Court Opinion

ID: 3186866
Source: CourtListenerOpinion
Date Created: 2016-03-18 15:04:49.071313+00
Date Added: 2024-06-11T14:35:42.381740
License: Public Domain

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
                     ______________________
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-cv-
00696-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 & Tun-
nell 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, Washing-
ton, 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.
ACORDA THERAPEUTICS INC.   v. MYLAN PHARM. INC.           3

    JAMES HAROLD WALLACE, JR., Wiley Rein, LLP, Wash-
ington, 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 Pharma-
ceutical Research and Manufacturers of America. Also
represented by THOMAS SAUNDERS, THOMAS GREGORY
SPRANKLING; KEVIN SCOTT PRUSSIA, Boston, MA.

    CARTER GLASGOW PHILLIPS, Sidley Austin LLP, Wash-
ington, DC, for amici curiae Thomas C. Arthur, Richard
D. Freer, Lisa A. Dolak, Megan M. LaBelle. Also repre-
sented 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 Dis-
trict of Delaware against generic drug manufacturer
Mylan Pharmaceuticals Inc. One, assigned to Chief
Judge Stark, was brought by brand-name drug manufac-
turers Acorda Therapeutics Inc. and Alkermes Pharma
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 jurisdic-
tion—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 con-
tacts with Delaware. On interlocutory appeal, we affirm,
holding that Mylan is subject to specific personal jurisdic-
tion in these cases. We do not address the issue of gen-
eral 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.
ACORDA THERAPEUTICS INC.   v. MYLAN PHARM. INC.          5

Acorda and Alkermes then sued Mylan in the District of
Delaware for patent infringement, invoking the declara-
tion of 35 U.S.C. § 271(e)(2)(A) that the submission of a
paragraph IV certification constitutes an act of infringe-
ment. 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 pro-
posed 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 jurisdic-
tion 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 con-
nected 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 dis-
missed Mylan Inc. without prejudice.
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 ma-
terial 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 notic-
es 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 suffi-
cient 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 con-
sented 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.
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 per-
sonal jurisdiction in these cases.
     In each case the district court certified its decision for
interlocutory review, and we granted permission to ap-
peal. 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 locat-
ed,” 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 jurisdic-
tion 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 de-
fendant “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
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 suit-
related depends on “the relationship among the defend-
ant, the forum, and the litigation,” Keeton v. Hustler
Magazine, Inc., 465 U.S. 770, 775 (1984), including specif-
ically 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 Su-
preme Court has said that the minimum-contacts re-
quirement is met when the defendant “purposefully
directed” activities at the forum, “and the litigation re-
sults 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 Dela-
ware. 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
ACORDA THERAPEUTICS INC.   v. MYLAN PHARM. INC.            9

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 connec-
tion 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,” allow-
ing 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 prevent-
ing or remedying the distinctly non-artificial infringing
activities that threaten commercial harm: an order to
delay the ANDA approval that is a precondition to mar-
10           ACORDA THERAPEUTICS INC.   v. MYLAN PHARM. INC.

keting; an injunction to prevent commercial manufacture,
sale, importation, etc.; and monetary relief for such com-
mercial 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 recog-
nized 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
ACORDA THERAPEUTICS INC.   v. MYLAN PHARM. INC.           11

to patent scope or validity. Congress also added a provi-
sion 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 con-
firmed a plan to engage in real-world marketing.
     All of the parties acknowledged as much at oral ar-
gument. 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 Sup-
plement, 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 re-
quires 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 Un-
branding 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 con-
trols 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
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 com-
mercial scale.” Guidance for Industry: ANDA Submis-
sions—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 real-
world 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] non-
infringing 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 causa-
tion 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 con-
cerns 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
ACORDA THERAPEUTICS INC.   v. MYLAN PHARM. INC.          13

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 connec-
tion to the planned acts is close enough, the subject of
such actions readily fits the terms of the minimum-
contacts 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
14           ACORDA THERAPEUTICS INC.   v. MYLAN PHARM. INC.

(explaining that personal jurisdiction should realistically
consider the object of the dispute and noting that “con-
templated 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 specif-
ic 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 jurisdic-
tion 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
ACORDA THERAPEUTICS INC.   v. MYLAN PHARM. INC.          15

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 ge-
neric 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 devel-
ops drugs for the entire U.S. market and does some busi-
ness 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 “Pharmacy-
Wholesale” and a “Distributor/Manufacturer CSR.” And
even if Mylan does not sell its drugs directly into Dela-
ware, 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 estab-
lished distribution channel”).
    One point remains. A finding of minimum contacts
does not end the due-process inquiry—let alone any non-
constitutional venue inquiries—into whether a case
properly remains in a forum. Even if a defendant has
minimum suit-related contacts with a State, the defend-
16           ACORDA THERAPEUTICS INC.   v. MYLAN PHARM. INC.

