WHO Drug lnforrmlion, Vol20, No. 2. 2006
`
`Proposed INN: List 95
`
`International Nonproprietary Names for
`Pharmaceutical Substances (INN)
`
`Notice is hereby given that. in accordance with article 3 of the Procedure for the Selection of Recommended lntemational
`Nonproprietai'v Names for Phamaceutical Substances. the names given in the list on the toiiovring pages are under
`consideration by he World Health Organization a: Proposed international Nonproprietary Names. The indusion of a name
`in the lists at Proposed International Nonproprieiary Names does not imply any recommendation of the use of the substance
`in medicine or pharmacy.
`
`List or Proposed (1-91) and Recommended (1—52) International Nonproprietary Names can be found in Cumulative List
`No. 11. 2004 (avalabie "1 CD—ROM oriy). The statements indicating action and use are based largely on information
`supplied by the manufachror. This information is more» meant to provide an indication of the potential use of new
`substances at thet'me they are awarded Proposed International Nonproprtetary Namee WHO is not in a position either to
`uphold these statements or to comment on the efficacy of the scion darned Because ot their orovisionai nature. these
`descriptors wil neither be revised norinchded in the CumiJative Listeot iNNs.
`
`Denominations communes internationales des
`Substances pharmaceutiques (DCI)
`ll est notitié qua. conformernent aux disposition; do i'articio 3 de la Procedure a Iuivro on we du cno‘nr de Denominations
`communes internationales reoornmandées pour les Substances phannaoeutiquea les denominations ci-dessous soul mises
`rt i'elude par i‘Organisation mcndiaie de la Santé on tant que denominations communes internationales proposées.
`L'inciusion dine denomination dans les iisiee de DC! propose” n'implique auounc recommendation on we do rutil'eation
`de la substance correspondents en médecine Dir en pharmaciei
`
`On trouvera d'autres listes de Denominations communes ritemationoies proposees (1-91) at reoorm'andees (1-52) dans
`la Uste recapitularr've No. 11. 2004 (ditponible cur cD-ROM sediment). Lee mentions indiquant las proprietes el res
`indications des substances son! romees sur les renseignernenu oommuniquéo par la tabricam. lies ne visent qu'e dormer
`une idea do l'utiiisation potentials do: nouvoiios substances au moment or] elies sent l'ohjet de propositions de DCI L'OMS
`n‘est pas en mesure de confirmer ca: declarations ni de life do comrnentairea our l‘efficacite du mode d’eciion ainsi décn‘t.
`En raison de leur condom provisoire. oes infer-motions ne figuremnt pas clans ies listes recapitulatives de DCI.
`
`Denominaciones Comunes lnternacionales para
`las Sustancias Fannacéuticas (DCI)
`Do oontorrnidad con lo que dispone ei penaro 3 del
`'Procedimiento do Seieccién de Denorn‘naciones Comunes
`lnternacionales Reoomendadas para las Sustancias Farmaoéuticas'. ac comunica por ei ore-ante anuncio qua tea
`donorninadones detaiiadas en las peginas siguientes estAn sometidas a esrudio por la Oroanuacibn Mundiai de La Saiud
`oomo Denominaciones Commas lnternacionales Propueetas. La indusibo do una denominacibn en las iiatas de las 00!
`Proouestas no suoone recomendacrbn alouna on lever dei emoieo de ta sustanoia respective en medicine 0 en tarmaoia.
`Las lists: do Denominaciones commas internaciomies Propuestas (1—91) y Rewmendadas (1-52) se encuentran
`reunidas en Cumulative List No. 11. 2004 (disponibie solo on CD-ROM). Las indie-done: sobre accion y uso qua aoareoen
`3e Dasan principaimeme en la lntormaoién tadlitada por los tabricantes. Esta intorrnacidn item: per objeto dar una idea
`fmicamentc do is: pocibiiidedes do apicacidn de las nuavas sustancias a las que se asigna una DCI Propuesta. La OMS
`no sale lacuitada para respaidar eaae indicacionee ni para tormular comentarios sobre la efrcaoia de la occién one so
`atribuye d producto. Debido a in under proveionai. esos dates descriptivos no deoen indurrse en las irstas
`mcapitulativaa de DCI.
`
`
`115
`
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`Mylan v. Regeneron, |PR2021-00881
`Page 1
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`

`WHO Drug Information. Vol.20. No. 2. 2006
`Proposed INN: List 95
`
`
`Proposed international Nonproprietary Names: List 95
`Publication date: 21 August 2006
`Comments on. or formal objections lo. the proposed names may be forwarded by any person to the INN Programme 01 the
`World Health Organization within four months of the date of their publication in WHO Drug lamination.
