Patent Regulation Drops Deference To ANDA, 505(b)(2) Sponsors
FDA's final rule implementing provisions of Medicare Modernization Act ‘will fuel litigation,’ attorney predicts.
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PhRMA is concerned about the agency giving deference to generic sponsors in patent use code disputes, while GPhA wants a mechanism to challenge refuse-to-receive letters.
Industry has 90 days to comment on FDA’s current handling of generic challenges to brand protections.
Appeals court says FDA violated Hatch-Waxman by awarding 180-day exclusivity solely to Teva based on reissued patent; celecoxib generics are already marketed but could step out from Pfizer-authorized status.