Bristol-Myers Squibb Co. v. Mylan Pharms. Inc.
| Decision Date | 11 September 2017 |
| Docket Number | C.A. No. 17-379-LPS |
| Parties | BRISTOL-MYERS SQUIBB COMPANY and PFIZER INC., Plaintiffs, v. MYLAN PHARMACEUTICALS INC., Defendant. |
| Court | U.S. District Court — District of Delaware |
Joseph J. Farnan, Jr., Brian E. Farnan, and Michael J. Farnan, FARNAN LLP, Wilmington, DE
Amy K. Wigmore, Gregory H. Lantier, Tracey C. Allen, Heather M. Petruzzi, and Jeffrey T. Hanston, WILMER CUTLER PICKERING HALE AND DORR LLP, Washington, DC
Andrew J. Danford, Timothy A. Cook, and Kevin M. Yurkerwich, WILMER CUTLER PICKERING HALE AND DORR LLP, Boston, MA
Attorneys for Plaintiffs.
Stamatios Stamoulis and Richard C. Weinblatt, STAMOULIS & WEINBLATT LLC, Wilmington, DE
Robert L. Florence, Micheal L. Binns, Karen L. Carroll, and Sharad K. Bijanki, PARKER POE ADAMS & BERNSTEIN LLP, Atlanta, GA
Melanie Black Dubis, Christopher M. Thomas, and Catherine R. L. Lawson, PARKER POE ADAMS & BERNSTEIN LLP, Raleigh, NC
Katherine H. Graham, PARKER POE ADAMS & BERNSTEIN LLP, Charlotte, NC
Brandon M. White, PERKINS COIE LLP, Washington DC
Attorneys for Defendant.
September 11, 2017
Wilmington, Delaware
Presently before the Court is Mylan Pharmaceuticals Inc.'s ("MPI" or "Defendant") motion to dismiss for improper venue in light of the Supreme Court's recent decision in TC Heartland LLC v. Kraft Food Group Brands LLC, 137 S. Ct. 1514 (2017). (D.I. 14)
It is undisputed that after TC Heartland, which held that a corporate defendant "resides" only in its state of incorporation for purposes of determining where venue is proper in a patent case, see 28 U.S.C. § 1400(b), MPI, a West Virginia corporation, can no longer be said to "reside" in Delaware. TC Heartland did not, however, address the second prong of § 1400(b), which makes venue proper in a district "where the defendant has committed acts of infringement and has a regular and established place of business."
MPI, which has submitted an Abbreviated New Drug Application ("ANDA") to the United States Food and Drug Administration ("FDA") for permission to market and sell a generic version of one of Plaintiffs' patent-protected drug products, bears the burden to show that it does not satisfy the requirements of the second prong of § 1400(b). Given the language of the statute giving rise to Plaintiffs' cause of action, 35 U.S.C. § 271(e)(2), as well as the unique realties of ANDA-related patent litigation, MPI has failed to meet its burden to show that it has not committed acts of infringement in Delaware. However, the record is less clear with respect to whether MPI has a "regular and established place of business" here. Accordingly, the Court will permit expedited venue-related discovery so that it may thereafter determine if venue is proper here. In the meantime, this case - which is related to two dozen other cases relating to the same branded pharmaceutical, Eliquis® - will proceed on the merits.
Therefore, for the reasons set forth below, the Court will deny MPI's motion to dismissfor improper venue, without prejudice to MPI having an opportunity to renew its motion should it believe, after expedited venue-related discovery is complete, it can meet its burden to show that it does not have a "regular and established place of business" in Delaware.
This is a patent infringement action brought by Bristol-Myers Squibb Co. and Pfizer Co. (collectively, "BMS" or "Plaintiffs") under the Drug Price Competition and Patent Term Restoration Act of 1984, commonly referred to as the "Hatch-Waxman Act." 21 U.S.C. § 355(j). Defendant MPI submitted an ANDA to market a generic version of BMS' Eliquis®, 2.5 mg and 5 mg strength apixaban tablets ("ANDA product"). (D.I. 1 at ¶ 2) BMS asserts Orange Book-listed1 U.S. Patent Nos. 6,967,208 and 9,326,945, which generally describe and claim chemical compounds, including apixaban, and apixaban formulations.
