MUNICH CENTRAL DIVISION Law and Practice Contributed by: Julia Traumann and Ulrich Blumenröder, Grünecker
EPO, which is responsible for granting Euro - pean patents, the UPC retains the discretion to develop its own standards and build an inde - pendent body of case law. During the first two years of the UPC, several decisions addressing the assessment of inventive step were issued, including by the CD Munich. The Court of Appeal, so far, has provided only its first thoughts in its decision in NanoString v 10x Genomics (UPC_ CoA_335/2023, App_576355/2023, 26 February 2024), without setting general guidelines. This means the UPC’s approach remains to be seen, and, for the time being, it will continue to be dis - cussed widely. Sanofi/Regeneron v Amgen In its decisions delivered on 16 July 2024 in Sanofi/Regeneron v Amgen (UPC 1/2023, ACT 459505/2023; UPC 14/2023, C_586764/2023), the CD Munich established the potential position of the UPC on the patentability of therapeutic antibody inventions and defined its criteria for assessing inventive step. It is interesting to note that the CD Munich chose not to follow the problem-solution approach classically employed at the EPO by not starting from the closest prior art – ie, the most promis - ing prior art, but only from a “realistic starting point”, where there can be several realistic start - ing points. According to the CD Munich, a start - ing point is realistic if its teaching would have been of interest to a skilled person who, at the priority date of the patent at issue, was seek - ing to develop a similar product or method to that disclosed in the prior art, which thus has a “similar underlying problem” as the claimed invention (which appears not to be the same as the “objective technical problem” for the assess - ment of inventive step under the EPO approach). The CD Munich stated that, in general, a claimed solution is obvious if the skilled person was
motivated – ie, had an incentive, to consider the claimed solution and would implement it as a next step in developing the prior art. It may be relevant as to whether the skilled person would have expected any particular difficulties in tak - ing any next step(s). The CD Munich continued by saying that, depending on the facts and cir - cumstances of the case, it may be allowed to combine prior art disclosures. A technical effect or advantage achieved by the claimed sub - ject matter compared to the prior art may be, according to the CD Munich, an indication for inventive step. A feature that was selected in an arbitrary way out of several possibilities could not generally contribute to inventive step. The CD Munich emphasised that hindsight needs to be avoided. The question of inventive step should not be answered by searching retrospec - tively, with knowledge of the patented subject matter or solution, for any (combination) prior art disclosures from which that solution could be deduced. Against this background, the CD Munich revoked the patent in its entirety, finding that the person skilled in the art was motivated to develop thera - peutic antibodies against PCSK9 and that he/ she would have arrived at the claimed antibod - ies with a reasonable chance of success without an “undue burden” (in reference to the time and resources required). With this stance, the CD Munich deviated slightly from the EPO’s posi - tions on the assessment of inventive step. 3.2 Leading Cases Given the still-limited number of cases before the CD Munich, it remains challenging to identify clear “leading cases”. However, Sanofi/Regener - on v Amgen stands out as particularly notewor - thy – not only because of its unique procedural history before the UPC, but also due to its role in a long-standing, high-stakes dispute between
18
CHAMBERS.COM
Powered by FlippingBook