OTSUKA PHARMACEUTICAL CO., LTD. v. INTAS PHARMACEUTICALS LIMITED et al
Filing
155
MEMORANDUM OPINION re: Otsuka's unopposed Motions for the entry of Summary Judgments of Non-Infringement on their '350 Patent Cliams. Signed by Chief Judge Jerome B. Simandle on 3/30/2016. (TH, )
IN THE UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF NEW JERSEY
OTSUKA PHARMACEUTICAL CO., LTD.,
Plaintiff,
v.
INTAS PHARMACEUTICALS LIMITED, ACCORD
HEALTHCARE, INC., and HETERO LABS
LIMITED,
Defendants
OTSUKA PHARMACEUTICAL CO., LTD.,
Plaintiff,
v.
AUROBINDO PHARMA LIMITED, AUROBINDO
PHARMA USA, INC., and AUROLIFE PHARMA
LLC,
Defendants.
OTSUKA PHARMACEUTICAL CO., LTD.,
Plaintiff,
v.
ALEMBIC PHARMACEUTICALS LIMITED,
Defendant.
HONORABLE JEROME B. SIMANDLE
Civil Action Nos.
14-6158 (JBS/KMW)
14-6890 (JBS/KMW)
14-7405 (JBS/KMW)
MEMORANDUM OPINION REGARDING
OTSUKA’S UNOPPOSED MOTION FOR
THE ENTRY OF SUMMARY JUDGMENTS
OF NONINFRINGEMENT ON THEIR
’350 PATENT CLAIMS
SIMANDLE, Chief Judge:
These related patent infringement actions under the HatchWaxman Act, 35 U.S.C. §§ 271, 281, concern Plaintiff Otsuka
Pharmaceutical Co, Ltd.’s (hereinafter, “Otsuka”) position that
the abbreviated new drug applications (hereinafter, “ANDAs”) of
Intas Pharmaceuticals Limited, Accord Healthcare, Inc., Hetero
Labs Limited (hereinafter, the “Accord Defendants”), Aurobindo
Pharma Limited, Aurobindo Pharma USA, Inc., Aurolife Pharma LLC
(hereinafter, the “Aurobindo Defendants”), and Alembic
Pharmaceuticals Limited (hereinafter, the “Alembic Defendant”
and collectively, “the Standalone Defendants”) infringe the
method of use patent associated with Otsuka’s Abilify®
aripiprazole product, U.S. Patent No. 8,759,350 (hereinafter,
“the ’350 patent”).1
On November 16, 2015, this Court construed the phrase
“a/the pharmaceutical composition” / “in combination with,” as
it appears in asserted claims 1 through 18 of the ’350 patent,
to mean “a single dosage form, or ‘pharmaceutical composition,’
containing at least two active ingredients: aripiprazole and at
least one of citalopram, escitalopram and salt thereof.”
Otsuka
Pharm. Co. v. Torrent Pharm. Ltd., Inc., ___ F. Supp. 3d ____,
2015 WL 7195222, at *22 (D.N.J. Nov. 16, 2015) (hereinafter, the
“Markman decision”).
In view of this construction, and
Defendants’ representations concerning the single-ingredient
nature of their ANDA products, Otsuka seeks the entry of summary
judgment in favor of the Standalone Defendants on the ’350
patent infringement claims.2
[See Docket Item 136 in 14-6158;
1
The standalone nature of these related actions makes them
contextually different from the larger series of related cases
involving Otsuka, including separate actions involving these
Standalone Defendants, and not involving the ’350 patent. See,
e.g., Otsuka v. Accord, et al., No. 14-3996 (involving Otsuka’s
’615, ’796, and ’760 Patents); Otsuka v. Aurobindo, et al., No.
14-3306 (involving Otsuka’s ’615, ’796, and ’760 Patents); and
Otsuka v. Alembic, No. 14-2982 (involving Otsuka’s ’615, ’796,
and ’760 Patents).
2 Assuming the entry of summary judgments of noninfringement,
Otsuka then requests that Defendants’ counterclaims concerning
the ’350 patent be dismissed without prejudice. This Court
will, as explained below, enter summary judgments of
noninfringement on the ’350 patent. As a result, the Court will
dismiss Defendants’ counterclaims directed at the ’350 Patent
without prejudice to reinstatement in the event the Federal
2
Docket Item 114 in 14-6890; Docket Item 144 in 14-7405.]
