March 24, 1994

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

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.

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

SECTION 1. SHORT TITLE.

This Act may be cited as the `Essential Pharmaceuticals Act of 1994'.

SEC. 2. COMPULSORY LICENSING OF PATENTS.

(a) IN GENERAL- Chapter 14 of title 35, United States Code, is amended by adding at the end the following:

`Sec. 158. Compulsory licensing of certain patents

`(a) DETERMINATION BY SECRETARY OF HEALTH AND HUMAN SERVICES- In any case in which the Secretary of Health and Human Services determines, after notice and an opportunity for an agency hearing, that--

`(1) the owner of a patent which--

`(A) claims a product, a method of using a product, or a method of manufacturing a product, and

`(B) may be extended under section 156 of this title,

has not taken all reasonable steps toward the commercial marketing or use of that product, if the product is not already so marketed or used, and

`(2) the availability of the product to the public is of vital importance to the public health or welfare,

the Secretary shall notify the Commissioner of the Secretary's determination.

`(b) COMPULSORY LICENSING OF PATENT-

`(1) IN GENERAL- Upon receiving a notification from the Secretary of Health and Human Services under subsection (a) with respect to a product, the Commissioner shall provide for the compulsory licensing of all patents relating to that product, i n accordance with this section.

`(2) REGULATIONS- The Commissioner shall issue regulations providing for the compulsory licensing of patents under this section. Such regulations--

`(A) shall provide for--

`(i) the payment to the Commissioner of fees for the use of any such patent, in such manner and in such amounts as the Commissioner may prescribe; and

`(ii) the distribution of such fees to the patent holders, in such manner and at such times as the Commissioner may prescribe; and

`(B) may require the keeping of such records, and the submission of such reports, as the Commissioner considers necessary to carry out this section.

`(c) APPEALS-

`(1) TO BOARD OF PATENT APPEALS AND INTERFERENCES- Any person aggrieved by a decision of the Commissioner under this section may appeal that decision to the Board of Patent Appeals and Interferences, after having paid the fee for such appeal.
`(2) TO COURT OF APPEALS FOR THE FEDERAL CIRCUIT- A person aggrieved by a decision of the Board of Patent Appeals and Interferences under paragraph (1) may appeal that decision to the United States Court of Appeals for the Federal Circuit. The p rovisions of sections 142 and 143 of this title shall apply to an appeal under this subsection to the same extent as such sections apply to an appeal under section 141 of this title.'
(b) CONFORMING AMENDMENTS- (1) The table of sections at the beginning of chapter 14 of title 35, United States Code, is amended by adding at the end the following new item:
`158. Compulsory licensing of certain patents.'.
(2) Section 1295(a)(4) of title 28, United States Code, is amended--
(1) by redesignating subparagraphs (B) and (C) as subparagraphs (C) and (D), respectively; and
(2) by inserting after subparagraph (A) the following:
`(B) the Board of Patent Appeals and Interferences of the Patent and Trademark Office under section 158(c)(1) of title 35;'.

SEC. 3. APPLICABILITY.

The amendments made by this Act shall apply with respect to patents issued before, on, or after the date of the enactment of this Act.

END