Business InformationIn A Global Context

16

8d' International Forum on

Freedomto Operate

Practical Approaches to Obtaining and Maintaining FTO and Interpretingthe Latest Legal and Regulatory Developments

18 & 19 May, 2011

Sofitel MunichBayerpost, Germany

Get Essential Informationfrom the Experts:

The European Patent OfficeActelion

Actogenix

Boxall IPM

De Brauw Blackstone Westbroek

Dechert LLPHarrison Goddard FooteHolnie Patent A/SHowrey LLPJones Day

K & S PartnersKilburn and Strode LLPLiu, Shen & Associates

Medical Research Council TechnologyMerck & Co.

MundipharmaNovo Nordisk AIS

PDG Avocats

Powell Gilbert

Ropes and Gray LLP

Siena Biotech

UCBVéron & Associés

Vossius & Partner

Vertex Pharmaceuticals

Witte, Weller & Partner

Top IP practitioners, experienced in-house counsel and regulatoryexperts will provide you with valuable insight on FTO challengesand updates, including:

Executing successful and cost-effective search strategies

Enforcing or defending patent claims in new markets

Challenging validity to overcome blocking patents

Capitalising on the benefits of Supplementary Protection Certificates

Obtaining market authorisation w diversify your portfolio

Maximising the value of your portfolio through Paediatric Extension

Acquiring data exclusivity to extend your patent protection in Europe

Gaining FTO in emerging markets: a focus on China and India

Implementing a strategy for managing FTO risks of third party patents

The impact of US issues on European FTO analysis

Plus, add practical value to your experience when you attend the programme'spost-conference workshop on:

Reading and Analysing Claims in Patents and Patent Applications: EU and USjurisdiction-specific issues

Gain both practical and strategic insight i nto a wide range of European and US-specificFTO issues that will assist you ro read and analyse patent daims and overcome theever-present barriers of interpretation within rhese key jurisdictions.

Associate Sponsor:R

Media Partners:

II www,PharmCastam-1.1monaterflod heu.-

Gl]A\1 PharmVOICE

Up to n D12.75u r

To register call +44 (0) 20 7878 6888 or register online at www.C5-Online.com/FTO

DAY ONE: 18 MAY, 2011

8.30 Coffee and Registration

9.00 Chair's Opening Remarks

Allen NorrisHead of Group IP, UCB (Belgium)

9.10 Developing and Executing a Successfuland Cost-effective FTO Search Strategy

Marco NievoIP and Scientific Information, Siena Biotech (Italy)

Emma KoncewiczInformation OfficerMedical Research Council Technology (UK)

Sarah Boxai]IP Manager, Boxai! IPM (UK)

Determining at what stage to conduct the FTO search- aligning your search activity with your R&D phases

minimising risks by correctly setting your searchparameters

Outsourcing the search functionwhen is it appropriate to use a search database?outsourcing partners: how to find the right searcherfor a specific classical drug or bio molecule

Classifying and maintaining comprehensive search recordshow to organise and document search results

- identifying and categorising "relevant" data forthe future

Constructing your FTO search strategysearch strategy language: Boolean operators andtruncation, what terms to search?how to mine down ro relevant patent filings and whatterritories they coverhow can Machine-Assisted Translations (MATs) aidyour FTO research?

Developing an effective landscaping strategydefining and determining the landscapecombating market competition and competitorintelligence

Balancing FTO search budgets and risk to extract fullvalue from thc search

what are the FTO risks?how can search budgets be managed and allocatedacross varying classical drugs or bio molecules?

Overcoming the challenges of obtaining, reliable search datainformation sources and using search databascswhat arc the search limitations?

