9
D e = DG V@I YGDVIF SVMVIS FDSVZDCV CNYZV ONZ V@I FDSVZDCV NO FIEMXMZI SYGN_DNG \@MZBMCIYVDCMES DGC'% \emdgvdoo% v' FIT \@MZBM'% E'\'% FIT% DGC'% BTEMG DGC'% mgf BTEMG \@MZBMCIYVDCMES DGC'% Fioigfmgvs' ; Cdde Mcvdng Gn' <?"==3"E\S V`nbms @' Jica% Is}ydzi mgf Gime A' Fm`dtm% Is}ydzi no SDFEIT MYSVDG EE\% Gi x Tnza% GT' \mye K' [ihhiz% Is}ydzi no SDFEIT MYSVDG EE\% Xms`dghvng% FC' Kmca J' Jeybigoief% Is}ydzi mgf Amzig Kmcnjs Enyfig% Is}ydzi n o BNZZDS% GDC@NES% MZS@V / VYGGIEE EE\% Xdebdghvng% FI' Mvvnzgits onz \emdgvdoo' Ifhmz @' @myh% Is}ydzi mgf Smb _' Fismd% Is}ydzi n o OZNBBIZ EMXZIGCI / @MYH EE\% Gix Tnza% GT' Ied{mjiv` M' Eioo% Is}ydzi no OZNBBIZ EMXZIGCI / @MYH EE\% Xms`dghvng% FC' Zdc`mzf E' @nzxdv{% Is}ydzi mgf Fm df I' Bnnzi% Is}ydzi no \NVVIZ MGFIZSNG / CNZZNNG EE\% Xdebdghvng% FI' Mvvnzgits onz Fioigfmgvs' Kmgymzt =0% :<=: Xdebdghvn g% Fiemxmzi' BIBNZMGFYB N\DGDNG

Sunovion Pharmaceuticals, Inc. v. Dey Pharma., L.P., et al., C.A. No. 06-113-LPS

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Page 1: Sunovion Pharmaceuticals, Inc. v. Dey Pharma., L.P., et al., C.A. No. 06-113-LPS

8/3/2019 Sunovion Pharmaceuticals, Inc. v. Dey Pharma., L.P., et al., C.A. No. 06-113-LPS

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DG V@I YGDVIF SVMVIS FDSVZDCV CNYZV

ONZ V@I FDSVZDCV NO FIEMXMZI

SYGN_DNG \@MZBMCIYVDCMES DGC'%

\emdgvdoo%

v'

FIT \@MZBM'% E'\'% FIT% DGC'%

BTEMG DGC'% mgf BTEMG

\@MZBMCIYVDCMES DGC'%

Fioigfmgvs'

; Cdde Mcvdng Gn' <?"==3"E\S

V`nbms @' Jica% Is}ydzi mgf Gime A' Fm`dtm% Is}ydzi no SDFEIT MYSVDG EE\% Gix Tnza%

GT' \mye K' [ihhiz% Is}ydzi no SDFEIT MYSVDG EE\% Xms`dghvng% FC'

Kmca J' Jeybigoief% Is}ydzi mgf Amzig Kmcnjs Enyfig% Is}ydzi noBNZZDS% GDC@NES%

MZS@V / VYGGIEE EE\% Xdebdghvng% FI'

Mvvnzgits onz \emdgvdoo'

Ifhmz @' @myh% Is}ydzi mgf Smb _' Fismd% Is}ydzi noOZNBBIZ EMXZIGCI / @MYH

EE\% Gix Tnza% GT' Ied{mjiv` M' Eioo% Is}ydzi noOZNBBIZ EMXZIGCI / @MYH EE\%

Xms`dghvng% FC'

Zdc`mzf E' @nzxdv{% Is}ydzi mgf Fmdf I' Bnnzi% Is}ydzi no \NVVIZ MGFIZSNG /

CNZZNNG EE\% Xdebdghvng% FI'

Mvvnzgits onz Fioigfmgvs'

Kmgymzt =0% :<=:

Xdebdghvng% Fiemxmzi'

BIBNZMGFYB N\DGDNG

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v w > % $ v 1 SVMZA% Y'S' Fdsvzdcv Kyfhi;

D' DGVZNFYCVDNG

\zisigvet jionzi v`i Cnyzv ds v`i dssyi no dgcnz|nzmvdng jt zioizigci% x`dc` v`i |mzvdis

