## United States Court of Appeals for the Federal Circuit

04-1186 TEVA PHARMACEUTICALS USA, INC., Plaintiff-Appellant,

v. PFIZER INC., Defendant-Appellee. Henry C. Dinger , Goodwin Procter LLP, of Bo ston, Massachusetts, filed a combined petition for panel rehearing and r ehearing en banc for plaintiff-appellant. Of counsel on the petition was Thomas J. Meloro, Jr. , Kenyon & Kenyon, of New York, New York. Dimitrios T. Drivas , White & Case LLP, of New York, New York, filed an opposition to the petition fo r defendant-appellee. With him on the opposition were Jeffrey J. Oelke and Adam Gahtan

. Brian T. Moriarty , filed an amicus curiae brief fo r the Generic Pharmaceutical Association. William L. Mentlik , Lerner, David, Littenberg, Krumholz & Mentlik, LLP, of Westfield, New Jersey, filed an amicus curiae brief for IVAX Pharmaceuticals, Inc. With him on the brief was Roy H. Wepner

. Lawrence DeMille-Wagman , Attorney, Federal Trade Commission, of Washington, DC, filed an amicus curiae brie f for the Federal Trade Commission. With him on the brief were John D. Graubert , Acting General Counsel; Susan A. Creighton , Director, Bureau of Competition; John F. Daly , Deputy General Counsel for Litigation; and Lore A. Unt , Counsel for Intellectual Property. Theodore Case Whitehouse , Willkie Farr & Gallagher LLP, of Washington, DC, filed an amici curiae brie f for United States Senators Edward M. Kennedy, John S. McCain, and Charles E. Schumer. Appealed from: United States District C ourt for the District of Massachusetts Judge Richard G. Stearns

## United States Court of Appeals for the Federal Circuit

04-1186 TEVA PHARMACEUTICALS USA, INC., Plaintiff-Appellant,

v. PFIZER INC., Defendant-Appellee. ON PETITION FOR PANEL REHEARING AND REHEARING EN BANC Before MICHEL, Chief Judge , NEWMAN, MAYER, LOURIE, CLEVENGER, RADER, SCHALL, BRYSON, GAJARSA, LINN, DYK, and PROST, Circuit Judges

. O R D E R A combined petition for panel rehearing an d rehearing en banc was filed by the Appellant, and a response thereto was invit ed by the court and filed by the Appellee. 1 The petition for rehearing was referred first to the merits panel that heard the appeal. Thereafter, the petition for rehearing en banc, response, and the amici curiae briefs were referred to the circuit judges who are authorized to request a poll whether to rehear the appeal en banc. A poll was requested, taken, and failed. Upon consideration thereof, IT IS ORDERED THAT: (1) The petition for panel rehearing is denied.

1 Amicus curiae briefs were filed by: 1- The Federal Trade Commission. 2- The Generic Pharma ceutical Association. 3- Ivax Pharmaceuticals, Inc. 4- United States Senators Edward M. Kennedy, John S. McCain, and Charles E. Schumer.(2) The petition for re hearing en banc is denied. (3) The mandate of the cour t will issue on April 11, 20 05. MAYER, GAJARSA, and DYK, Circuit Judges , would rehear the appeal en banc. GAJARSA, Circuit Judge , with whom DY K, Circuit Judge , joins, dissents in a separate opinion. DYK, Circ u it Judge , with whom GAJARS A, Circuit Judge , joins, dissents in a separate opinion.

F O R T H E C O U R T

_ April 4, 2005

_ _

_ s/ Jan Horbaly

_ Date Jan Horbaly C l e r k

cc: Henry C. Dinger, Esq. Dimitrios T. Drivas, Esq. William L. Mentlik, Esq. Sarah Lenz Lock, Esq. Lawrence DeMille-Wagman, Esq. Brian T. Moriarty, Esq. Theodore Case Whitehouse, Es q.

04-1186 2

## United States Court of Appeals for the Federal Circuit

04-1186

TEVA PHARMACEUTICALS USA, INC., Plaintiff-Appellant,

v. PFIZER, INC., Defendant-Appellee.

