Bristol Myers Squibb amanga Xspray Pharma chifukwa chophwanya malamulo okhudza mankhwala a khansa ya m'magazi

Wodandaula Bristol Myers Squibb Company (BMS) adapereka mlandu motsutsana ndi wotsutsa Xspray Pharma AB ku New Jersey County Lachitatu. Mlandu wophwanya malamulo a patent ukufuna kuletsa Otsutsa kupanga ndi kugulitsa mitundu yodziwika bwino ya mankhwala a Sprycel a Wodandaula.
Sprycel cholinga chake ndi kuchiza akuluakulu ndi ana omwe apezeka ndi mitundu yosiyanasiyana ya khansa ya m'magazi. Odandaula ali ndi ma patent awiri, patent ya '725 ndi patent ya '103 (patent in suit), yotchedwa "Njira zokonzekera 2-aminothiazole-5-aromatic carboxamides ngati kinase inhibitors." Ma patentwa adaperekedwa mu 2009 ndi 2014 motsatana. Kuwonjezera pa patent yomwe ikukambidwa, odandaulawo alinso ndi pulogalamu yatsopano ya mankhwala (NDA) ya mankhwala omwa.
Malinga ndi madandaulo, Xspray yapereka pangano losaulula ku FDA momwe amapempha chilolezo chopanga ndikugulitsa mtundu wa Sprycel wamba. Pakati pa zinthu zina, Xspray idalumikizana ndi odandaulawo ndikuwadziwitsa kuti zomwe zikukambidwa patent zinali zosavomerezeka kapena sizinaphwanyidwe ndi zinthu zamtsogolo za otsutsawo.
Kalata ya Xspray yopita kwa odandaula inawapatsa mwayi wopeza chinsinsi cha mbali zina za Xspray NDA, koma sinapatse odandaula mwayi wopeza fayilo yayikulu ya mankhwala osokoneza bongo. Odandaula alibe mwayi wopeza mafayilo akuluakulu a mankhwala osokoneza bongo, zomwe zimawalepheretsa "kuwunikiranso zambiri zokhudzana ndi kusanthula kwawo kuphwanya malamulo," akutero madandaulowo.
Madandaulo akuti Xspray ikuphwanya pempho limodzi la ma patent aliwonse omwe akukambidwa. Kuphatikiza apo, Otsutsa akufotokoza kuti Otsutsa adalengeza cholinga chawo chopanga ndikugulitsa zinthu zawo za NDA nthawi yomweyo atavomerezedwa ndi FDA, zomwe Otsutsawo akunena kuti zingakhale kuphwanya malamulo ena a ma patent omwe atchulidwa pamwambapa.
BMS inanena kuti ngati otsutsawo sanaletsedwe kuphwanya malamulo a patent omwe akukambidwa, "adzavutika kwambiri komanso osakonzedwanso". Madandaulowo akuwonetsa milandu iwiri yophwanya malamulo a patent. Otsutsawo akufuna chigamulo chabwino pa mlandu uliwonse, lamulo loletsa kuphwanya malamulo ena, lamulo loonetsetsa kuti zinthu za NDA za otsutsawo zisapangidwe patent yomwe ikukambidwayo isanathe, ndalama zothandizira ngati otsutsawo alengeza zinthu zawo za NDA, ndi zina zambiri.