Edwards deals a severe blow to Meril with regular advisors

Meril Life Science infringes Edwards Lifesciences’ important EP 3 646 825 with its current Myval Octacor Transcatheter Heart Valves, the UPC local division Munich under presiding Judge Matthias Zigann ruled on Friday (case ID: ACT_459987/2023).

EP 825 protects a system comprising a prosthetic heart valve and catheter. The dispute centers on the second generation of transcatheter heart valves, which Meril sells under the brand name Myval Octacor.

The consequences of the ruling are drastic for the Indian medical device manufacturer, as the product can no longer be sold in UPC countries. Romania is exempt as it had not yet ratified the UPC treaty at the time of the lawsuit.

The judgment applies immediately (case ID: UPC_CFI_15/2023). Edwards does not have to provide security or formally enforce the judgment. Meril must also reimburse Edwards for any damages, including interest, incurred since 17 March 2021.

In addition, the Indian company must provide information on sales since March 17 2021, as well as recall and destroy all products. However, the XL version of the heart valves that have already been registered for implantation are exempt.

Meril responds with a new product

Meril announced they will respect the legal process but also indicated that they will appeal against the decision to the UPC Court of Appeal.

When asked by JUVE Patent, a spokesperson for the company said “Meril firmly believes in the unique value and originality of the Myval Octacor THV technology, supported by extensive clinical evidence and recognized for its positive impact on patient care. We are confident that a thorough review of this case on appeal will affirm the merits of Meril’s pioneering advancements in transcatheter valve replacement technology.”

At the same time, Meril is going on the offensive with a new version of its heart valves.

“Irrespective of the UPC’s decision, Meril is proud to announce the launch of its next-generation Myval Octapro THV, which will be introduced at the upcoming London Valves 2024 conference”, says the company spokesperson. “This milestone reflects Meril’s unwavering commitment to pioneering progress in TAVR technology and delivering transformative solutions for patients and healthcare providers worldwide.”

Meril also points to its successes at the European Patent Office and other courts against the granting of patents by its competitors. In December 2023, for example, the EPO Boards of Appeal revoked Edwards Lifesciences’ EP 3 583 920, which protects a prosthetic valve frame.

Lucrative market

The market for heart valves is very lucrative and worth billions. Edwards is regarded as the absolute market leader with a share of well over 50%. The rest is shared by several companies such as Abbott and Medtronic. Meril, on the other hand, is considered to be a relatively new player in the business.

Competitors Edwards and Meril have been facing off in the European patent courts for years over heart-valve technology. Edwards took the dispute to the UPC in 2023. The company sued Meril for infringing four of it’s patents – twice at the Munich local division and the Nordic-Baltic regional division respectively. A counterclaim for infringement has also been pending at the Paris central division since July 2024.

Several Meril subsidiaries responded with counterclaims for revocation against EP 825 at the Munich local division. In August 2023, Meril Italy filed its own isolated nullity action against EP 825 with the Paris central division. Later, the Munich local division also referred the counterclaims for revocation to Paris for a joined ruling.

Paris paved way for Munich

In July, the central division handed down its first revocation ruling upholding EP 825. The central division rejected a revocation action and two counterclaims of revocation from three subsidiaries of Meril.

Following the ruling, the Munich local division was able to proceed with Edwards’ infringement action. It heard the case on 24 September 2024.

Four-strong bench

Four judges of the first panel of the Munich local division were present and decided that Meril infringes EP 825. As is always the case when the first panel of the Munich local division convenes, the presiding judge is Matthias Zigann. He and Tobias Pichlmaier are the two standard judges of Munich local division’s first panel.

Joining them are regular judge at the local division The Hague Margot Kokke and Stefan Wilhelm. The latter is involved in several proceedings between Edwards and Meril as a technically qualified judge. Wilhelm and Kokke are also involved in a second trial between the two opponents.

Wildanger couldn’t make the difference

In September, the courtroom at the Munich hearing was as crowded as it was before at the Paris hearing over the validity of EP 825. The large showing of in-house lawyers and their litigators is a testament to the intensity and importance of the dispute.

A large team of  Hogan Lovells represented Meril in the Munich court room. Düsseldorf-based partner Andreas von Falck is registered as main representative and took the lead in the hearing, with Alexander Klicznik providing support. They are also coordinating the overall dispute Europe-wide for Meril.

Roman Würtenberger, Lukas Wollenschlaeger, Beatrice Wilden and Felipe Zilly completed the Hogan Lovells team.

UK patent attorneys Jonathan Stafford and Gregory Carty-Hornsby from Marks & Clerk provided technical support. They have previously acted for Meril in EPO proceedings.

Due to the importance of the proceedings, however, Meril decided to spread the roles onto even more shoulders and brought Peter-Michael Weisse from Wildanger Kehrwald on board. He was not present in the previous proceedings and is actually considered a proven SEP and FRAND expert.

But Meril probably also appreciated his broad litigation experience. His partner Ole Dirks and counsel Eva Thörner from Wildanger were also active in the courtroom. However, even with the new set-up, Meril was not able to turn the tide.

Three firms take the win for Edwards

Edwards, on the other hand, had relied on the core team that was already present in the other proceedings. However, the team with lawyers from three firms is by no means small.

In UPC litigation, Edwards Lifesciences usually relies on three litigation firms that also litigate for the company in national cases. The team includes a UK team from Powell Gilbert led by lawyers Siddharth Kusumakar, Tessa Waldron and Bryce Matthewson.

Bird & Bird lawyer Elsa Tzschoppe is registered as main representative but partner Boris Kreye took the lead in the courtroom. Tzschoppe and Kreye are based in Munich, as are patent attorneys Bernhard Thum and Jonas Weickert from Thum IP.