LD Munich, December 12, 2025, decision on infringement action and counterclaim for revocation, UPC_CFI_146/2024 et al

In its assessment of the inventive step, the Munich Local Division applied the test established by the CoA in its decisions Amgen v Sanofi (UPC_CoA_528/2024, 529/2024) and Meril v Edwards (UPC_CoA_464/2024 et al) decisions. These rulings were issued after the oral hearing had already been closed.

Without explicitly naming the principle of a fair trial, the Division considered whether it required the proceedings to be reopened. It held that the case could be decided based on the existing arguments and facts, as the applicable legal test had been, among other approaches like the EPO problem solution approach, discussed during the oral hearing. (decision, p. 29)

In its assessment of the “would” criterion for inventive step, the Munich Local Division, in principle, adopted the jurisprudence of the EPO Boards of Appeal regarding clinical trials. Accordingly, the fact that a clinical trial is nearing completion does not, per se, serve as a positive or negative pointer for the expectation of success in the absence of knowledge of the selected monitoring parameters.

Nevertheless, the Division considered that the trial in the present case had reached Phase III, had been approved, and had been in progress for three years at the priority date without interruption. This indicated that the sponsor had not regarded the trial as disappointing at its outset or at any time prior to the priority date. Thus, a person skilled in the art would have concluded that there was a reasonable prospect of success, which could guide them toward a particular course of action. (decision p. 41 et seqq.)