AstraZeneca AB v. Mylan Pharmaceuticals Inc.

Filing 26

OPINION. Signed by Judge Gregory M. Sleet on 11/5/2014. (mdb)

IN THE UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF DELAWARE
)
ASTRAZENECA AB,
)
)
Plaintiff,
)
)
v.
)
)
MYLAN PHARMACEUTICALS, INC.,
)
)
)
Defendant.
~~~~~~~~~~~)

Civil Action No. 14-696-GMS

Michael P. Kelly, Esquire, and Daniel M. Silver, Esquire, McCarter & English, LLP, counsel for
plaintiff. Of counsel: Charles E. Lipsey, Esquire, James B. Monroe, Esquire, Robert F. Shaffer,
Esquire, and Maximilienne Bishop, Esquire, Finnegan, Henderson, Farabow, Garret & Dunner,
L.L.P.
Richard L. Horwitz, Esquire, David E. Moore, Esquire, and Erich W. Struble, Esquire, Potter
Anderson & Corroon LLP, counsel for defendant. Of counsel: Joshua Mack, Esquire, and
Douglas H. Carsten, Esquire, Wilson Sonsini Goodrich & Rosati.

OPINION

November 5, 2014
Wilmington, Delaware

I.

INTRODUCTION
AstraZeneca AB ("AstraZeneca") filed a complaint against defendant Mylan

Pharmaceuticals, Inc. ("Mylan") on June 2, 2014, alleging patent infringement of U.S. Patent
Nos. 7,951,400 ("the '400 Patent"), RE44,186 ("the '186 Patent"), and 8,628,799 ("the '799
Patent"). (D.I. 1.) The cause of action was triggered when Mylan filed two Abbreviated New
Drug Applications ("ANDA") Nos. 205980 and 205981 with the U.S. Food and Drug
Administration ("FDA") for approval to market saxaglitptin hydrochloride tablets-generic
versions of AstraZeneca's ONGLYZA® drug product-and saxaglitptin hydrochloride and
metformin hydrochloride

extended-release

tablets-generic

versions

of AstraZeneca's

KOMBIGLYZE™ XR drug product-prior to expiration of the '400 Patent, the '186 Patent, and
the '799 Patent. (Id. iii! 1-3.)
Currently before the court is Mylan's motion to dismiss this suit for lack of personal
jurisdiction pursuant to Federal Rule of Civil Procedure 12(b)(2), filed on June 25, 2014. (D.I.
8.) For the reasons that follow, Mylan's motion to dismiss is denied.

II.

BACKGROUND
AstraZeneca is a company operating and existing under the laws of Sweden, with its

principal place of business in Sodertiilje, Sweden. (D.I. 1, if 4.) AstraZeneca's U.S. subsidiary,
AstraZeneca Pharmaceuticals LP ("AstraZeneca U.S.") is a limited partnership operating and
existing under the laws of Delaware, with its principal place of business in Wilmington,

2

Delaware.

(Id.

if 5.) Mylan is incorporated in West Virginia and has its principal place of

business in Morgantown, West Virginia. (Id.

if 7.)

AstraZeneca filed this lawsuit in the U.S. District Court for the District of Delaware. In
its complaint, AstraZeneca alleges:
10. This Court has jurisdiction over Mylan because, inter alia, this
action arises from actions of Mylan directed toward Delaware
and because Mylan has purposefully availed itself of the rights
and benefits of Delaware law by engaging in systematic and
continuous contacts with Delaware. Mylan regularly and
continuously transacts business within the State of Delaware,
including by selling pharmaceutical products in Delaware,
either on its own or through its affiliates. Upon information and
belief, Mylan derives substantial revenue from the sale of those
products in Delaware and has availed itself of the privilege of
conducting business within the State of Delaware.
11. Mylan has previously been sued in this judicial district without
objecting on the basis of lack of personal jurisdiction and has
availed itself of Delaware courts through the assertion of
counterclaims and by filing suits in Delaware.
(Id. irif 10, 11.)
In its motion to dismiss, Mylan challenges AstraZeneca's characterization of Mylan's
Delaware contacts. The two ANDAs at issue in this case were prepared in West Virginia and
filed in Maryland with the FDA. (D.I. 10,

if 10.) Mylan has no property or employees in

Delaware, and Mylan conducts essentially no direct sales in Delaware. (Id.

