Post on 21-Mar-2021
Sam S. Han, Ph.D., J.D.
Assistant Professor of Law
University of Dayton
1
2
SAM HAN
3
SAM HAN
Slauson Middle School, Ann Arbor, MI
4
SAM HAN
Slauson Middle School, Ann Arbor, MI
1984
5
SAM HAN
Slauson Middle School, Ann Arbor, MI
1984
Pioneer High School, Ann Arbor, MI
6
SAM HAN
Slauson Middle School, Ann Arbor, MI
1984
Pioneer High School, Ann Arbor, MI
1988
7
SAM HAN
Slauson Middle School, Ann Arbor, MI
1984
Pioneer High School, Ann Arbor, MI
1988
University of Michigan, Ann Arbor, MI
8
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
11
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).
12
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).
13
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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?
15
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
19
GENES
basic unit of heredity in a
living organism
hold information to pass
genetic traits to offspring
20
GENES
basic unit of heredity in a
living organism
hold information to pass
genetic traits to offspring
correspond to many
different biological traits
21
GENES
basic unit of heredity in a
living organism
hold information to pass
genetic traits to offspring
correspond to many
different biological traits
22
GENES
basic unit of heredity in a
living organism
hold information to pass
genetic traits to offspring
correspond to many
different biological traits
23
GENES
basic unit of heredity in a
living organism
hold information to pass
genetic traits to offspring
correspond to many
different biological traits
24
GENES
basic unit of heredity in a
living organism
hold information to pass
genetic traits to offspring
correspond to many
different biological traits
25
GENES
basic unit of heredity in a
living organism
hold information to pass
genetic traits to offspring
correspond to many
different biological traits
26
GOOD GENES
GENES
basic unit of heredity in a
living organism
hold information to pass
genetic traits to offspring
correspond to many
different biological traits
27
GOOD GENES
GENES
basic unit of heredity in a
living organism
hold information to pass
genetic traits to offspring
correspond to many
different biological traits
29
BAD GENES
GENES
basic unit of heredity in a
living organism
hold information to pass
genetic traits to offspring
correspond to many
different biological traits
30
BAD GENES
GENES
31
GENES
Hold information to build and
maintain cells
32
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
35
GENES
Hold information to build and
maintain cells
Control basic biochemical
processes of life
Determine risk for specific
diseases
Including Breast Cancer
36
BRCA1
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
BREAST CANCER
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BRCA1
BRCA2
BREAST CANCER
U.S. Statistics
39
BRCA1
BRCA2
BREAST CANCER
U.S. Statistics
~216,000 cases
40
BRCA1
BRCA2
BREAST CANCER
U.S. Statistics
~216,000 cases
~40,000 deaths
41
BRCA1
BRCA2
BREAST CANCER
U.S. Statistics
~216,000 cases
~40,000 deaths
Worldwide Statistics
42
BRCA1
BRCA2
BREAST CANCER
U.S. Statistics
~216,000 cases
~40,000 deaths
Worldwide Statistics
second most common type of cancer
(after lung cancer)
43
BRCA1
BRCA2
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
44
BRCA1
BRCA2
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
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
BREAST CANCER
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BRCA1
BRCA2
BREAST CANCER
Other Relevant Statistics
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BRCA1
BRCA2
BREAST CANCER
Other Relevant Statistics
30-year old woman
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BRCA1
BRCA2
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
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
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
OVARIAN CANCER
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BRCA1
BRCA2
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
57
Items beyond the scope of this presentation
58
Items beyond the scope of this presentation
Detailed claim analysis for patents-in-suit
59
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)
64
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
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Exception
Laws of Nature
67
Exception
Laws of Nature
Natural Phenomenon
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Exception
Laws of Nature
Natural Phenomenon
Abstract Idea
69
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 . . . .”
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37 CFR 1.63: Oath or declaration.
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37 CFR 1.63: Oath or declaration. “[T]he oath or declaration must also:
73
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
Therasense v. Becton, Case No. 2008-1511 (Fed. Cir.
May 25, 2011)
Inequitable Conduct requires both:
Intent; and
Materiality.
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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.
