Kwachiindi chilamfu, bantu basyoma kuti bupange bwazipego bulakonzya alimwi kanjikanji bulaa lubazu lupati mumilandu ya patent. Ooku kwaamba chakutainda mumbali ncecipa kuti Federal Circuit isinizye kusala kwa nkuta yamuchilawu kuli sikupanga misamu iikola mumulandu wamamanino wa District Pharmacopoeia mumulandu wa Par Pharmaceutical, Inc. v. Hospira, Inc.. Kutyola mulawu wa Par, zyeelelo zyakulubizya zisalala azyalo zyakaba aampindu kuzintu zyakazwa.
Mapenzi aaya akaletwa mumulandu wa ANDA, oomo sikutamikizya mwaakaamba Hospira's US Patent Nos. 9,119,876 antoomwe a 9,925,657 kujatikizya Par's Adrenalin® (adrenaline) anzila yakuubelesya (injection). Hospira yakakulwaizya kutatyola mulawu akubula nguzu mbuli nzila zyakulikwabilila (nkuta yamuchilawu yakabikka lukwabililo kuli Hospira aboobo tiiyakachita apilu). I Par patent ilaa makanze aakupanga zintu zikonzya kuzunda tumpenda twakupanga zintu zyakusaanguna zya adrenaline. Akaambo kanzila zyotatwe zyakunyonyooka (kusanduka, kusanduka kwamusyobo a sulfonation), buumi bwayo mbufwiifwi. Chizuminano 1 cha '876 patent nchiiminina:
Bupange bujisi: aali 0.5 kusikila ku 1.5 mg/mL ya epinephrine a/naa munyo wayo, aali 6 kusikila ku 8 mg/mL ya tonicity regulator, aali 2.8 kusikila ku 3.8 mg/mL ya musamu uusumpula pH, antoomwe a antioxidant uusika ku 0.1 kusikila ku 1.1 mg/mL, musamu uucesya pH kusikila ku 10.100.00. mL/mL antoomwe a 0.01 kusika ku 0.4 mg/mL mL ya transition metal complexing agent, oomo antioxidant moibikkilizya sodium bisulfite antoomwe a sodium metabisulfite.
(Belesya mabala mapati mumuzeezo kutondezya zisinkilizyo zijatikizyidwe akulomba kwa Hospira). Nikwakamana kupandulula zisinkilizyo eezyi, muzeezo wakapa bupanduluzi bwabbala lyakuti "chizuminano" lyakabelesyegwa ankuta yamuchilawu kuli zisinkilizyo zyoonse. Basikuzuminana bakazuminana kuti bbala eeli lyeelede kuba abupanduluzi bwalyo bwabuzubaa buzuba, bwakuti "aatala"; ku Nkuta Mpati ya Federal Circuit, Hospira tanaakapa bupanduluzi bwakukazya.
Boonse bobile bakapa bumboni bwabasyaazibwene aatala azilesyo zyotatwe zili atala aawa. Basyaazibwene ba Parr bakapa bumboni bwakuti nkuta yakabelesya 9 mg/mL ya sodium chloride kuzyiba kutyola mulawu aakati ka 6-8 mg/mL ( Hospira concentration, nikuba kuti concentrations zili munsi a 8.55 mg/mL azyalo zilabelesyegwa) nkaambo zilazula kuzuzikizya makanze aakabikkidwe, aakuti “kubamba kusyomeka kwamaseelo mumulongo wamana gazi." Basyaazibwene ba Hospira bakakazya buyo kuli basimilimonyina kuti naa basyaazibwene bakwe bakali kusyoma kuti 9 mg/mL yakali mukati ka “aafwaafwi” 6-8 mg/mL.
Kujatikizya kulezya kwatunsimbi twakucinca, nkuta yamuchilawu yakasinizya kuti asidi ya citric nchintu chizyibidwe kuti nchintu chipa kuti kube chelating agent kweendelanya abumboni. Hospira yakaamba mu ANDA yayo kuti zili mukati kazintu zisofweede (zibulo) zili mukati kazyeelelo zyanyika yoonse (ikapati ICH Q3D) Malailile). Basyaazibwene ba Par bakasinizya kuti kujatana aakati kachintu chili kabotu antoomwe abunji bwazintu zipangwa abutale bwaambwa mukwaamba zili mukati kazyeelelo zyeelede. Basyaazibwene ba Hospira alimwi tiibakazundana abasyaazibwene ba Par boonse, asi chakatondezya kuti munyinza wa ICH Q3D wakali munyinza uutali kabotu kunkuta yamuchilawu. Muciindi, ulasyoma kuti mweelwe weelede weelede kugwisigwa kuzwa ku Hospira's test batch, walo ngwasyoma kuti uyandika mweelwe musyoonto wa citric acid mbuli chelating agent.
