Mova Pharmaceutical Corp. v. Shalala

United States Court of Appeals

FOR THE DISTRICT OF COLUMBIA CIRCUIT

Argued March 13, 1998 Decided April 14, 1998

No. 97-5082

Mova Pharmaceutical Corp.,

Appellee

v.

Donna E. Shalala,

Secretary, U.S. Department of Health & Human Services and

Michael A. Friedman, Acting Commissioner, U.S. Food and
Drug Administration, Appellees

Mylan Pharmaceuticals, Inc.,

Appellant

Consolidated with

No. 97-5111

Appeals from the United States District Court

for the District of Columbia

(No. 96cv02861)

Steven Lieberman argued the cause for appellant Mylan
Pharmaceuticals, Inc., with whom E. Anthony Figg was on
the briefs.

Howard S. Scher, Attorney, United States Department of
Justice, argued the cause for the federal appellants, with
whom Frank W. Hunger, Assistant Attorney General, Mary
Lou Leary, United States Attorney at the time the briefs
were filed, and Douglas N. Letter, Litigation Counsel, were
on the briefs.

Steven J. Glassman argued the cause for appellant Phar-
macia & Upjohn Company, with whom David O. Bickart was
on the briefs.

Ronald L. Grudziecki argued the cause for appellee, with
whom James S. Rubin was on the brief.

John F. Cooney filed the brief for amicus curiae Teva
Pharmaceuticals, USA.

Before: Wald, Silberman and Tatel, Circuit Judges.

Opinion for the Court filed by Circuit Judge Wald.

Wald, Circuit Judge: On December 19, 1996, the Food and
Drug Administration ("FDA") approved an application by a
drug manufacturer, Mylan Pharmaceuticals, Inc. ("Mylan") to
market a generic version of micronized glyburide, a drug used
to treat diabetes. Another drug manufacturer, Mova Phar-
maceutical Corp. ("Mova"), had filed an earlier application to
market a generic version of the same drug; however, Mova's
application had not yet been approved, because of a patent
infringement suit brought by Pharmacia & Upjohn Company
("Upjohn"), in which Upjohn claimed that Mova's product
infringed a patent belonging to Upjohn.

When Mova learned that the FDA had approved Mylan's
application, it brought suit in the United States District Court
for the District of Columbia, relying on 21 U.S.C.
s 355(j)(5)(B)(iv) (1994),1 to compel the FDA to delay the

__________
1 At the time that Mova brought its action, this section was
designated 21 U.S.C. s 355(j)(4)(B)(iv). On November 21, 1997, the

effective date of this approval until 180 days after the earlier
of the dates that Mova won its suit or began to market its
product. Because the statutory scheme governing the ap-
proval of successive generic drug applications is quite com-
plex, we will, for purposes of the introduction, describe the
parties' contentions only in general terms. Mova argued
that, because it had filed a previous application to market a
generic version of micronized glyburide, the applicable statu-
tory provision, 21 U.S.C. s 355(j)(5)(B)(iv), granted a 180-day
market exclusivity period to Mova running from the date
Mova won its suit or began marketing its product, and the
FDA was barred from approving Mylan's similar application
until after the end of that 180-day period. In response, the
FDA cited a regulation that permitted the agency to approve
Mylan's application immediately, because at the time Mylan
submitted its application Mova had not yet "successfully
defended" against (that is, prevailed in) Upjohn's patent
infringement suit. See 21 C.F.R. s 314.107(c)(1). Mova in
turn challenged the FDA's regulation as inconsistent with the
plain language of s 355(j)(5)(B)(iv). The district court agreed
with Mova, and entered a preliminary injunction requiring
the FDA to delay its approval of Mylan's application until 180
days after Mova won its suit or began to market its product
(whichever came first). The FDA and Mylan have appealed
this decision.

While Mova's request for a preliminary injunction was
pending, Upjohn submitted a motion to intervene in the
litigation. After granting the injunction, the district court
denied Upjohn's motion to intervene, concluding that it was
moot, and that in any case Upjohn did not have a legally
protected interest in the subject matter of the litigation.

__________
Food and Drug Administration Modernization Act of 1997 was
enacted; section 119(b)(1)(A) of that law inserted a new section
355(j)(3), and redesignated former paragraphs 355(j)(3) to (8) as
paragraphs (4) to (9). See Pub. L. No. 105-115, 111 Stat. 2296
(1997). According to section 501 of that Act, the amendments "shall
take effect 90 days after the date of enactment of this Act." We
will therefore use the section's new designation.

Upjohn has appealed this ruling and its appeal has been
consolidated with that of the FDA and Mylan.

On the merits of the preliminary injunction, we find that
the district court was correct in finding that Mova was very
likely to be able to show that the FDA's regulation exceeded
its authority under the statute. On Upjohn's motion to
intervene, we find that the district court's reasons for denying
the motion were erroneous, and that Upjohn is entitled to
participate both in this appeal and in any further proceedings
before the district court.

I. Background

A.Statutory and Regulatory Framework

We will first briefly outline the statutory and regulatory
framework applicable to the marketing of generic drugs.
Generic drugs are versions of brand-name prescription drugs
that are often sold without a brand name and that contain the
same active ingredients, but not necessarily the same inactive
ingredients, as the original. United States v. Generix Drug
Corp., 460 U.S. 453, 455 (1983). Ordinarily, an applicant to
market a drug must complete a document called a New Drug
Application, or NDA. Preparing such applications can be a
time-consuming and costly process, as they must include data
from studies showing the drug's safety and effectiveness.
Formerly, a firm that wished to make a generic version of a
brand-name drug that had already been approved by the
FDA was required to file a new NDA, complete with new
studies showing the drug's safety and effectiveness. See
generally H.R. Rep. No. 98-857, Part I, at 16-17 (1984).

In 1984, Congress enacted the Hatch-Waxman Amend-
ments, which established a simplified procedure for FDA
approval of generic drugs. Under this procedure, the original
applicant for FDA approval of a drug, called the "pioneer"
applicant, must still complete a full NDA. However, subse-
quent applicants who wish to manufacture generic versions of
the original have an alternative: they may instead complete
an Abbreviated New Drug Application, or ANDA, which
relies on the FDA's previous determination that the drug is

safe and effective, and thus avoid submitting new safety and
effectiveness studies.

The Hatch-Waxman Amendments specify the contents of
an ANDA in detail. One requirement is that, for each of the
patents applicable to the pioneer drug, the ANDA applicant
must certify whether the proposed generic drug would in-
fringe that patent, and, if not, why not. The statute provides
ANDA applicants with four certification options: they may
certify (I) that the required patent information has not been
filed; (II) that the patent has expired; (III) that the patent
has not expired, but will expire on a particular date; or (IV)
that the patent is invalid or will not be infringed by the drug
for which the ANDA applicant seeks approval. 21 U.S.C.
s 355(j)(2)(A)(vii). We will call these paragraph I, II, III,
and IV certifications, respectively.

If the applicant makes a certification under paragraphs I or
II, the statute provides that the FDA may approve the
ANDA effective immediately. 21 U.S.C. s 355(j)(5)(B)(i). If
the applicant makes a certification under paragraph III, the
FDA may approve the ANDA effective on the date that the
applicant certifies that the patent will expire. 21 U.S.C.
s 355(j)(5)(B)(ii).

