Filed: February 26, 2016
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`______________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`______________
`
`
`
`TEVA PHARMACEUTICALS USA, INC.,
`Petitioner,
`
`v.
`
`MONOSOL RX, LLC,
`Patent Owner.
`______________
`
`
`
`Case IPR2016-00282
`Patent 8,017,150
`______________
`
`
`PETITIONER’S UPDATED EXHIBIT LIST
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`______________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`______________
`
`
`
`TEVA PHARMACEUTICALS USA, INC.,
`Petitioner,
`
`v.
`
`MONOSOL RX, LLC,
`Patent Owner.
`______________
`
`
`
`Case IPR2016-00282
`Patent 8,017,150
`______________
`
`
`PETITIONER’S UPDATED EXHIBIT LIST
`
`
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`Pursuant to 37 C.F.R. § 42.63(e), Petitioner submits the following current
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`exhibit list:
`
`Exhibit No.
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`1001
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`1002
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`1003
`
`1004
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`1005
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`1006
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`1007
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`1008
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`1009
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`1010
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`1011
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`1012
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`1013
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`1014
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`
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`Description
`
`U.S. Patent No. 8,017,150 (filed Apr. 22, 2008)
`
`File History, U.S. Patent No. 8,017,150
`
`Expert Declaration of Nandita Das, Ph.D. In Support of Petition for
`Inter Partes Review of U.S. Patent No. 8,017,150
`
`U.S. Patent No. 4,713,243 (filed June 16, 1986) (“Schiraldi”)
`
`U.S. Patent No. 6,322,811 (issued November 27, 2001) (“Verma”)
`
`U.S. Patent Application Pub. No. US 2005/0037055 (published
`February 17, 2005) (“Yang”)
`
`[Intentionally Left Blank]
`
`E.W. Flick, Water-Soluble Resins – An Industrial Guide (2nd ed.
`1991) (“Flick”)
`
`Joint Claim Construction Chart, Reckitt Benckiser Pharmaceuticals
`Inc. v. Teva Pharmaceuticals USA, Inc., CA No. 14-1451-RGA
`(November 17, 2015), D.I. 91
`
`U.S. Provisional Application No. 60/328,868
`
`U.S. Provisional Application No. 60/473,902
`
`[Intentionally Left Blank]
`
`Proposed Joint Pre-Trial Order, Reckitt Benckiser Pharmaceuticals,
`Inc. v. Watson Laboratories, Inc., C.A. No. 13-cv-0167-RGA, D.I.
`347
`
`Reckitt Benckiser Pharmaceuticals Inc. et al v. Watson
`Laboratories, Inc et al, CA No. 13-1674-RGA, D.I. 364 (“Proposed
`Findings of Fact”)
`
`
`
`1015
`
`1016
`
`1017
`
`1018
`
`1019
`
`1020
`
`1021
`
`1022
`
`1023
`
`1024
`
`1025
`
`1026
`
`1027
`
`1028
`
`1029
`
`[Intentionally Left Blank]
`
`Trial Transcript, Reckitt Benckiser Inc. v. Watson Labs., Inc., CA
`No. 14-1574-RGA (Nov. 3-4, 2015) (“Trial Tr.”)
`
`U.S. App. No. 10/856,176
`
`R. Anders & H.P. Merkle, Evaluation of Laminated Muco-Adhesive
`Patches for Buccal Drug Delivery, 49 Int’l J. Pharmaceutics 231
`(1989) (“Anders”)
`
`Viralkumar F. Patel et al., Advances in Oral Transmucosal Drug
`Delivery, 153 J. Controlled Release 106 (2011)
`
`U.S. Patent No. 5,948,430 (filed August 1, 1997) (“Zerbe”)
`
`WO 00/42992 (published July 27, 2000) (“Chen I”)
`
`Guo & Zerbe, Water-Soluble Film for Oral Administration, 13th
`International Symposium on Controlled Release of Bioactive
`Materials, 227 (1997) (“Guo”)
`
`EP No. 0,090,560 (published May 3, 1989) (“Mitra”)
`
`U.S. Patent No. 4,849,246 (issued July 18, 1989) (“Schmidt”)
`
`U.S. Patent No. 6,552,024 (filed November 5, 1999) (“Chen II”)
`
`S. Le Person et al., Near Infrared Drying of Pharmaceutical Thin
`Films: Experimental Analysis of Internal Mass Transport, 37
`Chemical Engineering & Processing 257 (1998) (“Le Person”)
`
`Gary DeGrande et al., Specialized Oral Mucosal Drug Delivery
`Systems, in Oral Mucosal Drug Delivery (James Swarbrick, ed.,
`1995)
`
`A. Apicella et al., Poly(ethylene oxide) (PEO) and Different
`Molecular Weight PEO Blends Monolithic Devices for Drug
`Release, 14(2) Biomaterials 83 (1993) (“Apicella”)
`
`Hans P. Merkle et al., Mucoadhesive Buccal Patches for Peptide
`Delivery, in Bioadhesive Drug Delivery Systems (Vincent Lenaerts
`
`
`
`
`
`
`
`& Robert Gurny, eds., 1990)
`
`Remington’s Pharmaceutical Sciences (Alfonso R. Gennaro,
