Meril Italy Srl, Meril GmbH and Meril Life Sciences Pvt Ltd. v. Edwards Lifesciences Corporation, Decisions of the Court of Appeal of the UPC concerning EP 3 646 825, 25 November 2025
The UPC Court of Appeal (“CoA”) handed down its appeal decisions in the long-standing saga between Edwards Lifesciences and Meril in relation to prosthetic heart valves, confirming the validity of EP 3 646 825 (“EP 825”) as previously upheld by the Paris Central Division (“CD”) and largely upholding the injunction previously granted in the infringement ruling from the Munich Local Division (“LD”).
This decision clarifies the UPC’s approach to a number of issues. It was handed down on the same day as another CoA decision, in the Amgen v Sanofi & Regeneron dispute concerning PCSK9-inhibitor antibodies used for treating high cholesterol, in which the CoA’s first panel adopted the same guidelines for assessing inventive step. The present decision also considers the application of a proportionality test when issuing injunctive relief.
Background
This judgment is another in the long-running global patent dispute between the parties. The patent in suit EP 825 protects a “system comprising a prosthetic valve and a delivery catheter”. The dispute is focused on second generation transcatheter heart valves which Meril sells under the brand name Myval Octacor.
The infringement action was brought against Meril India and Meril Germany by Edwards before the Munich LD on 1 June 2023, the first day of UPC operations. A standalone revocation action was brought by Meril Italy in the Paris CD on 4 August 2023. In the infringement action before the Munich LD, Meril India and Meril Germany filed counterclaims for revocation on 2 November 2023. The revocation action and revocation counterclaims were later consolidated at the Paris CD. The Paris CD then upheld the patent in amended form allowing one of the auxiliary requests (Auxiliary Request II) on 19 July 2024 (see analysis here). Both parties appealed this decision.
On 15 November 2024, Edwards successfully obtained an injunction at the Munich LD against Meril India and Meril Germany in 16 UPC contracting member states for infringing EP 825. Meril was ordered to cease and desist from further infringements and recall and destroy infringing goods (see analysis here). Meril India and Meril Germany appealed that decision, with Edwards also appealing to the extent that the injunction did not extend to Romania.
Key findings / takeaways
1. Inventive step
This decision of the CoA’s first panel was handed down on the same day as the CoA’s second panel’s decision in Amgen v Sanofi & Regeneron (see analysis of that decision and, in particular, the UPC’s approach to inventive step, here). In both decisions, the panels aligned and set out what the CoA clearly intends to be the UPC’s approach to inventive step. In both decisions, the court adopted a more ‘holistic’ approach, which is more similar to the approach taken in the Germany and UK as opposed to the strict ‘problem-solution approach’ (PSA) used by the EPO.
Under this holistic approach, the CoA adopted a three stage test:
1. Identify the objective problem
The first step is to identify the objective problem of the invention. The EPO requires this to be identified by comparing the relevant claim to the closest piece of prior art, which requires an assessment of the individual features of the claim. However, the UPC takes a more holistic approach, requiring that the objective problem is established from the perspective of the skilled person, with their CGK, as at the application or priority date, by determining what the invention adds to the state of the art, looking at the claim as a whole (rather than individual features), the technical concept and the skilled person’s understanding the technical effects achieved from the claimed invention. Importantly, however, the CoA emphasised that the objective problem should not contain pointers to the claimed solution to avoid hindsight.
2. Identify a realistic starting point
The second step in assessing whether there has been an inventive step is to determine a ‘realistic starting point’ in the prior art that would have been of interest to the skilled person considering a similar underlying problem as that which the patent claimed to solve. Where there is more than one realistic starting point, then in those cases “the claimed invention must be inventive starting from each of them”.
3. Would the skilled person have arrived at the claimed solution?
Once the realistic starting point has been determined, the next step is to assess whether the skilled person would (not only ‘could’) have arrived at the claimed solution in the patent from that point. An invention would be obvious if the skilled person, who is uninventive and unimaginative, would take the next step prompted by a pointer or as a matter of routine, and arrive at the claimed invention.
