Trials@uspto.gov Paper No. 7
`571-272-7822 Entered: June 11, 2019
`
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`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`NALOX-1 PHARMACEUTICALS, LLC,
`Petitioner,
`
`v.
`
`OPIANT PHARMACEUTICALS, INC.,
`Patent Owner.
`____________
`
`Case Nos.
`IPR2019-00685, IPR2019-00686, and IPR2019-00687
`Patent No. 9,211,253 B2
`____________
`
`Before: ZHENYU YANG, JACQUELINE T. HARLOW, and
`MICHAEL A. VALEK, Administrative Patent Judges.
`
`VALEK, Administrative Patent Judge.
`
`Conduct of the Proceeding
`37 C.F.R. § 42.5
`
`
`
`
`
`
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`
`
`571-272-7822 Entered: June 11, 2019
`
`
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`NALOX-1 PHARMACEUTICALS, LLC,
`Petitioner,
`
`v.
`
`OPIANT PHARMACEUTICALS, INC.,
`Patent Owner.
`____________
`
`Case Nos.
`IPR2019-00685, IPR2019-00686, and IPR2019-00687
`Patent No. 9,211,253 B2
`____________
`
`Before: ZHENYU YANG, JACQUELINE T. HARLOW, and
`MICHAEL A. VALEK, Administrative Patent Judges.
`
`VALEK, Administrative Patent Judge.
`
`Conduct of the Proceeding
`37 C.F.R. § 42.5
`
`
`
`
`
`
`
`
`
`
`
`
`
`IPR2019-00685
`IPR2019-00686
`IPR2019-00687
`Patent No. 9,211,253 B2
`
`
`
`
`On February 18, 2019, Petitioner filed three Petitions, each requesting
`inter partes review of claims 1–29 of U.S. Patent No. 9,211,253 B2.1 In its
`Preliminary Responses, Patent Owner contends the Petitions in IPR2019-
`00686 and IPR2019-00687 are “secondary, redundant petitions” because
`they “merely add[] grounds that make the same arguments with more-
`complicated combinations of more references” than those set forth in
`IPR2019-00685. See, e.g., IPR2019-00687, Paper 6, 1–2. According to
`Patent Owner, “not only are large swaths of text word-for-word identical,”
`but each Petition “relies extensively on the Wyse reference that is the
`principal reference in Case IPR2019-00685.” Id. Patent Owner argues that
`we should exercise discretion to deny institution of IPR2019-00686 and
`IPR2019-00687 on this basis. Id.
`
`The Director has discretion to deny a petition under 35 U.S.C.
`§ 314(a). See Cuozzo Speed Techs., LLC v. Lee, 136 S. Ct. 2131, 2140
`(“[T]he agency’s decision to deny a petition is a matter committed to the
`Patent Office’s discretion.”). The Board takes into account various
`considerations when exercising discretion on behalf of the Director. See
`General Plastic Indus. Co. v. Canon Kabushiki Kaisha, Case IPR2016-
`01357 (PTAB Sept. 6, 2017) (Paper 19) (Section II.B.4.i. designated as
`precedential) (stating factors considered in Board’s exercise of discretion
`
`
`1 In all, Petitioner has challenged 5 patents with 15 separate petitions filed at
`or about the same time. According to Patent Owner, all of these patents
`relate to the same product, “NARCAN® Nasal Spray 4 mg.” IPR2019-
`00687, Paper 6, 1.
`
`2
`
`
`
`
`
`
`
`IPR2019-00685
`IPR2019-00686
`IPR2019-00687
`Patent No. 9,211,253 B2
`
`
`under 35 U.S.C. § 314(a)). Although the facts of General Plastic concern
`serial or “follow-on” petitions, the Office Trial Practice Guide Update notes
`[t]here may be other reasons besides the “follow-on” petition
`context where the “effect . . . on the economy, the integrity of the
`patent system, the efficient administration of the Office, and the
`ability of the Office to timely complete proceedings,” favors
`denying a petition even though some claims meet the threshold
`standards for institution.
`Office Trial Practice Guide Update2 referenced at 83 Fed. Reg. 39,989
`(“Trial Practice Guide Update”) (Aug. 13, 2018), at 10 (quoting 35 U.S.C.
