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UPC CFI 463/2024
Aug 30, 2024·EP2493466: NOVEL ANTITUMORAL USE OF CABAZITAXEL
Parent infringement case:UPC CFI 145/2024
- Case details
- StatusCase ClosedActionCounterclaim for revocationCategoryCounter Claim for Revocation
- Parties
- Division
- Munich LD
- Technology
- Pharmaceuticals · Small Molecule · Pharmaceutical & Medical
- Language
- English
Documents
| Document title | Date | Public |
|---|---|---|
| action.phaseChange.caseClose | 2025-11-27 | Not public |
| Other Documents | 2025-11-25 | Not public |
| action.phaseChange.oralPhaseClose | 2025-10-11 | Not public |
| action.issueDecision.decision | 2025-10-11 | Not public |
| Final Order | 2025-10-11 | Public |
| Cover sheet | 2025-10-10 | Not public |
| Application | 2025-10-10 | Not public |
| Signature image | 2025-10-10 | Not public |
| Receipt | 2025-10-10 | Not public |
| Cover sheet | 2025-10-10 | Not public |
| Other document | 2025-10-10 | Not public |
| Receipt | 2025-10-10 | Not public |
| Cover sheet | 2025-10-08 | Not public |
| Further pleadings | 2025-10-08 | Not public |
| Exhibit | 2025-10-08 | Not public |
| Receipt | 2025-10-08 | Not public |
| Cover sheet | 2025-10-08 | Not public |
| Further pleadings | 2025-10-08 | Not public |
| Exhibit | 2025-10-08 | Not public |
| Receipt | 2025-10-08 | 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 |
| Acknowledgement-of-lodging | 2025-08-08 | Not public |
| Exhibit No. B.2.2.1 | 2025-08-08 | Not public |
| Exhibit No. B.22.1bis | 2025-08-08 | Not public |
| Exhibit No. B.34 | 2025-08-08 | Not public |
| Exhibit No. B.37 | 2025-08-08 | Not public |
| Exhibit No. B.31 | 2025-08-08 | Not public |
| Exhibit No. B.43 | 2025-08-08 | Not public |
| Exhibit No. 0.5 | 2025-08-08 | Not public |
| Exhibit No. B.2.2.2 | 2025-08-08 | Not public |
| Exhibit No. B.32 | 2025-08-08 | Not public |
| Exhibit No. B.30 | 2025-08-08 | Not public |
| Exhibit No. B.41 | 2025-08-08 | Not public |
| Exhibit No. B.36 | 2025-08-08 | Not public |
| Exhibit No. B.38 | 2025-08-08 | Not public |
| Exhibit No. B.35 | 2025-08-08 | Not public |
| Exhibit No. B.39 | 2025-08-08 | Not public |
| Rejoinder | 2025-08-08 | Not public |
| Exhibit No. B.42 | 2025-08-08 | Not public |
| Exhibit No. B.33 | 2025-08-08 | Not public |
| Exhibit No. B.40 | 2025-08-08 | Not public |
| Outcome of the Order | 2025-07-16 | Not public |
| 262 A - final (again for the old CMS) | 2025-07-16 | Public |
| 262 A - final | 2025-07-16 | Public |
| Acknowledgement-of-change-of-a-representative | 2025-07-11 | Not public |
| ACT_16112-2024 and 4499-2024 Accord Application 262A RoP 8 July 2025.pdf | 2025-07-09 | Not public |
| ACT_16112-2024 and 4499-2024 Accord Reply to the Defence to the Counterclaim and Rejoinder UNREDACTED version 8 July 202 | 2025-07-09 | Not public |
| ACT_16112-2024 and 4499-2024 Accord Reply to the Defence to the Counterclaim and Rejoinder REDACTED version 8 July 2025. | 2025-07-09 | Not public |
| Acknowledgement-of-lodging | 2025-07-09 | Not public |