`i.e.. for List 95
`Proposed INN not later than 21 December 2008.
`
`Denominations communes internationales proposées: Liste 95
`Dale do pubiication:21 301112006.
`Des observations on dos objections fem-relies a regard des dénominations proposées peuuent stre adressées par mute
`personne au Programme des Denominations communes internallonales de I'Drganisation monoiale de la Santé dans Lin
`délai do quatre mois a oompter de la dale de leur publication dans two Drug lnfonnanon, o'eat a dire pour la Lists 95 do
`DCI Proposes; re 21 decembre 2006 au plus lard.
`
`Denominaciones Comunes lnternacionales Propuestas: Lista 95
`Fecha de la publicaculn: el 21 de agosto de 2006
`Cualquier persona puedo din'gir observaciones u objeciones respecto de las denominaciones propueslas. 31 Programa de
`Denominaciones Comunas lnlernacionales de la Organizadon Mundial de la Salud. en un plaza ds cuatro meses. conlados
`desde la lecha de su publioacion an WHO Drug infomation. as dean. para la Lists 95 do DCI Propuestas at 21 da
`diciembre de 2006 a male tardar.
`
`Proposed lNN
`(Latin. English. French. Spanish]
`
`cnemmal name ordascnpllon: Action and use: Molecular formula
`Cheml'oalAbslraa-ls Service {GAS} registry number Graphik: {annals
`
`Nam chlmlque or: descfiplion: Propriétés of indications: Formula brule
`Numéro darts is regime (in GAS: Formula déweloppos
`
`Hombre quimico o descripcion: Accidn 5! non: Fannula molecular
`Ndmsm do rapislro do! GAS: Fomula desan'ollada
`
`immunoglobutin G1. anti—idiohioe anti-[anli-[Homo sapiens oanoer
`antigen 125. CA 125. MUG-13) Mus museum: monoclonal antibody
`OC125} Mus musculus monoclonal antibody ACM 25. clone 305
`gamma1 heavy chain disulfide with clone 305 Kappa light chain;
`(223-223":226-226":223-22B") lrisdisulfide dimer
`immunological agent. anrmoplaslk'
`
`immunoglobuline G1, anli-idiolype anti-[anti-(Homo saoiens osnoer
`antigen 125, CA 125, MUG-16) antimrps monoclonal murin OC125]
`antioorps monoclonal munn acmzs. chalne lourde gamms1 do
`clone 305 unle par un pont disulfure a la ohaine légére kappa du
`done 305: dimére {223-223".226-225":228-22B")-trisdlsulluro
`agent immunologloue, enlinéoplasique
`
`inmunoglobuilna G1. snti-idiolipo anti-{anti—[Homo saplons cancer
`antigeno 125. CA 125. MUG-15) anll'cuarpo monoclonal murino
`061 25] anticuerpo monoclonal murino ACA125, oadena pesada
`gamma1 del clon 3D5 unida por un puonte disulfuro a la cadena
`iigera kappa del (“Jon 305. (Simon: (223-223":226-226“:228-228")-
`lrisdisuiluro
`agents inmunologico. antineoplasico
`
`no: Proposes
`
`DC! Pmpuesla
`
`abagovomabum'
`abagovnmb
`
`abagovomab
`
`abagovomsb
`
`11S
`
`Mylan Exhibit 1040
`Mylan v. Regeneron, |PR2021-00881
`Page 2
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`Mylan Exhibit 1040
`Mylan v. Regeneron, IPR2021-00881
`Page 2
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`

`

`Proposed INN: List 95
`WHO Drug Intorrnatian. Vol.20, Na. 2. 2006
`—._—.__————
`
`50
`1W
`159
`50
`3“?
`’50
`400
`
`M1
`
`M 1
`
`120
`ISO
`“4
`
`?92921-1 0-9
`
`Heavy duiniChul‘ne fourdchadnn-I panda
`LARPEMVKL
`SCKRSGYTE‘T
`QVKLQESGA}:
`THKFKGKATL
`TADKSS STAY
`3mm DGNTRY
`KTTP FEW PL
`Gumwruwc
`UGTTV TVSSR
`NSGSL SSGVH
`YFE‘E gvrww
`'1' F?AVLQS 3 L
`cmmmssr
`KVDEGQV PRO
`CGCK PC ICTV
`F5?! FVDDVEV
`LT nmcwv
`D I 3 KO!) PEVQ
`NGKEFKCRVN
`SM? PAPI BK
`ELPEHHQWL
`LTCHITDE‘PP
`EDI TVEHQRN
`KEGHAKDKVS
`CSVLHEGLHN
`5N" EMGNTFT
`wrsxwvox
`
`Light chainfChnllle iégérdCadena ligcra
`DIEL'I'IJS PAS LSASVGSTV‘I
`ITCQASENI‘!
