Patent Extensions Get Bureaucratic Tune-Up Over FDA Delays
Published Date: 11/19/2025
Notice
Summary
The USPTO is asking for public feedback on updating the paperwork for extending patent protection when FDA or USDA delays slow down approval of drugs, medical devices, or food additives. This update affects companies holding these patents and aims to keep the process smooth and fair. Comments are open until January 20, 2026, so don’t miss your chance to weigh in!
Analyzed Economic Effects
4 provisions identified: 1 benefits, 2 costs, 1 mixed.
Estimated time and dollar burden to respond
The USPTO estimates 903 annual respondents and 903 annual responses, totaling 6,807 burden hours and an estimated $3,042,729 in hourly cost burden; responses are expected to take about 1 to 25 hours each. The agency estimates total annual non-hour costs (filing fees and postage) of $489,431.
Filing fees for extension-related filings
The notice lists specific filing fees for extension-related items: Application to extend a patent under 35 U.S.C. 156 is $2,500 (estimated 134 responses); initial interim extension under 35 U.S.C. 156(d)(5) is $1,320 (4 responses); subsequent interim extension is $680 (3 responses); petition for reconsideration of patent term adjustment is $226 (622 responses); supplemental redetermination fee is $1,440 (4 responses); petition for reinstatement fee is $452 (1 response); petition to accord a filing date is $226 (1 response).
Patent-term extensions for regulated products
If you hold a patent for a drug, medical device, food additive, or color additive, you can apply to the USPTO to extend the patent term to compensate for FDA or USDA regulatory review delays. The application must identify the approved product, the patent and claims covering the product or its manufacture/use, and a brief description with dates of activities during the regulatory review period; a patent may be extended up to 5 years under 35 U.S.C. 156.
Right to petition reinstatement of reduced adjustment
If the USPTO reduces a granted patent term adjustment because an applicant failed to reasonably respond within three months to a USPTO communication, the applicant may petition for reinstatement of the reduced adjustment by showing that, despite all due care, they were unable to respond within the three-month period.
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Key Dates
Department and Agencies
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