'Teva Has Earned Nothing,' US FDA Tells Court In Battle Over Generic Restasis 180-Day Exclusivity
Court orders agency to provide 48 hours' notice before issuing decision that would allow any manufacturer other than Teva to launch a generic.
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US court tosses Teva suit seeking generic Restasis exclusivity. FTC loses appeal challenging Shire's citizen petitions, settles Solvay pay-for-delay case. DoJ resolves FCA case alleging company made deal to avoid paying FDA user fees for two NDAs.
Complaint challenges agency's revised definition of "first applicant," which does not require notice of Paragraph IV certification to obtain exclusivity.
Restasis Patent Review Back On Track As Federal Circuit Quashes Mohawk Tribe's Sovereign Immunity Claim
Appeals court says inter partes review is more like an agency enforcement action than a civil suit and thus tribal immunity does not apply to the proceeding; PTAB now to determine patentability of Restasis patents.