WYETH HO LDINGS CORP ., et al., P lai nt iffs,
v. UN ITED STA TES D EP AR TM EN T OF HEALT H AND HUMA N SERVICES, et al., De fend ant s.

UNITED STAT ES DIS TRICT COURT F OR THE D ISTRIC T OF CO LU M BIA

Ci vi l A cti on 08 -00 98 1 (H HK)

MEMORAN DUM OP IN ION Wy e th H old ing s Co rp or a tio n a nd Wy e th ( “ Wy e th” ) b ri ngthi s a c tio n a g a ins t de fe nd ants U.S. Depar

tment of Hea lth and Human Servic es, U.S. Food a nd DrugAdministration, and others (tog ether , “F DA”) under the Administrative Procedur e Ac t, 5 U.S.C. § 551 et seq . (“A PA”) seekinga long er patent term extension for their a nimal drug product (“ Cy dectin”) than that which the FD A has provide d. Be fore the cour t are the FD A’s motion to dism iss or alternatively for summary judgme nt [ #22], and W y eth’s cr oss-motion for summary judgme nt [ #32]. Upon consideration of the cross- motions, t he oppositions thereto, and the rec ord of this ca se, the c ourt conclude s that the FD A’s motion to dism iss or alternatively for summary

judgme nt must be g rante d and that Wy eth’s motion for summary judgme nt must be denied. I. BACKG ROUND B e fo re a ne w a nim a l dr ugmay be mark e te d it s sp on so r m us t su bmi t, a nd the F DAmus t approve , a Ne w Animal DrugApplication (“NADA” ). The N ADA pr ocess pr ocee ds in two phases. F irst, the applicant must conduc t testing a nd an investig ation conce rning the drugTh e se ve n te c hn ic a l se c tio ns are : Ch e mis tr y ; Ma nu fa c tur ingand

Con tr ols ; 1 E ff ec t i v en es s ; T ar getAn i m al S af et y ; Hu m an Fo o d

S af et y ; E n v i ro n m en t al I mp ac t ; L ab el i n g; Fr eedom of

Information Summary ; and All Other Information.

“ An ‘A dmi nis tr a tiv e NA DA ’ i s a ne w a nim a l dr uga pp lic a tio n th a t is su

bmi tte d a ft e r a ll 2 of the tec hnical sec tions that fulfill t he re quirements for the appr oval of the ne w animal drug under 21 C.F .R. § 514.1 have be en re viewed by the Center f

or Ve terinar

y Medicine a

nd the CV M h a s is su e d a

te c hn ic a l se c tio n c omp le te le tte r f or e a c h o f t ho se te c hn ic a l se c tio ns .” U. S. Dept. of H ealth and H uman Service s, Food a nd DrugAdministration, Center for V eter inary Medicine ( CVM), The Administrati ve Ne w Animal Drug Application Process: Guidancefor In du str y , FDA 000107-14, F DA000109 (N ov. 6, 2002) (“ Guidance #132”). 2 (“Te sting Phase” ) with respe ct to seven “ technica l sections” and submit its findings to the F DA. 1 Second, the F DA must evaluate and a pprove the technica l sections (“A pproval Phase” ), and there by approve the drug . The sponsor may submit t he tec hnical sec tions togethe r (trig g ering “Tra ditional Review”) or

in stag es (trig g ering“Phased Revie w”) . In Traditional Review , the Testing Phase ends a

nd the Approva l Phase beg ins when the sponsor c ompletes its investigation and submits all of the technic al sec tions as its final NADA. In Phased Review, the sponsor
su bmi ts t he te c hn ic a l se c tio ns on

a ro lli ngba sis int o a

n Inv e sti g a tio na l N e w A nim a l D ru g fi le (“ I NA D F ile ” ). Th e F DAthe n e va luate s th e se c tio ns on a ro lli ngba sis , is su inga

“ Com ple te L etter” as to ea ch one. O nce the FDAhas appr oved all the tec hnical sec tions, the sponsor may
su bmi t th e fi na l N AD A, kn ow n a s th e Ad min istra tiv e NA DA
. In a

