Muchuchisi Bristol Myers Squibb Company (BMS) akamhan'arira muchuchisi Xspray Pharma AB muNew Jersey County neChitatu. Nyaya yekutyora kodzero dzemunhu inovavarira kudzivirira Vachuchisi kugadzira nekutengesa mishonga yeSprycel inogadzirwa nemuchuchisi.
Sprycel yakagadzirirwa kurapa vakuru nevana vakaonekwa vaine mhando dzakasiyana dzeleukemia. Vapomeri vane mapatent maviri, patent ye'725 uye patent ye'103 (patent in suit), ine musoro unoti "Nzira dzekugadzira 2-aminothiazole-5-aromatic carboxamides se kinase inhibitors." Mapatent aya akabudiswa muna 2009 na2014 zvichiteerana. Kuwedzera patent iri kutaurwa nezvayo, vanopomera vanewo application itsva yemushonga (NDA) wemushonga unonwiwa.
Sekureva kwenyunyuto, Xspray yakaendesa chibvumirano chekusaburitsa pachena kuFDA umo vanotsvaga mvumo yekugadzira nekutengesa Sprycel. Pakati pezvimwe zvinhu, Xspray yakataura nevamhan'ari ndokuvaudza kuti zvichemo zvepatent zvaikakavadzana zvaive zvisina basa kana kuti hazvina kutyorwa nezvigadzirwa zvemangwana zvevanopomerwa.
Tsamba yeXspray yakanyorerwa vamhan'ari yakavapa mukana wekuwana zvakavanzika zvimwe zvikamu zveXspray NDA, asi haina kupa vamhan'ari mukana wekuwana faira guru remishonga. Vamhan'ari havana mukana wekuwana mafaira makuru emishonga, izvo zvinovatadzisa "kukwanisa kwavo kuongorora ruzivo rwakakosha pakuongorora kwavo kutyorwa kwemitemo," inodaro nyaya yacho.
Chichemo ichi chinoti Xspray inotyora chikumbiro chimwe chete chepatenti imwe neimwe iri kutaurwa nezvayo. Pamusoro pezvo, Vapomeri vanotsanangura kuti Vapomeri vakazivisa chinangwa chavo chekugadzira nekutengesa zvigadzirwa zvavo zveNDA mushure mekubvumidzwa neFDA, izvo Vapomeri vanoti zvaizove zvakare kutyora mapatent ataurwa pamusoro apa.
BMS yakati kana vapomeri vakasadzivirirwa kuramba vachityora mitemo yepamutemo iri kutaurwa nezvayo, vaizotambura "nekukuvara kukuru uye kusingagadzirisiki". Chichemo ichi chinotaura mhosva mbiri dzekutyora mitemo yepamutemo. Vapomeri vari kutsvaga sarudzo yakanaka pamhosva imwe neimwe, murairo wekudzivirira kutyorwa kwemitemo yepamutemo, murairo wekuona kuti zvigadzirwa zveNDA zvevapomeri hazvizogadzirwe patent iri kutaurwa nezvayo isati yapera, rubatsiro rwemari kana vapomeri vakashambadza zvigadzirwa zvavo zveNDA, nezvimwewo.
Nguva yekutumira: Kubvumbi-12-2023