Association For Molecular Pathology et al v. United States Patent and Trademark Office et al

Filing 197

BRIEF re: 195 MOTION for Leave to File Brief Amici Curiae. [Proposed] Brief for Amici Curiae. Document filed by Celera Corporation, Genomic Health, Inc., QIAGEN, N.V., BayBio, The Coalition for 21st Century Medicine, Target Discovery, Inc., XDx, Inc.. (Attachments: # 1 Declaration of William G. Gaede, III, # 2 Exhibit 1, # 3 Exhibit 2, # 4 Exhibit 3, # 5 Exhibit 4, # 6 Exhibit 5, # 7 Exhibit 6, # 8 Exhibit 7, # 9 Exhibit 8, # 10 Exhibit 9, # 11 Exhibit 10, # 12 Exhibit 11, # 13 Exhibit 12, # 14 Exhibit 13, # 15 Exhibit 14, # 16 Exhibit 15, # 17 Exhibit 16, # 18 Exhibit 17, # 19 Exhibit 18, # 20 Exhibit 19, # 21 Exhibit 20, # 22 Exhibit 21)(Huttenlocher, Michael)

Association For Molecular Pathology et al v. United States Patent and Trademark Office et al

Doc. 197 Att. 20

EXHIBIT 19

Dockets.Justia.com

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 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. 1 Be it enacted by the Senate and House of Representa-

2 tives of the United States of America in Congress assembled, 3 4
SECTION 1. SHORT TITLE.

This Act may be cited as the ``Genomic Research and

5 Diagnostic Accessibility Act of 2002''.

2 1 2 3
SEC. 2. EXEMPTION FROM INFRINGEMENT FOR RESEARCH ON GENETIC SEQUENCE INFORMATION.

Section 271 of title 35, United States Code, is

4 amended by adding at the end thereof the following new 5 subsection: 6 ``(j) USE
OF

GENETIC SEQUENCE INFORMATION.--

7 (1) It shall not be an act of infringement for any indi8 vidual or entity to use any patent for or patented use of 9 genetic sequence information for purposes of research. 10 This paragraph shall not apply to any individual or entity 11 that is directly engaged in the commercial manufacture, 12 commercial sale, or commercial offer for sale of a drug, 13 medical device, process, or other product using such pat14 ent for or patented use of genetic sequence information. 15 16 17 18 19 20 21 22 23 24 ``(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));

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3 1 2 3 4 5 6 7 8 9 10 ``(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,

11 United States Code, is amended-- 12 13 14 15 16 17 18 19 20 21 22 23 24 25 (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

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4 1 2 3 4 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

5 States Code, is repealed. 6 (c) APPLICABILITY.--Notwithstanding section

7 287(c)(4) of of title 35, United States Code, the amend8 ments made by subsection (a) shall not apply to any pat9 ent issued based on an application the earliest effective 10 filing date of which is before the date of the enactment 11 of this Act. 12 13 14 15
SEC. 4. PUBLIC DISCLOSURE OF GENETIC SEQUENCE INFORMATION IN FEDERAL AND FEDERALLY ASSISTED PATENTS.

(a) STATEMENT

OF

POLICY

AND

OBJECTIVES.--Sec-

16 tion 200 of title 35, United States Code, is amended by 17 inserting ``to promote the informational value of patents;'' 18 after ``United States industry and labor;''. 19 (b) DISPOSITION
OF

RIGHTS.--Section 202(c) of title

20 35, United States Code, is amended by adding at the end 21 the following new paragraph: 22 23 24 25 ``(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

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5 1 2 3 4 5 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,

6 United States Code, is amended by adding at the end the 7 following new sentence: ``In any case, any Federal agency 8 filing an application for patent on genetic sequence infor9 mation (as defined in section 271(j)(2)(B)) shall (subject 10 to section 181) disclose that information to the public not 11 later than 30 days after filing the application. This para12 graph applies in lieu of any provision of section 122.''.

Æ

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