OTSUKA PHARMACEUTICAL CO., LTD. v. MYLAN INC. et al
Filing
67
OPINION. Signed by Chief Judge Jerome B. Simandle on 3/23/2015. (dmr)
IN THE UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF NEW JERSEY
OTSUKA PHARMACEUTICAL CO.,
LTD.,
Plaintiff,
HONORABLE JEROME B. SIMANDLE
Civil Action
No. 14-4508 (JBS/KMW)
v.
MYLAN INC., MYLAN
PHARMACEUTICALS INC., and
MYLAN LABORATORIES LIMITED,
OPINION
Defendants.
APPEARANCES:
Melissa A. Chuderewicz, Esq.
PEPPER HAMILTON LLP
301 Carnegie Center
Princeton, N.J. 08543
-andJames B. Monroe, Esq.
Paul W. Browning, Esq.
Denise Main, Esq.
FINNEGAN, HENDERSON, FARABOW, GARRETT & DUNNER, LLP
901 New York Avenue, N.W.
Washington, D.C. 20001-4413
Attorneys for Plaintiff
Arnold B. Calmann, Esq.
Jeffrey Soos, Esq.
Katherine A. Escanlar, Esq.
SAIBER LLC
One Gateway Center, 10th Floor
Newark, N.J. 07102
-andDeepro R. Mukerjee, Esq.
Lance A. Soderstrom, Esq.
James C. Grant, Esq.
Jonathan D. Parente, Esq.
ALSTON & BIRD LLP
90 Park Avenue
New York, N.Y. 10016
Attorneys for Defendant
SIMANDLE, Chief Judge:
Table of Contents
INTRODUCTION .............................................. 2
BACKGROUND ................................................ 5
STANDARD OF REVIEW ....................................... 10
DISCUSSION ............................................... 11
A. Federal Circuit Law Governs the Court’s Resolution of the
Jurisdictional Issue ........................................ 11
B.
Personal Jurisdiction, Generally ....................... 12
1. Whether Mylan is “at home” in New Jersey for Purposes of
General Jurisdiction after Daimler ........................ 14
2. Mylan Inc. and Mylan Pharma Consented to Personal
Jurisdiction in this District by Registering to do Business
in New Jersey ............................................. 23
3.
The Court Lacks Specific Jurisdiction over Mylan Labs . 33
CONCLUSION ............................................... 35
INTRODUCTION
This patent infringement action is one of twenty-four
related actions concerning various defendants’ submission of
abbreviated new drug applications (hereinafter, “ANDAs”) for
Food and Drug Administration (hereinafter, “FDA”) approval to
market generic versions of Plaintiff Otsuka Pharmaceutical Co.,
Ltd.’s (hereinafter, “Otsuka”) aripiprazole product known as
Abilify®.
Defendants Mylan Inc., Mylan Pharmaceuticals Inc.
(“Mylan Pharma”) and Mylan Laboratories Limited (“Mylan Labs”
2
and collectively, “Mylan”) move to dismiss Otsuka’s Complaint
for lack of personal jurisdiction.1
[Docket Item 15.]
Mylan Inc., “one of the world’s leading generic and
specialty companies,” and its subsidiaries, Mylan Pharma and
Mylan Labs, specifically argue that Mylan lacks any claimrelated or jurisdiction-conferring contacts to New Jersey.
(See, e.g., Mylan’s Reply at 1-10.)
Otsuka counters, however,
that Mylan’s substantial connections with this forum readily
enable this Court to exercise personal jurisdiction over each
Mylan entity.
(See, e.g., Otsuka’s Opp’n at 9-19.)
Otsuka, in
particular, argues that Mylan’s compliance with the State of New
Jersey’s foreign corporation licensing and registration statute
constitutes consent to this Court’s jurisdiction; that Mylan’s
future intent to market and distribute its generic products in
New Jersey suffices for purposes of specific jurisdiction; and
that Mylan’s compliance with licensing and/or registration
requirements, revenue generation, and related activities
otherwise constitute “continuous and systematic” contacts with
this forum for purposes of general jurisdiction.
(See, e.g.,
id.)2
1
Of the over 30 defendants involved in these related actions,
only the Mylan Defendants have challenged this Court’s personal
jurisdiction.
2 Otsuka filed a sur-reply together with an informal request for
leave [Docket Item 38], which Mylan opposes as improper under
the Local Civil Rules. [Docket Item 42.] Despite Mylan’s
objection, given the complexity of the jurisdictional issues
3
Mylan does not dispute that each of its entities complies
with the statutory registration requirements of the State of New
Jersey, that each of its entities holds a wholesale distribution
license in the State of New Jersey, nor that each of its
entities generate revenue attributable to sales in the State of
New Jersey.
(See Tighe Dec. at ¶¶ 8, 9, 11; Tighe Supplemental
Dec. at ¶ 2.)
Rather, Mylan disputes whether this quantum of
connections suffices for purposes of personal jurisdiction,
given the Supreme Court’s “sea-change” jurisdictional decision
in Daimler AG v. Bauman, 134 S. Ct. 746 (2014), and because
Mylan maintains no corporate offices, facilities, nor records in
this State.
(See, e.g., Mylan’s Br. at 5-11; Mylan’s Reply at
1-10.)
The primary issues before the Court are whether the record
demonstrates that the Mylan Defendants’ contacts with this forum
render them “at home” in the State of New Jersey; whether
Mylan’s registration to do business in New Jersey and
appointment of an in-state agent for service of process amount
to consent to this Court’s jurisdiction; and whether, in
submitting an ANDA for FDA approval, the Mylan Defendants
purposefully directed activities at this forum.
For the reasons that follow, the Court finds that this
Court may exercise general jurisdiction over Mylan Inc. and
involved in the pending motion, the Court will grant Otsuka’s
informal request, and will consider Otsuka’s sur-reply.
4
Mylan Pharma.
Because Mylan Labs, however, lacks sufficient
jurisdictional contacts with this forum, Mylan Labs will be
dismissed.
Mylan’s motion will, accordingly, be denied with
respect to Mylan Inc. and Mylan Pharma, but granted with respect
to Mylan Labs.
BACKGROUND
A. Otsuka and New Drug Application No. 21-436
Otsuka, a pharmaceutical company organized and existing
under the laws of Japan, holds New Drug Application
(hereinafter, “NDA”) No. 21-436, approved by the FDA, for
aripiprazole tablets, which Otsuka markets under the trademark
Abilify®.
(See Compl. at ¶¶ 1, 16-17.)
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 following patents: U.S. Patent
Nos. 8,017,615 (“the ’615 patent”), 8,580,796 (“the ’796
patent”), 8,642,760 (“the ’760 patent”), 7,053,092 (“the ’092
patent”) and 8,642,600 (“the ’600 patent”), all of which Otsuka
owns by virtue of assignment.
