Petition for Writ of Certiorari — Apotex, Inc. v. Janssen Pharmaceutica, N.V. (No. 08-959)

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( Supreme Cott, U.S.

.:-

Novos. O08 959 JAN 27 2009

OFFICE OF THE CLERK

IN THE

Supreme Court of the United States

APOTEX, INC.,

Petitioner,

Vv.

JANSSEN PHARMACEUTICA, N.V.

and JANSSEN, L.P,

Respondents.

On PETITION FOR A WRriT OF CERTIORARI TO THE

UNItrebD States Court OF APPEALS

FOR THE FEDERAL CIRCUIT

PETITION FOR A WRIT OF CERTIORARI

SHASHANK UPADHYE

Apotex, INC.

150 Signet Drive

Weston, Ontario M9L 1T9

CANADA

(416) 401-7701

January 27, 2009 Counsel for Petitioner

220078 g

COUNSFI PRESS

(800) 274-3321 * (800) 359-6859

QUESTION PRESENTED

This is one of many suits brought by generic

pharmaceutical manufacturers seeking a declaratory

judgment that an equivalent generic drug product will not

infringe a patent held by the brand-name manufacturer.

Indeed, petitioner Apotex Inc. has filed numerous such suits,

only to suffer significant injury when they were dismissed

based upon the misapplication of controlling precedent from

this Court. These dismissals continue despite this Court’s

decision in MedImmune, Inc. v. Genentech, Inc., 127 S. Ct.

764 (2007).

The Question Presented is whether such a suit states a

justiciable controversy when, as in this case, the failure to

secure a court judgment prohibits the federal government

from approving the generic equivalent and the prospect of

massive patent liability deters the generic manufacturer from

entering the marketplace.

LIST OF PARTIES

All parties in the proceedings below are listed in the

caption to this Petition.

RULE 29.6 CORPORATE

DISCLOSURE STATEMENT

The parent company of Apotex Inc. is Apotex

Pharmaceutical Holdings, Inc. There is no publicly-held

corporation that owns 10% or more of Apotex Inc.

ill

TABLE OF CONTENTS

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RULE 29.6 CORPORATE DISCLOSURE

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CONSTITUTIONAL AND STATUTORY

PROVISIONS INVOLVED. ........cccccscsessecsseesseeseeeseee i

STATEMENT OF THE CASE .......csssssesssessseessesssessseersesseenses 3

REASONS FOR GRANTING THE WRIT........c.cccessee0ee+- 12

i. Despite Med/mmune, The Federal Circuit

Continues To Misapply Controlling Precedent

From This Court, As It Did In This Case................. 12

IT. The Federal Circuit’s Decision Seriously

Undermines Congress’s Determination To

Enhance Generic Pharmaceutical Competition

For The Benefit Of The American Public................ 18

RPO RPI TN tian Gani ciesigunkincins desacaael iad aoe aad 24

APPENDIX

Appendix A - Opinion of the United States Court

of Appeals for the Federal Circuit Decided

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Appendix B — Opinion of the United States District

Court for the District of New Jersey Filed

Na a scddaanan 23a

Appendix C — Order of the United States Court of

Appeals for the Federal Circuit Denying Petition

for Rehearing Filed October 29, 2008 .............cccceseeeseees 3la

Appendix D — U.S. CONST., art. TTE,“§ 2..........sc0ccosccccssoseeess 33a

Appendix E — 21 U.S.C.A. § 355(j)(5)(C)

(West Supp. 2008).................. als casanah sesinkeseaiocd xisciphiabadba 34a

Appendix F ~ 35 U.S.C.A. § 271(e)(5)

PR NN, GINIE Be socccasnsegiltiicsiensassunenervanhsdechacixeaaesanans 39a

TABLE OF AUTHORITIES

Federal Cases

Aetna Life Ins. Co. v. Haworth,

PE ee EFT Picisnkswesvanisirdincsveteensnpetincencaiinss 10, 13, 14

Altvater v. Freeman,

ee IEE is cikikcs dss duit dcaidsinsnndvaaaschanussamesvaseutedenee 13

Apotex, Inc. v. Pfizer Inc.,

De Es UD, BE EST GAIN, © ZOU A boca crccintccessescssoccncasess 21

Bennett v. Spear,

RPE Ts phicticvscascinevictpiaccncnndinienescucedgrinesiate 10, 14

Caraco Pharm. Labs., Ltd. v. Forest Labs., Inc.,

ee Ro 2) Re ee es 2: a 9, 10, 11

Cardinal Chem. Co. v. Morton Int'l, Inc.,

I eas ii schicken ch Obiinappevinvneindvavoesnareroooten 13, 14

Clements v. Fashing,

AE ST CINE es itierssitennseeveivnnccstnesicnskubicescetenvns 10, 17

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

he FE a iainininsecacsiessegascevasnstisenens sae egal 5,19

In re Barr Labs., Inc.,

EF ces LOPE Wevisnnseceesivssickessenvosansienceccoedans 19

Janssen Pharmaceutica N.V. y. Mylan Pharms., Inc.,

223 Fed. App’x 999, 2007 WL 1428462

CR eats NE Bs UE Bice ccs heic psc cessesesanskcovicoiciecvenubelieas 1]

Md. Cas. Co. v. Pac. Coal & Oil Co.,

I is on one lenono banned i rdosdebaoresndaesoresed 13

MedImmune, Inc. v. Genentech, Inc.,

RAE Saas FI LM TD csnticosehevindnsenisarvasessetasersccresvenees passim

Ne. Fla. Chapter of the Associated Gen. Contractors

of Am. y. City of Jacksonville, Florida,

PI Ae RE MR ichrssnrysetinsecyccsssvasssedassivnsesdvsnssneeve 10, 17

Pfizer Inc. v. Teva Pharms. USA, Inc.,

Case No. 2:05-cv-00620-DRD-MAS (D.N.J.)........... 20-21

Regents of Univ. of Cal. v. Bakke,

Re RF Respendteanesstseassavecesetsiusssessvesnsienavenevs 10, 17

Roche Prods., Inc. v. Bolar Pharm. Co.,

Fee ee Le Gee Be Rsvccncensscccnsceceesccssoscnsnosocenenes 19

Steel Co. v. Citizens for a Better Env’'t,

Be I a stincscscnstigiassdicsscasvsientaesscncinsssnaeen 10, 14

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

BE Pie FAS es GAR. BIT Pissssevarcsssseseresecsessencsescesveses 14

Teva Pharms. USA, Inc. v. Pfizer Inc.,

De Fe rs GWE. BOGS ivccssccnsncnscrcsevcssevesensesicaneanees 20

Teva Pharms. USA, Inc. v. Pfizer, Inc.,

Fe BO be CE OG GAT: ZIG piv resecnnsscsessesccsosnssesessconnavens 13

TorPharm, Inc. v. Pfizer Inc.,

No. 03-990-SLR, 2004 WL 1465756

I Re Is cicsccnsiasntnvsesvasadeesesvncsssrsesanscensenses 20

Watt v. Energy Action Educ. Found.,

ee ec acnsussenivacawvnsnineseeseskerscodonyarese 10, 17

Vii

Federal Statutes

PEGI OPO a csicicisnsivaiccivessisoicassscisusssneness 4,7, 18

DE RB I aad vies ssiisssaicsbechavcssscsccrnichasecean 4

21 U.S.C. § 355(j)(2)(A)(ViIN(EV) coseccesccscecseecssseessesesecesesesseees 4

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21 U.S.C. § 355(j)(5)(B)(iV)(I]) ...sseccseecsseeessessssecssveseseesseee 6-7

21 U.S.C. § 355(j)(5)(C)(i)(ID) vsescsecesescssecccsecessecesecenees 2, 7,19

21 U.S.C. § 355(j)(7)(A) (iii) -.cceecececeeeseeeosee: RONEN 4

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35 U.S.C. § 271(€)(2)(A) ooecesesecssecsssessseessseesseeeesees La

TO Bc iasioiecvsssiccsdccncisnies 2, 8,19

Federal Regulations

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Vill

Other Authorities

149 CONG. REC. 815,746 (Nov. 24, 2003)... ccceccseccesenreees 19

AARP, Prescription Drug Costs and the Role of

Generic Drugs: Public Opinion Among Americans

Aged 43 and Cider (Oct. 1, DOOZ) .cccrccseiveseresveneecscascecsveses 22

H.R. CONF. REP. NO. 108-391 (2003) ...............ssccccrerseeseeeees 19

Jennifer S. Haas, et al., Potential Savings from

Substituting Generic Drugs for Brand-Name Drugs:

Medical Expenditure Pane! Survey, 1997-2000, 142

ANNALS OF INTERNAL MEDICINE 891 (June 7, 2005) ......23

Medicare Prescription Drug, Improvement, and

Modernization Act of 2003,

Pub. L. No. 108-173, 117 Stat. 2066 (2003)................00. 6

National Institute for Health Care Management,

A Primer: Generic Drugs, Patents, and the

Pharmaceutical Marketplace 19 (Juné 2002)..............006 22

SHASHANK UPADHYE, GENERIC PHARMACEUTICAL

PATENT AND FDA LAw (Thomson West 2008) ........... 5, 18

Steven Findlay, Easy Way to Cut Costs of Drugs:

Generics, USA TODAY, May 13, 2004.0... eee 22

Ce. Se GR, Ba aes OE sient svenesBivcseensecencanccizins passim

i. 8 Food and Drug Administration, FDA Announces

Weasures to Improve Generic Drug Access

I: TsO isis wiepsinscccidonabinsh cats: jduannebicidachsiaitin viseliaceeddeuina 22

U.S. Food and Drug Administration, FDA White Paper:

New FDA Initiative on “Improving Access to Generic

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OPINIONS BELOW

The decision of the United States Court of Appeals

for the Federal Circuit (App. la-22a)' for which review by

this Court is sought is available at No. 2008-1062, 540 F.3d

1353 (Fed. Cir. 2008). The decision of the United States

District Court for the District of New Jersey that was

reviewed by the Federal Circuit (App. 23a-30a) is reported at

No. 06-1020 (DMC), 2007 WL 3014702 (D.N.J. Oct. 11,

2007).

JURISDICTION

The Federal Circuit’s judgment for which review by

this Court is sought was entered on September 4, 2008. The

Federal Circuit entered an Order denying Apotex’s combined

petition for panel rehearing and for rehearing en banc on

October 29, 2008. (See App. 3la-32a). This Court has

jurisdiction to review the judgment of the Federal Circuit

under 28 U.S.C. § 1254(1).

CONSTITUTIONAL AND STATUTORY

PROVISIONS INVOLVED

U.S. Constitution, art. III, § 2, cl. 1 provides in

pertinent part:

The judicial Power shall extend to all Cases,

in Law and Equity, arising under this

Constitution, the Laws of the United States,

and Treaties made, or which shall be made,

under their Authority; .

(App. 33a.)

' References to “App. ___” are to the Appendix attached hereto, as

required under Supreme Court Rule 14.1(i).

21 U.S.C.A. § 355(j)(S5)(CXMAD (West Supp. 2005)

provides:

(i) Declaratory judgment absent

infringement action.-

* cd *

(II) Filing of civil action.- If the conditions

described in items (aa), (bb), and as

applicable, (cc) of subclause (I) have been

met, the applicant referred to in such

subclause may, in accordance with section

2201 of title 28, bring a civil action under

such section against the owner or holder

referred to in such subclause (but not against

any owner or holder that has brought such a

civil action against the applicant, unless that

civil action was dismissed without prejudice)

for a declaratory judgment that the patent is

invalid or will not be infringed by the drug for

which the applicant seeks approval... .

(App. 34a-38a.)

35 U.S.C.A. § 271(e)(5) (West Supp. 2005) provides:

Where a person has filed an application

described in paragraph (2) that includes a

certification under subsection (b)(2)(A)(iv) or

(j(2)(A)(vii)(TV) of section 505 of the

Federal Food, Drug, and Cosmetic Act (21

U.S.C. 355), and neither the owner of the

patent that is the subject of the certification

nor the holder of the approved application

under subsection (b) of such section for the

drug that is claimed by the patent or a use of

which is claimed by the patent brought an

action for infringement of such patent before

the expiration of 45 days after the date on

which the notice given under subsection

(b)(3) or ()(2)(B) of such section was

received, the courts of the United States shall,

to the extent consistent with the Constitution,

have subject matter jurisdiction in any action

brought by such person under section 2201 of

title 28 for a declaratory judgment that such

patent is invalid or not infringed.

(App. 39a.)

