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`UNITED STATES PATENT AND TRADEMARK OFFICE
`__________________
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`__________________
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`NALOX-1 PHARMACEUTICALS, LLC,
`Petitioner,
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`v.
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`ADAPT PHARMA LIMITED, and
`OPIANT PHARMACEUTICALS, INC.,
`Patent Owners.
`__________________
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`Cases IPR2019-00691, IPR 2019-00692, and IPR 2019-00693
`Patent 9,561,177
`__________________
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`PATENT OWNERS’ RESPONSE TO PETITIONER’S NOTICE
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`Cases IPR2019-00691, -00692, and -00693
`Patent 9,561,177
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`Petitioner’s Notice confirms that the Wang and Davies Petitions are redundant
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`of the Wyse Petition. Like Patent Owners, Petitioner ranks the Wyse Petition
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`(IPR2019-00691) first, ahead of the Wang and Davies Petitions (-00692 and -00693).
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`Petitioner largely dodges the Board’s request for an explanation of the
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`differences among the Petitions. Petitioner’s handful of examples of alleged
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`differences largely boil down to reasons why Wang and Davies teach fewer claim
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`limitations and are even weaker references than Wyse. As Patent Owners explained
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`in their Preliminary Responses, all three Petitions have fatal deficiencies. In addition,
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`the district court trial related to these Petitions is scheduled to start in two weeks. The
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`Board should thus decline to institute any of the IPR proceedings. But if the Board
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`institutes anything, it should institute only the Wyse Petition.
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`First, Petitioner asserts that the Wyse Petition presents different issues because
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`Wyse may not be prior art if the claims that were ultimately granted in the ’177 patent
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`are entitled to the provisional application date of March 14, 2014. Notice at 1. For
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`the purpose of these proceedings, however, Patent Owners will not dispute that Wyse,
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`Davies, and Wang are all prior art. Thus, there is no need to institute a second petition
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`as a precaution, and Petitioner’s comment that different statutory provisions apply to
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`whether Wyse, Davies and Wang are prior art is moot. Notice at 1–2.
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`Petitioner also argues that the Petitions are non-redundant because Petitioner
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`has submitted a certified translation of Wang, rather than the machine translation that
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`1
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`was before the Examiner. Notice at 2. But Petitioner fails to point out any differences
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`Cases IPR2019-00691, -00692, and -00693
`Patent 9,561,177
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`between the translations, or how the way the various references were translated has
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`any bearing on the references’ substance. Petitioner’s translation argument is just a
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`convoluted way of stating the truism that the three Petitions do not cite exactly the
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`same references. This does not change the point that the Petitioner’s arguments are
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`substantially the same for each of the references.
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`When Petitioner finally turns to purported differences among its obviousness
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`arguments, it simply points to a few (unavailing) examples of purported differences,
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`making no effort to catalog “the similarities and differences” as the Board directed.
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`Order at 4. Petitioner does not deny the Petitions’ similarities—and that, in many
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`cases, they exhibit word-by-word sameness—on critical issues, including the volume
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`of the nasal spray, the naloxone dose, the choice of excipients (including BZK and
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`EDTA), etc. As a striking example, the Wang and Davies Petitions cite Wyse—not
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`Wang or Davies—for the dose limitation of all claims, which is likely to be a central
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`issue in any instituted proceedings. Wang Pet. at 20–21; Davies Pet. at 20–21.
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`Petitioner’s chart, Notice at 3, reflects that there are no issues which Petitioner
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`asserts are taught by Wang and Davies but not Wyse. In other words, according to
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`Petitioner, Wang and Davies are inferior references to Wyse. Petitioner argues that
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`the Wyse Petition relies on Wyse for the teaching of benzalkonium chloride (“BZK”),
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`while the other Petitions do not. Notice at 2–3. If true, this would merely
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`demonstrate the superiority of the Wyse Petition. But in fact, it is incorrect. All three
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`Cases IPR2019-00691, -00692, and -00693
`Patent 9,561,177
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`Petitions rely on HPE, not Wyse. The Wyse Petition concedes that “Wyse discloses
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`the preservative may be benzyl alcohol,” not BZK—and then proceeds to rely on
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`HPE for the teaching of BZK, Wyse Pet. at 35–36, as do the other two Petitions,
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`Wang Pet. at 34–36; Davies Pet. at 34–35. And the three Petitions contain the same
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`discussion about Wyse’s teaching on BZK—or, more precisely, teaching away—
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`verbatim. Wyse Pet. at 61–63; Wang Pet. at 63–65; Davies Pet. at 62–64.
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`Petitioner also argues that Wyse anticipates certain claim limitations relating
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`to device, pH, and plasma concentration, and that the other two primary references
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`do not. But the question is not whether the disclosures of the references are different
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`but rather whether “the Petitions rely on substantially overlapping grounds and
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`theories.” Order at 4. Critically, for these limitations, all three Petitions similarly
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`rely on Wyse. The Wang and Davies Petitions both cite to Wyse to demonstrate the
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`alleged obviousness of device, pH, and plasma concentration. See Wang Pet. at 22
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`(pH), 23 (device), 46–48 (plasma concentration), Davies Pet. at 23 (pH), 24 (device),
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`46–48 (plasma concentration). All Petitioner has established is that the disclosures
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`of Wang and Davies are even further removed from the claimed invention than that
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`of Wyse, and so Petitioner must bring in additional references to allege obviousness
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`in the Wang and Davies Petitions. That does not constitute a “rare” instance in which
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`two—let alone three—petitions may be needed. July 2019 TPG Update at 26.
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`Date: August 12, 2019
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`
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`Cases IPR2019-00691, -00692, and -00693
`Patent 9,561,177
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`Respectfully submitted,
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`/Jessamyn S. Berniker/
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`Jessamyn S. Berniker (Reg. No. 72,328)
`David M. Krinsky (Reg. No. 72,339)
`Anthony H. Sheh (Reg. No. 70,576)
`Williams & Connolly LLP
`725 Twelfth Street, N.W.
`Washington, DC 20005
`T: (202) 434-5000
`F: (202) 434-5029
`jberniker@wc.com
`dkrinsky@wc.com
`asheh@wc.com
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`Counsel for Patent Owner
`Adapt Pharma Limited
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`/Jessica Tyrus Mackay/
`Robert F. Green (Reg. No. 27,555)
`Jessica Tyrus Mackay (Reg. No. 64,742)
`GREEN, GRIFFITH & BORG-BREEN, LLP
`676 North Michigan Avenue
`Suite 3900
`Chicago, IL 60611
`(313) 883-8000
`jmackay@greengriffith.com
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`Counsel for Patent Owner
`Opiant Pharmaceuticals, Inc.
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`Cases IPR2019-00691, -00692, and -00693
`Patent 9,561,177
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`CERTIFICATE OF SERVICE
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`Pursuant to 37 C.F.R. § 42.6(e), the undersigned hereby certifies that a true
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`and correct copy of the foregoing was served on August 12, 2019, by delivering a
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`copy via electronic mail on the following attorneys of record:
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`Yelee Y. Kim
`Janine A. Carlan
`Richard Berman
`Bradford Frese
`Christopher Yaen
`ARENT FOX LLP
`1717 K Street NW
`Washington, DC 20036
`Yelee.Kim@arentfox.com
`Janine.Carlan@arentfox.com
`Richard.Berman@arentfox.com
`Bradford.Frese@arentfox.com
`Christopher.Yaen@arentfox.com
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`/Jessica Tyrus Mackay/
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`Jessica Tyrus Mackay (Reg. No. 64,742)
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