Amicus Curiae Brief — Forest Laboratories, Inc. v. Caraco Pharmaceutical Laboratories, Ltd. (No. 08-624)

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Supreme Coun, U.S.

\ \Y oy, DEC 10 2003

No. 08-624 OFFICE OF THE CLERK

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IN THE

Suprene Court of the United States

FOREST LABORATORIES, INC., FOREST LABORATORIES

HOLDINGS, LTD., AND H. LUNDBECK A/S,

Petitioners,

Vv.

CARACO PHARMACEUTICAL LABOR. TORIES, LTD.,

Respondent.

On Petition for Writ of Certiorari to the

United States Court of Appeals for the

Federal Circuit

BRIEF OF IVAX PHARMACEUTICALS, INC.

AS AMICUS CURIAE IN SUPPORT OF

PETITIONERS

HENRY DINGER, P.C.

Counsel of Record

GOODWIN PROCTER LLP

Exchange Place

53 State Street

Boston, MA 02109

(617) 570-1276

December 10, 2008

WiILSON-EPES PRINTING CO., INC. — (202) 789-0096 -— WASHINGTON, D. C. 20002

QUESTIONS PRESENTED

Whether the Federal Circuit erred, and

deepened confusion among the lower courts, by

holding that a declaratory-judgment plaintiff

can establish traceability for purposes of Article

III standing simply by alleging “but-for’”

causation between some action or conduct by

the defendant and the plaintiffs asserted injury.

Whether the Federal Circuit erred by holding

that a declaratory-judgment plaintiff has

standing where the plaintiffs complaint does

not challenge the legality of the particular

action or conduct alleged to have caused the

plaintiffs asserted injury.

ili

CORPORATE DISCLOSURE STATEMENT

Pursuant to Rule 29.6 of the Rules of this Court,

Ivax Pharmaceuticals, Inc. hereby states that it is a

direct, wholly-owned subsidiary of Ivax Corporation,

which is, in turn, wholly owned through the

following chain: Teva Pharmaceuticals USA, Inc.,

Orvet UK Unhmited, Teva Pharmaceuticals Europe

B.V., then Teva Pharmaceutical Industries Ltd.

Teva Pharmaceutical Industries Ltd. is the only

publicly traded parent company of § Ivax

Pharmaceuticals, Inc. and no _ publicly-traded

company owns more than 10 percent of its stock.

TABLE OF CONTENTS

Page

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CORPORATE DISCLOSURE STATEMENT .......... ili

TABLE OF AUTHORITIBEG................... ispaputietesiiasone Vv

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INTRODUCTION AND SUMMARY OF THE

PE pnsihdcdeec cinta eecddavetenetns acon 4

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

I. The Federal Circuit Erred, And Deepened

Confusion Among The Lower Courts, By Holding

That A Declaratory-Judgment Plaintiff Can

Establish Traceability For Purposes Of Article III

Standing Simply By Alleging “But-For” Causation

Between Some Action Or Conduct By The

Defendant And The Plaintiffs Asserted Injury. ........ 9

II. The Federal Circuit Erred By Holding That

A Declaratory-Judgment Plaintiff Has Standing

Where The Plaintiffs Complaint Does Not

Challenge The Legality Of The Particular Action

Or Conduct Alleged To Have Caused The

PIGSTAiET 6 AGOOTtOG TIFUTY. ......00<000sccccncceccecescrcesesesces- 17

SPINE nk tesaccivensceniciannsauchinsuvonessncsentenustiouieniny 21

TABLE OF AUTHORITIES

Page(s)

Cases

aaiPharma Inc. v. Thompson,

206 F.3d 227 Cath Cir. 2002) .......00.0..ccscccceceee: 21

Allen v. Wright,

RA Rees a” | ee 9, 15, 17

Duke Power Co. v. Carolina Envtl. Study Group, Inc.,

EIB UB. BO STR) .2cescsnsccesesesss, 6, 11, 13, 14, 15

Focus on the Family v. Pinellas Suncoast Transit

Auth.,

344 F.3d 1263 (11th Cir. 2008) ..............08. 7,43

Friends of the Earth, Inc. v. Laidlaw Enutl. Servs.

