Wednesday, July 18, 2012

Watson Amicus Brief FC Myriad Hearing of July 20, 2012


UNITED STATES COURT OF APPEALS FOR THE FEDERAL CIRCUIT


2010-1406

THE ASSOCIATION FOR MOLECULAR PATHOLOGY, THE AMERICAN COLLEGE OF
MEDICAL GENETICS, THE AMERICAN SOCIETY FOR CLINICAL PATHOLOGY, THE
COLLEGE OF AMERICAN PATHOLOGISTS, HAIG KAZAZIAN, MD, ARUPA
GANGULY, Ph.D, WENDY CHUNG, MD, Ph.D, HARRY OSTRER, MD, DAVID
LEDBETTER, Ph.D, STEPHEN WARREN, Ph.D, ELLEN MATLOFF, M.S., ELSA REICH,
M.S., BREAST CANCER ACTION, BOSTON WOMEN�S HEALTH BOOK COLLECTIVE,
LISBETH CERIANI, RUNI LIMARY, GENAE GIRARD, PATRICE FORTUNE, VICKY
THOMASON, and KATHLEEN RAKER,


Plaintiffs-Appellees,

v.
UNITED STATES PATENT AND TRADEMARK OFFICE,

Defendant,

and

MYRIAD GENETICS, INC.,

Defendant-Appellant,

and


LORRIS BETZ, ROGER BOYER, JACK BRITTAIN, ARNOLD B. COMBE, RAYMOND
GESTELAND, JAMES U. JENSEN, JOHN KENDALL MORRIS, THOMAS PARKS, DAVID
W. PERSHING, and MICHAEL K. YOUNG, in their official capacity as Directors of the
University of Utah Research Foundation,


Defendants-Appellants.

Appeal from the United States District Court for the Southern District of
New York, in case no. 09-CV-4515, Senior Judge Robert W. Sweet


BRIEF FOR AMICUS CURIAE JAMES D. WATSON
IN SUPPORT OF NEITHER PARTY


Matthew J. Dowd
James H. Wallace, Jr.
WILEY REIN LLP
1776 K Street NW
Washington, DC 20006

(202) 719-7000
Attorneys for Amicus Curiae James D. Watson

TABLE OF CONTENTS
Page

INTEREST OF AMICUS CURIAE JAMES D. WATSON .....................................1
ARGUMENT .............................................................................................................2


I.
BECAUSE HUMAN GENES ARE UNIQUE AND CONVEY
INFORMATION ABOUT THE ESSENCE OF BEING HUMAN,
THEY SHOULD NOT BE PATENTED ........................................................2
II.
THE HUMAN GENOME PROJECT WAS INTENDED TO
BENEFIT ALL, NOT JUST SELECT COMPANIES....................................8
III.
PATENTS ON HUMAN GENES ARE NOT NECESSARY, BUT IF
THEY ARE GRANTED, COMPULSORY LICENSES SHOULD BE
REQUIRED TO ENSURE FAIR ACCESS..................................................12
IV.
RULE 29(c)(5) STATEMENT......................................................................15
V.
CONCLUSION..............................................................................................15
CERTIFICATE OF SERVICE

TABLE OF AUTHORITIES


Page

Buck v. Bell,
274 U.S. 200 (1927)..............................................................................................6

OTHER SOURCES

Alok Jha, Human Genome Project Leader Warns Against Attempts to Patent
Genes, The Guardian, June 24, 2010 .................................................................13

James D. Watson, The Double Helix (1968).............................................................1


Tom Walsh, et al., Detection of Inherited Mutations for Breast and Ovarian
Cancer Using Genomic Capture and Massively Parallel Sequencing, 107
Proceedings of the National Academy of Science USA 12,629 (2010).............13

James D. Watson, The Nobelist vs. The Film Star: DNA Restrictions
Attacked, Washington Post, May 14, 1978, at D1................................................8

James D. Watson, DNA: The Secret of Life (2003)..........................................11, 15


