IP Life Sciences: Under the

Microscope

Drive Rapid Innovation, Seamless Growth And Increased

Value In Your IP In 2016

Supported by:

+44 (0) 207 368 9484 |

info@thelegalexchangenetwork.com

IP Life Sciences Exchange

Supported by:

IP Life Sciences Exchange

+44 (0) 207 368 9484 |

info@thelegalexchangenetwork.com

CONTENTS

KEY THEMES

THE INTERLINK BETWEEN IP LAWS AND BIODIVERSITY LEGISLATION: WHY YOU SHOULD BE PAYING ATTENTION

ALIGNING IP STRATEGY WITH THE REST OF THE BUSINESS IN ORDER TO YIELD RESULTS

PREPARING FOR CHANGE: BREXIT AND THE UPC

ASSESSING PATENT ELIGIBILITY FOR BIOTECH INVENTIONS IN 2016

Supported by:

IP Life Sciences Exchange

+44 (0) 207 368 9484 |

info@thelegalexchangenetwork.com

KEY THEMESBIOTECH

INVENTIONS: We need to find a way to transform

the IP system in these areas into something which is more open, more transparent and makes

innovation more accessible, so that we get the broader society and political support to back

these kind of innovations.

Post Brexit, uncertainty

on SPCS remains the same. As IP counsel we must come together and closely watch

the next steps in order to ascertain whether we need to prepare new strategies.

Without a doubt the UP AND UPC will be worse off without the UK. As one of the

main countries for patent filing and patent litigation in Europe,

most commentators see the inclusion of the UK as

central to the success of the new regime.

The new technologies in

GENOME EDITING will have a substantial impact on IP in

2016 and beyond. Such technologies could become game

changers in pharma, biotech, plant and animal breeding and

many other industries.

I don’t think it’s credible in these emerging areas if firms go out and say,

“I HAVE THE SOLUTION FOR EVERYTHING AND I

WILL SOLVE ALL OF YOUR PROBLEMS.”

That is neither credible nor expected.

IP AWARENESS should not only exist in formal procedures

and processes, but based on a certain IP mindset, which should

be one of the driving factors for research, development and

commercialisation activities.

Supported by:

IP Life Sciences Exchange

+44 (0) 207 368 9484 |

info@thelegalexchangenetwork.com

THE INTERLINK BETWEEN IP LAWS AND BIODIVERSITY LEGISLATION: WHY YOU SHOULD BE PAYING ATTENTION

Q1. Please can you outline the scope and responsibilities of your role as Head of IP at Syngenta?

As Head of IP, I deal with all intellectual property issues for Syngenta, which means patents, plant breeders’ rights, trademarks, trade secrets and so on. My team and I are also addressing broader freedom to operate and licence to operate issues, which touch on regulatory frameworks such as the Nagoya Protocol Convention for Biological Diversity.

Q2. As you’ve already touched upon regulatory frameworks, there has recently been growing interest from politicians and stakeholders to revise EU Biotech Directive 98/44/EC, which excludes certain plant innovations from patentability. In view of the recent expert group report on said directive, what are the implications for IP life science departments?

There are both short-term and long-term implications. I think the short-term implication is legal uncertainty. For instance, how will IP protection for biological innovations be handled in Europe in the future? The long term implication is to understand what the root cause of this challenge is: Why are we losing support for biotech inventions in Europe?

Is there a perception that the public good is being privatised?

Is it how we use IP? Is there a perception that we either use it as a monopoly to exclude, or we use it as a mechanism to enable benefit-sharing?

Particularly in areas such as food, agriculture and health - the patentees, the innovators – are their own worst enemy.

We therefore need to find a way to transform the IP system in these areas into something which is more open, more transparent and makes innovation more accessible, so that we get the broader society and political support to back these kind of innovations.

Q3. Moving on to open licensing, it seems that there is a growing resistance against IP in the area close to elementary human needs: access to food and health. Can the models being developed in Canada and the Netherlands be a part of the solution? What will the challenges be for IP departments?

Yes, these model prototypes can really reshape the patent system which is seen as closed and focusses on exclusivity, to something which is more open, focussing on technology dissemination and benefit-sharing. For instance, the international licensing platform for vegetables in the Netherlands is a very unique prototype in that area. In this licensing platform, patent fees from different companies representing more than 60% of the vegetable industry have made their IP accessible and exchangeable at a low transactional cost. This is because they have recognised that there is a strong advantage- almost a precompetitive advantage.