(See id. at ¶¶ 5, 13, 17, 27, 30,
37, 40, 47, 50, 57, and 60.)
B. Mylan Inc., Mylan Pharma, and Mylan Labs
5
As stated above, the pending motion concerns the
jurisdictional contacts of three Mylan entities: Mylan Inc. and
its two subsidiaries, Mylan Pharma and Mylan Labs.
Mylan Inc., a Pennsylvania corporation having a principal
place of business in Canonsburg, Pennsylvania, manufactures,
markets, imports, and sells generic and specialty pharmaceutical
products throughout the United States, including in New Jersey.
(See id. at ¶ 2, 7; Tighe Dec. at ¶¶ 2-3, 11.)
Indeed, Mylan
Inc. expressly identifies itself as “one of the world’s leading
generic and specialty pharmaceutical companies,” which “markets
more than 1,300 different products in around 140 different
countries and territories” (Tighe Dec. at ¶ 3), and “holds the
number one ranking in the U.S. generics prescription market in
terms of sales and the number two ranking in terms of
prescriptions dispensed.”
(Compl. at ¶ 7; see also Ex. A to
Otsuka’s Opp’n.)
In 2006, the State of New Jersey authorized Mylan Inc. to
“transact business” as a “foreign profit corporation” pursuant
to N.J.S.A. §§ 14A:13-4, 14-1, -2.
Opp’n.)
(See Ex. F to Otsuka’s
In connection with New Jersey’s authorization, Mylan
Inc. identified its registered office and designated an in-state
agent for service process of process.
(See Tighe Dec. at ¶ 8
(noting Mylan Inc.’s compliance with statutory registration
requirements); Ex. F to Otsuka’s Opp’n (identifying an agent in
6
West Trenton, New Jersey).)
In addition to being registered in
New Jersey, Mylan holds a wholesale distribution license, and
generates annual revenues in excess of $100 million in this
State.
(See Tighe Dec. at ¶ 11.)
Finally, Mylan Inc. has
actively litigated, as both plaintiff and defendant, over 30
cases in this District. (See Ex. K to Otsuka’s Opp’n
(summarizing the cases).)
Nevertheless, Mylan Inc. maintains no
permanent, physical presence in the State of New Jersey.
Mylan Inc.’s subsidiary, Mylan Pharma serves as Mylan
Inc.’s “primary U.S. pharmaceutical research, development,
manufacturing, marketing and distribution subsidiary.”
(Tighe
Dec. at ¶ 4; Ex. A to Otsuka’s Opp’n; Compl. at ¶ 8.)
Like its
corporate parent, however, Mylan Pharma “does not have any
manufacturing plants, corporate offices, facilities, or other
real property in New Jersey.”
(Tighe Dec. at ¶ 6.)
Rather,
Mylan Pharma exists and operates in the State of West Virginia.
(See generally id.)
Nevertheless, Mylan Pharma has registered
to do business in New Jersey and has appointed an in-state agent
for service of process. (See Ex. G to Otsuka’s Opp’n.)
In
addition, Mylan Pharma holds a wholesale distribution license in
New Jersey, and generates annual revenues in excess of $50
million in this State.
(Tighe Dec. at ¶¶ 9, 11; Tighe
Supplementary Dec. at ¶ 2.)
Finally, Mylan Pharma has been an
equally active litigant in this District, having litigated over
7
30 cases, as both plaintiff and defendant. (See Ex. K to
Otsuka’s Opp’n (summarizing the cases).)
Mylan Labs, Mylan Inc.’s Indian subsidiary, constitutes
“‘one of the world’s largest manufacturers of active
pharmaceutical ingredients (APIs)’” (Compl. at ¶ 9 (citation
omitted)), and manufactures and supplies “low cost, high qualify
API for [Mylan Inc.’s] own products and pipeline.”
Otsuka’s Opp’n.)
(Ex. A to
Unlike its parent and sister corporations,
however, Mylan Labs has not registered as a foreign corporation
in New Jersey, nor appointed an agent for service of process.
(See Tighe Dec. at ¶ 8.)
Mylan Labs does, however, hold a
wholesale distribution license in New Jersey, generates revenues
“attributable to sales in New Jersey,” and has been involved in
at least three cases in this District.
(Id. at ¶ 11; see also
Ex. K to Otsuka’s Opp’n (summarizing the cases).)
C. Mylan Pharma’s ANDA Filing and ADNA Notice Letter
On November 16, 2013, Mylan Pharma submitted ANDA No. 206240 to the FDA in Maryland, seeking approval to market generic
aripiprazole tablets in the United States.
(Compl. at ¶ 19.)
Mylan Pharma’s ANDA filing included a “paragraph IV
certification” pursuant to 21 U.S.C. § 355(j)(2)(A)(vii)(IV), in
which Mylan Pharma set forth its assertion concerning the
Abilify® patents’ invalidity, in addition to its assertion that
the Abilify® patents will not be infringed by the commercial
8
manufacture, use, or sale of Mylan’s generic product.
(See
Tighe Dec. at ¶ 12.)
On May 28, 2014, Mylan Pharma then mailed notice, under 21
U.S.C. § 355(j)(2)(B)(ii), of its ANDA filing and its
certification of non-infringement and/or invalidity to Otsuka
Pharmaceutical Co., Ltd. in Japan and Otsuka America
Pharmaceutical, Inc. in Maryland.
(See Tighe Dec. at ¶ 12; see
also Compl. at ¶¶ 19-21, 31, 41, 51, and 61.)
D. Otsuka’s ANDA Litigation
As a result of Mylan Pharma’s ANDA filing, Otsuka filed a
Complaint in this District on July 11, 2014,3 alleging that Mylan
Pharma’s proposed generic product “will, if approved and
marketed,” infringe at least one claim of the ’615, ’796, ’760,
’092, and ’600 Patents.4
and 62-63.)
(Id. at ¶¶ 22-23, 32-33, 42-43, 52-53,
(See generally Compl. at ¶ 5.)
3
After Otsuka
At that time, Otsuka had filed six substantively identical
Complaints naming other ANDA filers as defendants. See, e.g.,
Otsuka Pharma. Co., Ltd. v. Torrent Pharma. Ltd., Inc., Civil
Act. No. 14-1078 (JBS/KMW); Otsuka Pharma. Co., Ltd. v. Alembic
Pharma. Ltd., Civil Act. No. 14-2982 (JBS/KMW); Otsuka Pharma.