Pha se d Re vie w, it i s le ss 2 clea r whe n the TestingPhase ends a nd the Approva l Phase beg ins. I t is thi s uncer tainty that prese nts the question that underlies this action. I t is a pivotal question because cer tain animal drugpatents, such a s the one in this case , are elig ible for a patent ter m ext ension if patent life was lost while the drugwas unde r re g ulatory revie w. The e x tension leng th is half of the Te sting Phase, 35 U.S.C. §§ 156(c)( 2) and ( g )(4) (B )(i), plus all of the Approva l Phase, not exceedingfive y ear s, see35 U.S.C. § 156(g) (4)( B) (ii).3

In Marc h 1990, Wy eth aske d the FD A to establish an I NAD F ile for Cydectin, a dr ug desig ned to treat and control pa rasites in bee f and da iry

cattle. In April 1990, the F DA
e sta bli sh e d th e I

NA D F ile , w hic h in iti a te d th e Ad min ist rativ e NA DApr oc e ss f

or Cyde c tin a s a Pha se d Re vie w. Wy e th s ub mitte d th e fi rs t te c hn ic a l se c tio n ( Che mis tr y ) f or Cyde c tin in Augus t 19 95 . T he F DAiss ue d a

Com ple te L e tte r f

or thi s se c tio n in

De c e mbe r 1 99 7. Th e re a ft e r, Wy e th
su bmi tte d e a c h te c hn ic a l se c tio n. F or the dura tio n o f t he Pha se d Re vie w, the re wa s n o ti me when a technica l section was not pending ; thus, there wa s no lag in the submissi on of tec hnical sections. ( See Pl. Mot . for Summ. J . [#32] , at 15.) In August 1996, W y eth submitted the final te c hn ic a l se c tio n ( Envir onme nta l Impa c t) , a nd the F DAiss ue d a

Com ple te L e tte r f

or it i n De c e mbe r 1 99 7. At

that ti me , h ow e ve r, a t le a st o ne oth e r s e c tio n ( Pub lic Sa fe ty ) w a s st ill pending , and the F DA re quested supplementa l information from Wy eth. B y J anuar y 1998, Wy eth had submitted all the nec essar y technica l information, and the F DA issued the f inal Com ple te L e tte r o n Jan

ua ry 13 , 1 99 8. Wy e th s ub mitte d th e Ad min ist rativ e NA DAfo r C y de c tin that same da

y . On or a

bout J anuar

y 28, 1998, the FD A issued the mar keting approva l letter for Cy dectin. The dispute in this case a rises in conne ction with Wy eth’s application for a patent term extension based on the re g ulatory revie w proc ess for Cydectin. The FDAdeter mined that the Testing Phase beg an on Apr il 5, 1990, (the date the FDAestablished the I NAD f ile), and that the Approva l Phase beg an on January 13, 1998, (the date Wy eth submitted the Administrative NA DA ). Th e F DAthu s d e te rm ine d th e Te sti ngPha se wa s 2 ,8 41 da y s, and the Ap pr ov a l Ph a se was 16 da y s. Ba sed on these de terminations, the U.S. Patent and Tra demar k Offic e (“ PTO”)
e xten de d th e Cyde c tin

pate nt f ro m Apr il 1 0, 20 07 , to Ma rc h 1 4, 20 11 — a

n e xten sio n o f n e arl y4

four year s. Wy eth disputed the F DA’s de terminations and thus the leng th of its patent term extension. According ly , Wy eth filed a Request for Re vision of the Reg ulatory Review Period with the FDA . Specifica lly , Wy eth contende d that the Approva l Phase beg an upon submission of the first tec hnical sec tion in August 1995, and that the Cy dectin pate nt should be ext ended f rom April 10, 2007, until J anuar y 28, 2012 — approximately ten months longe r than Wy eth’s cur rent extension. Alt ernatively , Wy eth contende d that the Approva l Phase beg an no later than upon
su bmi ssi on of its fi na l te c hn ic a l se c tio n in Au g us t 19 96 , w hic h w ou ld e xten d th e pate nt u nti l November

