Dey, L.P. et al v. Sepracor, Inc.
Filing
227
MEMORANDUM OPINION AND ORDER: The Court has considered all of the arguments raised by the parties. To the extent not specifically addressed above, the arguments are either moot or without merit. For the reasons explained above, the Court construes the disputed claim terms as indicated in the text of this Opinion. (Signed by Judge John G. Koeltl on 5/15/2012) (cd)
United States District Court
Southern District of New York
__________________________________
07 Civ. 2353 (JGK)
DEY, INC., ET AL.,
Plaintiffs,
MEMORANDUM OPINION
AND ORDER
- against SEPRACOR, INC.,
Defendant.
_____________________________________
JOHN G. KOELTL, District Judge:
This patent infringement action involves formoterol-based
pharmaceuticals that are used to treat chronic obstructive
pulmonary disease, or COPD.
The plaintiffs, Dey L.P., Dey,
Inc., and Mylan, Inc., (collectively, “Dey”), and the defendant,
Sunovion Pharmaceuticals, Inc. (“Sunovion”), are pharmaceutical
companies.
Dey alleges that Brovana, a pharmaceutical product
made by Sunovion, infringes several of its patents.
The Court
now construes certain disputed claim terms from the patents in
suit pursuant to Markman v. Westview Instruments, Inc., 517 U.S.
370 (1996) in preparation for the impending jury trial.
I.
Claim construction is a matter of law. See Markman v.
Westview Instruments, Inc., 52 F.3d 967, 970 (Fed. Cir. 1995)
(en banc) (citation omitted), aff’d 517 U.S. 370 (1996).
Courts
determine the scope of a claim by applying well-known principles
1
of claim construction and examining three relevant sources: the
language of the claim, the specification and the prosecution
history.
See Vitronics Corp. v. Conceptronic, Inc., 90 F.3d
1576, 1582 (Fed. Cir. 1996); see generally Phillips v. AWH
Corp., 415 F.3d 1303, 1312–17 (Fed. Cir. 2005) (en banc); see
also Hypoxico, Inc. v. Colo. Altitude Training, LLC, No. 02 Civ.
6191, 2008 WL 4129269, at *2 (S.D.N.Y. Sept. 4, 2008).
The language of a claim provides the starting point in a
claim construction analysis.
See Phonometrics, Inc. v. N.
Telecom Inc., 133 F.3d 1459, 1464 (Fed. Cir. 1998). “Absent a
special and particular definition created by the patent
applicant, terms in a claim are to be given their ordinary and
accustomed meaning.”
Renishaw PLC v. Marposs Societa’ Per
Azioni, 158 F.3d 1243, 1249 (Fed. Cir. 1998).
“[T]he 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 . . . .” Phillips, 415
F.3d at 1313.
The specification, however, is also highly relevant to the
claim construction analysis, because it is the best guide to the
meaning of a disputed term.
F.3d at 978).
Id. at 1315 (citing Markman, 52
While “it is the claims, not the written
description, which define the scope of the patent right,”
Laitram Corp. v. NEC Corp., 163 F.3d 1342, 1347 (Fed. Cir.
2
1998), “[u]ltimately, the interpretation to be given a term can
only be determined and confirmed with a full understanding of
what the inventors actually invented and intended to envelop
with the claim.
The construction that stays true to the claim
language and most naturally aligns with the patent's description
of the invention will be, in the end, the correct construction.”
Phillips, 415 F.3d at 1316 (citation and internal quotation
marks omitted).
A court in its discretion may also consider extrinsic
evidence, including expert and inventor testimony, dictionaries,
and learned treatises, in determining the meaning of claim
terms; however, the Court of Appeals for the Federal Circuit has
indicated that extrinsic evidence is less significant than the
intrinsic record and that courts should discount expert
testimony that is clearly inconsistent with the construction of
the claim indicated by the written record.
Phillips, 415 F.3d
at 1317–19.
II.
The facts in this case, with which the parties are presumed
to be familiar, are set forth in the Court's prior Opinion and
Order, Dey, Inc. v. Sepracor, Inc., --- F. Supp. 2d ---, No. 07
Civ. 2353, 2012 WL 678175 (S.D.N.Y. Mar. 1, 2012), and need not
be repeated here.
In the previous Opinion and Order, the Court
3
granted partial summary judgment to Sunovion with respect to the
second of the two families of patents at issue in this case
pursuant to 35 U.S.C. § 102(b), based on the finding that those
patents were invalid due to the prior public use of the claimed
invention.
