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The International Comparative Legal Guide to: A practical cross-border insight into patent law Published by Global Legal Group, in association with CDR, with contributions from: Advokatfirman Lindahl KB Agency TRIA ROBIT AnJie Law Firm Armengaud & Guerlain Bird & Bird LLP Chuo Sogo Law Office, P .C. Daniel Legal & IP Strategy De Beer Attorneys Elzaburu Finnegan, Henderson, Farabow, Garrett, and Dunner LLP Gilat, Bareket & Co. Gleiss Lutz Gorodissky & Partners (Ukraine) Gros & Waltenspühl Gün + Partners Kadasa & Partners Lewis Roca Rothgerber Christie LLP Nestor Nestor Diculescu Kingston Petersen OLIVARES Pham & Associates PORZIO ∙ RIOS ∙ GARCIA Reinhold Cohn & Partners Reising Ethington P .C. Rouse & Co. International Subramaniam & Associates SyCip Salazar Hernandez & Gatmaitan TIPLO Attorneys-at-Law WhitneyMoore Solicitors Wikborg Rein Advokatfirma AS 8th Edition Patents 2018 ICLG

Transcript of 8th Edition - ACC

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The International Comparative Legal Guide to:

A practical cross-border insight into patent law

Published by Global Legal Group, in association with CDR, with contributions from:

Advokatfirman Lindahl KBAgency TRIA ROBITAnJie Law FirmArmengaud & GuerlainBird & Bird LLPChuo Sogo Law Office, P.C.Daniel Legal & IP StrategyDe Beer AttorneysElzaburuFinnegan, Henderson, Farabow,Garrett, and Dunner LLPGilat, Bareket & Co.Gleiss LutzGorodissky & Partners (Ukraine)Gros & Waltenspühl

Gün + PartnersKadasa & PartnersLewis Roca Rothgerber Christie LLPNestor Nestor Diculescu Kingston PetersenOLIVARESPham & AssociatesPORZIO ∙ RIOS ∙ GARCIAReinhold Cohn & PartnersReising Ethington P.C.Rouse & Co. InternationalSubramaniam & AssociatesSyCip Salazar Hernandez & GatmaitanTIPLO Attorneys-at-LawWhitneyMoore SolicitorsWikborg Rein Advokatfirma AS

8th Edition

Patents 2018

ICLG

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Further copies of this book and others in the series can be ordered from the publisher. Please call +44 20 7367 0720

DisclaimerThis publication is for general information purposes only. It does not purport to provide comprehensive full legal or other advice.Global Legal Group Ltd. and the contributors accept no responsibility for losses that may arise from reliance upon information contained in this publication.This publication is intended to give an indication of legal issues upon which you may need advice. Full legal advice should be taken from a qualified professional when dealing with specific situations.

The International Comparative Legal Guide to: Patents 2018

General Chapters:

Country Question and Answer Chapters:

1 Preparing for the Unitary Patent and Unified Patent Court: What to Consider Before Opting Out or Opting to Stay In – Katharine Stephens & Audrey Horton, Bird & Bird LLP 1

2 Method Claiming in the United States: The Who, What, and Where of Enforcement – Scott A. Hogan & Shannon K. Smith, Reising Ethington P.C. 7

3 U.S. Supreme Court Agrees Upon Restricted Venue for Patent Cases – D. Stuart Bartow & Terry Ahearn, Lewis Roca Rothgerber Christie LLP 11

4 Review of the Eurasian Patent System – Maxim Sobolev, Rouse & Co. International (UK) Limited (Moscow Branch) 15

5 Gulf Co-operation Council Countries – Patent Landscape – Sara Holder & Mohammad Jomoa, Rouse & Co. International/Kadasa & Partners 19

6 Australia Bird & Bird LLP: Jane Owen & Rebecca Currey 22

7 Brazil Daniel Legal & IP Strategy: Rana Gosain & André Bastos Venturini 28

8 Chile PORZIO ∙ RIOS ∙ GARCIA: Cristóbal Porzio & Marcelo Correa 36

9 China AnJie Law Firm: Steve Song & Ying Wang 42

10 France Armengaud & Guerlain: Catherine Mateu 49

11 Germany Gleiss Lutz: Dr. Matthias Sonntag & Dr. Herwig Lux 56

12 India Subramaniam & Associates: Hari Subramaniam 62

13 Ireland WhitneyMoore Solicitors: Aoife Murphy & Robin Hayes 70

14 Israel Gilat, Bareket & Co.: Eran Bareket Reinhold Cohn & Partners: Ronnie Benshafrut 77

15 Japan Chuo Sogo Law Office, P.C.: Naoko Nakatsukasa 84

16 Latvia Agency TRIA ROBIT: Vladimir Anohin & Voldemars Osmans 91

17 Mexico OLIVARES: Alejandro Luna Fandiño & Sergio Luis Olivares Lobato 96

18 Norway Wikborg Rein Advokatfirma AS: Gunnar Meyer & Lars Erik Steinkjer 104

19 Philippines SyCip Salazar Hernandez & Gatmaitan: Enrique T. Manuel & Vida M. Panganiban-Alindogan 110

20 Romania Nestor Nestor Diculescu Kingston Petersen: Ana-Maria Baciu & Sorina Olaru 116

21 Russia Rouse & Co. International (UK) Limited (Moscow Branch): Maxim Sobolev & Andrey Cherkasov 121

22 Saudi Arabia Rouse & Co. International/Kadasa & Partners: Sara Holder & Mohammad Jomoa 127

23 South Africa De Beer Attorneys: Elaine Bergenthuin & Ntombovuyo Bungane 133

24 Spain Elzaburu: Colm Ahern 140

25 Sweden Advokatfirman Lindahl KB: Ludvig Holm & Annie Kabala 145

26 Switzerland Gros & Waltenspühl: Pascal Fehlbaum 151

27 Taiwan TIPLO Attorneys-at-Law: J. K. Lin & H. G. Chen 157

28 Turkey Gün + Partners: Selin Sinem Erciyas & Tuğçe Avcısert Geçgil 165

29 Ukraine Gorodissky & Partners (Ukraine): Nina Moshynska 173

30 United Arab Emirates Rouse & Co. International: Sara Holder 180

31 United Kingdom Bird & Bird LLP: Katharine Stephens & Audrey Horton 185

32 USA Finnegan, Henderson, Farabow, Garrett, and Dunner LLP: Mareesa A. Frederick & Clara N. Jiménez 195

33 Vietnam Pham & Associates: Pham Vu Khanh Toan 202

Contributing EditorKatharine Stephens, Bird & Bird LLP

Sales DirectorFlorjan Osmani

Account DirectorOliver Smith

Sales Support ManagerPaul Mochalski

Sub EditorNicholas Catlin

Senior EditorsSuzie Levy, Rachel Williams

Chief Operating OfficerDror Levy

Group Consulting EditorAlan Falach

PublisherRory Smith

Published byGlobal Legal Group Ltd.59 Tanner StreetLondon SE1 3PL, UKTel: +44 20 7367 0720Fax: +44 20 7407 5255Email: [email protected]: www.glgroup.co.uk

GLG Cover DesignF&F Studio Design

GLG Cover Image SourceiStockphoto

Printed byAshford Colour Press Ltd.August 2017

Copyright © 2017Global Legal Group Ltd.All rights reservedNo photocopying

ISBN 978-1-911367-70-3ISSN 2044-3129

Strategic Partners

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EDITORIAL

Welcome to the eighth edition of The International Comparative Legal Guide to: Patents.

This guide provides corporate counsel and international practitioners with a comprehensive worldwide legal analysis of patent laws and regulations.

It is divided into two main sections:

Five general chapters, analysing recent developments in patent law in the United States and Europe, and offering an insight into the patent landscape in the Eurasia region and Gulf Co-operation Council countries.

Country question and answer chapters. These provide a broad overview of common issues in patent laws and regulations in 28 jurisdictions.

All chapters are written by leading patent lawyers and industry specialists, and we are extremely grateful for their excellent contributions.

Special thanks are reserved for the contributing editor Katharine Stephens of Bird & Bird LLP for her invaluable assistance.

Global Legal Group hopes that you find this guide practical and interesting.

The International Comparative Legal Guide series is also available online at www.iclg.com.

Alan Falach LL.M.Group Consulting EditorGlobal Legal [email protected]

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Chapter 1

Bird & Bird LLP

Preparing for the Unitary Patent and Unified Patent Court: What to Consider Before Opting Out or Opting to Stay In

Court has reached a decision in the expedited proceedings relating to the action. Germany also cannot notify its consent to the Protocol on Provisional Application until the Constitutional Court has ruled on the current challenge. This will delay the start of the provisional application phase and thereby the selection, appointment, education and training of judges. As a result, there will need to be a time interval of around six months between the German judgment and the doors of the UPC being opened in order to allow the necessary administrative arrangements to be put in place. Assuming that the UK and Germany ratify the UPC Agreement in the course of 2017, it is at present anticipated that the UPC will open for business in the middle of 2018. However, uncertainties as result of the German constitutional challenge and the UK Brexit vote could mean the start date is yet again delayed. In view of the new options for obtaining Unitary patents and tactics for litigating patents in Europe offered by the forthcoming UPC system, patentees are advised to develop a strategy for the management of their portfolio sooner rather than later.

Potential Filing Strategies: Unitary Patent, European Patent or National Patent?

The Unitary patent will be a new intellectual property right sitting alongside the present system of European patents and national patents. The Unitary patent will, in all respects, be a European patent for purposes of filing and prosecution, but within 30 days after grant by the European Patent Office, the patentee will have the option to designate it as having unitary effect. In such a case, the Unitary patent will provide uniform patent protection and equal legal effect in all the Member States which have ratified the UPC Agreement (the “Contracting Member States”). A clear advantage of the Unitary patent is that it will cover all Contracting Member States in terms of infringement including injunctive relief, but this central enforcement must be balanced against its vulnerability to central revocation. This is in contrast to the current system for litigating European patents; patentees must enforce their patents on a country-by-country basis with all the associated costs, time delays and potentially conflicting decisions inherent in taking such piecemeal action. On the other hand, depending on the facts, the current system allows patentees to choose where they want to take action, that is, it allows for a certain amount of forum shopping. It also means that, unless an opposition is brought in the European Patent Office within nine months of the grant of the European patent, each designation has to be invalidated country by country.

Before the new Unitary Patent Package comes into force, patent owners will have to take two key decisions: what strategy to adopt for the management of their portfolio to take account of the new Unitary patent; and secondly, whether to opt some or all of their existing European patents out of the jurisdiction of the new Unified Patent Court.

The Present State of Play

The Unitary Patent Package, made up of the Unitary patent and Unified Patent Court (the “UPC”), will become a reality on the date of entry into force of the Agreement on the Unified Patent Court (the “UPC Agreement”). This will be on the first day of the fourth month after the thirteenth Member State has deposited its instrument of ratification to the UPC Agreement; the 13 must include the UK, France and Germany. As of the date of writing (July 2017), the following countries have ratified the UPC Agreement: Austria; Belgium; Bulgaria; Denmark; Estonia (although it is yet to deposit the instrument); Finland; France; Italy; Luxembourg; Malta; the Netherlands; Portugal; and Sweden. Germany, Greece, Latvia, Lithuania and Slovenia have parliamentary approval, but have yet to deposit their notification of ratification with the Council of the European Union. Two key players, the UK and Germany, have not yet ratified.In the UK, delay was caused by the Brexit referendum vote of June 2016 after which, on 29 March 2017, the UK initiated the two-year exit procedure envisaged by Article 50 of the Treaty of the European Union. Despite this, the UK indicated in November 2016 that it would ratify the UPC Agreement. Secondary legislation to give the UPC its legal personality in the UK, the UPC (Immunities and Privileges) Order 2017, has been laid before the Westminster Parliament (a similar instrument needs to be laid before the Scottish Parliament) and, once they have passed, the UK will be able formally to ratify the UPC Agreement. However, absent renegotiation of the UPC Agreement, the UK, when it exits the EU not earlier than March 2019, will not be able to participate in the UPC system, which only applies to participating EU Member States. For the majority of potential users of the UPC, the system will be less valuable without the participation of the UK. It is, therefore, hoped that the goodwill of all those involved in the project will overcome any political obstacles preventing amendments or further agreements to facilitate the UK’s continuing involvement. In Germany, delay in the ratification process has been caused by a legal challenge brought by an anonymous individual before the Federal Constitutional Court. As a result, Germany has suspended formal ratification of the UPC Agreement until the Constitutional

Katharine Stephens

Audrey Horton

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A Brief Description of the UPC

The UPC system is unique and unusual in that, for the first time in the EU, a comprehensive court system, substantive law and procedural rules are being created from the beginning, starting as it were from a blank page. The creation of a brand new court system, rather than the use or adaptation of existing national court systems, has meant the development of a system which is suitable for the internet age. Litigation will be conducted online from the initiation of proceedings and at every stage afterwards using online forms. The Court of First Instance of the UPC will comprise local and regional divisions, which will primarily hear patent infringement cases, and a central division dealing with the validity of patents. Contracting Member States can either host a local division or participate in a regional division with other Contracting Member States. Local divisions have been announced so far in Austria, Belgium, Germany (which will have four local divisions), Denmark, the UK, Greece, Ireland, Italy, France, Finland and the Netherlands. There will also (at the present time) be one regional division: the Nordic-Baltic division comprising Estonia, Latvia, Lithuania and Sweden. Contracting Member States may also choose not to have a local or regional division, in which case all infringement cases in their territory will be heard in the central division. While it is true that the UPC system is untried and untested, with at least initially the risk of unpredictable decisions, participants in the new system will, from the outset, have the ability to shape and influence the first UPC decisions.The central division will have its seat in Paris and will have two specialist sections; one in London and one in Munich. Cases will be allocated to each section of the central division according to technology sector as defined by the International Patent Classification applied to the patent. London will hear cases relating to chemistry, including pharmaceuticals and life sciences (patents classified under IPC classes A and C). Munich will hear cases relating to mechanical engineering (IPC class F). All other cases will be heard by the central division in Paris.The UPC Agreement also allows forum, or rather division, shopping. Infringement cases must be filed and heard before the local and regional divisions where the actual or threatened infringement has occurred or where the defendant, or one of the defendants, has its residence, or principal place of business or, if none, place of business. Actions against multiple defendants will only be allowed where the defendants have a commercial relationship and where the action relates to the same infringement. Nevertheless, this will often give a claimant broad scope for choosing which division to use and which defendants to join.As a consequence, it might be possible to exploit, at least in the early days of the UPC, what has been referred to as the “couleur locale”; that is, different panels of judges in different divisions may, despite the fact that they should strive to apply the same procedures and substantive law, interpret the UPC Agreement and the Rules of Procedure differently, in part informed by their background and experience. For example, in cases where taking samples, or seizing products or documents for evidence is a priority, parties could, where appropriate, select divisions where the judges are familiar, from their national legal systems, with the saisie procedure, such as France or Belgium. Similarly, divergent approaches to confidentiality likely as a result of different national procedures may encourage parties to opt for those divisions known to be more familiar with the preservation of confidential materials in court proceedings. Different approaches are also possible in relation to the criteria for the grant of a number of remedies. One example might be in relation to ex parte injunctions which are rarely, if ever, granted in the UK and are more common in civil law countries such as

Since Unitary patents can be invalidated in a single, central attack, patentees should consider using this route for strong patents where there is no doubt as to their validity and where protection is required across Europe; for example, pharmaceutical compounds. They can then be used offensively to obtain injunctions, including preliminary injunctions, in all Contracting Member States. An important consideration to bear in mind is that Unitary patents will be subject to the mandatory exclusive jurisdiction of the UPC and cannot be opted out. European patents will also be subject to the jurisdiction of the UPC but, during a transitional period (see below), European patents can be opted out of the UPC’s jurisdiction and litigated in the national courts. When an action is brought before the UPC in respect of a bundle of European patents, one single judgment will cover all designated patents in Contracting Member States which are joined in the action. It can therefore be much more efficient for a patentee with a European patent granted in a number of Contracting Member States to obtain a judgment through the UPC.For patentees intending to obtain patent protection in five or more Contracting Member States, the Unitary patent will be cheaper than the equivalent European patent. There will be no validation fees for Unitary patents as there are with European patents and a proprietor will only have to translate the text into, at most, one additional language (other than the language of the European Patent Office procedure). Renewal fees will be the equivalent of national fees for the so-called “top four”, that is, Germany, France, the UK and the Netherlands, in return for which patent protection will cover all countries which have ratified the UPC Agreement at the date of grant (currently as at July 2017, 13 Member States but it will be more by the time the UPC Agreement enters into force). On the other hand, it will not be possible to save renewal fees by abandoning individual designations in one or more countries later in the patent’s life as can be done with European patents.Alternatively, national patents may be appropriate if a patent is only needed in a few jurisdictions in Europe, for example, where a patent is relevant to a product developed for a particular market. National patents might also be appropriate where a product has been developed for the whole of the EU, but is too valuable a right to countenance central attack. The cost and speed of obtaining patents may also be a factor. The European Patent Office can be slow and costly in comparison to some national patent offices where the procedures are far less burdensome; for example, in Belgium, France and Italy.National patents can also be used in tandem with Unitary patents in countries such as Germany where double patenting will be possible. This will allow patentees to test the waters first in the speedy German national court system allowing them to flush out prior art and judge the strength of potential attacks on the patent before venturing into the arena of the UPC where there is a risk of central revocation. If the patent survives any validity challenges, the patentee can follow up the national action by filing an action based on the Unitary patent in the local division of the UPC which will allow much wider enforcement. A further factor to consider is the uncertainty, following Brexit, about the UK’s participation in the UPC system. If the UK leaves the UPC system, it is possible that transitional arrangements would convert existing Unitary patents to European patent status in respect of the UK, and that might mean additional renewal fees without any reduction in the Unitary patent fees.Therefore, it makes sense to consider the possible advantages and disadvantages of the UPC before making a decision about whether to choose Unitary patent protection versus the traditional European patent or national patent route.

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■ The UPC is aiming for, and should result in, high-quality judgments. Local and regional divisions of the UPC will consist of panels of three judges (four if a technical judge is added to the panel) and many will be highly respected judges from national courts. Where countries are less experienced in patent litigation, the rules provide that two of the three legal judges will be from countries where judges are experienced in patent litigation.

■ An extensive range of evidentiary procedures will be available, including search and seizure orders (“saisies”), specific discovery and cross-examination of witnesses and experts.

■ Proceedings are intended to be fast, with actions to be heard within one year and hearings to be limited to one day.

■ Most divisions of the UPC will permit proceedings to be in English except in the case of revocation actions where the language of the patent must be used and the patent is in French or German or, in local and regional divisions, where the small local operator rule applies.

■ As only one action is necessary for all Contracting Member States, this avoids duplication of actions, court and legal fees. It should, however, be noted that the UPC is intended to be self-funding and court fees are high, compared with most national court systems. Infringement actions and actions for a declaration of non-infringement will have fixed court fees of €11,000, and revocation actions will have fixed court fees of €20,000. Additional, value-based fees will also apply to infringement actions and actions for a declaration of non-infringement for those actions with a value of over €500,000, rising on a sliding scale, to €325,000 for actions valued at over €50,000,000.

■ Damages will be available in respect of infringements in all Contracting Member States, and, where the defendant is domiciled outside the EU, the UPC also has (under Article 71b(3) of the Brussels I Regulation (recast)) “long-arm jurisdiction” in respect of damage arising outside the EU from infringements inside the EU.

■ Generally, the losing party will pay the winner’s (capped) legal costs. The value of the action estimated by the claimant at the outset of the action will be used to determine the ceiling of recoverable costs of the successful party. These ceilings are set at €38,000 for proceedings with a value or up to and including €250,000, rising to €2,000,000 for proceedings with a value of more than €50,000,000. The ceiling may be raised in some instances for particularly complex cases, but cannot exceed the maximum of €7,000,000.

Despite these advantages, there are some points against the UPC which may prove decisive for certain parties when considering their strategy. Firstly, as noted above, the UPC will be a strong court and will not be afraid to revoke patents when it finds them invalid. For those with weak patents, the UPC would best be avoided.Another example surrounds the uncertainty over whether the UPC will be able to grant the full set of remedies used by a national court; in particular, there is a question mark over what declarations it can make. The UPC Agreement provides that the UPC can grant declarations of infringement and non-infringement, but no mention is made of other declarations. Uncertainty therefore surrounds remedies such as a fair, reasonable and non-discriminatory (“FRAND”) declaration linked to a global licence, recently granted in the UK in Unwired Planet v Huawei. This may mean that there is a preference for bringing proceedings based on national or opted-out European patents in the UK courts. Similar considerations will apply in relation to Arrow declarations which are recognised in the UK (by the Court of Appeal in Fujifilm v AbbVie) which may or may not be granted in the UPC system. Arrow declarations are a discretionary remedy which may be used to clear the way in cases where, because the patents potentially blocking a new product or process are not yet granted, a declaration of non-infringement

Germany, France, the Netherlands, Belgium and Italy, leading to potential forum shopping in that respect also. One of the major concerns that has been expressed in relation to the UPC system is the ability of bifurcate patent actions. Bifurcation of patent actions is at present possible in national systems in Germany, Austria and Hungary. It means that there is the potential for an “injunction gap”, which refers to the concern that weaker patents could be pushed through the infringement divisions quickly, leading to injunctions that benefit from presumed patent validity.Bifurcation in the UPC system can arise when there is a counterclaim for invalidity in an infringement action, which then allows the local or regional division to decide which of four ways forward it should adopt, that is:■ keep both sides of the case;■ refer the counterclaim for invalidity to the central division

and proceed with the infringement action;■ refer the counterclaim for invalidity to the central division

and suspend the infringement action; or■ refer, where all parties agree, the whole case to the central

division.The possible impact and frequency of bifurcation should not, however, be overstated. The Rules of Procedure have made commendable attempts to limit the risk of abuse or at least to build in additional checks. Firstly, they have restricted the discretion allowed to the panel of the local or regional division; if the panel bifurcates the action, it has the discretion to stay the infringement action, but it must stay it if there is a high likelihood that the patent will be held invalid. Secondly, when the invalidity action is referred to the central division, it must accelerate the action. In this way, it is hoped that a decision on validity will be heard before the case on infringement. Finally, before giving judgment in a bifurcated case, the panel hearing the infringement action must again consider staying its decision or give judgment under a condition subsequent upon the invalidity decision. Conditions may include the rendering of security by the patentee before the order granting an injunction is binding.It is possible that, over time, certain local or regional divisions may become known as pro-patentee or pro-defendant such that parties will attempt, so far as possible, to forum shop according to the perceived bias of the division, although the allocation of judges from different countries to the panels may militate against such a bias in any one division. Furthermore, with time, the Court of Appeal will ensure that any differences in interpretation of the Rules of Procedure arising between divisions will be ironed out.While it is true that the UPC system is untried and untested with, at least initially, the risk of unpredictable decisions, participants in the new system will, from the outset, have the ability to shape and influence the first UPC decisions.

Potential Advantages and Disadvantages of the UPC

In drafting the Rules of Procedure for the UPC, the Preparatory Committee has tried to take the best aspects from civil and common law countries and has sought the input of users, practitioners and judges experienced in patent law and procedure. For a detailed account of the procedures of the UPC see chapter 1 of The International Comparative Legal Guide to: Patents 2017, A Guide to Conducting an Action before the Unified Patent Court, by Katharine Stephens.Advantages of the UPC system include the following:■ Patentees will have the ability to apply for both provisional

and permanent injunctions for all Contracting Member States, backed up by penalty payments for breach.

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Preparing for the Unitary Patent and Unified Patent Court

opt-out cannot be made if an action has been commenced before the UPC, irrespective of whether the action has been concluded or not.

Sunrise Period for Opt-Outs

If a patentee wishes to retain the ability to take the national route and avoid any pre-emptive central invalidity attack being made by a competitor, they would be well advised to opt out as soon as possible. Before the UPC opens its doors, there will be a sunrise period so that patentees can lodge their applications to opt out of the jurisdiction. Without such a period, the system would have been overwhelmed on day one and, during the time taken to process opt-out applications, some patents would have been vulnerable to a potential central attack even though their owners wanted to opt out, since the UPC Agreement states that the opt-out only takes effect upon its entry into the Register. The sunrise period for opt-outs is a purely administrative matter and so could start any time; however, it is only likely to start once Germany and UK have ratified the UPC Agreement, which possibly means that it will start at the beginning of 2018.

Withdrawing an Opt-Out: “Opting In”

At any time, unless an action has been brought before a national court, the proprietors or applicants of a European patent who made use of the opt-out can withdraw it. Again, the withdrawal of the opt-out is only effective once it has been entered on the Register. Only one opt-out is allowed; once a European patent has been opted back in, no further opt-out can be made. However, this will still allow proprietors some flexibility. They can opt out to begin with to avoid a central invalidity attack with the option, at a later date, of opting back in if they wish to bring a central infringement attack.If an action is started in a national court over a European patent, there will be no possibility of opting back in thereafter whatever the outcome of the litigation; whether the action is finished with no possibility of any appeal, settled or withdrawn, the effect is the same. The Preparatory Committee noted that the right to opt out will be “used and exhausted” after the first opt-out.As noted, an application for a European Patent can be opted out. If it proceeds to grant with unitary effect, the opt-out shall be deemed to be withdrawn. However, since the request for a patent to have unitary effect requires a positive step, this will be unlikely to catch anyone out.

Uncertainties in Relation to the Transitional Provisions

The UPC Agreement, in relation to the transitional provisions, is not well written, which makes challenges likely at the outset. In particular, a question mark has been raised over whether the transitional provisions provide for the complete ousting of the jurisdiction of the UPC. This arises through the use of the word “exclusive” in Article 83(3) of the UPC Agreement, which states: “a proprietor … shall have the possibility to opt out from the

exclusive competence of the Court.” Therefore, the argument goes, if the opt-out is only an opt-out from the exclusive jurisdiction of the UPC, that would mean that, during the transitional period, the UPC has exclusive jurisdiction over European patents until an opt-out is triggered, after which they will be subject to the non-exclusive jurisdiction of the national courts.

would not be available. Such declarations provide that the intended product or process was known or obvious at the priority date of the patent application of concern. Finally, national law may provide broader protection for a defendant in certain instances; for example, the UPC Agreement adopts a minimum standard for the experimental use defence, often known as the Bolar exemption, whereas many Contracting Member States have adopted broader defences. This may lead to defendants being in the extremely unattractive position of knowing that, at present, if an action were to be brought in a national court, their products would not infringe, but that, if the same action were brought before the UPC, they might be held to infringe.

Transitional Provisions

When the UPC Agreement comes into force, all traditional European patents will be subject to the jurisdiction of the UPC. This means that central attacks on the validity of European patents will be possible in the same way as for Unitary patents. As the UPC Agreement changes the ground rules considerably, it was recognised that transitional provisions were needed for existing European patents and applications. Article 83 of the UPC Agreement therefore provides that, during the transitional period:■ the UPC will have jurisdiction co-existing with national

courts over all European patents granted in Contracting Member States; and

■ a proprietor can opt out its granted European patents and applications for European patents from the jurisdiction of the UPC.

The transitional period is seven years and can be extended by the Administrative Committee following a consultation of the users by up to another seven years. By opting out its European patents, a patentee can avoid the jurisdiction of the UPC and therefore have the certainty that only the national courts will have jurisdiction. If a patentee does not opt its European patent out of the UPC system during the transitional period, an action can be started before either a national court or a division of the UPC.

How to Opt Out

The procedure for lodging an application to opt out is governed by Rule 5 of the Rules of Procedure. The application has to be made by all the proprietors (or applicants) for all Contracting Member States for which the European patent is designated. The opt-out provisions apply to European patents, published applications and expired European patents. An opt-out will cover all national designations of a particular patent owned by the proprietor or proprietors. It does not, however, apply to divisionals; divisional patents are separate patents to the parent patent and therefore a separate opt-out has to be lodged in relation to each one.A question mark was raised as to whether the opt-out applied to a particular patent only for the transitional period or whether the opt-out was for the lifetime of the patent. The better view is that it is for the lifetime of the patent, i.e. once the patent has been opted out, it remains opted out and subject always to the jurisdiction of the national courts (that is unless and until it is opted back in). The opt-out, therefore, lasts for the lifetime of the European patent and beyond, as it includes the time that the patent has expired, lapsed or been withdrawn.A European patent (or application therefor) can be opted out at any time up to the very last day of the transitional period. However, an

Bird & Bird LLP

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Preparing for the Unitary Patent and Unified Patent Court

The parties to any patent licence or development agreement should also be aware of the provisions relating to who can be a party to an action before the UPC. Many agreements make specific arrangements as to the conduct of litigation, but some do not. Article 47 of the UPC Agreement states that:■ unless the agreement provides otherwise, an exclusive

licensee shall be entitled to bring actions in the same circumstances as the patentee, provided notice is given to the patentee; and

■ a non-exclusive licensee can bring an action if the agreement expressly provides for it and notice is given.

As noted above, starting an action in either the UPC or a national court can fix the European patent in one or other system. As with the application to opt out, licensees and patentees should decide, in advance, what tactics they should follow, given that there may be some tension between them; an exclusive licensee would be more interested in being in the UPC system because it would benefit from the wide injunction, whereas a patentee might be more interested in preserving the patent and therefore want to protect it as best as possible from a central invalidity attack by opting it out of the UPC system. What both parties should avoid is being surprised by the action of the other which has consequences which cannot be undone and which they would prefer to avoid.

The Impact of Brexit

The question of whether the UK can continue to participate in the Unitary patent and UPC system after leaving the EU is a complex issue. The process of exiting the EU commenced on 29 March 2017 when the UK triggered Article 50 of the Treaty on European Union. The procedure will take at least two years to complete, which means that the earliest date on which the UK can officially leave the EU would be 29 March 2019. As a result the UPC, including the London central division, will open for business and the EPO may commence granting Unitary patents at a time when the UK remains a member of the EU. The precise impact of the UK then leaving the EU, currently expected in the course of 2019, is not clear. It is to be hoped that the UK government would not ratify the Agreement without at least the intention of long-term participation by the UK in the UPC system.Article 84 of the UPC Agreement expressly states that the UPC is limited to participation by Member States. Therefore, most commentators have concluded that the UPC Agreement would have to be amended or a new international agreement would have to be negotiated in order to accommodate the UK after its withdrawal from the EU.The Unitary Patent Regulation, the instrument of EU law which created the Unitary patent, would also require amendment. Such an international agreement would therefore have to replicate the wording of the Unitary Patent Regulation, including for example the provisions on exhaustion of rights, since inconsistencies would be incompatible with the concept of a Unitary patent providing uniform protection and having equal effect in all participating Member States. In practice, the UK’s participation in the Unitary patent would also be conditional on the UK’s participation in the UPC Agreement, since Unitary patents cannot function effectively unless disputes are decided by a single court system across all Contracting Member States.The UK Government’s White Paper, “Legislating for the United Kingdom’s withdrawal from the European Union” states that after Brexit, domestic UK courts will no longer be required to follow the jurisprudence of the Court of Justice of the EU (the “CJEU”). The UPC is not a domestic UK court, but an international or supranational court, separate from the EU. Importantly, under Article 20 of the

However, Article 83(1) clearly provides for alternative jurisdiction of national courts and the UPC during the transitional period regardless of whether there has been an opt-out. Furthermore, the Preparatory Committee drafting the Rules of Procedure has sought to allay such fears by stating that the provisions of Article 83 are clear and provide for a complete ousting of the jurisdiction of the UPC. The Interpretative Note published on 29 January 2014, in setting out this option, does not have any force of law, but the view of such an eminent Committee is likely to be extremely persuasive.

Strategic Considerations on Opting Out

To remove the risk of central revocation it may be advisable to opt out European patents which cover economically valuable products, or which are needed to protect high licensing revenue, but where the validity of such patents is uncertain. Once opted out, even if the patent is invalidated in one or two jurisdictions, it may be possible to retain validity in others.Where there are a number of patents protecting a single product, a possible strategy would be to leave one strong patent in the UPC system, to provide the means of obtaining a UPC injunction if required. Another criterion could be to leave those European patents already tested in opposition within the UPC system.Other possible strategies could involve a combination of parent and divisional patents in different categories. For example, having a parent patent with unitary effect (or an opted-in European patent) with a broad scope and a divisional or divisionals with a narrower scope but opted out. Such a strategy could be costly, but offer considerable safety to a patentee and possibly be suitable for very important products.Patentees should also be wary of giving their competitors too much information about the perceived relative strengths and weaknesses of patents in their portfolio through their opt-out strategy. Competitors and potential defendants will be monitoring the register of opt-outs through the UPC case management system, which is open to the public. Where patents are not opted out, they may then apply to revoke one or more of them centrally or where patents are opted out, defendants may grab the opportunity to start national proceedings in order to block such patents from being opted back in to the UPC system.

Considerations for Licensees and Licensors: Review Your Licences

Licensing, development and co-ownership agreements will, in particular, affect the right to opt out because the Rules of Procedure provide that only the proprietor (and, if there is more than one proprietor, all of them) can notify the decision to opt out. Existing licensing and development agreements will not have anticipated an opt-out regime, while many agreements give to exclusive licensees broad powers to decide about the maintenance and prosecution strategy of the licensed patents. To avoid unnecessary disputes, patentees and licensees should examine their existing agreements – in particular their exclusive licensing agreements – to determine who should take the decision on opting out; for example, the licensee may have been granted (at least implicitly) the right to impose on the patentee a decision on whether or not to opt out. Patentees who are currently negotiating a patent licence would be well-advised to negotiate a stipulation about who has the right to make/impose a decision about opting out, otherwise there could be disputes between licensees with exclusive rights on certain fields of application, or with rights in certain specific jurisdictions, whose interests will clash with other licensees, or with the patentee.

Bird & Bird LLP

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Preparing for the Unitary Patent and Unified Patent Court

the political problems of Brexit in the UK and the constitutional challenge in Germany intervened. Although there are a number of currently unanswered questions about what will happen as regards the UK’s participation in the UPC system when the UK leaves the EU after Brexit, the UK government has, to date, consistently indicated its intention to ratify the UPC Agreement. Furthermore, it has been stated that, from the little that is known about the grounds for the constitutional challenge in Germany, very few such cases are successful.On balance, therefore, it is likely that the UPC system will come into force during the course of next year and will thereafter survive in some form. Industry should therefore proceed with the preparations discussed in the article in relation to their patent-filing strategies, making decisions regarding opt-outs, reviewing ownership and licence agreements, and considering future litigation strategies.

UPC Agreement, the UPC must accept the supremacy of EU law in its entirety and this includes acceptance of competition law, fundamental rights arising under the Charter of Fundamental Rights of the EU and general principles of EU law, as well as specific patent rules in EU directives and regulations. Therefore, referrals to the CJEU could be required to be made in the course of patent litigation in the UPC. Politically, this aspect is likely to be problematic to the UK in the context of its continued participation in the UPC and the exit negotiations.

Conclusions

The UPC system has been the process of decades of negotiation and was in the very final stages of preparation to become a reality when

Bird & Bird LLP

Katharine StephensBird & Bird LLP12 New Fetter LaneLondon, EC4A 1JPUnited Kingdom

Tel: +44 20 7415 6000Fax: +44 20 7415 6111Email: [email protected]: www.twobirds.com

Audrey HortonBird & Bird LLP12 New Fetter LaneLondon, EC4A 1JPUnited Kingdom

Tel: +44 20 7415 6000Fax: +44 20 7415 6111Email: [email protected]: www.twobirds.com

Hailed by Managing IP as ‘IP Firm of the Decade’ in 2015 and ‘European Patent Firm of the Year’ in 2017, Bird & Bird consistently remains at the forefront of intellectual property law.

Particularly commended for its strength in IP strategy and litigation, it’s this first-class reputation that allows the firm to attract and retain world-leading patent advisors and litigators.

The majority of the firm’s work is cross-border in nature, and they are regularly called to advise on ground-breaking patent cases. Due to their geographic spread, they are also able to litigate in some of the most prominent patent litigation jurisdictions, providing invaluable experience on the approach and attitude of the courts in different jurisdictions, which enables them to devise and tailor litigation strategies accordingly.

Not only does the firm have the range and depth of expertise, but with more than 300 specialist lawyers across 28 offices, they have numbers in force.

www.twobirds.com

@twobirdsIP

Katharine Stephens is co-head of the London Intellectual Property Group, and has been a partner at Bird & Bird since 1999. She specialises in patent, trade mark and design litigation, often coordinating and running actions in more than one jurisdiction.

With a Master’s degree in Mechanical Engineering from Bristol University, Katharine has a particular interest in the electronic, computer technology and engineering sectors. Many of the patent actions which she has been involved in over the years concern standard essential patents and patent pools, and she is therefore experienced in dealing with the patent and competition law issues raised in such cases.

She is also experienced in designing and implementing European-wide protection and enforcement strategies based on trade marks and designs.

Katharine has been recognised as one of the ‘Top 250 Women in IP’ by Managing IP, a position which she’s held for the past two years, and is highly ranked across all areas of IP in the major legal guides. She reports each month on trade mark, copyright and design cases for the Chartered Institute of Patent Attorneys Journal.

Audrey Horton is a senior associate and IP Knowledge and Development Lawyer in Bird & Bird’s Intellectual Property Group, based in the London office.

Audrey’s practice covers the full spectrum of intellectual property rights, including patents, confidential information, trade marks, designs, copyright, and database rights. Her experience also encompasses drafting and negotiating contracts for the creation, transfer or licensing of intellectual property.

Audrey has written and lectured on a wide range of intellectual property topics, including industrial design rights, trade marks and passing off, research and development agreements, unfair competition law and IP-related jurisdictional issues. Her articles have been published in various journals, including the European Intellectual Property Review, the ITMA Review and Managing Intellectual Property. She is co-author of Practical Intellectual Property Precedents (Sweet & Maxwell) which is updated regularly.

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Chapter 2

Reising Ethington P.C.

Method Claiming in the United States: The Who, What, and Where of Enforcement

Watch Where You’re Stepping

When it comes to infringement of method claims, the location of performance of each recited step of the method matters. Under the direct infringement provisions of 35 U.S.C. § 271(a), courts have strongly suggested that method claims can only be infringed under the “use” prong – thus, to show infringement, a patentee must show that an accused process is used in the U.S.4 “[A] process cannot be used ‘within’ the United States . . . unless each of the steps is performed within this country.”5 In NTP, Inc. v. Research In Motion, Ltd., the Federal Circuit drew a line between system and method claims, citing In re Kollar for the premise that there is a “distinction between a claim to a product, device or apparatus, all of which are tangible items, and a claim to a process, which consists of a series of acts or steps. . . . [A process] consists of doing something, and therefore has to be carried out or performed”.6 NTP asserted infringement of various system and method claims relating to wireless transmission of emails for mobile devices.7 The defendant (RIM) successfully argued that, as a matter of law, there was no direct infringement of NTP’s method claims under section 271(a) since emails were relayed through Canada.8 Further, given that one of the method steps was performed extraterritorially, at least in part, there could be no contributory or induced infringement since there was no direct infringement.9 The court held that given the action-based, step-by-step nature of process claims, if one step is performed outside of the U.S., liability for direct infringement under 271(a) can be avoided, and accordingly, liability for contributory or induced infringement can also be avoided.10 The NTP decision further highlights how a seemingly subtle difference between a system claim and a method claim can lead to a stark difference in the outcome on the question of infringement: RIM was found to infringe NTP’s closely related system claims, even though a part of the accused system was located in Canada.11 The court found that the infringing activity was “use” of the system by RIM’s customers to retrieve emails from the system, and that this use occurred in the United States, regardless of the location of individual system components. In terms of claim language, the system claims required an “interface switch” from which certain information is transmitted to an RF network, while the method claims required the step of “transmitting” the same information to the RF network. Because RIM’s alleged interface switch was located outside the United States, the method step of transmitting was performed outside the United States, and the method was not infringed. NTP was fortunate to have pursued claims to a system that was capable of performing its patented method.

Patent-eligible subject matter in the United States is defined by statute to include “any new and useful process, machine, manufacture, or composition of matter”.1 The first of these categories has garnered an unusual amount of attention in recent years in the wake of the U.S. Supreme Court’s decision in Alice Corp. Pty. Ltd. v. CLS Bank Int’l.2 So-called business methods, which broadly fall into the statutory category of processes, are one of the primary types of subject matter becoming increasingly ineligible for patent protection under §101 jurisprudence. With inventors, patent owners, practitioners, courts, and the Patent Trial and Appeal Board at the USPTO so focused on trying to delineate the threshold that separates an abstract idea from a patent-eligible idea, it is easy to forget that patent eligibility is not the only area of the law under which method claims receive special treatment, particularly in the United States.Legal doctrines aside, method claims, by their nature, present special problems with enforcement by patent owners. Because these types of patent claims protect a particular manner or way of doing something, they present inherent evidentiary problems that product or composition claims normally do not. For example, a patent owner may find it difficult to know when its patented method of making a product is being performed without permission if the method is performed behind the closed doors of a competitor’s factory. This is in contrast to the relative ease of detecting when a patented product is being made, used, sold, or imported. In the case of product claims, a physical item usually exists and can likely be analysed for comparison to the patent claims – if the product in question is present in the United States and includes all of the elements recited in the claim, the patent owner is immediately aware of the existence of an infringing product.Enforcement of method claims becomes even more complex when individual steps of the method are performed in different locations or by different entities. Patent owners and practitioners are wise to consider these issues when drafting and prosecuting method claims or evaluating the scope of a potential adversary’s method claims. This is particularly true in today’s global marketplace. With trade accounting for about 20% of U.S. GDP,3 it is important to recognise implications involved when all or parts of manufacturing methods are performed abroad. For example, is a U.S. patent directed to a method of manufacturing infringed if the product manufactured by that method is imported into the U.S. from China, with various subcomponents being manufactured in other East Asian countries? And if so, where does infringement lie? This is only one realistic hypothetical scenario in which method claims present additional questions of who, what, and where that are not always posed with other types of patent claims.

Scott A. Hogan

Shannon K. Smith

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What Can You Make of This?

Hope is not all lost for patentees seeking to enforce method claims when a product is wholly or partially manufactured extraterritorially. Section 271(g) provides for infringement liability when a product made by a process patented in U.S. is used, sold, or offered for sale in the U.S.12 This section of the U.S. patent infringement statute was part of the Process Patents Amendments Act of 1988 and “was enacted to prevent infringers from avoiding United States patent laws by practicing a patented method in another country and then importing the resulting product into the United States”.13 Section 271(g) has two important caveats, however, and will not allow a patentee to enforce just any method claims. First, method claims asserted under section 271(g) must be directed to a process of making a product.14 Parties have avoided infringement by arguing that the asserted claims were directed to methods related only to an exchange of information, not the manufacture of a product.15 Further, methods of testing or refining a particular product may not be covered by section 271(g). In Momenta Pharmaceuticals, Inc. v. Teva Pharmaceuticals USA Inc., the Federal Circuit held that a method of analysing a pharmaceutical sample was not a product “‘made by’ a patented process within the meaning of § 271(g)”.16 The court described that “the ordinary meaning of ‘made’ as used in § 271(g) means ‘manufacture,’ and extends to the creation or transformation of a product, such as by synthesizing, combining components, or giving raw materials new properties”.17 The court relied heavily on Bayer AG v. Housey Pharmaceuticals Inc., in which the Federal Circuit held that “processes of identification and generation of data are not steps in the manufacture of a final drug product”.18

As opposed to information transmission methods or methods of analysing products, claims directed to methods of use or methods of making a digital product may be able to survive this scrutiny under section 271(g). Method of use claims may be asserted under section 271(g) if the use constitutes significant steps in the manufacture of the product.19 And, in contrast to methods involving the transmission of information, methods that involve making a digital product, such as an electronic catalog or a three-dimensional model, may be considered a product “made by” a patented process.20 A second caveat under section 271(g) involves a limited definition of “product”, in which liability may be avoided if the product “is materially changed by subsequent processes” or if the product “becomes a trivial and nonessential component of another product”.21 One strategy which may be used to avoid falling into this 271(g) exception involves providing examples of how a method may be used in the specification, including the types of end products the method is capable of producing. In OKI America, Inc. v. Advanced Micro Devices, Inc., imported semiconductor chips, which were allegedly processed using the patentee’s method of cleaning wafer edges, were the subject of section 271(g) litigation.22 The alleged infringer argued that the product (i.e., a cleaned wafer edge) is not directly involved in the fabrication or manufacture of a product.23 And further, numerous other wafer processing steps required for manufacture would constitute a material change.24 The court disagreed, holding that because the patent was directed to the production of a debris-free device, the claimed method of cleaning wafer edges could be asserted under section 271(g).25

Notably, because claims to methods of making a product are generally written to recite a series of process steps, they do not necessarily include all of the structural, spatial, or functional limitations of a corresponding product claim, particularly in the United States where a claimed product and a corresponding method of making the product are regularly treated as separate inventions under U.S. restriction practice. At least in theory, this means that

Reising Ethington P.C. Method Claiming in the United States

the characteristics of the imported product, the sale or use of which is the act of infringement, could be less defined than in a patentable product claim – i.e., as long as that product is made by the patented method, its use or sale in the U.S. could constitute infringement under section 271(g).

Whodunnit?

Yet another question that is more complex in the realm of method claims is the question of who the infringer is. While this question is of course important with product claims, at least to identify the party or parties responsible for providing the patent owner with relief from the harm of infringement, direct infringement under section 271(a) can be more difficult to prove when multiple actors separately perform different steps of a patented method. For instance, if one entity performs some of the steps of a patented method, and another different entity performs the remaining steps of the patented method, has the patent been infringed? Presumably, someone has benefited from the completed performance, but neither entity actually performed the entire method. This very quandary was played out in a decade-long battle between Akamai Technologies and Limelight Networks, culminating in an en banc opinion from the Federal Circuit.26 Throughout the dispute, defendant Limelight admitted that all of the steps of Akamai’s patented method were performed. However, at least one of the steps of the patented method was not actually performed by Limelight; rather, it was performed by various individual customers who had purchased Limelight’s services.27 Akamai sought to attribute those customers’ actions to Limelight, but Limelight maintained that the customers were acting independently, not under any contractual obligation or any other direction or control by Limelight.28 Along the way, the U.S. Supreme Court decided that section 271(b) could not be invoked to hold Limelight liable for infringement under a theory of inducement because, even if Limelight literally induced its customers to perform the missing method step, Limelight clearly did not induce its customers to directly infringe under section 271(a) since the customers only performed one step of a multi-step method.29 This essentially confirmed the long-understood rule that direct infringement must be found under section 271(a) for secondary liability under sections 271(b) or 271(c) to lie.30

In the end, Limelight was held accountable for its customers’ performance of the method step at issue under a somewhat broadened rule for what constitutes directing or controlling the actions of another entity in the context of method claims.31 The Akamai court finally concluded that “liability under § 271(a) can also be found when an alleged infringer conditions participation in an activity or receipt of a benefit upon performance of a step or steps of a patented method and establishes the manner or timing of that performance… In those instances, the third party’s actions are attributed to the alleged infringer such that the alleged infringer becomes the single actor chargeable with direct infringement”.32 This updated standard for when one actor’s actions are attributable to another appears to be designed to give courts more fact-specific latitude to hold an accused infringer liable when a third party performs a step of a patented method left unperformed by the accused infringer.To date, there are few examples from the Federal Circuit of the types of behaviour considered to meet the new standard for attribution. In Akamai, performance of the missing method step was attributed to Limelight because the customers’ use of the Limelight service was conditioned on performance of the step, and Limelight instructed customers how to perform it.33 In a post-Akamai Federal Circuit decision, the actions of a patient in performing the step of “administering” a folic acid pretreatment were attributed to a physician who performed the remaining steps of a patented method.34 In that case, the physician had conditioned

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13. Lubrizol Specialty Prod., Inc. v. Flowchem LLC, 165 F. Supp. 3d 534, 540 (S.D. Tex 2016) (citing Kinik v. Co. v. Int’l Trade Comm’n, 362 F.3d 1359, 1362 (Fed. Cir. 2004)).

14. 35 U.S.C. § 271(g).15. Home Gambling Network, Inc. v. Piche, Case No. 2:05-cv-

00610-DAE-VCF, 2013 WL 5492568 at *6 (D. Nev. Sept. 30, 2013) (holding that section 271(g) was inapplicable because the claims were directed to a method of transmitting information); NTP, 418 F.3d at 1323 (“[b]ecause the ‘transmission of information,’ like the ‘production of information,’ does not entail the manufacturing of a physical product. . . .”); Phillip M. Adams & Assocs., LLC v. Dell Computer Corp., 519 Fed. Appx. 998, 1005-06 (Fed. Cir. 2013) (non-precedential) (claims directed to motherboard certification testing methods were not covered under section 271(g)).

16. Momenta Pharmaceuticals, Inc. v. Teva Pharmaceuticals USA Inc., 809 F.3d 610, 617 (Fed. Cir. 2015).

17. Id. at 616. 18. Id. at 617. Id. at 616-17 (quoting Bayer AG v. Housey Pharm., Inc., 340

F.3d 1367, 1377 (Fed. Cir. 2003)).19. Anvik Corp. v. Sharp Corp., Case No. 07-cv-0825 (SCR),

2010 WL 11416949 at *5-*6 (S.D.N.Y. Aug. 11, 2010). 20. See CNET Networks, Inc. v. Etilize, Inc., 528 F. Supp. 2d 985,

992-94 (N.D. Cal. 2007) (denying a motion for summary judgment where the alleged infringer argued that a method for automatically creating an electronic catalogue was not covered under 271(g)); Ormco Corp v. Align Technology, Inc., 609 F. Supp. 2d 1057, 1076 (C.D. Cal. 2009) (denying a motion for summary judgment under 271(g) because a three-dimensional digital representation of teeth could be considered a creation produced by practising each step of a patented process); McRO, Inc. v. Namco Bandai Games America, Inc., 23 F. Supp. 3d 1113, 1121-23 (C.D. Cal. 2013) (an animation may constitute a product made by a method of manufacturing); but see Yangaroo inc. v. Destiny Media Technologies Inc., 720 F. Supp. 2d 1034 (E.D. Wisc. 2010) (distinguishing “a method of creating or manufacturing the digital content that is received in servers and then transmitted to authorized recipients” as in CNET or Ormco with the asserted “method of distributing content” and holding no infringement under section 271(g)).

21. 35 U.S.C. § 271(g)(1)&(2). 22. OKI America, Inc. v. Advanced Micro Devices, Inc., Case No.

C-04-03171 CRB, 2006 WL 27115555 at *12-*15 (N.D. Cal. Sept. 21, 2006).

23. Id. at *15. 24. Id.25. Id.26. Akamai Technologies, Inc. v. Limelight Networks, Inc., 797

F.3d 1020 (Fed. Cir. 2015).27. See, e.g., id. at 1024. 28. Id.29. Limelight Networks, Inc. v. Akamai Technologies, Inc., 134

S.Ct. 2111 (2014).30. See, e.g., NTP, Inc. v. Research In Motion, Ltd., 418 F.3d

1282, 1318 (Fed. Cir. 2005).31. Akamai, 797 F.3d at 1023 (Fed. Cir. 2015).32. Id.33. Id. at 1024–25. 34. Eli Lilly and Co. v. Teva Parenteral Medicines, Inc., 845 F.3d

1357 (Fed. Cir. 2017).35. Id. at 1365–67. 36. Akamai, 797 F.3d at 1023 (Fed. Cir. 2015); Eli Lilly, 845 F.3d

at 1368 (Fed. Cir. 2017).

the patient’s subsequent medical treatment on self-administering the folic acid pretreatment and had established the manner and timing by instructing the patient on when and how much folic acid to take.35 The Federal Circuit has explicitly indicated that the new standard is applicable to “other factual scenarios” not yet encountered.36

Whether to Address or Avoid the Questions that Arise with Method Claims

What are practitioners and patent owners to do with all of the additional questions posed by method claims? As always, this depends on which side of the courtroom you will be. In some cases it is prudent to avoid the additional questions when possible. For the attorney drafting or prosecuting method claims, it could pay to be thoughtful about whether a client’s potential competitors will actually perform all of the recited method steps to avoid having to attribute some third party’s actions to an accused infringer during subsequent litigation. While the Federal Circuit has effectively broadened liability under Akamai, the less tortuous path is careful claim drafting. For the attorney drafting a clearance opinion with respect to a method claim, a client’s performance of a single method step beyond the U.S. border can make for quick work. And while some of these doctrines can make method claims seem undesirable, section 271(g) offers enforcement options that effectively extend beyond U.S. borders. In any case, understanding the subtle but important differences between product and method claims is useful.

Endnotes

1. 35 U.S.C. § 101.2. Alice Corp. Pty. Ltd. v. CLS Bank Int’l., 573 U.S. __, 134 S.

Ct. 2347 (2014).3. Pankaj Ghemawat, Globalization: Myth and Reality, Harvard

Business Review (Feb. 24, 2017), available at https://hbr.org/ideacast/2017/02/globalization-myth-and-reality.

4. Cont’l Circuits LLC v. Intel Corp., Case No. CV16-2026 PHX DGC, 2017 WL 679116, at *7 (D. Ariz. Feb. 21, 2017) (“[T]he Federal Circuit has repeatedly declined to decide ‘whether method claims can be infringed under the ‘sells’ and ‘offers to sell’ prongs’ of the provision. W.L. Gore & Assocs. v. Medtronic, Inc., 874 F. Supp. 2d 526, 543 (E.D. Va. 2012). The Federal Circuit has, however, strongly suggested in dicta that they cannot. See NTP, 418 F.3d at 1320 (“[T]he legislative history of section 271(a) indicates Congress’s understanding that method claims could only be directly infringed by use.”).”).

5. NTP, Inc. v. Research In Motion, Ltd., 418 F.3d 1282, 1318 (Fed. Cir. 2005), abrogated with respect to other grounds by Avid Tech., Inc. v. Harmonic, Inc., 812 F.3d 1040 (Fed. Cir. 2016); see also Home Gambling Network, Inc. v. Piche, Case No. 2:05-cv-00610-DAE-VCF, 2013 WL 5492568 at *6 (D. Nev. Sept. 30, 2013) (holding that there was no infringement since one of the claimed steps was performed in Costa Rica).

6. NTP, 418 F.3d at 1317 (Fed. Cir. 2005) (quoting In re Kollar, 286 F.3d 1326, 1332 (Fed. Cir. 2002)).

7. Id. at 1287. 8. Id. at 1318.9. Id.10. Id. (citing Zoltek Corp. v. United States, 51 Fed. Cl. 829, 836

(Fed. Cl. 2002)). 11. Id. at 1317.12. 35 U.S.C. § 271(g).

Reising Ethington P.C. Method Claiming in the United States

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Scott A. HoganReising Ethington P.C.Suite 1850, 755 West Big Beaver RoadTroy, Michigan 48084USA

Tel: +1 248 689 3500Email: [email protected]: www.reising.co

Shannon K. SmithReising Ethington P.C.Suite 1850, 755 West Big Beaver RoadTroy, Michigan 48084USA

Tel: +1 248 689 3500Email: [email protected]: www.reising.co

Since its founding in Detroit in 1865, Reising Ethington has specialised solely in the practice of intellectual property (IP) law. Areas of expertise include IP prosecution and litigation, managing worldwide patent and trademark portfolios, post-grant proceedings, trade secrets, and licensing and other IP-related agreements. The firm represents some of the world’s most innovative and foremost IP owners, including automotive manufacturers and suppliers, medical technology companies, aerospace companies, universities, industrial equipment makers, robotics companies, and consumer product companies.

Dating back several decades, attorneys at Reising have authored seven editions of the U.S. law school textbook Patent Law Including Trade Secrets-Copyrights-Trademarks, published by West Publishing Co., and are currently preparing the eighth edition. Simply put, Reising provides world-class counselling to world-class clients.

Scott works together with clients to help them identify and protect their intellectual property while respecting the intellectual property of others. Having hands-on work experience across a broad spectrum of fields, from biopolymers and polymer solution chemistry to electric generators and automotive components, he is as at home at a university research symposium as he is on a manufacturing shop floor. With several U.S. and foreign patents to his name, he knows how exciting it can be to be an innovator or a small business owner because he has been both. Scott has been with Reising Ethington since 2007 and has developed expertise in a variety of technologies, including laser-based manufacturing processes, nanomaterials and nanotechnology, microfabricated devices, and automotive components, to name a few. His practice also encompasses other aspects of intellectual property with experience in trademark prosecution, opposition, and litigation, as well as copyright registration and licensing.

Shannon has assisted in the drafting and prosecution of patents in various arts including bio-medical, automotive, material science, and chemical. Shannon also has experience in trademark prosecution and litigation, and she has provided litigation support in patent matters. Shannon has had extensive education in drafting and interpreting intellectual property licensing agreements, and she has experience in performing intellectual property due diligence for corporate mergers and acquisitions. Shannon graduated from the University of Michigan in Ann Arbor with a Bachelor of Science degree in Neuroscience/Pre-Med, and then graduated first in her class from University of Detroit-Mercy School of Law in December 2013. She was admitted to practise law in Michigan in May 2014, and she has been a registered patent attorney with the USPTO since June 2015.

Reising Ethington P.C. Method Claiming in the United States

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Chapter 3

Lewis Roca Rothgerber Christie LLP

U.S. Supreme Court Agrees Upon Restricted Venue for Patent Cases

1400(b),2 due to Heartland’s lack of a “regular and established place of business” in Delaware. In the alternative, Heartland requested transfer to the U.S. District Court for the Southern District of Indiana, where Heartland’s headquarters are located.The Delaware court denied the motion, finding that jurisdiction over Heartland was proper because Heartland had “purposefully availed” itself of the privilege of conducting activities within Delaware by knowingly and intentionally shipping products to Delaware, thus invoking the benefits and protections of Delaware laws. Additionally, the district court relied on a 1990 decision of the U.S. Court of Appeals for the Federal Circuit, VE Holding Corp. v. Johnson Gas Appliance Co.,3 to find that the requirement of proper venue had been satisfied based merely on the existence of personal jurisdiction.Heartland then filed a petition for mandamus at the Federal Circuit, seeking a writ directing the Delaware court to either dismiss or transfer the case. Not surprisingly, the Federal Circuit relied on its prior decision in VE Holding in denying the writ. According to the Federal Circuit, the venue question had been “firmly resolved” by VE Holding more than 25 years beforehand. In that case, as discussed in greater detail below, the Federal Circuit had held that the broad definition of corporate residence in the general venue statute – which would encompass all jurisdictions in which the defendant corporation was subject to personal jurisdiction – was intended by Congress to be read into the special patent venue statute.With its attempt to obtain a writ of mandamus rejected, Heartland then filed a petition for writ of certiorari with the U.S. Supreme Court, which – to the surprise of many observers – was granted on December 14, 2016.

The Interplay Between the General and Patent-Specific Venue Statutes

The special venue statute for patents in U.S. patent law, 28 U.S.C. 1400(b), provides that “any civil action for patent infringement may be brought in the judicial district where the defendant resides, or where the defendant has committed acts of infringement and has a regular and established place of business”. This statutory text has remained largely unaltered since its original enactment in 1897.4 In 1942, the U.S. Supreme Court explicitly held that the special patent venue statute was the “exclusive provision controlling venue in patent infringement proceedings”. Stonite Products Co. v. Melvin Lloyd Co., 315 U.S. 561, 562 (1942). Stonite addressed the question whether a general venue provision – which permitted suits against two or more defendants residing in different districts within the same state to be brought in either district – supplemented the special venue statute, or whether the special patent venue statute was a

Introduction

In what may prove to be one of the most significant U.S. patent law decisions in recent years, the U.S. Supreme Court held in TC Heartland LLC v. Kraft Foods Group Brands LLC that domestic U.S. corporations may be sued for patent infringement only in federal districts in which they: (i) “reside” (i.e., within the U.S. state where they are incorporated); or (ii) have “committed acts of infringement” and have a “regular and established place of business”.1 This decision overturned 27 years of contrary practice, under which U.S. corporations could be sued in any district in which they were subject to personal jurisdiction – in other words, just about anywhere their business activities reached. The decision likely reduces the potential for forum-shopping in patent cases by restricting the number of jurisdictions in which a patentee may bring an infringement lawsuit against a domestic U.S. corporation. However, the decision also raises new questions about (i) what constitutes a “regular and established place of business”, and (ii) where foreign (i.e., non-U.S.) corporations can be sued. This article examines the history of the patent venue statutes, the effect of the TC Heartland ruling, and the issues that are expected to be the subject of near-term future litigation.

History of the Kraft Foods/TC Heartland Litigation

The case arose out of a dispute between Kraft Foods (“Kraft”), a major global food and beverage producer, and TC Heartland (“Heartland”), a smaller U.S. company selling competing flavoured water products. Kraft sued Heartland in the U.S. District Court for the District of Delaware, one of the most popular jurisdictions for patent cases, alleging infringement of three patents concerning packaging techniques for water flavourings. Heartland moved for dismissal of the action on the basis that the court lacked personal jurisdiction over Heartland. According to Heartland, no personal jurisdiction could be established because Heartland was not registered to transact business in Delaware and had no office, property, employees, agents, distributors, bank accounts, or other local presence in Delaware. Nor did it have any supply contracts there; nor did it call on any customer accounts there.The only connection between Heartland and Delaware – which Heartland conceded – was that a very small percentage of its accused products (on the order of 2 per cent) were shipped to customers’ distribution facilities in Delaware. Heartland also argued that venue was improper under the patent-specific venue statute, 28 U.S.C.

D. Stuart Bartow

Terry Ahearn

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United States and is not particularly known for being a hotbed of research and development, by 2015 had come to host nearly half the patent cases filed that year.6

One additional change bears noting. In 2011, Congress amended §1391 such that “except as otherwise provided by law”, “this section shall govern the venue of all civil actions brought in district courts of the United States. And 1391(c)(2) now provided that “[f]or all venue purposes”, certain entities, “whether or not incorporated, shall be deemed to reside, if a defendant, in any judicial district in which such defendant is subject to the court’s personal jurisdiction with respect to the civil action in question”. The Federal Circuit, in declining to issue a writ of mandamus in response to Heartland’s petition, determined that such amendments reflected a broadening of the applicability of the definition of corporate residence, not a narrowing, and rejected the argument that these amendments were intended to codify the holding of Fourco as opposed to VE Holding.And then came the Supreme Court’s grant of certiorari.

The Supreme Court’s Heartland Decision

The Supreme Court heard oral argument on March 27, 2017, and issued its decision on May 22, 2017. In a unanimous 8-0 opinion, the court reversed the decision of the Federal Circuit as to the Heartland matter, and abrogated the Federal Circuit’s determination in VE Holding that the general venue statute supplemented the specialised patent venue statute. As the court stated: In Fourco, this Court definitively and unambiguously held

that the word ‘residence’ in §1400(b) has a particular meaning as applied to domestic corporations: It refers only to the State of incorporation. Congress has not amended §1400(b) since Fourco, and neither party asks us to reconsider our holding in that case.

TC Heartland, 137 S.Ct. at 1520.Moreover, the court stated that “the current version of §1391 does not contain any indication that Congress intended to alter the meaning of §1400(b) as interpreted in Fourco”. And “nothing in the text suggest[ed] congressional approval of VE Holding”.Thus, the rule of Fourco and Stonite has been upheld once again: §1400(b), the specialised patent venue statute, is the exclusive provision governing venue in U.S. patent cases. Accordingly, a U.S. domestic corporation may only be sued in districts: (i) which are within the defendant’s state of incorporation; or (ii) in which the corporate defendant has committed acts of infringement and the defendant has a regular and established place of business.

Practical Implications and New Questions

The Supreme Court’s decision raises several new issues which likely will be litigated heavily in the near-term. First, since VE Holding issued in 1990, 27 years ago, courts have had little occasion to address what constitutes a “regular and established place of business”. The Federal Circuit only had one opportunity to weigh in on that question prior to VE Holding, and only then in a procedural posture that did not require to court to put much gloss on what the term means. To be sure, in the age of the Internet, the ways in which many companies conduct business has changed radically since VE Holding issued. Second, the Heartland decision expressly applies only to domestic corporations, which raises the question: what is the state of the law in respect of foreign (i.e. non-U.S.) corporations and other entities? With the caveat that these questions have not been definitively answered, we address each of these issues in turn below to provide some background.

stand-alone provision, not to be supplemented by any other venue statute. The Supreme Court reasoned: The Act of 1897 was adopted to define the exact jurisdiction

of the federal courts in actions to enforce patent rights and thus eliminate the uncertainty produced by the conflicting decisions on the applicability [of an earlier general venue statute]. That purpose indicates that Congress did not intend the [earlier statute] to dovetail with the general provisions relating to the venue of civil suits, but rather that it alone should control venue in patent infringement proceedings.

Stonite, 315 U.S. 565-56.Then, in 1948, in an effort to expand the number of locations in which corporate defendants could be sued in civil cases in general, the U.S. Congress enacted 28 U.S.C. 1391(c), which provided (at that time, fairly similar to today) that “[a] corporation may be sued in any judicial district in which it is incorporated or licensed to do business or is doing business, and such judicial district shall be regarded as the residence of such corporation for venue purposes”. In 1957, in addressing the apparent conflict between the new general provision of 1391(c) and the specialised patent venue statute, the Supreme Court again held that the specialised patent venue statute was “the sole and exclusive provision controlling venue in patent infringement actions, [and that it is] not to be supplemented by the provisions of §1391(c)”. Fourco Glass Co. v. Transmirra Products Corp., 353 U.S. 222, 229 (1957). As the court reasoned: We think it is clear that §1391(c) is a general corporation venue

statute, whereas §1400(b) is a special venue statute applicable, specifically, to all defendants in a particular type of actions, i.e., patent infringement actions. In these circumstances the law is settled that ‘[h]owever inclusive may be the general language of a statute, it ‘will not be held to apply to a matter specifically dealt with in another part of the same enactment. * * * Specific terms prevail over the general in the same or another statute which otherwise might be controlling.

Fourco, 353 U.S. at 229.That settled the matter for the next 30-plus years. In 1988, however, Congress amended §1391 to read, “for purposes of venue under this chapter, a defendant that is a corporation shall be deemed to reside in any judicial district in which it is subject to personal jurisdiction at the time the action is commenced” (emphasis added).5

In 1990, in VE Holding, the Federal Circuit addressed this change in the statutory language of the general corporate venue provision. Reasoning that the language “for purposes of venue under this chapter” now constituted “exact and classic language of incorporation”, the court held that Congress now had shown a “clear intention” that 1391(c) supplement (and indeed, provide the definition of corporate “residence” for) 1400(b). VE Holding, 917 F.2d at 1579. The Federal Circuit also noted that “the legislative history of the 1988 amendment reveal[ed] no legislative intent, let alone clearly expressed intent, contrary to the plain meaning of this first sentence of the amended statute”. Id. Thus, under the Federal Circuit’s interpretation of the statutory regime in VE Holding, the general venue provision for corporations applied in patent cases, and corporate defendants were susceptible of suit in any federal district in which personal jurisdiction – a low bar – could be established. And the matter was once again settled for nearly another 30 years. Against the backdrop of VE Holding, the patent litigation landscape changed considerably in the United States between 1990 and 2015. As one indication of this change, the distribution and concentration of patent cases across the United States shifted quite dramatically. More and more cases found their way to particular federal districts, including some districts which – rightly or wrongly – were perceived to be more claimant-friendly. The Eastern District of Texas, as one example, which includes about 1 per cent of the population of the

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According to the Court: “Section 1391(d)8 is not derived from the general venue statutes that §1400(b) was intended to replace. Section 1391(d) reflects, rather, the longstanding rule that suits against alien defendants are outside those statutes.” Accordingly, “we conclude that in §1391(d) Congress was stating a principle of broad and overriding application, and not merely making an adjustment in the general venue statute, as this Court found Congress had done in Stonite and Fourco”. In so finding, the Court relied heavily on In re Hohorst, a case dating from 1893 holding that non-U.S. defendants in general were not subject to the venue statutes all the way back to the Judiciary Act of 1789. Given this reasoning, it seems likely that the rule of Brunette will stay intact, but this creates an odd state of affairs in which one provision of the general venue statute (concerning venue for U.S. corporations) does not apply in patent actions, but a neighbouring provision of the same general statute (concerning non-resident entities) states a rule that applies in all federal civil actions, including patent actions.

Conclusion

The TC Heartland decision likely will have a significant impact on where patent cases against domestic U.S. corporations may be heard. In the wake of this decision, U.S. domestic corporations may only be sued in districts in the state in which they are incorporated, or where alleged infringement has occurred and the corporation has a regular and established place of business. Would-be claimants, therefore, will have limited choice as to where to bring lawsuits, and the opportunities for forum-shopping will be limited. This represents a major departure from the last 27 years of U.S. patent practice.

Endnotes

1. 134 S.Ct. 1514 (2017).2. The current version of 28 U.S.C. 1400(b) provides: “Any

civil action for patent infringement may be brought in the judicial district where the defendant resides, or where the defendant has committed acts of infringement and has a regular and established place of business.”

3. 917 F.2d 1574 (Fed. Cir. 1990).4. Prior to 1897, patent lawsuits were governed by the general

federal venue statutes, beginning with the first venue provision in the Judiciary Act of 1789.

5. Section 1400 is part of the same “chapter” as §1391.6. See Colleen V. Chien and Michael Risch, Recalibrating

Patent Venue, Santa Clara Univ. Legal Studies Research Paper 10-1, October 2016, at pp. 3–4.

7. The Federal Circuit was created in 1982 in part to create uniformity in U.S. patent law. Prior to the creation of the Federal Circuit, patent appeals from district court litigation were heard in the regional circuit courts of appeal, which applied their own circuit precedents in the absence of binding authority from the U.S. Supreme Court.

8. 28 U.S.C. §1391(d), at that time, stated that “(a)n alien may be sued in any district”.

Regular and Established Place of Business

One of the key issues that will be litigated as a result of the Heartland decision is what constitutes a “regular and established place of business”. A key point to note is that much of the case law gloss on this phrase pre-dates the creation of the Federal Circuit.7

The Federal Circuit only had one occasion to weigh in on the meaning of this phrase, and when it did so, it was reviewing for clear error a district court’s decision not to dismiss a case based on improper venue. Because it was a deferential standard of review, the Federal Circuit spent little time addressing the contours of the test for a regular and established place of business. The court did say that “whether the corporate defendant does its business in that district through a permanent and continuous presence there and not…whether it has a fixed physical presence in the sense of a formal office or store”. In re Cordis Corp., 769 F.2d 733, 737 (1985). However, the court did note that the Supreme Court had “yet to address the issue of whether it is necessary to show that a corporate defendant maintains a fixed physical location within a jurisdiction in order to find that it has an established place of business as required by §1400(b)”. 769 F.2d at 736.Amongst the pre-Federal Circuit cases, at least a few principles are clear: it is not sufficient to merely be “doing business” in a district to meet the requirement. There must be some “permanent and continuous” presence there. In the Cordis case, the presence of sales representatives in the district, who held company inventory in stock at their home offices, drove company cars, enlisted the services of a secretarial support firm, instructed surgeons on the proper use of their medical devices during surgical procedures, and deducted the expenses of their home offices was found sufficient to constitute a “regular and established place of business” – or at least not to constitute clear error on the part of the district court.In other cases, circuit courts generally agreed that the presence of an independent distributor or agent, or a temporary presence for the purpose of conducting a sale, is insufficient to meet the requirement. On the other hand, the presence of a full-time sales representative, even working from a home office, may in some cases be sufficient. The courts will be picking up decades-old case law and continuing to develop gloss on the meaning of this statutory language.

Foreign Corporations

The other key issue raised by TC Heartland concerns whether there are restrictions on venue for suits against foreign (i.e., non-U.S.) corporations and similar entities. The Supreme Court expressly noted: The parties dispute the implications of [Heartland’s] argument

for foreign corporations. We do not here address that question nor do we express any opinion on this Court’s holding in Brunette Machine Works, Ltd v. Kockum Industries, Inc., 406 U.S. 706 (1972) (determining proper venue for foreign corporation under then existing statutory regime).

TC Heartland, 137 S.Ct. at 1520, n.2 (emphasis added).In Brunette, the Supreme Court held that foreign corporations could be sued for patent infringement in any federal district. The court stated that “in 1897 Congress placed patent infringement cases in a class by themselves, outside the scope of general venue legislation”. Yet the court concluded that the 1400(b) analysis “shed[] no light on the present case”, in which a Canadian defendant asserted that it was not subject to proper venue in the U.S. District Court for the District of Oregon because it did not have a “regular and established place of business” there. Brunette, 406 U.S. at 713.

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D. Stuart Bartow Lewis Roca Rothgerber Christie LLP4300 Bohannon Drive, Suite 230Menlo Park, California 94025USA

Tel: +1 650 391 1380Email: [email protected]: www.lrrc.com

Terry Ahearn Lewis Roca Rothgerber Christie LLP4300 Bohannon Drive, Suite 230Menlo Park, California 94025USA

Tel: +1 650 391 1380Email: [email protected]: www.lrrc.com

Lewis Roca Rothgerber Christie LLP is a firm of nearly 300 attorneys spanning the fast-growing Western United States. The firm features world-class practices in intellectual property, litigation, gaming, and business transactions, along with broad expertise in government relations and regulatory affairs. Clients turn to the firm for the strength of its experience across various industries, including biotechnology, medical devices, pharmaceuticals, electrical and computer engineering, Internet law, financial institutions, energy infrastructure, and mining, among others.

From its largest offices across California, Arizona, Colorado, and Nevada, the firm offers a full complement of national (and international) intellectual property services, including patent, trademark, trade secret and copyright litigation, patent and trademark prosecution, and opposition practice before the U.S. Patent and Trademark Office. The firm also has a long history of pro bono civic participation, including the successful handling of the landmark Miranda case before the U.S. Supreme Court.

Stuart Bartow is a partner in Lewis Roca Rothgerber Christie’s Intellectual Property practice group, and is co-managing partner of the Silicon Valley office. He represents clients from around the globe in intellectual property matters, with an emphasis on complex patent and trade secret disputes concerning high technology.

Stuart’s primary expertise is in patent litigation in the U.S. federal courts, where he has directed jury trials in multiple districts. He also has experience in appeals before the U.S. Court of Appeals for the Federal Circuit, investigations before the U.S. International Trade Commission, centralisation proceedings before the Judicial Panel on Multidistrict Litigation, and arbitration proceedings before the International Chamber of Commerce. A registered U.S. patent attorney with a background in computer engineering and neuroscience, he also advises on IP portfolio management, practice before the U.S. PTO, and licensing matters and related antitrust concerns for domestic and international clients.

Terry Ahearn is a trial lawyer who represents clients in intellectual property and other complex commercial litigation related to high technology. He also co-manages Lewis Roca Rothgerber Christie’s Silicon Valley office.

Terry has significant experience managing major, complex patent litigations, including pre-litigation investigations, budgeting, managing large-scale discovery, taking and defending depositions, drafting and arguing motions, and managing and participating in all phases of trial, including preparing and presenting opening statements and closing arguments and taking witnesses on direct and cross-examination.

Terry’s trial experience includes multiple trials before the U.S. federal district courts, hearings before the U.S. International Trade Commission, and arbitrations before the International Center for Dispute Resolution, American Arbitration Association and JAMS. He has also appeared in appeals before the U.S. Court of Appeals for the Federal Circuit.

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Chapter 4

1 General Information

The first attempts to set up the Eurasian patent system date back to the early 1990s when the Soviet Union was on the brink of collapse. On 9 September 1994, the Eurasian Patent Convention was officially signed.The Convention is a special agreement within the meaning of Article 19 of the Paris Convention and Article 45(1) of the PCT on regional patents. It establishes the Eurasian Patent Office (EAPO).EAPO is headed by the President. The official language of EAPO is Russian.

2 What is a Eurasian Patent?

Territory

A Eurasian (EA) patent has legal effect in the territory of Russia, Turkmenistan, Belarus, Tajikistan, Kazakhstan, Azerbaijan, Kyrgyzstan and Armenia (“Contracting States”).

Patent terms

The term is 20 years from the date of filing the application. An EA patent can be further extended in the Contracting State, the legislation of which provides for extension of national patents. An EA patent is extended in accordance with the requirements and procedure envisaged by the legislation of this State for extension of a national patent. For example, the term of an EA patent relating to a pharmaceutical, pesticide or agrochemical can be extended in Russia for not more than five years depending on when the first official permission to use this product was granted.

Patentability conditions

EA patents are granted for inventions only. The invention must be novel, inventive and industrially applicable.EA patents cannot be granted for: ■ discoveries; ■ scientific theories and mathematical methods; ■ presentation of information; ■ methods of economic organisation and management;■ symbols, schedules and rules, including rules of games; ■ methods for performing mental acts;

■ algorithms and computer programs; ■ topographies of integrated circuits; ■ projects and plans for structures and buildings and for land

development; ■ solutions concerning solely the outward appearance of

manufactured goods and aimed at satisfying aesthetic requirements;

■ plant varieties and animal breeds; ■ topologies of integrated circuits; and■ inventions, the commercial use of which it is essential

to prevent, for the purposes of protecting public order or morality, including the protection of the life and health of people and animals or the protection of plants, or in order to prevent serious damage being caused to the environment.

Unity of invention

This requirement is similar to that in the PCT. There must be a single inventive concept that is a technical relation between the inventions demonstrated through one or more special technical features.In practice though, there may be difficulty in interpreting the term “special technical features”. Examiners tend to imply by this features of the invention literally as they are mentioned in the claims. Yet, if there are no such “similarly worded” features in claims, it does not necessarily mean that there is not a single inventive concept.

Infringement

To maintain infringement, each feature of the independent claim or, if allowed by the national legislation, the feature equivalent thereto must be used. The doctrine of equivalents can, therefore, be applied to an EA patent in a particular Contracting State insofar as it can be applied to national patents of this State. Yet there is no legal definition of the term “equivalent feature”. In Russia, for example, there are only some general recommendations, and the question of whether the feature is equivalent or not is typically up to the expert preparing an infringement opinion for the court. There is an issue with the subject matter “use” in the EA legislation. “The use” is mentioned among other subject matters that can be protected. Examiners also often suggest changing the preamble of an independent claim to “the use” when they think it better reflects the essence of the invention. Yet, for some reason, what to consider infringement of an EA patent is specified only for “the product” and “the process”. Can “the use” be related to either of these? There has been a lot of controversy about this question in Russia, and now there is a special norm defining infringement of a “use” patent

Maxim Sobolev

Rouse & Co. International (UK) Limited (Moscow Branch)

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Publication

The application is published within 18 months from the filing date or, if it is a PCT application, from the date of entering it into the regional phase. If the PCT application has been published in Russian at the international phase, this publication replaces the “Eurasian” one. The publication date is important because as soon as the application is published, provisional legal protection of the invention begins.The application is normally published together with the search report. If the search report is not ready by the time of publication, it is published separately as soon as ready.The application is not published if it is withdrawn no later than in 16 months from the filing date.

Substantive examination

A request for substantive examination for non-PCT applications must be filed within six months from the publication of the search report. Thus, the applicant has time to analyse the search results and decide if they should request substantive examination. However, the SE request for PCT applications must be filed alongside with entering the application into the regional phase.The requirements for claims are mostly standard. Claims must be clear and supported by the description. A claim must contain a combination of features necessary to achieve the technical result (“essential features of the invention”).Unlike, for example, in Russia, “multiple dependency” (Rule 6.4 of the Regulations under the PCT) is allowed, which is certainly an advantage as there is no need to amend the claims.During substantive examination the invention is examined, in particular, for its compliance with requirements for claims, patentability conditions and the unity requirement.It is possible to amend the description and claims without modifying the essence of the invention until a decision to grant a patent or a decision on refusal is issued. New features are considered as modifying the essence of the invention if they were not present in the original application materials on the filing date. The problem with introducing amendments is that recently examiners have not been distinguishing between amendments made on the applicant’s initiative and those made on the examiner’s initiative. Consequently, the examiner is supposed to request payment of the fee for amendments even if these amendments were only made to obviate the examiner’s objections. However, it is obvious that introduction of such amendments must be viewed as part of substantive examination, a fee for which has already been paid. Also, examiners practically always suggest amending claims, and the fees for amendments may be tangible. The EA legislation appears to need some improvement in this respect.

Grant of patent

An EA patent is granted after paying a grant fee within four months from the receipt of notification on readiness to grant the patent.

Refusal to grant patent

A refusal may be issued if:■ The invention does not correspond to patentability conditions. ■ The applicant refuses to amend claims as required.

separately from “the product” and “the process”. As for Eurasian patents, courts seem to have no other choice but to relate “the use” to either “the product” or “the process” depending on the situation. There have been no legal cases yet that would shed light on this issue, and the problem remains. Like in many countries, the Eurasian legislation also provides for indirect protection of the product obtained by the patented process, the right of the prior user (before the priority date) and the right of the subsequent user (from the date on which the right to the application or patent lapsed to the date of publication of the information on the restoration).There are acts which are not considered infringement; specifically: ■ use in the construction or operation of means of transportation

of a member State of the Paris Union for the Protection of Industrial Property that is not a Contracting State, when such means of transportation temporarily or accidentally enters the territory of the Contracting State, provided that the invention is used exclusively for the needs of said means of transportation;

■ use for scientific research and experimental purposes; ■ use for the occasional preparation, in a pharmacy, of a

medicine on a medical prescription;■ use for private non-profit-making purposes; and■ use of a product after this product has been marketed by the

patent owner himself or with his consent in a Contracting State where the Eurasian patent is valid and in which the product in question was marketed.

Provisional legal protection of the invention starts from the date of publication of the application in Russian.

3 How to Obtain a Eurasian Patent

Representation

Applicants from the countries other than Contracting States must be represented by an EA patent attorney. Typically, EAPO does not require for the EA patent attorney to submit the Power of Attorney. However, there are certain cases when it is mandatory; for example, if the applicant wishes to withdraw the application or assign the rights. Importantly, the Power of Attorney is also required when a new representative is appointed.

Filing application

An EA application must contain a request, a description, claims, drawings or other materials if they are necessary for understanding the essence of the invention. A filing fee must also be paid.

Formal examination

During formal examination, the application is checked for compliance with formal requirements. The priority of the application is checked as well.

Patent search

A search report is sent to the applicant as soon as it is ready, separate from substantive examination.

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Invalidation in a Contracting State

A Eurasian patent can be invalidated fully or partially in the territory of each Contracting State during the whole term of the patent. Invalidation is possible if:■ the invention does not comply with patentability conditions;■ there are features in claims that were not in the original

application materials;■ the application materials do not disclose the invention clearly

and fully enough to be realised by a skilled person; and■ there is incorrect indication of the applicant or the inventor.Thus, the conditions for invalidation are the same as for administrative invalidation with one additional ground.The procedure of invalidation is brought about in accordance with procedural norms of the Contracting State.

5 Choosing a Eurasian or Russian Patent

If the applicant is interested in obtaining protection in all Contracting States at once, one EA patent will be certainly preferable over several national applications. However, if the applicant is mainly interested in Russia (with only peripheral interest in some of the other countries), then the question may arise of which application is better to file: Russian or Eurasian.In terms of the protection that Russian and Eurasian patents provide, there are some differences; however, basic principles may be said to be similar. The fees (and ongoing annuities) for obtaining a Eurasian patent are higher than for a Russian patent, as would be expected, given the protection in eight jurisdictions. Examination by the Eurasian Patent Office and enforcement procedures in a number of the Contracting States generally appear to be poorer than in Russia. Accordingly, the incremental protection in a number of the States may be limited in practical terms. These are probably three main things to take account of when deciding between Russian and Eurasian patents. In some cases, it may be worth expending the additional fees to follow the Eurasian patent route; in others it is unjustified. The choice remains the applicant’s.

■ The claims do not correspond to the other application materials.

■ The application materials do not disclose the invention clearly and fully enough to be realised by a skilled person.

An appeal from the refusal can be filed within three months from the date of receipt of the notification on refusal. The appeal is considered within four months by the Board of examiners, at least two of whom have not been in charge of the refusal. The decision of the Board can be further opposed by filing an appeal to the President of EAPO within four months from sending the decision to the applicant. The President’s decision is final.

Conversion of application

An EA application can be converted into a national one, which is a useful option. For example, if an EA application was rejected because the invention did not involve an inventive step, it might make sense to convert it into a Russian application, as, unlike EA legislation, the Russian legislation provides for protection of utility models, which do not have to involve an inventive step.

4 How to Invalidate a Eurasian Patent

Administrative invalidation/opposition

To invalidate an EA patent fully or partially in the territory of all Contracting States at once (“administrative invalidation”), an opposition must be filed with EAPO within six months from the publication of the patent. Invalidation is possible if:■ the invention does not comply with patentability conditions;■ there are features in claims that were not in the original

application materials; and■ the application materials do not disclose the invention clearly

and fully enough to be realised by the skilled person.A decision taken during administrative invalidation can be opposed by filing an appeal to the President within four months from the date of sending the decision.

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Maxim SobolevRouse & Co. International (UK) Limited (Moscow Branch)Office 410, 4th Floor Business CentreDucat Place II, 7 Gasheka StreetMoscow 123056Russia

Tel: +7 495 230 03 37Email: [email protected]: www.rouse.com

Rouse is a global IP leader specialising in the creation, management, commercialisation and enforcement of IP rights. Established in the United Kingdom in 1990, we now have 17 offices in Africa, Asia, Europe and the Middle East, as well as an associated office in Saudi Arabia. In October 2015, we launched an office in South Africa, making us the first global IP firm to launch in sub-Saharan Africa.

Having opened in 2013, our Moscow office is a recent addition to Rouse’s global business. This was in response to frequent requests from our clients to assist them in this region. From there we handle IP work throughout Russia as well as the Commonwealth of Independent States. Our clients include major multinational blue-chip companies in the energy, manufacturing, automotive, pharmaceutical, technology and household and luxury goods sectors.

Significant clients of the firm’s Moscow office include: LPG Systems; KSR KUEBLER; Niveau-Messtechnik AG; Sony-Mobile; Procter & Gamble; Reckitt Benckiser; Richemont; Bourjois; Harley-Davidson; Nintendo; and DuPont.

Maxim Sobolev is a Russian Patent and Trademark Attorney and a Eurasian Patent Attorney in the Moscow office of Rouse. Maxim specialises in drafting, filing and prosecuting patent applications for inventions and utility models. He has worked with patents since 2000. Prior to joining Rouse, Maxim worked at another international law firm as a Patent Attorney. He has also worked as a Patent Examiner at the Russian Patent and Trademark Office (Rospatent), and was Head of Patents at one of the leading Russian pharmaceutical companies and at a Russian IP law firm. Maxim has extensive experience in drafting patent applications, filing PCT applications at the Russian national and Eurasian regional phases, advising clients on Office actions, preparing responses thereto, filing oppositions and preparing non-infringement/freedom-to-operate opinions.

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Chapter 5

Rouse & Co. International/Kadasa & Partners

Gulf Co-operation Council Countries – Patent Landscape

Table 1: Patents in GCC: Routes to Protection

Country National Patent Paris Convention PCT

Bahrain Yes Yes Yes

Kuwait

As of April 2016, the Kuwaiti Patent Office ceased to accept new patent applications and requested the applicants to file their patent applications in the GCC Patent Office

As of April 2016, the Kuwaiti Patent Office ceased to accept new applications and requested applicants to file patent applications in the GCC Patent Office

Yes

Oman Yes Yes YesQatar Yes Yes YesSaudi Arabia Yes Yes Yes

UAE Yes Yes Yes

GCC Patent Office

Yes – direct filing is possible

No, but 12 months’ priority is recognised

No

iii) Translation The language for filing and prosecution in all countries in

the GCC is Arabic. Translation can pose challenges and it is strongly recommended that at least the claims are reviewed by an experienced patent practitioner with fluency in the language to minimise issues with enforcing a patent in the future.

iv) Professional Practice The patent agent/attorney profession is not regulated by a

professional body in the GCC. Whilst individual national patent offices will grant licences to firms to act before them, there is no requirement to have a separate qualification of being a ‘patent attorney’. This has resulted in some difficulties for applicants who have instructed firms with poor understanding of patent law and practice. To date, the UAE Patent Office has been sympathetic to applicants where their rights have been significantly prejudiced through agent errors. However, there is no guarantee that they will continue to exercise their discretion in this manner.

The lack of a robust professional regulating body in the region does hamper the development of patent practice.

1 Introduction

The Gulf Co-operation Council (‘GCC’) is made up of Bahrain, Kuwait, Oman, Qatar, Saudi Arabia, and the United Arab Emirates. The GCC states co-operate on many economic, legislative and security matters. The goal is to achieve a common market and monetary union.

2 Patents within the GCC

i) GCC Patent Regulation In 1992, the GCC approved a patent regulation that

established a unitary patent right covering all GCC countries. The GCC Patent Office was established in 1992 in Riyadh, Saudi Arabia and started accepting applications in 1998. The GCC Patent regulations were amended in 2000, notably adding in a novelty requirement for patentability.

The law is broadly TRIPs compliant. One feature that can be seen as unique is the requirement that, in addition to the normal requirements of novelty, inventive step and industrial applicability, inventions must also not be in conflict with Shari’ah law.

The decision of the GCC Patent Office to grant a GCC patent is published in the GCC patent gazette. Any interested person may file before the GCC Patent Grievances Committee an action for invalidation within three months of such publication. There are at least four decisions of the Patent Grievances Committee in which it decided that it has no jurisdiction to review any action of invalidation of a GCC patent after three months from the date of publication of the decision of grant in the patent gazette. Under a proposed amendment to the Saudi Patent Law, the Saudi Patent Disputes Committee would be abolished and jurisdiction to hear patent-related proceedings in the first instance will shift, likely to the Courts. It remains to be seen, if this amendment is passed, what impact this will have on the GCC patent legislation and procedure.

The decisions of GCC Patent Grievances Committee are subject to appeal before the competent authority in the hosting state, Saudi Arabia. Therefore, appeals are filed to the Administrative Court in Riyadh.

ii) Protection Routes in GCC Table 1 summarises the routes an applicant may take to

secure patent protection within the GCC block of countries.

Sara Holder

Mohammad Jomoa

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B. Invalidity is an acceptable defence to such an infringement action.

Therefore, if the infringement proceedings are commenced in another GCC country, the Court may use its discretion to stay the infringement proceedings pending the outcome of the revocation proceedings. The potential delay that this may cause in having infringement issues considered, in a region where interim injunctions are difficult to obtain, is potentially frustrating to patentees.

With respect to UAE national patents, the infringement proceedings should be filed in the Emirate where the infringement is occurring. Again, there is potential for conflict of jurisdiction between Emirate-level courts hearing infringement cases, and Federal Courts who would have jurisdiction over any corresponding revocation proceedings.

d) Emerging Jurisprudence in Saudi Arabia As noted above, of the GCC countries, Saudi Arabia has seen

perhaps the most patent-related litigation. Most of the patent litigation cases are related to either the pharmaceutical area or petrochemical area.

No plaintiff, to our knowledge, has ever been awarded damages in a patent infringement lawsuit in Saudi Arabia. The Court may resort to a variety of methods in calculating patent damages, including lost profits and reasonable royalties. However, because Shari’ah law requires a very strong causal relationship between cause and effect in damage calculations, damages are very difficult to prove and even in the event of successful patent litigation, such damage awards are likely to be quite small.

Injunctions are statutorily available under Saudi Law; however, no court or administrative body in Saudi Arabia has ever granted a Plaintiff’s request for an injunction.

The proposed changes to Saudi Arabia’s Patent Law outlined above, may reduce the efficacy of litigation in relation to patents in the short term.

The GCC patent system is relatively new and evolving. There are few precedent cases.

4 Proposals for Amendment of GCC Patent Law

According to the General Director of the GCC Patent Office, it is necessary to:■ update the law generally as it is the oldest in comparison to

the national patent laws of the Council States;■ provide protection for Utility Models;■ ensure compliance with some of the provisions of the

international agreements of PLT and PCT – this may be more likely since Kuwait has now acceded to the PCT;

■ benefit from the developmental aspects provided by the TRIPS Agreement as affirmed by Doha Declaration on the TRIPS Agreement and public health; and

■ tackle aspects not contained in the current law (publication of applications, invalidation, national treatment and the like).

5 Technology Development in the GCC

Many of the GCC governments are now expressly emphasising and putting in place programmes to encourage the development of technology-based economies. Part of this drive comes from the desire to move away from traditional economic reliance on oil and gas. Saudi Arabia, the United Arab Emirates and Qatar are three of the most active in this drive for technological innovation and Qatar has embarked upon a recent legislative agenda to strengthen

3 Revocation and Infringement

a) General Litigation in relation to patents has been relatively limited.

This is due to a number of factors:■ Patent systems are relatively new to the region and only

small numbers have been granted as yet. ■ It is difficult to obtain information and therefore difficult

to understand how the judiciary are treating general principles of patent law – Court decisions are rarely published, and when they are, only the highest level decisions are published.

■ There is a lack of specialist judges and experts in the region to hear such cases. In 2017, we reported two developments in this area. The Federal Court of the UAE established a new specialist IP division to hear IP related cases. The judges in this division were to receive additional training on IP rights and law. This division has commenced hearing cases and is moving cases very quickly. Much of the process is conducted with the Case Management Office and only once the parties have completed all their submissions of arguments and evidence does the matter go before a judge. Contrary to this was a potential step backwards in Saudi Arabia, where proposed amendments to the Patent Law would disband the specialist Patent Committee in favour of cases being sent to the criminal division of the Board of Grievances (despite being civil cases). This amendment has yet to be passed as of the time of writing.

There continues to be some reluctance in industry to access the patent systems in the region, believing that the costs of securing a patent will not result in an easily enforceable right. This has been reinforced by a recent decision of a court in the UAE to refuse to enforce a GCC patent on the grounds that the necessary regulations to do so had not been issued locally.

Saudi Arabia has seen the most patent litigation, having the longest established patent system and being the largest market in the GCC. In addition, it deals with revocation of GCC patents.

b) Revocation Revocation of a GCC patent is a complicated issue. This is

due to the fact that it is not an easy task to determine the exact forum before which the action has to be filed. The difficulty is attributed to the following facts:(1) there is an apparent gap in the GCC Patent Law in

relation to the issue of invalidation of a GCC patent;(2) the jurisdiction of the Patent Committee is limited to

review of the decisions of the GCC Patent Office within three months from the date of notification or publication of relevant decision; and

(3) the issue of enforceability of the GCC patents is left to each state independently.

c) Infringement Infringement proceedings may only be commenced after the

grant of a patent and should be commenced in the country where the infringement occurs.

With respect to GCC patents, if a defence of invalidity is claimed, then the revocation proceedings should be brought in Saudi Arabia. Invalidity of a GCC patent as a defence against infringement action is legally justifiable and acceptable, because the Saudi Patent Committee has statutory jurisdiction to review the action of infringement of a GCC patent. This is supported by case law: Decision of Committee No. 52/1432 H. Lundbeck AS v. SPIMACO. The decision stated:A. The Saudi Patent Committee has jurisdiction to enforce

GCC patents in Saudi Arabia and the legal means of enforcement is the action of infringement.

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These initiatives have had varying degrees of success and many are starting to gain traction now. However, it is clear that many businesses that would consider investing are still wary of weaknesses in the patent (and IP) systems in the region – prosecution delays, prosecution expense (particularly the need for Arabic translations and notarisation and legalisation of documents), lack of specialist courts, judges and experts, and protection of trade secrets and confidential information. For the GCC countries to truly benefit from investment in turning their economies into being technology-based, these issues will need to continue to be addressed.

its IP regime in approving new laws on designs and in relation to copyright. Approaches have included funding for university research, encouraging private sector funding of research, subsidising the filing of patent applications, and establishment of technology-targeted free zones. Some examples of free zones that have been established to target particular technology based and innovative industries include:■ Masdar City – a carbon neutral city focused on renewable and

alternative energy sources.■ Dubai Science Park.■ Dubai Silicon Oasis – IT-related componentry and

technologies.

Rouse & Co. International/Kadasa & Partners Gulf Co-operation

Sara HolderRouse & Co. International11th Floor Maze TowerSheikh Zayed Road, PO Box 31778DubaiUAE

Tel: +971 4 309 8000Fax: +971 4 309 8001Email: [email protected]: www.rouse.com

Mohammad JomoaKadasa & PartnersKadasa Building, Ibn Katheer Street King Abdulaziz Street, PO Box 20883 Riyadh 11465 Saudi Arabia

Tel: +966 11 478 6315Fax: +966 11 476 1044Email: [email protected]: www.kadasa.com.sa

Established in 1990, Rouse is an intellectual property (IP) law firm and consultancy, with offices in 13 countries. We provide the full range of IP services required by our clients to develop, implement and continually revise an IP strategy, from the implementation of global enforcement strategies, to the provision of commercial IP services, and IP acquisition and maintenance services. We currently represent approximately 1,400 clients managing work in over 180 countries. Long-standing clients include many of the world’s foremost IP owners.

In Saudi Arabia, Rouse works in association with Kadasa & Partners. Kadasa & Partners was founded 30 years ago by the renowned Saudi attorney Nassir Ali Kadasa in Riyadh, under Associated Patent Attorneys (APA). Mr. Kadasa has the distinction of being the first Saudi attorney to prosecute and win an infringement lawsuit on behalf of a foreign entity against a national infringer. The mainstay of the firm is the qualified and experienced 50+ staff members. Our staff have skillfully navigated through all IP matters in Saudi Arabia.

Sara Holder currently heads up the MEA practice of global IP firm, Rouse. She holds degrees in law and science (Biochemistry) and qualified and practised in New Zealand as a lawyer before joining Rouse in 1998. Since then, she has worked in China, Indonesia and the Middle East, becoming a specialist in the issues and challenges faced by, and encountered in, developing intellectual property jurisdictions.

In addition to her academic qualifications and experience, Sara is a member of various IP organisations, has published numerous articles in industry journals, contributed to various texts on intellectual property and speaks regularly at seminars and conferences. She is regularly ranked as a leader in her field.

Mohammad Jomoa is the Intellectual Property Manager at Kadasa & Partners, specialising in pharmaceutical and petrochemical patent litigation.

He holds a Postgraduate Diploma in Intellectual Property Laws (FPLC (USA) and International Law Institute (Gulf)), and a Bachelor of Science in Chemical Engineering (University of Toledo, Ohio, USA). Mohammad has over 28 years of experience in IP matters in Saudi Arabia and in the Gulf Cooperation Council (GCC) states. He has supervised advanced and graduate studies programmes in IP in cooperation with international organisations and renowned universities. Expertise includes Patent and designs prosecution, litigation, and freedom to operate opinions under GCC and Saudi Patent Law. As an external counsel for many Pharma companies, he extensively worked on Data Protection, Patent Linkage and Pharmaceutical laws. Mr. Jomoa is a regular speaker on IP issues in the gulf region, He advises Kadasa clients on techno-legal issues in the Middle East region and regularly advises Saudi Government offices on IP legislation.

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Chapter 6

Bird & Bird LLP

Australia

start a proceeding, can seek an order for “preliminary discovery” of documents by that party. After commencementThe FCRs also provides mechanisms to obtain “standard” and “non-standard” discovery of documents after the commencement of a proceeding. Orders for discovery after commencement are not made as a matter of course and a party must only seek discovery (whether “standard” or “non-standard”) if it will facilitate the just resolution of the proceeding as quickly, inexpensively and efficiently as possible. Other mechanismsA party to a proceeding can use Notices to Produce served on a party requiring the party to produce any document or thing within the party’s control at the trial.

1.4 What are the steps each party must take pre-trial? Is any technical evidence produced, and if so, how?

There are numerous steps a party must take in the lead up to the trial. A new practice note in the Federal Court, IP1, provides some examples of special steps which may be ordered to be undertaken in patent matters (e.g. the court may also order that the parties file a technical primer to assist the court).The first step is the pleading of each party’s case (a statement of claim, a defence and any cross-claim, defence to cross-claim and replies).After the close of pleadings, evidence will be led by both parties. Evidence relied on for both infringement and revocation will invariably include expert technical evidence. In the immediate lead up to the trial, a case management conference will occur before the judge. At the case management conference, the judge will set a timetable for the filing of submissions, court book preparation and other requirements the judge may have in preparation for the trial. This may also include orders regarding evidence to be taken concurrently and a timetable for competing experts to confer prior to the trial and the taking of the concurrent evidence.

1.5 How are arguments and evidence presented at the trial? Can a party change its pleaded arguments before and/or at trial?

At the trial, any affidavit evidence upon which a party intends to rely will be formally “read” by the party relying on the evidence and admitted into evidence. A person that has given evidence in

1 Patent Enforcement

1.1 Before what tribunals can a patent be enforced against an infringer? Is there a choice between tribunals and what would influence a claimant’s choice?

The Federal Court of Australia (Federal Court) and the state and territory Supreme Courts have jurisdiction to hear patent infringement matters. Infringement proceedings are typically brought in the Federal Court because this Court has numerous judges with extensive patent expertise who are appointed to the patent list and allocated to hear these matters.

1.2 What has to be done to commence proceedings, what court fees have to be paid and how long does it generally take for proceedings to reach trial from commencement?

