Valeant International (Barbados) SRL v. Watson Pharmaceuticals Inc. et al, No. 1:2010cv20526 - Document 155 (S.D. Fla. 2011)

Court Description: MEMORANDUM OPINION finding that Watson has failed to prove by clear and convincing evidence that Valeant's asserted patent claims are invalid. The Court will enter judgment in favor of Valeant and against Watson. Signed by Chief Judge Federico A. Moreno on 11/7/2011. (mmz)

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UNI TED STATES DI STRI COURT CT FO R TH E SO U TH ER N DI STRI T O F FLO R I C DA C ase N o.1020526-CIV-M O R EN O VA LEAN T m TERN A TI A L ON ( BARBADOSISRL, Pl n if ai t f , VS. W ATSON PH ARM A CEU TI LS, C. CA m , W ATSON LA BO RATORI m C . ES, FLO RI ,a W A TSON PHA RM A ,m C. DA nd Def nt . enda s M EM O R AN D UM O PIN I N O Thi a ton was f l d by V a ea l e natonal ( r dos SRL (t la ' a ns s ci ie l nt nt r i Baba ) û e nt' gai t va ) s bor t i s ncv or da nd t on r nc W a s Phar a eu i l , l , W at on La a or e , l - Fl i , a W a s Pha m a, I . t on m c tca s nc. (oleci l ûWaton',alegi pat i rnge nt Vae i t owne ofs vealpae s c l tvey, i s ' l ng ent nfi me . lant s he ) r e r tnt r l td t t dr known a Aplnzi . W a s s e t ma ke t ge rceq valntoft t e ae o he ug s e nl ton e ks o r t he ne i ui e ha dr ug. W a s has c e ton onc ded i rnge nf i mentbuta s rs a an afi ma i def ns t t Vala ' s et s tr tve e e ha e nts as e t d pa e sa e i ld. s re t nt r nva i pr on dr omi s he c i Aplnzi i a a i pr s a t t c ans bu opi hy obr de a t a tve e n' s n ntde e s nt ha ont i i r dint Vaea owns f paent r a e t Aplnzi : U. Pa e Nos 7, 61 ng e e . l nt our t s elt d o e nl S. t nt . 569, 0, 7,63,23,7, 01 a 7, 992 (ole tvel ûhepae si s f'.Ea h oft paent-n5 8 649, 9, nd 553, c lci y,i t tnt-n-ui ) c he t si s tc ai s ve a cl i s l or r t s r m lne t i s f ti l t pa tes a ee t ty ui ont ns e r l a m . n de o tea i he s ues or r a , he r i gr d o r t sca eonl wih r s c t fver e e atv cl m s i t paent,wih t r s uton oft hi s y t e pe t o i cpr s nt i e ai n he t s t he e ol i he i s es conc r ng t e cl m s be ng di pos tve a t a1 of t pr vi l as e t cl i s a su e ni hos ai i s ii s o 1 he e ous y s red a m s bewee t pates Therpr enttvecai oft paent-n-ui ae:( )Cli 3oft $ 0 t n he ri . e es ai l ms he t si s t r 1 am he 61 pae ;( Cl m 9 oft : pae ;( Cli 1 oft $23pae ;( Cli 2 oft 1 9 tnt 2) ai he 823 tnt 3) am 0 he 8 tnt 4) am he 01 paent a ( Cli 1oft $ pa e . The r pr e a i cai sr l t t c r l r l s t , nd 5) am ' he 992 t nt e es nt tve l m e a e o ontoled eea e a onc a da f m ultons of bupr on hy obr de,mehods of te tng de es i wih nd e- - y or a i opi dr omi t rai pr son t t e f r a i ,a as cii cr t li f m ofbupr on hy o omi hos o multons nd pe fc ysalne or opi dr br de. Th Co r h s u idcin o rt ep risa dt es be t te p ru n t 2 U. C. e u t a j rs it ve h a t n h u j c matr u s a t o 8 S. j o e 1 a . Addii l ve i a oprae unde 28 U. C.jj 1 and 1 b) Net r 338() tonaly, nue s ppr it r S. 391 400( . ihe j iditonnorve i contse byt pate . TheCour c urs ci nue s etd he ris t onduce abe h ti fom J td nc ral r une 21 2011t J 28,2011 Thi M emor ndum Opi on c tt e t Cour' fndi off c , o une . s a ni onsiut s he t i ngs a t s a con usonsofl w on t i s r i e durngti l Uli t l t Cour fndst tW a s nd cl i a he s ues a s d i ra . tma ey, he t i ha ton ha f ld t pr by clarand c ncng e denc t tVala ' a s td pa e cai s a e s aie o ove e onvi i vi e ha e nts s ere t nt l m r iv l a da c r i l g a t j d me ti fv ro Vae n . n ai n c o dngy, rn s u g n n a o f la t d, 1.Background Bupr on w a i nt by N a i a M eht i 1 opi s nve ed rm n a n 969 as a m e hod of tea i de es i t r tng pr son a wa s bsque l pae ed by Me a i 1 i U. Pae No.3, 1 706 (he t e a nd s u e nty tnt ht n 974 n S. tnt 8 9. t k ht M pae ') ( .Ex.1 ) W hiet M e apae me i anumberofbu o on s t,i does tnt'. Def 35. l he ht tnt ntons prpi als t not s cii ly me i bupr on hydr omi ( .Ex.96 ! 54;Tra Tr 437: pe fcal nton opi obr de. Pl 553il . 25 438: 1) Bu o onhasbee s d snc t 1 a t bupr onhydr ordes l,unde t 1 . pr pi n ol i e he 980s s he opi ochl i at r he brndna W elbuti ( . 98!18;De.Ex. a 1 ) Toda bot brnde a ge rc a me l rnl. PlEx. f 602 t 0. y, h a d nd nei ve s ons of b opi h ochl i ar on t e m a k , i l ng ge i v s ons s d b ri upr on ydr orde e h r et nc udi nerc er i ol y W as n.( .Ex.9 a 8 ) to Pl 4 t 6. Si e t ea l l 0s howe r i wa known t tbupr on hydr hl i ha sa lt nc he ry 98 , ve , t s ha opi oc orde d tbiiy pr e whe c obl ms n ombi d wih pha m a eu i le pint . ( f Ex.1 a 20556- .Def Ex. ne t r c tca xci e s De . 28 t 57, . 2 60 at1 -1 ) Bewe 1 and 2004 ma atmpt weema t i ovet sa lt of 2 8 9. t en 984 ny te s r de o mpr he tbiiy bupr on h oc ordef opi ydr hl i onnultons ( i Tr 66:8- 25;3011 303:6;Pl Ex.94 a 38. ai . Tral . 1 68: :0- 1 . t ) One of t frt s h a tm pt was a l 4 patnta iaton b Bilnghur t whe e he t t he is uc te s 98 e pplc i y li s r esed s ve a dif r ntbupr on s lst s i a ha i ove sa lt r a i t t hydr ord e r l fe e opi at o ee f ny d mpr d t biiy eltve o he ochl i e s l.( f Ex.l .Pl Ex.94a 38;De . 379a 40832. at De . 28, . t f Ex. t )Amongt s lsBilnghurtt t he at li s esed wer a numb ofmi rlacdsl alofwhi wee t nd t be unsabl ( i Tr 473: e er nea i , l ch r bu o t e. Tral . 22474: 1. Aswast c s i t M e apa e ,t hydr om i s l wa neihe m e i ned nor 1) he a e n he ht t nt he obr de at s t r nto t td. ( ilTr 66:8- l ) Onl t malaes t whih i a or ni c r oxylca d s t ese Tra . 1 67:5. y he e t al, c s n ga c a b i ci al, wa f s oundt ha i ovedsa lt ( f Ex.602 a 1 1 .Tra Tr 43 21436:0. Duet o ve mpr tbiiy. De . t 8- 9, il . 4: - 1 ) o t c og c r ,howe r i c d ne be f multd i o a c oxiol y oncens ve , t oul ver or ae nt ommer alpr ct ( . ci odu . Def Ex.1 at20557;Tra .435:0- .Ma De 1 20- 31: ) Durng t t nt ye r 28 ilTr 1 23, es p. 30: 1 24. i he we y as f l ng Bilng r ts f ld at m p t fnd an aler tve s l wih i pr d s a lt ove olowi li hu s' aie te t o i t na i at t m ove t biiy r bupr on hydr hl i ,no n efors we e ma t fnd a dif r ntbupr on s l;i t d, opi oc orde ew f t r de o i fe e opi at nsea ot rme nswe e e or t i ove sa lt ofbupr on hydr hl i f mul tons s ve a he a r xpl ed o mpr t biiy opi oc orde or ai , e r l ofwhihwer s e c e ubsquentypae ed.