Allergan, Inc. v. Sandoz Inc
Filing
118
MEMORANDUM OPINION AND ORDER construing the disputed claim terms of U.S. Patent No. 7,851,504 entitled Enhanced Bimatoprost Opthalmic Solution. Signed by Judge Michael H. Schneider on 1/10/13. (mjc, )
United States District Court
EASTERN DISTRICT OF TEXAS
TYLER DIVISION
ALLERGAN, INC.
v.
SANDOZ INC., ET AL.
§
§
§
§
§
Case No. 6:11-cv-441
MEMORANDUM OPINION AND ORDER
This claim construction order construes the disputed claim terms of U.S. Patent No.
7,851,504 (‘504 patent) entitled “Enhanced Bimatoprost Opthalmic Solution.”1 On September
27, 2012, the Court held a claim construction hearing to construe the disputed terms. For the
following reasons, the Court adopts the constructions set forth below.
I.
BACKGROUND
This is a patent infringement action filed pursuant to the Hatch-Waxman Act. Congress
passed the Hatch-Waxman Act in 1984 to promote the manufacturing of generic
pharmaceuticals. See Drug Price Competition and Patent Term Restoration Act, 98 Stat. 1585
(1984); PLIVA, Inc. v. Mensing, 131 S. Ct. 2567, 2574 (2011). “Under this law, ‘generic drugs’
can gain [Federal Drug Administration (FDA)] approval simply by showing equivalence to a
reference listed drug that has already been approved by the FDA.” Mensing, 131 S. Ct. at 2574.
“This allows manufacturers to develop generic drugs inexpensively, without duplicating the
clinical trials already performed on the equivalent brand-name drug.” Id.
1
In this infringement action, Plaintiff also asserts U.S. Patent No. 5,688,819 (‘819 patent) entitled “Cyclopentane
Heptanoic Acid, 2-Cycloalkyl or Arylalkyl Derivatives as Therapeutic Agents.” The ‘819 patent was previously
litigated between Plaintiff and Defendant Sandoz Inc. in the United States District Court for the District of
Delaware. See Allergan, Inc. v. Barr Labs., Inc., No. 1:09-cv-333 (D. Del. filed May 7, 2009). That case has since
been appealed. See Allergan, Inc. v. Barr Labs., Inc., No. 12-1040 (Fed. Cir. filed Oct. 21, 2011). Although the
parties in this case dispute the construction of a claim term in the ‘819 patent, they agree to be bound by the
appellate court’s decision on the disputed term. Accordingly, the Court finds it unnecessary to consider any claim
construction issues related to the ‘819 patent at this time.
Page 1 of 16
Plaintiff Allergan, Inc. obtained FDA approval for Lumigan® 0.03% bimatoprost
ophthalmic solution in 2001. In late 2010, Plaintiff obtained FDA approval for Lumigan® 0.01%
bimatoprost ophthalmic solution for the reduction of elevated intraocular pressure in certain
patients, including those with open angle glaucoma or ocular hypertension. The active ingredient
in Lumigan® is the prostaglandin analog bimatoprost, which operates by increasing the outflow
of aqueous humor from the eye.
Defendants have each filed an Abbreviated New Drug Application (ANDA) for FDA
approval to market a generic version of Plaintiff’s Lumigan® 0.01% bimatoprost ophthalmic
solution. Defendants seek to market their generic versions prior to the expiration of the patents
listed in the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations
publication (known as the Orange Book) as covering Plaintiff’s Lumigan® 0.01% bimatoprost
ophthalmic solution.
Defendants filed their ANDAs pursuant to a procedure called paragraph IV certification.
See 21 U.S.C. § 355(j)(2)(A). Under this procedure, Defendants certified that the patents listed in
the Orange Book are invalid or will not be infringed by their generic pharmaceuticals. “Such a
certification constitutes an artificial act of infringement.” Pozen Inc. v. PAR Pharm., Inc., 696
F.3d 1151, 1157 (Fed. Cir. 2012). Accordingly, Plaintiff filed complaints against Defendants for
infringement of the ‘504 patent and the ‘819 patent.
