ACORDA THERAPEUTICS INC., ALKERMES PHARMA IRELAND LIMITED, Plaintiffs-Appellees
MYLAN PHARMACEUTICALS INC., MYLAN INC., Defendants-Appellants; ASTRAZENECA AB, Plaintiff-Appellee
MYLAN PHARMACEUTICALS INC., Defendant-Appellant
from the United States District Court for the District of
Delaware in No. 1:14-cv-00935-LPS, Chief Judge Leonard P.
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.
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.
NOREIKA, Morris, Nichols, Arsht & Tunnell LLP, Wilmington,
DE, for plaintiff-appellee Alkermes Pharma Ireland Limited.
Also represented by JACK B. BLUMENFELD, JEREMY A. TIGAN.
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.
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.
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.
HAROLD WALLACE, JR., Wiley Rein, LLP, Washington, DC, for
amicus curiae Generic Pharmaceutical Association. Also
represented by A. CLAIRE FREZZA, MARK PACELLA, ERIC HAROLD
M. JAY, Goodwin Procter LLP, Washington, DC, for amicus
curiae Teva Pharmaceuticals USA, Inc. Also represented by
BRIAN TIMOTHY BURGESS.
J. GLANCY, White & Case LLP, New York, NY, for amicus curiae
Biotechnology Industry Organization. Also represented by ADAM
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,
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.
NEWMAN, O'MALLEY, and TARANTO, Circuit Judges. OPINION
filed by Circuit Judge TARANTO. Opinion concurring in the
judgment filed by Circuit Judge O'MALLEY.
Taranto, Circuit Judge.
appeals involve two actions brought in the District of
Delaware against generic drug manufacturer Mylan
Pharmaceuticals Inc. One, assigned to Chief Judge Stark, was
brought by brand-name drug manufacturers Acorda Therapeutics
Inc. and Alkermes Pharma Ireland Ltd.; the other, assigned to
Judge Sleet, was brought by brand-name drug manufacturer
AstraZeneca AB. The plaintiffs brought the actions under 35
U.S.C. § 271(e)(2), alleging that their patents cover
drugs that Mylan has sought permission from the Food and Drug
Administration to manufacture and market. Mylan moved to
dismiss on the ground that Delaware could not (and so the
federal court may not) exercise personal jurisdiction--either
general or specific personal jurisdiction--over Mylan in
these cases. Chief Judge Stark and Judge Sleet denied the
motions. Although they reached different conclusions about
whether Delaware could exercise general personal jurisdiction
over Mylan based on consent given in registering to do
business in the State, they both concluded that Delaware
could exercise specific personal jurisdiction, based on
Mylan's suit-related contacts with Delaware. On
interlocutory appeal, we affirm, holding that Mylan is
subject to specific personal jurisdiction in these cases. We
do not address the issue of general personal jurisdiction.
the authority of the FDA's approval of its New Drug
Application (NDA), 21 U.S.C. § 355(a), (c), Acorda
markets Ampyra® to help individuals with multiple
sclerosis walk. In seeking approval for Ampyra®, Acorda
identified five patents for listing in the FDA's
Approved Drug Products with Therapeutic Equivalence
Evaluations publication--the " Orange Book."
See 21 U.S.C. § 355(b)(1); 21 C.F.R. §
§ 314.3, 314.53. Acorda owns four of the patents and is
the exclusive licensee of the fifth, owned by Alkermes. In
January 2014, Mylan filed an Abbreviated New Drug Application
(ANDA) with the FDA under 21 U.S.C. § 355(j), seeking
approval to market generic versions of Ampyra® . Under
paragraph IV of § 355(j)(2)(A)(vii), Mylan certified
that Acorda's Orange Book patents for Ampyra® are
invalid or would not be infringed by Mylan's marketing of
its proposed drug. Acorda and Alkermes then sued Mylan in the
District of Delaware for patent infringement, invoking the
declaration of 35 U.S.C. § 271(e)(2)(A) that the
submission of a paragraph IV certification constitutes an act
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.
filed motions to dismiss under Federal Rule of Civil
Procedure 12(b)(2) on the ground that the State of Delaware
could not--and therefore, derivatively, the federal district
court in Delaware may not--exercise personal jurisdiction
over Mylan in these matters under the Due Process Clause of
the Fourteenth Amendment. The parties do not dispute that the
standards of the Due Process Clause control whether there is
personal jurisdiction in these matters. Nor do they dispute
that the Due Process Clause standards permit a State to
exercise either specific personal jurisdiction over a
defendant in a case (based on the connection of the State to
the subject matter of the particular case) or general
personal jurisdiction over the defendant (based on certain
facts even where the case involves subject matter not itself
sufficiently connected to the State). The parties have
debated both specific and general personal jurisdiction in
this case. The debate over the latter issue focuses on
Mylan's registration to do business in Delaware as giving
consent to the exercise of general personal jurisdiction.
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.
Judge Stark (in the Acorda case) and Judge Sleet (in
the AstraZeneca case) denied the motions to dismiss.
Both judges concluded that Delaware had sufficient contacts
related to the subject of these cases that it could exercise
specific personal jurisdiction over Mylan. See
Acorda Therapeutics, Inc. v. Mylan Pharms. Inc., 78
F.Supp.3d 572, 593-95 (D. Del. 2015); Astrazeneca AB v.
Mylan Pharms., Inc., 72 F.Supp.3d 549, 558-60 (D. Del.
2014). The two judges disagreed about whether Delaware could
exercise general personal jurisdiction (independent of
suit-related contacts) on the ground that Mylan consented to
such jurisdiction in registering to do business: they took
different views of the status of Supreme Court decisions
supporting such jurisdiction, e.g., Pa. Fire
Ins. Co. v. Gold Issue Mining & Milling Co., 243 U.S.
