Source: s3://data.kl3m.ai/documents/govinfo/USCOURTS/USCOURTS-caDC-09-05281/USCOURTS-caDC-09-05281-0/pdf.json

Nature of Suit Code: 890
Nature of Suit: Other Statutory Actions
Cause of Action: 

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United States Court of Appeals 

FOR THE DISTRICT OF COLUMBIA CIRCUIT

Argued December 7, 2009 Decided March 2, 2010 

No. 09-5281 

TEVA PHARMACEUTICALS USA, INC., 

APPELLANT

v. 

KATHLEEN SEBELIUS, IN HER OFFICIAL CAPACITY AS 

SECRETARY OF HEALTH AND HUMAN SERVICES, ET AL., 

APPELLEES

Consolidated with 09-5308 

Appeals from the United States District Court 

for the District of Columbia 

(No. 1:09-cv-01111-RMC) 

Michael D. Shumsky argued the cause for appellant. With 

him on the briefs were Jay P. Lefkowitz and Gregory L. 

Skidmore. 

Carmen M. Shepard and Kate C. Beardsley were on the 

briefs for cross-appellant Apotex, Inc. in No. 09-5308.

 Drake Cutini, Attorney, U.S. Department of Justice, 

argued the cause for appellees. With him on the brief were 

USCA Case #09-5281 Document #1232766 Filed: 03/02/2010 Page 1 of 35
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Eugene M. Thirolf Jr., Director, David S. Cade, Acting 

General Counsel, United States Food and Drug 

Administration, Michael M. Landa, Acting Associate General 

Counsel, and Eric M. Blumberg, Deputy Chief Counsel. 

Carmen M. Shepard and Kate C. Beardsley were on the 

brief for amicus curiae Apotex, Inc. in support of appellees. 

Before: HENDERSON and GRIFFITH, Circuit Judges, and 

WILLIAMS, Senior Circuit Judge. 

Opinion for the Court filed by Senior Circuit Judge

WILLIAMS. 

Dissenting opinion filed by Circuit Judge HENDERSON. 

WILLIAMS, Senior Circuit Judge: This is the latest 

installment in a long-running series of cases concerning an 

incentive that Congress established for companies to bring 

“generic” versions of branded drugs to market faster than they 

otherwise might. Teva Pharmaceuticals USA, Inc., a 

manufacturer of generics, has received tentative approval 

from the U.S. Food and Drug Administration to sell losartan 

potassium products—used primarily to treat hypertension. 

The approval will become final once the “pediatric exclusivity 

period”1

 ends, following the expiration of the last remaining 

patent on Merck’s pioneered versions of the same drugs, sold 

under the names Cozaar and Hyzaar. When that date arrives 

(April 6, 2010), Teva believes that it should be entitled to the 

six-month period of marketing exclusivity that generic drug 

makers earn, in some circumstances, for successfully taking 

 

1

 This is a six-month extension of the time during which all 

generic competition against a branded drug is prohibited, see 21 

U.S.C. § 355a; it is not a subject of dispute here. 

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the risks and bearing the costs of showing the invalidity or 

inefficacy of a patent that a brand-name drug maker has said 

blocks competing products. See Mova Pharmaceutical Corp. 

v. Shalala, 140 F.3d 1060, 1063-65 (D.C. Cir. 1998) 

(describing the incentive regime established by the HatchWaxman Act of 1984); Ranbaxy Laboratories Ltd. v. Leavitt, 

469 F.3d 120, 121-22 (D.C. Cir. 2006). 

Thwarting its receipt of that entitlement, however, is an 

FDA interpretation of the operative statutory regime (the 

Food, Drug, and Cosmetic Act, as amended by various other 

laws, codified in relevant part at 21 U.S.C. § 355) that will 

allow not only Teva but all generic manufacturers to sell their

approved losartan potassium products right out of the gate. In 

short, Teva says that, effective April 6, 2010, the agency’s 

interpretation will deprive the company of the competitive 

advantage Congress has said it should enjoy. 

To ward off this danger, Teva filed suit in the federal 

district court for the District of Columbia in June 2009, 

seeking a declaration that the relevant FDA policy is unlawful 

and an injunction compelling the agency to act in accordance 

with Teva’s reading of the statute. Despite protestations by 

the government that the matter was not ripe for review and 

that Teva lacked standing, the district court reached the merits 

of the claim—but ruled in the FDA’s favor. Teva 

Pharmaceuticals U.S.A, Inc. v. Sebelius, 638 F.Supp.2d 42 

(D.D.C. 2009). Teva now appeals that decision. We agree 

that the suit is justiciable, and hold that the FDA’s 

interpretation is inconsistent with, and thus foreclosed by, the 

statutory scheme. 

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* * * 

In the process of obtaining FDA approval to sell a 

pioneering new drug, an applicant lists publicly all of the 

patents that, it believes, would be infringed by 

“bioequivalent” versions of the product sold by other 

companies. Ranbaxy, 469 F.3d at 121-22 (discussing 21 

U.S.C. § 355(a)-(b)(1)). Prospective generic competitors need 

not, however, take these lists as gospel. After a new drug hits 

the market, they can effectively challenge the brand maker’s 

pronouncement by filing a certification that a proposed 

generic version of the brand drug would not run afoul of one 

(or more) of the putatively blocking patents, either because 

the patent is invalid or because the generic maker has found a 

way to design around it. See id. at 122 (discussing 21 U.S.C. 

§ 355(j)(2)(A)(vii)(IV)). The generic producer’s filing, called 

a “paragraph IV certification” in our past cases, comes in the 

course of the generic’s own application for FDA approval, 

known as an Abbreviated New Drug Application, or ANDA. 

See id. (discussing 21 U.S.C. § 355(j)(2)). 

Filing a paragraph IV certification comes with a risk, 

though: it constitutes an act of patent infringement, 35 U.S.C. 

§ 271(e)(2)(A), with the hazard of sparking costly litigation. 

In order, then, to “compensate [generic] manufacturers for 

research and development costs as well as the risk of litigation 

from patent holders,” Teva Pharmaceuticals USA, Inc. v. 

Leavitt, 548 F.3d 103, 104 (D.C. Cir. 2008), the statute 

provides that the first company to file an ANDA containing a 

paragraph IV certification earns an “exclusivity” period of 

180 days, during which the FDA may not approve for sale any 

competing generic version of the drug at issue, id. (discussing 

21 U.S.C. § 355(j)(5)(B)(iv)). This promise of initial 

marketing exclusivity is thus intended to increase competition 

by expediting the availability of generic equivalents. See id.; 

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Serono Laboratories, Inc. v. Shalala, 158 F.3d 1313, 1326 

(D.C. Cir. 1998). 

A potential bug in the system is the ability of the brand 

manufacturer, after a generic has filed a paragraph IV 

certification, to announce that in fact the challenged patent is 

not one that protects the drug at issue and to ask the FDA to 

“delist” the patent, thus purporting to pull the rug from under 

the paragraph IV certification. In Ranbaxy we considered 

“whether the FDA may delist a patent upon the request of the 

[brand manufacturer] after a generic manufacturer has filed an 

ANDA containing a paragraph IV certification so that the 

effect of delisting is to deprive the applicant of a period of 

marketing exclusivity.” 469 F.3d at 125. The answer, we 

said, was no; an FDA policy that allowed brand manufacturers 

to strategically delist challenged patents, thereby unilaterally 

stripping generic manufacturers of marketing exclusivity, was 

“inconsistent with the structure of the statute.” Id. 

