Case 1:14-cv-01104-RGA Document 61 Filed 08/07/15 Page 1 of 15 PageID #: 936
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`IN THE UNITED STATES DISTRICT COURT
`
`FOR THE DISTRICT OF DELA WARE
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`NOVARTIS PHARMACEUTICALS
`CORPORATION, NOVARTIS AG,
`NOVARTIS PHARMA AG, and LTS
`LOHMANN THERAPIE-SYSTEME AG,
`
`Plaintiffs.
`
`C.A. No. 14-cv-1104-RGA
`
`v.
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`ZYDUS NOVELTECH INC.,
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`Defendant.
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`Memorandum Opinion
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`Daniel Silver, Esq., McCarter & English LLP, Wilmington, DE; Nicholas Kallas, Esq.,
`Fitzpatrick, Cella, Harper & Scinto, New York, NY; Christopher Loh, Esq. (argued), Fitzpatrick,
`Cella, Harper & Scinto, New York, NY; attorneys for the Plaintiffs.
`
`Ryan Newell, Esq., Connolly Gallagher LLP, Wilmington, DE; Charles Weiss, Esq. (argued),
`Holland & Knight; New York, NY; John Evans, Esq., Holland & Knight, Judith Nemsick, Esq.,
`Holland & Knight, New York, NY; attorneys for the Defendants.
`
`August 7, 2015
`
`I
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`

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`Case 1:14-cv-01104-RGA Document 61 Filed 08/07/15 Page 2 of 15 PageID #: 937
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`Plaintiffs filed a Hatch-Waxman patent infringement action against defendants Zydus
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`Noveltech, Inc., Zydus Pharmaecuticals (USA) Inc., and Cadila Healthcare Ltd. for infringing
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`two patents for the "Exelon" transdermal system, which is used to treat dementia. (D.I. 15 at 6;
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`D.I. 28 at p. 1; D.I. 1 at 4-6). Immediately after filing this case, Plaintiffs filed a parallel action
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`in the District of New Jersey. (D.I. 15 at 6).
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`From 2011 to the present, this Court has resolved, or will resolve, a number of Exelon-
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`related ANDA suits filed by Plaintiffs against other defendants. (No. 11-1077-RGA, D.I. 426;
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`No. 11-1112-RGA, D.I. 40; No. 13-52-RGA, D.I. 177, 178; No. 13-527-RGA; No. 14-777-
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`RGA). Novartis Pharmaceuticals Corporation is incorporated in Delaware and researches,
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`markets, and sells prescription drugs. (D.I. 28 at p. 2; D.I. 29 at 1). Novartis AG and Novartis
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`Pharma AG are Swiss companies with a principal place of business in Basel, Switzerland. (D.I.
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`28 at p. 2). LTS Lohmann Therapie-Systeme AG is a German company with its principal place
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`of business in Germany. (D.I. 28 at p. 2).
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`Defendants have moved to dismiss the complaint for lack of personal jurisdiction. (D.I.
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`15). Defendants Zydus Pharmaceuticals and Cadila also moved to dismiss the complaint for
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`failure to state a claim under Federal Rule of Civil Procedure 12(b )(2), and Cadila moved to
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`dismiss for insufficient service of process under Rule 12(b)(5). (D.I. 15 at 6). The Court granted
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`a stipulation to dismiss the complaint against defendants Zydus Pharmaceuticals and Cadila.
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`(D.I. 24, 22). 1 The remaining defendant is Zydus Noveltech. Therefore, ~he only remaining
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`1 The stipulation included, inter alia, an agreement that Zydus Pharmaceuticals and Cadila would
`provide discovery as if they were parties and that these two defendants consent to jurisdiction
`only to enforce the stipulation, and nothing more. (D.I. 22 at 2-3).
`
`2
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`

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`Case 1:14-cv-01104-RGA Document 61 Filed 08/07/15 Page 3 of 15 PageID #: 938
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`issue for this Court is whether there is personal jurisdiction over Defendant Zydus Noveltech.
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`(See D.I. 28 at p. l n. 1 ).
