[Congressional Bills 103th Congress]
[From the U.S. Government Publishing Office]
[S. 387 Introduced in Senate (IS)]

103d CONGRESS
  1st Session
                                 S. 387

To amend title 35, United States Code, to impose a 2-year moratorium on 
the patenting of certain human tissues and organs, on human gene cells 
and on animal organisms, in order to provide time for Congress to fully 
assess, consider and respond to the economic, environmental and ethical 
    issues raised by the patenting of such entities, and for other 
                               purposes.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

             February 18 (legislative day, January 5), 1993

 Mr. Hatfield introduced the following bill; which was read twice and 
               referred to the Committee on the Judiciary

_______________________________________________________________________

                                 A BILL


 
To amend title 35, United States Code, to impose a 2-year moratorium on 
the patenting of certain human tissues and organs, on human gene cells 
and on animal organisms, in order to provide time for Congress to fully 
assess, consider and respond to the economic, environmental and ethical 
    issues raised by the patenting of such entities, and for other 
                               purposes.

    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 ``Life Patenting Moratorium Act of 
1993''.

SEC. 2. FINDINGS.

    The Congress finds the following:
            (1) The rapid advances in biotechnology and biomedical 
        research capabilities are creating a wide range of ethical, 
        legal, economic, environmental, international and social 
        issues, including concerns about the patenting of life forms, 
        eugenics, genetic discrimination, conflicts of interest for 
        biomedical researchers, and genetic privacy considerations in 
        insurance and employment.
            (2) Prominent members of the scientific community are 
        discussing the possibility of the permanent alteration of the 
        genetic code of human beings (referred to as ``germ-line 
        research''), yet Congress has not yet addressed the ethical, 
        legal, economic, environmental, evolutionary, international and 
        social implications of such experimentation.
            (3) The National Institutes of Health has already proposed 
        patenting over 2,000 human gene sequences, an issue which 
        raises unique and unprecedented ethical, legal, economic and 
        social questions.
            (4) Prior to the Patent and Trademark Office policy of 
        patenting animals, established on April 7, 1987, no animal had 
        ever been patented under the patent laws of the United States.
            (5) Over 150 animal patents are presently pending and three 
        more were granted by the Patent and Trademark Office of the 
        Department of Commerce in December of 1992, in spite of the 
        undetermined ethical implications of such patents.
            (6) Congress may act to significantly restrict or alter the 
        Patent and Trademark Office policy of patenting animals and 
        human genes.
            (7) The Office of Technology Assessment will complete a 
        comprehensive review of these issues, and the Congress is 
        prepared to schedule hearings and debate on this issue in the 
        spring of 1993.

SEC. 3. RESTRICTION ON THE ISSUANCE OF PATENTS.

    (a) In General.--Chapter 10 of part II of title 35, United States 
Code, is amended by adding at the end thereof the following new 
section:
``Sec. 106. Prohibition on Patentability of Certain Biomedical 
              Inventions or Processes
    ``(a) In General.--No human being, human organ, organ subpart 
(genetically engineered or otherwise) or genetically engineered animal 
shall be considered patentable subject matter under this title.
    ``(b) Suspension.--Except as otherwise provided in section, during 
the 2-year period beginning on the date of enactment of this section, 
no--
            ``(1) human tissue, fluid, cell, gene or gene sequence 
        (genetically engineered or otherwise); or
            ``(2) animal or animal organism (genetically engineered or 
        otherwise);
shall be considered patentable subject matter under this title. The 
prohibition under this section may continue after such 2-year period 
pursuant to section 381(f) of the Public Health Service Act.
    ``(c) Exception.--Subsection (b) shall not apply to patents issued 
prior to the date of enactment of this section.
    ``(d) Patent Status of Others.--Notwithstanding any other provision 
of law, with respect to those individuals who have applied or will 
apply for a patent to which this section applies, this section shall 
not be construed to detrimentally affect the rights of such 
individuals, but rather to maintain such rights until the expiration of 
the 2-year period described in subsection (b).
    ``(e) Definitions.--As used in this section, the term `genetically 
engineered' means the formation of new combinations of genetic material 
by the insertion of nucleic acid molecules into the host organism's 
somatic or germ-line cells so as to allow the incorporation of the new 
genetic material into the genetic material of the host organism.''.
    (b) Conforming Amendment.--The table of sections for chapter 10 of 
part II of title 35, United States Code, is amended by adding at the 
end thereof the following:

``106. Prohibition on patentability of certain biomedical inventions or 
                            processes.''.

SEC. 4. SENSE OF THE CONGRESS.

    It is the sense of the Congress that--
            (1) mindful of the dangers inherent in the uncontrolled 
        patenting and proliferation of genetic material, including 
        problems in the areas of patenting of life, eugenics, genetic 
        discrimination, unexpected and reproducible mutations, 
        conflicts of interest for biomedical researchers, and genetic 
        privacy considerations in insurance and employment, but aware 
        of the urgent need of humanity to reap the benefits of 
        responsibly-conducted research and innovation, legislation 
        addressing the implications of genetic research should be 
        thoroughly studied, considered, debated and passed by the 
        Congress as soon as reasonably possible; and
            (2) the Department of Commerce, the National Institutes of 
        Health and the Department of State should work with the 
        international community to develop international standards 
        relating to the patenting of genetic information and access to 
        such information.

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