Diamond v. Chakrabarty

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(processes)

Diamond v. Chakrabarty⁴³

: Diamond v.

Chakrabarty

1972 Ananda M.

Chakrabarty Pseudomonas

DNA

plasmid DNA

43 Diamond v. Chakrabarty, 447 U.S. 303 (1980)

•‧

Diamond v. Chakrabarty

Diamond v. Chakrabarty (living things)

44 Funk Bros. Seed Co. v. Kalo Inoculant Co. ⁴⁵

Kewanee Oil Co. v. Bicron Corp. :

44 Diamond v. Chakrabarty, 447 U.S. 303, 306-09 (1980) (the Supreme Court "granted certiorari to determine whether a live, human-made" bacterium constituted patentable subject matter after the PTO commissioner appealed the Court of Customs and Patent Appeals' decision to allow the issue of a patent on a living thing).

45 Funk Bros. Seed Co. v. Kalo Inoculant Co. 333 U.S. 127, 130 (1948)

46 discoveries that are "manifestations of laws of nature, free to all men, reserved exclusively to none"

are patent ineligible.

As the Court later stated in Diamond v. Chakrabarty, this non-patentable matter includes "a new mineral discovered in the earth or a new plant found in the wild . . . . Likewise, Einstein could not patent his celebrated law that E=mc2; nor could Newton have patented the law of gravity." Chakrabarty, 447 U.S. at 309.

•‧

exercised in the hope that [t]he productive effort thereby fostered will have a positive effect on society through the introduction of new products and processes of manufacture into the economy, and the emanations by way of increased employment and better lives. )⁴⁷

101 ⁴⁸

(microorganism) (composition of matter)

(manufacture)

(manufacture) American Fruit Growers, Inc.

v. Brogdex Co⁴⁹ :

(forms) (qualities) (properties)

(combinations) ⁵⁰ Shell Development Co. v.

4777 U.S. 303 (1980) at 307 (quoting Kewanee Oil Co. v. Bicron Corp., 416 U.S. 470, 480 (1974)). It is relevant to note that the Court began its analysis by articulating the purpose of patents--providing incentives for innovation. Rather than beginning the discussion with an interpretation of the statute, the Court chose to highlight the legislative intent of patents.

48 35 U.S.C. 101 Inventions patentable. Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.

49 American Fruit Growers, inc. V. Brogdex Co., 283 U.S. at 11, 51 S.Ct. 328.

50 Chakrabarty, 447 U.S. at 308 (quoting American Fruit Growers, 238 U.S. at 11). The Court applied the dictionary definition to the term "manufacture." Define "manufacture" as "the production of articles for use . . . by giving to these materials new forms, qualities, properties, or combinations, whether by handlabor or by machinery."

•‧

(forms) (qualities) (properties) (combinations)?

Dr. Chakrabarty Funk Bros.

Dr. Chakrabarty

Chakrabarty

101 manufacture

composition of matter

51 Shell Development Co. v. Watson, 149 F. Supp. 279, 280 (D.D.C. 1957).

52 Chakrabarty, 447 U.S. at 308 (quoting Shell Development Co., 149 F. Supp. at 280 (citing 1 ANTHONY DELLER, WALKER ONPATENTS § 14, at 55 (1st ed. 1937))). (“all compositions of two or more substances and . . . all composite articles,whether they be the results of chemical union, or of mechanical mixture, or whether they be gases, fluids, powders or solids. It is important to note that the Court applied the broad definition used by the United States District Court for the District of Columbia rather than forming its own definition. The Court could have looked to other common uses that were less expansive instead of choosing to incorporate such a sweeping definition. This indicates the Court's willingness to broaden the scope of patentable subject matter. See id.

53 Schering Corporation v. Gilbert, 153 F.2d 428 (2d Cir. 1946).

•‧

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101

manufacture composition of matter

law of

nature physical phenomenon abstract idea

Chakrabarty

1930 1970

101

5:4 101

Chakrabarty

2010 Bilski 2013 Myriad 101

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Chakrabarty

Chakrabarty Chakrabarty

Dr.

