Sanofi A/S, Sanofi - Produtos Farmaceuticos Lda, Sanofi B.V., Sanofi Belgium, Sanofi Winthrop Industrie, Sanofi-Aventis Deutschland GmbH, Sanofi-Aventis France, Sanofi-Aventis GmbH, Sanofi S.r.l., Sanofi AB v. Accord Healthcare S.L.U., Accord Healthcare GmbH (AT), Accord Healthcare BV, Accord Healthcare GmbH (DE), Accord Healthcare Italia Srl, Accord Healthcare B.V., Accord Healthcare, Unipessoal Lda., Accord Healthcare AB, STADAPHARM GmbH, STADA Arzneimittel AG, STADA Nordic ApS, Reddy Pharma SAS, betapharm Arzneimittel GmbH, Dr Reddy's Srl, Zentiva France, Zentiva Pharma GmbH, Zentiva, k.s.

ORD_69481/2024

This procedural order in a complex pharmaceutical infringement case involving Sanofi against multiple defendants sets the stage for intensive litigation. The core dispute revolves around the inventive step of EP 2 493 466, specifically concerning the reasonable expectation of success derived from clinical trials (TROPIC study). The court has scheduled extensive expert testimony and oral hearings to allow the panel to address highly technical factual questions related to oncology drug development before making a final decision on validity and infringement. This case highlights the UPC's capacity to handle deep scientific and medical complexities in patent disputes.

Jurisdiction
European UPC
Court
Munich (DE) Local Division
Case Number
ORD_69481/2024
Decision Date
15 September 2025

What the Court Held — Ratio Decidendi

This is a procedural order, not a substantive ruling. The panel has scheduled detailed hearings to address complex factual questions regarding the reasonable expectation of success in oncological clinical trials, which will be used to determine obviousness/inventive step. The court confirmed that expert testimony would be heard to bridge the gap between legal and factual issues.

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 A/S, Sanofi - Produtos Farmaceuticos Lda, Sanofi B.V., Sanofi Belgium, Sanofi Winthrop Industrie, Sanofi-Aventis Deutschland GmbH, Sanofi-Aventis France, Sanofi-Aventis GmbH, Sanofi S.r.l., Sanofi AB vs Accord Healthcare S.L.U., Accord Healthcare GmbH (AT), Accord Healthcare BV, Accord Healthcare GmbH (DE), Accord Healthcare Italia Srl, Accord Healthcare B.V., Accord Healthcare, Unipessoal Lda., Accord Healthcare AB, STADAPHARM GmbH, STADA Arzneimittel AG, STADA Nordic ApS, Reddy Pharma SAS, betapharm Arzneimittel GmbH, Dr Reddy's Srl, Zentiva France, Zentiva Pharma GmbH, Zentiva, k.s. is valuable context for structuring arguments or assessing risk in similar proceedings.

Related Cases

patentApp_64019/2024

air up group GmbHvsGuangzhou Aiyun Yanwu Technology Co., Ltd.

In this UPC case concerning an application for preliminary measures, the Court addressed a critical procedural hurdle: service of documents on a defendant domiciled in China. Despite extensive efforts—including formal and informal attempts under the Hague Service Convention—the court found that traditional service methods had failed to yield a certificate of delivery. The judge ruled that these unsuccessful steps constituted 'good service' under Rule 275.2 RoP, effectively allowing the proceedings to move forward despite the lack of confirmed receipt by the defendant.

patentApp_30222/2024

Headwater Research LLCvsMotorola Mobility LLC, Motorola Mobility Germany GmbH, Motorola Mobility International Sales LLC, Digital River Ireland, Ltd.

This decision from the Munich Local Division addresses jurisdictional objections raised by Motorola entities in a patent infringement case brought by Headwater Research LLC concerning wireless mobile devices. The court dismissed these objections, affirming its jurisdiction under the UPC Agreement. Crucially, the ruling clarifies the scope of Article 33(1)(b) EPCG, limiting its application and confirming that the main infringement proceedings will proceed to trial. This decision provides important guidance on how jurisdictional rules are interpreted in complex multi-defendant cases within the UPC.

patentApp_22060/2025

Samsung Electronics Co., LtdvsZTE Deutschland GmbH, ZTE France SASU, ZTE Netherlands B.V.

In a procedural order concerning an infringement action, the UPC Local Division in Mannheim addressed the varying service dates of three related ZTE entities. The court ruled that to ensure procedural fairness and efficiency, all parties agreed to harmonize the deadlines for submitting defenses and revocation counterclaims. This decision establishes a uniform timeline across the group defendants, streamlining the ongoing litigation.

patentApp_27016/2025

Arbutus Biopharma CorporationvsModerna, Inc.

In a complex biotech patent dispute involving Arbutus Biopharma Corporation and numerous Moderna entities, the UPC issued a procedural order in June 2025. The defendants sought to challenge prior case management orders and preliminary objections raised by the claimants across two infringement actions (UPC_CFI_191/2025 and UPC_CFI_192/2025). The court granted the claimants a week to respond, indicating that the core substantive issues remain pending while procedural challenges are addressed.

patentORD_32908/2025

TIRU SASvsMAGUIN SAS

This UPC Court of Appeal decision addresses an appeal challenging an initial ex parte order for evidence preservation concerning a waste incineration patent (EP 3 178 578). The court provided important guidance on the scope of judicial review during evidence gathering, emphasizing that judges ordering evidence do not need to assess patent validity or require disclosure of all known prior art. Ultimately, the appeal by MAGUIN was rejected as they failed to meet the burden of proving why their specific prior art should have been disclosed.

Arctic Invent — IP Strategy

Dealing with a patent challenge?

Whether it's a Section 3(d) rejection, a post-grant opposition, or a FRAND dispute, Arctic's patent litigation team has handled it. Get a strategy call.

Talk to our patent team →

Disclaimer: This page contains an automated summary based on publicly available judicial records. The content is generated for informational purposes only and does not constitute legal advice. Always verify details against the original source judgment before relying on this information for any legal purpose. If you believe any information is inaccurate, please contact us.

Strategy Consult

Facing a similar patent matter?

Arctic's litigation team uses precedent data like this to build winning arguments.

Get a Strategy Call