Feature | May 20, 2014| Dave Fornell

Edwards, Medtronic Agree to Global Transcatheter Valve Litigation Settlement

All TAVR patent litigation between the companies to be dismissed

Corevalve, FDA, Edwards, TAVR, TAVI, lawsuit, injunction

May 20, 2014 — In a surprise move, Edwards Lifesciences Corp. and Medtronic reached an agreement this week to settle all outstanding patent litigation between the companies, including cases related to transcatheter heart valves. The agreement will result in the dismissal of all pending cases or appeals in courts and patent offices worldwide, and includes a provision that the parties will not litigate patent disputes with each other in the field of transcatheter valves for the eight-year duration of the agreement.

The companies have been embroiled in patent litigation over their transcatheter aortic valve replacement (TAVR) systems in Europe and the United States for the past several years. There has been concern by many top physicians that the competition would hinder patient access to these life-saving therapies. This concern was heightened with recent clinical trial data showing Medtronic’s CoreValve out-performed surgical valve replacement in some patients. However, this was tempered when Edwards filed an injunction against the sale of the valve in the U.S. market. 

Under the agreement, Medtronic will pay Edwards a one-time payment of $750 million, and ongoing royalty payments through April 2022 based on a percentage of CoreValve sales, in payments of no less than $40 million annually. 

In addition to settling the pending lawsuits with cross-licenses, Medtronic and Edwards have agreed that neither party will sue the other for patent matters anywhere in the world for eight years in the field of aortic and all other transcatheter heart valves.

"This agreement brings to an end years of disputes between our companies related to TAVI [transcatheter aortic valve implantation] 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."

Edwards 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, such as through its Every Heartbeat Matters philanthropic program.

"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.

For more information: www.edwards.com, www.medtronic.com

Related Content

Cardiac CT scan showing plaque and calcification in the coronary arteries, from a Toshiba CT scanner
News | Business| July 19, 2017
July 19, 2017 — The Society of Cardiovascular Computed Tomography (SCCT) created a reimbursement fee chart for cardia
Sponsored Content | Videos | Cardiac Imaging| July 18, 2017
Leslee Shaw, Ph.D., director of clinical research and professor of medicine at Emory University, Atlanta, and past-pr
Senate Healthcare Bill Denied Passage
News | Business| July 18, 2017 | Jeff Zagoudis, Associate Editor
July 18, 2017 — Last-minute defections from two Republican senators early Tuesday ensured the chamber’s version of th
SCAI comments on CMS payment schedule
Feature | Business| July 17, 2017
July 17, 2017 — The Centers for Medicare and Medicaid Services (CMS) released the 2017 Medicare Trustees Report, the
First Patient Treated in U.S. Feasibility Study of LimFlow Critical Limb Ischemia Device
News | Peripheral Arterial Disease (PAD)| July 17, 2017
LimFlow SA announced enrollment of the first patient in the U.S. feasibility study of the LimFlow Percutaneous Deep...
Alere point of care POC testing for INR
News | Point of Care Testing| July 17, 2017 | Dave Fornell
July 17, 2017 — Despite issues with point-of-care INR testing company Alere Inc., Abbott announced this week it is on
FDA Approves Six-Month Primary Endpoint for Tack Endovascular System in Below the Knee Disease
News | Stents Peripheral| July 14, 2017
Intact Vascular Inc. announced the U.S. Food and Drug Administration (FDA) approved an Investigational Device Exemption...
Edwards Sapien 3 TAVR valve will be implanted in asymptomatic aortic stenosis patients in the EARLY TAVR Trial
Feature | Heart Valve Technology| July 14, 2017
July 14, 2017 — Morristown Medical Center, part of Atlantic Health System, has randomized the first patient in the wo
CMS Proposes Delaying Clinical Decision Support Documentation to 2019
News | Clinical Decision Support| July 14, 2017 | Jeff Zagoudis, Associate Editor
In a series of proposed rule changes to the Medicare Physician Fee Schedule (MPFS) released July 13, the Centers for...
Senate Releases Revised Version of Better Care Reconciliation Act
News | Business| July 13, 2017
As the debate over healthcare insurance coverage continues, Senate Republicans on Thursday unveiled the revised version...
Overlay Init