*1 Hopkins’s loath to reward conduct with an partnership,
award of the alternative reme- dy of pay unrestricted front is even less and, satisfactory as the district court ob- served, restraint, “might considerable provide well wholly unwarranted wind- fall.” F.Supp. at 1211. record,
Based on the entire I am doubtful judgment of the district court justice. achieves Nevertheless, because my skepticism falls somewhat of “a short definite and firm conviction that a mistake committed,” I required am concur in the majority’s affirmance of that judgment. LABORATORIES,
ABBOTT Appellant, YOUNG, Dr., Commissioner, Frank D. Drug Food and Administration. Nos. 88-5260. United States Court of Appeals,
District of Columbia Circuit.
Argued Sept. Dec.
Decided
Co.,
5. See United
Gypsum
it,
States v. United States
support
there is
reviewing
evidence to
364, 395,
Opinion the Court for Judge SILBERMAN. by Circuit
Dissenting Opinion filed Judge EDWARDS.
SILBERMAN, Judge: Circuit both case which is an This unusual present us government appellant and of a stat- interpretations unreasonable with therefore ambiguous. We we think ute remand to court to the district direct for reconsideration.
I. Drug 1984, Congress enacted
In Term and Resto Competition Patent Price Act, 98 Stat. No. Pub.L. ration (the Amend “Hatch-Waxman Food, Drug, ments”), amending the Federal Act, 301-392. 21 U.S.C. §§ Cosmetics and pro for system a new statute created interests of manufac tecting both the drugs and the produce who turers manufacturers generic drug interests Facing the classic consumers. their trade-off be appropriate question the invention for greater incentives tween affordability greater products newof Congress struck a bal products, those drug ap generic expediting ance between the interests protecting plications H.R. manufacturers. original (Pt. 1), Cоng., 2d Rep. 98th No. 98-857 1984 U.S.Code reprinted in Sess. Jr., Robert Murry, with whom D. Harold re It Cong. brief, appellant. for & Admin.News on the P. Rezniek of market exclusivi period longer a served D.C., also Yolles, Washington, Bryan Jay drugs than for developed ty newly for appellant. appearance, entered process had drugs for which Dept, of Jus- Solet, Attorney, M. Irene applica prior a completed in already been Gerson, Asst. M. tice, Stuart whom original gives the The statute tion. Atty., and Stephens, U.S. Gen., Jay B. Atty. ex of market period specified producer D.C., Washington, Steinmeyer, J. Anthony phar primarily clusivity depending brief, Justice, on the were Dept, of Atty., drug. novelty of maceutical Atty., Eagle, H. Jacqueline appellee. us to determine requires This case Justice, en- also Md., Dept, of Rockville, par- exclusivity provisions, scope appellee. appearance, tered an phrase “active meaning of the ticular D.C., for Mathers, Washington, R. Peter ester or salt (including Pharmaceutical, Inc., Par curiae 21 U.S.C. amicus ingredient).” affirmance. urging (v). full 355(j)(4)(D)(i) margin, but out is set subsections the two relevant EDWARDS, key parts MIKYA, Before year exclu- state SILBERMAN, Judges. Circuit sivity period to drug attaches whose new approved Abbott’s new drug application drug application (“NDA”) “includes an ac- (“NDA”) for another Depakote, also (including any ester or salt prescribed for control of seizures. In ingredient) ap- that has been Depakote NDA, Abbott *3 exclusively relied proved in [NDA],” another 21 U.S.C. on the safety and efficacy findings estab- 355(j)(4)(D)(v) year § and a ten exclusivity in lished the course prior of the Depakene period attaches to drug a whose NDA has application, bеcause the “active moiety” of “no active ingredient (including any ester Depakote very was the same valproic acid. or salt of the ingredient) active of which Depakote’s active ingredient, told, we are is has been approved other [NDA],” 21 divalproex sodium which is converted into SSSQ^XDXi).1 U.S.C. § thereby valproic acid within the body. human sought to encourage innovation Apparently divalproex presents sodium industry, by rewarding pioneer drug with gastrointestinal fewer side effects than the a ten year exclusivity, while protecting con- valproic Although acid. the issue was dis- sumers unduly from high prices by re- puted, the agency found divalproex sodium fusing give a long period of market to be a salt of valproic acid.2 In simple exclusivity to drugs which required no new terms, a salt is a chemical compound research cre- effort. ated when the “parent” substance reacts In 1978 the Food and Drug Administra- with another chemical. A salt is “formed (“FDA”) tion approved for marketing Ab- when the hydrogen of an acid replaced bott (“Abbott”) Laboratories’ ap- new drug by a metal equivalent.” or its Glaxo Oper- plication Depakene, an anticonvulsant ations UK Ltd. v. Quigg, 392, drug prescribed for control epileptic and n. (Fed.Cir.1990), citing The other seizures. Condensed The chemical ingredient of Chemical (G. Depakene Dictionary 907 performs Hawley rev. the drug’s thera- 1981). 10th peutic ed. FDA valproic function is determined that acid. De- Valproic pakote only acid is both an could granted ingredient” (the “active year two period substance prior to of market exclusivity introduction into pursuant the hu- body) man and an moiety” (the sub- because it was of the stаnce that creates the therapeutic actual active prior-approved De- effect within body). 1982, In pakene. 