The Ass'n For Molecular Pathology v. United States Patent

653 F.3d 1329

99 U.S.P.Q.2d 1398

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,andMyriad Genetics, Inc., Defendant–Appellant,andLorris 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.

No. 2010–1406.

United States Court of Appeals, Federal Circuit.

July 29, 2011.Rehearing Denied Sept. 13, 2011.Rehearing Denied Sept. 16, 2011.

Christopher A. Hansen, American Civil Liberties Union Foundation, of New York, NY, argued for plaintiffs-appellees. With him of the brief were Sandra S. Park, Aden Fine and Lenora M. Lapidus. Of counsel on the brief were Daniel B. Ravicher and Sabrina Y. Hassan, Benjamin N. Cardozo School of Law, of New York, NY.Gregory A. Castanias, Jones Day, of Washington, DC, argued for defendants-appellants. With him on the brief were Brian M. Poissant, Laura A. Coruzzi and Eileen Falvey, of New York, NY; and Israel Sasha Mayergoyz, of Chicago, IL. Of counsel were Benjamin Jackson and Jay Z. Zhang, Myriad Genetics, of Salt Lake City, UT.Mary M. Calkins, Foley & Lardner LLP, of Washington, DC, for amicus curiae Alnylam Pharmaceuticals, Inc. With her on the brief were Stephen B. Maebius and Harold C. Wegner. Of counsel on the brief was Donna T. Ward, DT Ward, P.C., Groton, MA.Christopher M. Holman, University of Missouri–Kansas City School of Law, Kansas City, MO, for amici curiae Christopher M. Holman and Robert Cook–Deegan.Paul H. Berghoff, McDonnell Boehnen Hulbert & Berghoff LLP, of Chicago, IL, for amicus curiae Intellectual Property Owners Association. With him on the brief were Kevin E. Noonan and Jeffrey P. Armstrong. Of counsel on the brief were Douglas K. Norman and Kevin H. Rhodes, Intellectual Property Owners Association, of Washington, DC.Barbara R. Rudolph, Finnegan, Henderson, Farabow, Garrett & Dunner, LLP, of Washington, DC, for amicus curiae American Intellectual Property Law Association. With her on the brief were Robert D. Litowitz and Erika Harmon Arner; and Robert C. Stanley, of Atlanta, GA. Of counsel on the brief was David W. Hill, American Intellectual Property Law Association, of Arlington, VA.Kent D. McClure, Animal Health Institute, of Washington, DC, for amicus curiae Animal Health Institute; Judy Jarecki–Black, Merial Limited, of Duluth, GA, for amicus curiae Merial Limited.Seth P. Waxman, Wilmer Cutler Pickering Hale and Dorr LLP, of Washington, DC, for amici curiae Biotechnology Industry Organization and the Association of University Technology Managers. With him on the brief were Thomas G. Saunders; Mark C. Fleming and Allen C. Nunnally, of Boston, MA. Of counsel on the brief was Hans Sauer, Biotechnology Industry Organization, of Washington, DC.Erik Paul Belt, McCarter & English, LLP, of Boston, MA, for amicus curiae Boston Patent Law Association. With him on the brief were Lee Carl Bromberg and Maria Laccotripe Zacharakis.Jennifer Gordon, Baker Botts, LLP, of New York, NY, for amicus curiae CropLife International. With her on the brief were Steven Lendaris and Jennifer C. Tempesta.Maxim H. Waldbaum, Schiff Hardin LLP, of New York, NY, for amicus curiae Federation Internationale Des Conseils en Propriete Industrielle.David S. Forman, Finnegan, Henderson, Farabow, Garrett & Dunner, LLP, of Washington, DC, for amicus curiae Genetic Alliance. With him on the brief were Charles T. Collins–Chase, Brenda J. Huneycutt, Jennifer A. Johnson, and Laura P. Masurovsky; Mukta Jhalani, of Palo Alto, CA; and Mary R. Henninger, of Atlanta, GA. Of counsel on the brief was Ann Waldo, Genetic Alliance, Inc., of Washington, DC.William G. Gaede, III, McDermott Will & Emery LLP, of Menlo Park, CA, for amici curiae Genomic Health, Inc., et al. With him on the brief was Andrew A. Kumamoto.Brian R. Dorn, Merchant & Gould, P.C., of Minneapolis, MN, for amicus curiae Kane Biotech Inc. With him on the brief was Katherine M. Kowalchyk.Aaron Stiefel, Kaye Scholer LLP, of New York, NY, for amicus curiae Novartis Corporation. Of counsel on the brief was Sylvia M. Becker, of Washington, DC.Kurt G. Calia, Covington & Burling, LLP, of Redwood Shores, CA, for amicus curiae Pharmaceutical Research and Manufacturers of America. Of counsel on the brief were Robert A. Long, Jr. and Allison E. Kerndt, of Washington, DC.Jacqueline D. Wright Bonilla, Foley & Lardner LLP, of Washington, DC, for amici curiae Rosetta Genomics, Ltd., et al. With her on the brief was Richard C. Peet. Of counsel on the brief was George C. Best, of Palo Alto, CA.Mark R. Freeman, Attorney, Appellate Staff, Civil Division, United States Department of Justice, of Washington, DC, for amicus curiae United States. With him on the brief were Tony West, Assistant Attorney General, Beth S. Brinkmann, Deputy Assistant Attorney General, and Scott R. McIntosh, Attorney.Ann M. McCrackin, University of New Hampshire School of Law, of Concord, NH, for amicus curiae University of New Hampshire School of Law. With her on the brief was J. Jeffrey Hawley.

