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Medtronic Loses Latest Battle With Edwards in TAVR War


Posted in Cardiovascular by Jamie Hartford on April 14, 2014

Edwards Lifesciences won a preliminary injunction limiting sales of Medtronic's CoreValve TAVR product in the United States, but Medtronic has appealed the ruling.


Less than a month ago, analysts crowned Medtronic the “clear winner” in the race to dominate the transcatheter aortic valve replacement (TAVR) market, but a surprise twist may have opened the door for Edwards Lifesciences to stage a comeback.

Learn how to design next-generation medical devices in a conference session at MD&M East on June 9, 2014, in New York City.

Last Friday Edwards won a preliminary injunction limiting sales of Medtronic’s CoreValve TAVR product in the United States. The ruling follows a 2010 federal jury decision that Medtronic’s CoreValve infringes Edwards’s U.S. Andersen transcatheter heart valve patent.

“Given how rare injunctions are in the U.S., we are surprised by the court’s decision,” Glenn Novarro, an analyst with RBC Capital Markets, wrote in a research report.

The injunction is set to begin April 22, but chief judge Gregory Sleet, of the U.S. District Court for the District of Delaware, ordered the companies to come to terms that would allow the CoreValve to continue to be used at centers already trained to implant the device.

“Based on [Edwards's] actions in Germany, however, it would not surprise us to see [Edwards] remove [Medtronic] from the U.S. market,” Novarro wrote. “As a result, we believe that the best chance for [Medtronic] to remain in the U.S. market is to gain a stay from the Circuit Court of Appeals.”

Medtronic has vowed to appeal the injunction, and the company said in a press release that it will ask the Circuit Court of Appeals to prevent the ruling from going into effect until it determines whether the injunction was properly issued.

There was one bright spot for the company, though: The judge said in his ruling that CoreValve is a “safer device, and that patients in whom it is implanted have better outcomes with a lower risk of death.”

Novarro posited three possible outcomes to this latest development in the Edwards vs. Medtronic TAVR war:

  • Medtronic gains a stay of the injunction before April 22, then moves forward with an appeal, which will take 1–2 years to play out in court.
  • Medtronic does not gain a stay of the injunction before April 22, and Edwards enforces the injunction. Edwards already has a petition into the U.S. Patent and Trademark office to extend its patent into early 2016, so in a worst-case scenario Medtronic’s CoreValve could remain off the market until then.
  • Medtronic does not gain a stay of the injunction, but Edwards allows the company to sell CoreValve to the roughly 60 hospitals already trained to implant it.

At midday, Edwards' stock price was up around 12% on the news, according to Seeking Alpha.

Update (April 14, 2:23 p.m. EST): Medtronic has filed an emergency motion with the Circuit Court of Appeals requesting an emergency stay of the preliminary injunction and moving to expedite the appeal. The company requests that the briefing be complete by June 19 and says it can file its principal appeal brief by May 12. Edwards has refused the company's request for a response by June 12, which would reduce the original response time by nine days, according to the appeal.

According to Medtronic's 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."  

Read the entire appeal here

Learn how to design next-generation medical devices in a conference session at MD&M East on June 9, 2014, in New York City.
 
Jamie Hartford, managing editor, MD+DI
jamie.hartford@ubm.com

[image courtesy of MEDTRONIC]


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