GAJARSA, Circuit Judge , with whom DYK, Circuit Judge , joins, dissenting from the order declining rehearing en banc

. The Court has denied the petition to review this case en banc . I must respectfully dissent from that denial. This is a critical issue under the Hatch-Waxman Act. 1 The failure of this court by en banc action to correct the Teva court’s decision, 395 F.3d 1324 (Fed. Cir. 2005), allows the statutory procedures to be manipulated by the patent holders to the clear and foreseeable de triment of the generic drug industry. The Teva court’s reasonable appr ehension analysis is the wrong test for a concrete, actual, or imminent injury in fact when considering the problem of a generic

1 The Patent Laws and Drug Pric e Competition and Patent Term Restoration Act of 1984, Pub. L. No. 98- 417, 98 Stat. 1585 (codified at 21 U.S.C. §§ 355, 360(cc) (2000), 35 U.S. C. §§ 156, 271 and 282 (2000)), as amended by Title XI of the Medicare Prescription Drug, Impr ovement, and Modernization Act of 2003, Pub. L. No. 108-173, 117 Stat. 2066 (codified as am ended at 21 U.S.C.A. § 355(j)(5)(C)(i) (West Supp. 2004) and 35 U.S.C.A. § 271(e)(5) (West Supp. 2004)).with a s e cond-filed AN DA certific ation. 2 Article III does not compel it, and the Supreme Court has rejected the doctrinal rigidity that Teva introduces. Our cases recognize reasonable apprehension, in the typical patent infringement ca se, as but a pragmatic attempt to give oper ational guidance agai nst which patentees can struc t ure their conduct, and control their litigation costs, in a fact-specific ar ea of law. The ANDA facts correspond to the typical infringement case in nam e only, and it is this court’s constitutional duty to look at thos e facts in their proper context. The Tev a court’s misguided Article III analysis further thwarts Congress’s clear intent to foster, through the detailed provisions of Hatch-Waxm an, greater competition in generic pharmaceuticals.
I. The question is whet her Teva has shown a justiciable case or controversy within Article III. Congress unambiguousl y swept aside any additional limitation on jurisdiction potentially introduced by the Declaratory Judgment Act, 28 U. S.C. § 2201. [T]he courts of the United States sha ll, to the extent consistent with the Constitution, have subject matter jurisdic tion in any action brought by such person under section 2201 of title 28 fo r a declaratory judgment that such patent is invalid or not infringed. 35 U.S.C.A. § 271(e)(5) (Wes t Supp. 2004), as added by Pu b. L. 108-173, 117 Stat. 2457 (Dec. 8, 2003). The law is clear that this justiciabili ty issue has three elements: (1) a concrete, actual or imminent injury in fact; (2) fairly traceable causation between the injury and defendant’s conduc t; and (3) redressabilit y. See Steel Co. v. Citizens for a Better Env’t , 523 U.S. 83, 103-04 (1998); Valley For ge Christia n Coll. v. Ams. United

2 The overall scheme of the Hatch-Waxm an A c t is described in deta il in ou r decisions in Mylan Pharms., Inc. v. Thompson , 268 F.3d 1323 (Fed. Cir. 2001) and Andrx Pharms., Inc. v. Biovail Cor p

. , 276 F.3d 1368 (Fed. Cir. 2002).
04-1186 - 2 -for Separation of Chur ch and State, Inc. , 454 U.S. 464, 472 (1982). Only the concrete injury in fact is disputed. The cases treat the controversy require ments of Article III and § 2201 together and their approach is instructive here. Ju risdiction under § 2201 can be no broader than jurisdiction under Article III, yet the cases show that § 2201 is very broad indeed. Article III is no narrower. Se e Aetna Lif e Ins. Co. of Hartford, Conn. v