To commence proceedings in the Federal Court, a party must file an originating application, statement of claim, and genuine steps statement in accordance with the Federal Court Rules 2011 (Cth) (FCRs). The fees to file an originating application are prescribed in schedule 1 of the Federal Court and Federal Circuit Court Regulation 2012. As at June 2017, the fee for filing an originating application for a corporation is AUD 3,745.The period of time that elapses between the filing of the originating application and the final trial depends on the complexity of the proceedings – for example, whether the applicant seeks to amend the patent(s), the number of patents asserted, whether experiments need to be carried out, how long evidence preparation takes. Generally, parties should allow anywhere between 12 and 18 months before the final trial on infringement.

1.3 Can a party be compelled to disclose relevant documents or materials to its adversary either before or after commencing proceedings, and if so, how?

The FCRs provide several mechanisms for disclosure of documents both before and after the commencement of proceedings.Before commencementA party that believes they have the right to obtain relief against a party, but does not have sufficient information to decide whether to

Jane Owen

Rebecca Currey

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The person cannot apply to the Federal Court for a declaration unless the patentee has refused or failed to make a written admission of non-infringement.The person must have given the patentee full written particulars of the act, and asked the patentee in writing for a written admission that the doing of the act does not or would not infringe the patent. The person must also undertake to pay the patentee’s reasonable costs of obtaining advice as to whether the act has or would infringe the claim. The patentee must be joined as a respondent in the proceeding.

1.10 If declarations are available, can they address (i) non-infringement, and/or (ii) claim coverage over a technical standard or hypothetical activity?

Non-infringement declarations can be sought in relation to technical standards and hypothetical activity.

1.11 Can a party be liable for infringement as a secondary (as opposed to primary) infringer? Can a party infringe by supplying part of, but not all of, the infringing product or process?

A party can be liable for “indirect” or “contributory” infringement of a patent in Australia. The Patents Act (section 117) provides that if the use of the product by a person would infringe a patent, then the supply of that product by one person to another is an infringement of the patent by the supplier, unless the supplier is the patentee or licensee.

1.12 Can a party be liable for infringement of a process patent by importing the product when the process is carried on outside the jurisdiction?

A person can be liable for infringement of a process patent by importing a product into Australia made by the process outside the jurisdiction. In Apotex Pty Ltd v Warner-Lambert Company LLC (No 2) [2016] FCA 1238, the Federal Court found that the importation and sale in Australia of a product that was made overseas using a method or process the subject of an Australian patent infringed claims of the Australian patent because the acts of importation and sale occur within Australia.

1.13 Does the scope of protection of a patent claim extend to non-literal equivalents?

Australia has no doctrine of non-literal or mechanical equivalents.

1.14 Can a defence of patent invalidity be raised, and if so, how? Are there restrictions on such a defence e.g. where there is a pending opposition?

A respondent can assert in the infringement proceedings in response to any allegation of patent infringement that it has not infringed the patent because the patent is invalid and should be revoked. In this regard, in any proceedings for infringement, the alleged infringer can counter-claim for revocation of the patent, including on the basis that the patent is not a patentable invention.

affidavit form may also be called to be cross-examined by the other party on that evidence.The parties’ arguments are submitted by both written and oral submissions.In terms of seeking amendments to a pleaded case, the court is generally receptive to applications for amendment. The FCRs provide:■ a party must seek leave from the Court to amend its originating

application both before and at trial; and■ a party may amend a pleading once without leave of the Court

at any time before pleadings close. After pleadings close (and including during the trial), any amendment is only by leave of the Court or with the consent of the opposing party.

1.6 How long does the trial generally last and how long is it before a judgment is made available?

The length of a trial will depend on the complexity of the issues before the Court. On average, trials concerning one patent can run anywhere between five and 15 days. Judgment can be anticipated some three to six months after the end of the trial.

1.7 Are judgments made available to the public? If not as a matter of course, can third parties request copies of the judgment?

Judgments are publicly available in Australia, typically within 24 hours of being handed down by the judge.

1.8 Are there specialist judges or hearing officers, and if so, do they have a technical background?

There are presently 17 judges in the Federal Court’s Intellectual Property National Practice Area – Patents & Associated Statutes that can be assigned to patent cases.There is no requirement that these judges have a technical background, though some of them do.

1.9 What interest must a party have to bring (i) infringement, (ii) revocation, and (iii) declaratory proceedings?

InfringementThe patentee and the exclusive licensee can bring infringement proceedings.The exclusive licensee is defined in the Patents Act 1990 (Cth) as the licensee that has the right to exploit the patented invention throughout the patent area to the exclusion of the patentee and all other persons.RevocationAny person has standing to bring an application to either the Federal Court or state and territory Courts for an order revoking the patent. A defendant in any infringement proceedings may also cross-claim for revocation.Declaratory proceedingsA person can apply to the Federal Court for a declaration that an act does not or would not infringe a patent, whether or not the patentee has made an assertion that the doing of the act would infringe a claim.

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undertaking as to damages”, to compensate the restrained party if the patentee does not ultimately win.If the person in whose favour the preliminary injunction is granted is resident overseas and has no assets in Australia, or is otherwise unlikely to be able to satisfy a call on the undertaking as to damages, the Court may require that person to provide security for the undertaking as to damages.Final injunctionsRelief that a court may grant for infringement of a patent includes an injunction, subject to such terms that the court thinks fit.

1.19 On what basis are damages or an account of profits assessed?

Damages are compensatory in nature and so the assessment is made on the basis of the actual loss suffered by the patentee. The analysis will require the Court to determine what proportion of the infringer’s sales would have been sales of the patentee or the exclusive licensee and then determine the profit that would have been made by reason of the sales.Additional (punitive) damages can be awarded, but this provision has only been applied once in Australia and resulted in an award of a modest sum.An award of additional damages may be appropriate having regard to:■ the flagrancy of the infringement; ■ the need to deter similar infringements;■ the conduct of the infringing party, including after it was

informed that it had allegedly infringed;■ any benefit accrued to the infringer because of the

infringement; and■ any other relevant matters.Profits are assessed by calculation of the profit earned by the infringer by reason of the conduct. This is a forensic accounting exercise.

1.20 How are orders of the court enforced (whether they be for an injunction, an award of damages or for any other relief)?

A breach of injunctive orders is enforced by an application for contempt of court (which can result in fines being levied or imprisonment).Enforcement of a judgment debt for payment of compensation is enforced by way of usual methods of execution of judgment – seizure of assets, winding up of a company or bankruptcy of an individual.

1.21 What other form of relief can be obtained for patent infringement? Would the tribunal consider granting cross-border relief?

Other relief which a court may grant for infringement of a patent includes declarations of infringement. Cross-border relief will not be ordered.

1.22 How common is settlement of infringement proceedings prior to trial?

Settlement pre trial is common – estimated to occur in 50% of cases.

1.15 Other than lack of novelty and inventive step, what are the grounds for invalidity of a patent?

In the Federal Court, other than lack of novelty and inventive step, the validity of a patent may be challenged on the grounds that:■ the patentee is not entitled to the patent;■ it is not a manner of manufacture;■ it is not useful;■ the patent was obtained by fraud, false suggestion or

misrepresentation; and■ the specification does not comply with section 40(2) and (3)

of the Patents Act 1990 (Cth), being best method and clarity requirements.

1.16 Are infringement proceedings stayed pending resolution of validity in another court or the Patent Office?

The Court proceedings are the superior proceedings and so no procedure can take place in the Patent Office if there are pending court proceedings.If two separate proceedings concerning the patent were on foot, a party may seek to have the matters listed together but there is no rule that a revocation claim be determined before a parallel infringement proceeding.

1.17 What other grounds of defence can be raised in addition to non-infringement or invalidity?

Australian patent law includes these specific exemptions to infringement:■ immediately before the priority date of the claim, the

person was already exploiting, or had taken definitive steps (contractually or otherwise) to exploit the product, method or process in Australia;

■ use of a patented invention occurred on board or in a foreign vessel, and the vessel came into Australian territory only temporarily or accidentally;

■ use of a patented invention occurred in the construction or working of a foreign aircraft or land vehicle if the aircraft or land vehicle into Australian territory only temporarily or accidentally;

■ exploitation was connected with obtaining regulatory approval in Australia; and

■ an act was done for experimental purposes relating to the subject matter of the invention.

1.18 Are (i) preliminary, and (ii) final injunctions available, and if so, on what basis in each case? Is there a requirement for a bond?

Preliminary injunctionsThe Federal Court will grant a preliminary injunction against an alleged infringer in circumstances where it is satisfied that:■ the patentee has a prima facie case (that there is a probability

that the patentee will succeed at final trial); and■ the balance of convenience favours the granting of the

injunction (this involves the consideration of factors such as whether the payment of damages will adequately compensate the patentee if there is a finding of infringement).

There is no requirement for a bond. Rather, before the Federal Court will make this order, the patentee will have to give the “usual

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If the application to amend is made to the Court during proceedings, then the Court must also be satisfied that there is no matter that should dissuade the Court from exercising its discretion to allow the amendment (e.g. delay by the patentee in seeking amendment after knowing that it should so amend; covetous claiming).

3 Licensing

3.1 Are there any laws which limit the terms upon which parties may agree a patent licence?

Pursuant to section 144, a term of a patent licence may be void in certain circumstances, including where the effect of the term is to:■ prohibit or restrict the use of a product or process (whether

patented or not) supplied or owned by a person other than the lessor or licensor; or

■ require the acquisition of a product not protected by the patent by the lessor or licensor.

3.2 Can a patent be the subject of a compulsory licence, and if so, how are the terms settled and how common is this type of licence?

After a period of three years from grant has elapsed, a person may apply to the Federal Court for an order requiring the patentee to grant the applicant a licence to work the patented invention (section 133). If the fee is not agreed, the court sets the fee. Very few, if any, compulsory licences have been ordered.

4 Patent Term Extension

4.1 Can the term of a patent be extended, and if so, (i) on what grounds, and (ii) for how long?

The term of a patent relating to pharmaceutical substances can be extended if regulatory approval was not obtained until at least five years after the date of the patent. The extension period is the difference of the time period from the filing date of the patent to the first regulatory approval date less five years.

5 Patent Prosecution and Opposition

5.1 Are all types of subject matter patentable, and if not, what types are excluded?

Human beings and processes for their biological generation are not patentable (section 18(3)). Pure business processes are not patentable subject matter, even if computer-implemented (Commissioner of Patents v RPL Central Pty Ltd [2015] FCAFC 177).

5.2 Is there a duty to the Patent Office to disclose prejudicial prior disclosures or documents? If so, what are the consequences of failure to comply with the duty?

There is no such duty.

1.23 After what period is a claim for patent infringement time-barred?

Infringement proceedings cannot be brought unless started within:(a) three years from the day on which the relevant patent is

granted; or(b) six years from the day on which the infringing act was done.

1.24 Is there a right of appeal from a first instance judgment, and if so, is it a right to contest all aspects of the judgment?

A party can appeal judgment of a single judge of the Federal Court to the Full Federal Court of Australia. Appeal is as of right in respect of any aspects of the judgment but will only succeed if the appeal court finds that the judge at first instance made an error of law.

1.25 What are the typical costs of proceedings to first instance judgment on (i) infringement, and (ii) validity? How much of such costs are recoverable from the losing party?

The range of expected costs in running/defending an infringement case or running/defending a combined infringement and revocation case ranges between AUD 500,000 and AUD 1.5 million. The successful party would anticipate recovering between 70% and 75% of its costs from the unsuccessful party.

1.26 For jurisdictions within the European Union: What steps are being taken in your jurisdiction towards ratifying the Agreement on a Unified Patent Court, implementing the Unitary Patent Regulation (EU Regulation No. 1257/2012) and preparing for the unitary patent package? For jurisdictions outside of the European Union: Are there any mutual recognition of judgments arrangements relating to patents, whether formal or informal, that apply in your jurisdiction?

This is not applicable in Australia.

2 Patent Amendment

2.1 Can a patent be amended ex parte after grant, and if so, how?

A patentee may seek the leave of the Commissioner of Patents to amend a patent after grant (section 104).

2.2 Can a patent be amended in inter partes revocation/invalidity proceedings?

A patentee may make an application to a court during any relevant proceedings for an order that the patent be amended (section 105).

2.3 Are there any constraints upon the amendments that may be made?

An amendment must meet the requirements in section 102 – an amendment is not allowable if the amended specification claims or discloses matter extending beyond the complete specification as filed.

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for the imposing, or giving effect to, a condition of a licence granted by the owner or licensee of a patent, registered design, copyright, or circuit layout right or by an applicant for registration of a patent or design; or an assignment of any of these rights.If the licence is outside section 51(3), then these provisions may give rise to a contravention of the CCA:(a) the prohibition on the making or giving effect to agreements,

arrangements or understandings that have the purpose, effect or likely effect of substantially lessening competition in a market (section 45 of the CCA);

(b) the prohibition on exclusive dealing in section 47 of the CCA; and

(c) the prohibition on the making and giving effect to provisions of agreements between competitors by which one or more is restricted, prevented or limited from supplying goods or services to, or acquiring goods or services from particular persons or classes of person (a primary boycott) which is also prohibited (sections 4D and 45 of the CCA).

8 Current Developments

8.1 What have been the significant developments in relation to patents in the last year?

There have been some significant findings in cases in the last year:■ the decision that taking steps to have a pharmaceutical

product listed on the Pharmaceutical Benefits Scheme (PBS) is not patent infringement – Warner-Lambert Company LLC v Apotex Pty Limited [2017] FCAFC 58;

■ the decision that importation of a product made by a patented process overseas is an infringement – Apotex Pty Ltd v Warner-Lambert Company LLC (No 2) [2016] FCA 1238; and

■ the expression by the Court that novelty cannot be conferred in drafting a patent claim by addition of mere new information so as to distinguish a claim for prior art – Otsuka Pharmaceutical Co., Ltd v Generic Health Pty Ltd (No 2) [2016] FCAFC 111.

8.2 Are there any significant developments expected in the next year?

On 20 December 2016, the Australian Productivity Commission released its report on its Inquiry into Intellectual Property Arrangements in Australia. The report recommended that “Commercial transactions involving IP rights should be subject to competition law. The current exemption under the CCA is based on outdated views and should be repealed”. At the time of writing, draft legislation to amend the CCA has not included repealing section 51(3) of the CCA and, accordingly, it remains to be seen whether this important recommendation will be implemented.

8.3 Are there any general practice or enforcement trends that have become apparent in your jurisdiction over the last year or so?

Yes – there is the new Intellectual Property Practice Note (IP-1) in the Federal Court which applies to patent litigation.

5.3 May the grant of a patent by the Patent Office be opposed by a third party, and if so, when can this be done?

The grant of a patent may be opposed by a third party within three months after the patent application has been advertised as accepted.

5.4 Is there a right of appeal from a decision of the Patent Office, and if so, to whom?

There is a right of appeal from a decision of the Patent Office to the Federal Court, from a refusal to grant a patent (section 100A), an opposition decision (section 60), a decision to revoke after re-examination (section 101), refusal or grant of, or direction to make an amendment (sections 104 and 109).

5.5 How are disputes over entitlement to priority and ownership of the invention resolved?

Disputes over ownership can be resolved in the Patents Office (section 32), or by the grant of the patent after an opposition in the Patents Office (section 33) or by application to the Court.

5.6 Is there a “grace period” in your jurisdiction, and if so, how long is it?

There is a grace period of 12 months.

5.7 What is the term of a patent?

A standard patent has a maximum term of 20 years and an innovation patent has a term of up to eight years.

6 Border Control Measures

6.1 Is there any mechanism for seizing or preventing the importation of infringing products, and if so, how quickly are such measures resolved?

No, there is not.

7 Antitrust Law and Inequitable Conduct

7.1 Can antitrust law be deployed to prevent relief for patent infringement being granted?

There is some prospect of the Competition & Consumer Act 2010 (Cth) (CCA) being deployed against a patentee, but there has been no court decision in which this has occurred.

7.2 What limitations are put on patent licensing due to antitrust law?

Section 51(3) of the CCA provides an exemption from certain provisions of Part IV of the CCA (other than sections 46 and 46A (misuse of market power) and section 48 (resale price maintenance)),

Bird & Bird LLP Australia

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Jane OwenBird & Bird LLPLevel 11, 68 Pitt StreetSydney NSW 2000Australia

Tel: +61 2 9226 9888Email: [email protected]: www.twobirds.com

Rebecca CurreyBird & Bird LLPLevel 11, 68 Pitt StreetSydney NSW 2000Australia

Tel: +61 2 9226 9888Email: [email protected]: www.twobirds.com

Jane is a partner and head of the Intellectual Property practice of Bird & Bird in Sydney.

She has nearly 25 years’ experience in all aspects of intellectual property, including portfolio establishment, IP strategising, commercial-isation and enforcement. Her main sector focus is within life sciences, healthcare and education.

Specialising in contentious IP, Jane focuses on patent litigation, particularly in the life sciences sector. Her experience ranges across complex patent infringement/revocation, trademark and passing off, design infringement, disputes on ownership of IP and appeals from decisions of the Commissioner of Patents and the Registrar of Trade Marks. Jane’s litigation experience also allows her to advise clients in IP driven commercial transactions enabling them to minimise the risk of later disputes.

Hailed by Managing IP as ‘IP Firm of the Decade’ in 2015 and ‘European Patent Firm of the Year’ in 2017, Bird & Bird consistently remains at the forefront of intellectual property law.

Particularly commended for its strength in IP strategy and litigation, it’s this first-class reputation that allows the firm to attract and retain world-leading patent advisors and litigators.

The majority of the firm’s work is cross-border in nature, and they are regularly called to advise on ground-breaking patent cases. Due to their geographic spread, they are also able to litigate in some of the most prominent patent litigation jurisdictions, providing invaluable experience on the approach and attitude of the courts in different jurisdictions, which enables them to devise and tailor litigation strategies accordingly.

Not only does the firm have the range and depth of expertise, but with more than 300 specialist lawyers across 28 offices, they have numbers in force.

www.twobirds.com

@twobirdsIP

Rebecca is a senior associate in Bird & Bird’s Intellectual Property team in Sydney.

She has experience across all areas of intellectual property, in particular patents and trademarks.

Her focus is on the life sciences and healthcare space where she acts for a range of pharmaceutical companies in relation to both contentious and non-contentious matters.

Bird & Bird LLP Australia

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Chapter 7

Daniel Legal & IP Strategy

Brazil

The pre-trial stage may take an average of eight months. In cases where any party contests the court-appointed expert’s nomination, and depending on the complexity of the case, this schedule may be substantially delayed.Costs are generally borne by the losing party, in accordance with Article 20 of the Brazilian Civil Procedure Code. The court may award loss of suit costs covering court fees and the expenses incurred by the prevailing party, as well as the fees of expert witnesses and other related costs of the proceedings. The award may also include an amount covering loss of suit attorney fees, stipulated by the court. Loss of suit attorney fees is normally fixed at 10–20% of the overall award of damages (if any) as per Article 20, item 3 of the Civil Procedure Code. Note that the award of loss of suit attorney fees by the court is independent of the fee agreement reached between the parties and their attorneys; in other words, the prevailing party may still need to pay attorney fees even when the court makes an order for loss of suit fees in favour of his attorney.

1.3 Can a party be compelled to disclose relevant documents or materials to its adversary either before or after commencing proceedings, and if so, how?

Under Brazilian procedural law, there is no general obligation for a party to list or disclose documents, but the parties will usually submit documents which they consider relevant to support their own case. Documents are filed at court, but not served on the other side.The plaintiff is required to attach to the brief or complaint the documents which support his case, and to allow for further evidence which he intends to adduce in the proceedings. The defendant then does the same when filing the defence, challenging the plaintiff’s arguments and evidence.

1.4 What are the steps each party must take pre-trial? Is any technical evidence produced, and if so, how?

Each side submits its written arguments and documentary evidence. Parties may submit almost any kind of evidence before trial, from prior art references to technical and legal opinions. Technical experts are frequently used in patent litigation. Most of the attorneys have no technical background in Brazil. This is because technical experts are key players in infringement and validity litigation. The judge, however, may also appoint a court expert whenever the facts under discussion depend on technical or scientific knowledge, which is the case in virtually all infringement and validity lawsuits. Likewise, plaintiffs and defendants may also appoint technical assistants so as to provide guidance to the court-appointed expert, and to respond to his technical conclusions.

1 Patent Enforcement

1.1 Before what tribunals can a patent be enforced against an infringer? Is there a choice between tribunals and what would influence a claimant’s choice?

As a rule of thumb, enforcement is a matter of state jurisdiction. Each Brazilian state has a state court system and, therefore, infringement lawsuits can be filed before any state court, provided that other rules of civil procedure are observed. As a general rule, infringement lawsuits must be filed in the state where the accused infringer has its principal place of business or in any place where acts of infringement occurred.

1.2 What has to be done to commence proceedings, what court fees have to be paid and how long does it generally take for proceedings to reach trial from commencement?

An infringement lawsuit starts with the filing of an initial brief, where plaintiffs must assert their claims of infringement alleging that the accused product infringes a patent. Normally, the burden of proof falls on the plaintiff (except in the case of infringement of a process patent), who often presents documentary evidence upfront, including technical and legal options. After the defendant is duly served of the complaint, he normally has 15 days to file an answer, where all possible defences, including counterclaims of invalidity, shall be presented together with the supporting evidence. In an infringement case, both parties may request the court to allow the submission of further evidence during the proceeding; most importantly, the production of technical evidence by an expert to be appointed by the court at a later stage. The plaintiff then has a 10-day term to file a reply brief, before the judge decides on the requests made by each party regarding production of evidence. At this stage, the court may also identify issues that are not under dispute and decide any preliminary argument raised by the parties. If the production of technical evidence is required, the judge will then appoint a court expert to prepare a technical report that will be used to assist the court. Parties may elect their own experts to interface with the court-appointed expert and provide any clarification which he may need. Parties may also submit technical questions to be answered by the court expert relating to infringement and validity. After the court-appointed expert files his report with the court, and parties submit their own arguments in relation to such report, the judge will then set a date for closing arguments (written) and a date for trial. If no oral evidence is needed, the court may also render a final judgment without a trial.

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13 other Brazilian states, also has two chambers with jurisdiction to hear IP cases. Furthermore, the Federal Court of Appeals for the Third Circuit, with jurisdiction in São Paulo and Mato Grosso do Sul, also has specialised IP chambers (three out of 10). At state level, all major Brazilian cities have courts specialised in commercial and corporate law, including IP. For instance, the Rio de Janeiro state court has seven state courts with jurisdiction to hear commercial law cases, including IP cases.

1.9 What interest must a party have to bring (i) infringement, (ii) revocation, and (iii) declaratory proceedings?

Infringement lawsuits must be filed by the patent owner or by its exclusive licensee vested with powers, against anyone who may be infringing the patent. As to revocation and declaratory proceedings, the law provides that “any legitimate interested party” may file them (Article 56 of the Patent Law). This requirement is interpreted by courts very broadly; sometimes, it suffices to be a competitor or to work in the same field of technology.

1.10 If declarations are available, can they address (i) non-infringement, and/or (ii) claim coverage over a technical standard or hypothetical activity?

Yes. As long as there is uncertainty over a fact, and this uncertainty is causing an actual or imminent threat to the party’s right, a court may be requested to entertain a declaratory judgment, either affirmative or negative.

1.11 Can a party be liable for infringement as a secondary (as opposed to primary) infringer? Can a party infringe by supplying part of, but not all of, the infringing product or process?

Yes, a party can be held liable for contributory infringement or inducement. The Patent Law further provides that supplying a component of a patented product, or material or equipment for carrying out a patented process, provided that the final application of the component, material or equipment necessarily leads to the exploitation of the subject matter of the patent, is considered a crime of unfair competition.

1.12 Can a party be liable for infringement of a process patent by importing the product when the process is carried on outside the jurisdiction?

Yes. According to Article 42 of the Patent Law, a patent confers on its owner the right to prevent third parties from manufacturing, using, offering for sale, selling or importing for such purposes, without his consent, a process, or product directly obtained by a patented process. In addition, in the case of a process patent, the defendant has the burden to prove non-infringement, while in a product patent the burden of proof lies with the plaintiff.

1.13 Does the scope of protection of a patent claim extend to non-literal equivalents?

Yes. It is possible to establish direct infringement by the doctrine of equivalence. The Patent Law expressly provides that the patent infringement may be found “even if the violation does not affect all the claims of the patent or if it is restricted to the use of means equivalent to the subject matter of the patent”.

In patent litigation, where almost every case involves technical issues, an outcome on merit will often depend on the knowledge of an expert, or sometimes several experts. It is important to note, however, that the judge has the right to decide notwithstanding the conclusions of the court-appointed expert. In other words, the court expert’s report is not binding on the court’s ruling.

1.5 How are arguments and evidence presented at the trial? Can a party change its pleaded arguments before and/or at trial?

Ideally, when the trial is set, the court records are already completed, and the parties and the judge have read the briefs. During trial, the parties’ attorneys, their experts or witnesses will present evidence mostly orally. Each party may call up to 10 persons to testify, among witnesses and experts, but the judge may limit this number to a maximum of three for each side. The judge will question the witnesses separately and successively, starting with the plaintiff’s. The party’s representatives may also be called to put forward their evidence. The judge puts forward all questions and the parties may address the court with additional questions, besides the ones being made.According to Article 264 of the Civil Procedure Code, a plaintiff cannot change his pleadings or causes of action (arguments) once the defendant is served with the complaint, unless the defendant consents. The plaintiff cannot, under any circumstances, change his pleadings or causes of action after the judge renders a decision defining the issues in the case and the scope of the evidence production phase.

1.6 How long does the trial generally last and how long is it before a judgment is made available?

Trials generally take one day, but sometimes take longer depending on the complexity of the case and on the number of experts and witnesses called by each party. After trial, the judge is expected to make a judgment in 30 days. This deadline, however, is rarely met by the judge, who may take months to render a final decision, especially in cases involving a greater level of complexity.

1.7 Are judgments made available to the public? If not as a matter of course, can third parties request copies of the judgment?

Yes, judgments are public and third parties can request copies of the judgment. There are judgments under seal in special circumstances, but these are rarely seen in IP cases.

1.8 Are there specialist judges or hearing officers, and if so, do they have a technical background?

Specialist judges are not yet available. However, specialised IP courts have been created in recent years. In 2002, the Rio de Janeiro Federal Courts made some advances, creating four district courts (out of 47) with special jurisdiction to hear cases filed against the Brazilian Patent and Trademark Office (BPTO). These are still the only federal district courts specialised in IP matters in the country. At the appellate level, however, there have been developments. The Federal Court of Appeals for the Second Circuit, which has jurisdiction to decide appeals from Rio de Janeiro and Espirito Santo, for example, has two chambers (out of eight) specialised in IP cases. The Federal Court of Appeals for the First Circuit, with jurisdiction to decide appeals from the Federal District (Brasília) and

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1.18 Are (i) preliminary, and (ii) final injunctions available, and if so, on what basis in each case? Is there a requirement for a bond?

Yes, both kinds of injunctions are available. Preliminary injunctions may be granted as long as substantive evidence is submitted, and the court is convinced of (i) the likelihood of success on the merits, and (ii) the need for an urgent decision from courts to avoid irreparable harm. In granting a preliminary injunction, courts will balance the hardships and the effect of not doing so in cases where the injunction effects are irreversible. In order to avoid irreparable damages or damages that would be difficult to recover, the judge can even grant an injunctive order to suspend the violation or act of infringement before summoning the defendant (ex parte), ordering the plaintiff to post a bond or a fiduciary guarantee in cases where he deems it necessary.Permanent injunctions are also available, and are normally granted whenever a judgment of infringement is made, although a stay on the injunction may be determined by the Court of Appeals before the appeal has been decided upon by the court.

1.19 On what basis are damages or an account of profits assessed?

Under Article 210 of the Patent Law, loss of profits shall be determined by the most favourable of the following criteria: (i) the benefits that would have been gained by the injured party if the violation had not occurred; (ii) the benefits gained by the author of the violation of the rights; or (iii) the remuneration that the author of the violation would have paid to the proprietor of the violated rights for a granted licence which would have legally permitted him to exploit the subject of the rights (Article 210 of the Patent Law). It is possible to obtain compensation for acts of infringement which occurred between the date of publication of the application and that of the grant of the patent, or even before publication, if there is proof that the infringer has knowledge of the contents of application prior to publication (Article 44 of the Patent Law).

1.20 How are orders of the court enforced (whether they be for an injunction, an award of damages or for any other relief)?

The patentee can obtain in the civil sphere a preliminary restraining order, provided for in the current Patent Law, for the immediate cessation of the patent violation. Ex parte seizure of the infringing products can also be obtained when the judge is convinced that the plaintiff’s IP rights are seriously threatened by the defendant’s infringing activities. The plaintiff can request the courts to issue orders to destroy, to buy back stock or to deliver up the infringing goods. Damages (loss of profits) can be claimed by the plaintiff on the basis of Article 210 of the current Patent Law, which provides a triple criteria calculation.

1.21 What other form of relief can be obtained for patent infringement? Would the tribunal consider granting cross-border relief?

In addition to damages, it is also possible to obtain search and seizure orders and other immediate reliefs, such as preliminary and permanent injunctions. The tribunal would consider granting cross-border relief depending on the circumstances; for instance, shipment details, information on the importer, evidence that the incoming or imported product

1.14 Can a defence of patent invalidity be raised, and if so, how? Are there restrictions on such a defence e.g. where there is a pending opposition?

Yes. Invalidity may be raised as a defence in any infringement lawsuit. Defendants often use this kind of defence argument, combined with a non-infringement argument, in their response brief. However, it may be raised at any time during the proceedings. In order to revoke a patent with erga omnes effect, as from its filing date, a declaratory lawsuit of invalidity must be filed. In this kind of lawsuit, the BPTO is a mandatory defendant, together with the patentee, and because the BPTO is a federal entity, the invalidity proceeding must be filed at the Federal Court in Rio de Janeiro.Note, however, that the defence referred to would be an infringer’s reply to an infringement lawsuit. Accordingly, we are referring to a defence raised in an infringement proceeding at the state courts. A spontaneous invalidity lawsuit will have to brought at the Federal Courts, as the BPTO is a federal entity, and consequently a mandatory co-defendant. Post-grant (administrative) oppositions, ex officio or at the request of third parties with legitimate interest, can only be filed within six months from the patent grant at the BPTO.

1.15 Other than lack of novelty and inventive step, what are the grounds for invalidity of a patent?

In general terms, a patent may be invalidated whenever it is in violation of any provision of the Patent Law. Besides lack of novelty and inventive step, the most common grounds for invalidity are the following: (i) lack of enablement (Article 24, “[t]he specification must describe the subject matter clearly and sufficiently so as to enable a person skilled in the art to carry it out and to indicate, when applicable, the best mode of execution”); and (ii) lack of support in the specifications (Article 25, “[t]he claims must be based on the specification, characterizing the particulars of the application and defining clearly and precisely the subject matter to be protected”).

1.16 Are infringement proceedings stayed pending resolution of validity in another court or the Patent Office?

As a general rule, yes. However, if the validity challenge is raised when the infringement case is already in a later stage, the court may reject such kind of request.

1.17 What other grounds of defence can be raised in addition to non-infringement or invalidity?

The law guarantees protection to the person who, in good faith, has been exploiting the patented product or process prior to the date of filing or of priority of a patent application. The “prior user” has the right to continue the exploitation, without onus, in the previous form and under previous conditions (Article 45 of the Patent Law).In addition, although rarely, the laches doctrine in patent infringement lawsuits may be raised and accepted if the court is convinced that the patent owner knew about the infringing activities but delayed substantially to file the lawsuit, so as to increase potential damages.

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2 Patent Amendment

2.1 Can a patent be amended ex parte after grant, and if so, how?

No. Amendments are not allowed after a patent grant. However, a patentee may apply for a certificate of addition to protect an improvement or development introduced in the subject matter of the invention.

2.2 Can a patent be amended in inter partes revocation/invalidity proceedings?

Yes, although it is very unusual. There was one case where a court determined amendments to be made in a patent claim. In such cases, the Letters Patent will subsequently be endorsed.

2.3 Are there any constraints upon the amendments that may be made?

Yes. According to Article 32 of the Patent Law, applicants may only amend their claims until the request for examination, and provided that the amendments are supported by the initial disclosure. The BPTO has recently issued new Guidelines for amending patent applications. Voluntary amendments for correcting translation or typing errors can be made after the examination request if the specification fully supports them. Other examples of post-examination voluntary amendments that may be accepted by the BPTO are: I) inserting the context of a dependent claim into an independent one; II) restricting parameter range; or III) withdrawing an element originally presented as an alternative. The new Guidelines also indicate that elements originally included into an independent claim cannot be deleted, as this change could also imply that the scope of protection has been expanded.The Guidelines on voluntary amendments will become an important source and reference point for Brazilian Examiners when performing substantive examination on patent applications.

3 Licensing

3.1 Are there any laws which limit the terms upon which parties may agree a patent licence?

Yes. Licence agreements are subject to recordation in the BPTO in order to produce effects against third parties (Article 62 of the Patent Law) and whenever payment is remitted abroad. In the process of recording, the BPTO may provide limitations upon which parties may agree. The most critical limitation is on the consideration clause. The BPTO often issues office actions questioning payment methods whenever the licence agreement does not establish a “fixed amount per unit sold” or “a percentage on the net selling price”. The BPTO also limits tax deductions in order to limit the remittance of payments among colligated companies. Furthermore, the BPTO does not permit any compensation for patent applications.Another limitation provided by the law refers to improvements. Licence agreements executed in foreign countries often contain a clause providing that improvements belong to the licensor, even if made by the licensee. Nevertheless, the Brazilian Patent Law determines that any improvement on a licensed patent shall belong to the person who made it, thus guaranteeing the other party the right of preference with respect to a licence (Article 63 of the Patent Law).

reproduces and/or infringes the patented product in Brazil. In the context of the patent, this is not a simple task for Custom Officials. A generic claim will not be sufficient to obtain relief.

1.22 How common is settlement of infringement proceedings prior to trial?

The Brazilian Civil Procedure Code (CPC) expressly provides for a conciliation hearing to encourage parties to reach an amicable settlement before the evidence phase and before the judgment in the infringement lawsuit. Besides this, parties may, at any time, establish negotiations for an amicable settlement, also requesting a conciliation hearing. Note, however, that the patent holder will prefer to send Cease and Desist letters to the infringing party to avoid litigation. Accordingly, a considerable number of patent infringement cases are settled via Cease and Desist letters.

1.23 After what period is a claim for patent infringement time-barred?

Although the Brazilian Civil Code provides for a general three-year statute of limitations for filing damages lawsuits, the Patent Law establishes a five-year statute of limitations for patent infringement.

1.24 Is there a right of appeal from a first instance judgment, and if so, is it a right to contest all aspects of the judgment?

Yes. Parties can appeal the first instance judgment, and all aspects of the judgment may be reviewed by the Court of Appeals.

1.25 What are the typical costs of proceedings to first instance judgment on (i) infringement, and (ii) validity? How much of such costs are recoverable from the losing party?

Infringement or validity cases may cost from US$ 60,000 (sixty thousand dollars) in a very straightforward case, to over US$ 250,000 (two hundred and fifty thousand dollars) in more complex cases, especially when infringement and validity are dealt with in the same case.

1.26 For jurisdictions within the European Union: What steps are being taken in your jurisdiction towards ratifying the Agreement on a Unified Patent Court, implementing the Unitary Patent Regulation (EU Regulation No. 1257/2012) and preparing for the unitary patent package? For jurisdictions outside of the European Union: Are there any mutual recognition of judgments arrangements relating to patents, whether formal or informal, that apply in your jurisdiction?

No, not that we are aware of. The BPTO once considered harmon-ising patent examination proceedings amongst Latin American neighbouring countries, but this project has not materialised. At the moment, Brazil is more concerned with improving its IP system and reducing the backlog of patent cases.

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operating or surgical techniques and methods, as well as therapeutic or diagnostic methods for the treatment of humans or animals; and IX. the whole or part of natural living beings and biological material found in nature or also isolated therefrom, including the genome or germplasm of any natural living being and the natural biological processes.”In addition, Article 18 also provides that the following are not patentable: “I. that which is contrary to [accepted principles of] morality and good conduct and to public safety, order and health; II. substances, matter, mixtures, elements or products of any kind, as well as any modification of their physical-chemical properties and the respective processes of obtaining or modifying them, when they result from the transformation of the atomic nucleus; and III. the whole or part of living beings, except transgenic microorganisms which meet the three requirements for patentability – novelty, inventive step and industrial application – specified in Article 8 and which are not mere discoveries.”

5.2 Is there a duty to the Patent Office to disclose prejudicial prior disclosures or documents? If so, what are the consequences of failure to comply with the duty?

No, there is not.

5.3 May the grant of a patent by the Patent Office be opposed by a third party, and if so, when can this be done?

The grant of issue of the patent can be challenged by a third party within six months from said grant or issue date. These are known as administrative nullification proceedings or post-grant proceedings. Before the actual grant of the patent, third parties may file observations in the application. Said observations can be submitted from the publication of the application up to the conclusion of the examination (pre-grant “opposition”).

5.4 Is there a right of appeal from a decision of the Patent Office, and if so, to whom?

A decision rendered by the Patent Examiner granting, rejecting or shelving the patent application may be appealed to the President of the BPTO. The final decision rendered by the BPTO may be appealed to the Federal Courts in Rio de Janeiro, considering that the BPTO headquarters are located in Rio de Janeiro.

5.5 How are disputes over entitlement to priority and ownership of the invention resolved?

Disputes over priority or ownership may be resolved by the BPTO or by courts, and, in any case, the BPTO’s decisions are subject to judicial review. A priority claim must be proved by means of a suitable document of origin, containing the number, date, title, specification and, when they exist, claims and drawings, accompanied by a simple translation of the certificate of filing or equivalent document containing data identifying the application, the contents of which will be of the entire responsibility of the applicant. If two or more authors have independently devised the same invention or utility model, the right to obtain a patent will be assured to whoever proves the earliest filing, independently of the dates of invention or creation. The withdrawal of an earlier filing without producing any effects will give priority to the first later filing.

If there is an antitrust concern, the BPTO often questions non-competition clauses when the period is greater than five years after the end of the licence, and limits the term of the licence by the respective patent term.

3.2 Can a patent be the subject of a compulsory licence, and if so, how are the terms settled and how common is this type of licence?

Yes. Patents may be subject to compulsory licence. There are several grounds for granting such licences, including in cases of abuse of patent rights or abuse of economic power, in cases of non-exploitation of the subject matter of the patent in the Brazilian territory, or in cases of a lack of manufacture or incomplete manufacture of the product. In these cases, the licence can only be requested by a party with a legitimate interest, and this has the technical and economic capacity to carry out the efficient exploitation of the subject matter of the patent that should be destined predominantly for the internal market. A compulsory licence, based on lack of local or incomplete manufacture, may only be requested after three (3) years of the grant of the patent.Compulsory licences may also be declared by the Executive Power, independent of any request, in cases of national emergency or public interest, as long as the patentee or his licensee does not meet such necessity.Compulsory licences will always be granted without exclusivity; sublicensing is not permitted.Although there are numerous hypothetical situations when a compulsory licence may be granted, this kind of licence is rare. There was one case in 2007 where a compulsory licence was granted on a pharmaceutical patent on the grounds of public interest.

4 Patent Term Extension

4.1 Can the term of a patent be extended, and if so, (i) on what grounds, and (ii) for how long?

As a general rule, no. However, there is a patent category, called the pipeline patent, that may be subject to term extension requests, based on extensions granted in the country where the first application was filed, essentially for the revalidation of patents granted abroad (Article 230, § 4 of the Patent Law).Brazil has allowed pipeline patent applications to be filed for a period of one year since the enactment of the current Patent Law (Law No. 9,279 of May 15, 1996), for products obtained by chemical means or processes and food and chemical-pharmaceutical products, since this subject matter was not patentable under the previous law.

5 Patent Prosecution and Opposition

5.1 Are all types of subject matter patentable, and if not, what types are excluded?

No. According to Article 10 of the Patent Law, the following are not patentable: “I. discoveries, scientific theories and mathematical methods; II. purely abstract concepts; III. schemes, plans, principles or methods for commerce, accounting, financing, education, advertising, lottery and control; IV. literary, architectural, artistic and scientific works, or any aesthetic creation; V. computer programs per se; VI. presentation of information; VII. rules of a game; VIII.

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8 Current Developments

8.1 What have been the significant developments in relation to patents in the last year?

Update on ANVISA’s ExaminationOn April 12, 2017, ANVISA and the Brazilian PTO published a version of the new joint Guidelines #1/2017. The Guidelines set out the new workflow between ANVISA and the Brazilian PTO in terms of the examination of pharmaceutical patent applications. Article 4 of the Guidelines establishes that ANVISA will ascertain whether a patent application contravenes public health. The criterion for conflicting with public health is when a product or process presents a “health risk”. This risk is detected when a product comprises a substance that has been prohibited in Brazil, or when a process results in said substance. Accordingly, when the subject matter of the patent application is found to pose a health risk, ANVISA will deny prior approval, and will send the application back to the Brazilian PTO for further handling. Following this, the PTO will publish final dismissal of the application. The Interagency Ordinance designs a new approach in pharma patent examination of products and processes of interest under the Brazilian Government’s drug policies and pharmaceutical assistance from the National Healthcare System (SUS). In practice, ANVISA will examine such applications and render a technical opinion as to whether the claims meet the patentability requirements under Brazilian law. ANVISA’s opinion will be directed to the Brazilian PTO to serve as a basis for third party observations, as provided in Article 31 of the Brazilian Patent Law 9.279/96.The novelty brought by the Ordinance is in Article 9 which creates an Interagency Group, namely ANVISA and the Brazilian PTO. The Group seeks to “harmonise” its understanding of the application of patent law and practice in certain fields, such as Markush claiming, selection inventions, the patentability of new uses, salts polymorphs and antibodies, as well as other issues inherent to the pharma industry. Fast-Track ExaminationDuring the last two years, the Brazilian PTO has issued important Resolutions directed to priority or fast-track examination of patent applications. Resolution 14/2015 enacted a PPH Pilot Programme for applications covering oil and gas technology between the US and Brazilian Governments. In a similar vein, Japan and Brazil have negotiated a PPH Pilot Programme (Resolution 184/2017) for information technology, but to qualify for this programme, the applications have to be classified under specific international patent classification symbols. Moreover, Resolution 175/2016 provides permanent fast-track examination for green technology inventions following four consecutive Pilot Programmes. Very recently, the PTO published Resolution 191/2017 regulating fast-track examination for applications filed by science and technology institutes.Priority examination or fast-track examination is available for the following situations:■ applications filed by small entities;■ applications filed by senior citizens;■ applications filed by citizens suffering from health conditions;■ applications infringed by third parties;■ pharma applications relating to treatment of certain diseases,

such as cancer, AIDS and neglected diseases; ■ green technology applications;■ applications under the PPH Pilot Programme; and■ applications filed by science and technology institutions.

5.6 Is there a “grace period” in your jurisdiction, and if so, how long is it?

Yes, there is. The grace period is 12 months, and the disclosure of an invention or utility model shall not be considered state of the art if it occurs during the 12 months preceding the filing date or priority date of the patent application when made by: I) the inventor; II) the National Institute of Intellectual Property through the official publication of the patent application filed without the consent of the inventor based on the information obtained from him or resulting from his acts; or III) third parties, on the basis of information obtained directly or indirectly from the inventor.

5.7 What is the term of a patent?

The term of a patent of invention shall be twenty (20) years and that of a utility model patent shall be fifteen (15) years counted from the filing date of the application. This term shall be no fewer than ten (10) years for an invention patent, and seven (7) years for a utility model patent counted from the date of grant, except where the Instituto Nacional da Propriedade Industrial (INPI) is prevented from carrying out the substantive examination of the application, owing to a duly evidenced judicial dispute, or for reasons of force majeure.

6 Border Control Measures

6.1 Is there any mechanism for seizing or preventing the importation of infringing products, and if so, how quickly are such measures resolved?

Yes. The Customs Authorities, ex officio or at the request of an interested party, may seize infringing products entering the Brazilian borders. Nevertheless, the interested party is generally required to file a criminal or civil lawsuit within 10 days, seeking injunction relief in order to keep the importation stayed, and eventually requesting the destruction of the goods. This kind of measure is more common (and simpler) in cases of trademark infringement.

7 Antitrust Law and Inequitable Conduct

7.1 Can antitrust law be deployed to prevent relief for patent infringement being granted?

Yes, but this is very unusual in Brazil. During the past year, the BPTO and the antitrust authorities reached some agreements to facilitate tracking and monitoring patent cases, but there are still many uncertainties in terms of how this control will be implemented, what actions will be taken, and on what grounds they will be based.

7.2 What limitations are put on patent licensing due to antitrust law?

The answer to question 3.1 would be applicable here.

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There is a plan to increase the number of patent examiners in 2018 in continuity of the Brazilian PTO’s drive for efficiency. The number of annual patent filings has remained stagnant in the last two years but has not decreased significantly so as to raise concern. Statistics show that deep pocket investors/companies who have been established for many years in Brazil will continue to invest to protect innovation.

8.3 Are there any general practice or enforcement trends that have become apparent in your jurisdiction over the last year or so?

The new Procedure Code 13.105/2015 which regulates the proceedings of most civil lawsuits, and which became effective in March 2016, has proven to be less bureaucratic and has brought fast and effective solutions to legal disputes. Pursuant to Article 191 of the Code, judges and the parties in a case may establish a specific procedural timetable for the conduction of judicial proceedings. This piece of legislation is a breakthrough in enforcement. This clearly shows a trend of an awareness of the importance of IP rights and the consequences of third parties trespassing on these rights. As legal disputes are expected to be decided expeditiously, judges should resort to damages as provided for in Brazil’s Patent Law.

AcknowledgmentThe authors would like to thank Ricardo Nunes for his assistance in preparing this chapter. Ricardo Nunes is a partner at Daniel Legal & IP Strategy, specialising in patent litigation.Tel: +55 21 2102 4327 / Email: [email protected]

Proposal to Eliminate Backlog of Patent ApplicationsThe Brazilian Government is considering an emergency measure to eliminate the Patent Office’s chronic backlog problem by automatically granting 230,000 pending applications by 2020. The Government labelled this proposed emergency measure an “extraordinary solution” to the problem, and a draft of the plan will be introduced for public discussion soon.The current proposal entails a simplified examination procedure in which the Patent Office would automatically grant unopposed applications filed before 2014 but yet to be examined by them. This measure, however, does not include either pharmaceutical applications or divisional applications where the parent application has been examined. This “extraordinary solution” does have an at-will applicant opt-out clause and interested third parties would have up to 90 days to file pre-grant oppositions after an application is pre-approved for an automatic grant.

8.2 Are there any significant developments expected in the next year?

Brazil’s high-profile political corruption investigation ‘Operation Car Wash’ has completed its third year, and has shaken the Brazilian Government to its core. Brazil’s economy is now showing signs of recovery and consumer and business confidence is rising. The approval of fiscal reform, lower inflation and declining interest rates should push the country towards gradual recovery, but improvement should only materialise by 2018. Companies will most probably continue to seek IP protection in Brazil as the market continues to be important, regardless of the major obstacle of the Brazilian PTO’s inadequate infrastructure, which has resulted in the worst backlog ever of patent examinations.

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Rana GosainDaniel Legal & IP StrategyAv. Republica do Chile, No. 230 3rd FloorCentro, CEP 20031-170Rio de Janeiro, RJBrazil

Tel: +55 21 2102 4205Email: [email protected]: www.daniel-ip.com

André Bastos VenturiniDaniel Legal & IP StrategyAv. Republica do Chile, No. 230 3rd FloorCentro, CEP 20031-170Rio de Janeiro, RJBrazil

Tel: +55 21 2102 4314Email: [email protected]: www.daniel-ip.com

Rana Gosain is a Senior Partner at Daniel Legal & IP Strategy. Mr. Gosain has over 30 years of experience in Intellectual Property. His expertise covers Patents, Designs and Litigation Strategies, with a special focus on Life Sciences and Legal Pharmaceutical issues. Rana counsels clients on Patent Filing Strategies and obtaining the best patent protection.

Rana has a technical background in Civil Engineering, and completed a law course in 2005. He is a Brazilian IP agent and a Brazilian Bar Association-registered attorney. He also holds a postgraduate degree in Intellectual Property from the Pontifical Catholic University in collaboration with the Brazilian Patent and Trademark Office. He has a strong focus on life sciences, and is on the International Association for the Protection of Intellectual Property (AIPPI) Standing Pharmaceutical Committee.

Rana’s current role at Daniel Legal & IP Strategy involves advising clients on the full range of Intellectual Property matters and developing strategies for protecting and managing IP portfolios.

Daniel Legal & IP Strategy is a top-tier Brazilian law firm specialized in protecting your intellectual property here in Brazil and throughout LATAM. As our name suggests, Daniel balances aggressive traditional legal remedies with new consulting and business services to provide you the customized, modern, and comprehensive protection you need to establish, continue, or expand your business operations here.

With our business focus and entrepreneurial approach, we provide services that add true value to your business. And we pride ourselves on differentiated client communication and service. Daniel’s partners are well-known and published experts in their respective fields with broad experience in Brazil and internationally.

With this depth and diversity of experience, we build teams that deliver innovative solutions and measured value. And with flawless ethics, we build lasting and trusting relationships across our entire portfolio of clients – from the traditional Fortune 500 to the determined startups.

André Bastos Venturini has more than a decade of experience working with Patents and Industrial Designs. André is responsible for the Patent Department of Daniel Legal & IP Strategy, and has an in-depth knowledge of drafting patent applications and patentability, nullity, infringement and Freedom to Operate (FTO) analyses. He has also worked as a technical expert in several lawsuits, including the first disputes concerning software-implemented inventions and SEPs in Brazil.

André graduated in Electrical Engineering, and also holds Master’s degrees from the Military Institute of Engineering, one of Brazil’s most recognised universities, and from the École Centrale de Lyon in France. He is a Brazilian IP agent and active member of the Brazilian Intellectual Property Association (ABPI) and the International Association for the Protection of Intellectual Property (AIPPI). André constantly publishes articles and is an invited speaker in many conferences in his area of activity.

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Chapter 8

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1.4 What are the steps each party must take pre-trial? Is any technical evidence produced, and if so, how?

The pre-trial claim will start by means of a brief filed before the Civil Court. The mentioned brief will be as complete as possible and, in any case, very similar to what is to be claimed in the legal action, if the latter is filed after the exhibition of documents.

1.5 How are arguments and evidence presented at the trial? Can a party change its pleaded arguments before and/or at trial?

The arguments are presented in writing. In addition, the evidence will be presented according to the rules of the Civil Procedural Code, which regulates what kind of evidence is allowed and how the evidence is to be brought to the Court.

1.6 How long does the trial generally last and how long is it before a judgment is made available?

There is no concrete answer to this question. In addition, local practice indicates that several cases finish by means of a settlement.

1.7 Are judgments made available to the public? If not as a matter of course, can third parties request copies of the judgment?

In principle, court rulings are made accessible to the public. That being said, a distinction has to be made between civil and criminal matters. In civil cases, the entire process is considered public knowledge, with every step of the procedure, including the ruling, being made available as they progress. In criminal cases, some parts of the proceedings can be kept secret to ensure a swift process and investigation. This is beside the fact that final sentences/judgments are made available to the general public.

1.8 Are there specialist judges or hearing officers, and if so, do they have a technical background?

The Civil Courts and the Criminal Courts called to hear patent infringement cases in Chile are the Ordinary Courts of Justice. The judges within the Courts and the Appeals Court (Chambers) are all lawyers, and do not have a technical background. However, in most of the procedures, the Court will call for an expert with the necessary background in the technology in discussion. In addition,

1 Patent Enforcement

1.1 Before what tribunals can a patent be enforced against an infringer? Is there a choice between tribunals and what would influence a claimant’s choice?

When it is necessary to enforce patent rights which are the subject of infringement, the Chilean Industrial Property Law (Law 19,039, “the Law”) provides for civil actions and criminal actions. The claimant’s choice will typically be influenced by the kind of goods/processes/methods protected by the patent, and which are being “copied”, by the place (region of Chile) where the infringement is taking place, by the possible cross-border implications of the case, by the existing case law, if any, and by the internal codes of conduct of the claimant. The latter considers cases where some companies simply refrain from suing criminally.

1.2 What has to be done to commence proceedings, what court fees have to be paid and how long does it generally take for proceedings to reach trial from commencement?

No court fees are to be paid. The civil action will commence by means of a “formal legal action” or by means of a “pre-trial measure” or by a “preliminary injunction”. In this last case, a bond will normally be requested by the Court. The criminal actions will usually commence by means of a claim before the Office of the Criminal Prosecutor. Strictly speaking, a criminal action could also start by means of a “complaint made at the Police Station”, since such authority will have to send the complaint to the Prosecutor for further investigation.

1.3 Can a party be compelled to disclose relevant documents or materials to its adversary either before or after commencing proceedings, and if so, how?

The answer is yes, provided that the claimant has filed a pre-trial measure or claim called “medida prejudicial probatoria” requesting the Court to summon the defendant (future defendant) to show the documents of evidence that are in his possession, and that are, or could be, evidence for a “complete civil action” which the claimant is willing to bring before the Court, provided that the evidence is made available, and with the understanding that the claimant does not have this required evidence.

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1.14 Can a defence of patent invalidity be raised, and if so, how? Are there restrictions on such a defence e.g. where there is a pending opposition?

If two parties are fighting on several fronts, namely before a Civil Court, a Criminal Court and/or the Chilean Patent and Trademark Office (INAPI) (in this last case, opposition lodged against a pending patent application or cancellation action filed against a granted patent), each case will be prosecuted independently of one another. However, the case law indicates that in many cases, the defendant in a civil and/or criminal action will file a cancellation action as a strategic means to try to defeat the claimant and the owner of the granted patent on which such claimant has based its civil and/or criminal action. The practice indicates that in spite of the independence of the procedures for each action, an action in one of the cases will, in all probability, have influence or at least slow down the procedure of one of the other actions.

1.15 Other than lack of novelty and inventive step, what are the grounds for invalidity of a patent?

The cancellation of a patent will be declared [authors’ note: after a legal action, which is to be initiated and prosecuted by any interested party] in one of the following circumstances: a) when the individual who obtained the patent was not the inventor nor the assignee; b) when the granting of the patent was based on official actions [authors’ note: examination reports] that were wrong or frankly deficient; or c) when the patent was granted in contradiction or against the provisions of the Law on patentability.

1.16 Are infringement proceedings stayed pending resolution of validity in another court or the Patent Office?

This is not applicable.

1.17 What other grounds of defence can be raised in addition to non-infringement or invalidity?

This is not applicable.

1.18 Are (i) preliminary, and (ii) final injunctions available, and if so, on what basis in each case? Is there a requirement for a bond?

Preliminary injunction is available. However, the granting of the same is not mandatory for the Court. In addition, the Court may decide to grant the injunction without prior hearing of the defendant or, in some cases, accept to grant an injunction prior to the hearing of the defendant. Normally, a bond is required. Final injunctions are also available.

1.19 On what basis are damages or an account of profits assessed?

The Chilean Intellectual Property Law states very clearly that “the claimant will have the right to choose the normal general rules (i.e. the Civil Procedural Code) or use the following rules: a) the profits that the owner of the intellectual property (IP) rights [authors’ note: namely a patent right] did not receive as a consequence of the infringement suffered; b) the profits obtained by the infringer as a consequence of the infringement; and c) the price that the infringer

the parties will have the opportunity, during the procedure, to file technical opinions regarding the case.

1.9 What interest must a party have to bring (i) infringement, (ii) revocation, and (iii) declaratory proceedings?

The Industrial Property Law is rather broad regarding this question. In fact, it is to be said that the rights granted on a patent in Chile are exclusive to the owner of the patent. Such exclusivity allows the owner to use his patent exclusively, to make it part of any commercial and legal act, to transfer the same by means of succession and, finally, to prevent any third party from using the invention protected by the patent, without his prior consent.In addition, the Law states that [authors’ note: the following texts are unofficial translations of parts of the Law]: a) any interested party will be entitled to file an opposition against […] a patent application […]; b) any interested party will be entitled to request the cancellation of an industrial property right [authors’ note: namely a patent]; c) the owner of an industrial property right [authors’ note: namely a patent] that is being infringed will be entitled to bring a civil action; and d) the owner of a patent will have to mark the patented objects with the letters P.I. [authors’ note: this acronym stands for “patente de invención”], followed by the number of the granted patent. The patented processes are excluded from this obligation, and the omission of this obligation will preclude the patent-owner from using the criminal actions provided by the Law [authors’ note: the civil actions are still available].

1.10 If declarations are available, can they address (i) non-infringement, and/or (ii) claim coverage over a technical standard or hypothetical activity?

This is not applicable.

1.11 Can a party be liable for infringement as a secondary (as opposed to primary) infringer? Can a party infringe by supplying part of, but not all of, the infringing product or process?

In principle, yes, since the articles of the Law that establish the criminal conducts are very broad. The same can be said in the case of the articles providing for civil actions.

1.12 Can a party be liable for infringement of a process patent by importing the product when the process is carried on outside the jurisdiction?

Yes, parties can be liable.

1.13 Does the scope of protection of a patent claim extend to non-literal equivalents?

This situation would need to be analysed on a case-by-case basis. The subject matter of the patent, the disclosure made in the specifications, and the final contents of the claims at the end of the prosecution of the application will determine the precise scope of protection and therefore the answer to this question.

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summon the losing party to pay for the trial. It is to be noted that such costs are normally symbolic.

1.26 For jurisdictions within the European Union: What steps are being taken in your jurisdiction towards ratifying the Agreement on a Unified Patent Court, implementing the Unitary Patent Regulation (EU Regulation No. 1257/2012) and preparing for the unitary patent package? For jurisdictions outside of the European Union: Are there any mutual recognition of judgments arrangements relating to patents, whether formal or informal, that apply in your jurisdiction?

This is not applicable.

2 Patent Amendment

2.1 Can a patent be amended ex parte after grant, and if so, how?

Once granted, a patent cannot be amended ex parte. In addition, since our law does not provide for “continuations in part”, in cases where the owner of a patent files a new patent application for an improvement of the technology, the new application will need to comply with the patentability requirements provided by law.

2.2 Can a patent be amended in inter partes revocation/invalidity proceedings?

The cancellation action filed by a party against a granted patent can result in the complete cancellation of the patent or in a partial cancellation of same. Therefore, if we consider the partial cancellation as an amendment of the granted patent, the answer to this question would be yes.

2.3 Are there any constraints upon the amendments that may be made?

As discussed above, this does not apply to pending applications; therefore, the answer would be no.

3 Licensing

3.1 Are there any laws which limit the terms upon which parties may agree a patent licence?

A patent licence will be agreed by the parties in total liberty, being the contract executed, “the law of the parties”. No boundaries apply, with the exception of the normal limits of private law. The sole provision of the current Industrial Property Law regarding this matter makes the registration of the licence with the INAPI mandatory, in order that such licence may produce effects against third parties.

3.2 Can a patent be the subject of a compulsory licence, and if so, how are the terms settled and how common is this type of licence?

The compulsory licence is established in the Industrial Property Law for very specific cases, namely: a) when the owner of a granted patent has suffered unfair competition practices […];

would have paid to the owner of the right [authors’ note: namely a patent right] in cases where he (the infringer) would have been granted a licence, taking into account the commercial price of the right infringed and the price of the licences in force”.

1.20 How are orders of the court enforced (whether they be for an injunction, an award of damages or for any other relief)?

It will vary depending on the order to enforce. For instance, sale prohibitions are enforced by a Court notice addressed to the person appointed as keeper of the infringing goods; goods seized and taken into the custody of the court are held by the police, etc. In the case of recovering of damages, if the defendant does not voluntarily comply, this is enforced by seizure of products and subsequent public sale by public auction.

1.21 What other form of relief can be obtained for patent infringement? Would the tribunal consider granting cross-border relief?

Cross-border relief is normally not claimed or granted.

1.22 How common is settlement of infringement proceedings prior to trial?

The settlement of infringement proceedings prior to trial is rather common.

1.23 After what period is a claim for patent infringement time-barred?

The statute of limitations for cancellation action of a granted patent is five years from the granting of the patent.The statute of limitations for civil and criminal actions in the case of patent infringement is five years counted in principle from the beginning of the infringement. However, in the case of “continuous infringement”, counting begins at the the conclusion of the infringement.

1.24 Is there a right of appeal from a first instance judgment, and if so, is it a right to contest all aspects of the judgment?

In the case of patent oppositions and patent cancellation actions [authors’ note: these are filed and prosecuted before the INAPI], the parties will be entitled to file an appeal before the Industrial Property Appeals Court. The decision of the Industrial Property Appeals Court could, thereafter, be the object of an annulment recourse before the Supreme Court. In the case of patent infringement cases, these are to be filed before a Civil Court and/or a Criminal Court. The decisions of these First Instance Courts can be appealed before the Ordinary Courts of Appeals. The decision of the Industrial Property Appeals Court could, thereafter, be the object of an annulment recourse before the Supreme Court.

1.25 What are the typical costs of proceedings to first instance judgment on (i) infringement, and (ii) validity? How much of such costs are recoverable from the losing party?

Costs are very different from one case to another. The Court may

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■ economic and financial methods, plans, principles, etc.;■ surgical, therapeutical methods and methods of diagnosis,

with the exception of the products used for such methods;■ new use, new shape, new dimensions, new proportions, new

materials of objects or new applications to known objects or elements. However, an invention consisting in the second use of a product, object or element is patentable, as such a new use may solve a technical problem which had no equivalent solution, and provided that such an invention (second use) will comply with the patentability requirements provided by the Law; and

■ part of the living beings as found in nature and natural biological processes, in addition to the biological material that can be found in nature or which can be isolated, including genomes and germplasm. However, the methods/processes that may use one or more of the biological materials mentioned above will be patentable if such methods/processes comply with the patentability requirements provided by law, and provided that such biological material is described and that the industrial applicability of the invention is made clear in the text of the application.

5.2 Is there a duty to the Patent Office to disclose prejudicial prior disclosures or documents? If so, what are the consequences of failure to comply with the duty?

The specifications of a patent application will need to refer to the prior art. In addition, it is the applicant’s responsibility to disclose the elements/documents that may affect the novelty of his invention.In addition, the applicant of a patent application which has been filed (and is prosecuted) abroad (outside of Chile) will have to file with the INAPI the search reports issued by the foreign Patent Offices before which an application is being prosecuted for the same invention. The failure to comply with such a duty may result in a cancellation action filed by a third party on the grounds that the examiner, at the time of reviewing the application, lacked elements for an appropriate examination of the application.

5.3 May the grant of a patent by the Patent Office be opposed by a third party, and if so, when can this be done?

A patent application can be opposed by third parties. In fact, in the early stages of the prosecution of a patent application, the Patent Office will submit the application to a formal examination. If the application complies with the basic formal requirements provided by Law, the application will be admitted to ordinary proceedings and, in consequence, the applicant will be entitled to publish the application in the Official Gazette. The publication will open a special term (45 working days) for third parties to file, in writing, possible oppositions.

5.4 Is there a right of appeal from a decision of the Patent Office, and if so, to whom?

The decisions of the INAPI acting as the Court of First Instance can be appealed before the Industrial Property Appeals Court (Tribunal de Propiedad Industrial).Thereafter, the decision of the Appeals Court can be the subject of an annulment recourse before the Supreme Court of Chile.

b) matters concerning public health, national security, national emergency […]; and c) when the compulsory licence will permit the exploitation (use) of a later patent that cannot be exploited (used) without infringement of a prior/older patent. The three causes are to be determined by different authorities, and are the consequence of a legal procedure. Some of the causes, namely the ones indicated under points a) and c) above are still discussed from an academic point of view, since they can be considered as rather particular.In any case, these are not common at all. We would venture so far as to state that the provisions have not been used as yet.

4 Patent Term Extension

4.1 Can the term of a patent be extended, and if so, (i) on what grounds, and (ii) for how long?

Patents are granted for 20 years, counted as from the filing date. In addition, the term of a patent can be extended, provided that the following grounds are used and rules followed: a) the request of extension of the term of the patent is made by the patent-owner within six months from the date of granting; b) the prosecution of the application which resulted into a granted patent was the subject of a lengthy prosecution (length due to administrative reasons and/or reasons which cannot be explained or which lack justification); and c) the prosecution has lasted more than five years counted from filing date or three years counted from the request of examination of the patent.The additional protection or extension of term, if granted, will be granted only for a term proved to be an administrative and unjustified delay on the part of the authority (the INAPI).

5 Patent Prosecution and Opposition

5.1 Are all types of subject matter patentable, and if not, what types are excluded?

A patent application must comply with the following requirements in Chile:a) Formal Requirements:

(i) Filing of a patent application composed by the chapters/parts requested by the Law and its ruling, namely application, abstract, specifications, and a set of claims and figures.

(ii) Prosecution of the patent application according to the procedure established by the Chilean Industrial Property Law. Filing and prosecution are to be made at the INAPI.

(iii) Compliance of the application with the “Unity of Invention Principle”.

b) Requirements of Substance: (i) Subject matter not included among the “non-patentable

subject matters.* (ii) Novelty (absolute novelty). (iii) Inventive step or non-obviousness. (iv) Industrial applicability.

*Examples of non-patentable subject matters as established in the Law include the following:■ discoveries, scientific theories, mathematical methods;■ plants and animals, with the exception of microorganisms

which comply with patentability requirements;

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7.2 What limitations are put on patent licensing due to antitrust law?

In principle, none, in the sense that the antitrust law does not specifically provide for this situation. However, since the drafting of the antitrust law is rather broad and the antitrust authorities have ample powers, it is possible to imagine, at least theoretically, of a case where antitrust law could be put forward if a licensor and licensee (exclusive licence) were to allegedly agree on a licence in order to “block” a competitor, “constitute a monopoly”, “abuse a position”, or “reach agreement on prices”, etc.

8 Current Developments

8.1 What have been the significant developments in relation to patents in the last year?

■ At this time, there is a Bill in Congress for a “new Industrial Property Law”. The discussion of such is on hold and may restart during the next year.

■ Chile was one of the signatories of the Trans-Pacific Partnership Treaty. Implementation of said Treaty is on hold, and will depend upon several factors of international politics.

■ Chile is a founder country of the Pacific Alliance (comprising Chile, Colombia, Mexico and Peru).

■ Another significant development is the execution of a Patent Prosecution Highway (PPH) with the countries of the Pacific Alliance.

■ Back in 2012, the Chilean Patent Office was designated by the World Intellectual Property Organization as an International Searching Authority/International Preliminary Examining Authority. In October 2014, the Chilean Patent Office started fulfilling its duties in this role.

8.2 Are there any significant developments expected in the next year?

■ Possible re-opening of the discussion of the Bill that is in Congress, mentioned under question 8.1 above.

■ There may be discussion of other PPH agreements with other countries.

8.3 Are there any general practice or enforcement trends that have become apparent in your jurisdiction over the last year or so?

General comments: new public funds for development of innovation and assistance for patenting; important increase of the number of patent applications filed by universities in Chile and under the PCT system; and reduction of the patent applications filed by foreign companies in the pharmaceutical field and in the mining field.Enforcement trends: in the case of enforcement of rights, civil actions are more common than criminal actions.

5.5 How are disputes over entitlement to priority and ownership of the invention resolved?

The final answer will mainly depend on a response (at least) to the following questions: (a) Is this a criminal case, and was the invention stolen by one person from another? (b) When will the discussion take place, namely before the filing of the application, during the prosecution of a patent application, or once the patent has already been granted? (c) Is there also a question of co-ownership? (d) Is there a dispute between employer and former employee, etc.?

5.6 Is there a “grace period” in your jurisdiction, and if so, how long is it?

The Industrial Property Law provides for a special “grace period” of 12 months. The Law refers to a possible innocuous disclosure – which occurred in the 12 months prior to the filing of the application – that will not be taken into account at the time of reviewing the novelty of the application. Some requirements are to be complied with and the Patent Office must be informed of these at the time of the filing of the application.

5.7 What is the term of a patent?

The patents are granted for a term of 20 years, counted from the filing date.

6 Border Control Measures

6.1 Is there any mechanism for seizing or preventing the importation of infringing products, and if so, how quickly are such measures resolved?

Chilean Customs are very effective, especially in the case of trademark infringements. In addition, Customs are entitled to temporarily seize or freeze products that could be infringing IP rights. In that case, Customs will contact the owner of the rights or its representative in Chile. It will take five days to initiate criminal actions.

7 Antitrust Law and Inequitable Conduct

7.1 Can antitrust law be deployed to prevent relief for patent infringement being granted?

In principle, the answer is no. However, the antitrust authority filed an action against a patent-owner arguing “abuse of dominant position”. The case ended via settlement last month. Therefore we can foresee that the antitrust authority could repeat an action of this nature in the future.

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Chile

Cristóbal PorzioPORZIO ∙ RIOS ∙ GARCIAAvenida Cerro El Plomo 5680, 19th FloorLas Condes, SantiagoChile

Tel: +56 2 2729 06 00Email: [email protected]: www.porzio.cl

Marcelo CorreaPORZIO ∙ RIOS ∙ GARCIAAvenida Cerro El Plomo 5680, 19th FloorLas Condes, SantiagoChile

Tel: +56 2 2729 06 00Email: [email protected]: www.porzio.cl

Education:

Attorney at Law, Pontificia Universidad Católica de Chile, 1994.

Franklin Pierce University (Concord, New Hampshire, USA), specialisation course in Intellectual Property, 1996.

Biography:

Partner at PORZIO ∙ RIOS ∙ GARCIA.

His areas of practice are focused on advising clients and litigation in matters of trademarks, patents, technology transfer, copyright, and strategies for the protection of IP rights. He also represents the firm’s clients in matters of negotiation and contracts related to industrial property and in subjects such as unfair competition and advertising. His practice also includes distribution and franchising law.

He participates on the board of directors of various companies and serves as counsel for foreign companies in Chile.

Other titles:

Professor of IP Law at the Pontificia Universidad Católica de Chile.

Former Member of the Board of the Chilean Association of Intellectual Property (ACHIPI), the Chilean Group of the AIPPI (2008–2017).

Former President of ACHIPI (2014–2017).

Publications:

Articles on intellectual property, distribution and franchising in various journals.

Memberships:

Chilean Bar Association.

Association Internationale des Jeunes Avocats (AIJA), Member of Honor.

International Distribution Institute (IDI), Chilean Expert.

ACHIPI; AIPPI; AIPLA; and INTA.

Languages:

Spanish; English; French; and Italian.

The law firm of PORZIO ∙ RIOS ∙ GARCIA was founded, in 1993, as Porzio, Ríos & Asociados, beginning its activities mainly in the Intellectual Property field.

Its specialised professional services, together with the command of several languages, led its clients, both Chilean and foreign, to entrust the firm with other legal matters in different fields of law, motivating the firm to also develop other areas of the legal profession in order to provide its clients with a full legal service, in addition to its traditional leading IP Services.

PORZIO ∙ RIOS ∙ GARCIA consists of a team of lawyers who graduated from the most prestigious universities in the country, many of whom have completed graduate degrees in foreign universities with a comprehensive command of different languages. Many of them also act as arbitrators in domestic and international procedures, and are academics at the main law schools in the country.

The team is completed by an entrenched group of paralegal and administrative staff with extensive experience. In order to deal with patent applications and patent litigation, a team of scientists in the fields of chemistry, pharmaceuticals, biochemistry and drawings works alongside our team of lawyers.

Education:

Attorney at Law, Universidad de Chile, 1998.

Universidad del Desarrollo, Diploma in New Company Law, 2002.

Universidad del Desarrollo, Diploma in Procedural Law and Oral Litigation, 2005.

Biography:

Partner at PORZIO ∙ RIOS ∙ GARCIA.

His areas of practice are focused on advising clients and litigation in matters of commercial brands, patents, technology transfer, and copyright. He also represents the firm’s clients in matters of negotiation and contracts related to industrial property and in subjects such as unfair competition and publicity.

Previously, he worked as an Actuary (Officer) in the Third Criminal Court of Santiago (1997–1998).

Other titles:

Member of the Board of the Chilean Association of Intellectual Property (ACHIPI), Chilean Group of AIPPI.

Memberships:

ACHIPI.

Chilean Bar Association.

Inter-American Association of Industrial Property (ASIPI).

Languages:

Spanish; English; and Portuguese.

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Chapter 9

AnJie Law Firm

China

As to how long it takes proceedings to reach trial from commencement, this depends on the court’s workload, as well as the complexity of the case.

1.3 Can a party be compelled to disclose relevant documents or materials to its adversary either before or after commencing proceedings, and if so, how?

Yes. According to Paragraph 2, Article 64 of the Civil Procedure Law, where the concerned parties and their legal representatives cannot collect evidence on their own for objective reasons, the court shall conduct an investigation and collect evidence. That is, the court may order a party to disclose relevant documents or materials to its adversary. If the party refuses to disclose relevant documents or materials, it shall bear unfavourable legal consequences.However, in current practice, it is not common for the court to apply the above rule. Therefore, any parties concerned should do their best to collect evidence.

1.4 What are the steps each party must take pre-trial? Is any technical evidence produced, and if so, how?

China does not have a so-called discovery pre-trial proceeding. But China has an evidence exchange proceeding, according to which, under the auspices of the court, all parties concerned present their evidence, so that the points at issue can be determined pre-trial. China’s evidence exchange system is different from the U.S.’s discovery proceeding in that it is conducted under the auspices of the court and no party is compelled to present evidence.The plaintiff is required to provide technical analysis or an infringement claim chart, illustrating the patent claims and the corresponding features of the alleged infringing product or method.

1.5 How are arguments and evidence presented at the trial? Can a party change its pleaded arguments before and/or at trial?

The trial mainly includes an investigation period and a debate period. In the investigation period, the court tries to find all relevant facts and the claims of the concerned parties, including presenting evidence. In the debate period, the issues are fixed and the concerned parties make cross-examination and arguments regarding the evidence. In this way, the facts are found by the court.According to the Judicial Interpretations of Applying the Civil Procedure Law released by the Supreme Court, a party can change its pleaded arguments, prior to the end of the debate period.

1 Patent Enforcement

1.1 Before what tribunals can a patent be enforced against an infringer? Is there a choice between tribunals and what would influence a claimant’s choice?

In China, not every court has jurisdiction over patent cases. Jurisdiction over patent cases goes to the intermediate courts at the capital cities of provinces, autonomous regions and municipalities directly under the central government, as well as the intermediate courts designated by the Supreme Court. There are IP tribunals in these courts which handle patent cases, and other tribunals will generally not handle patent cases unless criminal cases about patent passing off are involved. Currently, there are three specialised IP Courts in Beijing, Shanghai and Guangzhou, respectively, and they belong to the intermediate courts.A claimant may make a choice between courts having jurisdiction if there are several places where patent infringement occurs. Such forum shopping is one of the strategies for patent litigation. The claimant’s choice depends on his preference for pro-patentee tendency, home court advantage, etc. For example, the judges in the Beijing IP Court are more experienced than their peers in some courts in western regions, but they have more workload and thus may need a longer time to make court decisions, which will influence a claimant’s choice.

1.2 What has to be done to commence proceedings, what court fees have to be paid and how long does it generally take for proceedings to reach trial from commencement?

Commencement of a patent infringement proceeding is no different from other civil proceedings. For a foreign plaintiff, it needs to hire Chinese lawyers if it has no residence in China. In addition to a suit brief and supporting evidence, a notarised and legalised Power of Attorney (“POA”) signed by a legal representative of the foreign plaintiff, a certificate of identity of the legal representative of the foreign plaintiff, and a copy of business registration for the foreign plaintiff must be filed before commencement of the patent infringement proceeding.A plaintiff shall pay a court fee corresponding to the damages it claims. If no specific damage is concerned, the plaintiff shall pay RMB 500–1,000 per case. If there is a specific amount of damages, the court fee shall be calculated according to a stepped-up payment system as stipulated by the Supreme Court.

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1.10 If declarations are available, can they address (i) non-infringement, and/or (ii) claim coverage over a technical standard or hypothetical activity?

A non-infringement declaratory judgment is available, but a court can only declare whether or not the plaintiff’s act falls within the claim scope. Therefore, it will address non-infringement, but it will not address claim coverage over a technical standard or hypothetical activity since that is irrelevant in the case.

1.11 Can a party be liable for infringement as a secondary (as opposed to primary) infringer? Can a party infringe by supplying part of, but not all of, the infringing product or process?

Yes. Indirect infringements are provided in Article 21 of the Judicial Interpretation of Supreme People’s Court on Patent Infringement Disputes (II), which are similar to the contributory infringement and induced infringement set forth in 35 U.S.C. 271 (c) and (b).Yes. Where a supplier, who clearly knows that a certain product is specially used for implementing a patent, provides, without the authorisation of the patentee, for production or business purposes, the product to an implementer who has already carried out the patent, the supplier shall be liable for contributory infringement.

1.12 Can a party be liable for infringement of a process patent by importing the product when the process is carried on outside the jurisdiction?

It depends on the type of process patent. If the patented process is a process for manufacturing a product, patent protection extends to the product obtained directly by the patented process. That is, a party shall be liable for infringement of the process patent by importing the product, even if the process is carried out outside Chinese jurisdiction. But for other types of process patents, such as detection process, no infringement can be found by a Chinese court if the patented process is carried out outside Chinese jurisdiction.

1.13 Does the scope of protection of a patent claim extend to non-literal equivalents?

Yes. If literal infringement is not found, the Doctrine of Equivalents for patent infringement can be further applied. The Supreme Court has judicial interpretations on infringement under the Doctrine of Equivalents.

1.14 Can a defence of patent invalidity be raised, and if so, how? Are there restrictions on such a defence e.g. where there is a pending opposition?

In China, the court cannot decide the patent validity issue in an infringement case, thus a defence of patent invalidity cannot be raised to the court during an infringement proceeding. An invalidation action shall be filed to the Patent Re-examination Board of the SIPO, no matter whether an infringement case is ongoing. The court might stay the infringement proceeding once the invalidation request is filed.

1.15 Other than lack of novelty and inventive step, what are the grounds for invalidity of a patent?

The grounds for invalidity of a patent include:

1.6 How long does the trial generally last and how long is it before a judgment is made available?

A trial may last half an hour for a simple case or one or two days for a complicated case.According to the Civil Procedure Law, for the first instance case, the judgment shall be made available within six months from the date of case establishment, but a time extension is allowed for special situations. For the second instance case, the judgment shall be made available within three months, but a time extension is also allowed for special situations. Defendants often choose to challenge the patent validity before the Patent Re-examination Board of the SIPO, and thus the court will usually stay the case until the Board renders a validity decision. It generally takes six to 12 months to reach a validity decision by the Board.In practice, it is very common to get the judgment within one year.

1.7 Are judgments made available to the public? If not as a matter of course, can third parties request copies of the judgment?

Judgments are generally made available to the public after they take effect, unless they (1) involve national secrets or personal privacy, (2) involve a juvenile offence or crime, (3) are closed by mediation, or (4) are not suitable for going public online.If not falling within the above four situations, third parties can request copies of the judgment. A vast majority of the judgments are available online.

1.8 Are there specialist judges or hearing officers, and if so, do they have a technical background?

Many, if not most, judges have graduated from law school with no technical background. Even if a judge has a technical background, he only has technical knowledge or sense in a certain field, not in all technical fields.To assist judges to understand technical facts more accurately, technical investigation officers are introduced, as the helpers of judges. In oral hearings of some technically complicated cases at the Supreme Court and the three IP Courts, technical investigation officers played an important role in technical fact-finding.

1.9 What interest must a party have to bring (i) infringement, (ii) revocation, and (iii) declaratory proceedings?

In an infringement lawsuit, the patentee or the exclusive licensee may be the plaintiff, and a non-exclusive licensee with the patentee’s approval can also be a plaintiff.Any individual or entity can file an invalidation petition to request the Patent Re-examination Board of the SIPO to announce a patent invalid. There is no requirement for interest of the petitioner.A warning letter receiver can file a non-infringement declaratory lawsuit if: (1) the right holder sent a warning letter of patent infringement to the receiver; (2) the receiver sent back a written notice urging the right holder to exercise its right of action; or (3) the right holder neither withdraws the warning letter nor files a lawsuit within one month after receiving such written notice or within two months after sending the written notice out.

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Final injunction: A final injunction will generally be granted if the court finds patent infringement, unless public interest or national interest will be affected.

1.19 On what basis are damages or an account of profits assessed?

Article 65 of the Patent Law states how damages are calculated:(1) The amount of damages for patent infringement shall be

determined on the basis of the loss actually suffered by the right holder due to the infringement.

(2) If it is difficult to determine the actual losses, the amount may be determined on the basis of the benefits the infringer has earned due to the infringement.

(3) If it is difficult to determine the right holder’s losses or the infringer’s benefits, the amount may be determined by reference to the appropriate multiple of the amount of the licensing fee of that patent under a licence. The damages shall include reasonable costs incurred for stopping the infringement.

(4) If it is difficult to determine the losses which the right holder has suffered, the benefits which the infringer has earned, or the licensing fee of the patent, the court may award an amount of damages not less than RMB 10,000 and not more than RMB 1,000,000 depending on factors like the type of patent right, the nature and extent of the infringing act.

1.20 How are orders of the court enforced (whether they be for an injunction, an award of damages or for any other relief)?

Once a court order or decision becomes effective, it can be executed, upon request, by the first instance court or the court where the property to be executed is located and which has the same level as the first instance court.

1.21 What other form of relief can be obtained for patent infringement? Would the tribunal consider granting cross-border relief?

According to the Chinese Patent Law, relief for patent infringement only includes ceasing infringement and damage compensation. There are other forms of relief stipulated by the General Principles of the Civil Law, such as apology and elimination of ill effect. However, relief, like apology or elimination of ill effect, has seldom been granted by the court since 2003, as the judges are of the opinion that patent infringement belongs to the torts of property rights rather than personal rights.With the strengthening of IP protection in recent years, relief such as destruction of manufacturing tools or infringing products was granted by some courts.

1.22 How common is settlement of infringement proceedings prior to trial?

The majority of patent infringement cases would be tried by a court. There is no precise data for the settlement rate of the patent infringement proceedings.

1.23 After what period is a claim for patent infringement time-barred?

The prescribed period for litigation is two years, counted from the

(1) patent eligibility;(2) failure to pass the secrecy examination;(3) novelty, inventiveness, or industrial applicability for

inventions or utility models;(4) novelty, inventiveness, or conflict with prior rights for design;(5) insufficient disclosure;(6) indefiniteness;(7) lack of support from specification;(8) brief description and clarity for design;(9) amendment going beyond the original disclosure;(10) lack of essential feature;(11) patent exceptions due to violating Chinese laws and social

morality, or being harmful to public interest, or being completed on the basis of genetic resources, the acquisition or use of which violates Chinese laws and administrative regulations;

(12) un-patentable subject-matters; and (13) double patenting.

1.16 Are infringement proceedings stayed pending resolution of validity in another court or the Patent Office?

It depends.If the patent in suit is a utility model or design patent and an invalidation petition is filed against the patent in suit within the response period, the court will generally stay the infringement proceedings, except for a few situations as listed in judicial interpretations announced in 2001 and amended in 2015 by the Supreme Court. If the patent in suit is an invention patent or a utility model or design patent which had once been maintained valid, the court may not stay the infringement proceedings.In all, the judge has some discretion regarding whether to stay the infringement proceedings.

1.17 What other grounds of defence can be raised in addition to non-infringement or invalidity?

Other grounds of defence include: prior use defence; prior art defence; patent exhaustion defence; temporary transit; scientific research and experiment; and Bolar exception.Legitimate source defence can also be used, according to which the infringer is not liable for damages.Good faith use defence allows the court to grant no injunction if the infringer has paid a reasonable cost. In certain situations, the court may order the defendant to pay the corresponding reasonable fee in view of the balance between the national interest, public interest and patentee’s interest.

1.18 Are (i) preliminary, and (ii) final injunctions available, and if so, on what basis in each case? Is there a requirement for a bond?

Yes, both are available in China.Preliminary injunction: Where the patentee or a party of interest has evidence to prove that another party is infringing or will soon infringe its or his patent right and that it is likely to cause irreparable harm to it or him if such infringing act is not checked or prevented from occurring in time, he or it may, before filing a lawsuit, request the court for adopting measures to stop the relevant acts. When making the preliminary decision, the patentee will be required to provide a guarantee; if a guarantee is not provided, the request shall be rejected.

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The documents of a design patent cannot be amended during invalidation proceedings.

2.3 Are there any constraints upon the amendments that may be made?

Amendments to the invention patent and utility model patent are limited to the claims during invalidation proceedings. During amendments, the title of the subject-matter of a claim cannot be changed, claim scope cannot be broadened, the amendment cannot go beyond the scope of the original disclosure and the addition of technical features, not included in the claims as granted, is generally not allowed.According to the new Patent Examination Guideline which took effect on 1st April 2017, the specific manners of a claims amendment are generally limited to the deletion of a claim, deletion of a technical solution, and further defining a claim and correcting an obvious error. Further defining a claim means the claim can be narrowed by incorporating one or more technical features set forth in other claims.

3 Licensing

3.1 Are there any laws which limit the terms upon which parties may agree a patent licence?

China does not impose much restriction on patent licences. However, cross-border technology transfers such as cross-border patent licences are subject to the China Technology Import and Export Regulations. Some of the requirements under this Regulation are controversial, e.g., mandatory ownership of improvements made by the Chinese licensee, mandatory requirement on indemnity, etc.

3.2 Can a patent be the subject of a compulsory licence, and if so, how are the terms settled and how common is this type of licence?

A patent can be the subject of a compulsory licence under certain circumstances. A compulsory licence belongs to non-exclusive licences and is not sub-licensable.The scope and duration of the compulsory licence shall be decided by the reasons justifying the compulsory licence. When such reasons cease to exist and are unlikely to recur, the State Intellectual Property Office (“SIPO”) shall, upon request by the patentee, make a decision to terminate the compulsory licence after examination.The licensee of a compulsory licence shall pay reasonable royalties to the patentee. The amount of royalties to be paid shall be subject to consultation between the two parties. In the event of failure to reach an agreement between the two parties, the SIPO shall make a ruling. The party not satisfied with the ruling can appeal to the People’s Court.The SIPO has not granted a compulsory licence as of yet.

4 Patent Term Extension

4.1 Can the term of a patent be extended, and if so, (i) on what grounds, and (ii) for how long?

There is no patent term extension in China.

date the patentee or the relevant stakeholder knew or should have known about the infringement act.

1.24 Is there a right of appeal from a first instance judgment, and if so, is it a right to contest all aspects of the judgment?

The party not satisfied with the first instance judgment has the right to appeal to the higher level court within 15 days from the date when the decision is received and 10 days from the date when the ruling is received.The foreign party without residence in Chinese territory has 30 days to appeal to the higher level court from the date when the decision or ruling is received. All aspects of the judgment can be contested.

1.25 What are the typical costs of proceedings to first instance judgment on (i) infringement, and (ii) validity? How much of such costs are recoverable from the losing party?

The official fee for the patent infringement proceeding includes court-official fees, reasonable expenses like notarisation fees, appraisal fees, if any, and attorney fees, etc.The losing party of the patent infringement case shall bear the court-official fees, reasonable expenses, and all or part of the attorney fees. If the plaintiff partially won the infringement case, the court will decide how to pay the court-official fee by both parties.The official fee for requesting patent invalidation in front of the Patent Re-examination Board is RMB 3,000 for invention patents, and RMB 1,500 for utility or design patents, which shall be paid by the patent invalidation petitioner. The party not satisfied with the decision of the Patent Re-examination Board has the right to appeal to the Beijing IP Court, and the judgment of the Beijing IP Court can be further appealed to the Beijing High Court. The official fees for the Beijing IP Court and Beijing High Court for patent administrative litigation cases are both RMB 100, which shall be borne by the losing party.

1.26 For jurisdictions within the European Union: What steps are being taken in your jurisdiction towards ratifying the Agreement on a Unified Patent Court, implementing the Unitary Patent Regulation (EU Regulation No. 1257/2012) and preparing for the unitary patent package? For jurisdictions outside of the European Union: Are there any mutual recognition of judgments arrangements relating to patents, whether formal or informal, that apply in your jurisdiction?

This is not relevant in our jurisdiction.

2 Patent Amendment

2.1 Can a patent be amended ex parte after grant, and if so, how?

There is no ex parte re-examination after grant in China.

2.2 Can a patent be amended in inter partes revocation/invalidity proceedings?

The claims of an invention patent and utility model patent can be amended during invalidation proceedings.

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5.7 What is the term of a patent?

The term for the invention patent is 20 years, and terms for utility model patents and design patents are both 10 years counted from the date of application filing.

6 Border Control Measures

6.1 Is there any mechanism for seizing or preventing the importation of infringing products, and if so, how quickly are such measures resolved?

Yes, there is Customs Intellectual Property protection for seizing or preventing the importation of infringing products.IP owners can submit an application for the impoundment of goods suspected of infringement to customs.Where customs discover imported or exported goods suspected of infringing upon IP that are recorded, it shall notify the IP owner immediately in writing. The IP owner shall submit an application within three working days of the date of delivery of the notification and provide a guarantee in order to impound the goods.After the IP owner has requested customs to impound goods suspected of infringement, customs shall, within 30 working days of the date of impoundment, investigate and confirm whether an infringement act exists or not. If an infringement cannot be found, it shall notify the owner of the IP owner immediately in writing.

7 Antitrust Law and Inequitable Conduct

7.1 Can antitrust law be deployed to prevent relief for patent infringement being granted?

There is no specific article in Antitrust Law regarding relief for patent infringement. However, according to Article 55 of the Antitrust Law, if an operator abuses IP rights to eliminate or prevent competition, antitrust law will apply. Such provisions will apply especially to an SEP (Standard Essential Patent) holder who refuses to license the SEP to an implementer. Article 48 of the Chinese Patent Law is also related to antitrust, which states that the SIPO may grant a compulsory licence if the patentee’s exercise of the patent right is confirmed as a monopoly and its negative impact on competition needs to be eliminated or reduced.

7.2 What limitations are put on patent licensing due to antitrust law?

As stated in question 7.1 above, Article 48 of the Chinese Patent Law is related to a compulsory licence due to a patentee’s monopoly action.

8 Current Developments

8.1 What have been the significant developments in relation to patents in the last year?

A significant development in China in relation to patents in the past year is the amendments to the Patent Examination Guidelines, effective as of 1st April 2017.

5 Patent Prosecution and Opposition

5.1 Are all types of subject matter patentable, and if not, what types are excluded?

Not all subject-matters are patentable. According to Article 25 of the Chinese Patent Law, patent rights shall not be granted for any of the following:(1) scientific discoveries;(2) rules and methods for intellectual activities;(3) methods for the diagnosis or treatment of diseases;(4) animal or plant varieties;(5) substances obtained by means of nuclear transformation; and(6) designs that are mainly used for marking the pattern, colour

or the combination of the two of prints.

5.2 Is there a duty to the Patent Office to disclose prejudicial prior disclosures or documents? If so, what are the consequences of failure to comply with the duty?

The patent applicant has no such duty in China.

5.3 May the grant of a patent by the Patent Office be opposed by a third party, and if so, when can this be done?

Once the patent is granted, anyone can file an invalidation request to revoke the patent. The invalidation request can be filed any time after the grant of a patent.

5.4 Is there a right of appeal from a decision of the Patent Office, and if so, to whom?

Yes. The patent applicant can file a re-examination request to the Patent Re-examination Board if he is not satisfied with the decision made by the patent office. The applicant can appeal to the Beijing IP Court if he is not satisfied with the Board decision within three months upon receipt of the decision.

5.5 How are disputes over entitlement to priority and ownership of the invention resolved?

A dispute over entitlement to priority can be raised during invalidation proceeding, so the novelty or invention step of the patent might be affected.Ownership disputes shall be resolved by the People’s Court.

5.6 Is there a “grace period” in your jurisdiction, and if so, how long is it?

Yes. According to Article 24 of the Chinese Patent Law, within six months before the date of application, an invention for which an application is filed for a patent does not lose its novelty under any of the following circumstances:(1) it is exhibited for the first time at an international exhibition

sponsored or recognised by the Chinese Government; (2) it is published for the first time at a specified academic or

technological conference; and(3) its contents are divulged by others without the consent of the

applicant.

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Damages awarded by the specialised IP Courts have grown aggressively in the past two years. The average damage for patent infringement cases decided by the Beijing IP Court in 2015 was RMB 450,000, which increased to RMB 1,380,000 in 2016. It is also exciting to witness that the Beijing IP Court in a recent case supported the damage award of RMB 50 million in favour of the patentee. Since the Judicial Interpretation of Supreme People’s Court on Patent Infringement Disputes (II) took effect on 1st April 2016, the burden of proof on the plaintiff has been loosened to some degree, i.e., the burden of proof will be shifted to the defendant if the plaintiff has made reasonable efforts to provide evidences of the infringer’s gains from the infringement, which makes a high damage award possible. It will be an apparent trend that more and more NPEs (Non-practising Entities) choose China as a battlefield for patent infringement lawsuits. It is becoming quite common in the Specialised IP Court to employ technical investigators in patent litigation cases for resolving technical issues. They help judges in technical fact-findings and give opinions with the purpose of increasing the quality of judgments. Another movement of IP enforcement in China is the IP Precedents System. In Specialised IP Courts, especially the Beijing IP Court, the judges cite precedents for reasoning in some of the decisions. Although in China, some court opinions are self-contradictory, those decisions issued by the High Courts or Supreme Court will become more influential. All of this shows that China is making great efforts to make court decisions more consistent, transparent, predictable and of a high quality.

AcknowledgmentThe authors would like to thank Jing He and Hui Cao for their assistance in preparing this chapter. Jing He is the founder of AnJie Law Firm and specialises in the Chinese IP and policy sectors (Tel: +86 10 8567 5965 / Email: [email protected]). Hui Cao is a Chinese Attorney at Law in AnJie Law Firm’s IP practice team (Tel: +86 10 8567 5945 / Email: [email protected]).

The new Guidelines provide more possibilities to grant patent applications related to business methods and software, principles regarding data supplementation for pharmaceutical patent applications, and new rules regarding claim amendments in invalidation procedures, etc.

8.2 Are there any significant developments expected in the next year?

It is expected that the fourth amendment of the Patent Law will be issued in the coming year.The new Patent Law includes the following main amendments: strengthening the administrative enforcement of patents; partial design becoming an eligible subject-matter for design patents; the design patent term extended to 15 years; increasing statutory compensation and punitive damages for wilful infringement; clarifying indirect infringement liability; and specifying SEP holders’ obligations during the standardisation formulation process.

8.3 Are there any general practice or enforcement trends that have become apparent in your jurisdiction over the last year or so?

The number of patent filings is increasing rapidly with the filing of invention patent applications close to 1.34 million in 2016. It is expected that the number of patent filings will increase steadily. China continues to strengthen IP enforcement. Specialised IP Courts were established in Beijing, Shanghai and Guangzhou in late 2014, which is a milestone in improving China’s IP protection. China has allocated an additional four cities (Suzhou, Nanjing, Wuhan and Chengdu) for specialised IP Tribunals focusing on IP litigations with cross-regional jurisdictions over the entire province or multiple cities within that province. Such specialised Tribunals have more experienced judges. These developments show that China intends to centralise jurisdiction over patent and other technology-related cases, and improve the quality, efficiency and consistency of IP adjudications.

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Steve SongAnJie Law Firm 19/F, Tower D1Liangmaqiao Diplomatic Office BuildingNo. 19 Dongfangdonglu, Chaoyang DistrictBeijing 100600China

Tel: +86 10 8567 2982Email: [email protected]: www.anjielaw.com

Ying WangAnJie Law Firm 19/F, Tower D1Liangmaqiao Diplomatic Office BuildingNo. 19 Dongfangdonglu, Chaoyang DistrictBeijing 100600China

Tel: +86 10 8567 2952Email: [email protected]: www.anjielaw.com

Steve Song is a Chinese Patent Attorney and Attorney at Law with more than 10 years of experience, focusing his practice on patent law relating to electronics and mechanical arts, including patent drafting, prosecution, invalidation, litigation and counselling. Mr. Song has insightful research on many issues in the theory and cases of Chinese patent law, and has been invited as a special expert to research projects and seminars of the Beijing High Court, SIPO, and Beijing Intellectual Property Office. He has authored more than 30 published articles on Managing Intellectual Property, Patent Law Research, China Patents and Trademarks, China Inventions and Patents, etc.

AnJie is a general practice law firm with outstanding performance in the areas of Intellectual Property, Antitrust, Anti-unfair Competition, etc. The IP attorneys of AnJie have a great track record in developing top-tier legal practices – from patent prosecution and litigation, brand enforcement, technology transfer, trademarks litigation, trade secret protection to intellectual property strategy formulation. Some IP litigation cases handled by our attorneys have been selected as annual cases by the Supreme People’s Court and the Beijing High Court.

The service quality of AnJie’s IP team has been highly recognised by customers and professionals. It has been rated as the leading intellectual property law firm by Asian Legal Business, Rising Star by Managing Intellectual Property in 2014–2016, Intellectual Property Law Firm of the Year by IAM Patent 1000 in 2015 and 2016, World’s Leading Trademark Law Firm by World Trademark Review 1000 in 2015–2017, and Top Intellectual Property Law Firm by The Legal 500 in 2017. The main partners were named as Band One IP practitioners by Chambers in 2015–2017.

Ying Wang is a Chinese Patent Attorney and Attorney at Law. Ms. Ying Wang started her legal career as a patent attorney in 2002 in a Chinese IP firm and later worked in the patent department of a multi-national company for nine years before joining AnJie Law firm. Ms. Wang’s practice covers patent prosecutions in China and overseas, FTO analysis, licensing, as well as patent invalidation and litigation. She has good knowledge and working experience of patent matters in the U.S., Europe, India and some other countries, and can help clients to formulate appropriate filing strategy globally. Ms. Wang had participated in plenty of R&D projects, accumulating rich experiences in IP investigation for a project, design around and IP risk clearance. She also helps clients to establish an effective enterprise IP system, formulate IP strategy, manage IP portfolio, and advises clients on research collaboration and technology transfer issues.

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Chapter 10

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France

with an amicable outcome before delivering a complaint (decree n° 2015-282 of March 11, 2015). Once the case is filed, the plaintiff must show relevant pieces of evidence in the pre-trial preliminary proceedings and the defendant must file a response. In certain cases, the court may appoint an expert. During pre-trial proceedings, parties may ask the judge to order the communication of relevant pieces of evidence, as well as to grant provisional compensation. No court fees have to be paid to commence proceedings. The only fees a party has to pay are the attorney fees for drafting the complaint, and bailiff fees to serve it. In straightforward patent infringement cases, pre-trial proceedings last from 12–18 months.

1.3 Can a party be compelled to disclose relevant documents or materials to its adversary either before or after commencing proceedings, and if so, how?

While there are no discovery proceedings under French law, based under general civil law, a pre-trial judge may order the production of documents (Article 770 Code of civil procedure). More specifically, since the implementation of the Directive on the Enforcement of Intellectual Property Rights 2004/48/EC, French law expressly provides a “right of communication” to enable plaintiffs to find out the origin of allegedly infringing goods. These pieces of information may be obtained upon a petition presented to the jurisdiction either before proceedings or during pre-trial proceedings (see question 1.2). Also, the court may order on its own motion, either before or after commencing proceedings, any legally permissible preparatory inquiries (law n°2014-315 of March 11, 2014). Article 43 of the TRIPS Agreement also provides that courts may order the opposing party to disclose evidence if such evidence is necessary to the substantiation of the defendant’s claim. In any case, the jurisdiction will assess whether any lawful impediment such as force majeure, professional secrecy, or business secrecy is legitimate to limit the communication of evidence.

1.4 What are the steps each party must take pre-trial? Is any technical evidence produced, and if so, how?

After filing the complaint, once the defendant is represented, the plaintiff’s lawyer must disclose the evidence pieces to the defendant’s lawyer, who will then respond in writing and disclose relevant evidence pieces. Parties will be allowed to respond to the opponent’s claims or counterclaims. According to standard procedures at the Paris Court, there should be only two briefs from the plaintiff (including the initial complaint) and from the defendant. Also, the defendant is the last one to respond. While the

1 Patent Enforcement

1.1 Before what tribunals can a patent be enforced against an infringer? Is there a choice between tribunals and what would influence a claimant’s choice?

While patent infringements may be both a civil tort and a criminal offence, civil courts judge almost all patent infringement cases because contrary to criminal law cases, civil cases are judged by chambers that are specialised in intellectual property law. In civil cases, plaintiffs, duly represented by lawyers, must ask bailiffs to deliver a fully motivated complaint to defendant(s) and then have the delivered complaint filed in court.For proceedings initiated after November 2, 2009, the Paris Civil Court of First Instance has exclusive jurisdiction. Previously, patent infringement proceedings could be filed before one of the seven First Instance Civil Courts, which had territorial jurisdiction in particular cases. Patent infringement proceedings may be initiated upon a complaint from the patent owner, the exclusive licensee under the conditions set in the Intellectual Property Code (hereafter the IPC), or in case of criminal proceedings, by the public prosecutor or by customs officials.

