ROBINSON, District Judge
On October 22, 2015, Pfizer Inc., Wyeth LLC, Pfizer Pharmaceuticals LLC, PF PRISM C.V., and Pfizer Manufacturing Holdings LLC, (collectively "plaintiffs") filed a complaint alleging infringement of three patents related to its injectable antibiotic product TYGACIL® ("Tygacil") against defendants Mylan Inc., Mylan N.V., Mylan Laboratories Ltd. ("MLL"), and Mylan Pharmaceuticals ("MPI") (collectively "defendants"). (D.I. 1) Presently before the court is defendants' motion to dismiss for lack of personal jurisdiction and improper venue. (D.I. 6) Defendants Mylan Inc., Mylan N.V., and MPI have also filed a motion dismiss for failure to state a claim. (Id.) The court has jurisdiction over this matter pursuant to 28 U.S.C. §§ 1331 and 1338(a).
Plaintiff Pfizer Inc. is a corporation organized and existing under the laws of the State of Delaware with a principal place of business in New York, New York. (D.I. 1 at ¶ 2) Plaintiff Wyeth LLC is a Delaware limited liability company with a principal place of business in New York, New York. (Id. at ¶ 3) Wyeth LLC's sole member is Pfizer Inc. (Id.) Plaintiff Pfizer Pharmaceuticals LLC is a Delaware limited liability company with a principal place of business in Vega Baja, Puerto Rico. (Id. at ¶ 4) Pfizer Pharmaceuticals LLC is a wholly-owned subsidiary of PF PRISM C.V. (Id.) Plaintiff PF PRISM C.V. is a Dutch limited partnership with a principal place of business in Rotterdam, Holland. (Id. at ¶ 5) Plaintiff Pfizer Manufacturing Holdings LLC is a Delaware limited liability company with a principal place of business in New York, New York. (Id. at ¶ 6) Pfizer Manufacturing Holdings LLC is a general partner of PF PRISM C.V. (Id.)
MPI is a corporation organized and existing under the laws of the State of West Virginia with a principal place of business in Morgantown, West Virginia, and is a wholly-owned subsidiary of Mylan Inc. (D.I. 9 at ¶¶ 3, 4) MPI is registered to do business in Delaware. (D.I. 21 at 6) Mylan N.V. is a Dutch corporation, with a principal place of business in Hatfield, England. (D.I. 8 at ¶ 11) Mylan Inc. is a corporation organized and existing under the laws of the State of Pennsylvania with a principal place of business in Canonsburg, Pennsylvania. (Id. at ¶ 4) MLL is an Indian corporation with a principal place of business in Hyderabad, India and is a subsidiary of
On September 11, 2015, MLL sent a notice letter pursuant to 21 U.S.C. § 355(b)(3) to plaintiffs in New York and Puerto Rico, notifying plaintiffs that MLL had submitted NDA No. 208461 to the Food and Drug Administration ("FDA"). (D.I. 1 at ¶¶ 1, 28) The notice letter advised plaintiffs that MLL sought to market a generic injectable tigecycline product in the United States and that one or more of plaintiffs' patents were invalid, unenforceable, and/or would not be infringed. Tigecycline products are used in the treatment of various bacterial infections such as staph and E. coli. (D.I. 7 at 3-4)
On October 22, 2015, plaintiffs filed the instant action for patent infringement arising out of defendants' submission of NDA No. 208461, seeking approval to manufacture and sell a generic version of Pfizer's Tygacil, a tigecycline injectable IV infusion prior to the expiration of U.S. Patent Nos. 7,879,828; 8,372,995; and 8,975,242. On October 23, 2015, plaintiffs filed a protective suit in the Northern District of West Virginia (the "West Virginia Action"). (D.I. 21 at 3) Plaintiffs characterize the West Virginia Action as a "purely protective suit" filed "in order to protect the statutory right to a 30-month stay on [d]efendants' generic product." (Id.) Defendants describe the West Virginia Action as a "nearly identical suit" to the instant case. (D.I. 7 at 4) While plaintiffs did not serve the complaint in the West Virginia Action, defendants have answered the complaint and submitted counterclaims. (D.I. 21 at 3)
Rule 12(b)(2) of the Federal Rules of Civil Procedure directs the court to dismiss a case when the court lacks personal jurisdiction over a defendant. Fed. R. Civ. P. 12(b)(2). When reviewing a motion to dismiss pursuant to Rule 12(b)(2), a court must accept as true all allegations of jurisdictional fact made by plaintiff and resolve all factual disputes in plaintiff's favor. Traynor v. Liu, 495 F.Supp.2d 444, 448 (D.Del.2007).