`mi zmdsif dg cnggicvdng xdv` Fioigfmgvs( moodzbmvdi fioigsi mgf cnygvizcemdb meeihdgh v`mv

v`i |mvigvs"dg"sydv mzi dgmedf onz mgvdcd|mvdng' Onz v`i zimsngs siv onzv` jienx% v`i Cnyzv mhziis

xdv` Fioigfmgvs v`mv v`i `nsv fncybigv% Jzdvds` |mvigv HJ = :40 646% dgcnz|nzmvis jt zioizigci

v`i |zmcvdcme yvdedvt no v`i cnb|nygfs fisczdjif dg v`i s|icdodcmvdng noJzdvds` |mvigv HJ = :<<

00?' Mccnzfdghet% v`mv bmvizdme xdee ji cngsdfizif vnhiv`iz ms m sdghei zioizigci onz |yz|nsis no

mgvdcd|mvdng mv vzdme% x`dc` ds sc`ifyeif vn jihdg ng Kmgymzt 3<% :<=:'

DD' JMCAHZNYGF

V`i |zisigv edvdhmvdng ds m @mvc`"Xmpbmg |mvigv dgozdghibigv sydv jznyh`v jt \emdgvdoo

Sygndng \`mzbmciyvdcmes Dgc' *Sygndng*$ dg zis|ngsi vn Fioigfmgvs( m||edcmvdng onz OFM

m||znme vn bmzaiv higizdc eimejyvizne' Fioigfmgvs cngvigf v`mv v`i |mvigvs"dg"sydv mzi dgmedf

onz mgvdcd|mvdng dg dix no m Jzdvds` |mvigv% HJ = :40 646 *v`i HJ (646 |mvigv*$% x`dc` v`it

cngvigf dgcnz|nzmvis jt zioizigci mffdvdngme bmvizdme si|mzmviet fisczdjif dg mgnv`iz Jzdvds`

|mvigv% HJ = :<< 00? *v`i HJ (00? |mvigv*$' Dg :<<4% v`i |mzvdis odeif cznss"bnvdngs onz

sybbmzt kyfhbigv ng v`i dssyi no mgvdcd|mvdng' Kyfhi Omzgmg% v`ig |zisdfdgh niz v`i cmsi%

dssyif mg n|dgdng mgf nzfiz figtdgh Sygndng(s bnvdng mgf hzmgvdgh dg |mzv mgf figtdgh dg |mzv

Fit(s bnvdng' F'D' 34:1 F'D' 343$ Kyfhi Omzgmg *zisiziQfR ficdsdng ng v`i dssyi nox`iv`iz

mgf vn x`mv ipvigv HJ (646 dgcnz|nzmvis jt zioizigciQR HJ (00?'* F'D' 34: mv =9 g'3$ V`i

|mzvdis syjsi}yigvet zi"jzdioif v`i dssyi no dgcnz|nzmvdng jt zioizigci |yzsymgv vn v`ds Cnyzv(s

Gnibjiz :3% :<== Nzfiz' F'D' 6891 F'D' 6881 F'D' 6081 F'D' 604$

=

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fivizbdgmvdng db|edcmvis dgcnz|nzmvdng jt zioizigci% v`i cnyzv(s znei ds vn fivizbdgi x`mv

bmvizdme dg mffdvdng vn v`i `nsv fncybigv cngsvdvyvis v`i sdghei zioizigci' V`i omcvodgfiz( s znei%

dg vyb% ds vn fivizbdgi x`iv`iz v`mv sdghei zioizigci fisczdjis v`i cemdbif dgigvdng' Sii df'

D_' FDSCYSSDNG

Ms gnvif% v`i |mzvdis ( fds|yvi cngcizgs x`iv`iz v`i HJ (646 |mvigv mfi}ymviet

dgcnz|nzmvis jt zioizigci v`i |zmcvdcme yvdedvt no v`i zmcibdc cnb|nygfs si|mzmviet fisczdjif dg

v`i HJ (00? |mvigv% syc` v`mv v`i |izvdgigv bmvizdme oznb jnv` |mvigvs |zn|izet cmg ji cngsdfizif

vnhiv`iz ms m *sdghei zioizigci* onz mgvdcd|mvdng' Fit cngcifis v`mv dvs snei mgvdcd|mvdng fioigsi

ds dmjei nget do v`i Cnyzv odgfs dg dvs omnz ng v`i dssyi no dgcnz|nzmvdng jt zioizigci' F'D' 683

mv ?9;=4":9$

Ms zi|znfycif jienx% v`i HJ (646 |mvigv svmvis dg zieimgv |mzv;

