Bristol Myers Squibb yareze Xspray Pharma kubera kutubahiriza uburenganzira bw'ipatanti ku muti wa kanseri y'amaraso

Ku wa gatatu, ikigo cy’urega Bristol Myers Squibb Company (BMS) cyareze uregwa Xspray Pharma AB mu ntara ya New Jersey. Ikirego cyo kutubahiriza uburenganzira bw’abaregwa kigamije kubuza abaregwa gukora no kugurisha ubwoko rusange bw’umuti w’urega Sprycel.
Sprycel igenewe kuvura abantu bakuru n'abana barwaye ubwoko butandukanye bwa kanseri y'amaraso. Abarega bafite patenti ebyiri, patenti ya '725 na patenti ya '103 (patenti iri mu kirego), yitwa "Uburyo bwo gutegura 2-aminothiazole-5-aromatic carboxamides nk'imiti ibuza kinase." Patenti zatanzwe mu 2009 na 2014. Uretse patenti iri mu kirego, abarega banafite imiti mishya (NDA) ku muti unyobwa.
Nk’uko ikirego kibivuga, Xspray yatanze amasezerano yo kudatangaza amakuru kuri FDA aho basaba uburenganzira bwo gukora no kwamamaza verisiyo rusange ya Sprycel. Mu bindi, Xspray yavuganye n’abarega ibamenyesha ko ibirego bya patenti bivuguruzanya bitagifite agaciro cyangwa bitabangamiye ibicuruzwa by’abaregwa mu gihe kizaza.
Ibaruwa ya Xspray yandikiwe abarega yabahaye uburenganzira bwo kugera mu ibanga ku bice bimwe na bimwe bya Xspray NDA, ariko ntiyahaye abarega uburenganzira bwo kugera ku dosiye nyamukuru y’ibiyobyabwenge. Abarega ntibafite uburenganzira bwo kugera ku madosiye y’ibiyobyabwenge, ibi bikaba bibangamira "ubushobozi bwabo bwo gusuzuma amakuru ajyanye n’isesengura ryabo ry’ibyaha," nk'uko ikirego kibivuga.
Ikirego kivuga ko Xspray itubahirije nibura ikirego kimwe cya buri patenti ivugwa. Byongeye kandi, abarega basobanura ko abaregwa batangaje ko bashaka gukora no kwamamaza ibicuruzwa byabo bya NDA nyuma yo kwemezwa na FDA, ibyo abarega bavuga ko byaba ari ukwica andi ma patenti yavuzwe haruguru.
BMS yavuze ko abaregwa nibadakumirwa gukomeza kurenga ku ruhushya rw’ipatanti zivugwa, bazagira "ingaruka zikomeye kandi zidashobora gukosorwa". Ikirego kivuga ku byaha bibiri byo kurenga ku ruhushya rw’ipatanti. Abarega barasaba umwanzuro mwiza kuri buri kirego, itegeko ryo gukumira ko hazabaho kurenga ku ruhushya, itegeko ryemeza ko ibicuruzwa bya NDA by’abaregwa bitazakorwa mbere yuko patenti ivugwa irangira, ikiguzi cy’amafaranga abaregwa nibamamaza ibicuruzwa byabo bya NDA, n'ibindi.