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Acorda therapeutics Inc. v. Mylan Pharmaceuticals Inc.

United States Court of Appeals, Federal Circuit

March 18, 2016

MYLAN PHARMACEUTICALS INC., MYLAN INC., Defendants-Appellants; ASTRAZENECA AB, Plaintiff-Appellee

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          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.

         THEODORE B. OLSON, Gibson, Dunn & Crutcher LLP, Washington, DC, argued for all plaintiffs-appellees in 2015-1456. Plaintiff-appellee Acorda Therapeutics Inc. also represented by AMIR C. TAYRANI; SYLVIA BECKER, Kaye Scholer LLP, Washington, DC; SOUMITRA DEKA, DANIEL DINAPOLI, AARON STIEFEL, JEFFREY T. MARTIN, New York, NY; ANTHONY MICHAEL, JANE G. WASMAN, Acorda Therapeutics, Inc., Ardsley, NY.

         MARYELLEN NOREIKA, Morris, Nichols, Arsht & Tunnell LLP, Wilmington, DE, for plaintiff-appellee Alkermes Pharma Ireland Limited. Also represented by JACK B. BLUMENFELD, JEREMY A. TIGAN.

         KANNON K. SHANMUGAM, Williams & Connolly LLP, Washington, DC, argued for plaintiff-appellee in 2015-1460. Also represented by DAVID M. KRINSKY, KATHERINE MORAN MEEKS, AMY MASON SAHARIA.

         PAUL D. CLEMENT, Bancroft PLLC, Washington, DC, argued for defendants-appellants. Also represented by DAVID ZACHARY HUDSON, EDMUND GERARD LACOUR, JR.; DOUGLAS H. CARSTEN, Wilson, Sonsini, Goodrich & Rosati, PC, San Diego, CA.

         ANDREW JOHN PINCUS, Mayer Brown LLP, Washington, DC, for amicus curiae Chamber of Commerce of the United States of America. Also represented by PAUL WHITFIELD HUGHES; KATHRYN L. COMERFORD TODD, U.S. Chamber of Commerce, Washington, DC.

         JAMES HAROLD WALLACE, JR., Wiley Rein, LLP, Washington, DC, for amicus curiae Generic Pharmaceutical Association. Also represented by A. CLAIRE FREZZA, MARK PACELLA, ERIC HAROLD WEISBLATT.

         WILLIAM M. JAY, Goodwin Procter LLP, Washington, DC, for amicus curiae Teva Pharmaceuticals USA, Inc. Also represented by BRIAN TIMOTHY BURGESS.

         CHRISTOPHER J. GLANCY, White & Case LLP, New York, NY, for amicus curiae Biotechnology Industry Organization. Also represented by ADAM GAHTAN.

         DAVID W. OGDEN, Wilmer Cutler Pickering Hale and Dorr LLP, Washington, DC, for amicus curiae Pharmaceutical Research and Manufacturers of America. Also represented by THOMAS SAUNDERS, THOMAS GREGORY SPRANKLING; KEVIN SCOTT PRUSSIA, Boston, MA.

         CARTER GLASGOW PHILLIPS, Sidley Austin LLP, Washington, DC, for amici curiae Thomas C. Arthur, Richard D. Freer, Lisa A. Dolak, Megan M. LaBelle. Also represented by RYAN C. MORRIS, ANNA MAYERGOYZ WEINBERG.

         Before NEWMAN, O'MALLEY, and TARANTO, Circuit Judges. OPINION filed by Circuit Judge TARANTO. Opinion concurring in the judgment filed by Circuit Judge O'MALLEY.


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          Taranto, Circuit Judge.

         These appeals involve two actions brought in the District of Delaware against generic 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 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 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

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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.

         Mylan filed motions to dismiss under Federal Rule of Civil Procedure 12(b)(2) on the ground that the State of Delaware could not--and therefore, derivatively, the federal district court in Delaware may not--exercise personal jurisdiction over Mylan in these matters under the Due Process Clause of the Fourteenth Amendment. The parties do not dispute that the standards of the Due Process Clause control whether there is personal jurisdiction in these matters. Nor do they dispute that the Due Process Clause standards permit a State to exercise either specific personal jurisdiction over a defendant in a case (based on the connection of the State to the subject matter of the particular case) or general personal jurisdiction over the defendant (based on certain facts even where the case involves subject matter not itself sufficiently connected to the State). The parties have debated both specific and general personal jurisdiction in this case. The debate over the latter issue focuses on Mylan's registration to do business in Delaware as giving consent to the exercise of general personal jurisdiction.

