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

Supreme Court, U.S.

FILED

a \ | 0 JAN § - 2009

No. 08-624 OFFICE OF THE CLERK

Hn the Supreme Court of the Anited States

FOREST LABORATORIES, INC., FOREST LABORATORIES

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

Uv.

CARACO PHARMACEUTICAL LABORATORIES, LTD.,

RESPONDENT

ON PETITION FOR A WRIT OF CERTIORARI

TO THE UNITED STATES COURT OF APPEALS

FOR THE FEDERAL CIRCUIT

BRIEF FOR RESPONDENT IN OPPOSITION

JAMES F. HURST STEFFEN N. JOHNSON*

DEREK J. SARAFA Winston & Strawn LLP

IMRON T. ALY 1700 K Street, N.W.

SAMUEL S. PARK Washington, D.C. 20006

WILLIAM P. FERRANTI (202) 282-5000

Winston & Strawn LLP

35 W. Wacker Drive

Chicago, IL 60601

(312) 558-5800

*Counsel of Record

Counsel for Respondent

LSP Ten HCA RES STMT ER REIT SEMI SRG AI POT IRATE i ER

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

QUESTION PRESENTED

The Hatch-Waxman Act provides that any generic

drug manufacturer that has filed an abbreviated new

drug application with the FDA, and wishes to estab-

lish that its product does not infringe any Orange

Book-listed j;atent of the name-brand drug, may

bring a declaratory judgment action for that purpose.

The Act vests the federal courts with subject matter

jurisdiction over such actions “to the extent consis-

tent with the Constitution.” 31 U.S.C. § 271(e)(5).

Within that framework, the question presented is:

Whether a name-brand drug manufacturer’s uni-

lateral “covenant not to sue” for infringement of an

Orange Book-listed patent deprives the federal courts

of Article III jurisdiction to hear a generic drug

manufacturers challenge to that patent, where

(1) the covenant not to sue does not concede that the

generic product does not infringe the patent, and

(2) the generic drug manufacturer is barred from en-

tering the market and selling its product absent a ju-

dicial ruling on non-infringement.

il

CORPORATE DISCLOSURE STATEMENT

Pursuant to Rule 29.6, respondent Caraco Phar-

maceutical Laboratories, Ltd. states that it is a sub-

sidiary of Sun Pharmaceutical Industries Ltd., which

is the only publicly held company owning 10% or

more of Caraco’s stock.

TABLE OF CONTENTS

Page

Ee IRIN BRN I cv ccvstsnscvncdececsenvarseveccescevsavenes 1

CORPORATE DISCLOSURE STATEMENT ............. il

TABLE OF AUTHORITIBG ......0csccsccccccscssecesecccoeseveses Vv

BRIEF FOR RESPONDENT IN

aes ctilenshsayenieens 1

a Ld aeiaeungeeeneesanonyees 2

A. The Hatch-Waxman statutory

I cae occtcheanea coceed eds eesaene Gieiesaabecceesesenaces 2

1. Abbreviated new drug

ao, anid ues ccnconaesntoenss 2

2. The “civil action to obtain

SOE COTCMIIIY ocescecncasicesscessnsccssceevessece 5

ee Ft) ee aa eehaneaiock erarer % 6

OR er 7

D. The district court’s decision ..................06..00008 8

E. The court of appeals’ decision ......................... 9

REASONS FOR DENYING THE PETITION........... 12

I. The Petition Provides No Basis For

Reviewing The “Legally Protected

Interest” Holding Of The Decision Below........... 14

A. Forest’s assertion that the decision

below rewrote the “civil action to

obtain patent certainty”

mischaracterizes the Hatch-Waxman

Becta cence ee on a

B. Petitioners’ policy-based concerns are

ee ee eye Seen x

aeons 18

iV

C. The decision below does not conflict

with this Court’s decisions, and is

compelled by MedImmune.i ...............060..0000005 22

D. The Federal Circuit’s post-

MedImmune standing cases are not

I aati aireo ska cettuty a eeras an eciclensostanssonrvvens 23

II. The Petition Provides No Basis For

Reviewing The Court Of Appeals’

Holding That Caraco’s Injury Is “Fairly

Pe | ihe DEIR 27

A. Forest’s assertion that listing its

patents in the Orange Book was

“mandatory” mischaracterizes the

PEGE We GREE BRIN, 9. oiccesicceeiiciesecseseesenitscseveoes: 27

B. Caraco’s injury is not limited to, and

does not depend upon, the first filer’s

180-day exclusivity period. .......................6.4. 31

CONCLUSION ................. ena gata ath edirstatna lengaesies ate 33

Vv

TABLE OF AUTHORITIES

Page(s)

CASES

Alphapharm Pty Ltd. v. Thompson,

Soe ©. pee. 24 1 (D.D.C. 2004)................cccsecsese .. 28

Bennett v. Spear,

I ic cavuesnevennsoveeseaccencveveaes 32-33

Bronson v. Swensen,

500 F.3d 1099 (10th Cir. 2007)............................. 29

Duke Power Co. v. Carolina Envt7 Study

Group, Inc.,

6 Ee 6, s), ussnsniiuniteiaae 30

Eli Lilly & Co. v. Medtronic, Inc.,

Se 3, 16

Focus on the Family v. Pinellas Suncoast

Transit Auth.,

344 F.3d 1263 (11th Cir. 2003)...000 ee BS

Forest Labs., Inc. v. Iuax Pharm., Inc..,

501 F.3d 1263 (Ped. Cir. 2007) .0000000 0. 6-7, 30

Fulani v. Brady,

935 F.2d 1324 (D.C. Cir. 1991)............. 29-30, 32-33

Fulani v. League of Women Voters,

882 F.2d 621 (2d Cir. 1989)... cece cece 32

Gen-Probe Inc. v. Vysis, Inc.,

359 F.3d 1376 (Fed. Cir. 2004) ...00000000.0.00c cece. 22

V1

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

540 F.3d 1353 (Fed. Cir. 2008)............ 15, 17, 25-26

Khodara Envt'l, Inc. v. Blakey,

BIG F.OG 167 GAG Cap. 2004) ..........cccccccccccccsecccsceceee 32

Marbury v. Madison,

Ores Oe CED 2 f CIBOS) 20. 0.ccrccccccscsesscccecesevess 22

Massachusetts v. EPA,

549 US. 497 (2007)...... a is ice 14

MedImmune, Inc. v. Genetech, Inc.,

Bap BG S| 1, 8-9, 14, 22-24

Minnesota Mining & Mfg. Co. v.

Barr Labs., Inc.,

a Si ER |) 26

Mova Pharm. Corp. v. Shalala,

140 F.3d 1060 (D.C. Cir. 1998).....0000...00.c eee. 19-20

Northeastern Fla. Chapter, Assoc. Gen.

