Shire LLC et al v. Mylan Pharmaceuticals Inc. et al

Filing 173

MEMORANDUM OPINION and Order Construing Patent Claims. Signed by District Judge Irene M. Keeley on 1/14/13. (jss)

IN THE UNITED STATES DISTRICT COURT
FOR THE NORTHERN DISTRICT OF WEST VIRGINIA
SHIRE LLC, SUPERNUS
PHARMACEUTICALS, INC.
Plaintiffs,
v.

//

CIVIL ACTION NO. 1:11CV55
LEAD CASE
(Judge Keeley)

MYLAN PHARMACEUTICALS INC.
and MYLAN INC.,
Defendants.

SHIRE LLC, SUPERNUS PHARMACEUTICALS,
INC., SHIRE DEVELOPMENT INC.
Plaintiffs,
v.

//

CIVIL ACTION NO. 1:11CV201
MEMBER CASE
(Judge Keeley)

MYLAN PHARMACEUTICALS INC.
and MYLAN INC.,
Defendants.

MEMORANDUM OPINION AND ORDER CONSTRUING PATENT CLAIMS
This patent infringement case involves two United States
Patents

issued

to

the

plaintiffs,

Shire

L.L.C.,

Supernus

Pharmaceuticals, Inc., and Shire Development, Inc. (“Shire”),
specifically U.S. Patent Nos. 6,287,599 (“the ‘599 patent”), and
6,811,794 (“the ‘794 patent”) (collectively, the “patents-insuit”). Shire uses the pharmaceutical compositions and methods
described in these patents to produce INTUNIV®, an extended-

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release,

guanfacine-based

drug

for

treating

Attention

Deficit

Hyperactivity Disorder (“ADHD”). Currently pending before the Court
is the construction of two disputed terms or phrases found in the
asserted claims of the patents-in-suit. After careful consideration
of the parties’ submissions and the arguments at the Markman
hearing,1 the Court construes the disputed terms as follows.
I.

BACKGROUND

In a letter dated February 8, 2011, Mylan notified Shire that
it had filed an Abbreviated New Drug Application (“ANDA”) seeking
United States Food and Drug Administration (“FDA”) approval to
market a generic version of the 4 mg dosage form of INTUNIV® in the
United States. In addition to filing its ANDA, Mylan filed a
“paragraph IV certification” with the FDA alleging that the two
patents issued to Shire for the 4 mg dosage form of INTUNIV® are
invalid and would not be infringed by Mylan’s manufacture, use or

1

In addition to considering the parties’ briefs and oral arguments, the
Court has also had the benefit of reviewing several decisions by other
district courts that have construed many of the same terms and phrases
in the patents-in-suit. Specifically, the District of Delaware issued a
construction opinion in Shire LLC v. Teva Pharm. USA Inc. et al, No. 10329, 2012 WL 975694 (D. Del. Mar. 22, 2012), on March 22, 2012. Shortly
thereafter, on June 1, 2012, the Northern District of California issued
a construction decision in Shire LLC v. Impax Labs Inc. et al., No. 105467, 2012 WL 1980803 (N.D. Cal. June 1, 2012). Most recently, on
November 13, 2012, the District of Colorado issued a construction opinion
in Shire LLC v. Sandoz Inc., No. 1:11-01110, 2012 WL 5494944 (D. Colo.
Nov. 13, 2012).

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sale of the new drug described in its ANDA. In response, Shire
filed the first of two patent infringement actions pursuant to the
Hatch-Waxman Act, 35 U.S.C. § 271(e)(2)(A), Civil Action No.
1:11CV55, contending that the product described in Mylan’s ANDA
infringes claims in the two patents-in-suit.
More than six months later, in a letter dated October 31,
2011, Mylan notified Shire that it had amended its ANDA to include
1 mg, 2 mg, and 3 mg dosage forms of INTUNIV®. Mylan further
advised Shire that it had filed Paragraph IV certifications for the
‘599 and‘794 formulation patents directed to these new dosages. In
response, Shire filed the second patent infringement action, Civil
Action No. 1:11CV201, alleging that Mylan’s new 1 mg, 2 mg, and 3
mg ANDA products infringed the patents-in-suit.2 By Order entered
on February 21, 2012, the Court consolidated Shire’s two cases
against Mylan.
The parties have agreed that any claim term that appears in
the claims of both the ‘599 and the ‘794 patents should have the
same meaning in each patent. Prior to the Markman hearing, the
parties also submitted five agreed claim constructions, (dkt. no.

2

This suit originally included claims for infringement of U.S. Patent No.
5,854,290, which have since been dismissed by consent decree. (Dkt. No.
138).

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115), and reached an agreement on two terms that were originally
identified as disputed. Two terms and phrases from the asserted
claims remain in dispute: (1) the phrase “polymer that swells at a
pH in excess of 5.5,” which appears in Claim 2 of the ‘599 patent
and Claims 4 and 9 of the ‘794 patent; and (2) the term “about,”
which appears in Claims 18-23 of the ‘599 patent.
II.

