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`This is an Open Access article under the CC BY license.
`
`MYLAN EXHIBIT - 1015
`Mylan Pharmaceuticals, Inc. v. Bausch Health Ireland, Ltd. - IPR2022-00722
`
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`pd]p ^ej` uap `k jkp ]_per]pa ]`ajuhuh _u_h]oa*
`Pdeo opq`u kb pda aha_pnkop]pe_ ejpan]_pekj kb pda ^]oe_ naoe)
`12
`17
`18
``qao Huo ( =nc ( ]j` =nc
`kb chq_]ckj sepd ]_e`e_ naoe`qao kb
`pda chq_]ckj na_alpkn eo ^]oa` kj pda oqllkoepekj pd]p ]ju kja
`kn ]hh kb pdaoa cnkqlo i]u lnkre`a ] _kqjpanekj pk ] ola_ebe_
`]ol]npe_ ]_e` naoe`qa kj pda atpn]_ahhqh]n `ki]ej kb pda na_al)
`pkn pd]p d]o ^aaj odksj ej na_ajp iqp]cajaoeo opq`eao pk ^a
`_nepe_]h bkn hec]j` na_kcjepekj $-1( -4%* Pda eilknp]j_a kb deope)
``eja ]p lkoepekj - pk ^kpd na_alpkn ^ej`ejc ]j` ]_per]pekj d]o
`^aaj benihu aop]^heoda` $5 ®-.%* Naikr]h kb pda deope`eja cnkql
`]bbkn`a` ]j ]j]hkc pd]p nap]eja` ]bbejepu bkn pda na_alpkn ^qp(
`ikna eilknp]jphu( ]lla]na` pk l]npe]hhu ejde^ep chq_]ckj)opei)
`qh]pa` ]`ajuhuh _u_h]oa $5%* =hpdkqcd pda J)paniej]h deope`eja
`eo opne_phu _kjoanra` sepdej pda chq_]ckj b]iehu kb lalpe`a
`12
`17
`18
`dknikjao( Huo ( =nc ( ]j` =nc
`]na nah]perahu qjemqa ]p
`pdaoa lkoepekjo ej chq_]ckj ]j` iecdp ]hok oanra ]o `apanie)
`j]jpo kb na_alpkn ola_ebe_epu*
`Pda naoqhpo kb kqn opq`u nara]h pd]p sdeha jaqpn]h naoe`qa
`o_]jjejc kb lkoepekjo -.( -3( kn -4 kb chq_]ckj opnkjchu ]ppaj)
`q]pa` na_alpkn ^ej`ejc( ikop kb pda naoqhpejc ]j]hkco sana
`sa]g ^qp bqhh ]ckjeopo( oqccaopejc pd]p ] lkoepera _d]nca ]p
`pdaoa l]npe_qh]n lkoepekjo s]o jkp ]^okhqpahu _nepe_]h bkn ]_per)
`epu* Pd]p jk lkoeperahu _d]nca` ]iejk ]_e`o kb chq_]ckj( sepd
`pda at_alpekj kb deope`eja -( ]na _nepe_]h bkn pda ]_per]pekj bqj_)
`pekj eo ej`e_]pa` ^u pda k^oanr]pekj pd]p jkja kb pda nalh]_a)
`
`glucagon H SOO T F T SD V SK Y LD SR R A 0 D F VC) LM NT -
`glpl HIAEG T F T SDV SSY L EGG A A KEF I AW LV KG R
`secretin HSDG T F T SE L SR LOD SAR L OR L LQG LV
`vip HSDAV F TDNY TR LRKQMA V KKY LNS I L N--
`
`Consensus HSDG T F T SD SR
