Sanofi Biotechnology v Amgen (CFI, 13 May 2025)

Dhenne Avocats · 10 October 2026

Our analysis

Summary

In a decision of 13 May 2025 (UPC_CFI_505/2023), the Düsseldorf Local Division considers Regeneron’s EP 3 536 712 B1, which claims a composition comprising a PCSK9 inhibitor for use in reducing lipoprotein(a) (Lp(a)) levels, asserted together with its exclusive licensee Sanofi Biotechnology against seven Amgen group companies in respect of Repatha (evolocumab). The counterclaim for revocation is admissible but unfounded, and so is the infringement action (paragraph 67). The decision matters to practitioners on two counts: it confirms that a second medical use claim may be directed at a new patient group and withstand an obviousness attack, and it sets a demanding test for infringement of such a claim where the product is authorised for a different indication.

Facts and procedure

Claim 1 covers patients with a serum Lp(a) level above 30 mg/dL who have, or are at risk of, cardiovascular or thrombotic occlusive disease and are not on a therapeutic statin regimen, the inhibitor being an antibody that specifically binds PCSK9. The claimants targeted five States. The defendants counterclaimed for revocation, Regeneron filing five auxiliary requests.

The applicable law

The Division applies Art. 47 UPCA on standing, Arts 54(5), 56, 83, 87 and 123(2) EPC on validity, Art. 25 UPCA on infringement, and Rule 171.2 RoP on contesting facts.

Question

Is a second medical use claim limited to reducing Lp(a) in a defined patient group valid over the prior art, and when does marketing a medicine authorised for lowering LDL cholesterol infringe it?

Decision

Both claimants have standing: the proprietor under Art. 47(1) UPCA, without having to show any particular interest, and the exclusive licensee under Art. 47(2) (paragraphs 69 to 73). Contesting facts by pleading ignorance, a device drawn from German procedural law, is disregarded under Rule 171.2 (paragraph 74). Reducing Lp(a) is a distinct therapeutic use, and the claim excludes use solely for lowering LDL cholesterol. The Lp(a) threshold of 30 mg/dL must be objectively met, and the physician’s knowledge is not required (paragraphs 97 to 109). Priority is validly claimed (paragraphs 112 to 117), the claim is novel (paragraphs 120 to 126) and inventive: prevailing views on Lp(a) synthesis and the role of the LDL receptor deprived the skilled person of any motivation (paragraphs 144 to 159). The disclosure is sufficient, the defendants having raised no serious, substantiated doubts (paragraphs 166 to 170). On infringement, the product must be offered or placed on the market in a way that leads or may lead to the claimed use, and the infringer must know or reasonably should know this (paragraphs 180 to 184). The claimants did not prove such use: the SmPC lists only LDL cholesterol lowering and mixed dyslipidaemia, the Lp(a) reduction of about 25% reported in section 5.1 does not show prescription for that purpose, and no marketing aimed at the claimed use was shown (paragraphs 185 to 191). Nor is a likelihood of prescription to reduce Lp(a) shown: the claimants’ expert speaks only of an expectation, contradicted by the defendants’ experts, and a raised Lp(a) level at most leads to stricter LDL-C control, the hurdles to off-label prescription reinforce that finding (paragraphs 192 to 198). The subjective element and the 30 mg/dL threshold are not established (paragraph 199). The claimants bear the costs of the infringement action, the defendants those of the counterclaim. The value in dispute is EUR 20 million for infringement and EUR 25 million for revocation, and the ceiling for recoverable costs EUR 1,875,000 (paragraphs 202 and 203).

Key points for practice

• A second medical use claim derives its patentability solely from the novelty and inventiveness of the use. A new patient group can be enough (paragraphs 97 to 126).
• Uncertainties or anticipated difficulties may remove the skilled person’s motivation and support inventive step (paragraphs 144 to 152).
• Pleading ignorance is not recognised before the UPC: facts must be contested with reasons (paragraph 74).
• Practical point: against a product authorised for another indication, the proprietor must prove marketing directed at the claimed use (labelling, promotion, prescribing practice), a side effect described in the SmPC is not enough (paragraphs 185 to 191).

Provisions applied

Agreement on a Unified Patent Court

Arts 25, 47, 54, 65 and 69

Rules of Procedure

Rules 9.2, 25.1, 44, 118.5, 152.2 and 171.2

European Patent Convention

Art. 54, Art. 56, Art. 69, Art. 83, Art. 87, Art. 123

Case law cited

NanoString v 10x Genomics, Court of Appeal, 26 February 2024, VusionGroup v Hanshow, Court of Appeal, 13 May 2024, Abbott v Sibio, Court of Appeal, 14 February 2025, Sanofi v Amgen, Munich Central Division, 16 July 2024, NanoString v Harvard College, Munich Central Division, 17 October 2024, Fujifilm v Kodak, Düsseldorf Local Division, 28 January 2025, Kaldewei v Bette, Düsseldorf Local Division, 3 July 2024

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.