OTSUKA PHARMACEUTICAL CO., LTD. v. APOTEX CORP. et al

Filing 164

MEMORANDUM OPINION. Signed by Chief Judge Jerome B. Simandle on 8/11/2015. (TH, )

IN THE UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF NEW JERSEY

OTSUKA PHARMACEUTICAL CO.,
LTD.,
Plaintiff,

HONORABLE JEROME B. SIMANDLE

Civil Action No.
14-8074 (JBS/KMW)

v.
APOTEX CORP., APOTEX INC. and
HETERO LABS LTD.,

MEMORANDUM OPINION

Defendants.
SIMANDLE, Chief Judge:
This patent infringement action, one of twenty-six related
actions under the Hatch-Waxman Act, 35 U.S.C. §§ 271, 281,
generally concerns Plaintiff Otsuka Pharmaceutical Co, Ltd.’s
(hereinafter, “Otsuka”) position that Apotex Corp.’s and Apotex
Inc.’s (collectively, “Apotex”) proposed generic aripiprazole
product infringes one or more claims of four of the various
patents covering Otsuka’s Abilify® aripiprazole product, U.S.
Patent Nos. 8,017,615 (“the ’615 patent”), 8,580,796 (“the ’796
patent”), 8,642,760 (“the ’760 patent”), and 8,759,350 (“the
’350 patent” and collectively, the “Patents-in-Suit”).
Otsuka now moves to dismiss Apotex’s Ninth and Tenth
Counterclaims for “Unlawful Monopolization” and for “Patent
Misuse” (hereinafter, the “Counterclaims”) pursuant to Federal
Rule of Civil Procedure 12(b)(6) or, in the alternative, to

bifurcate and stay Apotex’s Counterclaims pending resolution of
the primary patent infringement issues pursuant to Federal Rule
of Civil Procedure 42(b).

[Docket Item 102.]

The Court

recently addressed the viability of substantively identical, but
slightly less developed, counterclaims in Otsuka Pharmaceutical
Co., Ltd. v. Torrent Pharm. Ltd., Inc., ___ F. Supp. 3d ____,
No. 14-1078, 2015 WL 3869677 (D.N.J. June 22, 2015), and reaches
substantially the same result in connection with the pending
motion.1

For the reasons that follow, Otsuka’s motion will be

granted in part and denied in part.
1.

The Court finds as follows:

As this Court has summarized on numerous occasions,

Otsuka holds New Drug Application (hereinafter, “NDA”) No. 21436, approved by the Food and Drug Administration (hereinafter,
the “FDA”), for aripiprazole tablets, which Otsuka markets under
the trade name Abilify®.

(See Am. Compl. at ¶¶ 1, 18, 20.)

In

connection with Abilify®’s listing in the Orange Book, the FDA’s
book of drug products approved under the Food, Drug, and
Cosmetic Act (hereinafter, the “Orange Book”), 21 U.S.C. §
355(j), Otsuka identifies the Patents-in-Suit, and discloses
1

Following the Court’s decision in Torrent, Apotex sought leave
to file a sur-reply, in order to address the decision’s
potentially “dispositive” impact on the pending motion. [Docket
Item 142.] Because the Torrent decision directly impacts the
pending motion, the Court has considered Apotex’s sur-reply. On
the other hand, Otsuka’s reply brief, filed on June 29, 2015,
seven days after the Torrent Opinion of essentially the
identical issues in the related case, makes no mention of the
Torrent decision. (See Otsuka’s Reply.)
2 

Abilify®’s active ingredient as “aripiprazole,” the dosage form
as a “tablet” or “oral,” and the strengths as 2 mg, 5 mg, 10 mg,
15 mg, 20 mg, and 30 mg.
2.

(Countercl. at ¶¶ 32-34.)

In late 2014, Apotex filed Abbreviated New Drug

Application (hereinafter, “ANDA”) No. 78-583 with the FDA,
seeking approval to market generic 2 mg, 5 mg, 10 mg, 15 mg, 20
mg, and 30 mg aripiprazole tablets in the United States, prior
to expiration of the Patents-in-Suit.
37.)