iii! 6-8.)

Mylan is,

however, registered to do business in Delaware and has appointed a registered agent to accept
service of process in Delaware, pursuant to 8 Del. C. §§ 371, 376. (D.I. 15, Ex. A.) Mylan has
also litigated in the District of Delaware numerous times, mostly as a defendant, but also as a
plaintiff in a handful of cases. (Id. Ex. E.)

3

III.

STANDARD OF REVIEW

The court must dismiss a case when it lacks personal jurisdiction over the defendant.
Fed. R. Civ. P. 12(b)(2); Freres v. SP! Pharma, Inc., 629 F. Supp. 2d 374, 382 (D. Del. 2009).
The plaintiff bears the burden of establishing that the defendants are properly subject to the
court's jurisdiction.

See JCT Pharm., Inc.

v. Boehringer Ingelheim Pharm., Inc.,

147 F. Supp. 2d 268, 270-71 (D. Del. 2001).
Personal jurisdiction is technically derived from two separate sources: state statutory law
and U.S. constitutional due process. !named Corp. v. Kuzmak, 249 F.3d 1356, 1359-60 (Fed.
Cir. 2001). The Delaware long-arm statute, however, has been construed "broadly to confer
jurisdiction to the maximum extent possible under the Due Process Clause," so the focus of the
inquiry traditionally rests on the constitutional component. 10 Del. C. § 3104; s.ee Merck & Co.,

Inc. v. Barr Labs., Inc., 179 F. Supp. 2d 368, 372 (D. Del. 2002) (citing Hercules Inc. v. Leu
Trust & Banking Ltd., 611 A.2d 476, 480-81 (Del. 1992)). 1
"[D]ue process requires only that in order to subject a defendant to. a judgment in
personam, if he be not present within the territory of the forum, he have certain minimum
contacts with it such that the maintenance of the suit does not offend traditional notions of fair
play and substantial justice."

Int'/ Shoe Co. v. State of Wash., Office of Unemployment

Compensation & Placement, 326 U.S. 310, 316 (1945) (internal quotation marks omitted). Since
the Supreme Court initially announced this rule in International Shoe, the doctrine has split into
two categories: specific and general jurisdiction.
1

Specific jurisdiction exists where "the

The court recognizes that "Delaware law is ... unclear as to whether or not the long arm statute is
coextensive with the due process clause," and whether separate analyses are required. See Commissariat A
L'Energie Atomique v. Chi Mei Optoelecs. Corp., 395 F.3d 1315, 1322 (Fed. Cir. 2005); see also JCT Pharrn.,
147 F. Supp. 2d at 271 n.4 ("[T]he Delaware Supreme Court has not collapsed the analysis under the Delaware longarm statute into the constitutional due process analysis, as some courts have done.") The parties have not challenged
jurisdiction under Delaware's long-arm statute, however, so the court directs its attention to the constitutional
analysis.

4

defendant has 'purposefully directed' his activities at residents of the forum, and the litigation
results from alleged injuries that 'arise out of or relate to' those activities." Burger King Corp. v.
Rudzewicz, 471 U.S. 462, 472-73 (1985) (internal citations omitted) (quoting Keeton v. Hustler
Magazine, Inc., 465 U.S. 770, 774 (1984); Helicopteros Nacionales de Colombia, S.A. v.
Hall, 466 U.S. 408, 414 (1984)). In contrast, general jurisdiction does not require that the cause

of action arise out of contacts with the forum state. Helicopteros, 466 U.S. 408 at 421. Rather,
general jurisdiction exists where the defendant's contacts with the forum "are so continuous and
systematic as to render it essentially at home in the forum State." Daimler AG v. Bauman,
134 S. Ct. 746, 761 (2014) (quoting Goodyear Dunlop Tires Operations, S.A. v. Brown,
131 S. Ct. 2846, 2851 (2011)).

Recent Supreme Court opinions confirm that "specific

jurisdiction has become the centerpiece of moqem jurisdiction theory," whereas general
jurisdiction--0ften referred to as "all-purpose" jurisdiction-"[has played] a reduced role." Id.
at 755 (alteration in original) (quoting Goodyear, 131 S. Ct. at 2854).