The long term implication (98/44/EC) is to understand what the root cause of this challenge is: Why are we losing support for biotech inventions in Europe?

How does it work? It’s quite simple. Each party agrees to establish a licensing platform where every party, whether you have patents or not, can come in and request a licence for fair and reasonable conditions. As such, the patentee deliberately decides to surrender control over the pricing and to put it in the hands of an expert committee, so that if you cannot bilaterally agree, the committee can set the price or decide what price is fair.

Ultimately, it’s a prototype. In some areas it may look different, but I think it’s this kind of change in culture and mindset which especially patent departments and IP departments, not only need to embrace, but also lead. But it’s very difficult. It’s very difficult because you cannot do both. You cannot focus your energy on protecting the status quo (defending the patent system, insisting nothing should be changed), and at the same time, trying to drive change.

Dr. Michael Kock, Global Head IP, Syngenta

Michael is Global Head IP – Seeds and Biotechnology with Syngenta International AG in Basel, Switzerland. Prior to this, he was Senior IP Counsel with BASF AG responsible for plant biotechnology and China IP matters. He is a qualified European Patent Attorney and will be speaking at IP Life Sciences Exchange on November 15th 2016.

Supported by:

IP Life Sciences Exchange

+44 (0) 207 368 9484 |

info@thelegalexchangenetwork.com

Very often patent offices are caught in the past, trying to establish and confirm the status quo. As such, it is very difficult for them to look ahead to understand, recognise and accept societal changes and say: “Okay, what does that mean for IP regimes? How do I engage with stakeholders to drive the evolution of the system to make sure we are not losing it, but rather maintaining it?”

Q4. The “patent of life” issue is often linked to the issue of biodiversity legislation and the Nagoya Protocol. How do these two areas fit together? And why should IP departments care?

Well, you could call it “patents through the back door.” In emerging markets, they have succeeded in establishing ownership rights in biodiversity, which are in essence an IP right. However, they have done this to retaliate against companies from developed countries going in and taking biodiversity, developing it, filing patents and then charging a lot of money back to the emerging markets.

Very often patent offices are caught in the past, trying to establish and confirm the status quo

The emerging markets have gone on to create their own quid pro quo within their IP regime. Now the emerging markets are saying that, “If you want to use my biological resources, first you need to ask my permission (so you need to get a licence), and then you need to pay me a fair benefit (royalties).”

Unfortunately it’s an IP regime which is highlighting the limitations and exclusions we normally have in IP regimes to ensure proper balance with public good. For instance, there needs to be limitations on term, minimum thresholds on inventiveness, research exemptions, and all the other elements which normally make a balanced system. So what does it mean for IP departments? I think IP departments need to see this as an IP regime which could drastically affect the freedom to operate of the companies.

Q5. It seems like these challenges are part of an increasing global pattern of IP erosion. If you had a crystal ball, what will be the primary challenges and emerging solutions you would expect to see in the next five to ten years that align with global in-house IP demands?

Yes, we can certainly see change, which for some looks like IP erosion. I think it’s a development which goes hand in hand with the progression of society. If society becomes more open, more interconnected, which it certainly is, then anything which is perceived to be closed and exclusive is almost seen as a foreign object and then it lacks support.

I don’t think we can turn back the clock and make our society less open and surrender its benefits. I think that we just need to accept it as a trend and say, “Okay, how can we still ensure that in an open system where you have less

exclusivity, you can still maintain a fair benefit on bringing innovation to market?”

That will be a big challenge, to make it feel less like compulsory licences and more like access and benefit-sharing.

Q6. Thinking about the ways in which you’ve worked with law firms, how do you think the in-house/ law firm relationship will develop over the next few years, and what do external firms and attorneys need to offer to retain or win your business?

I think external law firms need to become more like sparring partners in developing new solutions for emerging problems. I don’t think it’s credible in these emerging areas if firms go out and say, “I have the solution for everything and I will solve all of your problems.” That is neither credible nor expected.

However, what you really need is to be connected with local lawmakers, local stakeholders in your respective countries and to understand what the legislative intent is. We want to know how we can find compromises. As such, external law firms need to emerge from technical legal experts into advisers, coaches, matchmakers and mediators.

Q7. Finally, what external factors do you think will have the biggest impact on IP protection over the next few years and why?

