Valeant International (Barbados) SRL v. Watson Pharmaceuticals Inc. et al, No. 1:2010cv20526 - Document 158 (S.D. Fla. 2011)
Court Description: AMENDED MEMORANDUM OPINION. Signed by Chief Judge Federico A. Moreno on 11/8/2011. (mmz)
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UNI TED STATES DI STRI COURT CT FO R TH E SO UT H ERN D I STR I O F FLO RI A CT D C as No.1 20526- I - O R EN O e 0C V M V A LEAN T m TERN A TI N A L O ( BARBADOS)SRL, Pli tf , a n if VS. W ATSON PHA RM A CEUTI IS,I C. CA , N . W A TSON LA BO M TO RI l C, ES, N FLO RI ,a W A TSON PH AR M A ,I C. DA nd N A M EN D ED M EM O I N DU M O PI I N U N O Theproro ni wa i om plt a i t src a r plc wih t f l ng Or : i pi on s nc e e nd s hus ti ken nd e a ed t he olowi der Thi a ton was fl by Vala l enai s ci ied e nt ntr tonal( ba ) SRL (s e f' a ns Bar dos t an ) gai t val W a s Pha m a e ial,I ,W a s La a ore ,l ton r c utc s nc. ton bor t i s nc. Fl i a W a s Pha ma,l . orda, nd ton r nc (ole tvey,i as ',alegi paenti ngeme . Vaea i t owne ofsve a patnt c lci l k ton' l ng t ngi W ) nt l nt s he r e rl e s r ae t t dr k wn a Aplnz nl . W as s ekst mar tt gene i equi e oft t eltd o he ug no s e i ton e o ke he rc valnt ha d ug. W a s ha conc ded i rnge e butas e t a a a tr ai de e e t tVaea ' r ton s e nfi m nt s rs s n fi m tve f ns ha l nts a s re pa e sa e i ld. s e td t nt r nva i Aplnzi i an a i pr s nt t t c ans bu opi hydr omi as t e a i e nl s ntde es a ha ont i pr on obr de h ctve i e en . V al a ow ns f pat t r l t d t A pl nzi : U . Pa en N os 7, 61 ngr di t e nt our en s c a e o e n* S. t t . 569, 0, 7, 823,7,49, 1 a 7, 992(ole i y.'hepae si s f'.Ea h oft pae si 563, 6 0 9, nd 553- c lctvel t tnt-n-ui ) c he tnt-ns t c ai s ve alc a m s l or r t s r a ln t i s f t i l t pa te a e d t t y ui ont ns e r l i . n de o t c m i e he s ues or ra , he ri s gr e o r t s c s onl wih r s c t fve r pr s nt tve c ai s i t pa e s wih t r s uton oft hi a e y t e pe t o i e e e a i l m n he t nt , t he e ol i he is s c s ue once ni t e cai s beng dipostve a t al oft pr vi l as e td cai sas r ng hos l m i s ii s o l he e ousy s re l m bewe nt pa te .Ther es ai cai oft pat t-n-uiar ( )Cli 3oft 1 0 t e he ris epr enttve l ms he ensi s t e: 1 am he 61 pae ;( Cli 9 oft $ pae '( Cli 1 oft ; paen ;( Cli 2 oft $ 9 tnt 2) am he 823 tnt 3) am 0 he 823 t t 4) am , he 01 pae ;a ( Cl m 1oft 1 pae .Thcr prs nttvecli r aet contole r eae tnt nd 5) ai he 992 tnt e e e ai ams elt o r ld el s a onc a da f nd e- - y onnul tons ofbu opi hyd ob omi m ehods ofte tng de es i wih ai pr on r r de, t rai pr son t t ef hos onnul tons an a s c fcc ysa lne f m ofbupr on hydr om i ai , d pe ii r t li or opi obr de. TheCo r ha j rs ito o e tep risa dt es b e tmatrp ru n t 2 U. C. u t s u id cin v r h a t n h u j c te u s a t o 8 S. j e 1 a. Addii l ve i appoprae undc 28 U. C.jj 1 a 1 b) Net r 338() tonaly, nue s r it r S. 391 nd 400( . ihe j rs ito n rv n ei c n ctd b tep ris 'h Co r c n u td ab n htil r m J n uid cin o e u s o tse y h a t . l e u t o d ce e c ra fo u e e ' 21 2011t J 28,201l Thi M e a , o une . s mor ndum Opi on consiut t Cour' fndi off t ni tt es he t i ngs ac s a c l i oflw on t is r ie durng ti . Uli a ey, he Cour fndst tW a s nd oncusons a he s ues as d i ral tm t l t t i ha ton has f ld t pr ve by cea a c ncng e de e t tValan ' as e td paentcli a e aie o o l r nd onvi i vi nc ha e ts s re t a ms r iv ld a da c r igy, r nsj d me ti f v ro Vae n . n ai , n c o dn l g a t u g n n a o f la t 1 BA C K G R O U N D . Bupr on wa i t d b Na i n M eh a i 1 asa me hod ofte tng depr s i opi s nven e y rma t n 969 t rai e son a wa s e nty pae e by M e a i 1 4 i ( . Paen No.3,1 706 (he SMe a nd s ubs que l tntd ht n 97 n JS. t t 8 9, t k ht pae ) ( f Ex.1 ) W hiet Mehapae me i anumbe ofbupr on s ls idoe tnf'. De . 35. l he t tnt ntons r opi at,t s not s ii ly meni bu opi hydr omi ( .Ex.96 :!53-4.Tra Tr 437: pectcal ton pr on obr de. Pl 5 , il . 25438: 1) Buprpi ha bee s dsnc t 1 1. o on s n ol i e he 980sa t bupr onhydr hl i s l,unde t s he opi oc orde at r he brndna W elbuti ( .Ex.9811 Def Ex.602atl ) Toda bot brndeda genei a me l rn*. Pl 18; . 0. y, h a nd rc ve sons of bupr on hydr hl i a e on t m a ke , i udi gene i ve sons s d by ri opi oc orde r he r t ncl ng rc r i ol W as ( . 94a 86. ton. PlEx. t ) Si t e ry 1 nce he a l 980s howe r i wa known t tbupr on hydr hl i ha sa lt , ve , t s ha opi oc orde d t biiy pr e whe c ne wih phama eui lexcpint.( f Ex.1 a 20556- *De .Ex. oblms n ombi d t r c tca i e s De . 28 t 57, f 60 a 1 1 ) Bewee l 4 a 2004 ma atmpt wee ma t i ovet sa lt of 2 t 8-9. t n 98 nd ny te s r de o mpr he tbiiy bupr onhydr hlrdef opi oc oi onnultons ( i 'r 66:8- 25;3011 303:6.P1 Ex.94a 38. ai , Tral1 . 1 68: ' :0- 1 , . t ) One oft trt s at mpt wa a l he i s uch te s s 984 pa e applcai by Bilnghur twhe e he t se t nt i ton li s r etd s er ldif e bu opi s lst s ei a ha i oved sa lt r ltvet t hydr orde ev a fer nt pr on at o e f ny d mpr t biiy ea i o he ochl i s l.( f Ex.1 P1Ex.94a 38*De .Ex.379a 40832. Amongt s lsBilnghurttse at De. 28; . t , f t ) he at li s e td wee anumbe ofmi r la dsl a1 ofwhih wer f r r ne a ci - 1 c e ound t b unsa e. ( i Tr 473: o e tbl Tral . 2247 11) Aswa t c e i t Me apat t t hy ob o des l wa net rme i d nor 4: . s he as n he ht en. he dr r mi at s ihe ntone t t ( i Tr 66: 867:5. Onl t malat s l,whih i a or ni caboxylca d s l, esed. Tral . 1 - 1 ) y he e e at c s n ga c r i ci at wa f s oundt ha i ove sabiiy.( .Ex.602 a 1 1 ,TralTr 434: - 1 ) Duet o ve mpr d t lt Def t 8- 9. i . 21436:0. o t c ogy c e ns howeve,i c d ne be f mul ed i o a co oxiol onc r , r t oul ver or at nt mmeri pr t ( f cal oduc. De. Ex.1 a 205 .TralTr 435:0- ,M a s De 1 20- 3124. Durng t t nt ye r 28 t 57, i . 1 23* e p. 30: 1 : ) i he we y a s f l ng Bilnghur ts f ie at mpt t fnd a aler tve s twih i oved sa lt ove olowi li s ' a ld te o i n t nai al t mpr t biiy r bupr on hydr orde,no ne efo t wcr m a t tnd a dif r ntbupr on s t i t d, opi ochl i w f rs e de o i fe e opi al; nsea ot rm e nswe eex or d t i pr sa lt ofbupr on hydr hl i f multons s ver l he a r pl e o m ove tbiiy opi oc orde or ai , e a ofwhihwees eque l pae ed.( ilTr 66:8- 25)Def Ex.602a 1 1 ) c r ubs nty tnt Tra . 1 68: . t 8- 9. Des t t va i pie he rous at m pt t i ove t sa lt of bupr on hyd oc orde te s o mpr he t biiy opi r hl i f m ultons t s f lf ofc or a i , he hel ie omm e ci bupr on hydr hl i tblt ha r m aned s r, r al opi oc orde a e s s e i ho t wih onc a- f m ultons ha ng ne r a ev a s f lf l rt n ei t en m on hs t e- day or a i vi ve chi ed hel ie onge ha gh e t . ( il Tr 299: 300: ) Thus i 2003- Vaea (hen Bi i) st out t a e s t Tra . 