A federal appeals court today put a hold on the impending ban on U.S. sales of Medtronic‘s (NYSE:MDT) CoreValve replacement heart valve "pending further notice," as Medtronic’s patent infringement war with rival Edwards Lifesciences (NYSE:EW) and its competing Sapien valve grinds on.
Earlier this month Judge Gregory Sleet of the U.S. District Court for Delaware granted a preliminary injunction to Edwards, limiting U.S. sales of the CoreValve transcatheter aortic heart implant to patients deemed unsuitable for Edwards’ rival Sapien device.
Medtronic promptly appealed the ban, slated to begin April 23, to the U.S. Court of Appeals for the Federal Circuit, drawing a rebuke from Sleet.
But the appeals court today granted Medtronic’s bid to stay the injunction indefinitely, with 2 of the Federal Circuit’s 3 judges agreeing to hold the sales ban on CoreValve, according to court documents.
"The district court’s injunction is stayed pending further notice by this court," according to the documents.
But Federal Circuit Judge Pauline Newman dissented, citing a deal between Medtronic and Edwards that would have allowed limited CoreValve sales to patients deemed unsuitable to receive the Sapien device.
"I would deny the motion to stay subject to the terms of the recent agreement between Edwards and Medtronic that Medtronic may provide its devices pending this appeal," Newman wrote.
"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," Medtronic structural heart president Dr. John Liddicoat said in a statement.
"We have always made every effort to ensure patients receive the treatment they need and will continue to seek a durable solution that benefits physicians and their patients. We’re proud of the track record and large amount of clinical data supporting the performance of the Sapien family of valves, making them the preferred choice for doctors treating their patients around the world," Edwards chairman & CEO Mike Mussallem said in prepared remarks.
Edwards initially filed the infringement claim in 2008 against CoreValve, then an independent entity (Medtronic acquired CoreValve in 2009). A federal jury ruled in 2010 that the CoreValve device willfully infringes Edwards’ "Andersen" patent, also known as the ‘552 patent. The U.S. Court of Appeals affirmed that decision in 2012 and the Supreme Court last year refused to hear Medtronic’s appeal. Earlier this year the FDA approved the CoreValve system for sale in the U.S.
The legal battle is also happening overseas, where the European Patent Office in October 2013 issued a preliminary, non-binding ruling that an Edwards’ patent was invalid, allowing CoreValve back on the German market after a temporary ban. The EPO last month finalized that ruling, entirely invalidating and revoking the so-called "Spenser patent" at the heart of the overseas dispute.
Edwards earlier this year won a $393 million decision after a Delaware jury ruled that CoreValve infringes on Edwards’ "Cribier" patent.
