sam s. han, ph.d., j.d. assistant professor of law ......also applied to other patents that are...
TRANSCRIPT
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Sam S. Han, Ph.D., J.D.
Assistant Professor of Law
University of Dayton
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SAM HAN
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SAM HAN
Slauson Middle School, Ann Arbor, MI
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SAM HAN
Slauson Middle School, Ann Arbor, MI
1984
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SAM HAN
Slauson Middle School, Ann Arbor, MI
1984
Pioneer High School, Ann Arbor, MI
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SAM HAN
Slauson Middle School, Ann Arbor, MI
1984
Pioneer High School, Ann Arbor, MI
1988
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SAM HAN
Slauson Middle School, Ann Arbor, MI
1984
Pioneer High School, Ann Arbor, MI
1988
University of Michigan, Ann Arbor, MI
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SAM HAN
Slauson Middle School, Ann Arbor, MI
1984
Pioneer High School, Ann Arbor, MI
1988
University of Michigan, Ann Arbor, MI
1992
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Intersection of two (2) patent-law doctrines:
Patentable subject matter
Inequitable Conduct
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Intersection of two (2) patent-law doctrines:
Patentable subject matter
Inequitable Conduct
Inequitable Conduct
Therasense v. Becton, Dickinson & Co., Case No. 2008-
1511 (Fed. Cir., May 25, 2011).
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Intersection of two (2) patent-law doctrines:
Patentable subject matter
Inequitable Conduct
Inequitable Conduct
Therasense v. Becton, Dickinson & Co., Case No. 2008-
1511 (Fed. Cir., May 25, 2011).
Patentable Subject Matter
Assoc. of Molecular Pathology v. USPTO, 702 F. Supp. 2d
181 (S.D.N.Y. 2010).
Assoc. of Molecular Pathology v. USPTO, Case No. 2010-
1406 (Fed. Cir., July 29, 2011).
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What happens if an inventor applies for
something that the inventor believes to be non-
statutory subject matter, and does not tell the
USPTO?
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What if the inventor's attorney (or other
relevant individual) believes that the invention
is non-statutory subject matter, but deliberately
withholds that information from the USPTO?
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GENES
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GENES
basic unit of heredity in a
living organism
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GENES
basic unit of heredity in a
living organism
hold information to pass
genetic traits to offspring
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GENES
basic unit of heredity in a
living organism
hold information to pass
genetic traits to offspring
correspond to many
different biological traits
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GENES
basic unit of heredity in a
living organism
hold information to pass
genetic traits to offspring
correspond to many
different biological traits
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GENES
basic unit of heredity in a
living organism
hold information to pass
genetic traits to offspring
correspond to many
different biological traits
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GENES
basic unit of heredity in a
living organism
hold information to pass
genetic traits to offspring
correspond to many
different biological traits
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GENES
basic unit of heredity in a
living organism
hold information to pass
genetic traits to offspring
correspond to many
different biological traits
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GENES
basic unit of heredity in a
living organism
hold information to pass
genetic traits to offspring
correspond to many
different biological traits
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GOOD GENES
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GENES
basic unit of heredity in a
living organism
hold information to pass
genetic traits to offspring
correspond to many
different biological traits
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GOOD GENES
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GENES
basic unit of heredity in a
living organism
hold information to pass
genetic traits to offspring
correspond to many
different biological traits
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BAD GENES
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GENES
basic unit of heredity in a
living organism
hold information to pass
genetic traits to offspring
correspond to many
different biological traits
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BAD GENES
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GENES
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GENES
Hold information to build and
maintain cells
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GENES
Hold information to build and
maintain cells
Control basic biochemical
processes of life
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GENES
Hold information to build and
maintain cells
Control basic biochemical
processes of life
Determine risk for specific
diseases
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GENES
Hold information to build and
maintain cells
Control basic biochemical
processes of life
Determine risk for specific
diseases
Including Breast Cancer
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GENES
Hold information to build and
maintain cells
Control basic biochemical
processes of life
Determine risk for specific
diseases
Including Breast Cancer
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BRCA1
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GENES
Hold information to build and
maintain cells
Control basic biochemical
processes of life
Determine risk for specific
diseases
Including Breast Cancer
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BRCA1
BRCA2
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BREAST CANCER
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BRCA1
BRCA2
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BREAST CANCER
U.S. Statistics
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BRCA1
BRCA2
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BREAST CANCER
U.S. Statistics
~216,000 cases
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BRCA1
BRCA2
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BREAST CANCER
U.S. Statistics
~216,000 cases
~40,000 deaths
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BRCA1
BRCA2
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BREAST CANCER
U.S. Statistics
~216,000 cases
~40,000 deaths
Worldwide Statistics
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BRCA1
BRCA2
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BREAST CANCER
U.S. Statistics
~216,000 cases
~40,000 deaths
Worldwide Statistics
second most common type of cancer
(after lung cancer)