LEGAL STANDARDS

The construction of patent claims presents a matter of law
governed by federal statutes and the decisions of the Supreme Court
of the United States and the United States Court of Appeals for the
Federal Circuit.

See Markman v. Westview Instruments, Inc., 52

F.3d 967, 979 (Fed. Cir. 1995).

When interpreting the meaning of

a claim, a court may consider the claims, specifications, and
prosecution histories as intrinsic evidence.

Id. (quoting Unique

Concepts, Inc. v. Brown, 939 F.2d 1558, 1561 (Fed. Cir. 1991)). The
invention itself, and the scope of a patentee’s right of exclusion,
will

be

defined

by

the

patent’s

claims.

Phillips

v.

AWH

Corporation, 415 F.3d 1303, 1312 (Fed. Cir. 2005) (en banc)
(quoting Innova/Pure Water, Inc. v. Safari Water Filtration Sys.,
Inc., 381 F.3d 1111, 1115 (Fed. Cir. 2004)); see also Vitronics
Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1582 (Fed. Cir. 1996)
(“[W]e look to the words of the claims themselves . . . to define
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the scope of the patented invention.”).

The description of an

invention in the claims, therefore, limits the scope of the
invention.

Id.

Claim terms should be construed according to their “ordinary
and customary” meaning, which is “the meaning that the term would
have to a person of ordinary skill in the art in question at the
time

of

the

invention.”

at

Id.

1313.

Claim

construction,

therefore, requires a court to determine how a person of ordinary
skill in the art would have understood the disputed term or phrase
in question. “Importantly, the person of ordinary skill in the art
is deemed to read the claim term not only in the context of the
particular claim in which the disputed term appears, but in the
context of the entire patent, including the specification.”

Id.

When construing patent claims, a court must consider the
context

of

the

entire

patent,

including

both

asserted

and

unasserted claims. Id. at 1314. Because a patent will ordinarily
use patent terms consistently, “the usage of a term in one claim
can often illuminate the meaning of the same term in other claims.”
Id. at 1314. Accordingly, “[d]ifferences among claims” can provide
insight into “understanding the meaning of particular claim terms,”
and “the presence of a dependent claim that adds a particular
limitation gives rise to a presumption that the limitation in
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question is not present in the independent claim.”

Id. at 1314-15

(citing Liebel-Flarsheim Co. v. Medrad, Inc., 358 F.3d 898, 910
(Fed. Cir. 2004)).
Aside from the claims themselves, the specification in the
patent

often

provides

technical term.’”

the

“‘best

source

for

understanding

a

Id. at 1315 (quoting Multiform Desiccants,Inc.

v. Medzam, Ltd., 133 F.3d 1473, 1478 (Fed. Cir. 1998)).

Pursuant

to 35 U.S.C. § 112, an inventor must use the specification to
describe his claimed invention in “full, clear, concise, and exact
terms.”

As such, “[t]he claims of a patent are always to be read

or interpreted in the light of its specifications.”

Schriber-

Schroth Co. v. Cleveland Trust Co., 311 U.S. 211, 217 (1940).
An inventor may alter the “ordinary and customary” meaning of
a term, however, by acting as his own lexicographer. This occurs,
for example, when the patent specification defines a term in a
manner

different

from

its

Phillips, 415 F.3d at 1316.

ordinary

and

customary

meaning.

Thus, it is “entirely appropriate for

a court, when conducting claim construction, to rely heavily on the
written description for guidance as to the meaning of the claims.”
Id. at 1317.
Nevertheless, a court may not import a limitation into the
claims from the specification. Id. at 1323. Moreover, the Federal
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Circuit has “repeatedly warned” against limiting the claims to the
embodiments specifically described in the specification.

Id.

In

other words, a court should not construe the patent claims as being
limited to a single embodiment simply because the patent describes
only one embodiment.

Id. (citing Gemstar-TV Guide Int’l Inc. v.

Int’l Trade Comm’n, 383 F.3d 1352, 1366 (Fed. Cir. 2004)).
The prosecution history of a patent may also provide insight
into the meaning of a term or phrase. “Like the specification, the
prosecution history provides evidence of how the PTO and the
inventor understood the patent.”

Id. at 1317.

The inventor’s

limitation of the invention during the patent’s prosecution may
suggest that a claim has a narrower scope than it otherwise might
have. Id.
Finally, when determining the ordinary and customary meaning
of a term, a court must be cautious when considering extrinsic
evidence, such as expert testimony, dictionaries, and learned
treatises.

Id.

Nevertheless, such sources may be reliable if

they were publicly available and show “‘what a person of skill in
the art would have understood disputed claim language to mean.’”
Id. at 1314 (quoting Innova, 381 F.3d at 1116).

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It is with these legal principles in mind that the Court now
turns to the construction of the two disputed terms or phrases
among the asserted claims of the patents-in-suit.
III.
A.

