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`Case No. IPR2022-01104
`U.S. Patent No. 9,919,024
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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.,
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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 IPR2022-01104
`U.S. Patent No. 9,919,024
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`PATENT OWNER’S MOTION TO SEAL AND
`ENTER DEFAULT PROTECTIVE ORDER
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`I.
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`Case No. IPR2022-01104
`U.S. Patent No. 9,919,024
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`Introduction
`Patent Owner Bausch Health Ireland Limited requests that the confidential
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`versions of the Patent Owner’s Preliminary Response and Exhibit 2013 be sealed
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`under 37 C.F.R. § 42.54. Good cause to seal these documents exists because a public
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`version of the Patent Owner’s Preliminary Response has also been filed, and the
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`redacted information, along with the entirety of the information in Exhibit 2013, is
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`sensitive, non-public excerpts of Bausch’s New Drug Application (“NDA”) 208745.
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`Petitioner does not oppose this motion to seal or the entry of the default protective
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`order, provided that Petitioner may seek additional restrictions to the default order
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`if Petitioner’s confidential information is proposed to be submitted later.
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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
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`Case No. IPR2022-01104
`U.S. Patent No. 9,919,024
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`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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`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.
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`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 208745. This information is contained in the following documents:
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`• Patent Owner’s Preliminary Response in pages 10, 64, 65.
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`• Exhibit 2013
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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 No. IPR2022-01104
`U.S. Patent No. 9,919,024
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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 208745, which was
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`filed confidentially with the Food and Drug Administration (“FDA”) in order to
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`obtain FDA approval to market its innovative pharmaceutical product. Specifically,
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`Patent Owner seeks to seal the entirety of Exhibit 2013 because it is excerpts of the
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`NDA, the entirety of which is confidential, and redaction would not be practical. In
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`addition, Patent Owner seeks to seal the portions of the Patent Owner’s Preliminary
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`Response, pages 10, 64, 65, that cite or substantially describe the NDA. Accordingly,
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`there is good cause to grant this motion to seal.
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`III. PROPOSED PROTECTIVE ORDER
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`Pursuant to 37 C.F.R. § 42.54(a), the parties propose that the default
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`protective order found in Appendix B of the Trial Practice Guide be entered.
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`IV. CERTIFICATION OF NON-PUBLICATION
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`Case No. IPR2022-01104
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`The undersigned counsel certifies the information sought to be sealed by this
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`Motion to Seal has not, to their knowledge, been published or otherwise made public.
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`Patent Owner has made efforts to maintain the confidentiality of this information in
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`a related district court proceeding. In that district court proceeding, the information
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`that Patent Owner presently moves to seal has been produced and designated
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`“Highly Confidential Information.”
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`V. 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 and enter the default Protective Order.
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`Dated: October 7, 2022
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`Respectfully submitted,
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`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
`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.
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`Case No. IPR2022-01104
`U.S. Patent No. 9,919,024
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`901 New York Ave. NW
`Washington, DC 20001-4413
`(202) 408-4000
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`Counsel for the Patent Owner
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`Case No. IPR2022-01104
`U.S. Patent No. 9,919,024
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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 AND ENTER DEFAULT PROTECTIVE ORDER was
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`served electronically via email on October 7, 2022, in their entirety on the
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`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
`4863-5899-2145@mail.vault.netdocuments.com
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`Richard Torczon
`Wilson Sonsini Goodrich & Rosati PC
`1700 K Street N.W., 5th Floor
`Washington, DC 20006
`rtorczon@wsgr.com
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`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
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`The Petitioner has consented to service by electronic mail.
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`By: /Geneva Eaddy/
`Geneva Eaddy
`Case Manager
`FINNEGAN, HENDERSON, FARABOW,
`GARRETT & DUNNER, LLP
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`Date: October 7, 2022
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