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IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF DELAWARE ) ) ) ) ) ) ) ) ) ) ) COMPLAINT Cephalon, Inc. ( Cephalon! o" Plaintiff!

) #"in$% thi% action fo" patent inf"in$e&ent a$ain%t Defendant InnoPha"&a, Inc. ( InnoPha"&a! o" Defendant!). '. (hi% i% an action #) Cephalon a$ain%t InnoPha"&a fo" inf"in$e&ent of *nited

CEPHALON, INC., Plaintiff, v. INNOPHARMA, INC., Defendant.

C.A. No. ___________

+tate% Patent No. ,,--.,./- ( 0./- patent!) and *nited +tate% Patent No. ,,-12,'34 ( 0'34 patent!). (hi% action a"i%e% o5t of InnoPha"&a0% filin$ of an A##"eviated Ne6 D"5$ Application ( ANDA!) %ee7in$ app"oval #) the *nited +tate% 8ood and D"5$ Ad&ini%t"ation ( 8DA!) to %ell $ene"ic ve"%ion% of (REANDA9, Cephalon0% innovative t"eat&ent fo" ch"onic l)&phoc)tic le57e&ia and non:Hod$7in0% l)&pho&a, p"io" to the e;pi"ation of the 0./- and 0'34 patent%. THE PARTIES Cephalon, Inc. /. Plaintiff Cephalon, Inc. i% a co"po"ation ope"atin$ and e;i%tin$ 5nde" the la6% of

Dela6a"e, 6ith it% p"incipal place of #5%ine%% at -' Moo"e% Road, 8"a<e", Penn%)lvania '31... Cephalon i% en$a$ed in the #5%ine%% of "e%ea"ch, develop&ent, &an5fact5"e, and %ale of innovative pha"&ace5tical p"od5ct% th"o5$ho5t the 6o"ld.

InnoPharma, Inc. 1. *pon info"&ation and #elief, Defendant InnoPha"&a i% a co"po"ation o"$ani<ed

and e;i%tin$ 5nde" the la6% of the +tate of Dela6a"e, 6ith it% p"incipal place of #5%ine%% at '4 =ni$ht%#"id$e Road, Pi%cata6a), Ne6 >e"%e) 4,,.-. JURISDICTION AND ENUE S!"#ec$ Ma$$er J!r%&'%c$%on -. .. (hi% action fo" patent inf"in$e&ent a"i%e% 5nde" 1. *.+.C. ? /@'. (hi% Co5"t ha% A5"i%diction ove" the %5#Aect &atte" of thi% action p5"%5ant to /,

*.+.C. ?? '11' and '11,(a), and the Decla"ato") >5d$&ent Act, /, *.+.C ?? //4' and //4/. Per&onal J!r%&'%c$%on O(er InnoPharma 2. *pon info"&ation and #elief, thi% Co5"t ha% pe"%onal A5"i%diction ove"

InnoPha"&a at lea%t #eca5%e InnoPha"&aB (') i% inco"po"ated in Dela6a"e and cond5ct% #5%ine%% in thi% >5dicial Di%t"ictC and (/) &a"7et%, di%t"i#5te% andDo" %ell% $ene"ic d"5$% th"o5$ho5t the *nited +tate% and 6ithin the +tate of Dela6a"e and the"efo"e p5"po%ef5ll) avail% it%elf of the p"ivile$e of cond5ctin$ activitie% 6ithin the +tate of Dela6a"e. InnoPha"&a ha% al%o co&&itted, o" aided, a#etted, cont"i#5ted to andDo" pa"ticipated in the co&&i%%ion of, the to"tio5% action of patent inf"in$e&ent that ha% led to fo"e%eea#le ha"& and inA5") to Cephalon, 6hich &an5fact5"e% (REANDA9, fo" %ale and 5%e th"o5$ho5t the *nited +tate%, incl5din$ the +tate of Dela6a"e. @. *pon info"&ation and #elief, thi% Co5"t al%o ha% pe"%onal A5"i%diction ove"

InnoPha"&a #eca5%e InnoPha"&a p"evio5%l) ha% #een %5ed in thi% >5dicial Di%t"ict and did not challen$e thi% Co5"t0% e;e"tion of pe"%onal A5"i%diction ove" it. See, e.g., Spectrum Pharm. v. InnoPharma, Inc., C.A. No. '/:44/24 (D. Del)C Cumberland Pharm. v. InnoPharma, Inc., C.A. No. '/:442', (D. Del).