Id. at *5-*9.
The Court also granted partial
summary judgment pursuant to 35 U.S.C. §§ 252 and 307 with
respect to any claimed damages from any alleged infringement of
Dey’s first family of patents that occurred prior to the
reexamination of those patents, because the independent claims
in those patents had been substantively changed in the
reexamination process.
Id. at *12-*16.
Thus, the Court need
only construe the post-reexamination language of the disputed
claims from Dey’s first family of patents.
Dey’s first family
of patents is composed of United States Patent Numbers 6,667,344
(the “’344 patent”) and 6,814,953 (the “’953 patent”).
The
claims at issue are independent claim 1 (“Claim 1”) of the ’344
patent, and independent claim 74 (“Claim 74”) of the ’953
patent; dependent claim 2 (“Claim 2”) of the ’344 patent, and
dependent claim 75 (“Claim 75”) of the ’953 patent, and
dependent claim 65 (“Claim 65”) of the ’344 patent.
and 74 were amended during reexamination.
issue were not.
4
Claims 1
The other claims at
III.
A.
Claim 1 claims:
A pharmaceutical composition, comprising
formoterol, or a derivative thereof, in a
pharmacologically suitable aqueous solution, wherein
the composition is stable during long term storage,
the composition is formulated at a concentration
effect[ive] for bronchodilation by nebulization, and
the composition is suitable for direct administration
to a subject in need thereof, without propellant and
without dilution of the composition prior to
administration.
See U.S. Patent No. 6,667,344, Reexamination Certificate C1
(8624th) (issued Oct. 11, 2011) (“’344 Patent Reexamination
Certificate”), at col. 1, ll. 31-39.
Claim 74 claims:
A method for the treatment, prevention, or
amelioration of one or more symptoms of
bronchoconstrictive disorders, comprising
administering an effective amount of a pharmaceutical
composition by nebulizer to a subject in need of such
treatment, wherein the pharmaceutical composition
comprises formoterol or a derivative thereof,
formulated at a concentration suitable for direct
administration to a subject in need of
bronchodilation, without propellant and without
dilution of the composition prior to administration,
wherein said formoterol or derivative is present in a
pharmacologically suitable aqueous solution, and
wherein the composition is stable during long term
storage.
5
See U.S. Patent No. 6,814,953, Reexamination Certificate C1
(8630th) (issued Oct. 18, 2011) (“’953 Patent Reexamination
Certificate”), at col. 1, l. 66–col. 2, l. 11.
Claim 1 claims a pharmaceutical composition, while Claim 74
claims a method for administering the composition.
However, the
language used in both claims to describe the properties of the
composition is the same, and it is that language which the
parties dispute, and which the Court must construe.
The parties
dispute the following terms in the two independent claims:
•
“pharmacologically suitable aqueous solution,”
•
“stable during long term storage,”
•
“formulated at a concentration effective for
bronchodilation by nebulization,” and
•
“formulated at a concentration suitable for direct
administration without propellant and without dilution
of the composition prior to administration.” 1
Claim 2 claims:
The pharmaceutical composition of [C]laim 1,
wherein the composition has an estimated shelf-life of
greater than one month usage time at 25° C. and
greater than or equal to 1 year storage time at 5° C.
1
The Court already construed much of the disputed language in
the independent claims in its previous Opinion and Order,
because it was necessary to construe the language from before
and after the reexamination, during which the independent claims
were amended, in order to determine whether the scope of the
independent claims had substantively changed. See Dey, 2012 WL
678175, at *11.
6
See U.S. Patent No. 6,667,344 (issued Dec. 23, 2003;
reexamination certificate issued Oct. 11, 2011) (“’344 Patent”),
at col. 17, ll. 58-61.
Claim 75 claims:
The method of [C]laim 74, wherein the composition
has an estimated shelf-life of greater than one month
usage time at 25° C. and greater than or equal to 1
year storage time at 5° C.
See U.S. Patent No. 6,814,953 (issued Nov. 9, 2004;
reexamination certificate issued Oct. 18, 2011) (“’953 Patent”),
at col. 21, ll. 59-62.
With respect to Claims 2 and 75, the
parties dispute the meaning of the term “shelf life.”
Claim 65 claims:
An article of manufacture, comprising packaging
material, an aqueous composition comprising the
composition of [C]laim 1 formulated for single dosage
administration, which is useful for treatment,
prevention or amelioration of one or more symptoms of
diseases or disorders associated with undesired and/or
uncontrolled bronchoconstriction, and a label that
indicates that the composition is used for treatment,
prevention or amelioration of one or more symptoms of
diseases or disorders associated with undesired and/or
uncontrolled bronchoconstriction.
