Pharma & Biotech Patent Litigation in Europe

Networking Breakfast and Registration

Co-Chairs’ Opening Remarks: Pharma & Biotech Patent Litigation Year in Review

Bethan Hopewell
Partner
Powell Gilbert

Rachel Mumby
Partner
Bristows LLP

Ruud van der Velden
Partner
Hogan Lovells

Over the past year, the landscape of pharmaceutical and biotech patent litigation in Europe has undergone notable transformation. The activation of the Unified Patent Court inaugurated a new chapter in European patent litigation. The landscape has also been shaped by key decisions from the European Board of Appeal and legislative reforms in the pharmaceutical sector, introducing fresh challenges and strategies for patent practitioners. In this conference opening assessment, our 2024 co-chairs will delve into these significant developments, offering a comprehensive analysis of the evolving trends and their implications for life science patent law in 2024.

C5's UPC Institute

Refining Life Sciences IP Litigation Strategies After the UPC’s Inaugural Year

Stefania Bergia
Partner
Simmons & Simmons LLP

Christoph de Coster
Partner
Taylor Wessing

Oliver Jan Jüngst
Partner
Bird & Bird

Dr. Ulrich Blumenröder
Partner
Grünecker Patent

• Evaluating and refining litigation strategies to leverage the experiences and precedents set in the first year of the UPC
• Understanding how initial rulings and procedural nuances have shaped the litigation landscape
• Tailoring offensive and defensive strategies in the UPC context, incorporating lessons learned from the court’s inaugural year
• Understanding which arguments and approaches have proven most effective in this new legal environment
• Understanding which arguments and approaches have proven most effective in this new legal environment
• Analyzing the evolving relationship between EPO opposition proceedings and validity challenges within the UPC
• Assessing how decisions in one forum influence strategies and outcomes in the other

C5's UPC Institute

Adapting Approaches for Defending and Enforcing Patent Rights in Non-UPC Jurisdictions

Rachel Fetches
Partner
HGF Limited

Otto Licks
Founding Partner
Licks Attorneys

Josep Montefuso
Partner
Clifford Chance, S.L.P.

• Analyzing the impact of UPC developments on non-member states and how these jurisdictions are responding to the changing European patent landscape
• Exploring the specific challenges and opportunities in Brazil, highlighting its unique patent environment and implications for global patent strategies
• Strategic considerations for enforcing patents in non-UPC jurisdictions, including leveraging local laws and court systems to the patent owner’s advantage
• Defensive tactics for facing patent litigation in these countries, taking into account the differing procedural nuances and legal frameworks
• Examining case studies and rulings from key non-UPC jurisdictions to draw lessons and strategies for effective patent rights management

Morning Coffee Break

C5's UPC Institute

The UPC One Year Later: Judicial Insights on Year One

Honorable András Kupecz
Legally Qualified Judge, Central Division, Munich Section
Unified Patent Court

Honorable Edgar Brinkman
Legally Qualified Judge, Local Division, The Hague
Unified Patent Court

Moderator:

Professor Willem Hoyng
Partner
HOYNG ROKH MONEGIER Chairman, Advisory Committee of the UPC Member, Drafting Committee of the Rules of Proceedings of the UPC

This judicial roundtable offers a unique opportunity to gain insights from the judiciary’s viewpoint on the UPC’s operations and its impacts over the past year. The judges will share their experiences, challenges, and triumphs in navigating this new legal landscape. Attendees will benefit from a firsthand account of how the UPC has influenced patent litigation in Europe, including changes in procedural dynamics, case management, and decision-making trends. This engaging conversation will not only provide a retrospective look at the UPC’s inaugural year, but also offer foresight into future developments and ongoing evolution in European patent law.

Networking Lunch

Navigating the New Landscape: Assessing the Impact of EU Pharmaceutical Legislation Reforms on Pharma and Biotech Litigation

Jonas Löfgren
Partner
Westerberg & Partners

Sergio Napolitano
General Counsel and External Relations Director
Medicines for Europe

Alexander Roussanov
Partner
Arnold & Porter

This session focuses on the transformative impact of the latest EU pharmaceutical legislation reforms on the pharma and biotech industries. Panelists will detail the implications of these changes, following the European Commission’s comprehensive overhaul, marked by the adoption of a new Directive and Regulation. Topics will include:

