`
`Exhibit No.
`1001
`
`1002
`
`1004
`
`1005
`
`1006
`
`1007
`
`1008
`
`1009
`
`1010
`
`1011
`
`1012
`
`1013
`
`1014
`
`
`
`Reference
`U.S. Patent No. 8,475,832 (filed August 7, 2009) (“’832 patent”)
`
`File History, 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)
`
`Domenic A. Ciraulo et al., Pharmacokinetics and
`Pharmacodynamics of Multiple Sublingual Buprenorphine Tablets
`in Dose-Escelation Trials, 46 J. Clinical Pharmacology 179 (2006)
`
`
`
`
`DRL - EXHIBIT 1026
`DRL001
`
`
`
`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. Pub. 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 Marlene Bobka (“Bobka Decl.”)
`
`Parkhurst A. Shore et al., The Gastric Secretion of Drugs: A pH
`Partition Hypothesis, 119 J. Pharmacology Exp. Ther. 361 (1957)
`
`The Theory and Practice of Industrial Pharmacy (L. Lachman,
`Ph.D.) (1986)
`
`Declaration of Nadita Das, Ph.D., filed in the matter Teva
`Pharmaceuticals USA, Inc. v. RB Pharmaceuticals LTD., IPR Case
`No. 2016-00280 (PTAB)
`
`
`-2-
`
`1015
`
`1016
`
`1017
`
`1018
`
`1019
`
`1020
`
`1021
`
`1022
`
`1023
`
`1024
`
`1027
`
`N/A
`
`
`
`DRL - EXHIBIT 1026
`DRL002
`
`
`
`N/A
`
`Declaration of Maureen Reitman, SC.D. Under 37 CFR § 1.132 in
`the matter Biodelivery Sciences International, Inc. v. RB
`Pharmaceuticals Limited, IPR Case No. 2016-00280 (PTAB)
`
`-3-
`
`
`
`
`
`DRL - EXHIBIT 1026
`DRL003