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United States Court of Appeals for the Federal Circuit
March 18, 2016, Decided
[*757] [***1304] Taranto, Circuit Judge.
These appeals involve two actions brought in the District of Delaware against generic [***1305] drug manufacturer Mylan Pharmaceuticals Inc. One, assigned to Chief Judge Stark, was brought by brand-name drug manufacturers Acorda Therapeutics Inc. and Alkermes Pharma Ireland Ltd.; the other, assigned to Judge Sleet, was brought by brand-name drug manufacturer AstraZeneca AB. The plaintiffs brought the actions under 35 U.S.C. § 271(e)(2), alleging that their patents cover drugs that Mylan has sought permission from the Food and Drug Administration to manufacture and market. Mylan moved to dismiss on the ground that Delaware could not (and so the federal court may not) exercise personal jurisdiction—either general or specific personal jurisdiction—over Mylan in these cases. Chief Judge Stark and Judge Sleet denied the motions. Although they reached different conclusions about whether Delaware could exercise general personal jurisdiction over Mylan based on consent given in registering to do [**4] business in the State, they both concluded that Delaware could exercise specific personal jurisdiction, based on Mylan's suit-related contacts with Delaware. On interlocutory appeal, we affirm, holding that Mylan is subject to specific personal jurisdiction in these cases. We do not address the issue of general personal jurisdiction.
Under the authority of the FDA's approval of its New Drug Application (NDA), 21 U.S.C. § 355(a), (c), Acorda markets Ampyra® to help individuals with multiple sclerosis walk. In seeking approval for Ampyra®, Acorda identified five patents for listing in the FDA's Approved Drug Products with Therapeutic Equivalence Evaluations publication—the "Orange Book." See 21 U.S.C. § 355(b)(1); 21 C.F.R. §§ 314.3, 314.53. Acorda owns four of the patents and is the exclusive licensee of the fifth, owned by Alkermes. In January 2014, Mylan filed an Abbreviated New Drug Application (ANDA) with the FDA under 21 U.S.C. § 355(j), seeking approval to market generic versions of Ampyra®. Under paragraph IV of § 355(j)(2)(A)(vii), Mylan certified that Acorda's Orange Book patents for Ampyra® are invalid or would not be infringed by Mylan's marketing of its proposed drug. Acorda and Alkermes then sued Mylan in the District of Delaware for patent infringement, invoking [**5] the declaration of 35 U.S.C. § 271(e)(2)(A) that the submission of a paragraph IV certification constitutes an act of infringement.1
AstraZeneca markets FDA-approved Onglyza® and KombiglyzeTM to help individuals with type II diabetes. AstraZeneca [*758] owns three patents listed in the Orange Book for those drugs. Mylan filed two ANDAs seeking approval to market generic versions of the two drugs and certified that AstraZeneca's three patents are invalid or would not be infringed by Mylan's marketing of its proposed drugs. AstraZeneca sued Mylan for infringement under 35 U.S.C. § 271(e)(2)(A) in the District of Delaware.
Full case includes Shepard's, Headnotes, Legal Analytics from Lex Machina, and more.
817 F.3d 755 *; 2016 U.S. App. LEXIS 4942 **; 118 U.S.P.Q.2D (BNA) 1304 ***; 2016 WL 1077048
ACORDA THERAPEUTICS INC., ALKERMES PHARMA IRELAND LIMITED, Plaintiffs-Appellees v. MYLAN PHARMACEUTICALS INC., MYLAN INC., Defendants-Appellants; ASTRAZENECA AB, Plaintiff-Appellee v. MYLAN PHARMACEUTICALS INC., Defendant-Appellant
Subsequent History: US Supreme Court certiorari denied by Mylan Pharm. v. Acorda Therapeutics, 137 S. Ct. 625, 196 L. Ed. 2d 580, 2017 U.S. LEXIS 603 (U.S., Jan. 9, 2017)
Prior History: [**1] Appeal from the United States District Court for the District of Delaware in No. 1:14-cv-00935-LPS, Chief Judge Leonard P. Stark.
Appeal from the United States District Court for the District of Delaware in Nos. 1:14-cv-00664-GMS, 1:14-cv-00696-GMS, Judge Gregory M. Sleet.
Acorda Therapeutics, Inc. v. Mylan Pharms. Inc., 78 F. Supp. 3d 572, 2015 U.S. Dist. LEXIS 4056 (D. Del., Jan. 14, 2015)AstraZeneca AB v. Mylan Pharms., Inc., 72 F. Supp. 3d 549, 2014 U.S. Dist. LEXIS 156660 (D. Del., Nov. 5, 2014)
personal jurisdiction, patent, do business, infringement, manufacturer, marketing, cases, generic, drugs, registered, foreign corporation, service of process, general jurisdiction, planned, appointed, filings, filer, certification, district court, courts, sales, registration statute, suit-related, connected, parties, minimum-contacts, brand-name, compliance, consented, decisions
Civil Procedure, Jurisdiction, In Rem & Personal Jurisdiction, In Personam Actions, Pleadings, Service of Process, Service of Summons, Patent Law, Jurisdiction & Review, Standards of Review, De Novo Review, In Personam Actions, Due Process, Minimum Contacts, Business & Corporate Compliance, Infringement Actions, Patent Law, Infringement Actions, Remedies, Damages, Equitable Relief, Injunctions, Constitutional Law, The Judiciary, Case or Controversy