ant may defeat specific personal jurisdiction by sufficient-
ly demonstrating that other considerations render juris-
diction 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 incorpo-
rated or with principal places of business in Delaware.
And upholding personal jurisdiction will serve the inter-
ests 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 consid-
erations of unfairness override the minimum-contacts
basis for Delaware’s exercise of specific personal jurisdic-
tion 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
  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
                     ______________________
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-cv-
00696-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 sepa-
rately 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, includ-
ing 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 considera-
tion of specific jurisdiction, the Supreme Court has given
some guidance about the sequencing of jurisdictional
decisions. In Steel Co. v. Citizens for a Better Environ-
ment, 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
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 (quot-
ing 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 wheth-
er, “[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 jurisdic-
tional 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 usual-
ly 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
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 resolu-
tion, 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 jurisdic-
tion over a defendant before it may act “represents a
restriction on judicial power not as a matter of sovereign-
ty, 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 jurisdic-
tion 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 per-
sonal 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
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 regis-
tered 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 require-
ment. 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, pursu-
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 jurisdic-
tion 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 conclu-
sions 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 stat-
utes—mandatory for doing business within the state—
cannot constitute consent to jurisdiction, and the Dela-
ware 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
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 juris-
diction 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 ter-
    ritory, 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 “doc-
trine 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 “incon-
venience 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 im-
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 Pennsylva-
nia 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 super-
intendent of the insurance department a power of attor-
ney 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 de-
cided Pennsylvania Fire, it has had ample opportunity to
reconsider its holding. Yet each time the issue arose, the
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 corpora-
tion 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 nar-
rower 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 Interna-
tional 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
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 corpora-
tion 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 designa-
tion of an agent for service is to make a nonresident
suable in the local courts”); Holloway v. Wright & Morris-
sey, Inc., 739 F.2d 695, 697 (1st Cir. 1984) (“It is well-
settled that a corporation that authorizes an agent to
receive service of process in compliance with the require-
ments of a state statute, consents to the exercise of per-
sonal 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 exer-
cise 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 corpora-
tion in the state as to all causes of action to which the
authority of the agent or official to accept service ex-
tends.”). 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
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 jurisdic-
tion 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 implied-
ly eradicate the distinction between cases involving an
express consent to general jurisdiction and those analyz-
ing 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 con-
sent 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 gen-
eral 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 jurisdic-
tion 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 submis-
sion 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 registra-
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 square-
ly 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 founda-
tions,” it remains the “Court’s prerogative alone to over-
rule 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 per-
sonal jurisdiction by virtue of Delaware’s consent-by-
registration 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,
ACORDA THERAPEUTICS INC.   v. MYLAN PHARM. INC.            13

                 B. SPECIFIC JURISDICTION
     A finding that Mylan has consented to general per-
sonal 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 Adjudi-
cate: A Suggested Analysis, 79 HARV. L. REV. 1121, 1136
(1966) (hereinafter von Mehren & Trautman)). “In con-
trast to general, all-purpose jurisdiction, specific jurisdic-
tion 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 reason-
ing. 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 deci-
sion 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 corpo-
rations 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.
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 jurisdic-
tion primarily on Mylan’s expressions of future intent.
     In Calder, the Court held that, when a defendant en-
gages 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 Cali-
     fornia activities of a California resident. It im-
     pugned the professionalism of an entertainer
     whose television career was centered in Califor-
     nia.   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 appro-
priate to exercise jurisdiction over the defendants “in
California based on the ‘effects’ of their Florida conduct in
California.” Id. at 789.
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 defend-
   ants to California, not just to the plaintiff. The
   strength of that connection was largely a function
   of the nature of the libel tort. However scandal-
   ous 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 resi-
dent”; 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 (quot-
ing 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 Ab-
breviated 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
under paragraph IV of 21 U.S.C. § 355(j)(2)(A)(vii) certi-
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 re-
spective businesses. By virtue of the provisions of the
Hatch–Waxman Act requiring that they do so, the para-
graph 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 inter-
ests. 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 orga-
nized under the laws of the State of Delaware. See Acor-
da 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 Pharmaceu-
ticals LP . . . is a limited partnership operating and exist-
ing under the laws of Delaware, with its principal place of
business in Wilmington, Delaware.”). These companies
clearly experienced legally cognizable injuries in Dela-
ware 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,
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 stand-
ing alone. Id. In Calder, the Supreme Court found specif-
ic personal jurisdiction in California even though the
allegedly libelous publication was published elsewhere
and marketed nationwide. Calder, 465 U.S. at 785 (not-
ing that the National Enquirer “publishes a national
weekly newspaper with a total circulation of over 5 mil-
lion”). 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 Dela-
ware 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 na-
tion-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 wher-
ever 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.
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 registra-
tion to do business there. To the extent this court has
chosen to address the question of specific personal juris-
diction, moreover, I concur in the result reached by the
majority that Mylan also is subject to specific personal
jurisdiction in Delaware.