UPC CFI 146/2024
May 13, 2024·EP2493466: NOVEL ANTITUMORAL USE OF CABAZITAXEL
- Case details
- StatusCase ClosedActionInfringementCategoryMain Infringement Action
- Parties
- Claimants
- Sanofi Mature IP
- Sanofi Winthrop Industrie
- Sanofi-Aventis France
- Sanofi-Aventis GmbH
- Sanofi Belgium
- Sanofi-Aventis Deutschland GmbH
- Sanofi S.r.l.
- Sanofi B.V.
- Sanofi - Produtos Farmaceuticos Lda
- Sanofi AB
- Sanofi A/S
Reps: Frédéric Chevallier (McDermott Will & Schulte)RespondentsReps: 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
- 2025-12-12Infringement 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 - 2025-12-12RevokedInfringement 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
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| Note | 2026-04-15 | Not public |
| Receipt | 2026-03-31 | Not public |
| Cover sheet | 2026-03-31 | Not public |
| Exhibit Defendant | 2026-03-31 | Not public |
| Application document Defendant | 2026-03-31 | Not public |
| Note | 2026-03-11 | Not public |
| action.issueDecision.decision | 2026-02-13 | Not public |
| Final Order | 2026-02-13 | Public |
| Note | 2026-02-06 | Not public |
| Receipt | 2026-02-04 | Not public |
| Cover sheet | 2026-02-04 | Not public |
| Application document Claimant | 2026-02-04 | Not public |
| Receipt | 2026-02-04 | Not public |
| Cover sheet | 2026-02-04 | Not public |
| Application document Claimant | 2026-02-04 | Not public |
| Receipt | 2026-01-12 | Not public |
| Cover sheet | 2026-01-12 | Not public |
| Exhibit document Applicant | 2026-01-12 | Not public |
| Exhibit document Applicant | 2026-01-12 | Not public |
| Exhibit document Applicant | 2026-01-12 | Not public |
| Exhibit document Applicant | 2026-01-12 | Not public |
| Application document Applicant | 2026-01-12 | Not public |
| action.issueOrder.order | 2026-01-09 | Not public |
| Order | 2026-01-09 | Not public |
| action.phaseChange.caseClose | 2025-12-16 | Not public |
| Decision | 2025-12-16 | Public |
| action.issueDecision.decision | 2025-12-12 | Not public |
| Decision | 2025-12-12 | Not public |
| Other Documents | 2025-11-19 | Not public |
| Cover sheet | 2025-11-03 | Not public |
| Application document Claimant | 2025-11-03 | Not public |
| Receipt | 2025-11-03 | Not public |
| Headnote-and-Keywords | 2025-09-15 | Not public |
| Interim-Procedure-Closure | 2025-09-15 | Not public |
| Summon-Oral-Hearing | 2025-09-15 | Not public |
| summons party expert witnesses | 2025-09-15 | Not public |
| R 105.5 - 2nd interim conference - 12 Sep. 2025 | 2025-09-15 | Not public |
| Hearing-Dates | 2025-09-15 | Not public |
| R 105.5 - 2nd interim conference - 12 Sep. 2025 | 2025-09-15 | Not public |
| oral hearing reference - IC | 2025-09-15 | Not public |
| oral hearing reference - IC | 2025-09-15 | Not public |
| Fix-Interim-Conference-Date | 2025-09-10 | Not public |
| Interim-Conference-Decision | 2025-09-10 | Not public |
| Written-Procedure-Closure | 2025-09-10 | Not public |
| Receipt | 2025-09-02 | Not public |
| Application | 2025-09-01 | Not public |
| Receipt | 2025-08-11 | Not public |
| Rule 9 request | 2025-08-09 | Not public |
| Headnote-and-Keywords | 2025-07-17 | Not public |
| R 105.5 RoP | 2025-07-17 | Public |
| Acknowledgement-of-change-of-a-representative | 2025-07-11 | Not public |
| Acknowledgement-of-change-of-a-representative | 2025-07-11 | Not public |
