Millennium Pharmaceuticals Inc. v. Pharmascience Inc. et al

Filing 20

MEMORANDUM. Signed by Judge Gregory M. Sleet on 6/10/2016. (mdb)

IN THE UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF DELAWARE

MILLENNIUM PHARMACEUTICALS, INC.,
Plaintiff,
v.
PHARMASCIENCE INC. and
PHARMASCIENCE LABORATORIES INC.,
Defendants.

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C.A. No. 15-702-GMS

MEMORANDUM
I.

INTRODUCTION
On August 13, 2015, the plaintiff, Millennium Pharmaceutical Inc. ("Millennium"), filed

· this lawsuit against defendant Pharmascience Laboratories Inc., ("PSL") and defendant
Pharmascience Inc. ("PSI") (collectively ''the Pharmascience Defendants"). (D.I. 1.) The
Complaint alleges that the Pharmascience Defendants collaborated on filing and notifying
Millennium of an Abbreviated New Drug Application ("ANDA") for a generic version of the
drug VELCADE® (bortezomib). (Id.) The Complaint further alleges infringement of two of
Millennium's drug patents: U.S. Patent Nos. 6,713,446 (the "'446 patent") and 6,958,319 (the
"'319 patent"). (Id.) Presently before the court is PSI's motion to dismiss the complaint for lack
of personal jurisdiction under 12(b)(2) of the Federal Rules of Civil Procedure (D.I. 6) and PSL's
motion to dismiss the complaint for lack of personal jurisdiction and for failure to state a claim

~nder

12(b)(6) of the Federal Rules of Civil Procedure. (D.I. 9.) For the reasons below, the

court will deny the motions in part. 1

II.

BACKGROUND
PSI filed ANDA No. 208392 with the U.S. Food and Drug Administration ("FDA").

(D.I. 1 at if 1.) PSI's ANDA seeks "approval to manufacture and sell a generic version of
VELCADE® for Injec~ion before the expiration of U.S. Patent Nos. 6,713,446 and 6,958,319."
(Id.) Millennium asserts that it is the exclusive licensee of the '446 and '319 patents, which are

listed in the FDA's "Orange Book" as encompassing VELCADE®. (Id. at ifif 22, 25.) On June
29, 2015, PSI sent its ANDA Notice Letter to Millennium, which included a "paragraph IV
certification" that the '446 and '319 patents were invalid, unenforceable or would not be
infringed by PSI's proposed bortezomib product. See 21 U.S.C. § 355(j)(2)(A)(vii)(IV); (D.I. 1
at ifif 26-27.) On August 13, 2015, Millennium brought suit alleging that the Pharmascience
Defendants collaborated on filing and notifying Millennium of an ANDA for a generic version of
the drug VELCADE® (bortezomib ).
On September 3, 2015, PSI moved to dismiss the complaint for fack of personal
jurisdiction. (D.I. 6.) That same day, PSL moved to dismiss the complaint for lack of personal
jurisdiction and for failure to state a claim. (D.I. 10.) Millennium opposed dismissal. (D.I. 13.)
Millennium relied upon this court's decision in AstraZeneca AB v. Mylan Pharm., Inc., which
held that the act of filing an ANDA application that potentially infringes the patent of a Delaware
entity provides sufficient minimum contacts with the state of Delaware under a specific

1
The court will dismiss PSL for lack of personal jurisdiction. Therefore, the court need not address the
arguments that PSL raises regarding lack of subject matter jurisdiction, which in any event are without merit with
regard to PSI. See AstraZeneca Phanns. LP v. Apotex Corp., 669 F.3d 1370, 1377 (Fed. Cir. 2012) (once a patentee
alleges infringement there is subject matter). See also 28 U.S.C. § 1338 (providing exclusive federal jurisdiction
over patent cases).