29, August On 1986 Abbott sub- (other application If an than an abbreviated (b) for which the subsection appli- drug application) submitted under subsec- cation was submitted or which refers to a (b) tion this drug, section for a change no active approved supplement in a to the sub- ingredient (including any (b) ester or salt application section effective before the ex- ingredient) piration which years of two September 24, from application (b) other under subsection section, this approved during 355(j)(4)(D)(i) was 21 added). period (v) U.S.C. (emphases and 1, beginning 1982, January ending and Sep- (D)(i) (D)(v) tember Both Secretary may and make transition period approval 1, application under the January an submitted under Seрtember 24, 1984, during subsection which which refers the ten year year (b) exclusivity which periods application apply. subsection was sub- (D)(ii), (iii), (iv) Sections mitted effective expiration appli- before the control of ten exclusivity cable periods years September from the after approval date of the appli- 1984. Because the (b) during instant case cation under arose of this section. period, (D)(i) transition (D)(v) are at (v) (or application If an supplement issue here. We note that the same application) (b) submitted under subsection determining used for applicable periods of this section for a which includes an exclusivity Septem- introduced after active ingredient (including any ester or salt ber 1984—the only difference in the statu- ingredient) of the active ap- that has been tory scheme is the lеngth peri- proved application in another under subsec- ods. (b) section, of this approved during period beginning January 2. The FDAbased its decision about the chemical ending September Secretary relationship between Depakene may not make the of an part on an affidavit submitted Dr. Robert H. submitted under Wood, this subsection which refers given which Abbott was not notice. Indeed, suggested least it was at pursu- the FDA Petition to a Citizen mitted letter, subsequent to the deci agency a ten requesting 10.30 ant to C.F.R. § case, phrase “ac in Abbott’s sion FDA denied Abbott’s exclusivity. The year itself, even without Labs, Docket No. 86P-0367 petition, Abbott interpreted to in could be 1988), parenthetical, filed and Abbott (FDA February notwithstanding moiety from clude appeals It in the district court. a suit narrowly in FDA construes term agen- affirmed the judgment below act, 335(j)(4)(D). section оf Young, 691 another Labs. cy decision. No. Pharmaceutical Docket McNeil (D.D.C.1988). F.Supp. 462 26,1989). (FDA July 87P-0339 *4 pur the different to contend that appears II. 335(j)(4)(D)(pro section pose that other guid- Supreme Court’s to the Pursuant generic expedited viding for Chevron, first determine we must ance indicated) justi is agency caution so an “unam- Congress manifested whether same interpretation of the fies different that resolves expressed intent” biguously impermissi it is not phrase. We note that meaning. dispute over the agency to inter Chevron for an ble under Resources v. Inc. Natural U.S.A. differently in two imprecise term pret an Council, Inc., 842- Defense have a statute which separate sections of 2781-82, 694 81 L.Ed.2d 43, 104 S.Ct. National Ass’n See purposes. different course, language of the (1984). Of v. Board Surety Agents Casualty and always best indication is statute itself Sys., Reserve 856 the Fed. Gоvernors of argues, intent. Abbott congressional (D.C.Cir.1988) (upholding dif 287 F.2d Circuit, Federal support with interpretations of same ferent language meaning” of the “plain explanation), reasonable based on phrase when interpretation. Both supports its denied, U.S. 109 rt. 490 ce Glaxo, Circuit, 894 see Federal and the Pro (1989); Comite L.Ed.2d phrase only on the focus F.2d Auth., v. Sewer Rescate claiming it has a well ingredient,” _ denied, cert. Cir.1989) (same), (1st court, on district meaning. The understood _, 108 L.Ed.2d usage of hand, thought that the the other whether consider (1990). But we cannot which,” “which,” “of words the reference a term because ingredient is such active (v) (i) created an “that” sections on Ab its decision agency did not in con- an overlap therefore irreconcilable theory. employ this bott’s the same the sections flict between the rela a moment Putting aside for ostensibly covered ingredient was active of constructions of the various tive merits peri- in different resulting provisions, both is fered, first conclude for the same exclusivity mandated ods of before to the issue it relates ambiguous as The at 472. F.Supp. substance. (“including phrase parenthetical judge’s us. the district disavows government ingredient”) active Instead, or salt any ester conflict.3 irreconcilable perceived ingredient of to either active can refer parenthetical reads government drug or to the active original any ester or salt (“including phrase drug, depending in the ingredient interpreta- permit ingredient”) active and the in the parenthetical “the” how includes tion of “active parenthetical surrounding the words derivatives. or ester than salt even more —"no of which ingredient ... phrase active Aсcording government, to the words, In other interpreted. Congress approved” interpreted to mean can be —is as ingredient active of an the definition ingredient loose- using term active was and an ingredient including the active both synonym for active as a virtual ly, possibly can ingredient of active ester or moiety. interpretation meets agency's agency’s judge’s construction the district 3. Of course —if standard. the Chevron deference entitled to is not refer both active