IV.

DISCUSSION

Faced with Mylan's challenge to personal jurisdiction, AstraZeneca "bears the burden of
showing the basis for this Court's jurisdiction."

See Power Integrations, Inc. v. BCD

Semiconductor Corp., 547 F. Supp. 2d 365, 369 (D. Del. 2008). AstraZeneca maintains that (1)

Mylan has consented to general jurisdiction in Delaware, (2) Mylan is subject to specific
jurisdiction in Delaware, and (3) Mylan is subject to general jurisdiction in Delaware. (D.I. 15.)
The court addresses each of these arguments. 2

2

For the sake of convenience and clarity, the court analyzes AstraZeneca's arguments in a different order
from that of the briefing.

5

A. General Jurisdiction
AstraZeneca argues that Mylan's contacts with Delaware are sufficient to render it
"essentially at home" here. AstraZeneca points to the fact that Mylan is registered to do business
in Delaware and allegedly derives substantial revenue from the sales of its products in Delaware,
via an "extensive network of physicians, hospitals, long-term care facilities, group purchasing
organizations, retailers, and wholesalers." (Id. at 10-11.) AstraZeneca also alleges that Mylan is
"at home in Delaware district court" because of its involvement in numerous patent- and ANDArelated lawsuits over the past two decades. (Id. at 11 ; Ex. E.)
In ANDA litigation, general jurisdiction traditionally provided the basis to assert
jurisdiction over generic drug company defendants.

See, e.g., In re Cyclobenzaprine

Hydrochloride Extendeq-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). Since the Supreme Court's recent decision in Daimler, however, the standard for
exercising general jurisdiction has shifted. See Daimler, 134 S. Ct. 746. The court finds that
AstraZeneca has failed to allege contacts sufficient to render Mylan at home in Delaware, in light
of Daimler.
In Daimler, elaborating on its previous decision in Goodyear, 131 S. Ct. 2846, the
Supreme Court explained that a corporation is "at home" for the purposes of general jurisdiction
in only a narrow set of circumstances: "With respect to a corporation, the place of incorporation
and principal place of business are paradig[m] ... bases for general jurisdiction." Daimler,
134 S. Ct. at 760 (alteration in original) (internal quotations marks omitted). The Court was
careful to emphasize that the "place of incorporation" and the "principal place of business"

6

exemplars were not exhaustive. Id. at 760-61. But at the same time, the Court rejected the idea
that "continuous and systematic" contacts, alone, are sufficient to confer jurisdiction. Id. at 76162 (finding such a test for general jurisdiction would be ''unacceptably grasping" and
"exorbitant"). The role of general jurisdiction is a limited one: "afford plaintiffs recourse to at
least one clear and certain forum in which a corporate defendant may be sued on any and all
claims." Id. at 760. 3
The court finds that AstraZeneca has failed to allege sufficient facts to demonstrate that
Mylan is "essentially at home" in Delaware.

First, concerning Mylan's business contacts,

AstraZeneca notes only that Mylan is registered to do business in Delaware and has a broad
network of third-party contacts within the state. (D.I. 15 at 10-11.) Such allegations fail to
show activity "comparable to domestic enterprise in [Delaware]." See Daimler, 134 S. Ct. at
758 n.11. Indeed, AstraZeneca does not identify any Mylan business activity in Delaware that
sets it apart from other states. As AstraZeneca acknowledges, Mylan is "one of the largest
generic pharmaceutical companies in the world." (D.I. 15 at 10.) Upholding jurisdiction on
these allegations alone would permit the "exercise of general jurisdiction in every [s]tate," a
result specifically precluded by the Supreme Court. See Daimler, 134 S. Ct. at 761.
Second, AstraZeneca argues that Mylan is at home in Delaware because of Mylan's
extensive litigation history in this district.

The court acknowledges the creativity of this

argument but ultimately finds that familiarity with the court system of Delaware is insufficient to
render a defendant at home here, as envisioned by Daimler. Although it left open the possibility
that forum activity involving something other than the paradigmatic examples (place of

3

The court recognizes that Daimler dealt with a very different set of facts than those in the present case,
but the Supreme Court's analysis and discussion of general jurisdiction did not place any limits on the application of
the rule announced.

