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 transcript and slides, preliminary clinical safety review data, the briefing booklet and the proposed distribution system. These materials are collectively referred to as the ACA materials.

Amneal Pharmaceuticals petitioned for inter partes review (IPR) of Jazz’s patents based on the ACA materials. The threshold issue before the PTAB was whether the ACA materials were publicly accessible and whether one of ordinary skill in the art, exercising reasonable diligence, would have been able to locate them. The PTAB found that the ACA materials were publicly accessible on the FDA website listed in the Notice more than two months prior to the critical date of the Jazz patents. The PTAB also found that a pharmacist, aware that Xyrem’s active ingredient (γ-hydroxybutyrate) could potentially be abused as a “date-rape drug,” would have had sufficient motivation to locate the FDA Notice and the ACA website. The PTAB held that the ACA materials were prior art to Jazz’s patents, and found the challenged claims obvious. Jazz appealed.

The Federal Circuit affirmed the PTAB’s decision, finding that the ACA materials were publicly accessible to a pharmacist or a computer scientist. The Court found that announcement of the ACA meeting was widely disseminated through a Notice in the Federal Register, that the meeting was open to the public, that the ACA materials on the website were accessible via the link, and that the Notice provided specific instructions on how to access those materials. The Court rejected Jazz’s argument that the ACA materials needed to be indexed or searchable to constitute a printed publication, finding that accessibility was sufficient to establish that the materials qualified as printed publications. The Court also found that since the ACA materials were posted on a public domain source, there was no reasonable expectation that a user would not copy or distribute the ACA materials. The Court therefore held that the ACA materials were “in the possession of the public” and constituted prior art.

The Federal Circuit found no error in the PTAB’s claim interpretation and held that the record supported the finding that Jazz’s patented risk management system for tracking prescriptions was obvious. The Court agreed that implementing the ACA materials’ centralized database system on multiple computers, a feature taught in another prior art reference, would have been a predictable use of a known distributed data system according to its established function.