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FTC Steps Into FDA’s ‘Ministerial’ Gap, Seeks Delisting Of REMS Patent

 
• By Brenda Sandburg

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.

Orange patent
FTC files brief in suit over listing of patents in FDA's Orange Book • Source: Shutterstock

The US Federal Trade Commission suggests that Jazz Pharmaceuticals plc improperly listed its patent on a system for distributing Xyrem (sodium oxybate) in the US Food and Drug Administration’s “Orange Book” because the patent does not claim the drug itself or a method of using it.

The FTC filed an amicus brief in Jazz’s infringement suit against Avadel Pharmaceuticals plc in the US District Court for the District of Delaware saying that if the patent covers only a distribution system under a Risk Evaluation and Mitigation Strategy (REMS) program it should be delisted

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