Chakrabarty

2010 Bilski 2013 Myriad

101

•‧

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N a tio na

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: Myriad

BRCA1 BRCA2

DNA

BRCA BRCA

BRCA1 BRCA2

BRCA1

•‧

(United States Department of Defense)

1990 2008

1990 Mary-Claire King

17 ⁵⁴

OncorMed ⁵⁵

(University of Utah's Centre for Genetic Epidemiology) Marc Skolnick

54 Hall JM, Lee MK, Newman B, Morrow JE, Anderson LA, Huey B, King MC. Linkage of early-onset familial breast cancer to chromosome 17q21. Science. 1990 Dec 21;250(4988):1684-9.

55 Marshall E. The battle over BRCA1 goes to court; BRCA2 may be next. Science. 1997 Dec 12;278(5345):1874.

56 1847

•‧

1970 (Mormon families)

Skolnick

1991 Myriad (Eli Lilly and Co.)

(NIH) 1993

Myriad 1994 10 7

58 Williams-Jones B. History of a gene patent: tracing the development and application of commercial BRCA testing. Health Law J 2002;10:123–146.

59 Gold ER and Carbone J. Myriad Genetics: In the eye of the policy storm. Genet Med. 2010 Apr;12(4 Suppl):S39-70.

•‧

BRCA1 ⁶⁰ Myriad 8 12

Myriad Myriad

(United States Department of Human Health and Services)

Myriad Myriad

US 5,693,47323 BRCA1 47

Myriad ⁶¹ BRCA1 1995

6 7 Myriad BRCA1 BRCA1

1998 1 20 1998 5 5

Myriad BRCA1

Myriad Dr. King OncorMed ⁶²

1995 12 21 Myriad BRCA2

Stratton BRCA2 ⁶³

60 Miki Y, Swensen J, Shattuck-Eidens D, Futreal PA, Harshman K, Tavtigian S, Liu Q, Cochran C, Bennett LM, Ding W, et al. A strong candidate for the breast and ovarian cancer susceptibility gene BRCA1. Science. 1994 Oct 7;266(5182):66-71.

61 US 5,709,999; US 5,747,282; US 5,710,001; US 5,753,441; and US 6,162,89723

62 3 Myriad filed suit against Oncormed Inc. in 1997 and again in 1998, Myriad Genetics v.

Oncormed, Nos. 2:97-cv-922, 2:98-cv-35 (D. Utah), and the University of Pennsylvania in 1998, Myriad Genetics v. Univ. of Pa., No. 2:98-cv-829 (D. Utah). Both lawsuits were later dismissed without prejudice after each defendant agreed to discontinue all allegedly infringing activity.

63 Wooster R, Bignell G, Lancaster J, Swift S, Seal S, Mangion J, Collins N, Gregory S, Gumbs C, Micklem G. Identification of the breast cancer susceptibility gene BRCA2. Nature. 1995 Dec 21-28;378(6559):789-92.

•‧

Stratton Myriad

Myriad BRCA1/2 DNA (isolated

DNA)

BRCA1 and/or BRCA2 Myriad 1997 BRCA1

BRCA2 Myriad

Myriad (European Patent Office, EPO)

(method) 699,754 (method for diagnosing a predispodition for

64 Myriad website: http://www.Myriad.com (Last visited on 2016/01/15)

65 BRCA 3241736 3455228 3399539

BRCA1 BRCA2 BRCA1

•‧

breast and ovarian cancer) (gene) 705,902 (17q-linked breast and ovarian cancer susceptibility gene) 705,903 (in vivo mutation and polymorphism in the 17q-linked breast and ovarian cancer susceptibility gene)

Myriad

EPC 53 c

EPO 699,754

EPO 7

Myriad 2008 11 17 EPO

25 7

BRAC1/2 3,120 93,600 (

) 460

13,800 BRAC1/2 1,500 ⁶⁸

Myriad 47 326.5

66 BRCA1 115 2009 2 20

67 BRCA1

173-74 (2010)

68 http://www.nature.com/news/2008/081202/full/456556a.html (Last visited on 2013/10/9)

•‧

2009 Myriad ⁶⁹

BRCA Myriad 830

4.5 2012 1200 4.96

4-1 Myriad

1980

1991 - BRCA1

1994-1995 Myriad BRCA

1996 Myriad BRACAnalysis

1997-1998 BRCA 20

1998-1999 Myriad BRCA

: Myriad (2016/01)

(ANGELINA JOLIE) 2013 5 BRAC1

69 http://www.google.com/finance?q=NASDAQ%3AMYGN (Last visited on 2011/11/24)

•‧

Myriad (Myriad Genetics & Laboratories Inc.)

