FDA Sets Patent Review Clock for NAVITOR Heart Valve
Published Date: 6/16/2025
Notice
Summary
The FDA has officially set the review period for the NAVITOR Transcatheter Aortic Valve Implant, a medical device patent up for extension. This means the company can apply to extend their patent protection based on how long the FDA took to review the device. If anyone thinks the dates are wrong or wants to challenge the company's review speed, they have until mid-December 2025 to speak up.
Analyzed Economic Effects
2 provisions identified: 2 benefits, 0 costs, 0 mixed.
NAVITOR patent eligible for extension
The FDA determined the NAVITOR Transcatheter Aortic Valve Implant had a 453-day regulatory review period. FDA verified the PMA was initially submitted on October 18, 2021 and approved on January 13, 2023, and the applicant (St. Jude Medical, LLC) seeks 453 days of patent term extension. This determination establishes the maximum potential length of a patent extension, while the U.S. Patent and Trademark Office will apply statutory limits when calculating the actual extension.
Deadlines to challenge dates or due diligence
Anyone who believes the published dates are incorrect may submit comments asking for a redetermination by August 15, 2025. Any interested person may petition FDA about whether the applicant acted with due diligence during the regulatory review period by December 15, 2025, using the submission routes described (electronic to https://www.regulations.gov or written to the Dockets Management Staff).
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