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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
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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The National Center for Human Genome
Research (National Institutes of Health)
Players
81
The National Center for Human Genome
Research (National Institutes of Health)
Players
Bernadine Healy (+)
82
The National Center for Human Genome
Research (National Institutes of Health)
Players
Bernadine Healy (+)
James D. Watson (-)
83
The National Center for Human Genome
Research (National Institutes of Health)
Players
Bernadine Healy (+)
James D. Watson (-)
J. Craig Venter (+)
84
The National Center for Human Genome
Research (National Institutes of Health)
Players
Bernadine Healy (+)
James D. Watson (-)
J. Craig Venter (+)
Francis Collins (=)
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MARGARET B. COLLINS-HILL
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MARGARET B. COLLINS-HILL
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MARGARET B. COLLINS-HILL
Pioneer High School, Ann Arbor, MI
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MARGARET B. COLLINS-HILL
Pioneer High School, Ann Arbor, MI
1988
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MARGARET B. COLLINS-HILL
Pioneer High School, Ann Arbor, MI
1988
University of Michigan, Ann Arbor, MI
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MARGARET B. COLLINS-HILL
Pioneer High School, Ann Arbor, MI
1988
University of Michigan, Ann Arbor, MI
1992
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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
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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
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GENETIC EQUATION
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GENETIC EQUATION
+
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GENETIC EQUATION
+ =
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GENETIC EQUATION
+ =
Courtesy of <http://www.MorphThing.com>
98
The National Center for Human Genome
Research (National Institutes of Health)
Players
Bernadine Healy (+)
James D. Watson (-)
J. Craig Venter (+)
Francis Collins (=)
Timeline
99
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
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
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
103
Myriad's Patents
104
Myriad's Patents
Allegedly covering natural human genes
105
Myriad's Patents
Allegedly covering natural human genes
U.S. Patent Number 5,727,282
U.S. Patent Number 5,837,492
106
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
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
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
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
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
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
Myriad's Patents
113
Myriad's Patents
Co-Owners
114
Myriad's Patents
Co-Owners
Myriad Genetics (Delaware corporation; Utah presence)
115
Myriad's Patents
Co-Owners
Myriad Genetics (Delaware corporation; Utah presence)
University of Utah Research Foundation (Salt Lake City, Utah)
116
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
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
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)
119
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
120
121
The Events Leading Up to the Lawsuit
122
The Events Leading Up to the Lawsuit Myriad Genetics v. University of Pennsylvania, 2:98-cv-
00829 (D. Utah 1998)
123
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
124
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
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
126
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
127
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
Gene Patents and Genetic Research
Timeline
129
Gene Patents and Genetic Research
Timeline 1990: Human Genome Project begins
130
Gene Patents and Genetic Research
Timeline 1990: Human Genome Project begins
Under the direction of Dr. James D. Watson
131
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
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
133
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
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
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
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
137
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
138
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
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
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
142
The Plaintiffs
143
The Plaintiffs
Dr. Haig Kazazian
144
The Plaintiffs
Dr. Haig Kazazian
Professor of Molecular
Medicine in Genetics
145
The Plaintiffs
Dr. Haig Kazazian
Professor of Molecular
Medicine in Genetics
Department of Genetics
146
The Plaintiffs
Dr. Haig Kazazian
Professor of Molecular
Medicine in Genetics
Department of Genetics
University of Pennsylvania
School of Medicine
147
The Plaintiffs
Dr. Arupa Ganguly
148
The Plaintiffs
Dr. Arupa Ganguly
Associate Professor
149
The Plaintiffs
Dr. Arupa Ganguly
Associate Professor
Department of Genetics
150
The Plaintiffs
Dr. Arupa Ganguly
Associate Professor
Department of Genetics
Hospital of the University of
Pennsylvania
151
The Plaintiffs
Dr. Wendy Chung
152
The Plaintiffs
Dr. Wendy Chung
Associate Professor of
Pediatrics
153
The Plaintiffs
Dr. Wendy Chung
Associate Professor of
Pediatrics
Columbia University
154
The Plaintiffs
Drs. David Ledbetter and
Stephen Warren
155
The Plaintiffs
Drs. David Ledbetter and
Stephen Warren
Professors of Human
Genetics
156
The Plaintiffs
Drs. David Ledbetter and
Stephen Warren
Professors of Human
Genetics
Emory University
157
The Defendants
158
The Defendants
The United States Patent and
Trademark Office
159