(See Countercl. at ¶¶ 35-

Apotex’s ANDA filing included a “paragraph IV

certification” pursuant to 21 U.S.C. § 355(j)(2)(A)(vii)(IV), in
which Torrent set forth its assertion that the Abilify® patents
would not be infringed by the commercial manufacture, use, or
sale of Apotex’s generic aripiprazole product.
3.

(See id.)

On November 12, 2014, Apotex then mailed notice of its

ANDA certification to Otsuka, and provided a detailed
explanation of the bases for Apotex’s position that its generic
aripiprazole tablets would not infringe any valid or enforceable
claim of the Orange Book-listed Patents-in-Suit.

(Id. at ¶ 38.)

In order to substantiate its non-infringement and/or invalidity
positions, Apotex’s notice “included an Offer of Confidential
Access” to its ANDA and supporting materials.
4.

(Id.)

Despite Apotex’s assertions, Otsuka filed an initial

and Amended Complaint in this District, alleging that Apotex’s
proposed generic product “will, if approved and marketed,”
3 

infringe at least one claim of the Patents-in-Suit.
at ¶¶ 24, 34, 44, 54.)

(Am. Compl.

On March 23, 2015, Apotex responded to

Otsuka’s Amended Complaint and, as relevant here, asserted
Counterclaims for “Unlawful Monopolization in Violation of the
Sherman Act: Sham Litigation” and for a “Declaratory Judgment of
Unenforceability” of the Patents-in-Suit for “Patent Misuse.”
(Countercl. at ¶¶ 72-118.)
5.

Apotex’s “Unlawful Monopolization” Counterclaim

alleges, in particular, that Otsuka “has the power to control
prices and/or exclude competition in, or prevent entry into” the
aripiprazole market, and claims that Otsuka has wielded that
power “to monopolize” the market.

(Id. at ¶¶ 80-81.)

Indeed,

Apotex claims that Otsuka has “engaged” in a “predatory scheme
to monopolize” the aripiprazole market through its institution
of “objectively baseless and sham judicial proceedings designed
to continue its monopoly of aripiprazole tablets” and to prevent
Apotex, among other generic companies, from competing in the
aripiprazole market.

(Id. at ¶¶ 86-88, 106-108.)

Apotex

therefore alleges that this infringement litigation amounts to
“sham” and “bad faith” litigation, in violation of the Sherman
and Clayton Acts, 15 U.S.C. §§ 2, 15, and 26.

(Id. at ¶¶ 72-

110.)
6.

Apotex’s patent misuse Counterclaim largely reiterates

the allegations of its antitrust Counterclaim, and specifically
4 

alleges that Otsuka filed this action without “any good faith
factual or legal basis” to support its infringement positions,
and for purposes of delaying Apotex’s entry into the marketplace
for aripiprazole tablets.

(Id. at ¶¶ 111-14.)

Apotex further

alleges that Otsuka has, in filing and prosecuting this
“baseless” action, “impermissibly broadened the physical or
temporal scope” of the Patents-in-Suit and asserted the patents
in order “to obtain a market benefit beyond that which inheres
in the statutory patent right.”
7.

(Id. at ¶¶ 115-16.)

In moving to dismiss, Otsuka argues, as it did in

connection with substantially similar counterclaims in Torrent,
___ F. Supp. 3d ____, 2015 WL 3869677, that Apotex’s antitrust
and patent misuse Counterclaims must be dismissed, because
Apotex has not alleged the “anticompetitive” or “antitrust”
injury” required for antitrust standing, because Apotex’s
“cursory conclusions” fail to plausibly overcome Otsuka’s NoerrPennington immunity, and because Apotex’s patent misuse
counterclaim fails as a matter of law to state a cognizable
claim for patent misuse.
Reply at 1-5.)

(See Otsuka’s Br. at 5-11; Otsuka’s

In the alternative, Otsuka requests that the

Court follow the “‘standard practice’” of bifurcating for trial
the patent issues raised in this litigation from the antitrust
and/or patent misuse issues.

(Otsuka’s Br. at 12 (citations

omitted); Otsuka’s Reply at 6.)
5 

8.

