Document ID: s3://data.kl3m.ai/documents/govinfo/USCOURTS/USCOURTS-ca13-14-01282/USCOURTS-ca13-14-01282-0/pdf.json

Parties Involved:
Apotex Inc.
Appellant
Daiichi Sankyo Co., Ltd.
Appellee
Daiichi Sankyo, Inc.
Appellee
Mylan Pharmaceuticals Inc.
Cross-Appellant

Document Text:

United States Court of Appeals 

for the Federal Circuit ______________________ 

APOTEX INC.,

Plaintiff-Appellant

v.

DAIICHI SANKYO, INC., DAIICHI SANKYO CO., 

LTD.,

Defendants-Appellees

v.

MYLAN PHARMACEUTICALS INC.,

Movant-Cross-Appellant

______________________ 

2014-1282, 2014-1291

______________________ 

Appeals from the United States District Court for the 

Northern District of Illinois in No. 1:12-cv-09295, Judge 

Sharon Johnson Coleman.

______________________ 

Decided: March 31, 2015

______________________ 

 STEVEN ERIC FELDMAN, Husch Blackwell LLP, Chicago, IL, argued for plaintiff-appellant. Also represented by 

SHERRY LEE ROLLO, JAMES PATRICK WHITE, DANIEL 

RONALD CHERRY. 

Case: 14-1282 Document: 82-2 Page: 1 Filed: 03/31/2015
2 APOTEX INC. v. DAIICHI SANKYO, INC. 

DOMINICK A. CONDE, Fitzpatrick, Cella, Harper & 

Scinto, New York, NY, argued for defendants-appellees. 

Also represented by CHARLES AUSTIN GINNINGS, NINA 

SHREVE. 

MICHAEL SHUMSKY, Kirkland & Ellis LLP, Washington, DC, argued for movant-cross-appellant. Also represented by JOHN KEVIN CRISHAM, STEPHEN S. SCHWARTZ. 

______________________ 

Before TARANTO, MAYER, and CLEVENGER, Circuit 

Judges.

TARANTO, Circuit Judge. 

Apotex, Inc. brought this action against Daiichi 

Sankyo Co., Ltd. and Daiichi Sankyo, Inc. (collectively, 

Daiichi) to obtain a declaratory judgment that Apotex will

not infringe a patent owned but disclaimed by Daiichi if 

Apotex manufactures or sells a generic drug bioequivalent 

to Daiichi’s Benicar®. Apotex cannot infringe the patent, 

because Daiichi has disclaimed it, but Apotex nevertheless claims a concrete interest in obtaining a judgment of 

non-infringement for its generic drug because such a 

judgment would enable Apotex to receive marketing 

approval from the United States Food and Drug Administration and to enter the market sooner than otherwise. 

The district court dismissed Apotex’s complaint for lack of 

a case or controversy. We reverse. Under the statute that 

governs marketing approval of generics, Apotex has a 

concrete, potentially high-value stake in obtaining the 

judgment it seeks; and Daiichi has a concrete, potentially 

high-value stake in denying Apotex that judgment and 

thereby delaying Apotex’s market entry—as does Mylan 

Pharmaceuticals, Inc., the first applicant for approval of a 

generic version of Benicar®. We also reverse the district 

court’s denial of Mylan’s motion to intervene in this 

action. 

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APOTEX INC. v. DAIICHI SANKYO, INC. 3

BACKGROUND

Under the authority of the FDA’s approval of its New 

Drug Application (NDA), 21 U.S.C. § 355(a), (c), Daiichi 

markets Benicar® for treating hypertension. In seeking 

FDA approval for Benicar®, Daiichi listed two patents in 

the FDA’s Approved Drug Products with Therapeutic 

Equivalence Evaluations publication, or “Orange Book.” 

See 21 U.S.C. § 355(b)(1) (requiring listing of 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 C.F.R. §§ 314.3, 314.53. The first, U.S. Patent 

No. 5,616,599, covers the active ingredient of the drug, 

olmesartan medoxomil. It expires on April 25, 2016, but

because Daiichi provided the FDA certain data concerning 

the drug’s effects on children, the FDA must wait six 

months longer—i.e., until October 25, 2016—before approving a generic version of the drug. See 21 U.S.C. 

§ 355a(b)(1)(B)(i). Daiichi’s second listed patent, U.S. 

Patent No. 6,878,703, covers methods of treatment. It

expires on November 19, 2021. 

At least two generic manufacturers have sought approval from the FDA to market generic olmesartan medoxomil products. All parties agree that Mylan (actually 

Matrix Laboratories, which is now Mylan) was the first to 

seek approval: it filed an Abbreviated New Drug Application (ANDA) with the FDA, under 21 U.S.C. § 355(j), in 

April 2006. In that application, Mylan certified under 

paragraph IV of § 355(j)(2)(A)(vii) that both the ’599 and 

’703 patents were invalid or would not be infringed by 

Mylan’s proposed drug. 

In early July 2006, after receiving notice of Mylan’s 

paragraph IV certification, Daiichi disclaimed all claims 

of the ’703 patent. See 35 U.S.C. § 253. The record does 

not tell us why. We have no information about whether, 

for example, Daiichi recognized the invalidity of the 

patent or, even, that it never should have been listed 

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4 APOTEX INC. v. DAIICHI SANKYO, INC. 

under § 355(b)(1)’s “could reasonably be asserted” standard. 

Having disclaimed the ’703 patent, Daiichi sued 

Mylan for infringing the ’599 patent, invoking the declaration of 35 U.S.C. § 271(e)(2)(A) that the submission of a 

paragraph IV certification constitutes an act of infringement. Only validity was disputed in the case, and after a 

full trial, the district court upheld the validity of the ’599 

patent and entered judgment of infringement against 

Mylan. Daiichi Sankyo Co. v. Mylan Pharm. Inc., 670 F. 

Supp. 2d 359, 387 (D.N.J. 2009). We affirmed. Daiichi 

Sankyo Co. v. Matrix Labs., Ltd., 619 F.3d 1346 (Fed. Cir. 

2010). With the ’703 patent disclaimed and the ’599 

patent upheld, Mylan’s earliest date of market entry—the 

earliest effective date of any FDA approval for Mylan—is 

October 25, 2016, six months after the expiration date of 

the ’599 patent. 

In June 2012, four years before that date and roughly 

two years after the ’599 litigation was over, Apotex filed 

its own ANDA for generic olmesartan medoxomil. Apotex 

included two different certifications under 21 U.S.C. 