Contractors of Am. v. Jacksonville,

508 U.S. 656 (1993)....................... an AAR 14

Nova Health Sys. v. Gandy,

416 F.3d 1149 (10th Cir. 2005)....................00.cceees 33

Prasco, LLC v. Medicis Pharm. Corp..,

eae oe hoe cree, Car. ZO08)............................. 39

Teva Pharm. U.S.A., Inc. v. Novartis Pharm.,

482 F.3d 1330 (Fed. Cir. 2007)....... 5, 8-9, 16-17, 19

Teva Pharm. USA, Inc., v. Pfizer, Inc..,

395 F.aa 1424 (ed. Cir. 2005).............. Can RE AONE 4

Vil

Teva Pharm. USA, Inc. v. Pfizer Inc.,

405 F.3d 990 (ed. Cir. 2005)

STATUTES

Drug Price Competition and Patent Term

Restoration Act of 1984, 21 U.S.C. § 355,

35 U.S.C. §§ 156, 271

WE TI GROIN) inca coccsececsscssecrcecsdvtccevcoceo 3, 28

21 U.S.C. § 355 (c)(2)

21 U.S.C. § 355(j)(2)(A)

21 U.S.C. § 355(j)(2)(A)(vii) I-IV)

21 U.S.C. § 355G)(5)(B)Gii)

21 U.S.C. § 355G)(5)(B)(iv)............6. see tet EN We oar 4, 20

21 U.S.C. § 355G)(5)(B) Gv) dD (2000) 13, 16, 19

21 U.S.C. § 355G)(5)(B) Gv) UID (bb)

BE UG. 5 BOG oncssesicncseevescscccesissscreinnen tl, 3G,

21 U.S.C. § 355G)(5)()

21 U.S.C. § 355G)(5)(D)@M(bb)(AA)......... 2. 12

Se RO Bk!) > | ReneS 3,

35 U.S.C. § 271(e)(5)

OTHER AUTHORITIES

149 Cong. Rec. (Nov. 25, 2003)

S. 1, 108th Cong. (2003)

ROBERT L. STERN ET AL., SUPREME COURT

PRACTICE, COCs OU, DD iu xc vscesexickevecsveesescstssvssnsees 23

BRIEF FOR RESPONDENT IN OPPOSITION

This case involves the question whether federal

courts possess jurisdiction under the Hatch-Waxman

Act to resolve a generic drug manufacturer's chal-

lenge to Orange Book-listed patents, where the pat-

entee agrees not to sue for infringement but refuses

to concede that the generic product does not infringe.

Applying settled principles of Article III jurispru-

dence, the court of appeals issued a carefully rea-

soned opinion concluding that respondent Caraco suf-

fered an injury in fact (exclusion from the market for

generic Lexapro®) that is traceable to petitioners’

conduct (listing their patents in the Orange Book)

and redressable by a finding of non-infringement-——

which would accelerate Caraco’s market entry, poten-

tially by several years.

The result below is compelled by this Court’s re-

cent decision in MedIJmmune, Inc. v. Genetech, Inc.,

549 U.S. 118, 128 (2007), which held that a paid-up

patent licensee was injured by having to pay royalties

on a patent—and thus could challenge its validity in

federal court—even though the licensee was subject

to “no risk” of infringement liability. As the court of

appeals recognized, Caraco’s injury is much greater:

it is not merely forced to pay royalties on the sales of

its product; it is forbidden from selling that product

at all, for as long as there is an unresolved dispute

over the underlying patents. But even if the court

below had misapplied Med/mmune (and it did not),

certiorari would not be warranted to address the ap-

plication of a recent precedent of this Court to a par-

ticular case arising on an interlocutory basis in the

unique context of the pre-2003 Hatch-Waxman Act.

Indeed, not one Federal Circuit judge voted to grant

rehearing.

2

Aware that the court below broke no new ground

in terms of standing law, petitioners attempt to por-

tray its decision as having created a new cause of ac-

tion—-one unauthorized by the statute. As explained

below, however, the decision below faithfully imple-

ments the Hatch-Waxman Act—which entitles any

generic manufacturer that files an abbreviated new

drug application to a judicial decision on whether its

product infringes the patents at issue, and which

provides that a ruling in favor of any such generic

manufacturer can trigger the first filer’s 180-day ex-

clusivity period. Review should therefore be denied.

STATEMENT

A. The Hatch-Waxman statutory scheme

This case arises under the Drug Price Competition

and Patent Term Restoration Act of 1984 (“Hatch-

Waxman Act” or “Act”), 21 U.S.C. § 355; 35 U.S.C.

§§ 156, 271, which governs the approval of new and

generic drugs. The Act is designed to “[strikej a bal-

ance between two competing policy interests: (1) in-

ducing pioneering research and development of new

drugs and (2) enabling competitors to bring low-cost,

generic copies of those drugs to market.” Pet. App.

3a.

1. Abbreviated new drug applications

To streamline the approval of generic drugs, the

Act allows drug manufacturers to submit to the Food

and Drug Administration (“FDA”) an abbreviated

new drug application (““ANDA’”), instead of a full new

drug application (“NDA”). 21 U.S.C. § 355G)(2)(A).

The ANDA process allows genenc manufacturers to

rely on safety and efficacy studies previously submit-

ted by name-brand companies in NDAs. The timing

and approval of an ANIA, however, depends largely

3

on the patent protections covering the name-brand

drug. Pet. App. 4a; Eli Lilly & Co. v. Medtronic, Inc.,

496 US. 661, 676 (1990).

When a name-brand drug company files an NDA,

it must identify all non-process patents that protect

the new drug. 21 U.S.C. § 355(b)(1), (c)(2). Exercising

a “ministerial duty” (Pet. 6), the FDA lists these pat-

ents in its book of “Approved Products With Thera-

peutic Equivalence Evaluations’—the “Orange Book.”

In filing its ANDA, a generic manufacturer must in-

clude one of four certifications for each patent listed

in the Orange Book: (J) a statement that the required

information relating to the patent has not been filed

with the FDA; (iI) a statement that the patent has

expired; (IID a statement that the patent will expire

on a particular date; or (IV) a statement that the pat-

ent is invalid or will not be infringed by the manufac-

ture, use, or sale of the proposed generic drug. 21

U.S.C. § 355G)(2)(A)(vii)-IV). These certifications

are known as Paragraph I, II, III, and IV certifica-

tions, respectively.

When, as in this case, an ANDA contains a Para-

graph IV certification challenging an Orange Book-

listed patent, the Act treats the filing of the ANDA as

an act of patent infringement (35 U.S.C. § 271(e)(2)),

and the patentee may sue the ANDA applicant for

infringement. If the patentee does not sue within 45

days, the FDA may approve the ANDA. 21 U.S.C.

§ 355()(5)(B)aii). If the patentee sues, however, the

ANDA is automatically stayed for 30 months or until

a court holds each Listed patent not infringed (or in-

valid), whichever comes first. /bid. “[T]he purpose of

subsection(] (e)(2) ... is to enable the judicial adjudi-

cation upon which the ANDA ... scheme rests.” Eli

Lilly, 496 U.S. at 678.

4

To “incentavize ANDA filers to challenge the valid-

ity of listed patents or design around those patents as

early as possible,” the pre-2003 version of the Act, at

issue here, provides 180 days of market exclusivity

for the generic applicant that is the first to challenge

each Orange Book-listed patent. Pet. App. 6a. This

“first applicant” or “first filer” receives a 180-day mo-

nopoly on the right to market its generic drug, which

is triggered on either the date that it begins such

marketing (the “commercial-marketing trigger”) or

the date of any final court decision finding the chal-

lenged patent invalid or not infringed (the “court-

judgment trigger”}-—whichever comes first. Pet. App.

6a-7a; see generally Teva Pharm. USA, Inc., v. Pfizer,

Inc., 395 F.3d 1324, 1328 (Fed. Cir. 2005).

Subsequent ANDA filers may not receive FDA ap-

proval until the first applicant’s 180-day exclusivity

period has expired. 21 U.S.C. § 355G)(5)(B)(iv). This

creates a potential “bottleneck”: if the first applicant

cannct (or does not) use its exclusivity, the patentee

can leverage the «.nexpired exclusivity to keep other

generics out of the market, sometimes for decades.

For example, if the first applicant unsuccessfully

challenges one of the hsted patents for which it was

the first Paragraph IV filer, other generic applicants

remain barred from entering the market—unless

they can obtain a court decision holding the other

patents not infringed or invalid. Jbid. Patentees

thus have a tremendous incentive “to insulate [their]

patent[s] from any validity challenge” and “from any

judicial determination of thefir] metes and bounds.”

Teva Pharm. USA, Inc. v. Pfizer Inc., 405 F.3d 990,

993 (Fed. Cir. 2005) (Dyk, J., dissenting from denial

of rehearing en banc).

