The Federal Circuit upheld a PTAB decision in which meeting materials published on the FDA website and linked to in a notice in the Federal Register (“Notice”) were sufficiently accessible to constitute “printed publication” prior art in Jazz Pharm. Inc. v Amneal Pharm. LLC, No. 2017-1671, 2018 WL 3400764 (Fed. Cir. July 13, 2018). The meeting materials were from an FDA Advisory Committee meeting concerning a proposed risk management system for tracking abuse of Jazz’s anti-narcolepsy medication, Xyrem. Xyrem contains an active ingredient with potential to be abused as a “date-rape drug.” The meeting materials (“ACA materials”), consisted of minutes, transcripts, slides, and other background materials.
Jazz owns several patents directed to a drug distribution system for “sensitive drugs” consisting of a centralized database to track prescriptions and provide reports for pharmacists and physicians. In 2016, Amneal Pharmaceuticals LLC (“Amneal”) petitioned for IPRs of seven of Jazz’s patents. The PTAB instituted review for all challenged claims of six of the patents, and partial review for the seventh.
Amneal relied in part on the ACA materials to argue obviousness in support of their petitions. Jazz responded that the website address buried in the non-searchable, non-indexed, 67,702-page Notice linking to the ACA materials on the FDA website was not sufficiently accessible to the public to constitute prior art. The Board disagreed, however, finding that a person of ordinary skill in the art would have been familiar with the Federal Register, sufficiently motivated to check the Notice, and capable of locating the ACA materials. The Board relied on these materials to invalidate the instituted claims.
Jazz appealed the decisions. The Federal Circuit concluded the Board correctly held that the ACA materials qualified as printed publication prior art. Despite holding that the Notice need not be indexed or searchable to qualify as a printed publication, the Court went on to find that the materials were, in fact, “meaningfully indexed.” Furthermore, the Court found that the ACA materials were widely disseminated because the FDA advisory meeting was open to the public and announced via the Notice, which contained a hyperlink to the ACA materials and specific instruction on how to access them on the FDA website. As a result, the Federal Circuit affirmed the PTAB’s decision.
In reaching its decision, the Court identified a number of factors that ANDA litigants should focus on when seeking to qualify non-traditional literature as printed publications. These include the extent of dissemination, the intended audience of the materials, the length of time over which the materials were available before the critical date, and expectations by the patent holder that the materials would remain confidential or inaccessible to the public.
Thanks to Nick Sieger, law student at the University of Notre Dame Law School, for his contributions to this post.