Kumara obwire buraingwa, abantu batwire nibaikiriza ngu omutindo gw‘okushaba nigubaasa kandi obwire obwingi nigukora omurimo gw‘okucwamu omu kushaba obugabe bw‘okushaba. Okugamba amazima oku nikyo kirikureetera kooti ya disiturikiti kuhamya ensharamu ya kooti ya disiturikiti aha mukozi w’emibazi y’omutaano omu nsharamu eyahererukireyo ey’ekitabo ky’emibazi ekya disiturikiti omu mushango gwa Par Pharmaceutical, Inc. v. Hospira, Inc. Okuhenda ebiragiro bya Par ebiine obugabe, emitindo y‘enshobi erikureebwa gye nayo ekaba eine eki yaakozire aha byarugamu.
Ebizibu ebi bikaruga omu kushaba kwa ANDA, ahu omujulizi yaabaire naashaba obugabe bwa Hospira obw’omu Amerika namba 9,119,876 na 9,925,657 aha bikwatiraine na Par’s Adrenalin® (adrenaline) n’omuringo gw’okugiha (okugiteera). Hospira akashagika obutahenda ebiragiro n’okutakora nk’okwetonganira (kooti ya disiturikiti ekataho okwetonganira ahari Hospira n’ahabw’ekyo tiyajurira). Patent ya Par neegyenderera okukora omubazi ogurikusingura oburemeezi bw’omubazi gw’okubanza ogwa adrenaline. Ahabw’emihanda eshatu etari emwe n’emwe ey’okusheenya (okuhindura ebiriisa, okuhindura ebiriisa n’okuhindura ebiriisa), obwire bwayo bw’okugumaho nibukira kuba bukye. Okushaba 1 okwa '876 patent nikujwekyera:
Ekirungo ekirimu: nka 0.5 kuhika 1.5 mg/mL ya epinephrine na/nari omunyugunyu gwayo, nka 6 kuhika 8 mg/mL y‘ekirungo ky‘okutegyeka amaani, nka 2.8 kuhika 3.8 mg/mL y‘ekirungo ky‘okutunguura pH, n‘ekirungo ky‘okurwanisa obukooko oburikwingana 0.1 kuhika 1.1. mL/mL na nka 0.01 kuhika 0.4 mg/mL mL y‘ekintu ekirikuhindura eby‘ekyoma, ahu ekirikurwanisa obukooko kirimu sodium bisulfite na/nari sodium metabisulfite.
(Koresa enyuguta ezigumire omu kiteekateeko kworeka obuzibu oburikukwata aha kujurira kwa Hospira). Bwanyima y’okushoboorora obuzibu obu, ekiteekateeko kikareetaho okushoboorora ekigambo “endagaano” eki kooti ya disiturikiti yaakoreise ahari buri buzibu. Ebibiina bikaikirizana gye ngu ekigambo eki kiine kuba kiine amakuru gaakyo aga buriijo, agarikugira ngu “aha”; aha kooti y’okujuririra eya Federo, Hospira tarahaire nshoboorora erikuhakanisa.
Enshonga zombi zihaire obujurizi bw’abakugu aha buzibu obushatu obu aharuguru. Abakugu ba Parr bakaha obujurizi ngu kooti ekakoresa 9 mg/mL sodium chloride kumanyisa okuhenda ebiragiro omu nkora ya 6-8 mg/mL (okutaho Hospira, n‘obu okutaho ebiri ahansi nka 8.55 mg/mL nabyo birikukoresibwa) ahabw‘okuba nikimara kuhikiiriza ekigyendererwa ky‘okutaho obutafaari bwanyima y‘okutaho obutafaari, obu adrenaline omu shagama.” Abakugu ba Hospira bakareetaho okuhakanisa kwonka ahari bagyenzi be aha ku abakozi be abaine obukugu barikwikiriza ngu 9 mg/mL neegwa omu “enkumi” 6-8 mg/mL.
Aha bikwatiraine n’obugarukiro bw’ebyoma ebirikuhinduka, kooti ya disiturikiti ekahamya ngu citric acid n’ekintu ekimanyirwe ekirikureetaho okusheeshasheesha kurugiirira aha buhame. Hospira ekagamba omu ANDA yaayo ngu ebiri omu bihingwa (ebyoma) biri omu mutindo gw’ensi yoona (na munonga ICH Q3D) Guidelines). Abakugu ba Par bakahamya ngu akakwate akarikuhikaana ahagati y‘ekintu ekihikire n‘ekicweka ky‘ekyoma ekirikureetaho okusheeshasheesha ekigambirweho omu kushaba kiri omu nkora erikwetengyesa. Abakugu ba Hospira nabo tibarikuhakanisa abakugu ba Par omu bwijwire, kwonka kikahamya ngu ekipimo kya ruguru eky’omutindo gwa ICH Q3D gukaba guri omutindo ogutahikire ahari kooti ya disiturikiti. Kureka, nateekateeka ngu omuhendo oguhikire gushemerire kuruga omu kicweka ky’okukyebera ekya Hospira, eki arikuteekateeka ngu nikiija kwetenga ebiriisa bya citric acid ebiri ahansi munonga nk’ekintu ekirikureetaho okusheeshasheesha.