V`ds dgigvdng ds cngcizgif xdv` m |znciss onz v`i |zi|mzmvdng no n|vdcme

igmgvdnbizs no cizvmdg ="|`igte":"mbdgniv`mgne fizdmvdis x`dc` mzi fisczdjif dg

|mzvdcyemz dg nyz Ygdvif Adghfnb S|icdodcmvdng Gn' = :<<%00?'

Dg nyz smdf Ygdvif Adghfnb S|icdodcmvdng Gn' =%:<<%00? v`izi mzi fisczdjif

|`igtembdgniv`mgne fizdmvdis x`dc` bmt svdbyemvi \"mfzigizhdc zici|vnzs '''V`i |zmcvdcme yvdedvt nosyc` mcvddvt ds bnzi oyeet fisczdjif dg smdf s|icdodcmvdng'

V`i |`igtembdgniv`mgne fizdmvdis D$ bmt ipdsv dg vxn n|vdcmeet dsnbizdc

onzbs mgf mccnzfdgh vn v`i dgigvdng xi `mi fdscnizif m gix |znciss onz v`i

|zi|mzmvdng no syc` dsnbizs1 v`i mfmgvmhi no v`ds |znciss ds v`mv dv omcdedvmvis v`i

|znfycvdng no |yzi dsnbizs' V`ds ds no |mzvdcyemz db|nzvmgci dg v`ds cmsi sdgci v`i

|`mzbmcnenhdcme mcvddvt nongi dsnbiz dg svmgfmzf visvs onz jzngc`nfdemvnz mcvdng ds

izt byc` hzimviz v`mg v`mv no v`i nv`iz'

HJ (646 |mvigv mv =;4"36$ ib|`msds mffif$'

Sygndng cngvigfs v`mv v`ds |mssmhi fnis gnv smvdsot v`i eihme svmgfmzf onz dgcnz|nzmvdng

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zioizs vn v`i HJ (00? |mvigv ms jmcahznygf% mgf *gnv ms |mzv no v`i syjsvmgvdi fisczd|vdng no v`i

3

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dgigvdng'* F'D' 688 mv 3$ Sygndng oyzv`iz cngvigfs v`mv v`i HJ (646 |mvigv omdes vn dfigvdot

*xdv` fivmdeif |mzvdcyemzdvt x`mv s|icdodc bmvizdme dv dgcnz|nzmvis* mgf edaixdsi fnis gnv *ceimzet

dgfdcmvi x`izi v`mv bmvizdme ds onygf* dg v`i HJ (00? |mvigv' (Df mv 9$

Fioigfmgvs zis|ngf v`mv v`i HJ (646 |mvigv smvdsodis v`i zi}ydzibigvs onz dgcnz|nzmvdng

jt zioizigci jicmysi dv mfi}ymviet fisczdjis xdv` fivmdeif |mzvdcyemzdvt v`i s|icdodc bmvizdme

dgcnz|nzmvif d'i'% v`i |zmcvdcme yvdedvt no v`i zmcibdc cnb|nygfs( |`mzbmcnenhdcme mcvddvt$ mgf

mesn ceimzet dgfdcmvis x`izi v`mv bmvizdme ds onygf dg v`i s|icdodcmvdng no v`i HJ (00? |mvigv$'

F'D' 689 mv 6$

Mev`nyh` m censi }yisvdng% ng jmemgci v`i Cnyzv mhziis xdv` Fioigfmgvs v`mv v`i HJ (646

|mvigv mfi}ymviet dgcnz|nzmvis jt zioizigci v`i |zmcvdcme yvdedvt no v`i cnb|nygfs fisczdjif dg

v`i HJ (00? |mvigv' V`i Oifizme Cdzcydv `ms ̀ ief v`mv mgmenhnys svmvibigvs cngvmdgdgh sdbdemz

eiies no fivmde xizi syoodcdigvet s|icdodc onz dgcnz|nzmvdng jt zioizigci' Sii Cmeemxmt HneoCn'

v' Mcys`giv Cn'% 98? O'3f =33=% =369"68 Oif' Cdz' :<<4$ *Zioizigci ds bmfi vn ' ' ' Y'S' \mv'

