IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF DELAWARE ) ) ) ) ) ) ) ) ) ) COMPLAINT Cephalon, Inc. (Cephalon or Plain i!!

) "rin#$ hi$ ac ion !or pa en in!rin#e%en a#ain$ De!en&an San&o' Inc. (San&o' or De!en&an ). (. )hi$ i$ an ac ion "* Cephalon a#ain$ San&o' !or in!rin#e%en o! +ni e& S a e$

CEPHALON, INC., Plaintiff, v. SANDOZ INC., Defendant.

C.A. No. ___________

Pa en No. ,,--.,./- (0./- pa en ) an& +ni e& S a e$ Pa en No. ,,-12,(34 (0(34 pa en ). )hi$ ac ion ari$e$ o5 o! San&o'0$ !ilin# o! an A""revia e& Ne6 Dr5# Applica ion (ANDA) $ee7in# approval "* he +ni e& S a e$ 8oo& an& Dr5# A&%ini$ ra ion (8DA) o $ell #eneric ver$ion$ o! )9EANDA:, Cephalon0$ innova ive rea %en !or chronic l*%phoc* ic le57e%ia an& non;Ho&#7in0$ l*%pho%a, prior o he e<pira ion o! he 0./- an& 0(34 pa en $. THE PARTIES Cephalon, Inc. /. Plain i!! Cephalon, Inc. i$ a corpora ion opera in# an& e<i$ in# 5n&er he la6$ o!

Dela6are, 6i h i $ principal place o! "5$ine$$ a -( =oore$ 9oa&, 8ra'er, Penn$*lvania (31... Cephalon i$ en#a#e& in he "5$ine$$ o! re$earch, &evelop%en , %an5!ac 5re, an& $ale o! innova ive phar%ace5 ical pro&5c $ hro5#ho5 he 6orl&.

Sandoz Inc. 1. +pon in!or%a ion an& "elie!, De!en&an San&o' i$ a corpora ion or#ani'e& an&

e<i$ in# 5n&er he la6$ o! he S a e o! Colora&o, 6i h i $ principal place o! "5$ine$$ a .42 Carne#ie Cen er, S5i e -44, Prince on, Ne6 >er$e* 4,.-4. San&o' %a* "e $erve& 6i h proce$$ 5n&er he Dela6are Lon# Ar% S a 5 e, (4 Del. C. ? 1(4-. JURISDICTION AND ENUE S!"#ec$ Ma$$e% J!%&'d&c$&on -. .. )hi$ ac ion !or pa en in!rin#e%en ari$e$ 5n&er 1. +.S.C. ? /@(. )hi$ Co5r ha$ A5ri$&ic ion over he $5"Aec %a er o! hi$ ac ion p5r$5an o /,

+.S.C. ?? (11( an& (11,(a), an& he Declara or* >5&#%en Ac , /, +.S.C ?? //4( an& //4/. Pe%'onal J!%&'d&c$&on O(e% Sandoz 2. +pon in!or%a ion an& "elie!, hi$ Co5r ha$ per$onal A5ri$&ic ion over San&o' (() con&5c $ "5$ine$$ in hi$ >5&icial Di$ ric an& (/) ha$ en#a#e& in

"eca5$e San&o'B

con in5o5$ an& $*$ e%a ic con ac $ 6i h Dela6are an&Cor p5rpo$e!5ll* availe& i $el! o! hi$ !or5% "*, a%on# o her hin#$, %a7in#, %ar7e in#, $hippin#, 5$in#, o!!erin# o $ell or $ellin#, or ca5$in# o her$ o 5$e, o!!er o $ell, or $ell, San&o' phar%ace5 ical pro&5c $ in hi$ >5&icial Di$ ric , an& &erivin# $5"$ an ial reven5e !ro% $5ch ac ivi ie$. San&o' ha$ al$o co%%i e&, or ai&e&, a"e e&, con ri"5 e& o an&Cor par icipa e& in he co%%i$$ion o!, he or io5$ ac ion o! pa en in!rin#e%en ha ha$ le& o !ore$eea"le har% an& inA5r* o Cephalon, 6hich %an5!ac 5re$ )9EANDA:, !or $ale an& 5$e hro5#ho5 he +ni e& S a e$, incl5&in# he S a e o! Dela6are. 85r her, 5pon in!or%a ion an& "elie!, San&o' i$ re#i$ ere& 6i h he Dela6are Doar& o! Phar%ac* a$ a Di$ ri"5 orC=an5!ac 5rer an& Phar%ac*;Ehole$ale o! &r5# pro&5c $.