26, 2011 — approximately eig ht months l ong er tha

n Wy eth’s cur

rent e x tension. The FDAdenied Wy eth’s re quest. Wy eth now see ks a cour t order that would set aside the F DA’s final dete rmination of the re g ulatory revie w per iod for Cy dectin. II. AN AL YSI S The sole que stion before the cour t is the following que stion of law: whether the FD A rig htly decide d that the Approva l Phase beg an upon submission of the Administrative NADA f or Cy dectin. B eca

use the c ourt must review this question under the APA, the cour t only will set aside the F DA’s de cision if it finds that decision to be “a rbitrar y , capr icious, an abuse of dis c re tio n, or

oth e rw ise no t in

a c c or da nc e wi th t he law. ” 5 U .S. C. § 70 6( 2) (A ). Ap ply ingthi s standard, the court turns to the followingstatutory provisions, which establish when the Approva l Phase for Cydectin beg an, and thus de termine the a ppropriate leng th of the pate nt term extension for Cy dectin: (g ) F or the purpose s o f t h i s section, the ter m regulatory

revie w per iod has the fo llo wi ngme anin g s:
***As discussed in Section I , su pra , any patent ter m ext ension would include a ll of the 3 Approva l Phase but only

half of the Testing Phase: (c) The ter

m of a patent elig ible for e x tension under subsec tion (a) sha ll be extended by the time equal to the r egulatory re v i ew period for the approve d product whic h period oc curs a fter the date the patent is issued, ex cept that-

- (2 ) a ft e r any

re du c tio n r e qu ir e d b y

pa ra g ra ph(1 ), the pe ri od

of e xten sio n s ha ll include only

one-ha lf of the time re m ai n i n g i n the per iods describe d in para g raphs (1)( B) (i), (2) (B )(i), ( 3)(B )(i), ( 4)(B )(i), a nd (5)( B) (i) of subse ction (g ); . . . 35 U.S.C. § 156(c)(2)
. 5

(4)( A) In the ca se of a product which is a new animal drug , the term means the period desc ribed in subpar ag raph ( B) to which the lim itatio n in

pa ra g ra ph(6 ) a pp lie s: (B ) T he re g ulator

y re vie w p e ri od

fo r a ne w a nim a l d rug pr od

uc t is the sum of – (i) [Testing Phase] the period beg inning on the e arlier of the date a ma jor he a lthor e nv ir on me nta l e ff

e c ts t e st on the drug wa s initi ated or the date a

n exemption under subse ction (j) of se ction 512 beca me ef fec tive for the a pproved ne w animal drugproduct a nd ending on the date an application was initially submitt ed for such animal drugproduct unde r sec tion 512, and (i i) [Ap pr ov a l Pha se ] t

he pe ri od be g inn ing on the date the application was i nitiall y submitted

for the approve d animal drug product under subse ction (b) of section 512 and e nding on the date s u ch application was a pproved unde r such se ction. 35 U.S.C. § 156(g) (4) ( emphasis adde d). 3 The pa rties and the c ourt ag ree that in review ing this question of statutory interpre tation, the cour t must follow the two-step inquiry set forth in Chevron U.S.A. I nc. v. Natural Resource

s DefenseCouncil, Inc. , 467 U.S. 837, 842-43 (1984). Under Chevron , the cour t first inquires as6

to “whethe r Cong ress ha s directly spoken to the pre cise que stion at issue.” Id . at 842. “I f the int e nt o f C on g re ss i s c le ar, that is the e nd of the matte r; fo r t

he c ourt , a s w e ll a s th e a g e nc y , mu st g ive ef fec t to the unambiguously expressed intent of Cong ress.” Id . at 842-43. Sec ond, “[if] the court de termines [that] Congr ess has not direc tly addre ssed the pre cise que stion at issue, the court doe s not simpl y

