Addressing issues related to introducing additional prior art references after institution of an inter partes review (IPR), the US Court of Appeals for the Federal Circuit affirmed a Patent Trial and Appeal Board (PTAB or Board) invalidity ruling, concluding that the opposing party was given proper notice of references not originally cited in the PTAB’s institution decisions. Genzyme Therapeutic Products Ltd. v. Biomarin Pharmaceutical Inc., Case Nos. 15-1720; -1721 (Fed. Cir., June 14, 2016) (Bryson, J).

Genzyme sued Biomarin alleging infringement of two patents directed to treating Pompe disease with injections of human acid α-glucosidase. Biomarin filed petitions requesting IPR of the two patents, and Genzyme filed responses to both IPRs. Biomarin filed a reply to the patent owner responses, citing two in vivo studies of enzyme replacement therapy for Pompe disease. The PTAB held the disputed claims of the two patents to be unpatentable as obvious. In its final written decisions, the PTAB referred to the state of the art in the two in vivo studies to conclude that “a person of ordinary skill in the art would have had a reasonable expectation of success” at the time of invention to achieve the results recited in the disputed claims. Genzyme appealed the invalidity rulings by the PTAB.

On appeal, Genzyme argued that the PTAB violated the notice requirements of the Administrative Procedure Act (APA). The Federal Circuit disagreed, noting that the provisions imposed by the APA have been interpreted to mean that an agency may not change theories in midstream without giving respondents reasonable notice of the change and the opportunity to present argument under the new theory. (See discussion of SAS v. ComplementSoft in this issue of IP Update). The Federal Circuit found no evidence that the PTAB changed theories midstream in this case, and explained that the grounds on which the PTAB invalidated the disputed claims in its final written decisions were the same as those in its institution decisions. 

The Federal Circuit explained 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.” Therefore the institution decision need not refer to every piece of evidence on which the PTAB relies in its final written decision. Here, Genzyme was denied neither notice nor an opportunity to respond to the in vivo studies. Indeed, Genzyme addressed the studies’ relevance in its responses to the petitions, and also failed to exercise its available procedural options to respond to Biomarin’s arguments or to try to exclude the studies. The Federal Circuit also agreed that the therapy strategy disclosed in the studies supported the PTAB’s conclusion that a person of ordinary skill would have had a reasonable expectation of success based on the grounds set forth in the institution decisions. The Federal Circuit therefore affirmed the PTAB’s final written decisions.

The Federal Circuit also noted that the introduction of new evidence after IPR institution is permissible as long as the opposing party has notice and an opportunity to respond to such new evidence irrespective of whether that evidence was cited in the PTAB’s institution decision.

Note: A prior art reference introduced into the proceedings after IPR institution can serve as notice to the opposing party of reliance on that prior art, and therefore, unless procedural options are exercised to limit the final written decision to references cited in the institution decision, the newly introduced prior art reference can become part of the grounds on which the PTAB can issue a final written decision.