23- 4. -n l nt t oval e o ddrs he l tndi sa lt is s wih bupr on hydr hl i f multons, ( i Tr 298: ongsa ng tbiiy s ue t opi oc orde or ai Tral . 20phae r l mpls ner ci als 'Hydr orde, h obr de.s f es a phos tsa ealexa e ofmi ala d s t. ochl i ydr omi ulat . nd re fe e t 299: 303:7- 380:6- ) W hie V aeant tid a number of dif r nt approaches, i 20; 1 22; 1 21. l l uli t y de de t r vii wha Bilnghurtha at mpt d butf ie t dicove i l tmael ci d o e st t li s d te e a ld o s r n 984 a ne bupr on s l t tc d be f m u ae i o a c me cilpr twih a e ende s l w opi at ha oul or l td nt om r a oduc t n xt d hef l e ( 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 rj c s o xe d h h l ie f f W elbuti wihoutne tvel i ci a ofisot rpr ris ( ilTr 307: 8. l rn* t gai y mpa tng ny t he opete . Tra . 5- ) Thefrtse i t prj c wa t lgur ou wha s t ofbupr on c deve bema is tp n he o e t s o i e t t als opi oul n de. ( sDe Tr64:5- 6. Mae p. . 1 1 ) Be aus V a e w a not s i i d i m a a ur ng ne s t ,i c e l ant s pec alze n nuf ct i w als t s ughtt asit eofa Iainche c c o he ssanc n tla mial ompa knownasChe S. A.Cù mi'.( a ny mi P. Che ') M es De Tr 64:5- 6. Vaea and Che s nts ve a mont at i t ma ne sls p. . 1 65: ) l nt mi pe e r l hs temptng o ke w at, ma ofwhih fie t r ul i atsabl pr ct ( f Ex.95;Def Ex.98. Thers e ton ny c ald o es t n e t e odu . De . . ) i elci of s lswasl r l a empii alpr es ,be us i wa difc tt pr c e ty whih s t at a ge y n rc oc s ca e t s fiul o edit xac l c al woul bet be t ( a De 8 2- .1 23 1 11 ) d he s. M es p. 4: 6- 70: - 7 :3. l 2004 t i n he nvent s fom Vaea a Chemim a bupr on hydr omi The or r l nt nd de opi obr de. y dic r d t bupr on hydr omi e ssi many f m s bot a phousa c ysalne s ove e hat opi obr de xit n or , h mor nd r t li . ( f Ex.604 a 1 P1 Ex.96 a 1 7ra Tr 6 1 25)671: 1 ) Among t e f ' was De . t 0; . t 5; -il . 43:62- 5. hes ol ms t v y sa e c ysali compound For Ibupr on hy obr de c r d by Cl m 1of he er t bl r t lne m opi dr omi ove e ai t $ paent ( ilTr 224:6- 8. 'he i nt sas tsed bupr on hydr omi he 992 t . Tra . 1 225: ) l nvc or lo e t opi obr de and dic r t t bupr on hydr omi i a contole r e e f mul ton pr s ove ed ha opi obr de n r ld-elas or ai oduce a s muc m or sa e pr ct r a i t core pondi bupr on hydr hl i f mul i . h e t bl odu eltve o r s ng opi oc orde or atons ( i Tr 311: 31 8;Pl Ex.95 a 01 l 1 Tral . 18- 2: . t 53 9, 54331. The as dic r t tbupr on ) y lo s ove ed ha opi hydr om i onc a da t bl t c be f m ul e a a1 t r c m e d d l dos ges e n obr de e- - y a e s an or at d t 1 he e om nde aiy a , ve t hihes dos ,whi had ne rbe a compls d wih bupr on hydr orde. ( il he g t age ch ve en c ihe t opi ochl i Tra Tr 31 25- 6:3'Pl Ex. :34. . 2: 31 1 , . 98 ) Asar s l o t i rs ac p oe t Vae nt sa l t d v lpApe zn ao c - -a e ut f hs e e r h rj c, la wa be o e eo ln i *, n ead y bupr on hydr om i tbl tc r d by t pae si s t The efec i fln da e oft opi obr de a e ove e he t nt -n- ui. f tve ii g t he pae si s ti J 27,2005. Vala lunche Apl i i Aprl2009. Le st a ye tnt-n-ui s une e nt a d enznl n i s han ar ltrW as s htFDA a ova t m a ke a ge rcve son ofAplnzi whih W a s has ae ton oug ppr l o r t ne i r i e nl, c ton c e i rngest pat t-n- ui. The et e t e s e is e f ti wa whehere h oft onc ded nfi he en s i s t r br . h ol s u or ral s t ac he as e t d cl i s i t f pa e s i s ti i ld. s re a m n he our t nt - n- ui s nva i I .D I U SSI N l SC O i pae s lbe pr ume vai ' 35 U. C.j 282. By saut t pae si s t k tnt hal A es d ld. ' S. tt es he tnt-n-ui tha a sr pr s s ve tong e umpton ofvaldiy i i rng ntpr e di . Alsie Cor v.VSll ' i i t n nfi eme oc e ngs' - t ' p. ntl , l . 1 F. 1 08,1 ( d.Ci.1 . Thi pr umpton ofvaldiy a isi pe nty nc, 74 3d 3 323 Fe r 999) s es i i t pple nde nde l t e c cai wihi apat t e n i ot camswihi t pae aehel i ld.35U. C. o ah l m t n cn, ve f her li t n he tnt r d nvai S. j 282.Ac r ngl W as mus pr i i t f e ch a s t cl m . co di y, ton t ove nvaldiy or a s ered ai To ove c r ome t pr s he e umpton ofva i t t cha lnge has t bur n of pr ng by i ldiy, he le r he de ovi r . 4 Lt Pa te s i cea a c nci e de e t t paen i i i M i os .h Co p.v i i d. rn r hp, l r nd onvi ng vi nc hat he t t s nvald. cr o l S.Ct 2238,22 ( l.Cl ran c ncnge de ei e de t tpl e i t fc 31 . 42 201 ) ea d onvi i vi nc s vi nce ha ac s n he a t fnde l n abi ng c ci t tt tut ofIhelfct c entons rs hihl pr bl. i rt a di onviton ha he r h t a ual ont i i) g y oba e' ' Col ado v Ne M e co,467U. 31 31 ( 98 (ntr quottonsomitd) igl t f t or . w xi S. 0- 6 l 4) i enal ai te . ûlf he ac tir of t is i l t unc ran,t pa t wih t bur l e ' Te h.Li nsng Cor v. re he s ue s ef e ti he ry t he den os s. c ' ce i p. Vi e ,l ,5 F. 1 6,1 ( d. deotk nc. 45 3d 31 327 Fe 2008 . Thi bur çsc tnta rmans ) s den i onsa nd e i i t o houtt s ton t c le er'a ' hr ug he ui he ha lng ' nd s doesnots f a a tm e t t paentowne . F# hi' t ny i o he t t r' ' L b . lc v Prf'Po iin r /c,7 4 l.d 9 5 9 1( e Ci.1 8 . Mo e v r wh nt a s, n . . o l sto e s / . 2 -2 6 - 7 F d. r 9 4) r o e, e he ? Pa e tOfi e ha consder d t p i a durng pr e uton oft pa e s t bur n on t t n fc s i e he ror n i os c i he t nt , he de he c le rt e t bls i ldiy i e hea er Gl Lt v Apotx,I ,376 F. 1 hal nge o sa ih nvai t s ven vi . axo d . e nc. 3d 339, 1 ( d.Ci.2004) I xLabs,l .v Av ntsPhar ,I ,468F. 1 1 8( d. r 348 Fe r ; mpa . nc . e i ms. nc. 3d 366, 37 Fe Ci. 2 . 006) Her ,W a s c le e t on hal ngest vai t oft tve r pr s nt tvepae cl m son t bass he ldiy he i e e e ai tnt ai he i t tt y ae ( )a ii td by t prorar;a or( obvi i vi oft prorar. The ha he r 1 ntcpae he i t nd/ 2) ous n ew he i t Cour wila e se c ar e i t n. t l ddr s a h gum nt n ur A .A nti pat on vi i W at on cont nds t t Cl m 3 of t ' 1 pa e a Cl m l of t : pa e a e he 6 0 t nt nd ai he 992 t nt r s e ha ai i ld f a ii ton unde 35 I. C.j 1 b)2 Ge ea l s e k n ,ç an ii to me n y g nvai or ntcpai r . S. J 02( . n r l p a i g t j tcpain a s t tt ca me i nton waspr vi l known.and t ta1 oft eemen sand lmia i of ha he li d nve i e ousy ha l he l t i ttons t c am sa e des rbe i a sngl prora tr e e e. Hakm v Cannon Av Gr p,PLC, he l i r c i d n i e i r efr nc ' ' i . ent ou 479 F.d l 1 1 9 ( Ci.2007) 't ii i rquiesa tndi t Sa a evey 3 3 3, 31 Fed. r . tAntcpatonl e r i ng hat e ch nd r lmiain i f i tto s ound et rexprs l ori rnty i asngl prora tr ee '' Sano 47 ihe e sy nhee l n i e i r efrnce.' f, 0 F. a 1 ( tng Cee ia Tec .Lt v Roc wel I 'Cor ,1 F.d 1 4,1 ( 3d t 375 quoi lrts hs d. . k l ntl p. 50 3 35 361 Fed. Ci.1 .Ani pai i aquesi off t EI lil drC(.p Zenih Gol i Phar . l , r 998) tci ton s ton ac. i -lv ) . t dlne ms, nc. 471F. 1 1 ( d.Ci. 3d 369, 375 Fe r 2006) . Fo a prora tr f r nc t a ii t a cli e i nton,t r f r e t us notonl r i r e e e e o ntc pae am d nve i he e e enc s t m y dicl eal elment oft cli wihi t f c ner oft document butm us a s di cos s os l e s he am t n he our or s he , t lo s l e t e elment a r nged a i t cai . Ne M o yl l .v Ve ii l . 