When an applicant makes a certification under paragraph
IV, things become more complicated. In such cases, the
statute begins by providing a forty-five-day window during
which the patent-holder may bring suit against the applicant.
If the patent-holder brings suit during that forty-five-day
period, the statute says that the FDA's approval of the
ANDA must be delayed for thirty months, a provision that is
presumably intended to allow the patent-holder time to vindi-
cate its patent in court before the generic competitor is
allowed entry into the market. 21 U.S.C. s 355(j)(5)(B)(iii).
The statute permits the court to lengthen or shorten this
period if it finds that either party has failed to "reasonably
cooperate in expediting the action." Id. If the court finds
that the patent is invalid or is not infringed, the FDA's
approval becomes effective as of the date of that ruling. 21

U.S.C. s 355(j)(5)(B)(iii)(I), (III).2

It is the succeeding provision of the statute, however, that
has occasioned the dispute involved in this suit (and many
others). That provision says:

__________
2 The full text of section 355(j)(5)(B)(iii) reads:

If the applicant made a certification described in subclause (IV)
of paragraph (2)(A)(vii), the approval shall be made effective
immediately unless an action is brought for infringement of a
patent which is the subject of the certification before the
expiration of forty-five days from the date the notice provided
under paragraph (2)(B)(i) is received. If such an action is
brought before the expiration of such days, the approval shall
be made effective upon the expiration of the thirty-month
period beginning on the date of the receipt of the notice
provided under paragraph (2)(B)(i) or such shorter or longer
period as the court may order because either party to the
action failed to reasonably cooperate in expediting the action,
except that--

(I) if before the expiration of such period the court decides
that such patent is invalid or not infringed, the approval shall
be made effective on the date of the court decision,

(II) if before the expiration of such period the court decides
that such patent has been infringed, the approval shall be made
effective on such date as the court orders under section
271(e)(4)(A) of Title 35 or

(III) if before the expiration of such period the court grants
a preliminary injunction prohibiting the applicant from engag-
ing in the commercial manufacture or sale of the drug until the
court decides the issues of patent validity and infringement and
if the court decides that such patent is invalid or not infringed,
the approval shall be made effective on the date of such court
decision.

In such an action, each of the parties shall reasonably cooper-
ate in expediting the action. Until the expiration of forty-five
days from the date the notice made under paragraph (2)(B)(i) is
received, no action may be brought under section 2201 of Title
28 for a declaratory judgment with respect to the patent. Any
action brought under section 2201 shall be brought in the
judicial district where the defendant has its principal place of
business or a regular and established place of business.

If the application contains a certification described in
subclause (IV) of paragraph (2)(A)(vii) and is for a drug
for which a previous application has been submitted
under this subsection continuing [sic] 3 such a certifica-
tion, the application shall be made effective not earlier
than one hundred and eighty days after--

(I) the date the Secretary receives notice from the
applicant under the previous application of the first
commercial marketing of the drug under the previous
application, or

(II) the date of a decision of a court in an action
described in clause (iii) holding the patent which is the
subject of the certification to be invalid or not infringed,
whichever is earlier.

21 U.S.C. s 355(j)(5)(B)(iv). This provision on its face ap-
pears to provide an advantage to the first party who files a
paragraph IV ANDA (henceforth, the "first applicant"), by
granting him a 180-day period in which to market his generic
drug without competition from other ANDA applicants.4 We
will call this Edenic moment of freedom from the pressures of
the marketplace the statute's "exclusivity period." Section
355(j)(5)(B)(iv) has two sub-clauses, each of which can trigger
the start of the 180-day exclusivity period; we will call sub-
clause (I), which turns on the first commercial marketing of
the drug, the "commercial-marketing trigger," and sub-clause
(II), which turns on a court decision finding the patent to be
invalid or not infringed, the "court-decision trigger."

The FDA, however, concluded, for reasons discussed below,
that Congress could not have intended for this provision to be
read literally. Thus, in drafting the regulations implementing

__________
3 This should probably read "containing."

4 The statute actually says that the exclusivity period applies
whenever there is a "previous" application; thus, the statute might
conceivably be read to confer this 180-day period on a second or
third applicant in some situations. For purposes of this litigation,
however, the only previous application is Mova's, which is also the
first. We will therefore refer only to the first applicant.

section 355(j)(5)(B)(iv), the FDA added its own requirement
that the first applicant must have "successfully defended
against a suit for patent infringement" before the exclusivity
period can begin to run. (We will refer to this as the
"successful defense" requirement.) The relevant regulation
states:

If an abbreviated new drug application contains a certifi-
cation that a relevant patent is invalid, unenforceable, or
will not be infringed and the application is for a generic
copy of the same listed drug for which one or more
substantially complete abbreviated new drug applications
were previously submitted containing a certification that
the same patent was invalid, unenforceable, or would not
be infringed and the applicant submitting the first appli-
cation has successfully defended against a suit for pat-
ent infringement brought within 45 days of the patent
owner's receipt of notice submitted under s 314.95, ap-
proval of the subsequent abbreviated new drug applica-
tion will be made effective no sooner than 180 days from
whichever of the following dates is earlier:

(i) The date the applicant submitting the first applica-
tion first commences commercial marketing of its drug
product; or

(ii) The date of a decision of the court holding the
relevant patent invalid, unenforceable, or not infringed.

21 C.F.R. s 314.107(c)(1) (emphasis added).

B.The Factual Scenario of This Case

Glyburide is a drug used in treating diabetes, and micron-
ized glyburide is one form of that drug. Upjohn holds a
patent for a particular formulation of micronized glyburide
entitled "Spray-Dried Lactose Formulation of Micronized
Glyburide."

In December, 1994, Mova filed an ANDA for a generic
form of micronized glyburide, which included a paragraph IV
certification. Mova gave the required notice to the patent-
holder, Upjohn; within 45 days of receiving this notice,

Upjohn filed a patent infringement suit against Mova in the
District of Puerto Rico.

While this litigation was underway, in November, 1995,
Mylan, too, filed an ANDA for a generic form of micronized
glyburide. Mylan's initial filing contained a paragraph III
certification; this meant that Mylan conceded patent infringe-
ment, so that its ANDA could not receive FDA approval until
Upjohn's patent expired. In August 1996, however, Mylan
amended its ANDA to contain a paragraph IV certification.

As Mova had, Mylan gave the required notice to Upjohn;
but this time Upjohn, for reasons unclear, failed to sue within
the prescribed 45-day period.5 The thirty-month suspension
of FDA approval provided for in section 355(j)(5)(B)(iii) only
applies if the patent-holder sues the ANDA applicant within
45 days; thus, this waiting period did not apply to Mylan.
And, because Mova had not yet "successfully defended"
against Upjohn's patent infringement suit, 21 C.F.R.
s 314.107(c)(1), which incorporates the FDA's interpretation
of section 355(j)(5)(B)(iv), did not require the FDA to delay its
approval of Mylan's ANDA. Thus, the FDA approved My-
lan's ANDA effective immediately, as of December 19, 1996.