5

Patentees attempt to insulate their drug patents

from challenge in several ways: (1) by opportunisti-

cally suing on only one Orange Book-listed patent

while holding the others in reserve for future ltiga-

tion, eg., Teva Pharm. U.S.A., Inc. v. Novartis

Pharm., 482 F.3d 1330, 1343 (Fed. Cir. 2007); (2) by

settling on advantageous, duopolistic terms with the

first ANDA applicant and refusing to litigate with

later applicants, e.g., Teva, 405 F.3d at 993 (Dyk, J.,

dissenting from rehearing en banc); and—as here—

(3) by suing subsequent ANDA applicants on one

listed patent while covenanting not to sue on the oth-

ers. Each of these actions injures subsequent ANDA

applicants, frustrates “early resolution of patent dis-

putes,” Novartis, 482 F.3d at 1344, and undermines

“Congress’s intent to foster early generic market en-

try,” Teva, 405 F.3d at 995 (Dyk, J., dissenting from

denial of rehearing en banc).

2. The “civil action to obtain patent cer-

tainty”

“[Tjo prevent patentees from ‘gaming’ the Hatch-

Waxman Act,” Congress enacted the “civil action to

obtain patent certainty” (or “CAPC”). Novartis, 482

F.3d at 1342. The CAPC allows any ANDA applicant

to bring a declaratory judgment suit challenging any

Orange Book-listed patent. 21 U.S.C. § 355G)(5)(C).

As Congress recognized:

[When] the brand drug company [attempts] . . . to

delay a final court decision that could trigger [the

first filer’s exclusivity]... generic applicants must

be able to seek a resolution of disputes involving

all patents listed in the Orange Book ... because

the statutory scheme of the Hatch-Waxman Act

relies on early resolution of patent disputes

6

149 Cong. Rec. $15885 (Nov. 25, 2003) (Sen. Ken-

nedy).

Such a “declaratory action is the ideal method to

police [patentees’] strategic manipulation of the

Hatch-Waxman exclusivity provisions” (Teva, 405

F.3d at 995 (Dyk, J., dissenting from denial of rehear-

ing en banc)) and to “facilitate[] the early resolution

of patent disputes between generic and pioneering

drug companies.” Pet. App. 5a. The Act thus extends

federal jurisdiction over these ANDA declaratory

judgment actions to the full extent permitted by the

Constitution. 35 U.S.C. § 271(e)(5).

B. Caraco’s ANDA

Forest holds an FDA-approved NDA for Lexapro®,

which comprises the active ingredient escitalopram

oxalate. Lexapro®, a.profitable anti-depressant, gen-

erates more than $2 billion in annual sales—over half

uf Forest’s gross revenue. Forest currently faces no

generic competition on Lexapro®. Forest Labs., Inc.

v. lvax Pharm., Inc., 501 F.3d 1263 (Fed. Cir. 2007).

Forest’s NDA for Lexapro® listed two patents in

the Orange Book: U.S. Patent Nos. Re. 34,712 (“the

'712 patent”) and 6,916,941 (“the ’941 patent”). The

‘712 patent, which expires in 2012, is directed to

“substantially pure” forms of escitalopram; the 94]

patent, which expires in 2023, is directed to particles

of escitalopram oxalate with an average size of forty

microns. /bid.!

| After the decision below, Forest listed a third patent—U.S

Patent No. Re. 7,420,069. Pet. 12 n.6. On November 26, 2008

Caraco filed a Paragraph IV certification challenging this pat-

ent, which hke the 941 patent expires in 2023. This patent does

not change the yurisdictional analysis For simplicity, therefore

we refer only to the '712 and 941 patents

7

Caraco wishes to market a generic version of

Lexapro® based on particles of less than three mi-

crons. Caraco’s ANDA, filed in 2006, challenged both

of Forest’s Orange Book-listed patents.

C. Ivax’s exclusivity

Ivax Pharmaceuticals, not Caraco, was the first

generic to file Paragraph IV certifications challenging

Forest's ’712 and 941 patents. To block approval of

Ivax’s ANDA, Forest sued Ivax on the ’712 patent

(but not the 941 patent). The Federal Circuit held

that the 712 patent was valid, and that Ivax’s pro-

posed generic drug infringed it. Forest, 501 F.3d at

1272. At that point, Ivax lost its exclusivity on the

"712 patent.

Having failed to obtain a favorable ruling on the

'712 patent, [vax is barred from entering the market

for generic Lexapro® until the ’712 patent expires in

2012 or another applicant defeats that patent. And

because Ivax has a right to 180 days of market exclu-

sivity on the 941 patent (as first filer on that patent

under the pre-2003 provisions at issue here), no other

generic manufacturer can enter the market until 180

days after Ivax—.e., until at least 180 days after the

‘712 patent expires in 2012—even if that manufac-

turer has a non-infringing product.

The Act allows subsequent generic ANDA filers to

clear this “bottleneck” in one of two ways. In the im-

mediate term—i.e., before the ‘712 patent expires in

2012—they must successfully challenge both listed

patents. In the slightly longer term—i.e., after the

‘712 patent expires in 2012—they need only success-

fully challenge the second patent. After (1) both pat-

ents are ruled invalid or not infringed, or (2) the first

patent has expired and the second has been ruled in-

8

valid or not infringed—either of which would trigger

Ivax’s 180-day exclusivity period—Caraco (and possi-

bly other generics) can enter the market for generic

Lexapro®.

Forest therefore has a strong incentive “to do eve-

rything possible to prevent its patents from being put

in play.” Teva, 405 F.3d at 994 (Dyk, J., dissenting

from denial of rehearing en banc). As long as Forest

can prevent the courts from ruling on its patents, it

can bar all generic competition on Lexapro®, possibly

until 2023, but certainly until 2012.

D. The district court’s decision

As with Ivax, Forest sued Caraco on the ’712 pat-

ent—but not the ’941—to block approval of Caraco’s

ANDA while insulating the 941 patent from chal-

lenge. Desiring to clear the “bottleneck,” Caraco filed

a CAPC against Forest, seeking “a declaration that

one or more claims of the 941 patent will not be in-

fringed by [Caraco’s product].” Pet. App. 99a.

Forest moved to dismiss the suit, initially arguing

that there was no jurisdiction because Caraco lacked

a “reasonable apprehension” that it would be sued for

infringement. Following MedJmmune, however, the

Federal Circuit abandoned the “reasonable apprehen-

sion of suit” test in Novartis, 482 F.3d at 1338-1339.

As the court there recognized, the fact that Caraco “is

not legally free to enter the market ... [is} a direct

legal injury (caused by] the actions that [Forest] ha[d]

already tan°n—[Forest’s} listing of [its] patents in the

Orange Book and [Forest’s] suit against [Caraco]

challenging the validity of (Caraco’s] ANDA.” 7d. at

1345. The dispute over the 941 patent thus involves

“a present injury sufficient for a justiciable contro-

versy.” [bid.

9

Fifteen days after Novartis, and in a desperate at-

tempt to avoid a ruling on Caraco’s claim, Forest

granted Caraco a unilateral “covenant not to sue” on

the '941 patent and asserted that this “mooted” the

controversy. Pet. App. 19a. Yet Forest refused to

concede that the '941 patent was not infringed. In-

stead, Forest argued that the court should dismiss

the case because eliminating the threat of infringe-

ment liability relieved Caraco of its only injury. Id.

at 21a.

After twice changing its mind during argument,

the district court dismissed the case without wmtten

opinion. The court did not explain why the continu-

ing controversy over infringement of the 941 patent

(which Forest refused to concede) or the delayed en-

try to market due to that controversy was insufficient

to support standing. It simply applied the discredited

“reasonable apprehension of suit” test, stating:

“There’s a covenant not to sue on the 941 so there’s

. no threat of a lawsuit ... and no controversy.”

Pet. App. 77a-78a. The court of appeals found “no in-

dication in the record that the district court consid-

ered either the Supreme Court's MedIJmmune deci-

sion or [the Federal Circuit's] Novartis decision when

making this ruling.” Jd. at 20a.

E. The court of appeals’ decision

The Federal Circuit reversed. Observing that the

“reasonable-apprehension-of-suit test was overruled

by MedImmune,” the court explained that jurisdiction

no longer turned solely on the risk of an infringement

suit. Pet. App. 22a. Rather, the court was “guided by

the Supreme Court’s three part framework for deter-

mining whether an action presents a justiciable Arti-

cle III controversy,” under which “proving a reason-

10

able apprehension of suit is only one of many ways a

patentee can satisfy the Supreme Court’s more gen-

eral all-the-circumstances test.” Jd. at 22a, 23a.

