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AstraZeneca Ab v. Mylan Pharmaceuticals, Inc.

United States District Court, D. Delaware

November 5, 2014


Page 550

Michael P. Kelly, Esquire, and Daniel M. Silver, Esquire, McCarter & English, LLP, counsel for plaintiff. Of 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 Joshua Mack, Esquire, and Douglas H. Carsten, Esquire, Wilson Sonsini Goodrich & Rosati.


Page 551

Gregory M. Sleet, United States District Judge.


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 Drag Applications (" ANDA" ) Nos. 205980 and 205981 with the U.S. Food and Drag Administration (" FDA" ) for approval to market saxaglitptin hydrochloride tablets--generic versions of AstraZeneca's ONGLYZA® drag product--and saxaglitptin hydrochloride and metformin hydrochloride extended-release tablets--generic versions of AstraZeneca's KOMBIGLYZE[TM] XR drag product--prior to expiration of the '400 Patent, the '186 Patent, and the '799 Patent. ( Id. ¶ ¶ 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.

Page 552


AstraZeneca is a company operating and existing under the laws of Sweden, with its principal place of business in Sö dertä lje, Sweden. (D.I. 1, ¶ 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, Delaware. ( Id. ¶ 5.) Mylan is incorporated in West Virginia and has its principal place of business in Morgantown, West Virginia. ( Id. ¶ 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.

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, ¶ 10.) Mylan has no property or employees in Delaware, and Mylan conducts essentially no direct sales in Delaware. ( Id. ¶ ¶ 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.)


The 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 establishing that the defendants are properly subject to the court's jurisdiction. See ICT Pharms., Inc. v. Boehringer Ingelheim Pharms., 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. Inamed 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; see Merck & Co., Inc. v. Barr Labs., Inc., 179 ...

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