. Haworth , 300 U.S. 227, 240 (1937) (§ 22 01 “has regard to the consti tutional provis ion and is operative only in respect to controversies whic h are such in the constitutional sense[.]”). As the Supreme Court recogni z e s, the § 2201 controversy r equirement is highly fac t specific. The difference between an abstr act question and a ‘controversy’ contemplated by the Dec l aratory J udgment Act is necessarily one of degree, and it would be difficult, if it wou l d be poss i ble, to fas h ion a precise test for determining in ever y case whether there is such a controversy. Basically, the question in each case is whether the facts alleged, under all the circumstances, show that there is a substantial controversy, between parties having adv er se legal int e rests, of sufficient immediacy and reality to warrant the issuanc e of a declaratory judgment. Md. Cas. Co. v. Pac. Coa l & Oil Co. , 312 U.S. 270, 273 (1941)

. The Supreme Court, 3 this court, 4 and our sister circuits 5 consistently apply t h is holding by look ing to all the circumstances surrounding a controversy.

3 See Steel Co. , 523 U.S. at 103-04; Duke Power Co . v. Carolina Envtl. Study Group, Inc. , 438 U.S. 59, 81 (1978) (finding ac t ual case and controversy where plaintiffs would sustain injury from operati on of planned nuclear power plant, and injury was redressable by constitutionality challenge to Price-Anderson Act). 4 See EMC Corp. v. Norand Cor p

. , 89 F.3d 807, 810 (Fed. Cir. 1996) (quoting Md. Cas. ); BP Chems. Ltd. v. Union Carbide Corp. , 4 F.3d 975, 978 (Fed. Cir. 1993) (“There is no simple rule that addre sses all shades of relationships between disputants.”); Arrowhead Indus. Water, Inc. v. Ecoloc hem, Inc. , 846 F.2d 731, 735-36 (Fed. Cir. 1988) (observing “there is no s pecific, all-purpos e test” for an actual controversy).
04-1186 - 3 -A. The Tev a majority opinio n do es not, and its reasons f o r failin g to do so are not convinc i ng. In far more difficult factual cont exts the courts have nonetheles s found “a concrete, actual or imminent injury in fact” satisfyi ng Article III. In Duke P o wer Co. v. Carolina Envtl. Study Group, Inc. , 438 U.S. 59 (1978), for example, the appellee s challenged the constitutionality of the Price- Anderson Act. By that Act, Congress limited the aggregate tort liability of nuclear power plant oper ators for a single nuclear “incident.” The app ellant was a utility that was constructing nuc lear power plants. The appellees, including persons “who li ve within clos e pr oximity of t he planned facilities,” challenged the st atute under the Fi fth Amendment. Id. at 67 (emphasis added). Their theory was that “ in the event of a nuclear accident their property would be ‘ t aken’ without any assurance of just compensation.” Id. at 69 (emphasis added). The court concluded that this th eory stated a ju sticiable Article III contr o versy. See id. at 81 (“[A]ppellee s will sust ain immediate injury fr om the operation of the disputed power plants.”). The breadth of Article III standing in environmental case s sharply contrasts wit h the Teva c ourt’s narrow construction in this ANDA c ontext. The Supreme Court has held that a concrete injury in fact, for Arti cle III, is shown where a non-profit’s members allege that a polluter’s discharge s, “and the affiant members’ reasonable concerns about the effects of those disc harges, directly affe cted those affiants’ recreational, aesthetic, and economic interests.” Friends of the Earth, Inc. v. Laidlaw Envtl. Servs.