BRCA1/2 101

eligibility

30 (NASDAQ stock

market) Myriad (MYGN) 9.2% 24.9

22.6 Myriad BRCA1/2

2008 Myriad BRCA

Myriad ⁷⁰

2009 5 12 (ACLU)

Myriad BRCA1

BRCA2 7

70 Myriad (European Patent Office, EPO) (method)

699,754 (method for diagnosing a predispodition for breast and ovarian cancer)

(gene) 705,902 (17q-linked breast and ovarian cancer susceptibility gene) 705,903 (in vivo mutation and polymorphism in the 17q-linked breast and ovarian cancer susceptibility

gene) Myriad EPC 53 c

EPO 699,754

EPO

7 Myriad 2008 11 17 EPO

25 7

•‧

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N a tio na

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2009 5 12 American Civil Liberties Union, ACLU

(Public Patent Foundation) BRCA1

BRCA2 Myriad Genetic (University of

Utah Research Foundation)

(First Amendment) (products of nature)

71 (Co-plaintiffs)

15,000

2010 3 29

BRCA1 BRCA (Invalid)

7 15

Myriad 2011 4 Myriad

2011 7 29

DNA Myriad BRCA DNA

71 Association for Molecular Pathology, et al. v. USPTO, et al., 702 F. Supp. 2d 181 (S.D.N.Y. 2010)

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5 Myriad

2012 3 26

2012 8

8 16 3 DNA

Myriad

2012 11 ⁷³

2013 6 13 DNA

Myriad

DNA

72 Association for Molecular Pathology v. U.S. Patent and Trademark Office, 653 F.3d 1329 (Fed. Cir.

2011).

73 Association for Molecular Pathology, et al., v. Myriad Genetics, Inc., et al., 132 S. Ct. 1794(2012).

•‧

2009 5 12 American Civil Liberties Union, ACLU

(Public Patent Foundation) BRCA1

BRCA2 Myriad Genetic (University of

Utah Research Foundation)

74 75

(products of nature) 101 ⁷⁶ ⁷⁷

4-2 Myriad Case Claims-in-suit

Claims-in-suit

Patent Claims Contents

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

http://www.ait.org.tw/zh/the-bill-of-rights.html : 2013/9/30

75 The Fourteenth Amendment (Amendment XIV) to the United States Constitution was adopted on July 9, 1868, as one of the Reconstruction Amendments. The amendment addresses citizenship rights and equal protection of the laws, and was proposed in response to issues related to former slaves following the American Civil War.

76 35 USC § 101 - Inventions patentable. Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.

77 Article I, Section 8, Clause 8 of the United States Constitution. To promote the Progress of Science and useful Arts, by securing for limited Times to Authors and Inventors the exclusive Right to their respective Writings and Discoveries.

•‧

17Q-linked breast and ovarian cancer susceptibility gene (17Q

) Skolnick

08/483,554 1998 5 5 20

6 20

U. S. Patent 5,837,492

Claims 1, 6, and 7 DNA

Chromosome 13-linked breast cancer susceptibility gene (13

) Tavtigian

08/639,501 1998 11 17 30

3 U. S. Patent

5,693,473

Claim 1 DNA

Linked breast and ovarian cancer susceptibility

gene 1 DNA

BRCA1 DNA⁷⁸ U. S. Patent

5,709,999

Claim 1 BRCA1 DNA

Linked breast and ovarian cancer susceptibility gene (

) Shattuck-Eidens

08/483,553 1998 1 20

35 1

U. S. Patent 5,710,001

Claim 1 BRCA1 DNA

17q-linked breast and ovarian cancer susceptibility gene

U. S. Patent 5,753,441

Claim 1 mRNA

cDNA BRCA1

170-linked breast and ovarian cancer susceptibility gene

U. S. Patent 6,033,857

Claims 1 and 2 BRCA2

Chromosome 13-linked breast cancer susceptibility gene (13

) Tavtigian

09/044,946 2000 3 7 8

: (2014)

78 . 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 proviso that the alteration is not a deletion of four nucleotides corresponding to base numbers 4184-4187 in SEQ. ID. NO:1.