MPI is a corporation organized under the laws of West Virginia, having its principal place of business in Morgantown, West Virginia. (D.I. 16 at ¶ 3) MPI "is in the business of making and selling generic pharmaceutical products, which it distributes in the State of Delaware and throughout the United States." (D.I. 1 at ¶ 10) MPI is registered with the Delaware Board of Pharmacy as a licensed "Pharmacy - Wholesale" and "Distributor/Manufacturer CSR." (Id. at ¶ 9) However, MPI does not have any manufacturing plants, corporate offices, facilities, other real property, telephone listings, mailing addresses, or employees in Delaware. (See D.I. 16 at¶ 2)2
On March 2, 2017, MPI notified BMS that it had submitted its ANDA to the FDA pursuant to § 505(j) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 355(j), (D.I. 1 at ¶ 20) The notice letter stated that MPI seeks approval from the FDA to engage in the commercial manufacture, use, and sale of the MPI ANDA product before the expiration of the patents-in-suit. (Id. at ¶ 21)
On April 5, 2017, BMS initiated the present action by filing the complaint here in the District of Delaware. BMS' complaint alleges that MPI's submission of the ANDA "to obtain approval to engage in the commercial manufacture, use, offer to sell, or sale of the [MPI] ANDA product prior to the expiration" of BMS' patents constituted a technical act of infringement under 35 U.S.C. § 271(e)(2)(A). (Id. at ¶¶ 28, 34) The complaint further alleges that, upon FDA approval of MPI's ANDA, MPI will infringe, either literally or under the doctrine of equivalents, BMS' patents "by making, using, offering to sell, and selling the [MPI] ANDA product in the United States and/or importing said product into the United States, or by actively inducing and contributing to infringement . . . by others, under 35 U.S.C. § 271(a)-(c), unless enjoined by the Court." (Id. at ¶¶ 31, 36)
Also in the complaint, BMS alleges that "[v]enue is proper in this Court under 28 U.S.C. §§ 1391 and/or 1400(b), including because, inter alia, [MPI] is subject to personal jurisdiction in this district, as set forth above, has committed an act of infringement and will commit further actsof infringement in this judicial district . . . [and] has a regular and established place of business in this judicial district." (Id. at ¶ 15) BMS further alleges that MPI "has committed an act of patent infringement under 35 U.S.C. § 271(e)(2) and intends a future course of conduct that includes acts of patent infringement in Delaware," elaborating that MPI "will make, use, import, sell, and/or offer for sale the [MPI] ANDA product in the United States, including in Delaware, prior to the expiration of the patents-in-suit." (Id. at ¶ 12)
On May 10, 2017, MPI answered the complaint and, among other things, asserted improper venue as an affirmative defense. (See D.I. 10 at 12)
On May 22, 2017, the Supreme Court issued its decision in TC Heartland, "hold[ing] that a domestic corporation 'resides' only in its State of incorporation for purposes of the patent venue statute," adding that "amendments to § 1391 did not modify the meaning of § 1400(b)." 137 S. Ct. at 1517. The Supreme Court did not construe the second prong of § 1400(b), which makes venue in a patent case proper where a defendant "has committed acts of infringement and has a regular and established place of business."
On July 25, 2017, MPI moved to dismiss for improper venue under Federal Rule of Civil Procedure 12(b)(3), contending that venue is not proper under either the residency or place of business prongs of § 1400(b). (D.I. 14) Plaintiffs do not contend that MPI's motion is untimely.
Briefing on the motion was completed on August 18, 2017. (See D.I. 15, 21, 25) The Court heard oral argument on August 24, 2017. (See D.I. 35 ("Tr."))3
Generally, "venue provisions are designed, not to keep suits out of the federal courts, but merely to allocate suits to the most appropriate or convenient federal forum." Brunette Mach. Works, Ltd. v. Kockum Indus., Inc., 406 U.S. 706, 710 (1972). Rule 12(b)(3) authorizes a party to move to dismiss a lawsuit for improper venue. When such a motion is filed, the Court must determine whether venue is proper in accordance with the applicable statutes. See Albright v. W.L. Gore & Assocs., Inc., 2002 WL 1765340, at *3 (D. Del. July 31, 2002). Venue in a patent infringement action is governed solely and exclusively by the patent venue statute, 28 U.S.C. § 1400(b). See TC Heartland, 137 S. Ct. at 1516. The general venue statute, 28 U.S.C. § 1391(c), does not have any application in a patent case. See id. at 1521.
If the Court grants a Rule 12(b)(3) motion based on improper venue, the Court "shall dismiss, or if it be in the interest of justice, transfer such case to any district or division in which it could have been brought." 28 U.S.C. § 1406(a).4
Generally, "it is not necessary for the plaintiff to include allegations in his complaint showing that venue is proper." Great W. Mining & Mineral Co. v. ADR Options, Inc., 434 F. App'x 83, 86-87 (3d Cir. 2011). Hence, when confronted with a motion to dismiss for improper venue, the Court may consider both the complaint and evidence outside the complaint. See 14D Wright & Miller, Federal Practice & Procedure § 3826 (4th ed. 2017). The Court will accept any venue-related allegations in the complaint as true, unless those allegations are contradicted by the defendant's affidavits. See Bockman v. First Am. Mktg. Corp., 459 F. App'x 157, 158 n.1 (3dCir. 2012); In re First Solar, Inc. Derivative Litig., 2013 WL 817132, at *2 (D. Del. Mar. 4, 2013). In addition, the Court may consider affidavits submitted by the plaintiff. See Bockman, 459 F. App'x at 161 ().
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