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Delisting Of Jazz’s Xyrem Patent In Orange Book Could Spur More Infringement Counterclaims

Executive Summary

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.

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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.

Drug Safety Patent Fight: Avadel Sues US FDA Over Interpretation Of Xyrem REMS Patent Use Code

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