Document ID: s3://data.kl3m.ai/documents/govinfo/USCOURTS/USCOURTS-ca13-15-01460/USCOURTS-ca13-15-01460-0/pdf.json

Parties Involved:
Astrazeneca AB
Appellee
Mylan Pharmaceuticals Inc.
Appellant

Document Text:

United States Court of Appeals 

for the Federal Circuit ______________________ 

ACORDA THERAPEUTICS INC., ALKERMES 

PHARMA IRELAND LIMITED,

Plaintiffs-Appellees

v.

MYLAN PHARMACEUTICALS INC., MYLAN INC.,

Defendants-Appellants

______________________ 

2015-1456

______________________ 

Appeal from the United States District Court for the 

District of Delaware in No. 1:14-cv-00935-LPS, Chief 

Judge Leonard P. Stark.

-----------------------------------------------------------------

ASTRAZENECA AB,

Plaintiff-Appellee

v.

MYLAN PHARMACEUTICALS INC.,

Defendant-Appellant

______________________ 

2015-1460

______________________ 

Case: 15-1460 Document: 101-2 Page: 1 Filed: 03/18/2016
2 ACORDA THERAPEUTICS INC. v. MYLAN PHARM. INC. 

Appeal from the United States District Court for the 

District of Delaware in Nos. 1:14-cv-00664-GMS, 1:14-cv00696-GMS, Judge Gregory M. Sleet.

______________________ 

Decided: March 18, 2016 

______________________ 

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. 

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ACORDA THERAPEUTICS INC. v. MYLAN PHARM. INC. 3

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 for the court filed by Circuit Judge TARANTO. 

Opinion concurring in the judgment filed by Circuit Judge

O’MALLEY. 

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 

Case: 15-1460 Document: 101-2 Page: 3 Filed: 03/18/2016
4 ACORDA THERAPEUTICS INC. v. MYLAN PHARM. INC. 

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.

BACKGROUND

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. 

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ACORDA THERAPEUTICS INC. v. MYLAN PHARM. INC. 5

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 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 regis-

 

1 Acorda and Alkermes also sued Mylan’s parent 

corporation, Mylan Inc., but the parties voluntarily dismissed Mylan Inc. without prejudice.

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6 ACORDA THERAPEUTICS INC. v. MYLAN PHARM. INC. 

tration 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 Pharm. Inc., 78 F. 

Supp. 3d 572, 593–95 (D. Del. 2015); AstraZeneca AB v. 

Mylan Pharm., 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. 

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ACORDA THERAPEUTICS INC. v. MYLAN PHARM. INC. 7

Co. v. Gold Issue Mining & Milling Co., 243 U.S. 93 

(1917), in light of later decisions such as Daimler AG v. 

Bauman, 134 S. Ct. 746 (2014). See Acorda, 78 F. Supp. 

3d at 587–90; AstraZeneca, 72 F. Supp. 3d at 556–57. But 

the latter disagreement 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).

DISCUSSION

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 (1945). 

The minimum-contacts requirement focuses on whether 

“the defendant’s suit-related conduct . . . create[s] a 

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8 ACORDA THERAPEUTICS INC. v. MYLAN PHARM. INC. 

substantial connection with the forum State.” Walden v. 

Fiore, 134 S. Ct. 1115, 1121 (2014). What conduct is suitrelated depends on “the relationship among the defendant, the forum, and the litigation,” Keeton v. Hustler 

Magazine, Inc., 465 U.S. 770, 775 (1984), including specifically the nature of the claim asserted. See Calder v. 

Jones, 465 U.S. 783, 789–90 (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 (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 (1980); Beverly Hills 

Fan Co. v. Royal Sovereign Corp., 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 

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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 (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 marCase: 15-1460 Document: 101-2 Page: 9 Filed: 03/18/2016
10 ACORDA THERAPEUTICS INC. v. MYLAN PHARM. INC. 

keting; 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); see 

Sunovion Pharm., Inc. v. Teva Pharm. USA, Inc., 731 

F.3d 1271, 1278–79 (Fed. Cir. 2013) (question is whether 

the conduct for which filer seeks approval would infringe); 

see also Eli Lilly & Co., 496 U.S. at 678 (§ 271(e)(2)’s “act 

of infringement . . . consists of submitting an ANDA . . . 

containing . . . [a] certification that is in error as to 

whether commercial manufacture, use, or sale of the new 

drug (none of which, of course, has actually occurred) 

violates the relevant patent.”). 

Notably, Congress did not authorize a patent-owning 

brand-name manufacturer to bring a suit over patent 

validity or coverage just because someone, no matter who, 

has called the manufacturer’s patent into question by 

declaring in some forum—to the FDA, to investors, to the 

public—that the patent is invalid or of limited scope. 

Congress added § 271(e)(2) as a special means of litigating 

patent scope and validity only when such a declaration 

has been made by an ANDA filer—which has, by its filing, 

confirmed its plan to commit real-world acts that would 

make it liable for infringement if it commits them without 

the patentees’ permission and it is wrong in its challenges 

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to patent scope or validity. Congress also added a provision that confers on the ANDA filer alone a special right 

to seek a declaratory judgment regarding patent scope 

and validity if the NDA holder or patent owner does not 

file suit first. 35 U.S.C. § 271(e)(5). Those statutory 

provisions treat the ANDA filer as distinctive, and what 

distinguishes it is that it has, by its filing, reliably confirmed a plan to engage in real-world marketing. 

All of the parties acknowledged as much at oral argument. Acorda Oral Arg. at 48:32–48:48, 49:18–49:27 

(Mylan), 22:59–23:47 (Acorda); AstraZeneca Oral Arg. at 

21:57–22:32 (AstraZeneca). And the economic realities of 

preparing an ANDA confirm that filing realistically 

establishes a plan to market. The current fee for filing 

the ANDA itself is $76,030. Generic Drug User Fee—

Abbreviated New Drug Application, Prior Approval Supplement, Drug Master File, Final Dosage Form Facility, 

and Active Pharmaceutical Ingredient Facility Fee Rates 

for Fiscal Year 2016, 80 Fed. Reg. 46,015-01, 46,016 (Aug. 

3, 2015). The applicant must show bioequivalence of its 

proposed drug to the drug listed in the NDA, 21 U.S.C. 