in the government’s er construction falls earlier and the- application, later within the bounds of reasonableness. We proper be the reading if Con- think does not —at least primary argu gress mind, had, had as it seems to have presented ment before us does not. The that an active regard- to be “reasonableness” of an construc еd for purpose portion of this of the statute depends tion on the construction’s “fit” equivalent to an ester or salt of itself. with statutory language as well as its conformity purposes. We can Act, In this section of the Congress was agree government’s uncon defining concerned with entity chemical vincing attempts to employ the “including” (j) which a subsection (generic drug) possible clause cover all permutations application is based.4 When used ingredient. active This case “an definition differs from ingredient (or where instances of “including” salt or ester clause ingredient),” designed 355(j)(4)(D)(v) merely (emphasis added), illustrate a few exam that defi- ples of the general category, see, nition arguably e.g., to all the subsec- referred Puerto Rico (b) Maritime applications Auth. question. Shipping *5 ICC, (D.C.Cir. FDA’s F.2d 1112 n. approve authorizatiоn to generic (subsection 1981). simply It is (j) plausible application) depends to read “including any its relationship salt or original (sub- to all ester” merely as illustrative, (b) applications). section mean including any form Therefore, Con- gress eventually that may produces have intended for its same active definition moiety. —“an active words, In other ingredient (including reject we government’s or interpretation linguisti the active ester ingredient),” as cally infeasible 355(j)(4)(D)(v) though even logically possi refer the universe of —to ble. (b) all subsection applications. Thus, the ambiguity of phrase reference re- Once reject we inter flects the possibility that it can refer to the pretation of the statute as unreasonable it (b) latest subsection application as well as does not follow appellant’s compеting all prior (b) applications. subsection Al- construction adopted. must be Even if we though dissenting colleague our asserts the appellant’s thought interpretation were language has a meaning, he does not reasonable we accept could not it if we explain why we are incorrect in perceiving perceived still possible other reasonable this ambiguity.5 is, constructions. It all, after for agen cy to make the choice between such alter
III. natives. But in this case we do not believe Since we have nothing discovered suggested Abbott’s interpretation is rea legislative history that could be sonable. thought embody express intent that language yield, pass does not on to argues Abbott even divalproex step second ask wheth- sodium is a salt of valproic acid,6 the stat- (b) applications Subsection ap- manufacture, use, are new drugs" applies sale of plications original for drugs, while subsection provisions regulating drugs individual or to (j) applications generic drug applications are entirety parts regulat- Act which has which face reduced approval. ing barriers to FDA drugs). In that pick case the Court had length of market simply way deter- between a more natural mines lowed, (j) application when a yielded subsection implausible is al- meaning, and an inter- by by which determined reference pretation gave phrase the unclear "a mean- drug application original i.e., drugs, ing simply it will not bear.” Id. 110 S.Ct. at (b) applications. 5. We note that the ambigui Act includes other divalproex 6.The found sodium is hinging ties Lilly unclear references. See valproic Eli a salt of but acid Abbott continues to _ Medtronic, Inc., U.S. _, & Co. v. deny partly it. This is a substantive chemical (structurally L.Ed.2d 605 question un partly procedural issue—-wheth- clear whether "a regulates law which Federal er improperly relied on an affidavit Thus, inter- under Abbott’s treating valproic acid. FDA from precludes ute manufactur- pharmaceutical if a ingredi- pretation, same active as the chemicals one a salt drugs, usable applica- developed two er sequence ent other, protection gain extra he could sure, interpretation, Abbott’s tions. To first, lin- acid by applying more obvious reading, is the first salt, not under the ac- by the statute —that but followed guistic construction in this case to dival- sequence. ingredient refers reverse phrase parenthetical sodium. proex sequential truly If intended or salt the active any ester (“including urges, it would have distinction that Abbott, refers according to ingredient”), draft) quite (it have drafted had ingredi- the active original only to the in a different structure different approved.” “of which ent such then, unlike under application Abbott’s If an submitted subsec- purpose. the form drug application fails obtain That construction thetical reason wanted the a new lative does the fall Abbott’s terests of tical any of the received to in a rational nomenclature. grant then, depend on explanation when any case Abbott depending FDA’s, industry nor scientific, the counsel could goal: pressed on of a entirely extended valproic acid after it serve of a reading promotes reverse, It would mean is not consistent in its turn on (b) ten why Congress way, producing instead Abbott can degree interest sought an research-oriented salt, drug compаny technical, temporal sequence applications on an serendipitous any conceivable year possible haveWe why has an non-salt appears this this variable market generic drug Congress