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In preparation for the talk: In preparation for the talk: ACLU-produced video segment: ACLU-produced video segment: http://www.youtube.com/watch?v=6h6X46-qz14 Excerpt from documentary: Excerpt from documentary: http://www.youtube.com/watch?v=wffdT0T3wgw Disclaimer: The following guest presentation is not intended to present Disclaimer: The following guest presentation is not intended to present an official position of BIO, any of its members, or the USPTO. While BIO an official position of BIO, any of its members, or the USPTO. While BIO has appeared as an has appeared as an amicus curiae amicus curiae in this case opposing plaintiffs’ in this case opposing plaintiffs’ contentions, any views expressed in this presentation, and any errors or contentions, any views expressed in this presentation, and any errors or omissions, are the presenter’s alone. No party to this case is a member omissions, are the presenter’s alone. No party to this case is a member or affiliate of BIO. or affiliate of BIO. Before the talk, take 10 minutes to watch the following two video clips.

In preparation for the talk: ACLU-produced video segment: ACLU-produced video segment:

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In preparation for the talk:In preparation for the talk:

ACLU-produced video segment:ACLU-produced video segment: http://www.youtube.com/watch?v=6h6X46-qz14

Excerpt from documentary:Excerpt from documentary: http://www.youtube.com/watch?v=wffdT0T3wgw

Disclaimer: The following guest presentation is not intended to present an Disclaimer: The following guest presentation is not intended to present an official position of BIO, any of its members, or the USPTO. While BIO has official position of BIO, any of its members, or the USPTO. While BIO has appeared as an appeared as an amicus curiaeamicus curiae in this case opposing plaintiffs’ contentions, in this case opposing plaintiffs’ contentions, any views expressed in this presentation, and any errors or omissions, are any views expressed in this presentation, and any errors or omissions, are the presenter’s alone. No party to this case is a member or affiliate of BIO.the presenter’s alone. No party to this case is a member or affiliate of BIO.

Before the talk, take 10 minutes to watch the following two video clips.

Perspectives on “Gene Perspectives on “Gene Patents:”Patents:”

Association for Molecular Association for Molecular Pathology et al. v. USPTO et Pathology et al. v. USPTO et

al.:al.:

Guest Presentation at the Guest Presentation at the

June 1, 2010 June 1, 2010 Biotechnology/Chemical/ Biotechnology/Chemical/ Pharmaceutical Customer Pharmaceutical Customer

Partnership Meeting,Partnership Meeting,

United States Patent andUnited States Patent andTrademark OfficeTrademark Office

Hans Sauer,Hans Sauer,

Biotechnology Industry Biotechnology Industry OrganizationOrganization

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Association for Molecular Pathology, et Association for Molecular Pathology, et al. v. United States Patent and al. v. United States Patent and

Trademark Office, et al.Trademark Office, et al. May 12, 2009; declaratory judgment action in Federal May 12, 2009; declaratory judgment action in Federal

District Court (SDNY); challenges patent claims directed District Court (SDNY); challenges patent claims directed towards the BRCA1 and BRCA2 genes.towards the BRCA1 and BRCA2 genes.

Plaintiffs:Plaintiffs: Association for Molecular Pathology;Association for Molecular Pathology; American College of Medical Genetics;American College of Medical Genetics; American Society for Clinical Pathology;American Society for Clinical Pathology; College of American PathologistsCollege of American Pathologists Laboratory clinicians and genetic counselorsLaboratory clinicians and genetic counselors Women’s health activist groupsWomen’s health activist groups Individual women plaintiffsIndividual women plaintiffs

Represented by ACLU and PubPat FoundationRepresented by ACLU and PubPat Foundation Defendants:Defendants:

USPTO;USPTO; Directors of University of Utah Res. Found.Directors of University of Utah Res. Found. Myriad Genetics Inc.Myriad Genetics Inc.

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AMP, et al. v. USPTO, et al.AMP, et al. v. USPTO, et al.The challenged claims:The challenged claims:

Patent claims alleged to cover natural human genes: Patent claims alleged to cover natural human genes: e.g. U.S. 5,747,282e.g. U.S. 5,747,282

1. An isolated DNA coding for a BRCA1 polypeptide, said polypeptide 1. An isolated DNA coding for a BRCA1 polypeptide, said polypeptide having the amino acid sequence set forth in SEQ ID NO:2. having the amino acid sequence set forth in SEQ ID NO:2. 2. The isolated DNA of claim 1, wherein said DNA has the nucleotide 2. The isolated DNA of claim 1, wherein said DNA has the nucleotide sequence set forth in SEQ ID NO:1.sequence set forth in SEQ ID NO:1.

