US Appeals Court Postpones Injunction Against Sales of Medtronic's CoreValve

April 21, 2014—Medtronic, Inc. (Minneapolis, MN) announced that the United States Court of Appeals for the Federal Circuit has granted the company’s request to postpone the implementation of an injunction that would have prevented Medtronic from selling its CoreValve transcatheter aortic valve replacement (TAVR) system in the United States. Therefore, the injunction—which was originally ordered to take effect on April 23—will only take effect if the appellate court determines the injunction was properly issued.

Medtronic had previously advised that it would appeal the April 11 decision of the United States District Court for the District of Delaware, which issued the injunction against sales of the CoreValve in the United States because the court found that the device infringed on a TAVR patent held by Edwards Lifesciences Corporation (Irvine, CA).

Edwards Lifesciences stated that the appeals court’s two-to-one decision, which places on hold the implementation of the preliminary injunction “pending further notice,” does not reverse the federal jury’s finding of Medtronic’s willful infringement, for which all appeals have been exhausted, and does not affect the determination of additional damages.

Medtronic advised that the Court of Appeals agreed to an expedited appeal of the injunction ruling, with the last appeal brief to be submitted by June 19. Medtronic stated that it does not believe Edwards Lifesciences, which brought the motion for a preliminary injunction, has met the standards needed for an injunction, particularly with respect to the impact it will have on the public interest.

In January 2014, the US Food and Drug Administration approved the CoreValve system for patients at extreme risk for surgical valve replacement. The court rulings have no impact on the sale or marketing of CoreValve outside of the United States or the use of CoreValve in the current United States clinical trials, noted Medtronic.