Medtronic willfully infringed on an Edwards Lifesciences’ patent with its CoreValve transcatheter heart valve, and owes Edwards nearly $394 million in damages and patent royalties, a federal jury in Delaware found Wednesday.
Edwards is still awaiting a decision on its request to enjoin Medtronic's entrance into the U.S. market with the CoreValve System, which Edwards claims violates one of its patents.
"Edwards holds a number of important patents in transcatheter valve technology, and we intend to continue to defend this intellectual property when it is used by others without permission,” says Larry L. Wood, Edwards' corporate vice president of transcatheter heart valves.
Medtronic officials say they plan to appeal the Wednesday jury verdict.
"Medtronic has prevailed against Edwards in several legal actions related to a European counterpart to this patent and others, and believes the Federal Circuit Court of Appeals will find no merit to Edward's infringement claim. Today's jury verdict does not impose an injunction, and Medtronic will oppose any requests for an injunction by Edwards,” says Neil Ayotte, vice president and acting general counsel at Medtronic.
Medtronic CoreValve
The ruling is a big deal for Edwards. The company has had trouble meeting U.S. sales projections for its flagship product: the Sapien percutaneous heart valve, which is still the only transcatheter aortic valve replacement product on the domestic market.
Medtronic entering the U.S. market with the CoreValve could further erode sales for the Sapien.
Medtronic had success last year getting the CoreValve back on the German market on appeal.
At the same time, Edwards cited a federal jury finding in 2010 that Medtronic CoreValve LLC willfully infringed on Edwards’ U.S. Andersen transcatheter heart valve patent, and awarded damages to Edwards. The finding was upheld on appeal, with Medtronic making an initial payment of $84 million to Edwards last year.
Click here to see a PDF of the federal jury ruling from Wednesday.
January has not been a good month for Medtronic. The company announced last week that its Symplicity renal denervation system for treatment-resistant hypertension failed to meet its efficacy endpoint in its U.S. pivotal trial.
