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Sanofi v Amgen (CFI, 24 February 2024)

Date24 February 2024
CourtCFI
DivisionMunich (DE) Central Division - Section
Type of actionRevocation Action
Case number(s)UPC_CFI_1/2023;UPC_CFI_14/2023
Registry referenceACT_459505/2023andCC_586764/2023 · ORD_10396/2024 · ORD_10398/2024 · UPC_CFI_1/2023 · UPC_CFI_14/2023
PartiesSanofi v. Amgen, Regeneron

Official decision (PDF) · UPC registry entry

Case timeline

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

Contact the firm

Dhenne Avocats · 10 October 2026

Our analysis

Summary

By order of 27 February 2024 (ORD_10396/2024 and ORD_10398/2024), the judge-rapporteur of the Munich Central Division decided, with the agreement of all parties, to deal jointly with Sanofi’s revocation action against Amgen’s EP 3 666 797 (UPC_CFI_1/2023, ACT_459505/2023) and Regeneron’s counterclaim for revocation referred by the Munich Local Division (UPC_CFI_14/2023, CC_586764/2023). The order organises the end of the written and interim stage for a joint hearing on 4 June 2024 and sets the value of each action at EUR 100 million for the ceiling of recoverable costs. It shows how a revocation action and a counterclaim for revocation against the same patent are managed together.

Question

On what conditions, and on what terms, may an advanced revocation action and a counterclaim for revocation referred to the Central Division be dealt with jointly?

Decision

Joint handling was granted on condition that the parties align their grounds, arguments, facts and evidence, the revocation action being considerably further advanced than the counterclaim. All submissions, exhibits and defences are deemed filed in both cases, while costs may be dealt with separately. Regeneron may file a succinct reply by 7 March 2024 and Amgen a rejoinder by 21 March 2024, with no new expert evidence or exhibits. The claimants may use slides, but not models, and case summaries of no more than 7,500 words are allowed, without new arguments. Documents D99 and C10a were admitted, an interim conference was held unnecessary and the parties’ experts will not be heard. The agreed value of EUR 100 million for each action corresponds to a ceiling of EUR 2 million.

Key points for practice

Provisions applied

Agreement on a Unified Patent Court
Art. 69
Rules of Procedure
Rules 9, 28, 103, 104, 108 and 333

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: Revocation action.

Publications by Matthieu Dhenne: G 1/25, Take Three: Anything You Leave in the Description May Be Used Against You (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

  • UPC_CFI_1/2023 official number
  • UPC_CFI_14/2023 official number

Follow these proceedings

Parties

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

Decisions in the same proceedings and documented appeals

  1. 29 June 2023 Sanofi-Aventis Deutschland v Amgen (CFI, 29 June 2023) Revocation Action · UPC_CFI_1/2023

    Les documents déposés par les sociétés Sanofi sont admis comme pièces de la demande en nullité, réputée signifiée à Amgen le 29 juin 2023.

  2. 17 July 2023 Amgen v Sanofi-Aventis Deutschland (CFI, 17 July 2023) Infringement Action · UPC_CFI_14/2023

    Le juge rapporteur disjoint la procédure contre Regeneron, non encore signifiée, pour ne pas retarder l'instance contre les sociétés Sanofi, et partage par moitié les frais de justice.

  3. 28 July 2023 Amgen v Sanofi-Aventis Deutschland (CFI, 28 July 2023) Infringement Action · UPC_CFI_14/2023

    La procédure contre Regeneron n'est pas disjointe, Amgen ayant retiré sa demande après la signification. L'ordonnance provisoire du 17 juillet 2023 devient sans objet.

  4. 16 August 2023 Amgen v Sanofi-Aventis Deutschland (CFI, 16 August 2023) Infringement Action · UPC_CFI_14/2023

    Le juge rapporteur dispense exceptionnellement les parties de réitérer les demandes déposées dans de mauvais circuits, fixe au 21 août 2023 le terme des observations et réserve un circuit unique aux délais et à l'audition conjointe.

  5. 17 August 2023 Amgen v Sanofi-Aventis Deutschland (CFI, 17 August 2023) Infringement Action · UPC_CFI_14/2023

    Le juge rapporteur dispense exceptionnellement les parties de réitérer les demandes déposées dans de mauvais circuits, réserve un circuit unique aux questions de délais et fixe au 22 août 2023 le terme des observations.

