UNITED STATES PATENT AND TRADEMARK OFFICE
`__________________
`
`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 OPERATIONS LIMITED, and
`OPIANT PHARMACEUTICALS, INC.,
`Patent Owners.
`__________________
`
`Case IPR2019-00688
`U.S. Patent No. 9,468,747
`__________________
`
`PATENT OWNERS’ MOTION TO SEAL
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`__________________
`
`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
`__________________
`
`PATENT OWNERS’ MOTION TO SEAL
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`Pursuant to 35 U.S.C. § 316(a)(1) and 37 C.F.R. §§ 42.14 and 42.54, Patent
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`Owners Adapt Pharma Operations Limited (“Adapt”) and Opiant Pharmaceuticals,
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`Inc. (“Opiant”) hereby move to seal Exhibits 2098–2109, 2188, 2205, and 2207,
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`which are being filed concurrently with this Motion and Patent Owners’ Response.
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`I.
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`DOCUMENTS TO BE SEALED AND REASONS FOR SEALING
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`The standard governing the Board’s determination of whether to grant a
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`motion to seal is “good cause.” Garmin Int’l, Inc. v. Cuozzo Speed Techs LLC,
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`Case IPR2012-00001, Paper 36 at 4 (April 5, 2013) (quoting 37 C.F.R. § 42.54).
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`The Board aims to “strike a balance between the public’s interest in maintaining a
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`complete and understandable file history and the parties’ interest in protecting truly
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`sensitive information.” Id.
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`The exhibits and portions of exhibits that Patent Owners seek to file under
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`seal fall into three categories, each of which meets the “good cause” standard to be
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`maintained in the docket under seal and available only to the parties and Board. In
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`each instance, the material is either the confidential information of a third party
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`who has permitted its use in this proceeding subject to a protective order, or else
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`consists of confidential business information that would cause competitive harm to
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`Patent Owner Adapt were it to be disclosed publicly.
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`2
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`A. Confidential Third-Party Documents
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`Exhibit 2188 (“Indivior NDA Module 3.2.P.2”) was produced by third-party
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`Indivior, Inc. (“Indivior”) in response to a document subpoena in district court
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`litigation between Patent Owners and a pharmaceutical manufacturer that is not a
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`party to this IPR but seeks to make a generic naloxone product. Adapt Pharma
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`Operations Ltd. v. Teva Pharmaceuticals, USA, Inc., No. 2:16-cv-07221-BRM-
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`JAD; see Ex. 2194 subpoena). The document is part of the confidential New Drug
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`Application (“NDA”) submitted by Indivior to the U.S. Food and Drug
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`Administration (“FDA”), and it contains Indivior’s confidential business
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`information relating to its own proposed naloxone product. Although the
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`document was subject to a protective order in the litigation in which Indivior
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`originally produced it, Indivior has consented to its use in this proceeding provided
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`that it is filed under seal subject to the Board’s default protective order. See Ex.
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`2178 (email from Indivior counsel to Adapt counsel). Accordingly, there is good
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`cause for Exhibit 2188 to be maintained under seal.
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`B.
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`Financial Documents of Patent Owner Adapt
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`Exhibit 2205 (“Vigil Decl.”) and Exhibit 2207 (“Brides Decl.”) contain the
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`confidential financial information of Patent Owner Adapt and its corporate
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`affiliates. These exhibits contain certain financial information drawn from the
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`internal business records of Adapt, including the sales, by various metrics, of
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`3
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`Narcan® Nasal Spray on a quarterly and annual basis, and various costs associated
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`with Adapt’s activities in connection with Narcan® Nasal Spray. The information
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`is confidential business information that is not publicly available; it is
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`competitively sensitive and its inclusion in the public docket would cause
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`commercial harm to Adapt.
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`Exhibit 2205 is a declaration of Dr. Robert Vigil, an expert witness retained
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`by Patent Owners who addresses, inter alia, the commercial success of Narcan®
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`Nasal Spray. Dr. Vigil relies on the confidential financial information in
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`connection with his commercial success analysis, and Patent Owners move to seal
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`the specific portions of Dr. Vigil’s declaration that reveal the confidential financial
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`information. In accordance with Paragraph 5(A)(ii) of the Board’s Default
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`Protective Order, a redacted copy of Dr. Vigil’s declaration is being filed publicly
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`as Exhibit 2206.
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`Exhibit 2207 is a declaration of Mr. Declan Brides, Adapt’s Vice President,
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`Finance. Mr. Brides’s declaration and its appended Exhibit A contain the Adapt
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`confidential financial information described above; in addition, Mr. Brides’s
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`declaration describes the sources and methods Mr. Brides used to obtain that
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`financial information, including information about Adapt’s business operations that
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`is not publicly known. Because the recital and authentication of the Adapt
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`financial information—which is then analyzed and applied to the issues in the
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`4
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`
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`proceeding by Dr. Vigil—constitutes the bulk of the substantive portions of Mr.
