2025-05-13 - LD Düsseldorf - Sanofi v. Amgen - UPC_CFI_505/2023

1. In the case of a second medical use claim, a substance or composition within the meaning of Art. 54(4) EPC is used for any specific use which is not comprised in the state of the art. Such a therapeutic use can be a new indication, e.g. a disease not yet treated by the claimed substance, or an indication for a new group of patients. 2. For a finding of infringement of a second medical use claim, the alleged infringer must offer or place the medical 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. The requirements of such behaviour cannot be defined in an abstract manner but require an analysis of all relevant facts and circumstances of the patent claim in question. 3. In order to benefit from the notional novelty afforded by Art. 54(5) EPC, second medical use claims must relate to a specific use in a method according to Art. 53(c) EPC. The sole reason why such claims can still be patented is the novelty (and inventiveness) of the new use. 4. In terms of inventive step, the subject matter of the claim may be obvious if the skilled person would have been motivated to implement it as the next step in the view of the problem. A motivation to implement may be absent or negated if the skilled person is faced with many uncertainties or expected difficulties. If there is no motivation at all or a negated motivation, the subject matter of the claim is not obvious and involves an inventive step. 5. Objections based on pleading ignorance are in principle disregarded. The Rules of Procedure of the Unified Patent Court do not acknowledge this type of pleading.

The Düsseldorf Local Division dismissed the infringement action as well as the corresponding counterclaim for revocation. The Court went into details regarding the parties' validity arguments. [To be amended]