Code of Federal Regulations Title 37. Patents, Trademarks, and Copyrights § 37.1.791 Termination of interim extension granted prior to regulatory approval of a product for commercial marketing or use

Any interim extension granted under 35 U.S.C. 156(d)(5) terminates at the end of the 60–day period beginning on the date on which the product involved receives permission for commercial marketing or use. If within that 60–day period the patent owner or its agent files an application for extension under §§ 1.740 and 1.741 including any additional information required under 35 U.S.C. 156(d)(1) not contained in the application for interim extension, the patent shall be further extended in accordance with the provisions of 35 U.S.C. 156.