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?
Anna Wolters-Höhne
I am a highly experienced patent litigator with 20 years of expertise representing clients across all industry sectors in international patent disputes, with a particular focus on life sciences. I have been involved in several landmark patent cases and important innovator vs. innovator disputes.
My practice encompasses patent infringement and damages proceedings, nullity actions, compulsory licence cases before the German courts, opposition proceedings before the European Patent Office, and UPC advice. I am frequently involved in the coordination of complex, multi-jurisdictional cases through an extensive international network of counsel, patent attorneys, and technical, economic, and legal experts. With my significant litigation expertise, I have secured landmark preliminary injunction victories in the pharmaceutical and medical devices fields.
I also advise clients on the development of both offensive and defensive patent strategies for clients across all sectors. Clients value my responsiveness, commercial awareness, reliability, and commitment to achieving results. For me, success is a team effort: My "one team approach" includes not only my highly qualified team here in my office, but also each person who works on the case globally, whether it is a lawyer, patent attorney, or assistant from our Bird & Bird network or from a competitor. Most importantly, the client with their expertise is at the centre of I - we focus all our energy on winning the case together as one team.
Corinna Sundermann
Dexter Whitley
Dexter Whitley, Ph.D., a member of Fish & Richardson’s litigation team, works on complex patent cases involving a range of technical areas, with a particular focus on life sciences, pharmaceuticals, biotechnology, and Hatch-Waxman litigation. Dexter is experienced in multiple stages of litigation, from pre-case assessment and due diligence investigations through witness preparation and examination. He is a critical team member in district court litigation and in post-grant matters before the Patent Trial and Appeal Board. A former professor of molecular biology, immunology, and physiology at Tougaloo College, Dexter readily understands the complex technologies underlying his clients’ inventions, communicates well with scientists and inventors, and explains scientific concepts in clear and simple terms for corporate leaders, lay judges, and juries.
Eduardo Hallak
Eduardo Hallak is one of the founding partners at Licks Attorneys and one of our leaders at the Sao Paulo office. For more than a decade, he has been working as a litigator before state and federal courts in Brazil in several complex disputes and leading cases involving Patent law, competition, and regulatory compliance, most of them pursuing the interests of clients in the area of life sciences. He also has extensive practice in trademark litigation as well as technology transfer contracts, working together with multinational clients to establish strong brand protection and licensing programs in the country. Mr. Hallak also currently teaches IP litigation in the Post-Graduation course at the prestigious Pontifical Catholic University of Rio de Janeiro (PUCRJ), has taught Civil Procedure at the at the Brazilian Association of IP Agents (ABAPI), and is often invited to lecture on procedural and strategic aspects of IP litigation, in addition to being a member of the Special Commission on Mediation of the Rio de Janeiro Chapter of the Brazilian Bar Association (OABRJ) and the Enforcement Committee of INTA.
Markus Gruber