Ebibiina ebi byombi nibirwanira kukoresa omubazi ogurikukyendeeza pH ogwa Hospira ogwa ANDA kushoboorora oku citric acid eri nk’ekintu ekirikuzibira (na sodium citrate yaayo). Omu musiri, citric acid ahabwayo neeteekateekwaho kwongyera aha pH (kandi tihaine kubangaanisa ngu citric acid ahabwayo n’ekintu ekirikukyendeeza pH). Okurugirira aha bakugu ba Par, okuihaho omubaro gwa citric acid omu nkora ya Hospira nikimara kureetera citric acid kugwa omu nkora y’ekintu ekirikukyendeeza pH eki Par arikugira. “N’obu molecules ezo nizo zimwe eza citric acid niziija kuba kimwe aha nkora ya buffer (Citric acid na sodium citrate eziteeraine nizikoresibwa hamwe nk’ekintu ekirikutunguura pH” (N’obu haraabe hariho okuhakanisa okurikureebwa, ijuka ngu okuhenda ebiragiro n’enshonga y’amazima. Abakugu ba Hospira tibarikwikirizana n’abakugu ba Par kandi bakahamya (omu muringo oguhikire) ngu molekyu za citric acid eziri omu nkora tiziine kuteekateekwaho nk’ezirikukyendeeza pH n’ezirikwongyera aha pH Kwonka kooti ya disiturikiti ekacwamu ngu Par akasinga omushango ogu kandi ekiteiso kya Hospira kikaba nikiija kuhenda obugabe bwa Par.
Omuramuzi Taranto akagira ngu kooti ya Federal Circuit ekahamya ngu omuramuzi Dyke n’omuramuzi Stoll nabo bakaba bari omu rukiiko oru. Okujurira kwa Hospira kukaba kurimu okucwamu kwa kooti ya disiturikiti ahari buri kimwe aha biragiro bishatu. Ekitongore kya Federal Circuit kikabanza kyahamya ebyarugire omu kooti ya disiturikiti omu kuteekateeka kwayo ngu omubaro gw’ekiriisa kya sodium chloride 9 mg/mL omu nkora ya Hospira buzima kikagwa omu “kipimo” kya 6-8 mg/mL eki Par. Ekibiina ky’abakugu kikashoboorora ngu baaba nibakoresa ekigambo “enkumi n’enkumi”, “yetantare okukoresa ensharo z’omubaro ezigumire ahabw’ebintu ebimanyirwe,” Cohesive Techs nikwo yaajuriza. v. Amaizi Corp., 543 F. 3d 1351 (Fed. Cir. 2008), kurugiirira aha Pall Corp. Okujuriza ekigambo kya Monsanto Tech, “about” ku erikuhindurwa omu kushaba, omubaro gw‘okushaba nigubaasa kwongyerwamu amaani kurenga aha rurengo kuhika aha rurengo oru omuntu oine obukugu arikwija “kuteekateeka omu muringo oguhikire” aha rulengo orurikugambwaho omu kushaba. LLC n’omushango gwa EI, 878 F.3d 1336, 1342 (Kooti y’eihanga 2018). Omu mbeera nk‘ezi, haaba hatariho rubaju rwona orurikuhagira okukyendeeza aha bugabe bw‘okushaba, okucwamu nikurugiirira aha mutindo gw‘obumwe. Ebintu by‘omutindo ogu birimu yaaba enkora erikuteekateekwaho kuhenda ebiragiro eri “ey‘omutindo” kuruga omu nkora y‘obukuumi (Conopco, Inc. v. May Dep‘t Stores Co., 46 F.3d 1556, 1562 (Kooti y‘eihanga, 1994). )) , n‘oku oburinzi oburiho hati buri bukuru ahabw‘ekikomo ky‘obukuumi oburiho hati omu)) . ahabwayo. N’obu baraabe baikiriize ngu okushaba okwo nikureetaho okucwamu kwa kooti aha nshonga egi, Federal Circuit ekagira eti: “Okuba ekikwato ky’omujulizi nikihikiiriza amakuru ga “endagaano” agahikire omu mbeera ezimwe n’enshonga y’eby’obuhangwa,” v. US Comm’l’l,53de 153 . 1554 (Kooti y’eihanga, 1996). Aha, akakiiko aka nikateekateeka ngu kooti ya disiturikiti ehikire omu nkora erikushoboororwa aha, kandi okucwamu kwayo nikurugiirira aha bujurizi bw’abakugu. Kooti ya Disiturikiti ekagira ngu abakugu ba Par bakaba nibahamiza kimwe okukira abakugu ba Hospira, na munonga kuhika aha rurengo oru yaabaire neeyesiga “amazima g’eby’obuhangwa, obukuru bw’ekigyendererwa ky’okuzibira, n’okutagira nshonga.” Okutaana n’ekyo, kooti ya disiturikiti ekagira ngu abakugu ba Hospira “tibarakozire okucondooza okuhikire aha bikwatiraine n’eby’obuhangwa nari omurimo gw’ekintu ekirikugambwaho ngu nikihindura omubiri.” Okurugirira aha mazima aga, akakiiko k’abakugu tikashangireho enshobi yoona erikureebwa.
