BioDelivery Sciences International, Inc.. v. Aquestive Therapeutics, Inc., No. 17-1265 (Fed. Cir. 2018)Annotate this Case
BioDelivery filed petitions for inter partes review (IPR) of Aquestive's Patent. The Patent Trial and Appeal Board (PTAB) instituted review of fewer than all of the asserted claims based upon fewer than all asserted grounds and issued final written decisions that sustained the patentability of all instituted claims on all instituted grounds and included a discussion of collateral estoppel between inter partes reexamination and IPR. On appeal, PTAB acknowledged error in its assumption that inter partes reexamination could give rise to collateral estoppel in IPR. After oral argument in the Federal Circuit, the Supreme Court issued its 2018 “SAS” decision, explaining that the petitioner, not the Director defines the contours of the IPR; if the Director institutes review, PTAB review must proceed “in accordance with or in conformance to the petition,” including “‘each claim challenged’ and ‘the grounds on which the challenge to each claim is based,’” BioDelivery requested remand to consider the patentability of the non-instituted claims. Aquestive and the Patent Office argued that BioDelivery had waived SAS-based relief by failing to raise any issue of non-instituted claims on appeal. The Federal Circuit granted a remand; waiver does not apply and the motion is not untimely. The PTO’s salutary decision concerning future action does not insulate earlier PTAB actions from remedy.