A total of four patents are listed in the FDA’s Orange Book as covering Lumigan®
0.01% bimatoprost ophthalmic solution. Of those, Plaintiff asserts the ‘504 patent against all
Defendants and the ‘819 patent only against Defendant Sandoz Inc. The ‘504 patent is directed to
the drug’s formulation while the ‘819 patent generally relates to the use of bimatoprost to treat
glaucoma.
Page 2 of 16
The ‘504 patent contains three independent claims directed to compositions. Independent
claim 3 of the ‘504 patent is representative:
A composition having a pH of about 7.3 which comprises about
0.01% bimatoprost, 200 ppm benzalkonium chloride, about 0.014
citric acid monohydrate, a phosphate buffer, NaCl, and water
wherein said composition is an aqueous liquid which is formulated
for ophthalmic administration.
‘504 Patent at 6:26–30.
II.
LEGAL STANDARD
Claim construction is a matter of law. Markman v. Westview Instruments, Inc., 52 F.3d
967, 979 (Fed. Cir. 1995). The purpose of claim construction is to resolve the meanings and
technical scope of claim terms. U.S. Surgical Corp. v. Ethicon, Inc., 103 F.3d 1554, 1568 (Fed.
Cir. 1997). When the parties dispute the scope of a claim term, “it is the court’s duty to resolve
it.” O2 Micro Int’l Ltd. v. Beyond Innovation Tech. Co., 521 F.3d 1351, 1362 (Fed. Cir. 2008).
The claims of a patent define the scope of the invention. Teleflex, Inc. v. Ficosa N. Am.
Corp., 299 F.3d 1313, 1324 (Fed. Cir. 2002). They provide the “metes and bounds” of the
patentee’s right to exclude. Corning Glass Works v. Sumitomo Elec. U.S.A., Inc., 868 F.2d 1251,
1257 (Fed. Cir. 1989). Accordingly, claim construction begins with and “remain[s] centered on
the claim language itself.” Innova/Pure Water, Inc. v. Safari Water Filtration Sys., Inc., 381 F.3d
1111, 1116 (Fed. Cir. 2004).
Claim terms are normally given their “ordinary and customary meaning.” Phillips v.
AWH Corp., 415 F.3d 1303, 1312 (Fed. Cir. 2005) (quoting Vitronics Corp. v. Conceptronic,
Inc., 90 F.3d 1576, 1582 (Fed. Cir. 1996)). Generally, “the ordinary and customary meaning of a
claim term 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.” Id at 1313.
Page 3 of 16
The best guide for defining a disputed term is a patent’s intrinsic evidence. Teleflex, 299
F.3d at 1325. Intrinsic evidence includes the patent’s specification and the prosecution history.
Id.
The claims are part of the specification. Markman, 52 F.3d at 979. .”). “[T]he context in
which a term is used in the asserted claim can be highly instructive.” Phillips, 415 F.3d at 1314;
see also Abtox, Inc. v. Exitron Corp., 122 F.3d 1019, 1023 (Fed Cir. 1997) (“[T]he language of
the claim frames and ultimately resolves all issues of claim interpretation “Differences among
claims can also be a useful guide in understanding the meaning of particular claim terms.”
Phillips, 415 F.3d at 1314.
In addition to the claims, the specification’s written description is an important
consideration during the claim construction process. See Vitronics Corp., 90 F.3d at 1582. The
written description provides further context for claim terms and may reflect a patentee’s intent to
limit the scope of the claims. See Watts v. XL Sys., Inc., 232 F.3d 877, 882 (Fed. Cir. 2000).
“[T]he specification ‘is always highly relevant to the claim construction analysis. Usually, it is
dispositive; it is the single best guide to the meaning of a disputed term.’” Phillips, 415 F.3d at
1315 (quoting Vitronics, 90 F.3d at 1582).
The specification may also resolve ambiguous claim terms “where the ordinary and
accustomed meaning of the words used in the claims lack sufficient clarity to permit the scope of
the claim to be ascertained from the words alone.” Teleflex, Inc., 299 F.3d at 1325. For example,
“[a] claim interpretation that excludes a preferred embodiment from the scope of the claim ‘is
rarely, if ever, correct.’” Globetrotter Software, Inc. v. Elam Computer Grp., Inc., 362 F.3d
1367, 1381 (Fed. Cir. 2004) (quoting Vitronics Corp., 90 F.3d at 1583).
