Sikhatsi lesidze, bantfu bebakholelwa kutsi sakhiwo setimangalo singakhona futsi sivame kudlala indzima lejubako ekumangaleleni patent. Loku kukhuluma ngalokucondzile kusisekelo sekutsi i-Federal Circuit icinisekise sincumo senkantolo yesigodzi lemelene nemkhiciti wemitsi levamile esijubeni sakamuva se-Pharmacopoeia yeSigodzi ecaleni le-Par Pharmaceutical, Inc. Kwephulwa kwefomula yaPar lenelungelo lobunikati, emazinga eliphutsa lacacile nawo abe nemtselela emiphumeleni.
Letinkinga tabangelwa licala le-ANDA, lapho khona ummangali afuna khona Nombolo ye-Hospira yaseMelika lengu-9,119,876 kanye na-9,925,657 mayelana ne-Adrenalin® yaPar (adrenaline) kanye nendlela yayo yekuyiphatsa (umjovo). Hospira wakhutsata kungaphuli umtsetfo kanye nekungasebenti njengetindlela tekuvikela (inkantolo yesigodzi yafaka sicelo sekuvikela Hospira ngako-ke ayizange idvonse sicelo). I-Par patent ihloselwe kwakheka lokuncoba kushoda kwekwakheka kwe-adrenaline yebuciko bangaphambilini. Ngenca yetindlela letintsatfu letehlukene tekubola (i-oxidation, i-racemization kanye ne-sulfonation), imphilo yayo yeshelufu imfisha kakhulu. Simangalo 1 se-'876 patent simele:
Kubunjwa lokufaka: cishe 0.5 kuya ku 1.5 mg/mL we epinephrine kanye/noma luswayi lwayo, cishe 6 kuya ku 8 mg/mL wemlawuli we-tonicity, cishe 2.8 kuya ku 3.8 mg/mL we-ejenti lekhuphula i-pH, kanye ne-antioxidant lecishe ibe ngu-0.1 kuya ku-1.1 mg0ring1 kuya ku-1. mL/mL kanye na 0.01 kuya ku 0.4 mg/mL mL we insimbi yekugucuka lehlanganisako, lapho khona le antioxidant ifaka ekhatsi i-sodium bisulfite kanye/noma i-sodium metabisulfite.
(Sebentisa umbhalo lobhalwe ngesibindzi embonweni kukhombisa imikhawulo lephatselene nekudvonsa sicelo saHospira). Ngemuva kwekuchaza lemikhawulo, lombono waphakamisa inchazelo yeligama lelitsi “sivumelwano” lelisetjentiswa yinkantolo yesigodzi kumkhawulo ngamunye. Laba labatsintsekako bavumelene ngalokucacile kutsi leligama kufanele libe nenshokutsi yalo levamile, letsi “mayelana”; ngeNkantolo Yekudvonsa Ticelo Yesifundza Sembuso, Hospira akazange anikete inchazelo lephikisana naloko.
Bobabili laba banikete bufakazi bebungcweti ngalemikhawulo lemitsatfu lengenhla. Tingcweti taParr tafakaza kutsi inkantolo yasebentisa 9 mg/mL sodium chloride kute itfole kwephulwa kwemtsetfo esigabeni se-6-8 mg/mL (Hospira lokucuketfwe, noma ngabe lokucuketfwe lokuphansi njenge-8.55 mg/mL nako kuyasetjentiswa) ngoba Kwanele kuhlangabetana nenjongo lehlosiwe kutsi limainta in . i- adrenaline ingene engatini.” Tingcweti taHospira taphakamisa kuphela kuphikiswa kubalingani bakhe kutsi ngabe bochwepheshe bakhe labanelikhono bakholelwa kutsi 9 mg/mL iwela ngaphansi kwe “cishe” 6-8 mg/mL.
Mayelana nemikhawulo yetinhlanganisela tensimbi tekugucuka, inkantolo yesigodzi yafakazela kutsi i-citric acid yi-ejenti leyatiwako ye-chelating lesekelwe ebufakazini. I-Hospira yasho ku-ANDA yayo kutsi lokucuketfwe kungcola kwetintfo (tinsimbi) kungekhatsi kwemazinga emhlaba wonkhe (ikakhulukati ICH Q3D) Imihlahlandlela). Tingcweti taPar tafakazela kutsi budlelwane lobuhambisanako emkhatsini wemkhicito lojwayelekile kanye nekuhlanganiswa kwe-ejenti ye-chelating yensimbi leshiwo etimangalweni kusesigabeni lesidzingekako. Tingcweti taHospira taphindze futsi atizange tincintisane netingcweti taPar jikelele, kepha kwafakazela kutsi umkhawulo longetulu welizinga le-ICH Q3D bekulizinga lelingakafaneli lenkantolo yesigodzi. Esikhundleni saloko, ukholelwa kutsi inani lelifanele kumele likhishwe ku Hospira's test batch, lekholelwa kutsi itawudzinga emazinga laphansi kakhulu e citric acid njenge chelating agent.
