*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. 110 S.Ct. 2683. In in Maryland reside not qualify does 271(e)(2) section employs legal sumi significant contacts with that state at all. fiction of a defined act of infringement to This situation is one in plain- which “the create case or controversy jurisdiction, tiffs interest and the state’s interest thereby enabling a promptly court to re- adjudicating dispute in the forum are any solve dispute concerning infringement so they attenuated that clearly are out- validity subject patent. See weighed by the burden of subjecting the Glaxo, 110 F.3d at 1569. Section defendant to litigation within the forum.” 271(e)(4)(C)recognizes the artificial nature Beverly Hills Fan Royal Co. v. Sovereign filing of an ANDA limiting mone- Corp., 21 F.3d USPQ2d tary relief to unauthorized commercial 1001, 1009 (Fed.Cir.1994)., Maryland has manufacture, use, sale, offer for or sale of no interest hearing case. It has the patented invention. none of its protect, enforce, laws to inter- Manufacture, use, sale, offers for and pret, apply. laws at issue are sales, ANDA, unlike the of an are federal laws. Nor does Zeneca any

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,