Page 4 of 16
But care must be taken to avoid unnecessarily reading limitations from the specification
into the claims. Teleflex, 299 F.3d at 1326; see also Raytheon Co. v. Roper Corp., 724 F.2d 951,
957 (Fed. Cir. 1983) (“That claims are interpreted in light of the specification does not mean that
everything expressed in the specification must be read into all the claims.”). “[P]articular
embodiments appearing in the written description will not be used to limit claim language that
has broader effect.” Innova/Pure Water, 381 F.3d at 1117; see also Phillips, 415 F.3d at 1323
(“[A]lthough the specification often describes very specific embodiments of the invention, we
have repeatedly warned against confining the claims to those embodiments.”).
The prosecution history is also part of the intrinsic evidence. Phillips, 415 F.3d at 1317. It
“consists of the complete record of the proceedings before the PTO and includes the prior art
cited during the examination of the patent.” Id. “As in the case of the specification, a patent
applicant may define a term in prosecuting a patent.” Home Diagnostics, Inc. v. LifeScan, Inc.,
381 F.3d 1352, 1356 (Fed. Cir. 2004). Statements made during the prosecution of the patent may
limit the scope of the claims. Teleflex, 299 F.3d at 1326; see Omega Eng’g Inc. v. Raytek Corp.,
334 F.3d 1314, 1323 (Fed. Cir. 2003) (explaining that the doctrine of prosecution disclaimer
“preclud[es] patentees from recapturing through claim interpretation specific meanings
disclaimed during prosecution”).
Finally, the Court may rely on extrinsic evidence to aid with understanding the meaning
of claim terms. Markman, 52 F.3d at 981. Extrinsic evidence includes “all evidence external to
the patent and prosecution history, including expert and inventor testimony, dictionaries, and
learned treatises.” Id. at 980. Extrinsic evidence is generally less useful or reliable, Phillips, 415
F.3d at 1317, and it should not be relied on when it contradicts the intrinsic evidence, Markman,
52 F.3d at 981.
Page 5 of 16
III.
DISCUSSION
The parties’ dispute focuses on the meaning and scope of two phrases in the claims of the
‘504 patent. The parties make identical arguments with respect to both terms. Additionally, the
parties agree on the construction of a number of other terms.
a. “[A] composition . . . which comprises . . . citric acid monohydrate . . . wherein
said composition is an aqueous liquid”2
Disputed Claim Term
“[A] composition . . . which
comprises . . . citric acid
monohydrate . . . wherein said
composition is an aqueous
liquid”
Plaintiff’s Proposed
Construction
The term does not require
construction, but if the Court
chooses to construe the term,
it should construe it as “a
composition that is an aqueous
liquid in which citric acid
monohydrate is one of the
materials that is used to
prepare the composition.”
Defendants’ Proposed
Construction
“a composition that is an
aqueous liquid comprising . . .
citric acid in crystalline form
containing only one water
molecule per molecule of
citric acid, where the water
molecules are incorporated
into the crystals”
The dispute between the parties concentrates on the characterization of “citric acid
monohydrate” in the composition. As an initial matter, the parties are in agreement that citric
acid monohydrate is a crystalline substance with a lattice chemical structure containing one
water molecule per citric acid molecule. Furthermore, the parties agree that when added to water,
citric acid monohydrate dissociates to citric acid and water.
Turning to construction issues, Plaintiff states that the term does not require any
construction. To the extent the Court finds construction necessary, Plaintiff argues that the
claims only require citric acid monohydrate be an ingredient in the composition. Plaintiff
contends that the claims do not command that citric acid monohydrate remain in crystalline form
in the formulation. Rather, Plaintiff concludes that the citric acid monohydrate dissolves into
solution because the claims require the formulation to be an aqueous liquid.
2
The phrase “a composition . . . which comprises . . . citric acid monohydrate . . . wherein said composition is an
aqueous liquid” is found in the ‘504 patent at claims 2 and 3.
