I

103D CONGRESS

2D SESSION H. R. 4151

To amend title 35, United States Code, to provide for the compulsory licensing

of the patents for certain products which have not been commercially

marketed or used.

IN THE HOUSE OF REPRESENTATIVES

MARCH 24, 1994

Mr. NADLER introduced the following bill; which was referred to the

Committee on the Judiciary

A BILL

To amend title 35, United States Code, to provide for the

compulsory licensing of the patents for certain products

which have not been commercially marketed or used.

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

3 SECTION 1. SHORT TITLE.

4 This Act may be cited as the ‘‘Essential Pharma5 ceuticals Act of 1994’’.

6 SEC. 2. COMPULSORY LICENSING OF PATENTS.

7 (a) IN GENERAL.—Chapter 14 of title 35, United

8 States Code, is amended by adding at the end the

9 following:
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1 ‘‘§ 158. Compulsory licensing of certain patents

2 ‘‘(a) DETERMINATION BY SECRETARY OF HEALTH

3 AND HUMAN SERVICES.—In any case in which the Sec4 retary of Health and Human Services determines, after

5 notice and an opportunity for an agency hearing, that—

6 ‘‘(1) the owner of a patent which—

7 ‘‘(A) claims a product, a method of using

8 a product, or a method of manufacturing a

9 product, and

10 ‘‘(B) may be extended under section 156 of

11 this title,

12 has not taken all reasonable steps toward the com13 mercial marketing or use of that product, if the

14 product is not already so marketed or used, and

15 ‘‘(2) the availability of the product to the public

16 is of vital importance to the public health or welfare,

17 the Secretary shall notify the Commissioner of the

18 Secretary’s determination.

19 ‘‘(b) COMPULSORY LICENSING OF PATENT.—

20 ‘‘(1) IN GENERAL.—Upon receiving a notifica21 tion from the Secretary of Health and Human Serv22 ices under subsection (a) with respect to a product,

23 the Commissioner shall provide for the compulsory

24 licensing of all patents relating to that product, in

25 accordance with this section.
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1 ‘‘(2) REGULATIONS.—The Commissioner shall

2 issue regulations providing for the compulsory li3 censing of patents under this section. Such regula4 tions—

5 ‘‘(A) shall provide for—

6 ‘‘(i) the payment to the Commissioner

7 of fees for the use of any such patent, in

8 such manner and in such amounts as the

9 Commissioner may prescribe; and

10 ‘‘(ii) the distribution of such fees to

11 the patent holders, in such manner and at

12 such times as the Commissioner may pre13 scribe; and

14 ‘‘(B) may require the keeping of such

15 records, and the submission of such reports, as

16 the Commissioner considers necessary to carry

17 out this section.

18 ‘‘(c) APPEALS.—

19 ‘‘(1) TO BOARD OF PATENT APPEALS AND

20 INTERFERENCES.—Any person aggrieved by a deci21 sion of the Commissioner under this section may ap22 peal that decision to the Board of Patent Appeals

23 and Interferences, after having paid the fee for such

24 appeal.
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1 ‘‘(2) TO COURT OF APPEALS FOR THE FEDERAL

2 CIRCUIT.—A person aggrieved by a decision of the

3 Board of Patent Appeals and Interferences under

4 paragraph (1) may appeal that decision to the Unit5 ed States Court of Appeals for the Federal Circuit.

6 The provisions of sections 142 and 143 of this title

7 shall apply to an appeal under this subsection to the

8 same extent as such sections apply to an appeal

9 under section 141 of this title.’’

10 (b) CONFORMING AMENDMENTS.—(1) The table of

11 sections at the beginning of chapter 14 of title 35, United

12 States Code, is amended by adding at the end the follow13 ing new item:

‘‘158. Compulsory licensing of certain patents.’’.

14 (2) Section 1295(a)(4) of title 28, United States

15 Code, is amended—

16 (1) by redesignating subparagraphs (B) and

17 (C) as subparagraphs (C) and (D), respectively; and

18 (2) by inserting after subparagraph (A) the

19 following:

20 ‘‘(B) the Board of Patent Appeals and

21 Interferences of the Patent and Trademark

22 Office under section 158(c)(1) of title 35;’’.
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1 SEC. 3. APPLICABILITY.

2 The amendments made by this Act shall apply with

3 respect to patents issued before, on, or after the date of

4 the enactment of this Act.

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