Medtronic Inc. and Edwards Lifesciences Corp. have reached a global settlement of their patent litigation, wiping out two large jury awards that had raised the threat of an injunction against potentially lifesaving heart valve technology.
Medtronic, which had been hit with infringement verdicts of $74 million in 2010 and $394 million in January, agreed to pay Edwards $750 million up front and royalties of at least $40 million a year for the next eight years.
The deal eliminates the threat of injunctions against Medtronic's CoreValve artificial heart valves, which the company had argued—and a judge had found—are a safer, and sometimes the only, option for certain patients.
Nevertheless, U.S. District Judge Gregory Sleet had issued a preliminary injunction in April based on the 2010 jury verdict. That order had been stayed by the Federal Circuit in light of settlement negotiations, and the parties had been scheduled to report back to Sleet on Wednesday.
Tuesday's deal will allow both companies to make their respective therapies available to physicians and patients "without the overhang of any potential injunction or additional damages," said John Liddicoat, president of the Structural Heart business at Medtronic, in a press release.
"This agreement allows us to move forward, fully dedicating our time and resources to helping patients," Michael Mussallem, CEO of Edwards, said in his company's press release.
The litigation has been hotly contested for six years. At stake is the fast-growing market for artificial valves that can be inserted via the transfemoral vein and inflated into place inside the aorta, without open-heart surgery. Though the devices were first approved by the Food and Drug Administration only three years ago, the market is already estimated to be worth $500 million in the U.S. Edwards' Sapien valve uses a balloon to expand once inserted into the aorta. Medtronic's is self-inflating.
At an April hearing Sleet acknowledged that Medtronic's product can be used on a wider variety of patients, and that it's "safer" and leads to "better outcomes with a lower risk of death." But at the same time, the judge said, Medtronic's infringement was "egregious" and "the court cannot downplay the strong public interest favoring enforcement of patent rights."
He enjoined Medtronic from marketing CoreValve in the U.S. while encouraging the parties to work out an agreement to let physicians choose either device based on patient need. The Federal Circuit stayed the injunction after Medtronic warned that "treatable patients may unnecessarily die in the name of already expired patent rights."
Separately, Edwards had asked Sleet for a permanent injunction in March, saying that Medtronic's ongoing infringement was costing it "market share, reputation, brand recognition, customer goodwill, and opportunities to train doctors and establish hospital accounts." The settlement ends the proceedings before Sleet and is expected to conclude litigation in California, Minnesota and Europe.
"It's a large legal dispute by anyone's standards with a lot of different fronts of the war," said Paul, Weiss, Rifkind, Wharton & Garrison partner Nicholas Groombridge, part of the team representing Edwards along with Morris, Nichols, Arsht & Tunnell. "It's good to see a resolution everyone can live with." Medtronic's outside counsel included Weil, Gotshal & Manges, Keker & Van Nest and Robins, Kaplan, Miller & Ciresi.