IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF DELAWARE ) ) ) ) ) ) ) ) ) ) ) ) )

CEPHALON, INC., Plaintiff, v. AGILA SPECIALTIES INC. f/k/a STRIDES, INC. and ONCO THERAPIES LIMITED, Defendants.

C.A. N . !!!!!!!!!!!

COMPLAINT Ce"#al n, In$. %&Ce"#al n' ( &Plaintiff') )(in*s t#is a$ti n f ( "atent inf(in*e+ent a*ainst Defendants A*ila S"e$ialties In$. f/k/a St(ides, In$. and On$ %$ lle$tivel, &On$ ' ( &Defendants'). -. T#is is an a$ti n ), Ce"#al n a*ainst On$ f ( inf(in*e+ent f .nited States T#e(a"ies Li+ited

Patent N . /,001,120 %&3120 "atent') and .nited States Patent N . /,045,-67 %&3-67 "atent'). T#is a$ti n a(ises 8t f On$ 3s filin* f an A))(eviated Ne9 D(8* A""li$ati n %&ANDA') seekin* a""( val ), t#e .nited States : d and D(8* Ad+inist(ati n %&:DA') t sell *ene(i$ ve(si ns f TREANDA;, Ce"#al n3s inn vative t(eat+ent f ( $#( ni$ l,+"# $,ti$ le8ke+ia and n n<H d*kin3s l,+"# +a, "(i ( t t#e e="i(ati n f t#e 3120 and 3-67 "atents. THE PARTIES Cephalon, Inc. 2. Plaintiff Ce"#al n, In$. is a $ (" (ati n "e(atin* and e=istin* 8nde( t#e la9s f (es R ad, :(a>e(, Penns,lvania -6411.

Dela9a(e, 9it# its "(in$i"al "la$e f )8siness at 0- M

Ce"#al n is en*a*ed in t#e )8siness

f (esea($#, devel "+ent, +an8fa$t8(e, and sale

inn vative "#a(+a$e8ti$al "( d8$ts t#( 8*# 8t t#e 9 (ld. Agila Specialtie Inc. an! Onco The"apie Li#ite! 4. ." n inf (+ati n and )elief, Defendant A*ila S"e$ialties In$. f/k/a St(ides, In$. is

a $ (" (ati n (*ani>ed and e=istin* 8nde( t#e la9s f Ne9 ?e(se,, 9it# its "(in$i"al "la$e f )8siness at 27- S 8t# Main St(eet, S8ite @4, La+)e(tville, Ne9 ?e(se, 7/147. 0. ." n inf (+ati n and )elief, Defendant On$ T#e(a"ies Li+ited is a $ (" (ati n

(*ani>ed and e=istin* 8nde( t#e la9s f India, 9it# its "(in$i"al "la$e f )8siness at St(ides H 8se, Ailka#alli, Aanne(*#atta R ad, Aan*al (e, Ba(nataka India 1577C5. 1. ." n inf (+ati n and )elief, ) t# A*ila S"e$ialties In$. f/k/a St(ides In$. and

On$ T#e(a"ies Li+ited s8)+itted, $ lla) (ated and/ ( a$ted in $ n$e(t in t#e "(e"a(ati n ( s8)+issi n f ANDA N . 270-70. $URISDICTION AND %ENUE S&'(ect Matte" $&"i !iction 5. C. T#is a$ti n f ( "atent inf(in*e+ent a(ises 8nde( 41 ..S.C. D 2C-. T#is C 8(t #as E8(isdi$ti n ve( t#e s8)Ee$t +atte( f t#is a$ti n "8(s8ant t 2/

..S.C. DD -44- and -44/%a), and t#e De$la(at (, ?8d*+ent A$t, 2/ ..S.C DD 227- and 2272. Pe" onal $&"i !iction O)e" De*en!ant /. ." n inf (+ati n and )elief, t#is C 8(t #as "e(s nal E8(isdi$ti n ve( A*ila

S"e$ialties In$. f/k/a St(ides, In$. and On$ T#e(a"ies Li+ited )e$a8se, a+ n* t#e( t#in*s, ) t# defendants +a(ket, dist(i)8te and/ ( sell *ene(i$ d(8*s t#( 8*# 8t t#e .nited States and 9it#in t#e State f Dela9a(e and t#e(ef (e "8(" sef8ll, avail t#e+selves f t#e "(ivile*e f $ nd8$tin* a$tivities 9it#in t#e State f Dela9a(e. Defendants #ave als $ ++itted, ( aided, a)etted,