(TOC), Inc.,

Re RF BAPE Cc cicscscncsencasccavesecasens 9, 17, 20

Fulani v. Brady,

935 F.2d 1324 @).C. Cir. 1991)...............0.. q, 42

Fulani v. League of Women Voters Educ. Fund,

SEZ F.2d GE Ged Car. BGG) «q...2<00..ccc.cceccesees 4, 12

Gladstone, Realtors v. Village of Bellwood,

te IIE accent cciuts cis ba ccegevncycecawinwionwen 17

Huddy v. F.C.C.,

SOG Fe Tae CO.G. Cit. BOI)... cccvcciscessevessscses 13

In re Buspirone Patent Litig.,

185 F. Supp. 2d 363 (S.D.N.Y. 2002) ............. 21

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

640 F.3d 1863 (Ped. Cir. ZO0G) .........ccccesccccesese: 3

Lujan v. Defenders of Wildlife,

SO Uy CO OI arvensis dei ccinenctanciccss 9, 10, 17

Ne. Fla. Chapter of Ass’d Gen. Contractors of Am.,

508 U.S. 656 (1993)

Nova Health Sys. v. Gandy,

416 F.3d 1149 (10th Cir. 2005)

Shoreham-Wading River Cent. School Dist. v. U.S.

Nuclear Regulatory Comm'n,

931 F.2d 102 (D.C. Cir. 1991)

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)

The Pitt News v. Fisher,

215 F.3d 354 (3d Cir. 2000)

Warth v. Seldin,

422 U.S. 490 (1975)

Xechem, Inc. v. Bristol-Myers Squibb Co.,

372 F.3d 899 (7th Cir. 2004)

Statutes and Regulations

21 U.S.C. § 355(b)(1)

21 U.S.C. § 355(j)(5)(B)(GV) ...eccecceccecceseeseeseeeceeeeeeees 1, 21

21 U.S.C. § 355Gg)(5)(B) Gv) dD)

21 U.S.C. § 355(j)(5)(C)

a. ccunevvececeerecnsescucsaceesesaus 19

Re cnn ceecacceeccocneceacecceececeeveececcen: 19

vli

Drug Price Competition and Patent Term

Restoration Act,

Pub. L. No. 98-417, 98 Stat. 1585 (1984)......... 1

Medicare Prescription Drug, Improvement, and

Modernization 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 INTEREST!

Ivax Pharmaceuticals, Inc. (“Ivax’) holds

tentatively approved Abbreviated New Drug

Application (“ANDA”) No. 76-765 for generic

escitalopram oxalate tablets (“EO”) in 5-, 10-, and 20-

mg dosages. Because Ivax was the first generic EO

applicant to challenge petitioner Forest's U.S. Patent

No. 6,916,941 (“the ‘941 patent”), Ivax is entitled to a

180-day period of marketing exclusivity for generic

EO under 21 U.S.C. § 355(j)(5)(B)(iv).2

As the court below recognized, respondent

Caraco’s declaratory judgment action — which

requests a judgment that its EO products do not

infringe the ‘941 patent, even though petitioner

Forest has covenanted never to assert the ‘941

patent against Caraco — seeks to trigger Ivax’s

marketing exclusivity before Ivax ever has an

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

letters evincing such consent have been filed with the Clerk.

Pursuant to this Court’s Rule 37.6, amicus states that no

attorney for a party authored any part of this brief and that

neither such attorney, nor any party, nor any person or entity

other than amicus, its members, or its attorneys made a

monetary contribution intended to fund the preparation or

submission 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 [vax will refer to it

in this brief.

opportunity to take advantage of that statutory

reward. Pet. App. 28a (“A favorable judgment in this

case would clear the path to FDA approval that

Forest’s actions would otherwise deny Caraco —

namely, using the court-judgment trigger of 21

U.S.C. § 355G)(5)(B)Gv)TD (2000) to activate Ivax’s

exclusivity period.”). Ivax has a clear interest in

preserving its legal entitlement to marketing

exclusivity, and, thus, in the outcome of this case.

This case also presents recurring issues that are

likely to have a significant long-term impact on

Ivax’s business, the generic pharmaceutical industry

as a whole, and the federal courts. When Congress

amended the Hatch-Waxman Act to create what it

called a “civil action to obtain patent certainty,” 21

U.S.C. § 355G)(5)(C), this case decidedly was not

what it had in mind. As the terminology employed

by Congress suggests, that provision was intended to

reduce delays in the resolution of genuine patent

disputes between pharmaceutical manufacturers

because Congress recognized that patent uncertainty

itself often deters the launch of generic drugs — even

of generic drugs that have received FDA approval.

See Teva Pharms. USA, Inc. Novartis Pharms. Corp.,

482 F.3d 1330, 1342-44 (Fed. Cir. 2007).

Caraco, however, faces no patent uncertainty in

this case, because Forest’s covenant not to assert the

‘941 patent means both that Caraco’s FDA approval

is not blocked by that patent and that Caraco faces

no conceivable patent lability for launching its EO

products. As a result, the decision below threatens

to burden the courts with contrived patent

infringement cases and, thus, to delay the resolution

of genuine patent disputes like the many in which

Ivax currently is involved.

