No. 08-624

Supr~me Co~m’t, U.S.

I OFFICE O~ ~HE CLERK

IN THE

FOREST LABORATORIES, INC., FOREST LABORATORIESHOLDINGS, LTD., AND H. LUNDBECKA/S,

Petitioners,V.

CARACO PHARMACEUTICAL LABOR ,TORIES, LTD.,

Respondent.

On Petition for Writ of Certiorari to theUnited States Court of Appeals for the

Federal Circuit

BRIEF OF IVAX PHARMACEUTICALS, INC.AS AMICUS CURIAE IN SUPPORT OF

PETITIONERS

December 10, 2008

HENRY DINGER, P.C.Counsel of Record

GOODWIN PROCTER LLPExchange Place53 State StreetBoston, MA 02109(617) 570-1276

WILSON-EPE$ PRINTING CO., INC. - (202) 789-0096 - WASHINGTON, D. C. 20002

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QUESTIONS PRESENTED(I) Whether the Federal Circuit erred, and

deepened confusion among the lower courts, byholding that a declaratory-judgment plaintiffcan establish traceability for purposes of ArticleIII standing simply by alleging. "but-for"causation between some action or conduct bythe defendant and the plaintiffs asserted injury.

(II) Whether the Federal Circuit erred by holdingthat a declaratory-judgment plaintiff hasstanding where the plaintiffs complaint doesnot challenge the legality of the particularaction or conduct alleged to have caused theplaintiffs asserted injury~

oo,111

CORPORATE DISCLOSURE STATEMENT

Pursuant to Rule 29.6 of the Rules of this Court,Ivax Pharmaceuticals, Inc. hereby states that it is adirect, wholly-owned subsidiary of Ivax Corporation,which is, in turn, wholly owned through thefollowing chain: Teva Pharmaceuticals USA, Inc.,Orvet UK Unlimited, Teva Pharmaceuticals EuropeB.V., then Teva Pharmaceutical Industries Ltd.Teva Pharmaceutical Industries Ltd. is the onlypublicly traded parent company of IvaxPharmaceuticals, Inc. and no publicly-tradedcompany owns more than 10 percent of its stock.

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TABLE OF CONTENTS

Page

QUESTIONS PRESENTED .......................................ii

CORPORATE DISCLOSURE STATEMENT ..........iii

TABLE OF AUTHORITIES ........................................v

STATEMENT OF INTEREST ....................................1

INTRODUCTION AND SUMMARY OF THEARGUMENT. ..............................................................4

REASONS FOR GRANTING THE WRIT ..................9

I. The Federal Circuit Erred, And DeepenedConfusion Among The Lower Courts, t~y HoldingThat A Declaratory-Judgment Plaintiff CanEstablish Traceability For Purposes Of Article IIIStanding Simply By Alleging "But-For" CausationBetween Some Action Or Conduct By TheDefendant And The Plaintiffs Asserted Injury .........9

II. The Federal Circuit Erred By Holding ThatA Declaratory-Judgment Plaintiff Has StandingWhere The Plaintiffs Complaint Does NotChallenge The Legality Of The Particular ActionOr Conduct Alleged To Have Caused ThePlaintiffs Asserted Injury .........................................17

CONCLUSION ..........................................................21

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TABLE OF AUTHORITIES

Page(s)Cases

aaiPharma Inc. v. Thompson,296 F.3d 227 (4th Cir. 2002) ..........................21

Allen v. Wright,468 U.S. 737 (1984) ...............................9, 15, 17

Duke Power Co. v. Carolina Envtl. Study Group, Inc.,438 U.S. 59 (1978) .................... 6, 11, 13, 14, 15

Focus on the Family v. Pinellas Suncoast TransitAuth.,344 F.3d 1263 (llth Cir. 2003) .................. 7, 13

Friends of the Earth, Inc. v. Laidlaw Envtl. Servs.(TOC), Inc.,528 U.S. 167 (2000) ...............................9, 17, 20

Fulani v. Brady,935 F.2d 1324 (D.C. Cir. 1991) ............., .....7, 12

Fulani v. League of Women Voters Educ. Fund,882 F.2d 621 (2d Cir. 1989) ........................7, 12

Gladstone, Realtors v. Village of l~lellwood,441 U.S. 91 (1979) ...........................................17

Huddy v. F.C.C.,236 F.3d 720 (D.C. Cir, 2001) .........................13

In re Buspirone Patent Litig.,185 F. Supp. 2d 363 (S.D.N.Y. 2002) .............21

Janssen Pharmaceutica, N. V. v. Apotex, Inc.,

540 F.3d 1353 (Fed. Cir. 2008) ..........................3

Lujan v. Defenders of Wildlife,504 U.S. 555 (1992) ............................... 9, 10, 17

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Ne. Fla. Chapter of Ass’d Gen. Contractors of Am.,508 U.S. 656 (1993) .........................................10