5 F. 1 9, hos e s ra s n he l m - l ne N nc , rsgn, nc, 45 3d 35 ' 1 69 ( d. Ci. 2008) (nt na quottons (mitd) 'g-he r een mus ce l and 3 Fe r i er l ai l te . --l efr ce l t lary une voc l dicl et cai d gnv i ordiec t es ledi t a tt t gnve i qui aly s os he l me i entonl r t hos kil n he r o he i ntonl wihou an ne f pi ng,c t t y ed or cki hoosng.a c bi ng va i dicl ur snotdie ty r a e t i nd om ni rous s os e r c l elt d o 2Cl m 3 oft : 0 paen i diece t ani ove met ofteai depr son usngaoncea- bupr on ai he 61 t t s r td o mpr d hod r tng es i i - day opi hydr o i dos gef m .Cl m 1oft $ paen i diece t as ii a hi y sa ec ysali obr m de a or ai he 992 t t s r td o pecfc nd ghl tbl r t lne compound ofbupr on hydr omi - . m Ibupr onhydr omi opi obr de For opi obr de. e ch ot rby t t c ngsoft ct d r er nc ' l r Ar ly 59 C. P. 804,455 F. 586, a he he ea hi he ie ef e e.' n e k e C. A. 2d 587 ( C. A.1 . Any difr ebewee t prorar rfr nc a t cl me i ton, C. P. 972) feenc t n he i t ee e e nd he ai d nveni no m at r how si ,def t a a ii ton cha lnge t valdiy. Net one N,545 F. a te lght ea s n ntc pai le o it M yl 3d t 1 . A se a ne by t Fe r Cicui i Ne M one N : 371 xpl i d he de al r t n t yl Thus i i note ,t s nough t tt pror a tr f r nc di cl e pa tof ha he i r e e e e s os s r t cl me i nton,whi a or na y a ts m i s e e he ai d nve i ch n di r rian ght upplm nt t m ake t whol or t t i i udes m uli e,di tnc t ac ngs o he e, ha t ncl tpl s i t e hi t t t a ts n m i s ehow com bi t ac eve t cl i e ha he r i a ght om ne o hi he a m d i nventon. i I d. l ot r wor ,e e e s ofa cl i t a e notp e e i t s ngl pi c ofpr ora ton n he ds l m nt a m hat r r s nt n he i e e e i r whih t a i i ton def e i bas d m a notbe s i b t k c he ntcpa i ens s e y uppled y he nowldge ofone s le i e kild n t a tort dicl ur ofa t r r f e c. Se Sl uc ur Rubbe J'tzç Co.v Par Rubbe he r he s os e no he e er nc e r l al r rp . . k r Co. 7 F. 707,71 ( d. r 1 -s e J/' El Lil and Ct v SiorPhar . l ,705 F. , 49 2d 6 Fe Ci. 984) e A i l . o y p . c . ms, 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 l e nt l n nve i r a ii td,t c l ng pa t may notr y upon t knowldge ofone s led i t a tor ntc pae he halengi ry el he e kil n he r t dicos eofa he rfr ncet s ymisngee nt.) he s l ur not r ee e o uppl si lme s' . ' Hee,W as c endst tt 1 M e apae ( .Ex.1 )a i paesb hCl m r ton ont ha he 974 ht tnt Def 35. ntci t ot ai 3 of t i 0 pa e a Cl i 1 of t . pa e , t f me e es l and t lte he 61 t nt nd am he 992 t nt he or r xpr sy he at r i r nty. The Cou tfnds t tW a s has notm e t e ctng s anda d f a i i ton wih nhe e l r i ha t on t he xa i t r or ntc pa i t r espectt eiherpat cl m . o t ent ai 1 Cl m 3o he< ppatnti note pr s yantcpatd . ai ft 61 e s x esl ii e Cli 3 oft ' 0 pae i a de ndan cli whih i or or t by r e e t am he 6l tnt s pe t am c nc p aes ef r nce he e e e s of Cl m l of t t 0 pa e . W hen t t cl m s are i egr ed Cl m 3 r l m nt ai he 6l t nt he wo ai nt at ai eads as f l olows: A me hod of tea i de e son, c t r tng pr s i omprsng a nitrng a ii dmi se i n e f c i a ount of bu o on hy obr i i a o e daiy fe tve m pr pi dr om de n nc - l dos get te tde esi t as b e ti nee t r . a o ra pr son o u j c n d heeof ( .Ex.003 a 78 . Thus Cli 3r r t t bupr onhy obr dec iea Def t 6051) , am equics hat he opi dr omi omprs onc - iy dos ge f r . Ye i i undiput d t tt M eht paen con ai no dicl ur ofany e da l a om tts s e ha he a t t t ns s os e onc d l dos ge f m. ( f Ex.1 ) l e W as ha a te a s h i ispos-ra e-aiy a or De . 35. nde d. ton s dmit d s uc n t ttil flngs ( .No.1 at6. Thi aone prcl sa tndi t tCli 3 oft $ 0 pae i ii . Dkt 41 ) sl e ude l ng ha am he 61 tnt s e e sy a i i t d by t M eh apaen sast cai d i nton mus be i ntc l dicl e xpr s l ntcpa e he t t t he l me nve i t de ial s os d y i t cied pr ora tr e e n he t i r ef r nce. Ne M one N s5 l. a 1 1 t yl 45 '3d t 37 . W a s a gues t t Cli 3 i ne rhees e es l a ii t be aus once da l ton r ha am s ve t l s xpr sy ntcpaed c e - iy dosng ofbu opi wa we lknown i t proral by 2004 and t woul ti i pr on s l n he i ' t hus d fmmedi e y ha atl ve be e s ge by a pe s ofor nar s l i t a ti 200 r a ng t M e a 1 pa e . en nvia d r on di y kil n he r n 4 e di he ht 706 t nt' ' ( .No.1 a 5. Thi a g nt howe r i e cl t ki ofa g ntt thasbe n Dkt 41 t ) s r ume , ve , s xa ty he nd r ume ha e g. r u 2d , M yl rjce b teFe e a Cic t See,e. ,Stuct ralRubber,749 F. at716'Net one N,545 ee td y h d r l rui. F. a 1 . Acc di y,t Coul fnds t t t M e a pa e doe notexpr s l a i i t 3d t 371 or ngl he ' i t ha he ht t nt s e s y ntc pa e Cl i 3 oft k 0 pa e . am he 61 t nt 2 Cl i 1o he< # pae tï no i r nt a tcpae . am ft # J tn A tnhe e l n ii td ' y Cli 1oft 1 pa e i die t d t as cii a hi hl sa ec ysa lnecompound am he 992 t nt s r c e o pe fc nd g y tbl r t li ofbupr on hydr omi For lbupr on hydr om i W a s does notc end t opi obr de m opi obr de. t on ont hat Cl m 1oft $ patnti e es l a ii ed. Ra he ,W a s n' s e c lnget Cli 1 ai he 992 e s xpr sy ntcpat t r t o s ol hale o am oft : 2 pa e i t ti i t nhcr nty' a i i t by t M e a pa e . he 99 t nt s ha t s û i e l ' ntc pa cd he ht t nt U nde t docti of i r ntantci ton,a pr or a tr f r e t t doe notexpr s l r he r ne nhe e i pa i i r e e enc ha s e sy di c os a pari a e em e ofa c ai ed i nton m a ne t l s a i pa e k ft tm i s ng sl e tcul r l nt lm nve i y verhe e s ntci t k ha s i i c r t r s i i nec s arl pr s nt or i r nt i t s ngl antci tng r e e ' Sc r ng ha ac e itc s e s iy e e , nhe e . n he i e i pa i ef r nce. ' he i Cor v Ge aPhar ,339 F. 1 p. . nev m. 3d 373,1 ( d.Ci.2003) Sl ge a,almiai ort 377 Fe r . tn nerl i tton he e ie i nton i i r nta i t publc domai i i i t na ur lr s ttowi fom t ntr nve i s nhe e nd n he i n f t s he t a e ul l ng r he eplcidico r oft prora t' l a 1 (ntr lquoai omit (mphassadde . x i t s lsu e he i r.' d. t 379 i ena ttons ted) e i d) M or ove ,t r ul lowi fom t c i i dicl ur mus i ra y ha n. Ast e r he es t l ng i he xplct s os e t nva ibl ppe he Fe al Cicui has sae llj hee y der r t ttd, tin rnc ma nOt be esa ihe by pr abiii or y t bls d ob ltes pos i lte . The me e fctt ata c ti t ng may r ul fom a gi n s tofcic tnc s i sbiiis r a h era n hi es t r ve e r umsa e s nots fcen.'I r Robe ton,l F.d 7 7 ( d.Ci.1 (ntr quottonsomitd) ufii t' n e rs 69 3 43, 45 Fe r 999) i enal ai te (mphass adde . Ca es de i wih i r ani pai l t wheher t pu pore e i d) s alng t nheent tci ton ook o t he r td i r pr ton oft cli d c pound -f t uly f l d' t prora te nhe ent oduci he a me om -aihf l olowe ' he i r xampl bei e ng r l d u o Glx ,I c v No o a m Lt. 8 0 1.Su p.8 1 8 6 ( D. C.1 9 ) atd 5 ei p n. a o n . . v ph r d, 3 7 p 7 . 