[Congressional Bills 107th Congress]
[From the U.S. Government Publishing Office]
[H.R. 3967 Introduced in House (IH)]







107th CONGRESS
  2d Session
                                H. R. 3967

  To amend title 35, United States Code, to provide for noninfringing 
    uses of patents on genetic sequence information for purposes of 
    research and genetic diagnostic testing, and to require public 
     disclosure of such information in certain patent applications.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                             March 14, 2002

   Ms. Rivers (for herself and Mr. Weldon of Florida) 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 noninfringing 
    uses of patents on genetic sequence information for purposes of 
    research and genetic diagnostic testing, and to require public 
     disclosure of such information in certain patent applications.

    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 ``Genomic Research and Diagnostic 
Accessibility Act of 2002''.

SEC. 2. EXEMPTION FROM INFRINGEMENT FOR RESEARCH ON GENETIC SEQUENCE 
              INFORMATION.

    Section 271 of title 35, United States Code, is amended by adding 
at the end thereof the following new subsection:
    ``(j) Use of Genetic Sequence Information.--(1) It shall not be an 
act of infringement for any individual or entity to use any patent for 
or patented use of genetic sequence information for purposes of 
research. This paragraph shall not apply to any individual or entity 
that is directly engaged in the commercial manufacture, commercial 
sale, or commercial offer for sale of a drug, medical device, process, 
or other product using such patent for or patented use of genetic 
sequence information.
    ``(2) For purposes of this subsection--
            ``(A) the term `device' has the same meaning as defined in 
        section 201(h) of the Federal Food, Drug, and Cosmetic Act (21 
        U.S.C. 321(h));
            ``(B) the term `genetic sequence information' means any 
        ordered listing of nucleotides comprising a portion of an 
        organism's genetic code;
            ``(C) the term `drug' has the same meaning as defined in 
        section 201(g) of the Federal Food, Drug, and Cosmetic Act (21 
        U.S.C. 321(g));
            ``(D) the term `product' means a machine, manufacture, or 
        composition of matter or improvement thereof; and
            ``(E) the term `research' means a systematic investigation, 
        including research development, testing, and evaluation, 
        designed to develop or contribute to generalizable 
        knowledge.''.

SEC. 3. EXEMPTION FROM INFRINGEMENT REMEDIES FOR GENETIC DIAGNOSTIC 
              TESTING.

    (a) Exemption.--Section 287(c)(2) of title 35, United States Code, 
is amended--
            (1) by amending subparagraph (A) to read as follows:
            ``(A) the term `medical activity' means the performance of 
        a genetic diagnostic, prognostic, or predictive test or a 
        medical or surgical procedure.'';
            (2) by redesignating subparagraphs (F) and (G) as 
        subparagraphs (G) and (H), respectively; and
            (3) by inserting after subparagraph (E) the following:
            ``(F) the term `genetic diagnostic, prognostic, or 
        predictive test' means any test, designed to detect disease, to 
        predict the potential for a medical disorder, or to predict the 
        effectiveness of therapeutics, which uses either an ordered 
        listing of nucleotides comprising a portion of a human or human 
        pathogen genetic code or the proteins encoded by such 
        nucleotides.''.
    (b) Repeal.--Section 287(c)(3) of title 35, United States Code, is 
repealed.
    (c) Applicability.--Notwithstanding section 287(c)(4) of of title 
35, United States Code, the amendments made by subsection (a) shall not 
apply to any patent issued based on an application the earliest 
effective filing date of which is before the date of the enactment of 
this Act.

SEC. 4. PUBLIC DISCLOSURE OF GENETIC SEQUENCE INFORMATION IN FEDERAL 
              AND FEDERALLY ASSISTED PATENTS.

    (a) Statement of Policy and Objectives.--Section 200 of title 35, 
United States Code, is amended by inserting ``to promote the 
informational value of patents;'' after ``United States industry and 
labor;''.
    (b) Disposition of Rights.--Section 202(c) of title 35, United 
States Code, is amended by adding at the end the following new 
paragraph:
            ``(9) That the contractor, not later than 30 days after the 
        date on which the contractor files an application for a patent 
        on a subject invention which involves a patent for, or a patent 
        for use of, genetic sequence information (as defined in section 
        271(j)(2)(B)), make that information public. This paragraph 
        applies in lieu of any provision of section 122.''.
    (c) Confidentiality.--Section 205 of title 35, United States Code, 
is amended by adding at the end the following new sentence: ``In any 
case, any Federal agency filing an application for patent on genetic 
sequence information (as defined in section 271(j)(2)(B)) shall 
(subject to section 181) disclose that information to the public not 
later than 30 days after filing the application. This paragraph applies 
in lieu of any provision of section 122.''.
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