7

incorporation or principal place of business) could satisfy general jurisdiction, the Supreme
Court highlighted that such a fact pattern would be an "exceptional case." Id. at 761 n.19. The
court finds that Mylan's litigation history in Delaware fails to rise to this level. Mylan has only
initiated six lawsuits in the District of Delaware over the past two decades. (D.I. 15, Ex. E.) It is
true that Mylan has defended against many more lawsuits in Delaware during this time, but such
activity is not "so 'continuous and systematic' as to render them essentially at home." See
Daimler, 134 S. Ct. at 754 (quoting Goodyear, 131 S. Ct. 2851 ); see also In re Rosuvastatin
Calcium Patent Litig., MDL No. 08-1949, 2009 WL 4800702, at *6 (D. Del. Dec. 11, 2009)
("Filing a counterclaim and defending a lawsuit, and consensually participating in other cases, is
not enough to serve as a basis for a finding of a general presence in Delaware for all
cases.... ") .
Mylan's place of incorporation and principal place of business are in West Virginia.
There is no dispute that Mylan is subject to general jurisdiction in West Virginia. Moreover, the
court does not rule out the possibility that Mylan may be subject to general jurisdiction in
another forum, in the event that its contacts are sufficient to render it at home there.

But

AstraZeneca has not established that Mylan is properly subject to general jurisdiction in
Delaware. The court rejects AstraZeneca's general jurisdiction justification.4
B. Consent to General Jurisdiction
AstraZeneca also argues that Mylan has consented to be subject to Delaware's general
jurisdiction by registering to do business in the state and by appointing a registered agent to
accept service of process. (D.I. 15 at 4-7; Ex. A.) AstraZeneca contends: "When there is
4

The court is not convinced that AstraZeneca's request for jurisdictional discovery would add anything to
the court's calculus. (D.I. 15 at 11.) Even if AstraZeneca were able to obtain more exact figures concerning
Mylan's business dealing with Delaware, there is nothing to suggest that such dealings would be "exceptional" as
compared to other states. See Daimler, 134 S. Ct. at 761 n.19.

8

consent, that ends the jurisdictional inquiry.... Consent to personal jurisdiction obviates the
need to consider due proess and minimum contacts." (Id. at 5.)
AstraZeneca maintains that Supreme Court cases holding that personal jurisdiction is
satisfied merely by complying with state business registration statutes remain a viable path to
finding jurisdiction even after International Shoe and its progeny. See Neirbo Co. v. Bethlehem
Shipbuilding Corp., 308 U.S. 165 (1939); Penn. Fire Ins. Co. of Phi/a. v. Gold Issue Min. &
Mill. Co., 243 U.S. 93 (1917).

Evidently there is a circuit split as to whether this type of

"statutory consent" is an adequate basis on which to ground a finding of personal jurisdiction.
Several courts have held that a minimum-contacts analysis that meets the dictates of
International Shoe is required. See, e.g., Ratliff v. Cooper Labs., Inc., 444 F.2d 745, 748 (4th
Cir. 1971) ("The principles of due process require a firmer foundation than mere cpmpliance
with state domestication statutes."); Wenche Siemer v. Learjet Acquisition Corp., 966 F.2d 179,
183 (5th Cir. 1992) ("Not only does the mere act of registering an agent not create Learjet's
general business presence in Texas, it also does not act as consent to be hauled into Texas courts
on any dispute with any party anywhere concerning any matter.").

Nonetheless, others,

including the Third Circuit, have upheld a finding of general jurisdiction on statutory registration
grounds alone. See, e.g., Bane v. Net/ink, Inc., 925 F.2d 637, 640 (3d Cir. 1991) ("We need not
decide whether authorization to do business in Pennsylvania is a 'continuous and systematic'
contact with the Commonwealth ... because such registration by a foreign corporation carries
with it consent to be sued in Pennsylvania courts."); Knowlton v. Allied Van Lines, Inc.,
900 F.2d 1196 (8th Cir. 1990) ("We conclude that appointment of an agent for service of process
under [the Minnesota statute] gives consent to the jurisdiction of Minnesota courts for any cause

9

of action, whether or not arising out of activities within the state. Such consent is a valid basis of
personal jurisdiction,

and

resort

to

minimum-contacts

or

due-process

analysis

to

justify ... jurisdiction is unnecessary.") The Supreme Court has never expressly addressed the
continuing vitality of cases like Neirbo and Gold Issue in the wake of International Shoe. But
see Shaffer v. Heitner, 433 U.S. 186, 212 (1977) ("[A]ll assertions of state-court jurisdiction
must be evaluated according to the standards set forth in International Shoe and its progeny).
