Meril & Ors v Edwards (UPC_CFI_189/2024 & UPC_CFI_434/2024)
Decision date:
20 October 2025
Osborne Clarke summary
- This decision is part of a wider dispute between Meril and Edwards relating to prosthetic heart valves and their delivery assembly.
- In this case, Meril filed a revocation action against one of Edwards' patents relating to a prosthetic heart valve and a delivery assembly. The patent in suit is a third-generation divisional application. Meril challenged validity on the basis of added matter, and lack of novelty and inventive step.
- Edwards responded by filing a defence to revocation, a request to maintain the patent as granted (or, in the alternative, in an amended form). Edwards also filed an application to amend the patent and a counterclaim for infringement by Meril's offering and selling the "Octacor THV" and the "Navigator Inception" (and later amended to include the "Octapro THV" and "Navigator Pro") in the UPCA territory.
- In response, Meril argued that it did not infringe the patent or, alternatively, the court should reject Edwards' request for an injunction pursuant to Article 63 UPCA as it would be "disproportionate", or further in the alternative, the court should refer a question to the CJEU on the interpretation of Article 3(2) of the Enforcement Directive. Its final alternative argument was that the court should exclude the Octacor system from any injunction in sizes in which other self-expandable valves are not available and stay the injunction for 12 months.
- The Paris CD rejected Meril's request to revoke the patent and upheld the patent in amended form (as per auxiliary request 2). It also found that Meril had infringed the patent and granted an injunction.
- The court first dealt with some procedural points. Although there were ongoing opposition proceedings before the EPO that the court had not originally been notified of, the Paris CD noted its discretion to stay its proceedings where there are parallel opposition proceedings. In this case, the court declined to exercise its jurisdiction, noting that neither party requested a stay of the proceedings, which "implicitly" demonstrated the parties' interests in getting a quick decision from the Paris CD.
- Next, he court did not allow Meril to plead grounds of invalidity that were filed late in the proceedings. The Paris CD confirmed that the UPC operates a "front loaded" system and claimants are not be allowed to gradually introduce new arguments. However, the court did allow both parties to submit new evidence that disputed facts or evidence already put forward by the other side.
- In relation to the oral hearing, the court had allowed the parties to use presentation slides during the hearing, to aid the court's interpretation. There was some argument between the parties over whether the slides had introduced new arguments and were therefore an inadmissible extension of the scope of the proceedings. The court disagreed that the slides from both sides had done this, finding that they merely strengthened arguments already introduced.
- Turning to the substance of the matter, the Paris CD followed the principles of claim interpretation set out by the Court of Appeal in Nanostring v 10x Genomics, noting that the claims needed to be interpreted in the context of the embodiments and diagrams included in the patent. This ultimately meant that some of the claims as granted were held invalid due to added matter.
- One of Edwards' auxiliary requests was deemed to be sufficiently novel and inventive to be valid. In considering inventive step, the Paris CD focused on a "holistic approach" to inventiveness, rather than focusing on "isolated distinguishing features" of the claim. Although the person skilled in the art may have been aware of certain features from the prior art and it may have been possible to add them to the claim, the court found that there was no clear motivation to do so in this case.
- Article 63 UPCA sets out that the court may grant an injunction against an infringer aimed at prohibiting the continuation of the infringement. However, Article 64(4) UPCA states that in considering corrective measures, the court must take into account the need for "proportionality between the seriousness of the infringement and the remedies to be ordered, the willingness of the infringer to convert the materials into a non-infringing state, as well as the interests of third parties". The court noted that this appeared to be consistent with the Enforcement Directive (meaning a referral to the CJEU was not necessary) and the Agreement on Trade-Related Aspects of Intellectual Property. In line with this legislative framework, a general injunction to restrain future infringements is the "normal remedy" for patent infringement, but the court does have the discretion to tailor the injunction by "limiting its substantive scope or temporal effect" so that it is not disproportionate.
- Meril had sought to argue that no injunction should be granted because it would limit the diversity of treatments available to the detriment of the public interest. The court decided that Meril had not demonstrated that the availability of a variety of products in this specific field was essential to public health and therefore the "public interest" was not impacted. However, Meril did demonstrate that there was a "clear public need" for its XL-sized valves, which were carved out of the injunction (this was similar to the approach taken by the Munich LD in relation to another dispute between the same parties).
- Meril was also ordered to provide certain information relating to the infringement and to deliver up the infringing products.
- A recurring penalty payment of €20,000 per product was imposed for any non-compliance with the injunction and a recurring penalty payment of €1,000 for each day of delay with respect to the provision of information and delivery up.
Issue
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