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'Teva Has Earned Nothing,' US FDA Tells Court In Battle Over Generic Restasis 180-Day Exclusivity

Executive Summary

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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Legal News: Teva V. FDA, Pay-For-Delay, Citizen Petitions, User Fee Scheme

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.

Teva Sues US FDA To Obtain 180-Day Exclusivity For Its Generic Restasis

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.

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