Pi kare malac, dano gubedo ka tamo ni kit ma ki yubu kwede twero ki pol kare bedo gin ma pire tek i lok ma mako twero me tic. Lok adaa ni tye gin ma oweko Federal Circuit omoko tam pa kot ma i gang kal i kom luyub yadi ma pe ki ngeyo i ngolo kop manyen pa District Pharmacopoeia i lok ma kwako Par Pharmaceutical, Inc. v. Hospira, Inc.. Turo cik pa Par ma ki yubu, bal ma nen maber bene obedo ki adwogi i kom adwogi ne.
Peko eni oa ki i kot pa ANDA, ma ngat ma okelo koko ni owaco ni Hospira's US Patent Nos. 9,119,876 ki 9,925,657 ma mako Par's Adrenalin® (adrenaline) ki kit me miiyo ne (injection). Hospira ocung pi pe turo cik ki bedo ma pe tiyo calo yoo me gwoke (kot me distrik oketo lok me gwoke i kom Hospira ki pi meno pe obolo koko i kot). Gin ma ki lwongo ni Par patent ni ki yubu me cobo peko ma onongo tye i kom jami macon ma ki yubu me kelo adrenaline. Pi yoo adek ma pat pat me balo ne (oxidation, racemization ki sulfonation), kare me gwoko ne nok. Lok me 1 me '876 patent tye ma nyutu:
Gin ma ki yubu ma tye ki: ma romo 0.5 onyo 1.5 mg/mL me epinephrine ki/onyo kadu ne, ma romo 6 onyo 8 mg/mL me gin ma gengo teko, ma romo 2.8 onyo 3.8 mg/mL me gin ma medo pH, ki antioxidant ma romo 0.1 onyo 1.1 mg/mL, gin ma dwoko piny pH nio wa 10.000. mL/mL ki ma romo 0.01 onyo 0.4 mg/mL mL me gin ma ki lwongo ni transition metal complexing agent, ma iye gin ma gengo two ni tye ki sodium bisulfite ki/onyo sodium metabisulfite.
(Tii ki coc ma nen maber i tam ni me nyutu cik ma mako lok pa Hospira). Iyonge gonyo cik magi, tam ni okati ki gonyo lok ni "gicikke" ma kot me distrik tiyo kwede pi cik acel acel. Jo ma gubedo i lok ni guye ni lok ni omyera obed ki tyen lok ma rwate, ma en aye "lok kom"; pi kot ma ki lwongo ni Federal Circuit Court of Appeals, Hospira pi omiyo lok mo ma mako lok meno.
Dul aryo ni weng gu miiyo lok ma ki ngeyo i kom cik adek ma malo ni. Ludiro pa Parr gu miyo caden ni kot otiiyo ki 9 mg/mL sodium chloride me moko bal ma tye i kin 6-8 mg/mL (Hospira ma tye i kin 6-8 mg/mL (Hospira ma tye, kadi bed ni tye ma piny ma romo 8.55 mg/mL bene kitiyo kwede) pien en romo cobo yub ma ki miito, ma en aye me "gwoko rwom me kwo pa cell i nge keto i lina remo." Ludiro pa Hospira gu kelo lok bot lutic luwote i kom ka ludiro ne ma ryek gi ye ni 9 mg/mL opoto i kin "ma romo" 6-8 mg/mL.
Ma lubbe ki peko ma tye i kom jami ma ki lwongo ni transition metal complexes, kot ma malo ni onyutu ni citric acid obedo gin ma ki ngeyo ni chelating agent ma lubu jami ma ki nongo. Hospira owaco i ANDA ni jami ma tye i kom jami ma pe rwate (jami) tye i kin cik me wilobo (tutwale ICH Q3D) cik). Ludiro pa Par gunyutu ni wat ma tye i kin gin ma ki yubu ki gin ma ki lwongo ni metal chelating agent ma ki waco i lok ni tye i kin ma mite. Ludiro pa Hospira dok pe gubedo ka pyem ki ludiro pa Par i kom lok, ento onyutu ni rwom ma malo me ICH Q3D onongo pe opore pi kot me dictrik. Ma ka meno, en tamo ni wel ma opore omyera ki kwany ki i Hospira's test batch, ma en tamo ni obi miito rwom ma lapiny pa citric acid ma calo chelating agent.
Dul aryo ni gitye ka pyem me tic ki gin ma dwoko piny pH ma ki lwongo ni Hospira's ANDA me nyutu dwong pa citric acid ma calo buffer (ki sodium citrate ne). I poto, citric acid kikome ki ngeyo ni medo pH (ki pe tye akalakala mo ni citric acid kikome obedo gin ma dwoko piny pH). Malube ki ludiro pa Par, kwanyo wel citric acid ma tye i Hospira formula romo weko citric acid ni poto i kin pH ma dwoko piny ma Par owaco. "Kadi wa jami ma ki lwongo ni citric acid molecules ni obi doko dul me buffer system (citric acid ki sodium citrate ma ki keto kacel ki tiyo kwede kacel macalo gin ma medo pH." (Kadi bed ni tye jami ma pe rwate, wi opo ni turo cik obedo lok ada. Federal Circuit obi neno tam pa kot ma malo i kot me nongo bal ma nen) ludiro pe giye ki ludiro pa Par ki gunyutu (ma opore) ni molecules me citric acid ma tye i yub ni pe omyera ki nen calo gin ma dwoko piny pH ki medo pH Ento, kot me distrik omoko ni Par oloyo lok ni ki tam pa Hospira ni obi turo twero pa Par me bedo ki twero me tic kwede.