1.2 What has to be done to commence proceedings, what court fees have to be paid and how long does it generally take for proceedings to reach trial from commencement?

In practice, patent infringement proceedings start with a seizure that may be carried out after an order from the President of the Paris Court. Once the plaintiff discloses relevant pieces of evidence such as the title and any allegedly infringing actions, seizure orders may be immediately granted. Seizures are performed by bailiffs, who perform any judge-authorised investigation, describing or seizing allegedly infringing goods or any document linked to them. Bailiffs can be, if authorised by the court order, assisted by experts (technicians, computer specialists, accountants…) – other than employees of the plaintiff. The Paris Civil Court of Appeal held, in a ruling dated May 26, 2017, RG 15/10204, that a seizure can be carried out without been required the proof or even the commencement of proof of an infringement. Within 31 calendar days or 20 business days from the seizure, the plaintiff must deliver a complaint to the defendant. Unless there is a particular urgency, the plaintiff must try to resolve the dispute

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principal claim by parties who may have an interest in seeing the patent invalidated (e.g. an action initiated by the patent buyer, Paris Appeals Court, October 19, 2005, PIBD 2006-IIIB-47) as long as the interest is not illegitimate (inadmissibility of an invalidity action filed as a retaliation to unlinked unfair competition proceedings (Paris Appeals Court, July 6, 2007, SIDER v. PRONTEX)). Any person, who proves to have a legitimate industrial operation on the territory of a Member State of the European Economic Community, or showing real and effective preparations to that effect, may bring non-infringement declaratory proceedings (Article L615-9 of the IPC).

1.10 If declarations are available, can they address (i) non-infringement, and/or (ii) claim coverage over a technical standard or hypothetical activity?

Declaratory non-infringement proceedings can address non-infringement over a legitimate industrial application on the territory of a Member State of the European Economic Community or over real and effective preparations to that effect (Article L615-9 of the IPC) (see question 1.9).

1.11 Can a party be liable for infringement as a secondary (as opposed to primary) infringer? Can a party infringe by supplying part of, but not all of, the infringing product or process?

Primary infringement is defined in Articles L613-3 (prohibition of manufacturing, use, offering for sale and detention) and L613-4 of the IPC. Specifically, Article L613-4 of the IPC prohibits the supply or offer to supply, on French territory, of the means of implementing, on that territory, the invention with respect to an essential element thereof, where the third party knows that such means are intended for putting the invention into effect. This provision does not apply when the means of implementation are staple commercial articles, except where the third party induces the person supplied to commit acts prohibited by Article L613-3.The Supreme Court, in a ruling dated June 8, 2017, n°15-293783, held that infringement by supply of means of a patent that covers an invention that consists of a combination of means may result from the supply of a mean relating to an essential element of the combination, when the infringer knows or when circumstances make obvious that this mean is intended for the implementation of this invention, even though it is a constituent element.

1.12 Can a party be liable for infringement of a process patent by importing the product when the process is carried on outside the jurisdiction?

Article L613-3 of the IPC provides that, except with consent by the patent owner, the offering, putting on the market or using the product obtained directly by a process, which is the patent subject matter, or importing or stocking for such purposes, shall be prohibited.

1.13 Does the scope of protection of a patent claim extend to non-literal equivalents?

French case law has acknowledged infringement by equivalents, where a similar function is performed by a different item of the infringing goods (Supreme Court, January 26 1993, PIBD 1996-608-III-175), as well as partial infringement and reproduction of the essential characteristic of the protected system (Supreme Court February 19 1991, PIBD, 1991-503-III-391).

rule about the number of briefs is not generally followed (parties often file three, four or even more briefs), it is quite set that the defendant has to be the last one to respond. In matters involving complex technologies, the court may appoint a technical expert. In any case, the plaintiff must clearly show the infringement.

1.5 How are arguments and evidence presented at the trial? Can a party change its pleaded arguments before and/or at trial?

In regular civil proceedings, only written submissions and pieces of evidence correctly presented during the pre-trial proceedings are admissible, which can then be orally presented by each party’s attorney. Like criminal law proceedings, preliminary injunction proceedings are oral; nonetheless, judges will carefully consider written submissions, which must, in civil proceedings, comply with the format set by the Code of civil procedure. During pre-trial proceedings, parties may exchange their written submissions a couple of times in accordance with the calendar set by the judge in charge of the case. During these pre-trial proceedings, parties may add or abandon new means of defence, arguments, or evidence pieces. Also, parties may withdraw their claims at any time.

1.6 How long does the trial generally last and how long is it before a judgment is made available?

Usually, patent infringement trials last from a couple of hours to half a day. The ruling is made available a few weeks later.

1.7 Are judgments made available to the public? If not as a matter of course, can third parties request copies of the judgment?

Every person over 18 can ask for copy of a Court ruling at the Court Registry. Most patent cases are electronically accessible from the Industrial Property Office website: http://base-jurisprudence.inpi.fr/cindocwebjsp/.The jurisdiction can also order, if it has been requested by one of the parties, the decision to be published online or in paper publications. (L615-7-1 of the IPC.)

1.8 Are there specialist judges or hearing officers, and if so, do they have a technical background?

In France, the third chamber of the Paris Court of First Instance, composed of a total of 12 judges divided into four sections, specialises in patent cases and has exclusive jurisdiction in France for patent cases. The fifth pole of the Paris Appeals Court, composed of six judges divided into two chambers, specialises in patents. These judges do not have a technical background.

1.9 What interest must a party have to bring (i) infringement, (ii) revocation, and (iii) declaratory proceedings?

According to general civil law, plaintiffs must have a personal, legitimate interest to bring proceedings. For infringement cases, as a matter of admissibility, proceedings may be initiated by the patent owner or by the beneficiary of an exclusive licence (except as otherwise stipulated in the licensing contract) if the patent owner gives notice of not instituting such proceedings. Revocation proceedings may take place as a counterclaim or as a

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The court may require a bond based on its sovereign appreciation of the case. Such requirement is not automatic.

1.19 On what basis are damages or an account of profits assessed?

As a matter of principle, damages tend to repair the damage resulting from the infringement. Their assessment will determine whether the plaintiff is entitled to lost sales or to a “licence fee”, depending on whether the patent is used. In any case, upon the plaintiff’s request, the jurisdiction may allocate a lump sum, which shall be no less than the royalty fee the infringer would have paid if he had been authorised to do so (Article L615-7 of the IPC). Furthermore, when assessing the damages, parties and jurisdictions must distinguish between the negative economic consequences to the patentee, the moral damage to the latter, and the profits made by the infringer (law n°2014-315 of March 11, 2014). The Paris Civil Court of First Instance, on May 18, 2017, RG 11/16313, took into account both the negative consequences to the patentee and the profits made by the infringer but held that the compensation of the suffered damage cannot be calculated by an accumulation of the negative economic consequences and the profits of the infringer, who would be without link with the damage and by nature punitive and not dissuasive.

1.20 How are orders of the court enforced (whether they be for an injunction, an award of damages or for any other relief)?

Once the order is pronounced, its execution depends on its service to the other party(ies) and, in first instance proceedings, on whether it has been ordered with the immediate execution. When that is the case, the beneficiary may ask a bailiff to seize the other party’s assets to recover the allocated damages. Regarding injunctions, should the other party not comply with them, the beneficiary may request to the competent court (either the Court that granted the order or the Execution Court) the liquidation of the penalty and its increase.

1.21 What other form of relief can be obtained for patent infringement? Would the tribunal consider granting cross-border relief?

In a successful infringement action, the patent owner will also most often be granted the publication of the ruling (i.e. in newspapers, magazines, the defendant’s website), and, if appropriate, the recall of the goods, the destruction of infringing goods, or of machinery used to produce them. The CJEU has allowed indirect cross-border relief in Solvay v. Honeywell Companies (case C-616/10) where it admitted, regarding provisional measures, that national courts can grant pan-European preliminary injunctions.

1.22 How common is settlement of infringement proceedings prior to trial?

It is common for both parties to reach a settlement of infringement proceedings prior to trial.

1.23 After what period is a claim for patent infringement time-barred?

Before law n°2014-315 of March 11, 2014, it used to be three years from the last infringement. Now it is five years.

1.14 Can a defence of patent invalidity be raised, and if so, how? Are there restrictions on such a defence e.g. where there is a pending opposition?

Patent validity can be challenged in an enforcement action as a counterclaim or in separate proceedings before the same court. A stay on the proceedings may be requested for good administration of justice or in the circumstances mentioned in question 1.16 hereafter. The patentee may also limit its patent to avoid invalidity according to article L613-25 of the IPC.

1.15 Other than lack of novelty and inventive step, what are the grounds for invalidity of a patent?

Article L613-25 of the IPC provides that a patent may be invalid if:■ its subject matter is not patentable within the terms of the

IPC; ■ it does not disclose the invention sufficiently clearly and

completely enough to be carried out by a person skilled in the art; or

■ its subject matter extends beyond the content of the patent application.

Article 138 of the European Patent Convention (October 5, 1973) contains similar provisions.

1.16 Are infringement proceedings stayed pending resolution of validity in another court or the Patent Office?

Courts may stay the proceedings for good administration of justice (i.e. other proceedings pending) and must stay the proceedings for infringement of a French patent that covers the same invention as a European patent applied for by the same inventor until the French patent ceases to have effect (because the European patent has been granted) or until the date on which the European patent application is refused, withdrawn or the European patent revoked (i.e. Paris Appeals Court June 13, 2013, RG. 13/06235).

1.17 What other grounds of defence can be raised in addition to non-infringement or invalidity?

The theory of “essential facilities” from EU law or exhaustion of rights can be raised. Also, there is the possibility to oppose prior rights of invention possession (Article L613-7 of the IPC). According to the Paris Convention Article 5-ter, the use of patented technology via means of transportation may fall outside the scope of patent law and not constitute patent infringement (see Interphyto v. Chemagro, Paris Court of Appeal, 4th Chamber, December 3, 1985, PIBD 1986-388-III-130).

1.18 Are (i) preliminary, and (ii) final injunctions available, and if so, on what basis in each case? Is there a requirement for a bond?

Preliminary injunctions may be granted on the merits prior to trials (Article L615-3 of the IPC), if the plaintiffs establish that infringement is plausible. Successful plaintiffs are very commonly granted injunctive relief based on the merits. Under French practice, injunctive relief is granted under penalties for every day of the delay or per infringement to the injunction with the benefit of immediate execution (there is no suspension of the injunction even if an appeal is lodged).

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has been said, off the record, that the exact location for the Central Division in Paris has been identified.

2 Patent Amendment

2.1 Can a patent be amended ex parte after grant, and if so, how?

Since the law of August 4, 2008, the patentee may limit patent claims before the French Patent Office (INPI) at any time by filing a request and paying the relevant fees (EUR 260 – reduced fees of EUR 130 for not for profit and SMEs – in July 2017).

2.2 Can a patent be amended in inter partes revocation/invalidity proceedings?

French patent claims are solely amended before the INPI. European patent claims can be amended before the EPO. French and European patents can be totally or partially cancelled by French courts in inter partes invalidity proceedings. Also, as mentioned above, the patentee may amend its claims during the proceedings.

2.3 Are there any constraints upon the amendments that may be made?

Amended claims must be supported by the description and cannot be broader than initial claims.

3 Licensing

3.1 Are there any laws which limit the terms upon which parties may agree a patent licence?

While there are no specific requirements for patent licence terms, licence contracts must be in accordance with competition law. For instance, Article 2 of EU Regulation nº316/2014 on technology transfer agreements provides that the contract shall apply as long as the licensed technology has not expired, lapsed or been declared invalid.

3.2 Can a patent be the subject of a compulsory licence, and if so, how are the terms settled and how common is this type of licence?

While French law provides the possibility of compulsory licences, these licences are extremely rare. A compulsory non-exclusive licence may be requested at the court for patents that have not been used according to Articles L613-11 et seq. of the IPC. Also, the owner of a subsequent patent that cannot be used without the authorisation of the owner of a prior patent may request before the court a licence of the prior patent to the extent necessary for exploiting the patent of which he is holder and in as much as that invention constitutes, with regard to the prior patent, substantial technical progress and is of considerable economic interest. Plant Variety Rights owners may also request a licence. Ex officio, patent licences may also be requested for public health reasons (Articles L613-16 et seq. of the IPC). There is also the possibility of ex officio licences for national defence requirements.

1.24 Is there a right of appeal from a first instance judgment, and if so, is it a right to contest all aspects of the judgment?

An appeal may be filed within one month from the notification of the decision. A two-month extension to this deadline is granted to parties located outside of France. After a formal appeal, the appellant must present its motives within three months. In practice, most appeals cover the right to contest all the aspects of the judgment. Once the appeal is filed, the non-appealing party may also contest the first instance ruling within the appeal proceedings. From September 1, 2017, appeal declarations must specify their scope and be fully substantiated by submissions within a one-month or three-month deadline depending on the type of proceedings. The other party to the appeal must reply within the same deadline.

1.25 What are the typical costs of proceedings to first instance judgment on (i) infringement, and (ii) validity? How much of such costs are recoverable from the losing party?

There are attorney fees for requesting seizure orders, bringing actions, presenting court petitions, pleading cases, and counselling clients. For first instance proceedings, these fees range from EUR 25,000 to EUR 100,000 or more depending on the case.In most cases, there are also fees for patent experts (conseils en propriété industrielle), who will assist the attorney and the bailiff during both the seizure and the infringement proceedings. These fees are from EUR 30,000 to EUR 150,000 or more, depending on the issues raised in the case. There are bailiff fees of at least EUR 2,000 for performing the seizure and EUR 200 for executing the decision (notification, seizures of accounts, etc.). The first instance legal costs range from EUR 200 to EUR 2,000.There may be expert fees if the court appoints an expert. These fees range from EUR 10,000 to more than EUR 100,000 in cases involving complex technologies. As a matter of principle, the losing party has to pay the other party’s legal costs and attorney fees (increasingly, French courts grant a lump sum for attorney fees close to the fees justified by produced invoices). In certain cases, the judge may not order compensation for the fees and expenses to the other party if the judge decides to take into account the losing party’s economic situation or decides such payments would not be fair.

1.26 For jurisdictions within the European Union: What steps are being taken in your jurisdiction towards ratifying the Agreement on a Unified Patent Court, implementing the Unitary Patent Regulation (EU Regulation No. 1257/2012) and preparing for the unitary patent package? For jurisdictions outside of the European Union: Are there any mutual recognition of judgments arrangements relating to patents, whether formal or informal, that apply in your jurisdiction?

France participates in the enhanced cooperation on Unitary Patent Protection, which results in a Unitary Patent. The Agreement on a Unified Patent Court was ratified on March 14, 2014. The Central Division of the Unified Patent Court will sit in Paris and hear cases under the competence of other divisions as well as cases on transporting, textiles paper, fixed constructions, and electricity. It

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patents, also called the INPI. Decisions from the European Patent Office (EPO) may be appealed to the EPO Boards of Appeal. On April 25, 2017, RG 2016/11489, the Paris Appeals Court held in a matter regarding the revocation of a patent for late payment that legitimate excuses for such late payment have to be considered in relation to the patent-holder’s situation as opposed to in relation to the patent-holder’s representative who received notifications from the Office. In such case, the patent may be restored considering that the patent-holder has legitimate excuses.

5.5 How are disputes over entitlement to priority and ownership of the invention resolved?

Article L611-8 of the IPC provides that where an application for the grant of an industrial property title has been made, either for an invention unlawfully taken from an inventor or his successors in title, or in violation of a legal contractual obligation, the injured party may claim ownership of the application or of the title granted (see also European Patent Convention, Article 61). According to the IPC, actions claiming ownership shall be barred after five years from the publication of the grant of the industrial property title. The IPC also says that if the bad faith of the owner of the title at the time the title was granted or acquired can be proved, the time limit shall be five years from the expiry of the title.

5.6 Is there a “grace period” in your jurisdiction, and if so, how long is it?

Apart from the right of priority as set out in the Paris Convention, only in very specific cases will disclosure of an invention not invalidate a patent based on such invention. The relevant provisions are found in Article L611-13 of the IPC and Article 55 of the European Patent Convention.Article L611-13 of the IPC provides that a disclosure of the invention shall not be taken into consideration in the following two cases:1) if it occurred within the six months preceding filing of the

patent application; or2) if the disclosure is the result of publication, after the date of

that filing, of a prior patent application, and if, in either case, it was due directly or indirectly to:a) evident abuse in relation to the applicant or his legal

predecessor; orb) the fact that the applicant or his legal predecessor had

displayed the invention at an official, or officially recognised, international exhibition falling within the terms of the revised Convention on International Exhibitions signed in Paris on November 22, 1928. However, in the latter case, the displaying of the invention must have been declared at the time of filing and the proof furnished within the time limits and under the conditions laid down by regulation.

Article 55 of the European Patent Convention States that: “(1) (…) a disclosure of the invention shall not be taken

into consideration if it occurred no earlier than six months preceding the filing of the European patent application and if it was due to, or in consequence of:(a) an evident abuse in relation to the applicant or his legal

predecessor; or(b) the fact that the applicant or his legal predecessor

has displayed the invention at an official, or officially recognised, international exhibition falling within the terms of the Convention on international exhibitions signed in Paris on 22 November 1928 and last revised on 30 November 1972.

4 Patent Term Extension

4.1 Can the term of a patent be extended, and if so, (i) on what grounds, and (ii) for how long?

While there is no possibility of a patent extension, in practice, an invention may be protected for a longer term in France:■ if a European patent (EP) designating France is filed under

the priority of a French patent (an addition of almost a year of protection); or

■ by requesting supplementary protection certificates in the case of pharmaceutical specialities and plant protection products covered by a marketing authorisation.

5 Patent Prosecution and Opposition

5.1 Are all types of subject matter patentable, and if not, what types are excluded?

Article L611-10 of the IPC expressly states as patentable all new inventions implying an inventive step, and susceptible to industrial application, and that are not regarded as inventions, discoveries, scientific theories and mathematical methods, aesthetic creations, schemes, rules and methods for performing mental acts, playing games or doing business, programs for computers, or presentations of information (Paris Court of First Instance, March 19, 2010, RG 2008/01998: cancellation of a patent covering solely a method of presenting information; see also European Patent Convention, Article 52). These provisions apply only to the extent to which the patent relates to such subject matter. Thus, patents referring to computer programs may be valid (Paris Court of First Instance, November 20, 2007, PIBD-2007-867-III-59, regarding the patentability of a system of couponing including a computer program). More precisely, Article L611-16 et seq. provide that methods for treatment of the human or animal body by surgery or therapy and diagnostic methods are not patentable. However, this rule does not apply to products, in particular substances or compositions, for use in any of these methods. Thus, very commonly, pharmaceutical patents are validated (Paris Court of First Instance July 10, 2010, RG 2008/16206).

5.2 Is there a duty to the Patent Office to disclose prejudicial prior disclosures or documents? If so, what are the consequences of failure to comply with the duty?

No, there is not.

5.3 May the grant of a patent by the Patent Office be opposed by a third party, and if so, when can this be done?

French patents may not be opposed. European patents may be opposed up to nine months after the publication of their granting.

5.4 Is there a right of appeal from a decision of the Patent Office, and if so, to whom?

The Paris Appeals Court has exclusive jurisdiction for appeals regarding decisions from the public administration that delivers

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about by designating that patent and specifying the way in which it has been infringed, and, secondly, after the alleged infringer has expressed its willingness to conclude a licensing agreement on FRAND terms, presented to that infringer a specific, written offer for a licence on such terms, specifying, in particular, the royalty and the way in which it is to be calculated; and

■ where the alleged infringer continues to use the patent in question, the alleged infringer has not diligently responded to that offer, in accordance with recognised commercial practices in the field and in good faith, this being a matter which must be established on the basis of objective factors and which implies, in particular, that there are no delaying tactics.”

Also, the Court held that in such circumstances: “Article 102 TFEU must be interpreted as not prohibiting […] an undertaking in a dominant position and holding a patent essential to a standard established by a standardisation body, which has given an undertaking to the standardisation body to grant licences for that patent on FRAND terms, from bringing an action for infringement against the alleged infringer of its patent and seeking the rendering of accounts in relation to past acts of use of that patent or an award of damages in respect of those acts of use.”

7.2 What limitations are put on patent licensing due to antitrust law?

Limitations are found in the general EU provisions regarding non-discrimination and free movement of goods within the EU, as well as competition law issues from EU treaties. More specific competition rules are found in Regulation nº316/2014, which expressly prohibits pricing restrictions or limiting production (Article 4). In the past year, the European Commission has sent a statement of objections in a case about essential patents involving Samsung that has led to commitments to negotiate and not to seek injunctive relief. In late 2013, the European Commission also imposed fines in a well-publicised case regarding a generic medicine (fentanyl).

8 Current Developments

8.1 What have been the significant developments in relation to patents in the last year?

In patent infringement cases, patentees are allowed more broadly to request patent limitations. On July 7, 2016, ECJ ruled on patent licensing upon a referral from the Paris Appeals Court regarding patent licensing (case C-567/14). The Court held that Article 101 of the TFEU did not preclude “a requirement to pay a royalty for the use of a patented technology for the entire period in which that agreement was in effect, in the event of the revocation or non-infringement of a licenced patent, provided that the licensee was able freely to terminate that agreement by giving reasonable notice”. The Paris Court of First Instance has applied the teachings of this ruling in another matter in a judgment of January 12, 2017, RG 15/09231.The five-year statute of limitation regarding patent invalidity claims has been on the legal radar over the past 12 months. A ruling from the Paris Court of First Instance of March 16, 2017, RG 15/07920, held that the five-year period that bars a patent invalidity action starts at the time where the patent invalidity claimant knew or should have known that a patent may hinder the claimant’s business. In that particular case, the patent invalidity claim was held inadmissible. A couple of months later, on June 8, 2017, in

(2) In the case of paragraph 1(b), paragraph 1 shall apply only if the applicant states, when filing the European patent application, that the invention has been so displayed and files a supporting certificate within the time limit and under the conditions laid down in the Implementing Regulations.”

5.7 What is the term of a patent?

The term of both French and European patents is 20 years from the date of the application.

6 Border Control Measures

6.1 Is there any mechanism for seizing or preventing the importation of infringing products, and if so, how quickly are such measures resolved?

EU Regulation nº608/2013 harmonised and set the conditions for seizures by customs authorities of infringing goods entering the EU. Customs agents may act upon the patentee’s request or during customs control (in which case the patentee has four business days from the notification to present a request). Once goods are seized, the patentee must introduce proceedings to seek whether intellectual property rights are infringed within 10 business days (three business days in case of perishable goods). Then, regular proceedings will follow. These regulations also provide possibilities of destruction of goods by customs in case of consent of the owner of the goods or in case of small consignments. Similar provisions are found in French law regarding goods circulating within the EU.

7 Antitrust Law and Inequitable Conduct

7.1 Can antitrust law be deployed to prevent relief for patent infringement being granted?

EU competition law has established the principle of exhaustion of right that has limited the scope of patent rights and led to Article L613-6 of the IPC. Also, several copyright law cases have generated the “essential facilities” doctrine, limiting intellectual property rights that could be applied to patent cases. We are not aware of rulings on the merits from the Paris courts implementing such theory in patent cases, even if it has been debated in cases we have worked on. Regarding the interim, a pre-trial judge has refused to grant an interlocutory injunction in a case involving essential patents and contractual negotiations between parties considering that a prohibition order may distort contractual negotiations (Paris CFI, 3rd ch. 2nd s. case management order, November 29, 2013, RG 12/14922). In the same way, the European Commission decided in the Motorola case (IP/14/489) that it was abusive for the patent-holder to both seek and to enforce an injunction on the basis of a standard essential patent against a party who had agreed to take a licence and be bound by a determination of Fair and Reasonable and Non-Discriminatory (FRAND) royalties. On July 16, 2015, in Huawei Technologies Co. v. ZTE Corp. (C-170/13), the European Court of Justice interpreted EU competition law provisions regarding patents essential to a standard. The Court interpreted Article 102 TFEU to not prohibit a patent owner from bringing an infringement action against the alleged infringer and obtaining damages and seeking an injunction and the recall of infringing products as long as:■ “prior to bringing that action, the proprietor has, first,

alerted the alleged infringer of the infringement complained

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Catherine MateuArmengaud & Guerlain12, avenue Victor Hugo75116 ParisFrance

Tel: +33 147 540 148Email: [email protected]: www.armengaud-guerlain.com

Catherine Mateu is a partner at Armengaud & Guerlain, and a certified intellectual property specialist lawyer in Paris. She holds a postgraduate degree in French and European Business Law from the Université de Nancy II, an LL.M. in Common Law from the University of East Anglia, a DESS in Industrial Property from the Université de Paris II, and a DEA in Private International Law from the Université de Paris I. She is fluent in French, Spanish, English, and Basque.

Ms. Mateu is an active member of several intellectual property law associations, including the AIPPI and INTA, where she holds several committee leadership positions. She also frequently speaks at various intellectual property conferences.

Her practice serves clients ranging from inventors, non-profit organisations, and local start-ups to multi-national corporations, and focuses on finding timely and cost-effective solutions to a wide array of patent, trademark, design infringement, and licensing matters.

Armengaud & Guerlain, founded in 1993, is a law firm fully specialised in intellectual property (patents, trademarks, designs and models, and copyright) and the related issues of unfair competition, consumer law, advertising rights (particularly comparative advertising), and the Internet. Reflecting its well-recognised expertise, the firm has worked with a wide variety of French and international clients, from artists and inventors to blue-chip companies, governments, and state-owned enterprises. In addition to French, the firm’s daily working languages include English and Spanish.

Armengaud & Guerlain works with a network of foreign colleagues selected for their high level of technical expertise and their use of work methods identical to Armengaud & Guerlain, thereby enabling the firm to treat files simultaneously in several countries. Each file is treated in a collaborative manner. The firm places particular emphasis on maintaining lasting, high-quality relationships with its clients, combining competence and reactivity.

Due to its well-recognised expertise, the firm has been able to appear systematically for decades in rankings of top law firms established by specialised publications WTR, IAM, Who’s Who Legal, The Legal 500, Chambers, Les Décideurs, Managing Intellectual Property and IP Stars.

been borne by a party and not symbolic sums, as it has often been the case before. Under French practice, defendants in patent infringement proceedings are filing more and more counterclaims based on the harm arising from patent infringement claims (Cass. com., February 10, 2015, case 2013/20150).

case 15-21357, the Supreme Court did not quash an appeals court ruling that had held that the statute of limitation had started from the filing of a trademark. The issue of statute of limitation is followed very closely by French IP practitioners, as a couple more rulings are expected this year.

8.2 Are there any significant developments expected in the next year?

The preparation and implementation of both the Unified Patent Court and the Unitary Patent, how the Court Registry will work, and opt-out possibilities are major issues that are closely followed by patent practitioners. The UK’s vote to leave the EU will have a significant impact on the upcoming Unified Patent Court and the Unitary Patent, given that the UPC Agreement provides it will enter into force once ratified by the UK, as well as by France and Germany. Practitioners also have their eyes on German ratification of the same and the proceedings initiated before the German Supreme Court, where it is claimed that the Unitary Patent and Unitary Patent Court violates German law.

8.3 Are there any general practice or enforcement trends that have become apparent in your jurisdiction over the last year or so?

Since the implementation of the enforcement directive, courts are more inclined to award higher damages and legal fees based on produced invoices. It is also quite common for courts to order the recall of goods (Paris Court of First Instance, March 4, 2009, RG 2007/2589). Also, the recent case law of the Parisian courts shows judges award legal fees increasingly often in relation to the real costs that have

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available which help to establish the suspected infringement before and after commencing an action on the merits. Before action, the patentee can request the issuance of an inspection order in ex parte summary proceedings, which compels the alleged infringer to allow the patentee’s counsel and a court-appointed expert to inspect the contested embodiment. This instrument is particularly useful in the case of suspected infringement of a patent regarding a manufacturing method and/or software implemented inventions. The patentee has to show that (i) there is a sufficient likelihood of infringement of the patent, (ii) he cannot obtain the required information by other means (e.g., a test purchase), and (iii) the inspection is proportionate. The result of this inspection procedure is a technical report rendered by a court-appointed expert which supports (or does not support) a finding of infringement and which can be used in an action on the merits as evidence of infringement. This expert report can help to settle a case without a full-blown patent litigation. After commencement of proceedings, the court can order a party upon request by the other party to produce documents or materials which are relevant for the issues at dispute and in its possession, and for which the information contained therein is not otherwise accessible to the other party.

1.4 What are the steps each party must take pre-trial? Is any technical evidence produced, and if so, how?

Prior to trial, as a rule, four comprehensive submissions will be filed (statement of claim, statement of defence, rejoinder and counter-rejoinder) which are the basis on which the court forms its preliminary opinion and which will, in turn, be the basis for the discussions during trial. Technical evidence can be produced by means of a technical analysis or a technical expert opinion. However, prior to trial, such evidence is, as a rule, not produced on the basis of a court order, but it is up to either party whether it substantiates its position by submitting evidence.

1.5 How are arguments and evidence presented at the trial? Can a party change its pleaded arguments before and/or at trial?

The Presiding Judge presents a summary of the facts of the case and identifies the issues which the court would like to have discussed during the trial. Depending on court and case, the Presiding Judge will also present the preliminary opinion of the court regarding claim construction and other issues addressed in the parties’ written submissions. Then there is a first round of pleadings, by means of which each party presents its arguments, preferably by addressing the specific issues raised by the court. In a second round

1 Patent Enforcement

1.1 Before what tribunals can a patent be enforced against an infringer? Is there a choice between tribunals and what would influence a claimant’s choice?

A patent can be enforced in one of 12 district courts (Landgerichte) which have chambers specialised in patent matters. The plaintiff has a choice of forum if (as usual) the infringement is taking place nationwide (e.g., advertisement on a website). The decisive factors are differences in the speed of the proceedings, quality and predictability of decisions, as well as differences in the views of the courts regarding specific legal questions. With a view to the aforementioned factors, most plaintiffs choose the courts in Düsseldorf or Mannheim.

1.2 What has to be done to commence proceedings, what court fees have to be paid and how long does it generally take for proceedings to reach trial from commencement?

To commence proceedings, the plaintiff has to (i) file the statement of claims, and (ii) make an advance payment of the court fees. The court will then arrange for service of the statement of claims on the defendant(s). The statement of claims comprises not only the motions for relief but also a substantiation of the asserted claims, which includes claim construction and the infringement theory, including the facts and evidence on which it is based. The amount of court fees depends on the (fictitious) value of the matter in dispute, the latter of which is to be determined by the court on the basis of the suggestions by the parties. A common value for a patent matter is 1 million euros, which triggers court fees in the amount of 16,008 euros (a value of 5 million euros would trigger court fees in the amount of 59,208 euros). Depending on the court seized of the matter, it takes, as a rule, between six (Mannheim) and 12 months (Düsseldorf/Munich) to reach the main trial from the date of filing of the action.

1.3 Can a party be compelled to disclose relevant documents or materials to its adversary either before or after commencing proceedings, and if so, how?

While the claimant, as a rule, has to procure the relevant technical information to establish patent infringement, e.g. by means of a test purchase and technical analysis, by itself, instruments are

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1.10 If declarations are available, can they address (i) non-infringement, and/or (ii) claim coverage over a technical standard or hypothetical activity?

Declaratory relief actions can address non-infringement but not hypothetical activities. A declaratory judgment can be obtained regarding claim coverage over a technical standard if a third party claims that the use of a technical standard does not make use of a patent and a regular action for patent infringement would not be available against such third party.

1.11 Can a party be liable for infringement as a secondary (as opposed to primary) infringer? Can a party infringe by supplying part of, but not all of, the infringing product or process?

Besides the primary infringer, a party can be held liable for (i) assisting, (ii) inducing, or (iii) otherwise causing the infringement by the primary infringer. Also, a party can be held liable for indirect (“contributory”) infringement as a result of supplying within Germany parts relating to an essential element of the patented invention for exploiting the invention, provided that the supplier knows, or it is obvious from the circumstances, that such means are suitable, and intended by the customer, to be put to a use that would infringe the patent in Germany.

1.12 Can a party be liable for infringement of a process patent by importing the product when the process is carried on outside the jurisdiction?

In the case of a process patent, infringing acts comprise: (i) the use of the method (also if such use takes place partly abroad and partly within Germany); (ii) the offering for use in Germany, if the offering party is aware that it is obvious that such use is prohibited without the authorisation of the patent owner; or (iii) the import and sale of any direct products obtained by application of the protected process, even if the production takes place abroad.

1.13 Does the scope of protection of a patent claim extend to non-literal equivalents?

A variant is a protected equivalent of the patented invention, if: (i) it solves the problem underlying the invention with modified means which objectively have the same effect as the invention; (ii) a skilled person is able by means of his general technical knowledge to find, without inventive effort, the modified means as having the same effect; and (iii) the considerations to be applied by the skilled person in this regard must be so closely oriented to the essence of the technical teaching described in the patent claim that the person skilled in the art considers the variant with its modified means as equivalent to the solution provided by the invention as defined in the claim. The prior art imposes a limitation on the application of the doctrine of equivalents, i.e. embodiments which are not an invention over the prior art relevant to the patent are excluded from the scope of protection.

1.14 Can a defence of patent invalidity be raised, and if so, how? Are there restrictions on such a defence e.g. where there is a pending opposition?

The defence of patent invalidity can be raised in the infringement proceedings in order to obtain a stay of the infringement proceedings pending the outcome of the separate invalidity proceedings (i.e.,

of pleadings, each party can comment on the other party’s pleading. The court may provide guidance for the discussion by asking specific questions. In the course of the respective oral pleadings, each party can refer to and present the evidence (samples, technical reports and other documents) which has been submitted prior to trial. Legal arguments (e.g. claim construction) can be changed at any time during the proceedings, even at trial. The facts which are the basis of the pleaded arguments can be changed prior to trial but, as a rule, no later than one week prior to trial. If the court considers it necessary to take evidence (which happens in about 10 to 15 per cent of all infringement cases) the court will issue a corresponding order after the trial. As a rule, evidence will be taken in the form of a technical report by a court-appointed expert and, in rare cases, by interrogation of witnesses. The court will schedule a date for continuation of the trial.

1.6 How long does the trial generally last and how long is it before a judgment is made available?

As a rule, there is a one-day trial which lasts a few hours. As a rule, the judgment is normally announced about four weeks after trial.

1.7 Are judgments made available to the public? If not as a matter of course, can third parties request copies of the judgment?

Except for those of the Federal Court of Justice, judgments are not made available to the public as a matter of course. Instead, it is in the discretion of the courts which judgments are to be published (e.g. via internet databases). Judgments are only published as anonymised versions and, as a rule, the patent number is partly redacted. Third parties can request copies of a specific judgment from a court, provided that they know the docket number of the judgment, which has to be indicated in the request.

1.8 Are there specialist judges or hearing officers, and if so, do they have a technical background?

As explained in question 1.1, there are specialised chambers for patent infringement cases. As a rule, these specialist judges do not have a technical background, but due to the constant exposure to a high number of cases (for instance, the Düsseldorf District Court hears about 500 to 600 new cases per year) these judges have a good grasp and understanding of technical issues. Invalidity proceedings are handled by the Federal Patent Court, which is a specialised court whose nullity chambers consist of judges having a technical background and legally trained judges. The technical judges are selected based on the technology in dispute.

1.9 What interest must a party have to bring (i) infringement, (ii) revocation, and (iii) declaratory proceedings?

As a rule, a party does not need to have a particular interest to bring an infringement action or a revocation action. As regards revocation, the plaintiff only has to demonstrate a legitimate interest, e.g. that it is facing damage claims by the patentee, if the patent to be challenged has already expired. For declaratory proceedings, the plaintiff has to show that there is a threat of claims under the patent in dispute, e.g. the patentee has sent a warning letter (as opposed to a simple authorisation request, which is not sufficient).

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have to be initiated, which result in a fine or imprisonment imposed on the infringer.

1.21 What other form of relief can be obtained for patent infringement? Would the tribunal consider granting cross-border relief?

In addition to an injunction and damages, the patentee can obtain rendering of accounts (including disclosure of sales, costs, profits as well as names and addresses of suppliers and customers), destruction of infringing goods, recall and removal from the channels of distribution as well as publication of the judgment. While relief is generally limited to acts within, or directed to, Germany, a party domiciled in Germany can, in principle, also be sued in a German court for infringement of a French or UK patent.

1.22 How common is settlement of infringement proceedings prior to trial?

Settlements are more common subsequent to a trial.

1.23 After what period is a claim for patent infringement time-barred?

The regular period of the statute of limitations is three years from the end of the year in which the patentee became aware of the infringing acts. If the patentee does not become aware of the infringing acts, the statutory limitation period is 10 years starting from the date on which the patentee first incurred damages due to the infringing act. The absolute limitation period, i.e. without knowledge of the infringement and without damages being incurred, is 30 years starting from the date when the first infringing acts took place.

1.24 Is there a right of appeal from a first instance judgment, and if so, is it a right to contest all aspects of the judgment?

A first instance judgment can be challenged with respect to all aspects on the grounds that the court violated the substantive and/or procedural laws. The facts established by the court can be contested to the extent that they are wrong or incomplete; new facts can be submitted in the appeal proceedings if specific requirements are met.

1.25 What are the typical costs of proceedings to first instance judgment on (i) infringement, and (ii) validity? How much of such costs are recoverable from the losing party?

Costs depend on the value of the matter in dispute and can vary greatly. On the basis of a value of the matter in dispute of 1 million euros (which is common for an average patent case), the statutory fees and costs of the first instance infringement proceeding and of the separate first instance nullity proceeding would be in the range of 140,000 euros in total. The statutory costs are recoverable to the full extent. The actual costs are, as a rule, higher since most law firms specialising in patent litigation charge hourly rates, which in sum would be higher than the statutory attorney fees.

opposition or nullity action). The defence can be based on a pending opposition or a pending nullity action.

1.15 Other than lack of novelty and inventive step, what are the grounds for invalidity of a patent?

Other grounds for invalidity are insufficiency of disclosure, added subject matter, inadmissible extension, usurpation, lack of industrial applicability and excluded subject matter.

1.16 Are infringement proceedings stayed pending resolution of validity in another court or the Patent Office?

If the requirements for staying the proceedings are met (as a rule, novelty-destroying prior art – not already taken into consideration during examination of the patent – has to be presented), the infringement proceedings will be stayed.

1.17 What other grounds of defence can be raised in addition to non-infringement or invalidity?

The main other grounds of defence include: right of use (e.g., under a licence); right of prior use; exhaustion of patent right; antitrust (FRAND) defence; lack of standing to sue; unlawful withdrawal; statute of limitation; forfeiture; and experimental privilege.

1.18 Are (i) preliminary, and (ii) final injunctions available, and if so, on what basis in each case? Is there a requirement for a bond?

A permanent injunction is the automatic remedy if the patent is found to be infringed. If the judgment is not final/legally binding (due to an appeal), the injunction can be enforced by providing a bank guarantee or a bond. Preliminary injunctions are available if (i) infringement can be readily established, (ii) the patentee acted swiftly upon knowledge of the infringement (“urgency” requirement), (iii) the validity of the patent has been confirmed in adversarial invalidity proceedings, and (iv) the balance of hardships militates in favour of the patentee. Less strict requirements for preliminary injunctions apply in cases of clear patent infringement by a generics company, or where the remaining lifetime of the patent is so short that an action on the merits would be completed only after expiry of the patent. The execution of the preliminary injunction can be made dependent on the provision of security.

1.19 On what basis are damages or an account of profits assessed?

Damages or an account of profits are determined in separate court proceedings on the basis of a rendering of accounts by the alleged infringer. The patentee can choose among three options for calculating its monetary remedy: (i) a reasonable royalty on infringer’s sales; (ii) the surrender of a share of the infringer’s profits; or (iii) lost profits.

1.20 How are orders of the court enforced (whether they be for an injunction, an award of damages or for any other relief)?

Orders of the court are to be enforced by judicial execution. In the case of a violation of an enforced court order, penalty proceedings

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4 Patent Term Extension

4.1 Can the term of a patent be extended, and if so, (i) on what grounds, and (ii) for how long?

The term of a patent on an active ingredient, or mixture of active ingredients, of a medicinal or plant protection product, can be extended by means of a supplementary protection certificate (SPC). The SPC term corresponds to the period necessary to obtain the marketing authorisation. While the maximum lifetime, as a rule, is five years, a six-month additional extension can be available if the SPC relates to a paediatric medicine. An SPC can be obtained by application to the German patent office within six months of the grant of the first marketing authorisation for Germany for the active ingredient(s) in question. An SPC has the effect of extending the term of the patent in respect of the particular active ingredient only (or mixture of active ingredients) for which the SPC is granted.

5 Patent Prosecution and Opposition

5.1 Are all types of subject matter patentable, and if not, what types are excluded?

Subject matter which is excluded from patentability is as follows: (i) schemes, rules and methods for doing business, performing mental acts or playing games; (ii) programs for computers; (iii) presentation of information; (iv) methods for treatment of the human or animal body by surgery or therapy and diagnostic methods (except for substances or compositions for use in any of these methods); (v) plant or animal varieties or essentially biological processes for the production of plants or animals, except for microbiological processes or the products thereof; (vi) inventions the publication or exploitation of which would be contrary to public policy or morality; (vii) discoveries, scientific theories and mathematical methods; and (viii) aesthetic creations.

5.2 Is there a duty to the Patent Office to disclose prejudicial prior disclosures or documents? If so, what are the consequences of failure to comply with the duty?

A respective duty does not exist.

5.3 May the grant of a patent by the Patent Office be opposed by a third party, and if so, when can this be done?

A third party can file an opposition within nine months of the date of publication of the grant of the patent.

5.4 Is there a right of appeal from a decision of the Patent Office, and if so, to whom?

Decisions of the Patent Office can be appealed to the Federal Patent Court.

5.5 How are disputes over entitlement to priority and ownership of the invention resolved?

A dispute over entitlement to priority will occur in invalidity proceedings and will be resolved as part of the decision on validity of the patent in dispute. A dispute over ownership of an invention is

1.26 For jurisdictions within the European Union: What steps are being taken in your jurisdiction towards ratifying the Agreement on a Unified Patent Court, implementing the Unitary Patent Regulation (EU Regulation No. 1257/2012) and preparing for the unitary patent package? For jurisdictions outside of the European Union: Are there any mutual recognition of judgments arrangements relating to patents, whether formal or informal, that apply in your jurisdiction?

The legislative instruments required for ratification have passed the German Parliament. Only the certification by the Federal President is missing, which has been suspended following a request by the Federal Constitutional Court.

2 Patent Amendment

2.1 Can a patent be amended ex parte after grant, and if so, how?

A patent can be amended, i.e. limited, with effect ex tunc upon the patentee’s request by means of an ex parte limitation proceeding to be filed with the German patent office, or – in case of a European patent – by means of limitation proceedings to be filed with the European Patent Office.

2.2 Can a patent be amended in inter partes revocation/invalidity proceedings?

A patent can be amended, i.e. defended in a limited version, in inter partes invalidity proceedings (i.e. opposition in the European or German patent office or in a nullity action in the Federal Patent Court).

2.3 Are there any constraints upon the amendments that may be made?

The amendment: (i) has to be (x) a limitation with respect to the claims as granted, (y) clear, as well as (z) supported by the patent specification; and (ii) must not add subject matter beyond the application as filed.

3 Licensing

3.1 Are there any laws which limit the terms upon which parties may agree a patent licence?

The main source of limitations is European and German antitrust laws.

3.2 Can a patent be the subject of a compulsory licence, and if so, how are the terms settled and how common is this type of licence?

Compulsory (non-exclusive) licences are awarded by means of a judgment of the Federal Patent Court in inter partes proceedings upon request by the party seeking the licence. Scope and duration are determined by the court and are dependent on the requirements of the public interest. In urgent cases, a compulsory licence can be awarded by means of summary proceedings. Compulsory licences are very rare.

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7.2 What limitations are put on patent licensing due to antitrust law?

Article 101 of the Treaty on the Functioning of the European Union (TFEU) and the corresponding section 1 of the German Act against Restraints of Competition (Gesetz gegen Wettbewerbsbeschränkungen, GWB) prohibit patent licensing that results in a restriction of competition (e.g. by extending the temporal, territorial and material scope of a patent or by price fixing or downstream market foreclosure), unless the critical terms can satisfy the individual exemption criteria of article 101(3) or benefit from a block exemption. The European Commission has issued the technology transfer block exemption regulation (TTBER) and accompanying Guidelines which provide guidance with respect to the assessment of licensing terms. Furthermore, Article 102 TFEU and the corresponding sections 19 and 20 GWB prohibit (i) the refusal of a licence, (ii) unfair royalties, and (iii) other anti-competitive terms, in the case where the patentee holds a dominant position in the relevant market.

8 Current Developments

8.1 What have been the significant developments in relation to patents in the last year?

German courts constantly generate a growing body of elaborated case law dealing with all sorts of issues and questions surrounding infringement and validity of patents. Particularly noteworthy is that, since 2016, German courts have addressed multiple questions regarding the requirements of FRAND licensing in case of standard essential patents which the CJEU left unresolved in its Huawei decision (Case C-170/13).

8.2 Are there any significant developments expected in the next year?

The most significant development expected for 2018 is the launch of the Unitary Patent System in Europe.

8.3 Are there any general practice or enforcement trends that have become apparent in your jurisdiction over the last year or so?

Patent litigation brought by non-practising entities is still on the rise in Germany, which concerns not only the electronics industries but also automotive and medical devices. Notably, there is also an increase in preliminary injunction cases as well as a revival of the “Italian torpedo”.

to be resolved by means of an action to be brought in the competent district court. In case the patent applicant or patentee has gathered knowledge of the invention from documents or other information of the inventor and has filed the patent application without the consent of the inventor, the party infringed by such usurpation may require the right to the grant of the patent (in case of a pending patent application) to be surrendered to it, or the patent (in case of a granted patent) to be transferred to it. In case of a granted patent, such action has to be filed within two years after publication of the grant of the patent, unless (i) the patentee did not act in good faith in obtaining the patent, or (ii) the infringed party has filed an opposition on the grounds of usurpation (in which case the period expires one year after the final conclusion of the opposition proceedings).

5.6 Is there a “grace period” in your jurisdiction, and if so, how long is it?

There is no “grace period” with respect to patents, but a six-month grace period applies in case of utility models.

5.7 What is the term of a patent?

The term is 20 years from the date of application (and 10 years in case of a utility model).

6 Border Control Measures

6.1 Is there any mechanism for seizing or preventing the importation of infringing products, and if so, how quickly are such measures resolved?

European or national customs seizure proceedings are available. In either case, the measure can be resolved by means of destruction or release of the goods within about (or even less than) one month of receipt of the notice regarding the detention. In the absence of such destruction or release upon short notice, customs keeps the goods in custody until a final and legally binding judgment, after which it releases or destroys the products. In case of a European customs seizure, it is possible to provide a bond to customs which covers the patentee’s potential damages in order to have the goods released. In case of a bond, the patentee can prevent customs from releasing the goods only by obtaining a preliminary injunction ordering the goods not to be released.

7 Antitrust Law and Inequitable Conduct

7.1 Can antitrust law be deployed to prevent relief for patent infringement being granted?

In case of assertion of standard essential patents (SEP), the alleged infringer can prevent the issuance of an injunction if he acts fully in line with the requirements set forth by the Court of Justice of the European Union (CJEU) in its Huawei decision (Case C-170/13) regarding FRAND licensing. It is not possible to avoid damages.

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Dr. Matthias SonntagGleiss LutzDreischeibenhaus 140211 DüsseldorfGermany

Tel: +49 211 54061 322Email: [email protected]: www.gleisslutz.com

Dr. Herwig LuxGleiss LutzLautenschlagerstr. 2170173 StuttgartGermany

Tel: +49 711 8997 322Email: [email protected]: www.gleisslutz.com

Gleiss Lutz is one of Germany’s leading full-service law firms with over 300 lawyers. Founded in 1949, the firm has a long-standing tradition of strong IP practice. Patent litigation is the main pillar of its IP group, consisting of 25 dedicated IP lawyers. The patent team represents plaintiffs and defendants in infringement and invalidity proceedings in all competent German courts (at trial and appellate level) as well as in domestic and international arbitration proceedings, customs actions and inspection and seizure of evidence proceedings. Co-authoring a legal handbook on the proceedings in the Unified Patent Court (UPC) and having offices at (or near) all German chambers of the UPC, the Gleiss Lutz patent team is well suited to represent clients in the UPC. The team also provides freedom-to-operate analyses, strategic counselling, technology transactions, licensing and R&D collaborations. While electronics, pharmaceuticals and life sciences are its particular strengths, Gleiss Lutz’s patent team has worked across all major technical fields. Its lawyers have been involved in a number of landmark cases.

Matthias Sonntag is a Partner of Gleiss Lutz. Focusing on patent litigation for more than 15 years, Matthias has pleaded a large number of cases involving patents from a wide variety of technical fields, including electronics, telecommunications, pharmaceuticals, medical devices, chemicals and mechanics, in the relevant German courts, including the Federal Patent Court and the Federal Court of Justice. Matthias is a Bar-certified attorney for IP law. Prior to admission to the Bar, he gathered substantial technical expertise as a member of an interdisciplinary research alliance on IT security and data encryption at the Institute of Information, Telecommunications and Media Law of the University of Munster. Matthias is co-authoring a legal handbook on litigation in the Unified Patent Court (to be published) and is co-author of publications including the English-language guide Intellectual Property Law in Germany and Litigation Standard Form Book for Industrial Property Protection, Copyright and Media Law.

Herwig Lux is a Counsel at Gleiss Lutz. Besides his focus on transactional and strategic advisory work with a particular understanding of patents, he is active in patent litigation and has represented clients in various technical fields, including mechanics, navigation, chemistry, automotive and consumer electronics. In his non-contentious practice, Herwig focuses on complex licensing and other technology-related transactions such as R&D and other cooperation agreements, both between commercial entities and academia, or with individuals such as inventors. His experience ranges from representing major pharmaceutical companies in their cross-border licensing of worldwide patent portfolios to advising technology companies on projects relating to the development and marketing of disruptive technologies. Holding a law degree and a doctorate from Heidelberg University, Herwig has published multiple articles and papers and is a frequent speaker on IP topics. He is also co-authoring a legal handbook on litigation in the Unified Patent Court (to be published).

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Chapter 12

Subramaniam & Associates

India

an application for interim reliefs, often ex parte reliefs as well as permanent injunction and damages. The Court may either grant an ex parte relief, which is usually an Order of injunction, or direct that a notice is served upon the defendant. Thereupon, copies of the plaint, along with the Order of Court, are served upon the defendant with a short leave (normally no more than a few days) to file its defence and show why the interim Order of injunction should not be passed, or why any Order of injunction passed ex parte should not continue. The defendant will file its reply along with an application for vacation of the interim Order, if any. The plaintiff will have an opportunity to file its rejoinder, after which the matter will be heard in order to determine whether the interim Order of injunction should be passed, or whether any such Order already passed ex parte should continue as such or with any modifications, or whether it should be vacated. The Court would be inclined to pass an interim Order of injunction if the plaintiff shows: (i) prima facie proof of validity of its patent; (ii) prima facie proof of infringement; (iii) balance of convenience in its favour; and (iv) absence of delay. After the interim stage, which could last from a few days to a few months, the matter proceeds to trial. The trial procedure would comprise: (i) service of the plaint and accompanying documents on the defendant; (ii) filing and service upon the plaintiff of the defendant’s reply, along with counterclaim for invalidation of the patent, if any; (iii) filing of a rejoinder by the plaintiff; (iv) hearing of the matter before the Registrar of the Court or, in special cases, before a judge, for completion of pleadings, admission and denial of documents, during which directions for the further conduct of the action including filing of evidence, filing of a list of witnesses, examination and cross-examination of witnesses, fixing of dates of next hearing, etc., are given; (v) framing of issues before the Court; (vi) exchange of lists of, and disclosure of, documents relevant to the issues; and (vii) argument of the case on merits before the Court. Normally, it takes anything from three to seven years for a matter to be completed on merits. As of now, Intellectual Property cases are won or lost during the interim stage, although efforts are being made by the Courts to “fast-track” Intellectual Property cases, particularly patent cases. However, on a positive note, the Commercial Courts, Commercial Division and Commercial Appelate Division of High Courts Act, 2015, No. 4 of 2016 was enacted and has been in operation now for more than a year. Under this legislation, the Courts are strictly enforcing time limits on litigants to ensure that the matter comes to trial within three years.The Courts’ fees normally depend upon the value of the damages and other reliefs sought, and could work out at about 10% of the total damages claimed.

1 Patent Enforcement

1.1 Before what tribunals can a patent be enforced against an infringer? Is there a choice between tribunals and what would influence a claimant’s choice?

There are no specialised Patent Courts in India. A suit for infringement of a patent cannot be instituted in a Court inferior to a District Court. Where the damages claimed exceed INR 20 million, a suit for infringement may also be instituted before a High Court, provided that it has ordinary original jurisdiction. Most High Courts in India only have Appellate jurisdictions. At present, only the High Courts of Chennai, Delhi, Kolkata and Mumbai have Ordinary Original jurisdiction. Where a counterclaim for revocation of the patent is made by the defendant, the suit, along with the counterclaim, is automatically transferred to the High Court. The procedure for conducting an infringement suit is governed by the relevant provisions of the Code of Civil Procedure. Infringement proceedings are instituted by filing a plaint along with the necessary applications for urgent hearing and interim reliefs before the District Court or the High Court as appropriate. A party aggrieved by the Order of the District Court may file an appeal before the High Court. Similarly, an Order of the High Court may be appealed to the Division Bench of the High Court. Further appeals may lie before the Supreme Court on special leave or certificate of fitness where substantial issues of law are involved. A party has limited choice in choosing the appropriate jurisdiction. Under the Code of Civil Procedure, a patentee may choose a jurisdiction where the defendant has a place of business or where the cause of action arises, i.e., where the infringing products are available. If the infringing products are available in multiple locations in India, the patentee may institute proceedings in a place which has jurisdiction. Forum shopping is not usually encouraged.

1.2 What has to be done to commence proceedings, what court fees have to be paid and how long does it generally take for proceedings to reach trial from commencement?

In order to initiate infringement proceedings, a patentee must first decide on the jurisdiction where the proceedings are to be initiated. The patentee may wish to first send a cease-and-desist notice to the defendant, but this is not mandatory. The proceedings will commence with filing a plaint at the appropriate Court along with

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material, invoices, samples of infringing articles and oral evidence by experts. Witnesses are subjected to examination and cross-examination.

1.5 How are arguments and evidence presented at the trial? Can a party change its pleaded arguments before and/or at trial?

The case will normally come up for arguments on merits after the interlocutory stage, and only after completion of pleadings, admission and denial of documents and filing of evidence. Apart from documentary evidence, expert evidence is presented as an affidavit; however, the parties to the proceedings, as well as the Court, may wish to submit oral testimony as well. Witnesses may be examined and cross-examined. Examination of the witnesses normally takes place before the Court, but in some cases, it may also take place before the Registrar or a Commissioner appointed by the Court. The oral proceedings commence with arguments by the plaintiff’s counsel, followed by defence by the defendant’s counsel and rejoinder by the plaintiff’s counsel. The judge would normally have read the case files in their entirety, but throughout the proceedings, he may ask questions and, where necessary, employ independent Scientific Advisors to assist the Court on matters of a technical nature.Our Code of Civil Procedure permits amendments of pleadings, but the sooner the amendments are sought, the better the chances are of their allowance. The Courts will not ordinarily permit a complete change of facts and arguments on which the pleadings are based, since they may raise new issues. In any case, the other party will have an opportunity to oppose or respond to such changes. Once the trial has begun, it will be more difficult to introduce new facts, arguments or evidence unless the party in question is able to justify its request for changing its pleaded arguments; for instance, unexpected emergence of new facts not previously known or not previously available despite best efforts and absence of negligence, delay and laches.

1.6 How long does the trial generally last and how long is it before a judgment is made available?

The trial, once it commences, may take anything from a few days to several weeks, but the entire pre-trial process after the interim stage, including various pre-trial procedures, could take anything from three to seven years although, under the Commercial Courts Act, efforts are on to place IP cases on a fast track. More often than not, the Courts pronounce their Order in the Court on a date specified in advance. A certified copy of the Order will be available in a matter of days; however, it may take a few weeks for the full decree sheet to be drawn up.

1.7 Are judgments made available to the public? If not as a matter of course, can third parties request copies of the judgment?

Judgments on IP cases are pronounced in the Court. They are also published in leading IP Journals. Third parties can request copies of judgments except where the judgment is based on settlement between parties and the terms of the settlement are confidential.

1.8 Are there specialist judges or hearing officers, and if so, do they have a technical background?

There are no specialist judges or hearing officers in a Court.

1.3 Can a party be compelled to disclose relevant documents or materials to its adversary either before or after commencing proceedings, and if so, how?

A party may be compelled to disclose relevant documents and materials to its adversary only through an Order of the Court.

1.4 What are the steps each party must take pre-trial? Is any technical evidence produced, and if so, how?

Pre-trial preparations are important. The patentee must ensure that it has sufficient material to establish proof of validity or patent, proof of infringement, and absence of delay. It must also ensure that it has carried out all the necessary groundwork properly, which includes making sure that all the evidence that it intends to rely upon and the expert witnesses are, or will be, available. The defendant should have its defences ready, including any material that it intends to rely upon to challenge the validity of the patent. The pre-trial procedural stages in a Civil Suit will normally comprise filing a plaint at the appropriate Court, along with an application for interim reliefs, often ex parte reliefs. In such a case, a notice is not served upon the defendant. The Court may either grant an ex parte relief, which is usually an Order of injunction, or direct that a notice is served upon the defendant. Thereupon, copies of the plaint, along with the Order of Court, are served upon the defendant with a short leave, normally no more than a few days, to file its defence and show why the interim Order of injunction should not be passed, or why any Order of injunction passed ex parte should not continue. The defendant will file its reply along with an application for vacation of the interim Order, if any. The plaintiff will have an opportunity to file its rejoinder, after which the matter will be heard in order to determine whether the interim Order of injunction should be passed, or whether any such Order already passed ex parte should continue as such or with any modifications, or whether it should be vacated. The Court would be inclined to pass an interim Order of injunction if the plaintiff shows: (i) prima facie proof of validity of its patent; (ii) prima facie proof of infringement; (iii) balance of convenience in its favour; and (iv) absence of delay. After the interim stage, which could last from a few days to a few months, the matter proceeds to trial. Duty of candour, which is sometimes referred to as the “doctrine of clean hands”, is important. Any material suppression or distortion of facts could adversely affect the reliefs at the interim stage. The trial procedure would comprise: (i) service of the plaint and accompanying documents on the defendant; (ii) filing and service upon the plaintiff of the defendant’s reply along with counterclaim for invalidation of the patent, if any; (iii) filing of a rejoinder by the plaintiff; (iv) hearing of the matter before the Registrar of the Court or, in special cases, before a judge, for completion of pleadings, admission and denial of documents, during which directions for the further conduct of the action including filing of evidence, filing of a list of witnesses, examination and cross-examination of witnesses, fixing of dates of next hearing, etc., are given; (v) framing of issues before the Court; (vi) exchange of lists of, and disclosure of, documents relevant to the issues; and (vii) argument of the case on merits before the Court. Normally, it takes anything from three to seven years for a matter to be completed on merits. As of now, Intellectual Property cases are won or lost during the interim stage, although efforts are being made by the Courts to “fast-track” Intellectual Property cases, particularly patent cases. Technical evidence is an important aspect of patent infringement and invalidation proceedings. The evidence may be documentary evidence, affidavits and declarations by experts, publicly available

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1.12 Can a party be liable for infringement of a process patent by importing the product when the process is carried on outside the jurisdiction?

Unauthorised import of a product into India manufactured outside India by a process patented in India would constitute infringement, and the party committing such act would be liable for infringement.

1.13 Does the scope of protection of a patent claim extend to non-literal equivalents?

India does not have judicial precedents for doctrine of equivalents, but the Courts would be inclined to purposively construe the claims in order to determine whether or not the acts complained of result in infringement. The effect of such interpretation may, in certain cases, be analogous to the doctrine of equivalents.

1.14 Can a defence of patent invalidity be raised, and if so, how? Are there restrictions on such a defence e.g. where there is a pending opposition?

Yes, a defence of patent invalidity may be raised. A petition for revocation of a patent or a counterclaim for invalidity or revocation may also be filed, provided that the defendant has not previously exercised the option of filing a post-grant opposition before the Patent Office or revocation proceedings before the Intellectual Property Appellate Board. A defendant may plead that its acts do not infringe any claim of the patent in question. In addition, it may plead that any claim or claims in question are not valid. The counterclaim is required to state the grounds on which revocation is sought, supported by copies of the documents and evidence relied upon.

1.15 Other than lack of novelty and inventive step, what are the grounds for invalidity of a patent?

Apart from lack of novelty and inventive step, a patent may be invalidated on the grounds of: (i) wrongful obtainment; (ii) prior public knowledge or use in India; (iii) secret use in India; (iv) it is not classed as an invention under the Patents Act 1970, i.e., the subject matter of the invention falls under the negative list; (v) lack of enablement, insufficiency of description or unfair description; (vi) lack of industrial applicability; (vii) no factual basis; (viii) fraud; (ix) non-disclosure or wrongful disclosure of information in respect of corresponding foreign applications; (x) non-disclosure or wrongful disclosure of the source or geographical origin of the biological material used for the invention; (xi) contravention of any secrecy direction issued by the Government; (xii) wrongful claim of priority; or (xiii) traditional knowledge.

1.16 Are infringement proceedings stayed pending resolution of validity in another court or the Patent Office?

Whether infringement proceedings are to be stayed pending resolution of validity of the patent would be a matter of discretion of the Court, depending upon the facts and circumstances of each case. In the recent past, Delhi High Court has passed interim orders of injunction despite the fact that petitions for revocation of patents had been filed before suits for infringement were instituted. Where the defendant has not yet commenced manufacturing, the Courts may be inclined to direct the defendant to maintain the status quo even

However, the Court may, at any time during the proceedings, whether or not any application has been made by any party for that purpose, appoint an independent Scientific Advisor to assist the Court and report upon any question of fact. The person appointed as a Scientific Advisor would have a degree in science, engineering or technology (or equivalent) and at least 15 years of practical or research experience, and would also hold or have held a responsible post in a scientific or technical department of the Central or State Government or in any organisation.However, the Intellectual Property Appellate Board will have a qualified technical member with at least a master’s degree in science and 15 years of experience either as Patent Controller or a Patent Attorney.

1.9 What interest must a party have to bring (i) infringement, (ii) revocation, and (iii) declaratory proceedings?

(i) A suit for infringement may be instituted by a patentee or, if the patentee refuses, by a registered exclusive licensee or, where applicable, by a compulsory licensee. If the patent is assigned after the commencement of the action, the assignee may join as a co-plaintiff.

(ii) Revocation for a patent may be filed only by a “person interested”, i.e., a person who has a locus standi. A “person interested” is normally a person who would be affected by the continuance of the patent, such as a person engaged in, or engaged in promoting research in, the field to which the invention relates, or a person who has a manufacturing, trading or other commercial interest in the subject matter of the patent.

(iii) A declaratory action may be instituted by a “person interested”, i.e., a person affected by the existence of the patent and who would be interested in: (a) invalidation of the patent; (b) obtaining a declaration of non-infringement; or (c) restraining the patentee from groundless threats of infringement.

1.10 If declarations are available, can they address (i) non-infringement, and/or (ii) claim coverage over a technical standard or hypothetical activity?

Yes, but only if the person seeking declaratory judgment had written to the patentee to confirm non-infringement, but the patentee refused to do so.

1.11 Can a party be liable for infringement as a secondary (as opposed to primary) infringer? Can a party infringe by supplying part of, but not all of, the infringing product or process?

Yes. Apart from a person who actually manufactures the infringing article or uses the patented process, others who are indirectly connected with the manufacture or sale of the patentable article or part of the article may also be held guilty of infringement. This would be particularly true where the manufacturer or seller of the part is aware, or is expected to be aware, that use of the part would result in, or contribute to, the infringement of the final product. If a person sells a patented product in parts which are manufactured so as to be adapted to be put together to result in the patented article, such an act would constitute infringement of the patented product. There are not many precedents in India for contributory infringement, but the Indian Courts would be inclined to follow British precedents in this respect.

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natural and direct unlawful actions of the defendant, but the other factors that may be considered while awarding damages would be whether the patentee is commercially working the patented invention in India, or whether the patented products are properly marked with a patent number. Ordinarily, there are no punitive damages for “wilful” infringement. Usually, the Court would seek to compensate the plaintiff, not monetarily punish the defendant, unless the defendant is guilty of any misconduct including misrepresentation or suppression of material facts. In such cases, the Court may impose additional costs on the defendant. Where the patentee seeks account of profits instead of damages, the Court will ascertain how much of the patentee’s invention was actually appropriated in order to determine what proportion of the net profits realised by the infringer was attributable to its use.

1.20 How are orders of the court enforced (whether they be for an injunction, an award of damages or for any other relief)?

Orders of the Court are enforced by a specific decree of the Court along with directions to the parties and appropriate enforcing officers. Any party who refuses to abide by the Court’s orders will be guilty of Contempt of the Court.

1.21 What other form of relief can be obtained for patent infringement? Would the tribunal consider granting cross-border relief?

The Court may order that the infringing articles are seized, forfeited or destroyed, as it deems fit in the circumstances of the case without payment of any compensation to the defendant. Cross-border reliefs are not common in patent infringement suits.

1.22 How common is settlement of infringement proceedings prior to trial?

As of today, after the interim stage, most infringement suits are settled prior to trial.

1.23 After what period is a claim for patent infringement time-barred?

The period of limitation for instituting a suit for patent infringement is three years from the last committed act of infringement. Where the infringing activity is a continuing one, the three-year limitation will not apply. However, delay in instituting a suit, even if within a limitation period, may affect the chances of obtaining any interim relief. In addition, if there is too much delay in bringing an action, the defendant may raise the plea of acquiescence.

1.24 Is there a right of appeal from a first instance judgment, and if so, is it a right to contest all aspects of the judgment?

Yes, there is a right of appeal from a first instance judgment, and it includes a right to contest all aspects of the judgment. For instance, where the suit is instituted before a District Court, a party aggrieved by the Order of the District Court may file an appeal before the High Court. Similarly, an Order of the High Court may be appealed to the Division Bench of the High Court. Further appeal may lie before the Supreme Court on special leave or certificate of fitness where substantial issues of law are involved.

though it may have filed a petition for revocation of the patent before the suit for infringement was instituted. The factors which would affect such discretion would be: the forum before which invalidation proceedings are pending; whether the suit for invalidation was filed prior to, or subsequent to, the suit of infringement; whether or not there is an injunction operative against the defendant; and whether or not and how long ago the alleged infringing acts commenced. The question would always be one of determining in whose favour the balance of convenience lies. Where the validity of a patent has already been called into question prior to the institution of the suit for infringement, the Court may be disinclined to grant ex parte reliefs or may order that the suit for infringement is transferred to the High Court where the invalidity proceedings are being held or vice versa. The Court may also order an interim injunction with a cross-undertaking by the plaintiff for damages in the event that the patent is found to be invalid. Alternatively, the Court may order the defendant to file periodical statements of accounts before the Court.

1.17 What other grounds of defence can be raised in addition to non-infringement or invalidity?

A defendant can make an application for a compulsory licence on the grounds that the patent has not worked to an adequate extent in India to meet the demands of the public, or that the patented article is not available to the public at a reasonable price. The defendant may also claim lack of knowledge of the patent, particularly where the patentee has failed to mark its products with its patent number. All such defences may be material only for calculating the damages, but not for arriving at a finding of infringement.

1.18 Are (i) preliminary, and (ii) final injunctions available, and if so, on what basis in each case? Is there a requirement for a bond?

(i) Preliminary (interim) injunctions are available when the plaintiff establishes: (a) a prima facie proof of validity of its patent; (b) a prima facie proof of infringement; (c) a balance of convenience in its favour; and (d) absence of delay.

(ii) Final/permanent injunction is granted after hearing both the parties on the merits of the suit. It will be limited for the duration of the patent. Injunction may be granted not only where actual infringement is proved, but also where a threat to infringe has been established. In cases where the patent has expired before hearing the suit, the question of injunction will not arise. However, the plaintiff would still be entitled to damages or account of profits arising from acts committed before the expiry of the patent.

The Court may require either party to furnish a bond.

1.19 On what basis are damages or an account of profits assessed?

For assessment of damages, the patentee will have to lead proper evidence of the extent of sales by the defendant, loss of business opportunities and other harm suffered by it. It may also seek an Order from the Court to enjoin the defendant to file monthly or quarterly statements of its sales, pending trial. The relief of damages or account of profits which the Court may grant to a successful plaintiff will be determined by several factors, including certain statutory limitations. Damages or account of profits may not be granted in cases where the defendant proves that it was not aware, and had no reasonable grounds to believe, that the patent existed at the time of the infringement. In assessing damages, the primary consideration is the loss sustained by the patentee as a result of the

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and know-how; therefore, Indian law has had, in the past, several restrictions, checks and balances, including royalty limits of 5% on net domestic sales and 8% on exports. However, these restrictions have been done away with. Nevertheless, India has strict Foreign Exchange Control laws to prevent money laundering; therefore, if the Reserve Bank of India feels that a particular rate of royalty charged does not seem appropriate, the parties may be called upon to provide an explanation. The Indian Patents Act also stipulates that it is unlawful to include in a licence agreement any restrictive conditions which prohibit the licensee from using or acquiring from any third party any process or article other than that forming the subject of the patent.

3.2 Can a patent be the subject of a compulsory licence, and if so, how are the terms settled and how common is this type of licence?

Yes, a compulsory licence may be granted by the Controller to any interested person on any of the following grounds:i) that the reasonable requirements of the public with respect to

the patent invention have not been satisfied; ii) that the patented invention is not available to the public at a

reasonably affordable price; oriii) that the patented invention is not worked in the territory of

India.The Controller can entertain an application for a compulsory licence only after the expiration of three years from the date of the sealing of the patent.In settling the terms and conditions of a licence, the Controller shall endeavour to secure that:i) royalties and other remunerations, if any, reserved for the

patentee or other person beneficially entitled to the patent, are reasonable having regard to the nature of the invention, the expenditure incurred by the patentee in making the invention or in developing it and obtaining a patent and keeping it in force or other relevant factors;

ii) the patented invention is worked to the fullest extent by the person to whom the licence is granted and with reasonable profit to him;

iii) the patented articles are made available to the public at reasonable and affordable prices;

iv) the licence granted is a non-exclusive licence;v) the right of the licensee is non-assignable;vi) the licence is for the balance term of the patent unless a

shorter term is consistent with the public interest;vii) the licensee is granted with a predominant purpose of

manufacture and supply in the Indian market and that the licensee may also export the patented product;

viii) in the case of semi-conductor technology, the licence granted is to work the invention for public, non-commercial use; and

ix) in cases where the licence is granted to remedy a practice determined after judicial or administrative process to be anti-competitive, the licensee shall be permitted to export the patented products, if so required.

No licence granted by the Controller shall authorise the licensee to import the patented article or an article or substance made by a patented process from abroad where such importation would, but for such authorisation mentioned in (ix) above, constitute an infringement of the rights of the patentee. In the last two decades, only one compulsory licence was granted a few years ago.

1.25 What are the typical costs of proceedings to first instance judgment on (i) infringement, and (ii) validity? How much of such costs are recoverable from the losing party?

Typically, the cost of a straightforward infringement action would be approximately USD 75,000–100,000. The cost may double if there is an invalidation action as well. The costs may also go up significantly (from 100% to 150%) if a Senior Counsel is engaged to argue the case. Less than 20% would be recoverable from the defendant.

1.26 For jurisdictions within the European Union: What steps are being taken in your jurisdiction towards ratifying the Agreement on a Unified Patent Court, implementing the Unitary Patent Regulation (EU Regulation No. 1257/2012) and preparing for the unitary patent package? For jurisdictions outside of the European Union: Are there any mutual recognition of judgments arrangements relating to patents, whether formal or informal, that apply in your jurisdiction?

This is not applicable.

2 Patent Amendment

2.1 Can a patent be amended ex parte after grant, and if so, how?

A patent may be amended after grant only subject to third-party rights to oppose such amendment, and provided that no proceedings in respect of infringement or invalidation of the patent are pending before any Court of law in India. A patent may be amended after a request at the Indian Patent Office is granted. The request should clearly mention the full particulars of amendments and the reasons for amendment. Normally, only amendments by way of correction, explanation or disclaimers are allowed. No amendment which brings in new matter or which broadens the scope of any claim as originally filed will be permitted. The nature of the proposed amendment is published in the Journal. Any interested person may oppose the amendment within three months of publication thereof.

2.2 Can a patent be amended in inter partes revocation/invalidity proceedings?

Yes, subject to the amendments meeting with the requirement of law, and the right of a hired party to oppose such amendments, a patent may be amended inter partes in the revocation proceedings.

2.3 Are there any constraints upon the amendments that may be made?

Amendments may be allowed only if such amendments are by way of correction, explanation or disclaimer, do not introduce new matter and do not broaden the scope of any claim before amendment.

3 Licensing

3.1 Are there any laws which limit the terms upon which parties may agree a patent licence?

Licensing of patents would often include transfer of technology

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(p) an invention relating to atomic energy or an invention which has been held by an Order of the Central Government to be relevant to the defence of India purposes.

5.2 Is there a duty to the Patent Office to disclose prejudicial prior disclosures or documents? If so, what are the consequences of failure to comply with the duty?

There is no duty to disclose prejudicial prior disclosures or documents to the Indian Patent Office as such, unless the Controller of Patents specifically asks for such information. However, once the Controller asks for such information, which may include not only such prejudicial prior art but all prior art and search and examination reports issued on all corresponding foreign applications, including claim amendments, the applicant is required to submit such information within six months from the date on which such requirement is raised. While this duty is not ongoing, there is an ongoing duty to convey to the Patent Office details of all corresponding foreign applications, and also to keep the Patent Office updated regarding all subsequent developments such as publications, abandonments, refusals and grants within six months of the dates of such events.Failure to comply with this requirement will render the application liable to be refused in a third-party opposition or, where the patent has been granted, render it liable to be cancelled in third-party opposition proceedings. Patent applications have been refused and granted patents have been revoked on this ground in the recent past.

5.3 May the grant of a patent by the Patent Office be opposed by a third party, and if so, when can this be done?

Yes, the grant of a patent may be opposed by filing:(a) a pre-grant opposition by any person at any time after

publication of the patent application and before the grant;(b) a post-grant opposition by any person interested within one

year from the date of publication of the grant; or(c) a revocation petition before the Intellectual Property

Appellate Board at any time after the grant.The grounds of opposition are:(a) Wrongful acquisition.(b) Prior publication/prior claim.(c) Prior claim in India.(d) Prior public knowledge or public use in India.(e) Obviousness and lack of inventive step.(f) Not an invention or the invention is not patentable.(g) Insufficient description of the invention.(h) Failure to disclose information or furnishing false inform-

ation relating to foreign filing.(i) Convention application not filed within the prescribed time.(j) Incorrect mention of source/geographical origin of biological

material.(k) Invention anticipated with regard to traditional knowledge of

any community, anywhere in the world.

5.4 Is there a right of appeal from a decision of the Patent Office, and if so, to whom?

An appeal against a decision of the Controller may be filed before the Intellectual Property Appellate Board (IPAB) within a period of three months from the date of decision. However, in respect of a

4 Patent Term Extension

4.1 Can the term of a patent be extended, and if so, (i) on what grounds, and (ii) for how long?

The term of an Indian patent cannot be extended under any circumstances.

5 Patent Prosecution and Opposition

5.1 Are all types of subject matter patentable, and if not, what types are excluded?

A number of types of subject matter are excluded from being patentable under the Indian Patents Act. The Indian law includes a negative list of inventions which are precluded from patentability. Under the law, the following inventions are not patentable: (a) an invention which is frivolous or which claims anything

obviously contrary to well-established natural laws;(b) an invention, the primary or intended use or commercial

exploitation of which would be contrary to public order or morality or which causes serious prejudice to human, animal or plant life or health or to the environment;

(c) the mere discovery of a scientific principle or the formulation of [or discovery of any living thing or non-living substance occurring in nature];

(d) the mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance or the mere discovery of a new property or new use for a known substance or of the mere use of a known process, machine or apparatus unless such known process results in a new product or employs at least one new reactant;

(e) a substance obtained by a mere admixture resulting only in the aggregation of the properties of the components thereof or a process for producing such substance;

(f) the mere arrangement or re-arrangement or duplication of known devices each functioning independently of one another in a known way;

(g) a method of agriculture or horticulture;(h) any process for the medicinal, surgical, curative, prophylactic

[diagnostic, therapeutic] or other treatment of human beings or any process for a similar treatment of animals to render them free of disease or to increase their economic value or that of their products;

(i) plants and animals in whole or any part thereof other than microorganisms but including seeds, varieties and species and essentially biological processes for production or propagation of plants and animals;

(j) a mathematical or business method or a computer program per se or algorithms;

(k) a literary, dramatic, musical or artistic work or any other aesthetic creation whatsoever including cinematographic works and television productions;

(l) a mere scheme or rule or method of a performing mental act or method of playing game;

(m) a presentation of information;(n) topography of integrated circuits;(o) an invention which, in effect, is traditional knowledge or

which is an aggregation or duplication of known properties of traditionally known component or components; or

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of goods suspected to be infringing the product. Such notice is registered or rejected within 30 working days of the date of receipt of the notice. In cases where the notice is registered, the minimum validity period shall be one year, unless the rights holder requests for a shorter period of Customs assistance or action. The Customs department may, ex officio, suspend the clearance of the alleged counterfeit goods or give a notice if the department has prima facie evidence or reasonable grounds to believe the goods are counterfeit. The Customs department is under a duty to inform the rights holder immediately about suspension of clearance of goods with the reasons for such suspension. Goods suspended for clearance are to be released on notice within 10 days (extendable for a further 10 days) when the rights holder fails to join proceedings or on the department’s own initiative within five days, when the rights holder fails to give notice or fails to fulfil the obligation of executing bond. The period of suspension of release of perishable goods is three days. The department is authorised to seize and confiscate the goods infringing Intellectual Property Rights where it has reason to believe that the goods are infringing Intellectual Property and are thus liable to be confiscated under the Customs Act. In cases where the Customs department determines that the goods detained or seized have infringed Rights and have been confiscated under Section 111(d) of the Indian Customs Act 1962, the department shall destroy such goods under official supervision or dispose of them through the normal channels of commerce after obtaining no objection from the rights holder.However, while border measures have been successfully enforced in respect of trademarks and copyright infringement, they have not been enforced on patent matters.

7 Antitrust Law and Inequitable Conduct

7.1 Can antitrust law be deployed to prevent relief for patent infringement being granted?

As long as the patent is found to be valid, antitrust law or inequitable conduct will not affect permanent injunction. However, inequitable conduct of the patentee could affect the grant of interim relief, as well as the quantum of the damages awarded. The Court may also impose heavy costs on the patentee.

7.2 What limitations are put on patent licensing due to antitrust law?

While India has recently enacted a Competition law, it does not have any bearing on patent licensing. However, the Patent Act prohibits the insertion of certain restrictive conditions in the licence agreement, as mentioned in question 3.1 above.

8 Current Developments

8.1 What have been the significant developments in relation to patents in the last year?

In the last year, the Indian Patent Office has recruited over 300 Examiners. The Indian Patent application process has become 90% paperless, with all communications including office actions, letters and patent documents being issued only electronically. The due date for filing a reply to the Office action is six months, which is extendible by three months provided the request for extension is filed before the expiry of the initial six-month period. Secondly, Office

pre-grant opposition, only an applicant has the right of appeal. The opponent does not have a right of appeal.

5.5 How are disputes over entitlement to priority and ownership of the invention resolved?

Issues with respect to priority dates are settled between the applicant and the Patent Office during prosecution, and inter partes during opposition proceedings. A certified copy of the priority document constitutes prima facie proof of the priority claimed. However, this can be challenged by either the Patent Office or an opponent, by showing that the basic application from which the priority is claimed was not, in fact, the first application in a Paris Convention Country. Under the law, when an application is filed by a person who is not the first and true inventor, the applicant is required to file proof of the right to file the application. However, it is open for any person to oppose the application or apply for revocation of the granted patent on the grounds that the invention was wrongfully obtained by him. In either case, the applicant or the patentee will be given an opportunity to file its reply and evidence and, after hearing both the parties, the concerned authority (i.e., the Patent Office, Appellate Board or the Court) will issue its decision.

5.6 Is there a “grace period” in your jurisdiction, and if so, how long is it?

Whether or not there is a grace period depends on the nature of the action in question. There is no grace period for entering the national phase 31 months after the priority date. Similarly, there is no grace period for filing a request for examination after the prescribed period of 48 months from the priority date. There is a grace period of six months for payment of renewal fees. However, if the publication of the invention has taken place prior to filing in India in a Government-recognised exhibition or before a Learned Society, there is a grace period of one year to file the application in India. There are also grace periods for the completion of various formality actions as required by our Patent Rules, as long as the Patent Act does not specifically prohibit such extension of time or condonation of delay. There is also a grace period of 12 months for filing an application for a patent in India after its publication, provided the publication took place in a government-recognised exhibition or literary society or is for a reasonable trial and experiment, provided that the nature of invention is such that such trial could only be carried out in public.

5.7 What is the term of a patent?

The term of a patent is 20 years from the date of filing.

6 Border Control Measures

6.1 Is there any mechanism for seizing or preventing the importation of infringing products, and if so, how quickly are such measures resolved?

The Indian Customs Act 1962 prohibits the importing of goods that infringe Intellectual Property. The Indian Government has also notified Intellectual Property Rights (Imported Goods) Enforcement Rules 2007 to strengthen the statutory and executive guidelines for the protection of Intellectual Property Rights. Under the rules, an Intellectual Property Rights holder may give notice to the Custom Commissioner requesting suspension of clearance

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Hari SubramaniamSubramaniam & AssociatesCentral Square, Suite 328, Plaza-III20 Manoharlal Khurana Marg, Bara Hindu Rao (off Rani Jhansi Road)Delhi-110 006India

Tel: +91 11 3016 5700Fax: +91 11 3016 5798Email: [email protected]: www.sna-ip.com

Hari Subramaniam is an IPR attorney-at-law with a background in Biological Sciences. He has been in practice for 35 years and has been involved in over 35,000 cases in India and abroad. He has often been rated as the No. 1 patent attorney in the country in prosecution and contentious proceedings. He is a regular speaker at various workshops and conferences on Intellectual Property Laws worldwide, including AIPPI, FICPI, APAA, IPO, IBC, C5, ABA, WIPO, and US and European universities. He has published several IP-related articles in leading international books and journals. He has been an expert witness before the Parliament for the amendment of Patent laws and has played a key role in the development of patent laws in India. Voted as “Leading Asia IPR Lawyer” by Asia Law for 15 consecutive years, he is currently a Councillor of the Asian Patents Attorneys Association (APAA), and the President of APAA, India Chapter (for the second time). He has been singled out by peers and clients as a top patent prosecutor and enforcer in the Asia-Pacific, and has been highly acclaimed for his skills in providing solutions to most complex IP matters, along with remarkable legal and technical skills in patent oppositions. He has been voted as a leading IP lawyer by various law publications such as Managing Intellectual Property, Chambers Asia-Pacific, Asia Legal 500, IAMS, and India Lawyers 250, and as “IP Lawyer of the Year 2013” by Corporate INTL and Acquisition International (M&A). He featured in the cover story “50 Patent Lawyers one must know in Asia and Pacific” in the March issue of Asia Law.

Subramaniam & Associates (SNA) boasts a very impressive list of clients and represents several Fortune 500 companies, leading corporations, universities and law firms from all over the world. It also represents a large number of domestic corporations, public sector undertakings, universities and research institutions. The firm is equipped to provide complete and highly cost-effective services, from the drafting, filing and prosecution of applications to searches, oppositions and enforcement. SNA is particularly known for its huge success rate in patent opposition and contentious proceedings. SNA is one of the largest filers of PCT International Applications from India, and is regarded by the Indian Patent Office and the industry as a top IP firm in India. With representation in major cities of India such as Calcutta, Chennai and Mumbai, SNA is well-positioned to serve its clients’ domestic and international needs.

actions are no longer issued but oral proceedings are appointed if any objection remains after filing a response to the first Office action. A serious initiative has been undertaken by the Government of India to clear the backlog of pending cases.

8.2 Are there any significant developments expected in the next year?

There will be an increase in suits for infringement. We are also hopeful that patent infringement cases will be fast-tracked.

8.3 Are there any general practice or enforcement trends that have become apparent in your jurisdiction over the last year or so?

There has been an increase in the number of applicants approaching the Courts to enforce their patents or challenging the validity of patents, or even challenging the decisions of the Indian Patent Office. While, prima facie, it may appear that India is not a very patentee-friendly jurisdiction, in all the cases where no injunction restraining the defendant was granted, there was a credible challenge to the validity of the patent. Indian law does provide for certain inbuilt safeguards in the national interest in the form of a negative list of inventions which are not patentable, compulsory licences, etc., and the Indian Courts have, with all seriousness, started enforcing these provisions. In the last few years, the Indian High Courts, particularly the High Court of Delhi, have enforced patents and injuncted defendants in all areas of technology. This will be good news for rights holders.

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Ireland

Either party may deliver a notice for particulars seeking further particulars of the other side’s claim. In the Commercial Court, these procedural stages must be complied with according to directions given by the judge in charge of the Commercial List at various stages including the initial directions hearing, the case management conference and the pre-trial conference. Initial directions are made by the court upon, or soon after, entry of the case into the Commercial List and usually provide a timetable for the exchange of pleadings. The range of directions which may be made is broad and can include requiring the parties to provide information relevant to the proceedings such as intended witnesses, or particulars of a technical nature, or the examination on oath of any witness in the case. A case management conference may be held to ensure, inter alia, that initial directions have been complied with, that the issues of fact and law in dispute are defined, and/or that all pleadings have been delivered.Pre-trial conferences may be held before a case goes to trial in the Commercial Court so that the court has a clear picture of the state of the case before trial. At this conference, a judge will also seek to establish practical issues such as the likely length of the trial and whether any special technological arrangements may be required.Nominal stamp duty is payable when issuing proceedings and filing affidavits. The only significant court fee that exists in Ireland is a fee of €5,000 which is payable by the party seeking to have the case transferred to the Commercial List.There is no set time limit within which a case has to reach trial. The time taken will depend on the complexity of the case and whether there are pre-trial disputes in relation to, in particular, discovery. Patent actions in the Commercial List generally reach trial within 12 to 18 months from commencement.

1.3 Can a party be compelled to disclose relevant documents or materials to its adversary either before or after commencing proceedings, and if so, how?

Patent litigation in Ireland almost inevitably involves the parties having to make documentary discovery to one another. Discovery arises once the pleadings are closed. The court rules require an applicant for discovery to demonstrate that the documents sought are both relevant and necessary for the fair disposal of the case or to save costs.Relevance has been held to mean “every document relating to the matters in question in the action, which not only would be evidence upon any issue, but also which, it is reasonable to suppose, contains

1 Patent Enforcement

1.1 Before what tribunals can a patent be enforced against an infringer? Is there a choice between tribunals and what would influence a claimant’s choice?

In Ireland, patents are governed by the Patents Act 1992, as amended (the “PA 1992”). Ireland has no specialist patent court. Patents are enforced by instituting proceedings in the High Court, Ireland’s highest court of first instance. The Commercial Court is a division of the High Court, and patent disputes are often transferred into that division. Cases admitted into the Commercial List are subject to a case management system intended to ensure that they are progressed in a manner which is “just, expeditious and likely to minimise the costs of proceedings”. The Commercial Court’s ability to deal with complex cases within timeframes which are pre-determined and which reflect commercial needs and realities has made Ireland a more attractive jurisdiction in which to litigate intellectual property rights.Enforcement proceedings in respect of short-term (10-year) patents may be brought in the Circuit Court, Ireland’s second-highest court of first instance.

1.2 What has to be done to commence proceedings, what court fees have to be paid and how long does it generally take for proceedings to reach trial from commencement?

A plenary summons is used to commence infringement proceedings and a petition is used to commence revocation proceedings.The procedural stages which must be adhered to by the plaintiff (or petitioner) (π) and defendant (Δ) are the following:■ Issue of plenary summons for infringement (or petition for

revocation) (π). ■ Entry of Appearance (Δ).■ Delivery of Statement of Claim together with Particulars of

Infringement (or Particulars of Objections) (π). ■ Delivery of Defence and Counterclaim (if any) (Δ).■ Reply (and Defence to Counterclaim) (π).■ Discovery (π, Δ).■ Exchange of Witness Statements and Legal Submissions (π, Δ).■ Trial.

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1.6 How long does the trial generally last and how long is it before a judgment is made available?

Both the length of the trial and the time it takes for the judgment to be handed down depend largely on the complexity of the case and the number of witnesses involved in the proceedings. The procedures which operate in the Commercial Court are designed to ensure that the issues in dispute have been clearly identified by the parties prior to trial so that the trial can proceed in as time-efficient a manner as possible. Patent trials involving infringement and validity would generally take seven to 10 days, depending on the complexity of the case. Reserved judgments are generally delivered approximately one to three months later.

1.7 Are judgments made available to the public? If not as a matter of course, can third parties request copies of the judgment?

Yes. Judgments are published on the Courts Service website www.courts.ie and in the Irish Reports.

1.8 Are there specialist judges or hearing officers, and if so, do they have a technical background?

There are no specialist patent judges in Ireland. Nevertheless, Commercial Court judges in particular will usually have gained experience litigating complex intellectual property matters as counsel prior to their appointments as judges. Furthermore, since Irish patent law is broadly similar to that of the UK, Irish courts enjoy the guidance of the decisions of expert judges from that jurisdiction in particular.While the PA 1992 provides that the court may, if it thinks fit, and shall, on the request of all parties to the proceedings, “call in the aid of an assessor specially qualified in the opinion of the court and try the case wholly or partially with his assistance”, this provision is not deployed in the majority of cases.

1.9 What interest must a party have to bring (i) infringement, (ii) revocation, and (iii) declaratory proceedings?

(i) An infringement action may be brought by either the proprietor or the exclusive licensee in his own right. Where the exclusive licensee brings the action, the proprietor, unless joined as a co-plaintiff, must be named as a defendant to the proceedings. Similarly, where any co-proprietor does not concur in the bringing of infringement proceedings by another co-proprietor, the non-concurring co-proprietor must be joined as a defendant. The purpose of joining such parties as defendants in this way is to give them notice of the action; however, they will not be liable for any costs unless they enter an appearance and take part in the proceedings.

(ii) Revocation proceedings may be taken by “any person” before the court or the Controller. No special interest need therefore be demonstrated by such person.

(iii) Any person may apply for a declaration that he has not acted in a manner that infringes a patent, provided that he has first written to the proprietor (or licensee) for written acknowledgment that he is not infringing and has been refused such acknowledgment.

Any person may refer to the court the question whether, by operation of law or otherwise, he is entitled to any Irish patent or patent application, and the court may make such order (including an order

information which may – not which must – either directly or indirectly enable the party requiring the affidavit either to advance his own case or to damage the case of his adversary”.The documents sought must also satisfy the requirement that the discovery sought is necessary for disposing fairly of the case or for saving costs. An applicant is not entitled to discovery based on what has traditionally been described as a fishing expedition.The Rules of the Superior Courts provide for the discovery of documents which are, or which have been, in a person’s possession or power and, if privilege is claimed, the court may inspect the documents to decide on the validity of the claim of privilege. Confidentiality, as distinct from privilege, is not an absolute bar to disclosure; however, the court may limit the inspection of such documents to, for example, the legal advisors.

1.4 What are the steps each party must take pre-trial? Is any technical evidence produced, and if so, how?

Each party must set out its case by means of the exchange of pleadings referred to in question 1.2 above, witness statements (including experts) and written legal submissions. In an action for infringement, ‘Particulars of Infringement’, setting out which of the claims are alleged to be infringed and giving at least one instance of each type of infringement of which a complaint is made, are delivered to the defendant together with the Statement of Claim. The defendant, if he disputes the validity of the patent, must deliver with his defence particulars of the objections on which he relies in support of such invalidity. Particulars of objections must state every ground on which the validity of the patent is disputed, and must give such particulars as will clearly define every issue which it is intended to raise.All technical evidence and related expert witness statements must be produced by the parties in advance of the trial. Opposing experts are often directed by the court to meet in advance of the trial in order to narrow down the issues of dispute as much as possible.

1.5 How are arguments and evidence presented at the trial? Can a party change its pleaded arguments before and/or at trial?

It is a fundamental principle of the Irish law of evidence that witness testimony is given by word of mouth. However, in patent cases, it is frequently agreed that the witness statements shall be taken as evidence in chief subject to elaboration and to the opponent having the right to ask questions by way of examination in chief for the purpose of dealing with issues that arise out of the witness statements and any other points of clarification or correction that may arise.Written legal submissions are exchanged in advance of trial, and oral legal submissions are generally made at the opening and closing of the trial. An amendment of pleadings may require the permission of the court. A party will generally be entitled to amend his pleadings before trial, provided that irreparable prejudice is not suffered by the opposing party. If the leave of the court to make the amendment is required (which depends largely on timing and the nature of the proposed amendment), then the party that is seeking leave to amend may be required to pay the costs of the opposing party. Application for leave to amend may be made by either party to the court at the trial of the action, and such amendment may be allowed upon such terms as to costs or otherwise as may be just.

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proceedings. In all circumstances, the validity of a patent may be challenged on the grounds referred to in question 1.15 below.

1.15 Other than lack of novelty and inventive step, what are the grounds for invalidity of a patent?

A patent may be revoked on the grounds that:■ the subject-matter of the patent is not patentable under the

Act;■ the specification of the patent does not disclose the invention

in a manner sufficiently clear and complete for it to be carried out by a person skilled in the art;

■ the matter disclosed in the specification of the patent extends beyond that disclosed in the application as filed;

■ the protection conferred by the patent has been extended by an amendment which should not have been allowed; or

■ the registered proprietor of the patent is not entitled to it (by reason of the fact that he is, for example, neither the inventor nor his employer).

1.16 Are infringement proceedings stayed pending resolution of validity in another court or the Patent Office?

Irish infringement proceedings are susceptible to being stayed, particularly when opposition proceedings are pending before the EPO. If there are already court proceedings pending in Ireland in relation to the patent, it is not possible to take revocation proceedings before the Controller without leave of the High Court. However, where validity proceedings are already in existence before the Controller, then the court has discretion to stay infringement proceedings pending the Controller’s decision. Findings as to the validity of a corresponding patent by a foreign national court have no legal effect on the validity of an Irish patent under Irish law. Therefore, no automatic stay of Irish infringement proceedings would arise simply because of a validity challenge in a foreign court. However, the Irish court could, upon application being made to it, stay the proceedings in such circumstances if it were to find a practical basis for doing so.

1.17 What other grounds of defence can be raised in addition to non-infringement or invalidity?

Consent, express or implied, is a defence to patent infringement. A defence may also arise in connection with the limitations on the effect of a patent provided for in section 42 of PA 1992. Those limitations relate to:■ acts done privately for non-commercial purposes;■ acts done for experimental purposes;■ the preparation for individual cases in a pharmacy of a

medicine in accordance with a medical prescription;■ the use of the invention on board foreign registered vessels or

aircraft; and■ acts done with a view to satisfying marketing authorisation

requirements for medicinal or veterinary products.

1.18 Are (i) preliminary, and (ii) final injunctions available, and if so, on what basis in each case? Is there a requirement for a bond?

(i) Preliminary injunctions are available from the Irish courts and are granted if the party seeking the injunction establishes that:

of apportionment) for giving effect to its decision as it considers expedient. For declaratory relief in groundless threats proceedings, the plaintiff must be a person aggrieved by such threats.

1.10 If declarations are available, can they address (i) non-infringement, and/or (ii) claim coverage over a technical standard or hypothetical activity?

As noted in question 1.9 (iii), a declaration as to non-infringement may be sought. Such a declaration may be made in respect of the applicant’s proposed activities.

1.11 Can a party be liable for infringement as a secondary (as opposed to primary) infringer? Can a party infringe by supplying part of, but not all of, the infringing product or process?

Yes. Section 41 of the PA 1992 confers on the patent proprietor the right to prevent all parties not having his consent from supplying or offering to supply a person with means, relating to an essential element of the invention, for putting the invention into effect when the party knows, or it is obvious in the circumstances to a reasonable person, that those means are suitable and intended for putting the invention into effect. In such proceedings seeking to prevent the indirect use of an invention, the proprietor may claim an injunction, damages or profits, delivery up or destruction. Where the means supplied are staple commercial products, liability for indirect infringement shall not arise unless the patent proprietor also shows that the supplier induced the person supplied to infringe the patent.

1.12 Can a party be liable for infringement of a process patent by importing the product when the process is carried on outside the jurisdiction?

Yes. Although there is no Irish case law on this point, section 40(c) of the PA 1992 confers on the patent proprietor the right to prevent third parties from, inter alia, importing a product obtained directly by a process which is the subject-matter of the patent.

1.13 Does the scope of protection of a patent claim extend to non-literal equivalents?

The scope of protection is determined by the claims while the description and drawings are used to interpret the claims. It is specifically provided in Irish law that, when interpreting claims, the Protocol on the Interpretation of Article 69 of the European Patent Convention must be applied. The Protocol requires that, in determining the scope of a claim, a balance should be found which combines a fair protection for the patent proprietor with a reasonable degree of legal certainty for third parties as to what is covered by the claims. Due account must be taken of any element which is equivalent to an element specified in the claims.

1.14 Can a defence of patent invalidity be raised, and if so, how? Are there restrictions on such a defence e.g. where there is a pending opposition?

Yes, invalidity may be raised as a defence to infringement proceedings. Issues of validity and infringement are heard in the course of the same proceedings. Validity may also be raised in a stand-alone action for revocation, as well as in groundless threats

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1.21 What other form of relief can be obtained for patent infringement? Would the tribunal consider granting cross-border relief?

In addition to injunctions and damages (or an account of profits) the following reliefs may be sought:(a) an order requiring the defendant to deliver up or destroy any

infringing product;(b) an order requiring that information regarding the origin and

distribution networks of infringing goods be disclosed;(c) an order requiring the dissemination and publication of the

judgment at the defendant’s expense; and(d) costs.Cross-border relief is something that has not been considered by the Irish Courts as of yet.

1.22 How common is settlement of infringement proceedings prior to trial?

Settlement of infringement proceedings prior to trial is very common.

1.23 After what period is a claim for patent infringement time-barred?

A claim for patent infringement is time-barred six years from the date of the first infringing act.

1.24 Is there a right of appeal from a first instance judgment, and if so, is it a right to contest all aspects of the judgment?

In Ireland, leave to appeal is not required. The Court of Appeal has appellate jurisdiction from all decisions of the High Court. The Notice of Appeal can be filed as soon as the order of the High Court is perfected. Appeals are heard on the basis of the documents that were before the High Court and the transcript of the oral evidence. An appeal is a review of the decision and no new evidence may be adduced except in exceptional circumstances.

1.25 What are the typical costs of proceedings to first instance judgment on (i) infringement, and (ii) validity? How much of such costs are recoverable from the losing party?

In Ireland, the cost of proceedings will depend on the complexity of the matter, the length of the trial and amount of pre-trial applications involved. Infringement and validity are dealt with at the same trial.

1.26 For jurisdictions within the European Union: What steps are being taken in your jurisdiction towards ratifying the Agreement on a Unified Patent Court, implementing the Unitary Patent Regulation (EU Regulation No. 1257/2012) and preparing for the unitary patent package? For jurisdictions outside of the European Union: Are there any mutual recognition of judgments arrangements relating to patents, whether formal or informal, that apply in your jurisdiction?

In November 2014, the Irish Government announced that a local division of the Unified Patent Court will be established in Ireland,

(a) there is a serious issue to be tried;(b) damages are not an adequate remedy; and(c) the “balance of convenience” favours an injunction.

When applying for a preliminary injunction, the plaintiff must give a cross-undertaking as to the damages which will be payable to the defendant if the plaintiff loses at full trial.

(ii) Final injunctions are routinely granted if the plaintiff is successful at the trial of the action where there is an act to be restrained on an on-going basis and damages alone are not an adequate remedy.

