Alza Corporation et al v. Mylan Pharmaceuticals Inc. et al
Filing
127
MEMORANDUM OPINION AND ORDER CONSTRUING PATENT CLAIMS. Signed by District Judge Irene M. Keeley on 7/6/2015. (Copy counsel of record)(jmm)
IN THE UNITED STATES DISTRICT COURT
FOR THE NORTHERN DISTRICT OF WEST VIRGINIA
ALZA CORPORATION and JANSSEN
PHARMACEUTICALS, INC.,
Plaintiffs,
v.
//
CIVIL ACTION NO. 1:14CV85
(Judge Keeley)
MYLAN PHARMACEUTICALS, INC.,
Defendant.
MEMORANDUM OPINION AND ORDER CONSTRUING PATENT CLAIMS
This patent infringement case involves United States patent
8,163,798 (“the ‘798 patent”) issued to the plaintiffs, Alza
Corporation and Janssen Pharmaceuticals, Inc. (“Alza”). The claims
in the ‘798 patent, entitled “Methods and Devices for Providing
Prolonged Drug Therapy,” are undisputed save one phrase.
The patent-in-suit covers methods and devices for maintaining
a desired therapeutic drug effect over a prolonged therapy period,
specifically, oral dosage forms that release active pharmaceutical
ingredient
(“API”)
within
the
gastrointestinal
tract
at
an
ascending release rate over an extended time period. Some of these
dosage forms include an immediate-release dose of API.
Alza uses
the formulations and methods described in these patents in a
commercial product known as CONCERTA®.
I.
In
a
letter
dated
BACKGROUND
April
1,
2014,
the
defendant,
Mylan
Pharmaceuticals, Inc., (“Mylan”), notified Alza that it had filed
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an Abbreviated New Drug Application (“ANDA”) seeking United States
Food and Drug Administration (“FDA”) approval to market a tablet
containing
methylphenidate
hydrochloride
(“generic
tablet”).1
Mylan also filed a certification with the FDA alleging that certain
claims of the patent-in-suit are invalid and not infringed by
Mylan’s manufacture or sale of its generic tablet.
Alza responded
to Mylan’s ANDA by filing this patent infringement action against
Mylan pursuant to the Drug Price Competition and Patent Term
Restoration Act (the “Hatch-Waxman Act”).
See 21 U.S.C. §§ 355,
360cc; 35 U.S.C. §§ 156, 271.
In its complaint, Alza contends that the product described in
Mylan’s ANDA infringes claim 8 in the ‘798 patent, which is
dependent on claim 1.
The parties have identified one term from
claim 1 in need of construction for which they have proposed
competing claim constructions.
They also have submitted two (2)
agreed claim constructions. Following a claim construction hearing
and full briefing of the issues, for the reasons that follow, the
Court adopts the following construction.
1
In the original complaint, Alza had also named Mylan Inc. as
a defendant (Dkt. No. 1). The parties agreed to dismiss Mylan Inc.
on November 3, 2014 (Dkt. No. 48).
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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, the specifications, and
the prosecution histories as intrinsic evidence.
Id. (quoting
Unique Concepts, Inc. v. Brown, 939 F.2d 1558, 1561 (Fed. Cir.
1991)).
According
to
a
fundamental
principle
of
claim
construction, the invention itself, and the scope of a patentee’s
right of exclusion, will be defined by the patent’s claims.
See
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 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
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have to a person of ordinary skill in the art in question at the
time of the invention.”
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, then, a court must consider the
context
of
the
unasserted claims.
entire
patent,
Id. at 1314.
including
both
asserted
and
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
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
the
“‘best
4
source
for
understanding
a
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technical term.’”
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, ¶ 1, an inventor must use the specification to
describe his claimed invention in “full, clear, concise, and exact
terms.”
Accordingly, “[t]he claims of a patent are always to be
read or interpreted in the light of its specifications.” SchriberSchroth 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
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.
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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 establish “‘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).
It is with these legal principles in mind that the Court turns
to the construction of the disputed term in the patent-in-suit.
III.