- safeguarding confidential informationKnowing whist happens if FTO assess

10:15 How to Enforce or Defend a Patent Claimin New Markets

Dr. Penny GilbertPartner, Powell & Gilbert (UK)

Annelise HolmeManaging Partner, Holme Patent AIS (Denmark)

Avoiding the risks of getting your FTO wrongHow do the approaches in different jurisdictions affectyour infringernenc and validity analysis?

determining the possibility of amendments:EPO vs. USPTO

assessing utility modelsDetermining the timing of risk

when and where to enforce daims- how to best defend your patentExamining current daims being granted

how do the outcomes impact on existing patents?what is the impact of oppositions?assessing the risk of divisional applications

11:00 Morning Refreshments

11:20 EPO Perspective on Current FTO Challenges

Bertrand GellieDirector, European Patent Office

The new EPO rules on divisional applicationswhat is the impact of the new tales on FTO?what has been the effect on analysing Europeanapplications?

- strategies for overcoming delaysHow is the EPO dealing with oral proceedings?Overcoming validity when you have a pending application- how the EPO is making processes more efficient and

user-friendly

12:00 Challenging Validity to Overcome Blocking Patents

Erik ScheuermannPartner, Witte, Weller & Partner (Germany)

Kristina CornishPartner, Kilburn and Strode LLP (UK)

Determining the chokepoints for your productanalysing the patent landscape: drugs, intermediaries,processes

Assessing and monitoring the gram procedure in variousjurisdictions: the available toolsDetermining the likelihood of being granted a validpatent for the intended market and useBalancing risk versus reward and the price of certainty

litigate/challenge or negotiate?enforcement costs and timelinesdamages and other consequences

The right Court at the right time...where now?Highlighting the EPO and NPO approaches to validity

update on case lawMaking PAIR and EPOLINE work for you

12:45 Lunch

14:00 Repositioning Your FTO Strategy to Capitaliseon the Benefits of SPCs

Tony RollinsIP Counsel, Merck & Co. (US)

Emil PotDirector, Legal & IP Actogenix (Belgium)

Gertjan KiupersPartner, De Brauw Blackstone Westbroa(The Netherlands)

Interpreting the SPC reptationswhat is the level of protection?how does your marketing authorisation applicationoverlap with your patent daim?

To register call +44 (0) 20 7878 6888 or register offline at www.C5-Online.comIFTO

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assessing the likelihood of being granted a SPCMaximising your SPC protection

what is the impact of paediatric extension on the lifeand scope of a valid SPC?

Comparing and contrasting SPC regulations for biosimilars and other compounds- the process to obtain SPCs- the extent of clinical trials- rite data exclusivity provisionsAnalysing the d i fïerent approaches by the EPO, NPOsand USPTO

Medeva y CGPYeda and Aventis CGPGeorgetown UniversityStallergenes y 0C1Vreviewing cases of zero and negative term SPCs

15:00 Utilising Paediatric Exclusivity to Maximisethe Value of Your Portfolio

Eric RuhlmannPatent Attorney, Actelion (Switzerland)

Interpreting the EC regulations to gain accessto paediatric exclusivity protection in Europe- what are the rewards?- what are rhe requirernents - Paediatric Investigation

Plan (P1P), SPCs, timelines?- strategic considerations for orphan meciicinal productsEuropean case law update

Cozaar (losartan)Jan uvia (sitagliptin phosphate monohydrate)

Obtaining paediatric exclusivity in the USwhat are the rewards?what arc the requirements - wrinen request fromthe FDA, timelines?

US case law update- In re Omeprazole Patent Litigation

the Norvizsc case - Pfizer u. Apotex and related decisions

15:45 Refreshment Break

16:10 Highlighting and Contrasting the Regulatory DataProtection Application Processes in Europe

Moderated hy:Alastair McCullochPartner, Jones Day (UK)

Country- by-Country Analysis:Matthias GoerichSenior Regulatory Affairs ManagerMundiPharma (Germany)

Maarren MeulenbeltPartner, Howrey LLP (Belgium)

Paule Drouault-GardratAttorney at Law, PDG Avocats (France)

Cornparing the approaches w RDP across EuropeUK

- GermanyBelgium

- FranceBenefiting from SPC protection and data exclusivityprotection- determining which right is more beneficial

A review of key case law on data exclusivityGenerics u Synaptech

Synthon Merz

17:30 Chairman's Closing Remarks and End of Day One

DAY IWO: 19 MAY 2011

9:00 Chair's Welcome

Anita VarmaPartner, Ropes & Gray LLP (US)