§ 355(j)(2)(A)(vii). One was a paragraph III certification 

accepting, rather than disputing, the result of the 2006–

2010 litigation. That certification states that the ’599 

patent is valid and that Apotex’s product would infringe, 

thereby barring an effective date of FDA approval any 

earlier than October 25, 2016. See § 355(j)(5)(B)(ii). 

Apotex’s other certification was a paragraph IV certification stating that Apotex’s product would not infringe the

’703 patent. 

As is undisputed here, non-infringement of the ’703 

patent follows as a matter of law from the fact that 

Daiichi has formally disclaimed it. See Altoona Publix 

Theatres, Inc. v. American Tri-Ergon Corp., 294 U.S. 477, 

492 (1935); Guinn v. Kopf, 96 F.3d 1419, 1422 (Fed. Cir. 

1996). Indeed, in its July 2006 letter asking the FDA to 

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APOTEX INC. v. DAIICHI SANKYO, INC. 5

remove the ’703 patent from the Orange Book, Daiichi 

stated: “The effect of the disclaimer is that the 6,878,703 

patent no longer exists.” J.A. 99. And in July 2012, it 

wrote to Apotex stating that, because of its disclaimer of 

the ’703 patent, it “cannot . . . sue any entity . . . for 

infringement of that patent.” J.A. 104.

Daiichi did not sue Apotex for infringing the ’703 patent, and the FDA has not removed the ’703 patent from 

the Orange Book, despite Daiichi’s 2006 request. See

Teva Pharm. USA, Inc. v. Sebelius, 595 F.3d 1303, 1317–

18 (D.C. Cir. 2010) (patent owner’s unilateral request to 

remove patent from Orange Book is not a sufficient basis 

for FDA to do so). But Apotex sued Daiichi in the United 

States District Court for the Northern District of Illinois 

under 21 U.S.C. § 355(j)(5)(C)(i) and 35 U.S.C. § 271(e)(5), 

seeking a declaratory judgment that its product would not 

infringe the disclaimed ’703 patent. Mylan moved to 

intervene, and both it and Daiichi moved to dismiss 

Apotex’s complaint. Given the non-infringement consequence of the Daiichi disclaimer, the dispute in the district court was not over the merits of infringement. 

Rather, the dispute was over whether, precisely because 

non-infringement is indisputable, the district court must 

deny the requested declaratory judgment for lack of a case 

or controversy. 

Apotex asserted that it has a concrete stake in securing the requested declaratory judgment because, under 

the governing statutory provisions, the requested judgment would allow it to enter the market earlier than it 

could without the judgment. Two statutory provisions are 

key. First: Under § 355(j)(5)(B)(iv), because Mylan was 

the first to file an ANDA for generic olmesartan medoxomil and has maintained a paragraph IV certification 

regarding the ’703 patent, Mylan is presumptively entitled to a period of 180 days of exclusivity—starting whenever, after October 25, 2016, it enters the market—before 

facing competition from another seller of generic olmesarCase: 14-1282 Document: 82-2 Page: 5 Filed: 03/31/2015
6 APOTEX INC. v. DAIICHI SANKYO, INC. 

tan medoxomil. That exclusivity period would end no 

earlier than April 23, 2017. Second: Under § 355(j)(5)(D), 

the exclusivity period may be forfeited in certain specified 

circumstances. According to Apotex, a court judgment of 

non-infringement would cause Mylan to forfeit the exclusivity period if Mylan has not marketed its drug 75 days 

after appeal rights are exhausted (certiorari aside) and 

Apotex has obtained tentative approval for its generic 

product from the FDA. § 355(j)(5)(D)(i)(I)(bb)(AA). If that 

is correct, and the judgment comes soon enough, Apotex 

could enter the market substantially before April 23, 2017 

(even longer before a later end of Mylan’s exclusivity 

period if Mylan delays entry past October 25, 2016); such 

entry would likely transfer sales from Daiichi and Mylan 

to Apotex and, because of the greater competition, reduce 

the price Daiichi and Mylan would charge. 

Daiichi and Mylan did not dispute that an earlierthan-otherwise Apotex entry into the market would likely 

have the identified effects, to Apotex’s benefit and 

Daiichi’s and Mylan’s detriment. But Daiichi argued that 

no controversy exists because it could not now assert the 

disclaimed ’703 patent against Apotex. Mylan added 

arguments based on the fact that Apotex lacked (and 

lacks) a “tentative approval” from the FDA for its ANDA.1 

Specifically, Mylan argued that redress of Apotex’s delayed-market-entry injury is unduly speculative before 

tentative approval is in hand. Mylan also made an argu1 Congress has defined “tentative approval” to 

mean the FDA’s determination that the ANDA has met 

the substantive requirements for obtaining generic marketing approval (by demonstrating, among other things, 

bioequivalence to the listed drug) but that final approval 

by the FDA is blocked by other barriers, such as a live 

patent, a 30-month stay caused by ongoing litigation, or 

certain exclusivity periods. § 355(j)(5)(B)(iv)(II)(dd)(AA). 

 

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APOTEX INC. v. DAIICHI SANKYO, INC. 7

ment based on the fact that tentative approval is a necessary statutory condition for the forfeiture of Mylan’s 

presumptive exclusivity period based on the declaratory 

judgment requested here. § 355(j)(5)(D). It argued that

the forfeiture provision should be read to mean that, for a 

declaratory judgment brought by a second ANDA filer to 

cause forfeiture, the second ANDA filer must have had 

tentative FDA approval when it brought the declaratoryjudgment action. Under that interpretation, Mylan 

contended, the present action cannot provide Apotex 

forfeiture relief—even if Apotex could file an identical 

declaratory-judgment action as soon as it obtains tentative approval. 

The district court granted Daiichi’s motion. It reasoned that “both Daiichi and Apotex no longer hold any 

meaningful interest in the now disclaimed patent” and 

that the FDA’s continuing to list the ’703 patent in the 

Orange Book “does not create a case or controversy by 

which Apotex may seek a declaratory judgment regarding 

a nonexistent patent.” Apotex, Inc. v. Daiichi Sankyo, 

Inc., No. 12-CV-9295, 2014 WL 114127, at *4 (N.D. Ill. 

Jan. 9, 2014). The court denied Mylan’s motion to intervene as moot in light of its grant of Daiichi’s dismissal 

motion. Id. 

Apotex appeals, and Mylan cross-appeals the denial of 

its motion to intervene. We have jurisdiction under 28 

U.S.C. § 1295(a)(1).