§ 355(j)(2)(A)(iv), and that showing, along with other 

requirements for approval of an ANDA, commonly requires costly research, see, e.g., Fiona M. Scott Morton, 

Entry Decisions in the Generic Pharmaceutical Industry, 

30 RAND J. Econ. 421, 423 (1999) (“Interviews with FDA 

officials and several generic pharmaceutical managers 

generated estimated costs of filing an ANDA of $250,000 

to $20 million.”); Jeremy A. Greene, Generic: The Unbranding of Modern Medicine 124 (2014) (estimating the 

cost for measuring bioequivalence of Valium tablets, 

which requires nearly two thousand blood assays on 

human subjects over sixteen days, at $75,000–$125,000). 

The applicant must also identify “the facilities and controls used for[] the manufacture, processing, and packing 

of [its proposed] drug,” 21 U.S.C. § 355(b)(1)(D); 21 C.F.R. 

§ 314.50(d)(1)(ii)(a), and certify that its facilities comply 

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12 ACORDA THERAPEUTICS INC. v. MYLAN PHARM. INC. 

with the extensive good-manufacturing practices detailed 

in 21 C.F.R. pts. 210, 211, see FDA Form 356h. The FDA 

will inspect each facility to “evaluate whether the site is 

able to reliably perform intended operation(s) at a commercial scale.” Guidance for Industry: ANDA Submissions—Content and Format of Abbreviated New Drug 

Applications 4 n.11. The magnitude and costs of the work 

required before the ANDA is filed soundly link the ANDA 

filing to the filer’s entry into the market to compete with 

the brand-name manufacturer if approval is obtained.

We have emphasized the link in several cases where 

we have discussed why the litigation authorized by 

§ 271(e)(2) and (5) meets Article III’s requirement of a 

case or controversy. We have pointed to the future realworld market acts as sufficiently connected to the ANDA 

that triggers the litigation. See Apotex, Inc. v. Daiichi 

Sankyo, Inc., 781 F.3d 1356, 1365 (Fed. Cir. 2015) (“When 

a generic manufacturer seeks to enter the market, the 

concrete stakes are the market sales upon entry.”); Caraco 

Pharm. Labs., Ltd. v. Forest Labs., Inc., 527 F.3d 1278, 

1292 (Fed. Cir. 2008) (explaining that “exclud[ing] noninfringing generic drugs from the market” is the factual 

injury that gives rise to a case or controversy). We have 

noted that Congress deemed the ANDA filing to have a 

non-speculative causal connection to the ANDA filer’s 

future infliction of real-world market injury on the patent 

holder and that Congress may “articulate chains of causation that will give rise to a case or controversy where none 

existed before.” Massachusetts v. EPA, 549 U.S. 497, 516 

(2007); see Apotex, 781 F.3d at 1365; Sandoz Inc. v. Amgen 

Inc., 773 F.3d 1274, 1281 (Fed. Cir. 2014) (Congress may 

“effectively creat[e] justiciability that attenuation concerns would otherwise preclude”); Consumer Watchdog v. 

Wis. Alumni Research Found., 753 F.3d 1258, 1261 (Fed. 

Cir. 2014). The Article III analysis thus confirms the 

closeness of the connection between Mylan’s ANDA filings 

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and the marketing activities for which Mylan, by those 

filings, seeks approval.

Those activities will unquestionably take place in 

Delaware (at least). The subject of the cases before us is 

whether those activities will infringe valid patents and 

should be stopped under the remedial provisions of the 

Hatch–Waxman Act. Mylan’s ANDA filings, including its 

certifications regarding the patents at issue here, are thus 

suit-related, and they have a substantial connection with 

Delaware because they reliably, non-speculatively predict

Delaware activities by Mylan.

In arguing against this application of due-process 

standards, Mylan does not meaningfully develop an 

argument that a rigid past/future dividing line governs 

the minimum-contacts standard. Specifically, Mylan does 

not show that a State is forbidden to exercise its judicial 

power to prevent a defendant’s planned future conduct in 

the State, but must wait until the conduct occurs. Such a 

rule would run counter to the legal tradition of injunctive 

actions to prevent a defendant’s planned, non-speculative

harmful conduct before it occurs. See United States v. W.

T. Grant Co., 345 U.S. 629, 633 (1953) (“The purpose of an 

injunction is to prevent future violations, . . . and, of 

course, it can be utilized even without a showing of past 

wrongs.”); 43A C.J.S. Injunctions § 49 (2015); 11A Charles 

Alan Wright, Arthur R. Miller, Mary Kay Kane, Richard 

L. Marcus, & Adam N. Steinman, Federal Practice & 

Procedure § 2948.1 (3d ed. 2015). As long as the connection to the planned acts is close enough, the subject of 

such actions readily fits the terms of the minimumcontacts standard—conduct purposefully directed at the 

State that gives rise and is related to the suit. A State’s 

exercise of jurisdiction over a defendant planning such 

conduct can hardly come as a surprise to the defendant 

and does nothing to “offend ‘traditional notions of fair 

play and substantial justice.’” Int’l Shoe, 326 U.S. at 316 

(citation omitted); see also Burger King, 471 U.S. at 479 

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14 ACORDA THERAPEUTICS INC. v. MYLAN PHARM. INC. 

(explaining that personal jurisdiction should realistically 

consider the object of the dispute and noting that “contemplated future consequences” can play a role in the 

inquiry); Roth v. Garcia Marquez, 942 F.2d 617, 622 (9th 

Cir. 1991) (finding purposeful availment to support specific personal jurisdiction over defendant in a contract 

dispute because “the contract [at issue] concerned a film, 

most of the work for which would have been performed in 

[the forum]”). 

For those reasons, it suffices for Delaware to meet the 

minimum-contacts requirement in the present cases that 

Mylan’s ANDA filings and its distribution channels 

establish that Mylan plans to market its proposed drugs 

in Delaware and the lawsuit is about patent constraints 

on such in-State marketing. And we are not barred from 

adopting that common-sense conclusion by this court’s 

decision in Zeneca Ltd. v. Mylan Pharmaceuticals, Inc., 

173 F.3d 829 (Fed. Cir. 1999). That case was decided 

without any majority opinion, and neither of the two 

single-judge opinions (Judge Rich dissented without 

opinion) addresses whether the location of the ANDA 

filer’s future sales could support specific personal jurisdiction over the filer in the § 271(e)(2) suit, so Zeneca is not 

precedent on that issue. See Automated Merchandising 

Sys., Inc. v. Lee, 782 F.3d 1376, 1381 (Fed. Cir. 2015); 

Lumbermens Mut. Cas. Co. v. United States, 654 F.3d 

1305, 1317 n.10 (Fed. Cir. 2011). The issue was not

presented to the court in Zeneca. The parties consistently 

stated in their briefs that the only contact with the forum 

at issue was the act of making the ANDA filing (at the 

FDA’s office in Maryland). Brief for Defendant-Appellant 

Mylan Pharmaceuticals, Inc. at 2, Zeneca (No. 97-1477), 

1997 WL 33545105; Brief for Plaintiff-Appellee Zeneca 

Limited at 11, Zeneca (No. 97-1477), 1997 WL 33545104. 

