UPC CoA 529/2024
Sep 13, 2024·EP3666797 · ANTIGEN BINDING PROTEINS TO PROPROTEIN CONVERTASE SUBTILISIN KEXIN TYPE 9 (PCSK9)
- Case details
- StatusCase Closed (Patent upheld as granted)ActionAppealCategoryMain appeal
- Parties
- Claimants
- Amgen Inc.Operating co.
Representatives- Johannes Heselberger-Bardehle Pagenberg
- Koen Bijvank-Brinkhof
- Not named-Bardehle Pagenberg
Respondents- Regeneron Pharmaceuticals Inc.Operating co.
Representatives- Niels Hoelder-Hoffmann Eitle
- Daniel Wise-Carpmaels & Ransford
- Division
- Court of Appeal
- Technology
- ChemistryBiotechnology · Pharmaceuticals
- Language
- English
- First decided
- Nov 25, 2025
- Last decision
- Mar 25, 2026
- 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
| Median days to first decision | |
|---|---|
| All UPC | 124 |
| Judge Klaus Grabinski | Locked |
| Judge Nathalie Sabotier | Locked |
| Judge Peter Blok | Locked |
At the UPC: Amgen Group (19 cases)·Regeneron Pharmaceuticals Inc. (9 cases)
This dispute contains 3 other proceedings
3 other defendants litigating the same or a related patent
Start a free trial to see how each one ended.
More cases: Court of Appeal·2024
- 2026-03-25Withdrawal (RoP265)Public
Summary: Sanofi and Regeneron withdrew their application for rehearing (R.245 RoP) concerning the Court of Appeal's decision of 25 November 2025 (UPC_CoA_528/2024 and UPC_CoA_529/2024) which had rejected the revocation of EP 3 666 797 and set aside the Central Division Munich's first-instance decision. The application for withdrawal was permitted. The decision covers both UPC_CoA_528/2024 and UPC_CoA_529/2024. Court fees were to be reimbursed accordingly.
Show the legal issues (2)
- Withdrawal of application for rehearing under R.245 RoP
- Reimbursement of court fees under R.370.9 RoP
- 2026-02-18
Summary: The Court of Appeal (Panel with Klaus Grabinski, Nathalie Sabotier, Peter Blok) rejected Sanofi and Regeneron's application for suspensive effect concerning the Court of Appeal's own decision of 25 November 2025 which had rejected the requests for revocation of EP 3 666 797. Sanofi and Regeneron sought suspensive effect as part of a petition for rehearing (R. 220.4 RoP). The court found no basis to suspend a revocation-rejection decision (as this had no practical effect on the patent's validity status), and rejected the claim that the CoA's reasoning on claim interpretation and inventive step was based on issues not argued by the parties.
Show the legal issues (4)
- Suspensive effect in connection with petition for rehearing (R. 220.4 RoP)
- Revocation action - patent maintained by CoA on appeal
- Right to be heard (ultra petita) in appeal proceedings
- Suspensive effect of revocation appeal (Art. 74(2) UPCA)
- 2025-11-25Appeal RoP220.1Public
Summary: The Court of Appeal allowed Amgen's appeals in the revocation action and counterclaim for revocation concerning the PCSK9 antibody patent (Amgen v Sanofi and Regeneron). It set aside the Munich Central Division's decision revoking the patent, rejected the requests to revoke the patent in the UPC territories, and ordered Sanofi and Regeneron to bear the costs of both instances (EUR 1,375,000 each for first instance). The patent is maintained; the Court of Appeal found the claimed invention involved an inventive step.
Show the legal issues (5)
- Claim interpretation (medical use-format claims)
- Added matter
- Sufficiency of disclosure
- Inventive step (PCSK9 antibodies)
- Reasonable expectation of success
| Document title | Date | Public |
|---|---|---|
| Decision | 2026-03-25 | Not public |
| Decision | 2026-03-25 | Public |
| Receipt | 2026-03-13 | Not public |
| Cover sheet | 2026-03-13 | Not public |
| Application Appellant | 2026-03-13 | Not public |
| Receipt | 2026-03-11 | Not public |
| Cover sheet | 2026-03-11 | Not public |
| Application Respondent | 2026-03-11 | Not public |
| Receipt | 2026-02-25 | Not public |
| Cover sheet | 2026-02-25 | Not public |
| Application Appellant | 2026-02-25 | Not public |
| Order | 2026-02-18 | Not public |
| Order | 2026-02-18 | Public |
| Receipt | 2026-02-05 | Not public |
| Cover sheet | 2026-02-05 | Not public |
| Application document Appellant | 2026-02-05 | Not public |
| Order | 2026-01-29 | Not public |
| Order | 2026-01-29 | Public |
| Receipt | 2026-01-26 | Not public |
| Cover sheet | 2026-01-26 | Not public |
| Other document Respondent | 2026-01-26 | Not public |
| Exhibit document Respondent | 2026-01-26 | Not public |
| Exhibit document Respondent | 2026-01-26 | Not public |
| Exhibit document Respondent | 2026-01-26 | Not public |
| Exhibit document Respondent | 2026-01-26 | Not public |
| Exhibit document Respondent | 2026-01-26 | Not public |
