United States District Court, E.D. Pennsylvania
July 13, 2004.
BIOVAIL LABORATORIES, INC., Plaintiff
TORPHARM, INC., Defendant.
The opinion of the court was delivered by: ANITA BRODY, District Judge
MEMORANDUM AND ORDER
On September 3, 2002, plaintiff Biovail Laboratories, Inc.
["Biovail"] filed a complaint for patent infringement against
defendant Torpharm, Inc. ["Torpharm"]. In its complaint, Biovail
alleged that Torpharm infringed two of its patents: U.S. Patent
No. 5,529,791 [hereinafter "the `791 patent"] and U.S. Patent No.
5,288,505 [hereinafter "the `505 patent"] when Torpharm filed an
Abbreviated New Drug Application ("ANDA")*fn1 for Diltiazem
HC1 Capsules Type TZ (Diltiazem Hydrochloride Extended-Release
Capsules USP) 120mg, 180mg, 240mg, 300mg and 360mg. The
patents-in-suit involve extended release forms of Diltiazem, a
drug used to treat hypertension and angina.
On November 27, 2002, Torpharm moved for summary judgment,
arguing that its proposed ANDA product does not contain a "wetting agent" as
required by the claims of the patents-in-suit. (Def. Mot. Sum. J.
1.) Biovail responded to the motion for summary judgment on March
18, 2003, alleging that Torpharm's proposed ANDA product does
contain a "wetting agent" as defined by Biovail's patent, thereby
making Torpharm's proposed ANDA product an infringement of
Biovail's patent. On June 9, 2004 a hearing was held pursuant to
Markman v. Westview Instruments, Inc., 52 F.3d 967 (Fed. Cir.
1995) (en banc), aff'd, 517 U.S. 370 (1996). The parties
presented the court with a tutorial on their patents and proposed
constructions of the term "wetting agent."
RELEVANT LANGUAGE IN THE PATENTS-IN-SUIT
Claim 1 of `505 Patent:
An extended-release galenical composition of
Diltiazem or one or more pharmaceutically-acceptable
salts thereof, which comprises beads, said beads
consisting essentially of in admixture together: a)
an effective amount of Diltiazem or said one or more
salts thereof as an active ingredient, and b) an
effective amount of a wetting agent, wherein said
wetting agent is selected from the group consisting
of a sugar, a C12-C20 fatty acid ester of sucrose or
xylose, a glyceride of sucrose, a fatty acid ester of
polyoxyethylene, an ether of fatty alcohols and
polyoxyethylene, an ester of sorbitan, an ester of
polyoxyethylene sorbitan, a glyceridepolyglycide, an
alcohol-polyglycide ester, lecithins and a
-`505 Patent, Col. 9, Lines 5-13.
Claim 1 of `791 Patent:
An extended-release galenical composition of
Diltiazem or one or more pharmaceutically-acceptable
salts of Diltiazem which comprises beads containing an effective amount of one
or more of said Diltiazem salts as the active
ingredient, each bead containing one or more of the
Diltiazem salts and an effective amount of a wetting
agent in admixture with the one or more Diltiazem
salts to maintain the solubility of the Diltiazem in
each bead . . . wherein the wetting agent is selected
from the group consisting of sugars, C12-C20 fatty
acid esters of sucrose or xylose, glycerides of
sucrose or xylose, glycerides of sucrose, fatty acid
esters of polyoxyethylene, ethers of fatty alcohols
and polyoxyethylene, esters of sorbitan, esters of
polyoxyethylene sorbitan, alcohol-polyglycide esters,
glyceride-polyglycides, lecithins and a combination
-`791 Patent, Col. 9, lines 7-13.
PRINCIPLES OF CLAIM CONSTRUCTION
There are two stages in the litigation of patent infringement
cases. First, the court must determine the scope and meaning of
those patent claims disputed by the parties. Searfoss v. Pioneer
Consol. Corp., 2004 WL 1486822, 2004 U.S. App. LEXIS 13792 (Fed.
Cir. July 6, 2004). Second, the claims as construed by the court
are compared limitation by limitation to the features of the
allegedly infringing device. Id. The first step, often referred
to as "claim construction," typically occurs after a court
conducts a "Markman hearing," wherein the parties present
arguments for why the court should construe a claim a certain
way. The second step occurs at trial, after the court has issued
its decision on how the claims should be construed.