I think it’s the increasing openness of society and also the increasing impact of “society”. For instance, an increase in direct societal pressures on law making has recently helped NGOs exercise tremendous pressures on politicians, which is shaping many new policies in IP law.

As such, we need to become better at explaining the benefits of innovation to society, which is not always easy. We also need to be able to describe the benefits of IP. We need to be able to get the deviating interests of all stakeholders and markets under one roof regularly to discuss.

Obviously, this will be very, very difficult. However, law making in the future will be much more inclusive, which means we as the innovating industry need to be able to make our business case to a much more diverse societal group than ever before.

I think external law firms need to become more like sparring partners in developing new solutions for emerging problems

Supported by:

IP Life Sciences Exchange

+44 (0) 207 368 9484 |

info@thelegalexchangenetwork.com

PREPARING FOR CHANGE: BREXIT AND THE UPC

With the UK on course to leave the EU, this Briefing Note discusses the impact that this will have on European patents and on the launch of the Unitary Patent (UP) and the Unified Patent Court (UPC).

There is no impact on the grant of European Patents

The European Patent Convention is an international (not European) treaty; therefore BREXIT will have no impact on the grant European patents (EPs) and the validation of EPs in the UK. Patentees will still be able to obtain patent protection for the UK through the European Patent Office (EPO), which is not an EU institution, in exactly the same way as they do today. UK-based European Patent Attorneys will continue to be able to file, prosecute, validate and oppose EPs for clients before the EPO covering all designations as is the current practice.

What will happen with the UPC and UPs?

The future of the UPC is uncertain and its launch will certainly be delayed, probably by some years, by the UK withdrawal from the EU. The UK has not triggered “Article 50” which formally signals its intention to start the 2-year period of negotiation to withdraw from the EU. At present there is no clarity on when this might happen and until the end of that period, the UK remains a member of the EU.

If, after a re-negotiation, the UP system comes into force then because the UK will not be part of the EU a UP will not extend to the UK and the UPC’s jurisdiction will not cover to the UK. However, UK-based European Patent Attorneys will be able to validate the UP designation and represent clients before the UPC Courts. As most patentees consider the UK an integral part of their European patenting strategy

(50% of EPs are only validated in the UK, Germany and France1) applicants will continue to want UK patent protection. As is the case now, to obtain patent protection in the UK from a granted European patent application, patentees will be able to validate separately for the UK.2

The UK’s process of ratification for the UPC had started but it is unlikely that there will be a political will to finish this process. The UPC can only come into effiect when ratified by 13 participating countries which must include the three EU Member States in which the most EPs had effiect in 2012 (the year before the Agreement was signed (Article 89)). Once the UK leaves the EU, the three EU countries required to ratify will be Germany, France and Italy. By June 2016, a total of 10 Member States had ratified the UPC Agreement: Austria, Belgium, Bulgaria Denmark, Finland, France, Luxembourg, Malta, Portugal and Sweden.3 Italy, Lithuania and Germany are moving through the legislative process to ratify the UPC Agreement although it is not clear if the legislation in these countries will now be put on hold.

It is expected that the participating EU Member States will re-locate the London section of the UPC’s Central Division to a country within the EU. The potential contenders for the Court’s new location are Milan and The Hague. However, to do this will require the re-opening of at least Article 7(2) of the UPC Agreement. There has been some concern that amendment to the UPC Agreement would potentially open up renegotiation on other points, which could lead to even further delays or the entire breakdown of the Agreement.

Rachel Fetches, Intellectual Property Litigation Partner, HGF

Rachel has worked with clients across a broad range of sectors including, life sciences, chemicals, food and beverage, aviation, media and telecommunications industries. Rachel has extensive experience of litigating before the Patents Court, as well as in patent and trade mark oppositions before the UKIPO, EPO and OHIM. Rachel also regularly advises in relation to pan-European IP strategy for both patent and trade mark proceedings and will be speaking about the future of the Unitary Patent system and Unified Patent Court on November 15 and 16, at IP Life Sciences Exchange.

Supported by:

IP Life Sciences Exchange

+44 (0) 207 368 9484 |

info@thelegalexchangenetwork.com

What happens to UK patents if the UPC launches?

If and when the UPC does launch, to enforce EP patents in the UK, national proceedings before the UK’s Patents Court will be required as the UPC’s jurisdiction will not cover to the UK. As is currently the case, any revocation action would need to be brought at a national level. However, it will be interesting to see whether the UK Patents Court adapts it procedures to be closer to the UPC system and if there is a move to reduce the overall costs of the UK system in-line with the expected costs of using the UPC.