Unsurprisingly, there is also little guidance as to Daimler's impact, if any, on this question.
The Delaware statutes at issue in this case are sections 371 and 376. 8 Del. C. §§ 371,
376.

Section 371 provides mandatory registration requirements for all foreign (i.e., non-

Delaware) corporations seeking to "do business" in Delaware. Section 376 provides that process
may be served on foreign corporations in

complianc~

with section 371 via a designated

registered agent. AstraZeneca argues that the Delaware Supreme Court has already established
that compliance with these statutes suffices to create express consent "to the exercise of general
jurisdiction by the Courts of Delaware." See Sternberg v. 0 'Neil, 550 A.2d 1105, 1116 (Del.
1988). AstraZeneca asserts that Daimler plays no role in the consent analysis because that case
dealt with the minimum-contacts aspect of International Shoe, which is distinct from the
question of consent. See id. at 1111 ("[E]xpress consent is a valid basis for the exercise of
general jurisdiction in the absence of any other basis for the exercise of jurisdiction, i.e.
'minimum contacts."').
The court finds, however, that Daimler does weigh on this issue.

Both consent and

minimum contacts (and all questions regarding personal jurisdiction) are rooted in due process.
Just as minimum contacts must be present so as not to offend "traditional notions of fair play and

10

substantial justice," the defendant's alleged "consent" to jurisdiction must do the same. See Int 'l

Shoe, 326 U.S. at 316. The Supreme Court's discussion of due process in Daimler, therefore,
informs the court's analysis here. In holding that "continuous and systematic contacts" alone are
insufficient to establish general jurisdiction, the Supreme Court rejected the idea that a company
could be haled into court merely for "doing business" in a state. Daimler, 134 S. Ct. at 761-62.
Such a theory, the Court held, ''would scarcely permit out-of-state defendants 'to structure their
primary conduct with some minimum assurance as to where that conduct will and will not render
them liable to suit.'" Id.
In light of the holding m Daimler, the court finds that Mylan's compliance with
Delaware's registration statutes-mandatory for doing business within the state-cannot
constitute consent to jurisdict\on, and the Delaware Supreme Court's decision in Sternberg can
no longer be said to comport with federal due process. A large number of states have enacted
foreign corporation registration statutes similar to Delaware; Mylan itself is registered in over a
dozen different states. 5 (D.I .. 18, Exs. C-P.) Finding mere compliance with such statutes
sufficient to satisfy jurisdiction would expose companies with a national presence (such as
Mylan) to suit all over the country, a result specifically at odds with Daimler.

Daimler,

134 S. Ct. at 761-62. Moreover, a contrary holding would lead to perverse incentives: foreign
companies that comply with the statute in order to conduct business lawfully are disadvantaged,
whereas those who do not register and do business in Delaware illegally are immune.

5

Mercedes Benz USA, the subsidiary at issue in Daimler, was a foreign corporation registered to do
business in California, with an appointed agent for service of process. (D.I. 18, Ex. A.) The Supreme Court did not
address the question of whether this amounted to consent.

11

Administrative statutes like Delaware's sections 371 and 376 merely outline procedures
for doing business in the state; compliance does not amount to consent to jurisdiction or waiver
of due process. 6 Mylan did not consent to general jurisdiction in this case.

C. Specific Jurisdiction
Finally, AstraZeneca argues that Mylan is subject to specific jurisdiction in Delaware.
The court notes that specific jurisdiction has historically been disfavored by courts as a basis to
exercise jurisdiction over generic drug company defendants in ANDA cases. See, e.g., Zeneca

Ltd. v. Mylan Pharm., Inc., 173 F.3d 829 (Fed. Cir. 1999); In re Cyclobenzaprine,
693 F. Supp. 2d at 420-21; Glaxo Inc. v. Genpharm Pharm. Inc., 796 F. Supp. 872, 875-76
(E.D.N.C. 1992).

