Patents - 35 USC Section 155A

01/19/04

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.

Last modified: April 19, 2006