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Biodelivery Sciences International, Inc. v. Aquestive Therapeutics, Inc.

United States Court of Appeals, Federal Circuit

July 31, 2018

BIODELIVERY SCIENCES INTERNATIONAL, INC., Appellant
v.
AQUESTIVE THERAPEUTICS, INC., FKA MONOSOL RX, LLC, Appellee ANDREI IANCU, UNDER SECRETARY OF COMMERCE FOR INTELLECTUAL PROPERTY AND DIRECTOR OF THE UNITED STATES PATENT AND TRADEMARK OFFICE, Intervenor

          Appeals from the United States Patent and Trademark Office, Patent Trial and Appeal Board in Nos. IPR2015-00165, IPR2015-00168, IPR2015-00169.

          Lee Carl Bromberg, McCarter & English, LLP, Boston, MA, argued for appellant. Also represented by Erik Paul Belt, Kia Lynn Freeman, Wyley Sayre Proctor, Deborah M. Vernon; Danielle L. Herritt, Womble Bond Dickinson (US) LLP, Boston, MA; Cora Renae

          Holt, Howard Warren Levine, Thomas John Sullivan, Finnegan, Henderson, Farabow, Garrett & Dunner, LLP, Washington, DC; Charles E. Lipsey, Reston, VA; Jennifer Swan, Palo Alto, CA.

          John Lloyd Abramic, Steptoe & Johnson, LLP, Chicago, IL, argued for appellee. Also represented by Cassandra Adams, New York, NY; Harold Fox, James Francis Hibey, Gretchen P. Miller, Washington, DC; Jamie Lucia, San Francisco, CA.

          Molly R. Silfen, Office of the Solicitor, United States Patent and Trademark Office, Alexandria, VA, argued for intervenor. Also represented by Thomas W. Krause, Benjamin T. Hickman.

          Before Newman, Lourie, and Reyna, Circuit Judges.

         ON MOTION

          ORDER

          NEWMAN, CIRCUIT JUDGE.

         BioDelivery Sciences International, Inc. ("BioDelivery") moves to remand this case to the Patent Trial and Appeal Board to consider non-instituted claims and non-instituted grounds in accordance with the Supreme Court's recent decision in SAS Institute, Inc. v. Iancu, 138 S.Ct. 1348 (2018). Aquestive Therapeutics, Inc. ("Aquestive") and the PTO Director, who has intervened, oppose. Having considered the parties' arguments and our recent decisions interpreting SAS and requests based thereon, we remand.

         Discussion

         BioDelivery filed three petitions for inter partes review of U.S. Patent No. 8, 765, 167 ("the '167 Patent"). In IPR2015-00165, BioDelivery challenged a total of 22 claims (1, 4, 6-9, 11, 12, 26, 27, 32, 38, 44, 51, 58, 65, 72, 82, 109, and 125-127) based upon seven grounds of unpatentability. The PTAB instituted review of 15 claims (1, 4, 11, 12, 26, 27, 44, 51, 58, 65, 72, 82, and 125-127) based upon less than all asserted grounds. Similarly, in IPR2015-00168 and IPR2015-00169, the PTAB instituted on less than all asserted grounds of unpatentability but did institute on all challenged claims (16, 36, 42, 48, 55, 62, 69, 76, 86, 92, 122, and 123 for IPR2015-00168 and 17, 18, 30, 31, 37, 49, 56, 63, 70, 77, 80, 81, 87, 93, 110-116, and 124 for IPR2015-00169).

         The Patent Trial and Appeal Board ("PTAB") decided each petition separately, and issued separate final written decisions that sustained the patentability of all instituted claims of the '167 Patent on all instituted grounds, and included discussion concerning the application of collateral estoppel between inter partes reexamination and inter partes review. BioDelivery appealed the PTAB's three decisions to this court. Aquestive responded, and the Director intervened to confess error as to the PTAB's assumption that inter partes reexamination could give rise to collateral estoppel in inter partes review.

         This court received oral argument in the three appeals on February 9, 2018. On April 24, 2018, the Supreme Court issued its decision in SAS Institute, Inc. v. Iancu, 138 S.Ct. 1348 (2018), explaining that in establishing inter partes review, Congress set forth "a process in which it's the petitioner, not the Director, who gets to define the contours of the proceeding." 138 S.Ct. at 1355. The Court held that if the Director institutes review proceedings, the PTAB review must proceed "in accordance with or in conformance to the petition," id. at 1356 (internal quotations omitted), including "'each claim challenged' and 'the grounds on which the challenge to each claim is based, '" id. at 1355 (quoting 35 U.S.C. § 312(a)(3)). The Court stated: "Nothing suggests the Director enjoys a license to depart from the petition and institute a different inter partes review of his own design." Id. at 1356 (emphasis in original). Thus the Court emphasized that "the petitioner's petition, not the Director's discretion, is supposed to guide the life of the litigation," id., and that "the petitioner's contentions, not the Director's discretion, define the scope of the litigation all the way from institution through to conclusion," id. at 1357.

         Nine days after the Court's SAS decision issued, BioDelivery requested that this court remand the final decision in IPR2015-00165 to consider the patentability of the non-instituted claims. See ECF No. 88. In response, Aquestive argued that BioDelivery had waived any SAS-based relief for failing to raise any issue of non-instituted claims during this appeal. Se ...


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