Ranbaxy, however, interpreted the law as it stood before 

Congress amended it in 2003 via the Medicare Prescription 

Drug, Improvement, and Modernization Act, Pub. L. No. 108-

173, 117 Stat. 2066. Id. at 122 n.*. Three times since the 

effective date of the amendments, the same series of events at 

issue in Ranbaxy has arisen—once involving the generic 

manufacturer Cobalt Pharmaceuticals and the brand drug 

Precose, made by Bayer; once involving the generic 

manufacturer Hi-Tech Pharmacal Co. and the brand drug 

COSOPT, made by Merck; and now involving Teva, the drugs 

Cozaar and Hyzaar, and Merck. In the first two instances, the 

generic makers presented arguments to the FDA why they 

should still, in the modified statutory regime, be entitled to 

exclusivity notwithstanding the brand companies’ delisting a 

challenged patent. Teva itself responded to the FDA’s 

solicitation of comments in the Cobalt matter, advocating the 

same pro-exclusivity reading of the amended statute’s 

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treatment of post-paragraph-IV-filing delisting requests. See 

Letter from Marc Goshko, Executive Director, Teva North 

America, In Response to FDA Request for Comments re 

Generic Drug Applications for Acarbose Tablets (Oct. 16, 

2007), in Joint Appendix (“J.A.”) 78 et seq. In both cases, the 

FDA ruled that the 2003 amendments required a different 

outcome from the one Ranbaxy ordered under the old version 

of the law. 

The agency pointed to the 2003 amendments’ addition of 

a critical new term to the statute: the “forfeiture event.” See 

21 U.S.C. § 355(j)(5)(D)(ii). On the occurrence of any one of 

six defined scenarios, the law now says, the entitlement to a 

180-day exclusivity period “shall be forfeited by a first 

applicant.” See id. In both the Cobalt and Hi-Tech disputes, 

the FDA decided that the facts at issue, paralleling those in 

Ranbaxy and our case, had satisfied the terms of the first listed 

forfeiture event, “failure to market,” and in each case denied 

the generic manufacturer exclusivity. 

The statutory definition of the first listed forfeiture event 

is as follows: 

(I) FAILURE TO MARKET. — The first applicant fails 

to market the drug by the later of — 

 (aa) the earlier of the date that is — 

(AA) 75 days after the date on which the 

approval of the application of the first applicant 

is made effective under subparagraph (B)(iii); or 

(BB) 30 months after the date of submission of 

the application of the first applicant; or 

(bb) with respect to the first applicant or any other 

applicant (which other applicant has received 

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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 is withdrawn 

by the holder of the application approved under 

subsection (b) of this section. 

21 U.S.C. § 355(j)(5)(D)(i)(I) (emphasis added). 

The FDA stated its view of the matter in terms echoing 

the so-called “first prong” of Chevron, U.S.A. Inc. v. NRDC, 

467 U.S. 837 (1984), see, e.g., Mova, 140 F.3d at 1067, 

explaining: “The effect of patent delisting on eligibility for 

180-day exclusivity is expressly addressed by the [preceding] 

plain language.” Dorzolamide Hydrochloride-Timolo 

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Maleate Ophthalmic Solution — 180-day generic drug 

exclusivity, Dear ANDA Applicant Letter (Oct. 28, 2008) 

(“Hi-Tech Letter”) at 14 n.15., J.A. 121 n.15. A company 

otherwise entitled to exclusivity always forfeits it, said the 

agency, if events occur satisfying both paragraphs (aa) and 

(bb). Id. Paragraph (aa) gets checked off, thanks to its 

subsection (BB), as soon as 30 months have passed since the 

generic maker filed its ANDA—which had long since 

happened in both Cobalt’s and Hi-Tech’s cases. And 

paragraph (bb) is taken care of 75 days after the brand 

manufacturer delists the challenged patent (under subsection 

(CC)), regardless of the purpose or circumstance of the 

delisting request. Id. In the later of the two letter rulings, the 

FDA wrote that it had “considered and rejected in both this 

case and in the matter described in the [Cobalt] Decision, the 

argument that eligibility for 180-day exclusivity following the 

[brand maker’s] voluntary withdrawal of its patent should be 

governed not by the [new] forfeiture provisions, but by the 

rule established in Ranbaxy.” Hi-Tech Letter at 14, J.A. 121. 

Even though neither Cobalt nor Hi-Tech could have sold its 

generic drug before the date that the FDA said amounted to a 

“failure to market” event (since unchallenged patents 

protected the relevant brand drugs until a good deal later), the 

agency announced that both companies had forfeited 

exclusivity. Both Cobalt and Hi-Tech sought judicial review, 

were denied relief in district court, and didn’t appeal. 

 Teva filed the ANDAs at issue in this case on December 

18, 2003, for Cozaar, and May 24, 2004, for Hyzaar. Both 

contained a paragraph IV certification targeting Merck’s U.S. 

patent No. 5,608,075, which does not expire until 2014, and 

left unchallenged Merck’s other, earlier-expiring patents on 

the drugs. In response to Teva’s filing, Merck chose not to 

sue for infringement, as it might have. Instead, on March 18, 

2005, Merck asked the FDA to delist the 075 patent, which 

the agency did, though without making the action public until 

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April 18, 2008. Appellees’ Br. at 17. As of the present date, 

the FDA has awarded tentative approval to Teva’s ANDAs, 

see Teva, 638 F.Supp.2d at 58 n.12, and also to an ANDA 

filed by a competitor of Teva’s, Apotex Inc., to sell generic 

Hyzaar, see Reply Br. at 11 n.9. Though the FDA does not 

formally announce which ANDA filer was the first to submit 

a paragraph IV certification with respect to a brand drug (or 

whether any generic manufacturer is officially entitled to 

exclusivity) until the date on which generic sales can actually 

begin, see 21 C.F.R. § 314.430(b), Teva has every reason to 

believe that it was the first filer for both drugs at issue here: it 

points to the fact that the FDA’s own website lists the first 

paragraph IV certification against Hyzaar (i.e., “Losartan 

Potassium and Hydrochlorothiazide”) as having been filed on 

the very day that Teva filed its own Hyzaar ANDA. See 

http://www.fda.gov (enter “Hyzaar ANDA” in search box; 

select sole result, “[PDF] Paragraph IV Patent Certifications”; 

scroll to page 16) (last visited December 21, 2009). 

But in light of the Hi-Tech Letter, Teva saw the writing 

on the wall: under the interpretation of the “plain language” of 

the amended statute that the FDA had twice adopted, Teva 

had by the fall of 2008 already forfeited the exclusivity it 

believed it had earned—on August 12, 2006 for the generic 

Cozaar ANDA, and on January 16, 2007 for the generic 

Hyzaar ANDA.2

 Moreover, the agency had twice rejected the 

 

2

 The calculation under the FDA’s understanding of the statute 

looks like this: With respect to Cozaar, the date satisfying paragraph 

(aa) of the “Failure to Market” forfeiture event is August 12, 2006 

(30 months since the filing of the ANDA, see subsection (BB))—

and the date satisfying paragraph (bb) is 75 days after March 18, 

2005 (when Merck asked that the drug be delisted, see subsection 

(CC)); of the two dates, August 12, 2006 is the later one, hence 

(under the opening clause of § 355(j)(5)(D)(i)(I)) the forfeiture 

event. With respect to Hyzaar, the analysis is the same, except that 

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contention, made once by Teva itself as a commenter, that its 

chosen interpretation of the statute was untenable for a 

number of reasons, among them that it was inconsistent with 

Ranbaxy. Eschewing presentation of the same argument to 

the agency for yet a third time, though the first time with its 

own ANDA directly on the line, Teva went straight to the 

district court, hoping for a declaratory judgment rejecting the 

FDA’s interpretation and an order that the FDA grant it 

exclusivity on the date that generic losartan potassium 

competition would begin, April 6, 2010. 