Gn' 6%:86%?38 x`dc` fisczdjis m gybjiz noonmbmjei cnb|nsdvdngs no m c`mzmcviz x`dc` bmt ji

ib|entif ' ' ' onz v`i hneojmees no v`ds dgigvdng'*$1 Dg zi _nss% 998 O':f 0=:% 0=?"=8 CC\M

=488$ *Zioizigci ds bmfi vn Ygdvif Svmvis \mvigv Gn' :%4:<%48= ' ' ' onz m higizme fdscyssdng no

hemss"cizmbdc bmvizdmes mgf v`idz |znfycvdng'*$1 Dg zi @yh`is% 99< O':f =:83% =:89"8? CC\M

=488$ *Zioizigci ds bmfi vn m||edcmvdng Siz' Gn' =3=%=<0 onz cnb|eivi fisczd|vdngs nobiv`nfs

no |zi|mzdgh m}yinys |netbizdc fds|izsdngs m||edcmjei dg v`i `izidgmoviz fisczdjif dgigvdng'*$1

co Cnbbngximev` Scd' / Dgfys' Zisimzc` Nzh' v' Jyoomen Vic`' (YSM$% Dgc'% 96: O'3f =3?3%

=38: Oif' Cdz' :<<0$ odgfdgh gn dgcnz|nzmvdng jt zioizigci x`izi `nsv fncybigv biziet cdvif

6

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mgnv`iz fncybigv dg onnvgnvi xdv`nyv mgt oyzv`iz ip|emgmvdng nz fdscyssdng$': Dg dix no v`ds

|zicifigv% v̀ i Cnyzv odgfs v`mv v`i HJ (646 |mvigv mfi}ymviet zioizigcis v`i HJ (00? |mvigv xdv`

syoodcdigvet *fivmdeif |mzvdcyemzdvt* zihmzfdgh v`i |zmcvdcme yvdedvt no v`i cnb|nygfs fdscensif dg

v`i HJ (00? |mvigv'

V`i Cnyzv fdsmhziis xdv` Sygndng(s mssizvdng v`mv v`i HJ (646 |mvigv zioizs vn v`i

cnb|nygfs( |zmcvdcme yvdedvt biziet ms *jmcahznygf* mgf *gnv ms |mzv no v`i syjsvmgvdi

fisczd|vdng no v`i dgigvdng'* F'D' 688 mv 3$ Vn v`i cngvzmzt% v`i HJ (646 |mvigv bmais ceimz

v`mv v`i |zmcvdcme yvdedvt no v`i cnb|nygfs fisczdjif dg v`i HJ (00? |mvigv ds mg dgvihzme ms|icv

no v`i dgigvdng cemdbif dg v`i HJ (646 |mvigv' S|icdodcmeet% v`i HJ (646 |mvigv gnvis v`mv v`i

zmcibdc cnb|nygfs no v`i HJ (00? |mvigv *svdbyemvi w " m f z i g i z h d c zici|vnzs* mgf v`mv *v`i

|zmcvdcme yvdedvt no syc` mcvddvt ds bnzi oyeet fisczdjif* dg v`i s|icdodcmvdng no v`i HJ (00?

|mvigv' HJ (646 |mvigv mv =; =0"::$ Dbbifdmviet v`izimoviz% dg v`i gipv |mzmhzm|`% v`i dgigvnz

ib|`msd{if v`mv v`i dgigvdng dgneif v`i fdscnizt no m gix |znciss onz |zi|mzdgh v`i

dgfddfyme dsnbizs no mejyvizne% mgf v`mv *v`i mfmgvmhi no v`ds |znciss ' ' ' ds no|mzvdcyemz

db|nzvmgci ' ' ' sdgci v`i |`mzbmcnenhdcme mcvddvt no ngi dsnbiz dg svmgfmzf visvs onz

jzngc`nfdemvnz mcvdng ds izt byc` hzimviz v`mg v`mv no v`i nv`iz'* (Df mv = :9"36$ V`i dgigvnz

v`ys ceimzet dgfdcmvif v`mv v`i cemdbif |znciss onz |zi|mzdgh dsnbizs xms mfmgvmhinys mgf

db|nzvmgv |zicdsiet jicmysi v`i |`mzbmcnenhdcme mcvddvt " mgf% dg vyzg% v`i |zmcvdcme yvdedvt "

v`mv ds bnzi oyeet fisczdjif dg v`i HJ (00? |mvigv xms *izt byc` hzimviz* onz ngi dsnbiz

