Pharma & Biotech Patent Litigation in Europe

February 23 – 25, 2021 (Central European Time)

Agenda (Central European Time)

Conference Program
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Day 1 - Tuesday, February 23, 2021

12:00	Opening Remarks from the Co-Chairs
12:30	Gauging the Impact of COVID-19 Across the Global IP Market: Lessons Learned from the Novel Coronavirus
1:30	AUDIENCE POLLING The Evolution of Safe Harbours and Patent Exemptions in Europe and The United States: Understanding the Expanding Reformation to Patent Infringement
2:15	1:1 Networking Break
3:00	Proportionality, Preliminary Injunctions & Damages: The Ability to Deny, Grant or Tailor Injunctive Relief
4:00	AUDIENCE POLLING Arrow Declarations and Cross-Border Measures for Relief: Evaluating the Expanding Reach of Their Application
5:30	Virtual Opposition Proceedings Before the EPO, the Appeal Court of the Hague and in the PTAB
6:30	Conference Adjourns to Day Two

Day 2 - Wednesday, February 24, 2021

12:10	Remarks and Recap from the Co-Chairs
12:15	AUDIENCE POLLING Effectively Managing Global Pharmaceutical and Biotech Patent Litigation
1:15	A Study in Carve Outs Post-GSK v. Teva: Contrasting the Approach in the U.S. and Europe
2:15	1:1 Networking Break
3:15	AUDIENCE POLLING Regeneron v. Kymab and The Lack of Sufficiency: A Game of Cat and Mouse Crescendos
4:15	Biologics and Biosimilars: Global Patent Litigation Strategies for Success
5:30	Conference Adjourns to Day Three

Day 3 - Thursday, February 25, 2021

12:10	Remarks and Recap from the Co-Chairs
12:15	AUDIENCE POLLING BREXIT and Supplementary Protection Certificates
1:15	1:1 Networking Break
2:15	Doctrine of Equivalents Applied: Analyzing the Effects of Recent Decisions on Litigation Strategies in the UK and Across Europe
3:15	Tracking Changes in Competition Law: Enforcement, Litigation, Settlements and Economic Considerations
4:30	Conference Concludes

Day 1 - Tuesday, February 23, 2021

12:00	Opening Remarks from the Co-Chairs Dominic Adair Partner Bristows LLP (U.K) Bert Oosting Partner Hogan Lovells
12:30	Gauging the Impact of COVID-19 Across the Global IP Market: Lessons Learned from the Novel Coronavirus Karin Hessler Vice President and Deputy General Counsel Association for Accessible Medicines (AAM) 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
1:30	AUDIENCE POLLING The Evolution of Safe Harbours and Patent Exemptions in Europe and The United States: Understanding the Expanding Reformation to Patent Infringement Andrea Pucci Senior Legal & Compliance Advisor Medicines for Europe 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 country-specific 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 Beatriz Diaz de Ezcauriaza Head of IP Legal Insud Pharma Professor Dr. Maximilian Haedicke Professor of Intellectual Property Law Freiburg University (DEU) (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 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	AUDIENCE POLLING Arrow Declarations and Cross-Border Measures for Relief: Evaluating the Expanding Reach of Their Application Bert Oosting Partner Hogan Lovells Koen Bijvank Partner Brinkhof Advocaten Dr. Beatriz San Martin Partner Arnold & Porter 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 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 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 2 - Wednesday, February 24, 2021

12:10	Remarks and Recap from the Co-Chairs
12:15	AUDIENCE POLLING Effectively Managing Global Pharmaceutical and Biotech Patent Litigation 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. 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 Willem F.C. de Weerd 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
3:15	AUDIENCE POLLING Regeneron v. Kymab and The Lack of Sufficiency: A Game of Cat and Mouse Crescendos Nicole Jadeja Partner Pinsent Masons Dr Penny Gilbert Partner Powell Gilbert 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 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 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

Day 3 - Thursday, February 25, 2021

12:10	Remarks and Recap from the Co-Chairs
12:15	AUDIENCE POLLING BREXIT and Supplementary Protection Certificates 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
2:15	Doctrine of Equivalents Applied: Analyzing the Effects of Recent Decisions on Litigation Strategies in the UK and Across Europe 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 (U.K) Dr. Jochen Herr LL.M. Partner Baker McKenzie 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 Rainer Becker Head of Unit, DG Competition European Commission Increased scrutiny from competition law authorities At issue is the scope of permissible conduct
4:30	Conference Concludes

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