GSK Paxil Hemihydrate Patent Claim Invalid, Court Says In Ruling For Apotex
This article was originally published in The Pink Sheet Daily
SmithKline’s early clinical trials on the safety and efficacy of paroxetine hemihydrate as an antidepressant did not constitute an “experimental use” of the claimed invention, the court says.
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Paroxetine patent was “inherently anticipated” by an earlier patent, court says. Appellate panel changes its reasoning from an earlier opinion, in which it said the patent was invalidated by the “public use” bar. Revised language means Zyprexa patent challengers cannot cite the case in arguing olanzapine clinical trials constituted prior public use.
With inspectors no longer out in the field, they have more time to wrap up work on previously completed facility evaluations, attorney Howard Sklamberg says; inspections freeze could delay manufacturers’ abilities to bring facilities into compliance following adverse inspection findings, as well as agency reclassifications of facility status.