UPC CFI 496/2024
Sep 2, 2024·EP2493466 · NOVEL ANTITUMORAL USE OF CABAZITAXEL
- Case details
- StatusCase Closed (Patent revoked)ActionCounterclaim for revocationCategoryCounterclaim for revocation
- Parties
- Claimants
- STADA Arzneimittel AGOperating co.
- STADA Nordic ApSOperating co.
- STADAPHARM GmbHOperating co.
Representatives- Konstantin Schallmoser-Bonabry
- Christian Meyer-Maiwald
- Anja Lunze-PENTARC Rechtsanwälte PartGmbB
- Daniel Hoppe-Bonabry
Respondents- Sanofi-Aventis Deutschland GmbHOperating co.
- Sanofi Mature IPOperating co.
- Sanofi B.V.Operating co.
- Sanofi S.r.l.Operating co.
- Sanofi Winthrop IndustrieOperating co.
- Sanofi-Aventis FranceOperating co.
- Sanofi BelgiumOperating co.
- Sanofi-Aventis GmbHOperating co.
- Sanofi - Produtos Farmaceuticos LdaOperating co.
- Sanofi ABOperating co.
- Sanofi A/SOperating co.
Representatives- Agathe Michel-De Cazotte-Carpmaels & Ransford
- Frédéric Chevallier-McDermott Will & Schulte
- Division
- Munich LD
- Technology
- ChemistryPharmaceuticals
- Language
- English
- First decided
- Dec 12, 2025
- EPO Opposition
- Glenmark Pharmaceuticals Europe Ltd2021-03-10
- Accord Healthcare LtdAdmissible2021-03-10
- Teva Pharmaceutical Industries Ltd.Admissible2021-03-10
- EVER Valinject GmbHWithdrawn2021-03-12
- Zentiva k.s.Admissible2021-03-12
- medac Gesellschaft für klinische Spezialpräparate mbHWithdrawn2021-03-22
- Fresenius Kabi Deutschland GmbHAdmissible2021-03-23
- Dr. Reddy's Laboratories Ltd.Admissible2021-03-31
- Betapharm Arzneimittel GmbHAdmissible2021-03-31
- Generics (U.K.) LimitedAdmissible2021-06-08
- Vossius & Partner Patentanwälte Rechtsanwälte mbBAdmissible2021-12-03
- STADA Arzneimittel AGAdmissible2021-12-09
- Maiwald GmbHAdmissible2021-12-10
- Accord Healthcare S.L.U.2024-08-30
| Patent revoked | Median days to first decision | |
|---|---|---|
| All UPC | 37% (34/91) | 124 |
| Munich LD | Locked | Locked |
| Judge Matthias Zigann | Locked | Locked |
| Judge Alima Zana | Locked | Locked |
| Judge Tobias Pichlmaier | Locked | Locked |
At the UPC: STADA Arzneimittel AG (9 cases)·Sanofi Group (33 cases)
This dispute contains 10 other proceedings
UPC CoA 22/2026·UPC CoA 25/2026·UPC CFI 106/2026·UPC CFI 108/2026·UPC CFI 146/2024 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
- 2025-12-12Infringement 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
- 2025-12-12Infringement 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
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| Receipt | 2026-03-31 | Not public |
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| Exhibit Defendant | 2026-03-31 | Not public |
| Application document Defendant | 2026-03-31 | Not public |
| Note | 2026-03-11 | Not public |
| Note | 2026-02-06 | Not public |
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| Application document Claimant | 2026-02-04 | Not public |
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| Exhibit document Applicant | 2026-01-12 | Not public |
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| Exhibit document Applicant | 2026-01-12 | Not public |
| Exhibit document Applicant | 2026-01-12 | Not public |
| Application document Applicant | 2026-01-12 | Not public |
| Case closed | 2025-12-16 | Not public |
| Decision | 2025-12-16 | Public |
| Decision | 2025-12-12 | Not public |
| Decision | 2025-12-12 | Not public |
| Other Documents | 2025-11-25 | Not public |
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| 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 |
| Acknowledgement-of-lodging | 2025-08-09 | Not public |
| Rejoinder | 2025-08-09 | Not public |
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| Acknowledgement-of-lodging | 2025-08-08 | Not public |
| Exhibit No. B.39 | 2025-08-08 | Not public |
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| Exhibit No. B.2.2.2 | 2025-08-08 | Not public |
| Exhibit No. 0.5 | 2025-08-08 | Not public |
| Exhibit No. B.30 | 2025-08-08 | Not public |
| Exhibit No. B.22.1bis | 2025-08-08 | Not public |
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| Exhibit No. B.37 | 2025-08-08 | Not public |
| Exhibit No. B.43 | 2025-08-08 | Not public |
| Exhibit No. B.36 | 2025-08-08 | Not public |
| Rejoinder | 2025-08-08 | Not public |
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| Exhibit No. B.2.2.1 | 2025-08-08 | Not public |
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| Exhibit No. B.42 | 2025-08-08 | Not public |
| Exhibit No. B.33 | 2025-08-08 | Not public |
| Acknowledgement-of-change-of-a-representative | 2025-07-11 | Not public |
| Application-RoP293-Receipt | 2025-07-11 | Not public |