@.

+pon in!or%a ion an& "elie!, hi$ Co5r al$o ha$ per$onal A5ri$&ic ion over San&o'

"eca5$e San&o' previo5$l* ha$ availe& i $el! o! hi$ !or5% !or he p5rpo$e o! li i#a in# i $ pa en in!rin#e%en &i$p5 e$. See, e.g., Sandoz In c. v Pfizer Inc., C.A. No. 43;/-.@ (D. Del.).

A&&i ionall*, San&o' previo5$l* ha$ "een $5e& in hi$ >5&icial Di$ ric , &i& no challen#e hi$ Co5r 0$ e<er ion o! per$onal A5ri$&ic ion over i , an& availe& i $el! o! hi$ !or5% "* a$$er in# co5n erclai%$ !or he p5rpo$e o! li i#a in# a pa en in!rin#e%en &i$p5 e. See Genzyme

Corporation et al v. Sandoz Inc., C.A. No. (1;4(.4@ (D. Del)F UCB Inc. et al v. Sandoz Inc., C.A. No. (1;4(/(2 (D. Del). en!e ,. Gen5e i$ proper in hi$ >5&icial Di$ ric 5n&er /, +.S.C. ?? (13( an& (-44("). )AC*+ROUND The ,-./ Pa$en$ 3. )he 0./- pa en , en i le& Soli& 8or%$ o! Den&a%5$ ine H*&rochlori&e, 6a$

&5l* an& la6!5ll* i$$5e& on =a* /(, /4(1 o inven or$ La5ren D. Co5rvoi$ier, 9o"er E. =cHean, Han$;>oachi% >In$ch, an& GeroniJ5e Co5rvoi$ier. (4. Cephalon. ((. 0./- pa en . (/. )he 0./- pa en i$ li$ e& in 8DA p5"lica ion Approve& Dr5# Pro&5c $ 6i h Cephalon i$ he $ole o6ner "* a$$i#n%en o! all ri#h $, i le an& in ere$ in he )he na%e& inven or$ o! he 0./- pa en a$$i#ne& heir ri#h $ in he 0./- pa en o

)herape5 ic EJ5ivalence Eval5a ion$, co%%onl* re!erre& o a$ he Oran#e Doo7 (Oran#e Doo7) 6i h re$pec o )9EANDA:.

(1.

)he 0./- pa en 6ill e<pire on =arch /2, /4/3. A r5e an& acc5ra e cop* o! he

0./- pa en i$ a ache& here o a$ E<hi"i A. The ,012 Pa$en$ (-. )he 0(34 pa en , en i le& Den&a%5$ ine Phar%ace5 ical Co%po$i ion$, 6a$ &5l*

an& la6!5ll* i$$5e& on =a* @, /4(1 o inven or$ >a$on E&6ar& Dri ain an& >oe Crai# 8ran7lin. (.. Cephalon. (2. 0(34 pa en . (@. (,. )he 0(34 pa en i$ li$ e& in he Oran#e Doo7 6i h re$pec o )9EANDA:. )he 0(34 pa en 6ill e<pire on Oc o"er /2, /414. A r5e an& acc5ra e cop* o! he Cephalon i$ he $ole o6ner "* a$$i#n%en o! all ri#h $, i le an& in ere$ in he )he na%e& inven or$ o! he 0(34 pa en a$$i#ne& heir ri#h $ in he 0(34 pa en o

0(34 pa en i$ a ache& here o a$ E<hi"i D. The TREANDA3 D%!4 P%od!c$ (3. Cephalon re$earche&, &evelope&, applie& !or an& o" aine& 8DA approval o

%an5!ac 5re, $ell, pro%o e an&Cor %ar7e "en&a%5$ ine h*&rochlori&e pro&5c $ 7no6n a$ )9EANDA:. /4. Cephalon ha$ "een $ellin#, pro%o in#, &i$ ri"5 in# an& %ar7e in# )9EANDA: in

he +ni e& S a e$ $ince /44,. /(. )9EANDA: i$ in&ica e& o rea chronic l*%phoc* ic le57e%ia an& non;