Patent claims alleged to cover natural human genes Patent claims alleged to cover natural human genes with natural mutations: e.g. U.S. 5,693,473with natural mutations: e.g. U.S. 5,693,473

An isolated DNA comprising an altered BRCA1 DNA having at least An isolated DNA comprising an altered BRCA1 DNA having at least one of the alterations set forth in Tables 12A, 14, 18 or 19 with the one of the alterations set forth in Tables 12A, 14, 18 or 19 with the proviso that the alteration is not a deletion of four nucleotides proviso that the alteration is not a deletion of four nucleotides corresponding to base numbers 4184-4187 in SEQ. ID. NO:1. corresponding to base numbers 4184-4187 in SEQ. ID. NO:1.

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AMP, et al. v. USPTO, et al.AMP, et al. v. USPTO, et al.The challenged claims (2)The challenged claims (2)

Patent claims alleged to cover any method “of looking for Patent claims alleged to cover any method “of looking for mutations of natural human genes:” e.g. U.S. 5,709,999;mutations of natural human genes:” e.g. U.S. 5,709,999;

1. A method for detecting a germline alteration in a BRCA1 gene, said alteration 1. A method for detecting a germline alteration in a BRCA1 gene, said alteration selected from the group consisting of the alterations set forth in Tables 12A, 14, selected from the group consisting of the alterations set forth in Tables 12A, 14, 18 or 19 in a human which comprises analyzing a sequence of a BRCA1 gene or 18 or 19 in a human which comprises analyzing a sequence of a BRCA1 gene or BRCA1 RNA from a human sample or analyzing a sequence of BRCA1 cDNA BRCA1 RNA from a human sample or analyzing a sequence of BRCA1 cDNA made from mRNA from said human sample with the proviso that said germline made from mRNA from said human sample with the proviso that said germline alteration is not a deletion of 4 nucleotides corresponding to base numbers alteration is not a deletion of 4 nucleotides corresponding to base numbers 4184-4187 of SEQ ID NO:1. 4184-4187 of SEQ ID NO:1.

Patent claims alleged to cover “the thought that two genes are Patent claims alleged to cover “the thought that two genes are different, including the thought that [differences correlate with different, including the thought that [differences correlate with cancer susceptibility];“ e.g. U.S. 5,753,441;cancer susceptibility];“ e.g. U.S. 5,753,441;

1. A method for screening germline of a human subject for an alteration of a 1. A method for screening germline of a human subject for an alteration of a BRCA1 gene which comprises comparing germline sequence of a BRCA1 gene BRCA1 gene which comprises comparing germline sequence of a BRCA1 gene or BRCA1 RNA from a tissue sample from said subject or a sequence of BRCA1 or BRCA1 RNA from a tissue sample from said subject or a sequence of BRCA1 cDNA made from mRNA from said sample with germline sequences of wild-type cDNA made from mRNA from said sample with germline sequences of wild-type BRCA1 gene, wild-type BRCA1 RNA or wild-type BRCA1 cDNA, wherein a BRCA1 gene, wild-type BRCA1 RNA or wild-type BRCA1 cDNA, wherein a difference in the sequence of the BRCA1 gene, BRCA1 RNA or BRCA1 cDNA of difference in the sequence of the BRCA1 gene, BRCA1 RNA or BRCA1 cDNA of the subject from wild-type indicates an alteration in the BRCA1 gene in said the subject from wild-type indicates an alteration in the BRCA1 gene in said subject. subject. 5

AMP, et al. v. USPTO, et al.AMP, et al. v. USPTO, et al.Legal theoryLegal theory

Legal arguments: The challenged claims are supposedly:Legal arguments: The challenged claims are supposedly:

invalid under 35 U.S.C. 101;invalid under 35 U.S.C. 101; unconstitutional under the First Amendment;unconstitutional under the First Amendment; invalid under Article 1, Section 8, Clause 8 of the invalid under Article 1, Section 8, Clause 8 of the

ConstitutionConstitution

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AMP, et al. v. USPTO, et al.AMP, et al. v. USPTO, et al.Invalidity under the IP ClauseInvalidity under the IP Clause

Argument: the claims are invalid under Article 1, Section 8, Argument: the claims are invalid under Article 1, Section 8, Clause 8 of the ConstitutionClause 8 of the Constitution