:Mev`nyh` v`i HJ (646 |mvigv fnis gnv s|icdodcmeet ysi v`i |`zmsi *dgcnz|nzmvi jt zioizigci%* v`i

cmsis cdvif mjni deeysvzmvi v`mv v`nsi s|icdodc xnzfs mzi gnv zi}ydzif' Bnziniz% v`i Oifizme

Cdzcydv `ms dgfdcmvif v`mv *gn |mzvdcyemz (bmhdc xnzfs( mzi zi}ydzif vn dgcnz|nzmvi m fncybigv jt

zioizigci'* Gnzv`zn| Hzybbmg% 939 O'3f mv =36?' Dgsvimf% x`mv ds zi}ydzif ds v`mv v`i m||edcmgv

*cdvQiR syc` bmvizdme dg m bmggiz v`mv bmais ceimz v`mv v`i bmvizdme ds iooicvdiet |mzv no v`i `nsv

fncybigv ms do dv xizi ip|edcdvet cngvmdgif v`izidg'* Mfmgcif Fds|emt% :=: O'3f mv =:0:'

9

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fivizbdgmvdng onz v`i omcvodgfiz vn zisnei mv vzdme' 6

_' CNGCEYSDNG

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zioizigci v`i |zmcvdcme yvdedvt no v`i cnb|nygfs fisczdjif dg v`i s|icdodcmvdng no v`i HJ (00?

|mvigv% mgf v`mv syc` bmvizdme xdee ji cngsdfizif ms m sdghei zioizigci onz |yz|nsis no

mgvdcd|mvdng mv vzdme' Mg m||zn|zdmvi Nzfiz oneenxs'

6V`i |mzvdis `mi mesn cdvif vn visvdbngt |zndfif jt mg dgigvnz mgf mg myv`nz no v`i

dgcnz|nzmvdgh `nsv zioizigci' V`i syjkicvdi dixs no v`isi dgfddfymes mzi gnv `ie|oye dg

zisnedgh v`i fds|yvi |zisigvet jionzi v`i Cnyzv% sdgci dv ds v`i njkicvdi svmgfmzf no *ngi

zimsngmjet sadeeif dg v`i mzv Qv`mvR s`nyef ji ysif vn fivizbdgi x`iv`iz v`i `nsv fncybigv

fisczdjis v`i bmvizdme vn ji dgcnz|nzmvif jt zioizigci'* Mfvmgcif Fds|emt% :=: O'3f mv =:03'

Sdbdemzet% v`i ip|izv visvdbngt cdvif jt Sygndng ds emzhiet fdzicvif gnv vn v`i dssyi no

dgcnz|nzmvdng jt zioizigci jyv% zmv`iz% vn v`i bizdvs no v`i yevdbmvi mgvdcd|mvdng fivizbdgmvdng%

mgf onz v`ds zimsng ds higizmeet yg`ie|oye `izi'

8

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DG V@I YGDVIF SVMVIS FDSVZDCV CNYZV

ONZ V@I FDSVZDCV NO FIEMXMZI

SYGN_DNG \@MZBMCIYVDCMES DGC'%

\emdgvdoo%

v'

FIT \@MZBM'% E'\'% FIT% DGC'%

BTEMG DGC'% mgf BTEMG

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Cdde Mcvdng Gn' <?"==3"E\S

NZFIZ

Mv Xdebdghvng% v`ds =0v` fmt no Kmgymzt :<=:%

Onz v`i zimsngs siv onzv` dg v`i Bibnzmgfyb N|dgdng dssyif v`ds fmvi%

DV DS @IZIJT NZFIZIF v`mv;

Jzdvds` |mvigv HJ = :40 646 dgcnz|nzmvis jt zioizigci v`i |zmcvdcme yvdedvt no v`i

cnb|nygfs fisczdjif dg v`i s|icdodcmvdng noJzdvds` |mvigv HJ = :<< 00?' Fioigfmgvs xdee ji

|izbdvvif vn |zisigv syc` bmvizdme m v vzdme ms m sdghei zioizigci dg sy||nzv no v`idz mgvdcd|mvdng

moodzbmvdi fioigsi mgf cnygvizcemdb'