| Exhibit TW 8.16 Accord s Comments on Sanofi s further amended requests - filed 9 April 2025.pdf | 2025-07-09 | Not public |
| Exhibit TW 6.3 - Paris Court Judgment issued on 6 September 2024 Accord v Sanofi RG 21-06416.pdf | 2025-07-09 | Not public |
| Exhibit TW 8.2 UPC_CFI_145-2024 (LD Munich) order of 5 November 2024.pdf | 2025-07-09 | Not public |
| Exhibit TW 8.10 UPC_CFI_148-2024 (LD Munich) Order of 27 June 2025.pdf | 2025-07-09 | Not public |
| Exhibit TW 8.12 Accord s Rejoinder to the Sanofi s comments on the Preliminary Objections - filed 11 October 2024.pdf | 2025-07-09 | Not public |
| Exhibit TW 8.11 Accord s Preliminary Objections and Generic Procedural Application - filed 1 July 2024.pdf | 2025-07-09 | Not public |
| Exhibit TW 6.5 Schedule of costs for the Defendants as of 8 July 2025 (signed).pdf | 2025-07-09 | Not public |
| Exhibit TW 8.8 UPC_CFI_145-2024 (LD Munich) Order of 27 February 2025.pdf | 2025-07-09 | Not public |
| Exhibit TW 6.4 Sanofi Winthrop Industries annuals report for the period 2020 2025.pdf | 2025-07-09 | Not public |
| Exhibit TW 6.4 Sanofi Winthrop Industries annuals report for the period 2020 2025.pdf | 2025-07-09 | Not public |
| Exhibit TW 8.1 UPC_CFI_145-2024 (LD Munich) orders of 1st October 2024.pdf | 2025-07-09 | Not public |
| Exhibit TW 5.35bis Sanofi Annual Report 20-F 2008 in the US (complete version).pdf | 2025-07-09 | Not public |
| Exhibit TW 8.4 UPC_CFI_145-2024 (LD Munich) order of 3 January 2025.pdf | 2025-07-09 | Not public |
| Exhibit TW 8.13 Accord Comments on 262A Sanofi s request - filed on 12 November 2024.pdf | 2025-07-09 | Not public |
| Exhibit TW 8.7 UPC_CFI_145-2024 (LD Munich) order of 22 January 2025.pdf | 2025-07-09 | Not public |
| Exhibit TW 8.15 Official communication 3 March 2025 from Accord UPC representatives to Sanofi UPC representatives.pdf | 2025-07-09 | Not public |
| Exhibit TW 8.9 UPC_CFI_145-2024 (LD Munich) Order of 8 May 2025 REDACTED version.pdf | 2025-07-09 | Not public |
| Exhibit TW 7.2 Extracts W Tilmann and C Plasmann Unified Patent Protection in Europe A Commentary book 1st Ed published | 2025-07-09 | Not public |
| Exhibit TW 8.3 UPC_CFI_145-2024 (LD Munich) order of 19 December 2024.pdf | 2025-07-09 | Not public |
| Exhibit TW 8.5 UPC_CFI_145-2024 (LD Munich) order of 9 January 2025.pdf | 2025-07-09 | Not public |
| Exhibit TW 8.6 UPC_CFI_145-2024 (LD Munich) order of 14 January 2025.pdf | 2025-07-09 | Not public |
| ACT_16112-2024 and 4499-2024 Accord Reply to the Defence to the Counterclaim and Rejoinder UNREDACTED version 8 July 202 | 2025-07-09 | Not public |
| ACT_16112-2024 and 4499-2024 Accord Reply to the Defence to the Counterclaim and Rejoinder UNREDACTED version 8 July 202 | 2025-07-09 | Not public |
| Exhibit TW 8.14 Accord Comments on Sanofi amended requests and Rejoinder to Sanofi comments - filed on 12 February 2025. | 2025-07-09 | Not public |
| Exhibit TW 6.3 - Paris Court Judgment issued on 6 September 2024 Accord v Sanofi RG 21-06416.pdf | 2025-07-09 | Not public |
| Application-RoP293-Receipt | 2025-07-08 | Not public |
| Formal-checks_Notification-of-positive-outcome | 2025-07-08 | Not public |
