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


TEVA PHARMACEUTICALS

v.

FDA


99-5022a

D.C. Cir. 1999


*	*	*


Rogers, Circuit Judge: Teva Pharmaceuticals and Purepac  Pharmaceutical
Company appeal the denial of injunctive relief  requiring the Food and
Drug Administration ("FDA") to  recognize the dismissal of a
declaratory judgment complaint  for patent infringement as a "court
decision" under the  Abbreviated New Drug Application ("ANDA")
statute. See  21 U.S.C. s 355(j)(5)(B)(iv)(II) (Supp. III 1997).
Appellants  are "subsequent" ANDA applicants hoping to market ticlopi-
dine tablets, a generic version of the name-brand drug "Ti- clid,"
used to treat stroke victims.1 To meet the require-




__________

n 1 Purepac has joined in the argument presented in the brief  filed by
Teva, having been unsuccessful in a previous challenge to  the FDA's
interpretation of the ANDA statute in Purepac Pharma- ceutical Co. v.
Friedman, 162 F.3d 1201 (D.C. Cir. 1998). Purepac  now seeks reversal
of the district court's denial of injunctive relief  and a remand for
entry of an order directing the FDA to make all  approved ANDAs for
generic ticlopidine products, including Pure- pac's, effective as of
February 10, 1999. Teva seeks a similar 


ments of the ANDA statute, Teva sued the patent holder2 in  the Central
District of California in order to obtain a "court  decision" that
would start, or trigger, a 180-day period of  market exclusivity for
the first ANDA applicant, and thereaf- ter allow appellants to market
their generic drug. The  California court dismissed the complaint for
lack of subject- matter jurisdiction after finding, based on the
patent holder's  admission of non-infringement, that Teva lacked a
reasonable  apprehension of suit by the patent holder. The FDA never-
theless refused to recognize the dismissal as a triggering  "court
decision" under the ANDA statute. Because we con- clude that the FDA's
refusal was arbitrary and capricious  inasmuch as the FDA has taken an
inconsistent position in  another case and failed to explain
adequately the inconsisten- cy, we reverse and remand the case to the
district court to  determine anew whether injunctive relief is


I.


The statutory background is succinctly summarized as fol- lows. In
1984, Congress amended the Food and Drug Act in  order to expedite the
approval of generic versions of name- brand drugs that already have
FDA approval, thus making  available more low-cost generic drugs. See
Drug Price Com- petition & Patent Term Restoration Act of 1984, Pub.
L. No.  98-417, tit. I, 98 Stat. 1585 (1984) (codified as amended at
21  U.S.C. s 355 (1994 & Supp. III 1997)); see also H.R. Rep.  No.
98-857, pt. 1, at 14 (1984), reprinted in 1984 U.S.C.C.A.N. 




__________

n remedy: reversal and remand, with the district court ordering the 
FDA to make Teva's ANDA effective as of February 10th.


2 Syntex (U.S.A.), Inc., the holder of Patent No. 4,591,592  (" '592
patent" or "patent") that covers a finished dosage formula- tion of a
ticlopidine tablet, but not the active pharmaceutical ingre- dient
ticlopidine hydrochloride, and Hoffmann-LaRoche Laborato- ries Inc.,
which markets ticlopidine tablets under the brand-name  "Ticlid," are
two of the intervenors. For ease of reference we refer  to Syntex and
Hoffmann-LaRoche collectively as "Syntex." Also  intervening is
TorPharm, which has identified itself as the first  applicant to file


2647, 2647. Under the so-called Hatch-Waxman amend- ments, an
abbreviated new drug application process allows  applicants, upon
meeting certain requirements, to proceed  more quickly to the
marketplace. The ANDA applicant must  show that: (i) the use of the
drug has been previously  approved; (ii) the new drug contains the
same active ingredi- ent(s) as the previously approved drug, or
document the  differences; (iii) the new drug has the same route of
adminis- tration, dosage form, and strength of the previously approved
 drug, or document the differences; (iv) the new drug is the 
bioequivalent or has the same therapeutic effect as the previ- ously
approved drug; (v) the new drug has the same labeling  as the
previously approved drug, or the differences are  approved; and (vi)
it has complied with other statutory  requirements, which include
providing a full list of articles  used as components, a full
statement of composition, samples  of the drug, labeling specimens,
and a description of manufac- turing, processing, and packaging. See