That limit on the issue before this court was reflected in 

the question certified for interlocutory appeal. See

Zeneca, 173 F.3d at 830–31 (Gajarsa, J., concurring in the 

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judgment of reversal). In deciding only that issue, this 

court in Zeneca simply did not examine whether planned 

marketing in Maryland would have supported personal 

jurisdiction there. 

Here, to reiterate, Mylan seeks approval to sell its generic drugs throughout the United States, including in 

Delaware, and it is undisputed that Mylan plans to direct 

sales of its generic drugs into Delaware. The complaints 

in these cases allege that Mylan’s generic drugs would be 

distributed and sold in Delaware and that Mylan intends 

to commercially manufacture, use, and sell the generics 

upon receiving FDA approval. As Mylan admits, it develops drugs for the entire U.S. market and does some business in every State, either directly or indirectly. 

Pursuant to Del. Code Ann. tit. 8, §§ 371(b)(2), 376(a), 

Mylan has registered to do business in Delaware and 

appointed an agent to accept service of process there. 

Mylan indicated in its certificate of registration that it 

intends to engage in “[p]harmaceutical manufacturing, 

distribution and sales” in Delaware, Acorda J.A. 79; 

AstraZeneca J.A. 65, and Mylan registered with the 

Delaware Board of Pharmacy as a licensed “PharmacyWholesale” and a “Distributor/Manufacturer CSR.” And 

even if Mylan does not sell its drugs directly into Delaware, it has a network of independent wholesalers and 

distributors with which it contracts to market the drugs 

in Delaware. Such directing of sales into Delaware is 

sufficient for minimum contacts. See Beverly Hills Fan, 

21 F.3d at 1565 (finding purposeful contacts where “the 

accused [infringing device] arrived in Virginia through 

defendants’ purposeful shipment . . . through an established distribution channel”).

One point remains. A finding of minimum contacts 

does not end the due-process inquiry—let alone any nonconstitutional venue inquiries—into whether a case 

properly remains in a forum. Even if a defendant has 

minimum suit-related contacts with a State, the defendCase: 15-1460 Document: 101-2 Page: 15 Filed: 03/18/2016
16 ACORDA THERAPEUTICS INC. v. MYLAN PHARM. INC. 

ant may defeat specific personal jurisdiction by sufficiently demonstrating that other considerations render jurisdiction unreasonable. See Burger King, 471 U.S. at 477. 

The Supreme Court has identified a number of factors to 

consider, including “the burden on the defendant,” “the 

forum State’s interest in adjudicating the dispute,” “the 

plaintiff’s interest in obtaining convenient and effective 

relief,” and “the interstate judicial system’s interest in 

obtaining the most efficient resolution of controversies.” 

World-Wide Volkswagen, 444 U.S. at 292. But Mylan 

cannot show that those due-process factors weigh against

litigating the present cases in Delaware.

The burden on Mylan will be at most modest, as 

Mylan, a large generic manufacturer, has litigated many 

ANDA lawsuits in Delaware, including some that it 

initiated. Delaware has an interest in providing a forum 

to resolve the disputes before us because they involve the 

pricing and sale of products in Delaware and harms to 

firms doing business in Delaware, some of them incorporated or with principal places of business in Delaware. 

And upholding personal jurisdiction will serve the interests of the plaintiffs and the judicial system in efficient 

resolution of litigation, because multiple lawsuits against 

other generic manufacturers on the same patents are 

pending in Delaware. Indeed, Mylan sent its required 

notice to Acorda after those actions had already begun. In 

these cases, there is no substantial argument that considerations of unfairness override the minimum-contacts 

basis for Delaware’s exercise of specific personal jurisdiction over Mylan. 

CONCLUSION

The decisions of the district court that Mylan is 

subject to specific personal jurisdiction in the district 

court for Delaware are affirmed. 

AFFIRMED

Case: 15-1460 Document: 101-2 Page: 16 Filed: 03/18/2016
United States Court of Appeals 

for the Federal Circuit ______________________ 

ACORDA THERAPEUTICS INC., ALKERMES 

PHARMA IRELAND LIMITED,

Plaintiffs-Appellees

v.

MYLAN PHARMACEUTICALS INC., MYLAN INC.,

Defendants-Appellants

______________________ 

2015-1456

______________________ 

Appeal from the United States District Court for the 

District of Delaware in No. 1:14-cv-00935-LPS, Chief 

Judge Leonard P. Stark.

-----------------------------------------------------------------

ASTRAZENECA AB,

Plaintiff-Appellee

v.

MYLAN PHARMACEUTICALS INC.,

Defendant-Appellant

______________________ 

2015-1460

______________________ 

Case: 15-1460 Document: 101-2 Page: 17 Filed: 03/18/2016
2 ACORDA THERAPEUTICS INC. v. MYLAN PHARM. INC. 

Appeal from the United States District Court for the 

District of Delaware in Nos. 1:14-cv-00664-GMS, 1:14-cv00696-GMS, Judge Gregory M. Sleet.

______________________ 

O’MALLEY, Circuit Judge, concurring.

I agree that the district judges in these appeals have

jurisdiction to hear the cases before them. I write separately because I believe we should reach the question of 

general jurisdiction, which the parties raise and the 

district judges decided. The specific jurisdiction issue, 

which the majority exclusively decides, is a more difficult 

question to resolve than the question of the continuing 

precedential effect of the line of Supreme Court authority 

articulated most clearly in Pennsylvania Fire Insurance

Co. of Philadelphia v. Gold Issue Mining & Milling Co., 

243 U.S. 93 (1917). The parties dispute a host of factual 

questions regarding the specific jurisdiction issue, including whether and to what extent Mylan ultimately may be 

authorized to—or decide to—market generic drugs in 

Delaware. And, as I explain below, I would find specific 

jurisdiction over Mylan in these cases under a different 

legal theory than employed by the majority, evidencing

the complexity of the question posed in the circumstances 

created by operation of the Drug Price Competition and 

Patent Term Restoration Act, Pub. L. No. 98-417, 98 Stat. 

