The opinion of the court was delivered by: Walls, District Judge.
Defendants and counterclaimants Zenith Goldline
Pharmaceuticals, IVAX Corporation, Baker Norton Pharmaceuticals,
Immunex Corporation (collectively the "IVAX defendants") and Ben
Venue Laboratories ("Ben Venue") move for summary judgment of
invalidity of United States Patents Nos. 5,670,537 ("'537
patent") and 5,641,803 ("'803 patent") on the grounds of
anticipation, 35 U.S.C. § 102(b), and obviousness,
35 U.S.C. § 103. Plaintiff Bristol-Myers Squibb ("Bristol") opposes the
motions. The motions are granted in part.
Ben Venue's first motion for summary judgment of invalidity
asserts that claims 1, 2, 5, 6, 8 and 9 of the '537 patent are
invalid as anticipated or obvious by Mark Kris, et al., Phase I
of Taxol Given as a 3-Hour Infusion Every 21 Days, 70 Cancer
Treatment Reports 605-07 (1986) (the "Kris article"). Ben Venue
further asserts that all claims of this patent are invalid as
obvious from a written abstract ("OV.9 abstract") and oral
presentation at an April 1991 meeting of the Clinical Trials
Group of the National Cancer Institute of Canada ("NCIC"). Ben
Venue's second motion for summary judgment of invalidity asserts
that claims 1-3 and 6 of the '803 patent are anticipated by the
Kris article and all claims of the '803 patent are anticipated by
the OV.9 abstract. Zenith Goldline Pharmaceuticals, IVAX
Corporation, Baker Norton Pharmaceuticals, and Immunex
Corporation, in their motion, contend that claims 1-3 and 6 of
the '803 patent and claims 1, 2, 5, and 8 of the '537 patent are
anticipated by the Kris article; all claims of both patents are
anticipated by the OV.9 abstract; and, all claims of both patents
are invalid as obvious when the prior art, including but not
limited to the Kris article and the OV.9 abstract, is considered
in its entirety. Bristol responds that summary judgment is
inappropriate and further argues that the prior art neither
anticipates nor renders obvious the patents at issue.
Summary Judgment Standard
Patent cases are not immune to summary judgment motions. The
Federal Circuit has "repeatedly emphasized that `summary judgment
is as appropriate in a patent case as any other.'" Avia Group
Int'l, Inc. v. L.A. Gear California, 853 F.2d 1557, 1561
(Fed.Cir. 1988). Summary judgment is appropriate where the moving
party establishes that "there is no genuine issue of fact and
that [it] is entitled to a judgment as a matter of law." Fed.
R.Civ.P. 56. A factual dispute between the parties will not
defeat a motion for summary judgment unless it is both genuine
and material. See Anderson v. Liberty Lobby, Inc.,
477 U.S. 242, 247-48, 106 S.Ct. 2505, 91 L.Ed.2d 202 (1986). A factual
dispute is genuine if a reasonable jury could return a verdict
for the non-movant and it is material if, under the substantive
law, it would affect the outcome of the suit. See id. at 248,
106 S.Ct. 2505. The moving
party must show that if the evidentiary material of record were
reduced to admissible evidence in court, it would be insufficient
to permit the non-moving party to carry its burden of proof. See
Celotex v. Catrett, 477 U.S. 317, 318, 106 S.Ct. 2548, 91
L.Ed.2d 265 (1986).
The party opposing a motion for summary judgment must set forth
specific facts showing a genuine issue for trial and may not rest
upon the mere allegations or denials of its pleadings. See Sound
Ship Bldg. Co. v. Bethlehem Steel Co., 533 F.2d 96, 99 (3d Cir.
1976), cert. denied, 429 U.S. 860, 97 S.Ct. 161, 50 L.Ed.2d 137
(1976). At the summary judgment stage the court's function is not
to weigh the evidence and determine the truth of the matter, but
rather to determine whether there is a genuine issue for trial.
See Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 249, 106
S.Ct. 2505, 91 L.Ed.2d 202 (1986). And, the court must construe
the facts and inferences in the light most favorable to the
non-moving party. See Wahl v. Rexnord, Inc. 624 F.2d 1169, 1181
(3d Cir. 1980).
Defendants, here, contend that certain claims of both patents
in suit are invalid because they were anticipated or rendered
obvious by prior art. 35 U.S.C. § 102(b) & 103. Since patent
claims are presumptively valid, 35 U.S.C. § 282, defendants must
advance clear and convincing evidence of invalidity in order to
succeed. See generally Intel Corp. v. United States Int'l Trade
Comm'n, 946 F.2d 821, 829 (Fed.Cir. 1991); Tyler Refrigeration
v. Kysor Indus. Corp., 777 F.2d 687, 690 (Fed. Cir. 1985).
A patent is invalid as anticipated if:
the invention . . . was described in a printed
publication in this or a foreign country . . . more
than one year prior to the date of the application
for the patent in the United States.
