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UPC CFI 146/2024

May 13, 2024·EP2493466 · NOVEL ANTITUMORAL USE OF CABAZITAXEL

Action number: ACT 16116/2024

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Case details
Status
Case Closed (No infringement)
Action
Infringement
Category
Main infringement action
Parties
Claimants
Representatives
Respondents
Representatives
Division
Munich LD
Judges
Technology
  • Chemistry
    Pharmaceuticals
Language
English
First decided
Sep 15, 2025
Last decision
Dec 12, 2025
EPO Opposition
How this compares
The court's record for this kind of case, counted in first-instance rulings. A figure in brackets is the number of rulings a rate rests on.
Infringement foundMedian days to first decision
All UPC53% (62/117)124
Munich LDLockedLocked
Judge Matthias ZigannLockedLocked
Judge Alima ZanaLockedLocked
Judge Tobias PichlmaierLockedLocked
Judge Carola WagnerLockedLocked

At the UPC: Sanofi Group (33 cases)·STADAPHARM GmbH (10 cases)

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Related cases
All proceedings on this patent

This dispute contains 10 other proceedings

UPC CoA 22/2026·UPC CoA 25/2026·UPC CFI 106/2026·UPC CFI 108/2026·UPC CFI 496/2024 and 5 more

10 other defendants litigating the same or a related patent

UPC CoA 23/2026·UPC CoA 24/2026·UPC CoA 26/2026·UPC CoA 27/2026·UPC CFI 503/2024 and 5 more

Start a free trial to see how each one ended.

More cases: Munich LD·2024

Decisions
  • 2025-12-12
    Infringement ActionPublic

    Summary: The Munich Local Division issued a rectification order under Rule 353 RoP correcting factual errors in a prior decision in the Sanofi v. Stada/Dr Reddy/Zentiva proceedings, including corrections regarding marketing authorisation holders and expert witness attribution.

    Show the legal issues (1)
    • Rectification of decisions Rule 353 RoP
  • 2025-12-12
    Infringement ActionPublic

    Summary: The Munich Local Division found patent EP 2 493 466 (relating to cabazitaxel pharmaceutical formulations) invalid for lack of inventive step in infringement proceedings brought by Sanofi against STADA, Dr. Reddy's and Zentiva entities, dismissing the infringement claims.

    Show the legal issues (4)
    • Inventive step (cabazitaxel formulation)
    • Infringement
    • Pharmaceutical patent
    • Counterclaim for revocation
  • 2025-09-15
    Infringement ActionPublic

    Summary: Procedural scheduling order by Munich Local Division (UPC_CFI_145-148/2024, 15 September 2025) summoning party experts to oral hearing on 14-17 October 2025 in four consolidated infringement proceedings by Sanofi entities against Accord Healthcare, STADA, Reddy Pharma/betapharm and Zentiva groups concerning EP 2 493 466.

    Show the legal issues (2)
    • Summons of party experts to oral hearing (R. 177.2, 181.1 RoP)
    • Consolidated infringement actions
Documents
Show all 688 documents
Document titleDatePublic
Note2026-04-15Not public
Receipt2026-03-31Not public
Cover sheet2026-03-31Not public
Exhibit Defendant2026-03-31Not public
Application document Defendant2026-03-31Not public
Note2026-03-11Not public
Decision2026-02-13Not public
Final Order2026-02-13Public
Note2026-02-06Not public
Receipt2026-02-04Not public
Coverage: Partial.Reasoning extracted with partial coverage — some sections may be incomplete.
Plain-English summary

Sanofi (and related entities) brought infringement actions against STADA, Dr. Reddy's, and Zentiva entities based on EP 2 493 466, a patent covering the antitumoral use of cabazitaxel (Jevtana) in patients pretreated with docetaxel. The Munich Local Division found the patent invalid in its entirety (claims 1-9) for lack of inventive step, the NHSC regulatory document disclosing all essential features of claim 1 without any distinct technical effect being established for the dependent claims; Sanofi filed no amendment requests, and the infringement actions were dismissed with costs against Sanofi.

Accepted arguments
What the court agreed with — by party.

  • Cabazitaxel patent EP 2 493 466 lacks inventive step over the prior art (NHSC document disclosing cabazitaxel's antitumour use in docetaxel-pretreated patients)

    RespondentLegal basis: Art. 56 EPC; problem-solution approach

    Note: Court found that the NHSC document disclosed the claimed antitumoral use of cabazitaxel, and that the skilled person would have expected this use without inventive step; no distinct technical effect was established for dependent claims relating to solvate form, dosing, or patient selection.

  • Dependent claims 3-4 (acetone solvate) lack inventive step as providing a specific solvate is common general knowledge

    RespondentLegal basis: Art. 56 EPC

    Note: Court accepted that the acetone solvate form features were not linked to a technical effect and are within common general knowledge.

  • Claims 5-7 (cabazitaxel/prednisone doses and 3-week interval) disclosed in the NHSC document

    RespondentLegal basis: Art. 56 EPC

    Note: Court accepted that dose and interval claims were disclosed in the NHSC document.

  • Claim 9 (prior docetaxel dose of at least 225 mg/m²) does not provide a distinct technical effect

    RespondentLegal basis: Art. 56 EPC

    Note: Court found the 225 mg/m² limitation to be arbitrary or to respond to the same technical problem without a distinct technical effect.

Rejected arguments
What the court did not agree with — and why.

  • EP 2 493 466 (cabazitaxel antitumour use patent) is valid over the prior art

    ClaimantLegal basis: Art. 56 EPC

    Reason: Court found claims 1-9 invalid for lack of inventive step based on the NHSC document as closest prior art; no distinct technical effect established for any dependent claim feature.

  • No auxiliary requests for patent amendment filed

    ClaimantLegal basis: R. 30 RoP

    Reason: Sanofi did not file a R. 30 RoP application for patent amendment; therefore no auxiliary requests were available to consider.

Key legal principles
Doctrines and rules cited in the reasoning.
Problem-solution approach applied to pharmaceutical second medical use: prior art disclosure of use negates inventive step absent distinct technical effectSpecific solvate forms within common general knowledge do not establish inventive step without a linked technical effectArbitrary limitations or limitations responding to the same problem without distinct technical effect do not confer inventive stepWhere patent is invalid in its entirety, infringement actions are dismissedPatentee that fails to file R. 30 RoP amendment request has no auxiliary requests to consider

Browse other cases on this principle.

Prior art relied on
References cited and the role they played.
  • NHSC document (clinical/regulatory document disclosing cabazitaxel antitumour use in docetaxel-pretreated patients)Novelty-destroying