`AKTLAGGVSS RESGSGSGTH FSLKKKSLQP
`GTKLEIKRJ'LD MPTVSIFPP SSEQLTSGGA
`DGSERQNGVL NSWTDQDEKD STYSMSSTLT
`STSPIV‘KSFN RNEC
`
`My mom: ma
`HOLSSLAS 3D
`HPGSMQT‘NS
`YTLSSSV‘TVP
`E‘BU’SENFE F‘P
`HTHQTQPREE
`TI SK‘TKGR PK
`SQ PAENYICNT
`HH'I'E KSLS Hs
`
`9595mm; an
`ssvwcmsa
`m7 LSC was
`ss’mpss TV'J‘
`PK mourn!
`omsrrksvs
`APQVYTI PPP
`QPIMD‘I‘DGS‘!
`PGK
`
`SYLAWHGQKQ
`ED'E‘G I YYC 9H
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`Lm£¥ERHN
`
`5K5 POL LWN
`HYG ILE‘T EGG
`PKDIWKWKZ
`SYTCERTHK'I‘
`
`(arm-1 5-[4-[mlliodoph enyila-mefl'lylperltadecanaic acid
`radiophannaceumar
`
`acids (aRaj-15-{4-['mllioduphénfl-a-mémwpentadécanoique
`radiaphannaceufiqus
`
`acido (may-15-{4{‘“Iliodorenm-a-metilpentadecanaioo
`preparamn (armacemr‘ca radiaclr'va
`
`Cans‘zaloz
`
`123348-5184
`
` {123'}
`
`
`
`el énemiomére
`y anamiémero
`
`(af:1-3-[[hydroxyJaim'llophen-Z-yllacetyloxyl—1—[3-phenoxypmpyl)—
`1A. azabicyclo[2.2.2]octan—1-ylium bromide
`muscan'm‘c receptor antagonist
`
`bmmure de {am-34mmrexybisahiophénlzylhcézynmfl-
`1~(3-1:hénoxypropyl)-1 amniabicyclolz 2.210ctane
`antagonism ties récepfeurs muscan'niques
`
`bugmum rte (am-1 ~(3arenoxipropiI)-3-{(hidrofimitfiofen-E-inacetilnm}
`13. -azabidcla[2.2.2]octan-1-ilio
`antagonist: the {as receptares muscannm
`32034 5-99-1
`
`ngH “WHO‘S;
`
`acidum indomtlcum {‘“n
`maniac acid ("an
`
`aside iodofiltique (ml)
`
`was iodofiflion ("’I)
`
`aclidinii hmrnldum
`adidinlurn bromide
`
`_ bromure d'adidinium
`
`bromuro de aclidinia
`
`
`
`Mylan Exhibit 1040
`Mylan v. Regeneron, |PR2021-00881
`Page 3
`
`Mylan Exhibit 1040
`Mylan v. Regeneron, IPR2021-00881
`Page 3
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`

`WHO Drug Intonation, Vol.20, No. 2. 2006
`Proposed iNN: List 95
`
`
`4-11{4-[2-(dimethyiamino)ethoxy]pheny1}-2-phenylbut~1-enyl)phenoi
`antisstmgen
`
`4-[1 —[4-[2-{diméthyla minolélhoxylp hényfliz-phe nylbut-1 -ényl]phéncl
`ani‘ioestmgene
`
`4-[1—[4-[2-(d|metiiaminoietoxilfenill-Z-l’enilbut-1-enil]fenol
`enriesrrdgeno
`
`CanN 02
`
`68 392-353
`
`H=C
`
`\
`
`0% firm.
`CH3
`
`O
`OH
`
`and Z learner
`et l‘isornére Z
`yat isdrrlera 2
`
`dos-4 SZ-Iysin e-[hurnan vascular endothelial growth ia ctor receptor
`
`
`{1 (193-2134)-peptide (containing [9-like 02-type 2 domain) fusion
`
`
`protein with human vascular endothelI'ai growth factor receptor
`
`*2-12064308)-peptide (qontaining[9--like cz-type 3 domain fragment]
`
`ifuslion protein with humanrrnrnun I_obulin Git-(22? Cterminal:a
`'_I'85ldl_.les)-pep—tide(F_ctragm___ent)].i{211‘vz11'1'214-2141-bi5disulfide
`Idimer
`Fingiggenesis inhibiroa
`(211-211‘1214—214’J-bisdisuifura du dirnére de la dés-432Jysine-
`[réoepteur 1 humain du iacteurde cmissanoe endothellal vasculaire-
`(103-204)vpeptide (contenanl Ie dcmaine Ig-like (DZ-type 2} proteine
`de fusion aver: Be récepteur 2 humain du facteur de croissance
`endothélial vasculaire—(206-303)-pepiide (cuntenant un fragment du
`domine lg—like cz-type 3) protéine de fusion avec
`I’immundglohulina G1 humaine—(ZZ? residus oterminaux)-peptide
`[fragment Fc)]
`inhibit-w! die iiangibgénese
`
`[211-211':214~214'}-bisdisumro del dimero de la des-432-iisina.