impose its own construction on the statute . . . .” Id . at 843. “Rathe r, if the statut e is s ile nt o r a

mbi g uo us wi th r e sp e c t to the sp e c if ic iss ue , th e qu e sti on

fo r t he c ourt is whether the [FDA’s inter

pretation] is based on a pe rmissible construction of the statute.” Id
. If the FD A’s interpr etation “f ills a ga p or def ines a ter m in a way

that is reasona

ble in light of the leg islature' s reve aled de sign, [the cour t give s] t he F DA’s judg ment ‘controllingweig ht.’” NationsBank of N.C . v. Variable Annuity Life Ins. Co. , 513 U.S. 251, 257 (1995) (quoting Chevron, 467 U.S. at 844). A. Che v ro n St e p One The F DA dete rmined that the Appr oval Phase for Cy dectin beg an on January 13, 1998, the date on

wh ic h Wy e th s ub mitte d th e Ad min istra tiv e NA DA . T he F DAc on te nd s th a t th is interpre tation follows from the unambiguous lang uag e of 35 U .S.C. § 156(g) (4)( B) (ii). Specifica lly , the FD A emphasizes that the Appr oval Phase doe s not commence until “the application [i ]s i nitially

submitt ed . . . for

the appr oved animal dr

ug product unde r subsec tion (b) of sec tion 512 [ of the F ood, Drug , and Cosmetic Act ( “F DCA”).” Id. (empha sis added). Acc ordingto the FDA , an application does not constitute an “applica tion” within the meaningof
se c tio n 5 12 of

the F DC A, 21 U. S.C. § 3 60 b( b) , unle ss i t c on ta ins a ll o f t he inf or matio n, sampl e s,Se c tio n 5 12 (b ) o f t he F DC A p ro vid e s: 4 (1) Any person may

file with the Secr etar

y an application wi t h re s p ect to any intended use or

uses of a new a nimal drug
. Such person shall submit to the Secr etar y as a part of the application (A) f ull reports of investig ations which have been ma de to show whether

or not such drugis safe a nd eff ective f or use; (B ) a full l ist of the article s used as c omponents of such drug ; ( C) a full statement of the composition of such drug ; (D) a

full descr iption of the methods us ed i n , an d the fa cilities and controls used for , the manufa cture , proce ssing, a ndpackingof such dr

ug ; (E) such samples of such dr

ug and of the articles used as c omponents thereof , of any animal fee d fo r u s e i n or on which suc h drugis intended, and of the edible portions or products (be fore or af

ter slaug hter) of

animals to which such drug(direc tly or in or on ani mal feed ) i s i nt end ed t o b e adm in is ter ed, as t he S ecret ary may requ ir e; ( F) sp e c ime ns of

the la be lin g pr op os e d to be us e d f or su c h d ru g , o r i n c a se su c h d

ru g is intended f

o r u s e in an im a l f

e e d , p r o p o s e d la

b e li n g a p p r o p r iate f

o r s u c h u s e , and specimens of

the l abeling for the drug to be manufa cture d, packe d, or distributed by th e a p p l i c an t ; ( G ) a d e s c r i p t i o no f p r a c t i c a b l e m e th o d s f

o r d e t e r m i n i n g th e qu an t i ty, if any , of su c h dr

ug in or on fo od , and any su bs tanc e fo rm e d in or

on fo od , b e c a

us e of its us e ; and

(H ) t he pr op os e d to le ra

nc e or wi thd ra wa l pe ri od

or ot her us e re str ic tio ns fo r s uc h d

ru g if any tol e ra nc e or wi thd ra wa l pe ri od

or oth e r u se restric tions are require d in order to assure that the proposed use of such dr ug will be safe
. . . . 21 U.S.C. § 360b(b). 7 and sp e c ime ns that are re qu ir e d f or F DAa pp ro va l. See 21 U. S.C. § 3 60 b( b) ; se e als o 21 C.F .R.