To avoid the patent infringement problems inherent in such  a statutory
scheme, the ANDA applicant must provide the  FDA with a certificate
establishing that the marketing of the  generic drug will not infringe
the patent for the listed drug.  To this end, the applicant must
certify that: (I) the patent  information has not been filed, (II) the
patent has expired,  (III) the patent will expire on a specified date,
or (IV) the  "patent is invalid or will not be infringed by the
manufacture,  use, or sale of the new drug for which the application
is  submitted." Id. s 355(j)(2)(A)(vii). As part of a certification 
under Paragraph IV, the ANDA applicant must notify the  patent holder
and approved applicants of its application and  include a statement of
the factual and legal basis for the  applicant's opinion that the
patent is not valid or will not be  infringed. See id. s 355(j)(2)(B).
Under FDA regulations,  the applicant may also certify that the patent
is unenforcea- ble. See 21 C.F.R. s 314.94(a)(12)(i)(A)(4) (Westlaw


ANDA applicants who submit Paragraph IV certifications  are subject to
a "market-exclusivity provision," see 21 U.S.C. 


s 355(j)(5)(B)(iv), under which previous applicants are grant- ed 180
days during which subsequent applications cannot be  approved.3 This
period is started, or triggered, by the earlier  of (1) the date the
Secretary of Health and Human Services  receives notification from the
previous applicant of the first  commercial marketing of its drug or
(2) the date of a "deci- sion of a court" in a patent or declaratory
judgment action  "holding" that the patent is either "invalid or not
infringed."  Id.; see also id. s 355(j)(5)(B)(iii) (describing suits
for patent  infringement or declaratory judgment).


Heretofore, the court invalidated the FDA's "successful  defense"
requirement, whereby the first ANDA applicant  could obtain 180 days
of market exclusivity only after success- fully defending a patent
lawsuit. See Mova Pharm. Corp. v.  Shalala, 140 F.3d 1060, 1076 (D.C.
Cir. 1998). Accord  Granutec, Inc. v. Shalala, No. 97-1873, 1998 WL
153410, at  *7 (4th Cir. April 3, 1998). In response, the FDA issued a
 "Guidance for Industry" announcing its intention to promul- gate new
regulations on market exclusivity and "until such  time as the
rulemaking process is complete," to "regulate  directly from the
statute, and ... make decisions on 180-day  generic drug exclusivity
on a case-by-case basis." See Guid- ance for Industry: 180-Day Generic
Drug Exclusivity Under  the Hatch-Waxman Amendments to the Federal
Food, Drug  and Cosmetic Act 4 (June 1998) ("Guidance for Industry"). 
The court upheld this approach in Purepac Pharmaceutical  Co. v.
Friedman, 162 F.3d 1201, 1204-05 (D.C. Cir. 1998): the  FDA may
regulate directly from the statute and is not  required to maintain
any litigation requirement in determin- ing the first applicant's
entitlement to 180 days of market  exclusivity.




__________

n 3 As interpreted by the FDA, the statute does not guarantee  the
first ANDA applicant a 180-day period of exclusivity. The 
court-decision trigger can be activated by any subsequent ANDA 
applicant's litigation whether or not the first applicant has enjoyed 
a period of exclusivity. See Guidance for Industry: 180-Day Ge- neric
Drug Exclusivity Under the Hatch-Waxman Amendments to  the Federal
Food, Drug and Cosmetic Act 5 (June 1998).


II.