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BRCA1
BRCA2
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BREAST CANCER
U.S. Statistics
~216,000 cases
~40,000 deaths
Worldwide Statistics
second most common type of cancer
(after lung cancer)
fifth most common cause of cancer
death
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BRCA1
BRCA2
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BREAST CANCER
U.S. Statistics
~216,000 cases
~40,000 deaths
Worldwide Statistics
second most common type of cancer
(after lung cancer)
fifth most common cause of cancer
death
caused ~519,000 deaths
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BRCA1
BRCA2
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BREAST CANCER
U.S. Statistics
~216,000 cases
~40,000 deaths
Worldwide Statistics
second most common type of cancer
(after lung cancer)
fifth most common cause of cancer
death
caused ~519,000 deaths
almost 1% of all deaths
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BRCA1
BRCA2
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BREAST CANCER
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BRCA1
BRCA2
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BREAST CANCER
Other Relevant Statistics
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BRCA1
BRCA2
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BREAST CANCER
Other Relevant Statistics
30-year old woman
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BRCA1
BRCA2
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BREAST CANCER
Other Relevant Statistics
30-year old woman
Approximately 1 in 2,525 chance of
developing breast cancer
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BRCA1
BRCA2
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BREAST CANCER
Other Relevant Statistics
30-year old woman
Approximately 1 in 2,525 chance of
developing breast cancer
WITH BRCA
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BRCA1
BRCA2
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BREAST CANCER
Other Relevant Statistics
30-year old woman
Approximately 1 in 2,525 chance of
developing breast cancer
WITH BRCA
RISK INCREASES TO
1 IN 3 52
BRCA1
BRCA2
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OVARIAN CANCER
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BRCA1
BRCA2
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OVARIAN CANCER
BRCA genes also increase the
predisposition to ovarian cancer
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BRCA1
BRCA2
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Items within the scope of this presentation
Overview of patentable subject matter
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Items within the scope of this presentation
Overview of patentable subject matter
Inequitable conduct analysis
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Items beyond the scope of this presentation
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Items beyond the scope of this presentation
Detailed claim analysis for patents-in-suit
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Items beyond the scope of this presentation
Detailed claim analysis for patents-in-suit
In-depth analysis of all other legal issues
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35 USC § 101
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35 USC § 101
"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."
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35 USC § 101
"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."
Diamond v. Diehr, 450 U.S. 175 (1981)
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35 USC § 101
"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."
Diamond v. Diehr, 450 U.S. 175 (1981)
Congress intended statutory subject matter to
"include anything under the sun that is made by
man."
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Exception
66
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Exception
Laws of Nature
67
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Exception
Laws of Nature
Natural Phenomenon
68
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Exception
Laws of Nature
Natural Phenomenon
Abstract Idea
69
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35 USC § 115 (Oath or Declaration)
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35 USC § 115 (Oath or Declaration)
“The applicant shall make oath that he believes himself to be the original and first inventor . . . . Such oath may be made before any person within the United States authorized by law to administer oaths . . . .”
71
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37 CFR 1.63: Oath or declaration.
72
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37 CFR 1.63: Oath or declaration. “[T]he oath or declaration must also:
73
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37 CFR 1.63: Oath or declaration. “[T]he oath or declaration must also:
“(3) State that the person making the oath or declaration acknowledges the duty to disclose to the Office all information known to the person to be material to patentability . . . .”
74
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Therasense v. Becton, Case No. 2008-1511 (Fed. Cir.
May 25, 2011)
Inequitable Conduct requires both:
Intent; and
Materiality.
75
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Therasense v. Becton, Case No. 2008-1511 (Fed. Cir.
May 25, 2011)
Inequitable Conduct requires both:
Intent; and
Materiality.
Intent if individual:
Knew information;
Knew that information was material; and
Made a deliberate decision to withhold information.
76
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Therasense v. Becton, Case No. 2008-1511 (Fed. Cir.
May 25, 2011)
Inequitable Conduct requires both:
Intent; and
Materiality.
Intent if individual:
Knew information;
Knew that information was material; and
Made a deliberate decision to withhold information.
Materiality:
"if a claim is properly invalidated in district court based on the
deliberately withheld reference, then that reference is necessarily
material" 77
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Inequitable conduct in procuring any claim within a patent will result in the unenforceability of the entire patent. Kingsdown Med. Consultants, Ltd. v. Hollister Inc., 863 F.2d 867
(Fed. Cir. 1988).
This theory is often termed "infectious unenforceability." Baxter Int'l Inc. v. McGaw, Inc., 958 F. Supp 1313, 1315 (N.D. Ill. 1997),
aff'd in part, rev'd in part, 149 F.3d 1321 (Fed. Cir. 1998).
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Also applied to other patents that are "genealogically related to the original application as to which inequitable conduct has been found." Baxter Int'l Inc. v. McGaw, Inc., 958 F. Supp 1313, 1315 (N.D. Ill. 1997),
aff'd in part, rev'd in part, 149 F.3d 1321 (Fed. Cir. 1998).
Inequitable conduct in procuring a single claim within a single patent can result in the unenforceability of an entire family of patents. Nilssen v. Osram Sylvania, Inc., 504 F.3d 1223, 1230 (Fed. Cir. 2007).
