FDA Xyrem Meeting Materials Qualify As Printed Publication

In Jazz Pharmaceuticals, Inc. v. Amneal Pharmaceuticals, LLC, the Federal Circuit affirmed decisions of the Patent Trial and Appeal Board (PTAB) that invalidated seven Orange Book-listed patents for Xyrem®. The main issue on appeal was whether FDA meeting materials available on a web page published in a Federal Register Notice qualified as a "printed publication" under 35 USC § 102. The Federal Circuit agreed with the PTAB that they did.

The Xyrem® Patents At Issue

Xyrem® is approved for the treatment of symptoms associated with narcolepsy, but its active ingredient (gamma-hydroxybutyrate) also is known as the "date-rape drug." As noted in the Federal Circuit decision, "[b]ecause of its potential for abuse, the FDA approved Xyrem® under 'restricted distribution regulations ... to assure safe use of the product." The seven Jazz' patents at issue (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) relate to methods of