After learning of this approval, Mova, on December 26,
1996, filed suit in the United States District Court for the
District of Columbia, seeking a temporary restraining order
compelling the FDA to postpone the effective date of Mylan's
approval. Although declining to issue a TRO, the district
court, on January 23, 1997, granted a preliminary injunction
requiring that the FDA render its approval of Mylan's ANDA
effective no earlier than 180 days after the earlier of (1)
Mova's first commercial marketing of its micronized glyburide
product, or (2) the date of Mova's victory in the Puerto Rico
litigation. (This was precisely the relief Mova had sought.)
In an accompanying memorandum, the district court ex-
plained that the successful-defense requirement in the FDA's
regulations was inconsistent with the plain language of sec-
tion 355(j)(5)(B)(iv), and therefore unenforceable. The FDA

__________
5 Upjohn did eventually sue Mylan, on February 17, 1997. On
March 31, 1998, the court ruled that Upjohn's patent was invalid
and not infringed.

and Mylan (which had intervened in the proceedings) appeal-
ed.

One further matter remained to be resolved. Before the
preliminary injunction was issued, Upjohn had filed a motion
seeking to intervene in the proceedings before the district
court. The district court had not adverted to this motion in
granting the preliminary injunction. A few days later, how-
ever, on February 10, it denied Upjohn's motion to intervene,
stating that the motion was moot (because the district court
had already issued the preliminary injunction), and also that
Upjohn did not have a "cognizable interest" in the litigation,
and was therefore not entitled to intervene. Upjohn has
appealed this order, and argues that it should be allowed to
participate in this appeal and in any further proceedings in
the district court.

While these appeals were pending, there have been subse-
quent developments in Upjohn's patent infringement suit
against Mova. On December 2, 1997, a jury found that
Upjohn's patent was invalid, unenforceable, and had not been
infringed. Mova received final approval from the FDA to
market its product on December 22, and began to sell its
product shortly afterwards. By its terms, the district court's
preliminary injunction will therefore expire 180 days after
December 2, 1997, on May 31, 1998.

II. Analysis

A.The Preliminary Injunction

To demonstrate entitlement to a preliminary injunction, a
litigant must show "1) a substantial likelihood of success on
the merits, 2) that it would suffer irreparable injury if the
injunction is not granted, 3) that an injunction would not
substantially injure other interested parties, and 4) that the
public interest would be furthered by the injunction." City-
fed Financial Corp. v. Office of Thrift Supervision, 58 F.3d
738, 746 (D.C. Cir. 1995). The district court balances the
litigant's showings in these four areas in deciding whether to
grant an injunction. Id. at 747. "We review a district court's
decision regarding a preliminary injunction for abuse of dis-

cretion, and any underlying legal conclusions de novo." Id. at
746.

Balancing these factors, the district court found, as to the
first, that Mova had a "very high" likelihood of success on the
merits, because Mova would probably be able to show that
the FDA's successful-defense requirement was contrary to
the plain language of section 355(j)(5)(B)(iv) and therefore
unenforceable. As to the second, the district court found that
"the earliest generic drug manufacturer in a specific market
has a distinct advantage over later entrants," and that Mova,
a small company, would find it extremely difficult to compete
against the much larger Mylan if Mylan got its product to
market first. As to the third prong, the district court found
that any harm to Mylan was small, because Mylan was so
likely to lose on the merits. And, as to the fourth, the district
court found that the public was the principal other interested
party, and that the public's interest in the "faithful application
of the laws" outweighed its interest in immediate access to
Mylan's generic product.

The FDA and Mylan have not seriously contested the
district court's findings as to the second, third and fourth
factors.6 However, they both vigorously contest the district
court's conclusion that the successful-defense requirement is

__________
6 The FDA notes that "the mere existence of competition is not
irreparable harm, in the absence of substantiation of severe eco-
nomic impact." WMATA v. Holiday Tours, 559 F.2d 841, 843 n.3
(D.C. Cir. 1977). Here, however, the district court found that Mova
would be harmed by the loss of its "officially sanctioned head start,"
and that Mova's small size put it at a particular disadvantage. This
suffices to show a severe economic impact to Mova.

Both the FDA and Mylan also contend that the district court
should have declined to issue a preliminary injunction in order to
further the public's interest in the rapid movement of generic drugs
into the marketplace. Supposing that they are right in their
assessment of the public's interest, however, this factor alone
cannot support denying an injunction. Our polity would be very
different indeed if the courts could decline to enforce clear laws
merely because they thought them contrary to the public interest;
we decline to embark upon that path.

inconsistent with section 355(j)(5)(B)(iv). We will focus on
the FDA's arguments, because it is on an agency's own
justifications that the validity of its regulations must stand or
fall. See SEC v. Chenery Corp., 318 U.S. 80 (1943).

The FDA concedes that the text of section 355(j)(5)(B)(iv)
makes no provision for a successful-defense requirement. It
asserts, however, that a literal reading of that statutory
provision would produce consequences of a kind Congress
could not have intended when it wrote the law, and that its
interpolation of a successful-defense requirement is an appro-
priate way of implementing Congress's underlying intent.

The FDA points to two principal situations in which a
literal reading of the statute would produce bizarre results:
(1) cases in which the first applicant is never sued, and (2)
cases in which the first applicant loses its suit. If the first
applicant is never sued, the FDA claims, then the court-
decision trigger will never be satisfied. Later ANDA appli-
cants will be unable to market their products until the first
applicant decides to put its product on the market, thereby
satisfying the commercial-marketing trigger. But the first
applicant could in theory wait indefinitely to begin selling its
product, and thereby block all sales by later applicants. This
unfortunate scenario could happen, for instance, if the first
applicant colludes with the pioneer drug company to eliminate
generic competition, or if the first applicant is simply unable
to obtain FDA approval of its production facilities and so
cannot put its product on the market.

If the first applicant loses its infringement suit, the delay
problem could be even more serious. The first applicant
would then be able to satisfy neither the court-decision trig-
ger nor the commercial-marketing trigger (because, having
lost a patent-infringement suit, it would be unable to sell its
product). Thus, the FDA claims, no generic drugs could
enter the market until after the pioneer company's patent
expired.

The successful-defense requirement, according to the FDA,
is calculated to eliminate both occurrences. An applicant that
is never sued or that loses its suit will not have "successfully

defended against a suit for patent infringement," 21 C.F.R.
s 314.107(c)(1), and so the exclusivity period will not apply.
Such applicants will therefore not interfere with the orderly
movement by successive applicants of generic drugs into the
marketplace.

1. Applicable Principles of Judicial Review

In assessing the validity of an agency's interpretation of a
statute, we begin by asking whether "Congress has directly
spoken to the precise question at issue"; if so, "the court, as
well as the agency, must give effect to the unambiguously
expressed intent of Congress." Chevron U.S.A. Inc. v. Natu-
ral Resources Defense Council, Inc., 467 U.S. 837, 842-43
(1984). If we find that "the statute is silent or ambiguous
with respect to the specific issue, the question for the court is
whether the agency's answer is based on a permissible con-
struction of the statute." Id. at 843.

In the district court's judgment, the FDA's pragmatic
reading of the statute could not survive the first prong of
Chevron. Concluding that the language of the statute "may
be complex, and even cumbersome, but it is plain and unam-
biguous," and that the statute "does not include a 'successful
defense' requirement, and indeed it does not even require the
institution of patent litigation," the district court found that,
under the plain language of the statute, if a paragraph IV
ANDA has been filed by a prior applicant, the FDA must
delay approval of all subsequent ANDAs until either the
court-decision trigger or the commercial-marketing trigger is
satisfied.