’344 Patent at col. 21, ll. 27-36.
With respect to Claim 65, the parties dispute the following
claim terms:
•
“formulated for single dosage administration,” and
7
•
“a label that indicates that the composition is used
for treatment, prevention or amelioration of one or
more symptoms of diseases or disorders associated with
undesired and/or uncontrolled bronchoconstriction.”
The Court will construe each of the disputed claim terms in
turn.
B.
1.
The first issue is the meaning of the disputed term
“pharmacologically suitable aqueous solution.”
In its previous
Opinion and Order, the Court held that the scope of the
independent claims had substantively changed when the language
of the claims was amended from a “pharmacologically suitable
fluid” wherein “the fluid comprises water,” to a
“pharmacologically suitable aqueous solution.
678175, at *13-*14.
See Dey, 2012 WL
The Court held that this change was
substantive based in part on the prosecution history of the
reexamination.
During the reexamination, Dey distinguished its
claim from a phospholipid-based fluid that comprised 1.5% water
on the basis that the 1.5% water fluid was not “water-based.”
See id. at *14 (“The difference, Dey explained, was that an
aqueous solution is ‘water-based,’ and must contain more than
8
the 1.5% water found in a ‘phospholipid-based fluid’ such as
Maesen's.”).
Sunovion argues that the term “aqueous solution” is
indefinite, because the solution must contain more than 1.5%
water, but there is no way of knowing how much water it must
contain in order to be “aqueous.”
This argument is
unpersuasive, because, while Sunovion is correct that, based on
the prosecution history, the solution must contain at least 1.5%
water, it is not necessary to put an exact number on the amount
of water required for a solution to be “aqueous.”
See Conoco,
Inc. v. Energy & Envtl. Int’l, L.C., 460 F.3d 1349, 1355 (Fed.
Cir. 2006) (affirming the district court’s construction of a
mixture described in the patent specification as “aqueous” as
containing “more than negligible amounts of water”).
Moreover,
it is possible to arrive at a functional definition of a term
based on the intrinsic record.
A solution is a chemically and
physically uniform mixture that contains at least one solvent
and one solute, wherein the solute is dissolved into the
solvent.
See, e.g., Sears Petroleum & Transp. Corp. v. Archer
Daniels Midland Co., No. 03 Civ. 1120, 2007 WL 2156251, at *13
(N.D.N.Y. 2007) (noting the dictionary definition of “solution”
as a “homogeneous mixture of two or more substances, which may
be solids, liquids, gases, or a combination of these.” (quoting
American Heritage Dictionary 1655 (4th ed. 2000)).
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An aqueous
solution, then, is a solution in which the solvent, or a primary
solvent, is water.
See, e.g., id. (noting that the “[u]se of
the term ‘aqueous’ constricts the solution in issue . . . to a
liquid with water as a component, or even the primary solvent”
and construing the term to mean “a uniformly disbursed liquid
mixture of two or more components, one of which is water, and
which can contain incidental amounts of insoluble components”);
accord McGraw-Hill Dictionary of Scientific and Technical Terms
120 (5th ed. 1994) (defining aqueous solution as “[a] solution
in which the solvent is water”).
Dey proposes that the Court
construe the term as “a pharmacologically suitable solution in
which the solvent is water-based,” and the Court will adopt that
construction, with a few modifications.
First, as explained in the previous Opinion and Order, the
specifications, which were not amended during reexamination, no
longer completely match up with the amended claim language.
See
Dey, 2012 WL 678175, at *14 (“The terms of the specifications
indicate that some, but not all, of the fluids encompassed by
the original claim terms were ‘aqueous solutions’ or ‘aqueous
mixtures’, and therefore that some of the fluids encompassed by
the original claim language were not aqueous solutions.”).
Nevertheless, the specifications plainly indicate that cosolvents, in addition to water, may be present in the solution,
and the above-described plain meaning of “aqueous solution” is
10
consistent with that definition.
See, e.g., ’334 Patent at col.
9, ll. 6-14 (“Such solvents include, but are not limited to,
water or alcohols . . . .
Polar solvents also include protic
solvents, including, but not limited to, water, aqueous saline
solutions . . . , alcohols, glycols or a mixture thereof.”).