1585 (1984), commonly known as the Hatch–Waxman Act.

While there is no requirement that a court consider 

general jurisdiction before, or in addition to, its consideration of specific jurisdiction, the Supreme Court has given 

some guidance about the sequencing of jurisdictional 

decisions. In Steel Co. v. Citizens for a Better Environment, 523 U.S. 83 (1998) and Ruhrgas AG v. Marathon 

Oil Co., 526 U.S. 574 (1999), the Court reiterated the 

longstanding principle that, “[w]ithout jurisdiction the 

court cannot proceed at all in any cause. Jurisdiction is 

power to declare the law, and when it ceases to exist, the 

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ACORDA THERAPEUTICS INC. v. MYLAN PHARM. INC. 3

only function remaining to the court is that of announcing 

the fact and dismissing the cause.” 523 U.S. at 94 (quoting Ex parte McCardle, 74 U.S. (7 Wall.) 506, 514 (1868)) 

(internal quotation marks omitted). Without jurisdiction, 

a court may not proceed to dispose of a case on the merits. 

Ruhrgas addressed the particular question of whether, “[i]f, as Steel Co. held, jurisdiction generally must 

precede merits in dispositional order, must subject-matter 

jurisdiction precede personal jurisdiction on the decisional 

line? Or, do federal district courts have discretion to 

avoid a difficult question of subject-matter jurisdiction 

when the absence of personal jurisdiction is the surer 

ground?” 526 U.S. at 577–78. Rather than dictate a 

required order, the Court found “no unyielding jurisdictional hierarchy” between personal jurisdiction and 

subject-matter jurisdiction. Id. at 578. Yet it did endorse 

addressing more straightforward jurisdictional questions

first. The Court found that, when “a district court has 

before it a straightforward personal jurisdiction issue 

presenting no complex question of state law, and the 

alleged defect in subject-matter jurisdiction raises a 

difficult and novel question, the court does not abuse its 

discretion by turning directly to personal jurisdiction.” Id.

at 588. So too here, when a case may be decided on the 

grounds of either general or specific personal jurisdiction, 

I believe we should begin with the more straightforward 

of the two.

As Ockham’s Razor advises, the simpler path is usually best. See, e.g., Awkal v. Mitchell, 613 F.3d 629, 655 

(6th Cir. 2010) (Boyce, J., dissenting) (“At some point, 

Ockham’s Razor must apply—the simplest answer is 

usually the correct one.”); Commodity Futures Trading 

Comm’n v. Zelener, 373 F.3d 861, 868 (7th Cir. 2004) 

(Easterbrook, J.) (“Best to take Occam’s Razor and slice 

off needless complexity.”). The majority finds specific 

personal jurisdiction because “Mylan’s ANDA filings 

constitute formal acts that reliably indicate plans to 

Case: 15-1460 Document: 101-2 Page: 19 Filed: 03/18/2016
4 ACORDA THERAPEUTICS INC. v. MYLAN PHARM. INC. 

engage in marketing of the proposed generic drugs” in 

Delaware, Maj. Op. at 9, while expressly declining to 

discuss general personal jurisdiction, id. at 4. In this 

case, however, because I believe that the question of 

general jurisdiction is more straightforward—as it merely 

requires acknowledging a century-old line of Supreme 

Court precedent—I believe it should be addressed first. 

And, to the extent this court finds it necessary to venture 

into the more fact-intensive morass of specific jurisdiction, 

I believe the effects-based test of Calder v. Jones, 465 U.S. 

783 (1984), provides a simpler underpinning for resolution, one that does not require reliance on a defendant’s 

“planned future conduct in the State.” Maj. Op. at 13. 

DISCUSSION

A. GENERAL JURISDICTION

The requirement that a court have personal jurisdiction over a defendant before it may act “represents a 

restriction on judicial power not as a matter of sovereignty, but as a matter of individual liberty.” Ins. Corp. of Ir.

v. Compagnie des Bauxites de Guinee, 456 U.S. 694, 702 

(1982). As such, personal jurisdiction is a “‘personal 

privilege respecting the venue, or place of suit, which [a 

defendant] may assert, or may waive, at his election.’ 

Being a privilege it may be lost.” Neirbo Co. v. Bethlehem 

Shipbuilding Corp., 308 U.S. 165, 168 (1939) (quoting 

Commercial Cas. Ins. Co. v. Consol. Stone Co., 278 U.S. 

177, 179 (1929)). 

A defendant may, thus, consent to personal jurisdiction and thereby waive its right to contest it. “[B]ecause 

the personal jurisdiction requirement is a waivable right, 

there are a ‘variety of legal arrangements’ by which a 

litigant may give ‘express or implied consent to the personal jurisdiction of the court.”’ Burger King Corp. v. 

Rudzewicz, 471 U.S. 462, 472 n.14 (1985) (citing Ins. 

Corp. of Ir., 456 U.S. at 703). A defendant may consent to 

personal jurisdiction explicitly, by stipulating in advance 

Case: 15-1460 Document: 101-2 Page: 20 Filed: 03/18/2016
ACORDA THERAPEUTICS INC. v. MYLAN PHARM. INC. 5

to litigate its claims in a particular jurisdiction through a 

forum selection clause or some other agreement. See Nat’l

Equip. Rental, Ltd. v. Szukhent, 375 U.S. 311, 315–16

(1964) (“[I]t is settled . . . that parties to a contract may 

agree in advance to submit to the jurisdiction of a given 

court . . . .”). A party may also signal consent to personal 

jurisdiction through its actions, for example, by appearing 

in court and arguing the merits of the case. See Ins. Corp. 

of Ir., 456 U.S. at 703 (“[A]n individual may submit to the 

jurisdiction of the court by appearance.”). At issue in 

these appeals is, among other things, whether compliance 

with a state statute that requires registration and the 

appointment of an in-state agent for service of process in 

order to conduct business in that state remains a valid 

form of express consent to general personal jurisdiction 

after the Supreme Court’s decision in Daimler AG v. 

