Jazz Pharms., Inc. v. Amneal Pharms., Inc., — F.3d —, 2018 U.S. App. LEXIS 19268 (Fed. Cir. 2018)
The patented invention at issue in Jazz Pharms is not a drug or drug treatment, but rather to a “drug distribution system for tracking prescriptions” for drugs with a risk of abuse The PTAB found claims from all six patents to be invalid as obvious.
The core issue on appeal was whether a pre-filing disclosure by Jazz counted as a prior art “printed publication.”
Printed Publication: As the language suggests, a “printed publication” must be both “printed” and also a “publication.” These requirements though have been broadly construed. “Printed” publications go well beyond physical hard-copies to allow for various media – including video and online forms. To be a “publication,” the reference needs to be made sufficiently available to the public – publication. In the leading case of In re Hall, the Federal Circuit explained that accessibility to the relevant public is key – we ask “whether interested members of the relevant public could obtain the information if they wanted to.” Although the court has developed a number of guide posts, the question of sufficient availability is seen as a factual inquiry handled on a case-by-case basis.Continue Reading ...