( i Tr 66:8- 25.Def Ex.602at1 1 ) l tnt Tral . 1 68: . . 8- 9. Des t t v i atempt t i ove t sa lt of bu opi hydr hl i pie he arous t s o mpr he t biiy pr on oc orde f mul tons t s l lf ofcommer i bu opi hydr hl i t bl t has r mai s t or ai . he he f ie cal pr on oc orde a es e ned hor, w ih onc - da f m ul tons ha ng ne ac eve a s f lf l er t n e g e n m ont . t e a- y or a i vi ver hi d hel ie ong ha i ht e hs ( il Tr 299: 300: ) Thus i 2003, Val nt (he Bi i) s t out t a es t Tra . 23- 4. ,n ea t n oval e o ddr s he l t ng sabiiy is eswih bupr on hydr hl i f multons ( il Tr 298: ongsandi t lt s u t opi oc orde or ai . Tra . 20299: ;303:7- ;380:6- 1) W hie Vala tid a numbe of difrnt a oa s i 20 1 22 1 2. l e nt re r fee ppr che , t uli a e y de de t r vi i w ha Bilnghur t ha ate pt d bu f ied t dicove i 1 tm t l ci d o e s t t li s d tm e t al o s r n 984 a 1Hydr orde,hy obr de s ft ,a ph ph e ar aI e ochl i dr omi , ulaes nd os ats e l xampl ofmi r a d s t. es ne al ci als ne bupr on s tt c d be f m ult i o a c mer alpr twih an e e d s l w opi al hat oul or aed nt om ci oduc t xt nde hef lf. ( ilTr 3 3:4 2 ) Th g a o t i n w s l p oe twa t e tn t e s eflf o i Tra . 0 1 - 2. e o l f hs e at rjc s o x e d h h l ie f e W el ti wihoutne tveyi ci a ofisot rpr ri .( ilTr 307:- ) lburn* t gai l mpa tng ny t he ope tes Tra . 5 8. Thefrtse i tep oe twa t fg r o twh ts lso b p o i nc ul e e b ma e is tp n h rjc s o iu e u a at f u r p o o d v n e d . ( a sDe Tr 6 1 1 ) Be a eVala wasnots ci i d i ma a t i ne s ls i M e p. . 4:5- 6. c us e nt pe alze n nufcurng w at, t s oughtt a ssa eofa lainche c lc he s itnc n tla mia ompan known asChe S. A.(1 mi'.( s y mi P. çChe ') Mae Dep.Tr 64:5- 6. Vae ta Che s nts vealmont atmptng t ma ne s t, . 1 65: ) lan nd mi pe e r hs te i o ke w als ma ofwhihf ie t rs ti atsa epr t ( .lx. ,Def Ex.98. Thei s e ton ny c ald o e ul n etbl oduc. Def 1 95. . ' ) r elci ofs ls wa l g y a e rc pr e s be aus i wa ditc tt pr di te ty whi s l at s ar el n mpiial oc s , c e t s fi ul o e c xacl ch at woul bet bes .( ae De 8 2- ,1 23- 71 l ) d he t M s p. 4: 6. 70: 1 : 3. l 200 t i t s fo Valanta Chemim a bupr on h obr de. They n 4 he nven or r m e nd de opi ydr omi dic r d t tbupr on hyd obr de e ss i man f m s bo h a o housand c ysali s ove e ha opi r omi xit n y or , t m p r t lne. ( f Ex.604 a 1 Pl Ex.96 a 1 .Tra Tr 643:6- 671: 15. Among t s f mswas De . t 0; . t 5, il . 1 25: 2- ) he e or t ver sa e c ysa lne c pound Fol lbupr on hydr omi cover d b Cli l of he y t bl r t li om ' m opi obr de e y am t $ paent ( ilTr 22 1 225: ) The ive or alo t td bupr on hy obr de he 992 t . Tra . 4:6- 8, n nt s s ese opi dr omi an dic r t t bu opi hydr om ie i a c rll r l s f multon pr ce a d s ove ed ha pr on obr d n onttled-eea e or a i odu s m u h mor sa e pr c e tbl oduc r ltve t c r s t ea i o ore pondi bupr on hydr hl i f multons ng opi oc orde or a i . s s e ha opi ( ilTr 311:8- 2: P1 Ex.95 a 01 3l 1 Tra . 1 31 8; . t 5 9, 54331. They alo dicover d t tbupr on ) h obr de onc - - y t e sc n be f ydr omi e a da ablt a onnult d a a1 t r comm e d daiy dos s e a e t l he e nde l age , ven t hi s dos ge,whih ha ne r be n a co pls d wih bupr on hydr hl i ( i he ghe t a c d ve e c m ihe t opi oc orde. Tral Tr 31 25- 6:3.PlEx. !34. . 2: 31 1 , . 98 ) Asar ul oft sr eac prj t Vae ntwa a et de l Aplnzi aonc ada es t hi es rh oec, la s bl o veop e nl, e-- y bupr pi hydr br de t e c e b t paent-n- ui. The e f c i flng dae oft o on o omi ablt over d y he t s i s t fe tve ii t he pa e s i s ti J 27,2005. Valan lunc d Apl i i Aprl2009. Les t ayea t nt-n- ui s une e t a he enzn* n i s han r ltrW a s s ae ton ough FDA a ovalt mar e a ge rcveri ofApl nl ,whi h W a s has t ppr o k t ne i son enzi c ton c e d i rnge t pa e t -n- ui. The ef r ,t s e is f ti lwaswhe he e c oft onc de nfi s he t n s i s t r o e he ol s ue or ra t r a h he a s td c am si t f pa e t -n- ui i i ld, s ere l i n he our t n s i s t s nva i I D i si I. scus on a ut he ent i s t i pae s l be prs d vai ' 35 U. C.j 282. By stt e,t pat s-n-ui k tnt hal A e ume ld. ' S. ù ve a sr pr s t ha tong e umpton ofvaldiy i i rng i i t n nfi ementpr e ngs' Alsie Cor v VSll ' oc edi . - t ' p. . ntl , l ,17 F. 1 nc. 4 3d 308,1 ( d.Ci.1 .Thi pr umptonofvaldiyapple i pe nty 323 Fe r 999) s es i it is nde nde l t e chcai wihi apatnt e n i ot rcl mswihi t paentaehel i ld.35U. C.j o a lm t n e , ve f he ai t n he t r d nvai S. 282. A c or ngl W a s m us pr i i t f ea as ere cl i . c di y, t on t ove nvaldiy or ch s t d a m To ove c e t pr umpton of vai t t c le r has t bur n of pr vi by r om he es i ldiy. he ha lnge he de o ng ce ra d c n icn e ie c ta t ep tn i iv ld M ir sj Cop.v iiLt Pa t es p, la n o vn ig vd n e h t h ae t s n ai. c o qt r . 4 d rn rhl . 1 S.Ct 2238,2242( 1 .Cl randconvi ngevi ncei e de t tplc i t f t 31 . 201 ) ea nci de s vi nce ha a es n he ac fnde ia a di conviton t tt tuh ofrhe t t lcontntons gs hi y pr bl ' i r kn bi ng ci ha he r t t j àcua e i iq ghl oba e.' Col ado v Ne M e co,467U. 31 31 ( 984)(ntr lquottonsomitd) ûgl t fc or . w xi S. 0, 6 1 i ena ai te . çlf he a t tir of t is i lf unce t n,t pa t wih t bur n l e ' Te Li e n Cor v re he s ue s e t rai he ry t he de os s. ch. c nsig ' p. . Vi otk,l . 5 F. 1 6, 1 ( de e nc, 45 3d 31 327 Fed.Ci.2008) 'hi bur k s c t a r m ans r . l s den l onsant nd e i ' i t oughou t s ton t c lng ' a ' hr t he ui he hale er' nd k doesnots f a a tm et t pa e owne . hit t ny i o he t nt r' ' La .,l c v Prf'Po iin r , n . 