Ariad Pharm.S Inc v. Eli Lilly And Co.

Decision Date22 March 2010
Docket NumberNo. 2008-1248.,2008-1248.
Citation598 F.3d 1336
PartiesARIAD PHARMACEUTICALS, INC., Massachusetts Institute of Technology, The Whitehead Institute for Biomedical Research, and the President and Fellows of Harvard College, Plaintiffs-Appellees, v. ELI LILLY AND COMPANY, Defendant-Appellant.
CourtU.S. Court of Appeals — Federal Circuit

John M. Whealan, of Silver Spring, MD argued for plaintiffs-appellees. With him on the brief were James W. Dabney, Stephen S. Rabinowitz, and Randy C. Eisensmith, Fried Frank Harris Shriver & Jacobson LLP, of New York, NY, and John F. Duffy, of Washington, DC. Of counsel were Leora Ben-Ami, Patricia A. Carson Christopher T, Jagoe, Sr., Matthew McFarlane, and Howard S. Suh, Kaye Scholer LLP, of New York, NY.

Charles E. Lipsey, Finnegan Henderson, Farabow, Garrett & Dunner L.L.P., of Reston, VA, argued for defendant-appellant. With him on the brief were Robert D. Bajefsky, David S. Forman, Howard W. Levine, Laura P. Masurovsky, and Jennifer A. Johnson, of Washington, DC, and Jennifer S. Swan, of Palo Alto, CA. Of counsel on the brief were Paul R. Cantrell, Gilbert T. Voy, and Alexander Wilson, Eli Lilly and Company, of Indianapolis, IN. Of counsel was Sanya Sukduang, Finnegan, Henderson, Farabow, Garrett & Dunner, L.L.P., of Washington, DC.

Mark R. Freeman, Attorney, Appellate Staff, Civil Division, United States Department of Justice, of Washington, DC, argued for amicus curiae United States. With him on the brief were Ann Ravel, Acting Assistant Attorney General, and Scott R. Mcintosh, Attorney. Of counsel on the brief were James A. Toupin, General Counsel, and Raymond T. Chen, Solicitor, United States Patent and Trademark Office, of Arlington, VA.

Roberta J. Morris, of Menlo Park, CA, for amicus curiae Roberta J. Morris, Esq., Ph.D.

Kenneth J. Burchfiel, Sughrue Mion, PLLC, of Washington, DC, for amicus curiae Novozymes A/S. With him on the brief was John T. Callahan.

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

Mark D. Janis, Indiana University Maurer School of Law, of Bloomington, IN, for amici curiae Mark D. Janis and Timothy R. Holbrook.

Charles A. Weiss, Kenyon & Kenyon LLP, of New York, NY, for amicus curiae New York Intellectual Property Law Association. With him on the brief was Dale L. Carlson, Wiggin and Dana LLP, of New Haven, CT.

Lynn H. Pasahow, Fenwick & West LLP, of Mountain View, CA, for amici curiae The Regents of the University of California, et al. With him on the brief were Heather N. Mewes and Carolyn C. Chang. Of counsel on the brief was P. Martin Simpson, Jr., The Regents of the University of California, of Oakland, CA.

Charles Lee Thomason, Spalding & Thompson, of Bardstown, KY, for amici curiae The University of Kentucky Intellectual Property Law Society, et al.

Christopher A. Cotropia, Intellectual Property Institute, University of Rich mond Law School, of Richmond, VA, for Professor Christopher A. Cotropia.

Herbert C. Wamsley, Intellectual Property Owners Association, of Washington, DC, for amicus curiae Intellectual Property Owners Association. On the brief were Peter G. Pappas, William F. Long, and Elizabeth A. Lester, Sutherland Asbill & Brennan LLP, of Atlanta, GA, and Steven W. Miller and Richard F. Phillips, Intellectual Property Owners Association, of Washington, DC.

William P. Atkins, Pillsbury Winthrop Shaw Pittman LLP, of McLean, VA, for amicus curiae Medtronic, Inc. With him on the brief was Jack S. Barufka.

Oskar Liivak, Cornell Law School, of Ithaca, NY, for amicus curiae Oskar Liivak.

Robert F. Kramer, Howrey LLP, of San Francisco, CA, for amicus curiae RealNetworks, Inc. With him on the brief were David R. Stewart and Irene I. Yang.

James E. Brookshire, Federal Circuit Bar Association, of Washington, DC, for amicus curiae Federal Circuit Bar Association. With him on the brief were Edward R. Reines and Sonal N. Mehta, Weil, Gotshal & Manges LLP, of Redwood Shores, CA.

Walter Dellinger, O'Melveny & Myers LLP, of Washington, DC, for amicus curiae Hynix Semiconductor Inc. With him on the brief were Sri Srinivasan, Mark S. Davies, and Kathryn E. Tarbert; and Kenneth L. Nissly and Susan Roeder, of Menlo Park, CA. Of counsel on the brief were Theodore G. Brown, III and Julie J. Han, Townsend and Townsend and Crew LLP, of Palo Alto, CA. On the brief for amicus curiae Samsung Electronics Co., Ltd. was Matthew D. Powers, Weil Gotshal & Manges LLP, of Redwood Shores, CA. With him on the brief were Steven S. Cherensky; Robert S. Berezin, of New York, NY; and Carmen E. Bremer, of Dallas, TX.

R. Carl Moy, William Mitchell College of Law, of St. Paul, MN, for amicus curiae William Mitchell College of Law, Intellectual Property Institute. With him on the brief was Jay A. Erstling.

