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`Case IPR2022-00722
`U.S. Patent No. 7,041,786
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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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`MYLAN PHARMACEUTICALS INC.,
`MSN LABORATORIES PRIVATE LTD.,
`and MSN PHARMACEUTICALS INC.,
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`Petitioner,
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`v.
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`BAUSCH HEALTH IRELAND LIMITED,
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`Patent Owner.
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`__________________
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`Case IPR2022-007221
`U.S. Patent No. 7,041,786
`__________________
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`PATENT OWNER’S MOTION TO SEAL
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`1 IPR2023-00016 has been joined with this proceeding.
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`Introduction
`Patent Owner Bausch Health Ireland Limited requests that the confidential
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`Case IPR2022-00722
`U.S. Patent No. 7,041,786
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`I.
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`versions of Petitioner’s Reply and Exhibits 1060, 1063 and 1064 be sealed under 37
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`C.F.R. § 42.54. Good cause to seal these documents exists because a public version
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`of Petitioner’s Reply and Exhibits 1060, 1063 and 1064 have also been filed, and the
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`redacted information is sensitive, non-public excerpts of Bausch’s New Drug
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`Application (“NDA”). Petitioner indicated that it will reserve any position on the
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`merits of this motion until it has an opportunity to review the motion.
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`II. Governing Rules and PTAB Guidance
`Under 35 U.S.C. § 316(a)(1), the default rule is that all papers filed in an inter
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`partes review are open and available for access by the public, but a party may file a
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`concurrent motion to seal and the information at issue is sealed pending the outcome
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`of the motion.
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`Similarly, 37 C.F.R. § 42.14 provides:
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`The record of a proceeding, including documents and things,
`shall be made available to the public, except as otherwise
`ordered. A party intending a document or thing to be sealed
`shall file a motion to seal concurrent with the filing of the
`document or thing to be sealed. The document or thing shall be
`provisionally sealed on receipt of the motion and remain so
`pending the outcome of the decision on the motion.
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`It is, however, only “confidential information” that is protected from disclosure. 35
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`Case IPR2022-00722
`U.S. Patent No. 7,041,786
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`U.S.C. § 316(a)(7) (“The Director shall prescribe regulations -- . . . providing for
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`protective orders governing the exchange and submission of confidential
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`information”). In that regard, the Office Trial Practice Guide, 77 Fed. Reg. 48756,
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`48760 (Aug. 14, 2012) provides:
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`The rules aim to strike a balance between the public’s interest
`in maintaining a complete and understandable file history and
`the parties’ interest in protecting truly sensitive information.
`* * *
`Confidential Information: The rules identify confidential
`information in a manner consistent with Federal Rule of Civil
`Procedure 26(c)(1)(G), which provides for protective orders for
`trade secret or other confidential research, development, or
`commercial information. § 42.54.
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`Identification of Confidential Information
`The confidential information consists of non-public excerpts of Bausch’s
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`III.
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`NDA. This information is contained in the following documents:
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`• Petitioner’s Reply in pages 24-28
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`• Exhibit 1060 in pages 38-50, 53-61, and 63-85
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`• Exhibit 1063 in pages 80, 82-101, 110-111, 116-118, and 120-121
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`• Exhibit 1064 in page 23
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`2
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`IV. Good Cause Exists for Sealing the Confidential Information
`The Board’s rules identify confidential information in a manner consistent
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`Case IPR2022-00722
`U.S. Patent No. 7,041,786
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`with Federal Rule of Civil Procedure 26(c)(1)(G), which provides for protective
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`orders for trade secret or other confidential research, development, or commercial
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`information. Office Patent Trial Practice Guide, 77 Fed. Reg. 48,756, 48,760 (Aug.