Page 6 of 16
Defendants argue that Plaintiff misinterprets the claims. Defendants allege that the claims
cover a final composition rather than a recipe with a list of ingredients. Defendants believe it is
appropriate to define citric acid monohydrate as remaining in crystalline form in the formulation.
Defendants argue that Plaintiff’s construction improperly redrafts the claims. Instead of “citric
acid monohydrate” remaining a component of the formulation, Defendants argue Plaintiff is
attempting to rewrite the claims as product-by-process claims.
The Court finds that Plaintiff’s proposed construction is consistent with the claim
language. This construction finds support in the claim language, the specification, the
prosecution history, and the extrinsic evidence.
i. The Claim Language
Defendants argue that the claim language compels the adoption of Defendants’ proposed
construction. Defendants allege that the use of the term “composition” in the claims has a wellestablished meaning in patent law. Defendants rely on Exxon Chemical Patents, Inc. v. Lubrizol
Corp., 64 F.3d 1553, 1558 (Fed. Cir. 1995), and PIN/NIP, Inc. v. Platte Chemical Co., 304 F.3d
1235, 1244 (Fed. Cir. 2002), to establish the broad principle that a “chemical composition exists
at the moment the ingredients are mixed together. Before creation of the mixture, the ingredients
exist independently.” Exxon Chem. Patents, Inc., 64 F.3d at 1558; see also PIN/NIP, 304 F.3d at
1244. Defendants argue that the use of “composition” requires “specified ingredients at any time
from the moment at which the ingredients are mixed together.” PIN/NIP, 304 F.3d at 1244.
Although Defendants reference sound principles of claim construction, the Court does not
find that they compel adoption of Defendants’ proposed construction. Defendants’ reliance on
the proposition that a composition is “a mixture in which the components are present together at
Page 7 of 16
some point in time” does not translate to requiring citric acid monohydrate to remain in
crystalline form in the formulation.
Defendants’ position fails to consider the term “composition” in the context of the
entirety of the claim. See Abbott Labs. v. Syntron Bioresearch, Inc., 334 F.3d 1343, 1351 (Fed.
Cir. 2003) (“The usage of the disputed claim terms in the context of the claims as a whole also
informs the proper construction of the terms.”); Phillips, 415 F.3d at 1314 (“[T]he claims
themselves provide substantial guidance as to the meaning of particular claim terms.”). In
context, the claim language requires that “said composition is an aqueous liquid which is
formulated for ophthalmic administration.” ‘504 Patent at 6:29–30. The description that the
composition is an aqueous liquid is in direct contradiction to Defendants’ proposal. A person of
ordinary skill in the art at the time of the invention would understand that the ordinary and
customary meaning of the claim term would be that citric acid monohydrate is a component
which dissolves into the aqueous based solution. See Phillips, 415 F.3d at 1313 (“The inquiry
into how a person of ordinary skill in the art understands a claim term provides an objective
baseline from which to begin claim interpretation. That starting point is based on the well-settled
understanding that inventors are typically persons skilled in the field of the invention and that
patents are addressed to and intended to be read by others of skill in the pertinent art.” (citations
omitted)).
Although citric acid monohydrate in crystalline form is an ingredient in the mixture, a
person of ordinary skill in the art would appreciate that it would be scientifically impossible for it
to remain in crystalline form in an aqueous based environment. Additionally, the existence of
citric acid monohydrate in crystalline form in a product for “ophthalmic administration” would
be inconsistent with the understanding of a person of ordinary skill in the art that a substance
Page 8 of 16
containing crystals could not be administered to the eye. Therefore, requiring a construction
specifying the existence of crystalline citric acid monohydrate in an aqueous solution would be
inconsistent with the entirety of the claim language.
Defendants further argue that Plaintiff’s interpretation of the claims is rewriting product
claims to product-by-process claims. Defendants reason that the asserted claims are directed to
compositions, and not recipes for making the end product. Relying on Exxon, Defendants
conclude that Plaintiff is improperly rewriting its claims because Plaintiff’s construction
incorporates the requirement that the composition be an aqueous solution with the components
properly dissolved. See Exxon, 64 F.3d at 1563 (Plager, J., concurring).
