BIODELIVERY SCIENCES INTL. v. AQUESTIVE THERAPEUTICS, INC.
Before Newman, Lourie, and Reyna. Appeal from the Patent Trial and Appeal Board (PTAB).
Summary: The PTAB has the discretion to not institute inter partes review even if there is a showing of reasonable likelihood of success with respect to at least one challenged claim. The PTAB’s institution decision is not appealable under 35 U.S.C. § 314(d).
BioDelivery filed three separate petitions for inter partes review (“IPR”) of a single patent owned by Aquestive containing a combined 17 grounds. The PTAB instituted review on a single ground in each of the three IPR petitions and found that BioDelivery failed to establish a reasonable likelihood of prevailing on the merits for the remaining grounds. The PTAB issued final written decisions sustaining patentability, and Biodelivery appealed. After oral arguments in the appeals, the Supreme Court issued its decision in SAS Institute, Inc. v Iancu, 138 S. Ct. 1348 (2018). BioDelivery moved to remand the proceedings in view of the decision in SAS. On remand, the PTAB modified the institution decisions. Instead of including all grounds in the IPR proceedings, the PTAB denied the three IPR petitions and terminated the proceedings. BioDelivery appealed, arguing that the PTAB could not reconsider its decision to institute on remand.
Aquestive moved to dismiss on the basis that review of the institution decision is barred under 35 U.S.C. § 314(d). The Federal Circuit granted the motion to dismiss, noting that the PTAB has the discretion to not institute review, even if there is a “reasonable likelihood of success with respect to at least 1 claimed challenged.” The Federal Circuit noted that the additional proceedings would have related to the 14 additional challenges that the PTAB did not believe met the threshold standard for institution and would have likely led to the same outcome. If the Federal Circuit required the PTAB to go through with these proceedings, it would contravene the Director’s statutory charge to consider the efficiency of the Patent Office.
Judge Newman dissented, stating that while the PTAB had discretion to decline institution of the IPR’s, the PTAB already instituted them and issued final written decisions. Accordingly, the PTAB failed to comply with the Federal Circuit’s remand order to merely implement the Supreme Court’s holding to provide a final written decision addressing all challenged claims.
Editor: Paul Stewart