William F. Lee, Wilmer Cutler Pickering Hale and Dorr LLP, of Boston, MA, for amicus curiae Abbott Laboratories. With him on the brief were William G. McElwain, Randolph D. Moss, Amy K. Wigmore, and Thomas G. Saunders of Washington, DC. Of counsel on the brief were Eric P. Martin and Peter N. Witty, Abbott Laboratories, of Abbott Park, IL.

Nancy J. Linck, Rothwell, Figg, Ernst & Manbeck, P.C., of Washington, DC, for amicus curiae Monsanto Company. With her on the brief were Minaksi Bhatt and Martha Cassidy. Of counsel on the brief was Dennis R. Hoerner, Monsanto Company, of St. Louis, MO.

Sherry M. Knowles, GlaxoSmithKline, of King of Prussia, PA, for amicus curiae GlaxoSmithKline.

Constantine L. Trela, Jr., Sidley Austin LLP, of Chicago, IL, for amicus curiae Microsoft Corporation. With him on the brief were Richard A. Cederoth and Tacy F. Flint; and Jeffrey P. Kushan, of Washington, DC. Of counsel on the brief was Thomas Andrew Culbert, Microsoft Corporation, of Redmond, WA.

Richard A. Samp, Washington Legal Foundation, of Washington, DC, for amicus curiae Washington Legal Foundation. With him on the brief was Daniel J. Popeo.

Lloyd R. Day, Jr., Howrey LLP, of East Palo Alto, CA, for amicus curiae Amgen Inc. With him on the brief was Linda A. Sasaki-Baxley. Of counsel on the brief were Stuart L. Watt, Wendy A. Whiteford, Monique L. Cordray, and Gail A. Katz, Amgen Inc., of Thousand Oaks, CA.

Teresa Stanek Rea, Crowell & Moring LLP, of Washington, DC, for amicus curiae American Intellectual Property Law Association. Of counsel on the brief was Alan J. Kaspar, American Intellectual Property Law Association, of Arlington, VA.

Paul D. Clement, King & Spalding LLP, of Washington, DC, for amici curiae Google Inc., and Verizon Communications, Inc. With him on the brief were Erin E. Morrow and Scott T. Weingaertner, of New York, NY. Of counsel for Verizon Communications, Inc. was John Thorne, Verizon Communications, Inc., of Arlington, VA. Of counsel for Google Inc. was Michelle K. Lee, Google Inc., of Mountain View, CA. On the brief for amicus curiae Cisco Systems, Inc. was Louis Norwood Jameson, Duane Morris LLP, of Atlanta, GA.

Joshua D. Sarnoff, Glushko-Samuelson Intellectual Property Law Clinic, Washington College of Law, American University, of Washington, DC, for amicus curiae Public Patent Foundation.

Before MICHEL, Chief Judge, NEWMAN, MAYER, LOURIE, RADER, BRYSON, GAJARSA, LINN, DYK, PROST, and MOORE, Circuit Judges.

Opinion for the court filed by Circuit Judge LOURIE, in which Chief Judge MICHEL and Circuit Judges NEWMAN, MAYER, BRYSON, GAJARSA, DYK, PROST, and MOORE join. Additional views filed by Circuit Judge NEWMAN. Concurring opinion filed by Circuit Judge GAJARSA. Dissenting-in-part, concurring-in-part opinion filed by Circuit Judge RADER, in which Circuit Judge LINN joins. Dissenting-in-part, concurring-in-part opinion filed by Circuit Judge LINN, in which Circuit Judge RADER joins.

LOURIE, Circuit Judge.

Ariad Pharmaceuticals, Inc., Massachusetts Institute of Technology, the Whitehead Institute for Biomedical Research and the President and Fellows of Harvard College (collectively, "Ariad") brought suit against Eli Lilly & Company ("Lilly") in the United States District Court for the District of Massachusetts, alleging infringement of U.S. Patent 6, 410, 516 ("the '516 patent"). After trial, at which a jury found infringement, but found none of the asserted claims invalid, a panel of this court reversed the district court's denial of Lilly's motion for judgment as a matter of law ("JMOL") and held the asserted claims invalid for lack of written description. Ariad Pharms., Inc. v. Eli Lilly & Co., 560 F.3d 1366 (Fed.Cir.2009).

Ariad petitioned for rehearing en banc, challenging this court's interpretation of 35 U.S.C. § 112, first paragraph, as containing a separate written description requirement. Because of the importance of the issue, we granted Ariad's petition and directed the parties to address whether § 112, first paragraph, contains a written description requirement separate from the enablement requirement and, if so, the scope and purpose of that requirement. We now reaffirm that § 112, first paragraph, contains a written description requirement separate from enablement, and we again reverse the district court's denial of JMOL and hold the asserted claims of the '516 patent invalid for failure to meet the statutory written description requirement.

BACKGROUND

The '516 patent relates to the regulation of gene expression by the transcription factor NF-eB. The inventors of the '516 patent were the first to identify NF-eB and to uncover the mechanism by which NF-eB activates gene expression underlying the body's immune responses to infec tion. The inventors discovered that NFeB normally exists in cells as an inactive complex with a protein inhibitor, named "IeB" ("Inhibitor of kappa B"), and is activated by extracellular stimuli, such as bacterial-produced lipopolysaccha rides through a series of biochemical reactions that release it from IeB. Once free of its inhibitor, NF-eB travels into the cell nucleus where it binds to and activates the...

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