Case Law
Article 54: Novelty

Court of First Instance - Düsseldorf (DE) Local Division, Order dated 13/05/2025, Sanofi Biotechnologies SAS, Regeneron Pharmaceuticals Inc. v. Amgen Inc., Amgen GmbH, Amgen Europe B.V., Amgen NV, Amgen S.R.L., Amgen B.V., Amgen S.A.S. (Case/ Registry number: ACT_597355/2023, ORD_598583/2023)
Example of decision on novelty for a second medical use claim: "92. For (second) medical use claims, the novelty is not derived from the claimed substance or composition as such but from the claimed therapeutic use. 93. In the case of a second medical use, a substance or composition within the meaning of Art.54(4) EPC (for a use in a treating method = first medical use) is used for any specific use which is not comprised in the state of the art. Such a new 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. [...] 119. In order to benefit from the notional novelty afforded by Art. 54(5) EPC, second medical claims must relate to a specific use in a method according to Art. 53(c) EPC."

Court of First Instance - Munich (DE) Central Division - Section, Order dated 17/10/2024, NanoString Technologies Europe Limited v. President and Fellows of Harvard College (Case/ Registry number: UPC 252/2023, ORD_598480/2023)
Example of decision on the assessment of novelty: "3. The assessment of novelty within the meaning of Art. 54(1) EPC requires the determination of the whole content of the prior publication. It is decisive whether the subject-matter of the claim with all its features is directly and unambiguously disclosed in the prior art citation."