J. Timothy Keane, Harness, Dickey & Pierce, P.L.C., of St. Louis, MO, for amici curiae Gilead Sciences, Inc., et al.Larry Frierson, the Law Offices of Larry Frierson, of Calistoga, CA, for amici curiae Cancer Council Australia and Luigi Palombi.Lori B. Andrews, Chicago–Kent College of Law, of Chicago, IL, for amici curiae American Medical Association, et al. With her on the brief was Joshua D. Sarnoff, DePaul University College of Law, of Chicago, IL.Eileen M. Kane, Penn State Dickinson School of Law, of University Park, PA, amicus curiae.James P. Evans, University of North Carolina, of Chapel Hill, NC, for amici curiae E. Richard Gold, James P. Evan and Tania Bubela. With him on the brief were E. Richard Gold, McGill University, of Montreal, Quebec, Canada; and Tania Bubela, University of Alberta, of Edmonton, Alberta, Canada.Erika R. George, Loyola University–Chicago School of Law, of Chicago, IL, for amici curiae Erika R. George and Kali N. Murray.Andrew Chin, University of North Carolina School of Law, of Chapel Hill, NC, for amicus curiae Professor Andrew Chin.Francis Pizzulli, of Santa Monica, CA, for amicus curiae the Southern Baptist Convention.John L. Hendricks, Hitchcock Evert LLP, of Dallas, TX, for amici curiae Canavan Foundation, et al. With him on the brief were Megan M. O'Laughlin and John T. Tower.George A. Kimbrell, the International Center for Technology Assessment, of Washington, DC, for amici curiae the International Center for Technology Assessment, et al.Krista L. Cox, Universities Allied for Essential Medicines, of Berkeley, CA, for amicus curiae Universities Allied for Essential Medicines.Bruce Vignery, AARP Foundation Litigation, of Washington, DC, for amicus curiae AARP. With him on the brief was Michael Schuster.Debra L. Greenfield, UCLA Center for Society and Genetics, of Los Angeles, CA, for amici curiae the National Women's Health Network, et al.Before LOURIE, BRYSON, and MOORE, Circuit Judges.Opinion for the court filed by Circuit Judge LOURIE. Opinion concurring in part filed by Circuit Judge MOORE. Opinion concurring in part and dissenting in part filed by Circuit Judge BRYSON.LOURIE, Circuit Judge.

Myriad Genetics, Inc. and the Directors of the University of Utah Research Foundation (collectively, “Myriad”) appeal from the decision of the United States District Court for the Southern District of New York holding that an assortment of medical organizations, researchers, genetic counselors, and patients (collectively, “Plaintiffs”) have standing under the Declaratory Judgment Act to challenge Myriad's patents. Assoc. for Molecular Pathology v. U.S. Patent & Trademark Office, 669 F.Supp.2d 365 (S.D.N.Y.2009) (“ DJ Op.”). Myriad also appeals from the district court's decision granting summary judgment that all of the challenged claims are drawn to non-patentable subject matter under 35 U.S.C. § 101. Assoc. for Molecular Pathology v. U.S. Patent & Trademark Office, 702 F.Supp.2d 181 (S.D.N.Y.2010) (“ SJ Op.”). We affirm in part and reverse in part.

On the threshold issue of jurisdiction, we affirm the district court's decision to exercise declaratory judgment jurisdiction because we conclude that at least one plaintiff, Dr. Harry Ostrer, has standing to challenge the validity of Myriad's patents. On the merits, we reverse the district court's decision that Myriad's composition claims to “isolated” DNA molecules cover patent-ineligible products of nature under § 101 since the molecules as claimed do not exist in nature. We also reverse the district court's decision that Myriad's method claim to screening potential cancer therapeutics via changes in cell growth rates is directed to a patent-ineligible scientific principle. We, however, affirm the court's decision that Myriad's method claims directed to “comparing” or “analyzing” DNA sequences are patent ineligible; such claims include no transformative steps and cover only patent-ineligible abstract, mental steps.

Background

Plaintiffs brought suit against Myriad, challenging the patentability of certain composition and method claims relating to human genetics. See DJ Op., at 369–76. Specifically, Plaintiffs sought a declaration that fifteen claims from seven patents assigned to Myriad are drawn to patent-ineligible subject matter under 35 U.S.C. § 101: claims 1, 2, 5, 6, 7,...