DEPOMED, INC. v. BANNER PHARMACAPS INC. et al
Filing
108
OPINION. Signed by Judge Jose L. Linares on 3/26/2015. (anr)
NOT FOR PUBLICATION
UNITED STATES DISTRICT COURT
DISTRICT OF NEW JERSEY
DEPOMED, INC.,
Plaintiff,
Civil Action No. 13-04542 (JLL) (JAD)
v.
OPINION
BANNER PHARMACAPS INC. and
WATSON LABORATORIES, INC.,
Defendants.
LINARES, District Judge.
This matter comes before the Court by way an application for claim construction
by
Plaintiff Depomed, Inc., (“Plaintiff’) and Defendants Banner Pharmacaps Inc., and
Watson
Laboratories, Inc. (Collectively “Defendants”). The parties seek construction of certain
language
contained in claim 13 of United States Patent No. 7,662,858 (the” ‘858 Patent”) and
claim 12 of
United States Patent No. 7,884, 095 (the” ‘095 Patent”); and claim 15 of the ‘095
Patent. The
Court held a Markman hearing on March 3, 2015. The Court has considered the parties
’ written
and oral arguments and sets forth herein its construction of the disputed claim terms.
I. BACKGROUND
This is a Hatch Waxman Litigation involving a generic version of Plaintiffs brand
name
drug “Zipsor”. Zipsor is used in the treatment of pain, including bunionectomy pain.
Buionectomy is surgical procedure which removes a bunion. Zipsor is a 25mg,
liquid filled,
diclofenac capsule that allows diclofenac to stably remain in suspension and quickly
disperse
upon release in the stomach to prevent aggregation. Diclofenac is a nonsteroidal antiinflammatory drug used to treat pain and inflammation associated with arthritis. Zipsor is
protected by 7 patents listed in the Orange Book. The seven patents in suit can be divided into
two groups: two composition patents which cover the composition of the liquid filled, diclofe
nac
capsules and five method patents which describe the method of using the diclofenac tablets for
the treatment of pain conditions. Only the ‘858 and the ‘095 method patents raise a specific
claim construction dispute other than the general dispute that unconstrued claims should
be given
their plain and ordinary meaning.
While the parties have agreed to constructions of a number of claim terms, the parties
dispute the interpretation of language in claims 13 and 12 of the ‘858 Patent and the ‘095 Patent
,
respectively; as well as language in claim 15 of ‘095 patent. The parties ask the Court to give
the
proper construction of “NPRS” and “average 48 hour NPRS score” within the meaning of
method claims 13 of the ‘858 Patent and claim 12 of the ‘095 patent and the proper constru
ction
of “Clinically significant”, within the meaning of claim 15 of the’095 patent.
II. LEGAL STANDARD
A court’s analysis of a patent infringement claim is two-fold. Tate Access Floors, Inc. v.
Interface Architectural Resources, Inc., 279 F.3d 1357, 1365 (Fed.Cir.2002). The court
must first
define the meaning and scope of the patent claims as a matter of law. Markman v. West-view
Instruments, Inc., 52 F.3d 967, 978 (Fed.Cir.1995) (en bane), affd, 517 U.S. 370, 116
S.Ct.
1384, 134 L.Ed.2d 577 (1996). The court then engages in a comparison of the claims
as
construed to the alleged infringing product (or method). Tate, 279 F.3d at 1365. At this
stage, the
Court must only engage in the first step.
Claim construction is a matter of law to be determined solely by the court. Phillips v.
A WI-I Corp., 415 F.3d 1303, 1312 (Fed.Cir.2005), cert. denied, 546 U.S. 1170, 126 S.Ct.
1332,
164 L.Ed.2d 49 (2006). “It is a bedrock principle of patent law that the claims of patent
a
define
the invention to which the patentee is entitled the right to exclude.” Id. at 13 12 (quota
tions
omitted). In construing the terms of a patent, a court should look first to the language of
the
claim itself. Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1582 (Fed.Cir.1996
). The terms
in the claim “are generally given their ordinary and customary meaning.” Id. at 1582.5
“[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, i.e., as of the
effective
filing date of the patent application.” Phillips, 415 F.3d at 1313. A court “must look at
the
ordinary meaning in the context of the written description and the prosecution history
.” Medrad,
Inc. v. MRI Devices Corp., 401 F.3d 1313, 1319 (Fed.Cir.2005). The court should turn
to “those
sources available to the public that show what a person of skill in the art would have
understood
disputed claim language to mean. “Innova/Pure Water, Inc. v. Safari Water Filtrati