`
`D
`
`A
`
`F LQ LV
`
`BEC* .* :BMQBJ@B >HFDJIBJP KC LBLPFABO KC PEB DHQ@>DKJ C>IFHU
`PE>P E>RB @HKOB EKIKHKDU$ Naoe`qao pd]p ]na _kjoanra` ej aepdan
`_d]nca kn du`nkldk^e_ _d]n]_pan ]na @LTCB*
`
`iajp ]j]hkco ej P]^ha E ^ad]ra` ]o ]jp]ckjeopo* Dksaran(
`1
`okia kb pda _knnaolkj`ejc `ao)Deo `aner]perao kb lkoepekjo -3
`]j` -4 nalh]_aiajp ]j]hkco `eolh]ua` l]npe]h ]jp]ckjeop lnkl)
`anpeao( sde_d s]o pdanabkna ]ook_e]pa` sepd pda `ahapekj kb
`lkoepekj - deope`eja $/-%* Pdaoa sana ej pda $E+=%
`n]jca kb
`50
`/0 ® 41( sdana]o pda ikop lkpajp chq_]ckj ]jp]ckjeop nalknpa`
`pk `]pa s]o ,*41 $/2%*
`= jac]perahu _d]nca` ]_e`e_ ]iejk ]_e` s]o( dksaran( haoo
`pkhan]pa` ]p pdaoa lkoepekjo ]j` eil]ena` na_alpkn ^ej`ejc ^u ]
`dqj`na`)bkh` kn ikna* Opnkjchu na`q_a` ^ej`ejc ]bbejepeao sana
`_kqlha` sepd ]`ajuhuh _u_h]oa naolkjoao sepd iq_d sa]gaja`
`lkpaj_eao* Pdqo( ] lkoepera _d]nca ]p pdaoa lkoepekjo eo ja_ao)
`o]nu bkn klpei]h dknikj]h bqj_pekj*
`Kqn lnarekqo bej`ejco aop]^heoda` pda nkhao kb pda ]ol]npe_
`9
`]_e` naoe`qao ]p lkoepekjo 5( -1( ]j` .- kb chq_]ckj* =ol eo
`_nepe_]h bkn pn]jo`q_pekj ^qp jkp bkn ^ej`ejc $3%( sdana]o pda
`15
`jac]pera _d]nca ]p =ol eo ]^okhqpahu aooajpe]h bkn ^ej`ejc $4%*
`Ej _kjpn]op( pda lkoeperahu _d]nca` naoe`qao ej pda _ajpn]h na)
`cekj kb pda dknikja d]ra ] ola_ebe_ nkha ej ]_dearejc klpei]h( kn
`araj oecjebe_]jp( ^ej`ejc ]j` i]tei]h ^ekhkce_]h lkpaj_u* =j
`]hpan]pekj ej pda _d]nca `eopne^qpekj ]hkjc pda ikha_qha _ha]nhu
`naoqhpo ej `a_na]oa` ^ej`ejc kb pda `aner]perao* Qjhega lkoe)
`pekjo 5 ]j` -1 sdana pda lna_eoa hk_]pekj kb ]j ]ol]npe_ ]_e`
`naoe`qa eo _nepe_]h pk dknikja)na_alpkn ejpan]_pekj( ep ]lla]no
`pd]p chq_]ckj ^ej`ejc ]bbejepu eo jkp nacqh]pa` ^u pda pklk)
`cn]lde_ hk_]pekj kb ] ola_ebe_ lkoepera _d]nca ^qp ^u ] jap lko)
`epera _d]nca* =j kran]hh lkoeperahu _d]nca` ikha_qha `abejepahu
`ajd]j_ao pda ]bbejepu bkn epo iai^n]ja)^kqj` na_alpkn lnkpaej*
`= oejcha nalh]_aiajp ej chq_]ckj ]ie`a sepd ]j qj_d]nca`
`naoe`qa `e` jkp ]`amq]pahu ]hpan pda kran]hh _d]nca pk na`q_a
`
`

`

`-,/-.
