*2 and gives holder a right of RICH, Before RADER, and GAJARSA, action against the applicant. In response Circuit Judges. to the Petition, Zeneca filed suit for infringement in the Pennsyl- Opinions filed Circuit Judges vania district court pursuant to 35 U.S.C. RADER and GAJARSA concurring in the § 271(e)(2). judgment of reversal. Circuit Judge RICH dissents opinion. without Soon after the filed, suit was dictional ping pong match we are faced GAJARSA, Circuit Judge. with began. Zeneca successfully filed a
Mylan Pharmaceuticals, Inc. (“Mylan”) motion to transfer the case to Maryland. appeals from May 13,1997 order of the Finding it lacked jurisdiction over United States District Court for the West- Mylan, the Maryland district court dis- ern (the District “Pennsyl- missed the case and transferred it back to court”) vania district granting Zeneca Lim- Pennsylvania. The Pennsylvania district (“Zeneca’s”) ited’s motion to transfer this court granted Zeneca’s motion to transfer infringement suit to the United the case back to Maryland and certified for States District Court for the District of interlocutory appeal to this court the ques- (the “Maryland court”). tion of whether the Maryland district court Judge Rader and concur in the judgment could properly exercise personal jurisdic- of reversal of the order of the Pennsylva- tion Mylan. Specifically, the question nia district court. we are asked to answer is today as follows: Mylan has only one contact with the BACKGROUND forum state Maryland:' Mylan’s act of Mylan is a corporation incorporated un- filing its tamoxifen ANDA with the FDA der the laws West Virginia with its Rockville, Maryland pursuant to 35 principal place of business in West Virgi- 271(e)(2). U.S.C. Mylan’s contact un- grounded Id. act of statutory is a statute der Amendment the First regarding concerns control- infringement.... as the federal right Fed- certified of law ling question the creation against policy well whether, Appeals Circuit eral of Co in the District supercourts national ex- light of *3 excep contacts government The lumbia. Mylan over jurisdiction personal ception, underpin process due have may tion also of the District for Court the District in by that visits (explaining See id. nings. con- by Mylan’s supported is Environmental the to nonresidents Rockville, Mary- FDA the with tacts (EPA) consti cannot Agency Protection 271(e)(2). 35 U.S.C. to pursuant land and of the the invocation tute Pharms., Inc., 968 v. Ltd. Zeneca D.C.’s of protections (W.D.Pa.1997). 268, 278-79 F.Supp. also exception). See contacts government below, I would stated Cellular Cellutech, reasons v. Centennial For the Inc. (us (D.D.C.1994) can- court 50 F.Supp. the that 871 hold Corp., ex exception over to jurisdiction contacts personal government not assert excep- government contacts with federal government the contacts light of clude Investment analysis); due process tion. States, F.Supp. 550 v. United Inst. Co. (same). (D.D.C.1982) 1213, 1216 DISCUSSION na- the exception, petitioning this Under certified the question to answer order as a “count” does not government tional to necessary interlocutory appeal, for personal in the contact jurisdictional the scope of purpose the understand Envi- example, in For analysis. con in the exception contacts government Research, of Co- District the ronmental of traditional text visits held that Appeals of Court lumbia by courts developed As analysis. personnel defendant’s nonresident by the Columbia, government the District with consult to Columbia District “entry that provides exception contacts for application concerning an officials EPA nonresi Columbia District of into aas not did count grant contacting federal for the dents plaintiffs cause contact, when even a basis is not agencies governmental governmental related action jurisdiction.” personam of in assertion Research, Environmental See contact. Intt'l, Inc. v. Research Environmental the en after years Two 813. A.2d at 355 Inc., A.2d Eng’rs, Greene Lockwood Research, in Environmental decision banc banc). (en The ratio (D.C.1976) of Columbia District panel exception for this nale excep- to narrow attempted Appeals Amend- First unique stating character in the tion its source finds concerns— process seat Columbia] not due [of District ment —and