Kuva kera, abantu bizeraga ko imiterere y'ibirego ishobora kandi akenshi igira uruhare rukomeye mu manza z'ipatanti. Uku kuvuga ukuri ni yo shingiro ry'Urwego rw'Igihugu rwemeza icyemezo cy'urukiko rw'akarere ku ruganda rukora imiti isanzwe mu rubanza ruheruka rw'Akarere rwa Pharmacopoeia mu rubanza rwa Par Pharmaceutical, Inc. na Hospira, Inc.. Kurenga ku mategeko ya Par afite patenti, amahame y'amakosa asobanutse nabyo byagize ingaruka ku bisubizo.
Ibi bibazo byatewe n'urubanza rwa ANDA, aho urega yasabaga ko Hospira ya Amerika ifite Patenti Nomero 9,119,876 na 9,925,657 ku bijyanye na Par's Adrenalin® (adrenaline) n'uburyo bwo kuyikoresha (injection). Hospira yashyigikiye ko hatabaho kurenga ku mategeko no kutayubahiriza nk'ubwunganizi (urukiko rw'akarere rwatanze ikirego kuri Hospira bityo ntirwajuririye). Patenti ya Par igamije uburyo bwo kugabanya inenge z'uburyo bwa adrenaline bwa kera. Bitewe n'inzira eshatu zitandukanye zo kwangirika (oxidation, racemization na sulfonation), igihe cyayo cyo kurangira ni gito cyane. Ikirego cya 1 cya patenti ya '876 ni:
Ibigize: hafi 0.5 kugeza 1.5 mg/mL bya epinephrine cyangwa umunyu wayo, hafi 6 kugeza 8 mg/mL by'icyuma gipima ubukana bw'amaraso, hafi 2.8 kugeza 3.8 mg/mL by'igikoresho gitera pH kuzamura, hamwe na antioxydant iri hagati ya 0.1 na 1.1 mg/mL, pH igabanya 0.001 kugeza 0.010 mL/mL na hafi 0.01 kugeza 0.4 mg/mL by'igikoresho gitera metal complexing, aho antioxydant irimo sodium bisulfite na/cyangwa sodium metabisulfite.
(Koresha inyuguti igaragara mu gitekerezo kugira ngo ugaragaze inzitizi zijyanye n'ubujurire bwa Hospira). Nyuma yo gusobanura izi ngamba, igitekerezo cyatanze ibisobanuro by'ijambo "isezerano" rikoreshwa n'urukiko rw'akarere kuri buri ngamba. Impande zombi zemeranyije neza ko iryo jambo rigomba kugira ibisobanuro byaryo bisanzwe, ari byo "kureba"; ku Rukiko rw'Ubujurire rwa Leta, Hospira ntiyatanze ibisobanuro bivuguruza ibyo.
Impande zombi zatanze ubuhamya bw'inzobere ku mategeko atatu yavuzwe haruguru. Impuguke za Parr zavuze ko urukiko rwakoresheje 9 mg/mL sodium chloride kugira ngo rumenye niba hari ikibazo kiri hagati ya 6-8 mg/mL (ibipimo bya Hospira, nubwo nabyo bikoreshwa ku gipimo kiri hasi cya 8.55 mg/mL) kuko bihagije kugira ngo bigere ku ntego yari iteganyijwe, ari yo "kubungabunga ubusugire bw'uturemangingo tuzima nyuma yo gutera adrenaline mu maraso." Impuguke za Hospira zagaragaje gusa ko abatekinisiye be b'inzobere bemeraga ko 9 mg/mL iri mu gipimo "kigera kuri" 6-8 mg/mL.
Ku bijyanye n’imbogamizi z’ibikoresho by’icyuma bihinduka, urukiko rw’ibanze rwemeje ko aside citric ari ikintu kizwi cya chelating hashingiwe ku bimenyetso. Hospira yavuze muri ANDA yayo ko ingano y’imyanda y’ibintu (ibyuma) iri mu mahame mpuzamahanga (cyane cyane ICH Q3D) Amabwiriza). Impuguke za Par zerekanye ko isano iri hagati y’ibicuruzwa bisanzwe n’ingano y’ibikoresho bya chelating by’icyuma bivugwa mu birego iri mu rugero rusabwa. Impuguke za Hospira zongeye guhangana n’impuguke za Par muri rusange, ariko byagaragaje ko urugero rwo hejuru rw’amahame ya ICH Q3D rwari urugero rudakwiriye urukiko rw’akarere. Ahubwo, yizera ko ingano ikwiye igomba gukurwa mu cyiciro cy’ibizamini bya Hospira, yizera ko bizakenera aside citric iri hasi cyane nk’ikintu cya chelating.
