Edwards stumbles against Meril as heart-valve dispute reaches the Netherlands

The latest decision in the dispute between competitors Meril Life Sciences and Edwards Lifesciences has seen the District Court of The Hague revoke the Dutch claims of an Edwards patent and reject the company's infringement claims against Meril. The two companies have been fighting for years over heart-valve technology.

The dispute between Edwards Lifesciences and Meril Life Sciences spans numerous jurisdictions and numerous patents, all of which relate to minimally invasive heart-valve technology.

Now, the District Court of The Hague in the Netherlands has found in favour of Meril, after Edwards Lifesciences brought infringement claims against its competitor. The court rejected the infringement claims and revoked the Dutch part of Edwards’ EP 3 494 930, for a ‘leaflet attachment frame for a prosthetic valve’ (case ID: C/09/630115 HA ZA 22-460) due to lack of novelty. Edwards had sought an injunction. The patent covers mounting a balloon catheter that includes an inflatable balloon, and a prosthetic aortic valve that can be expanded with a balloon.

Edwards announced that the company will appeal the decision.

Meril receives damages

Edwards had accused Indian medical technology company Meril of infringing its products via the latter’s products, the Myval TVH and the Navigator. These are an aortic valve prothesis and a delivery system for the prothesis, respectively. Meril counterclaimed for invalidity on the grounds of added matter, being implausible, and lacking inventive step.

The court found in favour of Meril and also held that Edwards had wrongly taken customs measures against its rival in the Netherlands, on the basis of EP 930. As a result, the court ordered Edwards to cease and desist from any customs measures, as well as any product seizures. It also ordered Edwards to pay Meril’s damages in relation to the customs measures that Edwards had taken.

US company Edwards Lifesciences provides the heart valves in four sizes, which can be individually adapted to patients’ physical conditions. However, Meril offers its product in a greater variation of sizes. In current proceedings, the District Court of The Hague determined that the patent claims of EP 930 lacked novelty over the prior art named ‘Lobbi’.

UPC, EPO and beyond

However, the Dutch court has taken a different approach to the EPO. In May 2022, the Opposition Division found EP 930 novel and inventive over the prior art, thus upholding it in its granted form. Meril awaits the decision of an appeal to the EPO Technical Boards of Appeal. Meril had requested that the District Court of The Hague stay proceedings while the EPO decides on the patent’s validity, but this became irrelevant given the most recent decision.

Proceedings on the merits regarding EP 930 are ongoing in Denmark, Greece, Hungary, Italy, Poland, Portugal, Slovakia, Spain and Turkey. Furthermore, there are other patent proceedings against Meril and Myval pending in the Netherlands. So far, the parties have not filed Unified Patent Court proceedings regarding the patent. However, Edwards Lifesciences has filed two UPC infringement proceedings against Meril at the Stockholm-based Nordic-Baltic division over EP 2 628 464 (case ID: ACT_459769/2023) and the local division in Munich over EP 3 646 825 (case ID: ACT_459987/2023).

The US company has also filed provisional measures against Meril at the local division in Munich over EP 3 763 331, which protects a ‘prosthetic valve crimping device’ (case ID: ACT_550921/2023).