•‧

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N a tio na

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(Co-plaintiffs)

yriad Genetics

Myriad

Myriad (isolated) (purify)

(1)

(2)

(composition claims) (method, or process claims) 15

9 6 6

5 (comparing and analyzing) 1

•‧

國

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N a tio na

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(screening)

(Machine-or-Transformation Test)

9 DNA

DNA DNA

(patentable subject matter must be “markedly different” from a product of nature) 1931 American Fruit Growers, inc. v. Brogdex Co.

(process a new or distinctive form, quality or property)

Myriad DNA

Parke-Davis⁸⁰ Myriad Genetics

BRCA1 DNA

79 American Fruit Growers, inc. V. Brogdex Co., 283 U.S. at 11, 51 S.Ct. 328.

80 Parke Davis & Co. v. H.K. Mulford Co., 189 F. 95 (S.D.N.Y.1911).

•‧

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N a tio na

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DNA DNA

15 9

DNA DNA (markedly different

characteristics) DNA (unique

characteristics) (physical embodiment of information)

DNA DNA 9

DNA (directed to unpatentable products of nature)

101

6 machine ot transformation test

5 DNA BRCA

(directed only to...abstract mental

processes) 101

Myriad (seeks to patent a basic scientific principle) 101

2010 3 29

•‧

BRCA1 BRCA2 (Invalid)

2011 4 Myriad

(CAFC) 2011 7 29 2012 3 26

Mayo Collaborative Services v. Prometheus, Inc.⁸²

2012 8 16 5

81 The District Court, Sweet, J., held that:(1) patents for isolated DNA containing breast cancer susceptibility genes were invalid, and(2) patents for methods of analyzing gene sequences were invalid.

Ordered accordingly. 5,693,473, 5,709,999, 5,710,001, 5,747,282, 5,753,441, 5,837,492, 6,033,857.

Invalid.

82 Mayo Collaborative Services v. Prometheus, Inc., 566 U.S. ___, 132 S. Ct. 1289 (2012).

•‧

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N a tio na

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Lourie Moore DNA

Bryson

Myriad

DNA ⁸³

101

Myriad DNA

DNA

Myriad DNA 101

Myriad DNA

Myriad DNA DNA

DNA Myriad

83 Ass’n for Molecular Pathology v. United States Patent & Trademark Office, 653 F.3d 1329, 1334 (Fed. Cir. 2011).

•‧

國

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N a tio na

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DNA 101

DNA DNA

DNA (preempt) BRCA

Lourie DNA

DNA DNA

(characteristics) Lourie

DNA

Lourie 101

DNA

•‧

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Myriad DNA

DNA DNA DNA 46

DNA DNA

DNA

DNA DNA DNA

DNA

BRCA1 17

BRCA2 13

BRCA1 BRCA2 BRCA2

BRCA1 282 5 6

DNA BRCA

BRCA1 BRCA2

DNA DNA DNA

DNA

•‧

國

立立政治大

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•‧

N a tio na

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DNA

DNA DNA

DNA

DNA DNA

DNA

DNA Myriad

2012 8

3 DNA

•‧

DNA DNA (markedly

different ... from molecules thate exist in nature) DNA (DNA

molecules) DNA (covalently bonded) Myriad

DNA Lourie

29 2645 DNA 2005

40000 DNA 20% 2001

DNA 101

DNA

Moore Lourie DNA

84 (2013)

•‧

85 DNA cDNA

DNA ’282 2 7 ’492

7 cDNA

(laws-of-nature) cDNA

(cDNA sequences do not exist in nature) Myriad DNA

DNA(isolated DNA)

(settled expectations of the biotechnology industry)

DNA 101

Bryson ⁸⁷

(the same, structurally and functionally, in both the native gene and the isolated . . . gene)

(broad claims to genetic material present a significant obstacle to the next generation of innovation in genetic

85 Moore, J., concurring in part and concurring in the judgment

86 PATENT LAW — PATENTABLE SUBJECT MATTER — FEDERAL CIRCUIT INVALIDATES DIAGNOSTIC METHOD CLAIMS AS DRAWN TO “ABSTRACT MENTAL PROCESSES.” — Association for Molecular Pathology v. U.S. Patent & Trademark Office, 653 F.3d 1329 (Fed. Cir.