| Formal-checks_Notification-of-positive-outcome | 2025-07-11 | Not public |
| Acknowledgement-of-change-of-a-representative | 2025-07-11 | Not public |
| Application-RoP293-Receipt | 2025-07-11 | Not public |
| Formal-checks_Notification-of-positive-outcome | 2025-07-11 | Not public |
| Acknowledgement-of-change-of-a-representative | 2025-07-11 | Not public |
| Application-RoP293-Receipt | 2025-07-11 | Not public |
| Formal-checks_Notification-of-positive-outcome | 2025-07-11 | Not public |
| Acknowledgement-of-change-of-a-representative | 2025-07-11 | Not public |
| Application-RoP293-Receipt | 2025-07-11 | Not public |
| Formal-checks_Notification-of-positive-outcome | 2025-07-11 | Not public |
| Acknowledgement-of-change-of-a-representative | 2025-07-11 | Not public |
| Application-RoP293-Receipt | 2025-07-11 | Not public |
| Formal-checks_Notification-of-positive-outcome | 2025-07-11 | Not public |
| Acknowledgement-of-change-of-a-representative | 2025-07-11 | Not public |
| Application-RoP293-Receipt | 2025-07-11 | Not public |
| Formal-checks_Notification-of-positive-outcome | 2025-07-11 | Not public |
| Acknowledgement-of-change-of-a-representative | 2025-07-11 | Not public |
| Application-RoP293-Receipt | 2025-07-11 | Not public |
| Formal-checks_Notification-of-positive-outcome | 2025-07-11 | Not public |
| Acknowledgement-of-change-of-a-representative | 2025-07-11 | Not public |
| Application-RoP293-Receipt | 2025-07-11 | Not public |
| Formal-checks_Notification-of-positive-outcome | 2025-07-11 | Not public |
| Acknowledgement-of-change-of-a-representative | 2025-07-11 | Not public |
| Application-RoP293-Receipt | 2025-07-11 | Not public |
| Formal-checks_Notification-of-positive-outcome | 2025-07-11 | Not public |
| Acknowledgement-of-change-of-a-representative | 2025-07-11 | Not public |
| Application-RoP293-Receipt | 2025-07-11 | Not public |
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| Acknowledgement-of-change-of-a-representative | 2025-07-11 | Not public |
| Application-RoP293-Receipt | 2025-07-11 | Not public |
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| Acknowledgement-of-change-of-a-representative | 2025-07-11 | Not public |
| Application-RoP293-Receipt | 2025-07-11 | Not public |
| Formal-checks_Notification-of-positive-outcome | 2025-07-11 | Not public |
| Application-RoP293 | 2025-07-10 | Not public |
| Application-RoP293 | 2025-07-10 | Not public |
| Application-RoP293 | 2025-07-10 | Not public |
| Application-RoP293 | 2025-07-10 | Not public |
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| 2025-07-08_Rejoinder_and_Reply_signiert | 2025-07-08 | Not public |
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| 2025-07-08_Rejoinder_and_Reply_signiert | 2025-07-08 | Not public |
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| 2025-07-08_Rejoinder_and_Reply_signiert | 2025-07-08 | Not public |
| Acknowledgement-of-lodging | 2025-07-08 | Not public |
| 2025-07-08_Rejoinder_and_Reply_signiert | 2025-07-08 | Not public |
| Application-RoP293 | 2025-06-27 | Not public |
| Application | 2025-06-27 | Not public |
| Hearing-Dates | 2025-01-24 | Not public |
| scheduling IC and OH for CC | 2025-01-24 | Public |
| Hearing-Dates | 2025-01-24 | 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 |
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| Hearing-Dates | 2025-01-13 | Not public |
| R 305 second- oral comments | 2025-01-13 | Not public |
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| Formal-checks_Notification-of-positive-outcome | 2024-11-01 | Not public |
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| Formal-checks_Notification-of-positive-outcome | 2024-11-01 | Not public |
| Acknowledgement-of-lodging | 2024-11-01 | Not public |
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| Formal-checks_Notification-of-positive-outcome | 2024-11-01 | Not public |
| Acknowledgement-of-lodging | 2024-11-01 | Not public |
| Reply and Defence | 2024-11-01 | Not public |
| Formal-checks_Notification-of-positive-outcome | 2024-11-01 | Not public |
| Acknowledgement-of-lodging | 2024-11-01 | Not public |
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| Acknowledgement-of-lodging | 2024-11-01 | Not public |
| Reply and Defence | 2024-11-01 | Not public |
| Formal-checks_Notification-of-positive-outcome | 2024-11-01 | Not public |
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| epoUploadDocumentsWorkflow | 2024-09-17 | Not public |
| Document from EPO | 2024-09-16 | Not public |
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| Acknowledgement of access to case | 2024-09-13 | Not public |