/

en!e ,. Een5e i% p"ope" in thi% >5dicial Di%t"ict 5nde" /, *.+.C. ?? '13' and '-44(#). )AC*+ROUND The ,-./ Pa$en$ 3. (he 0./- patent, entitled +olid 8o"&% of Fenda&5%tine H)d"ochlo"ide,! 6a%

d5l) and la6f5ll) i%%5ed on Ma) /', /4'1 to invento"% La5"ent D. Co5"voi%ie", Ro#e"t E. Mc=ean, Han%:>oachi& >Gn%ch, and Ee"oniH5e Co5"voi%ie". '4. Cephalon. ''. 0./- patent. '/. (he 0./- patent i% li%ted in 8DA p5#lication App"oved D"5$ P"od5ct% 6ith Cephalon i% the %ole o6ne" #) a%%i$n&ent of all "i$ht%, title and inte"e%t in the (he na&ed invento"% of the 0./- patent a%%i$ned thei" "i$ht% in the 0./- patent to

(he"ape5tic EH5ivalence Eval5ation%,! co&&onl) "efe""ed to a% the O"an$e Foo7! ( O"an$e Foo7!), 6ith "e%pect to (REANDA9. '1. (he 0./- patent 6ill e;pi"e on Ma"ch /2, /4/3. A t"5e and acc5"ate cop) of the

0./- patent i% attached he"eto a% E;hi#it A. The ,012 Pa$en$ '-. (he 0'34 patent, entitled Fenda&5%tine Pha"&ace5tical Co&po%ition%,! 6a% d5l)

and la6f5ll) i%%5ed on Ma) @, /4'1 to invento"% >a%on Ed6a"d F"ittain and >oe C"ai$ 8"an7lin. '.. Cephalon. '2. 0'34 patent. Cephalon i% the %ole o6ne" #) a%%i$n&ent of all "i$ht%, title and inte"e%t in the (he na&ed invento"% of the 0'34 patent a%%i$ned thei" "i$ht% in the 0'34 patent to

1

'@. ',.

(he 0'34 patent i% li%ted in the O"an$e Foo7 6ith "e%pect to (REANDA9. (he 0'34 patent 6ill e;pi"e on Octo#e" /2, /414. A t"5e and acc5"ate cop) of the

0'34 patent i% attached he"eto a% E;hi#it F. The TREANDA3 Dr!4 Pro'!c$ '3. Cephalon "e%ea"ched, developed, applied fo" and o#tained 8DA app"oval to

&an5fact5"e, %ell, p"o&ote andDo" &a"7et #enda&5%tine h)d"ochlo"ide p"od5ct% 7no6n a% (REANDA9. /4. Cephalon ha% #een %ellin$, p"o&otin$, di%t"i#5tin$ and &a"7etin$ (REANDA9 in

the *nited +tate% %ince /44,. /'. (REANDA9 i% indicated to t"eat ch"onic l)&phoc)tic le57e&ia and non:

Hod$7in0% l)&pho&a. //. Cephalon hold% Ne6 D"5$ Application No. ///-3 and No. //141 5nde" +ection

.4.(a) of the 8ede"al 8ood, D"5$ and Co%&etic Act, /' *.+.C. ? 1..(a), fo" &5ltiple (REANDA9 p"od5ct% 5%ed fo" t"eatin$ ch"onic l)&phoc)tic le57e&ia and non:Hod$7in0% l)&pho&a. The InnoPharma ANDA /1. InnoPha"&a filed 6ith 8DA an A##"eviated Ne6 D"5$ Application 5nde" /'

*.+.C. ? 1..(A) %ee7in$ app"oval to &an5fact5"e, 5%e, offe" fo" %ale, %ell in and i&po"t into the *nited +tate% #enda&5%tine h)d"ochlo"ide po6de" fo" IE (inf5%ion),/. &$Dvial and '44 &$Dvial ( InnoPha"&a0% Fenda&5%tine P"od5ct!) p"io" to the e;pi"ation of the 0./- and 0'34 patent% . /-. /4.-@2. 8DA a%%i$ned the ANDA fo" InnoPha"&a0% Fenda&5%tine P"od5ct the n5&#e"

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/..

