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:

• European insights on global cases
• Analyzing key global cases such as Amgen v Sanofi, focusing on their implications within the European legal framework and the necessity for jurisdiction-specific strategies
• Assessing the impact of international decisions on EU practices
• Examining how significant rulings, like those from the U.S. Supreme Court and the Japanese IP High Court, affect patent litigation strategies and outcomes in Europe
• Tracking trends affecting the European market
• Exploring emerging trends on biosimilar entry, assessing their impact on market competition and innovation within the EU
• Understanding the role of Patents and Biosimilars in Europe
• Considering how European regulations and practices around biosimilar approval pathways, such as the ‘patent dance’, influence litigation timing and strategic decisions
• Discussing the resolution of biologic and biosimilar patent disputes in Europe, considering the influence of global practices
• Understanding the place of oppositions, national litigation, the UPC and dispute resolution within the EU context