on Sys., Inc.,
381 F.3d 1111, 1116 (Fed.Cir.2004).
To this end, the court should first examine the intrinsic record-the patent itself,
including
the claims, the specification and, if in evidence, the prosecution history. Vitron
ics, 90 F.3d at
1582 (citing Markman, 52 F.3d at 979). The specification “acts as a dictionary
when it expressly
defines terms used in the claims or when it defines terms by implication.” Id.
Indeed, the Federal
Circuit has explained that the specification is” ‘usually
...
dispositive
...
[and] the single best
guide the meaning of a disputed term.’ “Phillips, 415 F.3d at 1315 (quoting
Vitronics, 90 F.3d at
1582). It is “entirely appropriate for a court, when conducting claim constru
ction, to rely heavily
on the written description for guidance as to the meaning of the claims.” Id.
at 1317. The
specification is also an important guide in claims construction as it may contain “an intentional
disclaimer, or disavowal, of claim scope by the inventor.” Id. at 1316.
Additionally, the court should consult the patent’s prosecution history as it “provides
evidence of how the PTO and the inventor understood the patent.” Id. Courts should be
circumspect in reviewing a prosecution history as it represents “an ongoing negotiation betwee
n
the PTO and the applicant, rather than the final product of the negotiation
....“
Id. A district court
may also examine extrinsic evidence: “all evidence external to the patent and prosecution
history.” Markman, 52 F.3d at 980; Phillips, 415 F.3d at 1317—18 (stating that the Federal
Circuit “ha[sj authorized district courts to rely on extrinsic evidence”). Such evidence consists
of
testimony by the inventor or by experts, dictionaries, and treatises. Markman, 52 F.3d at 980.
In
particular, a court may find reference to technical dictionaries useful “in determining the
meaning of particular terminology.” See Phillips, 415 F.3d at 1318. However, extrinsic evidence
is generally thought to be less reliable than the patent and prosecution history, id. at 1318—19; in
essence, it is “less significant than the intrinsic record in determining the legally operative
meaning of claim language,” C.R. Bard, Inc. v. US. Surgical Corp., 388 F.3d 858, 862
(Fed.Cir.2004) (quotation omitted). With this framework in mind, the Court now turns
to the
disputed claim language.
III. DISCUSSION
A. “NPRS” and “Average 48 hour NPRS score”
The claim terms “NPRS” and “average 48 hour NPRS pain score”, appear in claim
13 of
the ‘858 Patent which is dependent upon claim 12 which in turn, is dependent upon
claim 1. The
claim language for the ‘858 patent, with the disputed terms indicated by emphasis,
is as follows:
1. A method of treating acute post-bunionectomy pain in a patient in need
of such treatment, said method comprising orally administering to the
patient a dose of between about 13 to about 25 mg of diclofenac potassium
in a dispersible liquid formulation about every 4 hours to about 8 hours over
a period of at least 24 hours, wherein the daily total amount of diclofenac
potassium administered is less than or equal to about 100 mg.
12. The method according to claim 1, wherein the amount of the diclofenac
potassium in the dispersible liquid formulation comprises about 25 mg of
diclofenac potassium.
13. The method according to claim 12, wherein the administration of
diclofenac potassium in the dispersible liquid formulation results in an
average 48 hour NPRS pain score of about 2.49.
Moreover, the claim terms “NPRS” and “average 48 hour NPRS pain score” appear in
claim 12 of the ‘095 Patent which is dependent upon claim 11 which in turn, is dependent upon
claim 1. The relevant claim language for the ‘095 patent is:
1. A method of treating acute post-osteotomy pain in a patient in need of
such treatment, said method comprising orally administering to the patient a
dose of between about 13 to about 25 mg of diclofenac potassium in a
dispersible liquid formulation about every 4 hours to about 8 hours over a
period of at least 24 hours, wherein the daily total amount of diclofenac
potassium administered is less than or equal to about 100 mg, wherein the
osteotomy is correction of a bone deformity.
11. The method according to claim 1, wherein the amount of the diclofenac
potassium in the dispersible liquid formulation comprises about 25 mg of
diclofenac potassium.