Nova Health Sys. v. Gandy,416 F.3d 1149 (10th Cir. 2005) ................... 7, 13

Shoreham- Wading River Cent. School Dist. v. U.S.Nuclear Regulatory Comm’n,931 F.2d 102 (D.C. Cir. 1991) .....................7, 12

Simon v. E. Ky. Welfare Rights Org.,426 U.S. 26 (1976) ............................6, 7, 10, 14

Steel Co. v. Citizens for a Better Env’t,523 U.S. 83 (1998) ..........................9, 15, 17, 20

Teva Pharms. USA, Inc. Novartis Pharms. Corp.,482 F.3d 1330 (Fed. Cir. 2007) .........................2

The Pitt News v. Fisher,215 F.3d 354 (3d Cir. 2000) ........................7, 11

Warth v. Seldin,422 U.S. 490 (1975) ...........................................6

Xechem, Inc. v. Bristol-Myers Squibb Co.,372 F.3d 899 (7th Cir. 2004) ..........................21

Statutes and Regulations

21 U.S.C.

21 U.S.C.

21 U.S.C.

21 U.S.C.

28 U.S.C.

28 U.S.C.

§ 355(b)(1) .................................................19

§ 355(j)(5)(B)(iv) ....................................1, 21

§ 355(j)(5)(B)(iv)(II) .....................................2

§ 355(j)(5)(C) .........................................2, 19

§ 2201 ........................................................19

§ 2202 ........................................................19

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Drug Price Competition and Patent TermRestoration Act,Pub. L. No. 98-417, 98 Stat. 1585 (1984) .........1

Medicare Prescription Drug, Improvement, andModernization Act of 2003,Pub. L. No. 108-173, 117 Stat. 2066 (2003) .....1

Rules and Other Authorities

C. Wright, Law of Federal Courts § 13 (4th ed. 1983)

STATEMENT OF INTEREST1

Ivax Pharmaceuticals, Inc. ("Ivax") holdstentatively approved Abbreviated New DrugApplication ("ANDA") No. 76-765 for genericescitalopram oxalate tablets ("EO") in 5-, 10-, and 20-mg dosages. Because Ivax was the first generic EOapplicant to challenge petitioner Forest’s U.S. PatentNo. 6,916,941. ("the ’941 patent"), Ivax is entitled to a180-day period of marketing exclusivity for genericEO under 21 U.S.C. § 355(j)(5)(B)(iv).2

As the court below recognized, respondentCaraco’s declaratory judgment action whichrequests a judgment that its EO products do notinfringe the ’941 patent, even though petitionerForest has covenanted never to assert the ’941patent against Caraco seeks to trigger Ivax’smarketing exclusivity before Ivax ever has an

1 All parties have consented to the filing of this brief, and

letters evincing such consent have been fried with the Clerk.Pursuant to this Court’s Rule 37.6, amicus states that noattorney for a party authored any part of this brief and thatneither such attorney, nor any party, nor any person or entityother than amicus, its members, or its attorneys made amonetary contribution intended to fund the preparation orsubmission of this brief.

2 This statute was enacted as part of the Drug Price

Competition and Patent Term Restoration Act, Pub. L. No. 98-417, 98 Stat. 1585 (1984) (codified at 21 U.S.C. §§ 355, 360(cc)(2000)), as amended by the Medicare Prescription Drug,Improvement, and Modernization Act of 2003, Pub. L. No. 108-173, 117 Stat. 2066 (2003). This legislation is commonly

referred to as the "Hatch-Waxman Act," as lvax will refer to itin this brief.

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opportunity to take advantage of that statutoryreward. Pet. App. 28a ("A favorable judgment in thiscase would clear the path to FDA approval thatForest’s actions would otherwise deny Caraco --namely, using the court-judgment trigger of 21U.S.C. § 355(j)(5)(B)(iv)(II) (2000) to activate Ivax’sexclusivity period."). Ivax has a clear interest inpreserving its legal entitlement to marketingexclusivity, and, thus, in the outcome of this case.

This case also presents recurring issues that arelikely to have a significant long-term impact onIvax’s business, the generic pharmaceutical industryas a whole, and the federal courts. When Congressamended the Hatch-Waxman Act to create what itcalled a "civil action to obtain patent certainty," 21U.S.C. § 355(j)(5)(C), this case decidedly was notwhat it had in mind. As the terminology employedby Congress suggests, that provision was intended toreduce delays in the resolution of genuine patentdisputes between pharmaceutical manufacturersbecause Congress recognized that patent uncertaintyitself often deters the launch of generic drugs evenof generic drugs that have received FDA approval.See Teva Pharms. USA, Inc. Nowwtis Pharms. Corp.,482 F.3d 1330, 1342-44 (Fed. Cir. 2007).

