`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`__________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`__________________
`
`NALOX-1 PHARMACEUTICALS, LLC,
`Petitioner,
`
`v.
`
`ADAPT PHARMA LIMITED, and
`OPIANT PHARMACEUTICALS, INC.,
`Patent Owners.
`__________________
`
`Cases IPR2019-00697, IPR 2019-00698, and IPR 2019-00699
`Patent 9,775,838
`__________________
`
`PATENT OWNERS’ RESPONSE TO PETITIONER’S NOTICE
`
`
`
`
`
`
`
`
`Cases IPR2019-00697, -00698, and -00699
`Patent 9,775,838
`
`Petitioner’s Notice confirms that the Wang and Davies Petitions are redundant
`
`
`
`of the Wyse Petition. Like Patent Owners, Petitioner ranks the Wyse Petition
`
`(IPR2019-00697) first, ahead of the Wang and Davies Petitions (-00698 and -00699).
`
`Petitioner largely dodges the Board’s request for an explanation of the
`
`differences among the Petitions. Petitioner’s handful of examples of alleged
`
`differences largely boil down to reasons why Wang and Davies teach fewer claim
`
`limitations and are even weaker references than Wyse. As Patent Owners explained
`
`in their Preliminary Responses, all three Petitions have fatal deficiencies. In addition,
`
`the district court trial related to these Petitions is scheduled to start in two weeks. The
`
`Board should thus decline to institute any of these IPR proceedings. But if the Board
`
`institutes anything, it should institute only the Wyse Petition.
`
`First, Petitioner asserts that the Wyse Petition presents different issues because
`
`Wyse may not be prior art if the claims that were ultimately granted in the ’838 patent
`
`are entitled to the provisional application date of March 14, 2014. Notice at 1. For
`
`the purpose of these proceedings, however, Patent Owners will not dispute that Wyse,
`
`Davies, and Wang are all prior art. Thus, there is no need to institute a second petition
`
`as a precaution, and Petitioner’s comment that different statutory provisions apply to
`
`whether Wyse, Davies and Wang are prior art is moot. Notice at 1–2.
`
`Petitioner also argues that the Petitions are non-redundant because Petitioner
`
`has submitted a certified translation of Wang, rather than the machine translation that
`
`1
`
`
`
`
`was before the Examiner. Notice at 2. But Petitioner fails to point out any differences
`
`Cases IPR2019-00697, -00698, and -00699
`Patent 9,775,838
`
`between the translations or how the way the various references were translated has
`
`any bearing on the references’ substance. Petitioner’s translation argument is just a
`
`convoluted way of stating the truism that the three Petitions do not cite exactly the
`
`same references. This does not change the point that the Petitioner’s arguments are
`
`substantially the same for each of the references.
`
`When Petitioner finally turns to purported differences among its obviousness
`
`arguments, it simply points to a few (unavailing) examples of purported differences,
`
`making no effort to catalog “the similarities and differences” as the Board directed.
`
`Order at 4. Petitioner does not deny the Petitions’ similarities—and that, in many
`
`cases, they exhibit word-by-word sameness—on critical issues, including the volume
`
`of the nasal spray, the naloxone dose, the choice of excipients (including BZK and
`
`EDTA), etc. As a striking example, the Wang and Davies Petitions cite Wyse—not
`
`Wang or Davies—for the dose limitation of all claims, which is likely to be a central
`
`issue in any instituted proceedings. Wang Pet. at 18–19; Davies Pet. at 18–19.
`
`Petitioner’s chart, Notice at 3, reflects that there are no issues which Petitioner
`
`asserts are taught by Wang and Davies but not Wyse. In other words, according to
`
`Petitioner, Wang and Davies are inferior references to Wyse. According to
`
`Petitioner, the Wyse Petition relies on Wyse for the teaching of benzalkonium
`
`chloride (“BZK”), while the other Petitions do not. See Notice at 2–3. If true, this
`
`2
`
`
`
`
`would merely demonstrate the superiority of the Wyse Petition. But in fact, it is
`
`Cases IPR2019-00697, -00698, and -00699
`Patent 9,775,838
`
`incorrect. All three Petitions rely on HPE, not Wyse. The Wyse Petition concedes
`
`that “Wyse discloses the preservative may be benzyl alcohol”—not BZK—and then
`
`proceeds to rely on HPE for the teaching of BZK, id. at 33–35, as do the other two
`
`Petitions, Wang Pet. at 32–33; Davies Pet. at 31–32. And the three Petitions contain
`
`the same discussion on Wyse’s teaching on BZK—or, more precisely, teaching
`
`away—verbatim. Wyse Pet. at 61–63; Wang Pet. at 62–64; Davies Pet. at 62–64.
`
`Petitioner also argues that Wyse anticipates certain claim limitations relating
`
`to device, pH, disodium edetate, and plasma concentration, and that the other two
`
`primary references do not. But the question is not whether the disclosures of the
`
`references are different but rather whether “the Petitions rely on substantially
`
`overlapping grounds and theories.” Order at 4. Critically, for these limitations, all
`
`three Petitions similarly rely on Wyse. The Wang and Davies Petitions both cite to
`
`Wyse to demonstrate the alleged obviousness of device, pH, disodium edetate, and
`
`plasma concentration. See Wang Pet. at 20–21, 61–62; Davies Pet. at 20–21, 61–62.
`
`All Petitioner has established is that the disclosures of Wang and Davies are even
`
`further removed from the claimed invention than that of Wyse, and so Petitioner must
`
`bring in additional references to allege obviousness in the Wang and Davies Petitions.
`
`That does not constitute a “rare” instance in which two—let alone three—petitions
`
`may be needed. July 2019 TPG Update at 26.
`
`3
`
`
`
`
`Date: August 12, 2019
`
`
`
`Cases IPR2019-00697, -00698, and -00699
`Patent 9,775,838
`
`Respectfully submitted,
`
`/Jessamyn S. Berniker/
`
`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
`
`Counsel for Patent Owner
`Adapt Pharma Limited
`
`
`/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
`
`Counsel for Patent Owner
`Opiant Pharmaceuticals, Inc.
`
`
`
`
`
`
`
`
`4
`
`
`
`Cases IPR2019-00697, -00698, and -00699
`Patent 9,775,838
`
`CERTIFICATE OF SERVICE
`
`Pursuant to 37 C.F.R. § 42.6(e), the undersigned hereby certifies that a true
`
`
`
`
`
`and correct copy of the foregoing was served on August 12, 2019, by delivering a
`
`copy via electronic mail on the following attorneys of record:
`
`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
`
`
`
`/Jessica Tyrus Mackay/
`
`Jessica Tyrus Mackay (Reg. No. 64,742)
`
`
`
`
`
`
`
`
`
`5
`
`
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