United States District Court, E.D. Pennsylvania
March 14, 2003
ASTRAZENECA AB, et al.,
MUTUAL PHARMACEUTICAL CO., INC.
The opinion of the court was delivered by: MICHAEL BAYLSON, District Judge.
AstraZeneca AB (herein "Plaintiff") has brought this patent
infringement action against Mutual Pharmaceutical Company, Inc.
("Defendant").*fn1 Presently before this Court is Plaintiff's Motion
for Summary Judgment of Literal Infringement. For the reasons
which follow, Plaintiff's Motion will be granted.
I. Background and Procedural History
Plaintiff is the assignee of United States Patent 4,803,081
("the '081 patent"), which was issued on February 7, 1989. The
[250 F. Supp.2d 508]
patent contains 17 claims and relates to "extended release"
pharmaceutical preparations of active compounds having very low
solubility. One such compound with low solubility in the
intestines is felodipine, a cardiovascular drug, which Plaintiff
markets under the brand name Plendil.
On June 6, 2000, Defendant filed an Abbreviated New Drug
Application ("ANDA") seeking approval from the Food and Drug
Administration ("FDA") to manufacture and sell Defendant's
proposed 10 mg generic version of felodipine. See Plaintiff's
Memorandum in Support of its Motion for Summary Judgment of
Literal Infringement (herein "Pl. Brief"), Ex. 31 (Nov. 15, 2000
letter from Mutual to FDA). Defendant amended its ANDA twice, to
apply for approval of 5 mg and 2.5 mg dosages. See id.
Thereafter, on September 19, 2000, Plaintiff filed this patent
infringement suit, alleging that the proposed drug formulations
in Defendant's ANDA infringe the '081 patent. See
35 U.S.C. § 271(e)(2). Defendant counterclaimed, seeking declaratory
judgments that its proposed formulations would not infringe the
patent, and that the patent itself is invalid. On August 19,
2002, following a Markman hearing, this Court issued its
Conclusions of Law regarding the proper construction of the
patent claims at issue. Defendant then filed a motion for
reconsideration, which this Court denied on October 3, 2002. On
October 8, 2002, this matter was reassigned from the calendar of
Judge Lowell A. Reed Jr. to the undersigned.
On October 25, 2002, Plaintiff filed its Motion for Summary
Judgment of Literal Infringement. Defendant filed a brief in
opposition and Plaintiff filed a reply brief. On January 30,
2003, this Court heard oral argument on Plaintiff's motion, and
the parties have since submitted supplemental briefing.
II. The Law of Patent Infringement
The relevant statute makes it an act of patent infringement to
file an ANDA,
if the purpose of such submission is to obtain
approval [under the Food, Drug and Cosmetic Act] to
engage in the commercial manufacture, use, or sale of
a drug or veterinary biological product claimed in
[the] patent or the use of which is claimed in [the]
patent before the expiration of such patent.
35 U.S.C. § 271(e)(2). The remedies for this type of
infringement include injunctive relief against the Defendant's
commercial manufacture, use, or sale of the drug. See id
§ 271(e)(4). A court may also order that the effective date
of approval of the Defendant's new drug application be no earlier
than the expiration of the infringed patent. See id. Monetary
damages may not be awarded based on this type of infringement
unless the Defendant has already commercially made, used, sold or
offered to sell the drug. See id. Defendant admits that it filed
its ANDA with the purpose of eventually selling a generic version
of felodipine. See Defendant's Answer, Affirmative Defenses and
Counterclaim ¶¶ 12-14. Defendant further admits that its ANDA
contained a certification, as required by
21 U.S.C. § 355(j)(2)(A)(vii)(IV), declaring that Defendant's products
would not infringe the '081 patent. See id. The question thus
becomes whether the felodipine formulations described in
Defendant's ANDA were claimed in the '081 patent.
Courts follow a two-prong analysis in determining whether a
patent has been infringed. First, the court construes the scope
and meaning of the claims within the patent itself, as a matter
of law. See Markman v. Westview Instruments, Inc., 52 F.3d 967,
976-978 (Fed. Cir. 1995), aff'd 517 U.S. 370, 116 S.Ct. 1384,
134 L.Ed.2d 577
[250 F. Supp.2d 509]
(1996). Second, the court compares the claims of the patent to
the allegedly infringing product, to determine whether it
infringes the patent, either literally, or by equivalent parts.
See, e.g., id.
In the first step, to ascertain the meaning of the patent's
claims, the court must consider the language of the claims, the
patent's specification, and the prosecution history. See id. at
979. The court may also rely on extrinsic evidence, such as
dictionaries, learned treatises and expert testimony concerning
the interpretation that those skilled in the relevant art would
give to the claims. See id. at 980.
Terms within a patent claim must be interpreted according to
"their ordinary meaning to one of skill in the art unless it
appears from the patent and file history that the terms were used
differently by the inventors." Intellicall, Inc. v. Phonometrics,
Inc., 952 F.2d 1384, 1387 (Fed. Cir. 1992). As the Federal Circuit
has recently explained,
This heavy presumption in favor of the ordinary
meaning of claim language as understood by one of
ordinary skill in the art is overcome: (1) where the
patentee has chosen to be his or her own
lexicographer by clearly setting forth an explicit
definition for a claim term; or (2) where the term
chosen by the patentee so deprives the claim of
clarity that there is no means by which the scope of
the claim may be ascertained from the language used.
Prima Tek II, L.L.C. v. Polypap, S.A.R.L., 318 F.3d 1143
(Fed. Cir. 2003).
A patent's prosecution history consists of the public record of
proceedings in the Patent and Trademark Office ("PTO"). See
Markman, 52 F.3d at 980. Courts assess whether an inventor waived
coverage of certain subject matter based on the totality of the
prosecution history, including both claim amendments and
arguments made to the PTO. See Rheox, Inc. v. Entact, Inc.,
276 F.3d 1319, 1326 (Fed. Cir. 2002). The prosecution history can
only limit claim language where the inventor surrendered coverage
"with reasonable clarity and deliberateness." Schumer v.
Laboratory Computer Systems, Inc., 308 F.3d 1304, 1313 (Fed. Cir.
In the second step of the two-prong process, the court compares
the elements of the patent claims to the allegedly infringing
product. The general rule is that a patent claim covers an
accused device if that device embodies every element of the
claim, either literally or by an equivalent element. See, e.g.
Carroll Touch, Inc. v. Electro Mechanical Systems, Inc.,
15 F.3d 1573, 1576 (Fed. Cir. 1993); Mannesmann Demag Corp. v. Engineered
Metal Products, 793 F.2d 1279, 1282 (Fed. Cir. 1986). Plaintiff
in the instant case is proceeding on a theory of literal
infringement. To succeed, Plaintiff "must show that the accused
device contains every limitation in the asserted claims. . . . If
even one limitation is missing or not met as claimed, there is no
literal infringement." Mas-Hamilton Group v. LaGard, Inc.,
156 F.3d 1206, 1211 (Fed. Cir. 1998). See also Mannesmann, 793 F.2d at
1282. Though this infringement question is typically for the fact
finder, see id., it becomes amenable to summary judgment where
the parties do not dispute any relevant facts regarding the
accused product, see, e.g., General Mills, Inc. v. Hunt-Wesson,
Inc., 103 F.3d 978, 983 (Fed. Cir. 1997), or when the Court finds
"no genuine issue as to any material fact" for trial.
