Isikhathi eside, abantu bebakholelwa bona isakhiwo seenkolodo singadlala indima eqakathekileko emacaleni welungelo lobunikazi. Ukukhuluma iqiniso lokhu kusisekelo se-Federal Circuit ukuqinisekisa isiqunto senkantolo yesifunda malungana nomkhiqizi wemithi ejwayelekileko esahlulelweni sakamuva se-District Pharmacopoeia ecaleni le-Par Pharmaceutical, Inc. v. Hospira, Inc. Ukwephulwa kwefomula ka-Par enelungelo lobunikazi, amazinga wephutha elicacileko nawo abe nomthelela emiphumeleni.
Imiraro le yabangelwa licala le-ANDA, lapho ummangali afuna khona i-Hospira's US Patent No. 9,119,876 kanye ne-9,925,657 malungana ne-Par's Adrenalin® (i-adrenaline) nendlela yokuphatha (ukujova). I-Hospira yakhuthaza ukungaphuli umthetho nokungasebenzi njengendlela yokuzivikela (ikhotho yesiyingi yafaka ukuzivikela ngokumelene ne-Hospira begodu ngalokho azange idlulisele isikhalazo). Ilungelo lobunikazi le-Par lihloselwe ukwakheka okunqoba ukutlhayela kwezakhiwo ze-adrenaline zangaphambilini. Ngebanga leendlela ezintathu ezihlukileko zokuwohloka (ukukhiqizwa kwe-oksijini, ukukhiqizwa kwe-racemisation kanye nokukhiqizwa kwe-sulfonation), ipilo yayo etjhelfini imfitjhani. Isimangalo 1 selungelo lobunikazi le-'876 simele:
Ukwakheka okuhlanganisa: pheze 0.5 ukuya ku-1.5 mg/mL ye-epinephrine kanye/nofana itswayi layo, pheze 6 ukuya ku-8 mg/mL yomlawuli we-tonicity, pheze 2.8 ukuya ku-3.8 mg/mL ye-ejenti yokukhuphula i-pH, kanye ne-antioxidant engaba ngu-0.1 ukuya ku-1.1 mg/mL, i-ejenti yehlisa i-pH ukuya ku-10.000. mL/mL kanye ne-0.01 ukuya ku-0.4 mg/mL mL ye-ejenti yokutjhuguluka kwensimbi, lapho i-antioxidant ifaka hlangana i-sodium bisulfite kanye/nofana i-sodium metabisulfite.
(Sebenzisa amagama aqinileko embonweni ukutjengisa imikhawulo ehlobene nesikhalazo saka-Hospira). Ngemva kokuhlathulula imikhawulo le, umbono wahlongoza ihlathululo yegama elithi "isivumelwano" esisetjenziswa yikhotho yesiyingi emkhawulweni ngamunye. Amaqembu avumelana ngokukhanyako bona ibizo kufanele libe nencazelo yalo ejayelekileko, okungukuthi "mayelana"; ngeKhotho yokuDlulisa amacala ye-Federal Circuit, i-Hospira azange inikeze ihlathululo ephikisanako.
Bobabili abathintekako banikela ubufakazi bobungcweti ngeenqabo ezintathu ezingenhla. Iingcwethi zika-Parr zafakaza bona ikhotho isebenzise i-9 mg/mL ye-sodium chloride ukuthola ukwephulwa okuphakathi kwe-6 ukuya ku-8 mg/mL (ukugxila kwe-Hospira, nanyana ukugxila okuphasi njenge-8.55 mg/mL nakho kusetjenziswa) ngombana kwanele ukuhlangabezana nomnqopho ohlosiweko, okungukuthi “ukugcina ubuqotho bamaseli ngaphakathi emgqeni iingazi." Iingcwethi ze-Hospira zaphakamisa ukuphikisana kwabasebenzisani bakhe ngokuthi ingabe abososayensi bakhe abanekhono bakholelwa bona i-9 mg/mL iwela ngaphakathi kwebanga “elilinganiselwa” ku-6-8 mg/mL.
