`Filed: October 7, 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 IPR2022-01104
`U.S. Patent No. 9,919,024
`__________________
`
`PATENT OWNER’S EXHIBIT LIST
`
`
`
`
`Pursuant to 37 C.F.R. § 42.63(e), Patent Owner hereby submits a current
`
`Case No. IPR2022-01104
`U.S. Patent No. 9,919,024
`
`listing of Patent Owner Exhibits.
`
`EXHIBIT
`
`DESCRIPTION
`
`
`
`2001
`
`2002
`
`2003
`
`2004
`
`2005
`
`2006
`
`2008
`
`2009
`
`titled
`International Publication Number WO 02/078683 Al1_
`Guanylate Cyclase Receptor Agonists for the Treatment of Tissue
`Inflammation and Carcinogenesis.
`
`International Publication Number WO 2005/016244 A2 titled
`Methods and Compositions for the Treatment of Gastrointestinal
`Disorders.
`
`Kunwar Shailubhai et al., “A Randomized, Double-blind, Placebo-
`Controlled, Single-, Ascending-, Oral-Dose Safety, Tolerability and
`Pharmacokinetic Study of SP-304 in Healthy Adult Human Male and
`Female Volunteers,” Digestive Disease Week, San Diego: 2008.
`
`Christians Lab, Department of Anesthesiology, School of Medicine,
`University
`of
`Colorado,
`available
`at
`https://medschool.cuanschutz.edu/anesthesiology/research-
`innovation/basic-research-pis/christians-lab.
`
`Faculty Profile for Uwe Christians, MD, PhD., Department of
`Anesthesiology, School of Medicine, University of Colorado,
`https://som.ucdenver.edu/Profiles/Faculty/Profile/4832.
`
`available at
`Bibliography for Uwe Christians, MD, PhD.,
`https://www.ncbi.nlm.nih.gov/myncbi/12extkpeOjlgmf/bibliograph
`y/public.
`
`2007
`
`Reserved.
`
`Prescribing Information for Linzess (Revised 8/2021), available at
`https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/202811
`s018Ibl.pdf.
`
`Marco van de Weert and Theodore W. Randolph, “Chapter 6 -
`Physical Instability of Peptides and Proteins,” of PHARMACEUTICAL
`FORMULATION DEVELOPMENT OF PEPTIDES AND PROTEINS
`
`(Lars
`
`
`
`Case No. IPR2022-01104
`U.S. Patent No. 9,919,024
`
`
`
`EXHIBIT
`
`DESCRIPTION
`
`Hovgaard, Sven Frokjaer and Marco van de Weert eds., Taylor &
`Francis Group 2013).
`
`Paul A. Bummer, “Chapter 2 - Chemical Considerations in Protein
`and Peptide Stability,” of PROTEIN FORMULATION AND DELIVERY
`SECOND EDITION (Eugene J. McNally and Jayne E. Hastedt eds.,
`Informa Healthcare USA,Inc. 2008).
`
`Theodore W. Randolph and John F. Carpenter, “Engineering
`Challenges of Protein Formulations,” AIChE Journal, 53(8):1902-
`1907 (August 2007).
`
`NDA 208745, Medical Reviews, Center for Drug Evaluation and
`Research,
`available
`at
`https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208745
`Orig] s000MedR.pdf (Excerpted).
`
`NDA208745, Synergy Pharmaceuticals, Inc., Final Clinical Study
`Report, A Randomized, Double-Blind, Placebo-Controlled, Single-,
`Ascending-, Oral-Dose Safety, Tolerability, and Pharmacokinetic
`Study of SP-304 in Healthy Adult Human Male and Female
`Volunteers (Excerpted)
`(Filed UnderSeal).
`
`in
`“Callisto Pharmaceuticals Files IND for SP-304 (Guanilib)
`Chronic Constipation and Irritable Bowel Syndrome,” Business
`Wire, April 07, 2008.
`
`2010
`
`2011
`
`2012
`
`2013
`
`2014
`
`
`
`Dated: October 7, 2022
`
`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
`Caitlin E. O’Connell, Reg. No. 73,934
`Back-up Counsel
`
`
`
`
`
`Case No. IPR2022-01104
`U.S. Patent No. 9,919,024
`
`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
`
`
`3
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`
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`Case No. IPR2022-01104
`U.S. Patent No. 9,919,024
`
`CERTIFICATE OF SERVICE
`
`The undersigned hereby certifies that a copy of the foregoing Patent Owner’s
`
`Exhibit List and Exhibits 2001-2006, 2008-2014 were served electronically via
`
`email on October 7, 2022 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
`4863-5899-2145@mail.vault.netdocuments.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
`
`The Petitioner has consented to service by electronic mail.
`
`
`By: /Geneva Eaddy/
`Geneva Eaddy
`Case Manager
`FINNEGAN, HENDERSON, FARABOW,
`GARRETT & DUNNER, LLP
`
`Date: October 7, 2022
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