Bauman, 134 S. Ct. 746 (2014). Delaware employs just 

such a scheme.

In particular, Delaware requires foreign corporations 

to register to do business in Delaware and to appoint an 

agent for service of process. Del. Code Ann. tit. 8, 

§ 371(b)(2)(i) (prohibiting a foreign corporation from doing 

business in Delaware until it registers with the Secretary 

of State and files “[a] statement . . . setting forth (i) the 

name and address of its registered agent” in Delaware). 

According to the Delaware Code, “[a]ll process issued out 

of any [Delaware] court . . . may be served on the registered agent of the corporation designated in accordance 

with § 371.” Id. § 376(a). Foreign corporations that do 

business in Delaware without registering face statutory 

fines for violating the mandatory registration requirement. Id. § 378.

In Sternberg v. O’Neil, 550 A.2d 1105 (Del. 1988), the 

Delaware Supreme Court held that compliance with 

Delaware’s registration statute constitutes consent to 

general personal jurisdiction. That court held that, “when 

[a corporation] qualified as a foreign corporation, pursuCase: 15-1460 Document: 101-2 Page: 21 Filed: 03/18/2016
6 ACORDA THERAPEUTICS INC. v. MYLAN PHARM. INC. 

ant to 8 Del.C. § 371, and appointed a registered agent for 

the service of process, pursuant to 8 Del.C. § 376, [that 

corporation] consented to the exercise of general jurisdiction by the Courts of Delaware.” Sternberg, 550 A.2d at

1116. In support of its holding, the Delaware Supreme 

Court cited to Pennsylvania Fire Insurance Co. v. Gold 

Issue Mining & Milling Co., 243 U.S. 93, 96 (1917): 

“[W]hen a power actually is conferred by a document, the 

party executing it takes the risk of the interpretation that 

may be put upon it by the courts.” Sternberg, 550 A.2d at

1116 n.19; see also id. at 1113–15 (finding that the foreign 

corporation’s “consent to the general personal jurisdiction 

of Delaware courts by qualifying as a foreign corporation 

satisfies due process” and does not constitute an undue 

burden on interstate commerce). 

Chief Judge Stark (in the Acorda case) and Judge 

Sleet (in the AstraZeneca case) came to different conclusions on whether compliance with a state’s registration 

statute that requires appointment of a registered agent 

for service of process continues to constitute a valid form 

of consent to general personal jurisdiction after Daimler. 

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

78 F. Supp. 3d 572, 583–92 (D. Del. 2015) (holding that, 

“Daimler does not eliminate consent as a basis for a state 

to establish general jurisdiction over a corporation which 

has appointed an agent for service of process in that state, 

as is required as part of registering to do business in that 

state”), with AstraZeneca AB v. Mylan Pharm., Inc., 72 F. 

Supp. 3d 549, 555–58 (D. Del. 2014) (holding that, “[i]n 

light of the holding in Daimler, the court finds that 

Mylan’s compliance with Delaware’s registration statutes—mandatory for doing business within the state—

cannot constitute consent to jurisdiction, and the Delaware Supreme Court’s decision in Sternberg can no longer 

be said to comport with federal due process”). I agree 

with Chief Judge Stark that Daimler did not overrule the 

line of Supreme Court authority establishing that a 

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ACORDA THERAPEUTICS INC. v. MYLAN PHARM. INC. 7

corporation may consent to jurisdiction over its person by 

choosing to comply with a state’s registration statute.

That line began with Ex parte Schollenberger, 96 U.S. 

(6 Otto) 369 (1877). In Schollenberger, the Supreme 

Court first held that a state legislature may require a 

foreign corporation to consent to general personal jurisdiction as a condition of being granted the right to do 

business in that state: 

[I]f the legislature of a State requires a foreign 

corporation to consent to be “found” within its territory, for the purpose of the service of process in a 

suit, as a condition to doing business in the State, 

and the corporation does so consent, the fact that 

it is found gives the jurisdiction, notwithstanding 

the finding was procured by consent. 

Id. at 377. In St. Clair v. Cox, 106 U.S. (16 Otto) 350

(1882), the Court discussed the problems with the “doctrine of exemption of a corporation from suit in a state 

other than that of its creation.” Id. at 355. Given “[t]he 

great increase in the number of corporations of late years, 

and the immense extent of their business,” the Court 

found that such jurisdictional exemptions led to “inconvenience and injustice.” Id. In response to those issues, 

“the legislatures of several states interposed and provided 

for service of process on officers and agents of foreign 

corporations doing business therein.” Id. The Court 

found “no sound reason why, to the extent of their agency, 

[officers and agents of foreign corporations] should not be 

equally deemed to represent [the foreign corporation] in 

the states for which they are respectively appointed when 

it is called to legal responsibility for their transactions.” 

Id. As such:

[a] corporation of one state cannot do business in 

another state without the latter’s consent, express 

or implied, and that consent may be accompanied 

with such conditions as it may think proper to imCase: 15-1460 Document: 101-2 Page: 23 Filed: 03/18/2016
8 ACORDA THERAPEUTICS INC. v. MYLAN PHARM. INC. 

pose. . . . The state may, therefore, impose as a 

condition upon which a foreign corporation shall 

be permitted to do business within her limits, that 

it shall stipulate that in any litigation arising out 

of its transactions in the state, it will accept as 

sufficient the service of process on its agents or 

persons specially designated, and the condition 

would be eminently fit and just.

Id. at 356. This line of reasoning continued in Pennsylvania Fire, the key, though not final, case addressing the 

question.

In Pennsylvania Fire, the Court affirmed that it had 

“little doubt” that the appointment of an agent by a 

foreign corporation for service of process could subject it 

to general personal jurisdiction. 243 U.S. at 95. In that 

case, the defendant was a foreign insurance company who 

had obtained a license to do business in Missouri, and, in 

accordance with the law of Missouri, “filed with the superintendent of the insurance department a power of attorney consenting that service of process upon the 

superintendent should be deemed personal service upon 

the company so long as it should have any liabilities 

outstanding in the state.” Id. at 94. The defendant 

argued that “such service was insufficient except in suits 

upon Missouri contracts, and that if the statute were 

construed to govern the present case, it encountered the 

14th Amendment by denying to the defendant due process 

of law.” Id. at 94–95. A unanimous Court disagreed with 

the defendant, holding that, “when a power is actually 

conferred by a document, the party executing it takes the 

risk of the interpretation that may be put upon it by the 

courts. The execution was the defendant’s voluntary act.” 