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80
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The National Center for Human Genome
Research (National Institutes of Health)
Players
81
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The National Center for Human Genome
Research (National Institutes of Health)
Players
Bernadine Healy (+)
82
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The National Center for Human Genome
Research (National Institutes of Health)
Players
Bernadine Healy (+)
James D. Watson (-)
83
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The National Center for Human Genome
Research (National Institutes of Health)
Players
Bernadine Healy (+)
James D. Watson (-)
J. Craig Venter (+)
84
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The National Center for Human Genome
Research (National Institutes of Health)
Players
Bernadine Healy (+)
James D. Watson (-)
J. Craig Venter (+)
Francis Collins (=)
85
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86
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MARGARET B. COLLINS-HILL
87
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MARGARET B. COLLINS-HILL
88
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MARGARET B. COLLINS-HILL
Pioneer High School, Ann Arbor, MI
89
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MARGARET B. COLLINS-HILL
Pioneer High School, Ann Arbor, MI
1988
90
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MARGARET B. COLLINS-HILL
Pioneer High School, Ann Arbor, MI
1988
University of Michigan, Ann Arbor, MI
91
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MARGARET B. COLLINS-HILL
Pioneer High School, Ann Arbor, MI
1988
University of Michigan, Ann Arbor, MI
1992
92
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MARGARET B. COLLINS-HILL
Pioneer High School, Ann Arbor, MI
1988
University of Michigan, Ann Arbor, MI
1992
Genetically-predisposed to avoiding people
with bad genes
93
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MARGARET B. COLLINS-HILL
Pioneer High School, Ann Arbor, MI
1988
University of Michigan, Ann Arbor, MI
1992
Genetically-predisposed to avoiding people
with bad genes
94
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GENETIC EQUATION
95
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GENETIC EQUATION
+
96
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GENETIC EQUATION
+ =
97
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GENETIC EQUATION
+ =
Courtesy of <http://www.MorphThing.com>
98
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The National Center for Human Genome
Research (National Institutes of Health)
Players
Bernadine Healy (+)
James D. Watson (-)
J. Craig Venter (+)
Francis Collins (=)
Timeline
99
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The National Center for Human Genome
Research (National Institutes of Health)
Players
Bernadine Healy (+)
James D. Watson (-)
J. Craig Venter (+)
Francis Collins (=)
Timeline 1991: NIH Seeks Patents on Gene Fragments
100
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The National Center for Human Genome
Research (National Institutes of Health)
Players
Bernadine Healy (+)
James D. Watson (-)
J. Craig Venter (+)
Francis Collins (=)
Timeline 1991: NIH Seeks Patents on Gene Fragments
1992: James D. Watson Resigns
101
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The National Center for Human Genome
Research (National Institutes of Health)
Players
Bernadine Healy (+)
James D. Watson (-)
J. Craig Venter (+)
Francis Collins (=)
Timeline 1991: NIH Seeks Patents on Gene Fragments
1992: James D. Watson Resigns
1993: Francis Collins Appointed
102
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103
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Myriad's Patents
104
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Myriad's Patents
Allegedly covering natural human genes
105
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Myriad's Patents
Allegedly covering natural human genes
U.S. Patent Number 5,727,282
U.S. Patent Number 5,837,492
106
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Myriad's Patents
Allegedly covering natural human genes
U.S. Patent Number 5,727,282
U.S. Patent Number 5,837,492
Allegedly covering natural mutations
107
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Myriad's Patents
Allegedly covering natural human genes
U.S. Patent Number 5,727,282
U.S. Patent Number 5,837,492
Allegedly covering natural mutations
U.S. Patent Number 5,693,473
U.S. Patent Number 5,727,282
U.S. Patent Number 5,837,492
108
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Myriad's Patents
Allegedly covering natural human genes
U.S. Patent Number 5,727,282
U.S. Patent Number 5,837,492
Allegedly covering natural mutations
U.S. Patent Number 5,693,473
U.S. Patent Number 5,727,282
U.S. Patent Number 5,837,492
Allegedly covering methods for looking for mutations
109
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Myriad's Patents
Allegedly covering natural human genes
U.S. Patent Number 5,727,282
U.S. Patent Number 5,837,492
Allegedly covering natural mutations
U.S. Patent Number 5,693,473
U.S. Patent Number 5,727,282
U.S. Patent Number 5,837,492
Allegedly covering methods for looking for mutations
U.S. Patent Number 5,709,999
110
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Myriad's Patents
Allegedly covering natural human genes
U.S. Patent Number 5,727,282
U.S. Patent Number 5,837,492
Allegedly covering natural mutations
U.S. Patent Number 5,693,473
U.S. Patent Number 5,727,282
U.S. Patent Number 5,837,492
Allegedly covering methods for looking for mutations
U.S. Patent Number 5,709,999
Patents that correlate genes to increased risk of breast cancer
111
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Myriad's Patents
Allegedly covering natural human genes
U.S. Patent Number 5,727,282
U.S. Patent Number 5,837,492
Allegedly covering natural mutations
U.S. Patent Number 5,693,473
U.S. Patent Number 5,727,282
U.S. Patent Number 5,837,492
Allegedly covering methods for looking for mutations
U.S. Patent Number 5,709,999
Patents that correlate genes to increased risk of breast cancer
U.S. Patent Number 5,727,282
U.S. Patent Number 5,710,001
U.S. Patent Number 5,753,441
U.S. Patent Number 6,033,857
112
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Myriad's Patents
113
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Myriad's Patents
Co-Owners
114
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Myriad's Patents
Co-Owners
Myriad Genetics (Delaware corporation; Utah presence)
115
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Myriad's Patents
Co-Owners
Myriad Genetics (Delaware corporation; Utah presence)
