Düsseldorf, May 20, 2025 - The Unified Patent Court (UPC), Local Division Düsseldorf, issued a pivotal ruling on May 13, 2025 in the Sanofi v. Amgen case (UPC_CFI_505/2024) addressing critical aspects of second medical use claims under Articles 53(c), 54(4), and 54(5) of the European Patent Convention (EPC) and infringement under the UPC Agreement (UPCA). It is the first UPC decision on second medical use claims, and therefore provides important guidance for the Life Sciences sector.
The court ruled that second medical use claims require a new therapeutic application—such as a novel indication or treatment for a new patient group—not disclosed in the prior art. Infringement can occur when an alleged infringer markets a medical product in a manner that leads or may lead to the protected therapeutic use of which the alleged infringer knows or reasonably should have known that it does. This assessment demands a detailed analysis of all relevant facts and circumstances specific to the patent claim. Relevant facts may include
- 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 court also clarified that objections based on pleading ignorance are generally disregarded, as the UPC Rules of Procedure do not recognise this defence.
On novelty, the court emphasized that second medical use claims can be novel under Art. 54(5) EPC only if they relate to a specific use in a method under Art. 53(c) EPC. The patentability of such claims depends on the novelty and inventiveness of the new use. For inventive step, the court noted that a claimed medical use is obvious if a skilled person would have been motivated to pursue it as the next logical step. However, motivation may be absent if significant uncertainties or anticipated difficulties exist, rendering the claim non-obvious and inventive.
While only a first instance ruling that can be expected to be appealed, the decision provides important guidance regarding second medical use patents for innovators and stakeholders in the Life Sciences sector.
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