We think that the district court achieved the right result,
but we are not quite as sanguine as the district court that, in
applying the first prong of Chevron, it suffices to look only at
the plain language of the statute. "[I]n expounding a statute,
we must not be guided by a single sentence or member of a
sentence, but look to the provisions of the whole law, and to
its object and policy." Pilot Life Insurance Co. v. Dedeaux,
481 U.S. 41, 51 (1987); see also McCarthy v. Bronson, 500
U.S. 136, 139 (1991). Here, the FDA cannot point to any
particular ambiguity in the words of section 355(j)(5)(B)(iv)

that permits it to interpolate its "successful defense" require-
ment. Instead, the FDA's argument is that a literal reading
of the statute would thwart Congress's central goal, in enact-
ing the Hatch-Waxman Amendments, to bring generic drugs
onto the market as rapidly as possible.

In effect, the FDA seeks to invoke the long-standing rule
that a statute should not be construed to produce an absurd
result. "It is a familiar rule, that a thing may be within the
letter of the statute and yet not within the statute, because
not within its spirit nor within the intention of its makers....
If a literal construction of the words of a statute be absurd,
the act must be so construed as to avoid the absurdity."
Holy Trinity Church v. United States, 143 U.S. 457, 459-60
(1892); see also United States v. X-Citement Video, Inc., 513
U.S. 64, 68-69 (1994) (rejecting the "most natural grammati-
cal reading" of a statute to avoid "absurd" results); Green v.
Bock Laundry Machine Company, 490 U.S. 504, 527, 527-29
(1989) (Scalia, J., concurring); In re Nofziger, 925 F.2d 428,
434 (D.C. Cir. 1991); Veronica M. Dougherty, Absurdity and
the Limits of Literalism, 44 Am. U.L. Rev. 127 (1994). Over a
hundred years ago, the Court explained this rule thus:

The common sense of man approves the judgment men-
tioned by Puffendorf, that the Bolognian law which en-
acted "that whoever drew blood on the streets should be
punished with the utmost severity," did not extend to the
surgeon who opened the vein of a person who fell down
on the street in a fit. The same common sense accepts
the ruling, cited by Plowden, that the statute of 1st
Edward II, which enacts that a prisoner who breaks
prison shall be guilty of a felony, does not extend to a
prisoner who breaks out when the prison is on fire--"for
he is not to be hanged because he would not stay to be
burnt."

United States v. Kirby, 74 U.S. (7 Wall.) 482, 487 (1868)
(citations omitted).

In deciding whether a result is absurd, we consider not
only whether that result is contrary to common sense, but
also whether it is inconsistent with the clear intentions of the

statute's drafters--that is, whether the result is absurd when
considered in the particular statutory context. If " 'the literal
application of a statute will produce a result demonstrably at
odds with the intentions of its drafters,' ... the intention of
the drafters, rather than the strict language, controls." Unit-
ed States v. Ron Pair Enterprises, 489 U.S. 235, 242 (1989)
(quoting Griffin v. Oceanic Contractors, Inc., 458 U.S. 564,
571 (1982)); see also Environmental Defense Fund, Inc. v.
EPA, 82 F.3d 451, 468 (D.C. Cir. 1996) (applying Ron Pair ).

The rule that statutes are to be read to avoid absurd
results allows an agency to establish that seemingly clear
statutory language does not reflect the "unambiguously ex-
pressed intent of Congress," Chevron, 467 U.S. at 842, and
thus to overcome the first step of the Chevron analysis. But
the agency does not thereby obtain a license to rewrite the
statute. When the agency concludes that a literal reading of
a statute would thwart the purposes of Congress, it may
deviate no further from the statute than is needed to protect
congressional intent. Of course, the agency might be able to
show that there are multiple ways of avoiding a statutory
anomaly, all equally consistent with the intentions of the
statute's drafters (and equally inconsistent with the statute's
text). In such a case, we would move to the second stage of
the Chevron analysis, and ask whether the agency's choice
between these options was "based on a permissible construc-
tion of the statute." Id. at 843. Otherwise, however, our
review of the agency's deviation from the statutory text will
occur under the first step of the Chevron analysis, in which
we do not defer to the agency's interpretation of the statute.

Here, we think that the FDA's interpretation cannot sur-
vive analysis under the first step of Chevron. The FDA's
"successful defense" requirement achieves the FDA's stated
goal of preventing first applicants who are not sued or who
lose their suits from benefiting from the exclusivity period.
But it also does more. The FDA had two routes by which it
could have addressed the problem of first applicants who lose
their suits, which we will call the "wait-and-see" approach and
the "win-first" approach. Under the wait-and-see option,
later applicants would need to wait to see whether the first

applicant won or lost its patent infringement suit. If the first
applicant lost, the exclusivity period would not apply; if he
won, it would.7 The FDA chose the other option, the win-
first approach. Under this approach, later applicants do not
need to wait to see whether the first applicant wins or loses.
Instead, while the first applicant's litigation is underway, the
FDA may approve the applications of later ANDA applicants
effective immediately, if they are otherwise eligible for ap-
proval.8 Thus, the first applicant must win its lawsuit before
section 355(j)(5)(B)(iv) has any effect on subsequent appli-
cants at all.

It is the FDA's decision to adopt the win-first approach
that led to the present litigation. If the FDA had instead
chosen the wait-and-see approach, the FDA could not have
approved Mylan's application when it did; instead, Mylan
would have needed to wait for the end of Mova's patent
infringement suit. We will therefore focus on this aspect of
the successful-defense requirement.

We conclude that the FDA's successful-defense require-
ment is inconsistent with the unambiguously expressed intent
of Congress. The rule is gravely inconsistent with the text
and structure of the statute. Nor can the FDA show that the
successful-defense requirement is needed to avoid "a result
demonstrably at odds with the intentions of [section
355(j)(5)(B)(iv)'s] drafters." Ron Pair Enterprises, 489 U.S.
at 242. The FDA could have adopted a more narrow solution
to the problem of first applicants who are never sued or who
lose their suits. It instead adopted the broad win-first rule,
which it cannot show is needed to implement congressional
intent. In effect, the FDA has embarked upon an adventur-
ous transplant operation in response to blemishes in the

__________
7 We do not mean to foreclose a third possibility, which is that
some lawsuit other than that against the first applicant might
satisfy the court-decision trigger before the first applicant's suit is
over. We discuss this possibility below.

8 That is, if they have not been sued by the patent-holder, and are
therefore not subject to the 30-month waiting period, or if the 30-
month period has expired.

statute that could have been alleviated with more modest
corrective surgery.

2. The Statute's Text and Structure

Section 355(j)(5)(B)(iv) is far from a model of legislative
draftsmanship. The district court in this case called the
provision "cumbersome"; another district court described it
as "very confusing and ambiguous." Mylan Pharmaceuti-
cals, Inc. v. Sullivan, No. 89-36-C(K), slip op. at 6 (N.D.W.V.
May 5, 1989). But, to the extent that the statute is clear
about anything, it clearly forecloses the FDA's successful-
defense requirement.9

The successful-defense requirement is inconsistent with the
literal language of the statute. Section 355(j)(5)(B)(iv) says
that, if an applicant has already filed a paragraph IV ANDA,
later applications shall be approved "not earlier than one
hundred and eighty days after" the commercial-marketing
trigger or the court-decision trigger is satisfied. The FDA's
successful-defense requirement, by contrast, permits later
applications to be approved even though neither trigger has
been satisfied, simply because the first applicant's litigation
has not yet come to a successful conclusion.