The court added one criterion that was not present in Amgen, perhaps reflecting in part the different claim types, namely that for an inventive step to be present, there does not need to be an improvement in the teaching over and above that of the prior art, but inventive step may also be found if the patent claims disclose a non-obvious alternative to the solutions known in the prior art (following EPO case law).
That the CoA panels adopted the same wording for this ‘holistic’ approach demonstrates that the UPC may look to coordinate judgments in future where both judgments will look to establish the same important points of principle. Practically speaking, it pays to be aware of other hearings being heard around the same time and consider whether similar issues arise and the possibility of judgments being coordinated.
Following this three stage approach, the Court upheld the decision of the Paris CD that claim 1 Auxiliary Request II was not obvious to the skilled person starting from a realistic starting point, Levi, as there was no motivation for the skilled person to modify the frame of the valve to reach the claimed device. The court also reached the same finding using various prior art combinations cited by Meril.
2. Infringement and proportionality of injunctive relief
The decisions clarify that a test of proportionality should only be applied in exceptional circumstances when considering the grant of injunctive relief. When considering proportionality, the interests of third parties, such as patients, may also be taken into account, for example where “the infringing embodiment is the sole available treatment method or represents an improvement upon the available treatment methods, resulting in a notable enhancement of patient care”.
The Court found that Meril’s XL devices satisfied this criteria and hence exempted these devices from the injunction. The Munich LD had already acknowledged that Edwards offered no equivalent to these larger valves, but determined that Meril’s XL product should only be excluded from the scope of the injunction once a team at Edwards had approved their use. The CoA found that the availability of these products should not depend on Edwards’ approval and amended the relief to carve these products out of the scope of the injunction.
Satisfying the “exceptional circumstances” criteria is perhaps something which may be more likely to arise in cases which relate to patient care involving medical treatments and devices, and so these are the cases where individual product types may be exempted from any injunctions which are granted.
3. Application to amend the patent
The CoA held that when deciding on a subsequent request to amend the patent, that the Court must take into account if i) the amendment could have been made earlier and ii) the amendment will not unreasonably hinder the other party in the litigation. The CoA clarified that the Court of Instance has a wide margin of discretion in this respect, whereas the review of the CoA is limited (paragraph 34 of the decision). Therefore, in future cases the CoA will not be able to fully review a decision where the Court of First Instance has admitted further auxiliary requests to amend the patent, meaning the CoA is unlikely to overturn such decisions, and perhaps only in circumstances where the decision of the Court of First Instance is obviously incorrect.
4. Application to amend the claim to include Romania
Also of interest is the fact that Edwards failed to convince the CoA to allow it to extend its request for relief to include Romania. Edwards did not seek the addition of Romania immediately when it joined the UPC, the date of which had been foreseeable for months because Romania ratified the UPCA on 31 May 2024 and formally joined on 1 September 2024. Edwards sought to amend its claim to include Romania on 24 September 2024, which the court found was too late. The court also made clear that Romania would not be covered by a general request for remedies “within the territories of the [UPCA] at the time of the oral hearing”. All countries should be listed in the request.
5. Procedural point – Abuse of right claim
The CoA held that Edwards was not able to show that Meril Italy filing the revocation action before the Paris CD was an abuse of right (paragraph 32). Edwards argued Meril did so to frustrate the administration of the infringement proceedings. However, the Court held that Meril Italy had a legitimate interest in bringing the action as it was established before the commencement of the infringement action and runs Meril’s business distributing products in Italy. Therefore, this highlights that whilst the filing of a revocation action in anticipation of infringement proceedings is permissible, the UPC will look to see if there is evidence of bad faith in making the filing / if the filing is of a purely tactical nature (for example, where there are sham legal entities or where the entity does not carry out real commercial activity). Therefore, parties should continue to see parallel revocation and infringement UPC proceedings which may then be consolidated at the CoA as was the case here.
The Decision can be read here.