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`Zydus Noveltech is a New Jersey corporation with a principal place of business in
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`Vermont. (D.I. 18 at 1; see also D.I. 47 at 6). Zydus Pharmaceuticals and Zydus Noveltech are
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`sister companies, and Cadila is their ultimate parent company. 2 (D.I. 33 at 6). The majority
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`shareholder of Zydus Noveltech is Zydus International Private Ltd., a subsidiary of Cadila. (D.I.
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`18 at 2). Zydus Noveltech has no property, personnel, or offices in Delaware, does not sell any
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`products in Delaware, and does not conduct any business in Delaware. (D.I. 18 at I). Zydus
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`Noveltech is not registered to do business in Delaware. (D.I. 47 at 13). Zydus Noveltech
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`prepared and submitted the ANDA, but no work to prepare the product or ANDA was conducted
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`in Delaware. (D.I. 18 at 2). Defendant sent its ANDA notice letter on July 16, 2014 to Plaintiffs
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`in Switzerland, Germany, and New Jersey. (D.I. 34-1 at 2-3). This is the first ANDA case that
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`Defendant has been involved in, although its sister company Zydus Pharmaceuticals has
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`appeared before this Court. (D.1. 47 at 6).
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`There is a dispute among the parties about whether Defendant's generic drug at issue will
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`make it to market in Delaware. Plaintiffs argue that Defendant will sell generic copies of the
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`Exelon product in Delaware, through its sister company Zydus Pharmaceuticals (D.I. 28 at pp. 3-
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`2 According to Defendant, Zydus Noveltech focuses primarily on transdermal drug products,
`such as the technology at issue in this case, while Zydus Pharmaceuticals sells oral products.
`(D.I. 33 at 6). Defendant explains: "While the two companies share the same ultimate parent
`corporation (Cadila), Zydus Pharmaceuticals has no connection to the generic rivastigmine patch
`at issue in this case and Novartis has no basis for asserting that Zydus Pharmaceuticals will
`eventually sell Zydus Noveltech's generic rivastigmine patch (assuming approval by the FDA)."
`(D.I. 33 at 6).
`
`3
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`

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`Case 1:14-cv-01104-RGA Document 61 Filed 08/07/15 Page 4 of 15 PageID #: 939
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`8), though Defendant calls these allegations "mere speculation."3 (D.I. 33 at 6). Defendant
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`questions the proposition that it will sell products in Delaware in the future: "Novartis has no
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`evidence that Zydus Noveltech will sell products in Delaware in the future; there is no
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`contractual obligation or other evidence to support Novartis's argument." (D.I. 33 at 12).
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`I.
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`LEGAL STANDARD
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`Under Federal Rule of Civil Procedure 12(b )(2), a party may move to dismiss a case
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`because the court lacks personal jurisdiction over that party. "Once challenged, the plaintiff
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`bears the burden of establishing personal jurisdiction." 0 'Connor v. Sandy Lane Hotel Co., 496
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`F.3d 312, 316 (3d Cir. 2007). Absent an evidentiary hearing, a plaintiff needs only to establish a
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`prima facie case of personal jurisdiction, and the plaintiff is entitled to have its allegations taken
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`as true and factual disputes drawn in its favor. Id.
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`Personal jurisdiction derives from two sources, statutory and constitutional law. A
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`district court must determine whether the state's long-arm statute permits service of process, and
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`whether asserting personal jurisdiction would violate due process. See !named Corp. v. Kuzmak,
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`249 F.3d 1356, 1359 (Fed. Cir. 2001). When determining whether a district court properly
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`decided personal jurisdiction, the Federal Circuit applies its own law, not regional circuit law,
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`because the jurisdictional issue is "intimately involved with the substance of the patent laws."
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`Id (citations omitted) (internal quotation marks omitted). Delaware's long-arm statute has been
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`construed "broadly to confer jurisdiction to the maximum extent possible under the Due Process
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`3 Plaintiffs' position on the role of the sister company Zydus Pharmaceuticals seems incorrect. It
`seems clear that Zydus Pharmaceuticals has no involvement with the rivastigmine product, and
`because it focuses only on oral drugs, likely would not be involved in the future. (D.I. 33 at 6
`(citing D.I. 18 at if 8)). By what means Zydus Noveltech would sell the product in Delaware in
`the future seems to be an open question.