InnoPha"&a al%o filed 6ith 8DA, p5"%5ant to /' *.+.C. ? 1..(A)(/)(F)(iv), a

ce"tification alle$in$ that the clai&% of the 0./- and 0'34 patent% a"e invalid, 5nenfo"cea#le andDo" 6o5ld not #e inf"in$ed #) the &an5fact5"e, 5%e, i&po"tation, %ale o" offe" fo" %ale of InnoPha"&a0% Fenda&5%tine P"od5ct ( InnoPha"&a0% Pa"a$"aph IE Ce"tification!). /2. F) lette" dated Nove&#e" ,, /4'1, InnoPha"&a notified Cephalon that it had filed

ANDA No. /4.-@2 %ee7in$ app"oval to &a"7et InnoPha"&a0% Fenda&5%tine P"od5ct p"io" to the e;pi"ation of the 0./- and 0'34 patent% ( InnoPha"&a Notice Lette"!). /@. On Dece&#e" '3, /4'1, p5"%5ant to an Offe" of Confidential Acce%%, Cephalon

"eceived po"tion% of the ANDA filed #) InnoPha"&a, and Cephalon "evie6ed tho%e po"tion% of the ANDA. /,. (hi% Action i% #ein$ co&&enced #efo"e the e;pi"ation of fo"t):five da)% f"o& the

date of "eceipt of the InnoPha"&a Notice Lette". COUNT I 5INFRIN+EMENT OF U.S. PATENT NO. 6,//-,-./ )7 INNOPHARMA8 /3. (he alle$ation% of the p"oceedin$ pa"a$"aph% 'I/, a"e "ealle$ed and inco"po"ated

he"ein #) "efe"ence. 14. (he 5%e of InnoPha"&a0% Fenda&5%tine P"od5ct i% cove"ed #) one o" &o"e clai&%

of the 0./- patent. 1'. (he co&&e"cial &an5fact5"e, 5%e, offe" fo" %ale, %ale, &a"7etin$, di%t"i#5tion

andDo" i&po"tation of InnoPha"&a0% Fenda&5%tine P"od5ct 6o5ld inf"in$e one o" &o"e clai&% of the 0./- patent. 1/. *nde" 1. *.+.C. ? /@'(e)(/)(A), InnoPha"&a0% %5#&i%%ion to 8DA of the

InnoPha"&a ANDA to o#tain app"oval fo" InnoPha"&a0% Fenda&5%tine P"od5ct 6ith a Pa"a$"aph IE Ce"tification "elated the"eto #efo"e the e;pi"ation of the 0./- patent con%tit5te% an

.

act of inf"in$e&ent, and if app"oved, the co&&e"cial &an5fact5"e, 5%e, offe" to %ell, %ale, o" i&po"tation of InnoPha"&a0% Fenda&5%tine P"od5ct containin$ #enda&5%tine h)d"ochlo"ide, 6o5ld inf"in$e one o" &o"e clai&% of the 0./- patent. 11. InnoPha"&a 6a% a6a"e of the 0./- patent 6hen en$a$in$ in the%e 7no6in$ and

p5"po%ef5l activitie% and 6a% a6a"e that filin$ the InnoPha"&a ANDA 6ith InnoPha"&a0% Pa"a$"aph IE Ce"tification 6ith "e%pect to the 0./- patent con%tit5ted an act of inf"in$e&ent of the 0./- patent. 1-. *pon info"&ation and #elief, InnoPha"&a0% Fenda&5%tine P"od5ct contain% the

%a&e active pha"&ace5tical in$"edient, #enda&5%tine h)d"ochlo"ide, a% that 5%ed in Cephalon0% (REANDA9 p"od5ct% and clai&ed in the 0./- patent. 1.. *pon info"&ation and #elief, the &an5fact5"e of InnoPha"&a0% Fenda&5%tine