Mabambe aaya obile ali mukuzundana kubelesya musamu uugwisya pH wa Hospira's ANDA kuti atondezye bunji bwa asidi ya citric mbuli chikwabilizyo (a sodium citrate). Mumulimo, asidi ya citric ilabonwa kuti ilayungizya pH (mpawo taakwe kudooneka kuti asidi ya citric nchintu chigwisya pH). Kweelana abasyaazibwene ba Par, kugwisya mweelwe wa asidi ya citric mumusamu wa Hospira nchintu chizulide kuchita kuti asidi ya citric ibe mukati ka pH lowering agent njaamba Par. "Nokuba kuti ma molecule aa citric acid alakonzya kuba cibeela cha buffer system (Citric acid antoomwe a sodium citrate zilabelesyegwa antoomwe mbuli chintu chisumpula pH." (Nikuba kuti kuli kukazyania kulibonya, koyeeya kuti kutyola mulawu nchintu chesimpe. Federal Circuit iyoolanga-langa nchobakachita nkuta yamuchilawu mumulandu kuti bajane kulubizya kwa Hospira.) basyaazibwene tabazuminizyi abasyaazibwene ba Par mpawo bakasinizya (munzila iili kabotu) kuti ma molecule aa citric acid aali mumulongo teelede kubonwa kuti ngaacesya pH akuyungizya pH. Nokuba boobo, nkuta yamuchilawu yakakosola kuti Par wakazunda mulandu mpawo makanze aa Hospira alakonzya kutyola zyeelelo zya Par. Ooku kulomba kwakatobela.
Mubetesi Taranto wakasyoma kuti Federal Circuit yakasinizya kuti Mubetesi Dyke a Mubetesi Stoll abalo bakajanika kumuswaangano. Kulomba kwa Hospira kwakali kujatikizya kusala kwa nkuta yamuchilawu aatala azisinkilizyo zyotatwe. Nkuta Mpati ya Federal Circuit yakasaanguna kusinizya nzyaakajana Nkuta Mpati mumuzeezo wayo wakuti bunji bwa 9 mg/mL sodium chloride mumusamu wa Hospira bwakali mukati ka “aafwaafwi” 6-8 mg/mL mweelwe wakaambwa a Par. Kabunga kabasyaazibwene kakaamba kuti aawo notubelesya bbala lyakuti "aafwaafwi", "mutantamuke kubelesya minyinza yanamba iigaminide kuzintu zimwi," Cohesive Techs yakaamba. v. Water Corp., 543 F. 3d 1351 (Fed. Cir. 2008), kweendelana a Pall Corp. v. Micron Separations, Inc., 66 F. 3d 1211, 1217 (Fed. Cir. 1995). Kuzubulula majwi aa Monsanto Tech, eelyo "aatala" nacincwa muzipego, mweelwe wazipego ulakonzya kuyungizigwa kwiinda mweelwe kusikila muntu uuchibwene ulakonzya "kuyeeya kabotu" mweelwe uujatikizyidwe muzipego. LLC v. EI DuPont de Nemours & Co., 878 F.3d 1336, 1342 (Federal Court 2018). Muzyiimo ziliboobu, ikuti kakunyina naba omwe akati kabo uukulwaizya kuchesya bupati bwakulomba, kusala ooku kuyeeme azyeelelo zyakukamantana. Twaambo twachiimo eechi tubikkilizya naa nzila yakutyola mulawu ili "akati-akati" kuzwa kukukwabililwa (Conopco, Inc. v. May Dep't Stores Co., 46 F.3d 1556, 1562 (Federal Court, 1994). )) , Alimwi ino mbuti bupati bwakukwabililwa akaambo kakutalisya () . Nikuba kuti bakazumina kuti mulandu ooyu ulagwasya kukusala kwa nkuta aatala a kaambo aaka, Federal Circuit yakaamba kuti: "Kuti naa chibelesyo cha sikupegwa mulandu chilazuzikizya "chizuminano" chaamba muchiimo chimwi nchintu chamasimpe," v. US Int'l Trade Comm', 75 Federal 55, 1545, Nkuta Mpati (Federal Court). 1996). Aawa, kabunga kasyoma kuti nkuta yamuchilawu yakatambula kabotu zyeelelo zyaambwa aawa, mpawo kusala kwayo kweendelana abumboni bwabasyaazibwene. Nkuta Mpati yakaamba kuti basyaazibwene ba Par bakali basyaazibwene kwiinda basyaazibwene ba Hospira, ikapati kusikila mpobakasyoma "twaambo twabusongo, mbociyandika makanze aakukasya, akutabikkila maanu kwakulesya." Mukwiimpana, nkuta yamuchilawu yakaamba kuti basyaazibwene ba Hospira "tiibakachita buvwuntauzi bugwasya aatala aluzibo lwabusongo naakuti mulimo wachintu chakusandula manguzu." Kwiinda mutwaambo ootu, kabunga kabasyaazibwene tiibakajana kulubizya kulibonya pe.