Under Federal Rule of Civil Procedure 12(b)(6), the

court must generally accept as true the factual allegations of
the defendant’s counterclaims, and construe all “reasonable
inferences” in the light most favorable to the defendant.
Revell v. Port Auth. Of N.Y., N.J., 598 F.3d 128, 134 (3d Cir.
2010); see also Fleisher v. Standard Ins. Co., 679 F.3d 116, 120
(3d Cir. 2012) (same).

However, “[a] pleading that offers

labels and conclusions or a formulaic recitation of the elements
of a cause of action” fails to suffice.
U.S. 662, 678 (2009).

Ashcroft v. Iqbal, 556

Rather, the “well-pled factual

allegations” must be sufficient to demonstrate a plausible
“entitlement to relief.”

Iqbal, 556 U.S. at 678 (quoting Bell

Atl. Corp. v. Twombly, 550 U.S. 544, 570 (2007)); see also
Umland v. PLANCO Fin. Serv., Inc., 542 F.3d 59, 64 (3d Cir.
2008).
9.

As stated above, Otsuka moves to dismiss Apotex’s

antitrust Counterclaim for lack of standing and on immunity
grounds, and moves to dismiss Apotex’s patent misuse
Counterclaim for failure to state a plausible claim for relief.
For substantially the reasons stated in Torrent, the Court will
deny Otsuka’s motion to the extent it seeks the dismissal of
Apotex’s Counterclaims.

Nevertheless, the Court will briefly

address each issue in turn.

6 

10.

A party suing under federal antitrust laws, as here,

must meet the prudential requirement of “‘antitrust standing.’”2
Ethypharm S.A. France, 707 F.3d at 232 (citation omitted).

In

Ethypharm S.A. France, the Court of Appeals for the Third
Circuit outlined a five-factor test, with the second, “antitrust
injury,” constituting the essential precondition for antitrust
standing.

Id. (citation omitted).

In other words, in the

absence of a plausible allegation of antitrust injury, the only
factor presently challenged by Otsuka, the Court need not reach
the remaining factors.
11.

As stated by this Court in Torrent,

In order to plead an antitrust injury, the party must
allege facts showing (1) that it suffered an injury of
the type the antitrust laws seek to prevent, e.g.,
anticompetitive behavior, and (2) that the injury
resulted from the adversary’s unlawful or anticompetitive acts. See In re Niaspan Antitrust Litig.,
42 F. Supp. 3d 735, 753 (E.D. Pa. 2014) (quoting In re
K-Dur Antitrust Litig., 338 F. Supp. 2d 517, 534
(D.N.J. 2004)). The federal antitrust laws, however,
foster “‘the protection of competition not
competitors.’” Race Tires Am., Inc. v. Hoosier Racing
Tire Corp., 614 F.3d 57, 76-77 (3d Cir. 2010); see
also Brunswick Corp. v. Pueblo Bowl–O–Mat, Inc., 429
U.S. 477, 488 (1977) (citation omitted) (noting that
Congress enacted the antitrust laws “for ‘the
protection of competition, not competitors’”). As a
result, the pleaded facts must show “that ‘the
challenged action has had an actual adverse effect on
competition as a whole in the relevant market,’”
2

The Court’s decision in Torrent provides a detailed discussion
of the background of this “prudential requirement,” together
with an explanation of the differences between Article III
constitutional standing and antitrust standing. ___ F. Supp. 3d
____, 2015 WL 3869677, at *4.
7 

rather than just an adverse effect on the particular
competitor. Irish v. Ferguson, 970 F. Supp. 2d 317,
365 (M.D. Pa. 2013) (citations omitted); see also
Eichorn v. AT&T Corp., 248 F.3d 131, 140 (3d Cir.
2001) (noting that an antitrust injury does not lie
unless the allegedly anticompetitive conduct “has a
wider impact on the [overall] competitive market”).
Torrent, ___ F. Supp. 3d ____, 2015 WL 3869677, at *4 (footnote
omitted).
12.

The Court rejects, at the outset, Otsuka’s position

that Apotex cannot, under Ethypharm S.A. France, be considered a
competitor for purposes of antitrust standing, due to its lack
of FDA approval.

(See Otsuka’s Br. at 5-6.)

In Ethypharm S.A.

France, the Court of Appeals for the Third Circuit found the
plaintiff could not “be considered a competitor for purposes of
antitrust injury,” because “legal barriers particular to the
pharmaceutical market” precluded the plaintiff’s from marketing
a competing product. 707 F.3d at 236.