| Acknowledgement-of-change-of-a-representative | 2025-07-11 | Not public |
| Acknowledgement-of-change-of-a-representative | 2025-07-11 | Not public |
| Acknowledgement-of-change-of-a-representative | 2025-07-11 | Not public |
| Acknowledgement-of-change-of-a-representative | 2025-07-11 | Not public |
| Acknowledgement-of-change-of-a-representative | 2025-07-11 | Not public |
| Acknowledgement-of-change-of-a-representative | 2025-07-11 | Not public |
| Acknowledgement-of-change-of-a-representative | 2025-07-11 | Not public |
| Acknowledgement-of-change-of-a-representative | 2025-07-11 | Not public |
| Acknowledgement-of-change-of-a-representative | 2025-07-10 | Not public |
| Application-RoP293-Receipt | 2025-07-10 | Not public |
| Formal-checks_Notification-of-positive-outcome | 2025-07-10 | Not public |
| Application-RoP293-Receipt | 2025-07-10 | Not public |
| Formal-checks_Notification-of-positive-outcome | 2025-07-10 | Not public |
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| Application-RoP293-Receipt | 2025-07-10 | Not public |
| Formal-checks_Notification-of-positive-outcome | 2025-07-10 | Not public |
| Application-RoP293-Receipt | 2025-07-10 | Not public |
| Formal-checks_Notification-of-positive-outcome | 2025-07-10 | Not public |
| Application-RoP293-Receipt | 2025-07-10 | Not public |
| Formal-checks_Notification-of-positive-outcome | 2025-07-10 | Not public |
| Application-RoP293-Receipt | 2025-07-10 | Not public |
| Formal-checks_Notification-of-positive-outcome | 2025-07-10 | Not public |
| Application-RoP293-Receipt | 2025-07-10 | Not public |
| Formal-checks_Notification-of-positive-outcome | 2025-07-10 | Not public |
| Application-RoP293-Receipt | 2025-07-10 | Not public |
| Formal-checks_Notification-of-positive-outcome | 2025-07-10 | Not public |
| Application-RoP293-Receipt | 2025-07-10 | Not public |
| Formal-checks_Notification-of-positive-outcome | 2025-07-10 | Not public |
| Application-RoP293-Receipt | 2025-07-10 | Not public |
| Formal-checks_Notification-of-positive-outcome | 2025-07-10 | Not public |
| Acknowledgement-of-lodging | 2025-07-08 | Not public |
| 2025-07-08_Rejoinder_and_Reply_signiert | 2025-07-08 | Not public |
| Acknowledgement-of-lodging | 2025-07-08 | Not public |
| Rejoinder_to_Reply_and_Reply_to_Defence_Counterclaim | 2025-07-08 | Not public |
| Application-RoP293 | 2025-06-27 | Not public |
| Application-RoP293 | 2025-06-27 | Not public |
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| Application-RoP293 | 2025-06-27 | Not public |
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| Application-RoP293 | 2025-06-27 | Not public |
| Application-RoP293 | 2025-06-27 | Not public |
| Application-RoP293 | 2025-06-27 | Not public |
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| Application | 2025-06-27 | Not public |
| Comments | 2025-05-15 | Not public |
| Preliminary_Objection_DecisionOutcome | 2025-05-14 | Not public |
| R 20.2 | 2025-05-14 | Not public |
| R 20.2 | 2025-05-14 | Public |
| Hearing Reference | 2025-05-14 | Not public |
| Hearing Reference | 2025-05-14 | Not public |
| order 8 May 2025 tailored | 2025-05-11 | Not public |
| confidentialty - oberservations | 2025-05-11 | Not public |
| order 8 May 2025 tailored | 2025-05-11 | Not public |
| Headnote-and-Keywords | 2025-05-09 | Not public |
| Outcome of the Order | 2025-05-08 | Not public |
| final order | 2025-05-08 | Not public |
| final order | 2025-05-08 | Public |
