FTC Steps Into FDA’s ‘Ministerial’ Gap, Seeks Delisting Of REMS Patent
Jazz’s REMS patent appears to cover only a method of distributing Xyrem not a method of using the drug and if so should be delisted from FDA’s Orange Book, FTC argues in Jazz infringement suit against Avadel, which had itself sued FDA seeking release from patent certification requirement.
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Jazz’s REMS patent on distribution of Xyrem does not belong in the Orange Book because it is directed to systems rather than a method of using the drug, court rules, agreeing with FTC’s analysis.
Avadel challenges FDA requirement that it submit patent certification, asks court to direct the agency to issue final approval of its narcolepsy drug Lymryz. Having often criticized the use of REMS to delay competition, FDA now finds itself defending an Orange Book listing.
The Federal Trade Commission supports a limit of one 30-month stay of approval on generic drugs in patent litigation