`
`2IQA?ELK ;PNQAPQNC ?KB 1QKAPGLK
`
`^ej`ejc ]j` ]_perepu( ^qp kja oq^opepqpekj sepd ] jac]perahu
`_d]nca` naoe`qa naoqhpa` ej ] jaqpn]h ikha_qha*
`Oa_napej( CHL)-( ]j` r]ok]_pera ejpaopej]h lalpe`a( chq_])
`ckj#o _hkoaop nah]perao sepdej pda b]iehu kb lalpe`a dknikjao(
`od]na 1,! oamqaj_a dkikhkcu ikophu ]p pda J)paniej]h d]hb kb
`1
`pda ikha_qha $Bec* .%* Sepd pda at_alpekj kb Deo ( pda lkoepekjo
`kb ^]oe_ naoe`qao o_]ppana` lnei]nehu ]hkjc pda ?)paniej]h l]np
`kb pdaoa oamqaj_ao ]na jkp sahh _kjoanra`* Ej ]j a]nhean nalknp(
`] chq_]ckj)CHL)- _deiane_ lalpe`a( ej sde_d pda benop -0 naoe)
``qao kb chq_]ckj sana _ki^eja` sepd pda h]op -2 naoe`qao kb
`CHL)-( ^kqj` pk ^kpd chq_]ckj ]j` CHL)- na_alpkno $/5%* Pda
`jkni]h lalpe`ao kjhu ^ej` sa]ghu pk a]_d kpdan#o na_alpkn*
`Ejpanaopejchu( sd]p ]lla]no pk ^a lnaoanra` eo ]j kran]hh lkoe)
`pera _d]nca( oqccaopejc pd]p ] lkoeperahu _d]nca` hec]j` i]u ^a
`kja namqeoepa ba]pqna _kiikj pk iai^ano kb pdeo C lnkpaej)
`_kqlha` na_alpkn oq^)cnkql ]j` pdanabkna jkp ] opne_p `apanie)
`j]jp kb ola_ebe_epu*
`Pda opq`u ]hok nara]ho ] du`nkldk^e_epu _kilkjajp kb pda
`^ej`ejc ejpan]_pekj* Pda ^]oe_ ]iejk ]_e`o ]ncejeja ]j` huoeja
`_]j _kjpne^qpa jkp kjhu ] _d]nca` cnkql ^qp ]hok ]j ]held]pe_
`_kilkjajp pk pda lkh]n ]j` jkj)lkh]n ejpanb]_a kb pda hec]j`
`^ej`ejc lk_gap* Pda lnklkoa` hec]j` ^ej`ejc oepa odkqh` hea
`sepdej ] du`nkldk^e_ _kna kb pda na_alpkn sdana jkjola_ebe_
`du`nkldk^e_ ejpan]_pekjo ^apsaaj pda dknikja ]j` epo na_alpkn
`ai^a``a` ej pda iai^n]ja ^eh]uan ]qciajp ^ej`ejc ]bbejepu*
`Pdeo atlh]ejo sdu oq^opepqpekj sepd ] jaqpn]h uap du`nkldk^e_
`ikha_qha hega ]h]jeja kn haq_eja s]o sahh pkhan]pa` `aolepa pda
`hkoo kb ] lkoepera _d]nca ]j` _kqh` oqop]ej /, ® 2,! kb pda
`]bbejepu bkn pda na_alpkn* = narano]h kb _d]nca kj pda kpdan d]j`
`]`ranoahu ]hpana` pda lkh]n _d]n]_pan kb pda lalpe`a ]j` ha` pk
`] cna]pan hkoo kb na_alpkn na_kcjepekj $P]^ha EE%* Jaranpdahaoo(
`]j ej_na]oa` du`nkldk^e_ _kjpne^qpekj bnki ] chqp]ie_ ]_e`
`oe`a _d]ej lnk^]^hu _kilajo]pa` bkn pda narano]h kb _d]nca ]j`
`]__kqjpa` bkn pda napajpekj kb oq^op]jpe]h ^ej`ejc ]bbejepu ]j`
`17
`18
`lkpaj_u kb pda Chq
`]j` Chq
`nalh]_aiajp ]j]hkco $]j]hkco
`1
`17
`.0 ]j` .4( P]^ha EE%* Ej ]``epekj( `ao)Deo (Chq
`$]j]hkc .1(
`P]^ha EE%( sde_d nap]eja` .! ^ej`ejc ]j` ] sa]gaja` lkpaj_u
``qa pk `ahapekj kb deope`eja( s]o opehh ] l]npe]h ]jp]ckjeop* Pda
`17
`18
`21
`]j]hkc WHuo (Huo (Chq Ychq_]ckj d]o ^aaj nalknpa` pk ^a ]
`oqlan]ckjeop sde_d ^kqj` 1)bkh` ^appan pd]j pda j]pqn]h dkn)
`ikja ]j` d]` ] decdan lkpaj_u $-5( .,%* = na_ajp t)n]u _nuop]h
`17
`18
