Patent Term Extension and Adjustment

The patent term restoration portion of the Drug Price Competition and Patent Term Restoration Act of 1984 (P.L. 98-417), which is codified at 35 U.S.C. 156, permits the USPTO to extend the term of protection under a patent to compensate for delay during regulatory review and approval by the Food and Drug Administration (FDA) or United States Department of Agriculture (USDA). Only patents for drug products, medical devices, food additives, or color additives are potentially eligible for extension. The maximum length that a patent may be extended under 35 U.S.C. 156 is 5 years. The USPTO administers 35 U.S.C. 156 through 37 CFR 1.710-1.791. Separate from the extension provisions of 35 U.S.C. 156, the USPTO may in some cases extend the term of an original patent due to certain delays in the prosecution of the patent application, including delays caused by interference proceedings, secrecy orders, or appellate review by the Patent Trial and Appeal Board or a Federal court in which the patent is issued pursuant to a decision reversing an adverse determination of patentability. The patent term provisions of 35 U.S.C. 154(b), as amended by Title IV, Subtitle D of the Intellectual Property and Communications Omnibus Reform Act of 1999, require the USPTO to notify the applicant of the patent term adjustment in the notice of allowance and give the applicant an opportunity to request reconsideration of the USPTO’s patent term adjustment determination. The USPTO administers 35 U.S.C. 154 through 37 CFR 1.701-1.705. The public uses this information collection to file requests related to patent term extensions and reconsideration or reinstatement of patent term adjustments. The information in this collection is used by the USPTO to consider whether an applicant is eligible for a patent term extension or reconsideration of a patent term adjustment and, if so, to determine the length of the patent term extension or adjustment.

The latest form for Patent Term Extension and Adjustment expires 2023-03-31 and can be found here.

Application to Extend Patent Term Under 35 U.S.C. 156

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