Once a jurisdictional defense has been raised, plaintiff bears the burden of establishing, with reasonable particularity, that sufficient minimum contacts have occurred between defendant and the forum to support jurisdiction. See Provident Nat'l Bank v. Cal. Fed. Sav. & Loan Ass'n, 819 F.2d 434, 437 (3d Cir.1987). To meet this burden, plaintiff must produce "sworn affidavits or other competent evidence," since a Rule 12(b)(2) motion "requires resolution of factual issues outside the pleadings." Time Share Vacation Club v. Atlantic Resorts, Ltd., 735 F.2d 61, 67 n. 9 (3d Cir. 1984). Pursuant to the relevant portions of Delaware's long-arm statute, 10 Del. C. § 3104(c), a court may exercise personal jurisdiction over a defendant when a defendant or its agent:
As noted, the Supreme Court held in Daimler that "[w]ith respect to a corporation, the place of incorporation and principal place of business are "paradig[m] ... bases for general jurisdiction." Daimler AG, 134 S.Ct. at 760. While the Court did reject the idea that these "exemplar bases" are the only places where general jurisdiction could be found, it held that using a "substantial, continuous, and systematic course of business" to confer general jurisdiction is "unacceptably grasping." Id. at 761. While defendants may have "regularly and routinely litigated NDA and abbreviated new drug application ("ANDA") cases without contesting jurisdiction in this judicial district" and "engaged in a persistent course of conduct within Delaware by continuously and systematically placing goods into the stream of commerce for distribution throughout the United States, including Delaware," defendants are not Delaware corporations and do not have a principal places of business in Delaware. (D.I. 1 at ¶¶ 15-16; D.I. 7 at 6) Accordingly, the court finds that it does not have general jurisdiction over defendants.
Plaintiffs allege that this court has specific jurisdiction over MLL. In order to determine if the court has specific personal jurisdiction over a defendant, courts use a two-step inquiry. Elecs. For Imaging, Inc. v. Coyle, 340 F.3d 1344, 1349 (Fed.Cir.2003). First, the court considers "whether a forum state's long-arm statute permits service of process." Id. Second, the court considers "whether the assertion of jurisdiction would be inconsistent with due process." Id. In Acorda Therapeutics Inc. v. Mylan Pharm. Inc., 817 F.3d 755 (Fed.Cir.2016), plaintiffs sued defendants (MPI and Mylan, Inc.) for patent infringement. MPI prepared and filed an ANDA outside of Delaware and "intend[ed] to direct sales of its drugs into Delaware, among other places, once it ha[d] the requested FDA approval to market them." Id. at 758. The Federal Circuit stated that "there is no dispute that [MPI] would be subject to Delaware courts' jurisdiction under Delaware's long-arm statute, [10 Del. C. § 3104,] as long as Delaware's exercise of personal jurisdiction over [MPI] would be consistent with the Fourteenth Amendment's Due Process Clause." Id. at 759. "ANDA filings constitute formal acts that reliably indicate plans to engage in marketing of the proposed generic drugs" based on the plain text of the Hatch-Waxman Act which, "recognizes the close connection between an ANDA filing and the real-world acts that approval of the ANDA will allow and that will harm patent-owning brand-name manufacturers." Id. at 760. The "infringement inquiry called for by § 271(e)(2) is `whether, if a particular drug
In the case at bar, MLL sought "approval to market an injectable tigecycline product in the United States." As in Acorda, MLL's "ANDA filings constitute formal acts that reliably indicate plans to engage in marketing of the proposed generic drugs." Although MLL has not yet taken any activity in Delaware in this regard, it is undisputable that Delaware is a "State where [MLL and/or defendants] will engage in that marketing if the [NDA is] approved."
MLL may still "defeat specific personal jurisdiction by sufficiently demonstrating that other considerations render jurisdiction unreasonable." Id. at 763. To assist in determining when jurisdiction is unreasonable, the Supreme Court has set out a series of factors for consideration, which include "the burden on the defendant," "the forum State's interest in adjudicating the dispute," "the plaintiffs interest in obtaining convenient and effective relief," "the interstate judicial system's interest in
Defendants have litigated (and initiated) disputes in Delaware. Delaware has an interest in adjudicating this dispute, as plaintiffs are Delaware corporations. See McGee v. Int'l Life Ins. Co., 355 U.S. 220, 223, 78 S.Ct. 199, 2 L.Ed.2d 223 (1957) (noting that a forum state has a "manifest interest in providing effective means of redress for its residents."). Plaintiffs' "interest in obtaining convenient and effective relief' is met here. Plaintiffs may obtain relief either in Delaware or in West Virginia. This factor is neutral. World-Wide Volkswagen Corp., 444 U.S. at 292, 100 S.Ct. 559. Litigating this case in Delaware would, as plaintiffs note, "advance judicial efficiency," as other cases regarding tigecycline products are currently before this court. (D.I. 21 at 16); AstraZeneca AB v. Mylan Pharm., Inc., 72 F.Supp.3d 549, 560 (D.Del.2014).
