In the most recent round, a federal appeals court on April 21 postponed a trial judge's injunction that would have barred Medtronic from selling its CoreValve artificial aortic valve replacement in the U.S. The decision by the U.S. Court of Appeals for the Federal Circuit delays the injunction until further notice. A federal trial judge in Delaware had issued the injunction on April 11 in a continuing patent dispute between Medtronic and competitor Edwards found that Medtronic's CoreValve had infringed on a patent held by California company.
According to data presented by Medtronic during last month's American College of Cardiology annual meeting, its CoreValve system led to a significantly higher survival rate after one year than open heart surgery in patients deemed at high risk of death during surgery. CoreValve won U.S. Food and Drug Administration approval in January to treat patients considered too frail for open heart surgery, becoming the first such device to compete against Edwards' Sapien valve in the United States. The CoreValve System is not yet approved in the U.S. for other patient groups.
During the week of April 14, Medtronic officials asked the appeals court for an emergency stay of the injunction, arguing that the sales ban would place patients' lives at risk. The Federal Circuit, a Washington, D.C.-based court that hears patent appeals, didn't explain why it delayed the injunction. Medtronic's sale of the device and its training of doctors on how to use it will continue until the Appeals Court issues a final decision, which is expected sometime over the summer, according to a Medtronic spokesman her Garland said.The Edwards and Medtronic devices are implanted via a minimally invasive procedure and used to treat patients with diseased aortic valves who are too sick to undergo open-heart surgery. The devices are similar, but the Medtronic valve is available in a greater number of sizes and can be used in patients for whom the Edwards device isn't anatomically suitable.
"We believe this ruling is good news for patients who need the CoreValve device, and our primary objective has been to work closely with physicians to ensure that their patients are able to get the therapy they need," said John Liddicoat, M.D., senior vice president, Medtronic, and president of the Medtronic Structural Heart Business.
The appeals court has agreed to hear Medtronic's underlying appeal on a fast-track basis. Medtronic is arguing that Edwards' rights as a patent holder are limited because the original patent term expired in 2012. The U.S. Patent and Trademark Office has since issued three one-year interim extensions for the Edwards patent, but hasn't yet issued a final extension. Edwards argues that its patent continues to cover its device.
The companies were also ordered by the Delaware trial judge, Gregory M. Sleet, to negotiate a mechanism for Medtronic to supply CoreValve to patients for whom the Edwards device isn't appropriate. Those negotiations continue and aren't affected by the stay issued by the appeals court, according to Medtronic. The companies are required to report the status of their negotiations to Judge Sleet on May 21.
The ruling does not impact CoreValve sales outside the United States.