4 § 5 1 4
. 1 ( b ) ( d e s c r i b i n g a

p p l i c a t i o na s c o n s i s t i n g o f a l l r e qu i r e d

t e c h n i c a l s e c t i o n s )
. A c c o r d i n g l y, the FD A contends that an “a pplication” is not “initially submitt ed” unde r the Phased Re view proce ss until t he F DA conf irms all technica l sections are complete a nd the applica

nt submit s an Administrative NADA. Wy eth counter s that the Approva l Phase corr esponds to the entire period of time that the FDAactua lly

spends per formingits subst antive re view of a n application, not just the amount of time require d to reviewan Administrative NAD A. Acc ording to Wy eth, this interpretation fo llo ws fr om t

he un ambi g uo us langua g e of 35 U. S.C. § 1 56 (g )( 4) (B )( ii) . Sp e c if ic a lly , Wy e th8

e mph a size s th a t th e Ap pr ov a l Ph a se do e s n ot c omm e nc e un til “ the a pp lic atio n [i]s ini tia lly submitted . . . for the a

pproved a nimal drug product unde r subsec tion (b) of sec tion 512 [ of the FDCA].” 35 U.S.C. § 156(g )(4) (B )(ii) (e mphasis added) . Acc ording to Wy eth, Cong ress ha s
e xpla ine d th a t an a

pp lic a tio n is initial ly submitted when a n applicant submits sufficient information to allow the F DA to comme nce its subst antive re view: [The term “initially

submi t t ed ”] i s used instead of the term “f iled” bec ause a

n application is often not conside red to be filed, even though ag ency revie w has be g un, until the ag ency

has dete rmined that no other infor mation is needed a

nd a dec ision on the application can be made. For purposes of de termining the re g ulatory revie w pe ri od and its c omp on e nts pe ri od s, an a pp lic a tio n fo r a g e nc y re vie w is c on sid e re d to be “initially

submitt ed” if

the applica

nt has m ad e a d eliberate ef fort to submit an ap p l ication containingall information nec essar y for a g ency

revie w to beg in. The Commi ttee re cog nizes that the ag ency rec eiving the application might decide it needs additional information or other chang es in the application. As longas the a pplication was c omplete enoug h so that the ag ency action could be commence d , it would be considere d to be “initially submitt ed.” H.R. Rep. No. 98-857, pt. 1, at 44 (1984) . Wy eth also points out that the reviewof an Ad min istrativ e NA DAdo e s n ot r e qu ir e the F DAto p e rf or m a su bs tanti ve re vie w at a ll b e c a us e
an a pp lic ant o nly

may su bmi t an A dmi nis tr a tiv e NA DAa ft e r t he F DAa lr e a dy

ha s a pp ro ve d a ll the te c hn ic a l se c tio ns . T hu s, a c c or din g to Wye th, the F DA ’s int e rp re tatio n e ff e c tiv e ly wo uld
rea d the word “ initially ” out of the statutory text there by

instit uting a

“filing ” re quirement rather tha n a n “ ini tia lly

su bmi tte d” re qu ir e me nt, wh ic h Wy e th c on te nd s is c on tr ary to C on g re ss’ s inte nt. Poi nti ngto t

he same Re po rt , th e F DAargue s th a t th e le g isl a tiv e his tor y su pp or ts i ts
rea ding that an application is not an “a pplication” unless all tec hnical sec tions are c omplete: F or purp os e s o f d e te rm ini ng the re g ulator y re vie w p e ri od

and its c omp on e nt p e ri od s, an application for ag ency revie w is consi d er ed to be “initially submitt ed” if

the ap p l i cant has made a

deliberate ef

fort to submit an application c o n ta i n i n g all information necessary for a g ency revie w to beg in.Wy e th s e e ks to a lla y any c on c e rn s th a t, u

nd e r i ts i nte rp re tatio n, ne arl y any fi lin g wo uld 5 trig g er the approva l proce ss by noting that the F DA may reje ct a de ficient tec hnical sec tion, (see F DA 00 00 04 ; F DA 00 00 19 ), and that on ly tho se pe ri od s d

