Not a Lexis Advance subscriber? Try it out for free.

Carnegie Mellon Univ. v. Hoffmann-La Roche Inc.

United States Court of Appeals for the Federal Circuit

September 8, 2008, Decided

2007-1266, 2007-1267

Opinion

 [***1234]   [*1117]  LOURIE, Circuit Judge.

Carnegie Mellon University ("CMU") and Three Rivers Biologicals, Inc. (collectively "appellants") appeal from the decision of the United States District Court for the Northern District of California holding that Hoffmann-La Roche, Inc., Roche Molecular Systems, Inc., Roche Diagnostic Systems, Inc., Roche Biomedical Laboratories, Inc., The Perkin Elmer Corporation, and Laboratory Corporation of America Holdings (collectively "Roche") do not infringe the patents in suit and that certain claims are invalid for lack of written description. Because we conclude that the district court  [**2] did not err in holding the claims invalid for failure to meet the written description requirement, we affirm the court's judgment of invalidity. Because we conclude that the court did not err in its infringement analysis, we affirm the court's judgment of noninfringement.

BACKGROUND

Proteins, one of the most versatile biomolecules, can serve many important roles, including as signal receptors, structural elements, or enzymes. They are encoded by particular deoxyribonucleic acid ("DNA") sequences known as genes. The process by which cells use the information contained in genes to make corresponding  [*1118]  proteins is referred to as expression. Expression involves two steps, viz., transcription and translation. During transcription, the information contained in a gene is copied into messenger ribonucleic acid ("mRNA"). The cell then assembles amino acids in the proper sequence during translation to make the protein based on the information contained in the mRNA.

One gene in the bacterium E. coli, called the E. coli polA gene, encodes a protein known as E. coli DNA polymerase I. Since at least the 1970s, the E. coli polA gene has been the subject of scientific study. The wild-type E. coli polA  [**3] gene consists of two parts--the structural gene (or gene coding region) and a promoter, which is a DNA sequence that is involved in initiating transcription. The expression of a gene can be regulated through the use of a promoter by controlling the level of transcription.

Some valuable proteins are either difficult to purify from their natural sources or occur in minute quantities in nature. Thus, methods have been developed in the field of biotechnology [***1235]  "to synthesize useful quantities of specific proteins by controlling the mechanism by which living cells make proteins." Carnegie Mellon Univ. v. Hoffmann-La Roche, Inc., 55 F. Supp. 2d 1024, 1027 (N.D.Cal. 1999).

Read The Full CaseNot a Lexis Advance subscriber? Try it out for free.

Full case includes Shepard's, Headnotes, Legal Analytics from Lex Machina, and more.

541 F.3d 1115 *; 2008 U.S. App. LEXIS 22350 **; 88 U.S.P.Q.2D (BNA) 1233 ***

CARNEGIE MELLON UNIVERSITY and THREE RIVERS BIOLOGICALS, INC., Plaintiffs-Appellants, v. HOFFMANN-LA ROCHE INC., ROCHE MOLECULAR SYSTEMS, INC., ROCHE DIAGNOSTIC SYSTEMS, INC., ROCHE BIOMEDICAL LABORATORIES, INC., THE PERKIN-ELMER CORPORATION, and LABORATORY CORPORATION OF AMERICA HOLDINGS, Defendants-Appellees. CARNEGIE MELLON UNIVERSITY, Plaintiff-Appellant, v. HOFFMANN-LA ROCHE INC., ROCHE MOLECULAR SYSTEMS, INC., ROCHE DIAGNOSTICS CORPORATION, LABORATORY CORPORATION OF AMERICA; and APPLERA CORPORATION, Defendants-Appellees.

Subsequent History: Rehearing denied by, Rehearing, en banc, denied by Carnegie Mellon Univ. v. Hoffmann-La Roche, Inc., 2008 U.S. App. LEXIS 25398 (Fed. Cir., Nov. 10, 2008)

Rehearing denied by, Rehearing, en banc, denied by Carnegie Mellon Univ. v. Hoffmann-La Roche, Inc., 2008 U.S. App. LEXIS 25395 (Fed. Cir., Nov. 10, 2008)

Prior History:  [**1] Appeal from the United States District Court for the Northern District of California in Case Nos. 95-CV-3524 and 01-CV-0415, Judge Susan Illston.

Carnegie Mellon Univ. v. Hoffmann-LaRoche, Inc., 55 F. Supp. 2d 1024, 1999 U.S. Dist. LEXIS 16051 (N.D. Cal., 1999)Carnegie Mellon Univ. v. Hoffman-La Roche, Inc., 2004 U.S. Dist. LEXIS 4975 (N.D. Cal., Feb. 25, 2004)Carnegie Mellon Univ. v. Hoffman La Roche Inc., 148 F. Supp. 2d 1004, 2001 U.S. Dist. LEXIS 12463 (N.D. Cal., 2001)

Disposition: AFFIRMED.

CORE TERMS

patent, plasmid, invention, bacterial, polymerase, sequence, written description, polA, recombinant, invalid, coli, coding, genus, district court, promoter, species, host, specification, infringe, encodes, cloned, noninfringement, summary judgment, enzyme, appellants', genuine issue of material fact, lethality, disclose, proteins, region

Civil Procedure, Summary Judgment, Entitlement as Matter of Law, Appropriateness, Appeals, Summary Judgment Review, Standards of Review, General Overview, Patent Law, Specifications, Description Requirement, Written Description Versus Enablement, Standards & Tests, Infringement Actions, Doctrine of Equivalents, Equivalence Limits, Elements