Teva Pharmaceuticals, USA, Inc v. Kathleen Sebelius

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

2

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.

3

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 Hatch-

Waxman 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.

4

* * *

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.;

5

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

6

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

7

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

8

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

9

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

10

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 well-

established 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).

11

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

12

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

13

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

14

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,

15

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).

16

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 pre-

enforcement 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

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 drug-

approval 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

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.

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 pre-

enforcement 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 otherwise-

universally 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.

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 pre-

enforcement challenge to an agency interpretation adopted via

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

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.

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).

24

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,

25

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

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

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 parking-

prevention device, letting brand makers delist challenged

patents in order to trigger a forfeiture of exclusivity would be

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).

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

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.

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.

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.

2

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

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

3

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

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”).

4

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

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.