Ho&#7in0$ l*%pho%a. //. Cephalon hol&$ Ne6 Dr5# Applica ion No. ///-3 an& No. //141 5n&er Sec ion

.4.(a) o! he 8e&eral 8oo&, Dr5# an& Co$%e ic Ac , /( +.S.C. ? 1..(a), !or %5l iple

)9EANDA: pro&5c $ 5$e& !or rea in# chronic l*%phoc* ic le57e%ia an& non;Ho&#7in0$ l*%pho%a. The Sandoz ANDA /1. San&o' !ile& 6i h 8DA an A""revia e& Ne6 Dr5# Applica ion 5n&er /( +.S.C.

? 1..(A) $ee7in# approval o %an5!ac 5re, 5$e, o!!er !or $ale, $ell in an& i%por in o he +ni e& S a e$ a "en&a%5$ ine h*&rochlori&e po6&er !or IG (in!5$ion), /. %#Cvial an& (44 %#Cvial (San&o'0$ Den&a%5$ ine Pro&5c ) prior o he e<pira ion o! he 0./- an& 0(34 pa en $. /-. /4-,.4. /.. San&o' al$o !ile& 6i h 8DA, p5r$5an o /( +.S.C. ? 1..(A)(/)(D)(iv), a 8DA a$$i#ne& he ANDA !or San&o'0$ Den&a%5$ ine Pro&5c he n5%"er

cer i!ica ion alle#in# ha

he clai%$ o! he 0./- an& 0(34 pa en $ are invali&, 5nen!orcea"le

an&Cor 6o5l& no "e in!rin#e& "* he %an5!ac 5re, 5$e, i%por a ion, $ale or o!!er !or $ale o! San&o'0$ Den&a%5$ ine Pro&5c (San&o'0$ Para#raph IG Cer i!ica ion). /2. D* le er &a e& Nove%"er (3, /4(1, San&o' no i!ie& Cephalon ha i ha& !ile&

ANDA No. /4-,.4 $ee7in# approval o %ar7e San&o'0$ Den&a%5$ ine Pro&5c prior o he e<pira ion o! he 0./- an&0(34 pa en $ (San&o' No ice Le er). /@. On Dece%"er /1, /4(1, Cephalon an& San&o' a#ree& o an O!!er o! Con!i&en ial

Acce$$. Ho6ever, San&o' !aile& o pro&5ce an* por ion$ o! he ANDA !ile& "* San&o' "e!ore he !ilin# o! hi$ Co%plain . /,. )hi$ Ac ion i$ "ein# co%%ence& "e!ore he e<pira ion o! !or *;!ive &a*$ !ro% he

&a e o! receip o! he San&o' No ice Le er.

COUNT I FOR INFRIN+EMENT OF U.S. PATENT NO. 5,//-,-./ )6 SANDO7 /3. )he alle#a ion$ o! he procee&in# para#raph$ (K/, are realle#e& an& incorpora e&

herein "* re!erence. 14. )he 5$e o! San&o'0$ Den&a%5$ ine Pro&5c i$ covere& "* one or %ore clai%$ o!

he 0./- pa en . 1(. )he co%%ercial %an5!ac 5re, 5$e, o!!er !or $ale, $ale, %ar7e in#, &i$ ri"5 ion

an&Cor i%por a ion o! San&o'0$ Den&a%5$ ine Pro&5c 6o5l& in!rin#e one or %ore clai%$ o! he 0./- pa en . 1/. +n&er 1. +.S.C. ? /@((e)(/)(A), San&o'0$ $5"%i$$ion o 8DA o! he San&o'

