On July 13, 2018, in Jazz Pharms., Inc. v. Amneal Pharms., LLC, (Case Nos. 2017-1617, -1673, -1674, -1675, -1676, -1677, -2075), the Federal Circuit affirmed the Patent Trial and Appeal Board’s (“PTAB”) holding that certain FDA advisory meeting minutes, transcripts, and slides were publicly available such that the materials constituted prior art. We have previously discussed the PTAB’s public availability jurisprudence in Coalition for Affordable Drugs VIII, LLC v. The Trustees of the University of Pennsylvania, IPR2015-01835 where the PTAB held a presentation given to investors was not prior art. In this instance, the Federal Circuit affirmed the PTAB’s holding of public availability because the materials were available on a website, the Federal Register provided a link to the materials, the materials were available on the internet two months before the critical date, and there was no reasonable expectation of confidentiality.
During the regulatory review process for one of Jazz’s sensitive drugs, the FDA announced an advisory committee meeting in a Federal Register Notice. Id. at 3. The Federal Register Notice provided a link where the background materials were posted before the meeting, and the meeting minutes, transcript and slides would be posted following the meeting (collectively the Advisory Committee Art or “ACA materials”). Id. at 3-4. Amneal Pharmaceuticals, LLC (“Amneal”) petitioned for inter partes review of patents held by Jazz Pharmaceuticals, Inc. (”Jazz”), related to a system for tracking prescriptions of “sensitive drugs.” Id.at 2-3. The primary issue discussed by the Federal Circuit was whether the ACA materials were “sufficiently accessible to the public to constitute prior art.” Id. at 4.
The Federal Circuit affirmed the PTAB decision finding that the ACA materials were publicly accessible to skilled artisans. The Federal Circuit, relying on In re Klopfenstein, 380 F.3d 1345, 1350 (Fed. Cir. 2004), noted that “whether a reference is a ‘printed publication’ is a ‘case-by-case inquiry into the facts and circumstances surrounding the reference’s disclosure to members of the public’” and reviewed the relevant Klopfenstein factors. Id. at 13. The Court noted that the meeting was open to public and the Federal Register provided a hyperlink to the background materials prior to the meeting as well as to the meeting minutes, transcript, and slides following the meeting. Id. at 14. Moreover, the Court noted, instructions on how to access the website materials were provided and the ACA materials were available on the public FDA website at least two months before the critical date of the patents, with no expectation of confidentiality. Id.
The Court further rejected Jazz’s argument that the materials were not publicly available because they were not indexed. Id. at 19. The Court stated that it has “consistently held that indexing or searchability is unnecessary for a reference to be a printed publication,” and regardless “the Federal Register was meaningfully indexed.” Id. at 19-20. The Court was also unpersuaded by Jazz’s argument that skilled artisans would have been “incapable of finding the Notice.” Id. at 21. The Court stated that “’if accessibility is proved, there is no requirement to show that particular members of the public actually received the information.” Id. at 21 (internal citations omitted).
In sum, the decision provides additional guidance to practitioners as to the PTAB’s and Federal Circuit’s application of the Klopfenstein factors in determining public availability for prior art purposes.