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[Congressional Bills 103th Congress]
[From the U.S. Government Publishing Office]
[H.R. 4151 Introduced in House (IH)]

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.

    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, in 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 provisions 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.

                                 <all>
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