| Preliminary_Objection_DecisionOutcome | 2025-05-08 | Not public |
| final order | 2025-05-08 | Public |
| final order | 2025-05-08 | Not public |
| Outcome of the Order | 2025-05-08 | Not public |
| final order | 2025-05-08 | Public |
| final order | 2025-05-08 | Not public |
| Receipt | 2025-04-10 | Not public |
| Comments_ORD_10065/2025 | 2025-04-09 | Not public |
| Outcome of the Order | 2025-03-21 | Not public |
| 262 A - final | 2025-03-21 | Public |
| 262 A - final | 2025-03-21 | Public |
| Comments No. 2 Rule 105(5) RoP (STADA - redacted) | 2025-03-20 | Not public |
| Comments No. 2 Rule 105(5) RoP (STADA - unredacted) | 2025-03-20 | Not public |
| Comments No. 2 Rule 105(5) RoP (STADA - unredacted) | 2025-03-20 | Not public |
| Exhibit No. F.05 | 2025-03-20 | Not public |
| Exhibit No. B.01.1.2.b | 2025-03-20 | Not public |
| Exhibit No. F.04 | 2025-03-20 | Not public |
| Exhibit No. F.03 | 2025-03-20 | Not public |
| Exhibit No. B.01.1.c | 2025-03-20 | Not public |
| Exhibit No. F.06 | 2025-03-20 | Not public |
| comments | 2025-02-27 | Not public |
| Formal response to the Order of the Court | 2025-02-12 | Not public |
| Comments 263 RoP | 2025-01-29 | Not public |
| R 105.5 - 15 Jan. 2025 | 2025-01-22 | Not public |
| R 105.5 - 15 Jan. 2025 | 2025-01-22 | Public |
| Exhibit No. D.04 - New redacted version | 2025-01-17 | Not public |
| Outcome of the Order | 2025-01-17 | Not public |
| R 305 second - final | 2025-01-17 | Public |
| Hearing Reference | 2025-01-16 | Not public |
| Hearing Reference | 2025-01-16 | Not public |
| App_57839/2024 UPC_CFI_146/2024- R 262A - final_anonymized | 2025-01-15 | Not public |
| R 262 A - final | 2025-01-14 | Public |
| R 262 A - final | 2025-01-14 | Not public |
| Hearing-Dates | 2025-01-13 | Not public |
| R 305 second- oral comments | 2025-01-13 | Not public |
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| Receipt | 2025-01-09 | Not public |
| Hearing-Dates | 2025-01-09 | Not public |
| R 19 - oral argument hearing | 2025-01-09 | Not public |
| Exhibit No. A.02.2 | 2025-01-09 | Not public |
| Application | 2025-01-09 | Not public |
| Headnote-and-Keywords | 2025-01-07 | Not public |
| Outcome of the Order | 2025-01-07 | Not public |
| R 305-310 final | 2025-01-07 | Public |
| Acknowledgement-of-lodging | 2025-01-06 | Not public |
| Application change of representative details | 2025-01-06 | Not public |
| R 262 A - comments | 2025-01-03 | Not public |
| Outcome of the Order | 2024-12-19 | Not public |
| extension request | 2024-12-19 | Public |
| Receipt | 2024-12-13 | Not public |
| Receipt | 2024-12-13 | Not public |
| Reply and Defence | 2024-12-13 | Not public |
| Extension request | 2024-12-12 | Not public |
| Comments pursuant to RoP264 | 2024-11-12 | Not public |
| Comments pursuant to RoP264 | 2024-11-12 | Not public |
| Comments pursuant to RoP264 | 2024-11-12 | Not public |
| R 37.2 final signed | 2024-11-12 | Public |
| Comment on application RoP 262A | 2024-11-05 | Not public |
| Comment on Application RoP 305 | 2024-11-05 | Not public |
| Receipt | 2024-11-04 | Not public |
| Application | 2024-11-01 | Not public |
| Exhibit No. D.04 (UNREDACTED) | 2024-11-01 | Not public |
| Exhibit No. D.04 (REDACTED) | 2024-11-01 | Not public |
| Acknowledgement-of-lodging | 2024-11-01 | Not public |
| Reply and Defence | 2024-11-01 | Not public |
| Acknowledgement-of-lodging | 2024-11-01 | Not public |
