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`UNITED STATES PATENT AND TRADEMARK OFFICE
`______________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`______________
`
`
`
`TEVA PHARMACEUTICALS USA, INC.,
`Petitioner,
`
`v.
`
`INDIVIOR UK LIMITED,
`Patent Owner.
`______________
`
`
`
`Case IPR2016-00280
`Patent 8,475,832
`______________
`
`
`PETITIONER’S UPDATED EXHIBIT LIST
`
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`Pursuant to 37 C.F.R. § 42.63(e), Petitioner submits the following current
`
`exhibit list:
`
`Exhibit No.
`
`1001
`
`1002
`
`1003
`
`1004
`
`1005
`
`1006
`
`1007
`
`1008
`
`1009
`
`1010
`
`1011
`
`1012
`
`1013
`
`Reference
`
`U.S. Patent No. 8,475,832 (filed August 7, 2009)
`
`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”)
`
`WO 2008/025791 (published March 6, 2008) (“Oksche”)
`
`U.S. Patent No. 7,357,891 (published December 23, 2004) (issued
`April 15, 2008) (“Yang”)
`
`WO 2008/040534 (published April 10, 2008) (“LabTec”)
`
`Suboxone® Label
`
`Suboxone® Tablet Summary Basis of Approval (“SBOA”)
`
`U.S. Patent Application Publication No. 2005/0037055 (“the ’055
`publication”)
`
`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)
`
`
`
`
`2
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`
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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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`
`
`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)
`
`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”)
`
`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)
`
`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)
`
`3
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`
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`Pursuant to the Board’s directive during the parties’ February 17, 2016 call
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`with the Board, Petitioner herewith files Exhibit 1027, 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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`Dated: February 26, 2016
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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
`Fax: 212-355-3333
`
`Counsel for Petitioner
`
`4
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`
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`CERTIFICATE OF SERVICE
`
`The undersigned hereby certifies that the foregoing: PETITIONER’S
`
`UPDATED EXHIBIT LIST and accompanying Exhibit 1027 were served
`
`electronically via e-mail on February 26, 2016 on the following:
`
`Andrea G. Reister
`
`areister@cov.com
`
`Enrique D. Longton
`
`rlongton@cov.com
`
`By: /Cynthia Lambert Hardman/
` Cynthia Lambert Hardman
`(Reg. No. 53,179)
`
`5
`
`Dated: February 26, 2016
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