But the decision below will do far more than

permit litigants to clog the federal courts with

unnecessary claims. It will fundamentally

undermine one of the Act’s most important features:

180 days of marketing exclusivity for the first

generic applicant to challenge a pharmaceutical

patent that otherwise would block the introduction of

generic competition. When Congress enacted the

statute, it deliberately chose to reward that first

generic applicant with a period of marketing

exclusivity in order to encourage generic companies

to undertake the significant expense associated with

developing a generic product and to assume the risks

associated with high-stakes patent litigation. See,

e.g., Janssen Pharmaceutica, N.V. v. Apotex, Inc., 540

F.3d 1353, 1361 (Fed. Cir. 2008) (“The 180-day

exclusivity period is important to generic

pharmaceutical companies as it promotes patent

challenges by enabling a generic company a period to

recover its investment in these challenges.”). The

appellate court’s decision in this case, however,

encourages subsequent generic applicants to knock

out the first-filer’s exclusivity by challenging a

patent that the brand manufacturer has (validly and

enforceably) pledged never to assert against the

subsequent generic applicant.

This Court thus should have no ilusions about

the consequences of the panel’s decision. If generic

companies can bring declaratory judgment actions

directed at patents that cannot be enforced against

them, and by so doing eliminate a competitor’s

marketing exclusivity, they will do so at every

opportunity. That not only will undercut the

statutory incentive scheme by rendering the 180-day

exclusivity period vulnerable to manipulative patent

litigation by third parties — reducing the incentive

for generic manufacturers to file paragraph IV

certifications in the first place, and thereby slowing

the onset of generic competition over the long run —

but also will flood the courts with burdensome patent

cases where nothing is at stake because the patents-

in-suit never will (and never can) be asserted against

the plaintiff that challenges them. Beyond its

specific interest in this case, then, Ivax has a strong

interest in protecting the exclusivity incentive

against unproductive, self-serving, and shortsighted

challenges like Caraco’s.

INTRODUCTION AND SUMMARY OF

THE ARGUMENT

The Federal Circuit's decision in this case

stretches the boundaries of Article III beyond the

breaking point, and opens the door to contrived

litigation over questions not genuinely in dispute. In

the process, the Federal Circuit contributed to the

lower courts’ deep and abiding confusion over this

Court’s standing jurisprudence, and took aim at one

of the most important features of the Hatch-Waxman

Act — the 180-day period of marketing exclusivity

awarded to the first generic drug applicant that

challenges a brand-manufacturer’s pharmaceutical

patents.

If left intact, the appellate court's overly

expansive view of Article III jurisdiction would

undermine a statutory incentive that many believe to

be responsible for hundreds of billions of dollars in

healthcare savings over the past two decades, with

dire consequences for the millions of patients who

depend on safe and affordable generic medications to

treat their illnesses. While the broad jurisdictional

implications of the Federal Circuit’s decision would

warrant this Court’s review in their own right, the

fact that they arise in this particular context makes

review in this case imperative.

The issues raised by the Federal Circuit’s decision

cut to the heart of the Constitution’s standing

requirements. First, the appellate court erred, and

in the process deepened confusion among the lower

courts, by holding that mere but-for causation

between a defendant’s actions and the plaintiff's

asserted injuries invariably suffices to establish the

“traceability” requirement of Article III standing. In

particular, the Federal Circuit held in this case that

Caraco’s asserted injury — namely, that Ivax’s

statutory right to marketing exclusivity temporarily

bars FDA from approving Caraco’s ANDA — was

sufficiently “traceable to Forest” because Forest’s

decision to list the ‘941 patent in FDA’s official list of

drug-claiming patents (the “Orange Book”) gave Ivax

the chance to garner the allegedly injurious

exclusivity period by filing the first patent-

challenging “Paragraph IV” certification to the ‘941

patent. Pet. App. 26a (capitalization omitted).

The problem with that analysis is that Ivax’s

intervening actions fundamentally sever the chain of

causation between Forest’s initial patent-listing

decision and Caraco’s asserted injury. After all, as

the Federal Circuit itself recognized, Caraco is

“injured” by Ivax’s statutory exclusivity period only

because Ivax, which is not a party to this case, filed

the first Paragraph IV certification to the ‘941 patent

(Caraco was seventh). Pet. App. 16a, 19a-20a. Had

Caraco filed the first Paragraph IV certification to

the ‘941 patent instead of sitting on its rights,

Forest’s patent-listing decision would not have

injured Caraco at all; instead, Caraco would have

earned the very exclusivity period about which it

complains.