The court went on to explain that “Caraco’s al-

leged injury-in-fact’—‘being excluded from selling a

non-infringing product’—is “precisely the type of in-

jury that the Declaratory Judgment Act is designed

to remedy.” Pet. App. 24a, 29a. “fA] potential com-

petitor in other fields is legally free to market its

product in the face of an adversely held patent,” the

court explained, whereas “an ANDA filer ... is not

legally free to enter the market {without FDA ap-

proval].” Jd. at 24a. But “fiJf Caraco is correct that

its generic drug does not infringe Forest’s [patents],

then it has a night to enter the generic drug market,

and its exclusion from the generic drug market by

Forest's actions ... is exactly the type of injury-in-

fact that is sufficient to establish Article UI stand-

ing.” Id. at 25a.

Turning to the traceability prong of standing, the

court held that “[i]t is not the Hatch-Waxman Act or

the FDA framework that prevents Caraco’s ANDA

from being approved by the FDA, but rather Forest's

actions.” Pet. App. 26a. Specifically, in “list[ing] its

{Lexapro®] patents in the FDA’s Orange Book,” For-

est “create[d] an independent barrier to the drug

market that deprives Caraco of an economic opportu-

nity to compete”—“even if [Caraco’s product] does not

infringe” the Lexapro® patents. /d. at 26a-27a. Cit-

ing several precedents of this Court, the court found

it “well settled that the creation of such barriers to

compete satisfies the causation requirement of Article

III standing.” Id. at 27a.

11

As to redressability, the court reasoned that “a de-

claratory judgment ... would clear the path to FDA

approval that Forest's actions would otherwise deny

Caraco”’—and thus “eliminate the potential for the

941 patent to exclude Caraco from the drug market.”

Pet. App. 27a-28a. “In claiming that it has been de-

nied the right to sell non-infringing drugs,” Caraco

alleged “the exact type of uncertainty of legal nghts

that the ANDA declaratory judgment action ... was

enacted to prevent.” Jd. at 25a, 29a.

The court further held that the case was ripe. De-

laying Caraco’s suit would “ha[ve] the ‘immediate and

substantial impact’ of forestalling Caraco’s ability to

activate Ivax’s exclusivity penod through the court-

judgment trigger’—delaying Caraco’s market entry

“until at least 181 days after the 712 patent expires

in 2012,” if not “indefinitely,” and generating “lost

profits.” Pet. App. 26a, 32a-34a.

As to mootness, the court acknowledged that “[i]f

a threat of suit was the only action allegedly taken by

Forest that effectively excluded Caraco from the

marketplace, the covenant not to sue would moot Ca-

raco’s case.” Pet. App. 34a (emphasis added). But

“{a] controversy also exists because Forest’s actions

effectively prevent the FDA from approving Caraco’s

ANDA,.” and “the controversy can only be resolved by

a judgment that determines whether Forest’s °941

patent is infringed.” Jd. at 37a (emphasis added).

Thus, “Forest's covenant not to sue does not eliminate

the controversy.” Ibid.

Judge Friedinan dissented. In his view, the possi-

bility that a first ANDA filer “might not market its

product upon either the expiration of the thirty

month stay period or of the patents” is too “uncertain”

12

to support a declaratory judgment action. Pet. App.

39a. He did not dispute, however, that being kept out

of the market injures Caraco, that Caraco’s injury is

traceable to Forest, or that even if Ivax went to mar-

ket in 2012, a judgment invalidating the ’712 and

941 patents prior to that date would enable Caraco to

enter the market earlier (potentially by years) than it

otherwise could. Nor did the dissent take issue with

the legal standards applied by- the majority. Jd. at

40a. He simply believed that Caraco’s only injury de-

pended on whether Ivax delayed entering the market

in 2012, and that this injury was not ripe.”

REASONS FOR DENYING THE PETITION

Petitioners concede that “the CAPC action should

be interpreted as broadly as possible consistent with

the bounds of Article III.” Pet. 22. Not surprisingly,

they do not suggest that Caraco’s exclusion from the

market is an insufficient injury to support standing.

Nor do they dispute that Forest’s listing of its patents

in the Orange Book is one significant “but for” cause

of Caraco’s delayed market entry, or that a ruling in

Caraco’s favor would redress that injury. In short,

there is no dispute over the basic principles of Article

III jurisdiction that govern this dispute -or even, for

the most part, over how they apply.

Rather, the petition rests on two statutory argu-

ments. First, noting that “an injury must be action-

2 Judge Friedman also believed that, even under the pre-2003

Act, a first ANDA filer can “lose its right to exclusivity” uf it “un-

reasonably delays” marketing its product. But as the court of

appeals recognized (Pet. App. 32a), since Ivax filed its ANDA

before Congress passed the “failure to market provision” (21

USC. § 855g)6)(D)G)d)bb)(AA)), that provision does not goy-

ern Ivax’s exclusivity.

13

able” to support standing, petitioners say the court

below “recast the familiar cause of action for patent

infringement as a cause of action that Congress has

never seen fit to create.” Pet. 15, 17. Second, they

say that Caraco’s injury is not attributable to Forest

because Forest was “compelled” to list its patents in

the Orange Book, and because any 180-day delay is

caused by Ivax’s “first filer” status. Both of these ar-

guments, however, mischaracterize the MHatch-

Waxman Act and the extent of Caraco’s injury.

As explained below, the Act grants not only the

first ANDA filer, but any ANDA filer, the right to a

decision on whether its product infringes any listed

patents; moreover, a ruling in favor of any such

ANDA filer can trigger the first filer’s 180-day exclu-

sivity period. 21 U.S.C. § 355G)(5)(B)Gv)dD (2000).

Thus, there is no basis to petitioners’ suggestion that

the court below recognized a cause of action not au-

thonzed by Congress.

Moreover, listing its patents in the Orange Book

was “mandatory” only insofar as Forest wished to re-

ceive the benefit of a monopoly protected by the Act’s

stringent patent enforcement system—a benefit that

depends on the validity and lawful scope of those pat-

ents. And quite apart from any delay attributable to

Ivax’s 180-day exclusivity period, Forest’s listing of

its patents independently causes Caraco to experience

market delay—potentially several years’ worth of de-

lay—that more than suffices to support standing.

Beneath petitioners’ mischaracterizations of the

Act, all that remains is their quarrel with the court of

appeals’ carefully-reasoned application of settled ju-

risdictional principles to a particular Hatch-Waxman

dispute. But the decision below is compelled by this

14

Court’s decision just two Terms ago in MedImmune,

which held that declaratory relief remains available

even absent risk of infringement lability, provided

there remains a substantial controversy between the

parties—which exists here on account of Forest’s re-

fusal to concede non-infringement. And even if the

court below had misapplied MedIJmmune, there would

be no need for the Court to take up the general prin-

ciples that govern standing in patent cases for the

second time in as many years-—-particularly in this

case, which is a relic of the pre-2003 statutory re-

gime. Certiorari should therefore be denied.

I. The Petition Provides No Basis For Review-

ing The “Legally Protected Interest” Holding

Of The Decision Below.

Forest acknowledges (as it must) Congress's power

to define what constitutes a “legally protected inter-

est.” Pet. 17.. As this Court has observed, “Congress

has the power to define injuries and articulate chains

of causation that will give rise to a case or contro-

versy.” Massachusetts v. EPA, 549 U.S. 497, 516

(2007). Moreover, Forest does not dispute that being

kept out of the market is a cognizable Article III in-

jury. Nor could it. Numerous decisions of this Court,

recognized by the court of appeals (Pet. App. 27a),

confirm that “a barrier that makes it more difficult”

to “compete on an equal footing” can support stand-

ing. E.g., Northeastern Fla. Chapter, Assoc. Gen.

