Shire Development LLC et al v. Watson Pharmaceuticals, Inc. et al, No. 0:2012cv60862 - Document 358 (S.D. Fla. 2016)
Court Description: OPINION AND ORDER re 305 USCA Mandate. Signed by Judge Donald M. Middlebrooks on 3/25/2016. (asl)
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Shire Development LLC et al v. Watson Pharmaceuticals, Inc. et al Doc. 358 UNI TED STATES DI STRI COURT CT SO U TH ERN D I STR I O F FLO RI A CT D CASE NO .1 60862- V- l 2CI M DDLEBROO KSœ M NN ON SHI DEVELOPM ENT LLC, RE SHI PHARM ACEUTI RE CAL COS LOP NTI V.ES M TED DE MO TECHNOLOGI LI I and VE ME N GI ANII ULI NTERNATI ONAL LI I , M TED Pl i if , antfs W ATSON PHARM ACEUTI CALS,I ., NC W ATSON LABOM TORI ,I ES NC. FLORI DA,W ATSON PHARM A , I ,an NC, d W ATSON LABORATORI l C ., ES,N De enda s f nt. / O PI I N AN D O R D ER N O THI CAUSE c e be or t Cour upon t Fe r l Cic ts M a t i s d S om s f e he t he de a r ui' nda e s ue Sep e t mber 1 201 whih r m a , 5, c e nded t s c s f f t r pr e ngs i ac or nc wih t hi a e or urhe oc edi n c da e t he F d rlCic i Opn o . ( 3 ) Plitfs ( ol ctvel , ç anif' o $ ie' a s r t a e e a r ut ii n DE 05 . anif1 c le i y ç itfs' r t r ' se t h t pl Sh ) Dee nt2 (olectvel , l fnda s'orç as ' i rnge cai 1a 3 ofUnie St es fnda s c l i y ' e nt' i ton' nfi l ms nd De W ) td at Pae 6, 720 (he$' Paen ) lhel abe htilont r mai ngis sf diposton tnt 773, t 1720 t f'. d nc ra he e ni sue or s ii 1 Shie De opmen LLC Shie Pha mac utca De opm e l r vel t r r e i l vel nt nc Cos o Te hnol es m c ogi ., Li td, ndNogr Pha maLi t (/ aGi iniI er tonalLi td) mie a a r mied fk/ ula nt nai mie . 2 W as Pha m a e i l, l t k/ Actvi, l ) Cs as Phama eui s', W as ton r c utca s nc. n/ a a s nc. W ton r c tcal') ton La aores l .- FL t k/ Aca s La aores FL, 1 ) (s as Fl i ',W as n bort i , nc n/ a tvi bort i nc. ç ton orda' W ) to Pha ,l .t k/ Aca sPhama,l . (ç aton Phanna',a W aton Labo ao i ,I . nna nc n/ a tvi r nc) t s W ' nd l s r tres nc (t as La aois' ( l tvey,ç as '. 'W ton bortre ' coleci l ûW ton' ) ) Dockets.Justia.com fom J nuar 25 t ough J nua y 27,201 wih c osng ar ume s he d o M a c 23, 201 r a y hr a r 6, t l i g nt l n r h 6. Bas d on t e de epr s nt lm a t f l ngfndsoff c a concl i oflw .3 e he vi nc e e ed, ke he olowi i a t nd usons a 1 . Pr e alBackzr oc dur ound t Pat nt The ' Patnti lse i t FDA' publc ton tte S 720 e . 720 e s it d n he S ia i il d l Appr ved Dr o ug Pr t wih The a utcEqui l eEvauains'(ommo yknown a t S a Book' oducs t r pe i vaenc l to ' c nl s he û nge or ' ) asco i Li da . ShieDe lpme i t ownerofNe Dnz Applc ton ($ verng al r veo nt s he w g iai 1 NDA' No. ' ) 22000,a i FDA- ppr ve f t m a a t e a s e o mes a i delyed-eea et blt nd s a o d or he nuf c ur nd al f alm ne a r l s a e s c ai ng 12 g mes lm i whih a e c ont ni . aa ne, c r omm e cilz unde t tade r a ied r he r name Li da*. Lil i al ada* s i cae f t i ton o r m iso i a t wih aci ,mid-o- ode at ul r i colts ndi td or he nduc i f e s i n n duls t tve l t m r e ce atve ii a f rt m ant nc ofr m ison oful r tvecolts nd o he i ena e e s i ce ai ii. Com pl nt On M a 8,201 Pli tfs tld t s aci n f r i rnge nt of t 5 ai . y 2, a n if ie hi to o nfi me he 720 Pae t a an t De e d ns u d r t e Hac - a ma Ac (h ç- th W a ma Ac' o t tn g i s fn a t n e h th W x n t te çl c - x n t' r he la $Ac',35U. C.j271. $ t' ) S. The Ha c W a a Ac pe m is a g ne i dr m a a t e t obti a o l t t h- xm n t r t t rc ug nuf c ur r o a n ppr va o ma ke a ge rc ve son of a pr vi l a oved pha m a e i a pr twihoutco uci r t ne i r i e ousy ppr r c utc l oduc t nd tng e nsve a tm e c um i t ss t e tbls t s f t and e f c i nes oft tpr ud, l xpe i nd i - ons ng e t o sa ih he a e y fe tve s ha od n plc oft s s ft a e t a y t t ,t ge i m a a t e mus s i a Abbr vi td ae he t ae y nd fk c ess he ntrc nuf c ur r t ubm t n e ae Ne Dl gApplc ton CI w ' u iai ANDA' t t Fed a Dr Ad nitai (% ' a de tae ' o he erl ug mi srton :FDA' nd monsrt ) ) ta isp o u ti bie uvae tt te b a d d p o u t 21 U. C.j 3 5 i()A)i) Th h t t r d c s o q i ln o h r n e r d c . S. 5 ()2 ( (v . e Ha c W axman Ac r quie t ta ANDA a i nts t ht e r s ha n pplca ubmi a l r gr ph I ' rii ton i is t t a a V'ce tfca i n t pa AN DA ,c r iyi t tt pr uc i s e FDA a o lt m a ke w ilno i r nge a va i e tf ng ha he od t t e ks ppr va o r t l t nf i ny ld 3To t ee t ntt ta fndi off tc tt e c l i ofl , t a e he e ado e a h x e ha ny i ngs ac onsiut onc usons aw hey r r by pt d s s h; t t e e t t any c usons of l w c tt e fndi of f t t ar al o s uc o he xt nt ha oncl i a ons iut i ngs ac , hey e s o a pt d. do e 2 U.. ae t I j35 ()2 ( ( i)l .Th Ac as r q r st a a ANDA a pl a ts b ta S p tn . d 5 ( )A)v i(V) e t lo e uie h t n p i n u mi c de a ld notc t t pa e o r known asa ipa a a I notce' e ani t f ct a t ie ie o he t nt wne , ç r gr ph V i , ' xpli ng he a ual nd l ga bassf t opi on t tt pae i i ld ort tt ge rcpr twilnoti rnge e l i or he ni ha he tnt s nva i ha he ne i oduc l nfi tep tn . I j3 ()2 ( ;s eas 21C. R.j31 9 ( )6 . Th pae to e ma fl a h ae t d 55 ( )B) e lo F. 4.5 c ( ) e tn wn r y ie s tf pae i rnge e wihi f t fve days ofr ceptofa Pa agr ph I notce l t ui or tnt nfi m nt t n ory-i e i r a V i . f he owne fl s t t t FDA ma nota ove t ANDA f t ry m ont oru i a Unie r ies ui, hen he y ppr he or hit hs ntl td St t c t fnds f t def nt bas on non-nfi men , pa e i i t or pa e aes our i or he enda ed i rnge t t nt nvaldiy, t nt u e fr e bit .I j3 5 ()B)i) n n oc a l y d 5 ()5( (i . i i Defnda W as Flrda s te W as s ANDA nu r 20381 (W NDA e nt ton oi ubmitd ton' mbe 7 C Pr duc )t t FDA s ki a ovalt enga i t c o f' o he ee ng ppr o ge n he omme calmmm f t e us , s e,ofer ri acur, e al f f rs l a o i pora i ofW a s sANDA Pr o ae, nd/ r m tton ton' oduct W a s sANDA Pr ti a ge rc . ton' oduc s ne i m e alm i delye r l s t blta c ans1. gm e a a neast a i i r di . s a ne a d-eea e a e nd ont i 2 s l mi he ctve ng e ent W a s sANDA i l t on' ncuded a t r gr ph l 'c tfc i n s ki FDA a ovalbef e t a a V' erii ato ee ng pa ppr or t e r ton oft 5 Pa e . On M a ch 26,201 purua t 21U .S. j3 5 ()B)i) he xpiai he 720 t nt r 2, s nt o C. 5 ()2 ( (v , W a s s nt t Par gr ph t on e he a a c rii ton t Cos o Te hnol es Li ie , Young & e tfca i o m c ogi m td Tho ps Shie US I ,a éshie. W a s s notc i caes t t W a s n Fl i s eks m on, r nc. nd i r ' ' ton' i e ndi t ha t o orda e FDA a ova t ma ke W a s sANDA Pr ppr l o r t ton' oductbef et 9 Pae expies or he 720 tnt r . Pl ntfsfld t i Co pl nta i tDe e nt on M ay 8, 201 wihi f t fve da ai if ie he r m ai gans f nda s 2, t n oryys of r ept of t Pa ag a I no i e lte s and fld a Ame ec i he r r ph V tc et r , ie n nded Compli ( 43)on ant DE Aug t3,201 Pl i if alegei rnge e ofone orm o e ca m soft 5 20 Pa e ag ns us 2. antfs l nfi m nt r li he 7 t nt ai t a 1De e 1 f ndant ( s Count I,a i e a or c rbut y i rnge e oft 9 Pa e by ) nd nduc d nd/ onti or nf i m nt he 720 t nt W as Phama e i l ( Aca s ( ton r c utcas now tvi) Count1) W ihr r t Count1,Pl ntfsalget t 1. t egad o 1 ai if le ha W as Phar ce i l knowi y i ed W aton Pha m a W a s La a ores and/ ton ma utca s ngl nduc s r , t on bor t i , or W aton Fl i t i rngea / conti e t W as Pha s orda o nfi nd or rbut d o ton nna',W as La a ore ' a or s ton bor t i s , nd/ W a s Fl i si rnge e oft 9 Patnt The alo a lget tW a s Phar e ial ton orda' nfi m nt he 720 e . y s le ha ton mac utc s a tvel i ed,e our d,aded,o a te W a s n Pha ma',W a s La r t i s' a or c i y nduc nc age i r bet d t o r s t on bo aore , nd/ W a s Fl i spr pa a i s ison,a flng of W a s s ANDA wih a Pa agr ph I ton orda' e r ton, ubm s i nd ii t on' t r a V c rii ton t t ' Pa e . Pl ntf sa s r t tt s a t consiut i rngeme unde 35 e tfca i o he 720 t nt ai if s e t ha he e c s tt e nfi nt r U. C. 2 . S. j 71 On Aug t23,201 Defnda s fld t i Ans r ( 5 . W ihi t Ans r us 2, e nt ie her we . DE 2) t n he we , W as n Fl i a s rs t c ecams f deca aor r i :( )a de aai t tt i to orda s et wo ountrli or lr t y elef 1 clrton ha her ANDA P o uc wo l n ti rn ea ycam o te 52 Pae t (e DE 5 a 1 - 6 ;a d( )a r d t ud o nfi g n li f h 7 0 tn , s e 2 t 51) n 2 de lrto t tt '20 Pat a isdams ae i ld unde 35 U. C.j 11 f lc of caain ha he 7 tnt nd t i r nvai r S. 2, or a k wrten des i i a l c of e blm e ,t t e e t cli a e a lge t c it crpton nd a k na e nt o he xtnt he a ms r le d o over a ny pr t s f t i t W as ANDA.( eDE 5 a 1 1 . oducs et orh n he ton Se 2 t 6- 7) Cl m satl s Pl i if a e as e tng i rnge e ofonl c am s 1 a 3 oft 9 ai s ue. antfs r s ri nfi m nt y li nd he 720 Pa e .Cl i 1i t 1 Pa e ' o y i pende cai ,a pr des: t nt am s he 720 t nts nl nde nt l m nd ovi 1 Contoled-elas or lpha mac utc c postons c a ni . r l r e e a r e ial om ii ont i ng asa a tvei e ents- m i s iylcacd,c n ci ngr di a no- alc i i omprsng: ii a an ime lpophii marx c itng of s t es ) l r i lc ti onssi ubsanc s l c e fom t g oup conssi of uns t a e a or ee td r he r itng a ur t d nd/ hydr nae f ty acd, s ls ese s or a de t r , oge t d at i at , tr mi s he eof f ty a i m ono- di orti yc i ,wa s ce a i s a at c d , - rgl erds xe , r m de , nd c e t r de i tve wih meli poi s beow 90O C. hol se ol rvai s t tng nt l , a whe ei t a tve i edinti dipe s d bot i s d nd r n he c i ngr e s s r e h n ai t lpophii ma rx andi t hyd ophii m arx; he i lc ti n he r lc ti b)a outrhydr lcmarxwheei t lpophii marx n e ophii ti r n he i lc ti i di pe s a s i out r hydr lc m ati cons s s of s s r ed, nd a d e ophii rx it c mp u d slce fo tego pc nssijo poy r o o n s eetd rm h ru o itn f lmes or c opol m e s of a r i or m e ha r i a l a kyl nyl y r c ylc t c ylc c d, l vi p lmes h do y ly c l l e,cro y lyl ell e, oy r, y rx ak l el oss ab x ak c luoss u pol a ha l s de rns pe tns sa c sand de i tve ys cc rde , xtl , c i , t r he rva i s, 4 al ni gi c a d, and ci naur t al o r s hetc ynt i gum s ; c)o i l ot re i ent ptonaly he xcpi s; whe e n t ac i i e e i pr e i a a ountof80 t 95% r i he tve ngr di nt s es nt n n m o by wei of t t t l composton, a wher i t a tve ght he o a ii nd en he c i i e e i dipe s bo h i t lpophii ma rx a i t ngr di nt s s r ed t n he i lc ti nd n he hydr lcma rx. ophii ti 1 20 Pa en a c . 