UPC_CFI_145/2024 - UPC_CFI_463/2024 - Experts – Sanofi v Accord/Stada/Reddy/Zentiva (Expert Summons)
- Court
- Local Division Munich
- Date
- Outcome
- Granted
- Sector
- Other
- Decision Type
- PROCEDURAL
Expert Commentary
Procedural order for summoning experts Facts The JR issued a procedural order for summoning the experts to the oral hearing.
Full Decision Text
Local Division Munich UPC_CFI_145/2024 - UPC_CFI_463/2024 UPC_CFI_146/2024 - UPC_CFI_496/2024 UPC_CFI_147/2024 - UPC_CFI_374/2024 UPC_CFI_148/2024 - UPC_CFI_503/2024 Summons of party experts to the oral hearing Procedural Order of the Court of First Instance of the Unified Patent Court Local Division Munich issued on 15 September 2025 CLAIMANTS 1) Sanofi SA as successor of Sanofi Mature IP 2) Sanofi Winthrop Industrie 3) Sanofi Winthrop Industrie as successor of Sanofi-Aventis France (not a party in UPC_CFI 145/2024) 4) Sanofi-Aventis GmbH 5) Sanofi Belgium 6) Sanofi-Aventis Deutschland GmbH 7) Sanofi S.r.l. 8) Sanofi B.V. 9) Sanofi - Produtos Farmaceuticos Lda 10) Sanofi AB 11) Sanofi A/S represented by: Frédéric Chevallier (McDermott Will & Emery). DEFENDANTS – UPC_CFI_145/2024 - UPC_CFI_463/2024 1) Accord Healthcare S.L.U. 2) Accord Healthcare GmbH (AT) 3) Accord Healthcare BV 4) Accord Healthcare GmbH (DE) 5) Accord Healthcare Italia Srl 6) Accord Healthcare B.V. UPC_CFI_145/2024 - UPC_CFI_463/2024 UPC_CFI_146/2024 - UPC_CFI_496/2024 UPC_CFI_147/2024 - UPC_CFI_374/2024 UPC_CFI_148/2024 - UPC_CFI_503/2024 7) Accord Healthcare, Unipessoal Lda. 8) Accord Healthcare AB represented by: Jules Fabre (Taylor Wessing) DEFENDANTS – UPC_CFI_146/2024 - UPC_CFI_496/2024 1) STADAPHARM GmbH 2) STADA Arzneimittel AG 3) STADA Nordic ApS represented by: Daniel Hoppe (Bonabry). DEFENDANTS – UPC_CFI_147/2024 - UPC_CFI_374/2024 1) Reddy Pharma SAS 2) betapharm Arzneimittel GmbH 3) Dr Reddy's Srl represented by: Dr. Christian Meyer (Maiwald). DEFENDANTS – UPC_CFI_148/2024 - UPC_CFI_503/2024 1) Zentiva France 2) Zentiva Pharma GmbH 3) Zentiva, k.s. represented by: Dr. Anja Lunze (Taylor Wessing). PATENT AT ISSUE European patent n° 2 493 466 PANEL/DIVISION Panel 1 of the Local Division Munich DECIDING JUDGE/S This order has been issued by Presiding Judge Dr. Matthias Zigann acting as judge-rapporteur. 2 UPC_CFI_145/2024 - UPC_CFI_463/2024 UPC_CFI_146/2024 - UPC_CFI_496/2024 UPC_CFI_147/2024 - UPC_CFI_374/2024 UPC_CFI_148/2024 - UPC_CFI_503/2024 LANGUAGE OF THE PROCEEDINGS English SUBJECT-MATTER OF THE PROCEEDINGS Summons of party experts to the oral hearing GROUNDS In an order dated 15 September 2025, the judge rapporteur confirmed that the expert testimony of two party experts would be heard, as requested by Sanofi and the four defendants. This will be based on their written submissions: Exhibit B26 (Sanofi). Exhibits PM 5.1 and 5.2 (Accord); D54 and PBP1 (Stada); DFMP D116 (Zentiva); and MWCC 22 (Reddy). The experts may use written notes and shall answer the main question: 'What information would a person working in the industry at the priority date have derived from the Phase III TROPIC study and the time that has passed since it started? Was there a reasonable expectation of success?' broken down into the following more detailed questions: a) What are the respective aims of oncological clinical trials of phase I, II and III? Is there a difference to clinical trials with non-oncological drugs? b) What circumstantial data is needed to support an oncological phase III trial getting started? c) Can a phase II study be omitted? If so, what data would support a phase I/III transition? d) Clinical phase III trials are evaluated by the Data Safety Monitoring Board (DSMB). What is the role of DSMB during the study? When will the DSMB intervene? e) Is a phase III trial discontinued or not authorized by the EMA if the investigated drug is not superior in efficacy to the comparator? f) What is the success rate in oncological phase III trials in general? g) What is the success rate in oncological phase III trials with the comparator mitoxantrone/prednisone? 