Teva challenges the denial of injunctive relief on the princi- pal
ground that the FDA's refusal to treat the dismissal of  Teva's
declaratory judgment action as a triggering "court  decision" is
inconsistent with the ANDA statute and hence,  the district court
erred in ruling that Teva had failed to  demonstrate a likelihood of
success on the merits. Basically,  Teva contends that the California
dismissal is functionally  equivalent to a final decision of
noninfringement and unen- forceability on the merits because it was
based on the patent  holder's express representation to Teva and the
California  court that Teva's formulation did not infringe the patent
and  that the patent holder would not sue Teva for infringement. 
Indeed, Teva goes so far as to maintain that its interpretation  of
the statute is the only possible alternative to the FDA's 
impermissible construction under the circumstances of this  case;
otherwise, subsequent ANDA applicants' efforts to use  the
Hatch-Waxman procedure could be thwarted anytime a  patent holder
stated that it did not intend to enforce its  patent, thus preventing
the courts from exercising subject  matter jurisdiction to issue the


According to Teva's complaint, on June 20, 1997, Teva filed  its ANDA
to market ticlopidine, a generic version of the drug  "Ticlid." While
it awaited tentative approval of its applica- tion, Teva sued Syntex,
seeking a declaratory judgment of  noninfringement of Syntex's patent
for a finished dosage  formulation of ticlopidine tablets.4 On the
same day, Syntex  sent Teva a letter expressing the opinion that Teva
would not  infringe Syntex's patent, declaring: "We will make no claim
 of patent infringement based on the sale of ticlopidine hydro-
chloride tablets having the formulation you have disclosed to  us."
Thereafter, Teva prepared a joint motion for entry of 




__________

n 4 Syntex had previously sued Teva and others for possible 
infringement of its process patent for ticlopidine, but voluntarily 
dismissed its complaint against Teva without prejudice once Teva 
revealed its process. That litigation was unrelated to the formula-
tion patent at issue in the declaratory judgment action.


consent judgment that would hold Syntex's patent not infring- ed; but
Syntex instead moved to dismiss the complaint for  lack of
subject-matter jurisdiction, explaining:


Given Syntex's express assurance that it would not bring  suit against
Teva on the '592 patent, Teva can have no  reasonable apprehension
that it will face a lawsuit for  infringement of the '592 patent.
Without such reason- able apprehension, no actual case or controversy
exists of  sufficient immediacy or reality to base jurisdiction over 
Teva's declaratory judgment claim.


Accompanying the motion was a declaration by John Parise,  counsel for
Syntex, referring to the June 8, 1998, letter that  Syntex sent Teva
stating that Syntex would make no claim of  patent infringement
against Teva. Noting that under Feder- al Rule Civil Procedure
12(b)(1) the district court could  consider materials outside of the
pleadings, see Dreier v.  United States, 106 F.3d 844, 847 (9th Cir.
1997), Syntex  attached a proposed order with three findings,
including that  Teva "lacked and lacks a reasonable apprehension of
suit by  Syntex for infringement of [the] ... [p]atent." The district 
court granted Syntex's motion, adopting its findings, specifi- cally
that Teva "lacks a reasonable apprehension of suit by  Syntex for
infringement of [the patent];" hence there was "no  justiciable case
or controversy between the parties concerning  any infringement by
Teva of the '592 [p]atent," and conse- quently the court lacked
subject matter jurisdiction over the  action.


On October 29, 1998, the FDA tentatively approved Teva's  ANDA to
market ticlopidine. However, the FDA informed  Teva that because there
was a previous ANDA applicant and  neither commercial marketing nor a
court decision had oc- curred, its application was ineligible for
final approval. Teva  attempted to persuade the FDA that the
California dismissal  satisfied the "court decision" requirement, but
the FDA did  not respond to Teva's request for an effective approval
date  and on December 2, 1998, notified Teva that it refused to  meet
to discuss the issue. Teva then filed the instant lawsuit  in district
court for a declaratory judgment that Teva is 


entitled to have its ANDA become effective on February 10,  1999 (180
days after the California dismissal), an injunction  making Teva's
ANDA effective on that date, and a temporary  restraining order to
forestall the FDA from approving the  first ANDA application if such
approval would give the first  applicant any exclusive marketing
beyond February 10, 1999.


