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