5 See , e.g. , Riva v. Mass. , 61 F.3d 1003, 1009-10 (1st Cir. 1995); Kidder, Peabody & Co., Inc. v. Maxus Energy Corp. , 925 F.2d 556, 562- 63 (2d. Cir. 1991); Oneida Tribe of Indians of Wis. v. State o f Wis. , 951 F.2d 757, 760 (7th Cir. 1991).
04-1186 - 4 -(TOC), Inc. , 528 U.S. 167, 183-84 (2000) (emphasis added). The Court expressly ruled that conditional statements – th at members would us e a riv e r for recreation if Laidlaw stopped discharging pollutants into it – sufficed to show concrete injury in fact under Article III. Id. at 184. Teva’s injur y in this case, by comparison, is far more immediate. The facts showing Teva’s “concrete, actual or imminent injury” are far easier to identify. Ivax filed t he first ANDA on t he active ingredient f o r Zoloft; Teva filed a subsequent or second ANDA. Teva certif ied that its proposed formulation would not infringe Pfizer’s U.S. Patent No. 5,248,699, or t hat the patent was in valid. Pfizer had 45 days to sue Teva for this patent infringemen t, 35 U.S.C. § 271(e)(2)(A), and did not. Although Pfizer had s ued Ivax, t hey settled out of court. Pfizer granted Ivax a royalty bearing lic ense for the ’699 pat ent, preserved Ivax’s 180 day statutor y exclusiv ity, and designed a comfortable duopoly set to begin on June 30, 2006 and pot entially last 180 days past the ’699 patent expir a tion in 2010. The FDA therefore could not approve Teva’s generic drug until 180 days after Ivax’s exc l usiv ity expired – when eit her the ’699 patent expired or was invali dated – and without FDA approval Tev a could not market its product. By settling with Ivax, Pfizer lever aged t he Hatch-Waxman exclus iv ity to insulate the ’699 patent from any validity challenge. Pfizer also in sulated itself from any judicia l determination of the metes and bounds of its ’ 699 patent claim scope in relation to a design-around, a determination central to t he proper function of our patent system. Because of this insular effect, Pfi z er effect ively extended – as against all but Ivax – the

04-1186 - 5 -term of its underlying U.S. Pa tent No. 4,356,518, which expires on June 30, 2006, to coincide with the ’699 patent’s later expiration in 2010. 6 This ties up Teva’s investment in it s proposed generic until at least 2010 , precludes it from testing a potentially we ak patent, precludes it from triggering the statutory exclusiv ity period with a successful validity ch allenge, and precludes it from introducing an effective design-around, as is its right and as the pat ent law encourages

. The live controversy i s found on the face of this bottleneck under the statute. 7 Any of this defines a concrete, actual or imminent in jury in fact within the meaning of Article III, and on that basis Teva states a ju sticiable controversy under § 2201.
B. None of these problems can be found in th e typical patent infringement context, in whic h this court has regularly tested i mmediate injury in fact by the reasonable apprehens ion test. Consistent with Maryland Casualty , this court has never held that Article III required that analysis. Quite to the contrary, this court has repeatedly observed t hat reasonable apprehension was si mply a functional approach to typical patent infringement probl ems under § 2201. See EM C Corp. v. Norand Corp. , 89 F.3d

6 That is, the ’518 patent claims the active ingredi ent in Zoloft. The ’699 patent is an improvement. A generic, like Te va, that could des i gn around the ’699 but not the ’518 – or that thought it had found invalidating art for the ’699 pate nt – would need a license to the ’518 patent to enter t he market, or face an infringeme n t action. Once the ’518 patent expired, Teva could c o nfidently ente r the market with a compound that did not infringe the ’ 699 patent. But because of t he Hatch-Waxman exc l usiv ity, Pfizer insulated the ’699 patent f r om any test in litigation. In practice this extends the ’518 patent term until the ’699 pat ent expires

