IN THE UNITED STATES DISTRICT COURT

FOR THE SOUTHERN DISTRICT OF FLORIDA

ASTRAZENECA AB,
P l a i n t i f f ,
Ci v i l Act i on No.
v .
AP OTEX CORP . a n d AP OTEX INC.,
Def en da n t s.
COMP LAINT
P l a i n t i f f Ast ra Zen eca AB ("Ast ra Zen eca "), by i t s a t t orn eys, hereby a l l eg es a s f ol l ow s:
NATURE OF THE ACTION
1 . Thi s i s a n a ct i on f or p a t en t i n f ri n g em en t a ri si n g un der t he p a t en t l a w s of t he
Un i t ed St a t es, Ti t l e 35, Un i t ed St a t es Code, a g a i n st def en da n t s Ap ot ex In c. a n d Ap ot ex Corp .
(col l ect i v el y, "Ap ot ex"). Thi s a ct i on rel a t es t o Abbrev i a t ed New Drug Ap p l i ca t i on ("ANDA")
No. 206067 f i l ed by Ap ot ex w i t h t he U.S. Food a n d Drug Adm i n i st ra t i on ("FDA") f or a p p rov a l
t o m a rket 2.5 m g a n d 5 m g sa xa g l i p t i n hydrochl ori de t a bl et s, g en eri c v ersi on s of Ast ra Zen eca 's
ONGLYZA~ drug p roduct , p ri or t o exp i ra t i on of U.S. P a t en t No. 7,951 ,400 ("t he '400 p a t en t ")
P ARTIES
2. P l a i n t i f f Ast ra Zen eca i s a com p a n y op era t i n g a n d exi st i n g un der t he l a w s of
Sw eden , w i t h i t s p ri n ci p a l p l a ce of busi n ess a t 5-1 51 85 Sodert a l j e, Sw eden .
3. P l a i n t i f f 's subsi di a ry, Ast ra Zen eca P ha rm a ceut i ca l s LP , i s a l i m i t ed p a rt n ershi p
op era t i n g a n d exi st i n g un der t he l a w s of Del a w a re, w i t h i t s p ri n ci p a l p l a ce of busi n ess a t 1 800
Con cord P i ke, Wi l m i n g t on , Del a w a re 1 9803.
3501 8523.1
4. AstraZeneca i s engaged i n th e b u si ness of creati ng, developi ng, and b ri ngi ng to
market revolu ti onary b i oph armaceu ti cal produ cts to h elp pati ents prevai l agai nst seri ou s
di seases, i nclu di ng treatments for Ty pe I I di ab etes. Th rou gh i ts su b si di ary , AstraZeneca
Ph armaceu ti cals LP, AstraZeneca markets and sells ONGLYZA~ i n th i s j u di ci al di stri ct and
th rou gh ou t th e Uni ted S tates.
5. Upon i nformati on and b eli ef, Apotex I nc. i s a corporati on organi zed u nder th e
laws of Canada, h avi ng a pri nci pal place of b u si ness at 150 S i gnet Dri ve, Toronto, Ontari o M9L
1 T9, Canada.
6. Upon i nformati on and b eli ef, Apotex Corp. i s a corporati on organi zed u nder th e
laws of th e S tate of Delaware, h avi ng a pri nci pal place of b u si ness at 2400 North Commerce
Parkway , S u i te 400, Weston, F lori da 33326.
7. Upon i nformati on and b eli ef, Apotex Corp. i s a su b si di ary of Apotex I nc.
JURI S DI CTI ON AND VENUE
8 . Th i s acti on ari ses u nder th e patent laws of th e Uni ted S tates, 35 U.S .C. 100, et
seq ., and th i s Cou rt h as j u ri sdi cti on over th e su b j ect matter of th i s acti on u nder 28 U.S .C.
1331, 1338 ( a) , 2201, and 2202.
9. Venu e i s proper i n th i s Cou rt u nder 28 U.S .C. 1391 and 1400( b ) .
10. Th i s Cou rt h as j u ri sdi cti on over Apotex Corp. b ecau se, u pon i nformati on and
b eli ef, Apotex Corp. h as a pri nci pal place of b u si ness at 2400 North Commerce Parkway , S u i te
400, Weston, F lori da 33326.
11. Th i s Cou rt h as j u ri sdi cti on over Apotex I nc. b ecau se, i nter ali a, i ts su b si di ary and
agent, Apotex Corp., u pon i nformati on and b eli ef, h as a pri nci pal place of b u si ness at 2400
North Commerce Parkway , S u i te 400, Weston, F lori da 33326 and fi led ANDA No. 206067 as
Apotex I nc.' s agent and u nder Apotex I nc.' s di recti on and control.