`
`4
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`

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`Case 1:14-cv-01104-RGA Document 61 Filed 08/07/15 Page 5 of 15 PageID #: 940
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`Clause, so the focus of the inquiry traditionally rests on the constitutional component."
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`AstraZeneca AB v. Mylan, 2014 WL 5778016, at *2 (D. Del. Nov. 5, 2014) (internal quotation
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`marks omitted) (citations omitted).4
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`Due process requires "minimum contacts" between an out-of-state defendant and the
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`forum "such that maintenance of the suit does not offend traditional notions of fair play and
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`substantial justice." Int'! Shoe Co. v. State of Wash., Office of Unemployment Comp. &
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`Placement, 326 U.S. 310, 316 (1945) (internal quotation marks omitted) (internal citations
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`omitted). General jurisdiction occurs where a defendant's contacts with a state are "so
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`continuous and systematic as to render it essentially at home in the forum State." Daimler AG v.
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`Bauman, 134 S. Ct. 746, 761 (2014) (internal quotation marks omitted). Specific jurisdiction
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`occurs when a defendant has "purposefully directed his activities at residents of the forum, and
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`the litigation results from alleged injuries that arise out of or relate to those activities." Burger
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`King Corp. v. Rudzewicz, 471 U.S. 462, 472 (1985) (internal citations omitted) (internal
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`quotation marks omitted).
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`The Supreme Court has recently explained that "specific jurisdiction has become the
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`centerpiece of modem jurisdiction theory, while general jurisdiction has played a reduced role."
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`Daimler AG v. Bauman, 134 S. Ct. 746, 755 (2014) (internal quotation marks omitted). The
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`Supreme Court has stressed the difference between the specific and general jurisdiction inquiries.
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`See Daimler AG, 134 S. Ct. at 757 ("Although the placement of a product into the stream of
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`4 This Court tends to agree with Judge Sleet that it is not entirely clear whether Delaware's long(cid:173)
`arm statute extends as far as allowed by the constitutional component. See AstraZeneca, 2014
`WL 5778016, at *2 n. 1; see also Commissariat A L'Energie Atomique v. Chi Mei
`Optoelectronics Corp., 395 F.3d 1315, 1322 (Fed. Cir. 2005) ("Delaware law is also unclear as
`to whether or not the long arm statute is coextensive with the due process clause."). As in
`AstraZeneca, because the parties have not challenged the limits of Delaware's long-arm statute,
`this Court will focus the inquiry on the constitutional analysis.
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`5
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`

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`Case 1:14-cv-01104-RGA Document 61 Filed 08/07/15 Page 6 of 15 PageID #: 941
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`commerce may bolster an affiliation germane to specific jurisdiction, we explained, such
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`contacts do not warrant a determination that, based on those ties, the forum has general
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`jurisdiction over a defendant. As International Shoe itself teaches, a corporation's continuous
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`activity of some sorts within a state is not enough to support the demand that the corporation be
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`amenable to suits unrelated to that activity." (internal quotation marks omitted) (citations
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`omitted)).
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`II.
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`DISCUSSION
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`In recent proceedings, the judges in this District have grappled with personal jurisdiction
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`for ANDA suits with similar, albeit not identical, fact patterns.5 While I expect there will soon
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`be guidance from the Federal Circuit on this issue, 6 I believe careful recitation of the facts and
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`analysis of the cases on appeal is instructive to the present matter. 7
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`In AstraZeneca AB v. Mylan Pharmaceuticals, 2014 WL 5778016, at *7 (D. Del. Nov. 5,
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`2014), Judge Sleet found that the act of filing an ANDA and a paragraph IV notification
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`provided sufficient minimum contacts with Delaware for specific jurisdiction, denying a motion
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`5 In Novartis Pharmaceuticals Corp. v. Mylan Inc., 2015 WL 1246285, at *3-5 (D. Del. March
`16, 2015), I explicitly adopted Judge Stark's reasoning in Acorda Therapeutics, Inc. v. Mylan
`Pharmaceuticals Inc., 2015 WL 186833 (D. Del. Jan. 14, 2015), finding that Defendant Mylan
`Pharmaceuticals consented to general jurisdiction by complying with Delaware registration
`statutes. I also permitted jurisdictional discovery to determine if there was specific jurisdiction
`over Mylan Inc.