Co., Ltd. v. Zydus Pharma. USA, Inc., Civil Act. No. 14-3168
(JBS/KMW); Otsuka Pharma. Co., Ltd. v. Aurobindo Pharma. Ltd.,
Civil Act. No. 14-3306 (JBS/KMW); Otsuka Pharma. Co., Ltd. v.
Intas Pharma. Ltd., Civil Act. No. 14-3996 (JBS/KMW); Otsuka
Pharma. Co., Ltd. v. Sun Pharma. Indus. Ltd., Inc., Civil Act.
No. 14-4307 (JBS/KMW).
4 On March 20, 2015, Otsuka moved to amend its Complaint in order
to alleged infringement of a sixth patent, U.S. Patent No.
8,759,350. [Docket Item 62.] Otsuka’s motion to amend will be
addressed by separate Order.
9
successfully effectuated service on October 1, 2014 [Docket
Items 7 and 8], the pending motion followed.
STANDARD OF REVIEW
Federal Rule of Civil Procedure 12(b)(2) permits a party to
move to dismiss a case for lack of personal jurisdiction.
FED. R. CIV. P. 12(b)(2).
See
Where, as here, the Court resolves the
jurisdictional issue in the absence of an evidentiary hearing
and without the benefit of discovery, the plaintiff need only
establish a prima facie case of personal jurisdiction. See
Avocent Huntsville Corp. v. Aten Int’l Co., Ltd., 552 F.3d 1324,
1328-29 (Fed. Cir. 2008) (citations omitted).
Therefore, the
Court must “accept the uncontroverted allegations in the
plaintiff’s complaint as true and resolve any factual conflicts
in the affidavits [and other written materials] in the
plaintiff’s favor.”
Elecs. for Imaging, Inc. v. Coyle, 340 F.3d
1344, 1349 (Fed. Cir. 2003) (citations omitted).
Nevertheless,
“the plaintiff bears the burden of showing the basis for
jurisdiction,” Graphic Props. Holdings, Inc. v. ASUS Computer
Int’l, ___ F. Supp. 3d ____, No. 13-864, 2014 WL 4949589, at *2
(D. Del. Sept. 29, 2014), and must establish “with reasonable
particularity sufficient contacts between the defendant and the
forum state.”
Mellon Bank (E) PSFS, Nat’l Ass’n v. Farino, 960
F.2d 1217, 1223 (3d Cir. 1992); see also AFTG-LG, LLC v Nuvoton
10
Tech. Corp., 689 F.3d 1358, 1360-61 (Fed. Cir. 2012) (discussing
the plaintiff’s prima facie burden).5
DISCUSSION
A. Federal Circuit Law Governs the Court’s Resolution of the
Jurisdictional Issue
The parties dispute the choice of law applicable to the
pending motion.
Mylan, in particular, insists that Federal
Circuit law governs the Court’s disposition of the
jurisdictional issue presented in the pending motion, while
Otsuka suggests that the Court must follow binding precedent of
the Third Circuit. (Compare Mylan’s Reply at 8 n.5, with
Otsuka’s Sur-reply at 1.)
The Court, however, does not find determination of the
relevant choice of law to be a particularly complex inquiry.
Indeed, because the pending jurisdictional issue arises in the
context of a patent infringement action under the Hatch-Waxman
Act, Federal Circuit law unquestionably governs the key disputed
issue, namely, whether due process would be offended in the
event the Court exercised personal jurisdictional over the Mylan
Defendants, the “out-of-state accused infringer[s].”
Nuance
Commc’ns, Inc. v. Abbyy Software House, 626 F.3d 1222, 1230
5
Moreover, the Court may always revisit the issue of personal
jurisdiction if later revelations reveal that the facts alleged
in support of jurisdiction remain in dispute. See Metcalfe v.
Renaissance Marine, Inc., 566 F.3d 324, 331 (3d Cir. 2009)
(citing Carteret Sav. Bank, FA v. Shushan, 954 F.2d 141, 142 n.1
(3d Cir. 1992)).
11
(Fed. Cir. 2010); see also Hildebrand v. Steck Mfg. Co., Inc.,
279 F.3d 1351, 1354 (Fed. Cir. 2002) (“We apply Federal Circuit
law to determine whether the district court properly exercised
personal jurisdiction over out-of-state defendants in patent
infringement cases.”); Acorda Therapeutics, Inc. v. Mylan
Pharma., Inc., ___ F. Supp. 3d ____, No. 14-935, 2015 WL 186833,
at *4 (D. Del. Jan. 14, 2015) (applying Federal Circuit law).6
Having determined the choice of law applicable to the pending
motion, the Court turns to personal jurisdiction under the
Federal Circuit’s standard
B. Personal Jurisdiction, Generally
A federal district court may assert personal jurisdiction
over a nonresident of the state in which the court sits to the
extent authorized by the law of that state.
See, e.g., Merial
Ltd. v. Cipla Ltd., 681 F.3d 1283, 1293-94 (Fed Cir. 2012).
Therefore, under Federal Circuit law, determining “whether
jurisdiction exists over an out-of-state defendant involves two
inquiries: whether a forum state’s long-arm statute permits
service of process and whether assertion of personal
6
Nevertheless, in the absence of relevant Federal Circuit
authority, particularly whether registration constitutes consent
for jurisdictional purposes, the Court may, and necessarily
must, refer to decisions of other federal courts for guidance.
See Acorda Therapeutics, Inc., 2015 WL 186833, at *9
(considering decisions of other court of appeals, given the
absence of Federal Circuit law); Forest Labs., Inc. v. Amneal
Pharma. LLC, No. 14-508, 2015 WL 880599, *9 n.10 (D. Del. Feb
26, 2015) (same).
12
jurisdiction violates due process.”
See Autogenomics, Inc. v.
Oxford Gene Tech. Ltd., 566 F.3d 1012, 1016 (Fed. Cir. 2009).
In this instance, however, because the New Jersey long-arm
statute “permits the exercise of personal jurisdiction to the
fullest limits of due process,” IMO Indus., Inc. v. Kiekert AG,
155 F.3d 254, 259 (3d Cir. 1998), “‘the two inquiries collapse’”
into one: whether the exercise of jurisdiction comports with due
process.
Autogenomics, Inc., 566 F.3d at 1017 (citations
omitted).
Accordingly, a court must consider whether the
“defendant has certain minimum contact with [the State] such
that the maintenance of the suit does not offend ‘traditional
notions of fair play and substantial justice.’” Daimler, 134 S.
Ct. at 754 (2014) (quoting Goodyear Dunlop Tires Operations,
S.A. v. Brown, 131 S. Ct. 2846, 2853 (2011)).
Sufficient jurisdictional contacts, in turn, arise in two
forms: general and specific.
Daimler, 134 S. Ct. at 754.