Lisa DixonSenior Counsel, Vertex Pharmaceuticals (UK)

9:10 The Impact of US Developments on EuropeanFTO Analysis

Anita VarmaPartner, Ropes & Gray LLP (US)

Exploring developments in ownership of IP- Stanford y RocheAnalysing patentable subject matter

In re 13i lski

- Prometheus y MayaLabCorp v Metabolite

- Myri adReviewing the written description rules- Ariad v Eli LillyCase law update on obviousness

the signifi cance of KSR u Tele ex- In re KubinFTO considerations in view of the follow-on-hiologicslegislation

9:55 Obtaining Market Authorisation to Diversify YourPatent Portfoiio

Lisa DixonSenior Counsel, Vertex Pharmaceuticals (UK)

David KingDirector, Regulatory Pol icy & Intelligence,Novo Nordisk A/S (Den mark)

Interpreting the EMA guidelines on market authorisationOvercoming the complexities in gaining marketauthorisation

what arc the data requirements for clinical tests?when can a generic present an application?how much protection does market authorisationprovide?

Bio similars vs. traditional chemical compoundshow do the processes differ in gaining access tothe market?how does the level of protection differ?

Implementing strategies to make processes on oldproducts more efficient- using products 2S line extension tools for exisring prOdnerMonitoring variations for authorisation in various market:- what arc the processes to vary authorisations?Exanlining the US approach and the significancefor market authorisation in Europe

10:45 Morning Refreshments

FaxIrder torm to +44 (0) 20 7878 6885 or register online at www.C5-0nline.com/FTO

POST-CONFERENCE WORKSHOP19 May, 2010 I 14:00 - 17:00

Reading and Analysing Claims in Patents and PatentApplications: EU and US juriscliction-specific issues

Workshop Moderators:Dr. Joachim WachenfeldPartner, Vossius & Partner (Germany) Partner,

Dechert LLP (US)Isabelle RometPatent Attorney, Véron & Associés (France)

EU-specific issues

Scope of Bolar exemption in major European jurisdictionsExistence and scope of other infringement exemptionsBases for, and likelihood of, injunction in major EuropeanjurisdictionsPrior user rightsCompulsory license regimesClaim construction differences: UK, DE. other major EUjurisdictionsNon-literal infringement under EU lawDamages calculations in major European jurisdictions

US-specific issues

Validity"Family matters" understanding prior art issues that are "internai"to the patent owner's own portfolio: 102(e), (f), (g) and 103(c)Understanding and applying US secret prior art doctrinesoutside the patent owner's own portfolio - derivation fromor prior invention by "another'': 102(f), 102(g)Obviousness-type double patenting

Patent Scope

Infringement under the Doctrine of EquivalentsEffects of re-examination and reissue on patent owner remediesfor infringementEnforceable scope of a patent extended under theHatch-Waxman Act

Afternoon refreshment break to be included

Dr. Daniel Becker

Infringement Risk Assessment

Understanding the scope of 271(e)(1) Hatch-Waxman exemptionUnderstanding the scope of the common law research exemptionThe statutory rime limit on damages (286)Wilful infringement and treble damagesLikelihood of injunction

Infringement Risk Mitigation StrategiesEx parte and inter partes re-examination in the USPTOAcquiring un-named inventor rightsEstahl ishing declaratory judgment jurisdictionThe arcane and the esoteric: US patent vs. patent interfcrencein District CourtPrior user rights

To register call +44(0) 20 7878 6888 or register online at www.C5-Online.com/FTO

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,111e. e' -..um link JIMr-

It was excellent. It was practical, objective and provided many clarifications for those who draft FTO opinions.I will certainly recommend it to my colleagues.

Ana Carneiro, Industrial Property Agent, Dannemann Siemsen (Freedom ta Operate, May 2010)

Very informative and updated topics that are useful to our IP law practice. 1 would recommend it.

