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935 F.3d 1362
Fed. Cir.
2019
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Background

  • BioDelivery filed three IPR petitions challenging U.S. Patent No. 8,765,167 with a total of 17 grounds; the PTAB initially instituted each petition on only one ground and declined the other 14.
  • The PTAB conducted trials and issued final written decisions sustaining the patentability of the instituted claims; BioDelivery appealed.
  • After argument, the Supreme Court decided SAS Institute v. Iancu, holding the PTAB cannot partially institute — if it institutes, it must address all claims and grounds in the petition; the Federal Circuit remanded for the PTAB to "implement SAS."
  • On remand the PTAB reconsidered institution, evaluated the previously non-instituted grounds, and reversed its prior partial institutions by denying institution in each proceeding and terminating the IPRs as an exercise of discretion and efficiency.
  • BioDelivery appealed the PTAB’s remand decisions; the Federal Circuit dismissed the appeals, holding § 314(d) bars judicial review of the PTAB’s decisions whether to institute (including reconsiderations that terminate proceedings).

Issues

Issue Plaintiff's Argument Defendant's Argument Held
Whether the PTAB’s decision on remand to vacate prior partial institutions and deny institution is reviewable BioDelivery: PTAB must comply with the Federal Circuit’s remand to "implement SAS" and produce final written decisions covering all petitioned grounds; the remand mandate controls and is reviewable PTAB/Director: The decision not to institute (including on reconsideration) is discretionary under §314(a) and unreviewable under §314(d); vacatur/termination is a final nonappealable institution decision Held: Appeals dismissed — §314(d) bars review of the PTAB’s determinations whether to institute, including its remand decisions to deny institution and terminate proceedings
Whether once instituted an IPR must proceed to a final written decision addressing all petitioned grounds BioDelivery: Having conducted trials and issued final decisions on instituted portions, the PTAB must now address all petitioned grounds as required by SAS and the remand PTAB: SAS can be implemented by either instituting on all grounds or declining institution; administrative efficiency and discretion permit vacating prior institution and terminating Held: PTAB may exercise discretion to deny institution on remand; there is no requirement that an instituted IPR must continue to final written decision on all grounds if the PTAB properly reexamines and declines to institute
Scope of §314(d) (finality/nonappealability) when PTAB reconsiders institution after initial institution BioDelivery: Reconsideration that nullifies completed proceedings conflicts with appellate mandate and is subject to judicial oversight PTAB/majority: §314(d) bars review of institution decisions, and this includes decisions on reconsideration that determine whether to institute Held: §314(d) precludes review of the PTAB’s remand decisions modifying prior institutions; such decisions are treated as final and nonappealable institution determinations
Proper remedy to implement SAS after partial institution BioDelivery: Mandate required the PTAB to issue full final written decisions covering all grounds raised in petitions PTAB/majority: Two lawful methods to implement SAS — (1) institute on all grounds (leading to full trials) or (2) re-evaluate and decline to institute on any grounds; the latter better serves efficiency when other grounds lack threshold merit Held: PTAB permissibly chose to deny institution on remand as an appropriate method to implement SAS, and that choice is not reviewable under §314(d)

Key Cases Cited

  • Cuozzo Speed Technologies, LLC v. Lee, 136 S. Ct. 2131 (administrative decision to institute IPR is generally nonappealable under §314(d))
  • SAS Institute Inc. v. Iancu, 138 S. Ct. 1348 (PTAB may not partially institute; if it institutes it must address all claims and grounds in the petition)
  • Medtronic, Inc. v. Robert Bosch Healthcare Sys., Inc., 839 F.3d 1382 (PTAB vacatur of institution and termination of IPR constitute nonappealable institution decisions)
  • PGS Geophysical AS v. Iancu, 891 F.3d 1354 (SAS requires a yes-or-no institution choice embracing all challenges in a petition)
  • GTNX, Inc. v. INTTRA, Inc., 789 F.3d 1309 (agency reconsideration and termination can constitute nonappealable institution decisions)
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Case Details

Case Name: Biodelivery Scis. Int'l, Inc. v. Aquestive Therapeutics, Inc.
Court Name: Court of Appeals for the Federal Circuit
Date Published: Aug 29, 2019
Citations: 935 F.3d 1362; 2019-1643; 2019-1644; 2019-1645
Docket Number: 2019-1643; 2019-1644; 2019-1645
Court Abbreviation: Fed. Cir.
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    Biodelivery Scis. Int'l, Inc. v. Aquestive Therapeutics, Inc., 935 F.3d 1362