Kangangexesha elide, abantu bebekholelwa ukuba ulwakhiwo lwamabango lunokudlala indima ebalulekileyo kwaye ludla ngokudlala indima ebalulekileyo kwityala lelungelo lomenzi. Olu thetha phandle lusisiseko sokuba iFederal Circuit iqinisekise isigqibo senkundla yesithili ngokuchasene nomenzi wamayeza aqhelekileyo kwisigwebo samva nje seDistrict Pharmacopoeia kwityala lePar Pharmaceutical, Inc. v. Hospira, Inc.. Ukwaphulwa kwefomyula yelungelo lomenzi kaPar, imigangatho yempazamo ecacileyo nayo ibe nefuthe kwiziphumo.
Ezi ngxaki zabangelwa kwityala le-ANDA, apho ummangali wabanga iiNombolo zePatent zase-US zeHospira 9,119,876 kunye ne-9,925,657 malunga nePar's Adrenalin® (adrenaline) kunye nendlela yayo yokusetyenziswa (injection). IHospira yayikhuthaza ukungaphulwa komthetho kunye nokungasebenzi njengezokhuselo (inkundla yesithili yafaka isikhuselo nxamnye neHospira kwaye ngenxa yoko ayizange ibhenele). Ipatent yePar ijoliswe kwifomyula eyoyisa ukusilela kwefomyula zangaphambili ze-adrenaline. Ngenxa yeendlela ezintathu ezahlukeneyo zokuwohloka (i-oxidation, i-racemization kunye ne-sulfonation), ubomi bayo beshelufu bufutshane kakhulu. Ibango 1 lepatent ka-'876 limele:
Umxube oquka: malunga ne-0.5 ukuya kwi-1.5 mg/mL ye-epinephrine kunye/okanye ityuwa yayo, malunga ne-6 ukuya kwi-8 mg/mL ye-tonicity regulator, malunga ne-2.8 ukuya kwi-3.8 mg/mL ye-pH raising agent, kunye ne-antioxidant emalunga ne-0.1 ukuya kwi-1.1 mg/mL, i-pH lowering agent engu-0.001 ukuya kwi-0.010 mL/mL kunye malunga ne-0.01 ukuya kwi-0.4 mg/mL ye-transition metal complexing agent, apho i-antioxidant iquka i-sodium bisulfite kunye/okanye i-sodium metabisulfite.
(Sebenzisa umbhalo ongqindilili kwimbono yakho ukubonisa imiqathango enxulumene nesibheno sikaHospira). Emva kokuchaza le miqathango, uluvo lucebise ukutolikwa kwegama elithi “umnqophiso” elisetyenziswa yinkundla yesithili kwisithintelo ngasinye. Amaqela avumile ngokucacileyo ukuba eli gama kufuneka libe nentsingiselo yalo eqhelekileyo, ethi “malunga”; kwiNkundla yeziBheno yeSithili seSizwe, uHospira akazange anike ngcaciso echasene noko.
Omabini la maqela anike ubungqina beengcali kule miqathango mithathu ingasentla. Iingcali zikaParr zingqine ukuba inkundla isebenzise i-9 mg/mL yesodium chloride ukufumanisa ukwaphulwa komthetho kuluhlu lwe-6-8 mg/mL (uxinzelelo lweHospira, nangona uxinano oluphantsi njenge-8.55 mg/mL lukwasetyenziswa) kuba kwanele ukuhlangabezana nenjongo ebekiweyo, eyokugcina "ukuthembeka kweeseli eziphilayo emva kokufaka i-adrenaline egazini." Iingcali zikaHospira ziphakamise kuphela izikhalazo kubalingane bakhe malunga nokuba iingcali zakhe ezinobuchule zikholelwa na ukuba i-9 mg/mL iwela ngaphakathi koluhlu "olumalunga" ne-6-8 mg/mL.
