Meril Life Sciences Pvt Ltd. / Meril Italy srl / Meril Gmbh v. Edwards Lifesciences Corporation – Court of First Instance – Paris (FR) Central Division, 19 July 2024, Case no. UPC_CFI_255/2023 & UPC_CFI_15/2023
Introduction
19 July 2024 marks the date of the first revocation decision by the UPC Paris Central Division, coming hot on the heels of the UPC’s first revocation decision by the Munich Central Division on 16 July 2024.
In the revocation action(s) filed by three Meril Life Sciences entities (collectively, “Meril”), the Paris Central Division upheld Edwards Lifesciences’ (“Edwards”) European Patent EP 3 646 825 B1 (“EP’825”) protecting a prosthetic heart valve system having a sealing mechanism to prevent or minimize perivalvular leakage, albeit in amended form.
From Munich to Paris to Munich again
On 1 June 2023, the day of the opening of the UPC, Edwards filed an infringement action against Meril GmbH and Meril Life Sciences Pvt Ltd. before the Munich Local Division. In response, on 4 August 2023, Meril Italy Srl filed a revocation action against EP‘825 before the Paris Central Division, and subsequently, Meril GmbH and Meril Life Sciences Pvt Ltd filed separate, but identical, counterclaims for revocation of the patent on 2 November 2023 in the infringement action brought against them before the Munich Local Division.
The Paris Central Division previously held that it was competent to handle the revocation action, as the Meril entities did not qualify as the “same parties” and Article 33(4) UPCA was, therefore, not applicable. More so, as the (counter)claims for revocation were founded on similar grounds, the Munich Local Division decided to refer the counterclaims for revocation to the Paris Central Division for decision pursuant to Article 33(3)(b) UPCA and 37(2) RoP.
Consolidated proceedings
The Paris Central Division had to decide whether to consolidate the revocation action and revocation counterclaims, and provided some useful guidance as to the approach the court should take. It said that decisions regarding consolidation should be made on a case-by-case basis, and should take into account the principle of efficiency of the proceedings, which may be undermined by unnecessary procedural activities, duplication of those activities and the risk of irreconcilable judgments. The court should also weigh up the interest in issuing expeditious decisions which are important for legal certainty. The potential time difference between decisions of the different divisions involved in the proceedings, and similarity of grounds of invalidity, are also relevant.
In this case, the court rejected Edwards’ request to consolidate the proceedings before the Munich Local Division due to the competence of the Central Division pursuant to Article 33(4) UPCA. The court also dismissed the suggestion by the Munich Local Division that Rule 340 RoP should be interpreted as requiring a joint hearing involving judges from both Local and Central Divisions.
On the facts, the Paris Central Division therefore consolidated the revocation action and revocation counterclaims. However, it noted that this does not result in a true merger of the claims, which retain distinct legal identities and must be adjudicated independently, even if, as was the case here, a single decision is ultimately issued.
The battle for amendments
Faced with the claims for revocation, Edwards initially filed an application to amend the patent based on 9 conditional amendments and 84 auxiliary requests with its defence. The judge-rapporteur however rejected the application, stating that it was not appropriate to address the issue during the written procedure, and deferred it to the oral hearing. A second request to amend the patent, consisting of 41 auxiliary requests based on 9 individual amendments, was moreover rejected as not reasonably justified due to the rejection of the first application. The UPC Court of Appeal denied Edwards’ request for a discretionary review of this order. Finally, after closure of the written procedure and following an interim conference, Edwards filed a further request to amend the patent, proposing one unconditional amendment and six auxiliary requests, which was admitted into the proceedings based on the following reasoning.
Before the Paris Central Division, Edwards claimed that the initial application for amendment of the claims should have also been granted, to which the court agreed. Indeed, while the division considered the number of the amendments originally filed in the statement of defence to be extremely high, potentially hindering the efficiency of the UPC proceedings and the goal of delivering expeditious decisions, it did not appear that that number was “unreasonable”, considering the extreme complexity of the case – in particular, the number of grounds of invalidity raised – the importance of the patent at issue and the interrelationship with other proceedings, both judicial and administrative, concerning related patents of the same family. The lack of a consistent interpretation of the expression “reasonable in number” in Rule 30(2) RoP also suggested a less strict interpretation of the provision.
Claim 1 as amended in the second auxiliary request now in essence protects a prosthetic heart valve comprising a collapsable and expandable annular frame for mounting on a delivery apparatus, wherein the frame is made up entirely of hexagonal cells, and wherein each of the hexagonal shaped cells is defined by six struts designed in a specific way.