P"od5ct i% &ade 5%in$ the %olid fo"& of #enda&5%tine h)d"ochlo"ide de%c"i#ed in one o" &o"e clai&% of the 0./- patent. 12. InnoPha"&a0% 5%e of the %olid fo"& of #enda&5%tine h)d"ochlo"ide in the

&an5fact5"e of InnoPha"&a0% Fenda&5%tine P"od5ct inf"in$e% one o" &o"e clai&% of the 0./patent. 1@. *pon info"&ation and #elief, InnoPha"&a plan% and intend% to, and 6ill, inf"in$e

the 0./- patent i&&ediatel) and i&&inentl) 5pon app"oval of the InnoPha"&a ANDA. 1,. *pon info"&ation and #elief, InnoPha"&a, 5nde" 1. *.+.C. ? /@'(#), acted in

conce"t, activel) %5ppo"ted, pa"ticipated in, enco5"a$ed, andDo" ind5ced the inf"in$e&ent of one o" &o"e clai&% of the 0./- patent.

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*pon info"&ation and #elief, InnoPha"&a plan% and intend% to, and 6ill, activel)

ind5ce inf"in$e&ent of the 0./- patent 6hen the InnoPha"&a ANDA i% app"oved, and plan% and intend% to, and 6ill, do %o i&&ediatel) and i&&inentl) 5pon app"oval. -4. *pon info"&ation and #elief, InnoPha"&a 7no6% that the %olid fo"& of

#enda&5%tine h)d"ochlo"ide 5%ed to &an5fact5"e InnoPha"&a0% Fenda&5%tine P"od5ct i% e%peciall) &ade o" adapted fo" 5%e in inf"in$in$ the 0./- patent and that the %olid fo"& of #enda&5%tine h)d"ochlo"ide 5%ed to &an5fact5"e InnoPha"&a0% Fenda&5%tine P"od5ct i% not %5ita#le fo" %5#%tantial non:inf"in$in$ 5%e%. *pon info"&ation and #elief, InnoPha"&a plan% and intend% to, and 6ill, cont"i#5te to the inf"in$e&ent of the 0./- patent i&&ediatel) and i&&inentl) 5pon app"oval of the InnoPha"&a ANDA. -'. (he fo"e$oin$ action% #) InnoPha"&a con%tit5te andDo" 6o5ld con%tit5te

inf"in$e&ent of the 0./- patent, active ind5ce&ent of inf"in$e&ent of the 0./- patent andDo" cont"i#5tion to the inf"in$e&ent #) othe"% of the 0./- patent. -/. *pon info"&ation and #elief, InnoPha"&a acted 6itho5t a "ea%ona#le #a%i% fo"

#elievin$ that it 6o5ld not #e lia#le fo" inf"in$in$ the 0./- patent, activel) ind5cin$ inf"in$e&ent of the 0./- patent andDo" cont"i#5tin$ to the inf"in$e&ent #) othe"% of the 0./- patent. -1. Cephalon 6ill #e %5#%tantiall) and i""epa"a#l) ha"&ed #) InnoPha"&a0%

inf"in$in$ activitie% 5nle%% the Co5"t enAoin% tho%e activitie%. Cephalon 6ill have no adeH5ate "e&ed) at la6 if InnoPha"&a i% not enAoined f"o& the co&&e"cial &an5fact5"e, 5%e, offe" to %ell, %ale in and i&po"tation into the *nited +tate% of InnoPha"&a0% Fenda&5%tine P"od5ct. --. InnoPha"&a0% activitie% "ende" thi% ca%e an e;ceptional one, and Cephalon i%

entitled to an a6a"d of thei" "ea%ona#le atto"ne) fee% 5nde" 1. *.+.C. ? /,..