7 4 F.d 9 5 971( d. r 1 8 ) Mo e v r wh nt e b% n . . l 1 sto e s l c, 2 2 6 , Fe Ci. 9 4 . r o e, e h . Pa e O fi e ha c i r t pror a t durng pr e ton of t pa e s t bu den on t t nt fc s ons de ed he i r i os cu i he t nt , he r he c le rt esa ih i i t i eve hea e . Gl Lt v.Apotx,l ,376 F. 1 hal nge o t bls nvaldiy s n vi r axo d. e nc. 3d 339, 1 ( d.Ci. 348 Fe r 2004) I xLabs,l .v. entsPhar .I ,468F. 13 1378( d. r , *mpa . nc Av i ms, nc. 3d 66, Fe Ci. 2006 . ) He e,W a s c l est valdiy oft fve r e e ai pa e cl m son t ba i r ton haleng he i t he i epr s nt tve t nt ai he ss t tt y ae ( )a ii td by t prorat a / ( obvi i vi oft prora t The ha he r 1 ntcpae he i r; ndor 2) ous n ew he i r. Cour wilad es e ch a gume i t n. t l dr s a r nt n ur A.Antc pai ii ton W a s con e t t Cl m 3 of t $ 0 pa e a Cli l of t 1 paen a e t on t nds ha ai he 61 t nt nd a m he 992 t t r ivai fra tci tonunde 35U. C.j l b)?Genealys a ng,û ii ton me nst t n ld o ni pai r S. 02( . r l pe ki û cpai Ant a ha t ca me i ton wa pr vi l known,a t tal oft elm e sa lm ia i oft he li d nven i s e ousy nd ha l he e nt nd i ttons he ca ms a e de crbe i a sngl prora tr f r e. l akm v Cannon Av ntGr p,#1C,479 li r s i d n i e i r e e enc ' - i . ' l e ou F.d 1 3,l 9 ( d.Ci.2007) s as SJnt 470 F. a l (tAntcpai r rsa 3 31 31 Fe r , . ee lo ? #, 3d t 375 kg ii ton) equie fndi t tCa a e r lmia i i f i ng ha e ch nd ve y i t ton s ound eihe e es l ori r nty i asngl prora t t r xpr sy nhe e l n i e i r rfrnc f' ( i Cee ias Te hs f/f v Roc wel l ' Cor , l 0 F. 1 eee e.') quotng lrt c . ( . k l ntl p. 5 3d 354, 1 361 ( d. r1 . Antci ton i aquesi offc. EI Lil t Co.v Ze t Gol i Phar . Fe Ci.998) i pai s ton a t i ly f . nih dlne ms, l , F. 1 1 ( d.Ci. nc.471 3d 369, 375 Fe r 2006) . Fora prorar r er e t a ii t a cli e i nton,t r e enc û tnotonl i t ef enc o ntcpae am d nve i he ef r e i mus y dic os al elm e soft c am wihi t f cor r oft doc e ,butm us alo dicl e s l e l e nt he l i t n he our ne s he um nt t s s os t e e em e s a r d as i t c a m . NetM tne N ,l . v Ve i i I . 5 F. l hos l nt range n he l i ' ' l yl nc . r sgn, nc , 45 3d 359, 1 ( 369 Fed. Ci. 2008) (ntr l quot i omit . -glhe r e e e mus cla l a r i ena atons ted) b-j efr nc t e ry nd une vocal dicl et cli d gnve i ordiec t es ledi t a tt t (nve i qui ly s os he ame i ntonj r t hos kil n he r o he i ntonj wihoutan nee f pi ng,c t y d or cki hoosng,a c i nd ombi ng va i dic os e notdiec l r l e t ni rous s l ur s r ty eatd o 2Cl m 3oft : 1 p e i die t t an i ovedmehod ofte tng de e son usng aoncea- ybupr on ai he 6 0 atnt s r ced o mpr t r a i pr s i i - da opi hydr omi dos e f m.Cli 1oft $ paen i diece t as cii a hi y sabl cr tli obr de ag or am he 992 t t s r td o pe tc nd ghl t e ysalne compoundofbupr on h obr de Fo m Ibupr on h obr de. opi ydr omi r opi ydr omi 6 e c ot rby t t ac ngsoft ct d r e e e.' I r Ar e 59 C. P. 804,455F. 586, a h he he e hi he ie ef r nc ' n e kly, C. A. 2d 587( C. A.1 . Anydifrnc bewe nt proratrfr ea t cai i ton, C. P. 972) fee e t e he i r eeenc nd he l med nveni no m at how si t de e t a a i pa i c le t valdiy. Net one N,5 F.d a ter lgh , f a s n ntci ton ha lnge o i t M yl 45 3 t 1 .Ase ane by t Fe r lCic ti NetM one NL 371 xpli d he de a r ui n yl Thus i i note ,ts nough t tt prora' r e enc di cos pa tof ha he i l efr e s l es r t t cli e i nton,whih a or na y a ts n m i s plm e he am d nve i c n di r ria ght up e nt t m a t whol,ort ti i l o ke he e ha t ncudes muli e ditnc t a hi tpl . si t e c ngs t t a ts n mi s e hat he ria ght om how c bi t a hi t cl med om ne o c eve he ai i nventon. i 1 I ot r wor ,e e nt ofa cl m t tar notpr s nti t sngl pi c ofprorar on d. n he ds l me s ai ha e e e n he i e e e i t whih t a ii ton de ens i bas d may notbe s id by t k c he ntc pai f e s e upple he nowldge ofone s le i e kil d n t al ort dicos e ofano he r f r nce. SeeSt u u alRubbe Pr .Co.v.Par Rubbe he ' he s l ur t t r eee r ct r r ods k r Co.7 F. 7 ,71 ( d.Ci.1 4) se aloEl LW.and Co.v SiorPh ms,l . 705F. , 49 2d 07 6 Fe r 98 ; e s i p . c ar . nc, Supp.2d 971 992 ( D.l 201 (:n s ng t t al elme s of a i nton wee , S. nd. 0) ' howi ha 1 e nt l n nve i r a i pa e t cha lngi pa t ma notr y upon t knowldge ofone s led i t e a tor ntci t d, he le ng ry y el he e kil n h r t dicl u e ofa he r e e et s y mi sng elm e s.) he s os r not r ef r nc o uppl s i e nt ' . ' He e,W as a s rst tCl m 3 oft $ 1 patnta Cli 1 oft ; patntar r ton s e t ha ai he 6 0 e nd a m he 992 e e a iiatd byt 1 Meht pae .( .Ex.1 ) TheCoul fndst tW as ha notme ntcp e he 974 a tnt Def 35. ' i ha ton s t t t e ctng s a r f a i pa i w ih r pec t e t rcl m . he xa i t nda d or ntci ton t es t o ihe ai 1 Cl m 3o he ' pat i notantciat . ai ft 610 ents i p ed Cli 3 of t 5 0 pa e i a depe nt cl m whih i or a e by r f r nce t am he 61 t nt s nda ai c nc por t s eee he eeme s ofCl m l oft $ 1 pa e . W he t t cai s a e i e atd Cli 3 r ads a l nt ai he 6 0 t nt n he wo l m r ntgr e a m e s f l s: olow A m e hod of te tng de es i c prs ng a i s e i a t rai pr s on, om i i dm ni t r ng n ef e tve a oun of bu opi h obr i i a onc - l fci m t pr on ydr om de n e daiy dos t tea de e sont as j ti ne dt rof age o r t pr si o ubec n e hee . ai e r ha he opi obr de s ( f Ex.003 a 786051. Thus,Cl m 3 r quiest tt bupr on hydr om i com prie a De. t ) t ts s t ha he ht t nt ont i s os e ny onc dal dos ge f m . Ye i i undipu ed t tt M e apa e c a nsno dicl ur ofa e- iy a or onc - l d a f m . ( f Ex.1 ) l e W as ha a te ass h i ispos-ral edaiy osge or De . 35. nde d, ton s dmitd uc n t tti flngs ( .No.1 a 6. Thi al pr ude a tndi t tCl m 3 oft $ 0 paen i ii . Dkt 41 t ) s one ecl s i ng ha ai he 6l t t s a i i t d by t M e a paen ,a t cli d i ton m us be i ntc l dicos d i t ntcpa e he ht t t s he a me nven i t de ialy s l e n he ct d prora t ef e e.NeM one N,545 F.d a 1 1. ie i r r er nc t yl 3 t 37 W a s n a gue t t Cl m 3 i ne rhees a ii td be us onc - l dosng of t o r s ha ai s ve t l s ntc pae ca e e daiy i bupr pi was wellnown i t pror a tby 2004 and t woul im me ael ha be o on l t n he i r hus d t i di t y ve en e sge byapes ofor nar s l i t ar i 2004 r di t M e a$ pae . ( t nvia d ron di y kil n he t n ea ng he ht 706 tnt' Dk. ' No. 41a 5) Th sag me tho ve,se a t t k n o ag me tt th sb e rj ce b 1 t . i ru n , we r i x cl he id f r u n ha a e n ee td y y t Fede a Cicui. Se ,eg. Stuct alRubbe Pr s.