$ nt(i)8ted t and/ ( "a(ti$i"ated in t#e $ ++issi n f, t#e t (ti 8s a$ti n f "atent inf(in*e+ent t#at #as led t f (eseea)le #a(+ and inE8(, t Ce"#al n, 9#i$# +an8fa$t8(es TREANDA;, f ( sale and 8se t#( 8*# 8t t#e .nited States, in$l8din* t#e State f Dela9a(e. 6. ." n inf (+ati n and )elief, Defendants "(evi 8sl, #ave )een s8ed in t#is

?8di$ial Dist(i$t, did n t $#allen*e t#is C 8(t3s e=e(ti n f "e(s nal E8(isdi$ti n ve( t#e+, and #ave availed t#e+selves f t#is f (8+ ), asse(tin* $ 8nte($lai+s f ( t#e "8(" se f liti*atin* a "atent inf(in*e+ent dis"8te. See, e.g., Cubist Pharm. Inc. v. Strides Inc. et al., C.A. N . -4< 7-5C6 %D. Del.)F Aventis Pharma S.A. et al. v. Strides, Inc. et al., -G--<$v<7--2- %D. Del.)F Senju Pharm. Co., Ltd. et al. v. Strides, Inc. et al., C.A. N . -4<77/1- %D. Del.). %en&e -7. Hen8e is "( "e( in t#is ?8di$ial Dist(i$t 8nde( 2/ ..S.C. DD -46- and -077%)). +AC,-ROUND The ./01 Patent --. T#e 3120 "atent, entitled &S lid : (+s f Aenda+8stine H,d( $#l (ide,' 9as

d8l, and la9f8ll, iss8ed n Ma, 2-, 27-4 t invent (s La8(ent D. C 8(v isie(, R )e(t E. M$Bean, Hans<? a$#i+ ?Ins$#, and He( niJ8e C 8(v isie(. -2. Ce"#al n. -4. 3120 "atent. -0. T#e 3120 "atent is listed in :DA "8)li$ati n &A""( ved D(8* P( d8$ts 9it# Ce"#al n is t#e s le 9ne( ), assi*n+ent f all (i*#ts, title and inte(est in t#e T#e na+ed invent (s f t#e 3120 "atent assi*ned t#ei( (i*#ts in t#e 3120 "atent t

T#e(a"e8ti$ EJ8ivalen$e Eval8ati ns,' $ ++ nl, (efe((ed t as &t#e O(an*e A k' %&O(an*e A k'), 9it# (es"e$t t TREANDA;.

-1.

T#e 3120 "atent 9ill e="i(e n Ma($# 25, 2726. A t(8e and a$$8(ate $ ", f t#e

3120 "atent is atta$#ed #e(et as E=#i)it A. The .234 Patent -5. T#e 3-67 "atent, entitled &Aenda+8stine P#a(+a$e8ti$al C +" siti ns,' 9as d8l,

and la9f8ll, iss8ed n Ma, C, 27-4 t invent (s ?as n Ed9a(d A(ittain and ? e C(ai* :(anklin. -C. Ce"#al n. -/. 3-67 "atent. -6. 27. T#e 3-67 "atent is listed in t#e O(an*e A k 9it# (es"e$t t TREANDA;. T#e 3-67 "atent 9ill e="i(e n O$t )e( 25, 2747. A t(8e and a$$8(ate $ ", f t#e Ce"#al n is t#e s le 9ne( ), assi*n+ent f all (i*#ts, title and inte(est in t#e T#e na+ed invent (s f t#e 3-67 "atent assi*ned t#ei( (i*#ts in t#e 3-67 "atent t

3-67 "atent is atta$#ed #e(et as E=#i)it A. The TREANDA5 D"&g P"o!&ct 2-. Ce"#al n (esea($#ed, devel "ed, a""lied f ( and )tained :DA a""( val t

+an8fa$t8(e, sell, "( + te and/ ( +a(ket )enda+8stine #,d( $#l (ide "( d8$ts kn 9n as TREANDA;. 22. Ce"#al n #as )een sellin*, "( + tin*, dist(i)8tin* and +a(ketin* TREANDA; in

t#e .nited States sin$e 277/. 24. TREANDA; is indi$ated t t(eat $#( ni$ l,+"# $,ti$ le8ke+ia and n n<

