Judge limits sale of CoreValve but grants delay

A federal court called for a preliminary injunction limiting the sale of the CoreValve device in the U.S. but granted a reprieve before the injunction is scheduled to go into effect.

Edwards Lifesciences, maker of the Sapien valve, and Medtronic, maker of CoreValve, have been in an extended patent battle over the two transcatheter aortic valve replacement (TAVR) devices. The valves are the only two products approved by the FDA as a treatment for inoperable patients with severe aortic stenosis.

The Sapien valve also has been approved for use in high-risk patients. Results for the CoreValve as a treatment in a similar patient population found TAVR with CoreValve was superior to treatment with standard care. The findings were presented at the recent American College of Cardiology scientific session. CoreValve remains an investigational device only for patients deemed at high risk for open-heart surgery.

Federal District Court of Delaware Chief Judge Gregory Sleet on April 11 granted the preliminary injunction. The judge also allowed for a postponement of seven business days before the injunction goes into effect.

On April 14, Medtronic filed an emergency motion to stay the preliminary injunction and expedite an appeal. “A stay should be entered and this appeal expedited because, if the injunction were permitted to go into effect, treatable patients may unnecessarily die in the name of already expired patent rights. Put simply, the calamity to public health that would result from the injunction is premised on a legally improper extension of patent rights,” it claimed in its filing.

Medtronic said in a release that it asked for the postponement to continue until it “determines if the injunction was properly issued.”

The dispute over patents is one of several between the two companies. This case involves Edwards’ Andersen family of heart valve patents; the Andersen patent was granted in 1995. Edwards charged in 2008 that Medtronic infringed on the patent, and in 2010 a federal jury ruled in favor of Edwards, which was upheld on appeal. Edwards has requested a patent extension into early 2016.

Sleet ordered the two companies to discuss in what circumstances the CoreValve would continue to be used in the U.S. Medtronic said the judge’s ruling would not affect use of CoreValve in current clinical trials. 

Edwards is based in based in Irvine, Calif., and Medtronic in Minneapolis.