Contractors of Am. v. Jacksonville, 508 U.S. 656, 666

(1993).

Unable to quarrel with the general principles that

govern whether Caraco has suffered an injury, Forest

attempts to justify review by maintaining that Hatch-

Waxman offers no protection for Caraco’s interest in

15

entering the market with a non-infringing product.

According to Forest, the Federal Circuit “recast the

familiar cause of action for patent infringement” as

one “premised on a nonexistent right to seek review

of any action by a pioneer drug company that con-

tributed to preventing a generic company from mar-

keting its drug.” Pet. 15, 20.

Even if this were so, it would raise only a question

of statutory interpretation, not standing, and Forest

has not sought review of the Federal Circuit’s reading

of the Act. See Pet. i (raising only jurisdictional is-

sues). Any complaint that the court below misread

the Act is not presented by the petition and cannot

support certiorari. As shown below, however, the pe-

tition badly mischaracterizes both the Act and the

reach of the decision below. Certiorari is therefore

unwarranted for that reason as well.

A. Forest’s assertion that the decision below

rewrote the “civil action to obtain patent

certainty” mischaracterizes the Hatch-

Waxman Act.

To read the petition, one would think the Hatch-

Waxman Act granted only first ANDA filers the right

to challenge name-brand drug companies’ patents.

Yet Forest fails to provide any reason to question the

Federal Circuit’s conclusion that any generic’s inabil-

ity to market its product due to a name-brand com-

pany’s patent listings is an injury that the CAPC is

designed to address.

Indeed, with one exception discussed below (the

Federal Circuit's recent Janssen decision, which For-

est misinterprets), Forest cites not a single authority

to support its assertion that subsequent ANDA apph-

cants have no cognizable interest in obtaining rulings

16

that their products do not infringe—and thus in get-

ting their ANDAs approved. See Pet. 20-25. Instead,

Forest simply assumes that avoiding liability for in-

fringement is Caraco’s only “legally protected inter-

est,” and proceeds from that assumption to lambaste

the jurisdictional analysis of the court below. But

Forest's assumption is wrong— and once that becomes

clear, nothing remains of its suggestion that the court

below departed from “bedrock” principles of Article

Ill standing.

When a generic drug maker’s ANDA contains a

Paragraph IV certification challenging the infringe-

ment (or validity) of an Orange Book-listed patent,

the Act treats the very filing of the ANDA as an act of

patent infringement. 35 U.S.C. § 271(e)(2). NDA fil-

ers such as Forest are well served by this provision—

which this Court has recognized as necessary “to en-

able the judicial adjudication upon which the ANDA

... scheme rests.” Eli Lilly, 496 U.S. at 678.

But to “level the playing field” (Novartis, 482 F.3d

at 1342), the CAPC also permits any ANDA filer—

whether the first or any other -to obtain a decision

on whether each patent at issue is invalid or not. in-

fringed. Similarly, any ANDA filer can set in motion

the 180-day exclusivity period, and speed its FDA ap-

proval, by obtaining a favorable decision on the mer-

its. 21 U.S.C. § 355G)(5)(B)av)dD (2000); 21 U.S.C.

§ 355G)(5)(C); see also id. § 355G)(5)(D)G)()(bb)(AA)

(providing that a successful CAPC by “any other ap-

plicant” can trigger forfeiture of the first filer’s exclu-

sivity). The Act thus grants each ANDA applicant a

statutory nght to a ruling on whether its generic

product infringes valid Orange Book-listed patents.

17

What is more, Congress extended jurisdiction over

such declaratory judgment actions to the full extent

permitted by the Constitution. 31 U.S.C. § 271(e)(5).

Without analysis or citation of authority, Forest de-

clares that “the Federal Circuit erred in converting

that interpretive instruction into an authorization to

create a freestanding cause of action for any injury

experienced by ANDA filers traceable in any respect

to the blocking patent holder.” Pet. 22. But the Fed-

eral Circuit has done no such thing. It has merely

held—in decisions of three different panels—that the

CAPC reaches disputes over infringement that block

an ANDA filer’s ability to reach market with a non-

infringing product. See Pet. App. 25a, 29a; Novartis,

482 F.3d at 1345; Janssen Pharmaceutica, N.V. v.

Apotex, Inc., 540 F.3d 1353, 1360 (Fed. Cir. 2008).

Indeed, even if the question “is whether the civil

action to obtain patent certainty ... creates a private

right of action apart from redressing disputes over

infringement” (Pet. 19), there is a dispute over in-

fringement here. Forest carefully crafted its unilat-

eral “covenant not to sue” to avoid conceding non-

infringement. True, Caraco faces no risk of liabi/ity

for infringement. But as the court below recognizea

(Pet. App. 25a), potential lability is not the only type

of harm that declaratory judgment suits are designed

to prevent (let alone the only type of harm that Arti-

cle II] recognizes). Suits seeking a declaration that

one’s product does not infringe a competitor's patents

also prevent harm in the form of delayed market en-

try, and such an injury undisputedly satisfies Article

III. Indeed, all that Forest has done is promise not to

sue Caraco for damages that Caraco cannot inflict: If

Caraco may not pursue its claim, then it cannot bring

its product to market regardless of the covenant; and

18

if Caraco prevails, its product is non-infringing and

Forest could not sue it regardless of the covenant.’

In sum, even if the court below had misread the

scope of the CAPC, that mistake would be a matter of

statutory interpretation on which Forest has not

sought review; it would not amount to a conflict in

the law of standing, let alone a “judicial legerdemain”

regarding any “bedrock constitutional requirement.”

Pet. 15. But in any event, the court properly inter-

preted the scope of the CAPC. Accordingly, review

should be denied.

B. Petitioners’ policy-based concerns are un-

founded.

Once it becomes clear that Forest’s objection to the

decision below is foreclosed by the Act itself, nothing

remains of the parade of policy horribles offered to

support certioran.

1. For example, Forest and its amici assert that

the decision below upsets the Act’s “careful balance”

between innovation and competition. Pet. 31-35; Ivax

Br. 3-5; Pfizer Br. 19-21; WLF Br. 21-22. But since

Congress provided that any ANDA filer could bring a

declaratory judgment action to challenge the listed

patents (and, if successful, trigger the 180-day exclu-

sivity period), the ruling at issue in fact implements

that balance.

Indeed, an ANDA filer’s CAPC its especially ap-

propriate where, as here, the first filer has unsuccess-

fully challenged one of the listed patents. Able to

3 The 941 patent claims escitalopram particles with an average

size of forty microns—versus three microns for Caracos product

Forest is playing games with the Hatch-Waxman framework

because it cannot establish infringement

19

avoid subsequent ANDA filers’ challenges, the pat-

entee in such cases—with a victory over the first filer

on a single patent—could prevent all other generics

from challenging the listed patents (and entering the

market) simply by granting covenants not to sue.

Such gaming of the system would gut Congress’s pro-

vision for multiple challenges to the listed patents—

the statutory right to obtain a decision even when the

first filer’s suit fails. 21 U.S.C. § 355G)(5)(B)av) dq)

(2000); 21 U.S.C. § 355G)(5)(C). It would also be the

antithesis of “enabl{ing] competitors to bring cheaper,

generic ... drugs to market as quickly as possible’—

the “central purpose of the Hatch-Waxman Act.”

