Medtronic Inc. lost the latest round in a long-running legal dispute and got stung with a $74 million judgment when a U.S. District Court jury in Delaware found that its CoreValve heart valve system infringes on patents held by Edwards Lifecsciences Inc.
The case if far from over, however, as Medtronic said it will appeal the jury's verdict. Edwards plans to seek an injunction that would block Medtronic from selling the CoreValve system in the U.S.
The dispute centers around the CoreValve transcatheter system, which allows a replacement heart valve to be placed in a patient's body using a catheter inserted in a large artery in the thigh. Edwards has maintained that CoreValve's technology infringes on its "Andersen family" of patents, which covers heart valve replacements performed via catheters.
The legal battle stretches back to 2007, when California-based Edwards and CoreValve sued each other over the technology. The dispute became Medtronic's problem last year when it acquired CoreValve for $700 million.
While saying it plans to appeal, Medtronic downplayed the significance of the verdict. The Fridley-based device giant said the verdict had "no bearing" on its ability to sell the CoreValve internationally or conduct clinical trials in the U.S.
Medtronic also said the patents in question are likely to expire before the CoreValve system receives clearance for U.S. sales by the Food and Drug Administration. The patents are scheduled to expire in 2018, Medtronic said.
Previous rounds in the dispute have ended more favorably for Medtronic. In February, a German court ruled that the CoreValve system didn't infringe on Edwards' patents. Last month, a federal judge in Delaware ruled that one of the three patents that Edwards sought to uphold couldn't be included in the case.
Last month, Medtronic began a large international clinical trial of CoreValve. The study is significant for Medtronic because the company has made a big bet that transcatheter systems will grow more widespread as a less-invasive means of implanting replacement heart valves. Medtronic estimates that the market size for the transcatheter valve-replacement procedures could grow as large as $3.5 billion annually.
The CoreValve system received regulatory clearance for sales in Europe in 2007.
--Brandon Glenn, MedCity News