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`14, 2012). Accordingly, the Board has recognized that New Drug Applications and
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`Abbreviated New Drug Applications contain confidential commercial information
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`that should be protected from public disclosure. See Sandoz, Inc. v. EKR
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`Therapeutics, LLC, IPR2015-00005, paper 21. Here, the information that Patent
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`Owner seeks to seal is information contained in Bausch’s NDA, which was filed
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`confidentially with the Food and Drug Administration (“FDA”) in order to obtain
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`FDA approval to market its innovative pharmaceutical product. Specifically, Patent
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`Owner seeks to seal the portions of the Petitioner’s Reply, pages 24-28; Exhibit 1060
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`pages 38-50, 53-61, and 63-85; Exhibit 1063, pages 80, 82-101, 110-111, 116-118,
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`and 120-121; and Exhibit 1064, page 23 that cite or substantially describe the NDA.
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`Accordingly, there is good cause to grant this Motion to Seal.
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`III. Certification of Non-publication
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`The undersigned counsel certifies that the information sought to be sealed by
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`this Motion to Seal has not, to their knowledge, been published or otherwise made
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`public. Patent Owner has made efforts to maintain the confidentiality of this
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`3
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`information in a related district court proceeding. In that district court proceeding,
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`Case IPR2022-00722
`U.S. Patent No. 7,041,786
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`the information that Patent Owner presently moves to seal has been produced and
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`designated “Highly Confidential Information.”
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`IV. Conclusion
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`For the reasons set forth above, Patent Owner respectfully requests the Board
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`grant this Motion to Seal.
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`Date: May 10, 2023
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`Respectfully submitted,
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`/ Justin J. Hasford /
`By:
`Justin J. Hasford, Reg. No. 62,180
`Lead Counsel
`Bryan C. Diner, Reg. No. 32,409
`Back-up Counsel
`Joshua L. Goldberg, Reg. No. 59,369
`Back-up Counsel
`Kassandra M. Officer Reg. No. 74,083
`Back-up Counsel
`Lauren J. Robinson Reg. No. 74,100
`Back-up Counsel
`Caitlin E. O’Connell, Reg. No. 73,934
`Back-up Counsel
`Kyu Yun Kim, Reg. No. 72,783
`Back-up Counsel
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`FINNEGAN, HENDERSON, FARABOW,
`GARRETT & DUNNER, L.L.P.
`901 New York Ave. NW
`Washington, DC 20001-4413
`(202) 408-4000
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`Counsel for Patent Owner
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`U.S. Patent No. 7,041,786
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`CERTIFICATE OF SERVICE
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`The undersigned certifies that a copy of the foregoing PATENT OWNER’S
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`MOTION TO SEAL was served electronically via email on May 10, 2023 to counsel
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`of record for the Petitioner at the following:
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`Jad A. Mills
`Wilson Sonsini Goodrich & Rosati PC
`701 Fifth Avenue, Suite 5100
`Seattle, WA 98104-7036
`jmills@wsgr.com
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`Richard Torczon
`Tasha M. Thomas
`Wilson Sonsini Goodrich & Rosati PC
`1700 K Street N.W., 5th Floor
`Washington, DC 20006
`rtorczon@wsgr.com
`tthomas@wsgr.com
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`Dennis D. Gregory
`Wilson Sonsini Goodrich & Rosati PC
`900 South Capital of Texas Highway, Las Cimas IV, Fifth Floor
`Austin, TX 78746-5546
`dgregory@wsgr.com
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`4863-5899-2145@mail.vault.netdocuments.com
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`Andrew O. Larsen
`Merchant & Gould, P.C.
`500 Fifth Avenue, Suite 4100
`New York, NY 10110
`alarsen@merchantgould.com
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`Melissa Hayworth
`Merchant & Gould, P.C.
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`Case IPR2022-00722
`U.S. Patent No. 7,041,786
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`1900 Duke, Street, Suite 600
`Alexandria, VA 22314
`mhayworth@merchantgould.com
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`Christopher J. Sorenson
`Merchant & Gould, P.C.
`150 South Fifth Street, Suite 2200
`Minneapolis, MN 55402
`csorenson@merchantgould.com
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`plecanatidemerchant@merchantgould.com
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`By: /Geneva Eaddy/
`Geneva Eaddy
`Case Manager
`FINNEGAN, HENDERSON, FARABOW,
`GARRETT & DUNNER, LLP
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`Date: May 10, 2023
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