F. Hoffmann-La Roche AG & Roche Diabetes Care GmbH v. A.Menarini Diagnostics S.r.l. & Others

This case concerns an application for provisional measures (interim injunction) under Rule 206 of the Rules of Procedure filed by F. Hoffmann-La Roche AG and Roche Diabetes Care GmbH (collectively 'Roche') against A.Menarini Diagnostics S.r.l., BERLIN-CHEMIE AG (trading as A.MENARINI DIAGNOSTICS DEUTSCHLAND), and A.Menarini Diagnostics France SASU (collectively 'Menarini') before the Local Chamber Düsseldorf of the Unified Patent Court (Case No. UPC_CFI_712/2025).

The patent in suit is European Patent EP 1 962 668 B1, which protects an 'implantable sensor for determining a concentration of at least one analyte in a medium,' particularly a sandwich sensor for continuous glucose monitoring. The patent was filed on December 6, 2006, claiming priority from December 19, 2005, and was granted on June 17, 2009. It is currently in force in Germany, France, Italy, and the United Kingdom. Roche Diabetes Care GmbH is the sole proprietor of the German part of the patent, while F. Hoffmann-La Roche AG owns the French and Italian parts.

The accused product is the CGM system 'GlucoMen iCan o3,' a continuous glucose monitoring system for diabetes patients that uses minimally invasive sensor technology. The product is manufactured by Changsha Sinocare Inc. in China, which has an exclusive distribution agreement with F. Hoffmann-La Roche AG for marketing the product in over 20 European countries, including Italy, Germany, and France. The Menarini defendants are part of the Menarini Group, with A.Menarini Diagnostics S.r.l. serving as the European distribution center and EU importer of the accused product.

The court addressed two key legal questions: (1) whether an independent process claim and its corresponding description can be relevant for determining the scope of protection of an independent product claim, and (2) whether an injunction covering the making of a product can be issued when the infringing product is manufactured by a third party outside the contracting member states. The court held that an independent process claim and its description can only be relevant for determining the scope of protection of an independent product claim if the patent specification indicates that they also describe characteristics of the claimed product. The court further held that an injunction covering the making of a product may be issued even if the infringing product has so far been manufactured by a third party outside the contracting member states.

Following an oral hearing on November 7, 2025, the court issued its order on December 5, 2025, granting the provisional measures. The court ordered the defendants to cease and desist from manufacturing, offering, putting on the market, importing, exporting, or using the infringing implantable sensors and devices, subject to penalty payments of up to EUR 10,000 per product or EUR 30,000 per day for ongoing infringements. The defendants were also ordered to deliver up the infringing products to a court bailiff for safekeeping until a final decision on the destruction claim or a settlement is reached. Additionally, the defendants were ordered to provide detailed information about the origin, distribution channels, and identity of third parties involved in the manufacture and distribution of the infringing products. The defendants were ordered to pay provisional costs of EUR 32,051.20 and bear the costs of the proceedings. The order is enforceable without security, and the value in dispute was set at EUR 1,000,000. Both parties were informed of their right to appeal within 15 days of service.