11 77 t t t ol6 . 30. Cl m 3,whih i depe nton cli 1, r cies û ai c s nde am e t : ' postonsasc am e i cai 1 i Com ii li d n l m , n t f m oftblt,c ps es mi a es' (#.. he or a es a ul , ntblt. J )4 ' 201 M ar an H e ng and Tr a . Att r ques oft Pa tes a f l ng cli 3 km ari il he e t he ri , nd olowi am consr c i bretng a a M ar man he rng on De e be 20, 201 l i s d a Or r da e tu ton i i nd k ai cm r 2, s ue n de t d J nuay 1 201 ( 1 ) c tui cet ndiputdcai oft '20Pae . a r 6, 3 DE 47 , onsr ng rai s e l ms he 7 tnt 1h l a n nj r tilfo Ap i 8 t o h Ap i 1 ed o -u y ra r m rl l ug rl 2,201 ,wih co ig a g me t 3 t lsn r u n s e onducedonAprl26,2013(1 3Tra' .Folowi t 201 Tra,Ie eeda Opi o a t i 1 201 il' ) l ng he 3 il ntr n nin nd Or e ( 2 6 : 3 Or e ',fn n t a W as n' ANDA Pr d c ifi g d cams 1a d 3 d r DE 4 , . 201 d r) idig h t to s ' o u t n rn e li n oft 1 Pa e . Spe fcal lf he 720 t nt cii ly, ound t tW a s sANDA Pr ha t on' oduc me t lm iatonsoft t t he i t i he cli st twe e a is If t rf am ha r t s ue. urhe ound t tt c am swer no i ld unde 35 U . S. j 1 2 ha he l i e t nva i r C. 1 f lc ofa wrte de c i i o e bl nt Ih l ta S r wa e tte t ij n tv rle . or a k it n s rpton r na eme . ed h t hie s n ild o nu ci e eif Fe ralCicui Appea . Folo ng t 2013 Or ,W as appe e t t Unie de r t l l wi he der t on ald o he td Stt sFe r lCic t On a al W a s c le ed t 201 consr tonsoft c am tr a e de a r ui. ppe , ton ha lng he 3 tuc i he l i e ms 'i rlpophii m arx' a S e hydr lc m arx,' a t ,my s e nti rngeme inne i lc ti ' nd l r out ophii ti ' nd, hus ubs que nfi nt tndi W a s di notot r s c le t 201 cli consr ton Or rora i ng. ton d he wie ha lnge he 3 am tuc i de ppea a of l ny t ot f cua fndi s he her a t l i ngs uppori t i rnge e detr i ton i t 201 Or r tng he nfi m nt e m na i n he 3 de . 4Bec us c am 3 i de nde on c am 1 i nece s rl c ansa 1oft lm ia i ofcai s pe nt li , t a e li s a iy ont i l he i ttons l m 1 Thus W a s s AN DA Pr t c n onl i rnge c am 3 i i i rnges cai 1. Sa d . , ton' oduc a y nfi li f t nf i lm i dif e l i W a s sANDA Pr tdoe noti rngecli 1, i c fer nty, f t on' oduc s nfi am t annoti rngecli 3. nfi am 5 On M a c 28,201 t Fe r Cic tis d a opi on, a fr i m y c tu i of rh 4, he de al r ui s ue n ni fim ng onsr cton t t r l arx,' but r ve sng my c t u i n of ti e lpophii mati ' a t e he e m s ti ' m e ri onsr cto ll r i m lc rx' nd ' r out hydr lc ma rx. Shie De . LLP v Waton Phar .I ., 746 F. 1 ( d.Ci. 4) ophii ti ' ' r v . s ms nc 3d 326 Fe r 201 (e en fe Was nf. h ria tr to 1 Shie a r ppeaed t Fe r l Cic ts Or r i Waton I t t U .S. Supr e Cour, l he de a r ui' de n s o he em t a gui t tt Fe r Cic tdi notgi pr r ng ha he de al r ui d ve operdef r nce t my f ct lfndi unde l ng ee o a ua i ngs ryi cai c tu ton. Petton f a W rtofCeri a i Shie De ,LLC,v Wat on Phar ., I . l m onsr c i ii or i tor r, r v. . s ms nc , 1 5 S. .1 7 ( 5 @ o 1 - 0 ) TheSu e Co r g a td Shr ' p tto f c rir r, 3 Ct 1 4 201 ) . 4 2 6 . prme u t r ne ie s eiin or e t ai o va td Waton f a r m a d f pr ee ngs c it wih Te Phar eutc s USA, cae s , nd e nde or oc di onssent t va mac ial I c v S n o ,I c,1 5 S. . 31( 01 ) S r De .L C v Was nPh r .I c,1 5S. . n . . a d z n . 3 Ct 8 2 5 . hie v, L . to a ms, n . 3 Ct 11 4 ( 1 . 7 20 5) The pa te e ris ngage i s e e albrefng on r d n upplm nt i i emand t t Fede alCicui, a t o he r r t nd he Fe r Cic tr is isopi on on J 3,201 . ShieDev,LLC v Waton Phar . l ., de al r ui e-s ued t ni une 5 r . . s ms, nc 7 7 F.d 1 9 ( d. r 2 5 (e en he Was n fl l Wa s nI t Fe e a Cic i h l 8 3 35 Fe Ci. 01 ) h r ia r to f. n to L he d rl ru t ed Wat 1di noti iat f c ua tndi t whih i o son d mplc e a t l s ngs o c t wed de e e unde Te a. The Fede a f r nce r v rl Cic tt n r fim e isr ve s lof my consr ton ofûi r lpophii ma rx' a ûo e r ui he ea fr d t e r a tuc i lnne i lc ti ' nd lut r hydr lcmati 'a we la t r r a oft as oc ae i rnge ophii rxy s l s he eve s l he s i td nfi mentfndi . ' i ng 2016 Tral lhel a be h ti lon J nua y 25 t ough J nua y 27, 201 ,t a j d c t i . d nc ra a r hr a r 6 o du iae t r mai ng is he e ni s ue whehert ac us W a s t bl 5i f i st cai d Snne lpo lc t he c ed t on a et n rnge he l me t r i phii i m arx' a t e hydr lc m arx' lmiai nsoft a s red cai s when t e t r a e ti ' nd t r out ophii ti ' i t to he s e t l m , hos e ms r c tu d i a cor nc wih t Fe r Cic tsM a t . onsr e n c da e t he de al r ui' nda e 5 The f onnulton f whih W a s c r nty s e FDA a ovalr m ai t s me a t a i or c ton ure l e ks ppr e ns he a s he f onuulton fom t 201 Tra .See201 Tra Tr Day 1a 200: 24,Si Diec . a i r he 3 i l 6 il . t 20nko r t 6 I. I La o I r neem e w f nf i nt Pu s a t o3 U. C. 27 ( )2 ,t sa a to ifi e n ru n t 5 S. j 1e ( ) ii n c f n rng me t t s b t (n ANDAJ f ra d u came i a p tn o te us ofwhc i o u mi a o r g li d n ae t r h e ih s c am e i a pa e ...i t pum os ofs h s ison i t obt i a ova li d n t nt f he e uc ubm s i s o a n ppr l unde s Ac t e ge i t c me ci manuf c ur us ors e ofa dr . . r uch t o nga n he om r al a t e, e, al ug . c a m e i a pa ent . bef e t li d n t . . or heexpia i ofs h paen . r ton uc t t I W ihi t Ha c W a a co t ,t a t o i rnge d. t n he t h- xm n nt xt he c f nfi mentt t gi rs t a ca e or ha ves i e o s c r r y ha be n not d a ça ttcil' a t s c sc i xng ng co poston ha notye bee ontove s s e e s tris a , s he pe i nfi i ' m ii s t n n a us d,or s d. Gl ,I .v Nov phar Lt ,11 F. 1 , 1 ( d.Ci.1 A de, e ol axo nc . o m, d. 0 3d 562 569 Fe r 997) (ii El Lil & Co.v.Me r c f .496U. 661,675,677( 990). l t eca e Sgl ctng i l y dtoni, nc, S. 1 ) n hes s s,çthe r lva i r i whet rt pae e ha pr ee nt nquiy s he he tnte s oven by apr tponde a e oft e de t tt r nc he vi nce ha he ale i rnge willkel m a ke a i rngi pr uc . 1 a 1570. Tha s i , t wl a i lged nfi r l i y r t n nfi ng od t' d. t ' t ad ç h t s g lkey t be s d, or pr f a y, wha wil be s d, wil uli ael de e m i whe he i l o ol , e er bl t l ol l tm t y t r ne t r i rng m e e ss' I nfi e nt xit . d. ' fW hoe a vel i û ver di y nduce i rnge ntof a paen s l be la e asan i rnge .' 35 s nfi me t t ha l i bl nf i r ' U. C. 2 () Ad iinal 3 U.. j2 ( ) r vie f rc n rb t r i rn e n : S. j 71b . dto l 5 SC. 71c p o d s o o tiu o y nfig me t y, W hoe rofe st s lors l wihi t Unie St t sori ve f r o el els t n he t d a e mporsi o t Unied t nt he t St t s a c ae ompone of a pa e ed m a hi , m a acur , com bi ton or nt t nt c ne nuf t e na i c omposton ...c tt i am aera pa toft i ii onsiutng t il r he nvento knowi t s i n, ng he ame t o be es i l m a or es i l a pt d f us i a i rngeme of s h pecaly de pecaly da e or e n n nfi nt uc paent a nota sa ea tcl orc t , nd t pl ri e omm odiy ofc t omm e ce s t bl f s t nta r uia e or ubsa i l no nfi ngus s l be labl asa c rbut y i rnge . ni rngi e, hal i e onti or nfi r I a j271c . d t () Paenti rng t nfi emen i a q ton of f c ,a a paenti i rnge i a sngl cli i t s uesi a t nd t s nfi d f i e am s i ri nf nged. Ce on, I v. Wat Pharms., I . 7Q7 F. 1 phal nc. son nc, 3d 330,1340,( d.Ci.201 ) Fe r 3) I e v tAm. I .v.Kee vetLabs,I . 887 F. 1 ntr e , nc . nc, 2d 050, 1 ( d.Ci.1 . I i wel 055 Fe r 989) t s l e tbls d t tt i rnge e a l i i vest se . tFis ,t cour de e m i s t sa ihe ha he nfi m nt nayss nvol wo tps l rt he t t r ne he s cope a m e ng oft pa e c am sas e td . . . a t n t pr l consnld cli sa e nd ani he t nt l i s re nd he he opery t e am r c ompa e t t a lgedl i rngi de ce. Cybo Cor . v FAS Te . I . 1 F. 1 , r d o he le y nfi ng vi ' ' r p . chs, nc, 38 2d 448 1 ( Ci.1 . tlo prvai,t pli ifmus esa ih by a prpondeanc oft 454 Fed. r 998) i' e l he antf ' t tbls e r e he e de e t t a cus d de ce i rnges one orm or cli s of t paentet r ltr l or vi nc hat he c e vi nfi e am he t ihe ie aly unde t doc rne ofe valnt.' Ba rAG v El Phar Re e c Cor ,21 F. 1 , r he ti qui e s' 6 ye . an m. s ar h p. 2 3d 241 1 47( d Ci. 0 0 ( iigI stf r T c s,I . .Ca Co ta tn ,I c,1 F.d6 , 9 2 Fe . r 2 0 ) ctn n iuo m e h . nc v r nr cig n . 61 3 68 6 2 ( d.Ci.1 ). Fe r 998) Lier I r nge e .t'' pr lt r nfi m e , a pl ntf mus s t al nf i m nt t o ove ie ali rnge nt f ai if t how t t hat he a c e de c c ansea h a e r Imia i oft a s re c am s' Pr sdi Compone s c us d vie ont i c nd ve y i t ton he s e td l i . ' e i o nt, I c v Am.T c nc Ce a c Co p.7 2F.d 1 51 1 5 ( d. r 2 2 (iig Uni c US n.. e h ial r mis r , 0 3 3 , 3 8 Fe Ci. 01 ) ctn l o A, l c v M ir sh Co p. 6 2F.d 1 9 ,1 0 ( e .Ci. 01 :.Th sma b d n wi dr c o n . . coo r , 3 3 2 2 3 1 F d r2 1 i y e o e t ie t r h cr umsa ile de e,a a pa e e ne notpr e diec e de e of i rng nt 02 ic t nta vi nc nd t nt e ed es nt r t vi nc nfi eme . M ir I ' 1/ v Be c o nt1 J , yond I nnov i Te h.Co. f/ ,449 F.App' 923, 928 ( d.Ci.201 ) aton c , #. x Fe r 1 (ii Luc Tec . I v.Gat y,I . 580 F.d 1 ,1 ( Ci.2009 ;S ctng ent hs, nc. ewa nc, 3 301 318 Fed. r ) ymantc e Cor v ComputrAs ocs 1 ' f ,52 F.d 1 p. . e s . ntl nc. 2 3 279,1 ( d.Ci.2008:. Furher i i , 293 Fe r t ,t s i pr pe t c m o r o ompa e t a e e pr r he c us d odud wih a pr f r d embodi e i t exa esoft t e ere m nt n he mpl he pa e ,i t d ofwih t cai s SeeSR1I 1v. atu hia Elc. Cop.fAm.77 F.d 1 0 , t nt nsea t he l m . nt M s s t e r o , 5 2 17 11 ( Ci.1 ( tto omitd) lfa cam lmiai i a e fo t a c ed 21 Fed. r 985) ciains te . ç ny li i tton s bsnt r m he c us l d c t r i no lt r i rng nta a m at rofl w. 1 . ( i Ba rAG, 2F. a evie, he e s ie al nfi eme s te a ' d quotng ye ' 21 3d t 1 ) 247 . 