ap- basis cor- only in the principled government provides national ex- contacts access plication unfettered need for relative Silver, A.2d Rose agencies See ception. departments federal federal (D.C.1978). Many permit citizenry. To national entire Columbia, District jurisdic- sitting in the courts assert courts to [D.C] interpre- adopted the broad however, con- have whose sole nonresidents tion in En- espoused exception as dealing tation of consists the District with tact have noted Research instrumentality not vironmental a federal the en not overrule panel could Rose partic- public free a threat pose would Research. in Environmental decision would banc but also government, ipation Watt, 722 Corp. v. Consulting Naartex See of Co- District convert the threaten (D.C.Cir.1983) (explaining 779, F.2d forum. judicial a national into lumbia panel opinion Rose cannot over- right ment petition. It seems obvious rule the en banc decision Environmen- contact arose tal expressing Research and hesitancy to- out of the fortuity mere that the govern- wards adopting approach). agency the Rose ment For that must receive the Petition example, Co., in Investment in Maryland. the court ex- located It is worthy also plained: of note that the govern- ment contacts in this case would federal cases from ap- circuit deprive Zeneca aof forum in plying which to principle seek relief. It already has been respective circumstances, then* estab- how- lished that the
ever, district court spoken in traditional jurisdiction over Mylan. First Amendment terms in doing so. *4 They have simply discounted the defen- The most interesting argument against dants’ business activities in the District application of exception the is that the by the amount they in- getting involved Hatch-Waxman Act makes the submission formation from giving or information to of the an patent Petition act infringe the government, getting or govern- the ment. The Petition, submission of the permission ment’s to do something, therefore, is not merely an exercise of a which can be done Washington First Amendment right, but is also a tort. because that is government where the is. I do not believe that this argument under Furthermore, the fact that such activi- mines the exception the for ties are undertaken for “commercial” First, two reasons. I believe treating that purposes would deprive not them of such the Petition as the sole con First protection Amendment might tact subjects that personal juris to required be Silver, Rose v. for the poses diction serious constitutional issues protects First Amendment “commercial” because it Congress allows to burden un speech right and the petition as well necessarily, possibly impermissibly, a as that undertaken for less mercenary First Amendment right. See Environ reasons. Research, mental 355 A.2d at n. 11 Co., that, Investment F.Supp. (explaining if Congress 1216-17 intended to added).1 (emphasis abrogate government the contacts rule in enacting the long-arm statute, D.C. it persuaded am that the government would placed impermissible an bur exception contacts should apply in this den on the constitutional right petition). to case. Allowing jurisdiction based solely on the submission of the Petition would allow addition, refusing apply to gov- the for the creation of judicial a national forum ernment exception contacts in this case in Maryland generic for drug infringement would undermine the purpose of the cases. Not even Zeneca attempts argue to Hatch-Waxman Act. purpose of the the of the Hatch-Waxman Hatch-Waxman Act was not to transform Act towas create supercourt. such a The FDA filings into torts because peti- such fact federal agencies have had to tions are in and of themselves undesirable move to states surrounding the District of society acts that wishes to avoid. The Act Columbia is no reason the government was trying to generic dissuade drug exception contacts not to apply. In addi- manufactures from filing ANDAs and tion, it is clear was petitioning “paragraph IV” certifications. To the con- government for the right market trary, one of the purposes of the Act was generic drug. The submission of the Peti- to allow generic drug manufacturers to be tion clearly falls within the First Amend- able to FDA approval obtain market 1. Whether or not the contacts sion because the submission oí the Petition is process has due underpinnings clearly an exercise of the First Amendment change would not the outcome of right this deci- petition. unin- unnecessary and in an results on the the time drugs by