Plaintiffs request that the court impute MLL's jurisdictional contacts to Mylan Inc., Mylan N.V., and MPI under an agency theory, as MLL acted under the control of Mylan Inc., Mylan N.V., and MPI in preparing and filing the NDA, as well as in sending the notice letter to Pfizer. (D.I. 21 at 12) To "establish jurisdiction under an agency theory," plaintiffs must "show that the defendant exercises control over the activities of the third-party." Celgard, LLC v. SK Innovation Co., 792 F.3d 1373, 1379 (Fed.Cir.2015); see Daimler AG, 134 S.Ct. at 759 n. 13 ("[A] corporation can purposefully avail itself of a forum by directing its agents or distributors to take action there."); Cephalon, Inc. v. Watson Pharm., Inc., 629 F.Supp.2d 338, 348 (D.Del.2009) ("Under the agency theory, the court may attribute the actions of a subsidiary company to its parent where the subsidiary acts on the parent's behalf or at the parent's direction."). If the court finds that an agency relationship exists, the court "will not ignore the separate corporate identities of parent and subsidiary, but will consider the parent corporation responsible for specific jurisdictional acts of the subsidiary." Applied Biosystems, Inc. v. Cruachem, Ltd., 772 F.Supp. 1458, 1463 (D.Del.1991). This theory applies "not only to parents and subsidiaries, but also to companies that are `two arms of the same business group,' operate in concert with each other, and enter into agreements with each other that are nearer than arm's length." Cephalon, Inc., 629 F.Supp.2d at 348. To decide if an agency relationship exists, "a court should focus its inquiry on the arrangement between the parent and the subsidiary, the authority given in that arrangement, and the relevance of that arrangement to the plaintiff's claim." C.R. Bard, Inc. v. Guidant Corp., 997 F.Supp. 556, 560 (D.Del.1998); see Wesley-Jessen Corp. v. Pilkington Visioncare, Inc., 863 F.Supp. 186, 188 (D.Del.1993) (finding an agency relationship when "the business strategies and financial statements of the defendant companies are analyzed as a unit, and these companies present themselves as a unified entity to their employees and to the marketplace"). Other factors have been described as "the extent of overlap of officers and directors, methods of financing, the division of responsibility for day-to-day management, and the process by which each corporation obtains its business." Applied Biosystems, Inc., 772 F.Supp. at 1463. No specific factor is "either necessary or determinative," and instead "it is the specific combination of elements which is significant." Id. However, "only acts by the agent which were
At bar, plaintiffs allege many of the factors from Applied Biosystems in the complaint.
Rule 12(b)(3) of the Federal Rules of Civil Procedure provides that a motion to dismiss may be made on the basis of improper venue. Fed. R. Civ. P. 12(b)(3). The purpose of venue, in most instances, "is to protect the defendant against the risk that a plaintiff will select an unfair or inconvenient place of trial." Cottman Transmission Sys., Inc. v. Martino, 36 F.3d 291, 294 (3d Cir.1994). Title 28 of U.S.C. § 1400(b) provides that a "civil action for patent infringement may be brought in the judicial district where the defendant resides, or where the defendant has committed acts of infringement and has a regular and established place of business." 28 U.S.C. § 1400(b) (2006). For the purposes of venue, a defendant "that is a corporation ... reside[s] in any judicial district in which it is subject to personal jurisdiction at the time the action is commenced." Id. § 1391(c). Additionally, § 1391(d) states that an alien may be sued in any district.
The parties do not dispute that venue for a patent suit is proper wherever the court has personal jurisdiction. (D.I. 21 at 17, D.I. 23 at 7) Furthermore, the Federal Circuit has held that "venue in a patent
For the foregoing reasons, the court denies defendants' motion to dismiss for lack of personal jurisdiction as to MPI and MLL. The court grants plaintiffs' request for jurisdictional discovery and denies without prejudice to renew defendants' motion to dismiss for lack of personal jurisdiction as to Mylan Inc. and Mylan N.V.; for improper venue; and for failure to state a claim. (D.I. 6) An appropriate order shall issue.
At Wilmington this 12th day of August, 2016, consistent with the memorandum opinion issued this same date;
IT IS ORDERED that defendants' motion to dismiss (D.I. 6) is denied in part and stayed in part.