PRESS RELEASE
16 May 2025

Sanofi & Regeneron V Amgen: The UPC Weighs In On Infringement Of Second Medical Use Claims

JA
J A Kemp LLP

Contributor

J A Kemp is a leading firm of European Patent and Trade Mark Attorneys. We combine independent thinking with collective excellence in all that we do. The technical and legal knowledge that we apply to the protection of our clients’ patents is outstanding in its breadth and depth. With around 100 science and technology graduates in the firm, including 50 PhDs, no area of science or technology is outside our scope. Our Patent Attorneys have collective in-depth expertise in patent law and procedure in every country of the world. The team of professionals who advise our clients on trade mark and design matters have backgrounds in major international law firms and hold qualifications as Chartered UK Trade Mark Attorneys, Solicitors and European Trade Mark Professional Representatives. Dedicated to this specialist area of intellectual property protection, the team has the expertise and resources to protect trade marks and designs in any market worldwide.
The UPC has issued its first decision concerning the infringement of second medical use claims. The decision arises from the long-running dispute between Sanofi/Regeneron and Amgen in the anti-PCSK9 antibody space.
United States

The UPC has issued its first decision concerning the infringement of second medical use claims. The decision arises from the long-running dispute between Sanofi/Regeneron and Amgen in the anti-PCSK9 antibody space.

In the decision, the Düsseldorf Local Division has adopted a patentee-friendly "foreseeability" test, whereby infringement can be found if the generic manufacturer "knows or reasonably should have known" that their product would be used for the patented indication. This marks a notable shift from the more conservative stance traditionally taken by some European national courts.

A more detailed discussion of the decision, surrounding issues and potential future implications can be found in our briefing here.

Contributor

J A Kemp is a leading firm of European Patent and Trade Mark Attorneys. We combine independent thinking with collective excellence in all that we do. The technical and legal knowledge that we apply to the protection of our clients’ patents is outstanding in its breadth and depth. With around 100 science and technology graduates in the firm, including 50 PhDs, no area of science or technology is outside our scope. Our Patent Attorneys have collective in-depth expertise in patent law and procedure in every country of the world. The team of professionals who advise our clients on trade mark and design matters have backgrounds in major international law firms and hold qualifications as Chartered UK Trade Mark Attorneys, Solicitors and European Trade Mark Professional Representatives. Dedicated to this specialist area of intellectual property protection, the team has the expertise and resources to protect trade marks and designs in any market worldwide.

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