Will the UP and UPC be attractive without UK’s participation?

Without the UK, which is currently one of the key economies in the region and has high levels of patent filings and litigation, the UPC will be less commercially attractive. If the current “Top 4” fee system is maintained then a UP will be a less financially attractive option. With the UK outside of the UPC patentees will not be able to enforce any injunction granted by a UPC Court in the UK. Lastly, the UPC will also not have the benefit of the direct influence of the highly respected UK Patents Court Judges to shape its jurisprudence.

How will the UK’s exit impact on the opt-out decision?

The introduction of the UPC will impact on all owners of EP patents as, unless opted out, they will be subject to the jurisdiction of the UPC within the participating EU Member States4. With the UK set to exit the EU, UK EPs (granted and pending) will not automatically be subject to the jurisdiction of the UPC as the UK will fall outside the jurisdiction of the UPC. The UK’s position outside the UPC system may make the decision to opt-out more straightforward for some patentees.

Even with the uncertainty over the launch of the UPC, it is important to ensure that your European patents are UPC Ready. If you would like to discuss strategy development or portfolio review, HGF can provide you with assistance and guidance on formulating and implementing your company’s UPC strategy.

Should you have any further questions about the UPC and opt-out please contact our dedicated UPC team on UPCReady@hgf.com or contact your usual attorney to discuss these issues further.

COMMENT: Dr Nicholas Ruiz, Head Of IP,

Q1. What do you think will happen to the Unitary Patent system and Unified Patent Court now that Britain has decided to exit the EU? Is it worth going ahead?

Now that Britain has decided to exit the EU, the Unitary Patent System may still go ahead, due to the need to protect innovation in Europe. However, the Unified Patent Court is now questionable due to the value of the UK market and the experience of the UK courts and Judges that may remain out of the game.

Q2. Would the UPC system still be commercially attractive without Britain?

It may be highly questionable. According to the future new map, we may be faced with 3 parallel litigation systems: Central, UK and Spain (assuming that all other countries ratify).

Q3. If it is worth going ahead and the UPC needs be re-written, what will the impact of even more delays have on the IP sector?

Some adjustments to the agreement may be needed, but it would be worth to avoid as a new ratification process may then be needed. The delay which is expected, around two years, (assuming UK does not ratify, which would be logical) will only give more time for the preparation.

Q4. What is the main impact to SPCs for IP Life Science patents, post Brexit? What should IP counsel do to prepare and protect their patents today, if anything?

Uncertainty on SPCs remains the same, but a new national component appears. As IP counsel we must come together and closely watch the next steps in order to ascertain whether time is extended or whether we need to prepare new strategies.

Supported by:

IP Life Sciences Exchange

+44 (0) 207 368 9484 |

info@thelegalexchangenetwork.com

ALIGNING IP STRATEGY WITH THE REST OF THE BUSINESS IN ORDER TO YIELD RESULTS

Q1. What do you think a strong IP culture looks like in an organisation and why is it important to develop such a culture?

A strong IP culture is key for both IP generation and FTO. IP can create substantial value for a company – even for smaller or medium sized entities; on the other hand FTO is one of the most important risk management factors. IP awareness should not only exist in formal procedures and processes, but based on a certain IP mindset which should be one of the driving factors for research, development and commercialization activities.

Q2. What are the challenges IP leaders face when they seek to change company culture so that IP is at the heart of decisions, and do you have any advice on how to overcome such challenges?

In many companies IP – similar to Legal – is sometimes considered as a bottleneck for research and innovation. IP is being perceived as a function which needs to “approve” activities and has the power to stop innovation by indicating too many risks. Therefore it is of uttermost importance for all IP leaders and staff to identify themselves with projects, find pro-active solutions and establish the IP department as a service provider rather than as a “police” function. Creating IP awareness right from a first project idea, establishing close links and interactions between IP and science throughout all development phases of projects beyond formal processes does raise IP awareness and makes IP a key decision factor for product development and commercialization. Increasing IP awareness does also translate into identifying IP value capture opportunities which in itself does a lot in changing company cultures on the importance of IP.

Q3. Many IP leaders are trying to better align IP with their business – why are IP Heads trying to do this and how can they make this happen in practice?