The Court disagrees that Plaintiff is attempting to rewrite its claims. Rather, the Court
finds controlling the reasoning in Norian Corp. v. Stryker Corp., 432 F.3d 1356, 1362 (Fed. Cir.
2005). In Norian, the court accepted that a solution could be defined by “the ingredients used to
make the solution.” Norian, 432 F.3d at 1362. The court found that the characterization of a
“solution in terms of the components put into it” was a “conventional means of describing a
solution.” Id. The court concluded that the claims were not product-by-process claims but
remained product claims “limited to the designated ingredients from which the claimed solution
was made.” Id. Here, the Court is confronted with the identical situation presented in Norian. In
drafting its claims, Plaintiff was allowed to describe the resulting aqueous solution in terms of its
ingredient parts. Therefore, the Court finds that Plaintiff’s construction does not impermissibly
attempt to rewrite the claims as product-by-process claims.
The claim language as a whole guides the proper construction in this case. Accordingly,
the Court finds that Plaintiff’s proposed construction is consistent with the ordinary and
customary meaning of the claim term as understood by one of ordinary skill in the art at the time
Page 9 of 16
of the invention. See Invitrogen Corp. v. Biocrest Mfg., L.P., 327 F.3d 1364, 1367 (Fed. Cir.
2003) (“Claim language generally carries the ordinary meaning of the words in their normal
usage in the field of invention.”).
ii. The Intrinsic Evidence
In addition to the claims, the other intrinsic evidence in this case, specifically the
specification and prosecution history, supports the adoption of Plaintiff’s construction.
Similar to the arguments put forth by the Defendants with respect to the claims,
Defendants argue that the specification consistently refers to the invention as a composition
rather than a recipe. Therefore, Defendants urge this Court to hold that this language in the
specification prevents Plaintiff from introducing process elements into its proposed construction.
Defendants’ analysis is misguided. As previously discussed, the Court does not find that
Plaintiff’s construction alters the scope of the claims to product-by-process claims. The parties
are actually in agreement that the claims are directed to products.
Defendants also highlight that the specification contains references to both “citric acid
monohydrate” and “citric acid.” Compare ‘504 Patent at 2:66 with ‘504 Patent at 3:55. Thus,
Defendants argue that Plaintiff understood how to use the terms and differentiate between them.
The Court finds that this argument actually undercuts Defendants’ position. The fact that
Plaintiff used “citric acid monohydrate” and “citric acid” interchangeably in the specification
would indicate to one skilled in the art that the ultimate ingredient in the formulation is aqueous
citric acid. A person of ordinary skill would recognize that the addition of citric acid
monohydrate to the composition would result in aqueous citric acid. Therefore, the use of “citric
acid monohydrate” to achieve the claimed formulation is permissible. See generally Phillips, 415
F.3d at 1314 (unless otherwise indicated, “claim terms are normally used consistently throughout
Page 10 of 16
the patent”). In contrast, the specification contains no support for Defendants’ position that citric
acid monohydrate is intended to remain crystalline in the composition.
In support of its own construction, Plaintiff notes that Defendants’ proposal would read
out every embodiment in the best mode section of the specification because each embodiment
uses “Citric Acid, Monohydrate.” See ‘504 Patent at 2:59–3:50. Plaintiff argues that Defendants’
construction requiring citric acid monohydrate to remain in crystalline form once in solution is in
contradiction to the preferred embodiments, which make no similar restriction. The Court agrees
that adoption of Defendants’ construction would read out all of the embodiments, including the
preferred embodiment, directed at claims 2 and 3. Interpreting a claim such that it would read out
the preferred embodiment “is rarely, if ever, correct and would require highly persuasive
evidentiary support.” Vitronics, 90 F.3d at 1583. Defendants have not provided highly persuasive
evidentiary support to justify its interpretation of the claim language.
Furthermore, a person skilled in the art would understand that Plaintiff’s reference to both
“citric acid monohydrate” and “citric acid” was not done to differentiate between the two in the
composition. Plaintiff’s use of “citric acid monohydrate” and “citric acid” supports the
understanding that citric acid is present in the composition by means of citric acid monohydrate.
