Jazz Pharmaceuticals, Inc. v. Amneal Pharmaceuticals, LLC., Nos. 2017-1671, 2017-1673, 2017-1674, 2017-1675, 2017-1676, 2017-1677, and 2017-2075 (Fed. Cir. July 13, 2018)

This was an appeal from a final decision of the Patent Trial and Appeal Board (PTAB) finding patent claims relating to a drug distribution system for a “sensitive drug” invalid as obvious. A key issue on appeal was whether certain meeting materials relied upon by the petitioner, and ultimately the PTAB, were printed publications.

The documents at issue concerned a public meeting held by the U.S. Food and Drug Administration (FDA) to discuss risk management issues related to a drug called Xyrem® – a narcolepsy treatment, which could be abused as a “date-rape drug.” Those documents included background materials for the meeting, meeting minutes, a transcript, and slides. The meeting was announced in the Federal Register. That announcement also included a hyperlink to an FDA website where these documents could be found. 

The patent owner contended that because the Federal Register is lengthy, the record had insufficient evidence that a person skilled in the art could have found the documents. The Federal Circuit examined several factors en route to rejecting this argument. 

First, the Federal Circuit explained that because the Federal Register notice had been widely disseminated, indexing was not required. But, even if indexing was required, the court observed that the Federal Register is indexed in a way that a person of ordinary skill in the art could have found the notice. Next, the record showed that the materials were available online “for a substantial time before the critical date” of the challenged patents. Third, there was no expectation that these public materials would be kept confidential. The Federal Circuit made clear that publication in the Federal Register does not create a per se rule that referenced materials are publicly accessible; instead, the facts must be weighed consistent with precedent to determine if materials are printed publications under the statute.

A copy of the opinion can be found here