Mō te wā roa, kua whakapono te iwi ka taea e te hanganga o ngā kereme te whai wāhi nui ki ngā tautohenga pateni, ā, he maha ngā wā ka whai wāhi nui tēnei. Ko tēnei kōrero pono te pūtake mō te Kaunihera ā-Motu ki te whakaū i te whakataunga a te Kōti ā-Rohe ki te kaihanga rongoā whānui i roto i te whakataunga hou o te Pharmacopoeia ā-Rohe i roto i te keehi Par Pharmaceutical, Inc. v. Hospira, Inc. I pāngia hoki ngā hua e te takahi i te tauira pateni a Par, ngā paerewa hapa mārama.
I puta mai ēnei raruraru i roto i te whakawakanga ANDA, i reira i kereme ai te kaiwhakapae i ngā Nama Patene US a Hospira 9,119,876 me 9,925,657 e pā ana ki te Adrenalin® (adrenaline) a Par me tana tikanga whakahaere (werohanga). I tautoko a Hospira i te kore takahi me te kore mana hei parepare (i tukuna e te kooti rohe he parepare ki a Hospira, nō reira kāore i piira). Ko te patene Par e aro ana ki tētahi hanganga e wikitoria ana i ngā ngoikoretanga o ngā hanganga adrenaline o mua. Nā te mea e toru ngā ara whakahekenga rerekē (te waikura, te racemization me te sulfonation), he poto te roa o tōna oranga. Ko te Kereme 1 o te patene '876 e tohu ana:
He hanganga kei roto i ēnei: ​​tata ki te 0.5 ki te 1.5 mg/mL o te epinephrine me/ranei tōna tote, tata ki te 6 ki te 8 mg/mL o te kaiwhakahaere tonicity, tata ki te 2.8 ki te 3.8 mg/mL o te kaihoko whakanui pH, me te antioxidant tata ki te 0.1 ki te 1.1 mg/mL, te kaihoko whakaiti pH 0.001 ki te 0.010 mL/mL me te tata ki te 0.01 ki te 0.4 mg/mL mL o te kaihoko whakahiato konganuku whakawhiti, kei roto i te antioxidant te konutai bisulfite me/ranei te konutai metabisulfite.
(Whakamahia te tuhinga matotoru i roto i te whakaaro hei tohu i ngā here e pā ana ki te piira a Hospira). Whai muri i te whakamāramatanga o ēnei here, i whakaarohia e te whakaaro he whakamaoritanga o te kupu "kawenata" i whakamahia e te kooti takiwa mō ia here. I whakaae mārama ngā rōpū me whai tikanga noa te kupu, arā, "mō"; mō te Kooti Pīra Porowhita ā-Motu, kāore a Hospira i whakarato i tētahi whakamārama e rerekē ana.
I tukuna e ngā taha e rua ngā taunakitanga a ngā tohunga mō ngā here e toru i runga ake nei. I whakaatu ngā tohunga a Parr i whakamahia e te kooti te 9 mg/mL konutai pūhaumāota hei whakatau i te takahi i te awhe o te 6-8 mg/mL (te kukū o Hospira, ahakoa e whakamahia ana hoki ngā kukū iti iho i te 8.55 mg/mL) nā te mea he rawaka hei whakatutuki i te kaupapa i whakaarohia, arā, ko te "pupuri i te pono o ngā pūtau ora i muri i te werohanga o te adrenaline ki roto i te toto." I whakahē noa ngā tohunga a Hospira ki ōna hoa mahi mēnā i whakapono āna tohunga hangarau mohio kei roto te 9 mg/mL i te awhe "tata" 6-8 mg/mL.
Mō ngā herenga o ngā matatini whakarewa whakawhiti, i whakamātauhia e te kooti ā-rohe he matū chelating te waikawa citric e mōhiotia ana i runga i ngā taunakitanga. I kī a Hospira i roto i tana ANDA kei roto i ngā paerewa o te ao (ina koa ko ngā Aratohu ICH Q3D) te ihirangi o ngā poke huānga (ngā konganuku). I whakamātauhia e ngā tohunga a Par kei roto i te awhe e hiahiatia ana te whanaungatanga e rite ana i waenga i te hua paerewa me te kukū o te matū chelating konganuku i whakahuatia i roto i ngā kereme. Kāore anō ngā tohunga a Hospira i whakataetae ki ngā tohunga whānui a Par, engari i whakamātauhia ko te rohe o runga o te paerewa ICH Q3D he paerewa kāore i te tika mō te kooti ā-rohe. Engari, e whakapono ana ia me tango te nui e tika ana mai i te puranga whakamātautau a Hospira, e whakapono ana ia ka hiahiatia he iti ake ngā taumata o te waikawa citric hei matū chelating.