| Application-RoP293 | 2025-06-27 | Not public |
| Application | 2025-06-27 | Not public |
| Acknowledgement-of-change-of-a-representative | 2025-05-23 | Not public |
| Acknowledgement-of-change-of-a-representative | 2025-05-23 | Not public |
| Acknowledgement-of-change-of-a-representative | 2025-05-23 | Not public |
| Acknowledgement-of-change-of-a-representative | 2025-05-23 | Not public |
| Acknowledgement-of-change-of-a-representative | 2025-05-23 | Not public |
| Acknowledgement-of-change-of-a-representative | 2025-05-23 | Not public |
| Acknowledgement-of-change-of-a-representative | 2025-05-23 | Not public |
| Acknowledgement-of-change-of-a-representative | 2025-05-22 | Not public |
| Application-RoP293-Receipt | 2025-05-22 | Not public |
| Formal-checks_Notification-of-positive-outcome | 2025-05-22 | Not public |
| Application-RoP293-Receipt | 2025-05-22 | Not public |
| Formal-checks_Notification-of-positive-outcome | 2025-05-22 | Not public |
| Application-RoP293-Receipt | 2025-05-22 | Not public |
| Formal-checks_Notification-of-positive-outcome | 2025-05-22 | Not public |
| Application-RoP293-Receipt | 2025-05-22 | Not public |
| Formal-checks_Notification-of-positive-outcome | 2025-05-22 | Not public |
| Application-RoP293-Receipt | 2025-05-22 | Not public |
| Formal-checks_Notification-of-positive-outcome | 2025-05-22 | Not public |
| Application-RoP293-Receipt | 2025-05-22 | Not public |
| Formal-checks_Notification-of-positive-outcome | 2025-05-22 | Not public |
| Application-RoP293-Receipt | 2025-05-22 | Not public |
| Formal-checks_Notification-of-positive-outcome | 2025-05-22 | Not public |
| Application-RoP293 | 2025-05-22 | Not public |
| Application - Change of Representative - Jules Fabre Signed 20250519.pdf | 2025-05-22 | Not public |
| Application-RoP293 | 2025-05-22 | Not public |
| Application - Change of Representative - Jules Fabre Signed 20250519.pdf | 2025-05-22 | Not public |
| Application-RoP293 | 2025-05-22 | Not public |
| Application - Change of Representative - Jules Fabre Signed 20250519.pdf | 2025-05-22 | Not public |
| Application-RoP293 | 2025-05-22 | Not public |
| Application - Change of Representative - Jules Fabre Signed 20250519.pdf | 2025-05-22 | Not public |
| Application-RoP293 | 2025-05-22 | Not public |
| Application - Change of Representative - Jules Fabre Signed 20250519.pdf | 2025-05-22 | Not public |
| Application-RoP293 | 2025-05-22 | Not public |
| Application - Change of Representative - Jules Fabre Signed 20250519.pdf | 2025-05-22 | Not public |
| Application-RoP293 | 2025-05-22 | Not public |
| Application - Change of Representative - Jules Fabre Signed 20250519.pdf | 2025-05-22 | Not public |
| Application-RoP293-Receipt | 2025-05-21 | Not public |
| Formal-checks_Notification-of-positive-outcome | 2025-05-21 | Not public |
| Application-RoP293 | 2025-05-19 | Not public |
| Application Change of Representative | 2025-05-19 | 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 |
| Hearing Reference | 2025-01-16 | Not public |
| Hearing-Dates | 2025-01-13 | Not public |
