C5's 13th Annual Forum on Pharma & Biotech Patent Litigation in Europe

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February 23–25, 2021 (Central European Time) | Virtual Conference

C5’s 13th Annual Forum on

PHARMA&BIOTECH PATENT LITIGATION IN EUROPE 2021 Co-Chairs: Dominic Adair Partner Bristows LLP Bert Oosting Partner Hogan Lovells

Learn and Connect with Key In-House Stakeholders from: » » » » » » » » »

Regeneron Pharmaceuticals Chiesi Farmaceutici S.p.A. Ichnos Sciences Merck GSK Teva Pharmaceuticals Insud Pharma Sandoz International GmbH (DEU) Fresenius Kabi Deustschland Gmb

The only event where the “Who’s Who” of the European Life Sciences Patent Bar gather annually to shape patent litigation policies and procedures throughout Europe.

EARN CPD CREDITS

Take Stock of Crucial Takeaways from Critical Developments, including: y Gauging the Impact of COVID-19 Across the Global IP Market

y BREXIT and Supplementary Protection Certificates

y Understanding the Expanding Reformation to Patent Infringement

y Tracking Changes in Competition Law

y Analyzing the Impact of DOE Decisions on Global Litigation Strategies

y Virtual Opposition Proceedings

Receive Association Insights from: y Association for Accessible Medicines (AAM) y Biotechnology Innovation Organization (BIO) y European Federation of Pharmaceutical Industries and Associations (EFPIA) SUPPORTING SPONSORS:

C5-Online.com/PPLitigation • +44 20 4532 2313

y Pharmaceutical Research and Manufacturers of America (PhRMA) y Medicines for Europe

ASSOCIATE SPONSORS:

Part of C5 Group’s LIFE SCIENCES GLOBAL SERIES

DISTINGUISHED FACULTY

Aliki Nichogiannopoulou Director European Patent Office

2021 CO-CHAIRS: Dominic Adair Partner Bristows LLP

Heli Pihlajamaa Director European Patent Office

Bert Oosting Partner Hogan Lovells ASSOCIATION INSIGHTS FROM: Andrea Pucci Senior Legal & Compliance Advisor Medicines for Europe Karin Hessler Vice President and Deputy General Counsel Association for Accessible Medicines (AAM) David E. Korn Vice President, Intellectual Property and Law Pharmaceutical Research and Manufacturers of America (PhRMA) Hans Sauer, Ph.D., J.D. Deputy General Counsel, Vice President for Intellectual Property Biotechnology Innovation Organization (BIO) Monika Dorda SVP & General Counsel, GSK Global Pharmaceuticals Chair Competition Working Group/ EFPIA James Horgan Head of European Patents Intellectual Property Department, Merck Sharp & Dohme Corp.

Member of IP Working Group EFPIA HEAR FROM GOVERNMENT: Rainer Becker Head of Unit, DG Competition European Commission Hon. Jacqueline Wright Bonilla Deputy Chief, Administrative Patent Judge USPTO Patent Trial and Appeal Board

2 | #PatentLitigation

André Pohlmann Member of the 5th Board of Appeal European Union Intellectual Property Office

Gordon Humphreys Chairperson of the 2nd Board of Appeal European Union Intellectual Property Office Blaz Visnar Administrator European Commission INDUSTRY ACUMEN FROM: Dr. Dean Thomas Vice President – Global Head of IP and Associate General Counsel Ichnos Sciences Guido Pontremoli, Ph.D. Global IP Head Corp. Intellectual Property-Patents Chiesi Farmaceutici S.p.A. Willem F.C. de Weerd JD, PhD Director, Corporate Patent Counsel Patents Healthcare Merck Laura Reynolds Associate General Counsel European IP and Regulatory Litigation Teva Pharmaceuticals Beatriz Diaz de Escauriaza Head of IP Legal Insud Pharma Sara Burghart Lead IP Litigation Counsel Global Litigation & Launch – Global IP Sandoz International GmbH (DEU) Shohta Ueno, PhD Director, Dispute Resolution Regeneron Pharmaceuticals Dr. Corinna Sundermann Senior Vice President Intellectual Property Management Fresenius Kabi Deutschland GmbH