Second, given the above-described prosecution of the
patents during their reexamination, it is plain that an aqueous
solution, as that term is used in the claims at issue, must be
at least 1.5% water.
See Dey, 2012 WL 678175, at *14.
Indeed,
it is difficult to conceive of how “a pharmacologically suitable
solution in which the solvent is water-based,” could use a
solvent containing only negligible amounts of water.
Water must
be, if not the only solvent, then a primary or significant
(rather than incidental or negligible) solvent in the solution
for the solution to be “aqueous.”
However, the exact amount of
water will depend on the co-solvents used in a given aqueous
solution.
In any event, water must be a non-negligible, or even
primary, solvent.
See, e.g., Conoco, 460 F.3d at 1355.
The
term “aqueous solution” as used in the claims at issue is not
indefinite; it may be understood to require that water be a
significant or primary co-solvent in the solution, which is
consistent with the solvent being “water-based.”
This
definition necessarily takes into account the fact that a
11
solvent that is 1.5% water will not be sufficient to form an
aqueous solution within the meaning of the claim term.
The Court therefore adopts the following construction of
the disputed term “pharmacologically suitable aqueous solution”:
“A pharmacologically suitable fluid solution, where the
solvent is water-based (water is the solvent or a primary cosolvent), and where the solution may include co-solvents, such
as alcohols.”
Dey argues that the court should also construe a
“pharmacologically suitable aqueous solution” as one that is
“not a liquified propellant gas,” based on the language in the
specifications.
See, e.g., ’334 Patent at col. 5, ll. 15-17.
However, there is no basis for reading this additional
limitation into the construction of the claim term “aqueous
solution,” especially when other terms in the claim already
indicate that the method and composition claimed by the
independent claims are “without propellant.”
See, e.g.,
Smartmetric Inc. v. Am. Express Co., 2012 WL 1367398, at *1
(Fed. Cir. 2012) (summary order) (“The claims are read in
context with the specification, but limitations from the
specification should not be read into the claims.” (citing
Phillips, 415 F.3d at 1315, 1323)).
12
2.
a.
The next issue is the parties’ dispute over the term
“stable during long term storage” in the independent claims.
Dey argues that the Court should adopt the definition from the
specifications, which state that:
As used herein, the statement that a composition
is stable during “long term storage” means that the
composition is suitable for administration to a
subject in need thereof when it has an estimated
shelf-life of greater than 1, 2 or 3 months usage time
at 25° C. and greater than or equal to 1, 2 or 3 years
storage time at 5° C. In certain embodiments herein,
using Arrhenius kinetics, >80% or >85% or >90% or >95%
estimated bronchodilating agent remains after such
storage.
See, e.g., ’344 Patent at col. 6, l. 66 — col. 7, l. 6.
Sunovion argues that the Court should construe the term to
mean: “The composition has an estimated shelf life of greater
than 1 month usage time at 25° C. and greater than or equal to
one year storage time at 5° C., where shelf-life indicates the
length of time at a given temperature that greater than 80% of
the initial amount of the active ingredient, formoterol, is
present in the composition.”
The Court will adopt Sunovion’s
construction.
The parties have effectively admitted that there is no
practical difference between these two constructions.
See Apr.
12, 2012 Hr’g Tr. at 22 (“MR. HAUG: Right now I can’t point to
13
any significant difference at all.”).
However, a construction
which left multiple options for the percentages of formoterol
remaining over multiple periods of time at a given temperature
could confuse a jury, and force the jury impermissibly to
construe the claim.
Moreover, because there are dependent
claims covering the composition, “wherein greater than 80% of
the initial formoterol is present after 1 month usage time at
25° C. and one year storage time at 5° C,” see, e.g., ’344
Patent at col. 17, ll. 62-65, and the meaning of the independent
claims must be broad enough to include these dependent claims,
Dey, 2012 WL 678175, at *15 (citing AK Steel Corp. v. Sollac &
Ugine, 344 F.3d 1234, 1242 (Fed. Cir. 2003)), it would make
little sense to define the independent claim as potentially
requiring 85%, or 90%, of the formoterol to remain after 2 or 3
months at room temperature.
The independent claims must
encompass as little as 80% formoterol retention.
Dey argues that the Court should not construe “stable
during long term storage” as requiring at least 80% of the
initial formoterol be present in the composition at a given time
and temperature, because the specification says that “[i]n
certain embodiments herein,
. . . >80% or >85% or >90% or >95%”
of the formoterol will remain.
7, ll. 4-5.
See, e.g., ’344 Patent at col.