IP has a crucial and even decisive impact on business cases, commercialization models and marketing strategies for products. Very often IP is largely perceived as being related to research and IP generation, the impact on commercial activities is not always immediately obvious – in particular for industries with long product development timelines. Therefore it is important to align research and business objectives right from the beginning in early project phases. Internal IP committees or IP circles should develop tailor-made IP strategies for products and technologies which are to be translated into IP filing strategies and marketing

campaigns. Such IP committees should therefore consist of a variety of company stakeholders and would at best include research, business, regulatory, finance and IP.

Q4. Recruiting and developing the right talent is key when it comes to driving the right culture and aligning with the business. What type of individuals do you think are needed for the IP department of the future?

Choosing a career in IP is usually a decision which was not foreseen right at the beginning of studies. In most cases, the interest in IP is being developed due to own experiences with inventions at university or within a company. It is therefore difficult to describe a “typical” IP person. However, as an In-house IP colleague one should have an interest to look beyond the mere science and link science and research activities with business objectives and goals. An entrepreneur spirit is very favorable. Since IP is usually a department serving a variety of internal clients among different hierarchies, communication skills are a must – at best combined with a certain service provider/business partner attitude.

Q5. How do you think external advisers / attorneys / solution providers can support IP directors to better align with the business and protect their IP rights globally?

External advisers should make an effort to understand the business objectives of the client. At best an external adviser provides documents and advice in a pragmatic and business-oriented way that can be used immediately by the internal IP staff. Concrete recommendations and answers are key. Nothing is worse than recommendations which do not give a clear answer, but only introduce several options without indicating what would be preferred and why.

Q6. If you had a crystal ball, what do you think will have the biggest impact on the IP sector in 2016?

The new technologies in genome editing will have a substantial impact on IP in 2016 and beyond. Such technologies could become game changers in pharma, biotech, plant and animal breeding and many other industries. It will be quite important to see how the rapidly increasing patent (application) landscape develops and whether dominant patent holders pursue broad or rather narrow licensing strategies.

Claudia Hallebach, Head of RD Legal Affairs and Intellectual Property, KWS SAAT AG

Claudia joined the company in 2008 and has been Legal and IP lead in major M&A, IP license and RD transactions and will be speaking at IP Life Sciences Exchange on November 15th.

Supported by:

IP Life Sciences Exchange

+44 (0) 207 368 9484 |

info@thelegalexchangenetwork.com

The biotech industry on both sides of the Atlantic is facing serious challenges in protecting its inventions. Effective patent protection is one of the key drivers of the research-intensive high-tech biotechnology sector and stands out as one of the global industries with the highest percentage of sales re-invested in research and development.

Without the prospect of a reasonable return on their investments, biotech companies in the sectors of healthcare, agriculture and industry would not be in a position to bear the substantial costs of developing cutting-edge innovations. Against this backdrop, alarm bells on both sides of the Atlantic are ringing.

The EU has specific legislation on the legal protection of biotechnological inventions, known as Directive 98/44/EC (July 6, 1998). In the US, the 2013 Supreme Court “gene patenting” case and the USPTO Interim guidance on patent subject matter have led to increased uncertainty for biotech companies in the area of IP. Against this backdrop, Christoph Rehfuess, Head of IP at Sotio, highlights his experience of the effect of uncertain patentability on the business model of biotech companies:

Q1. Why is effective patent protection, predictability and uniformity so crucial to the research-intensive high-tech biotechnology sector?

First of all, patent protection is crucial as there are high development expenses based on regulatory requirements. The margins in the biotech/pharma field are also exceptionally high; i.e. without protection (basically through patents, to some extent due to data exclusivity, orphan protection) generics would quickly take over market share and lead to price erosion.Due to long development timelines (about 12 years), material changes to patentability may also scrutinize earlier investment decisions and would generate uncertainty in the future. Further, introducing changes to the Directive (98/44/EC) and waiting for court interpretation may take at least five to 10 years.

Q2. Why has the Biotech Directive 98/44/EC been pushed into the political limelight of late? Should biotech patent holders be pleased?

Discussions derived from the agro-biotech field in Europe. Here, patentability of genetically engineered seeds as well as enforcement rights / breeders’ exemptions are the focus of the

discussion. But there certainly is a danger, that developments with respect to the diagnostic field/natural products in the U.S. (Sec. 101 patent eligibility) may get included into this discussion, once the directive is re-discussed.