12. The method according to claim 11, wherein the administration of
diclofenac potassium in the dispersible liquid formulation results in an
average 48 hour NPRS pain score of about 2.49.
“NPRS” stands for “Numerical Pain Rating Scale”. Plaintiff’s proposed definition of
NPRS is “an 11 point numerical pain rating scale from 0-10”. Alternatively, Defendants’
proposed definition of NPRS is “a pain intensity rating scale that uses a numerical rating such as
0-10, 0-5, 0-4 or a visual scale with both words and numbers”. For the term “average 48 hour
NPRS pain score”, Plaintiff proposes the term be constructed as, “the average pain intensity over
a 48 hour multiple dose period using an NPRS pain score”. Defendants’ proposed construction
reads, “the average 48 hour pain intensity score on a pain rating scale that uses numerical rating
such as 0-10, 0-5, 0-4, or a visual scale with both numbers and words”.
Plaintiff argues that the claim language expressly supports their construction. Plaintiff
states that the claim’s limitation of an “average 48 hour NPRS pain score of about 2.49” pain
score requires that the NPRS limitation itself have a definite range, rather than several possible
ranges. Plaintiff contends that because the language refers to a specific average score of 2.49
over 48 hours, the score would lose meaning if used on a different scale. (Tr. Of Proceedings,
March 3,2015 [“Hr’g Tr.”j, 10:10-23). Plaintiff also asserts that the claim language is tied into
the specification. Plaintiff points to a specific example, example 2, in the specification which
uses 2.49 as the score taken over a 48 hour period by using an 0 to 10 scale. (Hr’d Tr., 11:1012:1).
Defendants in turn argue that their proposed construction largely tracks the definition of
NPRS as set forth in the specification: “the numerical pain rating scale refers to a numerical
rating of 0-10 or 0-5 or to a visual scale with both words and numbers.” Defendants state that
during the prosecution of both patents, the applicants explained that the clinical study of example
2 used a primary efficacy endpoint, “determined by an NPRS of 0-10 where 0 represents
no pain
and 10 represents the worst possible pain”. By the using the word “an” rather than “the”,
Defendants contend that both the applicants and the expert who used the same phrase
acknowledged that there is more than one kind of numerical pain rating scale.
Defendants state that Plaintiff’s proposed construction is too constrictive and contrary to
the open-ended definition for NPRS in the specification which states: “The numerical pain rating
scale (NPRS) refers to an numerical rating of 0-10 or 0-5 or to a visual scale with both words
and
numbers.” (Def’s Opening Brief at 8-9). Defendants state that Plaintiff’s proposed construction
improperly deletes the second and third alternatives in this definition. Defendants counter
Plaintiff’s argument by stating that while example 2 in the specification of the ‘858 and ‘095
patents used the 0-11 scale to determine the efficacy of the claimed methods of treatment, this
data is merely exemplary. (Id. at 9). Defendant contends that it does not state anywhere
in the
specification that the NPRS used in example 2 is limited only to the scale used in examp
le 2.
Additionally, Defendants assert that the dispute presented by “average 48 hour NPRS
score” is whether it should be construed to require a multiple dose period and whether it should
be construed to require a dose period lasting 48 hours. Defendants argue that Plaintiff’s propos
ed
construction would create a “multiple dose period requirement”, which Defendants conten
d is
unnecessary because the claims already require more than one dose of diclofenac to be
administered (claim 1 of each patent requires diclofenac to be administered at least every
8 hours
over 24 hours). Defendants contend that Plaintiff’s proposed construction unnece
ssarily limits
the methods of claim 13 in the ‘858 patent and claim 12 in the ‘095 patent by requiri
ng that
diclofenac be dosed over a 48 period. Defendants state that, as written, both claims allow
dosing
to cease afler at least 24 hours, and the patent provides no reason why 48-hour averag
e NPRS
score cannot include NPRS scores taken afier dosing ceases.