. 7 Cf. Mova Pharm. Corp. v. Shalala , 140 F. 3d 1060, 1073 n.18 ( D .C. Cir. 1998) (“It is possible that such a statut orily-created bottlenec k, coupled with the statute’s express reference to declaratory ju dgment actions as a means of reliev i ng that bottleneck, might suffice to allow a plainti ff to show the existence of a ‘case or controversy’ without demonstrating an immediate risk of being sued.”).
04-1186 - 6 -807, 810 (Fed. Cir . 1996) (quoting Md. Cas. ); BP Chems. Ltd. v. Union Ca rbide Corp. , 4 F.3d 975, 978 (Fed. Cir. 1993) (“There is no simp le r u le that addresses all shades of relationships between disputants.”); Arrowhead Indus. Water, In c. v. Ecolochem, Inc. , 846 F.2d 731, 735-36 (Fed. Cir. 1988) (observing “there is no specific, all-purpose test” for an actual controversy). The purpose of the reasonable apprehens io n analysis “is to determine whether the need for judicial attention is real and immediate.” BP Chems. , 4 F.3d at 978. The Teva court ignores this precedent and reads general infringemen t policy cons iderations into Article III, where they do not belong. The contextual differences between the sec ond ANDA filer and the typical patent infringement case make the reas onable apprehensio n test inappropriate for this action. By guiding the patentee’s cond uct in the typical cas e , the reasonable apprehension analys is allows the patentee to avoid litigation. Identif ying a justiciable cont roversy in terms of a threat of infringem ent litigation, the doctrine est ablishes the circumstances in which the uncertainty of legal rights mate rially harm a potential infringer in th e marketplace. The injury facing Teva in t h is case is different in kind, but no less actionable. Teva’s injury does not depend on threats from the incumbent. In view of the statute, the injury exists independent of any threat, and the policy motivation for apply i ng the reasonable apprehension test is comp letely lacking. There is no sense in the court demanding the incumb ent to brandish the threat of infringement actions, even beyond the act of listing a patent in the Or ange Book , given a statutory system that encourages the inc u mbent to do everything pos s i ble to prevent its patents from being put in play. No incumbent will ev er make the threat, if it can simply ride out the term in

04-1186 - 7 -the listed patent. 8 From first principles, a fact specific analysis shows that the reasonable apprehens ion test is not designed for this case.
II. The language of § 271(e)(5) gra n ts Articl e III ju risdiction to the maximum extent possible. The statute provi des that the courts shall have subject matter jurisdiction. The majority’s analys is in Tev a of the legislativ e hi story to the 2003 Act 9 seems addressed to this point, but its reasoning is unconvinc i ng. The statute specifically prov ides that the courts “shall, to the extent consistent with the Constitution, have subject matter jurisdiction in any action.” The court, therefore, has a Congressiona l directive to refrain from applying any jurisdictional limitation crafted by the cour ts or found in § 2201. The Teva court overlooks this basic point. The Teva court further focuses on the langua ge originally introduced for § 271(e)(5), which provided that an incumbent ’s failure to sue within 45 days “shall establish an actual controversy betw een the applic ant and the patent owner.” Teva , 395 F.3d at 1336. In conf erence the language was changed to a provision that the courts “shall, to the extent consistent with the Constitution, have subj ect matter jurisdiction” over these actions. Id. The court concludes that § 271(e)(5) was “not meant to automatically bestow district court ju risdiction over actions such as Teva’s.” Id. This conclus i on is contrary to the pl ain language of § 271(e)(5). The change in

8 See Minn. Mining and Mfg. Co. v. Barr Labs., Inc. , 289 F.3d 775 (Fed. Cir. 2002). 9 Title XI of the Medicare Prescripti on Drug, Improvement, and Modernization Act of 2003, Pub. L. No. 108-173, 117 Stat. 2066 (codified at 21 U.S.C.A. § 355(j)(5)(C)(i) (West Supp. 2004) and 35 U.S. C.A. § 271(e)(5) (West Supp. 2004)) [hereinafter “2003 Act”].
04-1186 - 8 -language bestowed full Article III jurisdiction and simply recognizes the court’s role in declaring when the judicial powers under Article III ex tend to this action. It does not bear on the proper scope of Article III. The Tev a c ourt also focuses on a Committee Report accompanying the modified 2003 Act. The language in the Report c annot contradict the plain languag e o f § 271(e)(5). A legis l ative enac tment cannot limit the judicial power under Article III, and , a fortiori , language in a Committee Report that mi sstates our Article III jurisprudence cannot bind this court. Ultimately, the idea t hat § 271(e)(5) suggests a limitation on standing is misplaced, given the plain language of Ha tch-Waxman. The statute provides an
express mechanism f o r generics to challenge, with declaratory acti ons, the claim scope or validity of listed patents. Under this s t atutory scheme, it is court challenges by generic drug companies that lim it incumbent overreaching by submitting over-inclusive lists of patents applic able to any given branded formulation. Congress’s intent to foster early generic market entry precludes any r eal argument for any lim itation. Certainly under the circumstances of this case, Teva’s declarat o ry action is the ideal method to polic e Pfiz er’s strategic mani pulation of the Hatch-Waxm an exc l usiv ity provisions. Delay ed resolution of the bottleneck facing Teva ser v es no pur pose, as by then the patents at issue will have ex pi red. There is no basis for pr ecluding this suit on Article III grounds.
III. The Teva court’s Article III a nalysis dist orts longstanding Supreme Court jurisprudence and misapplies the decisions of this court. Teva has presented a