ANALYSIS

“polymer that swells at a pH in excess of 5.5”
The phrase “polymer that swells at a pH in excess of 5.5”

appears in dependent Claim 2 of the ‘599 patent and dependent
Claims 4 and 9 of the ‘794 patent. The parties dispute the
appropriate construction (or lack thereof) applicable to this term:
Mylan’s Proposed Construction

Shire’s Proposed Construction

A molecule with many units
joined to each other through
chemical covalent bonds, often
in a repeating manner, which
expands to a greater extent in
surrounding media having a pH
above 5.5 than in media having
a pH of 5.5 or below.

No construction (plain and
ordinary meaning) OR
a molecule with many units
joined to each other through
chemical bonds, often in a
repeating manner, which expands
at a pH above 5.5.

The

proposed

constructions

offer

substantially

similar

definitions of the word “polymer.” The gravamen of the parties’
dispute lies in Mylan’s use of comparative language to describe how
that polymer “swells.”
1.

Judicial Estoppel

Prior to analyzing these claims, the Court first considers
Mylan’s argument that Shire should be judicially estopped from
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opposing Mylan’s construction of the phrase “polymer that swells at
a pH in excess of 5.5.” According to Mylan, Shire earlier advocated
a comparative-swelling construction of this term, substantially
similar to Mylan’s proposal here, in its Markman briefing before
the District of Colorado in Shire LLC v. Sandoz Inc., No. 1:1101110, (Dkt. Nos. 89, 94) (D. Colo.).3 Characterizing Shire’s
current opposition to such a construction as “litigation-inspired”
and “inconsistent,” Mylan asks the Court to invoke the doctrine of
judicial estoppel to prevent Shire from “blowing hot and cold as
the occasion demands.” (Dkt. No. 130 at 4-5, 7).
The doctrine of judicial estoppel forbids a party from taking
a position inconsistent with one successfully asserted by that same
party in a prior proceeding.

Lowery v. Stovall, 92 F.3d 219, 223

(4th Cir. 1996). The doctrine “can apply to claim construction
arguments,” Fitness Quest Inc. v. Monti, 330 F. App’x 904, 914
(Fed. Cir. 2009) (citation omitted), and its applicability is “a
matter of regional circuit law.” Minn. Mining & Mfg. Co. v.
Chemque, Inc., 303 F.3d 1294, 1302-03 (Fed. Cir. 2002) (citation

3

Shire offered the following construction in the District of Colorado
action: “molecule with many units joined to each other through chemical
covalent bonds, often in a repeating manner, which expands in an
environment which has a pH above 5.5 relative to an environment that has
a pH of 5.5 or below.” (Dkt. No. 116-17 at 36).

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omitted). The Fourth Circuit has outlined three prerequisites for
judicial estoppel:
First, the party sought to be estopped must be seeking to
adopt a position that is inconsistent with a stance taken
in prior litigation. The position at issue must be one of
fact as opposed to one of law or legal theory. Second,
the prior inconsistent position must have been accepted
by the court. Lastly, the party against whom judicial
estoppel is to be applied must have intentionally misled
the court to gain unfair advantage. This bad faith
requirement is the determinative factor.
Zinkand v. Brown, 478 F.3d 634, 638 (4th Cir. 2007) (internal
citations and quotation marks omitted).
There is no question that the District of Colorado neither
construed nor addressed the phrase “polymer that swells at a pH in
excess of 5.5” in its Markman ruling. See Shire LLC v. Sandoz Inc.,
No. 1:11-01110, 2012 WL 5494944 (D. Colo. Nov. 13, 2012). Thus,
Shire’s prior position was not “accepted by the court” and does not
fulfill the second requirement of judicial estoppel. Zinkand, 478
F.3d at 638 (quoting Lowery, 92 F.3d at 224); see also New
Hampshire v. Maine, 532 U.S. 742, 750-51 (2001) (“Absent success in
a

prior

proceeding,

a

party’s

later

inconsistent

position

introduces no risk of inconsistent court determinations, and thus
poses little threat to judicial integrity.” (internal citations and
quotations marks omitted)). As the doctrine is inapplicable to this

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case,

Shire

is

not

precluded

from

opposing

Mylan’s

proposed

construction of the disputed term.
2.

The Claims

The Court begins its analysis by looking to the “actual words
of the claim,” Becton, Dickinson and Co. v. Tyco Healthcare Group,
LP, 616 F.3d 1249, 1254 (Fed. Cir. 2010), as well as the context in
which the disputed term appears. Phillips, 415 F.3d at 1314. Patent
claims come in two general forms: independent and dependent. 35
U.S.C. § 112(c). Independent claims do not refer to any other claim
of the patent and are read separately to determine their scope.
Intamin, Ltd. v. Magnetar Tech. Corp., 623 F.Supp.2d 1055, 1065
(C.D. Cal. 2009). Dependent claims, in contrast, refer to at least
one other claim, include all of the limitations of the claim to
which they refer, and specify a further limitation on that claim.
35 U.S.C. § 112(d); see also Monsanto Co. v. Syngenta Seeds, Inc.,
503 F.3d 1352, 1357 (Fed. Cir. 2007).
The disputed phrase “polymer that swells at a pH in excess of
5.5” appears in three dependent claims of the patents-in-suit. A
representative example of its use appears in Claim 2 of the ‘599
patent, which is, in turn, dependent on Element (c) of Claim 1:
Claim 1 (Independent):
A pharmaceutical composition, comprising:
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(a)
(b)
(c)

at least one pharmaceutically active agent that is
pH dependent;
at least one non pH dependent sustained release
agent;
at least one pH dependent agent that increases the
rate
of
release
of
said
at
least
one
pharmaceutically active agent from the tablet at a
pH in excess of 5.5
Claim 2 (Dependent):

