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ASTRAZENECA AB v. MUTUAL PHARMACEUTICAL CO.
August 19, 2002
ASTRAZENECA AB, ET AL., PLAINTIFFS,
MUTUAL PHARMACEUTICAL COMPANY, INC. DEFENDANT.
The opinion of the court was delivered by: Lowell A. Reed, Jr., Senior District Judge.
CONCLUSIONS OF LAW REGARDING PATENT CLAIM CONSTRUCTION
Plaintiffs, Aktiebologet Hassle, KBI-E Inc., KBI Inc.,
AstraZeneca AB, and AstraZeneca LB, (collectively referred to as
"Astra" or "plaintiffs") filed this patent infringement suit
against defendant Mutual Pharmaceutical Company, Inc. ("Mutual"
or "defendant"), alleging that under 35 U.S.C. § 271(e)(2),
Mutual is infringing United States Patent No. 4,803,081 ("the
'081 patent"), by filing its Abbreviated New Drug Application
("ANDA") seeking approval from the Federal Drug Administration
("FDA") to manufacture, use and sell Mutual's proposed
Felodipine 10 mg, 5mg, and 2.5mg tablets products as generic
versions of plaintiffs' products. The '081 patent is entitled
"New Pharmaceutical Preparations With Extended Release," and
deals with pharmaceutical extended release preparations of
active compounds with very low solubility. In total, the
following six claims of the '081
patent are at issue in this lawsuit: 8, 12, 14, 15 and
A Markman hearing was held on April 30, 2002, in which the
parties presented oral argument as to the proper construction of
the disputed claim language in the claims at issue. The parties
also submitted a series of briefs, deposition transcripts and
proposed claim constructions to the Court, all of which were
considered by this Court in making the claim constructions that
follow. On each claim term to be construed, the parties have
submitted many arguments and have pointed to many portions of
the intrinsic and extrinsic record in their briefs, proposed
claim constructions, and oral presentations. While the Court has
considered all of the arguments and citations of the parties, I
may not reiterate all of them in full for each claim term.
I. THE LAW OF PATENT CLAIM CONSTRUCTION
In general, a patent must describe the scope of the patentee's
invention so as to "secure to [the patentee] all to which he is
entitled, [and] to apprise the public of what is still open to
them." Markman v. Westview Instruments, Inc., 517 U.S. 370,
373, 116 S.Ct. 1384, 134 L.Ed.2d 577 (1996) (internal quotation
omitted) (alteration in original). This is accomplished through
the specification of the patent, which should describe the
invention in clear terms so that a person of ordinary skill in
the art of the patent may make and use the invention, and the
claims of the patent, which should "particularly point out and
distinctly claim the subject matter which the applicant
regards as his invention."*fn2 35 U.S.C. § 112.
In Markman, the Supreme Court, affirming the Court of
Appeals for the Federal Circuit, held that construction of
patent claims is exclusively within the province of the court to
determine as a matter of law. 517 U.S. at 372, 116 S.Ct. 1384.
To complete the task of claim construction, a court may draw on
the canons of construction that can be sifted from the decisions
of the Court of Appeals for the Federal Circuit spanning before
Markman and beyond. In construing the claims of a patent, a
court should consider the claim language, the specification,
and, if offered, the prosecution history, which are collectively
considered intrinsic evidence of the meaning of the claim terms.
See Markman v. Westview Instruments, Inc., 52 F.3d 967, 979
(Fed.Cir. 1995). As the public record before the United States
Patent and Trademark Office ("PTO") upon which the public is
entitled to rely, the intrinsic evidence is the most important
source for determining the meaning of claim terms. See
Vitronics Corporation v. Conceptronic, Inc., 90 F.3d 1576,
1582-83 (Fed.Cir. 1996). Under some circumstances, a court may
also consult evidence extrinsic to the patent, such as technical
dictionaries or expert testimony, to interpret the claims. See
id. at 1583.
Claim construction begins by looking to the claim language
itself to define the scope of the patent. See Bell Atlantic
Network Services, Inc. v. Covad Comm. Group, Inc.,
262 F.3d 1258, 1267
(Fed.Cir. 2001). A technical term used in a patent is construed
as having "the meaning a person of ordinary skill in the field
of the invention would understand it to mean." Id. Unless
otherwise compelled, a court should give full effect to the
ordinary meaning of claim terms, even if the terms are broad.
See Johnson Worldwide Assoc., Inc. v. Zebco Corporation,
175 F.3d 985, 989 (Fed.Cir. 1999). The ordinary meaning of a term
may be established through dictionary definitions. See CCS
Fitness, Inc. v. Brunswick Corp., 288 F.3d 1359, 1366 (Fed.Cir.