@

COUNT II 5DECLARATOR7 JUD+MENT OF INFRIN+EMENT OF U.S. PATENT NO. 6,//-,-./ )7 INNOPHARMA8 -.. (he alle$ation% of the p"oceedin$ pa"a$"aph% 'I-- a"e "ealle$ed and inco"po"ated

he"ein #) "efe"ence. -2. *pon info"&ation and #elief, InnoPha"&a plan% to #e$in &an5fact5"in$,

&a"7etin$, %ellin$, offe"in$ to %ell andDo" i&po"tin$ InnoPha"&a0% Fenda&5%tine P"od5ct %oon afte" 8DA app"oval of the InnoPha"&a ANDA. -@. +5ch cond5ct 6ill con%tit5te di"ect inf"in$e&ent of one o" &o"e clai&% on the

0./- patent 5nde" 1. *.+.C. ? /@'(a), ind5ce&ent of inf"in$e&ent of the 0./- patent 5nde" 1. *.+.C. ? /@'(#), and cont"i#5to") inf"in$e&ent 5nde" 1. *.+.C. ? /@'(c). -,. InnoPha"&a0% inf"in$in$ patent activit) co&plained of he"ein i% i&&inent and

6ill #e$in follo6in$ 8DA app"oval of the InnoPha"&a ANDA. -3. A% a "e%5lt of the fo"e$oin$ fact%, the"e i% a "eal, %5#%tantial, and contin5in$

A5%ticia#le cont"ove"%) #et6een Cephalon and InnoPha"&a a% to lia#ilit) fo" the inf"in$e&ent of the 0./- patent. InnoPha"&a0% action% have c"eated in Cephalon a "ea%ona#le app"ehen%ion of i""epa"a#le ha"& and lo%% "e%5ltin$ f"o& InnoPha"&a0% th"eatened i&&inent action%. .4. *pon info"&ation and #elief, InnoPha"&a 6ill 7no6in$l) and 6illf5ll) inf"in$e

the 0./- patent. .'. Cephalon 6ill #e i""epa"a#l) ha"&ed if InnoPha"&a i% not enAoined f"o&

inf"in$in$ the 0./- patent. COUNT III 5INFRIN+EMENT OF U.S. PATENT NO. 6,/9:,012 )7 INNOPHARMA8 ./. (he alle$ation% of the p"oceedin$ pa"a$"aph% 'I.' a"e "ealle$ed and inco"po"ated

he"ein #) "efe"ence.

,

.1.

(he 5%e of InnoPha"&a0% Fenda&5%tine P"od5ct i% cove"ed #) one o" &o"e clai&%

of the 0'34 patent. .-. (he co&&e"cial &an5fact5"e, 5%e, offe" fo" %ale, %ale, &a"7etin$, di%t"i#5tion

andDo" i&po"tation of InnoPha"&a0% Fenda&5%tine P"od5ct 6o5ld inf"in$e one o" &o"e clai&% of the 0'34 patent. ... *nde" 1. *.+.C. ? /@'(e)(/)(A), InnoPha"&a0% %5#&i%%ion to 8DA of the

InnoPha"&a ANDA to o#tain app"oval fo" InnoPha"&a0% Fenda&5%tine P"od5ct 6ith a Pa"a$"aph IE Ce"tification "elated the"eto #efo"e the e;pi"ation of the 0'34 patent con%tit5te% an act of inf"in$e&ent, and if app"oved, the co&&e"cial &an5fact5"e, 5%e, offe" to %ell, %ale, o" i&po"tation of InnoPha"&a0% Fenda&5%tine P"od5ct containin$ #enda&5%tine h)d"ochlo"ide, 6o5ld inf"in$e one o" &o"e clai&% of the 0'34 patent. .2. InnoPha"&a 6a% a6a"e of the 0'34 patent 6hen en$a$in$ in the%e 7no6in$ and

p5"po%ef5l activitie% and 6a% a6a"e that filin$ the InnoPha"&a ANDA 6ith InnoPha"&a0% Pa"a$"aph IE Ce"tification 6ith "e%pect to the 0'34 patent con%tit5ted an act of inf"in$e&ent of the 0'34 patent. .@. *pon info"&ation and #elief, InnoPha"&a0% Fenda&5%tine P"od5ct contain% the

%a&e active pha"&ace5tical in$"edient, #enda&5%tine h)d"ochlo"ide, a% that 5%ed in Cephalon0% (REANDA9 p"od5ct% and clai&ed in the 0'34 patent. .,. *pon info"&ation and #elief, the &an5fact5"e of InnoPha"&a0% Fenda&5%tine

P"od5ct i% &ade #) l)ophili<in$ the #enda&5%tine h)d"ochlo"ide pha"&ace5tical co&po%ition% de%c"i#ed in one o" &o"e clai&% of the 0'34 patent.

