`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`__________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`__________________
`
`
`MYLAN PHARMACEUTICALS INC.,
`
`Petitioner,
`
`v.
`
`BAUSCH HEALTH IRELAND LIMITED,
`
`Patent Owner.
`
`__________________
`
`Case IPR2022-01104
`U.S. Patent No. 9,919,024
`__________________
`
`PATENT OWNER’S MOTION TO EXPUNGE CONFIDENTIAL
`INFORMATION
`
`
`
`
`
`I.
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`Case IPR2022-01104
`Patent No. 9,919,024
`
`Introduction
`Pursuant to 37 C.F.R. § 42.56, Patent Owner, Bausch Health Ireland Limited
`
`(“Patent Owner” or “Bausch”), hereby requests that certain confidential information
`
`in the record be expunged for the reasons set forth below.
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`Specifically, Bausch respectfully requests that the following paper and
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`document currently under seal be expunged from the record as this paper and
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`document contain Bausch’s highly confidential information:
`
`• Exhibit 2013: Final Clinical Study Report SP304101-08 (excerpt)
`CONFIDENTIAL
`
`• Paper 7: Patent Owner’s Preliminary Response (CONFIDENTIAL)
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`II. Applicable Legal Standards
`37 C.F.R. § 42.56 provides that following “denial of a petition to institute a
`
`trial or after final judgment in a trial, a party may file a motion to expunge
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`confidential information from the record.” Similarly, the Trial Practice Guide states
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`“[t]here is an expectation that information will be made public where the existence
`
`of the information is referred to in a decision to grant or deny a request to institute a
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`review or is identified in a final written decision following trial.” 2019 Office
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`Consolidated Trial Practice Guide1 at 21-22. However, the Trial Practice Guide also
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`states that a party “seeking to maintain the confidentiality of information . . . may
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`1 Available at https://www.uspto.gov/TrialPracticeGuideConsolidated.
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`1
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`
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`file a motion to expunge the information from the record prior to the information
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`Case IPR2022-01104
`Patent No. 9,919,024
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`becoming public.” Id. A party seeking expungement from the record must show
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`good cause by demonstrating “that any information sought to be expunged
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`constitutes confidential information, and that [a party’s] interest in expunging it
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`outweighs the public’s interest in maintain a complete and understandable history of
`
`this inter partes review.” Atlanta Gas Light Co. v. Bennett Regulator Guards, Inc.,
`
`IPR2013-00453, Paper 97 at (P.T.A.B. Apr. 15, 2015).
`
`III. Good Cause Exists to Expunge Exhibit 2013 and Paper 7 from the Record
`In this proceeding, the Board granted Patent Owner’s Motion to Seal Exhibit
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`2013 (excerpts of Patent Owner’s New Drug Application 208745), and the portions
`
`of Patent Owner’s Preliminary Response (on pages 10, 64, and 65) “that cite or
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`substantially describe” the content of Exhibit 2013. Paper 15 at 22. In its Order, the
`
`Board concluded “that Patent Owner has established good cause to seal its
`
`confidential information” and granted its Motion to Seal. Paper 15 at 21-22.
`
`Redacted versions of the now-sealed Exhibit 2013 and Paper 7 were provided
`
`and are currently available to the public. Specifically, the following table
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`summarizes the confidential, sealed documents (left column) and the corresponding
`
`redacted versions that are currently publicly available (right column):
`
`2
`
`
`
`Case IPR2022-01104
`Patent No. 9,919,024
`
`Sealed Document
`
`Redacted Version of Document
`
`Ex. 2013: Final Clinical Study Report
`
`Ex. 2013: Final Clinical Study Report
`
`SP304101-08 (excerpt) CONFIDENTIAL
`
`SP304101-08 (excerpt) PUBLIC
`
`Paper 7: Patent Owner’s Preliminary
`
`Paper 8: Patent Owner’s Preliminary
`
`Response (CONFIDENTIAL)
`
`Response (Public Version)
`
`As set forth in Patent Owner’s Motion to Seal, the highly confidential, now-
`
`
`
`
`
`sealed documents contain information from Bausch’s NDA 208745, 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 Bausch’s Trulance® drug product. Further, the Board’s
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`rules identify confidential information in a manner consistent with Federal Rule of
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`Civil Procedure 26(c)(1)(G), which provides for protective orders for trade secret or
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`other confidential research, development, or commercial information. 2019 Office
`
`Consolidated Trial Practice Guide at 19. The Board has accordingly recognized that
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`New Drug Applications and Abbreviated New Drug Applications contain
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`confidential commercial information that should be protected from public
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`disclosure. See Sandoz Inc. v. EKR Therapeutics, LLC, IPR2015-00005, Paper 21
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`(PTAB Apr. 24, 2014).
