Okumala ebbanga ddene, abantu babadde bakkiriza nti ensengeka y’okusaba esobola era emirundi mingi ekola kinene mu misango gya patent. Obwesimbu buno gwe musingi gwa Federal Circuit okukakasa ensala ya kkooti y’essaza ku kkampuni ekola eddagala erya generic mu nsala eyasembyeyo eya District Pharmacopoeia mu musango gwa Par Pharmaceutical, Inc. v. Hospira, Inc. Okumenya enkola ya Par eya patent, emitendera egy’ensobi egy’olwatu nagyo gyalina kye gyakola ku bivuddemu.
Ebizibu bino byava mu musango gwa ANDA, omuwawaabirwa mwe yasaba Hospira’s US Patent Nos. 9,119,876 ne 9,925,657 ku bikwata ku Par’s Adrenalin® (adrenaline) n’enkola yaayo ey’okugigaba (empiso). Hospira yawagira obutamenya mateeka n’obutabeera na makulu ng’okwewozaako (kkooti y’essaza yawaaba omusango ku Hospira n’olwekyo teyajulira). Patent ya Par egendereddwamu enkola evvuunuka obusobozi obutono mu nkola ya adrenaline eyasooka. Olw’amakubo asatu ag’enjawulo ag’okuvunda (oxidation, racemization ne sulfonation), obulamu bwayo obw’okutereka okusinga buba bumpi. Okwewozaako 1 okwa patent ya '876 kukiikirira:
Ekirungo ekirimu: nga 0.5 ku 1.5 mg/mL za epinephrine ne/oba omunnyo gwayo, nga 6 ku 8 mg/mL ez’ekirungo ekitereeza tonicity, nga 2.8 ku 3.8 mg/mL eky’ekirungo ekisitula pH, n’ekirungo ekiziyiza obuwuka obuleeta obuwuka nga 0.1 ku 1.1 mg/mL, ekirungo ekikendeeza pH 0.001 okutuuka ku 0.010 mL/mL ne nga 0.01 ku 0.4 mg/mL mL ez’ekirungo ekikola ebyuma ebikyukakyuka, nga ekiziyiza obuwuka obuleeta obulwadde buno kirimu sodium bisulfite ne/oba sodium metabisulfite.
(Kozesa ennukuta enzirugavu mu ndowooza okulaga obukwakkulizo obukwata ku kujulira kwa Hospira). Oluvannyuma lw’okunnyonnyola obukwakkulizo buno, endowooza yaleeta ekiteeso ky’okutaputa ekigambo “endagaano” kkooti y’eggombolola gye yakozesanga ku buli bukwakkulizo. Enjuyi zakkaanya bulungi nti ekigambo kino kirina okuba n’amakulu gaakyo aga bulijjo, nga gano “agakwata ku”; ku kkooti ejulirwamu eya Federal Circuit, Hospira teyawa nnyonyola ya kikontana n’ekyo.
Enjuyi zombi zaawa obujulizi bw’abakugu ku bukwakkulizo obusatu obwo waggulu. Abakugu ba Parr baawa obujulizi nti kkooti yakozesa 9 mg/mL sodium chloride okuzuula ekimenya amateeka mu bbanga eriri wakati wa 6-8 mg/mL (Hospira concentration, wadde nga n’obungi obutono nga 8.55 mg/mL nabwo bukozesebwa) kubanga it Kimala okutuukiriza ekigendererwa ekigendereddwamu, nga kino kwe “kukuuma obulungi bw’obutoffaali obulamu oluvannyuma lw’okukuba adrenaline mu musaayi.” Abakugu ba Hospira baakola kuwakanya banne ku oba abakugu be abakugu baali balowooza nti 9 mg/mL zagwa mu “nga” 6-8 mg/mL.
Ku bikwata ku buzibu bw’ebyuma ebikyukakyuka, kkooti y’eggombolola yakakasa nti asidi wa citric kirungo kya chelating ekimanyiddwa okusinziira ku bujulizi. Hospira yategeeza mu ANDA yaayo nti ebirimu obucaafu bwa elementi (ebyuma) biri mu mutindo gw’ensi yonna (naddala ICH Q3D) Guidelines). Abakugu ba Par bakakasizza nti enkolagana ekwatagana wakati w’ekintu ekituufu n’obungi bw’ekirungo ekikola ekyuma ekiyitibwa chelating agent ekiragiddwa mu bigambo ebigambibwa eri mu bbanga eryetaagisa. Abakugu ba Hospira nate tebaavuganya na bakugu ba Par okutwaliza awamu, naye kyakakasa nti ekkomo erya waggulu ery’omutindo gwa ICH Q3D gwali mutindo ogutasaana eri kkooti y’eggombolola. Wabula alowooza nti omuwendo ogusaanira gulina okuggyibwa mu kibinja kya Hospira ekigezesebwa, ky’alowooza nti kijja kwetaagisa asidi wa citric omutono ennyo ng’ekirungo ekikola chelating.