ESTEEMED FACULTY: Jennifer Antcliff Partner Carpmeals & Ransford Thorsten Bausch Partner Hoffman Eitle Koen Bijvank Partner Brinkhof Advocaten Brian D. Coggio Of Counsel Fish & Richardson Jules Fabre Legal Director Pinsent Masons Dr Penny Gilbert Partner Powell Gilbert LLP Professor Dr. Maximilian Haedicke, LL.M. Professor of Intellectual Property Law Freiburg University (Former Judge at Higher Regional Court of Duesseldorf) Nicole Jadeja Partner Pinsent Masons

Daan de Lange Partner Brinkhof Advocaten Roberto Ribeiro Partner Daniel Advogados Jonathan E. Singer Principal Fish & Richardson Benjamin May Partner ARAMIS Société d’Avocats Marie Manley Partner Sidley Austin LLP Dr. Jochen Herr LL.M. Partner Baker McKenzie Dr. Beatriz San Martin Partner Arnold & Porter Erin M. Sommer, Ph.D. Partner Finnegan, Henderson, Farabow, Garrett & Dunner, LLP Tom Leonard Partner Kilburn & Strode LLP

Reimagining the Way We Deliver Conferences Our virtual conferences are the same conferences you have come to expect in person but transformed to a virtual format. The new virtual conference delivers the same access to a community of industry leaders we have spent decades building and nurturing. We invite you to be part of this community.

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Ensure you have joined our LinkedIn group, Life Science & Pharma Experts: Networking Group, to get access to informative discussions and timely updates about the Life Sciences sector.

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With a historic 2020 behind us, the European Life Sciences Patent Bar will convene in February 2021 to assess pharmaceutical patent trends in Europe, network, and provide a holistic view of the path forward.

F

or years, global pharmaceutical and biotechnology patent law has been on a course akin to a rapidly changing battleground — and 2020 was no exception. The global pandemic ushered in extraordinary roadblocks for the global pharmaceutical and biotechnology industries which only amplified existing skirmishes for control of increasingly competitive intellectual property rights.

Welcome from the Co-Chairs

Now, more than ever, there is a real need to understand what new directions the courts are taking in Europe.

Based on this judicial trajectory, you must understand how to organize for success when protecting against patent infringement or authorizing the distribution of products. Recognize the market forces and identify available patent protections before its too late.

Mastering the ability to secure and capitalize on the investment in patent rights and IP protections will mean a greater economic return for your clients, your products as well as your IP portfolio.

Play VIEW VIDEO

With all this in mind, we have created this conference toward maximizing strategy sharing and bringing together the world’s leading life sciences patent litigators.

You asked, we listened. We have re-imagined conference with a goal to keeping everyone safe — and reaching even more IP professionals worldwide. Our new virtual format offers new possibilities — expect an experience full of new opportunities to connect, benchmark, and expand your global network.

Dominic Adair Partner Bristows LLP

Our virtual event makes distance irrelevant. Attend and come away with the knowledge and skills you need to address post-filing patent litigation challenges and optimise your patent litigation strategies to continuously deliver efficient patent protection in this extraordinarily competitive marketplace. Registration is now open.

Advantages of a Virtual Conference:

Immerse yourself in live presentations, panel discussions and amplified networking opportunities Engage in meaningful dialogue with attendees and speakers in an interactive format

C5-Online.com/PPLitigation • +44 20 4532 2313

Meet 1-on-1 with other attendees and exchange contact information for lasting connections and true engagement Expand your network globally

Bert Oosting Partner Hogan Lovells

PIGGY-BANK

Eliminate the costs and stress of travel

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Reduce waste and carbon footprint through this environmentally friendly platform

Part of C5 Group’s LIFE SCIENCES GLOBAL SERIES

DAY ONE | February 23, 2021

1:30

COVID-19, INGENUITY, INNOVATION AND OVERCOMING CHALLENGES 12:15

Opening Remarks from the Co-Chairs Microphone Dominic Adair, Partner, Bristows LLP

