HORIZON PHARMA, INC. et al v. DR. REDDY'S LABORATORIES INC. et al

Filing 82

OPINION/ORDER re: appl. for claim construction by Pltfs. in three patents. Horizon, DRL and Lupin seeking construction of terms in U.S. Patent No. 8,945,621 (the 621 patent); etc Signed by Judge Stanley R. Chesler on 11/14/17. (DD, )

NOT FOR PUBLICATION
UNITED STATES DISTRICT COURT
DISTRICT OF NEW JERSEY
_______________________________________________

:
HORIZON PHARMA, INC., HORIZON
:
PHARMA USA, INC., and POZEN INC.,
:
:
Plaintiffs,
:
:
v.
:
:
DR. REDDY’S LABORATORIES, INC.
:
and DR. REDDY’S LABORATORIES,
:
:
Defendants.
:
_______________________________________:
:
HORIZON PHARMA, INC., HORIZON
:
PHARMA USA, INC., and POZEN INC.,
:
:
Plaintiffs,
:
:
v.
:
:
MYLAN PHARMACEUTICALS INC.,
:
MYLAN LABORATORIES LIMITED, and
:
MYLAN, INC.,
:
:
Defendants.
:
_______________________________________:
:
HORIZON PHARMA, INC., HORIZON
:
PHARMA USA, INC., and POZEN INC.,
:
:
Plaintiffs,
:
:
v.
:
:
LUPIN LTD. and LUPIN
:
PHARMACEUTICALS INC.,
:
:
Defendants.
:
_______________________________________:
CHESLER, U.S.D.J.

Civil Action No. 15-3324 (SRC)
OPINION & ORDER

(consolidated for discovery
purposes with Civil Action
Nos. 16-4918, 16-9035,
15-3327, 16-4921, 15-3326,
and 16-4920)

This matter comes before the Court on the application for claim construction by
Plaintiffs Horizon Pharma, Inc., Horizon Pharma USA, Inc., and Pozen Inc. (collectively,
“Horizon”) and Defendants Dr. Reddy’s Laboratories Inc. and Dr. Reddy’s Laboratories Ltd.
(collectively, “DRL”), Mylan Inc., Mylan Laboratories Limited, and Mylan Pharmaceuticals Inc.
(collectively, “Mylan”), and Lupin Ltd. and Lupin Pharmaceuticals Inc. (collectively, “Lupin”).
In this patent infringement suit involving eleven pharmaceutical patents related to the drug
Vimovo®, the parties seek construction of claims in three patents. Horizon, DRL and Lupin seek
construction of terms in U.S. Patent No. 8,945,621 (“the ’621 patent”). All parties seek
construction of terms in U.S. Patent Nos. 9,220,698 (“the ’698 patent”) and 9,393,208 (“the ’208
patent”). The Court held a Markman hearing on November 7, 2017.
ANALYSIS
I.

The law of claim construction
A court’s determination “of patent infringement requires a two-step process: first, the court

determines the meaning of the disputed claim terms, then the accused device is compared to the
claims as construed to determine infringement.” Acumed LLC v. Stryker Corp., 483 F.3d 800,
804 (Fed. Cir. 2007). “[W]hen the district court reviews only evidence intrinsic to the patent (the
patent claims and specifications, along with the patent’s prosecution history), the judge’s
determination will amount solely to a determination of law.” Teva Pharms. USA, Inc. v. Sandoz,
Inc., 135 S. Ct. 831, 841 (2015).
The focus of claim construction is the claim language itself:
It is a bedrock principle of patent law that the claims of a patent define the
invention to which the patentee is entitled the right to exclude. Attending this
principle, a claim construction analysis must begin and remain centered on the
claim language itself, for that is the language the patentee has chosen to
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‘particularly point[] out and distinctly claim[] the subject matter which the patentee
regards as his invention.’
Innova/Pure Water, Inc. v. Safari Water Filtration Sys., 381 F.3d 1111, 1115-1116 (Fed. Cir.
2004) (citations omitted).
The Federal Circuit has established this framework for the construction of claim language:
We have frequently stated that the words of a claim ‘are generally given their
ordinary and customary meaning.’ We have made clear, moreover, that the
ordinary and customary meaning of a claim term is the meaning that the term
would have to a person of ordinary skill in the art in question at the time of the
invention, i.e., as of the effective filing date of the patent application.
The inquiry into how a person of ordinary skill in the art understands a claim term
provides an objective baseline from which to begin claim interpretation. . .
In some cases, the ordinary meaning of claim language as understood by a person
of skill in the art may be readily apparent even to lay judges, and claim
construction in such cases involves little more than the application of the widely
accepted meaning of commonly understood words. In such circumstances, general
purpose dictionaries may be helpful. In many cases that give rise to litigation,
however, determining the ordinary and customary meaning of the claim requires
examination of terms that have a particular meaning in a field of art. Because the
meaning of a claim term as understood by persons of skill in the art is often not
immediately apparent, and because patentees frequently use terms
idiosyncratically, the court looks 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. Those sources include the words of the claims themselves, the remainder of
the specification, the prosecution history, and extrinsic evidence concerning
relevant scientific principles, the meaning of technical terms, and the state of the
art.
Phillips v. AWH Corp., 415 F.3d 1303, 1312-1314 (Fed. Cir. 2005) (citations omitted).
II.