Fed.R.Civ.P. 56(c). An issue is "genuine," under Rule 56(c), if
the evidence is such that a reasonable jury could return a
verdict for the non-moving party. Anderson v. Liberty Lobby,
Inc., 477 U.S. 242, 248, 106 S.Ct. 2505, 91 L.Ed.2d 202 (1986).
[250 F. Supp.2d 510]
A party seeking summary judgment always bears the initial
responsibility for informing the district court of the basis for
its motion and identifying those portions of the record that it
believes demonstrate the absence of a genuine issue of material
fact. Celotex Corp. v. Catrett, 477 U.S. 317, 322,
106 S.Ct. 2548, 91 L.Ed.2d 265 (1986). Where the non-moving party bears the
burden of proof on a particular issue at trial, the moving
party's initial burden can be met simply by "pointing out to the
district court that there is an absence of evidence to support
the non-moving party's case." Id. at 325, 106 S.Ct. 2548. After
the moving party has met its initial burden, "the adverse party's
response, by affidavits or as otherwise provided in this rule,
must set forth specific facts showing that there is a genuine
issue for trial." Fed.R.Civ.P. 56(e). Summary judgment is
appropriate if the non-moving party fails to rebut by making a
factual showing "sufficient to establish the existence of an
element essential to that party's case, and on which that party
will bear the burden of proof at trial." Celotex, 477 U.S. at
322, 106 S.Ct. 2548. Under Rule 56, the Court must view the
evidence presented on the motion in the light most favorable to
the opposing party. Anderson, 477 U.S. at 255, 106 S.Ct. 2505.
III. Step One Claim Construction
This Court has already completed the first step of the patent
infringement analysis. See Conclusions of Law Regarding Patent
Claim Construction (Aug. 19, 2002) (herein "Conclusions of Law").
In his August 19, 2002 opinion, Judge Reed ruled as to the
meanings of several terms used in claims 1, 8, 12, 14, 15 and 17
of the '081 patent the only claims at issue in this
litigation. See id. at 1. Most of the terms interpreted by Judge
Reed appear in claim 1 of the patent. Claims 2 through 16 are
dependent on claim 1, which contains the following limitations:
1. A solid preparation providing extended release of
an active compound with very low solubility in water
comprising a solution or dispersion of an effective
amount of the active compound in a semi-solid or
liquid nonionic solubilizer, wherein the amount by
weight of the solubilizer is at least equal to the
amount by weight of the active compound, and a
release controlling system to provide extended
United States Patent 4,803,081 (issued Feb. 7, 1989) (emphasis
A. This Court's Claim Construction
1. Basic Terminology
In his Conclusions of Law Judge Reed construed the term
"extended release," throughout the patent, as meaning "releasing
the active ingredient from the dosage form over time in a manner
that reduces the dosage frequency as compared to immediate
release dosage forms." Conclusions of Law at 21. The Court
interpreted the terms "solution or dispersion" and "dissolving or
dispersing" according to their ordinary meanings, such that "a
solution or dispersion is the dispersed or dissolved substance(s)
and the medium in which it is dispersed or dissolved." Id. at 23.
Next, the Judge interpreted "hydrophilic gel system," appearing
in claim 12 of the patent, to mean "a delivery system of a
water-soluble gel- and matrix-forming material." Id. at 24.
Finally, the Court construed the term "pharmaceutical dosage
unit," in claim 17, as meaning simply a dosage form, such as a
tablet or capsule, containing a dose of a drug. Id. at 25.
2. "Nonionic Solubilizer"
The bulk of Judge Reed's opinion, however, concerned the term
"nonionic solubilizer." The parties have not disputed the
[250 F. Supp.2d 511]
meaning of "nonionic." See Conclusions of Law at 10. Providing
more than ten pages of reasoning and support, the Court held that
"solubilizer," throughout the patent, should be interpreted
according to its "ordinary" meaning: a compound "that increases
the solubility of a substance in a particular solvent." Id. at
Significantly, Judge Reed found that the ordinary meaning of
"solubilizer" includes both "surfactants" and "co-solvents."
Conclusions of Law at 10, 14, 19. Whether "solubilizer" in the
patent includes co-solvents is important in this litigation, as
Defendant's formulations allegedly include one particular
co-solvent, polyethylene glycol 400 (herein "PEG 400").*fn2 See Pl.
Brief, Ex. 20 (ANDA excerpt). Prior to Judge Reed's opinion,
Defendant contended that "solubilizer" should be read to include
surfactants, but not co-solvents. Defendant asserted that, in
prosecuting the '081 patent, the inventor had waived co-solvents,
such as PEG 400, as appropriate solubilizers for use in the
invention disclosed in the patent.
Judge Reed considered the prosecution history, the patent
specification and other intrinsic evidence, and found that the
inventor had not clearly disavowed non-surfactant solubilizers.
See Conclusions of Law at 19. While Judge Reed did not explicitly
conclude that "solubilizer" within the patent covers the
co-solvent PEG 400, he found that "solubilizer" does include
co-solvents, generally.*fn3 Of course, any particular co-solvent,
such as PEG 400, can only be considered a solubilizer, within a
given device, if it functions as a solubilizer when it interacts
with other components in that device. Thus, under Judge Reed's
claim construction, the patent covers any co-solvent, within a
particular drug formulation, if that co-solvent would function as
a solubilizer within that formulation. Whether PEG 400 functions
as a solubilizer in Defendant's products will be considered infra
in Part IV.B.1.
3. The Kawata Patent
Judge Reed also considered Defendant's argument that the
inventor of the '081 patent disclaimed certain subject matter
covered by a prior art patent, referred to herein as the "Kawata
patent." See United States Patent 4,673,564 (issued June 16,
1987) (inventors, Hiroitsu Kawata, et al.). Defendant argued
during claim construction that Plaintiff was only able to obtain
the '081 patent by distinguishing the '081 patent's subject
matter from Kawata.
The Kawata patent relates to "a sustained release
pharmaceutical composition of a solid medical material." Id.
(col.1, ln.17). Specifically, one object of the Kawata invention
was to provide a sustained release pharmaceutical composition of
the drug nicardipine, which has low solubility in the intestines.
See id. (col. 2, lns. 14-16; col. 3, ln. 42). The Kawata
invention is a process by which a solid medical material (i.e.
nicardipine) is compounded with polyethylene oxide and at least
one "basic substance" the "first component" such
as, for example, hydroxypropylmethyl cellulose. Id. (col.1,
lns.50-56). Kawata also
[250 F. Supp.2d 512]
teaches an optional second basic substance, the "second
component." See id. (col.1, lns.66-68). Kawata suggests, only by
way of example, that the second component may be a surfactant
(also known as a "surface active agent"), or polyethylene glycol
(i.e. PEG 400). See id. (col. 2, ln. 1; col. 5; ln. 65).