(4 v Par Ru he r l r t e . , r ur r od - . k bberCo. 749 F. 707, 0. , 2d 71 ( Ci.1 ;NeM one N,5 F.da 1 .Thus t Me apae doesnota i pae 6 Fed. r 984) t yl 45 3 t 371 ,he ht tnt ntci t cli 3 oft 1 0 pa e . am he 61 t nt 2 Cli 1o h '9 pa e tsn tih r n l a tc e . am ft e 9 2 tn i o n e e t n ipatd y B . bvi nes O ous s W a s a s con e t tCl i s9 a 1 oft e - pa e ,Cl m 2 oft $ 9 pae , ton lo t nds ha am nd 0 h 823 t nt ai he 01 tnt a Cl i 3 oft û 0 pae a e i ld f obvi nes . A pa e tm a no be ob a ne t ft nd am he 6l tnt r nva i or ous sc s tn y t t i d û he i difrn e b t e te s b e tmatrs u h t b p tn e a d t p ira tae s c ta te fe e c s ewe n h u j c te o g t o e ae td n he ro r r u h h t h s b e tmaterasa whol woul ha be n obvi a t tmet i i wa madet a ujc t e d ve e ous t he i he nventon s o pes havi or nar s l i t att whi s i s j tmatr pe ti .' 35 U. C.j ron ng di y kil n he r o ch ad ubec te rans' S. Thease td cl msoft 4 a * l paent r aet combi ng bupr on hy obr dewih ph ma tc s re ai he 823 nd 0 9 t s elt o ni opi dr omi t ar ceuial e pint t pr du c tole r las and onc ada bu opi hy obr def muai . Cl m 3oft 1 ! xci e s o o ce onr ld ee e e-- y pr on dr omi or ltons ai he 6 0 pae r lt t us oft e fnnul i t te dep es on. tnt eaes o e hes o atons o rat r si 8 S vi nes i a que ton of l bas on unde li f c s' Gr p One Lt v. k ous s s ob , d. si aw ed ry ng a t . ' ou 1 (. 03a) balmar Car / . 407 F. 1 l l k ds nc, 3d 297,1 ( Ci.2005) Ob ous si dee mi d wih 303 Fed. r . vi nes s tr ne t r s e tt te s be tmatra awh l, o sp rt pe e o t ecam.Sa n s th lb v e p c o h u j c te s oe n t e a ae ic s f h li n h-yne ea o . Apotx,/7.550F. 1 1 6( d. r 2008) e /c, 3d 075, 08 Fe Ci. . 1 Le St . gal andar d To esa ih a prma f ci ca e of obvi nes t pa t c l ng t paen mus t bls i a e s ous s, he ry halengi he t t t pr by cl ra c nci e de e t taperon ofor nar s l i t a twoul ha bee ove ea nd onvi ng vi nc ha s di y kil n he r d ve n mo i t d t combi t t chi oft prora'r e e st ac eve t cli d i ton, tva e o ne he ea ngs he i l ef r nce o hi he a me nven i t a t ts i a ts n woul ha had a r a ona eexpe t ton ofs ces i doi s Pr t r& nd ha a d ria d ve e s bl c ai uc s n ng o. oc e Gambl Co.v.Te a Phar USA,l . 566 F.d 98 994 (7d.Ci.2009) Unde nni t s e v m. nc, 3 9, le r . pi ng hi lga i r aef gr offcua tndi ( t s andc e oft prorar;( t e l nquiy r our oups a t li ngs:a) he cope ontnt he i t b) he lve ofo dnays ili t eat ()te dfee c sb t e t ecame s be tmatra d t e e l r i r kl n h r; c h ifrn e ewe n h li d u j c te n h pro at and ( s c r c i rtons ofnon- ous s ,s ascommeri s ce s ir r' , d) e onday onsdeai obvi ne s uch cal uc s , l f tbu uns ve ne ds a f l e ofot r ' Dysl l if be Gmbb v C HLPatik ong-el t ol d e , nd aiur hes. l ar kxtlar n l. rc Co. 464 F. 1 , 3d 356,1 ( d.Ci.2006) Gr 360 Fe r , . aham v.John Dee e Co. 383 U. 1 1 1 r , S. , 7- 8 (l 66) tl a pae cha lnge ma a prma f ci s n of obvi nes ,t owne ma 9 . if tnt le r kes i a e howi g ous s he r y r butba e on S e sd unexpe t d r s t 'by dem ons r tng 'ha t cl i e i c e e uls t a i t t he a m d nventon e bis s e i xhi t om S ror Pr I Or a t e t t a pe s of or nay s l i t r lvanta twoul ha upe i OPCV dvan ag ha r on di r kil n he ee r d ve 4Th Cour notst m a oft s f t ar notdiputdby t pa teshe e.Fori t nce t pa tesdo n e t e hat ny he e acs e s e he ri r nsa . he ri ot diput whehe a oft cie r e e esconsiutspro a ta donotdiput t ta1 proral i t sca e s e t r ny he td efr nc tt e ir r nd s e ha l i ' n hi s t e sedasofJ e27,200 (. t ç ii dae'oroney rbef et pat applcai atis e wer xit un 4 ie.he krtcal t.' ea or he ent i tons s u e s b te ) l a dio t ep ris e p rso f rs bsa tal smi rd fnto so ap ro o o d n r s l i t e u mi d . n d t n,h a t ' x e t fe u t nily i l e i iin f e s n f r i ay ki n h t i e a l ar.Ther or t Cour fndst tape s ofor na ys l i t a.ha eih agr t de e i phanna utcal t ef e.he t i ha r on di r kil n he l s ter aduae gr e n t ce i s enc orar aeddici iewih a las t ye sofexpere e i pha ma tc devel ntorphysc ci e elt s pln t t e t wo ar inc n r ceu ial opme ial c mity, aler tveypos e s aba l ' de e i one( mor )oft s fel wiha l ttv yeas he sr or t nai l s s es cheors gr e n or c he ame i ds t t eas i e r ofexpe inc i pha re e n nmac tc dev opmen orphyscal m it . euial el t i che so 9 f ound s r ii orune ce '' Pr tr& Gambl Co. 5 F. a 994 ( i I r Soni uprsng xpe td.' oce e , 66 3d t quotng n e s 5 F. 746,75 ( d. r 1 ) 4 3d 0 Fe Ci. 995 . I KS lt Co. .T lje , n .5 0U. 3 8 4 7( 0 7 ,h S p e Co r rj ce a n R n 1 v eelx I c, 5 S. 9 , 0 2 0 ) t e u rme u t ee td rgi a i ai oft t c ng,s esi orm otva i t s,a r a fr d t tt Gr i d pplc ton he ea hi ugg ton, i ton e t nd e fime ha he aham f t sS ntnue t de i t i r t tc r s'a obvi nes a l i. Ne t l s t acor i i o fne he nquiy ha ontol' n co ous s nayss verhees , he Cou ta nowldg t i r ck e ed he mporanc ofi iyi ' r as t twoul ha pr p e aperon t e dentf ng : e on ha a d ve om t d s of or n y s l i t r l nt fe d t c bi t elm e s i t wa t cli d ne di ar kil n he eeva i l o om ne he e nt n he y he a me w i n i doe . The ef e,li r i ne es a y t i ntf s nve ton s' ' r or k ema ns c s r o de iy ome r as t twoul ha ld a t e on ha d ve e che s t modiy a k mit o f nown c ompound i a pa tc a m a r t e t ih prma f ci n riul r nne o sabls i a e ob ous sofa ne cli e c vi nes w am d ompound.' Take C'e l . Lt v. pha ' da h m. ndus, d. Al phar #/ ,49 m y. 2 F.d 1 3 350,1 ( d.Ci.2007) l ad ton.t KSR Cour hed t ta i nton ma be 357 Fe r . n dii he t l ha n nve i y f ound o ousi i woul ha be n i oust ty. KSR,55 U. a 42l A pa e cai i bvi f t d ve e s obvi o r ' ' 0 S. t . t nt l m s o oust ty i l he e i a desg ne d or ma ke pr s e t s ve a pr e a t r ar a bvi o r fû r s t in e r t es ur o ol oblm nd