CONCERTA®,
which
is
ANALYSIS
used
to
treat
attention
deficit
hyperactivity disorder (“ADHD”) and attention deficit disorder
(“ADD”) in children and adults, is a tablet consisting of an
immediate-release component and a sustained-release component. The
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immediate-release component “refers to a dose that is substantially
completely released within a time period of about 1 hour or less
and, preferably, about 30 minutes or less.”
9:27-28.
‘798 Patent, col.
The sustained-release component releases drug for an
extended time period wherein more of the API is released during the
second time interval than during the first time interval, and more
of the API is released during the third time interval than during
the second time interval.
‘798 Patent, col. 22:46-61.
According to Alza, CONCERTA® is an improvement over the prior
art because older treatments for ADHD/ADD, including Ritalin® and
Ritalin SR®, either require multiple administrations throughout the
day, or, in the case of extended-release tablets, diminish in
effectiveness throughout the day (Dkt. No. 72 at 8-9).
Studies
demonstrated that CONCERTA®, with its ascending release rate, “was
more effective than the flat plasma drug concentration profile in
controlling the symptoms of ADHD throughout the course of the day,
and was at least twice as effective as the twice-a-day dosing
regimen.”
‘798 Patent, col. 21:29-60.
The parties’ dispute stems
from claim 1 of the ‘798 patent, which claims an immediaterelease/sustained-release tablet.
Alza construes the disputed term, “said dosage form releases
said methylphenidate over a period comprising first, second, and
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third sequential one-hour time intervals,” as used in claim 1 of
the
‘798
patent,
to
mean
“said
dosage
form
releases
said
methylphenidate over a period comprising first, second, and third
sequential one-hour time intervals starting at the beginning of
dissolution testing.” Mylan construes it to mean “said dosage form
releases said methylphenidate over any three-hour period, in which
the three-hour period is divided into first, second, and third
sequential one-hour time intervals.”
A.
The Claims
Claim 1 of the ‘798 patent reads as follows:
1. An oral tablet dosage form for the treatment of
Attention
Deficit
Disorder
or
Attention
Deficit
Hyperactivity Disorder in a subject comprising:
an
immediate
release
portion
comprising
methylphenidate
or
a
pharmaceutically
effective salt thereof; and
a
sustained
release
portion
comprising
methylphenidate
or
a
pharmaceutically
effective salt thereof and a pharmaceutically
acceptable carrier,
wherein:
said dosage form releases said methylphenidate over
a period comprising first, second, and third
sequential one-hour time intervals, and
said sustained release portion releases more of
said methylphenidate during said second
interval than during said first interval, and
more of said methylphenidate during said third
interval than during said second interval.
‘798 Patent, 22:45-61 (emphasis added).
Alza argues that, under the plain language of claim 1, the
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“first, second, and third sequential one-hour time intervals”
clearly begin at the start of dissolution testing, or t=0 (Dkt. No.
72 at 16).
Claim 1 describes the tablet as being comprised of both
an immediate-release and a sustained-release portion. ‘798 Patent,
col.
22:45-61.
At
t=0,
or
the
time
of
administration,
the
immediate-release component of the tablet activates and begins to
release drug, which is completely released “within a time period of
about 1 hour or less and, preferably, about 30 minutes or less.”
‘798 Patent, col. 9:27-29.
Alza contends that, because the
immediate-release component necessarily releases during the first
time
interval,
or
t=1,
the
rest
of
“said
dosage
form,”
the
sustained-release component, also begins releasing during the
“first, second, and third sequential one-hour time intervals.” Id.
In other words, the reference in claim 1 to “said dosage
form,” defined as a dosage form comprised of immediate-release and
sustained-release components, necessarily means that the time
intervals are defined by reference to when the “dosage form” as a
whole begins releasing API.
The dosage form as a whole begins
releasing API at the beginning of dissolution testing, or t=0;
therefore, the “first, second, and third sequential one-hour time
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intervals” refer to t=1, t=2, and t=3.2
Mylan contests that dissolution testing begins immediately
when the dosage form is placed in the dissolution apparatus (Dkt.
No. 82 at 5-6).
