Paris central division upholds Edwards patent in heart-valve saga

The judgment concerns Edwards Lifesciences’ EP 4 151 181, one of several patents-in-suit that the US medical devices company is defending against Meril Life Science at the UPC.

The Indian competitor had filed a revocation claim against EP 181 at the central division in Paris, to which Edwards Lifesciences responded with a counterclaim for infringement. The patent holder accused Meril of infringing the patent with its Octacor and Octapro heart-valve systems.

The UPC has now maintained EP 181 in amended form and ruled that Meril’s products infringe several claims of the amended patent. The panel, consisting of presiding judge Paolo Catallozzi, legally qualified judge Tatyana Zhilova and technically qualified judge Elisabetta Papa, banned Meril from selling its infringing Octacor THV and Octapro THV devices in UPC member states where the patent is in force. However, they exempted prosthetic heart valves in XL size exceeding 30mm in diameter and related delivery apparatus due to public health interests (case IDs: UPC_CFI_189-2024 and UPC_CFI_434-2024). JUVE Patent does not yet know whether Meril will appeal the decision.

Opposition proceedings against EP 181 are pending at the EPO, initiated by Meril. According to the register, the hearing is scheduled for today. In a preliminary opinion, the Opposition Division acknowledged novelty of claim 1. The UPC included this opinion in its considerations.

However, the Paris central division considered that the definition of “slack” as implying excess material is disclosed in the patent and consistent with the general meaning of the term. According to the court, the EPO’s reasoning does not hold if it accepts that “slack” means only excess material.

One of the first

The series of proceedings between the two opposing parties is one of the largest and oldest at the UPC. The parties filed all actions in the first few months following the court’s launch. These followed proceedings at national courts concerning other patents. While many major UPC proceedings from the early days have now been settled, such as Panasonic vs Xiaomi and Oppo, Abbott vs Dexcom and 10xGenomics vs NanoString/Bruker, the dispute between Edwards and Meril is ongoing.

The UPC proceedings centre on Meril’s transcatheter heart valves (THV) Myval, Octacor and Octapro as well as the delivery system Navigator. Edwards argues these products infringe several of its patents and sued Meril twice for patent infringement at the Munich local division and the Nordic-Baltic regional division in Stockholm. In return, Meril lodged counterclaims for revocation in Munich and revocation actions at the local division Paris.

The infringement actions that Edwards Lifesciences filed at the Nordic-Baltic division concern EP 3 769 722, regarding Meril’s Navigator delivery system, and EP 2 628 464. This July, the Nordic-Baltic division upheld EP 722 in amended form and found Meril had infringed (case ID: UPC_CFI_380/2023). Meril did not appeal the decision.

Previously the parties had reached a settlement in parallel proceedings before the Nordic-Baltic division concerning EP 464 (case ID: UPC_CFI_8/2023).

Isolated nullity case

The infringement dispute at the Munich local division over EP 3 646 825, which Edwards claims Meril infringed with its Octacor THV device, was particularly fierce. Meril responded by filing a counterclaim for revocation.

However, prior to filing the counterclaim, a different subsidiary Meril Italy filed its own isolated nullity action against EP 825 with the Paris central division in August 2023.

In November 2023, the Paris central division ruled that Meril Italy’s revocation action is admissible. According to the court, a wholly owned subsidiary can file a separate nullity action at the UPC, even if an infringement and nullity case involving the parent company are already pending at another UPC division.

Later, the Munich local division referred the counterclaims for revocation from the German and Indian Meril subsidiaries to Paris. The Paris court heard all revocation attacks against Edwards’ EP 825 together.

First ruling from Paris

In mid-2024 the central division Paris, in its first ruling since the launch of the UPC, upheld EP 825 in the revocation action. Following the ruling, the Munich local division then proceeded with Edwards’ infringement action. In autumn 2024 the panel around presiding judge Matthias Zigann ruled that Meril infringes EP 825 with its Octacore THV device.

Meril appealed both the decision of the Paris central division in the revocation action as well as the ruling of the Munich local division regarding infringement. The Court of Appeal in Luxembourg heard the appeal at the beginning of September. The parties expect a decision soon.

In parallel proceedings, Meril had filed a second revocation action against Edwards EP 181 at the Paris central division, which the court has now decided at first instance. It is the first decision in the case regarding the Octapro device.

At the same time, the parties also disputed EP 3 669 828 at the Munich local division. In April this year, the court upheld the patent and found Meril had infringed. The court issued a sales ban on Meril’s Myval and the delivery system Navigator. Meril did not appeal the decision.

Edwards also claimed Meril’s Val-de-Crimp (Neo) crimping devices infringed its EP 3 763 331 and requested a PI from the Munich court. However the companies agreed to end these proceedings before it could rule.

All European representation

With the UPC dispute spanning divisions in several countries, the parties rely on international teams from different law firms. The teams had often already represented the clients in previous national proceedings concerning other heart-valve patents.

In the revocation action at the Paris central division, an IP team from the Paris-based firm Gide Loyrette Nouel represented the plaintiff Meril. Partners Emmanuel Larere and Jean-Hyacinthe de Mitry, led the case. UK patent attorneys Jonathan Stafford and Gregory Carty-Hornsby from Marks & Clerk provided technical advice in Paris as well as in the Munich proceedings. They have previously advised Meril in EPO proceedings.

A large team from Hogan Lovells represented Meril in the Munich proceedings. 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. Due to the importance of the proceedings, however, Meril decided to spread the roles across more shoulders and brought a team from Wildanger Kehrwald on board. At the Nordic-Baltic regional division, Karin Westerberg and Julia Ericsson from Swedish firm Sandart acted as local advisors.

Powell Gilbert for Edwards

In Paris Edwards relied on a UK team from Powell Gilbert led by lawyers Siddharth Kusumakar, Tess Waldron, Bryce Matthewson and Adam Rimmer. Bernhard Thum and Jonas Weickert from German patent attorney firm Thum IP provided technical advice.

Meanwhile a Munich-based team from Bird & Bird around lead partner Boris Kreye represented the US client together with Thum IP in the Munich proceedings. In the parallel case at the Nordic-Baltic regional division, Powell Gilbert cooperates with litigator Jens Olsson from Gulliksson.