Sekuyisikhathi eside, abantu bebekholelwa ukuthi isakhiwo sezimangalo singadlala indima ebalulekile futhi ngokuvamile sidlala indima ebalulekile enkantolo yelungelo lobunikazi. Lokhu kwethembeka kuyisisekelo se-Federal Circuit sokuqinisekisa isinqumo senkantolo yesifunda ngokumelene nomkhiqizi wemithi ejwayelekile esahlulelweni sakamuva se-District Pharmacopoeia ecaleni le-Par Pharmaceutical, Inc. v. Hospira, Inc.. Ukwephulwa kwefomula yelungelo lobunikazi likaPar, amazinga amaphutha acacile nawo abe nomthelela emiphumeleni.
Lezi zinkinga zabangelwa ecaleni le-ANDA, lapho ummangali afuna khona ama-US Patent No. 9,119,876 kanye nama-9,925,657 e-Hospira's Adrenalin® (adrenaline) kanye nendlela yokuphatha (umjovo). I-Hospira ikhuthaza ukungaphulwa kwemithetho kanye nokungasebenzi njengezivikelo (inkantolo yesifunda yafaka isivikelo ngokumelene ne-Hospira ngakho-ke ayizange idlulise isikhalo). I-Par patent ihloselwe ukwakheka okunqoba ukushiyeka kwezakhi zokwenziwa ze-adrenaline zangaphambilini. Ngenxa yezindlela ezintathu ezahlukene zokuwohloka (i-oxidation, i-racemization kanye ne-sulfonation), isikhathi sayo sokuhlala isikhathi eside sifushane kakhulu. Isimangalo 1 se-'876 patent simelela:
Ukwakheka okuhlanganisa: cishe u-0.5 kuya ku-1.5 mg/mL we-epinephrine kanye/noma usawoti wayo, cishe u-6 kuya ku-8 mg/mL we-tonicity regulator, cishe u-2.8 kuya ku-3.8 mg/mL we-pH raising agent, kanye ne-antioxidant engaba ngu-0.1 kuya ku-1.1 mg/mL, i-pH lowehlisayo engu-0.001 kuya ku-0.010 mL/mL kanye no-0.01 kuya ku-0.4 mg/mL we-transition metal complexing agent, lapho i-antioxidant ihlanganisa i-sodium bisulfite kanye/noma i-sodium metabisulfite.
(Sebenzisa umbhalo ogqamile embonweni ukuze ubonise imikhawulo ehlobene nesikhalazo sikaHospira). Ngemva kokuchaza le mikhawulo, umbono uphakamise ukuchazwa kwegama elithi “isivumelwano” elisetshenziswa yinkantolo yesifunda kumkhawulo ngamunye. Izinhlangothi zivumile ngokusobala ukuthi leli gama kufanele libe nencazelo yalo evamile, ethi “mayelana”; eNkantolo Yokudlulisa Amacala Kahulumeni Yesifunda, uHospira akazange anikeze incazelo ephikisana nalokho.
Womabili amaqembu anikeze ubufakazi bochwepheshe ngale mikhawulo emithathu engenhla. Ochwepheshe bakaParr bafakaze ukuthi inkantolo isebenzise i-9 mg/mL sodium chloride ukunquma ukwephulwa kobubanzi obungu-6-8 mg/mL (i-Hospira concentration, yize amazinga aphansi njengo-8.55 mg/mL nawo asetshenziswa) ngoba kwanele ukufeza injongo ehlosiwe, okuwukugcina ubuqotho bamangqamuzana aphilayo ngemva kokufaka i-adrenaline egazini.” Ochwepheshe bakaHospira baphakamise kuphela ukuphikisana kozakwabo ngokuthi ochwepheshe bakhe abanekhono babekholelwa yini ukuthi i-9 mg/mL iwela ngaphakathi kobubanzi "obucishe bube" ngu-6-8 mg/mL.
Ngokuphathelene nemikhawulo yezakhiwo zensimbi ezishintshayo, inkantolo yesifunda ifakazele ukuthi i-citric acid iyi-ejenti ye-chelating eyaziwayo ngokusekelwe ebufakazini. I-Hospira isho ku-ANDA yayo ukuthi okuqukethwe kokungcola kwezinto eziyisisekelo (izinsimbi) kungaphakathi kwezindinganiso zomhlaba wonke (ikakhulukazi i-ICH Q3D) Guidelines). Ochwepheshe bakaPar bafakazele ukuthi ubudlelwano obuhambisanayo phakathi komkhiqizo ojwayelekile kanye nokuhlushwa kwe-ejenti ye-chelating yensimbi okukhulunywe ngakho ezimangalweni bungaphakathi kobubanzi obudingekayo. Ochwepheshe bakaHospira baphinde abaphikisananga nochwepheshe bakaPar ngokujwayelekile, kodwa kwafakazela ukuthi umkhawulo ophezulu wendinganiso ye-ICH Q3D wawuyindinganiso engafanele enkantolo yesifunda. Esikhundleni salokho, ukholelwa ukuthi inani elifanele kufanele likhishwe eqenjini lokuhlola likaHospira, akholelwa ukuthi lizodinga amazinga aphansi kakhulu e-citric acid njenge-ejenti ye-chelating.