In so finding, however,

the Third Circuit relied upon the fact that the plaintiff acted
only as the foreign manufacturer of the product, and could not
“directly supply the United States market” with the disputed
drug.

Id.

Indeed, the plaintiff had specifically relinquished

its right to sell and distribute the product in the United
States through a third-party license agreement.

Id.

In other

words, the Third Circuit’s determination did not hinge upon the
status of the plaintiff’s FDA approval,3 and the legal barriers

3

Indeed, the Third Circuit expressly distinguished its decision
from the situation where, as here, the plaintiff has “filed a
8 

actually identified by, and relied upon, in Ethypharm S.A.
France are plainly absent here, because Otsuka’s own Amended
Complaint identifies Apotex’s intention to manufacture and
directly distribute/sell its proposed generic aripiprazole
product.
13.

(See Am. Compl. at ¶ 6.)
Moreover, if the Court accepted Otsuka’s position,

“antitrust standing under the Hatch–Waxman Act would be wholly
contingent on the vagaries of the timing of agency action.”
Bristol-Myers Squibb Co. v. Ben Venue Labs., 90 F. Supp. 2d 540,
545 (D.N.J. 2000).

This would, in turn, create an “anomalous”

result, because generic defendants have “little practical
incentive” to pursue final agency approval during the pendency
of infringement actions, and are often “better served” by
directing “their resources toward defense of the infringement
action.”

Id.

For these reasons, the Court holds that Apotex

has standing as a competitor for purposes of an antitrust injury
because it is an ANDA filer intending to manufacture and
directly distribute generic aripiprazole in the United States
market awaiting final FDA approval.

The Court next addresses

whether Apotex’s allegations prove otherwise sufficiently
plausible on the issue of antitrust injury.

Drug Master File with the FDA and ‘set forth other required
information for FDA approval’ of its drug.” 707 F.3d at 236 n.
20 (quoting Chemi SpA v. GlaxoSmithKline, 356 F. Supp. 2d 495,
497 (E.D. Pa. 2005)).
9 

14.

The “hallmark” for evaluating the plausibility of an

allegation of antitrust injury is whether “the actions alleged
to be anticompetitive when viewed ‘as a whole’ bear consequence
for the overall market, rather than only for an individual
competitor.”

Torrent, ___ F. Supp. 3d ____, 2015 WL 3869677, at

*5 (quoting TransWeb, LLC v. 3M Innovative Props. Co., No. 104413, 2011 WL 2181189, at *18 (D.N.J. June 1, 2011)).

Here,

Apotex’s antitrust Counterclaim alleges, in essence, that Otsuka
has initiated meritless infringement actions and subsequently
pursued preliminary injunctions against ANDA filers, in order
“to prevent any and all competitors from competing in the
marketplace” and to maintain its exclusive monopoly over the
aripiprazole market.

(Countercl. at ¶¶ 72-110.)

Apotex further

alleges that Otsuka’s “exclusionary, anticompetitive and
unlawful actions” have excluded “alternative source[s]” of
aripiprazole tablets and have, in particular, forestalled and
frustrated Apotex’s ability to compete in the aripiprazole
market.
15.

(Id. at ¶¶ 106-10.)
For largely the reasons stated in Torrent, Apotex’s

Counterclaim plausibly alleges the elements of an antitrust
injury, namely, “an injury of the type protected by the
antitrust laws, and that the injury derived, at least in part,
from anti-competitive acts.”
2015 WL 3869677, at *5-*6.

Torrent, ___ F. Supp. 3d ____,

Indeed, the pursuit of litigation
10 

that forestalls entry into the generic market and effectively
extends a long-standing monopoly, as alleged here, constitutes
precisely the type of “‘anti-competitive behavior’” that the
antitrust laws seek to redress.4

See id. (finding essentially

identical allegations sufficient).

For these reasons, the Court

finds that Apotex’s allegations, accepted as true, sufficiently
state an antitrust injury, and rejects Otsuka’s position that
Apotex’s antitrust Counterclaim should be dismissed for lack of
antitrust standing.5

Therefore, the Court turns to Otsuka’s

position that Noerr-Pennington immunity bars Apotex’s antitrust
Counterclaim.
16.

