Surprise patent turnaround threatens Gilenya exclusivity

22 June 2022
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Earlier-than-expected US competition for Gilenya (fingolimod) in relapsing remitting multiple sclerosis (RRMS) could be on the way, after a patent litigation decision went against developer Novartis (NOVN: VX).

A fresh hearing at the US Court of Appeals for the Federal Circuit reversed an earlier ruling, finding this time that a patent related to the blockbuster MS drug was in fact invalid.

Chinese drugmaker HEC Pharma (HKG: 1558) wants to make a generic version, and is the only company left pursuing legal routes, after Novartis agreed with other litigants on a timetable for copycat competition.

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