`While AstraZeneca and Acorda may differ in their analysis with respect to consent and
`general jurisdiction, they are consistent in their analysis on specific jurisdiction. Only specific
`jurisdiction is at issue in the present matter.
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`6 Both AstraZeneca and Acorda are on interlocutory appeal. (Nos. 15-1460, 15-1456).
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`7 As I was preparing to file this Memorandum Opinion and Order, Judge Robinson issued
`Purdue Pharma L.P. v. Collegium Pharma., Inc., Civ. No. 15-260-SLR, D.I. 29 (D. Del. August
`6, 2015), which has analogous facts and reaches the same conclusion.
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`6
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`

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`Case 1:14-cv-01104-RGA Document 61 Filed 08/07/15 Page 7 of 15 PageID #: 942
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`to dismiss for lack of personal jurisdiction. In that case, Plaintiff AstraZeneca AB was a
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`Swedish company with its principal place of business in Sweden, and its U.S. subsidiary,
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`AstraZeneca Pharmaceuticals LP was a limited partnership operating under the laws of Delaware
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`with its principal place of business in Delaware. Id at * 1. Plaintiff filed a patent infringement
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`suit in the District of Delaware triggered by two AND As filed by Defendant, Mylan, which was
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`incorporated in West Virginia with its principal place of business also in West Virginia. Id at
`* 1. Mylan had no property or employees in Delaware; however, it was registered to do business
`in Delaware and had appointed a registered agent to accept process in Delaware. Id at * 1. The
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`AND As at issue were prepared in West Virginia and filed in Maryland with the FDA. Id at *I.
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`Mylan sent its paragraph IV certification to AstraZeneca U.S. in the state of Delaware. Id at *7.
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`Mylan had previously litigated in the District of Delaware numerous times. Id at * 1. Judge
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`Sleet found that there was no general jurisdiction over Mylan because Plaintiff failed to allege
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`facts that Mylan was "essentially at home" in Delaware. Id at *3-4. Judge Sleet also found that
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`Mylan' s compliance with Delaware registration statutes to do business in the state did not
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`constitute consent to general jurisdiction. Judge Sleet, however, found that the act of filing an
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`ANDA and the paragraph IV letter mailed to Delaware provided minimum contacts with
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`Delaware to support specific jurisdiction. Id at *7. Judge Sleet's specific jurisdiction analysis
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`relied in part on the uniqueness of the Hatch-Waxman Act, which makes patent litigation
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`expected as part of the FDA approval process for generic drugs. Id at *6. Therefore, Plaintiff's
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`cause of action was triggered by Mylan's artificial injury against Plaintiff in Delaware. Id at *7.
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`In Acorda Therapeutics, Inc. v. Mylan Pharmaceuticals Inc., 2015 WL 186833, at *7-19
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`(D. Del. Jan. 14, 2015), Judge Stark determined that there was personal jurisdiction in an ANDA
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`case against one defendant because it had consented to personal jurisdiction and because there
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`7
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`

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`Case 1:14-cv-01104-RGA Document 61 Filed 08/07/15 Page 8 of 15 PageID #: 943
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`was specific jurisdiction. Plaintiff Acorda was a Delaware corporation with a principal place of
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`business in the state of New York. Id. at *1. Plaintiff Alkermes was an Ireland corporation with
`a principal place of business also in Ireland. Id. at * 1. Defendant Mylan Pharma was a West
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`Virginia corporation with a principal place of business also in West Virginia. Id. at *2. Mylan
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`Pharma was registered to do business in Delaware, had a registered agent to accept process in
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`Delaware, and had litigated extensively in the District. Id at *2. Mylan Pharma was a
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`subsidiary of Mylan Inc., a Pennsylvania corporation with a principal place of business in
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`Pennsylvania. Id at *3. Mylan Inc. was not registered to do business in Delaware, though it has
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`litigated in the District. Id at *3. Neither Mylan Pharma nor Mylan Inc. had offices or property
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`in Delaware. Id. at *3. Mylan Pharma prepared its ANDA filing in West Virginia and sent its
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`ANDA notice letter to plaintiffs in New York and Ireland. Judge Stark determined both
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`defendants were not "at home" in Delaware, meaning there could be no general jurisdiction on
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`that ground. Id. at *7. Judge Stark, however, did determine that the court could exercise general
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`jurisdiction over Mylan Pharma because it consented to such jurisdiction when it complied with
`Delaware registration laws and appointed an agent to accept service of process. Id. at * 11.