Claim interpretation
There is a growing body of UPC case law – including this decision – which approves the approach to claim construction set out by the UPC Court of Appeal in the 10x Genomics v NanoString decision (case UPC_CoA_335/2023), based on Article 69 of the European Patent Convention (EPC) and the Protocol of Interpretation. The Paris Central Division specifically noted that the claim is not only the starting point, but is the decisive basis for determining the protective scope of the patent. It went on to say that the interpretation of a claim does not depend solely on the strict, literal meaning of the wording used, as the description and the drawings must always be used as explanatory aids for the interpretation of the patent claim, but this does not mean that the patent claim serves only as a guideline and that its subject-matter may extend to what, from a consideration of the description and drawings, the patent proprietor has contemplated.
However, this approach may be influenced by recent legal developments relating to claim construction and the interpretation of Article 69 EPC at the European Patent Office (EPO). A referral requesting clarification on how and when the description and the drawings in a patent can aid the interpretation of its claims was made to the Enlarged Board of Appeal (EBA) at the EPO earlier this year in Case G1/24. It will be interesting to see what impact the EBA’s guidance in Case G1/24 will have on the UPC’s own decision-making.
The battle for revocation
Priority
As a result of the amendments, Meril had good reason to question the validity of the priority right on which EP’825 relied. An argument for invalid transfer of priority based on the EPO EBA G1/22 and G2/22 decision – which established a rebuttable presumption of the entitlement to priority – however failed. The court said that Edwards had not provided any evidence that the priority rights were the subject of a separate dispositive act in favour of third parties, or that the original applicants intended to retain the priority rights instead of transferring them along with the rights to the title, which may have rebutted the presumption.
Nevertheless, the Central Division concluded that the subject-matter of claim 1 was no longer directly and unambiguously derivable from the priority document. For instance, the priority document merely disclosed a frame made of “a plurality of hexagonal or ‘honeycomb’ shaped cells” instead of a frame made up entirely of hexagonal cells, as claimed since the amendments. Therefore, the patent could no longer claim the earlier priority date.
Inventive step
Luckily for Edwards however, Meril’s novelty and inventive step arguments failed to convince the Paris Central Division on the invalidity of the patent. While the use of hexagonal cells was known in the field of heart valve technology, the total elimination of rhombic cells in favour of an all-hexagonal frame structure was novel in the light of the state of the art and reflected an inventive step not obvious to the skilled person.
Regarding inventive step, it is noteworthy that the panel did not apply the problem-solution approach which is used by the EPO and by some national courts, but did acknowledge that such an application exists. The panel correctly stated that the EPC does not mandate the application of the problem-solution approach and that it is as such not bound by it, and furthermore that an application of it would not have led to a different outcome of the proceedings either. The Central Division rather took a holistic approach to dealing with the arguments put forward by Meril.
The panel disagreed with Meril that the combination of features in claim 1 of the auxiliary request lacked any technical effect over the prior art. Meril argued that the mere fact of having a frame entirely made up of hexagonal cells was not sufficient to achieve the technical effects of a reduced crimping profile and increased stability and radial strength during crimping and expansion, as other parameters might also have an effect. According to the panel, the burden was on Meril to provide evidence to prove such an alleged lack of technical effect. However, the panel found the reference to the submitted expert evidence to be generic, as it failed to refer to any specific passage therein, and moreover disagreed with the statement in the expert declaration that if a feature would not be sufficient for achieving a specific technical effect that would mean that the feature is not relevant at all.
The court went on to conclude that EP’825 did not disclose an obvious alternative solution to the technical problem over the prior art. In its assessment, the division did not find it relevant to determine the closest prior art, but merely stated that it was “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.” In this case, while the prior art made use of hexagonal shapes in their heart valves or vascular stents, as considered by the panel as two separate but adjacent technical fields in this case, the prior art either deliberately chose to also use intermediate rhombic cells in order to provide structure to the frame, was aimed at addressing a different technical problem or did not provide any motivation to alter the geometry of the frame as claimed.
Final remarks
We expect to see the UPC’s approach to inventive step to evolve as more decisions on the merits are handed down. In its decision in 10x Genomics v NanoString (case UPC_CoA_335/2023), the UPC Court of Appeal neither approved nor criticised the problem-solution approach. In their first decisions on the merits, the Düsseldorf Local Division (Kaldewei v Bette case UPC_CFI_7/203) and Paris Local Division (Dexcom v Abbott case UPC_CFI_233/2023) appear to have adopted tests which are akin to the problem-solution approach (although not as strict). In the UPC’s first revocation decision, the Munich Central Division appeared to take a more holistic approach that is not an EPO-based problem-solution approach, but neither is it entirely inconsistent with it. In the present case, the Paris Central Division did not apply the EPO’s problem-solution approach and seems to have made a clear statement as to its – or at least this panel’s – views as to the application of the test. It is surely only a matter of time before this matter comes before the Court of Appeal for clarification.
It is likely that Meril will appeal the decision. Meanwhile, the infringement action still remains with the Munich Local Division, which may resume once more.
The full order can be read here.
