35 U.S.C. § 155
Section 155 · Patent term extension
Amended 2 times on record
Applied in 6 court decisions — leading case Roche Products, Inc. v. Bolar Pharmaceutical Co. (1984)
Most recently applied in In re Yamazaki (December 2012)
How often courts cite this section
Court decisions citing this, by year.Markers show enactment, consequential amendments, and circuit splits over this section — watch for a citation surge after a change or a disagreement. The dip in the last several years is a data-coverage gap, not a real trend — our corpus holds fewer opinions from the most recent years, so recent citations are undercounted.
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.
Editorial notes U.S. Code · Office of the Law Revision Counsel
References in Text
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 (§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
1999—Pub. L. 106–113 substituted “notify the Director” for “notify the Commissioner of Patents and Trademarks” and “Director shall promptly” for “Commissioner shall promptly”.
Effective Date of 1999 Amendment
Amendment by Pub. L. 106–113 effective 4 months after Nov. 29, 1999, see section 1000(a)(9) [title IV, §4731] of Pub. L. 106–113, set out as a note under section 1 of this title.