J.D. Watson & F.H.C. Crick,
A Structure for Dexoyribose Nucleic Acid, 171 Nature 737 (1953).....................3
James D. Watson & John Tooze,
The DNA Story: A Documentary History of Gene Cloning (1981) ....................7

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INTEREST OF AMICUS CURIAE JAMES D. WATSON


James D. Watson is the co-discoverer of the double helix structure of
deoxyribonucleic acid (�DNA�). For this discovery, he and his colleague, the late
Francis Crick (along with the late Maurice Wilkins for related work), were
awarded the Nobel Prize in Physiology or Medicine in 1962. See James D.
Watson, The Double Helix (1968).

Throughout his career, Dr. Watson has been at the forefront of recombinant
DNA research and advances in genetic engineering. From 1956 until 1976, Dr.
Watson was on the faculty of Harvard University, leading the effort to focus the
biology department on the then-emerging field of molecular biology. Starting in
1968, Dr. Watson was the director of Cold Spring Harbor Laboratory (�CSHL�).
From 1994 to 2004, he served as the president of CSHL, and from 2004 until 2007,
he was CSHL�s chancellor. Dr. Watson is now Chancellor Emeritus of CSHL.

Of particular pertinence to the present appeal is Dr. Watson�s role in the
Human Genome Project. In 1988, Dr. Watson was appointed Associate Director
for Human Genome Research of the National Institutes of Health (�NIH�) and, in
1989, Director of the National Center for Human Genome Research at the NIH. In
these positions, Dr. Watson lead the public effort to sequence the human genome.

Given the significance of the issue at hand, Dr. Watson wishes to write
directly to the Court.

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ARGUMENT


I. BECAUSE HUMAN GENES ARE UNIQUE AND CONVEY
INFORMATION ABOUT THE ESSENCE OF BEING HUMAN,

THEY SHOULD NOT BE PATENTED

I have read through the various opinions issued in this case.1 Although the
opinions admirably describe the scientific details of DNA and human genes, what
the Court misses, I fear, is the fundamentally unique nature of the human gene.
Simply put, no other molecule can store the information necessary to create and
propagate life the way DNA does. It is a chemical entity, but DNA�s importance
flows from its ability to encode and transmit the instructions for creating humans.
Life�s instructions ought not be controlled by legal monopolies created at the whim
of Congress or the courts.

Even before DNA�s structure was revealed, many scientists recognized the
importance of a cell�s chromosomes (which are composed of DNA) to the
propagation of life. In 1944, Erwin Schrレdinger, a Nobel Prize-winning physicist,
wrote a small book titled What Is Life? In it, he reasoned that chromosomes were
the genetic information bearers. Schrレdinger thought that, because so much
information must be packed into every cell, the information must be compressed
into �hereditary code-script� embedded in the molecular fabric of the

1 I have also read the Supreme Court�s decision in Mayo v. Prometheus, although
its opaqueness must leave many attorneys wondering if it adds anything at all to
the issue of whether human genes ought to be patented.

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chromosomes. At the time, this was an untested hypothesis; most biologists
thought that proteins would be identified as the bearers of genetic instruction.
Eventually, chemical techniques advanced, and scientists confirmed that the
chromosomes contained our genes.

As it turned out, the secret to DNA�s ability to create life is its double helical
structure, along with its information-coding sequences. Francis Crick and I
published the first correct structure of DNA in 1953. J.D. Watson & F.H.C. Crick,
A Structure for Dexoyribose Nucleic Acid, 171 Nature 737 (1953).2 The double-
helical structure epitomized elegance in simplicity. From a chemical perspective,
DNA is little more than two strands of a nucleotide polymer wound together in a
double helix formation. The nucleotide polymer consists of various sequences of
A, T, G, and C bases. The helical structure has two strands, one complementary to
the other.