Impande zombi zirahatanira gukoresha ANDA ya Hospira igabanya pH kugira ngo igaragaze ingano ya aside citric nk'ikintu gifasha mu kugabanya pH (na sodium citrate yayo). Muri urwo rwego, aside citric ubwayo ifatwa nk'iyongera pH (kandi nta gushidikanya ko aside citric ubwayo ari igikoresho cya A gigabanya pH). Nk'uko impuguke za Par zibivuga, gukuramo ingano ya aside citric muri formula ya Hospira bihagije kugira ngo aside citric igere mu rugero rw'ikintu gigabanya pH cyavuzwe na Par. “Ndetse n’izo molecule zimwe za aside citric zizahinduka igice cya sisitemu y’ubutabazi (aside Citric na sodium citrate bivanze bikoreshwa hamwe nk’umuti wongera pH.” (Nubwo hari ukuvuguruzanya kugaragara, ibuka ko kurenga ku mategeko ari ikintu cy’ukuri. Urwego rw’Igihugu ruzasuzuma icyemezo cy’ukuri cyafashwe n’urukiko rw’akarere mu rubanza. Kugira ngo haboneke ikosa rigaragara.) Impuguke za Hospira ntizemeranya n’impuguke za Par kandi zagaragaje (mu buryo bufatika) ko molecule za aside citric ziri mu buryo bw’isuku zidakwiye gufatwa nk’izigabanya pH n’iziyongera pH. Ariko, urukiko rw’akarere rwemeje ko Par yatsinze urubanza kandi icyifuzo cya Hospira cyabangamira uburenganzira bwa Par bwo gutanga patenti. Ubu bujurire bwakurikiyeho.
Umucamanza Taranto yizeye ko Urwego rw’Igihugu rwemeje ko Umucamanza Dyke n’Umucamanza Stoll nabo bitabiriye inama. Ubujurire bwa Hospira bwashingiye ku cyemezo cy’urukiko rw’akarere kuri buri tegeko ribuza. Urwego rw’Igihugu rwemeje mbere ibyavuye mu Rukiko rw’Akarere mu gitekerezo cyarwo ko igipimo cya 9 mg/mL sodium chloride mu mvange ya Hospira kiri mu rugero rwa "hafi" 6-8 mg/mL ruvugwa na Par. Itsinda ry’impuguke ryagaragaje ko iyo ukoresheje ijambo "hafi", "wirinde gukoresha imipaka ikomeye y’imibare ku bipimo byagenwe," nk'uko Cohesive Techs yabitangaje. v. Water Corp., 543 F. 3d 1351 (Fed. Cir. 2008), hashingiwe kuri Pall Corp. v. Micron Separations, Inc., 66 F. 3d 1211, 1217 (Fed. Cir. 1995). Dukurikije imvugo ya Monsanto Tech, iyo "hafi" yahinduwe mu kirego, umubare w'imibare wavuzwe ushobora kwaguka ukarenga urugero ku buryo umuntu w'umuhanga "azasuzuma mu buryo bushyize mu gaciro" urugero rukubiye mu kirego. LLC v. EI DuPont de Nemours & Co., 878 F.3d 1336, 1342 (Urukiko rwa Leta 2018). Muri ibyo bihe, niba nta ruhande n'umwe ushyigikiye kugabanya urugero rw'ikirego, icyemezo gishingiye ku mahame y'ubufatanye. Ibintu bigize aya mahame birimo niba formula ivugwa ko inyuranyije n'amategeko ari "iciriritse" uhereye ku rwego rwo kurinda (Conopco, Inc. v. May Dep't Stores Co., 46 F.3d 1556, 1562 (Urukiko rwa Leta zunze Ubumwe za Amerika, 1994). )) , Kandi se uburyo inshingano zo kurinda ari ingenzi cyane hagamijwe kugabanya (atari ubu buvumbuzi) ubwabwo. Nubwo bemera ko ikirego ari umusanzu mu cyemezo cy’urukiko kuri iki kibazo, Urwego rw’Igihugu rwagaragaje ko: “Kuba uburyo bw’uregwa bwujuje “amasezerano” akwiye mu bihe bimwe na bimwe ni ikibazo cy’ibimenyetso bya tekiniki,” v. US Int'l Trade Comm', 75 F.3d 1545, 1554 (Urukiko rwa Leta, 1996). Aha, akanama gatekereza ko urukiko rw’akarere rwafashe icyemezo gikwiye cyavuzwe hano, kandi icyemezo cyarwo gishingiye ku buhamya bw’impuguke. Urukiko rw’Akarere rwemeje ko impuguke za Par zari zishoboye kwemeza kurusha impuguke za Hospira, cyane cyane ko zishingiye ku “bintu bya tekiniki, akamaro k’intego y’icyo kibazo, no kudasuzuma icyo kibazo.” Ibinyuranye n’ibyo, urukiko rw’akarere rwemeje ko impuguke za Hospira “zitakoze isesengura ry’imiterere y’ikoranabuhanga cyangwa imikorere y’ikintu cyavuzwe ko gihindura imiterere y’umubiri.” Hashingiwe kuri ibi bintu, akanama k’impuguke nta makosa kabonye.