Enjuyi zombi zivuganya okukozesa ekirungo ekikendeeza pH ekya Hospira’s ANDA okulaga obungi bwa asidi wa citric nga buffer (ne sodium citrate ye). Mu nnimiro, asidi wa sitriki yennyini atwalibwa ng’ayongera ku pH (era tewali kubuusabuusa nti asidi wa siitiriki yennyini ye A pH lowering agent). Okusinziira ku bakugu ba Par, okuggyako obungi bwa asidi wa citric mu nkola ya Hospira kimala okufuula asidi wa citric okugwa mu bbanga ly’ekirungo ekikendeeza pH ekigamba nti Par. “Ne molekyu ezo ze zimu eza asidi wa citric zijja kufuuka ekitundu ku nkola ya buffer (Citric acid ne sodium citrate nga bigattiddwa bikozesebwa wamu ng’ekirungo ekilinnyisa pH.”(Wadde nga waliwo ebikontana ebyeyoleka, jjukira nti okumenya amateeka nsonga ya mazima. Federal Circuit ejja kwetegereza ensala ya kkooti y’essaza ey’amazima mu musango. Okusobola okutuuka ku nsobi eyeeyolese.) Abakugu ba Hospira tebakkiriziganya na Abakugu ba Par era ne bakakasa (mu ngeri entuufu) nti molekyu za asidi wa citric mu nkola eno tezirina kutwalibwa nga zombi ezikendeeza pH n’ezongera pH Kyokka kkooti y’eggombolola yasalawo nti Par yawangula omusango era ekiteeso kya Hospira kyandityoboola eddembe lya Par erya patent.
Omulamuzi Taranto yali alowooza nti olukiiko lwa Federal Circuit lwakakasizza nti omulamuzi Dyke n’omulamuzi Stoll nabo beetabye mu lukiiko luno. Okujulira kwa Hospira kwalimu okusalawo kwa kkooti y’eggombolola ku buli emu ku bukwakkulizo busatu. Federal Circuit yasooka kukakasa ebyazuulibwa kkooti ya Disitulikiti mu ndowooza yaayo nti ekirungo kya 9 mg/mL sodium chloride mu ddagala lya Hospira mu butuufu kyagwa mu kkomo “nga” 6-8 mg/mL eryagambibwa Par. Ekibiina ky’abakugu kyalaga nti bw’okozesa ekigambo “nga”, “wewale okukozesa ensalo z’omuwendo enkakali ku bipimo ebiragiddwa,” Cohesive Techs bwe yayogeddeko. v. Water Corp., 543 F. 3d 1351 (Fed. Cir. 2008), nga kyesigamiziddwa ku Pall Corp. v. Micron Separations, Inc., 66 F. 3d 1211, 1217 (Fed. Cir. 1995). Nga tujuliza ekigambo kya Monsanto Tech, “ebikwata ku” bwe bikyusiddwa mu kwewozaako, omuwendo gw’omuwendo ogugambibwa guyinza okugaziwa okusukka eddaala okutuuka ku ddaala omuntu omukugu lw’ajja “okulowooza mu ngeri entuufu” obuwanvu obukwatibwako mu kwewozaako. LLC v. EI DuPont de Nemours & Co., 878 F.3d 1336, 1342 (Kkooti ya Federo 2018). Mu mbeera ng’ezo, singa tewali ludda lwonna luwagira kukendeeza ku bunene bw’okusaba, okusalawo kwesigamiziddwa ku mutindo gw’okukwatagana. Ebintu ebiri mu mutindo guno mulimu oba enkola egambibwa nti emenya amateeka “ya kigero” okuva ku bunene bw’obukuumi (Conopco, Inc. v. May Dep’t Stores Co., 46 F.3d 1556, 1562 (Federal Court, 1994). )) , Era engeri obuwanvu bw’obukuumi gye bukulu nnyo n’ekigendererwa eky’okussa ekkomo (si kuyiiya kuno) yennyini. Wadde nga kyakkiriza nti okuwoza kuno kukola kinene mu kusalawo kwa kkooti ku nsonga eno, Federal Circuit yalaga nti: “Oba ekyuma ky’omuwawaabirwa kituukana n’amakulu “ag’omuwawaabirwa” amatuufu mu mbeera ezimu nsonga ya tekinologiya,” v. US Int’l Trade Comm’, 75 F.3d 1545, 1554 (Federal Court, 1996). Wano, akakiiko kalowooza nti kkooti y’eggombolola mu ngeri esaanidde yeettanira enkola eyogeddwako wano, era okusalawo kwayo kwesigamiziddwa ku bujulizi bw’abakugu. Kkooti y’Essaza yagamba nti abakugu ba Par baali bamatiza nnyo okusinga abakugu ba Hospira, naddala okutuuka ku kigero nti yeesigamye ku “nsonga ez’ekikugu, obukulu bw’ekigendererwa ky’okuziyiza, n’obutavumirira bukwakkulizo obwo.” Okwawukana ku ekyo, kkooti y’omu disitulikiti yagamba nti abakugu mu Hospira “tebaakola kwekenneenya kwa makulu ku by’ekikugu oba omulimu gw’ekintu ekigambibwa nti kikyusa tonicity.” Okusinziira ku nsonga zino, akakiiko k’abakugu tebaazudde nsobi yonna eyeeyolese.