* * * 

 The posture of this case raises several significant 

questions about its justiciability. One concerns conventional 

ripeness. A second, an issue of standing, implicates a 

potential—though ultimately illusory—conflict between, on 

one hand, decisions of this court regarding a plaintiff’s ability 

to obtain pre-enforcement review of a policy adopted by an 

agency in an adjudication and, on the other hand, the wellestablished teaching of Lujan v. Defenders of Wildlife, 504 

U.S. 555, 560-61 (1992), that the imminent threat of injury 

inflicted by the defendant and redressable by the court suffices 

for constitutional standing. 

Ripeness 

Pre-enforcement judicial review of an agency’s policy is 

available only if the dispute is ripe. Nat’l Park Hospitality 

 

30 months from the date of the ANDA’s filing fell on January 16, 

2007. See also Hi-Tech Letter at 15 (saying that the subsection 

(CC) event is calculated from the date of the brand maker’s 

delisting request, not the date that FDA makes public the delisting). 

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Ass’n v. Dep’t of Interior, 538 U.S. 803 (2003). The ripeness 

inquiry probes the fitness for review of the legal issue 

presented, along with (in at least some cases) “the hardship to 

the parties of withholding court consideration.” Id. at 808. 

The “fitness” prong of the analysis generally addresses 

“whether the issue is purely legal, whether consideration of 

the issue would benefit from a more concrete setting, and 

whether the agency’s action is sufficiently final.” National 

Ass’n of Home Builders v. U.S. Army Corps of Engineers, 440 

F.3d 459, 463 (D.C. Cir. 2006). 

In this case, the substantive issues Teva raises are 

undoubtedly “purely legal” in the relevant sense. They turn 

on questions of statutory construction, see Shays v. FEC, 414 

F.3d 76, 95 (D.C. Cir. 2005), and the interpretations chosen 

by the FDA and proposed by Teva both constitute bright-line 

rules, impervious, so far as appears, to factual variation. This 

in itself largely answers the question whether delay might 

afford additional “concrete[ness]”; it would not. As to 

finality, that largely resolves into the questions whether the 

FDA actually has a policy, whether it’s clear what will happen 

when the FDA applies the policy to Teva, and whether in any 

event it’s sufficiently likely that the policy will matter at all, 

given possible uncertainty whether Teva would be entitled to 

exclusivity even if the agency’s take on 21 U.S.C. 

§ 355(j)(5)(D)(i)(I)(bb)(CC) matched Teva’s. 

 While the FDA could in principle change its position as 

to the effect on generics’ exclusivity of brand makers’ 

requests to delist, an about-face seems extraordinarily 

unlikely. In its brief, the agency maintains, as it did in the 

Cobalt matter and the Hi-Tech matter, that the interpretation it 

adopted in those instances is compelled by the statute and that 

arguments to the contrary are plainly futile. Appellees’ Br. at 

42-43 (“[T]he plain language of subsection (CC) makes clear 

that the provision applies whenever a patent is withdrawn by 

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the [patent holder.]” (emphasis in original)). The mere 

theoretical possibility that an agency could alter its views on a 

legal issue before enforcing them against a party has not, in 

the past, precluded pre-enforcement review of those views. 

The same possibility exists for rulemakings, as we observed in 

Association of Bituminous Contractors, Inc. v. Andrus, 581 

F.2d 853, 859 (D.C. Cir. 1978), and for less finely chiseled 

agency decisions, see Appalachian Power Co. v. EPA, 208 

F.3d 1015, 1022 (D.C. Cir. 2000). As in Appalachian Power, 

there is here virtually no doubt, as a practical matter, what 

approach the agency will apply to Teva. And the implication 

of the FDA’s position for any exclusivity that Teva would 

otherwise merit is equally clear: as discussed above, the 

unambiguous result of the agency’s interpretation is that any 

such entitlement is already forfeited. 

 The government argues, however—relying chiefly on 

Pfizer Inc. v. Shalala, 182 F.3d 975 (D.C. Cir. 1999)—that the 

issue nevertheless remains unfit for review because the 

agency’s challenged interpretation may not be dispositive of 

the question whether Teva ultimately deserves exclusivity. In 

Pfizer a brand manufacturer (Pfizer) filed suit alleging that the 

FDA’s mere acceptance of an ANDA for processing was 

unlawful because the proposed generic drug differed in a 

crucial respect from the product it sought to replicate. 182 

F.3d at 978. We found the suit unripe, suggesting that despite 

the FDA’s tentative approval of the generic’s ANDA, grounds 

for uncertainty over whether the generic drug would ever be 

approved for sale persisted, posing concerns for “piecemeal 

litigation”: we instanced a possible FDA finding of a lack of 

bioequivalence, a matter that we obviously assumed the 

tentative approval left open. Id. at 980. 

The absence of any colorable factual dispute in Teva’s 

case compels a different outcome from Pfizer. The FDA 

makes no suggestion that any possible deficiency or 

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uncertainty in Teva’s ANDA could thwart final approval. It 

offers no reason to doubt the conclusion that the first 

paragraph IV certification against Hyzaar, filed on May 24, 

2004, was the paragraph IV certification against Hyzaar that 

Teva filed on May 24, 2004—which in turn dictates that Teva 

has satisfied the threshold requirement for exclusivity. The 

agency does caution that one or more of the statutory 

“forfeiture events” other than a “failure to market” might in 

any case deprive Teva of exclusivity before final approval—

but as Teva’s counsel ably demonstrated at oral argument, any 

such outcome is virtually inconceivable: Teva will not 

withdraw its ANDA, see 21 U.S.C. § 355(j)(5)(D)(i)(II); it 

will not amend its paragraph IV certification, see § (D)(i)(III); 

it has already obtained tentative approval, see § (D)(i)(IV); 

there is no indication that it will enter a collusive agreement 

with Merck, see § (D)(i)(V); and the now-delisted patent will 

not expire, see § (D)(i)(VI). See Oral Argument Tr. at 29-30 

(Dec. 7, 2009). In short, the question before us is one of pure 

statutory interpretation; we know precisely what the FDA 

thinks the answer is; and its resolution will almost certainly 

determine whether Teva is entitled to the exclusivity it claims. 

The second prong of the ripeness analysis addresses 

“whether postponing judicial review would impose an undue 

burden on” the parties. National Ass’n of Home Builders, 440 

F.3d at 464 (emphasis in original). This court has frequently 

suggested that hardship is not a sine qua non of ripeness. See 

id. at 465 (“[W]here . . . there are no significant agency or 

judicial interests militating in favor of delay, [lack of] 

hardship cannot tip the balance against judicial review.” 

(second bracketed alteration in original, internal quotation 

marks omitted)); Electric Power Supply Ass’n v. FERC, 391 

F.3d 1255, 1263 (D.C. Cir. 2004) (“The hardship prong under 

the ripeness doctrine is largely irrelevant in cases . . . in which 

neither the agency nor the court have [sic] a significant 

interest in postponing review.”); AT&T Corp. v. FCC, 349 

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F.3d 692, 700 (D.C. Cir. 2003) (“The ‘hardship’ prong of the 

Abbott Laboratories [v. Gardner, 387 U.S. 136 (1967)] test is 

not an independent requirement divorced from the 

consideration of the institutional interests of the court and 

agency. Thus, where there are no institutional interests 

favoring postponement of review, a petitioner need not satisfy 

the hardship prong.” (internal citation omitted)); Village of 

Bensenville v. FAA, 376 F.3d 1114, 1120 (D.C. Cir. 2004) 

(“[A]lthough the FAA reasonably asserts that the 

municipalities will not ‘suffer [any] immediate hardship from 

an EIS,’ Respondent’s Br. at 23, we see no benefit to us in 

postponing review[.]” (emphasis and second bracketed 

alteration in original)). In this case we need not consider the 

effect of a failure to show hardship, as Teva faces at least one 

harm from delayed judicial review cognizable in the ripeness 

analysis: a near-certain loss of the first-mover advantage to 

which the company claims entitlement.3 

 

3

 Teva also alleges hardship resulting from the severe impact 

of uncertainty on investment decisions that it must make well 

before the first legal opportunity to sell its generic, whether as an 

exclusive (as it claims) or not (under the FDA’s view). Delayed 

resolution of the issues in this case will, depending on the 

assumptions under which it operates, either (1) cost the company 

much of a valuable (and lawful) commercial opportunity, if it 

mistakenly assumes that the FDA view will prevail and therefore 

refrains from investing sufficient resources to prepare for the 

increased demand that would accompany an exclusive as opposed 

to a non-exclusive product launch, or (2) waste hundreds of millions 

in company resources invested in anticipation of fully exploiting its 

exclusivity, if it mistakenly assumes that its view will prevail. See 

Declaration of David Marshall, Vice President of New Products 

Portfolio Strategy for Teva Pharmaceuticals USA, Inc., at 4-8, J.A. 