The patent claims are said to impede rather than promote the The patent claims are said to impede rather than promote the progress of science: progress of science: Patents are not necessary to incentivize the identification and Patents are not necessary to incentivize the identification and

sequencing of genes;sequencing of genes; Patents are not necessary to incentivize physicians to conduct Patents are not necessary to incentivize physicians to conduct

genetic testing and counseling;genetic testing and counseling; Patents impede research, clinical development, and quality of Patents impede research, clinical development, and quality of

genetic testinggenetic testing 7

AMP, et al. v. USPTO, et al.AMP, et al. v. USPTO, et al.Unconstitutionality under the First Unconstitutionality under the First

AmendmentAmendment Argument: the claims are unconstitutional under the Argument: the claims are unconstitutional under the

First Amendment of the ConstitutionFirst Amendment of the Constitution

Congress shall make no law respecting an establishment of Congress shall make no law respecting an establishment of religion, or prohibiting the free exercise thereof; or abridging religion, or prohibiting the free exercise thereof; or abridging the freedom of speech, or of the press; or the right of the the freedom of speech, or of the press; or the right of the people peaceably to assemble, and to petition the Government people peaceably to assemble, and to petition the Government for a redress of grievances. for a redress of grievances.

Analogy to copyright law: an idea is not copyrightable; but its Analogy to copyright law: an idea is not copyrightable; but its expression is. Believed to have First Amendment roots.expression is. Believed to have First Amendment roots.

First Amendment prohibits Government from limiting human First Amendment prohibits Government from limiting human thought and available knowledge. The patents are said to do thought and available knowledge. The patents are said to do both, and are therefore unconstitutional.both, and are therefore unconstitutional.

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AMP, et al. v. USPTO, et al.AMP, et al. v. USPTO, et al.Unconstitutionality under the First Unconstitutionality under the First

Amendment (2)Amendment (2) For First Amendment purposes, claims divided into:For First Amendment purposes, claims divided into:

““Claims for reaching conclusions about the genes” (process Claims for reaching conclusions about the genes” (process claims)claims)

““Claims to the genes themselves” (composition of matter claims)Claims to the genes themselves” (composition of matter claims)

The The process claims process claims are said to preempt the mental act of are said to preempt the mental act of comparing e.g. mutated with wild-type sequences and concluding comparing e.g. mutated with wild-type sequences and concluding e.g. that the carrier is cancer-susceptible. These claims are said to: e.g. that the carrier is cancer-susceptible. These claims are said to: preempt human thought;preempt human thought; violate a right to scientific inquiry believed to reside in the First Amendmentviolate a right to scientific inquiry believed to reside in the First Amendment

The The claims to the polynucleotides claims to the polynucleotides themselves are said to cover themselves are said to cover genetic information. It is argued that the essence of a gene is the genetic information. It is argued that the essence of a gene is the information it contains, and the composition of matter claims information it contains, and the composition of matter claims preempt all use of that information; amounting to a monopoly on preempt all use of that information; amounting to a monopoly on pure genetic information (Granting patents = censoring pure genetic information (Granting patents = censoring newspapers or banning books).newspapers or banning books). 99

AMP, et al. v. USPTO, et al.AMP, et al. v. USPTO, et al.Invalidity under 35 U.S.C. 101Invalidity under 35 U.S.C. 101

Method claims alleged to violate prohibition against abstract ideas or Method claims alleged to violate prohibition against abstract ideas or laws of nature;laws of nature;

Nucleotide claims said to violate prohibition against patenting products Nucleotide claims said to violate prohibition against patenting products of natureof nature

Examples of challenged method claims: U.S. 6,033,857Examples of challenged method claims: U.S. 6,033,857 1. 1. A method for identifying a mutant BRCA2 nucleotide sequenceA method for identifying a mutant BRCA2 nucleotide sequence in a in a

suspected mutant BRCA2 allele suspected mutant BRCA2 allele which comprises comparing the which comprises comparing the nucleotide sequencenucleotide sequence of the suspected mutant BRCA2 allele of the suspected mutant BRCA2 allele with the with the wild-type BRCA2 nucleotide sequencewild-type BRCA2 nucleotide sequence, wherein a difference between , wherein a difference between the suspected mutant and the wild-type sequences identifies a mutant the suspected mutant and the wild-type sequences identifies a mutant BRCA2 nucleotide sequence.BRCA2 nucleotide sequence.