It also argues that the plain language of claim 1
only provides that the product releases API during “any” three
sequential one-hour time periods, and not necessarily t=1, t=2, and
t=3 (Dkt. No. 78 at 15-16).
Mylan contends that many of the
examples in the specification establish an ascending release rate
for more than three hours, thus supporting its construction that
the sustained-release component could begin releasing API either at
t=0 or at a later point in dissolution testing.
In the Court’s view, the plain language of claim 1 supports
Alza’s proposed construction.
The inventors’ use of the term
“said,” with the common meaning “aforesaid” or “abovementioned,”
clearly indicates their intent to refer back to the dosage form
containing both immediate-release and sustained-release components.
2
Mylan’s argument that claim 2 of the ‘798 patent dictates a
contrary result is unpersuasive. Claim 2 provides for a dosage
form of claim 1 where the API released “during said first interval
only includes methylphenidate released from said immediate release
portion.” ‘798 Patent, col. 22:62-65. Because the Court presumes
that the independent claim 1 does not contain the limitations of
dependent claim 2, Phillips, 415 F.3d at 1313-14, it follows that,
in claim 1, the sustained-release portion begins to release drug
during “said first interval,” the same time when the immediaterelease portion is activated. The Court reaches this same result
by simply looking at the plain language of claim 1.
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Black’s Law Dictionary, 665 (4th pocket ed. 2011).
See Creative
Internet Advertising Corp. V. YahooA, Inc., 476 Fed. Appx. 724,
728-29 (Fed. Cir. 2011) (construing “said” to refer back to the
antecedent phrase); Intamin Ltd. v. Magnetar Techs. Corp., 483 F.3d
1328, 1333 (Fed. Cir. 2007) (“The use of the word ‘said’ in a claim
refers to an earlier use of the term in the claim.”).
“[S]aid”
dosage form, which comprises both immediate-release and sustainedrelease
components,
begins
releasing
API
commencement of dissolution testing, or at t=0.
9:27-37.
usually
immediately
upon
‘798 Patent, col.
This is so because the immediate-release component,
an
overcoat,
begins
dissolution testing begins.
to
dissolve
immediately
when
It follows logically that the other
half of “said dosage form,” the sustained-release component, also
begins releasing drug at t=0 at a rate that substantially ascends
over
the
“first,
second,
and
third
sequential
one-hour
time
intervals,” or t=1, t=2, and t=3.
Mylan’s proposed construction ignores the plain language of
the patent, particularly the antecedent term “said.” “A claim
construction that gives meaning to all the terms of the claim is
preferred over one that does not do so.”
Merck & Co., Inc. v. Teva
Pharms. USA, Inc., 395 F.3d 1364, 1372 (Fed. Cir. 2005) (internal
citations omitted).
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Furthermore, Mylan’s proposed construction makes little sense
given
the
inventors’
clear
intention
to
provide
“continuous
effective drug therapy over a prolonged therapy period.”
Patent, col. 10:45-46.
‘798
Under Mylan’s proposed construction, the
immediate-release portion would begin releasing API immediately, at
t=0, but the sustained-release portion could begin to release API
at any time, including hours after the drug had been released from
the immediate-release component. This result would create the same
“peaks and troughs” that plagued earlier inventions, and that the
inventors of CONCERTA® specifically avoided.
‘798 Patent, col.
21:42-48.
B.
The Specification
A closer examination of the patent specification further
supports Alza’s proposed construction.
Alza contends that every
reference to the “first, second, and third sequential one-hour time
intervals” in the specification of the ‘798 patent refers to the
first, second, and third one-hour intervals after the start of
dissolution testing (Dkt. No. 72 at 11-14, 18-20).
that
Alza
is
improperly
importing
limitations
Mylan argues
from
preferred
embodiments in the specification into the claim, and that, at any
rate, the specification never states that dissolution measurement
must begin at t=0 (Dkt. No. 82 at 5-6).
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Mylan’s argument that Alza is asking the Court to commit the
“cardinal sin” of claim construction is well-taken.
See Teleflex,
Inc. v. Ficosa N. Am. Corp., 299 F.3d 1313, 1324, 1326-28 (Fed.