Id. at 96.

In the almost 100 years since the Supreme Court decided Pennsylvania Fire, it has had ample opportunity to 

reconsider its holding. Yet each time the issue arose, the 

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ACORDA THERAPEUTICS INC. v. MYLAN PHARM. INC. 9

Supreme Court reaffirmed that registration statutes, 

mandatory for doing business, could confer jurisdiction 

through consent depending on the interpretation given to 

those state statutes by state courts. See Robert Mitchell 

Furniture Co. v. Selden Breck Constr. Co., 257 U.S. 213, 

216 (1921) (finding no jurisdiction over a foreign corporation when the compliance statute was limited to “liability 

incurred within the State,” but noting that “the state law 

[could] either expressly or by local construction give[] to 

the appointment a larger scope”); Louisville & N.R. Co. v. 

Chatters, 279 U.S. 320, 329 (1929) (holding “that, in the 

absence of an authoritative state decision giving a narrower scope to the power of attorney filed under the state 

statute, it operates as a consent to suit” (citing Pa. Fire, 

243 U.S. 93)); Neirbo, 308 U.S. at 175 (holding that, “[a] 

statute calling for [designation of an agent for service of 

process in the forum state] is constitutional, and the 

designation of the agent ‘a voluntary act’” (citing Pa. Fire, 

243 U.S. 93)).

The Supreme Court’s subsequent decisions in International Shoe and Daimler did not overrule this historic and 

oft-affirmed line of binding precedent. Indeed, both cases 

are expressly limited to scenarios that do not involve 

consent to jurisdiction. In International Shoe, the Court 

restricted its discussion to cases where “no consent to be 

sued or authorization to an agent to accept service of 

process has been given.” 326 U.S. at 317 (emphasis 

added). Based on the limitation placed on the reach of 

International Shoe by the Supreme Court itself, after 

International Shoe, numerous circuit courts continued to 

uphold the exercise of general jurisdiction over defendants 

registered to do business in the states at issue, relying on 

the continuing vitality of Pennsylvania Fire. See, e.g., 

King v. Am. Family Mut. Ins. Co., 632 F.3d 570, 576, 578 

(9th Cir. 2011) (“Pennsylvania Fire, Chipman[, Ltd., v. 

Thomas B. Jeffrey Co., 251 U.S. 373 (1920)], and Robert 

Mitchell thus collectively stand for the proposition that 

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10 ACORDA THERAPEUTICS INC. v. MYLAN PHARM. INC. 

federal courts must, subject to federal constitutional 

restraints, look to state statutes and case law in order to 

determine whether a foreign corporation is subject to 

personal jurisdiction in a given case because the corporation has appointed an agent for service of process.”); 

Wenche Siemer v. Learjet Acquisition Corp., 966 F.2d 179, 

183 (5th Cir. 1992) (“No Texas state court decision has 

held that this provision acts as a consent to jurisdiction 

over a corporation in a case such as ours—that is where 

plaintiffs are non-residents and the defendant is not 

conducting substantial activity within the state.”); Bane v. 

Netlink, Inc., 925 F.2d 637, 641 (3d Cir. 1991) (observing 

that “[c]onsent is a traditional basis for assertion of 

jurisdiction long upheld as constitutional”); Knowlton v. 

Allied Van Lines, Inc., 900 F.2d 1196, 1199–1200 (8th Cir. 

1990) (noting that, as interpreted by the Supreme Court 

of Minnesota, “[t]he whole purpose of requiring designation of an agent for service is to make a nonresident 

suable in the local courts”); Holloway v. Wright & Morrissey, Inc., 739 F.2d 695, 697 (1st Cir. 1984) (“It is wellsettled that a corporation that authorizes an agent to 

receive service of process in compliance with the requirements of a state statute, consents to the exercise of personal jurisdiction in any action that is within the scope of 

the agent’s authority.”). And, the Second Restatement 

adopted that same view in 1971. Restatement (Second) of 

Conflict of Laws § 44 (1971) (“A state has power to exercise judicial jurisdiction over a foreign corporation which 

has authorized an agent or a public official to accept 

service of process in actions brought against the corporation in the state as to all causes of action to which the 

authority of the agent or official to accept service extends.”). Daimler did not change the law on this point, 

either. 

There is no discussion of registration statutes in 

Daimler and no citation to Schollenberger, Pennsylvania

Fire, or the cases post-dating those two. Indeed, Daimler

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ACORDA THERAPEUTICS INC. v. MYLAN PHARM. INC. 11

confirms that consent to jurisdiction is an alternative to 

the minimum contacts analysis discussed in that case, 

citing to Perkins v. Benguet Consolidated Mining Co., 342 

U.S. 437 (1952), as “the textbook case of general jurisdiction appropriately exercised over a foreign corporation 

that has not consented to suit in the forum.” 134 S. Ct. at 

755–56 (emphasis added). Thus, Daimler did not impliedly eradicate the distinction between cases involving an 

express consent to general jurisdiction and those analyzing general jurisdiction in the absence of consent; it 

actually maintains it. Notably, the Court had no occasion 

to consider the rule it laid down in Pennsylvania Fire

because California—the state where the action at issue 

was pending—had interpreted its registration statute as 

one that did not, by compliance with it, give rise to consent to personal jurisdiction. The only question the Court 

considered was whether the foreign defendant was subject 

to jurisdiction solely by virtue of its contacts with the 

state, which were unrelated to the cause of action. 

Any argument that Mylan’s express consent to general personal jurisdiction was involuntary, moreover, is 

not well-taken. In Insurance Corporation of Ireland, the 

Supreme Court noted that it “has upheld state procedures 

which find constructive consent to the personal jurisdiction of the state court in the voluntary use of certain state 

procedures.” 456 U.S. at 704 (citing, among other cases, 

Chicago Life Ins. Co. v. Cherry, 244 U.S. 25, 29–30 (1917) 

(“[W]hat acts of the defendant shall be deemed a submission to [a court’s] power is a matter upon which States 

may differ.”)). The relevant inquiry is not whether Mylan 

voluntarily consented to jurisdiction in Delaware, but 

whether it voluntarily elected to do business in Delaware 

and to register and elect an agent for service of process in 

that state. It undoubtedly did.