General jurisdiction, on one hand, generally requires that the
defendant’s contacts be “so ‘continuous and systematic’ as to
render them essentially at home in the forum State.’”
Id.
Specific jurisdiction, on the other hand, requires that the suit
“‘arise out of or relate to the defendant’s [specific] contacts
with the forum.’”
Id. (quoting Helicopteros Nacionales de
Colombia, S.A. v. Hall, 466 U.S. 408, 414 n.8 (1984)).
13
Otsuka asserts three ground for this Court’s exercise of
personal jurisdiction over the Mylan Defendants: (1) general
jurisdiction, notwithstanding Daimler; (2) general jurisdiction
based upon consent; and (3) specific jurisdiction.
The Court
will address each argument in turn.
1. Whether Mylan is “at home” in New Jersey for
Purposes of General Jurisdiction after Daimler
Otsuka first claims that the Mylan Defendants numerous
contacts with this forum suffice to subject each Mylan Defendant
to the general personal jurisdiction of this Court.
Otsuka’s Opp’n at 18-20.)
(See, e.g.,
The Mylan Defendants, however, claim
that their contacts plainly fail to render them “‘essentially at
home’” in this forum.
(Mylan’s Br. at 3-5.)
Indeed, Mylan
argues that its activities in this forum amount to little more
than the sort of activities the Supreme Court deemed
insufficient in Daimler.
(Id. at 3-6.)
Here, for the reasons
that follow, the Court determines that Daimler fundamentally
altered the general jurisdiction analysis, but need not reach
the ultimate issue of whether the Mylan Defendants’
jurisdictional contacts render them “at home” in this forum.
Prior to Daimler, general, all-purpose jurisdiction had
long been construed to require only that the defendant have
“‘continuous and systematic general business contacts’” with the
forum state.
AFTG-TG, LLC v. Nuvoton Tech. Corp., 689 F3d 1358,
1360 (Fed. Cir. 2012) (quoting LSI Indus. Inc. v. Hubbell
14
Lighting, Inc., 232 F.3d 1369, 1375 (Fed. Cir. 2000) (quoting
Burger King Corp., 471 U.S. at 472-73; Helicopteros Nacionales
de Colombia, S.A., 466 U.S. at 414-16)).
As a result, pre-
Daimler courts routinely found the exercise of general
jurisdiction appropriate based upon a foreign corporation’s
substantial, continuous, and systematic course of business
within a particular forum.
See, e.g., LSI Indus., Inc. v.
Hubbell Lighting, Inc., 232 F.3d 1369, 1374 (Fed. Cir. 2000).
Indeed, in ANDA litigation, as here, general jurisdiction
traditionally provided the basis to assert jurisdiction over
generic drug company defendants.
See, e.g., In re
Cyclobenzaprine Hydrochloride Extended–Release Capsule Patent
Litig., 693 F. Supp. 2d 409, 421 (D. Del. 2010) (focusing on
defendant's “substantial revenue” from Delaware drug sales in
upholding general jurisdiction).
In Daimler, however, the Supreme Court rejected as
“unacceptably grasping” an approach to finding general
jurisdiction wherein a corporation merely “engages in a
substantial, continuous, and systematic course of business” in
the forum state, thereby substantially curtailing the
application of general jurisdiction over corporate defendants.
See Daimler, 134 S. Ct. at 758-62.
Specifically, in Daimler, 22 Argentinian residents filed a
complaint in the Northern District of California against a
15
German manufacturer of luxury vehicles, DaimlerChrysler
Aktiengesellscaft (hereinafter, “Daimler”), alleging that
Daimler’s Argentinian subsidiary collaborated with Argentinian
security forces to commit human rights violations during
Argentina’s “‘Dirty War.’”
Daimler, 134 S. Ct. at 751-52.
Although the plaintiffs acknowledged that Daimler had no
ostensible involvement in the Argentina-based allegations, the
plaintiffs nevertheless alleged that Daimler should be held
“vicariously liable” for its Argentinian subsidiary’s “alleged
malfeasance.”
Id.
In filing the suit in California, the plaintiffs further
insisted that California courts could exercise jurisdiction over
Daimler for “any and all claims,” in light Daimler’s agency
relationship with its “indirect subsidiary,” Mercedes–Benz USA,
LLC (hereinafter, “MBUSA”).
Id. at 752.
MBUSA, Daimler’s
exclusive importer and distributor in the United States, existed
under the laws of Delaware and had its principal place of
business in New Jersey.
See id. at 751–52.
Nevertheless,
MBUSA’s annual sales of Daimler vehicles in California generated
approximately $4.6 billion in revenues—2.4% of Daimler’s global
sales—and MBUSA maintained several corporate facilities in the
state.
See id. at 751-52, 758; see also id. at 766-67
(Sotomayor, J., concurring).
16
Daimler’s own contacts with California, by contrast,
remained “sporadic.”
Id. at 758.
Despite the limited nature of
Daimler’s contacts, the plaintiffs argued that MBUSA’s
California contacts could be attributed to Daimler, MBUSA’s
alleged principal, for jurisdictional purposes. See id. at 751–
52.
Daimler moved to dismiss for want of personal jurisdiction,
and the District Court dismissed the plaintiffs’ complaint,
finding that MBUSA did not qualify as Daimler’s agent and that
Daimler’s own contacts failed to support an exercise of general
jurisdiction over Daimler in California.
See id. at 752.
The
Court of Appeals for the Ninth Circuit, however, ultimately
reversed on rehearing, finding that Daimler “purposefully and
extensively interjected itself into the California market
through MBUSA.”
Bauman v. DaimlerChrysler Corp., 644 F.3d 909,
925 (9th Cir. 2011).
The Supreme Court thereafter granted certiorari on the
issue of whether, consistent with due process, Daimler could be
held “amenable to suit in California for claims involving only
foreign plaintiffs and conduct occurring entirely abroad.”
at 753.
Id.
In a unanimous holding, the Supreme Court reversed the
Ninth Circuit.7
See id. at 758-62.
As relevant here, the
Supreme Court concluded that “Daimler’s slim contacts” with
7
Justice Sotomayor filed a concurrence, agreeing with the
Supreme Court’s ultimate judgment, but for different reasons.
Daimler, 134 S. Ct. at 763-773.
17
California “hardly” rendered it at home in the forum, even if
the Court assumed that MBUSA’s contacts could be “imputable to
Daimler.”
Id. at 760.
In so concluding, the Daimler Court clarified, in the
context of a suit in California for claims involving only
foreign plaintiffs and conduct occurring only abroad, that the
applicable inquiry for purposes of general jurisdiction “is not
whether a foreign corporation’s in-forum contacts can,” in some
sense, be considered “‘continuous and systematic.”