| R 305 second- oral comments | 2025-01-13 | Not public |
| Receipt | 2025-01-09 | Not public |
| Application | 2025-01-09 | Not public |
| Exhibit No. A.02.2 | 2025-01-09 | Not public |
| Outcome of the Order | 2024-12-19 | Not public |
| extension request | 2024-12-19 | Public |
| Receipt | 2024-12-10 | Not public |
| 2024 12 09 - Accord - Request for extension of deadline | 2024-12-09 | Not public |
| Acknowledgement-of-lodging | 2024-12-05 | Not public |
| 2024 12 05 - Application to change details of a representative 64597- 2024 | 2024-12-05 | Not public |
| 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 |
| epoUploadDocumentsWorkflow | 2024-09-17 | Not public |
| Document from EPO | 2024-09-16 | Not public |
| Acknowledgement of access to case | 2024-09-06 | Not public |
| Notification Of Service | 2024-09-06 | Not public |
| Panel-Appointment | 2024-09-06 | Not public |
| EPO-Request-for-case-pending | 2024-09-06 | Not public |
| Acknowledgement-of-lodging | 2024-09-06 | Not public |
| Formal-checks_Notification-of-positive-outcome | 2024-09-04 | Not public |
| Exhibit PM 5.23 Wayback machine extracts from ClinicalTrial.gov. 2008 and 2009 | 2024-08-30 | Not public |
| Exhibit PM 2.7 Revue Prescrire Cabazitaxel Jevtana Trop toxique pour une efficacite trop incertaine October 2011 | 2024-08-30 | Not public |
| Exhibit PM 2.5 Refusal notice issued by the INESSS in February 2015 | 2024-08-30 | Not public |
| Exhibit PM 5.30 Screenshot from OpenPaymentsData.CMS.gov | 2024-08-30 | Not public |
| Exhibit PM 5.20 Beardsley et al. Systemic therapy after first-line docetaxel (...) 2008 | 2024-08-30 | Not public |
| Exhibit PM 2.4 Le Monde Sanofi Londres refuse de rembourser le Jevtana of 13 January 2012 | 2024-08-30 | Not public |
| Exhibit PM 2.1 Summary of product characteristics of Jevtana | 2024-08-30 | Not public |
| Exhibit PM 2.7 Revue Prescrire Cabazitaxel Jevtana Trop toxique pour une efficacite trop incertaine October 2011 | 2024-08-30 | Not public |
| Exhibit PM 6.1 Excerpts IQVIA Audit Data Presentation July 2024 | 2024-08-30 | Not public |
| Exhibit PM 5.26 Correspondence in The Lancet (2011) re PM 5.25 Froehner and Wirth v. De Bono | 2024-08-30 | Not public |
| Exhibit PM 1.1 French company registry extract for Sanofi Mature IP | 2024-08-30 | Not public |
| Exhibit PM 2.6 Opinion of the Transparency Committee of the French National Health Authority 17 October 2012 | 2024-08-30 | Not public |
| Exhibit PM 5.16 Oudard et al. Multicenter randomized phase II study (...) May 2005 | 2024-08-30 | Not public |
| Exhibit PM 1.3 Communication from the Paris Court of First Instance dated 5 July 2024 | 2024-08-30 | Not public |
| Exhibit PM 4.11 Notice of appeal Accord of 15 January 2024 | 2024-08-30 | Not public |
| Exhibit PM 5.33 Extracts from Sanofi Annual Report 2008 | 2024-08-30 | Not public |
| Exhibit PM 5.5 US 2005 065138 A1 | 2024-08-30 | Not public |
| Exhibit PM 5.2 Annexes to the declaration by Dr Samuel Denmaede (part 3) | 2024-08-30 | Not public |
| Exhibit PM 4.7 Record of the assignment of EP 466 during its examination before the EPO | 2024-08-30 | Not public |