The district court declined to award injunctive relief. It  concluded
for three reasons that Teva could not demonstrate  a likelihood of
success on the merits. First, the district court  ruled that the
California dismissal did not fall within the plain  language of s
355(j)(5)(B)(iv)(II), and, second, that even if  Teva could show that
the statute was ambiguous, it was  unlikely to succeed in showing that
the FDA's interpretation  was impermissible, or that Teva's
interpretation was the only  permissible alternative. The district
court concluded, third,  that Teva's reliance on patent law decisions
of the Federal  Circuit was misplaced because they had no direct
bearing on  the "court decision" provision in ANDA. Consequently, the 
district court reasoned, in view of language in decisions of this 
court,5 that the triggering "court decision" provision required 
nothing less than a decision on the merits. The district court  was
also unpersuaded by Teva's arguments concerning irrep- arable harm,
injury to the other parties, and the public  interest.6


III.


On appeal, Teva contends that the district court erred in  denying
injunctive relief because the California dismissal  qualified as a
"court decision" under s 355(j)(5)(B)(iv)(II) and  the FDA's refusal
to recognize the dismissal as such was  arbitrary and capricious, an
abuse of discretion, and based on  an unreasonable and impermissible
interpretation of the stat- ute. Our review of the denial of
injunctive relief is for abuse  of discretion, but we review de novo
the district court's 




__________

n 5 See Purepac, 162 F.3d at 1205 n.6; Mova, 140 F.3d at 1073 & 


6 See Mova, 140 F.3d at 1066 (outlining standard for prelimi- nary
injunctions).


conclusion of law, namely that Teva was unlikely to prevail in  its
challenge to the FDA's refusal to treat the California  dismissal as a
triggering "court decision." See Mova, 140  F.3d at 1066 (citing
CityFed Financial Corp. v. Office of  Thrift Supervision, 58 F.3d 738,
746 (D.C. Cir. 1995)).


The FDA maintains that its interpretation of the "court  decision"
provision is entitled to deference under Chevron  U.S.A., Inc. v.
Natural Resources Defense Counsel, Inc., 467  U.S. 837, 842-44 (1984).
In fact, however, the FDA has  offered no particular interpretation of
that provision, relying  instead on its authority to interpret the
provision narrowly  until it promulgates a new rule. Without regard to
how the  FDA should address the issue in its next rulemaking, it is 
clear that the FDA, consistent with its statement that it  would
"regulate directly from the statute" on a "case-by-case  basis," see
Guidance for Industry at 4; see also Purepac, 162  F.3d at 1205,
cannot avoid the merits of Teva's contention  that the California
dismissal satisfies the "court decision"  requirement under s
355(j)(5)(B)(iv)(II). We review the  FDA's response to Teva's claim
guided by settled principles  of administrative law. See 5 U.S.C. s
706 (1994); Southwest- ern Bell Tel. Co. v. FCC, 168 F.3d 1344, 1352
(D.C. Cir. 1999).  Upon a review of the record, we conclude that the
FDA's  response was arbitrary and capricious.


First, the FDA concedes that its refusal to recognize the  California
dismissal as a triggering "court decision" is not  compelled by the
statutory language. The statute requires a  "decision of a court
holding the patent ... invalid or not  infringed." See 21 U.S.C. s
355(j)(5)(B)(iv)(II). A "decision"  can take several forms, including
final judgment after a full  trial, summary judgment or partial
summary judgment, or  even a dismissal for failure to state a cause of
action. The  term "holding," most often contrasted with the term
"dicta,"  is also susceptible to interpretation. See, e.g., Seminole
Tribe  of Fla. v. Florida, 517 U.S. 44, 66-67 (1996); Wilder v. Apfel,
 153 F.3d 799, 803-04 (7th Cir. 1998); Gersman v. Group  Health Ass'n,
975 F.2d 886, 897 (D.C. Cir. 1992). Further- more, the significance of
a court's "decision" or "holding"  often lies in its preclusive
effect. Of course, as intervenors 


maintain, not every court action can be construed as a  "decision" with
a "holding"; for example, a dismissal for lack  of personal
jurisdiction is not a decision on the merits and has  no preclusive