2011). HARVARD LAW REVIEW. Vol. 125:658

87 Bryson, J., concurring in part and dissenting in part

•‧

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N a tio na

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medicine — multiplex tests and whole-genome sequencing)

(the PTO lacks substantive rulemaking authority as to issues such as patentability)

Myriad

2013 6 13 ⁸⁸

101 DNA

(un-patentable Subject Matter) DNA(cDNA) (

DNA) Myriad Genetics

BRCA cDNA

BRCA1 BRCA2

88 Association for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. __, 133 S. Ct. 2107, 106 USPQ2d 1972 (2013)

•‧

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N a tio na

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Myriad BRCA1 BRCA2

DNA Myriad BRCA1 BRCA2

Myriad Myriad

Myriad BRCA

DNA (cDNA)

Myriad

Myriad 2013 6 13

Myriad

DNA

•‧

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N a tio na

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89 Myriad

90 BRCA 2015

20%

1948 : (the work of nature)

(the laws of nature)

89 (Broad Institute)

•‧

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N a tio na

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USPTO

87 ( ) 59 1 2 ( )

Myriad

WTO/TRIPs 31

87 2 1 BRCA

1/2 59 1 2

BRCA 1/2 ⁹¹

91 Myriad 13 2013 4

•‧

Myriad DNA (single primers)

(sets of primers) (kits that include primers

and instructions) cDNA

DNA ⁹²

2013 7 Myriad

(Utah District

92 2014 3 USPTO (Laws of Nature) (Nature Phenomena)

(Product of Nature) (Guidance For Determining Subject Matter Eligibility Of Claims Reciting Or Involving Laws of Nature, Natural Phenomena, & Natural Products)

Myriad Mayo Collaborative Services v. Prometheus

Laboratories, Inc., 566 U.S. __, 132 S. Ct. 1289, 101 USPQ2d 1961 (2012) Diamond v. Chakrabarty, 447 U.S. 303 (1980) Funk Brothers Seed Co. v. Kalo Inoculant Co., 333 U.S. 127, 131 (1948)

•‧

國

立立政治大

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•‧

N a tio na

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Court) 8

Gene By Gene Ltd. Myriad Genetics

Dnatraits 995 BRCA1 BRCA2

BRCA1 BRCA2 ⁹³

Ambry Genetics⁹⁴ Counsyl⁹⁵ GeneDx Invitae LabCorp Pathway Genomics Quest Laboratories

University of Utah Research Foundation( )

Trustees of the University of Pennsylvania( )

93 Myriad Genetics Gene By Gene

2013 7

94 University of Utah Research Foundation, et al., v. Ambry Genetics Corporation, United States District for the District of Utah, Case No. 2:13-cv-00640-RJS.

95 Counsyl Inc. v. The University of Utah Research Foundation, et al., case number 2:14-cv-00150

•‧

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•‧

N a tio na

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HSC Research and Development Limited Partnership (HSC

) (limited partnership)

Endorecherche Inc. Myriad Genetics &

LaboratoriesInc. (Myriad)

5,654,155 Consensus sequence of the human BRCA1

gene ( BRCA1 ) Murphy

08/598,591 1997 8 5 4 3

ONCORMED, INC. Myriad Genetics

6,033,857 Chromosome 13-linked breast cancer

susceptibility gene (13 ) Tavtigian

09/044,946 2000 3 7 8 4

Myriad Genetics

5,753,441 170-linked breast and ovarian cancer

susceptibility gene (170 ) Skolnick

08/488,011 1998 5 19 37 4

•‧

5,709,999 Linked breast and ovarian cancer

susceptibility gene ( ) Shattuck-Eidens

08/483,553 1998 1 20 35

1 SHATTUCK-EIDENS, DONNA M.

6,951,721 Method for determining the haplotype of a

human BRCA1 gene ( BRCA1 )

Murphy 09/923,327 2005 10 4 19

4 GENE LOGIC ACQUISITION

CORP. Myriad Genetics

7,250,497 Large deletions in human BRCA1 gene and

use thereof ( BRCA1 ) Scholl

10/457,839 7 31 2007 20 1

SCHOLL, THOMAS HENDRICKSON, BRANT C.