Claim construction of the disputed terms
A.

The ’621 patent

The parties had originally briefed three terms in the ’621 patent: “coordinated release,”
“more effective,” and “reducing the incidence.” Just before the Markman hearing, the parties
agreed that: 1) “coordinated release” should have the same construction as previously established

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in regard to the ’907 patent; and 2) “reducing the incidence” need not be construed. This leaves
only “more effective” at issue.
The phrase “more effective” appears toward the end of claim 1 in the ’621 patent:
. . . wherein said pharmaceutical composition in unit dose form reduces the
incidence of NSAID-associated ulcers in said patient and wherein administration of
the unit dose form is more effective at reducing the incidence of the
NSAID-associated ulcers in patients taking LDA than in patients not taking LDA
who are administered the unit dose form.
At the hearing, it became clear that the parties have no actual dispute about the meaning of the
phrase, “more effective,” and they agree that it should have its ordinary meaning. The dispute
between the parties instead concerned Defendants’ argument that the claim is nonsensical and
therefore indefinite, but these are not issues to address at claim construction. “More effective” has
its ordinary meaning.
B.

The ’698 and ’208 patents

The parties dispute the construction of three terms in the ’698 and ’208 patents: “±20%,”
“target,” and “mean area under the plasma concentration-time curve.” The parties seek
construction of these terms in the two patents, but focused on the ’698 patent in briefing and at the
hearing. The ’698 patent has one independent claim:
1. A method for treating osteoarthritis, rheumatoid arthritis, or ankylosing
spondylitis comprising orally administering to a patient in need thereof an AM unit
dose form and, 10 hours (±20%) later, a PM unit dose form, wherein:
the AM and PM unit dose forms each comprises:
naproxen, or a pharmaceutically acceptable salt thereof, in an
amount to provide 500 mg of naproxen, and
esomeprazole, or a pharmaceutically acceptable salt thereof, in an
amount to provide 20 mg of esomeprazole;
said esomeprazole, or pharmaceutically acceptable salt thereof, is released from
said AM and PM unit dose forms at a pH of 0 or greater,
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the AM and PM unit dose forms target:
i) a pharmacokinetic (pk) profile for naproxen where:
a) for the AM dose of naproxen, the mean Cmax is 86.2 ng/mL
(±20%) and the median Tmax is 3.0 hours (±20%); and
b) for the PM dose of naproxen, the mean Cmax is 76.8 ng/mL
(±20%) and the median Tmax is 10 hours (±20%); and
ii) a pharmacokinetic (pk) profile for esomeprazole where:
a) for the AM dose of esomeprazole, the mean area under the plasma
concentration-time curve from when the AM dose is administered to
10 hours (±20%) after the AM dose is administered (AUC0-10,am) is
1216 hr*ng/mL (±20%),
b) for the PM dose of esomeprazole, the mean area under the plasma
concentration-time curve from when the PM dose is administered to
14 hours (±20%) after the PM dose is administered (AUC0-14,pm) is
919 hr*ng/mL (±20%), and
c) the total mean area under the plasma concentration-time curve for
esomeprazole from when the AM dose is administered to 24 hours
(±20%) after the AM dose is administered (AUC0-24) is 2000
hr*ng/mL (±20%); and
the AM and PM unit dose forms further target a mean % time at which intragastric
pH remains at about 4.0 or greater for about a 24 hour period after reaching steady
state that is at least about 60%.
A note about terminology: in the art, “PK profile” refers to a pharmacokinetic profile,
basically statements of characteristics of levels of the active ingredient in blood plasma, showing
the absorption of the active ingredient by the body. “PD profile” refers to a pharmacodynamic
profile, basically statements of the resulting effect on the body, such as raising the stomach pH a
certain amount. Claim 1 states targets in terms of certain PK characteristics (plasma levels of
active ingredients) and certain PD characteristics (levels of intragastric pH).
1.