35018 523.1 - 2 -
1 2 . This Court a l so ha s j urisd ic tion ov e r the d e f e n d a n ts b e c a use , in te r a l ia , this a c tion
a rise s f rom a c tiv itie s of the d e f e n d a n ts d ire c te d towa rd F l orid a a n d the d e f e n d a n ts ha v e
p urp ose f ul l y a v a il e d the mse l v e s of the rig hts a n d b e n e f its of F l orid a l a w b y e n g a g in g in
sy ste ma tic a n d c on tin uous c on ta c ts with F l orid a . Up on in f orma tion a n d b e l ie f , the d e f e n d a n ts
re g ul a rl y a n d c on tin uousl y tra n sa c t b usin e ss within the S ta te of F l orid a , in c l ud in g b y se l l in g
p ha rma c e utic a l p rod uc ts in F l orid a , e ithe r on the ir own or throug h a f f il ia te s. Up on in f orma tion
a n d b e l ie f , the d e f e n d a n ts d e riv e sub sta n tia l re v e n ue f rom the sa l e of those p rod uc ts in F l orid a
a n d ha v e a v a il e d the mse l v e s of the p riv il e g e of c on d uc tin g b usin e ss within the S ta te of F l orid a .
1 3 . The d e f e n d a n ts ha v e p re v iousl y b e e n sue d in this j ud ic ia l d istric t without
ob j e c tin g on the b a sis of l a c k of p e rson a l j urisd ic tion a n d ha v e a v a il e d the mse l v e s of this j ud ic ia l
d istric t throug h the a sse rtion of c oun te rc l a ims a n d b y f il in g suit in the S outhe rn D istric t of
F l orid a .
1 4 . F or the se re a son s, a n d f or othe r re a son s tha t wil l b e p re se n te d to the Court if
j urisd ic tion is c ha l l e n g e d , the Court ha s p e rson a l j urisd ic tion ov e r the d e f e n d a n ts.
PATENT-IN-S UIT
1 5 . On Ma y 3 1 , 2 01 1 , the U. S . Pa te n t a n d Tra d e ma rk Of f ic e d ul y a n d l e g a l l y issue d
the '4 00 p a te n t, e n titl e d "Coa te d Ta b l e t F ormul a tion a n d Me thod . " A true a n d c orre c t c op y of
the '4 00 p a te n t is a tta c he d he re to a s Exhib it A. The c l a ims of the '4 00 p a te n t a re v a l id a n d
e n f orc e a b l e . Astra Z e n e c a is the own e r of the '4 00 p a te n t b y a ssig n me n t a n d ha s the rig ht to
e n f orc e it.
1 6 . Astra Z e n e c a is the hol d e r of Ne w D rug Ap p l ic a tion ("ND A") No. 02 2 3 5 0, b y
whic h the F D A g ra n te d a p p rov a l f or the ma rk e tin g a n d sa l e of 2 . 5 mg a n d 5 mg stre n g th
sa xa g l ip tin hy d roc hl orid e ta b l e ts a s a n a d j un c t to d ie t a n d e xe rc ise to imp rov e g l y c e mic c on trol
in a d ul ts with ty p e 2 d ia b e te s me l l itus in mul tip l e c l in ic a l se ttin g s. Astra Z e n e c a ma rk e ts
3 5 01 85 2 3 . 1 - 3 -
s a x a g l i p t i n h y d r o c h l o r i d e t a b l e t s i n t h e Un i t e d S t a t e s , t h r o ug h i t s s ub s i d i a r y As t r a Ze n e c a
P h a r m a c e ut i c a l s LP , un d e r t h e t r a d e n a m e "ONGLYZA~." Th e FDA's o f f i c i a l p ub l i c a t i o n o f
a p p r o ve d d r ug s ( t h e "Or a n g e Bo o k") i n c l ud e s ONGLYZA~ t o g e t h e r w i t h t h e '400 p a t e n t a n d
U.S . P a t e n t No . RE44, 186, w h i c h c o ve r s t h e c o m p o s i t i o n o f s ~a g l i p t i n .
INFRINGEMENT BY AP OTEX
17 . By l e t t e r d a t e d Ap r i l 21, 2014 ( "t h e No t i c e Le t t e r "), Ap o t e x n o t i f i e d As t r a Ze n e c a
t h a t Ap o t e x Co r p . h a d s ub m i t t e d ANDA No . 206067 t o t h e FDA un d e r S e c t i o n 5 05 ( j ) o f t h e
Fe d e r a l Fo o d , Dr ug , a n d Co s m e t i c Ac t ( 21 U.S .C. 3 5 5 ( j )). As t r a Ze n e c a r e c e i ve d t h e No t i c e
Le t t e r o n o r a b o ut Ap r i 122, 2014.