groups) would in this accident of point. advance that if an economic linguistically not first not been would intend *6 to be farfetched form, with were neither exclusivity to merely filing suggest ingredient case, applying pharmaceu It (or indeed sequence.7 any legis but an active approved no chemical in which industry appears, or other original a offered for the a wind the in cannot hypo drug have if it can. but this for first did not focus application; not man which the norm a guage that occurred address rectly ciary) is entitled sue,” construction remand district contained contains an sequential distinction. рroved ification. then.... proved drug, but dient the an active ester or Accordingly, [*] does not subsequent Chevron, and therefore (b) to That Abbott’s typically is filed court of this section drug includes an ester salt of the ‡ particular ingredient in in a For suggests active with have mind here; agency. We we as an active set forth purposes of this that previously appears when NDA, [*] the reverse to remand instructions, “precise question in the ingredient ambiguous statute. in the event that interpretation original active place situation. to us intended is for a there is [*] FDA Ambiguity of lan in the statute 843, 104 this approved drug, previously the manner that previously hold (not sequence [*] that is also drug case to did not di no reasonable to section an or salt of We Congress only that disqual- turn, address drafts passes ingre- [*] think at is judi will ap- ap- in at to judge's a district to did refer Abbott’s brief Since brought Abbott. to the attention not deriving or salt ester speculation that give remanding event to are we the reverse greater than requires effort acid parse to agency opportunity Quigg, Operations UK Ltd. Glaxo process, see might choose to again, the (E.D.Va.1989), n. F.Supp. 1229-30 706 aff’d, any need procedure would obviate adopt (Fed.Cir.1990), the dis- but it re- if affidavit issue us consider notion support no offered court trict and at oral decision. mains relevant counsel, when argument Abbott’s hypothesis. asked, put forth that did not ambiguous; statute is the reliance the gastrointestinal harmful side-effects in government places on including clause patients. some side-effects, To avoid these is an unreasonable construction and that subsequently developed a new Abbott’s statute is called “Depakote,” which was also also Beyond that, unreasonable. may effective controlling seizures but which proceed since we have no authority to used a different place a construction on the statute that the prone was less irritating patients’ diges- agency has not Thus, offered. tive tracts. although the similarities, bear chemical Depakote repre- EDWARDS, HARRY T. Judge, Circuit significant sents a improvement over the dissenting: drug. earlier Abbott filed a new application for PROLOGUE approval to in December This is a bizarre Every case: reasonable of 1981. The new consideration furnishing basis judg- on March Thereafter, on Septem- ment appellant; yet, favors majori- ber Congress passed the Drug ty bring cannot itself to reach the result Price Competition and Patent Term Resto- compelled by the record before it. Act, rаtion Pub.L. No. 98 Stat. 1585 We reject the decision of the District (1984) (the “Act” or “the Hatch-Waxman Court, for it fails comport Amendments”), which was intended to al- statute_ terms of the recog- We also low a manufacturer to obtain nize that the FDA—the agency to which we market a performing without clinical owe deference analyzed case is un- normally required tests support a full “step der U.S.A., two” of Chevron Inc. v. drug application and, also, provide NRDC, 81 market exclusivity for drugs ap- innovative L.Ed.2d 694 not subscribe to proved by —does the FDA. Under Title I of the rationale underlying the District Act, there are categories five of drugs eli- Court’s reject decision.... We also gible for periods varying of market exclu- *7 interpretation, it, too, FDA’s because is at sivity ranging years from two years. to 10 odds with the of the statute and Relying on 355(j)(4)(D)(i)(here- U.S.C. § does not permissible otherwise reflect a inafter (i)”), “subsection applies which to disputed legislation.... We drugs approved by the FDA between Janu- agree with the District Court that Abbott’s ary September 24, 1984, Ab- supported by the lan- bott sought years exclusivity market guage although the majority the Depakote. finds this unpalatable_ And, result fi- (i) Subsection applies to “a no ac- nally, today our decision is in direct conflict ingredient (including any ester or salt judgment with a of a sister circuit. See of ingredient) the active of which has been Operations Glaxo UK Ltd. Quigg, approved application”; other F.2d (Fed.Cir.1990). Abbott claimed prior approval that the Despite foregoing, all of the majority the Depakene did not 10-year bar has decided remand this case to the Depakote, because the ingredi- “active agency give it another shot at the issue. ent” for the is different and This no makes sense me. because the drug’s latter ingredient
(including any
it)
ester
salt of
had never
approved
before been
by the FDA. The
In
the Food
Drug
Administra-
rejected
claim,
FDA
applying instead
(“FDA”)
tion
approved a new anticonvul-
the two-year market exclusivity protection
sant drug, called “Depakene,”
had
355(j)(4)(D)(v)(hereinafter
21 U.S.C. §
developed
been
appellant,
the
(v)”),
Depakene
“subsection
because
(“Abbott”). Depakene
Laboratories
was Depakote
“shared
same
moiety.”