3 UPC_CFI_145/2024 - UPC_CFI_463/2024 UPC_CFI_146/2024 - UPC_CFI_496/2024 UPC_CFI_147/2024 - UPC_CFI_374/2024 UPC_CFI_148/2024 - UPC_CFI_503/2024 h) In the present case the TROPIC trial is not supported by a phase II trial with the same patient group. Is this uncommon in the field of oncology, respectively in the field of taxanes? i) What kind of indicative data was needed to support the start of the phase III study TROPIC? j) Did the skilled person have reason to expect the TROPIC study to be successful, given that the skilled person knew the study had been approved and had been ongoing for three hyears without premature interruption? Regarding (Sanofi) Adress: Divisions of Human Biology and Clinical Research Program in Prostate Cancer Research Phone: Fax: Email: Sanofi has deposited an amount for the fees. An additional amount for travel costs will be paid by Sanofi directly. If successful, Sanofi will ask the defendants for reimbursement. will be invited via email. Regarding (Accord, Reddy, Stada, Zentiva) Adress: Professor of Oncology Director Genitourinary Oncology Email: will waive his entitlement to costs and fees against the court and will instead be reimbursed directly by Accord. The other defendants will reimburse Accord in proportion to their respective shares. If successful, the defendants will ask Sanofi for reimbursement. 4 UPC_CFI_145/2024 - UPC_CFI_463/2024 UPC_CFI_146/2024 - UPC_CFI_496/2024 UPC_CFI_147/2024 - UPC_CFI_374/2024 UPC_CFI_148/2024 - UPC_CFI_503/2024 will be invited by email. The schedule, structure, format and scope for oral hearing 14-17 October 2025 The following schedule will be followed for the oral hearing as far as the party experts are concerned: Tuesday, 14 October 2025 12.45-14.00 Break 14.00-16.00 Questions by the panel to the two experts 16.00-16.30 Break 16.30-18.30 Questions by the parties to the two experts and pleadings by the parties (lack of inventive step – Tropic Study – after having heard the two experts) Wednesday, 15 October 2025 10.00-10.15 A panel announcement regarding whether the proceedings will continue or end. 10.15-11.15 Oral submission by defendants on validity (rest) – and/or possible additional hearing of experts 11.15-12.15 Oral submission by claimant on validity (rest) - and/or possible additional hearing of experts 12.15-13.30 Break 13.30-14.30 Morning session continued 14.30-15.00 Break ORDER 1. It is ordered that the party experts and are summoned to the oral hearing which shall take place on 14 October 2025 at 2:00 pm and possibly on 15 October 2025 at 10:00 am, at Local Division Munich, Denisstr. 3 in Munich, hearing room 212. 2. The party experts shall be informed of the following: a. the testimony of the expert(s) may be heard by the Court, in particular on the facts set out above [R. 177.2(c), 181.1 RoP]. b. the expert(s) may be questioned by the Court and the parties [R. 177.2(e), 181.1 RoP]. c. the language of the proceedings is English. [R. 177.2(f), 181.1 RoP]. d. the party expert(s) shall be informed of their duties [R. 177.3, 181.1 RoP]: 5 UPC_CFI_145/2024 - UPC_CFI_463/2024 UPC_CFI_146/2024 - UPC_CFI_496/2024 UPC_CFI_147/2024 - UPC_CFI_374/2024 UPC_CFI_148/2024 - UPC_CFI_503/2024 aa) to obey the summons and attend the hearing [R. 179.1, 181.1 RoP] bb) to give evidence [R. 178.2, 181.1 RoP] to assist the Court impartially on matters relevant to his area of expertise [R. 181.2(a) RoP cc) to be independent and objective and not to act as an advocate for any party to the proceedings [R. 181.2(b) RoP 3. The court summons the party experts via email. 4. As explained above, reimbursement claims against the Court are limited or excluded. 5. The two party experts must contact the court immediately if anything gives them cause for concern. INFORMATION ABOUT REVIEW BY THE PANEL Any party may request that this Order be referred to the panel for a review pursuant to R. 333 RoP. Pending review, the Order shall be effective (R. 102.2 RoP). Matthias Digital unterschrieben von Matthias ZIGANN ZIGANN 16:17:21 +02'00' Datum: 2025.09.15 Dr. Zigann Presiding Judge 6 UPC_CFI_145/2024 - UPC_CFI_463/2024 UPC_CFI_146/2024 - UPC_CFI_496/2024 UPC_CFI_147/2024 - UPC_CFI_374/2024 UPC_CFI_148/2024 - UPC_CFI_503/2024 DETAILS OF THE ORDER Order no. ORD_69488/2024 in ACTION NUMBER: ACT_16112/2024 UPC number: UPC_CFI_145/2024 Action type: Infringement Action Order no. ORD_69489/2024 in ACTION NUMBER: ACT_16116/2024 UPC number: UPC_CFI_146/2024 Action type: Infringement Action Order no. ORD_69490/2024 in ACTION NUMBER: ACT_16119/2024 UPC number: UPC_CFI_147/2024 Action type: Infringement Action Order no. ORD_69487/2024 in ACTION NUMBER: ACT_16120/2024 UPC number: UPC_CFI_148/2024 Action type: Infringement Action 7
Key Holdings
- Experts summoned to oral hearing.
Tags
- Expert Evidence
- Oral Hearing