Edward Reines, Weil, Gotshal & Manges partner (Jason Doiy)
SAN FRANCISCO — The Federal Circuit has stayed an injunction that medical device maker Medtronic had warned put patient lives at risk.
The court entered the stay without comment Monday in a 2-1 order. Judge Pauline Newman’s brief dissent said Medtronic Inc. and competitor Edwards LifeSciences Corp. appeared to have made enough progress toward a voluntary modification of the injunction late last week that a stay wasn’t necessary.
On April 11, U.S. District Judge Gregory Sleet of Delaware entered the injunction against Medtronic, blocking the company from selling its artificial heart valve, known as CoreValve. The stay is a big win for Medtronic and its appellate attorney, Edward Reines of Weil, Gotshal & Manges, who had argued the mere threat of an injunction—scheduled to take effect Tuesday—was already causing cancellations of potentially lifesaving medical procedures.
“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, head of Medtronic Structural Heart Business, in a written statement.
Sleet’s ruling set off a furor last week after he found that Medtronic’s CoreValve product is “safer” and presents a “lower risk of death” for many patients in need of artificial heart valves. But “the strong public interest favoring enforcement of patent rights” and Medtronic’s willful infringement of Edwards’ competing Sapien product compelled him to enjoin Medtronic from selling CoreValve devices.
The judge encouraged the parties to negotiate a “carve-out” for patients whose doctors recommend the CoreValve device for them, but stayed his order for only a week, even though the parties appeared far apart on any sort of compromise.
Medtronic filed an emergency motion for a stay to the U.S. Court of Appeals for the Federal Circuit, warning of a “calamity to public health,” while Edwards accused Medtronic of “scare tactics” and claimed the company had rebuffed its carve-out proposals.
By late last week a slight thaw emerged. Medtronic had proposed that physicians certify in writing that the patient is “best served” by the CoreValve device before implanting one. Edwards instead wanted a certification of “medical necessity.” But the company revealed Friday it had dropped that demand.
“The agreed certification form adopts Medtronic’s proposal for the standard of care and ensures that the preliminary injunction does not threaten patient safety,” Paul, Weiss, Rifkind, Wharton & Garrison partner Nicholas Groombridge wrote for Edwards, in a sur-reply brief opposing the stay.
“We have always made every effort to ensure patients receive the treatment they need and will continue to seek a durable solution that benefits physicians and their patients,” Edwards CEO Michael Mussallem said in a written statement.
Monday’s order from the Federal Circuit was issued by the same panel that heard Medtronic’s initial appeal from an infringement verdict against Medtronic. Ironically, the same three judges ordered Sleet to consider entering a permanent injunction against Medtronic in their 2012 opinion.
On Monday, Chief Judge Randall Rader and Judge Sharon Prost voted to stay Sleet’s order “pending further notice by this court.” The court has already set expedited briefing, to be completed by June.
Newman dissented. “I would deny the motion to stay subject to the terms of the recent agreement between Edwards and Medtronic that Medtronic may provide its devices pending this appeal,” she wrote.
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