In other words, Dey argues that no specific amount
of formoterol should be required to remain because the
14
specification only says that specific amounts of formoterol
remain after a given period of time in “certain embodiments.”
However, nothing in the claim language, in the independent
claims or the dependent claims, indicates any embodiment where
less than 80% formoterol retention would still be considered
“stable during long term storage.”
Nor does Dey point to any
language in the claims or the specifications indicating how
else, aside from the specification language indicating a minimum
formoterol retention level of 80%, to tell if a sufficient
amount of formoterol is left in the composition so that it has
retained its properties and thus remains “suitable for
administration to a subject in need thereof” after a period of
storage.
Dey’s construction would thus invite the type of
ambiguity to which courts routinely apply a narrowing
construction. 2
See Halliburton Energy Servs., Inc. v. M-I
LLC, 514 F.3d 1244, 1253 (Fed. Cir. 2008) (“We note that where a
2
Moreover, to the extent that Dey presses the argument that the
doctrine of claim differentiation requires that the independent
claims include compositions that are “stable during long term
storage” despite a lower level of formoterol retention than that
described in the specifications and the dependent claims, the
Court of Appeals for the Federal Circuit has recently reiterated
that “claim differentiation is ‘not a hard and fast rule and
will be overcome by a contrary construction dictated by the
written description or prosecution history.’” Marine Polymer
Techs., Inc. v. HemCon, Inc., 672 F.3d 1350, 1359 (Fed. Cir.
2012) (en banc) (quoting Seachange Int'l, Inc. v. C–COR, Inc.,
413 F.3d 1361, 1369 (Fed. Cir. 2005)).
15
claim is ambiguous as to its scope we have adopted a narrowing
construction when doing so would still serve the notice function
of the claims.” (citing Athletic Alternatives, Inc. v. Prince
Mfg., Inc., 73 F.3d 1573, 1581 (Fed. Cir. 1996)).
The Court thus adopts the following construction of the
term “stable during long term storage”:
“The composition has an estimated shelf life of greater
than 1 month usage time at 25° C. and greater than or equal to
one year storage time at 5° C., where shelf-life indicates the
length of time at a given temperature that greater than 80% of
the initial amount of active ingredient, formoterol, is present
in the composition.”
b.
The parties also dispute the meaning of the term “estimated
shelf-life of greater than one month usage time at 25° C. and
greater than or equal to 1 year storage time at 5° C.” as it
appears in Claims 2 and 75.
The parties’ dispute with respect
to this term is largely the same as their dispute over the term
“stable during long-term storage.”
In addition, Dey argues that
“shelf-life” takes into account more than simply the “active
ingredient and how much is left over time.”
Tr. at 32.
Apr. 12, 2012 Hr’g
However, Dey points to no other such factors, aside
from the retention of formoterol, that are indicated in the
16
intrinsic record as being important to the definition of “shelflife.”
By contrast, the specifications do indicate that
formoterol retention over a given time period and temperature is
a factor (indeed the only mentioned factor) in determining
whether the composition has a sufficient “shelf-life” to be
“suitable for long term storage.”
col. 6, l. 66 — col. 7, l. 6.
See, e.g., ’344 Patent at
Dey argues that the Court should
follow the District Court for the Northern District of West
Virginia and construe the term shelf-life to mean “the period of
time during which a drug may be stored and remains suitable for
use.”
Dey, L.P. v. Teva Parenteral Meds., Inc., No. 09 Civ. 87,
2011 WL 2461888, at *12 (N.D.W.Va. June 17, 2011).
However, as
previously explained, this creates considerable ambiguity with
respect to how a competitor (or a jury) would know whether the
composition “remains suitable for use.”
A narrower
construction, based on the minimum formoterol retention levels
that the specifications and the claims indicate would render the
composition suitable for use, is thus appropriate in this case.
The Court therefore adopts the following construction of the
disputed claim term:
“Greater than approximately 80% of the initial formoterol
is present after more than 1 month usage time at 25° C. and
after at least 1 year storage time at 5° C.”
17
3.
The next issue is the parties’ dispute over the term
“formulated at a concentration effective for bronchodilation by
nebulization” in the independent claims. 3
Dey argues that the
term should be construed as having its plain meaning, and the
scope of the claim is essentially functional, including any
composition that is in fact effective for bronchodilation.
It
is true that a construction may properly be based on the
function performed by the claimed invention.
See Geneva
Pharms., Inc. v. GlaxoSmithKline PLC, 349 F.3d 1373, 1384 (Fed.