The appellate court, however, held that that clear

break in the causal chain between Forest’s allegedly-

injurious conduct and Caraco’s asserted injury was

constitutionally irrelevant simply because Forest’s

initial decision to list the ‘941 patent was a “but-for

cause” of Caraco’s asserted injury. Pet. App. 26a

(“Such but-for causation is sufficient to satisfy the

traceability requirement of Article III standing.”)

(citing Duke Power Co. v. Carolina Envtl. Study

Group, Inc., 438 U.S. 59, 74-78, 81 n.26 (1978)).

That was error. Indeed, this Court long has held

that — even where a defendant’s actions contribute

to a plaintiffs injury — the plaintiff lacks standing

where the asserted “injury ... results from the

independent action of some third party not before the

court.” 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 what

happened in this case: Caraco’s injury results only

from Ivax’s independent filing of the first Paragraph

IV certification to the ‘941 patent (and then only

because Forest also covenanted not to sue Caraco for

infringing the ‘941 patent).

Even so, the Federal Circuit's confusion is in

some respects understandable. Notwithstanding this

Court’s decisions in Simon and Warth, several

appellate courts have (just like the Federal Circuit in

this case) misread subsequent decisions by this

Court to hold that mere but-for causation is all that

standing’s “traceability” requirement demands. See,

e.g., The Pitt News v. Fisher, 215 F.3d 354, 361 (3d

Cir. 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 some

courts holding that but-for causation is all that’s

necessary to establish traceability (e.g., the Second

Circuit in Fulani I, the Third Circuit in Pitt News,

and the Federal Circuit in this case); some holding

that mere but-for causation is not alone sufficient to

establish traceability (e.g., the D.C. Circuit in Fulani

v. Brady [Fulani IT], 935 F.2d 1324, 1329 (D.C. Cir.

1991) and Shoreham-Wading River Cent. School

Dist. v. U.S. Nuclear Regulatory Comm’n, 931 F.2d

102, 105 (D.C. Cir. 1991)); and still others holding

that “something” between but-for causation and

proximate cause is required (e.g., the Tenth Circuit

in Nova Health Sys. v. Gandy, 416 F.3d 1149, 1156

(10th Cir. 2005), and the Eleventh Circuit in Focus

on the Family v. Pinellas Suncoast Transit Auth..,

344 F.3d 1263, 1273 (11th Cir. 2003)).

This case thus offers an excellent opportunity to

resolve the lower courts’ deep and abiding confusion

over the proper test for establishing traceability

under Article III by affirming the bedrock principle

that traceability cannot be shown where the

plaintiffs “injury ... results from the independent.

action of some third party not before the court,”

whether or not some prior action by the defendant is

a but-for cause of that injury. Simon, 426 U.S. at 41-

42.

Even if the lower courts were not hopelessly

confused over whether but-for causation is sufficient

to establish traceability, review still would be

warranted here because the Federal Circuit further

erred by holding that a _ declaratory-judgment

plaintiff has standing even though the plaintiffs

complaint does not actually challenge the legality of

the particular action or conduct alleged to have

caused the plaintiffs asserted injury. As set forth

above, the Federal Circuit held that Caraco had

standing to pursue this action against Forest solely

because Forest’s decision to list the ‘941 patent in

FDA’s Orange Book eventually contributed to

Caraco’s asserted injury — namely, the fact that

Ivax’s statutory exclusivity (which is based on the

‘941 patent) temporarily will keep Caraco off the

market.

The key point here, however, is that Caraco’s

complaint does not remotely allege (much less seek a

judgment) that Forest’s decision to list the ‘941

patent in FDA’s Orange Book was itself unlawful,

illegitimate, or otherwise improper. Instead,

Caraco’s complaint merely seeks a _ declaratory

judgment that its proposed generic EO products

would not infringe the ‘941 patent. That question is

fundamentally distinct from the issue of whether

Forest properly listed the ‘941 patent in the Orange

Book; indeed, the question of whether a_ generic

applicant’s drug products would infringe a listed

patent has no bearing at all on whether the brand-

name manufacturer properly listed that patent in

the first place.

As a result, the Federal Cuircurt’s decision

squarcly conflicts with a long line of cases holding

that the plaintiffs asserted injury must be based on

“the defendant’s allegedly unlawful conduct” in order

to ground standing under Article III. Allen uv.

Wright, 468 U.S. 737, 751 (1984) (emphasis added);

see also Friends of the Earth, Inc. v. Laidlaw Envtl.