Ngokuphathelele imida yee-transition metal complexes, inkundla yesithili ibonakalise ukuba i-citric acid yiarhente ye-chelating eyaziwayo ngokusekelwe kubungqina. I-Hospira itshilo kwi-ANDA yayo ukuba umxholo wokungcola kwezinto ezisisiseko (iimetali) ungaphakathi kwemigangatho yamazwe ngamazwe (ngakumbi izikhokelo ze-ICH Q3D). Iingcali zikaPar zibonakalise ukuba ubudlelwane obuhambelanayo phakathi kwemveliso esemgangathweni kunye noxinzelelo lwearhente ye-chelating yesinyithi echazwe kumabango bungaphakathi koluhlu olufunekayo. Iingcali zikaHospira azizange zikhuphisane neengcali zikaPar ngokubanzi, kodwa zibonakalise ukuba umda ophezulu womgangatho we-ICH Q3D wawungumgangatho ongafanelekanga kwinkundla yesithili. Endaweni yoko, ukholelwa ukuba isixa esifanelekileyo kufuneka sikhutshwe kwi-batch yovavanyo lukaHospira, akholelwa ukuba kuya kufuna amanqanaba aphantsi kakhulu e-citric acid njengearhente ye-chelating.
La maqela mabini akhuphisana ngokusebenzisa i-arhente yokwehlisa i-pH i-Hospira's ANDA ukucacisa uxinano lwe-citric acid njenge-buffer (kunye ne-sodium citrate yayo). Kwintsimi, i-citric acid ngokwayo ithathwa njengeyonyusa i-pH (kwaye akukho mathandabuzo ukuba i-citric acid ngokwayo yi-A pH yokunciphisa i-pH). Ngokutsho kweengcali zePar, ukuthabatha ubungakanani be-citric acid kwifomyula yeHospira kwanele ukwenza i-citric acid iwele ngaphakathi koluhlu lwe-arhente yokunciphisa i-pH ebangwe yiPar. “Kwanaloo molecules ye-citric acid efanayo iya kuba yinxalenye yenkqubo ye-buffer (i-Citric acid edibeneyo kunye ne-sodium citrate zisetyenziswa kunye njenge-arhente yokunyusa i-pH.” (Nangona kukho ukungqubana okucacileyo, khumbula ukuba ukwaphulwa komthetho yinto ekhoyo. I-Federal Circuit iya kuhlaziya isigqibo senkundla yesithili kwityala. Ukuze kufikelelwe kwimpazamo ecacileyo.) Iingcali zeHospira azivumelani neengcali zePar kwaye zibonakalise (ngokufanelekileyo) ukuba iimolekyuli ze-citric acid kwifomyula akufuneki zithathwe njengezokwehlisa i-pH kunye nezonyusa i-pH. Nangona kunjalo, inkundla yesithili yagqiba kwelokuba iPar iphumelele ityala kwaye isindululo seHospira siya kuphula amalungelo elungelo lomenzi wePar. Esi sibheno salandela.
UJaji uTaranto wayekholelwa ukuba iFederal Circuit iqinisekisile ukuba uJaji uDyke kunye noJaji uStoll nabo baye kwintlanganiso. Isibheno sikaHospira sasibandakanya isigqibo senkundla yesithili kwimiqathango emithathu nganye. IFederal Circuit yaqala yaqinisekisa iziphumo zeNkundla yeSithili ngoluvo lwayo lokuba uxinzelelo lwe-9 mg/mL sodium chloride kwifomyula yeHospira luwele ngaphakathi komda "omalunga" we-6-8 mg/mL ofunwa yiPar. Iqela leengcali libonise ukuba xa kusetyenziswa igama elithi "malunga", "thintela ukusebenzisa imida yamanani engqongqo kwiiparameter ezichaziweyo," kucaphula iCohesive Techs. v. Water Corp., 543 F. 3d 1351 (Fed. Cir. 2008), ngokusekelwe kwiPall Corp. v. Micron Separations, Inc., 66 F. 3d 1211, 1217 (Fed. Cir. 1995). Ukucaphula ingxelo yeMonsanto Tech, xa "malunga" itshintshiwe kwiibango, uluhlu lwamanani olubangwayo lunokwandiswa ngaphaya koluhlu ukuya kuthi ga kwinqanaba apho umntu onobuchule "uya kuqwalasela ngokufanelekileyo" umda ogutyungelwe yibango. LLC v. EI DuPont de Nemours & Co., 878 F.3d 1336, 1342 (Federal Court 2018). Kwiimeko ezinjalo, ukuba akukho qela lixhasa ukunciphisa umda webango, isigqibo sisekelwe kumgangatho wobumbano. Izinto zalo mgangatho ziquka ukuba ifomula etyholwayo yokwaphulwa komthetho "iphakathi" na kububanzi bokhuseleko (Conopco, Inc. v. May Dep't Stores Co., 46 F.3d 1556, 1562 (Federal Court, 1994). )) , Kwaye kubaluleke kangakanani umda wokhuseleko ngenjongo yokukhawulela (hayi olu vumbululo lwangoku) ngokwalo. Nangona ivuma ukuba ibango linegalelo kwisigqibo senkundla ngalo mba, iFederal Circuit yathi: “Ukuba isixhobo sommangalelwa siyahlangabezana nentsingiselo “yomnqophiso” efanelekileyo phantsi kweemeko ezithile ngumbandela weenkcukacha zobugcisa,” v. US Int'l Trade Comm', 75 F.3d 1545, 1554 (Federal Court, 1996). Apha, iphaneli ikholelwa ukuba inkundla yesithili iyamkele ngokufanelekileyo umzekelo ochazwe apha, kwaye isigqibo sayo sisekelwe kubungqina beengcali. INkundla yeSithili yagqiba kwelokuba iingcali zePar zazikholisa ngakumbi kuneengcali zeHospira, ngakumbi kangangokuba yayixhomekeke “kwiinyani zobugcisa, ukubaluleka kwenjongo yothintelo, kunye nokungagxekwa kothintelo.” Ngokwahlukileyo koko, inkundla yesithili yagqiba kwelokuba iingcali zeHospira “azizange zenze uhlalutyo olunentsingiselo lwemvelaphi yobugcisa okanye umsebenzi womguquli wetonicity obangwayo.” Ngokusekelwe kwezi nyaniso, iphaneli yeengcali ayizange ifumane zimpazamo zicacileyo.
Ngokuphathelele imida yee-arhente ze-transition metal complexing, i-Federal Circuit yala ingxoxo kaHospira yokuba inkundla yesithili bekufanele ukuba igxile kwifomyula yayo ngokubanzi ecetywayo endaweni yemigaqo ekwi-ANDA yayo. Iphaneli ifumanisa ukuba iNkundla yeSithili yayijonga ngokuchanekileyo i-citric acid njenge-arhente ye-transition metal complexing echazwe kumabango, nto leyo ehambelana nobungqina beengcali zamaqela omabini. Ngokusekelwe kubungqina bokuba i-citric acid isebenza njenge-arhente ye-chelating, olu luvo luyala ingxoxo kaHospira yokuba i-citric acid ayijoliswanga ukusetyenziswa njenge-arhente ye-chelating. Ngokutsho kwe-35 USC§271(e)(2), umgangatho wokugweba ukwaphulwa kwemithetho kwityala le-ANDA ngumxholo ochazwe kwi-ANDA (njengoko inkundla ibonisile, kukwaphulwa kwemithetho okwakhayo), icaphula iSunovion Pharm., Inc. v. Teva Pharm., USA, Inc., 731 F.3d 1271, 1279 (Federal Court, 2013). Ukuthembela kweHospira kwi-ANDA yayo ngumgangatho we-ICH Q3D, oxhasa isigqibo senkundla yesithili, ubuncinane kungengenxa yokuba olu xwebhu longezwe kwi-ANDA emva kokuba i-FDA ifune "ulwazi olulolunye" kule ndawo. I-ANDA ayizange ithule kule ngxaki. I-Federal Circuit ifumanise ukuba inkundla yesithili inobungqina obaneleyo bokungqina ukuba ingxelo yeHospira iyahambelana ngokupheleleyo nomda.
Okokugqibela, malunga neepropati ezinefuthe le-pH ze-citric acid kunye nee-buffers zayo, i-Federal Circuit isekelwe kwibango likaHospira kwaye ayizange igcine ilungelo lokufaka ibango kulo mba. Ukongeza, i-Federal Circuit ifunde ukuba iphaneli igqibe kwelokuba iinkcukacha (ezifanayo) zeepatenti zika-'876 kunye no-'657 "ubuncinane zibonisa okuchaseneyo." Ekubeni iNkundla yeFederal ingazange iyichase le bango (okanye nakweyiphi na enye indawo), iNkundla yeFederal yagqiba kwelokuba iNkundla yeSithili ayizange ifikelele kwisigqibo esicacileyo sokuba indlela kaHospira eyaphula ngayo ibango elichaziweyo (phakathi kwezinye izinto, oku) Kuxhomekeke kumxholo woluntu wenkundla). Iinkcukacha) kwaye ziqinisekiswe.
Iphaneli yePar Pharmaceutical, Inc. v. Hospira, Inc. (iNkundla yeSekethe yeFederal 2020): Izimvo zoMgwebi weSekethe uDyk, uTaranto kunye noStoll, uMgwebi weSekethe uTaranto
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