their petition punishment tended To achieve expired. drugs relevant pur- FDA, which undermines infringe- with the exempted end, Congress Act. pat- selling of of the Hatch-Waxman using pose or making, ment reasonably relat- the extent drugs to ented that, reasons, hold I would these For information ed to ais filing of although infring- Thus, traditional approval. FDA this is infringement, act statutory infringing counts as longer activity no appli- to dismiss basis sufficient not a However, holder Act. under excep- of the cation right of its benefits entitled is still tion in case. The sub- expires. until exclude paragraph ANDA of the mission begins opinion Judge Rader’s I note an act called was therefore certification TV that, general accurately stating the commercial prevent issue, Mylan cannot generic infringing an marketing of state of the courts into be haled As patent. expiration before (1) purposefully has unless previously, stated Supreme Court protec- itself availed “highly here act Maryland’s tions *5 Medtronic, Lilly Co. Eli & artificial.” Mary- of residents at its activities directed 661, 678, 110 S.Ct. Inc., 496 U.S. (2) arises land, litigation and (1990). for Writing L.Ed.2d However, agree I cannot activities. these Court, stated Scalia Justice with his conclusion be created had to infringement act of an actually with are not Mylan’s contacts pro- NDA paper and ANDA these for Rather at all. Maryland the state of is achieved That is ceedings. what gov- the federal involve Mylan’s contacts - highly a 271(e)(2) creation of § receipt of AN- office whose ernment that con- of act artificial that state. be within happens to DAs paper aor ANDA submitting an sists purpose- sense, Mylan has not same certi- type of fourth containing the NDA the benefits itself fully availed to whether as inis error fication direct- purposefully or Maryland manufacture, use, or sale commercial Maryland its activities ed course, which, (none drug new the fed- only from Mylan seeks occurred) the rele- violates actually has the FDA. through eral patent. vant activi- Therefore, directed Mylan has Id. state FDA, at the at the ties petitions of such The its residents. to resurrect FDA serves personal traditional under Unfortunately, his the benefits enjoy right to holder’s way is no analysis, there jurisdiction of action. a cause him gives avoid the fact act of in- called an was not Petition The A Maryland. in federal tort a committed generic to dissuade in order fringement in a state tort a federal that commits party a national manufacturing or create into court may be haled it notice that is on submis- Allowing the Maryland. forum Court Supreme That state. in that as the sole count the Petition sion arti- “highly as act tortious has viewed subjecting ge- a contact jurisdictional prop- is not context2 in a different ficial” juris- drug manufacturer neric information ... submitting [FDA] is- with the faced Supreme Court 2. The approval for marketing necessary to obtain 271(e)(1) ... U.S.C. "whether sue of Lilly, U.S. Eli device....” medical consti- otherwise that would activities renders was not 663-64, 2683. S.Ct. they noninfringing if tute juris- whether issue of with the developing faced undertaken are er reason for us to conclude that I also note that the question certified on filing ANDA is not a “real with “actu- act” appeal whether, asks us light al consequences.” An infringement law- government contacts exception, personal suit can be.filed federal district court in Maryland exists. because of the paragraph of a IV We being are not asked jurisdic- whether FDA, which demon- tion exists under traditional juris- strates that a filing such is a real act with diction analysis. We should at very consequences. serious least question answer the certified ap- on peal. disagree also that the exercise of comport would not with “traditional notions of play fair justice” substantial CONCLUSION because “has none of its laws to In view opinions of Judges Rader protect, enforce, interpret, or apply.” It is Gajarsa, the decision of