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`Paper No. 7
`Filed: June 29, 2022
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`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 IPR2022-00722
`U.S. Patent No. 7,041,786
`__________________
`
`PATENT OWNER’S EXHIBIT LIST
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`
`
`Case IPR2022-00722
`Patent No. 7,041,786
`
`Pursuant to 37 C.F.R. § 42.63(e), Patent Owner Bausch Health Ireland
`
`Limited hereby submits a current listing of Patent Owner Exhibits.
`
`EXHIBIT
`
`DESCRIPTION
`
`2001
`
`2002
`
`2003
`
`2004
`
`2005
`
`2006
`
`2007
`
`2008
`
`2009
`
`Bausch Health Ireland Ltd. et al. v. MSN Lab 's Private Ltd. et al. ,
`Civil Action No. 2:21-cv-10057 (D.N.J.), ECF No. 51, Amended
`Scheduling Order, Entered January 5, 2022.
`
`Bausch Health Ireland Ltd. et al. v. Mylan Pharms. Inc, Civil Action
`No. l:22-cv-00020 (N.D. W. Va.), ECF No. 98-1, Parties Proposed
`Scheduling Order Checklists, Submitted May 16, 2022.
`
`MSN Defendants' First Set of Requests For Production to Plaintiffs
`(Nos. 1-50), Served on January 11, 2022.
`
`Case Docket of Bausch Health Ireland Ltd. et al. v. MSN Lab 'ys
`Private Ltd. et al. , Civil Action No. 2:21 -cv-10057 (D.N.J.)
`
`Mylan Defendants' First Set of Requests For Production to Plaintiffs
`(Nos. 1-132), Served on May 19, 2022.
`
`MSN's Notice of Paragraph IV Certification Re: MSN's Plecanatide
`Tablets, 3mg, U.S. Patent Nos. 7,041,786; 9,610,321; 9,616,097;
`9,919,024; 9,925,231 ; 10,011 ,637, Dated March 15, 2021 (Excerpt).
`
`Mylan's Notice of Paragraph IV Certification Re: Mylan's
`Plecanatide Tablets, 3mg, U.S. Patent Nos. 7,041 ,786; 9,610,321;
`9,616,097; 9,919,024; 9,925,23 1; 10,011 ,637, Dated March 18, 2021.
`
`Hidaka et al., "In Vitro Disulfide-Coupled Folding of Guanylyl
`Cyclase-Activating Peptide and Its Precursor Protein," Biochemistry,
`Vol. 37, No. 23, 8498-8507 (1998).
`
`Hidaka et al., "Dual Function of the Propeptide of Prouroguanylin in
`the Folding of the Mature Peptide," The Journal of Biological
`Chemistry, Vol. 275, No. 33, 25155-25 162 (2000).
`
`2
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`
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`Case IPR2022-00722
`Patent No. 7,041,786
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`EXHIBIT
`
`DESCRIPTION
`
`2010
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`2011
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`2012
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`2013
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`2014
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`2015
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`2016
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`2017
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`2018
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`2019
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`2020
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`topologies: structure and
`two
`Marx et al., "One peptide,
`interconversion dynamics of human uroguanylin isomers," J. Peptide
`Res. 52, 229-240 (1998).
`
`Chino et al., "Topological
`isomers of human uroguanylin:
`interconversion between biologically active and inactive isomers,"
`FEBS Letters, 421, 27-31 (1 998).
`
`Hamra, "Uroguanylin: Structure and activity of a second endogenous
`peptide that stimulates intestinal guanylate cyclase," Proc. Natl.
`Acad. Sci. USA, Vol. 90, 10464-10468 (1993).
`
`Ironwood Press Release, "Ironwood Pharmaceuticals Promotes Dr.
`Mark Currie to Senior Vice President, Chief Scientific Officer, and
`President of R&D," Dated February 11, 2013.
`
`U.S. Patent No. 7,371,727, titled "Methods and Compositions for the
`Treatment of Gastrointestinal Disorders."
`
`U.S. Patent No. 7,704,947, titled "Methods and Compositions for the
`Treatment of Gastrointestinal Disorders."
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`U.S. Patent No. 7,745,409, titled "Methods and Compositions for the
`Treatment of Gastrointestinal Disorders."
`
`U.S. Patent No. 8,080,526 titled "Methods and Compositions for the
`Treatment of Gastrointestinal Disorders."
`
`U.S. Patent No. 8,110,553, titled "Methods and Compositions for the
`Treatment of Gastrointestinal Disorders."
`
`Brancale et al, "Therapeutically targeting guanylate cyclase-C:
`computational modeling of plecanatide, a uroguanylin analog,"
`Pharma Res Per, Vol. 5, Iss. 2, 1-1 0 (201 7).
`
`Klodt et al., "Synthesis, biological activity and isomerism of
`guanylate cyclase C-activating peptides guanylin and uroguanylin,"
`J. Peptide Res. 50, 222-230 (1997).
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`3
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`Case IPR2022-00722
`Patent No. 7,041 ,786
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`EXHIBIT
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`DESCRIPTION
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`2021
`
`International Publication Number WO 01/25266, titled "Uroguanylin
`as an Intestinal Cancer Inhibiting Agent."
`
`Date: June 29, 2022
`
`Respectfully submitted,
`
`/Justin J. Hasford/
`By :
`Justin J. Hasford, Reg. No. 62,180
`Bryan C. Diner, Reg. No. 32,409
`
`Finnegan, Henderson, Farabow,
`Garrett & Dunner, LLP
`
`Counsel for the Patent Owner
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`4
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`Case IPR2022-00722
`Patent No. 7,041,786
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`CERTIFICATE OF SERVICE
`The undersigned hereby certifies that a copy of the foregoing Patent Owner’s
`
`Exhibit List and Exhibits 2001-2021 were served electronically via email on June
`
`29, 2022 to counsel of record for the Petitioner at the following:
`
`Jad Mills
`Richard Torczon
`Nicole Stafford
`Dennis Gregory
`701 Fifth Avenue, Suite 5100,
`Seattle, WA 98104-7036
`jmills@wsgr.com
`rtorczon@wsgr.com
`nstafford@wsgr.com
`dgregory@wsgr.com
`4863-5899-2145@mail.vault.netdocuments.com
`
`The Petitioner has consented to service by electronic mail.
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`/Geneva Eaddy/
`Geneva Eaddy
`Case Manager
`FINNEGAN, HENDERSON, FARABOW,
` GARRETT & DUNNER LLP
`
`Dated: June 29, 2022
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