6Shie o i naly a gue t tW a s sANDA Pr ti rnge ltr ly and undert docti r rgi l r d ha ton' oduc nfi d ie al he rne ofeq vae s. Howe r Shie or l wave isdoc rne of e valnt a gum e t mor ng ui lnt ve , r aly i d t ti qui e s r nt he ni oft 2016 Be h Tral Acc di y,1wilonl c i r whehe W a s sANDA pr t he nc i . or ngl l y onsde t r t on' oduc lt al i rnge t 1 Pae . ier ly nfi s he 720 tnt 8 11 1. Cl m Cons r ton i lghtoft Feder Ci c tM andat ai t uc i n i he al r ui e a. Pr or C ons r t ons i t uc i Folowi t M ar l ng he kman Hemi i my J nua y 1 , 201 Or r( 1 ) Ic n tu d ng, n a r 6 3 de DE 47 , o sr e t f l ng t ms7 he olowi er : Cl m Ter ai m 201 Cons r ton 3 t uc i i nne lpophii ma rx' l ri i lc ti ' a m a rx i l ng a la tone lpo lc e pi t whe e t ti ncudi t e s i phii xci en , r he m arx i l a e wihi o o mor ot rs t nce ti s oc t d t n ne r e he ubsa s t e hydr lcma rx' a ma rx ofa l s one hydr lc exc pi , whe e t marx s r out ophii ti ' ti t ea t ophii i ent r he ti i l t d ou sdet i rlpo lcm arx s oca e t i he nne i phii ti Appl ng t e c tuctons If yi hes onsr i , ound t t W a s s ANDA Pr ha ton' oduc c a ne bo h a t ont i d t n i r lpophii ma rx a out r hydr lc ma rx. nne i le ti nd e ophii ti Dee n W as a ae my f nda t t on ppe l d c tu ton oft e tr ,a t Fe r Cicui r ve s d m y c tuc i . See W at on I , onsr c i hes e ms nd he de al r t e r e onsr tons s 1 737 F. a 1 3d t 365. b. Fe r Ci c tM andat de al r ui e The Fe r l Cicui uphel m y co tuci of ç arx' as :a m a os opi ly de a r t d nsr ton ç ti ' m i cr c ca l homog noussr c ur i a1 isvol e. Waton 1 , F.d a 1 e tu t e n 1 t um ' ' s I 787 3 t 365. W ih r s c t t c am t e pe t o he l i c tu tons of li r lpophii ma rx' a t erhydr lc ma rx,' t Pa tes di a e onsr c i tnne i lc ti ' nd G out ophii ti ' he ri s gr e a boutwha t Fe r lCic thed. t he de a r ui l Fort r a onsdicuse beow,lfnd t tt Fe r Cic thedt t ()ea h marx he e s s sd l i ha he deal rui l ha: 1 c ti mus e bi t i t xhi t l pophii' orçhy ophii ' pr ri s r pec i l , and ( t marce mus be l lc' ' dr lc' ope te , es tvey 2) he ti s t Es 'eparat 'f om each ot . I at 1365e' r her d 68. 1Ico tue addii ldiput a a e d upon cai t r s i t c am c tuc i Or r nsr d tona s ed nd gr e l m e m n he l i onsr ton de ( 1 ,whih wee notdit be on a pe . Ac or ngl li DE 47) c r sur d p al c di y, ncoport t defnii a ae he i ton nd dic son oft et r sby r f r nce.See201 Or ra 5- . s us i hos e m eee 3 de t 6 c. The Ii upophii M at i M us Exhi t Li lc rx t bi pophii Char t rs i s and t lc ac e itc he Hydrophii M at i M us Exhi tH ydr lc rx t bi ophii Char t itc lc ac er si s The Fed a Cic the d t tt i rm arx mus exhi tlpo lc cha a ersi sa er l r ui l ha he nne ti t bi i phii r ct itc nd t o e ma rx m us e bi hy o lc c a t rsi s Waton I 787 F. a 1 66 he ut r ti t xhi t dr phii har c e itc . s L 3d t 365- ( e to IlA o t o no ) S cfc ly te F d rl Cic i hed ta h a j ci e S cin I. f he piin . pe iial, h e ea rut l h tt e de tv çio h l 'me n t a th marx no j ta e cpin wi n t emarx mu te hbtt sp p ii ' a s h t ' e ti t us n x i e t t h ti l c t hi s x ii he si aed-o lpophii pr ri s' 1 . The Fede a Cic t e aned t t S he 1 pa e tpult t i lc ope te . d ' r l r ui xpl i ha l 720 t nt t t c s t tt s oc ur when the m an c ea he ha hi c s t i ompone oft m a rx sr t e'i lpophii .' I nt he ti tuc ur s i lc ' d (iigP OIa l 1 - 8 . ctn TXO t :7 1 ) Fort m e ni ofllpo lc c r c e itcs' t Fe r lCic tl he a ng li phii ha a t rsi s' he de a r ui ooked t t paent o he t s c f ton. See Waton 1 ,787 F.d a 13 . Spect a l t Fe r Cic tcie t t pe ika i s I 3 t 65 ik ly, he de al r ui t d o he pas a de c i ng lpophii c r de itcsa pr di t ome r ssa e t t pe ta i of s ge s rbi i le ha a rsi s ovi ng d s e itnc o he ner ton t s ve td t t poora fniy t r aque tui .' 1 a 1 (ee ngt : Pae he ol n ue o he fi t owa ds ous l ds ' d. t 367 rfni o 720 tnt a c . l.1720) TheFedealCic tas obs ve t tt Patessi aedt tSlpo lc' t oll l - . r rui lo er d ha he ri tpult ha li phii' m e ns t a ' poora f niy t a ds a oustui . Se W at on 1 , 787 F. a 1 f i t ow r que l ds ' e ' s I 3d t 365. The i rnsc r cor as pr de i i ht it t m e ni of thydr lc nti i e d lo ovi s nsg n o he a ng t ophii c r t itc , e t h t Fede a Cicui doe notpr de e es gui nc a i doesf ha acersi s' ven houg he ' rl r t s ovi xpr s da e s t or çi phii c r cersi s' For exn e t : s po lc ha a t itc .' l mpl , he 720 Pa e ' s ii aton des rbes S gh t nts pec fc i ci ç hi r ssa et t pr e soft s vent' us d by t pr e eofS tongl hydr lc gr ' e it nc o he ogr s he ol 'ca e he es nc tr y s ophii oups' t té e r bl i r as svic iy i i t hydr t d l ye .'(7 0Pae ta c ll1.2- ) I ha d ma ka y nc e e s ost nsde he r a e a r ' 1 2 tn t o . 1 26 . n 2 a herpa s ge t 1 20 Paen des i hydr lccha a t rsi a t f m a i ofç hi not s a , he 7 t t crbes ophii r c e itcs s he or ton ç gh a vic iy s ln lye .' (d.a c . 1. 64) Furhe mor t s cfc ton sae t tt s ost wole a r' 1 t o12 160- . t r e, he pe i ai tts ha he s tnc st tc tt e t hydr lcma rx a eknown a thydr l .' (d a c . l. 8ubsa e ha onsiut he ophii ti r s t oge s ' I t ol l1 23; 3 s e alo i a c . 157-014 15) ( crbi t dis uton chaaceitc of t outr e s d. t ol3 . c . . des i ng he sol i r trsis he e hydr lcmarxl. Addii ly,t Pa te havesi aedt t ophii'me t ng ophii ti ) tonal he ris tpult hatç hydr lc' ans s havi a afni t wae . ( 1 Or e a 6 . n fi t o tr' 20 3 d r t ) y ' d. TheLi phii and Hydr lc M at i e M us BeSe at po lc ophii rc s t par e The Fe r Cic talo hel t tt i rlpophii mati a t outr hydr lc de al r ui s d ha he nne i lc rx nd he e ophii marx mus bed e r t ' Waton I 78 F. a 1 68. TheFedealCic thel t tçll ti t t pa ae.' s L 7 3d t 366s r rui d ha sthe pr ec i hit y,t sr t e oft cai is f t or na y mea ng oft c am t , os uton sor he tuc ur he l m tel, he di r ni he l i enns i l i t M a kus gr up lmia i , a t pa e ' des i i oft i nton compe a ncud ng he r h o i t tons nd he t nts crpton he nve i l cli c tu on whi r quie t t t i a m onsr di ch e r s ha he nner lpophii ma rx i s par e fom t o e i lc ti s e at r he ut r hydr lcmarx. I a 1 ( ophii ti ' d. t 366 emphai adde . ' ss d) The or na y m ea ng of t c am t r s pr de one bass f t Fede alCic t s di r ni he l i e m ovi s i or he r r ui' hol ng ofs pa a e ma rce . Wat on I,787 F. at1 67. Forexa pl t Fe alCi c t di e r t ti s s 1 3d 366m e, he der r ui obs r ed t t t i vi e v ha he ndi dual wor Si r' a ' e ' defne t ualy e l i s tal ds tnne ' nd i r' i i out mut l xcusve pa i cha a t rsi s' a t wor çlpophii' and t ophii ' de i ç ut l e usve r c e itc y nd he ' ds ti lc' t hydr lc' fne l ualy xcl i m c ompostonalc r de i tcs' 1 a 1 66. Unde t Fe r lCicui' r s ng, Lone m a rx ii ha a rsi . d. t 3 ' r he de a r ts ea oni Q ti c nnotbe bot i r a out ri a r a i t a s c a h nne nd e n elton o e ond m arx. Norca one m arx be bot ti n ti h hyd o lca lpophii ' 1 a 1 (mpha i adde .Cons nty,asngl sr t emay r phii nd i lc. d. t 367 e ' ss d) eque l i e tucur nots r as bot a lpophii ma rx a a hydr lc ma rx. See i a 1 67. Thus t e ve h i lc ti nd ophii ti d. t 366, he Fe r l Cic t c l d t t t or na y m e ni of t cai t nns r uies the i r de a r ui oncude ha he di r a ng he l m e eq r s nne t vol t be s pa ae fom t outrvol ' I ume o e r t r he e ume. d. ' The Fe r l Cicui f t c l de a r t urher oncuded t t t çlc of overa ' bewee t t ha he ûa k lp' t n he wo s t he e r men ha he ume e rt ' M akus gr 8i t cli t upporst r quie tt tt vol s be s pa a e.' Waton r h oups n he am d s I 78 F. a 1 ( L 7 3d t 367 empha i adde . ss d) l a ton, t Fede a Cic t f n ddii he r l r ui ound t t t de c i to of t i nton i t ha he s rp i n he nve i n he s ciia i alo pr de s pe fc ton s ovi s uppor f ishol ng t tt m arcesbe s par t . Waton I 787 t or t di ha he ti e ae s L F. a 1 3d t 367. The Fe r l Cic t e ai d t t e de a r ui xpl ne hat he xampl i t 1 20 Paent de c i es n he 7 t s rbe i s r t lpophii m a rx gr nul s'c ç cee i di lc ti a e ' ompr s wih t hydr lc m arx. I Thus t es ed t he ophii ti d , he i s r t 'gr nuls a e one e ç c ee' a e r di xampl ofa i r vol e t ti s taly s pa a e fom a out e n nne um ha s pa i l e r t r n er vol (..t e r r nulrs c ) I a 1 ume fe,he xtag a a pa e . d. t 367. The Fe r Cicui a s e ane t tt s is a i de c i s pa ae c postona de al r t lo xpl i d ha he pec tc ton s rbes e r t om ii l c r t itc . Waton I 787 F. a 1 ha acersi s s L 3d t 367. For a il ta i oft postona ' lpophii n lusr ton l com ii l' i lc c r c e itc ,t Fe a Cic t ct d t s ii a i whi h de c i s ts ha a t rsi s he der l r ui ie he pectc ton, c s rbe tome r it e t essanc o t pe ta i ofs ve due t t poora fniy t r aque tui .' 1 Addii l a he ner ton ol nt o he fi t owa ds ous l ds' d. tonaly, s de c i d a s rbe bove, t s cii ton des i s c he pe fcai crbe ompostonal hy ophii c r c e itcs a ii dr lc ha a t rsi s ie r a l ice s l)vic st i sd t h d ae ly r' t h g vs o iys le ly r' s mak by n r a ed s o i n ie he y r td a e 'or û ih ic st woln a e .' r y a ' (7 Paenta c . 1. 126)i a c . 161. Theeor t Fe r Cic tssae ntt t $20 t t ol1 12 - d. t ol2 . ) rf e, he deal rui' ttme ha t ine lpophii m arx l a he n r i lc ti t nnotha hydr phii pr ri ' m e nst ti ca c ve o lc ope tes' a ha t nnote bi t xhi t he cha a t rsi sde c i i t pa e tasS dr phii ' WatonI 787 F. a 1 r c e itc s rbed n he t n t o lc. hy ' s L 3d t 367. I a ton, heFe a Cic te ane t tca m consr tonst tc d e m pa sa n ddii t der l r ui xpli d ha li tuci ha oul nco s sngl m arx sr t e oflpophii a hydr phii excpi nt woul be t br d. Waton I, i e ti tucur i lc nd o lc i e s d oo oa s 1 787 F. d a 1 3 t 36768. The Fe a Ci c t obs r t ' ny a bir r l s l c e vol e i a der l r ui e ved hat ç a r ta iy e e t d um n 8d M a k h g oup lsss ciid at m a i i apa e c am , t pialy i t f r :am e r 1 A r us r it pe fe le tves n t nt l i y c l n he o m mbe slced fom t goup co itng ofA,B,a C. Waton 1,78 F. a 13 n. (ii ee t r he r nssi nd ' ' s 1 7 3d t 63 3 ctng GilteCo.v Enegi rHol n ,I ,405F. 1 1 ( d.Ci.2005) let . r ze digs nc. 3d 367, 372 Fe r ). sngl m i ma rx woul s tsy t dititcour' c tuc i of lnne lpo lc ma rx' i e xed ti d aif he src ts onsr ton i r i phii ti be aus t tvol ewoul ne s arl c ai G tlas onelpophii e i e 'a i woul be c e ha um d ce s iy ont n a e t i lc xc pint nd t d Cns de't s r i i he ur oundi vol e. I a 1 . Agan,t Fe r lCic tr as ng um ' d t 367 ' i he de a r ui e oned t ta sn e ha igl sr t e c nnot s l e as bot a lpophii m arx and a hyd ophii mati . 