H d*kin3s l,+"# +a. 20. 171%a) Ce"#al n # lds Ne9 D(8* A""li$ati n N . 22206 and N . 22474 8nde( Se$ti n

f t#e :ede(al : d, D(8* and C s+eti$ A$t, 2- ..S.C. D 411%a), f ( +8lti"le

TREANDA; "( d8$ts 8sed f ( t(eatin* $#( ni$ l,+"# $,ti$ le8ke+ia and n n<H d*kin3s l,+"# +a. The Onco ANDA 21. On$ filed 9it# :DA an A))(eviated Ne9 D(8* A""li$ati n 8nde( 2- ..S.C.

D 411%E) seekin* a""( val t +an8fa$t8(e, 8se, ffe( f ( sale, sell in and i+" (t int t#e .nited States Aenda+8stine HCl f ( inEe$ti n, f ( int(aven 8s inf8si n %21 +* and -77 +*) %&On$ 3s Aenda+8stine P( d8$t') "(i ( t t#e e="i(ati n f t#e 3120 and 3-67 "atents . 25. 2C. :DA assi*ned t#e ANDA f ( On$ 3s Aenda+8stine P( d8$t t#e n8+)e( 270-70. On$ als filed 9it# :DA, "8(s8ant t 2- ..S.C. D 411%E)%2)%A)%iv), a $e(tifi$ati n

alle*in* t#at t#e $lai+s f t#e 3120 and 3-67 "atents a(e invalid, 8nenf ($ea)le and/ ( 9 8ld n t )e inf(in*ed ), t#e +an8fa$t8(e, 8se, i+" (tati n, sale ( ffe( f ( sale f On$ 3s Aenda+8stine P( d8$t %&On$ 3s Pa(a*(a"# IH Ce(tifi$ati n'). 2/. A, lette( dated N ve+)e( C, 27-4, On$ n tified Ce"#al n t#at it #ad filed +a(ket On$ 3s Aenda+8stine P( d8$t "(i ( t t#e

ANDA N . 270-70 seekin* a""( val t

e="i(ati n f t#e 3120 and 3-67 "atents %&On$ N ti$e Lette('). 26. On De$e+)e( 27, 27-4, "8(s8ant t an Offe( f C nfidential A$$ess, Ce"#al n

(e$eived " (ti ns f t#e ANDA filed ), On$ , and Ce"#al n (evie9ed t# se " (ti ns f t#e ANDA. 47. T#is A$ti n is )ein* $ ++en$ed )ef (e t#e e="i(ati n f f (t,<five da,s f( + t#e

date f (e$ei"t f t#e On$ N ti$e Lette(. COUNT I 6INFRIN-EMENT OF U.S. PATENT NO. 7,11/,/01 +8 ONCO9 4-. T#e alle*ati ns f t#e "( $eedin* "a(a*(a"#s -K47 a(e (ealle*ed and in$ (" (ated

#e(ein ), (efe(en$e.

42. 3120 "atent. 44.

T#e 8se f On$ 3s Aenda+8stine P( d8$t is $ ve(ed ), ne ( + (e $lai+s f t#e

T#e $ ++e($ial +an8fa$t8(e, 8se, ffe( f ( sale, sale, +a(ketin*, dist(i)8ti n

and/ ( i+" (tati n f On$ 3s Aenda+8stine P( d8$t 9 8ld inf(in*e ne ( + (e $lai+s f t#e 3120 "atent. 40. t .nde( 41 ..S.C. D 2C-%e)%2)%A), On$ 3s s8)+issi n t :DA f t#e On$ ANDA

)tain a""( val f ( On$ 3s Aenda+8stine P( d8$t 9it# a Pa(a*(a"# IH Ce(tifi$ati n (elated )ef (e t#e e="i(ati n f t#e 3120 "atent $ nstit8tes an a$t ffe( t sell, sale, f inf(in*e+ent, and if f On$ 3s

t#e(et

a""( ved, t#e $ ++e($ial +an8fa$t8(e, 8se,

( i+" (tati n

Aenda+8stine P( d8$t $ ntainin* )enda+8stine #,d( $#l (ide, 9 8ld inf(in*e ne ( + (e $lai+s f t#e 3120 "atent. 41. On$ 9as a9a(e f t#e 3120 "atent 9#en en*a*in* in t#ese kn 9in* and