Ku bikwata ku buzibu obuli mu ba agenti abakola ebyuma ebikyusa ebyuma, Federal Circuit yagaana ensonga ya Hospira nti kkooti ya disitulikiti yandibadde essira erisinga kulissa ku nkola yaayo eya bulijjo okusinga ebiragiro ebiri mu ANDA yaayo. Akakiiko kakizudde nti Kkooti y’Essaza mu butuufu yatunuulira asidi wa citric ng’ekirungo ekikola ebyuma ebikyukakyuka (transition metal complexing agent) ekyogerwako mu kwewozaako, ekikwatagana n’obujulizi bw’abakugu obw’enjuyi zombi. Okusinziira ku bujulizi nti mu butuufu asidi wa sitriki akola ng’ekirungo ekiziyiza okuzimba omubiri (chelating agent), endowooza eno egaana ensonga ya Hospira nti asidi wa citric tagendereddwamu kukozesebwa nga ekirungo ekikola ekirungo ekiziyiza okuzimba (chelating agent). Okusinziira ku 35 USC§271(e)(2), omutindo gw’okusalawo okumenya amateeka mu misango gya ANDA bye birimu ebyogeddwako mu ANDA (nga kkooti bwe yalambika, kumenya amateeka okuzimba), ng’ejuliza Sunovion Pharm. , Inc. mu musango gw’ekitongole kya Teva Pharm. , USA, Inc., 731 F.3d 1271, 1279 (Kkooti ya Federo, 2013). Hospira okwesigama ku ANDA yaayo gwe mutindo gwa ICH Q3D, oguwagira ensala ya kkooti y’eggombolola, waakiri si kubanga ekiwandiiko kino kyayongerwa ku ANDA oluvannyuma lwa FDA okwetaaga “amawulire amalala” mu kitundu kino. ANDA teyasirika ku nsonga eno. Federal Circuit yakizudde nti kkooti y’omu disitulikiti yalina obujulizi obumala okukakasa nti sitatimenti ya Hospira yagoberera mu bujjuvu obukwakkulizo obwo.
N’ekisembayo, ku bikwata ku pH-influencing properties ya citric acid ne buffers zaayo, Federal Circuit yasinziira ku Hospira kye yagamba era teyalina ddembe kusaba ku nsonga eno. Okugatta ku ekyo, olukiiko lwa Federal Circuit lwakimanya nti akakiiko kaali kagamba nti ebiragiro (ebyo bye bimu) ebiri mu patent za ’876 ne ’657 “waakiri biraga nnyo ekintu ekikontana n’ekyo.” Okuva Kkooti ya Federo bwe teyawakanya kwewozaako kuno (oba ekifo ekirala kyonna), Kkooti ya Federo yagamba nti Kkooti ya Disitulikiti tetuuka ku nkomerero eyeeyolese nti enkola ya Hospira yamenya okuwoza okwannyonnyolwa (mu bintu ebirala, kino) Kisinziira ku biri mu kkooti mu lujjudde). Specifications) era nga zikakasiddwa.
Par Pharmaceutical, Inc. v. Hospira, Inc. (Kkooti ya Federo 2020) Akakiiko: Endowooza z’omulamuzi w’ekitundu Dyk, Taranto ne Stoll, omulamuzi w’ekitundu Taranto
Okwewala: Olw’obutonde bw’okulongoosa kuno okwa bulijjo, amawulire agaweereddwa wano gayinza obutakwata ku mbeera zonna, era tewali kikolebwa ku mawulire gano awatali kuwabulwa mu mateeka okwetongodde okusinziira ku mbeera ezenjawulo.
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