7 E. N. 9 3 , fn , 3 e F. 1 43( Ci.1 .A p i a tc 3d 0 Fed. r 995) ror r xampl i entyantci esacai dc e nher l i pat l me ompoundonl y i t cl i ed c pound i ti r a y- pr f he a m om s ûnva i bl ' oduc d when one f l t e m pl / a 8 e olows he xa e. #. t 74. l t s c e,W a s c e t tl l ng Exampl 1 oft M e a pa en i ibl n hi as t on ont nds ha blowi e he ht t t nvara y r s t i For 1 bu opi hy obr i a t r or t t Cl i l of t 1 2 pa e i e uls n m pr on dr om de nd he ef e ha am he 99 t nt s i r nty a ii e n s nhe e l ntcpatd.I uppor oft sar t hi gume ,W aton r ison t S ide ' ni ofis nt s ele he t n d'opi on t bl s hetc che s expe t Dr Rob tAdlngt who s t i d bupr on hydr om i - t ynt i mit r, . er i on. yn hesze opi obr de he r s t of whi h w as For l us ng Exa pl 1 of t M e a pat nt Dr A dlngt n c ude e ul c m i m e he ht e . . i o oncl d t f l ng Exampl 1i ra y r ulsi l(r Ibupr on h obr i hat olowi e nva ibl es t n ' m ) opi ydr om de. I i undiputd,howev ,t tt e i i dicos e ofExa pl loft M e a paent ts s e er ha he xplct s l ur m e he ht t pr esonl bupr on hydç hlri ,notbupr onhy obr de. ( i Tr 1 :3 42:* oduc y opi oc o de opi dr omi Tral . 41 1 -1 6, 2315- 0-23 1 1 '639:3- 8;Pl Ex.96 a 24!73. I ed,Dr Adlngt ad te a til : 1 , 4:3- 6, 1 1 . t ) nde . i on mitd t ra t t W a s i t uc e hi t m odiy Exa pl 1 t pr ce bupr on hydr om i by usng ha t on ns r t d m o f m e o odu opi obr de i hydr omi a d i tad of hydr hlrc a d. obr c ci nse oc o i ci Tr 1 7- 1) Thus bec s Dr . 42: 1 . , au e . he ht t nt s Adlng o di n f l t e i t dicl u e of Exa pl 1 of t M e a pa e , hi i t n d ot olow he xplci s os r m e e rm e i smpl notpr tve oft is ofi r nta ii ton,a i clary does not xpe i nt s i y oba i he s ue nhe e ntc pa i st e l de monsr t t tFonn Ibu opi hydr om i i t bna u alr s ttoFi fom t e ii tae ha pr on obr de s he ' t r e ul l ng r he xplct dicl ur o t prora t' Sc r n CXrp,339 F. a 1 s os e f he i r. he i g - J. ' 3d t 379. Ac or ngl on t sba i al , c di y, hi s s one t Cou tfndst tt M e apaentdoe noti r nty a i pa eCl m 1oft 1 pa e . he r i ha he ht t s nhe e l ntci t ai he 992 t nt W at on a gu t t Cl m 1 i neve t e s i r l a i pa ed be aus a pe s of s r es ha ai s rhel s nhe enty ntci t c e r on or na y s l i t a twoul have known t tt hydr hl i acd us d i Exa pl 1oft di r kil n he r d ha he oc orc i e n m e he M eht pa e c d b r pl e by hydr om i a d t f m bupr on hydr om i Th a t nt oul e e ac d obr c ci o or opi obr de. e Cour a i fndst s lne ofr s ng unpe s asve a t l ofa i pa i i clart tt t gan i hi i ea oni r u i . s he aw ntci ton s e ha he c lngi pa t ma n r y upon t knowldge ofone s le i t ar t s y mi sng hale ng ry y ot el he e kild n he t o uppl s i elment fom t cai e s r he l med i nton.Se Slucl alRubbe ,749 F. at71 'El Lil 7 F. nve i e r ur r 2d 6, i ly, 05 Supp. a 99 2d t 2. B.O bvi ousnes s W a s al o c endst tCl i s 9 a 1 oft $ 23 pa e ,Cl m 2 oft $ 9 pa ent t on s ont ha a m nd 0 he 8 t nt ai he 01 t , a Cl m 3 oft e $ l pa e ar i 1d f obvi ne s3 A pa e ma notbeobt i d f ft nd ai h 6 0 t nt e nva i or ous s . t nt y ane k he i d fee c sb t e te s b e tmatrs u h t b p tn e a d t ep ira taes c ta t e ifr n e ewe n h u j c te o g t o c ae td n h ro r r u h h t h s j c matra a whol woul ha be o ousatt lme t i nton wasmade t a ube t te s e d ve en bvi he i he nve i o p s ha ngor nays li t a tt whih s ds j ctmaterpe ti . 35U. C.j 1 a) eron vi di r kiln he r o c ai ube t rans' ' S. 03( . S s ous s i a que ton of l ba e on unde l ng f t . Gr p One Lt v Halma k obvi nes s si aw s d ryi ac s' ' ou , d. . l r O bvi ne s i de er i d w ih r s tt ous s s t m ne t e pec o s e l . e te s be tmatra awh l,n tsp rt pe e oftecam. Sanqh-yntheabo v Apotx, h u j c te s oe o e a ae ic s h li l . 550 F. 1 nc, 3d 075,1 ( d. r 2008) 086 Fe Ci. . 3Thea s redcli oft e . a k 1 pae sr aet c bi ng bupr on hydr om i wih pha mac tca s e t ams h 823 nd 0 9 tnt elt o om ni opi obr de t r eu i l excpi st p o econr l rl s an oncea- y bupr onhydr omi f multons Cli 3 oft : 1 i ent o r duc toled eea e d - da opi obr de or a i . am he 6 0 pae r atst us oft s f tnt el e o e he e onnultonst tea depr son. a i o r t es i 1 Le St . gal andar d To es a i h a pr m a f c e c e of obvi nes ,t pa t c l ngi t pa en m us t bls i a i as ous s he r y hale ng he t t t pr ve by cea a c nci e de e t ta pe s ofor na y s l i t a twoul ha be n o l r nd onvi ng vi nc ha ron di r kil n he r d ve e motva e t combi t t c ngsoft pro ar r f r est a hive t c am e i nton, i td o ne he ea hi he i r t e e enc o c e he l i d nve i a t ts d a ts n woul ha ha ar s bl e nd ha ai ria d ve d ea ona e xpecaton ofs ce si doi s Pr t dr ti uc s n ng o. ocer Gambl Co.v Tev Phar US l ,566 F. 989,994 ( d.Ci.2009) Undepimi t s e . a m. A, nc. 3d Fe r . r l ng hi lga i r a ef gr psoff t fndi :()t s opea cone oft prora t( t e l nquiy r our ou acual i ngs a he c nd tnt he i r; b) he lv lo o d n r s ili tea t ( )t ed f e c sb t e t ecame s be tmatra d te e e f r i ay kl n h r; c h if n e ewe n h li d u j c te n h kr prorar;a ( s c i t nd d) e ondar c i ai (1non- ous s ,s h a c y onsdertons )- obvi ne s uc s ommer als c s ci uc es, ln -etb tu s le ne d ,a d fiu e o' t es4 Dyba l x i a b n Gmb lv C. Pa rc o g f l u n ov d e s n alr toh r. ' r k tl r e t f b . H. tik Ct. 46 F. 1 ?, 4 3d 356, 1 ( d.Ci.2006) Gr 360 Fe r . , aham v,John De r Co. 38 U . 1 1 1 e e , 3 S. , 7- 8 (966) (l a pae c le rma a prma fce s ng ofobvi nes,t owne ma 1 . Cf tnt halnge kes i a i howi ous s he r y r bu ba ed o t e t s n unexpe t d r s t 'by de onsr tng eha t cli e i c e e uls m ta i t t he am d nventon e bis s i xhi t ome s i pr ry or a nt t t a pcr on of or na y s l i t r e nt a t w oul ha uperor ope t dva age ha s di r kil n he el va r d ve f ound s ii orunexpe td.' Pr tr(rGambl C(,566 F.d a 994 ( i I r Soni uprsng ce '' oce : k e ? . 3 t quotng n e , 54F. 746,750( d. r 1 . 