128-32. (Of course a straddling investment decision would entail 

some of each cost.) We express no view as to whether such harm 

counts in the ripeness analysis. Cf. Exxon Mobil Corp. v. FERC, 

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If Teva is right on the merits (as we must assume it is for 

purposes of the ripeness inquiry, see U.S. Air Tour Ass’n v. 

FAA, 298 F.3d 997, 1014 (D.C. Cir. 2002)), then as of April 6, 

2010, it will be entitled to start enjoying its exclusivity period 

and to continue doing so for 180 days before additional firms 

lawfully enter the market. This “first-mover advantage” is a 

valuable asset. In Mova we observed “the loss of [a generic’s] 

officially sanctioned head start” can, at least in some 

circumstances, yield a “severe economic impact.” 140 F.3d at 

1066 n.6 (internal quotation marks omitted). If we refrained 

from adjudicating this dispute now, Teva would almost 

certainly face competition from Apotex on April 6, see 21 

C.F.R. § 314.105(d) (explaining that a “tentative” approval is 

the same as a final approval with a delayed effective date)—

an injury that would not be remedied by Teva’s securing 180 

days of exclusivity later on. 

District courts in this circuit routinely reach the merits of 

generic manufacturers’ claims to exclusivity before the FDA 

has granted final approval to any ANDA concerning the drug 

at issue. See, e.g., Teva, 548 F.3d 103 (earliest possible date 

of generic competition June 29, 2008, see Appellee’s Br. at 5; 

district court decision April 11, 2008, id. at 4); Ranbaxy, 469 

F.3d 120 (earliest possible date of generic competition June 

23, 2006, see Appellants’ Br. at 11; district court decision 

April 30, 2006, id. at 1). This makes good sense; the 

exclusivity reward that Congress made available as an 

incentive for patent challenges is time-sensitive, and where 

there is no material ambiguity about essential facts a court can 

 

501 F.3d 204, 208 (D.C. Cir. 2007) (hardship ample where 

postponing review would cause uncertainty and cost to prospective

applicant for approval to build pipeline and would “tend to inhibit 

or delay investment” in a project Congress had deemed important). 

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readily decide whether it has been earned in advance of 

generic competition’s onset. The alternative approach—

delaying review until the agency has made its technically 

tentative decisions final—puts a court in an awkward bind, 

unless it miraculously manages to resolve the merits issue 

more or less instantaneously. Apart from that risky and 

improbable course, there would be two possible stopgaps 

available to preserve the first-mover advantage. The court 

could delay all generic competition, thereby thwarting the 

statutory purpose of achieving swift competition by generics 

(a factor that would in turn weigh against preliminary 

injunctive relief under the “public interest” component of the 

standard test). Or it could delay the entrance of the 

exclusivity claimant’s generic rivals into the market, thereby 

giving the claimant precisely the relief it seeks, simply in 

order to allow the court time to decide whether such relief was 

warranted. The technical possibility that a judge might 

embrace one of these highly imperfect alternatives can hardly 

be thought to protect Teva from the hardship made likely by 

delayed review. 

When the question at issue is well-defined, and when 

withholding judicial consideration would cause undeniable 

harm, as here, ripeness concerns pose no obstacle to preenforcement review. 

Standing

The FDA embraced the statutory interpretation that Teva 

now seeks to challenge not in a rulemaking but in two 

adjudications to which Teva was not a party (though actively 

commenting in one). Our past cases suggest some uncertainty 

whether a dispute in that posture can ever be justiciable. See, 

e.g., Radiofone, Inc. v. FCC, 759 F.2d 936, 938 (D.C. Cir. 

1985) (opinion of then-Judge Scalia) (“All persons adversely 

affected by [a] rule [“addressed, so to speak, to the world at 

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17

large”] would have standing to challenge its compliance with 

legal prescriptions designed for their protection. . . . The 

situation is different, however, when an interpretation of a 

statute, or some other legal principle, is set forth as the 

rationale of an adjudication.” (emphasis in original)). 

But straightforward application of hornbook doctrine 

yields the conclusion that Teva has standing. Article III of the 

Constitution requires that a federal court plaintiff allege an 

actual or imminent injury that is fairly traceable to the 

defendant’s challenged conduct and redressable in the judicial 

proceeding. Lujan, 504 U.S. at 560-61. In this instance, the 

latter two elements are clearly satisfied. Any imminent 

deprivation of Teva’s allegedly deserved exclusivity would be 

directly attributable to the FDA’s statutory interpretation. 

And if we agreed with Teva on the merits, we (or the district 

court) could issue precisely the declaration it has sought, 

announcing that requests to delist challenged patents should 

have no more legal significance in the amended statutory 

regime than they did in the old one, as per Ranbaxy, 469 F.3d 

at 126. 

The “injury” prong of the standard standing inquiry is a 

bit thornier—but only to the extent of the trivial uncertainty 

whether the FDA will on April 6, 2010 stick to the 

interpretation that Teva attacks here. As discussed in the 

ripeness analysis above, however, we find no uncertainty to 

speak of on the matter. It is clear what the FDA will do 

absent judicial intervention and what the effect of the 

agency’s action will be. The inescapable implication is that 

Teva faces an imminent threat of the same harm that has 

sufficed for Article-III injury purposes in all of our past drugapproval cases: the impending prospect of allegedly unlawful 

competition in the relevant market. See, e.g., Bristol-Myers 

Squibb Co. v. Shalala, 91 F.3d 1493, 1497 (D.C. Cir. 1996) 

(“[W]here . . . a statutory provision reflects a legislative 

USCA Case #09-5281 Document #1232766 Filed: 03/02/2010 Page 17 of 35
18

purpose to protect a competitive interest, the protected 

competitor has standing to require compliance with that 

provision.”); Ranbaxy, 469 F.3d 120 (adjudicating a dispute in 

which the only injury at issue was the prospective loss of a 

generic manufacturer’s 180-day period of marketing 

exclusivity). For the purpose of the classic constitutional 

standing analysis, it makes no difference to the “injury” 

inquiry whether the agency adopted the policy at issue in an 

adjudication, a rulemaking, a guidance document, or indeed 

by ouija board; provided the projected sequence of events is 

sufficiently certain, the prospective injury flows from what the 

agency is going to do, not how it decided to do it. Cf. City of 

Los Angeles v. Lyons, 461 U.S. 95, 106 n.7 (1983) (“[T]o have 

a case or controversy . . . [plaintiff] would have to credibly 

allege that he faced a realistic threat from the future 

application of the City’s policy.”). 