ANDA o o" ain approval !or San&o'0$ Den&a%5$ ine Pro&5c 6i h a Para#raph IG Cer i!ica ion rela e& here o "e!ore he e<pira ion o! he 0./- pa en con$ i 5 e$ an ac o! in!rin#e%en , an& i! approve&, he co%%ercial %an5!ac 5re, 5$e, o!!er o $ell, $ale, or i%por a ion o! San&o'0$ Den&a%5$ ine Pro&5c con ainin# "en&a%5$ ine h*&rochlori&e, 6o5l& in!rin#e one or %ore clai%$ o! he 0./- pa en . 11. San&o' 6a$ a6are o! he 0./- pa en 6hen en#a#in# in he$e 7no6in# an&

p5rpo$e!5l ac ivi ie$ an& 6a$ a6are ha !ilin# he San&o' ANDA 6i h San&o'0$ Para#raph IG Cer i!ica ion 6i h re$pec o he 0./- pa en con$ i 5 e& an ac o! in!rin#e%en o! he 0./- pa en . 1-. +pon in!or%a ion an& "elie!, San&o'0$ Den&a%5$ ine Pro&5c con ain$ he $a%e

ac ive phar%ace5 ical in#re&ien , "en&a%5$ ine h*&rochlori&e, a$ ha 5$e& in Cephalon0$ )9EANDA: pro&5c $ an& clai%e& in he 0./- pa en . 1.. +pon in!or%a ion an& "elie!, he %an5!ac 5re o! San&o'0$ Den&a%5$ ine Pro&5c

i$ %a&e 5$in# he $oli& !or% o! "en&a%5$ ine h*&rochlori&e &e$cri"e& in one or %ore clai%$ o! he 0./- pa en .

12.

San&o'0$ 5$e o! he $oli& !or% o! "en&a%5$ ine h*&rochlori&e in he %an5!ac 5re

o! San&o'0$ Den&a%5$ ine Pro&5c in!rin#e$ one or %ore clai%$ o! he 0./- pa en . 1@. +pon in!or%a ion an& "elie!, San&o' plan$ an& in en&$ o, an& 6ill, in!rin#e he

0./- pa en i%%e&ia el* an& i%%inen l* 5pon approval o! he San&o' ANDA. 1,. +pon in!or%a ion an& "elie!, San&o', 5n&er 1. +.S.C. ? /@(("), ac e& in concer ,

ac ivel* $5ppor e&, par icipa e& in, enco5ra#e&, an&Cor in&5ce& he in!rin#e%en o! one or %ore clai%$ o! he 0./- pa en . 13. +pon in!or%a ion an& "elie!, San&o' plan$ an& in en&$ o, an& 6ill, ac ivel*

in&5ce in!rin#e%en o! he 0./- pa en 6hen he San&o' ANDA i$ approve&, an& plan$ an& in en&$ o, an& 6ill, &o $o i%%e&ia el* an& i%%inen l* 5pon approval. -4. +pon in!or%a ion an& "elie!, San&o' 7no6$ ha he $oli& !or% o! "en&a%5$ ine

h*&rochlori&e 5$e& o %an5!ac 5re San&o'0$ Den&a%5$ ine Pro&5c i$ e$peciall* %a&e or a&ap e& !or 5$e in in!rin#in# he 0./- pa en an& ha he $oli& !or% o! "en&a%5$ ine

h*&rochlori&e 5$e& o %an5!ac 5re San&o'0$ Den&a%5$ ine Pro&5c i$ no $5i a"le !or $5"$ an ial non;in!rin#in# 5$e$. +pon in!or%a ion an& "elie!, San&o' plan$ an& in en&$ o, an& 6ill,

con ri"5 e o he in!rin#e%en o! he 0./- pa en i%%e&ia el* an& i%%inen l* 5pon approval o! he San&o' ANDA. -(. )he !ore#oin# ac ion$ "* San&o' con$ i 5 e an&Cor 6o5l& con$ i 5 e in!rin#e%en

o! he 0./- pa en , ac ive in&5ce%en o! in!rin#e%en o! he 0./- pa en an&Cor con ri"5 ion o he in!rin#e%en "* o her$ o! he 0./- pa en . -/. +pon in!or%a ion an& "elie!, San&o' ac e& 6i ho5 a rea$ona"le "a$i$ !or

"elievin# ha i 6o5l& no "e lia"le !or in!rin#in# he 0./- pa en , ac ivel* in&5cin# in!rin#e%en o! he 0./- pa en an&Cor con ri"5 in# o he in!rin#e%en "* o her$ o! he 0./- pa en .

-1.