It is important to note that the Kawata patent actually teaches
against the use of solubilizers. See id. (col.3, lns.49-52). As
Kawata explains, the inventors "found that a sustained release
pharmaceutical composition of nicardipine can be obtained by
using amorphous nicardipine without adding any substance
improving the solubility in the intestines." Id. Thus, although
examples of the second component include surfactants and PEG 400,
Kawata's process does not make use of these substances as
solubilizers. Earlier in this litigation, at a Markman hearing,
Judge Reed "specifically asked defendant to show where in the
Kawata patent PEG 400 was used as a solubilizer. Defendant
responded by directing the court to Example 2 and highlighting
that PEG 400 is used; however, Mutual never explained how it is
used as a solubilizer." Conclusions of Law at 16-17 (citation to
Kawata describes a process in which the medical material and
the first component (and, optionally, the second component) are
dissolved in a volatile solvent such as ethanol, "singly or in
combination," and then the volatile solvent is removed by drying.
See id. (col.2, ln.24-30). The result is a fine powder in which
the medical material is dissolved "uniformly in amorphous form in
the basis substance(s)." See id. (col.2, lns.33-36). Finally,
polyethylene oxide is mixed with the fine powder, resulting in a
sustained release pharmaceutical composition. See id. (col.2,
Defendant has placed great emphasis on the fact that Kawata
lists PEG 400 as an example of the optional second component.
Defendant argued before Judge Reed that, in order to obtain the
'081 patent, Plaintiff disavowed the use of PEG 400, and other
non-surfactant solubilizers, thereby limiting the '081 patent to
surfactant type solubilizers. In response, Plaintiff argued that
no such disclaimer had occurred, because Kawata and the '081
patent involve entirely different processes altogether.
Specifically, Plaintiff contended, Kawata does not describe using
PEG 400 as a solubilizer, and actually teaches against the use of
solubilizers. See Conclusions of Law at 17-18. Rather, Plaintiff
asserted that, in Kawata, the function of PEG 400 is to aid in
Kawata's "co-precipitation" process, not to serve as a
solubilizer. Id. at 16.
Based upon a thorough consideration of the Kawata patent and
the prosecution history of the '081 patent, Judge Reed found that
Plaintiff had not clearly disavowed non-surfactant solubilizers,
such as PEG 400. See id. at 19. The Court held as follows:
[T]he prosecution history indicates that Astra did
not distinguish its patent from Kawata (1) on the
ground of a particular solubilizer because not only
does Kawata use an entirely different process, but
the specification teaches against solubilizers; and
(2) the claims do not require surfactant type
solubilizers because Kawata discloses both
surfactants and co-solvents as possibilities for the
optional second component. It is further noted that
Astra points out that nowhere in the prosecution
history did Astra define nonionic solubilizer as
excluding PEG 400. I therefore conclude that the
prosecution history does not limit the claim term
nonionic solubilizer beyond its ordinary meaning.
Judge Reed's opinion resolved several important issues
regarding the '081 patent
[250 F. Supp.2d 513]
and Kawata. These conclusions can be summarized as follows: 1.)
The '081 patent and Kawata use entirely different processes; 2.)
the inventor of the '081 patent distinguished Kawata as an
entirely different process; 3.) whereas the '081 patent requires
a solubilizer, Kawata specifically teaches against the use of any
component in Kawata (i.e. PEG 400) as a solubilizer; 4.) the
inventor of the '081 patent distinguished Kawata on the ground
that Kawata teaches against solubilizers; 5.) Kawata discloses
both surfactants and co-solvents (i.e. PEG 400) as possibilities
for the optional second component; and 6.) in distinguishing
Kawata, the inventor of the '081 patent could not have waived
co-solvents (thereby limiting the '081 patent to surfactants)
because Kawata discloses both surfactants and co-solvents. See
id. at 15-19.
Despite Judge Reed's comprehensive consideration of the Kawata
disclaimer issue during claim construction, Defendant now, at the
summary judgment stage, raises new arguments relating to Kawata
and the prosecution history of the '081 patent.
B. Defendant's New Claim Construction Argument
Now, following Judge Reed's claim construction, in response to
Plaintiff's motion for summary judgment, Defendant raises a new
issue of claim interpretation, concerning the following phrase
within claim 1 of the patent: "a solution or dispersion of an
effective amount of the active compound in a semi-solid or liquid
nonionic solubilizer." Defendant's new position is that the word
"in" should be construed to mean "in and only in." Defendant's
Memorandum in Opposition to Plaintiff's Motion for Summary
Judgment ("Def.Brief") at 6. Defendant contends that, under the
proper interpretation of "in," the patent is limited to a
solution in which an effective amount of the active compound is
dissolved in and only in the solubilizer, and in nothing else.*fn4
This is significant, Defendant claims, because in Defendant's
formulations, the active compound felodipine is "intermixed" with
not only PEG 400 (which may or may not function as a
solubilizer), but also with one or more additional substances,
such as ethanol (a volatile solvent) or polyvinyl pyrrolidone
("povidone" or "PVP"). Id. at 1. Defendant stresses that, in its
formulations, the felodipine, the PEG 400, and various other
components (i.e. ethanol and PVP) are all mixed together into a
"homogenous composition," which is then dried. See id. at 7.
Thus, Defendant argues, in its products the felodipine and the
PEG 400 "are never intermingled in the absence of another
component." Id. Under Defendant's suggested interpretation of the
word "in," the '081 patent would cover only formulations in which
an "effective amount" of the active compound is entirely
dissolved or dispersed in the nonionic solubilizer alone.
Defendant highlights two statements made by the inventor in an
amendment filed with the PTO. Defendant claims that these two
statements prove the inventor limited its invention to a
formulation in which the active compound is entirely dissolved in
a solubilizer only, and not in any third substance. See Def.
Brief at 6. Both of these statements were apparently made in
attempting to distinguish the invention of the '081 patent from
the prior art Kawata patent. As explained above, Kawata teaches a
"first component" and an optional
[250 F. Supp.2d 514]
"second component;" the second component can be, as an example,
PEG 400. Though PEG 400 can be used, generally, as a solubilizer,
the Kawata patent specifically teaches that solubilizers should
not be used. See supra Part III.A.3.
The first statement at issue was made in relation to a May 11,
1988 claim amendment, in response to an initial rejection by the
PTO based, in part, on Kawata's prior art. See Def. Brief, Ex. F.
The inventor sought to distinguish Kawata by demonstrating that
Kawata does not even make use of solubilizers, at least not in
any appreciable amount. See id. at 5, lns. 7-11, 19-21. The
inventor pointed out, to the PTO, that Kawata teaches against
using any "substance improving the solubility in the intestines."