ur ingwh ic h a

n a pp lic ant i s a c tin g wi th rea sonable dilig ence are included in a patent term extension, see35 U.S.C. § 156(c)(1)
. 9 H.R. Rep. No. 98-857, pt. 1, at 44 (1984) (empha sis added). The FDAasks the cour t to interpret this section as evidenc ing Cong ress’s intent that the submission of partial infor mation to an I NAD F ile, such as one technica l section, could not beg in the Approva l Phase bec ause the Approva l Phase ca

nnot beg in until an “application conta in[ s] all i nformation nec essar y for ag ency revie w to beg in.” Id . This argument notwithstanding, the F DA also c ontends that Wy e th’ s r e lia

nc e on H. R. R e p. No . 9 8- 85 7 is mis pla c e d b e c a us e the Ho us e Re po rt

wa s is su e d in 1984 and per

tains only to Traditional Review c onsideringthat Phased Review w as not institut ed until five y ear s later in 1989. A lt h o u g hth e p arti e s a g r e e th a t t h e Ap p r o v a l P h a s e c o mm e n c e s w h e n“ th e a p p li c a ti o n[i ]s initially submitt ed fo r t

he a pp ro ve d a nim a l dr ugpr od uc t un de r [2 1 U .S. C. § 36 0b (b )], ” 35 U. S.C. § 156(g )(4) (B )(ii), they

disag ree as to the prope r interpr etation of this statutory provision and emphasize diffe rent text therein in support of their positions: the FDA c ontends that there was no “application” until W y eth submitted its Admi nistrative NADA ; and Wy eth contends that the
a pp lic a tio n w a s “ ini tia lly

su bmi tte d” up on

its su bmi ssi on of the fi rs t te c hn ic a l se c tio n. B e c a us e 5 the cour t finds that both parties have advanc ed plausible re ading s of the statute at issue, the court ho lds that th e statut e is a

mbi g uo us . The c ourt beg ins by

looking to the plain text of the provision at issue — 35 U.S.C. § 156(g )(4) (B )(ii). See U

.S. Dep’ t of Tr easury v . Fabe , 5 08 U. S. 4 91 , 5 00 (1 99 3) ; Stewart v. Nat’l Shopmen Pe nsion Fund , 730 F.2d 1552, 1561 ( D.C. Cir. 1984). There , the cour t finds no clearWy e th a lso re lie s o n c e rt a in r e g ulatio ns in s up po rt of its c on te nti on s w ithre sp e c t to 6 Chevron step one. (Pl. Mot. Summ . J . [#32] , at 23-29 (c iting 21 C.F.R. §§ 60.22(f ) and 514.1(a) .) Wy eth does not explain, however , how FD A re g ulations that were promulg ated a fter the ena ctment of 35 U.S.C. § 156(g )(4) (B )(ii) should bea r on the c ourt’s interpr etation of that statute under Chevron step one. Ne verthe less, the cour t has examined these re g ulatory pr ov isi on s and

de te rm ine d th a t th e y , li ke the statut or y pr ov isi on s at is su e , a

re su ff ic ie ntl y ambig uous to allow the FD A’s interpr etation that the Appr oval Phase c ommences upon submissi on of an A dminist rative N ADA. The court re ache s this conclusion having g iven due consideration to the significa nt defe renc e that cour

ts must afford to an a g ency ’s interpre tation of 10 ind ic a tio n o f c on g re ssi on a l in te nt b e c a us e the statut e de fi ne s n e ith e r “ a pp lic a tio n” no r “ ini tia lly submitt ed.” L ooking to 21 U.S.C. § 360b(b), the court a cknowledg es the F DA’s position that this section sets forth the re quired “ part[s] of the a pplication,” but this section does not define “applica tion” nor does it speak to the issue of whe n an “a pplication” is “initially

submitt ed.” Indeed, the words “initially submitt ed” sug g est that something le ss than a complete or final
a pp lic a tio n ma