“±20%”

The parties dispute whether “±20%” in claim 1 has its ordinary arithmetic meaning (plus
or minus 20%), or is a “coefficient of variation” (“CV”), as defined in the specification. The term
“±20%” appears in claim 1 in 10 places: half are time values (hours ±20%), and half are plasma
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concentration values (Cmax or AUC ±20%). Defendants propose that “±20%” has its ordinary
arithmetic meaning when modifying time values, but a special meaning (CV) when modifying
plasma concentration values. There is no dispute that, as to the time values, “±20%” has its
ordinary arithmetic meaning.
On first blush, Defendants seem to make a strong case for the CV construction: Defendants
point out that, in a section which states principles of general applicability, the specification states:
“With regard to the pharmacokinetic and/or pharmacodynamic values provided herein, the degree
of variation is reflected in SDs and % CV values. The %CV = SD/mean x 100.” ’698 patent,
col.5 ll.53-56. There is no dispute that Cmax and AUC are pharmacokinetic (“PK”) values.
Defendants, however, have overlooked the full context of that statement in the
specification:
With regard to the pharmacokinetic and/or pharmacodynamic values provided
herein, the degree of variation is reflected in SDs and % CV values. The %
CV=SD/mean x 100; the SD=(% CV x mean) divided by 100. It can be expected
that approximately 68% of patients will be within one SD of the mean and
approximately 95% of patients will be within two SDs of the mean. The
pharmacokinetic and pharmacodynamic values presented herein are average values,
rounded to the nearest whole number, and are based upon results obtained from
multiple individuals. As a result, the values presented herein may vary from one
patient to another. This variation is reflected in the term ‘about.’
’698 patent, col. 5 ll.53-64. When the sentence quoted by Defendants is read in context, the
context shows that this applies only “to results obtained from multiple individuals.” ’698 patent,
col.5 ll.61-62. It therefore applies only to PK or PD values that state results from groups of
patients, such as results of research studies. It does not apply to results from a single patient. The
preamble of claim 1 states: “A method for treating osteoarthritis, rheumatoid arthritis, or
ankylosing spondylitis comprising orally administering to a patient in need thereof . . .”

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(emphasis added). The PK and PD limitations in claim 1 apply to that single patient, not to results
from multiple individuals.1
Furthermore, as Plaintiffs point out, the prosecution history shows that the applicants
substituted “±20%” in claim 1 (then claim 19) for the word “about.” (Beel Dec. Ex. 5 at 5.) The
applicants stated, in regard to this change: “This amendment is supported Applicants’
specification [sic] at, for example, page 6, lines 17-18.” (Id.) This citation refers to this statement
in the draft specification: “For the values provided herein, the term ‘about’ indicates a given
number may vary by at least 5%, with variations of 10%, 15% or 20% being possible.” (Beel Dec.
Ex.7 at 6.) Note that the applicants did not refer to the next paragraph in the draft specification
which, like the specification in the issued patent, is the paragraph quoted above about PK values
and the coefficient of variation. This statement in the prosecution history supports the
understanding that the applicants intended “±20%” to mean a simple arithmetic percentage –
roughly equivalent to “about” – , rather than a coefficient of variation.
Plaintiffs also point out that claim 1 uses “±20%” in reference not only to PK and PD
values, but also in regard to time periods. In short, the CV concept has no applicability to – and,
rather, makes no sense if applied to – time periods. “[T]he same word appearing in the same
claim should be interpreted consistently.” Dig. Biometrics, Inc. v. Identix, Inc., 149 F.3d 1335,

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At the hearing, counsel for Plaintiffs argued that the PK and PD profile values in claim
1 are summary statistics for groups of patients. This position conflicts with the preamble
language that specifies that what is claimed is a method of treatment for “a patient.” Plaintiffs
have not pointed to anything in the patent that shows that what the inventors actually invented
was a method for treating a group of patients. See Renishaw PLC v. Marposs Societa' Per
Azioni, 158 F.3d 1243, 1250 (Fed. Cir. 1998) (“Ultimately, 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.”)
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1345 (Fed. Cir. 1998).
Furthermore, in the specification, where the inventors meant to refer to the CV, they wrote
out, “% CV” or “% coefficient of variation.” See, e.g., ’698 patent, Figure 7; col.8 ll.12-13;
Tables 4, 5, 6. Defendants have not pointed to any place in the specification that “±20%” appears
and has the meaning, “a CV of 20.”
“±20%” has its ordinary meaning, “plus or minus 20 %.”
2.