3d Fe Ci. 995) I KSR l 1Co.v Teqlx,/ . 550 U. 398,407( ) t Supr Cour rj ce a n nt . lfe nc. S. 2007, he eme t ee td rg d a ia i oft t c ng,s i i pplc ton he ea hi uggesi o m o i ton t s,and r a fnne t tt Gr ton, r tva i e t e f i d ha he aham f t sCc i t defne t i r t tc r s'a obvi ne sanays s Ne rhels ,t acor tontnue o i he nquiy ha ontol' n ous s l i . ve t e s he 4TheCour notst m a oftes fct ar notdiputd byt pa teshe e.Fori t ce t parisdo not t e hat ny h e a s e s e he ri r nsan , he te diput whehe an oft cie rf r nc consiutsp i a ta donotdiput t tal prorati t sca e s e t r y he t d e e e es tt e ror r nd s e ha l i r n hi s exitd a ofJ 27,2004(. t t ii dae. oroneye rbeor t pat applcai atis we e se s une ie.he k tcal t ' cr ' a f e he ent i tons s ue r s te .I a ton,t pa tes expe t ofers t i l smia defnii ofape s ofor nay s l i t ubmi d) n ddii he ri ' rs f ubsantaly i lr i tons l ron di r kil n he a t The eor ,t Cour fndst tape s ofor na ys l i t a haseihe agr duaedegr i r. r f e he t i ha ron di r kil n he n t r a t ee n pha ma tc s inceorar aeddici i wiha l tt oyeasofe re i pha c ialde opm e r ceuial ce elt s plne t t eas w r xpe ince n nna eutc vel nt orphysca che sr oraler tvel pos e s aba orsde e i on ( mor oft s mefel wiha l s i l mity, t na i y s s es chel ' gr e n e or e) he a i ds t t ea t fveye r ofe incei pha mac i de opm e orphyscalc i a s xpere n r eutcal vel nt i hemit'. sl y Cour ac w l d t i t kno edge he mpora e ofi ntf ng ' r a on t twoul ha pr tnc de iyi ' e s ha a d ve ompt a pe s n ed ro of or na y s l i t r e nt fed t c bi t eeme s i t way t cai di r kil n he elva il o om ne he l nt n he he l med new i nton doe . The ef e,ttr m ansnec s a y t i iy s nve i s' ' r or ii e i c s r o dentf ome r as t twoul ha l a e on ha d ve ed c m it t modiy a known c he s o f ompound i a pa tc ar m a r t esa ih prm a f ce n ri ul nne o t bls i ai da . he ndu . d. . pha m y. obvi ne sofa ne c am e c ous s w l i d ompound. Take (' m.l s,Lt v Al phar '/ ,492 ' ' ton, he t d ha nve i F. 1 0,1 7 ( d.Ci.2007) l addii t KSR Cour hel t t an i nton may be 3d 35 35 Fe r . n f ound obvi i i w oul ha be kobvi t t y. KSR,55 U . a 421 A pa e cl i i ous f t d ve en t ous o r ' ' 0 S. t . t nt a m s obvi t ty i Sher i a desgn nee orm a ke pr s ur t s ve a pr e a t r a e a ous o r f l e s t i d r t e s e o ol oblm nd he e r tnie numbe of i ntte pr dit bl s u i ' a pur ui o t e s u i d e ds t t i t r de ii d, e c a e ol tons' nd s t f hos ol tons t a o he l a i pae s ce s' I ntci td uc s . d ' Thus snc KuR' heFe r Cic tha e ,i e % t de al r ui s mphasz t ti edit biiy i t t hsone ied ha i c a lt s he ouc t pr ofobvius s . De y S ne l .p Me r c .tà ma Dane .l . 567 F. 1 4,1 o ne s' pu pi , nc , dtoni %l r ' t k nc, 3d 31 326 ( Ci.2009) ig-he' e ca er ul'dic s i KSR r esnotonl t t e ctton Fed. r . û-l pr ditbl es t s used n l efr y o he xpe ai t tprora tee e sar c bl ofbeng physca l c ha i r lm nt e apa e i i ly ombi d,buta s t tt combi ton ne lo ha he na i woul ha wor d f isi en dpur e. / (nena ctton omit . l t i tntc e, d ve ke or t nt de pos ' J. itr l iai ' ted) n he nsa as t i e d pur e of t cli d i tons was t c e t a bupr on f m ulton wih he ntnde pos he a me nven i o rae opi or a i t i ov d sabiiy ove t e pror ar bupr on hydr hl i f multons. The ef e, f mpr e t lt r h i t opi oc orde or a i r or or W a s t e t bls t tt as ere pa e c a m s a e obvi ,W a s m us pr by cl ara t on o s a i h ha he s t d t nt l i r ous t on t ove e nd con ncng e de e t t a or na iy s le arian i 2004 woul ha bee motva e t vi i vi nc ha n di rl kild ts n d ve n i td o combi t pror a tr f r e t ac eve t cli e i ne he i r e e enc s o hi he am d nventons i t s ca e a con r l i n hi s toled r l as or onc - da bupr on hy obr i f m ul ton and t s d a ts n woul ha ee e e a- y opi dr om de or a i hat ai r i a d ve ha a r as bl expe t ton t t a bupr on hy obr de f multon woul a hi t d e ona e c a i ha opi dr omi or a i d c eve he a tc pa e s ce s i t s c e g ea ers a lt ove bupr on hy oc or de f m ul tons n i i t d uc s n hi as r t t biiy r opi dr hl i or a i . J Was nha n te tbihe aprma cec s o bvo s s . to s o sa l d i fa i a e fo iu ne s s Ta ng i o a cou t Gr ki nt c nt he aham f t s t Cour fndst tW a s ha notm a t acor , he t i ha ton s de he r quied s e r howi Spe ii aly,W aton hasnotpr d by cea a c ncng e de e t ta ng. c tc l s ove l r nd onvi i vi nc ha pe s ofor nar s l i t a ti 2004 woul ha ha a r as bl expe t ton t tch ng r on di y kil n he r n d ve d e ona e c a i ha angi t s t i a bu opi f m ulton fom hydr hl i t hydr om i woul r s t i he al n pr on or a i r oc orde o obr de d e ul n i r s s a lt nc ea ed t biiy. As a g r r e,s t s e ton i a u e c a e a t Nume ous p i a tr e e es ene al ul al elc i s n npr dit bl r. r ror r ef r nc pr ce a ti s pp tt sprnci e. ( e Def Ex.1 a 20550 (i r e' ( lci as l odu d t ral u or hi i pl Se . 32 t $ g ' See tng at Be ) f m t e bist de ie c nai ofpr ri i a difcul smimpiia c c l or hat xhi t he srd ombi ton ope tes s fi t e e rc l hoie.; De.Ex.1 3 a 20737 (i d' (a l le-lx.1 at3683048(i ghl ' (ame) De.Ex. f 7 t iGou1 ' sme ; l l : 66 ) .' iBi ey' s ; f ) 3 a7 45 t 40703 (t vis' (bher i yet no r i e way ofprditng e ty wha e f t ûDa e ' tf e s . elabl ) e ci xacl t fec c ngi t s l f m ...wilha on isbi ogiala tviy ....) Def Ex.383 a 7931 ha ng he at or l ve t ol c ci t '; . ' t 4 (i r ck' (s orunael t r i no rla ewayofpr ci t i l nc ofapariulr û be ' C ve ) unf t t y, hee s eibl editng he ntue e tc a s ts cison t beh oroft pae compound.l Pl Ex.8 a 1C' ac ' (tT1 a lt al pe e he avi he rnt '; . ' 2 t Bl k') $ he biiy ( t pr c whi s l f ms wil hav dcsrbl pr ris i ese i l none se .'. o edit ch at or l e ia e opete s sntaly xitnt' ) l W a s has notcied t a wine s t tm ony or pr or a tt t c r c s t s g r t on t o ny t s cs i i r ha ontadi t hi ene al r e a whie W a s has ct d s r l pror a tr er nce t r f r t bupr on-elt ul, nd l ton ie eve a i r ef e s hat e e o opi r aed c ompounds none wih t e e e i ofBilnghurta e st is ofsabiiy. Thus W as , t h xc pton li s ddr s he s ue t lt , ton r i s on t t tm ony of is phar a utc e r -I r G r ha Buc on. A tti lD r Buc on ele he es i t m ce i s xpe t ) . a m kt r a . kt t s ii t tt pr ora ts e tfed ha he i r ugge t d m ovi t a bupr on hydr om i f m ul ton as a w a se ng o opi obr de or a i y t s ve t known s a lt pr em s w ih bupr on hydr om i f m ul tons D r Buck on o ol he t biiy obl t opi obr de or a i . . t cied s ve alprora tr f r nc i s t e r i r e e e es n uppor oft s c us on. t hi oncl i The fr t i a 1 6 publca i b Phii L.G oul tted,ksal Sel ton ofBa i D r ' i s s 98 i ton y lp d il û t ec i s c ugs' (û d' .