It is important to bear in mind that preliminary injunctions are equitable remedies which are granted based on equitable principles at the ultimate discretion of the court. The chances of obtaining a preliminary injunction in a pharmaceutical patent case are seen as higher, inter alia because the infringing drug may not yet have hit the market or has only just launched when the application for injunctive relief is made.No, it is not necessary to provide a bond. In the affidavit grounding the motion seeking a preliminary injunction, the plaintiff must provide ‘an undertaking as to damages’ to the court to compensate the defendant in the event that the preliminary is later held to have been wrongly granted. Similarly, in the replying affidavit filed by a defendant to a preliminary injunction, it is usual to agree to give a cross-undertaking as to damages to the plaintiff. This undertaking provides that if the preliminary injunction is refused but the plaintiff later succeeds at trial and is found to have suffered damages, the defendant will abide by any order which the court may make for payment of damages to the plaintiff.

1.19 On what basis are damages or an account of profits assessed?

Damages, as a general rule, are awarded only to compensate the loss suffered as a result of the infringement. In assessing the appropriate ‘quantum’ to be awarded, a court will therefore seek to place the plaintiff in the same financial position as he would have been in had the infringement not taken place. Loss of profits will, naturally, be central to this determination. The court may also look to the amount which would have been payable by the defendant as a reasonable royalty for the infringing use. Damages are not generally awarded on a punitive basis in infringement actions.An account of profits is based on the principle of restitution (or unjust enrichment). The focus is therefore on the gain made by the infringing party. A successful plaintiff in patent proceedings may seek either damages or an account of profits, but not both.

1.20 How are orders of the court enforced (whether they be for an injunction, an award of damages or for any other relief)?

Where any person is, by a judgment or order, directed to pay any money, to refrain from doing something or to deliver up or transfer any property real or personal to another, the person so directed is bound to obey such judgment or order upon being duly served with the judgment or order. Where there has not been compliance with such an order, the usual enforcement machinery, including orders for sequestration, attachment and committal, may be deployed. Where a judgment or order against a company has been wilfully disobeyed, attachment against the directors/officers of the company and/or sequestration against the property of the directors/officers may be available.

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■ a demand in the State for a product which is protected by the patent is being met by importation other than from a member of the WTO;

■ the establishment or development of commercial or industrial activities in the State is unfairly prejudiced; or

■ a patent owner is unable to exploit his patent without infringing rights deriving from a first patent (but only to the extent necessary for such exploitation and provided that the invention involves an important technical advance of considerable economic significance in relation to the invention claimed in the first patent).

4 Patent Term Extension

4.1 Can the term of a patent be extended, and if so, (i) on what grounds, and (ii) for how long?

It is not possible to extend the duration of a patent; however, a form of ‘extension’ is available in relation to patents for medicinal and plant protection products to which the SPC regime applies. The SPC takes effect from the expiry of the basic patent covering the product for a maximum term of five years from SPC grant or 15 years from the date of authorisation of the product, whichever is earlier.

5 Patent Prosecution and Opposition

5.1 Are all types of subject matter patentable, and if not, what types are excluded?

The PA 1992 expressly provides that the following subject-matter/activities are not patentable ‘as such’:■ a discovery, a scientific theory or a mathematical method;■ an aesthetic creation;■ a scheme, rule or method for performing a mental act, playing

a game or doing business, or a program for a computer; or■ the presentation of information.In addition, the following subject-matter or activities are not patentable in any circumstances:■ an invention, the commercial exploitation of which would be

contrary to public order or morality (in this regard, the mere fact that such exploitation is contrary to law does not of itself render it contrary to public order or morality);

■ a plant or animal variety or an essentially biological process for the production of plants or animals other than a micro-biological process or the products thereof; or

■ a method for treatment of the human or animal body by surgery or therapy and a diagnostic method practised on the human or animal body.

5.2 Is there a duty to the Patent Office to disclose prejudicial prior disclosures or documents? If so, what are the consequences of failure to comply with the duty?

No, there is not.

5.3 May the grant of a patent by the Patent Office be opposed by a third party, and if so, when can this be done?

No. The only means by which to challenge the grant of a patent is by way of revocation proceedings (post-grant).

in the event that the State ratifies the international agreement under which the court is established. A constitutional amendment is required to ratify the Agreement of a Unified Patent Court. No date has been set as of yet by the Irish Government for the constitutional referendum on the Unified Patent Court, but it is anticipated that this will be held in 2018.

2 Patent Amendment

2.1 Can a patent be amended ex parte after grant, and if so, how?

Under section 38(1) of the PA 1992, the patent proprietor may apply to the Controller to amend the specification of the patent, subject to such terms, including advertising, as the Controller sees fit. Where there are already court proceedings in relation to the patent ongoing, then such an application cannot be made to the Controller. An amendment, once made, is deemed to have had effect from the date of the grant of the patent.

2.2 Can a patent be amended in inter partes revocation/invalidity proceedings?

Yes. Section 38(2) of the PA 1992 provides that the court or the Controller, as the case may be, may, in invalidity proceedings, allow the patent proprietor to amend the specification of the patent in such a manner as the court or Controller thinks fit and subject to such terms as to advertising the proposed amendment and as to costs. Again, any such amendment is deemed to have had effect from the date of grant of the patent.

2.3 Are there any constraints upon the amendments that may be made?

Section 38(3) of the PA 1992 provides that any amendment shall be invalid to the extent that it extends the subject-matter disclosed in the application as filed or that it extends the extent of the protection conferred by the patent.

3 Licensing

3.1 Are there any laws which limit the terms upon which parties may agree a patent licence?

Section 83 of PA 1992 renders void any condition in a licence agreement which, directly or indirectly, would prevent or restrict a party to the contract from using a third party’s product or process, or which would require a party to the contract to acquire any product which is not the subject of a patent from a third party, subject to limited exceptions.

3.2 Can a patent be the subject of a compulsory licence, and if so, how are the terms settled and how common is this type of licence?

Yes, the Controller may order the grant of a compulsory licence, provided that the patent has been in existence for three years, on the grounds that:■ a demand in the State for the subject-matter of the patent is

not being met or is not being met on reasonable terms;

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7 Antitrust Law and Inequitable Conduct

7.1 Can antitrust law be deployed to prevent relief for patent infringement being granted?

There has been no case-law in Ireland on this issue. No Irish court has ever refused to grant relief for infringement on the basis that to grant relief would give rise to a breach of competition law. Nevertheless, Irish patent law is subject to EU and national competition law, so it is possible that relief could be refused on these grounds in the particular circumstances of an infringement case.

7.2 What limitations are put on patent licensing due to antitrust law?

Please refer to questions 3.1 and 7.1 above.

8 Current Developments

8.1 What have been the significant developments in relation to patents in the last year?

On 8 February 2017, the Minister for Health, Mr. Simon Harris TD, confirmed that the Department of Health will publish a consultation paper on biosimilar drugs in 2017. In a speech delivered at an event organised by the Healthcare Enterprise Alliance, he indicated that one of the proposed changes being considered to increase use of biosimilar medicines in Ireland was to allow for interchangeability with biologic medicines.

8.2 Are there any significant developments expected in the next year?

A Constitutional Referendum allowing for the adoption of the Agreement on a Unified Patent Court is expected to be held in 2018.

8.3 Are there any general practice or enforcement trends that have become apparent in your jurisdiction over the last year or so?

No, there are not.

5.4 Is there a right of appeal from a decision of the Patent Office, and if so, to whom?

It is possible to appeal a decision of the Controller to the High Court. Notice of the appeal must be given within three months of the decision being appealed.

5.5 How are disputes over entitlement to priority and ownership of the invention resolved?

An application can be made to the High Court for a determination as to entitlement to ownership subject to the application being made within two years of the grant of the patent. Disputes as to entitlement to priority typically arise in the context of revocation proceedings.

5.6 Is there a “grace period” in your jurisdiction, and if so, how long is it?

Breaches of confidence and displays at exhibitions are treated as non-prejudicial disclosures provided that they took place not more than six months before the filing date.

5.7 What is the term of a patent?

The duration of a patent is 20 years from its filing date. A 10-year ‘short-term’ patent may be granted in respect of an invention which is new, susceptible of industrial application and not clearly lacking an inventive step.

6 Border Control Measures

6.1 Is there any mechanism for seizing or preventing the importation of infringing products, and if so, how quickly are such measures resolved?

Yes. On 1 January 2014, the European Union (Customs Enforcement of Intellectual Property Rights) Regulations 2013 came into force for the purpose of giving full effect to Regulation (EU) No. 608/2013 of the European Parliament and Council. The latter introduced a number of simplifications and changes to the procedure provided for in EU Regulation 1383/2003 which allows customs authorities to deny entry to and destroy counterfeit and pirated goods in certain circumstances.

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Aoife MurphyWhitneyMoore Solicitors Wilton Park House, Wilton Place Dublin 2Ireland

Tel: +353 1 611 0000Email: [email protected]: www.whitneymoore.ie

Robin Hayes WhitneyMoore Solicitors Wilton Park House, Wilton Place Dublin 2Ireland

Tel: +353 1 611 0000Email: [email protected] URL: www.whitneymoore.ie

WhitneyMoore is recognised as one of Ireland’s leading IP firms and provides clients with a full range of advisory and litigation expertise in all aspects of intellectual property including patents, trademarks, copyright, design and trade secrets. We are active across a broad range of industry sectors including pharma, lifesciences, biotechnology, retail and entertainment & media.

We have significant experience of advising multinationals on patent disputes in the pharma, biotech and medical devices sectors, including trials in multi-jurisdictional patent litigation.

The firm also advises on lifesciences and pharmaceutical regulatory matters in the pharmaceutical, healthcare and lifesciences sector. WhitneyMoore has acted on behalf of parties in many High Court actions claiming trade mark infringement and passing-off, acting amongst others for clients in the pharmaceutical, medical, auto, FMCG and entertainment industries. The firm also advises on a wide variety of other trademark issues including the importation of counterfeit goods and the protection of IP rights.

Aoife is an experienced commercial litigator with a particular emphasis on intellectual property. She advises a wide range of indigenous and multi-national clients on all aspects of intellectual property issues, patents, trademarks, copyright and design-related intellectual property matters. She has acted in many of the patent cases that have come before the Irish courts in recent years. She has been involved in infringement and revocation actions in the pharma, biotech and medical device sectors and concerning electronic point-of-sale systems and vending machine apparatuses.

She has acted for manufacturers and brand owners in trade mark, passing-off and unfair competition litigation. She also represents clients in copyright licensing and ownership disputes.

She sits on the Intellectual Property Committee of the Law Society of Ireland and is a co-author of “Technology & IP Law” (Tottell Publishing/Law Society of Ireland).

Robin practises in commercial litigation with particular emphasis on intellectual property matters. His patent litigation experience includes infringement and revocation actions concerning patents for medical devices, pharmaceuticals and electronic point-of-sale systems.

Robin is also experienced in trade mark law (including comparative advertising) and the law of passing-off, acting on behalf of litigants operating in the FMCG, motor and entertainment industries, including in the country’s leading passing-off case. He has also acted in several High Court breach-of-confidence actions recently.

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Chapter 14

Reinhold Cohn Group

Israel

1.3 Can a party be compelled to disclose relevant documents or materials to its adversary either before or after commencing proceedings, and if so, how?

Parties can be compelled to disclose documents or materials only after the commencement of proceedings. In accordance with Israeli law, discovery only occurs between the plaintiff and the defendant. However, third parties can be ordered by the court to produce documents or materials (subpoena duces tecum), following a motion of a party to the court. Given that Israeli law does not allow general discovery against third parties, disclosure from third parties is limited to specific documents and materials.Usually, requests for discovery are exchanged between the parties without the involvement of the court. However, if any of the parties are dissatisfied with the material that has been disclosed by its adversary (i.e. if the party believes its adversary did not disclose the full scope of material that is in their possession, or if one of the parties refused to disclose any material at all), they can submit with the court a motion to compel discovery. A party may request the other party to provide a comprehensive list of documents that are or were in its possession or control; after such list is disclosed the requesting party may request the inspection of any of the listed documents, although confidential documents may be protected by protective orders given by the court. A party is also entitled to present written interrogatories to the other party, which are answered in the form of an affidavit.

1.4 What are the steps each party must take pre-trial? Is any technical evidence produced, and if so, how?

After a statement of claims is filed, and after discovery proceedings are concluded, the court would usually order each party to file its evidence prior to the trial, through affidavits from witnesses and through written expert opinions.Usually, the plaintiff is the first to submit its evidence, followed by the defendant. It is common for a plaintiff to motion for permission to file evidence in reply to the defendant’s evidence.

1.5 How are arguments and evidence presented at the trial? Can a party change its pleaded arguments before and/or at trial?

As stated above, evidence is usually filed pre-trial through written affidavits and expert opinion, which effectively constitute direct examination on behalf of each of the parties. The trial is, in fact, the stage of cross-examination which occurs after all the evidence has been filed.

1 Patent Enforcement

1.1 Before what tribunals can a patent be enforced against an infringer? Is there a choice between tribunals and what would influence a claimant’s choice?

In Israel, patents are governed by the Patents Act 5727-1976 (“the Patents Act”), as well as by various regulations relating to patents. Israel has no specialist patent court, therefore patent infringement proceedings may be brought before any district court, Israel’s highest court of first instance. The district courts are not specialised patent/intellectual property courts, although some district judges have acquired expertise through experience. Each of the six district courts has local (venue) jurisdiction within its district. The venue rules allow for significant flexibility in the choice of forum (as the claim may be filed in any district in which the infringement occurred, as well as in the district in which the defendant resides or does business).

1.2 What has to be done to commence proceedings, what court fees have to be paid and how long does it generally take for proceedings to reach trial from commencement?

To commence proceedings, a statement of claim must be filed with the district court having local jurisdiction. The statement of claim must contain, at a minimum, facts that, subsequently proven, establish the plaintiff’s claims against the defendant. After the defendant is served with the statement of claim, they must respond with a statement of defence within 30 days. The plaintiff then has the right to respond to the defendant’s statement of defence, but they are not obligated to do so.The filing of a statement of claim entails the payment of a court fee that is, in general, a nominal amount of 2.5% (two-and-a-half per cent) of the amount of the claim up to NIS 23,924,999 and 1% (one per cent) of the remainder of the amount of the claim, with no cap. Half of the fee is paid on the date of, and is conditional on, the filing of the statement of case, while the other half is paid up to 20 days before the trial. The trial, which is the phase of the procedure where cross-examination is heard before a judge, usually occurs within two to four years of the commencement of proceedings.

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(iii) An action for a declaratory judgment confirming that the performance of an act in relation to a product or a process would not infringe a patent is rarely brought before Israeli courts. Before filing the motion to the court, the applicant must first fail to obtain a declaration of non-infringement from the patent owner or exclusive licensee.

Prior to petitioning the court for a declaratory judgment of non-infringement, the applicant must reveal to the patent-holder the full details of the product or process they plan to use.

1.10 If declarations are available, can they address (i) non-infringement, and/or (ii) claim coverage over a technical standard or hypothetical activity?

(i) As detailed above, courts in Israel may grant an applicant with a declaration that a certain action is non-infringing.

(ii) It is unlikely that the court will give a judgment regarding hypothetical activity.

1.11 Can a party be liable for infringement as a secondary (as opposed to primary) infringer? Can a party infringe by supplying part of, but not all of, the infringing product or process?

It is possible that a party will be held liable for infringement as a secondary infringement, as the Israeli courts recognise joint tortfeasorship (such as in cases of aiding or inducing infringement); joint tortfeasors are then jointly and severally liable. Liability as joint tortfeasors is based on the provisions of the general Torts Ordinance concerning joint tortfeasors.CA 1636/98 Rav Bariach Ltd. v. Havshush Car Accessories Trading House (1987) Ltd. (Rav Bariach), 55(5) (P.D. 337 [2001] at 352) also recognised a new cause of action for procuring patent infringement. The elements of such cause of action are: (1) the components that are marketed by the contributing infringer form a substantial part of the patented invention; (2) the contributing infringer knew, or should have known due to the circumstances of the case, that the components fit exactly to a combination that would infringe the patent, and that they would be used to do so; and (3) the sold component is not a basic commercial product that fits substantial non-infringing use.

1.12 Can a party be liable for infringement of a process patent by importing the product when the process is carried on outside the jurisdiction?

Yes, a party can be held liable for infringement of a process patent by importing a product even when the process is carried on outside the jurisdiction. This arises from both section 50 of the Patents Act, which provides that the protection of a process patent shall also extend to the direct product of the process, as well as from the definition of “exploitation of an invention”.

1.13 Does the scope of protection of a patent claim extend to non-literal equivalents?

Yes, section 49(a) of the Patents Act recognises infringement not only as “literal infringement” but also as taking the “essence of the invention” that is the subject of the patent – considering what is defined in the claims.The question of what is “essence of the invention” is a legal question decided by the courts based on the evidence brought by the parties.

During the trial hearing, each party is entitled to cross-examine the other party’s witnesses and experts; after the cross-examination, each of the parties can conduct a redirect examination, but there is no obligation to do so.

1.6 How long does the trial generally last and how long is it before a judgment is made available?

Trials normally last for at least several days, although there are exceptions either way. In a simple case, the trial may last for one day only, whereas in highly complex cases the trial can require several days spread over several weeks or even more than that. Written summations are exchanged after the trial, although there are incidents where oral summations are scheduled. Usually, the plaintiff is the first to file its summation, followed by the defendant. After receiving the defendant’s summations, the plaintiff is entitled, but not obligated, to file summations in reply. Following the summations, it will usually take a judge at least several months to issue a written judgment detailing the reasoning behind their decision.

1.7 Are judgments made available to the public? If not as a matter of course, can third parties request copies of the judgment?

As a rule, after a final judgment has been made in court, it becomes available online for public access. The exception to the rule is when the proceedings were conducted in chambers or where the court issued protective orders. In order to view the full docket of the case, third parties must make a request with the court; the request is usually granted unless there is a reasonable explanation as to why it should not be.

1.8 Are there specialist judges or hearing officers, and if so, do they have a technical background?

There are no specialist judges with respect to patents. However, section 130 of the Israeli Civil Law Procedure Regulations 5744-1984 provides that the court has the authority to appoint an independent expert who will submit an opinion as a court-appointed expert. The opinion of a court-appointed expert overrules any expert opinions brought by the parties, unless decided differently by the court.In addition, the Patents Act provides the courts with the authority to appoint a scientific advisor (assessor) to assist the court in assessing scientific evidence. The Supreme Court has clarified that the scientific advisor has a role beyond assistance in obtaining evidence, but also may opine on substantive professional questions, though the advisor may not be involved in the process of passing the judicial decision, which is solely the responsibility of the court. Usually, courts prefer to appoint experts under the Civil Law Procedure Regulations, instead of scientific advisors under the Patents Act.

1.9 What interest must a party have to bring (i) infringement, (ii) revocation, and (iii) declaratory proceedings?

(i) In infringement cases, the plaintiff must be the registered owner of the patent or a registered exclusive licensee.

(ii) In revocation cases, the applicant need not have any interest, and thus could be any person or legal body. It is important to note that revocation proceedings are brought before the Patent Registrar and not before the court.

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opponent or to third parties in case the applicant loses the main trial.

(ii) In accordance with section 183(a) of the Patents Act, final injunction is the main remedy that is available to the plaintiff of a successful infringement action. While the Israeli Copyright Law, 2007, follows the decision in the U.S. case of eBay, Inc. v. MercExchange, L.L.C. and stipulates the court’s express power not to grant a permanent injunction if it finds reasons not to do so, that is not so for patents.

1.19 On what basis are damages or an account of profits assessed?

Israeli courts have broad discretion when deciding upon damages. Section 183 of the Patents Act provides a non-exhaustive list of considerations courts may consider when calculating damages: the direct damage caused to the plaintiff; the extent of the infringement; the profits that the infringer derived by the act of infringement; and reasonable royalties that the infringer would have had to pay had he been granted a licence to exploit the patent to the extent to which the infringement was committed.The list of considerations a court may consider when calculating damages has been expanded through case law; the added considerations include: scope and duration of the infringement; the extent of the commercial success enjoyed by the infringing products; the commercial success that the patented products could have enjoyed but for the infringement; the extent to which the patented products were imitated; the effect that the infringing products had on the market and on the price of the patented products and the anguish caused to the patent-holder; and the type of the patented product (whether sold alone or with other products).If the infringement occurred after the patent owner or exclusive licensee issued a warning to the infringer, the court may order the infringer to pay additional punitive compensation which may not exceed the amount of actual damages.

1.20 How are orders of the court enforced (whether they be for an injunction, an award of damages or for any other relief)?

Injunction orders may be enforced through the Israeli Contempt of Court Ordinance, 1929, which provides the court with the authority to punish or imprison any person who does not comply with the court’s injunctions. Damages are enforced through writs of execution.

1.21 What other form of relief can be obtained for patent infringement? Would the tribunal consider granting cross-border relief?

Although relief of delivery up and deconstruction of the infringing products is not stipulated by Israeli patent legislation, it may still be granted by the court. However, if the defendant manages to show that the product can be modified to avoid infringement, delivery up may not be granted by the court.If an appropriate plea is included in the statement of claims, the defendant may be ordered to provide the plaintiff with a list of suppliers of the infringing products.Cross-border relief is not granted, as the general view is that courts do not have jurisdiction to give judgment over an infringement that took place outside of Israel.

1.14 Can a defence of patent invalidity be raised, and if so, how? Are there restrictions on such a defence e.g. where there is a pending opposition?

In an infringement action, a defence of patent invalidity may be raised on any ground on which the patents may be opposed. If the court accepts the invalidity defence, the patent will be revoked. Invalidity arguments may also be decided by the Patents Office, either during pre-grant opposition or during a post grant revocation action.

1.15 Other than lack of novelty and inventive step, what are the grounds for invalidity of a patent?

Patent claims may be held invalid for: (1) lack of novelty; (2) lack of inventive step; (3) lack of utility; (4) non-susceptibility to industrial application; (5) non-patentable subject matter (the invention not being a “product” or a “process”, or not being “in any technological field”); and (6) falling within the two statutory exceptions, namely (i) procedures for therapeutic treatment on the human body, and (ii) new varieties of plants or animals, except microbiological organisms not derived from nature.

1.16 Are infringement proceedings stayed pending resolution of validity in another court or the Patent Office?

The district court has jurisdiction to decide over infringement claims, including over infringement cases where an invalidity defence has been raised. However, it is important to note that claims of invalidity can be brought independently of an infringement case before the Patent Registrar; and in cases where there are invalidity proceedings before the Registrar, the court may stay the proceeding before such, or may order the Patents Office to stay the proceedings before the latter.

1.17 What other grounds of defence can be raised in addition to non-infringement or invalidity?

The grounds of defence that can be raised in infringement proceedings are not limited to an exhaustive statutory list. Among the additional defences that are available to the defendant are defence of limitations period, laches (delay in bringing suit), equitable estoppel due to reliance on the patent’s owner (or the patent’s exclusive licence-holder), representation and lack of title or standing to sue, and exhaustion.

1.18 Are (i) preliminary, and (ii) final injunctions available, and if so, on what basis in each case? Is there a requirement for a bond?

(i) Preliminary injunctions may be granted by the courts if the plaintiff successfully shows: that there is prima facie evidence to support the plaintiff’s claims of infringement; that the balance of convenience is in favour of the plaintiff, i.e. that the possible damages that may be caused to the plaintiff if the preliminary injunction is not granted are greater than the damages that might be caused to the defendant and third parties if the preliminary injunction is granted; and that the motion for preliminary injunction was made diligently and in good faith.

When filing for a preliminary injunction, the applicant must provide guarantees in order to ensure compensation to the

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2.2 Can a patent be amended in inter partes revocation/invalidity proceedings?

As a rule, yes; however, section 70(a) of the Patents Act provides that if an application for the amendment of a patent is submitted while proceedings for an infringement or for the revocation of that patent are pending before the Court, the Registrar shall hear the application only with the Court’s permission.

2.3 Are there any constraints upon the amendments that may be made?

Yes, section 66 of the Patents Act provides that the Registrar shall permit an amendment only if it does not broaden the scope of claims in the specification or does not add anything to the specification, which in essence was not included in it from the start.

3 Licensing

3.1 Are there any laws which limit the terms upon which parties may agree a patent licence?

The terms upon which parties may agree a patent licence may be limited by the application stipulated by the Antitrust Law, 5748-1988.

3.2 Can a patent be the subject of a compulsory licence, and if so, how are the terms settled and how common is this type of licence?

Yes, if it has been three years since the patent was granted or four years since the patent application was submitted, whichever is later, and the Registrar concluded that a patent-holder has abused his monopoly (i.e. that the full demand for the product is not satisfied in Israel on reasonable terms; or that the conditions that the patent-holder made for supplying the product or for granting a licence for its production or use are not fair under the circumstances of the case, do not take account of the public interest and arise essentially out of the existence of the patent), he may grant a licence to exploit the invention that is the subject of the patent to a person who applied therefor in the prescribed manner and paid the prescribed fee.In addition, if a patented invention (hereafter: “later invention”) cannot be exploited without infringing the patent on an invention, for which the patent application date was earlier (hereafter: “earlier invention”), the Registrar may – if the patent-holder of the later invention so requested – grant them a licence to exploit the earlier invention to the extent necessary for the exploitation of the later invention, provided that the later invention incorporates an important technological innovation of great economic value.This type of licence is extremely rare, and has not been given for over 20 years.

4 Patent Term Extension

4.1 Can the term of a patent be extended, and if so, (i) on what grounds, and (ii) for how long?

(i) A patent for a pharmaceutical (“Substance”) product or a medical device that requires marketing authorisation may be eligible for term extension if it includes claims directed to

1.22 How common is settlement of infringement proceedings prior to trial?

The majority of patent infringement cases are not settled prior to trial and are resolved in court. However, because few patent infringement cases are initiated in Israel (10 or fewer per year), it is hard to ascribe the description of being “common”.

1.23 After what period is a claim for patent infringement time-barred?

A seven-year limitation period on infringement claims commences on the date when the cause of action accrued. However, if the claims against the defendant include deception, the limitation period will begin when the plaintiff becomes aware that the deception occurred. And in instances where the plaintiff, for reasons over which they did not and could prevent or control, had no knowledge of the cause of action, the limitation period runs from when the plaintiff had or should have had knowledge of the cause of action.

1.24 Is there a right of appeal from a first instance judgment, and if so, is it a right to contest all aspects of the judgment?

Yes, there is a right; after final judgment is given in the district court, a party that considers itself aggrieved by the decision is entitled to appeal to the Supreme Court. However, a leave to appeal is needed to contest an interim decision.

1.25 What are the typical costs of proceedings to first instance judgment on (i) infringement, and (ii) validity? How much of such costs are recoverable from the losing party?

The cost of proceeding to first judgment on infringement or validity can vary significantly among cases due to factors such as scope and complexity of the case and numbers of experts and witnesses that are needed. Average cost is estimated to be typically between USD $100,000 and $1,000,000, although it may be higher.

1.26 For jurisdictions within the European Union: What steps are being taken in your jurisdiction towards ratifying the Agreement on a Unified Patent Court, implementing the Unitary Patent Regulation (EU Regulation No. 1257/2012) and preparing for the unitary patent package? For jurisdictions outside of the European Union: Are there any mutual recognition of judgments arrangements relating to patents, whether formal or informal, that apply in your jurisdiction?

This is not applicable in Israel.

2 Patent Amendment

2.1 Can a patent be amended ex parte after grant, and if so, how?

Yes, section 65 of the Patents Act provides that a patent-holder may apply to have the patent specification amended for the sake of clarification, to eliminate a mistake in it or to restrict the claims. In addition, see question 2.3 below. It is important to note that after the Registrar permits the amendment, any person may oppose the amendment within a three-month period.

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5.2 Is there a duty to the Patent Office to disclose prejudicial prior disclosures or documents? If so, what are the consequences of failure to comply with the duty?

Section 18a of the Patents Act provides that, until the patent is accepted, the patent applicant must keep the Patent Office informed of any publications or documents that were available to the public prior to the date of the application, known to the applicant and directly connected to the invention, as well as publications or documents on which patent authorities in foreign states relied on when examining the corresponding applications.Failure to comply with this duty may result in the patent being revoked or not granted at all; a licence to exploit the patent being given to any person who desires it; the patent’s term being shortened and the court may impose a fine on the person or legal body who did not fulfil the duty.

5.3 May the grant of a patent by the Patent Office be opposed by a third party, and if so, when can this be done?

The Patents Act provides that any person may, within three months after the date of publication of acceptance of the application, oppose the grant of a patent by written notice to the Registrar on the following grounds: (1) there is a reason, because of which the Registrar had the authority to refuse to accept the patent application; and (2) the invention is not patentable under section 4(2) of the Patents Act (namely, due to public use; this is because the Patents Office is not required to examine public use); the opponent, and not the applicant, is the owner of the invention.Opposition proceedings are held before the Patents Registrar.

5.4 Is there a right of appeal from a decision of the Patent Office, and if so, to whom?

Yes, section 174 of the Patents Act provides that decisions of the Patents Office may be appealed to certain district courts. Final decisions may be appealed by right, and appeal on non-final decisions requires leave.

5.5 How are disputes over entitlement to priority and ownership of the invention resolved?

Disputes over entitlement to ownership may be resolved before the courts; they may also be brought up in actions submitted with the Patents Registrar. Such disputes may also be decided during oppositions before the Patents Office.Disputes over entitlement to priority may be resolved during infringement proceedings or during proceedings before the Patents Office (oppositions and revocation actions).

5.6 Is there a “grace period” in your jurisdiction, and if so, how long is it?

There is a grace period that applies only in certain conditions. The Patents Act provides that in the following incidents the publications will not affect the rights of the owner of the invention:(1) if it is proved that the material that was published had

been obtained from the owner of the invention or from his predecessor in title and was published without his consent, and if the patent application was submitted within a reasonable time after the applicant learned of the publication;

any of the following: (1) a Substance per se; (2) a process for manufacture of a Substance; (3) use of a Substance; (4) a pharmaceutical preparation containing a Substance; (5) a process of manufacture of a pharmaceutical preparation containing a Substance; or (6) a medical device that requires marketing authorisation in Israel.

The Registrar shall not grant an extension order, unless the following conditions have been met:(1) the material, the process for its production or its use, the

medical preparation that incorporates the Substance or the process for its production, or the medical equipment was claimed in the basic patent and the basic patent remains in effect;

(2) in respect of a medical preparation – a medical preparation that incorporates the Substance is registered in the Register of Medical Preparations according to section 47A of the Pharmacists Ordinance [New Version] 5741-1981 (hereafter: “the Pharmacists Ordinance”);

(3) the registration as aforesaid in paragraph (2) is the first registration that enables the Substance to be used in Israel for medical purposes;

(4) no prior extension order was granted in respect of the basic patent or in respect of the Substance;

(5) if a marketing permit was granted in the United States – the reference patent was also extended in the United States, and it remains in effect;

(6) if a marketing permit was granted in a recognised European country – the reference patent was also extended in the same country, and it remains in effect; and

(7) if marketing permits were granted in the United States and at least on recognised European country – the reference patent was also extended in the United States and in the recognised European country, and it remains in effect.

(ii) As a rule, the duration of the Extension Order may not exceed five years. The exact term will be determined according to the earliest of: ■ The shortest duration of extension granted in the US and

Recognised European Countries. ■ Fourteen years from the earliest marketing approval

in the US or in any one of the Recognised European Countries (Italy, Britain, Germany, Spain, and France).

■ The shortest expiry date, after extension, of any of the reference patents in the US or the Recognised European Countries.

5 Patent Prosecution and Opposition

5.1 Are all types of subject matter patentable, and if not, what types are excluded?

The Patents Act provides that a product or a process in any field of technology is patentable. However, the following subjects are excluded by the Patents Act:(1) a procedure for a therapeutic treatment on the human body;

and(2) new varieties of plants or animals, except microbiological

organisms not derived from nature. In addition, low-level cases suggest that mere ideas, business methods, computer algorithms and software are also excluded.

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8 Current Developments

8.1 What have been the significant developments in relation to patents in the last year?

The Patent Law has not changed over the last year. However, the Patent Office has issued several updates to current practice which are highly relevant to patent prosecution on both the formal and substantive levels. For example:■ The Swiss-type claim format is no longer permissible. The

only permissible “use” format is the “product for use” format.■ A response to an Office Action has to be filed within four

months from the date of the action. Extensions of up to four months (previously six months) are available upon payment of the prescribed fee, to a total accumulated period of extensions throughout the examination of an application of no more than 12 months (previously 15 months).

■ As a rule, in case the set of claims includes multiple inventions, the Examiner will search and examine the first invention, unless instructed differently. It is not possible to overcome an Examiner’s objection raised in connection with the first invention, by replacing the examined claims by a set of claims directed to a different invention, whether or not this different invention was originally claimed.

8.2 Are there any significant developments expected in the next year?

We do not know of any expected changes to be made in the next year. However, Patent Regulations relating to Patent Term Extension are expected soon.

8.3 Are there any general practice or enforcement trends that have become apparent in your jurisdiction over the last year or so?

The main trend may be to shorten and render concise the period of examination of patent applications. This is revealed not only in the shortening of the number of extensions that may be obtained, but also in the broadening of the circumstances defined for refusal of patent applications.

AcknowledgmentThe authors thank assistant author, Ms. Ayala Herzog, Adv., for her most valuable assistance.

(2) (a) the publication was the owner of the invention or his predecessor in title in one of the following circumstances:

(i) display at an industrial or agricultural exhibition in Israel or at a recognised exhibition in one of the Member States, of which official notice reached the Registrar before it was opened;

(ii) publication of a description of the invention at the time of said exhibition; and

(iii) use of the invention for the purposes of the exhibition and at the place of the exhibition.

(b) the publication was by use of the invention, even without its owners’ consent, at the time of the exhibition, at the place of the exhibition or outside it, on condition that the patent application was submitted within six months after the exhibition opened; and

(3) publication was by way of a lecture by the inventor before a scientific society or by publication of the lecture in official transactions of the society, on condition that notice of the lecture reached the Registrar before it was delivered and that the patent application was submitted within six months after the publication.

5.7 What is the term of a patent?

The term of a patent is 20 years from the date the patent application (disregarding the priority date, if earlier). See question 4.1 above, regarding patent term extensions. Patent Term Adjustments are not available.

6 Border Control Measures

6.1 Is there any mechanism for seizing or preventing the importation of infringing products, and if so, how quickly are such measures resolved?

At present, border control measures for patents do not exist in Israel.

7 Antitrust Law and Inequitable Conduct

7.1 Can antitrust law be deployed to prevent relief for patent infringement being granted?

As a rule yes, but case law is scarce.

7.2 What limitations are put on patent licensing due to antitrust law?

See question 3.1 above.

Reinhold Cohn Group Israel

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el

Eran Bareket Gilat, Bareket & Co., Attorneys at Law26A Habarzel St.Tel-Aviv 6971037Israel

Tel: +972 3567 2000Email: [email protected]: www.rcip.co.il/en/gilat-bareket/

Ronnie Benshafrut Reinhold Cohn & Partners, Patent Attorneys26A Habarzel St.Tel-Aviv 6971037Israel

Tel: +972 3710 9333Email: [email protected]: www.rcip.co.il/en

Adv. Eran Bareket is a Senior Partner of Gilat, Bareket & Co., Reinhold Cohn Group. He holds an LL.B. degree (cum laude), 1990, from Tel Aviv University. Eran’s main field of expertise is litigation of intellectual property rights, unjust enrichment and competition law, as well as complex litigations, particularly those involving issues of technology and management of multi-jurisdiction IP litigations. Eran has vast experience appearing before Israeli courts at all levels, as well as before the Patents, Designs, and Trademarks Registrar. He is well-versed in the fields of: IP; High Technology; Technology Transfer, Competition Law; Agency and Distributorships; Regulatory Law (Pharmaceuticals and Medical Devices); the Defence and Homeland Security Industry; and Governmental Companies. Eran was appointed to be the consultant for Intellectual Property matters to the Accountant General’s Division of the Ministry of Finance of the State of Israel.

Eran is continuously commended personally by leading international guides.

Reinhold Cohn Group is the largest, earliest established intellectual property firm in Israel, offering premier intellectual property expertise in filing, prosecution, renewals, protection, oppositions, opinions, due diligence, freedom to operate, enforcement, litigation, licensing, commercialisation and evaluation, portfolio management and strategic counselling in all areas of IP such as patents, trademarks, designs, copyright, open source, plants breeders’ rights, trade secrets, etc.

The Group includes the patent attorneys firm Reinhold Cohn & Partners and the law firm Gilat, Bareket & Co. The synergism of patent attorneys experienced in a diverse spectrum of technical and scientific disciplines working alongside legal professionals creates a unique and effective platform for maximising returns of a client’s intellectual property assets by securing optimal protection. Reinhold Cohn Group and its team of professionals are internationally renowned for excellence and continually ranked amongst the top tiers in leading international and local guides.

Dr. Ronnie Benshafrut is a Patent Attorney and Senior Partner, Co-Head of the Life Science & Chemistry Department and is in charge of Patent Term Extension & Nanotechnology Practice. Ronnie holds a Ph.D. in Organic Chemistry, 1996 and a B.Sc. degree in Forensic Medicine, both from City University of New York. He has experience in all fields of organic chemistry, including: synthetic; analytical; quantification; forensic analysis, including residue analysis, synthesis and detection of drugs and poisons; drug combinations; explosives; forensic DNA analysis; organic mono-layers; surface chemistry and chemistry of molecular-controlled semiconductors; construction of surface bound mono-layers and multi-layers; and reductive solids and charged multi-layers including preparation, analysis and utility. Ronnie is a co-author of the chapter on PTE in Israel of the book Patent Term Extensions – Erganzende Schutzzertifikate, a manual which comments on the relevant statutory provisions and the relevant case law. He is personally commended in the prestigious IAM Patent 1000 ranking.

Reinhold Cohn Group Israel

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Chapter 15

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Japan

is generally each party’s responsibility to collect and submit evidence which it considers necessary to prove its case or rebut the case of its adversary. However, under Article 105 of the Patent Act, the court may, upon the motion of a party, order the other party to produce documents that are required to prove the alleged infringement or to calculate damages. In addition, under Article 104-2 of the Patent Act, a defendant who denies that specific conditions of an article or process claimed by the plaintiff constitutes alleged infringement is compelled to show evidence that clarifies the specific conditions of its act. Under Article 104, where the patent covers a process for producing a product, where the product was not publicly known prior to the filing of the patent application, the defendant may be compelled to show evidence that its products are produced by a process other than the patented process.

1.4 What are the steps each party must take pre-trial? Is any technical evidence produced, and if so, how?

There is no specifically required pre-trial procedure. Certain pre-trial motions such as Inquiry prior to the Filing of an Action and the Collection of Evidence Prior to the Filing of an Action are available under the Civil Procedure Code (Article 132-2 and Article 132-4). The scope of pre-trial activities is generally documentary.

1.5 How are arguments and evidence presented at the trial? Can a party change its pleaded arguments before and/or at trial?

Arguments and evidence are presented by each party at each court hearing, which takes place once every four to six weeks (see question 1.6), generally based only on documents. A party can change its pleaded arguments unless the court finds that (i) under Article 157 of the Civil Procedure Code, the new argument has been presented after the submission deadline either intentionally or through gross negligence and that allowing the new argument would delay the conclusion of litigation, or (ii) the prior argument is found to constitute an admission of arguments or facts presented by the adversary.

1.6 How long does the trial generally last and how long is it before a judgment is made available?

Intensive hearings are not conducted. It generally takes 12–24 months from the filing of a complaint until a first instance judgment is issued. During this period, a court hearing normally takes place once every four to six weeks. Each court hearing lasts 30–60 minutes. In a patent infringement case, proceedings are managed in accordance with guidelines set out by the court. Courts have

1 Patent Enforcement

1.1 Before what tribunals can a patent be enforced against an infringer? Is there a choice between tribunals and what would influence a claimant’s choice?

Patent rights can be enforced either in the Tokyo District Court, which has exclusive jurisdiction over intellectual property cases in eastern Japan, or in the Osaka District Court, which has exclusive jurisdiction over such cases in western Japan. A defendant’s domicile or the place where the infringement occurred determines which of these courts has jurisdiction. In addition, if the plaintiff seeks monetary damages, the plaintiff’s domicile will determine which of the two courts will have jurisdiction. Provisional injunctions may also be brought in the Tokyo District Court or the Osaka District Court.Patent cases brought before these two courts are heard by their respective Intellectual Property Divisions that specialise in intellectual property cases. Intellectual Property Divisions have a long history going back to the 1960s. The Intellectual Property High Court (“IP High Court”), which is a special branch of the Tokyo High Court, has an exclusive jurisdiction over appeals of patent cases from both the Osaka District Court and the Tokyo District Court.

1.2 What has to be done to commence proceedings, what court fees have to be paid and how long does it generally take for proceedings to reach trial from commencement?

The proceedings commence by filing a complaint with a court of competent jurisdiction. A complaint should set out material facts and arguments that support the merits of each asserted claim. When the complaint is filed, the plaintiff must pay a court fee which varies depending on the amount in dispute. For example, if the plaintiff seeks damages of 50,000,000 yen, the court fee would be 170,000 yen. The amount in dispute for non-monetary remedies, such as injunctive relief, is calculated based on a formula set out by the court. A complaint is then served on the defendant(s) by the court along with the summons. The first court hearing usually occurs four to six weeks after the complaint is filed.

1.3 Can a party be compelled to disclose relevant documents or materials to its adversary either before or after commencing proceedings, and if so, how?

Although Japan does have an extensive American-style discovery system, the law provides for document production in certain cases. It

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adopted a two-phase proceeding format: the court first examines whether the alleged infringement has occurred (stage of infringement examination); and then, if an infringement has been found, the court moves to the second-phase proceedings where the amount of damages are assessed (stage of assessment of damages).

1.7 Are judgments made available to the public? If not as a matter of course, can third parties request copies of the judgment?

Any person desiring to have access to a case record, including a judgment, is entitled to file a request with the clerk of the court, specifying the case number and the names of the parties to the case. However, only an interested party can request a copy of a case record including a judgment. In addition, the courts release on their website certain judgments they consider to carry important precedential value. Selected IP-related judgments are available on the IP Judgment Database on the courts’ websites (in Japanese only) and on the IP High Court website (in both Japanese and English). The Japan Patent Office website also provides, both in Japanese and English, selected appellate decisions against the examiner’s decisions.

1.8 Are there specialist judges or hearing officers, and if so, do they have a technical background?

Judges of the IP High Court and the Intellectual Property Divisions in Tokyo and Osaka District Courts (see question 1.1) are special judges who handle only IP cases. Although they have considerable experience in IP matters, very few have a technical background. Experts with knowledge and experience in relevant fields are asked to participate as technical advisors. The court that hears the case designates the most suitable experts including university professors and researchers (approximately 65% of the total) and researchers of private corporations (9% of the total) on a case-by-case basis. They provide judges and the parties with explanations on technical matters involved in the case, and may participate in proceedings to clarify issues, help examine evidence or assist at settlement conferences. Unlike technical advisors who are assigned to each case, judicial research officials participate in proceedings of all cases relating to IP matters and carry out necessary technical research.

1.9 What interest must a party have to bring (i) infringement, (ii) revocation, and (iii) declaratory proceedings?

(i) To bring an action for infringement, a party must be the owner of a patent or an exclusive licensee whose interest is registered with the Japan Patent Office (senyo-jisshiken-sha). Although jointly owned patents may not be assigned, pledged or licensed without the consent of all of the joint owners, each co-owner has a separate, independent right to bring an infringement suit and seek injunctions based on such co-owner’s interest in the patent. Unregistered exclusive licensees may make demands for monetary damages, but may not seek injunctions (there is some debate on this issue, but no court decision has yet addressed it to date).

(ii) Revocation proceedings are not available through the courts. A party seeking a patent revocation must file a validity challenge with the Japan Patent Office. However, a defendant in an infringement litigation in court can raise invalidity as a defence and, if the judge finds that the patent should be invalidated, the judge will so rule in the decision, and will not allow enforcement of the patent. It has been a general practice in Japan for defendants to raise invalidity defence in infringement litigation and, at the same time, file a revocation proceeding in the Japan Patent Office. It should

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be noted that, under the rule applicable from April 2012, in cases where a defendant files a revocation proceedings in the Japan Patent Office, a request for correction of the patent cannot be filed but only be raised in a Trial for Invalidation proceeding within a limited time period (see question 2.1).

1.10 If declarations are available, can they address (i) non-infringement, and/or (ii) claim coverage over a technical standard or hypothetical activity?

Although filing separate lawsuits to confirm certain status, such as status to file an application of the patent, is possible, declaratory proceedings in patent infringement litigation are not available.

1.11 Can a party be liable for infringement as a secondary (as opposed to primary) infringer? Can a party infringe by supplying part of, but not all of, the infringing product or process?

Yes. The following acts are deemed to constitute patent infringement:■ the manufacture, sale, import, etc., as a business, of a part of

or entire product to be used exclusively for the manufacturing of a patented product or use in a patented process (Article 101-1, 101-4 of the Patent Act); and

■ the manufacture, sale, import, etc., as a business, of a part of or entire product (excluding products widely distributed in Japan) to be used for the manufacture of a patented product or use of a patented process and indispensable for solving a problem by an invention, knowing that such invention is patented and that a part of or the entire product is to be used for the manufacturing, etc. of the invention (Article 101-2, 101-5 of the Patent Act).

1.12 Can a party be liable for infringement of a process patent by importing the product when the process is carried on outside the jurisdiction?

If the patent covers the process for producing a product, importing the product when such process is carried on outside of Japan constitutes patent infringement.

1.13 Does the scope of protection of a patent claim extend to non-literal equivalents?

Yes. Under the doctrine of equivalents, a product or process that does not literally infringe on a claim may still be found to infringe on it if all of the following five requirements are satisfied: (i) the different part is not essential to the invention; (ii) the replacement of such part still achieves the objectives of the claimed invention, as well as the function and effect of the invention; (iii) the replacement of such part would have been obvious to those skilled in the art at the time of the manufacturing or sale of the allegedly infringing product or process; (iv) the allegedly infringing product or process was novel or was not obvious in light of prior art at the time of the filing of the invention; and (v) there are no particular circumstances showing that the allegedly infringing product or process was intentionally excluded from the scope of the claim during prosecution.

1.14 Can a defence of patent invalidity be raised, and if so, how? Are there restrictions on such a defence e.g. where there is a pending opposition?

Patent invalidity can be raised as a defence in a patent litigation lawsuit. It may be raised regardless of whether there is a pending

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multiplied by the amount or number of products actually sold by the infringer; (ii) the profits earned by the infringer; or (iii) the amount equivalent to the royalty to which the patentee would have been entitled. Under the Patent Act, those who infringe on a patent right are presumed to be negligent when committing the infringing act, even if they had no actual knowledge of the existence of the patent. Accordingly, damages start to accrue upon the commencement of the infringing act after a patent is granted.

1.20 How are orders of the court enforced (whether they be for an injunction, an award of damages or for any other relief)?

■ An injunction is enforced by means of an Indirect Compulsory Execution, whereby the court orders the obligor to pay the obligee a certain amount of money that is found to be reasonable for securing performance of the obligation.

■ An order of disposal of products constituting infringement or the removal of facilities used for the infringement is enforced by the measure of the Substitute Execution, whereby the court allows the obligee to execute such disposal or removal as a substitute for the obligor.

■ An award of damages is enforced by the Compulsory Execution where the obligee can seize the assets of the obligor.

1.21 What other form of relief can be obtained for patent infringement? Would the tribunal consider granting cross-border relief?

Together with seeking injunctive relief, a patentee may seek other measures necessary to prevent the infringement, including disposal of products constituting such infringement and removal of facilities used for the infringement. Cross-border relief by the Japanese Court is not available, but a foreign judgment may be enforced if all of the conditions stated in Article 118 of the Civil Procedure Code are met.

1.22 How common is settlement of infringement proceedings prior to trial?

Around 40–50% of cases are settled prior to the first instance judgment.

1.23 After what period is a claim for patent infringement time-barred?

Injunctive relief is available as long as a patent is validly registered and has not expired. A claim to seek monetary damages is time-barred three years after a patentee becomes aware of the infringement and the identity of the infringer, or 20 years after the infringement takes place, whichever comes earlier. In cases where an applicant seeks compensation by sending a warning letter to an alleged infringer after publication of an application, such claim is time-barred three years after a patent is granted. In addition, patentees’ claims for monetary damages equivalent to reasonable royalties based on unjust enrichment grounds are subject to a 10-year statute of limitations.

1.24 Is there a right of appeal from a first instance judgment, and if so, is it a right to contest all aspects of the judgment?

A first instance judgment of the Tokyo District Court or the Osaka District Court can be appealed to the IP High Court, which is the

opposition at the Japan Patent Office. The judge generally instructs the defendant as to when to submit such defence, if at all. An invalidity defence may be dismissed if (i) it has been presented intentionally or through gross negligence after the deadline for doing so and it would delay the proceedings, or (ii) it is submitted solely for the purpose of unreasonably delaying the proceedings.

1.15 Other than lack of novelty and inventive step, what are the grounds for invalidity of a patent?

Other grounds for invalidity include (i) lack of industrial applicability, (ii) insufficiency of disclosure in a written description (lack of enablement), (iii) lack of support of the scope of claim by the descriptions and drawings, (iv) violation of public order, morality or public health, (v) in case of jointly owned application, lack of filing by all the co-owners, and (vi) grant of the patent to a person who is not entitled to it.

1.16 Are infringement proceedings stayed pending resolution of validity in another court or the Patent Office?

No. Although the validity challenge can be raised both in the court and at the Japan Patent Office, under Article 104-4 of the Patent Act, once a judgment of infringement becomes final and binding, a subsequent decision for revocation at the Japan Patent Office has no effect on the earlier final court judgment. Also, if a decision to invalidate a patent at the Japan Patent Office has become final and binding prior to a court’s judgment (i.e., either the patentee did not appeal to the IP High Court, or the IP High Court affirmed the decision of the Japan Patent Office), the patent is deemed never to have existed.

1.17 What other grounds of defence can be raised in addition to non-infringement or invalidity?

Other grounds of defence in addition to non-infringement or the invalidity are: (i) grant of a statutory licence due to a prior user right; (ii) use of the patented invention for experimental or research purposes; and (iii) exhaustion of patent rights. An experimental use defence covers the use of a patented invention in a clinical trial necessary for filing an application for approval of generic drugs. There is some debate over whether the use of a research tool patent constitutes an infringement, but no court decision has yet been rendered on this issue.

1.18 Are (i) preliminary, and (ii) final injunctions available, and if so, on what basis in each case? Is there a requirement for a bond?

A preliminary injunction is available in cases where two require-ments are met; namely, (i) the court finds a prima facie evidence of infringement, and (ii) it is necessary to avoid substantial detriment or imminent danger to the patentee. A bond must be posted. A final injunction may be available where (i) the court finds infringement, and (ii) the infringing activities are still carried on by the defendant or are likely to be carried on.

1.19 On what basis are damages or an account of profits assessed?

The patentee may claim the following damages from the infringer: (i) the profit per product that would have been sold by the patentee

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clarifying ambiguous statements, or (iv) correcting a statement of claims which cites other statement of claims to untie such citation. Furthermore, corrections cannot exceed the scope of disclosure in the application, and may not substantially enlarge or alter the scope of claims. Claims can only be amended to the extent that they are still patentable after the amendments.

3 Licensing

3.1 Are there any laws which limit the terms upon which parties may agree a patent licence?

The Antimonopoly Act limits certain terms in patent licence agreements. For example, terms that restrict prices may violate the Antimonopoly Act and thus may not be included in a patent licence. In addition, a provision requiring the licensee to assign all rights or grant an exclusive licence to the licensor for any improvement attributable to the licensee is also considered to be an antitrust violation. Moreover, restrictions on buyers, raw materials and components or distributors may violate the Antimonopoly Act, if such terms are found to harm fair competitions in the relevant market and no reasonable grounds for such restrictions are found. Additional details and examples of these and other potential violations are discussed in The Guidelines for the Use of Intellectual Property under the Antimonopoly Act issued by the Japan Fair Trade Commission. An English version is available on the JFTC’s website.

3.2 Can a patent be the subject of a compulsory licence, and if so, how are the terms settled and how common is this type of licence?

A compulsory licence may be granted as (i) a statutory non-exclusive licence, or (ii) an awarded non-exclusive licence.A statutory non-exclusive licence is granted if a prior user right is found when a person unknowingly used the invention in its business or in substantial preparations for business prior to the filing of the patent. In cases involving a prior user right, the payment of royalties is not required. Another example could arise when a person unknowingly uses an invalidated patented invention in its business or in substantial preparations for business prior to the registration of the request for a Trial for Invalidation. In such a case, the licensee is required to pay a reasonable royalty.An awarded non-exclusive licence is granted when a person makes a request to a patentee to use the invention that has not been sufficiently and continuously used for three years or longer. If an agreement is not reached between the parties, the person desiring to use the invention may request the Commissioner of the Japan Patent Office for a grant of a non-exclusive licence. The grant would specify the scope of the licence and the amount of the royalty. Another example would be a licence concerning public interests or with dependent inventions. However, awarded non-exclusive licences have rarely been requested.

4 Patent Term Extension

4.1 Can the term of a patent be extended, and if so, (i) on what grounds, and (ii) for how long?

Patents on pharmaceutical products and agrochemicals may be extended for up to five years, subject to regulatory approval in both

exclusive court to hear such appeals. It is the concerned party’s right to contest any and all aspects of the judgment.

1.25 What are the typical costs of proceedings to first instance judgment on (i) infringement, and (ii) validity? How much of such costs are recoverable from the losing party?

The typical costs of proceedings up to a first instance judgment on both infringement and validity include (i) court fees, and (ii) attorneys’ fees. Court fees vary depending on the amount involved in a dispute (see question 1.2). Court fees paid to the court can be recovered from the losing party by filing a petition for determination of such fees. The amount of the attorneys’ fees depends on the complexity of the case and the amount in dispute. Some attorneys charge on an hourly basis in cases involving patent infringement or invalidity, while others charge (i) a fixed initial fee, and (ii) contingent fees payable if their clients prevail. Attorneys’ fees are not recoverable from the losing party. However, the court generally awards approximately 10% of the admitted amount in dispute to the patentee as part of damages.

1.26 For jurisdictions within the European Union: What steps are being taken in your jurisdiction towards ratifying the Agreement on a Unified Patent Court, implementing the Unitary Patent Regulation (EU Regulation No. 1257/2012) and preparing for the unitary patent package? For jurisdictions outside of the European Union: Are there any mutual recognition of judgments arrangements relating to patents, whether formal or informal, that apply in your jurisdiction?

There are no such arrangements in Japan.

2 Patent Amendment

2.1 Can a patent be amended ex parte after grant, and if so, how?

Yes. A patent can be amended after having been granted by filing a request for Correction Trial with the Japan Patent Office. Corrections, limited in scope, can be made on claims, descriptions, or drawings attached to the application (see question 2.3). It should be noted that, under the rule applicable from April 2012, a request for Correction Trial may not be filed while any revocation proceedings or opposition proceedings are pending; however, as an alternative, a patentee can request a correction in a Trial for Invalidation proceeding within a limited time period designated by the examiner.

2.2 Can a patent be amended in inter partes revocation/invalidity proceedings?

A patentee can file a request of correction in a Trial for Invalidation proceeding only within a limited time period designated by the examiner.

2.3 Are there any constraints upon the amendments that may be made?

The scope of correction is limited to (i) narrowing the scope of claims, (ii) correcting errors or incorrect translations, (iii)

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or parties who have the right to obtain the patent. There is no time limitation for the filing of an application for a Trial for Invalidation. A party dissatisfied with a decision to invalidate or maintain a patent is entitled to appeal it to the IP High Court.

5.4 Is there a right of appeal from a decision of the Patent Office, and if so, to whom?

There is a right of appeal from a decision of examiners at the Japan Patent Office under the following circumstances. An appeal must be brought before a panel of administrative judges at the Japan Patent Office.■ An applicant who has received a decision rejecting a patent

application has the right to file a request for a trial challenging such decision of refusal.

■ An interested party (see question 5.3) who is dissatisfied with a decision to grant a patent is entitled to file for a Trial for Invalidation.

■ An interested party who is dissatisfied with a decision to grant an extension of the patent is entitled to file for a Trial for Invalidation of an extended registration.

■ A patentee may file a request for a Correction Trial to seek approval for the correction of the descriptions, claims or drawings in the patent application.

Any appellate decision made by a panel of administrative judges at the Japan Patent Office may be appealed to the IP High Court.

5.5 How are disputes over entitlement to priority and ownership of the invention resolved?

Under Article 74(1) of the Patent Act, a true inventor who has the legitimate right to obtain a patent may file a suit to request an assignment of the patent by the patentee (a false owner). If such transfer is ordered by the court and registered, the patent right at issue is deemed to have belonged to the true inventor from the beginning. A person challenging the ownership of an invention may also file for a Trial for Invalidation with the Japan Patent Office and assert that the patent should be invalidated on the grounds that it has been granted to the wrong person.

5.6 Is there a “grace period” in your jurisdiction, and if so, how long is it?

Yes. There is a six-month grace period in Japan. Either an action against the will of the inventor or an action by the inventor, taken within a six-month period before an application for a patent, may be granted an exception for lack of novelty.

5.7 What is the term of a patent?

A patent expires 20 years after the filing of an application for it. Patents for pharmaceutical products and agrochemicals may be extended for an additional five-year period.

6 Border Control Measures

6.1 Is there any mechanism for seizing or preventing the importation of infringing products, and if so, how quickly are such measures resolved?

Japan Customs (“Customs”) enforces against entries of goods infringing on intellectual property rights at the border. A patentee

cases. A recent decision by the Grand Panel of the IP High Court ruled on the scope of extended patent rights (see question 8.1).

5 Patent Prosecution and Opposition

5.1 Are all types of subject matter patentable, and if not, what types are excluded?

The Patent Act recognises inventions as “highly advanced creations of technical ideas utilising the laws of nature”. Therefore, ideas that do not utilise the laws of nature, such as simple mathematical theories or formulae, are not patentable. Because an invention must be a creation of technical ideas, the mere discovery of living things or non-living substances is not patentable. However, a computer program may be patentable if it expresses information processing by software cooperating with hardware resources. A business method may be patentable if it is implemented by using a computer program. Products of genetic engineering such as genes, vectors, recombinant vectors, proteins, and monoclonal antibodies are patentable.

5.2 Is there a duty to the Patent Office to disclose prejudicial prior disclosures or documents? If so, what are the consequences of failure to comply with the duty?

Under Article 36(4)-2 of the Patent Act, applicants are required to disclose any prior art references known to the applicants at the time of the filing. In addition, the examiner may request the applicant to submit additional prior art references and failure to do so may result in a rejection of the application by the examiner. However, there is no affirmative legal duty to submit prejudicial prior art to the examiner.

5.3 May the grant of a patent by the Patent Office be opposed by a third party, and if so, when can this be done?

The grant of a patent by the Japan Patent Office may be challenged by a third party in (i) an opposition to a granted patent (“Opposition”), or (ii) a Trial for Invalidation, both of which are to be brought before the Japan Patent Office.The Opposition mechanism was once abolished but subsequently re-adopted in 2014, and has been available since April 1, 2015. Any third party who desires to oppose a granted patent can file an Opposition before the Japan Patent Office within six months after the issuance of notice in the Official Gazette for the patent. The grounds for Opposition are the same as the grounds for invalidity (see question 1.15), but the grounds in connection with ownership of a patent such as a false inventorship or violation of joint application by co-owners are excluded. If the examiners at the Japan Patent Office find that a patent should be revoked, a preliminary revocation notice will be given to the patentee. The patentee may then rebut such preliminary notice by submitting an opinion letter and may request to make corrections to the claims, specifications, or drawings of the patent. The patentee is entitled to appeal to the IP High Court against a revocation decision by the Japan Patent Office; however, no appeal can be brought against the decision to maintain the patent.Trial for Invalidation is also a proceeding before the Japan Patent Office to invalidate a patent. However, the standing to file an application for a Trial for Invalidation is limited to interested parties, such as an alleged infringer. The standing to apply for a Trial for Invalidation based on the ownership of a patent is limited to a party

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On March 25, 2016, the Grand Panel of the IP High Court found patent infringement under the doctrine of equivalents. In Japan, a product or process that does not literally infringe on a claim may still be found to infringe on it if the five requirements mentioned earlier are satisfied (see question 1.13). The Grand Panel specifically ruled that the “essential part” of a patented invention in the first requirement of the doctrine of equivalents refers to a characteristic part which constitutes a unique technical idea that cannot be seen in prior art, and which should be found based on the claims, the descriptions and, in particular, the comparison with prior art stated in the descriptions. The Grand Panel also ruled that the fact that the applicant did not describe another structure, which a person ordinarily skilled in the art can easily conceive of as of the filing date as one that is substantially identical to the structure stated in the scope of the claims, cannot be considered to fall under the “special circumstances” in the fifth requirement of the doctrine of equivalents. Lastly, the Grand Panel confirmed that the burden of proof for the first three requirements would be borne by the plaintiff (a person claiming the application of doctrine of equivalents) and the fourth and fifth requirements would be borne by the defendant (a person denying the application of the doctrine of equivalents).

8.2 Are there any significant developments expected in the next year?

No significant developments are expected in the next year. There are no pending cases at the Grand Panel of the IP High Court at this moment (May 2017).

8.3 Are there any general practice or enforcement trends that have become apparent in your jurisdiction over the last year or so?

There have been an increasing number of patent infringement cases with findings of infringement under the doctrine of equivalents. The first requirement (i.e., that “the different part be not essential to the invention”, see questions 1.13 and 8.1) has been the focus of the debate. The determination of what constitutes “the essential part” tends to be an abstract concept, making it more difficult to apply the doctrine. The parties or judges try to deal with the concept by making an analogy to prior art avoid having the interpretation of the essential part of the invention becoming too broad.An additional new trend involves the 2015 amendment to the Patent Act concerning employee inventions. Under the new rule, a corporation may be recognised as an inventor under certain conditions and an employee, on the other hand, may have the right to receive reasonable amount of money or other benefits (“Reasonable Benefits”). The amendment became effective on April 1, 2016 and the Minister of Economy, Trade and Industry issued related guidelines on April 22, 2016 clarifying how to ensure due process to determine the scope of the Reasonable Benefits.

can request Customs to initiate Identification Procedures where Customs detects infringing goods in imports or exports. If such request is filed with Customs, details of the request are published on Customs’ website. When suspected goods are detected, Customs notifies the patentee and the importer of relevant information. Both parties are entitled to have the opportunity to submit their opinions and evidence within 10 working days after receiving a formal “Notification of Initiation Letter”. The patentee may conduct a sample examination on condition that all the requirements for such procedure are satisfied and a bond is posted. Importers, on the other hand, may follow the practice of Voluntary Disposal. Based on the opinions and evidence from both parties, and the opinions from experts who may be appointed by Customs, Customs will determine whether or not the suspected goods infringe on the patent rights. Such determinations are expected to be made within one month. If the decision that the goods infringe on the patent becomes final, Customs may confiscate and destroy the infringing goods.

7 Antitrust Law and Inequitable Conduct

7.1 Can antitrust law be deployed to prevent relief for patent infringement being granted?

Defences based on antitrust laws are rarely raised.

7.2 What limitations are put on patent licensing due to antitrust law?

See question 3.1 above.

8 Current Developments

8.1 What have been the significant developments in relation to patents in the last year?

On January 20, 2017, the Grand Panel of the IP High Court dismissed an injunction suit against the use of certain pharmaceutical drugs that was based on an extended patent right. Under Article 68-2 of the Patent Act, where the duration of a patent right is extended, the scope of such right is limited to the use of the patented invention only for the product which was the subject of the disposition by Cabinet Order under Article 67 (2) which constituted the reason for the extension. The Grand Panel found that the extended patent right is not only enforceable against the product (medicine) identified by the ingredients, quantity, dosage, administration, efficacy, and effects, all of which were set out in the Cabinet Order disposition, but also against products that are substantially identical to that product as medicine. The Panel specifically ruled that even if structures set out by the Cabinet Order disposition have any part different from the product of the alleged infringer, if such different part represents only a slight difference or formal difference on the whole, the extended patent right is enforceable against such product.

Chuo Sogo Law Office, P.C. Japan

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Naoko NakatsukasaChuo Sogo Law Office, P.C.Kohda Building 11th Floor2-10-2 Nishi-Tenma, Kita-ku OsakaJapan

Tel: +81 6 6365 8111Email: [email protected]: www.clo.jp/english

Chuo Sogo Law Office, P.C., is a domestic and international business law firm founded in 1968 by Tsugujiro Nakatsukasa. Within the scope of its corporate, commercial and litigation practices, the firm assists clients with intellectual property matters, including patent, trademark, copyright, and unfair competition matters as well as related litigation and dispute resolution. The firm has three offices in Japan: Osaka; Tokyo; and Kyoto.

Naoko Nakatsukasa is a partner at Chuo Sogo Law Office, P.C., admitted to practise law in Japan and New York. She assists clients with litigation and dispute resolution of intellectual property and general corporate matters, and counsels clients concerning patent, trademark, copyright, design and unfair competition-related issues. She has substantial experience in domestic and international business transactions. Naoko serves as a director and corporate auditor of listed companies in Japan, and as a lecturer at Kyoto University Law School. Her publications include “Legal Consultation on Unfair Competition” (co-author), “Equivalent Infringement and Dismissal of Allegations Advanced out of Time” and “Indirect Infringement on Non-Exclusive Use Products and Exercise of An Injunction”. Naoko graduated from Kyoto University in 1992 and was admitted to the Japanese Bar in 1994. She received an LL.M. degree from Northwestern University School of Law in 2005. Naoko is fluent in both Japanese and English.

Chuo Sogo Law Office, P.C. Japan

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Chapter 16

Agency TRIA ROBIT

Latvia

1.5 How are arguments and evidence presented at the trial? Can a party change its pleaded arguments before and/or at trial?

Arguments are normally submitted in writs, along with supporting evidence, and are discussed later at court hearings. Arguments can be changed, abandoned or supplemented with new points/arguments until the court closes the adjudication on the merits of the matter.

1.6 How long does the trial generally last and how long is it before a judgment is made available?

The trial might consist of several hearings, which may last several months. There are no limits on how long a trial can last, and it is at the sole discretion of the judge to limit the time allocated to each party’s statement. Judgments are usually made within two weeks of the conclusion of a trial; however, in patent matters it may take up to eight weeks to deliver a judgment.

1.7 Are judgments made available to the public? If not as a matter of course, can third parties request copies of the judgment?

Publication of a judgment may only be upon request of the winning party and by court order. Normally, judgments are made available to the public by means of a specialised database once they become final and after all of the personal, commercial and sensitive information has been deleted from the text of the judgment.

1.8 Are there specialist judges or hearing officers, and if so, do they have a technical background?

The court of first instance and the court of appeal both have designated judges to hear patent matters. Such judges, however, do not have a technical background.

1.9 What interest must a party have to bring (i) infringement, (ii) revocation, and (iii) declaratory proceedings?

Infringement proceedings might be brought by a patent owner or a licensee (if the licensee has such right under a licence agreement or with the patent owner’s permission). Revocation action can be brought by any person. It is not necessary to have or prove any interest. Declaratory proceedings are not provided by the law.

1 Patent Enforcement

1.1 Before what tribunals can a patent be enforced against an infringer? Is there a choice between tribunals and what would influence a claimant’s choice?

A patent can be enforced before Riga City Vidzeme Suburb Court (Rīgas pilsētas Vidzemes priekšpilsētas tiesa) as a court of first instance and Riga Regional Court (Rīgas apgabaltiesa) as a court of appeal. Decisions of the lower courts might be reviewed by the Supreme Court (Augstākā tiesa). The claimant does not have any choice between courts as the mentioned courts are designated by the law as specialised courts of exclusive competence over patent enforcement.

1.2 What has to be done to commence proceedings, what court fees have to be paid and how long does it generally take for proceedings to reach trial from commencement?

A written statement of claim must be submitted to the court along with payment of fees to commence proceedings. The standard court fee is €220. On average, it takes six to eight months to reach a trial.

1.3 Can a party be compelled to disclose relevant documents or materials to its adversary either before or after commencing proceedings, and if so, how?

Latvian law does not provide the option of discovery. However, the claimant might request that the defendant (and vice versa) provides relevant documents or materials to the court either before or after commencing proceedings under a procedure for securing evidence provided by the law. In order to apply, an application for securing evidence must be submitted to the court. Such application should describe what evidence needs to be secured and why. Reasons for securing evidence can include the fact that later on it may be problematic or impossible to secure such evidence.

1.4 What are the steps each party must take pre-trial? Is any technical evidence produced, and if so, how?

There are no mandatory steps to be taken before trial. Each party makes their own assessment as to how to prepare for the trial and whether or not to produce any evidence.

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Voldemars Osmans

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1.18 Are (i) preliminary, and (ii) final injunctions available, and if so, on what basis in each case? Is there a requirement for a bond?

Both preliminary and final injunctions are available. The basis for any injunction is assessed in each case individually depending on the merits and taking into account the evidence submitted and the facts proved. A bond might be requested by a court in case of a preliminary injunction. A bond is not (and cannot be) required for enforcement of a final injunction(s) when the judgment is final and cannot be appealed further.

1.19 On what basis are damages or an account of profits assessed?

According to the law, it is possible to request the following forms of damages: direct or indirect losses, including lost profits; and a licence fee or unfair (illegally gained) profits. The law also provides a possibility to request compensation for moral damages. The amount of such damages is determined solely on the basis of the evidence submitted by the parties. Punitive damages are not permitted.

1.20 How are orders of the court enforced (whether they be for an injunction, an award of damages or for any other relief)?

There is no special procedure for the enforcement of court orders in patent cases and a general procedure of enforcement of court judgments through court bailiff should be used. Preliminary enforcement is not available; enforcement of a judgment is possible as soon as the judgment becomes final.

1.21 What other form of relief can be obtained for patent infringement? Would the tribunal consider granting cross-border relief?

Besides from the compensation of damages and moral damages, a court may also order the defendant (infringer) to stop using the invention and prohibit any further use, including withdrawal of the infringing products from the market and distribution channels. The court judgment, in part or in full, may also be published in newspapers and other mass media.

1.22 How common is settlement of infringement proceedings prior to trial?

There is no data on this.

1.23 After what period is a claim for patent infringement time-barred?

The time period for the submission of a claim to a court for a patent infringement is three years from the time when the aggrieved party knew or should have known that his or her rights had been violated.

1.24 Is there a right of appeal from a first instance judgment, and if so, is it a right to contest all aspects of the judgment?

Yes, first instance judgments can be appealed in part or in full, involving all aspects of the case or just some. An appeal might be

1.10 If declarations are available, can they address (i) non-infringement, and/or (ii) claim coverage over a technical standard or hypothetical activity?

Declarations are not available.

1.11 Can a party be liable for infringement as a secondary (as opposed to primary) infringer? Can a party infringe by supplying part of, but not all of, the infringing product or process?

A party might be found secondarily liable if the activity of that party is recognised as preparation for the unlawful utilisation of a patent, or its services are utilised for conducting infringement or it is party to the infringement. Supply of part of an infringing product might entail liability, especially if knowledge of the supplier can be proved.

1.12 Can a party be liable for infringement of a process patent by importing the product when the process is carried on outside the jurisdiction?

Yes, a process patent is deemed to be infringed by an imported product where the relevant process is carried on outside the jurisdiction.

1.13 Does the scope of protection of a patent claim extend to non-literal equivalents?

Yes, it does.

1.14 Can a defence of patent invalidity be raised, and if so, how? Are there restrictions on such a defence e.g. where there is a pending opposition?

A defendant may bring a counter-claim to court regarding the invalidation of the patent by submitting a statement of claim to the same court until the court closes the adjudication on the merits of the matter. A pending opposition does not preclude filing of a claim for invalidation of the patent.

1.15 Other than lack of novelty and inventive step, what are the grounds for invalidity of a patent?

A patent can be invalidated on the following grounds: industrial applicability; the fact that it is a non-patentable subject matter; where use of the invention is in conflict with public order or the principles of morality accepted in society; insufficiency of disclosure; added subject matter to the patent; or if entitlement to the patent is disputed.

1.16 Are infringement proceedings stayed pending resolution of validity in another court or the Patent Office?

Normally, yes.

1.17 What other grounds of defence can be raised in addition to non-infringement or invalidity?

Other grounds of defence are as follows: exhaustion; rights of fair prior use; personal needs; non-commercial purposes; and experimental or investigative activities.

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3.2 Can a patent be the subject of a compulsory licence, and if so, how are the terms settled and how common is this type of licence?

The Patent Law provides for a compulsory licence when the patent owner does not use the invention and there is a public interest in use of the invention. To the best of our knowledge, there have not been any compulsory licences granted in our jurisdiction so far.

4 Patent Term Extension

4.1 Can the term of a patent be extended, and if so, (i) on what grounds, and (ii) for how long?

The only extension available is the extension under the European SPC regulations in relation to pesticides and pharmaceuticals.

5 Patent Prosecution and Opposition

5.1 Are all types of subject matter patentable, and if not, what types are excluded?

The following shall not be considered inventions:■ discoveries, scientific theories and mathematic methods;■ aesthetic creations;■ schemes, intellectual activities, rules and methods for

commercial activities and games, as well as computer programs;

■ methods for the presentation of information;■ inventions whose making public or use is in conflict with

public order or the principles of morality accepted in society;■ plant or animal varieties or basic biological methods for the

acquisition of plant or animal varieties;■ biotechnological inventions pertaining to human cloning,

modification of the genetic identity of human beings in germ cells, utilisation of human embryos for industrial or commercial purposes, methods for modifying the genetic identity of animals likely to cause them suffering without any substantial medical benefit to people or animals, as well as animals resulting from such methods; and

■ a human body in different stages of formation and development and a simple discovery of one of its elements, including the sequence or partial sequence of a gene.

5.2 Is there a duty to the Patent Office to disclose prejudicial prior disclosures or documents? If so, what are the consequences of failure to comply with the duty?

There is no duty to disclose.

5.3 May the grant of a patent by the Patent Office be opposed by a third party, and if so, when can this be done?

No; however, an invalidity action may be brought to court by any person at any time during the patent term.

filed on the basis of both legal and material grounds. A cassation complaint can be filed on a point of law.

1.25 What are the typical costs of proceedings to first instance judgment on (i) infringement, and (ii) validity? How much of such costs are recoverable from the losing party?

Typical costs for infringement/validity proceedings at first instance vary from €10,000 up to €20,000. Normally, the court grants approximately 50% of the costs claimed (after carefully checking their admissibility to a specific dispute). Costs are recoverable only if the party is represented by an attorney-at-law; fees of patent attorneys are not recoverable.

1.26 For jurisdictions within the European Union: What steps are being taken in your jurisdiction towards ratifying the Agreement on a Unified Patent Court, implementing the Unitary Patent Regulation (EU Regulation No. 1257/2012) and preparing for the unitary patent package? For jurisdictions outside of the European Union: Are there any mutual recognition of judgments arrangements relating to patents, whether formal or informal, that apply in your jurisdiction?

Latvia is prepared to sign the UPC/UPR agreement and it is expected that it will be ratified as soon as it is signed by the UK and Germany.

2 Patent Amendment

2.1 Can a patent be amended ex parte after grant, and if so, how?

Yes. However, the amendments are allowed only if the scope of protection is thereby limited. The amended claims and patent description must be filed with the Patent Office. The Patent Office will publish the amended claims.

2.2 Can a patent be amended in inter partes revocation/invalidity proceedings?

It follows from the law that during the invalidity procedure the court may limit the claims of the patent; this has not yet been confirmed by case law.

2.3 Are there any constraints upon the amendments that may be made?

The amendments must limit the scope of protection.

3 Licensing

3.1 Are there any laws which limit the terms upon which parties may agree a patent licence?

Any licence must comply with the general conditions of the Civil Law on contracts, as well as complying with competition regulations.

Agency TRIA ROBIT Latvia

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7 Antitrust Law and Inequitable Conduct

7.1 Can antitrust law be deployed to prevent relief for patent infringement being granted?

There is no case law on this issue.

7.2 What limitations are put on patent licensing due to antitrust law?

As far as we know, there are no limitations at national level.

8 Current Developments

8.1 What have been the significant developments in relation to patents in the last year?

There were not any significant developments in the last year with regard to patents.

8.2 Are there any significant developments expected in the next year?

It is expected that the UPC agreement will be signed.

8.3 Are there any general practice or enforcement trends that have become apparent in your jurisdiction over the last year or so?

There is a trend of increasing numbers of patent disputes pending in courts.

5.4 Is there a right of appeal from a decision of the Patent Office, and if so, to whom?

Decisions of the Patent Office can be appealed to the Board of Appeal and further to the administrative court of first instance.

5.5 How are disputes over entitlement to priority and ownership of the invention resolved?

Disputes over entitlement to priority and ownership of the invention might be resolved through civil proceedings in court.

5.6 Is there a “grace period” in your jurisdiction, and if so, how long is it?

No, there is no grace period as to prior disclosure of the invention.

5.7 What is the term of a patent?

The term of a patent is 20 years from the filing date.

6 Border Control Measures

6.1 Is there any mechanism for seizing or preventing the importation of infringing products, and if so, how quickly are such measures resolved?

Regulation (EU) No 608/2013 of the European Parliament and of the Council of 12 June 2013 concerning customs enforcement of intellectual property rights is fully applicable. It is possible to file a Customs application for action with regard to a patent and seek the application of a simplified procedure under Article 23 thereof.

Agency TRIA ROBIT Latvia

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Vladimir AnohinAgency TRIA ROBIT5-2 Vilandes str.LV1010 RigaLatvia

Tel: +371 6732 0300Email: [email protected]: www.triarobit.com

Voldemars OsmansAgency TRIA ROBIT5-2 Vilandes str.LV1010 RigaLatvia

Tel: +371 67320 4300Email: [email protected]: www.triarobit.com

Vladimir Anohin is a European and Latvian patent, trademark and design attorney. In 1971 he graduated from the Bonch-Bruyevitch Communications University, St. Petersburg, Russia (Dipl.Eng.). He has extensive experience in advising clients on all aspects of IP protection since 1978. Vladimir has worked in a number of IP departments in various companies. He became a lecturer in 1983 and received an award for his educational work from the head of the USSR Patent Office. After the collapse of the Soviet Union, Vladimir Anohin founded Agency TRIA ROBIT in 1991, which became the leading firm in the region.

Agency TRIA ROBIT is one of the leading intellectual property law firms in Latvia. We offer our clients a full range of intellectual property services covering patents, trademarks, designs, copyright and domain names in the countries of Central and Eastern Europe, Central Asia, Russia and the European Union. The firm also provides advice and assistance on IP protection, management and enforcement worldwide. We offer superior services tailored to specific requirements and budgets of our clients. The firm acts for many IP agencies and law firms based overseas, to assist in the protection of their clients’ intellectual property rights in the area.

Voldemars Osmans graduated from Riga University of Technology in 1980 with a diploma in radio engineering. He has worked in the field of intellectual property since 1993. Voldemars has been a qualified Latvian Patent, Trademark and Design Attorney since 2001 and European Patent, Trademark and Design Attorney since 2005. He is a member of the Latvian Association of Patent Attorneys and INTA. He specialises in the field of inventions, trademarks and industrial designs.

Agency TRIA ROBIT Latvia

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Chapter 17

OLIVARES

Mexico

the presentation of such evidence before commencing proceedings and, where applicable, this authority should ensure the conditions for the protection of confidential information.

1.4 What are the steps each party must take pre-trial? Is any technical evidence produced, and if so, how?

All pieces of evidence should be filed or announced with the original infringement claim or with the invalidity action before the IMPI. The applicable regulations do not contemplate a pre-trial stage, therefore there is no evidence produced in such a stage, but its preparation may be necessary.

1.5 How are arguments and evidence presented at the trial? Can a party change its pleaded arguments before and/or at trial?

Arguments should be filed in writing and following applicable procedural rules. All arguments and evidence must be filed along with the initial brief requesting the infringement action, with an exception being provided for supervening evidence. The general rule is no, parties cannot change their pleaded arguments, unless there are supervening or unknown facts.

1.6 How long does the trial generally last and how long is it before a judgment is made available?

The initial stage before the IMPI of a patent infringement action usually takes two years. Once the IMPI issues a decision, two further stages of appeals before the Courts, lasting no less than three further years, are expected.

1.7 Are judgments made available to the public? If not as a matter of course, can third parties request copies of the judgment?

The IMPI does not make the judgments of patent infringement trials or any proceeding available to the public until they are final and beyond shadow of appeal, and some information regarding the decision remains confidential especially if the parties request it.

1.8 Are there specialist judges or hearing officers, and if so, do they have a technical background?

The IMPI is considered the only authority to solve patent enforcement proceedings in the first instance.

1 Patent Enforcement

1.1 Before what tribunals can a patent be enforced against an infringer? Is there a choice between tribunals and what would influence a claimant’s choice?

In Mexico, the problem of selecting the competent judge or choosing jurisdiction is minimal. Indeed, the only venue to enforce a patent is through administrative proceedings (infringement action) before the Mexican Patent Office (IMPI), which is not a Court of Law, but a Federal administrative entity. IP enforcement is federal law, no state law is available. However, the decisions of this agency on patent infringement cases can be appealed by any one of the intervening parties, thus bringing the matter up before a single specialised IP Court. The decision issued by the specialised IP Court could be appealed before 20 Federal Circuit Courts at Mexico City, however the case is turned randomly by a computer system. By territorial jurisdiction, IP matters are mainly decided at Mexico City.

1.2 What has to be done to commence proceedings, what court fees have to be paid and how long does it generally take for proceedings to reach trial from commencement?

Traditionally, Mexican Courts do not address the existence of patent infringement as, in accordance with the LIP, such cases must be filed and prosecuted with the IMPI. Arguments should be filed in writing and following applicable procedural rules to commence the procedure. Government fees to commence a proceeding (patent infringement or invalidity) before the IMPI are around US$73.The proceeding before the IMPI usually lasts two years. This is the first stage; at least two additional stages are available.

1.3 Can a party be compelled to disclose relevant documents or materials to its adversary either before or after commencing proceedings, and if so, how?

The IMPI may obtain all the evidence deemed as necessary for the verification of facts that may constitute a violation of one or more of the rights protected by this Act or the administrative declaration procedures.When the owner concerned or the alleged infringer has submitted sufficient evidence to reasonably have access to support its claims and has specified evidence relevant to the substantiation of its claims that is under the control of the opposing party, the IMPI may order

Alejandro Luna Fandiño

Sergio Luis Olivares Lobato

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is recognised under the current IP Law. Infringement under the doctrine of equivalence is not expressly provided in the law; a broader interpretation of the patent law to explore the doctrine of equivalents.Nevertheless, recently a Circuit Court in Mexico ruled on behalf of a pharmaceutical company, considering the peripheral interpretation method as a precedent, since it is not mandatory. The Circuit Court considered that, according to the Mexican rules and regulations, the intention of the legislator to grant the claim a fundamental role in the definition of the subject matter of the patent is very clear, since this rule allows the State to protect the industrial property to a greater extent and to prevent actions affecting such exclusivity or that constitute unfair competition and, if applicable, eradicate this practice by means of the imposition of the corresponding sanctions. Therefore, the level of a possible infringing action shall be decreed based on identification with the scope of protection of the claims that shall determine the existence of an eventual infringement due to identity or equivalence.Although this ruling does not exactly implement the U.S. doctrine of equivalence, this is a positive start.

1.14 Can a defence of patent invalidity be raised, and if so, how? Are there restrictions on such a defence e.g. where there is a pending opposition?

According to the IP Law, a defendant can file an invalidity action against a patent as a counterclaim within the same statutory term to file the response to the infringement action. An independent invalidity action can be filed, but if it is not filed along with the brief of response, it may be decided separately from the infringement.

1.15 Other than lack of novelty and inventive step, what are the grounds for invalidity of a patent?

According to the IP Law, patents are valid unless proven otherwise. Thus the IP Law establishes several grounds upon which a patent can be invalidated:(1) When it was granted in contravention of the provisions

on requirements and conditions for the grant of patents or registrations of utility models and industrial designs.

(2) When it was granted in contravention of the provisions of the law in force at the time when the patent or registration was granted. The nullity action based on this section may not be based on a challenge of the legal representation of the applicant when prosecuting and obtaining a patent or a registration.

(3) When the application is abandoned during its prosecution.(4) When granted by error or serious oversight, or when it is

granted to someone not entitled to obtain it. The nullity action mentioned under (1) and (2) may be filed at any time; the actions under (3) and (4) must be filed within five years, counted from the date on which the publication of the patent or registration in the Gazette becomes effective.

1.16 Are infringement proceedings stayed pending resolution of validity in another court or the Patent Office?

Under certain applicable procedural rules, yes; however, the general rule is to decide linked cases’ invalidity and infringement simultaneously.

In January 2009, a specialised IP Division at the Federal Administrative Courts began operating. This Division has jurisdiction to review all cases based on the IPL, the Federal Copyright Act, the Federal Law of Plant Varieties and other IP-related provisions. The creation of this Division should help improve, in general terms, the applicable criteria for IP cases, but the three Magistrates forming this tribunal have no technical background. The last appeal stage is formed by Federal Circuit Magistrates; although they are highly capable in legal issues, they do not need to have IP or technical backgrounds.

1.9 What interest must a party have to bring (i) infringement, (ii) revocation, and (iii) declaratory proceedings?

(1) Any patentee or licensee (unless expressly forbidden from doing so) has the right to prosecute a suit against a third party infringing his or her rights. A distributor may not bring a suit for infringement.

(2) An accused infringer may counterclaim patent invalidity under formal or technical considerations, upon receiving the infringement suit before the IMPI, but it is not possible to request an additional judicial ruling or declaration.

(3) Cease and desist letters provide the required legal standing to initiate invalidity actions. If pertaining to a specific industrial or commercial activity (i.e. the pharma industry), to provide legal standing, this is subject to debate and the Courts are divided.

(4) Amendments to the patent law allow anyone to request the IMPI to initiate officially the cancellation proceeding against patents.

(5) Simple legal standing, namely the mere business or commercial activity to challenge the validity of a patent, is under test before the Courts.

1.10 If declarations are available, can they address (i) non-infringement, and/or (ii) claim coverage over a technical standard or hypothetical activity?

In Mexico, non-infringement declarations are available.

1.11 Can a party be liable for infringement as a secondary (as opposed to primary) infringer? Can a party infringe by supplying part of, but not all of, the infringing product or process?

There is no specific provision in the IP Law relating to the doctrine of contributory infringement, but there is some room to argue in favour of this doctrine; however, it has not been tested before the IMPI or the Courts. Actions may be brought against distributors of an infringing product, and provisional measures may be imposed on third parties to some extent.

1.12 Can a party be liable for infringement of a process patent by importing the product when the process is carried on outside the jurisdiction?

Yes, the infringement of a patent in Mexico includes the commercialisation and importation of a product derived from a patented process even if it is carried on outside Mexico.

1.13 Does the scope of protection of a patent claim extend to non-literal equivalents?

For many years, it has been interpreted that only literal infringement

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The IP Law establishes that the award to the plaintiff in infringement cases cannot be less than 40% of the sale price to the public of each infringing product or service. However, to be allowed to claim damages, the affected title holder must have a final decision declaring the violation of the IP right.

1.20 How are orders of the court enforced (whether they be for an injunction, an award of damages or for any other relief)?

In the event of a second or subsequent offence, the fines previously imposed on the offender shall be doubled. A second or subsequent offence refers to every subsequent infringement of one and the same provision, committed within the two years following the date on which the ruling on the infringement was handed down.Likewise, closures may be ordered in the decision that rules on the infringement, in addition to a fine or without a fine having been imposed. There shall be grounds for permanent closure when the establishment has been temporarily closed twice within a period of two years if, during said period, the infringement is repeated regardless of whether the location thereof has changed.Criminal actions for patent infringement are available for re-offence cases. In accordance with the provisions of our IP Law, re-offence is found when a party infringes a patent after a final and beyond-shadow-of-appeal decision from the IMPI declaring the infringement. This re-offence is considered a felony that can be pursued ex officio or ex parte through the Federal District Attorney Office (PGR). This felony can be punished with up to six years of imprisonment and a fine.

1.21 What other form of relief can be obtained for patent infringement? Would the tribunal consider granting cross-border relief?

Other forms of relief are orders to stop the infringement activity, fines and closure of the facilities where the infringement activities take place. Costs and attorneys’ fees can be recovered in a civil claim for damages and lost profits. This takes place after the IMPI has declared the administrative infringement. The civil Courts follow a specific scheme for reasonable attorneys’ fees, regardless of whether this table reflects the actual fees charged.Criminal sanctions in the event of recidivism are also contemplated in the IP Law.

1.22 How common is settlement of infringement proceedings prior to trial?

Is very unusual to settle cases before the decision is reached, because there are very few incentives for both parties to settle; that is because contingency derived from the infringement proceedings requires a final decision and this would be a long period of time, therefore neither plaintiff nor defendant would face the corresponding recovery/contingency of damages as an actual or imminent situation.

1.23 After what period is a claim for patent infringement time-barred?

The IMPI’s current criterion is that the time limit for seeking a remedy is during the life term of the patent. Once the patent has expired, an action may not be brought for events that took place before the end of the life term (we consider that the IMPI is wrong in this consideration and it is under appeal). A defence of laches

1.17 What other grounds of defence can be raised in addition to non-infringement or invalidity?

The basis of this defence is that the proper interpretation of the patent claim does not catch the alleged infringing product or process.Challenging the validity of patentsUnder the IP Law, patents are valid until the contrary is proven.One of the most common defences in patent litigation in Mexico is to attack the validity of the allegedly infringed patent. As the patent exists, an administrative resolution is required to declare its annulment. This defence must be alleged when replying to the plaintiff’s claim, by means of a counterclaim. The IMPI will give notification of the counterclaim to the party who filed the original complaint. Both the infringement claim and the counterclaim should be resolved simultaneously to preclude the possibility of contradictory outcomes. The grounds for invalidating a patent are mentioned in question 1.15.Fair or experimental useThis refers to the no-profit use of the patented invention.Roche Bolar Exception In the case of medicines, a party shall be entitled to apply for the registration of a product relating to a substance or active ingredient covered by a patent pertaining to someone else, if the application is filed within three years before the corresponding patent expires. This provision, supported by the “Roche Bolar Exception”, would allow the applicant to start performing tests and experiments, in order to be ready to enter the market as soon as the patent has expired.

1.18 Are (i) preliminary, and (ii) final injunctions available, and if so, on what basis in each case? Is there a requirement for a bond?

The Mexican Patent and Trademark Law provides so-called provisional injunctions whereby the IMPI can take certain important measures against infringers. The requirements to get the injunctions are:(1) Proof of a valid right.(2) Presumption of the violation of the patent.(3) Postage of a bond to guarantee damages. If the plaintiff chooses to ask the IMPI for a provisional injunction, a bond will be fixed to warrant possible damages to the defendant. This injunction is to be petitioned in writing and, within a term of 20 days from its execution, the plaintiff is required to file a formal written claim infringement. Failure to do so will cause the plaintiff to lose the bond in favour of the defendant. This party has the right to place a counter-bond to have the effects of the provisional injunction stopped. The defendant has the right to allege whatever he may deem pertinent with respect to the provisional injunctions within a term of 10 days from the day of the execution.

1.19 On what basis are damages or an account of profits assessed?

The IP Law contemplates a claim for damages and lost profit, in a civil law action. Damages and lost profit start accruing from the date on which the existence of an infringement can be proven. Even though claims for damages involve a lengthy proceeding in addition to the administrative infringement action, the wording of Mexican laws intends to provide fair compensation to the affected party.

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errors that are being corrected or the limitations being introduced to the claims.

2.2 Can a patent be amended in inter partes revocation/invalidity proceedings?

In an invalidity action requested by a third party, which may result in a partial nullity of the patent, limiting the scope of the patent, a voluntary amendment would be allowed in an inter partes proceeding if both parties agree and if the general rules of the civil law should be followed; although due to the silence of the law, the IMPI has some difficulty in resolving petitions of limitations during litigation. We have designed a case-by-case basis strategy to overcome this situation.

2.3 Are there any constraints upon the amendments that may be made?

The amendments are restricted to correcting any obvious or form errors, and to limiting the scope of claims, on a case-by-case basis; it is generally advisable to review how the patent to be limited was enforced.

3 Licensing

3.1 Are there any laws which limit the terms upon which parties may agree a patent licence?

It is possible to record a licence either onto a granted patent or in a pending application, so that the same may be opposed against third parties.The limitation to the terms upon which parties may agree a patent licence are found in Article 66, which establishes that the term of the licence may not exceed the natural term of the patent itself and may not be recorded when a patent has already elapsed.Article 67 establishes the chance for the owner to grant further licences unless expressly agreed to the contrary.It is important to mention that the law indicates that the licensee may exert defensive rights over the patent, unless specifically accorded, while working by licensee inures to the benefit of the licensor.Finally, in regard to the cancellation of the licence recordal, the Industrial Property Law establishes that the cancellation occurs when: (1) the same should be requested by both the licensee and the

licensor jointly; (2) the patent lapses or is declared null; or(3) by a Court order.

3.2 Can a patent be the subject of a compulsory licence, and if so, how are the terms settled and how common is this type of licence?

The law states that after three years starting from the date of grant of the patent, or four years from the filing date, whichever is later, anyone may request from the IMPI the grant of a compulsory licence when it has not been used, except if it duly justifies an exit.The same Article also establishes that there will be no grant of a compulsory license when the holder of the patent or a licensee has been carrying the importation of the patented product or the product obtained by the patented process. Further, Article 69 states that the working of a patent by a licensee will be deemed to be worked by

has not been tested before the Courts; therefore, legally speaking, a specific time limit exists in the IP Law to bring an infringement action during the life term of the patent.However, there is a two-year limitation period to pursue a civil action for damages; therefore this statutory term to claim damages should be taken into consideration when looking at the timing to file infringing actions.

1.24 Is there a right of appeal from a first instance judgment, and if so, is it a right to contest all aspects of the judgment?

Appeals against the IMPI can be brought either before the specialised IP Division of the Federal Administrative Court, or before the IMPI itself through a review recourse. Decisions by either Court can be appealed in a final stage before Federal Circuit Courts.

1.25 What are the typical costs of proceedings to first instance judgment on (i) infringement, and (ii) validity? How much of such costs are recoverable from the losing party?

Government fees are minimal in the administration of patent infringements and there are no government costs in the subsequent appeal stages.Costs and attorneys’ fees may be recovered in a civil claim for damages and lost profits.

1.26 For jurisdictions within the European Union: What steps are being taken in your jurisdiction towards ratifying the Agreement on a Unified Patent Court, implementing the Unitary Patent Regulation (EU Regulation No. 1257/2012) and preparing for the unitary patent package? For jurisdictions outside of the European Union: Are there any mutual recognition of judgments arrangements relating to patents, whether formal or informal, that apply in your jurisdiction?

Needless to say, Mexico is not part of the European Union but, as a clarification, there is no binding mandatory provision in the Mexican legal system that would oblige the IMPI and the Mexican Courts to recognise foreign judgments related to patents; this applies for infringement and validity rulings abroad. However, those decisions in jurisdiction abroad would be evaluated and can be persuasive as documentary evidence.In some cases, if the factual pattern and evidence are very similar to the case under review in Mexico, the case ruled in another jurisdiction may have relevant weight when the case is decided in Mexico.

2 Patent Amendment

2.1 Can a patent be amended ex parte after grant, and if so, how?

According to Article 61 of the Industrial Property Law, the text or drawings of a granted patent may only be amended by the patent owner in the following circumstances: (1) to correct any obvious or form errors; and (2) to limit the scope of the claims. The authorised changes shall be published in the Official Gazette.An amendment after allowance is requested in writing to the Mexican Patent Office, briefly explaining the reasons underlying the

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(6) aesthetic creations and artistic or literary works; (7) methods of surgical, therapeutic or diagnostic treatment

applicable to the human body and to animals; and (8) juxtaposition of known inventions or mixtures of known

products, or alteration of the use, form, dimensions or materials thereof, except where in reality they are so combined or merged that they cannot function separately or where their particular qualities or functions have been so modified as to produce an industrial result or use not obvious to a person skilled in the art.

5.2 Is there a duty to the Patent Office to disclose prejudicial prior disclosures or documents? If so, what are the consequences of failure to comply with the duty?

There is no duty for the IMPI to disclose prejudicial prior art or documents.

5.3 May the grant of a patent by the Patent Office be opposed by a third party, and if so, when can this be done?

In a period of six months after the publication of the patent application, information related to patentability of an invention can be filed before the IMPI by a third party. It is worth mentioning that there is a project to amend the Patent Law to reduce the six-month period to two months, in order to speed up the procedure. If filed, the information may be considered at the Examiner’s discretion and it will not suspend the application process. The person filing the information will not be considered a party and will not have access to the patent file or immediate legal standing to challenge a granted patent. After a patent is granted, anyone can inform the IMPI of causes of invalidity. The authority may consider such information discretionally to initiate an ex officio cancellation proceeding.

5.4 Is there a right of appeal from a decision of the Patent Office, and if so, to whom?

Appeals against decisions of the IMPI can be brought either before a specialised IP Division of the Federal Court for Tax and Administrative Affairs, or before Federal District Judges. Decisions by either Court can be appealed in a final stage before Federal Circuit Courts.

5.5 How are disputes over entitlement to priority and ownership of the invention resolved?

Disputes over entitlement to priority and ownership of the invention are resolved by the IMPI. A final decision issued by the IMPI may be appealed (see question 5.4).

5.6 Is there a “grace period” in your jurisdiction, and if so, how long is it?

The Industrial Property Law contemplates a one-year grace period, as follows: “Article 18. The disclosure of an invention shall not prevent

it from continuing to be considered new where, within the 12 months prior to the filing date of the patent application or, where applicable, the recognized priority date, the inventor or his assignee has made the invention known by

its holder, provided that the licence was recorded with the IMPI. Article 71 states that the party applying for a compulsory licence shall have the technical and economical capacity to efficiently work the patented invention. On the other hand, Article 72 establishes that before the grant of the first compulsory licence, the IMPI will provide the patentee with the opportunity to begin working the patent within a term of one year from the date of personal notification given to him. Following a hearing with the parties, the IMPI will decide on the grant of a compulsory licence, and if the IMPI decides to grant it, it will set forth its duration, conditions, field of application and amount of royalties that correspond to the holder of the patent.We are not aware that any compulsory licence has been granted in recent years. In any event, the royalties are established by the IMPI after a hearing with the parties and they should be fair and reasonable.

4 Patent Term Extension

4.1 Can the term of a patent be extended, and if so, (i) on what grounds, and (ii) for how long?

The Mexican Regulations do not establish the possibility of patent life term extensions. However, it is important to mention that the North American Free Trade Agreement (NAFTA) establishes the possibility, but not an obligation, of patent life term extensions when the Health Authority delays the process to obtain a marketing authorisation for a patented product. But Mexico has not adopted the patent life term extensions in its domestic law. The IMPI does not allow an extension on patent terms, as said term extensions are not provided in the Patent Law per se; please be advised that our law firm has achieved corrections gaining more time in the expiration date of patents through legal proceedings only for pipeline patents, granted in accordance with Transitory Article 12 of the Mexican Law for the Promotion and Protection of Industrial Property enacted back in June 1991.

5 Patent Prosecution and Opposition

5.1 Are all types of subject matter patentable, and if not, what types are excluded?

The following subject matter is not patentable in Mexico: (1) essentially biological processes for obtaining, reproducing

and propagating plants and animals; (2) biological and genetic material as found in nature; (3) animal breeds; (4) the human body and the living matter constituting it; and (5) plant varieties. On the other hand, the following subject matter is not considered as invention in Mexico:(1) theoretical or scientific principles; (2) discoveries that consist of making known or revealing

something that already existed in nature, even though it was previously unknown to man;

(3) diagrams, plans, rules and methods for carrying out mental processes, playing games or doing business, and mathematical methods;

(4) computer programs; (5) methods of presenting information;

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(3) Signs, labels, tags, paperwork and similar articles that infringe any of the rights protected by the Industrial Property Law.

(4) Implements or instruments intended or used for the manufacture, preparation or production of any alleged-to-infringe relevant industrial property rights. It is important to mention that the alleged infringer is entitled to file a counter-bond to obtain the lifting of the preliminary injunctions.

In regard to the time frame, once the legal requisites are fulfilled, normally preliminary injunctions are adopted and put into practice in a rather fast fashion that may range from two to seven days, depending on the need to implement the same; i.e. seizures at customs, due to the nature of the importation process and the need for a rather quick implementation, may take 48 hours.Permanent injunctions are declared once the administrative infringement proceeding is finally decided.

7 Antitrust Law and Inequitable Conduct

7.1 Can antitrust law be deployed to prevent relief for patent infringement being granted?

There is no precedent in Mexico of antitrust, unfair competition or business-related tort actions brought against patentees for the use of a patent. Courts generally consider that the use of a state-given right cannot constitute a violation in these areas.