Novartis, 482 F.3d at 1344.4

After all, first filers’ Paragraph IV certifications

need not be correct, just complete. 21 U.S.C. § 355q)-

(5)(B)tiv) dD (bb); Pet. App. 6a. Thus, as the D.C. Cir-

cuit observed in Mova Pharmaceutical Corp. v. Sha-

lala, 140 F.3d 1060 (D.C. Cir. 1998), allowing subse-

quent ANDA filers to use a declaratory judgment ac-

tion to reach market is not only “textually persua-

sive,” but also “a particularly appropriate solution in

cases in which the second applicant has done a better

job of designing around the pioneer drug manufac-

turer’s patent than the first did: in such cases, the

second applicant should find it (relatively) easy to

win a declaratory judgment action against the pat-

¢ Petitioners disclaim “gaming” the Act, noting that “avoiding

the costs, uncertainty, and disruption of litigation are legitimate

ends in themselves.” Pet. 30. Indeed they are. But to quote

petitioners, “no tears should be shed for [Forest].” /d. at 33. If

not being “conscripted” to participate in “needless litigation”

were Forest's objective (tbid.), it could easily be accomplished by

suipulating to non-infringement and the entry of a consent de-

cree. See Pet. App. 28an.11

20

ent-holder. [This] reading thus rewards those appli-

cants (and only those applicants) who have built a

better mousetrap.” Id. at 1073 (emphasis added). Ca

raco alleges that it has built a better mousetrap.

Forest has no right to shield itself with Ivax’s fail-

ure.®

2. Forest and its amici nonetheless complain that

it is unfair for subsequent ANDA filers to be able to

run off the first filer’s 180-day exclusivity period be-

fore that first filer—whose own challenge to the earli-

est-expiring patent failed—can go to market. Pet. 33-

34; Ivax Br. 3-4; Pfizer Br. 19. This argument, how-

ever, is not an argument for certiorari, but rather a

policy objection to Congress’s decision to permit any

ANDA filer to trigger the first filer’s exclusivity.

Moreover, petitioners’ argument is of diminishing

importance in light of the 2003 amendments to the

Act. Under the pre-2003 provisions at issue here, the

180-day exclusivity period may be triggered on a pat-

ent-by-patent basis; but under the post-2003 law, the

180-day period applies on a product-by-product basis,

such that no ANDA filer may qualify for exclusivity

by challenging patents added to the Orange Book af-

ter the first ANDA filing. 21 U.S.C. § 355G)(5)(B)Qv).

Thus, fewer and fewer cases will involve situations in

which a first filer loses its exclusivity period on one

patent, yet retains another period (based on another

patent) that is put at risk in the htigation necessary

for subsequent ANDA filers to reach market. For ex-

a

& Forest asserts that. Mova identified two distinct problems for

ANDA applicants trying to reach market: the reasonable-

apprehension-of-suit test and the case-or-controversy requirc-

ment. Pet. 4. But in fact, the problems were one and the same:

the case or controversy requirement as then applied by the Fed-

eral Circuut. See 140 F.3d at 1073

21

ample, Forest listed its 941 patent after Ivax’s ANDA

was filed. If the new law applied, Ivax’s exclusivity

would have depended entirely on its challenge to the

’°712 patent: Ivax would have forfeited that exclusiv-

ity period when it failed to defeat the ’712 patent, and

Ivax would therefore have nothing at stake in this

litigation. See id. § 355()(5)(D). This case is a relic

of the pre-2003 regime.

3. Petitioners say “the incentives for first filers

have to be set ex ante behind a veil of ignorance,” and

they accuse the court below of allowing “other gener-

ics to take their own separate shots at piercing [For-

est’s] patent” based on “ex post knowledge that Ivax’s

patent litigation against Forest had failed.” Pet. 32.

But while the Act’s incentive scheme must be ana-

lyzed apart from the outcome of particular cases, it is

Congress that authorized all ANDA filers (not just

first filers) to bring CAPCs; it is Congress that pro-

vided federal jurisdiction to hear such suits to the ex-

tent permitted by the Constitution; and it is Congress

that provided for any ANDA filer’s successful declara-

tory judgment suit to trigger the 180-day exclusivity

period. Thus, insofar as the court below permitted

“other generics to take their own separate shots at

piercing [Forest’s] patent,” it was carrying out Con-

gress’s intent. Forest can suggest otherwise only by

ignoring the Act’s text.

4 Amicus Pfizer (Br. 8-10) wrongly equates the

decision below with a rejected Senate bill that would

have created “automatic jurisdiction” by providing

that the filing of a Paragraph IV certification and the

failure of the NDA holder to sue for infringement

would “establish an actual controversy between the

applicant and the patent owner sufficient to confer

subject matter jurisdiction in the courts.” S. 1, 108th

22

Cong. § 702(c) (2003). But as the court below recog-

nized, the enacted law granted jurisdiction “to the ex-

tent consistent with the Constitution” (35 U.S.C.

§ 271(e)(5)), and that language expresses Congress’s

intent while acknowledging that “it is ultimately the

province and duty of the judicial department, not

Congress, to discern the hmits of Article III.” Pet.

App. 3la n.13 (citing Marbury v. Madison, 5 U.S. (1

Cranch) 137 (1803)). The court below thus considered

the specific facts here under MedImmune’s “all-the-

circumstances test.” Jd. at 23a. Its analysis was the

opposite of a formulaic, “automatic jurisdiction” ap-

proach.

C. The decision below does not conflict with

this Court’s decisions, and is compelled

by MedImmune.

Forest also says the court below “ran roughshod

over decisions of this Court.” Pet. 15. But apart from

asserting that the court contravened Lujan by misin-

terpreting the scope of the CAPC, Forest makes no

attempt to demonstrate a conflict with this Court’s

decisions. More importantly, Forest offers no con-

vincing argument that this Court’s decision just two

Terms ago in MedIlmmune does not compel the out-

come below.

The plaintiff in Med/mmune was a paid-up patent

licensee who sought a declaratory judgment that the

underlying patent was not infringed by the licensee’s

product. A fully-paid patent license is no different

from a covenant not to sue—indeed, a fully-paid h-

cense is “an enforceable covenant not to sue.” Gen-

Probe Inc. v. Vysis, Inc., 359 F.3d 1376, 1381 (Fed.

Cir. 2004). Moreover, the licensee in MedIJmmune,

like Caraco here, faced “no risk” of infringement h-

23

ability. 549 U.S. at 128. Yet the Court found a con-

troversy sufficient to support jurisdiction because the

plaintiff had to pay royalties on a patent that it alleg-

edly did not infringe. Jd. at 128-130. Here, the injury

is greater: Caraco is not merely required to pay roy-

alties on the sale of generic Lexapro®; it is forbidden

from selling generic Lexapro® at all, so long as there

remains an unresolved dispute over infringement of

the 941 patent.

Petitioners dismiss MedIJmmune by arguing that it

“did not involve Hatch-Waxman” and “held only that

a patent licensee could pay royalties under protest

without mooting its .. . declaratory judgment action.”

Pet. 2, 3; accord WLF Br. 17. But in fact, the govern-

ing principles and the injury at issue—lost revenue

due to a patent that the declaratory judgment plain-

tiff alleges is not infringed—are the same. If a paid-

up license (an “enforceable covenant not to sue”) did

not destroy jurisdiction in MedIJmmune—where the

plaintiff was free to sell its product—then Forest's

covenant does not destroy jurisdiction a fortiort.

D. The Federal Circuit’s post-MedImmune

standing cases are not in conflict.

Lacking a serious argument that the decision be-

low conflicts with the decisions of this Court, Forest

and its amici attempt to find disarray in the Federal

Circuit’s standing decisions. Pet. 25; Pfizer Br. 14-19.

As shown below, however, the Federal Circuit’s post-

MedImmune cases are consistent, and there is cer-

tainly no need for a second review of its standing doc-

trine in as many years. ROBERT L. STERN FT AL., SU-

PREME COURT PRACTICE § 6.37 at 459 (8th ed. 2002)

(“The Court is too busy to supervise every application

of its precedents to particular facts and circum-

24

stances, even if a given application is arguably

wrong, “particularly if it has recently addressed an

issue and the lower courts are just beginning to apply

the rule it has declared”).

1. The first note in the “cacophony” of precedent

about which Forest complains is a “line of cases hold-

ing that the granting of a covenant not to sue for in-

fringement moots a declaratory judgment action to

resolve an infringement dispute.” Pet. 21 n.10, 23.

The cases cited, however, either have nothing to do

with Ilatch-Waxman, pre-date MedIJmmune, or both.

Thus, they do not conflict with the decision below.

