On July 13, 2018, the Federal Circuit decided Jazz
Pharmaceuticals, Inc. v. Amneal Pharmaceuticals, LLC (Fed.
Cir. Jul. 13, 2018), an appeal of six inter partes review decisions
by the Patent Trial and Appeal Board's (PTAB) finding that
certain claims of seven patents (U.S. Patent Nos. 7,668,730;
7,765,106; 7,765,107; 7,895,059; 8,589,182; 8,457,988; and
8,731,963) covering a computerized risk-management system for the
narcolepsy drug Xyrem were invalid as obvious in light of prior
art.
Xyrem, marketed by Jazz Pharmaceuticals, Inc. (Jazz), treats
daytime sleepiness and muscle weakness in narcolepsy patients.
Xyrem's active ingredient has the potential for abuse as a date
rape drug; therefore, the Food and Drug Administration (FDA) only
allows restricted distribution of the drug. Because of this abuse
potential, during the review process for Xyrem, FDA scheduled an
advisory committee meeting to discuss risk management-related
issues. A Federal Register Notice, dated