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jurisdiction analysis, but also held that the court lacked general jurisdiction in that case. 72 F.
Supp. 3d 549,

5~9-60

(D. Del. 2014). Subsequently, that case was consolidated for appeal with

Acorda Therapeutics, Inc. v. Mylan Pharm. Inc. and affirmed. Acorda Therapeutics Inc. v.
MylanPharm. Inc., 817 F.3d 755 (Fed. Cir. 2016). See also Acorda Therapeutics, Inc. v. Mylan
Pharm. Inc., 78 F. Supp. 3d 572 (D. Del. 2015) (holding that the court had specific jurisdiction
and general jurisdiction over Mylan.)
On March 18, 2016, the Federal Circuit held in Acorda that the act of filing an ANDA
with the FDA for a generic drug product subjected Mylan to specific personal jurisdiction in
Delaware because Mylan would engage in marketing and selling its intended product in
Delaware. 817 F.3d at 757. The Acorda court reasoned that in filing its ANDAs, Mylan
indicated· an intention to sell that product in every state, including Delaware. Id. at 763-64. The
court concluded that "the minimum-contacts standard is satisfied by the particular actions Mylan
has already taken-its ANDA filings-for the purpose of engaging in that injury-causing and
allegedly wrongful marketing conduct in Delaware." Id. at 760.

III.

STANDARD OF REVIEW
Under Federal Rule of Civil Procedure 12(b)(2), a court must dismiss a case when it lacks

personal jurisdiction over the defendant. Fed. R. Civ. P. 12(b)(2); Freres v. SPI Pharma, Inc.,
629 F. Supp. 2d 374, 382 (D. Del. 2009). The plaintiff bears the burden of proving that personal
jurisdiction is proper. JCT Pharms., Inc. v. Boehringer Ingelheim Pharms., Inc., 147 F. Supp. 2d
268, 270-71 (D. Del. 2001). Likewise, the plaintiff"must sustain its burden of proof in
establishing jurisdictional facts through sworn affidavits or other competent evidence." Time
Share Vacation Club v. Atlantic Resorts, Ltd., 735 F.2d 61, 66 n.9 (3d Cir. 1984); see also
Autogenomics, Inc. v. Oxford Gene Tech. Ltd., 566 F.3d 1012, 1023 (Fed. Cir. 2009).

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To determine whether there is personal jurisdiction, the court must first determine
whether it has jurisdiction over the defendant under the Delaware long-arm statute. 10 Del. C. §
3104. See Bell Helicopter Textron, Inc. v. C & C Helicopter Sales, Inc., 295 F.Supp.2d 400,
402-03 (D. Del. 2002). 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 Corp. v. Rudzewicz, 471 U.S. 462,
472-73 (1985); see also Nuance Commc'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)). A
defendant is subject to jurisdiction under Delaware's long-arm statute, Del. Code Ann. tit. 10, §
3104, as long as Delaware's exercise of personal jurisdiction over the defendant would be
consistent with the Fourteenth Amendment's Due Process Clause. Acorda Therapeutics Inc. v.

Mylan Pharm. Inc., 817 F.3d 755, 759 (Fed. Cir. 2016). Thus, the court must determine whether
an exercise of jurisdiction violates the defendant's Constitutional right to due process. Id. .
A court·may exercise specific personal jurisdiction without violating the Due Process
Clause when the defendant "ha[s] certain minimum contacts with [the forum] such that the
maintenance of the suit does not offend 'traditional notions of fair play and substantial justice."'

Int'! Shoe Co. v. Washington, 326 U.S. 310, 316 (1945) (citing Milliken v. Meyer, 311U.S.457,
463 (1940)). The minimum-contacts requirement focuses on whether "the defendant's suitrelated conduct ... create[s] a substantial connection with the forum State." Walden v. Fiore, 134
S. Ct. 1115, 1121 (2014). Whether the conduct at issue is suit-related depends on "the
relationship among the defendant, the forum, and the litigation," Keeton v. Hustler Magazine,

Inc., 465 U.S. 770, 775 (1984), including the nature of the claim asserted. See Calder v. Jones;
465 U.S.

783~

789-90 (1984).