La maqembu amabili ancintisana ngokusebenzisa i-Hospira's ANDA yokwehlisa i-pH ukuze kuchazwe ukuhlushwa kwe-citric acid njenge-buffer (kanye ne-sodium citrate yayo). Ensimini, i-citric acid ngokwayo ibhekwa njengenyusa i-pH (futhi akungabazeki ukuthi i-citric acid ngokwayo iyi-A pH yokwehlisa i-pH). Ngokusho kochwepheshe bePar, ukususa inani le-citric acid kufomula yeHospira kwanele ukwenza i-citric acid iwele ngaphakathi kobubanzi be-pH agent ehlisa i-pH eshiwo yiPar. “Ngisho nalawo ma-molecule afanayo e-citric acid azoba yingxenye yesistimu ye-buffer (i-Citric acid ehlanganisiwe kanye ne-sodium citrate kusetshenziswa ndawonye njenge-ejenti yokuphakamisa i-pH.” (Nakuba kukhona ukuphikisana okusobala, khumbula ukuthi ukwephulwa kwemithetho kuyindaba yeqiniso. I-Federal Circuit izobuyekeza isinqumo senkantolo yesifunda esiqinisweni. Ukuze kufinyelelwe ephutheni elisobala.) Ochwepheshe be-Hospira abavumelani nochwepheshe be-Par futhi bafakazele (ngokufanele) ukuthi ama-molecule e-citric acid ekwakhiweni akufanele abhekwe njengokwehlisa i-pH kanye nokwandisa i-pH. Kodwa-ke, inkantolo yesifunda yanquma ukuthi i-Par iwine icala futhi isiphakamiso se-Hospira sizophula amalungelo elungelo lobunikazi le-Par. Lesi sikhalazo salandela.
IJaji uTaranto likholelwa ukuthi iSifundazwe Sikahulumeni siqinisekisile ukuthi iJaji uDyke kanye neJaji uStoll nabo babekhona emhlanganweni. Isikhalazo sikaHospira sihilele isinqumo senkantolo yesifunda kulowo nalowo mkhawulo emithathu. ISifundazwe Sikahulumeni siqale saqinisekisa okutholakele eNkantolo Yesifunda ngombono waso wokuthi ukuhlushwa kwe-9 mg/mL sodium chloride ekwakhiweni kweHospira empeleni kuwele ngaphakathi komkhawulo "ocishe ube" ngu-6-8 mg/mL ofunwa yiPar. Iqembu lochwepheshe likhombe ukuthi uma usebenzisa igama elithi "cishe", "gwema ukusebenzisa imingcele yezinombolo eqinile kumapharamitha acacisiwe," kusho iCohesive Techs. v. Water Corp., 543 F. 3d 1351 (Fed. Cir. 2008), ngokusekelwe kuPall Corp. v. Micron Separations, Inc., 66 F. 3d 1211, 1217 (Fed. Cir. 1995). Uma sicaphuna isitatimende seMonsanto Tech, uma "mayelana" kuguqulwa ezimangalweni, ububanzi bezinombolo obufunwayo bungandiswa ngale kobubanzi kuze kube yilapho umuntu onekhono "ezocabangela ngokufanele" ububanzi obumbozwe yisicelo. LLC v. EI DuPont de Nemours & Co., 878 F.3d 1336, 1342 (Federal Court 2018). Ezimweni ezinjalo, uma kungekho muntu osekela ukunciphisa ububanzi besimangalo, isinqumo sisekelwe endinganisweni yobumbano. Izici zalesi simiso zifaka phakathi ukuthi ifomula yokwephulwa okusolwayo "iphakathi nendawo" kusukela kububanzi bokuvikelwa (Conopco, Inc. v. May Dep't Stores Co., 46 F.3d 1556, 1562 (Federal Court, 1994). )) , Futhi ubukhulu bokuvikelwa bubaluleke kangakanani ngenhloso yokukhawulela (hhayi lokhu okusunguliwe) uqobo. Nakuba ivuma ukuthi isimangalo siyingxenye yesinqumo senkantolo ngalolu daba, i-Federal Circuit yaveza ukuthi: “Ukuthi ngabe icebo lommangalelwa liyahlangabezana yini nencazelo “yesivumelwano” enengqondo ngaphansi kwezimo ezithile