Page:United States Statutes at Large Volume 107 Part 3.djvu/103

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PUBLIC LAW 103-179—DEC. 3, 1993 107 STAT. 2041 "(5)(A) If the owner of record of the patent or its agent reasonably expects that the applicable regulatory review period described in paragraph (IXBXii), (2)(B)(ii), OXBXii), (4)(B)(ii), or (SXBXii) of subsection (g) that began for a product that is the subject of such patent may extend beyond the expiration of the patent term in effect, the owner or its agent may submit an application to the Commissioner for an interim extension during the period beginning 6 months, and ending 15 days, before such term is due to expire. The application shall contain— "(i) the identity of the product subject to regulatory review and the Federal statute under which such review is occurring; "(ii) the identity of the patent for which interim extension is being sought and the identity of each claim of such patent which claims the product under regulatory review or a method of using or manufacturing the product; "(iii) information to enable the Commissioner to determine under subsection (a)(D, (2), and (3) the eligibility of a patent for extension; ' "(iv) a brief description of the activities undertaken by the applicant during the applicable regulatory review period to date with respect to the product under review and the significant dates applicable to such activities; and "(v) such patent or other information as the Commissioner may require. "(B) If the Commissioner determines that, except for permission Federal to market or use the product commercially, the patent would be uhir^ti eligible for an extension of the patent term under this section, ^" the Commissioner shall publish in the Federal Register a notice of such determination, including the identity of the product under regulatory review, and shall issue to the applicant a certificate of interim extension for a period of not more than 1 year. "(C) The owner of record of a patent, or its agent, for which an interim extension has been granted under subparagraph (B), may apply for not more than 4 subsequent interim extensions under this paragraph, except that, in the case of a patent subject to subsection (g)(6)(C), the owner of record of the patent, or its agent, may apply for only 1 subsequent interim extension under this paragraph. Each such subsequent application shall be made during the period beginning 60 days before, and ending 30 days before, the expiration of the preceding interim extension. "(D) Each certificate of interim extension under this paragraph shall be recorded in the official file of the patent and shall be considered part of the original patent. "(E) Any interim extension granted under this paragraph shall terminate at the end of the 60-day period beginning on the date on which the product involved receives permission for commercial marketing or use, except that, if within that 60-day period the applicant notifies the Commissioner of such permission and submits any additional infomnation under paragraph (1) of this subsection not previously contained in the application for interim extension, the patent shall be further extended, in accordance with the provisions of this section— "(i) for not to exceed 5 years from the date of expiration of the ori^nal patent term; or "(ii) if the patent is subject to subsection (g)(6)(C), from the date on which the product involved receives approval for commercial marketing or use.