Jazz v. Amneal: When your FDA Submissions are Prior Art

On July 13, 2018, the Federal Circuit decided Jazz Pharmaceuticals, Inc. v. Amneal Pharmaceuticals, LLC, affirming the Patent Trial and Appeal Board (PTAB)’s finding of invalidity of certain claims of seven Orange Book-listed patents for Xyrem®. 

The 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) each relate to tracking the distribution of gamma-hydroxy butyrate (GHB, marketed as Xyrem®), which can be abused as a “date rape drug.”  Given its potential for abuse, the FDA held an Advisory Committee (“AC”) meeting to address possible restrictions on the distribution of Xyrem®. Prior to the filing of the patents, notice of the meeting was published in the Federal Register, which included a hyperlink where materials from the meeting, including slides and transcripts of the meeting, were later posted.  Importantly, the AC materials were available at the linked site prior to the critical date for each Orange Book-listed patent. 

Amneal filed petitions for inter partes review of Jazz’s seven aforementioned patents, alleging that the patents were invalid in view of the hyperlinked AC meeting materials.  Jazz responded that the AC materials did not qualify as a “printed publication” under 35 U.S.C. § 102(b), and therefore, were not prior art. The PTAB disagreed, finding that certain claims of Jazz’s patents were invalid in view of the AC materials. 

Jazz appealed to the Federal Circuit, arguing that the PTAB erred “by equating the constructive notice provided by the Federal Register with the law governing public accessibility of prior art,” and that the AC materials were not indexed and not searchable. The Court disagreed, explaining that a “printed publication” is one that “has been disseminated or otherwise made available to the extent that persons interested and ordinarily skilled in the subject matter or art, exercising reasonable diligence, can locate it.”  See Opinion at page 12.  Here, the Court determined that prior to the critical date: (1) the Federal Register notice provided express instructions regarding where and how to access the AC materials; (2) one skilled in the art would have been familiar with the Federal Register and motivated to look for notices such as this one; and (3) the method of distribution provided no expectation that the AC materials would remain confidential.  The Court also noted that searchability and/or indexing were not legally required for a reference to constitute a “printed publication.”  The Court also recognized that previous decisions regarding “printed publications” related to materials disclosed at scientific conferences, not materials disclosed during meetings with a federal agency, but declined to set forth a bright line rule regarding such materials. 

This decision is a reminder of the importance of reviewing materials related to potential patent filings prior to any possible public disclosure, including submissions to the FDA.

Written by:  Caleb A. Bates, Ph.D.