Ass'n for Molecular Pathology v. U.S. Patent & Trademark Office

689 F.3d 1303

103 U.S.P.Q.2d 1681

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.

Aug. 16, 2012.

Christopher A. Hansen, American Civil Liberties Union Foundation, of New York, NY, argued for plaintiffs-appellees. With him on 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, Public Patent Foundation, Benjamin N. Cardozo, School of Law, of New York, NY.

Gregory A. Castanias, Jones Day, of Washington, DC, argued for all defendant-appellants. With him on the brief were Jennifer L. Swize, of Washington, DC, Israel Sasha Mayergoyz and Dennis Murashko, of Chicago, IL, Brian M. Poissant, Laura A. Coruzzi and Eileen Falvey, of New York, NY. Of counsel were Benjamin Jackson, and Jay Z. Zhang, Myriad Genetics, of Salt Lake City, UT.

Melissa N. Patterson, Attorney, Civil Division, Appellate Staff, United States Department of Justice, of Washington, DC, argued for amicus curiae, United States. With her on the brief were Stuart F. Delery, Acting Assistant Attorney General, Beth S. Brinkmann, Deputy Assistant Attorney General and Scott R. McItosh, Attorney. Of counsel was Mark R. Freeman.

Thomas J. Kowalski, Vedder Price PC, of New York, New York, for amicus curiae Protein Sciences Corporation. With him on the brief were Deborah L. Lu; and Robert S. Rigg, of Chicago, IL.

Robert A. Armitage, Eli Lilly and Company, Indianapolis, IN, for amicus curiae, Eli Lilly and Company. With him on the brief was James J. Kelley.

Christopher M. Holman, University of Missouri–Kansas City School of Law, of Kansas City, MO, for amicus curiae Law Professor Christopher M. Holman.

Charles R. Macedo, Amster Rothstein & Ebenstein, LLP, of New York, NY, for amicus curiae, New York Intellectual Property Law Association. Of counsel on the brief were Ronald M. Daignault and Matthew B. McFarlane, Robins, Kaplan, Miller & Ciresi, L.L.P. of New York, NY.

Lori B. Andrews, IIT Chicago–Kent College of Law, of Chicago, IL, for amicus curiae, The American College of Embryology, et al. Of counsel was Joshua D. Sarnoff, DePaul University College of Law, of Chicago, IL.

Debra L. Greenfield, UCLA Institute for Society and Genetics, of Los Angeles, CA, for amici curiae, The National Women's Health Network, et al.

Krista L. Cox, Knowledge Ecology International, of Washington, DC, for amicus curiae, Knowledge Ecology International, et al.

Richard F. Phillips, Intellectual Property Owners Association, of Washington, DC, for amicus curiae, Intellectual Property Owners Association. With him on the brief was Kevin H. Rhodes. Of counsel on the brief were Paul H. Berghoff, Kevin E. Noonan and Jeffrey P. Armstrong, McDonnell Boehnen Hulbert & Berghoff, LLP, of Chicago, IL. Of counsel were Herbert C. Wamsley, Intellectual Property Owners, of Washington, DC, and Douglas Kent Norman, Eli Lilly & Company, of Indianapolis, IN.

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, Erika Harmon Arner and David S. Forman. Of counsel on the brief was William G. Barber, American Intellectual Property Law Association, of Arlington, VA. Of counsel were David Warren Hill, American Intellectual Property, of Arlington, VA, and Robert C. Stanley, Finnegan, Henderson, Farabow, Garrett & Dunner, LLP, of Atlanta, GA.

William T. Robinson, III, American Bar Association, of Chicago, IL, for amicus curiae, American Bar Association. Of counsel on the brief were John P. Elwood, Vinson & Elkins, LLP, of Washington, DC; and Michael A. Valek, Stephen C. Stout, of Austin, TX.

Mark J. Gatschet, Mark John Gatschet, P.L.L.C., of Houston, TX, for amicus curiae, Mark J. Gatschet and Richard W. Knight. Of counsel on the brief was Richard W. Knight, R.W. Knight P.C. of San Antonio, TX.

Claire Laporte, Foley Hoag, LLP, of Boston, MA, for amicus curiae Federal Circuit Bar Association. With her on the brief was James M. Flaherty, Jr.

John L. Hendricks, Hitchcock Evert, LLP, of Dallas, TX, for amicus curiae, AARP, et al. With him on the brief were Megan M. O'Laughlin and John T. Tower. Of counsel was Michael R. Schuster.

J. Timothy Keane, Harness, Dickey & Pierce, PLC, of St. Louis, MO, for amicus curiae, BioGenerator, et al.

Susan E. McBee, Baker, Donelson, Bearman, Caldwell, and Berkowitz, P.C., of Washington, DC, for amicus curiae, Immatics Biotechnologie, GmbH. With her on the brief was Bryan W. Jones.

Seth P. Waxman, Wilmer Cutler Pickering Hale and Dorr, LLP, of Washington, DC, for amicus curiae, Biotechnology IndustryOrganization, et al. With him on the brief was Thomas G. Saunders. Of counsel on the brief was Mark C. Fleming, of Boston, MA, and Hansjorg Salter, Biotechnology Industry Organization, of Washington, DC. Of counsel was Allen C. Nunnally, Wilmer Cutler Pickering Hale and Dorr, LLP, of Boston, MA.

Jennifer Gordon, Baker Botts, L.L.P. of New York, NY, for amicus curiae, Croplife International. With her on the brief were Steven Lendaris and Jennifer C. Tempesta.

Matthew J. Dowd, Wiley Rein LLP, of Washington, DC, for amicus curiae, James D. Watson. With him on the brief was James H. Wallace, Jr.

Kurt G. Calia, Covington & Burling, LLP, of Redwood Shores, CA, for amicus curiae, Pharmaceutical Research and Manufacturers of America. With him on the brief were Robert A. Long, Jr. and Allison E. Kerndt, of Washington, DC, and Alexa R. Hansen, of San Francisco, CA.

Eileen M. Kane, Penn State Dickinson School of Law, of University Park, PA, for amicus curiae, Professor Eileen M. Kane.

Genevieve E. Scott, Yale School of Law, of Brooklyn, NY, for amicus curiae, Information Society Project at Yale Law School Scholars. With her on the brief was Priscilla J. Smith.

Robert Sachs, Fenwick & West, LLP, of San Francisco, CA, for amicus curiae, Advanced Biological Laboratories, SA.

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. Ass'n 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. Ass'n 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.

This appeal has returned to us as, a petition for certiorari having been filed from our decision of July 29, 2011, the Supreme Court of the United States granted the petition, vacated our decision, and remanded the case to us for further consideration in light of its decision in Mayo Collaborative Services v. Prometheus, Inc., 566 U.S. ––––, 132 S.Ct. 1289, 182 L.Ed.2d 321 (2012). Ass'n for Molecular Pathology v. Myriad Genetics, Inc., –––U.S. ––––, 132 S.Ct. 1794, 182 L.Ed.2d 613 (2012). We invited and received briefing by the parties and interested amici and held oral argument on July 20, 2012. Our decision on remand follows. It both decides the issues that were before us in the original appeal and evaluates the effect of Mayo on those issues.

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 because each of the claimed molecules represents a nonnaturally occurring composition of matter. We also reverse the district court's decision that Myriad's method claim to screening potential cancer therapeutics via changes in cell growth rates of transformed cells is directed to a patent-ineligible scientific principle. We affirm the court's decision, however, 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., 669 F.Supp.2d at 369–76. Specifically, Plaintiffs sought a declaration that fifteen claims from seven patents assigned to Myriad are drawn...