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Second Medical Use and Skinny Labelling: Building a Robust IP and Exclusivity Strategy
Second medical use patents remain one of the most commercially sensitive tools in the originator playbook. Yet they are among the most volatile of protection mechanisms when it comes to validity challenge and “skinny labelling” carve-out strategies.
This session will explore the latest case law updates and patentability challenges in the European, U.S., and Brazilian second medical use and skinny labelling spaces, covering new strategies for building and attacking these patents.
- What are the key implications of recent second medical use case law, including the landmark UPC Local Division ruling on Amgen v Sanofi (2024)?
- What is the current EPO stance on reasonable expectations of success for second medical use?
- How should companies approach plausibility and data requirements in Europe post G2-21?
- How has the UPC shaped strategy around second medical use claims?
- What does the U.S. Supreme Court decision in Hikma v Amarin reveal about the future of skinny labelling practice?
- How is the approach to second medical use patents evolving in Brazil, and what do INPI’s new examination guidelines mean for patentability and enforcement strategies?
- How do second medical use claims and skinny labelling practice interact with competition law?