04-1186 - 9 -justiciable controversy, and the courts should decide it. Worst of all, the Teva court’s Article III analysis forestalls l egislative correction. The c ourt should have corrected this

error en banc . I respe c tfully dissent from th e refusal to do so.

04-1186 - 10 -

## United States Court of Appeals for the Federal Circuit

04-1186 TEVA PHARMACEUTICALS USA, INC., Plaintiff-Appellant,

v.

PFIZER, INC., Defendant-Appellee.

DYK, Circuit Judge , with whom GAJARSA, Circuit Judge , joins, dissenting from the order denying rehearing en banc

. This case presents an important question under the Hatch-Waxman Amendments, which were enact ed as part of the Drug Pric e Competition and Patent Term Restoration Act of 1984, Pub. L. No. 98-417, 98 Stat. 1585 (codified at 21 U.S.C. §§ 355, 360cc (2000) and 35 U.S.C. §§ 156, 271, 282 (2000))—whether a patent holder can delay Food and Drug Administration (“F DA”) approval of an application for a competing generic drug by the simple expedient of refusing to sue for infringement. Here there is a present controversy over Teva’s right to secure approval of its Abbreviated New Drug Application (“ANDA ”), plainly adequate to satisfy the requirements of Article III. The Declaratory Judgment Act, 28 U. S.C. § 2201 (2000), and the 2003 Medicare Amendments, Medicare Prescription Drug, Improvement, and Modernization Act of 2003, Title XI, Access to Affo rdable Pharmaceuticals, P ub. L. No. 108-173, 117 Stat.2066, 2448-69 (codified in pertinent part at 21 U.S.C.A. § 355(j)(5)(C)(i) (West Supp. 2004) and 35 U.S.C.A. § 271(e )(5) (West Supp. 2004)), were designed to create a declaratory judgment remedy in circumstanc es permitted by Article III. The panel’s holding, relying on earlier decisions of our c ourt, that Article III bars such a remedy unless “a reasonable apprehension of imminent suit” exists is incorrect. Teva Pharm. USA, Inc. v. Pfizer, Inc. , 395 F.3d 1324, 1333 (Fed. Cir. 2005). I dissent from the denial of rehearing en banc

. I The plain language of the 2003 Medicare Amendments requires that in the Hatch-Waxman context the federal courts allow declaratory judgment actions to the full

ex tent allowed by Article III. 35 U.S.C.A. § 271(e)(5) (“[C] ourts of the United States shall, to the extent consist ent with the Constitution, have s ubject matter jurisdiction in any action brought . . . under section 2201 of ti tle 28 for a declaratory judgment that such patent is invalid or not infringed.”). Ev en if the legislative hi story could be read as approving our reasonable apprehension test, that history cannot overcome the plain language of the statute. So we must dec ide whether Article III is satisfied. There are relatively few Supreme Court cases dealing with Article III and declaratory judgments, but the few cases that do exist provide no support for a reasonable apprehension of imminent suit r equirement. The declaratory judgment statute was designed to deal with a situat ion in which the declaratory judgment defendant declined to bring suit, i.e., in which there was no r easonable apprehension of imminent suit. The Supreme Court case upholding the statute involved just such a situation—one in which there was no imminent ri sk of suit because the potential plaintiff

