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
`Patent No. 9,919,024
`————————————————
`
`PETITIONER MYLAN PHARMACEUTICALS INC.
`UPDATED EXHIBIT LIST
`
`
`
`————————————————
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`————————————————
`
`MYLAN PHARMACEUTICALS INC.,
`Petitioner,
`
`v.
`BAUSCH HEALTH IRELAND LIMITED,
`Patent Owner.
`
`————————————————
`Case IPR2022-01104
`Patent No. 9,919,024
`————————————————
`
`PETITIONER MYLAN PHARMACEUTICALS INC.
`UPDATED EXHIBIT LIST
`
`
`
`LIST OF EXHIBITS
`
`Exhibit No.
`
`Description
`
`1001
`
`1002
`
`1003
`
`1004
`
`1005
`
`1006
`
`1007
`
`1008
`
`1009
`
`1010
`
`Comiskey, Formulations of Guanylate Cyclase C Agonists and
`Methods of Use, U.S. Patent No. 9,919,024, issued March 20, 2018
`
`Expert Declaration of Graham Buckton, Ph.D.
`
`Curriculum vitae of Graham Buckton, Ph.D.
`
`Expert Declaration of Uwe Christians, M.D.
`
`K. Shailubhai et al., Guanylate Cyclase Receptor Agonists for the
`Treatment of Tissue Inflammation and Carcinogenesis, U.S. Patent
`No. 7,041,786 (2006)
`
`E. Rudnic, Chapter 45: Oral Solid Dosage Forms, REMINGTON:
`THE SCIENCE AND PRACTICE OF PHARMACY, 21st ed., 2005
`
`A. Mihranyan et al., Moisture Sorption by Cellulose Powders of
`Varying Crystallinity, INT. J. PHARM., 269(2), 433-442 (2004)
`
`HANDBOOK OF PHARMACEUTICAL EXCIPIENTS, 6th ed., 2009
`
`K. Shailubhai et al., SP-304 to Treat GI Disorders – Effects of a
`Single, Oral-Dose of SP-304 on Safety, Tolerability,
`Pharmacokinetics and Pharmacodynamics in Healthy Volunteers,
`GASTROENTEROL., 136(5), A641, Abstract W1041 (2009)
`
`E. Doelker et al., Morphological, Packing, Flow and Tableting
`Properties of New Avicel Types, DRUG DEV. IND. PHARM., 21(6),
`643-661 (1995)
`
`-1-
`
`
`
`Exhibit No.
`
`Description
`
`1011
`
`1012
`
`1013
`
`1014
`
`1015
`
`1016
`
`1017
`
`1018
`
`1019
`
`D. Zimmer et al., Methods and Compositions for the Treatment of
`Heart Failure and Other Disorders, WO 2008/106429 (2008)
`
`A. Fretzen et al., Stable Solid Formulation of a GC-C Receptor
`Agonist Polypeptide Suitable for Oral Administration, WO
`2010/019266, published February 18, 2010
`
`K. Shailubhai et al., Phase II Clinical Evaluation of SP-304, a
`Guanylate Cyclase-C Agonist, for Treatment of Chronic
`Constipation, Abstract 1322, AM. J. GASTROENTEROL.,
`105(Supplement 1), S487-S488 (2010)
`
`R. Hegazi et al., Sp304, An Analog of Uroguanylin, Ameliorates
`Inflammation in a Model of Experimental Colitis, Abstract M1696,
`AGA Abstracts, A-351 (2006)
`
`CDER, Guidance for Industry: Estimating the Maximum Safe
`Starting Dose in Initial Clinical Trials for Therapeutics in Adult
`Healthy Volunteers (2005)
`
`Lai, et al., Solid-State Chemical Stability of Proteins and Peptides,
`PHARM. SCI., 88(5), 489-500 (1999), for example, teaches the
`stability of peptide drugs was known to be sensitive to temperature,
`moisture, and excipients.
`Callisto Pharmaceuticals, SP-304 Science,
`https://web.archive.org/web/20081106172937/https://www.callisto
`pharma.com/content/pipeline/guanilib/science.jsp, captured by the
`WayBack Machine on November 6, 2008.