Kei te whakataetae ngā rōpū e rua ki te whakamahi i te kaihoko whakaheke pH a Hospira, arā, te ANDA, hei tohu i te kukū o te waikawa citric hei ārai (me tōna konutai citrate). I te mara, e kiia ana ko te waikawa citric tonu te mea hei whakanui i te pH (ā, kāore e kore ko te waikawa citric tonu te kaihoko whakaheke pH). E ai ki ngā tohunga a Par, mā te tango i te nui o te waikawa citric i roto i te tātai Hospira ka nui hei hanga i te waikawa citric kia taka ki roto i te awhe o te kaihoko whakaheke pH i kīia e Par. "Ahakoa aua ngota waikawa citric ka uru ki te pūnaha ārai (ka whakamahia ngātahitia te waikawa Citric me te sodium citrate hei kaiwhakaara pH." (Ahakoa he maha ngā whakahē, kia mahara he mea pono te takahi ture. Ka arotakehia e te Federal Circuit te whakataunga pono a te kooti rohe i roto i te whakawakanga. Kia tae atu ai ki tētahi hapa mārama.) Kāore ngā tohunga o Hospira i whakaae ki ngā tohunga o Par, ā, i whakaatu (i runga i te whakaaro tika) kāore ngā ngota waikawa citric i roto i te hanganga e tika ana kia kiia he whakaheke pH, he whakanui pH hoki. Heoi, i whakatau te kooti rohe i toa a Par i te keehi, ā, ka takahia e te tono a Hospira ngā mana pateni a Par. I whai mai tēnei piira.
I whakapono a Kaiwhakawā Taranto i whakaū te Tari Whakawā ā-Motu i tae atu hoki a Kaiwhakawā Dyke rāua ko Kaiwhakawā Stoll ki te hui. I uru te piira a Hospira ki te whakatau a te kooti rohe mō ia o ngā here e toru. I whakaū tuatahi te Tari Whakawā ā-Motu i ngā kitenga a te Kooti Rohe i roto i tana whakaaro ko te kukū o te 9 mg/mL konutai pūhaumāota i roto i te hanganga Hospira i taka ki roto i te rohe "tata" 6-8 mg/mL i kīia e te Par. I tohu te rōpū tohunga ina whakamahia te kupu "tata", "kaua e whakamahi i ngā rohe tau tino pakari mō ngā tawhā kua tohua," te kōrero a Cohesive Techs. v. Water Corp., 543 F. 3d 1351 (Fed. Cir. 2008), i runga i a Pall Corp. v. Micron Separations, Inc., 66 F. 3d 1211, 1217 (Fed. Cir. 1995). E whakahua ana i te kōrero a Monsanto Tech, ina whakarerekētia te kupu "mō" i roto i ngā kereme, ka taea te whakawhānui i te whānuitanga tau e keremehia ana ki tua atu i te whānuitanga kia "whakaarohia e te tangata pūkenga" te whānuitanga e hipokina ana e te kereme. LLC v. EI DuPont de Nemours & Co., 878 F.3d 1336, 1342 (Te Kōti Matua 2018). I roto i ēnei take, ki te kore tetahi o ngā rōpū e tautoko ana i te whakaiti i te whānuitanga o te kereme, ka ahu mai te whakatau i te paerewa whakakotahitanga. Kei roto i ngā huānga o tēnei paerewa mēnā he "waenga" te tauira takahi ture i te whānuitanga tiaki (Conopco, Inc. v. May Dep't Stores Co., 46 F.3d 1556, 1562 (Te Kōti Matua, 1994). )) , Ā, me pēhea te hiranga o te whānuitanga tiaki mō te kaupapa o te whakawhāiti (ehara i te mea hou o nāianei) tonu. Ahakoa te whakaae he takoha te kereme ki te whakatau a te kooti mō tēnei take, i tohu te Kōti Matua: "Mēnā ka tutuki te whakaaro a te tangata whakapae i tētahi tikanga "kawenata" whaitake i raro i ētahi āhuatanga, he take hangarau tēnei," v. US Int'l Trade Comm', 75 F.3d 1545, 1554 (Kōti Matua, 1996). I konei, e whakapono ana te rōpū kua tangohia e te kooti rohe te tauira i whakaahuatia i konei, ā, ko tana whakatau i ahu mai i ngā taunakitanga a ngā tohunga. I whakatau te Kōti Rohe he nui ake te whakapono o ngā tohunga a Par i ngā tohunga a Hospira, inā koa i te mea i whakawhirinaki ki "ngā meka hangarau, te hiranga o te kaupapa o te here, me te kore arohaehae o te here." He rerekē, i whakatau te kooti rohe kāore ngā tohunga a Hospira "i mahi i tētahi tātaritanga whai tikanga o te papamuri hangarau, o te mahi rānei o te whakarerekētanga tonicity i kīia." I runga i ēnei meka, kāore i kitea e te rōpū tohunga he hapa kitea.