As soon as Francis and I deciphered the structure, we immediately
understood its significance. With a hint of more to come, we wrote in our article
that �[i]t has not escaped our notice that the specific pairing we have postulated
immediately suggests a possible copying mechanism for the genetic material.�
The double helix structure confirmed DNA�s role as the genetic carrier and created

2 At the time, we were in a tight race with Linus Pauling (soon to be a Nobel
laureate in chemistry). Fortunately for us, Pauling concluded that DNA was a
triple helix�an erroneous conclusion ironically based on a chemical error.

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the possibility of almost limitless information storage. The various sequences of
bases could be translated by a cell�s machinery, and that information would be
used to create new proteins for the cell.3

Later scientists discovered that certain DNA sequences controlled the
expression of other genes. One of the earliest discovered of these control
sequences was the �TATA box.� The TATA box contains the core DNA sequence
5�-TATAAA-3� or a similar variant. Specific proteins can bind to this sequence,
which promotes the transcription of other specific genes. Extracted from the
chromosome, a nucleic acid molecule having the TATAAA sequence has little,
physically inherent value. Its significance arises because that sequence is useful
information to the cell�s genetic machinery. The TATAAA sequence leads to the
expression of genes that affect the cell and ultimately our human experience.

The terminology of DNA underscores DNA�s informational role in life. In a
living cell, DNA is used to make RNA, and then RNA is used to make
polypeptides, i.e., protein. The first step�DNA to RNA�is called transcription.
The second step�RNA to proteins�is called translation. Both words connote the
conveyance of information. The information encoded by a human gene is first

3 Amusingly, after I gave my first presentation of our DNA structure in June 1953,
Leラ Szilヌrd, the Hungarian physicist and inventor of the nuclear chain reaction,
asked whether I would patent the structure. That, of course, was out of the
question.

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transcribed into RNA (DNA and RNA are similar molecules, thus similar
languages, so the genetic information is merely transcribed from one format to
another). Then, the genetic information is translated from RNA into protein.
(RNA and protein are different biochemical �languages,� hence translation). The
entirety of the DNA machinery focuses on transferring and utilizing the genetic
information.

When cells replicate, they make copies of the genetic code for the progeny
cells. New strands of DNA are synthesized in a process analogous to the way
scriveners of years past would copy legal documents. Just as scriveners would
copy legal documents word by word, a cell copies the DNA molecule letter by
letter (A, G, T, or C). And just as scriveners proofread their work, the DNA
polymerase�the enzyme that replicates DNA�has a built-in proofreading
mechanism. But as with all proofreading, the system is not perfect, and errors
occur. �Typographical� errors with DNA replication can lead to genetic
mutations�which can cause devastating diseases or can lead to evolutionary
improvements.

To this day, we continue to learn how human genes function. We estimate
that humans have approximately 22,000 genes. We have yet to fully understand
the functions of all human genes, but this lack of understanding is further reason

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that scientists should be permitted to experiment on human genes free from any
threat of patent infringement.

The social history of human genes also reveals DNA�s informational
uniqueness. In the early part of the twentieth century, many in society believed
that the answers to all of society�s ills resided in the human genome. From that
belief grew the eugenics movement�an ill-fated movement founded on an
incomplete understanding of genetics.

Even the legendary Supreme Court justice Oliver Wendell Holmes
misunderstood the role of genes in human development. In the landmark case of
Buck v. Bell, 274 U.S. 200, 207 (1927), Justice Holmes expressed a view about
genetics that prevailed during his time:

It is better for all the world, if instead of waiting to execute degenerate
offspring for crime, or to let them starve for their imbecility, society
can prevent those who are manifestly unfit from continuing their
kind. . . . Three generations of imbeciles are enough.

We now know that many factors affect a person�s mental acuity, genes being some
of them. But Justice Holmes and other supporters of the eugenics movement could
not appreciate, at that time, the precise role of the human gene.

In years to come, with the right advances in genetic engineering, we may
well be able to treat or rectify mental disabilities and physical diseases which today
are deemed incurable. Such hope is all the more reason that scientific research on
human genes should not be impeded by the existence of unnecessary patents.

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More importantly, we would not want one individual or company to monopolize
the legal right to the beneficial information of a human gene�information that
should be used for the betterment of the human race as a whole.