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`Judge Stark found that this consent to general jurisdiction did not extend to Mylan Inc. even
`though Mylan Pharma was its wholly-owned subsidiary. Id at * 15.
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`Judge Stark determined that there was specific jurisdiction over Mylan Pharma because it
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`directed activities to Delaware, including sending a notice letter to a Delaware corporation,
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`which had already initiated litigation against others to enforce its patents, something Defendant
`knew or should have known. Id at * 16. Judge Stark found that Mylan Pharma had also directed
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`activities toward Delaware such as registering to do business in the state, appointing a registered
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`agent to accept process, and had been a frequent litigant, particularly in ANDA litigation. Id at
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`8
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`

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`Case 1:14-cv-01104-RGA Document 61 Filed 08/07/15 Page 9 of 15 PageID #: 944
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`*16. Comparing the facts with Judge Sleet's decision in AstraZeneca, Judge Stark determined
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`that the absence of mailing a paragraph IV certification into Delaware did not eliminate the
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`possibility of exercising specific jurisdiction. Id at * 18. Judge Stark recognized that Plaintiff,
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`as a Delaware corporate citizen, felt an injury when its patents were artificially infringed by an
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`ANDA filing in Delaware. Id. at *18. Because Mylan Inc. was not registered to do business in
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`Delaware, and was not involved in the ANDA filing, Judge Stark determined that those facts
`were not sufficient to establish specific jurisdiction. Id at * 19-20. However, Judge Stark did
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`permit jurisdictional discovery to determine whether the agency relationship between Mylan Inc.
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`and Mylan Pharma allows the Court to exercise personal jurisdiction over Mylan Inc. Id
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`A. General Jurisdiction
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`This Court cannot exercise general jurisdiction over Zydus Noveltech because it is not
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`"essentially at home" in Delaware. See Daimler AG, 134 S. Ct. at 761. Zydus Noveltech is not a
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`Delaware corporation and this state is not its principal place of business. It has no property, staff
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`or offices in the state and does not conduct any business here. Defendant has not registered to do
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`business in Delaware, and thus no consent to general jurisdiction similar to that in Acorda can be
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`found. No work related to preparing the ANDA or product was conducted in the state. The only
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`fact ofrelevance is that Defendant directed an ANDA notice letter at Plaintiffs, which is not
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`relevant for the general jurisdiction inquiry. Plaintiffs do not dispute the lack of general
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`jurisdiction. Their briefing only addresses specific jurisdiction. Therefore, there is no general
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`jurisdiction over Zydus Noveltech because there are no facts that demonstrate that Defendant is
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`essentially at home here. 8
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`8 This result is consistent with the positions recently taken in similar cases by this District, where
`no general jurisdiction was found. See Acorda, 2015 WL 186833, at *7; AstraZeneca AB, 2014
`WL 5778016, at *4; Novartis v. Mylan, 2015 WL 1246285, at *7. While consent to general
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`9
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`

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`Case 1:14-cv-01104-RGA Document 61 Filed 08/07/15 Page 10 of 15 PageID #: 945
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`B. Specific Jurisdiction
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`In essence, Plaintiffs argue that there is specific jurisdiction over Zydus Noveltech for
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`two reasons: first, Zydus Noveltech directed its notice of ANDA filing to Novartis
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`Pharmaceuticals, a Delaware corporation; and second, Zydus Noveltech will eventually, if
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`authorized by the FDA, sell its generic product in Delaware. (D.I. 28 at p. 8).