04-1186 2declined to sue. Aetna Life Ins. Co v. Haworth , 300 U.S. 227 (1937). In that case, the insured on several policies stopped maki ng premium payments and made repeated claims for benefits on account of total and permanent disability. Id. at 237-38. Aetna refused to pay benefits because it contended that t he insured was not disabled and that the policies had lapsed due to nonpayment. Id. at 238. The insured failed to bring suit, so Aetna filed for a declaratory judgment that the insured was not disabled and that the policies had lapsed. Id. at 239. The Court found that these facts gave rise to a controversy within the meaning of Article III, stating “[t]here is here a dispute between parties who face each other in an adversary proceeding. . . . The dispute is defined and concrete, not hypothetical or abstract. . . . It calls, not for an advisory opinion upon a hypothetical basis, but for an adjudication of present right upon established facts.” Id. at
242. Likewise, the Ninth Circuit, in a case in which the plaintiff faced a risk of liability rather than suit, has held that “[a]n action for a declaratory judgment

. . . is a case or controversy if the plaintiff has a r eal and reasonable apprehension that he will be subject to liability ,” not suit. Societe de Conditionnement en Al uminium v. Hunter Eng’g Co., Inc. , 655 F.2d 938, 944 (9th Cir. 1981) (emphasis added). 1 The First Circuit has even more directly addressed the issue in Sallen v. Corinthians Licenciamentos LTDA , 273 F.3d 14 (1st Cir. 2001), and adopted a view t hat conflicts with t he panel decision in this case. There, a World Intellectual Property Organization (“WIPO”) panel found

1 That case involved a manufacturer t hat filed for declaratory judgment of invalidity of the defendant’s patent after a potentially unauthorized person working for the defendant threatened a third party with suit if the third par ty purchased the plaintiff’s equipment. Id. at 941, 944-45. The third party purchased the equipment. Id. at 941. A

04-1186 3Sallen to be a cybersquatter and ordered his domain name transferred to Corinthians Licenciamentos LTDA (“CL”). Id. at 21-22. Sallen filed suit in federal district court seeking a declaration that under United States law (which allowed a challenge to the WIPO decision) he was entit led to the domain name. Id. at 22. The district court dismissed the case because CL had no intent to sue Sallen under Un ited States law. Id. On appeal, the First Circuit rejected CL ’s argument that a reasonable apprehension of suit is required to satisfy Article III: CL claims that a reasonable appr ehension of suit is required to meet Article III’s case or controversy requirement. But this is not the only way to establish the ex is tence of a case for purposes of Article III. The reasonable apprehension of suit doctri ne exists to cabin declaratory judgment actions where the only contro versy surrounds a potential, future lawsuit. That is not this case. Id. at 25 (internal citations omitted and emphasis added). T he court found that United States law “provides a registrant who has lo st a domain name . . . wit h a cause of action for an injunction returning the domain name if the registrant can show that she is in compliance with” United States law. Id. at 26. Thus, the court found that the controversy in issue was cert ain and that “a certain contro versy renders the ‘reasonable apprehension’ question irrelevant.” Id. In my view, the First Circuit is correc t: the proper test under Article III is whether there is a present concrete controversy, and the panel here applied an incorrect test. The panel here also reached the wr ong result in this case by relying on that erroneous
test.

hold harmless provision in the contract betw een the third party and the plaintiff placed the plaintiff in reasonable apprehension of liability. Id. at 945.

