This session provides an in-depth analysis of recent high-profile biologics and biosimilar patent disputes across Europe, the USA, and Asia, including landmark cases involving Xtandi, Soliris, and antibody exclusivity challenges. Attendees will explore how evolving case law, patent claim constructions, and regulatory developments are shaping exclusivity periods, enforcement strategies, and market entry pathways. The session will also address comparative litigation trends, strategic patent considerations, and the complexities of navigating both branded vs branded and biosimilar patent conflicts globally.
• Examine key European rulings on Xtandi and Soliris patents, including patent validity challenges and injunction decisions.
• Analyse evolving antibody patent standards post-G2/21, Amgen vs Sanofi, and their impact on inventive step and exclusivity in the US and Europe.
• Explore strategic insights on BPCIA litigation timing, branded vs branded biologics disputes, and regulatory pathways for biosimilar market entry.
James Holtom
Peter van Schijndel
Selma Ünlü
Martina Hufnal
Gemma Barrett
Gemma is an experienced and trusted advisor for some of the world’s leading life sciences and chemical companies. Her background in biochemistry means she specialises in complex technical disputes in the life sciences sector. She has more than fifteen years’ experience advising clients in patent litigation matters before the English Courts including securing preliminary injunctions. She is also experienced in advising on global cross-border litigation, and coordinating worldwide litigation, working closely with multi-disciplinary teams in the defence and enforcement of patent portfolios. She has developed innovative and successful strategies, often combining patent and regulatory law, to assist pharmaceutical companies in the enforcement of their rights.