The win-first rule also infringes on the statutory scheme in
a second, subtler way: its practical effect is to write the
commercial-marketing trigger out of the statute. The com-
mercial-marketing trigger seems intended to ensure that, if a
first ANDA applicant chooses to begin marketing its product
before it has won its patent-infringement suit, the 180-day
exclusivity period will begin to run immediately. Under the
FDA's regulation, however, the 180-day exclusivity period is
only available to an applicant who has already "successfully
defended against a suit for patent infringement." Thus, if the
first applicant begins marketing its product before it wins its

__________
9 We note that the Fourth Circuit recently came to the same
conclusion in an unpublished opinion. See Granutec, Inc. v. Shala-
la, Nos. 97-1873, 97-1874, slip op. at 13-14 (4th Cir. Apr. 3, 1998).
Because the rules of the Fourth Circuit disfavor (but do not
prohibit) citation of unpublished opinions, we will not discuss the
reasoning of Granutec further.

infringement suit, the 180 days of exclusivity do not begin to
run; other applicants remain eligible for FDA approval to
begin marketing their products, at least up to the date that
the first applicant wins the infringement action.

If the first applicant eventually wins its lawsuit, the exclu-
sivity period is counted as though it had begun to run when
the applicant started commercial marketing. Thus, an appli-
cant who begins commercial marketing 120 days before win-
ning its lawsuit receives only 60 days of exclusivity; an
applicant who begins commercial marketing 180 days (or
more) before winning its suit receives no exclusivity period at
all. The FDA thus construes the commercial-marketing trig-
ger to potentially hurt, but never benefit, the first ANDA
applicant.

There is no indication in the text or history of section
355(j)(5)(B)(iv) that the commercial-marketing trigger is sup-
posed to function in that one-sided manner. The FDA itself
provided a more plausible explanation of how it should work
in an initial notice of proposed rulemaking for the ANDA
regulations. As the FDA then explained the statutory
scheme,

Congress's decision to begin the 180-day period under
section 505(j)(4)(B)(iv)(I) of the act from "the first com-
mercial marketing of the drug," rather than from the
effective date of the ANDA, serves a rational policy only
if Congress contemplated a situation in which an approv-
al of an ANDA is in effect but the applicant's decision not
to market the drug deserves to be protected because a
delay in marketing serves the public interest.

Such a situation occurs where, under the terms of
section 505(j)(4)(B)(iii) of the act, an ANDA goes into
effect 30 months after a lawsuit is filed, but the lawsuit is
still pending. It serves the public interest to permit a
prudent ANDA holder in that situation to stay off the
market until the litigation is resolved, thereby minimiz-
ing potential damages.

As drafted, sections 505(j)(4)(B)(iv)(I) and (II) of the
act carefully avoid providing an incentive for immediate
marketing; the 180-day reward of exclusive marketing
begins when the applicant wins the lawsuit or when the

applicant actually begins marketing, "whichever is earli-
er." The applicant thus does not lose any of the 180-day
period by electing to stay off the market until the lawsuit
is over.

Abbreviated New Drug Application Regulations, 54 Fed. Reg.
28,872, 28,894 (1989). In other words, the 180-day exclusivity
period should begin to run as soon as the first applicant
begins commercial marketing. In adopting the successful-
defense requirement in its final rulemaking, the FDA neither
rejected the foregoing analysis, nor explained how the suc-
cessful-defense requirement would be consistent with it. See
Abbreviated New Drug Application Regulations, 59 Fed. Reg.
50,338, 50,353 (1994).10

3. Does a Literal Reading Produce Absurd Results?

The FDA contends that the statute should not be read
literally, because such a reading would produce results that
are clearly inconsistent with the intent of Congress in enact-
ing the statute. We do not think that it is sufficiently clear
that Congress intended the "win-first" reading of the statute
to justify disregarding the most natural reading of the statu-
tory text.

We begin by setting aside the problems of the first appli-
cant who is never sued or who loses his lawsuit. The FDA
may or may not be right that a literal reading of the statute
to permit a first applicant to receive an exclusivity period in
these situations would be inconsistent with the statutory
scheme; we do not decide this question. As we have already
pointed out, the fatal flaw in the FDA's "absurd results"
argument is that the agency could have addressed these two
(supposedly) problematic situations without imposing the
broad win-first rule by creating narrower exceptions to sec-

__________
10 The FDA said only that "[o]ne comment said the rule, as
drafted, created an incentive for frivolous claims of patent invalidity
or noninfringement because it would give ANDA applicants exclu-
sivity even if the applicant was unsuccessful in defending against
the patent owner's lawsuit. The comment would replace the phrase
'to be sued within 45 days' with 'and to successfully defend a suit
brought within 45 days.' The FDA agrees and has amended
s 314.107(c) accordingly." Abbreviated New Drug Application
Regulations, 59 Fed. Reg. 50,338, 50,353 (1994).

tion 355(j)(5)(B)(iv) for the "no suit" and "lost suit" cases.
Indeed, the FDA has come close to doing so already. As for
first applicants who are never sued, the initial draft of 21
C.F.R. s 314.107(c)(1) contained, instead of the successful-
defense requirement, only a requirement that the first appli-
cant have been "sued for patent infringement within 45 days
of the patent owner's receipt of notice" in order to be eligible
for the statutory period. Abbreviated New Drug Application
Regulations, 54 Fed. Reg. 28,872, 28,929 (1989). This lan-
guage would have corrected the problem of first applicants
who are never sued (and only that problem).11

As to first applicants who lose their suits, Mova observed at
oral argument that one of the FDA's current regulations
suggests a possible way of addressing this problem (and
indeed may already have solved it). That regulation provides
that, if an ANDA applicant who makes a certification under
paragraph IV later loses its patent-infringement suit, it must
amend its ANDA to make a new certification under para-
graph III, and provides that the ANDA will then "no longer
be considered to be one containing a certification under
paragraph [IV]." 12 The FDA claims that the regulation does

__________
11 Even this may not be the narrowest way of resolving the
underlying problem. After all, Congress may have intended to
reward the first ANDA applicant for his enterprise whether or not
he is later sued; the statutory scheme only runs into problems if
the first applicant never starts selling his product. An alternative
might be to prescribe a period within which a first applicant who
has not been sued must bring his product to market in order to
benefit from the exclusivity period.

12 The relevant regulation provides:

An applicant who has submitted a certification under para-
graph (a)(12)(i)(A)(4) of this section and is sued for patent
infringement within 45 days of the receipt of notice sent under
s 314.95 shall amend the certification if a final judgment in the
action against the applicant is entered finding the patent to be
infringed. In the amended certification, the applicant shall
certify under paragraph (a)(12)(i)(A)(3) of this section that the
patent will expire on a specific date. Once an amendment or
letter for the change has been submitted, the application will no

not have the effect of rendering the exclusivity period inappli-
cable after such an amendment, and of course we owe defer-
ence to the agency on the interpretation of its own regula-
tions.13 But even if the present version of the regulation does
not accomplish the desired end, the FDA could presumably
draft a regulation that did so.