Caraco, however, faces no patent uncertainty inthis case, because Forest’s covenant not to assert the’941 patent means both that Caraco’s FDA approvalis not blocked by that patent and that Caraco facesno conceivable patent liability for launching its EOproducts. As a result, the decision below threatensto burden the courts with contrived patentinfringement cases and, thus, to delay the resolution

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of genuine patent disputes like the many in whichIvax currently is involved.

But the decision below will do far more thanpermit litigants to clog the federal courts withunnecessary claims. It will fundamentallyundermine one of the Act’s most important features:180 days of marketing exclusivity for the firstgeneric applicant to challenge a pharmaceuticalpatent that otherwise would block the introduction ofgeneric competition. When Congress enacted thestatute, it deliberately chose to reward that firstgeneric applicant with a period of marketingexclusivity in order to encourage generic companiesto undertake the significant expense associated withdeveloping a generic product and to assume the risksassociated with high-stakes patent litigation. See,e.g., Janssen Pharmaceutica, N.V. v. Apotex, Inc., 540F.3d 1353; 1361 (Fed. Cir. 2008) ("The 180-dayexclusivity period is important to genericpharmaceutical companies as it promotes patentchallenges by enabling a generic company a period torecover its investment in these challenges."). Theappellate court’s decision in this case, however,encourages subsequent generic applicants to knockout the first-flier’s exclusivity by challenging apatent that the brand manufacturer has (validly andenforceably) pledged never to assert against thesubsequent generic applicant.

This Court thus should have no illusions aboutthe consequences of the panel’s decision. If genericcompanies can bring declaratory judgment actionsdirected at patents that cannot be enforced againstthem, and by so doing eliminate a competitor’smarketing exclusivity, they will do so at every

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opportunity. That not only will undercut thestatutory incentive scheme by rendering the 180-dayexclusivity period vulnerable to manipulative patentlitigation by third parties reducing the incentivefor generic manufacturers to file paragraph IVcertifications in the first place, and thereby Slowingthe onset of generic competition over the long runbut also will flood the courts with burdensome patentcases where nothing is at stake because the patents-in-suit never will (and never can) be asserted againstthe plaintiff that challenges them. Beyond itsspecific interest in this case, then., Ivax has a stronginterest in protecting the exclusivity incentiveagainst unproductive, self-serving, and shortsightedchallenges like Caraco’s.

INTRODUCTION AND SUMMARY OFTHE ARGUMENT

The Federal Circuit’s decision in this casestretches the boundaries of Article III beyond thebreaking point, and opens the door to contrivedlitigation over questions not genuinely in dispute. Inthe process, the Federal Circuit contributed to thelower courts’ deep and abiding confusion over thisCourt’s standing jurisprudence, and took aim at oneof the most important features of the Hatch-WaxmanAct the 180-day period of marketing exclusivityawarded to the first generic drug applicant thatchallenges a brand-manufacturer’s pharmaceuticalpatents.

If left intact, the appellate court’s overlyexpansive view of Article III jurisdiction wouldunde rmine a statutory incentive that many believe tobe responsible for hundreds of billions of dollars inhealthcare savings over the past two decades, with

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dire consequences for the millions of patients whodepend on safe and affordable generic medications totreat their illnesses. While the broad jurisdictionalimplications of the Federal Circuit’s decision wouldwarrant this Court’s review in their own right, thefact that they arise in this particular context makesreview in this case imperative.

The issues raised by the Federal Circuit’s decisioncut. to the heart of the Constitution’s standingrequirements~ First, the appellate court erred, andin the process deepened confusion among the lowercourts, by holding that mere but-for causationbetween a defendant’s actions and the plaintiffsasserted injuries invariably suffices to establish the"traceability" requirement of Article III standing. Inparticular, the Federal Circuit held in this case thatCaraco’s asserted injury -- namely, that Ivax’sstatutory right to marketing exclusivity temporarilybars FDA from approving Caraco’s ANDA wassufficiently "traceable to Forest" because Forest’sdecision to list the ’941 patent in FDA’s official list ofdrug-claiming patents (the "Orange Book") gave Ivaxthe chance to garner the allegedly injuriousexclusivity period by filing the first patent-challenging "Paragraph IV" certification to the ’941patent. Pet. App. 26a (capitalization omitted).

The problem with that analysis is that Ivax’sintervening actions fundamentally sever the chain ofcausation between Forest’s initial patent-listingdecision and Caraco’s asserted injury. After all, asthe Federal Circuit itself recognized, Caraco is"injured" by Ivax’s statutory exclusivity period onlybecause Ivax, which is not a party to this case, filedthe first Paragraph IV certification to the ’941 patent

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(Caraco was seventh). Pet. App. 16a, 19a-20a. HadCaraco filed the first Paragraph IV certification tothe ’941 patent instead of sitting on its rights,Forest’s patent-listing decision would not haveinjured Caraco at all; instead, Caraco would haveearned the very exclusivity period about which itcomplains.