2. 2. A method for diagnosing a predisposition for breast cancerA method for diagnosing a predisposition for breast cancer in a in a human subject human subject which comprises comparing the germline sequencewhich comprises comparing the germline sequence of of the BRCA2 gene or the sequence of its mRNA in a tissue sample from the BRCA2 gene or the sequence of its mRNA in a tissue sample from said subject said subject with the germline sequence of the wild-typewith the germline sequence of the wild-type BRCA2 gene or BRCA2 gene or the sequence of its mRNA, wherein an alteration in the germline the sequence of its mRNA, wherein an alteration in the germline sequence of the BRCA2 gene or the sequence of its mRNA of the subject sequence of the BRCA2 gene or the sequence of its mRNA of the subject indicates a predisposition to said cancer.indicates a predisposition to said cancer.

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AMP, et al. v. USPTO, et al.AMP, et al. v. USPTO, et al.Invalidity under 35 U.S.C. 101Invalidity under 35 U.S.C. 101

Examples of challenged nucleotide claims: Examples of challenged nucleotide claims: U.S. 5,747,282U.S. 5,747,282 2. [An isolated DNA coding for a BRCA1 polypeptide,] wherein 2. [An isolated DNA coding for a BRCA1 polypeptide,] wherein

said DNA has the nucleotide sequence set forth in SEQ ID NO:1.said DNA has the nucleotide sequence set forth in SEQ ID NO:1. The claim is said to be to a product of nature:The claim is said to be to a product of nature:

Claimed sequence is identical to natural sequence;Claimed sequence is identical to natural sequence; Encodes the same protein;Encodes the same protein; Mirrors the naturally-occurring mRNAMirrors the naturally-occurring mRNA Serves no new function and has no different quality from the Serves no new function and has no different quality from the

natural sequencenatural sequence Isolating and/or purifying is not sufficient to confer patent-Isolating and/or purifying is not sufficient to confer patent-

eligibility on a natural product;eligibility on a natural product;

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Isolation and purification from natureIsolation and purification from nature

““Products of nature” would today typically be rejected under 35 U.S.C. Products of nature” would today typically be rejected under 35 U.S.C. 101.101.

Caselaw dealing with “products of nature” is quite old and the legal Caselaw dealing with “products of nature” is quite old and the legal foundation of the prohibition is unclear and unexplained. The issue foundation of the prohibition is unclear and unexplained. The issue sometimes seems to be novelty, sometimes obviousness, rarely patent-sometimes seems to be novelty, sometimes obviousness, rarely patent-eligibility.eligibility.

American Wood-Paper Co. v. Fibre Disintegrating Co., American Wood-Paper Co. v. Fibre Disintegrating Co., 90 U.S. 566 (1874) 90 U.S. 566 (1874) (pure cellulose pulp preparation prepared by novel chemical process held (pure cellulose pulp preparation prepared by novel chemical process held not novel over prior art cellulose pulp preparations made by old process);not novel over prior art cellulose pulp preparations made by old process);

Cochrane v. BASFCochrane v. BASF, 111 U.S. 293 (1884)(claimed “artificial alizarine” , 111 U.S. 293 (1884)(claimed “artificial alizarine” prepared by new chemical process not novel over prior art impure prepared by new chemical process not novel over prior art impure alizarine extracts from madder root);alizarine extracts from madder root);

American Fruit Growers v. Brogdex Co., American Fruit Growers v. Brogdex Co., 283 U.S. 1 (1931)(Borax-treated 283 U.S. 1 (1931)(Borax-treated citrus fruit is insufficiently changed from natural fruit, and not a citrus fruit is insufficiently changed from natural fruit, and not a manufacture within the meaning of the Patent Act);manufacture within the meaning of the Patent Act);

Funk Bros. Seed Co. v. Kalo Inoculant Co., Funk Bros. Seed Co. v. Kalo Inoculant Co., 333 U.S. 127 (1948)(claimed 333 U.S. 127 (1948)(claimed inoculate of mutually non-inhibitive root-nodule bacteria held not inoculate of mutually non-inhibitive root-nodule bacteria held not inventive over preexisting state of the art).inventive over preexisting state of the art).

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Isolation and purification from natureIsolation and purification from nature

Much of the caselaw on isolation and purification deals with distinguishing Much of the caselaw on isolation and purification deals with distinguishing the invention over the prior art – not with determining whether the purified the invention over the prior art – not with determining whether the purified product is patent-eligible when the natural precursor is not in the prior art.product is patent-eligible when the natural precursor is not in the prior art.