In an ordinary infringement case—where the only

question is whether the plaintiffs actions expose it to

hability—a covenant not to sue allows the recipient to

enter the marketplace and thereby moots the case.

That is why the covenants in the cases cited by Forest

eliminated jurisdiction—a point the court below rec-

ognized. See Pet. App. 34a-35a.

In the Hatch-Waxman context, by contrast, a cove-

nant not to sue does not eliminate the non-first filer’s

barrier to market entry; it perpetuates that injury by

preventing that generic from obtaining the judgment

of invalidity or non-infringement needed for FDA ap-

proval. Pet. App. 35a-36a. Thus, decisions holding

that a covenant not to sue eliminates jurisdiction in a

typical patent infringement case do not conflict with

the ruling below.

2. Forest also relies on Federal Circuit cases hold-

ing that a plaintiff lacked an interest protected by the

Patent Act. Pet. 23. Here again, however, Forest as-

serts rather than demonstrates that the decision be-

low misinterpreted the scope of the CAPC. As shown

above, Forest is wrong; but even if it were correct,

25

these cases do not remotely establish an intra-circuit

conflict. Rather, they show that the circuit's Luan

case law is of a piece in recognizing that standing

may be “founded upon a viable cause of action”

(tbid.)—and that Forest’s complaint is an (unfounded)

objection to the court’s reading of the CAPC.

3. Finally, Forest asserts that the Federal Circuit

in Janssen “appeared to recognize, in conflict with the

holding here, the absence of a legally cognizable in-

jury.” Pet. 24; accord Pfizer Br. 15-17. But as Forest

acknowledges, Janssen expressly reaffirmed Caraco,

distinguishing it on the ground that the generic

manufacturer there (Apotex) “stipulated that the ear-

hest expiring patent was valid and infnnged.” Pet.

24. As the court there explained:

The key difference between Caraco and this case

is that the harm that gave nse to the junsdiction

over the declaratory judgment claim in Caraco

ceased to exist once Apotex stipulated to the va-

lidity, infringement, and enforceability of the

[first-to-expire] patent. Therefore, unlike Caraca,

Apotex cannot claim that... it was being excluded

from selling a noninfringing product by an invalid

patent—it stipulated ta the validity of the [first-

to-expire] patent. Even if Apotex successfully in-

validates the [later-expiring] patents, it cannot

obtain FDA approval until the expiration of the

[first-to-expire] patent because of its stipulations

with respect to that patent.

540 F.3d at 1361 (emphasis added).

Janssen did not question that the delayed market

entry suffered by Caraco is a cognizable injury, that it

is traceable to Forest, or that it will be redressed if

Caraco prevails. Nor did it hold, as Forest asserts,

26

“that the generic’s declaratory judgment claims with

respect to the latter two patents were moot.” Pet. 24.

It simply held that a generic’s CAPC challenge to one

patent is not ripe while another, admittedly valid and

infringed patent remains in force and independently

precludes market entry. Because Caraco maintains

that each of Forest's Lexapro® patents is invalid or

not infringed, there is no conflict between Janssen

and the decision below. See also Minnesota Mining &

Mfg. Co. v. Barr Labs., Inc., 289 F.3d 775, 780 (Fed.

Cir. 2002) (a patentee’s infringement suit against a

genenic ANDA applicant was justiciable even a/ter

the patentee conceded non-infringement, where the

parties’ disagreement over whether dismissal should

be with prejudice directly affected the timing of the

generic’s market entry).

Forest admits that Caraco’s challenge to Forest's

earliest-expiring patent creates a “significant differ-

ence between Janssen and this case,” yet says this is

irrelevant because the name-brand company there

argued on rehearing that the decision below should

be overruled. Pet. 24-25. Any discomfort that the

name-brand company may have felt about its victory

in Janssen, however, likely stemmed from Janssen’s

consistency with the decision below—such that Apo-

tex may refile its suit when its injury from the later-

expiring patents ripens.

In sum, petitioners fail to support their assertion

that the Federal Circuit is “confused about the pro-

tectable-right requirement of Lujan.” Pet. 25. The

very cases on which they rely demonstrate the court’s

diligence in ensuring that plaintiffs have a protected

legal interest related to the patent at issue.

27

II. The Petition Provides No Basis For Review-

ing The Court Of Appeals’ Holding That Ca-

raco’s Injury Is “Fairly Traceable” To Forest.

Aware that “exclusion from the generic drug mar-

ket . .. is exactly the type of injury-in-fact that is suf-

ficient to establish Article III standing” (Pet. App.

25a), Forest and its amici attempt to justify certiorari

by arguing that the decision below created “tension”

with other lower court rulings in failing to attribute

Caraco’s injury to (1) Forest’s “mandatory compli-

ance” with Hatch-Waxman, and (2) Ivax, the first

filer, whose 180-day exclusivity period must run be-

fore Caraco reaches market. Pet. 16, 26-28; Ivax Br.

5-6, 10.

As shown below, however, the Act requires listing

patents in the Orange Book only as a condition of re-

ceiving statutory benefits that depend on the validity

and scope of those patents. Thus, it is misleading to

portray the listing requirement as “mandatory.” Fur-

thermore, although the scope of Caraco’s injury may

be worsened by Ivax’s 180 days of market exclusivity,

it is not limited to—and does not depend on—the 180-

day delay. If Caraco’s product does not infringe For-

est’s patents, the listing of those patents tndepend-

ently causes market delay—potentially several years’

worth of delay—that itself supports standing.

A. Forest’s assertion that listing its patents

in the Orange Book was “mandatory”

mischaracterizes the Hatch-Waxman Act.

1. Like its first, Forest’s second question pre-

sented—whether causation is satisfied where the in-

jury “traces to a patent holder’s comphance with a

mandatory patent listing obligation” (Pet. i)—

depends on a mischaractenzation of the Act.

28

As Forest well knows from litigation over its own

strategic choice not to list its patents in the Orange

Book, the FDA’s Orange Book-listing responsibilities

are purely “ministerial.” It was Forest that took the

initiative to obtain patent protection for Lexapro®,

and Forest that drafted patents purportedly covering

the market. Forest was thereafter “mandated” to list

those patents in the Orange Book only if it wished to

avail itself of Hatch-Waxman’s mechanism for enforc-

ing its monopoly—a mechanism that provides name-

brand drug manufacturers substantially more protec-

tion than that enjoyed by patentees in any other con-

text. The lawful availability of this statutory benefit

(and of Forest's monopoly), however, depends on the

validity and scope of the underlying patents. See 21

U.S.C. § 355(b)(1). Thus, it is misleading to say that

Caraco’s injury “traces to sovereign legal action,” or

that the decision below conflicts with lower court de-

cisions addressing whether “but-for causation fis] suf-

ficient to establish standing where ... the com-

plained of conduct leads to injury only by virtue of its

combination with other, more dominant causes trace-

able to sovereign acts.” Pet. 16, 26. In sum, Forest

has greatly overstated the sovereign’s role in Orange

Book listings and greatly understated its own.

2. Forest nonetheless attempts to gin up a conflict

to support certiorari. But the two cases on which it

relies (Pet. 26-27) involve highly dissimuar facts, and

neither conflicts with the ruling below.

6 Pet. 6; see Alphapharm Pty Ltd. v. Thompson, 330 F. Supp. 2d

1 (D.D.C. 2004) (discussing Forest's strategic omission of a pat-

ent from its Orange Book-listing, rejecting an ANDA filer’s com-

plaint that the FDA was required to police such listings, and

collecting authorities holding that the FDA has only a “ministe-

rial role” in patent listings)

29

In Bronson v. Swensen, 500 F.3d 1099 (10th Cir.

2007), the plaintiffs attempted to challenge a crimi-

nal ban on polygamy by suing a county clerk for re-

fusing to license a polygamous union. But as Forest

notes (at 26), the plaintiffs there argued that they

would have beer immune from prosecution if the

clerk issued them a marriage license, and the court

rejected their argument because it turned on “collat-

eral benefits” that they hoped to receive if the clerk

acted in the future, rather than any injury the clerk’s

actions had already caused. See 500 F.3d at 1111.