After due consideration of Defendants’ and Plaintiff’s arguments, the Court conclu
des
that Plaintiff’s proposed construction is proper. In construing the terms of a patent, this
Court
looks first to the language of the claim itself. Vitronics, 90 F.3d 1576, 1582 (Fed.C
ir.1996). In
the case at bar, while the language of the claim itself does not expressly indicate that a scale of 010 should be used when determining the average pain intensity over a 48 hour multiple dose
period using an NPRS pain score, it does clearly state that the administration of diclofenac
“results in an average 48 hour NPRS pain score of about 2.49.” “The context of the surrounding
words of the claim also must be considered in determining the ordinary and customary meaning
of those terms.” ACTV, 346 F.3d 1082, 1088 (Fed. Cir. 2003). With that principle in mind, the
Court is compelled to adopt Plaintiff’s argument regarding the context of the 2.49 score. Were
the Court to adopt Defendants’ proposed construction, the 2.49 NPRS score would become
inappropriately ambiguous when considering the surrounding context. The meaning of a score
of
2.49 takes on a significantly different implication when considered in the context of 0-10 scale,
as opposed to the context of a 0-4 scale. While a score of 2.49 on a scale of 0-10 may indicate to
a person of ordinary skill in the art that the patient was reporting a low pain rating, that score
results in an entirely different connotation when offered using a different scale, such as the 0-4
scale proposed by Defendants.
Moreover, the Federal Circuit explains that the specification is “usually
...
dispositive
[and] the single best guide to the meaning of a disputed term.’ “Fhillips, 415 F.3d at 1315
(quoting Vitronics, 90 F.3d at 1582). Here, Plaintiff has tied the patents’ specifications
to the
relevant claim language in a manner sufficient to convince the Court that it is appropriate
to
adopt its proposed construction. The Court is cognizant, as Defendants note, that langua
ge in the
specification includes a 0-5 scale. However, as Plaintiff correctly argues, Defendants ignore
the
very next sentence in the specification, which states, “the patient is being asked to rate the pain
with 0 being no pain and 10 being the worst possible pain”. Therefore, looking at the
specification in its entirety, this previously cited sentence gives significance and contex
t to the
2.49 NPRS score included the claim term. Were the Court to only consider the first
sentence
Defendants cite in the specification, the claim term would not only lose its intend
ed inference, as
demonstrated by the following sentence in the specification, but the Court’s analys
is would run
afoul of the holding in Phillips. 415 F.3d, 1313. (“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 specifi
cation.”) See
also Merck & Co. v. Teva Pharms. USA, Inc., 347 F.3d 1367, 1371 (Fed.Cir.2003
)(”{C]laims
must be construed so as to be consistent with the specification, of which they are
a part.”)
The Court also adopts Plaintiff’s proposed construction of the disputed term “avera
ge 48
hour NPRS pain score”, which is, “the average pain intensity over a 48 hour multip
le dose period
using an NPRS pain score”. As Plaintiff argued in its briefs and at the March 3, 2015
Markman
hearing, in Table 2, Column 17 of the ‘858 Patent, a score of 2.49 was record
ed over a 48 hour
multiple dose period, using an 11 point NPRS, 0-10 scale. (‘858 Patent, 17:4750.) While the
Court is mindful and has considered Defendants’ argument that Plaintiff’s propos
ed construction
may seek to import limitations from example 2 into the disputed claims, the
Court is nevertheless
satisfied that this is not the case. The express claim language makes referen
ce to an average
score of 2.49 over a 48 hour period, which is achieved by giving a patient
multiple doses over 48
hours, as evidenced in example 2 of the specification. Throughout the Patents
’ specifications, it
is taught that the 48-hour pain score is the average taken over a 48 hour
period, using an 11
point, 0-1ONPRS scale. (See e.g. ‘858 Patent, 16:28-34; 17:1-3; 17:6266; l1:48-51.)(Emphasis
added). This language in the specification explains how the claim elemen
t “48 hour multiple
dose period” is to be determined. As noted above, when analyzing the
specification in its
entirety, this previously cited language in the specification gives signifi
cance and context to the
language, “48 hour multiple dose period” included the claim term. Therefore, based upon this
analysis, the Court adopts Plaintiff’s proposed claim construction for the disputed claim
terms
“NPRS” and “average 48 hour NPRS pain score”.
B. “Clinically Significant”
The claim term “clinically significant” appears in claim 15 of the ‘095 patent, which is
dependent upon claim 11, which in turn, is dependent upon claim 1. Plaintiff’s propos
ed
construction defines “clinically significant” as a 30% reduction in pain intensity
as compared to a
placebo. Defendants offer no construction of the term. The relevant claim language
for the ‘095
patent is as follows, with the disputed term indicated by emphasis:
“The method according to claim 11, wherein the administration of
diclofenac potassium in the dispersible liquid formulation provides
clinically significant analgesic efficacy for about 6 hours.”
