Medtronic announced that the European Patent Office has invalidated, in its entirety, the Edwards Lifesciences EP2055266 Spenser patent which was the basis for the August 26, 2013 injunction prohibiting sales of the CoreValve System in Germany.
In its ruling, the European Patent Office in The Hague said the entire patent is invalid and therefore revoked.
“Medtronic is very pleased with this ruling as it will ensure that patients across Europe who need aortic valve replacement will have access to this life-saving therapy,” says John Liddicoat, senior vice president, Medtronic, and president of the Medtronic Structural Heart Business.
In October, the European Patent Office issued a preliminary opinion that questioned the validity of this patent, and this led the Higher Regional Court Karlsruhe to order the discontinuation of the prior court ruling that prohibited Medtronic from commercially marketing or selling the CoreValve System in Germany. The most recent ruling is subject to further appeal.
The CoreValve System was designed specifically to overcome the challenges of a broad range of TAVI patients. The device has a small 18-Fr profile for all four valve sizes, which minimises trauma at implant, and allows physicians to treat patients with small or calcified vasculature. Its Nitinol frame is designed to prevent unwanted leakage and optimise blood flow. In addition, the CoreValve System is available in the broadest range of sizes available, so patients who have smaller, larger or in-between sizes can be accommodated.
The CoreValve System received CE Mark in 2007, and received U.S. Food and Drug Administration (FDA) approval for patients at extreme risk for surgery in January 2014.