UNITED STATES COURT OF APPEALS FOR THE D.C. CIRCUIT


WARNER LAMBERT CO

v.

SHALALA, DONNA E.


99-5048a

D.C. Cir. 2000


*	*	*


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
"Dilan- tin."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 addi- tional 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 injunc- tion 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 




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n * Circuit Judge Garland was originally a member of the panel but  did
not participate in the opinion in this case.


1. Dilantin is the brand name of a family of anti-epilepsy drugs 
manufactured by Warner-Lambert's Parke-Davis division. The  drug at
issue here is the largest-selling of the Dilantin line, the 100  mg
strength of extended phenytoin sodium capsules marketed as  Dilantin
Kapseals. For simplicity, we adopt Warner-Lambert's  terminology and
refer to the Dilantin Kapseals product simply as  "Dilantin."


* * *


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. s 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. s 355(b). Once the FDA approves the application  for the
pioneer drug, it becomes a "listed drug," id.  s 355(j)(7), and
generic copies may be approved using the far  simpler, abbreviated new
drug application ("ANDA"), id.  s 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. s 355(j)(2)(A)(ii)-(iv),  (j)(4); see also 21 CFR s
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. s 355(j)(2)(C);
21  CFR s 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. s 355(j)(2)(C). But  drugs that require a
suitability petition cannot be considered  "therapeutically
equivalent"2 to the pioneer drug, and there- fore 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




__________

n 2. Therapeutic equivalence turns on "pharmaceutical equiva- lence"
which is based in part upon identity of dosage form. Phar- maceutical
equivalence is defined in FDA regulations, see 21 CFR  s 320.1(c), and
an FDA publication known as the Orange Book,  available on the FDA's
web site, see .


dispense a therapeutically equivalent generic alternative un- less the
doctor requires that the prescription be dispensed as  written. See,
e.g., N.Y. Educ. Law s 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 applica- tion. But
Warner-Lambert rose quickly to the challenge.  Two weeks later it
filed a complaint and request for prelimi- nary 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 Phar- macopoeia ("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


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 deferen- tial "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 War- ner-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 back- ground 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


minations rendered the FDA's decision arbitrary and capri- cious under
the Administrative Procedure Act, 5 U.S.C.  s 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 proceed- ings, 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, how- ever, the FDA offered materials as to
prior decisions that  shed some light on the subject. For example, an
FDA  response to a citizen petition filed on behalf of Novartis 
Pharmaceuticals stated its position that "dosage form is the  way of
identifying the drug in its physical form, which is  linked both to
physical appearance of the drug product and to  the way it is
administered." FDA Docket No. 96P-0459,  Nov. 2, 1998, Response to
Petition filed by Novartis, Inc., at  12 (Nov. 2, 1998), Joint
Appendix ("J.A.") 102, 113 (quoting  FDA Docket No. 93P-0421, Aug. 12,
1997, Response to  Petition filed by Pfizer, Inc., at 4). Similarly
FDA responded  to such a petition by Zenith Goldline Pharmaceuticals,
Inc.:  "The contents of a capsule do not change the fact that the 
product is a capsule.... Compressed tablets with a gelatin  coating
are considered by the Agency to be tablets." FDA  Docket No. OGD
98-045, Mar. 31, 1998, Response to Petition  filed by Zenith Goldline


These opinions support two inferences. First, they state  the general
criteria that FDA says are properly applied in  making the "dosage
form" determination--namely, that it is a 


matter of looking to a drug's (1) physical appearance and (2)  the way
it is administered. Second, those general criteria are  consistent
with the FDA's conduct here: Both products (Di- lantin and the Mylan
product) are administered orally,3 and  their physical appearance--a
capsule shell with some con- tents--is the same. Warner-Lambert has
not undertaken to  show that the Mylan product looks "more" like a
gelatin- coated tablet than it looks like what it is, a capsule with a
 tablet inside.


Warner-Lambert argues that these rulings were not part  of the
administrative record. True enough--but that hardly  renders them
immaterial as evidence that the FDA has  formulated a principle and
that its individual case decisions  have stuck to it. Indeed, at that
level Warner-Lambert  really has no complaint.