04-1186 4II Here it seems to me that ther e are three potential controversies: 1. There is a potential c ontroversy over whether the ANDA filing itself was an infringement. I doubt whether this, standing alone, satisfies Article III because Pfizer seems not to care whether su ch an infringement occurred. Tex t ron Lycoming Reciprocating Engine Div., AVCO Corp. v. UAW , 523 U.S. 653, 661 (1998) (finding no constitutional controversy where the decla ratory judgment defendant had no “interest in defending the binding nature of the contract”). 2. There is also a potential controver sy over whether Teva should be allowed to manufacture and market the drug without incurring damages for infringement. The problem here is that Teva has not alleged that it intends to market or sell the drug at any time in the near future or that it is being prevented from doing so by the risk of infringement damages. Instead, Te va alleges only that the filing of its ANDA constituted technical infringement; that Pfiz er did not file suit within the 45-day per iod; that Pfizer included the ’699 patent in the Orange Book; and t hat Pfizer tends to enforce its patents through litigation. (J.A. at 52.) Unless Teva actually is about to manufacture or sell the drug, there would seem to be no case or controversy under this theory. Societe de Conditionnement , 655 F.2d at 944. 3. The third potential controversy is over whether Teva’s ANDA should be approved earlier than 180 days after Ivax commences marketing. In my view, there is a present and concrete controversy over Teva’s right to such an approval, which satisfies the requirements of Article III. The Hatch- Wax m an Amendments provide for the right to secure resolution of the controversy through a declaratory judgment.

04-1186 5Ivax earlier filed a paragr aph IV certification regar ding the ’699 patent and then settled with Pfizer. Thus, Iv ax will enjoy a 180-day exclusiv ity period beginning with the earlier of (1) the first day it markets its generic drug (which cannot be earlier than June 30, 2006 ) or (2) the date that the ’699 patent is held invalid or not infringed in the decision of a court. 2 Because of the paragraph IV ce rtification, Teva’s application cannot be approved by the FDA until after Iv ax’s 180-day exclusivity period ends. Teva , 395 F.3d at 1328, 1330. In other words, the running of the exclusivity period could be triggered before Ivax’s first marketing date if Teva could secure a declaratory judgment of non-infringement or invalid ity. Approval of Teva’s ANDA would follow 180 days thereafter. Normally, one would expect that the approv al issue would be litigated between Teva and the FDA, but, as we recognized in Minnesota Mining and Manufacturing Co. v. Barr Laboratories, Inc. , 289 F.3d 775, 778 (Fed. Cir. 2002), Congress provided that approval would depend on the outcome of litigat ion between private par ties (the patent owner and the potential infringer) over t he questions of infringement and validity. 3 There is certainly a concrete controversy between Pfizer (and Ivax ) and Teva over when Teva’s ANDA should be approved. Both Pfiz er and Ivax want the approval of Teva’s application delayed. Teva wants to avoi d delay. The question of delay turns on

2 To be sure, Pfizer’s failure to bri ng suit within the 45- day period specified in section 21 U.S.C. § 355(j)(5 )(B)(iii) means that the approv al of the ANDA will not be delayed under that section, but despite Pfizer’s failure to sue, 21 U.S.C. § 355(j)(5)(B)(iv) will bar approv al until 180 days after Ivax markets the drug unless there is an earlier holding of non- infringement or invalidity. 3 See also Apotex, Inc. v. Thompson , 347 F.3d 1335 (Fed. Cir. 2003); Mylan Pharm., Inc. v. Thompson , 268 F.3d 1323 (Fed. Cir. 2001).

04-1186 6infringement and validity. 4 Under these circumstances, I think there is a case or controversy within the meaning of Article III, and that the questions of infringement and validity should be addressed. The panel appear s to recognize the existence of a controversy, but holds that the controver sy is insufficient for purposes of Article III. 5 I respectfully disagree. Under the panel’s decis ion Teva lacks any remedy to contest the delay in its ANDA approval. I agree with Judge Mayer and Judge Gajarsa that Article III does not require such unfairness.

4 While the ’518 patent imposes an additi onal limitation on the approval of Teva’s ANDA such that it could not be approved until the ’518 patent expires (June 30, 2006), it is hardly prematur e to litigate the approval date since litigation over infringement and invalidity of the ’699 patent could itself consume a significant time. 5 The panel states that “[t]he fact that Teva is disadvantaged from a business standpoint by Ivax’s 180-day exclusiv ity period and the fa ct that Pfizer’s decision not to sue Teva creates an impediment to Teva’s removing that disadvantage are matters separate and distinct from whether an Article III controversy ex ists between Teva and Pfizer.” Teva , 395 F.3d at 1338.

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