Ummangali iBristol Myers Squibb Company (BMS) ufake isimangalo nxamnye nommangalelwa iXspray Pharma AB eNew Jersey County ngoLwesithathu. Esi simangalo sokwaphulwa kwelungelo lomenzi sijonge ukuthintela abamangalelwa ekwenzeni nasekuthengiseni iinguqulelo eziqhelekileyo zeziyobisi zoMmangali iSprycel.
I-Sprycel yenzelwe ukunyanga abantu abadala nabantwana abafunyaniswe beneentlobo ezahlukeneyo ze-leukemia. Abamangali baneepatenti ezimbini, ipatenti ka-'725 kunye nepatenti ka-'103 (ipatenti ekwisuti), enesihloko esithi “Iindlela zokulungiselela ii-carboxamides ze-2-aminothiazole-5-aromatic njenge-kinase inhibitors.” Iipatenti zakhutshwa ngo-2009 nango-2014 ngokulandelelana. Ukongeza kwipatenti ekuthethwa ngayo, abamangali bakwanokusetyenziswa kweyeza elitsha (NDA) leyeza eliselwayo.
Ngokwesikhalazo, i-Xspray ingenise isivumelwano sokungatyhilwa kwi-FDA apho bafuna imvume yokwenza nokuthengisa uhlobo oluqhelekileyo lweSprycel. Phakathi kwezinye izinto, i-Xspray iqhagamshelane nabamangali yaza yabaxelela ukuba amabango elungelo lomenzi aphikiswayo ayengasebenzi okanye ayephulwa ziimveliso zabamangalelwa zexesha elizayo.
Ileta ye-Xspray eya kubamangali yabanika ukufikelela okuyimfihlo kwiindawo ezithile ze-Xspray NDA, kodwa ayizange inike abamangali ukufikelela kwifayile ephambili yeziyobisi. Abamangali abanalo ukufikelela kwiifayile eziphambili zeziyobisi, nto leyo ethintela "amandla abo okuphonononga ulwazi oluhambelana nohlalutyo lwabo lokwaphulwa kwemithetho," sitsho isikhalazo.
Isikhalazo sithi iXspray iyaphula ubuncinane ibango elinye leepatenti ezichaphazelekayo. Ukongeza, abaMangali bachaza ukuba abaMangali babhengeze injongo yabo yokwenza nokuthengisa iimveliso zabo ze-NDA kwangoko emva kokuvunywa yi-FDA, nto leyo abaMangali bathi iya kuba kukwaphulwa ngakumbi kweepatenti ezikhankanyiweyo apha ngasentla.
I-BMS yathi ukuba abamangalelwa abathintelwanga ekwaphuleni amalungelo obunikazi akuthethwa ngawo, baya kufumana “umonakalo omkhulu nongenakulungiswa”. Esi sikhalazo sidwelisa amatyala amabini okwaphulwa kwamalungelo obunikazi. Abamangali bafuna isigqibo esifanelekileyo kwityala ngalinye, umyalelo wokuthintela ukwaphulwa kwamalungelo obunikazi, umyalelo oqinisekisa ukuba iimveliso ze-NDA zabamangalelwa aziyi kuveliswa ngaphambi kokuba ilungelo lobunikazi elithethwayo liphelelwe lixesha, uncedo lwemali ukuba abamangalelwa bathengisa iimveliso zabo ze-NDA, nokunye.
Ixesha lokuthumela: Epreli-12-2023