5. Acid-Labile Pharmaceutically Active Substance
Genpharm argues that claim 1 and all other asserted claims of
the '230 patent are invalid for lack of support under
35 U.S.C. § 112 based on the allegedly unsupported scope of the claim
limitation "acid-labile pharmaceutically active substance." At a
minimum, the claim term "acid-labile pharmaceutically active
substance" encompasses all of the benzimidazoles set forth in
the specification of the '230 patent. (P2A, col. 5:48 — col.
7:58; Story Tr. 4682:3-7; Langer Tr. 556:9-558:16; Pilbrant Tr.
1547:2-7; Lövgren Tr. 4487:20-4488:6.) Genpharm argues that the
three examples provided in the '230 patent are not
representative of the compounds listed in the specification.
Defendants rely on the testimony of Dr. Lövgren to suggest that
the '230 patent is not enabled because information for
formulating one benzimidazole compound allegedly cannot be
extrapolated to benzimidazole compounds. Defendants fail to
acknowledge that the testimony of Dr. Lövgren makes it clear
that a skilled formulator would be able to extrapolate among
benzimidazole compounds. (Lövgren Tr. 4488:15-24.) Dr. Lövgren
explained that even though they are different substances,
different benzimidazoles share many properties. (Lövgren Tr.
4489:13-17.) Defendants further assert that the three
formulations exemplified in the '230 patent are not remotely
representative of all the benzimidazole compounds and that those
examples do not teach a formulator how to use the claimed
formulations. In particular, Defendants rely on Dr. Story, who
testified that "there are absolutely no examples whatsoever to
demonstrate that the compound, any compound that is included
under Claim 1 in fact works." (Story Tr. 4684:3-6.) In the end,
Dr. Story and Defendants would have the court believe that none
of the sixteen different patents and patent applications
concerning benzimidazole compounds recited in column 2 of the
'230 patent disclose compounds that will be biologically active.
(See P2A, col. 1:5-11 (noting that field of invention relates
to method of affecting gastric acid secretion).) Dr. Story's
conclusory testimony is insufficient to establish invalidity.
The court finds that Defendants have failed to meet their burden
to establish invalidity of the asserted claims of the '230
patent under § 112.
6. "Stability of the Preparation is Enhanced"
In addition, Genpharm argues that claims 1 and 12 of the '230
patent and all asserted dependent claims are invalid for lack of
enablement and indefiniteness under 35 U.S.C. § 112 based on the
allegedly undefined and unsupported claim limitation of enhanced
stability. Dr. Story criticizes the claims because the patent
lacks data showing that "the stability of the preparation is
enhanced." (Story Tr. 4581:24-4583:20.) Examples are, however,
not required to satisfy section 112, first paragraph. In re
Strahilevitz, 668 F.2d 1229, 1232 (C.C.P.A. 1982). Accordingly,
in the present case, there is no requirement that the '230
patent include any examples of stability data, as long as the
disclosure enables one of ordinary skill in the art to make and
use the invention. (See Story Tr. 4817:18-4822:8.) Defendants
provide no evidence that stability is not enhanced as described
and claimed in the '230 patent, and the court finds that
Defendants have failed to demonstrate that the claims are not
Genpharm also argues, as it does with respect to
"microenvironment," that the phrase "the stability of the
preparation is enhanced" does not particularly point out and
distinctly claim the invention, as required by the second
section 112. Genpharm's contentions are based on a presumption,
not required by law or logic, that this phrase must have some
express definition or be supported by specific, numerical tests.
"Enhanced," however, has its ordinary meaning as a relative
term, which directly implies a comparison. The point of
comparison is plainly relative to a formulation without the
claimed subcoating. This construction directly flows from the
claim language. (P2A, col. 13:17-20 ("wherein the subcoating
layer isolates the alkaline reacting core from the enteric
coating layer such that the stability of the preparation is
enhanced").) "Stability" is defined in the specification in
terms of gastric acid resistance and degradation of omeprazole.
(P2A, col. 10:26-28 ("Without this separating layer the
resistance towards gastric juice would be too short and storage
stability of the dosage form would be unacceptably short.").)
Additional references to degradation and discoloration during
manufacture and storage and to gastric acid resistance are also
present in the patent. (P2A, col. 9:1-4, col. 3:66 — col. 4:56.)
The '230 patent specification further teaches that without the
subcoating the enteric coating would "otherwise cause
degradation/discoloration of the acid labile compound during the
coating process o[r] during storage," (P2A, col. 9:1-4), and
that gastric acid resistance is thereby decreased, (see P2A,
col. 3:66 — col. 4:56). Accordingly, "stability" has two points
of reference: the subcoating layer cannot decrease the gastric
acid resistance or accelerate omeprazole degradation. Both
properties must be better — enhanced — compared to the
formulation without the subcoating. See Seattle Box Co. v.
Indus. Crating & Packing, Inc., 731 F.2d 818, 826 (Fed.Cir.
