§ 155A. — Patent term restoration.
[Laws in effect as of January 24, 2002]
[Document not affected by Public Laws enacted between
January 24, 2002 and December 19, 2002]
[CITE: 35USC155A]
TITLE 35--PATENTS
PART II--PATENTABILITY OF INVENTIONS AND GRANT OF PATENTS
CHAPTER 14--ISSUE OF PATENT
Sec. 155A. Patent term restoration
(a) Notwithstanding section 154 of this title, the term of each of
the following patents shall be extended in accordance with this section:
(1) Any patent which encompasses within its scope a composition
of matter which is a new drug product, if during the regulatory
review of the product by the Federal Food and Drug Administration--
(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)(1)
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 Director of the number of any patent so extended. On
receipt of such notice, the Director shall confirm such extension by
placing a notice thereof in the official file of such patent and
publishing an appropriate notice of such extension in the Official
Gazette of the Patent and Trademark Office.
(Added Pub. L. 98-127, Sec. 4(a), Oct. 13, 1983, 97 Stat. 832; amended
Pub. L. 106-113, div. B, Sec. 1000(a)(9) [title IV, Sec. 4732(a)(7),
(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
Section 505(b)(1) of the Federal Food, Drug and Cosmetic Act,
referred to in subsec. (a)(1)(A), is classified to section 355(b)(1) of
Title 21, Food and Drugs.
The date of enactment of this section, referred to in subsec. (c),
is the date of enactment of Pub. L. 98-127, which was approved Oct. 13,
1983.
Amendments
2002--Subsec. (c). 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--Subsec. (c). 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 confirm'' for ``Commissioner shall confirm''.
Pub. L. 106-113, Sec. 1000(a)(9) [title IV, Sec. 4732(a)(7)],
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.
