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UPC – Sanofi and Regeneron v. Amgen / First revocation judgments

16 Jul 2024

Sanofi-Aventis Deutschland GmbH, Sanofi-Aventis Groupe and Sanofi Winthrop Industrie S.A. v. Amgen, Inc Action no. UPC 1/2023 (Revocation action) and Regeneron Pharmaceuticals Inc.v. Amgen Inc. and UPC Action no. 14/2023 (Counterclaim for revocation) Court of First Instance of the UPC Central division (Section Munich), 16 July 2024

The Central Division Munich Section has today delivered its first judgments in revocation proceedings. The Central Division revoked EP 3 666 797 B1 (for Amgen’s cholesterol lowering drug marketed under the name Repatha) in its entirety due to a lack of inventive step.

The judgments mainly contain statements on the interpretation of a patent, on the term “same invention” within the meaning of Art. 87 EPC and on the principles on the basis of which inventive step is to be examined.

The judgments can be read here and here.

HEADNOTES:
1. When interpreting a patent claim, the person skilled in the art does not apply a philological understanding, but determines the technical meaning of the terms used with the aid of the description and the drawings. From the function of the individual features in the context of the patent claim as a whole, it must be deduced which technical function these features actually have individually and as a whole. The patent description may represent a patent´s own lexicon.

2. A claimed invention is to be considered the “same invention” as meant in Article 87 EPC (priority right) if the skilled person can derive the subject-matter of the claim directly and unambiguously, using common general knowledge, from the previous application as a whole.

3. The assessment of inventive step starts from a realistic starting point in the prior art. There can be several realistic starting points. It is not necessary to identify the “most promising” starting point.

4. In general, a claimed solution is obvious if the skilled person would be motivated to consider the claimed solution and would implement it as a next step in developing the prior art. It may be relevant whether the skilled person would have expected any particular difficulties in taking any next step(s). The absence of a reasonable expectation of success (or more in general: non-obviousness) does not follow from the mere fact that other ways of solving the underlying problem are also suggested
in the prior art and/or (would) have been pursued by others. The decisive question that has to be answered is whether the claimed solution is non-obvious.

5. For assessing inventive step it is not the question whether the skilled person would inevitably arrive at the same result (falling within the scope of the claim or not). Rather, it is sufficient (but also necessary) for denying inventive step that the skilled person would without inventive contribution arrive at a result which is covered by a claim.

6. A technical effect or advantage achieved by the claimed subject matter compared to the prior art may be an indication for inventive step. A feature that is selected in an arbitrary way out of several possibilities cannot generally contribute to inventive step.

[Further comment follows]