As stated by this Court in Torrent,

Under the Noerr-Pennington doctrine, a patent owner’s
initiation of patent infringement litigation receives
presumptive immunity from attack under the antitrust
laws. See generally Eastern R.R. Presidents
4

As in Torrent, the Court again notes that Otsuka has initiated
litigation against every ANDA filer. See Torrent, ___ F. Supp.
3d ____, 2015 WL 3869677, at *5 n.6 (noting Otsuka’s filings as
a matter of public record). Indeed, following Torrent, Otsuka
filed its twenty-sixth related infringement action against an
ANDA filer. See Otsuka Pharm. Co., Ltd. v. Macleods Pharms.
Ltd., Civil Action No. 15-5109 (JBS/KMW) (filed July 2, 2015).
5 Moreover, the existence of antitrust injury “involves complex
questions of fact,” ill-suited for resolution upon a motion to
dismiss. Schuylkill Energy Res., Inc. v. Pa. Power & Light Co.,
113 F.3d 405, 417 (3d Cir. 1997) (citing Brader v. Allegheny
Gen. Hosp., 64 F.3d 869, 876 (3d Cir. 1995) (collecting cases));
see also In re Niaspan Antitrust Litig., 42 F. Supp. 3d at 757
n.19 (collecting cases that have declined to resolve the
existence of antitrust injury through motions to dismiss). As a
result, even if Apotex’s allegations proved sparse, which they
do not, resolving the issue of antitrust injury exceeds the
scope of this limited Rule 12(b)(6) motion.
11 

Conference v. Noerr Motor Freight, 365 U.S. 127
(1961); United Mine Workers of Am. v. Pennington, 381
U.S. 657 (1965); see also Rochester Drug Co-op., Inc.,
712 F. Supp. 2d at 316 (considering Noerr-Pennington
immunity in the patent infringement context). Parties
who file “sham litigation” are, however, excepted from
the benefit of immunity under Noerr–Pennington.
Prof’l Real Estate Investors v. Columbia Pictures
Indus., Inc., 508 U.S. 49, 60–61 (1993). An allegation
of sham litigation consists of two elements: first,
“the lawsuit must be objectively baseless in the sense
that no reasonable litigant could realistically expect
success on the merits.” Id. (internal quotations and
citations omitted). Second, “the baseless lawsuit
[must] conceal[] an attempt to interfere directly with
the business relationships of a competitor,” rather
than reflect a legitimate effort to obtain judicial
review. Id.
Torrent, ___ F. Supp. 3d ____, 2015 WL 3869677, at *6.
17.

Here, Otsuka argues, as it did in Torrent, that Apotex

has failed to plead sufficient facts to trigger the sham
litigation exception to Otsuka’s presumptive Noerr-Pennington
immunity.

(See Otsuka’s Br. at 7-10; Otsuka’s Reply at 4-5.)

Nevertheless, the Court finds Apotex’s allegations even more
ample than those the Court deemed sufficient in Torrent, and
rejects Otsuka’s argument that Apotex’s Counterclaim should be
dismissed on immunity grounds.
18.

Critically, Apotex alleges that it provided Otsuka

with the “detailed legal and factual bases” for its position on
the non-infringement of Apotex’s ANDA product on November 12,
2014.

(Countercl. at ¶ 89.)

On December 23, 2014, Apotex then

provided Otsuka with supporting documentation of in excess of
13,000 pages, together with the raw materials and product
12 

samples associated with its ANDA product.

(Id. at ¶¶ 90-92.)

Despite this production, however, Otsuka filed this infringement
action on the following day, December 24, 2014.

(Id. at ¶ 93.)

Apotex therefore alleges that Otsuka filed this action without
regard for the contents of Apotex’s production, “despite a
complete lack of evidence of infringement,” and without any
other objective basis to buttress its claims of infringement.
(Id. at ¶¶ 93-96.)

Moreover, because Otsuka “initiated

litigation” despite the volume of Apotex’s evidence of alleged
noninfringement, Apotex submits that Otsuka filed this action
“in bad faith,” and “with the express purpose of achieving and
maintaining monopoly power,” and not in a legitimate effort to
obtain judicial review.
19.

