ELI LILLY AND COMPANY et al v. NANG KUANG PHARMACEUTICAL CO., LTD. et al

Filing 59

ORDER denying 11 Motion to Dismiss for Lack of Jurisdiction. Signed by Judge Tanya Walton Pratt on 8/24/2015. (CBU)

UNITED STATES DISTRICT COURT
SOUTHERN DISTRICT OF INDIANA
INDIANAPOLIS DIVISION
ELI LILLY AND COMPANY, and
THE TRUSTEES OF PRINCETON
UNIVERSITY,
Plaintiffs,
v.
NANG KUANG PHARMACEUTICAL CO.,
LTD., and CANDA NX-2, LLC,
Defendants.

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Case No. 1:14-cv-01647-TWP-DKL

ENTRY ON MOTION TO DISMISS
This matter is before the Court on a Motion to Dismiss filed by Defendants, Nang Kuang
Pharmaceutical Co., Ltd. (“Nang Kuang”) and CANDA NX-2, LLC (“CANDA”) (collectively,
“Defendants”), pursuant to Federal Rules of Civil Procedure 12(b)(2) and (7) (Filing No. 11).
Defendants assert that this action filed by Plaintiffs, Eli Lilly and Company (“Lilly”) and the
Trustees of Princeton University (collectively, “Plaintiffs”), should be dismissed because the Court
lacks personal jurisdiction over Defendants. For the reasons set forth below, Defendants’ motion
is DENIED.
I.

BACKGROUND

This Hatch-Waxman patent infringement case arises from Nang Kuang’s submission of
Abbreviated New Drug Application No. 207352 (“the ANDA”) to the United States Food & Drug
Administration (“FDA”) requesting approval of Nang Kuang’s generic pemetrexed disodium (“the
ANDA Products”). The ANDA included a Paragraph IV certification that the claims of U.S. Patent
Nos. 5,344,932 (the “‘932 patent”) and 7,772,209 (the “‘209 patent”) are invalid, unenforceable
and/or not infringed by the manufacture, use, importation, sale or offer for sale of the ANDA
Products. The ‘932 patent is owned by the Trustees of Princeton University and exclusively

licensed to Lilly, and covers Lilly’s anti-cancer drug pemetrexed. The ‘209 patent is owned by
Lilly and is directed to methods of administering pemetrexed with folic acid and vitamin B 12. Lilly
sells the patented drug and its associated method of administration under the trade name
ALIMTA®.
Nang Kuang is a Taiwanese generic drug manufacturer seeking approval from the FDA to
market generic versions of ALIMTA®. CANDA, a Texas limited liability company, entered into
an agreement with Nang Kuang whereby Nang Kuang agreed to exclusively manufacture and
supply the ANDA Product to CANDA, and CANDA agreed to assist Nang Kuang with the U.S.
litigation arising from Nang Kuang’s submission of the ANDA, and find marketing partners to
market, sell and distributed the ANDA Product if the ANDA application is approved by the FDA.
As of this date, the FDA has not approved the ANDA, and neither Nang Kuang nor CANDA has
commercially manufactured, used, sold or offered for sale in, or imported into, the United States
any ANDA Product. On August 25, 2014, Nang Kuang and CANDA jointly provided a notice of
certification to the required parties pursuant to 21 C.F.R. § 314.95(a) (“Notice Letter”), including
Lilly’s Indianapolis-based General Counsel and its Indianapolis trial counsel. The submission of
the Notice Letter triggered the forty-five day period in which Lilly had to file the instant HatchWaxman action to challenge the ANDA and seek an order that the effective date of any approval
of Nang Kuang’s ANDA be not earlier than the expiration date of Plaintiffs’ patents.
II.

LEGAL STANDARD

Federal Rule of Civil Procedure 12(b)(2) requires dismissal of a claim where personal
jurisdiction is lacking. When “[a] defendant moves to dismiss the complaint under Federal Rule
of Civil Procedure 12(b)(2) for lack of personal jurisdiction, the plaintiff bears the burden of
demonstrating the existence of jurisdiction.” Purdue Research Found. v. Sanofi–Synthelabo, S.A.,

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338 F.3d 773, 782 (7th Cir. 2003) (citations omitted). When a district court rules on a defendant’s
motion to dismiss based on the submission of written materials, the plaintiff “need only make out
a prima facie case of personal jurisdiction” and “is entitled to the resolution in its favor of all
disputes concerning relevant facts presented in the record.” Id. (internal quotation marks and
citations omitted).
Federal Circuit law governs personal jurisdiction issues in patent infringement cases. See
Hildebrand v. Steck Mfg. Co., 279 F.3d 1351, 1354 (Fed. Cir. 2002). A district court may properly
exercise personal jurisdiction over a non-resident defendant if a two-step analysis is undertaken
and satisfied. First, the party resisting the exercise of jurisdiction must be amenable to service of
process under the state’s long-arm statute; second, the exercise of personal jurisdiction must
comport with the due process clause of the Constitution. Id. Because Indiana’s long-arm statute,
Indiana Rule of Trial Procedure 4.4(A), “expand[s] personal jurisdiction to the full extent
permitted by the Due Process Clause,” LinkAmerica Corp. v. Cox, 857 N.E.2d 961, 966 (Ind.
2006), the sole question before the Court is whether due process would be offended if the Court
were to exercise personal jurisdiction over the Defendants.
III. DISCUSSION
The Court previously provided extensive discussion on the issue of general and specific
jurisdiction in the context of ANDA litigation in its Entry denying Plaintiffs’ motion for
jurisdictional discovery; thus it need not be repeated in detail here. See Filing No. 54. Plaintiffs
argue, inter alia, that this Court has specific jurisdiction over the Defendants. The Federal Circuit
applies a three-prong test to determine if specific jurisdiction exists over a defendant: (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 exercising personal jurisdiction is reasonable