1 The Feder l tuc ur a e' v h i lc ti r lc rx d. a Cic tc ude t tt cli f e r l ?m a rc wih a defned s i lr a i hi .' f r ui oncl d ha he a ms ' quie wt ties t r i pata eltons p ' #. a 1 (mpha i a d) t 368 e ss dde . e Cons r ton o di . t uc i f snner lpophii m at i ' and S er hydr i lc r x' ç out ophii m at i ' lc r x' on R em and Gove e by t Fede a Cicui' M a e on r mand, If e a lm ie t s On r nd, m d he r l r ts ndat e ac i t d a k. ema Imus f l t Fe r Cic tsM a t a t 1 w oft c e. Car acPac make s I .v t olow he de al r ui' ndae s he a he as di e r , nc . StJudeMed,I . 576 F. 1 1 ( Ci.2009)($ ma t r l rquiest tt . nc, 3d 348, 356 Fed. r t The ndae ue e r ha he dititc tf l a a la e de r as t l w oft c e.'. Hee,t FedealCic ts src our olow n ppelt c ee he a he as ' ) r he r rui' M a t sa e nda e t t s: ( ) rv re te d src c u tsc n tu to so tl rlp p ii W e e e s h itit o r' o sr cin f i me io h lc ma rx' a ti nd ' er hydr lc m arx, and is s e nt out ophii ti ' t ubs que i rnge e dee m i ton, a we r nd f r pr ee ngs nfi m nt tr na i nd ema o oc di c it ntwih t sopi on. onsse t hi ni Waton 1 a 13 s 1 t 68. Thus t ç oc di s'de c i d by t M a t r r m e t detr ne , he t ee ng ' s rbe pr he nda e equie o e mi wheher t W a s pr t c ans a ûnne lpophii m arx' and an toutr hydr lc t he t on oduc ont i n ' r i i lc ti ' i e ophii ma rx, consse wih t Fe a Cic tsOpi on. ti ' ' it nt t he der l r ui' ni Att 201 Tra ,Shie a gued t tt pr r c t u ton ofçi rlpophii ma rx' he 6 il r r ha he ope onsr c i 'nne i lc ti ' a i e hydr phii m a rx' a e a r ntfom t Fe r lCic ts Opi on. Specfc ly, nd t r out o lc ti ' r ppa e r he de a r ui' ni ii a l Shie co e r nt nds t t t Fe r Cicui s m pl i pos t o a tonal r quie e s on t ha he de al r t i y m ed w ddii e r m nt he pr vi c tu tons of çr e ous onsr c i i mer lpo lc ma rx' a t e hydr lc m arx': t t i i phii ti ' nd û r out ophii ti ' he wo ma rc m us e bi t i r s c i lpophii or hydr lc c r t itc , a t t o ties t xhi t he r e pe tve i lc ophii ha acersi s nd he w m a r c m us be s pa a e. ( 6Tra Tr Da 1a l 7- ShieOpe ng) t i es t e r t 201 il . y t 2: 20, r ni . l contas,W a s ur s m e t a n r t t on ge o dopta e iel ne c tuc i n ofi nne lpo lc n ntr y w onsr to l r i phii i m arx' a 'ou e hydr lc m arx. W a s a gue t t çlpophii m arx' m e ns a ti ' nd i t r ophii ti ' ' ton r s ha ûi lc ti ' a Sdipe son ofan a tve i e en wihi a c i t s ri c i ngr di t t n ontnuousphas ofwa e i ol e ma e ilwhi h e t r ns ubl t ra c f msalpophii sr c ur wih a aci i e e pa ked i o t i e si esoft tsnz t e.'' or i lc tu t e t n tve ngr dint c nt he nt r tc ha t cur ( 6 TralTr Da 1a 513- W as n Ope ng) Si lry,W as ar t tihydrphii 201 i . y t : 6, to ni . mial ton gues ha l o lc m arx' mea a 'd s son of a tve i e e a a s sc e l lr a ti ' ns çiper i c i ngr di nt nd uf i nty a ge mount of s lng weli hydr lc ma e i sknown ashydr l,whi , u comi i o c a twih lqui s l t ophii t ral oges ch pon ng nt ont c t i d we l o f m a mai ai a ge1lye ar und t dos ge f .' Ld.a 53:0- 4,W as Ope ng . or nd nt n a r o he a onu ' l t 1 1 ton ni ) W aton co e t tt s t c tu tons a e consse wih t or nar a c t a y s ntnds ha he e wo onsr c i r it nt t he di y nd usom r m e ni of i i a ng ' pophii mati ' a S ophii ma rx, a t t t e c tuc i ar l lc rx' nd t hydr lc ti ' nd ha hes onsr tons e ' c itntwiht Fe a Cic tsrquie nt.Ld.a 5 3- W as Ope ng) onsse t he derl rui' e rme s l t 2: 7, ton ni . Ia notc nc by W as sa g e t tt newl pr ed c t u o s ul m onvi ed t on' r um nt ha he y- opos onsr di ns ho d be a e For sa tr ,W a s di no a g on a doptd. tre s ton d t r ue ppea t t t 201 consr ons we e l ha he 3 tudi r i orec due t t i f l e t a c nc r t o her aiur o c ountf t pl i mea ng s tf t i isne c tu i . or he an ni e orh n t w onsr ctons Addii l W a s s c tu tons ar dif r nt t i pr e t t Fede al Cic t on tonaly, ton' onsr c i e fe e han t opos d o he r r ui a a. ( .ofDe sppe l Br f .Appela sa 35) On appe ,W as agued t t i r lpophii lnt t . al ton r hat he nne i lc m arx s d be co tue a ç lpo lc m arx t t i s pa a e a ditnc fo , and ti houl nsr d s $ i phii a ti ha s e r t nd si t r m c ai d w ihi a out r hydr lc m ati .' ( .of Desont ne t n, n e ophii rx ' Br f.Appelnt a 35 . Si lry, la s t ) mial W a s ar d t tt out rhydr lc m arx s d be c tu as $ hydr lc ma rx ton gue ha he e ophii ti houl onsr ed i a ophii ti t ti s pa a e and di tnc fom ,a e e na t , a i rl ha s e r t si t r nd xt r l o n nne i pophii marx.'(d ) lc ti ' 1 . 14 Not bl W a s n' c tu ton oft et nnson a alalgn- f t mos pa t wih a y, t o s onsr c i hes e ppe i or he t rt Shie' pr ed c tuctonson r nd;nn y, t l her s c i m a rce t r s opos onsr i ema mel hat k e pe tve ti s hems l sne d t e ve e t b çp phlc (.. v al o afnt twadsa u o sfuds)o çyd o hlc'(..h v o e l o ii' i ha e po r fi iy o r q e u l i ' r h r p ii, i a e i e e anç fniyt waerl' (d.at43) afi t o t '. 1 ' . I fnd t t t Fe r l Cic ts team e of t pr r c tuc i of t s tr s i ha he de a r ui' r t nt he ope onsr tons he e e m f e l esa new c tuc i . SeeEn lI s re , l .v fo ko me Co,1 6 F.d 1 7 or c os ny onsr tons ge ndu t is nc . cf r r . 6 3 3 9 ( e . r 1 9 )(ç is eta f lswihn t es o o t ej d me ta e ldfo b ti n t F d Ci. 9 9 1 s u h t al ti h c pe f h u g n pp ae r m u s o An r ie by t a la i isope ng bre i ne es arl wai d. Unls r ma d by t sco t as d he ppel nt n t ni if s c s iy ve e s e nde hi ur, a1is e wi ntes o eo t ea pe ldj dg n aed e di c mo ae wi nt ma d t 1 su s t h c p f h p ae u me t r e me n o r td t he n ae hi hi a dt u a ep e ld d fo f rh ra j d c to ' He e te rma d wa n ro a d f rt n h s r rcu e r m ute du iain. ). r, h e n s a r w, n o he pur e of deenni ng whe he W aton' AN DA Pr t m e s t Fe a Cic ts pos t ni t r s s oduc et he der l r ui' rquieme st t ( )t i rlpophii marx mus e bi lpophii c a trsi ,( t e r nt ha: 1 he nne i lc ti t xhi t i lc harceitcs 2) he outrhydr lcmati mus e bi hy ophii chaa trsi ,a ( t marc mus be e ophii rx t xhi t dr lc rce itcs nd 3) he ties t s eparat e. Ac or ngl ûnne lpophii m arx' a S erhydr lc m arx' a e consr e a c di y, t r i i lc ti ' nd i out ophii ti ' r tu d s f l s olow : C l m Ter ai m 2016 Cons r ton on R e and t uc i m l nnerlpophii m a rx' ' i i lc t i ' a m a r x i udi a l a t one lpophii e pi t w he e t ti ncl ng t e s i lc xci en , r he ma rx e bis lpophii cha acersi s a i l a ed wihi ti xhi t i lc r t itc nd s oc t t n, a s pa a efom,t out rhydr lc mati nd e r t r he e ophii rx S e hydr phii ma rx' a m arx ofa l s one h o lc excpi ,whe e t ma rx l r out o lc ti ' ti t ea t ydr phii i ent r he ti e bis hydr phii cha ac e i tcs a i l t d out i of and xhi t o lc r t r s i nd s oca e s de , s par t f om ,t i e ae r he nnerlpo lc m a r x. i phii t i On r m a I m us deer i wheher W a s s pr t s tsi t s a tona e nd, t t m ne t t on' oduc a ifes he e ddii l lmia i . i t tons I V. I r nav e nf i m ntAnal i vss - Ha ng deer ne t pr r co tuci of li r lpophii ma rx' a d e vi t mi d he ope nsr ton tnne i lc ti ' nd ç r out hydr phii m arx, l mus no de e mi as a m at r off ct whe he Shie ha pr n t t o lc ti ' ' t w t r ne, te a , t r r s ove ha W a s spr thasa çi rlpophii m arx'and i e hydr phii mati ' ton' oduc n snne i lc ti ' ' r out o lc rx'when pr ry ope l c tu onsr ed. I dee ni whehe W a s s ANDA Pr tcon a ns a Qnne lpop lc ma rx' n t nni ng t r ton' oduc t i n û r i hii ti ' i a to e hyd ophii m arx, a Shie a g s Im us c i rwhehe t AN DA Pr thas nd tut r r lc ti ' s r r ue , ' t onsde t r he oduc : ( )t spaae marces ( a i rlpophii marx t te bislpophii c r deitc ; 1 wo e r t ti ; 2) n nne i lc ti ha xhi t i lc ha a rsis a ( a outrhydr lcmarxt te bishydr lcc r ceitcs nd 3) n e ophii ti ha xhi t ophii ha a trsi . a. U ndi t be Fi ngs ofFac s ur d ndi t Cli 1rq ie aSc o to ld rla eo a ph r c u ia c mp iinl c ntii a am e ur s t l nr le -ee s r l ama e tc l o osto l o anng s g a a t i r de ts a n -aiyi a i ' (7 0Pae ta c 1 1.-) Cli 1as rq ie n ci ng e in -mio s lc lc cd. 1 2 tn t o . 17 8 . am lo e u rs ve ' 6 a tv ig e in $n a a u to 8 t 9 % . (d a c 1 1.7 2 ) as n d e n td s u e cie n rd e t 1 n mo n f 0 o 5 ' 1 t o . 1 - 8 .W to o s o ip t i ' 6 2 t tis AN DA Pr ha t odud i a c r l r l s or pha m a e i lc poston i t f m ofa s ontoled-eea e al r c utca om ii n he or tblt( 3Or rat1 5 , chco anss-mi s iylca i asa aci i e e (d.a a e 201 de 3-1 ) whi nti a no-alc i cd n tve ngrdint 1 t 1 n.2) i a a 2 1 ,n n mountof8 95 bywei oft t alc 0- % ght he ot omposton. ( 325- ,J ntPrtil ii DE 1 oi era Stp.a !29) i ,t . Addii ly,lma t f l ng undit be tndi i my 201 Or r( 246) tonal de he olowi sur d s ngs n 3 de DE t ta e r l va t my consde a i ofwhehe W a s n' ANDA Pr ha r e e nt o i r ton t r to s oductco a nsan çnner nt i i i lpo lc ma rx'and S e hydr lcm arx'ast et r sar now de i g i phii ti ' ç r out ophii ti ' hos e m e fned: 1 M ag sum se r t i t gr nul f r s a m a r c c l . ne i t a a e n he a es o m c os opi aly hom oge ous s r t e i a1 ofis vol e. (d a 1 . ne t uc ur n l t um 1 t 6) Sodi um sa ch gl a e i t e r gr a vol tr ycolt n he xta anulr ume f m s a or ma r c c l ho oge c os opialy m noussnzt ei al isvol . (d a 23) t c ur n l t ume 1 t . 