By the 1970s, the public�s perception of DNA had reached its nadir. Far
from being viewed as the vindicator of the wrongfully accused�as the public sees
it today�recombinant DNA technology was considered by many to be inherently
dangerous. Indeed, various interest groups wanted to ban recombinant DNA
research.4 Ironically, this hysteria seemed to begin after I participated in the first
scientific discussions exploring whether proposed regulations on DNA research
were necessary (at the Gordon Research Conference of Nucleic Acids in June
1973). Unfortunately, the initial ruminations mutated into full-fledged proposed
restrictions, issued from the Asilomar Conference in February 1974. Later, as the
hysteria increased, the National Institutes of Health (�NIH�) enacted regulations
governing recombinant DNA technology. The public discourse reached such a
fevered pitch that, in the summer of 1976, the Cambridge City Council declared a
three-month moratorium on recombinant DNA research in the city of Cambridge�
and therefore at Harvard University and the Massachusetts Institute of Technology.

4 I describe much of this history in one of my books. See James D. Watson & John
Tooze, The DNA Story: A Documentary History of Gene Cloning (1981).

-7 -


I, of course, did not favor these restrictions. At one point, I had to defend
recombinant DNA research from the attacks of the actor Robert Redford, who,
along with the Environmental Defense Fund, raised money to stop experiments
with recombinant DNA. See James D. Watson, The Nobelist vs. The Film Star:
DNA Restrictions Attacked, Washington Post, May 14, 1978, at D1. Eventually,
reason and objectivity prevailed, and scientists were free to conduct their
recombinant DNA research without absurd regulations.

My point with this overly brief and incomplete history of recombinant DNA
research is to illustrate how the major controversies associated with human genes
have arisen because human genes are much more than chemical compounds. The
myopic viewpoint thinks of a human gene as merely another chemical compound,
composed of various bases and sugars. But history and science teach us otherwise.
A human gene, which is a product of nature, is useful because it conveys vital
information. The human genome�s ability to be our instruction book on life
distinguishes it from other chemicals covered by the patent laws. No other
molecule carries the information to instruct a human zygote to become a boy or a
girl, a blonde or brunette, an Asian, African, or Caucasian.

II.
THE HUMAN GENOME PROJECT WAS INTENDED TO BENEFIT
ALL, NOT JUST SELECT COMPANIES
In addition to understanding the uniqueness of human DNA, I hope that an
awareness of the Human Genome Project�s history will guide the Court to the

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correct decision that human genes, as products of nature, should not be patented.
The Human Genome Project was started not to increase the profits of select
companies but to expand the our understanding of the human genome and make
this information available to all scientists.

The genesis of the Human Genome Project dates to the mid-1980s, when the
dual technological advances of recombinant DNA and computers opened the door
to deciphering the human genome. In June 1986, I organized a special session at
Cold Spring Harbor Laboratory to discuss the beginnings of what would become
the Human Genome Project. At that time, the U.S. Department of Energy had also
begun to focus on sequencing the genome. Other eminent scientists joined the
early effort, including Bruce Alberts, Sydney Brenner, and David Botstein.
Eventually, we published our report (from the National Academy of Sciences)
making the case for sequencing the human genome. With the support of James
Wyngaarden, then-head of NIH, and many others, the Human Genome Project
became reality.

In May 1988, I was appointed Associate Director for Human Genome
Research of NIH (and later, in 1989, became NIH�s Director of the National Center
for Human Genome Research). In these positions, my role was to oversee a
multimillion dollar budget and to organize what had become an international effort
to map the human genome. The United States was directing the project and carried

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out half of the work, while the rest was done mainly in the United Kingdom,
France, Germany, and Japan.

Even at the early stages of the project, we were concerned about the issue of
patenting human genes. Most, although not all, eminent scientists recognized that
human genes should not be monopolized by patents. I believed at the time�and
continue to believe�that the issue of patenting human genes went to the very crux
of whether the information encoded by human DNA should be freely available to
the scientific community. Some twenty years ago, I explained that patenting
human genes was lunacy, and I was not a lone voice.