Notably, Pennsylvania Fire was decided almost 100 

years before Mylan chose to register to do business in 

Delaware. And Sternberg’s interpretation of the registraCase: 15-1460 Document: 101-2 Page: 27 Filed: 03/18/2016
12 ACORDA THERAPEUTICS INC. v. MYLAN PHARM. INC. 

tion statute had been on the books for almost twenty of 

those years. In the face of that legal authority, Mylan 

knowingly chose to register to do business in Delaware, 

thereby accepting the implication of having done so. 

By virtue of the Delaware Supreme Court’s decision in 

Sternberg, the Delaware registration statute falls squarely within the rule of Pennsylvania Fire and its progeny. 

Unless the Supreme Court or Congress overrules this line 

of Supreme Court authority, we are bound to follow it. 

Rodriguez de Quijas v. Shearson/Am. Exp., Inc., 490 U.S. 

477, 484 (1989) (“If a precedent of this Court has direct 

application in a case, yet appears to rest on reasons 

rejected in some other line of decisions, the Court of 

Appeals should follow the case which directly controls, 

leaving to this Court the prerogative of overruling its own 

decisions.”); see also State Oil Co. v. Khan, 522 U.S. 3, 20 

(1997) (Even if a Supreme Court precedent contains many 

“infirmities” and rests upon “wobbly, moth-eaten foundations,” it remains the “Court’s prerogative alone to overrule one of its precedents.”). While there may well be 

reasons why the Supreme Court would choose to overrule 

Pennsylvania Fire—similar to those discussed in Daimler

or others—that is the Court’s prerogative, not ours. 

Accordingly, I would conclude that Mylan is subject to 

general personal jurisdiction in Delaware by virtue of its 

voluntary, express consent to such jurisdiction and end 

our jurisdictional discussion there.1

 

1 One amicus argues that a finding of general personal jurisdiction by virtue of Delaware’s consent-byregistration statute would violate the unconstitutional 

conditions doctrine. See Br. of Amicus Curiae Chamber of 

Commerce 18–21. Because neither party has raised the 

question, however, it is not before us. Even if it were, 

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ACORDA THERAPEUTICS INC. v. MYLAN PHARM. INC. 13

B. SPECIFIC JURISDICTION

A finding that Mylan has consented to general personal jurisdiction obviates the need to consider whether

the district courts here had the authority to exercise 

specific jurisdiction over Mylan in these circumstances. If 

general jurisdiction exists, a court may “hear any and all 

claims against” the parties, whereas specific jurisdiction 

“depends on an ‘affiliatio[n] between the forum and the 

underlying controversy.’” See Goodyear Dunlop Tires 

Operations, S.A. v. Brown, 131 S. Ct. 2846, 2851 (2011)

(citing von Mehren & Trautman, Jurisdiction to Adjudicate: A Suggested Analysis, 79 HARV. L. REV. 1121, 1136 

(1966) (hereinafter von Mehren & Trautman)). “In contrast to general, all-purpose jurisdiction, specific jurisdiction is confined to adjudication of ‘issues deriving from, or 

connected with, the very controversy that establishes 

jurisdiction.’” Id. (citing von Mehren & Trautman).

The majority addresses only specific jurisdiction, and 

finds that it properly can be exercised here. I concur with 

the majority’s judgment, but not entirely with its reasoning. I agree that Mylan is subject to specific jurisdiction 

 

moreover, the Supreme Court has upheld the validity of 

consent-by-registration statutes numerous times since the 

development of the unconstitutional conditions doctrine. 

In Neirbo, the Supreme Court commented that, the decision to strike down the Texas statute at issue, “which not 

merely regulated procedure for suit but sought to deny 

foreign corporations access to the federal courts” was 

“wholly consistent” with the decision in Schollenberger, 

which allowed state legislatures to require foreign corporations to consent to general personal jurisdiction as a 

condition of being granted the right to do business in that 

state. Neirbo, 308 U.S. at 173–74.

Case: 15-1460 Document: 101-2 Page: 29 Filed: 03/18/2016
14 ACORDA THERAPEUTICS INC. v. MYLAN PHARM. INC. 

in Delaware, but I would find specific jurisdiction under 

the Supreme Court’s precedent in Calder v. Jones, 465 

U.S. 783 (1984), and not predicate the exercise of jurisdiction primarily on Mylan’s expressions of future intent.

In Calder, the Court held that, when a defendant engages in intentional acts expressly aimed at the forum 

state, knowing that those acts will harm a potential 

plaintiff residing in that state, the courts in that state do 

not violate due process in exercising jurisdiction over that 

defendant. Id. at 788–90. The defendants in Calder, two 

nonresident journalists, argued that a California court 

could not exercise personal jurisdiction over them for the 

distribution of an “allegedly libelous story concern[ing] 

the California activities of a California resident.” Id. at 

788. The Court analyzed “the relationship among the 

defendant, the forum, and the litigation” to find that 

minimum contacts existed, justifying the exercise of 

jurisdiction over the defendants. Id. (quoting Shaffer v. 

Heitner, 433 U.S. 186, 204 (1977)) (internal quotation 

marks omitted). Specifically, the Court relied upon the 

following facts: 

The allegedly libelous story concerned the California activities of a California resident. It impugned the professionalism of an entertainer 

whose television career was centered in California. The article was drawn from California 

sources, and the brunt of the harm, in terms both 

of respondent’s emotional distress and the injury 

to her professional reputation, was suffered in 

California.

Id. at 788–89. Because “California [was] the focal point 

both of the story and of the harm suffered,” it was appropriate to exercise jurisdiction over the defendants “in 

California based on the ‘effects’ of their Florida conduct in 

California.” Id. at 789.

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ACORDA THERAPEUTICS INC. v. MYLAN PHARM. INC. 15

The Supreme Court discussed the reach of Calder in 

Walden v. Fiore, 134 S. Ct. 1115, 1123–26 (2014). There, 

the Court noted:

The crux of Calder was that the reputation-based 

“effects” of the alleged libel connected the defendants to California, not just to the plaintiff. The 

strength of that connection was largely a function 

of the nature of the libel tort. However scandalous a newspaper article might be, it can lead to a 

loss of reputation only if communicated to (and 

read and understood by) third persons.

Id. at 1123–24. Walden serves to clarify Calder, but does 

not overrule it or limit its holding exclusively to libel 

cases. Rather, it makes clear that due process is not 

satisfied by a showing of “mere injury to a forum resident”; a court must examine “whether the defendant’s 

conduct connects him to the forum in a meaningful way.” 