Cir. 2003) (“[A] functional limitation covers all embodiments
performing the recited function.”).
However, Dey ignores the
Court’s previous ruling on Sunovion’s motion for partial summary
judgment.
In that ruling this Court specifically explained
that:
As Dey explained during reexamination in
distinguishing prior art that had disclosed
formoterol compositions for an MDI inhaler, higher
concentrations of formoterol, like the 120–400 μg/mL
dose typically used with an inhaler, are ‘far more
3
Claim 74’s language is slightly different, and claims a method
for delivering “an effective amount of a pharmaceutical
composition by nebulizer to a subject in need of such treatment,
wherein the pharmaceutical composition comprises formoterol or a
derivative thereof, formulated at a concentration suitable for
direct administration to a subject in need of bronchodilation.”
’953 Patent Reexamination Certificate, at col. 1, l. 66–col. 2,
l. 11. The parties have not argued that this claim language in
the ’953 Patent differs substantively from the language in the
’344 Patent.
18
concentrated than what is acceptable for
nebulization’ and ‘far more concentrated than the
concentrations specified in independent claim 1.’
In other words, Dey explicitly disavowed during
reexamination formoterol concentrations exceeding
120 μg/mL from the scope of the independent claims,
despite the fact that the original independent
claims must have included formoterol concentrations
that greatly exceeded that amount.
Dey, 2012 WL 678175, at *16 (citations omitted).
Sunovion
argues that, based on the Court’s prior ruling with respect to
the prosecution history during the reexamination, Dey has
disavowed concentrations of formoterol greater than 120 μg/mL
from the scope of the independent claims because those
concentrations are unsuitable for nebulization.
correct.
Sunovion is
See Advanced Fiber Techs. (AFT) Trust v. J & L Fiber
Servs., Inc., 674 F.3d 1365, 1372-73 (Fed. Cir. 2012) (“[I]f a
patentee makes a clear and unambiguous disavowal of claim scope
during prosecution, that disclaimer informs the claim
construction analysis by ‘narrow[ing] the ordinary meaning of
the claim congruent with the scope of the surrender.’” (citation
omitted)). Because Dey disavowed such higher concentrations of
formoterol as ineffective for nebulization, the Court will
construe the disputed term as meaning “formulated at a
concentration of 120 μg/mL or less.”
This construction is
consistent with the scope of the dependent claims, which claim
19
formoterol concentrations of between 5 and 118 micrograms per
milliliter.
4.
The next issue is the parties’ dispute over the term
“formulated at a concentration suitable for direct
administration without propellant and without dilution of the
composition prior to administration.”
The parties do not dispute that this claim language covers
a composition that is not required to be diluted prior to
administration, i.e. one that is “ready to use.”
See Dey, 2012
WL 678175, at *13 (“[A] person of ordinary skill in the art
would understand the phrase ‘formulated at a concentration
suitable for direct administration’ to mean that the
compositions must be ‘ready to use,’ and that the compositions
are ‘ready to use’ when they can be administered without
diluting or mixing.” (quoting Dey v. Teva, 2011 WL 2461888, at
*7)).
Moreover, there is no dispute that a composition remains
within the claim even if it is in fact diluted prior to
administration, so long as the composition was ready to
administer without dilution prior to use.
Hr’g Tr. at 28.
See Apr. 12, 2012
Sunovion proposes that the Court construe the
disputed language to include that the composition be suitable
for direct administration without dilution “regardless of
20
whether or not the composition is actually diluted prior to
administration.”
Dey admits that this language accurately
describes the scope of the claim, but argues that it
unnecessary.
While “[t]he Markman decisions, in ruling that claim
construction is a matter of law for the court, do not hold that
the trial judge in a patent case must repeat or restate every
claim term in the court’s jury instructions,” “the district
court normally will need to provide the jury in a patent case
with instructions adequate to ensure that the jury fully
understands the court's claim construction rulings and what the
patentee covered by the claims.”
Sulzer Textil A.G. v. Picanol
N.V., 358 F.3d 1356, 1366 (Fed. Cir. 2004).
Thus, in patent
cases, “[j]ury instructions are reviewed not only for accuracy,
but for clarity, objectivity, and adequacy, taken as a whole.”
Id. at 1365.
Because there is admittedly no substantive
difference between the parties’ proposed constructions of the
disputed claim term, and because Sunovion’s construction more
clearly delineates the scope of the claim, the Court adopts the
following construction for the disputed claim term:
“The composition is suitable (i.e., acceptable or
appropriate) for administration without propellant and without
dilution regardless of whether or not the composition is
actually diluted prior to administration.”