The composition of claim 1 wherein said at least one pH
dependent agent is at least one polymer that swells at a
pH in excess of 5.5.
‘599 patent at Cls. 1-2 (emphasis added).
The parties have stipulated, and the Court agrees, that
Element (c) of Claim 1, the independent claim, should be construed
as:
[Ingredient] that is neither the non-pH dependent
sustained release agent [Element (b) of Claim 1] nor the
pharmaceutically active agent [Element (a) of Claim 1]
and that increases the rate of release of the
pharmaceutically active agent from a tablet more in an
environment that has a pH above 5.5 than in an
environment that has a pH of 5.5 or below.
(Dkt. No. 115 at 2 (first alteration in original)).4

4

Each district court that has construed this term has adopted a variation
of this stipulated construction. Shire LLC v. Sandoz Inc., No. 1:1101110, 2012 WL 5494944, at *4 (D. Colo. Nov. 13, 2012) (“agent that

increases the rate of release of the pharmaceutically active agent
from a tablet in an environment that has a pH above 5.5 relative to
an environment that has a pH of 5.5 or below”); Shire LLC v. Impax
Labs Inc. et al., No. 10-5467, 2012 WL 1980803, at *7 (N.D. Cal. June 1,
2012) (“Substance that is not the non-pH dependent sustained release
agent, and that increases the rate of release of the drug from the

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According

to

Mylan,

the

claims

support

its

proposed

construction because the “polymer that swells” must be a “pH
dependent agent.” ‘599 patent at Cl. 2. The “pH dependent agent,”
in

turn,

must

“increase[]

the

rate

of

release

of

the

pharmaceutically active agent from a tablet more in an environment
that has a pH above 5.5 than in an environment that has a pH of 5.5
or below.” (Dkt. No. 115 at 2). Mylan therefore deduces that, in
order to achieve this intended purpose, the polymer itself must
swell to a greater extent in an environment with a pH above 5.5
than in an environment with a pH of 5.5 or below. In essence, then,
Mylan urges the Court to find that polymer’s role as a “pH
dependent agent” imparts a separate, individualized pH-dependency
limitation into the phrase “polymer that swells.”
Shire, on the other hand, contends that, under the plain terms
of the patent, the only requirement for an ingredient to qualify as
a “pH dependent agent” is that it release the active pharmaceutical

composition in an environment having a pH above 5.5, as compared to when
the composition is an environment of pH 5.5 or below.”); Shire LLC v.
Teva Pharm. USA Inc. et al, No. 10-329, 2012 WL 975694, at *7 (D. Del.
Mar. 22, 2012) (“agent that is neither the non-pH dependent sustained
release agent nor the pharmaceutically active agent, and that increases
the rate of release of the pharmaceutically active agent from a tablet
more in an environment that has a pH above 5.5 than in an environment
that has a pH of 5.5 or below”). For the reasons more fully described in
those opinions, the Court ADOPTS the parties’ agreed construction of

this term.
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ingredient in a pH-dependent manner. In other words, as long as the
polymer

in

question

increases

the

rate

of

release

of

the

pharmaceutically active agent more in an environment that has a pH
above 5.5 than in an environment with a pH of 5.5 or below, as
required by Claim 1, and expands at a pH in excess of 5.5, as
required by Claim 2, it is irrelevant whether that polymer exhibits
pH-dependent

swelling.

Shire

contends

that

Mylan’s

proposed

construction imports an unwarranted limitation into the unambiguous
language of the claims.
The relevant claims are fairly straightforward. In keeping
with ordinary rules of construction for dependent claims, Claim 2
of the ‘599 patent “contain[s] a reference to a claim previously
set forth and then specif[ies] a further limitation of the subject
matter claimed.” 35 U.S.C § 112(d). In patent parlance, Claim 2
first uses the definite article “said” to refer to the antecedent
element of the “at least one pH dependent agent” described in
Element (c) of Claim 1. See generally Robert C. Faber, Landis on
Mechanics

of

Patent

Claim

Drafting

§

3:11

at

3–49

(2007)

(discussing “reference-back word[s]” such as “said,” which must be
followed by “the actual antecedent which the reference-back word
implies”); see also SanDisk Corp. v. Kingston Technology Co., Inc.,
695 F.3d 1348, 1360 (Fed. Cir. 2012). Claim 2 then specifically
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limits the “at least one pH dependent agent” of Claim 1 to “at
least one polymer that swells at a pH in excess of 5.5.” ‘599
patent at Cl. 2.
The Court must construe dependent claims “to incorporate by
reference all the limitations of the claim to which it refers.” 35
U.S.C. § 112(d). Here, as Claim 2 covers iterations of the claimed
composition in which the “pH dependent agent” of Claim 1 is a
“polymer that swells,” the relevant polymer must satisfy the
limitations of that antecedent claim. In other words, per the
parties’ agreed construction of Element (c) of Claim 1, the polymer
must be an “[ingredient] that . . . increases the rate of release
of the pharmaceutically active agent from a tablet more in an
environment that has a pH above 5.5 than in an environment that has
a

pH

of

5.5

or

below.”

