F. Hoffmann-La Roche v A.Menarini Diagnostics (CFI, 5 December 2025)

Dhenne Avocats · 10 October 2026

Our analysis

Summary

In an order of 5 December 2025 (UPC_CFI_712/2025), given after a hearing, the Düsseldorf Local Division largely granted the application for provisional measures by F. Hoffmann-La Roche and Roche Diabetes Care against A. Menarini Diagnostics and two other Menarini group companies, based on EP 1 962 668 B1 (« sandwich » sensor for determining an analyte concentration) and directed at the GlucoMen iCan o3 continuous glucose monitoring system. It prohibited, in Germany, France and Italy, the manufacture, offer, placing on the market, use, import and possession of the infringing sensors and devices, ordered their delivery to a bailiff, information on their origin and distribution channels and an interim reimbursement of EUR 32,051.20 in costs, without requiring security. The order is of interest for construing a product claim in the light of a process claim, for an injunction against manufacture of a product made in China by a third party, and for assessing the necessity of measures in a sluggish market where each new patient lost is lost for good.

Facts and procedure

The sensor is made in China by Changsha Sinocare and distributed by the Menarini group. It is sold in Italy, where units were delivered in June and July 2025 on orders placed by a Roche employee. It is not yet marketed in Germany or France, but Berlin-Chemie presented it at an event on 20 July 2025 (paragraphs 17 and 19). Filed on 7 August 2025 as an ex parte application, it was notified to the respondents on 11 August, they replied on 23 September, and confidentiality orders were made in October 2025. The hearing took place on 7 November 2025. The respondents sought, in the alternative, security of at least EUR 1,500,000 (paragraph 23).

The applicable law

Provisional measures are governed by Article 62 UPCA and Rules 206 et seq. International jurisdiction rests on Regulation (EU) No 1215/2012 (Articles 4(1), 8(1), 71a and 71b), and the local division’s competence on Article 33(1)(b) UPCA, Rule 302.1 allows the applicants to sue together for their respective national parts. Construction follows Article 69 EPC and its Protocol.

Question

Does the UPC have jurisdiction over respondents based in Italy, Germany and France, are infringement and validity sufficiently certain, are urgency and necessity established, and what measures should be ordered?

Decision

The UPC, a common court under the Brussels I recast, has jurisdiction over Berlin-Chemie by reason of its seat and over the other two respondents because of the close connection within the group. The Düsseldorf division is competent because Berlin-Chemie’s seat is in Germany (paragraphs 77 to 79). The applicants may sue together for their national parts (paragraph 80). The patent is its own lexicon: « electrodes » include the contact layers, and the « entire width » means edge to edge of the substrate in the electrode region (paragraphs 110 to 143). As claim 1 is a product claim, the manufacturing route is in principle irrelevant (paragraphs 144 to 147 and 187). Literal infringement of claims 1 and 16 is sufficiently certain (paragraphs 151 to 189), the respondents offer the product in Germany, France and Italy, offering being understood in an economic sense, and market it in Italy (paragraphs 190 to 194).

It is not more likely than not that the patent is invalid (paragraphs 195 to 310). Granted in 2009 without opposition or national revocation action (paragraph 197), it validly claims the priority of 19 December 2005, the « same invention » test being applied as in Hartmann Packaging v Omni-Pac and Dolle v Fakro (paragraphs 199 to 218). WO ‘447, citable under Article 54(3) EPC, does not disclose electrodes extending over the entire width: combining values taken from separate ranges is arbitrary (paragraphs 222 to 242), US ‘006 is not prior art (paragraph 243). Inventive step was assessed under the approach set out by the Court of Appeal on 25 November 2025 (Meril v Edwards, Amgen v Sanofi): no combination starting from US ‘871, WO ‘424, WO ‘447 or US ‘006 leads to the invention, for want of disclosure of feature 1.4 and of any motivation to combine fundamentally different structures (paragraphs 258 to 310).