he e e fnie numberof i tfe pr dit bl s utons'a pur ui oft e s utons ûlads t t it den ii d, e c a e ol i ' nd s t hos ol i ie o he a ii t d s c s' l ntc pa e uc es . d ' Thus snceKSR, heFe r Cicui ha e ,i t de al r t s mphasz t tC edit biiy i t t hsone ied ha t c a lt s he ouc t pr o obvi ne s' De y Spi .I v Me r c u :ll Dane l ,567 F. 1 4,1 f ous s . pu ' ne nc. . dtoni s zlr k/ k, nc. 3d 31 326 ( d.Ci.2009) igrhe' e ca er ul'dic s i KvR r fr notonl t t expe t i Fe r . t-l prditbl es t s used n % ees y o he caton t tprora telm e s a e ca bl ofbe ng physca l combi ha i r e nt r pa c i i ly ned,butalo t tt c s ha he ombi ton na i woul ha wor d f isi e d ve ke or t ntndedpur e. / (ntr ctton omit .l t i tntc s pos ' J. i enal iai ' ted) n he nsa a e, t it nde pur e of t cai he n e d pos he l med i n i ns was t c e e a bupr on f mul to wih nve to o r at opi or ai n t i ove sabiiy ove t pror a t bupr on h oc orde f mul tons The e o e, f mpr d t lt r he i r opi ydr hl i or ai . r f r or W a s t es a i h t tt as e t d pa e c a m s a e obvi ,W a s m us pr by cl rand t on o t bls ha he s r e t nt l i r ous t on t ove ea convi i e denc t t a or na iy s le aria i 2004 woul have bee motvaed t ncng vi e ha n di rl kild ts n n d n i t o c ombi t pror ar r f r e t ac e t cl med i ntons i t s c e a c r ld ne he i t e e enc s o hive he ai nve i n hi as ontole r e s oronc a da bupr on hydr omi f multo a t t s i a ts n woul have ela e e- - y opi obr de or a i n- nd ha ad ria d ha a r as bl e d e ona e xpec ai t t a bupr on hydr r i f mul ton woul a hive t tton ha opi ob om de or a i d c e he a ii td s c s i t sc s gr a e sa lt ove bupr on hydr hl i f r a i . ntcpae uc es n hi a e e t r tbiiy r opi oc orde o multons J.Waton hasnote t ls d aprmaj cec s o b i u n s s sab ihe i à i a e fo vo s e s , Ta n it a c ki g n o c ountt Gr he aham f c or ,t Cour tnds t tW a s has no m a t a t s he ti ha ton t de he r quie s e r d howi Spe fcal W a s hasnotpr d by ce a c nci e de e t ta ng. cii ly, t on ove lar nd onvi ng vi nc ha pe s ofor na y s l i t a ti 2004 woul ha had a r a ona eexpe t ton t tc r on di r kil n he r n d ve e s bl c a i ha hangi ng t s t i a bupr on f multon fom hy ochl i t hydr om i woul r ul i he al n opi or ai r dr orde o obr de d es t n i r a e s a lt nc e s d t biiy. As a ge r lr e s ts eci i a unpr c a e ar. Num e ous prora tr f r e ne a ul, al el ton s n edit bl t r i r e e enc s prduce a tils o d t ra uppor t sprncpl ( e Def Ex.1 a 20550 (t r ')( e i as t t hi i i e. Se . 32 t d ge' Selctng al Be f m t te bist desr c nain ofpr tes i a difcul smimpiia choie.; or ha xhi t he ied ombi to operi s fi l e e rc l c l De . 1 3 a 2 7 7(i ud' (a l De. 1 6 a 3 3 48(s g e )(a ) De . f Ex. 7 t 0 3 i l' sme ; f Ex. 6 t 68 0 û hlf' s me ; f Ex. Go ) Bi 3 a 7 45 t 40703 (b vis' (i hee i ye,no rla e way of prdi i exa ty wha efc f e') k- r s t Da r eibl e ctng cl t fe t ' f ) t 4 c hangi t s tf ng he al onn ...wilha on is bi ogi la tviy ....' ;De .Ex.383 a 7931 l ve t ol ca c i t (t r k' (t o t tl t r i n rla ewa ofprditng t i l nc ofa patc a û bee ' s runaey, hee s o eibl y ve ) unf e ci he ntue e riulr s l s e iso t eb h vo o tep rn c mp u d.l P .Ex 8 a 1($ a k' (kl h a ii at p ce n h e a ir f h ae t o o n ' ; l . 2 t $ c ' k-l e blt ' Bl ) gy t pr c whih s tf mswilha desrbl pr risi e s ilynonexit t' . o edit c al or l ve ia e opete s sental sen.') l W a s ha not c t d t a w ine s t tm ony orpr orar t t c r c s t s g ne a r e,a t on s ie o ny t s es i i t ha ontadi t hi e r l ul nd whie W a s ha cie s ve a p i a tr f r est tr f rt b opi r l td c l ton s t d e r l ror r e e enc ha e e o upr on-e ae ompounds , n wih t e pton ofBilnghur tadd es t is 01sa lt Thus W a s r i o t one t he xce i li s r s he s ue ' tbiiy. , ton eles n he ra . kt esiid ha t tmony ofispha ma eu i e r,Dr Gr m Buc on. Atti lDr Buc on t tfe t t esi t r c tcs xpe t . aha kt t pro a ts ese movi t a bupr on hyd obr i f multon asa wa t s ve t he i r r ugg t d ng o opi r om de or a i y o ol he known sa lt pr emswih bu opi hydr omi l m ultons Dr Buc on cie s ver t biiy obl t pr on obr de br a i . . kt t d e al p i a tr f r e i s r or r e e enc s n uppor oft s c l i t hi onc us on. The frti a 1 publcai by Phii L.Goul tte i l Selc i ofBasc Dr ' is s 986 i ton lp d ild, k t e ton sa i ugs' (i d' .( f Ex.1 . Goul conti a c r wih t e s si f i ovi t kGou1 ' De . ) 73) d ans ha t t hre ugge tons or mpr ng he d' is ugge i s o educehyg os opi iy r c ct sa lt ofas l. ( f Ex.1 a 207 ) Goul sfrts ston i t r tbiiy at De . 73 t 47. ul c r by i r sng t ac d' nc ea i he i shydr ophobi t a usng a c boxylc a d i t a of a s phoni o ciy nd i ar i ci ns e d ne al i al, s eds ve , ha obr de s m i r l a i I i undi put how e r t t hydr om i i a m i r ac d s t not a ne a c d. t s wa r he ca boxylc acd s t s t s t a ng m a have a ualy diece one a y fom t r i i als o hi e chi y ct l r td h obr de.( ilTr 442:8- 1 ) ydr omi Tra . 1 443:0. Goul ss ond s gesi f ri pr ng sa lt i t us a a i wih a hi rpKa t d' ec ug ton o m ovi t biiy s o e n c d t ghe o r duc t a i t oft ac ous s uton. l i undiputd.howe ,t athydr omi ac d i e e he cdiy he que ol i ts s e ver h obr c i s oneoft fw a dswih alwe pKat n hy ochl i acd (nd woul t i ras a diy) he e ci t o r ha dr orc i a d hus nce e ci t , s t sta hi ma as have diece one away fom t h obr de. ( .Ex.1 a o hi e c ng y lo r td r he ydr omi Pl 03 t 1 3 ,TralTr 443:6- 1 ) 03.49' i . 1 444:3. hr Goul s t r s esi i t r ie t m etng poi of t s l. A s one of t ee d' hid ugg ton s o a s he li nt he a t pos i ltes f doi s he s gessc sbiii or ng o ug t hoosng a s l coun e i lsi t c orde and t i ma l t r on, itng he hl i he br de as e m pl . l a 2003 ve son oft s m e c r r oduc d by P.Henrc St hl omi xa es n ri he a ha t epr e i ih a , howe r t br dei i no l rr frnce asa e mpl ofais l countri ' ( f ve, he omi on s onge eee d n xa e tmal e on. De . ' 1 a 20598. Atti lDr Buc on c d ofe no expl ton f t s eque omison 30 t ) ra . kt oul f r anai or he ubs nt s i oft br de i fom t Goul cha t nordi he e ai whyhec et r y on t out t d he omi on r he d r, d xpl n hos o el he da e l ve son oft Goul c t r t rt n t 2003 St veri t twa c e 986 r i he d har, a he ha he ahl son ha s ont mpor ne a ous wiht tmeoft i nton.