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Finally, even if a defendant has minimum suit-related contacts with a state, the
defendant may defeat specific personal jurisdiction by sufficiently demonstrating that other
considerations render jurisdiction unreasonable. See Burger King, 471 U.S. at 477. The
Supreme Court has identified a number of factors for courts to consider, including "the burden
on the defendant," "the forum State's interest in adjudicating the dispute," "the plaintiffs
interest in obtaining convenient and effective relief," and "the interstate judicial system's
interest in obtaining the most efficient resolution of controversies." World-Wide Volkswagen

Corporation v. Woodson, 444 U.S. 286, 292 (1980).

IV.

DISCUSSION
PSI moves to dismiss for lack of personal jurisdiction, arguing that there is no basis for

specific or general jurisdiction. (DJ. 7 at 1.) Millennium responds that the court has personal
jurisdiction over Pharmascience Inc. because: (1) Pharmascience Inc. purposefully directed its
activities to a Delaware resident by sending its Paragraph IV Letter to Millennium, a Delaware
corporation (DJ. 13 at 4); (2) Pharmascience Inc. knew or should have known that Millennium
would sue for infringement in Delaware if Pharmascience Inc. filed an ANDA seeking approval
for a generic version ofVELCADE® for Injection (Id at 6); (3) judicial economy weighs in
favor of exercising specific jurisdiction (Id at 8); and (4) if Pharmascience, Inc. is not subject to
personal jurisdiction based on its contacts with Delaware, it is subject to personal jurisdiction
based on Federal Rule of Civil Procedure 4(k)(2), the federal long-arm statute. (Id)
Subsequently, Millennium filed a Notice of Supplemental Authority (DJ. 18) in which it
argued that the March 18, 2016 opinion of the Federal Circuit in Acorda establishes that there is
jurisdiction in this case. Acorda, 817 F.3d 755. In Acorda, the Federal Circuit found that when a
plaintiff files an ANDA the minimum-contacts standard is satisfied. Id The Acorda court

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reasoned that if proven, infringement would concretely injure Acorda and AstraZeneca in the
State by displacing some of their Delaware sales. Id. at 759-60. Millennium argues that based
upon this decision, PSI created personal jurisdiction by filing its ANDA and creating a future
harm to a Delaware corporation sufficient for minimum contacts. (D.I. 18 at 2.)
The Pharmascience Defendants respond that though PSI did file an ANDA, unlike
Mylan, the ANDA is PSI's sole contact with Delaware. (D.I. 19.) PSI points out that in its
analysis, the Federal Circuit pointed to other contacts that Mylan had with Delaware. See, e.g.,

Acorda, 817 F.3d at 762 (" .. .it suffices for Delaware to meet the minimum-contacts requirement
in the present cases that Mylan's ANDA filings and its distribution channels establish that Mylan
plans to market its proposed drugs in Delaware ... "); id. at 763 ("Mylan has registered to do
business in Delaware and appointed an agent to accept service of process there."); id. (Mylan
indicated in its certificate of registration that it intends to engage in "[p]harmaceutical
manufacturing, distribution and sales" in Delaware, and Mylan registered with the Delaware
Board of Pharmacy as a licensed "Pharmacy-Wholesale" and a "Distributor/Manufacturer
CSR.").
PSI claims that it is a Canadian company with a principal place of business in Montreal.
(D.I. 7 at 8.) According to PSI, it prepared the ANDA in Canada, the ANDA was submitted to
the FDA in Maryland, and PSI sent its Paragraph N Letter to Millennium in Massachusetts. (Id.
at 4.) PSI asserts that it is not incorporated in Delaware, is not registered to do business in
Delaware, and it has no employees or agents in Delaware, does not maintain a post office box,
mail drop, telephone number, office, or any place of business in Delaware. (D.I. 19 at 2.) PSI
does not have any bank accounts in Delaware, nor does it file taxes in Delaware. McDiarmid
Deel. ii1f 3, 5. PSI claims that it does not have any distribution channels or an agent to accept