The court finds it necessary, however, to look closely at AstraZeneca's

argument now that the standard for general jurisdiction-the typical avenue for bringing ANDA
cases-has changed. Before discussing the particulars of specific jurisdiction, the court believes
some background on ANDA litigation is helpful.
ANDA litigation is a product of the Drug Price Competition and Patent Term Restoration
Act of 1984----otherwise known as the "Hatch-Waxman Act." Pub. L. No. 98-417, 98 Stat. 1585
(1984).

The Hatch-Waxman Act created the ANDA process to increase the availability of

generic versions of drugs and reduce delays in FDA approval. 21 U.S.C. §355(j); H.R. Rep. No.
98-856, pt. 1, at 14 (1984). Along with the ANDA mechanism, Congress also amended the

6

The court limits its holding to Delaware's statutes specifically. The court does not address the more
difficult question raised when state statutes expressly indicate that foreign corporations consent to general
jurisdiction by complying with the statutes. See, e.g., Bane, 925 F.2d at 640 ("The existence of any of the following
relationships between a person and this Commonwealth shall constitute a sufficient basis of jurisdiction to enable
the tribunals of this Commonwealth to exercise general personal jurisdiction over such person: ... (i) Incorporation
under or qualification as a foreign corporation under the laws of this Commonwealth." (quoting 42 Pa. Cons. Stat.
Ann. § 5301)).

12

patent laws. Pre-ANDA testing and development activity was exempted, 7 whereas the actual
filing of an ANDA for a drug with patent protection triggered a statutory cause of action for
patent holders. 8 Thus, the Hatch-Waxman Act attempted to strike a balance: generic drug
companies were given greater protection in developing their drugs, but the brand or pioneer drug
companies were given the right to initiate an infringement lawsuit before the generic companies
could go to market. 9
This history helps to inform the court's approach to its analysis of AstraZeneca's specific
jurisdiction argument. As stated above, specific jurisdiction exists where "the defendant has
'purposefully directed' his activities at residents of the forum, and the litigation results from
alleged injuries that 'arise out of or relate to' those activities." Burger King, 471 U.S. at 472-73;
see also Nuance Comrnc'ns, Inc. v. Abbyy Software House, 626 F.3d 1222, 1231 (Fed. Cir. 2010)

(citing Akra Corp. v. Luker, 45 F.3d 1541, 1545-46 (Fed. Cir. 1995)). The difficulty in ANDA
cases is that infringement under§ 271(e)(2) is "a highly artificial act," precisely because of the
goals of the Hatch-Waxman Act. See Eli Lilly & Co. v. Medtronic, Inc., 496 U.S. 661 (1990).
As a statutory creation, distinct from making, using, or selling a patented technology,
infringement under § 271 (e)(2) has no readily apparent situs of injury for the purpose of finding

7
35 U.S.C. § 271(e)(l). Previously, generic drug companies faced significant barriers because drug
development and experimentation qualified as infringement. See Roche Prods., Inc. v. Bolar Pharm. Co., Inc.,
733 F.2d 858 (Fed. Cir. 1984).
8
Section 271(e)(2) states, in relevant part:
It shall be an act of infringement to submit(A) an application under [21 U.S.C. § 355(j)] for a drug claimed in a patent or
the use of which is claimed in a patent ... if the purpose of such
submission is to obtain approval under such Act to engage in the
commercial manufacture, use, or sale of a drug, veterinary biological
product, or biological product claimed in a patent or the use of which is
claimed in a patent before the expiration of such patent.
35 U.S.C. § 271(e)(2).
9
"[T]his procedure fairly balances the rights of a patent owner to prevent others from making, using, or
selling its patented product and the rights of third parties to contest the validity of a patent or to market a product
which they believe is not claimed by a patent." H.R. Rep. No. 98-856, pt. 1, at 28 (1984).

13

specific jurisdiction. Another peculiarity of the Hatch-Waxman Act is that it builds patent
litigation into the FDA approval process. Patent holders have forty-five days after receiving a
"paragraph IV" certification from the generic company to initiate an infringement lawsuit; the
lawsuit, if filed, triggers an automatic thirty-month stay for the FDA's approval of the generic.