There was no undue delay: there is no general duty to monitor the market, knowledge of acts by the manufacturer Sinocare does not necessarily start time running against the distributors, and sufficient knowledge dates from the first microscopy results of 12 July 2025, so the application filed on 7 August 2025 was in time (paragraphs 313 to 357). Measures are necessary: in the sluggish market for continuous glucose monitoring systems, new patients lost during market entry are lost for good, and the patent expires in December 2026 (paragraphs 358 to 368). The balance of interests favours the applicants, the consequences relied on (public tenders, reputation, lost profits) being the ordinary results of an injunction (paragraphs 369 to 380).

Security allowing continued use, or a ban limited to low-price sales, would not suffice (paragraphs 383 and 384). The injunction also covers manufacture, although the product is made in China by Sinocare, as the respondents are not entitled to make it in the states concerned in any event (paragraph 386). Information on origin, distribution channels and third parties involved was granted, but not details of individual offers and deliveries, which mainly serve to calculate damages (paragraphs 390 to 393). The respondents bear all the costs, the part refused being minor (paragraphs 395 to 397), and no security was required from the applicants, no undue burden being alleged (paragraphs 398 to 403). The operative part grants the injunction for Germany, France and Italy subject to penalty payments of up to EUR 10,000 per product or EUR 30,000 per day, delivery of the products to a bailiff, information within three weeks for the period from 11 April 2016 and an interim reimbursement of EUR 32,051.20, otherwise dismisses the application, orders the respondents to bear the costs, declares the order enforceable without security and sets the value in dispute at EUR 1,000,000. The panel was presided over by Judge Thomas.

Key points for practice

• An independent process claim and its description bear on the scope of a product claim only if the patent indicates that they also describe features of the product (paragraphs 144 to 147).
• An injunction may cover manufacture even if the infringing product is made only by a third party outside the Contracting Member States.
• In provisional proceedings, information on individual offers and deliveries, which serves to quantify damages, is not granted. Only information needed to stop the infringement is (paragraphs 390 and 391).
• Practical point: time for urgency runs from sufficiently reliable knowledge, such as the first test results on a purchased product, not from the mere presence of the product at trade fairs or in a state not covered.

Provisions applied

Agreement on a Unified Patent Court

Arts 25(a), 32(1), 33(1)(b), 47(1), 62, 69 and 82(2)

Rules of Procedure

Rules 206, 209, 211, 213, 262A, 302.1, 352.1 and 354.3

European Patent Convention

Art. 54, Art. 56, Art. 87 and Art. 69 and Protocol

Regulation (EU) No 1215/2012

Arts 4(1), 8(1), 71a and 71b

Case law cited

10x Genomics v NanoString, Court of Appeal, 26 February 2024, VusionGroup v Hanshow, Court of Appeal, 13 May 2024, Mammut Sports Group v Ortovox Sportartikel, Court of Appeal, 25 September 2024, Ortovox v Mammut, Düsseldorf Local Division, 9 April 2024, SES-imagotag v Hanshow, Munich Local Division (UPC_CFI_292/2023), Meril v Edwards, Court of Appeal, 25 November 2025, Amgen v Sanofi-Aventis Deutschland, Court of Appeal, 25 November 2025, Biolitec v Light Guide Optics, Court of Appeal, 24 February 2025, Insulet v EOFlow, Court of Appeal, 30 April 2025 (UPC_CoA_768/2024), Sumi Agro v Syngenta, Court of Appeal, 3 March 2025 (UPC_CoA_523/2024), Hartmann Packaging v Omni-Pac, Düsseldorf Local Division, 15 October 2025, Dolle v Fakro, Hamburg Local Division, 5 November 2025

Related decisions

• F. Hoffmann-La Roche v A. Menarini Diagnostics, 1 October 2025, confidentiality order (Rule 262A).

Prepared by Dhenne Avocats from the official decision, consulted on 10 October 2026. The database is updated every week, on Friday. Only the official text is authoritative.