Id. (quoting Kawata, United States Patent 4,673,564 (col.3,
lns.49-52)). Of course, the use of a solubilizer is a major
element in the '081 patent. Thus, the inventor argued, Kawata
"provides no guidance toward the present invention." See id.,
The inventor also argued, in the alternative, that even if the
second component in Kawata were used as a solubilizer, the active
compound would be "principally" dissolved in the first
Only one component of [Kawata's] formulations could
be a "nonionic solubilizer" . . . i.e. Kawata's
optional 2nd component of the basic substance. Even
if the drug in Kawata's formulations can be said to
be dissolved or dispersed, however, it is not in the
2nd component alone, but principally in the required
1st component of the basic substance.
Id., Ex. F at 4-5. Defendant wishes to lift this remark out of
context, to show that, in order to overcome Kawata, the '081
patent's inventor limited its coverage to solutions in which the
active compound is dissolved entirely in the solubilizer, and not
also in something else. More specifically, Defendant suggests
that because Kawata describes a solution in which an active
compound is mingled with several different components (including
a volatile solvent), the '081 patent's inventor was compelled to
disclaim any solution in which the active compound is not
dissolved 100-percent in the solubilizer alone. This Court is
satisfied that the inventor made no such disclaimer.
The inventor's remarks to the PTO were seemingly made in the
context of distinguishing Kawata as an entirely different
process, in that Kawata did not even utilize solubilizers. The
inventor set forth an alternative argument that, even if Kawata
used solubilizers, the active compound would not be "principally"
in the solubilizer. All that the inventor conceded was that, if
Kawata contains a solubilizer as its second component, the Kawata
active compound is principally dissolved in the first component,
not the solubilizer. That is entirely different from a wholesale
disclaimer of all solutions in which the active compound is
dissolved in both a solubilizer and another substance, such as a
volatile solvent. Accordingly, the prosecution history excerpt
relied upon by Defendant does not clearly establish that the
inventor surrendered coverage "with reasonable clarity and
deliberateness," with respect to solutions in which the active
compound is not 100-percent dissolved in the solubilizer alone.
Schumer, supra, 308 F.3d at 1313.
Defendant cites a second passage from the same claim amendment
filed with the PTO, which Defendant claims establishes a
disclaimer of "volatile solvents." In the amendment, the inventor
asserted that "manufacture of the preparations of the invention
does not involve the use of volatile solvents as does Hegasy
[another prior art patent]." Def. Brief, Ex. F, at 8, lns. 16-17.
This statement, on its face, demonstrates a limited disclaimer,
only in that
[250 F. Supp.2d 515]
the '081 patent does not incorporate volatile solvents.
The disclaimer of volatile solvents is consistent with
Plaintiff's position, throughout the prosecution and throughout
this litigation, that the Kawata patent is distinguishable as an
entirely different process from the '081 patent. Just as the
inventor pointed out to the PTO that Kawata does not use
solubilizers, the inventor also pointed out that Kawata utilizes
volatile solvents, whereas the '081 patent does not. But the
inventor never told the PTO that the '081 patent should exclude
all preparations in which a volatile solvent is used at all.
Claim 1's express limitation, "in a semisolid or liquid
nonionic solubilizer" applies to all solutions in which the
active compound is dissolved or dispersed in a nonionic
solubilizer. The specification and prosecution history do not
suggest that a narrower interpretation should apply. Thus, an
accused formulation will meet this claim element even though the
alleged infringer has also added to the accused formulation some
extra ingredients, such as PVP or a volatile solvent like
ethanol. Cf. Mannesmann, supra, 793 F.2d at 1283 ("The presence
of additional elements is irrelevant if all the claimed elements
are present in the accused structure."); A.B. Dick Co. v.
Burroughs Corp., 713 F.2d 700, 702 (Fed. Cir. 1983) ("It is
fundamental that one cannot avoid infringement merely by adding
elements if each element recited in the claims is found in the
As noted above, courts interpret claim language with a "heavy
presumption" in favor of the "ordinary meaning" of terms. Prima
Tek, supra, 318 F.3d 1143, 1147-48. Defendant has failed to cite
any case law justifying a conclusion that the preposition "in" is
synonymous with the phrase "in and only in;" as every college
student studying logic knows, they are not considered
Defendant cites Key Pharmaceuticals v. Hercon Laboratories
Corp., 161 F.3d 709 (Fed. Cir. 1998), in which the Federal Circuit
construed the term "pharmaceutically effective amount." However,
the Key Pharmaceuticals decision pertains to a patent for a
transdermal adhesive patch, not an oral pharmaceutical
formulation. After reviewing the facts and analysis in Key
Pharmaceuticals, this Court is convinced that that case is
totally inapposite to the question before this Court, i.e.,
whether the '081 patent, which is limited to an "effective
amount" of the active compound "in" a solubilizer, can cover only
solutions in which the active compound is totally dissolved in
the solubilizer alone.
Likewise, Defendant relies on Hazani v. U.S. Intern. Trade
Com'n, 126 F.3d 1473 (Fed. Cir. 1997), in which the court
construed the phrase "integrally formed in":
Although the term "integrally formed in" is not
defined in the written description portion of the
specification, the word "integral" means "complete"
or "entire," and the word "in," as used in this
context, means "indicating a point or place thought
of as spatially surrounded or bounded." See Webster's
New International Dictionary 1253, 1290 (2d ed.
Hazani has not given us any reason to depart from the
ordinary meaning of those words. Accordingly, the
term "integrally formed in," as used in claim 14,
requires that the bit line be formed entirely within
Id. at 1480. Hazani is irrelevant to the instant case not only
because it involved a semiconductor memory cell technology
bearing no comparison to the invention of the '081 patent, but
also because the Hazani court interpreted the word "in" within
[250 F. Supp.2d 516]
the context of the larger phrase "integrally formed in."
In sum, the intrinsic evidence presented to this Court with
respect to the '081 patent does not suggest, as Defendant
contends, that the word "in" must be read as "in and only in."
Def. Brief at 6. Nothing in the patent or prosecution history
suggests that the patent can only cover solutions in which the
active compound is dissolved in and only in the solubilizer, and
in nothing else. Nor does the intrinsic evidence cited by
Defendant prove that an accused product can escape infringement
simply because it includes a third ingredient (such as ethanol or
PVP), intermixed with the active compound and solubilizer.
IV. Step Two Infringement
Plaintiff moves for summary judgment on the issue of literal
infringement, with respect to five claims in the '081 patent:
claims 8, 12, 14, 15 and 17.
A. Sources of Plaintiff's Infringement Evidence
Plaintiff contends that its evidence of infringement need not
exclusively rely on chemical or pharmacological properties of the
various ingredients, but can also rely on admissions made by
Defendant in various circumstances. In this Court's opinion, the
evidence of infringement can include the chemical and
pharmacological analysis, but can also include admissions of
The first alleged admissions are the statements which Defendant
made in its ANDA. Although these might not necessarily be
characterized as "admissions," they are clearly the Defendant's
statements and they are probative as to whether Defendant's
product infringes on Plaintiff's patent. The cases are well
established that statements in the ANDA can be used to determine
whether the product specified in the ANDA will infringe an
existing patent. See, e.g., Abbott Laboratories v. TorPharm,
Inc., 300 F.3d 1367, 1373 (Fed. Cir. 2002) (stating that "an ANDA
specification defining a proposed generic drug in a manner that
directly addresses the issue of infringement will control the
infringement inquiry"). The details concerning statements made in
Defendant's ANDA are reviewed infra in Part IV.B.