(citation omitted).
Id. at 761
Rather, the operative inquiry is “whether
that corporation's ‘affiliations with the State are so
“continuous and systematic” as to render [it] essentially at
home in the forum state.’” Id. at 761 (quoting Goodyear, 131 S.
Ct. at 2851) (alteration in original).
As a result, the Supreme
Court explained that a defendant’s “place of incorporation and
principal place of business” constitute the paradigm, and
seemingly exclusive, bases for finding a corporate defendant “at
home.” Id. at 760.
The Supreme Court found that the simplicity
of restricting general jurisdiction to these affiliations
promoted predictability, by allowing corporations “to structure
their primary conduct with some minimum assurance as to where
that conduct will and will not render them liable to suit,” all
while affording “plaintiffs recourse to at least one clear and
18
certain forum in which a corporate defendant may be sued on any
and all claims.”8
Id. at 760–62.
Nevertheless, the Daimler Court left open the possibility
that, in an “exceptional” case, “a corporation’s operations in a
forum other than its formal place of incorporation or principal
place of business may be so substantial and of such a nature as
to render the corporation at home in that State.”
n.19.
Id. at 761
An evaluation of the substantiality of a foreign
corporation’s operations under such circumstances, however,
“calls for an appraisal of a corporation’s activities in their
entirety, nationwide and worldwide,” because a corporation
simply operating in multiple forums could “scarcely be deemed at
home in all of them.”
Id. at 762 n.20.
With respect to
Daimler, however, the Court found its “activities in California
plainly” insufficient to approach that level, because California
did not serve as Daimler’s or MBUSA’s state of incorporation or
their principal place of business.
Id.
Nor could Daimler
reasonably have expected that it would be hailed into California
court on an “Argentina-rooted case.”
Id. at 761.
In relying upon Daimler, Mylan overstates its square
application to the nuanced jurisdictional issue presented in the
pending motion.
Indeed, the factual and legal contexts of this
8
By contrast, the Supreme Court suggested that “exorbitant”
theories of general jurisdiction would spawn “unpredictability,”
by rendering a corporation potentially liable to suit for all
claims in many if not all states. Id. at 761–62.
19
litigation could hardly be more different than those addressed
in Daimler.
Most fundamentally, the Daimler case involved
foreign plaintiffs from Argentina suing a foreign defendant from
Germany based upon conduct that occurred entirely in Argentina.
Given these circumstances, the Supreme Court readily concluded
that Daimler could “scarcely” have predicted that it would be
subjected to the general jurisdiction of California.
See, e.g.,
id. at 761–62 (describing Daimler as an “Argentina-rooted case,”
involving “claims by foreign plaintiffs having nothing to do
with anything that occurred or had its principal impact in
California”).
Here, by contrast, each Mylan Defendant has
specific, undisputed contacts with this forum and an intention
to market generic aripiprazole throughout the United States,
including in this forum; and, at the time Mylan provided Otsuka
with notice of its ANDA submission, Mylan had already filed
related Abilify® ANDA litigation in this District.
In that
regard, this litigation concerns primarily domestic corporations
and their domestic patent dispute, including Mylan’s ANDA
application to market a generic version of Otsuka’s Abilify®,
a factual predicate far more related to domestic and forum
interests and activities than that addressed by the Supreme
Court in Daimler.
Nevertheless, the Court cannot ignore that in Daimler the
Supreme Court expressed itself in broad language, and that the
20
factual circumstances of this litigation satisfy neither of the
paradigmatic scenarios for “at home” general jurisdiction under
Daimler.
Indeed, none of the Mylan Defendants constitute New
Jersey corporations, nor does New Jersey serve as their
principal place of business.
Moreover, although Daimler left
open “the possibility” that a foreign corporation’s operations
may, in an exceptional case, be of a sufficient nature “to
render the corporation at home in that State” id. at 761 n.19,
the record in this instance remains unclear as to whether the
Mylan Defendant’s contacts rise to a sufficiently substantial
level.
Critically, in arguing that the Mylan Defendants are “at
home” in New Jersey, Otsuka principally relies upon the Mylan
Defendants’ fractional revenue generation in New Jersey,
“frequent” litigation in this District, in addition to the
physical presence of various Mylan subsidiaries in this State.
(See, e.g., Otsuka’s Sur-reply at.)
These contacts, however, do
not appear the functional equivalent of incorporation or
principal place of business, nor do they unequivocally
demonstrate the requisite operations of the Mylan Defendants
within this State.
See, e.g., In re Asbestos Prods. Liability
Litig. (No. VI), 2014 WL 5394310, at *3 (E.D. Pa. Oct. 23, 2014)
(noting that “an ‘exceptional case’ authorizing general
jurisdiction is one in which the defendant's forum contacts are
21
so pervasive that they may substitute for its place of
incorporation or principal place of business”) (citing
Monkton
Ins. Servs., Ltd. v. Ritter, 13–50941, ___ F.3d ____, 2014 WL
4799716, at *2 (5th Cir. Sept. 26, 2014) (finding that it is
“incredibly difficult to establish general jurisdiction in a
forum other than the place of incorporation or principal place
of business”)).
Nevertheless, because the Court finds, as stated below,
that Mylan Inc. and Mylan Pharma consented to this Court’s
jurisdiction, the Court need not determine whether this
litigation constitutes an “exceptional case” in which any one of
the Mylan Defendants should be deemed “at home” in New Jersey.
But see Eli Lilly & Co. v. Mylan Pharmaceuticals, Inc., Civil
Action No. 14-389 (S.D. Ind. March 12, 2015) (finding Mylan not
“‘at home’” in Indiana); Acorda Therapeutics, Inc., ___ F. Supp.
3d ____, 2015 WL 186833, at *7 (finding Mylan not “‘at home’ in
Delaware” under Daimler, based upon nearly-identical
allegations); AstraZeneca, ___ F. Supp. 3d ____, 2014 WL
5778016, at *3 (same); AstraZeneca AB v. Mylan Pharma., Inc.,
No. 14-696, 2014 WL 5780213, at *3-*4 (D. Del. Nov. 5, 2014)
(same).9
Therefore, the Court turns to the parties’ positions
concerning consent-by-registration.
