UPC_CFI_145/2024 - UPC_CFI_463/2024 – Sanofi v Accord/Stada/Reddy/Zentiva

Expert Commentary

Second interim conference Facts Points raised during second interim conference: 1. The Board of Appeal (“BoA”) of the European Patent Office (“EPO”) had not yet uploaded the written reasoned decision following the oral hearing of 2-4 June 2025. According to a BoA communication, the parties could expect the written decision by 15 September 2025 or the end of September. The Court decides that the parties have until 8 October 2025 to comment on the decision. 2. The claimant informs that an appeal has been filed against the French nullity decision. An oral hearing is scheduled for 18 June 2026. 3. The experts (2) will be heard on the basis of their written submissions and will be answering 10 detailed questions formulated by the JR. Such questions mainly relate to the issue whether the skilled person thinks there is a reasonable chance of success if the third phase oncological studies have been approved and have been ongoing for three years without premature interruption. 4. The JR sets a detailed agenda for a three-day hearing. (There are four different generic companies and each has its own representative.) 5. A late filed declaration by Zentiva is refused as the request to file further evidence could have been filed earlier. 6. JR confirms the value of the litigation as set out in the order of 22 January 2024. 7. Parties are again suggested to conclude an agreement on costs. Comment 1. The BoA decided on 4 June 2025 to uphold the patent (for a new treatment of prostate cancer). Why is there no written decision after more than 3,5 months while the BoA has been informed about the pending litigation? It all shows that the UPC should be very conservative in granting stays because of a pending opposition. This is also what the Rules of Procedure reflect. 2. In this case the oral hearing is scheduled for 14-17 October 2025. The BoA promised to issue its written decision by the end of September. Let us hope for the parties and the Court that they keep their promise! 3. Note that in France, the hearing date before the Appeal Court is only scheduled for 18 June 2026. So the Munich Local Division has (also) to decide for France (assuming Sanofi included that in their claim) before the fate of the French EP is known, all also assuming that the nullity case in France is not between the same parties. If that is indeed not the case, the Munich Local Division can stay the case for France or make its decision for France conditional on the outcome of the French appeal, if it considers the patent valid and infringed. 4. The JR again asks the parties to agree on costs. It is hoped that the representatives will now indeed follow the request of the JR. I noticed that generally representatives from most UPC countries do not have experience with agreeing on costs. It would be good if a conference organizer (or EPLAW together with EPLIT?) would organize a conference about costs in the UPC and how to reach agreement on costs. Far too much of the Court’s time and clients’ money is spent on costs, while for most (normal) patent practitioners it is also not their favorite subject! 5. In the same case, the JR issued also on 15 September 2025 a procedural order for summoning the experts to the oral hearing (see here).