The "claim construction inquiry begins and ends in all cases
with the actual words of the claim." Searfoss (quoting
Teleflex, Inc. v. Ficosa N. Am. Corp., 299 F.3d 1313, 1324
(Fed. Cir. 2002).) "Absent an express intent to impart a novel
meaning to a claim term, the words take on the ordinary and
customary meaning attributed to them by those of ordinary skill
in the art." TI Group Auto. Sys. v. VDO N. Am., LLC, 2004 U.S.
App. LEXIS 13445 at *13 (Fed. Cir. June 30, 2004). "To determine the ordinary and customary meaning of a
claim term, we may review sources including the claims
themselves, dictionaries and treatises, and the written
description, drawings, and prosecution history." Id.
I will follow the sequence of analysis I adopted in Illinois
Tool Works, Inc. v. Ion Sys., Inc., 250 F. Supp.2d 477, 483
(E.D.Pa. 2003). In that case, I adopted the sequence proposed by
Magistrate Judge Mary Pat Thynge of the Delaware district court
in Tulip Computers, Internationali B.V. v. Dell Computer Corp.,
236 F. Supp.2d 364, 373 (D.Del. 2002), which recommended that the
court first "determine the ordinary and accustomed meanings of
disputed claim words through an examination of the relevant
dictionaries, encyclopedias, or treatises," in order to "reveal
the broadest definition of those terms as understood by one of
skill in the art." 236 F. Supp.2d at 373. Next, the court
"examine[s] the written description and prosecution history to
determine whether the full scope of the definition of a disputed
term is covered by the invention or whether that scope has
necessarily been limited as a result of the patentee clearly
setting forth an inconsistent definition of the disputed term or
otherwise disavowing or disclaiming the full scope of the term's
meaning." Id. This is done because, "[a]lthough words in a
claim are generally given their ordinary and customary meaning, a
patentee may choose to be his own lexicographer and use terms in
a manner other than their ordinary meaning, as long as the
special definition is clearly stated in the patent specification
or file history." Vitrionics Corp. v. Conceptronic, Inc.,
90 F.3d 1576, 1583 (Fed. Cir. 1996) (emphasis added.) By using this
procedure, the court "may avoid improperly importing claim
limitations to a single embodiment described in the specification
as might occur if the court begins its analysis with an
examination of the written description and prosecution history."
Tulip Computers, 236 F. Supp.2d at 373. CONSTRUCTION OF THE DISPUTED TERM
The parties have requested claim construction of the term
"wetting agent."*fn3 Pursuant to the structure laid out
above, I will first examine the definitions of "wetting agent" as
supplied by dictionaries and treatises, of which Torpharm has
submitted three in evidence. The definitions are as follows:
Wetting Agent: any of a group of surface-active
agents which, when added to a liquid, cause the
liquid to spread more easily over, or penetrate into,
a solid surface.
-WEBSTER'S NEW WORLD DICTIONARY OF THE AMERICAN
LANGUAGE 1616 (2d ed. 1980).
Wetting Agents are surface active substances that
are used to reduce the contact angle and therefore
-LEON LACHMAN ET AL., THE THEORY AND PRACTICE OF
INDUSTRIAL PHARMACY 120 (Lea & Fibiger 1970).
A Wetting Agent is a surfactant which, when
dissolved in water, lowers the advancing contact
angle and aids in displacing an air phase at the
surface and replacing it with a liquid phase.
-ALFRED N. MARTIN ET AL., PHYSICAL PHARMACY 437 (2d
Torpharm advocates that I adopt one of these dictionary
definitions as the definition of "wetting agent." On the other
hand, Biovail proposes that "wetting agent" be defined as "a
group consisting of a sugar, a C12-C20 fatty acid ester of
sucrose or xylose, a glyceride of sucrose, a fatty acid ester of polyoxyethylene, an ether of fatty alcohols
and polyoxyethylene, an ester of sorbitan, an ester of
polyoxyethylene sorbitan, a glyceride-polyglycide, an
alcohol-polyglycide ester, lecithins and a combination thereof."
In other words, Biovail reads the Markush group in the patents as
defining wetting agents.
Although these dictionary sources provide clear definitions of
"wetting agent," "the presumption in favor of a dictionary
definition will be overcome where the patentee, acting as his or
her own lexicographer, has clearly set forth an explicit
definition of the term different from its ordinary meaning."
Texas Digital, 308 F.3d at 1204. The "language of the claim
defines the boundary of its scope." Teleflex, Inc. v. Ficosa N.
Am. Corp., 299 F.3d 1313, 1324 (Fed. Cir. 2002). I therefore
turn to the language of the patents to determine whether it
provides an explicit definition of "wetting agent."