kuyindaba yamaqiniso obuchwepheshe,” v. US Int'l Trade Comm', 75 F.3d 1545, 1554 (Federal Court, 1996). Lapha, iphaneli ikholelwa ukuthi inkantolo yesifunda isamukele ngokufanele isibonelo esichazwe lapha, futhi isinqumo sayo sisekelwe ebufakazini bochwepheshe. INkantolo Yesifunda yanquma ukuthi ochwepheshe bePar babekholisa kakhulu kunochwepheshe beHospira, ikakhulukazi ngezinga lokuthi ithembele “emaqinisweni obuchwepheshe, ukubaluleka kwenhloso yokuvinjelwa, kanye nokungagxekwa kokuvinjelwa.” Ngokuphambene nalokho, inkantolo yesifunda yanquma ukuthi ochwepheshe beHospira “abenzanga ukuhlaziywa okunengqondo kwesizinda sobuchwepheshe noma umsebenzi womuguquli we-tonicity ofunwayo.” Ngokusekelwe kula maqiniso, iphaneli yochwepheshe ayitholanga amaphutha asobala.
Ngokuphathelene nemikhawulo yama-ejenti okuguqula insimbi, i-Federal Circuit yenqabe impikiswano kaHospira yokuthi inkantolo yesifunda kwakufanele igxile kufomula yayo ejwayelekile ephakanyisiwe kunezinhlinzeko eziku-ANDA yayo. Iphaneli ithola ukuthi iNkantolo Yesifunda ibheke i-citric acid ngendlela efanele njenge-ejenti yokuguqula insimbi echazwe ezimangalweni, okuhambisana nobufakazi bochwepheshe bobabili izinhlangothi. Ngokusekelwe ebufakazini bokuthi i-citric acid empeleni isebenza njenge-ejenti yokuguqula, lo mbono wenqaba impikiswano kaHospira yokuthi i-citric acid ayihloselwe ukusetshenziswa njenge-ejenti yokuguqula. Ngokusho kwe-35 USC§271(e)(2), indinganiso yokwahlulela ukwephulwa kwecala enkantolo ye-ANDA okuqukethwe okuchazwe ku-ANDA (njengoba inkantolo ibonisile, kuwukwephulwa okwakhayo), icaphuna i-Sunovion Pharm., Inc. v. Teva Pharm., USA, Inc., 731 F.3d 1271, 1279 (Federal Court, 2013). Ukuthembela kweHospira ku-ANDA yayo kuyindinganiso ye-ICH Q3D, esekela isinqumo senkantolo yesifunda, okungenani hhayi ngoba lesi sihloko sengezwe ku-ANDA ngemuva kokuba i-FDA ifune “ulwazi oluhlukile” kule ndawo. I-ANDA ayizange ithule ngalolu daba. I-Federal Circuit ithole ukuthi inkantolo yesifunda yayinobufakazi obanele bokufakazela ukuthi isitatimende seHospira sihambisana ngokugcwele nomkhawulo.
Okokugcina, maqondana nezakhiwo ezithinta i-pH ze-citric acid kanye nama-buffer ayo, i-Federal Circuit isuselwe esimangalweni sikaHospira futhi ayizange igodle ilungelo lokufaka isimangalo ngalolu daba. Ngaphezu kwalokho, i-Federal Circuit ithole ukuthi iphaneli iphethe ngokuthi izincazelo (ezifanayo) zama-patents ka-'876 no-'657 "okungenani zibonisa okuphambene nalokho." Njengoba iNkantolo Yombuso ingazange iphikise lesi simangalo (noma enye indawo), iNkantolo Yombuso iphethe ngokuthi iNkantolo Yesifunda ayizange ifinyelele esiphethweni esicacile sokuthi ukwakheka kukaHospira kwephule isimangalo esichaziwe (phakathi kwezinye izinto, lokhu) Kuncike kokuqukethwe komphakathi kwenkantolo). Izincazelo) futhi kuqinisekiswe.
Iphaneli yePar Pharmaceutical, Inc. v. Hospira, Inc. (Federal Circuit Court 2020): Imibono yeJaji Lesifunda uDyk, uTaranto noStoll, iJaji Lesifunda uTaranto
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