Board properly decided to deny institution and dismiss IPRs on SAS remand instead of instituting on all grounds


BioDelivery Sciences Int., Inc. v. Aquesitive Therapeutics, Inc., FKA Monsol Rx, LLC

Docket No. 2019-1643-45 (IPR2015-00165, -00168, -00169)
NEWMAN (D), LOURIE, REYNA (Order)
August 26, 2019

Brief Summary: On remand under SAS after instituting IPRs on less than all the alleged grounds, the FC panel approved the Board’s decision to deny IPR on all grounds instead of proceeding all the grounds.

Summary: BioDelivery’s previous appeal of the Board’s IPR final written decisions (FWDs) based on institution of review of the claims of US 8,765,167 on less than all of the grounds (three of 14) alleged in BioDelivery’s three petitions, was granted based on SCOTUS’s 2018 SAS decision “that IPR proceedings 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’” (section 312(a)(3); BioDelivery, FC 2018). On remand, after considering whether it could deny institution and whether BioDelivery had shown a reasonable likelihood of succeeding, “the Board modified the institution decisions, denied the petitions, and terminated the proceedings”, emphasizing its “discretion to institute IPR under 35 U.S.C. section 314(a) even upon a showing of a reasonable likelihood of prevailing on at least one challenged claim” (citing SAS and section 316(b) (“efficient administration of the Office”); Medtronic, FC 2016; GNTX, FC 2015). BioDelivery argued this was improper. The FC panel first explained that “[s]ection 314(d) plainly states that the Patent Office’s decision whether to institute IPR is not appealable” and “there is no requirement that once instituted, IPRs must proceed through final written decisions” since, e.g., “administrative agencies possess inherent authority to reconsider their decisions” (Medtronic; Tokyo Kikai, FC 2008). Here, the FC panel explained, “the Board initially erred under SAS by instituting partial review instead of making yes-or-no institution decisions” and then “properly exercise[ed] its discretion not to instituted review at all” (noting the Board could have instituted review on all challenges). Thus, the FC panel dismissed BioDelivery’s appeals. Judge Newman’s dissent argued that on remand, the Board was instructed to “implement the Court’s decision [in] SAS” but instead “declined to execute our Remand Order” and improperly “discarded these three completed IPR cases as if they had never occurred.”

This entry was posted in Appeal, Inter Parties Review (IPR), IPR, Uncategorized. Bookmark the permalink.

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