y be su ff ic ie nt t o tr ig g e r t

he Ap pr ov a l Ph a se . Y e t, t he statut e do e s n ot p la inl y state that it must be so. B e c a us e the c ourt

c ann ot d isc e rn

the me anin g of

the pr ov isi on

a t is su e fr om i ts p la in t e xt, the c ourt mus t lo ok

be y on d th e te xt to “ e xami ne the me anin g of c e rt a in w or ds or

phra se s in context and also ‘exhaust the traditional tools of statutory construction, includingexamining the statute’s leg islative history to shed new lig ht on cong ressional intent’[.]” Sierra Club v. E.P.A. , 5 5 1 F. 3 d 1 0 1 9 , 1 0 2 7 (D
. C
. C i r. 2 0 0 8 ) ( qu o t i n g Am. Banke rs Ass’n v. Nat’l Credit Union Admin., 271 F.3d 262, 267 ( D.C. Cir. 2001)). Consideringthe context and leg islative history of the statutory provision at issue, howeve r, provides little clar ity . As the par ties have shown, the court may rea d H.R. Rep. No. 98-857, pt. 1, at 44 (1984) to support either of the ir interpre tations. Ac c or din g ly , th e c ourt

ho lds that 35 U. S.C. § 1 56 (g )( 4) (B )( ii) is a mbi g uo us ba se d o n it s te xt,
c o n t e x t , a n d l e g i s l a t i v e h i s t o r

y. 6its own regulation. Cap ita l Ne two rk Sy s. , I nc . v . FCC , 28 F.3d 201, 206 ( D.C. Cir. 1994) (obser ving that the defe renc e af forde d to an ag ency ’s interpre tation of its own regulation may be g re a te r t ha n th e de fe re nc e a ff

or de d to an a g e nc y ’s int e rp re tatio n o f a statut e it i s e ntr

us te d to administer). Spe c if ic a lly , th e F DAc on te nd s th a t it s in te rp re tatio n is e nti tle d to de fe re nc e be c a us e 7 the FD A re asonably

balanc ed the c omplex policy considerations of patent term re storation and Phased Review. T he F DA conte nds that the purpose of Phased Review is to cr eate g reater eff iciencie s in the approva l proce ss for new drug s thereby

allowing them to enter the marke t fa ste r. Th e tr a de -o ff

, a c c or din g to t

he F DA , is that dr

ug s w hic h in

the Pha se d Re vie w p ro c e ss g ener ally rec eive a shorter patent term extension because the Approva l Phase for a n Administrative NADA is fa r shorter than the Appr oval Phase for a tra ditional NADA. The FDA argues that ac ceptingWy eth’s interpr etation would frustrate the policy balanc e by

allowing Pha se d Re vie w a

pp lic ants no t on ly

to b ri ngthe ir

dr ug s to mark e t f

a ste r b ut a lso to i nc re a se the ir pate nt t e rm

e xten sio n b y

a dis pr op or

tio na lly -l on g Ap pr ov a l Pe ri od . Wy e th d isc ounts the se policy objectives a

nd acc uses the F DA of suppor ting its interpre tation with non-exi stent dis tin c tio ns be tw e e n th e Tr a dit ion a l and Pha se d Re vie w p ro c e sse s. Th e c ourt c ann ot s us ta in Wy eth’s ef

forts to underc ut the FDA ’s policy arguments beca

use it finds that the FD A’s construction of 35 U .S.C. § 156(g) (4)( B) (ii) does not “f rustrate the policy

that Congr ess soug ht to implement.” Shays v. Fe d. Election Comm’n , 528 F.3d 914, 919 ( D.C. Cir. 2008) (quoting Cont’l Air L ines, Inc. v . Dep’ t of Tr ansp. , 843 F.2d 1444, 1453 ( D.C. Cir. 1988)). The F DA points out that it has consistently deter mined that the Approva l Phase beg ins 8 upon submissi on of the Administrative NA DA, and that such deter minations have produc ed simil arly short Approva l Phases: Neuter sol (34 day s); Anipryl (54 day s); I vomec ( 17 day s). (De fs.’ Mot. to Dismiss [ #22], at 8.) 11 B. Che v ro n St e p T wo Th e F DAc on te nd s th a t e ve n if the c ourt we re to f ind that 35 U. S.C. § 1 56 (g )( 4) (B )( ii) is
amb i g u o u s , th e c o urts h o u l d d e f e r t o th e F D A ’ s r e a s o n a