`{receptor 1 humane del tactur de crecimientn endatehal vascular-
`[103v204)-peptida {que no nliene el dominio lg-iike Ci-tipu 2)
`proteina de fusidn con el receptor 2 hurnano del factor de
`crecimianto endotelial vascular-(ZOE-SOBJ-pépiido (qua mntlene un
`fragmenm del dominio ig—like C2-tipo 3} pronelna de Iiisién con la
`inmunoglcbulina Gi humans-(22? restos C-terrninaie31-peptida
`(fragme nto Fc}}
`inhibidor d5 ia angiogenesi's
`
`afi rn when u n1
`afimoxiiene
`
`afimoxiféne
`
`afimcxifeno
`
`
`rafllbercaptumi
`raI'Iitaizrcep_,t
`
`anibercept
`
`afiibemept
`
`118
`
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`Mylan v. Regeneron, |PR2021-00881
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`Mylan Exhibit 1040
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`

`Proposed INN: Us! 95
`WHO Drug Information, Vol.20. No. 2, 2006
`
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`qwnmnmm CPPCPAPSLL @595.erer KPKD‘thzsa TPswcwv _
`ivSHEDPEVKr-wiwwocvaw unmxpaazo msnkwsv LMHQD‘JLH'
`{GREYKCKVSN' MLPAPIEK‘P ISKAKGOPFE POVYTLFFSB DELTKNCWSL '.
`ficwasrws nuvswssus OPSNNYKTTP PELQSDGSH-L LrSKL-wgksf
`tny'qqgquSCfiW-uiguam ”055151.593;
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`
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`
`aloglltazarurn
`alegiitazar
`
`aléglilazar
`
`aleglilazar
`
`alfarminogenurn tadanovecum'
`alferminagene ladenovec
`
`alterrnino-géne tadénovec
`
`alfen'ninogén ladenmc
`
`(2S}-2-methoxy-:H4-[2—(5—methyl-2-phenyI-T .3-oxazoI-4-y|)ethoxy]-
`1-benmtniaphen-T-ynpropa noic add
`anfidiaberr'c
`
`acide (ZSJ-Z-meih axy-a-[4-[2-(5-rnéthy§-2-phényl-1 ,3-oxazol-4-yl)=
`élhoxyl-1-benzofl1iaphen-7-yllpropanchue
`antidiabéffque
`
`acido (‘25)45-{4-[2—{2-fenil-1,avoxamI-imetil-dr-illefox}
`1-benzotiofen-7.il}-2-meiompropanoicn
`hjpoglucemianre
`CuflasNos-S
`
`4754?9-34-6
`
`N
`
`©_</ f/0
`
`CH3
`
`o
`
`cozH
`
`Recombinant human adenovirus 5 (replicationodeflcient. E1-deleled)
`containing a human fibroblasl growth teeter-4 cDNA sequence driven
`by a cytomegalovirus grammar
`gene therapy product - simmers: angiogenesr's
`
`adénovirus 5 hurnain recombinam (réplicallonidéficienl,
`régian E1-suppriméa) mntenanl la séquence ADM-Danie du
`facaeur 4 de croissance du fibrobiaste humain sous oonlrdle d’un
`promoteur de cytomégaiouirus
`produit do thémpie génfque sfimulafeur de l'angiogenése
`
`adenovirus 5 humane recombinant: (replicaciOn-deficiente. can
`deieccion E1} que confiene la secuencia BNA—mpia del factor-4 de
`mmiento de fibroblastas humane: oontrolado por un promoter de
`citomega‘ovirus
`producfo para genofsrapia.esflmuranre de la angiogénesis
`4?3553»86-5
`
`Mylan Exhibit 1040
`Mylan v. Regeneron, |PR2021-00881
`Page 5
`
`Mylan Exhibit 1040
`Mylan v. Regeneron, IPR2021-00881
`Page 5
`
`