See Oatey Co. v. IPS Corp., 514 F.3d 1271, 1276 (Fed. Cir. 2008) (explaining that, absent clear,
unambiguous disclaimer, the court generally does “not interpret claim terms in a way that
excludes embodiments disclosed in the specification”). Even in light of Plaintiff’s use of both
terms, a person of ordinary skill would apprehend that citric acid monohydrate would not be
required to remain crystallized once in the formulation. See Phillips, 415 F.3d at 1313
(“Importantly, the person of ordinary skill in the art is deemed to read the claim term not only in
Page 11 of 16
the context of the particular claim in which the disputed term appears, but in the context of the
entire patent, including the specification.”).
The prosecution history additionally supports Plaintiff’s interpretation of the claim
language. The phrase “citric acid monohydrate” was added in an amendment to what became
claims 2 and 3 of the ‘504 patent. See Doc. No. 70-22 at 3. In support of the amendment,
Plaintiff pointed to “Examples 1 and 3” in the written description. Id. at 6–7. Both examples only
use the phrase “citric acid,” and not crystalline “citric acid monohydrate.” This further
demonstrates that the claims were drafted with the understanding that citric acid monohydrate is
an ingredient in the composition that dissolves in solution to form citric acid.
Importantly, the prosecution history is devoid of any disclaimer of claim scope. The
Defendants have not identified any section of the prosecution history where the patentee clearly
and unambiguously disclaimed the embodiment where citric acid monohydrate is added to a
solution such that it becomes citric acid. See Middleton, Inc. v. Minn. Mining & Mfg. Co., 311
F.3d 1384, 1388 (Fed. Cir. 2002) (requiring disclaimer to be “clear and unambiguous” in the
prosecution history).
In this case, the specification and the prosecution history support the adoption of
Plaintiff’s proposed construction. The intrinsic record reinforces a reading that citric acid
monohydrate need not remain in crystalline form in the composition.
iii. The Extrinsic Evidence
Generally, extrinsic evidence is considered “less reliable than the patent and its
prosecution history in determining how to read claim terms.” Phillips, 415 F.3d at 1318.
“[E]xtrinsic evidence may be useful to the court, but it is unlikely to result in a reliable
interpretation of patent claim scope unless considered in the context of the intrinsic evidence.”
Page 12 of 16
Id. at 1319. In this case, the Court finds that in light of the intrinsic evidence, the extrinsic
evidence supports Plaintiff’s construction.
In their ANDAs, Defendants describe their generic pharmaceuticals as ophthalmic
solutions and list citric acid monohydrate as one of the ingredients. See Doc. No. 70-16 at 3; 7017 at 2. In addition, Defendant Lupin Ltd.’s ANDA equates “Citric Acid Monohydrate” in its
generic pharmaceutical to “Citric Acid” in Plaintiff’s Lumigan® 0.01% bimatoprost ophthalmic
solution. See Doc. No. 70-16 at 6. This extrinsic evidence demonstrates that a person of ordinary
skill in the art would understand that “citric acid monohydrate” describes an ingredient that
would be used to achieve an aqueous product containing citric acid. The extrinsic evidence, in
light of the intrinsic record, supports the adoption of Plaintiff’s proposed construction.
Defendants point to the sworn declaration of Mr. John Wurst, Plaintiff’s prosecution
attorney, as extrinsic evidence supporting their position. See Doc. No. 77-19 at 4. Defendants
argue that Mr. Wurst swore to the FDA that the ‘504 patent did not contain any product-byprocess claims. Defendants contend that Plaintiff’s current construction contradicts its prior
representations to the FDA. The Court disagrees. The Court finds that Mr. Wurst’s declaration is
consistent with Plaintiff’s proposed construction. Plaintiff only argues that the claims cover a set
of ingredients. Plaintiff’s construction does not mandate that a particular set of steps must be
completed in order to obtain the resulting composition. Accordingly, the Court finds Defendants’
argument regarding the extrinsic evidence without merit.
iv. Court’s Construction
In light of the claim language, the specification, the prosecution history, and the extrinsic
evidence, the Court adopts Plaintiff’s proposed construction. “[A] composition . . . which
comprises . . . citric acid monohydrate . . . wherein said composition is an aqueous liquid” means
Page 13 of 16
“a composition that is an aqueous liquid in which citric acid monohydrate is one of the materials
that is used to prepare the composition.”
b.
