I
103D CONGRESS
1ST SESSION
H. R. 3379
To amend section 156 of title 35, United States Code, to provide for the
interim extension of patents subject to that section.
IN THE HOUSE OF REPRESENTATIVES
OCTOBER 27, 1993
Mr. HUGHES introduced the following bill; which was referred to the
Committee on the Judiciary
A BILL
To amend section 156 of title 35, United States Code, to
provide for the interim extension of patents subject to
that section.
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled,
SECTION 1. INTERIM PATENT EXTENSIONS.
Section 156(d) of title 35, United States Code, is
amended—
(1) in the second sentence of paragraph (1) by
striking ‘‘Such’’ and inserting ‘‘Except as provided
in paragraph (5), such’’; and
(2) by adding at the end the following new
paragraph:
‘‘(5)(A) If the owner of record of the patent or its
agent reasonably expects that the applicable regulatory re-
view period described in paragraph (1)(B)(ii), (2)(B)(ii),
(3)(B)(ii), (4)(B)(ii), or (5)(B)(ii) of subsection (g) that
began for a product that is the subject of such patent may
extend beyond the expiration of the patent term in effect,
the owner or its agent may submit an application to the
Commissioner for an interim extension during the period
beginning 6 months, and ending 30 days, before such term
is due to expire. The application shall contain—
‘‘(i) the identity of the product subject to regu-
latory review and the Federal statute under which
such review is occurring;
‘‘(ii) the identity of the patent for which interim
extension is being sought and the identity of each
claim of such patent which claims the product under
regulatory review or a method of using or manufac-
turing the product;
‘‘(iii) information to enable the Commissioner
to determine under subsection (a)(1), (2), and (3)
the eligibility of a patent for extension;
‘‘(iv) a brief description of the activities under-
taken by the applicant during the applicable regu-
latory review period to date with respect to the prod-
uct under review and the significant dates applicable
to such activities; and
‘‘(v) such patent or other information as the
Commissioner may require.
‘‘(B) If the Commissioner determines that, except for
permission to market or use the product commercially, the
patent would be eligible for an extension of the patent
term under this section, the Commissioner shall publish
in the Federal Register a notice of such determination,
including the identity of the product under regulatory re-
view, and shall issue to the applicant a certificate of in-
terim extension for a period of not more than 1 year.
‘‘(C) The owner of record of a patent, or its agent,
for which an interim extension has been granted under
subparagraph (B), may apply for not more than 4 subse-
quent interim extensions under this paragraph. Each such
subsequent application shall be made during the period be-
ginning 60 days before, and ending 30 days before, the
expiration of the preceding interim extension.
‘‘(D) Each certificate of interim extension under this
paragraph shall be recorded in the official file of the pat-
ent and shall be considered part of the original patent.
‘‘(E) Any interim extension granted under this para-
graph shall terminate at the end of the 60-day period be-
ginning on the date on which the product involved receives
permission for commercial marketing or use, except that,
if within that 60-day period the applicant notifies the
Commissioner of such permission and submits any addi-
tional information under paragraph (1) of this subsection
not previously contained in the application for interim ex-
tension, the patent shall be further extended in accordance
with the provisions of this section, not to exceed 5 years
from the date of expiration of the original patent term.
‘‘(F) The rights derived from any patent the term
of which is extended under this paragraph shall, during
the period of interim extension—
‘‘(i) in the case of a patent which claims a
product, be limited to any use then under regulatory
review;
‘‘(ii) in the case of a patent which claims a
method of using a product, be limited to any use
claimed by the patent then under regulatory review;
and
‘‘(iii) in the case of a patent which claims a
method of manufacturing a product, be limited to
the method of manufacturing as used to make the
product then under regulatory review.’’.
SEC. 2. CONFORMING AMENDMENTS.
Section 156 of title 35, United States Code, is
amended—
(1) in subsection (a)—
(A) in paragraph (1) by striking ‘‘(d)’’ and
inserting ‘‘(d)(1)’’; and
(B) in paragraph (3) by striking ‘‘sub-
section (d)’’ and inserting ‘‘paragraphs (1)
through (4) of subsection (d)’’;
(2) in subsection (b) by striking ‘‘The rights’’
and inserting ‘‘Except as provided in subsection
(d)(5)(F), the rights’’; and
(3) in subsection (e)—
(A) in paragraph (1) by striking ‘‘sub-
section (d)’’ and inserting ‘‘paragraphs (1)
through (4) of subsection (d)’’; and
(B) in paragraph (2) by striking ‘‘(d)’’ and
inserting ‘‘(d)(1)’’.
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