( i Tr 74:9- 1 ) t he i he nve i Tral . 1 76:7. l a ton,Goul ss gesi t r s t meli poi oft s twoul notl d t t n ddii d' ug ton o aie he tng nt he al d ea o he s lc i o a hy obr i asam e nst i ove t sa lt ofa hy ochl i s t be aus ee ton f dr om de a o mpr he t biiy dr orde al, c e t r a i meli poi s ofc orde a br i s a e notpos i e t pr c . Fo e mpl he eltve tng nt hl i s nd om de r sbl o edit r xa e, lt um br de a s um b o i ha l rm etng poi s t n t i c orde c ani g ihi omi nd odi r m de ve owe li nt ha her hl i ont i n c e pa t; con r e ys a moni m br i has a hi her m etng poi t n a oni ountr rs ve s l m u om de g li nt ha mm um c o i e. M or ove ,bupr on hydr omi a ualy hasa l rm etng poi t n bupr on hl rd e r opi obr de ct l owe li nt ha opi hydrchl i ( . 94a 1 ) o orde. P1Ex. t 3. Thus none oft s si i Goul woul ha ld a or na iy s le a ts n i , he ugge tons n d d ve e n di rl kild ria n 200 t r a ona y e ct t s t hi fom a hy ochl i t a hydr om i woul 4 o e s bl xpe hat wic ng r dr orde o obr de d i ove s t sabiiy. I f t Goul s s ggesi ma ha a t ly ld on a mpr al t lt n ac, d' u tons y ve c ua l e e way fom r ch i ahydr om i t s vet known sa lt pr em wihbup o on hydr hl i oosng obr de o ol he t biiy obl t r pi oc orde. The s c e ond pror a tr f r nce ct d by Dr Buc on i a 1 i r eee ie . kt s 996 publc i by Lyl D. iaton e Bihe tte ,S atF r o Dr g a d Ab o in'(k g lf'. ( f Ex.1 6) Alh u h g ly i d k l o ms f u s n s pt ' i he ) De . l s o Bi 6 . to g Bi e tac t ts l s e i i adifcul choie () .Ex.1 a 36830 ,Dr Buckon ghly e hes ha at elcton s fi t c Ief 66 t 48) , t cie Bi ey a ti a pur re y c a ni a r as t s e t bupr on hydr omi t td ghl t ral s po tdl ont i ng e on o elc opi obr de o i ove sabiiy ofbupr on hy oc orde f multons ( i Tr 99: 25. l patculr mpr t lt opi dr hl i or ai . Tral . 3- ) n ri a , Dr Buc t poi ed t t f l i s a e e unde t he ng Pr r ton of Ot r M i r l . k on nt o he olow ng t t m nt r he adi epa a i he ne a Acds: S i ala ds o he t n hydr hl i s h as s f rc,phos i a hydr omi i i ner ci t r ha M oc orc, uc ulu i phorc, nd obr c, ha be e oy p i i ly t r duc hy os opi iy a pe ha t a diy ofa r uli ve en mpl ed rncpal o e e gr c ct nd r ps he ci t es tng s uton. ( .Ex.1 a 3683080. ol i ' Def ' 66 t ) 1 3 Thi s to howe r conti no dicus i ofsa lt Ra he ,sa lt i a e s d s eci n, ve , a ns s son t biiy. t r tbiiy s ddr s e i t f l ng s ton,an whie t s ci mentons s ve a pos i e optons t i pr n he olowi eci d l hat e ton i e r l sbl i o m ove sa lt usngahydr o des ti notoneoft tbiiy, i obrmi al s hem.( f Ex.1 a 3683080. Furher e, Dc . 66 t ) t mor gi n t Bilnghurtha a r a t sed a numbe ofbupr on mi r lacds al t no t ve hat li s d le dy e t r opi ne a i , bei t he hy obr i , a f dr om de nd ound a1 of t 1 hem t be u t e, Bi e s sat nt a o nsabl ghl y' t eme bout r duc ng e i hygr c ciy by usng Ot rm i r la dswoul pr deltl gui ncet a or na iy s le os opi t i he ne a ci d ovi ite da o n di rl kil d a ts n i 2004 l ng t s vet known sa lt pr e swih bu opi hydr hl i . ria n ooki o ol he tbiiy oblm t pr on oc orde M or over t r a i hy os opi t ofchl i a br de i notpr ct e. l e , he eltve gr c ciy ordes nd omi s s edi abl n s ome c s s br i a e mor hygr copi t n chl i 'i ot r c es chl i ar mor a e om des r e os c ha ordes n he as , ordes e e hyg os opi t n br des and i sil o he ca e . t y a e c pa abl Fo exa e, r c c ha omi ' , n tl t r s s he r om r e. r mpl pot s i b om i i mor hyg os opi t n pot s u c orde,whieon t ot rha lt um a sum r de s e r c c ha as i m hl i l he he nd ihi brmi i mor hygosopi t lt um c oi ( f Ex.94at1 ) And i t Ha di and o de s e r c c han ihi hlrde. De . 2. n he r ng Ba tnr ee escie by Dr Buc o ( dic s d mor t oughl bel ,hydr omi s si efrnc td . ktn and s use e hor y ow) obr de andhy ochl i aes dr ordes r hownt bec o ompaa e notdif e ,i tr ofhyg os piiy.( il rbl, fernt n ems r co ct Tra Tr 78: 1 81: 1. . 2- 2 ) Bi e a s pr de a de i i te t gui f m ult s i s e tng a s t bl s t ghly lo ovi s c son r e o de or a or n elc i uia e al. ( f Ex.1 a 3683076. Thede sonteei c t t ti c ca i t lt i enc eed De . 66 t ) cii r ndiaes ha f hemi l nsabiiy s ountr i ami r lacd s t a c l gor t whih hy oc orde a hydr om i bel n ne a i al a e y o c dr hl i nd obr de ong t pah t he t o f l i t ma a ogani s l,nott ty a he mi r a d s t ( .Ex.94 a l l Tra olow s o ke n r c at o r not r neal ci al. Pl t 5- 6; il Tr 446: - 24. l f c ,Bi ey t c s t t m i r l a d s t pr ce a mor hosie . 23 447: ) n a t ghl ea he ha ne a ci als odu e tl envionme a t t bels sa e t n a s f t orc r r nt nd end o es tbl ha ulonae aboxylt s t ( .Ex.1 a ae al. Def 66 t 368306 3683067. Thi i c it nt wih Goul s tac ng t t i tbiiy du t 2, ) s s onsse t d- e hi ha nsa lt e o hygos opi t s d bea e s bytyi acaboxylcacd (n or ni a i . ( .Ex.1 r c ciy houl ddrsed r ng r i i a ga c cd) Def 73 a 20747. Thus not ng i Bi ey s ess t t a hydrbr de f t ) , hi n ghl ugg t ha o omi onnulton woul be ai d r as bl expe t t i pr ve t sa lt ofahydr hl i f m ulton. e ona y ced o m o he t biiy oc orde or a i Dr Bu on alo ct d t a 2000 publc ton by Ri ha d J Ba tn,butt sprora tofe s . ckt s ie o iai c r . si hi i r fr no gui nc on how t i ove t sabiiy of a hydr orde s t lt a one bupr o da e o mpr he t lt ochl i al, e l opi n hy oc orde.( f Ex.1 ) Thefnalprorar rfr ectd byDr Buckt ass si dr hl i De. 76. i i t eeenc ie . on ugge tng t ty bupr on hydr omi t s ve t known sa lt pr ems wih bu opi o r opi obr de o ol he t biiy obl t pr on hydr hl i i U. Pae No.6,1 940,fld May 1 1 (he'ladi pae ') ( f oc orde s S. tnt 1 0, ie 7, 995 t tlr ng tnt'. De . Ex.l ) l hi e r rpo t Dr Buc on cie ladi f is pur td tac ng t ta 38. n s xpe t e r, . kt td ' r ng or t pore e hi ha l h obr de s l ofa i e c ydr omi at n ndol ompound wa sa e whie t hy ochl i s l s ppos dl s t bl l he dr orde a t u e y wasnot ( f Ex.602 a 31) Atti ,howe r Dr Buc on wasf c d t c de t tt . De . t . ral ve , . kt ore o once ha he Har ng patnti fc tughtt tt ndol hy ochl i s twassa e. ( ilTr 78: 1 di e n at a ha hei e dr orde al tbl Tra . 