The appellate court, however, held that that clearbreak in the causal chain between Forest’s allegedly-injurious conduct and Caraco’s asserted injury wasconstitutionally irrelevant simply because Forest’sinitial decision to list the ’941 patent was a "but-forcause" of Caraco’s asserted injury. Pet. App. 26a("Such but-for causation is sufficient to satisfy thetraceability requirement of Article III standing.")(citing Duke Power Co. v. Cara, lina Envtl. StudyGroup, Inc., 438 U.S. 59, 74-78, 81 n.26 (1978)).

That was error. Indeed, this Court long has heldthat even where a defendant’s actions contributeto a plaintiffs injury -- the plaintiff lacks standingwhere the asserted "injury ... results from theindependent action of some third party not be fore thecourt." Simon v. E. Ky. Welfare Rights Org., 426 U.S.26, 41-42 (1976); Warth v. Seldin, 422 U.S. 490, 504-05 (1975). That, of course, perfectly describes whathappened in this case: Caraco’s injury results onlyfrom Ivax’s independent filing of the first ParagraphIV certification to the ’941 patent (and then onlybecause Forest also covenanted not to sue Caraco forinfringing the ’941 patent).

Even so, the Federal Circuit’s confusion is insome respects understandable. Notwithstanding thisCourt’s decisions in Simon and Warth, severalappellate courts have (just like the Federal Circuit in

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this case) misread subsequent decisions by thisCourt to hold that mere but-for causation is all thatstanding’s "traceability" requirement demands. See,e.g., The Pitt News v. Fisher, 215 F.3d 354, 361 (3dCir. 2000); Fulani v. League of Women Voters Educ.Fund [Fulani I], 882 F.2d 621, 628 (2d Cir. 1989).

The result is a three-way circuit split, with somecourts holding that but-for causation is all that’snecessary to establish traceability (e.g., the SecondCircuit in Fulani I, the Third Circuit in Pitt News,and the Federal Circuit in this case); some holdingthat mere but-for causation is not alone sufficient toestablish traceability (e.g., the D.C. Circuit in Fulaniv. Brady [Fulani II], 935 F.2d 1324, 1329 (D.C. Cir.1991) and Shoreham-Wading River Cent. SchoolDist. v. U.S. Nuclear Regulatory Comm’n, 931 F.2d102, 105 (D.C. Cir. 1991)); and still others holdingthat "something~’ between but-for causation andproximate cause is required (e.g., the Tenth Circuitin Nova Health Sys. v. Gandy, 416 F.3d 1149, 1156(10th Cir. 2005), and the Eleventh Circuit in Focuson the Family v. Pinellas Suncoast Transit Auth.,344 F.3d 1263, 1273 (11th Cir. 2003)).

This case thus offers an excellent opportunity toresolve the lower courts’ deep and abiding confusionover the proper test for establishing traceabilityunder Article III by affirming the bedrock principlethat traceability cannot be shown where theplaintiffs "injury ... results from the independentaction of some third party not before the court,"whether or not some prior action by the defendant isa but-for cause of that injury. Simon, 426 U.S. at 41-42.

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Even if the lower courts were not hopelesslyconfused over whether but-for causation is sufficientto establish traceability, review still would bewarranted here because the Federal Circuit furthererred by holding that a dec, laratory-judgmentplaintiff has standing even though the plaintiffscomplaint does not actually challenge the legality ofthe particular action or conduct alleged to havecaused the plaintiffs asserted injury. As set forthabove, the Federal Circuit held that Caraco hadstanding to pursue this action against Forest solelybecause Forest’s decision to list the ’941 patent inFDA’s Orange Book eventually contributed toCaraco’s asserted injury namely, the fact thatIvax’s statutory exclusivity (which is based on the’941 patent) temporarily will keep Caraco off themarket.

The key point here, however, is that Caraco’scomplaint does not remotely allege (much less seek ajudgment) that Forest’s decision to list the ’941patent in FDA’s Orange Book was itself unlawful,illegitimate, or otherwise improper. Instead,Caraco’s complaint merely seeks a declaratoryjudgment that its proposed generic EO productswould not infringe the ’941 patent. That question isfundamentally distinct from the issue of whetherForest properly listed the ’941 patent in the OrangeBook; indeed, the question of whether a genericapplicant’s drug products would infringe a listedpatent has no bearing at all on whether the brand-name manufacturer properly listed that patent inthe first place.

As a result, the Federal Circuit’s decisionsquarely conflicts with a long line of cases holding

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that the plaintiffs asserted injury must be based on"the defendant’s allegedly unlawful conducf’ in orderto ground standing under Article III. Allen v.Wright, 468 U.S. 737, 751 (1984) (emphasis added);see also Friends of the Earth, Inc. v. Laidlaw Envtl.Servs. (TOC), Inc., 528 U.S. 167, 180 (2000); Steel Co.v. Citizens for a Better Env’t, 523 U.S. 83, 103 (1998);Lujan v. Defenders of Wildlife, 504’ U.S. 555, 560-61(1992)).