Cir. 2002).
It is well-established that the Court cannot read
limitations from the specification into the claims.
Id. at 1326.
On the other hand, the claims must be interpreted in light of the
specification, which provides “context” for claim construction.
Id. at 1326-27. The United States Court of Appeals for the Federal
Circuit has explained that “an accused infringer cannot overcome
the ‘heavy presumption’ that a claim term takes on its ordinary
meaning simply by pointing to the preferred embodiment or other
structures or steps disclosed in the specification or prosecution
history.”
Id. at 1327 (citing CCS Fitness, Inc. v. Brunswick
Corp., 288 F.3d 1359, 1366 (Fed. Cir. 2002)).
This is not the
situation at bar, however; rather, the context provided by the
specification supports the plain language of claim 1.
The specification establishes that the inventors’ goal was to
control patients’ behavioral symptoms of ADD and ADHD during the
daytime, but discontinue therapy during the afternoon and evening
hours
due
to
the
side
effects
typically
associated
with
methylphenidate, a stimulant. ‘798 Patent, col. 6:62-67, col. 7:12.
They sought to accomplish this goal by designing a product
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with a substantially ascending release rate.
7:41-46.
‘798 Patent, col .
An ascending release rate solved the problems of (1)
peaks and troughs associated with multiple administrations of
immediate-release products, and (2) the delay in onset and lack of
efficacy associated with previous sustained-release products. ‘798
Patent, col. 7:5-40.
Given this background, the inventors designed a product with
an immediate-release “overcoat” that would immediately supply an
initial dose of the drug, and a sustained-release component that
would gradually become hydrated and begin releasing drug.3
Patent, col. 8:32-40.
‘798
The specification provides that the time of
drug administration is zero hours, or t=0, with each hour following
administration designated as t=1, t=2, and so on.
‘798 Patent,
col. 8:45-48. It also instructs that “in vitro drug release rates”
are to be obtained “at the specified time following implementation
of an appropriate dissolution test.”
‘798 Patent, col. 9:9-14.
Importantly, for a clinically effective ascending release rate
to be achieved, the product must release API at an ascending rate
“beginning at t=0 hours and continuing through at least the midpoint, and preferably beyond the midpoint, of the relevant T90 of
3
The sustained-release system differs from a delayed-release
delivery system like the one described by Mylan. ‘798 Patent, col.
2:50-52.
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the dosage form.”4
‘798 Patent, col. 10:9-20.
For example, if a
dosage form releases 90% of its drug at t=8, or eight hours after
administration, the ascending release rate of the drug should
continue through at least t=4.5
See ‘798 Patent, col. 10:11-31.
Although Mylan vigorously challenges the applicability of this
provision of the specification (Dkt. No. 82 at 6), it is useful to
provide the context within which claim 1 must be considered.
Teleflex, 299 F.3d at 1326-27.
Given
this
background,
and
without
even
considering
any
preferred embodiments, the Court concludes that the specification
squarely supports Alza’s proposed construction.6
invention,
to
concentration,
provide
would
an
be
effective,
undermined
The goal of the
long-lasting
by
Mylan’s
plasma
proposed
construction, which could result in the same peaks and troughs
specifically avoided by the inventors.
Furthermore, the clinical
4
T90 refers to the commonly-used reference measurement for
evaluating drug release from oral dosage forms. T90 for a dosage
form means the time at which 90% of drug within a dosage form has
been released. ‘798 Patent, col. 9:23-26.
5
As Alza mentioned during oral argument, claim 1 encompasses
an ascending release rate of at least three hours, but a product
with a longer ascending release rate would also infringe the claim.
6
Notably, however, every example in the specification
provides for an ascending release rate beginning at t=0.
See,
e.g., ‘798 Patent col. 14:25-35, col. 15:25-42, col. 16:45-68, col.
17:55-65, col. 20:36-50.
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effectiveness of the product depends upon an ascending release rate
that extends throughout the midpoint of the T90 of the dosage form.
It therefore makes no sense that claim 1 should cover a product
with an ascending release rate beginning at t=4 or t=5.