Q3. In the wake of the Expert Group’s review of Biotech Directive 98/44/EC and their decision not to reopen the Directive, are there any positives to this? Do you think it will be faster and more predictable to review the Directive using non-legislative methods?

The Expert Group’s decision in my view is highly welcome. It is the usual system that legislature provides the framework (here, the Directive) which needs interpretation by courts dependent on individual cases but also through development over time. Re-opening the directive and negotiating it, followed by the interpretation of the courts would take much longer and results would be less predictable compared to the situation we have now, where courts decide cases which become law over time.

Q4. In the US, have you visibly noticed the impact of patent eligibility erosion applied to inventions which remain soundly patent-eligible in other jurisdictions? What is your strategy for coping with this?

The recent decision by the CAFC in the case Ariosa Diagnostics, Inc. v. Sequenom, Inc., 788 F.3d 1371 (Fed. Cir. 2015) shows that important inventions/claims are no longer patentable in the U.S. Applicants will have to test various claim formats to fulfill the new requirements – the outcome of which is more or less unpredictable.

Q5. What are your tips to advise biotech companies on successfully navigating the uncertain patentability waters in the EU and US in 2016?

More than ever try to get multiple layers of protection to protect the various aspects of the technology/product. Try various claim formats especially in the U.S. Do not get tired fighting for strong patent rights and get involved in public discussions.

Nicholas Ruiz will be speaking at IP Life Sciences Exchange on November 15th.

Christoph Rehfuess, Head of IP, Sotio

Dr. Christoph Rehfuess is Head of IP at SOTIO a.s., an international biotechnology company with facilities in Europe, the U.S., China and Russia developing new medical therapies for cancer and autoimmunity diseases. SOTIO is also leading the efforts of PPF Group to build a diverse biotechnology portfolio through collaborations, in-licensing, investments, mergers and acquisitions. Christoph will be speaking at IP Life Sciences Exchange on November 15 and will highlight his experience behind the effect of uncertain patent eligibility on in-house counsel.

PATENT ELIGIBILITY FOR BIOTECH INVENTIONS: STRATEGIC STEPS TO TAKE IN THE WAKE OF THE EXPERT GROUP’S REVIEW OF BIOTECH DIRECTIVE 98/44/EC

Supported by:

IP Life Sciences Exchange

+44 (0) 207 368 9484 |

info@thelegalexchangenetwork.com

FIND OUT MORE ABOUT PATENTABILITY ISSUES, BIODIVERSITY, UNITARY PATENT AND ALIGNMENT OF IP STRATEGY

SPEAKERS AT THE 2016 IP LIFE SCIENCES INCLUDE

IP Life Sciences 2016 will be back on 15th – 16th November 2016 in Munich, Germany to maximize innovation, growth and the value of your pharmaceutical and biotechnology IP through practical strategies.

DOWNLOAD AGENDA JOIN THEM

Dr Michael KockHead of IP

Syngenta AG

Arno HartmannHead of PatentsPharmaceuticals

Merck Group

Susan ChiappinelliVP, Patents Pharma Platforms, Global

Patents, Legal Central FunctionsGSK

Dr. Franziska PreissingerHead Patent Litigation (ex US)

Novartis

Sandeep RathodAssistant General Counsel (VP)

Head Litigation and IP Policy India & Emerging Markets

Mylan Laboratories Limited

Professor Jochen MassGeneral Manager R&D

Sanofi-Aventis

Ravinder ChahilHead of IP

Polpharma

Henrik MathiassenDirector and Head of IP

Zealand Pharma

Nicolas RuizDirector of IP

Esteve

Marjan FrikVP Legal Affairs

Keygene

Christoph RehfuessHead of IP

Sotio

James RobertsonExecutive DirectorHead of Patents

LEO Pharma

Sam GranataJudge

Commercial CourtAntwerp, Belgium

Dr. Sven J.R. BostynChair Of Expert Group

Development And Implications Of Patent Law In The Field Of

Biotechnology AndGenetic Engineering

European Commission

Claudia HallebachHead of R&D,

Legal Affairs & IPKWS

Harriet StrimpelChief IP Officer

New England Biolabs

Diane M. FrenierPartner

Reed Smith LLP

Yan GongPartner

China PatIntellectual Property

Office

Rachel FetchesPartnerHGF

Eswaran IyerAssociate Vice President Sun Pharmaceuticals

Pierre KaryGlobal Patents

Lundbeck