UNITED STATES PATENT AND TRADEMARK OFFICE
`___________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`___________________
`
`
`
`MYLAN PHARMACEUTICALS INC.,
`PETITIONER
`
`v.
`
`COSMO TECHNOLOGIES LIMITED,
`PATENT OWNER
`
`___________________
`
`CASE IPR2017-01035
`Patent 9,320,716
`___________________
`
`
`
`
`
`PATENT OWNER'S EXHIBIT LIST
`
`
`
`
`Mail Stop: PATENT BOARD
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`
`
`
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`
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`
`
`
`
`___________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`___________________
`
`
`
`MYLAN PHARMACEUTICALS INC.,
`PETITIONER
`
`v.
`
`COSMO TECHNOLOGIES LIMITED,
`PATENT OWNER
`
`___________________
`
`CASE IPR2017-01035
`Patent 9,320,716
`___________________
`
`
`
`
`
`PATENT OWNER'S EXHIBIT LIST
`
`
`
`
`Mail Stop: PATENT BOARD
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`
`
`
`
`
`
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`
`
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`
`
`IPR2017-01035 (Patent No. 9,320,716)
`Patent Owner Exhibit List
`
`TABLE OF EXHIBITS
`
`
`Patent Owners
`Exhibit No. Description
`M. Brunner et al., "Gastrointestinal transit, release and plasma
`pharmacokinetics of a new oral budesonide formulation", British
`Journal of Clinical Pharmacology, 2005; 61:1, 31-38.
`I. Wilding, "Bioequivalence Testing for Locally Acting
`Gastrointestinal Products: What Role for Gamma Scintigraphy?",
`JClin Pharmacol 2002; 42:1200-1210.
`Redacted letter re joint status report filed June 7, 2017 in Cosmo
`Technologies Limited, et al. v. Mylan Pharmaceuticals Inc., et al,
`CA No. 16-152-LPS (D. Delaware).
`R. Hamedani et al., "Review article: Drug development in
`inflammatory bowel disease: budesonide - a model of targeted
`therapy", Aliment Pharmacol Ther 1997: 11 (Suppl. 3): 98-108.
`I. Koutroubakis. "Recent advances in the management of distal
`ulcerative colitis", World J Gastrointest Pharmacol Ther 2010
`April 6; 1(2): 43-50.
`W. Sandborn, "Step-Up Versus Top-Down Therapy in the
`Treatment of Ulcerative Colitis" Gastroenterology & Hepatology
`Volume 3, Issue 1, January 2007.
`W. Sandborn et al., "Once-Daily Budesonide MMX® Extended-
`Release Tablets Induce Remission in Patients With Mild to
`Moderate Ulcerative Colitis: Results From the CORE I Study",
`Gastroenterology 2012;143:1218–1226.
`C. J. Kenyon et al., "Colonic delivery of dexamethasone: a
`pharmacoscintigraphic evaluation", Aliment Pharmacol Ther
`1997; 11: 205-213.
`R. Lofberg, "New data on inflammatory bowel disease treatment
`with topical steroids", Research and Clinical Forums, Volume 20,
`Number 1, 1998.
`R. Lofberg, "Reviewing Steroids in the Treatment of IBD",
`Research and Clinical Forums, Volume 15, Number 5, 1993.
`
`2001
`
`2002
`
`2003
`
`2004
`
`2005
`
`2006
`
`2007
`
`2008
`
`2009
`
`2010
`
`
`
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`- 1 -
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`IPR2017-01035 (Patent No. 9,320,716)
`Patent Owner Exhibit List
`
`2012
`
`2013
`
`2014
`
`2015
`
`2016
`
`2017
`
`Patent Owners
`Exhibit No. Description
`Amendment and Response submitted July 1, 2013 in prosecution
`2011
`of U.S. App. No. 13/617,138.
`Amendment and Response submitted February 21, 2014 in
`prosecution of U.S. App. No. 13/617,138.
`Amendment and Remarks submitted February 17, 2016 in
`prosecution of U.S. App. No. 14/308,279.
`Merriam-Webster's Collegiate Dictionary, Tenth Edition, 1993.
`McGraw-Hill Dictionary of Scientific and Technical Terms, Fifth
`Edition, 1994.
`U.S. Pat. No. 8,293,273; issued Oct. 23, 2012
`A. J. Greenstein et al., "Differences in pathogenesis, incidence
`and outcome of perforation in inflammatory bowel disease",
`Surgery – Gynecology & Obstetrics, January 1985, Volume 160,
`Number 1.
`M.E. Aulton, "Pharmaceutics – The science of dosage form
`design", 1988.
`J. N. Staniforth., "Ordered Mixing or Spontaneous Granulation?",
`Powder Technology, 45 (1985) 73-77 .
`H. C. Ansel et al., "Pharmaceutical Dosage Forms and Drug
`Delivery Systems", Seventh Edition, 1999.