(Id. at ¶¶ 97-110.)

These allegations, accepted as true for purposes of

this Rule 12(b)(6) motion, set forth plausible facts sufficient
to overcome Otsuka’s presumptive antitrust immunity under the
Noerr-Pennington doctrine.6

See Torrent, ___ F. Supp. 3d ____,

2015 WL 3869677, at *7 (finding essentially identical
allegations sufficient, and collecting supporting case law).
Moreover, even assuming the allegations proved insufficient,
6

The Court rejects Otsuka’s arguments concerning Apotex’s
Paragraph IV certification under 21 U.S.C. § 355(j)(2)(A)(vii),
Celgene Corp. v KV Pharm. Co., No. 07-4819, 2008 WL 2856469
(D.N.J. July 22, 2008), and AstraZeneca AB v. Mylan Labs., Inc.,
2010 WL 2079722, at *4 (S.D.N.Y. May 19, 2010) for the reasons
set forth in Torrent, ___ F. Supp. 3d ____, 2015 WL 3869677, at
*7 n.10.
13 

which they do not, the inquiry into Otsuka’s Noerr-Pennington
immunity requires a detailed consideration of fact-sensitive
issues, which cannot be resolved in the context of a motion to
dismiss, and prior to discovery.
20.

See id.

For all of these reasons, the Court rejects Otsuka’s

argument that Apotex’s Counterclaim should be dismissed on
Noerr-Pennington immunity.

If, however, Apotex fails to meet

its burden of proof as to “sham” litigation” upon litigation of
the patent infringement claims and upon discovery as to Apotex’s
Counterclaims, Otsuka may renew its claim of Noerr-Pennington
immunity.7

The Court next addresses whether Apotex states a

plausible Counterclaim for patent misuse.
21.

The “key inquiry under the patent misuse doctrine is

whether ... the patentee has “‘impermissibly broaden[ed] the
physical or temporal scope’ of the patent grant with an
anticompetitive effect.”8

Princo Corp. v. Int’l Trade Comm’n,

616 F.3d 1318, 1328 (Fed. Cir. 2010) (quoting Windsurfing Int’l,
Inc. v. AMF, Inc., 782 F.2d 995, 1001 (Fed. Cir. 1986)).
7

A

Moreover, even if Apotex ultimately overcomes Noerr-Pennington
immunity, Apotex must still establish a substantive antitrust
violation in order to succeed on its Counterclaim. See Organon
Inc. v. Mylan Pharm., Inc., 293 F. Supp. 2d 453, 461 (D.N.J.
2003) (citation omitted). Finally, if the counterclaim
allegation of “sham” litigation is itself without reasonable
basis, Otsuka may invoke the constraints on baseless pleadings
provided by Rule 11, Fed. R. Civ. P.
8 In Torrent, the Court provided a detailed discussion of the
origination of this doctrine. See Torrent, ___ F. Supp. 3d
____, 2015 WL 3869677, at *8-*9.
14 

plausible claim for patent misuse must, in turn, include an
allegation that the patentee has impermissibly attempted to
enlarge the scope of its patent monopoly.

See, e.g., Torrent,

___ F. Supp. 3d ____, 2015 WL 3869677, at *9; Micron Tech., Inc.
v. Rambus Inc., 917 F. Supp. 2d 300, 320 n.19 (D. Del. 2013);
Altana Pharma AG v. Teva Pharm. USA, Inc., No. 04-2355, 2012 WL
2068611 (D.N.J. June 7, 2012); Cordance Corp. v. Amazon.com,
Inc., 727 F. Supp. 2d 310, 333-34 (D. Del. July 23, 2010); In re
Gabapentin Patent Litig., 648 F. Supp. 2d 641, 652 (D.N.J.
2009).

As a result, in Torrent, the Court dismissed the patent

misuse counterclaim without prejudice, because the counterclaim
lacked the “essential allegation” of an “improper expansion of
the physical or temporal breadth of the disputed patents.”
Torrent, ___ F. Supp. 3d ____, 2015 WL 3869677, at *9.
22.

Apotex’s Counterclaim, by contrast, plainly alleges

that this action amounts to an impermissible attempt to prolong
the life of Otsuka’s long-standing monopoly in the aripiprazole
market.