Thus, ANDA litigation is unlike other patent infringement litigation: The injury is abstract,
making it difficult to point to a location out of which the injury "arises" for jurisdictional
purposes.

At the same time, defending against an infringement lawsuit is an inherent and

expected part of the ANDA filer's business. To put it simply: a lawsuit is often inevitable, but it
is not clear where it should be held. 10 This challenge is compounded by Daimler's narrowing of
the doctrine of general jurisdiction.
With this background in mind, the court turns to the issue at hand and determines

~hat

Mylan is subject to specific jurisdiction in Delaware. "That the Supreme Court has viewed the
tortious act [of submitting an ANDA] as 'highly artificial' ... is not a proper reason ... to
conclude that the ANDA filing is not a 'real act' with 'actual consequences."'
173 F.3d at 833-34 (quoting Eli Lilly, 496 U.S. at 663-64).

Zeneca,

The court finds that these

consequences are suffered in Delaware. Mylan argues its activities are not purposefully directed
at the state of Delaware, where AstraZeneca U.S. is organized. (D.I. 18 at 5-7.) Mylan's
argument, however, creates the untenable position that its conduct is not directed to any
jurisdiction. The Federal Circuit in Zeneca eliminated the possibility that Maryland (the location
of the FDA and where AND As are filed) could exercise specific jurisdiction over ANDA filers,
in order to avoid creating a "supercourt" with jurisdiction in all cases. Zeneca, 173 F.3d at 832.

10

"While it is clear what Congress intended to accomplish in terms of substantive legal effects, it is unclear
what effect, if any, Congress intended section 271(e)(2) would have on the personal jurisdiction of a defendant."
Zeneca Ltd. v. Mylan Phann., Inc., 968 F. Supp. 268, 273 (W.D. Pa. 1997), rev 'd 173 F.3d 829 (Fed. Cir. 1999).

14

Judge Rader's concurring opinion stated that "Mylan's contacts are not actually with the state of
Maryland at all.

Rather Mylan's contacts involve the federal government whose office for

receipt of ANDAs happens to be within that state." Id. at 835 (Rader, J., concurring). 11 The
court finds that the only possible alternative forum is the state of residence for the patent
holder. 12
The court is cognizant of the fact that a plaintiffs contacts with the forum state should
not be imputed to the defendant for the purposes of establishing minimum contacts. See Walden
v. Fiore, 134 S. Ct. 1115, 1122 (2014) ("We have consistently rejected attempts to satisfy the

defendant-focused 'minimum contacts' inquiry by demonstrating contacts between the plaintiff
(or third parties) and the forum State."). Mylan's contact with Delaware is not illusory, however.
Mylan sent its paragraph IV certification to AstraZeneca U.S. ip Delaware, thus triggering the
forty-five-day countdown for AstraZeneca to file a lawsuit-a "real act with actual
consequences." See Zeneca, 173 F.3d at 833-34 (internal quotation marks omitted).

Thus,

AstraZeneca's cause of action-albeit the "artificial" injury created by§ 271(e)(2)-arose out of
Mylan's contact with AstraZeneca in Delaware. Moreover, Mylan cannot plausibly argue that it
could not "reasonably anticipate being haled into court" in Delaware when patent litigation is an
integral part of a generic drug company's business. See Burger King, 471 U.S. at 474 (quoting
World-Wide Volkswagen Corp. v. Woodson, 444 U.S. 286, 295 (1980)).

11

In his opinion for the court, Judge Gajarsa disagreed with Judge Rader's view on this matter; he,
however, used the "government contacts exception" to find specific jurisdiction did not exist. Zeneca, 173 F.3d at
833-34. Under either Judge Gajarsa's or Judge Rader's opinions, Maryland was eliminated as a forum for specific
jurisdiction in ANDA cases.
12 Mylan's reliance on Glaxo Inc. v. Genpharm Pharmaceuticals, Inc. is unavailing. 796 F. Supp. 872
(E.D.N.C. 1992). The case predates Zeneca-in fact the North Carolina court ultimately transferred the case to the
District of Maryland, the very result that Zeneca found impermissible. Id. at 876 & n.9. The court is not persuaded
that Glaxo retains any meaningful viability.

