Medtech titan Medtronic (NYSE:MDT) landed a major win against arch-rival Edwards Lifesciences (NYSE:EW) when the European Patent Office revoked an Edwards patent at the heart of a contentious infringement lawsuit.
The EPO decision stymies Edwards’ efforts to keep Medtronic’s CoreValve transcatheter aortic valve implantation system off the market, but doesn’t affect Edwards’ own sales. The ruling is open for appeal and Edwards plans to pursue one, spokeswoman Sarah Huoh told MassDevice.com.
"While we are disappointed by the oral opinion announced today by the European Patent Office’s Opposition Division, we intend to appeal and will continue our main focus: Responsibly innovating transcatheter heart valve therapy for patients in need," Huoh said via email today. "The ruling has no impact on Edwards’ ability to offer the Edwards Sapien XT or Sapien 3 transcatheter heart valves. European patients will continue to have access to all necessary transcatheter therapy."
The EPO ruling marks a major turnaround for Medtronic, which took some heavy blows in the long-running war with Edwards. The companies have been at war since 2007, beginning with Edwards and CoreValve. Medtronic acquired CoreValve’s technology and its feud in 2009.
Edwards has tallied some big wins against Medtronic during the last year, including a July 2013 injunction against CoreValve sales in Germany after a court in Mannheim ruled that the CoreValve device infringes Edwards’ EP2055266 Spenser patent, named for lead inventor Benjamin Spenser.
The TAVI market is huge in Germany, where nearly half of all elderly patients (those over the age of 75) get the operation, according to 2012 reports from the European Society of Cardiology Congress.
In the U.S., Edwards in April 2013 won a $74 million court decision against Medtronic, which was upheld by the U.S. Court of Appeals for the Federal Circuit. Medtronic attempted to the push the case to the Supreme Court, but the justices in October refused to hear the lawsuit.
The tides started to turn late last year when the EPO issued a preliminary, non-binding ruling that the Edwards patent was invalid. Medtronic lauded the decision, which allowed CoreValve back on the German market.
The EPO today finalized that ruling, entirely invalidating and revoking the Spenser patent. The ruling gives Medtronic some new leverage for the battle ahead, but Edwards has other patents up its sleeve. Edwards earlier this year won a $393 million decision after a Delaware jury ruled that CoreValve infringes on Edwards’ Cribier patent. Medtronic said at the time that it would appeal that decision, which included a judgment for willful infringement that could triple the price tag.
Edwards and Medtronic have been fighting legal battles at home and abroad, but the fight for market share is made its way to the U.S. just a few weeks ago when the FDA approved the CoreValve system for sale in the U.S. Edwards chairman & CEO Michael Mussallem has said 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. "It’s a critical time to be meeting force with force."