Federal Register Notice Paves the Way to Public Availability
In Jazz Pharm. Inc. v. Amneal Pharm. LLC, the Fed. Cir. affirmed the PTAB's conclusion of obviousness. Notice in the Federal Register of an FDA public meeting coupled with a hyperlink to background materials posted by the drug sponsor and the FDA, prior to the critical date was sufficient to conclude broad dissemination of the background material, to interested persons of ordinary skill. Also relevant to the determination of public availability was the duration of availability and distribution without an expectation of confidentiality. Patentee's argument as to a lack of evidence of searchability and indexing was rejected in view of the breadth of dissemination.