Acorda Therapeutics, Inc. v. Mylan Pharm. Inc.

• Decision Date: 14 January 2015
• Docket Number: Civil Action No. 14–935–LPS
• Citation: 78 F.Supp.3d 572
• Parties: Acorda Therapeutics, Inc. and Alkermes Pharma Ireland Limited, Plaintiffs, v. Mylan Pharmaceuticals Inc. and Mylan Inc., Defendants.
• Court: U.S. District Court — District of Delaware

78 F.Supp.3d 572

Acorda Therapeutics, Inc. and Alkermes Pharma Ireland Limited, Plaintiffs

v.Mylan Pharmaceuticals Inc. and Mylan Inc., Defendants.

Civil Action No. 14–935–LPS

United States District Court, D. Delaware.

Signed January 14, 2015

Jack B. Blumenfeld and Maryellen Noreika, MORRIS, NICHOLS, ARSHT & TUNNELL, LLP, Wilmington, DE, Aaron Stiefel, Daniel P. DiNapoli, Benjamin C. Hsing, and Soumitra Deka, KAYE SCHOLER, LLP, New York, NY, Sylvia M. Becker, KAYE SCHOLER, LLP, Washington, DC, Anthony Michael, ACORDA THERAPEUTICS, INC., Ardsley, NY, Attorneys for Plaintiffs

Mary B. Matterer and Richard K. Herrmann, MORRIS JAMES, LLP, Wilmington, DE, Timothy H. Kratz, George J. Barry III, Karen L. Carroll, and Brie L.B. Buchanan, MCGUIREWOODS, LLP, Atlanta, GA, Cedric C.Y. Tan, MCGUIREWOODS, LLP, Washington, DC, Attorneys for Defendants

OPINION

STARK, U.S. District Judge:

Defendants Mylan Pharmaceuticals Inc. (“Mylan Pharma”) and Mylan Inc. (“Mylan Inc.” and, together with Mylan Pharmaceuticals, “Mylan” or “Defendants”) have moved to dismiss the complaint filed against them by Plaintiffs Acorda Therapeutics, Inc. (“Acorda”) and Alkermes Pharma Ireland Limited (“Alkermes” and, together with Acorda, “Plaintiffs”). (D.I.10) Defendants bring their motion pursuant to Federal Rule of Civil Procedure 12(b)(2), asserting a lack of personal jurisdiction. Specifically, Mylan contends that the Supreme Court's recent decision in Daimler AG v. Bauman, ––– U.S. ––––, 134 S.Ct. 746, 187 L.Ed.2d 624 (2014), has resulted in the District of Delaware lacking general jurisdiction over Mylan in this (and likely all)¹ Abbreviated New Drug Application (“ANDA”) lawsuits. Mylan further contends that its relationship with Delaware and with this litigation does not support the exercise of specific jurisdiction.

After reviewing thorough briefing and hearing oral argument, the Court has concluded that it does have personal jurisdiction over Mylan Pharma in this action. While Daimler altered the analysis with respect to general jurisdiction—and the Court agrees with Mylan that this Court cannot exercise general personal jurisdiction over either of the Mylan Defendants on the basis that they are “at home” in Delaware—Daimler does not change the fact that Mylan Pharma consented to this Court's exercise of personal jurisdiction when it registered to do business and appointed an agent for service of process in the State of Delaware. In addition, Plaintiffs have met their burden to establish that this Court has personal jurisdiction over Mylan Pharma based on specific jurisdiction, which provides an independent reason for denying the motion as it relates to Mylan Pharma.

With respect to Mylan Inc., which is the parent of Mylan Pharma, the Court lacks general jurisdiction, as Mylan Inc. is neither “at home” nor registered to do business in Delaware. However, Plaintiffs allege but have not proven a non-frivolous claim that Mylan Inc. used Mylan Pharma as its agent in connection with the ANDA filing giving rise to this litigation. Therefore, the Court will permit Plaintiffs to take jurisdictional discovery of Mylan Inc.'s relationship with Mylan Pharma and with the ANDA filing at issue in this case.

BACKGROUND

I. Plaintiffs: Acorda and Alkermes

Plaintiff Acorda is a corporation organized under the laws of the State of Delaware, having a principal place of business in Ardsley, New York. (D.I. 1 at ¶ 3) Acorda researches, develops, and sells biotech and pharmaceutical products, including therapies to restore neurological functioning in people with multiple sclerosis (“MS”). (Id. ) Plaintiff Alkermes is a corporation organized under the laws of Ireland, having a principal place of business in Dublin, Ireland. (Id. at ¶ 4)

Acorda's “flagship drug product” is Ampyra ®, which has been shown to improve walking in people with MS. (Id. at ¶¶ 2, 30) Acorda holds New Drug Application (“NDA”) No. 022250, approved by the U.S. Food and Drug Administration (“FDA”), for the use of 10 mg dalfampridine extended release tablets. (Id. at ¶ 30) It is this product which Acorda sells under the registered name Ampyra ®. (Id. )

There are five patents-in-suit: U.S. Patent Nos. 5,540,938 (the “ '938 patent”), 8,007,826 (the “ '826 patent”), 8,354,437 (the “ '437 patent”), 8,440,703 (the “ '703 patent”), and 8,663,685 (the “ '685 patent”) (collectively, “the Ampyra ® patents”). All of the Ampyra ® patents are listed in the FDA's “Orange Book”² and have expiration dates of between 2018 and 2027. (Id. at ¶¶ 32–33) Acorda is the exclusive U.S. licensee of the '938 patent —which is assigned to co-Plaintiff Alkermes—and has all right, title, and interest in the other four Ampyra ® patents. (Id. at ¶¶ 5–6, 25)

