Warner-Lambert Co. v. Shalala, 99-5048

• Decision Date: 11 February 2000
• Docket Number: No. 99-5048,99-5048
• Citation: 202 F.3d 326
• Parties: (D.C. Cir. 2000) Warner-Lambert Company, Appellant v. Donna E. Shalala, Secretary of Healthand Human Services, et al.,Appellees
• Court: U.S. Court of Appeals — District of Columbia Circuit

Page 326

202 F.3d 326 (D.C. Cir. 2000)

Warner-Lambert Company, Appellant v. Donna E. Shalala, Secretary of Healthand Human Services, et al.,Appellees

No. 99-5048

United States Court of Appeals FOR THE DISTRICT OF COLUMBIA CIRCUIT

Argued September 17, 1999

Decided February 11, 2000

Appeal from the United States District Court for the District of Columbia(No. 99cv00093)

Bruce N. Kuhlik argued the cause for appellant. With him on the briefs were Herbert Dym, Michael S. Labson, and Michael A. Listgarten.

Jeffrey B. Chasnow, Attorney, U.S. Department of Justice, argued the cause for appellees Donna E. Shalala, et al. With him on the brief was David W. Ogden, Acting Assistant Attorney General.

E. Anthony Figg argued the cause for appellee Mylan Pharmaceuticals, Inc. With him on the brief was Bart G. Newland. Steven M. Lieberman entered an appearance.

Before: Williams, Rogers and Garland, Circuit Judges.^*

Opinion for the Court filed by Circuit Judge Williams.

Williams, Circuit Judge:

When is a pill a capsule rather than a tablet? Plaintiff Warner-Lambert's entitlement to relief against the Food and Drug Administration turns on this point. Warner-Lambert believes that an anti-epilepsy drug made by Mylan Pharmaceuticals--having the interior form of a tablet but placed inside a capsule--cannot properly be viewed as a capsule. The Mylan product therefore has, according to Warner-Lambert, a different "dosage form" from that of Warner-Lambert's anti-epilepsy drug "Dilantin."¹ If Warner-Lambert is right, then the FDA should not have found the Mylan product "therapeutically equivalent" to Dilantin and (without putting Mylan's product through additional hoops) should not have approved Mylan's "abbreviated new drug application." And, again if Warner-Lambert is right, it would likely be entitled to the district court injunction that it sought, forcing the FDA to withdraw its finding of equivalence and to rescind its approval of the Mylan product. Because Warner-Lambert has not convinced us of any legal error in the FDA's decision on the capsule-tablet issue, we affirm the denial of the preliminary injunction.

* * *

The FDA must find a new drug to be safe and effective for its intended use before any person may introduce it into interstate commerce. See 21 U.S.C. § 355(a) (1994). The first, or "pioneer," applicant for a given drug must submit a new drug application ("NDA"), which includes "full reports of investigations which have been made to show whether or not such drug is safe for use and whether such drug is effective in use." Id. § 355(b). Once the FDA approves the application for the pioneer drug, it becomes a "listed drug," id. § 355(j)(7), and generic copies may be approved using the far simpler, abbreviated new drug application ("ANDA"), id. § 355(j)(2)(A)(ii)-(iv).

An ANDA will be approved if the applicant demonstrates that the generic drug is bioequivalent to the listed drug and has the same active ingredients, route of administration, strength, and dosage form. See id. § 355(j)(2)(A)(ii)-(iv), (j)(4); see also 21 CFR § 314.92(a)(1) (1999) (indicating the categories of drug products for which ANDAs may be filed).If the drug is different in any of these four respects, a generic manufacturer may use an abbreviated application only if it first files a "suitability petition" and the FDA grants it permission to file an ANDA. 21 U.S.C. § 355(j)(2)(C); 21 CFR § 314.93. The petition must be granted unless the FDA finds that the difference calls the safety and effectiveness of the drug into doubt. See 21 U.S.C. § 355(j)(2)(C). But drugs that require a suitability petition cannot be considered "therapeutically equivalent"² to the pioneer drug, and therefore cannot take advantage of state pharmacy laws that deem such products substitutable. See Serono Labs. v. Shalala, 158 F.3d 1313, 1317 (D.C. Cir. 1998). Substitutability is competitively important. When a doctor prescribes a drug by brand name, the pharmacist may (and in some states must) dispense a therapeutically equivalent generic alternative unless the doctor requires that the prescription be dispensed as written. See, e.g., N.Y. Educ. Law § 6816-a (McKinney 1999) (requiring generic drug substitution unless the doctor indicates otherwise).