Finally,
the specification mentioned delayed release forms similar to those
mentioned by Mylan, but specifically declined to describe the
invention in those terms.
‘798 Patent, col. 2:50-52.
In short,
the specification comports with the plain language of claim 1.
C.
The Prosecution History
The
prosecution
history
of
the
undermines Mylan’s proposed construction.
patent-in-suit
further
Mylan argues that the
inventors stated that their claims were not limited to “the” second
time interval, but, rather, a “second or succeeding time interval,”
thus indicating their intent to broadly claim an ascending release
rate either at the beginning of or later during dissolution testing
(Dkt. No. 78 at 17). It also contends that the inventors abandoned
claims specifically referencing the release rate beginning at t=0.
Id. at 17-18.
According to Mylan, the prosecution history makes
clear that the inventors did not intend to limit the measurement of
“first, second, and third sequential one-hour time intervals” from
the beginning of dissolution testing.
Id. at 18.
Alza contends that the amendments made during prosecution are
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inapplicable to claim 1 because none of the cancelled claims
required a dosage form including an immediate-release component
(Dkt. No. 79 at 9).
The amendments, therefore, shed little light
on the scope of claim 1.
Id.
Alza submits that, after claim 1 was
added to the list of pending claims, it was not further amended
except to add the word “tablet.”
It
is
well-established
Id. at 10.
that
the
prosecution
history
may
provide insight into the meaning of a term or phrase, and that 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.
Phillips, 415 F.3d at 1317.
“[B]ecause the
prosecution history represents an ongoing negotiation between the
PTO and the applicant, rather than the final product of that
negotiation, it often lacks the clarity of the specification and
thus is less useful for claim construction purposes.”
Id.
If a
claim has a plain and ordinary meaning, the Federal Circuit has
found that “the specification and prosecution history only compel
departure from the plain meaning in two instances:
and disavowal.”7
lexicography
GE Lighting Solutions, LLC v. AgiLight, Inc., 750
7
Lexicography, which is not at issue here, refers to when a
patentee (1) clearly defines the disputed claim term, and (2)
clearly expresses an intent to define the term. GE Lighting, 750
F.3d at 1309.
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F.3d 1304, 1308-09 (Fed. Cir. 2014) (citing Thorner v. Sony
Computer Entm’t Am. LLC, 669 F.3d 1362, 1365 (Fed. Cir. 2012)). As
relevant here, the “exacting” standard for disavowal requires that
“the specification [or prosecution history] make[] clear that the
invention does not include a particular feature.”
Id. (quoting
SciMed Life Sys. Inc. v. Advanced Cardiovascular Sys., Inc., 242
F.3d 1337, 1341 (Fed. Cir. 2001)).
During prosecution, the inventors amended claims 35, 36, and
37 to include language measuring the release rate “from a first
periodic interval that begins at time t=0" to “about 5.5 to 8 hours
following said administration.”
37 C.F.R. § 1.116, at 2.
March 25, 2008, Reply Pursuant to
Mylan argues that those claims, which
were eventually cancelled, establish that the inventors knew how to
limit a claim, but affirmatively chose to not do so in the
remaining claims (Dkt. No. 78 at 17-18). See March 20, 2009, Reply
Pursuant to 37 C.F.R. § 1.116, at 2 (cancelling claims 36-39 and
41-44); March 25, 2008, Reply Pursuant to 37 C.F.R. § 1.116, at 2
(cancelling claim 35).
In October, 2009, the inventors added new claim 45, which
eventually issued with substantially the same language as claim 1.
October 15, 2009, Reply Pursuant to 37 C.F.R. § 1.116, at 2.
that time, claim 40, as amended, was still pending.
18
At
Claim 40
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provided
for
acceptable
“[a]
dosage
composition
form
comprising
comprising
a
pharmaceutically
methylphenidate
or
a
pharmaceutically acceptable salt thereof and a pharmaceutically
acceptable carrier, wherein said dosage form provides an ascending
release
rate
of
said
methylphenidate
beginning
with
a
first
periodic interval that begins at time t=0 and continuing through
Id. (emphasis
about 5.5 hours following said administration.”
added).
dosage
The inventors noted that new claim 45 is “directed to
forms
that
achieve
an
ascending
rate
of
release
of
methylphenidate from a first time interval to a second time
interval, and an ascending rate of release of methylphenidate from
the second time interval to third time interval.”