         The motions were decided on facts that are not in material dispute. Mylan is incorporated in West Virginia and has its principal place of business there. Mylan submitted its ANDAs to the FDA in Maryland, and it did much if not all of its preparation of its ANDA filings in West Virginia. Regarding the notices of its ANDA filings required by 21 U.S.C. § 355(j)(2)(B)(iii), Mylan sent notices to Acorda in New York and Alkermes in Ireland (for the Acorda matter), and it sent notices to AstraZeneca's subsidiary in Delaware and AstraZeneca in Sweden (for the AstraZeneca matter). Mylan has registered to do business and appointed an agent to accept service in Delaware. And, of particular importance, Mylan intends to direct sales of its drugs into Delaware, among other places, once it has the requested FDA approval to market them. The plaintiffs, for their part, also have connections with Delaware: Acorda is incorporated in Delaware, AstraZeneca's U.S. subsidiary has its principal place of business in Delaware, and both Acorda and AstraZeneca have sued other generic manufacturers for infringement of the same patents in Delaware.

         Chief Judge Stark (in the Acorda case) and Judge Sleet (in the AstraZeneca case) denied the motions to dismiss. Both judges concluded that Delaware had sufficient contacts related to the subject of these cases that it could exercise specific personal jurisdiction over Mylan. See Acorda Therapeutics, Inc. v. Mylan Pharms. Inc., 78 F.Supp.3d 572, 593-95 (D. Del. 2015); Astrazeneca AB v. Mylan Pharms., Inc., 72 F.Supp.3d 549, 558-60 (D. Del. 2014). The two judges disagreed about whether Delaware could exercise general personal jurisdiction (independent of suit-related contacts) on the ground that Mylan consented to such jurisdiction in registering to do business: they took different views of the status of Supreme Court decisions supporting such jurisdiction, e.g., Pa. Fire Ins. Co. v. Gold Issue Mining & Milling Co., 243 U.S. 93, 37 S.Ct. 344, 61 L.Ed. 610 (1917), in light of later decisions such as Daimler AG v. Bauman, 134 S.Ct. 746, 187 L.Ed.2d 624 (2014). See Acorda, 78 F.Supp.3d at 587-90; AstraZeneca, 72 F.Supp.3d at 556-57. But the latter disagreement

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did not alter the finding of personal jurisdiction in these cases.

         In each case the district court certified its decision for interlocutory review, and we granted permission to appeal. We have jurisdiction under 28 U.S.C. § 1292(b) and (c)(1).


         Under Fed.R.Civ.P. 4(k)(1)(A), the district court has personal jurisdiction over Mylan in these cases if Mylan would be " subject to the jurisdiction of a court of general jurisdiction in the state where the district court is located," here Delaware. And there is no dispute that Mylan would be subject to Delaware courts' jurisdiction under Delaware's long-arm statute, Del. Code Ann. tit. 10, § 3104, as long as Delaware's exercise of personal jurisdiction over Mylan would be consistent with the Fourteenth Amendment's Due Process Clause. The jurisdictional dispute therefore turns on the constitutional question, and Mylan makes no argument against jurisdiction other than one based on due-process standards. We decide the question de novo, applying our own (not regional-circuit) law. Merial Ltd. v. Cipla Ltd., 681 F.3d 1283, 1292 (Fed. Cir. 2012); Akro Corp. v. Luker, 45 F.3d 1541, 1543 (Fed. Cir. 1995).