7.2 What limitations are put on patent licensing due to antitrust law?

An action could theoretically be brought for activities falling outside the scope of a patent, such as non-competition agreements for products that are not covered by the claims, product-tying within that scope, or unfair competition activities such as advertising that a product is better than an alternative for the sole reason of it having a patent. Actions could also be brought before the Antitrust Commission for other forms of abuse of patent rights, such as clearly unfounded attempts to enforce a patent.On July 20, 2016, the Mexican Antitrust Commission (known by its Spanish acronym, COFECE) announced that it will conduct a study regarding competition concerns over pharmaceutical products with lapsed patents. This is the first time such a study has been undertaken in Mexico.The Commission will first analyse the rationale behind the fact that there are approximately 350 products listed in the National Formulary with sole suppliers, although around 63% of these products have lapsed patents.COFECE emphasised that this analysis should not be considered in any way as a prejudgment of potential misconducts. It pointed out that this assessment aims to provide Mexican Regulatory Agencies with recommendations on how to encourage competition and correct inefficiencies. We consider that the COFECE official communication in this regard contains several flaws and confuses concepts in order to justify the study. For example, the Commission provides data concerning out-of-pocket expenses of the private sector to explain its reasoning for reviewing public acquisitions of medical products; however, these are separate realms governed by various factors and rules and are not necessarily related.

any means of communication, by putting it into practice or by displaying it at a national or international exhibition. When the corresponding application is filed, the evidentiary documents shall be included in the manner laid down in the Regulations under this Law.

The publication of an invention contained in a patent application or in a patent granted by a foreign office shall not be regarded as corresponding to any of the situations referred to in this Article.”

In order to benefit from the grace period, it is required to file a declaration stating the date, place and means of disclosure, together with the Mexican patent application.

5.7 What is the term of a patent?

The term of a patent is 20 years from the filing date. No extensions of term are available in Mexico.

6 Border Control Measures

6.1 Is there any mechanism for seizing or preventing the importation of infringing products, and if so, how quickly are such measures resolved?

The Industrial Property Law establishes that there are available injunctions for infringement of patent rights on a provisional and permanent basis in Mexico. The Customs Law establishes the rules for implementing the same with the Mexican Customs.Generally speaking, in order to grant a preliminary injunction, it is necessary to comply with certain requisites, such as that the holder of the industrial property right has applied to the products, packaging or wrapping of the products protected by the patent, the marking indications, or, by some other means, have made it public knowledge that there is a protected industrial property right.Other pertinent requisites can be found in Article 199bis 1, which requires that the requesting party complies with the following as well:(1) Prove that they hold a patent right and any of the following in

addition:(a) The existence of an infringement to his right.(b) That the infringement to his right will be imminent.(c) The existence of the likelihood of irreparable damages

suffered.(d) The existence of justified fear that the evidence will be

destroyed, concealed or altered.(2) Grant sufficient bond in order to warrant the damages which

would be caused to the person against whom the measures are demanded.

(3) Provide the IMPI with the information necessary for the identification of the goods or establishments in which or where the infringement to industrial property rights is occurring.

In regard to the scope of the injunctions, the IMPI may order the alleged infringer or third parties to suspend or discontinue the acts constituting a violation of the provisions of law and the seizure of goods such as:(1) Objects manufactured or used illegally.(2) Objects, wrappers, containers, packaging, paperwork,

advertising material and similar articles that infringe any industrial property right protected by the Industrial Property Law.

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8.2 Are there any significant developments expected in the next year?

■ Proposal of the Mexican Patent Law to broaden the scope of compulsory licences.

■ Proposal to amend the Mexican Patent Law for protection of Industrial Designs in order to harmonise the domestic law with the Hague system for the international registration of industrial designs.

■ It is expected that NAFTA and the Free Trade Agreement between Mexico and the European Union will be soon reviewed or renegotiated.

8.3 Are there any general practice or enforcement trends that have become apparent in your jurisdiction over the last year or so?

■ Patent prosecution highways are becoming more common. ■ Importers of medicines have abused the experimental and

Roche Bolar exceptions; now the Courts or the corresponding administrative authorities should establish their limits.

■ Enforcement of Linkage Regulation on formulation and use patents is a hot topic.

■ IP and human rights is a day-to-day argument before the Mexican Courts.

■ Challenging patents based on patentability requirements, rather than the traditional formal arguments, is more common.

■ The dilemmas around the enforcement of biotechnology patents and regulatory matters.

8 Current Developments

8.1 What have been the significant developments in relation to patents in the last year?

On December 16, 2016, the Regulations to the Intellectual Property Law were amended. The key amendments include:■ The recordation of licences, assignments, mergers, securities,

changes of name or address and new legal representatives in several patents/patent applications and/or trademarks may be filed in one single petition or brief as long as the parties are the same.

■ Licence Agreements and Assignment Agreements must be signed by both parties (Assignor and Assignee / Licensor and Licensee). The filing of agreements signed only by the titleholder will no longer be accepted.

■ The petition of recordation of a licence shall only mention the name, nationality and address of Licensor and Licensee; it is no longer required to mention the term of the agreement, to indicate if the Licensee may take any legal actions to protect the patent, and the goods or services to be licensed in case of trademarks.

■ One original or certified and legalised copy of the document reflecting any update in ownership suffices; that is, it is no longer required to pay government fees for the issuance of a certified copy of the original or certified document filed.

■ The term to reply to any official action issued by the IMPI will be two months as of the next working day after notification.

■ The Power of Attorney shall include the name and signature of two witnesses, and it is no longer required to include their address.

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Alejandro Luna FandiñoOLIVARESPedro Luis Ogazón # 17, Col. San Ángel, C.P.01000, Delegación Álvaro ObregónMexico CityMexico

Tel: +52 55 5322 3080Email: [email protected]: www.olivares.com.mx

Sergio Luis Olivares LobatoOLIVARESPedro Luis Ogazón # 17, Col. San Ángel, C.P.01000, Delegación Álvaro ObregónMexico CityMexico

Tel: +52 55 5322 3080Email: [email protected]: www.olivares.com.mx

OLIVARES began in 1969 as an intellectual property boutique. Today, the IP Practice serves many different industries, receives numerous awards for excellence in legal service, and leads the charge in protecting clients’ valuable IP assets. Whether navigating complex pharmaceutical patent regulations, developing trademark protection strategies, or litigating copyright disputes, OLIVARES gets results.

The award-winning patent attorneys and engineers specialise in the fields of chemistry, biotechnology, pharmacology, mechanics, electronics, computer programs (software), bioinformatics and nanotechnology, among others, and work with some of the world’s largest companies to help secure patent rights in Mexico and across Latin America.

Now, with more than 40 years in business, OLIVARES continues its legacy of excellence in client service and attracts clients from all areas of Mexico in addition to clients from foreign countries needing counsel regarding Mexican laws, regulations and cases.

Alejandro Luna Fandiño has litigation specialisation degrees from the Universidad Panamericana, and a Master’s Degree in Intellectual Property Law at the Franklin Pierce Law Centre in Concorde, New Hampshire, U.S.A.

He has proactively participated in cases against the unconstitutionality and inefficiency of certain amendments to the Federal Law of Administrative Proceedings in Mexico, which have precipitated challenges to the resolutions by the Mexican Institute of Industrial Property.

Mr. Luna is also the sponsor of a proposal to modify the litigation system of industrial property, limiting the Mexican Institute of Industrial Property to an exclusive registration authority, transferring the jurisdiction for litigation to Civil Courts in infringement cases, and to Administrative Courts for cases related to the annulment of trademark registrations or patents.

Mr. Luna is the author of several articles on patents, litigation and regulatory issues that have been published both in Mexico and abroad. Mr. Luna is a distinguished member of several associations and currently is the Vice-President of the Mexican Association for the Protection of Industrial Property. He was named in the 2007 Guide as one of the World’s Leading Patent Law Practitioners. Currently, Mr. Luna is a partner in charge of the Appeals Department and co-chair of the Life Sciences group at OLIVARES, and he is a part-time professor at the National University (UNAM).

Sergio L. Olivares, Jr. joined OLIVARES in 1987, becoming a Partner in 1994 and Chairman of the Management Committee in 2009. He leads the firm with strength and a commitment to transparency, client satisfaction, and personal service. Mr. Olivares’ work at OLIVARES is extensive, and he has vast experience in the prosecution and litigation of intellectual property rights, particularly trademarks, copyrights, patents and unfair competition. He has specialised his practice in all types of intellectual property law, but works closely with the Patent group. Mr. Olivares is highly recommended by leading industry titles and rankings as a leader in IP. He has been influential in ensuring that the firm remains highly innovative as we have added new practice areas and industry groups that offer more complex types of work such as regulatory advice and administrative litigation, in addition to the establishment of the Life Science and IT industry groups. After his graduate work, Mr. Olivares trained with two prominent IP law firms in New York City, Morgan & Finnegan and Kenyon & Kenyon, before joining OLIVARES. This deep understanding of US intellectual property law allows him to offer clients clear comparative analyses of the US and Mexican legal systems and explain complex matters in a way that suits our international clients’ needs.

Education:

■ Franklin Pierce Law Center – Intellectual Property, 1993.

■ Universidad Intercontinental – Juris Doctor, 1991.

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Chapter 18

1 Patent Enforcement

1.1 Before what tribunals can a patent be enforced against an infringer? Is there a choice between tribunals and what would influence a claimant’s choice?

Oslo District Court is the compulsory venue for patent actions in Norway, for both infringement cases and revocation actions. Oslo District Court has a panel of judges with particular experience in patent matters, who will hear all cases brought before the court. However, requests for preliminary injunctions must be initiated in accordance with the general law on civil procedure, meaning that the venue will normally be either the District Court where the alleged infringer has its headquarters or, alternatively, the court at the place of infringement. If an infringement action or revocation action is already pending, the venue for the request for a preliminary injunction will be the court handling the ongoing action.

1.2 What has to be done to commence proceedings, what court fees have to be paid and how long does it generally take for proceedings to reach trial from commencement?

A case is initiated by filing a writ with details of the claim and a statement of grounds. Court fees do not have to be paid in order to commence proceedings if the party has legal representation. Normally, the main hearing will be held 6–12 months after proceedings have been initiated.

1.3 Can a party be compelled to disclose relevant documents or materials to its adversary either before or after commencing proceedings, and if so, how?

According to the Norwegian Civil Procedure Act, there is a possibility in certain circumstances to secure evidence and obtain information from a potential defendant or a third party prior to filing a court action. According to section 28-2, evidence may be secured from a potential defendant or a third party prior to filing a court action if the possible claimant can show that there is either i) a clear risk that the evidence will be lost or considerably impaired, or ii) other reasons why it is particularly important to obtain access to the evidence before a lawsuit is instigated. A decision regarding such evidence may be made ex parte if there is reason to fear that notice to the opposite party could obstruct the securing of evidence. A subsequent oral

hearing can, however, be requested by the opposite party. The petitioner shall not, in that case, be allowed access to the evidence until the ruling is final if it may be important for the opposite party to prevent such access.Further, section 28 A-1 holds that when there are reasonable grounds to believe that there has been a patent infringement, or that a patent infringement may occur, the court may, at the request of the patent holder, order the (potential) infringer to disclose the origin and the distribution network of the infringing (or potential infringing) product. The (potential) infringer shall be given the opportunity to express its views before a decision is taken by the court. Information disclosure with a basis in section 28 A-1 cannot be made ex parte.After proceedings have been initiated, each party may request that the other party produce evidence in the possession of that party. For instance, the patent owner can ask the alleged infringer to submit documents demonstrating the production process used or samples of a product for analysis. However, the rules on such disclosure interact with rules on the protection of confidential business information. Hence, the court can establish regimes under which only a limited number of persons on the opposing side are given access to the documents in order to ensure their confidentiality.

1.4 What are the steps each party must take pre-trial? Is any technical evidence produced, and if so, how?

The pre-trial proceedings consist of: (i) service of the writ on the defendant, who is given a deadline for a defence reply; (ii) service of a defence, which might include a writ in an invalidity action; (iii) a meeting with the judge, normally by teleconference, at which directions for the further conduct of the actions are given, including deadlines for procedural steps such as submission of proposals for expert lay judges, etc.; (iv) scheduling of the trial date and appointment of expert lay judges by the court; (v) exchange of pleadings between the parties where arguments that will be put forward are presented and evidence, such as expert reports on the infringement/validity issues, is submitted; and (vi) two weeks before the trial begins, exchange of short statements of claim where the arguments of the parties are summarised. Generally, all evidence must be submitted at the latest within two weeks of the trial.

1.5 How are arguments and evidence presented at the trial? Can a party change its pleaded arguments before and/or at trial?

After a short introductory speech by the legal judge, the attorney appearing for the claimant is given the floor for the opening, at which point he or she will present the case and the documentary

Lars Erik Steinkjer

Gunnar Meyer

Wikborg Rein

Norway

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NorwayWikborg Rein

1.9 What interest must a party have to bring (i) infringement, (ii) revocation, and (iii) declaratory proceedings?

(i) The claimant must demonstrate a legal interest in the action, normally by being the owner, co-owner or exclusive licensee of the patent.

(ii) As long as a patent is in force, any party may initiate an action to have the patent revoked.

(iii) The claimant must, in declaratory proceedings, demonstrate an actual need to have the claim decided against the defendant. Normally, this is done by referring to the claimant’s plan to launch a product which the patentee is likely to allege infringes the patent. The likelihood of the patent owner alleging infringement may be demonstrated by referring either to warning letters from the patent owner or to the claimant having requested an acknowledgment that the launch would not be regarded as patent infringement, without the patent owner having been willing to provide such acknowledgment.

1.10 If declarations are available, can they address (i) non-infringement, and/or (ii) claim coverage over a technical standard or hypothetical activity?

As stated in question 1.8 above, declaratory proceedings are only available if the claimant can demonstrate an actual need to have the claim decided against the defendant. Thus, a claim for a declaratory judgment can address non-infringement or claim coverage over a technical standard if the claimant can demonstrate that he or she has actual plans to commercially exploit a sufficiently defined product or process. On the other hand, purely hypothetical activities by the claimant will not be sufficient.

1.11 Can a party be liable for infringement as a secondary (as opposed to primary) infringer? Can a party infringe by supplying part of, but not all of, the infringing product or process?

Yes. A person infringes a patent where he supplies or offers to supply a person in Norway other than the licensee with any essential element of an invention when he knows, or it would be obvious from the circumstances, that this was suitable and intended for putting the invention into effect in Norway. However, the supply of a “staple commercial product” is not an infringement unless it is made for the purposes of inducing infringement. Knowledge of the patent is not a prerequisite for infringement; knowledge of the intended product or process is sufficient. A person may also be found liable for secondary infringement by other forms of inducement or contribution to infringing acts.

1.12 Can a party be liable for infringement of a process patent by importing the product when the process is carried on outside the jurisdiction?

Yes. A party can be liable for infringement of a process patent by importing a product made by a process protected by the patent.

1.13 Does the scope of protection of a patent claim extend to non-literal equivalents?

Yes; in 2009, the Norwegian Supreme Court confirmed that the protection of a patent extends to equivalents, but with a rather narrow scope. According to the Supreme Court, protection

evidence, including reading aloud those sections of the documentary evidence that the claimant wishes the court to rely on. Thereafter, the defendant’s attorney will take the floor for the opening of the defence. In principle, that statement should be shorter than the claimant’s, only supplementing the arguments and evidence presented by the claimant; but in patent cases, it is normally accepted that the defendant’s statement is as long and thorough as the claimant’s statement.After the opening speeches, witness examination follows, with the claimant’s witnesses and experts first. The claimant’s witnesses are first examined by the claimant’s attorney, and then cross-examined by the defendant’s attorney before answering questions from the panel of judges. The claimant’s attorney can, if necessary, ask for the floor again for follow-up questions. The same procedure is followed for the defendant’s witnesses. For expert witnesses, the witness statement will encompass presentation of the issues discussed in the written report.Upon closing of the evidence, the claimant, and afterwards the defendant, is given the floor again for closing statements, in which the relevant law is discussed and the case argued in the light of the law and the evidence presented at trial. The judges may ask questions at any stage during the proceedings, and often do so.New arguments can only be introduced/changed before the main hearing, normally up until two weeks before the hearing.

1.6 How long does the trial generally last and how long is it before a judgment is made available?

A trial will generally take from four to five days for an infringement or invalidity action, and between 12 and 15 days in complex cases concerning both infringement and validity. A written judgment should be handed down within four weeks, but it often takes longer, depending on the workload of the individual judge and the complexity of the case. In complex cases, judgment may take eight weeks or even longer.

1.7 Are judgments made available to the public? If not as a matter of course, can third parties request copies of the judgment?

Yes, judgments are normally made available to the public via subscription databases. The courts will also make copies of judgments available upon request from third parties. If confidential information is referred to in a judgment, upon request the information can be redacted.

1.8 Are there specialist judges or hearing officers, and if so, do they have a technical background?

Yes; in ordinary patent cases, there will be two appointed expert lay judges in both the first and second instance – in the first instance along with one legal judge, while in the second instance, there will be three legal judges accompanying them. The expert lay judges are normally appointed upon proposal (often joint) from the parties, and have their background within the technical field to which the case relates. They will not be contacted by the parties in advance of being appointed, and will normally not be informed of which party has proposed them.Expert lay judges cannot be appointed in preliminary injunction proceedings, but in such proceedings it is common to use court-appointed experts. Such experts are not associated with any of the parties, and will be appointed to assist the legal judge in their assessment of the case. They will not be part of the panel of judges, but will hear the trial and deliver an opinion on the matter in open court. Often, they also deliver a written opinion.

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1.18 Are (i) preliminary, and (ii) final injunctions available, and if so, on what basis in each case? Is there a requirement for a bond?

(i) A preliminary injunction is available on the condition that the claimant establishes as probable that there is either an infringement of a patent or that the defendant has made significant preparatory acts with the aim of carrying out an infringing act. Moreover, the claimant must establish that an injunction is necessary, as pursuing the claim would otherwise be substantially more difficult or cause substantial harm or inconvenience. In addition, the court must find that an injunction is justified when taking into account the interests of both parties. Upon granting a preliminary injunction, the court may order the claimant to provide a guarantee for compensation to the defendant in the event that it is later established that the injunction was unjustified.

(ii) Final injunctions are granted if the claimant is successful at proving infringement or significant preparatory acts with the aim of carrying out an infringing act at trial.

1.19 On what basis are damages or an account of profits assessed?

Damages are normally assessed as part of the infringement action, i.e. there is no separate procedure for establishing the quantum of damages. The infringer is liable for damages in the form of remuneration for the exploitation of the invention and, if applicable, compensation for any further economic loss to the claimant caused by the infringement. The patentee can also choose to claim the infringer’s profits. Thus, the patent owner can either claim their own lost profits, reasonable royalties on sales by the defendant, or the defendant’s profits.If the infringement has been committed intentionally or through gross negligence, the patentee can claim compensation corresponding to a double reasonable royalty.

1.20 How are orders of the court enforced (whether they be for an injunction, an award of damages or for any other relief)?

If a party does not comply with an order in form of an injunction, the order may be enforced upon request by an enforcement officer.If a party does not comply with an order in form of an award of damages, the order may be enforced through ordinary procedures for enforcement of monetary awards.

1.21 What other form of relief can be obtained for patent infringement? Would the tribunal consider granting cross-border relief?

The court may order the measures which the court finds appropriate for preventing further infringements, e.g. recall, destruction or surrender to the patentee of infringing goods. The same applies to materials or means which are mainly used or intended to be used in the production of infringing goods. The court may also order that the infringer shall bear the costs of communicating a judgment to the public.In principle, the Norwegian courts could consider granting cross-border relief, but there are no examples of this in the case law.

1.22 How common is settlement of infringement proceedings prior to trial?

As cases can be settled at any stage of the proceedings, settlements prior to trial are not uncommon in Norway.

by equivalence is a matter of claim construction and can only encompass modifications that are “fairly identical” to the features set out in the patent claim.

1.14 Can a defence of patent invalidity be raised, and if so, how? Are there restrictions on such a defence e.g. where there is a pending opposition?

Yes, but in ordinary proceedings, a court cannot dismiss an infringement claim on the basis that the patent is invalid, unless the defendant has filed a separate claim for invalidity with a statement of grounds. It is not sufficient to raise invalidity as a mere defence to infringement. However, in interim injunction proceedings, the defendant may argue invalidity as a basis for their defence. The court may decide not to grant an injunction on the basis that the patent is most likely invalid.There are no restrictions on such invalidity defences.

1.15 Other than lack of novelty and inventive step, what are the grounds for invalidity of a patent?

The grounds are (i) insufficiency (the lack of enablement or the lack of support for the claims in the description), (ii) extension of the subject matter compared to the application as filed, (iii) extension of the scope of protection by a post-grant amendment to the claims that should not have been allowed, (iv) lack of industrial applicability, (v) the patent was granted to someone not entitled to it, and (vi) the subject matter of the application is not patentable as such.

1.16 Are infringement proceedings stayed pending resolution of validity in another court or the Patent Office?

As the Oslo District Court is the compulsory venue for both infringement cases and revocation actions (as of 1 July 2013), infringement and revocation actions will, in most cases, be joined and heard together. Thus, the infringement proceeding will normally not be stayed. When Norway acceded to the European Patent Convention (EPC) on 1 January 2008, the Patents Act was amended with a provision stating that a court may decide to stay a trial until a final decision concerning the same patent is delivered by the European Patent Office (EPO). In practice, this also applies to Norwegian patents granted nationally, but the court will normally only stay the proceedings if a decision from the EPO can be expected within a few months. The fact that the validity of a corresponding patent is disputed in another country is normally not considered directly relevant for proceedings in Norway.If invalidity or revocation proceedings are pending before both the Norwegian Patent Office and a court at the same time, one of the actions will be stayed, and this will normally be the proceedings before the Patent Office.

1.17 What other grounds of defence can be raised in addition to non-infringement or invalidity?

One other ground of defence is that the defendant is entitled to a compulsory licence. Other available defences include the defendant being entitled to a prior use right on the basis that he was already using the invention before the priority date.

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2 Patent Amendment

2.1 Can a patent be amended ex parte after grant, and if so, how?

Yes, after the opposition period, a patent can be amended upon request by the patent owner. Amendments can be made to the claims or the description. In accordance with Article 105a EPC, the owner of a European patent can also direct a request for an amendment to the EPO.

2.2 Can a patent be amended in inter partes revocation/invalidity proceedings?

Yes, a patent can be amended in administrative proceedings before the Patent Office or in a trial before the court.

2.3 Are there any constraints upon the amendments that may be made?

Yes, the amendments must have support in the specification of the patent and cannot extend the scope of protection. The amended claims must also satisfy the patentability criteria.

3 Licensing

3.1 Are there any laws which limit the terms upon which parties may agree a patent licence?

Yes: the parties cannot agree upon terms prohibited by Norwegian competition law or EEA/EU competition law. Terms that restrict competition on the relevant market and extend the monopoly conferred by the patent, for instance by restricting the licensee’s use of its own technology, might be unlawful under competition law.

3.2 Can a patent be the subject of a compulsory licence, and if so, how are the terms settled and how common is this type of licence?

Yes, compulsory licences can be granted by the court or, since 2004, by the Norwegian Competition Authority. Compulsory licences are available if (i) the invention is not commercially used in Norway within three years, (ii) the applicant is the inventor of another invention which constitutes an important technical contribution of economic significance compared to the invention in question, (iii) significant public interest requires a compulsory licence, or (iv) if patent rights are exercised in a way that significantly restricts competition in the relevant market.The terms of the compulsory licence are set by the court or the competition authorities, but compulsory licences are rarely granted. Since 2004, there has only been one request to the Norwegian Competition Authority for a compulsory licence. However, the request was denied and the decision was upheld by the Ministry of Health and Care Services on appeal.

1.23 After what period is a claim for patent infringement time-barred?

The time period for claiming damages based on a patent infringement is three years from when the cause of action accrued. This period will commence at the time of infringement, but if the infringement has been concealed during this three-year period, the damage claim is not time-barred until the expiration of a one-year period from the time when the claimant should have discovered, with reasonable diligence, the infringement.

1.24 Is there a right of appeal from a first instance judgment, and if so, is it a right to contest all aspects of the judgment?

Yes. The appeal will give rise to a new trial in which the case is heard again in full. New arguments and new evidence are allowed.

1.25 What are the typical costs of proceedings to first instance judgment on (i) infringement, and (ii) validity? How much of such costs are recoverable from the losing party?

Infringement and validity will usually be dealt with together at the same trial. However, if the matter only concerns either infringement or validity, the costs in complex cases with large values at stake (such as pharmaceutical patent matters) will typically be in the region of 1.5m–3m NOK. If the trial concerns both infringement and validity, the costs will typically be in the region of 2m–5m NOK. The complete costs are recoverable from the losing party unless the court decides to reduce the amount as being unreasonably high. Further, the court may decide that the winning party should bear its own costs partially or in full, for instance if the winning party is to blame for the matter coming before a court.

1.26 For jurisdictions within the European Union: What steps are being taken in your jurisdiction towards ratifying the Agreement on a Unified Patent Court, implementing the Unitary Patent Regulation (EU Regulation No. 1257/2012) and preparing for the unitary patent package? For jurisdictions outside of the European Union: Are there any mutual recognition of judgments arrangements relating to patents, whether formal or informal, that apply in your jurisdiction?

Following the European Member States’ implementation of Regulation (EC) No. 44/2001 (the Brussels I Regulation), the EFTA States have adopted similar rules under the Lugano Convention of 2007. The Lugano Convention, which also applies for patent matters and judgments, is a dual convention governing direct jurisdiction of the courts in the States that are bound by the Convention, coordination between courts in the event of competing jurisdiction, conditions for the recognition of judgments, and a simplified procedure for their enforcement. Outside the scope of the Lugano Convention, Norway is party to a few bilateral conventions of regulating recognition and enforcement of judgments (mostly with countries that are also a party to the Lugano Convention).

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5.6 Is there a “grace period” in your jurisdiction, and if so, how long is it?

No, there is not.

5.7 What is the term of a patent?

The term of a patent is 20 years from the filing date.

6 Border Control Measures

6.1 Is there any mechanism for seizing or preventing the importation of infringing products, and if so, how quickly are such measures resolved?

Customs Regulation (EC) No. 1383/2003 does not apply in Norway. However, Norway has implemented quite a similar customs regime, under which the court can issue a preliminary injunction ordering the custom authorities to seize products if importation of the products will constitute infringement of intellectual property rights. An injunction can be issued even if the recipient of the products is unknown. If necessary, a preliminary injunction can be issued without an oral hearing of the evidence.The customs authorities can also, ex officio, decide to withhold goods for up to 10 days if they have reasonable grounds to suspect that the goods will constitute infringement of intellectual property rights. If the goods are withheld, notice shall be given to the recipient of the goods and the patent owner. To prevent further release of the goods, the patent owner must obtain a preliminary injunction.

7 Antitrust Law and Inequitable Conduct

7.1 Can antitrust law be deployed to prevent relief for patent infringement being granted?

No, but upon request, the court or the Norwegian Competition Authority may grant a compulsory licence based on competition law.

7.2 What limitations are put on patent licensing due to antitrust law?

See the answer to question 3.1 above.

8 Current Developments

8.1 What have been the significant developments in relation to patents in the last year?

There have been no significant developments this year.

8.2 Are there any significant developments expected in the next year?

On 22 June 2017, the Ministry of Justice issued a consultation paper with proposals for amendments to the Patent Act. This might result in certain amendments to the Patent Act in 2018 or 2019.

4 Patent Term Extension

4.1 Can the term of a patent be extended, and if so, (i) on what grounds, and (ii) for how long?

The term of a patent cannot be extended, but Supplementary Protection Certificates (SPCs) are available for patents which cover an authorised medicinal or plant pharmaceutical product. By application of the EEA Agreement, the EU law on SPCs is implemented into Norwegian law.

5 Patent Prosecution and Opposition

5.1 Are all types of subject matter patentable, and if not, what types are excluded?

All forms of technical inventions are patentable in accordance with the EPC and the WTO TRIPS Agreement. The Norwegian Patents Act contains the same exclusions of subject matter as the EPC.

5.2 Is there a duty to the Patent Office to disclose prejudicial prior disclosures or documents? If so, what are the consequences of failure to comply with the duty?

No, there is not.

5.3 May the grant of a patent by the Patent Office be opposed by a third party, and if so, when can this be done?

Yes, a third party can oppose the grant of a patent within nine months of the grant. If the patent is opposed based on ordre public or morality, the opposition period is three years.After the expiry of the opposition period, a third party may, during the entire term of the patent, apply for revocation of the patent by administrative proceedings before the Patent Office.

5.4 Is there a right of appeal from a decision of the Patent Office, and if so, to whom?

A decision from any division of the Patent Office may be appealed to the Norwegian Board of Appeal for Industrial Property Rights – a body independent of the Patent Office with members appointed in their individual capacity. A decision from the Board of Appeal for Industrial Property Rights rejecting a patent application or revoking a patent may be brought before Oslo District Court. The basis for the court’s review will be the same as before the Patent Office.

5.5 How are disputes over entitlement to priority and ownership of the invention resolved?

Disputes over entitlement to priority are dealt with during prosecution of the patent application, opposition proceedings or in revocation proceedings. Disputes over ownership may be raised during the prosecution of the patent application or in an opposition proceeding. The Patent Office may invite the alleged proprietor of the patent to initiate court proceedings against the applicant. Court proceedings can also be initiated after the patent has been granted within defined time limits.

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8.3 Are there any general practice or enforcement trends that have become apparent in your jurisdiction over the last year or so?

There has been an increased tendency to assert grounds for invalidity other than lack of novelty and inventive step, such as insufficiency and added matter.

Wikborg Rein is one of Norway’s leading law firms, with close to 230 lawyers in Oslo, Bergen, London, Singapore and Shanghai.

The firm is established as one of the most experienced in Norway in respect of patent litigation. The IP Group of Wikborg Rein is also engaged in other aspects of intellectual property law such as trademarks, copyright and adjacent areas of law, including unfair competition law. Wikborg Rein also provides assistance regarding management and utilisation of intellectual property rights, such as protection of rights and negotiation of licence and technology transfer agreements.

Lars Erik Steinkjer works as Specialist Counsel at Wikborg Rein’s Oslo office and joined the firm in 2010 after completing his Ph.D. in patent law at the University of Bergen. He is regularly involved in patent matters, notably within the offshore, fish farming and pharmaceutical sectors. Steinkjer also works within related areas of intellectual property, such as unfair competition and protection of trade secrets.

Lars Erik SteinkjerWikborg Rein Advokatfirma ASDronning Mauds gate 11P.O. Box 1513 Vika0117 OsloNorway

Tel: +47 2282 7547Email: [email protected]: www.wr.no

Gunnar Meyer heads the patent litigation group in Wikborg Rein. He has pleaded several major patent cases related to pharmaceuticals, offshore drilling, fish farming and other sectors of industry. His main focus is litigation in intellectual property matters, especially within the areas of patent and trademark law. He was admitted to the Bar in 1987 and to the Supreme Court in 1990 and has extensively pleaded cases in complex matters before the courts at all levels, including the Supreme Court.

Gunnar MeyerWikborg Rein Advokatfirma ASDronning Mauds gate 11P.O. Box 1513 Vika0117 OsloNorway

Tel: +47 2282 7624Email: [email protected]: www.wr.no

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Chapter 19

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Philippines

books, accounts, letters, photographs, objects or tangible things, not privileged, which constitute or contain evidence material to any matter involved in the action and which are in his possession, custody or control; or (b) order any party to permit entry upon designated land or other property in his possession or control for the purpose of inspecting, measuring, surveying, or photographing the property or any designated relevant object or operation thereon. The order shall specify the time, place and manner of making the inspection and taking copies and photographs, and may prescribe such terms and conditions as are just.

1.4 What are the steps each party must take pre-trial? Is any technical evidence produced, and if so, how?

Parties are required to file their respective pre-trial briefs with the RTC or the BLA (and serve a copy thereof on the other party) at least three days before the date of pre-trial stated in the Notice of pre-trial. The pre-trial brief must include, among other things, a summary of admitted facts and proposed stipulation of facts, the issues to be resolved, the documents or exhibits to be presented at trial, including a statement of their purpose(s), the number and names of witnesses to be presented at trial, and an abstract or summary of their testimonies. The originals of the documentary evidence must be produced for comparison and marking. An abstract or summary of the witnesses’ testimonies must be stated in the pre-trial brief.

1.5 How are arguments and evidence presented at the trial? Can a party change its pleaded arguments before and/or at trial?

In the RTC, a party presents his evidence at the trial by calling his witness to be examined in open court, and under oath or affirmation. The order in which an individual witness may be examined is as follows: (a) direct examination by the proponent; (b) cross-examination by the opponent; (c) re-direct examination by the proponent; and (d) re-cross-examination by the opponent. The party presenting a witness must make a formal offer of the witness’s testimonial evidence at the time the witness is called to testify. Documentary and object evidence are offered after the presentation of a party’s testimonial evidence. Upon admission of the evidence, the case shall be deemed submitted for decision, unless the RTC directs the parties to argue or to submit their respective memoranda or any further pleadings.The trial procedure followed in the BLA is very similar to that in the RTC.

1 Patent Enforcement

1.1 Before what tribunals can a patent be enforced against an infringer? Is there a choice between tribunals and what would influence a claimant’s choice?

Patents are enforced against an infringer either through a civil action before the Regional Trial Court (“RTC”) or an administrative action before the Bureau of Legal Affairs (“BLA”) of the Intellectual Property Office of the Philippines (“IPOPHL”). The factors that usually influence a claimant’s choice are cost and time considerations.

1.2 What has to be done to commence proceedings, what court fees have to be paid and how long does it generally take for proceedings to reach trial from commencement?

In the RTC, proceedings are commenced by the filing of the complaint, payment of the necessary filing fees and the service of summons on the defendant. Upon receipt of the summons, the respondent may file either a Motion to Dismiss, or an Answer, setting out the defendant’s affirmative and/or negative defences including any counterclaims. The case is then set for a pre-trial conference, where the parties, among others, discuss the possibility of settlement or the referral of the case to alternative models of dispute resolution, proposed stipulation of facts, issues to be resolved, and documents and witnesses to be presented at trial. It may take anywhere from six to 12 months from the filing of the complaint for the case to reach proper trial in court. The pre-trial procedural stages in the BLA are substantially similar to those before the RTC. However, since the proceedings in the BLA are administrative in nature and not strictly governed by technical rules of procedure and evidence, it usually takes five to seven months from the filing of the complaint for the case to reach trial in the BLA.

1.3 Can a party be compelled to disclose relevant documents or materials to its adversary either before or after commencing proceedings, and if so, how?

Upon motion of any party showing good cause therefor, the court in which an action is pending may: (a) order any party to produce and permit the inspection and copying or photographing, by or on behalf of the moving party, of any designated documents, papers,

Vida M. Panganiban-Alindogan

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infringement proceedings may seek a declaration of non-infringement or invalidity of a patent (independently of an infringement suit). There is a procedure for declaratory relief under the Philippine Rules of Court, but this appears to have never been tested or applied with respect to a patent right.

1.10 If declarations are available, can they address (i) non-infringement, and/or (ii) claim coverage over a technical standard or hypothetical activity?

Yes, through the various modes of Discovery provided in the Philippine Rules of Court. These include the taking and use of depositions, interrogatories to parties, requests for admission, production or inspection of documents or things, and physical and mental examination of persons.

1.11 Can a party be liable for infringement as a secondary (as opposed to primary) infringer? Can a party infringe by supplying part of, but not all of, the infringing product or process?

Yes. Under the IP Code, anyone who actively induces the infringement of a patent or provides the infringer with a component of a patented product or of a product produced because of a patented process, knowing it to be especially adopted for infringing the patented invention and not suitable for substantial non-infringing use, shall be liable as a contributory infringer and shall be jointly and severally liable with the infringer.

1.12 Can a party be liable for infringement of a process patent by importing the product when the process is carried on outside the jurisdiction?

Yes. The IP Code states that importing a patented product or a product obtained directly or indirectly from a patented process, or the use of a patented process without the authorisation of the patentee, constitutes patent infringement.

1.13 Does the scope of protection of a patent claim extend to non-literal equivalents?

Yes. The IP Code specifically states that, for the purpose of determining the extent of protection conferred by a patent, due account shall be taken of elements which are equivalent to the elements expressed in the claims, so that a claim shall be considered to cover not only all the elements as expressed therein, but also equivalents.

1.14 Can a defence of patent invalidity be raised, and if so, how? Are there restrictions on such a defence e.g. where there is a pending opposition?

Yes. In an action for infringement, the defendant, in addition to other defences available to him, may show the invalidity of the patent, or any claim thereof, on any of the grounds on which a petition of cancellation can be brought under Section 61 of the IP Code.

1.15 Other than lack of novelty and inventive step, what are the grounds for invalidity of a patent?

The other grounds for invalidity are: (i) the patent does not cover a patentable subject matter; (ii) the patent does not disclose the invention in a manner sufficiently clear and complete for it to be

A party may amend his pleading once as a matter of right at any time before a responsive pleading is served. Substantial amendments may be made only upon leave of court. But such leave may be refused if it appears to the court that the motion was made with intent to delay. When issues not raised by the pleadings are tried with the express or implied consent of the parties, they shall be treated in all respects as if they had been raised in the pleadings. Such amendment of the pleadings as may be necessary to cause them to conform to the evidence and to raise these issues may be made upon motion of any party at any time, even after judgment; but failure to amend does not affect the result of the trial of these issues. If evidence is objected to at the trial on the grounds that it is not within the issues made by the pleadings, the court may allow the pleadings to be amended and shall do so with liberality if the presentation of the merits of the action and the ends of substantial justice will be sub-served thereby.

1.6 How long does the trial generally last and how long is it before a judgment is made available?

The length of the proceedings depends on a variety of factors, including the complexity of the legal and technical issues involved, the number of witnesses to be presented, the number of postponements of trial sought by the parties, as well as the caseload of the RTC and/or BLA handling the case. It may take as long as three to five years (from filing of the complaint) before a decision is issued by the RTC. Administrative proceedings in the BLA usually take around one to three years from the filing of the complaint for a case to be resolved on the merits.

1.7 Are judgments made available to the public? If not as a matter of course, can third parties request copies of the judgment?

Yes. The records of every court are considered public records and shall be available for the inspection of any interested person, at all proper business hours, under the supervision of the clerk having custody of such records, unless the court, in any special case, has forbidden their publicity, in the interest of morality or decency.

1.8 Are there specialist judges or hearing officers, and if so, do they have a technical background?

There are RTCs designated as Special Commercial Courts which try and decide commercial cases, including cases involving violations of intellectual property rights. Judges in these Special Commercial Courts do not always have technical backgrounds. However, the court may appoint two or more assessors, possessing the necessary scientific and technical knowledge to assist the court during trial. Most Hearing Officers in the BLA likewise do not have a technical background.

1.9 What interest must a party have to bring (i) infringement, (ii) revocation, and (iii) declaratory proceedings?

(i) The plaintiff in an infringement case must be a patentee, or anyone possessing any right, title, or interest in and to the patented invention, whose rights have been infringed.

(ii) The petitioner in a cancellation proceeding may be any interested person.

(iii) The IP Code and regulations currently do not provide for procedures where a person aggrieved of threats of

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suspension, modification or restoration of the injunction. The stay of execution shall be upon such terms as to bond or otherwise as may be considered proper for the security or protection of the rights of the adverse party. On the other hand, judgments by the BLA (including those granting a permanent injunction) may, upon motion of the prevailing party with notice to the adverse party or motu proprio, and upon filing of an approved bond, be executed even before the expiration of the time to appeal has lapsed, upon good reasons to be stated in the BLA Order. The execution pending appeal may be stayed by the filing of an approved counterbond in an amount to be fixed by the BLA Director.

1.19 On what basis are damages or an account of profits assessed?

The IP Code provides that the patentee is entitled to actual damages, plus attorneys’ fees and other expenses of litigation. If the damages are inadequate or cannot be readily ascertained with reasonable certainty, the court may award by way of damages a sum equivalent to reasonable royalty. The court may, according to the circumstances of the case, award damages in a sum above the amount found as actual damages sustained, provided it does not exceed three times the amount of such actual damages.

1.20 How are orders of the court enforced (whether they be for an injunction, an award of damages or for any other relief)?

Execution shall issue as a matter of right, or motion, upon a judgment or order that disposes of the action or proceeding upon the expiration of the period to appeal therefrom if no appeal has been duly perfected. If a judgment directs a party to, among others, execute a conveyance of land or personal property, or to deliver deeds or other documents, or to perform any other specific act in connection therewith, and the party fails to comply within the time specified, the court may direct the act to be done at the cost of the disobedient party by some other person appointed by the court and the act, when so done, shall have like effect as if done by the party. If real or personal property is situated within the Philippines, the court, in lieu of directing a conveyance thereof, may by an order divest the title of any party and vest it in others, which shall have the force and effect of a conveyance executed in due form of law.

1.21 What other form of relief can be obtained for patent infringement? Would the tribunal consider granting cross-border relief?

In addition to damages and injunction, the prevailing plaintiff may also recover from the infringer attorneys’ fees and other expenses of litigation. The RTC may also order that the infringing goods, materials and implements predominantly used in the infringement be disposed of outside the channels of commerce or destroyed, without compensation.The following administrative remedies are available before the BLA: (1) issuance of a cease-and-desist order; (2) acceptance of a voluntary assurance of compliance or discontinuance as may be imposed; (3) condemnation or seizure of products which are the subject of the offence; (4) forfeiture of paraphernalia and all real and personal properties which have been used in the commission of the offence; (5) imposition of administrative fines; (6) cancellation (or suspension of the validity) of any permit, licence, authority, or registration which may have been granted by the IPOPHL; (7) withholding of any permit, licence, authority, or registration being

carried out by any person skilled in the art; (iii) that the patent is contrary to public order or morality; (iv) the patent includes matters outside the scope of the disclosure contained in the application as filed; or (v) the patent was issued to a person not entitled to the same, and the person declared by final court order as having the right to the patent seeks the cancellation of the patent.

1.16 Are infringement proceedings stayed pending resolution of validity in another court or the Patent Office?

Unlike for trademarks, where Sec. 151.2 of the IP Code expressly provides that the pendency of a petition to cancel a mark before the IPOPHL will not constitute a prejudicial question that must be resolved before an action to enforce the rights to the same registered mark may be decided, there is no such similar provision for patents. This notwithstanding, there is basis to argue that Sec. 151.2 can be applied analogously to patents.

1.17 What other grounds of defence can be raised in addition to non-infringement or invalidity?

Other legal defences include: (i) prescription of the action; and (ii) the defendant having an existing licence. In cases where the infringement case is filed to obtain damages for infringing acts committed by the defendant after the publication of the application in the IPOPHL E-Gazette but before grant of the patent, a possible legal defence would be that the respondent had no actual knowledge, nor received written notice that the invention he was using was the subject matter of a published application.

1.18 Are (i) preliminary, and (ii) final injunctions available, and if so, on what basis in each case? Is there a requirement for a bond?

Yes.(i) A preliminary injunction may be granted by an RTC at

any time after the commencement of the action and before judgment, when it is established that: (a) the plaintiff is entitled to the relief demanded, and the whole or part of such relief consists in restraining the commission or continuance of the acts complained of, or in the performance of an act or acts, either for a limited period or perpetually; (b) the commission or continuance of some act complained of during the litigation or the non-performance thereof would probably work injustice to the plaintiff; or (c) the defendant is doing, threatens, or is about to do, or is procuring or suffering to be done, some act probably in violation of the plaintiff’s rights in respect of the subject of the action, and tending to render the judgment ineffectual, and only when: (x) the complaint in the action is verified, and shows facts entitling the plaintiff to the relief demanded; and (y) the plaintiff files with the clerk or judge of the court in which the action is pending a bond executed to the party enjoined, in an amount to be fixed by the court, to the effect that the plaintiff will pay to such party all damages which he may sustain by reason of the injunction if the court should finally decide that the plaintiff was not entitled thereto. A preliminary injunction may also be obtained from the BLA based on substantially the same grounds and requirements as mentioned above.

(ii) A permanent (final) injunction would be granted if the plaintiff prevails in the action before the RTC or the BLA. Judgments by the RTC granting an injunction are enforceable after their rendition and are not stayed by an appeal unless otherwise ordered by the trial court. On appeal from the judgment of the RTC, the appellate court at its discretion may order the

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patent practice, patent grants in the EU are deemed persuasive in influencing prosecution in the corresponding Philippine applications.

2 Patent Amendment

2.1 Can a patent be amended ex parte after grant, and if so, how?

Yes, by filing a request for an amendment of a patent with the Bureau of Patents (“BOP”) of the IPOPHL.

2.2 Can a patent be amended in inter partes revocation/invalidity proceedings?

Yes, if the Committee of Three (composed of the BLA Director and two members who have the experience or expertise in the field of technology to which the patent sought to be cancelled relates), before whom the petition for cancellation is heard, finds that the patent and the invention to which it relates meet the requirements of the IP Code.

2.3 Are there any constraints upon the amendments that may be made?

Yes, there are. The patentee can only amend the patent under the following circumstances: (a) to limit the extent of protection conferred by it; (b) to correct obvious mistakes or clerical errors; and (c) to correct mistakes or errors, other than those referred to in point (b), made in good faith. For amendments that would result in the broadening of the extent of protection conferred by the patent, the request shall be made within two years from the grant of the patent and the change shall not affect the rights of any third party which has relied on the patent, as published. No amendments to the patent shall be permitted where the change would result in the disclosure contained in the patent going beyond the disclosure contained in the original application filed.

3 Licensing

3.1 Are there any laws which limit the terms upon which parties may agree a patent licence?

Yes, the relevant provisions of the IP Code on Voluntary Licensing require that licence agreements contain none of the prohibited clauses enumerated under Sec. 87 of the IP Code, which are deemed prima facie to have an adverse effect on competition and trade, and must include all the mandatory provisions listed in Sec. 88 of the IP Code.

3.2 Can a patent be the subject of a compulsory licence, and if so, how are the terms settled and how common is this type of licence?

Yes. The IPOPHL Director General may grant a licence to exploit a patented invention under certain conditions. The patentee shall be paid adequate remuneration, taking into account the economic value of the grant or authorisation or the need to correct the anti-competitive practice. In recent years, the grant of a compulsory licence has not been very common.

secured from the IPOPHL; (8) assessment of damages; (9) censure; and (10) other analogous penalties or sanctions.It is not likely that a Philippine tribunal would grant cross-border reliefs considering that patents are territorial rights, and thus applicable only in the Philippines, where the patent has been filed and granted in accordance with Philippine laws.

1.22 How common is settlement of infringement proceedings prior to trial?

It is fairly common for parties to pursue settlement discussions prior to proceeding to trial, primarily to avoid the costs and inconvenience of litigation. Moreover, the rules of procedure provide for alternative modes of dispute resolution, such as mediation, to encourage parties to open discussions for settlement.

1.23 After what period is a claim for patent infringement time-barred?

The patentee cannot recover damages for acts of infringement committed more than four years before the initiation of the action for infringement.

1.24 Is there a right of appeal from a first instance judgment, and if so, is it a right to contest all aspects of the judgment?

Yes. Final orders or decisions of the Regional Trial Court are, as a general rule, appealable to the Court of Appeals. Where only questions of law are raised or involved, the appeal shall be to the Supreme Court.Final orders or decisions of the BLA Director may be appealed to the Director General of the IPOPHL. The decision or order of the Director General of the IPOPHL may be appealed to the Court of Appeals.

1.25 What are the typical costs of proceedings to first instance judgment on (i) infringement, and (ii) validity? How much of such costs are recoverable from the losing party?

Depending on various factors, the costs of filing and prosecuting an infringement action before the RTC range from US$200,000 to US$500,000, while it would cost anywhere from US$100,000 to US$200,000 if filed before the BLA. A patent cancellation case before the BLA would cost around US$50,000 to US$150,000. A prevailing party may be allowed to recover from the damages caused by the infringer, attorneys’ fees and other expenses of litigation.

1.26 For jurisdictions within the European Union: What steps are being taken in your jurisdiction towards ratifying the Agreement on a Unified Patent Court, implementing the Unitary Patent Regulation (EU Regulation No. 1257/2012) and preparing for the unitary patent package? For jurisdictions outside of the European Union: Are there any mutual recognition of judgments arrangements relating to patents, whether formal or informal, that apply in your jurisdiction?

The Philippines does not have any formal mutual recognition of judgments arrangements relating to patents; however, since the current local patent practice is primarily patterned after the European

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application, while issues regarding patent ownership are matters left for judicial determination by competent courts.

5.6 Is there a “grace period” in your jurisdiction, and if so, how long is it?

The IPOPHL provides grace periods for the following:(a) Late payment of the annual fee – a grace period of six months

shall be granted for the payment of the annual fee, upon payment of the prescribed surcharge for delayed payment.

(b) Renewal of the term of an industrial design registration – a grace period of six months shall be granted for payment of the renewal fees after such expiration, upon payment of a surcharge.

5.7 What is the term of a patent?

The term of a Philippine patent is 20 years from the actual filing date (for non-PCT applications) or 20 years from the international filing date (for national phase applications of PCT applications).

6 Border Control Measures

6.1 Is there any mechanism for seizing or preventing the importation of infringing products, and if so, how quickly are such measures resolved?

Yes. The Bureau of Customs (“BOC”) keeps registry books for patents, trademarks, and copyrights. The Customs Examiners conduct actual examinations of the suspected cargo or shipment and immediately submit a recommendation to the Commissioner of Customs for the issuance of a Warrant of Seizure and Detention against such cargo and shipment. Goods finally found in seizure proceedings to be counterfeit or infringing are forfeited in favour of the government and are destroyed, unless the same is used as evidence in court proceedings.

7 Antitrust Law and Inequitable Conduct

7.1 Can antitrust law be deployed to prevent relief for patent infringement being granted?

Yes, it can.

7.2 What limitations are put on patent licensing due to antitrust law?

See the answer to question 3.1.

8 Current Developments

8.1 What have been the significant developments in relation to patents in the last year?

The IPOPHL and the EPO launched the Patent Prosecution Highway Pilot Programme on 1 July 2017. The PPH pilot programme will run for an initial period of three (3) years.PPH is a global work-sharing framework that enables patent applicants whose applications have been considered allowable

4 Patent Term Extension

4.1 Can the term of a patent be extended, and if so, (i) on what grounds, and (ii) for how long?

No, the term of a Philippine patent cannot be extended.

5 Patent Prosecution and Opposition

5.1 Are all types of subject matter patentable, and if not, what types are excluded?

Not all types of subject matter are patentable under the IP Code. The following are considered non-patentable: (a) discoveries, scientific theories, mathematical methods and, in the case of drugs and medicines, the mere discovery of a new form or new property of a known substance which does not result in the enhancement of the known efficacy of that substance, or the mere discovery of any new property or new use for a known substance or the mere use of a known process, unless such known process results in a new product that employs at least one new reactant; (b) schemes, rules and methods of performing mental acts, playing games or doing business, and programs for computers; (c) methods for treatment of the human or animal body by surgery or therapy and diagnostic methods practised on the human or animal body; (d) plant varieties or animal breeds or essentially biological processes for the production of plants or animals; (e) aesthetic creations; and (f) anything which is contrary to public order or morality. For the purposes of subsection (a), salts, esters, ethers, polymorphs, metabolites, pure form, particle size, isomers, mixtures of isomers, complexes, combinations, and other derivatives of a known substance, shall be considered to be the same substance unless they differ significantly in properties with regard to efficacy.

5.2 Is there a duty to the Patent Office to disclose prejudicial prior disclosures or documents? If so, what are the consequences of failure to comply with the duty?

No, there is no such duty.

5.3 May the grant of a patent by the Patent Office be opposed by a third party, and if so, when can this be done?

No. Pre-grant opposition actions are not available in the Philippines. However, any third party may present observations in writing concerning the patentability of the invention any time after the publication of an unexamined application.

5.4 Is there a right of appeal from a decision of the Patent Office, and if so, to whom?

The decision of the IPOPHL Director General may be appealed to the Court of Appeals.

5.5 How are disputes over entitlement to priority and ownership of the invention resolved?

Disputes over entitlement to priority date are usually dealt with ex parte by the IPOPHL during the prosecution of the patent

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Strategy (“NIPS”) Project on 30 May 2017 in Makati City, which is expected to be finalised by April 2018. The NIPS Project aims to craft deliberate and focused strategic approaches to address issues and concerns that hinder Filipinos from benefiting fully from the IP system.

8.3 Are there any general practice or enforcement trends that have become apparent in your jurisdiction over the last year or so?

There is an increasing trend towards resolving administrative complaints and disputes brought before the IPOPHL through mediation and amicable settlement. The IPOPHL also appears to be strengthening its capabilities in IP enforcement.

by a patent office to request the preferential examination of the corresponding applications in another patent office based on the examination results issued by a PPH office. Patent applicants follow a simple procedure when making the request. One other aspect of PPH that facilitates the prosecution of patent applications is that work products from one IP Office can be used as a reference by another IP Office in conducting substantive examination in the corresponding applications.

8.2 Are there any significant developments expected in the next year?

The IPOPHL, in collaboration with the World Intellectual Property Organization (“WIPO”), launched the National Intellectual Property

SyCip Salazar Hernandez & Gatmaitan Philippines

SyCip Salazar Hernandez & Gatmaitan (“SyCipLaw”) was founded in 1945. It is the largest law firm in the Philippines. It has offices in Makati City, the country’s business and financial centre, as well as Cebu, Davao and the Subic Freeport.

We offer a broad and integrated range of legal services, covering the following fields: banking, finance and securities; special projects; corporate services; general business law; tax; intellectual property; employment and immigration; and dispute resolution.

We have specialists in key practice areas such as mergers and acquisitions, energy, power, infrastructure, natural resources, transportation, government contracts, real estate, insurance, international arbitration, mediation, media, business process outsourcing, and technology.

We represent clients from almost every industry and enterprise, and the firm’s client portfolio includes local and global business leaders. We also act for governmental agencies, international organisations, and non-profit institutions.

Vida M. Panganiban-AlindoganSyCip Salazar Hernandez & GatmaitanSyCipLaw Center, 105 Paseo de RoxasMakati City 1226Philippines

Tel: +632 982 3500, 982 3600, 982 3700Email: [email protected]: www.syciplaw.com

Vida M. Panganiban-Alindogan is a partner at SyCip Salazar Hernandez & Gatmaitan, one of the largest general practice law firms in the Philippines. Her practice area includes the management, prosecution and enforcement of intellectual property rights. Ms. Panganiban-Alindogan is the treasurer of the Licensing Executives Society of the Philippines. She is a member of the Intellectual Property Association of the Philippines, the Asian Patent Attorneys Association and the International Trademark Association.

Ms. Panganiban-Alindogan received her Bachelor of Laws degree from the San Beda College of Law in 1995. She was admitted to the Philippine Bar in 1996.

Enrique T. ManuelSyCip Salazar Hernandez & GatmaitanSyCipLaw Center, 105 Paseo de RoxasMakati City 1226Philippines

Tel: +632 982 3500, 982 3600, 982 3700Email: [email protected]: www.syciplaw.com

Enrique T. Manuel, a senior partner and Head of the Intellectual Property Department at SyCip Salazar Hernandez & Gatmaitan, one of the largest law firms in the Philippines, has been an intellectual property practitioner for almost 30 years. Mr. Manuel is a member of the Board of Trustees of the Intellectual Property Association of the Philippines (“IPAP”), the national organisation of lawyers and practitioners engaged in the practice of intellectual property law in the Philippines. Mr. Manuel is likewise a member of the Board of Trustees of the Licensing Executives Society of the Philippines, the local society of LES International, a worldwide federation of professionals involved in the transfer of technology, industrial and intellectual property rights. He is a member of the Asian Patent Attorneys Association, the International Trademark Association and the International Association for the Protection of Intellectual Property (“AIPPI”).

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Chapter 20

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Romania

either of the parties, order an expert report to be prepared by court-appointed experts.

1.5 How are arguments and evidence presented at the trial? Can a party change its pleaded arguments before and/or at trial?

Modifications to the claim are allowed up until the first hearing. Arguments and evidence are presented in writing and in oral pleadings.

1.6 How long does the trial generally last and how long is it before a judgment is made available?

The ordinary course of proceedings takes one to four years before the issuance of a definitive solution. The judge should issue a reasoning of the judgment within 30 days upon the announcement of the latter.

1.7 Are judgments made available to the public? If not as a matter of course, can third parties request copies of the judgment?

The reasoning of the judgment is not publicly available, but its dispositive part is published on the court’s website.

1.8 Are there specialist judges or hearing officers, and if so, do they have a technical background?

Patent disputes are solved by judges specialised in intellectual property matters. However, although they are not required to have a technical background, some do.

1.9 What interest must a party have to bring (i) infringement, (ii) revocation, and (iii) declaratory proceedings?

The interest of the claimant must be qualified as: (i) direct; (ii) born; (iii) present; or (iv) personal:(a) Infringement: The claimant must produce evidence that it

is either the patent-owner or the exclusive licensee or, if it has a nonexclusive licence, that it has the consent and/or acts together with the patent-owner. Also, it must show the particulars on how the patent infringement is affecting its own rights.

1 Patent Enforcement

1.1 Before what tribunals can a patent be enforced against an infringer? Is there a choice between tribunals and what would influence a claimant’s choice?

The Romanian court system is hierarchically organised as follows: First Instance Courts; Tribunals; Courts of Appeal; and the High Court of Cassation and Justice. In case of an infringement, depending on the claim value, the material competence belongs to the First Instance Courts (claims with a value lower than €45,000) or Tribunals (claims over €45,000). The owner or the licensee has a choice between the courts of the region where his own headquarters are located, the infringer’s location, the place where the infringing acts occurred, or where the damages are produced.

1.2 What has to be done to commence proceedings, what court fees have to be paid and how long does it generally take for proceedings to reach trial from commencement?

The claim has to be filed together with all supporting evidence. The stamp duty is less than €100 and a first hearing is usually established within one month from the claim’s registration. If the claimant is seeking damages, a stamp duty calculated based on the claim value is due.

1.3 Can a party be compelled to disclose relevant documents or materials to its adversary either before or after commencing proceedings, and if so, how?

Procedural law provides the cases for when disclosure of certain documents held by the defendant is allowed. A disclosure order is usually issued, during the trial, by the panel solving the merits of the case.

1.4 What are the steps each party must take pre-trial? Is any technical evidence produced, and if so, how?

A cease and desist letter is common practice but not mandatory. Pre-trial, the owner should collect the written evidence in support of its infringement claim. It is not mandatory, but it is advisable that the claimant produce an ex parte expert report on the existence and/or the extent of the infringement. The court may, upon request of

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1.17 What other grounds of defence can be raised in addition to non-infringement or invalidity?

The grounds for defence vary depending on the factual context, and include statute of limitation, exhaustion of rights, prior use rights, existence of a licence, experimental use, etc.

1.18 Are (i) preliminary, and (ii) final injunctions available, and if so, on what basis in each case? Is there a requirement for a bond?

Preliminary injunctions are available temporarily, in urgent cases, for preventing an imminent and irremediable damage or the loss of a certain right that could be damaged by delay. If launched before the infringement claim, the court may order the main claim to be launched within a very short deadline after the PI’s granting. Failure to observe the deadline results in the loss of the temporary measure.The court may also condition the issuance of the PI on the payment of a bond. Romanian law does not recognise final injunctions.

1.19 On what basis are damages or an account of profits assessed?

The claimant must produce its own calculations and proofs of the damage; however, the courts are currently ordering accounting expertise reports to be produced by court-appointed experts. There are several methods for assessing the damage and certain legal criteria to be followed by courts and experts, such as the determination of the actual financial loss incurred by the grieving party, the unjust benefits realised by the infringer, the value of the licence rights, etc.

1.20 How are orders of the court enforced (whether they be for an injunction, an award of damages or for any other relief)?

Court decisions are enforced by recourse to a judicial bailiff. Usually, the judicial bailiff will serve the infringer a notice to comply. In the case of injunctions, upon the claimant’s request, the court may order enforcement of the decision without any notice or delay. Procedural law provides that the bailiff may use several means such as an attachment of the movable assets, a garnishment of the infringers’ bank accounts, etc.

1.21 What other form of relief can be obtained for patent infringement? Would the tribunal consider granting cross-border relief?

The measures against infringement include the destruction of the infringing products, their confiscation, the seizure of these and of materials and machines used for producing them, their withdrawal from the distribution channels, blocking of the accounts of the infringer, etc. Romanian law also considers infringing activity a criminal offence.

1.22 How common is settlement of infringement proceedings prior to trial?

Settlement before the launching of the infringement claim is not common, though not excluded.

(b) Revocation: The patent law uses the expression “any person”, which implies that the claim has an objective nature. However, the procedural law requires that any claimant must show a characterised interest.

(c) Declaratory proceedings are not available.

1.10 If declarations are available, can they address (i) non-infringement, and/or (ii) claim coverage over a technical standard or hypothetical activity?

This is not applicable in Romania.

1.11 Can a party be liable for infringement as a secondary (as opposed to primary) infringer? Can a party infringe by supplying part of, but not all of, the infringing product or process?

The law defines infringement restrictively (direct infringement), but provides the same sanctions and measures (such as confiscation, destruction, etc.) against an indirect infringer.

1.12 Can a party be liable for infringement of a process patent by importing the product when the process is carried on outside the jurisdiction?

Yes, a party can be held liable for such.

1.13 Does the scope of protection of a patent claim extend to non-literal equivalents?

The law provides for both literal infringement and infringement by equivalents. An element is deemed as equivalent to an element specified in the claims if, for a person skilled in the art, it is obvious that by using it, essentially the same result is obtained.

1.14 Can a defence of patent invalidity be raised, and if so, how? Are there restrictions on such a defence e.g. where there is a pending opposition?

Yes, it can be raised by way of a counterclaim together with the statement of defence in advance of the first hearing. No, an invalidity action can be filed irrespective of pending opposition proceedings.

1.15 Other than lack of novelty and inventive step, what are the grounds for invalidity of a patent?

In addition to a lack of novelty and inventive step, a patent can be invalidated where the subject matter of the patent is not considered an invention, is excluded from patentability, has no industrial application, does not disclose the invention in a manner sufficiently clear and complete for it to be carried out by a person skilled in the art, for added subject matter, inadmissible extension or the patent-owner is not the person entitled to the grant of the patent.

1.16 Are infringement proceedings stayed pending resolution of validity in another court or the Patent Office?

The court may decide to stay the infringement until the invalidity claim or the opposition decision is final.

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3 Licensing

3.1 Are there any laws which limit the terms upon which parties may agree a patent licence?

No. As a general rule, the patent licence terms are subject to the general terms and conditions set out in the Civil Code. Also, there may be limitations stipulated by competition and antitrust law.

3.2 Can a patent be the subject of a compulsory licence, and if so, how are the terms settled and how common is this type of licence?

The grounds for granting a compulsory licence include: insufficient exploitation of the patent; national emergency cases; other cases of extreme emergency; and cases of public use for non-commercial purposes.

4 Patent Term Extension

4.1 Can the term of a patent be extended, and if so, (i) on what grounds, and (ii) for how long?

As an exception, the term of a patent can be extended only for patented medicinal products or for plant protection products, for which a supplementary protection certificate (SPC) may be granted under Regulation (EC) no. 469/2009, Regulation (EC) no. 1610/96 and Regulation (EC) no. 1901/2006. It extends the term of the patent for up to a maximum of five years and an additional six months in case of paediatric medicines.

5 Patent Prosecution and Opposition

5.1 Are all types of subject matter patentable, and if not, what types are excluded?

A patent shall be granted for virtually any invention having as its subject matter a product or process, in all technological fields. However, the following are not considered inventions: ■ discoveries, scientific theories and mathematical methods;■ aesthetic creation;■ schemes, rules and methods for performing mental acts,

playing games or doing business, as well as computer programs; and

■ presentation of information.Also, a patent shall not be granted for inventions:■ considered against public morals, harmful to health or life;■ which are plant varieties and animal breeds;■ having as a subject matter the human body, as well as the

mere discovery of one of its elements, including the sequence or partial sequence of a gene; and

■ which are methods of treatment concerning the human or animal body, by surgery or therapy and diagnostic methods.

5.2 Is there a duty to the Patent Office to disclose prejudicial prior disclosures or documents? If so, what are the consequences of failure to comply with the duty?

No, there is no such duty.

1.23 After what period is a claim for patent infringement time-barred?

The limitation period is normally three years starting from the moment the claimant has knowledge about the damage and the person infringing the patent. This period is interrupted by filing a civil action. However, there is no unitary jurisprudence on this topic.

1.24 Is there a right of appeal from a first instance judgment, and if so, is it a right to contest all aspects of the judgment?

A decision issued by a Tribunal may be challenged before the Court of Appeal, both on the case’s legal and factual aspects. The Court of Appeal’s decision may be challenged before the High Court of Cassation and Justice, but only on its legal aspects.

1.25 What are the typical costs of proceedings to first instance judgment on (i) infringement, and (ii) validity? How much of such costs are recoverable from the losing party?

The stamp duty is fixed depending on legal criteria: i) there is a fixed fee of less than €100 for infringement and invalidity; and ii) calculated based on the value of the claim for damages claims. The court fees, stamp duty and expert fees are recovered in full. The judges may reduce the attorney fees.

1.26 For jurisdictions within the European Union: What steps are being taken in your jurisdiction towards ratifying the Agreement on a Unified Patent Court, implementing the Unitary Patent Regulation (EU Regulation No. 1257/2012) and preparing for the unitary patent package? For jurisdictions outside of the European Union: Are there any mutual recognition of judgments arrangements relating to patents, whether formal or informal, that apply in your jurisdiction?

This is not applicable in Romania.

2 Patent Amendment

2.1 Can a patent be amended ex parte after grant, and if so, how?

Yes. The making of amendments to national patents, known as the limitation procedure, with the view to reducing the scope of the patent, can be made before the Romanian Patent Office within three months after the grant date.

2.2 Can a patent be amended in inter partes revocation/invalidity proceedings?

Yes. Romanian Patent Law allows the amendment of a patent both in revocation proceedings before the Romanian Patent Office, as well as in invalidity proceedings before the national courts.

2.3 Are there any constraints upon the amendments that may be made?

Yes. The amended claims should have support in the patent’s description and they cannot be broader than the initial claims.

Nestor Nestor Diculescu Kingston Petersen Romania

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Consequently, following the Huawei Technologies Co. v. ZTE Corp. (Case C-170/13) judgment, the Bucharest Court of Appeal, although indirectly, took into consideration the criteria set out in the latter judgment in Vringo v. ZTE. The case regarded ZTE’s request that the courts revoke a preliminary injunction Vringo had obtained against ZTE relating to a standard-essential patent, which remained in effect. The national courts give thorough consideration to every reason held by the CJEU in its decisions regarding this subject and, thus, will take into account the CJEU’s case-law that the exercise of an exclusive right linked to an intellectual property right by the proprietor may, in exceptional circumstances, involve abusive conduct for the purposes of Article 102 TFEU.

7.2 What limitations are put on patent licensing due to antitrust law?

Domestic law does not provide for any express limitation on patent licensing due to antitrust law. Nevertheless, the patent law sets out the right of a competitor to submit in front of the Bucharest Tribunal a request for a compulsory licence. Thus, the Tribunal is empowered to issue a compulsory licence in order to put an end to a practice which alters the competition on the market. In this case, other conditions provided for a regular compulsory licence such as (i) failure to agree on the conditions of the licence, or (ii) the granting of compulsory licences in cases of emergency or public utility do not apply. We may therefore say that, in an implicit manner, the right of exclusive use/exploitation is limited by antitrust good practices. Moreover, EU Regulation 316/2014 providing for the exclusion of pricing restrictions and limiting production is directly applicable in front of the national courts.

8 Current Developments

8.1 What have been the significant developments in relation to patents in the last year?

Romania signed the Protocol for the Provisional Application of the Unified Patent Court Agreement on September 14, 2016 and is in the process of finalising the draft law on the ratification of the Agreement on the Unified Patent Court, opened for signature and signed by Romania in Brussels on February 19, 2013, and the ratification of the Protocol on the Provisional Application of the Unified Court Agreement Patents, opened for signature on October 1, 2015 and signed by Romania in Brussels on September 14, 2016.

8.2 Are there any significant developments expected in the next year?

The most important subject is the possibility of the legal implementation of the Unified Patent Court with or without the United Kingdom. Depending on the evolution of the Unitary Patent system, Romania will finalise the draft law in order to ratify the Unified Patent Court Agreement.

8.3 Are there any general practice or enforcement trends that have become apparent in your jurisdiction over the last year or so?

At present, there is an upward trend in Romania of the submission of IT&C patent applications and we expect an increased volume of litigation in the telecommunication sector.

5.3 May the grant of a patent by the Patent Office be opposed by a third party, and if so, when can this be done?

Yes. Any interested person may lodge a request for the revocation of a patent within six months from the publication of the mention of granting the patent.

5.4 Is there a right of appeal from a decision of the Patent Office, and if so, to whom?

Yes. The decisions of the Romanian Patent Office (of the Board of Appeal) shall be appealed before the Bucharest Tribunal within 30 days from their communication. The decisions of the Bucharest Tribunal may be challenged only before the Bucharest Court of Appeal.

5.5 How are disputes over entitlement to priority and ownership of the invention resolved?

Disputes concerning the status of an inventor, patent-owner or other rights arising from the patent, including the economic rights of the inventor under assignment or licence contracts, shall fall within the jurisdiction of the courts of law.

5.6 Is there a “grace period” in your jurisdiction, and if so, how long is it?

There is no such grace period.

5.7 What is the term of a patent?

The term of a patent is 20 years from the date of filing the application. The term can be extended under certain conditions – see the answer to question 4.1.

6 Border Control Measures

6.1 Is there any mechanism for seizing or preventing the importation of infringing products, and if so, how quickly are such measures resolved?

EU Regulation 608/2013 of the European Parliament and of the Council concerning customs enforcement of intellectual property rights applies. A decision granting or rejecting an application is taken within 30 working days.

7 Antitrust Law and Inequitable Conduct

7.1 Can antitrust law be deployed to prevent relief for patent infringement being granted?

Antitrust law, as provided under EU Regulations, Directives and Article 102 TFEU is applied by national courts in accordance with the CJEU’s case-law.

RomaniaNestor Nestor Diculescu Kingston Petersen

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Also, with the awareness of the economic potential of a patent, the number of requests for assistance in the field of employees’ inventions has registered a slight increase.

AcknowledgmentThe authors would like to thank Adina Badarau and Anca Deaconu for their assistance in preparing this chapter.

RomaniaNestor Nestor Diculescu Kingston Petersen

Ana-Maria BaciuNestor Nestor Diculescu Kingston PetersenGlobalworth Tower, 18th Floor201 Barbu Vacarescu St.District 2, Bucharest 020276Romania

Tel: +40 21 201 12 00Email: [email protected]: www.nndkp.ro

Sorina OlaruNestor Nestor Diculescu Kingston PetersenGlobalworth Tower, 18th Floor201 Barbu Vacarescu St.District 2, Bucharest 020276Romania

Tel: +40 21 201 12 00Email: [email protected]: www.nndkp.ro

NNDKP’s intellectual property arm (NNDKP IP) is recognised on the Romanian IP market as being the largest group of specialised IP practitioners among the law firms active in Romania.

We deliver the in-depth IP knowledge more commonly associated with boutique IP firms, coupled with the resources and wider commercial perspective of NNDKP which offers integrated legal & tax services.

In terms of patents, clients enjoy a balanced mix of legal and technological savvy needed to pursue their business objectives, from their creation to marketing. Also, together with NNDKP litigation team, our patent practitioners have a long and successful track record of litigation work.

NNDKP IP is the most frequently awarded and highest ranked team in the Romanian jurisdiction by specialised IP research guides. For example, NNDKP IP received the IP Law firm of the Year in Romania award at the MIP Gala between 2014–2017 (the only firm in Romania to have been awarded this distinction four times).

Ana-Maria Baciu has 18 years of experience in international and domestic business law. She heads the firm’s IP practice and advises clients on the full spectrum of intellectual property matters, including in relation to trademarks, designs, domain names, copyright, patents, enforcements and border measures, transactions with an IP component. She also advises on specific aspects regarding advertising, labelling or promotional campaigns mechanisms.

Ana-Maria was recently included in “Top 250 Women in IP” by the Managing Intellectual Property – IP Stars 2017 edition. The list recognises female IP practitioners in private practice who have performed exceptionally for their clients and firms in the past year.

Individual recognition in prestigious legal guides in 2017:

■ recommended individual in IAM Patent 1000;

■ gold recommended individual in WTR1000;

■ ranked in Band 1 as a Leading Individual in IP in Chambers Europe; and

■ ranked in Tier 1 as a Leading Individual in IP in The Legal 500 EMEA.

Sorina Olaru is a well-versed professional in intellectual property-related disputes including patents, with a focus on the pharmaceuticals sector. In addition to her IP specialisation, Sorina is an exceptional pleading lawyer and arbitrator, with extensive expertise (more than 18 years) in complex dispute resolution cases. She continuously represents major international corporations, global leaders in their sectors, in administrative and competition disputes, regulatory and licensing disputes.

She is a member of the Board of the Court of International Commercial Arbitration attached to the Chamber of Commerce and Industry of Romania and a member of the ICC National Committee for Romania.

Sorina is recognised as a highly recommended individual in the 2017 edition of IAM Patent 1000, the world’s leading patent guide. Also, she is top-ranked in other renowned legal guides from 2017 such as WTR1000, Chambers Europe and The Legal 500 EMEA.

Adina Badarau is a Senior Patent Attorney at NNDKP specialising in intellectual property. Tel: +40 21 201 12 00 / Email: [email protected] Deaconu is a Senior Patent Attorney at NNDKP specialising in intellectual property. Tel: +40 21 201 12 00 / Email: [email protected]

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Chapter 21

1 Patent Enforcement

1.1 Before what tribunals can a patent be enforced against an infringer? Is there a choice between tribunals and what would influence a claimant’s choice?

A patent can be enforced before: a Commercial Court, which is for patent disputes relating to business activities (usually when the parties are legal entities or self-employed entrepreneurs); a general jurisdiction court, which is for other kinds of patent disputes; or the Federal Antimonopoly Service.

1.2 What has to be done to commence proceedings, what court fees have to be paid and how long does it generally take for proceedings to reach trial from commencement?

To commence proceedings, a lawsuit must be filed with the court. The amount of court fees depends on the compensation claimed, and also on whether there are other (non-monetary) claims. It takes 30 days for a preliminary arrangement (for a Commercial Court) and 30–45 days for the appointment of the first hearing date.

1.3 Can a party be compelled to disclose relevant documents or materials to its adversary either before or after commencing proceedings, and if so, how?

There is no procedure before commencing proceedings. There is a requirement, once proceedings have started, for the parties to submit all relevant documents. The parties can also review any materials submitted to the court. It is possible to seek an order to secure evidence.

1.4 What are the steps each party must take pre-trial? Is any technical evidence produced, and if so, how?

A complaint must be submitted to an infringer. Only after the expiration of a 30-day period following this, can a lawsuit be filed with the court. The court may order an expert assessment to be made. Evidence of sending a cease-and-desist (C&D) letter has to be demonstrated. Also, in the Commercial Court, the plaintiff should provide the corporate registration documents for both himself and the defendant (which could be extracts from the Commercial Registry). These documents confirm the territorial jurisdiction of the court and the existence of a proper defendant.

1.5 How are arguments and evidence presented at the trial? Can a party change its pleaded arguments before and/or at trial?

Written and real evidence, explanations, expert opinions, consult-ations of specialists, witness testimonies, sound recordings and videotapes, and other documents and materials are admitted as evidence. Copies of documents submitted to the court should be forwarded to other persons participating in the case, if they do not have these documents. Securing of evidence is also possible through an application to court. Either grounds or claims can be changed in the court of first instance before issuance of the final decision, but it is not possible to change both grounds and claims.

1.6 How long does the trial generally last and how long is it before a judgment is made available?

The trial generally takes three to six months, but may last longer if an expert assessment is ordered. The judgment is made within five days from the final session and must be made available on the court’s website the next day. In practice, this term can be longer.

1.7 Are judgments made available to the public? If not as a matter of course, can third parties request copies of the judgment?

Yes, judgments are published on the court’s website. Normally, third parties cannot request certified copies of the judgment.

1.8 Are there specialist judges or hearing officers, and if so, do they have a technical background?

There are no specialist judges or hearing officers. Judges normally do not have a technical background. However, judges with such experience may be found in the specialised IP Court, which deals with cases of patent enforcement as a court of third instance and also with cases where decisions of state administrative departments in the field of IP are contested; for example, the Chamber for Patent Disputes or the Federal Antimonopoly Service.

1.9 What interest must a party have to bring (i) infringement, (ii) revocation, and (iii) declaratory proceedings?

(i) A party must be a patentee or, in certain cases, an exclusive licensee.

Andrey Cherkasov

Maxim Sobolev

Rouse & Co. International (UK) Limited (Moscow Branch)

Russia

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■ If someone who is not an inventor or patentee is indicated as such in a patent, or if a real inventor or patentee is not indicated in a patent.

1.16 Are infringement proceedings stayed pending resolution of validity in another court or the Patent Office?

Courts can, but do not have to, stay proceedings pending resolution of validity in the Chamber for Patent Disputes.

1.17 What other grounds of defence can be raised in addition to non-infringement or invalidity?

Other grounds of defence include: ■ Acts carried out for non-commercial purposes (such as

scientific research).■ Temporary introduction of the invention by means of

transport.■ Use in emergency circumstances (such as disasters).■ The one-off manufacturing of medicines in certain

circumstances.■ Exhaustion of rights.■ Good-faith prior use.■ Right of after-use (if a patent lapsed and was then reinstated).■ Use in the interests of national security.

1.18 Are (i) preliminary, and (ii) final injunctions available, and if so, on what basis in each case? Is there a requirement for a bond?

(i) Preliminary injunction is available by an application. The court may demand a bond upon the motion of the defendant or on its own initiative.

(ii) Final injunction is also available; no bond is required.

1.19 On what basis are damages or an account of profits assessed?

Damages include: the expenses which the plaintiff incurred or will have to incur to restore the violated right; the loss or the damage done to his property (the real loss); as well as the missed profit. In practice, it is very difficult to evidence damages. Instead of damages, compensation from RUB 10,000 to 5,000,000 – depending on the type and character of infringement – can be claimed.

1.20 How are orders of the court enforced (whether they be for an injunction, an award of damages or for any other relief)?

A decision of a court is executed after it enters into force, with the exception of immediate execution. The decision of the court should be enforced by the defendant voluntarily, otherwise enforcement proceedings can be initiated by contacting the state bailiff executors.

1.21 What other form of relief can be obtained for patent infringement? Would the tribunal consider granting cross-border relief?

Instead of damages, a patentee may claim compensation from the infringer – see question 1.19. In this case, the patentee is relieved from the duty to evidence damages. Other options include: seizure

(ii) Revocation proceedings can be brought by any party by filing an opposition with the Chamber for Patent Disputes. After the expiration of a patent, it can only be invalidated by an interested party.

(iii) Declaratory proceedings can be brought by any party (on limited grounds and based on establishing a legally significant fact (not a hypothetical activity) – see question 1.10).

1.10 If declarations are available, can they address (i) non-infringement, and/or (ii) claim coverage over a technical standard or hypothetical activity?

These types of declaratory claims cannot be addressed in Russia.

1.11 Can a party be liable for infringement as a secondary (as opposed to primary) infringer? Can a party infringe by supplying part of, but not all of, the infringing product or process?

Secondary or contributory liability is not expressly provided for in the patent legislation. Yet there is nothing to prevent a patentee acting against a mere retailer, storage service, transport company, customs broker, wholesale distributor, etc. However, the amount of liability is estimated by the court based on the type and character of the infringement.

1.12 Can a party be liable for infringement of a process patent by importing the product when the process is carried on outside the jurisdiction?

Yes. Patentee rights include the right to prevent the importation of products made using the patented process.

1.13 Does the scope of protection of a patent claim extend to non-literal equivalents?

Yes for patents for inventions; no for patents for utility models.

1.14 Can a defence of patent invalidity be raised, and if so, how? Are there restrictions on such a defence e.g. where there is a pending opposition?

Yes. A patent can be invalidated by filing an opposition with the Chamber for Patent Disputes. There are no restrictions on such a defence.

1.15 Other than lack of novelty and inventive step, what are the grounds for invalidity of a patent?

A patent can also be invalidated in the following cases:■ If an invention or utility model does not meet the requirement

of industrial applicability.■ If an invention or utility model is not patentable for the

reasons disclosed in question 5.1.■ If an invention or utility model is not disclosed in the

application materials on the filing date fully enough to be realised by a skilled person.

■ If there are features in claims not disclosed in the application materials on the filing date.

■ If a patent is granted when there are several applications for identical inventions or utility models with the same priority date.

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2 Patent Amendment

2.1 Can a patent be amended ex parte after grant, and if so, how?

It cannot. The patentee, however, may cancel some of the patent claims by application to the Patent Office.

2.2 Can a patent be amended in inter partes revocation/invalidity proceedings?

Yes; if a patent is to be revoked in full, the Chamber for Patent Disputes may invite the patentee to propose some amendments to claims. If the patent is amended in this way, this means it is revoked in part. In practice, only the cancellation of some claims or features is allowed.

2.3 Are there any constraints upon the amendments that may be made?

Such amendments must comply with all the requirements applicable in examination. In particular, they must not modify the essence of the invention or utility model.

3 Licensing

3.1 Are there any laws which limit the terms upon which parties may agree a patent licence?

According to the Civil Code, the term for which the licence is concluded must not exceed the effective term of the patent. Free exclusive licences between commercial organisations are not allowed unless otherwise provided. There are also certain requirements for agreements themselves. For example, a fee-based licence must include a clause on the amount of the fee or on the procedure for setting it. Granting the right to use the invention or utility model is subject to recordal with the Registry for this right to have effect.

3.2 Can a patent be the subject of a compulsory licence, and if so, how are the terms settled and how common is this type of licence?

Yes; compulsory (non-exclusive) licences are available four years after granting the patent for an invention and three years after granting the patent for a utility model, if the patent has not worked or has worked insufficiently, which has led to the insufficient provision of the relevant goods, works or services in the market, and the patentee has refused to secure a licence on reasonable commercial terms.The payments for a compulsory licence shall be set in the court’s decision as at least equal to a licence price determined in comparable circumstances.The court may also terminate a compulsory licence if the circumstances due to which the licence has been issued no longer exist and it is unlikely that they are going to appear again.Compulsory licences are not common.

of counterfeit; recognition of the right; stopping of the actions that infringe the right or create the threat of infringement thereof; and publication of a court decision on the infringement. No cross-border relief is available.

1.22 How common is settlement of infringement proceedings prior to trial?

In practice, 60–70% of cases are resolved at this stage.

1.23 After what period is a claim for patent infringement time-barred?

The claim is time-barred upon the expiration of three years from the day when the patentee learned, or should have learned, about the violation of their right. This limiting period is not applicable to continuing violations.

1.24 Is there a right of appeal from a first instance judgment, and if so, is it a right to contest all aspects of the judgment?

Yes; an appeal may be filed within one month after the delivery of the disputed decision by a court of the first instance. All aspects of the judgment can be contested.

1.25 What are the typical costs of proceedings to first instance judgment on (i) infringement, and (ii) validity? How much of such costs are recoverable from the losing party?

Typical costs for (i) include court fees, experts, representation and other costs. They are all recoverable from the losing party at the discretion of the court. IP cases are considered difficult. Therefore, the cost for representation can be reimbursed in a much larger amount than for ordinary commercial disputes. Typical costs for (ii) include fees of the Chamber for Patent Disputes and experts, representation and other costs. None of these are recoverable. However, it is possible to reimburse representation costs for this type of case at the stages of appellation in the IP Court. Fees of the Chamber for Patent Disputes are about USD 50 for each violation of the legislation. Patent attorneys’ fees are normally at hourly rates and will vary greatly depending on the complexity of the case, whether or not the ‘prior art’ search is needed, and the like.

1.26 For jurisdictions within the European Union: What steps are being taken in your jurisdiction towards ratifying the Agreement on a Unified Patent Court, implementing the Unitary Patent Regulation (EU Regulation No. 1257/2012) and preparing for the unitary patent package? For jurisdictions outside of the European Union: Are there any mutual recognition of judgments arrangements relating to patents, whether formal or informal, that apply in your jurisdiction?

This is not applicable to Russia.

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5.4 Is there a right of appeal from a decision of the Patent Office, and if so, to whom?

Yes, there is an appeal to the courts.

5.5 How are disputes over entitlement to priority and ownership of the invention resolved?

Where two or more people claim the same invention, the first to file has priority. If these applications have the same priority date, a patent can be granted only on one of them to the person designated by agreement among the applicants. If this person is not designated, both applications will be considered withdrawn.A person who has had their invention misappropriated may seek the transfer of the patent to themselves through a court order. However, if a real patentee is not indicated in a patent, this is also a ground for invalidating it in full (see question 1.15).

5.6 Is there a “grace period” in your jurisdiction, and if so, how long is it?

Yes, the grace period is six months from the date of disclosure of an invention or utility model.

5.7 What is the term of a patent?

The term is 20 years from the date of filing. It can also be extended in some cases (see question 4.1).

6 Border Control Measures

6.1 Is there any mechanism for seizing or preventing the importation of infringing products, and if so, how quickly are such measures resolved?

Inventions and utility models cannot be included in the Customs IP Registry. However, infringing products can be seized by a court’s order.

7 Antitrust Law and Inequitable Conduct

7.1 Can antitrust law be deployed to prevent relief for patent infringement being granted?

Generally, no. Under the antitrust law, unfair competition by committing an economic activity of selling, exchanging or otherwise introducing of goods into circulation, if at the same time the results of intellectual activity were illegally used, is prohibited.

7.2 What limitations are put on patent licensing due to antitrust law?

There are no such limitations.

4 Patent Term Extension

4.1 Can the term of a patent be extended, and if so, (i) on what grounds, and (ii) for how long?

Yes; the term of a patent for a medicine, pesticide or agrochemical substrate (inventions only) can be extended if more than five years have elapsed from the filing of a patent application to the receipt of the first permission for using it.It is extended by this period, less five years, but not by more than five years. A term-extension application shall be filed by the patentee within the effective term of the patent before the expiry of six months after the receipt of the permission or the date of grant of the patent, whichever of these terms expires last.

5 Patent Prosecution and Opposition

5.1 Are all types of subject matter patentable, and if not, what types are excluded?

The following are excluded from patentability:■ discoveries;■ scientific theories and mathematical methods; ■ solutions concerning only the appearance of articles and

aimed at meeting aesthetic needs;■ the rules and methods of games and of intellectual or

economic activities; ■ computer programs; ■ solutions consisting in the presentation of information only;■ plant varieties, animal breeds and the biological methods for

producing them; that is, methods fully consisting of crossing or selection, except for microbiological methods and products produced by such methods;

■ integrated circuit layout designs;■ human cloning techniques;■ techniques for modifying the genetic integrity of human

embryo cells;■ uses of human embryos for industrial and commercial

purposes; and■ other developments inconsistent with the public interest and

humane and moral principles.

5.2 Is there a duty to the Patent Office to disclose prejudicial prior disclosures or documents? If so, what are the consequences of failure to comply with the duty?

The closest analogue (prototype) must be disclosed in the ‘Prior Art’ chapter of an application. If, during the patent search, the Patent Office finds a closer analogue, it may require that this be included in the application. Thus, there are no consequences other than for failure to respond to this requirement in a timely manner.

5.3 May the grant of a patent by the Patent Office be opposed by a third party, and if so, when can this be done?

Any person can apply to revoke the patent during the whole term of the patent.

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Chamber of Patent Attorneys, participation in which is compulsory. For now, the overwhelming majority of patent attorneys are opposed to this draft law and hope it will not be adopted.There are also debates about whether the law should provide specifically for filing so-called “provisional applications”, similar to those in the USA. In fact, there is already the possibility in Russia to claim priority similarly to how it is claimed in the USA, based on provisional applications, only such applications are not called ‘provisional’.It is also expected that new Regulations for the Chamber for Patent Disputes will come out instead of the pending ones, which are clearly outdated.

8.3 Are there any general practice or enforcement trends that have become apparent in your jurisdiction over the last year or so?

The order of pre-trial settlement in Commercial Courts (sending C&D letters) has become mandatory. There is a trend towards a further toughening of approaches to utility models, in addition to a number of the latest restricting amendments to the Russian Civil Code. Also, a new draft law is being considered, according to which it will be possible to impose interim measures from commencement – i.e. before filing a lawsuit.

8 Current Developments

8.1 What have been the significant developments in relation to patents in the last year?

By far the most important development to have taken place in 2016 was that new Regulations were adopted. They had been expected to clarify some debatable issues with the latest amendments to the Civil Code of the Russian Federation, introduced in 2014. Unfortunately, this did not happen, and there remain quite a few debatable issues in relation to patents. For example, the Civil Code now stipulates that application materials can be amended at the applicant’s initiative only once after receiving the search report, which is prepared during substantive examination. In fact, the current practice allows the application to be amended before formal examination is completed. Therefore, amendments filed later, together with the request for substantive examination, will not be accepted and should wait until the search report is received.

8.2 Are there any significant developments expected in the next year?

One important development is that the Law on Patent Attorneys is expected to be updated. The new draft law provides for one unified

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Rouse is a global IP leader specialising in the creation, management, commercialisation and enforcement of IP rights. Established in the United Kingdom in 1990, we now have 17 offices in Africa, Asia, Europe and the Middle East, as well as an associated office in Saudi Arabia. In October 2015, we launched an office in South Africa, making us the first global IP firm to launch in sub-Saharan Africa.

Having opened in 2013, our Moscow office is a recent addition to Rouse’s global business. This was in response to frequent requests from our clients to assist them in this region. From here we handle IP work throughout Russia, as well as the Commonwealth of Independent States. Our clients include major multinational blue-chip companies in the energy, manufacturing, automotive, pharmaceutical, technology and household and luxury goods sectors.

Significant clients of the firm’s Moscow office include: LPG Systems; KSR KUEBLER; Niveau-Messtechnik AG; Sony-Mobile; Procter & Gamble; Reckitt Benckiser; Richemont; Bourjois; Harley-Davidson; Nintendo; and DuPont.

Andrey Cherkasov specialises in the registration and enforcement of a wide range of IP rights in the Moscow office of Rouse. As a Trademark Attorney, he represents rights-holders before the Russian Patent and Trademark Office (Rospatent), as well as before courts. He also has extensive experience in dealing with customs and the anti-monopoly authorities on IP-related matters.

Initially, Andrey worked for a Russian law firm specialising in IP rights as they relate to IT, before moving on to an IP firm as a Trademark Attorney.

Before joining Rouse, Andrey was Deputy Head of the legal department of a major Russian food company. He managed their IP portfolio (both at national and international level) and was also responsible for enforcement and litigation procedures, including before the Supreme Arbitration Court and the IP Court of Russia.

Andrey CherkasovRouse & Co. International (UK) Limited(Moscow Branch)Office 410, 4th FloorBusiness Centre Ducat Place II7 Gasheka StreetMoscow 123056Russia

Tel: +7 495 230 03 37Email: [email protected]: www.rouse.com

Maxim Sobolev is a Russian Patent and Trademark Attorney and a Eurasian Patent Attorney in the Moscow office of Rouse. Maxim specialises in drafting, filing and prosecuting patent applications for inventions and utility models. He has worked with patents since 2000. Prior to joining Rouse, Maxim worked at another international law firm as a Patent Attorney. He has also worked as a Patent Examiner at the Russian Patent and Trademark Office (Rospatent), and was Head of Patents at one of the leading Russian pharmaceutical companies and at a Russian IP law firm. Maxim has extensive experience in drafting patent applications, filing PCT applications at the Russian national and Eurasian regional phases, advising clients on Office actions, preparing responses thereto, filing oppositions and preparing non-infringement/freedom-to-operate opinions.

Maxim SobolevRouse & Co. International (UK) Limited(Moscow Branch)Office 410, 4th FloorBusiness Centre Ducat Place II7 Gasheka StreetMoscow 123056Russia

Tel: +7 495 230 03 37Email: [email protected]: www.rouse.com

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Chapter 22

Rouse & Co. International/Kadasa & Partners

Saudi Arabia

1.3 Can a party be compelled to disclose relevant documents or materials to its adversary either before or after commencing proceedings, and if so, how?

There is no codified evidence law applicable in Saudi Arabia. Therefore, there are no provisions regulating the disclosure of relevant documents. The Saudi courts, including the Committee, apply in the absence of a provision governing the dispute or a specific issue, the general rules and Islamic principles observed in Saudi Arabia. It can be inferred from such general rules and the general understanding of existing regulations that the Committee can compel a party to disclose relevant documents or materials unless such disclosure violates the right of said party to protect its trade secrets and other protectable information.

1.4 What are the steps each party must take pre-trial? Is any technical evidence produced, and if so, how?

There are no specific pre-trial steps or requirements. Production of technical evidence is optional, and a party may obtain technical evidence to support its claims and position in the case. Nevertheless, such produced technical evidence does not bind the Committee which is entitled to seek the assistance of different expert bodies for whatever it deems necessary of the technical matters referred to it and to determine the party liable for the expenses incurred.

1.5 How are arguments and evidence presented at the trial? Can a party change its pleaded arguments before and/or at trial?

In Saudi Arabia, there is no independent law of evidence, though more weight tends to be given to documentary and independent evidence. There is no prohibition on the parties to an infringement action to change their arguments in the course of the trial.

1.6 How long does the trial generally last and how long is it before a judgment is made available?

The Committee for Reviewing Patent Disputes is composed of three lawyers and two technical experts nominated by the President of KACST under Article 35 of the Law of Patents, Layout-Designs of Integrated Circuits, Plants Varieties and Industrial Models.Decisions of the Committee are taken by a majority vote; the grounds for the decision have to be stated in writing. The Committee shall notify KACST of its decisions. The first instance trial before the

1 Patent Enforcement

1.1 Before what tribunals can a patent be enforced against an infringer? Is there a choice between tribunals and what would influence a claimant’s choice?

Under the Saudi national patent system, a patent infringement action is initiated by submitting a statement of claim before a special quasi-judicial committee, “The Committee for Reviewing Patent Disputes”, established for this purpose by nominations from King Abdul-Aziz City for Science & Technology (KACST) pursuant to Article 35 of the Law of Patents, Layout-Designs of Integrated Circuits, Plant Varieties and Industrial Models. The claimant does not have a choice between tribunals. The decisions of the Committee for Reviewing Patent Disputes are subject to appeal before the Administrative Court in Riyadh, and its judgments are also subject to appeal before the Administrative Court of Appeal. The judgments of the Administrative Court of Appeal are final unless the judgment:(a) violates Islamic principles or any codified regulations or

is based on incorrect application or interpretation of the same, including the judicial precedents established by the Administrative Supreme Court;

(b) is issued by a non-competent court; (c) is issued by a court not duly formed according to the law; (d) is based on incorrect characterisation or description of facts;

or(e) contradicts a previous judgment between the same parties.If any of the above causes exist, the judgment of the Administrative Court of Appeal will be subject to a further stage of cassation before the Administrative Supreme Court.

1.2 What has to be done to commence proceedings, what court fees have to be paid and how long does it generally take for proceedings to reach trial from commencement?

Adjudication before the Committee for Reviewing Patent Disputes is free. There are no pre-trial procedural stages. The interested party has to directly file its statement of claim before the Committee. The Committee will send the statement of claim to the defendant in order to submit its reply within a specific period determined by Committee and can be extended upon reasonable request from the defendant. There are no hearings unless the Committee decides otherwise. The Committee usually takes 16 to 24 months to issue a decision.

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Mohammad Jomoa

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1.12 Can a party be liable for infringement of a process patent by importing the product when the process is carried on outside the jurisdiction?

Yes, it can. Importation of infringing products would be an infringement of the patent in Saudi Arabia irrespective of the place of manufacture.

1.13 Does the scope of protection of a patent claim extend to non-literal equivalents?

There is no case law which supports the doctrine of equivalents. Case law to date has dealt with literal infringements.

1.14 Can a defence of patent invalidity be raised, and if so, how? Are there restrictions on such a defence e.g. where there is a pending opposition?

In practice, defence of patent invalidity is allowed in Saudi Arabia. The defendant should raise such defence during an earlier stage of infringement proceedings. The Patent Committee has jurisdiction to decide the invalidity issue. Therefore, in response to patent infringement proceedings, it is recommended for the defendant to initiate a counterclaim or an independent invalidation action.

1.15 Other than lack of novelty and inventive step, what are the grounds for invalidity of a patent?

Apart from the lack of novelty and inventive step, a patent may be invalidated on the following grounds:(a) The invention is not industrially applicable.(b) The subject matter of a patent is hit by exclusionary subject

matters; i.e., the subject matter is not an invention. (c) Commercial exploitation of the invention violates Islamic

principles.(d) Commercial exploitation is harmful to life, to human, animal

or plant health, or is substantially harmful to the environment.(e) Lack of enablement and/or insufficiency of description.

1.16 Are infringement proceedings stayed pending resolution of validity in another court or the Patent Office?

The invalidity and infringement actions both fall within the jurisdiction of the Committee for Reviewing Patent Disputes, and separate invalidity proceedings may be initiated simultaneously with existing infringement proceedings. The infringer may request the Committee to review and decide jointly on the two actions or to stay the infringement action until it decides on the patent invalidity action.

1.17 What other grounds of defence can be raised in addition to non-infringement or invalidity?

The other grounds of defence against an infringement allegation are:(a) In case the subject matter of protection is a process, to allege

that the products are produced using a process different from the protected process.

(b) The illegality of the subject matter of protection in light of Islamic principles, the codified regulations and the established judicial precedents.

Committee takes approximately 16 to 24 months until the decision is issued. The time depends on the workload before the Committee and the existence of the Committee itself, as it is formed every three years by a resolution of the Council of Ministers.

1.7 Are judgments made available to the public? If not as a matter of course, can third parties request copies of the judgment?

According to Article 168 of the Saudi Civil Procedures Law, only the party in whose favour the judgment is issued is entitled to request and receive an executable copy of the judgment. In case that the judgment is issued in favour of more than a party, each party will be provided with an executable copy of the judgment. If the judgment is intended to be executed outside Saudi Arabia, the applicable treaties and covenants will be recognised as regards the number of copies of judgment and the persons entitled to request such copies.Third parties cannot request copies of the judgment. However, the Ministry of Justice selects and publishes some of the final judgments in periodical journals without mentioning the names of parties to the case. The purpose of publication is educational and recordation of recognised precedents.

1.8 Are there specialist judges or hearing officers, and if so, do they have a technical background?

The Committee is composed of three lawyers and two technical experts nominated by the President of KACST.In addition, the Committee may seek the assistance of different expert bodies with respect to the technical matters of the dispute.

1.9 What interest must a party have to bring (i) infringement, (ii) revocation, and (iii) declaratory proceedings?

The party initiating an infringement action should establish its personal interest in the action by proving its ownership of a valid and effective document of protection, or its rights of exploitation of the subject matter of protection, under a duly recorded licence. In a revocation action, the plaintiff is not required to prove an actual personal interest in the action, because any person having a constructive interest is entitled to file an invalidation action in case the patent in issue violates any of the legal requirements. Declaratory proceedings are not recognised in Saudi Arabia.

1.10 If declarations are available, can they address (i) non-infringement, and/or (ii) claim coverage over a technical standard or hypothetical activity?

Declaration proceedings are not available in Saudi Arabia. The Committee for Reviewing Patent Disputes or appellate court will adjudicate the issue of dispute upon submission of an infringement claim against the defendant.

1.11 Can a party be liable for infringement as a secondary (as opposed to primary) infringer? Can a party infringe by supplying part of, but not all of, the infringing product or process?

Contributory infringement is not recognised. Nevertheless, nothing prohibits a patent owner from suing infringers jointly in an infringement action, in case their collective efforts resulted in the infringement of its patented rights.

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1.22 How common is settlement of infringement proceedings prior to trial?

The parties to a dispute can make a settlement before the trial of infringement proceedings and at any time during infringement proceedings. The settlement has to be submitted in the form of a written agreement to the Committee for Reviewing Patent Disputes in case that the agreement is concluded during the trial. The Committee will review the agreement and issue a decision without adjudicating issues in dispute.

1.23 After what period is a claim for patent infringement time-barred?

Claims for patent infringement can be enforced after the patent is granted. There is no time-bar for a claim for patent infringement.

1.24 Is there a right of appeal from a first instance judgment, and if so, is it a right to contest all aspects of the judgment?

Yes, the first instance judgment issued by the Committee for Reviewing Patent Disputes is subject to appeal before the Administrative Court in Riyadh, and its judgments are also subject to appeal before the Administrative Court of Appeal. The judgments of the Administrative Court of Appeal are final unless the judgment:(a) violates Islamic principles or any codified regulations or

is based on incorrect application or interpretation of the same, including judicial precedents established by the Administrative Supreme Court;

(b) is issued by a non-competent court;(c) is issued by a court not duly formed according to the law; (d) is based on incorrect characterisation or description of facts;

or(e) contradicts a previous judgment between the same parties.If any of the above causes exist, the judgment of the Administrative Court of Appeal will be subject to a further stage of cassation before the Administrative Supreme Court.

