Edwards Lifesciences Inc. (NYSE:EW) won a major round in its patent war with Medtronic Inc. (NYSE:MDT) subsidiary CoreValve when a Delaware federal jury ruled that CoreValve willfully infringes an Edwards patent.
The jury in the U.S. District Court for Delaware awarded $73.5 million in damages and opened the door for Edwards to seek triple that amount, due to the finding of willfulness. It’s the latest development in a dispute over three patents covering “collapsible and expandable tissue valve prostheses and methods for replacing human heart valves using minimally invasive catheterization procedures,” the so-called Andersen patent family.
Edwards lost a few skirmishes along the way, with a German court deciding that CoreValve’s transcatheter aortic valve does not infringe on Edwards’s patent in that country and Judge Gregory Sleet judge throwing out Edwards’ claims for one of the patents in the Delaware suit.
That case is far from over. Edwards said it plans to seek a permanent injunction barring the manufacture and sale of the CoreValve device in the U.S. Medtronic said it plans to appeal the verdict, asserted that it will still sell the device overseas and run it through clinical trials and claimed that the patent will likely expire before Edwards wins clearance from the Food & Drug Administration for its device. A spokeswoman for Edwards wrote in an email that the company is expecting to obtain FDA approval for its device next year.
The CoreValve system is designed to enable the replacement of a diseased aortic valve without open heart surgery. Edwards and CoreValve Inc. began the patent spat when the Irvine, Calif.-based rivals filed suit against each other in 2007. Medtronic inherited the beef when it purchased CoreValve in April 2009 for about $700 million.
It’s not the only legal imbroglio for CoreValve, however. In March the U.S. Attorney for Massachusetts demanded documents in a false claims probe into the relationship of its CoreValve subsidiary with the Burlington, Mass.-based Lahey Clinic, “specifically relating to cardiologists at the clinic, CoreValve Inc. … and the Lahey Clinic, and certain employees of both [Medtronic] and the clinic, among other topics.”
Also earlier in March, Medtronic launched what’s expected to be a 1,000-patient study of the CoreValve system, hoping to win clearance for the device from the Food & Drug Administration. The CoreValve system was approved for sale in Europe in 2007.