35 U.S.C. § 102(b). Under Section 102(b), inventions described in
a "printed publication" distributed over one year before the
initial patent application cannot be patented. The question of
whether a document is a printed publication is "a legal
determination based on underlying fact issues and, therefore,
must be approached on a case-by-case basis." In re Hall,
781 F.2d 897, 899 (Fed.Cir. 1986). A document "disseminated or
otherwise made available" "to persons concerned with the art to
which the document relates" is a "printed publication."
Massachusetts Inst. of Tech. v. AB Fortia, 774 F.2d 1104, 1109
(Fed. Cir. 1985); Carella v. Starlight Archery, 804 F.2d 135,
139 (Fed.Cir. 1986).
To invalidate an existing patent, a single prior publication
must contain all of the essential limitations of each claim;
there must be identity between the claimed process and a
process described in a prior art reference. See Glaverbel
Societe Anonyme v. Northlake Mktg. & Supply, Inc., 45 F.3d 1550,
1554 (Fed.Cir. 1995); Hybritech, Inc. v. Monoclonal Antibodies,
Inc., 802 F.2d 1367, 1379 (Fed. Cir. 1986). Defendants must show
that "each element of the claim in issue is found in a prior
patent or publication, either expressly or under principles of
inherency." Tyler Refrigeration v. Kysor Indus. Corp.,
777 F.2d 687, 689 (Fed.Cir. 1985); see also Celeritas Tech. Ltd. v.
Rockwell Int'l Corp., 150 F.3d 1354, 1360 (Fed.Cir. 1998);
Verdegaal Bros., Inc. v. Union Oil Co., 814 F.2d 628, 631-32
(Fed.Cir. 1987). Inherency occurs when the invention described by
the prior art necessarily functions in accordance with a claim
limitation, even if the limitation is not expressly mentioned in
the art. See generally Robert Harmon, Patents and the Federal
Circuit § 3.2 (4th ed. 1999).
Claim anticipation in prior art is a finding of fact. See
Titanium Metals Corp. v. Banner, 778 F.2d 775, 780-782 (Fed.Cir.
1985); Ecolochem, Inc. v. Southern California Edison Co.,
863 F. Supp. 1165, 1179 (C.D.Cal. 1994), aff'd in part, rev'd in
part, 91 F.3d 169 (Fed.Cir. 1996) ("Whether a [prior art]
each element of the claim is a question of fact."). Defendants'
motions, then, can only be granted if there are no genuine
disputes of material fact whether the processes described in any
one of the articles submitted anticipate the patents' claims.
The prior art need not present the invention in a positive
light, so long as all claims are explicitly or inherently
contained in the publication. See Celeritas, 150 F.3d at 1361
("A reference is no less anticipatory if, after disclosing the
invention, the reference then disparages it . . . . the question
of whether a reference `teaches away' from the invention is
inapplicable to an anticipation analysis."); see also Kalman v.
Kimberly-Clark Corp., 713 F.2d 760, 772 (Fed.Cir. 1983),
overruled on other grounds, SRI Intern. v. Matsushita Elec.
Corp., 775 F.2d 1107 (Fed.Cir. 1985) ("The law of anticipation
does not require that the reference `teach' what the subject
patent teaches."); Merck & Co. v. Mylan Pharm., Inc.,
19 F. Supp.2d 334, 345-46 (E.D.Pa. 1998); see generally Lance L.
Barry, Teaching A Way Is Not Teaching Away, 79 J. Pat. & Trade.
Off. Soc'y 867, 869 (1997) (a reference teaches away when "it
suggests that the line of development flowing from the
reference's disclosure is unlikely to be productive of the result
sought by the applicant."). The invention as disclosed by the
prior art, however, must be described so as to "enable" one
skilled in the art to (1) identify all claim limitations and (2)
create the invention.*fn1
Thus, anticipation analysis is a three-step process. The first
step is claim construction. The claims of the two patents in suit
are constructed in a companion opinion (the "Markman Opinion").
The second step requires the Court to compare the properly
constructed claims with the subject matter described in the prior
art reference and identify the elements disclosed in the
allegedly anticipating reference. The final step requires the
Court to determine whether the prior art placed the allegedly
disclosed matter in the possession of the public; the art must
enable one skilled in the art to produce the claimed
invention.*fn2 See, e.g., PPG Indus., Inc. v. Guardian Indus.
Corp., 75 F.3d 1558, 1566 (Fed.Cir. 1996).