It is perhaps obvious, but relevant to note, that Defendant has
not sold any of its generic felodipine products, and therefore
there cannot be any chemical analysis based on Defendant's actual
products in the stream of commerce. Therefore, the analysis must
be confined to Defendant's written description of the product it
proposes to sell, as well as Defendant's statements in support of
the ANDA and in other proceedings. The Federal Circuit has
explained that, where an infringement claim is premised upon the
defendant's filing of an ANDA, the court must focus its
infringement inquiry "on what is likely to be sold following FDA
approval" of the defendant's proposed product. Glaxo, Inc. v.
Novopharm, Ltd., 110 F.3d 1562, 1568 (Fed. Cir. 1997). As the
Court of Appeals noted, "this hypothetical inquiry is properly
grounded in the ANDA application and the extensive materials
typically submitted in its support," as well as "other pertinent
evidence provided by the parties." Id. at 1569-70. The Federal
Circuit has also recently observed that if the defendant's ANDA
"defines a property of a compound such that it must meet a
limitation of an asserted claim, then there will almost never be
a genuine dispute of material fact that the claim is infringed
with respect to that limitation." Abbott, 300 F.3d at 1373.
[250 F. Supp.2d 517]
2. Deposition of Defendant's Officer
In addition to the ANDA itself, Plaintiff has also submitted
the deposition testimony of Dr. Spiro Spireas, Ph.D., Defendant's
Vice President of Research and Development. Defendant argues that
Dr. Spireas's testimony was not on behalf of Defendant, but only
in his personal capacity. See Def. Brief at 14. As the deposition
was taken pursuant to Rule 30(b)(6), it is quite obviously the
deposition of the Defendant itself and can be used against the
Defendant. See Fed.R.Civ.P. 30(b)(6) (requiring deponent
organization to designate officers, directors or other persons
"who consent to testify on its behalf"); Resolution Trust Corp.
v. Farmer, Civ.A. No. 92-3310, 1994 WL 317458, at *1 (E.D.Pa.
June 24, 1994) (noting "purpose behind Rule 30(b)(6) is to create
testimony that will bind the corporation.").
Dr. Spireas is not only Defendant's Vice President of R &
D, but also was directly involved in the development of
Defendant's felodipine formulations. See Pl. Brief, Ex. 46
(deposition transcript), at 379-80. In the deposition, he
referred to himself as the "father figure" of the felodipine
formulations. Id. at 380. In its deposition notice, Plaintiff
informed Defendant that the subjects of the deposition would
include the "development of the formulation of each of Mutual's
Proposed Generic Felodipine Products," as well as the
"properties, uses, functions or performance of each component of
each of the Proposed Generic Felodipine Products." Pl. Brief, Ex.
48 (notice). Accordingly, Dr. Spireas's deposition testimony
regarding Defendant's accused products may properly be considered
admissions of Defendant.
3. Product Development Reports
Plaintiff has also submitted three Mutual internal product
development reports ("PDR"s), authored by Defendant's product
development personnel, including Dr. Spireas. Defendant created
one PDR for each dosage of its anticipated generic felodipine
product. The two PDRs related to Defendant's 2.5 mg and 5 mg
dosages were based largely on the 10 mg PDR, and incorporated
that PDR by reference. See Pl. Brief, Ex. 13, at M037421; Ex. 14,
Defendant contends that the statements in its PDRs amount to
"mere conjecture, hypothesis and theory," and cannot constitute
"evidence" as to the nature of Defendant's final products. See
Defendant's Supplemental Memorandum in Opposition to Plaintiff's
Motion (herein "Def. Supp.") at 19. As Dr. Spireas explained in
his deposition, the PDRs contain a "comprehensive discussion of
all the issues, all of the major, if you will, issues that were
involved in the development of this product." Pl. Brief, Ex. 46,
at 379-80. Moreover, the PDRs themselves explain that the
"target" of Defendant's product development was the submission of
an ANDA for generic felodipine tablets in 10, 5 and 2.5 mg
dosages. Id., Ex. 9, at M036583.
To rebut any relation between the PDRs and Defendant's ultimate
product, Defendant refers to the contents of its PDRs as mere
"hypothesis," as to the nature or properties of Defendant's
formulations. Def. Brief at 15 (citing Def. Brief, Ex. H (10 mg
PDR), at M036588). Defendant has not explained why the PDRs would
have been written if they did not relate specifically to the
felodipine products developed by Defendant. Accordingly, in
deciding the present summary judgment motion, this Court will
consider any statements contained in Defendant's PDRs, along with
all other evidence submitted.
4. Judicial Admissions
Plaintiff also relies on certain other statements which are in
the nature of judicial
[250 F. Supp.2d 518]
admissions, being statements made by Defendant's counsel in the
proceedings before Judge Reed. Judicial admissions "are
admissions in pleadings, stipulations, etc. and which do not have
to be proven in the same litigation." Giannone v. U.S. Steel
Corp., 238 F.2d 544, 547 (3d Cir. 1956).
Plaintiff contends that Defendant's counsel admitted, earlier
in this litigation, that its product contains every element of
the patent's claims, except for one element the "nonionic
solubilizer." For instance, at an October 12, 2001 hearing,
Defense counsel told the Court, "[w]e don't dispute that we have
all the other claim elements in the patent claim. So the defense
from an infringement standpoint is really just that, the
non-ionic solubilizer that's claimed in the patent can't cover
the PEG-400." See Pl. Brief, Ex. 4 (Transcript), at 112-13. Also,
in an October 5, 2001 letter to Judge Reed, Defense counsel
advised the Court that "the only contested issue for decision on
the subject of infringement is the following: Whether PEG 400 [a
component of Defendant's products] is a `solubilizer' as this
claim term is properly construed in view of the plain language of
the claim, the specification and the prosecution history." See
id., Ex. 21, at 2. Defendant asserts that its statements should
not be considered because their counsel was merely advocating
Defendant's position on the claim construction issues, and it
would not be fair to hold the statements of counsel in that
context against Defendant in the infringement context. Generally,
to be binding, judicial admissions must be "unequivocal." Glick
v. White Motor Co., 458 F.2d 1287, 1291 (3d Cir. 1972). Moreover,
as the Third Circuit has pointed out, in a non-patent context,
the scope of judicial admissions is "restricted to matters of
fact which otherwise would require evidentiary proof, and does
not include counsel's statement of his conception of the legal
theory of a case." Id. This Court believes the statements by
Defendant's counsel were more than legal contentions, and, thus,
may be considered along with the other evidence. See, e.g.,
Zapach v. Dismuke, 134 F. Supp.2d 682, 693 (E.D.Pa. 2001)
(finding defendant's admissions in deposition conclusive as to
facts admitted); Loral Fairchild Corp. v. Victor Co. of Japan,
Ltd., 911 F. Supp. 76, 81 (E.D.N.Y. 1996) (holding plaintiff was
estopped from changing its patent infringement theory following
discovery, where plaintiff had consistently maintained a
different position on liability from outset of litigation).
