Pi kare malac, dhanu ubedo ku yioyic nia kit ma jukwanu kudu lembe copo man pol kare bedu piny ma pire tek i lembe mi patent. Lembe maeni ubedo the lembe ma Federal Circuit umiyu ni ketho lembe ma kot madit ungolo ikum ju ma yiku yath ma rwinyo i ngolo lembe manyen pa District Pharmacopoeia i Par Pharmaceutical, Inc. v. Hospira, Inc. case. Turo cik pa Par's patented formula, lembe ma rac ma nen kamaleng de ubedu ku adwogi ikum adwogi.
Peko eni utimiri i lembe pa ANDA, ma jatel wi lembe ne ukwayu Hospira's US Patent Nos. 9,119,876 man 9,925,657 ikum Par's Adrenalin® (adrenaline) man yore mi miye (injection). Hospira ukwayu nia kud ju turo cik man ju ma timo ngo tic calu yore mi gwoko (kot madit mi adhura uketho lembe ikum Hospira man kumeno edaru ngo timo appeal). Par patent utiye pi yubu piny ma jwigo peko pa yath macon mi adrenaline. Ni lembe adek matung tung mi nyothre (oxidation, racemization man sulfonation), kwo pare utiye nyanok. Lembe mir acel mi '876 patent utiye lanyuth:
Jam piny ma juketho i iye: 0.5 ku 1.5 mg/mL pa epinephrine man/nyoke kadu pare, 6 ku 8 mg/mL pa tonicity regulator, 2.8 ku 3.8 mg/mL pa pH raising agent, man antioxidant ma romo 0.1 ku 1.1 mg/mL, piny ma dwoko piny pH ni 0.10.000. mL/mL man 0.01 ku 0.4 mg/mL mL pa transition metal complexing agent, ma antioxidant uketho i iye sodium bisulfite man/nyo sodium metabisulfite.
(Ti ku boldface i paru peri ni nyuthu cik ma juketho ikum kwac pa Hospira). I ngei gonyo cik eni, paru ne uketho gonyo the lembe mi "cik" ma kot mi adhura tiyo kudu pi cik acel acel. Ju ma timo lembe eca giyio nia wec ne ucikere ni bedu ku the lembe ma pire tek, ma en e "i kum"; pi Federal Circuit Court of Appeals, Hospira umio ngo the lembe ma tung tung.
Ju ario zoo gi miyo lanyuth pa jururieko ikum cik adek ma malu eni. Ju ma gingeyo lembe pa Parr giwacu nia kot utiyo ku 9 mg/mL sodium chloride pi nyang ikum turo cik ikind 6-8 mg/mL (Hospira concentration, kadi bed ni concentrations ma piny 8.55 mg/mL de jutiyo kudu) kum etiye piny ma romo pi timo lembe ma juyike, ma en e “gwoko leng pa cell i ngei ketho i lina rimo." Ju ma gingeyo lembe pa Hospira gi ketho lembe ikum juwadi ikum ka ju ma gingeyo tic pare giyio nia 9 mg/mL upodhu ikind "ma romo" 6-8 mg/mL.
I kum peko pa transition metal complexes, kot mi adhura unyutho nia citric acid ubedo chelating agent ma julwongo ni chelating agent malubiri ku lembe ma jukoro. Hospira uwacu i ANDA pare nia piny ma nyai (metals) utiye ikind cik mi ng'om zoo (mandha ICH Q3D) Guidelines). Ju ma gingeyo lembe pa Par ginyutho nia wat ma rwate ikind piny ma jutiyo kudu man piny ma jutiyo kudu ma julwongo ni metal chelating agent ma juweco pire i lembe ma jukwanu utiye ikind piny ma juyenyo. Ju ma gingeyo lembe pa Hospira kendo gi rwinyo ngo ku ju ma gingeyo lembe pa Par, ento enyutho nia rwom ma malu pa ICH Q3D ubedo rwom ma ber ungo pi kot madit. Ento, en eyiyu niya wel ma mitire umaku juwodh kud i Hospira's test batch, ma en eyiyu niya bi mito rwom ma piny pa citric acid calu chelating agent.
Ju aryo eni gibe pyem pi tic ku piny ma dwoko piny pH pa Hospira's ANDA ni nyuthu kadhiri pa citric acid calu buffer (man sodium citrate pare). I ng'om, citric acid en gire jukwanu ni medo pH (man epe ku jiji nia citric acid en gire utiye piny ma dwoko piny pH). Ni lubre ku ju ma gingeyo lembe pa Par, kwanyo wel pa citric acid i formula pa Hospira romo mi ketho citric acid upodhu i rwom pa piny ma dwoko piny pH ma Par uwacu. "Kadi citric acid molecules marom eno de bibedo thenge mi buffer system (Citric acid man sodium citrate ma jutiyo kudu karacelu calu pH raising agent." (Kadi bende lembe ma tung tung utiye, poi nia turo cik utiye lemandha. Federal Circuit bi neno wi lembe ma kot madit mi pokolembe ungolo pi nwangu lembe ma rac pa Hospira.) ju ma gingeyo lembe gi kwero lembe pa ju ma gingeyo lembe pa Par man gi nyutho (ma ber) nia citric acid molecules ma nwang i formula ne ucikere ngo ni nen calu pH-lowering man pH-increasing Ento, kot madit ungolo nia Par uloyo kesi ne man paru pa Hospira bi turo twero pa Par. Appeal eni ulubo.
