Edwards Lifesciences v Meril Life Sciences (CFI, 15 November 2024)

Dhenne Avocats · 10 October 2026

Our analysis

Summary

In a decision of 15 November 2024 (UPC_CFI_15/2023), the Munich Local Division held that Meril’s Myval Octacor transcatheter heart valve and Navigator delivery systems literally infringe claims 1, 2, 4 and 5 of Edwards Lifesciences’ EP 3 646 825, as maintained in amended form by the Central Division. The decision addresses several questions of principle: UPC jurisdiction over acts before 1 June 2023, allocation of cases among the German local divisions, the conditions for a stay after bifurcation and, above all, the weight of the public interest for a medical device, which the Division accepted in principle but found largely met by the medical request portal offered by Edwards. It granted an injunction for sixteen States, recall, destruction, information, publication by Edwards and an interim award of EUR 663,000, without making its decision conditional on the outcome of the appeal on validity.

Facts and procedure

Edwards sued Meril GmbH (Bonn) and Meril Life Sciences (India) on 1 June 2023. Meril counterclaimed for revocation. On 28 March 2024 the Division referred the counterclaims to the Paris Central Division, already seised of a revocation action by Meril Italy, and proceeded with the infringement action. On 19 July 2024 the Central Division maintained the patent on the basis of auxiliary request II. Appeals are pending. The oral hearing took place on 24 September 2024.

The applicable law

The Division applied Articles 3(c), 32(1)(a), 32(3b), 33(1)(b) and 34 UPCA, Rules 37.4, 263 and 295(c)(i) and (m) RoP, and Articles 63(1) and 64(1) and (4) UPCA for the weighing of third-party and public interests.

Question

Once the Central Division has maintained the patent, should the infringement action be stayed, and does the public interest in access to large valves justify limiting the injunction and recall?

Decision

The UPC has jurisdiction over acts before 1 June 2023, as there is no conflicting intertemporal rule. The opposite view would leave no court able to award damages for those acts. The claimant’s choice determines which German local division is competent, national law being irrelevant, and Meril Life Sciences was properly sued under Article 33(1)(b). The late addition of Romania was refused under Rule 263. After bifurcation and maintenance of the patent, a stay can rest only on Rule 295(c)(i) or (m) and requires the Central Division’s decision to be manifestly and prima facie wrong, which Meril failed to show on form or substance. Literal infringement was found, the commissure posts acting as side struts and foreshortening on crimping being negligible (about 1.4%). Article 34 allows relief for every State where the patent has effect once an act is proven in one of them.

On the public interest, the Division relied on the discretion left by Articles 63(1) and 64(1) and (4). Meril, already found to be an unwilling licensee by the Bundespatentgericht in compulsory licence proceedings, remained one. The public interest may nonetheless be considered, as patients have no influence over the defendant’s conduct. A need exists for large valves (annulus above 30 mm), but the medical request portal, which provides a single-use licence, meets it. Large devices scheduled for implantation in an identified patient as of 15 November 2024 are excluded from recall and destruction, and the practitioner may seek an individual exemption, to which Edwards must respond without delay. Intermediate sizes and other features justify no exemption: the convenience for practitioners of having several treatment options is not enough, there must be a sole treatment or a notable improvement in patient care, and the LANDMARK trial only shows non-inferiority.

No grace period was granted, and a payment in lieu of an injunction has no legal basis, Meril’s lump-sum offer of EUR 100,000 being in any event inadequate for a dispute valued at about EUR 8 million. The Division granted an injunction for Belgium, Bulgaria, Denmark, Germany, Estonia, Finland, France, Italy, Latvia, Lithuania, Luxembourg, the Netherlands, Austria, Portugal, Sweden and Slovenia, subject to a penalty of up to EUR 20,000 per product, declared infringement, ordered information from 17 March 2021 within three weeks and recall and destruction within one week, under a penalty of EUR 1,000 per day, allowed Edwards to publish the decision in five media but refused to order publication by Meril, and held Meril liable for damages with an uncontested interim award of EUR 663,000 (Arts. 63, 64, 67, 68 and 80 UPCA, Rules 119, 191 and 354.3 RoP). Meril bears the costs, the decision is enforceable without security, Meril having withdrawn its request, and no condition under Article 56(1) UPCA and Rule 118.2(a) RoP was imposed, given Meril’s incorrect claim that the Central Division had ignored revocation arguments and the creation of Meril Italy to delay the proceedings.

Key points for practice

• Once the Central Division has maintained the patent, a defendant seeking a stay must show a manifest error in that decision.
• The public interest may temper remedies even against an unwilling licensee, and an individual licensing mechanism may suffice to meet it.
• A decision given after the Central Division has maintained the patent need not be made conditional on the outcome of the appeal (Rule 118.2(a) RoP), particularly where the defendant has engaged in delaying tactics.
• Practical point: in the medical field, a patentee is well advised to offer its own patient access mechanism, which may avoid a broader limitation of the injunction.

Provisions applied

Agreement on a Unified Patent Court

Arts. 3(c), 32(1)(a) and (3b), 33(1)(b), 34, 56(1), 63, 64, 67(1), 68, 69(1) and 80

Rules of Procedure

Rules 19.1, 37.4, 118.1, 118.2(a), 119, 191, 263, 295, 352.2, 354.1 and 354.3

Case law cited

Court of Appeal, 26 February 2024, UPC_CoA_335/2023, Paris Central Division, 19 July 2024, Meril Italy v Edwards Lifesciences, Paris Central Division, order of 13 November 2023, Edwards Lifesciences v Meril Italy (UPC_CFI_255/2023), Court of Appeal, order of 6 September 2024 (UPC_CoA_457/2024).

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.