STATEMENT OF THE CASE

1. This case involves federal court subject matter

jurisdiction, not chemistry. This case involves the tension

between open and free competition in the marketplace versus

the stranglehold over competition by patent law and law of

the U.S. Food and Drug Administration (“FDA”). This case

involves the use of a Declaratory Judgment to pry open the

competitive bottleneck. This petition arises from a patent

dispute between respondents Janssen Pharmaceutica, N.V.

and Janssen, L.P. (collectively, “Janssen”) and petitioner

Apotex. Janssen has patents relating to risperidone oral

solution, which it sells under the brand-name Risperdal®.

Risperdal” is indicated for the treatment of certain mental

disorders, and has generated billions in sales. Apotex

developed a generic version of Risperdal® oral solution and

seeks approval from FDA to market that generic product

pursuant to the Hatch-Waxman Act, which amended the

Federal Food, Drug, and Cosmetic Act.

Relevant here, to protect its monopoly, Janssen listed

with FDA three patents in connection with Risperdal® oral

solution: U.S. Patent Nos. 4,804,663 (“the ‘663 patent’),

5,453,425 (“the ‘425 patent”) and 5,616,587 (“the ‘587

patent”) (collectively, “Janssen’s Orange Book Patents”).’

The ‘663 patent expired on June 29, 2008, while the ‘425

and ‘587 patents do not expire until January 11, 2015.

Apotex followed the statutory procedure for launching its

generic equivalent to Risperdal® oral solution by submitting

to FDA an abbreviated new drug application (“ANDA”)

demonstrating that Apotex’s generic product is

“bioequivalent” to Janssen’s branded Risperdal” oral

solution. Apotex sought FDA approval for its ANDA

product prior to expiration of all three of Janssen’s Orange

Book Patents, representing that those patents are invalid,

unenforceable, or would not be infringed by Apotex’s

ANDA product. See 21 U.S.C. § 355(G)(2)(A)(vii)(TV) (a so-

called “paragraph IV certification”).

Apotex’s paragraph IY certification to Janssen’s

Orange Book Patents constitutes 2 statutory act of patent

infringement sufficient to vest the fzderal courts with subject

matter jurisdiction to resolve patent disputes prior to

Apotex’s actual marketing of its ANDA product. See 21

U.S.C. § 355G)(S)(B)(ii); 35 U.S.C. § 271(e)(2)(A) (making

? Federal law requires Janssen to submit to FDA the number and

expiration date of any patent that claims the “drug” or a “method of using

[the] drug” (here, risperidone) and for which a claim of patent

infringement could reasonably be asserted against an unauthorized party.

See 21 U.S.C. §§ 355(b)(1), (c)(2); 21 C.F.R. §§ 314.53(b), (c)(2). Upon

approval of the branded drug, FDA publishes this patent information in

“Approved Drug Products with Therapeutic Equivalence Evaluations,”

commonly known as the “Orange Book.” See 21 U.S.C.

§ 355G)(7)(A)(iil).

> The ‘663 patent actually expired on December 29, 2007, but Janssen

obtained a 6-month regulatory exclusivity period attaching to that patent.

See 21 U.S.C. § 355a. That period ended on June 29, 2008. Janssen also

obtained a 6-month regulatory exclusivity period for the ‘425 and ‘587

patents, which otherwise would expire on July 11, 2014.

the submission of a paragraph IV certification a statutory act

of patent infringement); Eli Lilly & Co. v. Medtronic, Inc.,

496 U.S. 661, 678 (1990).

While Janssen promptly sued Apotex for alleged

infringement of the earliest-expiring ‘663 patent, Janssen

intentionally refrained from bringing an immediate suit

against Apotex on the later-expiring ‘425 and ‘587 patents.

Janssen did so precisely because the lack of a court decision

on these two patents would indefinitely delay generic

competition for Janssen’s branded Risperdal® product.

Indeed, because Apotex did not file the first ANDA

challenging Janssen’s Orange Book Patents, Janssen’s

strategic decision to hold back suit on the ‘425 and ‘587

patents delays competition in two separate and distinct ways:

First, the failure to resolve the patent controversy

created a substantial cloud of uncertainty over Apotex’s

ability to enter the marketplace because Apotex faced

potentially crippling patent liability if it launched its generic

risperidone product, but ultimately lost its patent challenge.

Second, and more importantly here, the failure to

secure a court judgment of non-infringement or invalidity

precludes Apotex as a matter of law from selling its drug

until at Jeast 180 days after the expiration of the ‘663 patent.

Indeed, Apotex’s approval already has been delayed far

longer than 180 days, and is potentially indefinite.* More

* See SHASHANK UPADHYE, GENERIC PHARMACEUTICAL PATENT AND

FDA LAw § 13:8 (Thomson West 2008), available on Westlaw database:

GENPHARMA (“Because of the law change that occurred in December

2003 with the MMA entering into effect, it is worthwhile to revisit

briefly the law of triggers of that tme. In the pre-MMA world, there

were two triggers of the clock: (1) the commercial marketing trigger; and

(ii) the court decision trigger. An entire cottage industry of litigation

erupted over when is marketing of a product a commercial marketing

and, certainly, what is a court decision that triggers the exclusivity. As to

the commercial marketing trigger, essentially when the ANDA applicant

specifically, federal law grants the first generic manufacturer

to file an ANDA containing a paragraph IV certification (the

so-called “‘first-filer”) the nght to sell its ANDA product as

the only generic product for 180 days, measured from the

earlier to two statutory “triggering events.” See 21 U.S.C.

§ 355(j)(5)(B)(iv).? If Apotex secures a court decision

finding the ‘425 and ‘587 patents invalid or not infringed, the

180-day penod for those patents would begin to run

immediately under the “court decision” tngger. 21 U.S.C.

began marketing its own ANDA-approved product, then it would trigger

its own exclusivity. Because no other later-filed ANDA could be

approved until day 181, it makes sense that the commercial marketing

trigger could only be of the first-to-file’s own ANDA-approved product.

The only odd exception is where the generic company markets the brand

_ product but the FDA considers this as a trigger.

As to the court decision trigger, though, litigation erupted on a

number of points:

* whether the court decision had to be a decision from the first-to-file’s

litigation (if any) or could the court decision come from another's case

* whether the court decision had to be from a district court or an appeals

court

* whether the court decision had to be a “real” substantive holding that

held the patent to be invalid or noninfringed

¢ whether a procedural determination (e.g., the patentee walks away from

the case by dismissing with or without prejudice) triggers the clock

* whether the estoppel effect (or other preclusive effects) qualified as a

court decision (e.g., patentee grants a covenant-not-to-sue)”).

* Because the first ANDA for risperidone oral solution containing a

paragraph IV certification was submitted before December 8, 2003, the

pre-MMA text of § 355(j)(5)(B)(iv) controls. See Medicare Prescription

Drug, Improvement, and Modernization Act of 2003 § 1102(b)(1) and

(3), Pub. L. No. 108-173, 117 Stat. 2066 (2003) (“MMA”). Because

Apotex’s counterclaims on the ‘425 and ‘587 patents were pending “on

or after” enactment of the MMA, Apotex can rely upon the declaratory

judgment provisions of that legislation. See MMA § } !91(c)(1).

§ 355())(5)(B)Gv)UD. Absent such a court decision on the

*425 and ‘587 patents, the first-filer’s exclusivity will not

begin to run until the first-filer begins commercially

marketing its ANDA product under the “commercial

marketing” trigger. Jd. § 355(j)(5)(B)(iv)(I). In this case,

the first-filer has had the legal right to begin marketing its

generic risperidone oral solution product since June 29,

2008. Had the first-filer done so, Apotex would be on the

market by now because Apotex is currently tentatively

approved but-for the 180-day exclusivity bottlenecking

Apotex’s final launch approval. But because the first-filer

has been unable to secure FDA approval of its ANDA

product (and indeed might never be able to secure such

approval), Apotex cannot lawfully obtain approval and begin

marketing, severely injuring both Apotex and the public,

which continues to pay monopoly prices for Janssen’s

branded product when an FDA approvable generic version

(Apotex’s) is ready for immediate marketing. As of today,

the first-filer is not yet finally approved despite having filed

its ANDA in 2002 and having been approvable (but not

approved) since 2006.

Congress enacted a statutory scheme specifically

designed to prevent brand-name manufacturers like Janssen

from delaying generic market entry with the tactics seen

here. Federal law provides that Janssen’s submission of the

‘425 and ‘587 patents to FDA constitutes a representation

that “a claim of patent infringement could reasonably be

asserted” based on this patent against a generic competitor.

21 U.S.C. § 355(6)(1). Further, Apotex’s filing of its ANDA

(with the paragraph IV certification) constituted a siatutory

act of patent infringement of the ‘425 and ‘587 patents. 35

U.S.C. §271(e)(2)(A). In such circumstances, Congress

specifically conferred on the federal courts. jurisdiction over

a declaratory judgment action by a generic manufacturer, 21

U.S.C. § 355G)(S5C)G@UD, and directed that such suits

should be adjudicated to the fullest “extent consistent with

the Constitution,” 35 U.S.C. § 271(e){5).

2. In response to Janssen’s infringement suit on the

‘663 patent, Apotex asserted declaratory judgment

counterclaims with respect to all three of Janssen’s Orange

Book Patents. But in order to improperly maintain its

stranglehold over the relevant market, Janssen moved to

dismiss Apotex’s declaratory judgment counterclaims on the

‘425 and ‘587 patents for lack of subject matter jurisdiction.

Despite this Court’s precedent, under which an actual

controversy exists under Article III of the Constitution any

time (a) there is an actual or imminent injury-in-fact, (b) that

is fairly traceable to the defendant, and (c) is redressible by a

favorable decision, the district court nevertheless dismissed

Apotex’s declaratory judgment counterclaims on the ‘425

and ‘587 patents. (App. 23a-30a). The district court did so

solely based upon an insufficient and unsolicited covenant

not to sue provided by Janssen during the litigation,

concluding that “[w]hile there may have been a case or

controversy prior to [Janssen] providing the covenant not to

sue, nO case or controversy exists regarding the ‘425 and

‘587 patents, as a result of the covenant not to sue.” (App.

26a). The district court’s dismissal is materially inconsistent

with controlling precedent from this Court, including

MedImmune because:

e Apotex is suffering, and continues to suffer,

actual and continuing injury because, absent a

declaratory judgment, (i) the approval of

Apotex’s non-infringing generic risperidone

product is being indefinitely delayed, thus

nullifying Apotex’s significant investments in

research and development, and (11) Apotex to this

day still is unable to launch its generic

risperidone product and compete fairly in the

market, despite the expiration of Janssen’s basic

patent back in June 2008;

e Apotex’s injuries’ result’ directly from

(i) Janssen’s decision to obtain and list the ‘425

and ‘587 patents in FDA’s Orange Book in order

to delay generic competition, thus requiring that

Apotex address such patents in its ANDA, and

(ii) Janssen’s refusal to litigate a legitimate

dispute regarding such patents solely for the

purpose of indefinitely delaying Apotex’s

approval and mainaining Janssen’s monopoly,

which refusal continues to delay Apotex’s

approval just as if Janssen had successfuiiy

asserted such patents; and

e Resolving this conflict would not lead to an

advisory opinion, where a declaration of non-

infringement would allow Apotex to obtain

approval of its product and compete fairly in the

market.

Indeed, even the Federal Circuit agreed that subject matter

jurisdiction existed over Apotex’s declaratory judgment

counterclaims with respect to the ‘425 and ‘587 patents at

the time Apotex filed them. (App. 14a-15a).

3. The Federal Circuit had exclusive jurisdiction

over Apotex’s appeal. 28 U.S.C. § 1295(a)(1). Janssen

argued that because it gave Apotex an unsolicited covenant

not to sue with respect to the ‘425 and ‘587 patents, “there is

no case or controversy” with respect to Apotex’s declaratory

judgment counterclaims to these two patents. Janssen’s

arguments ran contrary to controlling precedent from the

Federal Circuit itself, as well as from this Court. In Caraco

Pharmaceutical Laboratories, Ltd. v. Forest Laboratories,

Inc., 527 F.3d 1278 (Fed. Cir. 2008), which issued after this

Court’s decision in Medimmune and after Apotex filed its

appeal, the Federal Circuit expressly considered whether a

covenant not to sue from a brand company to a subsequent

ANDA filer (such as Apotex here) divests the federal courts

of subject matter jurisdiction. The Federal Circuit in Caraco

correctly concluded in light of precedent from this Court

that, in the Hatch-Waxman context, Article III jurisdiction

exists over an ANDA applicant’s declaratory judgment claim

involving unasserted Orange Book-listed patents, even if the

patentee provides a covenant not to sue with respect to such

patents, because the generic company had an injury-in-fact

sufficient to establish an Article III “case or controversy”

based upon being excluded from selling its non-infringing

drug product due to the brand company’s actions, which

delayed FDA approval. Caraco, 572 F.3d at 1291-94.