DISCUSSION

We review de novo a district court’s dismissal of a declaratory-judgment action for lack of subject-matter 

jurisdiction. Sandoz Inc. v. Amgen Inc., 773 F.3d 1274, 

1277 (Fed. Cir. 2014). Where, as here, no timeliness issue 

is present, we review denial of intervention as of right de 

novo. See Stauffer v. Brooks Bros., Inc., 619 F.3d 1321, 

1328 (Fed. Cir. 2010) (denial of intervention reviewed 

under regional circuit’s law); Sokaogon Chippewa Cmty. v. 

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8 APOTEX INC. v. DAIICHI SANKYO, INC. 

Babbitt, 214 F.3d 941, 945 (7th Cir. 2000) (de novo review 

of denial of motion to intervene). 

A 

We begin by confirming Mylan’s right to be a party in 

this case because of its obvious stake in the dispute. Rule 

24(a) of the Federal Rules of Civil Procedure establishes a 

right to intervene when a person “claims an interest 

relating to the property or transaction that is the subject 

of the action, and is so situated that disposing of the 

action may as a practical matter impair or impede the 

movant’s ability to protect its interest, unless existing 

parties adequately represent that interest.” Mylan readily meets that standard.

In this action, Apotex seeks to cause a forfeiture of 

Mylan’s presumed market-exclusivity period, and Mylan 

has a concrete monetary interest in retaining such exclusivity—six months of more sales and/or higher prices than 

are likely when Apotex enters the market. Although 

Daiichi likely benefits from the 180-day exclusivity period 

as well, Mylan’s interest exists apart from that of Daiichi, 

which, as a rival of Mylan’s, has its own incentives affecting decisions about how to conduct this litigation. Keith v. 

Daley, 764 F.2d 1265, 1268 (7th Cir. 1985) (interest must 

“belong[] to the proposed intervenor rather than to an 

existing party in the suit”). Mylan’s interest here is “ ‘of 

such a direct and immediate character that [Mylan] will 

either gain or lose by the direct legal operation and effect 

of the judgment’ ” sought by Apotex. Am. Mar. Transp., 

Inc. v. United States, 870 F.2d 1559, 1561 (Fed. Cir. 1989)

(emphases removed) (quoting United States v. AT&T Co., 

642 F.2d 1285, 1292 (D.C. Cir. 1980)). And Apotex does 

not defend the district court’s conclusion that Mylan’s 

interest in the case was rendered moot by the dismissal of 

the case, where, as here, Apotex is seeking to reverse the 

dismissal. Mylan has a strong, concrete interest in deCase: 14-1282 Document: 82-2 Page: 8 Filed: 03/31/2015
APOTEX INC. v. DAIICHI SANKYO, INC. 9

fending the dismissal on this appeal. Accordingly, we 

reverse the denial of Mylan’s motion to intervene. 

B 

We also reverse the district court’s dismissal of Apotex’s complaint for lack of a case or controversy. The 

stakes over which the parties are vigorously fighting are 

concrete and substantial: the amount of revenue there 

will be from sales of olmesartan medoxomil, and who will 

get what portions of it, during a period of at least six 

months. We conclude that “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.” MedImmune, Inc. v. 

Genentech, Inc., 549 U.S. 118, 127 (2007) (internal quotation marks and citation omitted). 

The case-or-controversy analysis, as relevant here, 

has borrowed from decisions on standing and ripeness. 

See Sandoz, 773 F.3d at 1277–78; Prasco, LLC v. Medicis 

Pharm. Corp., 537 F.3d 1329, 1335–36 (Fed. Cir. 2008). 

“Standing under Article III of the Constitution requires 

that an injury be concrete, particularized, and actual or 

imminent; fairly traceable to the challenged action; and 

redressable by a favorable ruling.” Monsanto Co. v. 

Geertson Seed Farms, 561 U.S. 139, 149 (2010). Where, 

as here, no further facts are needed for the requested 

adjudication (non-infringement is beyond dispute, given 

the disclaimer), ripeness depends on any harm to the 

plaintiff from delaying adjudication and the degree of 

uncertainty about whether an adjudication will be needed. Sandoz, 773 F.3d at 1277–78. In this case, these 

overlapping formulations have led the parties to focus on 

(1) whether Daiichi’s disclaimer of the patent means that 

the parties lack concrete stakes in the dispute over the 

declaratory judgment; (2) whether the alleged harm is 

traceable to Daiichi; (3) whether the real-world impact is 

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10 APOTEX INC. v. DAIICHI SANKYO, INC. 

too contingent on future events—specifically, FDA tentative approval of Apotex’s ANDA; and (4) whether Apotex’s 

alleged harm would not be redressed even if Apotex 

receives the requested judgment because ultimate relief is 

independently blocked by the statutory standards for 

triggering forfeiture of Mylan’s exclusivity period. We 

address those issues in turn. 

1 

We first reject Daiichi’s contention, adopted by the 

district court, that Daiichi’s statutory disclaimer of the 

’703 patent itself means that there is no adversity between it and Apotex over stakes of a concrete character. 

See Hollingsworth v. Perry, 133 S. Ct. 2652, 2662 (2013) 

(“To have standing, a litigant . . . must possess a ‘direct 

stake in the outcome’ of the case.”) (quoting Arizonans for 

Official English v. Arizona, 520 U.S. 43, 64 (1997)); Warth 

v. Seldin, 422 U.S. 490, 498–99 (1975). The concrete 

stakes over which Daiichi and Apotex are fighting are the 

revenues to be earned through selling olmesartan medoxomil. The patent disclaimer eliminates one, but only one,

potential legal barrier to Apotex’s ability to make such 

sales sooner rather than later. The listing of the patent, 

with its current consequence of preventing FDA approval 

during Mylan’s presumptive exclusivity period, is another, 

and the parties have adverse concrete interests in the 

truncation or preservation of that period.

Apotex, Daiichi, and Mylan are all likely affected, 

though not in perfect mirror-image ways, by whether 

Apotex can cause the forfeiture of Mylan’s exclusivity 

period. Until that period ends, Apotex cannot make sales, 

and delay of entry may have lingering adverse effects on 

market share. See Teva Pharm., USA, Inc. v. FDA, 182 

F.3d 1003, 1011 n.8 (D.C. Cir. 1999) (second-filing generic 

manufacturers “face continued harm because of their 

denied access to the market . . . , harm potentially heightened because of [the first filer’s] period of market exclusivCase: 14-1282 Document: 82-2 Page: 10 Filed: 03/31/2015
APOTEX INC. v. DAIICHI SANKYO, INC. 11

ity”). Once Apotex enters, Daiichi and Mylan can expect 

to lose sales they otherwise would have made. It is plausible, too, that entry by Apotex would produce prices 

noticeably lower than those Daiichi and Mylan would 

charge during a duopoly period (with Mylan the exclusive 

generic seller).2 Daiichi and Mylan will thereby be 

harmed by Apotex’s entry (even if the lowered prices 

benefit consumers as much as or more than Apotex). 

