PTAB / Obviousness

Obviousness prior art: From many comes one?

Published July 29, 2016

On July 27, 2016, the PTAB issued five written decisions finding all claims of six patents assigned to Jazz Pharmaceuticals Inc. unpatentable. Each of the patents related to tracking and controlling the distribution of sensitive prescription drugs that have the potential to be abused, misused, or diverted.

An interesting aspect of these decisions is the collective treatment of four exhibits that were discussed together at an FDA Advisory Committee Meeting. The meeting involved a review of the safety of Jazz’s narcolepsy drug Xyrem®. Xyrem® contains gamma hydroxyl butyrate (“GHB”), which has been widely reported for its abuses as a “club drug” or “date rape” drug. Thus, part of the FDA review process for Xyrem® involved discussion of how to limit this potential for abuse. The four prior art exhibits, collectively referred to as the “Advisory Committee Art” or “ACA,” were:

  • an Advisory Committee Meeting transcript and presentation slides
  • a preclinical safety review
  • a briefing booklet
  • a video and transcript

Although each was a separate exhibit, the petitioner (in its IPR petitions) and the Board (in its decisions) generally treated the four exhibits as a single disclosure for the obviousness inquiry. The Board appeared to justify this unitary treatment by noting the close relationship of the exhibits:

“We agree with Petitioner’s analysis and determine that a POSA would have had ample motivation to combine the ACA documents, which were prepared at the same time, relate to the same drug product and the same restricted distribution system, were discussed together at the same Xyrem Advisory Committee Meeting, and were made available via file links from a single FDA web page.”

–IPR2015-00546, Final Written Decision (July 27, 2016), p. 40.

Treating closely related exhibits as a single collection for obviousness has its advantages. For example, you may need to only establish a motivation to combine once. Once linked together, all may be fair game within the collective disclosure.

Tread cautiously, however, if the relationship of the exhibits isn’t that close or the exhibits don’t seamlessly merge into a single collection. Establishing motivation to combine multiple references generally may not be sufficient to establish the motivation to combine specific features in those references. And if the collective disclosure of the related references does not specifically address a claimed feature, it may present a counter-argument: if it would have been obvious to add this feature, why wasn’t it done with the product or method discussed in the related references?

IPR decisions: IPR2015-00545 (8,589,182);  IPR2015-00546 (7,765,106); IPR2015-00547 (7,765,107); IPR2015-00548 (7,895,059); IPR2015-00551 and IPR2015-00554 (8,457,988 and 7,668,730)


Posted on 07/29/2016 by Deakin T. Lauer