Plaintiff maintains that the claim term “clinically significant” modifies the term
“analgesic efficacy” and requires that such clinically significant “analgesic efficac
y” be
maintained for 6 hours. Moreover, Plaintiff argues, the claim language does not
require that the
efficacy begin with the first treatment nor that it initiate at the beginning of the 6
hour window.
Plaintiff contends that the specification defines it using their proposed construction:
“30%
reduction in pain intensity” is defined as “clinically significant analgesic efficac
y”. Plaintiff
further notes that no other portion of the specification uses the express claim langua
ge “clinically
significant analgesic efficacy,” except at the outset where it refers to an embod
iment. Plaintiff
states that this embodiment defines “clinically significant analgesic efficacy”
as a 30% reduction
in pain intensity.
Defendants argue that the term “clinically significant” does not need to be construed
because a person of ordinary skill in the art would understand and be able to apply this
phrase
without further elaboration. Defendants’ expert states that the term is an omnibus term
used to
refer to anything deemed by the patient, the caregiver, or the investigator as having
practical
impact on the quality of medical care, patient experience, andlor the overall outcome of
treatment. Defendants argue that Plaintiff’s proposed construction does not clarify the
meaning
of “clinically significant,” but rather, it improperly narrows the general phrase to specifi
a
c
quantitative value.
Defendants point to the specification, which states that “pain is highly subjective
to the
individual experiencing it” and “the goal of post-surgical pain management is to
provide a quick
onset of analgesic or pain relief’ and “educe or modulate the quality and intensi of
ty pain a
patient experiences”. Defendants argue that the specification also distinguishes
between an
embodiment involving a 30% pain reduction and an embodiment providing “clinic
ally
significant analgesic efficacy”. The specification also suggests that an analgesic
effect can be
clinically significant if it reduces opioids, therefore, Defendants contend, to a POSA
, reducing or
delaying reliance on opioids in treating acute pain is a clinically significant analge
sic effect
Defendants state that Plaintiff’s proposed construction seems to rely on langua
ge from
the clinical study reported in example 2 of the ‘858 patent. Example 2 describes
a clinical study
that evaluated analgesic efficacy of a diclofenac treatment regimen. The study
employed several
measures to assess efficacy, including pain intensity, pain relief on a scale,
time to meaningful
pain relief, time to perceptible pain relief, and a global assessment of the study
of medication.
The specification explains for purposes of the study, “clinically significant
analgesic analysis
efficacy was defined as both, greater than or equal to 30% reduction from baselin
e pain intensity
using NPRS, and meaningful relief as indicated by a stopwatch method.” To determine
meaningful relief using the stopwatch method, subjects were handed a stopwatch shortly after
receiving medication (diclofenac or placebo) and instructed to “stop the stopwatch when
you
have meaningful pain relief, that is, when the relief from pain is meaningful to you.” Defendants
argue that even if the definition of clinically significant analgesic efficacy” in example 2 is found
to define the meaning of “clinically significant” in claim 15 of ‘095 patent, Plaintiffs propos
ed
construction is still at odds because: 1) Plaintiff’s proposed construction ignores the latter half
of
the definition (“meaningful relief”), and 2) the first half of the study compares pain intensi
ty to
baseline where Plaintiff’s proposed definition compares pain intensity to placebo which
Defendants contend are entirely different.
The Court agrees with Plaintiff. When attaching the claim term, “clinically significant”
to the specification and the claim language itself, the Court finds it appropriate to adopt
Plaintiffs proposed construction. While Defendants and their expert are correct in pointin
g out
that “clinically significant” may have other possible meanings, this is not the case when
this
language read in the context of the specification as required by Phillips. 415 F.3d, 1313.
(“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 contex
t of the
entire patent, including the specification.”) Further, the fact that the definition might
have several
meanings demonstrates to this Court that the term should be construed using the langua
ge of the
specification as required under Phillips, as it may clear any inappropriate ambigu
ity.
The specification expressly states that for, “[ejvaluation of the frequency and timing
(defined as time of meaningful pain relief) of obtaining clinically significant analge
sic efficacy
(defined as a 30% reduction in pain intensity) as compared to placebo in acute pain;”.
