2024-07-16 - CD Munich - Sanofi v. Amgen - UPC_CFI_1/2023
- Aktenzeichen:
- UPC_CFI_1/2023
- Datum:
- Spruchkörper:
- Court of First Instance - Munich (DE) Central Division - Section
- Art:
- Proceeding Decision
- Parteien:
- Sanofi-Aventis Deutschland GmbH v. Amgen, Inc.
Kernaussage: The Munich Central Division revoked Amgen's PCSK9 antibody patent EP 3 666 797 B1 entirely for 17 UPC Contracting Member States on the Sanofi parties' revocation action, heard jointly with Regeneron's counterclaim for revocation (UPC_CFI_14/2023).
2024-07-16 - CD Munich - Sanofi
v.
Amgen - UPC_CFI_1/2023
landmark
The Munich Central Division revoked Amgen's PCSK9 antibody patent EP 3 666 797 B1 entirely for 17 UPC Contracting Member States on the Sanofi parties' revocation action, heard jointly with Regeneron's counterclaim for revocation (UPC_CFI_14/2023). The Court held the claimed subject-matter obvious over Lagace 2006: Lagace explicitly suggested that antibodies blocking the PCSK9/LDLR interaction could be explored for treating hypercholesterolemia, and the skilled person would have followed that suggestion with a reasonable expectation of success, using routine antibody-generation techniques. The feature 'binds to the catalytic domain' was held to be an arbitrary selection out of three PCSK9 domains, not contributing to inventive step. In its elaborated inventive-step framework, the Court held: a realistic starting point is sufficient (no need to identify the 'most promising'); obviousness turns on motivation to take the claimed solution as a next step; absence of reasonable expectation of success does not follow merely from the fact that other prior-art routes were also pursued; and the test is not whether the skilled person would inevitably reach the claimed result but whether they would without inventive contribution arrive at a result covered by the claim. On priority, the Court confirmed the G-2/98 'same invention' standard and held P3 valid — the catalytic-domain definition was already directly and unambiguously derivable from P3. Auxiliary Requests 1–17 fell with the Main Request. Costs: 1.375M EUR per action, value 100M EUR.
Nichtigkeitsgründe
Art. 138 EPCNovelty
Patent survived (this ground)Art. 54 EPC · Art. 138(1)(a) EPC
“Novelty attack under Art. 54(3) EPC based on C1 and C2 fails because the Patent validly claims P3's priority [7.14].”
Inventive Step
Patent invalid (this ground)Art. 56 EPC · Art. 138(1)(a) EPC
“Main Request and all 17 auxiliary requests held obvious over Lagace (C3); Lagace explicitly suggests antibody development blocking PCSK9/LDLR interaction; 'binds to catalytic domain' is an arbitrary selection [8.11-8.82, 9.7].”
Added Matter
Not decidedArt. 123(2) EPC · Art. 138(1)(c) EPC
“Added-matter objections raised but not decided on Main Request because revocation follows from lack of inventive step; auxiliary requests addressing added-matter fall with the MR [9.7, 9.8].”
Insufficiency of Disclosure
Not decidedArt. 83 EPC · Art. 138(1)(b) EPC
“Insufficiency attack raised but not decided — inventive step is decisive [9.8].”
Priority
Patent survived (this ground)Art. 87 EPC · derivative
“Patent validly claims priority from P3 (9 January 2008) under the G-2/98 'same invention' standard; Figure 26 added in P4 is illustrative, not definitional [7.7-7.13].”