1984) ("When a word of degree is used the district court must
determine whether the patent's specification provides some
standard for measuring that degree," such that a person of
ordinary skill in the art would understand what is claimed.). In
view of these standards relative to stability, and the allowance
of the claims by the Patent Examiner, who presumably found them
clear, it is irrelevant that there are no tests or data
concerning enhanced stability and no express numerical
definitions of "enhanced stability" in the patent. See Andrew
Corp. v. Gabriel Elecs., Inc., 847 F.2d 819, 823 (Fed.Cir.
1988) ("The law imposes no obligation on a patent applicant to
. . . set the claim limits at the precise technological edge of
the invention. A claim is not fatally indefinite for failing
specifically to delineate the point at which the change in
physical phenomenon occurs.") No evidence in the record beyond
Dr. Story's conclusory statements regarding invalidity under
section 112 supports Genpharm's argument. The court finds that
Defendants have failed to provide clear and convincing evidence
that the examiner erred in concluding that the claims were sound
and in issuing the claims of the '230 patent.
Defendant Genpharm argues that nine different combinations of
the prior art render claim 1 of the '505 patent invalid for
either lack of novelty or obviousness. Twelve different
combinations of the prior art are asserted against the claims of
the '230 patent. With respect to anticipation specifically,
Genpharm argues that Astra's European Patent Application No. 0
124 495 (the "'495 patent") titled Omeprazole Salts and
published on November 7, 1984, (see G345), renders claims 1,
8, 10, and 14 of the '505 patent invalid for lack of novelty.
Genpharm also alleges that Astra's European Patent Application
No. 0 173 664 (the "'664 patent") titled Biologically Active
Benzimidazole Compounds and Process for Their Preparation and
published on March 5, 1986, (see G23A),
renders claims 1, 10, 12, and 13 and of the '230 patent invalid
for lack of novelty.
A patent may not issue, and is invalid as anticipated, where
the claimed invention "was patented or described in a printed
publication in this or a foreign country . . . more than one
year prior to the date of the application for patent in the
United States." 35 U.S.C. § 102(b). It is well-settled that if a
single prior art reference published more than one year before
the date the patent application was filed*fn91 discloses each
and every limitation set forth in a claim, either expressly or
inherently, the claim is invalid. In re Schreiber,
128 F.3d 1473, 1477 (Fed.Cir. 1997); Verdegaal Bros. v. Union Oil Co.,
814 F.2d 628, 631 (Fed.Cir. 1987). When the claimed invention
"reads on" a prior art reference, the invention is said to be
anticipated by that reference, and any claim purporting to
patent the invention is deemed invalid. See Atlas Powder Co. v.
IRECO Inc., 190 F.3d 1342, 1346 (Fed.Cir. 1999) (citing
Titanium Metals Corp. v. Banner, 778 F.2d 775, 781 (Fed.Cir.
1985)). To anticipate, a printed publication must also be
enabling. In re Donohue, 766 F.2d 531, 533 (Fed.Cir. 1985).
With respect to a formulation patent claim, like many of the
asserted claims of the '505 and '230 patents, the test of
whether a prior art publication describes the thing that is
claimed is whether that publication placed the claimed invention
"in the possession of the public" as of the date the invention
was made. The invention is placed "in the possession of the
public" only where the reference "describes" the claimed
invention to one of ordinary skill in the art — the "identity of
invention" requirement — and where one skilled in the art would
have been able to make it as of that time based on his own
knowledge and the teaching of the publication — the "enablement"
requirement. See Paperless Accounting, Inc. v. Bay Area Rapid
Transit Sys., 804 F.2d 659, 665 (Fed.Cir. 1986); In re Yale,
58 C.C.P.A. 764, 434 F.2d 666, 668-69 (C.C.P.A. 1970). The
anticipation analysis comprises two steps. By construing the
content and scope of the claims of the patents at issue, the
court has already completed the first step. In the second step,
the court must compare the properly construed claims to the
allegedly anticipating prior art. See Helifix, Ltd. v.
Blok-Lok, Ltd., 208 F.3d 1339, 1346 (Fed.Cir. 2000). For a
patent to be held invalid for prior description in an
anticipating reference, there must be identity of invention
between what is disclosed in the reference and the invention as
claimed. Gen. Elec. Co. v. Nintendo Co., 179 F.3d 1350, 1355
(Fed.Cir. 1999); Hoover Group, Inc. v. Custom Metalcraft,
Inc., 66 F.3d 299, 302 (Fed.Cir. 1995). Identity of invention
is a question of fact. Finnigan Corp. v. Int'l Trade Comm'n,
180 F.3d 1354, 1362 (Fed.Cir. 1999); Minnesota Mining & Mfg.
Co. v. Johnson & Johnson Orthopaedics, Inc., 976 F.2d 1559,
1565 (Fed.Cir. 1992). All of the claimed elements must be found
within the four corners of that single publication, either
expressly or inherently, as it is understood by the
hypothetical person of ordinary skill in the art. See ATD Corp.
v. Lydall Inc., 159 F.3d 534, 545 (Fed.Cir. 1998); Scripps
Clinic & Research Found. v. Genentech, Inc., 927 F.2d 1565,
1576-77 (Fed.Cir. 1991). The person of ordinary skill in the art
is a hypothetical person who is
presumed to have the skill and experience of only an ordinary
worker in the field but knowledge of everything known in the
art. See Custom Accessories, Inc. v. Jeffrey-Allan Indus.,
Inc., 807 F.2d 955, 962 (Fed. Cir. 1986).