Lamacembu lamabili ancintisana kusebentisa i-ejenti lehlisa i-pH i-ANDA ya Hospira kwentela kucacisa lokucuketfwe kwe citric acid njenge buffer (ne sodium citrate yayo). Ensimini, i-citric acid yona ngekwayo itsatfwa njengalekhulisa i-pH (futsi akungabateki kutsi i-citric acid yona ngekwayo yi-A pH lehlisa i-ejenti). Ngekusho kwetingcweti taPar, kususa linani le citric acid kulefomula ye Hospira kwanele kwenta le citric acid iwe ngaphansi kwelibanga le pH lehlisako leshiwo ngu Par. “Ngisho nalawo ma-molecule lafanako e-citric acid atawuba yincenye yeluhlelo lwekuvikela (i-Citric acid ne-sodium citrate lehlanganisiwe isetjentiswa ndzawonye njenge-ejenti lekhuphula i-pH.”(Nanobe kunekuphikisana lokusobala, khumbula kutsi kwephula umtsetfo kuyintfo lekhonako. Tingcweti taHospira ativumelani netingcweti taPar futsi tifakazele (ngendlela lenengcondvo) kutsi emamolekhyuli e-citric acid kulekwakheka akukafaneli atsatfwe njengalawo lanciphisa i-pH kanye nekukhulisa i-pH Nomakunjalo, inkantolo yesigodzi yancuma kutsi Par wancoba lelicala futsi siphakamiso saHospira sitawuphula lilungelo le-patent laPar.
Lijaji Taranto bekakholelwa kutsi i-Federal Circuit yacinisekisa kutsi Lijaji Dyke neLijaji Stoll nabo bebakhona kulomhlangano. Sikhalazo saHospira besifaka ekhatsi sincumo senkantolo yesigodzi ngayinye yalemikhawulo lemitsatfu. I-Federal Circuit yacala kucinisekisa lokutfolwe yiNkantolo Yesigodzi ngemibono yayo kutsi lokucuketfwe kwe-9 mg/mL sodium chloride ekwakhiweni kwe-Hospira empeleni kuwela ngaphansi kwemkhawulo “locishe ube ngu-6-8 mg/mL lofunwa nguPar. Lelicembu letingcweti laveta kutsi uma usebentisa ligama lelitsi “cishe”, “gwema kusebentisa imincele lecinile yetinombolo yemikhawulo lecacisiwe,” kusho i-Cohesive Techs. v. I-Water Corp., 543 F. 3d 1351 (I-Fed. Cir. 2008), lesekelwe ku-Pall Corp. Kucaphuna sitatimende seMonsanto Tech, uma “mayelana” kuguculwa etimangalweni, libanga letinombolo letifunwako linganwetshwa ngale kwelibanga kuze kube ngulapho umuntfu lonelikhono “atawucabanga ngendlela lenengcondvo” ngebubanti lobumbonywe ngulesimangalo. LLC v. EI DuPont de Nemours & Co., 878 F.3d 1336, 1342 (Inkantolo Yembuso 2018). Etimeni letinnjalo, uma ngabe kute licembu lelikhutsata kunciphisa bubanti besimangalo, kuncuma kusekelwe esigabeni sekuhlangana. Tintfo talelizinga tifaka ekhatsi kutsi ngabe lefomula lesolwako yekwephula umtsetfo “ilinganiselwe” kusuka esigabeni sekuvikelwa (Conopco, Inc. v. May Dep't Stores Co., 46 F.3d 1556, 1562 (Inkantolo Yembuso, 1994). )) , Futsi kubaluleke kangakanani kuvikelwa kwemkhawulo wenjongo yanyalo ku) yona ngekwayo. Nanobe ivuma kutsi lesimangalo sifaka sandla esincumweni senkantolo ngalendzaba, i- Federal Circuit yaveta kutsi: “Kutsi ngabe lentfo yemmangalelwa ihlangabetana nenshokutsi “yesivumelwano” lesinengcondvo yini ngaphansi kwetimo letitsite, kuyintfo lephatselene nemaciniso ebuchwephesha,” v. 1554 (Inkantolo Yembuso, 1996). Lapha, lelicembu likholelwa kutsi inkantolo yesigodzi seyitsatse ngendlela lefanele lendzaba lechazwe lapha, futsi sincumo sayo sisekelwe ebufakazini bebungcweti. INkantolo Yesigodzi yatsi tati taPar betikholisa kakhulu kunetingcweti taHospira, ikakhulukati ngendlela yekutsi yetsembele “emaciniso ebuchwepheshe, kubaluleka kwenjongo yekuvimbela, kanye nekungagcini kwalomkhawulo.” Ngalokwehlukile, inkantolo yesigodzi yatsi tati taHospira “atizange tihlatiye ngendlela lenengcondvo imvelaphi yebuchwephesha nobe umsebenti wale- tonicity modifier leshiwo.” Ngekusebentisa lamaciniso, licembu letingcweti alizange litfole emaphutsa labonakalako.
