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.
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.
Edwards won FDA approval in November 2011 for the Sapien TAVI system, and shortly thereafter applied for patent term reconsideration with the U.S. Patent & Trademark Office. The USPTO requested the FDA’s help in determining extension eligibility for the patent in question, U.S. Patent No. 5,411,552, titled "Valve prothesis for implantation in the body and a catheter for implanting such valve prothesis."
The medical device giant is asking that regulators extend its valve patent by 1,757 days, or about 4.8 years, according to the notice in the Federal Register.
The FDA opened up a public commenting period, which will close April 23, 2013, during which the agency will gather comments regarding Edwards and consider requests for redetermination of the regulatory review period calculation. Interested parties have until August 21, 2013 to further question Edwards’ "due diligence during the regulatory review period," the agency noted.