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`Comparing the present matter with Acorda and AstraZeneca, Plaintiffs argue that
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`Defendants directed harm into Delaware and should have reasonably anticipated suit. (D.I. 28 at
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`p. 9). Plaintiffs argue that Novartis Pharmaceuticals, as a Delaware corporation, suffers injury
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`from the filing of the ANDA. (D.I. 28 at p. 10). Because Novartis had already filed nine
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`lawsuits against five groups of generic drug companies to enforce these patents in the District of
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`Delaware, Zydus Noveltech knew or should have known that it would have been sued in
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`Delaware. (D.I. 28 at pp. 10-11). Defendant responds that Plaintiffs' position would result in
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`personal jurisdiction for an ANDA defendant where the plaintiff is incorporated, no matter how
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`limited contacts are to the forum state. (D.I. 33 at 7). Defendant also argues that Plaintiffs are
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`not injured in Delaware, because, if Plaintiffs are injured, the location of such an injury would be ·
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`where the ANDA was prepared and submitted, or Vermont. (D.I. 33 at 7-8). Defendant argues
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`that sending a notice letter to Novartis Pharmaceuticals, a Delaware corporation, at its offices in
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`New Jersey is not sufficient to establish jurisdiction in Delaware. (D.I. 33 at 9-10). Finally,
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`Defendants argue that any arguments about judicial efficiency cannot be used to establish
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`jurisdiction when there is a complete lack of minimum contacts by Defendant. (D.I. 33 at 10-
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`11 ).
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`jurisdiction was found in Acorda, 2015 WL 186833, at *11 and Forest Labs., Inc. v. Amneal
`Pharm. LLC, 2015 WL 880599, at* 15 (D. Del. Feb. 26, 2015), that line of analysis is not
`applicable here because Zydus Noveltech has not registered to do business in Delaware.
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`10
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`

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`Case 1:14-cv-01104-RGA Document 61 Filed 08/07/15 Page 11 of 15 PageID #: 946
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`Next, Plaintiffs argue that once Defendant's ANDA is approved it will sell generic
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`Exelon products in Delaware or direct them to Delaware. (D.I. 28 at p. 13-15). Plaintiffs note
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`that in non-ANDA cases an accused infringer is subject to suit wherever its products are sold,
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`and absent that same result, an ANDA filer would be "insulated" from suit while it filed an
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`infringing ANDA. (D.I. 28 at p. 16). Finally, Plaintiffs argue that an agency theory of personal
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`jurisdiction, which attributes the activities of Zydus Noveltech's affiliates to it, is appropriate.
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`(D.I. 28 at pp. 19-20).
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`Defendant argues that Plaintiffs' theory that there is jurisdiction based on futures sales
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`should fail. (D.I. 33 at 11). Defendant argues that the nature of ANDA litigation means there
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`will never be an infringing sale in Delaware because if this Court finds infringement it will order
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`the FDA not to approve the ANDA until the valid patents expire; likewise, if the Court finds no
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`infringement, then any future sales in Delaware will be noninfringing. (D.I. 33 at 12). It is
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`speculative that Defendant will sell infringing products because Plaintiffs have offered no
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`evidence that Defendant will sell products in Delaware. (D.I. 33 at 12). Finally, Defendants
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`argue that there is no basis for jurisdiction from affiliates such as Zydus Pharmaceuticals because
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`the two companies do not operate in concert with one another or have any agreements with each
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`other over this technology. (D.I. 33 at 9).
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`Defendant's activities have not been purposefully directed at Delaware such that this
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`Court can exercise specific jurisdiction over it. See Burger King Corp. v. Rudzewicz, 471 U.S.
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`462, 472 (1985). Zydus Noveltech has not registered to do business in Delaware, and does not
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`have an agent to accept process in the state. Zydus Noveltech has not previously litigated in
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`Delaware at all-let alone in the ANDA context. Defendant probably anticipated being sued in
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`Delaware, as Plaintiffs had already brought multiple cases involving the same patents in
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`11
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`

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`Case 1:14-cv-01104-RGA Document 61 Filed 08/07/15 Page 12 of 15 PageID #: 947
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`Delaware, but Defendant's anticipation is not by itself significant for the specific jurisdiction
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`analysis. 9 See Novartis, 2015 WL 1246285, at *3 n. 6. Defendant has no property, staff or
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`offices in the state and does not conduct any business here. No work related to preparing the
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`ANDA or product was conducted in this District.
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`At this time, there is no support for the argument that Defendant will sell infringing
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`products in Delaware-and that idea appears to be only attorney argument. There are no facts to
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`even suggest that Defendant will sell or direct its products to Delaware, and at this time, such an
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`argument is entirely speculative for a specific jurisdiction analysis.