21
5.
The next issue is the parties’ dispute over the term
“formulated for single dosage administration” in Claim 65.
Sunovion argues that the term means “designed for a single use,
rather than multiple uses.”
Dey argues that the term means
“formulated at a quantity that is taken or administered at one
time.”
The Court will adopt Sunovion’s construction.
There is no dispute that “formulated for single dosage
administration” means that the composition is designed for use
on a single-use dosage basis, that is, designed to be
administered from a container with a single dose of the
composition that an individual uses only once and cannot re-use.
The issue is whether “formulated for single dosage
administration” further requires that the composition be
formulated in single dose quantities, such that doses that are
formulated in a bulk solution and then divided into single dose
containers for single-dose administration are outside the scope
of the claim.
In essence, Dey argues that “formulated for
single dosage administration” should be read to mean “formulated
in single dose quantities.”
Nothing in the language of the claims or the specifications
indicates that this additional limitation should be read into
the claim.
Dey refers to “Example 2” in the specification,
22
which discusses the “preparation of [2 mL] formoterol unit dose
formulations,” and contrasts this with Example 1, which
discusses the “preparation of [2 liters of] formoterol
inhalation solution.” ’344 Patent at col. 17, ll. 1-35.
Dey
argues that the “unit dose formulation” in Example 2 exemplifies
how the composition would be “formulated for single dosage
administration,” and that the language in Example 2 and in Claim
65 is similar.
However, this language is not particularly
similar, and it makes little sense that the patentee would say
“formulated for single dosage administration” in Claim 65 in
order to indicate that the distinction between formulation in
“unit dose” quantities, as in Example 2, and formulation in bulk
quantities, as in Example 1, was somehow relevant to whether the
composition fell within Claim 65.
There is nothing in these
examples that would justify reading a numerical limitation with
respect to batch preparation size into Claim 65, see
Smartmetric, 2012 WL 1367398, at *1, and Dey does not propose a
specific limitation, such as 2 mL, or 5 mL, past which the
volume of the formulation makes it unsuitable for “single dosage
administration.”
While Dey argues that the court in West Virginia adopted
its proposed construction, the issue here—whether the
composition may be “formulated for single dosage administration”
when it is initially made in bulk—was not at issue in that case.
23
In the Teva case, the court held that “formulation ‘for single
dosage administration’ turns on a solution quantity to be taken
or administered at one time, and not a specific concentration of
formoterol.”
Dey v. Teva, 2011 WL 2461888, at *15.
There is no
dispute here that “for single dosage administration” means that
the composition is designed to be administered in the form of a
single, nonreusable dose that is “administered at one time.”
The Teva Court did not address Dey’s current argument, that the
composition must be initially “formulated in single doses,”
rather than in bulk.
Dey’s argument appears to be based on an anticipated prior
art defense.
See, e.g., Apr. 12, 2012 Hr’g Tr. at 34 (“THE
COURT: I thought Brovana is also packaged in single little vials
for --
. . . MR. HAUG: . . . It is for sure.
It’s a single
dose as is called for in this claim, and in that sense is the
same as Perforomist.
But Sunovion in earlier work, much earlier
work leading up to their final product maybe, they weren’t
making it in single doses.
They were making a pot of coffee;
not single shots of coffee.”).
This is an inappropriate basis
upon which to construe the scope of a patent claim, because
“[i]t is well settled that claims may not be construed by
reference to the accused device.”
NeoMagic Corp. v. Trident
Microsystems, Inc., 287 F.3d 1062, 1074 (Fed. Cir. 2002).
24
At bottom, Dey’s proposed construction seeks to substitute
“in single dose sizes” for the claim language “for single dosage
administration.”
The basic language of the claim does not
support that construction.
While Dey’s construction is
unsupported, Sunovion’s is uncontested.
There is no dispute in
this case that, in order for the composition to be “formulated
for single dosage administration,” it must be formulated such
that it can be packed, stored and ultimately administered in a
single dose, one-time use container.
Indeed, it must be
formulated “for” that type of administration. Accordingly, the
Court adopts the following construction for the disputed claim
term:
“Designed for a single use, rather than multiple uses.”
6.
The final issue is the parties’ dispute over the term “a
label that indicates that the composition is used for treatment,
prevention or amelioration of one or more symptoms of diseases
or disorders associated with undesired and/or uncontrolled
bronchoconstriction” in Claim 65.