3. Ac i i r e mes lm i i dipe s d i bo h t ti rlpophii tve ng edint aa ne s s r e n t he t nne i lc m arx' a çou e hydr lc mati 'of W a s s AN DA Pr ti ' nd E t r ophii rx' t on' oduc . t Ld.a 24- . l t 26) 4. The m a i se r t l t i t g a esoft W a s ANDA gnesum t a a e ocaed n he r nul he t on Pr tsowst r e eofmes a ne.(d at22) oduc l he elas almi 1 . 5. The s um sa ch gl ol t l a e i t e r gr nulr s ce wil odi tr yc ae oc t d n he xta a a pa l afc t rl s ofmes a ne.(d.at18n. ) fe t he eea e almi 1 25 . b. I nnerLi pophii M at x and O ut Hydrophii M at i areSe at lc ri er lc rx par e As dic s a s us ed bove t Fe r Cic thel t tt co t di ofûi r lpophii , he de al r ui d ha he nsnl ons 'nne i lc ma rx' a çou e hydr lc mati 'r quie s pa a e ma rce . Wat on I ,787 F. a 1 ti ' nd i t r ophii rx' e r e r t ti s s 1 3d t 366. The Fe r l Cic t e aned t t ç he ma rce a e de de a r ui xpli ha ' t ti s r fned by mut l e l i s i ualy xc usve patal c r c e itc --one i r a ha a t rsis nne , nd o ne outr a e nd mut ly e l i ua l xcusve co postona m ii l cha a t rsi s r c e itc --one hydr lc,one lpophii ' 1 . a 1 ophii i lc.' d t 366. The Fe r Cic tde crbe de al r ui s i d is ta c r cersi s'i tnns ofdif e vol ipa il ha a t itc ' n e fer nt umes l a 1 67 (t c n tu to o çn e . d t 3 she o sr cin f in r t lpophii m arx'r quie t ime vol i lc ti e r s he r r ume t be s pa a efom t out rvol e.' , eealo i o e r t r he e um '' )s s d (he Makus goup t upporst r quie ntt tt vol t r h r ' s t he e rme ha he umesbe s paae'. The Fedeal e rt') r Cic tde c i i r ui s rbed t compostona c r t rsi s'i tnus oft cha acersis oft ma rc ii l ha ac e itc ' n e he r t itc he ties 9Addii lr lva fndi off c t t i rnge e tde e na i we e m a i t 201 tona ee nt i ngs a t o he nfi m n t nni ton r de n he 3 Or r a rmant 1 oft ca e.( 3Or r. de , nd e i he aw he s 201 de) d crbe by t pa e . See as i.(%q e s e iiain e pli s t a a l o hii marx es i d he t nt lo d sth p cfc to x an h t i p lc ti l p l oppos s s e ome r it nce t t pe ta in of t s ve due t t poor a tniy t r essa o he ne r to he ol nt o he fi t owa ds a ousfui '' que l ds') For t r s dic s d bel t W a s ANDA Pr he ea ons s us e ow, he ton oduc cont ns a s tal a t ai pai ly nd c ompostona l s par t i ii ly e a e nnerlpophii ma rx and ou e hyd o lcm arx. i lc ti t r r phii ti i Spataly Separ e . il at 1prvi l f t W as sANDA Pr tc anst vol :( )grnuls a e ousy ound hat ton' oduc onti wo umes 1 a e , nd ( t s c outi oft ga es(heçe r grnulrs e'. ( 3 Or ra 1 1 1 a 2) he pa e sde he rnul t çxta a a pac ') 201 de t 6-7, 8 t n. 23 . Iba e t sfndi on e de fo Dr Buga who c 25, ) s d hi ng vi nce r m . y, ondude Sc nni Elcr n d a ng e to M i osopy (1 ' a Enegy Dipesve X- ai (t ' a ysson t uncoaed, cr c tSEM') nd r s ri Raditon : EDX' nal i ) he t c r tbesu e i W a s n' ANDA Pr d c. (d a 1 P 42 S o e a lt s d n to s o u t 1 t 6; TX , EM EDX I g s. las ma e ) lo c i r W a s s m a acurng pr ce s whi h r uls i compr s t e s m a up of onsde ed ton' nuf t i o s , c es t n es ed ablt de g a ulra d e ta r n lrrgo .( 01 Or e a 1 - 2 . r n a n xr g a u a e ins 2 3 d r t 1 1 ) Att 2016 Tra ,Dr St ve Litet tted t tDr Buga s i a de c e i ra he i l . e n tl esis ha . y' m ges pit d nne nd outrvol est twer s ta l s pa a e û e um ha e pai ly e r t : i c n s dic e e r ons t ta e g a e he e You a ee s r t egi ha r r nul s r t t a e dif e t a s r t fom t extag a ar s c ha r fer nt han nd epa a e r he r r nul pa e . s t o hey a e s ta l r pa i ly spa ae. ( 6 TralTr Da 1 a 73: 9;s alo i 72: - 9,83: 1 Lite Die t. e r t ' 201 i . y t 5- ee s d. 2173: ' 6- 4, tl rc) Si iary,Dr Parc Si t tfed t tt i mll . tik nko esii ha he mage s s how t gr esand e r a a s c he anul xtagr nulr pa e k e s tal spaae s t y ae physc l spaae , û paily e rt, o he r ar ialy e rt .'(d at230:- Si Diec) '1 8 9, nko r t. Addii nal W as s e r,Dr Pa k, a knowl dge t W atons s ANDA Pr t was to ly, ton' xpe t . r c e d hat s ' oduc di de i o grnul and e r grnulrvol . ( 6 Tra Tr Day2 at283: 239:8,Pak vi d nt a ar xta a a umes 201 il . 25- 1 r Cr s. os) 18 Addii l Shie pr ent e de e fom Dr Ya t t f t r s tonaly, r es ed vi nc r . ng ha urhe hows W a s s ton' A N DA Pr oduc c a ns t o s pa a e vol es ( 6 TralTr Day 1a 1 720) Dr Ya t ont i w e r t um . 201 i . t 52:- . . ng ton a e , nd xa ne he r s s c i d ura m ir om e 1 a w a s AN DA t bl t a e m i d t c os -e tone s f cew ih a op i l c ot d 0 t n tca m ir co . Dr Ya obs r d t s i l s par t sr t e , whi h he i tfe astrype c os pe . ng e ve wo pataly e ae tucur s c den ii d é 1'a lType 2. d-ype 1'sr c ur we e g r ly ova orcic a i s pe and ha adar r ' nd ' ' t' i ' tu t es r ene al l r ul r n ha d ke col i orng. Sl t - 2' s r t e w er ge r l be wee t ç l -ype ' tuc ur s e ne aly t n he t- ype 1' s r ' t udur s a w e e e nd r ir gulry s ped wih lght c orng. (d a 1 9- 5; 1 25- 48: ) Dr Si ltr re al ha t i er ol i I t 44: 1 47: 1 21 . . nko ae t sii t t t tlype 1'a V-ype 2'sr t e wer t tgr nul ' a Se r gr nulr' e tfed ha he k' nd tf ' tuc ur s e he k a ar' nd txta- a a ' rgo s r s e t ey.Se i. t 7:0 21 :6($Dr Ya g c le t e tpeo ea d tp t . e in , e p ci l e d a 21 1 - 8 1 ç . n ) ald h m y n n y t wo v ( . It c l r e g t t A ( lg a a a e r -r nulr Butbascal i i t s ypialy efr) o hen as r nulr nd xtag a a. i ly, t s he ame t1ré.'. li1j' ) Ac or ngl Shie' pr ed i rlpo lcand out hydr lcm arc a ede i c di y, r s opos nne i phii er ophii ti es r fned by mut l e l i s ta c a t rsis a t vol e ma ng up t im e lpophii ualy xcusve pai l har c e itc , s he um ki he l r i lc ma rx- t i e i oft gr nul i s ta l s pa a e fom t vol e m a ng up t out x ti he ntror he a es s pa ily e r t r he um ki he e hydr phii m ati t e r gr nul r s ce o lc rx he xta a a pa . i. Exhi tSe at C har t i tcs i bi par e ac er s i Imus ne c i rwhe he t s ta l s pa a e vol t xt onsde t r he pa ily e r t umes t i rgr nul a t - he nne a es nd he e r gr nul rs e exhi ts pa a e c r ctrsi s Evi nc pr e ed a tils xta a a pac bi e r t ha a e i tc . de e es nt t ra howst tt ha he s pa a e i r a out r vol s c an dif r nt diti i of e pi s t r ul i e r t nne nd e ume ont i f e e srbutons xci ent hat es t n s pa a e cha acersi . Thi s pa a e d srbuton of e pint ac unt f r t s pa a e e rt r t itcs s e r t iti i xci e s eo s o he e r t c rceite ( .lpophii a hydr lc)e biedby e hoft marc . haa trsis Le i le nd ophii xhi t ac he ties 1 A m ir ome i a a 0 c ot s n dvanc d c tng i t um e , whi h Dr Ya us d t ob a n a ve y s oo h e uti ns r nt c . ng e o t i r m t s fc upon whih he c ura e, c onduce a dr pe tai t t ( 6 Tra Tr Day 1at1 2td op nerton es. 201 il . 44: 8, Ya Die t. ng r c) 1 pr vi l f nd t hydr phii s um sa c gl olt exit i cuser or e ousy ou he o lc odi t r h yc a e ss n l t s a eg t s i c tng hi r c ggr a e , ndia i ghe once r ton, i t e r gr a s ces of W at on' AN D A nta i n he xt a anul r pa s s tona l e tblt asco r d t t grnulrs c . ( 3 Or ra 23) Addii ly,bas d on Dr. a e, mpa e o he a a pa es 201 de t . Buga s SEM / y' EDX i a s Dr Si t si d t tt r a e no agg egae of s um sa c m ge , . nko e tse ha he e r r ts odi tr h gl olt i i t gr e.( 6 Tra Tr Da 2 a 75:8- 1,Si Re rc) Dr Si yc ae nsde he anul 201 il . y t 1 76: nko die t. . nko t tfe t ts um sa ch gl a ei m or ç e t n t m a se r e outi 'and t Si' esii d ha odi tr ycolt s e s nt ha he g t a at pot sde' hat çts s rt bec us i ovewhems t be or of t ma se ae.' ( 6 TralTr Da 1 epaae a e t r l he havi he g tart ' 201 i . y a 224: 21 Si Diec) t 3- , nko r t. Aslpr vi l f e ousy ound,t m a i se r t woul i pa tr l e i t gr nuls but he gnesum t a ae d m c eeas n he a e , n ti t ee ta r n lrs c .( 01 Or e a 1 n. 5 .Fu te , f u dt a, i t es du o n h x r ga ua pa e 2 3 d r t 8 2 ) rh r 1 o n h t whl h o im e sa c gl a e out i oft gr nuls woul afe tr e e ofm e a a i t s um sa c t r h ycolt sde he a e d f c elas s l m ne, he odi tr h gl olt wihi t grnuls wo d not afctt r e e. (d.. Thi difr il i t yc ae t n he a e ul fe he elas 1 ) s feenta n he diti i ofe pi t r s t i t s pa at vol e t te bi s par t c r trsi :t srbuton xci en s e uls n wo e r e um s ha xhi t e a e ha ace itcs he gr nuls e bi lpophii c r t itcs whe e t extag a arr ons exhi thydr lc a e xhi t i lc ha acersi r as he r r nul egi bi ophii c a trsis (d.a 72:6- 24,LiteDiec;i a 228: 230:6,Si Die t. harceitc . 1 t 1 73: tl r t d. t 20- 1 nko rc) Addii na l Dr Lite t sii d a t 201 Tralt t he o er d t vol to ly, . tl e tfe t he 6 i ha bs ve wo umes t t ha e bi t s pa a e c r c e itc durng hi dis uton sudi s of t W a s ANDA xhi t wo e r t ha a t rsi s i s s ol i t e he ton he t on ablt n o we l r Pr uct1 Fis,t ou e r gi of t W a s ANDA t e bega t s l, e ode,a od .1 r t he t r e ons nd dii egat ( 6 TralTr Da 1 a 8 20- 1 Lite Diec) As t s occ r i ac snt r e. 201 i . y t 2: 83:4, tl r t. hi ured, nt t g a e wer rl s d. (d) .Litee ane t tt s lng,eoson,a dii e ai r nuls e eea e I .Dr tl xpli d ha he weli r i nd sntgrtng beha or of t extag a ar r ons i d t t out r hydr lc m a r x of s um sar h vi he r r nul egi s ue o he e ophii ti odi t c gl olt (d a 82:0-1 ) l c rs,t grnuls t t wee r ea e t oughout t yc ae. 1 t 1 5 . n ontat he a e ha r el s d hr he l I a e s d Dr Lit e s e l ddr s e tl ' xperm e al m e hod i m y 201 Or , and t e t ndi w e e i nt t n 3 der . hos i ngs r undit bedona al ( 246a 1 1 . sur ppe . DE t 4- 5) 20 dis uton obs l ton di no s l buti t ad pe ssed i t bufer Dr Liteexpl i d t t s ol i ewa i d t wel, nse r it n he f . . tl ane ha t per it nc oft gr esi due t t magne i se r t wihi t i e vol he sse e he anul s o he sum t a a e t n he l r ume oft m he g a ue . (d a 8 1 - 7:0 .Dr Li l tsi d t tthet dfe e tb h vir ta we s e rn ls 1 . t 6:6 8 2 ) . t e etse ha ' wo ifr n e a o s h t e t t a edif e , he ar s pa ae. So yo s ahydr lcbe vi r a t n wha i i i i yo r fer nt t y e e r t u ee ophii ha o , nd he t s nsde s u s t egr nul t tar e bii lpophii be vi .'