The two companies announced they will dismiss all pending cases or appeals over TAVR valves for eight years. As part of the settlement, Minneapolis, Minn.-based Medtronic will pay a one-time fee of $750 million to Edwards. Medtronic also will make royalty payments to Edwards of up to $40 million annually for sales of its CoreValve device.
This agreement brings to an end years of disputes between our companies related to TAVI patents, and allows both companies to make their respective therapies available to physicians and patients around the world," said John Liddicoat M.D., president of the Structural Heart business at Medtronic. "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 U.S. and abroad without the overhang of any potential injunction or additional damages. "
The two companies have been engaged in a bitter patent war over Edwards’ Sapien TAVR devices and CoreValve. The dispute --- one of several between the two companies --- involves Edwards’ Andersen family of heart valve patents; the Andersen patent was granted in 1995. Edwards charged in 2008 that Medtronic infringed on the patent, and in 2010 a federal jury ruled in favor of Edwards, which was upheld on appeal. Edwards has requested a patent extension into early 2016.
Earlier this year, a judge imposed a temporary injunction limiting the sale of CoreValve in the United States but then delayed its implementation.
The valves are the only two products approved by the U.S. Food and Drug Administration (FDA) as a treatment for inoperable patients with severe aortic stenosis. Edwards, which was first to receive FDA approval for its product, claimed Medtronic infringed on a family of heart valve patents.
"We are pleased to reach an agreement that preserves physician choice while also recognizing Edwards' leadership in pioneering the transcatheter heart valves that are chosen most often by physicians worldwide. This agreement allows us to move forward, fully dedicating our time and resources to helping patients," said Michael A. Mussallem, Edwards' chairman and CEO.
Medtronic announced that neither company admitted that their products infringed any patents or that any patents were invalid. Edwards, based in Irvine, Calif., said that it will contribute $50 million from the settlement to the Edwards Lifesciences Foundation.
The CoreValve System received approval from the FDA in January 2014. Based on the strength of the clinical data, the FDA quickly reviewed and approved the CoreValve System for patients at extreme risk for surgical valve replacement in January. The CoreValve System is not yet approved in the United States for other patient groups.
Data presented at the American College of Cardiology (ACC) annual meeting in March 2014 and simultaneously published in The New England Journal of Medicine showed that patient results with CoreValve System were superior to surgical aortic valve replacement (SAVR) at one year in patients at increased risk for surgery. This is the first time a prospective, randomized study has shown any transcatheter aortic valve to be superior to surgery.
Upon reviewing the CoreValve Trial's results for high-risk patients, the FDA determined it has sufficient information to evaluate the safety and efficacy of the Medtronic CoreValve System for this patient group without the need for an external expert panel. As such Medtronic anticipates FDA approval of the CoreValve System for high-risk patients sometime this summer.