The question, then, is whether the normal application of 

the constitutional standing doctrine is suspended when the 

court’s knowledge that an agency is about to inflict injury on a 

party derives from an agency policy that originated in an 

adjudication (or several). The strongest support for such a 

principle would be Sea-Land Service, Inc. v. Department of 

Transportation, 137 F.3d 640, 648 (D.C. Cir. 1998), in which 

we rejected a pre-enforcement challenge to an agency 

interpretation born of an adjudication, noting that a policy’s 

“mere precedential effect within an agency is not, alone, 

enough to create Article III standing, no matter how 

foreseeable the future litigation” involving the plaintiff. We 

have articulated a similar idea, albeit in weaker form, on 

numerous other occasions. See, e.g., Shipbuilders Council of 

America v. United States, 868 F.2d 452, 456 (D.C. Cir. 1989) 

(“[W]e know of no authority recognizing that the mere 

potential precedential effect of an agency action affords a 

bystander to that action a basis for complaint.”); American 

Family Life Assurance Co. v. FCC, 129 F.3d 625, 629 (D.C. 

USCA Case #09-5281 Document #1232766 Filed: 03/02/2010 Page 18 of 35
19

Cir. 1997) (“AFLAC”) (“[W]e have said before, and we say 

again, that the ‘mere precedential effect of [an] agency’s 

rationale in later adjudications’ is not an injury sufficient to 

confer standing on someone seeking judicial review of the 

agency’s ruling.” (quoting Radiofone, 759 F.2d at 939)). 

In all of these cases, we rebuffed efforts to obtain preenforcement review of policies embraced by agencies in 

adjudications. In each instance, however, the failure to 

demonstrate standing is more naturally understood as arising 

from the lack of a sufficiently imminent and concrete injury 

than from some sort of ad hoc exception to otherwiseuniversally applicable constitutional doctrine. Radiofone, for 

example, addressed whether parties allegedly aggrieved by 

reasoning employed by the FCC in an adjudication could 

appeal the agency’s order even though the recipient of the 

order had since ceased doing business. 759 F.2d at 937-38. 

There was no suggestion in any of the panel’s three 

opinions—including then-Judge Scalia’s, which didn’t in any 

case garner a majority for its standing passage—that the 

parties seeking review were at risk of injury from imminent 

application of the principle the agency had articulated. 

Shipbuilders similarly concerned no identifiable prospective 

application of the allegedly offending policy. We explicitly 

noted, in fact, that plaintiffs had failed to present “specific, 

concrete facts demonstrating that the challenged [ruling 

would] harm” them, adding that their “hypothesizing . . . 

never descends from a highly general plane; it remains at a 

considerable distance from the more concrete pleas” needed to 

establish standing. Shipbuilders, 868 F.2d at 457. While the 

opinion also framed the complaint as an impermissible 

“request for judicial advice—a declaration that a line of 

agency rulings should henceforth have no precedential effect,” 

id. at 456, we simply did not address the scenario in which a 

line of agency rulings threatened a party with an imminent 

injury otherwise ample for Article III purposes.

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20

Sea-Land, too, did not involve a party pointing to a 

particular imminent application of the disputed agency policy. 

The justiciability problem in that case arose from the 

“principle that prevailing parties lack standing to appeal,” 137 

F.3d at 647—which is undoubtedly correct as a general 

matter, but which does not foreclose review of a case in which 

a party is aggrieved not by the “mere potential precedential 

effect of an agency action,” Shipbuilders, 868 F.2d at 456, but 

instead by the impending application of an agency’s statutory 

interpretation, the firmness of which is not in dispute, on a 

fast-arriving date certain. The Sea-Land opinion, to be sure, 

phrased the proscription against challenges to agency 

precedent qua precedent as one applying “no matter how 

foreseeable the future litigation.” 137 F.3d at 648. But we 

could not possibly have purported to overturn well-established 

Supreme Court precedent holding that an imminent threat of 

injury suffices for standing, see Lujan, 504 U.S. at 560—

particularly in a case not involving the slightest allegation of 

such a threat. A more sensible reading of Sea-Land is one that 

leaves it consistent with Lujan and its equally binding 

progeny: merely foreseeable future litigation resulting from a 

statutory interpretation that an agency has adopted in an 

adjudication is, “alone,” 137 F.3d at 648—i.e., without 

more—too speculative to satisfy Article III’s injury-in-fact 

requirement. An agency’s imminent application of its 

established interpretation of a statute, at the potential cost of 

hundreds of millions of dollars to the regulated firm, remains, 

by contrast, as sufficient for standing purposes today as it was 

before Sea-Land. See Marshall Declaration at 4-5, J.A. 128-

29 (explaining why Teva “stands to lose hundreds of millions 

of dollars in net revenues during its first year of generic 

losartan potassium products sales as a direct result of the 

[FDA’s policy]”).

No other case we’ve decided concerning a preenforcement challenge to an agency interpretation adopted via 

USCA Case #09-5281 Document #1232766 Filed: 03/02/2010 Page 20 of 35
21

adjudication counsels a contrary result. See AFLAC, 129 F.3d 

at 628 (“Petitioner reports no litigation on the horizon . . . no 

simmering disputes about to erupt into a lawsuit[.]”); Shell Oil 

Co. v. FERC, 47 F.3d 1186, 1202 (D.C. Cir. 1995) (“Shell’s 

allegations of injury rest on a hypothetical scenario . . . . 

Although such injury is not inconceivable, we are 

unpersuaded that it is imminent.” (emphasis in original)); 

Crowley Caribbean Transp., Inc. v. Pena, 37 F.3d 671, 674 

(D.C. Cir. 1994) (finding impact of agency’s challenged 

position on party seeking review “nebulous and remote”); 

Aeronautical Radio, Inc. v. FCC, 983 F.2d 275, 284 (D.C. Cir. 

1993) (“There is no indication in the record . . . that the 

Commission is likely to attempt to [enforce the challenged 

interpretation against TRW, the party seeking review]. 

TRW’s alleged injury is therefore merely conjectural.” 

(internal quotation marks omitted)). 

We have, on the other hand, allowed a party to challenge 

in advance an agency policy adopted via adjudication when 

the prospect of impending harm was effectively certain. In 

International Brotherhood of Electrical Workers v. ICC, 862 

F.2d 330 (D.C. Cir. 1988), a union sought judicial review of 

the Interstate Commerce Commission’s exercise of 

jurisdiction to review an arbitration award—even though the 

ICC, having accepted jurisdiction, had ruled in favor of the 

union. 862 F.2d at 334. We found ripeness and standing 

requirements satisfied, noting that “[b]ecause of the ICC’s 

decision to review arbitration awards, the union will be 

subject to agency review in future cases involving disputes” of 

the same type. Id. As we later explained, International 

Brotherhood stands for the proposition that the “concrete cost 

of an additional proceeding is a cognizable Article III injury,” 

Sea-Land, 137 F.3d at 648—notwithstanding that the source 

of the harm was an agency position adopted in an adjudication 

whose outcome was no longer at issue. Teva’s alleged injury 

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22

threatens to impose no less of a “concrete cost” and with no 

less certainty. 

We have, moreover, explicitly sanctioned review of a case 

in the present posture—albeit while framing the justiciability 

question as one of ripeness rather than standing. Association 

of Bituminous Contractors v. Andrus, 581 F.2d 853, 858-59 

(D.C. Cir. 1978), was precisely a pre-enforcement challenge 

to a policy adopted in a previous adjudication by the Interior 

Board of Mine Operations Appeals. The doctrine of standing 

has undoubtedly evolved significantly since the time of that 

decision (though not generating any new limits on imminent 

injuries that happen to be traceable to adjudicative rules)—but 

the case does demonstrate that we have previously considered 

the lawfulness of an agency policy with precisely the kind of 

provenance as the policy Teva challenges, where imminent 

application of the policy was about to inflict injury. See also 

Independent Insurance Agents of America, Inc. v. Hawke, 211 

F.3d 638 (D.C. Cir. 2000) (adjudicating dispute over agency 

interpretation adopted in letter ruling to which district court 

plaintiff was not party); Air Transport Ass’n of America, Inc. 

v. FAA, 291 F.3d 49 (D.C. Cir. 2002) (same, where dispute 

concerned letter ruling to which circuit court petitioner was 

not party). 