In these circumstances, by any common-sense measure, the parties have substantial, concrete stakes in 

whether Apotex secures the non-infringement judgment it 

seeks to advance its entry into the market. If the judgment issues, there is every likelihood that Daiichi and 

Mylan will lose substantial revenues, and Apotex will 

gain substantial revenues. This case is quite different 

from cases in which a case or controversy has been held 

missing because the plaintiffs had mere generalized or 

bystander interests in others’ compliance with law. 

Of course, other requirements for a case or controversy have to be met: most significantly, the desired advancing of FDA approval and of Apotex’s market entry must 

not be too speculative a consequence of the requested non2 See FDA, Center for Drug Evaluation and Research, 

Generic Competition and Drug Prices (last updated Mar. 

1, 2010), www.fda.gov/AboutFDA/CentersOffices/Officeof 

MedicalProductsandTobacco/CDER/ucm129385.htm (“On 

average, the first generic competitor prices its product 

only slightly lower than the brand-name manufacturer. 

However, the appearance of a second generic manufacturer reduces the average generic price to nearly half the 

brand name price.”); Teva Pharm. USA, Inc. v. Pfizer 

Inc., 405 F.3d 990, 993 (Fed. Cir. 2005) (Gajarsa, J.) 

(dissenting from denial of rehearing en banc) (exclusivity 

period creates a “comfortable duopoly” for the NDA holder 

and the first ANDA filer).

 

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12 APOTEX INC. v. DAIICHI SANKYO, INC. 

infringement judgment. Lujan v. Defenders of Wildlife, 

504 U.S. 555, 560–61 (1992). And Daiichi and Mylan 

argue that the advancing of approval and entry actually 

cannot follow because, under the governing statutory 

provisions, the present Apotex lawsuit cannot strip them 

of what they say is their legal entitlement to hold onto the 

benefits of delaying Apotex’s entry. We discuss those 

questions infra. But Daiichi is wrong in its threshold 

argument that its disclaimer of the ’703 patent itself 

eliminates a case or controversy.

2 

Daiichi is also wrong to the extent it contends that the 

delayed entry of Apotex at issue here is not “fairly traceable” to Daiichi. Allen v. Wright, 468 U.S. 737, 751 (1984). 

If Daiichi had not listed the ’703 patent in the Orange 

Book in the first place, the ’599 patent would be the only 

listed patent, and Mylan undisputedly would have no 

exclusivity period at present, because it lost its challenge 

to the ’599 patent. Since 2003, the statute has expressly 

conditioned a first filer’s eligibility for marketing exclusivity on its ability to “lawfully maintain[ ]” a Paragraph IV 

certification. 21 U.S.C. § 355(j)(5)(B)(iv)(II)(bb). Where, 

as here, a first ANDA filer lists a patent in a paragraph 

IV certification and loses in litigation through a judgment 

that confirms infringement and rejects invalidity, that 

applicant may no longer lawfully maintain its paragraph 

IV certification.3 Thus, Mylan would currently not be 

3 FDA regulations provide that “[a]n applicant who 

has submitted a [paragraph IV certification] and is sued 

for patent infringement . . . shall amend the certification 

if a final judgment . . . is entered finding the patent to be 

infringed. In the amended certification, the applicant 

shall certify under paragraph [III] that the patent will 

expire on a specific date. Once an amendment or letter 

for the change has been submitted, the application will no 

 

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eligible for an exclusivity period had Daiichi never listed 

the ’703 patent. Oral Argument at 2:30–46 (Apotex), 

Apotex Inc. v. Daiichi Sankyo, Inc., No. 2014-1282, -1291; 

id. at 16:50–17:10 (Daiichi). It is only Daiichi’s original 

listing of that patent—which Daiichi has disclaimed—

that now supports Mylan’s exclusivity period, which 

Apotex filed this action to bring to an end. 

Daiichi is therefore responsible for the current existence of Mylan’s exclusivity-period rights. Importantly, by 

so stating, we are not asserting that such responsibility is 

a necessary condition for the case or controversy here. We 

do not decide, and do not have to decide, whether it would 

be enough, for a justiciable dispute, that a requested 

judgment of non-infringement would lead the FDA to 

allow a market entry that would have concrete revenuetransferring effects on all parties. In this case, Daiichi’s 

act of listing the ’703 patent in the Orange Book created 

the entry barrier that Apotex, through a declaratory 

judgment, seeks to eliminate.

Relatedly, for case-or-controversy purposes, it is immaterial whether Daiichi acted contrary to the statutory 

standard in listing the ’703 patent in the Orange Book—

which we do not know, one way or the other. Daiichi is 

causally responsible for the current existence of the 

exclusivity period; Apotex seeks a judgment of nonlonger be considered to be one containing a [Paragraph IV 

certification].” 21 C.F.R. § 314.94(a)(12)(viii)(A) (2015). 

The required application amendment causes the first filer 

to forfeit its eligibility for any market exclusivity based on 

that certification. 21 U.S.C. § 355(j)(5)(D)(i)(III); see 

Letter from G. Buehler, Director, Office of Generic Drugs, 

to ANDA Applicant regarding 180-day exclusivity for 

dorzolamide/timolol ophthalmic solution, Docket No. 

FDA-2008-N-0483-0017 at 5–6 (Oct. 28, 2008), available 

at www.regulations.gov (Dorzolamide/Timolol Letter).

 

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14 APOTEX INC. v. DAIICHI SANKYO, INC. 

infringement that does not depend on whether the original listing was proper; and there has been no suggestion 

that, under the statute, the forfeiture of the exclusivity 

period depends on the original listing’s propriety. Neither 

the logic nor precedents controlling the Article III determination would make the entry of the requested judgment 

in these circumstances something other than the resolution of a case or controversy—as long as it is “likely, as 

opposed to merely speculative,” that the consequence 

would be the concrete one of advancing the date of approval by the FDA and market entry by Apotex. Lujan, 

504 U.S. at 560–61 (internal quotation marks omitted). 

We turn to that critical question.

3 

One aspect of that question is whether, putting aside 

the statutory provisions governing the exclusivity period, 

tentative FDA approval for Apotex’s proposed drug is a 

prerequisite for a case or controversy here. Specifically,

exclusivity-period provisions aside, is the prospect of 

concrete relief for Apotex too uncertain to support an 

adjudication of the request for a non-infringement judgment until Apotex obtains tentative approval? We conclude that the answer is no.