The Court need not decide whether it would rest infringement on
judicial admissions alone, because, in this case, the judicial
admissions follow and are consistent with the statements made by
Defendant's representatives in a deposition and in the ANDA
itself. Thus, although the Court believes it does not have to
rely on judicial admissions alone, because there is a consistency
throughout the evidence, the judicial admissions may be
considered along with the other evidence.
B. Comparison on Defendant's Proposed Products to the '081 Patent
As explained above, a patent claim covers an accused device if
that device embodies every element of that claim. See, e.g.,
Carroll Touch, 15 F.3d at 1576. Claims 8, 12, 14 and 15 of the
'081 patent are dependent on claim 1, whereas claim 17 claims the
process of the invention. Although Plaintiff does not here assert
infringement of claim 1, see Pl. Brief at 2, this Court must
nevertheless determine whether Defendant's products contain every
element of claim 1, in order to decide whether Defendant has
infringed dependent claims 8, 12, 14 and 15.
[250 F. Supp.2d 519]
1. Claim 1 of the '081 Patent
Claim 1 comprises "a solution or dispersion of an effective
amount of the active compound in a semi-solid or liquid nonionic
solubilizer, wherein the amount by weight of the solubilizer is
at least equal to the amount by weight of the active compound,
and a release controlling system to provide extended release."
United States Patent 4,803,081. This Court must determine whether
each of the three elements of claim 1 is present in the accused
a. "A solution or dispersion of an effective amount of the active
compound in a semi-solid or liquid nonionic solubilizer"
To be effective as a drug, felodipine needs to get through the
intestine. The parties agree that felodipine is insoluble in
water. The use of a "solubilizer," together with an extended
release mechanism, helps to get felodipine through the intestine
and into the bloodstream. As noted above, Judge Reed, in
construing the claims, held that "solubilizer" should be given
its ordinary meaning, including surfactant and co-solvents.
Defendant argued during claim construction that the '081 patent
only covers surfactants, and that PEG 400, which is a co-solvent,
not a surfactant, does not qualify as a solubilizer. Because
Judge Reed held that a non-ionic solubilizer, as claimed by
Plaintiff, includes all types of solubilizers, including
co-solvents, this Court holds that PEG 400, a co-solvent used by
Defendant, can function as a solubilizer.
Defendant seemingly does not dispute that its formulations
contain an active compound, felodipine, which is "in solution."
Def. Brief at 9. Nevertheless, Defendant contends that, in its
products, the active compound is not dissolved in any chemical
which functions as a solubilizer in Defendant's products.
Moreover, Defendant's position is that, even if PEG 400 functions
as a solubilizer in Defendant's formulations, the active compound
is not exclusively dissolved "in and only in" that solubilizer.
Id. at 6.
(1.) Evidence Presented By Plaintiff on the "Solubilizer" Claim
Defendant's manufacturing process undeniably involves the use
of liquid PEG 400. See Pl. Brief, Ex. 20 (excerpt from ANDA); Ex.
26 at M002574. Moreover, Defendant's ANDA itself states that PEG
400 is used as a "solubilizer" in Defendant's products. See Pl.
Brief, Ex. 20. The ANDA includes several Unit and Batch
Composition charts, relating to Defendant's proposed felodipine
dosages. In each of these charts, the left column lists the
components of Defendant's proposed formulations, while the right
column states the "function" of the corresponding ingredient.
Right across from PEG 400, each chart simply reads
The testimony of Dr. Spireas also lends support to the
conclusion that PEG 400 is a solubilizer in Defendant's products.
Doctor Spireas was asked about certain experiments he had
performed, involving felodipine. Dr. Spireas characterized PEG
400 as a "cosolvent solubility enhancer" with respect to these
experimental formulations. Pl. Brief, Ex. 46 (deposition
transcript), at 324, lns. 8-13. At another point, he described
PEG 400 as a "cosolvent, which happens to be a solubility
[250 F. Supp.2d 520]
which happens to be a nonvolatile solvent." Id. at 333, lns.
24-25. Elsewhere, the witness explained that PEG 400 "increases
the solubility of water-insoluble drugs in water." Id. at 335,
As discussed above, Judge Reed determined that the term
"nonionic solubilizer" in the '081 patent should be read
according to its ordinary meaning, i.e., a nonionic compound
"that increases the solubility of a substance in a particular
solvent." Conclusions of Law at 19. Dr. Spireas, as the R & D
officer who developed Defendant's accused formulations,
acknowledged, at least tacitly, that the function of PEG 400 is
to increase the solubility of felodipine in water. Therefore, Dr.
Spireas's testimony is strong evidence suggesting that the PEG
400 in Defendant's products is indeed a solubilizer.
Finally, Defendant's product development reports explain that
the "nonvolatile solvent," PEG 400 "would enhance by a cosolvency
principle the solubility of felodipine." Pl. Brief, Ex. 9, at
M036587. The PDRs also reveal that, in the felodipine
formulations developed by Defendant, the drug is "already in
solution in the nonvolatile solvent," PEG 400. Id. at M036588.
Moreover, Defendant's internal laboratory research documents
confirm that, in Defendant's manufacturing process, the
felodipine "goes into solution" when it is introduced into a
mixture of PEG 400 and ethanol. See Pl. Brief, Ex. 26, at
(2.) Defendant's Evidence and Arguments
In support of its position that the active compound in the
accused formulations is not dissolved "in" the PEG 400, Defendant
has submitted two expert affidavits. See Def. Supp., Exs. H and
I. In the first affidavit, James A Ibers, Ph.D., states that he
studied samples of Defendant's felodipine products using X-ray
diffraction techniques. See id., Ex. H. ¶ 11. Per the
expert's observations, no felodipine "crystals" were present in
Defendant's formulations; rather the felodipine was in
"amorphous" form. Id. ¶ 15. The affidavit of Dr. Natalie
Lazarowych is based on her analysis of scanning electron
micrographs and light micrographs performed on Defendant's
formulations. See id., Ex. I ¶ 7. The expert stated that, in
her opinion, "the location of the felodipine could not be
determined." Id. ¶ 9. Further, in the expert's view, "it
could not be determined if the felodipine was dissolved or
dispersed in PEG 400." Id.
As set forth above, Plaintiff has submitted numerous admissions
by Defendant, which affirmatively demonstrate that the felodipine
is dissolved in the PEG 400 in the accused products. Accordingly,
under Fed.R.Civ.P. 56(e), Defendant must come forward with at
least some evidence suggesting that the felodipine is not
dissolved in a solubilizer. The two affidavits submitted merely
state that, in the experts' views, it cannot be determined
whether or not the felodipine is in the PEG 400. These affidavits
also suggest, vaguely, that the felodipine appeared to be in
"amorphous" form. Defendant's expert affidavits fail to reach any
definite conclusion whatsoever. By contrast, Plaintiff has
positively shown that the felodipine formulations, which
Defendant intends to market, would contain an active compound
dissolved in PEG 400, acting as a solubilizer.