Sadly, and to the detriment of scientific research, my view did not control
the policy decisions of NIH, which had filed for numerous patents covering human
genes. Even more egregious were the types of patents being filed on human genes.
Many of NIH�s patents described only small portions of a gene. For example, in
June 1991, an NIH official had urged Craig Venter, who at the time was working at
NIH, to file patent applications on several hundred new DNA sequences, even
though, in many instances, neither Venter nor NIH had any inkling of what those
sequences did. The following year, Venter listed over 2,000 more sequences in his
patent applications, still having no clue about the function of those sequences.

I expressed my objections to NIH management, but to no avail. To me, it
was clear that the goal of the Human Genome Project was to map and publish the

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human genome sequence for the scientific community. As the then-leader of the
project, I felt a particular obligation to do what I could. In my view,

[t]he Human Genome Project is much more than a vast roll call of As,

Ts, Gs, and Cs: it is as precious a body of knowledge as humankind

will ever acquire, with a potential to speak to our most basic

philosophical questions about human nature, for purposes of good and

mischief alike.
James D. Watson, DNA: The Secret of Life 172 (2003). In 1992, I publicly
opposed NIH�s decision to patent human genes. As a result, I was left with no
choice and was forced to resign from NIH that year. Patenting human genes was
not necessary to complete the Human Genome Project. Indeed, the international
effort was proceeding on schedule without any need to file patent applications on
human genes.

Less than fifteen years after its start, the Human Genome Project, along with
Celera Genomics, achieved success. On June 26, 2000, President Bill Clinton and
Prime Minister Tony Blair announced that the two groups had finished a working
draft, which was published for the public in February 2001. Gaps in the rough
draft were filled in by 2003�fifty years after Crick and I published the structure of
DNA. Scientists have used the data to estimate that humans have about 22,000
genes�in some sense a surprisingly small number compared to other organisms.

The Human Genome Project was a multi-agency, international effort. It was
funded in large part by taxpayer money, and the primary expectation was that the

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information derived from the sequenced human genes would be available for all
scientists to use. Unfortunately, a decade later, private companies are still trying to
unnecessarily restrict access to human genes and the information encoded in those
genes. This situation burdens all of society. Other scientists involved in the
Human Genome Project continue to warn about the harms caused by patenting
human genes. For instance, John Sulston, who received the 2002 Nobel Prize in
Physiology or Medicine, headed the British effort of the Human Genome Project.
He has explained that �many human genes have patent rights on them and this is
going to get in the way of treatment unless you have a lot of money.�5

III.
PATENTS ON HUMAN GENES ARE NOT NECESSARY, BUT IF
THEY ARE GRANTED, COMPULSORY LICENSES SHOULD BE
REQUIRED TO ENSURE FAIR ACCESS
As a third point, lawyers and judges misunderstand scientific research when
they contend that patent protection is necessary to encourage scientists to discover
human genes. A scientist does not�and should not�expect to obtain a legal
monopoly controlling the information encoded by human genes. And the average
scientist should not expect a windfall simply for revealing the sequence of DNA
bases that encode various genes. Research on human genes is one of those rare
endeavors which should be�and is done�with the understanding that, although

5 See Alok Jha, Human Genome Project Leader Warns Against Attempts to Patent
Genes, The Guardian, June 24, 2010, at http://www.guardian.co.uk/science/2010/
jun/24/human-genome-project-patent-genes.

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inventions based on those genes may later be commercialized, the genes
themselves are to be employed for the maximum benefits of humankind.

Consider also whether a biotechnology or pharmaceutical company derives
major revenue of human genes. From what I have seen, the answer is generally no.
Most biotechnology and pharmaceutical companies do not derive substantial
revenue from selling or licensing human genes. Rather, their primary revenue
source is much more likely their selling pharmaceuticals or actual research tools.
We should not be overly concerned that banning patents on human genes will
cause a detrimental loss of revenue.