That requirement is no mere technicality: it is theessential prerequisite to an Article III case orcontroversy. After all, the Framers did not establisha federal Judiciary to remediate concededly lawfulinjuries; they established the federal courts toredress alleged legal wrongs. The Federal Circuit’scontrary approach effectively writes the case-or-controversy requirement out of the Constitution, andeffectively will require already-overburdened districtcourts to busy themselves rendering the very sort ofadvisory opinions that this Court has long foresworn.

The petition should be granted, and the FederalCircuit’s decision reversed.

REASONS FOR GRANTING THE WRIT

I. The Federal Circuit Erred, And DeepenedConfusion Among The Lower Courts, ByHolding That A Declaratory-JudgmentPlaintiff Can Establish Traceability ForPurposes Of Article III Standing Simply ByAlleging "But-For" Causation Between SomeAction Or Conduct By The Defendant AndThe Plaintiff’s Asserted Injury.

The Federal Circuit erred, and deepenedconfusion among the lower courts, by holding that a

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declaratory-judgment plaintiff can establishtraceability for purposes of Ax’ticle III standingsimply by alleging "but-for" causation between someaction or conduct by the defendant and the plaintiffsasserted injury. Indeed, this ,Court held nearlythirty years ago that Article III standing "requiresthat a federal court act only to redress injury thatfairly can be traced to the challenged action of thedefendant, and not injury that results from theindependent action of some third party not before thecourt." Simon, 426 U.S. at 41-42 (emphasis added);see also Lujan, 504 U/S. at 560-6:[ ("[T]here must bea causal connection between the injury and theconduct complained of the injutry has to be ’fairlytraceable to the challenged action of the defendant,and not the result of the independent action of somethird party not before the court.’") (quoting Simon;alterations omitted; emphasis added).

That perfectly describes what happened in thiscase. Caraco’s asserted injury its inability tosecure immediate FDA approval as a result of Ivax’sstatutory exclusivity period can be traced back toForest’s initial patent-listing decision only becausethird-party Ivax challenged Forest’s listed patentsbefore any other applicant and thereby earned 180-day exclusivity under the Hatch-Waxman Act.Accordingly, Caraco’s injury unquestionably "resultsfrom the independent actions of some third party notbefore the court," and Caraco thus lacks standing topursue its declaratory claims against Forest. Simon,426 U.S. at 41-42; Ne. Fla. Chapter of Ass’d Gen.Contractors of Am., 508 U.S. 656, 663 (1993) ("[A]party seeking to invoke a federal court’s jurisdictionmust demonstrate ... a causal relationship betweenthe injury and the challenged conduct, by which we

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mean that the injury fairly can be traced to thechallenged action of the defendant, and has notresulted from the independent action of some thirdparty not before the court.") (internal quotationomitted) (emphasis added).

The Federal Circuit nonetheless held thatCaraco’s injury was sufficiently traceable to Forestsimply because Forest’s initial decision to list the’941 patent was a "but-for cause" of Caraco’s assertedinjury, and "[s]uch but-for causation is sufficient tosatisfy the traceability requirement of Article IIIstanding." Pet. App. 26a (citing Duke Power, 438U.S. at 74-78, 81 n.26). That holding lays bare thedeep and abiding confusion among the lower courtsover this Court’s standing jurisprudence, and, inparticular, over the strength of the causal connectionthat must be shown between a defendant’s actionsand the plaintiffs asserted injury in order todemonstrate traceability for purposes of Article IIIstanding. The Federal Circuit’s simplistic holding onthis point that "but-for" causation is all thatArticle III’s "traceability" requirement demands isnot faithful to this Court’s precedents, and directlyconflicts with the decisions of other circuit courts.

lndeed, the Federal Circuit’s holding on this pointexacerbates a three-way split between the lowercourts on precisely this point. The Second and ThirdCircuits have held -- like the Federal Circuit herethat but-for causation alone suffices to establishestraceability for purposes of Article III’s standingrequirement. See The Pitt News, 215 F.3d at 360-61("We ... conclude that the injury alleged ... is fairlytraceable to the enforcement of [the challenged law].To analogize this situation to a familiar example in

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tort law, the enforcement of [the challenged statute]was the cause-in-fact of the financial impact felt by[plaintiff]. ’But for’ this enforceraent, its advertiserswould not have canceled their contracts."); Fulani I,882 F.2d at 628 ("But for the government’s refusal torevoke the [private defendant’s] tax-exempt status,then, [the private defendant], as a practical matter,would have been unable to sponsor the allegedlypartisan debates which caused the injury of which[plaintiff] complains. [W]e conclude that there is anexus between the federal defendants’ tax treatmentof the [private defendant] and IIplaintiff]’s assertedinjuries which enables [plaintiff] to trace her injurydirectly back to such federal defendants’ taxtreatment of the [private defendant].") (emphasis inoriginal).

