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