`
`571-272-7822
` Entered: August 27, 2018
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`
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`BIODELIVERY SCIENCES INTERNATIONAL, INC.,
`Petitioner,
`
`v.
`
`MONOSOL RX, LLC,1
`Patent Owner.
`____________
`
`Cases IPR2015-00165,
`IPR2015-00168, and IPR2015-00169
`Patent 8,765,167 B22
`____________
`
`Before JACQUELINE WRIGHT BONILLA, Vice Chief Administrative
`Patent Judge, FRANCISCO C. PRATS and ZHENYU YANG,
`Administrative Patent Judges.
`
`Per Curiam.
`
`
`ORDER
`Conduct of the Proceeding
`37 C.F.R. § 42.5
`
`
`1 The caption of the Order remanding these proceedings to the Board
`identifies “AQUESTIVE THERAPEUTICS, INC., fka MonoSol Rx, LLC”
`as the Patent Owner. BioDelivery Scis. Int’l. v. Aquestive Therapeutics, Inc.,
`2018 WL 3625151 (Fed. Cir. 2018). The parties are reminded of their
`obligation to maintain up-to-date Mandatory Notices. See 37 C.F.R. § 42.8.
`
`2 This order addresses issues involving all of the identified cases. We
`exercise our discretion to issue one order to be filed in each case. The
`parties are authorized to use this style heading when filing a single paper in
`all three proceedings, provided that such heading includes a footnote
`attesting that “the word-for-word identical paper is filed in each proceeding
`identified in the heading.”
`
`
`
`IPR2015-00165, IPR2015-00168, and IPR2015-00169
`Patent 8,765,167 B2
`
`
`In response to requests by BioDelivery Sciences International, Inc.
`
`(“Petitioner”), the United States Court of Appeals for the Federal Circuit
`
`(“Federal Circuit”) has remanded Petitioner’s appeals of this Board’s final
`
`decisions in each of IPR2015-00165, IPR2015-00168, and IPR2015-00169
`
`to “implement the [Supreme] Court’s decision in SAS [Institute Inc. v. Iancu,
`
`138 S. Ct. 1348 (2018)].” BioDelivery Scis. Int’l. v. Aquestive Therapeutics,
`
`Inc., 2018 WL 3625151 at *4 (Fed. Cir. 2018).
`
`In its Order, the Federal Circuit stated that the Board’s “decisions in
`
`PTAB Nos. IPR2015-00165, IPR2015-00168, and IPR2015-00169, are
`
`vacated.” Id.
`
`In SAS, the Supreme Court held that a decision to institute under 35
`
`U.S.C. § 314 may not institute a review proceeding on fewer than all claims
`
`challenged. SAS, 138 S. Ct. at 1354. The Federal Circuit directs that, if the
`
`Director institutes a proceeding, “SAS requires institution on all challenged
`
`claims and all challenged grounds.” BioDelivery v. Aquestive, 2018 WL
`
`3625151 at *3 (citing PGS Geophysical AS v. Iancu, 891 F.3d 1354, 1360
`
`(Fed. Cir. 2018) (“Equal treatment of claims and grounds for institution
`
`purposes has pervasive support in SAS.”)).
`
`Pursuant to the Federal Circuit’s Order to implement the Supreme
`
`Court’s decision in SAS, we direct the parties to submit briefing addressing
`
`specifically whether an appropriate course of action going forward would be
`
`to vacate our prior institution decisions in these proceedings and deny the
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`petitions in their entireties at this time.
`
`The parties are reminded that, at the original institution stage of these
`
`proceedings, a significant majority of the grounds presented by Petitioner
`
`
`
`2
`
`
`
`IPR2015-00165, IPR2015-00168, and IPR2015-00169
`Patent 8,765,167 B2
`
`were determined on the merits not to meet the standard for institution of
`
`trial. See IPR2015-00165, Paper 6, 10–31 (instituting as to one of seven
`
`grounds of unpatentability; four of seven grounds determined not to meet
`
`institution standard on the merits; two other grounds denied because
`
`presented on contingent basis); IPR2015-00168, Paper 6, 9–18 (instituting as
`
`to one of five grounds; four of five grounds determined not to meet
`
`institution standard on the merits); IPR2015-00169, Paper 6, 10–23
`
`(instituting as to one of five grounds; four of five grounds determined not to
`
`meet institution standard on the merits). In addition, in relation to each
`
`instituted ground in each case, as addressed in our final written decisions in
`
`the three IPRs at issue, we determined that Petitioner had not shown by a
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`preponderance of the evidence that any challenged claim of the ’167 patent
`
`was unpatentable.
`
`Because we previously denied institution as to a significant majority
`
`of grounds presented by Petitioner, and because we “sustained the
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`patentability of all instituted claims of the ’167 Patent on all instituted
`
`grounds” in our final written decisions, we direct the parties to submit
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`briefing addressing specifically whether an appropriate course of action
`
`would be to vacate our prior institution decisions and deny the petitions now,
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`in view of the Federal Circuit’s recent decision to vacate and remand our
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`final written decisions “to implement the Court’s decision in SAS.”
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`BioDelivery Scis., 2018 WL 3625151 at *1, *4.
`
`The parties’ briefing regarding the propriety of denying institution
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`shall be no more than ten (10) pages long, and shall be submitted no later
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`than September 10, 2018.
`
`
`
`3
`
`
`
`IPR2015-00165, IPR2015-00168, and IPR2015-00169
`Patent 8,765,167 B2
`
`
`In consideration of the foregoing, it is hereby:
`
`ORDERED that by September 10, 2018, the parties shall, either
`
`jointly or separately, in accordance with the directions above, submit
`
`briefing that addresses specifically whether denying institution is the
`
`appropriate course of action at this stage in all three proceedings, in view of
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`the Federal Circuit’s decision to vacate and remand our final written
`
`decisions in view of SAS.
`
`
`
`4
`
`
`
`IPR2015-00165, IPR2015-00168, and IPR2015-00169
`Patent 8,765,167 B2
`
`PETITIONER:
`
`Dannielle L. Herritt
`Deborah M. Vernon
`Kia L. Freeman
`MCCARTER & ENGLISH, LLP
`djerrott@mccarter.com
`devernon@mccarter.com
`kfreeman@mccarter.com
`
`
`
`PATENT OWNER:
`
`Daniel A. Scola Jr.
`Michael I. Chakansky
`HOFFMANN & BARON, LLP
`dscola@hbiplaw.com
`mchakansky@hbiplaw.com
`165ipr@hbiplaw.com
`
`
`
`
`
`
`
`
`
`5
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`