|Edwards Lifesciences' Sapien XT--Courtesy of Edwards|
Edwards Lifesciences ($EW) scored a major victory against competitor Medtronic ($MDT) in an ongoing patent war over the companies' transcatheter aortic valve replacement (TAVR) products. A U.S. District Court issued a preliminary injunction against Medtronic's CoreValve system, limiting sales of the device in the U.S.
U.S. District Judge Gregory M. Sleet in Wilmington, DE, found that Medtronic's CoreValve product infringed on Edwards' Spenser patents for its Sapien XT transcatheter heart valve and granted the company's request for an injunction, Bloomberg reported. The preliminary court order will go into effect in 7 business days.
Sleet ordered the companies to confer on the continued use of the CoreValve system at medical centers where physicians are trained in the system. Minneapolis-based Medtronic plans to appeal the U.S. sales ban, according to Bloomberg.
The court order builds on two previous rulings, in which Irvine, CA-based Edwards also came out the winner. In 2010, a jury decided that Medtronic's CoreValve device infringed on one of Edwards' patents and awarded the company $74 million. The U.S. Supreme Court rejected Medtronic's efforts to overturn the heart valve patent loss in October 2013. In January, a U.S. District Court jury ordered the Minnesota device giant to cough up $394 million in damages, strengthening Edwards' hold on a $3 billion market.
The latest ruling also comes just weeks after Edwards' Sapien XT beat out Medtronic's CoreValve in the first head-to-head comparison of the companies' competing devices. An investigator-initiated study of 241 patients at 5 German hospitals found that Edwards' Sapien XT had a 95.9% success rate, compared with 77.5% for Medtronic's self-expandable valves. The products were designed to help an estimated 300,000 worldwide with aortic stenosis who cannot undergo open-heart surgery.
Courtesy of Medtronic
However, there may be some light at the end of the tunnel for Medtronic. The company won early FDA approval for CoreValve in January and continues to market its device in Europe. In March, the European Patent Office (EPO) invalidated and revoked Edwards' Spenser patent for its Sapien XT, allowing Medtronic to sell its product in Germany.
"Today's ruling has no impact on the sale or marketing of CoreValve outside of the United States or the use of CoreValve in the current U.S. clinical trials," Medtronic said in a statement following the recent court order. "The court stated that CoreValve is a 'safer device, and that patients in whom it is implanted have better outcomes with a lower risk of death.'"
- read the release
- here's the Bloomberg article