| Reply and Defence | 2024-11-01 | Not public |
| Acknowledgement-of-lodging | 2024-11-01 | Not public |
| Exhibit No. B.16.2 | 2024-11-01 | Not public |
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| Exhibit No. B.07.3 | 2024-11-01 | Not public |
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| Exhibit No. D.01.5 | 2024-11-01 | Not public |
| Exhibit No. B.09.1 | 2024-11-01 | Not public |
| Exhibit No. B.25 (6) | 2024-11-01 | Not public |
| Exhibit No. F.02 | 2024-11-01 | Not public |
| Exhibit No. B.13 | 2024-11-01 | Not public |
| Exhibit No. B.28 | 2024-11-01 | Not public |
| Exhibit No. B.23.1 | 2024-11-01 | Not public |
| Exhibit No. B.16.1 | 2024-11-01 | Not public |
| Exhibit No. F.01.1 (1) | 2024-11-01 | Not public |
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| Exhibit No. B.04.8 | 2024-11-01 | Not public |
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| Exhibit No. G.07 | 2024-11-01 | Not public |
| Exhibit No. 0.4 | 2024-11-01 | Not public |
| Exhibit No. D.01.3 | 2024-11-01 | Not public |
| Exhibit No. D.02.3 | 2024-11-01 | Not public |
| Exhibit No. B.10 | 2024-11-01 | Not public |
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| Exhibit No. F.01 | 2024-11-01 | Not public |
| Exhibit No. G.05 | 2024-11-01 | Not public |
| Exhibit No. B.25 (2) | 2024-11-01 | Not public |
| Exhibit No. B.22.2 | 2024-11-01 | Not public |
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| Exhibit No. B.27 | 2024-11-01 | Not public |
| Exhibit No. B.29 (2) | 2024-11-01 | Not public |
| Exhibit No. B.19 | 2024-11-01 | Not public |
| Exhibit No. B.07.2 | 2024-11-01 | Not public |
| Exhibit No. B.22.3 | 2024-11-01 | Not public |
| Exhibit No. B.04.4 | 2024-11-01 | Not public |
| Exhibit No. B.07.4 | 2024-11-01 | Not public |
| Reply and Defence | 2024-11-01 | Not public |
| Exhibit No. B.07.5 | 2024-11-01 | Not public |
| Exhibit No. D.04 (UNREDACTED) | 2024-11-01 | Not public |
| Exhibit No. B.25 (1) | 2024-11-01 | Not public |
| Exhibit No. D.04 (UNREDACTED) | 2024-11-01 | Not public |
| Exhibit No. B.21 | 2024-11-01 | Not public |
| Exhibit No. B.25 (5) | 2024-11-01 | Not public |
| Exhibit No. B.04.3 | 2024-11-01 | Not public |
| Exhibit No. B.25 (3) | 2024-11-01 | Not public |
| Exhibit No. B.04.6 | 2024-11-01 | Not public |
| Exhibit No. A.02 | 2024-11-01 | Not public |
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| Exhibit No. B.01.1b | 2024-11-01 | Not public |
| Exhibit No. B.20 | 2024-11-01 | Not public |
| Exhibit No. G.03 | 2024-11-01 | Not public |
| Exhibit No. B.04.5 | 2024-11-01 | Not public |
| Exhibit No. D.01.4 | 2024-11-01 | Not public |
| Exhibit No. B.07.6 | 2024-11-01 | Not public |
| Exhibit No. G.06 | 2024-11-01 | Not public |
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| Exhibit No. B.18 | 2024-11-01 | Not public |
| Exhibit No. B.03 | 2024-11-01 | Not public |
| Exhibit No. B.22.1 | 2024-11-01 | Not public |
| Exhibit No. F.01.2 | 2024-11-01 | Not public |
| Exhibit No. B.04.1 | 2024-11-01 | Not public |
| Exhibit No. B.06 | 2024-11-01 | Not public |
| Exhibit No. B.11 | 2024-11-01 | Not public |
| Exhibit No. G.04 | 2024-11-01 | Not public |
| Exhibit No. F.01.4 | 2024-11-01 | Not public |
| Exhibit No. B.14 | 2024-11-01 | Not public |
| Exhibit No. F.01.1 (3) | 2024-11-01 | Not public |
| Exhibit No. B.05.1 | 2024-11-01 | Not public |
| Exhibit No. B.07.1 | 2024-11-01 | Not public |