Gauging the Impact of COVID-19 Across the Global IP Market: Lessons Learned from the Novel Coronavirus Microphone Karin Hessler, Assistant General Counsel, Association for Accessible Medicines (AAM)

James Horgan, Head of European Patents, Intellectual Property Department, Merck Sharp & Dohme Co, Member of IP Working Group EFPIA

André Pohlmann, Member of the 5th Board of Appeal, European Union Intellectual Property Office

Aliki Nichogiannopoulou, Director, European Patent Office

The novel coronavirus has instigated arguably the most important patent story of the year. The virus has introduced novel challenges for the pharmaceutical and biotech patent communities. This opening session will analyze the challenges pharmaceutical companies are currently facing as they look toward the next phases of the coronavirus response and recovery.

• Anticipating the potential impact of COVID-19 on IP legal matters, including patent protection for new uses and diagnostics » How will IP protection work? » Can the distribution of a vaccine await licensing and agreement on pricing?

• What is the impact to IP licensing and enforcement? » Compulsory licenses in Europe • Assessing COVID-19 related antibody litigation » Two suits against Regeneron and one v. Pfizer » Assertion of IP rights • Developing strategies for evolving to succeed in a post-COVID marketplace

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• Evaluating compulsory licenses and public interest in Germany • Is public interest in ensuring continued availability sufficient justification to deviate from default position of simply ordering a preliminary or final injunction?

4:00

Dr. Dean Thomas, Vice President – Global Head of IP and Associate General Counsel, Ichnos Sciences

Brian D. Coggio, Of Counsel, Fish & Richardson

• Analyzing the Bolar exemption and its application to the EU and the U.S. • Discussing recent decisions concerning stockpiling, medical devices and process patents • Contrasting the research exemption and reconciling countryspecific variations • Preparing for the SPC manufacturing waiver arriving 2022 • Assessing emerging concerns surrounding these exemptions stemming from the potential to manufacture more drugs than is necessary to fulfill regulatory requirements as a means for prepping for commercial entry 2:15

1:1 Networking Break 3:00

Proportionality, Preliminary Injunctions & Damages: The Ability to Deny, Grant or Tailor Injunctive Relief Microphone Beatriz Diaz de Escauriaza, Head of IP Legal, Insud Pharma

Professor Dr. Maximilian Haedicke, LL.M., Professor of Intellectual Property Law, Freiburg University, (Former Judge at Higher Regional Court of Duesseldorf)

Daan de Lange, Partner, Brinkhof Advocaten

Thorsten Bausch, Partner, Hoffman Eitle

• In light of the Boards of Appeal’s decision in Amgen v. Sanofi, how great an influence is potential invalidity when it comes to a preliminary injunction application?

• Assessing when may preliminary injunctions be denied, regardless if a patent is valid or infringed upon • How important is the role of an infringement assessment in preliminary proceedings?

• Analyzing Article 3(2) of the IP Enforcement Directive 2004/48 » Court measures must be effective, dissuasive and proportionate

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AUDIENCE POLLING

Arrow Declarations and Cross-Border Measures for Relief: Evaluating the Expanding Reach of Their Application

Microphone Andrea Pucci, Senior Legal & Compliance Advisor, Medicines for Europe

Bert Oosting, Partner, Hogan Lovells

12:30

AUDIENCE POLLING

The Evolution of Safe Harbours and Patent Exemptions in Europe and The United States: Understanding the Expanding Reformation to Patent Infringement

Microphone Dr. Beatriz San Martin, Partner, Arnold & Porter

Bert Oosting, Partner, Hogan Lovells

Koen Bijvank, Partner, Brinkhof Advocaten

• Understanding the declaratory action and where they are applicable and most effective • Evaluating trends in recent cases: » Where do the limits of the relief lie? » Negative and positive arrow declarations • Examining court findings relative to arrow declaration for biosimilar entrants that a given product lacked novelty and/or was obvious » Anticipating the extent to which English courts will deign to exercise their discretion to grant Arrow relief in more moderate cases » Comparing negative and positive arrow declarations 5:30