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`Brides’s declaration, and appended Exhibit A is a spreadsheet consisting of
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`confidential information, Patent Owners move to seal Exhibit 2205 in its entirety.
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`In light of the confidential nature of the information in these documents and
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`the considerations discussed above, there is good cause to maintain this
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`information under seal.
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`C. Confidential Regulatory Documents Containing Confidential
`Formulation and Manufacturing Information
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`Exhibit 2098, Exhibit 2099, Exhibit 2100, Exhibit 2101, Exhibit 2102,
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`Exhibit 2103, Exhibit 2104, Exhibit 2105, Exhibit 2106, Exhibit 2107, Exhibit
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`2108, and Exhibit 2109 are portions of Adapt’s NDA for Narcan® Nasal Spray.
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`NDA materials are filed on a confidential basis with the U.S. Food and Drug
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`Administration. The portions of the NDA submitted here contain confidential
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`details of the formulation and manufacture of Patent Owners’ Narcan® Nasal
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`Spray product, and the public release of these documents could benefit Patent
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`Owners’ competitors (including competitors who may be seeking to copy Patent
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`Owners’ product) and thereby cause competitive harm to Patent Owners.
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`Exhibit 2201 (“Jones Decl.”) is a declaration of Dr. Stuart Jones, an expert
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`witness retained by Patent Owners who addresses, inter alia, whether Narcan®
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`Nasal Spray embodies the challenged claims. Dr. Jones relies on confidential
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`formulation and manufacturing information drawn from Adapt’s NDA in
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`5
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`
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`performing his analysis, and Patent Owners move to seal the specific portions of
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`Dr. Jones’s declaration that reveal that confidential information. In accordance
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`with Paragraph 5(A)(ii) of the Board’s Default Protective Order, a redacted copy of
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`Dr. Jones’s declaration is being filed publicly as Exhibit 2208.
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`Accordingly, Patent Owners move to seal these exhibits, and there is good
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`cause for them to be maintained under seal.
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`II.
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`PROPOSED PROTECTIVE ORDER
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`Pursuant to 37 CFR §§ 42.54 and 42.55(a), Patent Owners propose that the
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`Default Protective Order found in Appendix B of the Trial Practice Guide Update
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`(July 2019), available at https://www.uspto.gov/sites/default/files/documents/trial-
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`practice-guide-update3.pdf be entered.
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`III. CERTIFICATION
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`Pursuant to 37 CFR § 42.54, Patent Owners certify that they have conferred
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`with Petitioner regarding this motion to seal and the proposed protective order.
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`Petitioner does not object to the entry of the default protective order. Patent
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`Owners’ understanding is that Petitioner does not object to the motion to seal, but
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`reserves the right to do so once it has seen Patent Owners’ submissions.
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`Date: December 23, 2019
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`
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`Respectfully submitted,
`
`
`/Jessamyn S. Berniker/
`Jessamyn S. Berniker (Reg. No. 72,328)
`Ana C. Reyes (Admitted Pro Hac Vice)
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`6
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`
`
`
`
`
`
`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
`areyes@wc.com
`dkrinsky@wc.com
`asheh@wc.com
`
`Counsel for Patent Owner
`Adapt Pharma Operations Limited
`
`
`/Jessica Tyrus Mackay/
`Jessica Tyrus Mackay (Reg. No. 64,742)
`Ann K. Kotze (Reg. No. 76,570)
`GREEN, GRIFFITH & BORG-BREEN, LLP
`676 North Michigan Avenue, Suite 3900
`Chicago, IL 60611
`(313) 883-8000
`jmackay@greengriffith.com
`akotze@greengriffith.com
`
`Counsel for Patent Owner
`Opiant Pharmaceuticals, Inc.
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`7
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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 December 23, 2019, by delivering
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`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
`
`
`
`
`
`
`Jessamyn S. Berniker
`Ana C. Reyes
`David M. Krinsky
`Anthony H. Sheh
`WILLIAMS & CONNOLLY LLP
`725 Twelfth Street, N.W.
`Washington, DC 20005
`jberniker@wc.com
`areyes@wc.com
`dkrinsky@wc.com
`asheh@wc.com
`EmergentNarcan@wc.com
`
`Jessica Tyrus Mackay
`Ann K. Kotze
`GREEN, GRIFFITH & BORG-BREEN, LLP
`676 North Michigan Avenue
`Suite 3900
`Chicago, IL 60611
`jmackay@greengriffith.com
`akotze@greengriffith.com
`
`/Jessamyn S. Berniker/
`Jessamyn S. Berniker
`Reg. No. 72,328
`
`
`
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`8
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