| Exhibit No. B.25 (4) | 2024-11-01 | Not public |
| Exhibit No. F.01.1 (2) | 2024-11-01 | Not public |
| Exhibit No. G.02 | 2024-11-01 | Not public |
| Exhibit No. B.29 (1) | 2024-11-01 | Not public |
| Exhibit No. B.05 | 2024-11-01 | Not public |
| Exhibit No. D.02.2 | 2024-11-01 | Not public |
| Exhibit No. B.09 | 2024-11-01 | Not public |
| Exhibit No. B.17.1 | 2024-11-01 | Not public |
| Application | 2024-10-23 | Not public |
| Exhibit No. A.02.1 | 2024-10-23 | Not public |
| Exhibit No. A.02.1 | 2024-10-23 | Not public |
| Comments pursuant to RoP264 | 2024-10-11 | Not public |
| Comments pursuant to RoP264 | 2024-10-11 | Not public |
| Comments pursuant to RoP264 | 2024-10-11 | Not public |
| Comments pursuant to RoP264 | 2024-10-11 | Not public |
| Comments pursuant to RoP264 | 2024-10-11 | Not public |
| Comments pursuant to RoP264 | 2024-10-11 | Not public |
| Comments pursuant to RoP264 | 2024-10-11 | Not public |
| Comments pursuant to RoP264 | 2024-10-11 | Not public |
| Cabazitaxel comments preliminary objection | 2024-10-11 | Not public |
| Cabazitaxel comments to preliminary objection | 2024-10-11 | Not public |
| Cabazitaxel comments to preliminary objection | 2024-10-11 | Not public |
| Cabazitaxel comments to preliminary objection | 2024-10-11 | Not public |
| Cabazitaxel comments on reply to objection | 2024-10-11 | Not public |
| Comments on bifurcation | 2024-10-07 | Not public |
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| R 37.2 - comments | 2024-10-01 | Not public |
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| Hearing-Dates | 2024-09-16 | Not public |
| scheduling - final | 2024-09-16 | Public |
| Panel-Appointment | 2024-09-16 | Not public |
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| 2024-09-13_Reply_to_Court_order | 2024-09-13 | Not public |
| 2024-09-13_Reply_to_Court_order | 2024-09-13 | Not public |
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| scheduling - comments | 2024-09-10 | Not public |
| Hearing-Dates | 2024-09-10 | Not public |
| Formal-checks_Notification-of-positive-outcome | 2024-09-03 | Not public |
| Formal-checks_Notification-of-positive-outcome | 2024-09-03 | Not public |
| Formal-checks_Notification-of-positive-outcome | 2024-09-03 | Not public |
| Acknowledgement-of-lodging | 2024-09-02 | Not public |
| D20a | 2024-09-02 | Not public |
| D10 | 2024-09-02 | Not public |
| D!6 | 2024-09-02 | Not public |
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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.
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 approachNote: 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 EPCNote: 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 EPCNote: 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 EPCNote: Court found the 225 mg/m² limitation to be arbitrary or to respond to the same technical problem without a distinct technical effect.
EP 2 493 466 (cabazitaxel antitumour use patent) is valid over the prior art
ClaimantLegal basis: Art. 56 EPCReason: 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 RoPReason: Sanofi did not file a R. 30 RoP application for patent amendment; therefore no auxiliary requests were available to consider.
Browse other cases on this principle.
- NHSC document (clinical/regulatory document disclosing cabazitaxel antitumour use in docetaxel-pretreated patients)Novelty-destroying