In a detailed decision issued on 4 April 2025 in case UPC_CFI_501/2023, the Local Division Munich granted broad relief for Edwards Lifesciences Corporation against Meril Life Sciences Pvt Ltd and its European subsidiaries based on European Patent EP 3 669 828 B2 concerning a transcatheter prosthetic heart valve. The Court rejected Meril’s preliminary objections and counterclaim for revocation and upheld the patent in the form maintained by the EPO's Opposition Division. The judgment demonstrates the Division’s alignment with EPO jurisprudence on the assessment of inventive step and offers significant guidance on claim construction and group infringement under Art. 33(1)(b) UPCA.
The Court confirmed that the problem-solution approach, as developed by the EPO, is the primary method to assess inventive step under Art. 56 EPC. Emphasising legal certainty and consistency with the case law of the Boards of Appeal, the Division methodically applied this approach when evaluating Meril’s invalidity arguments.
A realistic starting point was identified, and the technical problem - achieving a heart valve with a smaller crimped profile while ensuring reliability and longevity - was formulated in light of the distinguishing features. The solution, namely the specific folding configuration of the secondary leaflet tabs around both radially and axially extending creases, was not found to be obvious to the skilled person.
This decision aligns with the UPC's stated objective in the Preamble to the UPCA of promoting uniform interpretation of substantive patent law. The Court’s clear endorsement of the problem-solution approach also signals a convergence with established EPO practice - a welcome clarification for users dealing with parallel EPO and UPC litigation.
This Munich decision complements recent developments in UPC case law addressing validity and infringement. In Plant-e Knowledge v. Arkyne (UPC_CFI_177/2023), the Local Division The Hague issued the UPC’s first detailed decision on infringement by equivalence, finding infringement despite literal differences. Regarding inventive step, the problem solution approach was used. It is worth noting, though, that other divisions of the UPC - such as the Munich seat of the Central Division in Amgen v. Sanofi (UPC_CFI_1/2023) and the Paris seat of the Central Division in Meril v. Edwards (UPC_CFI_255/2023) - have refrained from applying the problem-solution approach. Elsewhere, divisions have drawn inspiration from the EPO’s approach but applied it with less rigour.
In any event, there appears to be agreement among the Divisions that any realistic starting point may be used. It does not seem to be required, according to current UPC practice, to identify the closest prior art. Note: In my view, applying the problem-solution approach without the requirement to start from the closest prior art largely mirrors the German approach...
The Local Division also addressed the issue of jurisdiction with respect to multiple defendants. Meril challenged the jurisdiction of the Munich Division over Meril Italy. The Court, however, held that the requirements of Art. 33(1)(b) UPCA were satisfied. The defendants, forming a group of companies, were alleged to have committed the same infringement through the same product across several national designations of the patent. The Court explicitly noted that interpreting “the same infringement” narrowly in the context of a European patent without unitary effect would undermine the objectives of the UPCA.
A notable procedural clarification was made in relation to cease-and-desist declarations. The Court held that declarations lacking a penalty clause, especially when only issued by some but not all members of an infringing corporate group, are not equivalent to enforceable court orders. The risk remains that the group could reorganise operations and continue the infringing acts under the protection of such non-binding undertakings.
The Court confirmed that where a decision is immediately enforceable under Rule 354.1 RoP, no security needs to be lodged under Rule 118.2(a) RoP. Nevertheless, Rule 118.8 RoP remains applicable.
Cease-and-desist declarations without a penalty clause are insufficient in cases of coordinated group infringement, particularly where enforcement risk persists.
The decision adds to a growing body of UPC case law that interprets the UPCA in light of its preamble objective - overcoming fragmentation in European patent enforcement.
