Sanofi Biotechnologies v Amgen (CFI, 6 August 2025)

Date	6 August 2025
Court	CFI
Division	Düsseldorf (DE) Local Division
Type of action	Generic application
Registry reference	App_27318/2025 · ORD_27388/2025
Parties	Sanofi Biotechnology SAS, Regeneron Pharmaceuticals Inc.

Official decision (PDF) · UPC registry entry

Dhenne Avocats represents claimants and defendants in European patent disputes before the Unified Patent Court, including the Paris divisions.

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Dhenne Avocats · 10 October 2026

Our analysis

Summary

By order of 6 August 2025 (UPC_CFI_195/2025, ACT_10334/2025 and CC_29742/2025), the Düsseldorf Local Division (Presiding Judge Thomas, Judges Thom and Kupecz, and technically qualified Judge Dorland-Galliot) stayed, at the request of the claimants Sanofi Biotechnologies and Regeneron, the infringement action on EP 4 252 857 against several Amgen companies and the counterclaim for revocation, pending the outcome of the appeal against decision ORD_598583/2023 given by the same division in UPC_CFI_505/2024 on EP 3 536 712. The order shows how a stay may be used where two patents of the same family raise the same issues.

Question

Should an infringement action be stayed pending the appeal of a decision on a related patent where the factual and legal questions are the same?

Decision

The division finds that infringement of EP 4 252 857 raises the same questions as UPC_CFI_505/2024. A stay serves the proper administration of justice: if the appeal reveals no significant difference, the claim would probably be dismissed as well, and the claimants could then withdraw it, if the appeal succeeds, they may advance new arguments and the defendants keep the first instance to explain why the case differs. Neither party will thus have spent more time or money than necessary. The division sees no conflict with the right to an effective remedy and a hearing within a reasonable time (Art. 6 ECHR), as no injunction has been granted. For efficiency, the stay extends to the counterclaim.

Key points for practice

Practical point: a patentee whose case on a patent of the same family is on appeal may obtain a stay of its second action rather than run both in parallel.

Provisions applied

Agreement on a Unified Patent Court: Arts 41(3) and 42
Rules of Procedure: Rule 295(m)
Case law cited: Düsseldorf Local Division, ORD_598583/2023 (UPC_CFI_505/2024, ACT_597355/2023), date not stated in the order.

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.

Going further

Lexicon: Supplementary protection certificate (SPC), Biosimilar medicinal product, Launch at risk.

Dhenne Avocats blog: 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

Only the official text is authoritative. A machine translation is never presented as official, republishing a third-party document requires a verified basis in rights, and a link to the source is preferred.

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.

Proceedings

No case number recorded in this record.

Parties

claimantSanofi Biotechnology SAS2 decisions in the corpus Follow this party
claimantRegeneron Pharmaceuticals Inc.12 decisions in the corpus Follow this party

Exact name as it appears in the record, group affiliation only where sourced and dated.

Decisions in the same proceedings and documented appeals

No other decision in the corpus bears the same case number, and no appeal is documented in the corpus to date.

What the record states

Nature of the act: Generic application
Outcome (Dhenne Avocats summary): L'action en contrefaçon et la demande reconventionnelle en nullité sont suspendues jusqu'à l'issue de l'appel d'une décision rendue sur un brevet apparenté soulevant les mêmes questions.
Appeal: No appeal documented in the corpus, this does not mean that no appeal was lodged.
Instance: First-instance decision, whether it has become final is not recorded.

Patents mentioned

EP 4 252 857 mentioned in: Dhenne Avocats analysis Follow this patent
EP 3 536 712 mentioned in: Dhenne Avocats analysis Follow this patent

Scope: Dhenne Avocats corpus. Registry-based links are marked “official number”; links derived from the analyses are marked as such. An erroneous link can be withdrawn without deleting any record.

Patents and standards

Publication	Role in the dispute	Family	Standard and declaration	Pool	Sources
`EP 4 252 857`	Mentioned in the analysis (role not qualified) Also mentioned in 1 other decision(s): Sanofi Biotechnologies v Amgen (CFI, 8 June 2026)	not recorded	not recorded	not recorded	Espacenet links not checked mentioned in: Dhenne Avocats analysis
`EP 3 536 712`	Mentioned in the analysis (role not qualified) Also mentioned in 3 other decision(s): Sanofi Biotechnology v Amgen (CFI, 13 May 2025) · Sanofi Biotechnology v Amgen (CoA, 24 March 2026) · Amgen v Sanofi Biotechnology (CoA, 24 March 2026)	not recorded	not recorded	not recorded	Espacenet links not checked mentioned in: Dhenne Avocats analysis

The statuses “asserted in litigation”, “declared essential”, “listed by a pool” and “essentiality examined by a court” are distinct and may coexist. Validity, infringement and technical essentiality are different questions. Scope: patents cited in the decisions of the Dhenne Avocats corpus, with no essentiality score or prediction.

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