The U.S. Court of Appeals for the Federal Circuit recently affirmed a decision by the USPTO Patent Trial and Appeal Board (PTAB) invalidating two patents after an inter partes review proceeding, even though the decision partially rested on references and evidence not disclosed in the challenger’s petition for review or the PTAB’s decision to institute. The appeals court ruled that the PTAB’s use of evidence developed during the IPR trial was not a violation of the Administrative Procedures Act and the patent owner had fair notice of the new evidence. Genzyme Therapeutic Products LP v. Biomarin Pharmaceutical Inc., No. 2015-1720 (Fed. Cir. June 14, 2016). The decision is significant because patent owners facing AIA post grant proceedings previously objected to the introduction of evidence outside the petition. The Genzyme decision casts doubt on the viability of that defense strategy.
The patent owner, Genzyme, owns two patents relating to the treatment of Pompe’s disease, a malady caused by the inability of a patient to metabolize glycogen, by administering a modified lysomal enzyme acid, α-glucosidase. Biomarin filed a petition for inter partes review under 35 U.S.C. § 311. Biomarin raised four grounds for unpatentability based on five references. The PTAB instituted review on two grounds, and declined to institute review on two grounds based on redundancy. During the trial, Genzyme argued that the claimed inventions were not obvious in light of the references, because all the references cited in the petition and decision to institute described in vitro experiments and a person skilled in the art would not have considered it likely that the results would be successful in live animals. In response, Biomarin cited two new references describing in vivo experiments to prove that the same results in live animals would be expected. The PTAB issued a final written decision ruling that the Genzyme patents were invalid as obvious, relying in part on the in vivo studies introduced by Biomarin.
Genzyme appealed the result to the Federal Circuit, including by arguing that the PTAB’s reliance on evidence not identified in the petition for review or decision to institute violated the procedural protections of the Administrative Procedures Act.
Federal Circuit Rules That Evidence in AIA Trials Not Limited to Petition
A three-judge panel of the Federal Circuit affirmed the PTAB’s ruling that the patents were unpatentable as obvious. The court noted that the APA places procedural limitations on AIA trials, including the right to notice and the opportunity to be heard. The PTAB’s final decision did not violate the Act, however, because the grounds and prior art relied upon for unpatentability were the same ones identified in the petition and the PTAB’s decision to institute.
The appeals court rejected Genzyme’s argument that the PTAB could not stray from the references identified in the petition and decision to institute, noting that the development of evidence already in the record or new evidence submitted after institution is to be expected during the course of an inter partes review trial proceeding:
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. Because the institution decision comes at the outset of the proceedings and the patentee is not obligated to respond before the Board makes its institution decision, it is hardly surprising that the Board cannot predict all the legal or factual questions that the parties may raise during the litigation. The development of evidence in the course of the trial is in keeping with the oppositional nature of an inter partes review proceeding. The 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.
Slip op. at 13-14 (citations and quotation omitted). The in vivo studies were applied as evidence that a person skilled in the art would have considered it likely that the techniques disclosed in the references cited in the petition and institution decision would be successful in animals. Ariosa Diagnostics v. Verinata Health, Inc., 805 F.3d 1359 (Fed. Cir. 2015) (PTAB may consider prior art reference to show state of art at time of invention even if reference not cited in institution decision).
The court also noted that Genzyme had actual notice of the in vivo studies, and had the opportunity to rebut the evidence. The court noted that Genzyme could have moved to exclude the evidence based on unfairness or sought an extension of time to prepare a response, but failed to do so.
The Genzyme decision appears to undercut a commonly used strategy where patent owners attempt to limit AIA challenges solely to the prior art references and essential facts identified in the petition. In contrast, Genzyme suggests that the factual record may be expanded during the AIA trial to support the grounds raised in the petition.
In practice, the very tight time restrictions in the AIA trial process, strict limits on the length of briefs, and the limited ability to conduct discovery may present difficulties for a patent owner to respond to any newly raised evidence or arguments. The Genzyme decision therefore underscores the importance of opposing a petition at the pre-institution stage, potentially stopping any trial. If a trial is instituted, patent owners should be aware that Genzyme supports the possibility of new arguments or evidence being introduced by a petitioner post-institution.