Mylan Pharmaceuticals, Inc. filed an ANDA for its 100 milligram phenytoin sodium product, which it said satisfied the criteria for approval as a generic version of Dilantin. The FDA issued an approval letter on December 28, 1998, finding the product therapeutically equivalent to Dilantin. In so holding, it necessarily found that Mylan's product had the same dosage form as Dilantin, i.e., was in the form of a capsule.

Because the ANDA process is not public, the approval letter was Warner-Lambert's first notice of Mylan's application. But Warner-Lambert rose quickly to the challenge. Two weeks later it filed a complaint and request for preliminary injunction in the district court. All its claims rested on the argument that Mylan's product is properly classified as a tablet rather than a capsule. More specifically, however, Warner-Lambert argued that the FDA violated the statute by failing to apply the definitions of the United States Pharmacopoeia ("USP") for particular dosage forms as required by the Food, Drug and Cosmetic Act (under which, Warner Lambert urges, Mylan's product would be a tablet), and acted arbitrarily and capriciously by classifying Mylan's product as a capsule when it has previously classified indistinguishable products as tablets.

The district court disagreed and denied Warner-Lambert's preliminary injunction request on January 29, 1999, in a ruling from the bench. Warner-Lambert filed a timely notice of appeal.

* * *

It is commonly said that we review a district court's decision to deny a preliminary injunction under the deferential "clear error" or "abuse of discretion" standards, due to the "latitude the district court properly enjoys in balancing the four factors that traditionally constitute the preliminary injunction calculus." City of Las Vegas v. Lujan, 891 F.2d 927, 931-32 (D.C. Cir. 1989). And of course we always accord deference to the district court's findings of fact. See id. at 931. Here, however, the case can be resolved by reference to purely legal claims about the FDA's decision, legal claims that require deference not to the district court but to the agency. See Novicki v. Cook, 946 F.2d 938, 941 (D.C. Cir. 1991).

Warner-Lambert's statutory claim is that the dosage form definitions in the USP are binding upon the FDA under the Food, Drug and Cosmetic Act and that under the USP's definition, Mylan's product is a tablet. We assume in Warner-Lambert's favor that the USP definitions in question are indeed binding on the FDA, but we do not see that the FDA ruling here violates the key definition--that of capsules. The USP defines them as "solid dosage forms in which the drug is enclosed within either a hard or soft soluble container or 'shell.' " United States Pharmacopeia 1942 (1995). Warner Lambert identifies no characteristic of the Mylan product that is inconsistent with this definition on its face. Rather it relies on the declarations of two eminently distinguished members of the USP's Committee on Revisions, in which both argue that when read properly the USP definition precludes such a finding. But as Warner-Lambert conceded at oral argument, we owe these experts' interpretation no deference. See Tr. of Oral Argument at 16. Of course the absence of an administrative record explaining how the FDA applied the terms "dosage form," "capsule," or "tablet" in this case also deprives it of the deference that would ordinarily be due such reasoning. See City of Kansas City v. HUD, 923 F.2d 188, 192 (D.C. Cir. 1991). But where the agency ruling seems entirely congruent with the (allegedly) binding legal language, the existence of a conflicting interpretation by others, no matter how distinguished or well-informed about the background of the language, is an inadequate basis to overturn the agency's ruling. Of course the opinions of Warner-Lambert's experts would bolster Warner-Lambert's position if it had a convincing claim that inconsistencies with earlier FDA determinations rendered the FDA's decision arbitrary and capricious under the Administrative Procedure Act, 5 U.S.C. § 706(2)(A). But, as we shall see, that is not the case.

The core of Warner-Lambert's inconsistency claim is that the FDA has irrationally distinguished between virtually identical products, "classifying Mylan's capsule-shaped tablet in a gelatin shell as a 'capsule' while classifying gelatin-coated capsule-shaped tablets as 'tablets.' " Appellant's Initial Br. at 19. Warner-Lambert does not claim that the FDA has ever treated a capsule-shaped tablet in a gelatin shell as a tablet. That is, it makes no claim of direct self-contradiction.

ANDA applications are not treated as adversary proceedings, and evidently no one in the process formally posed Warner-Lambert's question as to why these superficially rather similar things should be differently classified. As a result the Mylan application file contains no explicit answer to the question. In the preliminary injunction proceeding, however, the FDA offered materials as to prior decisions...