effective in controlling seizures but caused
Appellee
Brief for
words,
at 9.
In other
name-brand
Congress held out to
incentives
literal terms
ignored the
trade-off,
concerns
pharmaceutical
moiety”
“active
(focusing on
statute
pioneer
because,
exclusivity for the
namely,
market
ingredient”),
place of “active
During the
bring to market.
drugs they
“to
view, Congress intended
exclusivity, the FDA will
period
pro-
of market
of market
period
the maximum
provide
any generic copy.
approval of
drugs withhold
innovative
most
only to the
tection
largest expenditure
require the
which
assessing
applicability
In
of subsec-
14. The
develop.”
Id.
resources
(i) (the
versus sub-
10-year provision)
that “active
concedes
agency
(v) (the
two-year provision),1
section
same; and
not the
moiety” are
“active
drug
new
question is whether the
critical
provi-
statutory
to no
point
can
sought con-
exclusivity is
placed
has
gloss
supporting
sion
(including any
an “active
tains
(i).
on subsection
ingredient)”
of the active
or salt
ester
approved by
FDA’s
the FDA.
shunning
previously
majority,
while
(v)
355(j)(4)(D)(i)&
construction, agrees
the con-
U.S.C.
(1988),
§§
(in-
only
drug’s
“active
should obtain
If the new
Depakote
clusion that
in-
pro-
or salt of the active
cluding any ester
shorter, two-year period of market
approved by
previously
judgment,
gredient)”
been
reaching this
has
In
tection.
FDA,
FDA,
is entitled
ignores
then the
like
majority,
under
subsection
years’
it believes
statute because
to two
meaning
written,
not,
drug may claim
statute
then
(v);
if it has
that,
enforced
exclusivi-
period
I dissent
of market
10-year
results.
arbitrary
the full
produce
being
(i),
rationale
majority’s
ty
conclusion
under
I believe
sig-
likely represents a more
conjecture,
groundless
that the
largely
is based
judges
innovation.
task
nificant
it is our
and because
written, not as we
as it
apply the
agree
Depakote,
parties
All
been written.
ought to have
think it
exclusivity,
seeks market
for which Abbott
previ-
many
Abbott’s
similarities
bears
I.
drugs are
Depakene. Both
ously
both do
seizures and
control
notes,
prescribed
correctly
majority
As the
moiety,”
a common
by way of
so
were
Amendments
Hatch-Waxman
agent
significant
i.e.,
pharmacologically
emerged
compromise.
Act
product
the intended
accomplishes
actually
two con-
to balance
efforts
Congress’
body. The
in the human
therapeutic effect
name-
to induce
objectives:
flicting policy
and De-
for both
*8
moiety”
“active
to make
firms
pharmaceutical
brand
valproic
as
known
a substance
pakene is
and de-
necessary to research
investments
development
innovative
The
acid.
chief
simulta-
products, while
velop new
Depakene’s
modification
Depakote is a
bring
competitors
enabling
neously
ingredi-
i.e.,
form,
“active
its
dosage
initial
drugs to
of those
generic copies
cheaper,
side-effects
ent,”
undesirable
that avoids
Pharmaceuti-
Mead
market. See
Johnson
Depakene uses
Depakene.