The Caraco court’s conclusion is mandated by

several decisions from this Court, including Med/mmune,

127 S. Ct. at 771; Aetna Life Ins. Co. v. Haworth, 300 U.S.

227, 240-41 (1937); Steel Co. v. Citizens for a Better Env’t,

523 U.S. 83, 102-03 (1998); Bennett v. Spear, 520 U.S. 154,

167 (1997); Ne. Fla. Chapter of the Associated Gen.

Contractors of Am. v. City of Jacksonville, Florida, 508 U.S.

656, 664-68 (1993) (finding injury under Article III where

plaintiff was precluded by law from competing); Watt v.

Energy Action Educ. Found., 454 U.S. 151, 160-61 (1981)

(same); Regents of Univ. of Cal. v. Bakke, 438 U.S. 265, 281

& 281 n.14 (1978) (finding Article IJ] injury based on

university’s “decision not to permit [the plaintiff applicant]

to compete for all 100 places in the class”); Clements v.

Fashing, 457 U.S. 957, 962 (1982) (finding Article III injury

based on law that created an “obstacle to [plaintiffs]

candidacy for higher judicial office” (citations omitted)).

While the Federal Circuit decision appealed here

concluded that subject matter jurisdiction existed over

Apotex’s declaratory counterclaims at the time Apotex filed

them (App. 14a-15a), the court nevertheless impermissibly

affirmed the district court’s dismissal on those claims (App.

22a). The Federal Circuit refused to apply Caraco and the

decisions of this Court solely because Apotex stipulated to

the validity of the ‘663 patent — a patent that expired in 2008,

nearly seven years before the ‘425 and ‘587 patents will

expire in 2014.° (App. 14a-16a). The Federal Circuit further

concluded that any delay in the approval of Apotex’s

risperidone oral solution ANDA “was too speculative to

create an actual controversy to warrant the issuance of a

declaratory judgment.” (App. 20a). In other words, the

Federal Circuit refused to apply this Court’s precedent to

find subject matter jurisdiction even though the situation

presented here and in Caraco admittedly are identical, other

than the fact that Apotex recognized the validity of an

earlier-expiring patent after the Federal Circuit upheld that

patent’s validity. The Federal Circuit’s ruling cannot

lawfully stand. First, under this Court’s precedent, that

Apotex stipulated to the validity of the earlier-expiring ‘663

patent has no legal significance with respect to the Article III

case or controversy surrounding its declaratory judgment

claims to the ‘425 and ‘587 patents, which again, do not

expire until 2014. Second, Apotex’s harm is far from

“speculative.” Indeed, it is difficult to envision more real,

immediate, and concrete injuries than those which Apotex

currently suffers. The ‘663 patent expired in June 2008, yet

Apotex still cannot launch its ANDA product because the

* Apotex stipulated to the validity of the ‘663 patent only after the

Federal Circuit found that patent to be valid in litigation involving

another generic company. See Janssen Pharmaceutica N.V. v. Mylan

Pharms., Inc., 223 Fed. App’x 999, 2007 WL 1428462 (Fed. Cir. May

11, 2007) (unpublished), aff’g 456 F. Supp. 2d 644 (D.N.J. 2006).

” Apotex’s injury continues as the first-filer has yet to launch despite the

expiration of the relevant blocl.ing patent in June 2008.

180-day generic exclusivity has not yet started, let alone

expired. And there simply is no telling when (if ever) that

exclusivity might expire absent a court decision on the ‘425

and ‘587 patents.

REASONS FOR GRANTING THE WRIT

The Federal Circuit’s holding that manufacturers in

Apotex’s position are forbidden from maintaining a

declaratory judgment action, pursuant to the Federal law

enacted for this precise purpose, merits this Court’s review.

That decision simply cannot be reconciled with this Court’s

precedents interpreting the case or controversy requirement

of Article III, including the Court’s recent Med/mmune

decision. The question is, moreover, of indisputable

importance not only to the generic pharmaceutical industry,

but also to the public, which relies so heavily — particularly

in these financially troubled times — on that industry to

provide lower-priced, affordable versions of life-saving

drugs. Indeed, given the Federal Circuit’s continued

misapplication of this Court’s precedent, it is critical that this

Court take up this issue directly in a Hatch-Waxman patent

infringement case. Accordingly, this Court should grant

certiorari. At the very least, the Court should invite the

Solicitor General to file a brief expressing the views of the

United States on this vitally important issue because generic

drugs are cheaper for the consuming public and for payors,

like Health and Human Services.

I. Despite MedImmune, The Federal Circuit

Continues To Misapply Controlling Precedent

From This Court, As It Did In This Case.

In early 2007, this Court made clear that a

declaratory judgment plaintiff need not satisfy the Federal

Circuit’s judge-made “‘reason apprehension” test in order for

subject matter jurisdiction to exist. Med/mmune, 127 S. Ct.

at 774 n.11. Indeed, this Court even discussed the Federal

Circuit decision upon which Janssen relied in the district

court when it sought to dismiss Apotex’s claims in this case,

Teva Pharmaceuticals USA, Inc. v. Pfizer, Inc., 395 F.3d

1324, 1333 (Fed. Cir. 2005) (“Teva’’), when so concluding:

Even if Altvater [v. Freeman, 319 US.

359 (1943)] could be distinguished as an

“injunction” case, it would still contradict the

Federal Circuit’s ‘reasonable apprehension of

suit” test (or, in its evolved form, the

“reasonable apprehension of imminent suit”

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

395 F.3d 1324, 1333 (2005)). A licensee who

pays royalties under compulsion of an

injunction has no more apprehension of

imminent harm than a licensee who pays

royalties for fear of treble damages and an

injunction fatal to his _ business. The

reasonable-apprehension-of-suit test also

conflicts with our decisions in Maryland

Casualty Co. v. Pacific Coal & Oil Co., 312

U.S. 270, 273, 61 S.Ct. 510, 85 L.Ed. 826

(1941), where jurisdiction obtained even

though the collision-victim defendant could

not have sued the declaratory-judgment

plaintiff-insurer without first obtaining a

judgment against the insured; and Aetna Life

Ins. Co. v. Haworth, 300 U.S. 227, 239, $7

S.Ct. 461, 81 L.Ed. 617 (1937), where

jurisdiction obtained even though the very

reason the insurer sought declaratory relief

was that the insured had given no indication

that he would file suit. It is also in tension

with Cardinal Chemical Co. v. Morton Int'l,

Inc., 508 U.S. 83, 98, 113 S.Ct. 1967, 124

L.Ed.2d 1 (1993), which held that appellate

affirmance of a judgment of noninfringement,

eliminating any apprehension of suit, does not

moot a declaratory judgment counterclaim of

patent invalidity.

MedIimmune, 127 S. Ct. at 774 n.11. Thus, this Court

expressly overruled the reasonable apprehension test.

Moreover, and significantly here, this Court once

again confirmed that the only prerequisite to jurisdiction

under the Declaratory Judgment Act is an “actual

controversy” under Article I], which merely requires: (1) an

actual or imminent injury-in-fact, (2) that is fairly traceable

to the defendant, and (3) is redressible by a favorable

decision. See id. at 771; see also Aetna, 300 U.S. at 239-41;

Steel Co., 523 U.S. at 103-04; Bennett, 520 U.S. at 167;

Cardinal Chem., 508 U.S. at 95-96.5 The Federal Circuit’s

conclusion below that Apotex’s stipulation to the validity of

the ‘663 patent somehow rendered its harm “too speculative

to create an actual controversy to warrant the issuance of a

declaratory judgment” (App. 20a; see a/so App. 14a-15a)

runs contrary to this binding precedent.

® A few months later, in another Hatch-Waxman ANDA patent case, the

Federal Circuit acknowledged that Med/mmune overruled the

“reasonable apprehension” test. See Teva Pharms. USA, Inc. v. Novartis

Pharms. Corp., 482 F.3d 1330, 1338-39 (Fed. Cir. 2007) (hereinafter,

Novartis”). As the Novartis court went on to hold, the only

question in this [ANDA] case is whether [the generic

company] has a justiciable controversy within Article

ill, which is the only limitation on our jurisdiction

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

§ 2201. An Article III controversy is found where a

plaintiff has demonstrated an injury-in-fact caused by

the defendant that can be redressed by the court. See

Steel Co., 523 US. at 83, 118 S.Ct. 1003.

Novartis, 482 F.3d at 1340.

That Apotex stipulated to the validity of the earlier-

expiring ‘663 patent has no legal significance whatsoever

with respect to the Article II] case or controversy

surrounding its declaratory judgment claims to the “425 and

‘587 patents, and further, the considerable injuries that

Apotex continues to suffer based upon its inability to market

its generic drug product are far from “speculative.”

Allowing the Federal Circuit’s decision to stand not only

would run contrary to this Court’s precedent, but also would

place generic companies back in the same untenable position

that existed under the Federal Circuit’s reasonable

apprehension test.

In listing the ‘425 and ‘587 patents with FDA,

Janssen formally took the position that generic competitors

were subject to suit for infringement of those patents if they

marketed prior to their expiration. Apotex seeks to market

its generic product before the ‘425 and ‘587 patents expire,

and maintains that its product would not infringe those

patents or that they are invalid. Apotex currently is injured

by virtue of Janssen’s conduct, irrespective of Apotex’s

stipulation to the validity of the now-expired ‘663 patent.

Janssen’s conduct prevented Apotex from entering

the marketplace immediatcly upon expiration of the ‘663

patent in June 2008, and continues to prevent Apotex’s

marketing even today, because federal law prohibits FDA

from finally approving Apotex’s generic product until the

180-day generic exclusivity period expires. But absent a

court decision with respect to the ‘425 and ‘587 patents, that

exclusivity period wil] not begin to run until the first-filer

markets its generic product. Here, however, the first-filer for

generic risperidone oral solution has yet to obtain the

approval needed to launch its product, and even assuming it

can ever obtain such approval, there is no guarantee that it

will immediately launch its product. Thus, Apotex’s market

entry remains blocked indefinitely. No one can reasonably

dispute that Apotex suffers considerable, immediate and on-

going injury given that (i) the approval of its non-infringing

generic risperidone product is being delayed, thus nullifying

Apotex’s significant investments in research and

development, and (ii) Apotex, to this day, still is unable to

launch its generic risperidone product and compete fairly in

the market, despite the expiration of Janssen’s basic patent

more than seven months ago. Indeed, even the Federal

Circuit below conceded that Article II jurisdiction existed

over Apotex’s declaratory judgment counterclaims with

respect to the ‘425 and ‘587 patents at the time Apotex filed

them. (App. 14a-15a).

The only reason the Federal Circuit refused to find

jurisdiction over Apotex’s counterclaims to the ‘425 and

‘587 patents is because Apotex stipulated to the validity of

ihe ‘663 patent after the Federal Circuit (in another action)

upheld its validity. (App. 14a-16a). But what Apotex did or

did not do with respect to a patent that expired nearly seven

years before the ‘425 and ‘587 patents will expire in 2014

has no bearing on whether an Article III case or controversy

exists as to Apotex’s declaratory judgment claims to those

later-expiring patents. If the ‘663 patent had never existed

and only the ‘425 and ‘587 patents were listed in the Orange

Book, Apotex would still suffer the same injuries that it does

today, and was suffering at the time it brought its declaratory

judgment claims -- namely, the inability to promptly bring an

admittedly _ non-infringing product to market and patent

uncertainty. And again, the Federal Circuit correctly

concluded that jurisdiction existed when Apotex filed its

declaratory judgment claims. Apotex’s injuries have only

increased today, as the approval of its product continues to

be delayed indefinitely based upon Janssen’s actions.

The fact is that under this Court’s precedent, Apotex

had the right to enter the generic drug market with its non-

infringing product immediately upon expiration of the ‘663

patent and Apotex’s exclusion from the generic drug market

by Janssen’s actions is a sufficient Article III injury-in-fact.

See Ne. Fla. Chapter, 508 U.S. at 664-68 (finding injury

under Article II] where plaintiff was precluded by law from

competing); Watt, 454 U.S. at 160-61 (same); Regents, 438

U.S. at 281 & 281 n.14 (finding Article [II injury based on

university’s “decision not to permit [the plaintiff applicant]

to compete for all 100 places in the class”); Clements, 457

U.S. at 962 (finding Article III injury based on law that

created an “obstacle to [plaintiff's] candidacy for higher

judicial office” (citations omitted)).

