Second Medical Use and Skinny Labelling: Building a Robust IP and Exclusivity Strategy

14 Oct 2026
IP & Regulatory Exclusivities

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 vs 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?
- How do second medical use claims and skinny labelling practice interact with competition law?

Speakers
Anna Wolters-Hohne
Anna Wolters-Hohne, Partner - Bird & Bird
Corinna Sundermann
Corinna Sundermann, Senior Vice President Intellectual Property - Fresenius Kabi
Eduardo Hallak
Eduardo Hallak, Founding Partner - Licks Attorneys
Markus Gruber
Markus Gruber, Head IP Solid Tumors and Radioligand Therapies - Novartis
Stefania Bergia
Stefania Bergia, Partner - Simmons & Simmons
Dexter Whitley
Dexter Whitley, Principal - Fish & Richardson