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2010-1406

United States Court of Appeals

for the Federal Circuit

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, PhD, WENDY CHUNG, MD, PhD, HARRY OSTRER, MD,

DAVID LEDBETTER, PhD, STEPHEN WARREN, PhD, 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 OF AMICI CURIAE AMERICAN MEDICAL ASSOCIATION, AMERICAN SOCIETY

OF HUMAN GENETICS, AMERICAN COLLEGE OF OBSTETRICIANS AND

GYNECOLOGISTS, AMERICAN OSTEOPATHIC ASSOCIATION, AMERICAN COLLEGE

OF LEGAL MEDICINE, AMERICAN COLLEGE OF EMBRYOLOGY, AND THE MEDICAL

SOCIETY OF THE STATE OF NEW YORK IN SUPPORT OF PLAINTIFFS-APPELLEES

June 15, 2012

PROFESSOR LORI B. ANDREWS

Counsel of Amici Curiae

IIT Chicago-Kent College of Law

565 West Adams Street

Chicago, IL 60661

(312) 906-5359

landrews@kentlaw.iit.edu

COUNSEL PRESS, LLC (202) 783-7288 * (888) 277-3259

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i

TABLE OF CONTENTS

TABLE OF AUTHORITIES.................................................................................. ii

STATEMENT OF INTEREST OF AMICI CURIAE........................................... 1

SUMMARY OF THE ARGUMENT...................................................................... 3

ARGUMENT............................................................................................................ 4

I. Section 101 Prohibits Patents on Laws of Nature and Products of Nature......... 4

A. Myriad’s Claims Must Be Analyzed Under Section 101 ........................... 5

B. Isolated DNA Is an Unpatentable Product of Nature ................................. 6

C. cDNA Is an Unpatentable Product of Nature ............................................. 7

D. The Method Described in Claim 20 Is Unpatentable Subject Matter........ 8

II. The United States Patent and Trademark Office Erred in Granting Gene

Sequence Patents and Its Erroneous Decision Should Not Be Given

Deference............................................................................................................. 9

III. Upholding Myriad’s Patent Claims Would Be a Detriment to Further

Innovation...............................................................................10

A. Myriad’s Contributions Do Not Justify the Threat to Innovation ............12

B. Invalidation of Myriad’s Patent Claims Is Not Only Required by Section

101, It Is Consistent with Scientific and Medical Ethics Codes..............14

CONCLUSION.......................................................................................................15