Trials@uspto.gov Paper No. 7
`Tel: 571-272-7822
`Entered: December 7, 2018
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_______________
`
`AQUESTIVE THERAPEUTICS, INC.,
`Petitioner,
`
`v.
`
`ICOS CORPORATION,
`Patent Owner.
`____________
`
`Case IPR2018-01183
`Patent 6,943,166 B1
`_______________
`
`
`Before SUSAN L. C. MITCHELL, ZHENYU YANG, and
`KRISTI L. R. SAWERT, Administrative Patent Judges.
`
`
`YANG, Administrative Patent Judge.
`
`
`
`
`
`
`
`DECISION
`Denying Institution of Inter Partes Review
`35 U.S.C. § 314
`
`
`
`
`
`
`Tel: 571-272-7822
`Entered: December 7, 2018
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_______________
`
`AQUESTIVE THERAPEUTICS, INC.,
`Petitioner,
`
`v.
`
`ICOS CORPORATION,
`Patent Owner.
`____________
`
`Case IPR2018-01183
`Patent 6,943,166 B1
`_______________
`
`
`Before SUSAN L. C. MITCHELL, ZHENYU YANG, and
`KRISTI L. R. SAWERT, Administrative Patent Judges.
`
`
`YANG, Administrative Patent Judge.
`
`
`
`
`
`
`
`DECISION
`Denying Institution of Inter Partes Review
`35 U.S.C. § 314
`
`
`
`
`
`
`
`IPR2018-01183
`Patent 6,943,166 B1
`
`
`INTRODUCTION
`
`Aquestive Therapeutics, Inc., formerly MonoSol Rx, LLC
`
`(“Petitioner”), filed a Petition (Paper 1, “Pet.”) to institute an inter partes
`
`review of claims 112 of U.S. Patent No. 6,943,166 B1 (Ex. 1001, “the ’166
`
`patent”). ICOS Corporation (“Patent Owner”) filed a Preliminary Response.
`
`Paper 6 (“Prelim. Resp.”).
`
`For the reasons provided below, we deny institution of an inter partes
`
`review. See 35 U.S.C. § 314(a).
`
`Related Proceedings
`
`According to the parties, Patent Owner asserted the ’166 patent
`
`against numerous entities, but not Petitioner, in the district courts. Pet. 59;
`
`Paper 5, 1–2.
`
`We previously denied a petition for inter partes review of the same
`
`challenged claims filed by IntelGenX Corporation. IPR2016-00678,
`
`Paper 13. Thereafter, IntelGenX filed a request for rehearing, and we
`
`authorized Patent Owner to file a responsive brief. IPR2016-00678, Papers
`
`14, 15. Before Patent Owner filed any responsive briefing, Petitioner
`
`withdrew its request, and we terminated that proceeding. IPR2016-00678,
`
`Papers 16, 17.
`
`The ’166 patent is the subject of IPR2017-00323, filed by Mylan
`
`Pharmaceuticals Inc. We instituted an inter partes review in that case.
`
`IPR2017-00323, Paper 12. Because the parties later settled, we terminated
`
`that proceeding as well. IPR2017-00323, Paper 19.
`
`The ’166 patent is also the subject of IPR2017-01757 and
`
`IPR2017-01762, filed by Dr. Reddy’s Laboratories, Inc. and Argentum
`
`Pharmaceuticals LLC, respectively. Each of those petitioners also sought to
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`IPR2018-01183
`Patent 6,943,166 B1
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`join the Mylan case. Before we decided on either petition, however, the
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`parties settled. We, thus, terminated those proceedings. IPR2017-01757,
`
`Paper 12; IPR2017-01762, Paper 11.
`
`Petitioner here, under its former name MonoSol, filed
`
`IPR2017-00412, challenging claims 1–12 of the ’166 patent. After
`
`substantive analysis, we denied that petition. IPR2017-00412, Paper 18.
`
`Asserted Grounds of Unpatentability
`
`Petitioner asserts the following grounds, each of which challenges the
`
`patentability of claims 1–12:
`
`Reference(s)
`Basis
`§ 103 Daugan,1 SNDA,2 and the FDA Guideline3
`§ 103 Daugan, SNDA, the FDA Guideline, and Cutler4
`§ 103 Daugan, SNDA, the FDA Guideline, and Ruberg5
`
`DISCUSSION
`
`Institution of inter partes review is discretionary. See 35 U.S.C.
`
`§ 314(a); Harmonic Inc. v. Avid Tech, Inc., 815 F.3d 1356, 1367 (Fed. Cir.
`
`2016) (explaining that under § 314(a), “the PTO is permitted, but never
`
`compelled, to institute an IPR proceeding”). When determining whether to
`
`
`1 Daugan, WO 97/03675, published Feb. 6, 1997 (Ex. 1005).
`2 Center for Drug Evaluation and Research, Approval Package for
`VIAGRA®, Approval Date March 27, 1998 (Ex. 1011, “SNDA”).
`3 Dose-Response Information to Support Drug Registration, 59 Fed. Reg.
`55972 (Nov. 9, 1994) (Ex. 1014, “the FDA Guideline”).
`4 Cutler, et al., Defining the Maximum Tolerated Dose: Investigator,
`Academic, Industry and Regulatory Perspectives, 37 J. CLIN. PHARMACOL.
`767–83 (1997) (Ex. 1016).
`5 Ruberg, Dose Response Studies I. Some Design Considerations, 5 J.
`BIOPHARM. STAT. 1–14 (1995) (Ex. 1018).