Aside from its affidavit evidence, Defendant again raises an
argument as to "disclaimer." Defendant stresses that it cannot be
infringing the '081 patent because it is merely following the
co-precipitation process described in the prior art Kawata
patent, which Defendant still urges the inventor
of the '081 patent disclaimed entirely.
[250 F. Supp.2d 521]
As explained above, the inventor did not disclaim the entire
subject matter taught in Kawata; rather, the inventor only
distinguished the '081 patent from Kawata, as a totally unrelated
process. See supra Parts III.A.3 and B. Although the inventor
seemingly disclaimed volatile solvents because volatile
solvents are not a component of the '081 patent that does
not mean that the inventor disclaimed all preparations in which a
volatile solvent is intermixed along with the active compound and
solubilizer. See Part III.B, supra. Moreover, although the
inventor distinguished Kawata as not contemplating a solubilizer
element, that does not mean that the inventor disclaimed all
solutions in which the active compound is not 100-percent
dissolved in a solubilizer, and in nothing else. See supra id.
While it is true that Defendant's process and the Kawata
process share certain common components, Defendant uses PEG 400
as a solubilizer, whereas Kawata specifically teaches against the
use of any component as a solubilizer. See Conclusions of Law at
17-18. On that ground alone, Defendant's process departs from the
technique disclosed in Kawata. Moreover, even assuming that
Defendant's products and process in fact follow Kawata to the
letter, the mere fact that an accused infringer is "practicing
the prior art" does not preclude a finding of literal
infringement. Tate Access Floors, Inc. v. Interface Archil.
Resources, Inc., 279 F.3d 1357, 1365 (Fed. Cir. 2002). Though a
prior art patent would certainly be relevant to a claim of patent
invalidity, it can be no defense to infringement an
entirely separate determination. See id. at 1367.
Additionally, Defendant highlights the fact that it first mixes
ethanol with the PEG 400, before dissolving the felodipine. But
this cannot free Defendant's formulations from the '081 patent's
coverage. The '081 patent is not limited to solutions in which
the active compound is dissolved "in and only in" the
solubilizer, and in nothing else. See Part III.B, supra.
Moreover, all of the ethanol Defendant uses is evaporated during
the manufacturing process. As Defendant's ANDA explains, ethanol
(denatured alcohol) does "not appear in the final product." Pl.
Brief, Ex. 20, at M002933. Defendant's PDRs also state that
ethanol "does not appear in the final product." Id., Ex. 9, at
M036600. Thus, even if it may be said that the felodipine is
dissolved partially in both the ethanol and PEG 400, the ethanol
is entirely dried off during Defendant's process, making it
impossible for any felodipine to remain dissolved in ethanol in
the final formulations.
Finally, Defendant claims that some of the statements contained
in the PDRs and the deposition of Dr. Spireas pertain not to
Defendant's products, but rather, to a separate technology called
"LiquiSolid" systems, for which Dr. Spireas himself holds a
number of patents. Def. Supp. at 18. However, as explained in the
PDRs, Defendant's formulations were "based on" LiquiSolid systems
and the use of PEG 400 as a "carrier/cosolvent." Pl. Brief, Ex.
9, at M036587. The purpose of the PEG 400 in Defendant's products
is to "enhance by a cosolvency principle the solubility of
felodipine." Id. Therefore, even if Defendant could successfully
distinguish LiquiSolid systems from Defendant's ultimate
products, Defendant cannot disprove the use of PEG 400 as a
solubilizer in those ultimate products.
(3.) Presence of the "Solubilizer" Element in Defendant's
At oral argument defense counsel asserted that a genuine issue
of fact for trial existed as to whether Defendant's product is
dissolved in a substance that fits with Judge Reed's definition
of a solubilizer. Defense counsel (See Transcript of Oral
Argument Hearing (Jan. 30, 2003) at 46-47) asserted that, in
[250 F. Supp.2d 522]
the active compound is dissolved differently than in the '081
patent. Defendant claims that it dissolves the active compound
(felodipine) in ethanol, which is not a solubilizer. Felodipine
is well known to be fully soluble in alcohol. Defendant asserts
that its product does not infringe the patent because at no point
during Defendant's process does the felodipine and PEG 400 come
into intimate contact with each other alone, in the absence of
other substances. Defense counsel asserted that, therefore,
Defendant's process is so different from the Plaintiff's process,
that it creates an issue of fact as to whether Defendant's
process is covered by Judge Reed's definition of the Plaintiff's
claim. Thus, Defendant asserts that, even assuming PEG 400 is a
solubilizer, the manner in which Defendant uses it does not make
Defendant's product infringe the patent.
Defendant's counsel's argument must be rejected. First, as
noted above, the affidavits which Defendant has submitted do not
fully support the argument of counsel. Second, defense counsel's
argument is contradicted by the many statements by Defendant,
reviewed above, that demonstrate that felodipine is dissolved in
PEG 400 in the Defendant's product. Lastly, Judge Reed's
definition of a solubilizer is justifiably broad enough to cover
Defendant's use of PEG 400. Assuming arguendo that Defendant
dissolves the active compound first into the ethanol, the fact
that Defendant uses PEG 400 as a solubilizer in which to
dissolve the felodipine to any extent warrants a
conclusion that Defendant's products contain an active compound
which is dissolved or dispersed in a nonionic solubilizer.
b. "Wherein the amount by weight of the solubilizer is at least
equal to the amount by weight of the active compound"
Next, the patent requires that the amount by weight of the
solubilizer be at least equal to the amount by weight of the
active compound. Defendant's ANDA and PDRs reveal that, in the
allegedly infringing formulations, the solubilizer PEG 400
outweighs the active compound, felodipine, by 4.5 times, 9 times,
or 18 times, depending on the drug dosage. See id., Exs. 20 and
31 (ANDA excerpts); Ex. 14, at M037112. This meets the
weight-ratio limitation of claim 1.
c. "A release controlling system to provide extended release"
Finally, claim 1 requires a "release controlling system to
provide extended release." Judge Reed construed the term
"extended release," throughout the patent, as meaning "releasing
the active ingredient from the dosage form over time in a manner
that reduces the dosage frequency as compared to immediate
release dosage forms." Conclusions of Law at 21. Defendant's ANDA
reveals that the accused formulations contain hydroxypropyl
methylcellulose (herein "HPMC"), the function of which is to
provide extended release. See id., Exs. 20 and 31 (ANDA
excerpts). Defendant's PDRs also list this ingredient as an
extended release agent. See id., Ex. 14, at M037112. Accordingly,
this final element of claim 1 is present in Defendant's products.
Therefore, Plaintiff has met its burden of proving that
Defendant's products encompass every element of claim 1.