Notably, the Federal Trade Commission—the

independent government agency charged with protecting

consumers and policing anticompetitive activities—strongly

agrees that parties in Apotex’s position satisfy Article III's

case or controversy requirement under this Court’s

precedent: “The controversy is real and immediate, and is

between adverse parties, because [Janssen’s] conduct creates

a bottleneck that just as surely delays [Apotex] from

receiving FDA approval to market a product as if [Janssen]

had won a preliminary injunction in an infringement suit

against [the competitor].” Teva FTC Panel Br. at 22-23.

“Absent such a decision,” every generic competitor “must

wait for its approval until [the first-filer] has marketed its

product for 180 days .... Thus, the only way that [Apotex]

can advance the date of the approval of its product is through

this litigation. Absent this action, [Apotex] suffers an injury-

in-fact from the lost opportunity to bring its product to

market during the 180 days.” /d. at 21-22.

II. The Federal Circuit’s Decision Seriously

Undermines Congress’s Determination To

Enhance Generic Pharmaceutical Competition

For The Benefit Of The American Public.

The Federal Circuit’s error is all the more grave

because it threatens to nullify an entire statutory scheme.

Congress enacted the declaratory judgment provisions

invoked by Apotex in this case for the express purpose of

permitting suits, such as Apotex’s, to go forward in order to

ensure that the American public has prompt access to

essential, less-expensive generic medicines.

Before the 1984 Hatch-Waxman Act, a generic

company had to wait until the patent protecting a drug

product expired before it could even begin the lengthy

process of preparing its application for submission to FDA.

And because such testing can, and often does, take years, the

brand company continued to monopolize that particular drug

Market years afier patent expiration as the generic company

worked io complete the necessary tests and waited for FDA

approval. This unintended period of extended market

exclusivity often was referred to as a “de facto” patent term

extension. See generally SHASHANK UPADHYE, GENERIC

PHARMACEUTICAL PATENT AND FDA LAW § 9:2 (Thomson

West 2008), available on Westlaw database: GENPHARMA

(discussing the genesis of the Hatch-Waxman Act and

eliminating the de facto extension).

In 1984 and again in 2003, Congress amended the

statute in numerous respects in order to speed generic

competition. Congress provided that: (a) a brand-name

manufacturer’s submission of a patent to FDA constitutes a

representation that “a claim of natent infringement could

reasonably be asserted,” 21 U.S.C. § 355(b)(1); (b) the filing

of an ANDA claiming patent non-infringement or invalidity

constitutes a statutory act of patent infringement, 35 U.S.C.

§ 271(e)(2)(A); (c) federal courts have jurisdiction over such

a declaratory judgment action by a generic manufacturer, 21

U.S.C. § 355G)(5)(C)(DUD; 35 U.S.C. § 271(e)(5S); and (d)

such suits should be adjudicated to the fullest “extent

consistent with the Constitution,” 35 U.S.C. § 271(e)(5).°

Through this scheme, Congress sought to “enable the

judicial adjudication upon which the ANDA.. . scheme[]

depend[s].” Eli Lilly, 496 U.S. at 678. Congress correctly

recognized the substantial national interest in getting

“generic drugs into the hands of patients at reasonable

prices—fast,” Jn re Barr Labs., Inc., 930 F.2d 72, 76 (D.C.

Cir. 1991), and specifically sought to ensure that “courts will

find jurisdiction, where appropriate, to prevent an improper

effort to delay infringement litigation between generic drug

manufacturers and pioneer drug companies,’ H.R. CONF.

Rep. No. 108-391, at 836 (2003). To effectuate that goal,

Congress enacted the declaratory judgment provisions to

“ensure that the 180-day exclusivity period enjoyed by the

first generic to challenge a patent cannot be used as a

bottleneck to prevent additional generic competition.” 149

CONG. REC. $15,746 (Nov. 24, 2003).

The Federal Circuit’s continued refusal to correctly

apply this Court’s precedent for determining the existence of

an Article III case or controversy accordingly will have far-

reaching, negative consequences for generic pharmaceutical

companies and the American public that depends upon

generic companies like Apotex to bring more affordable

drugs to market quickly. Because the Federal Circuit has

* Congress also specifically overturned the Federal Circuit’s holding that

any company that manufactured or used a patented drug while compiling

the data necessary to complete an application for FDA approval of a

generic drug could be sued for infringement, see Roche Prods., Inc. v.

Bolar Pharm. Co., 733 F.2d 858, 861-63 (Fed. Cir. 1984), superseded by

35 U.S.C. §271(e)(1), which was a principal source of brand name

manufacturers’ de facto patent term extensions.

exclusive jurisdiction over patent disputes, the ruling below

governs every attempt in the nation by generic

pharmaceutical companies to resolve patent disputes with

brand manufacturers. The decision below provides a

roadmap for brand manufacturers to preclude litigation of all

such disputes. The Federal Circuit’s ruling encourages brand

companies to delay infringement litigation, and as a result,

the market entry of much-needed affordable generic drugs.

Teva Pharms. USA, Inc. v. Pfizer Inc., 405 F.3d 990, 994-95

(Fed. Cir. 2005) (Gajarsa, J., dissenting) (“No incumbent

will ever make the threat [of litigation], if it can simply nde

out the term in the listed patent.”).

Thus, the Federal Circuit’s decision, by misapplying

this Court’s precedent, cnpples generic competition by

leaving generic companies like Apotex under a deb. litating

cloud of patent uncertainty and outrightly precludes

marketing for a substantial period. Consequently, it

seriously undermines Congressional efforts to accelerate the

introduction of generic drugs and thereby ameliorate the

staggering cost of prescription drugs in the United States.

Brand-name manufacturers routinely employ the

tactics used by Janssen in this case to delay competition. A

perfect example is Pfizer Inc.’s conduct with respect to the

drug Accupril®, for which Apotex also submitted an ANDA.

Pfizer did not assert all Orange Book patents against generic

companies seeking immediate FDA approval. Apotex filed a

declaratory judgment action in an effort to obtain patent

certainty with respect to its own generic equivalent. A

district court dismissed the suit, however, for lack of a case

or controversy because Pfizer itself refused to file suit. See

TorPharm, Inc. v. Pfizer Inc., No. 03-990-SLR, 2004 WL

1465756 (D. Del. June 28, 2004). But when another generic

competitor (Ranbaxy) entered the market, exposing itself to

massive damages, Pfizer promptly filed suit. See Pfizer Inc.

v. Teva Pharms. USA, Inc., Case No. 2:05-cv-00620-DRD-

MAS (D.N.J.). While several other companies obtained

FDA approval to begin marketing their own generic

Accupril” products, the threat of litigation significantly

delayed generic entry, particularly after Pfizer obtained a

preliminary injunction preventing Ranbaxy’s continued

marketing.

Another example involves Apotex and its attempt to

promptly market a generic version of Pfizer’s Zoloft®. In

order to delay generic competition, Pfizer refused to sue

generic companies, including Apotex, with respect to a

Pfizer Orange Book patent. There, too, Apotex filed a

declaratory judgment action in an effort to obtain patent

certainty with respect to its own generic equivalent. A

district court dismissed the suit for lack of a case or

controversy, and the Federal Circuit affirmed. See Apotex,

Inc. v. Pfizer Inc., 385 F.Supp. 2d 187 (S.D.N.Y. 2005),

aff'd, No. 05-1199, 2005 WL 3457408 (Fed. Cir. Dec. 12,

2005). And this Court denied Apotex’s certiorari petition

after the relevant patent expired. See Apotex, Inc. v. Pfizer

Inc., No. 05-1006. Indeed, this Court did so despite

Apotex’s insistence that this same situation would repeat

itself again and again, including with respect to Apotex’s

generic Risperdal® product, the very generic product at issue

here now. (See No. 05-1006, Declaration of Dr. Bernard C.

Sherman §f 12-13, submitted Sept. 19, 2006, in connection

with the Supplemental Brief for Petitioners).

Thus, at least two things are clear: (1) brand

companies like Janssen have, in effect, created a new “de

facto” exclusivity period in direct contravention of

Congress’s express intent; and (2) they will continue to use

this “de facto” exclusivity period to harm generic companies

like Apotex and the public unless this Court intervenes. The

conseanences for the American public are, in fact,

substantial.

As the Federal Trade Commission advised the

Federal Circuit, “declaratory judgment actions serve an

important role because the [FTC’s] Generic Drug Study

showed iat no generic applicant entered the market prior to

a district court decision addressing the patents that, at the

time of its application, were listed in the Orange Book.”

Teva FTC Panel Br. at 8 n.9 (emphasis added).

The high costs of brand-name prescriptions are a

significant barrier in most cases to proper medical treatment

for many Americans, particularly the elderly. See AARP,

Prescription Drug Costs and the Role of Generic Drugs:

Public Opinion Among Americans Aged 45 and Older at 2

(Oct. 1, 2002) (“[N]Jearly one in four Americans 45 and older

(24%) reported not being able to afford a prescription drug

because no generic version was available.”). Because

generic drugs are sold for a fraction of the prices of their

brand-name counterparts, access to generic pharmaceuticals

is “perhaps the single most important route to lower personal

and national drug costs during the next decade.” Steven

Findlay, Easy Way to Cut Costs of Drugs: Generics, USA

TODAY, May 13, 2004, at 23A,.

As the FDA Commissioner has explained, generic

drugs “‘are an increasingly important way to provide the

American people with safe, effective and affordable medical

treatment.” U.S. Food and Drug Administration, FDA

Announces Measures to Improve Generic Drug Access

(Mar. 2, 2004), available at

www.fda.gov/bbs/topics/NEWS/2004/NEW01030.html; see

also National Institute for Health Care Management, A

Primer: Generic Drugs, Patents, and the Pharmaceutical

Marketplace 19 (June 2002) (suggesting that the “advent” of

generic anti-depressant drugs “may help rectify’ “a

persistent under-diagnosis and under-treatment of depression

in the U.S.”). The cost savings resulting from the

availability of generic drugs is inescapable. Indeed, the

substitution of generic drugs for brand-name drugs results in

billions of dollars in savings each year, without

compromising safety or health.'° Jennifer S. Haas, et al.,

Potential Savings from Substituting Generic Drugs for

Brand-Name Drugs: Medical Expenditure Panel Survey,

1997-2000, 142 ANNALS OF INTERNAL MEDICINE sci, 895

(June 7, 2005) (indicating that “[b]road dispensing of generic

products would achieve savings without compromising

safety,” because “[gleneric drugs are believed to provide

therapeutic effects similar to those of their brand-name

alternatives”); U.S. Food and Drug Administration, FDA

White Paper: New FDA Initiative on “Improving Access to

Generic Drugs” (June 12, 2003), available at

http://www. fda.gov/oc/initiatives/generics/whitepaper. htm]

(recognizing that “Americans need generic drugs more than

ever” and “[b]ringing low-cost generic drug alternatives to

consumers more quickly can significantly reduce overall

health care costs, and increase access to life saving

medicines that are just as safe and effective as their brand-

name counterparts’).

Thus, the decision of the Federal Circuit will have

far-reaching negative effects on the American public, as it

inevitably and unnecessarily delays access to these lower-

cost generic drugs.

'° A study published in the ANNALS OF INTERNAL MEDICINE, concluded

that “broad generic substitution of outpatient prescription drugs could

save approximately $8.8 billion, or approximately 11% of drug

expenditures for adults ... in the United States each year.” Jennifer S.

Haas, et al., Potential Savings from Substituting Generic Drugs for

Brand-Name Drugs: Medical Expenditure Panel Survey, 1997-2000,

142 ANNALS OF INTERNAL MEDICINE 891, 894 (June 7, 2005); see also

Food and Drug Administration, FDA White Paper: New FDA Initiative

on “Improving Access to Generic Drugs” (June 12, 2003), available at

http://www. fda.gov/oc/initiatives/generics/whitepaper.html (reporting

that the average price of a brand-name drug is $72, compared with $17

for its generic counterpart).

CONCLUSION

Tne petition for certiorari should be granted.

Alternatively, the Court should call for the views of the

Solicitor General.

Respectfully submitted,

Shashank Upadhye*

V.P. — Global Head of I.P. Law

Apotex, Inc.

150 Signet Drive

Weston, Ontario M9L 1T9

CANADA

Telephone: (416) 401-7701

Counsel for Petitioner Apotex Inc.

*Counsel of Record

January 27, 2009

APPENDIX

APPENDIX A — OPINION OF THE UNITED

STATES COURT OF APPEALS FOR THE FEDERAL

CIRCUIT DECIDED SEPTEMBER 4, 2008

UNITED STATES COURT OF APPEALS

FOR THE FEDERAL CIRCUIT

No. 2008-1062

JANSSEN PHARMACEUTICA, N.V.

and JANSSEN, L.P,

Plaintiffs-Appellees,

APOTEX, INC.,

Defendant-Appellant.