Langol kop Taranto oye ni Federal Circuit omoko ni Langol kop Dyke ki Langol kop Stoll bene gubedo tye i rwate ni. Lok pa Hospira ni kwako tam pa kot ma malo i kom cik adek ni. Federal Circuit okwongo moko gin ma kot me District onongo i tam gi ni dwong pa 9 mg/mL sodium chloride i Hospira formulation ni opoto i kin "ma romo" 6-8 mg/mL ma Par owaco. Dul pa dano ma ryek ni owaco ni ka itye ka tic ki lok ni "cokcok", "kur tic ki namba ma kiketo pi jami ma ki moko," Cohesive Techs owaco. v. Water Corp., 543 F. 3d 1351 (Fed. Cir. 2008), ma jenge i kom Pall Corp. v. Micron Separations, Inc., 66 F. 3d 1211, 1217 (Fed. Cir. 1995). Ki lubo lok pa Monsanto Tech, ka "about" ki loko i lok ma ki waco, wel ma ki waco ni ki twero medo ne ma kato wel ma ngat ma tye ki ngec ni obi "tamo maber" i kom lok ma ki waco ni. LLC v. EI DuPont de Nemours & Co., 878 F.3d 1336, 1342 (Kot madit 2018). I lok ma kit meno, ka ngat mo pe tye ka cwako dwoko piny rwom me koko, moko tam ni cung i kom rwom me ribbe. Jami ma tye i rwom man tye iye ka ce gin ma ki waco ni tye ka turo cik ni tye "ma rwate" ki i rwom me gwok (Conopco, Inc. v. May Dep't Stores Co., 46 F.3d 1556, 1562 (Federal Court, 1994). )) , ki kit ma rwom me gwok ni pire tek kwede pi yub me yubu ne (pe) Kadi bed ni giye ni lok ma kidoto ni tye me konyo tam pa kot i kom lok man, Federal Circuit owaco ni: "Ka ce jami pa ngat ma kidoto ni rwate ki "gicikke" ma rwate i te jami mogo obedo lok ma mako lok adaa," v. US Int'l Trade Comm', 75 Federal 35, 1545, Kot Federal. 1996). Kany, dul ni tamo ni kot ma malo ni otiimo gin ma ki waco kany, ki tam gi ni jenge i kom lok pa dano ma ngeyo lok ni. Kot me distrik omoko ni ludiro pa Par onongo gitye ki ngec madwong loyo ludiro pa Hospira, tutwalle kit ma onongo jenge i kom “lok ada, kit ma pire tek kwede me keto cik meno, ki kit ma cik meno pe pire tek kwede.” Ka i poro, kot ma malo owaco ni ludiro pa Hospira "pe gutimo kwed ma rwate i kom rwom me tic pa gin ma ki lwongo ni tonicity modifier." Malube ki lok magi, dul pa ludiro ni pe gunongo bal mo ma nen.
Ma mako peko pa jami ma ki lwongo ni transition metal complexing agents, Federal Circuit okwero lok pa Hospira ni kot me district onongo myero oket cwinye i kom cik ma ki yubu me tic kwede ma ka keto tam ne i kom cik ma tye i ANDA. Lukiko ni onongo ni kot ma malo ni omoko ni citric acid calo gin ma kelo alokaloka i kom jami ma ki waco i lok ma ki waco ni, ma rwate ki lok pa ludiro pa jo aryo ni. Malube ki lok ma ki waco ni citric acid tiyo calo chelating agent, neno man kwero lok pa Hospira ni citric acid pe ki yubu me tic kwede calo chelating agent. Malube ki 35 USC§271(e)(2), rwom me moko tam i kom turo cik i kot me ANDA tye gin ma ki waco i ANDA (kit ma kot owaco kwede, obedo turo cik ma kelo dongo), kun loko i kom Sunovion Pharm. , Inc. v. Teva Pharm. , USA, Inc., 731 F.3d 1271, 1279 (Kot madit, 2013). Kit ma Hospira jenge kwede i kom ANDA ne tye ICH Q3D standard, ma miiyo kony bot kot me distrik, pi pien ni ki medo lok man i ANDA inge FDA mito "ngec mukene" i kom lok man. ANDA pe obedo mot i kom lok man. Federal Circuit onongo ni kot ma malo ni tye ki jami ma oromo me nyutu ni lok pa Hospira ni rwate ki cik ma ki keto ni.
Me agiki ne, malube ki rwom me pH pa citric acid ki jami ma gwoko ne, Federal Circuit ocung i kom lok pa Hospira ki pe ogwoko twero me lok i kom lok man. Medo ikom meno, Federal Circuit opwonyo ni dul ni omoko ni (gin acel) ma ki waco i '876 ki '657 patents "nyutu ni tye gin ma pat." Kit ma kot madit pe okwero lok man (onyo kabedo mukene), kot madit owaco ni kot madit pe oo i agiki ma nen ka maleng ni yub pa Hospira ni oturo lok ma ki waco ni (i kin jami mukene, man) cung i kom lok ma kot owaco bot lwak). Jami ma ki waco) ki ki moko ne.
Par Pharmaceutical, Inc. v. Hospira, Inc. (Federal Circuit Court 2020) Panel: Tam pa Circuit Judge Dyk, Taranto ki Stoll, Circuit Judge Taranto
Lagam: Pi kit ma lok man tye kwede, ngec ma kimiyo kany pe twero tic i kom jami ducu, dok pe myero kitim gin mo i kom ngec man labongo nongo tam me cik ma lubbe ki jami mogo ma tye.
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