          A court may exercise specific personal jurisdiction without violating the Due Process Clause when the defendant " ha[s] certain minimum contacts with [the forum] such that the maintenance of the suit does not offend 'traditional notions of fair play and substantial justice.'" Int'l Shoe Co. v. Washington, 326 U.S. 310, 316, 66 S.Ct. 154, 90 L.Ed. 95 (1945). The minimum-contacts requirement focuses on whether " the defendant's suit-related conduct . . . create[s] a substantial connection with the forum State." Walden v. Fiore, 134 S.Ct. 1115, 1121, 188 L.Ed.2d 12');">188 L.Ed.2d 12 (2014). What conduct is suit-related depends on " the relationship among the defendant, the forum, and the litigation," Keeton v. Hustler Magazine, Inc., 465 U.S. 770, 775, 104 S.Ct. 1473, 79 L.Ed.2d 790 (1984), including specifically the nature of the claim asserted. See Calder v. Jones, 465 U.S. 783, 789-90, 104 S.Ct. 1482, 79 L.Ed.2d 804 (1984); Walden, 134 S.Ct. at 1124 (" The strength of [the defendant's] connection [to California in Calder] was largely a function of the nature of the libel tort." ). In a formulation worded to address suits for retrospective relief based on past acts, the Supreme Court has said that the minimum-contacts requirement is met when the defendant " purposefully directed" activities at the forum, " and the litigation results from alleged injuries that 'arise out of or relate to' those activities." Burger King Corp. v. Rudzewicz, 471 U.S. 462, 472-73, 105 S.Ct. 2174, 85 L.Ed.2d 528 (1985) (citations omitted); see Grober v. Mako Prods., Inc., 686 F.3d 1335, 1346 (Fed. Cir. 2012). Here, Mylan has taken the costly, significant step of applying to the FDA for approval to engage in future activities--including the marketing of its generic drugs--that will be purposefully directed at Delaware (and, it is undisputed, elsewhere). If Mylan had already begun its deliberate marketing of these drugs in Delaware, there is no doubt that it could be sued for infringement in Delaware. Its Delaware sales would be acts committed in the State that are wrongful--if the plaintiffs here are right about infringement and validity--and would concretely injure Acorda and AstraZeneca in the State by displacing some of their Delaware sales and likely lowering the price they could charge there. See World-Wide Volkswagen Corp. v. Woodson, 444 U.S. 286, 297, 100 S.Ct. 559, 62 L.Ed.2d 490 (1980); Beverly Hills Fan Co. v. Royal Sovereign Corp.,

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21 F.3d 1558, 1565-66 (Fed. Cir. 1994). In our view, the minimum-contacts standard is satisfied by the particular actions Mylan has already taken--its ANDA filings--for the purpose of engaging in that injury-causing and allegedly wrongful marketing conduct in Delaware.

         Mylan's ANDA conduct is " suit-related" and has a " substantial connection" with Delaware, Walden, 134 S.Ct. at 1121, because the ANDA filings are tightly tied, in purpose and planned effect, to the deliberate making of sales in Delaware (at least) and the suit is about whether that in-State activity will infringe valid patents. Thus, Mylan's ANDA filings constitute formal acts that reliably indicate plans to engage in marketing of the proposed generic drugs. Delaware is undisputedly a State where Mylan will engage in that marketing if the ANDAs are approved. And the marketing in Delaware that Mylan plans is suit-related: the suits over patent validity and coverage will directly affect when the ANDA can be approved to allow Mylan's Delaware marketing and when such marketing can lawfully take place. See 21 U.S.C. § 355(j)(5)(B).

          The Hatch--Waxman Act 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. In 35 U.S.C. § 271(e)(2), Congress declared the ANDA filing to be what has been called an " artificial act of infringement," allowing the brand-name manufacturer to sue the ANDA filer to litigate patent validity and coverage. Eli Lilly & Co. v. Medtronic, Inc., 496 U.S. 661, 678, 110 S.Ct. 2683, 110 L.Ed.2d 605 (1990). In so doing, Congress stressed the ANDA filer's " purpose . . . to obtain approval under such Act to engage in the commercial manufacture, use, or sale of a drug . . . claimed in a patent or the use of which is claimed in a patent before the expiration of such patent," 35 U.S.C. § 271(e)(2)(A)--concrete, non-artificial acts of infringement. The relief available in such a suit, moreover, is focused on preventing or remedying the distinctly non-artificial infringing activities that threaten commercial harm: an order to delay the ANDA approval that is a precondition to marketing; an injunction to prevent commercial manufacture, sale, importation, etc.; and monetary relief for such commercial activities in the past. Id. § 271(e)(4).

         Likewise, an ANDA filer's paragraph IV certification regarding patents addresses the real-world actions for which approval is sought--specifically, whether those actions would infringe. 21 U.S.C. § 355(j)(2)(A)(vii)(IV) (certification states that patent will not be infringed " by the manufacture, use, or sale of the new drug for which the application is submitted" ); 21 C.F.R. § 314.94(a)(12)(i)(A)(4) (same). This court has long recognized that the infringement inquiry called for by § 271(e)(2) is " whether, if a particular drug were put on the market, it would infringe the relevant patent" in the usual, non-artificial sense. Bristol-Myers Squibb Co. v. Royce Labs., Inc., 69 F.3d 1130, 1135 (Fed. Cir. 1995); seeSunovion Pharms., Inc. v. Teva Pharms. USA, Inc., 731 F.3d 1271, 1278-79 (Fed. Cir. 2013) (question is whether the conduct for which filer seeks approval would infringe); see alsoEli Lilly & Co., 496 U.S. at 678 (ยง 271(e)(2)'s " act of infringement . . . consists ...

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