University of Utah Research Foundation (Salt Lake City, Utah)
116
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Myriad's Patents
Co-Owners
Myriad Genetics (Delaware corporation; Utah presence)
University of Utah Research Foundation (Salt Lake City, Utah)
United States of America (Secretary of Health and Human Services)
117
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Myriad's Patents
Co-Owners
Myriad Genetics (Delaware corporation; Utah presence)
University of Utah Research Foundation (Salt Lake City, Utah)
United States of America (Secretary of Health and Human Services)
Endo Recherche, Inc. (Quebec, Canada)
118
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Myriad's Patents
Co-Owners
Myriad Genetics (Delaware corporation; Utah presence)
University of Utah Research Foundation (Salt Lake City, Utah)
United States of America (Secretary of Health and Human Services)
Endo Recherche, Inc. (Quebec, Canada)
HSC Research and Development Limited Partnership (Toronto, Canada)
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Myriad's Patents
Co-Owners
Myriad Genetics (Delaware corporation; Utah presence)
University of Utah Research Foundation (Salt Lake City, Utah)
United States of America (Secretary of Health and Human Services)
Endo Recherche, Inc. (Quebec, Canada)
HSC Research and Development Limited Partnership (Toronto, Canada)
Trustees of the University of Pennsylvania
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The Events Leading Up to the Lawsuit
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The Events Leading Up to the Lawsuit Myriad Genetics v. University of Pennsylvania, 2:98-cv-
00829 (D. Utah 1998)
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The Events Leading Up to the Lawsuit Myriad Genetics v. University of Pennsylvania, 2:98-cv-
00829 (D. Utah 1998)
Patent infringement against Drs. Kazazian and Ganguly's
laboratory for BRCA testing
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The Events Leading Up to the Lawsuit Myriad Genetics v. University of Pennsylvania, 2:98-cv-
00829 (D. Utah 1998)
Patent infringement against Drs. Kazazian and Ganguly's
laboratory for BRCA testing
Dismissed by agreement when Drs. Kazazian and Ganguly
agreed to stop infringing activity
125
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The Events Leading Up to the Lawsuit Myriad Genetics v. University of Pennsylvania, 2:98-cv-
00829 (D. Utah 1998)
Patent infringement against Drs. Kazazian and Ganguly's
laboratory for BRCA testing
Dismissed by agreement when Drs. Kazazian and Ganguly
agreed to stop infringing activity
The Plaintiffs' Saga
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The Events Leading Up to the Lawsuit Myriad Genetics v. University of Pennsylvania, 2:98-cv-
00829 (D. Utah 1998)
Patent infringement against Drs. Kazazian and Ganguly's
laboratory for BRCA testing
Dismissed by agreement when Drs. Kazazian and Ganguly
agreed to stop infringing activity
The Plaintiffs' Saga
Several individuals wanted to get a "second opinion" (other than
from Myriad) on whether or not they were at an increased risk of
breast cancer
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The Events Leading Up to the Lawsuit Myriad Genetics v. University of Pennsylvania, 2:98-cv-
00829 (D. Utah 1998)
Patent infringement against Drs. Kazazian and Ganguly's
laboratory for BRCA testing
Dismissed by agreement when Drs. Kazazian and Ganguly
agreed to stop infringing activity
The Plaintiffs' Saga
Several individuals wanted to get a "second opinion" (other than
from Myriad) on whether or not they were at an increased risk of
breast cancer
Due to Myriad's patents, they could not get re-tested elsewhere
128
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Gene Patents and Genetic Research
Timeline
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Gene Patents and Genetic Research
Timeline 1990: Human Genome Project begins
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Gene Patents and Genetic Research
Timeline 1990: Human Genome Project begins
Under the direction of Dr. James D. Watson
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Gene Patents and Genetic Research
Timeline 1990: Human Genome Project begins
Under the direction of Dr. James D. Watson
Projected Completion in Fifteen Years
132
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Gene Patents and Genetic Research
Timeline 1990: Human Genome Project begins
Under the direction of Dr. James D. Watson
Projected Completion in Fifteen Years
1991: Dr. CraigVenter (NIH) seeks patents on gene fragment
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Gene Patents and Genetic Research
Timeline 1990: Human Genome Project begins
Under the direction of Dr. James D. Watson
Projected Completion in Fifteen Years
1991: Dr. CraigVenter (NIH) seeks patents on gene fragment
Sparks Controversy
134
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Gene Patents and Genetic Research
Timeline 1990: Human Genome Project begins
Under the direction of Dr. James D. Watson
Projected Completion in Fifteen Years
1991: Dr. CraigVenter (NIH) seeks patents on gene fragment
Sparks Controversy
Race from Both Sides to Sequence as Many Genes as Possible
135
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Gene Patents and Genetic Research
Timeline 1990: Human Genome Project begins
Under the direction of Dr. James D. Watson
Projected Completion in Fifteen Years
1991: Dr. CraigVenter (NIH) seeks patents on gene fragment
Sparks Controversy
Race from Both Sides to Sequence as Many Genes as Possible
1992: Dr. James D. Watson Resigns
136
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Gene Patents and Genetic Research
Timeline 1990: Human Genome Project begins
Under the direction of Dr. James D. Watson
Projected Completion in Fifteen Years
1991: Dr. CraigVenter (NIH) seeks patents on gene fragment
Sparks Controversy
Race from Both Sides to Sequence as Many Genes as Possible
1992: Dr. James D. Watson Resigns
1993: Dr. Francis Collins Appointed
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Gene Patents and Genetic Research
Timeline 1990: Human Genome Project begins
Under the direction of Dr. James D. Watson
Projected Completion in Fifteen Years
1991: Dr. CraigVenter (NIH) seeks patents on gene fragment
Sparks Controversy
Race from Both Sides to Sequence as Many Genes as Possible
1992: Dr. James D. Watson Resigns
1993: Dr. Francis Collins Appointed
2000: The Entire Human Genome is Encoded
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Gene Patents and Genetic Research
Timeline 1990: Human Genome Project begins
Under the direction of Dr. James D. Watson
Projected Completion in Fifteen Years