WARD, BENJAMINPRUSS, DMITRY Myriad Genetics

5,750,400 Coding sequences of the human BRCA1 gene

( BRCA1 ) Murphy 08/798,691

1998 5 12 8 5

ONCORMED, INC. Myriad Genetics

5,837,492 Chromosome 13-linked breast cancer

•‧

國

立立政治大

㈻㊫學

•‧

N a tio na

l C h engchi U ni ve rs it y

susceptibility gene (13 ) Tavtigian

08/639,501 1998 11 17 30 3

Myriad Genetics

5,747,282 17Q-linked breast and ovarian cancer

susceptibility gene (17Q ) Skolnick

08/483,554 1998 5 5 20 6

Myriad 2013 7 Ambry

Ambry Myriad

Myriad BRCA1/2

Myriad BRCA1 BRCA2

BRCA1 BRCA2

2014 3 10 Myriad

Myriad 2014 12 17

Myriad 5,753, 441 5,747,282 5,837,492

•‧

國

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•‧

N a tio na

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Myriad

Myriad Ambry 2015 2

Myriad 2015 ⁹⁶

Myriad 2014 8

Intron Intron

Intron

DNA Intron

Intron

Intron (Thrombomodulin)

96 2015 2 Ambry Genetics Myriad

•‧

1987 (Proceedings of the National

Academy of Sciences of the United States of America, PNAS) Human thrombomodulin gene is intron depleted: nucleic acid sequences of the cDNA and gene predict protein structure and suggest sites of regulatory control⁹⁸

Intron⁹⁹ - ATP

100 Intron

97 2003

98 Jackman RW, Beeler DL, Fritze L, Soff G, Rosenberg RD. Human thrombomodulin gene is intron depleted: nucleic acid sequences of the cDNA and gene predict protein structure and suggest sites of regulatory control. Proc Natl Acad Sci U S A. 1987 Sep;84(18):6425-9.

99 Tom Strachan and Andrew Read, Human Molecular Genetics (4th Edition, 2010).

100 Leber

(LHON) (MELAS)

http://gene.hpa.gov.tw/index.php?mo=CasebPaper&action=paper1_show&sn=17(Last visited on 2016/02/24)

•‧

Utility Examination Guidelines DNA DNA

DNA

101

DNA

102

Myriad USPTO ,

USPTO Myriad ¹⁰³

101 United States Patent and Trademark Office Utility Examination Guidelines, 66 Fed. Reg. 1092, 1093 (Jan. 5, 2001).

102 Eileen M. Kane, Patenting Genes and Genetic Methods: What's at Stake?, 6 J. BUS. & TECH.

L. 1, 8(2010).

103 "Supreme Court Decision in Association for Molecular Pathology v. Myriad Genetics, Inc.", from Andrew H. Hirshfeld, Deputy Commissoner For Patent Examination Policy

•‧

USPTO Myriad Mayo 2014 3 4 ¹⁰⁵:

(Guidance For Determining Subject Matter Eligibility Of Claims Reciting Or Involving Laws of Nature, Natural Phenomena, & Natural Products)

(significant

difference) Myriad

104 Manual of Patent Examining Procedure (MPEP) 2106 Patent Subject Matter Eligibility, latest revision August 2012, http://www.uspto.gov/web/offices/pac/mpep/s2106.html (Last visited on 2016/01/15)

105 2014 Procedure For Subject Matter Eligibility Analysis Of Claims Reciting Or Involving Laws OfNature/Natural Principles, Natural Phenomena, And/Or Natural Products", from Andrew H.

Hirshfeld, Deputy Commissoner For Patent Examination Policy,

http://www.uspto.gov/patents/law/exam/myriad-mayo_guidance.pdf (Last visited on 2016/01/15)

•‧

國

立立政治大

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•‧

N a tio na

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5-1 USPTO

: Myriad DNA (2016)

3 :

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? , 101

; 2

2: (judicial exceptions)?

3 (

) ( )

( ) ( )

3: (significantly different)

? - MPEP2106 41

( ) ( ) 6

a) g):

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( )

a) g)

DNA ( :1

:2 )

DNA

106

106 Myriad DNA 189 2014 9

•‧

國

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•‧

N a tio na

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-1948 : (the work of nature)

(the laws of nature)

(Product of nature)

(substances) (phenomena) (processes)

1948 Funk Bros Seed Co. v. Kalo Inoculant Co

107

107 : Charkarbarty

•‧

國

立立政治大

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N a tio na

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108

1952 103

Myriad cDNA DNA

cDNA DNA

DNA

cDNA DNA

DNA cDNA DNA

( ) ( )

DNA BRCA

DNA DNA

108

9 2013 12

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N a tio na

l C h engchi U ni ve rs it y

DNA ¹⁰⁹

( )

