Edwards Lifesciences has announced that the US District Court for the District of Delaware has granted a preliminary injunction limiting the sale of Medtronic's CoreValve system in the US.
The court ordered the injunction to go into effect in seven business days. The hearing related to a federal jury decision in 2010 that CoreValve willfully infringes Edwards’ US Andersen transcatheter aortic valve replacement patent.
At the conclusion of the hearing, Chief Judge Gregory Sleet ordered Edwards and Medtronic to confer on what instances the CoreValve device could continue to be used in the treatment of U.S. patients at centers currently trained on CoreValve.
There is a large body of evidence demonstrating the safety and performance of the Edwards SAPIEN valves, and the company remains committed to ensuring patients have appropriate access to transcatheter therapy.
This case was initiated by Edwards in 2008. On 1 April 2010, a federal jury found Medtronic willfully infringed Edwards’ US Andersen patent and awarded damages. In November 2012, the US Court of Appeals for the Federal Circuit affirmed the jury decision; in October 2013, the US Supreme Court declined to hear Medtronic’s appeal.
The patent involved in this suit is part of the Andersen family of patents. The US Andersen patent was issued in 1995. A petition has been filed with the US Patent and Trademark Office to extend this patent into early 2016.
In a separate case, a federal jury in January found that Medtronic CoreValve had willfully infringed Edwards’ US Cribier transcatheter heart valve patent, and awarded damages to Edwards in that trial.