Aha bikwatiraine n’obugarukiro bw’abakozi b’ebyoma ebirikuhindura ebyoma, Federal Circuit ekayanga enshonga ya Hospira ngu kooti ya disiturikiti ekaba eine kuta omutima aha nkora yaayo ey’omutaano erikuteekateekwaho beitu kutari aha biragiro ebiri omu ANDA yaayo. Ekibiina nikishanga ngu kooti ya disiturikiti ekatwara omu muringo oguhikire citric acid nk’ekintu ekirikureetaho okugumizamu kw’ebyoma ebirikuhinduka ekishobooroirwe omu kushaba, ekirikuhikaana n’obujurizi bw’abakugu b’enjuyi zombi. Okurugirira aha bujurizi oburikworeka ngu citric acid buzima neekora nk’ekintu ekirikureetaho okusheeshasheesha, enteekateeka egi neeyanga enshonga ya Hospira ngu citric acid tegyendereirwe kukoresibwa nk’ekintu ekirikureetaho okusheeshasheesha. Okurugirira ahari 35 USC§271(e)(2), omutindo gw‘okucwamu aha kuhenda ebiragiro omu kushaba kwa ANDA n‘ebiri omu ANDA (nk‘oku kooti yaayorekire, n‘okuhenda ebiragiro okurikwombeka), barikujuriza Sunovion Pharm. , Inc. n’omubazi gwa Teva. , USA, Inc., 731 F.3d 1271, 1279 (Kooti y’eihanga, 2013). Hospira okwesiga ANDA yaayo n’omutindo gwa ICH Q3D, ogurikuhagira ensharamu ya kooti ya disiturikiti, haakiri ti habw’okugira ngu ekihandiiko eki kikongyerwa aha ANDA bwanyima ya FDA kwetenga “amakuru agandi” omu mwanya ogu. ANDA terikuguma ecumire aha nshonga egi. Federal Circuit ekashanga ngu kooti ya disiturikiti ekaba eine obuhame oburikumara kuhamya ngu ebigambo bya Hospira bikahikaana n’obuzibu obu.
Eky’aha muheru, aha bikwatiraine n’emitwarize y’okuhindura pH ya citric acid n’ebirikugizibira, Federal Circuit ekagyendera aha ki Hospira yaagambire kandi ekaba etaine bugabe bw’okugira aha nshonga egi. Okwongyera ahari ekyo, Federal Circuit ekamanya ngu akakiiko aka kakagira ngu ebihandiiko (nibyo bimwe) ebyabaire biri omu bihandiiko bya ’876 na ’657 “haakiri nibyoreka munonga ekirikushushana n’ekyo.” Ahabw‘okugira ngu kooti ya Federo terikuhakanisa eki (nari omwanya gwona), kooti ya Federo ekagira ngu kooti ya disiturikiti tehikire aha nshonga erikureebwa gye ngu enkora ya Hospira ekahenda ekigambo ekishobooroirwe (omu bintu ebindi, eki) Nikirugiirira aha biri omu kooti omu bantu). Ebirikushoboorora) kandi bikahamibwa.
(Kooti y’eihanga 2020) Ekibiina: Ebiteekateeko by’omuramuzi w’eihanga Dyk, Taranto na Stoll, omuramuzi w’eihanga Taranto
Okwehakana: Ahabw’okugira ngu amakuru aga nigakwata aha bantu boona, amakuru agarikuheebwa aha nigabaasa kutakora aha mbeera zoona, kandi tihaine eki oine kukora aha makuru aga hatariho buhabuzi bw’ebiragiro oburikurugiirira aha mbeera ezimwe.
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