FDA considers patent extension for Edwards' Sapien TAVI heart implant

March 7, 2013 by Arezu Sarvestani

Federal healthcare regulators review Edwards Lifesciences request for an extension to patents for its Sapien transcatheter aortic valve implantation system, the only such device on the U.S. market.

Edwards Lifesciences Sapient patent drawings

Drawings from Edwards Lifesciences' U.S. Patent No. 5,411,552.

Medical device maker Edwards Lifesciences (NYSE:EW) is seeking an extension for patents related to its Sapien transcatheter aortic valve implantation technology, according to an FDA notice.

Federal healthcare regulators determined the "regulatory review period" that Edwards may use to request its patent extension to amount to 2,473 days, comprising 2,106 days of testing and 367 days of review. Only a portion of that time may be recouped, according to the FDA.

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By law, device makers can request a patent extension of up to 5 years for products subject to regulatory review prior to marketing, and the length of time the device spent under review determines the amount of time by which a patent may be extended, according to the agency.