Regulatory Review Period Determination for Patent Extension: UNLOXCYT
AI-generated summary for informational purposes only. Not legal advice. See the original source for the authoritative text.
This notice from the FDA outlines the regulatory review period for the human biologic product UNLOXCYT, which impacts its patent extension eligibility. Specifically, it details the review phases totaling 2,000 days affecting patents held by Checkpoint Therapeutics, Inc., and invites public comments on the published dates.
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Key Changes
- Establishes the regulatory review period for UNLOXCYT totaling 2,000 days
- Impacts patent eligibility for extension held by Checkpoint Therapeutics, Inc.
- Invites public comments and petitions on regulatory review period determination
Obligations
What this law requires
Anyone with knowledge that any of the published dates are incorrect must submit comments and request for a redetermination by June 15, 2026.
Any interested person may petition the FDA regarding whether the applicant for patent extension acted with due diligence during the regulatory review period by October 13, 2026.
Comments must include the Docket Nos. FDA-2025-E-0501 and FDA-2025-E-0502 for 'Determination of Regulatory Review Period for Purposes of Patent Extension; UNLOXCYT.'
Submit written comments to the Dockets Management Staff at the FDA by mail/hand delivery/courier if they contain confidential information.
Petitions for redetermination must be filed in accordance with 21 CFR 10.20 and meet all requirement specified in §60.30.