1991: Dr. CraigVenter (NIH) seeks patents on gene fragment
Sparks Controversy
Race from Both Sides to Sequence as Many Genes as Possible
1992: Dr. James D. Watson Resigns
1993: Dr. Francis Collins Appointed
2000: The Entire Human Genome is Encoded
Rough Draft Released
139
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Gene Patents and Genetic Research
Timeline 1990: Human Genome Project begins
Under the direction of Dr. James D. Watson
Projected Completion in Fifteen Years
1991: Dr. CraigVenter (NIH) seeks patents on gene fragment
Sparks Controversy
Race from Both Sides to Sequence as Many Genes as Possible
1992: Dr. James D. Watson Resigns
1993: Dr. Francis Collins Appointed
2000: The Entire Human Genome is Encoded
Rough Draft Released
Five (5) Years Ahead of Schedule
140
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Gene Patents and Genetic Research
Timeline 1990: Human Genome Project begins
Under the direction of Dr. James D. Watson
Projected Completion in Fifteen Years
1991: Dr. CraigVenter (NIH) seeks patents on gene fragment
Sparks Controversy
Race from Both Sides to Sequence as Many Genes as Possible
1992: Dr. James D. Watson Resigns
1993: Dr. Francis Collins Appointed
2000: The Entire Human Genome is Encoded
Rough Draft Released
Five (5) Years Ahead of Schedule
2003: Human Genome Officially Confirmed 141
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142
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The Plaintiffs
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The Plaintiffs
Dr. Haig Kazazian
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The Plaintiffs
Dr. Haig Kazazian
Professor of Molecular
Medicine in Genetics
145
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The Plaintiffs
Dr. Haig Kazazian
Professor of Molecular
Medicine in Genetics
Department of Genetics
146
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The Plaintiffs
Dr. Haig Kazazian
Professor of Molecular
Medicine in Genetics
Department of Genetics
University of Pennsylvania
School of Medicine
147
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The Plaintiffs
Dr. Arupa Ganguly
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The Plaintiffs
Dr. Arupa Ganguly
Associate Professor
149
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The Plaintiffs
Dr. Arupa Ganguly
Associate Professor
Department of Genetics
150
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The Plaintiffs
Dr. Arupa Ganguly
Associate Professor
Department of Genetics
Hospital of the University of
Pennsylvania
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The Plaintiffs
Dr. Wendy Chung
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The Plaintiffs
Dr. Wendy Chung
Associate Professor of
Pediatrics
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The Plaintiffs
Dr. Wendy Chung
Associate Professor of
Pediatrics
Columbia University
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The Plaintiffs
Drs. David Ledbetter and
Stephen Warren
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The Plaintiffs
Drs. David Ledbetter and
Stephen Warren
Professors of Human
Genetics
156
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The Plaintiffs
Drs. David Ledbetter and
Stephen Warren
Professors of Human
Genetics
Emory University
157
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The Defendants
158
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The Defendants
The United States Patent and
Trademark Office
159
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The Defendants
The United States Patent and
Trademark Office
Myriad Genetics
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The Defendants
The United States Patent and
Trademark Office
Myriad Genetics
Directors of the University
of Utah Research Foundation
161
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The Venue
162
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The Venue
The United States District
Court for the Southern
District of New York
163
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The Allegations
164
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The Allegations
35 USC § 101
165
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The Allegations
35 USC § 101
Patents on genes should not be allowed
166
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The Allegations
35 USC § 101
Patents on genes should not be allowed
Patents on natural mutations should not be allowed
167
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The Allegations
35 USC § 101
Patents on genes should not be allowed
Patents on natural mutations should not be allowed
Patents on looking for mutations should not be allowed
168
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The Allegations
35 USC § 101
Patents on genes should not be allowed
Patents on natural mutations should not be allowed
Patents on looking for mutations should not be allowed
First Amendment and Fourteenth Amendment
169
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The Allegations
35 USC § 101
Patents on genes should not be allowed
Patents on natural mutations should not be allowed
Patents on looking for mutations should not be allowed
First Amendment and Fourteenth Amendment
Patents on human knowledge and abstract ideas should
not be allowed
170
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The Allegations
Rationale for Plaintiffs' argument is equally
applicable to all isolated sequences (e.g.,
nucleotide, amino acid, peptide, or polypeptide
sequences)
171
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Motions to Dismiss
172
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Motions to Dismiss
USPTO
173
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Motions to Dismiss
USPTO
Myriad
174
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Motion for Summary
Judgment
175
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Motion for Summary
Judgment
Plaintiffs
176
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Motion for Summary
Judgment
Plaintiffs
Affidavits from Chung,
Ostrer, and Ledbetter
177
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178
The Court’s Order
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The Court’s Order
“Defendants’
motion to dismiss
the Complaint is
denied”
179
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180
The Court’s Order
“Defendants’
motion to dismiss
the Complaint is
denied”
November 1, 2009
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181
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Plaintiffs and Their Institutional Affiliations
182
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Plaintiffs and Their Institutional Affiliations