(‘095
Patent, Col. 11, II. 64-67). The specification “acts as a dictionary when it expressly
defines terms
used in the claims or when it defines terms by implication.” Vitronics, 90 F.3d at 1582
(citing
Markman, 52 F.3d at 979). Here, the specification is expressly defining what
the claim term
“clinically significant” means in the context of the ‘095 patent. The language
of the claim calls
for “clinically significant analgesic efficacy” to be achieved for 6 hours. The specifi
cation does
not contain any other language in which the Court could reasonably infer that
the clinically
significant efficacy achieved for the 6 hours be defined as anything other
than a reduction of pain
intensity by 30%.
Moreover, while Defendants’ argument regarding the multiple definitions for
“clinically
significant” offered in the specification is well-taken, but fails for several reason
s. The
specification states, “Evaluation evaluate the frequency of timing (define
d as time of meaningful
pain relief) of obtaining clinically significant analgesic efficacy (defined
as a 30% reduction in
pain intensity) as compared to placebo in acute pain.” (‘858 Patent, 11 :61-64
)(Emphasis added).
Here, Plaintiff has shown how the specification demonstrates that the claim
term at issue is
compared to a patient who received a placebo, as opposed to a baselin
e comparison. Plaintiff
furthered its point in this regard when it emphasized that Defendants’
expert agreed that the
specification used a placebo comparison. (Hr’g Tr., 29:15-30:9).
Similarly, as Plaintiff correctly reasoned, the example in the specifi
cation that Defendants
call attention to did not deal with a 6 hour durational requirement as
the claim language in
question calls for. That example only asked a subject to stop a stopwa
tch when that person felt
the onset of meaningful relief. It did not refer to the duration of
pain relief, for which claim 15 of
the ‘095 patent requires. Defendants’ expert Dr. Loeser acknowledged
as much when deposed by
Plaintiff:
[Q:] Meaningful relief, as determined by the stopwatch method, that
refers to the onset of meaningful relief; correct?
A. Yes.
Q. That does not refer to the duration of pain relief; correct?
A. Yes.
Q. And we can agree that Claim 15 of the ‘095 patent requires that
there be meaningful clinically significant analgesic efficacy over six hours;
correct?
MR. MADDOX: Object to form.
THE WITNESS: Yes.
BY MR. GAEDE:
Q. And that’s a duration requirement; correct?
A. Yes.
(ECF No. 62-3; Loeser Depo. Tr.) at 67:14-68:4) In construing the terms of
a patent, a court
should look first to the language of the claim itself. Vitronics, 90 F.3d 1576,
1582. Within the
claim language at issue, a 6 hour durational requirement is called for. The Court
cannot construe
the claim term at issue without considering that durational requirement
that lies within the claim
language. The section of the specification that Defendants rely on does
not refer to a multiple
dose period as Claim 15 requires. Defendants section refers to a “single
dose test”. This is
outside the scope of Claim 15, which calls for a 6 hour, multi-dose period
. “The context of the
surrounding words of the claim also must be considered in determining the ordina
ry and
customary meaning of those terms.” ACTV, 346 F.3d 1082, 1088 (Fed. Cir. 2003). In this
case,
the surrounding context of the claim term at issue is not tied into the specification langua
ge that
Defendants rely on. Further, the section of the specification in which Plaintiff relies
upon
expressly defines what the claim term at issue is to mean within the scope of the claim.
Therefore, based upon this analysis, the Court adopts Plaintiff’s proposed claim constru
ction for
the disputed claim term “clinically significant”.
IV. CONCLUSION
For the foregoing reasons, the Court construes the disputed terms of United States
Patent
Nos. 7,662,858 and 7,884,095 as follows:
1. The terms “NPRS” and “Average 48 Hour NPRS” as used in claim 12 of the ‘095
Patent and claim 13 of the ‘858 patent are construed to mean “an 11 point numer
ical pain rating
scale from 0-10” and “the average pain intensity over a 48 hour multiple dose period
using an
NPRS pain score”;
2. The term “clinically significant” as used in claim 15 of the ‘095 Patent is constru
ed to
mean “a 30% reduction in pain intensity as compared to a placebo.”
An appropriate Order accompanies this Opinion.
Date: March 26, 2015
/5/
Jose L. Linares
Jose L. Linares
United States District Judge
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