"8(" sef8l a$tivities and 9as a9a(e t#at filin* t#e On$ ANDA 9it# On$ 3s Pa(a*(a"# IH Ce(tifi$ati n 9it# (es"e$t t t#e 3120 "atent $ nstit8ted an a$t f inf(in*e+ent f t#e 3120 "atent. 45. ." n inf (+ati n and )elief, On$ 3s Aenda+8stine P( d8$t $ ntains t#e sa+e

a$tive "#a(+a$e8ti$al in*(edient, )enda+8stine #,d( $#l (ide, as t#at 8sed in Ce"#al n3s TREANDA; "( d8$ts and $lai+ed in t#e 3120 "atent. 4C. ." n inf (+ati n and )elief, t#e +an8fa$t8(e f On$ 3s Aenda+8stine P( d8$t is

+ade 8sin* t#e s lid f (+ f )enda+8stine #,d( $#l (ide des$(i)ed in ne ( + (e $lai+s f t#e 3120 "atent. 4/. On$ 3s 8se f t#e s lid f (+ f )enda+8stine #,d( $#l (ide in t#e +an8fa$t8(e f

On$ 3s Aenda+8stine P( d8$t inf(in*es ne ( + (e $lai+s f t#e 3120 "atent.

46.

." n inf (+ati n and )elief, On$ "lans and intends t , and 9ill, inf(in*e t#e

3120 "atent i++ediatel, and i++inentl, 8" n a""( val f t#e On$ ANDA. 07. ." n inf (+ati n and )elief, On$ , 8nde( 41 ..S.C. D 2C-%)), a$ted in $ n$e(t,

a$tivel, s8"" (ted, "a(ti$i"ated in, en$ 8(a*ed, and/ ( ind8$ed t#e inf(in*e+ent f ne ( + (e $lai+s f t#e 3120 "atent. 0-. ." n inf (+ati n and )elief, On$ "lans and intends t , and 9ill, a$tivel, ind8$e

inf(in*e+ent f t#e 3120 "atent 9#en t#e On$ ANDA is a""( ved, and "lans and intends t , and 9ill, d s i++ediatel, and i++inentl, 8" n a""( val. 02. ." n inf (+ati n and )elief, On$ kn 9s t#at t#e s lid f (+ f )enda+8stine

#,d( $#l (ide 8sed t +an8fa$t8(e On$ 3s Aenda+8stine P( d8$t is es"e$iall, +ade ( ada"ted f ( 8se in inf(in*in* t#e 3120 "atent and t#at t#e s lid f (+ f )enda+8stine #,d( $#l (ide 8sed t +an8fa$t8(e On$ 3s Aenda+8stine P( d8$t is n t s8ita)le f ( s8)stantial n n<inf(in*in* 8ses. ." n inf (+ati n and )elief, On$ "lans and intends t , and 9ill, $ nt(i)8te t t#e inf(in*e+ent f t#e 3120 "atent i++ediatel, and i++inentl, 8" n a""( val f t#e On$ ANDA. 04. T#e f (e* in* a$ti ns ), On$ $ nstit8te and/ ( 9 8ld $ nstit8te inf(in*e+ent f

t#e 3120 "atent, a$tive ind8$e+ent f inf(in*e+ent f t#e 3120 "atent and/ ( $ nt(i)8ti n t t#e inf(in*e+ent ), t#e(s f t#e 3120 "atent. 00. ." n inf (+ati n and )elief, On$ a$ted 9it# 8t a (eas na)le )asis f ( )elievin*

t#at it 9 8ld n t )e lia)le f ( inf(in*in* t#e 3120 "atent, a$tivel, ind8$in* inf(in*e+ent f t#e 3120 "atent and/ ( $ nt(i)8tin* t t#e inf(in*e+ent ), t#e(s f t#e 3120 "atent. 01. Ce"#al n 9ill )e s8)stantiall, and i((e"a(a)l, #a(+ed ), On$ 3s inf(in*in*

a$tivities 8nless t#e C 8(t enE ins t# se a$tivities. Ce"#al n 9ill #ave n adeJ8ate (e+ed, at