Malungana nokulinganiselwa kweenhlanganisela zensimbi ezitjhugulukako, ikhotho yesiyingi ifakazele bona i-citric acid yi-ejenti eyaziwako ye-chelating ngokuya ngobufakazi. I-Hospira yatjho ku-ANDA yayo bona okuqukethwe kwezinto ezingcolileko (iinsimbi) kungaphakathi kwamazinga weentjhabatjhaba (khulukhulu i-ICH Q3D) Imihlahlandlela). Iingcwethi ze-Par zifakazele bona ubudlelwano obufanako hlangana nomkhiqizo ojwayelekileko kanye nokugxila kwe-ejenti ye-chelating yensimbi etjhiwo eenkolodweni kungaphakathi kwebanga elitlhogekako. Iingcwethi ze-Hospira godu azange ziphalisane neengcwethi ze-Par ngokubanzi, kodwana kwafakazela bona umkhawulo ophezulu wezinga le-ICH Q3D bewulizinga elingakafaneli lekhotho yesiyingi. Esikhundleni salokho, ukholelwa bona inani elifaneleko kufanele likhishwe esiqhemeni sokuhlolwa se-Hospira, akholelwa bona sizokutlhoga amazinga aphasi khulu we-citric acid njenge-ejenti ye-chelating.
Amaqembu amabili la ancintisana ngokusebenzisa isisetjenziswa esehlisa i-pH i-Hospira's ANDA ukucacisa ukugxila kwe-citric acid njenge-buffer (ne-sodium citrate yayo). Emkhakheni, i-citric acid ngokwayo ithathwa njengokukhuphula i-pH (begodu akungabazeki bona i-citric acid ngokwayo yi-ejenti yokwehlisa i-pH). Ngokuya kweengcwethi ze-Par, ukususa inani le-citric acid kufomula ye-Hospira kwanele ukwenza i-citric acid iwe ngaphakathi kwebanga le-ejenti yokwehlisa i-pH ebizwa ngu-Par. "Ngitjho namamolekhyuli we-citric acid afanako azokuba yingcenye yesistimu ye-buffer (i-citric acid ehlanganisiweko ne-sodium citrate kusetjenziswa ndawonye njenge-ejenti yokukhuphula i-pH." (Nanyana kunokuphikisana okusobala, khumbula bona ukwephulwa komthetho kuyindaba yamaqiniso. I-Federal Circuit izakubuyekeza isiqunto sekhotho yesiyingi ecaleni ukufikelela emaphutheni abonakalako.) iingcwethi azivumelani neengcwethi zika-Par begodu zifakazele (ngokuzwakalako) bona amamolekhyuli we-citric acid ekubunjweni akukafaneli athathwe njengawo womabili aphasisa i-pH begodu akhuphule i-pH Nanyana kunjalo, ikhotho yesiyingi yaqunta bona u-Par wanqoba icala begodu isiphakamiso saka-Hospira sizokwephula amalungelo welungelo lobunikazi laka-Par.
IJaji u-Taranto bekakholelwa bona i-Federal Circuit ivumile bona i-Judge Dyke no-Judge Stoll nabo bebakhona emhlanganweni. Isikhalazo saka-Hospira besibandakanya isiqunto senkantolo yesiyingi kiyo yoke imikhawulo emithathu. I-Federal Circuit yathoma ukuqinisekisa okutholwe yiKhotho yesiFunda ngombono wayo wokuthi ukugxila kwe-9 mg/mL ye-sodium chloride ku-Hospira formulation kwawela ngaphakathi komkhawulo “olinganiselwa” we-6-8 mg/mL ofunwa yi-Par. Isiqhema seengcwethi siveze bona lokha nawusebenzisa ibizo elithi "cishe", "balekela ukusebenzisa imingcele eqinileko yeenomboro kumapharamitha athileko," kuveza i-Cohesive Techs. v. Water Corp., 543 F. 3d 1351 (Fed. Cir. 2008), ngokusekelwe ku-Pall Corp. v. Micron Separations, Inc., 66 F. 3d 1211, 1217 (Fed. Cir. 1995). Ukudzubhula isitatimende se-Monsanto Tech, lokha “mayelana” nakutjhugululwa eenkolodweni, ibanga leenomboro elifunwako linganwetshwa ngaphezu kwebanga ukufikela lapho umuntu onekghono “azokucabangela ngokuzwakalako” ububanzi obuhlanganiswe simangalo. LLC v. EI DuPont de Nemours & Co., 878 F.3d 1336, 1342 (iKhotho ye-Federal 2018). Ebujameni obunjalo, nangabe akukho hlangothi elikhuthaza ukwehlisa ububanzi besimangalo, ukuzimisela kusekelwe ezingeni lokubumbana. Iinhloko zezinga leli zifaka