Amgen v Sanofi-Aventis Deutschland (CFI, 2 February 2024)
| Date | 2 February 2024 |
|---|---|
| Court | CFI |
| Division | Munich (DE) Local Division |
| Type of action | Infringement Action |
| Case number(s) | UPC_CFI_14/2023 |
| Registry reference | ACT_459916/2023 · ORD_392/2024 · UPC_CFI_14/2023 |
| Parties | Amgen Inc. v. Sanofi-Aventis Deutschland GmbH, Sanofi-Aventis Groupe S.A., Sanofi Winthrop Industrie S.A., Regeneron Pharmaceuticals Inc. |
Official decision (PDF) · UPC registry entry
Case timeline
- 17 July 2023 : Amgen v Sanofi-Aventis Deutschland (CFI, 17 July 2023) ORD_551192/2023 · UPC_CFI_14/2023
- 28 July 2023 : Amgen v Sanofi-Aventis Deutschland (CFI, 28 July 2023) ORD_556750/2023 · UPC_CFI_14/2023
- 16 August 2023 : Amgen v Sanofi-Aventis Deutschland (CFI, 16 August 2023) ORD_562104/2023 · UPC_CFI_14/2023
- 17 August 2023 : Amgen v Sanofi-Aventis Deutschland (CFI, 17 August 2023) ORD562104/2023 · UPC_CFI_14/2023
- 17 August 2023 : Sanofi-Aventis Deutschland v Amgen (CFI, 17 August 2023) ORD_562104/2023 · UPC_CFI_14/2023
- 29 August 2023 : Amgen v Sanofi-Aventis Deutschland (CFI, 29 August 2023) ORD_566193/2023 · UPC_CFI_14/2023
- 3 November 2023 : Amgen v Sanofi-Aventis Deutschland (CFI, 3 November 2023) ORD_584907/2023 · UPC_CFI14/2023
- 2 January 2024 : Amgen v Sanofi-Aventis Deutschland (CFI, UPC_CFI_14/2023, ORD_597730/2023, 2 January 2024) ORD_597730/2023 · UPC_CFI14/2023
- 2 January 2024 : Amgen v Sanofi-Aventis Deutschland (CFI, UPC_CFI_14/2023, ORD_597730/2023, 2 January 2024, doc. 2) ACT_459916/2023 · ORD_597730/2023 · UPC_CFI_14/2023
- 2 January 2024 : Amgen v Sanofi-Aventis Deutschland (CFI, UPC_CFI_14/2023, ORD_597730/2023, 2 January 2024, doc. 3) ACT_459916/2023 · ORD_597730/2023 · UPC_CFI_14/2023
- 24 February 2024 : Sanofi v Amgen (CFI, 24 February 2024) ACT_459505/2023andCC_586764/2023 · ORD_10396/2024 · ORD_10398/2024 · UPC_CFI_1/2023 · UPC_CFI_14/2023
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 2 February 2024 (UPC_CFI_14/2023, ORD_392/2024), the Munich Local Division referred Regeneron’s counterclaim for revocation of Amgen’s EP 3 666 797 to the Central Division and proceeded with the infringement action concerning alirocumab (Praluent), while reserving the possibility of a later stay. The order shows how a local division exercises its options under Art. 33(3) UPCA where the validity of the same patent is already being litigated before the Central Division.
Question
The Sanofi defendants had brought a stand-alone revocation action before the Central Division (UPC_CFI_1/2023), with an oral hearing set for 4 June 2024, Regeneron had filed a counterclaim before the local division. All parties asked for the counterclaim to be referred. They disagreed on the infringement action, the defendants seeking a stay. The division had to choose between the options under Art. 33(3) UPCA and Rule 37 RoP.
