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UPC CFI 146/2024

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

Case details
Status
Case Closed
Action
Infringement
Category
Main Infringement Action
Parties
Respondents
Reps: Daniel Hoppe (Bonabry); Christian Meyer (Maiwald Intellectual Property); Anja Lunze (PENTARC)
Division
Munich LD
Technology
Pharmaceuticals · Small Molecule · Pharmaceutical & Medical
Language
English
First decided
Dec 12, 2025
Claims
At issue1, 2, 3, 4, 5, 6, 7, 8, 9
Revoked1, 2, 3, 4, 5, 6, 7, 8, 9
Notes: Munich LD revoked EP2493466 (cabazitaxel antitumoral use) in its entirety, claims 1 to 9, for lack of inventive step; infringement actions dismissed.
Decisions
  • 2025-12-12
    Infringement Action

    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.

    Legal issues:Rectification of decisions Rule 353 RoP
  • 2025-12-12
    RevokedInfringement meritsInfringement Action

    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.

    Legal issues:Inventive step (cabazitaxel formulation)InfringementPharmaceutical patentCounterclaim for revocation
Documents
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action.phaseChange.caseClose2025-12-16Not public
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Comments_ORD_10065/20252025-04-09Not public
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commentPreliminaryObjection2024-07-05Not public
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Written comments2024-07-05Not public
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commentPreliminaryObjection2024-07-05Not public
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Written comments2024-07-05Not public
Exhibit No. E.1.12024-07-05Not public
preliminaryObjection2024-06-27Not public
Preliminary objection2024-06-27Not public
Acknowledgement of access to case2024-06-26Not public
Notification Of Service2024-06-25Not public
Proof of service2024-06-25Not public
preliminaryObjection2024-06-24Not public
Preliminary objection2024-06-22Not public
Panel-Appointment2024-06-03Not public
Notification Of Service2024-05-28Not public
Proof of service2024-05-28Not public
Notification Of Service2024-05-28Not public
Proof of service2024-05-28Not public
Acknowledgement of access to case2024-05-24Not public
Acknowledgement of access to case2024-05-24Not public
epoUploadDocumentsWorkflow2024-05-23Not public
Document from EPO2024-05-22Not public
Letter for Service2024-05-16Not public
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Letter for Service2024-05-16Not public
Panel-Appointment2024-05-16Not public
EPO-Request-for-case-pending2024-05-16Not public
Receipt2024-05-16Not public
Formal-checks_Notification-of-positive-outcome2024-05-16Not public
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Exhibit No. B.1.22024-05-14Not public
Exhibit No. B.1.1.22024-05-14Not public
Exhibit No. D.1.12024-05-14Not public
Amended Statement of claim2024-05-14Not public
Statement of claim2024-05-14Not public
Exhibit No. D.22024-05-14Not public
Exhibit No. B.1.1.12024-05-14Not public
Exhibit No. A.1.12024-05-14Not public
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Exhibit No. B.1.12024-05-14Not public
Exhibit No. B.12024-05-14Not public
Formal-checks_Request-for-correction2024-05-14Not public
Acknowledgement-of-lodging2024-05-13Not public
Exhibit No. A.1.12024-05-13Not public
Exhibit No. 0.12024-05-13Not public
Exhibit No. 0.12024-05-13Not public
Exhibit No. B.2.52024-05-13Not public
Exhibit No. B.2.32024-05-13Not public
Exhibit No. D.1.12024-05-13Not public
Exhibit No. C.12024-05-13Not public
Exhibit No. A.12024-05-13Not public
Exhibit No. B.2.12024-05-13Not public
Exhibit No. D.2.12024-05-13Not public
Exhibit No. D.22024-05-13Not public
Exhibit No. 0.32024-05-13Not public
Exhibit No. B.1.22024-05-13Not public
Exhibit No. C.1.22024-05-13Not public
Exhibit No. B.1.1.12024-05-13Not public
Exhibit No. B.2.22024-05-13Not public
Exhibit No. B.1.1.22024-05-13Not public
Exhibit No. 0.22024-05-13Not public
Exhibit No. B.12024-05-13Not public
Exhibit No. 0.22024-05-13Not public
Exhibit No. 0.32024-05-13Not public
Exhibit No. D.1.22024-05-13Not public
Statement of claim2024-05-13Not public
Exhibit No. B.1.12024-05-13Not public
Exhibit No. B.2.42024-05-13Not 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.

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