The FDA did not choose to adopt these narrower ap-
proaches; instead, it adopted the "win-first" reading of the
statute, which deviated from the literal language of the
statute by allowing an application to be approved while the
first applicant's lawsuit was pending and before either statu-
tory trigger had been satisfied. In analyzing the successful-
defense requirement, then, we must ask whether the win-first
reading is needed to avoid "a result demonstrably at odds
with the intentions of [section 355(j)(5)(B)(iv)'s] drafters."
Ron Pair Enterprises, 489 U.S. at 242.

The FDA did not explain its decision to adopt the win-first
approach (instead of a narrower approach) in issuing its
regulation, see 59 Fed. Reg. 50,338, 50,353 (1994), and it has
not presented any argument for that approach in this litiga-
tion. There is, however, a compelling argument for the win-
first approach, which is advanced by Mylan. What if the first

__________
longer be considered to be one containing a certification under
paragraph (a)(12)(i)(A)(4) of this section. If a final judgment
finds the patent to be invalid and infringed, an amended
certification is not required.

21 C.F.R. s 314.94(a)(12)(viii)(A).

13 The FDA said at oral argument that its regulation is intended
only for "housekeeping" purposes, and that it should not be read to
affect the application of section 355(j)(5)(B)(iv). We owe "substan-
tial deference" to an interpretation by the FDA of its own regula-
tions, which has "controlling weight unless it is plainly erroneous or
inconsistent with the regulation." S.G. Loewendick & Sons, Inc. v.
Reich, 70 F.3d 1291, 1294 (D.C. Cir. 1995) (quoting Thomas Jeffer-
son Univ. v. Shalala, 512 U.S. 504, 512 (1994)). We confess to not
understanding how the FDA can reconcile its reading with the
language of its own regulation, but stress that this issue has not
been briefed and is not necessary to the decision in this case.

applicant does a poor job of designing its product to avoid
infringing the patent-holder's patent, and the second appli-
cant does a much better job? The first applicant would then
be sued for infringement by the patent-holder, but the second
applicant would not. Indeed, this is exactly what Mylan
claims happened in the present case (although Mova vigorous-
ly contests this claim).

In such a situation, a literal reading of the statute admit-
tedly produces a strange result. The second applicant, even
though it has designed its product well and avoided suit, is
barred from selling its product until the first applicant's
lawsuit finishes (maybe years later). The ingenious second
applicant is thus harmed, and the public is deprived of the
fruits of its ingenuity--a result seemingly at odds with Con-
gress's apparent purposes, in enacting section 355(j)(5)(B)(iv),
of rewarding innovation and bringing generic drugs to market
quickly. Indeed, the first applicant could even collude with
the original patent-holder to prolong their litigation, and
thereby keep the second applicant's drug off the market
indefinitely.14

Yet we are not persuaded that this third anomaly suffices
to show that a literal reading of the statute leads to results
manifestly inconsistent with the intent of Congress. The
legislative history of section 355(j)(5)(B)(iv) is limited, and
fails utterly to specify or even provide any signals as to
whether Congress intended that a second ANDA applicant
who was not sued for patent infringement would have to wait
until one of the statutory triggers was satisfied, or instead be

__________
14 An amicus brief filed by Biovail Corporation International
dramatically illustrates an analogous risk, not necessarily involving
collusion. Biovail was the second applicant to file a paragraph IV
ANDA for a generic version of a heart medication. Biovail was not
sued by the pioneer drug company. The first applicant and the
pioneer drug company are now in litigation, and, Biovail claims, the
pioneer is paying the first applicant some $10 million per quarter in
exchange for the first applicant's agreement not to sell its product
after the 30-month waiting period expires. Under these circum-
stances, neither party would seem to have maximum incentive to
bring the litigation to a close.

able to immediately market its product. Congress may very
well never even have thought about this question. But it is
not inconceivable that Congress meant what the statute says,
i.e., that the second applicant would have to wait for the first
lawsuit to finish. The fact that a patent-holder fails to sue an
ANDA applicant does not necessarily mean that it has con-
cluded that the applicant did a good job of designing around
its patent. The patent-holder might have simply made a
mistake, and negligently failed to file suit (or filed a few days
after the end of the 45-day window). If a second ANDA
applicant who is not sued by the patent-holder is allowed to
immediately market its product, then the patent-holder's
error will have unfairly deprived the first applicant of the
benefits of the exclusivity period. Moreover, even if the
second applicant is sued, the successful-defense requirement
will allow him to receive FDA approval immediately once the
30-month waiting period expires. Given the nature of litiga-
tion, the first applicant's patent-infringement suit could easily
take longer than thirty months. The successful-defense re-
quirement may therefore have the effect of allowing many
ANDA applicants to sell their products without regard to the
exclusivity period, a result that Congress might not have
intended.15

Additionally, there may be other ways in which a second
applicant with a better product can bring that product to
market before the first lawsuit terminates. Amicus curiae,
Teva Pharmaceutical Inc. ("Teva"), has pointed to one possi-
bility. Teva observes that the court-decision trigger, by its
terms, can be satisfied by any "decision of a court in an action
described in clause (iii) holding the patent which is the
subject of the certification to be invalid or not infringed."
Teva claims that the actions "described in clause (iii)" are not

__________
15 Under the FDA's regulation, once a later applicant's drug has
been approved, it will apparently remain on the market even if the
exclusivity period later begins to run. The regulation only applies
the 180-day exclusivity period to ANDAs that are "subsequent" to a
successful defense by the first applicant, 21 C.F.R. s 314.107(c)(1),
and an ANDA that has already been approved does not fall in this
category.

limited to infringement suits by the patent-holder, because
the last two sentences of clause (iii) say:

Until the expiration of forty-five days from the date the
notice made under paragraph (2)(B)(i) is received, no
action may be brought under section 2201 of Title 28 for
a declaratory judgment with respect to the patent. Any
action brought under section 2201 shall be brought in the
judicial district where the defendant has its principal
place of business or a regular and established place of
business.

21 U.S.C. s 355(j)(5)(B)(iii). Thus, Teva says, a declaratory
judgment action provides an alternative way of satisfying the
court-decision trigger. An ANDA applicant who doesn't want
to wait for the first applicant's patent infringement litigation
to finish can bring its own declaratory judgment action
against the patent-holder, and, if the second applicant pre-
vails, the court-decision trigger will be satisfied, and it will be
allowed to market its product.

Teva's argument is elegant and textually persuasive. It
also provides a particularly appropriate solution in cases in
which the second applicant has done a better job of designing
around the pioneer drug manufacturer's patent than the first
did: in such cases, the second applicant should find it (rela-
tively) easy to win a declaratory judgment action against the
patent-holder. Teva's reading thus rewards those applicants
(and only those applicants) who have built a better mouse-
trap.

