United States Code/Title 35/Chapter 14/Section 155
Section 155. Patent term extension
Notwithstanding the provisions of section 154, the term of a patent which encompasses within its scope a composition of matter or a process for using such composition shall be extended if such composition or process has been subjected to a regulatory review by the Federal Food and Drug Administration pursuant to the Federal Food, Drug, and Cosmetic Act leading to the publication of regulation permitting the interstate distribution and sale of such composition or process and for which there has thereafter been a stay of regulation of approval imposed pursuant to section 409 of the Federal Food, Drug, and Cosmetic Act which stay was in effect on January 1, 1981, by a length of time to be measured from the date such stay of regulation of approval was imposed until such proceedings are finally resolved and commercial marketing permitted. The patentee, his heirs, successors or assigns shall notify the Director within ninety days of the date of enactment of this section or the date the stay of regulation of approval has been removed, whichever is later, of the number of the patent to be extended and the date the stay was imposed and the date commercial marketing was permitted. On receipt of such notice, the Director shall promptly issue to the owner of record of the patent a certificate of extension, under seal, stating the fact and length of the extension and identifying the composition of matter or process for using such composition to which such extension is applicable. Such certificate shall be recorded in the official file of each patent extended and such certificate shall be considered as part of the original patent, and an appropriate notice shall be published in the Official Gazette of the Patent and Trademark Office.
Source[edit]
(Added Pub. L. 97-414, Sec. 11(a), Jan. 4, 1983, 96 Stat. 2065; amended Pub. L. 106-113, div. B, Sec. 1000(a)(9) [title IV, Sec. 4732(a)(6), (10)(A)], Nov. 29, 1999, 113 Stat. 1536, 1501A-582; Pub. L. 107-273, div. C, title III, Sec. 13206(b)(1)(B), Nov. 2, 2002, 116 Stat. 1906.)
References in Text[edit]
The Federal Food, Drug, and Cosmetic Act, referred to in text, is act June 25, 1938, ch. 675, 52 Stat. 1040, as amended, which is classified generally to chapter 9 (Sec. 301 et seq.) of Title 21, Food and Drugs. Section 409 of the Federal Food, Drug, and Cosmetic Act is classified to section 348 of Title 21. For complete classification of this Act to the Code, see section 301 of Title 21 and Tables.
Date of enactment of this section, referred to in text, means date of enactment of Pub. L. 97-414, which was approved Jan. 4, 1983.
Amendments[edit]
2002[edit]
Pub. L. 107-273 made technical correction to directory language of Pub. L. 106-113, Sec. 1000(a)(9) [title IV, Sec. 4732(a)(10)(A)]. See 1999 Amendment note below.
1999[edit]
Pub. L. 106-113, Sec. 1000(a)(9) [title IV, Sec. 4732(a)(10)(A)], as amended by Pub. L. 107-273, substituted “Director shall promptly” for “Commissioner shall promptly”.
Pub. L. 106-113, Sec. 1000(a)(9) [title IV, Sec. 4732(a)(6)], substituted “notify the Director” for “notify the Commissioner of Patents and Trademarks”.
Effective Date of 1999 Amendment[edit]
Amendment by Pub. L. 106-113 effective 4 months after Nov. 29, 1999, see section 1000(a)(9) [title IV, Sec. 4731] of Pub. L. 106-113, set out as a note under section 1 of this title.