Pennsylva- often the that a case state will have none nia district court to transfer the case back of its apply laws to when federal law issues to the Maryland district court is reversed (such infringement) are at stake. and the case is remanded pro- for further That cannot be a basis for transferring a ceedings consistent with the judgment of case. The concurrence also states that the court. Zeneca has no interest in litigating in Ma- REVERSED AND REMANDED. ryland because it is a corporation. U.K. However, appears it clear from the briefs RADER, Judge, Circuit concurring. filed that Zeneca legitimate has a interest I, litigating too, could would end this ping- consolidate cases arising pong match by from the filing reversing the order of the *6 two different respect ANDA’s with to district court transferring patent, same which may judicial result suit to the Mary- and litigant economy. Thus, court, land under tradi- but without recourse to personal tional jurisdiction analysis, so-called “government I be- excep- contacts lieve the personal exercise of tion” to jurisdiction personal jurisdiction. This court over Mylan Maryland need not permis- adopt would be exception, which the sible. courts of the District of Columbia created (and only those courts applied) have to application of the government con- finesse questions unique to exception tacts necessary therefore n Moreover, forum. of that this case because it takes into account exception in this case sidesteps the tradi- what is actually transpiring here: the ex- tional Due Process analysis mandated by ercise of the right to the federal Supreme my view, Court. In the tra- government. Such activity requires spe- ditional precludes analysis personal juris- cial consideration because the ability of the diction Mylan. Therefore, over by apply- public to participate freely government standard jurisdiction rules, I and possible conversion of states concur. where agencies federal located are into judicial national forums are serious con- jurisdiction Personal over an out-of-state cerns. These concerns are not adequately defendant involves first, two inquiries: addressed a traditional analysis per- whether the forum state’s long-arm statute jurisdiction sonal recognition therefore jurisdiction and, confers second, whether of the government contacts assertion of jurisdiction com- warranted. ports with Constitutional requirements for diction be Maryland could asserted in over a tion with the FDA.
party filing for the paragraph of a applica- IV
835
outset,
contacts are not
Mylan’s
At the
Sys.,
Implant
See Genetic
process.
due
Maryland
all.
at
the state
actually with
1455,
F.3d
123
Corp.,
v. Core-Vent
Inc.
the feder-
involve
contacts
Rather
(Fed.Cir.
1786, 1788
USPQ2d
1458, 43
receipt of
whose office
al
v. Rudz
King Corp.
1997)
Burger
(citing
that state.
to be within
happens
ANDAs
471-76,
462,
105 S.Ct.
ewicz, 471 U.S.
sense,
purpose-
Mylan has
the same
(1985)). Maryland
2174,
L.Ed.2d 528
85
of the
the benefits
itself of
fully availed
interpreted
already
courts
directed
Maryland
or
laws of
Ann.,
statute, Md.Code
long-arm
state’s
My-
Maryland residents.
at
activities
(1998),
pro
§ 6-103
Proc.
& Jud.
Cts.
from the federal
benefits
lan seeks
permit
full extent
vide
Therefore,
the FDA.
through
Talegen
See
the Constitution.
ted under
its activities at
Mylan has directed
Corp.,
Fin.
Leasing
Signet
Corp. v.
or its
FDA,
the state of
not at
(1995).
406,
663,
A.2d
410
657
Md.App.
into one.
collapse
inquiries
two
My-
though
reasoning applies even
This
123 F.3d
Sys.,
Implant
Genetic
See
constituted
ANDA itself
lan’s
v. Hockerson-H
1458;
Co.
Wing Shoe
Red
under 35
tort
1355,
Inc.,
F.3d
alberstadt,
271(e)
271(e)(2) (1994). Section
U.S.C.
(Fed.Cir.1998).
Competition
Price
Drug
part of the
1984,
Act of
Restoration
Patent Term
clause
process
the due
Under
1585,
in
98-417,
designed
99 Stat.
Pub.L.
Constitution,
distortions
compensate for
ter alia
has sufficient
if
lengthy
resulting from
term
“fair
give it
Eli
See
processes.
approval
regulatory
court
haled into
might
be
warning” that
Inc.,
Medtronic,
496 U.S.
Lilly & Co.
472,
King, 471
Burger
U.S.
See
there.
661, 669-71,
L.Ed.2d
110 S.Ct.
2174;
Volks-
474,
World-Wide
105 S.Ct.
271(e)(1)
(1990).
com
Section
Woodson, 444 U.S.
Corp. v.
wagen
freeing
patent holder
petitors
(1980).
