SANOFI-AVENTIS DEUTSCHLAND v AMGEN (CoA, 18 February 2026)
| Date | 18 February 2026 |
|---|---|
| Court | CoA |
| Division | Luxembourg (LU) |
| Type of action | Generic application |
| Case number(s) | UPC_CoA_528/2024;UPC_CoA_529/2024 |
| Registry reference | UPC_CoA_528/2024 · UPC_CoA_529/2024 |
| Parties | SANOFI-AVENTIS DEUTSCHLAND GMBH, SANOFI-AVENTIS GROUPE S.A., SANOFI WINTHROP INDUSTRIE S.A., and Regeneron Pharmaceuticals Inc. v. AMGEN, INC |
Official decision (PDF) · UPC registry entry
Case timeline
- 25 November 2025 : Amgen v Sanofi-Aventis Deutschland (CoA, 25 November 2025) UPC_CoA_528/2024
- 25 March 2026 : SANOFI-AVENTIS DEUTSCHLAND v AMGEN (CoA, 25 March 2026) UPC_CoA_528/2024 · UPC_CoA_529/2024
Dhenne Avocats represents claimants and defendants in European patent disputes before the Unified Patent Court, including the Paris divisions.
Dhenne Avocats · 10 October 2026
Our analysis
Summary
By order of 18 February 2026 in the joined proceedings UPC_CoA_528/2024 and UPC_CoA_529/2024 (EP 3 666 797), the Court of Appeal rejected Sanofi and Regeneron’s request for suspensive effect of their application for rehearing of the decision of 25 November 2025, which had set aside the Munich Central Division’s revocation of Amgen’s patent of 16 July 2024. The order confirms that a rehearing application does not, as a rule, suspend the decision under challenge, and that it cannot be used to extend the stay of the infringement action.
Question
On what conditions may an application for rehearing be given suspensive effect, and is there anything to suspend where the decision under challenge rejects the revocation request?
Decision
Rehearing is granted only exceptionally (Article 81(1)(b) UPCA, Rule 247(c)) and, under Rule 252, the application has no suspensive effect unless the Court decides otherwise (paragraphs 13 and 14). By analogy with Article 74(1) UPCA, the applicant must show particular circumstances, such as a manifest fundamental procedural defect (paragraph 15). Sanofi and Regeneron offered no argument to that effect and did not claim that the alleged defects were manifest, which sufficed for dismissal (paragraph 16). Moreover, since the appeal against revocation had suspensive effect (Article 74(2)), the patent remained in force, and the decision rejecting revocation changed nothing in its status: there was nothing to suspend (paragraphs 17 and 18). A further stay of the infringement action cannot be obtained by this route (paragraph 19).
Key points for practice
- A request for suspensive effect of a rehearing application must be reasoned in its own right and point to a manifest defect. It has no object against a decision that upholds the patent (paragraphs 15 to 18).
Provisions applied
- Agreement on a Unified Patent Court
- Arts 74(1), 74(2), 76 and 81(1)(b)
- Rules of Procedure
- Rules 247 and 252
Related decisions
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.
Decisions in the same proceedings
Going further
Lexicon: UPC Court of Appeal, Supplementary protection certificate (SPC), Biosimilar medicinal product, Launch at risk.
Dhenne Avocats blog: UPC Appeals: What the Numbers Show, Pharmaceutical patents and the UPC: is the Court hostile to them?.
Publications by Matthieu Dhenne: The Launch Letter: How Generics and Biosimilars Should Write to Avoid UPC Urgency (Kluwer Patent Blog).
Source and translations
- Official source
- Unified Patent Court registry link recorded in the record
- Original language
- not recorded
- Translation available
- no translation recorded the firm’s French record is a summary, not a translation
- Date checked
- not recorded
Follow this case
Proceedings, related decisions, appeals, parties and patents as recorded in the registry and in the Dhenne Avocats corpus. Each link states its source.
