CC 586764/2023
Nov 10, 2023·EP3666797 · ANTIGEN BINDING PROTEINS TO PROPROTEIN CONVERTASE SUBTILISIN KEXIN TYPE 9 (PCSK9)
- Case details
- StatusCase Closed (Patent revoked)ActionCounterclaim for revocationCategoryCounterclaim for revocation
- Parties
- Claimants
- Regeneron Pharmaceuticals Inc.Operating co.
Representatives- Niels Hoelder-Hoffmann Eitle
- Agathe Michel-De Cazotte-Carpmaels & Ransford
- Daniel Wise-Carpmaels & Ransford
- Emily Nikolić-Carpmaels & Ransford
- Gregor König-König Szynka - Tilmann - Von Renesse
Respondents- Amgen Inc.Operating co.
Representatives- Johannes Heselberger-Bardehle Pagenberg
- Koen Bijvank-Brinkhof
- Daan de Lange-Brinkhof
- Rik Lambers-Brinkhof
- Jonathan Santman-Brinkhof
- Roza Rijpkema-Brinkhof
- Axel Berger-Bardehle Pagenberg
- H. Ulrich Dörries-df-mp
- Division
- Munich CD
- Technology
- ChemistryBiotechnology · Pharmaceuticals
- Language
- English
- First decided
- Jul 16, 2024
- EPO Opposition
- Sanofi-Aventis Deutschland GmbHAdmissible2023-11-10
- REGENERON PHARMACEUTICALS, INC.Admissible2024-02-19
- Sanofi-Aventis Groupe S.A.Withdrawn2023-11-10
- Sanofi Winthrop Industrie S.A.Withdrawn2023-11-10
| Patent revoked | Median days to first decision | |
|---|---|---|
| All UPC | 37% (34/91) | 124 |
| Munich CD | Locked | Locked |
| Judge Ulrike Voß | Locked | Locked |
| Judge András Kupecz | Locked | Locked |
| Judge Casper Struve | Locked | Locked |
At the UPC: Regeneron Pharmaceuticals Inc. (9 cases)·Amgen Group (19 cases)
This dispute contains 3 other proceedings
3 other defendants litigating the same or a related patent
- 2024-07-16Counterclaim for revocationPublic
Summary: The patent EP 3 666 797 B1 was revoked in its entirety for all Contracting Member States in which revocation was requested. The Main Request and all 17 Auxiliary Requests were found to lack inventive step. The defendant (patent proprietor Amgen) was ordered to bear the claimant's legal costs, agreed at EUR 1.375 million.
Show the legal issues (5)
- Claim interpretation
- Priority (Article 87 EPC)
- Inventive step (Article 56 EPC)
- Arbitrary selection
- Technical effect as indication of inventive step
| Document title | Date | Public |
|---|---|---|
| Procedural Order App_47154/2024 | 2024-10-23 | Not public |
| Final Order anonymised | 2024-07-16 | Not public |
| DecisionOutcome | 2024-07-16 | Not public |
| decision revocation counterclaim 14/2023 | 2024-07-16 | Public |
| decision revocation counterclaim 14/2023 | 2024-07-16 | Not public |
| Announcement | 2024-07-04 | Public |
| Recording of Oral Hearing - Placeholder | 2024-06-06 | Not public |
| Recording of Oral Hearing - Placeholder | 2024-06-06 | Not public |
| interimProcedureClosure | 2024-05-22 | Not public |
| Receipt | 2024-05-13 | Not public |
Regeneron Pharmaceuticals brought a revocation counterclaim against Amgen's EP 3 666 797 B1 (anti-PCSK9 antibody patent) before the Central Division (Munich Section). The Central Division revoked the patent in its entirety over 17 contracting member states, finding that Amgen's Main Request and all 17 Auxiliary Requests lacked inventive step; Amgen was ordered to bear Regeneron's legal costs agreed at EUR 1.375 million, against a case value of EUR 100 million.
EP 3 666 797 B1 (anti-PCSK9 antibody) lacks inventive step over the prior art
ClaimantLegal basis: Art. 56 EPC; Art. 138(1)(a) EPC; Art. 65(2) UPCANote: Regeneron's inventive step attack succeeded against Amgen's Main Request and all 17 Auxiliary Requests; multiple realistic starting points were identified in the prior art.
EP 3 666 797 B1 Main Request and all 17 Auxiliary Requests are valid and inventive
RespondentLegal basis: Art. 56 EPC; Art. 76 UPCAReason: All 17 auxiliary requests lacked inventive step for the same reasons as the Main Request; the Central Division applied Art. 76 UPCA (decisions on merits only on submitted grounds) and found no valid form of the patent.
Browse other cases on this principle.
- prior art starting points in the anti-PCSK9 antibody field (multiple realistic starting points identified by Central Division)Obviousness combination
EP 3 666 797 B1 claims antigen-binding proteins directed to PCSK9. The Central Division interpreted claim terms using their technical meaning for the skilled person in the antibody/cholesterol-lowering field, with the patent description serving as a lexicon for specialised terms. Priority validity was also assessed: the claimed subject-matter had to be derivable directly and unambiguously from the priority application using common general knowledge.