Teva's reading is not, however, flawless. One difficulty is
that the 180-day exclusivity period will seemingly always go
to the first applicant, no matter whose suit satisfies the court-
decision trigger; the statute provides that any applications
after the first one "shall be made effective not earlier than
one hundred and eighty days after" the court-decision trigger
is satisfied. 21 U.S.C. s 355(j)(5)(B)(iv).16 It seems odd to
reward the first applicant if some later applicant was the

__________
16 This is the most natural reading of the statute, but we do not
necessarily find that it is the only permissible reading.

party that actually prevailed in the patent-infringement litiga-
tion.17

Mylan has also noted what may be a more serious fly in the
(patented) ointment. In order to satisfy the Constitution's
case or controversy requirement, a party filing a declaratory
judgment action must show that there is a controversy of
"sufficient immediacy and reality to warrant the issuance of a
declaratory judgment." Federal Express Corp. v. Air Line
Pilots Ass'n, 67 F.3d 961, 964 (D.C. Cir. 1995) (quoting
Maryland Casualty Co. v. Pacific Coal & Oil Co., 312 U.S.
270 (1941)). To employ Teva's declaratory-judgment device,
a party would therefore need to demonstrate a "reasonable
apprehension of facing a lawsuit." Federal Express Corp., 67
F.3d at 964. The Federal Circuit has exclusive jurisdiction
over appeals in actions for patent infringement. 28 U.S.C.
s 1292(c). Under the Federal Circuit's caselaw, a declarato-
ry judgment plaintiff must be able to point to some conduct
by the patent-holder that suggests that the plaintiff is at risk
of being sued; the fact that the patent-holder has sued others
is "pertinent," but "not always conclusive." See West Interac-
tive Corp. v. First Data Resources, 972 F.2d 1295, 1297-98
(Fed. Cir. 1992). An ANDA applicant seeking to bring a
declaratory judgment action might have difficulty in meeting
this test, especially if the patent-holder disclaims any inten-
tion of bringing suit.18

__________
17 Indeed, the first applicant may still be enmeshed in patent-
infringement litigation when the 180-day period begins, and there-
fore be unable to take advantage of the exclusivity period.

18 One way of eliminating strategic behavior of this kind might be
for the FDA to provide by regulation that a court decision ruling
that an ANDA applicant cannot reasonably anticipate suit by a
patent-holder is equivalent, for purposes of section 355(j)(5)(B)(iv),
to a ruling that the patent is invalid or not infringed. After all, the
purpose of the scheme set up by section 355(j)(5)(B) is to allow the
patent-holder an opportunity to defend its patent. If the patent-
holder declines even to create enough adversity to support a
declaratory judgment action, it might well be fair to deem the
patent-holder to have conceded noninfringement, at least for pur-
poses of the statutory scheme. Certainly, there would be no danger

The problem of the meritorious second applicant is a real
one, but the successful-defense requirement is too blunt an
instrument to solve it. The requirement cannot be reconciled
with the literal language of the statute, and alters the statuto-
ry scheme in a number of ways that do not clearly serve
congressional intent. We do not, of course, foreclose the
FDA from attempting to address the problem of the meritori-
ous second applicant in some narrower way, as long as that
solution conforms to the statute. For now, however, we are
presented with the successful-defense requirement, and we
uphold the district court's decision to enjoin the FDA's en-
forcement of that requirement.

B.Upjohn's Motion to Intervene

We now turn to Upjohn's appeal of the district court's
denial of its motion to intervene. The district court denied
Upjohn's motion on two grounds: first, that Upjohn's motion
was mooted by the grant of the preliminary injunction, and
second, that s 355(j)(5)(B)(iv) "does not provide a cognizable
interest upon which a pioneer patent owner or an NDA owner
can challenge the approval of an ANDA." We find that the
district court was in error on both grounds.

A motion to intervene as of right turns on four factors: (1)
the timeliness of the motion; (2) whether the applicant
"claims an interest relating to the property or transaction
which is the subject of the action," Fed. R. Civ. P. 24(a); (3)
whether "the applicant is so situated that the disposition of

__________
in such a case that the patent-holder's failure to enforce its patent is
attributable to a mistake.

Moreover, the Federal Circuit has had no occasion to decide
whether there is "a controversy of sufficient immediacy and reality"
to support a declaratory judgment action, Federal Express Corp., 67
F.3d at 964, when the plaintiff requires a judgment under section
355(j)(5)(B) in order to bring its product to market. It is possible
that such a statutorily-created bottleneck, coupled with the statute's
express reference to declaratory judgment actions as a means of
relieving that bottleneck, might suffice to allow a plaintiff to show
the existence of a "case or controversy" without demonstrating an
immediate risk of being sued.

the action may as a practical matter impair or impede the
applicant's ability to protect that interest," id.; and (4) wheth-
er "the applicant's interest is adequately represented by
existing parties." Id. To the extent that a district court's
ruling on a motion to intervene as of right is based on
questions of law, it is reviewed de novo; to the extent that it
is based on questions of fact, it is ordinarily reviewed for
abuse of discretion. See Massachusetts School of Law at
Andover, Inc. v. United States, 118 F.3d 776, 779-80 (D.C.
Cir. 1997) (noting, however, that application of the abuse-of-
discretion standard seems anomalous in some circumstances).
The issues that Upjohn raises on its appeal are all pure
questions of law, so we apply de novo review.

The district court erred in finding that Upjohn's motion to
intervene was moot. The district court had entered only a
preliminary injunction, not a permanent injunction. The
district court presumably would have considered new evi-
dence or new arguments in future proceedings, had Upjohn
(or some other party) wished to present them. And interven-
ing even after the injunction had been issued would have
allowed Upjohn to participate in the appeal of the injunction.
See Massachusetts School of Law at Andover, 118 F.3d at 779
(discussing intervention before the district court for purposes
of appeal).

The district court was also in error in finding that Upjohn
did not "claim[ ] an interest relating to the property or the
transaction which is the subject of the action," as is required
by Federal Rule of Civil Procedure 24(a)(2). Rule 24(a)
"impliedly refers not to any interest the applicant can put
forward, but only to a legally protectable one." Southern
Christian Leadership Conference v. Kelley, 747 F.2d 777, 779
(D.C. Cir. 1984). Thus, a party that seeks to intervene as of
right must demonstrate that it has standing to participate in
the action. See id. There is no dispute that Upjohn has
constitutional standing; numerous cases have found that a
firm has constitutional standing to challenge a competitor's
entry into its market. See, e.g., Association of Data Process-
ing Serv. Orgs., Inc. v. Camp, 397 U.S. 150, 152 (1970) ("Data
Processing ").

Mylan argues, however, that Upjohn is not within the "zone
of interests" of section 355(j)(5)(B)(iv), and that it therefore
lacks prudential standing. We do not agree. The first step
in the prudential standing analysis is to identify the interests
protected by the statute. To do so, we consider the purposes
of the specific statutory provision that is at issue (here,
section 355(j)(5)(B)(iv)), read in the context of the statutory
scheme as a whole. See Bennett v. Spear, 117 S. Ct. 1154,
1167 (1997); Clarke v. Securities Industry Assoc., 479 U.S.
388, 401 (1987) (stating that a court is "not limited to consid-
ering the statute under which respondents sued, but may
consider any provision that helps us to understand
Congress's overall purposes...."). The purpose of section
355(j)(5)(B)(iv) is to provide a reward, in the form of an
exclusivity period, to generic drug companies that are the
first to file paragraph IV ANDAs. Section 355(j)(5)(B)(iv) is
not intended to benefit pioneer drug companies directly.
Indeed, quite the opposite is true: the provision is intended
to reward generic drug manufacturers who challenge pioneer
drug companies' patents. Thus, in the nomenclature of this
circuit's caselaw, Upjohn cannot show that it is an "intended
beneficiary" of section 355(j)(5)(B)(iv). Scheduled Airlines
Traffic Offices, Inc. v. Dept. of Defense, 87 F.3d 1356, 1359
(D.C. Cir. 1996) ("Scheduled Airlines").