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`Unlike AstraZeneca and Acorda, the only fact that provides a jurisdictional hook here is
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`that Defendant directed an ANDA notice to Plaintiffs, albeit to Plaintiffs in Switzerland,
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`Germany, and New Jersey-not Delaware. In AstraZeneca, Judge Sleet found that sending a
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`letter to Delaware was directing activities to Delaware; Judge Stark in Acorda determined that
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`not sending the ANDA notice letter to Delaware did not foreclose a specific jurisdiction analysis.
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`This Court believes those positions are reconcilable; where the ANDA letter is sent by itself is
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`not determinative, but it is an additional fact demonstrating activity relevant to establishing
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`personal jurisdiction.
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`Specific jurisdiction cannot be exercised merely because an ANDA notice letter was sent
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`to a Delaware corporation, in another state, because to do so would offend traditional notions of
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`fair play and substantial justice. A Delaware plaintiffs contacts-its injury-with Delaware
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`may be relevant to the specific jurisdiction inquiry. Acorda, 2015 WL 186833, at* 18. Personal
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`jurisdiction, however, cannot be governed solely by a plaintiffs conduct. See, e.g., Walden v.
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`9 While true that Defendant's sister company Zydus Pharmaceuticals has appeared before this
`Court in ANDA litigation, it is too tenuous for this Court to import that history onto Defendant
`absent additional facts. (D.I. 47 at 6).
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`12
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`

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`Case 1:14-cv-01104-RGA Document 61 Filed 08/07/15 Page 13 of 15 PageID #: 948
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`Fiore, 134 S. Ct. 1115, 1122 (2014) (internal citations omitted) (internal quotation marks
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`omitted). (" .... the relationship must arise out of contacts that the 'defendant himself' creates
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`with the forum State. Due process limits on the State's adjudicative authority principally protect
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`the liberty of the nonresident defendant-not the convenience of plaintiffs or third parties. We
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`have consistently rejected attempts to satisfy the defendant-focused 'minimum contacts' inquiry
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`by demonstrating contacts between the plaintiff (or third parties) and the forum State."); see also
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`Beverly Hills Fan Co. v. Royal Sovereign Corp., 21F.3d1558, 1571 (Fed. Cir. 1994)
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`(" ... analysis oflong-armjurisdiction has its focus on the conduct of the defendant. Plaintiffs
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`contacts with the forum-such as where the plaintiff resides-as a general proposition are not
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`considered a determinative consideration."). Instead, the inquiry must focus on Defendant's
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`conduct and contacts with the forum. To allow jurisdiction in the present matter would not be
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`consistent with the doctrine of specific jurisdiction. It would subject a defendant in an ANDA
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`suit to personal jurisdiction anywhere a plaintiff is incorporated, regardless of the Defendant's
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`activities and contacts with that forum. Such an outcome would offend traditional notions of fair
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`play and substantial justice.
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`Even though Plaintiffs have been injured, it does not follow that the location of that
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`injury is in Delaware merely because an ANDA notice letter was sent elsewhere, to a company
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`incorporated here. Both Judge Sleet in AstraZeneca and Judge Stark in Acorda found in part that
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`specific jurisdiction was proper because an ANDA letter triggered an artificial injury against a
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`plaintiff in Delaware. AstraZeneca, 2014 WL 5778016, at *7; Acorda, 2015 WL 186833, at *18.
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`In Judge Stark's case he determined that specific jurisdiction was proper even though an ANDA
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`letter was sent to a Delaware corporation in another jurisdiction, considering additional activities
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`directed at the state, none of which exist in the present matter. There is no question that
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`13
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`Case 1:14-cv-01104-RGA Document 61 Filed 08/07/15 Page 14 of 15 PageID #: 949
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`infringement in ANDA cases under §271 ( e )(2) is a "highly artificial act of infringement," which
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`allows a patent owner to initiate a lawsuit within 45 days to prevent approval for 30 months (or
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`until a court determines that the patent is not infringed, if that occurs before the 3 0 months has
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`passed). See Eli Lilly & Co. v. Medtronic, Inc., 496 U.S. 661, 677-78 (1990); see also Zeneca v.