Mō ngā herenga o ngā matū whakaranu whakarewa whakawhiti, i whakakahoretia e te Tari Porowhita ā-Motu te tautohe a Hospira me aro te kooti ā-rohe ki tāna tauira whānui kua whakaarohia, kaua ki ngā whakaritenga i roto i tāna ANDA. E kitea ana e te Rōpū he tika te whakaaro o te Kooti ā-Rohe ki te waikawa citric hei matū whakaranu whakarewa whakawhiti kua whakaahuatia i roto i ngā kereme, he rite tonu ki ngā taunakitanga a ngā tohunga e rua. I runga i te taunakitanga e mahi ana te waikawa citric hei matū whakaranu, ka whakakahoretia e tēnei tirohanga te tautohe a Hospira kāore te waikawa citric i te whakaarohia kia whakamahia hei matū whakaranu. E ai ki te 35 USC§271(e)(2), ko te paerewa mō te whakatau i te takahi i roto i ngā tautohe ANDA ko ngā ihirangi kua whakaahuatia i roto i te ANDA (e ai ki te kooti, ​​he takahi hanganga), e whakahua ana i a Sunovion Pharm., Inc. v. Teva Pharm., USA, Inc., 731 F.3d 1271, 1279 (Kooti ā-Motu, 2013). Ko te paerewa ICH Q3D te mea e whakawhirinaki ana a Hospira ki tana ANDA, e tautoko ana i te whakataunga a te kooti rohe, ehara i te mea nā te mea i tāpirihia tēnei tohutoro ki te ANDA i muri i te tono a te FDA i ngā "mōhiohio rerekē" mō tēnei wāhanga. Kāore a ANDA i noho puku mō tēnei take. I kitea e te Tari Porowhita ā-Motu he nui ngā taunakitanga a te kooti rohe hei whakaatu i te tutuki katoa o te kōrero a Hospira i te here.
Hei whakamutunga, mō ngā āhuatanga pH-awe o te waikawa citric me ōna pūhui, i ahu mai te Federal Circuit i te kereme a Hospira, ā, kāore i rāhuitia te mana ki te kereme mō tēnei take. Hei tāpiri, i kitea e te Federal Circuit e kī ana te rōpū ko ngā whakatakotoranga (taurite) o ngā pateni '876 me '657 "e tohu kaha ana i te ritenga kē." Nā te mea kāore te Kōti Matua i whakahē i tēnei kereme (me tētahi atu wāhi rānei), i kī te Kōti Matua kāore te Kōti Takiwā i tae ki tētahi whakatau mārama ko te whakatakotoranga a Hospira i takahi i te kereme kua whakamāramatia (me ētahi atu mea, ko tēnei) Kei runga i ngā ihirangi tūmatanui o te kōti). Ngā whakatakotoranga) me te whakaū.
Par Pharmaceutical, Inc. v. Hospira, Inc. (Te Kōti Porowhita ā-Motu 2020) Paewhiri: Ngā Whakaaro o te Kaiwhakawā Porowhita Dyk, Taranto me Stoll, Kaiwhakawā Porowhita Taranto
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