In Genzyme Therapeutic Products Limited v. Biomarin Pharmaceutical, Inc., [2015-1720, 2015-1721](June 14, 2016), the Federal Circuit affirmed the PTAB’s decisions in IPR2013-00534 and IPR2013-00537 that certain claims of  U.S. Patent No. 7,351,410 and U.S. Patent No. 7,655,226 were invalid for obviousness.

Genzyme’s APA challenged the result under the Administrative Procedures Act because the Board cited references in its final written decisions that were not specifically included in the combinations of prior art on which the Board instituted review. The Federal Circuit was unmoved, explaining that the introduction of new evidence in the course of the trial is to be expected in Inter Partes Review trial proceedings and, as long as the opposing party is given notice of the evidence and an opportunity to respond to it, the introduction of such evidence is perfectly permissible under the APA.

The Federal Circuit said that Genzyme’s argument reflected a misunderstanding of the role of the institution decision in Inter Partes Review proceedings before the Board. There is no requirement, either in the Board’s regulations, in the APA, or as a matter of due process, for the institution decision to anticipate and set forth every legal or factual issue that might arise in the course of the trial. The critical question for compliance with the APA and due process is whether Genzyme received “adequate notice of the issues that would be considered, and ultimately resolved, at that hearing.” Ultimately the Federal Circuit blamed Genzyme for not either moving to exclude the added references or seeking leave to file a surreply.

The Federal Circuit held in Ariosa that the Board may consider a prior art reference to show the state of the art at the time of the invention, regardless of whether that reference was cited in the Board’s institution decision, and that is how the Board used the contested references.