9
On December 17, 2014, Judge Gregory M. Sleet certified an
interlocutory appeal of the post-Daimler personal jurisdiction
issue in the context of the AstraZeneca ANDA litigation, and the
22
2. Mylan Inc. and Mylan Pharma Consented to Personal
Jurisdiction in this District by Registering to do
Business in New Jersey
Otsuka alternatively argues that the Court may exercise
general jurisdiction over Mylan Inc. and Mylan Pharma, given
their registration to do business in New Jersey, and appointment
of a registered agent for service of process in New Jersey.10
Federal Circuit recently granted interlocutory review. See
AstraZeneca AB v. Mylan Pharmaceuticals Inc., App. No. 2015-117
(Fed. Cir. Mar. 17, 2015). On January 14, 2015, Chief Judge
Leonard P. Stark then “wholeheartedly agree[d] with Judge Sleet
that the existence of personal jurisdiction in an ANDA case in a
post-Daimler world is an important question of first impression
that will be (and has been) raised in many pending ANDA cases,”
thereby requiring additional direction from the appellate
courts. Acorda Therapeutics, Inc., 2015 WL 186833. This Court
joins those District Courts in concluding that this complicated,
post-Daimler question of personal jurisdiction calls out for
clarification, particularly because the literal application of
Daimler in ANDA litigation may enable generic defendants with
sizable revenues in a forum to avoid the forum’s personal
jurisdiction, and may invite piecemeal litigation of large,
related ANDA cases. The present constellation of 24 cases
testing the remaining Otsuka patents with regard to defendants’
ANDA applications is most instructive. If all ANDA applicants
having both their principal place of business and their place of
incorporation outside New Jersey were dismissed for lack of
personal jurisdiction, the alternative would become numerous
duplicative ANDA suits in a dozen or more other courts about the
same patents and pharmaceuticals, multiplying the complexity and
uncertainty.
10 At the outset, the Court rejects Otsuka’s position that the
Mylan Defendants prior litigation activity, and “admission” of
personal jurisdiction, constitutes “consent” for purposes of
this action. (See, e.g., Otsuka’s Opp’n at 12.) In that
regard, the Court agrees with the Mylan Defendants that,
“‘consent to jurisdiction in one case ... extends to that case
alone.’” (Mylan’s Reply at 4 (quoting Klinghoffer v. S.N.C.
Achille Lauro Ed Altri-Gestione Motonave Achille Lauro in
Amministrazione Straordinaria, 937 F.2d 44, 50 (2d Cir. 1991));
see also Mallinckrodt Med., Inc. v. Sonus Pharms., 989 F. Supp.
265, 271 (D.D.C. 1998). Nevertheless, Mylan’s prior litigation
23
(Otsuka’s Opp’n at 13-14.)
The Mylan Defendants, however,
challenge the viable of a consent-by-registration theory of
personal jurisdiction on two principal grounds.
Reply at 6-9.)
(See Mylan’s
Mylan first insists that “the consent-by-
registration theory for general jurisdiction cannot survive in a
post-International Shoe Co. v Washington world.”
(Id. at 6-7.)
Mylan then relatedly claims that any “consent-by-registration
argument cannot be squared” with Daimler.
(Id. at 8.)
The Court, however, need not belabor Mylan’s arguments,
because it cannot be genuinely disputed that consent, whether by
registration or otherwise, remains a valid basis for personal
jurisdiction following International Shoe and Daimler.
Indeed,
International Shoe itself clearly reflects that the Supreme
Court’s jurisdictional determinations related to cases where “no
consent to be sued or authorization to an agent to accept
service of process has been given.” See Int'l Shoe Co., 326 U.S.
at 317.
Moreover, the Supreme Court has specifically concluded,
on two separate occasions, that a corporation’s appointment of
an agent for service of process constitutes, under certain
infers, as stated below, some level of contact, even if
insufficient for “at home” purposes, with this District. More
importantly, current cases in which Mylan invokes this Court’s
jurisdiction for its own claims strengthen the notion that Mylan
can hardly be surprised, much less offended, by Otsuka’s
assertion of personal jurisdiction. See, e.g., Mylan Inc. v.
Apotex Inc., Civil Action No. 14-4560 (MAS/LHG); Mylan Pharma.,
Inc. v. Celgene Corp., Civil Action No. 14-2094 (ES/MAH). In
such cases, Mylan currently invokes the District of New Jersey’s
jurisdiction, rendering its present argument more puzzling.
24
circumstances, consent to the forum’s personal jurisdiction.
See, e.g., Pa. Fire Ins. Co. of Phila. v. Gold Issue Mining &
Milling Co., 243 U.S. 93, 95 (1917) (finding that a corporation
consented to personal jurisdiction in Missouri by appointing an
agent for service under a Missouri statute); Neirbo Co. v.
Bethlehem Shipbuilding Corp., 308 U.S. 165 (1939) (finding that
the defendant corporation waived its right to contest venue in
federal court in New York, by complying with a New York State
statute that required it to designate an agent for service of
process).
Indeed, in Pa. Fire Insurance Co., the Supreme Court
expressed “little doubt” that a foreign corporation’s
appointment of an agent for service of process suffices for
personal jurisdiction purposes, where the statute itself might
“rationally be held to go to that length.”
243 U.S. at 95.
In
Robert Mitchell Furniture Co. v. Selden Breck Const. Co., 257
U.S. 213 (1921), the Supreme Court then confirmed that
“secur[ing] local jurisdiction in respect of business transacted
within the State” served as the primary purpose of requiring the
appointment of an in-state agent for service.
Id. at 215.
In
so concluding, the Supreme Court emphasized that, in appointing
an agent, a foreign corporation “takes the risk of the
construction that will be put upon the statute and the scope of
the agency by the State Court.”
Id. at 216.
25
In that regard,
the Robert Mitchell Furniture Co. Court made clear that a
registration statute may suffice to establish jurisdiction,
provided that the state’s own construction of its statute
supports such a broad interpretation.
See id.
Nor does the fact that these decisions predated
International Shoe compel any contrary conclusion.
Indeed, the
Supreme Court has never explicitly overruled the holdings of
either case, and in the absence of such declaration, the Supreme
Court directs the continued application of its precedents.
See
Eberhart v. United States, 546 U.S. 12, 14–15, 19–20 (2005)
(noting that it was a “prudent course” for a lower court to
apply prior Supreme Court precedent that had not been expressly
overruled); Rodriguez de Quijas v. Shearson/Am. Exp., Inc., 490
U.S. 477, 484 (1989) (urging lower courts to follow Supreme
Court precedent that “has direct application in a case”).
Moreover, at least one Court of Appeals has expressly recognized
the continued vitality of this line of decisions.
See, e.g.,
King v. Am. Family Mut. Ins. Co., 632 F.3d 570, 576 n.6 (9th
Cir. 2011).
Therefore, this argument too lacks merit.
Nor can the Court find any support for Mylan’s position
that Daimler, in essence, precludes general jurisdiction by
consent, requiring instead that it be limited be limited to a
“corporation's place of incorporation and principal place of
business” or, in exceptional circumstances, an equivalent forum
26
in which the corporation could be found “at home.”
at 8-9.)