Kujatikizya kulezya kwakubelesya zintu zipa kuti kube zintu ziyumu, Federal Circuit yakakaka kaambo ka Hospira kakuti nkuta yamuchilawu yakeelede kubikkila maanu kunzila yayo yoonse kutali zyeelelo zili mu ANDA. Kabunga kakajana kuti Nkuta Mpati yakabona kabotu asidi ya citric mbuli chintu chipa kuti nsimbi zichinche mbuli mbukwaambwa mumilandu, eezi zyeendelana abumboni bwabasyaazibwene bwabaabo boonse bobile. Kwiinda mubumboni bwakuti asidi ya citric ilabeleka mbuli chintu chipa kuti kube chelating, muzeezo ooyu ulakazya kaambo ka Hospira kakuti sitric acid tayelede kubelesegwa mbuli chelating agent. Kweelana a 35 USC§271(e)(2), zyeelelo zyakubeteka kutyola mulawu mumulandu wa ANDA nzintu zilembedwe mu ANDA (mbuli nkuta mboyakaamba, nkutyola mulawu kuyaka), kakwiindide Sunovion Pharm. , Inc. v. Teva Pharm. , USA, Inc., 731 F.3d 1271, 1279 (Federal Court, 2013). Kusyoma kwa Hospira mu ANDA yakwe ninzila ya ICH Q3D, eeyo iigwasyilizya mulandu wankuta yamuchilawu, kutali akaambo kakuti ooku kwaamba kwakayungizyigwa ku ANDA nikwakainda FDA niyakayanda "makani aambi" muchibaka eechi. ANDA tiiyakaumuna pe aatala apenzi eeli. Nkuta ya Federal Circuit yakajana kuti nkuta yamuchilawu yakalijisi bumboni buzulide bwakutondezya kuti majwi aa Hospira akali kweendelana akulesyegwa.
Kumamanino, kujatikizya bube bwa pH bwa citric acid azintu zikwabilila, Federal Circuit yakayeeme a Hospira mpawo tiiyakajisi nguzu zyakulomba aatala apenzi eeli. Mukuyungizya, Federal Circuit yakaiya kuti kabunga kakaamba kuti (zyomwe) zyaambwa mu '876 antoomwe a '657 "zitondezya ziimpene." Mbwaanga Nkuta Mpati tiiyakazya makani aaya (naakuti kuli busena bumbi), Nkuta Mpati yakaamba kuti Nkuta Mpati tiiyakasika kumamanino aasalala aakuti nzila ya Hospira yakatyola mulandu wakapandululwa (akati kazintu zimwi, eci) Zyeeme anzyobaamba bantu boonse munkuta). Zitondezyo) mpawo zisinizyigwe.
Par Pharmaceutical, Inc. v. Hospira, Inc. (Federal Circuit Court 2020) Kabunga: Mizeezo ya Circuit Judge Dyk, Taranto a Stoll, Circuit Judge Taranto
Kuliimya: Akaambo kakuti makani aaya mapya, makani aapegwa aawa alakonzya kutabeleka mubukkale boonse, alimwi kunyina ntaamu yeelede kutolwa kujatikizya makani aaya kakunyina lulayo lwamumulawo kweelana abukkale bumwi.
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