But the California dismissal cannot be classified as a typical 
dismissal for lack of subject matter jurisdiction. Although, as  a
general rule, such a dismissal has no preclusive effect  because the
court lacked authority or competence to hear and  decide the case, see
Prakash v. American Univ., 727 F.2d  1174, 1182 (D.C. Cir. 1984)
(citing 5 C. Wright & A. Miller,  Federal Practice s 1350, at 554
(1969)),7 here the dismissal  was based exclusively and necessarily on
Syntex's declaration  that Teva's product would not infringe its
patent and its  express disavowal of an intent to sue. Syntex
expressly  sought to have the California court consider more than the 
pleadings, notwithstanding its request for dismissal for lack of 
subject matter jurisdiction, noting in its motion papers that  the
court could grant a motion to dismiss under Federal Rule  of Civil
Procedure 12(b)(1) based on materials in addition to  the pleadings
themselves. Before the California court was  Syntex's June 8th letter
stating that Teva's "formulation ...  does not infringe" the patent,
and the declaration of Syntex's  counsel that Teva's "formulation did
not warrant bringing a  patent infringement action." It also had
express findings of  fact proposed by Syntex, including the one
necessary for a  finding of no case or controversy, namely that Teva
lacked a  reasonable apprehension of suit by Syntex for infringement. 
Syntex not only remained silent after receiving Teva's notice  of its
ANDA filing and failed to file an infringement suit  within 45 days
after receiving Teva's Paragraph IV notifica- tion, but it also sought
to have Teva's complaint dismissed for  lack of subject matter
jurisdiction. It was able to file such a  motion, however, only
because of its own statements and  actions eliminating any case or
controversy about the enforce- ability of the patent against Teva. Its
motion was granted on  the basis of an express finding of fact by the




__________

n 7 See also 5A Charles Alan Wright & Arthur R. Miller,  Federal
Practice and Procedure s 1350, at 225 (2d ed. 1990).


regarding Teva's reasonable nonapprehension of suit, as Syn- tex itself
had proposed as part of its motion to dismiss.  From the perspective
of the California court, then, Syntex's  declaration and conduct
eliminated the need for a declaratory  judgment because Syntex would
be estopped from challeng- ing Teva's marketing of its generic drug on
the ground of  patent infringement.


The FDA and intervenor TorPharm (the first ANDA filer)  conceded at
oral argument that the California dismissal pre- vents Syntex from
suing Teva for infringement. The conclu- sion that the California
dismissal has estoppel effect is sup- ported by the decisions of the
United States Court of Appeals  for the Federal Circuit. That court
has recognized that a  dismissal of a declaratory judgment action for
lack of a case  or controversy due to the patent holder's disavowal of
any  intent to sue for infringement has preclusive effect. See  Super
Sack Mfg. Corp. v. Chase Packaging Corp., 57 F.3d  1054, 1059 (Fed.
Cir. 1995); Spectronics Corp. v. H.B. Fuller  Co., 940 F.2d 631,
636-38 (Fed. Cir. 1991); see also Fina  Research, S.A. v. Baroid Ltd.,
141 F.3d 1479, 1483-84 (Fed.  Cir. 1998) (discussing Super Sack and
Spectronics). Al- though the district court here correctly noted that
the Feder- al Circuit was confronted only with cases in which the
plain- tiff sought a declaratory judgment in order to avoid litigation
 and liability for infringement, and did not consider whether  such a
decision would have any collateral effect or additional  significance
under the ANDA statute, the relevant consider- ation is the estoppel
of the patent holder from later claiming  that the ANDA applicant is
liable for patent infringement.