18. Th e No t i c e Le t t e r s t a t e s t h a t Ap o t e x s e e ks a p p r o va l f r o m t h e FDA t o e n g a g e i n
t h e c o m m e r c i a l m a n uf a c t ur e , us e , a n d s a l e o f g e n e r i c s a x a g l i p t i n h y d r o c h l o r i d e t a b l e t s b e f o r e t h e
e x p i r a t i o n o f t h e '400 p a t e n t . Up o n i n f o r m a t i o n a n d b e l i e f , Ap o t e x i n t e n d s t o e n g a g e i n t h e
c o m m e r c i a l m a n uf a c t ur e , us e , a n d s a l e o f i t s g e n e r i c s a x a g l i p t i n h y d r o c h l o r i d e t a b l e t s a f t e r
r e c e i vi n g FDA a p p r o va l t o d o s o .
19 . By f i l i n g ANDA No . 206067 , Ap o t e x h a s n e c e s s a r i l y r e p r e s e n t e d t o t h e FDA t h a t
i t s g e n e r i c s a x a g l i p t i n h y d r o c h l o r i d e t a b l e t s h a ve t h e s a m e a c t i ve i n g r e d i e n t a s ONGLYZA~,
h a ve t h e s a m e m e t h o d o f a d m i n i s t r a t i o n , d o s a g e f o r m , a n d s t r e n g t h s a s ONGLYZA~, a n d a r e
b i o e q ui va l e n t t o ONGLYZA~.
20. In t h e No t i c e Le t t e r , Ap o t e x s t a t e s t h a t i t s ANDA c o n t a i n s a "P a r a g r a p h IV
c e r t i f i c a t i o n " a s s e r t i n g t h a t t h e '400 p a t e n t i s i n va l i d , un e n f o r c e a b l e a n d / o r w i l l n o t b e i n f r i n g e d
b y t h e c o m m e r c i a l m a n uf a c t ur e , us e , a n d s a l e o f Ap o t e x 's g e n e r i c s a x a g l i p t i n h y d r o c h l o r i d e
t a b l e t s .
21. Th i s Co m p l a i n t i s b e i n g f i l e d b e f o r e t h e e x p i r a t i o n o f t h e f o r t y - f i ve d a y s f r o m t h e
d a t e As t r a Ze n e c a r e c e i ve d t h e No t i c e Le t t e r .
3 5 0185 23 .1 - 4 -
h e r e i n .
COUNT I (INFRINGEMENT OF THE '400 PATENT)
22. Each of t h e p r e ce d i n g p ar ag r ap h s 1 t o 21 i s i n cor p or at e d as i f fu l l y s e t for t h
23. Ap ot e x's s u bmi s s i on of ANDA No. 206067 t o obt ai n ap p r ov al t o e n g ag e i n t h e
comme r ci al man u fact u r e , u s e , offe r t o s e l l , or s al e of g e n e r i c s axag l i p t i n h y d r och l or i d e t abl e t s
p r i or t o t h e e xp i r at i on of t h e '400 p at e n t con s t i t u t e d a t e ch n i cal act of i n fr i n g e me n t . Up on
i n for mat i on an d be l i e f, t h e p r od u ct d e s cr i be d i n ANDA No. 206067 wou l d i n fr i n g e on e or mor e
of t h e cl ai ms of t h e '400 p at e n t u n d e r 35 U. S. C. 271 (e )(2)(A).
24. Up on i n for mat i on an d be l i e f, u p on FDA ap p r ov al of Ap ot e x's ANDA No.
206067, Ap ot e x wi l l fu r t h e r i n fr i n g e at l e as t on e cl ai m of t h e '400 p at e n t by maki n g , u s i n g ,
offe r i n g t o s e l l , an d s e l l i n g i t s g e n e r i c s axag l i p t i n h y d r och l or i d e t abl e t s i n t h e . Un i t e d St at e s
an d / or i mp or t i n g s u ch t abl e t s i n t o t h e Un i t e d St at e s , an d by act i v e l y i n d u ci n g an d con t r i bu t i n g t o
i n fr i n g e me n t by ot h e r s , i n v i ol at i on of 35 U. S. C. 271 (a)- (c) u n l e s s e n j oi n e d by t h e Cou r t .
25. If Ap ot e x's mar ke t i n g an d s al e of g e n e r i c s axag l i p t i n h y d r och l or i d e t abl e t s p r i or
t o e xp i r at i on of t h e '400 p at e n t an d al l ot h e r r e l e v an t e xcl u s i v i t i e s i s n ot e n j oi n e d , As t r aZe n e ca
wi l l s u ffe r s u bs t an t i al an d i r r e p ar abl e h ar m for wh i ch t h e r e i s n o r e me d y at l aw.
