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CARNEGIE MELLON UNIVERSITY v. HOFFMAN-LA ROCHE

June 27, 2001

CARNEGIE MELLON UNIVERSITY AND THREE RIVERS BIOLOGICALS, INC., PLAINTIFFS,
V.
HOFFMAN-LA ROCHE INC., ROCHE MOLECULAR SYSTEMS, INC., ROCHE DIAGNOSTIC SYSTEMS, INC., ROCHE BIOMEDICAL LABORATORIES, INC., LABORATORY CORPORATION OF AMERICA HOLDINGS, INC., THE PERKIN-ELMER CORPORATION, CHIRON CORPORATION, AND CETUS ONCOLOGY CORPORATION, DEFENDANTS.



The opinion of the court was delivered by: Illston, District Judge.

 
ORDER GRANTING DEFENDANTS' RENEWED MOTION FOR SUMMARY JUDGMENT

On March 16, 2001, the Court heard argument on the Roche*fn1 defendants' motion for summary judgment on their counterclaim for declaratory judgment that claims 1-19, 22-40 and 43-45 of the `708 patent are invalid. Having carefully considered the arguments of counsel and the papers submitted, the Court GRANTS the motion for the reasons set forth below.

BACKGROUND

Plaintiffs Carnegie Mellon University ("Carnegie Mellon") and Three Rivers Biologicals, Inc. filed suit against several defendants alleging infringement of U.S. Patent No. 4,767,708 ('708 patent) and U.S. Patent No. 5,126,270 ('270 patent), both entitled "Enzyme Amplification and Purification." The patents-in-suit are directed to (1) recombinant plasmids for the controlled expression of an enzyme identified in the '708 patent as "DNA polymerase I," (2) processes related to the construction of such plasmids, and (3) processes related to the culturing of host cells containing such plasmids.*fn2 The patents derive from the same original application. The Patent and Trademark Office ("PTO") issued the '708 patent from a "parent" application, No. 06/638, 638 ('638 application) filed on August 7, 1984, and the '270 Patent from a "continuation" application filed on November 5, 1987.

The Roche defendants deny the infringement charge and assert an affirmative defense that the claims of the '708 and '270 patents are invalid for numerous reasons, including failure to meet the written description requirement of 35 U.S.C. § 112. See Roche Defts.' Answer to Second Amended Complaint ¶ 21. The Roche defendants asserted one counterclaim seeking declaratory judgment that, inter alia, the claims of the '708 and '270 patent are invalid. See id. at ¶¶ 25, 38.

In August 1997, the Roche defendants moved for summary judgment on their counterclaim with respect to the '708 patent. They argued that claims 1-19, 22-40 and 43-45 of the '708 patent are invalid under the written description requirement of 35 U.S.C. § 112, as articulated by Regents of the University of California v. Eli Lilly & Co., 119 F.3d 1559 (Fed.Cir. 1997). The Roche defendants did not submit expert evidence with that motion, instead relying exclusively on the '708 patent, its prosecution history, and the Eli Lilly decision. The Court denied the motion, holding that "the Court cannot find that no reasonable trier of fact might conclude that the '708 patent's written description is sufficient." Order (Feb. 3, 1998) 1:26-28.

In July 1999, the Roche defendants moved for summary judgment that certain claims of the '270 patent were invalid under the written description requirement. They once again relied on Eli Lilly, but also added an alternative "omitted element" argument pursuant to Gentry Gallery, Inc. v. Berkline Corp., 134 F.3d 1473 (Fed.Cir. 1998). The Court found the Gentry argument persuasive and held that the '270 patent was invalid because it failed to incorporate lethality, which was an essential feature of the claimed invention. Order (Aug. 19, 1999) 10-11. The Court did not rule on whether the '270 patent also violated the requirements of Eli Lilly. Id. at 11.

Now before the Court is a renewed motion by the Roche defendants for summary judgment on their counterclaim for declaratory judgment that claims 1-19, 22-40 and 43-45 of the '708 patent are invalid under the written description requirement.

RELEVANT TECHNOLOGY*fn3

Proteins are biological molecules of enormous importance. Proteins include enzymes that catalyze biochemical reactions, major structural materials of the animal body, and many hormones. Numerous patents and applications for patents in the field of biotechnology involve specific proteins or methods for making and using proteins. Many valuable proteins occur in nature only in minute quantities, or are difficult to purify from natural sources. Therefore, a goal of many biotechnology projects is to devise methods to synthesize useful quantities of specific proteins by controlling the mechanism by which living cells make proteins.

