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 U.S. 574, 106 S.Ct. 1348, 89 L.Ed.2d 538 (1986)); Ting v.
United States, 927 F.2d 1504, 1509 (9th Cir. 1991).
In their renewed motion for summary judgment, the Roche
defendants again rely on Regents of the University of
California v. Eli Lilly, 119 F.3d 1559 (Fed.Cir. 1997), to
argue that the '708 patent is invalid because it fails to
satisfy the written description requirement of 35 U.S.C. § 112.
Unlike their first motion for summary judgment, the Roche
defendants now offer the Declaration of Professor Robert A.
Bambara (July 2, 1999) ("1999 Bambara Decl."), which sets forth
facts and expert opinions to support the argument that the '708
patent squarely violates the Eli Lilly standard for written
descriptions. Plaintiffs counter that the Court must defer to
the PTO's original decision to issue the '708 patent, which
implicitly includes a determination that the written description
requirement was met.*fn4 Furthermore, plaintiffs argue that
Eli Lilly does not apply, and assuming it does apply, that the
'708 patent satisfies the Eli Lilly standard for written
descriptions of DNA technology patents.
The written description requirement is contained in
35 U.S.C. § 112, which states: "[t]he specification shall contain a
written description of the invention, and of the manner and
process of making and using it, in such full, clear, concise,
and exact terms as to enable any person skilled in the art to
which it pertains . . . to make and use [the invention]." The
requirement serves "to ensure that the inventor had possession,
as of the filing date of the application relied on, of the
specific subject matter later claimed by him." In re Alton,
76 F.3d 1168, 1172 (Fed.Cir. 1996) (citing In re Wertheim,
541 F.2d 257, 262 (Cust. & Pat.App. 1976)). Whether the
specification for a challenged claim meets this requirement is a
question of fact to be assessed on a case-by-case basis.
Vas-Cath Inc. v. Mahurkar, 935 F.2d 1555, 1561, 1563 (Fed.Cir.
1991); Eli Lilly, 119 F.3d at 1566.*fn5
In order to satisfy the written description requirement, the
specification must convey with reasonable clarity to those
skilled in the art that the inventor was in possession of the
invention. In re Gosteli, 872 F.2d 1008, 1012 (Fed. Cir. 1989)
("[T]he description must clearly allow persons of ordinary skill
in the art to recognize that [the inventor] invented what is
claimed."); see also Eli Lilly, 119 F.3d at 1566; Vas-Cath,
935 F.2d at 1563. "One shows that one is `in possession' of the
invention by describing the invention, with all its claimed
limitations. . . . by such descriptive means as words,
structures, figures, diagrams, formulas, etc." Lockwood v.
American Airlines, Inc., 107 F.3d 1565, 1572 (Fed.Cir. 1997)
(emphasis omitted). See also In re Wertheim, 541 F.2d 257, 262
(Cust. & Pat.App. 1976) ("The primary consideration is factual
and depends on the nature of the invention and the amount of
knowledge imparted to those skilled in the art by the
disclosure."). Expert testimony eliciting industry standards can
work to "expand the breadth of the actual written description."
In re Alton, 76 F.3d 1168, 1176 (Fed.Cir. 1996).
A. Administrative Deference to the Patent and Trademark
As stated earlier, a party challenging a patent must overcome
the presumption that the patent is valid by offering clear and
convincing proof of the patent's invalidity. 35 U.S.C. § 282;
United States Gypsum Co., 74 F.3d at 1212; Hybritech, 802
F.2d at 1375. The challenging party's burden also includes
overcoming deference to the PTO's findings and decisions in
prosecuting the patent application. Deference to the PTO is due
"[w]hen no prior art other than that which was considered by the
PTO examiner is relied on by the attacker." American Hoist &
Derrick Co. v. Sowa & Sons,