(Mylan’s Br.
Indeed, Daimler in its entirety contains but one
fleeting reference to the concept of jurisdiction by consent,
and this limited reference served only to distinguish between
traditional “consensual” jurisdiction and the “non-consensual
bases for jurisdiction” addressed in the decision, rather than
to cast any doubt on the continued vitality of consent-based
jurisdiction.
Acorda Therapeutics, Inc., 2015 WL 186833, at *12
(rejecting Mylan’s argument that Daimler, in effect, crowded out
consent-based jurisdiction); see also Forrest Labs., 2015 WL
880599, at *13 (concluding that Daimler mentions “consent to
jurisdiction” in a manner “that hurts, not helps, Mylan’s
argument”).
Moreover, though the Federal Circuit has not yet addressed
the consent-by-registration theory of personal jurisdiction,
this Court cannot ignore that the majority of federal Courts of
Appeals to have considered the question have concluded that
compliance with registration statutes may constitute consent to
personal jurisdiction.
In Bane v. Netlink, Inc., for example, the Third Circuit
explained that, “[b]y registering to do business in
Pennsylvania, [the defendant] ‘purposefully avail[ed] itself of
the privilege of conducting activities within the forum State,
this invoking the benefits and protections of its laws.’”
27
925
F.2d 637, 640 (3d Cir. 1991) (quoting Burger King Corp., 471
U.S. at 475).
As a result, the Bane court found the defendant
corporation’s authorization to do business in Pennsylvania
amounted to “consent to be sued in Pennsylvania courts,” because
the state statute required the defendant to designate the
Secretary of the Commonwealth as its agent for service of
process “in any action against it.”
925 F.2d 637, 640 (3d Cir.
1991) (internal quotation marks and citation omitted).11
In
Knowlton v. Allied Van Lines Inc., the Eighth Circuit similarly
concluded, based upon the text of a Minnesota state statute and
its interpretation by the Supreme Court of Minnesota, that
appointment of an agent for service of process conferred
“consent to the jurisdiction of Minnesota courts for any cause
of action, whether or not arising out of activities within the
state.”
900 F.2d 1196, 1199–1200 (8th Cir. 1990).
11
Finally, in
The Pennsylvania statute specifically stated that a foreign
corporation qualified as a “foreign corporation under the laws
of [the State]” then this “shall constitute a sufficient basis
of jurisdiction to enable the tribunals of this Commonwealth to
exercise general personal jurisdiction over such person[.]”
Bane, 925 F.2d at 640 (internal quotation marks and citations
omitted). The breadth of the Pennsylvania statute admittedly
exceeds that of the New Jersey statute, particularly to the
extent the Pennsylvania statute explicitly states that
registration enables the Pennsylvania state courts “to exercise
general personal jurisdiction” over registrants. Nevertheless,
the “difference between the wording of the Pennsylvania and New
Jersey statutes is not determinative,” Sadler v. Hallsmith SYSCO
Food Servs., No. 08-4423, 2009 WL 1096309, at *2 (D.N.J. 2009),
particularly given the New Jersey state court’s broad
interpretation of its own statute. See id.
28
Holloway v. Wright & Morrissey, Inc., the First Circuit found it
“well-settled that a corporation that authorizes an agent to
receive service of process in compliance with the requirements
of a state statute, consents to the exercise of personal
jurisdiction in any action” within the scope of the agent’s
authority. 739 F.2d 695, 697 (1st Cir. 1984).
As a result, the
Court found a “natural reading” of the New Hampshire statute
demonstrated that the defendant consented to personal
jurisdiction.12
Id.
Taken together, these precedents provide clear confirmation
that designation of an in-state agent for service of process in
accordance with a state registration statute may constitute
consent to personal jurisdiction, if supported by the breadth of
the statute’s text or interpretation.
12
See, e.g., Forrest Labs.,
Two other Circuits have similarly confirmed that viability of
consent-by-registration jurisdiction, but ultimately concluded
that the relevant state court precedent did not, standing alone,
subject foreign corporations to the jurisdiction of the relevant
state. See, e.g., King, 632 F.3d at 576-78 (finding no
jurisdiction where the Montana Supreme Court specifically
limited the reach of the relevant statute to the contacts of
foreign corporations in the state); Wenche Siemer v. Learjet
Acquisition Corp., 966 F.2d 179, 180–81 (5th Cir. 1992) (holding
that the defendant's appointment of an agent for service of
process pursuant to a Texas state statute did not amount to
consent to personal jurisdiction in Texas “on any dispute with
any party anywhere concerning any matter” because “[n]o Texas
state court decision has held that this provision acts as a
consent to jurisdiction over a corporation in a case such as
ours—that is where plaintiffs are nonresidents and the defendant
is not conducting substantial activity within the state”).
29
2015 WL 880599, at *6 (citing King v. Am. Family Mut. Ins. Co.,
632 F.3d 570, 576 n.6 (9th Cir. 2011)).
Therefore, the Court finds Mylan’s arguments concerning
consent-by-registration without merit.
Indeed, sister district
court recently addressed and rejected Mylan’s identical
arguments in connection with registration statutes in Delaware.
See generally Forest Labs., Inc., 2015 WL 880599, at *6.
Moreover, based upon Bane, Knowlton, Holloway, and the New
Jersey state court’s own interpretation of the scope of New
Jersey’s registration statute, the Court finds ample support to
conclude that Mylan Inc.’s and Mylan Pharma’s compliance with
the relevant registration statute amounted to consent to
personal jurisdiction.
Indeed, the State of New Jersey’s registration statute in
this instance requires that “every foreign corporation
authorized to transact business” in the State of New Jersey
“continuously maintain a registered office” and “a registered
agent having a business office identical with such registered
office.”
N.J.S.A. § 14A:4-1(1).
The statute, in turn, provides
that “[e]very registered agent shall be an agent of the
corporation ... upon whom process against the corporation may be
served.”
N.J.S.A. § 14A:4-2(1).
Mylan Inc. and Mylan Pharma concede that they complied with
the State of New Jersey’s registration requirements (see Tighe
30
Dec. at ¶ 8), including maintaining a registered agent in the
State for purposes of service of process.13
(See Exs. F & G to
Otsuka’s Opp’n (identifying Mylan Inc.’s and Mylan Pharma’s
registered agent as “Corporate Service Company 830 Bear Tavern
Road, West Trenton, NJ, 08628”).)
Moreover, the only New Jersey
state court that appears to have addressed the breadth of New
Jersey’s registration statute had little “hesitation” in
concluding that the “designation of an agent for the service of
process under N.J.S.A. 14A:4–1 amounted to a consent by
defendant to be sued in the state courts of New Jersey...”