2 82: ) l an efor t e an t sa r i onssenc Dr Bu on a te t i i not 8. n f t o xpli hi ppaent nc it y. . ckt dmitd hat t s pos i e t pr di t t sa lt of bupr on hy obr de bas d on i or a i a sbl o e c he tbiiy opi dr omi e nf m ton bout t he sabiiyofdif e dr .( i Tr 8l25- 22. t lt fernt ugs Tral . : 82: ) annot pr di how t sa lt of bupr on e ct he t biiy opi D r Bu on t contnne t t one c . ckt hus i d ha f m ultons wilb a f c e by a cha i s l ba e on t c ngs a t t cores or a i l e fe t d nge n at s d ea hi bou he r pondi ng s ls of ot r d ugs Thata i s on i cons s e wih t m a pr o a tr e e s t tt ac at he r . dm s i s it nt t he ny i r r ef r nce ha e h t ts l s e ton i i r nty unpr di a e a i pa tc a swih t satm e ma i t ha at elc i s nhe e l e ctbl nd, n ri ulr t he t e nt de n he D a e r er e:Clhe e i ,a ye ,n r la e w a Of pr ctng exa ty w ha efec cha ng vi s ef enc b - r s s t o e i bl y edi i cl t f t ngi t s l f m ofa a tve dr wilhave on is bi ogia a tviy,a t s he at or n ci ug l t ol c l c i t nd he upposton t tt ii ha he s m e s l f m oft r a e pa entc pounds w ilbe ve i e cty t s m e w a m ay n be a a t or wo el t d r om l ha n xa l he a y ot corec . ( f Ex.3 at7 03. r t' De . ' 45 407 ) W a s ha ct d t no ot prorar r f r ess ton s ie o her i t e e enc ugge tng t ts t hi t s l fom si ha wic ng he at r hydr hl i t hy o o i woul r s l i a m or sa e bupr on f mul to W a s oc orde o dr br m de d e ut n e t bl opi or ai n. ton at mpt t ove c te s o r ome t si poran dei e y b a gui t tobvi nes ca be ba e on t hi m t t fcinc y r ng ha ous s n sd he a ia lt of hi t oughput s r ni a a m e ns t r pi y cr a e and t t many s ls a va lbiiy gh-hr c ee ng s a o a dl e t es at t onc Attil Dr Buc on t tfed t tgi n t a ia lt oft e hi h-hr e. ra , . kt esii ha ve he va lbiiy hes g t oughpu s e ns t cr e i 200 a pe s oror na y s l i t a twoul have i l d bupr on hydr omi i a n 4, r on di r kil n he r d nc ude opi obr de n s r n f atr t s tt s vet sa lt pr emswihbu o on h ochl i ( i Tr cee or lenae al o ol he tbiiy obl t pr pi ydr orde. Tral . 89: 1 ) 6- 3. Hi h-hr hput s r ni howeve ,doe noti ntf whi h s t ,i a a e s tbl g t oug c ee ng, r s de iy c als f ny, r uia e f a pa tc arpur e;r t r i sm pl i ntfeswhih s lsc n be f r e Afe s r e ng, or riul pos a he , t i y de ii c at a o m d. tr c e ni one woul silhave t r nu e ous t t on t r s tng s ls t de e mi t r i vi d tl o un m r ess he e uli at o t r ne hei ndi dual pr ris ( ilTr 409:8- 1 5'De .Ex.602 a 1 'M a s Dep.1 23- 71:3. AsDr ope te . Tra . 1 4 0:s f t 5, e 70: 1 1 ) . Ande s t tte e n i one us hi h-hr hpu s r e ng,whih Vaea di no us i is ron esii d, ve f ed g t oug t c e ni c l nt d t e n t de l e ofbupr on hydr omi ,one woul smpl be l twih $a bunc ofs t .... veopm nt opi obr de d i y ef t k h als You ten ha t sudy t msa t e' a l ofwor t r ' ( i Tr 409:8- 5. So h ve o t he nd her s ot k hee.' Tral . 1 410: ) wh l hi t oug ie gh-hr hputs r e ng woul have a l d onet c e e a t s m a s t atonc i c e ni d lowc o r at nd e t ny als e, t woul no havealowe one t r s d t l d o ea onabl pr ditt i vi lpr ris oft r s tng s ls y e c he ndi dua ope te he e uli at i a nc n dva e. l i f rti ra o t a te Fe ea Cic i h srj ce t ag me tt to vo s e s t s o h s e s n h t h d rl ru t a ee td he r u n ha b iu n s c n b b s d o tea alblt ofatrtefc tsig Se S n h,5 0F.da 1 8 (ee tn a e a e n h v ia ii y fe -h -a t e tn . e a o 5 3 t 0 7 rj ci g a gumen t ta cli e c r t ha am d ompou ma b f nd y e bund obvi s i one s le i t a tc d ha ou f kild n he r oul ve pr ed t e cli e c oduc h am d ompound a t n done r i t si t a s s wheher i ha t nd he outne e tng o s e s t t d he desr pr ris a i t ad r quii t t obvi ne s be as e s d ba e on wha wa ied ope te nd nse e rng ha ous s ss e sd t s 1 6 e cabiiy s he pr ditd a e ce bout t pr ris i a he ope te n dvanc of t tng) l ed,because pr dit lt i t e esi . nde t hsone ofobvi ne s t obvi n sa yssmus f uson whe he - b e on t pror ouc t ous s , he ous es nal i t oc t r as d he i a t t f vo abl pr ris oft cai i nton coul be r s bl pr c e i a nc r- he a r e ope te he l med nve i d ea ona y edit d n dva e of a t tng. Se i Ther f e t a lbiiy of hi t oughput s e ni i smpl no ny esi e d. e or , he vaia lt gh-hr cr e ng s i y t pr tveoft is ofobvi ne s oba i he s ue ous s . l i f rt e s me r a ons t t W a s s a gum e bas d on t alege populrt of t s o hes a es ha ton' r nt e he l d a iy a or y e ons o he ac ha hydr r i s i 200 m us alo f l A s l ma be populrf man r as ,s t f tt t ob om de n 4 t s ai. at y h obr de ma have bee t t r mos c monl us d s l i 2004 wihou e a n ng ydr omi y n he hid t om y e at n t t xpli i w/ i wa s pr l t i smpl not pr a i as t whe he a bupr on hydr omi ? t s o evaen s i y y ob tve o t r opi obr de f onnul ton woul ha be n r a ona y e c e t i pr ai d ve e e s bl xpe t d o m ove t sa lt of bupr on he t biiy opi hydr hl i f r ultons. oc orde o m a i Ac or ngl t Cour tnds t t W as ha not pr d by cla a c nci c di y, he t i ha ton s ove e r nd onvi ng e d e t ta or na iy s le a ts n i 2004 woul ha r s bl e vi enc ha n di rl kild ria n d ve ea ona y xpeced a bu opi t pr on hydr omi f nnulton t ha i oved sa lt ove t bu opi hydr hl i obr de o ai o ve mpr tbiiy r he pr on oc orde f m ul tons Thus W at on ha notesabls a prm a f ci ca e ofobvi nes . or a i . , s s t ihed i a e s ous s J S c n ay c n ie a in s p r ahn n t n n o vo s es . e o d r o sd r to s u po t dig ? o - b iu n s f Eve as umi ar ndo, ha W a s ha e t bls d a prm af ci ca eofobvi nes , n s ng, gue t t ton s sa ihe i a e s ous s t Cour fn t tVa e ntha i toduc d s fc e evi nc ofune c e r s t t r but he t i ds ha l a s nr e ufii nt de e xpe t d e uls o e s has uc howi The e de e a ng. vi nc dduc d a ti de e t ral monsr t t tValan ' cai taed ha e ts l med i ntons nve i ha sgnii nt une ve i fca xpece a nt es ove t bupr on hy ochl i f multons td dva ag r he opi dr orde or a i , i udi al r( ncl ng onge doubld)s flf,r e rs ofs zues t a lt t f mult a sngl e hel ie educ d ik ei r , he biiy o or ae i e tblt a a1 dos ge srngt (ncudi t hihes dos e) i oved r itnc t dos a e t l a te hs i l ng he g t ag , mpr essa e o e dumpi a e irma acurbiiyduet rduce c r i t ( ilTr 31 1 322:3. ng, nd ase nuf t a lt o e d orosviy. Tra . 