`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_____________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________________
`
`
`NALOX-1 PHARMACEUTICALS, LLC,
`Petitioner,
`v.
`ADAPT PHARMA OPERATIONS LIMITED, AND
`OPIANT PHARMACEUTICALS, INC.
`Patent Owners.
`_____________________
`
`CASE IPR2019-00688
`U.S. Patent No. 9,468,747
`_____________________
`
`PETITIONER NALOX-1 PHARMACEUTICALS, LLC’s
`REQUEST FOR ORAL ARGUMENT
`
`
`
`
`
`
`
`
`IPR2019-00688 – U.S. Patent No. 9,468,747
` Petitioner’s Request for Oral Argument
`
`Pursuant to 37 C.F.R. § 42.70(a) and the Scheduling Order entered on
`
`
`
`September 9, 2019, and the Conduct of Proceedings Order entered on November
`
`25, 2019, Petitioner Nalox-1 Pharmaceuticals, LLC (“Petitioner”) respectfully
`
`requests oral argument on May 19, 2020. Petitioner proposes (and Patent Owners
`
`agree) that the Board conduct a consolidated proceeding in Inter Partes Review
`
`Nos. IPR2019-00685, -00688, and -00694, as well as any matters joined therewith,
`
`as these cases all are scheduled for hearing on the same date, relate to related
`
`patents, and the challenge is on identical art.
`
`For these proceedings, the parties have agreed that Petitioner will have a
`
`total of forty-five (45) minutes to present its arguments, including time to be
`
`reserved for rebuttal, and that Patent Owners will have a total of forty-five (45)
`
`minutes to present its responsive arguments, subject to approval by the Board.
`
`The parties will exchange demonstrative exhibits seven (7) business days in
`
`advance of the oral hearing in accordance with 37 C.F.R. § 42.70(b). The parties
`
`have agreed that any demonstratives will address the issues for all three of
`
`IPR2019-00685, -00688, and -00694 per side, and that any references to exhibits
`
`and papers will be made to the exhibits and papers filed in IPR2019-00688 for
`
`issues common across all IPRs, except that references to other proceedings’
`
`pleadings and exhibits may be made only when necessary to address issues specific
`
`to those proceedings.
`
`
`
`
`
`IPR2019-00688 – U.S. Patent No. 9,468,747
` Petitioner’s Request for Oral Argument
`
`Without waiving any issue not specifically listed below, Petitioner identifies
`
`the following issues to be argued at the May 19, 2020 hearing:
`
`1) Whether it would have been obvious to a person of ordinary skill in
`
`the art (“POSA”) to use benzalkonium chloride (“BAC”) in an intranasal naloxone
`
`formulation;
`
`2) Whether the claimed dose of 4 mg of naloxone hydrochloride would
`
`have been obvious to a POSA;
`
`3) Whether any evidence of secondary considerations supports
`
`patentability, including the following:
`
`a. Unexpected results;
`
`b. Skepticism;
`
`c. Failure of others;
`
`d. Long-felt but unresolved need; and
`
`e. Commercial success.
`
`4)
`
`Arguments and evidence presented in any motions to exclude
`
`evidence or response thereto.
`
`5)
`
`Any other issues that the Board deems necessary to issue a final
`
`written decision.
`
`Petitioner
`
`requests
`
`the use of audio/visual equipment
`
`to display
`
`demonstrative exhibits, including the use of a document camera or “Elmo,” and a
`
`2
`
`
`
`IPR2019-00688 – U.S. Patent No. 9,468,747
` Petitioner’s Request for Oral Argument
`
`computer/projector/screen system. In accordance with Trial Practice Guide, 77
`
`Fed. Reg. at 48768, Petitioner will work with the Board Trial Division regarding
`
`this request.
`
`
`
`3
`
`
`
`Date: April 6, 2020
`
`
`
`
`
`IPR2019-00688 – U.S. Patent No. 9,468,747
` Petitioner’s Request for Oral Argument
`
`
`
`
`Respectfully submitted,
`
`
`
`
`
`/s/ Yelee Y. Kim
`Yelee Y. Kim, Reg. No. 60,088
`ARENT FOX LLP
`1717 K Street, NW
`Washington, DC 20006
`202.857.6000
`Counsel for Petitioner
`Nalox-1 Pharmaceuticals, LLC
`
`
`
`4
`
`
`
`IPR2019-00688 – U.S. Patent No. 9,468,747
` Certificate of Service
`
`
`CERTIFICATION OF SERVICE (37 C.F.R. §§ 42.6(e), 42.105(a))
`The undersigned hereby certifies that the above-captioned “Petitioner Nalox-
`
`1 Pharmaceuticals, LLC’s Request for Oral Argument,” was served in its entirety
`
`on April 6, 2020, upon the following parties via e-mail:
`
`Jessamyn S. Berniker (jberniker@wc.com)
`Ana C. Reyes (areyes@wc.com)
`David M. Krinsky (dkrinsky@wc.com)
`Anthony H. Sheh (asheh@wc.com)
`WILLIAMS & CONNOLLY LLP
`725 Twelfth Street, NW
`Washington, DC 20005
`(202) 434-5000
`Counsel for Patent Owner
`Adapt Pharma Operations Limited
`
`Jessica Tyrus Mackay (jmackay@greengriffith.com)
`Ann K. Kotze (akotze@greengriffith.com)
`GREEN, GRIFFITH & BORG-BREEN, LLP
`676 North Michigan Avenue, Suite 3900
`Chicago, IL 60611
`(313) 883-8000
`Counsel for Patent Owner
`Opiant Pharmaceuticals, Inc.
`
`
`
`
`
`
`
`
`
`
`
`/s/ Yelee Y. Kim
`Yelee Y. Kim, Reg. No. 60,088
`ARENT FOX LLP
`1717 K Street, NW
`Washington, D.C. 20006
`(202) 857-6000
`yelee.kim@arentfox.com
`
`
`
`Counsel for Petitioner
`Nalox-1 Pharmaceuticals, LLC
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
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