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Ariad Pharms., Inc. v. Eli Lilly & Co.

United States Court of Appeals for the Federal Circuit

March 22, 2010, Decided

2008-1248

Opinion

 [***1163]  [*1340]   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  [**8] 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 [***1164]  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-[K]B. The inventors of the '516 patent were the first  [**9] to identify NF-[K]B and to uncover the mechanism by which NF-[K]B activates gene expression underlying the body's immune responses to infection. The inventors discovered that NF-[K]B normally exists in cells as an inactive complex with a protein inhibitor, named "I[K]B" ("Inhibitor of kappa B"), and is activated by extracellular stimuli, such as bacterial-produced lipopolysaccharides, through a series of biochemical reactions that release it from I[K]B. Once free of its inhibitor, NF-[K]B travels into the cell nucleus where it binds to and activates the transcription of genes containing a NF-[K]B recognition site. The activated genes (e.g., certain cytokines), in turn help the body to counteract the extracellular assault. The production of cytokines can, however, be harmful in excess. Thus the inventors recognized that artificially interfering with NF-[K]B activity could reduce the harmful symptoms of certain diseases, and they filed a patent application on April 21, 1989, disclosing their discoveries and claiming methods for regulating cellular responses to external stimuli by reducing NF-[K]B activity in a cell.

Ariad brought suit against Lilly on June 25, 2002, the day the '516 patent  [**10] issued. Ariad alleged infringement of claims 80, 95, 144, and 145 by Lilly's Evista(R) and Xigris(R) pharmaceutical products. The asserted claims, rewritten to include the claims from which they depend, are as follows:

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598 F.3d 1336 *; 2010 U.S. App. LEXIS 5966 **; 94 U.S.P.Q.2D (BNA) 1161 ***

ARIAD 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.

Prior History:  [**1] Appeal from the United States District Court for the District of Massachusetts in Case No. 02-CV-11280, Judge Rya W. Zobel.

ARIAD Pharms., Inc. v. Eli Lilly & Co., 595 F.3d 1329, 332 Fed. Appx. 636, 2009 U.S. App. LEXIS 18981 (Fed. Cir., 2009)

Disposition:  The en banc court reaffirmed that 35 U.S.C. § 112, para. 1, contained a written description requirement separate from enablement, and again reversed the denial of the competitor's motion for judgment as a matter of law and held the asserted claims of the patent invalid for failure to meet the statutory written description requirement.

CORE TERMS

written description, invention, patent, specification, skilled, molecules, inventor, disclosure, original claim, genus, compound, first paragraph, disclose, invalid, cells, argues, asserted claim, recite, subject matter, exact terms, binding, concise, en banc, decoy, cases, enabled, generic, species, new matter, inhibitor

Governments, Legislation, Interpretation, Patent Law, Specifications, Description Requirement, Written Description Versus Enablement, General Overview, Courts, Judicial Precedent, Jurisdiction & Review, Standards of Review, US Patent & Trademark Office Proceedings, Examinations, Amendments & New Matter, Claim Broadening, Subject Matter, Standards & Tests, Infringement Actions, Claim Interpretation, Fact & Law Issues, Constitutional Law, Congressional Duties & Powers, Copyright & Patent Clause, Civil Procedure, Appeals, De Novo Review, Trials, Judgment as Matter of Law, Evidence, Burdens of Proof, Clear & Convincing Proof, Defenses, Patent Invalidity, Presumption of Validity, Inferences & Presumptions, Presumptions, Creation, Rebuttal of Presumptions, Substantial Evidence