Under the principles of inherency, if the prior art
necessarily functions in accordance with, or
includes, the claimed limitations, it anticipates
. . . the discovery of a previously unappreciated
property of a prior art composition, or of a
scientific explanation for the prior art's
functioning, does not render the old composition
patentably new to the discoverer.
Atlas Powder Co. v. IRECO Inc., 190 F.3d 1342, 1347
(Fed.Cir. 1999). Newly discovered results of known processes
directed to the same purpose are inherent and unpatentable. See
Bristol-Myers Squibb Co. v. Ben Venue Labs., 246 F.3d 1368,
1376 (Fed.Cir. 2001) (citing In re May, 574 F.2d 1082, 1090
(C.C.P.A. 1978)). Whether a person ordinarily skilled in the art
would have recognized the inherent characteristics of the
functioning of the prior art is irrelevant, if those inherent
characteristics indeed exist. See Atlas Powder, 190 F.3d at
1349 ("Insufficient prior understanding of the inherent
properties of a known composition does not defeat a finding of
anticipation.") (citing Titanium Metals, 778 F.2d at 782).
The court finds that Defendants have failed to prove facts
that show clearly and convincingly that any single reference,
read as one of ordinary skill in the art at the time of the
invention would read it, describes each and every element of any
claim of the '505 or the '230 patent. The first prior art
reference that Defendants sponsor in support of their
anticipation argument is Astra's European Patent Application No.
0 124 495 A2 (the "'495 patent") titled Omeprazole Salts that
was published on November 7, 1984. (G345.) Arne Brandström is
the only inventor listed on the '495 patent, which describes
salts of omeprazole and discloses processes for their
preparation, pharmaceutical compositions containing such salts,
and their use in medicine. (Story Tr. 4593:4-8; G345, Front
Page.) The court finds that the '495 patent does not disclose an
inert subcoating disposed on the core, (see Langer Tr.
5025:14-18); therefore, the '495 patent does not anticipate the
claims of either the '505 or the '230 patent.
The '495 patent is not a formulation patent; no formulations
are described on page 7 or any other place in the specification
of that patent except for the examples. (Lövgren Tr.
4546:5-4547:8.) Example 12 of the '495 patent is the only solid
dosage formulation actually exemplified in the patent, and there
is no subcoat in that example. (Story Tr. 4792:25-4793:22;
Langer Tr. 5037:1-2; Lövgren Tr. 4547:22-4548:6.) Instead,
Example 12 uses an enteric coating placed directly on the
omeprazole salt-containing core. (Langer Tr. 5036:12-25; Lövgren
Tr. 4548:6-8.) Thus, the '495 patent teaches omeprazole salt
formulations that are enteric-coated but do not employ a
subcoating. (Langer Tr. 5030:10-5031:1, Pill at 6.) When the
'495 patent refers to gelatin capsules, it does not call them
subcoatings. (Story Tr. 4790:12-14.) The '495 patent also does
not describe a subcoating anywhere in the disclosure. (Story Tr.
4790:5-11; Langer Tr. 5025:14-18.)
Set forth below is the portion of the '495 patent disclosure
that Defendants focus on for their invalidity assertion:
Soft gelatine capsules may be prepared with capsules
containing a mixture of the active compound or
compounds of the invention, vegetable oil, fat, or
other suitable vehicle for soft gelatine capsules.
Soft gelatine capsules are preferably enteric coated
as described above. Hard gelatine capsules may
enteric-coated granules of the active compound. Hard
gelatine capsules may also contain the active
compound in combination with a solid powdered carrier
e.g. lactose, saccharose, sorbitol, mannitol, potato
starch, corn starch, amylopectin, cellulose
derivatives or gelatine; the hard gelatine capsules
are preferably enteric coated as described above.
(G345, 7:1-10.) Defendants argue that the excerpt describing
enteric coating filled capsules discloses a subcoating. However,
based on the ordinary meaning of the terms "subcoating" and
"capsule," the patent specifications and the file histories for
the '505 and '230 patents, the foreign proceedings raised by
Genpharm, and other extrinsic evidence, the court has previously
held that the term "subcoating," as it appears in claims 1 of
the '505 and '230 patents does not include gelatine capsules.
See supra Part II.D.2. To the person of ordinary skill at the
time of the patents, then, the '495 patent would have been
understood to describe formulations that do not include a
subcoat, and the '495 patent fails on the "identify of
invention" prong of the anticipation test. The court concludes
that the '495 patent does not anticipate claims 1 of the '505
and '230 patents because it does not describe the "subcoating"
required by the claims. As for the remaining asserted claims of
the '505 and '230 patents, all claims require the subcoating of
claims 1(b), or, in the case of the process claim, the
application of such a subcoating. Therefore, the '495 patent
does not anticipate any of the asserted claims in the '505 or
'230 patents. See Intermatic Inc. v. Lamson & Sessions Co.,