Of the biology-->
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 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.
One method involves introducing foreign genes into a bacterium, which can then
replicate as the bacterium grows and divides. Such a method involves several steps,
including isolating and cloning the gene that encodes the protein of interest and
introducing the cloned gene into the host bacterium. The latter is accomplished by
incorporating the gene into a cloning vector. Certain types of vectors include
bacteriophages and plasmids, which are “small circular loop[s] of DNA found in bacteria,
separate from the chromosome, that replicate like a chromosome.”
The patents in suit, viz., U.S. Patents 4,767,708 (“the ’708 patent”), 5,126,270
(“the ’270 patent”), and 6,017,745 (“the ’745 patent”) relate to “novel recombinant
plasmids for the enhanced expression of an enzyme, to the preparation by gene cloning
of such plasmids, to bacterial strains containing said plasmids, [and] to methods for the
conditional control of the expression of said enzyme.”1 ’708 patent col.1 ll.7-16.
The patents teach that the enzyme of interest is DNA polymerase I (Pol I), which,
as discussed above, is encoded by the structural gene known as polA.
Claim 1 of the '708 patent-->
1. A recombinant plasmid containing a cloned complete structural gene
coding region isolated from a bacterial source for the expression of DNA
polymerase I, under operable control of a conditionally controllable foreign
promoter functionally linked to said structural gene coding region, said
foreign promoter being functional to express said DNA polymerase I in a
suitable bacterial or yeast host system.
The accused product at issue in this appeal involves a recombinant plasmid referred to as
Of invalidity, written description was at issue-->
Roche filed separate motions for summary judgment seeking judgment that: 1) claims 1-19, 22-
40, and 43-45 of the ’708 patent were invalid for lack of written description under our
holding in Regents of University of California v. Eli Lilly & Co., 119 F.3d 1559 (Fed. Cir.
As to the '708 patent, the issue was -->
The court concluded that while the claims of the ’708 patent claim recombinant plasmids
“containing a cloned complete structural gene coding region from [any] bacterial
sources for the expression of DNA polymerase I,” the ’638 application only described
recombinant plasmids containing the encoding gene region for E. coli DNA polymerase I
and thus failed to adequately support the generic claims of the ’708 patent.
In addressing the "written description" argument, the CAFC made short work of various
law professor theories about written description -->
Thus, paragraph 1 of § 112 requires a written description of the invention—a requirement separate and distinct from the enablement requirement. Vas-Cath Inc. v. Mahurkar, 935 F.2d 1555, 1563 (Fed. Cir. 1991); see
Festo Corp. v. Shoketsu Kinzoku Kogyo Kabushiki Co., Ltd., 535 U.S. 722, 736 (2002)
Yes, the COX-2 case was cited, Univ. of Rochester v. G.D. Searle
& Co., Inc., 358 F.3d 916, 922 (Fed. Cir. 2004), another case wherein a university went down on summary
Of the scope of Lilly--> Roche asserts that Eli Lilly applies
to the present case as there was nothing in the Eli Lilly decision to suggest that that
holding was limited to inventions involving novel DNA sequences.
Of the written description issue-->
The appealed claims of the ’708 patent are directed to recombinant plasmids that
contain a DNA coding sequence that is broadly defined, and only by its function, viz.,
encoding DNA polymerase I. Moreover, the generic claims are not limited to a single
bacterial species, but broadly encompass coding sequences originating from any
The USPTO Guidelines state:
The written description requirement for a claimed genus may be satisfied
through sufficient description of a representative number of species . . . by
disclosure of relevant, identifying characteristics, i.e., structure or other
physical and/or chemical properties, by functional characteristics coupled
with a known or disclosed correlation between function and structure, or
by a combination of such identifying characteristics, sufficient to show the
applicant was in possession of the claimed genus.
A “representative number of species” means that the species which are
adequately described are representative of the entire genus. Thus, when
there is substantial variation within the genus, one must describe a
Satisfactory disclosure of a “representative number” depends on whether
one of skill in the art would recognize that the applicant was in possession
of the necessary common attributes or features of the elements
possessed by the members of the genus in view of the species disclosed.
For inventions in an unpredictable art, adequate written description of a
genus which embraces widely variant species cannot be achieved by
disclosing only one species within the genus.
The CAFC found insufficient disclosure-->
the narrow specifications of the ’708 and ’745 patents only disclose the polA gene coding sequence from one bacterial
source, viz., E. coli. Significantly, the specification fails to disclose or describe the polA
gene coding sequence for any other bacterial species.
Notably, the record indicates that at the time of the invention, only three
bacterial polA genes, viz., E. coli, K. aerogenes, and K. pneumoniae, out of thousands
of bacterial species had been cloned, and only E. coli was described in the patents.
Unlike the situation in Capon, however, where the prior art contained “extensive
knowledge of the nucleotide structure of the various immune-related segments of DNA,”
including “over 785 mouse antibody DNA light chains and 1,327 mouse antibody DNA
heavy chains,” id. at 1355, the record here shows that only three bacterial polA genes
out of thousands of genes had been cloned.
Of Gentry Gallery-->
Rather, “we applied and merely expounded upon the unremarkable proposition that a
broad claim is invalid when the entirety of the specification clearly indicates that the
invention is of a much narrower scope.”