TAVR détente: Edwards, Medtronic settle patent dispute

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Edwards Lifesciences and Medtronic reached a cross-license settlement over transcatheter aortic valve replacement (TAVR) devices with provisions that should put their patent dispute to rest.

The two companies announced that they will dismiss all pending cases or appeals over TAVR valves for eight years. As part of the settlement, Minneapolis-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.

The two companies engaged in a patent war over Edwards’ Sapien TAVR devices and CoreValve. Earlier this year a judge imposed a temporary injunction limiting the sale of CoreValve in the U.S. but then delayed its implementation.  

The valves are the only two products approved by the FDA as a treatment for inoperable patients with severe aortic stenosis. Edwards, which was first to receive FDA approval for its product, claimed that Medtronic infringed on a family of heart valve patents.

Sapien is the only TAVR device currently approved in the U.S. as a treatment for high-risk patients as well, although CoreValve is being evaluated for that indication. Results from the U.S. CoreValve High Risk randomized controlled clinical trial, presented at ACC.14 in Washington, D.C., in March, showed CoreValve to be superior to surgical aortic valve replacement in high-risk patients at one year.

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.