In a recent decision affirming the PTAB’s obviousness findings in an IPR, the Federal Circuit confirmed that the Board may use prior art not cited in instituted grounds as evidence to support a final decision. Genzyme Therapeutic Prod. Ltd. P’ship v. Biomarin Pharm. Inc., No. 2015-1721 (Fed. Cir. June 14, 2016).
In two IPR petitions, Biomarin challenged all claims of two Genzyme patents as being invalid for obviousness on multiple grounds. The Board instituted review of both patents on two grounds each and ultimately found all claims for both patents invalid as obvious in its final written decision.
To support the conclusion of obviousness, the Board used two pieces of prior art not cited in the instituted grounds to illustrate the state of the art. Genzyme appealed the decision, claiming that the Board violated the notice and opportunity to respond requirements of the Administrative Procedure Act (APA) because it relied on evidence not set forth in the instituted grounds.
On appeal, the Federal Circuit upheld the Board’s obviousness finding. In its IPR reply brief, Biomarin had presented the prior art in question as evidence to rebut one of Genzyme’s arguments of nonobviousness. The Court found that Genzyme had actual notice of this evidence because Genzyme presented arguments on the record against the use of Biomarin’s prior art as a basis for obviousness.
The Court also stated that Genzyme could have filed a motion to exclude the references as evidence or asked the Board for leave to file a surreply. The Federal Circuit explained that “the introduction of new evidence in the course of the trial is to be expected” and confirmed 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.” Therefore, according to the Federal Circuit, the Board’s ruling complied with the requirements of the APA.
This decision clarifies that additional evidence may be introduced during the course of an IPR to support the instituted grounds, especially as a basis for defining the state of the art. As the decision shows, the Board may take an expansive view of the trial evidence and use it to support a final decision. Therefore, it is important for practitioners to consider all evidence of record when developing trial strategy.