Appeal from the United States District Court for the

District of New Jersey in case no. 06-CV-1020, Judge

Dennis M. Cavanaugh.

DECIDED: September 4, 2008

Before MICHEL, Chief Judge, RADER and MOORE,

Circuit Judges.

MOORE, Circuit Judge.

Defendant-Appellant Apotex, Inc. (Apotex) appeals

the order of the United States District Court for the

District of New Jersey dismissing its declaratory

Appendix A

judgment action for noninfringement against Plaintiffs-

Appellees Janssen Pharmaceutica, N.V. and Janssen,

L.P. (collectively Janssen). We affirm.

BACKGROUND

‘i

This case arises under the Hatch-Waxman Act (Act),'

which governs the Food and Drug Administration’s

(FDA) approval of new and generic drugs. The goal of

the Act is to better balance two competing interests in

the pharmaceutical industry: “(1) inducing pioneering

research and development of new drugs and (2) enabling

competitors to bring low-cost, generic copies of those

drugs to market.” Andra Pharms., Inc. v. Biovail Corp.,

276 F.3d 1368, 1371 (Fed.Cir.2002).

Under the Act, a pioneering or brand name drug

company seeking to manufacture a new drug must

prepare, file, and have approved a new drug application

(NDA) with the FDA. 21 U.S.C. § 355(a), (b). As part of

its NDA, the applicant must submit information

regarding the new drug’s safety and efficacy obtained

from clinical trials. 21 U.S.C. § 355(b)(1). The applicant

1. The Hatch-Waxman Act is the name commonly used to

refer to the Drug Price Competition and Patent Term

Restoration Act of 1984, Pub.L. No. 98-417, 98 Stat. 1585 (1984)

(codified at 21 U.S.C. §§ 355, 360(ec) (2000), 35 U.S.C. §§ 156,

271, 282 (2000)), as amended by the Medicare Prescription Drug,

Improvement, and Modernization Act of 2003, Pub.L. No. 108-

173, 117 Stat.2066 (2003).

Appendix A

must also identify all patents that “could reasonably be

asserted if a person not licensed by the owner engaged

in the manufacture, use, or sale of the drug,” 21 U.S.C.

§ 355(b)(1), (c)(2). The FDA publishes a list of those

patents in the “Orange Book.” Drugs approved

by the FDA are known as “listed drugs.” 21 U.S.C.

§ 855(j)(2)(A)(i).

To encourage the development of generic versions

of listed drugs, the Act created an expedited approval

process known as an Abbreviated New Drug Application

(ANDA). 21 U.S.C. § 355(j). Generic drug companies are

not required to conduct their own independent clinical

trials to prove safety and efficacy, but can instead rely

on the research of the pioneer pharmaceutical

companies. 21 U.S.C. § 355(j)(2)(A)(iv), (j)(8)(B).

However, in order to rely on the research of the pioneer

pharmaceutical companies, an ANDA applicant is

required to show bioequivalence of its generic drug to

the NDA drug. 21 U.S.C. § 355(j)(2)(A)(iv), (j)(8)(B).

The ANDA applicant must also include a certification

to each patent listed in the Orange Book covering the

listed drug that either (I) no patent information has

been filed with the FDA; (ITI) the patent has expired;

(III) the patent will expire on a particular date and

approval of the ANDA should be deferred until

expiration; or (IV) in the opinion of the ANDA applicant,

the patent is invalid or will not be infringed by the

manufacture, use, or sale of the generic drug. 21 U.S.C.

§ 355(j)(2)(A)(vii). These options are respectively

referred to as Paragraph I, II, III, and IV Certifications.

The timing of ANDA approval is tied to the type of

Appendix A

certification contained in the ANDA. For Paragraph IV

ANDAs, the timing of approval depends upon two

events: (1) whether the pioneer drug company brings

an infringement action within 45 days of learning of the

Paragraph IV ANDA filing, and (2) whether the

company seeking approval was the first one to file an

ANDA containing a Paragraph IV Certification to a

listed patent (hereinafter first Paragraph IV ANDA

filer).

In order to bring about early resolution of patent

disputes between generics and pioneering drug

companies, the Act provides that the filing of a

Paragraph IV Certification is an act of patent

infringement. 35 U.S.C. § 271(e)(2)(A); Eli Lilly & Co.

v. Medtronic, Inc., 496 U.S. 661, 678, 110 S.Ct. 2683,

110 L.Ed.2d 605 (1990). The ANDA filer must provide

notice to the patentee and NDA holder of the factual

and legal bases for the Paragraph IV Certification.

21 U.S.C. § 355(j)(2)(B). Upon such notice, the patentee

and NDA holder have the option of suing on all, some,

or none of the patents included in the Paragraph IV

Certification. If the patentee or NDA holder does not

bring suit within 45 days of receiving notice, the

FDA may issue final approval of the ANDA once its

approval requirements have been satisfied. 21 U.S.C.

§ 355(j)(5)(B)(iii). If, however, the brand name company

brings suit within 45 days, the FDA may not approve

the ANDA for 30 months. 21 U.S.C. § 355(j)(5)(B)(iii).

The FDA may approve the ANDA after that period, or

earlier if a court has decided the patent(s)-in-suit are

invalid or not infringed. 21 U.S.C. § 355(j)(5)(B)(iii).

Appendix A

As an incentive for generic pharmaceutical

companies to challenge suspect Orange Book listed

patents, the Hatch-Waxman Act grants the first

company to submit a Paragraph IV ANDA a 180-day

period of generic marketing exclusivity during which

time FDA will not approve a later-filed Paragraph IV

ANDA based on the same NDA (hereinafter subsequent

Paragraph IV ANDA). 21 U.S.C. § 355(j)(5)(B)(iv);

see Minn. Mining & Mfg. Co. v. Barr Labs., Inc., 289

F.3d 775, 778 (Fed.Cir.2002). Significantly, the first

Paragraph [IV ANDA filer is entitled to the 180-day

exclusivity period regardless of whether it establishes

that the Orange Book patents are invalid or not

infringed by the drug described in its ANDA. All that is

required for the first Paragraph IV ANDA filer to

receive the 180-day exclusivity period is that it

submits a substantially complete ANDA that

containsa Paragraph IV Certification. 21 U.S.C.

§ 355(j)(5)(B)(iv)(ID)(bb).

The start of the 180-day exclusivity period is

triggered by the earlier of two events: (1) the first

Paragraph IV ANDA filer’s commercial marketing of a

drug product; or (2) a court decision of noninfringement

or invalidity. 21 U.S.C. § 355(j)(5)(B)(iv) (2000). Only the

2. In 2003, Congress replaced the provisions governing the

triggering of the 180-day exclusivity period with a regime in

which the 180-day exclusivity period could be forfeited for

various reasons, including the failure of the first Paragraph IV

ANDA filer to launch its generic product within a certain time

period. 21 U.S.C. § 355(j)(5)(D). This amendment was part of

(Cont’d)

Appendix A

first Paragraph IV ANDA filer can trigger its 180-day

exclusivity period via the commercial-marketing trigger.

21 U.S.C. § 355(j)(5)(B)(iv)(1) (2000). However, the

subsequent Paragraph IV ANDA filers can trigger the

first Paragraph [IV ANDA filer’s 180-day exclusivity

period via a successful court judgment. Minn. Mining,

289 F.3d at 780.

On December 8, 2003, the Hatch-Waxman Act was

amended by Title XI of the Medicare Prescription Drug,

Improvement and Modernization Act of 2003(MMA),

Pub.L. No. 108-173, §.1102(a), 117 Stat. 2066, 2457-60.

Prior to the MMA, NDA holders employed several

methods of delaying the early resolution of patent

disputes. See Teva Pharms. USA, Inc. v. Novartis

Pharms. Cerp., 482 F.3d 1330, 13842 & n. 7 (Fed.Cir.2007).

The MMA ameliorates these situations by authorizing

a “a civil action” under 28 U.S.C. § 2201 “for a

(Cont'd)

the Medicare Prescription Drug, Improvement, and

Modernization Act of 2003(MMA), Pub.L. No. 108-173, 117

Stat.2066 (2003). However, the MMA contained a grandfather

provision specifying that the amendments do not apply to

Paragraph |V ANDAs filed before the date of the enactment of

the MMA or te subsequent Paragraph [IV ANDAs filed after

the enactment of the MMA if the first Paragraph [TV ANDA was

filed prior to enactment of the MMA. See MMA § 1102(b). Here,

a generic pharmaceutical company, ‘Teva Pharmaceuticals USA,

Inc., filed the first Paragraph IV ANDA in 2002, before the

December 2003 enactment of the MMA. Thus, the MMA

amendments governing the commencement and forfeiture of

the 180-day exciusivity period are inapplicable to this case.

Appendix A

declaratory judgment that the [listed] patent is

invalid or will not be infringed by the drug for

which the applicant seeks approval... .” 21 U.S.C.

§ 355(j)(5)(C)(i)(II). Specifically, the MMA allows a

Paragraph IV ANDA filer a right to bring a declaratory

judgment action for noninfringement or invalidity of the

relevant listed patents against the patentee and NDA

holder, if the patentee has not brought an infringement

action within the 45-day notice period. 21 U.S.C.

§ 355(j)(5)(C). Congress extended federal] court

jurisdiction over these declaratory judgment actions “to

ihe extent consistent with the Constitution.” 35 U.S.C.

§ 271(e)(5). Therefore, federal courts have jurisdiction

over these declaratory judgment actions to the extent

that they present an Article ITI case or controversy.

Caraco Pharm. Labs. v. Forest Labs., 527 F.3d 1278,

1285 (Fed.Cir.2008) (citation omitted).

il.

Janssen holds an approved NDA for its drug

Risperdal® Oral Solution. The Orange Book originally

listed U.S. Patent Nos. 4,804,663 (‘663 patent), 5,453,425

(‘425 patent) and 5,616,587 (‘587 patent) in connection

with this NDA. The 2 663 patent covers the compound

risperidone, which is the active compound in the drug

Risperdal® Oral Solution. The ‘425 and ‘587 patents

cover specific aqueous solutions of risperidone and

methods for preparing these solutions. The ‘663 patent

expired on December 29, 2007. However, the FDA

granted Janssen an additional six months of pediatric

exclusivity pursuant to 21 U.S.C. § 355a, making June

Appendix A

29, 2008 the effective expiration date of the ‘663 patent.?

The ‘425 and ‘587 patents expire in 2014.

The ‘663 patent has been the subject of prior

litigation. Following a bench trial, it was found to be

infringed, valid, and enforceable. On May 11, 2007, this

court affirmed the judgment of the district court.

Janssen Pharmaceutica, N.V. v. Mylan Pharm., Inc.,

456 F.'Supp.2d 644, 671 (D.N.J.2006), aff'd, 223 Fed.Appx.

999 (Fed.Cir.2007). While Apotex was not a party to that

trial, Apotex stipulated to infringement, validity, and

enforceability of the ‘663 patent based on the Federal

Circuit opinion. Therefore, this stipulation took effect

on May 11, 2007.

Prior to September 2002, Teva Pharmaceuticals

USA, Inc. (Teva) filed an ANDA to make a generic

version of risperidone oral solution. In filing its ANDA,

Teva respected the validity of the ‘663 patent by filing a

Paragraph III Certification on that patent. Teva was

the first ANDA applicant to file a Paragraph IV

Certification on the ‘425 and ‘587 patents. As such, Teva

is entitled to 180 days of generic market exclusivity,

during which the FDA will not approve a later-filed

Paragraph IV ANDA based on the same NDA. Teva’s

180-day exclusivity period will begin either the day it

begins marketing its drug, or on the date a court

determines that the ‘425 and ‘587 patents are invalid or

3. Hereinafter this opinion refers to the expiration of the

‘663 patent’s pediatric exclusivity period as the expiration of

the ‘663 patent.

Appendix A

not infringed-whichever comes first. 21 U.S.C.

§ 355(j)(5)(B)(iv) (2000). As Teva filed a Paragraph III

Certification with respect to the ‘663 patent, the FDA

will not approve Teva’s generic product before the

expiration of the ‘663 patent. Because Janssen did not

sue Teva for infringing the ‘425 and ‘587 patents, the

FDA will be able to approve Teva’s generic version of

risperidone oral solution upon the expiration of the ‘663

patent. Teva will be able to commercially market its

generic product immediately upon receiving FDA

approval.

Apotex subsequently submitted an A IDA

application to the FDA seeking approval to market its

generic version of risperidone oral solution, in which

Apotex also filed Paragraph IV Certifications on the ‘425

and ‘587 patents. In January 2006, Apotex amended its

ANDA and provided Janssen with an additional

Paragraph IV Certification directed to the ‘663 patent.