Put otherwise, the California dismissal appears to meet the 
requirements of a triggering "court decision" because that  court had
to make a predicate finding with respect to whether  Syntex would ever
sue Teva for infringement in order to  conclude that there was no case
or controversy between the  parties. In dismissing Teva's complaint
for lack of subject  matter jurisdiction, the California court
expressly found that  Teva "lacks a reasonable apprehension of suit by
Syntex for  infringement of [its patent]." According to Syntex's
motion  to dismiss Teva's complaint, that finding could only have been


based on the patent holder's declaration of counsel and its  June 8th
letter to Teva. Although the dismissal was not a  judgment on the
merits after consideration of evidence pre- sented by the parties,
there was no need for such a procedure  here because the dismissal
sufficed to estop Syntex from  suing Teva for patent infringement. See
Super Sack, 57 F.3d  at 1059; Spectronics Corp., 940 F.2d at 638. This
is the  result that appears to be the purpose of the triggering "court
 decision" provision. A contrary view, as Teva contends,  means that
the patent holder could manipulate the system in  order to block or
delay generic competition by stating that  the patent holder will not
enforce its patent against the  Paragraph IV challenger. See Mova, 140
F.3d at 1073 &  n.18. For these reasons, the California dismissal
would ap- pear to meet the requirements of a "court decision" under  s
355(j)(5)(B)(iv)(II). On remand, of course, the FDA will  have the
opportunity to explain why it fails to meet them.


Second, it is unclear that a triggering "court decision" need 
explicitly hold the patent at issue is "invalid" or is "not 
infringed" in order to trigger the 180-day period of market 
exclusivity. Both the FDA and the Federal Circuit recognize  that a
certification that a patent is "unenforceable" suffices  for purposes
of the Paragraph IV certification, see 21 C.F.R.  s
314.94(a)(12)(i)(A)(4); Merck & Co. v. Danbury Pharmacal,  Inc., 694
F. Supp. 1, 2-3 (D. Del. 1988), aff'd, 873 F.2d 1418  (Fed. Cir.
1989), even though the statute provides that such  certification must
state that the patent is "invalid" or "will not  be infringed," see 21
U.S.C. s 355(j)(2)(A)(vii)(IV). When it  promulgated the final
regulations on ANDA applications, the  FDA explained that it included
"unenforceability" because  "[t]he alternative interpretation,
precluding applicants chal- lenging patents as unenforceable from
filing certifications  under paragraph IV, would be contrary to
Congress' obvious  intent in allowing patent challenges under [ANDA]
and would  lead to absurd results." 59 Fed. Reg. 50,338, 50,339
(1994).  Likewise reflecting the same concerns, see id. at 50,353, the
 FDA regulations provide that a "court decision" need not hold  the


may hold the patent unenforceable, see 21 C.F.R.  s 314.107(c)(1)(ii)
(Westlaw 1999).


Intervenors' attempt to assert that unenforceability, which  is
included in the regulation, and estoppel, which is presented  here,
should be treated differently under s 355(j)(5)(B)(iv)(II)  is
unpersuasive. Although it is true that a determination of 
unenforceability, such as for inequitable conduct, applies gen-
erally, preventing the patent holder from enforcing the patent 
against any entity, see Elk Corp. of Dallas v. GAF Bldg.  Materials
Corp., 168 F.3d 28, 30, 32 (Fed. Cir. 1999), and the  estoppel arising
from the California dismissal operates only  against Syntex as to
Teva, see generally 18 Charles Alan  Wright et al., Federal Practice
and Procedure s 4443, at  381-91 (1981); see also Cotton v. Heyman, 63
F.3d 1115, 1119  (D.C. Cir. 1995), this appears to be a distinction
without  difference for purposes of the "court-decision" requirement. 
To start, or trigger, the period of market exclusivity by a  "court
decision," an ANDA applicant need only obtain a  judgment that has the
effect of rendering the patent invalid  or not infringed with respect
to itself; the statute does not  require, nor does any party contend
that it requires, the  patent to be invalidated as to any and all ANDA
applicants.  See 21 U.S.C. s 355(j)(5)(B)(iv)(II). As the FDA and Tor-
 Pharm concede, Syntex cannot sue Teva for patent infringe- ment as a
result of the California dismissal. In its regula- tions, the FDA
added "unenforceability" to the list of what  qualifies as a "court
decision" because it concluded that  implementing the statute in any
other way would be contrary  to Congress' intent and produce absurd
results. See 59 Fed.  Reg. at 50,353 (referring to 59 Fed. Reg. at 50,
339). Howev- er, the situation presented here appears no less absurd 
because Teva can never be sued by Syntex for patent in- fringement,
but the FDA has nevertheless concluded that the  California dismissal
cannot satisfy the "court decision" re- quirement of the statute.
Thus, the FDA's application of the  statute to this case runs counter
to its explanation for permit- ting unenforceability to qualify as a