(#.a 8 20- 11. ee hes a es ha e xhi tng i lc ha or' f t 2: 85: ) Dr Ya . ng alo pr en e e rme al e de e of t s es t d xpe i nt vi nc wo vol es e bii um xhi tng c ompostonaly s par t m arc s Dr Ya pe f med a wae pe taton t t t a s s ii l e a e ti e . . ng ror tr ner i es o s es whehert W a s ANDA Pr tc aned s pa ae vol t he ton oduc ont i e rt umest e bi dif r ntc pactes hat xhi t fe e a ii t r ss t ep n tain o wae .(d a 1 0 1 - 41 1 , n Die t.A d o p ner to ts i o e it h e erto f tr 1 . t 4 :4 1 :2 Ya g rc) r p e ta in e t s a r i t tus d t sudy t i e aci ns be wee s i a lqui . (d.a 1 6- 2,Ya outne es e o t he nt r to t n old nd i d I t 41: 1 ng Diec;se alo 201 Tra Tr Da 1 a 21 17- ,Si Diec ( op pe tai t ti a r t e s 6 il . y t 8: 21 nko r t dr ner ton es s sa r c r t iaton t r ogni dbyphama utc li tyl. tnda d haacerz i ool ec ze r ce ia ndusr ) Asdes rbe above,Dr Yang m ir o ed a tbl t wihi whi h he i ntfe t n Sr ci d . c ot m a e, t n c de ii d e ç ype - 1' n tnll p 2'o ain .( 01 Tra Tr Da 1a 1 :5 1 9:9 Ya Die t.Th n, . 'a d e s- e 'lc to s 2 6 il . y t 472 - 4 1 , ng rc) e Dr -y Ya us d a m ir oni t rt plc pi olt r sz d d o of d sil wa e o ea h t of ng e c og ome e o a e c ie -i e r ps itled t r n c ype sr t e.(d.a 15 : 1 1 2: 1 1: 7) tucur I t 0 1 - 5 2, 6 6- .Themir omeermea urd t pe tai r t of cogoni t s e he nerton ae ted o sd po ie o tetl p 1' n i p 2' e in . (d a 1 5 1 - 5 4 . Ona ea e h r p e std n h t- e 'a d ' e 'r go s 1 . t 5 : 0 1 6:) -y Ty v rg , t Sly 1'gr nul s exhi t d a wae pe ta i r e t t wa 6. tme sower t n t he l-pe ' a e bie tr ne r ton at ha s 8-i s l ha he t y e 2'e ta rnua r go s (d a 1 24 1 4:5 PTX 51 a 8 . Thu ,Dr Ya g s ' P ' xr ga lr e i n . 1 . t 5 :- 5 1 ; T 2 t ) s . n' e rme a da a as s xpe i nt l t lo hows t t t tr ha he d ype - a t nd ' Type 2' sr t e e bi s pa a e ' tuc ur s xhi t e r t com posii tonalchar eri i r di af i t f w at . act stcs egar ng fniy or er Ac di y,1fnd t tt i ne vol e oft gr nul a t e r gr nulrvol e cor ngl i ha he n r um he a es nd he xta a a um whih m a up t vol e ofShie' pr pos d ti rlpophii m arx' a to e hydr lc c ke he um r s o e lnne i lc ti ' nd tut r ophii m arx, r s c i l -- xhi tco postonal s pa a ec r de itcs ti ' e pe tve y -e bi m ii ly e r t ha a rsi . ' c l rLi . nne pophii M at i Exhi t Li phii Char t itc lc rx bis po lc ac er si s I mus nextdet mi whehe t W a s ANDA Pr tcont ns a i r lpophii t er ne t r he t on oduc ai n nne i lc marx t te bislpophii c r t rsi s Asdes i d a ti ha xhi t i lc ha ac e itc . crbe bove t Fede alCicui e aned r r t xpli , he t tt ' Pae d c i d t i ha he 720 t nt es rbe s pophii pr ri s'a l ome r ss a et t pe r to oft l lc ope te ' s s s e itnc o he neta i n he s ve due t t poora fniy t r a ous tui .' (720Pae atc . 1.7- Waton ol nt o he fi t owa ds que l ds ' 1 tnt oll 11 20; s 1,7b F.d a 1 6 ) Ad i o al ,t Pa t ssiu ae t a c n tu o o iio hi c' h t I 7 3 t 3 5 . dt n ly he ri tp lt o o sr di n f ûp p l 't a i e l i me nsd vi apoora tniy t r a ousfui . ( 3 Or a 6) a t ng ha fi t owad que l ds' 201 der t .The 1 Paentas ' 720 t lo de ci t tt ine lpophii marxsowst r e eofme aami (720Paentcol411 s rbes ha he n r i lc ti l he elas s l ne. $ t . .5 . The i r t r or i whet rt imervol oft gr es whih i t vol ) nquiy, heef e, s he he l ume he anul c s he ume t tmeest i epa a e'r quieme e bist e lpophii c a t rsi s ha t he é r t ' e r nt xhi t hes i s lc har c e itc . M y undit be fndi off ts sur d ngs ac uppo tt tt diti i o m ag sum se r t i t r ha he srbuton f ne i t a ae n he vol oft g a ese t r it nc t t pe tai ofs ve .Fis ,i i undiput t t ume he r nul xers ess a e o he ne r ton ol nt rt t s s ed ha ma i se ae i alpophii s tnc 2013Or rat1 n. 1 n.9) Addii ly,1 gnesum tart s i lc ubsa e.( de 2 9, 6 1 . tonal pr vi l f e ousy ound t t ç a sum se r t l t d i t gr nul s wilha a e f ton t ha ' gne i m t a a e oca e n he a e l ve n fec he r e s ofmealmi ' (d a 18n. s alo ff a 22 n. ) Furhe mor If ela e s a ne. 1 t ' 25; ee s t t 31. t r e, ound t tt ha he ef c o r la eb ma ne im se rt wa ln e t islp p ii c r ce itc :tma ne im fe t n ee s y g su taae s ik d o t io h l haa trsis l g su c g se rt i)k o t p ro m te f n to o so n d u r la e b vit o gt)lp p ii taae s n wn o ef r h u cin f lwig r g ee s y rue f is io hlc naur ' (d a 22) l f t t o y wa t tmag sum seaaecontol r las i duet is t e. I t . n ac, he nl y ha ' ne i t rt r s ee e s ot l o hlcc rceitc .( 01 Tra Tr Da 1a 21 :9 21 5 Sik Die t. i p ii haa trsis 2 6 il . y t 5 1 - 6:, n o r c) p Furhe mor t tm o t r e, esi ny s howe t t m ag i d ha nesum se ae may i tar t mpar lpophii t i lc c r trsi t a composton e i l conc nta i . Dr Si t tfed t tt r l ha ace itcs o ii ven n ow e r tons . nko esii ha t y ow ve c n e tain (fma ne im se rt)h v b e k o t h v sg iia te fcso tbe o c n rto s o g su taae a e e n n wn o a e in fc n fe t n a lt f multons' (d.a 208: 209:) Dr Si dic s s intfcltrt er c zng t t or ai .' 1 t 23- 8 . . nko s used ce ii ieaur e ognii ha tui c eey f ld t pe taeablnd c ani 5% ma i se rt (d a 209:2l d ompltl aie o nert e onti ng gnesum taae. 1 t 1 22,21 25- 124) Dr Si alo dicused r ee s whee a c ntai of 0. 0: 21 : . . nko s s s efrnce r once rton 5% m a sum sea a e wo d ha ç pr ty sgni an e f ti r sng t tcompl t dis u i gne i t r t ul ve f e t i sc t fec nc ea i ha a ee s olton tme by ...eiht tn,pl f d. (d.a 211: 21 1 . Defnda ' e r Dr Pak as i g , e us ol ' 1 t 25- 3:7) ' e nts xpe t . r lo ac knowl dge t t' i lpophii i ar s t tmag sum se r em a r t r t r l a e .. e d ha k ng i be lc s ea on ha ne i t a at y e a d he e e s ( 6Tra Tr Da 2a 1 22- PakCr s. 201 il . y t 97: 25, r os) Addii nal Dr Ya s e i t lt tng confr st tt gr es e bi a poor to ly, . ng' xpermen a esi im ha he anul xhi t afi t f aque fui . Asdes rbe above Dr Ya f fniy or ous l ds ci d , . ng oundt tt abs pton r t ofwa e ha he or i ae tr was6. tme sowe i ot Ty 1sr cur (hegrnuls compard t t a optonr eof 8 i s l r nt he pe tu t e t a e ) e o he bs i at wae i ot Ty 2 sr cur (he e r r ul rgi .( 6TralTr Day 1a 1 1 1 tr nt he pe tu t e t xtagan ar e on) 201 i . t 54:2- 5, 1 1 1 1 1 1 2,Ya Died;i a 21 8-4,21 11 1 Si Die . 55:2- 8, 56:7- 57: ng r d. t 4: 1 9: - 7, nko rd) Alho h m ag i sea a e i pr e wih ot r e i e s i i of t g a e t ug nesum t r t s es nt t he xc pint nsde he r nuls ciialy,povi pe fc l done,copovi done,a mi oc ysali c l os t e ot e pi nt a e nd cr r t lne elul e hos her xci e s r notr pons bl f t lpophii c a t r s i s obs v d i t gr nul s. D urng t fr tt i l es i e or he i lc har c e i tc er e n he a e i he i s r a , Shie pr s nt t t s i ony ofW at on' e r e e ed he e tm s s xper Dr Leo Tr no,who pe f m ed a di s uton t . evi r or s ol i t ton W as smild grnuls ( 3Or r a 22 n. 2013 TralTr Day 3 a 205: es ton' le a e . 201 de t 31; i . t 20207:3,Si Die t.The egrnulsc ane mes a nea t s mee i e s( done 1 nko rc) s a e onti d almi nd he n xcpint povi , c opovi done,a mir ysalne cel os ) a t grnuls i t fna compr sd W as nd cocr tli lul e s he a e n he i l ese ton ANDA Pr oduc . Howeve ,t gr nuls Dr Tr no t t d l ke m a i sea a e a t r he a e . evi ese ac d gnesum t r t nd s u sa c gl olt 1 a 1 7- 1: Trvi Die t i a 206. 207: Si Diec) l odim tr h yc ae.(d. t 0: 1 3, e no rc; d. t . 6- 4, nko r t. n t abs e ofm a sum sea ae and s um sar h gl ol e, Dr Tr vi st s s he enc gne i t r t odi t c yc at . e no' e t howed ne r ai e a e r e s o m e aa i f o t mil d gr nul . (d.a 207: 1 Si Die t. mm dit ela e f s lm ne r m he le a es 1 t 5- 3, nko rc) Si ia l D r Lite pe f m e a dis uton e i e wih pur mes l nea obs r e t t m lry, . tl r or d s ol i xperm nt t e a ami nd e v d ha t m e alm i dis ve wihi s ondst m i es ( 6 Tra Tr Da 1a 8 1 22,86: he s a ne s ol d t n ec o nut . 201 il . y t 4:83- 1 Lite Die t s e alo 201 Or r a 1 15) Gi n t s rs t,Dr.Lite a Si 5, tl rc; e s 3 de t 4- . ve he e e uls s tl nd nko c l d t ts hi i t W as grnulsbesde t i rgr are pi t ( done oncude ha omet ng n he ton a e i s he nta anul xci ens povi , c po do ,a mir r t lnec l os )wa sowi t r e e oft me aa ne. ( 3 o vi ne nd c ocysali elul e s l ng he elas he s lmi 201 Or ra 1 201 TralTr Da 2 a 39: 40: , Lite Cr s 201 TralTr Da 1 a 86: 6de t 5; 3 i . y t 22- 2 tl os ; 6 i . y t 1 8 205 tl Diec;i a 21 1 24521 1 21 9,Si Die t.z 7: Lite r t d. t 4:56:9- 7: nko r cll Dr Lite' dis uton e rment-dicus e above a i t 201 Or r as . tl s s ol i xpe i - s s d nd n he 3 de lo pr de e de e t tt i ovi s vi nc ha he nnervol e oft W as ANDA Pr um he ton oduc e bisr it nc t t t xhi t essa e o he pe tai ofs ven . ( nerton ol t 2013 Or ra 1 15;201 Tra Tr Da 1a 86:2-1 LiteDie t. de t 46 il . y t 1 5, tl rc) Dr Lite t sii d t tt gr nul s r l as d fom t W a s ANDA Pr . tl e tte ha he a e e e e r he t on oductdi nots l d we l t , t y di not e bi hydr lc c r c e itcs as t woul i t s um sa c hus he d xhi t ophii ha a t rsi hey d f he odi trh gl olt i t grnulsha a ef t(d.a 8 23- 1 85: 11,LiteDie 2013Or ra yc ae n he a e d ny fec.1 t 2: 83:4, 8tl rd; de t 1 n. . Rahe,t ganulsrssedt pe r in oft a ousbufera pe sse f as 5 25) t r he r e e it he netato he que f nd ritd or l a 8 mi e .( 3 Or a a 15;201 TralTr Day 1a 8 1 7,8 1 1 87:6ong s 6 nuts 201 der t t 6 i . t 4:3-1 6:2- 5, 1 20, Li l Die t i.a 21 1 -4,21 1 - 79 Sik Die t. Ba e o t e hih s lbit o t e rc ; d t 4: 52 t 6:7 21 :, n o r c) s d n h g ou l y f i mes lm i a Dr Tr no' t ts wi t tt ot rh ophii i e e sha no e f c aa ne nd . evi s es ho ng ha he he ydr lc ngr dint d fe t 1 Thi e de alo s 2 s vi nce s uppors t t t ot exc pint ,besde m a i s gnesum sea a e i t i t r t , n he t ha he her i e s g anuls a e f tonal urr aed t t lpophii m arx. Thi i dic s d i m o e de ali r e r unci ly lelt o he i lc ti s s s us e n r t i n Se ton I .e. ci V o r e e, Dr Lite co l n elas . tl ncuded t t m a ha gnesum sea a e i r ponsbl f r t gr e i t r t s es i e o he anuls' r itncet dis uton.