1. Pink Sheet

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

 
• By Brenda Sandburg

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.

Delist
Court rules Jazz's Xyrem patent should be delisted from FDA's Orange Book • Source: Shutterstock

A district court judge’s decision that Jazz Pharmaceuticals plc’s Risk Evaluation and Mitigation Strategy (REMS) patent does not cover a method of using Xyrem (sodium oxybate) provides some clarity on what patents may be listed in the US Food and Drug Administration’s Orange Book and could limit the REMS distribution system patents that brand manufacturers can list.

Judge Gregory Williams of the US District Court for the District of Delaware agreed with Avadel Pharmaceuticals plc that Jazz’s patent claims are directed to systems and not methods of using the drug and

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