1.25 What are the typical costs of proceedings to first instance judgment on (i) infringement and (ii) validity; how much of such costs are recoverable from the losing party?

Litigants usually pay the legal and professional costs. There are no official adjudication costs. Costs awards are generally subject to the discretion of the Committee.

1.26 For jurisdictions within the European Union: What steps are being taken in your jurisdiction towards ratifying the Agreement on a Unified Patent Court, implementing the Unitary Patent Regulation (EU Regulation No. 1257/2012) and preparing for the unitary patent package? For jurisdictions outside of the European Union: Are there any mutual recognition of judgments arrangements relating to patents, whether formal or informal, that apply in your jurisdiction?

The Enforcement Law provides that foreign judgments may be enforced on the basis of reciprocity if the following conditions are present:(1) The Saudi courts are not competent to consider the dispute,

and the foreign court is competent in accordance with its own rules.

(c) The unsafe exploitation of the subject matter of protection in light of its impact on human or animal health and the environment.

1.18 Are (i) preliminary, and (ii) final injunctions available, and if so, on what basis in each case? Is there a requirement for a bond?

Only preliminary injunction is available in Saudi Arabia, in theory. It is based on the following conditions:(a) There must be an infringement action already filed before the

Committee, and in the absence of such action, the applicant has to file, within 10 days of the date of injunction application, an infringement action before the Committee.

(b) Submitting a surety or guarantee bond as requested by the Committee.

(c) Prima facie evidence that the original infringement action is likely to be decided in favour of the applicant.

The law authorises the Committee for Reviewing Patent Disputes to issue preliminary injunctions; however, preliminary injunctions are rarely awarded. Request for an injunction can be filed along with prima facie evidence of a claimant’s registered patent rights and an infringing act by the defendant. A surety or guarantee bond is required.

1.19 On what basis are damages or an account of profits assessed?

Although it is theoretically possible for the aggrieved party to claim damages, the Saudi courts are generally reluctant in this regard. In order for a claim of damages to be acceptable in Saudi Arabia, the relevant damage must be proved to be direct, actual and countable. Indirect damage, loss of profit, or damage likely to occur, are not acceptable according to Islamic principles. Damages awards are very rare in practice. Under Islamic law, the strict evidentiary requirement – in particular, the cause and effect relationship between infringement and damages – makes it difficult to prove actual damage as per standards of Islamic law. It is very unlikely that damages or account of profit will be awarded in Saudi Arabia.

1.20 How are orders of the court enforced (whether they be for an injunction, an award of damages or for any other relief)?

A law of Execution issued under Royal Decree No. M/53 is in force. This law applies only to the judgments issued by commercial courts. According to this law, the Court of Execution is entitled to enforce the judgment against the judgment-debtor even by force.Criminal and administrative judgments are exempted from the scope of jurisdiction of the Court of Execution, and they are enforceable through the governor.

1.21 What other form of relief can be obtained for patent infringement? Would the tribunal consider granting cross-border relief?

Other possible forms of relief for patent infringement are:(a) confiscation and destruction of infringing products;(b) confiscation and destruction of all material and tools used by

the infringer in producing the infringing products; or(c) prohibition of importation of infringing products. It is very unlikely that the Saudi tribunal would grant cross-border relief.

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for the patentee. However, such type of compulsory licence is not common.An application for a compulsory licence is filed with the King Abdulaziz City for Science and Technology. It has jurisdiction to grant, amend, reject or cancel a compulsory licence.

4 Patent Term Extension

4.1 Can the term of a patent be extended, and if so, (i) on what grounds, and (ii) for how long?

The term of a patent is 20 years commencing as of the date of filing the patent application. Patent terms cannot be extended, and there are no provisions on patent term extensions or supplementary protection certificates.

5 Patent Prosecution and Opposition

5.1 Are all types of subject matter patentable, and if not, what types are excluded?

The following subject matter is excluded from patent protection:(a) discoveries, scientific theories and mathematical methods;(b) schemes, rules and methods of conducting commercial

activities, exercising pure mental activities or playing a game;

(c) plant, animals and processes – which are mostly biological – used for the production of plants or animals, with the exception of micro-organisms, non-biological and microbiological processes; and

(d) methods of surgical or therapeutic treatment of the human or animal body and methods of diagnosis applied to human or animal bodies, with the exception of products used in any of these methods.

In addition, patent protection will not be granted if the commercial exploitation of the invention contradicts the Shari’ah law or is harmful to life, human, animal or public health or is substantially harmful to the environment.

5.2 Is there a duty to the Patent Office to disclose prejudicial prior disclosures or documents? If so, what are the consequences of failure to comply with the duty?

If the invention has been previously disclosed, the documents showing the date of disclosure and the reasons for the disclosure shall be provided to the Patent Office. The Patent Office is under legal duty to disclose, upon demand from the Committee for Reviewing Patent Disputes, any document it has relating to the patent in issue.

5.3 May the grant of a patent by the Patent Office be opposed by a third party, and if so, when can this be done?

The grant of a patent may be opposed by any interested party, and partial and total revocation may be sought provided that the provisions for grant of a patent have been violated. The opposition shall be filed with the Committee for Reviewing Patent Disputes within 90 days as of the date of publishing the decision of grant in the Official Gazette.

(2) The parties to the dispute have been summoned and represented.

(3) The judgment does not contradict a judgment or order on the same subject issued by a competent judicial authority in Saudi Arabia.

(4) The judgment does not violate or contradict Shari’ah law.Furthermore, Saudi Arabia is a party to the Riyadh Arab Agreement for Judicial Cooperation, which provides for recognition and enforcement of judgments of the courts of the member states. There are presently 16 member states, including the UAE.

2 Patent Amendment

2.1 Can a patent be amended ex parte after grant, and if so, how?

No, a patent cannot be amended ex parte after being granted.

2.2 Can a patent be amended in inter partes revocation/invalidity proceedings?

No, once a protection document is issued it will not be amended unless the amendment relates to the ownership of the protection document.

2.3 Are there any constraints upon the amendments that may be made?

No amendment is allowed after issuance of the protection document.

3 Licensing

3.1 Are there any laws which limit the terms upon which parties may agree a patent licence?

The parties have freedom to agree the terms of the licence agreement. The licences may relate to all or some of the acts of exploitation of the patent and shall not exceed the period of protection. The licence should be recorded with the Patent Office. It shall not deprive the owner from exploiting the invention or granting another licence. The licensee cannot assign the rights licensed to him unless otherwise stated in the licence agreement.The Patent Office has discretionary power to instruct the parties to amend the licence in order to prevent abuse of the patent rights, negative effect on competition, or acquisition of technology and its dissemination.

3.2 Can a patent be the subject of a compulsory licence, and if so, how are the terms settled and how common is this type of licence?

Yes, a patent can be the subject of a compulsory licence after four years from the date of filing of the application, or three years from the grant of the patent (whichever expires later), provided that the patent has not been exploited or its exploitation has not met the public interest with no legitimate reason. The prospective licensee must have made reasonable efforts to secure a licence on reasonable commercial terms and financial compensation.Compulsory licences shall not be exclusive and are granted to make the invention available in the local market against fair compensation

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The GCC Customs law “prohibits admission, transit or exit of prohibited or infringing goods…”. Goods that violate intellectual property rights are considered “prohibited goods”.Therefore, in theory, patent infringements may be stopped at the border, both imported and exported. However, in practice, there is no ex officio action available (this is restricted to trade mark infringements and certain types of copyright infringements at this time), and in order to prevent importation of a patent infringement, a court order would be required.

7 Antitrust Law and Inequitable Conduct

7.1 Can antitrust law be deployed to prevent relief for patent infringement being granted?

The Saudi law of competition is new and, in its current scope, does not include any provision which may affect the grant of relief for patent infringement.

7.2 What limitations are put on patent licensing due to antitrust law?

No specific limitations exist.

8 Current Developments

8.1 What have been the significant developments in relation to patents in the last year?

On 3 August 2013, Saudi Arabia acceded to the Patent Cooperation Treaty (PCT). Therefore, any international patent applications filed on or after this date can designate Saudi Arabia. The priority period for a national phase entry is 30 months from the earliest priority date. Recently, patent regulations were amended, and restoration procedure was adopted.

8.2 Are there any significant developments expected in the next year?

There is a proposal to amend the Saudi Law of Patents, Layout-Designs of Integrated Circuits, Plant Varieties and Industrial Models:(a) The draft law proposes to abolish the Patent Dispute

Committee. (b) Provisions related to compulsory licence may be amended.(c) Jurisdiction to hear invalidity proceedings may be changed.(d) An amendment may also introduce utility model protection in

Saudi Arabia.Discussions with respect to the accession of the GCC Patent Office (located in Saudi Arabia) to the PCT are ongoing. At this stage, however, there are no clear indications as to when the GCC Patent Office would become a PCT member. All GCC states are now members of PCT. The GCC Patent Office allows for the granting of a regional patent that is automatically valid in the six member states. If the GCC Patent Office becomes party to the PCT, it is likely that some applicants may prefer to obtain a regional patent rather than individual national patents.

5.4 Is there a right of appeal from a decision of the Patent Office, and if so, to whom?

The decision of the Saudi Patent Office is subject to appeal before the Committee for Reviewing Patent Disputes. The decisions of the Committee are subject to appeal before the Administrative Court in Riyadh, and its judgments are also subject to appeal before the Administrative Court of Appeal. The judgments of the Administrative Court of Appeal are final unless the judgment:(a) violates Islamic principles or any codified regulations or

is based on incorrect application or interpretation of the same, including the judicial precedents established by the Administrative Supreme Court;

(b) is issued by a non-competent court;(c) is issued by a court not duly formed according to the law;(d) is based on incorrect characterisation or description of facts;

or(e) contradicts a previous judgment between the same parties.If any of the above causes exist, the judgment of the Administrative Court of Appeal will be subject to a further stage of cassation before the Administrative Supreme Court.

5.5 How are disputes over entitlement to priority and ownership of the invention resolved?

Disputes over entitlement to priority and ownership of the invention are resolved by the Committee for Reviewing Patent Disputes. The interested party has to initiate the action before the Committee within five years from the date of grant of the patent subject of dispute; otherwise, it will lose its right of adjudication in this regard.A patent is a personal right of the person who created the invention and may be transferred by inheritance. If two or more people participated in the creation of the invention, they shall have equal rights to the invention. The first-to-file approach is used to resolve disputes with regard to priority, where two or more people have created the same invention.With respect to inventions created during the course of employment, the employer shall own the invention, unless otherwise provided in the employment contract. Any patent filed in the period two years after the employment has been terminated shall belong to the employer.

5.6 Is there a “grace period” in your country, and if so, how long is it?

No, there is no “grace period”.

5.7 What is the term of a patent?

The term of a patent is 20 years from date of filing or deemed date of filing or the international filing date.

6 Border Control Measures

6.1 Is there any mechanism for seizing or preventing the importation of infringing products, and if so, how quickly are such measures resolved?

The GCC Customs Law provides a unified law relating to customs matters in the six GCC countries – Bahrain, Kuwait, Qatar, Oman, Saudi Arabia and the United Arab Emirates.

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8.3 Are there any general practice or enforcement trends that have become apparent in your jurisdiction over the last year or so?

Of the six GCC member states, Saudi Arabia appears to have the highest established standards with regard to patent protection. The decisions of the Committee are published in the Official Gazette, which is not yet the practice in the other GCC members.

Rouse & Co. International/Kadasa & Partners Saudi Arabia

Sara HolderRouse & Co. International11th Floor, The Maze TowerSheikh Zayed Road, PO Box 31778DubaiUnited Arab Emirates

Tel: +971 4 309 8000Fax: +971 4 309 8001Email: [email protected]: www.rouse.com

Mohammad JomoaKadasa & PartnersKadasa Building, Ibn Katheer StreetKing Abdulaziz Street, PO Box 20883 Riyadh 11465Saudi Arabia

Tel: +966 11 478 6315Fax: +966 11 476 1044Email: [email protected]: www.kadasa.com.sa

KADASA & PARTNERS was founded almost 40 years ago by the renowned Saudi attorney Nassir Ali Kadasa in Riyadh, the Saudi capital, under Associated Patent Attorneys (APA). Mr. Kadasa has the distinction of being the first Saudi Attorney to prosecute and win an infringement lawsuit on behalf of a foreign entity against a national infringer.

The mainstay of our firm is our qualified and experienced 50+ staff members. Our staff has skilfully navigated through all IP matters in Saudi Arabia and the Middle East.

Kadasa & Partners embraces a tradition of providing quality service and filing through registration or grant of trademarks, patents, and copyright. Also, it provides maintenance and protection services for all forms of intellectual property rights. IP rights protection and enforcement is the major area of our strength and constitutes a sizeable part of our practice. Technology Transfer Agreements and other IP-related matters are also provided to our clients by our specialised team of attorneys and specialised experts affiliated with the office. As unfair competition, particularly counterfeiting, passing off, and other deceptive practices, have become so pervasive in the Saudi Kingdom in the last decade, our office has developed an investigation and market-watch service and composed a capable team of attorneys for preparing and following up complaints and lawsuits against counterfeiters with the Ministry of Commerce and the Board of Grievances (the Saudi Circuit Court) and has successfully managed to cause the seizure, confiscation, and destruction of huge quantities of counterfeit products in Saudi Arabia.

In Saudi Arabia, Kadasa & Partners operates in association with international IP law firm, Rouse & Co. International. Established in 1990, Rouse is an intellectual property (IP) law firm and consultancy, with offices in 13 countries. We provide the full range of IP services required by our clients to develop, implement and continually revise an IP strategy, from the implementation of global enforcement strategies to the provision of commercial IP services, and IP acquisition and maintenance services. We currently represent approximately 1,400 clients managing work in over 180 countries. Long-standing clients include many of the world’s foremost IP owners.

Sara Holder currently heads up the MEA practice of global IP firm, Rouse. She holds degrees in law and science (Biochemistry) and qualified and practised in New Zealand as a lawyer before joining Rouse in 1998. Since then, she has worked in China, Indonesia and the Middle East, becoming a specialist in the issues and challenges faced by, and encountered in, developing intellectual property jurisdictions.

In addition to her academic qualifications and experience, Sara is a member of various IP organisations, has published numerous articles in industry journals, contributed to various texts on intellectual property and speaks regularly at seminars and conferences. She is regularly ranked as a leader in her field.

Mohammad Jomoa is the Intellectual Property Manager at Kadasa & Partners, specialising in pharmaceutical and petrochemical patent litigation.

He holds a Postgraduate Diploma in Intellectual Property Laws (FPLC (USA) and International Law Institute (Gulf)), and a Bachelor of Science in Chemical Engineering (University of Toledo, Ohio, USA). Mohammad has over 28 years of experience in IP matters in Saudi Arabia and in the Gulf Cooperation Council (GCC) states. He has supervised advanced and graduate studies programmes in IP in cooperation with international organisations and renowned universities. Expertise includes Patent and designs prosecution, litigation, and freedom to operate opinions under GCC and Saudi Patent Law. As an external counsel for many Pharma companies, he extensively worked on Data Protection, Patent Linkage and Pharmaceutical laws. Mr. Jomoa is a regular speaker on IP issues in the gulf region, He advises Kadasa clients on techno-legal issues in the Middle East region and regularly advises Saudi Government offices on IP legislation.

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Chapter 23

De Beer Attorneys

South Africa

particulars, the defendant must deliver to the plaintiff a notice of intention to defend.

■ Within 20 court days after the delivery of the defendant’s notice of intention to defend, the defendant must deliver a plea with or without a counterclaim. In his plea, the defendant must set out his defences and may, for example, raise non-infringement or invalidity as a defence. The patent legislation also provides for a counterclaim for the revocation of the patent.

■ Within 15 court days after the delivery of the defendant’s plea and/or counterclaim, the plaintiff must deliver a replication to the defendant’s plea and/or a plea to the defendant’s counterclaim.

■ Within 10 court days after the delivery of the plaintiff’s replication and/or plea, the defendant may deliver a replication in reconvention.

Further pleadings by the parties, if any, must be delivered within 10 court days after delivery of the previous pleading by the opposite party. A party who fails to deliver a replication or subsequent pleading within the time specified above will be barred. Once the pleadings are closed, any party to the proceedings may require the other party to make discovery of documents and any other relevant material relating to any matter in the proceedings within 20 court days. Other possible interlocutory proceedings include inspection and production of documents. A pre-trial conference may follow thereafter, which serves a purpose of ironing out any issues relating to the action and the upcoming trial, and which is held before a judge who must, however, not be involved in settlement negotiations between the parties. It is permissible to lead expert evidence in the trial and expert witnesses are examined viva voce.

1.5 How are arguments and evidence presented at the trial? Can a party change its pleaded arguments before and/or at trial?

The trial includes opening arguments, examination of witnesses and presentation of evidence, closing arguments and the handing down of judgment. The witnesses provide oral evidence and are examined in chief, cross-examined and then re-examined. After all the evidence has been led, both parties address the court with their closing arguments on the pleadings and evidence. Pleadings can be amended any time before the trial by the parties.

1.6 How long does the trial generally last and how long is it before a judgment is made available?

The length of the trial depends on the complexity of the matter; therefore, the more complicated the matter, the longer the trial.

1 Patent Enforcement

1.1 Before what tribunals can a patent be enforced against an infringer? Is there a choice between tribunals and what would influence a claimant’s choice?

In South Africa, there are no tribunals before which a patent can be enforced against an infringer except the Court of the Commissioner of Patents. An infringement action can be instituted in this Court and the Commissioner, who is a judge of a division of the High Court of South Africa, presides over such and other action proceedings. The Court of the Commissioner of Patents has the status of a division of the High Court and is the only court that has jurisdiction over a patent matter in the first instance. A claimant therefore has no choice in the matter.

1.2 What has to be done to commence proceedings, what court fees have to be paid and how long does it generally take for proceedings to reach trial from commencement?

Proceedings are commenced on a combined summons accompanied by Particulars of Claim, which documents are issued by the Registrar of the Court of the Commissioner of Patents. Service of the documents is conducted by the sheriff or his deputy at a fee, in the area where the defendant is located. The length of the proceedings from commencement varies and is dependent on the level of co-operation of the parties to the proceedings.

1.3 Can a party be compelled to disclose relevant documents or materials to its adversary either before or after commencing proceedings, and if so, how?

The only time that a party will be compelled to disclose relevant documents or any material is during the discovery stage of the proceedings after the commencement thereof. A party may apply to the Commissioner to order the other party who refuses to make discovery to comply with the rules, failing which, the Commissioner may dismiss the claim or strike out the defence of the party in default.

1.4 What are the steps each party must take pre-trial? Is any technical evidence produced, and if so, how?

The procedure pre-trial is as follows:■ Within 10 court days from the date of service on the defendant

of the combined summons, which includes a statement of

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1.11 Can a party be liable for infringement as a secondary (as opposed to primary) infringer? Can a party infringe by supplying part of, but not all of, the infringing product or process?

Contributory infringement is a form of a delict and is not specifically recognised in the Patents Act. Therefore, in order to prove contributory infringement, a patentee must show that the requirements for a delict such as unlawfulness and fault (intention) are present. According to case law, acts which include procuring, inducing, aiding and abetting may constitute contributory infringement. A party can thus be held liable for indirect infringement of a patent.

1.12 Can a party be liable for infringement of a process patent by importing the product when the process is carried on outside the jurisdiction?

The Patents Act provides that a claim to a process extends to a product produced by that process. Thus, the importation of such product would constitute infringement.

1.13 Does the scope of protection of a patent claim extend to non-literal equivalents?

Although it is the patent claims alone that define the monopoly, South African courts have held that the claims must be interpreted in the light of the whole patent specification and not in isolation. This has led to the development of what is referred to as the contextual approach.

1.14 Can a defence of patent invalidity be raised, and if so, how? Are there restrictions on such a defence e.g. where there is a pending opposition?

A defence of invalidity can take two forms, viz, a counterclaim for the revocation of a patent or a defence that would not necessarily result in patent revocation.

1.15 Other than lack of novelty and inventive step, what are the grounds for invalidity of a patent?

Section 61(1) of the Patents Act provides an exhaustive list of the grounds on which a patent may be revoked. The grounds are as follows:■ that the patentee is not a person entitled under Section 27 to

apply for the patent. In terms of Section 27, only the inventor or a person acquiring from him the right to apply, or both the inventor and such other person, may apply for a patent;

■ that the grant of the patent is in fraud of the rights of the applicant or any person under or through whom he claims;

■ that the invention concerned is not patentable under Section 25. Other than the lack of novelty and inventive step, Section 25 provides that a patent shall not be granted for an invention which is not capable of being used in trade, industry or agriculture, an invention the publication or exploitation of which would be generally expected to encourage offensive or immoral behaviour, any variety of animal or plant or an essentially biological process for the production of animals or plants, not being a microbiological process or the product of such a process, and an invention of a method of treatment of the human or animal body by surgery or therapy or of diagnosis practised on the human or animal body;

Usually a trial involving a more complicated matter lasts for about four weeks, whereas a trial involving a less complicated matter could take only one week.

1.7 Are judgments made available to the public? If not as a matter of course, can third parties request copies of the judgment?

Judgments handed down by the Court of the Commissioner of Patents are published in print and in electronic form, and are therefore available to the public.

1.8 Are there specialist judges or hearing officers, and if so, do they have a technical background?

A judge of a division of the High Court (the Commissioner) presides over patent matters and is therefore unlikely to have a technical background.

1.9 What interest must a party have to bring (i) infringement, (ii) revocation, and (iii) declaratory proceedings?

(i) Infringement proceedings are instituted by the patentee and/or joint patentee. A joint patentee may give notice to other patentees to join the action as co-plaintiffs. In the case where there is a normal licence, a patentee must give notice to every licensee recorded as such in the register who can intervene as co-plaintiff in the proceedings. A licensee under a licence granted by virtue of an endorsement of a patent may call upon the patentee to undertake proceedings, and if the patentee does not institute the proceedings within two months therefrom, the licensee may do so in his own name.

(ii) Any person may apply at any time for the revocation of a patent.

(iii) There are two types of declaratory proceedings; namely, declaration of non-infringement and declaration of infringement. Any person may apply to the Commissioner of Patents for a declaration that the use of any process or the making, using, disposing of or offering to dispose of, or importing any article does not or would not constitute an act of infringement of a patent. A patentee, on the other hand, may institute proceedings for a declaration that the patent was infringed.

1.10 If declarations are available, can they address (i) non-infringement, and/or (ii) claim coverage over a technical standard or hypothetical activity?

(i) As mentioned in question 1.9 (iii) above, any person may apply for a declaration of non-infringement and in so doing, it is provided in the patent legislation that the person must prove firstly that they applied in writing to the patentee for a written acknowledgment to the effect of the declaration claimed and have furnished the patentee with full particulars of the process or article in question, and secondly that the patentee has failed to give such an acknowledgment.

(ii) The declaration can address claim coverage over a technical standard and it is doubtful that it would address hypothetical activity.

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1.18 Are (i) preliminary, and (ii) final injunctions available, and if so, on what basis in each case? Is there a requirement for a bond?

Preliminary and final injunctions are available and there are requirements that need to be met before a court grants same. In the case of a preliminary injunction, an applicant must show the following:(i) a prima facie right;(ii) a reasonable apprehension of irreparable harm if the

preliminary injunction is not granted;(iii) there is no alternative satisfactory remedy available to the

applicant; and(iv) the balance of convenience is in favour of the granting of

the preliminary relief.In the case of a final injunction, an applicant must show the following:(i) there is a clear right;(ii) there is an actual injury committed or a reasonable

apprehension thereof;(iii) there is no alternative satisfactory remedy available to the

applicant.There is no requirement for a bond but a security for the costs of the injunction may be required.

1.19 On what basis are damages or an account of profits assessed?

Damages are calculated as loss of profits. Punitive damages are not known in South Africa. It is not a requirement in South Africa that the plaintiff prove the actual damages suffered, and in lieu of damages a court may award a reasonable royalty. In both cases, the plaintiff must pray for an order that an enquiry be held as to the actual amount of damages suffered and what a reasonable royalty would be.

1.20 How are orders of the court enforced (whether they be for an injunction, an award of damages or for any other relief)?

The Sheriff is usually involved in the enforcement of court orders and any refusal by party to comply with the order may result in the party being liable for contempt of court. With regard to damages, the parties may decide to enter into a settlement agreement after they have obtained a determination of the amount of damages suffered.

1.21 What other form of relief can be obtained for patent infringement? Would the tribunal consider granting cross-border relief?

Apart from damages and an injunction, a plaintiff in an infringement action can claim the delivery of any infringing product or any article or product which forms an inseparable part thereof and the costs of suit, including the costs of Counsel. Cross-border relief is not provided for.

1.22 How common is settlement of infringement proceedings prior to trial?

There are more infringement cases that are settled out of court than there are cases that proceed to trial, most commonly due to the high cost of litigation.

■ that the invention as illustrated or exemplified in the complete specification concerned cannot be performed or does not lead to results and advantages set out in the complete specification;

■ that the complete specification concerned does not sufficiently describe, ascertain and, where necessary, illustrate or exemplify the invention and the manner in which it is to be performed in order to enable the invention to be carried out by a person skilled in the art of such invention;

■ that the claims of the complete specification concerned are not clear or fairly based on the matter disclosed in the specification;

■ that the prescribed declaration lodged in respect of the application for the patent or the statement lodged in terms of Section 30(3A) contains a false statement or representation which is material and which the patentee knew or ought reasonably to have known to be false at the time when the statement or representation was made. In terms of Section 30(3A), an applicant must state whether the invention for which protection is claimed is based on or derived from an indigenous biological resource, genetic resource, or traditional knowledge or use;

■ that the application for the patent should have been refused in terms of Section 36. According to this section, the registrar of patents shall refuse an application which appears to be frivolous and would be expected to encourage offensive or immoral behaviour, and which might be used in any manner contrary to law (unless the specification is amended); and

■ that the complete specification claims as an invention a microbiological process or product thereof and that the provisions of Section 32(6) have not been complied with. Section 32(6) relates to how micro-organisms should be dealt with.

1.16 Are infringement proceedings stayed pending resolution of validity in another court or the Patent Office?

In terms of Section 51(9) of the Patents Act, where any proceedings relating to a patent (including infringement proceedings) are pending in any court, an application for the amendment of the relevant specification shall be made to that court, which may deal with such application for amendment as it thinks fit, or may stay such pending proceedings and remit such application for amendment to the registrar. What this section means is that a court may stay the infringement proceedings involving a counterclaim for revocation of a patent in order for the patentee to effect amendments.

1.17 What other grounds of defence can be raised in addition to non-infringement or invalidity?

Defences to infringement are not listed in the Patents Act; however, in addition to non-infringement and invalidity, the Gillette defence, exhaustion of rights, leave and licence, and acquiescence, election, waiver and estoppel have been recognised as defences to infringement. Briefly, the Gillette defence comes from a decision from the House of Lords in the UK relating to a patent for a safety razor. It was held: If the claims of such a patent were so wide as to include it

[safety razor], the patent would be bad, because it would include something which differed by no patentable difference from that which was already in possession of the public. Such a patent would be bad for want of novelty. If the claims were not sufficiently wide to include the defendant’s razor, the patentee could not complain of the public making it. In other words, the defendants must succeed either on invalidity or on non-infringement.

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■ the specification as amended would include any claim not fairly based on matter disclosed in the specification before amendment; and

■ the specification as amended would include any claim not wholly within the scope of a claim included in the specification before amendment.

2.2 Can a patent be amended in inter partes revocation/invalidity proceedings?

A patent can, at the discretion of the Commissioner, be amended during revocation or invalidity proceedings.

2.3 Are there any constraints upon the amendments that may be made?

See question 2.1 above.

3 Licensing

3.1 Are there any laws which limit the terms upon which parties may agree a patent licence?

Section 90(1) of the Patents Act provides that any condition in a contract relating to a licence under a patent of which the effect will be:■ to prohibit or restrict the purchaser or licensee from

purchasing or using any article or class of articles, whether patented or not, supplied or owned by any person other than the seller or licensor or his nominee;

■ to prohibit or restrict the licensee from using any article or process not protected by the patent;

■ to require the purchaser or licensee to acquire from the seller, licensor or his nominee any article or class of articles not protected by the patent;

■ to require or induce the purchaser to observe a specified minimum resale price in respect of any article or class of articles protected by the patent; or

■ to prohibit or restrict the making, using, exercising or disposing of the invention concerned in any country in which the invention is not patented,

shall be null and void.It is further provided that nothing in Section 90(1) above shall:■ affect any condition in a contract whereby a person is

prohibited from selling any goods other than those of a particular person; or

■ affect any condition in a contract for the lease of or a licence to use a patented article, whereby the lessor or licensor reserves to himself or his nominee the right to supply such new parts of the patented article, other than ordinary articles of commerce, as may be required to put or keep it in repair.

3.2 Can a patent be the subject of a compulsory licence, and if so, how are the terms settled and how common is this type of licence?

A compulsory licence may be granted in respect of a dependent patent where its working without infringing a prior patent would depend upon the obtainment of a licence under that prior patent. In addition, a compulsory licence may be granted if any interested person can prove that the rights in a patent are being abused by the following reasons:

1.23 After what period is a claim for patent infringement time-barred?

A claim for damages should be made within three years from the date of infringement, after which the claimant may be barred from claiming such damages provided that there are no acts of infringement which fall within that period.

1.24 Is there a right of appeal from a first instance judgment, and if so, is it a right to contest all aspects of the judgment?

It is possible to apply for leave to appeal a judgment made by the Court of the Commissioner of Patents to a full bench of the High Court or to the Supreme Court of Appeals. If such leave to appeal is refused, a party may apply directly to the Supreme Court of Appeal for such leave. It is also possible to apply to the Constitutional Court if hearing of the matter would be in the public interest. This is not common in patent matters. Decisions, however, relating to preliminary injunctions cannot be appealed.

1.25 What are the typical costs of proceedings to first instance judgment on (i) infringement, and (ii) validity? How much of such costs are recoverable from the losing party?

There are various factors that may be at play in patent infringement actions, thus making it nearly impossible to quantify the costs involved. Generally, the more complex the matter, the higher the costs. Thus, put differently, costs are directly proportional to the complexity of a matter. Appeals, on the other hand, cost less than the costs involved in a trial. The courts have discretion in the awarding of party-and-party costs, attorney-and-client costs, and punitive costs. In the case of the latter, payment of the full costs of the other party may be ordered.

1.26 For jurisdictions within the European Union: What steps are being taken in your jurisdiction towards ratifying the Agreement on a Unified Patent Court, implementing the Unitary Patent Regulation (EU Regulation No. 1257/2012) and preparing for the unitary patent package? For jurisdictions outside of the European Union: Are there any mutual recognition of judgments arrangements relating to patents, whether formal or informal, that apply in your jurisdiction?

South Africa is not within the European Union and does not have formal recognition of judgment arrangements relating to patents. Having said that, however, our courts usually look at the decisions of the English courts for guidance when dealing with similar issues.

2 Patent Amendment

2.1 Can a patent be amended ex parte after grant, and if so, how?

A patent can be amended after grant; however, the application for amendment is advertised in the Patent Journal at the direction of the Registrar of Patents and any interested third party may oppose such application within two months from the date of the advertisement. A post-grant amendment shall not be allowed if:■ the effect of such amendment would be to introduce new

matter or matter not in substance disclosed in the specification before amendment;

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5.2 Is there a duty to the Patent Office to disclose prejudicial prior disclosures or documents? If so, what are the consequences of failure to comply with the duty?

There is no duty to disclose prejudicial prior disclosures, since South Africa is a non-examining country.

5.3 May the grant of a patent by the Patent Office be opposed by a third party, and if so, when can this be done?

There is no opposition of grant in South Africa and a patent can only be revoked after grant.

5.4 Is there a right of appeal from a decision of the Patent Office, and if so, to whom?

Appeals to the Commissioner from any decision of the Registrar of Patents are possible.

5.5 How are disputes over entitlement to priority and ownership of the invention resolved?

Disputes are resolved on application to the Court of the Commissioner of Patents.

5.6 Is there a “grace period” in your jurisdiction, and if so, how long is it?

There is no grace period in our jurisdiction.

5.7 What is the term of a patent?

The term of the patent is 20 years.

6 Border Control Measures

6.1 Is there any mechanism for seizing or preventing the importation of infringing products, and if so, how quickly are such measures resolved?

Apart from a preliminary injunction brought on an urgent application, there are no other border control measures available.

7 Antitrust Law and Inequitable Conduct

7.1 Can antitrust law be deployed to prevent relief for patent infringement being granted?

There are no antitrust proceedings in South Africa in respect of patent infringement.

7.2 What limitations are put on patent licensing due to antitrust law?

The South African Competition Act does not provide any guidelines as to what limits are to be placed in respect of patent licensing.

■ the patented invention is not being worked in the Republic on a commercial scale or to an adequate extent, after the expiry of a period of four years subsequent to the date of the application for the patent or three years subsequent to the date on which that patent was sealed, whichever period last expires, and there is in the opinion of the commissioner no satisfactory reason for such non-working;

■ the demand for the patented article in the Republic is not being met to an adequate extent and on reasonable terms;

■ by reason of the refusal of the patentee to grant a licence or licences upon reasonable terms, the trade or industry or agriculture of the Republic or the trade of any person or class of persons trading in the Republic, or the establishment of any new trade or industry in the Republic, is being prejudiced, and it is in the public interest that a licence or licences should be granted; or

■ the demand in the Republic for the patented article is being met by importation and the price charged by the patentee, his licensee or agent for the patented article is excessive in relation to the price charged therefor in countries where the patented article is manufactured by or under licence from the patentee or his predecessor or successor in title.

So far, there has not been any compulsory licence granted in South Africa.

4 Patent Term Extension

4.1 Can the term of a patent be extended, and if so, (i) on what grounds, and (ii) for how long?

In South Africa, the patent term cannot be extended.

5 Patent Prosecution and Opposition

5.1 Are all types of subject matter patentable, and if not, what types are excluded?

Section 25 of the Patents Act states that anything which consists of the following is unpatentable:■ a discovery;■ a scientific theory;■ a mathematical method;■ a literary, dramatic, musical or artistic work or any other

aesthetic creation;■ a scheme, rule or method for performing a mental act, playing

a game or doing business;■ a program for a computer; or■ the presentation of information.Furthermore, a patent shall not be granted for the following:■ an invention the publication or exploitation of which would

be generally expected to encourage offensive or immoral behaviour;

■ any variety of animal or plant or any essentially biological process for the production of animals or plants, not being a micro-biological process or the product of such a process; and

■ an invention of a method of treatment of the human or animal body by surgery or therapy or of diagnosis practised on the human or animal body shall be deemed not to be capable of being used or applied in trade or industry or agriculture.

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8 Current Developments

8.1 What have been the significant developments in relation to patents in the last year?

The South African Department of Trade and Industry (DTI) released and invited public comment on its Intellectual Property Consultative Framework (IPCF). In the preamble of the document, it is stated that the purpose of the IPCF is “to put forward the perspective of the DTI in a consultative instrument to facilitate what will be continuous engagement with governmental partners and society at large”. One of the premises on which it is based is that the envisaged national IP policy should promote public health and it identifies, inter alia, the following as immediate issues:■ substantive search and examination of patents – especially

pharmaceutical patents;■ patentability criteria – to address health concerns; ■ patent disclosure requirements – make use of the Agreement

on Trade-Related Aspects of Intellectual Property Rights (TRIPS);

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■ parallel importation – incorporate into the Patents Act international exhaustion to clarify matters;

■ compulsory licensing – streamline administrative processes; and

■ IP & competition law – develop and address an interface between the two having regard to TRIPS.

Currently, the national IP policy is still pending.

8.2 Are there any significant developments expected in the next year?

There are no significant developments expected in the next year.

8.3 Are there any general practice or enforcement trends that have become apparent in your jurisdiction over the last year or so?

There were no new trends in the past year.

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South AfricaDe Beer Attorneys

Ntombovuyo Bungane is an associate in the Patents Department at De Beer Attorneys. She is an admitted attorney of the High Court of South Africa. Ntombovuyo obtained her Doctor of Philosophy (Medical Chemistry) degree from the University of Cape Town. She later obtained her LL.B. degree from the University of South Africa. She also completed a diploma in Business Management from the Business Management Training College of Southern Africa in association with the Institute of Business Management.

Prior to joining De Beer Attorneys, Ntombovuyo began her career as a Chemistry lecturer and subsequently worked at one of the large intellectual property law firms in Gauteng, where she gained invaluable experience in patent prosecution. Having previously worked in technology transfer offices within various universities in South Africa, she was exposed to different kinds of inventions and has even held a managerial role in one of these offices. Ntombovuyo is skilled in intellectual property management and is well informed about the commercial aspects of intellectual property.

Ntombovuyo specialises in the drafting, prosecution and enforcement of domestic and foreign patent applications and patents relating to the pharmaceutical, chemical and associated fields, and attends to design registration matters. She also attends to the drafting of commercial IP agreements and IP due diligences.

Ntombovuyo BunganeDe Beer Attorneys21 Dreyer Street302 E, Sunclaire BuildingClaremontCape Town 7708South Africa

Tel: +27 21 100 4545Email: [email protected]: www.debeerattorneys.com

Elaine BergenthuinDe Beer Attorneys21 Dreyer Street302 E, Sunclaire BuildingClaremontCape Town 7708South Africa

Tel: +27 21 100 4545Email: [email protected]: www.debeerattorneys.com

With offices in both Johannesburg and Cape Town, De Beer Attorneys is a South African law firm specialising in all aspects of intellectual property law, including patents, trademarks, design rights and copyright, in South Africa and the African continent. We can also assist with commercialisation of intellectual property including IP valuations, licensing arrangements and the like.

Elaine Bergenthuin is a managing partner at De Beer Attorneys. Elaine has a wealth of experience in both prosecution and litigation of all forms of intellectual property.

She is a qualified electronic engineer, a registered South African Patent Attorney and an Admitted Attorney of the High Court of South Africa. She has over 10 years of experience in the legal industry, both locally and abroad.

Elaine spent a number of years working at a leading firm of Chartered and European patent attorneys in London, who specialise in obtaining patent protection for software, business methods and related technologies. Here she was instrumental in securing patent protection for the technology developments of large multinational companies such as Samsung Technologies, Hewlett Packard and Good Technology (whose patent portfolio was sold to Apple Inc.). During this time, she also assisted in securing a US$68 million win for Good Technology in the European leg of its multinational patent litigation dispute with Research in Motion (makers of the Blackberry).

She has also acted on behalf of industry leaders in the ICT and telecommunication sectors in South Africa with regard to their intellectual property requirements, including successfully representing clients in patent and trademark-related matters before the High Court of South Africa.

Elaine has a detailed commercial acumen, having applied her skills in the commercial sphere as an in-house legal advisor for a large multinational company for a number of years. She therefore has the unique ability to combine her in-depth, international skills and experience in intellectual property with the commercial considerations of local companies.

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Chapter 24

Elzaburu

Spain

than in common law countries, and is generally limited to accounts information. Success of the discovery depends to some extent on the cooperation of the adverse party, as no penalties comparable to those for contempt in common law jurisdictions exist. Third parties are generally not subjected to any type of discovery. Discovery before the initiation of proceedings is requested by filing a submission which sets out the factual and legal grounds as well as any documentary evidence. If opposed, this can lead to a Summary Hearing, where witness and expert evidence would typically be heard.Discovery within the main proceedings must be made in the initial claim, and will be reviewed in the Preliminary Hearing as part of the proposal of evidence. This is very straightforward, and is usually automatically granted without any consideration of the likelihood of success of the action, which is often upsetting for defendants.

1.4 What are the steps each party must take pre-trial? Is any technical evidence produced, and if so, how?

Following filing of the claim, the Court itself carries out service on the defendant, who receives a time limit of two months to file an answer to the claim, following the same rules on arguments and documentary evidence as set out for the claimant in question 1.2 above. The Court will then set a date for the Preliminary Hearing, at which the parties are required to state which facts they admit and which facts they dispute. The judge then fixes the facts under dispute and allows each party to make a proposal regarding evidence to be heard at the trial in order to decide the matters under dispute, i.e. no evidence may be proposed in regard to a matter not under dispute. All documentary evidence, including expert witness reports, will have been filed at this stage. However, no consideration of this or any other evidence takes place before the trial.

1.5 How are arguments and evidence presented at the trial? Can a party change its pleaded arguments before and/or at trial?

The evidence proposed and accepted at the Preliminary Hearing is heard at trial in this order: examination of parties; witnesses; expert witnesses; inspection of items by the judge; and viewing or hearing of recordings. Each party first examines, followed by cross-examination, with no re-direct. In each case, the plaintiff’s evidence is heard first. In general, pleaded arguments may not be changed after the initial claim and answers have been filed. Limited changes are allowed at the Preliminary Hearing, but only if the defendant raises an unexpected fact or argument. No changes are allowed thereafter.

1 Patent Enforcement

1.1 Before what tribunals can a patent be enforced against an infringer? Is there a choice between tribunals and what would influence a claimant’s choice?

A patent can be enforced by filing an infringement claim before the Mercantile Courts specialised in patent matters, which are located in Madrid, Barcelona and Valencia. If the infringer’s domicile or the place of infringement is within the regions around these three cities, the claimant can choose either one. If not, the claimant can choose any of these three cities. The most common choices are Madrid and Barcelona.

1.2 What has to be done to commence proceedings, what court fees have to be paid and how long does it generally take for proceedings to reach trial from commencement?

A claim must be filed. This is a one-step process whereby all factual and legal arguments on the merits must be given in the initial claim submission with no opportunity to do so later, due to the very drastic rule of preclusion which is applicable under the Spanish procedure. This rule also obliges the claimant to file all documentary evidence, including expert reports, at the same time, again with no opportunity to do so later. Court fees in Spain are quite low, and would usually lie below €3,000 for the first instance. The Court, having checked that the claim meets the formal requirements, serves the defendant with notice of the claim, giving him two months to answer. The Court then sets a date for a Preliminary Hearing, in which the facts under dispute are fixed and the judge decides which evidence will be heard. The trial date is set at this Hearing, which is usually around 12 months after the filing date, depending on the Court’s workload.

1.3 Can a party be compelled to disclose relevant documents or materials to its adversary either before or after commencing proceedings, and if so, how?

Discovery may be sought both before and/or after initiating proceedings. If requested before initiation of proceedings, then a prima facie case must be established and the request is subjected to a proportionality review. Paradoxically, this is not the case where it is requested within the main proceedings, where it is normally granted automatically. The extent of disclosure is far more limited

Colm Ahern

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1.13 Does the scope of protection of a patent claim extend to non-literal equivalents?

The doctrine of equivalents, pursuant to the Protocol on the Interpretation of Art. 69 EPC, has been consistently applied by the Spanish courts. This was given explicit expression in the new 2015 Spanish Patent Act, in which Art. 2 of the Protocol is transcribed almost word for word.

1.14 Can a defence of patent invalidity be raised, and if so, how? Are there restrictions on such a defence e.g. where there is a pending opposition?

Invalidity can be raised within the infringement proceedings, either as a defence plea with effect only between the parties, or as a counterclaim seeking the revocation of the patent. It may be raised in parallel to an opposition which can lead to contradictory rulings on the substantive issues.

1.15 Other than lack of novelty and inventive step, what are the grounds for invalidity of a patent?

Other grounds for invalidity include that: the patent is not an invention; the patent has no industrial application; the patent comes under an absolute exclusion e.g. business method or software; the patent is contrary to public order; the patent has insufficient disclosure; the patent goes beyond the scope of the content of the original application; the scope of the patent has been extended after grant; and the proprietor is not entitled to the patent.

1.16 Are infringement proceedings stayed pending resolution of validity in another court or the Patent Office?

Proceedings may be stayed by the Court upon application of one of the parties in the case of Court proceedings, provided that both sets of proceedings may not be joined into one. The agreement of both parties is required in the case of administrative proceedings, e.g. opposition proceedings at the EPO. Revocation proceedings of a granted Spanish national patent can only be brought before a court.

1.17 What other grounds of defence can be raised in addition to non-infringement or invalidity?

The other grounds for defence include: statutory limitations (e.g. private use, Bolar exception); exhaustion of rights; prior use right; and where it can be shown that action has already been brought against the person who has placed the infringing product on the market.

1.18 Are (i) preliminary, and (ii) final injunctions available, and if so, on what basis in each case? Is there a requirement for a bond?

Yes. Preliminary injunctions are granted where (i) urgency, and (ii) a prima facie case can be shown. Final injunctions are granted after trial on the merits and are subject to a daily penalty for incompliance which will be set in the first instance judgment. When granting a preliminary injunction, the court will set the amount of a bond to cover any damages which might be caused.

1.6 How long does the trial generally last and how long is it before a judgment is made available?

Trial length is usually a morning session on one day although this sometimes runs into a second day if there are a lot of expert witnesses. Judgment is rendered in writing within about two months, although this may take much longer if the court has a large backlog.

1.7 Are judgments made available to the public? If not as a matter of course, can third parties request copies of the judgment?

Most judgments are available on publicly accessible databases in redacted form. Any third party with an interest may obtain access to those that are not available on such databases.

1.8 Are there specialist judges or hearing officers, and if so, do they have a technical background?

Spanish judges only receive legal training and rely on expert witnesses with regard to technical matters. The Mercantile Courts of Madrid, Barcelona and Valencia are specialised in certain areas of law, including patent law.

1.9 What interest must a party have to bring (i) infringement, (ii) revocation, and (iii) declaratory proceedings?

Only right-holders and/or exclusive licensees can normally bring an infringement action. Proceedings seeking revocation or a declaratory judgment of non-infringement can be brought by any third party without the need to show a particular interest.

1.10 If declarations are available, can they address (i) non-infringement, and/or (ii) claim coverage over a technical standard or hypothetical activity?

Declaratory judgments are available exclusively for non-infringement to an adversely affected party. The claimant must be either exploiting the potentially accused product or have made real and effective preparations to do so. Hypothetical cases are not allowed. Non-infringement of a product meeting a technical standard could be pursued, provided that such a product were a reality in the sense outlined. Hypothetical claim coverage over a technical standard could not be the subject of a declaratory action.

1.11 Can a party be liable for infringement as a secondary (as opposed to primary) infringer? Can a party infringe by supplying part of, but not all of, the infringing product or process?

The answer to both questions is yes. Art. 60 of the 2015 Spanish Patent Act mirrors the rules on indirect infringement contained in Art. 26 of the 89/695/EEC Agreement relating to Community Patents.

1.12 Can a party be liable for infringement of a process patent by importing the product when the process is carried on outside the jurisdiction?

Importation of the product directly obtained from the process is an act of infringement.

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1.26 For jurisdictions within the European Union: What steps are being taken in your jurisdiction towards ratifying the Agreement on a Unified Patent Court, implementing the Unitary Patent Regulation (EU Regulation No. 1257/2012) and preparing for the unitary patent package? For jurisdictions outside of the European Union: Are there any mutual recognition of judgments arrangements relating to patents, whether formal or informal, that apply in your jurisdiction?

Spain is neither a party to the Agreement nor to the enhanced cooperation underlying the Regulation.

2 Patent Amendment

2.1 Can a patent be amended ex parte after grant, and if so, how?

A patent cannot be amended post-grant by way of application to the Spanish Patent and Trademark Office.

2.2 Can a patent be amended in inter partes revocation/invalidity proceedings?

The patent owner may in his answer to the invalidity claim or counterclaim request that the court consider amended claims. He may also request leave to file an amendment at the SPTO.

2.3 Are there any constraints upon the amendments that may be made?

The amendment must be a limitation of the scope of the patent.

3 Licensing

3.1 Are there any laws which limit the terms upon which parties may agree a patent licence?

No, there are not.

3.2 Can a patent be the subject of a compulsory licence, and if so, how are the terms settled and how common is this type of licence?

A compulsory licence may be granted by the Spanish Patent and Trademark Office on four grounds: the patent is not sufficiently exploited; dependent patents; to end practices which infringe competition law; and public interest. Compulsory licences are extremely rare in Spain.

4 Patent Term Extension

4.1 Can the term of a patent be extended, and if so, (i) on what grounds, and (ii) for how long?

A patent term cannot be extended, except in the case of medicinal products availing of a supplementary protection certificate of up to five years from the date of patent expiry (five-and-a-half years if the product is for paediatric use) under EU Regulation 469/2009.

1.19 On what basis are damages or an account of profits assessed?

The plaintiff can choose between (i) the infringer’s profit or his own lost profit, and (ii) equivalent royalty. Assessment is usually carried out by a court-appointed auditor within the infringement proceedings.

1.20 How are orders of the court enforced (whether they be for an injunction, an award of damages or for any other relief)?

If the defendant does not comply within one month, enforcement proceedings must be brought.

1.21 What other form of relief can be obtained for patent infringement? Would the tribunal consider granting cross-border relief?

Other forms of relief include: cessation of all infringing acts, e.g. offering for sale; seizure; transfer of ownership of infringing products to the plaintiff; transformation or destruction of infringing products; and publication of the ruling. Cross-border relief has never been granted.

1.22 How common is settlement of infringement proceedings prior to trial?

While settlements are common enough, they are nowhere near as common as in some common-law jurisdictions due to the lower cost of going to trial in Spain. Therefore, a more stubborn party has less incentive to avoid a trial.

1.23 After what period is a claim for patent infringement time-barred?

An infringement action is time-barred after five years from the time when it could have been brought.

1.24 Is there a right of appeal from a first instance judgment, and if so, is it a right to contest all aspects of the judgment?

All aspects of the first instance judgment of the Mercantile Court may be contested in second instance before the Appeal Court.

1.25 What are the typical costs of proceedings to first instance judgment on (i) infringement, and (ii) validity? How much of such costs are recoverable from the losing party?

Typical costs on infringement are €70,000 to €150,000. Similar figures are applicable on validity. Costs of approximately €60,000, €80,000, and €90,000 can be recovered, in e.g. the Madrid courts, for claim values of €1 million, €2 million, and €3 million, respectively. Thereafter, 0.5% of the remaining claim value is applicable.

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7 Antitrust Law and Inequitable Conduct

7.1 Can antitrust law be deployed to prevent relief for patent infringement being granted?

Spanish competition law contains provisions concerning abuse of dominant position similar to those contained in the Treaty on the Functioning of the European Union. A defendant in a patent infringement suit could bring an action based on abuse of dominant position via a counterclaim.

7.2 What limitations are put on patent licensing due to antitrust law?

EU Regulation 316/2014 on technology transfer agreements can be used to prevent agreements whereby two competitors use a licensing agreement to share out markets between themselves, or where an important licence-holder excludes competing technologies from the market. Agreements between competitors whose combined market share is less than 20% are exempt. The figure is 30% for non-competitors.

8 Current Developments

8.1 What have been the significant developments in relation to patents in the last year?

1. The Spanish Patent Act of 24 July 2015 came into force on 1 April 2017. Changes include the elimination of the non-examination prosecution track, previously chosen by over 90% of applicants for Spanish patents, and also elimination of the local novelty and inventive requirements for utility models, which are now to be judged against the same worldwide prior art as patents.

2. The regulations implementing the 2015 Patent Act also came into force on 1 April 2017.

8.2 Are there any significant developments expected in the next year?

The first case-law on aspects which have changed in the 2015 Patent Act will make for an interesting year.

8.3 Are there any general practice or enforcement trends that have become apparent in your jurisdiction over the last year or so?

The level of patent litigation has held up well in Spain despite the economic crisis. This may have to do with the fact that patent applications are growing significantly, in addition to the tendency of competitors to cut more corners when market share is threatened.

5 Patent Prosecution and Opposition

5.1 Are all types of subject matter patentable, and if not, what types are excluded?

The Spanish Patent Act essentially mirrors the exclusions of Arts 52 and 53 EPC, e.g. scientific discoveries, business methods, software, against public order, surgical methods, etc.

5.2 Is there a duty to the Patent Office to disclose prejudicial prior disclosures or documents? If so, what are the consequences of failure to comply with the duty?

No, there is not.

5.3 May the grant of a patent by the Patent Office be opposed by a third party, and if so, when can this be done?

There is a post-grant opposition period of six months following publication of the mention of grant. Utility models are subject to a pre-grant opposition, which can be filed within two months of publication of the application.

5.4 Is there a right of appeal from a decision of the Patent Office, and if so, to whom?

The decision to grant or not to grant may be appealed to the courts. The latter may only be appealed by a party who has previously filed opposition proceedings.

5.5 How are disputes over entitlement to priority and ownership of the invention resolved?

Ownership disputes are settled in the civil courts. Any matter concerning priority could be included in the appeal in the administrative courts against the decision to grant or not to grant.

5.6 Is there a “grace period” in your jurisdiction, and if so, how long is it?

The Spanish Patent Act has an extremely restrictive grace period of six months, which is almost identical to that provided for under Art. 55.1 EPC (abuse and officially recognised exhibitions).

5.7 What is the term of a patent?

The term of a patent is 20 years from the date of filing.

6 Border Control Measures

6.1 Is there any mechanism for seizing or preventing the importation of infringing products, and if so, how quickly are such measures resolved?

EU Regulation 608/2013 concerning customs enforcement of intellectual property rights applies. A decision granting or rejecting an application is taken within 30 working days.

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Colm AhernElzaburu Miguel Ángel 21 28010 Madrid Spain

Tel: +34 91 700 9400Fax: +34 91 319 5163Email: [email protected]: www.elzaburu.es/en

Colm Ahern is a Spanish lawyer and an Irish engineer with more than 30 years of experience. He specialises in patent litigation, where his engineering training has been key in infringement and invalidity cases involving technologies as diverse as chemicals and pharmaceuticals, telecommunications, satellite navigation, solar energy and mechanical devices. He has occupied management positions in multinationals in the automotive, domestic appliance and electronics industries, which gives him a special perspective in litigation and negotiation. He is included in the World Intellectual Property Organization Arbitration and Mediation Center’s List of Experts. Moving freely between English, Spanish and German, he has a largely international practice.

Elzaburu is a multidisciplinary Spanish professional firm established in 1865, made up of members with a range of different knowledge areas who place all of their knowledge and efforts at the service of their clients in order to protect and defend their clients’ image, inventions and creations.

Elzaburu’s 360º vision enables our firm to furnish dependable advice on all aspects of industrial property, intellectual property, information technologies, and the commercial and financial aspects of intangible assets.

Elzaburu’s lawyers, engineers, chemists, biotechnologists, and other professionals have the necessary professional and business focus to meet the needs of clients in all walks of business.

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Advokatfirman Lindahl KB

Sweden

As mentioned above, the courts have the power to give search orders and/or information orders and such orders remain available when proceedings have been initiated.

1.4 What are the steps each party must take pre-trial? Is any technical evidence produced, and if so, how?

A licensee bringing an infringement action must inform the patentee of the action in advance. While not strictly a legal requirement, a claimant often should send a warning letter detailing its claim and requesting the respondent to comply with the claimant’s position. Failure to do so before litigation may result in consequences in the courts’ award of costs. Once the proceedings commence, the parties will normally exchange a number of written briefs, and a preliminary hearing is held by the court to discuss the case and possible settlement. Parties are free to submit any evidence and in whichever form they wish.

1.5 How are arguments and evidence presented at the trial? Can a party change its pleaded arguments before and/or at trial?

At the main hearing, arguments and evidence must be presented orally, but references to previously written statements and documentary evidence is often permissible and encouraged. Before the hearing, the parties may change or amend their arguments on facts – provided that the changes or amendments do not go beyond the subject matter of the proceedings. If the court has not used its power to close the record in advance of the hearing, the parties may change arguments on fact at trial, insofar as the court does not hold the change to be made in bad faith or out of gross negligence. Pure arguments on law may be changed freely throughout the proceedings.

1.6 How long does the trial generally last and how long is it before a judgment is made available?

The length of a trial varies from case to case; a reasonable expectation is for a normal infringement trial to take up to one week. It normally takes six weeks before the judgment is handed down, but this depends on the circumstances and timing of the trial.

1 Patent Enforcement

1.1 Before what tribunals can a patent be enforced against an infringer? Is there a choice between tribunals and what would influence a claimant’s choice?

Patents are enforced before the Patent and Market Court, which is a specialised court with exclusive jurisdiction over patent disputes. Judgments and orders may be appealed to the Patent and Market Court of Appeal, which is also exclusive and specialised. The Court of Appeal may, at its own discretion, allow appeals to the Supreme Court, which is not specialised.

1.2 What has to be done to commence proceedings, what court fees have to be paid and how long does it generally take for proceedings to reach trial from commencement?

To commence proceedings, the claimant must file a summons application with the Patent and Market Court. The court fee is SEK 2,800. Usually, it takes about 18 to 24 months for proceedings to reach trial from commencement, although the intention of the new specialised courts is to shorten this to 12 months in the first instance.

1.3 Can a party be compelled to disclose relevant documents or materials to its adversary either before or after commencing proceedings, and if so, how?

Before commencing proceedingsPre-trial production orders for specified documents or objects are available in Sweden, but under narrow conditions. In practice, applications for pre-trial production orders are rare. Under the Patents Act, the courts have the power to order searches of the premises of an alleged infringer for evidence and/or order the provision of information. Such orders may be requested before the initiation of infringement proceedings.After commencing proceedingsUnder the Code of Judicial Procedure, a party can obtain a court order for the production of specific documents or specific categories of documents or other objects that may be probative. Witness examination is allowed to identify documents and property that can be relevant. The possibility of obtaining information under the Patents Act (described above) is also available after commencing proceedings.

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1.11 Can a party be liable for infringement as a secondary (as opposed to primary) infringer? Can a party infringe by supplying part of, but not all of, the infringing product or process?

Yes, a party can be liable for secondary infringement when offering or supplying an essential element for using an invention, or when offering or supplying an object that evidently is adequate and meant for use in accordance with the invention.In addition, secondary infringement also covers offering or supplying an object, typically some kind of commodity, that is readily available on the market, if the seller of the object influences the buyer to use it in accordance with the invention (e.g., providing directions for use, operating instructions).

1.12 Can a party be liable for infringement of a process patent by importing the product when the process is carried on outside the jurisdiction?

Yes, the Patent Act prohibits the import of such a product. In practice, the burden of proof for such indirect infringement may be exacting.

1.13 Does the scope of protection of a patent claim extend to non-literal equivalents?

Yes. There is a doctrine of equivalence, which may extend the scope of protection to non-literal equivalents if certain conditions are met.

1.14 Can a defence of patent invalidity be raised, and if so, how? Are there restrictions on such a defence e.g. where there is a pending opposition?

Invalidity may only be raised as a defence to infringement if the defendant also brings independent proceedings for revocation of the patent. Opposition proceedings before the Swedish Patent Office or the EPO do not limit the possibility of an invalidity defence.

1.15 Other than lack of novelty and inventive step, what are the grounds for invalidity of a patent?

Besides lack of novelty and inventive step, a patent can be invalidated on the following grounds: ■ Insufficient disclosure of the invention.■ Lack of support in the application as filed. ■ Expansion of the scope of the patent after grant. The patent can also be invalidated if it has been granted to someone who was not entitled to the invention. An invalidity action based on this ground can only be brought by the person entitled to the invention.

1.16 Are infringement proceedings stayed pending resolution of validity in another court or the Patent Office?

The court has significant discretion in determining whether to stay proceedings and will not by its own motion stay infringement proceedings because the validity of the patent is examined in separate proceedings or at the Patent Office. In general, infringement proceedings are not stayed pending validity proceedings unless the patentee agrees or special circumstances are at hand.

1.7 Are judgments made available to the public? If not as a matter of course, can third parties request copies of the judgment?

Judgments are a matter of public record and may be requested by the general public. The Patent and Market Court of Appeal also publishes many of its judgments on its website.

1.8 Are there specialist judges or hearing officers, and if so, do they have a technical background?

Cases tried at first instance by the Patent and Market Court are normally decided by a panel of two legally qualified judges and two technical judges. The technical judges are specialist judges who are required to have technical or other relevant education as well as experience of patent law. Before the Court of Appeal, cases are normally heard and decided by three legally qualified judges and two technical judges. Patent cases before the Supreme Court are decided solely by legally qualified judges.

1.9 What interest must a party have to bring (i) infringement, (ii) revocation, and (iii) declaratory proceedings?

InfringementPatentees and licensees may bring infringement proceedings. RevocationAnyone who is prejudiced by the patent may bring revocation proceedings. Where a public interest is involved, also the State has standing. In practice, revocation proceedings are rarely if ever held inadmissible for want of prejudice. If the proceedings relate to entitlement to priority, the proceedings may only be brought by a party who asserts title to the patent. Declaratory proceedingsPatentees and licensees may seek declaratory relief if there is ambiguity as to whether the patent protects the claimant against the actions of another party and this ambiguity is prejudicial to the patentee or the licensee. A declaration may also be sought by anyone who conducts or intends to conduct commercial operations which may be prejudiced by the patent.

1.10 If declarations are available, can they address (i) non-infringement, and/or (ii) claim coverage over a technical standard or hypothetical activity?

Declarations are available and there are three requirements for bringing a lawsuit to obtain a declaratory judgment on non-infringement:■ The lawsuit must be brought by a person who conducts or

intends to conduct commercial operations which may be prejudiced by the patent.

■ There is uncertainty regarding whether the claimant is allowed to carry out those operations because of the patent.

■ This uncertainty is prejudicial to the claimant. A declaration cannot cover hypothetical activities as one of the requirements for a declaration is that there must be an uncertainty which is prejudicial to the claimant. This means that there must be some type of intended activity.

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fine, the party awarded that injunction must bring court proceedings on non-observance and payment of the fine.

1.21 What other form of relief can be obtained for patent infringement? Would the tribunal consider granting cross-border relief?

The court may order the recall, change, storage for the remaining patent term, destruction or the taking of any other measure with regard to products infringing the patent. The court may also order the infringer to publicise information on the court’s judgment. We are not aware of cross-border relief having been granted.

1.22 How common is settlement of infringement proceedings prior to trial?

It is fairly common for infringement proceedings to be settled prior to trial.

1.23 After what period is a claim for patent infringement time-barred?

A claim due to patent infringement can only be made for damages that have arisen within five years from the date that the legal proceedings for the claim were initiated.

1.24 Is there a right of appeal from a first instance judgment, and if so, is it a right to contest all aspects of the judgment?

It is possible to appeal a first instance judgment and all aspects of the judgment may be appealed. However, leave to appeal is required for the appeal to be admissible. In patent cases, leave to appeal is generally granted.

1.25 What are the typical costs of proceedings to first instance judgment on (i) infringement, and (ii) validity? How much of such costs are recoverable from the losing party?

The average costs for patent litigation relating to infringement in Sweden in straightforward proceedings can be estimated between EUR 100,000 and EUR 200,000 at the first instance. This is doubled if proceedings also include an action for invalidity, and may be significantly higher in complicated matters. As a main rule, the losing party must reimburse the winning party’s reasonable litigation costs, including attorneys’ fees.

1.26 For jurisdictions within the European Union: What steps are being taken in your jurisdiction towards ratifying the Agreement on a Unified Patent Court, implementing the Unitary Patent Regulation (EU Regulation No. 1257/2012) and preparing for the unitary patent package? For jurisdictions outside of the European Union: Are there any mutual recognition of judgments arrangements relating to patents, whether formal or informal, that apply in your jurisdiction?

Sweden has ratified the Agreement. During 2014, the Swedish Parliament adopted a number of amendments to the Patents Act in order to comply with the Regulation on a unified patent protection and the Regulation on translation arrangements as well as the Agreement on the Unified Patent Court (UPC).

1.17 What other grounds of defence can be raised in addition to non-infringement or invalidity?

In addition to non-infringement and invalidity, an alleged infringer can raise a defence as for having a right based on prior use. This right applies when the alleged infringer has taken considerable steps to use an invention professionally at the time when the patent application is filed.

1.18 Are (i) preliminary, and (ii) final injunctions available, and if so, on what basis in each case? Is there a requirement for a bond?

Preliminary injunctions Preliminary injunctions are available and the court can issue a preliminary injunction under the penalty of a fine if the claimant shows:■ Probable cause that the defendant has infringed the patent.■ That it can be reasonably held that the value of the exclusive

right to the patent will be diminished by the defendant’s continued infringement.

The provisions on preliminary injunctions have been interpreted as requiring the court to observe a rule of proportionality (balance of convenience). A request for preliminary injunction is made as a part of the proceedings on the merits.A preliminary injunction may be issued only if the claimant deposits a security at the Court that covers any damage that the defendant may suffer from the preliminary injunction. Final injunctionIf requested by the claimant, final and permanent injunctions normally follow a finding of infringement, except in exceptional circumstances (for example, where a good faith infringer has admitted infringement and ceased to infringe immediately on notice).In principle, the injunction must reflect the infringing act or the attempted infringing act and refer to the item(s) or processes alleged to infringe the patent.

1.19 On what basis are damages or an account of profits assessed?

Infringement always entitles the patentee (or licensee) to reasonable compensation for the infringing use of the invention. If the infringement was intentional or negligent, the patentee is also entitled to compensation for further losses and damages caused by the infringement. When deciding compensation, the claimant’s loss of sales, damage to the goodwill of the patentee, non-financial damage and the interest of the patentee in preventing infringement are particularly relevant. The court can also consider the profit made by the infringer when calculating the patentee’s loss. However, the main principle is that the patentee shall only be compensated for its actual financial loss. Therefore, account of profits and punitive damages are not considered available under Swedish law.

1.20 How are orders of the court enforced (whether they be for an injunction, an award of damages or for any other relief)?

Judgments are enforced by the Swedish Enforcement Agency. However, where the court has issued an injunction under penalty of a

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4 Patent Term Extension

4.1 Can the term of a patent be extended, and if so, (i) on what grounds, and (ii) for how long?

Only patents for medicinal products and plant protection products can be subject to term extension. This extension of the terms is based on two EU Regulations (Regulations (EC) No 469/2009 and (EC) 1610/96) and is called a Supplementary Protection Certificate (SPC). An SPC can be granted under the conditions that:■ the product is protected by a basic patent in force;■ a valid authorisation to place the product on the market as

a medicinal product or a plant protection product has been granted and this authorisation was the first to place the product on the market; and

■ the product has not already been the subject of an SPC.The extension of the term can be granted for a period of five years. Furthermore, an SPC can be extended by another six months if the product is a medicinal product and the patentee has tested the product’s suitability for children.

5 Patent Prosecution and Opposition

5.1 Are all types of subject matter patentable, and if not, what types are excluded?

Not all types of subject matter are patentable. The types excluded are:■ Inventions which are exclusively:

■ a discovery, scientific theory or mathematical method; ■ an aesthetic creation;■ a scheme, rule or method for performing mental acts,

for playing games or for doing business or a computer program; or

■ a presentation of information.■ Plant varieties or animal breeds.■ Essentially biological processes for the production of plants

or animals.■ The human body at the various stages of its formation and

development, as well as the mere discovery of one of its elements.

■ Inventions where the commercial exploitation would be contrary to public order and morality, e.g. processes for the cloning of human beings.

■ Processes for surgical or therapeutic treatments or for diagnostics to be practised on humans or animals.

5.2 Is there a duty to the Patent Office to disclose prejudicial prior disclosures or documents? If so, what are the consequences of failure to comply with the duty?

No, there is no duty to disclose prejudicial prior disclosures and documents.

5.3 May the grant of a patent by the Patent Office be opposed by a third party, and if so, when can this be done?

Yes, third parties can oppose the grant of a patent within nine months from the day the patent was granted.

2 Patent Amendment

2.1 Can a patent be amended ex parte after grant, and if so, how?

The patentee may request an amendment of the patent claims.

2.2 Can a patent be amended in inter partes revocation/invalidity proceedings?

Yes, a patent can be amended inter partes in revocation/invalidity proceedings.

2.3 Are there any constraints upon the amendments that may be made?

Yes, after the patent has been granted, amendments can only be made to narrow the scope of protection.

3 Licensing

3.1 Are there any laws which limit the terms upon which parties may agree a patent licence?

There is no law that limits the freedom of contract specifically for patent licences. Patent licences are governed by general contractual law and may be held invalid or adjusted under the rules thereof. Competition law may, in certain cases, also limit the parties’ freedom of contract.

3.2 Can a patent be the subject of a compulsory licence, and if so, how are the terms settled and how common is this type of licence?

Yes, a compulsory licence may be granted in four different situations.First, there is a possibility to grant a compulsory licence when the patentee has been inactive and not used the invention in Sweden, and more than three years have passed since the patent was granted and more than four years from the application date, provided there is no acceptable reason for the non-use.Second, a compulsory license may be granted to the proprietor (not the licensee) of a dependent patent if it is reasonable taking the importance of the first invention into account, or if there otherwise are special reasons for a compulsory licence. There is a requirement of reciprocity, so that the original patent also has the right to have a compulsory licence to the dependent patent.Third, a compulsory licence may be granted where it is required by a public interest of particular importance.Finally, a compulsory licence may be granted to someone who is commercially exploiting an invention which is the subject of a patent application, when the application documents were made publicly available, if there are exceptional reasons therefore and if that person was not aware of the application and could not reasonably have become aware.The general terms for the grant of a compulsory licence are that the applicant is presumed to be able to exploit the invention and can demonstrate that he or she has unsuccessfully attempted to obtain a licence on reasonable terms from the patentee.

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7.2 What limitations are put on patent licensing due to antitrust law?

As mentioned above, Sweden is a member of the European Union and EU competition law applies here. See also the answer under question 3.1 above.

8 Current Developments

8.1 What have been the significant developments in relation to patents in the last year?

Sweden has implemented a reform of dispute resolution for IP and patent disputes. On 1 September 2016, specialised courts for the resolution of disputes arising from intellectual property rights, the Patent and Market Court and the Patent and Market Court of Appeal, were created.

8.2 Are there any significant developments expected in the next year?

The Swedish Patent Act is currently under revision with the aim to modernise its provisions and language and harmonise its material rules with those of the Unified Patent Court (UPC) agreement. Although UPC has been expected to come into force, recent developments in the United Kingdom and Germany seem to have delayed this process.

8.3 Are there any general practice or enforcement trends that have become apparent in your jurisdiction over the last year or so?

The threshold for preparatory acts of patent infringement, which was introduced in Swedish legislation through the implementation of the Enforcement Directive 2004/48/EC, is an issue which has been tried in several infringement cases over the past couple of years. The question has not yet been fully clarified in Swedish case law and we expect further developments in this area, particularly in relation to pharmaceutical patents.

5.4 Is there a right of appeal from a decision of the Patent Office, and if so, to whom?

Yes, decisions rendered by the Patent Office can be appealed to the Patent and Market Court. Before the appeal reaches the Patent and Market Court, the Patent Office has to re-examine the appealed decision.

5.5 How are disputes over entitlement to priority and ownership of the invention resolved?

Disputes over entitlement to priority and ownership of the invention are brought before the Patent and Market Court.

5.6 Is there a “grace period” in your jurisdiction, and if so, how long is it?

No, there is no grace period in Sweden.

5.7 What is the term of a patent?

Patents can be maintained for 20 years from the date of application (see also the answer under question 4.1 above).

6 Border Control Measures

6.1 Is there any mechanism for seizing or preventing the importation of infringing products, and if so, how quickly are such measures resolved?

A patentee can notify the Swedish Custom Service if the patentee suspects that infringing products are imported to the Swedish market. If the Custom Service subsequently identifies products suspected of infringing a patent, they shall inform the declarant within one working day. The patentee shall be notified the same day or promptly after the notification of the declarant.

7 Antitrust Law and Inequitable Conduct

7.1 Can antitrust law be deployed to prevent relief for patent infringement being granted?

There has been no case law in Sweden on this issue. Sweden is a member of the EU and EU competition law applies here. FRAND arguments could be used as a defence by an alleged infringer.

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Ludvig Holm Advokatfirman Lindahl KBP.O. Box 1065 101 39 Stockholm Sweden

Tel: +46 766 170 876Email: [email protected]: www.lindahl.se

Annie KabalaAdvokatfirman Lindahl KBP.O. Box 1065 101 39 Stockholm Sweden

Tel: +46 766 170 940Email: [email protected]: www.lindahl.se

Ludvig specialises in intellectual property, marketing law and life sciences, working primarily with dispute resolution and litigation. He regularly assists clients with strategic advice, drafting and negotiating contracts and offering regulatory advice.

Ludvig has significant litigation experience, in particular in cross-border patent and trademark disputes.

Ranked as an “associate to watch” in the Chambers & Partners Europe 2014 and 2015 guides, under Intellectual Property, Ludvig has been described by clients as “down to earth and willing to listen to the client. He is always trying to assist us”.

Lindahl is one of Sweden’s leading legal advisors within intellectual property, and the firm is top-ranked within this area by international ranking institutions. The firm offers expertise in all areas connected to intellectual property, including patent litigation.

Lindahl is one of Sweden’s largest business law firms, with approximately 400 employees in six offices across Sweden. In addition to having the broad capacity of a large firm, Lindahl has cutting-edge competence in IP, life sciences, technology, media, telecom and litigation. The firm also has long and solid experience of banking and finance, capital markets, M&A and real estate. Lindahl has close relationships with other law firms worldwide and supplies legal advice to Swedish and international clients within all areas of business law.

Annie specialises in intellectual property and marketing law, with a particular focus on the life sciences industry and other regulated sectors.

Annie’s patent practice focuses on pharmaceutical patent litigation and she regularly assists clients on cross-border patent disputes. She also advises pharmaceutical clients on IP regulatory issues and disputes, and works with contracts and M&A within her areas of expertise.

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Gros & Waltenspühl

Switzerland

1.4 What are the steps each party must take pre-trial? Is any technical evidence produced, and if so, how?

According to article 37 § 3 PatCA, where a technically trained judge possesses specific expertise, the judge’s expert opinion shall be entered in the court record. The parties therefore do not have to provide technical expert opinions and if they do so it will be considered by the court as a factual allegation of the party providing it.

1.5 How are arguments and evidence presented at the trial? Can a party change its pleaded arguments before and/or at trial?

After the second exchange of written submissions, the factual allegation steps are closed and new facts and new evidence are only admissible at the main hearing under specific and restrictive conditions as stated under article 229 § 1 CPC (ATF 140 lll312, delib. 6.3.2), respectively (1) if they occurred or were discovered after the exchange of written submissions or after the last instruction hearing (proper nova), or (2) if they existed before the close of the exchange of written submissions or before the last instruction hearing but could not have been submitted despite reasonable diligence (improper nova).

1.6 How long does the trial generally last and how long is it before a judgment is made available?

The length of a patent proceeding depends on its complexity and the behaviour of the arguments invoked by the parties. As a general rule, a first instance judgment by the Federal Patent Court takes from one year to 18 months. In case of an appeal, the judgment of the Federal Supreme Court, which is the final instance, can be expected after four to eight further months.

1.7 Are judgments made available to the public? If not as a matter of course, can third parties request copies of the judgment?

All judgments of the Federal Patent Court are published on its website: www.bundespatentgericht.ch/en.

1.8 Are there specialist judges or hearing officers, and if so, do they have a technical background?

The Federal Patent Court is not only composed of judges with legal training, but also of judges with technical training in all technical

1 Patent Enforcement

1.1 Before what tribunals can a patent be enforced against an infringer? Is there a choice between tribunals and what would influence a claimant’s choice?

The Federal Patent Court has exclusive jurisdiction in particular over validity and infringement disputes and the enforcement of its decisions in respect of patents (art. 26 § 1 (a) of the Swiss Federal Act on the Federal Patent Court (Patent Court Act, PatCA)). Therefore, the claimant has no choice of jurisdiction for patent litigation in Switzerland.

1.2 What has to be done to commence proceedings, what court fees have to be paid and how long does it generally take for proceedings to reach trial from commencement?

In order to start the proceeding, a complaint has to be filed before the Federal Patent Court. The court fees depend on the value in dispute and are governed by the extent and difficulty of the matter in dispute, the form of the proceedings, and the financial circumstances of the parties. The Regulations on Litigation Costs at the Federal Patent Court provide tables with the different possible values in dispute. For instance, if the value in dispute is estimated between CHF 200,000 and 1,000,000, the court fees will be between CHF 20,000 and 66,000. For a value in dispute between CHF 1,000,000 and 3,000,000, the court fees will be between CHF 60,000 and 120,000.

1.3 Can a party be compelled to disclose relevant documents or materials to its adversary either before or after commencing proceedings, and if so, how?

In Switzerland, before the main proceeding, the court may order precautionary taking of evidence (art. 158 of the Swiss Civil Procedure Code, CPC) or grant interim measures (art. 261 ff. CPC) for instance to secure evidence, obtain a precise description of the allegedly unlawful processes or products or the seizure of these objects (art. 77 of the Federal Act on Patents for Inventions, Patents Act, PatA). The claimant may file an action for an unquantified debt (art. 85 CPC) and in such a case the court may, for example, condemn the infringer of a patent in the main proceeding to provide all relevant documents in order to determine the amount of infringing pieces and evaluate the damages.

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art on the basis of the teaching of the patent? (accessibility); and (3) after reading the wording of the claims of a patent, would a person having ordinary skills in the art consider the replaced features as a solution of equal value? (equal value). This third question aims to protect third parties that must be able to recognise what is protected by the claims of the patent.

1.14 Can a defence of patent invalidity be raised, and if so, how? Are there restrictions on such a defence e.g. where there is a pending opposition?

Invalidity of patent can always be raised as an exception to an infringement claim or as a counterclaim, being aware that an action for damages may only be brought after the patent has been granted (art. 73 PatA).

1.15 Other than lack of novelty and inventive step, what are the grounds for invalidity of a patent?

In addition to lack of novelty and inventive step, the Federal Patent Court can declare the nullity of a patent (a) if the invention is for instance not a patentable invention as it is a discovery or excluded from patentable subject matter, (b) if the invention is not described in the patent specification in a manner sufficiently clear and precise for it to be carried out by a person skilled in the art, (c) if the subject matter of the patent goes beyond the content of the patent application in the version that determined the filing date, or (d) if the proprietor of the patent is neither the inventor nor his successor in title, nor has a right to the grant of the patent on other legal ground (art. 26 § 1 PatA).

1.16 Are infringement proceedings stayed pending resolution of validity in another court or the Patent Office?

The Federal Patent Court has exclusive jurisdiction over validity of patents (art. 26 § 1 (a) PatCA).

1.17 What other grounds of defence can be raised in addition to non-infringement or invalidity?

In addition to non-infringement or invalidity arguments, it is also possible to argue as a defence that the alleged acts are under an exception to the effects of the patent; such acts include: (a) acts undertaken within the private sphere for non-commercial purposes; (b) acts undertaken for research or experimental purposes in order to obtain knowledge about the subject matter of the invention including its uses; (c) acts necessary for obtaining marketing authorisation for a medicinal product in Switzerland or in countries with equivalent medicinal product control; (d) the use of the invention for teaching purposes at educational institutions; (e) the use of biological material for the purpose of the production or the discovery and development of a plant variety; and (f) biological material that is obtained in the field of agriculture due to chance or is technically unavoidable (art. 9 § 1 PatA). The alleged infringer may also argue that a parallel import is legal due to the exhaustion of the rights, which is quite complex in Switzerland. As a general rule, unilateral regional exhaustion applies for patent-protected goods products placed on the market in Switzerland or within the European Economic Area by the patentee. However, for instance, national exhaustion applies for products such as pharmaceuticals, as the price in Switzerland or in the country in which they are placed on the market is fixed by the state (art. 9a PatA). Prior user right

fields. The list of the judges and their technical background is available on the website: www.bundespatentgericht.ch/en/about-the-court/judges/.

1.9 What interest must a party have to bring (i) infringement, (ii) revocation, and (iii) declaratory proceedings?

As a general rule, a party must have a personal, legitimate interest to bring a civil proceeding. For instance, unlawful use of a patented invention or imitation gives rise to liability (art. 66 PatA). The patentee or any person who holds an exclusive licence, irrespective of the registration of the licence in the Register, is entitled to bring an action for injunction or remedy or claim damages independently, provided this is not expressly excluded by the licence agreement (art. 75 PatA). Any person demonstrating an interest may bring an action to obtain a declaratory judgment, for instance, on the validity of a patent (art. 74 PatA). A revocation claim can be brought as a main claim or as a counterclaim.

1.10 If declarations are available, can they address (i) non-infringement, and/or (ii) claim coverage over a technical standard or hypothetical activity?

Action for declaratory judgment may be brought by any person demonstrating an interest (art. 74 PatA) (see question 1.9).

1.11 Can a party be liable for infringement as a secondary (as opposed to primary) infringer? Can a party infringe by supplying part of, but not all of, the infringing product or process?

The patent confers on its proprietor the right to prohibit others from commercially using the invention. Use includes, in particular, manufacturing, storage, offering, placing on the market, importing, exporting and carrying in transit, as well as possession for any of these purposes (art. 8 PatA). This provision is, however, not exhaustive and also includes imitation (art. 66 § 1 (a) PatA). Furthermore, any person who abets any of the prohibited offences, participates in them, or aids or facilitates the performance of any of these acts is also liable (art. 66 § 1 (d) PatA).

1.12 Can a party be liable for infringement of a process patent by importing the product when the process is carried on outside the jurisdiction?

If the invention concerns a manufacturing process, the effects of the patent also extend to the products directly obtained by that process (art. 8a PatA). Therefore, importing such a product would be prohibited.

1.13 Does the scope of protection of a patent claim extend to non-literal equivalents?

In a recent decision dated October 3, 2016 (4A_131/2016), the Federal Supreme Court confirmed that all three of the following questions must be cumulatively answered in the affirmative in order to establish that a process or device in dispute uses a teaching of a patent despite the fact that one or more features of the claim are not literally reproduced but instead have been replaced by other features: (1) do the replaced features have the same objective function? (same effect); (2) are the replaced features and their same objective function obvious to a person having ordinary skills in the

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1.23 After what period is a claim for patent infringement time-barred?

A claim for infringement is not time-barred, but under exceptional circumstances there might be a date of expiry, e.g. if the patentee remains inactive during a long period of time, from four to eight years, this may be considered as an abuse of right (art. 2 § 2 of the Swiss Civil Code).

1.24 Is there a right of appeal from a first instance judgment, and if so, is it a right to contest all aspects of the judgment?

An appeal against the judgment of the Federal Patent Court is possible on very limited grounds such as the violation of federal law or constitutional rights or inaccurate establishment of the facts (art. 95 and 97 of the Act on the Federal Supreme Court).

1.25 What are the typical costs of proceedings to first instance judgment on (i) infringement, and (ii) validity? How much of such costs are recoverable from the losing party?

The costs depend in particular on the complexity of the case and the value in dispute. Typical costs for a first instance invalidity proceeding might be between CHF 100,000 to CHF 200,000. In case of a counterclaim challenging the validity of the patent, the fees do of course increase because the court will request further court fees based on the value in litigation. The court costs have to be paid by the losing party which also has to pay a part of the other party’s attorney fees. However, the attorney fees awarded to the winning party by the court generally do not entirely cover these costs.

1.26 For jurisdictions within the European Union: What steps are being taken in your jurisdiction towards ratifying the Agreement on a Unified Patent Court, implementing the Unitary Patent Regulation (EU Regulation No. 1257/2012) and preparing for the unitary patent package? For jurisdictions outside of the European Union: Are there any mutual recognition of judgments arrangements relating to patents, whether formal or informal, that apply in your jurisdiction?

As Switzerland is not a member of the EU, according to an opinion of the Court of Justice of the EU, it may not join the Agreement on a Unified Patent Court. Therefore, EPs that are valid in Switzerland and Swiss patents will continue to be subject to the jurisdiction of the Swiss Federal Patent Court. This is a competent and quick specialised jurisdiction using attractive procedural rules such as, for example, the possibility to conduct the proceedings in English. In Switzerland, in particular the Lugano Convention on jurisdiction and the enforcement of judgments in civil and commercial matters applies.

2 Patent Amendment

2.1 Can a patent be amended ex parte after grant, and if so, how?

Amended claims must be supported by the description and cannot be broader than initial claims. A partial surrender of a Swiss patent can be requested by the patentee before the Swiss Federal Institute

(art. 35 PatA), compulsory licence (see question 3.2 hereunder) or, in exceptional circumstances, abuse of right (art. 2 § 2 of the Swiss Civil Code) due to an inaction of the patentee for a long time (see question 1.23 hereunder) may also be invoked.

1.18 Are (i) preliminary, and (ii) final injunctions available, and if so, on what basis in each case? Is there a requirement for a bond?

The Federal Patent Court may order interim measures provided the applicant shows credibly that a right to which he or she is entitled has been violated or a violation is anticipated and the violation threatens to cause not easily reparable harm to the applicant (art. 261 CPC). Such preliminary measures might for instance be (a) to secure evidence, to preserve the existing state of affairs or to provisionally enforce claims for injunctive relief and remedy, (b) a precise description to be made, or (c) the seizure of the concerned objects (art. 77 PatA). The court may make the interim measure conditional on the payment of security by the applicant if it is anticipated that the measures may cause loss or damage to the opposing party (art. 264 § 1 CPC).

1.19 On what basis are damages or an account of profits assessed?

After a first judgment in which the infringement is established, the claimant may request information form the defendant and quantify its claim (art. 85 CPC) calculated on different possible bases, which are compensation (art. 41 ff. of the Swiss Code of Obligations, CO), the refund of benefits under business conducted in the agent’s interests (art. 423 ff. CO) or unjust enrichment (art. 62 ff. CO). The damages can be quite different depending on which legal basis is chosen and punitive or triple damages are not available.

1.20 How are orders of the court enforced (whether they be for an injunction, an award of damages or for any other relief)?

The Federal Patent Court also has exclusive jurisdiction over the enforcement of decisions made under its exclusive jurisdiction (art. 26 § 1 (c) PatCA).

1.21 What other form of relief can be obtained for patent infringement? Would the tribunal consider granting cross-border relief?

In the event of a conviction, the court may order the forfeiture and sale or destruction of the unlawfully manufactured products or equipment, devices and other means that primarily serve their manufacture (art. 69 PatA). The court may also authorise the successful party to publish the judgment at the expense of the opposing party (art. 70 PatA). Provided that the Federal Patent Court has jurisdiction over the cross-border dispute, cross-border injunction might in theory be possible. However, if the defendant challenges the validity of the patent, jurisdiction will be in the country in which the patent was granted.

1.22 How common is settlement of infringement proceedings prior to trial?

On the first hearing, the Federal Patent Court provides the parties with its provisional opinion. On this basis, the parties very often settle their dispute.

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5 Patent Prosecution and Opposition

5.1 Are all types of subject matter patentable, and if not, what types are excluded?

Under Swiss law, excluded from patentability are, for instance, the human body or a naturally occurring sequence or partial sequence of a gene (art. 1a and 1b PatA). Furthermore, inventions whose exploitation is contrary to human dignity or that disregard the integrity of living organisms or that are in any other way contrary to public policy or morality are not patentable. Methods for treatment by surgery or therapy and diagnostic methods practised on the human or animal body, plant varieties and animal varieties or essentially biological processes for the production of plants or animals are also excluded from patentability. However, microbiological or other technical processes and the products obtained thereby, as well as inventions that concern plants or animals, are patentable provided that their application is not technically confined to a single plant or animal variety (art. 2 PatA).

5.2 Is there a duty to the Patent Office to disclose prejudicial prior disclosures or documents? If so, what are the consequences of failure to comply with the duty?

As regards a Swiss patent (which is different form a European patent designating Switzerland), the Swiss Federal Institute of Intellectual Property does not examine novelty and inventive step. The Swiss Federal Institute of Intellectual Property does therefore not request any prior art document.

5.3 May the grant of a patent by the Patent Office be opposed by a third party, and if so, when can this be done?

As regards a Swiss patent (which is different from a European patent designating Switzerland), lack of novelty and/or inventive step can only be invoked by a third party in a proceeding before the Federal Patent Court.

5.4 Is there a right of appeal from a decision of the Patent Office, and if so, to whom?

As regards a Swiss patent (which is different form a European patent designating Switzerland), the administrative decision to grant or not the patent can be appealed before the Federal Administrative Court. However, as the Swiss Federal Institute of Intellectual Property does not examine novelty and inventive step, this is very unlikely in practice.

5.5 How are disputes over entitlement to priority and ownership of the invention resolved?

The Federal Patent Court also has jurisdiction in other civil actions that have a factual connection to patents, in particular concerning the right to patents or their assignment. The jurisdiction of the Federal Patent Court does not, however, preclude that of the cantonal courts (art. 26 § 2 PatCA).

of Intellectual Property. European patent claims can be amended before the European Patent Office.

2.2 Can a patent be amended in inter partes revocation/invalidity proceedings?

The patentee can for instance also amend its patent by reducing the claims during the first instance proceeding before the Federal Patent Court (Federal Supreme Court dated June 2, 2014, 4A_541/2013).

2.3 Are there any constraints upon the amendments that may be made?

The patentee can only reduce the claims provided they relate to the same invention and are supported by the description of the filed patent. Any extension of the patent is prohibited. The patentee may partially surrender a patent by requesting the Swiss Federal Institute of Intellectual Property to (a) revoke a patent claim, (b) limit an independent claim by combining one or more patent claims, which are dependent on it, or (c) limit an independent claim in some other way. In such cases, the limited claim must refer to the same invention and define an embodiment that is included in the specification of the published patent and in the version of the patent application that determined the date of filing (art. 24 PatA).

3 Licensing

3.1 Are there any laws which limit the terms upon which parties may agree a patent licence?

According to a decision from the Federal Supreme Court dated June 28, 2016 (2C_180/2014), agreements which lead to a significant restriction of competition may be sanctioned by antitrust law.

3.2 Can a patent be the subject of a compulsory licence, and if so, how are the terms settled and how common is this type of licence?

Under Swiss law, there are different types of compulsory licences, such as compulsory licences in the field of semiconductor technology (art. 40a PatA), non-exclusive licences for research tools (art. 40b PatA), compulsory licences for diagnostic tools (art. 40c PatA), and compulsory licences for the export of pharmaceutical products (art. 40d PatA). These licences are granted by the Federal Patent Court only if efforts by the applicant to obtain a contractual licence on appropriate market terms within a reasonable period of time have been unsuccessful (art. 40e PatA and art. 26 PatCA).

4 Patent Term Extension

4.1 Can the term of a patent be extended, and if so, (i) on what grounds, and (ii) for how long?

Supplementary Protection Certificates are available for medicinal products and for plant protection products. The maximum extension period is five years (art. 140e and art. 140n PatA).

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7.2 What limitations are put on patent licensing due to antitrust law?

The Federal Supreme Court recently ruled that vertical or horizontal agreements mentioned in article 5 § 3 and 4 of the Federal Act on Cartels and other Restraints of Competition (Cartel Act, CartA) automatically lead in principle to a significant restriction of competition in terms of article 5 § 1 CartA. If such an agreement is not justified by reasons of economic efficiency, it is prohibited by Swiss competition law. Furthermore, sanctions may be imposed under 49a CartA, even if an agreement listed in article 5 § 3 and 4 CartA did not lead to an elimination of effective competition (Federal Supreme Court dated June 28, 2016, 2C_180/2014).

8 Current Developments

8.1 What have been the significant developments in relation to patents in the last year?

The recent case law on infringement by equivalents, as confirmed by the Federal Supreme Court in its decision dated October 3, 2016 (4A_131/2016) (see question 1.13 above), can be considered a significant development.

8.2 Are there any significant developments expected in the next year?

The President of the Federal Patent Court, Dr. Dieter Brändle, will retire at the end of 2017 and be replaced by the new elected President, Dr. Mark Schweizer, starting from January 1, 2018.

8.3 Are there any general practice or enforcement trends that have become apparent in your jurisdiction over the last year or so?

As a general rule, according to the Federal Patent Court, the claims of the patent are not sufficient to be used as prayers for relief. Prayers for relief have to be drafted very carefully in order to allow the enforcement judge to apply them directly without any interpretation.

5.6 Is there a “grace period” in your jurisdiction, and if so, how long is it?

According to article 7b PatA, there is a very limited grace period of six months prior to the application date or priority date in case of (1) an evident abuse in relation to the patent applicant or his legal predecessor, or (2) if the patent applicant or his legal predecessor has displayed the invention at an official or officially recognised international exhibition falling within the terms of the Convention on International Exhibitions of November 22, 1928, which is very unlikely in practice.

5.7 What is the term of a patent?

The maximum term of the patent is 20 years from the filing date of the application (art. 14 PatA).

6 Border Control Measures

6.1 Is there any mechanism for seizing or preventing the importation of infringing products, and if so, how quickly are such measures resolved?

According to Swiss law, assistance is provided by the Customs Administration (art. 86a ff. PatA). Trademark law is, however, more often used in practice for border measures.

7 Antitrust Law and Inequitable Conduct

7.1 Can antitrust law be deployed to prevent relief for patent infringement being granted?

In an older decision under the previous legislation on parallel imports, the Federal Supreme Court considered that antitrust law may apply in particular situation where the patentee had a dominant position (ATF 126 III 129). In a more recent decision about licence agreements, the Federal Supreme Court confirmed that antitrust law may apply (Federal Supreme Court dated June 28, 2016, 2C_180/2014).

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Pascal FehlbaumGros & Waltenspühl9 rue Beauregard1204 GenevaSwitzerland

Tel: +41 22 311 38 33Email: [email protected]: www.gros-waltenspuhl.ch/en

Pascal Fehlbaum joined Gros & Waltenspühl in 2015 having practised for law firms based in Geneva. He specialised in the field of intellectual property law after being admitted to the Canton of Geneva State Bar in 1999. He headed Legal Services, Patents and Designs at the Swiss Federal Institute of Intellectual Property (Swiss Ministry of Justice), the federal agency and competence centre in Switzerland responsible for all matters concerning intellectual property at national and international level. He also worked there in Legal Services, Copyrights and Neighbouring Rights. Previously, Pascal Fehlbaum worked as a lawyer at the Technology Transfer Office of Hospices/CHUV and the University of Lausanne. He received a D.E.A. (Master’s degree) in intellectual property law and wrote his thesis at the University of Geneva on the subject “Perfumery creations: what protection?” awarded by the Professor Walther Hug Foundation. He has authored various articles on intellectual property law.

Gros & Waltenspühl was founded in 1981 and ranks among the most renowned law firms in Switzerland. Its flawless reputation draws demanding customers notably from the fields of business, real estate, sports and luxury. Gros & Waltenspühl is specialised in all fields of intellectual property law. For instance, it provides patent litigation and full service in relation to trademarks and designs, applications and follow-up of the registration proceedings in any country and with the World Intellectual Property Organisation (WIPO), availability searches, watch services, management of renewals, and activities related to the Internet as well as anti-counterfeiting actions are also included in its services. Gros & Waltenspühl has built, since its creation, strong working relationships with many leading law firms throughout the world. These privileged bonds enable Gros & Waltenspühl to advise and represent clients with regard to national as well as international matters.

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Chapter 27

1 Patent Enforcement

1.1 Before what tribunals can a patent be enforced against an infringer? Is there a choice between tribunals and what would influence a claimant’s choice?

The Intellectual Property (IP) Court, established on July 1, 2008, is a specialist court intended exclusively for IP-related cases all over Taiwan and has jurisdiction over all patent infringement actions in Taiwan. Generally, there is no choice between tribunals unless the parties to a patent infringement action otherwise agree to the jurisdiction of a court other than the IP Court. Besides, the judges of the IP Court have more expertise and knowledge specifically regarding intellectual property than those of other district courts, and thus, as a matter of fact, there is no reason for a claimant to choose other tribunals.

1.2 What has to be done to commence proceedings, what court fees have to be paid and how long does it generally take for proceedings to reach trial from commencement?

For initiating a civil lawsuit, the plaintiff (claimant) should submit a civil complaint along with: (1) a patent certificate and specification; (2) suspected infringing item(s) and document/proof of purchase of the suspected infringing item(s) (such as receipt and/or invoice); and (3) an infringement analysis. Court fees must be paid in an amount equivalent to 1% of the value of the claim. It generally takes around three to four months for proceedings to reach trial (the first hearing) from commencement.

1.3 Can a party be compelled to disclose relevant documents or materials to its adversary either before or after commencing proceedings, and if so, how?

A party can be compelled to disclose relevant documents or materials before commencing proceedings, provided that the other party files a motion for evidence perpetuation with the court and the court grants that motion. The movant party must make a preliminary showing that the suspected infringing item(s) is infringing, and also that the evidence to be preserved is in danger of extinguishing or being destroyed, or preservation is necessary for its status quo. After commencing the proceedings, a party in a civil action may move the court to order the opposing party to produce documentary evidence in the opposing party’s possession. The motion must specify the relationship between such documentary evidence and

the disputed fact to be proved, as well as the legal ground for the opposing party’s duty to produce such documents or materials. Under the Code of Civil Procedure, a party has the duty to disclose: (i) documents to which such party has made reference in the course of the proceedings; (ii) documents of which the other party may require delivery or inspection pursuant to applicable laws; (iii) documents which were made for the interest of the other party; (iv) commercial accounting books; and (v) documents which were made in respect of matters relating to the action (the party may refuse to produce such documents on the ground of privacy or trade secrets). Where a party to a patent infringement action fails to produce relevant documents in accordance with a court order without justifiable reasons, the court may, at its discretion: (i) take the opposing party’s allegation with regard to such documents to be true; (ii) impose a fine of up to TWD 30,000 (GBP 600); and/or (iii) force production of such documents by an order of enforcement.

1.4 What are the steps each party must take pre-trial? Is any technical evidence produced, and if so, how?

Before the trial stage begins, the court would request the defendant to submit an answer in response to the claims set forth in the plaintiff’s complaint (for example, non-infringement analysis should be produced for defending against the claim of patent infringement, and/or prior arts information and comparison for challenging the validity of the patent in dispute), and further request the plaintiff to present a written statement for disputed issues based on the defendant’s answer, so as to compile and list the disputed and undisputed issues of the patent infringement action. A copy of each party’s written statements will be served on the adversary, and the court will generally allow appropriate time (usually four weeks) for the adversary to prepare their response. Where invalidity is at issue, the court may exercise discretion to order the Taiwan Intellectual Property Office (Taiwan Patent Office, TIPO) to intervene in the action to provide their technical opinion, although in practice, the court rarely does this. With regard to the issue of infringement, it is also possible for the parties to request that the court designate an experienced organisation or specialist to conduct an assessment of whether the claims are infringed as contended, which, however, is not a mandatory pre-trial procedure; either party may file a motion seeking such assessment at any time during the court’s trial proceedings.

1.5 How are arguments and evidence presented at the trial? Can a party change its pleaded arguments before and/or at trial?

Pursuant to Article 255 of the Taiwan Code of Civil Procedure, after the service of the complaint, the plaintiff may not amend his/

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TIPLO Attorneys-at-Law

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1.10 If declarations are available, can they address (i) non-infringement, and/or (ii) claim coverage over a technical standard or hypothetical activity?

(i) Declarations are available to address non-infringement, provided that the party seeking the declaratory relief has the interest indicated in question 1.9 (iii) above.

(ii) In general, declaratory proceedings can only be initiated in respect of a disputed “legal relation” or “existence or non-existence of facts from which a legal relation arises”. The court is unlikely to entertain declaratory proceedings to address claim coverage over a technical standard or hypothetical activity, as the declaration sought here is not considered to be a “legal relation” or “fact from which a legal relation arises”.

1.11 Can a party be liable for infringement as a secondary (as opposed to primary) infringer? Can a party infringe by supplying part of, but not all of, the infringing product or process?

The Taiwan Patent Act does not expressly provide for liabilities of a secondary infringer. Therefore, no legal basis is available for claiming secondary infringement under the Patent Act. However, patent owners have attempted to rely on Article 185 of the Civil Code (joint liabilities for “instigators and accomplices” of a tort) to seek relief against secondary infringers, with success to a certain extent. For example, a person who supplies the essential parts of an infringing product (but not all of it) to the primary infringer with knowledge that they are to be used for the infringement, or a person who induces or instructs the primary infringer to engage in the act of infringement may be held jointly liable for infringement.

1.12 Can a party be liable for infringement of a process patent by importing the product when the process is carried on outside the jurisdiction?

Under Article 58(2) of the Patent Act, unless otherwise provided for in the Act, the patentee of a patented process shall have the exclusive right to preclude others from using such process and using, selling or importing for the above purposes the products made through direct use of the said process without his/her prior consent. Accordingly, a party can be liable for infringement of a process patent by importing the product, even though the process is carried on outside the jurisdiction.

1.13 Does the scope of protection of a patent claim extend to non-literal equivalents?

Yes. In practice, the Taiwan Court applies the “doctrine of equivalents” (the function/way/result rule) to extend protection to non-literal equivalents, provided that the accused product or process must contain corresponding elements identical or equivalent to each claimed element of the patent under the “all-elements rule”.

1.14 Can a defence of patent invalidity be raised, and if so, how? Are there restrictions on such a defence e.g. where there is a pending opposition?

