Meril Life Sciences Pvt Limited and Others v. Edwards Lifesciences Corporation

Edwards Lifesciences Corporation, the proprietor of European patent EP 3 769 722 relating to a low profile delivery system for transcatheter heart valve, brought an infringement action against Meril Life Sciences Pvt Limited and five related entities (Meril GmbH, SMIS International OÜ, Sormedica UAB, Interlux UAB, and VAB-Logistik UAB) before the Nordic-Baltic Regional Division of the Court of First Instance on 27 October 2023. On 7 March 2024, the firm of JA Kemp filed an opposition against the patent at the European Patent Office (EPO). The EPO issued a preliminary non-binding opinion on 18 July 2024 stating that the grounds for opposition prejudice the maintenance of the patent in its granted form, and accelerated the opposition proceedings with an oral hearing scheduled for 17 January 2025. On 18 March 2024, Meril filed counterclaims for revocation of the patent in the infringement proceedings and also applied to stay the infringement proceedings pending the EPO Opposition Division's decision. Edwards opposed the stay. On 20 August 2024, the Court of First Instance rejected Meril's stay request, reasoning primarily that because the EPO Opposition Division's decision would likely be appealed, a final decision could not be expected rapidly, and that the UPC could be expected to decide on validity before the opposition proceedings were finalized. Meril appealed.

On appeal, Meril argued that the Court of First Instance erred in its interpretation of Art. 33(10) UPCA and R. 295(a) RoP, which do not require that a final EPO decision be expected rapidly, but only that a rapid decision from the Opposition Division may be expected. Edwards argued that the Court of First Instance's decision was within its discretion and that a stay was not warranted given the advanced stage of the infringement proceedings.

The Court of Appeal addressed several legal points. First, it held that R. 222.2 RoP, which allows the Court of Appeal to disregard requests, facts, and evidence not submitted before the Court of First Instance, does not prevent a party from submitting new legal arguments on appeal, provided they are based on facts and evidence already submitted. Second, the Court clarified the framework for stays pending EPO opposition proceedings: R. 118.2(b) and R. 295(g) RoP apply when the case is ready for a decision on the merits, while R. 295(a) RoP governs stays prior to that stage. Third, the Court held that Art. 33(10) UPCA and R. 295(a) RoP do not require that a final EPO decision be expected rapidly; the Court may stay proceedings where a rapid decision from the Opposition Division can be expected, even if that decision is likely to be appealed. Fourth, the Court emphasized that a stay under these provisions is discretionary, depending on the balance of interests and specific circumstances, including the stage of the opposition and infringement proceedings and the likelihood of revocation. The Court also noted that stays serve to prevent conflicts between infringement decisions and EPO opposition decisions, particularly where the EPO revokes a patent that formed the basis for a Court order.

Applying these principles, the Court of Appeal found that the Court of First Instance erred by refusing the stay solely on the basis that a final EPO decision could not be expected rapidly. The Court of Appeal found that a rapid decision by the EPO Opposition Division could indeed be expected, as the oral hearing was scheduled for one day after the infringement proceedings oral hearing. However, the Court of Appeal also noted that there are alternative ways to prevent conflicting decisions without ordering a stay at this stage, such as proceeding with preparations and rescheduling the oral hearing, holding the hearing as scheduled and then deciding on further steps based on the EPO outcome, or proceeding and exercising powers under R. 118.2(b) RoP when issuing the decision on the merits. Given the Court of First Instance's better-informed position regarding the infringement proceedings and counterclaims for revocation, the Court of Appeal set aside the impugned order and referred the case back to the panel of the Court of First Instance for further consideration of the stay request. The Court of Appeal did not decide on costs, as the order was not a final order concluding the infringement action.