(d at83:5- 9,86:6- 20,LiteDie t. essa o sol i 1 1 1 1 87: tl rc) l r s ns t t se de ,W a s a guest tt r i note ugh lpophii s t nc n e po e o hi vi nce ton r ha he e s no i lc ubsa e i t i n he nnervol e oft g a e t pr um he r nuls o oduc lpophii c r c e itc W as r i s o Dr e i lc ha a t rsis. ton ele n . Par st tm ony f s k' esi or uppor, t who f ound t tt tt a ha ha he mountofm a sum sea a eSi s s a l gne i t r t ts o m l, youc te bi lpo lcprpet ba e ons h as l a t . ( 6 Tra Tr Da 2at anno xhi t i phii o ry s d uc mal momt' 201 il . y ' 1 1 21 Pak Die ) Howe r Dr Pak di notct any e rme sorsudi t c im 57:7- , r rct. ve, . r d ie xpei nt t es o onfr hi opi on. l ed,hi o ni wasc r di t by Shie' e r Dr Si s ni nde s pi on onta ced r s xpe t . nko,who t sii d t t e tte ha iheprmay is i ...t potnc oft c c . ( 6 Tra Tr Da 1a 209:- Si t i r sue s t he e y he hemial' 201 il . y t 14, nko ' Die t. Dr Si tsiid t ti wa welrc) . nko e tfe ha t s lknown i t s intfc ltrt et t1 lvel of n he ce ii ieaur ha ow e s mag sum se ae c d pr e make lpophii efcs (d a 209: 8,209:2- 1: ne i tart oul oduc r d i lc fe t. 1 t 51 21 24, 21125- 3:7,Si Die t s e al i a 99: 8,Lite Cr s (esiyi t tma i : 21 1 nko rc; e so d t 3- tl os t tf ng ha gnesum sea a e C s one of t mos lpophii t ngs I c n i ne, s fom a c mi al sr c ur t rt l i he t i lc hi a magi o r he c tu t e sa t ndpoi ,fom how i r it pe tai n ofwa t ,i ha be n s wn i . pe c ntbe or t nt r t esss ner to t r t s e ho n 5 re f e o ca e r e e i bii glfdslke t t rssi pe tai ofwae ...). Addii ly, us elas nhi tng efe i ha, e itng nerton tr ' ) ' tonal s h lt r t e i c it ntwih t : 20 Pae is l,whih dicl e gr nuls c ani onl uc ie aur s onsse t he 7 tnt te f c s os s a e ont i ng y 2. lpop lcs tnce bywei .(7 Pae ,c .5l. 45 . 4% i hii ubsa s ght $20 tnt ol l30- ) I a sm ia a g e ,W a s c e t tt lpophii orhydr lc s t ncem us n i lr r um nt ton ontnds ha he i lc ophii ubsa t c tt e t t an c onsiut he d i ompo nt'of t r s tve lpophii o hydr lc m arx,a t t m ne ' he e pec i i lc r ophii ti nd ha S nc ç mai ompone ' s d be unde sood qua iai l ( 6 TralTr Day 1 a 42: nt' houl rt ntttvey. 201 i . t 2123, W as Openi s eal 201 TralTr Day2 a 1 1 25,Pak Die t. l s ton ng; e so 6 i . t 26:9r rc) n uppor,W as t ton l ookst a pa s e f om t Fe r lCicui c tng t po ton oft s c f c ton des i ng i t o s ag r he de a r t ii he r i he pe i i a i crbi ner m arc s whe e khe m a n compone oft mati sr c ur 'oppos s s ti e r l t i nt he rx tu t e' e ome r it nce t t essa o he pe rton oft s vent Waton 1,787 F. at1 66 ( tng $ Paen,c .11.7- . netai he ol . s 1 3d 365- cii 720 t t ol 11 20) Howeve ,t Fe a Cic tct d t s pa s ge t s r he der l r ui ie hi s a o uppor is hol ng t t t m a rx e bi tt di ha he ti xhi t lpophii pr ri no ne s a iy t s i lc ope tes t ce s rl o uppor a hol ng t t lpophii s t nc mus be t di ha i lc ubsa es t pr e i ace t n qua ia i a es nt n rai ntt tve moun . t To t c r r t Fe r Cic t onl hed t t t i r lpophii mati mus he onta y, he de al r ui y l ha he nne i lc rx t e bi lpophii c r c e itc a bes par t fom t outrhydr lc m arx. Defni t xhi t i lc ha a t rsis nd e ae r he e ophii ti i ng he cli sa or ng t s cii pe c nt gesofi vi li r di nt woul co r vene t Fe a am cc di o pe fc r e a ndi dua ng e e s d nta he der l Cic ts e r ui' mphass on t c r t rsi s of t mati e t m s ves as o i he ha ac e itc he rc s he el , ppos d t t e o he c rceitc ofte e cpe t. Se Was n I 7 7 F.d a 1 65 6 (-h ,a Cio h l haa trsis h x i in s e to L b 3 t 3 - 6 lr us l p ii t p c marx i mo et a j tamarx wi a lato e l o h lce cpin t marx is l mus ti' s r h n us ti t t e s n i p ii x i e t he ti tef t h p exhi tlpophii c r t itcs') bi i lc haacersi . . ' 1 fnd t tmag sum se r e i t ' an c pone ' oft i r lpophii m arx. i ha ne i t a at s he t i om m nt' he nne i lc ti Ac or ng t bot Dr .Sil a Lite,t t ai c c di o h s rko nd tl he d n ompone ' i t snzt e r ponsbl f r m nt' s he t c ur es i e o t lpophii o hydr lcbe vi . ( 6 TralTr Da 1a 76:6- 1 LiteDiec;201 he i lc r ophii ha or 201 i . y t 1 77:, tl r t 6 Tra Tr Da 2 a 1 4- 3,Sil Cr s. Thequa iy ofa c il . y t 2: 1 rko os) ntt ompone al i notar ibl nt one s ela e i c t oft c r t itc oft e iec ndiaor he haacersis he ntr omposto Se 201 Tra Tr Day2 a 1 9- 3, iin.( e 6 il . t 2: 1 Si Cr s t s y i quan ia i l t m e,lute l di a ee ...Iw oul s i ha not ng t nko os : ' a t To tt tve y o t ry s gr d ay t s hi o do srcl wih qua iy.) Bot Dr Si and Lite t tfed t ts e i e s s as tity t ntt ' . h . nkos ' tl esii ha ome xcpint, uch mag sum se ae,a e t en ' i t s ns t tl q ntte of i vi ne i tar t r ç pot t' n he e e ha ow ua ii s ndi dualc pone sca om nt n l d t sg fca lpophii c r trsis ( 6 Tra Tr Da 1 at208: 209: Si ea o inii nt i lc haaceitc . 201 il . y 23- 8, nko Die t i a 99: 8,Lite Cr s. Thus t S ai c pone ' oft i rlpo lc ma rx r c ; d t 3- tl os ) , he ç n om m nt' he nne i phii ti t m a s um s e r t -- xhi t t r r d lpophii c r c e i tcs he gne i t a a e bis he equie i lc ha a t r s i . 26 For t f e ng r as , 1 fnd t t t i eror vol e of t gr nul exhi t he or goi e ons i ha he nt i um he a es bis lpophii cha a e itcsand doe notexhi thydr lc cha a e itcs Thi i r vol e i i lc r ctrsi s bi ophii r ctrsi . s nne um s s r t fom t e outr vol epa ae r h e ume. Acc di y,t W a s ANDA Pr or ngl he ton oduc c ans a i t ont i n nner lpophii m a rx- t vol ewihi t gr nul whih exhi t lpophii cha acersi s i lc ti he um t n he a es c bis i lc r t itc . d. O ut r H ydr e ophii M at i E xhi t Hydr lc rx bis ophii Charac e i t c lc t rs i s l m us ne deer ne whe he t W a s AN DA Pr uc alo c ai a out r t xt t mi t r he t on od t s ont ns n e hyd o lc m arx t exhi t hyd o lc cha a e itc . r phii ti hat bis r phii r ctrsi s As des i d a crbe bove, t he s e iiain d srbe ûy r p ii c aa trsis's c a çe r a l ice s lq vs o i p cfc to e ci s' d o h l h rce it ' u h s ç mak b y n r a ed ic st h c c r y i i t hydr e l er'Ort hi vic iys lnlye . (720 Pae c . 1. 126;i a nsde he atd ay ' 1 gh s ost wole a r' 1 a ' tnt ol1 12 - d t c . 1. 64) Addii ly,t Pate hav si atd t ti ophii' me ns t ng a o12 160- . tonal he ris e tpul e ha l hydr lc' a d havi n a fniy t wae . ( 3 Or a 6) Hee,t vol of t hydr lc marx t fi t o tr' 201 der t . r he ume he ' ophii ti he e r gr nul r s ce diplys t c r t itc des rbed by t : xta a a pa -- s a he ha acersi s ci he 720 Paent The e t . s c r cersisa eduet s um sac glcolt safi t t r a ha a t itc r o odi trh y ae' fniy owads queoustui . ( 6 Tra l ds 201 il Tr Da 1at75:2- 7,88: 1 LiteDiec;i at224: 225: Si Die ) . y 1 77: 6- 0, tl r t d 25- 25, nko rct. Sodi sa c gl a e ha a a fniy t r a ous tui a i r ognie i t um t r h ycolt s n f t owa d que l ds nd s ec z d n he pha ma e i l i ty as havi drmai s li pr tes ( 6 TralTr Day 2 a r c utca ndusr ng a tc welng operi . 201 i . t 1 2: 1 6,Pak Die ;i a 224:6- 233: 234: 245: 1 Par Cr s. Uponc a t 7 22- 73: r rct d. t 1 22, 20- 2, 8- 7, k os) ontc wih aq t ueous tui ,s um sa c gl olt t s i watr t s l,whi h f t sows t l ds odi t r h yc a e ake n e o we l c urher l he penerton oft tui i ot c tai he l ds nt he omposton. ( ii 2013Or ra 1 1. 201 TralTr Da 1a de t 8 425; 6 i . y t 76: 1 77: 8- 1 79: 1 81 3- 1 Lite D ie t i at 225: 25, 226: 5- 227: 5- 5, 1 78: 3, 7- 7, : 83: 4, t l r c ; d. 201 25, 23- 2 1 Si Diec) I fc,s u sac gl olt i known i t a ta aEhydr ,'t 28:9, nko r t. n a t odim trh yc ae s n he r s l ogel' he cls ofhydr lccompoundsmentone i t 1 Paent ( 6Tra Tr Day 2 a 1 : as ophii i d n he 720 t . 201 il . t 918- 1 224:6- Par Cr s. 6, 1 22, k os) 27 The hydr lc efe tofs um sa c gl a e c n be obs r ed i t W a s ANDA ophii f c odi t r h ycolt a e v n he ton t blt durng dis uton. Bas on Dr Buga s i a e i s ol i ed . y' mage , Dr Si t tfed t t t ç t s . nko esii ha he l vas mao i ' o s du sa c gy olt woud e s ousd o t e g a ls g v n is h g j rt ' f o im trh lc ae y l xit tie f h rnue , i e t ih molculrweg . (d a 76: 1 Si Re r t. I addii Dr Si tsiid t ts u e a iht 1 t 6- 3, nko diec) n ton, . nko e tfe ha odim 1 3 sac gy oaeo c pidbewe n 5 - 0 o t ee ta r n lrrg o (d a 81 1 21 . trh lc lt c u e t e 0 8 % f h xr g a ua e in. 1 . t :2- ) Dr Lite e ane t td i t fr tpha esofdis uton,t W a s AN DA t blt . tl xpl i d ha urng he is s s ol i he ton a e s l d t tepon t ttec aig wa b o e a d e e t lyr mo e ( 01 Tra Tr Da 1 wel o h it ha h o tn s r k n n v nual e v d. 2 6 il . y e a 81: 8 9,Lite Die t. Dr Lite obsr ahydr e lye a 32 a 42 mi e t ti t 3- 2: tl r c) . tl eved atd a r t nd nuts ha s i c tve oft s li t t woul be e ndia i he we lng ha d xpec e fom a hydr phii m arx ofs um sar h td r o lc ti odi tc gyc ae. (d. a 82: 83: . As t dis uton co i d, t t e' hydr t lye l olt 1 t 20- 5) he sol i ntnue he ablts aed a r c i d t s l e ode dii e a e,a r l as g anul f t r e de ofa hydr lc ontnue o wel, r , snt gr t nd e e e r es urhe vi nce ophii marx (#.a 8 6 1 8 2 - 4:) Dr Litetsiid a t e201 Tra,a d o r ma , h t ti . f t 3:-4, 3:3 8 7 . . tl etfe t h 3 il n n e nd t a t s be vi - s li u hi ha or we lng pon contct wih bufe ,e oson of t hydr t lyer r l as of a t fr r i he aed a , e e e g anulr sr t r , a f t r dii e a in of t hydr t d l r ai wih t : r a tuc u es nd urhe snt gr to a e aye - lgns t he 720 he Patnts des i i of t be vir of t outr hydr lc mati ( 3 Tra Tr Da 2 a e ' crpton he ha o he e ophii rx. 201 il . y t 1 76: 5, 1 8 9, tl 615- 1 63: 1 Lite Cr s 201 Tra Tr Day 1 at 75: 2- 1 78: 4- 0: Lite : 62: 7, 5- 2, tl os ; 6 il . Die t. rc) For t f e ng r as , I fnd t he e r gr nulr vol he or goi e ons i hatt xta a a ume e bis hy ophii xhi t dr lc c r trsi and doe note bi lpophii c r cersi s ha ace itcs s xhi t i lc ha a t itc .Thi outrvol s e ume i s pa ae fom s e rt r t ine vol m e Ac di y, t W aton ANDA Pr he n r u . cor ngl he s oduc c a ns a outr hydr phii t onti n e o lc m ati t e r g a a vol e w hi h e hi t hyd o lc c r t i tcs rx he xt a r nul r um c x bis r phii ha ac er s i . 