In Meril v. Edwards, the Court of Appeal (CoA) of the (European) Unified Patent Court held that permanent injunctions can be withheld when interests of patients are taken into account

In a November 25, 2025 decision in the case of Meril v. Edwards, the Court of Appeal (CoA) of the (European) Unified Patent Court held that permanent injunctions can be withheld when interests of patients are taken into account.

Paragraphs 14, 15 and 16 of the decision clarify the relationship between the UPC Agreement (UPCA) and the EU Enforcement Directive (2004/48/EC). Specifically, addressing the proportionality defense to an injunction.

Paragraph 15 states that while the Court must generally issue an injunction upon finding infringement, a “special reason” for denying or limiting that injunction may exist if the remedy would violate Article 3 of the Enforcement Directive.

Article 3 of the EU Enforcement Directive sets out general obligations on Member States when providing for “the measures, procedures and remedies necessary to ensure the enforcement of the intellectual property rights.“ Paragraph 2 of Article 3 requires that those measures be proportionate, dissuasive, and “avoid the creation of barriers to legitimate trade and to provide for safeguards against their abuse.”

Paragraph 16 of the decision states that “the interests of third parties, such as patients, may be taken into account.”

In the Meril v. Edwards dispute, Court used this interpretation of Article 3 to justify a public health carve-out. Because the patent in suit (EP 825) involves life-saving transcatheter heart valves, the Court found that a “blanket” injunction would be disproportionate, noting that where Meril’s infringing device was the only clinically viable option for a specific patient group (where Edwards’ product might not fit or be suitable), then blocking that device would harm third-party interests (patients’ lives) and violate the proportionality requirement of Article 3.

Decision of the Court of Appeal of the Unified Patent Court concerning EP 3 646 825
issued on 25 November 2025

Permanent injunctions
14. Where the proprietor files an infringement action and the Court finds that an intellectual property right has been infringed or is threatened to be infringed, it shall issue an order prohibiting the continuation of the infringement unless there are special reasons for not doing so.

15. A special reason for denying an injunction may apply if, in the circumstances of the particular case, granting an injunction does not comply with the general obligations of Art. 3 of the Enforcement Directive, in particular the obligation that the remedies shall be proportionate.

16. When considering the proportionality of injunctive relief and corrective measures, not only the interests of the parties to the litigation but also the interests of third parties, such as patients, may be taken into account.

The decision weighed a number of issues regarding the extent to which the infringing devices would impact the interests of patients, before providing a narrow exception to the injunction against Meril for specific cases.

Sarah Taylor and Vural Ergisi describe the outcome regarding the injunction as follows:

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.

The following paragraphs are from the Court of Appeal’s decision:

192. Meril India and Meril Germany offer valve prostheses in different sizes than the other manufacturers, such as Edwards. They argue that the availability of these different sizes is crucial from a clinical standpoint, as it permits the selection of an appropriate model tailored to the individual patient’s needs. The Munich Local Division held that this argument has merit in respect of Meril’s XL devices (30.5 mm and 32 mm for the Myval Octacor and 30,5 mm x 35 mm and 32 mm x 35 mm for the Navigator Inception), but not in respect of Meril’s intermediate-sized products (sizes 21.5, 24.5 and 27.5 mm), which are recommended for native valve annulus sizes of 17.5-20.5, 19.5-23.5 and 22.5-26.5 mm. Edwards’ products are indicated for native valve annulus sizes in the same ranges. The Munich Local Division established that, compared to these products, Meril’s intermediate-sized valve prostheses do not result in a notable enhancement of patient care. It observed that Meril does not have data to support its contention that the infringing embodiment is superior and that a “LANDMARK” clinical trial sponsored by Meril India did not even show that it is non-inferior to Edwards’ products (Exhibit K-B1). It also referred to a TCT conference presentation (Exhibit K94), which according to the Munich Local Division shows that the infringing embodiments perform worse than the Edwards valves in many respects and refutes the contention of Meril India and Meril Germany that their intermediate-sized products reduce the risk of valve leakage and the need for subsequent pacemaker implantation.

193. Meril India and Meril Germany failed to demonstrate that the findings of the Munich Local Division on the lack of an enhancement of patient care are incorrect. They reiterated their assertion that the availability of different models assists the treating physician when implanting a heart valve and reduces the risk of mal-implantation and over- and under-expansion. However, they did not contest that they do not have data to support the superiority of their intermediate-sized valves, that their LANDMARK study does not show such superiority, or that the TCT conference presentation shows that Meril’s prostheses actually perform worse and instead refutes the alleged risks of using Edwards’ products. They only refer to a recently published comparison of the Myval-THV-series with the Sapien-THV-series (Exhibit HLAppeal 7) but failed to draw any conclusions from this publication and did not show that this publication does support their assertions.

