PUBLIC LAW 98-127—OCT. 13, 1983 97 STAT. 833 "(A) the Federal Food and Drug Administration notified the patentee, by letter dated February 20, 1976, that such product's new drug application was not approvable under section 505(b)(l) of the Federal Food, Drug and Cosmetic Act; "(B) in 1977 the patentee submitted to the Federal Food and Drug Administration the results of a health effects test to evaluate the carcinogenic potential of such product; "(C) the Federal Food and Drug Administration approved, by letter dated December 18, 1979, the new drug application for such product; and "(D) the Federal Food and Drug Administration approved, by letter dated May 26, 1981, a supplementary application covering the facility for the production of such product. "(2) Any patent which encompasses within its scope a process for using the composition of matter described in paragraph (1). "(b) The term of any patent described in subsection (a) shall be extended for a period equal to the period beginning February 20, 1976, and ending May 26, 1981, and such patent shall have the effect as if originally issued with such extended term. "(c) The patentee of any patent described in subsection (a) of this section shall, within ninety days after the date of enactment of this section, notify the Commissioner of Patents and Trademarks of the number of any patent so extended. On receipt of such notice, the Commissioner shall confirm such extension by placing a notice thereof in the official file of such patent and publishing an appropri- ate notice of such extension in the Official Gazette of the Patent and Trademark Office.". (b) The table of sections at the beginning of chapter 14 of such title 35 is amended by adding at the end thereof the following: "155A. Patent term restoration.". 21 USC 355. Extension. Notification of patent number. Extension confirmation. Approved October 13, 1983. LEGISLATIVE HISTORY—S. 216 (H.R. 2174): HOUSE REPORT No. 98 -93 accompanying H.R. 2174 (Comm. on the Judiciary). SENATE REPORT No. 98 -69 (Comm. on the Judiciary). CONGRESSIONAL RECORD, Vol. 129 (1983): May 9, H.R. 2174 considered and passed House; S. 216 considered and passed Senate. Sept. 29, considered and passed House, amended, in lieu of H.R. 2174. Sept. 30, Senate concurred in House amendments. WEEKLY COMPILATION OF PRESIDENTIAL DOCUMENTS, Vol. 19, No. 41 (1983): Oct. 14, Presidential statement. 11-194O-85~ 28:QL3
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