93, 37 S.Ct. 344, 61 L.Ed. 610 (1917), in light of later
decisions such as Daimler AG v. Bauman, 134 S.Ct.
746, 187 L.Ed.2d 624 (2014). See Acorda, 78
F.Supp.3d at 587-90; AstraZeneca, 72 F.Supp.3d at
556-57. But the latter disagreement
did not alter the finding of personal jurisdiction in these
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).
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).
court may exercise specific personal jurisdiction without
violating the Due Process Clause when the defendant "
ha[s] certain minimum contacts with [the forum] such that the
maintenance of the suit does not offend 'traditional
notions of fair play and substantial justice.'"
Int'l Shoe Co. v. Washington, 326 U.S. 310, 316,
66 S.Ct. 154, 90 L.Ed. 95 (1945). The minimum-contacts
requirement focuses on whether " the defendant's
suit-related conduct . . . create[s] a substantial connection
with the forum State." Walden v. Fiore, 134
S.Ct. 1115, 1121, 188 L.Ed.2d 12');">188 L.Ed.2d 12 (2014). What conduct is
suit-related depends on " the relationship among the
defendant, the forum, and the litigation," Keeton v.
Hustler Magazine, Inc., 465 U.S. 770, 775, 104 S.Ct.
1473, 79 L.Ed.2d 790 (1984), including specifically the
nature of the claim asserted. See Calder v.
Jones, 465 U.S. 783, 789-90, 104 S.Ct. 1482, 79 L.Ed.2d
804 (1984); Walden, 134 S.Ct. at 1124 (" The
strength of [the defendant's] connection [to California
in Calder] was largely a function of the nature of
the libel tort." ). In a formulation worded to address
suits for retrospective relief based on past acts, the
Supreme Court has said that the minimum-contacts requirement
is met when the defendant " purposefully directed"
activities at the forum, " and the litigation results
from alleged injuries that 'arise out of or relate
to' those activities." Burger King Corp. v.
Rudzewicz, 471 U.S. 462, 472-73, 105 S.Ct. 2174, 85
L.Ed.2d 528 (1985) (citations omitted); see
Grober v. Mako Prods., Inc., 686 F.3d 1335, 1346
(Fed. Cir. 2012). Here, Mylan has taken the costly,
significant step of applying to the FDA for approval to
engage in future activities--including the marketing of its
generic drugs--that will be purposefully directed at Delaware
(and, it is undisputed, elsewhere). If Mylan had already
begun its deliberate marketing of these drugs in Delaware,
there is no doubt that it could be sued for infringement in
Delaware. Its Delaware sales would be acts committed in the
State that are wrongful--if the plaintiffs here are right
about infringement and validity--and would concretely injure
Acorda and AstraZeneca in the State by displacing some of
their Delaware sales and likely lowering the price they could
charge there. See World-Wide Volkswagen Corp. v.
Woodson, 444 U.S. 286, 297, 100 S.Ct. 559, 62 L.Ed.2d
490 (1980); Beverly Hills Fan Co. v. Royal
21 F.3d 1558, 1565-66 (Fed. Cir. 1994). In our view, the
minimum-contacts standard is satisfied by the particular
actions Mylan has already taken--its ANDA filings--for the
purpose of engaging in that injury-causing and allegedly
wrongful marketing conduct in Delaware.
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).
Hatch--Waxman Act recognizes the close connection between an
ANDA filing and the real-world acts that approval of the ANDA
will allow and that will harm patent-owning brand-name
manufacturers. In 35 U.S.C. § 271(e)(2), Congress
declared the ANDA filing to be what has been called an "
artificial act of infringement," allowing the brand-name
manufacturer to sue the ANDA filer to litigate patent
validity and coverage. Eli Lilly & Co. v. Medtronic,
Inc., 496 U.S. 661, 678, 110 S.Ct. 2683, 110 L.Ed.2d 605
(1990). In so doing, Congress stressed the ANDA filer's
" purpose . . . to obtain approval under such Act to
engage in the commercial manufacture, use, or sale of a drug
. . . claimed in a patent or the use of which is claimed in a
patent before the expiration of such patent," 35 U.S.C.
§ 271(e)(2)(A)--concrete, non-artificial acts of
infringement. The relief available in such a suit, moreover,
is focused on preventing or remedying the distinctly
non-artificial infringing activities that threaten commercial
harm: an order to delay the ANDA approval that is a
precondition to marketing; an injunction to prevent
commercial manufacture, sale, importation, etc.; and monetary
relief for such commercial activities in the past.
Id. § 271(e)(4).
an ANDA filer's paragraph IV certification regarding
patents addresses the real-world actions for which approval
is sought--specifically, whether those actions would
infringe. 21 U.S.C. § 355(j)(2)(A)(vii)(IV)
(certification states that patent will not be infringed
" by the manufacture, use, or sale of the new drug for
which the application is submitted" ); 21 C.F.R. §
314.94(a)(12)(i)(A)(4) (same). This court has long recognized
that the infringement inquiry called for by § 271(e)(2)
is " whether, if a particular drug were put on
the market, it would infringe the relevant
patent" in the usual, non-artificial sense.
Bristol-Myers Squibb Co. v. Royce Labs., Inc., 69
F.3d 1130, 1135 (Fed. Cir. 1995); seeSunovion
Pharms., Inc. v. Teva Pharms. USA, Inc., 731 F.3d 1271,
1278-79 (Fed. Cir. 2013) (question is whether the conduct for
which filer seeks approval would infringe); see alsoEli Lilly & Co., 496 U.S. at 678 (§
271(e)(2)'s " act of infringement . . . consists ...