Japoklembe Taranto uyio nia Federal Circuit uyio nia Japoklembe Dyke ku Japoklembe Stoll de gibino i rombo ne. Lembe pa Hospira uketho i iye yub pa kot madit ikum cik adek acel acel. Federal Circuit ugam uketho lembe ma kot madit unwangu i paru pare nia dwong pa 9 mg/mL sodium chloride i Hospira formulation ubedo i kind "ma romo" 6-8 mg/mL ma Par uwacu. Udul pa ju ma gingeyo lembe onyuthu nia ka jutiyo ku wec ma ewacu ni "aromo", "juko tiyo ku namba ma tek pi lembe moko," Cohesive Techs uwacu. v. Water Corp., 543 F. 3d 1351 (Fed. Cir. 2008), malubiri ku Pall Corp. v. Micron Separations, Inc., 66 F. 3d 1211, 1217 (Fed. Cir. 1995). Ni lubre ku lembe pa Monsanto Tech, ka “about” juloko i lembe ma jukwanu, wel ma jukwanu copo bedu ma kadho wel ma jukwanu ni ngati ma ngeyo tic copo “paru maber” ikum lembe ma jukwanu. LLC v. EI DuPont de Nemours & Co., 878 F.3d 1336, 1342 (Federal Court 2018). I lembe ma kumeno, ka ngati acel de mbe ma ukwayu jwigo piny ma jukwanu, yub ne ucungo iwi cik mi dikiri. Thek ma juketho i cik eni uketho i iye ka nyo lembe ma juwacu nia eturo cik utiye "ma rwinyo" kud i rwom mi gwoko (Conopco, Inc. v. May Dep't Stores Co., 46 F.3d 1556, 1562 (Federal Court, 1994). )) , Man kite ma rwom mi gwoko ubedo tek kudu pi yub mi nyuthu () ngo. Kadok nwango yio nia lembe ma jukwanu ubedo kony pa kot ikum lembe eni, Federal Circuit onyuthu kumae: "Ka jam tic pa jatel wi lembe eca urombo ku "cik" ma rwate i thenge moko utiye lembe mi lembe ma jutimo," v. US Int'l Trade Comm', 75 Federal 33, 1555, 1545 (Federal Court. 1996). Kae, judongo eca giyio nia kot mi adhura ujolo lembe ma jukoro keni, man yub migi ucungo iwi lembe ma ju ma gingeyo lembe giyero. Od bura madit ungolo nia ju ma gingeyo lembe pa Par gibedo ku yioyic ma sagu ju ma gingeyo lembe pa Hospira, asaga ikum lembe ma gicungo iwi "lembe ma pire tek, beru pa the lembe ma juketho i cik, man bedo ma pire tek ungo pa cik." I ayi pa tung tung, kot mi adhura ugam ungolo nia ju ma gingeyo lembe pa Hospira "gitimo ngo sayusac maber ikum lembe ma jutimo nyo tic pa tonicity modifier." Ni lubre ku lembe eni, ju ma gingeyo lembe eca ginwangu ngo lembe moko marac.
I kum peko pa transition metal complexing agents, Federal Circuit ukwero lembe pa Hospira ma ewacu niya kot madit ucikere ni ketho cwinye ikum formula pare ma juyiko ento ungo ikum cik ma juketho i ANDA pare. Jurucik eca ginwangu niya kot madit ungiyo citric acid calu piny ma nyayu aloka loka ma juloko i lembe ma jukwanu, ma rwate ku lembe ma ju ma ngeyo lembe ario zoo giwacu. Ni lubre ku lembe ma jukoro nia citric acid timo tic calu chelating agent, paru eni kwetu lembe pa Hospira nia citric acid juyike ngo ni tic calu chelating agent. Ni lubre ku 35 USC§271(e)(2), cik ma juketho pi turo cik i lembe pa ANDA utiye lembe ma jukoro i ANDA (calu ma kot unyutho, etiye turo cik ma ber), ma lubo Sunovion Pharm. , Inc. v. Teva Pharm. , USA, Inc., 731 F.3d 1271, 1279 (Federal Court, 2013). Gen pa Hospira ikum ANDA pare ubedo ICH Q3D standard, ma cwaku lembe pa kot madit, kadi nang epe pi lembe eni jumedo i ANDA ingey FDA upenjo "lembe mange" ikum lembe eni. ANDA ubedo ling ikum lembe eni. Federal Circuit unwangu niya kot mi adhura utiye ku giranyutha ma romo nyutho nia lembe pa Hospira urombo ku cik ma juketho.
Mi thum, ikum pH-influencing properties pa citric acid man buffers pare, Federal Circuit ucungo iwi lembe pa Hospira man eweko ngo twero mi wacu ikum lembe eni. Mi medo, Federal Circuit ung'eyo nia judongo eca giwacu nia (rom) lembe ma jukoro i '876 ku '657 patents "nyuthu lembe ma tung tung." Calu ma kot madit ungolo ngo lembe eni (nyo kabedo mange), kot madit ungolo nia kot madit ungolo ngo ikum lembe ma Hospira uketho ikum lembe ma jukoro (ikind piny mukende, eni) Ecungo ikum lembe ma dhanu ceke uwacu i kot). Lembe ma jukoro) man jubi yio.
Par Pharmaceutical, Inc. v. Hospira, Inc. (Federal Circuit Court 2020) Panel: Paru pa Circuit Judge Dyk, Taranto man Stoll, Circuit Judge Taranto
Lembe mi poyo wic: Ni lembe ma nyen maeni, lembe ma jumiyo kany copo bedu ngo pi lembe ceke, man lembe moko ope ma umitu jutim ikum lembe eni manangu jumiyo ngo kony pa cik malubiri ku lembe moko.
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