Decision
A request on which all parties agree is granted absent strong reasons to the contrary, and there were none: referral avoids inconsistent decisions and duplicated work on validity, even though hearing infringement and revocation before the same panel usually has advantages (II.1 and II.2). The infringement action proceeds (Art. 33(3)(b)). A stay remains possible under Art. 33(3)(c) and Rule 37.4, but the division need not assess the likelihood of invalidity now, since a first instance decision on validity is expected before the summer (III.1 and III.2). The division noted that Sanofi could have filed a counterclaim under Rule 75 with its statement of defence (III.5). The other grounds for a stay were left open (IV).
Key points for practice
- Where all parties agree that a counterclaim should be referred to the Central Division, the local division will in principle follow.
- Referral does not entail an automatic stay: the division may proceed on infringement and revisit a stay once the validity decision draws near.
Provisions applied
- Agreement on a Unified Patent Court
- Art. 33(3)
- Rules of Procedure
- Rules 37, 75.3 and 264
- Case law cited
- None.
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: Patent infringement action.
Publications by Matthieu Dhenne: Pleading the Long Arm: What a UPC Statement of Claim Must Carry Beyond Jurisdiction (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
- defendantSanofi-Aventis Deutschland GmbH28 decisions in the corpusFollow this party
- defendantSanofi-Aventis Groupe S.A.8 decisions in the corpusFollow this party
- defendantRegeneron Pharmaceuticals Inc.12 decisions in the corpusFollow this party
- claimantAmgen Inc.24 decisions in the corpusFollow this party
- defendantSanofi Winthrop Industrie S.A.7 decisions in the corpusFollow this party
Decisions in the same proceedings and documented appeals
- 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.
- 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.
- 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.
- 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.
- 17 August 2023 Sanofi-Aventis Deutschland v Amgen (CFI, 17 August 2023) Generic Order · UPC_CFI_14/2023
- 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.
- 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.
- 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.
- 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
- 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
- 2 February 2024 Amgen v Sanofi-Aventis Deutschland (CFI, 2 February 2024) Infringement Action · UPC_CFI_14/2023
- 24 February 2024 Sanofi v Amgen (CFI, 24 February 2024) Revocation Action · UPC_CFI_14/2023
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.
What the record states
- Nature of the act
- Infringement Action
- Outcome (Dhenne Avocats summary)
- 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.
- 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 3 666 797mentioned in: Dhenne Avocats analysis Follow this patent
Related decisions cited in the analyses
- Sanofi v Amgen (CFI, 24 February 2024) cited in this record
- Amgen v Sanofi-Aventis Deutschland (CFI, UPC_CFI_14/2023, ORD_597730/2023, 2 January 2024) cited in this record
- Amgen v Sanofi-Aventis Deutschland (CFI, UPC_CFI_14/2023, ORD_597730/2023, 2 January 2024, doc. 2) cited in this record
- Amgen v Sanofi-Aventis Deutschland (CFI, UPC_CFI_14/2023, ORD_597730/2023, 2 January 2024, doc. 3) cited in this record
- Amgen v Sanofi-Aventis Deutschland (CFI, 3 November 2023) cited in this record
- Amgen v Sanofi-Aventis Deutschland (CFI, 29 August 2023) cited in this record
- Amgen v Sanofi-Aventis Deutschland (CFI, 17 August 2023) cited in this record
- Sanofi-Aventis Deutschland v Amgen (CFI, 17 August 2023) cited in this record
- Amgen v Sanofi-Aventis Deutschland (CFI, 16 August 2023) cited in this record
- Amgen v Sanofi-Aventis Deutschland (CFI, 28 July 2023) cited in this record
- Amgen v Sanofi-Aventis Deutschland (CFI, 17 July 2023) cited in this record
- Labrador Diagnostics v bioMérieux (CFI, 23 April 2025) cites this decision
- GlaxoSmithKline Biologicals v Pfizer Europe MA EEIG (CFI, 4 March 2025) cites this decision
- Daedalus Prime v Xiaomi Communications (CFI, 16 January 2025) cites this decision
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) · 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 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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