On the other hand, the D.C. Circuit squarely hasrejected the proposition (and ,expressly disagreedwith its sister circuits) that but-for causation alone issufficient to demonstrate traceability where thereare "intervening causal factors." See, e.g., Fulani II,935 F.2d at 1329 ("[In Fulani 1] the Second Circuitgranted [plaintiff] standing to challenge the [privatedefendant]’s tax-exempt status because ’but for thegovernment’s refusal to revoke the League’s tax-exempt status, the [private defendant] would havebeen unable to sponsor the allegedly partisandebates which caused the injury of which [plaintiff]complains’ .... By taking [federal action] as a given,however, the Second Circuit ignores the fact that thealleged traceability and redressability may be foundin [Fulani 1] -- and could be found in the presentcase only in combination, with signfficantintervening causal factors.") (quoting Fulani I); seealso Shoreham-Wading River Cent. Sch. Dist., 931

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F.2d at 105 ("While the ban on refueling may be a’but for’ cause of any such future rulings and thus ofany resulting risks, the exemptions themselves willbe the operative causes. The link with the refuelingban is simply too remote."); cf. Huddy v. F.C.C., 236F.3d 720, 724 (D.C. Cir. 2001) ("We question whether’but for’ causation of this sort could ever be sufficientto confer constitutional standing .... It seemsimprobable that the Court intends all its learning onconstitutional standing to be so readily evaded.").

Finally, the Tenth and Eleventh Circuits haveessentially thrown up their hands and declared that"something" between but-for causation andproximate cause is required to show traceability.See, e.g., Nova Health Sys., 416 F.3d at 1156 ("Asother courts have noted, Article III’s causationrequirement demands something less than theconcept of proximate cause. Yet Article III does atleast require proof of a substantial likelihood thatthe defendant’s conduct caused plaintiffs injury infact.") (citing Focus on the Family, 344 F.3d at 1273;quotation omitted)).

In fairness to the lower courts, however, much oftheir confusion on this point stems from tensionwithin this Court’s own precedents on traceability --and, in particular, on this Court’s decision in DukePower. In that case, plaintiff environmental groupsand residents of an area surrounding a proposednuclear power plant brought suit against the NuclearRegulatory Commission ("NRC") and the operator ofa proposed nuclear power plant, seeking adeclaratory judgment that the Price Anderson Act("PAA") unconstitutionally limited the liability ofnuclear operators and effectuated a "taking~’ of the

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plaintiffs’ property in violation of the FifthAmendment. 438 U.S. at 69. To support thoseclaims, plaintiffs alleged (among other things) thatthe proposed plant could not be; constructed in theabsence of the PAA’s liability cap, and that theplant’s operation invariably would emit low-levelradiation that would harm the local environment andreduce surrounding property values. Id. at 73.

The Duke Power Court began its standinganalysis by holding that plaintiffs’ asserted injurieswere legally cognizable. Id. at 73-74: But when theCourt turned to the next prong of the standinganalysis -- traceability it immediately conflatedthat requirement with redressability. "The moredifficult step in the standing inquiry is establishingthat these injuries ’fairly can be traced to thechallenged action of the defendant,’ or put otherwise,that the exercise of the Court’s remedial powerswould redress the claimed injuries." Id. at 74(quoting Simon, 426 U.S. at 41) (emphasis added). Itthen agreed with the district court’s factual findingsand legal conclusion that the latter testredressability -- was satisfied because "Duke wouldnot be able. to complete the construction andmaintain the operation of the [proposed plants] butfor the protection provided by the [PAA]." Id. at 74-75 (quoting district court opiniol.~); id. at 75 & n.20("These findings ... if accepted ... would likely satisfythe second prong of the constitutional test forstanding as elaborated in Simon,. Our recent caseshave required no more than a showing that there is a’substantial likelihood’ that the relief requested willredress the injury claimed to satisfy the second prongof the constitutional standing requirement.") (citinginter alia Simon, 426 U.S. at 38; emphasis added).

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Since Duke Power, of course, this Court has madeclear that traceability and redressability are distinctrequirements. Steel Co., 523 U.S. at 106 n.7 ("[Thedissent] also seems to suggest that redressabilityalways exists when the defendant has directlyinjured the plaintiff. If that were so, theredressability requirement would be entirelysuperfluous, since the causation requirement askswhether the injury is ’fairly ... traceable to thechallenged action of the defendant, and not ... theresult of the independent action of some third partynot before the court.’") (alterations omitted); Allen,468 U.S. at 753 n.19 ("The ’fairly traceable’ and’redressability’ components of the constitutionalstanding inquiry were initially articulated by thisCourt as ’two facets of a single causationrequirement.’ C. Wright, Law of Federal Courts § 13,p. 68, n. 43 (4th ed. 1983). [But] the formerexamines the causal connection between theassertedly unlawful conduct and the alleged injury,whereas the latter examines the causal connectionbetween the alleged injury and the judicial reliefrequested. Cases such as this, in which the reliefrequested goes well beyond the violation of lawalleged, illustrate why it is important to keep theinquiries separate.").