0:6- 1 ) W a s a gue t tVaea ha f ie t de t on r s ha l nt s al d o monsr t t r quied nexus bewe t e tae he e r t en hes une xpec e r s t and t as e td pae cli . The Cour tndst s a gumen t be wihou t d e uls he s re t nt a ms ti hi r to t t mert A ne doe notr quie t t a c am expr sy r ie t adva a s oft pae e i. xus s e r ha li es l ect he nt ge he tnt d iventon;i i e n i t s nough t tt y tow die ty fom t i ha he l r c l r he nventon. Se Pr empton Devce ,I . i e e i i s nc v Min s t M iig & Mf .Co, 3 F.d 9 3 9 7( e . r 1 4 (dSllspthfau e . . . n e oa nn g . 7 2 2 0 . 0 F d Ci. 98 ) ç ( ae ic e t rs . ç do no pr ery beong i cl ms t s e f i ofwhih i t poi outditncty ...(hel t op l l n ai , he ol uncton c s o nt si l t c omposton ofma t whi h i pa e e notisadva a s l i en iel pr r ne rhels ,i ii ter c s t nt d, t nt ge . t s tr y ope , ve t e s n evaua i non- ous s f a c tt t ke i o a c l tng obvi nes , or our o a nt c ountadva a s towi die ty fom nt ge l ng r c l r t i nton pae td.) (nenalquottons omitd) Hee,t u xpe td rs t tow he nve i tne ' itr ' ai te . r he ne ce e uls l die l fom t paentd i ntons al ofwhi r lt t t novelc bi ton ofbu opi r cty r he t e nve i , l ch ea e o he om na i pr on hyd obr i a pha m a eutca e i e s t pr de c r ld r l s a once a da r om de nd r c i l xc pint o ovi ontole eea e nd -- y f m ultons of bu opi hydr br de. Thus t e i a nexus bet e t une c e or ai pr on o omi . her s we n he xpe t d a nt gesa t a s t d pa e cl i s dva a nd he s ere t nt a m . obvi ne s. n I a ton,ot r s conda y c i r tons s n ddii he e r onsde ai uppor a fndi of non- ous s l t i ng pa tc ar t r peaed f iur ofot s durng t t nt ye r f l ng Bilng r tt s ve ri ul , he e t al e her i he we y a s olowi li hu s o ol t known sa lt pr e swih bu opi hy oc o i s ggesst tt cai i he t biiy oblm t pr on dr hl rde u t ha he l med nventons i w oul not ha be obvi d ve en ous. Se Adv e ance D ipl ys S ' l v Ke St e Uni ,21 F. d s a yA , nc. . nt at . v. 2 3d 1 1 5 ( d.Ci. 272, 28 Fe r 2000) Mi Mi ng ( M. (' v John on & Johns Orho dis l . ; nn. ni Q f - . s g. 0. on t pe c , nc, 97 F. a l 75 (e s ng t t compett s'fiur t dev op t paentd i enton 6 2d t 574- r a oni ha ior al e o el he t e nv i s gge t no o ous s. Furhe e, t f t t t t ee ot r c u sed n-bvi nes) t nnor he ac ha hr he ompa e , i udi nis ncl ng W aton,hav c ed Aplnz n de pie t a ia lt of bu opi hydr hl i s s e opi e i s t he va lbiiy pr on oc orde uppors a t fndi ofnon- ous s eS ci t Compostsv QabotCor ,845 F. 981 991( d. i ng obvi nes.Se pe al y ie ' ' . p. 2d , Fe 1 8 Ci.1 (i ng t cli d i i r he t n one i t publc domai i i c tve r 988) f copyi he ame nventon, at r ha n he i n, s ndiai ofunobvi ne s') ous s . . ' 4.The Ptz r c s i di tn s e i e a e s s i gui habl At t c nt r of W a s s obvi nes c le he e e t on' ous s ha lnge i is ar um e t t t s ca e i s t g nt ha hi s s c n r le b P e,I c v A tx I c,4 0 F.d 1 4 ( d. r 2 07 . Th p tn e a n r o told y fz r n . . poe , n . 8 3 3 8 Fe Ci. 0 ) e ae t x mie wa ma ee p e sya r o te P e c s dui gp osc t n O te p tn si s i, o v r s d x rs l wae f h hz r a e rn r e ui f h ae t n ut h we e , o a c l de t tt f t ofPfz rwe ever dif r ntfom t f ct i t sca ea t r or nd onc u d ha he ac s . le r y fe e r he a s n hi s nd he cf e irlv t t prs ntpr e n .( f Ex.80at00078 )'heCour a r e . ree anto he e e oce digs De. 3. l t ges l f e t asetd pae cl msalr aedt a odopi be ylt,whihwa ceae n sz r he s re tnt ai l elt o ml ne s ae c s r td t s ve t k o ol he nown sabiiy pr ems wih a odopi m a e t I at 1 54. The Fe r t lt obl t ml ne l a e. d 353de al Cic tf r ui ound t cli st be obvi i viw oft - ri a i ed f c s'oft ca e. I a he am o ous n e he t tculrz a t ' he s d. t pa 1 6 - 8. S le ty i P e te c u tf u d ta nu r u p ir atta h n s s cfc ly 3 76 ain l, n hz r h o r o n h t meo s ro r e c i g pe iial i c e t s t hi t t bes at s l w oul r s t i i pr d sa lt ove t m al a e ndi at d hat wic ng o he yl e a t d e ul n m ove t biiy r he et s t l a 1 6 He e howe r a dic s d a e, W aton ha ofe e no smia al. d. t 362- 4. r, ve , s s us e bov s s frd i lr t ac ngs s e hi ugge tng t ts ichi f om t hy oc or de s tt t hydr om i s t w oul s i ha w t ng r he dr hl i al o he obr de al d r s ti a m or s a e bupr on f m ul i Thus f t s a s ve a ot r r a ons t Cour e ul n e t bl opi or aton. , or hi nd e r l he e s he t ne dnotdic s r cri ditnguiha ea doesno c r hee. e sus, /z s si s bl nd t ontol r A c or ngl r vi w i t evi nce a c di y, e e ng he de dduce a t i i lght oft G r d t ral n i he aham f c or ,t a t s he Cour c ude t tW a s ha note t bls d by c ea a c nci e de e t V a ea ' t oncl s ha t on s s a i he l r nd onvi ng vi nc hat l nts cai d as e t p t tcai sa e i i f obvi nes . l me s red a en l m r nvald or ous s 1 1 C onc us on 1. l i Fo t r a o di c s d a r he e s ns s us e bove, he Cour fndst W a s hasf ie t pr by cea t t i hat t on al d o ove l r a c ncng e de t t Vala ' a s td paen cli a e i i Ac or ng y,t nd onvi i vi nce ha e nts s ere t t a ms r nvald. c di l he Co r wi e trj d me t i fv r o Vae n a d a ans W as n o Vae n ' cams o u t l n e u g n n a o f la t n g i t to n la ts li f l i ri nf ngem ent . r D ON E AN D O RDERED i Cha be s a M i m i Fl i t s n m r t a , orda, hi FEDE CHI E A , . Copi Pr de To: es ovi d Couns lofRec d e or 20 O da Of N o m be , y ve r O TED STATES DI STRI J CT UDGE

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