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and fair. Nuance Commc’ns, Inc. v. Abbyy Software House, 626 F.3d 1222, 1231 (Fed. Cir. 2010).
In Hatch-Waxman infringement cases decided since the Supreme Court’s decision in Daimler AG
v. Bauman, 134 S.Ct. 746 (2014), district courts have consistently found that these requirements
for the exercise of personal jurisdiction over defendants filing ANDAs are satisfied.
Defendants improperly focus on the act of completing the ANDA and the possible future
distribution of the ANDA Product as the basis for the Court’s jurisdictional analysis, arguing that
neither of these acts occurred in or are directed toward Indiana. However, what is relevant is the
fact that Defendants sent the Notice Letter to Plaintiffs in Indiana, and the Court agrees with
Plaintiffs and other courts that this is sufficient to establish specific jurisdiction over the
Defendants. See Eli Lilly & Co. v. Mylan Pharm., Inc., No. 1:14-CV-00389-SEB-TA, 2015 WL
1125032, at *6 (S.D. Ind. Mar. 12, 2015) (“Defendants purposefully directed their activities at
Indiana by sending a Paragraph IV certification notice letter to Lilly in Indiana, which act they
knew would trigger the forty-five-day period within which Plaintiffs were empowered to file suit
under the Hatch–Waxman framework.”); AstraZeneca AB v. Mylan Pharm., Inc., 72 F. Supp. 3d
549, 559 (D. Del. 2014) motion to certify appeal granted sub nom. Astrazeneca AB v. Aurobindo
Pharma Ltd., No. CV 14-664-GMS, 2014 WL 7533913 (D. Del. Dec. 17, 2014) (“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.”)
Likewise, in this case, Defendants’ actions in filing the ANDA and sending the Notice
Letter was the act that gave rise to this action in this district. The Defendants’ actions were
purposefully directed toward a resident of this forum—Lilly—and the instant claim arises out of
those activities, as it is Lilly that was required to file this action to protect its intellectual property
rights, and it is Lilly that would be injured if Defendants’ ANDA Products infringe on the

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Plaintiffs’ patents. Because Lilly’s state of incorporation is Indiana, the Court considers Indiana
to be the place of the injury that Plaintiffs allege arose by the filing of the ANDA. See Acorda
Therapeutics, Inc. v. Mylan Pharm. Inc., 78 F. Supp. 3d 572 (D. Del. 2015) (“[I]t seems logical to
conclude that the state of incorporation is at least one place in which a corporation whose patents
are artificially infringed by an ANDA filing is injured.”). Accordingly, the Court concludes that
the Defendants’ act of filing an ANDA and directing a Paragraph IV certification to Indiana
provide sufficient minimum contacts with this district to satisfy the requirements of an exercise of
specific jurisdiction over Nang Kuang and CANDA.1
IV. CONCLUSION
For the reasons set forth above, the Court finds that it has personal jurisdiction over
Defendants Nang Kuang and CANDA based upon their actions directed toward Plaintiff Lilly in
Indiana. Therefore, Defendants’ Motion to Dismiss (Filing No. 11) is DENIED.
SO ORDERED.
Date: 8/24/2015
DISTRIBUTION:
Jan M. Carroll
BARNES & THORNBURG LLP
[e-mail]
Aya Cieslak-Tochigi
FARNEY DANIELS PC
[e-mail]
Steven R. Daniels
FARNEY DANIELS PC
[e-mail]
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Because the Court finds that there is sufficient basis for the exercise of specific jurisdiction over Defendants, there
is no need to address the parties’ arguments regarding general jurisdiction or jurisdiction arising under Federal Rule
of Civil Procedure 4(k)(2). Likewise, Defendants’ arguments for dismissal under Rule 12(b)(7) are moot.

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Michael A. Siem
FARNEY DANIELS, PC
[e-mail]
Anthony R. Jost
RILEY BENNETT & EGLOFF LLP
[e-mail]
Stephanie Snell Chaudhary
RILEY BENNETT & EGLOFF LLP
[e-mail]
Andrew V. Trask
WILLIAMS & CONNOLLY
[e-mail]
Adam L. Perlman
WILLIAMS & CONNOLLY LLP
[e-mail]
Bruce Roger Genderson
WILLIAMS & CONNOLLY LLP
[e-mail]
David M. Krinsky
WILLIAMS & CONNOLLY, LLP
[e-mail]
Dov P. Grossman
WILLIAMS & CONNOLLY, LLP
[e-mail]
Ellen E. Oberwetter
WILLIAMS & CONNOLLY, LLP
[e-mail]

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