We see no basis for concluding that this court has created 

an exception to the Supreme Court’s constitutional standing 

doctrine excising cases like Teva’s from the class of otherwise 

justiciable matters. Teva presents a valid Article III case or 

controversy. 

* * * 

On the merits, we review de novo the district court’s 

grant of summary judgment to the FDA. See Kersey v. 

USCA Case #09-5281 Document #1232766 Filed: 03/02/2010 Page 22 of 35
23

Washington Metropolitan Area Transit Authority, 586 F.3d 

13, 16 (D.C. Cir. 2009). We evaluate the FDA’s 

interpretations of the Food, Drug, and Cosmetic Act adopted 

in letter rulings under the familiar two-part Chevron 

framework. Mylan Labs., Inc. v. Thompson, 389 F.3d 1272, 

1280 (D.C. Cir. 2004). But see Matthew C. Stephenson and 

Adrian Vermeule, Chevron Has Only One Step, 95 Va. L. 

Rev. 597 (2009). 

Teva offers two principal reasons to conclude that the 

FDA may not allow a brand manufacturer’s request to delist a 

challenged patent to trigger a statutory “forfeiture event” 

resulting in the loss of a generic’s exclusivity. One reason 

takes the form of linguistic analysis focused almost entirely on 

the text of the “failure to market” forfeiture event and a 

related provision. The 2003 amendments, Teva explains, 

introduced a new procedure, a counterclaim in the brand 

manufacturer’s patent infringement suit, through which 

generic companies can force brand companies to delist an 

improperly asserted patent. See 21 U.S.C. 

§ 355(j)(5)(C)(ii)(I).4 This counterclaim provision is the only 

portion of the statute that explicitly provides for the delisting 

of a patent after it has been challenged in an ANDA. In the 

company’s view, that singular reference requires the 

 

4

 The purpose of this procedure, says Teva, is to offer generics 

a means of combating brand companies’ practice of delaying 

generic competition by listing “sham patents,” baiting a generic into 

filing a paragraph IV certification, and then filing an infringement 

suit—which typically brings a 30-month stay of generic 

competition. Appellant’s Br. at 42; see 21 U.S.C. § 355(j)(5)(B)(iii) 

(creating the stay and subjecting it to various limits such as the 

generic manufacturer’s earlier success in the suit); aaiPharma Inc. 

v. Thompson, 296 F.3d 227, 236 (4th Cir. 2002) (describing 

precisely this delay tactic). 

USCA Case #09-5281 Document #1232766 Filed: 03/02/2010 Page 23 of 35
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conclusion that the counterclaim provision describes the only 

scenario in which the FDA may delist a challenged patent. 

Obviously, then, no other kind of delisting could ever serve as 

an occurrence satisfying the terms of the “failure to market” 

forfeiture trigger listed at 21 U.S.C. 

§ 355(j)(5)(D)(i)(I)(bb)(CC). 

The FDA, for its part, responds that “the plain language 

of the statute contains no limitation on when delisting can 

occur.” Appellees’ Br. at 44. Brand manufacturers are thus 

free to delist challenged patents whenever they please—and 

any such delisting satisfies subsection (CC) of the “failure to 

market” forfeiture section. Id. at 45-46. In effect, the agency 

says, the counterclaim provision says nothing about its being 

an exclusive route to delisting, and if Congress meant to 

confine subsection (CC) delistings to those arising from the 

counterclaim procedure, it would have been natural for it to 

place that limitation in (CC). 

While Teva’s purely linguistic argument shows its 

understanding of the relevant language to be perfectly 

plausible, it hardly rules out alternative readings that, absent 

consideration of statutory structure, also appear plausible. See 

Chevron, 467 U.S. at 844-45; INS v. Cardoza Fonseca, 480 

U.S. 421, 443 (1987) (considering “the structure of the Act” at 

Chevron step one). As the FDA notes, there is simply no 

express preclusion of non-counterclaim delistings, or of such 

delistings’ triggering forfeiture, in either of the places one 

might expect to find one, the counterclaim section or (CC).

This brings us to Teva’s structural argument. Ranbaxy, 

Teva notes, concerned an FDA policy with a virtually 

identical effect. See 469 F.3d at 125. This court condemned 

that rule, partly because it allowed a brand manufacturer, 

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by delisting its patent, to deprive the generic applicant of 

a period of marketing exclusivity. By thus reducing the 

certainty of receiving a period of marketing exclusivity, 

the FDA’s delisting policy diminishe[d] the incentive for 

a manufacturer of generic drugs to challenge a patent . . . 

in the hope of bringing to market a generic competitor for 

an approved drug without waiting for the patent to expire. 

The FDA may not, however, change the incentive 

structure adopted by the Congress, for the agency is 

bound “not only by the ultimate purposes Congress has 

selected, but by the means it has deemed appropriate, and 

prescribed, for the pursuit of those purposes.” 

Id. at 126 (emphasis added, citation omitted). Nothing in the 

2003 amendments to the Food, Drug, and Cosmetic Act 

altered that essential incentive structure, says Teva, so the 

preceding portion of Ranbaxy remains applicable even under 

the new regime. Indeed, it is true that the 2003 amendments 

say nothing specific to undermine our prior understanding of 

the statute’s intended incentive structure. 

 But the FDA sees a way in which its interpretation of 

subsection (CC) accomplishes at least some congressional 

purpose. Without the possibility of a forfeiture of exclusivity 

resulting from the delisting of a challenged patent, a generic 

manufacturer that had been awarded exclusivity could delay 

all generic competition more or less indefinitely, since by 

statute the agency can’t approve competing generics until 180 

days after the first paragraph-IV filer has begun commercial 

marketing of its newly approved product. See 21 U.S.C. 

§ 355(j)(5)(B)(iv)(I). Congress enacted the “failure to 

market” provision, in the agency’s view, precisely to avoid 

such “parking” of exclusivity; allowing a brand maker to 

trigger forfeiture by delisting a challenged patent positively 

furthers that legislative aim. Appellees’ Br. at 45. Besides, 

the agency says, “Consumers benefit from lower drug prices 

USCA Case #09-5281 Document #1232766 Filed: 03/02/2010 Page 25 of 35
26

immediately without having to wait for one generic company 

to enjoy 180 days of exclusivity when the patent owner itself 

takes the position that a patent should not hinder FDA 

approval of ANDAs.” Id. 

 The real issue, then, is whether the FDA is right that the 

2003 addition of the “failure to market” forfeiture provision, 

21 U.S.C. § 355(j)(5)(D)(i)(I), altered the statute’s incentive 

structure to the point that Ranbaxy’s reasoning no longer 

controls the agency’s treatment of a delisting request in the 

wake of a paragraph-IV filing. 

 The terms of § 355(j)(5)(D)(i)(I), quoted in full in the 

opening of this opinion, create five possible dates on which a 

generic manufacturer otherwise entitled to exclusivity can 

forfeit it: (1) 75 days after the agency finally approves the 

relevant ANDA; (2) 30 months after the generic submits the 

relevant ANDA; (3) 75 days after a court judgment that the 

challenged patent is invalid or not infringed; (4) 75 days after 

a suit over the challenged patent is settled favorably to the 

ANDA filer; and (5) 75 days after the challenged patent is 

delisted. No forfeiture occurs, however, unless one of dates 

(1)-(2) and one of dates (3)-(5) have come to pass. See id.; 

FDA Letter re 180-day exclusivity, Docket No. 2007N-0389, 

ANDA 77-165: Granisetron Hydrochloride Injection, 1 

mg/mL, at 5, J.A. 68 (“We find that under the plain language 

of the statute, 180-day exclusivity is not forfeited for failure to 

market when an event under subpart (aa) has occurred, but . . . 

none of the events in subpart (bb) has occurred.”). Setting 

aside the subsection at issue in this case—listed as (5) above, 

and codified as (bb)(CC)—the “failure to market” forfeiture 

provision does not permit a brand manufacturer to vitiate a 

generic’s exclusivity without the generic manufacturer’s 

having had some say in the matter. No forfeiture can take 

place unless the brand manufacturer brings an infringement 

suit against the generic and either loses on the merits or enters 

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27

an unfavorable settlement agreement. The latter necessarily 

entails some participation by the generic; the former 

invariably involves significant expense for the brand 

manufacturer, and affords the victorious generic the 

opportunity to ask the court to delay entering final judgment 

until a date that would not trigger forfeiture prematurely—

before the agency grants final approval to the relevant ANDA. 

