Short Summary
Procedural order issued by the Local Division Munich of the Unified Patent Court following an interim conference in patent infringement actions concerning European patent EP 2 493 466. The order addresses pending issues including the awaited written reasoned decision from the EPO Board of Appeal (which upheld the patent at an oral hearing in June 2025), ongoing French appeal proceedings regarding invalidation of the French part of the patent, and preparations for the oral hearing scheduled for October 2025. The court confirmed dates for the final interim conference and oral hearing, and addressed procedural matters including confidentiality of interim damages calculations and the format of Sanofi's briefs.
Detailed Summary
This is a Procedural Order (ORD_22245/2025 and related orders) issued on 17 July 2025 by Presiding Judge Dr. Matthias Zigann of the Local Division Munich of the Unified Patent Court, following an interim conference held on the same date.
The proceedings involve multiple Sanofi claimants (including Sanofi SA as successor of Sanofi Mature IP, Sanofi Winthrop Industrie, Sanofi-Aventis GmbH, Sanofi Belgium, Sanofi-Aventis Deutschland GmbH, Sanofi S.r.l., Sanofi B.V., Sanofi - Produtos Farmaceuticos Lda, Sanofi AB, and Sanofi A/S) against four groups of defendants: (1) Accord Healthcare entities, (2) STADA entities (STADAPHARM GmbH, STADA Arzneimittel AG, STADA Nordic ApS), (3) Reddy Pharma entities (Reddy Pharma SAS, betapharm Arzneimittel GmbH, Dr Reddy's Srl), and (4) Zentiva entities (Zentiva France, Zentiva Pharma GmbH, Zentiva, k.s.). The patent at issue is European patent n° 2 493 466.
Key points raised during the interim conference:
1. The EPO Board of Appeal had conducted an oral hearing on 2-4 June 2025 in which the patent was upheld as granted, but the written reasoned decision had not yet been uploaded. The defendants were given three weeks from availability to comment, while Sanofi would comment in its brief due 8 August 2025 if possible.
2. Sanofi explained that French first-instance decisions invalidating the French part of the European patent were under appeal, with no hearing date yet scheduled.
3. The judge-rapporteur indicated the panel would independently assess counterclaim issues, considering both EPO and French decisions. A key question for obviousness assessment concerned what information a person skilled in the art would have derived from the Phase III TROPIC study and whether there was reasonable expectation of success. The parties identified experts (Sanofi: Dr. Nelson; Accord: Dr. Denmeade; Stada and Reddy relied on written evidence) who may be called for hot tubbing at the oral hearing in October 2025.
4. Sanofi's application for a tailored version of the 8 May 2025 order and Reddy's application (ORD_22246/2025) regarding disclosure of non-confidential elements of interim damages calculations were addressed. The court suggested circulating the original version within confidentiality clubs, to which all parties agreed.
5. Accord raised concerns about Sanofi's identical briefs across defendant groups, making it difficult to identify which statements responded to which defendant's pleadings. The court ruled that previously filed briefs would remain unchanged, but Sanofi must highlight passages not directed to all defendants in future briefs.
The order confirmed: (1) the final interim conference for 12 September 2025 at 10:00 via videoconference; (2) parties to submit topic suggestions by 1 September 2025; (3) oral hearing dates of 14-17 October 2025 at 09:00; (4) parties may comment on the EPO BoA written decision within three weeks of availability; and (5) Sanofi may file consolidated briefs but must highlight passages not directed to all defendants. The order is subject to review by the panel under R. 333 RoP.
Practitioner Note
This case demonstrates the evidentiary and procedural standards applied in patent matters before Munich (DE) Local Division. Understanding the court's reasoning in Sanofi-Aventis GmbH, Sanofi Mature IP, Sanofi AB, Sanofi S.r.l., Sanofi-Aventis France, Sanofi B.V., Sanofi A/S, Sanofi Winthrop Industrie, Sanofi Belgium, Sanofi-Aventis Deutschland GmbH, Sanofi - Produtos Farmaceuticos Lda vs STADA Nordic ApS, STADA Arzneimittel AG, STADAPHARM GmbH is valuable context for structuring arguments or assessing risk in similar proceedings.
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