Sanofi-Aventis Deutschland v Amgen (CFI, 16 July 2024)

Dhenne Avocats · 10 October 2026

Our analysis

Summary

In a decision on the merits of 16 July 2024, the Munich Central Division ruled on the revocation action brought by Sanofi-Aventis Deutschland GmbH, Sanofi-Aventis Groupe and Sanofi Winthrop Industrie S.A. (UPC_CFI_1/2023), joined with Regeneron Pharmaceuticals’ counterclaim, against Amgen’s EP 3 666 797, which protects, in medical use format, a monoclonal antibody binding to the catalytic domain of PCSK9 and preventing or reducing its binding to the LDLR, for the treatment of hypercholesterolaemia. The Division held the patent as granted to lack inventive step over the Lagace article, and auxiliary requests 1 to 17 to fail for the same reasons (paragraph 4.1). The decision is of interest for its method: several realistic starting points may coexist without the most promising one having to be identified, and it is enough that the skilled person would arrive, without inventive contribution, at a result falling within the claim. For functionally defined antibody claims, it shows that a validated target and routine screening techniques may be enough to deny inventive step. The patent was revoked in its entirety for the seventeen States concerned and Amgen bears the other side’s costs, set at EUR 1.375 million, an amount agreed between the parties.

Facts and procedure

On 1 June 2023 the Sanofi companies brought a revocation action before the Central Division (ACT_459505/2023, UPC_CFI_1/2023), while Amgen brought an infringement action before the Munich Local Division (ACT_459916/2023), in which Regeneron counterclaimed for revocation. The Munich Local Division referred Regeneron’s counterclaim (CC_586764/2023) to the Central Division on 2 February 2024 with the parties’ agreement, and the two proceedings were joined by orders of 27 February 2024 (paragraphs 1.3 and 1.4). The decisions, in substance identical, were issued on the same day in both cases (paragraph 1.5). The claimants sought revocation for seventeen States. Amgen sought dismissal and, in the alternative, maintenance on one of auxiliary requests 1 to 17. Oppositions have also been filed at the EPO.

The applicable law

Claims are construed within the framework laid down by the Court of Appeal in NanoString v 10x Genomics and VusionGroup v Hanshow: technical meaning of the terms, read in the light of the description and drawings (paragraphs 6.3 and 6.6), the headnotes add that the description may act as the patent’s own lexicon. Priority requires the claimed subject matter to be directly and unambiguously derivable from the earlier application (Article 87 EPC, paragraph 7.6). Inventive step is assessed under Article 56 EPC.

Question

Is an antibody claim defined by its target and function inventive where the prior art identified PCSK9 as a target and producing antibodies was routine?

Decision

The catalytic domain means residues 123 to 419 of SEQ ID NO: 1, and the claim does not require binding exclusively within that domain (paragraphs 6.12 to 6.18). The patent is entitled to priority from P3 of 9 January 2008, so documents C1 and C2 are not prior art under Article 54(3) EPC (paragraphs 7.7 to 7.14). Lagace is a realistic starting point, and the Division need not decide whether Graham was more promising (paragraphs 8.6, 8.12, 8.27 and 8.28). Starting from Lagace, and given the strong incentive to find a PCSK9 inhibitor, developing antibodies blocking PCSK9 binding to the LDLR was the obvious next step, and producing them was routine (paragraphs 8.31 to 8.34, 8.54 and 8.55). Whether a reasonable expectation of success is required was left open. A lack of such expectation does not follow merely from other approaches having been suggested or pursued (paragraphs 8.56 and 8.57). It suffices that the skilled person would arrive, without inventive contribution, at a result within the claim (paragraphs 8.66 and 8.67). Antibodies obtained by screening against the full PCSK9 protein would in all likelihood bind to the catalytic domain, and that feature, with no causal link to the therapeutic effect, is an arbitrary choice among three domains that cannot support inventive step (paragraphs 8.77 and 8.78), the uncertainties raised by Amgen did not outweigh the clear incentive given by Lagace (paragraphs 8.80 to 8.82). Dependent claims 2 to 11 fall with claim 1 (paragraph 9.1). The application to amend is admissible (Rules 30.1 and 50 RoP), but none of auxiliary requests 1 to 17, filed to meet added matter and priority objections, was substantiated on inventive step. Under Article 76 UPCA they fail for the same reasons (paragraphs 9.2 to 9.7). The patent is revoked in its entirety for Austria, Belgium, Bulgaria, Denmark, Estonia, Finland, France, Germany, Italy, Latvia, Lithuania, Luxembourg, Malta, the Netherlands, Portugal, Slovenia and Sweden, without examination of the other grounds (paragraphs 9.8 and 10.1). With the value of the case set at EUR 100 million, the ceiling for recoverable representation costs is EUR 2 million, the Division accepted the amount of EUR 1.375 million per action agreed between the parties and ordered Amgen to pay it (Article 69 UPCA and Rule 118.5 RoP, paragraphs 11.1 and 11.2).

Key points for practice

• Several realistic starting points may exist. The invention must be inventive over each of them (paragraph 8.28).
• The Division left open whether a reasonable expectation of success is required where the incentive exists and the next steps are routine (paragraph 8.56).
• Auxiliary requests filed to meet other objections, with no explanation on inventive step, fall with the main request, as the Division cannot make the parties’ case for them (Article 76 UPCA, paragraph 9.7).
• Practical point: a purely functional antibody claim is vulnerable where the target is known and obtaining the antibody requires only standard techniques, the defence must establish a technical contribution of its own.

Provisions applied

Agreement on a Unified Patent Court

Arts 54, 65(1) and (2), 69 and 76

Rules of Procedure

Rules 25.1, 30.1, 44, 50 and 118.5

European Patent Convention

Art. 54, Art. 56, Art. 69, Art. 87, Art. 88, Art. 89, Art. 138(1)

Case law cited

NanoString v 10x Genomics, Court of Appeal, 26 February 2024, VusionGroup v Hanshow, Court of Appeal, 13 May 2024, EPO Enlarged Board of Appeal, G 2/98, 31 May 2001

Prepared by Dhenne Avocats from the official decision, consulted on 10 October 2026. The database is updated every week, on Friday. Only the official text is authoritative.