Edwards Initiates Injunction Against Sales of Medtronic's CoreValve TAVR Devices in Germany

August 26, 2013—Edwards Lifesciences (Irvine, CA) announced that the injunction against sales in Germany of the CoreValve and CoreValve Evolut transcatheter heart valve systems (Medtronic, Inc., Minneapolis, MN) has gone into effect. The District Court of Mannheim, Germany ruled on July 12 that Medtronic is infringing Edwards's Spenser patent—EP 2 055 266 B1—for transcatheter heart valve technology. The court issued an injunction prohibiting the sale of Medtronic's CoreValve and CoreValve Evolut systems in Germany and ordered a recall of these products. Edwards has provided the bond that is required to initiate the injunction. Medtronic is appealing this ruling, advised Edwards.

According to Edwards, the company filed this case in August 2012 and it relates to three patents, including the Spenser patent, which is in effect until October 2022. The Spenser patent is in place in other European countries, including France, Italy, Spain, and others. Medtronic is contesting the validity of the Spenser patent at the European Patent Office.

On July 12, Medtronic stated that it respectfully disagrees with the court's decision and intended to appeal the ruling. Medtronic asserted that the court's decision will limit options for physicians and their patients who need transcatheter aortic valve procedures, which the company believes is contrary to sound health policy.

Medtronic stated that in the separate European Patent Office proceeding in which the company and others have challenged the validity of the Spenser patent, the company believes that Edwards's patent claims will be found to be invalid, which will negate the German court's ruling of patent infringement.

Medtronic noted that the injunction affects commercial sales of the CoreValve system only in Germany. These actions have no impact in any market on the Medtronic Engager transcatheter valve, the Melody pulmonic transcatheter valve, or any other Medtronic product. Medtronic does not anticipate any interruption to the global supply of the CoreValve system outside of Germany.

While asserting the importance of protecting its intellectual property to ensure continued innovation, Edwards advised that it is providing for exceptions to the injunction to ensure German physicians continue to have access to therapy in instances where the Edwards Sapien XT valve is not indicated, subject to Medtronic's cooperation. Edwards stated that the company will not seek compensation for the valves in these compassionate use cases in Germany. There are estimated to be about 40 such cases per month, noted the company.

Edwards stated that more than 80% of the transcatheter valve centers in Germany utilize the Edwards Sapien XT valve, and that it has reached out to all of the German centers that do not currently have experience with the Sapient XT valve to offer training and proctoring.