Medtronic's CoreValve transcatheter aortic valve replacement device. (Courtesy Medtronic)
Almost before the judge's signature was dry on Friday's federal district court preliminary injunction in favor of Edwards Lifesciences Corp. (Irvine, CA) that will block Medtronic from selling its CoreValve System in the United States, the company issued a press release saying it would fight the ban.
The injunction, issued by Chief Judge Gregory Sleet of the US District Court for the District of Delaware, prevents Medtronic from selling or offering to sell its CoreValve System in the United States. The company says that this ruling has no impact on the sale or marketing of CoreValve outside of the United States, or the use of CoreValve in current US clinical trials.
Medtronic asked the Federal District Court for, and was granted, a seven-business-day postponement of the implementation of the court order to allow the company to seek "prompt relief" from the Federal Circuit Court of Appeals. Medtronic is appealing the district court's injunction, and intends to ask the federal appeals court to prevent it from going into effect until the appeals court can determine if the injunction was properly issued.
At the conclusion of the hearing, Judge Sleet ordered Edwards and Medtronic to confer on a mechanism that will enable physicians at facilities currently trained on CoreValve to make a clinical judgment as to which device to implant (CoreValve or Edwards Sapien device) free from the limitations of the injunction.
While Minneapolis-based Medtronic said in its release that, "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,'" Edwards' release announcing the injunction countered, "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."
Leading up to this injunction, in April, 2010, a federal jury found that Medtronic had willfully infringed Edwards' US Andersen patent and awarded damages. In Nov. 2012, the US Court of Appeals for the Federal Circuit affirmed the jury decision. Then in Oct. 2013, the U.S. 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, but Edwards has filed a petition with the US Patent and Trademark Office to extend this patent into early 2016.
In a case involving Edwards' US Cribier transcatheter heart valve patent, another federal jury in January found that Medtronic's CoreValve willfully infringed. Edwards was also awarded damages in that trial.
But in Europe, Medtronic has fared better. In March, the European Patent Office in The Hague declared another of Edwards' patents, the so-called Spenser patent, invalid in its entirety. This ruling squelched an attempt by Edwards to keep CoreValve off the market in Germany.