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InnoPha"&a0% 5%e of a l)ophili<ed #enda&5%tine h)d"ochlo"ide pha"&ace5tical

co&po%ition in the &an5fact5"e of InnoPha"&a0% Fenda&5%tine P"od5ct inf"in$e% one o" &o"e clai&% of the 0'34 patent. 24. *pon info"&ation and #elief, InnoPha"&a plan% and intend% to, and 6ill, inf"in$e

the 0'34 patent i&&ediatel) and i&&inentl) 5pon app"oval of the InnoPha"&a ANDA. 2'. *pon info"&ation and #elief, InnoPha"&a, 5nde" 1. *.+.C. ? /@'(#), acted in

conce"t, activel) %5ppo"ted, pa"ticipated in, enco5"a$ed, andDo" ind5ced the inf"in$e&ent of one o" &o"e clai&% of the 0'34 patent. 2/. *pon info"&ation and #elief, InnoPha"&a plan% and intend% to, and 6ill, activel)

ind5ce inf"in$e&ent of the 0'34 patent 6hen the InnoPha"&a ANDA i% app"oved, and plan% and intend% to, and 6ill, do %o i&&ediatel) and i&&inentl) 5pon app"oval. 21. *pon info"&ation and #elief, InnoPha"&a 7no6% that the l)ophili<ed

#enda&5%tine h)d"ochlo"ide pha"&ace5tical co&po%ition 5%ed to &an5fact5"e InnoPha"&a0% Fenda&5%tine P"od5ct i% e%peciall) &ade o" adapted fo" 5%e in inf"in$in$ the 0'34 patent and that the #enda&5%tine h)d"ochlo"ide pha"&ace5tical co&po%ition 5%ed to &an5fact5"e InnoPha"&a0% Fenda&5%tine P"od5ct i% not %5ita#le fo" %5#%tantial non:inf"in$in$ 5%e%. *pon info"&ation and #elief, InnoPha"&a plan% and intend% to, and 6ill, cont"i#5te to the inf"in$e&ent of the 0'34 patent i&&ediatel) and i&&inentl) 5pon app"oval of the InnoPha"&a ANDA. 2-. (he fo"e$oin$ action% #) InnoPha"&a con%tit5te andDo" 6o5ld con%tit5te

inf"in$e&ent of the 0'34 patent, active ind5ce&ent of inf"in$e&ent of the 0'34 patent andDo" cont"i#5tion to the inf"in$e&ent #) othe"% of the 0'34 patent.

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*pon info"&ation and #elief, InnoPha"&a acted 6itho5t a "ea%ona#le #a%i% fo"

#elievin$ that it 6o5ld not #e lia#le fo" inf"in$in$ the 0'34 patent, activel) ind5cin$ inf"in$e&ent of the 0'34 patent andDo" cont"i#5tin$ to the inf"in$e&ent #) othe"% of the 0'34 patent. 22. Cephalon 6ill #e %5#%tantiall) and i""epa"a#l) ha"&ed #) InnoPha"&a0%

inf"in$in$ activitie% 5nle%% the Co5"t enAoin% tho%e activitie%. Cephalon 6ill have no adeH5ate "e&ed) at la6 if InnoPha"&a i% not enAoined f"o& the co&&e"cial &an5fact5"e, 5%e, offe" to %ell, %ale in and i&po"tation into the *nited +tate% of InnoPha"&a0% Fenda&5%tine P"od5ct. 2@. InnoPha"&a0% activitie% "ende" thi% ca%e an e;ceptional one, and Cephalon i%

entitled to an a6a"d of thei" "ea%ona#le atto"ne) fee% 5nde" 1. *.+.C. ? /,.. COUNT I 5DECLARATOR7 JUD+MENT OF INFRIN+EMENT OF U.S. PATENT NO. 6,/9:,012 )7 INNOPHARMA8 2,. (he alle$ation% of the p"oceedin$ pa"a$"aph% 'I2@ a"e "ealle$ed and inco"po"ated

he"ein #) "efe"ence. 23. *pon info"&ation and #elief, InnoPha"&a plan% to #e$in &an5fact5"in$,