(Dkt.

No.

115

at

2

(alteration

in

original)). As this construction shows, the independent claim does
not require the relevant “ingredient” to exhibit any specific,
individual characteristics. To the contrary, the only limitation is
that the “pH dependent agent,” whatever its individual properties,
“increase[] the rate of release of the pharmaceutically active
agent” in a pH-dependent way. Id.
As for the actual phrase “polymer that swells at a pH in
excess of 5.5,” Claim 2 - unlike Claim 1 and even dependent Claim
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45 - does not explicitly invite a comparison by describing an
“increase[]” in swelling at a pH greater than 5.5. Compare ‘599
patent at Cls. 1, 4, with id. at Cl. 2. To the contrary, it
provides only that the polymer “swell[] at a pH in excess of 5.5.”
Id. at Cl. 2. Notably, then, although the patentees used the
definite term “increases” to create a comparative limitation in
Claims 1 and 4, they omitted any similar words of comparison in
Claim 2. See Phillips, 415 F.3d at 1314 (“Differences among claims
can . . . be a useful guide in understanding the meaning of
particular claim terms.”). Indeed, the disputed phrase appears to
mean just what it says: namely, that the polymer must swell at a pH
greater than 5.5. The claims themselves do not further suggest that
the swelling be more than, less than, or the same as that which
occurs at a pH of 5.5 and below.
Mylan does not dispute the meaning a person of ordinary skill
in the art would ascribe to any of the individual words or phrases
of these claims. Rather, it paints its proposed construction as the
natural result of the polymer’s role as the independent claim’s “pH
dependent agent.” Relying on the opinion of its expert, Dr. Kinam

5

Claim 4 of the ‘599 patent provides: “The composition of claim 1 wherein
said at least one pH dependent agent is at least one agent that increases
the solubility of said at least one pharmaceutically active agent at a
pH of greater than 5.5.” ‘599 patent at Cl. 4 (emphasis added).

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Park, Ph.D. (“Dr. Park”),6 it contends that polymers, as a general
rule, release more active agents the larger they swell. (Dkt. No.
116-1 at 9). In light of this scientific principle, Mylan argues,
the claimed polymer, in order to release the pharmaceutically
active agent in the relative manner required by the independent
claim, would have to swell to a greater extent at a pH above 5.5
than it would at a pH of 5.5 and below. (Dkt. No. 116 at 19). Mylan
thus concludes that “[a] person of ordinary skill in the art
therefore would understand that the [disputed] phrase . . . refers
to a polymer that exhibits pH-dependent swelling.” (Dkt. No. 130 at
10-11).
The Court may rely on expert testimony as necessary to assist
it in understanding the underlying technology of a patent. Pitney
Bowes, Inc. v. Hewlett–Packard Company, 182 F.3d 1298, 1308 (Fed.
Cir. 1999) (citing Vitronics Corp., 90 F.3d at 1582); see also
Phillips, 415 F.3d at 1317-18. It is clear, however, that such
evidence

may

not

be

used

“for

the

purpose

of

varying

or

contradicting the terms of the claims.” Markman, 52 F.3d at 981.
Expert reports and other extrinsic evidence, in other words,

6

Mylan submitted Dr. Park’s declaration in conjunction with its briefing
and declined to call him live at the Markman hearing. The Court notes
that it was therefore unable to make credibility determinations or
evaluate Dr. Park’s report in light of cross-examination.

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“cannot add, subtract, or vary the limitations of the claims.” Id.
at 985; see also Bell Atl. Network Servs., Inc. v. Covad Comm’n
Group, Inc., 262 F.3d 1258, 1269 (Fed. Cir. 2001) (“[A]dditional
extrinsic evidence [such] as expert testimony . . . 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.”).
Mylan’s reliance on Dr. Park’s opinion is unpersuasive. As an
initial matter, Mylan presents its proposed construction as one of
basic scientific truths, i.e., that “polymers release [] active
agents via swelling,” and consequently, that the claimed polymer
“must” swell in a pH-dependent manner. (Dkt. No. 130 at 10). Dr.
Park, however, does not speak in such definite terms: without
specific citation to independent authority, he states only that
polymers, “generally speaking,” release more active ingredients the
greater they swell. (Dkt. No. 116-1 at 9). At this stage of the
case, this general statement of scientific principle alone does not
warrant a finding that those skilled in the art would generally
restrict the definition of “polymer[s] that swell[] at a pH in
excess of 5.5” within the context of these patents to those
polymers that swell in a pH-dependent manner.

