Medtronic To Pay Edwards Over $1B To Settle TAVR Patent Dispute

By Jof Enriquez,
Follow me on Twitter @jofenriq

Medtronic and Edwards Lifesciences have finally settled an ongoing patent dispute involving the companies’ devices for transcatheter aortic valve replacement (TAVR), also known as transcatheter aortic valve implantation (TAVI). The settlement will allow for both companies to sell their respective devices worldwide.

In order to settle the worldwide litigation, Medtronic will pay Edwards Lifesciences an upfront payment of $750 million, plus royalties of not less than $40 million annually through April 2022 as a percentage of Medtronic’s CoreValve device sales, according to a recent Medtronic press release.

Moreover, the two companies agreed to dismiss all pending patent cases and appeals and to refrain from suing each other over competing aortic and other transcatheter heart valves over the next eight years.

When Edwards won a legal dispute in April against Medtronic that led to an injunction of CoreValve sales in the U.S., doctors and patients became worried that the dispute between the two rivals would be detrimental to clinical outcomes.

“The injunction ... sent some doctors scrambling to obtain the Medtronic devices and implant them in sick patients before the injunction went into effect,” according to a report by the Wall Street Journal. “Doctors said they needed both devices on the market because the Medtronic device is a better fit and safer for some patients.”

The decision was later stayed after Medtronic appealed the ruling, but it brought to light the severe — at times life-threatening — implications of the legal dispute.

“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,” John Liddicoat M.D., president of the structural heart business at Medtronic, said in the statement. “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.”

In an Edwards Lifesciences statement about the global settlement, Michael A. Mussallem, Edwards Lifesciences’ chairman and CEO said, “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.”

Medtronic and Edwards Lifesciences are the two largest manufacturers of TAVR products used for less-invasive treatment of diseased aortic valves. The U.S. market for these devices is valued at $500 million this year and expected to double in size by 2018, according to a New York Times article, quoting Jefferies analysts.