Servs. (TOC), “ic., 528 U.S. 167, 180 (2000); Steel Co.

v. Citizens for a Better Env’, 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 the

essential prerequisite to an Article III case or

controversy. After all, the Framers did not establish

a federal Judiciary to remediate concededly lawful

injuries; they established the federal courts to

redress alleged legal wrongs. The Federal Circuit's

contrary approach effectively writes the case-or-

controversy requirement out of the Constitution, and

effectively will require already-overburdened district

courts to busy themselves rendering the very sort of

advisory opinions that this Court has long foresworn.

The petition should be granted, and the Federal

Circuit’s decision reversed.

REASONS FOR GRANTING THE WRIT

I. The Federal Circuit Erred, And Deepened

Confusion Among The Lower Courts, By

Holding That A_ Declaratory-Judgment

Plaintiff Can Establish Traceability For

Purposes Of Article III Standing Simply By

Alleging “But-For” Causation Between Some

Action Or Conduct By The Defendant And

The Plaintiffs Asserted Injury.

The Federal Circuit erred, and deepened

confusion among the lower courts, by holding that a

declaratory-judgment plaintiff can — establish

traceability for purposes of Article III standing

simply by alleging “but-for” causation between some

action or conduct by the defendant and the plaintiffs

asserted injury. Indeed, this Court held nearly

thirty years ago that Article III standing “requires

that a federal court act only to redress injury that

fairly can be traced to the challenged action of the

defendant, and not injury that results from the

independent action of some third party not before the

court.” Simon, 426 U.S. at 41-42 (emphasis added);

see also Lujan, 504 U.S. at 560-61 (“[T]here must be

a causal connection between the injury and the

conduct complained of — the injury has to be ‘fairly

traceable to the challenged action of the defendant,

and not the result of the independent action of some

third party not before the court.”) (quoting Simon;

alterations omitted; emphasis added).

That perfectly describes what happened in this

case. Caraco’s asserted injury — its inability to

secure immediate FDA approval as a result of Ivax’s

statutory exclusivity period — can be traced back to

Forest’s initial patent-listing decision only because

third-party Ivax challenged Forest’s listed patents

before any other applicant and thereby earned 180-

day exclusivity under the Hatch-Waxman Act.

Accordingly, Caraco’s injury unquestionably “results

from the independent actions of some third party not

before the court,” and Caraco thus lacks standing to

pursue its declaratory claims against Forest. Simon,

426 U.S. at 41-42; Ne. Fla. Chapter of Ass‘ Gen.

Contractors of Am., 508 U.S. 656, 663 (1993) (“[A]

party seeking to invoke a federal court’s jurisdiction

must demonstrate ... a causal relationship between

the injury and the challenged conduct, by which we

mean that the injury fairly can be traced to the

challenged action of the defendant, and has not

resulted from the independent action of some third

party not before the court.”) (internal quotation

omitted) (emphasis added).

The Federal Circuit nonetheless held that

Caraco’s injury was sufficiently traceable to Forest

simply because Forest’s initial decision to list the

‘941 patent was a “but-for cause” of Caraco’s asserted

injury, and “[s]uch but-for causation is sufficient to

satisfy the traceability requirement of Article III

standing.” Pet. App. 26a (citing Duke Power, 438

U.S. at 74-78, 81 n.26). That holding lays bare the

deep and abiding confusion among the lower courts

over this Court’s standing jurisprudence, and, in

particular, over the strength of the causal connection

that must be shown between a defendant’s actions

and the plaintiffs asserted injury in order to

demonstrate traceability for purposes of Article III

standing. The Federal Circuit’s simplistic holding on

this point — that “but-for” causation is all that

Article III’s “traceability” requirement demands — is

not faithful to this Court’s precedents, and directly

conflicts with the decisions of other circuit courts.

Indeed, the Federal Circuit's holding on this point

exacerbates a three-way split between the lower

courts on precisely this point. The Second and Third

Circuits have held — lke the Federal Circuit here —

that but-for causation alone suffices to establishes

traceability for purposes of Article III’s standing

requirement. See The Pitt News, 215 F.3d at 360-61

(“We ... conclude that the injury alleged ... is fairly

traceable to the enforcement of [the challenged law].

To analogize this situation to a familiar example in

tort law, the enforcement of [the challenged statute]

was the cause-in-fact of the financial impact felt by

[plaintiff]. “But for’ this enforcement, its advertisers

would not have canceled their contracts.”); Fulani I,

882 F.2d at 628 (“But for the government’s refusal to

revoke the [private defendant’s}] tax-exempt status,

then, [the private defendant], as a practical matter,

would have been unable to sponsor the allegedly

partisan debates which caused the injury of which

[plaintiff] complains. [W]e conclude that there is a

nexus between the federal defendants’ tax treatment

of the [private defendant] and [plaintiff]’s asserted

injuries which enables [plaintiff] to trace her injury

directly back to such federal defendants’ tax

treatment of the [private defendant].”) (emphasis in

original).

