April 16, 2014 — The U.S. District Court for the District of Delaware granted a preliminary injunction limiting the sale of Medtronic's CoreValve transcatheter aortic valve replacement (TAVR) system in the United States. The court ordered the injunction April 10, which will go into effect the Week of April 21.
At Medtronic's request, the Federal District Court agreed to postpone the implementation of the order for seven business days to allow Medtronic to seek prompt relief from the Federal Circuit Court of Appeals. Medtronic is appealing the court's injunction, and intends to ask the Federal Circuit Court of Appeals to prevent it from going into effect until it determines if the injunction was properly issued.
The decision stems from a federal jury decision in 2010 that CoreValve willfully infringed on patent use for the Edwards Lifesciences Corp. U.S. 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. The companies are to agree 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 the Edwards’ Sapien device) free from the limitations of the injunction. 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.”
Medtronic said the 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.
Edwards initiated this case in 2008. On April 1, 2010, a federal jury found Medtronic willfully infringed Edwards' U.S. Andersen patent and awarded damages. In November 2012, the U.S. Court of Appeals for the Federal Circuit affirmed the jury decision. In October 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 U.S. Andersen patent was issued in 1995. A petition has been filed with the U.S. 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' U.S. Cribier transcatheter heart valve patent, and awarded damages to Edwards in that trial.
The Edwards’ Sapien TAVR system was the first to gain U.S. Food and Drug Administration (FDA) clearance in November 2011. The Medtronic CoreValve gained FDA approval this past January as the second TAVR device on the U.S. market. Many observers view the lawsuits by Edwards as a way to prevent competition in the U.S. market, similar to the suits and counter suits involved with drug-eluting stent manufactures in the United States over the past decade. Edwards filed similar suits in Europe after both valves gained market clearance there. Those suits have been ongoing for years.
The CoreValve System received FDA approval in January for patients at extreme risk for surgical valve replacement. Prior to that date, CoreValve therapy was available to extreme risk patients who were eligible to participate in the U.S. clinical trial. The CoreValve System is not yet approved in the U.S. for other patient groups.
In clinical trial data, the CoreValve appears to have better outcomes than that of the Sapien valve. At the American College of Cardiology (ACC) annual meeting in March, late-breaking trial data stated that the CoreValve actually out-performed surgical valve replacement despite the inexperience of the CoreValve operators with the device. The CoreValve U.S. pivotal high-risk patient trial showed the Medtronic self-expanding CoreValve device had a 26 percent survival benefit above the surgical valve implant patients. In the same patient population, the Edwards Sapien was found to be equal to surgery, but was not superior to surgery.