European update

22 Sep 2021

There have been several recent developments in the ongoing patent litigation concerning Edwards Lifesciences and Meril, and this summary will serve as an update about recent decisions in Europe that may be helpful for you as you care for your patients.

Please note that the decision to pursue this litigation was not taken lightly. Edwards’ goal is to improve and save patients’ lives through the advances of true innovation to address unmet patient needs. This commitment to innovation requires decades of investments and risk-taking to solve some of the deadliest diseases and lengthen and improve the quality of patient life through advanced, sophisticated medical technologies.
 
Imitators make little attempt to build new, innovative technologies or contribute to science. Instead, they simply attempt to copy a trusted and proven medical technology, undermining the incentive for innovative companies to invest resources and take the necessary risks to bring innovative, life-changing therapies to physicians and patients. In the long-term, these tactics are harmful to patients and all of society.

We are proud that over the last 20 years, we have collaborated with clinicians on the development of multiple versions of the SAPIEN platform, new delivery systems and sheath technology, and the continuous refinement of the TAVI procedure with the SAPIEN valves, serving patients all around the world.

Poland: Polish courts have granted preliminary injunctions against two Meril distributors, Symico and Neomed. These injunctions stop sales, offers for sale, imports, exports, and commercial activity for Myval by both distributors in Poland. The court decisions are subject to appeal. Additional lawsuits asserting Edwards’ patents against Meril and its distributors are pending in Poland. The results of these will be reported when available.

Germany: Meril has stopped defending all lawsuits asserting Edwards’ patents in Germany. Due to the injunction and Meril’s agreement not to sell Myval in Germany, Meril cannot conduct commercial activity with the current Myval system in Germany for the duration of the patents, the last of which expires in 2031.

• In March 2021, the court did not grant Meril’s request for a compulsory license on its half and XL sizes. None of Meril’s Myval valves will be available for sale, regardless of size. In previous rulings:
• Feb 2021, Meril agreed to stop selling the current model of its Navigator delivery system in Germany. [EP3494929]
• September 2020, the court found Meril’s Myval infringes Edwards’ patent and granted a preliminary injunction.  [EP3494928B1]

UK: In March 2021, the UK High Court issued a final injunction against Meril preventing it from importing, exporting, selling, offering for sale or promoting the Myval THV in the UK. Meril will not be able to launch any infringing products in the UK for the duration of the patents, the last of which expires in 2031.

Italy: On June 16th, the Court of Turin, Italy issued a preliminary injunction against Meril and its Italian distributor, Viglia. This injunction prohibits the sale, offer for sale, use and promotion of Myval devices in Italy by Meril and Viglia effective immediately. Additionally, the court ordered the seizure of Myval devices within Italy and publication of the decision on Meril Life Science Ltd., Meril Gmbh and Viglia s.r.l. websites for 60 days. See www.myval.com Meril is not appealing the PI order.

• A court in Milan, Italy declined to enter an injunction against Meril concerning Edwards’ patent EP1267753 on procedural grounds.
• A third preliminary injunction is pending in Naples, Italy against a different Meril distributor.  [EP3593762, EP3590471, EP3494928]

Denmark

• Vingmed/Vicare Group: A Danish Court entered a preliminary injunction prohibiting the import and sale of the Meril Myval transcatheter aortic valve replacement system because Edwards settled its patent infringement lawsuits against the Vingmed/Vicare Group for an undisclosed amount. As a result, the Vingmed/Vicare Group will no longer be permitted to sell, import, export, offer for sale or promote Meril’s Myval THV in Norway, Sweden, Denmark, Finland and other countries. Additional details of the settlement are confidential. This matter is not subject to appeal.
• Neomed: On Aug 30, 2021, the Maritime and Commercial High Court in Copenhagen, Denmark, issued a preliminary injunction against Meril’s distributor Barbara Stańczyk Neomed, finding it probable that Meril’s Myval THV  infringes Edwards’ European patents EP 3 593 762 and EP 3 498 226.   The preliminary injunction became effective on Sept 10, 2021, and as of this date Neomed is prohibited from offering and selling Myval THVs and Navigator THV delivery systems in Denmark. Further, Neomed are required to recall products currently in the market.

Sweden: On Sept 17, 2021, the court in Sweden issued a preliminary injunction against Meril finding it probable that Meril’s Myval THV infringes Edwards’ European patent EP 3 494 930 effective immediately. In addition, they issued an injunction against the distributor EPS Vascular AB effective Oct 15th.  The court’s order will prohibit Meril and EPS Vascular AB from importing and selling Myval systems in Sweden.

Additional suits asserting Edwards’ patents are pending in Denmark, Sweden, Spain, France, Netherlands, Austria and Hungary against Meril and/or its distributors.