• Examining how the new Directive and Regulation, replacing existing pharmaceutical legislation (Regulation 726/2004 and Directive 2001/83/EC), influence market access strategies and innovation within the pharmaceutical industry
• Devising strategies for adapting to new requirements under the revised legislation, focusing on authorization, monitoring, labeling, and marketing of medicinal products, as laid out in the new Directive and Regulation proposals
• Assessing the implications of these reforms on clinical trial frameworks and data management, particularly the transition to the new clinical trials framework under Regulation (EU) 536/2014 and the management of health data sources
• Understanding the new legislation’s impact on Advanced Therapy Medicinal Products (ATMPs) and other innovative therapies, including the European Commission’s focus on the development and regulation of these treatments

Deciphering Plausibility: Post-Publication Evidence in Inventive Step and the EPO’s G2/21 Decision

Oliver Kingsbury
Partner
Elkington + Fife LLP

Thomas Wolter
Partner
Mewburn Ellis LLP

This session will outline the nuances of the EPO Enlarged Board of Appeal’s G 2/21 decision, focusing on its implications for plausibility and inventive step in patent law. Discussion points include:

• Outlining the guiding principles set by the Enlarged Board for using post-published evidence in inventive step assessment
• Detailing the impact of the decision on determining inventive step and drafting patent applications
• Implementing a case-by-case application of the guidelines and their influence on different technical fields
• Devising strategies for effectively incorporating post-published evidence in light of the G 2/21 decision

Afternoon Break

C5's SPC Think Tank

Advancing SPC Strategies in the NEW EU SPC Landscape

Jiri Slavik
Director, IP
Adalvo

Brigitte Carion-Taravella
Principal Patent Counsel, Lead Biologics IP EU Global IP Department, Legal, Ethics & business Integrity
Sanofi

• Discussing the Unitary SPC Framework
  • Understanding how the proposed unitary SPC integrate with the unitary patent system
  • Appreciating the expected benefits and challenges of a centralized SPC application procedure
• Impact on Filing Strategies and Implementation
  • How will the new unitary SPC system affect current SPC filing strategies under the Unified Patent Court?
  • What are the key considerations for implementing a unitary SPC, and which institution might be best suited for this role?
• Debating the Coexistence of Unitary and National SPCs
  • How should the industry navigate the coexistence of unitary and national SPCs?
  • What could be the implications of a unified examination and grant procedure for both types of SPCs?
• Addressing Legal Uncertainties and Solutions
  • What potential legal uncertainties could arise from the new SPC reforms?
  • How can these uncertainties be addressed to ensure a smooth transition and effective implementation?
• Exploring Practical Challenges and Solutions
  • What are the practical challenges in implementing the unitary SPC, especially regarding examination, granting, and appeals?
  • How can these challenges be overcome, and what solutions can be proposed for a seamless integration?

C5's SPC Think Tank

Evolving Dynamics of the SPC Manufacturing Waiver: Use, Impact, and Litigation Trends

Sabrina Duschner
VP Patent Litigation Strategy
Fresenius Kabi

Frits Gerritzen
Partner
Allen & Overy

This session will explore the latest developments in the application and impact of the SPC Manufacturing Waiver. Since its implementation, the waiver has shown a significant influence on the pharmaceutical industry, particularly in terms of manufacturing within the EU. Points of discussion will include:

• Analyzing who is utilizing the SPC Manufacturing Waiver, how it’s being used, and if there’s any evidence of misuse
• Addressing the practicality of the waiver, especially the stockpiling exception, and the mixed feedback from industry participants
• Discussing potential areas of emerging litigation arising from the waiver’s use and examining the disputes related to the waiver regulation
• Analyzing how different entities in the pharmaceutical sector are strategically using the SPC Manufacturing Waiver, and what best practices can be advised to clients in light of recent experiences and legal challenges
• Assessing the case for reforming the SPC manufacturing waiver regime during its upcoming 2024 review period

Conference Adjourns for Cocktail Reception

Networking Breakfast

Co-Chairs’ Welcome Back and Recap of Day 1

Strategic IP Management in Pharma & Biotech Litigation: Insights from Chief IP Counsel

Frank Landolt
Chief Counsel, IP and Legal
Confo Therapeutics

Julia Pike
Global IP Head
Sandoz

Shohta Ueno
Senior Director, Assistant General Counsel – Dispute Resolution
Regeneron

Moderator:

Daan de Lange
Partner
Brinkhof

This opening session brings together leading Chief IP Counsel from both innovative and generic companies to share their insights and strategies for navigating the complexities of pharmaceutical and biotech IP in the European context. Points of discussion will cover:

Innovator Perspectives:

• Emphasizing the role of patents in driving innovation within the European pharmaceutical landscape
• Key strategies for building a robust patent portfolio in a changing European IP environment
• Navigating patent listing and protection strategies in line with European regulations
• Anticipating litigation under the new UPC regime, including the strategic timing for patent defense

Generic Perspectives:

• Identifying viable patents for challenge under European laws and the UPC framework
• Criteria for targeting specific patents for opposition or invalidation
• Approaches to assessing patent invalidity and non-infringement in the European context

Considerations for Both Sides:

• Decision-making on when to engage outside counsel versus handling matters in-house in the European context
• Addressing complex legal challenges and anticipating future trends in European pharma IP law

Emerging Trends and Litigation Strategies for the Global Biologic and Biosimilar Landscape

Nikolai Seltoft
Director
Plesner

Marleen van den Horst
Specialist IP & Technology
La Gro Geelkerken Advocaten

James Horgan
Assistant Managing Counsel
Merck Sharp & Dohme (UK) Ltd.

This session focuses on the dynamic global landscape of biosimilars and biologics, highlighting the latest trends, challenges, and strategies in patent litigation. Topics of discussion include:

• Highlighting the most important cases of the year, including Amgen v Sanofi, underscoring the need for jurisdiction-specific strategies in patent litigation across key markets like the US, Europe, Japan, and Australia
  • Understanding the U.S. Supreme Court’s decision
  • Dissecting the initial win for Amgen in Europe
  • Contrasting the decisions by the Japanese IP High Court
  • Reviewing Amgen’s success in Australia
• Outlining the increasing trend of using global litigation to negotiate settlements and how this shapes broader strategic approaches in the biosimilars market
• Examining how the ‘patent dance’ in biosimilar approval pathways influences litigation timing and strategic choices for biosimilar applicants
• Exploring the interplay of IPRs, PGRs, and BPCIA in the US, and their role in the early resolution of patent disputes before market entry of biosimilars

Morning Coffee Break

The Vaccine Patent Wars: Analysing the COVID-19 Litigation and the Implications for Life Sciences IP

Thierry Calame
Partner
Lenz & Staehelin

Kirsty Dolphin
Partner
Venner Shipley

This session will detail the complex and pivotal patent litigations surrounding COVID-19 vaccines, offering life sciences IP lawyers in Europe critical insights into this rapidly evolving landscape. Session leaders will dissect the intersection of patent law, public health policy, and global access, highlighting strategic considerations and broader implications for the life sciences IP community. Topics of discussion will include:

• Analyzing key cases like Moderna vs. Pfizer/BioNTech mRNA vaccine dispute, assessing their legal arguments, impact on the pharma industry, and implications for biotech patent law
• Examining how top pharmaceutical companies protect their COVID-19 vaccine IP and the impact of these strategies on vaccine innovation
• Detailing the interplay between public health policies, emergency use authorizations, and patent rights during the pandemic
• Assessing the impact of voluntary patent pledges, such as AstraZeneca’s non-profit vaccine pledge, on IP management in health crises
• Exploring key takeaways from the COVID-19 vaccine patent disputes to inform future IP management strategies in health emergencies
• Debating the ethical and legal challenges of balancing global vaccine access with the need to protect innovation through patents

EU Competition Law in the Life Sciences: New Developments, Enforcement Trends, and Economic Impacts

Karin Pramberger
Head of IP
Swiss Pharma International AG

Gabriele Venskaityte
Case Handler
European Commission - DG COMP

As competition law continues to evolve, it is vital for life sciences IP practitioners in the pharmaceutical and biotech industries to stay informed about enforcement trends, litigation outcomes, and settlements, as well as the broader economic considerations that shape these laws. Points of discussion will include:

• Analyzing key enforcement actions taken by European competition authorities, focusing on cases involving pharmaceutical and biotech companies
• Exploring the influence of EU policies and regulations on competition law, including recent directives and guidelines specific to the life sciences sector
• Reviewing recent high-profile litigation and settlement cases within the EU, assessing their implications for market dynamics and legal strategies
• Understanding how market dynamics, such as pricing strategies and market consolidation, are influencing competition law enforcement and compliance in the EU
• Offering insights into how life sciences companies can adapt their strategies to comply with the changing EU competition law landscape and effectively advocate for their interests

Networking Luncheon

Advancements in Antibody Patent Litigation: Integrating 2023’s Key Rulings into 2024 Strategies