1 Fort r as dic s d a 3 he e ons s us e bove i r e e t t i rlpophii m arx,t s um sa ch n ef r nce o he nne i lc ti he odi tr g y a e a t a t Sm ai c pone ' i t e r gr nul rr on. l col t c s s he ç n om nt' n he xt a a a egi 28 e The M ar h G r . kus oups i lc nd er Ha ng f vi ound t t W a s s ANDA Pr t co a ns a i ha ton' oduc nt i n nner Ipophii a out riulr r t on hydr lc marx,l fnd i ne e s r t a es a pa tc a a gument made by W a s on ophii ti i t c s a y o ddr s r ma e nd. W as c ends t tt Fe r lCic tf ton ont ha he de a r ui ound t cli 1 e udes e pi s fom hat am xcl xci ent r t i rvol oft grnul ( ,lpo lcmarx)t taeno lsedi t M akus gr p i he nne ume he a e or i phii ti ha r t it n he r h ou n cam 1a, n ta cam 1smia l e cu e e cpe t fo teo trv u ( r h d o hlc li () a d h t li i lry x ld s x i in s r m h ue olme o , y r p ii marx)t aenotlsed i i t M akus gr i cam 1b) Esental W as c ends ti hat r it n n he r h oup n li ( . s ily, ton ont t tt Fe r Cic tOpi on f e os a ûndi of i rnge nt whe t vol e oft ha he de al r ui ni or cl es ng nfi me n he um he i r lpophii ma rx c ans one lpophii s tnce a s r hydr lc s t nc s. nne i lc ti ont i i lc ubsa nd eve al ophii ubsa e ( 6 TralTr Da 2 at 1 20- 26:8, Par Diec;s e alo M ach 23,201 Cl i 201 i . y 25: 1 1 k r t e s r 6 osng Sttme ) ae nt. W a s pr e ed t sar um e t t Fe r Cic t ye t Fe r Cic tr m a t on es nt hi g nt o he de al r ui, t he de al r ui e nded t c s - not t tndi t pr e e ofnon-li 1a)e pi si t grnul and nonhe a e wihsa ng he esnc cam ( xci ent n he a e, cli lb)e pint i t e r a a s c am ( xci e s n he xtagrnulr pa e. TheFe r Cic tsM a edi n0tnec st et thydr lc e pint ca de al r ui' ndat d es iat ha ophii xci e s nnotbe i n t lpophii mati or t t lpo lc e pi s ca he i lc rx, ha i phii xci ent nnot be i t hydr lc m arx. The n he ophii ti Fed a Cic tsr quie er l r ui' e r menti t tt M a kus g oup lmia i c s ha he r h r i ttons ompe a cli consr c i l am tu ton t tr r s t tt i r lpo lc m arx i s pa a e fom,butdoes notnec s a iy r r ha equie ha he nne i phii ti s e r t r e s rl equie ditncte pi s fom ,t out rhydr phii ma rx.Waton I 787 F. a 1 si xci ent r he e o lc ti s L 3d t 366. l e t nde d, he Fe r Cic tc e a e t tt r c d be st tonswhe e t m arc c an e pi s de al r ui ont mplt d ha he e oul iua i r he ties ont i xci ent ou sd oft rr s tve M a kus gr . Se W a s I 787 F. 1 ti e hei e pec i r h oups e toa L 3d 359,1 (l hehe or 368 tW t r no a c pos to i rng w he t r i a tac ofhy o lc m ol ul s i t i r vol e t om ii n nf i es n he e s r e dr phii ec e n he nne um 29 be aus oft m i ng se i e i t ma acurng pr es ,-/ e c e he xi t p nher nt n he nuf t i oc s br xampl ,i a que ton f e s si or t efc fn e a)(mp ssa d d . h a t i d r' e ha i d e ) ' I t r soft composton oft g a e net rShie norW a s pr s nt d e de n em he ii he r nul , ihe r t on e e e vi nce as t t e c a ount of mag i se r t wihi t g a e.Evi nc was pr en e , o he xa t m nesum t a ae t n he r nul de e es t d howe r t ts wed t twihi t ime vol e oft gr nul,mag i se r t c d not ve , ha ho ha t n he r r um he a e nesum t a a e oul e e a t r i l maxi xc ed heoetca mum of 5%. ( 2016 Tral Tr Da 2 a 11: 23,Si Cr s. i . . y t 6nko os) Addii tonale de e s vi nc howe t tt r mai ng e i e s i t vol d ha he e ni xcpint n he ume of t g a e wer he r nul e hydr lc s tnc . (d a ophii ubsa es 1 t Si Cr s. Howe r a dic s d a nko os) ve , s suse bove, t he ma sum se r t i t m an c gne i t a ae s he i omponen of t i r vol e of t gr es The ot r t he nne um he anul . he hydr phii e i e s i l ngt s um sa ch gl a e1- ar unr 1t t t f i of o lc xcpi nt- ncudi he odi tr ycolt 4 e ea ed o he uncton t i rlpo lc marx. ( e 201 TralTr Da 1 a 70:- . The pumos oft i r he nne i phii ti Se 6 i . y t 14) e he nne lpo lcmarx i t conti et t c r ld r e eoft mes lmi ( 3 Or ra p. i phii ti s o rbut o he ontole elas he aa ne. 201 de t 1 n. . Dr.Si and Liter fi d a t 201 Tra t tt hydr lccompoundsi 8, 25) s nko tl eafnne t he 6 il ha he ophii n t g a e do nota f tt ove allpo lc c r c e oft tvol e t y do notha a he r nul s fec he r l i phii ha a t r ha um - he ve n efc ont r e eofmes a nefom t grnul ( 6TralTr Da 1at70:- .5 fe t he elas almi r he a e. 201 i . y 14)1 W as c e t tt pur e oft i uson ofm a i se r t i t ANDA ton ont nds ha he pos he ncl i gnesum t a ae n he Pr twasa a l i nt Ipr vi l f oduc s ubrca . e ousy ound t tm a i sea a edoe ac a a l i a ha gnesum t r t s t s ubrc nt howe r If ve , ound t tm ag i se r t o y e bie t c r c e itc ofal iantwhe i ha nesum t a a e nl xhi t d he ha a t rsi ubrc n t 1 Ipr vi l f 4 e ousy ound t t s um sar h g y ae wihi t gr nul s w a ir e nt t t ha odi t c l col t t n he a e s relva o he r e eofme aa nei my201 Or r ( 3Or ra 1 n. . elas s lmi n 3 de. 201 de t 8, 25) 1 N Ot bl , i a ton t t im er lpo lc a out hydr lc m a r c pr ded i c ai 5 a y n ddii o he r i phii nd er ophii t i es ovi n lm 1a a cai 1b) cam 1c pr de f l i lyot re pi s' Neiheroft Pa te () nd l m ( , li () ovi s or d onal he xci ent.' t opt he ris ha bree orague a how ls dconsr cam 1c . Howe r t tcl m 1a a st s ifd r d bout houl tue li () ve, ha ai ppe r o al i he e i e s't ndst s low t r xcpi nt,' e ot o uppor t ot rexcpi nt wihi t i rvol e a out r t hat he i e s t n he nne um nd e vol e whi h ar unr l t t t f ton of t e vol e as imer lpo lc a outr um , c e e aed o he unc i hos um s l i phii nd e hydr lcm arce ,woul bepe ted. ophii ti s d nnit w as i t e r gr nul r s c ( 3 Or r a p.1 n. . lf n he xt a a a pa e. 201 de t 8, 25) ound t twhe ma i ha n gnesum se r t wa l a e wihi t gr nul i a f c st r l s ofmes l i I t a a e s oc t d t n he a e t fe t he eea e am ne. d. Addii l W a s a gue t tt pr e e ofm a i sea at i t e r gr nul tonaly, ton r s ha he es nc gnesum t r e n he xta a ar s a eme nsta teo trh d o hlcmarx (h e ta rn a v lme v oae t ecam 1b p c a h t h u e y r p ii ti t e x rg a ulr ou ) i lts h li ( ) M ar h gr kus oup.Howe r t mag sum sea a e i t e r gr nulrs e i ove whel e by ve , he ne i t r t n he xta a a pac s r m d t h ophii pr risoft s di sac gl aei t e r grnulrs ce ( 6 Tral he ydr lc opete he o um trh ycolt n he xta a a pa . 201 i Tr Da 1a 224: 21 Si Diec (esiyi t ts um sachgl ol ei mor Spotntt n . y t 3- , nko r t t tf ng ha odi tr yc at s e t e ha t mag seaae o sde') The s di sach gyc ae i t man c he t rt uti ' . l o um tr l olt s he i omponent of t he e r r nulr vol e and lpr vi l f xtag a a um , e ousy ound t ts um sa c gl a e i t e r gr nul r ha odi t r h ycolt n he xta a a s ewilafctt rl eoft mealmi 201 Or ra p.1 n. . pac l fe he eeas he s a ne.( 3 de t 8, 25) l s t t i rlpophii ma rx i c prs d oft vol ew ihi t gr nul . The n hol he nne i lc ti s om ie he um t n he a es vol wihi t ganuls c ans mag sum se rt,whi fls wihi t cli 1a ume t n he r e onti ne i taae ch al t n he am () M ar us gr k h oup. The i r vol nne ume e bis lpophii c r c e itc . Ot r e pi nt, not xhi t i lc ha a t rsis he xci e s wihi t cli 1a M akus gr aeprs ntwihi t i rvol t n he am () r h oup r e e t n he nne ume. Howe r t s ohe ve , he e t r e i e sdo nota f ctt lpophii c a t rsi oft im e vol m e and,t ,a e unr lt d xcpint fe he i lc har c e itc he l r u hus r ea e t t lpophii m a rx. o he i lc t i e ophii rx s om ie he um s de he Si l ry, t out r hydr lc mati i c prs d of t vol e outi of t mia l he g a es o ,t e r a a s e. Theextag a ars ce c anss um sa c gl a e r nul , r he xtagr nul r pac r r nul pa ont i odi t r h ycolt , whih flswihi t cl m 1b)M akus goup. Thee r grnulrs eexhi t hydr lc c al t n he ai ( r h r xta a a pac bis ophii chaa trsi . Mag i se ae,a e i e notwihi t cli 1b)M akus gr i rceitcs nesum tart n xcpint t n he am ( r h oup, s pr esent wihi t extagr ar s t n he r anul pace. H owever,t m agnes um s ear e does not af ect t he i t at f he h ophii c r t itc of t e r gr nul r s ce a t ,i unr a ed t t hydr lc ydr lc ha ac ers i he xt a a a pa nd, hus s el t o he ophii m a r x. ti C onc us on l i Bas d upon m y fndi s t f t a e i ngs e orh bove a m y undit bed fndi fom t 201 , nd sur i ngs r he 3 Or r Pl ntf s ha e t bls d,by a pr ponder nc ofevi nc t tt W a s AN DA de , ai if ve sa ihe e a e de e, ha he ton Pr tm e t t a to lr r m e s esa ihe by t Fe r l Cic t f t cli oduc e s he ddii na equie nt t bls d he de a r ui or he am co tu to of tnne lpophii ma rx' a ç e hydr phii m a rx. Thus Def nda s nsr c i ns i r i i lc ti ' nd ' r out o lc ti ' ' , e nt havei rnge c am s1 a 3 oft 1 Pa e . nfi d l i nd he 720 t nt Addiinal a Ifundi t 201 Or r W as Phamac uteas l ( knowna to ly, s o n he 3 de , ton r e i l, nc.now s Aca s 1 )knowi y i e W as La aores I Fl i W as n Pha ma,l , tvi, nc. ngl nduc d ton bort i , nc. orda, to r nc. and orW a s La a ores l .t i rngeand/ c rbut t W a s La aore ,l / ton bor t i , nc o nfi or onti ed o ton bor t is nc. Fl i s W a s Pha ,I ' ,a W a s La a ores l ' i rng ntof$ 20 Pae , orda' , t on nna nc.s nd ton bor t i , nc.s nfi eme 7 tnt cams1and3.( 3Or ra 30,n. .Eac oft Dee nt i uc orc rbutdt t li 201 de t 42) h he fnda s nd ed onti e o he consr cton oft W a s ANDA Pr ta t flng ofANDA N o.203817.1 tu i he ton oduc nd he ii d. P an if ae t ee o e e tte t ter q e td ij n tv r le . Fna j d me ts al litfs r , h r fr , n ild o h e u se n u cie eif i l u g n h l is by s r t or r. s ue epa a e de DONE AND ORDERED i Ch mbesa WetPam Be ,ti Z n a r t s l a hs d yofMac a rh, 201 6. / D M. I M DDLEBROOK S UNI TED STATES DI STRI J CT UDGE Copist e o: Co elofRec d uns or 32
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