Opinion ID: 184499
Heading Depth: 3
Heading Rank: 1

Heading: Applicable Principles of Judicial Review

Text: In assessing the validity of an agency's interpretation of astatute, we begin by asking whether Congress has directlyspoken to the precise question at issue; if so, the court, aswell as the agency, must give effect to the unambiguouslyexpressed intent of Congress. Chevron U.S.A. Inc. v. Natural Resources Defense Council, Inc., 467 U.S. 837, 842-43(1984). If we find that the statute is silent or ambiguouswith respect to the specific issue, the question for the court iswhether the agency's answer is based on a permissible construction of the statute. Id. at 843. In the district court's judgment, the FDA's pragmaticreading of the statute could not survive the first prong ofChevron. Concluding that the language of the statute maybe complex, and even cumbersome, but it is plain and unambiguous, and that the statute does not include a 'successfuldefense' requirement, and indeed it does not even require theinstitution of patent litigation, the district court found that,under the plain language of the statute, if a paragraph IVANDA has been filed by a prior applicant, the FDA mustdelay approval of all subsequent ANDAs until either thecourt-decision trigger or the commercial-marketing trigger issatisfied. We think that the district court achieved the right result,but we are not quite as sanguine as the district court that, inapplying the first prong of Chevron, it suffices to look only atthe plain language of the statute. [I]n expounding a statute,we must not be guided by a single sentence or member of asentence, but look to the provisions of the whole law, and toits object and policy. Pilot Life Insurance Co. v. Dedeaux,481 U.S. 41, 51 (1987); see also McCarthy v. Bronson, 500U.S. 136, 139 (1991). Here, the FDA cannot point to anyparticular ambiguity in the words of section 355(j)(5)(B)(iv) that permits it to interpolate its successful defense requirement. Instead, the FDA's argument is that a literal readingof the statute would thwart Congress's central goal, in enacting the Hatch-Waxman Amendments, to bring generic drugsonto the market as rapidly as possible. In effect, the FDA seeks to invoke the long-standing rulethat a statute should not be construed to produce an absurdresult. It is a familiar rule, that a thing may be within theletter of the statute and yet not within the statute, becausenot 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., 513U.S. 64, 68-69 (1994) (rejecting the most natural grammatical 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 andthe Limits of Literalism, 44 Am. U.L. Rev. 127 (1994). Over ahundred 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 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, 74 U.S. (7 Wall.) 482, 487 (1868)(citations omitted). In deciding whether a result is absurd, we consider notonly whether that result is contrary to common sense, butalso whether it is inconsistent with the clear intentions of the statute's drafters--that is, whether the result is absurd whenconsidered in the particular statutory context. If  'the literalapplication of a statute will produce a result demonstrably atodds with the intentions of its drafters,' ... the intention ofthe drafters, rather than the strict language, controls. United 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 absurdresults allows an agency to establish that seemingly clearstatutory language does not reflect the unambiguously expressed intent of Congress, Chevron, 467 U.S. at 842, andthus to overcome the first step of the Chevron analysis. Butthe agency does not thereby obtain a license to rewrite thestatute. When the agency concludes that a literal reading ofa statute would thwart the purposes of Congress, it maydeviate no further from the statute than is needed to protectcongressional intent. Of course, the agency might be able toshow that there are multiple ways of avoiding a statutoryanomaly, all equally consistent with the intentions of thestatute's drafters (and equally inconsistent with the statute'stext). In such a case, we would move to the second stage ofthe Chevron analysis, and ask whether the agency's choicebetween these options was based on a permissible construction of the statute. Id. at 843. Otherwise, however, ourreview of the agency's deviation from the statutory text willoccur under the first step of the Chevron analysis, in whichwe do not defer to the agency's interpretation of the statute. Here, we think that the FDA's interpretation cannot survive analysis under the first step of Chevron. The FDA'ssuccessful defense requirement achieves the FDA's statedgoal of preventing first applicants who are not sued or wholose their suits from benefiting from the exclusivity period. But it also does more. The FDA had two routes by which itcould have addressed the problem of first applicants who losetheir suits, which we will call the wait-and-see approach andthe 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 firstapplicant lost, the exclusivity period would not apply; if hewon, it would.7 The FDA chose the other option, the winfirst approach. Under this approach, later applicants do notneed to wait to see whether the first applicant wins or loses. Instead, while the first applicant's litigation is underway, theFDA may approve the applications of later ANDA applicantseffective immediately, if they are otherwise eligible for approval.8 Thus, the first applicant must win its lawsuit beforesection 355(j)(5)(B)(iv) has any effect on subsequent applicants at all. It is the FDA's decision to adopt the win-first approachthat led to the present litigation. If the FDA had insteadchosen the wait-and-see approach, the FDA could not haveapproved Mylan's application when it did; instead, Mylanwould have needed to wait for the end of Mova's patentinfringement suit. We will therefore focus on this aspect ofthe successful-defense requirement. We conclude that the FDA's successful-defense requirement is inconsistent with the unambiguously expressed intentof Congress. The rule is gravely inconsistent with the textand structure of the statute. Nor can the FDA show that thesuccessful-defense requirement is needed to avoid a resultdemonstrably at odds with the intentions of [section355(j)(5)(B)(iv)'s] drafters. Ron Pair Enterprises, 489 U.S.at 242. The FDA could have adopted a more narrow solutionto the problem of first applicants who are never sued or wholose their suits. It instead adopted the broad win-first rule,which it cannot show is needed to implement congressionalintent. In effect, the FDA has embarked upon an adventurous transplant operation in response to blemishes in the __________ 7 We do not mean to foreclose a third possibility, which is thatsome lawsuit other than that against the first applicant mightsatisfy the court-decision trigger before the first applicant's suit isover. We discuss this possibility below. 8 That is, if they have not been sued by the patent-holder, and aretherefore not subject to the 30-month waiting period, or if the 30month period has expired. statute that could have been alleviated with more modestcorrective surgery.