The general principle governing the inquiry, including 

in situations where ultimate relief from harm depends on 

the action of a third party (here, the FDA’s approval of the 

ANDA to allow marketing), is whether there is too high a 

degree of uncertainty about whether the judicial resolution, if in the plaintiff’s favor, will matter in alleviating 

the harm alleged by the plaintiff. See Lujan, 504 U.S. at 

560–61 (likely, as opposed to speculative); Warth, 422 

U.S. at 504, 507 (“substantial probability,” not “remote 

possibility”); Linda R.S. v. Richard D., 410 U.S. 614, 618 

(1973) (not too “speculative”). That context-dependent 

standard has been applied to allow adjudication to remove 

one legal barrier to the plaintiff’s obtaining the concrete 

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APOTEX INC. v. DAIICHI SANKYO, INC. 15

alleviation of harm it seeks, notwithstanding potential 

independent barriers to achieving that result, as long as 

such other potential barriers are not unduly likely to 

deprive the adjudication of concrete effect. Thus, in

Arlington Heights v. Metropolitan Housing Development

Corp., 429 U.S. 252 (1977), the Court found that a developer and a would-be resident had standing to challenge a 

zoning scheme that stood “as an absolute barrier to constructing the housing” the developer sought to build, 

stating: “If [the developer] secures the injunctive relief it 

seeks, that barrier will be removed.” Id. at 261. Other 

barriers that might doom actual development, such as 

inability to obtain financing, though real, were not so 

certain as to bar standing to obtain removal of the barrier 

at issue, id. at 261 & n.7, because there was a “substantial probability” that the “project w[ould] materialize” if 

the adjudication occurred, id. at 264. As a result, the 

injuries to the developer and would-be resident were 

“ ‘likely to be redressed by a favorable decision.’ ” Id. at 

262 (quoting Simon v. Eastern Ky. Welfare Rights Org., 

426 U.S. 26, 38 (1976)); id. at 264. 

Because the likelihood of ultimate alleviation of harm 

involves a judgment call about a causal chain, congressional action is relevant. The Supreme Court and our 

court have recognized the potential significance of congressional action in “articulat[ing] chains of causation 

that will give rise to a case or controversy where none 

existed before.” Massachusetts v. EPA, 549 U.S. 497, 516 

(2007); see Consumer Watchdog v. Wis. Alumni Research 

Found., 753 F.3d 1258, 1261 (Fed. Cir. 2014). By deeming 

certain series of links from conduct to harm or from 

judgment to alleviation of harm not to be unduly speculative, Congress may “effectively creat[e] justiciability that 

attenuation concerns would otherwise preclude.” Sandoz, 

773 F.3d at 1281. 

In the present context, the congressional judgment

embodied in the “Hatch-Waxman Amendments” to the 

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16 APOTEX INC. v. DAIICHI SANKYO, INC. 

Food, Drug, and Cosmetic Act,4 as consistently implemented in our case law, makes clear that tentative approval for Apotex is not a precondition to adjudicating the 

patent issue. When a generic manufacturer seeks to enter 

the market, the concrete stakes are the market sales upon 

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

527 F.3d 1278, 1292 (Fed. Cir. 2008) (“exclud[ing] noninfringing generic drugs from the market . . . is a sufficient Article III injury-in-fact”). Yet Congress, in 35 

U.S.C. § 271(e)(2), defined an “artificial act of infringement,” Eli Lilly & Co. v. Medtronic, Inc., 496 U.S. 661, 

678 (1990), that allows litigation to take place well before 

any product is actually placed on the market and before 

any FDA regulatory approval, the litigation serving to 

remove one barrier to such approval and marketing. See 

Glaxo, Inc. v. Novopharm, Ltd., 110 F.3d 1562, 1569 (Fed. 

Cir. 1997) (under Hatch-Waxman, the focus of infringement litigation is on “what the ANDA applicant will likely

market if its application is approved, an act that has not 

yet occurred”) (emphases added); cf. Amgen Inc. v. Int’l 

Trade Comm’n, 565 F.3d 846, 851–52 (Fed. Cir. 2009)

(noting that the Supreme Court has “stressed the congressional purpose of removing patent-based barriers to 

proceeding with federal regulatory approval of medical 

products”).

Critically, the statute authorizing the litigation upon 

filing of an ANDA nowhere requires tentative FDA approval as a precondition: the filing of the ANDA, with a 

paragraph IV certification, is itself deemed an act of 

infringement. 35 U.S.C. § 271(e)(2); see Caraco Pharm. 

Labs., Ltd. v. Novo Nordisk A/S, 132 S. Ct. 1670, 1677 

4 Drug and Price Competition and Patent Term 

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

(codified at 21 U.S.C. § 355, 28 U.S.C. § 2201, and 35 

U.S.C. §§ 156, 271, & 282).

 

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(2012) (“The patent statute treats such a filing as itself an 

act of infringement, which gives the brand an immediate 

right to sue.”). Moreover, Congress required the ANDA 

filer to provide prompt notice to the relevant patent 

owners (and NDA holder), 21 U.S.C. § 355(j)(2)(B), and for 

the patent owners to bring suit within 45 days to obtain a 

30-month delay in any effective date of approval for the 

ANDA, § 355(j)(5)(B)(iii). It is undisputed that it would 

be rare for tentative approval to have occurred 45 days 

into the ANDA process. See also § 355(j)(5)(D)(i)(IV) 

(provision triggering forfeiture based on first filer’s failure 

to obtain tentative approval, presumptively giving first 

filer a full 30 months to obtain tentative approval). The 

statute evidently contemplates litigation well before such 

tentative approval. 

Our decisions reflect that fact. In all of our cases involving litigation over ANDA applications, we have never 

required tentative approval, including in suits brought 

almost immediately after the ANDA’s filing. See, e.g.,

Caraco, 527 F.3d at 1295 (“Caraco has a complete generic 

drug product that has been submitted to the FDA for 

approval, and no additional facts are required to determine whether this drug product infringes the claims of 

Forest’s ’941 patent.”); Teva Pharm. USA, Inc. v. Novartis 

Pharm. Corp., 482 F.3d 1330, 1342 (Fed. Cir. 2007) (because the patent owner, upon a generic’s filing of a paragraph IV certification, “would have an immediate 

justiciable controversy, . . .[i]t logically follows that . . . the 

same action should create a justiciable declaratory judgment controversy for the opposing party”).5 

5 See Pozen Inc. v. Par Pharm., Inc., 696 F.3d 1151 

(Fed. Cir. 2012); Sanofi-Aventis v. Apotex Inc., 659 F.3d 

1171 (Fed. Cir. 2011); Ortho-McNeil Pharm., Inc. v. Mylan 

Labs., Inc., 520 F.3d 1358 (Fed. Cir. 2008); SanofiSynthelabo v. Apotex, Inc., 550 F.3d 1075 (Fed. Cir. 2008); 

 

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18 APOTEX INC. v. DAIICHI SANKYO, INC. 