la9 if On$ is n t enE ined f( + t#e $ ++e($ial +an8fa$t8(e, 8se, ffe( t sell, sale in and i+" (tati n int t#e .nited States f On$ 3s Aenda+8stine P( d8$t. 05. On$ 3s a$tivities (ende( t#is $ase an e=$e"ti nal ne, and Ce"#al n is entitled t

an a9a(d f t#ei( (eas na)le att (ne, fees 8nde( 41 ..S.C. D 2/1. COUNT II 6DECLARATOR8 $UD-MENT OF INFRIN-MENT OF U.S. PATENT NO. 7,11/,/01 +8 ONCO9 0C. T#e alle*ati ns f t#e "( $eedin* "a(a*(a"#s -K05 a(e (ealle*ed and in$ (" (ated

#e(ein ), (efe(en$e. 0/. ." n inf (+ati n and )elief, On$ "lans t )e*in +an8fa$t8(in*, +a(ketin*, n afte( :DA a""( val

sellin*, ffe(in* t sell and/ ( i+" (tin* On$ 3s Aenda+8stine P( d8$t s f t#e On$ ANDA. 06.

S8$# $ nd8$t 9ill $ nstit8te di(e$t inf(in*e+ent f ne ( + (e $lai+s n t#e

3120 "atent 8nde( 41 ..S.C. D 2C-%a), ind8$e+ent f inf(in*e+ent f t#e 3120 "atent 8nde( 41 ..S.C. D 2C-%)), and $ nt(i)8t (, inf(in*e+ent 8nde( 41 ..S.C. D 2C-%$). 17. Defendants3 inf(in*in* "atent a$tivit, $ +"lained f #e(ein is i++inent and 9ill

)e*in f ll 9in* :DA a""( val f t#e On$ ANDA. 1-. As a (es8lt f t#e f (e* in* fa$ts, t#e(e is a (eal, s8)stantial, and $ ntin8in*

E8sti$ia)le $ nt( ve(s, )et9een Ce"#al n and Defendants as t lia)ilit, f ( t#e inf(in*e+ent f t#e 3120 "atent. Defendants3 a$ti ns #ave $(eated in Ce"#al n a (eas na)le a""(e#ensi n f i((e"a(a)le #a(+ and l ss (es8ltin* f( + Defendants3 t#(eatened i++inent a$ti ns. 12. "atent. ." n inf (+ati n and )elief, On$ 9ill kn 9in*l, and 9illf8ll, inf(in*e t#e 3120

14. 3120 "atent.

Ce"#al n 9ill )e i((e"a(a)l, #a(+ed if On$ is n t enE ined f( + inf(in*in* t#e

COUNT III 6INFRIN-EMENT OF U.S. PATENT NO. 7,1:;,234 +8 ONCO9 10. T#e alle*ati ns f t#e "( $eedin* "a(a*(a"#s -K14 a(e (ealle*ed and in$ (" (ated

#e(ein ), (efe(en$e. 11. 3-67 "atent. 15. T#e $ ++e($ial +an8fa$t8(e, 8se, ffe( f ( sale, sale, +a(ketin*, dist(i)8ti n T#e 8se f On$ 3s Aenda+8stine P( d8$t is $ ve(ed ), ne ( + (e $lai+s f t#e

and/ ( i+" (tati n f On$ 3s Aenda+8stine P( d8$t 9 8ld inf(in*e ne ( + (e $lai+s f t#e 3-67 "atent. 1C. t .nde( 41 ..S.C. D 2C-%e)%2)%A), On$ 3s s8)+issi n t :DA f t#e On$ ANDA

)tain a""( val f ( On$ 3s Aenda+8stine P( d8$t 9it# a Pa(a*(a"# IH Ce(tifi$ati n (elated )ef (e t#e e="i(ati n f t#e 3-67 "atent $ nstit8tes an a$t ffe( t sell, sale, f inf(in*e+ent, and if f On$ 3s

t#e(et

a""( ved, t#e $ ++e($ial +an8fa$t8(e, 8se,

( i+" (tati n

Aenda+8stine P( d8$t $ ntainin* )enda+8stine #,d( $#l (ide, 9 8ld inf(in*e ne ( + (e $lai+s f t#e 3-67 "atent. 1/. On$ 9as a9a(e f t#e 3-67 "atent 9#en en*a*in* in t#ese kn 9in* and

"8(" sef8l a$tivities and 9as a9a(e t#at filin* t#e On$ ANDA 9it# On$ 3s Pa(a*(a"# IH Ce(tifi$ati n 9it# (es"e$t t t#e 3-67 "atent $ nstit8ted an a$t f inf(in*e+ent f t#e 3-67 "atent. 16. ." n inf (+ati n and )elief, On$ 3s Aenda+8stine P( d8$t $ ntains t#e sa+e

a$tive "#a(+a$e8ti$al in*(edient, )enda+8stine #,d( $#l (ide, as t#at 8sed in Ce"#al n3s TREANDA; "( d8$ts and $lai+ed in t#e 3-67 "atent.