The Defendants
The United States Patent and
Trademark Office
Myriad Genetics
160
The Defendants
The United States Patent and
Trademark Office
Myriad Genetics
Directors of the University
of Utah Research Foundation
161
The Venue
162
The Venue
The United States District
Court for the Southern
District of New York
163
The Allegations
164
The Allegations
35 USC § 101
165
The Allegations
35 USC § 101
Patents on genes should not be allowed
166
The Allegations
35 USC § 101
Patents on genes should not be allowed
Patents on natural mutations should not be allowed
167
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
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
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
The Allegations
Rationale for Plaintiffs' argument is equally
applicable to all isolated sequences (e.g.,
nucleotide, amino acid, peptide, or polypeptide
sequences)
171
Motions to Dismiss
172
Motions to Dismiss
USPTO
173
Motions to Dismiss
USPTO
Myriad
174
Motion for Summary
Judgment
175
Motion for Summary
Judgment
Plaintiffs
176
Motion for Summary
Judgment
Plaintiffs
Affidavits from Chung,
Ostrer, and Ledbetter
177
178
The Court’s Order
The Court’s Order
“Defendants’
motion to dismiss
the Complaint is
denied”
179
180
The Court’s Order
“Defendants’
motion to dismiss
the Complaint is
denied”
November 1, 2009
181
Plaintiffs and Their Institutional Affiliations
182
Plaintiffs and Their Institutional Affiliations
University of Pennsylvania
183
Plaintiffs and Their Institutional Affiliations
University of Pennsylvania
Dr. Kazazian
Dr. Ganguly
184
Plaintiffs and Their Institutional Affiliations
University of Pennsylvania
Dr. Kazazian
Dr. Ganguly
Columbia
185
Plaintiffs and Their Institutional Affiliations
University of Pennsylvania
Dr. Kazazian
Dr. Ganguly
Columbia
Dr. Chung
186
Plaintiffs and Their Institutional Affiliations
University of Pennsylvania
Dr. Kazazian
Dr. Ganguly
Columbia
Dr. Chung
New York University
187
Plaintiffs and Their Institutional Affiliations
University of Pennsylvania
Dr. Kazazian
Dr. Ganguly
Columbia
Dr. Chung
New York University
Dr. Ostrer
Prof. Reich
188
Plaintiffs and Their Institutional Affiliations
University of Pennsylvania
Dr. Kazazian
Dr. Ganguly
Columbia
Dr. Chung
New York University
Dr. Ostrer
Prof. Reich
189
Emory
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
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
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
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?
194
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
196
Issued Patents by Affiliate Institutions
197
Issued Patents by Affiliate Institutions
University of Pennsylvania
At least 74 patents on isolated sequences
198
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
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
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
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
Patent Applications by Affiliate Institutions
203
Patent Applications by Affiliate Institutions
University of Pennsylvania
At least 31 published applications on isolated sequences
204
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
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
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
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
Other Miscellaneous Items
209
Other Miscellaneous Items
U.S. Patent Application Number 10/216,122
210
Other Miscellaneous Items
U.S. Patent Application Number 10/216,122
Claim 5
211
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
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
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
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
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
Other Miscellaneous Items
U.S. Patent Application Number 10/216,122
Oath (or Declaration)
Signatures
217
Other Miscellaneous Items
U.S. Patent Number 5,874,212
218
Other Miscellaneous Items
U.S. Patent Number 5,874,212
Field of Invention
219
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
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
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
Other Miscellaneous Items
U.S. Patent Number 7,339,028
223
Other Miscellaneous Items
U.S. Patent Number 7,339,028
Claim 1
224
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
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
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
228
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
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
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
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
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
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)
234
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
NYU TTO Personnel
236
• 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.
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
237
Infectious Unenforceability • The BRCA lawsuit is a very high profile case
238
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
239
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
240
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.)
241
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"
242
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
243
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
244
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
245
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
246
247
Toledo Intellectual Property Law Association for inviting me to
speak
248
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
The entire Han clan of Joshua
251
The entire Han clan of Joshua, Clare
252
The entire Han clan of Joshua, Clare, Cecilia
253
The entire Han clan of Joshua, Clare, Cecilia, Catherine
254
The entire Han clan of Joshua, Clare, Cecilia, Catherine, and Amy
255
256