University of Pennsylvania
183
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Plaintiffs and Their Institutional Affiliations
University of Pennsylvania
Dr. Kazazian
Dr. Ganguly
184
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Plaintiffs and Their Institutional Affiliations
University of Pennsylvania
Dr. Kazazian
Dr. Ganguly
Columbia
185
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Plaintiffs and Their Institutional Affiliations
University of Pennsylvania
Dr. Kazazian
Dr. Ganguly
Columbia
Dr. Chung
186
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Plaintiffs and Their Institutional Affiliations
University of Pennsylvania
Dr. Kazazian
Dr. Ganguly
Columbia
Dr. Chung
New York University
187
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Plaintiffs and Their Institutional Affiliations
University of Pennsylvania
Dr. Kazazian
Dr. Ganguly
Columbia
Dr. Chung
New York University
Dr. Ostrer
Prof. Reich
188
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Plaintiffs and Their Institutional Affiliations
University of Pennsylvania
Dr. Kazazian
Dr. Ganguly
Columbia
Dr. Chung
New York University
Dr. Ostrer
Prof. Reich
189
Emory
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Plaintiffs and Their Institutional Affiliations
University of Pennsylvania
Dr. Kazazian
Dr. Ganguly
Columbia
Dr. Chung
New York University
Dr. Ostrer
Prof. Reich
190
Emory
Dr. Ledbetter
Dr. Warren
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Plaintiffs and Their Institutional Affiliations
University of Pennsylvania
Dr. Kazazian
Dr. Ganguly
Columbia
Dr. Chung
New York University
Dr. Ostrer
Prof. Reich
191
Emory
Dr. Ledbetter
Dr. Warren
Yale
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Plaintiffs and Their Institutional Affiliations
University of Pennsylvania
Dr. Kazazian
Dr. Ganguly
Columbia
Dr. Chung
New York University
Dr. Ostrer
Prof. Reich
192
Emory
Dr. Ledbetter
Dr. Warren
Yale
Dir. Matloff
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University of Pennsylvania
Columbia
New York University
Emory
Yale
Plaintiffs and Their Institutional Affiliations
193
Why are only the individual doctors and professors
plaintiffs, and not any of the academic institutions?
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194
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Search of Patents and Applications
Search Terms:
Assignee: New York University, Columbia University,
University of Pennsylvania, Emory University, or Yale
University
With in the claims: SEQ ID or sequence or gene or protein
or isolated or nucleic or RNA or DNA or peptide or
polynucleotide or polypeptide or epitope or antibody
Pending between: 5.12.2009 through 7.19.2011
Compared each claimed sequence to GenBank
195
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196
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Issued Patents by Affiliate Institutions
197
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Issued Patents by Affiliate Institutions
University of Pennsylvania
At least 74 patents on isolated sequences
198
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Issued Patents by Affiliate Institutions
University of Pennsylvania
At least 74 patents on isolated sequences
New York University
At least 75 patents on isolated sequences
199
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Issued Patents by Affiliate Institutions
University of Pennsylvania
At least 74 patents on isolated sequences
New York University
At least 75 patents on isolated sequences
Columbia University
At least 43 patents on isolated sequences
200
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Issued Patents by Affiliate Institutions
University of Pennsylvania
At least 74 patents on isolated sequences
New York University
At least 75 patents on isolated sequences
Columbia University
At least 43 patents on isolated sequences
Emory University
At least 16 patents on isolated sequences
201
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Issued Patents by Affiliate Institutions
University of Pennsylvania
At least 74 patents on isolated sequences
New York University
At least 75 patents on isolated sequences
Columbia University
At least 43 patents on isolated sequences
Emory University
At least 16 patents on isolated sequences
Yale
At least 35 patents on isolated sequences
202
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Patent Applications by Affiliate Institutions
203
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Patent Applications by Affiliate Institutions
University of Pennsylvania
At least 31 published applications on isolated sequences
204
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Patent Applications by Affiliate Institutions
University of Pennsylvania
At least 31 published applications on isolated sequences
New York University
At least 37 published applications on isolated sequences
205
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Patent Applications by Affiliate Institutions
University of Pennsylvania
At least 31 published applications on isolated sequences
New York University
At least 37 published applications on isolated sequences
Columbia University
At least 22 published applications on isolated sequences
206
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Patent Applications by Affiliate Institutions
University of Pennsylvania
At least 31 published applications on isolated sequences
New York University
At least 37 published applications on isolated sequences
Columbia University
At least 22 published applications on isolated sequences
Emory University
At least 6 published applications on isolated sequences
207
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Patent Applications by Affiliate Institutions
University of Pennsylvania
At least 31 published applications on isolated sequences
New York University
At least 37 published applications on isolated sequences
Columbia University
At least 22 published applications on isolated sequences
Emory University
At least 6 published applications on isolated sequences
Yale
At least 6 published applications on isolated sequences
208
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Other Miscellaneous Items
209
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Other Miscellaneous Items
U.S. Patent Application Number 10/216,122
210
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Other Miscellaneous Items
U.S. Patent Application Number 10/216,122
Claim 5
211
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Other Miscellaneous Items
U.S. Patent Application Number 10/216,122
Claim 8 (as originally filed)
"A method of isolating a nucleic acid molecule from a genome of an offspring of an animal . . . ."