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`
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`Patent Owner submits that it would be placed in a competitive and strategic
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`disadvantage should the confidential information related to its New Drug
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`3
`
`
`
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`Application become public. Additionally, redacted versions of the highly
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`Case IPR2022-01104
`Patent No. 9,919,024
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`confidential documents have been filed publicly in the present proceeding. These
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`redacted versions “maintain the essence” of non-confidential material contained
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`within the paper and document and thus allow the public to “maintain[] a complete
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`and understandable history” of the present proceeding. Atlanta Gas Light, Paper 97
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`at 2-3. The Board also did not cite anything exclusively in the confidential
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`documents in its decision denying institution of the inter partes review. See
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`generally Paper 15. Accordingly, the public interest would be served by maintaining
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`the confidentiality of this information.
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`
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`Therefore, good cause exists to expunge Exhibit 2013 and Paper 7.
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`IV. Conclusion
`For the above reasons, Patent Owner respectfully requests that the Board
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`protect Patent Owner’s highly confidential information and expunge Exhibit 2013
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`and Paper 7 pursuant to 37 C.F.R. § 42.56.
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`V. Request for Call with the Board
`Should the Board not be inclined to grant the present Motion to Expunge,
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`Patent Owner hereby requests a conference call with the Board to discuss any
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`concerns prior to the Board issuing a decision on the Motion.
`
`4
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`
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`Dated: February 13, 2023
`
`Case IPR2022-01104
`Patent No. 9,919,024
`
`
`
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`
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`Respectfully submitted,
`
`
`By: /Justin J. Hasford/
`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
`
`FINNEGAN, HENDERSON, FARABOW,
`GARRETT & DUNNER, L.L.P.
`901 New York Ave. NW
`Washington, DC 20001-4413
`(202) 408-4000
`
`Counsel for Patent Owner
`
`
`
`5
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`
`
`
`
`CERTIFICATE OF SERVICE
`
`Case IPR2022-01104
`Patent No. 9,919,024
`
`The undersigned hereby certifies that a copy of the foregoing Patent Owner’s
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`Motion to Expunge Confidential Information were served electronically via email
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`on February 13, 2023 to counsel of record for the Petitioner at the following:
`
`Jad A. Mills
`Wilson Sonsini Goodrich & Rosati PC
`701 Fifth Avenue, Suite 5100
`Seattle, WA 98104-7036
`jmills@wsgr.com
`
`Richard Torczon
`Wilson Sonsini Goodrich & Rosati PC
`1700 K Street N.W., 5th Floor
`Washington, DC 20006
`rtorczon@wsgr.com
`
`Nicole W. Stafford
`Dennis D. Gregory
`Wilson Sonsini Goodrich & Rosati PC
`900 South Capital of Texas Highway, Las Cimas IV, Fifth Floor
`Austin, TX 78746-5546
`nstafford@wsgr.com
`dgregory@wsgr.com
`
`4876-6223-0546@mail.vault.netdocuments.com
`
`
`
`By: /Geneva Eaddy/
`Geneva Eaddy
`Case Manager
`FINNEGAN, HENDERSON, FARABOW,
`GARRETT & DUNNER, LLP
`
`Date: February 13, 2023
`
`
`
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