Cephalon 6ill "e $5"$ an iall* an& irrepara"l* har%e& "* San&o'0$ in!rin#in#

ac ivi ie$ 5nle$$ he Co5r enAoin$ ho$e ac ivi ie$. Cephalon 6ill have no a&eJ5a e re%e&* a la6 i! San&o' i$ no enAoine& !ro% he co%%ercial %an5!ac 5re, 5$e, o!!er o $ell, $ale in an& i%por a ion in o he +ni e& S a e$ o! San&o'0$ Den&a%5$ ine Pro&5c . --. San&o'0$ ac ivi ie$ ren&er hi$ ca$e an e<cep ional one, an& Cephalon i$ en i le& o

an a6ar& o! heir rea$ona"le a orne* !ee$ 5n&er 1. +.S.C. ? /,.. COUNT II FOR DECLARATOR6 JUD+MENT OF INFRIN+MENT OF U.S. PATENT NO. 5,//-,-./ )6 SANDO7 -.. )he alle#a ion$ o! he procee&in# para#raph$ (K-- are realle#e& an& incorpora e&

herein "* re!erence. -2. +pon in!or%a ion an& "elie!, San&o' plan$ o "e#in %an5!ac 5rin#, %ar7e in#,

$ellin#, o!!erin# o $ell an&Cor i%por in# San&o'0$ Den&a%5$ ine Pro&5c $oon a! er 8DA approval o! he San&o'0$ ANDA. -@. S5ch con&5c 6ill con$ i 5 e &irec in!rin#e%en o! one or %ore clai%$ on he

0./- pa en 5n&er 1. +.S.C. ? /@((a), in&5ce%en o! in!rin#e%en o! he 0./- pa en 5n&er 1. +.S.C. ? /@(("), an& con ri"5 or* in!rin#e%en 5n&er 1. +.S.C. ? /@((c). -,. San&o'0$ in!rin#in# pa en ac ivi * co%plaine& o! herein i$ i%%inen an& 6ill

"e#in !ollo6in# 8DA approval o! he San&o' ANDA. -3. A$ a re$5l o! he !ore#oin# !ac $, here i$ a real, $5"$ an ial, an& con in5in#

A5$ icia"le con rover$* "e 6een Cephalon an& San&o' a$ o lia"ili * !or he in!rin#e%en o! he 0./- pa en . San&o'0$ ac ion$ have crea e& in Cephalon a rea$ona"le apprehen$ion o! irrepara"le har% an& lo$$ re$5l in# !ro% San&o'0$ hrea ene& i%%inen ac ion$. .4. 0./- pa en . +pon in!or%a ion an& "elie!, San&o' 6ill 7no6in#l* an& 6ill!5ll* in!rin#e he

.(. 0./- pa en .

Cephalon 6ill "e irrepara"l* har%e& i! San&o' i$ no enAoine& !ro% in!rin#in# he

COUNT III FOR INFRIN+EMENT OF U.S. PATENT NO. 5,/89,012 )6 SANDO7 ./. )he alle#a ion$ o! he procee&in# para#raph$ (K.( are realle#e& an& incorpora e&

herein "* re!erence. .1. )he 5$e o! San&o'0$ Den&a%5$ ine Pro&5c i$ covere& "* one or %ore clai%$ o!

he 0(34 pa en . .-. )he co%%ercial %an5!ac 5re, 5$e, o!!er !or $ale, $ale, %ar7e in#, &i$ ri"5 ion

an&Cor i%por a ion o! San&o'0$ Den&a%5$ ine Pro&5c 6o5l& in!rin#e one or %ore clai%$ o! he 0(34 pa en . ... +n&er 1. +.S.C. ? /@((e)(/)(A), San&o'0$ $5"%i$$ion o 8DA o! he San&o'

ANDA o o" ain approval !or San&o'0$ Den&a%5$ ine Pro&5c 6i h a Para#raph IG Cer i!ica ion rela e& here o "e!ore he e<pira ion o! he 0(34 pa en con$ i 5 e$ an ac o! in!rin#e%en , an& i! approve&, he co%%ercial %an5!ac 5re, 5$e, o!!er o $ell, $ale, or i%por a ion o! San&o'0$ Den&a%5$ ine Pro&5c con ainin# "en&a%5$ ine h*&rochlori&e, 6o5l& in!rin#e one or %ore clai%$ o! he 0(34 pa en . .2. San&o' 6a$ a6are o! he 0(34 pa en 6hen en#a#in# in he$e 7no6in# an&