Third, the FDA's treatment of the California dismissal  appears
contrary to the FDA's "Guidance for Industry" in 


two respects. Cf. Cherokee Nation of Okla. v. Babbitt, 117  F.3d 1489,
1499 (D.C. Cir. 1997) ("An agency is required to  follow its own
regulations.") First, the FDA has effectively  declined to proceed on
a "case-by-case basis," proposing  instead to consider Teva's
interpretation as part of the rule- making process. Although the FDA
generally has discretion  to determine whether to proceed by
adjudication or rulemak- ing, see Mobil Oil Exploration & Producing
Southeast Inc. v.  United Distribution Cos., 498 U.S. 211, 230 (1991);
SEC v.  Chenery Corp., 332 U.S. 194, 203 (1947); Arkansas Power & 
Light Co. v ICC, 725 F.2d 716, 723 (D.C. Cir. 1984), litigants  also
have a right to adjudication of their claims, see AT&T v.  FCC, 978
F.2d 727, 731-33 (D.C. Cir. 1992). The FDA has  been mute in response
to Teva's request for a complete  explanation of the rejection of its
interpretation. Noting the  language of the statute, its purposes, and
ambiguities, the  FDA has recognized in its brief to this court, as
the court in  Mova did, see 140 F.3d at 1073 n.18, that a dismissal
could be  sufficient to satisfy the "court decision" requirement. See 
Federal Appellee's Br. at 20-21. Yet, the FDA says in its  brief that
it is "not at this time prepared to conclude that  dismissal of Teva's
declaratory judgment action for lack of  subject matter jurisdiction
is a 'decision of a court' under  section 355(j)(5)(B)(iv)(II)." Id.
at 20. Contrary to the  FDA's view, nothing in our decision in
Purepac, 162 F.3d  1201, relieved the FDA of its obligation to abide
by the  commitments it made in the "Guidance for Industry" as to  how
it would proceed until a new rulemaking was completed.


How the FDA can justify this approach to Teva's interpre- tation of the
California dismissal in light of its treatment of  other cases remains
a mystery; presumably in a "case-by- case" analysis the FDA is
obligated to explain such differ- ences. See ANR Pipeline Co. v. FERC,
71 F.3d 897, 901  (D.C. Cir. 1995); Pontchartrain Broad. Co. v. FCC,
15 F.3d  183, 185 (D.C. Cir. 1994). Specifically, the FDA has not 
explained why it would recognize a grant of partial summary  judgment,
based on the patent holder's admission of non- infringement, as a
"court decision" in Granutec, 1998 WL  153410, at *5, but decline to
give similar effect to a dismissal 


based on a finding of no reasonable apprehension of suit  arising from
the patent holder's admission of non- infringement. In Granutec, the
FDA argued that the partial  grant of summary judgment in a prior case
satisfied the  "court decision" requirement. See id.; see also Glaxo,
Inc. v.  Boehringer Ingelheim Corp., 954 F. Supp. 469 (D. Conn.1996), 
final judgment entered, 962 F. Supp. 295 (D. Conn.1997),  aff'd, 119
F.3d 14 (Fed. Cir. 1997) (unpublished opinion).  That Boehringer
involved a judgment on the merits, while  Teva's complaint was
dismissed for lack of subject-matter  jurisdiction, does not detract
from the fact that both proceed- ings prevent the patent holder from
suing the ANDA appli- cant for patent infringement. Given that the
California dis- missal supports estoppel to the same extent as the
grant of  partial summary judgment at issue in Granutec, it is unclear
 why the California dismissal would not satisfy the "court  decision"
requirement of s 355(j)(5)(B)(iv)(II). At least the  FDA has not
provided an explanation wherein there is a  material difference for
purposes of triggering the "court  decision" provision.