Parties
- defendantINC5 decisions in the corpusFollow this party
- claimantSANOFI-AVENTIS DEUTSCHLAND GMBH28 decisions in the corpusFollow this party
- claimantSANOFI-AVENTIS GROUPE S.A.8 decisions in the corpusFollow this party
- claimantSANOFI WINTHROP INDUSTRIE S.A., and Regeneron Pharmaceuticals Inc.2 decisions in the corpusFollow this party
- defendantAMGEN3 decisions in the corpusFollow this party
Decisions in the same proceedings and documented appeals
- 25 November 2025 Amgen v Regeneron Pharmaceuticals (CoA, 25 November 2025) Appeal RoP220.1 · UPC_CoA_529/2024
- 25 November 2025 Amgen v Sanofi-Aventis Deutschland (CoA, 25 November 2025) Appeal RoP220.1 · UPC_CoA_528/2024
La cour d’appel infirme l’annulation de l’EP 3 666 797 d’Amgen, juge le brevet suffisamment décrit, sans extension et inventif faute d’attente raisonnable de succès à la date de priorité, et condamne Sanofi et Regeneron aux frais des deux instances.
- 18 February 2026 SANOFI-AVENTIS DEUTSCHLAND v AMGEN (CoA, 18 February 2026) Generic application · UPC_CoA_528/2024, UPC_CoA_529/2024
- 25 March 2026 SANOFI-AVENTIS DEUTSCHLAND v AMGEN (CoA, 25 March 2026) Withdrawal (RoP265) · UPC_CoA_528/2024, UPC_CoA_529/2024
La cour d’appel autorise le retrait des requêtes en révision de Sanofi et Regeneron, déclare la procédure close et refuse le remboursement des frais de justice, une seule taxe ayant été payée pour deux requêtes.
What the record states
- Nature of the act
- Generic application
- Outcome (Dhenne Avocats summary)
- La demande d'effet suspensif est rejetée : elle n'était pas motivée et l'arrêt attaqué, qui rejette la demande en nullité, ne modifie pas la situation du brevet et n'a rien à suspendre.
- Appeal
- Decision of the Court of Appeal.
- Instance
- Court of Appeal decision.
Patents mentioned
EP 3 666 797mentioned in: Dhenne Avocats analysis Follow this patent
Related decisions cited in the analyses
- SANOFI-AVENTIS DEUTSCHLAND v AMGEN (CoA, 25 March 2026) cited in this record
- Amgen v Regeneron Pharmaceuticals (CoA, 25 November 2025) cited in this record
- Amgen v Sanofi-Aventis Deutschland (CoA, 25 November 2025) cited in this record
Patents and standards
| Publication | Role in the dispute | Family | Standard and declaration | Pool | Sources |
|---|---|---|---|---|---|
EP 3 666 797Antigen binding proteins to proprotein convertase subtilisin kexin type 9 (PCSK9) recorded proprietor: Amgen Inc | Mentioned in the analysis (role not qualified) Also mentioned in 21 other decision(s): Amgen v Sanofi-Aventis Deutschland (CoA, 25 November 2025) · Sanofi-Aventis Deutschland v Amgen (CFI, 16 July 2024) · Regeneron Pharmaceuticals v Amgen (CFI, 16 July 2024) · SANOFI-AVENTIS DEUTSCHLAND v AMGEN (CoA, 25 March 2026) · Dehns v Regeneron Pharmaceuticals (CFI, 22 October 2024) · Sanofi-Aventis Deutschland v Amgen (CFI, ORD_47230/2024, 22 October 20 · Sanofi-Aventis Deutschland v Amgen (CFI, ORD_47238/2024, 22 October 20 · Amgen v Sanofi Winthrop Industrie (CFI, 29 July 2024) | not recorded | not recorded | not recorded | Espacenet · European Patent Register existence and title of the publication checked on 30 October 2026 (Google Patents, Espacenet and Register links are not checked automatically) mentioned in: Dhenne Avocats analysis |
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