2002). "General descriptive terms will ordinarily be given their
full meaning; modifiers will not be added to broad terms
standing alone." Johnson Worldwide, 175 F.3d at 989. Where the
claim language is clear on its face, the remaining intrinsic
evidence is considered only to determine whether a deviation
from that clear definition is specified. See Interactive Gift
Express, Inc. v. Compuserve Inc., 256 F.3d 1323, 1331 (Fed.Cir.
2001). Where the language lacks clarity, then the remaining
intrinsic evidence is viewed for resolving that ambiguity. See
After examining the words of the claim, the court is directed
to turn to the specification to determine whether any terms have
been used in a manner which is inconsistent with the ordinary
meaning. See Vitronics, 90 F.3d at 1582. While terms are
generally given their ordinary meaning, "[c]laims must be read
in view of the specification, of which they are a part."
Markman, 52 F.3d at 979; see also Phonometrics, Inc. v.
Northern Telecom Inc., 133 F.3d 1459, 1466 (Fed.Cir. 1998)
("Although claims are not necessarily restricted in scope to
what is shown in a preferred embodiment, neither are the
specifics of the preferred embodiment irrelevant to the correct
meaning of claim limitations."). The relationship between the
claims and the specification it illustrated by the following
pair of claim construction canons: "(a) one may not read a
limitation into a claim from the written description, but (b)
one may look to the written description to define a term already
in a claim limitation, for a claim must be read in view of the
specification of which it is a part." Renishaw PLC v. Marposs
Societa' per Azioni, 158 F.3d 1243, 1248 (Fed.Cir. 1998). At
times, the line between reading a claim in light of its
specification and reading a limitation into the claim from the
specification is a fine one. See Interactive Gift, 256 F.3d at
1331. Thus, this Court is mindful that the specification is
examined to discern the meaning of the claim as used by the
patentee in the context of the entire invention and not merely
to narrow the claim. See id.
While additional limitations may not be imported into a claim
from the specification, a court may construe a limitation
specifically recited in a claim in light of the specification.
See Phonometrics, 133 F.3d at 1466. Thus, in order to inject a
definition into a claim from the written description, the claim
must explicitly contain a term in need of definition. See
Renishaw, 158 F.3d at 1248, 1252 (noting that passages
referring to the preferred embodiment cannot be read into the
claim without some "hook"). Further, claim terms should not be
narrowed by the content of the specification "unless the
language of the claims invites reference to those sources."
Johnson Worldwide, 175 F.3d at 990 (noting that there "must be
a textual reference in the actual language of the claim with
which to associate a proffered claim construction").
Where the specification is used to redefine the meaning of a
particular term, the intrinsic evidence must "`clearly set
forth'" or "`clearly redefine'" the term in such a way that one
reasonably skilled in the art is on notice that the patentee
intended such redefinition. Bell Atlantic, 262 F.3d at 1268
(quoting Elekta Instr. v. O.U.R. Scientific Int'l,
214 F.3d 1302, 1307 (Fed.Cir. 2000); N. Telecom,. Samsung,
215 F.3d 1281, 1287 (Fed.Cir. 2000)). The written description must
demonstrate an "`express intent to impart a novel meaning' to
claim terms." Id. (quoting Schering Corp. v. Amgen Inc.,
222 F.3d 1347, 1353 (Fed.Cir. 2000); Optical Disc Corp. r. Del Mar
Avionics, 208 F.3d 1324, 1334 (Fed.Cir. 2000)). Cf. Johnson
Worldwide, 175 F.3d at 991 (term used in a variety of ways in
specification may be indicative of breadth of term rather than a
As to the second situation which may overcome a presumption
that the term be construed to have its ordinary meaning, while a
court generally construes claim terms consistent with their
common meaning, a "common meaning, such as one expressed in a
relevant dictionary, that flies in the face of the patent
disclosure is undeserving of fealty." Renishaw, 158 F.3d at
1250. Also, a court may resort to the specifications if a claim
term lends itself to several common meanings; in such a
situation "the patent disclosure selves to point away from the
improper meanings and toward the proper meaning." Id.