57.

." n inf (+ati n and )elief, t#e +an8fa$t8(e f On$ 3s Aenda+8stine P( d8$t is

+ade ), l, "#ili>in* t#e )enda+8stine #,d( $#l (ide "#a(+a$e8ti$al $ +" siti ns des$(i)ed in ne ( + (e $lai+s f t#e 3-67 "atent. 5-. On$ 3s 8se f a l, "#ili>ed )enda+8stine #,d( $#l (ide "#a(+a$e8ti$al

$ +" siti n in t#e +an8fa$t8(e f On$ 3s Aenda+8stine P( d8$t inf(in*es ne ( + (e $lai+s f t#e 3-67 "atent. 52. ." n inf (+ati n and )elief, On$ "lans and intends t , and 9ill, inf(in*e t#e

3-67 "atent i++ediatel, and i++inentl, 8" n a""( val f t#e On$ ANDA. 54. ." n inf (+ati n and )elief, On$ , 8nde( 41 ..S.C. D 2C-%)), a$ted in $ n$e(t,

a$tivel, s8"" (ted, "a(ti$i"ated in, en$ 8(a*ed, and/ ( ind8$ed t#e inf(in*e+ent f ne ( + (e $lai+s f t#e 3-67 "atent. 50. ." n inf (+ati n and )elief, On$ "lans and intends t , and 9ill, a$tivel, ind8$e

inf(in*e+ent f t#e 3-67 "atent 9#en t#e On$ ANDA is a""( ved, and "lans and intends t , and 9ill, d s i++ediatel, and i++inentl, 8" n a""( val. 51. ." n inf (+ati n and )elief, On$ kn 9s t#at t#e l, "#ili>ed )enda+8stine

#,d( $#l (ide "#a(+a$e8ti$al $ +" siti n 8sed t +an8fa$t8(e On$ 3s Aenda+8stine P( d8$t is es"e$iall, +ade ( ada"ted f ( 8se in inf(in*in* t#e 3-67 "atent and t#at t#e )enda+8stine #,d( $#l (ide "#a(+a$e8ti$al $ +" siti n 8sed t +an8fa$t8(e On$ 3s Aenda+8stine P( d8$t is n t s8ita)le f ( s8)stantial n n<inf(in*in* 8ses. ." n inf (+ati n and )elief, On$ "lans and intends t , and 9ill, $ nt(i)8te t t#e inf(in*e+ent f t#e 3-67 "atent i++ediatel, and

i++inentl, 8" n a""( val f t#e On$ ANDA.

-7

55.

T#e f (e* in* a$ti ns ), On$ $ nstit8te and/ ( 9 8ld $ nstit8te inf(in*e+ent f

t#e 3-67 "atent, a$tive ind8$e+ent f inf(in*e+ent f t#e 3-67 "atent and/ ( $ nt(i)8ti n t t#e inf(in*e+ent ), t#e(s f t#e 3-67 "atent. 5C. ." n inf (+ati n and )elief, On$ a$ted 9it# 8t a (eas na)le )asis f ( )elievin*

t#at it 9 8ld n t )e lia)le f ( inf(in*in* t#e 3-67 "atent, a$tivel, ind8$in* inf(in*e+ent f t#e 3-67 "atent and/ ( $ nt(i)8tin* t t#e inf(in*e+ent ), t#e(s f t#e 3-67 "atent. 5/. Ce"#al n 9ill )e s8)stantiall, and i((e"a(a)l, #a(+ed ), On$ 3s inf(in*in*