| Exhibit PM 5.19 Pivot et al. A multicenter phase II study of XRP6258 (...) 2008 | 2024-08-30 | Not public |
| Exhibit PM 5.3 Declaration by Dr. Kurt Miller | 2024-08-30 | Not public |
| 44999-2024 proof of Court fees payment | 2024-08-30 | Not public |
| Exhibit PM 4.12 Grounds of appeal Accord of 24 May 2024 | 2024-08-30 | Not public |
| Exhibit PM 5.9 ICH Topic E8 Note for guidance on general considerations for clinical trials March 1998 | 2024-08-30 | Not public |
| Exhibit PM 5.2 Annexes to the declaration by Dr Samuel Denmaede (part 4) | 2024-08-30 | Not public |
| Exhibit PM 5.2 Annexes to the declaration by Dr. Samuel Denmaede (part 1) | 2024-08-30 | Not public |
| Exhibit PM 4.8 Notice of opposition Accord of 10 March 2021 | 2024-08-30 | Not public |
| Exhibit PM 5.15 Petrylak et al. Docetaxel and estramustine compared (...) 2004 Oct. | 2024-08-30 | Not public |
| Exhibit PM 5.28 Declaration by Dr. Sartor before the Patent and trial and appeal board 20 April 2017 | 2024-08-30 | Not public |
| Exhibit PM 5.7 Tannock et al. Docetaxel plus prednisone or mitoxantrone plus prednisone (...) 2004 Oct. | 2024-08-30 | Not public |
| Exhibit PM 1.1 French company registry extract for Sanofi Mature IP | 2024-08-30 | Not public |
| Exhibit PM 5.35 Extracts Sanofi Annual report 20-F 2008 in the US | 2024-08-30 | Not public |
| Exhibit PM 5.10 CHMP guideline on the evaluation of anticancer medicinal products in man December 2005 | 2024-08-30 | Not public |
| Exhibit PM 5.2 Annexes to the declaration by Dr. Samuel Denmaede (part 2) | 2024-08-30 | Not public |
| Exhibit PM 5.29 Extracts from Dr. Sartor deposition transcript of 8 May 2017 in the US proceedings | 2024-08-30 | Not public |
| Exhibit PM 2.4 Le Monde Sanofi Londres refuse de rembourser le Jevtana of 13 January 2012 | 2024-08-30 | Not public |
| Exhibit PM 2.3 Opinion of the Transparency Committee of the French National Health Authority of 19 October 2011 | 2024-08-30 | Not public |
| Exhibit PM 5.32 Madan et al. Overcoming Chemotherapy Resistance in Prostate Cancer (...) June 2011 | 2024-08-30 | Not public |
| Exhibit PM 4.2 WO 2011 051894 A1 | 2024-08-30 | Not public |
| Exhibit PM 5.6 Extracts from the Summary of Product Characteristics of Taxotere | 2024-08-30 | Not public |
| Exhibit PM 5.36 Galletti et al. Paclitaxel and Docetaxel Resistance (...) 2007 | 2024-08-30 | Not public |
| Exhibit PM 1.2 Extract Sanofi annual reports | 2024-08-30 | Not public |
| Exhibit PM 5.4 Declaration by Prof. Stefan Muller | 2024-08-30 | Not public |
| Exhibit PM 4.10 Opposition Division reasoned decision dated on 25 January 2024 | 2024-08-30 | Not public |
| Exhibit PM 1.3 Communication from the Paris Court of First Instance dated 5 July 2024 | 2024-08-30 | Not public |
| Exhibit PM 5.24 Screenshot from ClinicalTrial.gov XRP6258 Plus Prednisone Compared to (...) 3 May 2021 | 2024-08-30 | Not public |
| Exhibit PM 5.25 De Bono et al. Prednisone plus cabazitaxel or mitoxantrone (...) The Lancet 2010 | 2024-08-30 | Not public |