Yes, this is raised typically as part of the defendant’s answer or other preparatory briefs, along with copies of documents supporting the grounds of invalidity. Absent exceptional circumstances, invalidity should be raised only during pre-trial (preparatory) stages.

her claim or raise additional claims, except in cases where: (i) the defendant agrees; (ii) the amendment or addition of the claim is based on the same transaction or occurrence; (iii) only the demand for judgment for the relief sought is expanded or reduced; (iv) a change of circumstances makes it necessary to replace the original claim with another claim; (v) the claim shall be adjudicated jointly when those who are not parties are joined as parties; (vi) the existence or non-existence of a certain legal relation, based upon which relation the case shall be decided, becomes disputed in the course of the proceeding and an additional claim for a declaratory judgment confirming such legal relation against the defendant is raised; and (vii) it would neither severely obstruct the defendant’s defence nor delay litigation. Where the defendant proceeds orally on the merits without objecting to the amendment or addition of claims, he/she shall be deemed to have agreed to such amendment or addition.It should also be noted that supplementing or rectifying factual or legal statements without changing the claim shall not be deemed an amendment or addition of claims (§256 of the Taiwan Code of Civil Procedure).

1.6 How long does the trial generally last and how long is it before a judgment is made available?

The trial typically consists of more than one day and may span up to four months. A written judgment is generally handed down by the judge two weeks after the trial is closed, a copy of which will be served to the parties about 10 days later.

1.7 Are judgments made available to the public? If not as a matter of course, can third parties request copies of the judgment?

All court judgments relating to intellectual property are available on the search system provided by the Taiwan Judicial Yuan.

1.8 Are there specialist judges or hearing officers, and if so, do they have a technical background?

The judges in the IP Court are all specialist judges with expertise in trying IP cases; some of the judges have a technical background. The Technical Examination Officers, who act as technical assistants to the judges, are mostly senior examiners of the TIPO and all of them have technical backgrounds, as well as experience in patent examination and assessment.

1.9 What interest must a party have to bring (i) infringement, (ii) revocation, and (iii) declaratory proceedings?

(i) The plaintiff must be the owner of the patent, or an exclusive licensee.

(ii) The claimant need not have any interest, except when the purported ground of revocation is that (a) the patent application was not properly filed by all joint owners, or (b) the patent was issued to someone not legally entitled to file for the patent; only an “interested party” (e.g. a party who claims to be the legitimate applicant) can bring revocation proceedings.

(iii) An action for a declaratory judgment confirming a legal relation may only be initiated by a party who has demonstrated that he has immediate legal interest in seeking such a declaration. For example, a party who shows that he is aggrieved by allegations of patent infringement or threats of infringement proceedings may bring an action for a declaration that the defendant’s claim for infringement does not exist.

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infringed and not invalid, and (b) the defendant is currently engaging in infringing activities or is likely to engage in infringing activities in the future. A final injunction should be enforced after and only after a judgment has been rendered and become final with binding effect, and the patentee will not have to furnish a security bond.

1.19 On what basis are damages or an account of profits assessed?

Under Article 97 of the Patent Act, the plaintiff has three options to choose from as the basis for assessing the quantum of damages: (i) the method provided in Article 216 of the Civil Code; the

patentee may claim damages based on the amount of the balance derived by subtracting the profit earned through exploiting the patent after infringement from the profit normally expected through exploiting the same patent, if no method of proof can be produced to prove the damage suffered;

(ii) the profit earned by the infringer as a result of patent infringement; and

(iii) the equivalent amount of royalty that may be collected from exploiting the invention patent under licensing.

Also, under Paragraph 2 of Article 97 of the Patent Act, where the infringement is found to be intentionally committed, the court may, upon request and on the basis of the severity of the infringement, award the damages greater than the loss suffered but not exceeding three times the proven loss.

1.20 How are orders of the court enforced (whether they be for an injunction, an award of damages or for any other relief)?

(i) Court judgments that order the infringer to cease infringement (enjoining the infringer from making and selling infringing products) should take effect after these judgments have become final. Where the infringer continues making/selling infringing products, the court enforcing the judgment will impose on the said infringer a penalty for his/her default in an amount of TWD30,000~TWD300,000. Further, if the said infringer still fails to fulfil what is ordered in the judgment, the said court will further impose an additional penalty for default or take the said infringer into custody. When necessary, the said court, upon the creditor’s motion, may eliminate the consequences of the infringer’s infringing act at the creditor’s costs and expenses. In addition, if the infringer defaults again after completion of the execution against his/her failure in performing the order as mentioned above, the said court may repeat the execution upon the creditor’s motion.

(ii) As for the court judgments that grant an award of damages against the infringer, the creditor may file a motion with the court for seeking compulsory execution of the infringer’s property for satisfaction of the creditor’s claim against the infringer.

1.21 What other form of relief can be obtained for patent infringement? Would the tribunal consider granting cross-border relief?

Upon the plaintiff’s request, the court may order the destruction of infringing goods, raw materials and equipment used for infringing activities or other necessary disposals. Cross-border relief is not available because the Taiwan Patent Act does not contain any provisions regarding cross-border relief, and patent right is subject to the territoriality principle.

1.15 Other than lack of novelty and inventive step, what are the grounds for invalidity of a patent?

The principal grounds are: (i) lack of industrial applicability; (ii) insufficiency of disclosure in the written description (lack of

enablement); (iii) the scope of claims is not supported by the description and

drawings; (iv) pre-grant amendments which exceeded the scope of

specification, claims or drawings originally filed; (v) where the patent application right was jointly owned, the

application was not filed by all joint owners; (vi) the patent was granted to someone not entitled to file for the

patent; and (vii) the home country of the patentee does not accept patent

applications filed by Taiwan nationals.

1.16 Are infringement proceedings stayed pending resolution of validity in another court or the Patent Office?

No. Article 16 of Taiwan’s Intellectual Property Case Adjudication Act requires that the IP Court may not suspend or stay the proceedings pending resolution of validity in the TIPO or the Administrative Court.

1.17 What other grounds of defence can be raised in addition to non-infringement or invalidity?

In addition to the non-infringement or invalidity defence, the infringer may raise the following defences: (i) no damages should be awarded due to the patent owner’s non-compliance with patent marking requirements; (ii) no damages should be awarded because the defendant lacks the subjective intention or negligence on which an award of damages must be based; (iii) the patent was exhausted; (iv) the plaintiff was an exclusive licensee who did not register the licence with the TIPO; and (v) the plaintiff’s claim was time-barred (see question 1.23 below).

1.18 Are (i) preliminary, and (ii) final injunctions available, and if so, on what basis in each case? Is there a requirement for a bond?

Both preliminary and final injunctions are available. (i) A preliminary injunction (known as an “injunction maintain-

ing the temporary status quo”) is granted if the claimant can show that an injunction is necessary to prevent material harm or imminent danger, or other similar circumstances exist. The factors generally considered by the court to determine whether a preliminary injunction is warranted include: (a) the likelihood of success on the merits of the case (both invalidity and infringement would be considered); (b) whether the claimant would suffer irreparable harm absent an injunction; (c) the balance of interests between both parties; and (d) the impact on the public interest (particularly in pharmaceutical cases). Generally, a preliminary injunction will be enforced after and only after the claimant has provided a security bond as ordered. Also, the court will grant the motion upon the respondent’s (defendant’s) providing the court-assessed countersecurity, by which the respondent (defendant) will be exempt from the preliminary injunction.

(ii) Final injunctions are typically granted if the claimant is successful at trial in establishing that (a) the patent is

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so, any foreign national/entity may request from a Taiwan court the recognition of a final foreign judgment to seek compulsory execution in Taiwan. However, a Taiwan court will not recognise a foreign judgment in the following circumstances: (1) a foreign court lacks the jurisdiction in accordance with the laws of Taiwan; (2) a default judgment is rendered against the losing defendant, except in the case where the notice or summons of the initiation of action have been legally served in a reasonable time in the foreign country or have been served through judicial assistance provided under Taiwan’s laws; (3) the content of the foreign judgment or the proceeding of the relevant patent lawsuit is contrary to the public order or good morals of Taiwan; and (4) no mutual recognition is conducted by and between Taiwan and the relevant foreign country. The mutual recognition refers to judgment recognition, instead of recognition of state. Generally, the Taiwan Court recognises a foreign judgment rendered by a foreign court, unless the said foreign court does not expressly refuse to recognise a Taiwan judgment.

2 Patent Amendment

2.1 Can a patent be amended ex parte after grant, and if so, how?

Yes, by filing an application for amendment to the TIPO. (NB: The answers to questions 2.1 through to 2.3 discuss only post-grant amendments.) Upon approval, the amendment will be published by the TIPO in the Patent Gazette. The amendment will have retroactive effect backdated to the filing date of the patent.

2.2 Can a patent be amended in inter partes revocation/invalidity proceedings?

Yes. Inter partes revocation proceedings are filed to the TIPO, in which the patent owner may propose an amendment or the TIPO may, at its discretion, instruct the patent owner to make the appropriate amendment. The TIPO must notify the party seeking revocation of the proposed amendment.

2.3 Are there any constraints upon the amendments that may be made?

In terms of post-grant amendments, the amendments can only be made in accordance with one of the following: (i) to dismiss claims;(ii) to narrow down the scope of claims;(iii) to correct erroneous descriptions or erroneous translation;

and (iv) to clarify ambiguous descriptions. Furthermore, the amendments must not “exceed the scope of disclosure made in the Chinese specification, claims or drawings originally filed” or “substantially expand or alter the scope of claims” in any event except for the correction of erroneous translation.As to the correction of erroneous translation, it cannot exceed the scope of disclosure of the foreign-language specification originally submitted.

1.22 How common is settlement of infringement proceedings prior to trial?

According to our experience, settlement of infringement proceedings prior to trial is not common. Settlement may be reached when the judge renders his/her opinions regarding the claim construction or an interim judgment. However, according to Taiwan Judicial Yuan’s statistics, the rate of settlement in civil cases in the first instance of the IP Court is only 11.8% (approximately).

1.23 After what period is a claim for patent infringement time-barred?

The claim to seek damages for patent infringement is time-barred after a two-year period from when the patent owner becomes aware of the infringement and the infringer, or a 10-year period from the time the infringement takes place, whichever expires earlier.

1.24 Is there a right of appeal from a first instance judgment, and if so, is it a right to contest all aspects of the judgment?

Yes, the losing party (if the party has lost the case in whole or in part) may appeal against the judgment unfavourable to it. While it is generally considered a liberal right to contest all aspects of the judgment, the Court of Appeal will not allow a party to present a new contention or defence, unless it can be shown that the new contention or defence is based on facts that occur after the first instance judgment is handed down or could not have been presented in the first instance due to reasons not imputable to that party.

1.25 What are the typical costs of proceedings to first instance judgment on (i) infringement, and (ii) validity? How much of such costs are recoverable from the losing party?

Costs are incurred mostly from court fees and attorney fees. A court fee is the money that the plaintiff must pay to the court when bringing an action. Court fees are part of “litigation expenses”, which can ultimately be recovered from the losing party. The amount of the court fee is approximately 1% of the value of claim which is to be assessed at the discretion of the court. The level of attorney fees varies depending on how complicated the case is and whether invalidity is raised. The average attorney fees through to a first instance decision for an infringement action where invalidity is not in issue are in the range from TWD 500,000 to TWD 750,000 (GBP 10,000 to GBP 15,000); where invalidity is raised (which is the typical case), the fees range from TWD 1 million to TWD 1.5 million (GBP 20,000 to GBP 30,000). Attorney fees for the first and second instance are to be borne by each party themselves; they are not recoverable from the losing party.

1.26 For jurisdictions within the European Union: What steps are being taken in your jurisdiction towards ratifying the Agreement on a Unified Patent Court, implementing the Unitary Patent Regulation (EU Regulation No. 1257/2012) and preparing for the unitary patent package? For jurisdictions outside of the European Union: Are there any mutual recognition of judgments arrangements relating to patents, whether formal or informal, that apply in your jurisdiction?

Taiwan has not concluded with any other country any agreement on mutual recognition of judgment in relation to patent rights. Even

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the time needed to obtain the said regulatory approval exceeds five years, the granted patent term extension shall be five years.

5 Patent Prosecution and Opposition

5.1 Are all types of subject matter patentable, and if not, what types are excluded?

Article 24 of the Patent Act stipulates that an invention patent shall not be granted in respect of any of the following: (1) animals, plants, and essential biological processes for the production of animals or plants, except processes for producing microorganisms; (2) diagnostic, therapeutic and surgical methods for the treatment of humans or animals; and (3) inventions contrary to public order or morality.

5.2 Is there a duty to the Patent Office to disclose prejudicial prior disclosures or documents? If so, what are the consequences of failure to comply with the duty?

No. Although the Enforcement Rules of the Patent Act provide that applicants “may submit prior art materials related to the claimed invention”, they do not have a duty to disclose prejudicial prior disclosures or documents.

5.3 May the grant of a patent by the Patent Office be opposed by a third party, and if so, when can this be done?

No. A challenge of the grant of a patent by a third party can only be achieved through revocation proceedings brought at the TIPO.

5.4 Is there a right of appeal from a decision of the Patent Office, and if so, to whom?

Yes, decisions of the TIPO can be appealed to the Appeal Board of the Ministry of Economic Affairs on the grounds that the decision is illegal and/or inappropriate; decisions of the Appeal Board can be further appealed to the IP Court on the grounds that the decision is illegal.

5.5 How are disputes over entitlement to priority and ownership of the invention resolved?

Issues as to entitlement to priority are generally determined by the TIPO during prosecution of the patent application. The applicant may appeal the TIPO’s decision to the Appeal Board of the Ministry of Economic Affairs. Disputes over ownership (e.g. between joint inventors, employer and employee or non-related parties) can be brought before the TIPO during revocation proceedings, but as the TIPO tends to advise the parties to seek resolution of the dispute through a civil action where the rules of evidence-taking can better facilitate examination and determination of contested facts, the claimant currently often seeks civil action directly to resolve the ownership issues by requesting the court to order that the patent at issue be transferred to the claimant.

5.6 Is there a “grace period” in your jurisdiction, and if so, how long is it?

Yes, there is a “grace period” in Taiwan; it is six months from the date of the occurrence of the events (Paragraph 3 of Article 22 of the Patent Act).

3 Licensing

3.1 Are there any laws which limit the terms upon which parties may agree a patent licence?

Yes, restrictive terms of a patent licence which result in anticompetitive effects are prohibited under the Fair Trade Act and the Fair Trade Commission Guidelines on Technology Licensing Arrangements. The following are some of the examples listed under Article 6 of the said Guidelines as potential violations of the Fair Trade Act to the extent that they lessen competition or impede fair competition in the relevant market: (i) restrictive arrangements with respect to marketing methods, scope of use or trading counterparts, in order to achieve the goal of market segmentation; (ii) requirements that the licensee purchase, accept, or use other patents not needed by the licensee; (iii) requirements that the licensee exclusively grant back any improvements to the licensed patent; (iv) price-fixing; (v) restrictions on the licensee’s ability to challenge the validity of the licensed patent; and (vi) limitations on output.

3.2 Can a patent be the subject of a compulsory licence, and if so, how are the terms settled and how common is this type of licence?

Yes, an invention patent (but not utility model and design patents) can be the subject of a compulsory licence. Under Article 87 of the Patent Act, the TIPO may grant a compulsory licence to an applicant on one of the following grounds: (i) in order to cope with national emergencies; (ii) to make non-profit use of a patent for enhancement of public welfare; (iii) if the applicant has failed to reach a licensing agreement with the patentee after making commercially reasonable offers to the patentee; or (iv) if a judgment or Fair Trade Commission decision confirmed that the patentee has engaged in anticompetitive conduct with respect to the exercise of its patent rights. The grantee of a compulsory licence should pay to the patentee “appropriate compensation”, which is to be determined by the TIPO in the event that the parties fail to settle the amount. Compulsory licences are not so common in Taiwan; it is our understanding that only two compulsory licences have been granted by the TIPO to date.

4 Patent Term Extension

4.1 Can the term of a patent be extended, and if so, (i) on what grounds, and (ii) for how long?

According to Article 50 of the Patent Act §53 (which came into force on January 1, 2013), for an invention patent directed to a pharmaceutical or agrichemical(s), or the manufacturing process thereof, of which the exploit needs to obtain a regulatory approval pursuant to other acts or regulations (e.g. marketing authorisation required under the Pharmaceutical Affairs Act), if the regulatory approval is obtained after the publication of the concerned invention patent, the patentee may apply for one and only one extension of the patent term of the said invention patent based on the first regulatory approval. The said regulatory approval is only allowed to be used once for seeking patent term extension. Also, the term “pharmaceutical” set forth in the provision does not include any veterinary drug.It should be noted that the extension of the approved patent term shall not exceed the length of time during which the patent cannot be exploited because of the absence of the regulatory approval concerned from the central government authorities in charge of the business. If

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the foreign-language documents are submitted, and applicants may submit priority documents or a foreign patent gazette as foreign-language documents.

(2) Taiwan and Japan have officially launched their cooperative programme for biological materials deposit. Under such programme, an applicant may have the biological materials of his/her patent applications deposited at the depository designated by Japan’s Ministry of Economy, Trade and Industry, and will then have to submit the certification documents furnished by the said designated depository within the statutory time period as proof of the deposit for his/her Taiwanese patent applications.

(3) Where any material retrieved from the Internet is produced as evidence for patent invalidation, the TIPO should determine the admissibility of such material in terms of the following aspects and should also request submission of other supporting evidence, if necessary: (a) Whether the material is available to the public: the

material should be considered available to the public where it is retrieved from the website that does not limit access thereto, and any third party may access the website to retrieve any information therefrom with or without paying fees or application for an ID/password.

(b) Date of availability to the public: the material should carry a date when it is made available to the public. Alternatively, any other evidence or supporting document provided or issued from the website maintainers could prove the date when the material is available to the public. The timestamp is automatically created by the computer or the date/time annotations, such as date of publication for blog posts or edit history of Wikipedia, which are deemed as the date of availability to the public.

(c) Authenticity: the material retrieved from such credible websites as national/foreign governmental agencies, international institutions, academic organisations or the press should be considered as credible and authentic material.

(ii) Extension of Grace Period and Revised Procedural Requirements: (1) Amendments to Article 22 of the Taiwan Patent Act were

given the green light on January 18, 2017 (to be enforced from May 1, 2017). The amended provision of Article 22 extends the grace period from six months to 12 months for future invention patent applications and sets out more lenient requirements for disclosure, with the limitations removed on how the invention is disclosed by the applicant, so as to facilitate publication and circulation of technologies. That is to say, in principle, no invention patent shall be granted to any proposed invention which, before its patent application, has been made public in publications, has been publicly implemented, or has become known to the public, due to its lack of novelty. Notwithstanding the foregoing, under the amended provision, as long as the application is filed within 12 months after the occurrence of the applicant’s disclosure and the disclosure is caused either out of or not out of the applicant’s intention, the said fact of disclosure does not fall into the circumstances specified in the first paragraph of Article 22 or the scenarios where a proposed invention shall be held unpatentable.

(2) Disclosure out of the applicant’s intention means that the disclosure is caused by the applicant’s will or act and is not necessarily made by the applicant himself/herself. On the contrary, disclosure not out of the applicant’s intention refers to the disclosure of the technology of a proposed invention being made against the applicant’s

5.7 What is the term of a patent?

The term of a patent is as follows: for invention patents, 20 years from filing; for utility model patents, 10 years from filing; and for design patents, 12 years from filing.

6 Border Control Measures

6.1 Is there any mechanism for seizing or preventing the importation of infringing products, and if so, how quickly are such measures resolved?

In addition to preliminary injunction, a patent owner may act upon the newly-added provisions of Articles 97-1 to 97-4 (this took effect on March 24, 2014) to file a request in writing with the customs for detention of suspected infringing goods when he/she has a suspicion of infringement, provided that the patent owner shall present the facts of infringement and provide a cash deposit or security equivalent to the duty-paid price of the potentially infringing goods as assessed by the customs. However, the owner of the detained goods may also provide a countersecurity in an amount equivalent to two times the amount provided by the patent owner to have the granted request repealed. In addition, should the patent owner fail to commence an action within 12 days upon receipt of the customs’ notice and notify the customs of his/her initiation of the action, the customs will repeal the detention. Further, where the court determines and establishes the infringement by a final judgment, the owner of the detained goods shall bear the cost arising from demurrage, warehousing, loading, and unloading the detained goods. On the contrary, the patent owner shall be liable for the damages caused by the detention request to the owner of detained goods if the court clears the alleged infringement by a final judgment.

7 Antitrust Law and Inequitable Conduct

7.1 Can antitrust law be deployed to prevent relief for patent infringement being granted?

While antitrust law may impose penalties (fines and/or even criminal charges) on patent owners who abuse their patent rights with anticompetitive consequences, the general view is that it cannot be deployed to render a patent invalid or unenforceable. There has never been a case where a defendant successfully relied on antitrust law to prevent relief for patent infringement being granted.

7.2 What limitations are put on patent licensing due to antitrust law?

See question 3.1 above.

8 Current Developments

8.1 What have been the significant developments in relation to patents in the last year?

(i) The TIPO slightly amended the Examination Guidelines twice in 2016. Some of the highlights of the amendments are summarised below: (1) For patent applications filed with foreign-language

documents, the date of filing should be the date when

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amendment” in the Patent Examination Guidelines (to come into force from January 1, 2017) as summarised below: (1) Change in method of determining whether additional

technical features constitute a “substantive change”: Determination should be made based on whether

a proposed invention with the claims of post-grant amendment can achieve the “inventive purpose” of the pre-grant claims, instead of on whether the claims of post-grant amendment are “genus/species or further defined technical features”. For example, according to the pre-amendment Guidelines, the addition of “additional” technical features was not allowed because it is not “genus/species or further defined technical features” in form. Now, under the amended Guidelines, the determination should be based on whether the additional technical features can achieve the inventive purpose of the pre-grant claims.

(2) More types of “post-grant amendment” are allowed: A post-grant amendment will be allowed for the scenario

of “clarification of ambiguous statement(s)” when a dependent claim containing a reference to another claim is amended as an independent claim.

(ii) Patent Applications Filed in Taiwan The TIPO published the list of top 100 patent applicants for

2016. Among the domestic corporate applicants, TSMC (Taiwan Semiconductor Manufacturing Company Limited) has implemented more active and constructive patent mapping since it broke into the list of top 10 patent applicants in 2013, and thus has surpassed Hon Hai Precision Industry Co., Ltd. to top the ranking with 873 patent applications, followed by ITRI (Industrial Technology Research Institute), which contributed 468 applications in 2016. Always sticking to the No. 1 position, Hon Hai Precision Industry Co., Ltd., however, fell to No. 3 by filing a total of 400 patent applications. As for foreign corporate applicants, Intel led in the list of companies that filed most patent applications (905 applications) in 2016. US-based Qualcomm had filed 616 patent applications in Taiwan in 2016, jumping from No. 13 in 2015 to No. 2 this year, followed by Semiconductor Energy Laboratory at No. 3 with 470 applications.

Observations on the overall invention applications filed by major corporate applicants of all industries are provided below: (1) In the semiconductor industry, TSMC made the utmost

effort to rise and catch up with Intel by filing a total of 873 applications – close to Intel’s 905 applications – which represents a prominent increase by 74% for TSMC. Such progress was also achieved by Samsung, by 30%, with 252 applications.

(2) In the panel industry, LG Display saw a growth of 88% with 98 applications, while Samsung contributed 88 applications. AUO (AU Optronics Corp.) accounted for 268 applications and Innolux Corporation, 56 applications.

(3) Recession took place in the mobile device industry. Apple Inc. filed only 99 applications, and HTC filed 81 applications.

(4) The industry of financial technology had nearly the same performance as in 2015, with Alibaba Group filing 111 application and Chunghwa Telecom, 160 applications.

(5) In the robotics industry, 14 applications were contributed by Nidec Sankyo Corporation, and 33 applications by HIWIN Technologies Corp.

will (including the scenarios that the disclosure is made out of mistaken understanding or by negligence).

(3) The provision of a grace period does not apply to the circumstance where the technology of a proposed invention is part of other patent application(s) that has (have) been filed by the same applicant in Taiwan or in other countries, and thus the said technology has been made public along with the said earlier application(s) having been disclosed and made public in public or patent gazettes.

(4) Relaxation of procedural requirements: it is no longer mandatory to claim a grace period simultaneously on the date of filing. That is, the original procedural requirement that the fact and date of disclosure should be provided at the time of filing and the supporting documents of the disclosure should be provided within the time period designated by the patent authority, has been removed.

8.2 Are there any significant developments expected in the next year?

(i) The TIPO is also researching and preparing a new Examination Guideline with respect to the requirement of inventive step. The new version will provide more clarifications on the following issues:(1) Definition of the person having ordinary skill in the art of

the subject invention.(2) Definition of obviousness.(3) Examination Guidelines for the inventive step requirement

(the principles of overall examination, comparison, claim-by-claim examination, etc.).

(4) Steps for determining the inventive step requirement and other considerations.

(ii) The TIPO will manage to improve the procedures of interview by focusing on the following issues: (1) To amend Operational Procedures for Patent Interviews

by adding a provision that “Request for an interview shall be made in writing and the matter(s) and explanation(s) for the interview should be listed therein”.

(2) To revise “Interview Request Form” and “Interview Communication” by adding the fields, “Version of Application Documents for Interview” and “Matter(s) and Explanation(s) for Interview”, which revisions are to facilitate the applicant’s and the examiner’s pre-interview preparation and mutual communication between them in accordance with the matter(s) for interview as indicated in the Form so as to enhance the efficiency of interview.

(3) To regulate the procedures of interview by formulating “Guidelines for Conducting an Interview” as internal training materials which shall incorporate the required steps and procedures for conducting an interview; for example, identity confirmation, matter(s) of interview confirmation, explanations on the proposed technology, exchange of opinions, and confirmation of records, in consideration of the applicant’s rights and interests.

(4) To revise the current interview record sheet by which the applicant and the examiner are guided to go through the required procedures and conduct the interview, and the applicant is allowed to bring an electronic device to type his/her opinions in the record sheet.

8.3 Are there any general practice or enforcement trends that have become apparent in your jurisdiction over the last year or so?

(i) The TIPO amended the provisions governing “post-grant

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TIPLO Attorneys-at-Law (also Taiwan International Patent & Law Office) was founded in 1965 by Mr. M. S. Lin and a group of professional legal and technical associates specialising in intellectual property rights. With over four decades of evolution, TIPLO is now one of the largest and most reliable intellectual property law firms in Taiwan, with diversified expertise which encompasses IP as well as the general legal services provided by a full-service law firm. TIPLO is currently staffed by over 290 full-time members, many of whom are multilingual professionals fluent in English, Chinese, Japanese, Taiwanese and other languages. TIPLO mainly consists of three departments, namely the Patent, Trademark and Legal Departments. Our patent engineers and attorneys have an average career length to date of more than 10 years, with expertise and experience covering a wide range of technical fields, including electrical engineering, mechanical engineering, applied chemistry, biochemical engineering, biotechnology, pharmaceutical, semiconductor, computer technology and other emerging areas. TIPLO is a leading firm in patent and trademark prosecution, invalidation and opposition proceedings, and infringement assessment and validity appraisal. The proficiency of our Legal Department in IP enforcement – in particular, infringement litigation and coordination of police raids – is also highly recognised by law enforcement institutes of all levels and industries alike, reinforcing TIPLO as one of the most effective law firms representing the interests of its clients.

Mr. H. G. Chen is the Chief of the Legal Department of TIPLO. He has been practising law in Taiwan for more than 30 years. H. G. has extensive experience in the fields of intellectual property, litigation, unfair competition, dispute resolution and general corporate matters. In the late 1980s, he demonstrated an instinctive litigious flair by successfully representing the client in a leading trade dress case in Taiwan before the enactment of the Taiwan Fair Trade Act. He has represented various global corporate clients from Japan, the United States and Europe in patent and trademark litigation, licensing and negotiation in Taiwan, and this illustrious record has won him a reputation as one of the most invincible lawyers in Taiwan. He served as the president of the Taipei Bar Association for the term of May 2005 to November 2006. He was the Director of Intellectual Property Committee of the Taipei Bar Association (1990–1993) and Taiwan Bar Association (1993–1995). He is now an executive member of the Board of Directors of the Asian Patent Attorneys Association (APAA), Taiwan Group, the executive director of the Taiwan Patent Attorneys Association, and the director of the Legal Aid Foundation.

H. G. ChenTIPLO Attorneys-at-Law7th Floor, We Sheng BuildingNo. 125, Nanking East Road, Sec. 2Taipei 10409Taiwan

Tel: +886 2 2507 2811Email: [email protected]: www.tiplo.com.tw

Mr. J. K. Lin became the Director of TIPLO in 1997, after TIPLO’s founder Mr. M. S. Lin passed away. In his tenure thus far as the director of the firm, J. K. has set out to further streamline the hierarchy of the staff and adopted effective formulae leading to significant quality improvement of TIPLO’s patent, trade mark and legal services that accommodate clients’ intensifying needs for IPR enforcement. J. K. also devotes his time to many public speaking events targeted at global corporations and international society, addressing issues of IP concerns, unfair competition and others, and follows in the footsteps of his late father in being dedicated to pro bono activities with NGOs such as the Judicial Reform Foundation, the Taiwan International Law Society and the Taiwan Human Rights Committee, among many others. He is currently on the Board of Directors of the Asian Patent Attorneys Association (APAA), and is president of the APAA’s Taiwan Group.

J. K. LinTIPLO Attorneys-at-Law7th Floor, We Sheng BuildingNo. 125, Nanking East Road, Sec. 2Taipei 10409Taiwan

Tel: +886 2 2507 2811Email: [email protected]: www.tiplo.com.tw

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Chapter 28

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Turkey

of the international notification. It is also possible to demand a time extension within the same two-week period. After the parties exchange two sets of petitions and submit relevant evidence on which they base their petitions and allegations, the court reviews the file and sets a hearing date for the first hearing which is called the “initial examination hearing” in the Civil Procedural Law no. 6100 (“Procedural Law”).It is important to note that before starting legal proceedings, the patent owner may send a notarised letter to the potential infringer as per Article 141 of the IPL. However, this is not a pre-condition to starting proceedings before the IP court.

1.3 Can a party be compelled to disclose relevant documents or materials to its adversary either before or after commencing proceedings, and if so, how?

As per Articles 219 and 220 of the Code of Civil Procedure, the parties are obliged to submit the documents which they, or the opposing party, have cited as evidence, if they are in possession of such documents after the trial has commenced. If they fail or refuse to submit such documents, they must give their reasons for such failure or refusal. In the event that they cannot give a plausible reason for the situation, according to the circumstances of the case, as a sanction the court may accept the statements of the other party to be true.

1.4 What are the steps each party must take pre-trial? Is any technical evidence produced, and if so, how?

With enactment of the IPL, it was settled that there is no mandatory step that must be fulfilled before initiating a negative declaratory action. Article 154 of the IPL states that sending a notarised letter to the patent owner is an optional measure, not a pre-condition to filing an action. According to Article 119 of the Procedural Code, the plaintiff has to demonstrate and submit all evidence supporting his case when filing the action. For instance, if the plaintiff requests the court to render an injunction, the plaintiff shall submit the necessary evidence with its plaint petition supporting the injunction request. If there is evidence which is not available to the plaintiff, the plaintiff is entitled to ask the court to summon such evidences from the relevant authorities. If such evidence is only available to the defendant, the plaintiff is entitled to ask the court to order the defendant to submit such documents to the court. If the defendant fails to do so, it is deemed that the arguments of the plaintiff have been proven. In cases where there is a risk that evidence may change or be destroyed, the plaintiff may apply for discovery of evidence per

1 Patent Enforcement

1.1 Before what tribunals can a patent be enforced against an infringer? Is there a choice between tribunals and what would influence a claimant’s choice?

A patent can be enforced before specialised Intellectual Property (“IP”) courts. It is worth noting that IP courts are found only in larger cities, i.e. Istanbul, Ankara and Izmir. If there is no IP court in a city, a patent can be enforced before non-specialised civil courts of first instance in that city. Article 156 of the Intellectual Property Law no. 6769 (“IPL”) regulates which courts are competent to deal with patent disputes. Accordingly, if the patent owner is willing to start legal proceedings, the competent court is the court of the domicile of the plaintiff or of the place where the infringement took place (or of the place where the act of infringement produced effect). Where the plaintiff is not domiciled in Turkey, the competent court is the court of the location of the business premises of the patent attorney registered before the Turkish Patent and Trademark Institute (the “Institute”) and, where there is no registration of the patent attorney, the court where the headquarters of the Institute is located.If there is more than one IP court in a city, the court which will hear the case is determined automatically by the distribution offices available in court houses. In other words, the plaintiff is not free to choose which IP court (e.g. first, second, etc.) will hear the case.

1.2 What has to be done to commence proceedings, what court fees have to be paid and how long does it generally take for proceedings to reach trial from commencement?

In order to commence proceedings, it is sufficient to file a plaint petition before the competent IP court. Court fees, including an advance on potential court expenses, should be deposited to the court to file an action. These fees amount to approximately EUR 250.On the other hand, once a court action has been filed, the court notifies the action to the defendant party. If the defendant party is domiciled abroad, plaint petition and all evidences should be translated into the official language of the defendant party, and thereafter, the defendant party should be notified officially via an international notification route. In practice, the international notification proceedings may take six months to one year. The defendant should file its first response petition within two weeks

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1.9 What interest must a party have to bring (i) infringement, (ii) revocation, and (iii) declaratory proceedings?

(i) A patent holder whose rights are infringed, or who is under threat of infringement, may file an infringement action as set forth under Article 149 of the IPL.

(ii) Article 138 of the IPL sets out that persons adversely affected/prejudiced, interested official authorities or the Public Prosecutor may request the invalidation of a patent. Moreover, the invalidity of a patent may also be put forward by persons entitled to claim the right to the patent.

(iii) Lastly, pursuant to Article 154 of the IPL, any interested person may institute proceedings against the holder of a patent to obtain judgment of non-infringement of rights conferred by the patent. In practice, generic companies willing to enter the market with a product which could be within the scope of a patent begin such declaratory proceedings.

1.10 If declarations are available, can they address (i) non-infringement, and/or (ii) claim coverage over a technical standard or hypothetical activity?

The IPL explicitly rules on the declaration of non-infringement actions in Article 154 of the IPL.Accordingly, any interested person may file a declaration action against the patent holder to obtain a judgment of non-infringement of rights conferred by the patent. With regards to point (ii), there is no specific provision regulating declaration actions for claim coverage over a technical standard or hypothetical activity. On the other hand, in general terms the determination of the scope of protection of claims is a sub-issue dealt with in infringement actions.

1.11 Can a party be liable for infringement as a secondary (as opposed to primary) infringer? Can a party infringe by supplying part of, but not all of, the infringing product or process?

As per Article 86 of the IPL, a party can be liable for infringement as a secondary (indirect) infringer if a third person hands over to persons unauthorised to work on the patented invention elements and means related to an essential part of the invention, and the subject matter of the patent, and renders possible the implementation of the patented invention. In order for this provision to be applicable, the concerned third party has to know that such elements and means are sufficient for putting the invention to use, and that they will be used to such effect, or that the circumstances render such situations sufficiently evident.

1.12 Can a party be liable for infringement of a process patent by importing the product when the process is carried on outside the jurisdiction?

Yes; importing an infringing product, even when the process is carried on outside of the jurisdiction, falls within the scope of the infringing acts regulated under Article 141 of the IPL. Namely, Article 141/1(c) stipulates that using the patented process or selling, distributing or commercialising in any other way, importing for such purposes, or using by applying the products directly obtained through such patented process, without the consent of the patent holder, are deemed as patent infringement.

Article 400 of the Procedural Code. In this application, the court may discover evidences ex parte, and appoint experts where necessary.

1.5 How are arguments and evidence presented at the trial? Can a party change its pleaded arguments before and/or at trial?

The parties have to submit all arguments and evidence by the initial examination hearing, which is held after the petition exchange phase is completed. At the initial examination hearing, the court grants the parties two weeks’ additional time to submit any missing evidence. According to Article 141 of the Procedural Code, the parties are allowed to change their arguments with their reply petitions. Moreover, at the initial hearing, if a party explicitly consents, the other party may change its claims or arguments. If one of the parties is not present at this initial examination hearing and gives no reason for being absent, the attending party is allowed to change or extend its pleaded arguments freely.In addition, the parties have the right to correct/amend their demand until the end of the trial, as per Articles 176 and 177 of the Procedural Code.

1.6 How long does the trial generally last and how long is it before a judgment is made available?

It generally takes one-and-a-half years before the first instance courts, and about two years before the Court of Appeals to reach a judgment. Recently, Turkey adopted a three-tier appeal system where there is one more stage between first instance courts and the Court of Appeals. This court, also known as the Court of Cassation, may examine the merits of the case and call for another expert examination before rendering a decision. The Court of Cassation has been in operation since July 2016 and it is expected that it will take six to eight months to assess the merits of each case. This period may be longer in case the Court of Cassation decides there is a need for a court-appointed expert examination.

1.7 Are judgments made available to the public? If not as a matter of course, can third parties request copies of the judgment?

According to Article 26 of the Procedural Code, in principle all hearings and decisions are public (Principle of publicity). However, there is no database that makes all judgments available to the public. Third party attorneys are allowed to review a file without obtaining a copy from the file, but only attorneys representing the parties with a power of attorney are allowed to obtain copies of a judgment and other documents from a court’s file.

1.8 Are there specialist judges or hearing officers, and if so, do they have a technical background?

According to Article 156 of the IPL, specialised IP courts have jurisdiction for all of the actions and claims which arise out of IP Law. The judges in Turkish IP courts have a deep understanding of IP law, even if they do not have technical backgrounds.In the early years of the IP courts, judges were given specific training on IP law, but since they have no technical background, they can also refer files to expert panels for technical evaluation. Therefore, the practice of the IP courts has evolved so that disputes are often solved with the help of expert examinations.

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(c) where the subject matter of the patent exceeds the scope of the application or is based on a divisional application filed in compliance with Article 91 (unity of the invention principle), or on an application filed in compliance with Article 110 (Usurpation of the Right to a Patent) and exceeds the scope of the same;

(d) where the holder of the patent does not have the right to a patent in accordance with Article 109 of the IPL; or

(e) where the scope of the patent is exceeded.

1.16 Are infringement proceedings stayed pending resolution of validity in another court or the Patent Office?

Under the IPL or the Procedural Law, there is no specific provision requiring the courts to stay infringement proceedings due to a pending validity matter before another court or Patent Office such as the EPO proceedings. It is at the courts’ discretion to stay infringement proceedings in order to wait for the invalidity issue to be resolved. In case of a national invalidity case, most IP courts either stay the infringement proceedings or decide to consolidate the infringement and invalidation proceedings and evaluate both cases together.With regard to EPO proceedings, in practice if the patent concerns the validation of a European patent, depending on the status of the EPO proceedings, courts may decide to wait for the outcome of the EPO procedure, if it seems it will not be long until is it finalised. Apart from that, IP courts generally prefer not to wait for the EPO proceedings, considering the length of such procedures.

1.17 What other grounds of defence can be raised in addition to non-infringement or invalidity?

As discussed above, the most used tactical defence against infringement attacks is filing an invalidation action against the patent.Additionally, the file history estoppel argument (defined in Article 89/6 of the IPL) can be raised if the patent owner is relying on infringement as per the doctrine of equivalents.Another defence against an infringement case can be raised due to Article 87 which rules about prior user rights: “The patent applicant or the patent owner shall not have the

right to prevent the persons who began to use the invention in good faith or have adopted significant and real measures for its use prior to the application date from continuing to use the invention which is subject to the patent in the same manner or begin to use it in line with the measures adopted. However, the continuation of the use of the invention which is subject to the patent by the referred persons or its use in line with adopted measures shall be at a degree which fulfills the reasonable requirements of the establishment they own. This right for use may only be transferred along with the relevant establishment.”

Accordingly, if the conditions for prior user rights exist then the defendant of an infringement action may depend on this Article against infringement claims.Finally, procedural grounds of the Procedural Law can be raised in addition to the non-infringement and invalidity defences. (For example, as per Article 114 of the Procedural Law, the court must have jurisdiction and the plaintiff must have legal benefit to file the action, etc.)

As a note for process patents, if the product manufactured with the patented process is new, each product manufactured without permission of the patent owner is considered as manufactured with patented process. In this case, the burden of proof is automatically reversed, and it is for the defendant party to prove that the patented process has not been infringed. However, if the product manufactured with a patented process is not new, it is left to the judge’s discretion to decide whether the burden of proof is on the defendant (Article 141/2 of the IPL).

1.13 Does the scope of protection of a patent claim extend to non-literal equivalents?

Yes, as per Article 89/5 of the IPL, in determining the scope of protection conferred by a patent application or a patent at the time of an alleged infringement, all elements equivalent to the elements expressed in the claim(s) shall also be considered (doctrine of equivalence). To be an equivalent, the substitute element must match the function, way and result of the claimed element. In addition, in order to determine the scope of protection of the patent, the declarations of the patent application or declarations of the patent owner which were given during the grant proceedings of the patent or during the validity of the patent will be taken into consideration (Article 89/6 of the IPL).Finally, if the patent includes examples regarding the invention, the claims are not interpreted as limited to these examples. In particular, if the additional features of the product or process described in the patent are not in the examples or such additional features do not include the features described in the examples or the additional features cannot realise each purpose or feature described in the examples, the additional features cannot be excluded from the scope of protection (Article 89/7).

1.14 Can a defence of patent invalidity be raised, and if so, how? Are there restrictions on such a defence e.g. where there is a pending opposition?

Yes, a defence of patent invalidity can be raised either by filing a counter action or a separate action against enforcement of the same patent. The counter action should be pursued within the time period of filing the first response petition in the infringement action, as per Article 133/1 of the Procedural Law.A separate invalidation action can be filed at any time.The restriction brought to the invalidation action is defined in Article 138/2 of the IPL. Accordingly, if the invalidation action is filed at a time wherein the post grant opposition against the same patent is pending, the IP court must delay the invalidity proceedings until the outcome of the opposition.

1.15 Other than lack of novelty and inventive step, what are the grounds for invalidity of a patent?

The grounds for the invalidity of a patent are ruled under Article 138 of the Industrial Property Law. Accordingly, a patent should be declared invalid by a court in the following situations:(a) where the subject matter of the invention does not meet the

patentability requirements as specified under Articles 82 to 83 of the IPL (i.e. novelty, inventive step and applicability in industry);

(b) where the invention has not been described sufficiently according to Article 92 of the IPL;

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It is important to note that the Precautionary Injunction decision must be enforced within one week of the granting of PI. Otherwise, it is automatically lifted. The reasoned decisions and decisions on merits of the courts can be enforced at any time. It is not necessary to wait for the finalisation of the decision (finalisation after appeal) if the subject matter of the case is not related to family law, property law or personal matters. Case law actions related to intellectual property rights are not deemed as a part of property law and therefore can be enforced without waiting for finalisation of the decision.

1.21 What other form of relief can be obtained for patent infringement? Would the tribunal consider granting cross-border relief?

In practice, reverse PI decisions are available as another form of relief that can be obtained for patent infringement. Indeed, we have observed that the IP courts may order PI decisions where the potential infringer is allowed to continue with trade or business, provided that he pays a guarantee amount corresponding to the potential damages of the patent holder. At the end of the proceedings, if the patent infringement is determined, the patent holder may refer to this guarantee amount and also ask for further damages exceeding the guarantee amount.Turkish courts do not have jurisdiction on other countries. Therefore cross-border reliefs are not an option.

1.22 How common is settlement of infringement proceedings prior to trial?

Settlement of infringement proceedings prior to trial is very rare; although it may be the case, especially if the patent holder sent a warning letter to the potential infringer and disclosed its intention to start an infringement trial. This may lead the parties to come together and seek an amicable solution. In particular in pharmaceutical patent disputes, parties mostly refrain from settlements due to the sensitivity of the Competition Authority.

1.23 After what period is a claim for patent infringement time-barred?

A claim for patent infringement can be raised as long as the infringement is ongoing (and within the duration of the patent protection). The logic behind this is that the damages occur with each and every infringing act; therefore, lapse of time is renewed with every infringing action.As the patent infringement act is a kind of unfair act, after the infringement has ceased, the general provisions of the Turkish Code of Obligations determine the period after which a claim for patent infringement will become time-barred. According to these provisions, after two years as of learning about the infringer and the damage or in any case after 10 years as of the occurrence of the unfair act, a claim for patent infringement becomes time-barred.

1.24 Is there a right of appeal from a first instance judgment, and if so, is it a right to contest all aspects of the judgment?

Yes. Turkey adopted a new appeal system which entered into force on July 20, 2016. The new system introduced a three-tier court system; namely first instance courts, Courts of Cassation and Courts of Appeal. In principle, all final decisions of the courts of

1.18 Are (i) preliminary, and (ii) final injunctions available, and if so, on what basis in each case? Is there a requirement for a bond?

In Turkish Patent Law, preliminary injunctions are available, and such injunctions mostly stay in force until the judgment, to be rendered in the main action, becomes final. However, the court may lift the injunction decision in case the conditions are changed and it is brought to the attention of the court by the party subject to the injunction. According to Article 159 of the IPL, persons who have commenced, or will commence, legal proceedings under the IPL, can request for a Preliminary Injunction (“PI”) in order to ensure the effectiveness of the infringement action, on condition that they bring evidence as to the existence of actual use of the patent in Turkey or serious and effective preparations to use the patent in question. The PI requests are accepted when any delay might cause irreparable and significant damage. The success of a PI request totally depends on the quality of evidence that a delay might cause irreparable and significant damage. In practice, the courts refer the file to the expert panels and obtain an expert report before rendering a PI decision. The bond requirement is at the discretion of the court. The court evaluates the characteristics of each case to decide whether or not a bond is required. If the court decides that the party requesting PI shall deposit a bond, then it is obligatory to deposit said bond requirement so that the PI decision can be enforced. If it is not deposited, the decision cannot be enforced, and the PI decision will be revoked ex officio. Security can be in the form of cash or a letter of guarantee. The court determines the amount according to the particulars of the case, i.e. the sales of the product, whether there are other generics in the market, etc.

1.19 On what basis are damages or an account of profits assessed?

There are three bases to calculate the damages according to Article 151 of the IPL:(1) Article 151/1(a) of the IPL: the damages claim is calculated

according to the income which the patent owner might possibly have generated if the competition of the infringing party did not exist. The court-appointed expert panel would examine the patent holder’s commercial books and records along with the infringer’s, in order to determine the loss of profit.

(2) Article 151/1(b) of the IPL: the damages claim is calculated according to the income which is generated by the infringing party from the use of the patent. In this case, the expert examination would be conducted on the infringer’s commercial records.

(3) Article 151/1(c) of the IPL: the damages claim can be calculated according to a licence fee that would have been paid if the party infringing the patent would have lawfully utilised the patent under a licensing contract.

1.20 How are orders of the court enforced (whether they be for an injunction, an award of damages or for any other relief)?

The decisions of courts are enforced according to the Enforcement and Bankruptcy Law numbered 2004 by Enforcement Offices. Parties shall apply to enforcement offices to enforce a court’s decision, i.e. a preliminary injunction decision.

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As concerns amendments, if a European patent is amended, for instance at the opposition stage, such amendment will be reflected in the Turkish validation patent, and if at that stage there is a pending invalidation action in Turkey, such amendment should be taken into account. Therefore, it is very important that Turkish courts stay the invalidation proceedings if there is a pending opposition or appeal process before the EPO.

2.3 Are there any constraints upon the amendments that may be made?

Please refer to question 2.1.

3 Licensing

3.1 Are there any laws which limit the terms upon which parties may agree a patent licence?

Licensing a patent is described under the IPL. There are no provisions limiting the terms upon which parties may agree to a patent licence.

3.2 Can a patent be the subject of a compulsory licence, and if so, how are the terms settled and how common is this type of licence?

Yes. According to Article 129 of the IPL, a compulsory licence can be granted where any one of the following circumstances exists:(i) non-use of the patent;(ii) dependency of the subject matter of the patent;(iii) it is in the public interest;(iv) the export of pharmaceutical products to foreign countries

experiencing public health problems in line with Law no. 6471. The protocol amending TRIPs was accepted in Turkey as of 22 May 2013 by means of Law no. 6471 for the Acceptance of the Protocol Amending the TRIPs Agreement;

(v) a plant breeder cannot develop a new type of plant without infringing a previous patent; or

(vi) the patent holder engages in activities that prevent, distort or restrict competition while using the patent.

In practice, compulsory licensing is very rarely used. We could detect only one case back in 1974 about granting a compulsory licence in a matter related to national security.

4 Patent Term Extension

4.1 Can the term of a patent be extended, and if so, (i) on what grounds, and (ii) for how long?

The term of a patent cannot be extended in Turkey.

5 Patent Prosecution and Opposition

5.1 Are all types of subject matter patentable, and if not, what types are excluded?

According to Article 82 of the IPL, the following, which are not inventions by their very nature, shall remain outside the scope of this law: (a) discoveries, scientific theories and mathematical methods;

first instance can be appealed. Interim decisions, however, can only be appealed along with the final decision. The Court of Cassation examines judgments, including judgments regarding PI requests, as well as the merits of the case. The decision of the Court of Cassation can be appealed to the Court of Appeals.

1.25 What are the typical costs of proceedings to first instance judgment on (i) infringement, and (ii) validity? How much of such costs are recoverable from the losing party?

The main costs arising in a typical patent case including both infringement and validity would be judicial costs (i.e. expert fees) and a fixed attorney fee. Courts set up an expert panel composed of three experts. The fee for each expert examination is around TL 3,000 (approximately EUR 900). A second panel of experts is also likely to be appointed if the first one’s report is found not to be satisfactory. The attorney fee which is determined in line with the annual tariff declared by Turkish Bar Union is TL 2,600 (approximately EUR 665). Therefore, the total costs for such litigation are around EUR 3,000 to EUR 4,000. The losing party shall bear the judicial costs and the fixed attorney fee.

1.26 For jurisdictions within the European Union: What steps are being taken in your jurisdiction towards ratifying the Agreement on a Unified Patent Court, implementing the Unitary Patent Regulation (EU Regulation No. 1257/2012) and preparing for the unitary patent package? For jurisdictions outside of the European Union: Are there any mutual recognition of judgments arrangements relating to patents, whether formal or informal, that apply in your jurisdiction?

There is no mutual recognition of judgment arrangements relating to patents that apply in Turkey for the time being.

2 Patent Amendment

2.1 Can a patent be amended ex parte after grant, and if so, how?

According to Article 99/4 of the IPL, the patent owner may amend the patent upon objections of third parties after publication of the patent grant decision in the Official Bulletin. Article 103/3 of the IPL stipulates that the patent application may be amended during the proceedings before the Institute provided that changes shall not exceed the scope of the application. Further, it stipulates that if the patent is objected to, the patent owner may amend the patent until the Institute gives a final decision on the objection, provided that the amendments do not exceed the scope of protection. Any material mistakes can be amended at any time.The IPL also foresees that regulations will be published on procedures and principles on amendments and relevant applications; such regulations have not yet been published.

2.2 Can a patent be amended in inter partes revocation/invalidity proceedings?

Please refer to question 2.1.Additionally, as Turkey is a contracting state of the EPC, if a patent is revoked before the EPO, Turkish validation of such a European patent is automatically revoked in Turkey too.

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Re-Examination and Evaluation Board decision and before Ankara IP Courts.

5.5 How are disputes over entitlement to priority and ownership of the invention resolved?

There is no rule in the IPL defining a specific route to be followed in case of a dispute over entitlement to priority. In principle, the priority claim of the applicant is examined and evaluated by the Patent Office. The decisions of the Patent Office can be appealed before the Re-Examination and Evaluation Board and the Board decision can be subject to a cancellation action before the Ankara IP Court.On the other hand, there is no specific route where third parties are involved with the priority claim of the patent owner, as non-entitlement of priority is not listed as one of the grounds for opposition or an invalidation action of third parties. However, third parties may challenge the novelty or inventive step of a patent depending on the document on which the patent owner claims priority, by claiming that the patent owner is not entitled to priority over such document and therefore it should be accepted as prior art for the patent in question.In relation to disputes on ownership of the invention, Article 110 of the IPL explicitly rules that: “Allegations, that an applicant of a patent application in fact

does not have the right to claim the patent, should not be made before the Patent Office. Until the contrary is proven, the applicant is deemed to have the right to claim patent.

Persons, who claim to be the true patent owners during patent application procedures, in accordance with the provision of Art. 109, paragraph 1, have to file a lawsuit before the competent court against the applicant and notify the Patent Office of such action. The court may decide to delay the patent granting procedures until the court’s ruling has become final.

In case the decision of the court is finalised in favour of the plaintiff (who claims ownership), within three months of the finalisation of the court decision the plaintiff can:(a) Demand that the pending application should be accepted

as the patent application of his own.(b) File a new patent application for the same invention and

claim priority from the same priority right. In this case, the date of patent application is accepted as the filing date of the first application and the first application is deemed invalid.

(c) Demand that the pending application be rejected. If the plaintiff fails to apply to the Patent Office within three

months of the finalisation of the court’s decision, the patent application is considered to be withdrawn.

Persons who claim a partial right over the patent as co-inventors have the right to take the matter to court in accordance with paragraph 2.

Patent applications that are taken to court in accordance with paragraph 2 cannot be withdrawn without the approval of the plaintiff before the ruling becomes final.

If a patent is granted while court proceedings are ongoing, the case of unlawful application appropriation becomes a case of unlawful patent appropriation.”

On the other hand, as per Article 111 of the IPL, if a patent has been granted to a person other than the rightful owner, the person claiming to be rightfully vested with such right may file an action claiming the transfer of ownership of the patent without prejudice to his other rights and claims conferred by the patent.

(b) plans, methods, schemes/rules for performing mental acts, for conducting business activity and for playing games;

(c) computer programs;(d) creations having an aesthetic characteristic and literary and

artistic works; and(e) presentations of information/data. Patents shall not be granted for inventions in respect of the following subject matter:(a) inventions whose subject matter is contrary to the public

order or to morality as is generally accepted; (b) plant and animal varieties/species or processes for breeding/

plant or animal varieties/species, based mainly on biological grounds, except microbiological processes and products obtained as a result of microbiological processes;

(c) diagnosis methods and surgical methods including all treatment methods to be applied on the human and animal body;

(d) the human body in various stages of its formation and evolution and invention of one of the elements of the human body including a gene sequence or partial gene sequence; or

(e) human cloning processes, process of changing genetic identity of human sexual line, use of human embryo with industrial or commercial purposes, processes of changing genetic identity causing pain to animals without any medical benefit for humans or animals and animals obtained as a result of these processes.

5.2 Is there a duty to the Patent Office to disclose prejudicial prior disclosures or documents? If so, what are the consequences of failure to comply with the duty?

No, there is no duty to the Institute to disclose prejudicial prior disclosures or documents.

5.3 May the grant of a patent by the Patent Office be opposed by a third party, and if so, when can this be done?

According to Article 99 of the IPL, within six months following the publication of the decision of the patent grant, third parties may file oppositions to the grant of the patent. Oppositions and replies of a patent owner to these oppositions are examined by the Re-Examination and Evaluation Board. There is no administrative appeal procedure, so the decision of the Board is final. However, the parties can apply to the IP courts within two months as of the notification of the decision of the Board and demand for the cancellation of the decision.

5.4 Is there a right of appeal from a decision of the Patent Office, and if so, to whom?

First of all, in principle the Patent Office decisions can be appealed before the Re-Examination and Evaluation Board within two months as of notification of the decision.Post grant oppositions are filed before and evaluated by Re-Examination and Evaluation Board. The IPL does not allow the decision of the Re-Examination and Evaluation Board to be appealed before the same Board again. Therefore, Article 99 of the IPL rules that the decisions on post-grant oppositions are final.Every decision of the Re-Examination and Evaluation Board can be subject to a cancellation action before the IP Court. Such an action should be filed within two months as of notification of the

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7.2 What limitations are put on patent licensing due to antitrust law?

To the extent of our knowledge, there has not yet been any case where patent licensing is limited due to antitrust law.

8 Current Developments

8.1 What have been the significant developments in relation to patents in the last year?

The Industrial Property Law (referred to as the IPL above) entered into force on 10 January 2017 and replaced the Patent Decree Law numbered 551. The IPL includes provisions regarding patents and also trademarks, geographical indications, designs and utility models.With regard to patents, the major changes are:(i) The introduction of post-grant opposition proceedings, as

explained under question 5.3 above.(ii) The abolition of seven-year patents.(iii) A revision of the compulsory licensing system, as explained

under question 3.2 above.

8.2 Are there any significant developments expected in the next year?

We are awaiting developments regarding the functioning of the new three-tier appeal system. Since the appellate courts have only recently started to work and grant decisions, there is no established procedure for examination proceedings (e.g. expert examinations). We will discover procedural practice of the appellate courts in the following months.In addition, we expect Regulations on the Implementation of the IPL to be published as there are many issues which are yet to be decided.

8.3 Are there any general practice or enforcement trends that have become apparent in your jurisdiction over the last year or so?

Very recently, in a patent invalidation action where the IP Court decided not to wait for the EPO proceedings and decided to render its final decision, as a last attempt to save the patent, the patent owner filed an application for the limitation of the claim set under Article 138/3 of the EPC. Limitation was based on the claim as allowed by the Opposition Division.Surprisingly, but fairly, the court and the Institute accepted the claim limitation request of the patent holder. It was important to emphasise to the court that the claim set has become identical to the limited set of claims before the EPO.This may lead us to a new era where there is a parallel between EPC and Turkish patent legislation and also the procedures to obtain a patent will complete each other, resulting in consistency between the claims of Turkish and referred European patents.The recent decision of the IP Court and the Institute may also reduce the number of invalidation cases and save patent holders in the same situation from the invalidation of their patents by limiting the claims of the patent before EPO proceedings have been finalised or, more importantly, after they have been finalised.

Where only partial rights to the patent are claimed, a court action may be filed claiming joint ownership of the patent.The right to raise such a claim and file such a court action as described above shall be exercised within two years following the date of publication of the patent or, in cases of bad faith, until the expiry of the term of protection of the patent.At the request of the interested party, the court action and the claims put forward therein, the final ruling or any other action concluding the court action shall be registered in the Patent Register in order to have effect against third parties.

5.6 Is there a “grace period” in your jurisdiction, and if so, how long is it?

The IPL defines a priority period of 12 months in Article 93. Accordingly: “Any person or his successor who has duly filed an

application for a patent or utility model in any state that is party to the Paris Convention or the Treaty Establishing the World Trade Organization, including Turkey, may benefit from the priority right within a period of twelve months as of the date on which the first application is filed for the purpose of submitting an application for the same invention in Turkey.

Real persons or legal entities who display the product comprising the subject of the patent or the utility model in the national or international exhibitions held in Turkey or in official international exhibitions or those regarded as official held in the countries party to the Paris Convention may benefit from the priority right on filing an application for receiving a patent or utility model in Turkey within twelve months as of the date of display in the relevant exhibition.”

5.7 What is the term of a patent?

The term of a patent is 20 years from the date of filing the application. It cannot be extended. (Article 101 of the IPL.)

6 Border Control Measures

6.1 Is there any mechanism for seizing or preventing the importation of infringing products, and if so, how quickly are such measures resolved?

Yes, a patent owner may apply to the Customs Office to seize or prevent the importation of infringing products. Such applications are very common but, in practice, not easy to enforce, because Customs staff are more familiar with trademark-related matters and it is difficult for them to understand and detect patent infringement.

7 Antitrust Law and Inequitable Conduct

7.1 Can antitrust law be deployed to prevent relief for patent infringement being granted?

IP courts do not handle antitrust law-related arguments. Interested parties may deploy antitrust law before the Turkish Competition Authority, or claim a damages action based on the Competition Act before commercial courts.

Gün + Partners Turkey

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ey

Selin Sinem ErciyasGün + PartnersKore Sehitleri Cad. No. 1734394 ZincirlikuyuIstanbulTurkey

Tel: +90 212 354 0000Email: [email protected]: www.gun.av.tr

Tuğçe Avcısert GeçgilGün + PartnersKore Sehitleri Cad. No. 1734394 ZincirlikuyuIstanbulTurkey

Tel: +90 212 354 0000Email: [email protected]: www.gun.av.tr

Gün + Partners is a full-service institutional law firm with a strategic international vision, providing transactional, advisory and dispute resolution services.

It is one of the oldest and largest law firms in Turkey, and is internationally recognised among the top-tier legal service providers in the country. The firm is based in Istanbul, with working and correspondent offices in Ankara, İzmir and the major commercial centres in Turkey. The firm advises a large portfolio of clients in numerous fields of activity, including life sciences, energy, construction & real estate, logistics, technology, media and telecoms, automotive, FMCG, chemicals and the defence industries. Lawyers in the firm are fluent in Turkish and English and also work in German, French and Russian.

The firm is ranked among the top-tier legal service providers in Turkey by international legal directories for a period surpassing 10 years, including being consistently ranked as the leading IP practice firm. Senior associates and partners in the firm are recommended as key individuals in their respective fields of expertise.

Selin is a partner in the Intellectual Property Department, specialising in IPL and Life Sciences issues. Selin has been involved in a number of advisory and litigation matters in all fields of IP, and has handled hundreds of both contentious and non-contentious administrative oppositions, and court actions involving patents and trademarks. Selin has been involved in a number of patent infringement actions, declaration of non-infringement actions and nullity actions.

She represents a number of multinational pharmaceutical companies before the Ministry of Health in relation to regulatory issues and assists pharmaceutical companies in regulatory examinations before the MOH.

Selin also served as a counsel to the Association of Research-Based Pharmaceutical Companies (“AIFD”). She represented the AIFD at the commission meetings of the Turkish Parliament on the draft IPL in Turkey.

Selin is a graduate of Ankara University and holds an LL.M. degree in European and International Commercial Law from Ludwig Maximilian University of Munich.

Tuğçe is a senior associate in the Intellectual Property Department and the Life Sciences working group of Gün + Partners. She has been involved in many trademark and patent law disputes as an IP litigator, and represented clients in numerous patent infringement, invalidation and declaratory of non-infringement actions.

She advises corporate clients from the life sciences sector, especially multinational pharmaceutical and medical device companies, the Association of Research-Based Pharmaceutical Companies (“AIFD”) in Turkey. In her regulatory practice, she advises and represents her clients on a wide range of issues including clinical trials, marketing authorisation procedures, pricing and reimbursement regulations, and promotion practices. She assists clients in their day to day business activities; indeed she provided secondment to a global pharmaceutical company lately.

Tuğçe graduated from Österreichisches St. Georgs-Kolleg, Istanbul in 2006 and Koç University, Faculty of Law in 2011 with a “dean’s honor” degree.

Gün + Partners Turkey

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Chapter 29

Gorodissky & Partners (Ukraine)

Ukraine

For example, in the case of monetary claims, the court fees to be paid for filing the claim with the economic court depend on the amount in dispute under the claim, and they are calculated based on the rate of 1.5% of the amount in dispute but reaching at least 1 minimum subsistence amount (approx. EUR 55) and not exceeding 150 times the minimum subsistence amount (approx. EUR 8,300 depending on the official currency rate).Additional court fees are paid when applying for injunctions, submitting an appeal or second appeal, and for certain other actions related to court proceedings.

1.3 Can a party be compelled to disclose relevant documents or materials to its adversary either before or after commencing proceedings, and if so, how?

The relevant documents or materials should be disclosed by sending the claim, along with all attachments, to the adversary:(i) before commencing proceedings in the economic court; and(ii) after commencing proceedings in the general court.Also, an interested party may request the relevant (additional) documents or materials to be disclosed after commencement of the proceedings. If such a party substantiates its request by the circumstances to be proved or established by such disclosure, the court may issue an order to disclose the necessary documents or materials to the opposing party.

1.4 What are the steps each party must take pre-trial? Is any technical evidence produced, and if so, how?

The law does not provide for any mandatory pre-trial stages in patent-related litigation.At the pre-trial stage, the parties may try to resolve the dispute amicably by sending a cease-and-desist letter to its adversary. If the dispute was not resolved amicably, the interested party may file a claim with the court to initiate proceedings on a case.The statement of claim shall contain the remedy sought, circumstances on which the statement of claim is grounded, details of the available evidence, a substantiated calculation of damages (if claimed), and any necessary attachments.The adversary may present its own statement of defence containing arguments against the claim and evidence to prove the arguments. Each of the parties may file expert opinions to be considered by the court as evidence in the case.

1 Patent Enforcement

1.1 Before what tribunals can a patent be enforced against an infringer? Is there a choice between tribunals and what would influence a claimant’s choice?

In Ukraine, patents can be enforced in general courts and economic courts. The choice of court (general or economic court) depends on the parties in dispute; namely, on whether the parties are legal entities or individuals. Disputes between individuals or between the parties with at least one party-individual are subject to consideration by the general courts. Disputes in which all parties are legal entities are subject to economic courts.

1.2 What has to be done to commence proceedings, what court fees have to be paid and how long does it generally take for proceedings to reach trial from commencement?

Under Ukrainian procedural legislation, there is no obligation to approach the infringer by the sending of a warning or a cease-and-desist letter within the so-called pre-trial procedure stage before commencement of the proceedings. In order to commence proceedings before the economic court, the claimant shall send the statement of claim to the parties in dispute, third parties and court, whereupon the judge commences proceedings on the case within a term of three days after the day of the filing of the statement of claim by sending its ruling to the parties. As a rule, the judge schedules the first hearing within two or three weeks after commencement of the proceedings. In order to initiate proceedings before the general court, the claimant shall file its claim, along with copies of the statement of claim (according to the number of the parties and third parties), with the court. It is the duty of the court to send the copies of the claim to the parties with the ruling on the commencement of the proceedings enclosed. The ruling shall be issued within three days after a statement of claim is filed with the court. Preliminary hearings may also be appointed in civil cases. As a rule, the judge schedules the first hearing within two or three weeks after commencement of the proceedings.The amount of court fees for submitting the claim to the court depends on the nature and amount of stated claims, as well as the competent court (general or economic court). The court fees are paid for each stated claim.

Nina Moshynska

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be a patent owner or a licensee, provided that it has the licensor’s consent to sue for infringement. In patent revocation proceedings, the plaintiff has to prove infringement or inhibition of its rights or legitimate interest by the patent.As regards declaratory proceedings, the procedural laws of Ukraine limit such types of proceedings to certain types of cases. Thus, the related case law is limited to a smaller number of judgments.

1.10 If declarations are available, can they address (i) non-infringement, and/or (ii) claim coverage over a technical standard or hypothetical activity?

According to the procedural laws of Ukraine, declaratory proceedings are available in a limited number of cases. Declaratory judgments that address non-infringement claim coverage over a technical standard or hypothetical activity are not practised in Ukraine.It is nevertheless possible to initiate a court proceeding and establish certain legal facts in the course of it. In cases where such legal facts are mentioned in the court judgment, it can be further referred to for the purpose of any other legal actions, claims, etc., in the future. In the area of patent law, such practice is not well-developed in Ukraine.

1.11 Can a party be liable for infringement as a secondary (as opposed to primary) infringer? Can a party infringe by supplying part of, but not all of, the infringing product or process?

In Ukraine, there is no doctrine of contributory infringement. Therefore, primary and secondary infringement as specific types of patent infringement are not determined in Ukrainian legislation. The patent owner or his authorised licensee, however, have the right to prevent third parties from carrying out acts that relate to the treatment of patent infringement.A party shall be liable for patent infringement in cases where it is proved that:■ the supplied part of a product contains the unauthorised use

of a patent; or■ the party intentionally participates in infringing activities in

a group with the other infringers and the relations between them, as well as their joint infringing activities, can be confirmed by sufficient evidence.

1.12 Can a party be liable for infringement of a process patent by importing the product when the process is carried on outside the jurisdiction?

According to the law, the use of a patented invention includes the following actions: ■ manufacturing of a product with the use of a patented

invention/utility model, applying such a product, offering it for sale (including Internet sales), selling, import, and otherwise introducing it on the market, or storage of such a product with the purposes previously specified; and

■ applying the process protected by the patent, or offering its application within the territory of Ukraine, provided that the person offering the application of the process knows that its unauthorised use would be an infringement, or if it is obvious that the unauthorised application of the process would constitute an infringement.

Further, the law prescribes that a product is considered to be manufactured through the use of a patented process, unless the

1.5 How are arguments and evidence presented at the trial? Can a party change its pleaded arguments before and/or at trial?

The parties may present the arguments and evidence by filing them with the court in written or verbal form.Unlike the economic courts, the civil courts also take witnesses’ evidence.The parties may file written expert reports as evidence in the case. However, if technical issues are to be examined, the court may require the opinion of the certified expert(s). The parties to a civil case shall present their proofs before examining the merits of the case. The proofs presented thereafter shall not be reviewed by the court.In both civil and commercial proceedings, the claimant may change relief sought or cause of action before the stage which involves ‘examining the merits of the case’ by the court.

1.6 How long does the trial generally last and how long is it before a judgment is made available?

In civil cases, the court trial generally lasts no more than two months from the date of the commencement of the proceedings, and in commercial cases, no more than two months from the date of the filing of the claim with the court. However, these terms can be extended.In fact, consideration of patent-related cases lasts from two months up to several years, due to the necessity of expert examination of the specific technical issues on the case.The court renders a decision on the case at the last hearing, when consideration of the case is finished. The full text of the court’s decision shall be available within three days of the date of the passing of the decision in commercial cases, and within two days in civil cases.

1.7 Are judgments made available to the public? If not as a matter of course, can third parties request copies of the judgment?

According to the Law of Ukraine “About access to judgments”, all judgments are open and are subject to promulgation electronically no later than the next day after their rendering and signing the full text thereof. Third parties can request copies of the judgment in case the judgment directly addresses their rights, freedoms, interests or obligations.

1.8 Are there specialist judges or hearing officers, and if so, do they have a technical background?

Ukrainian court staff are not represented by special judges, hearing officers or any other specialists having a technical background for patent litigation cases. At the same time, there are judges with particular expertise and experience in intellectual property in every court. As regards the technical knowledge required in the course of the court proceedings, the judge appoints the relevant expert(s) to conduct the examination of specific technical issues.

1.9 What interest must a party have to bring (i) infringement, (ii) revocation, and (iii) declaratory proceedings?

According to the procedural laws of Ukraine, the plaintiff shall

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1.17 What other grounds of defence can be raised in addition to non-infringement or invalidity?

The persons accused in infringement of a patent can raise the following defences: ■ to prove that their activities do not constitute patent

infringement on the basis of the relevant law; ■ to prove that the use of a patented invention/utility model is

made upon authorisation of the patent owner or other person authorised by the patent owner (i.e., the licensee etc.);

■ a parallel claim for compulsory licensing;■ to prove that the use of invention/utility model falls within

the exceptions prescribed by the law. Namely, the exceptions include the following: ■ the right of prior use;■ use for scientific/research purpose; ■ non-commercial use;■ use in vehicle construction (including cargo, marine

vehicles and aircraft), provided that the vehicle is registered in a foreign state and the invention/utility model is used exclusively for the purpose of the vehicle’s operation; and

■ use under force majeure circumstances, subject to notification of the patent owner as soon as it becomes possible and subject to later payment of remuneration for the use of a patent.

1.18 Are (i) preliminary, and (ii) final injunctions available, and if so, on what basis in each case? Is there a requirement for a bond?

Ukrainian legislation does not prescribe final injunctions, only preliminary. Permanent injunctions can be granted by final decision of the court as an order to do or cease from doing certain activities.Preliminary injunctions are applicable if rejection of the respective measures against the infringer can make further enforcement of judgment impossible or difficult and/or if there is a risk that the evidence in the case will not be preserved. The injunctions may be applied by the court upon the plaintiff’s solicitation prior to, or immediately after, submission of the claim. Allowing the injunctions, the court may require a bond sufficient to prevent abuse of the claim injunctions that shall be paid in a court deposit account. The bond shall be determined by the court with respect to the circumstances of the case, but should not be higher than the amount of the claim price.

1.19 On what basis are damages or an account of profits assessed?

According to the laws of Ukraine, the patent owner can claim actual damages (losses caused by the infringement) and expenses necessary to reinstate the preexisting state caused by the infringement of rights to a patent, including the lost profit. The amount of damages claimed should be supported by the relevant evidence (documents and calculations, which the patent owner should provide). The court examines the evidence provided, and estimates the amount of damages based on criteria such as the character and scope of infringement, the profits that the patent holder could have gained from the use of the patent, and others.

contrary is proved, in the case that at least one of the following conditions applies:■ a product manufactured with the use of the patented process

is new; and/or■ there are grounds to believe that the product is manufactured

with the use of the patented process and the patent owner cannot identify a process that has been used for manufacturing of the product by way of reasonable efforts.

In case at least one of the said conditions applies, the obligation to prove non-use of the patented process concerning the manufactured product lies with the person accused of infringement of rights to the patent. Considering the above, the importation of a product made with the use of the patented process may be considered infringement of a patent.

1.13 Does the scope of protection of a patent claim extend to non-literal equivalents?

The use of each feature of an independent claim or its equivalent shall be considered infringement. Therefore, the scope of patent protection can be significantly extended by the proper application of the doctrine of equivalents and by providing arguments and evidences supporting a proposed equivalent.

1.14 Can a defence of patent invalidity be raised, and if so, how? Are there restrictions on such a defence e.g. where there is a pending opposition?

Yes, a defence of patent invalidity can be raised during the patent invalidity proceedings before the court. In the court proceedings, the parties are entitled to provide evidence in support of their claims or statements of defence. The patent owner can assert that there are no legal grounds for invalidation of the disputed patent and provide relevant evidence of this.

1.15 Other than lack of novelty and inventive step, what are the grounds for invalidity of a patent?

A patent may be invalidated in whole or in part during the course of its term of validity in cases where:(a) the patented object does not meet the patentability conditions

specified by the law (industrial applicability, novelty and inventive step);

(b) invention claims contain features which were not included in the filed patent application;

(c) a patent application has been filed by a Ukrainian resident abroad without filing a first application with the Ukrainian Patent and Trade Mark Office (UA PTO); or

(d) the patent was granted as a result of third party rights infringement during the filing of the application.

1.16 Are infringement proceedings stayed pending resolution of validity in another court or the Patent Office?

In case the patent invalidation claim is filed in the course of court proceedings related to patent infringement, the infringement proceeding shall stay pending until the decision is passed to confirm the validity of a patent. In Ukraine, claims concerning patent validity may only be raised before the courts.

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aware or should have become aware of the fact of infringement of its rights.

1.24 Is there a right of appeal from a first instance judgment, and if so, is it a right to contest all aspects of the judgment?

First instance judgments can be appealed to the court of appeal with respect to all aspects of the judgment (i.e. its non-conformity with material and/or procedural laws, wrong or incomplete estimation of all merits of the case, etc.). The appeal judgment can be further appealed to the court of cassation, but only on the ground of infringement of material/procedural laws. In certain cases, the revision of judgments passed by the first instance, appeal and cassation courts can be made by the Supreme Court of Ukraine. The solicitation to the Supreme Court can be filed after the judgment of the cassation court is passed.

1.25 What are the typical costs of proceedings to first instance judgment on (i) infringement, and (ii) validity? How much of such costs are recoverable from the losing party?

The amount of court fees for submitting a civil claim depends on the nature and amount of stated claims, as well as the competent court (general jurisdiction court or commercial court). The court fees are paid for each stated claim. In the case of monetary claims, the court fees amount to 1% or 1.5% from the claimed amount of damages. Additional court fees are paid in the case of applications for injunctions, submitting an appeal or a second appeal, and certain other actions related to the court proceedings.All such costs are recoverable from the losing party.

1.26 For jurisdictions within the European Union: What steps are being taken in your jurisdiction towards ratifying the Agreement on a Unified Patent Court, implementing the Unitary Patent Regulation (EU Regulation No. 1257/2012) and preparing for the unitary patent package? For jurisdictions outside of the European Union: Are there any mutual recognition of judgments arrangements relating to patents, whether formal or informal, that apply in your jurisdiction?

In Ukraine there are no particular judgment arrangements as regards the recognition of foreign judgments related to patents.In general, foreign court judgments can be recognised and/or enforced on the ground of agreements concluded between the related countries; otherwise, they can be recognised based on reciprocity principle. As regards the recognition of certain facts that have been established by the decision of a foreign court, Ukrainian courts are not obligated to recognise such facts. In such a case, a foreign judgment may be filed by a party as evidence in a case; however, it will not prevail with respect to other evidence.

The amount of “lost profit”, when determined by the court, may not be lower than the profit gained by the infringer in the course of unauthorised use of the patent.

1.20 How are orders of the court enforced (whether they be for an injunction, an award of damages or for any other relief)?

The court may order injunctions to be imposed at any stage of the review of the case. Such injunctions are imposed if rejection of the respective measures against the infringer could make further enforcement of judgment impossible or difficult, and/or if there is a risk that the evidence in the case will not be preserved.The injunctions may be applied by the court upon the plaintiff’s solicitation prior to, or immediately after, submission of the claim. According to the laws of Ukraine, the patent owner can claim actual damages (losses caused by the infringement) and expenses necessary to reinstate the preexisting state caused by the infringement of rights to a patent, including the lost profit. The amount of damages claimed should be supported by the relevant evidence (documents and calculations, which the patent owner should provide).Based on the grounded claims of the patent owner and after review of the case, the court may render a decision obligating the plaintiff to pay indemnity for property, including lost profits and moral damages, as well as to terminate IP infringement, and obligating the respective authorities (for instance, the State Executive Service of Ukraine, UA PTO, etc.) to further enforce such decision.

1.21 What other form of relief can be obtained for patent infringement? Would the tribunal consider granting cross-border relief?

According to the laws of Ukraine, the patent owner can take the following actions in the case of patent infringement: ■ Request applying the measures for preventing any further

infringements and/or securing the evidence. ■ Claim damages. ■ Request suspension of the infringing goods/products on the

border. ■ Request confiscation of the goods/products introduced on the

market with the infringement of rights to the patent. ■ Request publication in the official printed media of the fact of

infringement and of the court decision. ■ Make other requests or claims at the discretion of the patent

owner. The courts of Ukraine do not consider granting cross-border relief, since Ukrainian legislation should apply only in the territory of Ukraine.

1.22 How common is settlement of infringement proceedings prior to trial?

In our experience, settlement of infringement proceedings prior to trial takes place in up to 40% of cases.

1.23 After what period is a claim for patent infringement time-barred?

The period in which the civil action can be commenced is three years. It is calculated from the date on which the person became

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3.2 Can a patent be the subject of a compulsory licence, and if so, how are the terms settled and how common is this type of licence?

The law provides for cases where a compulsory licenсe can be obtained.If an invention (utility model) is not used or is used insufficiently in Ukraine within three years from the date of publication of the information on the grant of patent or from the date on which the use of invention (utility model) has been discontinued, then any person who wishes and is ready to use an invention (utility model) may file a claim with the court to grant permission to use the invention (utility model). In case the patent owner does not prove that the non-use of the patented invention (utility model) is caused by serious grounds, the court renders a decision to grant a compulsory licence to the interested party. In the decision, the court determines the scope of a licence, its validity term, the terms of payment and other conditions. Also, the patent owner shall give permission (licence) to use an invention (utility model) to the owner of the later granted patent if an invention (utility model) of the latter is designed for achievement of another goal or has significant technical and economic advantages and cannot be used without violation of owners’ rights to the previously granted patent.In order to ensure health, state defence, environmental safety and other public interests, the Cabinet Ministers of Ukraine may permit the use of a patented invention (utility model) to the person defined by it without consent of the patent (declarative patent) owner in the case of its unreasonable refusal to grant licence to use the invention (utility model). However, compulsory licensing is not common in Ukraine.

4 Patent Term Extension

4.1 Can the term of a patent be extended, and if so, (i) on what grounds, and (ii) for how long?

The term of a patent related to drugs, means for the protection of animals, and means for the protection of plants (use of which requires the permission of the governmental institutions) may be extended at the request of the owner for a period that is equal to the period between the date of the filing of the application and the date of the receipt of such a permission, but for no longer than five years.

5 Patent Prosecution and Opposition

5.1 Are all types of subject matter patentable, and if not, what types are excluded?

The following are not patentable as inventions (utility models): plant varieties and animal breeds; biological processes of reproduction of plants and animals that do not belong to the non-biological and microbiological processes; topographies of integrated circuits; results of artistic design; discoveries, scientific theories and mathematical methods; methods of intellectual, economic, organisational and business activity (planning, financing, procurement, accounting, credit, forecasting, valuation, etc.); rules for physical exercise, games, contests and auctions; projects and schemes of planning structures, buildings, and territories; symbols (road signs, routes, codes, fonts, etc.), schedules and instructions; computer software; and presentation of information (e.g. in the form of tables, charts, graphics, use of

2 Patent Amendment

2.1 Can a patent be amended ex parte after grant, and if so, how?

The mistakes in patents may be corrected by the filing of a motivated request to the UA PTO. The patent may be amended after grant by limitation of the scope of protection. An appropriate request shall be filed with the UA PTO.

2.2 Can a patent be amended in inter partes revocation/invalidity proceedings?

The law does not determine special procedures in such cases. Amendments which are directed towards the limitation of the scope of protection shall be filed with the UA PTO through an appropriate request.

2.3 Are there any constraints upon the amendments that may be made?

In practice, independent or dependent claims may be excluded in order to limit the scope of protection. The addition or exclusion of features requires the filing of special conclusions on patentability of amended claims. At the same time, the re-examination procedure is not available, which complicates such amendments.

3 Licensing

3.1 Are there any laws which limit the terms upon which parties may agree a patent licence?

The parties are free to choose the terms of the patent licence, but according to the laws of Ukraine, there are a number of terms which should be determined by the parties in the patent licence agreement. These include rights granted under the agreement, territory (unless the territory is specified, it shall be regarded as Ukraine), type of licence (unless the type of licence is specified, it shall be regarded as non-exclusive), and terms of licence (unless the term is specified, the agreement shall be regarded as concluded for the term of validity of the patent, but for no longer than five years). The patent licensing agreement cannot be executed in respect of the patent rights which are not in force at the time of the execution of the agreement.The licence agreement is not subject to obligatory registration in Ukraine. Parties to the agreement have the right to register the licence in the State Register of Inventions.The following clauses are obligatory and should be included in the licence agreement in order to be registered:■ parties to the licence agreement;■ subject matter of the licence agreement;■ patent number;■ title of the invention;■ scope of granted rights under the licence;■ type of licence (exclusive or non-exclusive);■ term of the licence agreement;■ territory of the licence agreement; and■ addresses of the parties to the licence agreement.A patent licence agreement shall be made in writing.

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Upon entry of the patented invention/utility model in the Customs Registry, the customs officers control import and export of the goods with the use of the patented IP object. Upon revealing any suspected goods, the customs officer suspends the shipment for 10 working days and notifies the patent owner thereof. Upon receipt of such a notification, within the specified 10-day period, the patent owner is entitled to obtain detailed information on the suspended goods, inspect them and take their samples in order to determine whether the goods are authorised or infringing.

7 Antitrust Law and Inequitable Conduct

7.1 Can antitrust law be deployed to prevent relief for patent infringement being granted?

Antitrust law in Ukraine does not contain provisions on the prevention of relief for patent infringement being granted.

7.2 What limitations are put on patent licensing due to antitrust law?

Antitrust law in Ukraine does not contain direct provisions on patent licensing.

8 Current Developments

8.1 What have been the significant developments in relation to patents in the last year?

On 5 February 2016, the state enterprise “Ukrainian Institute of Intellectual Property” (Ukrpatent) began operating as the International Searching and Preliminary Examination Authority (ISA/IPEA) under the Patent Cooperation Treaty (PCT), in addition to an authority designated for carrying out supplementary searches. The results of Ukrpatent’s first international search were sent to the applicant as well as to the International Bureau of the World Intellectual Property Organization (WIPO) at the beginning of June, 2016. Meanwhile, certain developments regarding case law are worth mentioning. According to the established case law, disputes in connection to patent infringements or other disputes as regards the use of patented inventions/utility models, are considered by the courts, with the involvement of judicial experts – the specialist having the relevant technical background. The judicial experts’ conclusions serve as evidence in the course of decision-making. Nevertheless, since 2016 a number of the decisions have been made by the judges without the involvement of judicial experts. Namely, in case No. 457/173/16-c, the Truskavetskyy city court established that the fact of unauthorised use of a patented utility model can be established based on obvious facts and available evidence. Further, in case No. 761/1551/16-c, the Shevchenkivskyy district court of Kiev established patent infringement based on the available evidence and evidence gathered in similar cases recently considered by the same court, between the same parties. Thus, in certain cases the Ukrainian courts are starting to avoid unnecessary cost and time complications in patent litigation, as prescribed by the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement). However, in most cases the courts continue to appoint a judicial expert, on the ground that the judges do not have the necessary knowledge to consider the fact of patent infringement or use of a patented solution.

acoustic signals, pronunciation of words, visual demonstrations, books, and audio and video discs).

5.2 Is there a duty to the Patent Office to disclose prejudicial prior disclosures or documents? If so, what are the consequences of failure to comply with the duty?

The UA PTO may disclose published information only.

5.3 May the grant of a patent by the Patent Office be opposed by a third party, and if so, when can this be done?

An opposition procedure is not available in Ukraine. However, before a decision to grant, a third party may supply additional arguments or bring additional “state of the art” documents to the attention of the UA PTO. There are known cases where a communication from a third party has precluded granting, although the UA PTO is not obliged to take such communications into account.

5.4 Is there a right of appeal from a decision of the Patent Office, and if so, to whom?

The applicant may file an appeal from a decision of the UA PTO with the Chamber of Appeals of the UA PTO or with the court.

5.5 How are disputes over entitlement to priority and ownership of the invention resolved?

Disputes over entitlement to priority and ownership of the invention are resolved in court.If an invention/utility model has been created by two or more inventors independently, the right to a patent belongs to the applicant whose application has the earliest filing date or, if priority is claimed, the earliest priority date, provided that the application is not considered withdrawn, is not withdrawn, or there is a decision on refusal to grant patents under this application.

5.6 Is there a “grace period” in your jurisdiction, and if so, how long is it?

The grace period for novelty is 12 months prior to the filing date (or priority date if claimed) of a patent application with the UA PTO.

5.7 What is the term of a patent?

The term of a patent is 20 years for inventions and 10 years for utility models.

6 Border Control Measures

6.1 Is there any mechanism for seizing or preventing the importation of infringing products, and if so, how quickly are such measures resolved?

The control of the importation/exportation of infringing goods is carried out by means of the Customs Registry of Intellectual Property Objects (hereinafter, the “Customs Registry”).

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Registry on the following ground: in order to determine the use of the patented decision, it is necessary to examine the various stages of the use of an item of goods. Such examination is not possible in the course of customs clearance procedures that are performed within the customs control area.The above-mentioned decision may have considerable influence as regards the protection of IP rights to patented decisions at the customs border. Based on the said decision, customs may be provided with a legal ground to refuse entry of the patented solution in the Customs IP Registry in case its use cannot be determined by customs during the customs clearance of the goods.

8.2 Are there any significant developments expected in the next year?

On 1 June 2016, the Cabinet of Ministers of Ukraine adopted the “Concept for reforming the intellectual property system” which, among other things, envisages the creation of a National Agency for Intellectual Property and the adoption of changes to IP laws during the course of 2016–2017. The said reorganisation of the Ukrainian intellectual property system is currently in progress.On 3 June 2016, the Parliament of Ukraine adopted a law on reforming the judicial system of Ukraine. The reform provides for establishing a High Court on Intellectual Property Issues by autumn 2017 as a court of first instance for copyright, trade mark and patent disputes. Judicial decisions will be reviewed in the specialised Court of appeal, within the chamber of the Supreme Court of Ukraine. Such judicial reform is currently in progress.

8.3 Are there any general practice or enforcement trends that have become apparent in your jurisdiction over the last year or so?

Among the new enforcement trends that have become apparent within the last year, are those related to the entry of patented inventions/utility models in the Ukrainian Customs Registry of Intellectual Property Objects (hereafter the Customs Registry). Based on the laws of Ukraine, any patented invention/utility model can be entered in the Customs Registry. Upon such entry, the customs shall control the use of the invention/utility model in the goods declared for import or export. In practice, the customs face difficulties in controlling the use of the patented technical or technological solution in the imported/exported goods, since the application of the patented decision on such goods cannot always be traced during their visual inspection and/or the checking of their customs documents. Thus, customs have started to refuse the entry of patented solutions in the Customs Registry, in cases where the visual inspection of the goods does not allow them to trace the use or non-use of the patented solutions. The recent case law has supported the noted customs practice. For instance, the Supreme Administrative Court of Ukraine rendered a decision in case No. 826/12570/15 of 21/12/2016, according to which the court supported the refusal to enter the utility model in the Customs

Nina MoshynskaGorodissky & Partners (Ukraine)25, V. Chornovola StrOffice 227Kiev 01135Ukraine

Tel: +380 44 2784 958 / 5011 871Email: [email protected]: www.gorodissky.ua

Nina Moshynska, patent and trade mark attorney, is a founder and a managing partner in Ukraine of Gorodissky & Partners (Ukraine).

Ms. Moshynska has an extensive practice and experience in patent matters, trade mark proceedings and copyright, and also counsels clients on issues related to infringement of intellectual property owners’ rights, licensing and unfair competition. She frequently attends and delivers speeches at IP seminars and conferences in Ukraine and abroad. Ms. Moshynska is a founder, the first President and a member of the Ukrainian Association of Patent Attorneys, and a member of the Ukrainian Chamber of Commerce and Industry, the International Association for the Protection of Intellectual Property, the International Trademark Association, the Licensing Executives Society International, the Association of European Trade Mark Owners and the AEA International Lawyers Network. For many years her expertise has been highly regarded by recognised annual rankings such as Best Lawyers, the International Who’s Who of Trademark Lawyers, World Trademark Review 1000, The Legal 500, Corporate INTL, Global Law Experts and Leaders in Law. Moreover, IP Stars and WIPR Leaders ranked Ms. Moshynska as one of the best experts in the categories of patent disputes and patent prosecution, and as one of best and most remarkable Ukrainian IP protection professionals.

Gorodissky & Partners (Ukraine) is a full-service intellectual property law firm established in 2000.

The firm has been consistently ranked as one of the best firms in Ukraine in the field of IP rights protection in annual international surveys conducted by Managing Intellectual Property. IP Stars recognised the firm among the leaders in such categories as trade mark contentious and trade mark prosecution. According to the World Trademark Review 1000, it is among the leading Ukrainian firms providing trade mark protection services.

The patent/trade mark attorneys and IP lawyers of Gorodissky & Partners (Ukraine) provide a full range of services in the field of intellectual property, including inventions, trade marks, designs, utility models, copyright, computer programs, domain names, litigation, franchising, licensing, etc.

The clients of Gorodissky & Partners (Ukraine) range from major domestic, foreign and international companies to small and medium-sized businesses, as well as individuals.

The patent/trade mark attorneys and IP lawyers of Gorodissky & Partners (Ukraine) are members of the Ukrainian Association of Patent Attorneys, the Ukrainian Chamber of Commerce and Industry, the International Association for the Protection of Intellectual Property, the International Trademark Association, the Licensing Executives Society International, the Association of European Trade Mark Owners and the AEA International Lawyers Network.

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1.3 Can a party be compelled to disclose relevant documents or materials to its adversary either before or after commencing proceedings, and if so, how?

This is not generally a feature of litigation in the UAE. However, in limited circumstances an order may be issued to seize evidence prior to trial. An interim ‘conservatory measures’ order may be sought before filing of the main claim. The purpose of such orders is to search and attach infringing goods, or equipment used to produce infringing goods, etc. for preservation before trial.

1.4 What are the steps each party must take pre-trial? Is any technical evidence produced, and if so, how?

Evidence will be presented during the trial (which takes place as a series of hearings over the course of 12 to 18 months).

1.5 How are arguments and evidence presented at the trial? Can a party change its pleaded arguments before and/or at trial?

Civil trials are conducted on the basis of exchange of written memoranda and documentary evidence. In rare circumstances, the Court may call oral witnesses. The Court will also appoint an expert, who will consider the arguments and evidence presented and will meet with the parties. The expert then prepares and submits a report to the Court. The Court is not bound by the expert’s findings and both parties may also submit further memoranda addressing the findings of the expert. The parties may also seek leave from the Court to each appoint their own further experts.Further arguments may be raised at any time in first instance proceedings. In the event of further arguments, the other party would be given the chance to respond.In the event of a criminal prosecution for patent infringement, oral witnesses may be called by the Prosecutor.

1.6 How long does the trial generally last and how long is it before a judgment is made available?

First instance proceedings generally take 12 to 18 months to complete but can be longer, particularly if the expert delays submission of his/her report or if the parties seek to appoint further experts. Judgments are rendered orally. The written judgment is usually available about one to two weeks after the oral judgment. Appeal periods are calculated from the date of the oral judgment.

1 Patent Enforcement

1.1 Before what tribunals can a patent be enforced against an infringer? Is there a choice between tribunals and what would influence a claimant’s choice?

The UAE has no administrative authority with jurisdiction to enforce patents.The UAE is a federation of seven Emirates – Abu Dhabi, Dubai, Sharjah, Ajman, Ras Al Khaimah, Umm Al Qwain and Fujairah. Of these seven Emirates, three have their own Court systems, namely Abu Dhabi, Dubai and Ras Al Khaimah. Therefore, an infringement occurring in these Emirates should be brought before the Courts of these Emirates. An infringement occurring in one of the other four Emirates should be brought before the Federal Courts of the UAE. The Emirate of Dubai has a further Court system – the common law and English language Courts of the Dubai International Financial Centre (‘DIFC’). The DIFC may hear any dispute where the parties agree to its jurisdiction. It is unlikely that an infringer would agree; however, in the event of two large multi-national companies being involved in a patent infringement dispute in the UAE, they may agree to take the dispute to this Court. We believe this would be a remote scenario at this time.

1.2 What has to be done to commence proceedings, what court fees have to be paid and how long does it generally take for proceedings to reach trial from commencement?

An interim ‘conservatory measures’ order may be sought before filing of the main claim. The purpose of such orders is to search and attach infringing goods/equipment used to produce infringing goods, etc. for preservation before trial.There are no pre-trial procedures. Once the claim is filed and the Court fee paid, the Court will assign the first hearing date and summon the parties. This will normally be within one month of the claim being filed. The Court fee is calculated based on the value of the claim. Expert fees are paid to the Court separately and at a later stage of the case.It is common for the defendant not to appear at the first hearing, and several adjournments may be granted in order for the defendant to appoint an advocate to appear on its behalf.

Sara Holder

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1.14 Can a defence of patent invalidity be raised, and if so, how? Are there restrictions on such a defence e.g. where there is a pending opposition?

This is not expressly provided in the legislation. Technically, raising such a defence would raise jurisdictional issues. Patents are federally granted rights. If infringement proceedings were brought in the Courts in Dubai, for instance, and invalidity was raised as a defence, then a Dubai Court would decide on validity of right that has effect across all seven Emirates.Generally speaking, a counterclaim for invalidity should be filed before the Federal Courts and a stay in infringement proceedings may be issued.

1.15 Other than lack of novelty and inventive step, what are the grounds for invalidity of a patent?

The Patent Law does not set out defined grounds and therefore, on a broad interpretation, it may be possible to argue additional grounds such as misappropriation.

1.16 Are infringement proceedings stayed pending resolution of validity in another court or the Patent Office?

It may be considered by the Court determining the infringement.

1.17 What other grounds of defence can be raised in addition to non-infringement or invalidity?

Other grounds of defence include acts carried out for non-commercial purposes (such as academic research), temporary introduction by transport means, and good faith prior use.

1.18 Are (i) preliminary, and (ii) final injunctions available, and if so, on what basis in each case? Is there a requirement for a bond?

Conservatory measures orders are the interim orders available under the Patent Law. An asset attachment order to freeze assets/funds may generally be available in some cases. The Court may order the cessation of “the effects of an activity contravening the law”, which should effectively mean a permanent injunction. However, some commentators believe this would only apply to the infringement at issue in the case, and not to future possible acts of infringement.However, we believe that the law should be read in line with the UAE’s international treaty obligations and allow the granting of effective permanent injunctions.

1.19 On what basis are damages or an account of profits assessed?

Damages or an account of profits are estimated based on evidence placed before the Court. The Court may ask an expert to assist with calculating. As there is no discovery process, there may be difficulty in having real evidence put forth to establish damages or an account of profits. Damages awards do tend to be small (generally in IP cases, there is little jurisprudence for patent litigation) as the Courts do not yet have the experience to consider the issues in depth.

1.7 Are judgments made available to the public? If not as a matter of course, can third parties request copies of the judgment?

Only Court of Cassation judgments are published. Other level judgments cannot be obtained.

1.8 Are there specialist judges or hearing officers, and if so, do they have a technical background?

The Federal Court in Abu Dhabi has recently established an Intellectual Property division to hear intellectual property-related cases. The judges sitting in this division do not have a technical background but have had additional training in intellectual property law, including patents. The Court appoints experts, who may be technical experts, in almost every case.As mentioned in the answer to question 1.1 above, an infringement matter in Dubai, Abu Dhabi or Ras Al Khaimah would need to be brought before the Emirate level courts of those emirates. In the other four Emirates, the Federal Courts in each Emirate have jurisdiction. Accordingly, at this stage, the specialist division outlined above would not hear infringement matters. A revocation suit would go to this division.

1.9 What interest must a party have to bring (i) infringement, (ii) revocation, and (iii) declaratory proceedings?

i) Infringement proceedings: the patentee or a licensee having rights to enforce a patent.

ii) Revocation proceedings: any interested party. This would be interpreted broadly.

iii) Declaratory proceedings: not provided for by the Patent Law.

1.10 If declarations are available, can they address (i) non-infringement, and/or (ii) claim coverage over a technical standard or hypothetical activity?

Declarations are not available.

1.11 Can a party be liable for infringement as a secondary (as opposed to primary) infringer? Can a party infringe by supplying part of, but not all of, the infringing product or process?

Secondary or contributory liability is not expressly provided for in the Patent Law.

1.12 Can a party be liable for infringement of a process patent by importing the product when the process is carried on outside the jurisdiction?

Yes. Patentee rights include the right to prevent importation of products made using the patented process.

1.13 Does the scope of protection of a patent claim extend to non-literal equivalents?

There is no clear jurisprudence at present. We would hope that the new Intellectual Property Division of the Federal Court will provide guidance on this in its decisions.

Rouse & Co. International United Arab Emirates

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1.26 For jurisdictions within the European Union: What steps are being taken in your jurisdiction towards ratifying the Agreement on a Unified Patent Court, implementing the Unitary Patent Regulation (EU Regulation No. 1257/2012) and preparing for the unitary patent package? For jurisdictions outside of the European Union: Are there any mutual recognition of judgments arrangements relating to patents, whether formal or informal, that apply in your jurisdiction?

This is not applicable in the UAE.

2 Patent Amendment

2.1 Can a patent be amended ex parte after grant, and if so, how?

Yes, the patentee may cancel the whole or part of a patent at any time by application to the Patent Office.

2.2 Can a patent be amended in inter partes revocation/invalidity proceedings?

A patentee may apply to amend the patent at the Patent Office and submit these amendments to the Court.

2.3 Are there any constraints upon the amendments that may be made?

Any surrender of part or whole of a patent must not damage the rights of any other person without their specific consent in writing.As mentioned above, in cases of partial cancellation, amendments need to be limited to ‘part of the patent’. This wording likely means that the ‘whole claim’ needs to be removed, rather than being allowed to submit true amendments.

3 Licensing

3.1 Are there any laws which limit the terms upon which parties may agree a patent licence?

The parties generally have freedom to contract in defining the licence terms, including the scope of the licence and the territory. Licences must not exceed the period of protection of the patent and must be in writing. Licences are non-exclusive unless otherwise specifically stated and should be recorded with the Patent Office. The licensee has the right to bring proceedings for infringement of the patent if he notifies the licensor of the infringement and the licensor does not take appropriate actions within 30 days. If the licensee enforces the right, he may also seek compensation from the licensor. Generally, contract laws will govern licences. Excessive penalty interest provisions are generally deemed invalid (under Shari’ah law, interest is not valid).

3.2 Can a patent be the subject of a compulsory licence, and if so, how are the terms settled and how common is this type of licence?

Yes, compulsory licences are available three years after granting of the patent, if the patent has not been worked or worked insufficiently.

1.20 How are orders of the court enforced (whether they be for an injunction, an award of damages or for any other relief)?

The Execution division of the Court will execute the orders.

1.21 What other form of relief can be obtained for patent infringement? Would the tribunal consider granting cross-border relief?

As discussed above, the Court may order the cessation of “the effects of an activity contravening the law”, which should effectively mean a permanent injunction. However, some commentators believe this would only apply to the infringement at issue in the case and not to future possible acts of infringement.However, we believe that the law should be read in line with the UAE’s international treaty obligations and allow the granting of effective permanent injunctions.

1.22 How common is settlement of infringement proceedings prior to trial?

There has been little infringement litigation as yet so no clear trends have emerged. We would suspect that settlement would be preferred in many instances given the Court’s current lack of experience which does bring uncertainty to litigants. Additionally, non-punitive damages orders and no costs orders may also act to encourage settlement.