Under 35 U.S.C. § 103, a patent is invalid:
though the invention is not identically disclosed or
described as set forth in section 102of this title,
if the differences between the subject matter sought
to be patented and the prior art are such that the
subject matter as a whole would have been obvious at
the time the invention was made to a person having
ordinary skill in the art to which said subject
Obviousness of a patent is a mixed question of law and fact. The
ultimate question of obviousness is one of law, based on certain
factual determinations. See In re Dance, 160 F.3d 1339, 1342
(Fed.Cir. 1998); Richardson-Vicks, Inc. v. Upjohn Co.,
122 F.3d 1476, 1479 (Fed.Cir. 1997). The primary
underlying factual determinations include: (1) the scope and
content of the prior art; (2) the level of ordinary skill in the
art; (3) the difference between the claimed invention and the
prior art; and (4) the extent of any proffered objective indicia
of nonobviousness. See Graham v. John Deere Co., 383 U.S. 1,
17-18, 86 S.Ct. 684, 15 L.Ed.2d 545 (1966). Objective indicia of
nonobviousness, called "secondary considerations" of obviousness,
include: (a) the invention's commercial success; (b) copying of
the invention; (c) a long felt need for the invention; (d)
failure of others to create the invention; and (e) unexpected
results. See In re Rouffet, 149 F.3d 1350, 1355 (Fed.Cir.
In this analysis, then, the Court must "look at the whole
invention rather than merely its different elements," and must
"step backward in time and into the shoes worn by a person of
ordinary skill in the art when the invention was unknown and just
before it was made." Boehringer Ingelheim Vetmedica, Inc. v.
Schering-Plough Corp., 68 F. Supp.2d 508, 530-31 (D.N.J. 1999).
The issue of whether the prior art "teaches away" from the
invention, then, is relevant. See generally Bausch & Lomb, Inc.
v. Barnes-Hind/Hydrocurve, Inc., 796 F.2d 443, 448 (Fed.Cir.
1986) (portions of a reference teaching away from claimed
invention should be considered when determining obviousness). In
addition, multiple references may be combined to render a patent
obvious where an artisan of ordinary skill would have known to
combine the various references. See In re Dance, 160 F.3d at
1342-43 (there must be "some suggestion, teaching, or motivation
[to combine] the prior art, arising from what the prior art would
have taught a person of ordinary skill in the field of the
A finding, however, that the patented invention may have been
"obvious to try" from the prior art will not invalidate it. Prior
art that makes the invention only "obvious to try" rather than
"obvious" "gives either no indication of which parameters are
critical or no direction as to which of many possible choices is
likely to be successful." Merck & Co. v. Biocraft Labs.,
874 F.2d 804, 807 (Fed.Cir. 1989). The correct standard is not
whether the invention would have been "obvious to try" but
whether one skilled in the art would have "a reasonable
expectation that the beneficial result will be achieved." In re
Merck & Co., 800 F.2d 1091, 1097 (Fed.Cir. 1986); see also
James Ruland, Chapter 2100 of the Manual of Patent Examining
Procedure — A Means For Persuasion, 6 Tex. Intell. Prop. L.J.
49, 54 (1997) ("the standard with which obviousness is determined
must be a reasonable expectation of success"). Thus, "absolute
predictability" is not required. Merck, 800 F.2d at 1097.
In 1986, an article by Mark G. Kris, et al. ("Kris article")
was published in a cancer journal. See Kris, et al., Phase I
of Taxol Given as a 3-Hour Infusion Every 21 Days, 70 Cancer
Treatment Reports 605-07 (1986). The seventeen patients in the
study described in the article were suffering from various solid
tumors. The trial was initiated at a dose of 15 mg/m² for three
hours, "[e]scalation proceeded using doses of 30, 45, 75, 100,
135, 160 and 230 mg/m² . . . . [p]atients who experienced no
drug-related toxicity were eligible to reenter the study at a
higher dosage level." Kris article at 606. Three patients, two
who received 190 mg/m² and one who received 230 mg/m², suffered
from "treatment-limiting hypersensitivity reactions" ("HSRs").
Id. None of the patients was premedicated to reduce HSRs. The
article noted that for those who received doses up to 190 mg/m²,
"leukopenia, thrombocytopenia, nausea and vomiting, alopecia,
stomatitis, transient rashes and hypersensitivity reactions were
observed. No anticancer effects were noted in this trial." Id.
at 607. The first paragraph of the article — essentially a
summary of the findings of the study — warned "[w]ith the
and unpredictability of the hypersensitivity reactions, further
usage of taxol is not indicated with this drug formulation on
this administration schedule." The final paragraph, however,
Hypersensitivity reactions constitute a severe and
unpredictable treatment-limitingtoxicity for the
present cremaphorcontaining formulation of taxolgiven
on this schedule. Further studies are needed to see
if pretreatment regimens, alternative schedules
[footnote to an article conducting a 24-hr. infusion
schedule], or a reformulated preparation will permit
the safe administration of this compound.
Id. at 607 (emphasis added). Bristol brought this article to
the attention of the United States Patent and Trademark Office
("USPTO") during prosecution.
An interim abstract of the Phase I study discussed in the Kris
article appeared in March 1985. See O'Connell, et al., Phase I
Trial of Taxol Given as a Three Hour Infusion Every Three Weeks,
26 Proceedings of the AACR 169 (No. 671) (March 1985). This
abstract ("O'Connell abstract") described the Kris article's
three-hour infusion/escalating dose schedule. The article stated
that "no antitumor effects were observed" but concluded "that for
doses up to 160 mg/m²: 1) Taxol can be safely given as a 3 ...