`ed.,17th ed. 1985)
`
`C.S. Fuller et al., Interactions in poly(ethylene oxide)—
`hydroxypropyl methylcellulose blends, 42 Polymer 9583 (2001)
`(“Fuller”)
`
`J.P. Cassidy et al., Controlled buccal delivery of buprenorphine, 25
`Journal of Controlled Release 21 (1993) (“Cassidy”)
`
`Jian-Hwa Guo & K. M. Cooklock, Bioadhesive Polymer Buccal
`Patches for Buprenorphine Controlled Delivery: Solubility
`Consideration, 21(17) Drug Dev. & Indus. Pharmacy 2013 (1995)
`(“Guo & Cooklock”)
`
`Gordon L.Amidon et al., A Theoretical Basis for a
`Biopharmaceutic Drug Classification: The Correlation of in Vitro
`Drug Product Dissolution and in Vivo Bioavailability, 12(3)
`Pharmaceutical Res. 413 (1995) (“Amidon”)
`
`Marilyn N. Martinez & Gordon L. Amidon, A Mechanistic
`Approach to Understanding the Factors Affecting Drug
`Absorption: A Review of Fundamentals, 42 J. Clinical
`Pharmacology 620 (2002) (“Martinez”)
`
`Robert O. Ebewele, Polymer Science and Technology (2000)
`(“Polymer Science and Technology”)
`
`Philip E. Slade, Jr., Polymer Molecular Weights (in two parts), Part
`I (1975)
`
`G.S. Misra, Introductory Polymer Chemistry (1993)
`
`Textbook of Polymer Science (2nd ed. 1971)
`
`WO 2000/02955 (published January 20, 2000) (“Wang”)
`
`U.S. Patent No. 6,562,375 (filed August 1, 2000) (“Sako”)
`
`1030
`
`1031
`
`1032
`
`1033
`
`1034
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`1035
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`1036
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`1037
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`1038
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`1039
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`1040
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`1041
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`Exhibit No.
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`Reference
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`1042
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`1043
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`1044
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`1045
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`1046
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`1047
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`1048
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`1049
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`Michael A. Repka & James W. McGinity, Influence of Vitamin E
`TPGS on the Properties of Hydrophilic Films Produced by Hot-
`Melt Extrusion, 202 Int’l J. Pharmaceutics 63 (2000) (“Repka”)
`
`U.S. Patent No. 4,764,378 (filed February 10, 1986) (“Keith”)
`
`U.S. Patent No. 5,273,758 (filed Apr. 13, 1992) (“Royce”)
`
`U.S. Patent No. 4,284,534 (filed October 24, 1980) (“’534 patent”)
`
`U.S. Patent No. 5,656,296 (filed August 12, 1997) (“Khan”)
`
`Curriculum Vitae of Nandita Das, Ph.D.
`
`List of Materials Considered by Nandita Das, Ph.D.
`
`Telephone Conference Transcript, Teva Pharmaceuticals USA, Inc.
`v. Monsol RX LLC and Indivior, IPR2016-00280, IPR2016-00281,
`and IPR2016-00282 (Feb. 17, 2016)
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`Pursuant to the Board’s directive during the parties’ February 17, 2016 call
`
`with the Board, Petitioner herewith files Exhibit 1049, Telephone Conference
`
`Transcript, Teva Pharmaceuticals USA, Inc. v. Monsol RX LLC and Indivior,
`
`IPR2016-00280, IPR2016-00281, and IPR2016-00282 (Feb. 17, 2016).
`
`Dated: February 26, 2016
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`
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`Respectfully submitted,
`
`/Elizabeth J. Holland/
`Elizabeth J. Holland (Reg. No. 47,657)
`Goodwin Procter LLP
`The New York Times Building
`620 Eighth Avenue
`New York, NY 10018
`Tel: 212-813-8800
`Counsel for Petitioner
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`CERTIFICATE OF SERVICE
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`The undersigned hereby certifies that the foregoing: PETITIONER’S
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`UPDATED EXHIBIT LIST and accompanying Exhibit 1049 were served
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`electronically via e-mail on February 26, 2016 on the following:
`
`Daniel A. Scola, Jr.
`
`dscola@hbiplaw.com
`
`Michael I. Chakansky
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`mchakansky@hbiplaw.com
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`150ipr@hbiplaw.com
`
`By: /Cynthia Lambert Hardman/
` Cynthia Lambert Hardman
`(Reg. No. 53,179)
`
`
`
`6
`
`Dated: February 26, 2016
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