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service of process in Delaware. (D.I. 19 at 2.) PSI asserts that it has only defended itself in one
Delaware litigation, which was unrelated to this case. (Id. at 15.) See In re Bendamustine,
1:2013-cv-02046-GMS. Finally, unlike Mylan, PSI claims it does not have an approved and
active ANDA, does not import any drug products into the United States, and has no sales of any
drug products in the United States, including Delaware. (D.I. 19 at 2.)
Based upon the Acorda decision, the court concludes that there is specific personal
jurisdiction over PSI, even though PSI claims it does not have additional contacts With Delaware
besides the filing of its ANDA. The Acorda court noted that Mylan was incorporated in West
Virginia, prepared its ANDA primarily in West Virginia, and filed its ANDA in
Maryland. Acorda, 817 F.3d at 758. The court also acknowledged that Mylan was registered to
do business in Delaware and AstraZeneca and Acorda are incorporated in Delaware, however,
the holding in the case was not based upon these facts. Id. at 763. Thus, the court must conclude
that specific personal jurisdiction over PSI exists in this case based upon PSI' s ANDA
filing. Delaware is a state where PSI will engage in marketing ifthe ANDA is approved and that
marketing is directly related to this suit. See 21 U.S.C. § 355G)(5)(B). Acorda Therapeutics Inc.

v. Mylan Pharm. Inc., 817 F.3d 755, 760 (Fed. Cir. 2016). See also id. at 761-62 (Fed. Cir.
2016) ("We have noted that Congress deemed the ANDA filing to have a non-speculative causal
connection to the ANDA filer's future infliction of real-world market injury on the patent
holder ... ").
Considerations of fairness do not override the minimum contacts that justify exercising
personal jurisdiction over PSI, particularly given that there are already related ANDA litigations
concerning VELCADE® taking place in this district. (D.I. 7 at 2.) Thus, requiring Millennium
to pursue an infringement action against Pharmascience Inc. outside of Delaware unnecessarily

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wastes judicial resources and could result in an outcome that is inconsistent with decisions issued
in the other ANDA cases relating to VELCADE® and the patents at issue. In addition,
Millennium would be substantially burdened if forced to bring a lawsuit against any ANDA filer
challenging its patent in the location selected by the defendant. See AstraZeneca AB, 72 F.
Supp. 3d 549 at 560. 2
With regard to PSL, however, Millennium fails to demonstrate a basis for general or
specific personal jurisdiction. Thus, PSL must be dismissed as a party to the lawsuit. When a
motion to dismiss for lack of personal jurisdiction under Federal Rules of Civil Procedure
12(b)(2) is brought, the plaintiffs must establish with reasonable particularity "that sufficient
minimum contacts have occurred between the defendant[ s] and the forum state to support
jurisdiction." Reach & Associates, P.C. v. Dencer, 269 F. Supp.2d 497, 502 (D. Del. 2003)
(citing Provident National Bank v. California Federal Savings & Loan Assoc., 819 F.2d 434, 437
(3d Cir. 1987)). Millennium does not allege that PSL filed an ANDA, but rather that it
collaborated with PSI to do so, an assertion that Millennium fails to support with reasonable
particularity. On the other hand, PSL declares that it has no ANDA, it did not participate in the
accused ANDA, and it did not work on the accused ANDA product. See Declaration of Sophie
Tanguay ("Tanguay Deel.") iii! 5, 7-8. Additionally, Millennium fails to assert that PSL has any
physical presence in Delaware or that PSL is incorporated or registered to do business in
Delaware. (D.I. 10 at 1.) PSL has no systematic and continuous contacts by which it is "at
home" in the state. In fact, PSL claims that it does not make or sell any products in the United
States and does not import or distribute any products in this country, for PSI or anyone. (Id.)

2 Having found there is a basis for personal jurisdiction over PSI, the court need not
arguments regarding general jurisdiction.

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addres~

the parties'

There is no personal jurisdiction over PSL because Millennium fails to establish a general or
specific basis for finding such.

V.

CONCLUSION
For the foregoing reasons, the court will deny PSI's motion to dismiss (D.I. 6) and grant

PSL' s motion to dismiss (D .I. 9) for lack of personal jurisdi t ·on.

Dated: June~' 2016

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