BioDelivery Sciences International, Inc. v. Aquestive Therapeutics, Inc., No. 19-1643 (Fed. Cir. 2019)Annotate this Case
In 2014, BioDelivery filed three petitions for inter partes review (IPR) of Aquestive’s 167 patent. The Patent Trial and Appeal Board instituted review on a single ground in each petition. For the 14 non-instituted grounds, the Board found that BioDelivery failed to establish a reasonable likelihood of prevailing on the merits. The Board sustained the patentability of the three claims. The Supreme Court then issued its SAS Institute (2018) holdings that IPR proceedings must proceed in accordance with the petition including the grounds on which the challenge to each claim is based. On remand, the Board modified the institution decisions, denied the petitions, and terminated the proceedings, emphasizing its discretion to institute IPR under 35 U.S.C. 314(a) even upon a showing of a reasonable likelihood of prevailing on at least one challenged claim. The Board considered the merits of the previously noninstituted grounds, finding that BioDelivery had not “establish[ed] a reasonable likelihood of success in relation to those claims and grounds.” The Federal Circuit dismissed BioDelivery’s appeals as barred by 35 U.S.C. 314(d). In following the remand order to “implement SAS,” the Board corrected its partial institution errors by revisiting its institution decisions and properly exercising its discretion not to institute review at all. Nothing in the order divested the Board of that discretion.