“target”

Claim 1 contains the term “target” in two places: “the AM and PM unit dose forms target:”
and “the AM and PM unit dose forms further target.” Plaintiffs contend that “target” has its
ordinary meaning, and that that ordinary meaning is “produce.” At oral argument, the Court
inquired as to how “produce” is the ordinary meaning of “target.” In reply, Plaintiffs explained
that what they meant is that “produce” is the meaning that would be understood by the skilled
artisan in the context of this patent. In support, Plaintiffs point to the declaration of their expert,
Dr. Taft, who states that opinion. (Taft Dec. ¶ 28.) Plaintiffs also cite this statement in the ’698
specification: “This, and similar, formulations can be effective in improving NSAID tolerability
through dosages of esomeprazole and naproxen that produce the desired pharmacodynamic
response and pharmacokinetic values.” ’698 patent, col.1 ll.34-37. Plaintiffs also point to a place
in the specification in which an embodiment is said to target a particular PD profile. ’698 patent,
col.6 ll.46-56.
The Court finds Plaintiffs’ proposed construction unpersuasive. At the hearing, Plaintiffs
offered nothing to counter the Court’s suggestion that the ordinary meaning of “target” is not
“produce,” except for the argument, based on extrinsic evidence, that the skilled artisan would

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understand it that way. Under Federal Circuit law, “conclusory, unsupported assertions by experts
as to the definition of a claim term are not useful to a court.” Phillips, 415 F.3d at 1318. Dr.
Taft’s assertion is the kind of conclusory, unsupported assertion that, under Phillips, is not useful
in claim construction.
The only intrinsic evidence cited by Plaintiffs is the specification passage in which the
treatment method is described as producing certain PD and PK profiles, as well as one in which
the treatment method is said “to target” a specific PD profile. The Court does not see how this
supports Plaintiffs’ position. For example, if the specification of a car suspension patent states
that the design “delivers” a smooth ride, and also that the design “creates” a smooth ride, that is
not evidence that “deliver” means “create.”
It is certainly clear that the inventors believed that the patented method should, at some
point and in some way, produce the stated PD and PK profiles – as Plaintiffs demonstrate, the
specification makes that clear. But that does not resolve this issue. As the Federal Circuit has
stated, “the claims, not the specification, provide the measure of the patentee’s right to exclude.”
Johnson & Johnston Assocs. v. R.E. Serv. Co., 285 F.3d 1046, 1052 (Fed. Cir. 2002). “It is the
claims that define the metes and bounds of the patentee’s invention.” Kara Tech. Inc. v.
Stamps.com Inc., 582 F.3d 1341, 1347 (Fed. Cir. 2009). Thus, an underlying concern in claim
construction is ascertaining the metes and bounds of the patentee’s invention that are stated in the
claim. Plaintiffs’ proposed construction does not appear to clarify how the patentees drew those
boundaries.
During oral argument, this was apparent when Plaintiffs seemed to contend that the PK
and PD profile values in claim 1 are average values that are obtained from some unspecified group

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of patients. If this is Plaintiffs’ position, it makes no sense. As already noted, the preamble of
claim 1 states: “A method for treating osteoarthritis, rheumatoid arthritis, or ankylosing
spondylitis comprising orally administering to a patient in need thereof . . .” (emphasis added).
Plaintiffs’ position conflicts with this: how could the treatment of a single patient target PK and
PD values that are averages from some unknown group?2 Moreover, if this is the case, how does a
skilled artisan determine whether or not a particular treatment of a particular individual patient has
met the limitations of claim 1? Does one have to treat a group of patients and then compare the
average values for the group to the values stated in claim 1? Is this a hypothetical group of
patients? In terms of understanding the metes and bounds of the claims, this is a path to
confusion.
In sum, Plaintiffs did not shed light on the meaning of “target” in claim 1.
Defendants contend that “target” is indefinite. This Court considers indefiniteness
arguments on summary judgment or at trial, and not at claim construction. Defendants propose, in
the alternative, that if the Court does not find the term indefinite, it has its ordinary meaning,
which is, “with the goal of obtaining.”
Thus, both sides propose that “target” has its ordinary meaning, but they differ on what
that ordinary meaning is. Defendants point to a number of dictionary definitions of target: “to
establish as a target or a goal” (Beel Dec. Ex. 8), “establish as a goal” (Beel Dec. Ex. 9), and “to
establish as a target, goal, etc.) (Beel Dec. Ex. 10). These three dictionary definitions agree that