Accordingly, tentative approval of an ANDA is generally not a precondition to the existence of a case or controversy concerning patents listed in the Orange Book. 

Moreover, that general case-or-controversy conclusion 

does not depend on whether the patent owner or the

ANDA applicant initiates the litigation, the latter specifically authorized by Congress to bring a declaratoryjudgment action if the former does not sue. 21 U.S.C. 

§ 355(j)(5)(C). For those reasons, we conclude that tentative approval is not required for the present dispute to 

constitute a case or controversy unless there is an additional context-specific reason tied to statutory provisions 

that distinguishes this situation from those in which we 

have deemed tentative approval unnecessary to satisfy 

Article III.

4 

That conclusion brings us to the objection to justiciability based on the specific statutory provisions governing 

forfeiture of the exclusivity period. It is undisputed here 

that Mylan currently has an exclusivity period available 

to it, based on the original listing of the now-disclaimed 

’703 patent and Mylan’s continued maintenance of its 

paragraph IV certification regarding that patent. It is 

also undisputed that the only basis asserted for Apotex to 

enter earlier than the end of the exclusivity period is a 

forfeiture of the period under § 355(j)(5)(D)(ii)—

specifically, one triggered by a “forfeiture event” defined 

by § 355(j)(5)(D)(i)(I)(bb)(AA). The only arguments presented to us are arguments directly about those proviApotex, Inc. v. Thompson, 347 F.3d 1335 (Fed. Cir. 2003); 

Andrx Pharm., Inc. v. Biovail Corp., 276 F.3d 1368 (Fed. 

Cir. 2002); Minn. Mining And Mfg. Co. v. Barr Labs., Inc., 

289 F.3d 775 (Fed. Cir. 2002). See also Teva Pharm. USA, 

Inc. v. EISAI Co., 620 F.3d 1341, 1350 (Fed. Cir. 2010),

judgment vacated for mootness, 131 S. Ct. 2991 (2011).

 

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sions—specifically, whether they permit Apotex to trigger 

forfeiture by the judgment requested in this case. Daiichi 

and Mylan do not suggest that, were a non-infringement 

judgment to issue in this case, the FDA would nonetheless 

consider it inadequate to trigger forfeiture of Mylan’s 

exclusivity period based on a restrictive view of the forfeiture provisions that is entitled to judicial deference. Nor 

do they argue that any FDA approval would come too late 

to advance Apotex’s market entry in any event. We

conclude that Apotex can trigger forfeiture by obtaining 

the non-infringement judgment it seeks in this case and, 

thus, that a case or controversy exists here. 

The provisions at issue are best read with a little 

background and context. The provisions were added to 

the statute by the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA), Pub. L. No. 

108–173, § 1102, 117 Stat. 2066, 2457–60 (2003) (codified 

as amended at 21 U.S.C. § 355(j)). 

For ANDA applications filed before the December 

2003 enactment of the MMA, the statute, as this court 

read it, was more protective of a first ANDA filer’s exclusivity period than it became under the MMA. In particular, and “[s]ignificantly, the first Paragraph IV ANDA 

filer [was] entitled to the 180-day exclusivity period 

regardless of whether it establishe[d] that the Orange 

Book patents [were] invalid or not infringed by the drug 

described in its ANDA.” Janssen Pharmaceutica, N.V. v. 

Apotex, Inc., 540 F.3d 1353, 1356 (Fed. Cir. 2008); see 

Caraco, 527 F.3d at 1283; 21 U.S.C. § 355(j)(5)(B)(iii), (iv) 

(2000).6 Moreover, the pre-MMA statute contained no 

6 This court’s Janssen decision thus ruled that exclusivity was not defeated when a patent identified in a 

paragraph IV certification was held valid and infringed—

even though an FDA regulation required alteration of the 

certification to become a paragraph III certification. 21 

 

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20 APOTEX INC. v. DAIICHI SANKYO, INC. 

express requirement that the first filer lawfully maintain 

its paragraph IV certification, and it offered no express 

path for subsequent ANDA filers to eliminate a first filer’s 

exclusivity period, i.e., to trigger its forfeiture. The statute merely provided that, when a first filer had not activated its 180-day clock, a subsequent filer could do so—

even where the first filer was blocked from marketing its 

drug by a later-expiring patent—by securing a judgment 

of non-infringement or invalidity. See Janssen, 540 F.3d 

at 1357; Caraco, 527 F.3d at 1284; 21 U.S.C. 

§ 355(j)(5)(B)(iv) (2000). Notably, Janssen (like Caraco) 

was decided under the pre-MMA scheme, see 540 F.3d at 

1357 n.2, and it was under that scheme that Janssen

concluded that the second filer’s “inability to promptly 

C.F.R. § 314.94(a)(12)(viii)(A) (2003). By 2003, the FDA 

had been moving toward denying exclusivity, as a regulatory matter, in various circumstances where an initial 

paragraph IV certification lost its foundation, and the 

courts expressed different views on the FDA’s evolving 

position. See Dr. Reddy’s Labs., Inc. v. Thompson, 302 F. 

Supp. 2d 340 (D.N.J. 2003) (upholding the FDA’s denial of 

exclusivity based on pre-approval expiration of patent 

subject to paragraph IV certification); Mylan Pharm., Inc. 

v. Thompson, 207 F. Supp. 2d 476 (N.D. W. Va. 2001) 

(rejecting the FDA’s denial of exclusivity based on treating first filer’s settlement with patent owner as effectively 

changing certification); Mylan Pharm., Inc. v. Henney, 94 

F. Supp. 2d 36 (D.D.C. 2000) (rejecting the FDA’s refusal 

to interpret its regulation to deny exclusivity based on 

first filer’s agreement to change certification from paragraph IV to III), vacated and dismissed as moot sub nom. 

Pharmachemie B.V. v. Barr Labs., Inc., 276 F.3d 627 

(D.C. Cir. 2002); Mova Pharm Corp. v. Shalala, 140 F.3d 

1060, 1071 (D.C. Cir. 1998) (noting the FDA’s view that 

exclusivity is not lost upon certification change after 

adjudication of validity and infringement). 

