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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.

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled,

3 SECTION 1. INTERIM PATENT EXTENSIONS.

4 Section 156(d) of title 35, United States Code, is

5 amended—

6 (1) in the second sentence of paragraph (1) by

7 striking ‘‘Such’’ and inserting ‘‘Except as provided

8 in paragraph (5), such’’; and

9 (2) by adding at the end the following new

10 paragraph:
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1 ‘‘(5)(A) If the owner of record of the patent or its

2 agent reasonably expects that the applicable regulatory re3 view period described in paragraph (1)(B)(ii), (2)(B)(ii),

4 (3)(B)(ii), (4)(B)(ii), or (5)(B)(ii) of subsection (g) that

5 began for a product that is the subject of such patent may

6 extend beyond the expiration of the patent term in effect,

7 the owner or its agent may submit an application to the

8 Commissioner for an interim extension during the period

9 beginning 6 months, and ending 30 days, before such term

10 is due to expire. The application shall contain—

11 ‘‘(i) the identity of the product subject to regu12 latory review and the Federal statute under which

13 such review is occurring;

14 ‘‘(ii) the identity of the patent for which interim

15 extension is being sought and the identity of each

16 claim of such patent which claims the product under

17 regulatory review or a method of using or manufac18 turing the product;

19 ‘‘(iii) information to enable the Commissioner

20 to determine under subsection (a)(1), (2), and (3)

21 the eligibility of a patent for extension;

22 ‘‘(iv) a brief description of the activities under23 taken by the applicant during the applicable regu24 latory review period to date with respect to the prod-
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1 uct under review and the significant dates applicable

2 to such activities; and

3 ‘‘(v) such patent or other information as the

4 Commissioner may require.

5 ‘‘(B) If the Commissioner determines that, except for

6 permission to market or use the product commercially, the

7 patent would be eligible for an extension of the patent

8 term under this section, the Commissioner shall publish

9 in the Federal Register a notice of such determination,

10 including the identity of the product under regulatory re11 view, and shall issue to the applicant a certificate of in12 terim extension for a period of not more than 1 year.

13 ‘‘(C) The owner of record of a patent, or its agent,

14 for which an interim extension has been granted under

15 subparagraph (B), may apply for not more than 4 subse16 quent interim extensions under this paragraph. Each such

17 subsequent application shall be made during the period be18 ginning 60 days before, and ending 30 days before, the

19 expiration of the preceding interim extension.

20 ‘‘(D) Each certificate of interim extension under this

21 paragraph shall be recorded in the official file of the pat22 ent and shall be considered part of the original patent.

23 ‘‘(E) Any interim extension granted under this para24 graph shall terminate at the end of the 60-day period be25 ginning on the date on which the product involved receives
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1 permission for commercial marketing or use, except that,

2 if within that 60-day period the applicant notifies the

3 Commissioner of such permission and submits any addi4 tional information under paragraph (1) of this subsection

5 not previously contained in the application for interim ex6 tension, the patent shall be further extended in accordance

7 with the provisions of this section, not to exceed 5 years

8 from the date of expiration of the original patent term.

9 ‘‘(F) The rights derived from any patent the term

10 of which is extended under this paragraph shall, during

11 the period of interim extension—

12 ‘‘(i) in the case of a patent which claims a

13 product, be limited to any use then under regulatory

14 review;

15 ‘‘(ii) in the case of a patent which claims a

16 method of using a product, be limited to any use

17 claimed by the patent then under regulatory review;

18 and

19 ‘‘(iii) in the case of a patent which claims a

20 method of manufacturing a product, be limited to

21 the method of manufacturing as used to make the

22 product then under regulatory review.’’.

23 SEC. 2. CONFORMING AMENDMENTS.

24 Section 156 of title 35, United States Code, is

25 amended—
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1 (1) in subsection (a)—

2 (A) in paragraph (1) by striking ‘‘(d)’’ and

3 inserting ‘‘(d)(1)’’; and

4 (B) in paragraph (3) by striking ‘‘sub5 section (d)’’ and inserting ‘‘paragraphs (1)

6 through (4) of subsection (d)’’;

7 (2) in subsection (b) by striking ‘‘The rights’’

8 and inserting ‘‘Except as provided in subsection

9 (d)(5)(F), the rights’’; and

10 (3) in subsection (e)—

11 (A) in paragraph (1) by striking ‘‘sub12 section (d)’’ and inserting ‘‘paragraphs (1)

13 through (4) of subsection (d)’’; and

14 (B) in paragraph (2) by striking ‘‘(d)’’ and

15 inserting ‘‘(d)(1)’’.

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