Yet Duke Power’s unclear approach continues toproduce confusion among the lower courts, with some(including the court in this case) improperly applyingDuke Power’s "but-for" redressability analysis in thecourse of assessing traceability and then ignoring thesignificance of intervening breaks in the causalchain. Indeed, this case perfectly illustrates thepointl No one disputes that Caraco’s injury would beredressed if it obtained a judgment that its proposed

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EO products would not infringe Forest’s ’941 patent.After all, such a judgment would trigger Ivax’sstatutory exclusivity period, and once that 180-dayperiod expires, Caraco would be free to enter themarket. Pet. App. 27a-28a.

But the fact that litigation success will redressCaraco’s asserted injury does not suffice todemonstrate the existence of a sufficiently traceablelink between the plaintiffs injury and defendant’sconduct. Instead, to reiterate, Caraco’s assertedinjury in this case was not caused in any meaningfulsense by Forest’s patent-listing decision; it wasinstead caused by the fact that Ivax beat Caraco tothe punch, and thereby earned the allegedlyinjurious marketing exclusivity period by filing thefirst Paragraph IV certification to the ’941 patent.Under these circumstances, Ivax’s interveningactions fundamentally sever the link betweenForest’s patent-listing decision and Caraco’s injury.Regardless of whether this suit might redress thoseinjuries, Caraco cannot pin the blame ~br itspredicament on Forest and thus lacks Article IIIstanding to pursue its declaratory claims againstForest.

This case therefore presents an ideal opportunityto clarify this Court’s traceability jurisprudence andto correct the Federal Circuit’s erroneous and overlysimplistic holding that "but for" causation is thebeginning and the end of that in~quiry. Interventionis critical in this area to remedy the lower courts’deep and abiding confusion and preserve Article III’score limits on the exercise of federal jurisdiction.

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II. The Federal Circuit Erred By Holding ThatA Declaratory-Judgment Plaintiff HasStanding Where The Plaintiff’s ComplaintDoes Not Challenge The Legality Of TheParticular Action Or Conduct Alleged ToHave Caused The Plaintiffs Asserted Injury.

Even if naked but-for causation were sufficient todemonstrate traceability, the Federal Circuit furthererred by holding that a declaratory-judgmentplaintiff has standing where the plaintiffs complaintdoes not challenge the legality of the particularaction or conduct alleged to be responsible for theplaintiffs asserted injury. Indeed, this Courtrepeatedly has held that Article III standing requiresthe plaintiffs suit to present precisely such achallenge. See, e.g., Friends of the Earth, Inc. v.Laidlaw Envtl. Servs. (TOC), Inc., 528 U.S. 167, 180(2000) ("[T]o satisfy Article III’s standingrequirements, a plaintiff must show [that its] injuryis fairly traceable to the challenged action of thedefendant.") (emphasis added) (citing Lujan v.Defenders of Wildlife, 504 U.S. 555, 560-61 (1992));Steel Co. v. Citizens for a Better Env’t, 523 U.S. 83,103 (1998) ("IT]here must be causation--a fairlytraceable connection between the plaintiffs injuryand the complained-of conduct of the defendant.")(emphasis added); Allen v. Wright, 468 U.S. 737, 751(1984) ("A plaintiff must allege personal injury fairlytraceable to the defendant’s allegedly unlawfulconduct .... ") (emphasis added); Gladstone, Realtorsv. Village of Bellwood, 441 U.S. 91, 99 (1979)(plaintiff must "show that he personally has sufferedsome actual or threatened injury as a result of theputatively illegal conduct of the defendant")(emphasis added).

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The requirement that standing requires theplaintiff to trace its injury to conduct actuallychallenged in the litigation makes perfect sense. Ifthe Constitution permitted would-be plaintiffs toobtain a legal ruling by suing a defendant whoseconduct has allegedly made them worse offregardless of whether that conduct is the subject ofthe ruling sought or even alleged to be unlawfulthen the federal courts effectively would possessgeneral jurisdiction to issue advisory opinions thatdo not address concrete legal disputes between theplaintiff and defendant, and that are not evenpredicated on allegations of legal wrong.

That, however, is precisely what the FederalCircuit has permitted in this case. In holding thatCaraco has standing to pursue a declaratoryjudgment that its proposed generic EO productswould not infringe the ’941 patent, the FederalCircuit reasoned that "Forest’s listing of the ’941patent (the patent-in-suit) in the Orange-Bookcreates an independent barrier to the drug marketthat deprives Caraco of an economic opportunity tocompete." Pet. App. 27a; see also id. 26a (assertingthat "Caraco’s injury is traceable to Forest" because"if Forest had not listed its ... patents in the FDA’sOrange Book .... then [the statute] would notindependently delay Caraco’s ANDA from beingapproved") (capitalization omitted).