 The FDA’s view turns the last alternative among events 

(3)-(5) into a fundamentally different forfeiture trigger: it is 

satisfied when the patent targeted in a paragraph-IV filing “is 

withdrawn by the” brand manufacturer, full stop—meaning 

that Congress has now explicitly provided for a scenario in 

which the brand maker can unilaterally deprive the generic of 

its exclusivity. The agency, however, offers not a single 

cogent reason why Congress might have permitted brand 

manufacturers to trigger subsection (CC) by withdrawing a 

challenged patent, outside the counterclaim scenario identified 

by Teva. 

 The argument that the plain language of the statute 

imposes no limit on the circumstances in which the agency 

may effectuate delisting requests fails. Precisely the same 

could have been said of the version of the statute that Ranbaxy

addressed, and we nevertheless concluded that its structure 

precluded an FDA rule allowing the agency “to delist a patent 

upon the request of the [brand manufacturer]” when the 

delisting would rob the generic maker of earned exclusivity. 

469 F.3d at 125. 

The agency fares no better in suggesting that allowing the 

delisting of challenged patents prevents the ANDA filer from 

“creat[ing] a bottleneck” blocking generic competition by 

“parking” its exclusivity. Appellees’ Br. at 45. As a parkingprevention device, letting brand makers delist challenged 

patents in order to trigger a forfeiture of exclusivity would be 

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28

completely ineffective; given the incentives for the brand 

manufacturer, it will be used only where its impact on 

Congress’s scheme is most destructive. If the generic appears 

likely to park its exclusivity, the brand maker will simply 

refrain from delisting altogether, thus enjoying an extended 

period during which it faces no generic competition while the 

exclusivity-holder bides its time.5 If the generic appears 

unlikely to park its exclusivity, the brand maker can delist 

well before the generic can go to market, thus eviscerating the 

exclusivity incentive altogether. In other words, the only case 

in which a unilateral right for brand makers to delist 

challenged patents actually results in the outcome the FDA 

touts is when the brand maker deliberately accelerates the 

onset of generic competition—an utterly implausible scenario. 

In other cases, the brand maker either does nothing to prevent 

parking, or prevents parking that was unlikely to have 

occurred in any event, but with precisely the effect that 

Ranbaxy proscribed. Thus the “parking” concern offers no 

reason to conclude that the 2003 addition of forfeiture 

provisions meant to give the brand manufacturer a right to 

unilaterally vitiate a generic’s exclusivity. 

 Finally, the FDA’s sole effort to root its interpretation in 

the policy underlying Hatch-Waxman—the thought that the 

interpretation benefits consumers by allowing full generic 

competition without a 180-day delay—betrays a 

misunderstanding of the exclusivity incentive. The statute’s 

grant of a 180-day delay in multiple generic competition for 

the first successful paragraph IV filer is a pro-consumer 

 

5

 We note, in fact, that many instances of generics’ parking 

their exclusivity have evidently arisen thanks to agreements with the 

brand maker itself to delay generic competition. See Federal Trade 

Commission, Authorized Generics: An Interim Report ch. 2, at 1 

(2009). 

USCA Case #09-5281 Document #1232766 Filed: 03/02/2010 Page 28 of 35
29

device. And it happens to be precisely the device Congress 

has chosen to induce challenges to patents claimed to support 

brand drugs. The statute thus deliberately sacrifices the 

benefits of full generic competition at the first chance allowed 

by the brand manufacturer’s patents, in favor of the benefits of 

earlier generic competition, brought about by the promise of a 

reward for generics that stick out their necks (at the potential 

cost of a patent infringement suit) by claiming that patent law 

does not extend the brand maker’s monopoly as long as the 

brand maker has asserted. As Congress deliberately created 

the 180-day exclusivity bonus, the FDA cannot justify its 

interpretation by proudly proclaiming that it has eviscerated 

that bonus. 

 We see nothing in the 2003 amendments to the Food, 

Drug, and Cosmetic Act that changes the structure of the 

statute such that brand companies should be newly able to 

delist challenged patents, thereby triggering a forfeiture event 

that deprives generic companies of the period of marketing 

exclusivity they otherwise deserve. For that reason, the 

interpretation of the statute that the FDA has adopted in two 

recent adjudications, and that it regards itself as bound by law 

to apply to Teva’s ANDAs for losartan products, fails at 

Chevron step one. Cf. Ranbaxy, 469 F.3d at 126; Cardoza 

Fonseca, 480 U.S. at 443. 

* * * 

 One matter remains. Teva’s prospective generic losartan 

competitor, Apotex, sought to intervene as a defendant in 

Teva’s suit before the district court. The court denied the 

intervention on the ground that Apotex lacked standing. Teva,

638 F.Supp.2d at 59. Apotex has appealed that ruling, but has 

also, with the consent of both parties, expressed its substantive 

views of this case in an amicus brief, which we have 

USCA Case #09-5281 Document #1232766 Filed: 03/02/2010 Page 29 of 35
30

considered no less than if Apotex had formally intervened. As 

Apotex and the FDA are as a practical matter identically 

positioned on the issues (though from radically different 

perspectives), we think it prudent to follow the line of 

precedent in this circuit declining to assess a would-be 

intervenor’s standing when answering the question wouldn’t 

affect the outcome of the case. See Comcast Corp. v. FCC, 

579 F.3d 1, 6 (D.C. Cir. 2009) (“We need not decide whether 

[the harm alleged by a prospective intervenor] is too 

‘conjectural or hypothetical’ to support standing . . . because 

‘if one party has standing in an action, a court need not reach 

the issue of the standing of other parties when it makes no 

difference to the merits of the case.’” (quoting Railway Labor 

Executives Ass’n v. United States, 987 F.3d 806, 810 (D.C. 

Cir. 1993))); see also McConnell v. FEC, 540 U.S. 93, 233 

(2003) (“It is clear . . . that the Federal Election Commission 

(FEC) has standing, and therefore we need not address the 

standing of the intervenor-defendants, whose position here is 

identical to the FEC’s.”). We note that courts appear not to 

have considered whether a party whose attempt to intervene 

has been pretermitted in this fashion (or a party whose 

standing has otherwise been left unresolved) can seek review 

of the court’s decision on the merits, as a successful 

intervenor could. Perhaps courts have assumed that that issue 

could reasonably be kicked up the road to the possible 

appellate body. Finally, we also note that Apotex might move 

again for intervention in future proceedings before the district 

court in this case in light of changed circumstances—

specifically that Apotex’s ANDA has now earned tentative 

approval from the FDA, effectively removing the obstacle to 

standing on which the district court relied. 

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31

* * * 

 We therefore reverse the judgment of the district court, 

but, as the court has yet to address the appropriateness of each 

form of relief that Teva has sought, we remand for further 

proceedings not inconsistent with this opinion. 

So ordered.