1332,
1333 associated
Bowen, 838 F.2d
Group v.
cal
“active
its
857,
valproic
acid
98th
H.R.Rep. No.
(D.C.Cir.1988);
—in
moiety” di-
the “active
introducing
14-15,
effect
1,
reprinted
Sess.,
at
pt.
2d
Cong.,
was
approach
body. This
Cong.
rectly into
& Admin.News
U.S.Code
but result-
controlling seizures
effective
statutory provisions
2647,
The
2647-48.
side-effects, leading
gastrointestinal
ed in
one of the
reflect
directly at issue here
Depakote,
(1988). Abbott's
355(j)(4)(D)
(v),
(i)
U.S.C.
at issue
subsection
and
1. Subsection
exclusivity is
by
claim market
here,
drugs approved
whose
only
to new
action,
approved on March
from Janu-
during
"window”
in this
a transitional
contested
24,
Drugs
protection is
through September
right
ary
market
(i)
are entitled
September
or
by
apрroved after
subsection
governed
either
therefore
periods of
exclusivi-
market
generally shorter
(v)
to
ty
Act.
(iv)
(iii)
(ii),
subsections
under
develop Depakote.
Depakote
there is an irreconcilable conflict between
substance,
uses a different
known as dival-
the two obviously complementary statutory
proex sodium, as its
ingredient.
Di- provisions, must
rejected.
also be
I dis-
valproex sodium avoids the
agree, however,
side-effects as-
with the majority’s dis-
sociated with the direct ingestion of
covery
val-
of a
purported
new
ambiguity in the
proic acid.
divalproex
Once
statute,
sodium is in-
a discovery it uses to justify a
gested, however,
body
converts it into
remand
the FDA (along with a strong
valproic acid, which then accomplishes the
hint about how
should construe
intended effect of controlling
(i)
seizures.
(v)).
subseсtions
Rather,
I believe
this case is properly
resolved
the first
valproic
Although
acid was previously
step of the familiar
doctrine,
un-
approved in Abbott’s
earlier
der
court must adhere to the
Depakene, it is
by
parties
conceded
all
Congress
clear intention of
expressed on
divalproex
neither
any
sodium nor
salt or
the face of the statute. See Chevron
ester of divalproex sodium had ever been
U.S.A.,
NRDC,
Inc. v.
previously approved by the FDA.
2778, 2781-82,
993
FDA,
majority’s hypothesis.
port or refute the
by the
previously
been
in the record for
simply
is
no basis
compass
into the
There
drug
the
pushing
second
assumption that it is
majority’s blithe
reversing
order
(v). By
of subsection
invented
entirely serendipitous that Abbott
approval
sought,
is
Government
in which
I
loath to
Depakote.
am
Depakene
10
before
could obtain
however, the manufacturer
plain
based
under Ab-
words
ignore
for both
years’
supposition that is
upon
of the stat-
a counterintuitive
language” reading
“plain
bott’s
groundless.
have been apparently
a result could not
ute. Such
intention,
majority
Congress’
within
Second,
sequence of invention
even if the
meaning
concludes,
and
manipulated to the
approval could be
ignored.
therefore be
must
nothing
advantage, there is
manufacturer’s
answers
are
least two
There
at
justify
a result to
outrageous
such
so
about
First,
have no
majority’s argument.
stat-
enforce the
majority’s refusal to
sci-
knowing
for
whether would
basis
it.
it is true
Congress wrote While
ute
the order of
to reverse
entifically plausible
beyond
literal
go
that “a court should
in a case of
invention
pharmaceutical
on that
reliance
language of a statute
reverse
sort,
economicallyfeasible to
purpose of
language would defeat
is
Government
in which
order
statute,”
United
Bob Jones Univ. v.
a “deriva-
suggests that
sought.
Intuition
2017,
103
States,
S.Ct.
461 U.S.
likely
invented
to be
tive”
after
(1983),
Supreme
157
76 L.Ed.2d
way
other
rather than the
“parent”
only
ordinarily applies this canon
Court
capricious,
Indeed,
seem
it would
around.
to a stat-
clear that adherence
it is
where
company
absurd,
pharmaceutical
a
even
produce a result
literal terms would
ute’s
a
attempt to market
develop and
legislative pur-
with
flagrantly at odds
side-effects
harmful
(like
Depakene)
from
that would ensue
The result
pose.2
development of a better
subsequent
market
application
literal
those
that avoided
(like Depakote)
eco-
the maximum
provisions granting
—
there
And in this case
side-effects.
