Addressing public accessibility of prior art, the US Court of
Appeals for the Federal Circuit affirmed a Patent Trial and Appeal
Board (PTAB) obviousness decision, finding that widely disseminated
materials available on the US Food and Drug Administration (FDA)
website were publicly accessible to a pharmacist exercising
reasonable diligence, and thus constituted a "printed
publication." Jazz Pharmaceuticals, Inc. v. Amneal
Pharmaceuticals, LLC, Case Nos. 17-1671, -1673, -1675, -1676,
-1677, -2075 (Fed. Cir. July 13, 2018) (Lourie, J).
Jazz Pharmaceuticals owns several patents relating to a drug
distribution system for tracking prescriptions of sensitive drugs
such as Xyrem®. During the regulatory review
process, the FDA published a Notice in the Federal
Register about an advisory committee meeting and provided a
hyperlink to its website where information relating to Xyrem's
approval would be posted. The FDA subsequently posted Xyrem's
materials, such as the meeting
