May 20, 2014
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Edwards, Medtronic settle transcatheter valve litigation

Edwards Lifesciences and Medtronic today announced the settlement of all outstanding patent litigation between the companies, including cases related to transcatheter heart valves.

Perspective from Michael J. Reardon , MD

Under the terms of the settlement, Medtronic will make a one-time payment to Edwards of $750 million, and will make ongoing royalty payments through April 2022 based on a percentage of sales of its CoreValve transcatheter valve, not to exceed $40 million per year.

Both companies agreed to dismiss all pending lawsuits against each other, and to not sue each other for patent matters anywhere in the world for 8 years in the field of transcatheter heart valves, according to press releases from both firms.

In April, Edwards, which makes the Sapien balloon-expandable transcatheter valves, had received a partial injunction to block Medtronic from selling the CoreValve self-expandable transcatheter valve in the United States, but its implementation was postponed pending an appeal.

“We are pleased to reach an agreement that preserves physician choice while also recognizing Edwards’ leadership in pioneering transcatheter heart valves that are chosen most often by physicians worldwide,” Michael A. Mussallem, chairman and CEO of Edwards, said in the firm’s press release. “This agreement allows us to move forward, fully dedicating our time and resources to helping patients.”

“This agreement brings an end to years of disputes between our companies related to [transcatheter aortic valve replacement] patents, and allows both companies to make their respective therapies available to physicians and patients around the world,” John Liddicoat, MD, president of Medtronic’s structural heart business, said in that firm’s release. “With this resolution, we are pleased that Medtronic will be able to continue to provide the CoreValve System, as well as other products, to patients who need them in the United States and abroad without the overhang of any potential injunction or additional damages.”

In its press release, Edwards stated that it will contribute $50 million from the settlement to the Edwards Lifesciences Foundation to support efforts to improve patient care, raise disease awareness and educate clinicians.