Edwards Lifesciences v Meril Life Sciences (CFI, 21 July 2025)

Dhenne Avocats · 10 October 2026

Our analysis

Summary

In a decision of 21 July 2025 (UPC_CFI_380/2023), the Nordic-Baltic Regional Division upheld Edwards Lifesciences’ infringement action on EP 3 769 722 (a delivery system for a transcatheter heart valve) against Meril Life Sciences, Meril Germany and four distributors concerning the Navigator device. The patent as granted was held invalid for added matter and, as to claim 9, insufficiency, but it was maintained in the form of auxiliary request 1’, which the Navigator infringes. The decision matters for practice on three points: the liability of a European subsidiary appearing only as the group’s commercial contact, the refusal to withhold an injunction on public health grounds, and the refusal to apply Article 65(3) UPCA to reshuffle the order of auxiliary requests after the hearing.

Facts and procedure

The action, brought on 27 October 2023, concerns the offering and marketing of the Navigator, in particular in Estonia and Lithuania. The defendants counterclaimed for revocation. Edwards filed 22 conditional auxiliary requests. The panel refused to stay the proceedings despite the pending EPO opposition, and the oral hearing took place in Stockholm on 16 January 2025. On 3 March 2025 the Opposition Division maintained the patent in an amended form that had not been put before the UPC (paragraphs 8 to 21 and 272).

The applicable law

A patent may be revoked for added matter, insufficiency or lack of inventive step (Article 65(2) UPCA, Article 138(1) EPC). A finding of infringement opens the way to an injunction, corrective measures, information and damages (Articles 63, 64, 67 and 68 UPCA), and to an interim award of damages (Rule 119 RoP).

Question

Is the patent valid, if need be as amended, does the Navigator infringe it, and which remedies should be ordered against each defendant?

Decision

The preliminary objection concerning Meril Germany was dismissed (paragraphs 43 to 48). Claim 1 as granted contains added matter, as do claims 7, 9 and 10, claim 9 is also insufficiently disclosed, Edwards having failed to show the obvious error it relied on (paragraphs 95 to 101, 124 to 161, 169 to 178 and 269). Inventive step was, however, acknowledged over Marchand and Bowden combined with the other prior art and common general knowledge (paragraphs 179 to 268). The Division took the auxiliary requests in the order Edwards had set during the proceedings, Article 65(3) UPCA not applying to applications to amend (paragraphs 274 and 275), and maintained the patent as per request 1’ (paragraphs 276 to 279). The Navigator literally infringes it (paragraphs 284 to 289). Meril Germany, presented on the group website as “Meril European Headquarters” and the sole EU contact, is a source of the offer and jointly liable with Meril India. The distributors are liable only for Estonia or Lithuania (paragraphs 294 to 296 and 328). An injunction was granted with a penalty of up to EUR 10,000 per violation, the public health argument concerning the valve rather than the delivery system, for which an alternative exists (paragraphs 305 to 307). Recall, destruction and information were ordered with a daily penalty of EUR 1,000, for acts after grant on 7 June 2023, publication was refused. An interim award of EUR 500,000 was made, the defendants bear all costs of the infringement action and 75% of those of the counterclaim (paragraph 345).

Key points for practice

• A subsidiary presented as the European headquarters and sole commercial contact in the EU may be treated as a source of the offer made on the group website and held jointly liable with its parent (paragraphs 294 and 295).
• A public interest objection to an injunction must concern the infringing product itself. It fails where a substitute device is available (paragraph 306).
• The order of auxiliary requests announced during the proceedings binds the proprietor, who cannot propose after the hearing to follow the version upheld by the EPO (paragraph 275).
• Practical point: proprietors should put before the UPC, without delay, any claim set they defend before the Opposition Division.

Provisions applied

Agreement on a Unified Patent Court

Arts 33(1), 56(1), 63, 64, 65(2) and (3), 67, 68, 69, 76(1), 80 and 82

Rules of Procedure

Rules 118, 119, 191 and 354.1

European Patent Convention

Arts 56, 67 and 138(1)

Case law cited

NanoString v 10x Genomics, Court of Appeal, 26 February 2024, UPC_CoA_335/2023, Court of Appeal, 14 December 2024, UPC_CoA_402/2024, Court of Appeal, 2 June 2025, UPC_CoA_156/2025, Paris Central Division, UPC_CFI_309/2023, Düsseldorf Local Division, 28 January 2025, UPC_CFI_355/2023, Munich Local Division, 4 April 2025, UPC_CFI_501/2023.

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.