1.23 After what period is a claim for patent infringement time-barred?

There is a general limitation period of three years from the date of knowledge for acts that cause damage. No limitation period is established under the Patent Law.

1.24 Is there a right of appeal from a first instance judgment, and if so, is it a right to contest all aspects of the judgment?

The Court of First Instance and the Court of Appeal are Courts of fact and law and therefore their judgments may be contested.

1.25 What are the typical costs of proceedings to first instance judgment on (i) infringement, and (ii) validity? How much of such costs are recoverable from the losing party?

Costs awards are generally not available. The losing party will normally have to pay the Court and expert costs. Typical costs of proceedings will vary greatly depending on a number of factors:■ whether a foreign or local firm is appointed to represent you;■ the complexity of the case;■ the number of experts required; and■ the amount of evidence that will need translation to Arabic,

notarisation and legalisation.

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A person who has had their invention misappropriated may seek the transfer of the application/granted patent to themselves through a Court order.

5.6 Is there a “grace period” in your jurisdiction, and if so, how long is it?

There is no grace period available in the UAE.

5.7 What is the term of a patent?

Twenty years from date of filing or deemed date of filing or the international filing date, whichever is earlier.

6 Border Control Measures

6.1 Is there any mechanism for seizing or preventing the importation of infringing products, and if so, how quickly are such measures resolved?

The GCC Customs Law is a unified law relating to Customs matters in the six GCC countries – Bahrain, Kuwait, Qatar, Oman, Saudi Arabia and the United Arab Emirates.The GCC Customs law “prohibits admission, transit or exit of prohibited or infringing goods…”. Goods that violate intellectual property rights are considered “prohibited goods”.Therefore in theory, patent infringements may be stopped at the border, both imported or exported. However, in practice, there is no ex officio action available (this is restricted to trade mark infringements and certain types of copyright infringements at this time) and in order to prevent importation of a patent infringement, a Court order would be required.

7 Antitrust Law and Inequitable Conduct

7.1 Can antitrust law be deployed to prevent relief for patent infringement being granted?

There is no clear guidance on this in the law and no jurisprudence. We would consider the chances remote at this time given the level of experience of the Courts with patent infringement matters.

7.2 What limitations are put on patent licensing due to antitrust law?

There are no specific competition law provisions that directly affect the exploitation of patents. However, the Consumer Protection Law stipulates general provisions for fair competition and combating monopolies. Any contracts or agreements that aim to create or have the impact of creating a prohibited monopoly contravene this law, although this is not known to have been used specifically in relation to the exploitation of patents.The Commercial Transactions Law also covers situations relating to unfair competition and similar activities between traders, which in theory may extend to the misuse of patents.

The prospective licensee must have made reasonable efforts to secure a licence on reasonable commercial terms. Compulsory licences may not be unconditional, must satisfy the needs of the local market, and must grant the patentee fair compensation.An application for a compulsory licence is filed with the Court.

4 Patent Term Extension

4.1 Can the term of a patent be extended, and if so, (i) on what grounds, and (ii) for how long?

Patent extensions are not possible.

5 Patent Prosecution and Opposition

5.1 Are all types of subject matter patentable, and if not, what types are excluded?

The following are excluded from patentability:■ Plant varieties, animal species and biological methods of

producing plants or animals.■ Diagnostic methods, treatments and surgical operations for

humans and animals. ■ Scientific and mathematical principles, discoveries and

methods.■ Guides, rules or methods of conducting business, or

performing mental activities or playing games.■ Inventions that violate public order or morals, or relate to

national defence.

5.2 Is there a duty to the Patent Office to disclose prejudicial prior disclosures or documents? If so, what are the consequences of failure to comply with the duty?

There is no positive duty to disclose such documents. The Patent Office may request anything it considers necessary.

5.3 May the grant of a patent by the Patent Office be opposed by a third party, and if so, when can this be done?

The grant of a patent may be opposed by a third party within 60 days of publication.

5.4 Is there a right of appeal from a decision of the Patent Office, and if so, to whom?

There is an appeal right to the Patent Committee and then from the Patent Committee to the Courts.

5.5 How are disputes over entitlement to priority and ownership of the invention resolved?

If two or more people participate in the creation of the invention, they (or their successors) will share the right to the invention.Where two or more people claim the same invention, the first to file has priority.

Rouse & Co. International United Arab Emirates

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Sara HolderRouse & Co. International11th Floor, The Maze TowerSheikh Zayed RoadP.O.Box 31778DubaiUnited Arab Emirates

Tel: +971 4 309 8000Email: [email protected]: www.rouse.com

Sara Holder currently heads up the MEA practice of global IP firm, Rouse. She holds degrees in law and science (Biochemistry) and qualified and practised in New Zealand as a lawyer before joining Rouse in 1998. Since then, she has worked in China, Indonesia and the Middle East, becoming a specialist in the issues and challenges faced by, and encountered in, developing intellectual property jurisdictions.

In addition to her academic qualifications and experience, Sara is a member of various IP organisations, has published numerous articles in industry journals, contributed to various texts on intellectual property and speaks regularly at seminars and conferences. She is regularly ranked as a leader in her field.

Established in 1990, Rouse is an intellectual property (IP) law firm and consultancy, with offices in 13 countries. We provide the full range of IP services required by our clients to develop, implement and continually revise an IP strategy, from the implementation of global enforcement strategies, to the provision of commercial IP services, and IP acquisition and maintenance services.

Rouse is a market-leading, international IP professional services firm, providing client services at the highest level to leading businesses around the world. We currently represent approximately 1,400 clients managing work in over 180 countries and regional IP groupings. Long-standing clients include many of the world’s foremost IP owners.

8.3 Are there any general practice or enforcement trends that have become apparent in your jurisdiction over the last year or so?

The Government continues to focus on innovation and supporting innovation as an economic driver. Notwithstanding this, patent law and enforcement are still in the early stages in the UAE.

8 Current Developments

8.1 What have been the significant developments in relation to patents in the last year?

A concerted effort to clear the backlog for examination of patent applications filed since 1994 continues. The Korean Patent Office is now co-operating with the UAE Patent Office to assist with examination of these backlogged applications. As reported in last year’s guide, draft amendments to the Patent Law have been prepared and are presently awaiting approval by the UAE Cabinet of Ministers. The establishment of the intellectual property division of the Federal Court (discussed in section 1) is a welcome development.

8.2 Are there any significant developments expected in the next year?

An amendment to the Patent Law is expected with one expected amendment being proper provision for divisional applications. Kuwait’s accession to the Patent Cooperation Treaty (‘PCT’) now opens the way for the GCC Patent Office to consider joining the PCT. A GCC patent gives protection in the UAE, and such accession would be welcomed by applicants.

Rouse & Co. International United Arab Emirates

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there is a fixed fee of £480. However, where a claim for injunctive relief includes a claim for unlimited damages, then the fee is £10,000.The aim of the Patents Court and the IPEC is to bring cases to trial within 12 months of commencement, and steps have been taken to ensure that this target is met.

1.3 Can a party be compelled to disclose relevant documents or materials to its adversary either before or after commencing proceedings, and if so, how?

Yes. Before the Jackson Reforms to civil procedure, each party was required to give “standard disclosure” of documents in its control “relevant” to the issues in dispute. “Relevant” documents are those on which that party relies, those which adversely affect that party’s case, and those which either support or adversely affect the other party’s case. Such standard disclosure is no longer the default position (although it remains an option). Parties must also consider whether alternatives to standard disclosure may be more appropriate, including orders for disclosure only in relation to specific issues or an order dispensing entirely with disclosure. In patent proceedings, “standard disclosure” is modified so as to exclude the following classes of documents: (a) documents that relate to infringement where (in lieu) a product or process description is provided; (b) documents that relate to validity which came into existence more than two years before or after the earliest claimed priority date of the patent; or (c) documents that relate to commercial success. The court may decline to order disclosure, for example where the only issue is obviousness, if it considers such limitation on disclosure to be in accordance with the overriding objective to deal with cases justly and at proportionate cost (Positec Power Tools (Europe) Ltd and others v Husqvarna AB 2016). In the IPEC, a party does not have an automatic right to any disclosure. Instead, disclosure is dealt with at the case management conference on an issue-by-issue basis in accordance with the IPEC’s costs-benefit analysis, balancing the likely probative value of the documents against the cost or difficulty of the search. Disclosure is generally given by serving a list of all relevant documents on the adverse party (claiming legal privilege from production as necessary), and allowing inspection if required of the non-privileged documents (and copies upon request). Confidential documents which are not legally privileged must be listed and produced for inspection, but may be protected by restrictions on disclosure and use by order of the court or agreement of the parties. Pre-action disclosure is possible. For example, in one case, it was ordered in respect of a patentee’s licence agreements, so as to allow

1 Patent Enforcement

1.1 Before what tribunals can a patent be enforced against an infringer? Is there a choice between tribunals and what would influence a claimant’s choice?

There are three jurisdictions within the UK, namely, England and Wales, Northern Ireland, and Scotland. There are no specialist patents courts in Northern Ireland or Scotland, although there are judges, advocates and lawyers with expertise in patents in these jurisdictions. The answers in this chapter address claims in England and Wales only. Patent infringement proceedings may be brought in the Patents Court (a division of the High Court) or the Intellectual Property Enterprise Court (IPEC), both of which are situated in London. The IPEC is intended primarily for smaller or simpler cases – its procedural rules are intended to make it a more accessible forum for small to medium-sized enterprises than the Patents Court. In the IPEC, the total costs recoverable by a successful party are capped at £50,000 for the final determination of liability, and at £25,000 for enquiries as to damages or accounts of profits, and there is a limit of £500,000 on the financial remedies available. Proceedings in both the Patents Court and the IPEC are conducted before specialist patents judges. Infringement claims may, alternatively, be brought in the UK Intellectual Property Office (UKIPO), but only by agreement of the parties. Furthermore, injunctions are not available in the UKIPO; therefore, the jurisdiction is little used.

1.2 What has to be done to commence proceedings, what court fees have to be paid and how long does it generally take for proceedings to reach trial from commencement?

Proceedings are commenced: in the Patents Court by filing with the court a Claim Form with brief Particulars of Claim; and in the IPEC by filing with the court a Claim Form with Particulars of Claim, setting out all the facts and arguments relied upon in a concise manner. Electronic filing became mandatory on 25 April 2017 and it is no longer possible to issue claims, applications or file documents on paper. For infringement actions claiming damages above £10,000, or unspecified damages, the court fee is based on 5% of the value of the claim, subject to a maximum of £10,000. Therefore, if the claim is for more than £200,000, the court fee is £10,000.Where the claim is for a non-monetary remedy, such as a revocation action or a claim for injunctive relief with no claim for damages,

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documents identified at (i), (ii) and (ix) in the answer to question 1.4, as well as the designated parts of (iii), (v), (vi) and (vii). The advocate for the claimant (usually a barrister, but sometimes a solicitor advocate) opens the trial with an address which follows and supplements the skeleton argument; at this stage, and throughout the trial, the judge will ask questions for clarification. Increasingly the defendant’s advocate may also give an opening speech. The claimant’s advocate then calls the claimant’s experts and witnesses to briefly confirm their written evidence, after which they are submitted to cross-examination by the defendant’s advocate. Experts and witnesses may be cross-examined upon any document or issue in the case. At the conclusion of each cross-examination, the claimant’s advocate may put questions to the expert or witness by way of re-examination (without leading the expert or witness to the answer) of the oral evidence given in cross-examination. After the closing of the claimant’s evidence, the same process is followed for the defendant’s evidence. The defendant’s advocate then addresses the judge following and supplementing his skeleton argument as necessary in the light of the evidence given to the court. Following this, the claimant’s advocate closes the trial with an address which supplements his skeleton argument in the light of the evidence. In the IPEC, the court may determine the claim without a trial if all parties consent. If there is a trial, the Enterprise Judge will determine the amount of time allocated to each party (and for cross-examination if any of the witnesses and experts) and set the timetable, in order that the trial should not last more than two days. An amendment of a party’s case requires the consent of the adversary or, failing that, the permission of the court exercising its discretion to allow or disallow the amendment. Whichever route applies, an amendment is likely to be subject to conditions addressing matters such as (i) the costs of consequential amendments to the adversary’s Statement of Case, (ii) the parties’ costs of the case up until the time of the amendment, (iii) consequential directions for the conduct of the action, including the timing of the trial, and (iv) the costs of adjourning any hearing or the trial. In general, in the Patents Court, amendments will be allowed subject to a costs order which reflects the wasted effort caused by the late introduction of a new allegation or position. The position in the IPEC is slightly less permissive because there is a costs cap in the IPEC, meaning that the costs caused by the amendment will have greater significance than in the Patents Court and, similarly, the costs-benefit analysis of permitting amendments is more thorough. This means that litigants have to be more circumspect about being able to amend their case in the IPEC; therefore, formulating it correctly at the outset is important.

1.6 How long does the trial generally last and how long is it before a judgment is made available?

On average, in the Patents Court, the trial will take three to five days, but the duration may be shorter in a very straightforward case, or longer in a complex case, where there is a need to hear evidence from several technical experts on each side. Trials in the IPEC are limited to two days. As indicated in the answer to question 1.5, in the IPEC there may be no trial at all (i.e. the case is decided upon the papers filed alone). A written judgment is generally handed down by the judge within four to eight weeks after the end of the trial.

1.7 Are judgments made available to the public? If not as a matter of course, can third parties request copies of the judgment?

Copies of reserved judgments in writing are generally supplied in confidence to the parties a few days before handing down. The judgment becomes public and may be freely disclosed when it

a potential defendant to quantify the value of a patent infringement claim and decide whether to litigate or settle. The patentee had repeatedly relied on the fact that others had taken licences in its efforts to persuade the alleged infringer to take a licence under the patent. (Big Bus v Ticketogo 2015.)

1.4 What are the steps each party must take pre-trial? Is any technical evidence produced, and if so, how?

The pre-trial procedural stages in the Patents Court consists of (i) service of the Claim Form on the defendant with Particulars of Claim and Particulars of Infringement showing which of the claims of the patent are alleged to be infringed, with at least one example of each type of infringement alleged, (ii) service of a Defence (and Counterclaim with Grounds of Invalidity, if applicable), (iii) hearing of the case management conference (CMC) before a judge, at which directions for the further conduct of the action are given, including deadlines for procedural steps and number of experts allowed, (iv) fixing of the trial date by the court listing office, (v) service of Notices to Admit and replies, to identify points that are not in dispute, (vi) exchange of lists of, and disclosure of, documents relevant to the issues between the parties – a defendant may, in lieu of giving disclosure in relation to the alleged infringing product (or process), serve a product (or process) description, (vii) carrying out of experiments permitted by the court to establish infringement (or invalidity), (viii) preparation and exchange of written factual and expert evidence, and (ix) provision to the court of skeleton arguments. The pre-trial procedure in the IPEC, in addition to the features identified above, differs from that in the Patents Court in the following respects: (i) the defendant(s) is given more time (70 days instead of 42 days) to serve a Defence if the claimant has not sent a letter identifying his claim before commencing the action; (ii) all Statements of Case must set out concisely all the facts and arguments that are relied upon; (iii) save in exceptional circumstances (see the answer to question 1.5 below), the judge will not allow the parties to supplement their Statements of Case; (iv) there is no disclosure of documents, unless ordered by the judge at the CMC; and (v) the extent (if any) that experiments, witness statements, experts’ reports, cross-examination at trial and skeleton arguments are permitted is determined by the judge at the CMC. Before the trial, the court is provided with (i) the Statements of Case (pleadings) including the Claim Form, Particulars of Claim, Particulars of Infringement, Defence (and Counterclaim if applicable, with Grounds of Invalidity), (ii) the patent(s), (iii) the prior art where invalidity is raised, (iv) Admissions, (v) Disclosure documents which the parties wish to rely upon and any product (or process) description, (vi) factual witness statements, (vii) experts’ reports, which may address any experiments that have been conducted, (viii) a technical primer (if any), (ix) a guide for the judge’s pre-trial reading, with a time estimate for that reading, and (x) each party’s skeleton argument. The parties are responsible for the preparation of bundles, including in the form of electronic or e-bundles, of these documents for the trial judge, which are generally provided about two weeks before the trial. As noted, (v) to (x) may not apply in a case in the IPEC.

1.5 How are arguments and evidence presented at the trial? Can a party change its pleaded arguments before and/or at trial?

Before the trial in the Patents Court, the judge will usually have read the documents indicated in the reading guide, namely, the

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In Fujifilm v AbbVie, the Court of Appeal confirmed the availability of “Arrow declarations” (named after the case of Arrow Generics v Merck where they were first granted in 2007). Arrow declarations are a discretionary remedy which may be used to clear the way in cases where, because the patents potentially blocking a new product or process are not yet granted, a declaration of non-infringement would not be available. Such declarations provide that the intended product or process was known or obvious at the priority date of the patent application of concern. As and when the patent is granted, the Arrow declaration will operate as a “Gillette” defence to any future infringement action: if the product or process is known or obvious, then so also is the patent it is alleged to infringe.

1.11 Can a party be liable for infringement as a secondary (as opposed to primary) infringer? Can a party infringe by supplying part of, but not all of, the infringing product or process?

Yes. A person infringes a patent where he supplies or offers to supply a person in the UK, other than a licensee, with any essential element of the claimed invention when he knows, or it would be obvious to a reasonable person in the circumstances, that this was suitable for putting, and intended to put, the claimed invention into effect in the UK. The supply, or offer to supply, of a “staple commercial product” is not an infringement unless it is made for the purposes of inducing infringement. Knowledge of the patent, actual or constructive, is not a pre-requisite for infringement (i.e. knowledge of the intended product or process is required rather than of the legal consequence), nor is knowledge of the intention of the ultimate user (it being sufficient that it would be obvious that some ultimate users would use the essential element so as to infringe).It is also possible to join parties which have assisted in the infringement as joint tortfeasors by pleading procurement or common design.

1.12 Can a party be liable for infringement of a process patent by importing the product when the process is carried on outside the jurisdiction?

Yes. It is an infringement of a process claim to import any product obtained directly by means of the process claimed. The meaning of “obtained directly by means of the process” has been considered by the courts on a number of occasions, and has been interpreted to mean: “the immediate product of the process”; or, where the patented process is an intermediate stage in the manufacture of some ultimate product, that product, but only if the product of the intermediate process still retains its identity.

1.13 Does the scope of protection of a patent claim extend to non-literal equivalents?

Yes. Courts in the UK apply Article 69 of the European Patent Convention and the Protocol on its Interpretation by giving patent claims a “purposive” interpretation, i.e. construing them in context, having regard to the inventor’s purpose, through the eyes of the man skilled in the art using his common general knowledge. The UK courts’ sole focus on claim construction to protect equivalents was, however, brought to an end by the recent decision of the UK Supreme Court in Actavis v Eli Lilly. The Supreme Court held that an item which did not infringe a claim as a matter of normal interpretation may nonetheless infringe because it varies from the invention in a way which is immaterial and provided guidance as to the circumstances in which a variation will be considered “immaterial”.

is handed down by the court, subject to any order to preserve the confidentiality of any material contained in the judgment. Judgments with parts redacted may be issued in such circumstances. Third parties can attend hearings when judgments are handed down and/or request copies of judgments from the judges’ clerks. The Royal Courts of Justice currently provide copies of significant judgments to the British and Irish Legal Information Institute (BAILII), for publication on the bailii.org website.

1.8 Are there specialist judges or hearing officers, and if so, do they have a technical background?

Yes to both. In the Patents Court, three of the designated judges have a science background, and are normally allocated to cases with a higher technical difficulty rating. The judge in the IPEC also has a technical background. There are also specialist patent judges in the Court of Appeal and in the Supreme Court.

1.9 What interest must a party have to bring (i) infringement, (ii) revocation, and (iii) declaratory proceedings?

(i) The claimant must be the owner or co-owner of the patent or an exclusive licensee, and, if a co-owner or exclusive licensee, the other co-owner(s) or the owner must be joined to the proceedings.

(ii) The claimant need not have any commercial or other interest. (iii) Declaratory proceedings fall into two categories: statutory

proceedings (as set out in the Patents Act 1977); and proceedings under the court’s inherent jurisdiction (whose scope is flexible). A person may seek a declaration that the performance of an act in relation to a product or process would not infringe a patent either on statutory grounds or under the discretion of the court: if the statutory grounds are used, the person must first provide the patent owner with full particulars of the act in question, seeking an acknowledgment that it would not infringe the patent; or if an acknowledgment is not provided, the person may bring proceedings for a declaration of non-infringement. A person may otherwise bring proceedings for such a declaration, in reliance upon the court’s inherent discretion, if such a negative declaration (of non-infringement) is sufficiently well-defined and would serve a useful purpose.

1.10 If declarations are available, can they address (i) non-infringement, and/or (ii) claim coverage over a technical standard or hypothetical activity?

(i) Yes, as indicated above (question 1.8). (ii) UK courts have a wide discretion to grant any form of

declaratory relief (whether affirmative or negative), provided that the declaration sought is sufficiently well-defined, and that it would serve a useful purpose (in the sense that there must be a real commercial reason for the person seeking the declaration in order to have standing to do so). Thus, the Patents Court has been willing to grant negative declarations in favour of a mobile telephone handset manufacturer that certain telecommunications patents declared as “essential” to the implementation of certain European Telecommunications Standards Institute (ETSI) standards are not, in fact, “essential”, as purported by the patent owner. On the other hand, the court will be reluctant to entertain declaratory proceedings where there is no real prospect that the declaration sought will resolve a real (as opposed to hypothetical) commercial issue between the parties.

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and (ii) the fact that resolution of the national proceedings may promote settlement. The public interest in dispelling the uncertainty surrounding the validity of monopoly rights conferred by the grant of a patent remains a factor to be considered. In weighing the balance, the risk of wasted costs is material, but will normally be outweighed by commercial factors concerned with early resolution. Overall, the guidelines mean that the time delay inherent in EPO opposition proceedings is to be given less weight than previously.

1.17 What other grounds of defence can be raised in addition to non-infringement or invalidity?

The right to continue to do something already done (or where effective and serious preparations to do such act were done) before the priority date of the patent can be raised as a defence. Such prior use must be in public, done in good faith, in the UK, and is personal as it does not extend to granting a licence to another person to do the act. The main other substantive defence is that the defendant has the benefit of, or is entitled to, a licence. This may be raised in various ways, depending on the factual and legal background. Statutory grounds for a licence may be available, inter alia, because: (i) the patent owner has registered the availability of licences as of right; (ii) compulsory licences are available three years from grant of the patent where (a) broadly speaking, the invention or another invention “which makes a substantial contribution to the art” is not being commercially worked in the UK, or (b) the UK Intellectual Property Office has made a register entry against the patent that licences are available as of right as a result of a Competition Commission report to Parliament; and (iii) compulsory licences are available for service to the Crown: in each case subject to the payment of royalties (which are determined by the court in default of agreement by the parties which, in turn, means that these provisions are hardly used). Contractual or quasi-contractual grounds for a licence may exist where the defendant and the patent owner are involved in some joint technology initiative or enterprise which explicitly or implicitly gives rise to entitlement to a licence, either on agreed terms or on terms to be agreed which are reasonable.

1.18 Are (i) preliminary, and (ii) final injunctions available, and if so, on what basis in each case? Is there a requirement for a bond?

(i) Preliminary (interim) injunctions are available and are granted if (a) there is a serious issue to be tried, that is to say there is an arguable case, (b) the “balance of convenience” favours an injunction or, all things considered, is even (this involves consideration of factors such as: the irreparability of the harm to the claimant and to the defendant respectively if an injunction were refused or granted; the adequacy of damages and ability to estimate damages payable to the claimant and defendant respectively if an injunction were refused or granted; and the proximity of the trial), and (c) the claimant gives a cross-undertaking to compensate the defendant in damages if the injunction is wrongly granted. In pharmaceutical cases where a defendant proposes to introduce a generic product, the claimant can normally show that there will be irreparable damage as a result of irreversible price erosion. In such cases, interim injunctions are relatively common. However, if generic manufacturers lose the “first mover” advantage as a result of an injunction wrongly granted, a liberal assessment of damages will be made under the cross-undertaking.

(ii) Final injunctions are generally granted if the claimant is successful at trial, unless this would be “grossly disproportionate”. A stay of an injunction pending appeal, so as to permit the Court of Appeal to do justice whatever the outcome of the appeal, may be granted on the “balance

1.14 Can a defence of patent invalidity be raised, and if so, how? Are there restrictions on such a defence e.g. where there is a pending opposition?

Yes. This can be raised as a defence, and is normally also accompanied by a Counterclaim for revocation, supported by Grounds of Invalidity, with copies of each document relied upon.A Claim or Counterclaim for revocation may be raised regardless of whether there is a pending opposition. See the answer to question 1.15 for the factors weighed by the court when deciding whether or not to stay an infringement action, including any Counterclaim with Grounds of Invalidity, pending an opposition. Since October 2014, the UK Intellectual Property Office (UKIPO) has also had the power to revoke a patent following an unfavourable validity opinion relating to novelty or inventive step requested by a third party. This power to revoke is exercised only in “clear-cut” cases. In February 2016, in a case where the patentee did not contest the negative opinion, the UKIPO issued a decision revoking a patent for the first time.

1.15 Other than lack of novelty and inventive step, what are the grounds for invalidity of a patent?

The principal grounds are (i) insufficiency (lack of enablement), (ii) lack of industrial applicability, (iii) extension of the subject matter in the specification during prosecution or opposition proceedings over and above the matter contained in the application as filed, (iv) extension of the scope of protection of the patent by a pre- or post-grant amendment to the claims that should not have been allowed, and (v) the patent was granted to someone who was not entitled to it.

1.16 Are infringement proceedings stayed pending resolution of validity in another court or the Patent Office?

The question of whether a stay of infringement proceedings (with or without a UK invalidity counterclaim) should be granted pending resolution of validity of the patent in the European Patent Office (EPO) is a matter of discretion for the court to exercise, addressing whether, on balance, a stay is in the interests of justice. (It should be noted that validity proceedings in the UK Intellectual Property Office are normally transferred to the court when an infringement action is commenced there, so there is no question of a stay then; and that validity of a corresponding patent in another country is generally considered to be irrelevant, and so is not grounds for a stay in the UK.) The Court of Appeal has issued guidance on when English patent proceedings should be stayed pending the outcome of opposition proceedings in the EPO: if there are no other factors, a stay of the national proceedings is now the default option. The onus is on the party resisting the grant of the stay to adduce evidence why it should not be granted. While the typically shorter length of time that it will take for the proceedings in the national court, as compared with the EPO to reach a conclusion, remains an important factor affecting the discretion, this has to be considered in conjunction with the prejudice that any party will suffer from the delay, and what the national proceedings can achieve in terms of certainty. Two other factors are also taken into consideration: (i) the extent to which refusal of a stay will irrevocably deprive a party of any part of the benefit that the concurrent jurisdiction of the EPO and the national court is intended to confer (for example, if allowing the national court to proceed might allow the patentee to obtain monetary compensation that is not repayable if the patent is later revoked, this would be a factor in favour of the grant of a stay);

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publication of the judgment, at the expense of the infringer (in compliance with the UK’s obligations under Directive 2004/48/EC on Enforcement of IP Rights), and/or (iii) an award of costs.In a case where validity was not in issue, the English court granted declarations of non-infringement in respect of the foreign counterparts of a UK European patent, a decision which has been upheld by the Court of Appeal. In most cases, however, where validity is raised as a counterclaim, there can be no cross-border relief in relation to a European patent because the other countries designated have exclusive jurisdiction over patent validity.

1.22 How common is settlement of infringement proceedings prior to trial?

Many patent actions do settle before trial, although this is less likely to happen, for example, in the case of major pharmaceutical patent litigation, where the stakes for both parties are very high. Mediation or other forms of ADR aimed at settling the dispute before trial are actively encouraged by the courts as part of their increased involvement in case and costs management.

1.23 After what period is a claim for patent infringement time-barred?

The time period is six years from when the cause of action accrued. Where there is concealment of the infringement, the six-year limitation period does not start to run until the claimant discovers the concealment or could with reasonable diligence discover it.

1.24 Is there a right of appeal from a first instance judgment, and if so, is it a right to contest all aspects of the judgment?

A judgment may be appealed if the trial judge or the Court of Appeal (if the trial judge refuses permission to appeal) considers that the appeal has “a real prospect of success”. The prospect of success must be realistic and credible. New evidence or material is not allowed on appeal unless it could not, with due diligence, have been found for use at the trial, and even then, it is only allowed when it is likely to have a material effect on the appeal. The Court of Appeal is always reluctant to interfere with findings of fact by the trial judge or with value judgments such as obviousness. This has the consequence that grounds of appeal should, wherever possible, identify errors of law or application of the law. The Court of Appeal confirmed in Teva v Boehringer Ingelheim that applications for permission to appeal in patent cases should be treated no differently to any other case and in particular should not be granted more easily than in other cases because of the complex technical subject matter.

1.25 What are the typical costs of proceedings to first instance judgment on (i) infringement, and (ii) validity? How much of such costs are recoverable from the losing party?

In the UK, infringement and validity are dealt with together, at the same trial. The typical cost of an action involving both infringement and validity is in the region of £550,000 to £850,000 for the Patents Court (much lower for the IPEC) depending on such matters as the number of patents/claims in dispute, the number and nature of the invalidity attacks, and whether more than one expert is required to give evidence at the trial. In more complicated actions involving extensive disclosure of documents or experiments, the

of convenience principle” and, if an injunction is granted or maintained pending appeal, the claimant may be required to give an undertaking to compensate the defendant if the injunction is lifted by the Court of Appeal. It is important to bear in mind that all injunctions are discretionary. Article 3(2) of the Enforcement Directive also requires the court to refuse to grant an injunction where it would be “disproportionate” to grant one. Case law, however, confirms that in a patent case, where an injunction is the primary way of enforcing that right, the burden on a party seeking to show that the grant of an injunction would be disproportionate is a heavy one.

1.19 On what basis are damages or an account of profits assessed?

In the UK, the quantum of damages (or account of profits) payable by a losing defendant is always assessed after, and separately from, the trial on liability for patent infringement in a procedure known as “the inquiry as to damages”. The claimant is given disclosure by the defendant at the start of this procedure to enable it to elect whether to pursue damages or an account of profits (a claimant cannot seek both). An account of profits is very rarely chosen in a patent action, given the complexity of technical and commercial factors that contribute to a defendant’s profits. Damages are estimated by the court at a hearing (effectively a trial) on the basis of the disclosure and expert evidence provided to it. The principles applied by the court, in simple terms, are (i) damages are only compensatory (not punitive), (ii) the burden of proof lies on the claimant, but damages are to be assessed liberally, (iii) where the patent has been licensed, the damages are the lost royalty, (iv) it is irrelevant that the defendant could have competed lawfully, and (v) where the patent owner has exploited the patent by manufacture and sale, he can claim (a) lost profits on sales by the defendant which he would otherwise have made, (b) lost profits on his own sales, to the extent that he was forced to reduce his own price, and (c) a reasonable royalty on sales by the defendant which he would not otherwise have made.

1.20 How are orders of the court enforced (whether they be for an injunction, an award of damages or for any other relief)?

Damages awards or other financial orders of the court may be enforced in two ways: through bailiffs as officers of the court seizing the assets of the non-compliant party and auctioning them off to meet the order; or by the filing of a statutory demand against a company resulting in the winding up of the company. Orders to freeze bank accounts and for sequestration of a judgment debtor’s assets are also possible in appropriate cases.Failure to comply with an order made by a court to do or refrain from doing something may result in proceedings being brought for contempt of court. The penalties for being found to be in contempt of court include a custodial sentence of up to two years and/or an unlimited fine or seizure of assets. In the case of contempt of court by a company, the court can order, in certain circumstances, the committal into custody of a director or other company officer. Given the serious nature of the penalties, contempt is assessed using the criminal standard of proof, i.e. beyond reasonable doubt, as opposed to on the balance of probabilities for civil matters.

1.21 What other form of relief can be obtained for patent infringement? Would the tribunal consider granting cross-border relief?

The court may order (i) the delivery up or destruction of infringing goods, and/or (ii) appropriate measures for the dissemination and

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2 Patent Amendment

2.1 Can a patent be amended ex parte after grant, and if so, how?

Yes, by applying for an amendment to the UK Intellectual Property (Patent) Office. The application is advertised by the UKIPO on its website and in its journal, and third parties may oppose the amendment (therefore, ex parte examination of the application is not, in fact, assured). Central amendment of the UK designation of a European patent, in accordance with the European Patent Convention (EPC), is also possible via proceedings at the European Patent Office (EPO).

2.2 Can a patent be amended in inter partes revocation/invalidity proceedings?

Yes. Amendment is at the discretion of the court, and the validity of the patent as proposed to be amended will be addressed by the court before allowing it. If the patent owner fails to seek amendment before the patent is revoked at first instance, he will generally be refused permission to amend on appeal, as this is regarded as an impermissible attempt to re-litigate issues that should have been addressed at first instance.

2.3 Are there any constraints upon the amendments that may be made?

The constraints are the same as those that apply under the EPC, namely, that an amendment will not be allowed if it would extend (i) the subject matter over and above the disclosure contained in the application for the patent, or (ii) the extent of protection; or if it would not cure the ground of invalidity (if the amendment is made to cure potential invalidity). The amended claim must also be supported by the specification in the same way as during prosecution.

3 Licensing

3.1 Are there any laws which limit the terms upon which parties may agree a patent licence?

Yes, competition law (EU, until the UK exits the EU, and UK) prohibits terms in a licence which are restrictive of competition in the relevant market, in the sense that the terms go beyond what the monopoly conferred by the patent accords to the owner or exclusive licensee. Thus, terms such as price fixing, limitations on output, allocation of customers, and restrictions upon the use of the licensee’s own technology are potential violations of competition law. The penalties include unenforceability of the offending terms and/or fines.

3.2 Can a patent be the subject of a compulsory licence, and if so, how are the terms settled and how common is this type of licence?

Yes, see the answer to question 1.17 above.

cost will be higher and, in some cases, substantially higher. The judges are increasingly proactive in the exercise of their case management powers to reduce costs – see especially the comments on the procedures in the IPEC in the answer to question 1.4. In the Patents Court, following the recent introduction of wide-ranging procedural reforms, parties must now prepare and exchange costs budgets (except where the value of the claim is certified to be £10 million or more). Costs budgets are designed to give the parties and the court visibility of the likely costs to be incurred by both sides and the opportunity for the court to manage them to ensure proportionality. Although the general rule is that costs follow the event, and therefore that the overall winner can expect to be awarded their costs of the action, the Patent Court adopts an issue-based approach which means that, in practice, a discount will be made for the costs of those issues on which the winner lost. A party in whose favour a costs order is made would normally expect to recover approximately 65–75% of their actual legal costs which are the subject of that order. Where costs budgets have been employed, the winning party is likely to recover 80–90% of those costs.

1.26 For jurisdictions within the European Union: What steps are being taken in your jurisdiction towards ratifying the Agreement on a Unified Patent Court, implementing the Unitary Patent Regulation (EU Regulation No. 1257/2012) and preparing for the unitary patent package? For jurisdictions outside of the European Union: Are there any mutual recognition of judgments arrangements relating to patents, whether formal or informal, that apply in your jurisdiction?

Following the UK’s referendum vote on 23 June 2016 to leave the European Union, on 29 March 2017 the UK initiated the two-year exit procedure envisaged by Article 50 of the Treaty of the European Union. The UK is expected to enter a negotiation period during which laws will be amended and enacted and international agreements may be negotiated. Due to the required notice period, the actual exit date will not be before March 2019. The UK, along with France and Germany, is required to ratify the Unified Patent Court (UPC) Agreement before it comes into force. The “Brexit” vote has inevitably delayed the implementation of the UPC system, which will not become operational in December 2017 as originally planned. However, the UK indicated in November 2016 that it intends to ratify the UPC Agreement. The necessary secondary legislation to give the UPC its legal personality in the UK, the UPC (Immunities and Privileges) Order 2017, has been laid before the Westminster Parliament (a similar instrument needs to be laid before the Scottish Parliament) and, once they have passed, the UK will be able formally to ratify the UPC Agreement.Absent renegotiation of the UPC Agreement, when it exits the EU, the UK, whilst it will still be a signatory to the European Patent Convention and a European (UK) patent could still be obtained via the EPC system, will not be able to participate in the new UPC system, which only applies to participating EU Member States. Since, for the majority of potential users of the UPC, the system would be less valuable without the participation of the UK, it is hoped that the considerable goodwill of all those involved in the project for many decades will overcome any political obstacles preventing amendments or further agreements to facilitate the UK’s continuing involvement.

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5.3 May the grant of a patent by the Patent Office be opposed by a third party, and if so, when can this be done?

No, the only way of doing this post-grant in the UK is to seek revocation. However, the grant of a European patent which designates the UK may be opposed at the European Patent Office.

5.4 Is there a right of appeal from a decision of the Patent Office, and if so, to whom?

Yes, an appeal lies to the Patents Court.

5.5 How are disputes over entitlement to priority and ownership of the invention resolved?

An application for a determination as to entitlement may be made before, or up to two years from, grant of a patent to the UK Intellectual Property Office. The UKIPO may refer the application to the Patents Court if the issues can be more properly determined there (where the rules on disclosure and evidence permit better examination of factually contested cases). Issues as to entitlement to priority are normally dealt with ex parte during the prosecution of the patent application, or inter partes in revocation proceedings.

5.6 Is there a “grace period” in your jurisdiction, and if so, how long is it?

Under the EPC, and correspondingly in the UK under section 2(4) of the Patents Act 1977, there are certain limited exceptions which remove from the “state of the art” material which would otherwise form part of it. In the UK, the following matter disclosed during the six months prior to filing is so excluded: (a) a matter which is disclosed due to, or disclosed in consequence of, the matter having been obtained unlawfully or in breach of confidence by any person, which is directly or indirectly derived from the inventor; and (b) a matter which is disclosed due to, or disclosed as a consequence of, the inventor displaying the invention at a designated “international exhibition”. In the latter case, the applicant must, to benefit from the “grace period”, file a statement and evidence relating to the disclosure at the international exhibition.

5.7 What is the term of a patent?

The term is 20 years from filing.

6 Border Control Measures

6.1 Is there any mechanism for seizing or preventing the importation of infringing products, and if so, how quickly are such measures resolved?

Yes, the EU Regulation concerning customs measures against goods suspected of infringing IP rights may be used to seize goods which infringe a patent or an SPC from entering the UK from outside the EU. An application to HM Revenue & Customs should be made at least 30 working days before the expected date of importation, with sufficient identification of the goods and the patented subject matter and with an undertaking to pay all the liabilities and costs of the seizure. Upon seizure, a notice is provided to the patent owner, who must apply to the court within 10 working days for an order

4 Patent Term Extension

4.1 Can the term of a patent be extended, and if so, (i) on what grounds, and (ii) for how long?

No, but a form of “extension” is available in EU Member States in respect of patents which cover an authorised medicinal or plant protection product, called a Supplementary Protection Certificate (SPC). The intent of the EU SPC Regulation is to reward investment in approval of a medicinal or plant protection product, and SPCs are obtained in each country by filing an application with the relevant Patent Office within six months of the grant of the first authorisation of the product in that country. The scope of protection of an SPC is limited to the product as authorised, and it takes effect upon expiry of the “basic” patent covering the product for a maximum term of five years or 15 years from the authorisation of the product, whichever is the earlier. The UK’s exit from the EU means that legislation will be required to enable SPC protection to continue to apply in the UK. The exact form of the new law will depend on whether the UK stays in the European Economic Area (EEA), but some form of SPC protection will probably be established. Transitional provisions will also need to be established for SPCs in force at the time of exit, in order to ensure that they continue to have effect in the UK.

5 Patent Prosecution and Opposition

5.1 Are all types of subject matter patentable, and if not, what types are excluded?

Yes, in accordance with its obligations under the European Patent Convention (EPC) and the WTO TRIPS Agreement, the UK Patents Act allows patents for all forms of technology. However, methods of performing a mental act, playing a game or doing business and programs for computers are excluded, as are inventions the commercial exploitation of which would be contrary to public policy or morality.The UK’s exit from the EU does not affect the ability to obtain UK patent protection via the EPC. The UK Patents Act has implemented various EU Directives over the years, for example the Biotech Directive and the “Bolar” (experimental use exemption) Directive, but these implementations will not necessarily be repealed when the UK leaves the EU.

5.2 Is there a duty to the Patent Office to disclose prejudicial prior disclosures or documents? If so, what are the consequences of failure to comply with the duty?

No, there is not. However, certain statements by the Court of Justice of the European Union in Case C-457/10P (AstraZeneca) make it clear that a patent owner in a dominant position in the market is under an obligation (under competition law) to act transparently before the Patent Office – in that case, the penalty was the imposition of a fine. The European Patent Office requires an applicant for a patent to provide the results of any official search carried out on any priority application (other than one made in Japan, the UK or the US or one for which the European Patent Office drew up the search report), but there are no immediate legal consequences for failure to do so, save, perhaps, that an applicant in a dominant position is now clearly under a duty to disclose such prior art given the AstraZeneca decision.

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can be the same as an injunction, where the claimant has been forced to come to court, an offer of undertakings after judgment is likely to be regarded as too late.There have been significant, but as yet inconclusive, developments in relation to the infringement of second medical use patents in two long-running disputes involving the drugs pregabalin and pemetrexed, in particular the extent to which any relevant intention or knowledge is negatived where the manufacturer has taken all reasonable steps within his power to prevent certain consequences occurring.The pemetrexed litigation (Actavis v Eli Lilly) concerned Eli Lilly’s patent with Swiss-type claims to the use of pemetrexed disodium for the treatment of cancer. The question was whether preparations of pemetrexed salts would be reconstituted with saline so creating the patented solution pemetrexed disodium. The Court of Appeal considered that Eli Lilly’s patent was not directly infringed by Actavis’s pemetrexed products but that indirect infringement would occur as a result of the reconstitution with saline by healthcare practitioners, notwithstanding instructions to reconstitute with dextrose. However the Supreme Court recently reversed the Court of Appeal and found that the Actavis products directly infringed. It also found obiter there would have been indirect infringement. The decision is an extremely important one for the law of patent infringement in the UK. The Supreme Court held that an item which did not infringe a claim as a matter of normal interpretation may nonetheless infringe because it varies from the invention in a way which is immaterial. In so doing, it reformulated the law as to the circumstances in which a variation will be considered immaterial, moving away from the previous focus in the UK on claim construction to protect equivalents.The pregabalin litigation (Warner-Lambert v Actavis) is also concerned with issues of intention and knowledge in the context of second medical use patents. The judge found that Warner-Lambert’s patent for the use of pregabalin in the treatment of pain was invalid and in any event not infringed by Actavis’ skinny label pregabalin product. The Court of Appeal upheld the judge’s findings on the validity of the patent but disagreed with him, obiter, on issues concerning the construction and infringement of Swiss type claims (Warner-Lambert Company LLC v Generics (UK) Ltd (t/a Mylan) & Ors). For the Court of Appeal, the issue on direct infringement was whether Actavis knew or could reasonably foresee that at least some of the prescriptions written generically for pregabalin to treat pain (the patented indication) would in fact be fulfilled with its product. On indirect infringement the Court of Appeal considered that the process of preparing the composition can continue through any packing step performed by the manufacturer and includes the labelling step performed by the pharmacist. Such acts, performed downstream of manufacture, could therefore be regarded as relevant acts of preparation if done with the relevant intention. Various issues are currently under appeal and a judgment of the Court of Appeal is expected.

8.2 Are there any significant developments expected in the next year?

The UK is expected to ratify the UPC Agreement in the course of the next year. Assuming Germany also ratifies, although the exact timetable for the start of the operation of the UPC has not yet been set, if there are no further obstacles, it is possible the sunrise period for opt-outs could start on 1 January 2018 and the court might open for business on 1 March 2018. It is likely that during the next year there will be negotiations about the exact terms of the UK’s formal departure from the EU. The UK

for the further detention (or destruction) of the goods. Following the departure of the UK from the EU, however, customs seizure remedies across the EU will cease to be available to IP owners. Depending on any agreement which may be negotiated, it will probably be necessary to file a request for border seizure measures with both the European customs authorities and the UK’s Border Force. The latter has a separate unit under the Trade Marks Act 1994 to seize counterfeit goods.

7 Antitrust Law and Inequitable Conduct

7.1 Can antitrust law be deployed to prevent relief for patent infringement being granted?

Yes, although a competition law defence has never succeeded in a patent action.

7.2 What limitations are put on patent licensing due to antitrust law?

See the answer to question 3.1 above.

8 Current Developments

8.1 What have been the significant developments in relation to patents in the last year?

The three specialist patents judges assigned to patent actions with a high technical complexity rating continue to be Mr. Justice Arnold, Mr. Justice Birss and Mr. Justice Henry Carr. Seven other judges of the Patents Court may hear less technically complex patent cases, as well as a continuing number of Deputy High Court judges with patent expertise including Daniel Alexander QC, Iain Purvis QC, Roger Wyand QC, John Baldwin QC, Douglas Campbell QC and HHJ Richard Hacon (who also presides over the Intellectual Property Enterprise Court). The Court of Appeal’s confirmation in Fujifilm v AbbVie of the availability of “Arrow declarations” (see response to question 1.10) was a significant development. Arrow declarations have since been granted following full trial of the action. Special reasons supporting the grant of the declarations included: AbbVie’s conduct of threatening infringement but abandoning proceedings at the last moment (in order to shield its patent portfolio from scrutiny); the amount of money at stake in terms of investment in clinical trials and potential damages if Fujifilm’s intended products were launched at risk; and the need for commercial certainty, having regard to AbbVie’s threats to sue for infringement throughout the world.After the technical trials in Unwired Planet v Huawei, the court held a separate trial to determine the issue of a FRAND royalty rate (on fair, reasonable and non-discriminatory terms) over a worldwide portfolio of patents. A further remedies hearing considered the correct form of a final injunction in the case of patents subject to a FRAND undertaking when the court has settled a FRAND licence but the defendant has not entered into it. It held that a FRAND injunction should be granted to restrain infringement of the relevant patents with a proviso that it will cease to have effect if the defendant enters into the FRAND licence. The court noted that the grant or refusal of an injunction is an exercise of the court’s discretion although when infringement has been established and there is a threat of infringement in the future, an injunction will normally be granted. Although the practical effect of undertakings

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by a technical primer, the expert witnesses and the parties’ legal teams. However, where a case involves a difficult area of science, the parties may arrange for the judge to have a non-controversial introductory course. Transparency is maintained by settling the instructions to the adviser in advance and by giving any written materials produced by the scientific adviser for the judge to the parties after the introductory course has taken place. In the same case, the court gave guidance in relation to use of experiments. Where computer simulations or computer modelling are involved, the input data and computer software must be disclosed to the other party for the purpose of witnessed repeat experiments. The court also emphasised that it must be clearly explained what facts the experiments were supposed to prove and their relevance to the case.In MSD v Shionogi, the court gave guidance on cross-examination of expert witnesses in patent cases emphasising that courts should be cautious in criticising experts on the basis of omissions from their reports since this may result from incorrect instructions. ASE v Rapiscan also dealt with the importance of correctly instructing expert witnesses, in particular the order in which they are shown the relevant documents in order to avoid being tainted with hindsight. Experts should be asked to consider common general knowledge and the prior art before they are shown the patent. The court preferred asking experts to consider obviousness before showing them the patent so that they can consider whether or not differences between the prior art and the invention are obvious steps free from knowledge of the patent.

Government’s White Paper, “Legislating for the United Kingdom’s withdrawal from the European Union” proposes that the Repeal Bill will ensure so far as possible that the same rules and laws apply after the UK leaves the EU as did before, unless and until domestic law is changed by legislators in the UK. This will include converting directly applicable EU regulations into UK law and preserving laws made in the UK to implement EU directives. The Bill will also provide that, for the sake of certainty, historic CJEU case law should be given the same binding precedent status in UK courts as Supreme Court decisions. As noted in the answer to question 8.1, the Court of Appeal is expected to rule on the pregabalin litigation.

8.3 Are there any general practice or enforcement trends that have become apparent in your jurisdiction over the last year or so?

The Practice Statement of December 2015 requiring patent cases to be brought to trial within 12 months where possible remains in force and is an influential trend in practice. Judges have, for example, refused to allow jurisdictional challenges and strike-out applications to adjourn the listing of the trial date. Split trials have also been ordered in multiple patent actions in order to ensure the trial takes place within the 12 month guideline.In EMGS v PMS, the court gave general guidance about whether the court should sit with a scientific adviser. Patents judges with a technical background can generally handle complex cases assisted

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Katharine StephensBird & Bird LLP12 New Fetter LaneLondon, EC4A 1JPUnited Kingdom

Tel: +44 20 7415 6000Fax: +44 20 7415 6111Email: [email protected]: www.twobirds.com

Audrey HortonBird & Bird LLP12 New Fetter LaneLondon, EC4A 1JPUnited Kingdom

Tel: +44 20 7415 6000Fax: +44 20 7415 6111Email: [email protected]: www.twobirds.com

Hailed by Managing IP as ‘IP Firm of the Decade’ in 2015 and ‘European Patent Firm of the Year’ in 2017, Bird & Bird consistently remains at the forefront of intellectual property law.

Particularly commended for its strength in IP strategy and litigation, it’s this first-class reputation that allows the firm to attract and retain world-leading patent advisors and litigators.

The majority of the firm’s work is cross-border in nature, and they are regularly called to advise on ground-breaking patent cases. Due to their geographic spread, they are also able to litigate in some of the most prominent patent litigation jurisdictions, providing invaluable experience on the approach and attitude of the courts in different jurisdictions, which enables them to devise and tailor litigation strategies accordingly.

Not only does the firm have the range and depth of expertise, but with more than 300 specialist lawyers across 28 offices, they have numbers in force.

www.twobirds.com

@twobirdsIP

Katharine Stephens is co-head of the London Intellectual Property Group, and has been a partner at Bird & Bird since 1999. She specialises in patent, trade mark and design litigation, often coordinating and running actions in more than one jurisdiction.

With a Master’s degree in Mechanical Engineering from Bristol University, Katharine has a particular interest in the electronic, computer technology and engineering sectors. Many of the patent actions which she has been involved in over the years concern standard essential patents and patent pools, and she is therefore experienced in dealing with the patent and competition law issues raised in such cases.

She is also experienced in designing and implementing European-wide protection and enforcement strategies based on trade marks and designs.

Katharine has been recognised as one of the ‘Top 250 Women in IP’ by Managing IP, a position which she’s held for the past two years, and is highly ranked across all areas of IP in the major legal guides. She reports each month on trade mark, copyright and design cases for the Chartered Institute of Patent Attorneys Journal.

Audrey Horton is a senior associate and IP Knowledge and Development Lawyer in Bird & Bird’s Intellectual Property Group, based in the London office.

Audrey’s practice covers the full spectrum of intellectual property rights, including patents, confidential information, trade marks, designs, copyright, and database rights. Her experience also encompasses drafting and negotiating contracts for the creation, transfer or licensing of intellectual property.

Audrey has written and lectured on a wide range of intellectual property topics, including industrial design rights, trade marks and passing off, research and development agreements, unfair competition law and IP-related jurisdictional issues. Her articles have been published in various journals, including the European Intellectual Property Review, the ITMA Review and Managing Intellectual Property. She is co-author of Practical Intellectual Property Precedents (Sweet & Maxwell) which is updated regularly.

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part of a judgment. Local patent rules often require additional initial disclosures. The parties may prepare and file a joint discovery plan ahead of the scheduling conference. The parties then exchange written discovery (e.g., interrogatories and requests for admission), documents, and depose witnesses. Non-parties to a proceeding may be compelled to provide discovery (documents and deposition testimony) through subpoena practice. If a party or non-party fails to provide requested discovery, the requesting party may move to compel such discovery.

1.4 What are the steps each party must take pre-trial? Is any technical evidence produced, and if so, how?

Pre-trial procedure specifics vary from court to court. Generally, the first phase includes an exchange of pleadings (e.g., complaint, answer and counterclaims). A scheduling order is typically issued within three months of the complaint being served. The parties next engage in fact discovery. Some courts may also require that infringement, invalidity, or unenforceability contentions be exchanged. Motion practice to resolve discovery disputes is common. Generally, fact discovery is followed by expert discovery on technical and/or damages issues; this period includes exchange of expert reports and deposition of expert witnesses.Courts are required, as a matter of law, to resolve the meaning of disputed claim terms. Claim construction proceedings include significant briefing and a hearing (“Markman hearing”). The average time from filing to a Markman ruling was 23 months (as of 2016). Depending on the complexity of the issues, the court may request or allow a technical tutorial. After a Markman order, litigants often have an opportunity to file updated infringement and invalidity contentions. Once discovery ends, summary judgment motions and motions to limit the evidence available for trial, including motions to exclude expert witnesses, may be filed. Before trial, litigants exchange pre-trial statements that identify witnesses and exhibits to be introduced at trial, and objections to the same. Failure to disclose an exhibit or objection may waive a party’s right to use or object to the exhibit or witness at trial. Proposed jury instructions for the court to consider may also be submitted.

1.5 How are arguments and evidence presented at the trial? Can a party change its pleaded arguments before and/or at trial?

Generally, patent infringement cases in district courts are tried before a

1 Patent Enforcement

1.1 Before what tribunals can a patent be enforced against an infringer? Is there a choice between tribunals and what would influence a claimant’s choice?

The federal district courts, located throughout the United States, are the trial courts in patent cases. Provided certain jurisdictional requirements are met, a party may also enforce their patent rights at the United States International Trade Commission (“ITC”). The ITC is a federal administrative agency that hears claims of patent infringement for imported goods accused of infringing U.S. patent rights. Decisions from patent cases from district courts and the ITC are appealed to the United States Court of Appeals for the Federal Circuit (“Federal Circuit”).Litigants have some flexibility in selecting the venue for their case. This selection depends on, for example, the facts and strategy of the case, compliance with personal jurisdiction and venue requirements, and the available remedies. For example, patentees can obtain damages and/or injunctions in a district court, but in the ITC, only injunctive relief prohibiting importation into the United States is available.

1.2 What has to be done to commence proceedings, what court fees have to be paid and how long does it generally take for proceedings to reach trial from commencement?

In district courts, patentees commence an infringement action by serving the accused infringer with a summons and complaint for patent infringement. The complaint must meet certain pleading requirements and requires a filing fee of $400. Service of process requires additional, nominal fees. Depending on the court, the pre-trial period may be as short as nine months but is normally closer to two years.In the ITC, a patentee must file a complaint to initiate an investigation. The pre-trial period is typically completed within eight to nine months after the ITC initiates the investigation.

1.3 Can a party be compelled to disclose relevant documents or materials to its adversary either before or after commencing proceedings, and if so, how?

Shortly after a lawsuit has commenced, the rules require parties to initially exchange information concerning individuals and repositories likely to have discoverable information, disclose a computation of damages, and provide any insurance agreement that may satisfy all or

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expertise. At the appellate level, some of the judges at the Federal Circuit have technical backgrounds, and most have substantial patent law experience.

1.9 What interest must a party have to bring (i) infringement, (ii) revocation, and (iii) declaratory proceedings?

Patentees and their exclusive licensees have standing to bring infringement suits in district courts. Non-exclusive licensees may bring suit only by joining the licensor. To appear at the ITC, a party must have an interest in the patent and must establish that it has a domestic industry. A party that is threatened with a patent infringement lawsuit or faces an immediate, realistic and substantial risk of being involved in an actual case or controversy, may preemptively file a declaratory judgment action in district court to have the patent declared invalid or not infringed.The validity of U.S. patents may also be challenged at the U.S. Patent Office Patent Trials and Appeal Board (“PTAB”) through ex parte and inter partes proceedings including ex parte reexamination, inter partes review (“IPR”), post-grant review (“PGR”), and covered business method reviews (“CBM”). A petition for IPR, PGR or CBM may not be brought by the patentee. A patentee, however, may file a request for ex parte reexamination of a patent.

1.10 If declarations are available, can they address (i) non-infringement, and/or (ii) claim coverage over a technical standard or hypothetical activity?

During litigation, parties can provide declarations of fact and/or expert witnesses to support arguments concerning claim construction, liability, validity and damages issues. Such declarations are often used to support motions for summary judgment on infringement or validity. Declarants are generally subject to cross-examination.

1.11 Can a party be liable for infringement as a secondary (as opposed to primary) infringer? Can a party infringe by supplying part of, but not all of, the infringing product or process?

Induced infringement and contributory infringement are available in the United States.To prove induced infringement, a patentee must show that the accused infringer actively encouraged infringement, knowing that the induced acts constituted patent infringement, and direct patent infringement actually resulted from the induced acts. Liability for contributory infringement arises from the offer to sell, sale in the US or importation into the United States of a component of a patented device, article of manufacture, or a combination or composition or a material or apparatus for use in practising a patented process, where the item at issue constitutes a material part of the patented invention and has no non-infringing uses.

1.12 Can a party be liable for infringement of a process patent by importing the product when the process is carried on outside the jurisdiction?

A party infringes a process patent by importing a product made by the process even if the process was performed outside of the United States. In district court litigation, a party may avoid liability if the product is materially changed before importation or is a trivial part

jury. Jury trials, however, are not available in the following situations: (1) a trial regarding the right to sell generic pharmaceuticals before the expiration of the branded pharmaceutical patent; and (2) ITC investigations. A trial before a judge (without a jury) is called a “bench trial”.Trials begin with opening statements that provide a road map of what each party will show through evidence. Parties then present the evidence through fact and expert witnesses, subject to cross-examination. The scope of expert testimony is limited to the scope of a written report provided ahead of trial. Depending on the issues being tried, the parties may reach agreement with the court as to the order in which the evidence is introduced. Each party ends its presentation with a closing argument. Because patent infringement cases may be highly technical, this is often an opportunity to explain to the jury how the evidence supports each party’s theories. Opening and closing statements themselves are not considered evidence. Although the general theories must be developed and disclosed before trial, the court may allow a party to amend its pleadings before trial for good cause and in exceptional circumstances.

1.6 How long does the trial generally last and how long is it before a judgment is made available?

Trial length varies greatly depending on each case. Jury deliberations happen immediately after the trial is finished, and may last a few hours or several days. After a verdict, the judge entertains the parties’ post-trial motions. For bench trials, the judge will typically issue a written opinion explaining his decision in the weeks or months following trial. Judgments are entered after post-trial motions are decided.Protective orders, agreed upon by the parties and approved by the court, that govern how confidential information is handled during the litigation, are common. Generally, trials in district courts are open to the public, but the parties may request to have the courtroom sealed to avoid disclosure of confidential information in special circumstances. Proceedings before the ITC are open to the public but can more easily be conducted in confidence than in a district court. Judgments from district courts and the ITC are available to the public. The parties may request the judgment to be kept off the public record for some period of time after it is issued, to allow the parties a chance to redact confidential information. A redacted version is subsequently made available to the public.

1.7 Are judgments made available to the public? If not as a matter of course, can third parties request copies of the judgment?

Judgments from district courts and the ITC are available to the public. The parties may request the judgment to be kept off the public record for some period of time after it is issued, to allow the parties a chance to redact confidential information. A redacted version is subsequently made available to the public.

1.8 Are there specialist judges or hearing officers, and if so, do they have a technical background?

District court and ITC judges are not required to have technical backgrounds. Because patent litigation is concentrated in a small number of courts, however, it is common to appear before a judge with extensive experience in patent law. Administrative judges at the ITC, on the other hand, have developed substantial patent

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1.18 Are (i) preliminary, and (ii) final injunctions available, and if so, on what basis in each case? Is there a requirement for a bond?

A party may receive a preliminary injunction if it establishes a substantial likelihood of prevailing on the merits, irreparable harm, a balance of hardship favouring the moving party, and that the injunction will further the public interest.A permanent injunction is available when a party establishes that it will suffer an irreparable injury, that damages are inadequate to compensate for that injury, that the balance of hardships between the parties favours the movant, and that the public interest would not be disserved. Generally, a court may issue an injunction only if the movant posts a bond sufficient to pay the costs and damages sustained by any party that is later found to have been wrongfully enjoined.

1.19 On what basis are damages or an account of profits assessed?

If a patent claim is found to be valid and infringed, a court awards the patentee damages adequate to compensate for the infringement. A patentee may obtain lost profits if it can prove a demand for the patented invention, an absence of acceptable, non-infringing substitutes for the patented invention, that the patentee had the capacity to exploit the demand, and the amount of profit the patentee would have made but for the infringement. The factors to determine lost profits are known as the Panduit factors. A reasonable royalty is calculated using a set of 15 considerations aimed at determining a rate that reasonable parties would have agreed upon at the time of the infringement, commonly known as the Georgia-Pacific factors.

1.20 How are orders of the court enforced (whether they be for an injunction, an award of damages or for any other relief)?

If a party fails to comply with a court order, including an injunction or award of damages, it may be held in contempt by the court upon motion by an opposing party. Upon holding a party in contempt, the court has the power to levy a fine on that party and/or order the United States Marshals Service to enforce the order through, for example, asset seizure. At the ITC, exclusion orders, preventing the importation of the accused products into the United States, are enforced by the U.S. Customs and Border Protection agency.

1.21 What other form of relief can be obtained for patent infringement? Would the tribunal consider granting cross-border relief?

District courts have the power to grant a patentee damages (reasonable royalty or lost profits) upon a ruling that at least one asserted patent claim is valid and infringed. The court may enhance damages as a punitive measure for willful infringement. In rare circumstances, reasonable attorneys’ fees may be granted.The ITC also has the power to issue exclusion orders that prevent the sale for importation, importation, or sale after importation of infringing products into the United States. It may also issue cease and desist orders preventing, among other things, the sale of accused products from existing inventory in the United States.

of another unpatented product. Such an exception is not available in an ITC investigation.

1.13 Does the scope of protection of a patent claim extend to non-literal equivalents?

The “doctrine of equivalents” extends infringement liability to products and processes that do not literally infringe on a patent’s claims, where there is equivalence between the elements. The “doctrine of prosecution history estoppel” may limit the equivalents available to the plaintiff, by precluding the recapture of subject matter surrendered during prosecution.

1.14 Can a defence of patent invalidity be raised, and if so, how? Are there restrictions on such a defence e.g. where there is a pending opposition?

A party may defend against patent infringement by challenging the validity of the patent. Invalidity can be raised as an affirmative counterclaim or in response to a plaintiff’s infringement claim.A party may also seek to invalidate the asserted patent at the PTAB during or before litigation, subject to certain time bars post-service of the complaint on the defendant. PTAB proceedings may be preferred to district court invalidation actions because of their speed and relative cost-efficiency. Arguments raised at the PTAB may have an estoppel effect in later litigation.

1.15 Other than lack of novelty and inventive step, what are the grounds for invalidity of a patent?

In litigation, the validity of a U.S. patent can also be challenged for failure to claim eligible subject matter and/or for failure to provide adequate description (i.e., written description support, definiteness, and enablement).

1.16 Are infringement proceedings stayed pending resolution of validity in another court or the Patent Office?

District courts may stay litigation pending PTAB proceedings or related litigations involving the patent. To determine if a stay is appropriate, district courts consider: whether a stay will unduly prejudice or present a clear tactical disadvantage to the non-moving party; whether a stay will simplify the issues; and whether discovery is complete and a trial date has been set. If an ITC investigation is ongoing, an accused infringer can request, as a matter of right, a stay of the parallel district court action. Due to the rapid pace of ITC proceedings, stays pending PTAB proceedings are not routinely granted at the ITC.

1.17 What other grounds of defence can be raised in addition to non-infringement or invalidity?

Additional defences in a patent infringement litigation include defences that render the patent unenforceable, those being inequitable conduct (misleading the Patent Office) and patent misuse (typically through improper licensing practices), as well as equitable estoppel (reliance on a plaintiff’s conduct). Certain defences, such as failure to keep patents that are subject to a terminal disclaimer together, can also be raised.

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surrender the original patent. Ex parte reexamination can only be based on patents or printed publications that raise a substantial new question of patentability. Supplemental examination can seek to correct any error and the resulting expanded ex parte reexamination is not limited to patents and printed publications.

2.2 Can a patent be amended in inter partes revocation/invalidity proceedings?

Patentees may be able to replace a claim that has been deemed unpatentable during inter partes post-grant challenge (IPR, PGR, CBM), by filing a contingent motion to replace the claims. Thus, while the motion must be made before a final decision on patentability is reached, the PTAB will not consider the motion unless a claim has been deemed unpatentable.

2.3 Are there any constraints upon the amendments that may be made?

In inter partes challenges, proposed claims in a motion to amend must not be broader than the original claims, must have written description support, and be patentable over the prior art.Patents under ex parte reexamination can be amended in response to an Office Action. Although amendments will be entered for purposes of examination, the amendments are not legally effective until the reexamination certificate is issued and published.Patentees may only add new subject matter to their patents through reissue within two years of the issue date. After this two-year mark, no new subject matter may be added to an issued patent through amendments.

3 Licensing

3.1 Are there any laws which limit the terms upon which parties may agree a patent licence?

Patent licensing is policed through federal common law and antitrust statutes. Licensors of patents must offer fair, reasonable, and non-discriminatory rates. Courts have limited licensing agreements to prevent anti-competitive practices (product tying, price fixing, etc.). The United States Federal Trade Commission (“FTC”), charged with enforcing federal antitrust laws, has issued additional guidelines on its expectations of licence agreements.

3.2 Can a patent be the subject of a compulsory licence, and if so, how are the terms settled and how common is this type of licence?

Compulsory licences are rarely granted by U.S. courts. They may be granted in cases of bad faith. Additionally, inventions made with U.S. Government resources or funding are subject to a non-exclusive, non-transferable, irrevocable, paid-up licence to practise, or have practised for or on behalf of the United States, the invention throughout the world.

4 Patent Term Extension

4.1 Can the term of a patent be extended, and if so, (i) on what grounds, and (ii) for how long?

In the United States, patent term adjustment refers to additional time

1.22 How common is settlement of infringement proceedings prior to trial?

Settlements of patent infringement proceedings are very common. Roughly 75% of patent infringement cases terminated in 2016 were settled.

1.23 After what period is a claim for patent infringement time-barred?

Claims for patent infringement are not time-barred in the United States. A patentee, however, may not recover damages for acts of infringement which occurred more than six years before the filing of an infringement action.

1.24 Is there a right of appeal from a first instance judgment, and if so, is it a right to contest all aspects of the judgment?

If a party raised an issue during proceedings at a district court or the ITC, the judgment may be appealed to the Federal Circuit. The Federal Circuit has exclusive jurisdiction over patent appeals. Federal Circuit decisions are not appealable as a matter of right, but are reviewed on a discretionary basis by a full panel of the Federal Circuit or, rarely, by the U.S. Supreme Court.

1.25 What are the typical costs of proceedings to first instance judgment on (i) infringement, and (ii) validity? How much of such costs are recoverable from the losing party?

Patent litigation costs are dependent upon a variety of factors including technical complexity, number of parties involved, law firms involved, geographic location, and amount in controversy. The American Intellectual Property Law Association releases a biennial report on the average costs of patent litigation. Each party bears its own litigation expenses, but reasonable attorneys’ fees may be awarded to a prevailing party if the case is deemed exceptional under the relevant statute.

1.26 For jurisdictions within the European Union: What steps are being taken in your jurisdiction towards ratifying the Agreement on a Unified Patent Court, implementing the Unitary Patent Regulation (EU Regulation No. 1257/2012) and preparing for the unitary patent package? For jurisdictions outside of the European Union: Are there any mutual recognition of judgments arrangements relating to patents, whether formal or informal, that apply in your jurisdiction?

This is not applicable.

2 Patent Amendment

2.1 Can a patent be amended ex parte after grant, and if so, how?

Corrections that do not affect the scope of the claims may be made through a certificate of correction. Substantive changes/corrections can only be made through a reissue, ex parte reexamination, or supplemental examination. Reissue requires the patentee to state that the patent is wholly or partly inoperative or invalid, and offer to

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inventor, or whether the invention was “derived” from another party (i.e., independence of invention is questioned). Pre-AIA patents and applications may still be subject to interference proceedings at the USPTO. In these proceedings, the question is which of the parties claiming the subject matter invented it first (i.e., independence of invention is presumed).

5.6 Is there a “grace period” in your jurisdiction, and if so, how long is it?

For applications filed on or after March 16, 2013, a one-year grace period exists from the first disclosure by the inventor (or someone who learned of the invention from the inventor) to the application’s filing date. For applications filed before March 16, 2013, the grace period is one year before the patent application is filed.

5.7 What is the term of a patent?

In general, the term for utility patents, filed after June 8, 1995, is 20 years from the earliest filing date of the application to which the patent claims priority. For utility applications filed before June 8, 1995, the patent term is either 17 years from the issue date or 20 years from the filing date, whichever is longer. Extensions, as explained in question 5.1, can enlarge the patent term. The term of a patent can also be shortened by prosecution terminal disclaimers (often filed to obviate double-patenting rejections), or when the maintenance fees are not timely paid.

6 Border Control Measures

6.1 Is there any mechanism for seizing or preventing the importation of infringing products, and if so, how quickly are such measures resolved?

A party may seek an exclusion order from the ITC. When an exclusion order goes into effect, U.S. Customs and Border Protection will bar the infringing product from entering the United States. The ITC administrative judges will typically issue an initial determination within 12 months of an investigation being initiated. The final decision may then be reviewed by the full Commission, and then, after Presidential Review, potentially by the Federal Circuit.

7 Antitrust Law and Inequitable Conduct

7.1 Can antitrust law be deployed to prevent relief for patent infringement being granted?

Patent misuse is an affirmative defence based on a patentee’s abuse of the exclusive rights conferred by a patent. Patent misuse can only be used by an alleged infringer if and when the patentee seeks to enforce the exclusive right of the patent in a patent infringement suit. If a party is found to have committed an antitrust violation in connection with the exercise of its patent rights, the patent may be deemed unenforceable, and preclude the patentee from asserting infringement of it.

7.2 What limitations are put on patent licensing due to antitrust law?

Antitrust violations are often committed when a patentee attempts to extend the exclusionary rights granted by the patent through the

added to the patent term due to processing delays caused by the USPTO. The amount of time added is determined by the USPTO and is not limited by statute. The U.S. Food and Drug Administration (“FDA”) may also grant patent term extension by up to five years for certain pharmaceuticals or medical devices whose market entry has been delayed by the FDA’s safety review of the patented products.

5 Patent Prosecution and Opposition

5.1 Are all types of subject matter patentable, and if not, what types are excluded?

Generally, the United States grants patents to new and useful processes, machines, manufactures, and compositions of matter. It does not grant patents directed to laws of nature, natural phenomena, or abstract ideas. While subject matter eligibility is codified in the patent statute 35 U.S.C. § 101, its interpretation by the courts is a hot topic in the United States these days. Recent major decisions in this area include Mayo v. Prometheus and Alice Corp. v. CLS Bank.

5.2 Is there a duty to the Patent Office to disclose prejudicial prior disclosures or documents? If so, what are the consequences of failure to comply with the duty?

All individuals associated with the prosecution of a patent application have a duty to disclose information material to patentability to the USPTO. Failure to comply with the duty of disclosure may result in the USPTO’s refusal to grant a patent, or give rise to an inequitable conduct challenge in litigation.

5.3 May the grant of a patent by the Patent Office be opposed by a third party, and if so, when can this be done?

Third parties may submit observations before the earlier of the date of a notice of allowance, or the later of six months after the patent application is first published or the date of the first rejection of any claim by the examiner. The submission must be of potential relevance to the examination of the application and include a statement of the asserted relevance of each submitted item. After the patent is granted, the PTAB proceedings described in the answer to question 1.9 may be brought.

5.4 Is there a right of appeal from a decision of the Patent Office, and if so, to whom?

There is a statutory right to appeal of USPTO decisions. Applicants may seek review of an examiner’s decision within the PTAB. In turn, PTAB decisions may be appealed to the U.S. District Court for the Eastern District of Virginia, or to the Federal Circuit.

5.5 How are disputes over entitlement to priority and ownership of the invention resolved?

The America Invents Act (“AIA”) moved the U.S. patent system from first-to-invent to first-to-file. Thus, under the AIA when two parties independently invent the same subject matter, the one who files first gets the patent. Post-AIA, derivation procedures are used to resolve disputes when two parties claim the same invention, and there is a dispute as to whether the first to file was the actual

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8.3 Are there any general practice or enforcement trends that have become apparent in your jurisdiction over the last year or so?

The year 2016 showed a 20% decline in patent infringement cases when compared with 2015. The Eastern District of Texas, the District of Delaware, and the Central District of California handled the highest number of patent infringement cases. It is expected that in the wake of TC Heartland, the number of patent cases litigated in the Eastern District of Texas, a sought-after venue for its efficient docket, may decrease. Opinions of counsel on non-infringement as a defence to allegations of willful infringement, in the wake Halo v. Pulse Electronics, which relaxed the standard patentees need to meet to make allegations of willful infringement, have become more popular and relied-upon at trial to defend against willfulness allegations. The filing of IPRs and PGRs has increased since 2015. Overall, the majority of PTAB proceedings settle, with only about 18% proceeding to completion. The Federal Circuit has reversed and remanded more IPR decisions over the past year. Through March 1, 2017, the Federal Circuit decided 172 PTAB appeals from IPRs and CBMs. The Federal Circuit affirmed the PTAB on every issue in 76% cases and reversed in about 8%. A mixed outcome on appeal, where at least one issue was affirmed and at least one issue was vacated or reversed, occurred in 9% of cases.

AcknowledgmentThe authors would like to thank Alexander Poonai for his assistance in preparing this chapter. Mr. Poonai is a juris doctor candidate at the George Washington University Law School and a summer associate at Finnegan.

imposition of additional contractual restrictions on the invention’s use. The courts have restricted a number of such anti-competitive restrictions, including tying, patent pooling, and post-expiration royalties.

8 Current Developments

8.1 What have been the significant developments in relation to patents in the last year?

TC Heartland limited the forums in which patent litigation may be brought, by limiting the venue to where the accused infringer is incorporated, or where the infringement occurred and the accused infringer has a regular place of business.In SCA Hygiene Products, the Court held that the equitable doctrine of laches cannot be invoked as a defence against a claim for damages incurred within the six-year statutory limitation period. In Lexmark, the Court held that, when a patentee sells a product, the sale exhausts all patent rights in the item being sold regardless of any restrictions the patentee attempts to impose on the location of the sale.

8.2 Are there any significant developments expected in the next year?

In Oil States v. Greene’s Energy Group, the Supreme Court will decide whether IPRs violate the constitutional rights of patentees by extinguishing their private property rights without a jury. Although the patent review proceedings are relatively new, the PTAB has become a preferred venue to challenge the validity of patents outside of district courts. A decision holding IPRs unconstitutional could alter the current landscape of patent litigation by shifting the bulk of invalidity challenges back to the courts.

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Mareesa A. Frederick Finnegan, Henderson, Farabow, Garrett, and Dunner LLP901 New York Avenue NWWashington, D.C. 20001-4413USA

Tel: +1 202 408 4000Email: [email protected]: www.finnegan.com

Clara N. JiménezFinnegan, Henderson, Farabow, Garrett, and Dunner LLP901 New York Avenue NWWashington, D.C. 20001-4413USA

Tel: +1 202 408 4000Email: [email protected]: www.finnegan.com

Mareesa A. Frederick is a Partner at Finnegan’s Washington, D.C. office. Her practice focuses on client counselling, opinion work, and patent and other intellectual property litigation with a particular emphasis on Section 337 proceedings before the International Trade Commission (“ITC”). Prior to rejoining the firm, Ms. Frederick was a senior investigative attorney at the ITC and served as lead government counsel in a number of Section 337 cases before the ITC involving patents for mechanical, electrical, and consumer products. Ms. Frederick is experienced in developing trial strategies, analysing patents and technical issues, preparing pleadings, taking depositions of fact witnesses, assisting technical experts in their preparation of expert reports, conducting depositions of expert witnesses, examining witnesses at trial, and preparing briefs and motion papers. In addition to her patent practice at Finnegan, Ms. Frederick has served as an adjunct professor at Howard University for six years, teaching patent law to engineering students.

Finnegan, Henderson, Farabow, Garrett & Dunner, LLP is one of the largest IP law firms in the world. From offices in Atlanta, Boston, London, Palo Alto, Reston, Seoul, Shanghai, Taipei, Tokyo, and Washington, D.C., the firm practises all aspects of patent, trademark, copyright, and trade secret law, including counselling, prosecution, licensing, and litigation. Finnegan also represents clients on IP issues related to European patents and trademarks, international trade, portfolio management, the Internet, e-commerce, government contracts, antitrust, and unfair competition. For additional information on the firm, please visit www.finnegan.com.

Clara N. Jiménez counsels clients in the chemical and medical device industries. She has experience with a broad range of technologies, including: consumer, industrial, and pharmaceuticals products; polymers, catalysts, metallurgical, and advanced materials; cosmetics, printing inks, oil and gas, batteries, and industrial manufacturing. Ms. Jiménez’s practice encompasses patent prosecution, client counselling, post-grant practice, and patent litigation. Ms. Jiménez drafts and prosecutes U.S. patent applications, coordinates foreign patent prosecution, and assists clients in the development of trade secret policies. In addition, Ms. Jiménez has experience in reexamination, interference, and inter partes review proceedings before the U.S. Patent and Trademark Office. She also represents patentees and accused infringers in litigation before U.S. district courts. Ms. Jiménez advises clients in formulating cohesive strategies to assert and defend their rights in patent infringement and invalidation proceedings in Europe, South America, and Asia.

USAFinnegan, Henderson, Farabow, Garrett, and Dunner LLP

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Chapter 33

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Vietnam

1.3 Can a party be compelled to disclose relevant documents or materials to its adversary either before or after commencing proceedings, and if so, how?

The mechanism of discovery of evidence does not exist in Vietnam. However, for collecting evidence that is under the control of the other party, either the plaintiff or defendant has the right to request the court to compel the party to produce such evidence. Art. 58.2.d) of the Civil Procedure Code regulates that the involved parties shall have the right “to read and take notes, photocopy documents and/or evidences produced by other involved parties or collected by courts” when participating in civil procedures.In case of infringement of a patented process, the defendant is compelled to show evidence to prove that his or her products are made by a process other than the patented process.

1.4 What are the steps each party must take pre-trial? Is any technical evidence produced, and if so, how?

There is no specific pre-trial procedure, it is up to the parties to prepare any evidence, including pleadings, reports, witness statements, experts (technical), they consider necessary for proving their case. Concerned parties have the right to request that the court provides them with the evidence submitted by the other party. When deeming it necessary, the Trial Panels may arrange for audio tapes and/or discs to be heard, and/or video tapes and/or discs to be screened at court sessions, except for cases in which it is necessary: to keep State secrets; to preserve the nation’s fine customs and practices; to keep professional secrets, business secrets or private secrets at the requests of the involved parties; or go together with the involved parties for on-site examination of exhibits which cannot be brought to court sessions.

1.5 How are arguments and evidence presented at the trial? Can a party change its pleaded arguments before and/or at trial?

In general, a lawsuit petition is filed together with documents and/or evidences and an explanation sheet to prove that the claim(s) of a litigator are well grounded and lawful. Arguments are presented orally to the judging panel at the trial.The judging panel would consider evidences, photographs and records of confirmation of evidences at the trial.If necessary, the judging panel shall arrange for the listening of audio tapes and discs and screening of video tapes and discs during the trial.

1 Patent Enforcement

1.1 Before what tribunals can a patent be enforced against an infringer? Is there a choice between tribunals and what would influence a claimant’s choice?

Vietnam has no specialised IP court. Patent owners may enforce their IP rights by initiating civil litigations before Civil Courts, which are called People’s Courts, of provinces or centrally-run cities. A defendant’s domicile, workplace or place of his/her head office, or the locality of the infringement, would determine the court that has jurisdiction over a case.

1.2 What has to be done to commence proceedings, what court fees have to be paid and how long does it generally take for proceedings to reach trial from commencement?

Before commencing proceedings in the court, it is common for a letter of demand to be first sent to an alleged infringer in an attempt to reach a resolution of the dispute without the need for court action. If no resolution can be reached, a legal action is commenced with the filing of the plaintiff’s complaint with a competent court. A request for applying provisional measures may be submitted at the time of filing the petition or during the settlement of the case.The court would officially accept the case after the applicant submits a receipt for the payment of court costs and/or court fees as regulated in Decision No.326/2016/UBTVQH14 dated December 30, 2016 of Standing Committee of the National Assembly on Court Costs and Fees. At this time, concerned parties have the right and obligation to lodge requested opinions and evidence with the court. The court may collect or request relevant authorities to collect evidence concerned upon the request of either the plaintiff or defendant.The time limit for pre-trial procedural stages ranges from two to four months. The court may decide to extend the time limit for preparation for the trial, but it shall not exceed six months in any case. However, in practice, the first-instance trial often lasts from 12 months to 18 months. During the period of the pre-trial procedural stage for a trial at first instance, the court shall carry out conciliation to enable the parties to reach an agreement on the settlement of the case. If negotiation between the parties fails, the court shall issue a decision to bring the case to a hearing.A first-instance trial must be conducted within one month from issuing the decision to hear the case.

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1.12 Can a party be liable for infringement of a process patent by importing the product when the process is carried on outside the jurisdiction?

Yes. A party can be liable for infringement of a process patent by importing the product when the process is carried on outside the jurisdiction.

1.13 Does the scope of protection of a patent claim extend to non-literal equivalents?

Yes. “Equivalents” of the claimed subject liable for infringement covers both product and process. In particular, an infringing element of an invention may take any of the following forms:(i) a product or part (component) of a product which is identical

or equivalent to a product or part (component) of a product within the scope of protection as an invention;

(ii) the process is identical or equivalent to a process that is protected as an invention; or

(iii) the product or part (component) of the product is manufactured via a process that is identical or equivalent to a process currently protected as an invention.

1.14 Can a defence of patent invalidity be raised, and if so, how? Are there restrictions on such a defence e.g. where there is a pending opposition?

A defence of patent invalidity can be raised (see question 1.16 below). There are restrictions on such defence, for instance, the court can stay the infringement proceedings pending the opposition proceedings settled by NOIP.

1.15 Other than lack of novelty and inventive step, what are the grounds for invalidity of a patent?

Other grounds for invalidity of a patent comprise:(i) the subject matter lacks industrial applicability;(ii) the subject matter is unpatentable (see question 5.1); and(iii) the patentee was not entitled to file the application for the

subject matter.

1.16 Are infringement proceedings stayed pending resolution of validity in another court or the Patent Office?

The court may decide to temporarily suspend the civil lawsuit while the resolution of validity is in progress.

1.17 What other grounds of defence can be raised in addition to non-infringement or invalidity?

The other grounds of defence that can be raised, apart from non-infringement or invalidity, are:(i) using the subject of the patent for personal needs or non-

commercial purposes, or for the purposes of evaluations, analysis, research, education, testing, pilot production or for collecting information to carry out procedures to obtain a production licence, import or product marketing permit;

(ii) circulating, importing or exploiting the products having been legally put into the market, including foreign markets;

A party can change its pleaded arguments and/or make additional comments at trial provided that the changes to the arguments are based on documents and evidence that has been collected, examined and verified at court sessions, as well as results of the inquiring process at court sessions.

1.6 How long does the trial generally last and how long is it before a judgment is made available?

The trial hearing can last one or several days depending on the complexity of the case.The judgment is often pronounced right after the hearing. Within a time-limit of 10 days from the date of pronouncement of the judgment, the court shall deliver or forward the judgment to the concerned parties.

1.7 Are judgments made available to the public? If not as a matter of course, can third parties request copies of the judgment?

Yes. Judgments are made available to the public. According to Resolution No. 03/2017/NQ-HDTP dated February 17, 2017 of the Judicial Council of the Supreme People’s Court, judgments and decisions of courts will be published on the Court’s web portal within 30 days from the date on which such judgments, decisions take effect. This Resolution came into effect from July 1, 2017.

1.8 Are there specialist judges or hearing officers, and if so, do they have a technical background?

No. There are no specialised intellectual property courts or specialist judges in the People’s Court.

1.9 What interest must a party have to bring (i) infringement, (ii) revocation, and (iii) declaratory proceedings?

(i) The plaintiff must be the owner of the patent, or an exclusive licensee with proper licensing recordation at the NOIP.

(ii) Any party is entitled to request the NOIP to take a patent revocation if: (a) the applicant for the patent neither has the right to file the application nor has been assigned such right; and (b) the subject matter of industrial property failed to satisfy the protection conditions at the grant date of the patent.

(iii) Declaratory proceedings are not applicable in this jurisdiction.

1.10 If declarations are available, can they address (i) non-infringement, and/or (ii) claim coverage over a technical standard or hypothetical activity?

Declarations are not available in Vietnam.

1.11 Can a party be liable for infringement as a secondary (as opposed to primary) infringer? Can a party infringe by supplying part of, but not all of, the infringing product or process?

No. There is no secondary/contributory infringement provided for under Vietnamese law.

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enforcement, provided that agreement does not violate prohibitions prescribed by law and is not contrary to social morality. Outcomes of judgment enforcement under agreements will be recognised. The State encourages involved parties to voluntarily execute judgments. The time limit for voluntary execution of a judgment is 15 days after the judgment debtor receives, or is properly notified of, the judgment enforcement decision. Upon the expiration of this time limit, judgment debtors with judgment execution conditions who fail to voluntarily execute judgments shall be coerced to do so.

1.21 What other form of relief can be obtained for patent infringement? Would the tribunal consider granting cross-border relief?

The court may order: (i) ceasing of the infringing act; (ii) public rectification and apology; (iii) performance of civil obligations; (iv) compensation of damages; and (v) destruction or disposal of infringing goods for non-commercial purposes. Cross-border relief is irrelevant to Vietnam and therefore is not applicable.

1.22 How common is settlement of infringement proceedings prior to trial?

In principle, the settlement of patent infringement proceedings before trial in Vietnam can be reached via arbitration, mediation or conciliation procedures. However, in practice, an arbitration deals with disputes arising from a contract, but not from a patent infringement, while mediation is not a popular approach for settlement of patent infringement in similar cases. As a result, the parties concerned often reach a settlement prior to trial by conciliation, and followed by the withdrawal of the statement of claims filed by the plaintiff. In addition, administrative actions are a common measure to act against IP infringement in Vietnam. Such an administrative action is able to help the IP owner to obtain sufficient evidence materials not only for a follow-up settlement negotiation, but also for a possible civil action initiated by the IP owner. In many cases, a settlement is reached after an administrative raid, without initiating a civil action against the infringer.

1.23 After what period is a claim for patent infringement time-barred?

The statute of limitation for initiating a lawsuit against infringement is two years from the date the infringement is discovered or from the date on which legitimate rights and interests of individuals/organisations are infringed.

1.24 Is there a right of appeal from a first instance judgment, and if so, is it a right to contest all aspects of the judgment?

Concerned parties have the right to appeal the first instance judgment to a higher court and contest a part or all aspects of the judgment.

1.25 What are the typical costs of proceedings to first instance judgment on (i) infringement, and (ii) validity? How much of such costs are recoverable from the losing party?

The costs are calculated on a case-by-case basis, depending on the complexity of the case, etc.

(iii) using the subject of the patent only for the purpose of maintaining the operation of a foreign vehicle in transit or only temporarily entering into the territory of Vietnam;

(iv) using the subject of the patent by the person with prior user right; and

(v) using the invention by the person authorised by the competent State authority in case of a compulsory licence.

1.18 Are (i) preliminary, and (ii) final injunctions available, and if so, on what basis in each case? Is there a requirement for a bond?

(i) Preliminary injunctions are available at the court’s discretion. The petitioner must prove that the alleged infringement is likely to cause irreparable damage or the product suspected of infringing the patent rights or relevant evidences is likely to be destroyed, if not protected. The preliminary injunctions must be secured by a bond of 20% of the value of the goods that are subject to the application of provisional measures, or at least VND20 million if it is unable to determine the value of those goods, or a guarantee document issued by a bank or other credit organisations.

(ii) A court judgment that comes into force shall become a final injunction. The court judgment of the first instance trial will be enforceable if it is not appealed to the People’s Supreme Court.

The judgment of the appellate court shall be legally enforceable as of the date of the pronouncement of the judgment.

1.19 On what basis are damages or an account of profits assessed?

Art. 2014 of the IP Law provides the rules on determination of damages, which consist of material damages (i.e., property loss, income and profit decrease, loss of business opportunity, etc.) and spiritual damages (i.e., damage to honour, dignity, prestige and reputation, etc.) caused by infringement of intellectual property rights. The burden of proving and calculating material damages lies with the plaintiff. Damages/compensation can be calculated on the following grounds:(i) The equivalent in money of the total physical damage caused,

plus the profits gained by the dependant from the act of infringement if the reduced profits of the plaintiff have not yet been included in the total physical damage.

(ii) The value of the presumption that the defendant has been licensed by the plaintiff under a licence contract, to the extent that is equivalent to the infringing act committed.

(iii) Where it is unable to determine the rate of compensation, compensation shall be fixed by the court but shall not exceed VND500 million.

(iv) Where the plaintiff succeeds in proving that the act of infringement has caused spiritual damage to him or her, he or she shall have the right to request the court determines the rate of compensation ranging from VND5 million to VND50 million, depending on the level of damage.

1.20 How are orders of the court enforced (whether they be for an injunction, an award of damages or for any other relief)?

Within five years after a judgment or ruling takes legal effect, the judgment creditor and judgment debtor may request a competent civil judgment enforcement agency to issue a judgment enforcement decision. Involved parties may reach agreement on judgment

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to the licensor the right to improvements of the licensed object.

(ii) Directly or indirectly restricting the licensee from exporting goods produced under the industrial property object licence contract to territories where the licensor neither holds the respective industrial property right, nor has the exclusive right to import such goods.

(iii) Compelling the licensee to buy all or a certain proportion of materials, components or equipment from the licensor or the persons designated by the licensor without aiming at ensuring the quality of goods produced or services supplied by the licensee.

(iv) Prohibiting the licensee from complaining about the validity of the industrial property right or the right to licence of the licensor.

3.2 Can a patent be the subject of a compulsory licence, and if so, how are the terms settled and how common is this type of licence?

Yes. A patent can be subject to a compulsory licence. However, to the best of our knowledge, none have been granted in Vietnam till now.Compulsory licences can be granted if:(i) the use of the invention is in the public interest, or for non-

commercial purposes, national defence, security, disease prevention and treatment, nutrition for people, or meeting other urgent needs of society;

(ii) the exclusive patent right holder fails to fulfil the obligation of using the invention after the expiration of four years from the date of filing of the patent application and the expiration of three years from the granting date of the Patent for Invention;

(iii) the person who wants to use the invention fails, despite efforts made within a reasonable period of time for negotiation on reasonable considerations and commercial conditions, to reach an agreement with the exclusive patent right holder upon the conclusion of a patent licence contract; and/or

(iv) the exclusive patent right holder is determined to perform an act of anti-competition prohibited under the laws and regulations on competition.

Upon a request of any individual or organisation, the Ministry of Science and Technology (MOST) or other relevant ministries under the guidance of the MOST may grant a compulsory licence.The IP Law does not provide a specific term for such licences, leaving it at the MOST’s discretion.

4 Patent Term Extension

4.1 Can the term of a patent be extended, and if so, (i) on what grounds, and (ii) for how long?

The term of a patent cannot be extended in any way.

5 Patent Prosecution and Opposition

5.1 Are all types of subject matter patentable, and if not, what types are excluded?

In accordance with Art. 59 of the Vietnam IP Law:“The following subject matter shall not be protected as inventions:■ discoveries, scientific theories, mathematical methods;

Regarding a civil lawsuit, attorneys’ fees are estimated at about US$10,000 and are charged based on the work undertaken.The winning party can recover these costs to the extent depending on its claim for damages. The claim for damages must be calculated on the damage incurred by the party.

1.26 For jurisdictions within the European Union: What steps are being taken in your jurisdiction towards ratifying the Agreement on a Unified Patent Court, implementing the Unitary Patent Regulation (EU Regulation No. 1257/2012) and preparing for the unitary patent package? For jurisdictions outside of the European Union: Are there any mutual recognition of judgments arrangements relating to patents, whether formal or informal, that apply in your jurisdiction?

Vietnam has no mutual recognition of judgments arrangements relating to patents, whether formal or informal, with any country or regional organisation. However, results of substantive patent examination conducted by the following entities: (i) the International Searching Authorities and International

Preliminary Examining Authorities under the PCT; and(ii) the patent offices of: the United States; Canada; Japan; the

Russian Federation; the United Kingdom; Sweden; Spain; Australia; China; the Republic of Korea; Germany; the European Patent Office; and the Eurasian Patent Organization (EAPO),

might be considered as a basis for granting a patent in Vietnam.

2 Patent Amendment

2.1 Can a patent be amended ex parte after grant, and if so, how?

A voluntary amendment may be requested by the patent owner in order to narrow the scope of the granted patent.

2.2 Can a patent be amended in inter partes revocation/invalidity proceedings?

During revocation/invalidity proceedings before the court or during opposition proceedings before the NOIP, the scope of the granted patent can be narrowed by cancelling one or more claims.

2.3 Are there any constraints upon the amendments that may be made?

A granted patent can only be amended by cancelling one or more claims. Rewording the claims is not allowed.

3 Licensing

3.1 Are there any laws which limit the terms upon which parties may agree a patent licence?

Yes. Limitation of the terms upon which parties may agree a patent licence is mainly provided for in the IP Law. The following matters must not be included in the licence agreement:(i) Prohibiting the licensee from improving the licensed object,

or compelling the licensee to grant a free licence or to assign

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presentation; and (iii) it was exhibited at a national exhibition of Vietnam or at an official or officially recognised international exhibition, without permission of the person having the right to registration as provided for in Art. 86 of the IP Law.

5.7 What is the term of a patent?

A patent for invention shall expire 20 years after the filing date, while a patent for utility solution shall expire 10 years after the filing date.

6 Border Control Measures

6.1 Is there any mechanism for seizing or preventing the importation of infringing products, and if so, how quickly are such measures resolved?

The patentee can request that Customs suspend the suspected infringing goods. At the same time as filing the request, the patentee or its representative must submit a deposit bond or bank guarantee at an amount equal to 20% of the value of the goods that are subject to detention, or VND20 million, if the total value of the goods cannot be gauged.Upon receiving the request and the bond (or bank guarantee), Customs is entitled to grant a decision on suspension of Customs clearance of the requested goods in 10 working days from the day the patentee or its representative receives the decision. This time limit can be extended for a further 10 days if necessary. Within the prescribed time-limit for suspension, the patentee should consolidate its allegation and proceed with possible actions, including: initiating a civil lawsuit against the owner of the detained goods; requesting Customs take administrative actions against the owner of the detained goods; or reaching an agreement with the owner of the detained goods.

7 Antitrust Law and Inequitable Conduct

7.1 Can antitrust law be deployed to prevent relief for patent infringement being granted?

There are no specific statutory provisions or lawsuits as a precedent in which patent infringement is denied for a reason of antitrust violation.

7.2 What limitations are put on patent licensing due to antitrust law?

The prevailing Law on Competition, which is known as antitrust law in Vietnam, does not specifically provide for limitations on patent licensing. However, it prohibits the following practices:1. obstruction of technical or technological development by

any enterprise or group of enterprises in a dominant market position; and

2. agreements to restrain technical or technological developments to which the parties have a combined market share of 30% or more of the relevant market (Art. 8 – Agreements in Restraint of Competition).

■ schemes, plans, rules or methods for performing mental acts, training domestic animals, playing games, doing business; computer programs;

■ presentations of information;■ solutions of aesthetic characteristics only;■ plant varieties, animal varieties;■ processes of an essentially biological nature for the production

of plants and animals other than microbiological processes; and

■ disease prevention, diagnostic and treatment methods for human or animals.”

Furthermore, “the intellectual property objects which are contrary to the social morality, public order or are harmful to national defence and security” shall not be protected under Art. 8 of the same law.

5.2 Is there a duty to the Patent Office to disclose prejudicial prior disclosures or documents? If so, what are the consequences of failure to comply with the duty?

No. There is no duty to disclose prejudicial prior disclosures or documents to the NOIP.

5.3 May the grant of a patent by the Patent Office be opposed by a third party, and if so, when can this be done?

Yes. As from the date a patent application is published until the date of the decision on the grant of a patent, any third party may apply to oppose the grant of a patent.The request for opposition must be in writing and specify at least one ground for opposition.

5.4 Is there a right of appeal from a decision of the Patent Office, and if so, to whom?

If dissatisfied with a decision from the NOIP, a petition to appeal must be filed with the Board of Appeal of the NOIP within three months from the date of the decision. If still dissatisfied with the decision on appeal from the Board of Appeal, a further appeal to the MOST can be lodged, or an appeal action can be taken before the competent administrative court.

5.5 How are disputes over entitlement to priority and ownership of the invention resolved?

Disputes over entitlement to priority and ownership of the invention may be resolved by the NOIP. In case the NOIP cannot decide on the matter, the Office will invite the competing parties to institute proceedings before a competent court. The Office will then act in accordance with the court order.

5.6 Is there a “grace period” in your jurisdiction, and if so, how long is it?

Yes, there is a “grace period” in Vietnam and it is six months from the date of publication. During this period, an invention shall not be considered as lacking novelty if it was published under the following circumstances: (i) by another person; (ii) in the form of a scientific

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Pham Vu Khanh ToanPham & Associates8 Tran Hung Dao Street Hoan Kiem District HanoiVietnam

Tel: +84 24 3824 4852Fax: +84 24 3824 4853Email: [email protected]: www.pham.com.vn

Degrees:

B.Sc. in Physics, LL.B. and M.IP.

Qualified:

Attorney at Law (Hanoi, 1997).

Patent and Trademark Attorney (Hanoi, 1988).

Copyright Attorney (Hanoi, 1990).

Areas of practice:

All areas of IP Law.

Career to date:

1991–present: Managing Partner of Pham & Associates.

1988–1991: Partner of INVESTIP – an IP Agency.

1985–1988: Official of the National Office of Intellectual Property (NOIP).

Recent transactions:

Successfully handled a number of complicated cases for Honda, AstraZeneca, Yamaha, Panasonic, Microsoft, Russian Vodka, Perfetti Van Melle S.p.A, Colgate – Palmolive, Acecook Vietnam, Takeda Pharmaceutical, Mitsui Takeda Chemicals, Procter & Gamble, SC Johnson & Son, Abbott Laboratories, Adidas AG.

Professional associations/memberships:

Member of Vietnamese Lawyers Association, APAA, AIPPI, INTA, AIPLA, ECTA, IBA, FICPI, LES and LAWASIA.

Mr. Pham has been periodically invited to give lectures on IP at the law schools and universities in Hanoi and Ho Chi Minh City. He is now Vice-President of the Vietnam Anti-Counterfeit Goods Association and the Ho Chi Minh City Intellectual Property Association.

Founded in 1991, Pham & Associates is a leading IP law firm in Vietnam. With offices in Hanoi, Ho Chi Minh, Da Nang and Hai Phong cities, and a staff of 125, including 62 qualified IP attorneys, attorneys at-law and 28 technical consultants, supported by about 40 professionals from leading universities and R&D institutions and 50 patent and legal translators who can timely and accurately translate patent applications, prior art, foreign references as well as discovery documents related to patent litigation, we work across the country to help our domestic and foreign clients obtain the greatest advantages in prosecution and enforcement of their IP rights in Vietnam and throughout the world. Our professionals work in all technical areas, including chemistry, mechanics, electronics, pharmaceuticals, biotechnology, material science and IT. Since 2001, in addition to IP services, our firm has also provided legal consultancy services on business and investment laws in Vietnam.

8 Current Developments

8.1 What have been the significant developments in relation to patents in the last year?

There were no significant developments in relation to patents in the last year.

8.2 Are there any significant developments expected in the next year?

The Vietnam IP regime is being reviewed to amend the IP Law for the second time, which is planned to take place in 2018. Most eagerly anticipated is transparency in disclosure, which means that the IP authority (NOIP) must endeavour to make available on the Internet its laws, regulations, procedures and administrative rulings of general application concerning the protection and enforcement of IPRs. Specifically, regarding disclosure of patent information, the following information: (a) search and examination results, including details of, or information related to, relevant prior art searches; (b) as appropriate, non-confidential communications from applicants; and (c) patent- and non-patent-related literature citations submitted by applicants and relevant third parties should be disclosed in an adequate and detailed manner, as required in Art. 18.45 of the TPP Agreement, which Vietnam and 11 other countries signed on February 4, 2016. This expectation is truly a challenge for the IP state management agencies, but will bring about practical benefits to both inventors and the public.

8.3 Are there any general practice or enforcement trends that have become apparent in your jurisdiction over the last year or so?

According to Art. 171 (Infringing upon industrial property rights) of the Amended Penal Code 2009, criminal proceedings are no longer available for patent infringements, therefore administrative and/or civil actions are the only alternatives for a patentee to choose from, to protect his/her patent rights. Almost all IP rights infringements were settled by administrative measures; the ratio of these measures to civil actions was about 98% to 2%.

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