15

The court is convinced that the act of filing an ANDA and the paragraph IV notification
provide sufficient minimum contacts with the state of Delaware under a specific jurisdiction
analysis. 13 Furthermore, as discussed above, the exercise of jurisdiction must comport with
"traditional notions of fair play and substantial justice." See Int 'l Shoe, 326 U.S. at 316, 324-26.
This factor, the court finds, weighs strongly in favor of exercising specific jurisdiction. Mylan is
no stranger to ANDA litigation in Delaware, and the court is not convinced that it would be
''unfair" to subject Mylan to suit here. (D.I. 15, Ex. E.) Conversely, AstraZeneca would be
substantially burdened if forced to bring lawsuits against each ANDA filer in the defendants'
home states. Such a result would be inconsistent with the "balance" that Congress sought to
create in passing the Hatch-Waxman Act. The Supreme Court has stated:
Implicit in this emphasis on reasonableness is the understanding
that the burden on the defendant, while always a primary concern,
will in an appropriate case be considered in light of other relevant
factors, including the forum State's interest in adjudicating the
dispute, the plaintiff's interest in obtaining convenient and
effective relief, at least when that interest is not adequately
protected by the plaintiff's power to choose the forum, the
interstate judicial system's interest in obtaining the most efficient
resolution of controversies; and the shared interest of the several
States in furthering fundamental substantive social policies.
World-Wide Volkswagen, 444 U.S. at 292 (emphasis added) (internal citations omitted). Having

found no meaningful burden on Mylan in defending in Delaware, the court considers these

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Several district courts have found that the state in which the ANDA is prepared or the state where the
generic drug is tested or developed is the proper forum for the exercise of specific jurisdiction. See, e.g., Pfizer Inc.
v. Apotex, Inc., No. 08-cv-00984-LDD, 2009 WL 2843288, at *3 n.5 (D. Del. Aug. 13, 2009); Pfizer Inc. v. Synthon
Holding, B. V, 386 F. Supp. 2d 666, 674-75 (M.D.N.C. 2005); see also lntendis, Inc. v. River's Edge Phann., LLC,
No. 11-2838 (FSH)(PS), 2011 WL 5513195, at *4 (D.N.J. Nov. 10, 2011). The court is not convinced that the focus
should be on these factors. First, § 271(e)(l) explicitly exempts drug development activity as a basis for
infringement. 35 U.S.C. § 271(e)(l). It strikes the court as odd to nonetheless treat such activity as an injury for the
purposes of finding specific jurisdiction in ANDA cases. Second, because of the "artificial" nature of the injury
under§ 271(e)(2), the act of merely preparing an ANDA does not create a harm. Only the act of filing the ANDA,
and thus triggering the patent holder's forty-five days to initiate a lawsuit, is recognized as an injury giving rise to
potential infringement liability. § 271(e)(2).

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additional factors and determines that they favor the exercise of specific jurisdiction.

In

particular, under Mylan's theory, AstraZeneca would only be able to bring suit in Mylan's home
state of West Virginia. Again, the Hatch-Waxman Act was not intended to burden patent holders
or reduce the patent protection afforded in ANDA cases; limiting AstraZeneca's choice of forum
to West Virginia is not "adequ[ate] protection." See id. Additionally, judicial efficiency weighs
in favor of exercising specific jurisdiction. In this case, which is by no means unique in the
ANDA litigation sphere, AstraZeneca has filed suit against no fewer than ten generic defendant
groups. Resolution of these cases in a single district would promote judicial economy and avoid
the possibility of inconsistent outcomes.
In sum, it is the court's view that Mylan is appropriately subject to specific jurisdiction in
Delaware. AstraZeneca's cause of action under § 271(e)(2) arises out of Mylan's activities,
which were purposefully directed at AstraZeneca in the state of Delaware. Considerations of fair
play and substantial justice also justify the exercise of jurisdiction. Mylan's motion to dismiss
for lack of personal jurisdiction (D.1. 8) is denied.
V.

CONCLUSION

For the foregoing reasons, Mylan' s motion to dismiss for lack of personal jurisdiction is
denied. (D.1. 8.)

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