Ross Cummings
Partner
Gill Jennings & Every LLP

Hazel Ford
Partner
Mathys & Squire

Mark van Gardingen
Partner
Brinkhof

This session addresses the continually evolving landscape of antibody patenting in Europe and the U.S., incorporating crucial case law developments from 2023 into effective prosecution strategies for 2024. Session leaders will dissect recent influential decisions and explore their implications for drafting and litigating antibody patents in different jurisdictions. Topics of discussion will include:

• Analyzing the Supreme Court’s decision, which deemed claims of two Amgen patents invalid due to insufficient enablement for a genus of antibodies
• Examining how recent EPO decisions, like T 0499/18, influence the acceptability of claims where a combination of antigen plus function is used to define an antibody
• Reviewing effective strategies for claiming antibodies, considering different patent office interpretations and how to draft claims that secure protection across jurisdictions
• Understanding the nuances of epitope-based claims and functional antibody claims
• Assessing recent trends and develop best practices for antibody patent applications, ensuring broad and robust protection

Priority Claims in Focus: Adapting to EPO’s New Stance in G 1/22 and G 2/22

Willemijn Gommans
Team Leader, Biotechnology
NLO

Markus Grammel
Partner
Grünecker Patent

Gregor König
Partner
König Szynka Tilmann von Renesse

Derk Visser
Of Counsel
EIP Partnership LLP

This session will help you make sense of the recent landmark decisions by the EPO’s Enlarged Board of Appeal in G 1/22 and G 2/22, which have softened the approach to assessing entitlement to priority in patent applications. Topics of discussion include:

• Discussing the EPO’s established competence to assess whether a party is entitled to claim priority, as affirmed in G 1/22 and G 2/22
• Analyzing the Enlarged Board’s introduction of a “rebuttable presumption” that a priority claim is valid, significantly altering the burden of proof dynamics in priority entitlement challenges
• Exploring how this shift impacts both patent applicants and opponents in opposition proceedings, including strategies for leveraging or countering priority claims
• Examining the decision’s perspective on transfers of priority rights, especially in scenarios involving joint filings of PCT applications by different parties
• Providing insights into how patent practitioners can adjust their approaches to claiming priority in light of these decisions, ensuring more robust and defensible patent applications

Afternoon Break

Global Shifts in Life Sciences IP: Patent Linkage in China and Developments in the U.S.

Robert Cerwinski
Managing Partner
Gemini Law LLP

This session will examine the evolving landscape of patent linkage litigation in China and recent developments in the U.S., providing critical insights for European companies. Points of discussion will include:

China

• Reviewing significant cases like Chugai v. Haihe and Novartis v. Thery, which highlight the practical application of China’s patent linkage system
• Assessing how the courts’ rulings, predominantly favoring generics, shape litigation strategies for both innovators and generics
• Exploring implications for biologic products and how China’s system is expected to evolve

United States

• Analyzing the impact of changes to FDA’s accelerated approval process under FDORA
• Discussing recent shifts in FDA policies regarding clinical trial diversity and their impact on drug development and patent prosecution strategies
• Discussing how recent U.S. legal decisions, particularly concerning written description requirements, influence global patent strategies
• Exploring how these developments impact European companies involved in life sciences patent disputes

Navigating the Future of AI and IP in Europe

Martin Herzog
Managing Partner
Herzog IP

Jochen Spuck
Chief Technology Officer
EconSight

Pr. Dr. Holger Gohlke
Professor for Pharmaceutical and Medicinal Chemistry
Heinrich Heine University Düsseldorf

Discover the future of life sciences in our essential session on the evolving world of IP and its interplay with technological advancements. We’ll cover AI’s impact on pharmaceuticals, future inventions, and the scenarios reshaping IP rights, underscoring their significance on the legal and economic aspects of the industry. Points of discussion will include:

• Examining how artificial intelligence is transforming drug discovery and development
• Discussing the integration of AI in identifying novel molecules and their medical applications, alongside the legal and technical nuances of IP ownership and invention enablement

• Understanding the prediction of patent grant likelihood, the assessment of uniqueness, disruptiveness, and the economic impact on the valuation of entities owning such patents
• Considering the implications for litigation risk and the strategic management of IP portfolios

• Discussing the challenges and opportunities in patent application drafting enhanced by AI, and the evolving criteria for patentability, especially in terms of inventive step and novelty

• Analyzing strategies to secure high-value patents at an early stage and the acceleration of patent processes
• Evaluating the implications for startups and established companies in gaining a competitive edge in the market

Conference Concludes