`M. J. Crooks et al., "Ordered Mixing in Direct Compression of
`Tablets", Powder Technology, 14 (1976) 161 – 167.
`J. A. Hersey, "Ordered Mixing: A New Concept in Powder
`Mixing Practice", Powder Technology. 11 (1975) 41-44.
`W. Shi et al., "Macro- and micro-mixing of a cohesive
`pharmaceutical powder during scale up", Powder Technology 274
`(2015) 319–323.
`U.S. Pat. No. 3,974,249; issued Aug. 10, 1976.
`Transcript of court proceedings held May 23, 2017 in Cosmo
`Technologies Limited, et al. v. Actavis Laboratories, et al., CA
`No. 15-164-LPS (D. Delaware).
`
`2018
`
`2019
`
`2020
`
`2021
`
`2022
`
`2023
`
`2024
`
`2025
`
`
`
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`- 2 -
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`IPR2017-01035 (Patent No. 9,320,716)
`Patent Owner Exhibit List
`
`2026
`
`2027
`
`2028
`
`2029
`
`2030
`
`Patent Owners
`Exhibit No. Description
`R. Lofberg, "Oral Budesonide Versus Prednisolone in Patients
`With Active Extensive and Left-Sided Ulcerative Colitis",
`Gastroenterology 1996; 110:1713–1718.
`J. Corren, "Intranasal corticosteroids for allergic rhinitis: How do
`different agents compare?" J Allergy Clin Immunol 1999;
`104:S144-9.
`D. R. Friend, "Review article: issues in oral administration of
`locally acting glucocorticosteroids for treatment of inflammatory
`bowel disease", J Allergy Clin Immunol 1999; 104:S144-9.
`"Handbook of Pharmaceutical Excipients", 1987.
`A. Nicholls, "Bioavailability profile of Uceris® MMX® extended
`release tablets compared with Entocort® EC capsules in healthy
`volunteers", Journal of International Medical Research 0(0),
`2013, 1-9.
`H. N. E. Stevens, "Pulsincap™ and Hydrophilic Sandwich
`Capsules: Innovative Time-Delayed Oral Drug Delivery
`Technologies", Modified-Release Drug Delivery Technology,
`Second Edition, Volume 1, 2013.
`J. M. Hebden, "Regional Differences in Quinine Absorption from
`the Undisturbed Human Colon Assessed Using a Timed Release
`Delivery System", Pharmaceutical Research, Vol. 16, No. 7,
`1999.
`International Patent Application Publication WO 92/16206,
`published October 1, 1992.
`National Library of Medicine – PubMed Health entry for “Colon
`(Bowel)”, last accessed June 22, 2017 from
`https://www.ncbi.nlm.nih.gov/pubmedhealth/PMHT0022229/
`“Textbook of Gastroenterology” (Yamada, Ed.) 1991
`Redacted email chain re protective order between counsel for
`Patent Owner to Petitioner
`
`2031
`
`2032
`
`2033
`
`2034
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`2035
`
`2036
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`- 3 -
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`IPR2017-01035 (Patent No. 9,320,716)
`Patent Owner Exhibit List
`
`Respectfully submitted,
`
`/s/Gary N. Frischling
`
`
`
`
`
`
`
`Gary N. Frischling, Reg. No. 35,515
`Yite John Lu, Reg. No. 63,158
`Irell & Manella LLP
`
`Attorneys for Patent Owner
`Cosmo Technologies Limited
`
`
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`- 4 -
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`
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`Dated: July 20, 2017
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`IPR2017-01035 (Patent No. 9,320,716)
`Patent Owner Exhibit List
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`
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`CERTIFICATE OF SERVICE
`
`Pursuant to 37 C.F.R. § 42.6, the undersigned certifies that on July 20, 2017,
`
`a copy of the foregoing document PATENT OWNER'S EXHIBIT LIST has
`
`been served in its entirety via e-mail on counsel of record for petitioners at the
`
`following address:
`
`Jitendra Malik, Ph.D. , Reg. No. 55,823
`ALSTON & BIRD LLP
`4721 Emperor Boulevard, Suite 400
`Durham, North Carolina 27703-8580
`919.862.2200
`jitty.malik@alston.com
`
`H. James Abe, Reg. No. 61,182
`ALSTON & BIRD LLP
`333 South Hope Street, 16th Floor
`Los Angeles, CA 90071
`213.576.1000
`james.abe@alston.com
`
`Lance Soderstrom, Reg. No. 65,405
`ALSTON & BIRD LLP
`90 Park Avenue, 15th Floor
`New York, New York 10016-1387
`212.210.9400
`lance.soderstrom@alston.com
`
`Joseph M. Janusz, Reg. No. 70,396
`101 S. Tryon Street, Suite 4000
`Charlotte, NC 28280
`704-444-1000
`joe.janusz@alston.com
`
`
`
`
`
`By: /s/ Susan Langworthy
`Susan Langworthy
`- 5 -
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`
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