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The task of the Court is to “define[] the claim with whatever
specificity and precision is warranted by the language of the claim
and the evidence bearing on the proper construction.” PPG Indus. v.
Guardian Indus. Corp., 156 F.3d 1351, 1355 (Fed. Cir. 1998). The
claim

language

independent

itself

nature

is

of

silent
the

as

to

relevant

the

pH-dependent

polymer’s

or

swelling;

consequently, Mylan’s restrictive construction finds no foothold in
the “actual words of the claim.” Becton, 616 F.3d at 1254. The
Court is thus reluctant to, as Mylan suggests, rely on extrinsic
evidence to adopt a construction that might define the disputed
term with greater specificity than is warranted by the claim
language.
3.

The Specifications

Having concluded that the plain language of the claims does
not explicitly include the limitation that the “polymer that
swells” do so to a greater extent in an environment with a pH above
5.5 than in an environment with a pH of 5.5 or below, the Court
turns to the specifications for guidance. Phillips, 415 F.3d at
1317. The specification of the ‘599 patent, which again serves as
a representative example, identifies “polymers that swell at a pH
in excess of 5.5” as one of three non-exclusive categories of

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“pH-dependent agents that increase the rate of release of the at
least one pharmaceutically active agent from the tablet at a pH in
excess of 5.5.” ‘599 patent at col. 2, ll. 8-11.7 Although the
specification

does

not

provide

an

express

definition

of

the

disputed term, it sets forth several examples: “Polymers that swell
at a pH in excess of 5.5 include, but are not limited to, acrylic
acid

copolymers,

sodium

alginate,

carrageenan,

alginic

acid,

pectin, and sodium carboxymethyl cellulose.” ‘599 patent at col 2,
ll. 19-22.
Mylan relies on extrinsic sources to argue that the examples
from

the

specification

provide

support

for

its

proposed

construction. Through Dr. Park, it contrasts the listed examples of
“polymers that swell at a pH in excess of 5.5” with the listed
examples of “non pH dependent sustained release agents.” ‘599

7

In full, this section states:
pH-dependent agents that increase the rate of release of the
at least one pharmaceutically active agent from the tablet at
a pH in excess of 5.5 include, but are not limited to,
polymers that swell at a pH in excess of 5.5, and enteric
agents, and/or agents that increase the solubility of the at
least one pharmaceutically active agent at a pH greater than
5.5, by maintaining an acidic microenvironment in the tablet,
e.g., an organic acid. The at least one pH-dependent agent is
present in the composition in an amount of from about 0.5 wt.
% to about 40 wt. %, preferably from about 1 wt. % to about 20
wt. %.

‘599 patent at col. 2, ll. 8-18.

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patent at col. 1, ll. 58-67, col. 2, ll. 19-22. Mylan contends that
the examples in the former category consist of polymers with
carboxyl functional groups, which swell more at higher pH values,
or sulfate functional groups, which can be “readily complexed” to
exhibit pH-dependent swelling. (Dkt. No. 116-1 at 9). Conversely,
the latter category of “non pH dependent sustained release agents,”
i.e., ingredients that slow the release of the pharmaceutically
active agent irrespective of pH,8 includes at least one polymer,
hydroxypropylmethylcellusose,

that

exhibits

pH-independent

swelling. Id. at 10. According to Mylan, the juxtaposition of these
two categories establishes that the inventors were “clearly aware”
that pH-independent polymers existed and deliberately elected to
identify them as “non pH dependent [] agents” but not “polymers
that swell at a pH in excess of 5.5.” (Dkt. No. 116 at 20-21).
The specification is often described as “‘the single best
guide to the meaning of a disputed term.’” Phillips, 415 F.3d at
1315 (quoting Vitronics, 90 F.3d at 1582). Nevertheless, “the scope
of

patent

protection”

is

defined

8

by

“[t]he

claims,

not

The parties have stipulated that the phrase “non-pH dependent sustained
release agent” means “[ingredient] that slows release of the
pharmaceutically active agent over an extended period of time regardless
of gastrointestinal pH, and that is not the pH dependent agent.” (Dkt.
No. 115 at 2 (alteration in original)). The Court ADOPTS this
construction.