2

The Court recognizes that the specification states: “The pharmacokinetic and
pharmacodynamic values presented herein are average values, rounded to the nearest whole
number, and are based upon results obtained from multiple individuals.” ’698 patent, col.5 ll.5962. This is clearly true as applied to research results, such as disclosed in Table 6. The parties
did not address the question of whether this also applies to claim 1.
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“target” means “to establish as a goal.” Unlike Plaintiffs’ proposed meaning, this fits with the
Court’s understanding of what “target” ordinarily means. This construction also fits with claim 1
and the patent as a whole: the PK and PD profiles in claim 1 appear to be goals for the treatment
method of claim 1. If Plaintiffs are correct in their contention that the PK and PD values in claim
1 are averages for a group, the claim, using this construction, makes sense: one administers the
method to an individual patient with the goal of obtaining these values, on average, for a group of
patients. From this perspective, the PK and PD profiles in claim 1 do not serve as limitations for
the method, but as statements of a goal aspired to, but not met, for every patient.3
This Court agrees with Defendants’ proposed construction, “with the goal of obtaining.”
In the context in which “target” appears in claim 1, that exact wording has a poor grammatical fit
(since “target” functions as a verb in claim 1, and “with the goal of obtaining” is a prepositional
phrase.) To improve the grammatical fit, this Court construes “target” in claim 1 to mean: “set as
a goal.”
This Court recognizes the general canon of claim construction that claims should be
construed so as to preserve their validity. While this Court today makes no determination about
the validity of claim 1, at the same time, the Court recognizes that this construction of “target”
could conceivably impact the validity of the claim. On this record, however, this Court sees no
alternative. Plaintiffs’ proposed construction makes no sense, and Defendants’ proposed
construction makes sense. Moreover, the Federal Circuit does not apply this canon of

3

Defendants argued separately that the PK and PD values in claim 1 are non-limiting,
offering a number of arguments in support, including one focused on the relationship between
claim 1 and Table 6 in the specification. This Court need not reach any of these arguments at
this juncture in order to construe the claim term, “target.” The Court does not, today, decide the
question of whether the PK and PD profiles in claim 1 are or are not limiting.
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construction in every case, but limits it to certain circumstances:
This court has frequently alluded to the familiar axiom that claims should be so
construed, if possible, as to sustain their validity. At the same time, however, the
court has admonished against judicial rewriting of claims to preserve validity.
Accordingly, unless the court concludes, after applying all the available tools of
claim construction, that the claim is still ambiguous, the axiom regarding the
construction to preserve the validity of the claim does not apply.
Liebel-Flarsheim Co. v. Medrad, Inc., 358 F.3d 898, 911 (Fed. Cir. 2004) (citations omitted).
Because this Court does not find the term “target” to be ambiguous, it need not contemplate
rewriting the claim to preserve its validity.
3.

“mean area under the plasma concentration-time curve”

The parties dispute whether “mean area under the plasma concentration-time curve”
(“mean AUC”) is limited to a steady state value. Defendants seek to import a narrowing
limitation from certain embodiments in the specification. There is no basis in the claim language
for Defendants’ proposed narrowing construction. “[A]lthough the specification often describes
very specific embodiments of the invention, we have repeatedly warned against confining the
claims to those embodiments.” Phillips, 415 F.3d at 1323. Claim 1 contains a different limitation
which specifies “after reaching steady state,” and the specification includes examples in which the
steady state characteristic is expressly stated, showing that the patentees knew how to state that
characteristic when they intended it to apply. “Mean area under the plasma concentration curve”
will be given its ordinary meaning, without the narrowing construction Defendants propose.

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In conclusion, in claim 1 of the ’698 and ’208 patents, “±20%” and “mean area under the
plasma concentration-time curve” have their ordinary meaning, while “target” means, “set as a
goal.” In claim 1 of the ’621 patent, “more effective” has its ordinary meaning.
SO ORDERED.

s/ Stanley R. Chesler
Stanley R. Chesler, U.S.D.J.

Dated: November 14, 2017

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