Ku bijyanye n’imbogamizi z’ibikoresho byo gukurura ibyuma bihindura imiterere y’icyuma, Urwego rw’Igihugu rwanze ingingo ya Hospira ivuga ko urukiko rw’akarere rwagombaga kwibanda ku buryo rusange rwatanze aho kwibanda ku ngingo ziri muri ANDA yayo. Inteko Ishinga Amategeko isanga Urukiko rw’Akarere rwafashe neza aside citric nk’igikoresho cyo gukurura ibyuma bihindura imiterere y’icyuma cyavuzwe mu kirego, ibi bikaba bihuye n’ubuhamya bw’impuguke bw’impande zombi. Hashingiwe ku buhamya bw’uko aside citric ikora nk’igikoresho cyo gukurura imiterere y’icyuma, iki gitekerezo cyanze ingingo ya Hospira ivuga ko aside citric idagenewe gukoreshwa nk’igikoresho cyo gukurura imiterere y’icyuma. Dukurikije ingingo ya 35 USC§271 (e) (2), igipimo ngenderwaho cyo kwemeza ihohoterwa mu manza za ANDA ni ibikubiye muri ANDA (nk’uko urukiko rwabigaragaje, ni ukwica amategeko y’ubwubatsi), dushingiye kuri Sunovion Pharm., Inc. v. Teva Pharm., USA, Inc., 731 F.3d 1271, 1279 (Urukiko rwa Leta, 2013). Kuba Hospira ishingira kuri ANDA yayo ni ibipimo ngenderwaho bya ICH Q3D, bishyigikira umwanzuro w'urukiko rw'akarere, nibura atari ukubera ko iyi nyandiko yongewe kuri ANDA nyuma y'uko FDA isabye "andi makuru" kuri iki kibazo. ANDA ntiyacecetse kuri iki kibazo. Urwego rw'Igihugu rwasanze urukiko rw'akarere rufite ibimenyetso bihagije bigaragaza ko ibyo Hospira yavuze byujuje ibisabwa byose.
Amaherezo, ku bijyanye n’imiterere ya aside citric n’ibinyabutabire byayo bigira ingaruka kuri pH, Urwego rw’Igihugu rushingiye ku kirego cya Hospira kandi ntirwihaye uburenganzira bwo gusaba kuri iki kibazo. Byongeye kandi, Urwego rw’Igihugu rumaze kumenya ko akanama kemeje ko ibisobanuro (bimwe) bya patenti za '876 na '657 "byibura bigaragaza ibinyuranye n’ibyo." Kubera ko Urukiko rw’Igihugu rutigeze ruvuguruza iki kirego (cyangwa ikindi kintu icyo ari cyo cyose), Urukiko rw’Igihugu rwemeje ko Urukiko rw’Akarere rutageze ku mwanzuro ugaragara w’uko inyandiko ya Hospira yanyuranyije n’ikirego cyasobanuwe (mu bindi, ibi) Biterwa n’ibivugwa mu ruhame n’urukiko). Ibisobanuro) kandi byemezwa.
Par Pharmaceutical, Inc. v. Hospira, Inc. (Urukiko rw'Urugereko rwa Leta 2020) Akanama: Ibitekerezo by'Umucamanza w'Urugereko Dyk, Taranto na Stoll, Umucamanza w'Urugereko Taranto
Icyitonderwa: Bitewe n'imiterere rusange y'iri vugurura, amakuru atangwa hano ashobora kuba adakoreshwa mu bihe byose, kandi nta gikorwa na kimwe gikwiye gukorwa kuri aya makuru hatabayeho inama z'amategeko zihariye hashingiwe ku bihe runaka.
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