The
Standalone Defendants acknowledge the propriety of summary
judgment on the ’350 patent claims, but seek to consolidate
their standalone ’350 patent cases with their related cases
involving Otsuka’s other aripiprazole Patents (in lieu of the
entry of summary judgments), in order to avoid the distraction
associated with Otsuka’s intended appeal of this Court’s Markman
decision.3
[See Docket Item 146 in 14-6158; Docket Item 124 in
14-6890; Docket Item 154 in 14-7405.]
For the brief reasons that follow, Otsuka’s motions for
summary judgment will be granted, and the Court will enter
judgments of noninfringement in favor of the Standalone
Defendants on the ’350 patent.
The Court finds as follows:
1.
Factual Background.
For purposes of the pending
motions, the Court need not retrace the lengthy factual and
Circuit Court of Appeals reverses or remands this case back to
this Court. See, e.g., Nystrom v. Trex Co., Inc., 339 F.3d
1347, 1351 (Fed. Cir. 2003) (citation omitted) (explaining the
discretion of district courts “to dismiss a counterclaim ... as
moot where [the court] finds no infringement”).
3 In light of the Standalone Defendants’ request for
consolidation, the Court afforded Otsuka an opportunity to voice
its position on the issue. [See Docket Item 147 in 14-6158;
Docket Item 125 in 14-6890; Docket Item 156 in 14-7405.]
Otsuka, in turn, filed a response objecting to the Standalone
Defendants’ “attempted use of consolidation for the purpose of
blocking Otsuka’s appeal.” [Docket item 148 in 14-6158; Docket
Item 126 in 14-6890; Docket Item 159 in 14-7405.]
3
procedural background of these related infringement actions.
Rather, it suffices to note that the Standalone Defendants have,
since inception of these actions, taken the position that their
proposed ANDA products cannot, as a matter of law, directly
infringe any claim of the ’350 patent, because their proposed
aripiprazole products contain only a single active ingredient,
aripiprazole, and not the multi-component pharmaceutical
composition (consisting of aripiprazole in addition to either
citalopram and/or escitalopram) disclosed by the ’350 patent.
[See, e.g., Docket Item 55 at 1 in 14-7405 (“Alembic’s proposed
generic product contains aripiprazole and only aripiprazole”).]
2.
In the Markman decision, this Court construed the
phrases “a/the pharmaceutical composition” and “in combination
with,” as they appear in all asserted claims of the ’350 patent,
to mean “a single dosage form, or ‘pharmaceutical composition,’
containing at least two active ingredients: aripiprazole and at
least one of citalopram, escitalopram and salt thereof.”
See
Otsuka Pharm. Co., ___ F. Supp. 3d ____, 2015 WL 7195222, at
*22.
In other words, for a drug product to infringe the
asserted claims of the ’350 patent, as construed, that product
must contain a single dosage form with two active pharmaceutical
ingredients, aripiprazole and either citalopram or escitalopram,
or salts thereof.
Against that backdrop, the Court turns first
to the Standalone Defendants’ request for consolidation, and
4
then addresses Otsuka’s principally unopposed position on
summary judgment.
3.
Standard of Review Applicable to the Standalone
Defendants’ Consolidation Request.
Under Federal Rule of Civil
Procedure 42(a),4 “district courts have ‘broad power’ to
consolidate cases that share ‘common question[s] of law or
fact.’”
A.S. ex rel. Miller v. SmithKline Beecham Corp., 769
F.3d 204, 212 (3d Cir. 2014) (quoting Ellerman Lines, Ltd. v.
Atl. & Gulf Stevedores, Inc., 339 F.2d 673, 675 (3d Cir. 1964),
cert. denied, 382 U.S. 812 (1965); citing United States v.
Schiff, 602 F.3d 152, 176 (3d Cir. 2010) (noting that a district
court has “broad discretion in its rulings concerning case
management”)).
The mere existence of common issues, however,
does not require consolidation.
See Liberty Lincoln Mercury,
Inc. v. Ford Marketing Corp., 149 F.R.D. 65, 80-81 (D.N.J. 1993)
(citations omitted).
Nor can practical or administrative
concerns serve, on their own, as a basis to consolidate.