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| EPO-Request-for-case-pending | 2024-09-11 | Not public |
| Acknowledgement-of-lodging | 2024-09-11 | Not public |
| Formal-checks_Notification-of-positive-outcome | 2024-09-11 | Not public |
| Decision T 0096/20 of the EPO Boards of Appeal dated 22 April 2021 | 2024-09-02 | Not public |
| Tannock, et al., J. Clin. Oncol. 1996, 14(6), 1756-64. | 2024-09-02 | Not public |
| de Bono et al. article (cf. D15) as published on October 2, 2010 | 2024-09-02 | Not public |
| Winquist et al., The Canadian Journal of Urology, 15(1), February 2008 | 2024-09-02 | Not public |
| Decision T 0239/16, dated 13 September 2007 | 2024-09-02 | Not public |
| WO 96/30355 A1 published 3 October 1996 | 2024-09-02 | Not public |
| “Un projet de medicament stoppé in extremis”, Les Echos, 22 Dec 2009 | 2024-09-02 | Not public |
| Attard et al, Pathologie Biologie 54 (2006) 72-84 | 2024-09-02 | Not public |
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| Blog post by Dr Barry Mirtsching on “the Prostate Cancer blog”, dated 12 October 2007 | 2024-09-02 | Not public |
| Expert Opinion Dr. Kai Gevers dated 26 March 2021 | 2024-09-02 | Not public |
| FDA prescribing information of JEVTANA (cabazitaxel); revised in June 2010 | 2024-09-02 | Not public |
| FDA label for Taxotere (2007) | 2024-09-02 | Not public |
| EMA “ICH Topic E 8 General Considerations for Clinical Trials”, published March 1998. | 2024-09-02 | Not public |
| Extract relating to trial no. NCT00417079 dated 11 September 2009 | 2024-09-02 | Not public |
| Tribunal Judiciaire de Paris, Ordonnance de référé, 17 June 2021, N° RG 21/53849 – N° Portalis 352J-W-B7F-CUJG2 | 2024-09-02 | Not public |
| WO 2011/051894, original application | 2024-09-02 | Not public |
| Sartor et al., Urology 52 (2), 1998, 252-256 | 2024-09-02 | Not public |
| Goetz et al., Clinical Pharmacology, Proceedings of ASCO Volume 20 2001 | 2024-09-02 | Not public |
| Document “Information for the patient concerning the clinical study 42446 02041”, cited as “document 55” in EPO Boards o | 2024-09-02 | Not public |
| “Un projet de medicament stoppé in extremis”, Les Echos, 22 Dec 2009 | 2024-09-02 | Not public |
| Reuters newsclip confirming the date of D23 (AE14) | 2024-09-02 | Not public |
| Shigeta et al., Correspondence, The Lancet, 377, 2011, 121-122 | 2024-09-02 | Not public |
| Expert Opinion Dr. Kai Gevers dated 26 March 2021 | 2024-09-02 | Not public |
| Document “Zeltia Junta General de Accionistas 2003”, cited as “document D2”in EPO Boards of Appeal decision T 2506/12 | 2024-09-02 | Not public |
| Sternberg et al. Oncology 2013;85: 208-215 | 2024-09-02 | Not public |
| Summary of product characteristics of Taxotere; revision of November 2008 | 2024-09-02 | Not public |
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| Curriculum Vitae of Prof. Dr. Kurt Miller | 2024-09-02 | Not public |
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| Pivot et al., Annals of Oncology, 19, 2008, 1547-1552 | 2024-09-02 | Not public |
| Guidance document entitled “Cabazitaxel (XRP-6258) for hormone refractory, metastatic prostate cancer – second line afte | 2024-09-02 | Not public |
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| T 3165/19 of the EPO Boards of Appeal dated 9 January 2023 | 2024-09-02 | Not public |
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| Counterclaim for revocation | 2024-09-02 | Not public |
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| Blog posts by Dr Barry Mirtsching on the “Center for Oncology Research & Treatment-Dallas, TX Innovative Cancer Treatmen | 2024-09-02 | Not public |
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| Decision T 2506/12 of the EPO Boards of Appeal dated 4 October 2016 | 2024-09-02 | Not public |
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| Tribunal Judiciaire de Paris, Ordonnance de référé, 17 June 2021, N° RG 21/53849 – N° Portalis 352J-W-B7F-CUJG2 | 2024-09-02 | Not public |
| MPEP Section 601 | 2024-09-02 | Not public |
| Assignment before the USPTO | 2024-09-02 | Not public |
| Tannock et al., N Engl J Med 2004, 351(15), 1502-1512 | 2024-09-02 | Not public |
| EMA Assessment Report for Jevtana (cabazitaxel), 20 January 2011 | 2024-09-02 | Not public |
| List of documents from the EPO opposition proceedings (includes further documents on which this statement of defence and | 2024-09-02 | Not public |
| T 2963/19 of the EPO Boards of Appeal dated 18 March 2022 | 2024-09-02 | Not public |
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| Expert declaration by Prof. Muller including Annexes 1 to 5 cited therein | 2024-09-02 | Not public |