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Treatment-Related Secondary Patent Litigation: Reviewing European and Hatch-Waxman Enforcement Trends in Innovator-Generic Disputes
With innovator companies continuing to reinforce protection beyond active pharmaceutical ingredient (API) and composition-of-matter IP, innovator-vs-generic disputes surrounding treatment-related secondary patents remain central to life science patent litigation dynamics. Covering second medical use claims, dosing regimens, skinny labelling and carve-out strategies, this session reviews the European and Hatch-Waxman landscapes for treatment-related secondary patent enforcement, and what recent developments mean for innovators and generic challengers navigating market entry.
- Review recent European innovator-generics case law in the treatment-related secondary patent space, including second medical use litigation and dosing regimen enforcement.
- Explore international challenges relating to carve-out strategies and litigating around induced and contributory infringement.
- Discuss the Hikma v Amarin skinny labelling decision from the U.S. Supreme Court and its implications for future litigation strategy.
- Examine how the cabazitaxel and fulvestrant disputes are shaping the European treatment of second medical use patents, from UPC and EPO validity challenges to enforcement questions arising in national courts.
- Compare the evolving boundaries of generic entry and treatment-related secondary patent enforcement across the UPC, Germany, the UK and the U.S.
