Meril & Ors v Edwards Lifesciences (UPC_CoA_464/2024, UPC_CoA_457/2024, UPC_CoA_458/2024, UPC_CoA_530/2024, UPC_CoA_532/2024, UPC_CoA_533/2024, UPC_CoA_21/2025 and UPC_CoA_27/2025)
Decision date:
25 November 2025
Osborne Clarke summary
- This decision concerned appeals and cross-appeals brought by various Meril companies and Edwards Lifesciences against a number of decisions of the Paris CD and the Munich LD. The dispute related to the validity of Edwards' patent relating to a system comprising a prosthetic heart valve and a delivery catheter and its alleged infringement by Meril's "Myval Octacor" valve and its “Navigator” and “Navigator Inception” delivery systems.
- In summary, the Court of Appeal upheld the Paris CD's finding that the patent was valid in amended form. It also endorsed the Munich LD's finding of infringement, but amended the scope of the injunction.
- Edwards brought an infringement action against Meril India and Meril Germany before the Munich LD on 1 June 2023. Meril Italy subsequently brought a direct revocation action against Edwards before the Paris CD on 4 August 2023. The revocation action and revocation counterclaims were later consolidated at the Paris CD, which upheld the patent in amended form (auxiliary request II) on 19 July 2024. Both parties appealed this decision. On 15 November 2024, the Munich LD found infringement and ordered Meril India and Meril Germany to cease and desist from infringing acts across sixteen Member States, with a carve out for certain products (discussed below). Both parties appealed certain aspects of this decision.
- The most important aspect of the Court of Appeal's decision was inventive step. The approach taken was closely aligned with the Court of Appeal's other panel's decision in Amgen v Sanofi & Regeneron, which was handed down on the same day. Even though the judgments do not expressly cross-refer, a number of paragraphs are identical.
- The Court of Appeal acknowledged that national courts of various EPC countries have different approaches to inventive step, with some applying the problem-solution approach used by the EPO, while others use more "holistic" approaches. Despite these differences, the court emphasised that they are all merely guidelines that, when properly applied, should and generally do lead to the same conclusion.
- Adopting the same test as the panel in Amgen, the court endorsed the holistic approach. As explained in more detail in our summary of the Amgen decision, the first step is to establish the objective problem and the second step is to identify a realistic starting point in the state of the art in the relevant field of technology. Having done so, the court will then consider whether the skilled person at the effective date would (and not only “could”) have arrived at the claimed solution. A claimed solution must be considered obvious when the person skilled in the art would take the next step, prompted by the pointer or as a matter of routine, and arrive at the claimed invention. The burden of presentation and proof lies with the party invoking invalidity of the patent.
- The panel in Meril also stated that it is not necessary to show improvement of the technical teaching as defined by the patent claims over the prior art. It noted that an inventive step may be found if the patent claims disclose a non-obvious alternative to solutions known in the prior art.
- Applying this framework to the prior art citation Levi, the Court of Appeal held that there was no incentive to change the valve frame disclosed in Levi into a frame made up entirely of hexagonal shaped cells as required by the patent.
- The Court of Appeal also considered Meril's argument that the amended claim was obvious over Levi in combination with prior art on vascular stents. It held that while the skilled person would be aware of prior art in related fields (such as stents), they would bear in mind that different devices have very different requirements. It agreed with the Paris CD that the skilled person would need a strong motivation to replace a feature taught by Levi in relation to heart valves with one disclosed for another device in another field. In this instance, the Court of Appeal held that there was no such motivation.
- The court dismissed Meril's other obviousness arguments for similar reasons. It also rejected Meril’s added matter and novelty objections, finding the patent valid on the basis of auxiliary request II. In addition, it rejected Edwards' appeal against the Paris CD's conclusion that the main request and auxiliary request I were invalid for added matter.
- The Court of Appeal confirmed the infringement finding of the Munich LD and provided important guidance on proportionality considerations for the grant of an injunction in the medical device context. The court stated that Article 64 UPCA and the Enforcement Directive grant patent proprietors a high level of protection such that the recall, removal from distribution channels and destruction of infringing products should be considered the norm. Only if measures are disproportionate can they be refused. It noted that this might be the case if, for example, the infringement was minor or the infringer was willing and able to eliminate the infringing nature of its product.
- When considering proportionality of injunctive relief and corrective measures, the interests of third parties, such as patients, as well as of the parties, may be taken into account. The court endorsed the Munich LD's finding that patient interests justify an exception to the right to injunctive relief and corrective measures if it is established that the infringing embodiment is the sole available treatment method or represents an improvement upon available treatment methods, resulting in a notable enhancement of patient care.
- The Court of Appeal agreed with the Munich LD that there was a legitimate interest in excluding Meril's XL devices from the injunction as there was no equivalent product to treat this patient group. However, it agreed with Meril's argument that permission to use Meril's XL products should not depend on an assessment undertaken by Edwards doctors that a patient had no other treatment options. It considered that a notification of an intention to use Meril’s XL device by a physician confirming that it was the only available treatment option was sufficient. The Court of Appeal therefore amended the injunction and orders for corrective measures accordingly.
- The court rejected a number of procedural appeals. These included Edwards' appeal against the Paris CD's ruling that it was competent to hear the direct revocation action brought by Meril Italy despite the pending infringement case against Meril India and Meril Germany in the Munich LD, Edwards' appeal against the Munich LD's refusal to extend the injunction to Romania and Meril's appeal against a decision permitting Edwards to amend the patent.
Issue
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