Agenda - Pharma & Biotech

This breakfast session reviews how courts worldwide are approaching patent injunctions post-UPC launch. Hear perspectives on jurisdictional divergences, evolving standards for proportionality, and the practical risks for cross-border enforcement. Gain clear takeaways on how to manage litigation strategy where remedies remain uncertain and fragmented.

As patent enforcement strategies face growing scrutiny, competition law is increasingly influencing how life science companies manage exclusivity and market access. This session will unpack recent court and authority decisions across Europe, Switzerland, and the United States, spotlighting how regulators are drawing the line between legitimate IP enforcement and anti-competitive conduct. From divisional strategy concerns in the Copaxone case to the exoneration of Novartis by COMCO, attendees will gain a nuanced understanding of evolving antitrust standards and how to adapt their own IP strategy accordingly.

• Analyse the implications of the Copaxone divisional strategy case and what it signals about future antitrust enforcement in the context of IP gaming.
• Understand why COMCO cleared the Cosentyx® patent portfolio case and what it reveals about balancing freedom to operate and competition law.
• Explore the intersection of U.S. antitrust enforcement with FDA listing practices delistings, ANDA exclusivity, and the shifting impact of FTC and Federal Circuit decisions.
• Examine how China’s recent implementation of ANDA litigation and patent linkage modeled on the U.S. Hatch-Waxman system - is impacting exclusivity, competition, and antitrust scrutiny in both jurisdictions.

The UPC was met with caution by the life science sector. Nevertheless, new data from its first two years shows a changing reality - pharmaceutical and chemistry-related litigation is not only present, it’s gaining momentum. This session will offer a deep dive into the UPC’s evolving role in high-stakes life science patent disputes, helping you prepare an informed strategy for 2025 and beyond.

• Understand the latest UPC litigation statistics and what they reveal about pharma and chemistry sector adoption.
• Discover why Milan and Munich are emerging as key venues for life science disputes and what it means for your forum selection.
• Learn how English-language dominance is shaping litigation strategy for multinational teams.
• Analyse how early UPC case law is influencing industry confidence and what your business risks by staying on the sidelines.
• Hear how to coordinate UPC proceedings with EPO oppositions to build an integrated and effective litigation approach.

With the UPC now established, its impact on national litigation in key life sciences jurisdictions is becoming clearer. This session examines how the UPC’s decisions intersect with proceedings in the UK, France, Germany, the Netherlands, and the US. Speakers will explore recent cases, including BSH v. Electrolux and Fujifilm v. Kodak, assessing the reach of the UPC, divergence in substantive law, and the evolving balance between national and supranational enforcement.

• Discuss the impact of early UPC rulings on litigation strategies in the UK, France, Germany, and the Netherlands
• Analyse the long-arm reach of the UPC and lessons from cases such as BSH v. Electrolux and Fujifilm v. Kodak
• Compare how national courts and the UPC apply substantive law in overlapping disputes
• Evaluate strategic considerations for coordinating litigation in the UPC versus national and US courts

Supplementary Protection Certificates remain a critical and complex aspect of pharmaceutical patent strategy. This session offers a comprehensive review of recent landmark rulings and evolving practices across Europe, providing life sciences patent holders with key insights to refine their SPC approaches in 2025.

• Explore pivotal cases such as Teva/MSD and Halozyme, and their impact on Articles 3(a), 3(c), and 1(b) concerning combination products and active ingredient interpretation.
• Understand how recent UK decisions, including Merck v Comptroller (2025), reflect divergence from broader European SPC practice, and examine emerging trends in antibody SPCs and unitary SPC legal status.
• Examine the expanded SPC Manufacturing Waiver regime since 2022, including conflicting rulings from Belgium, Germany, and the Netherlands on storage, export, and notification requirements.
• Gain practical guidance on managing waiver-related risks, protecting exclusivity, and navigating cross-jurisdictional challenges in SPC enforcement and litigation.

The EU pharmaceutical package is set to reshape the European life sciences landscape, with reforms covering data exclusivity, compulsory licences, and SPCs. At the same time, high-profile disputes such as Tecfidera have exposed the litigation risks around exclusivity calculations. This session combines a regulatory overview with a litigation focus to help in-house teams anticipate challenges and adapt their exclusivity strategies.

• Assess proposed reforms to data exclusivity periods and their implications for generic market entry and incentives for innovation.
• Analyse the Tecfidera litigation at the CJEU and national level as a case study in exclusivity disputes and portfolio risk management.
• Examine the introduction of compulsory licences in emergency situations and the resulting litigation risks for originators.
• Evaluate the EU’s push for a centralised unitary SPC system and how it may alter enforcement and harmonisation.
• Debate how exclusivity reforms will influence competition law, supply chain security, and environmental requirements.