JAZZ PHARMACEUTICALS, INC. v. AMNEAL PHARMACEUTICALS, LLC
Federal Circuit Summary
Before Newman, Lourie, and Reyna. Appeal from the Patent Trial and Appeal Board.
Summary: References were sufficiently accessible to the public to constitute printed publication prior art even if they were not searchable or indexed because the materials were located on a publicly available website, specific instructions on how to access the materials were provided, the materials were available for at least two months before the critical date of the patents at issue, and there was no reasonable expectation that the materials would remain confidential.
Amneal Pharmaceuticals, LLC (“Amneal”) requested Inter Partes Review of several patents owned by Jazz Pharmaceuticals, Inc. (“Jazz”). The patents at issue are directed to a drug distribution system for tracking sensitive drug prescriptions. An FDA advisory committee meeting on risk management issues associated with one of Jazz’s sensitive drugs was announced in a Federal Register Notice. The Notice included a hyperlink to the FDA website where meeting minutes, transcripts, slides and other materials were posted. Jazz argued that these materials were not sufficiently accessible to the public to constitute prior art. The PTAB disagreed and determined that the materials were publicly accessible because a person of ordinary skill in the art would have been familiar with the Federal Register, motivated to look for notices related to drug distribution, safety, or abuse prevention, and capable of locating the notice and the materials. The Board determined that certain claims in Jazz’s patents at issue were obvious and relied on the materials on the FDA website as prior art. Jazz appealed.
The Federal Circuit affirmed the Board’s decision. The Federal Circuit found that the materials were publicly accessible to persons of ordinary skill in the art. The FDA announced the meeting through a Notice in the Federal Register. The meeting was open to the public. The Notice included a hyperlink to the FDA website where materials were posted before the meeting and the meeting minutes, transcripts, and slides were posted after the meeting. The Notice provided specific instructions on how to access the meeting materials on the website. Further, the materials were available on the website for at least two months before the critical date of the patents at issue, and the materials were distributed via public domain sources so there was no expectation that the materials would remain confidential. Jazz argued that the materials were not indexed or searchable. However, indexing or searchability is not always necessary for a reference to qualify as a printed publication under 102(b). Moreover, the Federal Circuit found that the Federal Register is indexed. Additionally, the Federal Circuit found that the Board did not need to find that specific persons actually received or examined the materials. The Federal Circuit held that substantial evidence supported the Board’s finding that the materials were publicly accessible to persons of ordinary skill in the art exercising reasonable diligence before the critical date of the patents in suit, and therefore qualified as printed publications under 102(b).
This case is: JAZZ PHARMACEUTICALS, INC. v. AMNEAL PHARMACEUTICALS, LLC
Edited by: Paul Stewart
Written by: Noorean I. Gill and Nicole R.Townes