( .Ex. :Gou1 ' Def ) Goul c ans a cha t wih t ee s d ont i r t hr ugge tons f i ovi t si or mpr ng he sabiiyofas l. ( .Ex.1 3 a 20747. Goul strts si i t r duc hygr c ct t lt at Def 7 t ) d' ss ugge ton s o e e os opiiy by i r sng t a d' hydr nc ea i he ci s ophobi t a usng a c r ciy nd i a boxylc acd i t d ofa s phoni o i i nsea ul c r mi al acd. ner i i u s t d, h s ndipu e owev , t hydr omi i a mi r l acd s t not a er hat obr de s ne a i al, caboxylc a i s t s t s t ac ng ma ha a t ly die t one a y fom t r i cd al, o hi e hi y ve cua l r ced wa r he hydr o de.( ilTr 442:8- 1 ) obrmi Tra , 1 443:0. Goul ss ond s d' ec ugge ton f i ovi sabiiy i t us a a d wih a hi he pKa t si or mpr ng t lt s o e n ci t g r o r du t a i t oft a qu e ce he cdiy he c eouss uton. l i undiputd,howe ,t thydr om i a d i ol i ts s e ver ha obr c ci s oneoft fw a dswihaI rpKat n hydr hl i a d ( woul t i e s a i t , he e ci t owe ha oc orc ci and d hus ncra e cdiy) s t sta hi may alo ha die e one awa fom t hydr omi ( .Ex.1 a o hi e c ng s ve rctd y r he obr de. Pl 03 t 1 349.TralTr 443: 6- 1 ) 03. , i . 1 444: 3. G oul s t r s d' hid ugges i i t r i e t m e tng poi of t s t A s one of t e ton s o a s he li nt he al. hr e pos i lte f doi s he s sbiiis or ng o uggcsschoosng a s lcount i lsi t chl i a t t i mal er on, itng he orde nd he br de a e mpl s l a 2003 ve son o1 t s me cha tr oduc d by P.Hei i Sthl omi s xa e . n ri - he a r epr e nrch a , howeve,t br dei i no l rrf e e asa exa eofa's l cou e i ' ( f r he omi on s onge ecrnc d n mpl lmal ntr on.' De . Ex.1 at205 ) AttilDr Buc oncoul ofkrnoe a ton f t s eque omison 30 98. ra . kt d t xplnai or he ubs nt si oft br de i fom t Goul c r,nordi heexpl n why hechos t r l o t out t he omi on r he d ha t d ai e o ey n he daed 1 6 ve s on of t Goul c r ,r t r t n t 2003 St ver i t t w a c e por ne 98 ri he d ha t a he ha he ahl s on ha s ont m a ous wiht tmeoft i nton.( i 'r 74:9- 1 ) t he i he nve i Trall . 1 76:7. l a ton,Goul s s gges i t r i e t m cli poi oft s twoul notl a t t n ddii d' u ton o a s he tng nt he al d e d o he s e ton ofa hyd obr i as a m e t i pr t s a lt of a hydr hl i s t be aus el c i r om de ans o m ove he t biiy oc or de al, c e t r a i m eli poi s of c o i s a br i a e notpos i e t pr di t Fo exa pl , he el tve tng nt hl r de nd om des r s bl o e c . r m e lt um br de a s u br i ha l rm etng poi s t n t i c orde c ai ng ihi omi nd odi m om de ve owe li nt ha her hl i ont ni co e pa t ; c unt r r s onve s y, a m oni br i ha a hi r m eli poi t n a m oni r el m um om de s ghe tng nt ha m um c orde M or ver bupr on hydr omi a ualy hasa l r metng poi t n bupr on hl i . eo , opi obr de ct l owe li nt ha opi hydr hl i e. ( .Ex. a 1 ) oc ord Pl 94 t 3. Thus none oft s , he ugge tons i Goul woul ha ld a or na iy s led a ts n i si n d d ve e n di rl kil ria n 2004 t r a ona y e o e s bl xpec t t s t ng fom a hydr orde t a hydr om i woul t ha wichi r ochl i o obr de d i ove s l sa lt l f t Goul s s esi may have a t l 1 one a y fom mpr at tbiiy. n ac, d' ugg tons c ualy ed wa r c hoosng ahydr om i t s vet known sabiiy pr em wih bupr on hydr hl i i obr de o ol he t lt obl t opi 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 ton by Lyl D . ia i e Bi ey tte l l For ofDr a Abs pton'(i ghl '. ( f Ex.1 ) Alhough ghl ild,i t ms sa ugs nd or i ' iBi ey' De . ) 66. t Bi e ta hest ts ts e ton i aditcul choie ( .Ex.1 a 3 048) Dr Buckon ghly e c ha al elci s fi t c Def 66 t 683 , . t ct d Bi e a ti a pu p tdl conti ng a r a on t s l tbupr on hydr omi t ie ghly t ral s r ore y a ni e s o eec opi obr de o i pr s a lt of bupr on hy oc orde f m ul tons ( ilTr 99: 25. I pariulr m ove t biiy opi dr hl i or a i . Tra . 3- ) n tc a , Dr Buc on poi ed t t f l n sa e e unde t h di Pr par ton ofOt rM i a . kt nt o he olowi g tt m nt r he ea ng e a i he ner l Acds: ûM i a a ds ot t n hydr chl i s h ass f i phos i , a hydr om i , i û ner l ci her ha o orc- uc ulurc, phorc nd obr c ha bee e pl d prnci ly t r ve n m oye i pa l o educ hygr c c t a pe haps t a diy of a r uli e os opi iy nd r he ci t es tng s ui ' ( f Ex,1 a 3683080. olton. De . ' 66 t ) Thi s c i how e r cont i no di c s on of s a lt Ra her s a lt i addr s ed s e ton, ve , a ns s us i t biiy. t , t biiy s es i t f l ng s ton,a whie t ts c i men i n he olowi eci nd l ha e ton tonss ve alpos i e optons t i ove e r sbl i o mpr sa lt usngahydr omi s l i notontottem.( .Ex.1 a 368 0. Furhemor tbiiy, i obr de at s 'h Def 66 t 308 ) t r e, gi t Bilng s ha ale dy t t a num b of bupr on m i r ac ds al t not t ven hat li hur t d r a esed er opi ne al i , bei he hydr om i , a f obr de nd ound al of t l hem t be unsa e Bi ey' s at m e abou r duc ng o t bl, ghl s t e nt t e i hygr copiiy by usng ot rm i r la dswoul pr de ltl gui e t an or na iy s le os c t i he ne a ci d ovi ite danc o di rl kild a ts n i 2004 l ng t s ve t know n s a lt pr e sw ih bupr on hydr hl i e. ri a n ooki o ol he t biiy obl m t opi oc or d M or r t r l i hygr c ct of c orde a br i i no pr c a e. I eove , he eatve os opi iy hl i s nd om des s t edit bl n s e ca es br i s a e m or hygr c c t n chl i ; i ot r c es chl i a e m or om s om de r e os opi ha ordes n he as ordes r e hygr c c t os opi han br i s a i s il o he c e , t y a e com pa a e. For e m pl om de ; nd n tl t r as s he r r bl xa e, p a sum br de i mor hygr c ct n pot s i chl i whie on t ot rha lt um ot s i omi s e os opi ha a sum orde, l he he nd ihi bomi i mor hygr c ct n lt um c orde.( .Ex.94a 1 ) And i t Ha di a r de s e os opi ha ihi hl i Def t 2. n he r ng nd Basi r ee scied by Dr Buckon (nd dicuse mor t oughl beow) hydr omi tn efrnce t . t a s s d e hor y l , obr des andhy ochl i aes dr ordes r hownt becompaabl no difrnt i tr ofhygr c ct ( il o r e, t tee ,n ems os opiiy. Tra Tr 78: 1 812l) . 2- : . Bi ey a s pr des a de s on t e t gui f m ul t s i s e tng a s t bl s t ghl l o ovi ci i r e o de or a or n el c i uia e al. ( f Ex.1 at3 07 ) Thede sonteei c tst ti c ca i t lt i e ount e De. 66 683 6. cii r ndiae ha f hemi l nsabiiy s nc erd i a m i r a d s l a ca egor t w hi h hydr hl i and hydr om i bel n ne al ci a t t y o c oc ordc obr de ong t pa h t he t o f l i t ma anor ni s t n t ty a he mi r acd s t ( .Ex.94at1 6.Tral olow s o ke ga c al, ot o r not r neal i al. Pl 5-1 , i Tr 446: 447: ) I fc,Bihly ta s t tmi a ci s ls pr . 23- 24. n a t g e e che ha nerla d at oduce a mor hosie e tl e r nta tnd t be ls sa e t n a s f t orc boxylt s l. ( f Ex.1 a nvionme nd e o e s tbl ha ulonae ar ae at De . 