USCA Case #09-5281 Document #1232766 Filed: 03/02/2010 Page 31 of 35
KAREN LECRAFT HENDERSON, Circuit Judge, dissenting:

 I dissent from the majority opinion because the issue Teva

seeks to litigate—its statutory eligibility vel non to exclusively

market generic versions of Cozaar and Hyzaar, brand name

drugs manufactured by Merck & Co., Inc. (Merck)—will not be

ripe unless and until the United States Food and Drug

Administration (FDA) issues its final decision either granting or

denying Teva’s Abbreviated New Drug Application (ANDA).

The United States Supreme Court has established a two-pronged

test for determining ripeness, requiring that the court analyze:

“(1) the fitness of the issues for judicial decision and (2) the

hardship to the parties of withholding court consideration.”

Nat’l Park Hospitality Ass’n v. Dep’t of Interior, 538 U.S. 803,

808 (2003) (citing Abbott Labs. v. Gardner, 387 U.S. 136, 149

(1967)). This action satisfies neither prong of the ripeness test

as is clear from our decision in Pfizer Inc. v. Shalala, 182 F.3d

975 (D.C. Cir. 1999). 

In that case, Pfizer filed a “citizen petition” with the FDA

asking that the agency recognize as “a distinct dosage form” a

patented “osmotic pump” used as an extended release

mechanism for Pfizer’s brand drug Procardia XL. Pfizer, 182

F.3d at 977. Almost four years later—with the petition still

pending—Mylan Pharmaceuticals, Inc. (Mylan) filed an ANDA

to market a generic version of Procardia XL, claiming

pharmaceutical equivalence notwithstanding Mylan’s product

used a different release mechanism. After the FDA accepted

Mylan’s ANDA for processing but before it decided whether to

approve it, Pfizer filed a suit in district court challenging the

FDA’s acceptance of the ANDA on the ground that the two

products were not equivalent because Pfizer’s osmotic pump

was a unique dosage form and thus distinct from Mylan’s

mechanism. The district court held that Pfizer’s challenge to

Mylan’s application was not ripe for judicial review but that its

unresolved citizen petition was. Id. at 978. On appeal, we

found neither challenge ripe. 

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2

1

The FDA’s “tentative approval” of Teva’s ANDA is not, as Teva

suggests, Reply Br. at 10-11, the final word on its generic drug’s

equivalence. See Pfizer, 182 F.3d at 980 (although FDA’s post-oral

argument tentative approval of Mylan’s generic made it “more likely

We first rejected Pfizer’s argument that “once having

decided, based upon the information contained in Mylan’s

application, that Mylan’s drug uses the same dosage form as

Procardia XL®, the FDA will not ‘alter its views with respect to

the necessity of Mylan filing a suitability petition.’ ” Id. at 978.

We explained: 

The decision to accept Mylan’s ANDA for processing

as a pharmaceutical equivalent to Procardia XL® is . . .

merely the first step in the agency’s approval process.

The critical fact remains that the FDA may never

approve Mylan’s application—whether because it

decides in the end that the dosage form of Mylan’s

drug is different from that of Procardia XL® or for

some entirely different reason, such as a lack of

bioequivalence. Therefore, “depending upon the

agency’s future actions . . . review now may turn out to

have been unnecessary” and could deprive the agency

of the opportunity to apply its expertise and to correct

any mistakes it may have made. 

Id. (quoting Ohio Forestry Ass’n v. Sierra Club, 523 U.S. 726,

736 (1998)) (first ellipsis added). Teva faces the same hurdle

here. We do not know whether the FDA’s final decision will

approve Teva’s ANDA or what the FDA’s reasoning will be if,

as the majority forecasts, maj. op. at 11-13, it does not. The

FDA may conclude Teva forfeited its eligibility upon Merck’s

delisting of its patents, as Teva and the majority insist it will, or

it may reject Teva’s application based on one of the other

forfeiture provisions “or for some entirely different reason, such

as a lack of bioequivalence.” Pfizer, 182 F.3d at 978.1

 Because

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that the FDA w[ould] eventually approve Mylan’s drug, the agency’s

tentative approval cause[d] Pfizer no hardship at present or in the near

future, nor d[id] it render Pfizer’s challenge fit for review”).

the FDA has not yet issued its decision we are unable to divine

its substance. Given this uncertainty and the consequent

possibility the court may not need to resolve the

delisting/forfeiture issue after the FDA’s final decision, Teva’s

challenge to the FDA’s previous decisions in other proceedings

is not now fit for review under the first prong of the ripeness

test. In short, “[i]t makes no sense for us to anticipate a wrong

when none may ever arise.” Cronin v. FAA, 73 F.3d 1126, 1132

(D.C. Cir. 1996).

Nor does Teva fare better under the test’s hardship prong as

we applied it in Pfizer. There we explained that Pfizer was not

able to “point to any imminent hardship arising from the FDA’s

acceptance of Mylan’s ANDA”:

Before Pfizer could suffer its claimed “economic injury

from unlawful competition,” FDA approval for a

pharmaceutical equivalent to Procardia XL® would

have to be not only sought but granted. That has not

happened. Therefore “no irremediable adverse

consequences flow from requiring a later challenge.”

Pfizer, 182 F.3d 979 (quoting Toilet Goods Ass’n v. Gardner,

387 U.S. 158, 164 (1967)). For the same reason, Teva too will

suffer no imminent hardship if review is postponed. See Fed.

Express Corp. v. Mineta, 373 F.3d 112, 119 (D.C. Cir. 2004)

(hardship prong not satisfied because “postponing review . . .

w[ould] not be a hardship to [petitioners], let alone a hardship

that is ‘immediate, direct, and significant.’ ” (quoting State Farm

Mut. Auto. Ins. Co. v. Dole, 802 F.2d 474, 480 (D.C. Cir.

1986))) (emphasis added). As in Pfizer, the delay will not

“foreclose[ the appellant’s] right ever to get meaningful judicial

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2

And contrary to my colleagues’ lack of confidence in judicial

alacrity, maj. op. at 15-16, courts make speedy decisions on injunction

applications in ANDA cases all the time. See, e.g., Apotex, Inc. v.

FDA, C.A. No. 06-627 (D.D.C. Apr. 19 2006); Biovail Corp. v. FDA,

C.A. No. 06-1487 (D.D.C. Aug. 25, 2006); Merck & Co. v. FDA, C.A.

No. 01-1343 (D.D.C. June 20, 2001).

3

In support of ripeness, the majority asserts: “District courts

routinely reach the merits of generic manufacturers’ claims to

exclusivity before the FDA has granted final approval to any ANDA

concerning the drug at issue.” Maj. op. at 15 (citing Teva Pharms.,

USA, Inc. v. Leavitt, 548 F.3d 103 (D.C. Cir. 2008); Ranbaxy Labs.,

Ltd. v. Leavitt, 469 F.3d 120 (D.C. Cir. 2006)). Leaving aside what

effect a court’s routine practice may have on an issue’s ripeness vel

non, I know of no instance where the district court reached the merits

of an ANDA before the FDA has issued any decision regarding the

plaintiff and the issue raised. In the two cases the majority cites, the

district court directly reviewed FDA decisions denying relief to the

plaintiffs. See Teva Pharms., 548 F.3d at 105 (reviewing denial of

citizen petition contesting FDA’s delisting of patent certified in its

ANDA); Ranbaxy Labs., Ltd., 469 F.3d at 121 (reviewing denial of

citizen petition denial). Here, by contrast, the FDA has taken no

adverse action whatsoever regarding the effect of delisting on Teva’s

ANDA—and apparently will not do so unless and until it denies final

approval. Had Teva raised the delisting issue before the FDA in the

first instance, its status here might be different.

review,” 182 F.3d at 979; upon the FDA’s issuance of an

adverse final order, Teva is free to seek judicial

review—forestalling generic competition and the loss of the

“first-mover advantage,” maj. op. at 15, through appropriate and

immediate injunctive relief.2

For the foregoing reasons, I would find the appeal is unripe

and dismiss it for lack of jurisdiction.3

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