p5rpo$e!5l ac ivi ie$ an& 6a$ a6are ha !ilin# he San&o' ANDA 6i h San&o'0$ Para#raph IG Cer i!ica ion 6i h re$pec o he 0(34 pa en con$ i 5 e& an ac o! in!rin#e%en o! he 0(34 pa en . .@. +pon in!or%a ion an& "elie!, San&o'0$ Den&a%5$ ine Pro&5c con ain$ he $a%e

ac ive phar%ace5 ical in#re&ien , "en&a%5$ ine h*&rochlori&e, a$ ha 5$e& in Cephalon0$ )9EANDA: pro&5c $ an& clai%e& in he 0(34 pa en .

.,.

+pon in!or%a ion an& "elie!, he %an5!ac 5re o! San&o'0$ Den&a%5$ ine Pro&5c

i$ %a&e "* l*ophili'in# he "en&a%5$ ine h*&rochlori&e phar%ace5 ical co%po$i ion$ &e$cri"e& in one or %ore clai%$ o! he 0(34 pa en . .3. San&o'0$ 5$e o! a l*ophili'e& "en&a%5$ ine h*&rochlori&e phar%ace5 ical

co%po$i ion in he %an5!ac 5re o! San&o'0$ Den&a%5$ ine Pro&5c in!rin#e$ one or %ore clai%$ o! he 0(34 pa en . 24. +pon in!or%a ion an& "elie!, San&o' plan$ an& in en&$ o, an& 6ill, in!rin#e he

0(34 pa en i%%e&ia el* an& i%%inen l* 5pon approval o! he San&o' ANDA. 2(. +pon in!or%a ion an& "elie!, San&o', 5n&er 1. +.S.C. ? /@(("), ac e& in concer ,

ac ivel* $5ppor e&, par icipa e& in, enco5ra#e&, an&Cor in&5ce& he in!rin#e%en o! one or %ore clai%$ o! he 0(34 pa en . 2/. +pon in!or%a ion an& "elie!, San&o' plan$ an& in en&$ o, an& 6ill, ac ivel*

in&5ce in!rin#e%en o! he 0(34 pa en 6hen he San&o' ANDA i$ approve&, an& plan$ an& in en&$ o, an& 6ill, &o $o i%%e&ia el* an& i%%inen l* 5pon approval. 21. +pon in!or%a ion an& "elie!, San&o' 7no6$ ha he l*ophili'e& "en&a%5$ ine

h*&rochlori&e phar%ace5 ical co%po$i ion 5$e& o %an5!ac 5re San&o'0$ Den&a%5$ ine Pro&5c i$ e$peciall* %a&e or a&ap e& !or 5$e in in!rin#in# he 0(34 pa en an& ha he "en&a%5$ ine h*&rochlori&e phar%ace5 ical co%po$i ion 5$e& o %an5!ac 5re San&o'0$ Den&a%5$ ine Pro&5c i$ no $5i a"le !or $5"$ an ial non;in!rin#in# 5$e$. +pon in!or%a ion an& "elie!, San&o' plan$ an& in en&$ o, an& 6ill, con ri"5 e o he in!rin#e%en o! he 0(34 pa en i%%e&ia el* an& i%%inen l* 5pon approval o! he San&o' ANDA.

(4

2-.

)he !ore#oin# ac ion$ "* San&o' con$ i 5 e an&Cor 6o5l& con$ i 5 e in!rin#e%en

o! he 0(34 pa en , ac ive in&5ce%en o! in!rin#e%en o! he 0(34 pa en an&Cor con ri"5 ion o he in!rin#e%en "* o her$ o! he 0(34 pa en . 2.. +pon in!or%a ion an& "elie!, San&o' ac e& 6i ho5 a rea$ona"le "a$i$ !or