66 t 3683 062, 3683067. Thi i c itnt wih Goul s tac ng t t i t lt du t ) s s onsse t d' e hi ha nsabiiy e o hygr c ciy s dbea ese bytyi ac boxylcacd (nor ni a i . ( f Ex.1 os opi t houl ddr s d r ng ar i i a ga c cd) De . 73 a 20747. Thus nohi i Bi e s t ) , t ng n ghly uggess t t a hy obr de f multon woul be t ha dr omi or ai d r s bl e c e t i pr t s a lt ofa hy oc or d f m ul ton. ea ona y xpe t d o m ove he t biiy dr hl i e or a i Dr Buc on as cied t a 2000 publc i by Ri ha d J.Ba tn,bu t sprora tofer . kt lo t o iaton c r si t hi i r f s no gui nc on how t i pr da e o m ove t s abiiy of a hydr hl i s t l t a one bupr on he t lt oc or de al, e l opi hydr orde. ( .Ex.1 6. The lnalprora tr f r e cie by Dr Buc on ass si ochl i Def 7 ) i i r e e enc t d . kt ugge tng t ty bupr pi hydr om i t s ve t known sabiiy pr ems wih bupr pi o r o on obr de o ol he t lt obl t o on hydr hl i i U. Pa e No.6, 1 9 , tld Ma 1 l (he Sdar ng pae ' . ( . oc orde s S. t nt 1 0,40 ie y 7, 995 t t di tnt' Def l ) Ex.1 ) I hi e r rpor,Dr Bu on cie Hadi f is pur td tac ng t ta 38. n s xpe t e t . ckt td r ng or t pore e hi ha hydr omi s l ofa i e c obr de at n ndol ompound wa s a e whie t hydr hl i s l s s t bl l he oc orde at uppos dl e y wasnot ( .Ex.602 a 31. Atti ,howe r Dr Buckon wasf ce t c edet tt . Def t ) ral ve , . t or d o onc ha he Ha di patnt i f c t ughtt t i e hydr hl i s l was sabl . ( ilTr 78: r ng e n a t a hat he ndol oc orde at t e Tra . 21 8 8. l a ef tt e an t sa e i 2: ) n n for o xpli hi pparnt nconsse y.Dr Buckon a te t ti i not itnc . t dmitd ha t s pos i e t pr c t e sa lt of bupr on hydr om i ba e on i onnai abou t sbl o edit h t biiy opi obr de s d nf ton t he sa lt ofdif r tdr .( i Tr 8125- 22. t biiy fe en ugs Tral . : 82: ) Dr Buck on t c ime t t o c . t hus onfr d ha ne annot pr c ho t sabiiy of bupr on edit w he t lt opi f mul tonswilbe a f td by a c nge i s l ba ed on t a hi a or ai l fece ha n at s e c ngs boutt c r s he ore pondi ng s ls ofot rdr . Thata ison i c it n wih t m a pror a tr e e st tt ac at he ugs dm s i s onss e t t he ny i r ef r nce ha e h t t s t s l ton i i r nty unpr di a e and. i pa tc a ,wih t sa em e m a i t ha al e ec i s nhe e l e ct bl n ri ul r t he t t nt de n he Da esr er nc Slhe e i.asye ,no r i e way ofpr ditng e c l wha e f tcha ng vi ef e e: t- r s t elabl e c i xa ty t fec ngi t s tf m ofa a tve d g wilhave on is bi ogiala i t , and t s he al or n c i nl l t ol c ctviy he upposton t tt ii ha he s m es l f m oft r lt d par ntc a at or wo ea e e ompoundswilbeha i e c l t s m ewa m a notbe l ve n xa ty he a y y co r t' ( f Ex.345a 7 03. rec. De . ' t 407 ) W a s ha c t d t no ot pr or a tr c e s s t on s ie o her i r ef r nce ugges i t s t hi t s l f om tng hat wic ng he a t r hy ochl i t hydr omi woul r s ti a m or sa e bupr on f dr orde o obr de d e ul n e t bl opi onnul i . W a s aton t on a t m pt t ove com e t s i por a de i i y by a gui t tobvi nes c n be ba e on t te s o r hi m t nt f c enc r ng ha ous s a sd he av l lt ofhi t oughputs ee ng as a m ea t)r dl cr a e and t tm a s ls a once. aiabiiy gh-hr cr ni ns ( api y e t es ny a t t At ti , D r Buc on t s i i d t t gi t a l lt of t s hi t oughput s e ns i ral . kt e tfe ha ven he vaiabiiy he e gh hr cr e n - 20 a pe s oror na y s l i t a twoul ha i ude bupr on hy obr m i i a 04, ron di r kil n he r d ve ncl d opi dr o de n s r e f ale at s l t s ve t sa lt p oblm swih bupr on hydr hl i . ( i Tr c e n or tm e at o ol he t biiy r e t opi oc orde Tral . 89: 1 ) 6- 3. Hi t oughputs r ni howe , gh-hr c ee ng, ver doesnoti iy whi h s ls i a ar s t ef dentf c at , f ny, e uiabl or a pa tculrpu pos r her i smpl i ntfe whih s t ca be f ri a r e; at , t i y de ii s c als n onne . A ft scr ng,one d er eeni woul sil ha t r nume ous t t on t r uli s t t deer ne t r i vi l d tl ve o un r ess he es tng als o t mi hei ndi dua pope tes ( ilTr 409: 841 5,Def Ex.602 at1 .M a De 1 23- 711 ) As Dr r ri . Tra . 1 - 0:. . 5, es p. 70: 1 :3 . . And s ts ii d,e n i one us d hi t oughputs r e ng, whi h Valantdi notus i is eron e tfe ve f e gh-hr c e ni c e d en t de l pm e ofbu opi hydr r de, one woul sm pl be l twih t bunc ofs ls . . . . ve o nt pr on ob omi d i y ef t $ a h at You t ha t s udy t m sa t r s a l of wor t r .' ( i Tr 409:8- l 5. So hen ve o t he nd he e' ot k he e ' Tral . 1 4 0: ) whie hi t oughputs e ni woul ha alowe one t cr a eand t s m a s lsa onc , i l gh-hr cr e ng d ve l d o et e t ny at t e t woul notha a l d one t r a ona y pr c t i vi lpr ri oft r uli s t d ve lowe o e s bl edit he ndi dua ope tes he es tng als i a nc n dva e. l i f t sra on t tt Fe r Cicui hasrjctd t agume t obvi ne s t s or hi e s ha he deal r t ee e he r nt hat ous s c n beba e on t a lbiiy ofa t -he f c t tng. S eS n h,5 0F.da 1 8 (ee tn a sd he vaia lt fert - a t esi e a o 5 3 t 0 7 rj cig ar m e t ta cai d c pound m a be f gu nt ha l me om y ound obvi i one s le i t a tc d ha ous f kild n he r oul ve pr e t cai d compound and t n done r i t tng t as es whe he i ha t oduc d he l me he outne esi o s s t r t d he de ie pr ri s and i t a r quii t t obvi ne s be as e s d ba e on wha was sr d ope te nse d e rng ha ous s sse sd t pr ced a edit bout t pr tes i adva c of t s i he operi n nc e tng) l d, because pr dit lt i t ndee e cabiiy s he . t hsone ofobvi ne s t obvi nes a yssmus f uson whe he bas d on t pror ouc t ous s , he ous s nal i t oc t r e he i a t t f vor bl pr tesoft c am e i nton c d be r s bl pr c e i a nce r- he a a e operi he l i d nve i oul ea ona y edit d n dva of a t s i ny e tng. Se i The ef r , t a ia lt of hi t r e d r o e he va l biiy gh- h oughput s r e ng i s m pl not c e ni s i y pr tve oft i s ofobvi nes . oba i he s ue ous s l i f t e s me r as t tW a s s a gumen bas on t ale d populrt of t s or hes a e ons ha ton' r t ed he l ge a iy hy o om i s i 200 mus alo f i. A s tm a bepopulrf ma r s dr br de n 4 t s al al y a or ny ea ons s t f c t t , o he a t ha hydr om i may ha be n t t r mos c obr de ve e he hid t ommonl us d s l i 2004 wihou e ani y e at n t t xpli ng - w/ i wa s pr va e - i smpl not pr tve a t whe he a bupr on hydr br i l t s o e l nt s i y y obai s o t r opi o om de f m ul ton w oul ha be r as abl cxpe t d t i pr e t e s abiiy of bu opi or a i d ve en e on y c e o m ov h t lt pr on hydr hl i f multons oc orde or ai . Ac di y, t Cour fnds t t W a s has not pr d by clar and c nci cor ngl he t i ha t on ove e onvi ng e de e t ta or na iy s le aria i 2004 woul ha r a ona y e vi nc