Medtronic (Minneapolis) reported that the federal Circuit Court of Appeals granted a request from the company to postpone the implementation of an injunction that would have prevented the company from selling its CoreValve System in the U.S. This means the injunction will only take effect if the appellate court determines the injunction was properly issued.
In addition, last week 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 said it does not believe Edwards Lifesciences (Irvine, California), 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.
"We believe this ruling is good news for patients who need the CoreValve device, and our primary objective has been to work closely with physicians to ensure that their patients are able to get the therapy they need," said John Liddicoat, MD, senior vice president, Medtronic, and president of the Medtronic Structural Heart Business in a company statement.
Edwards initiated the patent case in February 2008. In 2010, a jury decided Medtronic willfully infringed Edwards' U.S. Anderson patent and in November 2012 the U.S. Court of Appeals for the Federal Circuit affirmed that jury decision. Last year, the U.S. Supreme Court declined to hear Medtronic's appeal.
The Anderson patent was issued in 1995 and a petition has been filed with the U.S. Patent and Trademark Office to extend the patent into early 2016, Edwards noted.
Medtronic's CoreValve received FDA approval in January for patients considered to be at extreme risk for surgical valve replacement.