a$tivities 8nless t#e C 8(t enE ins t# se a$tivities. Ce"#al n 9ill #ave n adeJ8ate (e+ed, at la9 if On$ is n t enE ined f( + t#e $ ++e($ial +an8fa$t8(e, 8se, ffe( t sell, sale in and i+" (tati n int t#e .nited States f On$ 3s Aenda+8stine P( d8$t. 56. On$ 3s a$tivities (ende( t#is $ase an e=$e"ti nal ne, and Ce"#al n is entitled t

an a9a(d f t#ei( (eas na)le att (ne, fees 8nde( 41 ..S.C. D 2/1. COUNT I% 6DECLARATOR8 $UD-MENT OF INFRIN-MENT OF U.S. PATENT NO. 7,1:;,234 +8 ONCO9 C7. T#e alle*ati ns f t#e "( $eedin* "a(a*(a"#s -K56 a(e (ealle*ed and in$ (" (ated

#e(ein ), (efe(en$e. C-. ." n inf (+ati n and )elief, On$ "lans t )e*in +an8fa$t8(in*, +a(ketin*, n afte( :DA a""( val

sellin*, ffe(in* t sell and/ ( i+" (tin* On$ 3s Aenda+8stine P( d8$t s f t#e On$ ANDA. C2.

S8$# $ nd8$t 9ill $ nstit8te di(e$t inf(in*e+ent f ne ( + (e $lai+s n t#e

3-67 "atent 8nde( 41 ..S.C. D 2C-%a), ind8$e+ent f inf(in*e+ent f t#e 3-67 "atent 8nde( 41 ..S.C. D 2C-%)), and $ nt(i)8t (, inf(in*e+ent 8nde( 41 ..S.C. D 2C-%$).

--

C4.

Defendants3 inf(in*in* "atent a$tivit, $ +"lained f #e(ein is i++inent and 9ill

)e*in f ll 9in* :DA a""( val f t#e On$ ANDA. C0. As a (es8lt f t#e f (e* in* fa$ts, t#e(e is a (eal, s8)stantial, and $ ntin8in*

E8sti$ia)le $ nt( ve(s, )et9een Ce"#al n and Defendants as t lia)ilit, f ( t#e inf(in*e+ent f t#e 3-67 "atent. Defendants3 a$ti ns #ave $(eated in Ce"#al n a (eas na)le a""(e#ensi n f i((e"a(a)le #a(+ and l ss (es8ltin* f( + Defendants3 t#(eatened i++inent a$ti ns. C1. "atent. C5. 3-67 "atent. PRA8ER FOR RELIEF LHERE:ORE, Ce"#al n (es"e$tf8ll, (eJ8est t#e f ll 9in* (eliefG a. ). a E8d*+ent t#at t#e 3120 and 3-67 "atents a(e valid and enf ($ea)leF a E8d*+ent t#at On$ 3s s8)+issi n f t#e On$ ANDA N . 270-70, 9as an a$t f Ce"#al n 9ill )e i((e"a(a)l, #a(+ed if On$ is n t enE ined f( + inf(in*in* t#e ." n inf (+ati n and )elief, On$ 9ill kn 9in*l, and 9illf8ll, inf(in*e t#e 3-67

inf(in*e+ent f ne ( + (e $lai+s f t#e 3120 and 3-67 "atents and t#at t#e +akin*, 8sin*, ffe(in* t sell, sellin*, +a(ketin*, dist(i)8tin*, ( i+" (tin* f On$ 3s Aenda+8stine P( d8$t "(i ( t t#e e="i(ati n f t#e 3120 and 3-67 "atents 9ill inf(in*e, a$tivel, ind8$e inf(in*e+ent and/ ( $ nt(i)8te t t#e inf(in*e+ent f ne ( + (e $lai+s f t#e 3120 and 3-67 "atentsF $. an O(de( "8(s8ant t 41 ..S.C. D 2C-%e)%0)%A) "( vidin* t#at t#e effe$tive date f

an, :DA a""( val f t#e On$ ANDA N . 270-70 ( an, "( d8$t ( $ +" 8nd t#e 8se f 9#i$# inf(in*es t#e 3120 ( 3-67 "atent, s#all )e a date t#at is n t ea(lie( t#an t#e e="i(ati n f t#e 3120 ( 3-67 "atentF

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d.