PRAYER FOR RELIEF
WHEREFORE, As t r aZe n e ca p r ay s t h at t h i s Cou r t g r an t t h e fol l owi n g r e l i e f:
1 . A j u d g me n t t h at t h e cl ai ms of t h e '400 p at e n t ar e n ot i n v al i d , n ot
u n e n for ce abl e , an d ar e i n fr i n g e d by Ap ot e x's s u bmi s s i on of ANDA No. 206067, an d t h at
Ap ot e x's maki n g , u s i n g , offe r i n g t o s e l l , or s e l l i n g i n t h e Un i t e d St at e s , or i mp or t i n g i n t o t h e
Un i t e d St at e s Ap ot e x's g e n e r i c s axag l i p t i n h y d r och l or i d e t abl e t s wi l l i n fr i n g e t h e '400 p at e n t .
2. An or d e r p u r s u an t t o 35 U. S. C. 271 (e )(4)(A) p r ov i d i n g t h at t h e e ffe ct i v e
d at e of an y ap p r ov al of ANDA No. 206067 s h al l be a d at e wh i ch i s n ot e ar l i e r t h an t h e l at e s t
3501 8523. 1 - 5 -
e x p i r a t i o n d a t e o f t h e '400 p a t e n t , i n c l u d i n g a n y e x t e n s i o n s a n d / o r a d d i t i o n a l p e r i o d s o f
e x c l u s i v i t y t o wh i c h A s t r a Z e n e c a i s o r be c o me s e n t i t l e d .
3 . A n o r d e r p e r ma n e n t l y e n j o i n i n g A p o t e x , i t s a ffi l i a t e s , s u bs i d i a r i e s , a n d
e a c h o f i t s o ffi c e r s , a g e n t s , s e r v a n t s a n d e mp l o ye e s a n d t h o s e a c t i n g i n p r i v i t y o r c o n c e r t wi t h
t h e m, fr o m ma ki n g , u s i n g , o ffe r i n g t o s e l l , o r s e l l i n g i n t h e U n i t e d S t a t e s , o r i mp o r t i n g i n t o t h e
U n i t e d S t a t e s A p o t e x 's g e n e r i c s a x a g l i p t i n h yd r o c h l o r i d e t a bl e t s u n t i l a ft e r t h e l a t e s t e x p i r a t i o n
d a t e o f t h e '400 p a t e n t , i n c l u d i n g a n y e x t e n s i o n s a n d / o r a d d i t i o n a l p e r i o d s o f e x c l u s i v i t y t o
wh i c h A s t r a Z e n e c a i s o r be c o me s e n t i t l e d .
4. Da ma g e s o r o t h e r mo n e t a r y r e l i e f t o A s t r a Z e n e c a i f A p o t e x e n g a g e s i n
c o mme r c i a l ma n u fa c t u r e , u s e , o ffe r s t o s e l l , s a l e , o r i mp o r t a t i o n i n o r i n t o t h e U n i t e d S t a t e s o f
A p o t e x 's g e n e r i c s a x a g l i p t i n h yd r o c h l o r i d e . t a bl e t s p r i o r t o t h e l a t e s t e x p i r a t i o n d a t e o f t h e '400
p a t e n t , i n c l u d i n g a n y e x t e n s i o n s a n d / o r a d d i t i o n a l p e r i o d s o f e x c l u s i v i t y t o wh i c h A s t r a Z e n e c a i s
o r be c o me s e n t i t l e d .
5 . S u c h fu r t h e r a n d o t h e r r e l i e f a s t h i s Co u r t d e e ms p r o p e r a n d j u s t , i n c l u d i n g
a n y a p p r o p r i a t e r e l i e f u n d e r 3 5 U . S . C. 285 .
3 5 0185 23 . 1 - 6 -
DATED: June 4, 2014
s / Jo h n A. Camp
JOHN A. CAMP
F l o r i d a Bar No . 848115
CARLTON F IELDS JORDEN BURT, P.A.
100 S.E. 2nd St r eet
Sui t e 4200
Mi ami , F l o r i d a 33131
Tel eph o ne: (305) 530-0050
F ac s i mi l e: (305) 530-0055
Emai l : j c amp(a~ c f j b l aw .c o m
Ch r i s S. Co ut r o ul i s
F l o r i d a Bar No . 300705
CARLTON F IELDS JORDEN BURT, P.A
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Tampa, F l o r i d a 33607
Tel eph o ne: (813) 223-7000
F ac s i mi l e: (813) 229-4133
Emai l : c c o ut r o ul i s (a~ ` f b l aw .c o m
OF COUNSEL:
MCCARTER &ENGLISH, LLP
Mi c h ael P. K el l y (#2295)
Dani el M. Si l ver (#4758)
Renai s s anc e Cent r e
405 N. K i ng St r eet , 8t h F l o o r
Wi l mi ngt o n, Del aw ar e 19801
(302) 984-6300
mkel l y@mc c ar t er .c o m
d s i l ver @mc c ar t er .c o m
At t o r neys f o r Pl ai nt i f f
As t r aZenec a AB
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