The language of the claims asks the reader to "select" a
wetting agent "from the group consisting of" several chemicals.
The language thus instructs the reader of the patent to do two
things: (1) select a wetting agent, and (2) do so from the list
provided. The reader should not understand the patent's language
to mean either that a wetting agent should simply be selected,
or, as Biovail would have the court read the language, that one
of the items in the Markush group should be selected irregardless
of whether it is a wetting agent. Both steps are necessary. Thus,
asking the reader to select a wetting agent from a list of
chemicals is not the same as defining the term wetting agent.
Rather, it is qualifying the term; to treat this usage as a
definition would be to severely alter the term's
meaning.*fn4 Biovail misinterprets the significance of a Markush group. In
support of its argument, Biovail cites to the MANUAL OF PATENT
EXAMINING PROCEDURE, § 2173.05(h), which, under the heading
"Markush Groups," provides that, "Alternative expressions [within
claims] are permitted if they present no uncertainty or ambiguity
with respect to the question of scope or clarity of the claims.
One acceptable form of alternative expression, which is commonly
referred to as a Markush group, recites members as being
"selected from the group consisting of A, B and C." This
statement goes no further than the already established
description of a Markush group in establishing whether listing a
group of chemicals as a Markush group is equivalent to providing
The patents' prosecution histories*fn5 do nothing to alter
my conclusion that Biovail's patent does not define "wetting
agent." I consider the prosecution histories "to determine
whether the patentee intended to deviate from a term's ordinary
and customary meaning or that the patentee disclaimed or
disavowed subject matter, narrowing the scope of the claim
terms." Nystrom v. Trex Co., Inc., 2004 WL 1432247 (Fed. Cir.
June 28, 2004). Biovail calls attention to three aspects of the
patents' prosecution histories: (1) The original applications for the `505 and `791
patents included the language about selecting a
wetting agent from "the group consisting of sugars/a
sugar." (Prosecution History of Patent No. 5,288,505
at 505-036; Prosecution History of Patent No.
5,529,791 at 791-040.)
(2) In the written description of the `505 patent
invention, under the heading "DETAILED DESCRIPTION OF
THE PREFERRED EMBODIMENTS," the `505 patent states:
"Among the wetting agents associated with the
Diltiazem or salt thereof in the beads, the following
compounds may more particularly be
exemplified:*fn6 sugars, for example,
saccharose, mannitol, soribitol, and lactose . . . In
addition to at least one of the above named wetting
agents the beads may contain excipients or carriers."
(Prosecution History of Patent No. 5,288,505 at
(3) In the `505 patent prosecution history, the
patentee explained that "wetting agents claimed in
the present invention are substances which are
believed to modify the solubility of Diltiazem inside
the coated beads when they are placed in a
dissolution medium or when they are ingested by a
mammal." (Prosecution History of Patent No. 5,288,505
The patent histories are consistent with the patents' language
and go beyond the patents' language in describing the role of the
wetting agent in the compound. However, Biovail has not provided
any evidence that the histories go farther than the plain
language of the patents in defining "wetting agent." Because I find that the language of the patents does not
"limit," "disavow," or "disclaim" the understood meaning of the
term "wetting agent," I will construe the claim as its "ordinary
and customary meaning." Illinois Tool, 250 F. Supp.2d at 484.
"[D]ictionary definitions may establish a claim term's ordinary
meaning." CCS Fitness, Inc. v. Brunswick Corp., 288 F.3d 1359
1366 (Fed. Cir. 2002). "If more than one dictionary definition is
consistent with the use of the words in the intrinsic record, the
claim terms may be construed to encompass all such consistent
meanings." Texas Digital, 308 F.3d at 1203. The parties do not
contend that the three proffered definitions taken from
dictionaries and treatises conflict with one another, and I see
no reason not to encompass all three definitions in my
construction. I therefore construe the term "wetting agent" as:
"any of a group of surface-active agents which, when added to a
liquid, reduce the contact angle and cause the liquid to spread
more easily over, or penetrate into, a solid surface."
The discussion and analysis presented above represents this
court's construction of the parties' disputed term. ORDER
AND NOW, this day of July 2004, upon consideration of the
briefs, exhibits, and oral argument presented by the parties in
conjunction with the Markman hearing in which they all
participated, it is hereby ORDERED that the meaning and scope
of the patent claim asserted to be infringed and presented by the
parties for construction is determined as set forth in the