Patent Term Extension (PTE) Under 35 U.S.C. 156

PTE under 35 U.S.C. 156 enables the owners of patents that claim certain human drug products, medical device products, animal drug products, veterinary biological products, and food or color additive products to restore to the terms of those patents some of the time lost while awaiting premarket Government approval for the products from a regulatory agency. The right to PTE is the result of the Drug Price Competition and Patent Term Restoration Act of 1984, Public Law 98-417, 98 Stat. 1585 (codified at 21 U.S.C. 355(b), (j), (l); 35 U.S.C. 156271282) (Hatch-Waxman Act).

Learn more about PTE beginning at Chapter 2750 of the Manual of Patent Examining Procedure.


NOTE: Previous versions of this page contained a list of Patent Term Extensions under former Rule 155, which was repealed effective effective Sept. 16, 2012.