The opinion of the court was delivered by: Illston, District Judge.
ORDER GRANTING DEFENDANTS' RENEWED MOTION FOR SUMMARY
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.
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.
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)
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
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
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
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)
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.,