  6. 17 August 2023 Sanofi-Aventis Deutschland v Amgen (CFI, 17 August 2023) Generic Order · UPC_CFI_14/2023
  7. 24 August 2023 Amgen v Sanofi-Aventis Deutschland (CFI, 24 August 2023) Preliminary objection · UPC_CFI_1/2023

    L'action en nullité déposée au greffe de Luxembourg à 11 h 26 précède l'action en contrefaçon déposée à 11 h 45, la division centrale est compétente et l'exception préliminaire est rejetée.

  8. 29 August 2023 Amgen v Sanofi-Aventis Deutschland (CFI, 29 August 2023) Infringement Action · UPC_CFI_14/2023

    La division locale juge le mémoire en demande complet et valablement signifié malgré le téléversement ultérieur des pièces annoncées, refuse en principe toute prorogation, mais aligne à titre exceptionnel le délai de défense de tous les défendeurs au 17 octobre 2023.

  9. 20 September 2023 Sanofi-Aventis Deutschland v Amgen (CFI, 20 September 2023) Revocation Action · UPC_CFI_1/2023

    Le juge rapporteur rejette la demande d'accès aux écritures et pièces d'un mandataire souhaitant se forger une opinion sur la validité du brevet, faute de motif concret et vérifiable, et autorise l'appel.

  10. 3 November 2023 Amgen v Sanofi-Aventis Deutschland (CFI, 3 November 2023) Infringement Action · UPC_CFI_14/2023

    La langue de procédure passe de l'allemand à l'anglais, langue de délivrance du brevet, toutes les parties et la formation y consentant. Amgen traduit son mémoire introductif sous deux mois.

  11. 2 January 2024 Amgen v Sanofi-Aventis Deutschland (CFI, UPC_CFI_14/2023, ORD_597730/2023, 2 January 2024) Infringement Action · UPC_CFI_14/2023

    Le juge rapporteur proroge au 8 janvier 2024 le délai accordé aux défenderesses pour commenter les dates provisoires de la conférence intermédiaire et de l'audience.

  12. 2 January 2024 Amgen v Sanofi-Aventis Deutschland (CFI, UPC_CFI_14/2023, ORD_597730/2023, 2 January 2024, doc. 2) Infringement Action · UPC_CFI_14/2023
  13. 2 January 2024 Amgen v Sanofi-Aventis Deutschland (CFI, UPC_CFI_14/2023, ORD_597730/2023, 2 January 2024, doc. 3) Infringement Action · UPC_CFI_14/2023
  14. 24 January 2024 Sanofi-Aventis Deutschland v Amgen (CFI, 24 January 2024) Revocation Action · UPC_CFI_1/2023

    Le juge rapporteur admet la lettre des demanderesses et ses déclarations d'experts répondant à des points nouveaux de la duplique, et rejette les demandes d'Amgen tendant à la clôture immédiate ou à une réplique supplémentaire.

  15. 2 February 2024 Amgen v Sanofi-Aventis Deutschland (CFI, 2 February 2024) Infringement Action · UPC_CFI_14/2023

    La division locale de Munich renvoie la demande reconventionnelle en nullité de Regeneron à la division centrale et poursuit l'action en contrefaçon d'Amgen, en se réservant de la suspendre ultérieurement.

  16. 24 February 2024 Sanofi v Amgen (CFI, 24 February 2024) Revocation Action · UPC_CFI_1/2023, UPC_CFI_14/2023

What the record states

Nature of the act
Revocation Action
Outcome (Dhenne Avocats summary)
L'action en nullité de Sanofi et la demande reconventionnelle en nullité de Regeneron contre le brevet d'Amgen sont instruites conjointement en vue d'une audience le 4 juin 2024, la valeur de chaque action étant fixée à 100 millions d'euros.
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

Related decisions cited in the analyses

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

PublicationRole in the disputeFamilyStandard and declarationPoolSources
EP 3 666 797
Antigen 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) · SANOFI-AVENTIS DEUTSCHLAND v AMGEN (CoA, 18 February 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		not recordednot recordednot recordedEspacenet · 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
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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