§ 155. — Patent term extension.
[Laws in effect as of January 24, 2002]
[Document not affected by Public Laws enacted between
January 24, 2002 and December 19, 2002]
[CITE: 35USC155]
TITLE 35--PATENTS
PART II--PATENTABILITY OF INVENTIONS AND GRANT OF PATENTS
CHAPTER 14--ISSUE OF PATENT
Sec. 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.
(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
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
2002--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--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
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.
