PTAB may make decisions based on new evidence in IPR proceedings

Genzyme Therapeutic Products v. Biomarin Pharmaceutical, Nos. 2015-1720 and 2015-1721(Fed. Cir. June 14, 2016)

The patentee appealed two inter partes review (IPR) decisions of the Patent Trial and Appeal Board (PTAB), arguing that by relying on facts and legal arguments that were not set forth in the institution decision, the PTAB violated the Administrative Procedure Act’s (APA’s) requirements of notice and denied the patentee due process by not providing an opportunity to respond.

The Federal Circuit rejected the patentee’s argument. It held that the PTAB did not “change theories in midstream,” much less deny the patentee notice of any such change, since the PTAB’s final written decisions—that found the claims at issue unpatentable—were based on the same combinations of references that were set forth in its institution decisions. As such, the patentee could not argue that it lacked notice of the specific combinations of references that the PTAB relied upon in finding the claims invalid. 

The Federal Circuit also rejected the patentee’s argument that the institution decision must refer to every bit of evidence that is relied upon by the PTAB in its final written decision. The court decided that there is no requirement, either in the PTAB regulations or in the APA, or even as a matter of due process, for the institution to anticipate and set forth every legal or factual issue that might arise in the course of the trial.

The Federal Circuit noted that the critical question for compliance with the APA and due process was whether the patentee received “adequate notice of the issues that would be considered, and ultimately resolved, at that hearing.” The PTAB’s final written decision cited two prior art references as evidence of the state of the art at the time of the patentee’s invention, but the patentee had notice of these references. Further, the patentee had not shown that the PTAB’s decision rested on any factual or legal issues as to which the patentee was denied notice or an opportunity to be heard at a meaningful point in the proceedings. The court also stated that instead of a due process challenge, the patentee should have either filed a motion to exclude the references or leave to submit a further substantive response.

A copy of the opinion can be found here ►