`Filed Nov. 27, 2017
`
`Filed on behalf of Argentum Pharmaceuticals LLC
`
`By:
`
`Kevin B. Laurence
`Laurence & Phillips IP Law LLP
`1940 Duke Street, Suite 200
`Alexandria, Virginia 22314
`Tel: 703.448.8787
`Fax: 703.439.1624
`klaurence@lpiplaw.com
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________________________________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________________________________________
`
`ARGENTUM PHARMACEUTICALS LLC,
`Petitioner
`
`v.
`
`
` COSMO TECHNOLOGIES LIMITED,
`Patent Owner
`
`
`
`
`
`
`
`Inter Partes Review No. IPR2018-00080
`U.S. Patent No. 9,320,716 B2
`
`PETITIONER’S EXHIBIT LIST
`
`
`
`
`
`Pursuant to 37 C.F.R. § 42.63(e), Petitioner submits this Exhibit List.
`
`Description
`
`Filed
`Exhibit
`1001 U.S. Patent No. 9,320,716 to Villa et al., “Controlled Release and Taste
`Masking Oral Pharmaceutical Compositions”
`1002 U.S. Patent No. 8,784,888 to Villa et al., “Controlled Release and Taste
`Masking Oral Pharmaceutical Composition”
`Reserved
`1003
`1004 Reserved
`1005 Reserved
`1006 Declaration of Hartmut Derendorf, Ph.D.
`1007 Curricula Vitae of Hartmut Derendorf, Ph.D.
`1008 U.S. Patent No. 5,681,584 to Savastano et al., “Controlled Release
`Drug Delivery Device”
`1009 U.S. Patent No. 5,811,388 to Friend et al., “Delivery of Drugs to the
`Lower GI Tract”
`1010 U.S. Patent No. 6,239,120 to Hallgren et al., “Method and Means for
`Treating Glomerulonephritis”
`1011 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).
`1013 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
`
`1014
`
`1015
`
`
`
`
`
`
`
`
`
` 2
`
`
`
`Description
`
`Filed
`Exhibit
`1016 Amendment and Response to Office Action filed on July 1, 2013 in
`U.S. Patent Appl. No. 13/617,138
`1017 U.S. Patent No. 6,607,751 to Odidi et al., “Controlled Release Delivery
`Device for Pharmaceutical Agents Incorporating Microbial
`Polysaccharide Gum”
`1018 Campieri et al., Oral Budesonide is as Effective as Oral Prednisolone
`in Active Crohn’s Disease, Gut, 41:209-214 (1997)
`1019 Reserved
`1020 Reserved
`1021 Reserved
`1022
`PCT International Publication No. WO 96/36318, “Three-Phase
`Pharmaceutical Form With Constant and Controlled Release of
`Amorphous Active Ingredient for Single Daily Application”
`1023 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
`1025
`1026 Handbook of Pharmaceutical Excipients (Wade and Weller, eds., 2d
`ed. 1994)
`1027 Reserved
`1028 Remington: The Science and Practice of Pharmacy, Vol. 1 (1995)
`1029 Reserved
`1030 Hawley’s Condensed Chemical Dictionary (John Wiley & Sons, Inc.,
`13th ed. 1997)
`1031 Reserved
`
`1024
`
`1032 Entocort® EC Highlights of Prescribing Information
`
`
`
`
`
`
`
` 3
`
`
`
`Description
`
`Filed
`Exhibit
`1033
`
`1035
`
`Svensson et al., Hydration of an Amphiphilic Excipient, Gelucire
`44/14, 2004, <hal-00015990>
`1034 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)
`1036 Gandhi et al., Extrusion and Spheronization in the Development of
`Oral Controlled-Release Dosage Forms, Pharmaceutical Sci. & Tech.
`Today 2(4):160 (1999)
`1037 US Patent Formulation”
`1038 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)
`International Publication No. WO 2005/075002 to Taguchi et al.
`1040
`1041 English Translation of International Publication No. WO 2005/075002
`to Taguchi et al. and corresponding Translation Certification
`International Publication No. WO 2005/007835 to Wang
`1042
`1043 Ohno-Matsui, In vitro and in vivo characterization of iris pigment
`epithelial cells cultured on amniotic membranes, Molecular Vision,
`Vol. 12, pp. 1022-1032 (August 2006)
`1044 Hanada et al., Multilayered Amniotic Membrane Transplantation for
`Severe Ulceration of the Cornea and Sclera, American J. of
`Ophthalmol., Vol. 131, No. 3, pp. 324-331 (March 2001)
`1045 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)
`
`1039
`
`
`
`
`
` 4
`
`
`
`
`
`
`
`Description
`
`Filed
`Exhibit
`1047 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)
`1049 Uceris® Instant Savings Program
`1050 Transcript of the Second Quarter 2014 Earnings Conference Call of
`Salix Pharmaceuticals, Ltd.
`1051 L.W. Doner, Determining Sugar Composition of Food Gum
`Polysaccharides by HPTLC, Chromatographia 2001, 53, May (No.
`9/10)
`1052 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
`
`1048
`
`1053
`
`1054
`1055
`1056
`
`Specification of 12/210,969 application
`Specification of 13/249,839 application
`Specification of 13/462,409 application
`
`1057
`
`Final Office Action of March 6, 2013 in U.S. Patent Appl. No.
`13/617,138
`1058 Applicant-Initiated Interview Summary of April 23, 2013 in U.S.
`Patent Appl. No. 13/617,138
`1059 Original Specification as filed on September 14, 2012 in U.S. Patent
`Appl. No. 13/617,138
`1060 Orange Book Listing of Uceris® (accessed on March 8, 2017)
`1061 Hawley’s Condensed Chemical Dictionary (John Wiley & Sons, Inc.,
`13th ed. 1997)
`1062 N. Robinson, Surface Interaction of Lecithin and Lysolecithin, J. of
`Pharmacy and Pharmacology, 12(1) 609-616 (1960)
`
`
`
` 5
`
`
`
`1063 E-mail regarding retention of Dr. Palmieri
`1064 E-mail regarding deposition of Dr. Derendorf
`
`
`Dated: November 27, 2017
`
`
`
`Respectfully Submitted,
`
`
`
`
`
`
`
`By:
`
`/Kevin B. Laurence/
`Kevin B. Laurence
`Registration No. 38,219
`
`Back-up Counsel for Petitioner,
`Argentum Pharmaceuticals LLC
`
`
`
`
`
` 6
`
`
`
`CERTIFICATE OF SERVICE
`
`I hereby certify that on Nov. 27, 2017, a copy of the foregoing EXHIBIT
`
`LIST and Exhibits 1063–1064 were served via email upon the following
`
`counsel of record for the patent owner, as consented to by said counsel:
`
`Gary N. Frischling: gfrischling@irell.com
`Yite John Lu: yjlu@irell.com
`IRELL & MANELLA LLP
`1800 Avenue of the Stars, Suite 900
`Los Angeles, California 90067
`
`Dated: November 27, 2017
`
`Respectfully submitted,
`
`/Kevin B. Laurence/
`Kevin B. Laurence, Registration No. 38,219
`Back-up Counsel for Petitioner
`
`LAURENCE & PHILLIPS IP LAW LLP
`
`