Older Patents Get Help As Federal Circuit Sides With Novartis In Gilenya, Everolimus Disputes
US court finds no obviousness-type double patenting under statute that changed patent term from 17 years from issuance to 20 years from filing; decisions will impact other cases involving patents issued prior to statute.
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A composition of matter patent for the Novartis MS drug Gilenya expires in 2019, but a recent inter partes review decision upheld a dosing patent that doesn't expire until 2027. However, analysts also touted the victory as a big win for Celgene and its competing S1P modulator ozanimod.
Agency’s recent approval of Enhertu, which has better response rate, sways some panel members to vote against Spectrum’s NSCLC drug. FDA’s Pazdur compares poziotinib’s dosing uncertainty to ‘building a house on quicksand.’
Leaders of FDA’s oncology center say sponsors could initiate a single randomized trial prior to receiving accelerated approval or conduct a single-group AA study concurrently with a randomized trial. FDA and sponsor could agree in advance on criteria for approval and withdrawal.