A German appeals court lifted an injunction preventing the sale of Medtronic's ($MDT) transcatheter aortic heart valve in the country, a major defeat for archrival Edwards Lifesciences ($EW) and the latest development in a nasty patent fight that long ago went international.
The court's ruling allows Medtronic to resume marketing of its CoreValve System in Germany, which had been banned from sale since late August 2013. According to the Minnesota device giant, the ruling is based on a preliminary opinion issued by the European Patent Office a few weeks ago determining that Edwards' claims regarding its Spenser patent weren't valid. Medtronic must post a $6.7 million bond, after which CoreValve marketing in Germany can resume.
"Medtronic is very pleased with this decision as it will ensure that patients in Germany who need aortic valve replacement will have access to this life-saving therapy," Dr. John Liddicoat, senior vice president of Medtronic's structural heart division, said in a statement.
Edwards has argued that CoreValve infringes on patents connected to Sapien, its own transcatheter aortic valve replacement and a global success story for the company. Medtronic bought CoreValve for $700 million in 2008, and Edwards sued in the U.S. shortly after. CoreValve doesn't yet have FDA approval, but it has been CE marked in Europe, so Edwards has also been battling the company overseas.
Edwards issued a statement after the German court ruling, framing the circumstances a bit differently than Medtronic. Medtronic had said that the European Patent Office determined Edwards' claims were invalid. But Edwards recounted that the EPO decision indicated "concerns about the validity of the Edwards Spenser patent." An Edwards spokesperson noted to FierceMedicalDevices via email that "we have discussed previously that we disagree with the EPO's preliminary opinion and will challenge it."
To be sure, California-based Edwards has scored plenty of victories of its own. In October, the U.S. Supreme Court rejected Medtronic's attempt to overturn an earlier court loss in the Sapien-CoreValve patent dispute. As a result, Edwards can keep its $83.6 million award, as well as a significant U.S. market share. Edwards is also working to extend its Sapien patent through 2017, and it has a right in the U.S. to seek an injunction on future CoreValve sales.
This fight isn't over yet, not by a long shot.
- here's Medtronic's release
- check out Edwards' statement