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`Mylan Pharmaceuticals, 173 F. 3d 828 at 832-33 (Fed. Cir. 1999); see also AstraZeneca, 2014
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`WL 5778016, at *6 ("ANDA litigation is unlike other patent infringement litigation: The injury
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`is abstract, making it difficult to point to a location out of which the injury 'arises' for
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`jurisdictional purposes. At the same time, defending against an infringement lawsuit is an
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`inherent and expected part of the ANDA filer's business. To put it simply: a lawsuit is often
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`inevitable, but it is not clear where it should be held."). It is beyond dispute that the ANDA
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`process triggered an injury, and that the submission of the ANDA letter triggered an injury
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`against Plaintiff. Io It does not follow that that injury should be where the Plaintiff is
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`incorporated, Delaware, rather than where the letter was directed, New Jersey. 11 Defendant
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`directed activity to New Jersey, not Delaware. A Plaintiff cannot then transport that activity to
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`its place of incorporation. The ANDA process may be unique in how it triggers injury in the
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`10 There has been some dispute among district courts about where the situs of injury is with an
`ANDA filing, whether it is where it was prepared or the generic drugs tests occurred, or whether
`the relevant location is to where the ANDA and notice letter are sent. See AstraZeneca, 2014
`WL 5778016, at *7 n. 3. In the present case, either inquiry demonstrates the injury did not occur
`in Delaware; the ANDA was not prepared in Delaware and the paragraph IV notification was not
`directed to Delaware.
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`II In AstraZeneca, Judge Sleet suggested that the defendant's position that Delaware, where the
`ANDA notice letter was sent, did not have personal jurisdiction implied that under such a theory
`there could be no appropriate location for jurisdiction. 2014 WL 5778016, at *7. Judge Sleet,
`therefore, found that the only appropriate forum was the residence of the patent holder. In the
`present matter, however, because the letter was sent to New Jersey, and not Delaware, such an
`argument would not be relevant.
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`14
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`Case 1:14-cv-01104-RGA Document 61 Filed 08/07/15 Page 15 of 15 PageID #: 950
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`patent context, but it must be subject to the same rules that govern personal jurisdiction. Even
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`though the act of filing the ANDA and the paragraph IV notification constitute an injury, 12
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`neither was directed at Delaware because Defendant sent its letter to Plaintiffs abroad and in
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`New Jersey. Therefore, this Court cannot exercise specific personal jurisdiction over
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`Defendant. 13
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`III. CONCLUSION
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`For the above reasons, Defendants' Motion to Dismiss (D.I. 14) is granted. 14 An
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`appropriate order will follow.
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`12 Both parties have cited to authority on issues that are similar, but not entirely on point. For
`example, the Federal Circuit in Zeneca determined that Maryland, the location of the government
`agency that received AND As, could not exercise personal jurisdiction over a party. 173 F.3d at
`832. But that analysis was based at least in part on the government contacts exception, where
`petitioning the national government does not count as jurisdictional conduct. Id at 831-32.
`Here, where the central jurisdictional fact is the filing of the ANDA notice letter to Plaintiffs, not
`filing the ANDA with the government, that case does not provide much guidance.
`Similarly, Defendants cite to Campbell Pet Co. v. Miale, 542 F. 3d 879, 885-86 (Fed. Cir.
`2008) where the Federal Circuit explained that in the declaratory judgment context, merely
`sending an infringement letter, without more, is an insufficient basis to exercise personal
`jurisdiction. It is hard to draw much from this in the context of the Hatch-Waxman Act, a very
`specific and unique statutory scheme.
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`13 Plaintiffs request jurisdictional discovery if "the Court is inclined to grant [Defendant's]
`motion." (D.I. 28 at p. 4 n. 4). Defendant objects, suggesting such discovery would be futile.
`(D.I. 33 at 14). There is nothing in the record that suggests jurisdictional discovery would
`establish a relationship between Zydus Noveltech and Zydus Pharmaecuticals such that there
`would be specific jurisdiction over Zydus Noveltech. Thus, the proposed discovery would be
`futile. See Toys R Us, Inc. v. Step Two, S.A., 318 F.3d 446, 456 (3d Cir. 2003).
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`14 The result of cases like this one could be significant inefficiency and waste of judicial
`resources because ANDA litigation often involves many generic filers.
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`15