throbber

`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`__________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`__________________
`
`NALOX-1 PHARMACEUTICALS, LLC,
`Petitioner,
`
`v.
`
`OPIANT PHARMACEUTICALS, INC.,
`Patent Owner.
`__________________
`
`Cases IPR2019-00688, IPR 2019-00689, and IPR 2019-00690
`Patent 9,468,747
`__________________
`
`PATENT OWNER’S RESPONSE TO PETITIONER’S NOTICE
`
`
`
`
`
`
`

`

`Cases IPR2019-00688, -00689, and -00690
`Patent 9,468,747
`
`Petitioner’s Notice confirms that the Wang and Davies Petitions are redundant
`
`
`
`of the Wyse Petition. Like Patent Owner, Petitioner ranks the Wyse Petition
`
`(IPR2019-00688) first, ahead of the Wang and Davies Petitions (-00689 and -00690).
`
`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 Owner explained
`
`in its 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 ’747 patent
`
`are entitled to the provisional application date of March 14, 2014. Notice at 1. For
`
`the purpose of these proceedings, however, Patent Owner 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 IPR2019-00688, -00689, and -00690
`Patent 9,468,747
`
`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. For example, the Wang and Davies Petitions cite Wyse—not Wang or
`
`Davies—for the dose limitation of all claims. Wang Pet. at 18–19; Davies Pet. at 17.
`
`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
`
`would merely demonstrate the superiority of the Wyse Petition. But in fact, it is
`
`2
`
`

`

`
`incorrect. All three Petitions rely on HPE, not Wyse. The Wyse Petition states that
`
`Cases IPR2019-00688, -00689, and -00690
`Patent 9,468,747
`
`“Wyse does not specifically identify . . . the types of antimicrobial agents that may
`
`be used.” Wyse Pet. at 33 (emphasis added). It then proceeds to rely on HPE for the
`
`teaching of BZK, id. at 33–34, 36–37, as do the other two Petitions, see Wang Pet. at
`
`32; Davies Pet. at 30–31. And the three Petitions contain the same discussion on
`
`Wyse’s teaching on BZK—or, more precisely, teaching away—verbatim. Wyse Pet.
`
`at 58–60; Wang Pet. at 60–61; Davies Pet. at 60–62.
`
`Petitioner also argues that Wyse anticipates certain claim limitations relating
`
`to device, pH, isotonicity agent, 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, isotonicity agent, and
`
`plasma concentration. See Wang Pet. at 20, 21, 53–54; Davies Pet. at 19, 21, 45–47.
`
`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 IPR2019-00688, -00689, and -00690
`Patent 9,468,747
`
`
`
`Respectfully submitted,
`
`/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 IPR2019-00688, -00689, and -00690
`Patent 9,468,747
`
`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
`
`

This document is available on Docket Alarm but you must sign up to view it.


Or .

Accessing this document will incur an additional charge of $.

After purchase, you can access this document again without charge.

Accept $ Charge
throbber

Still Working On It

This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.

Give it another minute or two to complete, and then try the refresh button.

throbber

A few More Minutes ... Still Working

It can take up to 5 minutes for us to download a document if the court servers are running slowly.

Thank you for your continued patience.

This document could not be displayed.

We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.

Your account does not support viewing this document.

You need a Paid Account to view this document. Click here to change your account type.

Your account does not support viewing this document.

Set your membership status to view this document.

With a Docket Alarm membership, you'll get a whole lot more, including:

  • Up-to-date information for this case.
  • Email alerts whenever there is an update.
  • Full text search for other cases.
  • Get email alerts whenever a new case matches your search.

Become a Member

One Moment Please

The filing “” is large (MB) and is being downloaded.

Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.

Your document is on its way!

If you do not receive the document in five minutes, contact support at support@docketalarm.com.

Sealed Document

We are unable to display this document, it may be under a court ordered seal.

If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.


Access Government Site

We are redirecting you
to a mobile optimized page.





Document Unreadable or Corrupt

Refresh this Document
Go to the Docket

We are unable to display this document.

Refresh this Document
Go to the Docket