| Application document Respondent | 2026-01-26 | Not public |
| Receipt | 2026-01-26 | Not public |
| Cover sheet | 2026-01-26 | Not public |
| Application document Respondent | 2026-01-26 | Not public |
| Communication | 2025-12-12 | Not public |
| Cover sheet | 2025-12-10 | Not public |
| Application document Respondent | 2025-12-10 | Not public |
| Receipt | 2025-12-10 | Not public |
| Case closed | 2025-11-25 | Not public |
| Decision | 2025-11-25 | Not public |
| Decision | 2025-11-25 | Public |
| Communication | 2025-11-24 | Not public |
| Oral procedure closed | 2025-09-22 | Not public |
| Oral procedure opened | 2025-09-22 | Not public |
| Written procedure closed | 2025-09-22 | Not public |
| Hearing Reference | 2025-08-13 | Not public |
| Hearing Reference | 2025-08-13 | Not public |
| Schedule for oral hearing | 2025-08-05 | Public |
| Receipt | 2025-06-26 | Not public |
| Receipt | 2025-06-26 | Not public |
| C128 | 2025-06-25 | Not public |
| C130 | 2025-06-25 | Not public |
| C123 | 2025-06-25 | Not public |
| C128 | 2025-06-25 | Not public |
| C124 | 2025-06-25 | Not public |
| C118 | 2025-06-25 | Not public |
| C125 | 2025-06-25 | Not public |
| 2025.06.25 EP797 UPC appeal - letter to CoA commenting on OD decision | 2025-06-25 | Not public |
| C126 | 2025-06-25 | Not public |
| C127 | 2025-06-25 | Not public |
| C118 | 2025-06-25 | Not public |
| C132 | 2025-06-25 | Not public |
| C129 | 2025-06-25 | Not public |
| C131 | 2025-06-25 | Not public |
| C133 | 2025-06-25 | Not public |
| Comments on the decision of the OD in opposition | 2025-06-25 | Not public |
| D102 - Decision Opposition Division of 21 May 2025 and minutes of the oral proceedings held on 31 March - 3 April 2025 | 2025-06-25 | Not public |
| Outcome of the Order | 2025-05-26 | Not public |
| order on time extension | 2025-05-26 | Public |
| Receipt | 2025-05-22 | Not public |
| 2025.05.22 - Request for extension deadline for providing comments on OD decision - signed | 2025-05-22 | Not public |
| Summons | 2025-05-06 | Public |
| Response to order dated 17 April | 2025-04-29 | Not public |
| Annex - Evidence of prior commitment | 2025-04-29 | Not public |
| Reply to CoA Order | 2025-04-29 | Not public |
| case management order | 2025-04-17 | Public |
| Interim-Procedure-Closure | 2025-03-18 | Not public |
| Summon-Oral-Hearing | 2025-03-18 | Not public |
| order on IC | 2025-03-18 | Public |
| Template-Order | 2025-03-18 | Not public |
| Interim-Conference-Decision | 2025-03-18 | Not public |
| Acknowledgement-of-lodging | 2025-02-17 | Not public |
| C116a | 2025-02-17 | Not public |
| C121a | 2025-02-17 | Not public |
| C118a | 2025-02-17 | Not public |
| C117a | 2025-02-17 | Not public |
| C117 | 2025-02-17 | Not public |
| C120 | 2025-02-17 | Not public |
| C121 | 2025-02-17 | Not public |
| 2025.02.17 Statement of Response - signed | 2025-02-17 | Not public |
| C119 | 2025-02-17 | Not public |
| C122 | 2025-02-17 | Not public |
| C116 | 2025-02-17 | Not public |
| C120a | 2025-02-17 | Not public |
| C115a | 2025-02-17 | Not public |
| C119a | 2025-02-17 | Not public |
| C122a | 2025-02-17 | Not public |
| C115 | 2025-02-17 | Not public |
| C118 | 2025-02-17 | Not public |
| Summons to oral hearing | 2025-02-11 | Public |
| 2025.02.05 - Submission on appeal hearing date (Sanofi _ RGN) | 2025-02-05 | Not public |
| Flight reservation | 2025-02-05 | Not public |
| Reply Summons CoA | 2025-02-05 | Not public |
| Summons | 2025-01-30 | Not public |
| Comments | 2025-01-27 | Not public |
| Summonts TBA hearing | 2025-01-24 | Not public |
| Request rescheduling hearing | 2025-01-24 | Not public |
| Summons | 2025-01-22 | Not public |
| Panel-Appointment | 2024-12-11 | Not public |
| Acknowledgement-of-lodging | 2024-11-28 | Not public |
| Acknowledgement-of-lodging | 2024-11-15 | Not public |
| Statement of Grounds of Appeal | 2024-11-15 | Not public |
| D101 | 2024-11-15 | Not public |
| Annex 3 - Consolidated list | 2024-11-15 | Not public |
| D100 | 2024-11-15 | Not public |
| Panel-Appointment | 2024-10-07 | Not public |
| Receipt | 2024-10-07 | Not public |
| Acknowledgement-of-lodging | 2024-10-07 | Not public |
| Formal-checks_Notification-of-positive-outcome | 2024-10-07 | Not public |
| Acknowledgement-of-lodging | 2024-10-04 | Not public |
| Request_RgR16_1(b)_Change_details_representative_signed | 2024-10-04 | Not public |
| Rectified Statement of Appeal | 2024-10-02 | Not public |
| Statement of Appeal | 2024-10-02 | Not public |
| Proof of payment | 2024-10-02 | Not public |
| Formal-checks_Request-for-correction | 2024-09-24 | Not public |
| Acknowledgement-of-lodging | 2024-09-13 | Not public |
| Proof of payment | 2024-09-13 | Not public |
| Statement of Appeal | 2024-09-13 | Not public |