“about 0.014 citric acid monohydrate”3
Plaintiff’s Proposed
Construction
acid The term does not require
construction, but if the Court
chooses to construe the term,
it should construe it as
“approximately 0.014% citric
acid monohydrate”
Disputed Claim Term
“about 0.014
monohydrate”
citric
Defendants’ Proposed
Construction
“approximately 0.014% (w/v)
citric acid in crystalline form
containing only one water
molecule per molecule of
citric acid, where the water
molecules are incorporated
into the crystals”
The parties agree that “about” means “approximately” and that “0.014” means “0.014%
weight/volume.” The parties’ arguments regarding the remainder of the claim term are identical
to those presented for the previous phrase “a composition . . . which comprises . . . citric acid
monohydrate . . . wherein said composition is an aqueous liquid.”
For the same reasons stated above, the Court adopts a construction consistent with
Plaintiff’s proposal. “[A]bout 0.014 citric acid monohydrate” means “approximately 0.014%
weight/volume citric acid monohydrate.”
c. Agreed Constructions
In addition to the above disputed terms, the parties have come to several agreed
constructions. Based upon the joint submission of a claim construction chart, the parties agree to
the construction of the following terms. These constructions are therefore adopted by the Court:
3
The term “about 0.014 citric acid monohydrate” is found in the ‘504 patent at claim 3.
Page 14 of 16
‘504 Claim Terms
“phosphate buffer”
“about 0.01% bimatoprost”
“pH of about 7.3”
“about
200
ppm
benzalkonium
chloride”
“said composition is an aqueous liquid
which is formulated for ophthalmic
administration”
.
IV.
Agreed Constructions
No construction necessary4
“approximately 0.01% bimatoprost”
“pH of approximately 7.3”
“approximately 200 ppm benzalkonium
chloride”
“said composition is an aqueous liquid
that is formulated such that it can be
administered topically to the eye”
CONCLUSION
For the forgoing reasons, the Court adopts the constructions as set forth above, and as
listed in the attached chart.
It is SO ORDERED.
SIGNED this 10th day of January, 2013.
____________________________________
MICHAEL H. SCHNEIDER
UNITED STATES DISTRICT JUDGE
4
Although the parties agree that the term “phosphate buffer” requires no construction, they provide alternative
constructions should the Court believe construction is necessary. The Court agrees that “phosphate buffer” needs no
construction and that it should be afforded its plain and ordinary meaning.
Page 15 of 16
APPENDIX A
Location
Court’s Construction
“a composition . . . which
comprises . . . citric acid
monohydrate . . . wherein said
composition is an aqueous
liquid”
‘504 Patent, Claims 2 & 3
“a composition that is an
aqueous liquid in which citric
acid monohydrate is one of the
materials that is used to prepare
the composition”
“about 0.014 citric acid
monohydrate”
‘504 Patent, Claim 3
“approximately 0.014%
weight/volume citric acid
monohydrate.”
“phosphate buffer”
‘504 Patent, Claims 1–3
[Agreed] No construction
“about 0.01% bimatoprost”
‘504 Patent, Claims 1–3
[Agreed] “approximately 0.01%
bimatoprost”
“pH of about 7.3”
‘504 Patent, Claims 1–3
[Agreed] “pH of approximately
7.3”
“about 200 ppm benzalkonium
chloride”
‘504 Patent, Claims 1 & 2
[Agreed] “approximately 200
ppm benzalkonium chloride”
“said composition is an aqueous
liquid which is formulated for
ophthalmic administration”
‘504 Patent, Claims 1–3
[Agreed] “said composition is
an aqueous liquid that is
formulated such that it can be
administered topically to the
eye”
Claim Term
Page 16 of 16
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