`
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`IPR2018-01183
`Patent 6,943,166 B1
`
`exercise our discretion under § 314(a), we consider the following
`
`non-exhaustive factors:
`
`1. whether the same petitioner previously filed a petition directed
`to the same claims of the same patent;
`
`2. whether at the time of filing of the first petition the petitioner
`knew of the prior art asserted in the second petition or should
`have known of it;
`
`3. whether at the time of filing of the second petition the
`petitioner already received the patent owner’s preliminary
`response to the first petition or received the Board’s decision
`on whether to institute review in the first petition;
`
`4. the length of time that elapsed between the time the petitioner
`learned of the prior art asserted in the second petition and the
`filing of the second petition;
`
`5. whether the petitioner provides adequate explanation for the
`time elapsed between the filings of multiple petitions directed
`to the same claims of the same patent;
`
`6. the finite resources of the Board; and
`
`7. the requirement under 35 U.S.C. § 316(a)(11) to issue a final
`determination not later than 1 year after the date on which the
`Director notices institution of review.
`
`Gen. Plastic Indus. Co. v. Canon Kabushiki Kaisha, IPR2016-01357, Paper
`
`19, 15–16 (PTAB Sept. 6, 2017) (precedential).
`
`After weighing these factors, we agree with Patent Owner that it is
`
`appropriate to deny institution of this second petition by Petitioner
`
`challenging the same claims of the ’166 patent. See Prelim. Resp. 5–21.
`
`The first two factors, for example, weigh heavily in favor of denying
`
`institution. Petitioner, under its former name MonoSol, previously
`
`unsuccessfully challenged the same claims of the ’166 patent in
`
`IPR2017-00412. And at the time of filing IPR2017-00412, Petitioner knew
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` 4
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`IPR2018-01183
`Patent 6,943,166 B1
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`of at least four of the five references asserted here (Daugan, SNDA, the FDA
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`Guideline, and Cutler). Regarding Ruberg, the only newly asserted prior art
`
`in this case, Petitioner states that it “was not previously known to Aquestive
`
`(or MonoSol) until a few weeks” before it filed this Petition. Pet. 5. But
`
`Ruberg was originally published in the Journal of Biopharmaceutical
`
`Statistics in 1995, and was published online in 2007. Petitioner should have
`
`known of Ruberg, and provides no explanation of why it was unaware of it.
`
`Other factors also weigh in favor of denying institution. At the time
`
`of filing this Petition, Petitioner not only received Patent Owner’s
`
`preliminary response but also our initial decision denying IPR2017-00412
`
`and the decision denying its rehearing request. Patent Owner provides
`
`detailed accounts of how Petitioner used those decisions as a roadmap to
`
`reformulate its argument. Prelim. Resp. 9–13. We agree with Patent
`
`Owner’s analysis.
`
`In addition, Petitioner filed this Petition 18 months after filing
`
`IPR2017-00412 without reasonable justification. Petitioner argues that it
`
`“had considered a joinder with Mylan’s granted Petition [i.e., IPR2017-
`
`00323], however, Mylan settled out of proceedings on July 7, 2017, making
`
`joinder legally impossible.” Pet. 3. But in IPR2017-00323, we granted that
`
`petition on June 12, 2017, nearly a month before the parties filed their joint
`
`motion to terminate the proceeding. Petitioner had at least four weeks to
`
`join IPR2017-00323 after institution, but did not do so. See 37 C.F.R.
`
`§ 122(b) (stating a party has up to one month after the institution date of the
`
`case it seeks to join to file a joinder motion).
`
`Petitioner also analogizes this case with Panduit Corp. v. CCS
`
`Technology Inc., IPR2017-01375, where a Board panel instituted review
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`IPR2018-01183
`Patent 6,943,166 B1
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`based on a follow-on petition. Pet. 4. We are not persuaded by this
`
`argument that we should address the merits of this Petition. Putting aside
`
`other factual differences between the two cases, we reject Petitioner’s
`
`argument that “Petitioner had relied on a proffered declaration supporting
`
`public accessibility [of two references asserted in its earlier Petition in
`
`IPR2017-00412], which is not unreasonable.” Id. In Petitioner’s previous
`
`case, we explained that those two references discussed events with dates
`
`after the priority date of the ’166 patent. IPR2017-00412, Paper 11, 10–11.
`
`Petitioner’s reliance on a declaration that was not supported by the
`
`references themselves, thus, was unreasonable. It certainly does not provide
`
`Petitioner with another opportunity to, using our previous decisions as a
`
`roadmap, challenge the same claims anew.
`
`Under the totality of the circumstances in this case, we exercise our
`
`discretion under 35 U.S.C. § 314(a) to deny the Petition.
`
`
`
`Accordingly, it is
`
`ORDER
`
`ORDERED that Petitioner’s request for an inter partes review of
`
`claims 1–12 of the ’166 patent is denied and no inter partes review is
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`instituted.
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`IPR2018-01183
`Patent 6,943,166 B1
`
`PETITIONER:
`
`Harold Fox
`hfox@steptoe.com
`
`Gretchen Miller
`gmiller@steptoe.com
`
`
`PATENT OWNER:
`
`Mark Feldstein
`Mark.feldstein@finnegan.com
`
`Joshua Goldberg
`Joshua.goldberg@finnegan.com
`
`Yieyie Yang
`Yieyie.yang@finnegan.com
`
`Charles Mitchell
`Charles.mitchell@finnegan.com
`
`Mark Stewart
`Stewart_mark@lilly.com
`
`Dan Wood
`Wood_dan_l@lilly.com
`
`Gerlad Keleher
`Gpk1@lilly.com
`
`
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