&a"7etin$, %ellin$, offe"in$ to %ell andDo" i&po"tin$ InnoPha"&a0% Fenda&5%tine P"od5ct %oon afte" 8DA app"oval of the InnoPha"&a ANDA. @4. +5ch cond5ct 6ill con%tit5te di"ect inf"in$e&ent of one o" &o"e clai&% on the

0'34 patent 5nde" 1. *.+.C. ? /@'(a), ind5ce&ent of inf"in$e&ent of the 0'34 patent 5nde" 1. *.+.C. ? /@'(#), and cont"i#5to") inf"in$e&ent 5nde" 1. *.+.C. ? /@'(c). @'. InnoPha"&a0% inf"in$in$ patent activit) co&plained of he"ein i% i&&inent and

6ill #e$in follo6in$ 8DA app"oval of the InnoPha"&a ANDA. @/. A% a "e%5lt of the fo"e$oin$ fact%, the"e i% a "eal, %5#%tantial, and contin5in$

A5%ticia#le cont"ove"%) #et6een Cephalon and InnoPha"&a a% to lia#ilit) fo" the inf"in$e&ent of

''

the 0'34 patent. InnoPha"&a0% action% have c"eated in Cephalon a "ea%ona#le app"ehen%ion of i""epa"a#le ha"& and lo%% "e%5ltin$ f"o& InnoPha"&a0% th"eatened i&&inent action%. @1. *pon info"&ation and #elief, InnoPha"&a 6ill 7no6in$l) and 6illf5ll) inf"in$e

the 0'34 patent. @-. Cephalon 6ill #e i""epa"a#l) ha"&ed if InnoPha"&a i% not enAoined f"o&

inf"in$in$ the 0'34 patent. PRA7ER FOR RELIEF JHERE8ORE, Cephalon "e%pectf5ll) "eH5e%t the follo6in$ "eliefB a. #. a A5d$&ent that the 0./- and 0'34 patent% a"e valid and enfo"cea#leC a A5d$&ent that InnoPha"&a0% %5#&i%%ion of the InnoPha"&a ANDA No. /4.-@2,

6a% an act of inf"in$e&ent of one o" &o"e clai&% of the 0./- and 0'34 patent% and that the &a7in$, 5%in$, offe"in$ to %ell, %ellin$, &a"7etin$, di%t"i#5tin$, o" i&po"tin$ of InnoPha"&a0% Fenda&5%tine P"od5ct% p"io" to the e;pi"ation of the 0./- and 0'34 patent% 6ill inf"in$e, activel) ind5ce inf"in$e&ent andDo" cont"i#5te to the inf"in$e&ent of one o" &o"e clai&% of the 0./- and 0'34 patent%C c. an O"de" p5"%5ant to 1. *.+.C. ? /@'(e)(-)(A) p"ovidin$ that the effective date of

an) 8DA app"oval of the InnoPha"&a ANDA No. /4.-@2 o" an) p"od5ct o" co&po5nd the 5%e of 6hich inf"in$e% the 0./- o" 0'34 patent, %hall #e a date that i% not ea"lie" than the e;pi"ation of the 0./- o" 0'34 patentC d. an O"de" p5"%5ant to 1. *.+.C. ? /@'(e)(-)(F) pe"&anentl) enAoinin$ InnoPha"&a

and all pe"%on% actin$ in conce"t 6ith InnoPha"&a f"o& co&&e"ciall) &an5fact5"in$, 5%in$, offe"in$ fo" %ale, %ellin$, &a"7etin$, di%t"i#5tin$, o" i&po"tin$ InnoPha"&a0% Fenda&5%tine P"od5ct%, o" an) p"od5ct o" co&po5nd the 5%e of 6hich inf"in$e% the 0./- o" 0'34 patent 5ntil, o"

