UNITED STATES PATENT AND TRADEMARK OFFICE
`_____________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________________
`
`MYLAN PHARMACEUTICALS INC.,
`
`
`Petitioner,
`
`v.
`
`COSMO TECHNOLOGIES LIMITED,
`Patent Owner.
`
`U.S. Patent No. 9,320,716 to Villa et al.
`Case No..: IPR2017-01035
`
`U.S. Patent No. 8,784,888 to Villa et al.
`Case No.: IPR2017-01034
`_____________________
`
`
`Petitioner’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
`
`
`
`
`_____________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________________
`
`MYLAN PHARMACEUTICALS INC.,
`
`
`Petitioner,
`
`v.
`
`COSMO TECHNOLOGIES LIMITED,
`Patent Owner.
`
`U.S. Patent No. 9,320,716 to Villa et al.
`Case No..: IPR2017-01035
`
`U.S. Patent No. 8,784,888 to Villa et al.
`Case No.: IPR2017-01034
`_____________________
`
`
`Petitioner’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
`
`
`
`
`
`
`
`Petitioner
`Exhibit #
`1001
`
`Petitioner’s Exhibit List
`
`Description
`
`U.S. Patent No. 9,320,716 to Villa et al., “Controlled Release and
`Taste Masking Oral Pharmaceutical Compositions”
`U.S. Patent No. 8,784,888 to Villa et al., “Controlled Release and
`Taste Masking Oral Pharmaceutical Composition”
`Reserved
`Reserved
`Reserved
`Declaration of Anthony Palmieri III, Ph.D., R.Ph.
`Curricula Vitae of Anthony Palmieri, Ph.D., R.Ph.
`U.S. Patent No. 5,681,584 to Savastano et al., “Controlled Release
`Drug Delivery Device”
`U.S. Patent No. 5,811,388 to Friend et al., “Delivery of Drugs to the
`Lower GI Tract”
`U.S. Patent No. 6,239,120 to Hallgren et al., “Method and Means for
`Treating Glomerulonephritis”
`U.S. Patent Appl. Pub. No. 2006/0134208 to Villa et al., “Controlled
`Release and Taste Masking Oral Pharmaceutical Composition”
`1012 Markman Opinion and Order in Cosmo Technologies Limited v.
`Alvogen Pine Brook, LLC., C.A. No. 15-193-LPS, ECF Nos. 167, 168
`(D. Del. Sept. 7, 2016).
`Amendment and Response to Advisory Action filed on February 21,
`2014 in U.S. Patent Appl. No. 13/617,138
`Substitute Specification (Clean Copy) filed on April 29, 2013 in U.S.
`Patent Appl. No. 13/617,138
`Amendment After Final filed on April 29, 2013 in U.S. Patent Appl.
`No. 13/617,138
`Amendment and Response to Office Action filed on July 1, 2013 in
`U.S. Patent Appl. No. 13/617,138
`U.S. Patent No. 6,607,751 to Odidi et al., “Controlled Release
`Delivery Device for Pharmaceutical Agents Incorporating Microbial
`Polysaccharide Gum”
`Campieri et al., Oral Budesonide is as Effective as Oral Prednisolone
`in Active Crohn’s Disease, Gut, 41:209-214 (1997)
`Reserved
`Reserved
`
`1002
`
`1003
`1004
`1005
`1006
`1007
`1008
`
`1009
`
`1010
`
`1011
`
`1013
`
`1014
`
`1015
`
`1016
`
`1017
`
`1018
`
`1019
`1020
`
`
`
`
`
`
`
`1021
`1022
`
`1023
`
`1024
`
`1025
`1026
`
`1027
`1028
`1029
`1030
`
`1031
`1032
`1033
`
`1034
`
`1035
`
`1036
`
`1037
`
`1038
`
`1039
`
`1040
`
`Reserved
`PCT International Publication No. WO 96/36318, “Three-Phase
`Pharmaceutical Form With Constant and Controlled Release of
`Amorphous Active Ingredient for Single Daily Application”
`U.S. Patent No. 5,342,625 to Hauer et al., “Pharmaceutical
`Compositions Comprising Cyclosporins”
`PCT International Publication No. WO 99/39700, “Pharmaceutical
`compositions in form of nanoparticles comprising lipidic substances
`and amphiphilic substances and related preparation process”
`FDA Inactive Ingredient Guide 1996/1997
`Handbook of Pharmaceutical Excipients (Wade and Weller, eds., 2d
`ed. 1994)
`Reserved
