Edwards Wins United States Injunction on Sales of Medtronic's CoreValve TAVR System

April 11, 2014—Edwards Lifesciences (Irvine, CA) announced that the United States District Court for the District of Delaware granted a preliminary injunction limiting the sale of the CoreValve transcatheter aortic valve replacement (TAVR) system (Medtronic, Inc., Minneapolis, MN) in the United States. The injunction is effective in 7 business days from the time of the issuance.

Also on April 11, Medtronic announced that it is appealing the district court's injunction, and that it intends to ask the United States Court of Appeals for the Federal Circuit to prevent it from going into effect until that court determines if the injunction was properly issued. Medtronic noted that at its request, the district court agreed to postpone the implementation of the order for 7 business days to allow Medtronic to seek prompt relief from the Court of Appeals. 

Medtronic advised that the preliminary injunction ruling has 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.

In January 2014, the CoreValve system received US Food and Drug Administration approval for patients at extreme risk for surgical valve replacement. The CoreValve system is not approved in the United States for other patient groups.

At the conclusion of the hearing, Chief Judge Gregory Sleet ordered Edwards and Medtronic to confer on in what instances the CoreValve device could continue to be used in the treatment of patients in the United States at centers currently trained on CoreValve.

Edwards stated that it is committed to ensuring patients have appropriate access to TAVR therapy and noted that there is a large body of evidence demonstrating the safety and performance of the Edwards Sapien TAVR systems.

Medtronic noted that the two companies’ immediate discussions will allow them to agree on a mechanism to enable physicians at facilities currently trained on CoreValve to make a clinical judgment, free from the limitations of the injunction, as to which company’s device to implant.

According to Edwards Lifesciences, the injunction was issued at a hearing related to a federal jury decision in 2010 that CoreValve willfully infringes Edwards’ Andersen TAVR United States patent, part of the company’s Andersen family of patents. The Andersen patent was issued in 1995, and Edwards has filed a petition with the US Patent and Trademark Office to extend this patent into early 2016.

Edwards initiated this case in 2008, and on April 1, 2010, a federal jury found that Medtronic willfully infringed the Andersen patent and awarded damages. In November 2012, the United States Court of Appeals for the Federal Circuit affirmed the jury decision; in October 2013, the United States Supreme Court declined to hear Medtronic’s appeal.

Edwards also stated that in January 2014, a federal jury in a separate case found that the Medtronic CoreValve willfully infringed Edwards’ Cribier transcatheter heart valve United States patent and awarded damages to Edwards in that trial.