Edwards Lifesciences (NYSE:EW) notched a major win against rival Medtronic (NYSE:MDT) today when a court ordered a preliminary injunction limiting Medtronic from selling its CoreValve transcatheter aortic valve implantation system in the U.S.
It’s a harsh blow for Medtronic, which just earlier this year won FDA approval for CoreValve. The injunction takes effect in 7 days.
The decision was years in the making, stemming back to a 2010 federal jury ruling that Medtronic willfully infringed on Edwards’ patents for its Sapien TAVI system. The U.S. Court of Appeals affirmed that decision in 2012 and the Supreme Court last year refused Medtronic’s request for a hearing.
The U.S. battle came to a head earlier this year when the FDA approved the CoreValve system for sale in the U.S. Edwards chairman & CEO Michael Mussallem said shortly before the FDA decision that the company intends to fight for its territory in the U.S.
"Our intention is to very aggressively respond to that competition," Mussallem said during January’s J.P. Morgan Healthcare conference in San Francisco. "It’s a critical time to be meeting force with force."
The companies were ordered today to spend some time conferring on medical cases in which Medtronic may still sell the CoreValve transcatheter aortic valve implantation system in the U.S.
"There is a large body of evidence demonstrating the safety and performance of the Edwards SAPIEN valves, and the company remains committed to ensuring patients have appropriate access to transcatheter therapy," Edwards said in prepared remarks.
The companies have been at war over TAVI technology for years, and Medtronic appears to be in the lead overseas. The European Patent Office in October 2013 issued a preliminary, non-binding ruling that Edwards’ patent was invalid. Medtronic lauded the decision, which allowed 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. The ruling gave Medtronic some new leverage for the battle ahead, but Edwards has other patents up its sleeve.
Today’s decision from the U.S. District Court for the District of Delaware was tied to Edwards’ so-called "Andersen" patents. Edwards earlier this year won a $393 million decision after a Delaware jury ruled that CoreValve infringes on Edwards’ "Cribier" patent.
Medtronic did not immediately respond to requests for comment.