Id. at 1125. In Calder, the defendants “‘expressly aimed’ 

‘their intentional, and allegedly tortious, actions’ at 

California because they knew the National Enquirer 

‘ha[d] its largest circulation’ in California, and that the 

article would ‘have a potentially devastating impact’ 

there.” Id. at 1124 n.7 (quoting Calder, 465 U.S. at 789–

90). The nature of ANDA litigation is such that, as in 

Calder, “the focal point both of the [filing of the ANDA] 

and of the harm suffered” is Delaware. Id. at 1123 (quoting Calder, 465 U.S. at 789) (internal quotation marks 

omitted). Jurisdiction over Mylan is proper in Delaware 

based on the “effects” of the conduct it aimed at Delaware. 

Id.

A generic drug manufacturer, like Mylan, files an Abbreviated New Drug Application (“ANDA”) with the FDA, 

seeking approval to market generic versions of drugs 

produced by brand-name drug manufacturers, like Acorda 

and AstraZeneca. See Maj. Op. at 4–5. Mylan’s filing 

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16 ACORDA THERAPEUTICS INC. v. MYLAN PHARM. INC. 

fies its belief that Acorda’s and AstraZeneca’s Orange 

Book patents are invalid or would not be infringed by 

Mylan’s proposed drug. Id. In this way, the filing of the 

paragraph IV certifications in ANDA applications at issue 

here were not random acts that happen to harm someone 

living in a particular state. As in Calder, the acts were

calculated and directed to cause harm to the intellectual 

property rights of a known party with a known location. 

It is an act which—even before a single sale of product in 

the State of Delaware—called into question the validity 

and value of property rights protecting the marketing of 

profitable products by Acorda and AstraZeneca. In so 

doing, it called into question the very value of their respective businesses. By virtue of the provisions of the 

Hatch–Waxman Act requiring that they do so, the paragraph IV certification filing also triggered an obligation to 

quickly file an expensive “infringement” action in an effort 

to lift the cloud placed on the Appellees’ business interests. See Caraco Pharm. Labs., Ltd. v. Novo Nordisk A/S, 

132 S. Ct. 1670, 1677 (2012) (“Filing a paragraph IV 

certification means provoking litigation.”).

Both Acorda and AstraZeneca are corporations organized under the laws of the State of Delaware. See Acorda Therapeutics, 78 F. Supp. 3d at 577 (“Plaintiff Acorda 

is a corporation organized under the laws of the State of 

Delaware . . . .”); AstraZeneca AB, 72 F. Supp. 3d at 552 

(“AstraZeneca’s U.S. subsidiary, AstraZeneca Pharmaceuticals LP . . . is a limited partnership operating and existing under the laws of Delaware, with its principal place of 

business in Wilmington, Delaware.”). These companies 

clearly experienced legally cognizable injuries in Delaware upon the filing of the ANDA applications by Mylan.2

 

2 The act of infringement, which the Supreme Court 

has called “highly artificial,” Eli Lilly & Co. v. Medtronic, 

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ACORDA THERAPEUTICS INC. v. MYLAN PHARM. INC. 17

Of course, “[t]he proper question is not where the 

plaintiff experienced a particular injury or effect but 

whether the defendant’s conduct connects him to the 

forum in a meaningful way.” Walden, 134 S. Ct. at 1125. 

The situs of plaintiff’s injury and the nature of it are 

factors in the analysis, but are not determinative standing alone. Id. In Calder, the Supreme Court found specific personal jurisdiction in California even though the 

allegedly libelous publication was published elsewhere

and marketed nationwide. Calder, 465 U.S. at 785 (noting that the National Enquirer “publishes a national 

weekly newspaper with a total circulation of over 5 million”). Here, there is no physical, nationally distributed

product causing harm to the plaintiffs. Despite that, the 

targeted nature of an ANDA filing—which is intended to 

challenge a particular patent owned by a known party 

with a known location—makes the case at hand just like 

that in Calder—the harm is targeted only to these Delaware companies, occurs only in Delaware, and is only 

triggered by the filing of the ANDA. While it is true, as 

the majority notes, that the filing of an ANDA application 

indicates Mylan’s desire to market its product on a nation-wide basis, including in Delaware, I find that expres-

 

Inc., 496 U.S. 661, 678 (1990), is nevertheless a defined 

and very real act of infringement that takes place wherever the ANDA filer seeks to market its product. On this 

point, I disagree with Judge Rader’s concurrence in 

Zeneca Ltd. v. Mylan Pharm., Inc., 173 F.3d 829 (Fed. Cir. 

1999), in which he found that filing an ANDA application 

merely “create[s] case or controversy jurisdiction” but 

does not, like “[m]anufacture, use, offers for sale, and 

sales,” constitute a “real act[] with actual consequences.” 

Id. at 836. I agree instead with Judge Gajarsa that the 

filing of an ANDA application “is a real act with serious 

consequences.” Id. at 834.

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18 ACORDA THERAPEUTICS INC. v. MYLAN PHARM. INC. 

sion of interest meaningful for different reasons. I believe 

it reinforces the immediate harm caused by the ANDA 

filing, regardless of whether such marketing ever occurs.

Finally, I agree with the majority and both district 

judges that the exercise of specific personal jurisdiction in 

these cases is reasonable under the Supreme Court’s 

precedent in Burger King and World-Wide Volkswagen 

Corp. v. Woodson, 444 U.S. 286 (1980). Maj. Op. at 15–16; 

Acorda, 78 F. Supp. 3d at 594–95; AstraZeneca, 72 F. 

Supp. 3d at 559–60.

For these reasons, I believe that Mylan’s activity falls 

squarely within the minimum contacts analysis described 

in Calder and clarified in Walden. Mylan’s paragraph IV 

certification in its ANDA filing connects it to Delaware—

not just to these corporate residents—in a manner that 

supports a finding of specific personal jurisdiction in that 

forum.

CONCLUSION

Thus, I would find that Mylan is subject to general 

personal jurisdiction in Delaware by virtue of its registration to do business there. To the extent this court has 

chosen to address the question of specific personal jurisdiction, moreover, I concur in the result reached by the 

majority that Mylan also is subject to specific personal 

jurisdiction in Delaware. 

Case: 15-1460 Document: 101-2 Page: 34 Filed: 03/18/2016