Context: The patent dispute between Edwards Life Sciences and Meril Lifescience over prosthetic heart valves has been running for several years. In the United States, Meril argued successfully that its importation was protected under a “safe harbor” provision of the Hatch-Waxman Act, which exempts activities “solely for uses reasonably related” to obtaining Food and Drug Administration (FDA) approval. In the UK, Edwards scored a partial win (September 29, 2020 High Court of Justice decision). But in the Unified Patent Court (UPC), Edwards has made some headway:
- The Paris seat of the Central Division (CD) upheld an Edwards prosthetic heart valve patent, EP  EP3646825 (“A system comprising a prosthetic valve and a delivery catheter”) (July 20, 2024 ip fray article). A few months later, the Munich Local Division (LD) enjoined Meril over EP’825 (November 15, 2024 ip fray article).
- In the spring, the Munich LD handed down a second Edwards v. Meril injunction (April 4, 2025 ip fray article), the patent-in-suit being EP3669828 (“Prosthetic heart valve”).
What’s new & direct impact: Edwards has now won its third UPC injunction, in the form of a court-confirmed and court-enforceable settlement (PDF) that amounts to Meril’s surrender over EP2628464 (“Prosthetic valve”). It is enforeceable just like a court-ordered injunction. The case had temporarily been stayed, but in June 2024 the Technical Boards of Appeal (TBA) of the European Patent Office (EPO) upheld the patent in an amended form. The Nordic-Baltic Regional Division (RD) had scheduled the oral hearing for July 18, 2025 (last Friday), but the parties settled the previous week, on a basis that is a victory for Edwards.
Wider ramifications:
- It is difficult to compare cases across jurisdictions when they are years apart, but the argument can be made that the way Edwards is getting leverage over Meril in the UPC is another proof of concept for the new multi-country judiciary.
- Meril filed an EU antitrust complaint last year (May 13, 2024 article by Competition Policy International), but if the European Commission’s (EC) Directorate-General for Competition (DG COMP) doesn’t open formal investigations within about a year, it is ever less likely that the complaint will make an impact.
- This is not the first court-confirmed. court-enforceable settlement of its kind. Last week, the Milan LD confirmed a settlement between Pirelli and KingTyre (July 15, 2025 UPC order (PDF)).
The related complaint was filed in the Nordic-Baltic RD on the first day the UPC accepted any cases: June 1, 2023. But it was temporarily stayed pending the outcome of the EPO proceedings.
It may have played a role that proceedings in the Nordic-Baltic RD can be rather comprehensive with potential expert examinations and cross-examinations.
Court and counsel
Panel: Presiding Judge Stefan Johansson, Judge-rapporteur Kai Härmand (Talinn, Estonia), Judge Rute Lopes (Lisbon, Portugal) and Technically Qualified Judge Elisabetta Papa.
Counsel for Edwards: Advokatbyrån Gulliksson AB’s Magnus Dahlman, Powell Gilbert’s Siddharth Kusumakar, Bryce Matthewson and Adam Rimmer; and Thum & Partner’s Dr. Jonas Weickert and Bernhard Thum.
Counsel for Meril: Hogan Lovells’s Dr. Andreas von Falck (who signed the settlement on Meril’s behalf), Dr. Alexander Klicznik, Kerstin Jonen, Dr. Felipe Zilly, Dr. Lukas Wollenschlaeger, Beatrice Wilden and Dr. Kyra Lueg-Althoff; and Sandart’s Karin Westerberg and Julia Ericsson.