`21
`opnq_pqna bkn WHuo (Huo (Chq Ychq_]ckj oqccaopa` pd]p pda
`18
`bkni]pekj kb ] o]hp ^ne`ca ^apsaaj pda )]iejk cnkql kb Huo
`E
`21
`]j` pda _]n^ktuh kb Chq i]u op]^eheva pda pqnj kb ] lqp]pera
`)dahet ]p naoe`qao -4 ®.- ]j` _kjpne^qpao pk epo oqlan]ckjeop
`]_perepu $.-%* Dksaran( ^ej`ejc ]bbejepu nai]ejo nah]perahu decd
`araj sdaj du`nkldk^e_ naoe`qao ]na oq^opepqpa` bkn aepdan
`17
`18
`=nc
`kn =nc * Lnaoqi]^hu( ajd]j_a` ]_perepu i]u ]hok ^a
`]ppne^qpa` pk pda ej_na]oa` du`nkldk^e_epu kb pda hkjcan ]he)
`ld]pe_ oe`a _d]ejo kb huoeja ]j` chqp]ie_ ]_e` nah]pera pk pdkoa
`kb pda jkni]h ]ncejeja ]j` ]ol]npe_ ]_e` naoe`qao*
`17
`12
`Pdqo( pda lkoeperahu _d]nca` ]iejk ]_e`o Huo ( =nc ( ]j`
`18
`=nc
`kb chq_]ckj d]ra h]nca abba_po ^qp ]na jkp ]^okhqpahu
`_nepe_]h bkn pda ^ej`ejc ]j` ]_per]pekj bqj_pekj kb pda dknikja*
`Dksaran( pda bqj_pekj]h cnkqlo kb pdaoa ^]oe_ naoe`qao ^khopan
`^kpd pda lkh]n ]j` jkj)lkh]n ]ola_po kb pda lalpe`a ]j` lnkpaej
`ejpan]_pekjo pd]p k__qn sepdej pda na_alpkn ^ej`ejc oepa ]j`
`ajoqna i]teiqi ^ekhkce_]h ]_perepu* Pda ]held]pe_ ^]_g^kja kb
`]ncejeja ]j` huoeja naoe`qao klpeieva hec]j` §beppejc· sepdej ]
`du`nkldk^e_ lk_gap ej pda na_alpkn* Kqn `]p] `aikjopn]pa pd]p
`]p pdaoa lkoepekjo ej chq_]ckj( jkjola_ebe_ du`nkldk^e_ ejpan)
`
`]_pekjo ]na ]o eilknp]jp ] _kjpne^qpejc b]_pkn pk ^ej`ejc ]bbej)
`epu ]o pda aha_pnkop]pe_ abba_po* Iqp]cajaoeo opq`eao kj pda
`na_alpkn d]ra kqpheja` pda laneiapan kb ] lqp]pera ^ej`ejc oepa
`^kn`ana` ^u jac]perahu _d]nca` naoe`qao* Pdqo( ]j kran]hh lko)
`eperahu _d]nca` chq_]ckj ikha_qha _kjpne^qpao pk pda op]^ehev])
`pekj kb pda dknikja)na_alpkn _kilhat ]j` oa_qnao pda ^ej`ejc
`_kjbkni]pekj pd]p oq^oamqajphu ha]`o pk ]_per]pekj*
`
`NABANAJ?AO
`
`-* Fahejag( H* F*( Hkg( O*( Nkoaj^anc( C* >*( Oiepd( N* =*( Cn]jp( B* F*( >ecco( O*(
`>ajo_d( L* =*( Gqeblan( F* H*( Odall]n`( L* K*( Olna_dan( ?* =*( K#D]n]( L* F*(
`Bkopan( @*( S]hgan( G* I*( ?daj( H* D* F*( I_ganj]j( L* =* " Gej`orkcah( S*
`$-55/% ;AGCKAC '*." -2-0 ®-2-2
`.* Oacna( C* R* " Ckh`nejc( O* N* $-55/% <NCKBO 0KBLANGKLI% 6CP?@% )" /,5 ®/-0
`/* Pdknajo( >* I* $-55.% 9NLA% 7?PI% ,A?B% ;AG% =% ;% ,% -." 420-® 4202
`0* Eoded]n]( P*( J]g]iqn]( O*( G]venk( U*( P]g]d]ode( P* P]g]d]ode( G* " J]c]p](
`O* $-55-% 06-8 5% &%" -2/1®-20-
`1* Qo`ej( P* >*( Iaoau( A*( >qppkj( @* ?*( >nksjopaej( I* F* " >kjjan( P* F* $-55/%
`0KBLANGKLILEU &((" .42-®.43,
`2* Eoded]n]( P*( Odecaikpk( N*( Ikne( G* " J]c]p]( O* $-55.% 7CQNLK -" 4--® 4-5
`3* Qjokj( ?* C*( I]_`kj]h`( @*( N]u( G*( @qnn]d( P* H* " Iannebeah`( N* >*

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