Pharma & Biotech Patent Litigation in Europe

• Analyzing the guiding principles set by the Enlarged Board for using post-published evidence in inventive step assessment in the G2/21 decision and subsequent written decision of T0116/18 (the referring case which led to the G2/21 decision)
• Differentiating between the EPO approach and that used by the UPC
• Reconciling the EPO’s application with national courts and navigating inconsistent applications
  • E.g., Dutch court of appeal issued two recent decisions on plausibility, but these are not applied at the EPO
• Detailing the impact of these decisions on determining inventive step and devising strategies for effectively incorporating post-published evidence in light of national, UPC and EPO decisions

• Analyzing the developing caselaw for preliminary injunctions at the UPC
  • Establishing “sufficient certainty” that the patent in suit is valid and infringed
  • Interpreting the standard of “urgency” throughout the Local Divisions
    • E.g., “imminent infringement” (in the biosimilar preliminary injunction case between Novartis and Celltrion)
  • Identifying the prerequisites for re-opening a UPC preliminary injunction case
    • E.g., in the diagnostic device case between NanoString and 10x Genomics

The EPO Enlarged Board of Appeal has heard oral arguments on a critical question: whether or not, and to what extent, the claims of a European patent can be interpreted using the description and figures. Settling the disharmony of EPO case law, and harmonizing the EPO and UPC’s approach, will provide important guidance on how to interpret the validity of the patent and the scope of protection provided by the patent. Topics of discussion include:

• Identifying the key cases that led to the divergence in EPO case law with reference to Articles 69 and 84 EPC
  • E.g., the approach used in T 0169/20, T 0223/5, T 1294/20 versus the approach used in T 556/02, T 1473/19, and the ongoing proceedings in T 439/22 (where the Board referred the claim interpretation questions to the Enlarged Board of Appeal)
• Identifying the UPC’s approach to claim interpretation at first instance and at the Court of Appeal
  • E.g., the first instance infringement action filed by 10x Genomics against NanoString; NanoString’s subsequent appeal (CoA decision UPC_CoA_335/2023); and NanoString’s parallel EPO opposition proceedings
• Analyzing the submissions of the amicus curiae briefs and the letter from the president of the EPO for the referral
• Summarizing the oral arguments in the referral (scheduled to be heard March 2025)
• Forecasting the Enlarged Board’s decision and adjusting patentability strategies accordingly

This session addresses the continually evolving landscape of antibody patenting in Europe and the U.S., incorporating crucial case law developments from 2024 into effective prosecution strategies for 2025. 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:

• Adopting effective strategies for claiming antibodies, considering different patent office interpretations and how to draft claims that secure protection across jurisdictions
• Examining how recent EPO decisions, like T 0499/18, and the UPC Central Division’s revocation of Amgen’s patent, influence the acceptability of claims where a combination of antigen plus function is used to define an antibody
• Contrasting the U.S. Supreme Court’s decision, which deemed claims of two Amgen patents invalid due to insufficient enablement for a genus of antibodies, with UPC caselaw
• Understanding the nuances of epitope-based claims, functional antibody claims, combination therapies, companion diagnostics

• Deciphering which substantive law applies at the UPC
  • E.g., what are the tendencies of the UPC’s Local Divisions in applying EPO and national law?
• Distilling the factors for selecting the Local Division versus other venue
• Analyzing the role and use of experts in infringement and invalidity proceedings at the UPC
• 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 and navigating parallel proceedings
• Assessing if the UPC is a pharma-friendly venue through an analysis of the first decisions
• Contrasting the UPC with the U.S., the UK, the Netherlands and Germany

• 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 and China, highlighting their unique patent environment and implications for global patent strategies
• Identifying the key considerations for enforcing patents in non-UPC jurisdictions
• Developing defense strategies and tactics for patent litigation in these jurisdictions
• Examining case studies and rulings from key non-UPC jurisdictions such as the UK to draw lessons and strategies for effective patent rights management

In January 2024, the EC published a report providing an overview of the enforcement of EU antitrust and merger rules between 2018 and 2022. Then in October 2024, the EC fined Teva 462.6 million euros for allegedly abusing its dominant position to delay competition to its blockbuster multiple sclerosis pharmaceutical, Copaxone. The ruling, which Teva is appealing, and the EC’s enforcement report, provide valuable insights into the enforcement cadence of Europe’s antitrust authorities and raises important questions as to the boundary between legitimate and illegal means of competition in the pharmaceutical sector.

• Reviewing the core principles and past cases that have interpreted “abuse of dominant position” under Article 102 of the Treaty on the Functioning of European Union and “misuse” of the patent system
  • E.g., AstraZeneca and Almirall/Boehringer
  • E.g., the January 2024 report published by the EC
• Analysing the facts of the Teva case and identifying the two practices the EC considered as delaying competition
  • Unpacking the EC’s finding that Teva “artificially” extended its patent protection for Copaxone through playing “the divisionals game”
  • Dissecting the EC’s finding that Teva engaged in exclusionary disparagement of a competing glatiramer acetate
• Creating a roadmap for the future of divisional applications that incorporates this unprecedented enforcement cadence