UPC Court of Appeal on Territorial Scope, Late Claim Amendments & Proportionality of Injunctions in a Life Sciences Dispute

In its decision of 25 November 2025 in Edwards Lifesciences vs. Meril (APL_2205/2025), the UPC Court of Appeal addressed procedural discipline in framing remedies (especially territorial scope) and refined how proportionality may shape injunctive relief in a medical-device case. The decision forms part of a combined judgment in the wider Meril v Edwards / Edwards v Meril appeals package.

In its decision, the UPC Court of Appeal confirms a disciplined approach to pleading the territorial scope of remedies, a stringent application of Rule 263.2 RoP to late claim amendments, and a structured proportionality analysis that can accommodate patient-interest exceptions through enforceable, objective conditions.

Background

The underlying proceedings concerned infringement and validity disputes relating to a European patent for a balloon-expandable transcatheter prosthetic heart valve system. On appeal, Edwards challenged aspects of the Munich Local Division’s infringement decision, including how the requested territorial scope of the injunction had been formulated and the refusal to add Romania at a late stage. Meril, for its part, pursued (inter alia) changes to the injunction and corrective measures for certain valve sizes on proportionality grounds linked to patient interests.

Key findings of the decision

1. Territorial scope must be pleaded with clarity
Edwards’ main request sought an injunction applying “within the territory of the [UPCA] at the time of the oral hearing”, without listing the relevant Member States. The Court of Appeal upheld the dismissal of that request for lack of clarity. It held that it is for the claimant to define the geographical scope of the relief sought and that, as a general rule, this requires listing the countries concerned so that defendants, the Court and enforcement authorities can determine scope “unambiguously and without further research”.

2. Late addition of Romania refused under Rule 263.2 RoP
Edwards’ attempt to add Romania to the list of countries covered by its auxiliary request was rejected. Applying Rule 263.2 RoP, the Court found Edwards had not shown that the amendment could not have been made earlier with reasonable diligence, and further noted the late change unreasonably hindered Meril’s ability to prepare its defence. The Court referred to the publicly known timetable of Romania’s UPCA accession and Edwards’ delay until the oral hearing.

3. Proportionality and third-party interests can shape injunctive relief
On the merits of injunctive relief, the Court reiterated that, in principle, a finding of infringement should lead to an order prohibiting continuation unless there are special reasons, notably linked to proportionality under the Enforcement Directive framework. The Court confirmed that proportionality may require consideration of third-party interests such as patients, and accepted that exceptions may be justified where an infringing embodiment is the sole available treatment method or yields a notable enhancement of patient care.
Applying this to Meril’s XL devices, the Court considered that reliance on Edwards’ “Medical Request Portal” was not an adequate mechanism: access to the XL devices should not depend on the patentee’s continued operation of a portal or its internal assessment. The Court therefore amended the injunction and corrective measures so that a physician notification confirming the XL device as the only available treatment option would suffice.

Analysis and implications

For UPC litigants, the decision underscores two practical points grounded in the Court’s reasoning. First, relief must be pleaded with operational precision: territorial scope should normally be enumerated by country, rather than defined by reference to fluctuating membership at a procedural date. Second, Rule 263.2 RoP is applied strictly where a claimant seeks to expand territorial reach late in the proceedings; public and foreseeable changes in UPCA membership will not readily excuse delay.

On remedies, the decision illustrates that proportionality is not a purely bilateral inquiry. The Court accepted that patient access considerations can justify calibrated exceptions, while still maintaining injunctive relief in principle, and it required a mechanism independent of the patentee’s discretion for medically justified use cases.

Source: Case law | V.O. Patents & Trademarks