On March 3, 2006, Janssen sued Apotex for infringing

the ‘663 patent in the United States District Court for

the District of New Jersey, but Janssen did not sue

Apotex on the ‘425 and ‘587 patents (collectively, the

unasserted patents). In its Answer to Janssen’s

Complaint on April 25, 2006, Apotex asserted four

counterclaims, including claims for declaratory

judgment of noninfringement of the two unasserted

patents. Specifically, Apotex sought a declaratory

judgment of noninfringement with respect to the two

unasserted patents under the Declaratory Judgment

Act, 28 U.S.C. § 2201, and the MMA to the Hatch-

Waxman Act, 21 U.S.C. § 355(j)(5)(C) and 35 U.S.C. §

10a

Appendix A

271(e)(5).4 On June 28, 2006, Janssen moved to dismiss

these two counterclaims on the ground that the action

did not present a case or controversy as required by

Article III of the Constitution.

On December 8, 2006, Janssen provided Apotex with

a covenant-not-to-sue with respect to the ‘425 and ‘587

patents. After granting the covenant, Janssen

requested that Apotex withdraw its counterclaims.

Apotex refused. On October 11, 2007, the district court

granted Janssen’s motion to dismiss Apotex’s

counterclaims for lack of subject matter jurisdiction. The

district court found “no case or controversy” regarding

the ‘425 and ‘527 patents. This appeal followed.

DISCUSSION

Whether an “actual controversy” exists that is

sufficient to sustain federal subject matter jurisdiction

is a question of law this court reviews de novo. Teva

Pharms. USA, Inc. v. Novartis Pharms. Corp., 482 F.3d

1330, 1335-36 (Fed.Cir.2007). In the ANDA context,

Congress extended federal court jurisdiction under the

Declaratory Judgment Act, 28 U.S.C. § 2201, to ANDA

Paragraph IV disputes, 21 U.S.C. § 355(j)(5)(C).

Congress also directed federal courts to exercise

jurisdiction over these AN DA Paragraph IV declaratory

4. Because Apotex’s counterclaims on the ‘425 and ‘587

patents were pending “on or after” the enactment of the MMA

(December 8, 2003), Apotex can rely upon the declaratory

judgment provision of that legislation. See MMA § 1101(c)(1).

lla

Appendix A

judgment actions “to the extent consistent with the

Constitution,” 35 U.S.C. § 271(e)(5). The relevant text

of the Declaratory Judgment Act reads:

In a case of actual controversy within its

jurisdiction ... any court of the United States,

upon the filing of an appropriate pleading, may

declare the rights and other legal relations of

any interested party seeking such declaration,

whether or not further relief is or could be

sought.

28 U.S.C. § 2201(a). The Declaratory Judgment Act’s

“actual controversy” requirement “refers to the type

of ‘Cases’ and ‘Controversies’ that are justiciable under

Article III.” MedJmmune, Inc. v. Genentech, Inc., 549

U.S. 118, 127 S.Ct. 764, 771, 166 L.Ed.2d 604 (2007).

In MedImmune, the Supreme Court stated that a

justiciable declaratory judgment action exists when:

the facts alleged, under all the circumstances,

show that there is a substantial controversy,

between parties having adverse legal

interests, of sufficient immediacy and reality

to warrant the issuance of a declaratory

judgment.

Id. at 771 (citation omitted). The Court emphasized that

the dispute must be:

“definite and concrete, touching the legal

relations of parties having adverse legal

12a

Appendix A

interests;” and that it be “real and

substantial” and “admi[t] of specific relief

through a decree of a conclusive character, as

distinguished from an opinion advising what

the law would be upon a hypothetical state of

facts.”

Id.

Apotex argues that it is suffering three actual and

continuing injuries which create a substantial

controversy of sufficient immediacy to warrant the

issuance of a declaratory judgment. Specifically, Apotex

argues that (1) itis unable to promptly launch its generic

risperidone product and compete in the market

immediately upon the expiration of the ‘663 patent;

(2) its approval of its noninfringing generic risperidone

product is being indefinitely delayed; and (3) its

affiliates, suppliers, and downstream customers face

patent uncertainty because Janssen’s covenant-not-to-

sue does not cover them. We address each alleged injury

in turn.

A. Prompt Launch

Apotex argues that absent a declaratory judgment

with respect to the ‘425 and ‘587 patents and regardless

of Janssen’s grant of a covenant-not-to-sue, it continues

to suffer a cognizable harm of being unable to launch

its generic risperidone product immediately upon the

expiration of the ‘663 patent. Apotex contends that this

injury creates a substantial controversy of sufficient

13a

Appendix A

immediacy to warrant the issuance of a declaratory

judgment. Without a declaratory judgment, Teva’s 180-

day exclusivity period will commence when it

commercially launches its generic risperidone product

after the expiration of the ‘663 patent. Therefore, the

earliest Apotex will be able to enter the market is 181

days after the expiration of the “663 patent. However, if

Apotex is successful on its declaratory judgment action,

Teva’s 180-day exclusivity period will be triggered at a

time that Teva will be unable to launch its generic

product. If Teva’s 180-day exclusivity period is exhausted

prior to the expiration of the ‘663 patent, Apotex will be

able to enter the market immediately upon the

expiration of the ‘663 patent.°®

5. As Teva was the first Paragraph IV ANDA filer with

respect to the ‘425 and ‘587 patents, it is entitled to a 180-day

exclusivity period. Teva’s 180-day exclusivity period can be

triggered by one of two events: (1) Teva’s commercial launch of

its product; or (2) a favorable court judgment with respect to

both the ‘425 and ‘587 patents. Because Teva filed a Paragraph

III Certification for the ‘663 patent, the FDA cannot approve

Teva’s ANDA until the ‘663 patent expires. As Teva cannot launch

prior to FDA approval, the earliest Teva can market its generic

product is at the expiration of the ‘663 patent. Moreover, because

Teva failed to obtain a favorable court judgment with respect

to the ‘425 and ‘587 patents, Teva will only be able to trigger its

180-day exclusivity period by commercially launching its

generic product. A subsequent Paragraph IV ANDA filer can

trigger Teva’s 180-day exclusivity period by obtaining a court

judgment that both the ‘425 and ‘587 patents are invalid or

noninfring »'. Therefore, if Apotex obtains a favorable court

judgment on the ‘425 and ‘587 patents, Teva’s 180-day

(Cont'd)

14a

Appendix A

Apotex contends that Caraco Pharm. Labs. v. Forest

Labs., 527 F.3d 1278 (Fed.Cir.2008), in which this court

held that despite the existence of a covenant-not-to-sue,

a declaratory judgment claim brought under the Hatch-

Waxman Act presents a justiciable Article III

controversy, is controlling. We disagree.

Jurisdiction over a declaratory judgment action

must be present “at all stages of review, not merely at

the time the complaint is filed.” Steffel vu. Thompson,

415 U.S. 452, 459 n. 10, 94 S.Ct. 1209, 39 L.Ed.2d 505

(1974); see Benitec Austl., Ltd. v. Nucleonics, Inc., 495

F.3d 1340, 1344 (Fed.Cir.2007) (“The burden is on the

party claiming declaratory judgment jurisdiction to

establish that such jurisdiction existed at the time the

claim for declaratory relief was filed and that it has

continued since.”); /nt’l Med. Prosthetics Research

Assocs., Inc. v. Gore Enter. Holdings, Inc., 787 F.2d 572,

575 (Fed.Cir.1986) (“[J]urisdiction over [ ] a declaratory

judgment action [must have] existed at, and has

continued since, the time the complaint was filed.”). We

agree with the parties that if Apotex had not stipulated

to the validity of the ‘663 p: tent, then Caraco would

have been controlling. However, Apotex stipulated to

the validity, infringement, and enforceability of the ‘663

patent on May 11, 2007. Therefore, while the harm that

(Cont'd)

exclusivity period will begin immediately-regardless of

whether the ‘663 patent has expired. This would result in Teva’s

180-day exclusivity period beginning during a time when it

cannot secure FDA approval and therefore cannot launch its

product.

l5a

Appendix A

created a justiciable Article III controversy in Caraco

was present when Apotex filed its counterclaims on April

25, 2006, that harm ceased to exist upon Apotex’s

stipulation. As such, the harm that gave rise to

jurisdiction over the declaratory judgment claims in

Caraco was no longer present on October 11, 2007—the

date the district court dismissed the instant case.

Further, we conclude that the harm that has continuously

existed in the present case-Apotex’s inability to launch

its generic product immediately upon the expiration of

the ‘663 patent—is not sufficient to give rise to

declaratory judgment jurisdiction.

In Caraco, Forest Laboratories Inc., et al. (Forest)

was the pioneer pharmaceutical company, Ivax

Pharmaceuticals, Inc. (Ivax) was the first Paragraph IV

ANDA filer, and Caraco Pharmaceutical Laboratories,

Ltd. (Caraco) was the subsequent Paragraph IV ANDA

filer. 527 F.3d at 1286, 1288. Forest listed two patents in

the Orange Book in relation to its NDA. /d. at 1286.

Both Ivax and Caraco filed Paragraph IV ANDAs with

respect to both of the listed patents. /d. at 1286, 1288.

Forest chose to sue Ivax on only one of the two listed

patents. /d. at 1286. Forest’s patent was found valid,

iniringed, and enforceable. /d. (citing Forest Labs., Inc.

v. Ivax Pharms., Inc., 501 F.3d 1263 (Fed.Cir.2007)).

After Caraco filed its Paragraph IV ANDA, Forest sued

Caraco on only the pr. viously litigated patent and

granted a covenant-not-t« sue on the unlitigated,

unasserted patent. Jd. at 1288. Caraco brought a

declaratory judgment action for noninfringement of the

unlitigated, unasserted patent. Jd. Caraco wanted to be

16a

Appendix A

able to chaiienge both patents and if successful, this

would trigger Ivax’s 180-day exclusivity period at a time

when Ivax could obtain FDA approval and then launch

its product. Hence, if Caraco was successful, Ivax would

get its 180-day exclusivity period sooner and Caraco

would be able to obtain FDA approval earlier-resulting

in greater competition at an earlier time. Without a

declaratory judgment, Caraco could be excluded from

selling a noninfringing product even if the asserted

patent was proven to be invalid. See zd. at 1287, 1296

n.14. Therefore, Caraco could have been blocked from

entering the market by an invalid patent. Jd.

The key difference between Caraco and this case is

that the harm that gave rise to the jurisdiction over the

declaratory judgment claim in Caraco ceased to exist

once Apotex stipulated to the validity, infringement, and

enforceability of the ‘663 patent. Therefore, unlike

Caraco, Apotex cannot claim that at the time of the

district court’s dismissal it was being excluded from

selling a noninfringing product by an invalid patent—it

stipulated to the validity of the ‘663 patent. Even if

Apotex successfully invalidates the ‘425 and ‘527 patents,

it cannot obtain FDA approval until the expiration of

the ‘663 patent because of its stipulations with respect

to that patent. Instead, the harm to Apotex that has

continuously existed is its exclusion from selling its

alleged noninfringing product during Teva’s statutorily

entitled 180-day exclusivity period. Apotex is being

excluded from the market by Teva’s 180-day exclusivity

period-a period which Teva is entitled to under the

Hatch-Waxman Act. This is a different injury than that

alleged in Caraco.

17a

Appendix A

Apotex’s inability to promptly launch its generic

risperidone product because of Teva’s 180-day

exclusivity period is not a cognizable Article III

controversy, but a result envisioned by the Hatch-

Waxman Act. As noted above, the Hatch-Waxman Act

struck a careful balance between encouraging the

development of new drugs and enabling the marketing

of low-cost generic drugs. See Andrx Pharms., 276 F.3d

at 1371. To this end, Congress decided to give generic

pharmaceutical companies a 180-day exclusivity period

as an incentive to challenge suspect Orange Book listed

patents. The 180-day exclusivity period is important to

generic pharmaceutical companies as it promotes patent

challenges by enabling a generic company a period to

recover its investment in these challenges. See C. Scott

Hemphill, Paying for Delay: Pharmaceutical Patent

Settlement as a Regulatory Design Problem, 81 N.Y.U.

L.Rev. 1553, 1605 (2006) (noting the importance of the

180-day exclusivity period for decreasing the free-rider

problem and concomite™tly incentivizing challenges of

Orange Book listed patents); see also Purepac Pharm.