212
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Other Miscellaneous Items
U.S. Patent Application Number 10/216,122
Claim 8 (as originally filed)
"A method of isolating a nucleic acid molecule from a genome of an offspring of an animal . . . ."
Recall - 37 CFR 1.63?
213
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Other Miscellaneous Items
U.S. Patent Application Number 10/216,122
Claim 8 (as originally filed)
"A method of isolating a nucleic acid molecule from a genome of an offspring of an animal . . . ."
Recall - 37 CFR 1.63?
“[T]he oath or declaration must also: “(3) State that the person making the oath or declaration
acknowledges the duty to disclose to the Office all information known to the person to be material to patentability . . . .”
214
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Other Miscellaneous Items
U.S. Patent Application Number 10/216,122
Claim 8 (as originally filed)
"A method of isolating a nucleic acid molecule from a genome of an offspring of an animal . . . ."
Oath (or Declaration)
215
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Other Miscellaneous Items
U.S. Patent Application Number 10/216,122
Claim 8 (as originally filed)
"A method of isolating a nucleic acid molecule from a genome of an offspring of an animal . . . ."
Oath (or Declaration)
216
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Other Miscellaneous Items
U.S. Patent Application Number 10/216,122
Oath (or Declaration)
Signatures
217
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Other Miscellaneous Items
U.S. Patent Number 5,874,212
218
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Other Miscellaneous Items
U.S. Patent Number 5,874,212
Field of Invention
219
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Other Miscellaneous Items
U.S. Patent Number 5,874,212
Claims 1 and 8
"A method for detecting one or more base pair mutations in a
nucleic acid sequence . . . ."
220
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Other Miscellaneous Items
U.S. Patent Number 5,874,212
Claims 1 and 8
"A method for detecting one or more base pair mutations in a
nucleic acid sequence . . . ."
Inventor
221
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Other Miscellaneous Items
U.S. Patent Number 5,874,212
Claims 1 and 8
"A method for detecting one or more base pair mutations in a
nucleic acid sequence . . . ."
Inventor
Arupa Ganguly (University of Pennsylvania)
222
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Other Miscellaneous Items
U.S. Patent Number 7,339,028
223
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Other Miscellaneous Items
U.S. Patent Number 7,339,028
Claim 1
224
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Other Miscellaneous Items
U.S. Patent Number 7,339,028
Claim 1
An isolated human mahoganoid polypeptide comprising amino
acids the sequence of which is set forth in SEQ ID NO:8
225
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Other Miscellaneous Items
U.S. Patent Number 7,339,028
Claim 1
An isolated human mahoganoid polypeptide comprising amino
acids the sequence of which is set forth in SEQ ID NO:8
Inventor
226
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Other Miscellaneous Items
U.S. Patent Number 7,339,028
Claim 1
An isolated human mahoganoid polypeptide comprising amino
acids the sequence of which is set forth in SEQ ID NO:8
Inventor
Wendy Chung (Columbia)
227
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228
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Individual Plaintiffs Each Plaintiff's isolated-sequence patents are unenforceable
because each Plaintiff failed to disclose to the USPTO that
they believe isolated sequences to be non-statutory subject-
matter
229
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Infectious Unenforceability • 37 CFR 1.56(c): "Every other person who is substantively
involved in the preparation or prosecution of the application
and who is associated . . . with the assignee."
230
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Infectious Unenforceability • 37 CFR 1.56(c): "Every other person who is substantively
involved in the preparation or prosecution of the application
and who is associated . . . with the assignee."
• Faculty assign their patents to their respective academic
institutions
231
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Infectious Unenforceability • 37 CFR 1.56(c): "Every other person who is substantively
involved in the preparation or prosecution of the application
and who is associated . . . with the assignee."
• Faculty assign their patents to their respective academic
institutions
• The individuals in the Technology Transfer Office (TTO) of
the academic institutions are typically involved in the
prosecution of patents for their faculty
232
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UPenn Technology Transfer Office (TTO)
Personnel
233
• Michael J. Cleare, Ph.D., Assoc.
Vice Provost for Research and Exec.
Director
• John S. Swartley, Ph.D., Deputy
Executive Director
• Shilpa Bhansali, Ph.D., Associate
Director
• James W. Bowen, Ph.D., Assistant
Director
• Man Liang, Ph.D., Licensing Officer
• Lauren Miller, Ph.D., Associate
Director
• Robert H. Schenkel, Ph.D., Director
• Heather A. Steinman, Ph.D., Senior
Associate Director
• Pamela Beatrice, Ph.D., Associate
Director
• Thomas P. Fitzsimons, Director
• Erli Chen, Ph.D., Director
• Jennifer Langenberger, Director
• Michelle McSorley, Assistant
Director
• Nina Burnaford, Esq., Senior
Associate Director
• Kathryn A. Donohue, Esq., Director
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Yale TTO Personnel • Jon Soderstrom - Managing Director, Office of Cooperative Research
• John W. Puziss - Director of Licensing
• David A. Lewin - Senior Associate Director, Medical Campus
• Hong Peng - Associate Director, Medical Campus
• Christopher Unsworth- Associate Director, Medical Campus
• Bill Wiesler - Director of New Ventures
• Kimberly Muller - Associate Director, Central Campus
• Thomas E. Shrader - Director of Strategic Corporate Partnerships
• Diane K. Harmon - Director of Intellectual Property Administration
• James G. Boyle - Director of Yale Entrepreneurial Institute (YEI)
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Columbia TTO Personnel
235
• Orin Herskowitz- Executive Director + VP, Intellectual Property & Tech
Transfer
• Daniel Abraham- Director, Morningside + Lamont-Doherty
• Scot Hamilton- Senior Director
• David Lerner- Director, Venture Lab
• Donna See- Director, Strategic Initiatives
• Steve Trost- Senior Advisor
• Ofra Weinberger- Director, Health Sciences
• David LernerDirector, Venture Lab
• Andres SotoAssistant Director, Venture Lab
• Susan Roadfeldt (Assistant Director)
• Plus 21 other individuals
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NYU TTO Personnel
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• Abram Goldfinger, Executive Director, Industrial Liaison/Technology Transfer.