194. As far as Meril’s XL devices are concerned, the Munich Local Division acknowledged a legitimate interest in their availability. It established that there may be patients who can only be adequately treated with Meril’s XL devices, in view of inter alia the fact that Edwards’ products are not recommended for native annulus sizes of more than 28 mm. It therefore exempted XL devices that were scheduled for implementation in an individualized patient by 15 November 2024 from the injunction and the corrective measures. This part of the judgment is not challenged on appeal.

195. In respect of XL devices not scheduled for implementation, the Munich Local Division held that the interest in their availability is adequately addressed through Edwards’ Medical Request Portal. Via this online portal, practitioners can upload relevant patient data. A team of doctors at Edwards review the data and determine whether use of Edwards’ product is an option. If the doctors find that using Edwards’ products is not an option, Edwards will grant an exception to the injunction.

196. The Court of Appeal agrees with Meril India and Meril Germany that Edwards’ portal does not adequately address the legitimate interest in the availability of Meril’s XL devices. The availability of these products should not depend on the willingness of Edwards to maintain the portal or on the assessment by Edwards’ team of doctors. A notification of an intention to use Meril’s XL device by a physician confirming that such product is the only available treatment option for a particular patient should be sufficient. The Court of Appeal will therefore amend the injunction and orders for corrective measures accordingly and maintain them on the basis of an auxiliary request which the parties have drafted in common accord during the oral hearing in the appeal proceedings.

197. Under the amended orders, the making, offering, placing on the market and use of Meril’s XL devices, and the importing and storing of the products for those purposes, are not covered by the injunction and corrective measures, provided that a physician has submitted the required notification. Contrary to the concerns put forward by Meril India and Meril Germany, this implies that the injunction does not prohibit them from making doctors aware of the availability of the XL devices where it is the only treatment option for a particular patient.

198. The complaints by Meril India and Meril Germany about the findings of the Munich Local Division on their willingness to obtain a licence can remain undecided. The findings were not decisive for the Court’s decision to grant the injunction and the corrective measures. Although the Munich Local Division regarded Meril India and Meril Germany as unwilling licensees, it examined the interests in the availability of the valves. To the extent that it denied the requested exemption, the decision is based on the lack of notable enhancement of patient care, not the unwillingness to take a licence.

Conclusion

220. It follows that the appeals against the impugned revocation decision, claim amendment order and competence order must be rejected. Edwards’ appeal against the impugned infringement decision is not successful either. The appeal by Meril India and Meril Germany against the impugned infringement decision must be rejected, except for the grant of the injunction and corrective measures regarding XL devices that had not already been scheduled for implementation and the order to pay interim damages in the amount of € 663,000. The Court of Appeal will set aside that latter part of the impugned infringement decision and uphold the remainder of the decision. It will grant the injunction and corrective measures regarding XL devices that had not already been scheduled for implementation in an individual patient by 15 November 2025 in amended form. It will order an interim award of costs in the amount of € 363,000. For reasons of efficiency, it will do so by setting aside the impugned infringement decision to the extent that Meril India and Meril Germany were ordered to pay preliminary damages of more than € 363,000. In the appeals by Edwards and by Meril India and Meril Germany against the impugned infringement decision (UPC_CoA_27/2025 APL_2205/2025 and UPC_CoA_21/2025 APL_1926/2025) IX. The impugned infringement decision is set aside to the extent that the orders sub I, V, and VI extend to XL devices (30,5 mm and 32 mm) that have not been scheduled for implantation in an individual patient by 15 November 2024 and that Meril India and Meril Germany were ordered to pay
preliminary damages in the amount of more than € 363,000;

DECISION
. . .

In the appeals by Edwards and by Meril India and Meril Germany against the impugned infringement decision (UPC_CoA_27/2025 APL_2205/2025 and UPC_CoA_21/2025 APL_1926/2025)

. . .

X. The orders sub I, V, and VI of the impugned infringement decision do not extend to XL devices that have been the subject of a notification of an intention to use by a physician confirming that the XL device is the only available treatment option for a particular patient in the Medical Request Portal, which Edwards has confirmed will remain operational for the XL devices, or otherwise such a notification is made in writing to Edwards should the Medical Request Portal not be available;

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