Co. v. TorPharm, Inc., 354 F.3d 877, 879 (D.C.Cir.2004)

(“In order to encourage paragraph I\ challenges,

thereby increasing the availability of low-cost generic

drugs... [the first Paragraph IV ANDA filer] has the

right to sell its drug without competition [from other

generic entrants] for 180 days.”). As the import of the

180-day exclusivity period is clear, we hold that Apotex’s

exclusion from the market because of Teva’s entitlement

to this statutory exclusionary period does not present a

justiciable Article III controversy.

18a

Appendix A

B. Indefinite Delay

Second, Apotex argues that absent a declaratory

judgment action, its approval of its noninfringing generic

risperidone product will be indefinitely delayed until

Teva’s 180-day exclusivity period is triggered. Apotex

contends that Teva does not have to commercially launch

immediately after the expiration of the ‘663 patent, and

that Teva may indefinitely delay launching for various

reasons (i.e., substantive problems with its applications

which may prevent FDA approval; stock-piting drug

product; or concerns over brand patents).

Apotex filed its counterclaims seeking declaratory

judgment of noninfringement of the ‘425 and ‘587

patents on April 25, 2006. At this time, Teva could not

launch its generic product for at least another two years.’

The district court dismissed the counterclaims on

October 11, 2007 more than six months before Teva

could have launched. Final judgment was entered on

November 2, 2007. At the time of the final judgment

dismissing the counterclaims, the harm alleged by

Apotex was too speculative because Teva could not yet

have launched. We heard oral arguments in this case on

July 7, 2008, approximately a week after Teva could have

6. In 2003, Congress eliminated the possibility that the first

Paragraph [IV ANDA filer may indefinitely delay launching its

generic product. See supra note 2.

7. The earliest Teva could have launched its generic

product was on June 29, 2008—the expiration of the ‘663 patent

pediatric exclusivity period.

19a

Appendix A

launched its generic product.’ However, we are not

deciding whether the facts alleged on July 7, 2008—the

date we heard oral arguments—give rise to a justiciable

Article III case or controversy.’ We hold that at the time

8. At the time we heard oral argument, both parties agreed

that Teva had not yet launched its generic risperidone oral

solution.

9. Jurisdiction over a declaratory judgment action must

be present “at all stages of review, not merely at the time the

complaint is filed.” Steffel, 415 U.S. at 459 n. 10,94 S.Ct. 1209. As

noted above, the court was divested of jurisdiction on May 11,

2007 the date that Apotex’s stipulated to the validity,

enforceability, and infringement of the ‘663 patent. In limited

circumstances, temporary jurisdictional defects—defects that

arise after the filing date oi the complaint-may be cured before

the district court enters final judgment. See Mars, Inc. v. Coin

Acceptors, Inc., 527 F.3d 1359, 1370 (Fed.Cir.2008) (holding that

patentee must reacquire title to a patent prior to final iudgment

to correct the jurisdictional defect that arises when the plaintiff

loses title to the patent during litigation); Schreiber Foods, Inc.

v. Beatrice Cheese, Inc., 402 F.3d 1198, 1203 (Fed.Cir.2005) (“In

circumstances where dismissal for lack of initial standing is

not required, the Supreme Court held in Caterpillar [Jnc. v.

Lewis, 519 U.S. 61, 117 S.Ct. 467, 1386 L.Ed.2d 437 (1996),] that

jurisdictional defects can be cured before judgment.”);

Insituform Tech., Inc. v. CAT Contracting, Inc., 385 F.3d 1360,

1371-72 (Fed.Cir.2004) (holding that temporary loss of

jurisdiction during patent litigation can be cured before final

judgment). As Apotex failed to cure the jurisdictional defect

by the time the district court entered final judgment, we need

not reach the issue of whether this case constitutes one of the

limited circumstances in which temporary jurisdictional defects

can be cured.

20a

Appendix A

when the district court entered final judgment in this

case, Apotex’s alleged harm of indefinite delay of

approval was too speculative to create an actual

controversy to warrant the issuance of a declaratory

judgment.

At no time between the filing of the counterclaims

through the final judgment was there any basis to

conclude that Teva will, or is likely to, delay in bringing

its generic product to market in the future. In Caraco,

this court considered the same harm that Apotex alleges

and concluded that it was insufficient to create a

justiciable Article III case or controversy. See Caraco,

527 F.3d at 1296 n. 14 (noting possible delay of the first

Paragraph IV ANDA filer launching after the expiration

of a patent is too speculative to create a justiciable

Article III case or controversy). Our decision in Caraco

is supported by Supreme Court precedent which has

emphasized that the dispute must be “definite and

concrete” and be “real and substantial” in order to give

rise to justiciable Article III case or controversy.

MedImmune, 127 S.Ct. at 771; see Prasco, LLC v.

Medicis Pharm. Corp., 537 F.3d 1329, 1339

(Fed.Cir.2008) (noting Med/mmune “did not change the

bedrock rule that a case or controversy must be based

on a real and immediate injury . .. an objective standard

that cannot be met by a purely subjective or speculative

fear of future harm”). Therefore, we hold that a possible

delay in the future of a first Paragraph IV ANDA filer

in launching its generic product does not give rise to

declaratory judgment jurisdiction.

2la

Appendix A

C. Covenant-Not-to-Sue

Finally, Apotex argues that Janssen’s covenant-not-

to-sue is deficient as it does not protect Apotex’s

affiliates, suppliers, and downstrearn customers. We

disagree. The relevant portion of Janssen’s covenant-

not-to-sue states:

Janssen unconditionally covenants not to sue

or otherwise seek to hold Apotex liable based

on its manufacture, having manufactured,

importation, distribution, use, sale and/or

offering for saie of the risperdal ora) solution,

1 mg/ml that are described in and the subject

of Abbreviated New J)rug Application No. 77-

719, as filed and as provided to counsel for

Janssen on or about July 13 2nd 25, 2006 (“the

ANDA”), for infringement of United States

Patents Nos. 5,453,425 (“the ‘425 patent”)

[and] 5,616,587 (“the ‘587 patent”). ...

Similarly, Janssen would not sue or otherwise

seek to hold Apotex’s customers or

distributors liable based upon the

importation, distribution, use, sale and/or

offering for sale of the risperdal oral solution,

1 mg/m] that are described in and the subject

of the ANDA for infringement of the ‘425

patent [and] the ‘587 patent... .

The covenant expressly gives Apotex protection from

suit for “manufacture [and/or] having manufactured” the

claimed product. The “having manufactured” language

22a

Appendix A

expressly covers all suppliers and affiliates involved in

the manufacturing process. See Cyrix Corp. v. Intel

Corp., 77 F.3d 1381, 13888 (Fed.Cir.1996) (“ST acted within

the scope of its ‘have made’ right under the ST-Intel

agreement when it had ST-Italy make the

microprocessors and then sold them to Cyrix.”).

Similarly, the covenant protects all of Apotex’s customers

without any distinction between direct and downstream

customers as it states “[s]Jimilarly, Janssen would not

sue or otherwise seek to hold Apotex’s customers and

distributors liable. .. .” Therefore, we hold Janssen’s

covenant-not-to-sue is not deficient, as it protects

Apotex’s affiliates, suppliers and downstream

customers.

CONCLUSION

As we conclude no jurisdiction existed for Apotex’s

declaratory judgment action, we need not address the

remainder of the parties’ arguments. For the foregoing

*1364 reasons, we affirm the district court’s dismissal

of Apotex’s declaratory judgment action.

AFFIRMED

23a

APPENDIX B — OPINION OF THE UNITED

STATES DISTRICT COURT FOR THE DISTRICT

OF NEW JERSEY FILED OCTOBER 11, 2007

UNITED STATES DISTRICT COURT

DISTRICT OF NEW JERSEY

Hon. Dennis M. Cavanaugh

Civil Action No. 06-cv-1020(DMC)

JANSSEN PHARMACEUTICA, N.V. and

JANSSEN PHARMACEUTICA PRODUCTS,

Plaintiffs,

APOTEX, INC.,

Defendant.

OPINION

DENNIS M. CAVANAUGH, U.S.D.J.:

This matter comes before the Court upon Plaintiffs

Janssen Pharmaceutica, N.V. and Janssen

Pharmaceutica Products, L.P’s (Plaintiffs) motion to

dismiss Defendant Apotex’s Counterclaims III and IV

regarding U.S. Patent Numbers 5,453,425 (the ‘425

patent) and 5,616,587 (the ‘587 patent) pursuant to

Fed.R.Civ.P 12(b)(1) and Defendant Apotex’s motion for

24a

Appendix B

summary judgment seeking a declaratory judgment of

non-infringement of the ‘425 patent and the ‘587 patent

pursuant to Fed.R.Civ.P 56 and L.Civ.R. 56.1. Pursuant

to Rule 78 of the Federal Rules of Civil Procedure, no

oral argument was heard. After carefully considering

the submissions of the parties, and based on the

following, this Court finds that Plaintiffs’ motion to

dismiss Defendant’s Counterclaims III and IV is

granted. As such, Defendant’s motion for summary

judgment is moot.

I. Background!

Plaintiffs are the patent owners for various forms

of risperidone. Specifically, Plaintiffs own “Risperidone

Oral Formulation”, which is the ‘425 patent and

“Aqueous Risperidone Formulations”, which is the ‘587

patent. Apotex is a manufacturer of various products,

including the generic versions of Plaintiffs’ ‘425 and ‘587

patents, which it has researched and prepared for

market. On or about March 3, 2006, Plaintiffs filed suit

against Defendant, and other entities alleging patent

infringement of U.S. Patent No. 4,804,663 (the ‘663

patent) for risperidone oral solution. On or about April

26, 2006, Defendant filed an answer and counterclaims,

among other claims, seeking declaratory judgments of

non-infringement of the ‘425 and ‘587 patents.

Defendant agreed to be bound by a final, unappealable

decision in the actions brought against the other entities

1. The facts set forth in this Opinion are taken from the

undisputed facts in each party’s moving papers.

25a

Appendix B

regarding the “663 patent. On October 2, 2007, this Court

entered a Judgment in favor of Plaintiffs and against

Defendant with respect to the infringement claims of

the “663 patent.

On June 28, 2006, Plaintiffs filed the present motion

to dismiss Defendant’s Counterclaims III and IV,

pertaining to patents ‘425 and ‘587. On January 30, 2007,

Defendant filed the present motion for summary

judgment for non-infringement of patents ‘425 and ‘587.

On February 21, 2007, Judge Lifland Ordered a Stay of

the summary judgment motion until this Court decided

the motion to dismiss.

Plaintiffs move to dismiss Defendant's

Counterclaims III and IV pursuant to Fed.R.Civ.P.

12(b)(1) for lack of subject matter jurisdiction.

Counterclaims III and IV seek declaratory judgment

of non-infringement of patents ‘425 and ‘587 as

Defendant alleges without Janssen’s approval, it would

be unable to market the competing generic drugs.

Plaintiffs listed the ‘663, ‘425 and ‘587 patents in

the United States Food and Drug Administration’s

“Orange Book” in connection with Plaintiffs’ New Drug

Application (NDA) for risperidone. The ‘663 patent

covers the compound risperidone and the ‘425 and ‘587

patents cover aqueous solutions for risperidone and

methods for preparing these solutions; thus, the ‘425

and ‘587 patents require more than simply risperidone.

26a

Appendix B

Prior to September 16, 2005, Defendant submitted

an abbreviated new drug application (ANDA) seeking

to engage in the commercial manufacture of the generic

version of risperidone oral solution. On September 16,

2005, Defendant sent Plaintiff a Paragraph IV

Certification for the ‘425 and ‘587 patents. On January

26, 2006, Defendant amended its ANDA to assert a

Paragraph IV Certification against the ‘663 patent.

Plaintiff acted within 45 days of receiving the additional

Paragraph IV Certification and brought a patent

infringement suit regar<:ng the ‘663 patent only. As

shown above, this patent infringement is no longer in

issue. In its Answer to Plaintiffs’ Complaint, Defendant

counterclaims alleging non-infringement of the ‘425 and

‘587 patents and seeks declaratory judgment from this

Court holding that Defendant has not infringed patents

‘425 or ‘587.

On December 8, 2UUc, Plaintiffs provided Defendant

with a covenant not to sue for infringement of the ‘425

and ‘587 patents. This covenant not to sue protects

Defendant and Defendant’s customers and distributors.

While there may have been a case or controversy prior

to Plaintiffs providing the covenant not to sue, no case

or controversy exists regarding the ‘425 and ‘587

patents, as a result of the covenant not to sue. As such,

this Court finds that Plaintiffs’ motion to dismiss

Defendant’s Counterclaims III and IV, pertaining to the

‘425 and ‘587 patents is granted and Defendant’s motion

for summary judgment is moot.

