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Edwards Lifesciences European update

Nov. 26, 2020

There have been a number of 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 know 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 most deadly diseases.
Imitators make little attempt to build new, innovative technologies or contribute to science. Instead, they simply attempt to imitate a trusted and proven medical technology. In the long-term, these tactics stifle innovation and are harmful to patients.

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.

Nordics: A Danish Court recently entered a preliminary injunction prohibiting the import and sale of the Meril Myval System by the Vingmed/Vicare Group, a distributor for the Meril Life Sciences’ Myval transcatheter aortic valve replacement system. In addition, 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 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.

UK: A court in the UK ruled in favor of Edwards concerning Edwards patent EP 3 494 929, which covers the delivery system approved for use with the Myval. The court issued an injunction that prohibits Meril launching the infringing Myval system in the UK. Further legal proceedings are expected.

Germany: A court in Germany ruled in favor of Edwards concerning Edwards patent EP 3 494 928, and issued a preliminary injunction that prohibits MyVal commercial activity in Germany. Further legal proceedings are expected.

Italy: A court in Milan, Italy, declined to enter an injunction against Meril concerning Edwards patent EP 1267753, on procedural grounds. A second preliminary injunction request concerning Edwards patents EP 3 494 929, EP 3 494 930, EP 2 628 464 and EP 3 498 226 is pending in Turin, Italy, with a decision expected mid-2021.

Thank you for your understanding of this matter, and please reach out to our team if you have any questions or would like additional information.

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