2. Claim 8 of the '081 Patent
Claim 8 reads, in its entirety: "A preparation according to
claim 1 wherein the active compound comprises one or more
substituted dihydropyridines." U.S. Patent 4,803,081. Because
claim 8 refers to the preparation set forth in claim 1, claim 8
must be construed as including all of
[250 F. Supp.2d 523]
claim 1's limitations, in addition to the limitation that the
active compound must comprise one or more substituted
dihydropyridines. The cardiovascular drug felodipine is
undisputedly a dihydropyridine. See Pl. Brief, Ex. 5 (Parties'
Joint General Glossary of Technical Terms). The active compound
in Defendant's formulations is felodipine. See Pl. Brief, Ex. 20.
Accordingly, the dihydropyridine element of claim 8 is met. This
Court has found supra that Defendant's products infringe claim 1.
Hence, there remains no genuine issue of material fact as to
Defendant's infringement of claim 8.
3. Claim 12 of the '081 Patent
Claim 12 covers "[a] preparation according to claim 1 wherein
the release is controlled by a hydrophilic gel system." U.S.
Patent 4,803,081. As explained above, this Court has interpreted
the term hydrophilic gel system to mean "a delivery system of a
water-soluble gel- and matrix-forming material." Conclusions of
Law at 24. Plaintiff suggests that hydroxypropyl methylcellulose
(HPMC), which is used in Defendant's products as an extended
release agent, is a hydrophilic gel system. Defendant's ANDA
states that one function of HPMC is "Matrix Forming Agent." P1.
Brief. Ex. 20. Defendant's PDRs refer to HPMC as an "extended
release and matrix forming agent." Id., Ex. 9, at M03660; Ex. 13,
at M037426; Ex. 14, at M037112. Defendant has offered no evidence
to show that this claim element is absent from its products.
Therefore, there is no genuine issue of material fact as to
Defendant's infringement of claim 12.
4. Claim 14 of the '081 Patent
Claim 14 covers "[a] preparation according to claim 12 wherein
the hydrophilic gel system comprises hydroxypropyl
methylcellulose." U.S. Patent 4,803,081. As explained above,
hydroxypropyl methylcellulose (HPMC) is used in Defendant's
formulations as a hydrophilic gel system. Therefore, summary
judgment of infringement is appropriate as to claim 14.
5. Claim 15 of the '081 Patent
Claim 15 covers "[a] preparation according to claim 14 wherein
the hydroxypropyl methylcellulose has a hydroxypropyl content of
4-12% by weight." U.S. Patent 4,803,081. Plaintiff has submitted
a Mutual internal report to demonstrate that the hydroxypropyl
methylcellulose (HPMC) used in Defendant's formulations has a
hydroxypropyl content, by weight, of between seven and twelve
percent. See Pl. Brief, Ex. 29. Plaintiff also points to a
scientific paper authored by Dow Chemical Company to show that
the HPMC used in Defendant's products has a hydroxypropyl
percentage between seven and twelve percent. See id., Ex. 15, at
8. Defendant has not attempted to rebut these proofs. Therefore,
there is no genuine issue of material fact that Defendant's
products infringe claim 15.
6. Claim 17 of the '081 Patent
Claim 17 describes the process of the invention taught in the
17. A process for making a solid preparation that
provides extended release of an active compound with
very low solubility in water comprising
dissolving or dispersing an effective amount of the
active compound in a semi-solid or liquid nonionic
solubilizer, the amount by weight of said solubilizer
being at least equal to the amount by weight of the
active compound, and
incorporating the resulting solution or dispersion
into a suitable release controlling system to form a
pharmaceutical dosage unit.
[250 F. Supp.2d 524]
U.S. Patent 4,803,081. The process described in claim 17 involves
two steps: dissolving or dispersing the active compound in a
nonionic solubilizer; then, incorporating the resulting solution
or dispersion into a suitable "release controlling system" to
form a pharmaceutical dosage unit.
Defendant's process involves each of the elements involved in
these two steps. In its ANDA, Defendant includes a Manufacturing
Process Flowchart, relating to its felodipine products. The first
step described in this chart is mixing together ethanol and PEG
400. See Pl. Brief, Ex. 26. The very next step is to add
felodipine into that mixture, then stir for eight minutes. See
id. Subsequent steps involve adding povidone (PVP) and other
substances into the total composition. Yet, per this Court's
claim construction, the inclusion of ethanol, PVP or some other
ingredient in Defendant's composition cannot negate the fact that
the felodipine goes into solution with the PEG 400. Defendant's
process also requires mixing the resulting solution with HPMC,
which Defendant's own documents refer to as an "extended release
agent." See Pl. Brief, Exs. 20 and 27. Defendant has not
submitted evidence specifically rebutting Plaintiff's evidence of
infringement as to claim 17. Accordingly, summary judgment is
C. Defendant's products infringe the '081 patent.
Defendant finally contends that Plaintiff has conducted "no
technical analysis on Mutual's tablets," and therefore cannot
prove that those tablets embody the elements of the '081 patent.
Def. Supp. at 13. Courts do not require an inventor to physically
test an accused product, or produce the defendant's device, to
establish infringement. See, e.g., Allen Archery, Inc. v.
Browning Mfg. Co., 819 F.2d 1087, 1098 (Fed. Cir. 1987). Rather,
this Court may decide the present motion for summary judgment
based on the numerous admissions relied on by Plaintiff. See Fed.
R.Civ.P. 56(c) (permitting court to consider "admissions" in
deciding summary judgment motion). See also Penederm Inc. v.
Alzo, Inc., No. Civ.A. 95-1222, 1996 WL 724766, at *3 (N.D.Cal.
1996) (stating that defendant's "own representations about the
accused composition may sufficiently demonstrate that the
composition meets the elements of the claims").
As shown in Part IV.B, supra, Defendant's formulations embody
every element of claims 1, 8, 12, 14, 15 and 17. This Court has
compared Defendant's proposed products, component by component,
with the elements of the '081 patent's claims, and concludes that
no genuine issue of material fact remains as to whether Defendant
has infringed the patent.
Plaintiff has met its burden of demonstrating the absence of a
genuine issue of material fact, as to whether Defendant's
proposed formulations infringe claims 8, 12, 14, 15 and 17 of the
'081 patent. Defendant has not countered Plaintiff's evidence
with "specific facts showing that there is a genuine issue for
trial." Fed.R.Civ.P. 56(e). Accordingly, this Court shall enter
summary judgment of literal infringement.
An appropriate Order follows.
AND NOW, this ___ day of March, 2003, it is hereby ORDERED that
the Plaintiffs' Motion for Summary Judgment of Literal
Infringement is GRANTED.
For purposes of scheduling proceedings on Defendant's
counterclaim, counsel shall
[250 F. Supp.2d 525]
confer on a schedule providing for dispositive motions and, if
necessary, a trial, this calendar year. A telephone conference
with counsel is scheduled for Tuesday, March 25th at 5:00 p.m.
Plaintiff's counsel will initiate the call, and when all parties
are on the line, call Chambers at 267.299.7520.