 

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launch its generic” product “because of [the first filer’s] 

180-day exclusivity period is not a cognizable Article III 

controversy, but a result envisioned by the HatchWaxman Act.” Id. at 1361.

Section 1102 of the MMA altered the exclusivity 

scheme in two fundamental ways. First: It expressly 

conditioned the first filer’s eligibility for exclusivity on its 

“lawfully maintain[ing]” a paragraph IV certification, 

§ 355(j)(5)(B)(iv)(II)(bb). As already described, a first filer 

may not lawfully maintain an initial paragraph IV certification as to which it lost a litigation challenge regarding 

infringement and validity. See supra p. 12 & n.3. In 

other words, the exclusivity period is no longer guaranteed just for the effort of challenging a patent (its scope or 

its validity), as Janssen had said of the pre-2003 statute. 

Losing in the challenge eliminates the patent from the 

group of patents that can support an exclusivity period. 

Second: The MMA added to the statute an elaborate 

new forfeiture provision that declares that “[t]he 180-day 

exclusivity period described in [§ 355(j)(5)(B)(iv)] shall be 

forfeited by a first applicant if a forfeiture event occurs 

with respect to that first applicant.” § 355(j)(5)(D)(ii). 

The provision defines “forfeiture event,” § 355(j)(5)(D)(i),

and one group of such events is the first filer’s “failure to 

market” “by the later of” two dates. § 355(j)(5)(D)(i)(I). 

One of those dates is specified in (aa): the earlier of 75 

days after the first filer’s effective date for approval or 30 

months after the first filer submitted its application. 

§ 355(j)(5)(D)(i)(I)(aa). In the present case, because Mylan 

filed in April 2006, the 30-month date arrived in October 

2008. The second of the “later of” dates is specified in 

(bb), which is what is at issue here:7 

7 No one here disputes that the “later of” language 

applies only if one of the (bb)-specified events occurs, i.e., 

 

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22 APOTEX INC. v. DAIICHI SANKYO, INC. 

 (bb) with respect to the first applicant or any 

other applicant (which other applicant has received tentative approval), the date that is 75 days 

after the date as of which, as to each of the patents with respect to which the first applicant 

submitted and lawfully maintained a certification 

qualifying the first applicant for the 180-day exclusivity period under subparagraph (B)(iv), at 

least 1 of the following has occurred: 

 (AA) In an infringement action brought 

against that applicant with respect to the 

patent or in a declaratory judgment action

brought by that applicant with respect to 

the patent, a court enters a final decision 

from which no appeal (other than a petition to the Supreme Court for a writ of 

certiorari) has been or can be taken that 

the patent is invalid or not infringed. 

 (BB) In an infringement action or a declaratory judgment action described in 

subitem (AA), a court signs a settlement 

order or consent decree that enters a final 

judgment that includes a finding that the 

patent is invalid or not infringed.

 (CC) The patent information submitted 

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

[§ 355] is withdrawn by the holder of the 

application approved under subsection (b) 

of this section [the NDA].

 § 355(j)(5)(D)(i)(I)(bb) (emphases added). 

that the arrival of one of the (aa)-specified dates is not 

itself enough if no (bb) event has occurred. See also Teva 

v. Sebelius, 595 F.3d at 1316–17.

 

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The first step in applying that provision to the present 

case is to note that, although Mylan (the “first applicant”) 

initially made a paragraph IV certification for both the 

’599 and ’703 patents, the ’599 certification is no longer 

“lawfully maintained,” because Mylan lost its litigation 

over that patent. As a result, the only lawfully maintained certification involves the ’703 patent, and the (bb) 

standards must be applied only to that patent. As to that 

patent, then, (bb)(AA) specifies that Mylan forfeits its 

exclusivity period if it has not entered the market by the 

following date: with respect to Apotex, a second-filing 

applicant, “which other applicant has received tentative 

approval,” 75 days after what we may, for convenience, 

call the “non-infringement finality date”—more precisely, 

when the appeal time ends without an appeal after the 

district court enters a non-infringement judgment, see 28 

U.S.C. § 2107(a) (30-day period); Fed. R. App. P. 4, or 

when this court enters its judgment affirming the noninfringement judgment if there has been an appeal. 

 This provision, which separates the tentativeapproval phrase from its specification of certain forfeiture-triggering dates, including the non-infringementfinality date of (AA), admits of a simple reading. There 

are two requirements for forfeiture: a court must have 

entered a final decision of non-infringement that is no 

longer appealable (certiorari aside), and the second (or 

later) filer must have received tentative approval. The 

first filer forfeits its exclusivity if it has not entered 75 

days after those two requirements are satisfied. Under 

that reading, Apotex can trigger forfeiture in this case by 

obtaining the judgment it seeks here and by obtaining

tentative approval, if it does both early enough in relation 

to Mylan’s market entry.

Mylan argues for a different interpretation of the 

statute—that the second filer (the “other applicant” in 

(bb)) must have tentative approval before it initiates the 

declaratory-judgment action. Mylan Br. 5, 21–22. Mylan 

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24 APOTEX INC. v. DAIICHI SANKYO, INC. 

contends that the text of (bb) and (AA) taken together 

unambiguously mandates that tentative approval is a 

prerequisite for entry into court if the action is ultimately 

to have a forfeiture effect. We reject that reading of the 

provision. 

The statutory text does not compel Mylan’s interpretation. The provision’s language, standing alone, leaves 

ambiguous the time at which the “received tentative 

approval” requirement must be met—at the institution of 

the declaratory-judgment action or at some later time. 

We must therefore look to the statutory context and 

policy. That analysis points convincingly against Mylan’s 

view. 

The textual contrast with another relevant provision 

added to the statute by the MMA, namely, § 355(j)(5)(C)—

under which Apotex filed its declaratory-judgment action—confirms the facial ambiguity of the (bb)(AA) language at issue and reinforces our interpretation that 

tentative approval is not required at the outset of the 

action. Section 355(j)(5)(C) imposes clear preconditions on 

an ANDA filer’s bringing of a declaratory-judgment action 

against the patent owner: “No action may be brought 

under [the Declaratory Judgment Act] . . . unless” the 

patent owner declines to sue the ANDA applicant 45 days 

after it gives notice of filing a paragraph IV certification. 

Id. (emphasis added); see 35 U.S.C. § 271(e)(5). No such 

initiation-focused mandatory language is found in the 

forfeiture provision at issue here. The contrast is significant.

