CoreValve 'Willfully Infringes' on Edwards's TAVR Patent: Federal Court

Shelley Wood

January 15, 2014

IRVINE, CA — A federal jury has found that Medtronic's CoreValve transcatheter valve infringes on Edwards Lifesciences' Cribier transcatheter heart valve patent, Edwards announced today, adding that it will move to enforce the verdict and seek a permanent injunction[1].

In finding the Cribier patent valid, the jury also awarded Edwards $394 million in damages, the press release states. The "willfulness" aspect of the ruling further permits Edwards to additionally seek up to three times the damages amount, plus coverage of the company's legal fees.

Edwards has iterations of an FDA-approved transcatheter valve, the Sapien, on the market in the US; the CoreValve is approved in Europe but not in the US, although US approval is widely anticipated for early 2014. Last year, the FDA announced it would not be requiring an advisory committee to weigh in on whether the data supporting approval, largely from the CoreValve Extreme Risk trial, is sufficient.

Medtronic says it plans to appeal the ruling[2] and oppose an injunction request by Edwards. In a press release issued today, Medtronic gives a slightly different number for total damages—$392.5—and notes that it has "prevailed against Edwards in several legal actions related to a European counterpart to this patent and others."

The release adds that the company anticipates US approval of the CoreValve before April 2014 and still intends to sell its device in the US at that time.

The Cribier patent at the heart of today's announcement expires in December 2017.

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