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)

James Horgan
Head of European Patents Intellectual Property Department, Merck Sharp & Dohme Corp.
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

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

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 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.

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

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)

Dr. Jennifer Antcliff
Partner
Carpmaels & Ransford

  • Analyzing procedural posture of the case
  • Understanding second medical use patents and carve-out strategies
  • Outlining the implications of the GSK v Teva litigation for indirect infringement liability
  • Contrasting GSK with the decision of the UK Supreme Court in Warner-Lambert v Actavis
  • Assessing the implications of second use patents for:
    • Regulatory
    • Market Access
    • Legal
  • 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

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

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 Global Pharmaceuticals
GSK

  • 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

Pedro Callol
Founding Partner
CALLOL, COCA & ASOCIADOS, SLP

Blaz Visnar
Administrator
European Commission

  • Increased scrutiny from competition law authorities
    • At issue is the scope of permissible conduct

4:30
Conference Concludes