But a plaintiff can be within the zone of interests of a
statute even in the absence of "an indication of congressional
purpose to benefit the would-be plaintiff." Clarke, 479 U.S.
at 399-400. As the Court recently made clear in National
Credit Union Administration v. First National Bank &
Trust Co., 118 S. Ct. 927 (1998) ("NCUA "), a plaintiff only
needs to show that its interest is among those "arguably ...
to be protected" by the statute. Id. at 935 (quoting Data
Processing, 397 U.S. at 153) (emphasis added). This analysis
focuses, not on those who Congress intended to benefit, but
on those who in practice can be expected to police the
interests that the statute protects. In NCUA, the provision
before the Court imposed a rule called the "common bond
requirement," which limits the membership of credit unions
to "groups having a common bond of occupation or associa-

tion." 12 U.S.C. s 1759 (1994). The question for the Court
was whether a group of banks who had an interest in limiting
the markets that credit unions could serve were within the
zone of interests of this provision. The Court found that the
common bond requirement was intended to "reinforce the
cooperative nature of credit unions, which in turn was be-
lieved to promote their safety and soundness and allow access
to credit by persons otherwise unable to borrow." NCUA,
118 S. Ct. at 935 n.6. The Court reasoned that "by its very
nature, a cooperative institution must serve a limited mar-
ket," id., so that there is an "unmistakable" link between the
statute and a "limitation on the markets that federal credit
unions can serve." Id. at 935 & n.6. The Court concluded
that limiting the markets served by credit unions is therefore
an interest "arguably to be protected" by the statute, so that
the banks had prudential standing.

The test applied by NCUA is not far removed from this
circuit's "suitable challenger" test. See, e.g., Scheduled Air-
lines, 87 F.3d at 1359-61 (applying this test). Under the
"suitable challenger" test, a plaintiff must demonstrate that
its "interests are sufficiently congruent with those of the
intended beneficiaries that the litigants are not 'more likely to
frustrate than to further ... statutory objectives.' " Id. at
1359 (quoting First Nat'l Bank & Trust Co. v. National
Credit Union Admin., 988 F.2d 1272, 1275 (D.C. Cir. 1993)
(quoting Clarke, 479 U.S. at 397 n.12)). NCUA allows a
plaintiff to demonstrate that its interest and the interest
served by the statute have, by their "very nature," an "unmis-
takable" link. NCUA, 118 S. Ct. at 935 & n.6; in other
words, the plaintiff may show an inevitable congruence be-
tween the two interests. The two standards are thus very
similar.

It seems clear under NCUA that Upjohn has prudential
standing. Here, Upjohn is seeking to enforce (its interpreta-
tion of) section 355(j)(5)(B)(iv), a statute by which Congress
sought to regulate the timing of generic drug manufacturers'
entry into the market. Although the statute speaks directly
only to freeing the first generic drug company to file a

paragraph IV ANDA from competition from other generic
drug manufacturers, this necessarily entails freeing the pio-
neer drug producer from such competition as well. Thus,
Upjohn's interest in limiting competition for its product is,
"by its very nature," NCUA, 118 S. Ct. at 935 n.6, linked with
the statute's goal of limiting competition between generic
manufacturers. See also MD Pharmaceutical, Inc. v. Drug
Enforcement Admin., 133 F.3d 8, 12-13 (D.C. Cir. 1998)
(finding that a drug company was within the zone of interests
of an "entry-restricting" statute that regulated entry into its
market); Scheduled Aircraft, 87 F.3d at 1360-61 (finding that
a party seeking to enforce a "statutory demarcation" is a
suitable challenger) (quoting First Nat'l Bank & Trust, 988
F.2d at 1278).

Upjohn need not show anything more than that it has
standing to sue in order to demonstrate the existence of a
legally protected interest for purposes of Rule 24(a). See
Mausolf v. Babbitt, 85 F.3d 1295, 1299-1302 (8th Cir. 1996)
(finding that a showing of standing suffices to demonstrate a
legally protected interest for purposes of Rule 24(a)); but cf.
United States v. 39.96 Acres of Land, 754 F.2d 855, 859 (7th
Cir. 1985) (finding, on the peculiar facts of that case, that
more than a showing of standing was required). We there-
fore reject the district court's contrary conclusion that Up-
john did not have a sufficient interest in the action to inter-
vene.

The district court never reached the remaining elements of
the Rule 24(a) analysis--timeliness, the risk that Upjohn's
interests would be impaired, and whether Upjohn's interests
were already adequately represented in the litigation. Up-
john has included in its brief on this appeal a number of
arguments for the affirmance of the district court's injunction.
In order to determine whether Upjohn is properly a party to
the appeal of the injunction question, we must reach the
remaining Rule 24(a) issues. See Dimond v. District of
Columbia, 792 F.2d 179, 193 (D.C. Cir. 1986) (similarly ad-
dressing Rule 24(a) issues that the district court had, after
making an erroneous legal ruling, failed to reach); see also

Mausolf v. Babbitt, 125 F.3d 661, 666-67 (8th Cir. 1997)
(holding that if the court of appeals reverses the district
court's denial of a party's motion to intervene, that party may
participate in an appeal of a later ruling in the same litigation,
if it has met the procedural requirements for doing so). As
to timeliness, Upjohn sought to intervene a few weeks after
Mova initiated its action, and before the district court ruled
on the preliminary injunction; this cannot be regarded as
untimely. Upjohn's interests were also at risk; Upjohn was
in danger of losing market share to Mylan if the district court
denied the injunction and allowed Mylan's product on the
market. Finally, as to adequacy of representation, Mova is a
generic drug manufacturer, and therefore might have strate-
gic reasons not to press certain arguments available to Up-
john in anticipation of (perhaps) finding itself in Mylan's
situation in a future case. We thus conclude that Upjohn was
entitled to intervene as of right, and that Upjohn is therefore
a proper party to the appeal of the injunction order and in all
further proceedings in the district court.19

III. Conclusion

We find that the FDA exceeded its statutory authority in
imposing the successful-defense requirement as a prerequisite
to the invocation of the 180-day exclusivity rule by a first
applicant under section 355(j)(5)(B)(iv). The successful-
defense requirement is inconsistent with the statutory text
and structure, and is not justified by a need to protect the
essential function of the statute or a clear congressional
intent. We therefore affirm the district court's decision to
strike down the successful-defense requirement.

As to Upjohn's motion to intervene, we conclude that the
district court erred in finding that Upjohn's motion was moot
and that Upjohn did not have a sufficient interest in the

__________
19 Upjohn also challenges the district court's denial of its motion
for permissive intervention under Federal Rule of Civil Procedure
24(b). Because we find that Upjohn was entitled to intervene as of
right, we do not reach this issue.

subject-matter of the litigation. We also find that the other
elements of Rule 24(a) have been met by Upjohn, and reverse
the district court's denial of Upjohn's motion. Upjohn is
properly a party to this appeal, and to any proceedings on
remand.

So ordered.