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

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## Record

- **Collection:** Supreme Court brief
- **Document type:** Opposition Brief
- **Published:** January 1, 2008

## Text

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

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Source: Frix Law Library, https://www.frixlaw.com/law-library/documents/brief%3Amicro_IA40386020_0797%3A2. Public record. Not legal advice.