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 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. 7) Accord Healthcare, Unipessoal Lda. 8) Accord Healthcare AB represented by: Jules Fabre (Taylor Wessing) 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 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. LANGUAGE OF THE PROCEEDINGS English SUBJECT-MATTER OF THE PROCEEDINGS R.105.5 RoP following the second interim conference of 12 September 2025. 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 POINTS RAISED DURING THE SECOND INTERIM CONFERENCE 1) EPO BoA The EPO BoA has not yet uploaded the written reasoned decision following the oral hearing on 2–4 June 2025, at which the patent was upheld. The BoA has communicated the following possible upload dates: 15 September 2025 or the end of September. Parties may comment on the written reasons provided by the EPO BoA by 8 October 2025 at the latest. This deadline is independent of the date on which the written reasons are served to the parties. If service occurs after 8 October 2025, parties may comment on it during the oral hearing. 2) Frech First Instance Nullity Decision Sanofi explains that the French first-instance decisions that invalidated the French part of the European patent are under appeal. The appeal court has scheduled an oral hearing for 18 June 2026. 3) Expert Testimony Expert testimony from two party experts. JR confirms that they will be heard as requested by Sanofi and the four defendants. This will be based on their written submissions, as follows: Dr Exhibit B26 (Sanofi). Dr 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? 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 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? 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 years without premature interruption? During the interim conference, the defendants expressed concerns about these questions, stating that legal questions should not be answered by experts. The panel is aware of the distinction between legal and factual questions. Hearing the two experts will enable the panel to answer the legal question of obviousness. Subject to R. 178.5 RoP, parties may put their own questions to the experts after the panel. 4) Dr. (Sanofi) 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. Dr will be invited via email. 5) Dr. (Accord, Reddy, Stada, Zentiva) Dr 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. Dr will be invited by email. 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 6) Schedule, structure, format and scope for oral hearing 14-17 October 2025; coordination of the defendant`s oral submissions The following schedule will be followed for the oral hearing: Tuesday, 14 October 2025 9.00-10.00 Introduction by the Presiding Judge 10.00-10.30 Break 10.30-11.30 Oral submissions by defendants on validity (lack of inventive step – Tropic Study) 11.30-11.45 Break 11.45-12.45 Oral submissions by claimant on validity (lack of inventive step – Tropic Study) 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 15.00-17.00 Infringement Stada Thursday, 16 October 2025 9.00-10.30 Infringement Accord 10.30-11.00 Break 11.00-12.30 Infringement Zentiva 12.30-14.00 Break 14.00-15.30 Infringement Reddy Friday, 17 October 2025 [Possible continuation of the oral hearing] This schedule may be subject to amendment. 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 The four counterclaims will be heard together. The four infringement actions, however, will be heard separately. UPC representatives for the defendants are encouraged to coordinate their oral submissions for the joint counterclaim hearings. 7) Seating plan for oral hearing; additional VC possible A seating plan for Hearing Room 212 has been emailed to the relevant parties. This plan only applies to joint hearings. Spare chairs are reserved for members of the public. Additional participants from the parties are invited to follow the hearing in either overflow room 220b or one of the breakout rooms via the parallel video conference. The draft plan communicated earlier has been amended to accommodate comments made by the parties during the second interim conference. There will be a parallel video conference. 8) Sanofi v. Zentiva Zentiva requests that the following documents be admitted into the proceedings: - DFMP D116 (Dr declaration); and - DFMP D117 (Prof second affidavit, dated 8 August 2025). Sanofi requests that exhibit DFMP D117 be dismissed as inadmissible. The rules that DFMP D117 was filed late and will be disregarded. However, DFMP D116 (Dr declaration), is admitted. Zentiva explained that the second submission by Prof. had been prompted by the first interim conference. Therefore, an application to file further evidence could have been made earlier. 9) Accord v. Sanofi Accord expressed the need for clarification regarding the requests on which Sanofi intends to rely. The other defendants agreed. Sanofi explained that the still-relevant requests had been filed with the 20 March 2025 brief. 10) Value in dispute – agreement on lump sum reimbursement of costs? JR confirms the values set out in the order of 22 January 2024. Once again, the JR suggests that the parties conclude an agreement on a lump sum payment for cost reimbursement prior to the date of the oral hearing. 11) Housekeeping Parties are asked to submit a list of participating individuals (in person (212, 220b, breakout- room, VC)) by email no later than 8 October 2025. 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 ORDER 1. The dates of the oral hearing are confirmed as 14–17 October 2025 at 09:00. The oral hearing on Wednesday will start one hour later. 2. The four counterclaims will be heard together; each of the four infringement actions will be heard separately. 3. All parties are summoned for all four days. As discussed at the interim conference, the schedule may be amended. The oral hearing may end on Wednesday morning or continue until Friday. 4. Parties are asked to submit a list of individuals participating in person (rooms 212 and 220b, breakout rooms, VC) by email no later than 8 October 2025. 5. Dr and Dr are invited to testify as party experts on 14 October 2025 at 2:00 pm and possibly on 15 October 2025 at 10:00 am, in person in Munich. Dr will testify on behalf of Sanofi and Dr on behalf of all four defendants. The two experts will be summoned by email. 6. The late submission of Dr declaration is permitted for Zentiva. 7. Zentiva's late submission of the second affidavit by Prof. dated 8 August 2025 (DFMP D117), is rejected. This exhibit will not be considered by the panel. 8. Parties may comment on the EPO BoA's written reasons in writing by no later than 8 October 2025. 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). INFORMATION ABOUT ORAL HEARING HELD IN COURT The oral hearing shall be open to the public unless the Court decides to make it, to the extent necessary, confidential in the interests of one or both parties or third parties or in the general interest of justice or public order (R. 115 RoP). INFORMATION ABOUT AUDIO RECORDING The oral hearing shall be audio recorded. The recording shall be made available at the premises of the Court to the parties or their representatives after the oral hearing (R. 115 RoP). INFORMATION ABOUT ABSENCE OR DELAY OF A REPRESENTATIVE A decision by default may be given, upon request, against a party that was duly summoned but fails to appear at the oral hearing (R. 355.1 (b) RoP. 7 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 INFORMATION ABOUT DECISION BY DEFAULT Should a party fail to comply with the present Order within the time period specified, a decision by default may be given in accordance with R. 355 RoP (R. 103.1, last subparagraph and .2 RoP). Matthias Digital unterschrieben von Matthias ZIGANN ZIGANN Datum: 2025.09.15 11:37:53 +02'00' Dr. Zigann Presiding Judge 8 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_69479/2024 in ACTION NUMBER: ACT_16112/2024 UPC number: UPC_CFI_145/2024 Action type: Infringement Action Order no. ORD_69480/2024 in ACTION NUMBER: ACT_16116/2024 UPC number: UPC_CFI_146/2024 Action type: Infringement Action Order no. ORD_69481/2024 in ACTION NUMBER: ACT_16119/2024 UPC number: UPC_CFI_147/2024 Action type: Infringement Action Order no. ORD_69482/2024 in ACTION NUMBER: ACT_16120/2024 UPC number: UPC_CFI_148/2024 Action type: Infringement Action 9

Key Holdings

• Deadline set for comments on pending EPO BoA decision.
• Expert questioning at hearing limited to JR's 10 detailed questions.
• Late evidence from Zentiva refused.
• Costs agreement encouraged again.

Tags

• Case Management
• Expert Evidence
• Interim Measures
• Late Submissions
• Opposition Proceedings

Related Cases

• UPC_CFI_743/2025 – Skechers v Fast IP
• UPC_CFI_804/2025 – TP Link (USA) v Huawei (China)
• UPC_CFI_119/2025; UPC_CFI_401/2025 – Shanghai v Longi
• UPC CFI 425/2024, UPC CFI 751/2024 – JingAo Solar Co., Ltd. v Chint New Energy Technology Co., Ltd. et al.
• UPC_CFI_771/2025; UPC_CFI_802/2025 – Solvay v Zhejiang