Judgement dated April 10, 2025 – UPC_CFI_505/2023, ACT_57355/2023 (Sanofi, Regeneron vs. Amgen)
The Local Division of Düsseldorf is the first UPC panel to set out the prerequisites and establish essential factors for assessing infringement of second medical use claims in the UPC system. Its approach builds on the criteria developed by national (German) courts. …
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Executive summary
In the high-stakes dispute Sanofi/Regeneron v. Amgen over its cholesterol-lowering drug Repatha®, the Court established requirements for the finding of infringement of second medical use claims. It must be demonstrated that:
- the product is marketed in such a way that it is or may be used according to the patent;
- the alleged infringer knows or should have known of such use.
The Court emphasizes that these requirements cannot be defined in an abstract manner but require an analysis of all relevant facts and circumstances of the case at hand.
In our up-to-the-minute IP Report, our expert team Johannes Heselberger, Nadine Westermeyer, Dr. Dominik Woll, and Dr. Axel B. Berger break down the background of the case, highlight its key takeaways, and discuss its practical relevance with regard to infringement.
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Johannes Heselberger Attorney-at-Law (Rechtsanwalt) & European Patent Attorney, UPC Representative, Partner |
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Nadine Westermeyer Attorney-at-Law (Rechtsanwältin), UPC Representative, Partner |
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Dominik Woll Attorney-at-Law (Rechtsanwalt), UPC Representative, Partner |
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Axel Berger German and European Patent Attorney, UPC Representative, Partner |
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