Meril Italy v Edwards Lifesciences (UPC_CFI_255/2023 and UPC_CFI_15/2023)
Decision date:
19 July 2024
Osborne Clarke summary
- Meril's revocation action against Edwards Lifesciences relating to its patent concerning a prosthetic heart valve (EP 825) was rejected. Meril had separately filed counterclaims for revocation in an infringement action brought against them by Edwards Lifesciences in the Munich LD. The Munich LD decided that the counterclaims raised similar grounds of invalidity to the revocation action and, as such, ordered that the counterclaims be referred to the Paris CD for determination pursuant to Article 33(3)(b) UPCA.
- Meril alleged that the patent was invalid for several reasons: extension of subject matter beyond the application originally filed (Edwards Lifesciences had filed an application to amend its patent with its defence to revocation), lack of enabling disclosure, lack of novelty and lack of inventive step.
- In considering inventive step, the Paris CD carried out its assessment in accordance with Article 56 EPC, noting that it is "necessary to determine whether, given the state of the art, a person skilled in the art would have arrived at the technical solution claimed by the patent using their technical knowledge and carrying out simple operations. Inventive step is assessed in terms of the specific problem encountered by the person skilled in the art".
- In this case, although hexagonal cells were disclosed in the prior art at the time of the application, they were only used in combination with (intermediate) rhombic cells. The court found that the mere use of hexagonal cells in the frame of a heart valve did not lead to the conclusion that it would be obvious to the skilled person to employ a frame entirely made of hexagonal cells to address the problem. Thus, it concluded that the prior art teachings on heart valves and the structure of their frame would not have provided any motivation for the skilled person to alter the shape of (some of) the cells to an all-hexagonal configuration.
- The Paris CD also considered prior art in the stent field relating to hexagonal cells, as Meril had pointed out that catheter-based prosthetic valves were developed by combining the technology of valves with leaflets with the frame technology used in vascular stents. Even considering this, the Paris CD held that it would not be obvious to the skilled person versed in both technologies to solve the technical problem.
- As a final remark, the Paris CD stated that the EPO problem-solution approach (finding the closest prior art, defining the technical problem and considering whether the claimed invention, starting from the closest prior art and the technical problem, would have been obvious to the skilled person) was not mandatory. Indeed, the court did not apply it here; however, it noted that applying the problem-solution approach would not have produced a different outcome in this case.
- In considering added matter, the Paris CD stated that a European divisional patent application may only be filed with respect to subject matter that does not extend beyond the content of the earlier filed application. Such an extension can occur if the subject matter cannot be directly and unambiguously made out from the earlier application by the skilled person. An undue extension may result from an amendment to the claims or description that consist of an "intermediate generalisation". The Paris CD defined intermediate generalisation as “extracting one or more isolated features which, in the initial application, were disclosed only in combination with other features, thereby extending the claimed subject matter, which is no longer limited to this initial combination of features”. The court had found added matter with regard to the intermediate generalisation of a feature (1.5) as a result of the omission of a complete definition. However, Edwards Lifesciences' second auxiliary request overcame the issue.
Issue
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