Rana Gosain, Partner, Daniel Advogados (Freedom to Operate, May 2010) it

1105 Insight into the Emerging Markets:A Focus on China and India

Amy FengPartner, Liu, Shen and Associates (China)

Tony ChenPartner, Jones Day (China)

Calab GabrielSenior Partner, K&S Partners (India)

How are the processes and procedures to gain FTOin emerging markets different?Understanding the requirements for obtaining a validpatent- what data records should be maintained?

when is a legal opinion of Counsi: required?nuances involved in pre and post-grant oppositions

Protecting your patents from infringement in emergingmarkets

identifying the key examiners, regulators and Courtsrelevancy of prosecution in patent infringements

How arc the Courts in emerging markets dcaling withfri ngements?China and India case law update

12:05 Understanding the Damages Regime toCategorise and Respond to FTO Risks

Christopher J. HarnettPartner, Ropes & Gray LLP (US)

lain ArmstrongSenior Associate, Harrison Goddard Foote (UK)

Implementing a strategy for managing FTO risksof third party patentsHighlighting the risks of damages and assessingthe likelihood of injunctive relief- commercial relevance of FTO risk

strategies for proportional responseHow are damages assessed and calculated?

factors influencing damagesThe US approach to damages

wilful infringement and punitive damageswritten opinion practice: when and how?

12:50 Chairs Closing Remarksand End of Conference

12:55 Lunch (for Workshop Attendees)

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C5's St" INTERNATIONAL FREEDOM TO OPERATE FORUM

Pharmaceutical and biotech inventions require substantial financial outlay for research anddevelopment activities ami resulting inventions are only as valuable as the patents ultimatelyobtained. Establishing Freedom to Operate by devising and implementing an effectivesearch strategy and evaluation method is vital to commercialising pharmaceutical andbiorech inventions to the exclusion of competitors. The FTO process is essential to identifymiler patents and explore opportunities to purchase or licence potentially infringing patents,thereby reducing the risk of costly infringement litigation.

Only by adopting a practical and sound approach to the processes of searching, obtaining,extending and protecting patents and understanding the latest regulatory developments andindustry trends can you develop and protect a strong patent portfolio whilst minimising riskand reducing costs.

Get the information you need at C5's 8' International Freedom to Operate Forum. Bringingyou an unparalleled faculty, this conference provide you with the best practices you needto conduct a successful and cost-effective FTO analysis. You will benefit from a practicalapproach to analysing and interpreting FTO searches and patent daims, understanding andapplying the regulatory guidelines and gaining insight into the key developments across theUK, US and European jurisdictions.

You requested in 2010's conference feedback and we have delivered:A wider European perspective: high-level speakers from the UK, Germany, Switzerland,Italy, France, Belgium, The Netherlands and DenmarkUpdates on the emerging markets, including speakers from China and IndiaA greater focus on the practical methods and processes of FTO searching and analysis tools

Conference Workbooks: a printed pack of session materials allowing you to rake notesat the event and use back at the office.

PLUS! Maximise your learning with the Post-Conference Workshop on:Reading and Analysing Claims in Patents and Patent Applications: EU and USJurisdiction-specific Issues

Gain both practical and strategic insight into a wide range of European and US-specific FTO issues that will assist you to read and analyse patent daims andovercome the ever-present barriers of interpretation within these key jurisdictions.In particular, you will examine the various aspects of validity, patent scope,infringement risk assessment and infringement risk mitigation strategies, allowingyou to combat the issues of prior art, reduce the risk of damages and expand your patentportfolio to exploit market opportunities in new jurisdictions.

Reserve your place at this invaluable conference today! Register now by calling+44 (0) 20 7878 6888 or registering online at www.C5-Online.com/FTO

-gwWHO SHOULD ATTEND?

From Phanna, Biotech and Chemical Companies:

In-House Counsel and Legal Directors

Heads of IP, IF Counsel and Managers

Heads of Patents, Patent Counsel,Patent Directors and Managers

Patent Specialists/Experts

ASSOCIATE SPONSOR

Global law firm RopesGray, with 1,000 attorneysin nine offices on ducecontinents, is the recipientache 2010 Chambers USA"Award for Excellence" asthe preeminent intellectualproperty practice in the US.

