Delisting Of Jazz’s Xyrem Patent In Orange Book Could Spur More Infringement Counterclaims
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
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.
Sanofi Improperly Listed Lantus Patent In FDA's Orange Book, Appeals Court Finds
First Circuit reverses dismissal of direct purchasers' suit alleging improper listing of patent on device drive mechanism delayed competition; district court to decide if this constitutes antitrust violation.