27a

Appendix B

II. Standard of Review

MoTIonN To Dismiss PurRSUANT TO RULE 12(b)(1)

Upon a Rule 12(b)(1) motion addressing the

existence of subject matter jurisdiction over a plaintiff’s

complaint, “no presumptive truthfulness attaches to a

plaintiff’s allegations.” Martinez v. U.S. Post Office, 875

F. Supp. 1067, 1070 (D.N.J.1995) (citing Mortensen v.

First Fed. Sav. and Loan Ass’n, 549 F.2d 884, 891 (8d

Cir. 1977)). “Accordingly, unlike a Rule 12(b)(6) motion,

consideration of a Rule 12(b)(1) jurisdiction-type motion

need not be limited; conflicting written and oral evidence

may be considered and a court may ‘decide for itself the .

factual issues which determine jurisdiction.” /d. (citing

Williamson v. Tucker, 645 F.2d 404, 413 (5th Cir.) cert.

denied, 454 U.S. &97 (1981)). “When resolving a factual

challenge, the court may consult materials outside the

pleadings, and the burden of proving jurisdiction rests

with the plaintiff.” Med. Soc’y of N..J. uv. Herr, 191 F. Supp.

2d 574, 578 (D.N.J. 2002) (citing Gould Elecs. Inc. v.

U.S., 220 F.3d 169, 176, 178 (3d Cir. 2000)). However,

“[w]here an attack on jurisdiction implicates the merits

of plaintiff’s [Federal cause of action, the district court’s

role in judging the facts may be more limited.” Martinez,

875 F. Supp. at 1071 (citing Williamson, 645 F.2d at 413

n.6).

ItI. Discussion

After carefully reviewing the record and papers

submitted by all parties, and based on the following, this

28a

Appendix B

Court finds that Plaintiffs’ motion to dismiss

Defendant’s counterclaims III and IV is granted

because there is no case or controversy surrounding the

patents Defendant alleges are in issue.

At the time Plaintiffs filed their motion to dismiss,

Teva Pharms. USA, Inc. v. Pfizer, Inc., 395 F.3d 1324

(Fed. Cir. 2005) was controlling law, which applied a two

part test to determine whether there was a case or

controversy. The two-part test required both an explicit

threat or other action by the patentee which creates a

reasonable apprehension of suit and present activity

which would constitute infringement. /d. at 1332.

MedIimmune, Inc. v. Genetech, Inc., 127 U.S. 764

(2007) is now controlling law to determine whether a

justiciable declaratory judgment action exists.

“Whether the facts alleged, under all the circumstances

show that there is a substantial controversy, between

the parties having adverse legal interests, of sufficient

immediacy and reality to warrant the issuance of a

declaratory judgment.” /d. at 768. This Court, after

considering the totality of the circumstances, finds that

no substantial controversy exists and Plaintiffs’ motion

to dismiss Defendant’s Counterclaims IYI and IV is

granted.

Defendant asserts that Teva Pharmaceuticals

USA, Inc. v. Novartis Pharmaceuticals, 482 F.3d 1330

establishes that Med/mmune is entirely applicable to

the facts in this case, and thus mandates that subject

matter jurisdiction exists in this declaratory judgment

29a

Appendix B

action. However, the present action is distinguished

from Novartis as Plaintiffs point out, there was no

covenant not to sue in Novartis. Novartis at 1332.

In reaching its decision in Novartis, the Circuit

reviewed the legislative history of the declaratory

judgment provision of the Hatch-Waxman Act? and held

that a covenant not to sue usurps the opportunity to

bring an action for declaratory judgment.

We believe that the only circumstance in which

a case or controversy might not exist would

arise in the rare circumstance in which the

patent owner and brand drug company have

given the generic applicant a covenant not to

sue, or otherwise formally acknowledge that

the generic applicant’s drug does not infringe.

Novartis at 1338. In this case, a covenant not to sue

was given to Defendant on December 8, 2056. Further,

in Merck & Co. v. Apotex, (06-230), The United States

District Court for the District of Delaware issued an

Order on April 10, 2007 granting Merck’s motion to

dismiss for lack of subject matter jurisdiction because

of Merck’s covenant not to sue.

2. The Drug Price Competition and Patent Term

Restoration Act of 1984, 21 U.S.C. §§355, 360ce and 35 U.S.C.

§§156, 271, 282 is commonly known as The Hatch-Waxman Act.

The Act requires an innovator pharmaceutical company that

seeks to manufacture a new brand drug to file a New Drug

Application with the Federal Food and Drug Administration.

30a

Appendix B

The same situation arises here. Plaintiffs gave

Defendant a covenant not to sue, and therefore

Plaintiffs’ motion to dismiss regarding the patents in

the covenant not to sue must be granted.

IV. Conclusion

Based on the foregoing facts and law, it is clear that

there is no case or controversy regarding patents ‘425

and ‘587, and as such, this Court does not have subject

matter jurisdiction and must dismiss Defendant’s

counterclaims III and IV. Plaintiffs’ motion to dismiss

Defendant’s Counterclaims III and IV is granted and

Defendant’s motion for summary judgment seeking

declaratory relief regarding patents ‘425 and ‘587 is

moot. An appropriate Order accompanies this Opinion.

S/ Dennis M. Cavanaugh

Dennis M. Cavanaugh, U.S.D.J.

Date: October 11 , 2007

3la

APPENDIX C — ORDEK OF THE UNITED STATES

COURT OF APPEALS FOR THE FEDERAL

CIRCUIT DENYING PETITION FOR REHEARING

FILED OCTOBER 29, 2008

UNITED STATES COURT OF APPEALS

FOR THE FEDERAL CIRCUIT

2008-1062

JANSSEN PHARMACEUTICA, N.V. and

JANSSEN PHARMACEUTICA PRODUCTS, L.P,

Plaintiffs-Appellees,

APOTEX, INC.,

Defendant-Appellant.

Appeal from the United States District Court for the

District of New Jersey in case no. 06-CV-1020, Judge

Dennis M. Cavanaugh.

ORDER

A combined petiticn for panel rehearing and for

rehearing en banc having been filed by the Appellant,

and a response thereto having been invited by the court

and filed by the Appellees, and the petition for rehearing

and response, having been referred to the panel that

heard the appeal, and thereafter the petition for

32a

Appendix C

rehearing en banc and response having been referred

to the circuit judges who are in regular active service,

UPON CONSIDERATION THEREOF it is

ORDERED that the petition for panel rehearing be,

and the same hereby is, DENIED and it is further

ORDERED that the petition for rehearing en banc

be, and the same hereby is, DENIED.

The mandate of the court will issue on November 5,

2008.

FOR THE COURT,

s/ Jan Horbaly

Clerk

Dated: 10/29/2008

33a

APPENDIX D — US. CONST., ART, IIT, § 2

CONSTITUTION OF THE UNITED STATES

ARTICLE III

Section 2. The judicial Power shall extend to all Cases,

in Law and Equity, arising under this Constitution, the

Laws of the United States, and Treaties made, or which

shall be made, under their Authority;—to all Cases

affecting Ambassadors, other public Ministers and

Consuls;—to all Cases of admiralty and maritime

Jurisdiction;—to Controversies to which the United

States shall be a Party;—io Controversies between two

or more States;—between a State and Citizens of

another State;—between Citizens of different States;—

between Citizens of the same State claiming Lands

under Grants of different States, and between a State,

or the Citizens thereof, and foreign States, Citizens or

Subjects.

34a

APPENDIX E —- 21 U.S.C.A. § 355(j)(5)(C)

(West Supp. 2005)

TITLE 21 - FOOD AND DRUGS

CHAPTER 9 - FEDERAL FOOD, DRUG, AND

COSMETIC ACT

SUBCHAPTER V - DRUGS AND DEVICES

PART A - DRUGS AND DEVICES

§ 355. New drugs

(j) Abbreviated new drug applications

* *

CERTAINTY.—

(i) DECLARATORY JUDGMENT ABSENT

INFRINGEMENT ACTION.—

(I) INGENERAL.—

No action may be brought under section 2201 of

title 28, by an applicant under paragraph (2) for a

declaratory judgment with respect to a patent

35a

Appendix E

which is the subject of the certification referred to

in subparagraph (B)(iii) unless—

(aa) the 45-day period referred to in such

subparagraph has expired;

(bb) neither the owner of such patent nor the

holder of the approved application under

subsection (b) of this section for the drug that is

claimed by the patent or a use of which is claimed

by the patent brought a civil action against the

applicant for infringement of the patent before the

expiration of such period; and

(cc) in any case in which the notice provided under

paragraph (2)(B) relates to noninfringement, the

notice was accompanied by a document described

in subclause (III).

(II) FILING OF CIVIL ACTION,—

If the conditions described in items (aa), (bb), and

as applicable, (cc) of subclause (I) have been met,

the applicant referred to in such subclause may, in

accordance with section 2201 of Title 28, bring a

civil action under such section against the owner

or holder referred to in such subclause (but not

against any owner or holder that has brought such

a civil action against the applicant, unless that civil

action was dismissed without prejudice) for a

declaratory judgment that the patent is invalid or

will not be infringed by the drug for which the

36a

Appendix E

applicant seeks approval, except that such civil

action may be brought for a declaratory judgment

that the patent will not be infringed only in a case »

in which the condition described in subclause (I)(cc)

is applicable. A civil action referred to in this

subclause shall be brought in the judicial district

where the defendant has its principal place of

business or a regular and established place of

business.

(III) OFFER OF CONFIDENTIAL ACCESS

TO APPLICATION.—

For purposes of subclause (I)(cc), the document

described in this subclause is a document

providing an offer of confidential access to the

application that is in the custody of the applicant

under paragraph (2) for the purpose of determining

whether an action referred to in subparagraph

(B)(iii) should be brought. The document providing

the offer of confidential access shali contain such

restrictions as to persons entitled to access, and .

on the use and disposition of any information

accessed, as would apply had a protective order

been entered for the purpose of protecting trade

secrets and other confidential business

information. A request for access to an application

under an offer of confidential access skal! be

considered acceptance of the offer of confidential

access with the restrictions as to persons entitled

to access, and on the use and disposition of any

information accessed, contained in the offer of

37a

Appendix E

confidential access, and those restrictions and

other terms of the offer of confidential access shall

be considered terms of an enforceable contract.

Any person provided an offer of confidential access

shall review the application for the sole and limited

purpose of evaluating possible infringement of the

patent that is the subject of the certification under

paragraph (2)(A)(vii)(IV) and for no other purpose,

and may not disclose information of no relevance

to any issue of patent infringement to any person

other than a person provided an offer of

confidential access. Further, the application may

be redacted by the applicant to remove any

information of no relevance to any issue of patent

infringement.

(ii) COUNTERCLAIM TO INFRINGEMENT

ACTION.—

(1) INGENERAL.—

If an owner of the patent or the holder of the

approved application under subsection (b) of this

section for the drug that is claimed by the patent

or a use of which is claimed by the patent brings a

patent infringement action against the applicant,

the applicant may assert a counterclaim seeking

an order requiring the holder to correct or delete

the patent information submitted by the holder

under subsection (b) or (c) of this section on the

ground that the patent does not claim either—

38a

Appendix E

(aa) the drug for which the application was

approved; or

(bb) an approved method of using the drug.

_(I) NO INDEPENDENT CAUSE OF

ACTION.—

Subclause (I) does not authorize the assertion of a

claim described in subclause (I) in any civil action

or proceeding other than a counterclaim described

in subclause (1).

Gii) NO DAMAGES.—

An applicant shall not be entitled to damages in a

civil action under clause (i) or a counterclaim under

clause (ii).

39a

APPENDIX F —- 35 U.S.C.A. § 271(e)(5)

(West Supp. 2005)

TITLE 35 - PATENTS

PART III - PATENTS AND PROTECTION OF

PATENT RIGHTS

CHAPTER 28 - INFRINGEMENT OF PATENTS

§ 271. Infringement of patent

* * *

(e) * * *

(5) Where a person has filed an application described

in paragraph (2) that includes a certification under

subsection (b)(2)(A)(iv) or (j)(2)(A)(vii)(IV) of section 505

of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.

355), and neither the owner of the patent that is the

subject of the certification nor the holder of the

approved application under subsection (b) of such

section for the drug that is claimed by the patent or a

use of which is claimed by the patent brought an action

for infringement of such patent before the expiration of

45 days after the date on which the notice given under

subsection (b)(3) or (j)(2)(B) of such section was received,

the courts of the United States shall, to the extent

consistent with the Constitution, have subject matter

jurisdiction in any action brought by such person under

section 2201 of title 28 for a declaratory judgment that

such patent is invalid or not infringed.

This is a copy of a public record, reproduced as it was published. It is not legal advice, and it may not be the version a court would rely on. Check the official source before you cite it.