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specification embodiments.” Kara Technology Inc. v. Stamps.com
Inc., 582 F.3d 1341, 1348 (Fed. Cir. 2009). The specification may
only

narrow

the

meaning

of

a

claim

term

in

certain

limited

circumstances, SciMed Life Sys., Inc. v. Advanced Cardiovascular
Sys., Inc., 242 F.3d 1337, 1340-41 (Fed Cir. 2001), and a claim
generally will not be confined to its embodiments “unless the
patentee has demonstrated a ‘clear intention’ to limit the claim’s
scope

with

‘words

or

expressions

of

manifest

exclusion

or

restriction.’” I4I Ltd. P’ship v. Microsoft Corp, 598 F.3d 831, 843
(Fed. Cir. 2010) (quoting Liebel-Flarsheim Co. v. Medrad, Inc., 358
F.3d 898, 907-08 (Fed. Cir. 2004)).
Here,

the

specification

contains

no

language

that

would

unequivocally narrow the claims to require the “polymer that
swells” to exhibit pH-dependent swelling. To the contrary, the
specification clearly states that the representative examples of
“polymers that swell” do not constitute an exhaustive list. ‘599
patent at col 1, ll. 19-20 (“Polymers that swell at a pH in excess
of 5.5 include, but are not limited to . . . .” (emphasis added)).
To the extent that Mylan presents the examples as a limit on the
disputed claim, then, it runs afoul of settled law. Phillips, 415
F.3d at 1323 (“[W]e have repeatedly warned against confining the
claims to those [specific] embodiments.”); see, e.g., Cohesive
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Techs., Inc. v. Waters Corp., 543 F.3d 1351, 1360 (Fed. Cir. 2008)
(declining to limit “rigid” to monomeric particles even though
embodiments used only monomeric particles).
Mylan’s attempt to find contextual support for its position
within the specification examples is likewise unavailing. Three
polymers that appear as examples of “polymers that swell at a pH in
excess

of

5.5”

-

carrageenan,

alginic

acid,

and

sodium

carboxymethyl cellulose - are also listed as examples of “non pH
dependent sustained release agents.” Compare ‘599 patent at col. 1,
ll. 58-67 with ‘599 patent col. 2, ll. 19-22. These three polymers
can thus serve as either “pH dependent agents” or “non pH dependent
[] agents” within different iterations of the claimed composition.
Inasmuch as these two categories are neither mutually exclusive nor
limited to their identified examples, they fail to support Mylan’s
theory that the patentees deliberately drew a firm line between phdependent and ph-independent agents. To the contrary, the overlap
of these agents serves to highlight the flexibility of the various
ingredients

that

can

serve

as

components

for

the

claimed

composition.
In short, any contrast between the polymers identified as
potential “pH dependent agents” or “non pH dependent [] agents” is
not as clear-cut or determinative as Mylan would suggest. Even if
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it were, however, the Court would not limit the plain language of
the claim on the basis of the specification’s non-exhaustive
sampling of suitable agents.
4.

Court’s Construction

In sum, the Court will not construe claims that do not
specifically recite a pH-dependent swelling limitation to include
such a limitation, as such a construction is neither recited in the
claim language nor supported by the specification. The Court
instead

adopts

the

Northern

District

of

California’s

well-

considered construction of this term, which Shire has offered as an
alternative, see Shire LLC, 2012 WL 1980803, at *7, and construes
the phrase “polymer that swells at a pH in excess of 5.5” as “a
molecule with many units joined to each other through chemical
bonds, often in a repeating manner, which expands at a pH above
5.5.”
B.

“About”

The term “about” appears in Claims 18-23 of the ‘599 patent.
Specifically,

each

of

these

claims

states

that

a

particular

component “is present in the composition in an amount of from about
__ wt.% to about __ wt. %,” with numerical values ranging between
0.095 to 70. Shire argues that “about” should either be left

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unconstrued or interpreted to mean “approximately.” Mylan, on the
other hand, contends that “about” should be ascribed a precise
numerical range, i.e., a plus or minus 5% variation on each
corresponding weight percent.9
According to the Federal Circuit, the use of a qualifying word
such

as

“about”

avoids

a

“strict

numerical

boundary

to

the

specified parameter” and the appropriate range “must be interpreted
in its technological and stylistic context.” Ortho–McNeil Pharm.,
Inc. v. Caraco Pharm. Labs., Ltd., 476 F.3d 1321, 1326 (Fed. Cir.
2007) (quoting Pall Corp. v. Micron Separations, Inc., 66 F.3d
1211, 1217 (Fed. Cir. 1995)). In order to determine how far beyond
a specified range the term “about” extends the claim, courts “must
focus . . . on the criticality,” or underlying purpose, “of the
[numerical limitation] to the invention.” Cohesive Techs., Inc. v.
Waters Corp., 543 F.3d 1351, 1368 (Fed. Cir. 2008) (alteration in
original) (quoting Ortho-McNeil, 476 F.3d at 1327). Courts should
also

consider

the

use

of

the

9

term

within

the

patent,

the

Under Mylan’s proposal, “about 0.1 wt.% to about 70 wt.%” (claim 18)
means “0.095 wt.% to 73.5 wt.%; “about 1 wt.% to about 40 wt.%” (claim
19) means “0.95 wt.% to 42 wt.%;” “about 5 wt.% to about 50 wt.%” (claim
20) means “4.75 wt.% to 52.5 wt.%;” about 10 wt.% to about 30 wt.%.
(claim 21) means “9.5 wt.% to 31.5.wt %;” “about 0.5 wt.% to about 40
wt.%” (claim 22) means “0.475 wt.% to 42 wt.%;” “about 1 wt.% to about
20 wt.%” (claim 23) means “0.95 wt.% to 21 wt.%.”