drug that had to endure
rеward to
nomic
orchestrated
danger that Abbott
clearly no
regulatory
amount
than a maximum
less
exploit the
drug applications
its new
likely to
not seem
delay
expense
—does
statutory provisions
given that
statute
plain purpose”
“defeat
retrospectively
only
at issue here
all,
rough
was,
to strike
after
before
that occurred
conduct
generic
accelerating
compromise between
enacted.
was
suffi-
providing
entry into
for continued
incentives
economic
Furthermore,
point,
cient
more to the
sup-
innovation.
name-brand
either
no evidence
parties offered
case,
Laundry
Green v. Bock
Jones,
upheld
In a more recent
example,
Court
In Bob
Co.,
104
tax-ex-
S.Ct.
ruling
interpretive
that restricted
Mach.
an IRS
(1989),
upheld non-liter-
institutions
to "charitable”
the Court
empt
L.Ed.2d 557
status
609(a)(1)
no
contained
though
relevant statute
Feder-
even
Rule
al
that it
held
The Court
strictly
literal restriction.
such
literal
where
Rules of Evidence
al
"plain
depart
proper
the IRS to
disposi-
“an unthinkable
approach
would lead
where
language”
strict
might
the Rule unconstitution-
render
tion”
governmental
provide
language would
of
aid to an
J.,
(Scalia,
concur-
at 1994
id. 109 S.Ct.
al. See
itself at odds
organization that was
ring
judgment).
poli-
public
national
with "a most fundamental
Dep’t
Jus
v. United States
In Public Citizen
S.Ct.
461 U.S. at
cy”
equality.
of racial
tice,
L.Ed.2d
“unmis-
case found
Court in that
2029. The
applica
(1989),
rejected a literal
the Court
that, underlying all relevant
takable evidence
*10
led to
would have
that
of
statute
tion
Code,
entitlement
intent
is the
that
parts of the
Con
of
that Members
conclusion
“outlandish”
meeting certain
depends
exemption
to tаx
polit
"subject[
own
their
gress
]
to
had intended
charity namely, that
of
common-law standards
—
public
intrusion
parties to bureaucratic
ical
seeking
must
tax-exempt status
institution
Id.,
at 2566 n.
oversight.”
S.Ct.
109
contrary to
not be
public purpose and
serve a
586, 103 S.Ct.
public policy.” Id. at
established
at 2025.
994
yields
That a statute
a somewhat anoma
tory compels such a
good
result —even a
lous result
not
Congress
does
mean that
attempt
faith
Congress’s goals
further
could not have
statutes,
intended it. Many
open
way
judicial
hijacking
being products of innumerable and some
of
power
legislate.
hasty
times
pragmatic
compromises, Consolidated Rail
v.
Corp.
States,
United
permit seemingly arbitrary results. See
(D.C.Cir.1990);
579
Dow
cf.
Board
Governors
the Federal Re
of
of
Department
Justice,
Jones & Co. v.
908
Sys.
serve
v.
Corp.,
Dimension Fin.
474
F.2d
(D.C.Cir.1990)
1009
(Silberman,
361, 374, 106
681, 689,
U.S.
S.Ct.
L.Ed.2d
88
J.) (“It may well be
that if Congrеss
true
(1986).
cause,
That fact is not
how had thought
question,
about this
the [stat-
ever, for rewriting them either in
agen
would have been
ute]
more
drafted
broad-
cies or in the
Contrary
courts. See id.
ly....
Congress
not,
But
did
and the
the tenor
majority’s
analysis, Con
simply will
words
not stretch to cover this
gress
subject
is not
to the “arbitrary and situation_”),
denied,
reh’g
No. 89-5353
capricious”
constraints
the Administra
(D.C.Cir.
5, 1990).
Oct.
tive Procedure Act when it
and en
drafts
nothing
There is
in
legislative
history
statutes;
acts
and courts are
free to
not
of the market exclusivity provisions to sug-
withhold
congressional
enforcement of
en
gest the sort of “clearly expressed legisla-
merely
actments
they
seem arbi
tive intention to
contrary”
that is nor-
trary or anomalous.
Motor Vehicle
Cf.
mally required before a court will act to
Ass’n v.
Farm Mut.
State
Auto. Ins.
Mfrs.
override a
plain
meaning. See
Co.,
463 U.S.
43 n.
103 S.Ct.
Burlington Northеrn R.R. Co. v. Okla-
2866 n.