See
ACR Energy Partners, LLC v. Polo N. Country Club, Inc., 309
F.R.D. 193, 194 (D.N.J. 2015) (citation omitted).
4
Federal Rule of Civil Procedure 42(a) specifically provides
that, “[i]f actions before the court involve a common question
of law or fact, the court may: (1) join for hearing or trial any
or all matters at issue in the actions; (2) consolidate the
actions; (3) or issue any other orders to avoid unnecessary cost
or delay.” FED. R. CIV. P. 42(a)(1)-(3).
5
4.
Discussion.
Here, although these related actions,
standalone or otherwise,5 arise from the Standalone Defendants’
ANDAs, and therefore share some common questions of law and/or
fact with their other pending actions, the Court finds that
consolidation would, at this time, be inappropriate.
Indeed,
given the parties’ essential agreement that no litigable issues
remain relative to the ’350 patent, consolidation would
primarily serve the impermissible purpose of impeding Otsuka’s
right to seek appellate review of this Court’s Markman decision
until after the other patent claims are resolved in the related
actions.6
For that reason, this Court declines to exercise its
discretion to consolidate these actions with the Standalone
Defendants’ other aripiprazole patent cases not involving the
’350 patent.
5.
Standard of Review Applicable to Otsuka’s Summary
Judgment Motion.
Under Federal Rule of Civil Procedure 56(a),
summary judgment is appropriate if “there is no genuine issue as
to any material fact and the moving party is entitled to
5
The related separate actions involving these same Standalone
Defendants but not containing claims based on the ’350 patent
are identified in note 1, supra.
6 The Court recognizes that an appeal will invariably distract
counsel, to some extent, from their active aripiprazole
litigation in this District. Nevertheless, the practical
difficulties of an appeal do not provide a basis for
consolidation, particularly where consolidation would, in
effect, delay Otsuka’s opportunity for appellate review.
6
judgment as a matter of law.”
Alabama v. North Carolina, 560
U.S. 330, 344 (2010) (citations and internal quotation marks
omitted); see also FED. R. CIV. P. 56(a).
In other words, where
“the record taken as a whole could not lead a rational trier of
fact to find for the non-moving party,” the Court may grant
summary judgment.
Matsushita Elec. Indus. Co., Ltd. v. Zenith
Radio Corp., 475 U.S. 574, 587 (1986).
6.
Discussion.
This Court’s Markman decision construed
the asserted claims of the ’350 Patent, as explained above, to
claim a product comprised of a single dosage form with two
active pharmaceutical ingredients, aripiprazole and either
citalopram or escitalopram, or salts thereof.
See Otsuka Pharm.
Co., ___ F. Supp. 3d ____, 2015 WL 7195222, at *22.
In these
cases, though, there is no genuine factual dispute that the
Standalone Defendants’ ANDA products contain only a single
active ingredient, aripiprazole, and not the two active
pharmaceutical ingredients required by the ’350 patent.
As a
result, there remains no triable issue on Otsuka’s claims of
infringement under the ’350 patent.
More specifically, the
Court finds the Standalone Defendants’ ANDA products
noninfringing, because they do not contain the two active
7
ingredients required by the ’350 patent, as construed in this
Court’s Markman decision.7
7.
For all of these reasons, Otsuka’s motions for summary
judgments of noninfringement will be granted.
Appropriate
judgments of noninfringement, largely in the form proposed by
Otsuka, will be entered in each action.
March 30, 2016
Date
s/ Jerome B. Simandle
JEROME B. SIMANDLE
Chief U.S. District Judge
7
The Court finds it noteworthy that stipulated judgments of
noninfringement have been entered in every related case
involving the ’350 patent (all of which concern generic
defendants that equally claim single-ingredient aripiprazole
products). [See, e.g., Docket Item 206 in 14-3168; Docket Item
143 in 14-4508; Docket Item 201 in 14-4671; Docket Item 155 in
14-5537; Docket Item 156 in 14-5876; Docket Item 209 in 14-5878;
Docket Item 208 in 14-6398; Docket Item 131 in 14-7105; Docket
Item 164 in 14-7252; Docket Item 225 in 14-8074; Docket Item 119
in 14-8077; Docket Item 116 in 15-1585; Docket Item 146 in 15161.]
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