Virtual Opposition Proceedings Before the EPO, the Appeal Court of the Hague and in the PTAB Microphone Hon. Jacqueline Wright Bonilla, Deputy Chief, Administrative Patent Judge, USPTO Patent Trial and Appeal Board

Dr. Corinna Sundermann, Senior Vice President Intellectual Property Management, Fresenius Kabi Deutschland GmbH

Jonathan E. Singer, Principal, Fish & Richardson

Heli Pihlajamaa, Director, European Patent Office

• Knowing when to postpone and when to engage with a virtual hearing • Understanding the practical challenges and tips for success • Analyzing real-life lessons from practice • Examining post grant challenges in the EU and UK • Weighing the pros and cons and key features • Determining the interplay with court proceedings and using as levers in global strategy 6:30 | Conference Adjourns to Day Two

DAY TWO | February 24, 2021 THE CURRENT STATE OF INNOVATOR AND GENERIC CONFLICTS 12:10

Remarks and Recap from the Co-Chairs 12:15

Effectively Managing Global Pharmaceutical and Biotech Patent Litigation Microphone Erin M. Sommer, Ph.D., Partner, Finnegan, Henderson, Farabow, Garrett & Dunner, LLP

Benjamin May, Partner, ARAMIS Société d’Avocats

Guido Pontremoli, Ph.D., Global IP Head, Corp.

Intellectual Property-Patents, Chiesi Farmaceutici S.p.A.

Gordon Humphreys, Chairperson of the 2nd Board of Appeal, European Union Intellectual Property Office

• The pemetrexed story: analyzing the global battle over the infringement of pharmaceutical patents and equivalence • Examining life cycle strategies and filing divisionals • Developing best practices for managing and winning global patent litigation disputes • Coordinating strategies and assessing the role of early decisions in key countries • Determining whether anti-trust issues still have a role on the European stage • Leveraging the substantive and procedural nuances between the U.S. and Europe

» When and where to bring infringement suits in various global jurisdictions » How to develop an international strategy 1:15

A Study in Carve Outs Post-GSK v. Teva: Contrasting the Approach in the U.S. and Europe Microphone Willem F.C. de Weerd JD, PhD, Director, Corporate Patent Counsel, Patents Healthcare, Merck

Hans Sauer, Ph.D., J.D., Deputy General Counsel, Vice President for Intellectual Property, Biotechnology Innovation Organization (BIO)

Jennifer Antcliff, Partner, Carpmeals & Ransford

• Analyzing procedural posture of the case • Understanding second medical use patents & carve Out Strategies » Clarifying the patentability of further medical use inventions • Assessing the implications of second use patents for: » Regulatory » Market Access » Legal • Outlining the implications of the Federal Circuit decision striking down labeling carve-outs • Determining whether post-filing evidence is admissible to show insufficient disclosure of further medical use • How do you now balance competing interests in promoting innovation v. permitting generic drugs?

2:15

1:1 Networking Break

Who Should Attend: y In-House Counsel and Executives from Pharmaceutical and Biotech Companies, including: » » » » »

Head of IP Head of Patent Litigation VP-Intellectual Property Scientific Director Head of Legal/Legal Affairs

» Principal Patent Examiner » Head of Global Strategy » Director Innovation, IP and Portfolio Management » R&D Patent Manager

» Associate VP & Director of Technology Licensing & Commercialization

y Patent Counsel/Law Firm Attorneys with Practises in: » Intellectual Property and Patent Law

» Life Sciences » European Patent Law

C5-Online.com/PPLitigation • +44 20 4532 2313

» U.S. Patent Law

3:15

AUDIENCE POLLING

Regeneron v. Kymab and The Lack of Sufficiency: A Game of Cat and Mouse Crescendos Microphone Nicole Jadeja, Partner, Pinsent Masons

Dr Penny Gilbert, Partner, Powell Gilbert LLP

Tom Leonard, Partner, Kilburn & Strode LLP

• Analyzing when can patents be revoked for claim breadth post-Regeneron v. Kymab • Reconciling the distinction between the requirements for a product claim v. a process claim • Detailing the implications of the landmark Supreme Court decision invalidating Regeneron patent claims » When should patents be available for inventions that are not adequately enabled? » When are patents were unduly broad and lack sufficiency?