L.Ed.2d 490
297, 100 S.Ct.
work
development
liability for
them
pur-
if it
warning
received fair
Mylan has
regulatory
securing
reasonably related
of the benefits
itself
availed
posefully
comply
testing
enabling
By
approval.
purpose-
Maryland’s
protections
*7
patent
before
processes
regulatory
at residents
activities
directed its
fully
competitors
section allows
expiration,
litigation results
forum,
if the
quickly after
more
the market
enter
See
its activities.
arising out of
injuries
limiting what would
thus
expires,
patent
471-76, 105 S.Ct.
471
at
King,
Burger
U.S.
extension of
to an
amount
otherwise
235,
Denckla, 357
2174;
v.
U.S.
Hanson
Novop
Inc.
Glaxo
See
term.
(1958).
1228, 2
253,
L.Ed.2d 1283
78 S.Ct.
1568,
1562,
42
Ltd., 110 F.3d
harm
that a
decided
defendant
it
been
“Once
(Fed.Cir.1997). Sec
1257, 1262
USPQ2d
minimum
established
hand, balances
271(e)(2), on the other
tion
State,
may
these contacts
forum
within the
271(e)(1)
by
degree
effects
of other factors
light
be considered
com
infringement
act of
making it an
per-
assertion
whether the
determine
if
an ANDA
to file
petitors
‘fair
comport with
jurisdiction would
approval
sonal
tois
obtain
” Burger
manufacture,
justice.’
substantial
play and
in the commercial
“engage
2174
476,
expira
105 S.Ct.
at
before
use,
U.S.
King, 471
or sale” of
Glaxo,
110 F.3d
v. Wash-
Shoe Co.
patent. See
International
(quoting
tion
154,
holder
320,
90
310,
point,
S.Ct.
At
ington, 326 U.S.
1568-69.
of the ANDA
approval
(1945)).
prevent
seek to
Mylan’s contacts
can
L.Ed. 95
suit.
satisfy
by bringing
these
suffice
do not
Maryland
barring
effect
have the
a suit can
Such
requirements.
Constitutional
then,
approval
ANDA
for two and a
years.
half
are insufficient
to establish
Bristol-Myers Squibb
See
Royce
Co. v.
jurisdiction.
Labs., Inc.,
1130, 1132, USPQ2d
69 F.3d
Finally, although the above suffices to
(Fed.Cir.1995).
end' the Constitutional inquiry, I note fur-
evinces,
statutory
This
framework
as'the
ther
that the
jurisdic-
exercise of
Supreme
recognized,
Court has
tion over
also would
comport
act
created
section
by
with “traditional notions of
play
fair
271(e)(2)
“highly
artificial” with a “limit-
justice.”
substantial
Mylan’s filing
pa-
ed and
purpose.”
technical
Lilly
Eli
& pers with a
agency
federal
happens
Co.,
678,
U.S.
real acts with actual consequences. Such compelling interest. Zeneca is incorporat- acts fall within our traditional understand- ed under the laws England with its infringement, see 35 U.S.C. place principal of business in England. It § 271(a), and subject a defendant to full has identified no additional burden it liability under law. Commercial manu- would encounter litigating in Pennsyl- facture, use, sale, offers and sales are vania, where parent place has a legal fictions, but rather genuine are business, rather than Maryland. that, economic acts unlike the filing of an ANDA, sum, operate under the because Mylan’s commercial laws contacts with of a forum state or are target deficient, Constitutionally markets and if Mylan cannot exercise such engaged haye acts in Maryland, might Mylan. diction over reasonably agree therefore foreseen the this- court possibility of being should haled into reverse transfer or- der courts against to defend con- court and *8 sequences of those acts. remand. Because this court can reach that conclusion under a traditional due The “highly artificial” act of filing an process analysis, I believe it need not ANDA neither advantage takes' Mary- adopt the “government exception” land’s legal commercial laws and struc- as the law of this circuit. tures targets nor Maryland’s markets and Indeed, the mere filing of an ANDA does not point even cause a
tangible injury holder. Ac-
cordingly, I Mylan’s believe that filing of
an ANDA did fairly warn possi-
bility implicit submission Maryland
courts. contacts with Maryland,