(1983)
lem. tinkering Judicial statutes is, tuality any rate, without factual order to suspected correct congressional support in the record. oversights is, however, dangerous busi- ness: III. In these statutory interpreta- rules [of
tion], Underlying majority’s analysis we courts assume that is the assumption always that if particulars perceive one can knows whereof it speaks; ambiguity in a statute, remote, do assert however that as an empirical fact, slight fanciful, understand, for we all must be said, pushed Horace into the step “sometimes second excel- even Chevron analysis, lent Homer nods.” We hold which the to this court must defer to a course, however, because there reasonable interpretation. is no oth- This dangerous er way; less fundamentally if courts were point misconceives the free to they “correct” what analysis. believe be Chevron sug- does not congressional oversights by gest cоnstruing statutes, courts are search unambiguous statutes to the contrary overturning linguistic brush, rocks their meaning apart hope discovering arguable some am- — specific rare case in legislative his- biguity, which would justify then deference
995 Inc., Cartier, 486 U.S. Corp. v. K Mart The See construction. to an administrative 100 L.Ed.2d step of 108 S.Ct. under the first responsibility court’s plain mean- (“In ascertaining the considerably (1988) seri is more 313 analysis Chevron to “employ[] traditional must look to the court ing is the court ous: issue, to ascer statutory language construction” statutory at particular of tools the had an intention “Congress design of the language and tain whether as as well Chevron, issue.” at question precise whole.”). Indeed, accept the statute as at n. 9. S.Ct. 2781 n. 104 843 467 U.S. at step- that Chevron majority’s proposition imprecision or occasional ambiguities Minor as a court finished as soon analysis is one under Chev may brooked be in in a statute ambiguity perceive can some long as “traditional step, so first ron ’s must be ana- all that statutes would mean Con statutory construction” reveal tools of Chevron’s, second deferential lyzed under v. United NLRB intentions. gress’ lawyers clever step, clever —and Union, Lo Workers Food & Commercial always capable perceiv- of be judges —will 112, 123, 108 S.Ct. 23, 484 U.S. cal statute, mat- any in no ambiguity ing some question pure (“On a L.Ed.2d Congress struggles to em- clearly ter how construction, job is our first statutory the face of the its intentions on blazon intent, us congressional try to determine the Su- clearly not what is statute. That statutory construc tools of ing ‘traditional and it in intended preme Court interpreta so, then can do If we tion.’ in judiciary, hardly leave the effect_”). Advance given must be authority” sense, final as “the meaningful ap not step is second ment to Chevron’s In construction. on issues court stumbles merely where propriate Cardozo-Fonseca, 480 U.S. INS rather, giv ambiguity; perceptible across 1221-22, L.Ed.2d final remains “the judiciary en (who (1987), wrote Stevens Justice statutory construc authority issues of Chevron) strongly the Court in opinion for 9,n. Chevron, at 843 tion,” of a statu- indicates author of that n. abdication at 2781 pure question remains “a tory provision con administrative to an ity and deference to de- the courts statutory construction only where the court legitimate struction is ad- provision at issue even when cide” cannot statute that gap confronts Thus, second ambiguity. mits of some tools of way traditional bridged by be applicable test is step of the Chevron prop which can statutory construction congres- to discern unable a court is when im express an erly be characterized employing traditional after intent sional authority by Congress delegation plied statutory construction. tools 843-44, 104 S.Ct. see id. at agency, an in- case, Congress’ of this 2781-82. On facts provisions in market tention alerted case, majority has In this is “Active absolutely clear. is statute in the ambiguity upon a claimed it does not art and unambiguous term of no other has occurred apparently sug- agency’s moiety.” The include “active Court, not to District reader —not face of contrary flies in the gestion to the charged Abbott, to the not there Nor is the Act. clear terms and not administering the statute Congress’ uncertainty about genuine appeared be- who lawyers Government’s to the to refer statute intention agency. on behalf this court fore announcement majority’s But the sought. exclusivity is in the ambiguity perceive can ambi- purported discovery of majority’s bucking whole grounds for alone articles use of guity real agency. back business as strained is at least “the” “an” and whether, notwithstanding some question is ambiguity finding of Con- language, imprecision arguable entitled “including.” Abbott satisfactorily word cannot intentions gress’ exclusivity for years of market statute. the terms discerned *12 because neither ingredient, its active dival- sodium,
proex nor any ester or salt of divalproex sodium, has ever before been approved by the FDA. Chevron,
Under we are required to ad- here to a plain statute’s terms. Some
courts held that a have statute’s meaning may ignored if there is a clear contrary
direction to the legislative in the history or strict adherence would defeat purpose Congress. clear However, possible neither exception applies in this Therefore, case. I would reverse judg- ment of the District Court and terms in Abbott's favor. LENNON, Appellant,
Robert L. UNITED STATES THEATRE
CORPORATION, et al.
No. 90-7020. United States Appeals, Court of
District of Columbia Circuit.
Argued Oct.
Decided Dec.