b l e i n t e r p r e t a t i o no f

th e s t a tu t e . In addition to reiterating its arguments with respec t to Chevron Step One, the F DA adva nces numerous policy

arguments, and it contends that its interpre tation refle cts long -standingprac tice

7

and pr e c e de nt. Wy e th a

rgue s th a t e ve n if

the c ourt fi nd s th a t § 1 56 (g )( 4) (B )( ii) is a mbi g uo us , 8 the cour t must find the FDA’ s interpre tation to be unrea sonable a nd thus unworthy

of def ere nce. In addition to reiterating its arguments with respec t to Chevron Ste p O ne , Wy e th a rgue s th a t it

isWy e th a lso c on te nd s th a t th e F DA ’s tr e a tme nt o f a nim a l dr ug s is inc on sis te nt w ithits 9 treatment of human drug s, which is contra ry to Congre ssional intent that they be tre ated sim ila rl y . T he F DAc ounte rs that th e re is n o me ri t to thi s a lle g a tio n b e c a us e Pha se d Re vie w i s not available f

or human drug s. The cour t ag ree s with the FDA
. 12 inc on sis te nt f

or the F DAto a dmi t it

is e ng a g ingin s ub sta

nti ve re vie w b y

iss uin g a Com ple te L etter while maintaining that the Approva l Phase has not y et begun. Such an interpr etation,
acc ordingto Wy eth, ef

fec tively car ves out the entire period of substantive r eview f rom the Approva l Phase and runs c ontrary to cong ressional intent to cre dit the entire substantive re view period towa

rd pate nt term restoration. The F DA re joins that W y eth’s interpr etation conf lates the 9 Approva l Phase with the TestingPhase. In particula r, the F DA points out that W y eth ca nnot de ny that w hil e it s ub mitte d a

te c hn ic a l se c tio n a s e arl y a s 1 99 5, Wy e th c on tin

ue d it s investigation and testing w ith respec t to other sections throug h 1998. Thus, acc ording to the F DA , Wy e th’ s inte rp re tatio n w ou ld h ave the c ourt de c lare that th e Te sti ngPha se e nd e d at a tim e when the bulk of

the re quisite testing still remained to be done
. Under Chevron step two, Wy eth bea rs the burde n of showingthat the FD A’s interpre tation is unreasona ble. See Swe et HomeChapter of Communiti es for a Great Oregon v

. Ba bb itt , 17 F.3d 1463, 1473 ( D.C. Cir. 1994), rev’d on other grounds , 515 U.S. 687 (1995). Wy eth has not met its burden he re be cause the cour t finds the FDA ’s ar guments to be more persua sive than those made by Wy eth. Indeed, the FDA ’s construc tion runs true to the text and define s “initially

submitt ed” in a

manner “that is rea sonable in lig ht of the leg islature’s r evea led desig n.” NationsBank , 513 U.S. at 257. Acc ording ly , the cour t cannot say

that the FD A’s interpre tation is based on an imper missibl e construc tion of the statute, nor c an the c ourt find that the FD A’s interpr etation violates the APA. See Che vron, 467 U.S. at 843; 5 U.S.C. § 706(2)(A).13 III . C ON CL USI ON For the fore g oing r easons, F DA’s motion to dismi ss or alternatively for summary jud g me nt [# 22 ] is G RA

NT ED and

Wy e th’ s c ro ss- mot ion

fo r s umm ary

jud g me nt [# 32 ] is DENI ED. An appr opriate or der a ccompa nies this Memorandum Opinion.

Henr y H. Kenne dy , J r. Un i t edS t at es Di s tri ct J u d ge