(See generally Countercl. at ¶¶ 111-18.)

Indeed,

Apotex specifically alleges that Otsuka has wielded the Patentsin-Suit beyond their permissible “physical or temporal scope” in
order to obtain a market advantage.9

(Id. at ¶ 116.)

These

allegations, accepted as true for purposes of this Rule 12(b)(6)
9

For that reason, Apotex’s Counterclaim differs markedly from
the patent misuse Counterclaim this Court found insufficient in
Torrent. See ___ F. Supp. 3d ____, 2015 WL 3869677, at *9.
15 

motion, sufficiently state a claim of patent misuse.

Bayer AG

v. Housey Pharmaceuticals, Inc., 169 F. Supp. 2d 328, 331 (D.
Del. 2001) (finding similar allegations sufficient), aff’d, 340
F.3d 1367 (Fed. Cir. 2003).
23.
and stay.

The Court last addresses Otsuka’s request to bifurcate
Under Federal Rule of Civil Procedure 42(b), the

Court may “order a separate trial of one or more separate
issues, claims, crossclaims, counterclaims, or third-party
claims,” in order to encourage “convenience, to avoid prejudice,
or to expedite and economize.”

FED. R. CIV. P. 42(b).

In

determining whether to bifurcate, courts carefully balance
“considerations of convenience, avoidance of prejudice, and
efficiency,” and must ensure the preservation of the litigant’s
constitutional right to a jury.

Torrent, ___ F. Supp. 3d ____,

2015 WL 3869677, at *9 (citations and internal quotations
omitted).
24.

Considering the various factors presented in this

action, and the parties’ qualified agreement,10 the Court will

10

Apotex consents to Otsuka’s request to bifurcate and stay
Apotex’s Counterclaims, but attempts to condition this consent
upon Otsuka’s agreement that the parties proceed with fact
discovery relative to these Counterclaims. (See Apotex’s Surreply at 5.) It is well established that “antitrust discovery
can be [exceedingly] expensive.” Twombly, 550 U.S. at 558.
Bifurcation, in turn, aims to ensure efficiency and avoid
needless expense, particularly where resolution of the primary
claims may, as here, obviate the need to proceed to discovery on
the remaining claims. For these reasons, the Court will stay
16 

bifurcate and stay Apotex’s antitrust and patent misuse
Counterclaims.

Critically, resolution of the patent

infringement issues may moot these Counterclaims, thereby
preserving judicial economy.

Bifurcation of these Counterclaims

from the already-complex patent infringement claims further
enhances “the parties’ right to jury trial by making the issues
the jury must consider less complex.”

Warner Lambert Co. v.

Purepac Pharm. Co., Nos. 98-2749, 99-5948, 00-2053, 2000 WL
34213890, *11 (D.N.J. Dec. 22, 2000) (internal quotation marks
omitted).
25.

For these reasons, the Court will follow the practice

of separating for trial patent issues and antitrust issues.

See

In re Innotron Diagnostics, 800 F.2d 1077, 1084 (Fed. Cir. 1986)
(affirming the severance of patent and antitrust claims as in
the interests of judicial economy); see also Torrent, ___ F.
Supp. 3d ____, 2015 WL 3869677, at *9-*10 (bifurcating and
staying a substantively identical antitrust counterclaim);
Eurand Inc. v. Mylan Pharm. Inc., No. 08-889, 2009 WL 3172197,
at *2 (D. Del. Oct. 1, 2009) (granting motion to sever and stay
antitrust and patent misuse counterclaims and affirmative
defenses from the patent infringement action).

Apotex’s Counterclaims for all purposes (discovery or
otherwise), pending resolution of Otsuka’s patent infringement
claims.
17 

26.

For the reasons stated above, Otsuka’s motion will be

denied to the extent it seeks dismissal of Apotex’s antitrust
and patent misuse Counterclaims.

Torrent’s antitrust and patent

misuse Counterclaims will, however, be bifurcated and stayed,
pending resolution of the patent infringement issues.
27.

An accompanying Order will be entered.

August 11, 2015
Date

s/ Jerome B. Simandle
JEROME B. SIMANDLE
Chief U.S. District Judge

18