Second, the FDA's response to Teva's interpretation of the  "court
decision" requirement is not easily viewed as "regu- lat[ing] directly
from the statute," as the FDA committed to  do in its "Guidance for
Industry." The FDA "acknowledges  that its current interpretation of
the court decision trigger is  narrower than the statute may be able
to support.... [and]  that Teva's interpretation of the court decision
trigger may be  permissible." Yet if the FDA's interpretation of
section  355(j)(5)(B)(iv)(II) is "narrower than the statute [is] able
to  support," then its interpretation cannot stand without justifi-
cation because the FDA must interpret the statute to avoid  absurd
results and further congressional intent. See Robin- son v. Shell Oil
Co., 519 U.S. 337, 346 (1997); R.G. Johnson  Co. v. Apfel, 172 F.3d
890, 895 (D.C. Cir. 1999). A narrow  interpretation cannot be
reasonable simply because it is nar- rower than it could be; to the
contrary that interpretation  may in fact be narrower than it should
be given the purposes  of the statutory scheme and congressional
intent. See Pro- cess Gas Consumers Group v. United States Dep't of


ture, 694 F.2d 778, 792 (D.C. Cir. 1982) (in banc); see  generally Oil,
Chemical & Atomic Workers Int'l Union v.  NLRB, 46 F.3d 82, 90 (D.C.
Cir. 1995); Association of  Civilian Technicians v. FLRA, 22 F.3d
1150, 1153 (D.C. Cir.  1994). It is the narrowness of the
interpretation that must be  justified, and the court can only review
that choice of narrow- ness based on the reasons provided by the FDA,
see Chenery,  332 U.S. at 196; here, it has provided none.


As a result of the FDA's current construction of the "court  decision"
requirement and its treatment of Teva's application,  generic
ticlopidine tablets were not available in the market- place for a
number of months despite the fact that appellants  both stood ready to
market them. Syntex remained the  exclusive manufacturer of "Ticlid,"
and the first ANDA appli- cant's market exclusivity period had not
begun because the  FDA had yet to approve that applicant's filing. On
July 1,  1999, the FDA finally approved TorPharm's ANDA, and  TorPharm
commenced marketing on July 6, so now at least  one generic version of
ticlopidine tablets is available.8 Yet,  this series of events may
well not have been what Congress  contemplated in enacting the
Hatch-Waxman amendents to  expedite generic drug approvals. See H.R.
Rep. No. 98-857,  pt. 1, at 14-15, reprinted in 1984 U.S.C.C.A.N.
2647, 2647-48;  cf. Mova, 140 F.3d at 1073. Be that as it may, our
decision to  reverse the denial of injunctive relief rests on the
FDA's  failure to explain adequately its refusal to treat the
California  dismissal as a triggering "court decision" under  s
355(j)(5)(B)(iv)(II), particularly in view of its announcement  in its
"Guidance for Industry" of how it would proceed  pending a new




__________

n 8 The FDA's approval of TorPharm's ANDA does not moot this  appeal
because Teva sought a preliminary injunction against the  FDA
compelling it to deem Teva's application effective as of Febru- ary
10, 1999. Though Teva will be able to market its ticlopidine  tablet
180 days after July 6 without fail, in the interim Teva and  Purepac
face continued harm because of their denied access to the  market, see
Byrd v. EPA, 174 F.3d 239, 244 (D.C. Cir. 1999), harm  potentially
heightened because of TorPharm's period of market  exclusivity.


correct that Teva's interpretation is not the only permissible 
construction of the "court decision" requirement, Teva has 
demonstrated that the FDA's refusal to treat the California  dismissal
as a trigger was arbitrary and capricious in light of  the FDA's
response in another case.


Accordingly, we reverse, and because our conclusion could  well affect
the district court's evaluation of appellants' other  arguments
concerning harm, injury, and the public interest,  we remand the case
to the district court to consider anew the  request for injunctive