The Local Division Düsseldorf is the first division of the UPC issuing a decision on the infringement of second medical use claims. In its landmark decision, it indicates the legal principles to apply, taking its own approach which might be inspired by but is still different from German case law [1].
The decision relates to a long-running multi-jurisdictional dispute over cholesterol-lowering medications: evolocumab, sold by Amgen under the brand name Repatha®, and alirocumab, sold by Sanofi/Regeneron under the brand name Praluent®. Both Repatha® and Praluent® are monoclonal antibodies used to treat and prevent ailments caused by high cholesterol levels.
Sanofi/Regeneron issued infringement proceedings against Amgen before the Local Division (LD) Düsseldorf, and Amgen counterclaimed for revocation.
The LD Düsseldorf noted that while the UPC’s legal framework for the assessment of direct patent infringement is set out in Article 25 of the UPC Agreement and Article 69 of the European Patent Convention, there are no statutory provisions regarding the infringement of second medical use claims – being purpose limited product claims –, and, at present, there is no established UPC case law.
Thus, the LD Düsseldorf was the first to develop a UPC approach. It found that there must be two elements:
(1) The alleged infringer must offer or place the medicinal product on the market in such way that it leads or may lead to the claimed therapeutic use of which the alleged infringer knows or reasonably should have known that it does (objective element).
(2) In addition, the infringer must know this or reasonably should have known (subjective element).
It emphasized that the requirements of such behavior cannot be defined in an abstract manner, but require an analysis of “all of the relevant facts and circumstances”. Relevant facts may include (para. 183):
- the extent or significance of the allegedly infringing use,
- the relevant market including what is customary on that market,
- the market share of the claimed use compared to other uses,
- what actions the alleged infringer has taken to influence the respective market,
- either ‘positively’, de facto encouraging the patented use,
- or ‘negatively’ by taking measures to prevent the product from being used for patented use.
The decision is the first and already as such very important for the UPC’s approach to the assessment of infringement of second medical use claims. The LD Düsseldorf’s approach might be inspired by but is still different from German case law. Unlike in German case law, the UPC’s approach does not expressly distinguish between liability based on manifest arrangement and liability without manifest arrangement but applies a broad analysis taking into account multiple factors, allowing a more flexible assessment. As the patent in suit has been upheld, Sanofi/Regeneron will likely file an appeal. A potential appellate decision addressing the fundamental issues concerning second medical use claims would be of significant importance: Such a ruling would not only provide legal clarity on the criteria for infringement of second medical use claims in UPC case law, but also offer guidance to national courts, and in particular to stakeholders across the pharmaceutical industry navigating the boundaries of second medical use patent protection.
Authors: Dr. Julia Traumann, Sebastian Ochs
[1] Sanofi vs. Amgen, LD Düsseldorf, 13.05.2025, https://www.unified-patent-court.org/sites/default/files/files/api_order/41D863BDF8522246D15222766D55D6B0_en.pdf; also dealing with validity which will not be discussed in this article.