Additionally, researchers are developing new medical diagnostic tools which
often rely on the use of multiple genes. For instance, investigators at the
University of Washington have developed parallel gene sequencing methods for
identifying of inherited mutations in breast and ovarian cancer genes. See Tom
Walsh, et al., Detection of Inherited Mutations for Breast and Ovarian Cancer
Using Genomic Capture and Massively Parallel Sequencing, 107 Proceedings of
the National Academy of Science USA 12,629 (2010). This group�s approach uses
multiple genes, not just the specific BRCA1 and BRCA2 genes in the Myriad
patents, to estimate cancer risk.

If each of the human genes used in a new multi-gene assay are subject to
patents, I fear that useful tests requiring multiple human genes will be

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unnecessarily delayed, become prohibitively expensive, or, worse yet, never be
made available to patients at all. For a new assay using hundreds of human genes,
the sea of patents and patent applications would create hundreds, if not thousands,
of individual obstacles to developing and commercializing the assay. The best
way, in my view, to resolve this problem is to eliminate the unnecessary patenting
of human genes.

If, for some reason, patents on human genes are deemed necessary, the next
best, albeit imperfect, solution is to require those patent holders to license the
patents to other researchers so that scientific progress is not obstructed. This is
often called a �compulsory license.� In my view, a compulsory license can
establish reasonable access to human genes and genetic information�which is
what scientists in general want, had the lawyers and courts not complicated
matters. Reasonable access facilitates scientific and social progress.

Compulsory licensing ensures that scientists and researchers will have
reasonable access to human genes and genetic information. Compulsory licensing
will attenuate the negative consequences of the genetic monopolies created by
patents. Implementing a compulsory license protocol will also reduce the risk that
a patient is denied access to life-saving medicines and technologies using human
genes and the information encoded in the genes.

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CERTIFICATE OF SERVICE

I hereby certify that on this day, June 15, 2012, two copies of the foregoing
BRIEF OF AMICUS CURIAE JAMES D. WATSON IN SUPPORT OF
NEITHER PARTY were served via first class mail on the following counsel for

the parties:

Gregory A. Castanias
Jones Day
51 Louisiana Avenue, N.W.
Washington, D.C. 20001

Counsel for Defendants-Appellants

Bruce Vignery
AARP Foundation Litigation
601 E Street, NW
Washington, DC 20049

Counsel for Amicus AARP

Barbara R. Rudolph
Finnegan, Henderson, Farabow,
Garrett & Dunner
901 New York Avenue, N.W.
Suite 1100
Washington, DC 20001-4413

Counsel for Amicus American
Intellectual Property Law
Association

Seth P. Waxman
Wilmer Hale
1875 Pennsylvania Avenue, N.W.
Washington, DC 20006

Counsel for Amici Biotech Industry
Organization et al.

Christopher A. Hansen
American Civil Liberties Union
125 Broad Street, 18th Floor
New York, New York 10004

Counsel for Plaintiffs-Appellees

Stephen B. Maebius
Foley and Lardner
3000 K Street, N.W., Suite 500
Washington, DC 20007

Counsel for Amicus Alnylam
Pharmaceuticals

Lori B. Andrews
Chicago-Kent College of Law
Illinois Institute of Technology
College of Law
565 West Adams Street
Chicago, IL 60661

Counsel for Amici American
Medical Association et al.

Erik P. Belt
McCarter & English
265 Franklin Street
Boston, MA 02110

Counsel for Amicus Boston Patent
Law Association

John L. Hendricks
Hitchcock Evert LLP
750 North St. Paul Street
Suite 1110
Dallas, Texas 75201

Counsel for Amici Canavan
Foundation et al.

Christopher M. Holman
5100 Rockhill Road
Kansas City, MO 64110

Counsel for Amici Christopher
Holman et al.

E. Richard Gold
Faculty of Law, McGill University
3664 Peel Street
Montreal, Quebec H3A 1W9
Counsel for Amici E. Richard Gold
et al.