Diamond v. Chakrabarty

? DNA

109 Guyan Liang, Molecules or Carriers of Biological Information: A Chemist’s Perspective on the Patentability of Isolated Genes, 22 ALB. L.J. SCI. & TECH. 133 (2012)

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110

111

112

Myriad ¹¹³

110 Myraid 181 2012 2

111 2011 136

112

-2011 2012

113 Cancer Voice Austl. V. Myriad Genetics, Inc. 2013 FCA 65 (Austl.).

•‧

2011 9 16 (Leahy-Smith America

Invents Act, AIA)¹¹⁴ 27

(1) (2)

(3) (4)

115

2010 4

(Gene Patents and Licensing Practices and Their Impact on Patient Access to Genetic Tests) ¹¹⁶

117 118

114 Leahy-Smith America Invents Act of 2011, PUBLIC LAW 112–29, 125 Stat. 284 (2011)

115 U.S. Patent & Trademark Office, AIA Studies and Reports—Genetic Testing,

http://www.uspto.gov/aia_implementation/aia_studies_reports.jsp#heading-3 (Last visited on 2015/12/1)

116 Gene Patents and Licensing Practices and Their Impact on Patient Access to Genetic Tests, http://osp.od.nih.gov/sites/default/files/SACGHS_patents_report_2010.pdf (Last visited on 2015/12/1)

117

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119

120

121

Myriad Myriad

118 DNA (patent thicket)

(multiplex test) (whole-genome sequencing)

119

130 2010

120 Jacob D. Moore, The Forgotten victim in Human Gene Patenting Debate: Pharmaceutical Companies, 63 Fla. L. Rev. 1277, 1305-1306 (2011).

121 DNA 28

2012 3

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Myriad

122

Myriad

BRCA1/2 ¹²³

2012 Myriad

Mayo Mayo Myriad

Mayo

Myriad

124

122 AMP v. Myriad Genetics, Inc. 31 2014

123 Miri Yoon, Gene Patenting Debate: Meaning of Myriad Case, 9 J. Marshall Rev. Intell. Prop. L.

953 (2010)

124 Supra note 105, at 32

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125 Angelina Jolie Pitt: Diary of a Surgery, New York Times,

http://www.nytimes.com/2015/03/24/opinion/angelina-jolie-pitt-diary-of-a-surgery.html?smid=fb-nyti mes&smtyp=cur&bicmp=AD&bicmlukp=WT.mc_id&bicmst=1409232722000&bicmet=14197735220 00&_r=0 (Last visited on 2015/12/2)

126 :

mg/dl

http://www.skh.org.tw/blood/test.html ( : 2015 12 2 )

127 2010 (Department of Health and Public Service)

See generally, DEP’T OF HEALTH & HUMAN SERVS., REP. OF THE SEC’Y ADVISORY COMM. ONGENETICS, HEALTH & SOC’Y, GENE PATENTS AND LICENSING PRACTICES AND THEIR IMPACT ONPATIENT ACCESS TO GENETIC TESTS 94 (2010) (discussing how gene patents have limitedpatient access to genetic testing).

128 Arti Rai, Diagnostic Patents at the Supreme Court, 18 MARQ. INTELL. PROP. L. REV. 1, 3 (2014).

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129

Myriad

Myriad cDNA

FDA Myriad

Myriad USPTO

Myriad

Myriad 2013 6 13

129 82

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2012 2013 2014 4.96 6.13 7.78 23.36

23.62 26.92% BRCA DNA

26.92%

6-1 Myriad

FY 2014 FY 2013 FY 2012 FY 2011 FY 2010 2014-06-30 2013-06-30 2012-06-30 2011-06-30 2010-06-30

778.2 613.2 496.0 402.1 362.6

: Bloomberg (2015/03) (2015)

: (1) cDNA

(2)Myriad BRCAnalysis FDA

cDNA PCR cDNA

cDNA cDNA

•‧

Myriad cDNA FDA

Myriad

cDNA FDA

FDA

2015 12 Myriad

BRACAnalysis CDx FDA FDA

7 Prosigna Breast Cancer Prognostic Gene Signature Assay MammaPrint INFORM HER2 Dual ISH DNA Probe Cocktail HER2 CISH pharmDxTM Kit GeneSearch Breast Lymph Node (BLN) Test Kit Dako TOP2A FISH PharmDx Kit DakoCytomation Her2 FISH

pharmDx™ Kit HER2 INFORM HER2

Dual ISH DNA Probe Cocktail HER2 CISH pharmDxTM Kit DakoCytomation

Her2 FISH pharmDx™ Kit Myriad

BRACAnalysis CDx FDA Myriad

•‧

Disease Trade Name Manufacturer FDA Submission

number

Vysis D7S486/CEP 7 FISH Probe Kit Abbott Molecular Inc.

