Meril Life Sciences v Edwards Lifesciences (CFI, 20 October 2025)

Dhenne Avocats · 10 October 2026

Our analysis

Summary

The Paris Central Division dismisses Meril’s revocation action against Edwards Lifesciences’ EP 4 151 181 (prosthetic heart valve and delivery assembly), maintains the patent as amended by Auxiliary Request 2 and grants the counterclaim for infringement against the Octacor and Octapro systems. The main interest of the decision lies in the injunction: the panel carves out XL-size valves intended for aortic annuli larger than 30 mm, the only treatment available for those patients, until another valve designed for them is approved. The decision shows how the public interest may lead the court to tailor, rather than refuse, an injunction against a medical device.

Facts and procedure

Meril Life Sciences, Meril GmbH and Meril Italy brought the revocation action on 15 May 2024 (UPC_CFI_189/2024), Edwards responded with a counterclaim for infringement (UPC_CFI_434/2024), later extended to the Octapro valve and the Navigator Pro system (paragraphs 6, 7 and 179). The patent, a divisional, has thirteen claims, one of them independent (paragraphs 2 and 3). An interim conference took place on 17 April 2025 and the oral hearing on 11 September 2025 (paragraphs 11 and 12). An EPO opposition was pending, in which the Opposition Division had issued a preliminary opinion (paragraph 13).

The applicable law

The panel applies Arts 76(1), 54, 56 and 123 EPC on validity, Arts 63 and 64 UPCA on the injunction and corrective measures, read in the light of Art. 3 of Directive 2004/48, and the Rules of Procedure on front-loading of the written procedure.

Question

Is the patent valid as granted or under one of the auxiliary requests, is it infringed, and can the public interest justify limiting the injunction?

Decision

The panel declines to stay the proceedings pending the opposition, since neither party sought a stay and the case was well advanced (paragraphs 14 to 17). It excludes as late a new added-matter attack first raised in the reply, given the front-loaded nature of the procedure (paragraphs 25 to 30). The patent as granted infringes Art. 76(1) EPC because the parent application discloses heart valves only (paragraphs 83 to 95). Auxiliary Request 1 lacks novelty (paragraphs 121 to 138). Auxiliary Request 2 is novel and inventive: Hariton teaches away from slack in the outer skirt, and combining Lotus or Braido with Hariton would require structural changes the skilled person would approach with caution (paragraphs 142 to 175). Claims 1, 4 and 6 to 12 as amended are infringed (paragraphs 184 to 194). An injunction is the rule, but the Court may limit its scope or duration where it would be disproportionate or contrary to the public interest (paragraphs 195 to 205). Freedom of product choice and the LANDMARK trial results are not enough. Only the lack of an alternative for annuli above 30 mm establishes a public interest (paragraphs 207 to 213). The panel refuses to make use of XL valves subject to an approval portal run by the patentee (paragraphs 214 to 217). It orders information to be provided within four weeks and delivery up of products within three weeks, backed by penalties of up to EUR 20,000 per product and EUR 1,000 per day of delay, the request for an interim award of damages under Rule 119 is dismissed for lack of detail (paragraph 224). Each party bears its own costs of the revocation action, while the counterclaim defendants bear the counterclaim costs jointly and severally, its value being set at EUR 8,000,000 (paragraphs 225 and 226).

Key points for practice

• The public interest may justify a targeted and temporary carve-out from the injunction, confined to products for which there is no therapeutic alternative (paragraphs 212 to 219).
• A new invalidity attack first raised in the reply is excluded as late (paragraphs 25 to 28).
• The court will not leave the patentee in control of physicians’ access to the product carved out of the injunction (paragraphs 214 to 217).
• Practical point: a defendant relying on public health must show that a defined group of patients has no alternative, freedom of product choice alone will not do.

Provisions applied

Agreement on a Unified Patent Court

Arts 33(10), 63 and 64

Rules of Procedure

Rules 9, 13, 30, 36, 44, 52, 58, 105, 119, 263 and 295

European Patent Convention

Art. 54, 56, 76, 84 and 123

Directive 2004/48/EC

Art. 3

Case law cited

NanoString v 10x Genomics, Court of Appeal, 26 February 2024 (UPC_CoA_335/2023), Court of Appeal, 28 May 2024, UPC_CoA_22/2024, Court of Appeal, 21 November 2024, UPC_CoA_456/2024, Court of Appeal, 14 February 2025, UPC_CoA_382/2024, Court of Appeal, 20 April 2025, UPC_CoA_768/2024, NJOY Netherlands, Paris Central Division, 28 February 2025 (UPC_CFI_312/2023), and several decisions of the central and local divisions in Paris, Munich, Hamburg, Düsseldorf and Brussels.

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.