But Caraco’s lawsuit does not complain aboutForest’s decision to list the ’941 patent in the OrangeBook at all much less seek a declaratory judgmentthat Forest’s decision to list the ’941 patent in theOrange Book was unlawful. Instead, as theappellate court recognized, Caraco’s suit against

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Forest merely seeks a declaratory judgment that itsproposed generic EO productswould not infringe the’941 patent if those products were manufactured ormarketed. Id. 17a ("Caraco filed a separate actionunder the Declaratory Judgment Act, 28 U.S.C.§§ 2201, 2202, and the Hatch-Waxman [Act], 21U.S.C. § 355(j)(5)(C), seeking a declaratory judgmentthat the drug described in its ANDA does notinfringe Forest’s ’941 patent."); id. 28a n.10 ("Caracohas not sought a judgment of invalidity in thiscase.").

However, the question of whether Caraco’s EOproduct infringes the ’941 patent the only issue asto which Caraco seeks a federal court determination

is purely hypothetical in this case because Foresthas validly and enforceably promised never to assertthe ’941 patent against that product. And theconduct to which Caraco traces its asserted ArticleIII injury-in-fact, is not, and cannot be, the subject ofa legal claim in any event. Under the Hatch-Waxman Act, brand manufacturers must submit forOrange-Book listing "any patent which claims thedrug for which the [brand manufacturer sought FDAapproval] and with respect to which a claim of patentinfringement could reasonably be asserted if aperson not licensed ... engaged in the manufacture,use, or sale of the drug." 21 U.S.C. § 355(b)(1).Thus, even if one unlicensed company’s genericproduct would not infringe a listed patent (asCaraco’s product allegedly would not in this case),the brand-name drug’s manufacturer properly maylist that patent in the Orange Book so long as thepatent covers (or "claims") the brand-name drug andits owner reasonably could assert infringementclaims against some other unlicensed generic

2O

applicant. Indeed, the law requires the brandmanufacturer to do so.

The distinction between claims of non-infringement, on one hand, and claims that a brandmanufacturer improperly listed a given patent in theOrange Book, on the other, is particularly sharp inthis case. The ’941 patent claims a narrowly definedparticle size of EO, which is the active ingredient inForest’s brand-name product (Lexapro®). Whollyapart from the question presented by Caraco’sdeclaratory judgment action i.e., whether Caraco’sproposed generic product does or does not contain EOparticles of the size covered by the ’941 patent noone has ever suggested that Lexapro® does notcontain EO particles of the size claimed by the ’941patent or that Forest could not reasonably assertthat patent against an unlicensed applicant whoseproposed generic product does contain EO particlesof the size claimed in the ’941 patent.

Regardless of whether Caraco’s injury somehowcan be traced the Forest’s patent-listing decisionand as set forth above, that is far from clearForest’s legitimate decision to list the ’941 patent inthe Orange Book is not itself"the challenged ctlon,Friends of the Earth, 528 U.S. at 180, or"complained-of conduct" in Caraco’s suit, Steel Co.,523 U.S. at 103, and thus cannot give Caraco ArticleIII standing to pursue this case.

To be sure, nothing would preclude the federalcourts from exercising jurisdiction over this action ifCaraco actually were challenging Forest’s patent-listing decision. Indeed, numerous courts haverecognized that unlawful patent listings can give riseto liability under the Sherman Act, and thus have

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authorized generic applicants to bring lawsuitsasserting such claims in federal court. See, e.g.,Xechem, Inc. v. Bristol-Myers Squibb Co., 372 F.3d899, 901 (7th Cir. 2004) (recognizing an antitrustcause of action for sham Orange Book listings);aaiPharma Inc. v. Thompson, 296 F.3d 227, 243 n.8(4th Cir. 2002) (same); In re Buspirone Patent Litig.,185 F. Supp. 2d 363 (S.D.N.Y. 2002) (same). Norwould anything preclude Caraco from bringing a"civil action for patent certainty" under 21 U.S.C.§355(j)(5)(B)(iv) if it genuinely faced patentuncertainty. But this is not such a case; Caracoseeks only a declaration of non-infringement, andthat claim does not remotely depend on whetherForest’s Orange Book listing was proper in the firstinstance.

The Federal Circuit thus erred in holding that thefederal courts have jurisdiction over declaratoryjudgment actions like Caraco’s, and this Courtshould grant the writ.

CONCLUSION

For the foregoing reasons, the petition should begranted and the Federal Circuit’s judgment reversed.

HENRY DINGER, P.C.Counsel of Record

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