Its real complaint, then, is that the line the FDA has drawn  is rather
formalistic; so much so as to be in effect arbitrary  and capricious.
Obviously drawing distinctions without a  difference may be arbitrary.
See Independent Petroleum  Ass'n of Am. v. Babbitt, 92 F.3d 1248,
1258-60 (D.C. Cir.  1996); Green Country Mobilephone, Inc. v. FCC, 765
F.2d  235, 238 (D.C. Cir. 1985). But consider Warner-Lambert's  basic
position. It rests on the statutory requirement that an  ANDA can be
approved only if the new drug is identical in  "dosage form." Its
attack on the FDA's line-drawing can be  framed in three ways: It may
be saying that any line between  capsules and tablets is silly or
pointless, in which case the two  dosage forms should be collapsed. If
so, Warner-Lambert  cannot have been harmed here, as the dosage form
would  plainly have been identical for both products under the




__________

n 3. The scope of the "administration" part of the dosage form 
definition remains unclear. FDA acknowledges that "method of 
administration" is more subtle than simply distinguishing between  the
manner in which the drug is introduced into the patient, such as 
orally, topically, or via injection. But we have no occasion to probe 
the contours of "method of administration" in this case because  there
is no allegation that Dilantin and Mylan's product have  different
methods of administration.


native rule. Or Warner-Lambert may be saying that while  there should
be a line between capsules and tablets, the  FDA's line is incapable
of consistent application because  there is no method for separating a
gelatin coating from a  capsule shell. But Warner-Lambert has provided
no reason  to believe that the FDA is unable to distinguish
consistently  between the two. Finally, Warner-Lambert may be saying 
the FDA has drawn the line in the wrong place, that capsules 
containing tablets belong with tablets rather than with cap- sules.
Yet it offers virtually no reason to think that there is  anything
irrational about the FDA's choice of exactly where  in these
shadowlands it should locate this border (a necessary  border, under


The exception (the reason the previous sentence says "vir- tually no
reason") is a claim tucked away in the section of  Warner-Lambert's
brief devoted to USP definitions. It as- serts that the way in which
the body absorbs a garden-variety  capsule is different from the way
it absorbs a tablet in a  capsule, so that the FDA's capsule
classification of the Mylan  product may lead to inaccurate inferences
about its absorp- tion.


There are at least three difficulties with this claim. First, 
Warner-Lambert made no attack on the FDA's bioequiva- lence finding.
Bioequivalence requires an FDA finding that  "the rate and extent of
absorption of the [new] drug do not  show a significant difference
from the rate and extent of  absorption of the listed drug." 21 U.S.C.
s 355(j)(8)(B).  Thus, contrary to what Warner-Lambert proposes here,
we  must assume that rate and extent of absorption are the same. 
Second, Warner-Lambert's argument would place limits on  the capsule
dosage form that have no statutory or regulatory  basis. As
Warner-Lambert acknowledges, Reply Br. at 9,  multiple tablets
encapsulated in a shell are treated as cap- sules. Warner-Lambert
evidently accepts this as sound  practice. But under Warner-Lambert's
conception of dosage  form, a liquid-filled capsule (which
Warner-Lambert agrees is  properly deemed a capsule) that sought to
gain approval as a  generic equivalent of this tablet-filled capsule
would have the  added hurdle of showing that the liquid would perform


same way as the tablets independent of a showing of bioequi- valence.
The FDA has not required such a showing. Third,  contrary to
Warner-Lambert's assertion that bioequivalence  is insufficient
because Mylan's product may have dangerous  lot-to-lot variation, the
record contains graphs and other  materials purporting to demonstrate
that Mylan's product is  at least as consistent as Dilantin, see J.A.
245-46 (depicting  lot-to-lot dissolution profiles for both products),
and Warner- Lambert makes no claim that the natural reading of these 
graphs--namely that the profiles are identical--is in error.


Given the consistency of the FDA's classification of the  Mylan product
with the language of the USP, with its stated  criteria for making
dosage form classifications, and with its  specific dosage form
classifications, there were no grounds for  granting the requested
injunction. The decision of the dis- trict court is


Affirmed.