BioDelivery Sciences Int., Inc. v. Aquestive Therapeutics, Inc. et al. (USPTO as Intervenor)

Docket No. 2017-1265-68 (IPR2015-00165, -00168, -00169)

July 31, 2018

Brief summary: BioDelivery’s requests for remand under SAS because the PTAB instituted IPRs on less than all asserted grounds granted and the PTAB’s FWDs were vacated.

Summary: BioDelivery moved to remand the case to the PTAB “to consider non-instituted claims and non-instituted grounds” in view of SCOTUS’s SAS decision (US 2018). The FC panel explains that that the IPRs against US 8,765,167 were instituted IPR on 15 of 22 claims challenged in the ‘165 IPR, and “on less than all asserted grounds of unpatentability but…on all challenged claims” in the ‘168 and ‘169 IPRs. The PTAB “decided each petition separately, and issued separate final written decisions” (FWDs) sustaining “the patentability of all instituted claims of the ‘167 patent on all instituted grounds”. Included in the FWDs was a discussion by the PTAB “concerning the application of collateral estoppel between inter partes reexamination and inter partes review” that the PTAB subsequently “confess[ed]” was erroneous. Oral arguments too place on Feb. 9, 2018, before SCOTUS’s April 24, 2018 SAS decision which explains “that in establishing [IPR], Congress set forth ‘a process in which it’s the petitioner, not the Director, who gets to define the contours of the proceeding” and that “the PTAB review must proceed ‘in accordance with or in conformance with the petition’…including ‘each claim challenged; and ‘the grounds on which the challenge to each claim is based’” (“Nothing suggests the Director enjoys a license to depart from the petition and institute a different inter partes review of his own design.”) The FC Order explained that about when BioDelivery files its requests, “[o]rders in other cases began to issue from this court, applying the Court’s decision in SAS and outlining the contours of SAS-based requests for relief” (Ulthera, FC, May 25, 2018; Polaris, FC 2018 (declining “to find a party waived its right to seek SAS-based relief due to failure to argue against partial institution before the PTAB”); PGS Geophysical, FC 2018; Medtronic, FC 2018; Adidas AG, FC July 2, 2018; Broad Ocean, FC June 14, 2018; Nestle Purina, FC June 11, 2018; Baker Hughes, FC May 30, 2018). The FC panel explained that, as in the FC’s Polaris decision, “SAS represented a significant change in law that occurred during the pendency of BioDelivery’s appeals” and “that waiver does not apply”. The FC Order also explained that BioDelivery’s first request for “SAS-based relief” nine days after the SAS decision, and its subsequent requests “soon after this court began ordering remands”, were not untimely (“not untimely simply because BioDelivery did not predict that this court would authorize requests for remand when the PTAB instituted on less than all grounds as well as on all claims”). Also, the FC panel found that it did not need to “first decide the presently appealed issues” before deciding on the SAS-based remand issue as “precisely the type of piecemeal litigation that is historically disfavored” (W.L. Gore, FC 1992) and that Aquestive would not be prejudiced by remand. Thus, BioDelivery’s requests for remand were granted and the PTAB’s FWDs vacated.

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

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