`J. Ebel et al., Compositions, Methods, and Kits for Enhancing
`Immune Response to a Respiratory Condition, U.S. Patent
`Publication No. 2009/0196921, (August 6, 2009)
`R. Porubcan, Formulations Including Digestive Enzymes and
`Polysorbate Surfactants that Enhance the Colonization of
`Administered Probiotics Microorganisms, U.S. Patent Publication
`No. 2008/0187525 (2008)
`
`
`
`Exhibit No.
`
`Description
`
`1020
`
`1021
`
`1022
`
`1023
`
`1024
`
`1025
`
`1026
`
`1027
`
`1028
`
`1029
`
`1030
`
`1031
`
`PROTEIN FORMULATION AND DELIVERY, 2nd ed., 2008
`
`File History of U.S. Patent Application No. 14/845,644 (issuing as
`9,610,321)
`
`File History of U.S. Patent Application No. 13/421,769 (issuing as
`9,616,097)
`
`Intentionally left blank.
`
`File History of U.S. Patent Application No. 15/467,648 (issuing as
`9,919,024)
`
`U.S. Provisional Patent Application No. 61/383,156, filed
`September 15, 2010.
`
`U.S. Provisional Patent Application No. 61/387,636, filed
`September 29, 2010.
`
`U.S. Provisional Patent Application No. 61/392,186, filed October
`12, 2010.
`
`L. Peyrin-Biroulet et al., Crohn’s disease: beyond antagonists of
`tumour necrosis factor, LANCET, 372, 67-81 (2008)
`
`M. Aulton, Pharmaceutics: The Science of Dosage Form Design,
`2nd ed. (2001)
`
`I. Parikh et al., Methods for Attenuating Release of Inflammatory
`Mediators and Peptides Useful Therein, WO 2008/014414 (2008)
`
`M. Camilleri et al., Challenges to the Therapeutic Pipeline for
`Irritable Bowel Syndrome: End Points and Regulatory Hurdles,
`GASTROENTEROL., 135, 1877-1891 (2008)
`
`
`
`Exhibit No.
`
`Description
`
`1032
`
`1033
`
`1034
`
`1035
`
`1036
`
`1037
`
`1038
`
`1039
`
`M. Currie et al., Methods and Compositions for the Treatment of
`Gastrointestinal Disorders, U.S. Patent Publication No.
`2005/0020811 (2005)
`
`Curriculum vitae of Uwe Christians, M.D.
`
`Intentionally left blank.
`
`Bausch Health Ireland Ltd. v. Mylan Laboratories Ltd., 2-21-cv-
`00573 (WDPA), Stay Order
`
`FDA, Guidance for Industry, Q1A(R2) Stability Testing of New
`Drug Substances and Products, 2003
`
`Intentionally left blank
`
`Document No. 51: Amended Scheduling Order, Bausch Health
`Ireland Ltd. v. MSN Laboratories Private Ltd., 2:21-cv-10057
`(DNJ) (filed Jan. 5, 2022)
`
`Email from Patent Trial and Appeal Board dated November 9,
`2022, authorizing pre-institution Reply Brief and Sur-Reply Brief.
`
`Dated: February 3, 2023
`
`
`
`/Richard Torczon/
`Richard Torczon
`Reg. No. 34,448
` For Mylan Pharmaceuticals Inc.
`
`
`
`CERTIFICATE OF SERVICE
`
`I certify that this paper and EX1039 were filed and served today, February 3,
`
`2023, on the Patent Owner at the electronic service addresses of the Patent Owner
`
`as follows:
`
`
`
`Justin J. Hasford
`Bryan C. Diner
`Joshua L. Goldberg
`Kassandra M. Officer
`Lauren J. Robinson
`Caitlin E. O’Connell
`Kyu Yun Kim
`
`justin.hasford@finnegan.com
`bryan.diner@finnegan.com
`joshua.goldberg@finnegan.com
`kassandra.officer@finnegan.com
`lauren.robinson@finnegan.com
`caitlin.o’connell@finnegan.com
`kyuyun.kim@finnegan.com
`
`Dated: February 3, 2023
`
` /Robyn Moriarty /
`Robyn Moriarty
`
`
`
`
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