Here, by contrast, Caraco is suing Forest for actions

it has already taken (listing its patents in the Orange

Book), and injury it has already caused (throwing up

a barrier to the market for generic Lexapro®). More-

over, the fact that a ruling for Caraco will have the

incidental effect of triggering Ivax’s 180-day exclusiv-

ity period does not diminish the fact that it will elimi-

nate the barrier to market caused directly by Forest's

patents. Thus, even setting aside the obvious factual

differences between the decisions, Bronson does not

conflict with the decision below.

Forest also asserts a conflict with Fulani v. Brady,

935 F.2d 1324 (D.C. Cir. 1991). There, a candidate

excluded from a presidential debate sued the IRS to

revoke the tax-exempt status of the debate’s sponsor

(who was not before the court), seeking to prevent it

from holding the debate. See Pet. 27. But in denying

standing, the court relied on the “special problems

attendant upon the establishment of standing in ...

tax cases, when a litigant seeks to attack the tax ex-

emption of a third party.” 935 F.2d at 1327 (internal

quotation marks omitted). Such “special problems”

are absent here.

30

Fulani also held that intervening causes broke the

chain connecting the IRS to the plaintiffs injury be-

cause, even if the court had revoked the sponsor’s tax

exemption, other factors still would have excluded the

plaintiff from the debate. See 935 F.2d at 1329-1330.

Here, by contrast, Forest’s patent listing “creates an

independent barrier to the drug market that deprives

Caraco of an economic opportunity to compete,” and

“fijt is well established that the creation of such bar-

riers to compete satisfies the causation requirement.”

Pet. App. 27a (emphasis added).7 Indeed, Fulani cuts

against Forest’s position: the court there refused to

attribute causation to the sovereign when conduct by

others—parties akin to Forest—was the true cause of

injury. 935 F.2d at 1331.

3. At bottom, Forest’s complaint with the Federal

Circuit’s traceability analysis has nothing to do with

the legal standard applied by the decision below—the

“but for” causation standard set forth in Duke Power

Co. v. Carolina Enuvt’l Study Group, Inc., 438 U.S. 59,

74 & n.26 (1978). See Pet. App. 26a. Instead, Forest

is dissatisfied with how the court applied this settled

principle in the Hatch-Waxman Act context. Even if

Forest were correct on the merits, such an argument

would not justify certiorari. But as we have shown,

the court below faithfully apphed this Court’s juris-

prudence.

7 Pfizer argues (at 17-18) that the decision below conflicts with

Prasco, LLC v. Medicis Pharm. Corp., 537 F.3d 1829 (Fed. Cir.

2008). But that argument depends on a flawed analogy between

marking a product to provide statutory notice to potential in-

fringers (which the Prasco plaintuff did not claim “had actually

restrained its right to freely market fits product},” id. at 1339),

and an Orange Book-listing (which immediately “creates an in-

dependent barrier to the drug market,” Pet. App 27a)

3]

B. Caraco’s injury is not limited to, and does

not depend upon, the first filer’s 180-day

exclusivity period.

Forest and amicus Ivax also seek to justify review

by arguing that the decision below created a conflict

concerning the traceability standard in failing to

trace Caraco’s injury to Ivax’s first-filer status, which

they deem an “intervening cause.” Pet. 16, 28; Ivax

Br. 9-16. This argument lacks merit.

1. Although Caraco’s ANDA may not be approved

until Ivax’s exclusivity period has run, that does not

mean the exclusivity period is an intervening cause of

Caraco’s injury. Nor is this action “brought solely to

spou the first filer’s exclusivity,” as Pfizer asserts (at

19). To be sure, Caraco seeks to run off that 180-day

delay, but also to avoid years of delay caused directly

by the listing of Forest’s patents. Whether Caraco is

the first or last ANDA filer, it has a statutory night to

file a CAPC challenging those patents. And a favor-

able ruling on Caraco’s claims will clear both the

(larger) barrier created by the listing of the patents

and the (smaller) barrier created by the 180-day ex-

clusivity period. In Congress's design, triggering the

exclusivity period is simply an incidental effect of a

successful challenge to the listed patents.

Even if the 180-day delay were not attributable to

Forest's Orange Book-listing (which it is), the longer

market delay caused by the listing of the patents is.

For example, if Caraco defeated both the ’712 and

941 patents in 2009, Caraco could enter the market

in just 180 days—avoiding roughly three years of de-

lay caused by the '712 patent, which otherwise would

keep Caraco out of the market until 2012. This is in-

dependently sufficient to support standing.

32

2. Second, Ivax’s argument—which acknowledges

that Forest is a cause of Caraco’s injury, but says

“Ivax’s intervening actions fundamentally sever the

chain of causation’—assumes that a cause must be

the last or proximate cause in the chain of causation

to satisfy the causation requirement. Ivax Br. 5. But

as this Court explained in Bennett v. Spear, 520 U.S.

154 (1997)—a case Forest and Ivax never cite—such

a view “wrongly equates injury ‘fairly traceable’ to

the defendant with injury as to which the defendant’s

actions are the very last step in the chain of causa-

tion.” Jd. at 168-169.

Forest’s actions may not be the last step in the

chain of causation, but they are an independent “but

for” cause of Caraco’s injury—which Forest does not

deny. This is more than sufficient. As then-Judge

Alito once observed, “Article III standing demands a

‘causal relationship,’ but neither the Supreme Court

nor {the Third Circuit] has ever held that but-for cau-

sation is always needed,” particularly “where an ef-

fect is ‘causally over-determined, i.e., where there are

multiple sufficient causes.” Khodara Envt', Inc. v.

Blakey, 376 F.3d 187, 195 (3d Cir. 2004).

3. In any event, the centerpiece of Ivax’s argu-

ment that there is “deep and abiding confusion” in

the circuit courts over the test for traceability (Br. 7,

11-13) is a stale conflict between the D.C. and Second

Circuits over particular facts presented to both courts

some twenty years ago. The D.C. Circuit in Fulani

(discussed above) rejected the Second Circuit's analy-

sis, which had found traceability because “but for” the

IRS’s actions, the plaintiffs exclusion from the debate

ultimately would not have occurred. Fulani v. League

of Women Voters, 882 F.2d 621, 628 (2d Cir. 1989).

The D.C. Circuit concluded that the Second Circuit

33

overlooked intervening causes better viewed as the

true causes of the plaintiffs harm. See 935 F.2d at

1328-1329. But this disagreement is limited to the

cases’ specific facts, and does not cast doubt on the

legal principle applied below. Moreover, both cases

pre-date Bennett, which confirms that a third party

who proximately causes an injury is not the only

party to whom that injury may constitutionally be

traced. 520 U.S. at 168-169.

Nor have the Tenth and Eleventh Circuits

“thrown up their hands” on the issue of traceability.

Ivax Br. 13. Rather, as the cases cited by Ivax con-

firm, those courts have merely explained, correctly,

that the causation requirement for standing is not as

stringent as the concept of proximate cause. Nova

Health Sys. v. Gandy, 416 F.3d 1149, 1156 (10th Cir.

2005); Focus on the Family v. Pinellas Suncoast Tran-

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

In short, consistent with the decision below (Pet.

App. 26a) and the position of both parties in this case

(see Pet. 26), all the circuits recognize that an inde-

pendent “but for” cause suffices to support standing.

Accordingly, there is no conflict warranting certiorari.

CONCLUSION

For the foregoing reasons, the petition for a writ of

certiorari should be denied.

34

Respectfully submitted.

JAMES F. HURST STEFFEN N. JOHNSON*

DEREK J. SARAFA Winston & Strawn LLP

IMRON T. ALY 1700 K Street, N.W.

SAMUELS. PARK Washington, D.C. 20006

WILLIAM P. FERRANTI (202) 282-5000

Winston & Strawn LLP

35 W. Wacker Drive *Counsel of Record

Chicago, IL 60601

(312) 558-5800

Counsel for Respondent

JANUARY 2009