This Court is also instructed to view the prosecution history
to determine whether "the patentee has relinquished a potential
claim construction in an amendment to the claim or in an
argument to overcome or distinguish a reference." Bell
Atlantic, 262 F.3d at 1268. This history encompasses the entire
record of all proceedings before the PTO, including express
representations made by the patentee regarding the scope of the
patent, as well as prior art cited therein which may give clues
as to what the claims do not cover. See id.; Vitronics, 90
F.3d at 1582-83. Thus this information can be of "critical
significance" in construing the claims. Vitronics, 90 F.3d at
As with the specification, however, "[a]lthough the
prosecution history can and should be used to understand the
language used in the claims, it too cannot `enlarge, diminish,
or vary' the limitations in the claims." Markman, 52 F.3d at
980 (quoting Goodyear Dental Vulcanite Co. v. Darvis,
102 U.S. 222, 227, 12 Otto 222, 26 L.Ed. 149 (1880)). A caveat: If a
patentee takes a position before the PTO, such that a
"competitor would reasonably believe that the applicant had
surrendered the relevant subject matter," the patentee may be
barred from asserting an inconsistent position on claim
construction. Cybor Corp. v. FAS Tech., Inc., 138 F.3d 1448,
1457 (Fed.Cir. 1998); see also Cole v. Kimberly-Clark Corp.,
102 F.3d 524, 531 (Fed. Cir. 1996) (holding that patentee was
estopped from arguing that her "perforation means" encompassed
"ultrasonic bonded seams" after she distinguished references
that contained such seams). If a patentee distinguishes a
reference on multiple grounds to the PTO, any one of these may
indicate the correct construction of a term. See Gentry
Gallery, Inc. v. Berkline Corp., 134 F.3d 1473, 1477 n. *
(Fed.Cir. 1998). However, "[u]nless altering claim language to
escape an examiner['s] rejection, a patent applicant only limits
claims during prosecution by clearly disavowing claim coverage,"
that is, by making a statement that concedes or disclaims
coverage of the claims at issue based on a piece of prior art.
York Products, Inc. v. Central Tractor Farm & Family Ctr.,
99 F.3d 1568, 1575 (Fed.Cir. 1996).
If the claims can be construed from the intrinsic evidence
alone, it is not proper to rely on extrinsic evidence "other
than that used to ascertain the ordinary meaning of the claim
limitation." Bell Atlantic, 262 F.3d at 1258. In the rare
circumstance that the court is not able to construe the claims
after examining the intrinsic evidence, however, it may turn to
extrinsic evidence to resolve any ambiguity. See id. Extrinsic
evidence includes expert testimony, articles and testimony of
the inventor. See id. As with the intrinsic evidence,
extrinsic evidence may not be used to "vary, contradict, expand,
or limit the claim language from how it is defined, even by
implication, in the specification or file history." Id. It is
also proper to consult extrinsic evidence for the purpose of
understanding the underlying technology. See Interactive Gift,
256 F.3d at 1332.
Dictionaries and technical treatises, while they are
technically extrinsic to the patent, hold a "special place" and
in certain situations may be considered along with intrinsic
evidence when determining the ordinary meaning of claim terms.
Bell Atlantic, 262 F.3d at 1267. See also Dow Chem. Co. v.
Sumitomo Chem. Co., Ltd., 257 F.3d 1364, 1372 (Fed.Cir. 2001);
Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1584 n. 6
(Fed.Cir. 1996) ("Judges are free to consult such resources at
any time in order to better understand the underlying technology
and may also rely on dictionaries definitions when construing
term claims, so long as the dictionary definition does not
contradict any definition found in or ascertained by a reading
of the patent documents."). Courts are warned, however, against
using non-scientific dictionaries, "`lest dictionary definitions
. . . be converted into technical terms of art having legal, not
linguistic significance.'" Sumitomo, 257 F.3d at 1372.
II. CONSTRUCTION OF THE CLAIMS
The claims here presented to the Court for construction may be
categorized into the following groups: (1) Nonionic solubilizer
(Claims 1, 8, 12, 14, 15 and 17); (2) Extended release (Claims
1, 8, 12, 14, 15 and 17); (3) A solution or dispersion of an
effective amount of the active compound; and dissolving or
dispersing an effective amount of the active compound (Claims 1,
8, 12, 14, 15 and 17); (4) hydrophilic gel system (Claims 12, 14
and 15); and (5) pharmaceutical dosage unit (Claim 17).
Astra argues that claim 10 is also asserted in this
litigation. Mutual contends that Astra never identified this
claim during fact discovery. (Astra's Final Answer to Mutual's
Interrogatories Nos. 1, 5 and 7, Def.'s Ex. E at 3-10.) Astra
brings forth no argument as to why this Court should allow Astra
to pursue a claim which Astra does not deny was excluded ...