On the other hand, the D.C. Circuit squarely has

rejected the proposition (and expressly disagreed

with its sister circuits) that but-for causation alone is

sufficient to demonstrate traceability where there

are “intervening causal factors.” See, e.g., Fulani I,

935 F.2d at 1329 (“{In Fulani I] the Second Circuit

granted [plaintiff] standing to challenge the [private

defendant]’s tax-exempt status because ‘but for the

government’s refusal to revoke the League’s tax-

exempt status, the [private defendant] would have

been unable to sponsor the allegedly partisan

debates which caused the injury of which [plaintiff]

complains’ .... By taking [federal action] as a given,

however, the Second Circuit ignores the fact that the

alleged traceability and redressability may be found

in [Fulani I} — and could be found in the present

case — only in combination with significant

intervening causal factors.”) (quoting Fulani J); see

also Shoreham-Wading River Cent. Sch. Dist., 931

F.2d at 105 (“While the ban on refueling may be a

‘but for’ cause of any such future rulings and thus of

any resulting risks, the exemptions themselves will

be the operative causes. The link with the refueling

ban is simply too remote.”); cf. Huddy v. F.C.C., 236

F.3d 720, 724 (D.C. Cir. 2001) (“We question whether

‘but for’ causation of this sort could ever be sufficient

to confer constitutional standing.... It seems

improbable that the Court intends all its learning on

constitutional standing to be so readily evaded.”).

Finally, the Tenth and Eleventh Circuits have

essentially thrown up their hands and declared that

“something” between but-for causation and

proximate cause is required to show traceability.

See, e.g., Nova Health Sys., 416 F.3d at 1156 (“As

other courts have noted, Article III’s causation

requirement demands something less than the

concept of proximate cause. Yet Article III does at

least require proof of a substantial hkelihood that

the defendant’s conduct caused plaintiffs injury in

fact.”) (citing Focus on the Family, 344 F.3d at 1273;

quotation omitted)).

‘In fairness to the lower courts, however, much of

their confusion on this point stems-from tension

within this Court’s own precedents on traceability —

and, in particular, on this Court’s decision in Duke

Power. In that case, plaintiff environmental groups

and residents of an area surrounding a proposed

nuclear power plant brought suit against the Nuclear

Regulatory Commission (“NRC”) and the operator of

a proposed nuclear power plant, seeking a

declaratory judgment that the Price Anderson Act

(“PAA”) unconstitutionally limited the lability of

nuclear operators and effectuated a “taking” of the

plaintiffs property in violation of the Fifth

Amendment. 438 U.S. at 69. To support those

claims, plaintiffs alleged (among other things) that

the proposed plant could not be constructed in the

absence of the PAA’s liability cap, and that the

plant’s operation invariably would emit low-level

radiation that would harm the local environment and

reduce surrounding property values. Id. at 73.

The Duke Power Court began its standing

analysis by holding that plaintiffs’ asserted injuries

were legally cognizable. Jd. at 73-74. But when the

Court turned to the next prong of the standing

analysis — traceability — it immediately conflated

that requirement with redressability. “The more

difficult step in the standing inquiry is establishing

that these injuries ‘fairly can be traced to the

challenged action of the defendant,’ or put otherwise,

that the exercise of the Court’s remedial powers

would redress the claimed injuries.” Jd. at 74

(quoting Simon, 426 U.S. at 41) (emphasis added). It

then agreed with the district court’s factual findings

and legal conclusion that the latter test —

redressability — was satisfied because “Duke would

not be able to complete the construction and

maintain the operation of the [proposed plants] but

for the protection provided by the [PAA].” Jd. at 74-

75 (quoting district court opinion); id. at 75 & n.20

(“These findings ... if accepted ... would likely satisfy

the second prong of the constitutional test for

standing as elaborated in Simon. Our recent cases

have required no more than a showing that there is a

‘substantial likelihood’ that the relief requested will

redress the injury claimed to satisfy the second prong

of the constitutional standing requirement.”) (citing

inter alta Simon, 426 U.S. at 38; emphasis added).

