Sanofi v Accord Healthcare (CFI, 8 May 2025)
| Date | 8 May 2025 |
|---|---|
| Court | CFI |
| Division | Munich (DE) Local Division |
| Type of action | Generic Order |
| Registry reference | ORD_10064/2025 |
| Parties | Sanofi B.V., Sanofi A/S, Sanofi Belgium, Sanofi-Aventis GmbH, Sanofi - Produtos Farmaceuticos Lda, Sanofi-Aventis Deutschland GmbH, Sanofi … |
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.
Dhenne Avocats · 10 October 2026
Our analysis
Summary
By order of 8 May 2025, the judge rapporteur of the Munich Local Division, dealing with Sanofi’s four joined actions against Accord, STADA, Reddy and Zentiva under EP 2 493 466 (UPC_CFI_145/2024 to UPC_CFI_148/2024, with the counterclaims for revocation), deferred the preliminary objections to the main proceedings and referred the remaining pending requests to the panel for decision after the oral hearing, and set the timetable. His observations on Rule 263 and on poorly drafted requests are of practical interest.
Question
Should the preliminary objections, repeatedly amended requests and requests for information be decided at the interim stage?
Decision
Using his powers under Rule 332, the judge rapporteur preferred to await the decision of the EPO Board of Appeal (hearing on 2 to 4 June 2025), the French designation having been invalidated at first instance in France. As Sanofi had still not, despite several invitations, filed unambiguous requests, no further opportunity to cure will be given: the panel will interpret the claims, which alone bind it (Art. 76(1) UPCA), and the extra cost caused may weigh in the costs decision (Art. 69(3) UPCA). Adding auxiliary requests for indirect infringement and a request for an interim award of damages does not appear to fall under Rule 263, since the patent and product remain the same. An order to produce sales figures would be premature. The rejoinder is due within two months, the written procedure closes on 8 August 2025 and the oral hearing remains set for 14 to 17 October 2025.
Key points for practice
- In the judge rapporteur’s view, relying on indirect infringement in the alternative is not an amendment of the case under Rule 263 as long as the patent and the product remain the same.
- Ambiguous requests do not lead to dismissal on formal grounds, but the ambiguity may count against the claimant when costs are apportioned.
Provisions applied
- Agreement on a Unified Patent Court
- Arts 34, 47, 69(3) and 76(1)
- Rules of Procedure
- Rules 9, 13, 20.2, 29, 118, 119, 125, 263, 265, 332 and 333
- Case law cited
- Court of Appeal, UPC_CoA_456/2024 and UPC_CoA_169/2025, Munich Local Division, 22 September 2024 (UPC_CFI_114/2024)
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
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
Parties
- claimantSanofi-Aventis Deutschland GmbH28 decisions in the corpusFollow this party
- claimantSanofi A/S7 decisions in the corpusFollow this party
- claimantSanofi-Aventis GmbH9 decisions in the corpusFollow this party
- claimantSanofi B.V.12 decisions in the corpusFollow this party
- claimantSanofi13 decisions in the corpusFollow this party
- claimantProdutos Farmaceuticos Lda8 decisions in the corpusFollow this party
- claimantSanofi Belgium8 decisions in the corpusFollow this party
Decisions in the same proceedings and documented appeals
What the record states
- Nature of the act
- Generic Order
- Outcome (Dhenne Avocats summary)
- Le juge rapporteur renvoie les exceptions préliminaires au fond et les demandes pendantes à la formation après l'audience, refuse toute nouvelle régularisation des demandes de Sanofi et fixe le calendrier jusqu'à l'audience d'octobre 2025.
- 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 2 493 466mentioned in: Dhenne Avocats analysis Follow this patent
Related decisions cited in the analyses
- Sanofi (CFI, 8 May 2025) cites this decision
- Sanofi Mature IP (CFI, 8 May 2025) cites this decision
- STADA Nordic (CFI, 8 May 2025) cites this decision
Patents and standards
| Publication | Role in the dispute | Family | Standard and declaration | Pool | Sources |
|---|---|---|---|---|---|
EP 2 493 466Novel antitumoral use of cabazitaxel recorded proprietor: Sanofi SA | Mentioned in the analysis (role not qualified) Also mentioned in 12 other decision(s): Sanofi v Reddy Pharma (CFI, 12 December 2025) · Zentiva France v Sanofi Mature IP (CFI, 24 January 2025) · Accord Healthcare v Sanofi (Paris Judicial Court, RG 21/06416, 2024) · Sanofi v Accord Healthcare (CFI, ORD_69482/2024, 15 September 2025) · Sanofi v Accord Healthcare (CFI, ORD_69480/2024, 15 September 2025) · Sanofi v Accord Healthcare (CFI, 17 July 2025) · Sanofi v Zentiva France (CFI, 27 June 2025) · Medac v Sanofi Mature IP (CFI, 19 March 2025) | 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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