K131508 Acute

Myeloid

Leukemia Vysis EGR1 FISH Probe Kit Abbott Molecular Inc.

K123951,K091960

Vysis CLL FISH Probe Kit Vysis K100015

B-cell chronic lymphocytic leukemia

CEP 12 SpectrumOrange Direct Labeled Chromosome Enumeration DNA Probe

Vysis K962873

Bladder Cancer

Vysis UroVysion Bladder Cancer Recurrence Kit

Vysis K033982,K013785,K0

11031 Prosigna Breast Cancer Prognostic Gene

Signature Assay

Nanostring Technologies

K130010

MammaPrint Agendia BV K101454,K081092,K0

80252,K070675,K0626 94

INFORM HER2 Dual ISH DNA Probe Cocktail

Ventana Medical Systems, Inc.

P100027 HER2 CISH pharmDxTM Kit Dako Denmark A/S P100024 GeneSearch Breast Lymph Node (BLN)

Test Kit

Veridex, LLC. P060017S001-S004 Dako TOP2A FISH PharmDx Kit Dako Denmark A/S P050045S001-S004 Breast

Cancer

DakoCytomation Her2 FISH pharmDx™

Kit

DakoCytomation Denmark A/S

P040005 Colorectal

Cancer

Cologuard Exact Sciences

Corporation

P130017 Illumina MiSeqDx Cystic Fibrosis Clinical

Sequencing Assay

Illumina, Inc K132750 Illumina MiSeqDx Cystic Fibrosis

139-Variant Assay

Illumina, Inc K124006 eSensor CF Genotyping Test Osmetech

Molecular Diagnostics

K090901

xTAG Cystic Fibrosis 60 Kit v2 Luminex Molecular Diagnostics Inc.

K083845 Cystic

Fibrosis

xTAG Cystic Fibrosis 39 Kit v2 Luminex Molecular Diagnostics Inc.

K083846

130 List of Human Genetic Tests, FDA,

http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/InVitroDiagnostics/ucm330711.ht m (Last visited on 2015/12/28)

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Verigene CFTR and Verigene CFTR PolyT Nucleic Acid Tests

Nanosphere, Inc K083294 InPlex CF Molecular Test Third Wave

Technology, Inc.

K063787 Cystic Fibrosis Genotyping Assay Celera Diagnostics K062028 Tag-It Cystic Fibrosis Kit Tm Bioscience

Corporation

K060627,K043011 eSensor Cystic Fibrosis Carrier Detection

System

Clinical Micro Sensors, Inc.

K060543,K051435

xTAG CYP2D6 Kit v3 Luminex Molecular

Diagnostics, Inc.

K130189,K093420 Spartan RX CYP2C19 Test System Spartan Bioscience,

Inc.

K123891 Verigene CYP2C 19 Nucleic Acid Test Nanosphere, Inc. K120466 INFINITI CYP2C19 Assay AutoGenomics, Inc. K101683 Invader UGT1A1 Molecular Assay Third Wave

Technologies Inc.

K051824 Roche AmpliChip CYP450 microarray Roche Molecular

Systems, Inc.

K043576,K042259 eSensor Warfarin Sensitivity Saliva Test GenMark

Diagnostics

K110786 eQ-PCR LC Warfarin Genotyping kit TrimGen

Corporation

K073071 eSensor Warfarin Sensitivity Test and

XT-8 Instrument

Osmetech Molecular Diagnostics

K073720

Gentris Rapid Genotyping Assay - CYP2C9 & VKORCI

ParagonDx, LLC K071867 INFINITI 2C9 & VKORC1 Multiplex

Assay for Warfarin

AutoGenomics, Inc. K073014 Drug

metabolizing enzymes

Verigene Warfarin Metabolism Nucleic Acid Test and Verigene System

Nanosphere, Inc. K070804

Invader Factor V Hologic, Inc. K100980

Invader Factor II Hologic, Inc. K100943

在文檔中 Myriad案後基因檢測產業之問題與挑戰 - 政大學術集成 (頁 51-139)