Since Duke Power, of course, this Court has made

clear that traceability and redressability are distinct

requirements. Steel Co., 523 U.S. at 106 n.7 (“[The

dissent] also seems to suggest that redressability

always exists when the defendant has directly

injured the plaintiff. If that were so, the

redressability requirement would be entirely

superfluous, since the causation requirement asks

whether the injury is ‘fairly ... traceable to the

challenged action of the defendant, and not ... the

result of the independent action of some third party

not before the court.”’) (alterations omitted); Allen,

468 U.S. at 753 n.19 (“The ‘fairly traceable’ and

‘redressability components of the constitutional

standing inquiry were initially articulated by this

Court as ‘two facets of a _ single causation

requirement. C. Wright, Law of Federal Courts § 13,

p. 68, n. 43 (4th ed. 1983). [But] the former

examines the causal connection between the

assertedly unlawful conduct and the alleged injury,

whereas the latter examines the causal connection

between the alleged injury and the judicial relief

requested. Cases such as this, in which the relief

requested goes well beyond the violation of law

alleged, illustrate why it is important to keep the

inquiries separate.”).

Yet Duke Power’s unclear approach continues to

produce confusion among the lower courts, with some

(including the court in this case) improperly applying

Duke Power's “but-for” redressability analysis in the

course of assessing traceability and then ignoring the

significance of intervening breaks in the causal

chain. Indeed, this case perfectly illustrates the

point. No one disputes that Caraco’s injury would be

redressed if it obtained a judgment that its proposed

EO products would not infringe Forest’s ‘941 patent.

After all, such a judgment would trigger Ivax’s

statutory exclusivity period, and once that 180-day

period expires, Caraco would be free to enter the

market. Pet. App. 27a-28a.

But the fact that litigation success will redress

Caraco’s asserted injury does not suffice to

demonstrate the existence of a sufficiently traceable

link between the plaintiffs injury and defendant’s

conduct. Instead, to reiterate, Caraco’s asserted

injury in this case was not caused in any meaningful

sense by Forest’s patent-listing decision; it was

instead caused by the fact that Ivax beat Caraco to

the punch, and thereby earned the allegedly

injurious marketing exclusivity period by filing the

first Paragraph IV certification to the ‘941 patent.

Under these circumstances, Ivax’s intervening

actions fundamentally sever the link between

Forest’s patent-listing decision and Caraco’s injury.

Regardless of whether this suit might redress those

injuries, Caraco cannot pin the blame for its

predicament on Forest and thus lacks Article III

standing to pursue its declaratory claims against

Forest.

This case therefore presents an ideal opportunity

to clarify this Court’s traceability jurisprudence and

to correct the Federal Circuit’s erroneous and overly

simplistic holding that “but for” causation is the

beginning and the end of that inquiry. Intervention

is critical in this area to remedy the lower courts’

deep and abiding confusion and preserve Article III’s

core limits on the exercise of federal jurisdiction.

II. The Federal Circuit Erred By Holding That

A Declaratory-Judgment Plaintiff Has

Standing Where The Plaintiffs Complaint

Does Not Challenge The Legality Of The

Particular Action Or Conduct Alleged To

Have Caused The Plaintiffs Asserted Injury.

Even if naked but-for causation were sufficient to

demonstrate traceability, the Federal Circuit further

erred by holding that a _ declaratory-judgment

plaintiff has standing where the plaintiffs complaint

does not challenge the legality of the particular

action or conduct alleged to be responsible for the

plaintiffs asserted injury. Indeed, this Court

repeatedly has held that Article III standing requires

the plaintiffs suit to present precisely such a

challenge. See, e.g., Friends of the Earth, Inc. v.

Laidlaw Envtl. Servs. (TOC), Inc., 528 U.S. 167, 180

(2000) (“[T]lo satisfy Article III's standing

requirements, a plaintiff must show [that its] injury

is fairly traceable to the challenged action of the

defendant.”) (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) (“[T]here must be causation—a fairly

traceable connection between the plaintiffs injury

and the complained-of conduct of the defendant.”)

(emphasis added); Allen v. Wright, 468 U.S. 737, 751

(1984) (“A plaintiff must allege personal injury fairly

traceable to the defendant's allegedly unlawful

conduct ....”) (emphasis added); Gladstone, Realtors

v. Village of Bellwood, 441 U.S. 91, 99 (1979)

(plaintiff must “show that he personally has suffcred

some actual or threatened injury as a result of the

putatively illegal conduct of the defendant’)

(emphasis added).

The requirement that standing requires the

plaintiff to trace its injury to conduct actually

challenged in the litigation makes perfect sense. If

the Constitution permitted would-be plaintiffs to

obtain a legal ruling by suing a defendant whose

conduct has allegedly made them worse off —

regardless of whether that conduct is the subject of

the ruling sought or even alleged to be unlawful —

then the federal courts effectively would possess

general jurisdiction to issue advisory opinions that

do not address concrete legal disputes between the

plaintiff and defendant, and that are not even

predicated on allegations of legal wrong.