an O(de( "8(s8ant t 41 ..S.C. D 2C-%e)%0)%A) "e(+anentl, enE inin* On$ and

all "e(s ns a$tin* in $ n$e(t 9it# On$ f( + $ ++e($iall, +an8fa$t8(in*, 8sin*, ffe(in* f ( sale, sellin*, +a(ketin*, dist(i)8tin*, ( i+" (tin* On$ 3s Aenda+8stine P( d8$t, ( an, "( d8$t ( $ +" 8nd t#e 8se f 9#i$# inf(in*es t#e 3120 ( 3-67 "atent 8ntil, ( ind8$in* ( $ nt(i)8tin* t t#e inf(in*e+ent f t#e 3120 ( 3-67 "atent afte( t#e e="i(ati n f t#e 3120 ( 3-67 "atentF e. an O(de( "8(s8ant t 41 ..S.C. D 2/4 "e(+anentl, enE inin* On$ and all "e(s ns

a$tin* in $ n$e(t 9it# On$ f( + $ ++e($iall, +an8fa$t8(in*, 8sin*, ffe(in* f ( sale, sellin*, +a(ketin*, dist(i)8tin*, ( i+" (tin* On$ 3s Aenda+8stine P( d8$t, ( an, "( d8$t (

$ +" 8nd t#e 8se f 9#i$# inf(in*es t#e 3120 ( 3-67 "atent 8ntil, ( ind8$in* ( $ nt(i)8tin* t t#e inf(in*e+ent f t#e 3120 ( 3-67 "atent afte( t#e e="i(ati n f t#e 3120 ( 3-67 "atentF f. seekin*, an O(de( enE inin* On$ )tainin*, and all "e(s ns a$tin* in $ n$e(t 9it# On$ f t#e On$ f( +

( +aintainin* a""( val

ANDA N . 270-70 )ef (e t#e

e="i(ati n f t#e 3120 and 3-67 "atentsF *. an a9a(d f Ce"#al n3s da+a*es ( t#e( + neta(, (elief t $ +"ensate

Ce"#al n if On$ en*a*es in t#e $ ++e($ial +an8fa$t8(e, 8se, ffe( t sell, sale ( +a(ketin* ( dist(i)8ti n in, ( i+" (tati n int t#e .nited States f On$ 3s Aenda+8stine P( d8$t, ( an, "( d8$t ( $ +" 8nd t#e 8se f 9#i$# inf(in*es t#e 3120 ( 3-67 "atent, ( t#e ind8$e+ent ( $ nt(i)8ti n f t#e f (e* in*, "(i ( t t#e e="i(ati n f t#e 3120 ( 3-67 "atent in a$$ (dan$e 9it# 41 ..S.C. D 2C-%e)%0)%C)F #. a E8d*+ent t#at t#is is an e=$e"ti nal $ase and a9a(din* Ce"#al n its att (ne,s3

fees 8nde( 41 ..S.C. D 2/1F i. an a9a(d f Ce"#al n3s (eas na)le $ sts and e="enses in t#is a$ti nF and

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an a9a(d f an, f8(t#e( and additi nal (elief t Ce"#al n as t#is C 8(t dee+s E8st

De$e+)e( 27, 27-4 O: CO.NSELG David M. Has#+all GOODLIN PROCTER LLP T#e Ne9 M (k Ti+es A8ildin* 527 Ei*#t# Aven8e Ne9 M (k, NM -77-/<-071 %2-2) /-4<//77 d#as#+allN* d9in"( $te(.$ + Da(,l L. Liesen E+il, L. Ra"alin Ni$# las B. Mit( k stas GOODLIN PROCTER LLP E=$#an*e Pla$e A st n, MA 72-76 %5-C) 1C7<-777 d9iesenN* d9in"( $te(.$ + e(a"alin N* d9in"( $te(.$ + n+it( k stasN* d9in"( $te(.$ +

AAMARD, P.A. /s/ Stephen B. Brauerman Ri$#a(d D. Bi(k %(k7622) Ste"#en A. A(a8e(+an %s)0612) Hanessa R. Ti(adentes %vt146/) Sa(a E. A8ssie(e %s)1C21) 222 Dela9a(e Aven8e, S8ite 677 Lil+in*t n, DE -6/7%472) 511<1777 (ki(kN)a,a(dla9.$ + s)(a8e(+anN)a,a(dla9.$ + vti(adentesN)a,a(dla9.$ + s)8ssie(eN)a,a(dla9.$ + Attorneys or Plainti Cephalon, Inc.

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