4:15

Biologics and Biosimilars: Global Patent Litigation Strategies for Success Microphone David E. Korn, Vice President, Intellectual Property and Law, Pharmaceutical Research and Manufacturers of America (PhRMA)

Shohta Ueno, PhD, Director, Dispute Resolution, Regeneron Pharmaceuticals

Roberto Ribeiro, Partner, Daniel Advogados

Monika Dorda, SVP & General Counsel, GSK Global Pharmaceuticals, Chair Competition Working Group/ EFPIA

• Assessing regulatory and legislative developments impacting the biopharmaceutical industry • Understanding the economics of biosimilars » Considerations for market access, sustainable pricing and reimbursement policies » Market uptake of biosimilar products » Biosimilar v. biosimilar litigation in a crowded market • Are biobetters a viable alternative?

• Innovator v. Innovator litigation » Proportionality/appropriateness of injunctive relief » Whether the claims of a patent are too broad » Increasingly bringing innovator companies with competing pipeline candidates into disputes 5:30 | Conference Adjourns to Day Three

Part of C5 Group’s LIFE SCIENCES GLOBAL SERIES

DAY THREE | February 25, 2021 SPOTLIGHT ON PROCEDURE AND REGIONAL SPECIFICS 2:15

12:10

Remarks and Recap from the Co-Chairs 12:15

AUDIENCE POLLING

BREXIT and Supplementary Protection Certificates Microphone Laura Reynolds, Associate General Counsel, European IP and Regulatory Litigation, Teva Pharmaceuticals

Marie Manley, Partner, Sidley Austin LLP

• Assessment of the current state of the Unified Patent Court (UPC) • Analysing the UK’s decision to no longer participate in the UPC » Will Germany follow suit? » Will Italy take the UK’s place in the Central Division?

• BREXIT: How IP is changing on Jan 1, 2021? » Post-BREXIT, what will the procedure be for obtaining Supplementary Protection Certificates (SPCs)? » What should you do and when? » Royalty Pharma and combination products » Santen and Neurim SPCs • The end of the Neurim SPC? » 6 months extension of SPC for former orphan product 1:15

1:1 Networking Break

Doctrine of Equivalents Applied: Analyzing the Effects of Recent Decisions on Litigation Strategies in the UK and Across Europe Microphone Sara Burghart, Lead IP Litigation Counsel, Global Litigation & Launch – Global IP, Sandoz International GmbH (DEU)

Jules Fabre, Legal Director, Pinsent Masons

Dominic Adair, Partner, Bristows LLP

Dr. Jochen Herr LL.M., Partner, Baker McKenzie

GLOBAL SERIES

Across the globe, the extent of protection afforded by a patent is generally defined by the claims “as read”, or, under the Doctrine of Equivalents. Proving infringement under the doctrine is based on legislation and/or jurisprudence. This session will consider the current status of the Doctrine of Equivalents in Europe, highlighting the laws as they currently exist in, Germany, France, the Netherlands and the United Kingdom.

• Regen Lab v. Estar • Marflow v. Cassellie 3:15

Tracking Changes in Competition Law: Enforcement, Litigation, Settlements and Economic Considerations Microphone Rainer Becker, Head of Unit, DG Competition, European Commission

Blaz Visnar, Administrator, European Commission

• Increased scrutiny from competition law authorities » At issue is the scope of permissible conduct 4:30 | Conference Concludes

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LIFE SCIENCES

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The Pharma & Biotech Patent Litigation in Europe event is part of a group of life sciences conferences that cover every facet of legal and business relevance as well as controversy. Join our email list to receive exclusive discounts, offers and programme updates.

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