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 Pharmaceutical 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. § 355(j)(5)(B)(iv) (1994),
1
to compel the FDA to delay 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 approval of successive generic drug applications is quite complex, 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 statutory provision, 21 U.S.C. § 355(j)(5)(B)(iv), granted a 180-day market
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. 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.,
In 1984, Congress enacted the HatchWaxman Amendments, 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, subsequent 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 infringe that patent, and, if not, why not. The statute provides ANDA applicants with four certification options: they may certify (T.) 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. § 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. § 355(j)(5)(B)(i). If
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 vindicate its patent in court before the generic competitor is allowed entry into the market. 21 U.S.C. § 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. § 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:
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 certification, 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. § 355(j)(5)(B)(iv). This provision on its face appears 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
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 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 certification 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 application has successfully defended against a suit for patent infringement brought within days of the patent owner’s receipt of notice submitted under § SlJp.95, approval of the subsequent abbreviated new drug application 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 application 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. § 314.107(c)(1) (emphasis added).
B. The Factual Scenario of This Case
Glyburide is a drug used in treating diabetes, and mieronized glyburide is one form of that drug. Upjohn holds a patent for a particular formulation of mieronized glyburide entitled “Spray-Dried Lactose Formulation of Mieronized Glyburide.”
In December, 1994, Mova filed an ANDA for a generic form of mieronized 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 mieronized glyburide. Mylan’s initial filing contained a paragraph III certification; this meant that Mylan conceded patent infringement, 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. § 314.107(e)(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 Mylan’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 effec
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, however, 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 subsequent 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.”
CityFed, Financial Corp. v. Office of Thrift Supervision,
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.
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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 appropriate 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 applicants 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 trigger 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. § 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. Natural Resources Defense Council, Inc.,
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 unambiguous,” 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 poli
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,
The common sense of man approves the judgment mentioned by Puffendorf, that the Bolognian law which enacted “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,
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.”
United States v. Ron Pair Enterprises,
The rule that statutes aré to be read to avoid absurd results allows an agency to establish that seemingly clear statutory language does not reflect the “unambiguously expressed intent of Congress,”
Chevron,
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 requirement 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,
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 Pharmaceuticals, 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 commercial-marketing trigger seems intend
If the first applicant eventually wins its lawsuit, the exclusivity period is counted as though it had begun to run when the applicant started commercial marketing. Thus, an applicant who begins commercial marketing 120 days before winning 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 trigger 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 supposed 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 commercial 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 approval 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 minimizing 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 earlier.” 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 successful-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 enacting 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 statutory text.
We begin by setting aside the problems of the first applicant who is never sued or who loses his lawsuit. The FDA may or may not
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 paragraph 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 not have the effect of rendering the exclusivity period inapplicable after such an amendment, and of course we owe deference to the agency on the interpretation of its own regulations. 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 approaches; 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 statutory 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,
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
In such a situation, a literal reading of the statute admittedly 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—á result seemingly at odds with Congress’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 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 concluded 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 litigation, the first applicant’s patent-infringement suit could easily take longer than thirty months. The successful-defense requirement 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 possibility. 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 limited to infringement suits by
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. § 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 prevails, 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 (relatively) 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 mousetrap.
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. § 355(j)(5)(B)(iv). 16 It seems odd to reward the first applicant if some later applicant was the party that actually prevailed in the patent-infringement litigation. 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,
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 § 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 the action may as a practical matter impair or impede the applicant’s ability to protect that interest,”
id.;
and (4) whether “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,
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 evidence or new arguments in future proceedings, had Upjohn (or some other party) wished to present them. And intervening 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 And-over,
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,
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
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,
The test applied by
NCUA
is not far removed from this circuit’s “suitable challenger” test.
See, e.g., Scheduled Airlines,
It seems clear under
NCUA
that Upjohn has prudential standing. Here, Upjohn is seeking to enforce (its interpretation 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 pioneer drug
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 Mausolfv. Babbitt,
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. Upjohn 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,
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 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.
So ordered.
Notes
. At the time that Mova brought its action, this section was designated 21 U.S.C. § 355(j)(4)(B)(iv). On November 21, 1997, the 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.
.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 engaging 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 cooperate 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.
. This should probably read “containing.”
. 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.
. 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.
. The FDA notes that "the mere existence of competition is not irreparable harm, in the absence of substantiation of severe economic impact.”
WMATC v. Holiday Tours,
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
. 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.
. 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.
.We note that the Fourth Circuit recently came to the same conclusion in an unpublished opinion.
See Granutec, Inc. v. Shalala,
Nos. 97-1873, 97-1874, slip op. at 13-14,
. 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 exclusivity 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 § 314.107(c) accordingly.” Abbreviated New Drug Application Regulations, 59 Fed.Reg. 50,338, 50,353 (1994).
. 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.
. The relevant regulation provides;
An applicant who has submitted a certification under paragraph (a)(12)(i)(A)(4) of this section and is sued for patent infringement within 45 days of the receipt of notice sent under § 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 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. § 314.94(a)(12)(viii)(A).
.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 “substantial deference” to an interpretation by the FDA of its own regulations, which has "controlling weight unless it is plainly erroneous or inconsistent with the regulation.”
S.G. Loewendick & Sons, Inc. v. Reich,
. 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 circumstances, neither party would seem to have maximum incentive to bring the litigation to a close.
. 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 AND As that are "subsequent” to a successful defense by the first applicant, 21 C.F.R. § 314.107(c)(1), and an ANDA that has already been approved does not fall in this category.
. This is the most natural reading of the statute, but we do not necessarily find that it is the only permissible reading.
. Indeed, the first applicant may still be enmeshed in patent-infringement litigation when the 180-day period begins, and therefore be unable to take advantage of the exclusivity period.
. 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 purposes of the statutory scheme. Certainly, there would be no danger 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.,
. 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.