hlangana bona ifomula yokuphula umthetho "ilinganiselwe" ukusuka emkhakheni wokuvikeleka (Conopco, Inc. v. May Dep't Stores Co., 46 F.3d 1556, 1562 (Federal Court, 1994). )) , Nokuthi ububanzi bokuvikeleka buqakatheke kangangani ngehloso yokuziveza ( ). Nanyana ivuma bona isimangalo sifaka isandla esiquntwini senkantolo malungana nendaba le, i-Federal Circuit yaveza: “Ukuthi idivayisi yommangalelwa ihlangabezana na nesivumelwano esizwakalako ngaphasi kobujamo obuthileko kuyindaba yamaqiniso wezobuchwepheshe,” v. US Int'l Trade Comm', 75 Federal 355, 1455, 1545 (Federal Court, 1996). Lapha, iphaneli ikholelwa bona ikhotho yesifunda yamukele kuhle isibonelo esichazwe lapha, begodu isiqunto sayo sisekelwe ebufakazini bochwepheshe. Ikhotho yesiFunda yathi izazi zika-Par bezikholisa ukudlula izazi ze-Hospira, khulukhulu ngezinga lokobana ithembele "emaqinisweni wezobuchwepheshe, ukuqakatheka kwehloso yokuvinjelwa, nokungaqakatheki kokuvinjelwa." Ngokuphikisako, ikhotho yesiyingi yathi izazi ze-Hospira "azange zenze ukuhlaziywa okuzwakalako kwesizinda sezobuchwepheshe nofana umsebenzi we-tonicity modifier." Ngokuya ngamaqiniso la, iphaneli yeengcwethi ayitholanga amaphutha abonakalako.
Malungana nokulinganiselwa kwama-ejenti we-transition metal complexing, i-Federal Circuit yalahla ipikiswano ka-Hospira yokuthi ikhotho yesiyingi bekufanele bona igxile efomula yayo ejwayelekileko kunokobana itjheje imibandela ese-ANDA yayo. Iphaneli ithola bona iKhotho yesiFunda ithathe kuhle i-citric acid njenge-ejenti yokutjhuguluka kwensimbi echazwe eenmangalweni, okuhambisana nobufakazi bochwepheshe bamaqembu womabili. Ngokuya ngobufakazi bokuthi i-citric acid isebenza njenge-chelating ejenti, umbono lo uyalahla ipikiswano ka-Hospira yokuthi i-citric acid ayihloselwe ukusetjenziswa njenge-chelating ejenti. Ngokuya kwe-35 USC§271(e)(2), izinga lokuqunta ukwephulwa komthetho emacaleni we-ANDA ngilokho okuchazwe ku-ANDA (njengombana ikhotho iveze, kuphulwa komthetho okwakhako), ngokuveza i-Sunovion Pharm. , Inc. v. Teva Pharm. , USA, Inc., 731 F.3d 1271, 1279 (Federal Court, 2013). Ukuthembela kwe-Hospira ku-ANDA yayo lizinga le-ICH Q3D, elisekela isiqunto senkantolo yesiyingi, okungenani ingasi ngombana ukucaphuna lokhu kwafakwa ku-ANDA ngemva kokuthi i-FDA ifune “elinye ilwazi” endaweni le. I-ANDA azange ithule ngendaba le. I-Federal Circuit ithole bona ikhotho yesiyingi inobufakazi obaneleko bokufakazela bona isitatimende saka-Hospira sithobela ngokupheleleko ukuvinjelwa.
Ekugcineni, malungana nezakhiwo ezithonya i-pH ze-citric acid kanye namabhafa wayo, i-Federal Circuit isekelwe esibaweni saka-Hospira begodu azange ibeke ilungelo lokufaka isibawo ngale ndaba. Ukungezelela, i-Federal Circuit ifunde bona iphaneli ithi (okufanako) ukucaciswa kwamalungelo wobunikazi we-'876 no-'657 "okungenani kutjengisa okuphambene." Njengombana iKhotho ye-Federal ingazange iphikise isimangalo lesi (namkha enye indawo), iKhotho ye-Federal yathi iKhotho yesiFunda ayizange ifinyelele esiphethweni esibonakalako sokuthi ukwakheka kwe-Hospira kwephule isimangalo esichaziweko (hlangana nezinye izinto, lokhu) Kuya ngokuqukethwe komphakathi kwekhotho). Iinqophiso) begodu ziqinisekiswe.
I-Par Pharmaceutical, Inc. v. Hospira, Inc. (Ikhotho ye-Federal Circuit 2020) Iphaneli: Imibono kaMahluleli we-Circuit u-Dyk, u-Taranto no-Stoll, i-Circuit Judge u-Taranto
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