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`UNITED STATES PATENT AND TRADEMARK OFFICE
`______________
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`______________
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`TEVA PHARMACEUTICALS USA, INC.,
`Petitioner,
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`v.
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`INDIVIOR UK LIMITED,
`Patent Owner.
`______________
`
`
`
`Case IPR2016-00280
`Patent 8,475,832
`______________
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`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:
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`Exhibit No.
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`1001
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`1002
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`1003
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`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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`Reference
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`U.S. Patent No. 8,475,832 (filed August 7, 2009)
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`File History, U.S. Patent No. 8,475,832
`
`Expert Declaration of Nandita Das, Ph.D., Relating to U.S. Patent
`No. 8,475,832
`
`U.S. Patent Application Publication 2005/0085440 (published April
`21, 2005) (“Birch”)
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`WO 2008/025791 (published March 6, 2008) (“Oksche”)
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`U.S. Patent No. 7,357,891 (published December 23, 2004) (issued
`April 15, 2008) (“Yang”)
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`WO 2008/040534 (published April 10, 2008) (“LabTec”)
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`Suboxone® Label
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`Suboxone® Tablet Summary Basis of Approval (“SBOA”)
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`U.S. Patent Application Publication No. 2005/0037055 (“the ’055
`publication”)
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`European Medicines Agency Initial Marketing-Authorisation
`Document, Scientific Discussion, Oct. 19, 2006 for Suboxone
`sublingual tablets (“EMEA”)
`
`J.P. Cassidy et al., Controlled Buccal Delivery of Buprenorphine, 25
`J. Controlled Release 21 (1993)
`
`Rex M. C. Dawson et al., Data for Biochemical Research (3d ed.
`1986)
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`2
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`1014
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`1015
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`1016
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`1017
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`1018
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`1019
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`1020
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`1021
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`1022
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`1023
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`1024
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`1025
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`1026
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`1027
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`1028
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`Domenic A. Ciraulo et al., Pharmacokinetics and
`Pharmacodynamics of Multiple Sublingual Buprenorphine Tablets
`in Dose-Escelation Trials, 46 J. Clinical Pharmacology 179 (2006)
`
`C. Nora Chiang & Richard L. Hawks, Pharmacokinetics of the
`Combination Tablet of Buprenorphine and Naloxone, 70 Drug &
`Alcohol Dependence S39 (2003)
`
`Campbell et al., The History of the Development of Buprenorphine
`as an Addiction Therapeutic, 1248 Ann. N.Y. Acad. Sc. (Issue:
`Addiction Reviews), 124 (2012) (“Campbell”)
`
`Bullingham et al., Sublingual Buprenorphine Used Postoperatively:
`Clinical Observations and Preliminary Pharmacokinetic Analysis,
`12 Br. J. Clinical Pharmacology 117 (1981)
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`U.S. Patent App. No. US 2010/0087470
`
`U.S. Patent No. 4,582,835
`
`Center for Drug Evaluation and Research, Approval Package for
`App. No. 22-410/S006/S007 (approval date 8/10/12) (“Film
`Approval Package”)
`Encyclopedia of Pharmaceutical Technology, 2nd ed., Vol. I, Drug
`Delivery—Buccal Route (McElnay et al.) (“McElnay”)
`
`U.S. Patent No. 5,288,497 (“Stanley”)
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`Declaration by Maureen Reitman, SC.D. (“Reitman Decl.”)
`
`Parkhurst A. Shore et al., The Gastric Secretion of Drugs: A pH
`Partition Hypothesis, 119 J. Pharmacology Exp. Ther. 361 (1957)
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`Curriculum Vitae of Nandita Das, Ph.D.
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`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)
`Declaration of Eleanor Yost in Support of Petitioner’s Motion to
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`1029
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`1030
`1031
`1032
`1033
`1034
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`Correct Filing Date, IPR2016-00281, IPR2016-00282
`Declaration of Linda Rogers in Support of Petitioner’s Motion to
`Correct Filing Date, IPR2016-00281, IPR2016-00282
`PRPS System Notification - Petition Submission IPR2016-00280
`PRPS System Notification - Petition Submission IPR2016-00281
`PRPS System Notification - Petition Submission IPR2016-00282
`500 7th Ave, New York, NY FedEx Location Website Printout
`Telephone Conference Transcript, Teva Pharmaceuticals USA, Inc.
`v. Indivior UK Ltd., IPR2016-00280 (May 16, 2016)
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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 was served electronically via e-mail on May 25,
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`2016 on the following:
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`Andrea G. Reister
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`areister@cov.com
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`Enrique D. Longton
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`rlongton@cov.com
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`By: /Molly R. Grammel/
` Molly R. Grammel
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`Dated: May 25, 2016
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