From patent and trademark protection to "betthe company» litigation, we work collaborativelywith our clients to create the strategies that leadto their success.

RIPES

&GU(

I OMM

Private Practice and ln-house Lawyersand Patent attorneys specialising in:

1.Life Sciences/Pharma

IP and Patents

GLOBAL SPONSORSHIP OPPORTUNITIES

C5, along with mir affiliate organisations in New York, AmericanConference Institute (ACI) and in Toronto, The CanadianInstitute (Cl), works closely with sponsors to create the perfectbusiness development solution catered exclusively ro the needs ofany practice group, business line or corporation. With over 500conferences held in Europe. Russia and the CIS, China, India, theUS and Canada, C5, ACI and Cl provide a diverse portfolio offirst-class events tailored to the senior level executive.

For more information about this program or our global portfolio,please contact: Jo Menzer on +44 (0)20 7878 6978 or emailj.menier@C5-Onhine.com

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CONFERENCE CHAIRS

Allen NorrisHead of Group II'. UCB

Anita VarmaPartner, Ropes & Gray LLP

Lisa DixonSenior Counsel, Vertex Pharmaceuticals

FACULTY

Alastair McCullochPartner, Jones Day

Amy FengPartner, Liu, Shen & Associates

Annelise HolmeManaging Partner - Patents,Holme Patent A/S

Bertrand GellieDirector, The European Patent Office

Calab GabrielSenior Partner, K & S Partners

Christopher J. HarnettFariner, Ropes & Gray LLP

Dr. Daniel BeckerPartner, Dechert LLP

David KingDirector, Regulatory Policy & Intelligence,Novo Nordisk A/S

Eric RuhlmannDirector, Senior Patent Counsel, Actelion

Erik ScheuermannPartner, Witte, Weller & Partner

Emil PotDirector, Legal & IP, Actogenix

Emma KoncewiczInformation Officer, MedicalResearch Council Technology

Gertjan KiupersPartner, De Brauw Blackstone Westbroek

lain ArmstrongSenior Associate,Harrison Goddard Foote

Isabelle RometPatent Attorney, Véron & Associés

Dr. Joachim WachenfeldPartner, Vossius 8c Partner

Kristina CornishFariner, Kilburn and Strode LLP

Maarten MeulenbeltPartner, Howrey LLP

Marco NievoIP and Scientific Information,Siena Biotech

Matthias GoerichSenior Regulatory Affairs Manager,Mundipharma

Paule Drouault-GardratAttorney at Law, PDG Avocats

Dr. Penny GilbertPartner, Powell Gilbert

Sarah Boxai'IF Manager, Boxall IPM

Tony ChenPartner, Jones Day

Tony RollinsW Counsel, Merck & Co.

8e" InternationalForum on Freedom to Operate

Practical Approaches to Obtaining and Maintaining FM andInterpreting the Latest Legal and Regulatory Developments

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ADMINISTRATIVE DETAILS

Date: 18 & 19 May 2011

Time: 8:30 17:30

Venue: Sofitel Munich Bayerpost

Address: Bayerstrasse 12, 80335 Munich, GERMANY

Telephone: +49 89 599480

An allocation of bedrooms is being held for delegates at a negotiated rateuntil 15 April. To book your accommodation please call Venue Search ontel: +44 (0) 20 8541 5656 or e-mail beds@venuesearch.co.uk. Please note,lower rates may be available when booking via the internet or direct with the hotel,but different cancellation policies will apply.

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If you are not able to attend, you can purchase a CD of the presentations providedto delegates on the day of the event. Please send us this completed bookingform together with payment of 350 per copy requested. For further informationplease call +44 (0) 207 878 6888 or email enquiries@C5-Online.com.

CONTINUING EDUCATION

9.75 hours (conference only) plus 3 hours per master class towards ContinuingProfessional Developments hours (Solicitors Regulation Authority). Please contactC5 for further information on claiming your CPD points.

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