Id. at 6.
The patent examiner withdrew claims 45-51 as not reading on
the invention originally examined, and rejected claim 40.
Final Office Action, November 12, 2009, at 3.
Non-
The inventors
responded by arguing that, although claim 40 does not explicitly
include an immediate-release component, “the scope of that claim is
such that it includes this feature.”
January 7, 2010, Reply
Pursuant to 37 C.F.R. § 1.116, at 2.
The patent examiner eventually required restriction among
claim 40 and claims 45-51 pursuant to 35 U.S.C. § 121.
22, 2010, Reply Pursuant to 37 C.F.R. § 1.116, at 2.
19
See April
The inventors
ALZA, ET AL. V. MYLAN
1:14CV85
MEMORANDUM OPINION AND ORDER CONSTRUING PATENT CLAIMS
then elected to pursue pending claims 45-51, which ultimately
issued as claims 1-7 of the ‘798 patent.
April 22, 2010, Reply
Pursuant to 37 C.F.R. § 1.116, at 2.
Although cancelled claim 40, which provided for an ascending
release of drug beginning at t=0, did not specifically include an
immediate-release component, the inventors argued for such an
application.
See January 7, 2010, Reply Pursuant to 37 C.F.R. §
1.116, at 2 (arguing that, although claim 40 does not explicitly
include an immediate-release component, “the scope of that claim is
such that it includes this feature”).
Importantly, that they did
so supports Mylan’s argument that the inventors had a claim that 1)
specifically provided for an ascending release rate beginning at
t=0,
and
2)
at
least
arguably
included
an
immediate-release
component.
It is clear, however, that the inventors affirmatively chose
to proceed with claims 45-51, and not claim 40.
Reply Pursuant to 37 C.F.R. § 1.116, at 2.
April 22, 2010,
Claim 45 explicitly
included both immediate-release and sustained-release components,
thus clarifying the uncertainty in claim 40.
It also included
plain language indicating that “said dosage form” releases the API
over three sequential one-hour intervals.
As explained above,
these three time intervals begin at the start of dissolution
20
ALZA, ET AL. V. MYLAN
1:14CV85
MEMORANDUM OPINION AND ORDER CONSTRUING PATENT CLAIMS
testing, or t=0.
See GE Lighting Solutions, 750 F.3d at 1308-09
(stating that the prosecution history must make it clear that the
invention does not include a particular feature in order to disavow
the plain language of the claim).
In claim 45, the inventors took
out the specific reference to t=0, but added language indicating
when the ascending release should begin.
The Court therefore
rejects Mylan’s invitation to rely on the prosecution history to
contravene the plain language of claim 1.
IV.
CONCLUSION
For the reasons discussed, the Court CONSTRUES the contested
claim term as follows:
1.
“[S]aid dosage form releases said methyphenidate over a
period comprising first, second, and third sequential
one-hour time intervals” means “said dosage form releases
said methylphenidate over a period comprising first,
second, and third sequential one-hour time intervals
starting at the beginning of dissolution testing.”
Further,
the
Court
adopts
the
parties’
agreed
claim
constructions and CONSTRUES the following terms and phrases as
follows:
1.
“Releases” means “releases according to an in-vitro
dissolution test;” and,
21
ALZA, ET AL. V. MYLAN
1:14CV85
MEMORANDUM OPINION AND ORDER CONSTRUING PATENT CLAIMS
2.
“Said dosage form is osmotic” means “said oral tablet
utilizes osmotic pressure to generate a driving force for
imbibing fluid into a compartment formed, at least in
part, by a semipermeable wall that permits free diffusion
of fluid but not drug or osmotic agents.”
It is so ORDERED.
The Court directs the Clerk to transmit copies of this Order
to counsel of record.
DATED:
July 6, 2015.
/s/ Irene M. Keeley
IRENE M. KEELEY
UNITED STATES DISTRICT JUDGE
22
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