'/

ind5cin$ o" cont"i#5tin$ to the inf"in$e&ent of the 0./- o" 0'34 patent afte" the e;pi"ation of the 0./- o" 0'34 patentC e. an O"de" p5"%5ant to 1. *.+.C. ? /,1 pe"&anentl) enAoinin$ InnoPha"&a and all

pe"%on% actin$ in conce"t 6ith InnoPha"&a f"o& co&&e"ciall) &an5fact5"in$, 5%in$, offe"in$ fo" %ale, %ellin$, &a"7etin$, di%t"i#5tin$, o" i&po"tin$ InnoPha"&a0% Fenda&5%tine P"od5ct%, o" an) p"od5ct o" co&po5nd the 5%e of 6hich inf"in$e% the 0./- o" 0'34 patent 5ntil, o" ind5cin$ o" cont"i#5tin$ to the inf"in$e&ent of the 0./- o" 0'34 patent afte" the e;pi"ation of the 0./- o" 0'34 patentC f. an O"de" enAoinin$ InnoPha"&a and all pe"%on% actin$ in conce"t 6ith

InnoPha"&a f"o& %ee7in$, o#tainin$, o" &aintainin$ app"oval of the InnoPha"&a ANDA No. /4.-@2 #efo"e the e;pi"ation of the 0./- and 0'34 patentC $. an a6a"d of Cephalon0% da&a$e% o" othe" &oneta") "elief to co&pen%ate

Cephalon if InnoPha"&a en$a$e% in the co&&e"cial &an5fact5"e, 5%e, offe" to %ell, %ale o" &a"7etin$ o" di%t"i#5tion in, o" i&po"tation into the *nited +tate% of InnoPha"&a0% Fenda&5%tine P"od5ct%, o" an) p"od5ct o" co&po5nd the 5%e of 6hich inf"in$e% the 0./- o" 0'34 patent, o" the ind5ce&ent o" cont"i#5tion of the fo"e$oin$, p"io" to the e;pi"ation of the 0./- o" 0'34 patent in acco"dance 6ith 1. *.+.C. ? /@'(e)(-)(C)C h. a A5d$&ent that thi% i% an e;ceptional ca%e and a6a"din$ Cephalon it% atto"ne)%0

fee% 5nde" 1. *.+.C. ? /,.C i. A. and p"ope". an a6a"d of Cephalon0% "ea%ona#le co%t% and e;pen%e% in thi% actionC and an a6a"d of an) f5"the" and additional "elief to Cephalon a% thi% Co5"t dee&% A5%t

'1

Dece&#e" /4, /4'1 O8 CO*N+ELB David M. Ha%h&all KOODJIN PROC(ER LLP (he Ne6 Lo"7 (i&e% F5ildin$ 2/4 Ei$hth Aven5e Ne6 Lo"7, NL '44',:'-4. (/'/) ,'1:,,44 dha%h&allM$ood6inp"octe".co& Da")l L. Jie%en E&il) L. Rapalino Nichola% =. Mit"o7o%ta% KOODJIN PROC(ER LLP E;chan$e Place Fo%ton, MA 4/'43 (2'@) .@4:'444 d6ie%enM$ood6inp"octe".co& e"apalinoM$ood6inp"octe".co& n&it"o7o%ta%M$ood6inp"octe".co&

FALARD, P.A. /s/ Stephen B. Brauerman Richa"d D. =i"7 ("743//) +tephen F. F"a5e"&an (%#-3./) Eane%%a R. (i"adente% (vt.13,) +a"a E. F5%%ie"e (%#.@/.) /// Dela6a"e Aven5e, +5ite 344 Jil&in$ton, DE '3,4' (14/) 2..:.444 "7i"7M#a)a"dla6.co& %#"a5e"&anM#a)a"dla6.co& vti"adente%M#a)a"dla6.co& %#5%%ie"eM#a)a"dla6.co& Attorneys for Plaintiff Cephalon, Inc.

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