ha n di rl kild ts n n d ve e s bl xpeced a bu t p r on opi hydr omi f m ulton t have i ove sa lt over t bupr on hydr hl i obr de or a i o mpr d t biiy he opi oc orde f m ul tons Thus W a s hasnotes a ihed a prm a f ci c s ofobvi ness. or a i . , t on t bls i a e ae ous J Se o a yc nsd r to ss p r a ig o n o vou n s . c nd r o ie a in u po t fndn fno - b i s e s Eve as umi ar ndo, t tW a s ha e t bls d aprma f i ca e ofobvi nes n s ng, gue ha t on s sa ihe i ac e s ous s , t Cour fnds t tVa e nthas i r e s fcintevi e of une he ti ha l a ntoduc d ufi e denc xpece r uls t r but td es t o e s has uc howi The e de a ng. vi nce dduce a ti de onsr t t tValants cli e i tons d t ral m taed ha e ' a m d nven i hav sgnii a u e i fc nt nexpe e a nt ges ove t bupr on hydr hl i f m ultons ctd dva a r hc opi oc orde or a i , i u ngal ncldi onger( doubld)s flf, r ed rsk ofs zur , t abiiy t f mul t a si e e hel ie educ i ei es he lt o or ae ngl tblt a al dos ge srngt (ncl ng t hi s dos ge) i pr d r it nce t dose a e t l a te hs i udi he ghe t a , m ove essa o dumpi a e irma a t a lt due t r duce c r i t . ng, nd ase nuf c ur biiy o e d or osviy ( i Tr 31 1 322:3. Tral . 0:6- 1 ) W a s n a g t tVaea ha f ie t de onsr t t r quie nexus be w e n t s t o r ues ha l nt s a ld o m tae he e r d t e he e une c e r s t a t as e td pa e cli . The Cour fndst sar xpe t d e uls nd he s re t nt a ms t i hi gumentt be wihout o t mert A ne doe n r r t ta cli e es l r cie t a nt s of t pa ent d i. xus s ot equie ha a m xpr sy e t he dva age he t e i nton;i i enou t tt y fow die ty fom t i enton. Se Pr mpton D e c s nve i t s gh ha he l r c l i he nv i e ee i vi e , l nc. v M i s a M i ng & M .f Co.732F. 903, ( d. r . nne ot ni g. , 2d 907 Fe Ci. 1 8 )(ig l lspthf au e . . 9 4 s s ae ic e tr s . ç ! ' q . q ( ( do notpr ry bel i cli , t s e f ton ofwhih i t poi outditnc l ope l ong n a ms he ol unc i c s o nt si ty . . . r gh l te ) 3 ) ' . c omposton ofmat rwhih i pa e e , notisadva age . l i e iey pr , ne t l s i ii te c s t ntd t nt s t s ntr l oper verhees , n e ua i non- ous s ,f a c tt t i o a counta nt stowi die ty fom t val tng obvi ne s or our o ake nt c dva age l ng r c l r he i nton pae ed.)(ntr lquoai omitd) ll r t unexpect d r suls aow die ty nve i tnt ,, i e na ttons te .e e, he rcj e e t 4 t . ( , hydr om i a pha ma utc e i e s t pr obr de nd r ce i al xc pint o ovi c r ld r e e a onc ada de ontole elas nd e-- y l ) f m ultons of bupr pi hydr om i or a i o on obr de Thus t r i a nexus be we t une , he c s t en he xpeced t l l l . l a nt ge a t e a s t p en cai s dva a s nd h s ered at t l m ( . ) I addii ot s onda y c i r i s n ton, her ec r onsde atons uppor a fndi ofnon- ous s l t i ng obvi ne s n . pa tc a,t rpeae fiur ofot r durng t t nt year f l ng Bilnghur tt sol riulr he e td a l e he s i he we y s olowi li s o ve ) ) j ) l t known sa lt pr e swih bupr pi h oc orde s he t biiy oblm t o on ydr hl i uggesst tt cai i nt t ha he l med nve i ons j l t l wo l n th v b e o v o s See Advanced D ipl ysuyA., l .v.KentSt e Uni ,212 F 3d ud o a e e n b i u s a v ' nc at v. t ) . . 1 , 1 ( d. r 2000) Mi . ni & Mt (( v Johns & Johns Orho c 272 285 Fe Ci. . , nn.vi ng k. .. , ' ) on on t pedis , l l . nc, ! ) j ' j 9 6 F2 a 1 7 - 5 (e s nig t a c mp tt r- f l e t devel t pat ed i nton 7 .d t 5 4 7 ra o n h t o eio s aiur o op he ent nve i s se non obvius s. Furhemor, t fct t t t e ot c uggetd o nes) t r e he a ha hre her ompa es icu n ni , n ldig f j ' Wao,ae oi Alz dsi t aaaiyobp p nhd cli spos tnhv cpd pni e t h vibi fur i yrh reupr a s e e n pe e l l t o o o od t l , ) fn igofn n o vo s e s S eS ca t (o stsv CabotCor ,845 F. 981, 991( d. i dn o - b iu n s . e pe il ,mpo i y e p. 2d Fe j i j - . , ) I Ci.1 8)(i r 98 t copyi t cl me i nton r t t onei t publcdomai , i i catveof ng he ai d nve i aher han n he i n s ndi i f unobvi nes.'. ous s' ) l # ) . 4 TePiecsidsig i al *h f raes i nus be z t h t . k . At t ce er of W aton' obvi nes c le e i is ar he nt s s ous s ha lng s t gume t t t s c s i nt ha hi a e s 1 l ? c r ldbyP e , I v.Apot x, l . 48 1. 1 ( Ci.2007) Thepae exa ne ontole hz r nc. e nc, 0 $3d 348 Fed. r ' . tnt mi r l r ) wa madeexprs l awar oft P z rc edurngpr ec i oft pae si s t how ever s e sy e he jle as i os uton he tnt n ui, , ( ' r 1 ) ) i . - 21- t j é t f a concude t tt f t ofPfz rweeveydifrntfom t f t i t sca ea t r oe nd l d ha he ac s îe r r fee r he acs n hi s nd heefr . ir e ntt t pr e pr e ngs ( . 80at r el va o he es nt oc edi . Def Ex. 00078 ) Th Cour a e . 3. e t gres I P e tea s re p tn camsa1rltdt a o o ieb s lt, whi wascr td n fz r h s etd ae t li l eae o mld pn e yae ch eae t s ve t known sabiiy pr e swih aml o ol he t lt oblm t odopi m aeae. 1 a 1 54 ne l t d. t 353- . The Fede a rl Cic tf r ui ound t e c am st be o ous i viw oft h li o bvi n e h e k ri a i e f c s'oft ca e l a t tculrz d a t ' he s . d t pa l 68. Sale l , i C#ze te c tf nd t tnumeous pror a tt c ngs s cii 367i nty n r h our ou ha r i r ea hi pe fcaly l i c t d t ts t hi t t bes ae s twoul ndia e ha wic ng o he yl t al d r ul i i ove sa lt ove t m aeae es t n mpr d t biiy r he l t s t I a 1 62- 4. Her , how e r a dic s d a al. d. t 3 6 e ve , s s us e bove W a s has ofe e no smia ton frd i lr , t c ngs s ea hi uggesi t ts t hi fom t hydr orde s tt t hydr om i s l woul tng ha wic ng r he ochl i al o he obr de at d r ul i a mor sa ebupr on f mul ton. '' ,f t sa s ver ot rr as t Cou t es t n e t bl opi or ai lhus or hi nd e al he e ons he r ne d notdi c s ##z i ditnguiha ea doesn c r hee e s us , cr s si s bl nd ot ontol r . . Ac di y,r vi wi t e de e a eor ngl e c ng he vi nc dduce a tili lg oft Gr d t ra n i ht he aham fct s a or , t he Cour concude t W as hasnote t ihe b t l s hat ton sabls d y cl ra c nci evi nc t tVala ' ea nd onvi ng de e ha e nts cai d a s re pa e cai sa ei i f obvi l me s e td t nt l m r nvald or ousness. 1 1 C O N CL USI N 1. O Fort r s dic s a he ea ons s us ed bove t Cou tfndst W a s ha f l t pr by cla r s hat ton s aied o ove er . he a c ncng evi nce t t Valants a s red pa e cl m s a e i i . Acc di y,t nd onvi i de ha e ' set t nt ai r nvald or ngl he Co r wile trj d me t i fv r o Vae n a a an t W as n o Vae n ' cams o u t l n e u g n n a o f la t nd g i s to n la ts li f i rnge nt nfi me . D ON E A ND O RD ERED i Cha be s a M i m i Fl i t s n m r t a . orda, hi da ofNov y embe , 2011. r . * .. 1t i 4t f D' ' Cil'' 4 Copi pr de t es ovi d o: Cou elofRec d ns or . o No I TED STATES DI STRI J CT UDGE
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