Mayelana nemikhawulo yema-ejenti lahlanganisa tinsimbi tekugucuka, i-Federal Circuit yalahla inkhulumomphikiswano yaHospira yekutsi inkantolo yesigodzi bekufanele kutsi igcile kufomula yayo lephakanyisiwe jikelele kunetinhlinzeko letiku-ANDA yayo. LePhaneli itfola kutsi iNkantolo Yesigodzi itsatse kahle i-citric acid njengentfo leyinkimbinkimbi yensimbi yekugucuka lechazwe kuletimangalo, lokuhambisana nebufakazi bebungcweti babo bobabili labatsintsekako. Kususelwa ebufakazini bekutsi i-citric acid empeleni isebenta njengentfo lekhicitako, lombono uyayilahla inkhulumomphikiswano yaHospira yekutsi i-citric acid ayihloselwe kusetjentiswa njengentfo lekhicitako. Ngekuya kwe-35 USC§271(e)(2), lizinga lekugweba kwephulwa kwemtsetfo emacaleni e-ANDA ngulokucuketfwe lokuchazwe ku-ANDA (njengobe inkantolo ivetile, kwephulwa kwemtsetfo lokwakhako), icaphuna iSunovion Pharm. , Inc. v. , INkantolo Yembuso, 2013). Kutsembela kwe Hospira ku ANDA yayo kulizinga le ICH Q3D, lelisekela sincumo senkantolo yesigodzi, lokungenani hhayi ngoba lokucaphuna kwangetwa ku ANDA ngemuva kwekutsi i FDA idzinge “lolunye lwati” kulendzawo. I-ANDA ayizange ithule ngaloludzaba. I-Federal Circuit yatfola kutsi inkantolo yesigodzi beyinebufakazi lobenele bekufakazela kutsi sitatimende saHospira besihambisana ngalokuphelele nalomkhawulo.
Ekugcineni, mayelana ne pH-lenemtselela we citric acid kanye ne buffers yayo, iFederal Circuit lesekelwe esimangalweni sa Hospira futsi ayizange ibeke lilungelo lekufaka sicelo kuloludzaba. Ngetulu kwaloko, i- Federal Circuit yatfola kutsi lelicembu belitsi tintfo (letifanako) letichazwe ngemalungelo ekwakha e- ’876 na- ’657 “okungenani tikhombisa ngalokucinile lokuphambene.” Njengobe iNkantolo yeMbuso ingazange iphikisane nalesimangalo (noma nguyiphi lenye indzawo), iNkantolo yeMbuso yatsi iNkantolo yeSigodzi ayizange ifike esiphetfweni lesisobala sekutsi kwakheka kwaHospira kwephule simangalo lesichaziwe (emkhatsini waletinye tintfo, loku) Kuya ngekucuketfwe ngummango wenkantolo). Tincazelo) futsi kucinisekiswe.
(Inkantolo Yesifundza Yembuso 2020) Iphaneli: Imibono Yelijaji Lesifundza Dyk, Taranto naStoll, Lijaji Lesifundza Taranto
Disclaimer: Ngenca yesimo lesijwayelekile salesibuyeketo, lwati loluniketwe lapha lungase lungasebenti kuto tonkhe timo, futsi kute sinyatselo lokufanele sitsatfwe ngalolwati ngaphandle kweseluleko lesitsite semtsetfo lesisekelwe etimeni letitsite.
©McDonnell Boehnen Hulbert & Berghoff LLP namuhla = Lusuku lolusha (); var yyyy = namuhla.tfolaUmnyakaLogcwele (); idokhumenti.bhala (umnyaka + “”); | Tikhangiso Temmeli
Lewebhusayithi isebentisa emakhukhisi kwenta ncono indlela umsebentisi lasebentisa ngayo, kulandzelela kusetjentiswa kwemasayithi langatiwa, kugcina emathokheni ekugunyata kanye nekuvumela kwabelana kumanethiwekhi etinsita tekuchumana. Nawuchubeka uphenya le- website, usuke wemukela kusetjentiswa kwema- cookies. Chafata lapha kute utfole kabanti ngendlela lesiwasebentisa ngayo emakhukhisi.
Lilungelo lekushicilela © var namuhla = Lusuku lolusha (); var yyyy = namuhla.tfolaUmnyakaLogcwele (); idokhumenti.bhala (umnyaka + “”); JD Lesetulu, LLC