When the question was unambiguously one of patent-eligibility, the Supreme When the question was unambiguously one of patent-eligibility, the Supreme Court has identified human intervention as the touchstone. Court has identified human intervention as the touchstone. Diamond v. Diamond v. ChakrabartyChakrabarty; (“the invention is not nature’s handiwork, but his own”), ; (“the invention is not nature’s handiwork, but his own”), accord accord J.E.M. Ag-SupplyJ.E.M. Ag-Supply

Parke-Davis & Co. v. H.K. Mulford Co., Parke-Davis & Co. v. H.K. Mulford Co., 189 F. 95 (C.C.N.Y. 1911). (Purified 189 F. 95 (C.C.N.Y. 1911). (Purified adrenaline so superior to previous adrenal gland extracts so as to be adrenaline so superior to previous adrenal gland extracts so as to be different not just in degree, but in kind);different not just in degree, but in kind);

Merck & Co. v. Olin Mathieson Chemical Corp., Merck & Co. v. Olin Mathieson Chemical Corp., 253 F.2d 156 (4253 F.2d 156 (4thth Cir. 1958). Cir. 1958). Concept supported by caselaw: the invention must have been transformed Concept supported by caselaw: the invention must have been transformed

through human intervention from the natural thing into something that is through human intervention from the natural thing into something that is qualitatively different, new, and man-made.qualitatively different, new, and man-made.

Never been addressed for “isolated and purified DNA.”Never been addressed for “isolated and purified DNA.”

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AMP, et al. v. USPTO, et al.AMP, et al. v. USPTO, et al.Policy argumentsPolicy arguments

Gene patents:Gene patents: Are not necessary to incentivize gene discoveryAre not necessary to incentivize gene discovery Are not necessary to incentivize commercialization of gene testsAre not necessary to incentivize commercialization of gene tests Lead to fewer genetic test providersLead to fewer genetic test providers Cause inflated prices for genetic testsCause inflated prices for genetic tests Restrict patient access to genetic testsRestrict patient access to genetic tests Lead to lower quality of genetic tests and other genetic Lead to lower quality of genetic tests and other genetic

technologytechnology Stifle basic or applied research into new or improved genetic Stifle basic or applied research into new or improved genetic

technologiestechnologies Create infringement liability for women who donate cancer Create infringement liability for women who donate cancer

samples for researchsamples for research Prevent patients from getting a second opinionPrevent patients from getting a second opinion

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AMP, et al. v. USPTO, et al.AMP, et al. v. USPTO, et al.Public supportPublic support

Public support through many amicus briefs, press releases or Public support through many amicus briefs, press releases or supporting statements:supporting statements: American Medical Association, American College of American Medical Association, American College of

Obstetricians and Gynecologists, other medical associations;Obstetricians and Gynecologists, other medical associations; March of Dimes, NORD, other patient groups; Greenpeace, March of Dimes, NORD, other patient groups; Greenpeace,

Indigenous Peoples Council on Biocolonialism, others;Indigenous Peoples Council on Biocolonialism, others; United Methodist Church, Southern Baptist Convention;United Methodist Church, Southern Baptist Convention; Gender / minority-focused civil rights groups.Gender / minority-focused civil rights groups.

Amicus briefs opposing plaintiffs’ position:Amicus briefs opposing plaintiffs’ position: BIO ; Boston Patent Law Association; Rosetta Genomics; BIO ; Boston Patent Law Association; Rosetta Genomics;

George Mason University; BayBio; Celera Corp., Genetic George Mason University; BayBio; Celera Corp., Genetic Alliance; Coalition for 21st Century Medicine; Genomic Health, Alliance; Coalition for 21st Century Medicine; Genomic Health, Inc.; Qiagen, N.V.; Target Discovery, Inc.; XDx, Inc.; Kenneth Inc.; Qiagen, N.V.; Target Discovery, Inc.; XDx, Inc.; Kenneth Chahine,; Kevin E. Noonan.Chahine,; Kevin E. Noonan.

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AMP, et al. v. USPTO, et al.AMP, et al. v. USPTO, et al.Status and contextStatus and context

Status of the case:Status of the case: Motions to dismiss denied Nov. 2, 2009; summary Motions to dismiss denied Nov. 2, 2009; summary

judgment motion heard Feb. 2.; Opinion issued Mar. judgment motion heard Feb. 2.; Opinion issued Mar. 29.; Judgment entered Apr. 19.29.; Judgment entered Apr. 19.

Discussion of the opinionDiscussion of the opinion Context of the caseContext of the case

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Hans SauerDeputy General Counsel,

BIO1201 Maryland Avenue,

S.W.Washington, D.C. 20024

U.S.A.

Tel. (x1)-202-962-6695Fax. (x1)-202-488-0650

[email protected]

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