I
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 non-
infringing uses of patents on genetic sequence informa-
tion for purposes of research and genetic diagnostic test-
ing, and to require public disclosure of such information
in certain patent applications.
Be it enacted by the Senate and House of Representa-
tives 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 indi-
vidual 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 pat-
ent 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, man-
ufacture, or composition of matter or improvement
thereof; and
‘‘(E) the term ‘research’ means a systematic in-
vestigation, 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 per-
formance of a genetic diagnostic, prognostic, or pre-
dictive 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 fol-
lowing:
‘‘(F) the term ‘genetic diagnostic, prognostic, or
predictive test’ means any test, designed to detect
disease, to predict the potential for a medical dis-
order, 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 nucleo-
tides.’’.
(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 amend-
ments made by subsection (a) shall not apply to any pat-
ent 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 IN-
FORMATION IN FEDERAL AND FEDERALLY
ASSISTED PATENTS.
(a) STATEMENT OF POLICY AND OBJECTIVES.—Sec-
tion 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 infor-
mation (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 para-
graph applies in lieu of any provision of section 122.’’.
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