Indeed, it would be surprising to find an entry-intocourt prerequisite in the forfeiture provision, given how 

the forfeiture provision is plainly intended to operate. 

The only role to be played by the declaratory-judgment 

action referred to in § 355(j)(5)(D)(i)(I)(bb)(AA) is a role 

played at the end of the action—a “final decision” in the 

defined sense of completing as-of-right appeals—namely, 

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forfeiture no earlier than 75 days after that event. The 

provision does not give the mere filing of the action any 

effect. It makes no sense, where not compelled by the text 

or context, to give the provision an interpretation extraneous to its evident function.

Moreover, Mylan’s view that tentative approval is required for a second filer to be “that applicant” under (AA) 

would, for all we can tell, have to apply even when, as 

(AA) expressly contemplates, the patent owner brings “an 

infringement action . . . against that applicant.” For 

reasons we have noted, such as preventing immediate 

approval of an ANDA and triggering a 30-month delay in 

the effectiveness of any approval, § 355(j)(5)(B)(iii), it is 

commonplace and expected that the patent owner will 

bring an infringement action under 35 U.S.C. § 271(e)(2) 

within 45 days of receiving notice of the ANDA, well 

before any tentative approval. It appears that, under 

Mylan’s “that applicant” view, such a suit, even when the 

second filer wins, would fall outside the (AA) provision at 

issue here and thus not have any forfeiture effect. Mylan 

has not shown us why that result is a sensible one. 

Indeed, in that instance, where the second filer has been 

responsible for winning a contested invalidity or noninfringement ruling, it would be the second filer that 

conferred the public benefit that Mylan has touted before 

us: clearing the particular patent from the field of potential competition.

Not only does it make no sense to read the forfeiture 

provision as requiring tentative approval at the outset of 

the second filer’s declaratory-judgment action. It makes 

good sense to read the provision as providing for forfeiture 

simply when there has been no entry 75 days after the

non-infringement finality date and the date of tentative 

approval. That reading serves the evident congressional 

policy of triggering forfeiture when a second filer is ready 

to launch. See 149 Cong. Rec. 31,200 (2003) (statement of 

Sen. Schumer) (“If it forfeits, then the exclusivity is lost 

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26 APOTEX INC. v. DAIICHI SANKYO, INC. 

and any other generic applicant that is ready to be approved and go to market can go.”). 

Tentative approval is required before a second filer 

can actually trigger forfeiture, because exclusivity should 

not be lost unless the second filer is on the verge of having 

an approved product to deliver the benefits of competition. 

It would be arbitrary, in terms of the discernible policy, to 

require tentative approval earlier. Thus, for this case, the 

purpose of requiring tentative approval has nothing to do 

with Apotex’s approval status at the time it brought the 

declaratory-judgment action, and it has everything to do 

with its approval status when forfeiture is triggered. Our 

interpretation—the 75-day clock for Mylan starts to run 

when Apotex has both tentative approval and a no-longerappealable judgment of non-infringement—fits the concrete function of the provision, whereas Mylan’s does not. 

Mylan argues that its view is required by the statutory policy underlying the exclusivity period. But its argument is too detached from the particulars of the statute. 

The exclusivity period, § 355(j)(5)(B)(iv), rests on a balancing of interests: encouraging early entry by generics into 

the market by providing a reward to first filers (substantially higher prices for a time and a first-mover advantage, see Mova Pharm. Corp. v. Shalala, 140 F.3d 

1060, 1066 n.6 (D.C. Cir. 1998)), but only up to a point (as

that reward creates higher prices for consumers, see Teva, 

595 F.3d at 1318). There is no a priori right balance. We 

must look to what Congress enacted—specifically, the 

MMA provisions that reset the statutory balance. See 

Teva Pharm. Indus. Ltd. v. Crawford, 410 F.3d 51, 54 

(D.C. Cir. 2005) (“Because the balance struck between 

these competing goals is quintessentially a matter for 

legislative judgment, the court must attend closely to the 

terms in which the Congress expressed that judgment.”). 

Here, as we have explained, when Mylan lost its case 

regarding the ’599 patent, it lost its right to invoke that 

patent to support an exclusivity period. And there is no 

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evident “policy” supporting maintenance of that period 

based on the ’703 patent once (it is 75 days after) Apotex 

secures a no-longer-appealable judgment of noninfringement, no matter how quick and easy the litigation, and has tentative approval, whenever that occurs. 

The decision by the D.C. Circuit in Teva v. Sebelius is 

not contrary to our interpretation of “tentative approval” 

and its role in (bb)(AA). 595 F.3d at 1317–18. That case 

addressed whether an NDA holder’s unilateral request to 

the FDA to delist a patent, if granted by the FDA, could 

terminate a first filer’s eligibility for exclusivity under 

subparagraph (CC) of § 355(j)(5)(D)(i)(I)(bb)—without any 

judicial involvement, and indeed without a disclaimer of 

the patent. 595 F.3d at 1315. The court read the language of (CC), which provides for forfeiture upon the 

“withdrawal” of an Orange Book listing by the NDA 

holder, as of a piece with subparagraphs (AA) and (BB), 

which specify judicial actions as prerequisites for the 

causing of a “failure to market” forfeiture. Id. at 1317–18. 

So read, the Teva court held, (CC) did not authorize 

forfeiture of the exclusivity period by unilateral action of 

the NDA holder (even with FDA ratification) without 

judicial involvement. In the present case, in contrast, the 

forfeiture Apotex seeks to produce is not to be effected by 

Daiichi’s unilateral action but by a court judgment.

The Teva rationale does not carry over to curtail the 

forfeiture effects prescribed by (AA) and (BB), which 

require judicial involvement and which were not invoked 

as forfeiture bases in Teva. The D.C. Circuit in Teva did 

not say that forfeiture is rendered unavailable, even with 

judicial involvement, just because the NDA holder/patent 

owner has agreed to non-infringement. Indeed, (BB) 

expressly provides for forfeiture based on a “settlement 

order or consent decree” signed by a court where the 

judgment includes a non-infringement or invalidity finding. As a statutory matter, the judicial role is key in 

distinguishing two situations, both of which may involve 

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28 APOTEX INC. v. DAIICHI SANKYO, INC. 

an NDA holder/patent owner that has given up on one of 

its patents. 

CONCLUSION

For the foregoing reasons, we hold that Apotex has alleged facts supporting the conclusion “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.” 

MedImmune, 549 U.S. at 127 (internal quotation marks 

and citation omitted). We reverse the judgment of the 

district court dismissing the case, as well as the denial of 

Mylan’s motion to intervene. 

REVERSED

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