Litton Indus. Sys., Inc. v. Kennedy Van Saun Corp., 283 A.2d
551, 556 (N.J. Super. Ct. Law Div. 1971), and numerous courts in
this district have reached an identical result.
See Sadler v.
Hallsmith SYSCO Food Servs., No. 08-4423, 2009 WL 1096309
(D.N.J. 2009) (finding that because defendant conceded that it
“registered to do business in New Jersey and ha[d] a registered
agent for service of process in New Jersey ... [that defendant]
consented to being sued in New Jersey”); Randolph Labs. v.
Specialties Dev. Corp., 62 F. Supp. 897, 898-99 (D.N.J. 1945)
(finding, under the Supreme Court’s decision in Neirbo, that
defendant corporation’s designation of an agent for service of
process in conformity with N.J.S.A. § 14:5-3 (now, N.J.S.A. §
13
Mylan Labs, by contrast, has not complied with New Jersey’s
registration statute, and therefore the Court cannot conclude
that Mylan Labs consented to the general jurisdiction of this
forum.
31
14A:4-2) constituted “consent” to be sued in a federal court in
the State of New Jersey); Da Cunha v. Grasselli Chem. Co., 46 F.
Supp. 28, 29 (D.N.J. 1942) (same).
Here, the Court finds that Mylan Inc. and Mylan Pharma
consented to the Court’s jurisdiction by registering to do
business in New Jersey, by appointing an in-state agent for
service of process in New Jersey, and by actually engaging in a
substantial amount of business in this State.14
(See Tighe Dec.
at ¶¶ 7-11 (noting that Mylan Inc. and Mylan Phama are licensed
to do business in this jurisdiction, maintain registered agents
14
For that reason, the Court rejects Mylan’s reliance upon
Agbottah v. Orange Lake Country Club, No. 12-1019, 2012 WL
2679440, at *3 (D.N.J. July 6, 2012); Smith v. S&S Dundalk Eng’g
Works, Ltd., 139 F. Supp. 2d 610, 620 (D.N.J. 2001); Kubin v.
Orange Lake Country Club, Inc., No. 10-1643, 2010 WL 3981908, at
*3 (D.N.J. Oct. 8, 2010), Atkinson & Mullen Travel Inc. v. N.Y.
Apple Tours Inc., No. 97-4460, 1998 WL 750355, at *2 (D.N.J.
Sept. 16, 1998), and Ratliff v. Cooper Labs., Inc., 444 F.2d
745, 748 (4th Cir. 1971), because in each case the courts found
a certificate to do business in New Jersey insufficient to
confer general jurisdiction, given the absence of any evidence
that the corporate defendant did indeed conduct business in New
Jersey. See, e.g., Ratliff, 444 F.2d at 748 (noting that “due
process require[s] a firmer foundation” that merely applying
“for the privilege of doing business”); Agbottah, 2012 WL
2679440, at *3-*4 (finding the defendant’s registration and
solicitation of business insufficient, where the plaintiffs did
not allege a volume of business, nor did “they describe any
agents, property, records, or other contacts” the defendant
“maintains in New Jersey”). Here, by contrast, Mylan Inc. and
Mylan Pharma concede that their New Jersey-activities extend far
beyond mere registration or solicitation of business. (See
generally Tighe Dec.) Indeed, both entities derive significant
revenue from New Jersey (see id. at ¶ 11; see also Tighe
Supplemental Dec. at ¶ 2), maintain active agents within the
State, solicit participants for clinical trials, and seek an
obtain Medicaid reimbursements with this forum.
32
in this jurisdiction, and generate very sizable revenues from
sales in this jurisdiction); see also Exs. H, I, and J to
Otsuka’s Opp’n (demonstrate that Mylan Inc. and Mylan Pharma
actively recruited participants for drug studies in New
Jersey).)
Nevertheless, because Mylan Labs has not similarly complied
with New Jersey’s registration statute, the Court turns to
whether the Court may exercise specific jurisdiction over Mylan
Labs.
3. The Court Lacks Specific Jurisdiction over Mylan
Labs
Otsuka does not focus upon the grounds on which the Court
could conceivably exercise specific jurisdiction over Mylan
Labs, Mylan Inc.’s Indian subsidiary.
at 9-12; Otsuka’s Sur-reply at 11.)
(See, e.g., Otsuka’s Br.
Rather, Otsuka primarily
hinges its position upon Mylan’s integrated nature, the
international scope of Mylan Labs’ operations, and the in-state
activities of its independent subsidiary.
¶ 9.)
(See, e.g., Compl. at
Otsuka, however, identifies no specific activities
directed at this forum that, in any way, relate to Otsuka’s
infringement claims.
For that reason, the Court readily rejects
Otsuka’s position that the Court possesses specific jurisdiction
over Mylan Labs.
Critically, in evaluating the existence of specific
jurisdiction, the Federal Circuit directs district courts to
33
consider: (1) whether the defendant purposefully directed
activities at residents of the forum; (2) whether the claim
arises out of or relates to those activities; and (3) whether,
given the circumstances, the assertion of personal jurisdiction
would be reasonable and fair. See, e.g., AFTG-TG, LLC, 689 F.3d
at 1361.
Here, however, Mylan Labs would appear to have no
appreciable connection to the alleged infringement issues that
give rise to this action.
Moreover, Otsuka has not alleged, nor
demonstrated, that Mylan Labs itself purposefully directed any
relevant claims-based contact towards this forum.15
Nor has
Otsuka provided any basis, much less addressed the relevant
standard, to impute the alleged jurisdictional contacts of Mylan
Labs’ subsidiaries to Mylan Labs itself for purposes of specific
jurisdiction in this litigation.
Therefore, Mylan Labs will be
dismissed for lack of personal jurisdiction.
15
As a result, the Court need not reach the issue of whether
future intent to distribute serves as a sufficient forum-related
contact for purposes of specific jurisdiction. The Court notes,
however, that the one district court in this Circuit to have
addressed this issue, AstraZeneca, ___ F. Supp. 3d ____, 2014 WL
5778016, at *3, found such future intent sufficient for
jurisdictional purposes principally as a result of the fact that
the generic defendant mailed its paragraph IV letter to the
brand name plaintiff in New Jersey. See generally id. No such
similar contact has been alleged in this instance, nor does
Mylan Labs appear to have participated, at all, in the
submission of Mylan Pharma’s ANDA.
34
CONCLUSION
For all of these reasons, Mylan’s motion to dismiss will be
denied as to Mylan Inc. and Mylan Pharma, and granted as to
Mylan Labs.
An accompanying Order will be entered.
March 23, 2015
Date
s/ Jerome B. Simandle
JEROME B. SIMANDLE
Chief U.S. District Judge
35
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