II. Defendants: Mylan Pharma and Mylan Inc.

Mylan Pharma is a corporation organized under the laws of the State of West Virginia, having a principal place of business in Morgantown, West Virginia. (Id. at ¶ 7; D.I. 12 at 2) It “formulat[es], develop[s], manufactur[es], packag[es], market[s], and sell[s] generic copies of branded pharmaceutical products for the United States market, including in Delaware.” (D.I. 1 at ¶ 8)

On April 7, 2010, pursuant to sections 371 and 376 of title 8 of the Delaware Code, Mylan Pharma qualified to do business in Delaware, by filing with the Secretary of State (1) a certificate of incorporation, representing its business as “[p]harmaceutical manufacturing, distribution and sales,” and (2) and a statement naming Corporation Services Company, in Wilmington, Delaware, as its registered agent to accept service of process in the State of Delaware. (D.I. 1 at ¶ 7; D.I. 15 at 5; D.I. 16, Exs. A & B) Mylan Pharma is also registered with the Delaware Board of Pharmacy as a licensed “Pharmacy–Wholesale” and a “Distributor/Manufacturer CSR.” (D.I. 1 at ¶ 9; D.I. 16, Exs. C & D) Additionally, Mylan Pharma has “litigat[ed], as a defendant, over 50 other civil actions initiated in this jurisdiction in the last 19 years and affirmatively invoked this Court's jurisdiction by asserting counterclaims in at least 46 of those cases.” (D.I. 1 at ¶ 17)

Mylan Inc. is a corporation organized under the laws of the Commonwealth of Pennsylvania, having a principal place of business in Canonsburg, Pennsylvania. (Id. at ¶ 10) Mylan Inc. is “a pharmaceutical company which develops, licenses, manufacturers, markets and distributes generic pharmaceuticals in the U.S.” (Id. at ¶ 11) In fact, Mylan Inc. reports that “it is one of the largest generic pharmaceutical companies in the world today in terms of revenue as a result of, inter alia, its ‘ability to efficiently obtain [ANDA] approvals.” (Id. at ¶ 19; D.I. 16, Ex. E at 5) More particularly, Mylan Inc. “holds the number one ranking in the U.S. generics prescription market in terms of sales and the number two ranking in terms of prescriptions dispensed.” (D.I. 1 at ¶ 19)

Although 20 Mylan Inc. subsidiaries have incorporated in Delaware (see D.I. 16, Ex. E at 37–40), Mylan Inc. is not registered to do business in Delaware (see Tr. at 43). Mylan Inc. has “litigat[ed] as a defendant and assert[ed] counterclaims in at least 15 cases initiated in this jurisdiction over the past ten years.” (D.I. 1 at ¶ 20)

Neither of the Defendants has any manufacturing plants, offices, facilities, other real property, a telephone listing, or a mailing address in the State of Delaware. (D.I. 12 at ¶ 5) In 2013, Mylan Pharma had no sales in Delaware, and that same year Mylan Inc.'s sales in Delaware produced just $429 in revenue. (Id. at ¶ 5) These figures do not include any revenue the Mylan Defendants derive from distribution of generic drug products in Delaware through out-of-state distributors. (See Tr. at 57)

Mylan Pharma is a wholly-owned subsidiary of Mylan Inc. (Id. at ¶ 7) Plaintiffs allege that Mylan Pharma and Mylan Inc. “are agents of each other and/or work in concert with each other with respect to the development, regulatory approval, marketing, sale, and distribution of pharmaceutical products throughout the United States, including into Delaware.” (Id. at ¶ 21) It is undisputed, however, that Defendants are separate corporate entities. (D.I. 17 at 8)

III. Mylan's ANDA Filing and ANDA Notice Letter

On January 22, 2014, Mylan Pharma filed ANDA No. 20–6858 (“Mylan's ANDA Filing”)³ seeking FDA approval to market generic 10 mg doses of dalfampridine extended release tablets (“Mylan's Generic Product”) in the United States before the expiration of the Ampyra ® patents. (D.I. 12 at ¶ 7; see also D.I. 1 at ¶ 36) Mylan's ANDA Filing included a “paragraph IV certification,” pursuant to 21 U.S.C. § 355(j)(2)(A)(vii)(IV), contending that the Ampyra ® patents are “invalid, unenforceable, and/or will not be infringed by the commercial manufacture, use or sale” of Mylan's Generic Product. (D.I. 1 at ¶ 35) Mylan Pharma prepared Mylan's ANDA Filing in West Virginia and filed it with the FDA in Maryland. (D.I. 12 at 2–3) Plaintiffs allege that “Defendants collaborated and acted in concert in the decision to file and the filing of ANDA No. 20–6858 identified in the Mylan Notice Letter.” (D.I. 1 at ¶ 37) If Mylan's Generic Product is approved by the FDA, it will be marketed and distributed, prescribed by physicians, and dispensed by pharmacies, throughout the United States, including in Delaware. (Id. at ¶¶ 22–23)

On July 9, 2014, Mylan Pharma gave Plaintiffs notice of Mylan's ANDA Filing (the “Mylan Notice Letter”). (Id. at ¶ 34) Specifically, Mylan Pharma mailed the Mylan Notice Letter to Acorda at its principal place of business in New York and also to Alkermes at its principal place of business in Ireland. (See Tr. at 24, 50)

IV. Plaintiffs' ANDA Suits

On July 16, 2014, Plaintiffs commenced this action, alleging that Defendants directly and indirectly infringed claims of all of the Ampyra ® patents by submitting or causing submission of the Mylan ANDA Filing. (D.I. 1 at 9–16) Because Plaintiffs filed suit within 45 days of receiving the Mylan Notice Letter, the FDA is...