2025-05-13 - LD Düsseldorf - Sanofi v. Amgen - UPC_CFI_505/2023
- Aktenzeichen:
- UPC_CFI_505/2023
- Datum:
- Spruchkörper:
- Court of First Instance - Düsseldorf (DE) Local Division
- Art:
- Proceeding Decision
- Parteien:
- Sanofi Biotechnologies SAS v. Amgen Inc.
Kernaussage: The Düsseldorf Local Division dismissed both the infringement action and the counterclaim for revocation concerning EP 3 536 712 B1, a second medical use patent claiming PCSK9 inhibitors for reducing Lp(a) levels.
2025-05-13 - LD Düsseldorf - Sanofi
v.
Amgen - UPC_CFI_505/2023
landmark
The Düsseldorf Local Division dismissed both the infringement action and the counterclaim for revocation concerning EP 3 536 712 B1, a second medical use patent claiming PCSK9 inhibitors for reducing Lp(a) levels. On validity, the Court upheld the patent against all attacks: priority was validly claimed, novelty was affirmed under Art. 54(5) EPC, inventive step was upheld because the skilled person lacked motivation to implement PCSK9 inhibitors for Lp(a) reduction given the prevailing understanding that Lp(a) clearance was synthesis-driven and LDLR-independent, and sufficiency and added matter objections were rejected. On infringement, the Court established a novel framework requiring both an objective element (product placed on market leading or potentially leading to claimed use) and a subjective element (infringer knew or should have known), finding Sanofi/Regeneron failed to prove either.
Nichtigkeitsgründe
Art. 138 EPCNovelty
Patent survived (this ground)Art. 54 EPC · Art. 138(1)(a) EPC
“No prior art disclosed use of PCSK9 inhibitors for lowering Lp(a). Inherent effect does not destroy notional novelty under Art. 54(5) EPC.”
Inventive Step
Patent survived (this ground)Art. 56 EPC · Art. 138(1)(a) EPC
“Skilled person lacked motivation to implement: Lp(a) synthesis-driven, LDLR not Lp(a) clearance pathway, genetic evidence contra.”
Added Matter
Patent survived (this ground)Art. 123(2) EPC · Art. 138(1)(c) EPC
“Combination of features 4.2 and 4.3 directly disclosed in Table 3B of original application.”
Insufficiency of Disclosure
Patent survived (this ground)Art. 83 EPC · Art. 138(1)(b) EPC
“Table 3B showed 43.8% Lp(a) reduction vs placebo. Table 6 confirmed effect.”
Priority
Patent survived (this ground)Art. 87 EPC · derivative
“Combination disclosed in P1 as a whole. Narrowing to 30 mg/dL permissible.”