Submission of New Evidence After Institution of an IPR is “Perfectly Permissible”

Last week, in Genzyme v. Biomarin, the Court of Appeals for the Federal Circuit held petitioners may introduce new evidence after an institution decision in IPR proceedings as long as the opposing party received notice of the new evidence and an opportunity to respond.

In its final written decision, the PTAB relied on references beyond those cited in its institution decision to demonstrate the state of the art at the time of the invention. On appeal, Genzyme argued that by citing references not set forth in the institution decision, the PTAB’s final written decision violated the Administrative Procedure Act’s (APA) requirement of notice and an opportunity to be heard.

The court rejected Genzyme’s argument and held that “[t]here 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 court continued to hold that “[t]he  purpose of the trial in an inter partes review proceeding is to give the parties an opportunity to build a record by introducing evidence—not simply to weigh evidence of which the Board is already aware.”  Consequently, “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.” Notably, the grounds relied upon by the PTAB in the final written decision were the same as those identified in the institution decision.

The APA requires that the PTAB provide the patent holder timely notice of the matters of fact and law asserted and an opportunity to respond with facts and arguments. This requirement serves to prevent the PTAB from changing theories midstream without giving the patent holder reasonable notice of the change and an opportunity to submit arguments under the new theory. Genzyme argued that the additional publications should not be relied on because they were not cited in the institution decision. The court held that the record established that Genzyme received both sufficient notice of the new evidence and an opportunity to submit responsive argument.

Takeaway: It remains best practice for ANDA-filers to present all of their evidence prior to institution.  If additional evidence comes to light after the PTAB institutes the petition, however, the PTAB should be willing to consider that new evidence as long as the opposing party was given fair notice and a meaningful opportunity to respond.