Judge Halts Use of Lifesaving Heart Valve

Judge Halts Use of Lifesaving Heart Valve Chief Judge Gregory Sleet, District of Delaware

SAN FRANCISCO — A Medtronic implantable heart valve may be “safer” and present a “lower risk of death,” but the company is willfully infringing a competitor’s version and therefore is being ordered off the market by a Delaware federal judge.

That had Medtronic’s attorney pleading for a stay from the U.S. Court of Appeals for the Federal Circuit on Monday in what he contends is literally a life-and-death case.

“According to the district court’s findings, the injunction would leave no or an inferior treatment option for many patients on the verge of death due to malfunctioning aortic valves,” wrote Weil, Gotshal & Manges partner Edward Reines, who is representing Medtronic on appeal. “Treatable patients may unnecessarily die in the name of already expired patent rights.”

U.S. District Judge Gregory Sleet entered the injunction Friday against Medtronic’s transcatheter aortic heart valves, which a jury found—and the Federal Circuit has already agreed—willfully infringed a version created by Edwards LifeSciences. Sleet acknowledged that Medtronic’s product, known as MCS, can be used on a wider variety of patients, that it’s “safer” and leads to “better outcomes with a lower risk of death.”

“At the same time,” Sleet said, “the court cannot downplay the strong public interest favoring enforcement of patent rights.” The judge enjoined Medtronic from marketing MCS devices in the U.S. and gave the parties a week to work out some kind of exception for patients who are ill-suited to the Edwards version.

That’s the right call from Edwards’ perspective. It says Medtronic has been flouting a jury’s finding of willful infringement and lying to the courts about its plan to drive Edwards out of the heart valve business, which it describes repeatedly in court filings as the company’s “lifeblood.” Even as Judge Sleet was entertaining briefing on an injunction last fall, Medtronic was touting to investors imminent FDA approval and “aggressive launch preparation” that explicitly targeted hospitals trained to use Edwards’ valves.

Edwards has no competitors for the device in the United States, though Medtronic’s has been used in clinical trials. Letting in Medtronic would cause “catastrophic harm” to Edwards, wrote Regina Murphy of Morris, Nichols, Arsht & Tunnell in a November brief supporting Edwards’ motion for preliminary injunction. Murphy is litigating the case with Morris Nichols partner Jack Blumenthal.

At issue is a patent on a self-expanding mechanical valve that can be inserted via the transfemoral vein to take the place of a diseased aortic valve. Medtronic, which obtained the product by acquiring CoreValve in 2009, argues that its product reduces the potential for rupture and stroke.

A jury ruled in 2010 that CoreValve and Medtronic were willfully infringing Edwards’ patent and awarded $74 million. Medtronic told Sleet a permanent injunction was unnecessary because Medtronic was moving manufacturing to Mexico. Edwards says that’s a lie, and that Medtronic continued to manufacture the valves in California. Medtronic says its U.S.-made valves only go to foreign countries that won’t accept implants from Mexico. The Federal Circuit ordered Sleet to reconsider imposing an injunction in 2012.

While motions were pending last fall, Medtronic announced that it expected FDA approval for high-risk patients by April. Edwards’ market value dropped by $760 million the next day. It sought an immediate preliminary injunction, which Sleet entered Friday.

“Edwards has outright prevailed in the litigation regarding the ’552 patent and the appeals process is over,” Sleet said Friday. Edwards faces irreparable harm in the form of lost market share and “price erosion.”

With regard to the public interest, Sleet found that some patients cannot use the Edwards products. Further, “The court is also convinced that the [MCS] is a safer device and that patients in whom it is implanted have better outcomes with a lower risk of death.”

So while enjoining Medtronic from infringing in the United States, Sleet ordered the companies to “immediately enter upon discussions to determine if they can agree on a mechanism” that will allow hospitals already trained on MCS to decide which devices to implant.

Medtronic argued to the Federal Circuit Monday that that’s unrealistic because physician case-by-case determinations won’t yield a bright-line rule needed for an injunction. Edwards is already being paid handsomely for its lost profits, Reines argued, and Sleet is interpreting an interim extension granted on the Edwards patent too expansively.

Meanwhile, patients who can’t accommodate the Edwards device but could have used the MCS will face “incising the chest and cutting through the heart to reach the aorta,” Reines wrote.

The Federal Circuit ordered Edwards to file a response to the stay motion by Thursday and set an expedited briefing schedule.

To Edwards, the injunction preserves the status quo while permitting “an orderly resolution of the remaining equitable issues,” according to Murphy’s brief last fall.

“Medtronic CoreValve is a willful infringer and has exhausted all appeals on its liability,” she wrote. “It cannot violate the law and then dictate the consequences.”

Contact the reporter at sgraham@alm.com.

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