The Paris seat of the Central Division delivered a comprehensive judgment in a dispute between Edwards Lifesciences and Meril Life Sciences concerning EP 4 151 181 B1 on transcatheter prosthetic heart valves. The Court addressed multiple aspects — from added matter and novelty to inventive step, proportionality of injunctions, and public-interest exceptions.
The Court explained that inventive step must be assessed through a three-step sequence (dear EPO practitioners: please note the order of steps 1 and 2 !):
(1) identification of the objective technical problem,
(2) selection of realistic starting points, and
(3) evaluation whether it would have been obvious for the skilled person to arrive at the claimed solution.
Clearly diverging from the EPO’s problem-solution approach, the Court described its reasoning as a holistic assessment — meaning that non-obviousness is to be considered for the invention as a whole, not through a purely feature-by-feature comparison. The decision explicitly aligned its reasoning with earlier UPC case law (UPC_CoA_335/2023, UPC_CoA_382/2024, UPC_CoA_768/2024; CD Paris UPC_CFI_311/2023).
Just focusing upon isolated distinguishing features dose not appear – to the CD Paris – to appropriate. Further, the CD Paris added that the problem should be identified in an abstract and neutral way as to avoid the risk of hindsight.
The Court confirmed that the filing of 17 auxiliary requests was not “unreasonable” under Rule 30 RoP, given the case’s complexity and the number of validity attacks. The Central Division again emphasised the absence of any explicit sanction for exceeding a “reasonable number” and endorsed the pragmatic approach already seen in CD Paris 309/2023 and LD Munich 526/2024 — namely, examining requests sequentially until a reasonable number is reached.
The CD Paris found that labelling a valve as a heart valve conveys positive technical constraints (e.g., dimensions, materials, suitability for implantation in the heart) – and dropping the “heart” part amounted to an unallowable intermediate generalisation under Art. 76(1) EPC. Interestingly, the EPO Opposition Division – at least in their preliminary option – was more generous and noted the “heart” part of the “heart valve” adds no technical limitation and that the generic reference to “prosthetic valves” in para. [007] could support the claim.
The Court restated that an injunction under Art. 63 UPCA is the general rule once infringement is established, but that it may be refused or tailored where enforcement would be disproportionate or unreasonably detrimental to the public interest. The reasoning closely follows the approach of the Munich Local Division’s decision of 15 November 2024 (UPC_CFI_15/2023).
Meril had argued that an injunction would limit treatment options for aortic-valve stenosis and impede research on its Octacor and Octapro systems, which are available in unique intermediate and XL sizes. The Court accepted that a genuine public-health interest exists only for XL-size valves – those exceeding 30 mm in diameter – since these are the only currently approved devices suitable for patients with such large annuli.
Consequently, the injunction was limited: all infringing acts were prohibited except those involving XL-size valves and their delivery apparatus, until another equivalent treatment becomes available. The Court rejected the idea of routing such use through Edwards’ “Medical Request Portal”, holding that patient access must not depend on competitor authorisation.