| Exhibit PM 5.13 Scher et al. Design and end points of clinical trials for patients (...) 2008 | 2024-08-30 | Not public |
| Exhibit PM 5.22 Sanofi press release dated 21 December 2009 | 2024-08-30 | Not public |
| Exhibit PM 5.21 TROPIC trial protocol in a document entitled Cabazitaxel (XRP-6258) for hormone (...) 2009 | 2024-08-30 | Not public |
| Exhibit PM 2.2 Neutropenia MSD Manual | 2024-08-30 | Not public |
| Exhibit PM 5.18 Mita et al. Phase I and pharmacokinetic study of XRP6258 (...) 2009 | 2024-08-30 | Not public |
| ACT_16112-2024 and 4499-2024_Accord_Statement of Defence and Counterclaim for Revocation_30 August 2024 | 2024-08-30 | Not public |
| Exhibit PM 5.8 Tannock et al. Chemotherapy with mitoxantrone plus prednisone (...)1996 Jun. | 2024-08-30 | Not public |
| Exhibit PM 4.5 Extracts from the European Patent register for EP 2 493 466 as at 21 August 2024 | 2024-08-30 | Not public |
| Exhibit PM 5.14 Label Novantrone (Mitoxantrone) FDA | 2024-08-30 | Not public |
| Exhibit PM 3.1 Summary of product characteristics of Cabazitaxel Accord | 2024-08-30 | Not public |
| Exhibit PM 4.6 Summons to oral proceedings by the Board of Appeal and date confirmation | 2024-08-30 | Not public |
| Exhibit PM 5.12 Declaration of Helsinki Ethical Principles of Medical Research involving Human Subjects October 2008 | 2024-08-30 | Not public |
| Exhibit PM 6.2 Order 7 June 2022 First Instance Court | 2024-08-30 | Not public |
| Exhibit PM 7.1 Extract Paul England A practioners Guide to the UPC and UP Dec 2022 | 2024-08-30 | Not public |
| Exhibit PM 5.11 Wong and Siah Estimation of clinical trial success rates and related parameters Biostatistics 2019 | 2024-08-30 | Not public |
| Exhibit PM 5.17 Berthold et al. Survival and PSA response of patients in the TAX 327 study | 2024-08-30 | Not public |
| Exhibit PM 5.34 Fitzpatrick et al. Treatment Decisions for Advanced Genitourinary (...) 2009 | 2024-08-30 | Not public |
| Exhibit PM 5.31 Kumar Pal et al. Critical appraisal of cabazitaxel (...) Clinical Interventions in Aging 2010 | 2024-08-30 | Not public |
| Exhibit PM 4.13 Decision of the United States Patent Office (USPTO) of 22 October 2019 | 2024-08-30 | Not public |
| Exhibit PM 2.5 Refusal notice issued by the INESSS in February 2015 | 2024-08-30 | Not public |
| Exhibit PM 4.3 Priority document No. US 61 256 160 (P1) | 2024-08-30 | Not public |
| Exhibit PM 4.14 IP.appify Blog of 12 janvier 2024 Caselaw-EPO-reviews of EPO BoA decisions of D.X. Thomas | 2024-08-30 | Not public |
| Exhibit PM 4.1 EP E 493 466 B1 | 2024-08-30 | Not public |
| Exhibit PM 2.8 Sales of Jevtana in European countries in 2020 (based on IQVIA data) | 2024-08-30 | Not public |
| Exhibit PM 4.4 Priority document No. US 61 293 903 (P2) | 2024-08-30 | Not public |
| Exhibit PM 5.1 Declaration by Dr. Samuel Denmeade | 2024-08-30 | Not public |
| Exhibit PM 5.27 Declaration by Dr. Sartor of 23 December 2020 | 2024-08-30 | Not public |
| Exhibit PM 4.9 Further observations Accord of 10 December 2021 | 2024-08-30 | Not public |
| Exhibit PM 6.2 Order 7 June 2022 First Instance Court | 2024-08-30 | Not public |