Protein molecules are composed of long chains of amino acids. To make a protein molecule, a cell needs information about the sequence in which the amino acids must be assembled. The cell uses DNA — deoxyribonucleic acid — to store this information. DNA molecules do not participate directly in the synthesis of proteins, but instead act as a permanent "blueprint" for the synthesis of a protein.

DNA is comprised of building blocks called nucleotides that are linked together to form a strand. Due to the orientation of nucleotides, each strand of DNA has a 5' end and a 3' end. The sequence and combination of nucleotides in DNA determines the sequence of amino acids in a particular protein. DNA predominantly exists in long-stranded structures called chromosomes, but can also be found in smaller circular structures called plasmids. The specific region of DNA that codes for the sequence of a particular protein is called a gene.

In order to make a selected protein by expressing its cloned gene in bacteria, several technical hurdles must be overcome. First the particular gene coding for the specific protein must be isolated for cloning. Next the isolated gene must be introduced into the host bacterium. This can be done by incorporating the gene into a cloning vector. A cloning vector is a piece of DNA that can be introduced into bacteria and will then replicate itself as the bacterial cells grow and divide. Plasmids are often used as cloning vectors due to their small size and ability to replicate in host cells. A recombinant plasmid is a plasmid that has been artificially constructed (i.e. cloned), rather than isolated from nature. Recombinant DNA technology can be used to modify plasmids by splicing in cloned genes and other useful segments of DNA containing control sequences.

The '708 patent is directed to a recombinant plasmid containing a gene that encodes the useful enzyme DNA polymerase I. The encoding gene is commonly referred to as the "polA" gene, and the enzyme it encodes, DNA polymerase I, is also known as the "pol I" enzyme. Furthermore, it is common in the art to refer to an enzyme by also naming the type of cell in which its encoding gene naturally exists. See Declaration of Steven J. Benkovic (Oct. 9, 1997) ("1997 Benkovic Decl.") ¶ 8. Thus, "E. coli DNA polymerase I" describes a DNA polymerase I enzyme that was produced by a polA gene which originated in an E. coli bacterial cell.

LEGAL STANDARD

A party seeking to invalidate a patent must overcome a presumption that the patent is valid. 35 U.S.C. § 282; United States Gypsum Co. v. National Gypsum Co., 74 F.3d 1209, 1212 (Fed.Cir. 1996); Hybritech Inc. v. Monoclonal Antibodies, Inc., 802 F.2d 1367, 1375 (Fed.Cir. 1986). This presumption places the burden on the challenging party to prove the patent's invalidity by clear and convincing evidence. United States Gypsum Co., 74 F.3d at 1212. Within this scheme of proof, "[s]ummary judgment is appropriate in a patent case, as in other cases, when there is no genuine issue as to any material fact and the moving party is entitled to judgment as a matter of law." Nike Inc. v. Wolverine World Wide, Inc., 43 F.3d 644, 646 (Fed.Cir. 1994).

A motion for summary judgment may be granted when "the pleadings, depositions, answers to interrogatories, and admissions on file, together with the affidavits, if any, show that there is no genuine issue as to any material fact and that the moving party is entitled to a judgment as a matter of law." Fed.R.Civ.P. 56(c). The moving party bears the initial burden of "informing the district court of the basis for its motion" and identifying the matter that "it believes demonstrate[s] the absence of a genuine issue of material fact." Celotex Corp. v. Catrett, 477 U.S. 317, 323, 106 S.Ct. 2548, 2553, 91 L.Ed.2d 265 (1986). If the moving party meets this burden, the nonmoving party must then set forth "specific facts showing that there is a genuine issue for trial." Fed.R.Civ.P. 56(e); see also T.W. Elec. Serv., Inc. v. Pacific Elec. Contractors Ass'n, 809 F.2d 626, 630 (9th Cir. 1987). "Rule 56(c) requires the moving party to show not only the absence of a disputed issue of fact but also that he is entitled to judgment as a matter of law . . . [T]herefore, the court must . . . consider the burden of proof on the issue and where it will rest at trial . . . Where the moving party has the burden — the plaintiff on a claim for relief or the defendant on an affirmative defense — his showing must be sufficient for the court to hold that no reasonable trier of fact could find other than for the moving party." Calderone v. United States, 799 F.2d 254, 259 (6th Cir. 1986) (quotations omitted).

The evidence presented by the parties in support of or opposition to a motion for summary judgment must be admissible. See Fed.R.Civ.P. 56(e). In evaluating this evidence, the Court does not make credibility determinations or weigh conflicting evidence, and draws all inferences in the light most favorable to the nonmoving party. T.W. Elec. Serv., 809 F.2d at 630-31 (citing Matsushita Elec. Indus. Co. v. Zenith Radio Corp., 475 ...


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