Searching over 5,500,000 cases.

Buy This Entire Record For $7.95

Download the entire decision to receive the complete text, official citation,
docket number, dissents and concurrences, and footnotes for this case.

Learn more about what you receive with purchase of this case.

Acorda therapeutics, Inc. v. Mylan Pharms. Inc.

United States District Court, D. Delaware

January 14, 2015


Page 573

[Copyrighted Material Omitted]

Page 574

[Copyrighted Material Omitted]

Page 575

For Plaintiffs: 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.

For Defendants: 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.


Page 576

Leonard P. Stark, United States 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, 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-ffivolous claim that Mylan Inc. used Mylan Pharma as its agent in connection with the ANDA filing giving rise to this litigation. Therefore,

Page 577

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.


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

Page 578

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 ΒΆ 5) These figures do not include any revenue the Mylan Defendants derive ...

Buy This Entire Record For $7.95

Download the entire decision to receive the complete text, official citation,
docket number, dissents and concurrences, and footnotes for this case.

Learn more about what you receive with purchase of this case.