"elievin# ha i 6o5l& no "e lia"le !or in!rin#in# he 0(34 pa en , ac ivel* in&5cin# in!rin#e%en o! he 0(34 pa en an&Cor con ri"5 in# o he in!rin#e%en "* o her$ o! he 0(34 pa en . 22. Cephalon 6ill "e $5"$ an iall* an& irrepara"l* har%e& "* San&o'0$ in!rin#in#

ac ivi ie$ 5nle$$ he Co5r enAoin$ ho$e ac ivi ie$. Cephalon 6ill have no a&eJ5a e re%e&* a la6 i! San&o' i$ no enAoine& !ro% he co%%ercial %an5!ac 5re, 5$e, o!!er o $ell, $ale in an& i%por a ion in o he +ni e& S a e$ o! San&o'0$ Den&a%5$ ine Pro&5c . 2@. San&o'0$ ac ivi ie$ ren&er hi$ ca$e an e<cep ional one, an& Cephalon i$ en i le& o

an a6ar& o! heir rea$ona"le a orne* !ee$ 5n&er 1. +.S.C. ? /,.. COUNT I FOR DECLARATOR6 JUD+MENT OF INFRIN+MENT OF U.S. PATENT NO. 5,/89,012 )6 SANDO7 2,. )he alle#a ion$ o! he procee&in# para#raph$ (K2@ are realle#e& an& incorpora e&

herein "* re!erence. 23. +pon in!or%a ion an& "elie!, San&o' plan$ o "e#in %an5!ac 5rin#, %ar7e in#,

$ellin#, o!!erin# o $ell an&Cor i%por in# San&o'0$ Den&a%5$ ine Pro&5c $oon a! er 8DA approval o! he San&o' ANDA. @4. S5ch con&5c 6ill con$ i 5 e &irec in!rin#e%en o! one or %ore clai%$ on he

0(34 pa en 5n&er 1. +.S.C. ? /@((a), in&5ce%en o! in!rin#e%en o! he 0(34 pa en 5n&er 1. +.S.C. ? /@(("), an& con ri"5 or* in!rin#e%en 5n&er 1. +.S.C. ? /@((c). @(. San&o'0$ in!rin#in# pa en ac ivi * co%plaine& o! herein i$ i%%inen an& 6ill

"e#in !ollo6in# 8DA approval o! he San&o' ANDA.

((

@/.

A$ a re$5l o! he !ore#oin# !ac $, here i$ a real, $5"$ an ial, an& con in5in#

A5$ icia"le con rover$* "e 6een Cephalon an& San&o' a$ o lia"ili * !or he in!rin#e%en o! he 0(34 pa en . San&o'0$ ac ion$ have crea e& in Cephalon a rea$ona"le apprehen$ion o! irrepara"le har% an& lo$$ re$5l in# !ro% San&o'0$ hrea ene& i%%inen ac ion$. @1. 0(34 pa en . @-. 0(34 pa en . PRA6ER FOR RELIEF EHE9E8O9E, Cephalon re$pec !5ll* reJ5e$ he !ollo6in# relie!B a. ". a A5&#%en ha he 0./- an& 0(34 pa en $ are vali& an& en!orcea"leF a A5&#%en ha San&o'0$ $5"%i$$ion o! he San&o' ANDA No. /4-,.4, 6a$ an Cephalon 6ill "e irrepara"l* har%e& i! San&o' i$ no enAoine& !ro% in!rin#in# he +pon in!or%a ion an& "elie!, San&o' 6ill 7no6in#l* an& 6ill!5ll* in!rin#e he

ac o! in!rin#e%en o! one or %ore clai%$ o! he 0./- an& 0(34 pa en $ an& ha he %a7in#, 5$in#, o!!erin# o $ell, $ellin#, %ar7e in#, &i$ ri"5 in#, or i%por in# o! San&o'0$ Den&a%5$ ine Pro&5c $ prior o he e<pira ion o! he 0./- an& 0(34 pa en $ 6ill in!rin#e, ac ivel* in&5ce in!rin#e%en an&Cor con ri"5 e o he in!rin#e%en o! one or %ore clai%$ o! he 0./- an& 0(34 pa en $F c. an Or&er p5r$5an o 1. +.S.C. ? /@((e)(-)(A) provi&in# ha he e!!ec ive &a e o!

an* 8DA approval o! he San&o' ANDA No. /4-,.4 or an* pro&5c or co%po5n& he 5$e o! 6hich in!rin#e$ he 0./- an& 0(34 pa en , $hall "e a &a e ha i$ no earlier han he e<pira ion o! he 0./- or 0(34 pa en F &. an Or&er p5r$5an o 1. +.S.C. ? /@((e)(-)(D) per%anen l* enAoinin# San&o' an&

all per$on$ ac in# in concer 6i h San&o' !ro% co%%erciall* %an5!ac 5rin#, 5$in#, o!!erin# !or

