HPV Detection Patent Gets FDA Limbo Extension
Published Date: 11/28/2025
Notice
Summary
Gen-Probe Inc. just scored a one-year interim extension on their U.S. Patent for the Aptima® HPV Assay with the Panther® System because FDA approval is still in progress. This means the patent now lasts longer, giving the company more time to protect and profit from their medical device. The extension kicks in right after the original patent expires on December 8, 2025.
Analyzed Economic Effects
1 provisions identified: 1 benefits, 0 costs, 0 mixed.
One-Year Patent Extension Granted
The U.S. Patent and Trademark Office granted a one-year interim extension of U.S. Patent No. 8,785,125 for the Aptima® HPV Assay with the Panther® System. The extension begins at the patent's original expiration date, December 8, 2025, and lasts one year (through December 8, 2026), under 35 U.S.C. 156(d)(5) because FDA approval (PMA 100042/S038) is still pending.
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