`§ 316(b)).
`
`Maintaining multiple, concurrent proceedings per patent presents a
`significant burden for the Board, because, among other things, the Board
`endeavors to assign all such cases to the same panel. See SOP 1 (Rev. 15),
`III.G.3. Additionally, when there are other related patents also each
`challenged by multiple petitions at the same time, as is the case here, this
`can undermine the Office’s ability to complete proceedings in a timely
`manner and may place an unfair burden on Patent Owner. See Trial Practice
`Guide Update at 10; cf. General Plastic, slip op. at 16 (requiring the Board
`to consider ability to meet statutory deadlines as an institution factor); 37
`C.F.R. § 42.1(b) (“[The rules] shall be construed to secure the just, speedy,
`and inexpensive resolution of every proceeding.”).
`
`We agree with Patent Owner that the number of Petitions challenging
`the same patent here may place a substantial and unnecessary burden on the
`
`
`2 Available at https://go.usa.gov/xU7GP.
`3
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`IPR2019-00685
`IPR2019-00686
`IPR2019-00687
`Patent No. 9,211,253 B2
`
`
`Board and Patent Owner, particularly if we determine the Petitions rely on
`substantially overlapping grounds and theories. Accordingly, the panel
`issues this Order under 37 C.F.R. § 42.5 to give the parties an opportunity to
`focus the Board’s limited resources on genuine issues in dispute.
`Within 7 days of this Order, Petitioner shall provide a Notice not to
`exceed 3 pages identifying (1) a ranking of the three Petitions in the order in
`which it wishes the panel to consider the merits, if the Board uses its
`discretion to institute any of the Petitions, and (2) a succinct explanation of
`the differences between the Petitions, why the differences are material, and
`why the Board should exercise its discretion to consider the additional
`Petitions if it identifies a Petition that satisfies Petitioner’s burden under 35
`U.S.C. § 314(a). The Board encourages Petitioner to use a table to aid in
`identifying the similarities and differences between the Petitions.
`If it so chooses, Patent Owner may, within 7 days of the receipt of
`Petitioner’s Notice, provide a Response not to exceed 3 pages, stating its
`position with respect to any of the differences identified by Petitioner. In
`particular, Patent Owner should explain whether the differences identified
`by Petitioner are material and in dispute. If stating that reasons are not
`material or in dispute, Patent Owner should clearly proffer any necessary
`stipulations.3
`
`
`3 For example, Patent Owner may seek to avoid additional Petitions by
`proffering a stipulation that certain claim limitations or priority dates are not
`disputed.
`
`4
`
`
`
`
`
`IPR2019-00685
`IPR2019-00686
`IPR2019-00687
`Patent No. 9,211,253 B2
`
`
`
`
`Petitioner and Patent Owner are instructed to file the same paper in all
`proceedings and use this Order’s case caption format. The panel will
`consider the parties’ submissions in determining whether to exercise its
`discretion to institute inter partes review under 35 U.S.C. § 314(a).
`It is
`ORDERED that within 7 days of this Order, Petitioner shall file a
`
`Notice consistent with the foregoing instructions; and
`FURTHER ORDERED that, within 7 days of Petitioner’s Notice, if it
`chooses to, Patent Owner may file a Response consistent with the foregoing
`instructions.
`
`
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`
`
`5
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`
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`IPR2019-00685
`IPR2019-00686
`IPR2019-00687
`Patent No. 9,211,253 B2
`
`PETITIONER:
`
`Yelee Y. Kim
`Janine A. Carlan
`Richard Berman
`Bradford Frese
`Christopher Yaen
`ARENT FOX LLP
`Yelee.Kim@arentfox.com
`Janine.Carlan@arentfox.com
`Richard.Berman@arentfox.com
`Bradford.Frese@arentfox.com
`Christopher.Yaen@arentfox.com
`
`PATENT OWNER:
`
`Robert F. Green
`Jessica Tyrus Mackay
`GREEN, GRIFFITH & BORG-BREEN, LLP
`rgreen@greengriffith.com
`jmackay@greengriffith.com
`
`
`6
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`
`
`
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