The parties’ dispute centers around the distinction between
a label and labeling.
Sunovion proposed that the Court construe
a label as “a display of written, printed, or graphic matter
upon the immediate container surrounding the pharmaceutical
25
product.
To be distinguished from ‘labeling,’ which can include
written, printed or graphic matter accompanying a pharmaceutical
product, i.e., the package insert.” 4
Dey proposes that the Court
construe a “label” to mean “printed matter that states to a
doctor or patient that the composition is used for treatment,
prevention or amelioration.”
As an initial matter, there is very little in the intrinsic
record with which to resolve this dispute.
However, the
intrinsic record does support Sunovion’s construction.
Specifically, in describing “articles of manufacture” and
“packaging materials” as claimed in Claim 65, the ’344 Patent
cites as an example U.S. Patent No. 5,033,252 (the “’252
Patent”).
’344 Patent at col. 16, ll. 53-57.
The ’252 Patent
shows a “label” affixed directly to the container.
See U.S.
Patent No. 5,033,252, figs. 1-2 (issued July 23, 1991).
More importantly, Sunovion points out that the
label/labeling distinction is written into the Federal Food,
Drug and Cosmetic Act, a source with which a person possessing
ordinary skill in the art at the time would have been familiar.
Compare 21 U.S.C. § 321(k) (“The term ‘label’ means a display of
4
Sunovion additionally proposes: “That label must indicate that
the undesired and/or uncontrolled reduction in the caliber of a
bronchus or bronchi will be beneficially altered or lessened,
whether permanent or temporary, lasting or transient, by
administration of the composition.” There is no explanation why
this language is required for the label or is clearer than the
language set out in the claim.
26
written, printed, or graphic matter upon the immediate container
of any article.”), and id. at § 321(l) (“The term ‘immediate
container’ does not include package liners.”), with id. at §
321(m) (“The term ‘labeling’ means all labels and other written,
printed, or graphic matter (1) upon any article or any of its
containers or wrappers, or (2) accompanying such article.”);
accord United States Pharmacopeia 24th Revision 12
(2000)(attached as Ex. 25 to Hurd Claim Constr. Decl.) (“The
term ‘labeling’ designates all labels and other written, printed
or graphic matter upon an immediate container of an article or
upon, or in, any package or wrapper in which it is enclosed . .
. .
The term ‘label’ designates that part of the labeling upon
the immediate container.”).
Dey argues that defining label as the labeling affixed to
the immediate container makes no sense, because individual
dosage vials are only two inches long, and thus it would be
“impractical, if not impossible” to label each individual dose
within the meaning of Claim 65.
Apr. 12, 2012 Hr’g Tr. at 37.
However, Dey admits that the vials are approximately two inches
high, and have a circumference of somewhat less than two inches.
There is no showing that the vial could not include the 24-word
phrase “This composition is used for treatment, prevention or
amelioration of one or more symptoms of diseases or disorders
27
associated with undesired and/or uncontrolled
bronchoconstriction,” on a two by two inch space. 5
Because the Court concludes that a person of ordinary skill
in the art would take the term “label” to comport with
Sunovion’s construction, and because that construction is
consistent with the language of the claims and the
specifications, the Court will adopt Sunovion’s construction
with respect to this disputed claim term.
Accordingly, the
Court adopts the following construction for the disputed claim
term:
“A display of written, printed, or graphic matter upon the
immediate container surrounding the pharmaceutical product that
indicates that the composition is used for treatment, prevention
or amelioration of one or more symptoms of diseases or disorders
associated with undesired and/or uncontrolled
bronchoconstriction.”
5
Dey also argues that extrinsic evidence, in the form of
inventor testimony and various publications by entities such as
the Food and Drug Administration and the National Cancer
Institute, supports its argument that the label means the
package insert. However, the extrinsic publications that Dey
cites are far less authoritative than the definitions of
pharmaceutical labeling provided by the Food, Drug and Cosmetics
Act and the U.S. Pharmacopeia. Moreover, Dr. Chaudry’s
testimony is ambiguous, and Sunovion, too, cites Dr. Chaudry’s
deposition in support of its own position.
28
CONCLUSION
The Court has considered all of the arguments raised by the
parties. To the extent not specifically addressed above, the
arguments are either moot or without merit.
For the reasons explained above, the Court construes the
disputed claim terms as indicated in the text of this Opinion.
SO ORDERED.
Dated:
New York, New York
May 15, 2012
Judge
29
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