`Remington: The Science and Practice of Pharmacy, Vol. 1 (1995)
`Reserved
`Hawley’s Condensed Chemical Dictionary (John Wiley & Sons, Inc.,
`13th ed. 1997)
`Reserved
`Entocort® EC Highlights of Prescribing Information
`Svensson et al., Hydration of an Amphiphilic Excipient, Gelucire
`44/14, 2004, <hal-00015990>
`U.S. Patent No. 6,395,300 to Straub et al., “Porous Drug Matrices
`and Methods of Manufacture Thereof”
`Flanders et al., The Control of Drug Release From Conventional
`Melt Granulation Matrices, Drug Development & Industrial
`Pharmacy, 13(6):1001-1022 (1987)
`Gandhi et al., Extrusion and Spheronization in the Development of
`Oral Controlled-Release Dosage Forms, Pharmaceutical Sci. &
`Tech. Today 2(4):160 (1999)
`US Patent No. 4,880,830 to Alan Rhodes, “Slow Release
`Formulation”
`Daly et al., The Effect of Anionic Surfactants on the Release of
`Chlorpheniramine from a Polymer Matrix Tablet, Int’l J. of
`Pharmaceutics, 18:201-05 (1984)
`S.S. Davis, The Design and Evaluation of Controlled Release
`Dosage Forms for Oral Delivery, S.T.P. Pharma 3(5):412-417
`(1987)
`U.S. Patent No. 5,849,327 to Berliner et al., “Delivery of Drugs to
`the Lower Gastrointestinal Tract”
`
`
`
`
`
`
`
`1041
`
`1042
`1043
`
`1044
`
`1045
`
`U.S. Patent No. 5,643,602 to , “Oral Composition for the Treatment
`of Inflammatory Bowel Disease”
`U.S. Provisional Application No. 60/080,274 filed on April 1, 1998
`Gliko-Kabir et al., Low Swelling, Crosslinked Guar and Its Potential
`Use as a Colon-Specific Drug Carrier, Pharm. Research 15(7):1019-
`1025 (1998)
`See A Blume, B Arnold, HU Weltzien, Effects of a synthetic
`lysolecithin analog on the phase transition of mixtures of
`phosphatidylethanolamine and phosphatidylcholine, FEBS Letters
`(1976)
`Qiu et al., Design of sustained-release matrix systems for a highly
`water-soluble compound, ABT-089, Int’l J. of Pharmaceutics 157:43-
`52 (1997)
`1046 M. Efentakis et al., The Influence of Surfactants on Drug Release
`from a Hydrophobic Matrix, Int’l J. Pharm. 70:153-58 (1991)
`Uceris® website, https://www.uceris.com/tablet/ (accessed on March
`5, 2017)
`Santarus’ CEO Discusses FDA Approval Of UCERIS (Budesonide)
`For
`The Induction Of Remission In Patients With Active, Mild To
`Moderate
`Ulcerative Colitis (Transcript) (Jan. 15, 2013)
`Uceris® Instant Savings Program
`Transcript of the Second Quarter 2014 Earnings Conference Call of
`Salix Pharmaceuticals, Ltd.
`L.W. Doner, Determining Sugar Composition of Food Gum
`Polysaccharides by HPTLC, Chromatographia 2001, 53, May (No.
`9/10)
`Amendment filed on January 15, 2013 in U.S. Patent Appl. No.
`13/617,138
`Specification of U.S. Patent Application No. 10/009,532
`Specification of 12/210,969 application
`Specification of 13/249,839 application
`Specification of 13/462,409 application
`Final Office Action of March 6, 2013 in U.S. Patent Appl. No.
`13/617,138
`Applicant-Initiated Interview Summary of April 23, 2013 in U.S.
`Patent Appl. No. 13/617,138
`
`1053
`1054
`1055
`1056
`1057
`
`1047
`
`1048
`
`1049
`1050
`
`1051
`
`1052
`
`1058
`
`
`
`
`
`
`
`1059
`
`1060
`1061
`
`1062
`
`
`
`Original Specification as field on September 14, 2012 in U.S. Patent
`Appl. No. 13/617,138
`Orange Book Listing of Uceris® (accessed on March 8, 2017)
`Hawley’s Condensed Chemical Dictionary (John Wiley & Sons, Inc.,
`13th ed. 1997)
`N. Robinson, Surface Interaction of Lecithin and Lysolecithin, J. of
`Pharmacy and Pharmacology, 12(1) 609-616 (1960)
`
`
`
`
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