• Sadhana Chitale, Ph.D., Associate Director, Technology Transfer/Life Sciences.
• Robert J. Fechter, Associate Director, Information Technology Transfer.
• Jill Gold, Contracts Manager.
• Andrew Koopman, Manager, New Venture Development.
• Prajakta Sonalker, Ph.D., Intellectual Property Manager.
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Emory TTO Personnel • Todd Sherer, PhD – Assoc. VP for Research, Director
• Linda Kesselring, MBA – Director of Operations
• Susanne Hollinger, PhD, JD – Assoc. Director, Chief IP Officer
• Connie Newsome – Senior Program Assoc., Executive Assistant
• Kevin Lei, MS, MBA – Assoc. Director, VentureLab Director
• J. Cale Lennon, III, PhD, MBA – Assistant Director
• Chris Paschall, PhD – Licensing Assoc.
• Cory Acuff, PhD – Senior Licensing Assoc.
• Panya Taysavang, MBA – Licensing Assoc.
• Cliff Michaels, PhD – Licensing Assoc.
• Randi Isaacs, JD – Patent Counsel
• James Mason, MS, JD – Patent Counsel
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Infectious Unenforceability • The BRCA lawsuit is a very high profile case
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Infectious Unenforceability • The BRCA lawsuit is a very high profile case
• The TTO-personnel of Yale, Emory, UPenn, Columbia, and NYU are
likely aware of their own inventors' activities
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Infectious Unenforceability • The BRCA lawsuit is a very high profile case
• The TTO-personnel of Yale, Emory, UPenn, Columbia, and NYU are
likely aware of their own inventors' activities
• The TTO-personnel of Yale, Emory, UPenn, Columbia, and NYU are
aware of their own inventors' positions in the BRCA lawsuit
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Infectious Unenforceability • The BRCA lawsuit is a very high profile case
• The TTO-personnel of Yale, Emory, UPenn, Columbia, and NYU are
likely aware of their own inventors' activities
• The TTO-personnel of Yale, Emory, UPenn, Columbia, and NYU are
aware of their own inventors' positions in the BRCA lawsuit
• Several isolated-sequence-related claims were indeed invalidated (in
both the S.D.N.Y. and Fed. Cir.)
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Infectious Unenforceability • The BRCA lawsuit is a very high profile case
• The TTO-personnel of Yale, Emory, UPenn, Columbia, and NYU are
likely aware of their own inventors' activities
• The TTO-personnel of Yale, Emory, UPenn, Columbia, and NYU are
aware of their own inventors' positions in the BRCA lawsuit
• Several isolated-sequence-related claims were indeed invalidated (in
both the S.D.N.Y. and Fed. Cir.)
• Insofar as the isolated-sequence-related claims were invalidated for
being non-statutory subject matter, that information is "necessarily
material"
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Infectious Unenforceability • The TTO of Yale, Emory, UPenn, Columbia, and NYU had an
obligation to disclose the non-statutory nature of isolated sequences to
the USPTO
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Infectious Unenforceability • The TTO of Yale, Emory, UPenn, Columbia, and NYU had an
obligation to disclose the non-statutory nature of isolated sequences to
the USPTO
• IF TTO-PERSONNEL MADE A DELIBERATE DECISION TO
WITHHOLD THAT INFORMATION, then all isolated-sequence-
related patents from Yale, Emory, UPenn, Columbia, and NYU are
unenforceable for inequitable conduct
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Infectious Unenforceability • The TTO-personnel of Yale, Emory, UPenn, Columbia, and NYU did
not disclose the non-statutory nature of isolated sequences to the USPTO
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Infectious Unenforceability • The TTO-personnel of Yale, Emory, UPenn, Columbia, and NYU did
not disclose the non-statutory nature of isolated sequences to the USPTO
• All isolated-sequence patents from Yale, Emory, UPenn, Columbia, and
NYU are unenforceable for inequitable conduct
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Toledo Intellectual Property Law Association for inviting me to
speak
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Toledo Intellectual Property Law Association for inviting me to
speak
Those who will forgive me for stealing their image and
violating their rights of publicity
249
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The entire Han clan of Joshua
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The entire Han clan of Joshua, Clare
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The entire Han clan of Joshua, Clare, Cecilia
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The entire Han clan of Joshua, Clare, Cecilia, Catherine
254
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The entire Han clan of Joshua, Clare, Cecilia, Catherine, and Amy
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256