Agenda

Now a well-established and commercially critical facet of life science patent enforcement, litigation between branded biologics and biosimilar challengers continues to present challenges and questions centred on doctrinal interpretation, exclusivity rights and the fundamental scope of patent protection. This session reviews the latest innovator-biosimilar case law on both sides of the Atlantic and internationally, offering attendees practical guidance on defending exclusivity, challenging patent scope and navigating obstacles to market entry.  

- Examine key biosimilars disputes and case law across Europe, the U.S., Canada and key Asian jurisdictions, including Humira, Stelara, Eylea, Soliris, Prolia/Xgeva, Keytruda and Actemra/RoActemra. 

- Assess how innovators and biosimilars manufacturers are approaching launch timing and dispute strategy before the UPC, national European courts and in the U.S. under the BPCIA framework.  

- Discuss biosimilar launch strategies in the context of differing marketing authorisation pathways and timelines for exclusivity protection and regulatory approval across jurisdictions.