Edwards Lifesciences Inc. says it will appeal a Delaware judge’s decision not to bar the manufacture and sale of Medtronic Inc.’s CoreValve aortic valve replacement.
Medtronic Inc. (NYSE:MDT) managed to find the silver lining in the dark cloud that is a $74 million patent infringement judgment against it when a federal judge denied an Edwards Lifesciences Inc. (NYSE:EW) move to bar U.S. manufacturing and sales of its CoreValve aortic valve replacement.
The Fridley, Minn.-based medical device maker said Judge Gregory Sleet of the U.S. District Court for Delaware shot down a motion filed by Edwards seeking an injunction against making and selling the CoreValve device Medtronic acquired in its $700 million buyout of CoreValve Inc. in 2009.
In April 2010 a jury found that CoreValve willfully infringes an Edwards patent, awarding $73.5 million in damages and opening the door for Edwards to seek triple that amount due to a finding of willfulness. Sleet’s latest ruling also closed that door for Edwards.
The dispute involves 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’ patent in that country and Sleet judge throwing out Edwards’ claims for one of the patents in the Delaware suit.
Medtronic said it plans to appeal the verdict. The company has claimed that Edwards’ rights to the intellectual property are likely to expire before that company can win clearance from the Food & Drug Administration for its device. (A spokeswoman for Edwards wrote in an email in April 2010 that the company is expecting to obtain FDA approval for its device this year.)
Responding to the latest ruling, Edwards pointed out that it will now collect additional damages from Medtronic “due to continued infringing sales from the date of the trial through the life of the patent, plus interest,” adding that it plans to appeal the adverse rulings “promptly.”
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.
It’s not the only legal imbroglio for CoreValve, however. In March 2010 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.”
And earlier that month, 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. Medtronic is also running a pivotal trial of the device in the U.S.
The Massachusetts Medical Devices Journal is the online journal of the medical devices industry in the Commonwealth and New England, providing day-to-day coverage of the devices that save lives, the people behind them, and the burgeoning trends and developments within the industry.