(/

$ale, $ellin#, %ar7e in#, &i$ ri"5 in#, or i%por in# San&o'0$ Den&a%5$ ine Pro&5c $, or an* pro&5c or co%po5n& he 5$e o! 6hich in!rin#e$ he 0./- an& 0(34 pa en $ 5n il, or in&5cin# or con ri"5 in# o he in!rin#e%en o! he 0./- an& 0(34 pa en $ a! er he e<pira ion o! he 0./- an& 0(34 pa en $F e. an Or&er p5r$5an o 1. +.S.C. ? /,1 per%anen l* enAoinin# San&o' an& all

per$on$ ac in# in concer 6i h San&o' !ro% co%%erciall* %an5!ac 5rin#, 5$in#, o!!erin# !or $ale, $ellin#, %ar7e in#, &i$ ri"5 in#, or i%por in# San&o'0$ Den&a%5$ ine Pro&5c $, or an* pro&5c or co%po5n& he 5$e o! 6hich in!rin#e$ he 0./- an& 0(34 pa en $ 5n il, or in&5cin# or con ri"5 in# o he in!rin#e%en o! he 0./- an& 0(34 pa en $ a! er he e<pira ion o! he 0./- an& 0(34 pa en $F !. an Or&er enAoinin# San&o' an& all per$on$ ac in# in concer 6i h San&o' !ro%

$ee7in#, o" ainin#, or %ain ainin# approval o! he San&o' ANDA No. /4-,.4 "e!ore he e<pira ion o! he 0./- an& 0(34 pa en $F #. an a6ar& o! Cephalon0$ &a%a#e$ or o her %one ar* relie! o co%pen$a e

Cephalon i! San&o' en#a#e$ in he co%%ercial %an5!ac 5re, 5$e, o!!er o $ell, $ale or %ar7e in# or &i$ ri"5 ion in, or i%por a ion in o he +ni e& S a e$ o! San&o'0$ Den&a%5$ ine Pro&5c $, or an* pro&5c or co%po5n& he 5$e o! 6hich in!rin#e$ he 0./- an& 0(34 pa en $, or he in&5ce%en or con ri"5 ion o! he !ore#oin#, prior o he e<pira ion o! he 0./- an& 0(34 pa en $ in accor&ance 6i h 1. +.S.C. ? /@((e)(-)(C)F h. a A5&#%en ha hi$ i$ an e<cep ional ca$e an& a6ar&in# Cephalon i $ a orne*$0

!ee$ 5n&er 1. +.S.C. ? /,.F i. an a6ar& o! Cephalon0$ rea$ona"le co$ $ an& e<pen$e$ in hi$ ac ionF an&

(1

A. an& proper.

an a6ar& o! an* !5r her an& a&&i ional relie! o Cephalon a$ hi$ Co5r &ee%$ A5$

Dece%"er 1(, /4(1 O8 CO+NSELB Davi& =. Ha$h%all LOODEIN P9OC)E9 LLP )he Ne6 Mor7 )i%e$ D5il&in# 2/4 Ei#h h Aven5e Ne6 Mor7, NM (44(,;(-4. (/(/) ,(1;,,44 &ha$h%allN#oo&6inproc er.co% Dar*l L. Eie$en E%il* L. 9apalino Nichola$ H. =i ro7o$ a$ E<chan#e Place Do$ on, =A 4/(43 (2(@) .@4;(444 &6ie$enN#oo&6inproc er.co% erapalinoN#oo&6inproc er.co% n%i ro7o$ a$N#oo&6inproc er.co%

DAMA9D, P.A. /s/ Stephen B. Bra erman 9ichar& D. Hir7 (r743//) S ephen D. Dra5er%an ($"-3./) Gane$$a 9. )ira&en e$ (v .13,) Sara E. D5$$iere ($".@/.) /// Dela6are Aven5e, S5i e 344 Eil%in# on, DE (3,4( (14/) 2..;.444 r7ir7N"a*ar&la6.co% $"ra5er%anN"a*ar&la6.co% v ira&en e$N"a*ar&la6.co% $"5$$iereN"a*ar&la6.co% !ttorneys for Plaintiff Cephalon, Inc.

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