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prosecution history, and the possible effects of varying its
parameters. Ortho–McNeil, 476 F.3d at 1326. Further, “[e]xtrinsic
evidence of meaning and usage in the art may be helpful in
determining the criticality of the parameter.” Id. (quoting Pall
Corp., 66 F.3d at 1217).
Here, there is nothing in the claims, specifications, or
prosecution history of the ‘599 patent that would illuminate the
range “about” imparts to the various weight percents. Consequently,
to support its proposed construction, Mylan relies heavily on the
affidavit

of

Dr.

Park,

who

opines

that,

“in

the

field

of

formulation science, acceptable variations on weight percents
typically consist of variations in the range of 5-10% of the
specified weight.” (Dkt. No. 116-1 at 10-11). He theorizes that the
lowest end of this allowance, a 5% variation, is appropriate in
this case because “the patent describes and claims weight percent
limits with precision in the tenths of percents,” figures which
“suggest[] an intent [by the patentees] to provide significant
specificity in setting forth the bounds of the claimed ranges.” Id.
at 11.
Although courts may rely upon extrinsic evidence when the
intrinsic evidence is not sufficient to construe the claim, Bell &
Howell Document Mgmt. Prods. Co. v. Altek Sys., 132 F.3d 701, 706
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(Fed. Cir. 1997), such evidence ranks low on the evidentiary
hierarchy. Phillips, 415 F.3d at 1319. Dr. Park’s interpretation of
“about,” in particular, carries little weight. His affidavit on
this issue merely recites Mylan’s theory without reference to any
industry publications or other independent sources. See Network
Commerce, Inc. v. Microsoft Corp., 422 F.3d 1353, 1361 (Fed. Cir.
2005) (discounting expert testimony for lack of reference to
industry publications or independent sources). To the extent that
he attempts to ground his opinion in the fact that the patent
includes weight percents “in tenths” (dkt. no. 116-1 at 11), the
Court

fails

to

see

the

logical

connection

between

the

mere

existence of these fractional numbers and the selection of a 5% as opposed to a 6, 7, 8, 9, or 10% - variation range. Mylan’s
proposal,

quite

simply,

appears

unmoored

from

any

reliable

intrinsic or extrinsic evidentiary foundation.
Recently, the District Court of Colorado construed these same
claims and adopted the construction “approximately” for the term
“about.” Shire LLC., 2012 WL 5494944, at *6. Without any evidence
that would provide a basis to specify the permissible deviation
from the weight percents in the ‘599 patent, this Court also
concludes that the term “about” should be given its ordinary and
accepted meaning of “approximately.” See Merck & Co. v. Teva
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Pharms. USA, Inc., 395 F.3d 1364, 1372 (Fed. Cir. 2005); see
generally Acumed LLC v. Stryker Corp., 483 F.3d 800, 806 (Fed. Cir.
2007) (“[A] sound claim construction need not always purge every
shred of ambiguity.”).
Thus, the Court construes the term “about” in Claims 18-23 of
the ‘599 patent as “approximately.”
IV.

CONCLUSION

For the reasons discussed, the Court CONSTRUES the contested
claim terms and phrases as follows:
1.

“Polymer that swells at a pH in excess of 5.5” means “A
molecule with many units joined to each other through
chemical

bonds,

often

in

a

repeating

manner,

which

agreed

claim

expands at a pH above 5.5”; and
2.

“About” means “Approximately.”

Further,

the

Court

adopts

the

parties’

constructions and CONSTRUES the following terms and phrases as
follows:
1.

“Non-pH dependent sustained release agent” shall be
construed as “[ingredient] that slows release of the
pharmaceutically active agent over an extended period of

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time regardless of gastrointestinal pH, and that is not
the pH dependent agent”;
2.

“pH dependent agent that increases the rate of release of
said pharmaceutically active agent from the tablet at a
pH in excess of 5.5” shall be construed as “[ingredient]
that is neither the non-pH dependent sustained release
agent nor the pharmaceutically active agent, and that
increases the rate of release of the pharmaceutically
active agent from a tablet more in an environment that
has a pH above 5.5 than in an environment that has a pH
of 5.5 or below”;

3.

“Agent that increases the solubility of said at least one
pharmaceutically active agent at a pH of greater than
5.5” shall be construed as “[ingredient] that increases
the amount of the pharmaceutically active agent that will
dissolve in a given amount of another substance to a
greater extent in an environment which has a pH above 5.5
than in an environment which has a pH of 5.5. or below”;

4.

“reducing the likelihood of side effects associated with
the administration of guanfacine” shall be given its
plain and ordinary meaning; and

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5.

“binding agent” shall be given its plain and ordinary
meaning.

It is so ORDERED.
The Court directs the Clerk to transmit copies of this Order
to counsel of record.
DATED: January 14, 2013

/s/ Irene M. Keeley
IRENE M. KEELEY
UNITED STATES DISTRICT JUDGE

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