Erika R. George
Loyola University Chicago School
of Law
25 E. Pearson
Chicago, IL 60611

Counsel for Amici Erika R. George and
Kali N. Murray

David S. Forman
Finnegan, Henderson, Farabow,
Garrett & Dunner
901 New York Avenue, N.W.
Washington, DC 20001-4413

Counsel for Amicus Genetic
Alliance

Larry Frierson
The Law Offices of Larry Frierson
3265 Lake County Highway
Calistoga, CA 94515

Counsel for Amici Cancer Council
Australia and Luigi Palombi

Jennifer Gordon
Baker Botts
30 Rockefeller Center
New York, NY 10112

Counsel for Amicus Croplife
International

Eileen M. Kane
Penn State Dickinson School of Law
328 Katz Building
University Park, PA 16802

Counsel for Amicus Professor
Eileen N. Kane

Maxim H. Waldbaum
Schiff Hardin
900 Third Avenue, 23rd Floor
New York, NY 10022

Counsel for Amicus Fホdホration
Internationale des Conseils en
Propriホtホ Industrielle (FICPI)

William G. Gaede, III
McDermott, Will & Emery
275 Middlefield Rd., Suite 100
Menlo Park, CA 94025

Counsel for Amici Genomic Health
et al.

J. Timothy Keane
Harness, Dickey & Pierce
7700 Bonhomme Avenue, Suite 400
St. Louis, MO 63105
Counsel for Amici Gilead Sciences
et al.

George Kimbrell
International Center for
Technology Assessment
660 Pennsylvania Ave., Suite 302
Washington, D.C. 20003

Counsel for Amici International
Center for Technology Assessment
et al.

Judy Deleon Jarecki-Black
Merial Limited
3239 Satellite Blvd.
Duluth, GA 30096

Counsel for Amicus Merial Limited

Debra L. Greenfield
UCLA Center for Society and
Genetics
Box 957221, 1323 Rolfe Hall
Los Angeles, CA 90095

Counsel for Amici National
Women�s Health Network et al.

Kurt G. Calia
Covington & Burling
1201 Pennsylvania Avenue, N.W.
Washington, DC 20004-2401

Counsel for Amicus Pharmaceutical
Research and Manufacturers of
America

Herbert C. Wamsley
Intellectual Property Owners
1501 M Street
Suite 1150
Washington, D.C. 20005

Counsel for Amicus Intellectual
Property Owners Association

Jacqueline Wright-Bonilla
Foley & Lardner LLP
3000 K Street, NW
Suite 500
Washington, D.C. 20007

Counsel for Amici Rosetta Genomics,
Inc. et al.

Kent D. McClure
Animal Health Institute
1325 G Street, NW, Suite 700
Washington, DC 20005

Counsel for Amicus Animal Health
Institute

Aaron Stiefel
Kaye Scholer
425 Park Avenue
New York, NY 10022

Counsel for Amicus Novartis Corp.

Mark R. Freeman

U.S. Department of Justice
950 Pennsylvania Avenue, N.W.
Room 7646
Washington, D.C. 20530
Counsel for Amicus Curiae United
States

Krista L. Cox Ann M. McCrackin
Universities Allied for Essential University of New Hampshire
Medicines 2 White Street
2625 Alcatraz Avenue Concord, NH 03301
No. 180 Counsel for Amicus University of New
Berkeley, CA 94705 Hampshire School of Law
Counsel for Amicus Universities Allied
for Essential Medicines

James J. Kelley Andrew Chin
Eli Lilly & Co. University of North Carolina School of
940 S. East Street Law
Dock 88 160 Ridge Road CB# 3380
Lilly Corp. Center � Drop Code 1104 Chapel Hill, NC 27599
Indianapolis, IN 46225 Counsel for Amici University of North
Counsel for Amicus Eli Lilly & Co. Carolina School of Law et al.

Francis Pizzulli
718 Wilshire Blvd.
Santa Monica, CA 90401

Counsel for Amicus The Southern
Baptist Convention

____________________
Matthew J. Dowd

Dated: June 15, 2012

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