That, however, is precisely what the Federal

Circuit has permitted in this case. In holding that

Caraco has standing to pursue a_ declaratory

judgment that its proposed generic EO products

would not infringe the ‘941 patent, the Federal

Circuit reasoned that “Forest’s listing of the ‘941

patent (the patent-in-suit) in the Orange-Book

creates an independent barrier to the drug market

that deprives Caraco of an economic opportunity to

compete.” Pet. App. 27a; see also id. 26a (asserting

that “Caraco’s injury is traceable to Forest” because

“if Forest had not listed its ... patents in the FDA’s

Orange Book..., then [the statute] would not

independently delay Caraco’s ANDA from being

approved”) (capitalization omitted).

But Caraco’s lawsuit does not complain about

Forest’s decision to list the ‘941 patent in the Orange

Book at all — much less seek a declaratory judgment

that Forest’s decision to list the ‘941 patent in the

Orange Book was. unlawful. Instead, as the

appellate court recognized, Caraco’s suit against

Forest merely seeks a declaratory judgment that its

proposed generic EO products would not infringe the

‘941 patent. if those products were manufactured or

marketed. Jd. 17a (“Caraco filed a separate action

under the Declaratory Judgment Act, 28 U.S.C.

§§ 2201, 2202, and the Hatch-Waxman [Act], 21

U.S.C. § 355G)(5)(C), seeking a declaratory judgment

that the drug described in its ANDA does not

infringe Forest's ‘941 patent.”); id. 28a n.10 (“Caraco

has not sought a judgment of invalidity in this

case.”).

However, the question of whether Caraco’s EO

product infringes the ‘941 patent — the only issue as

to which Caraco seeks a federal court determination

— is purely hypothetical in this case because Forest

has validly and enforceably promised never to assert

the ‘941 patent against that product. And the

conduct to which Caraco traces its asserted Article

III injury-in-fact, is not, and cannot be, the subject of

a legal claim in any event. Under the Hatch-

Waxman Act, brand manufacturers must submit for

Orange-Book listing “any patent which claims the

drug for which the {brand manufacturer sought FDA

approvai] and with respect to which a claim of patent

infringement could reasonably be asserted if a

person 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 generic

product would not infringe a listed patent (as

Caraco’s product allegedly would not in this case),

the brand-name drug’s manufacturer properly may

list that patent in the Orange Book so long as the

patent covers (or “claims”) the brand-name drug and

its owner reasonably could assert infringement

claims against some other unlicensed’ generic

applicant. Indeed, the law requires the brand

manufacturer to do so.

The distinction between claims of _ non-

infringement, on one hand, and claims that a beang

manufacturer improperly listed a given patent in tay,

Orange Book, on the other, is particularly sharp in

this case. The ‘941 patent claims a narrowly defined

particle size of EO, which is the active ingredient in

Forest’s brand-name product (Lexapro®). Wholly

apart from the question presented by Caraco’s

declaratory judgment action — t.e., whether Caraco’s

proposed generic product does or does not contain KO

particles of the size covered by the ‘941 patent — no

one has ever suggested that Lexapro® does nec?

contain EO particles of the size claimed by the ‘941

patent or that Forest could not reasonably assert

that patent against an unlicensed applicant whose

proposed generic product does contain EO particles

of the size claimed in the ‘941 patent.

Regardless of whether Caraco’s injury somehow

can be traced the Forest’s patent-listing decision —

and as set forth above, that is far from clear —

Forest's legitimate decisio . to list the ‘941 patent in

the Orange Book is not itself “the challenged action,”

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 Article

III standing to pursue this case.

To be sure, nothing would preclude the federal

courts from exercising jurisdiction over this action if

Caraco actually were challenging Forest’s patent-

listing decision. Indeed, numerous courts have

recognized that unlawful patent listings can give rise

to liability under the Sherman Act, and thus have

authorized generic applicants to bring lawsuits

asserting such claims in federal court. See, e.g.,

Xechem, Inc. v. Bristol-Myers Squibb Co., 372 F.3d

899, 901 (7th Cir. 2004) (recognizing an antitrust

cause of action for sham Orange Book listings);

aatPharma 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). Nor

would anything preclude Caraco from bringing a

“civil action for patent certainty” under 21 U.S.C.

§ 355Gg)(5)(B)Gv) if it genuinely faced patent

uncertainty. But this is not such a case; Caraco

seeks only a declaration of non-infringement, and

that claim does not remotely depend on whether

Forest’s Orange Book listing was proper in th@ first

instance.

The Federal Circuit thus erred in holding that the

federal courts have jurisdiction over declaratory

judgment actions like Caraco’s, and this Court

should grant the writ.

CONCLUSION

For the foregoing reasons, the petition should be

granted and the Federal Circuit’s judgment reversed.