Paper No. __
`Filed: November 8, 2014
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`____________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`____________________
`
`BIODELIVERY SCIENCES INTERNATIONAL, INC.
`Petitioner
`
`v.
`
`RB PHARMACEUTICALS LIMITED
`Patent Owner.
`
`____________________
`
`Case IPR2014-00325
`Patent 8,475,832
`____________________
`
`PATENT OWNER’S EXHIBIT LIST
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`Filed: November 8, 2014
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`____________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`____________________
`
`BIODELIVERY SCIENCES INTERNATIONAL, INC.
`Petitioner
`
`v.
`
`RB PHARMACEUTICALS LIMITED
`Patent Owner.
`
`____________________
`
`Case IPR2014-00325
`Patent 8,475,832
`____________________
`
`PATENT OWNER’S EXHIBIT LIST
`
`
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`
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`
`
`Case IPR2014-00325
`Patent No. 8,475,832
`
`Description
`
`Affidavit of Daniel A. Ladow in Support of Motion for Pro Hac Vice
`Admission
`
`U.S. Patent No. 7,598,343
`
`
`
`Exhibit
`No.
`
`2001
`
`2002
`(NEW)
`
`2003
`
`Declaration of Thomas P. Johnston, Ph.D.
`
`2004
`
`Thomas P. Johnston, Ph.D. curriculum vitae
`
`2005
`
`Lewis and Readhead, “Novel analgestics and molecular rearrangements
`in the morphine-thebaine group. XVIII. 3- deoxy-6,14-endo-etheno-
`6,7,8,14-tetrahydrooripavines,” J Med Chem 13:525-7, (1970)
`
`2006
`
`Stoller et al., “Effects of buprenorphine/naloxone in opioid-dependent
`humans,” Psychopharmacology 154:230-242, 230 (2001) (“Stoller”)
`
`2007
`
`SUBOXONE® Tablet Data Sheet, 2006
`
`2008
`
`U.S. Patent No. 4,464,378
`
`2009
`
`2010
`
`Brewster et al., “The systemic bioavailability of buprenorphine by
`various routs of administration,” J. Pharm. Pharmacol. 33:500-506,
`504-5 (1981) (Brewster)
`
`Bullingham et al., “Sublingual buprenorphine used postoperatively: ten
`hour plasma drug concentration analysis,” Br. J. Clin. Pharmac.
`13:665-673, 665 (1982) (Bullingham 1982)
`
`2
`
`
`
`
`2011
`
`2012
`
`2013
`
`2014
`
`2015
`
`2016
`
`2017
`
`2018
`
`2019
`
`Case IPR2014-00325
`Patent No. 8,475,832
`
`Kuhlman et al., “Human pharmacokinetics of intravenous, sublingual,
`and buccal buprenorphine,” Journal of Analytical Toxicology 20:369-
`378, 369 (1996)
`
`Mendelson et al., “Bioavailability of sublingual buprenorphine,” J.
`Clin. Pharmacol. 37:31-37, 31 (1997) (“Mendelson 1997”)
`
`Robinson, “Buprenorphine: An analgesic with an expanding role in the
`treatment of opioid addiction,” CNS Drug Reviews 8:377-390, 381
`(2002)
`
`Chiang and Hawks “Pharmacokinetics of the combination tablet of
`buprenorphine and naloxone,” Drug and Alcohol Dependence 70:S39-
`S47, S40 (2003)
`
`Harris et al, “Pharmacokinetics and subjective effects of sublingual
`buprenorphine alone or in combination with naloxone,” Clin.
`Pharmacokinet. 76:329-340, 330 (2004)
`
`Elkader and Sproule “Buprenorphine Clinical pharmacokinetics in the
`treatment of opioid dependence,” Clin. Pharmacokinet. 44:661-680,
`663 (2005) (Elkader)
`
`Welsh and Valadez-Meltzer “Buprenorphine: a (relatively) new
`treatment for opioid dependence,” Psychiatry (Edgmont) 2:29-39, 32
`(2005) (Welsh)
`
`Rance and Shillingford “The metabolism of phenolic opiates by rat
`intestine,” Xenobiotica 7:529-536, 534 (1977) (Rance)
`
`Iribarne et al., “Involvement of cytochrome P450 3A4 in n-dealkylation
`of buprenorphine in human liver microsomes,” Life Sci. 60:1953-64
`(1997) (Iribarne)
`
`3
`
`
`
`
`2020
`
`2021
`
`2022
`
`2023
`
`2024
`
`2025
`
`2026
`
`2027
`
`Case IPR2014-00325
`Patent No. 8,475,832
`
`Chang et al., “Novel metabolites of buprenorphine detected in human
`liver microsomes and human urine,” Drug Metab. and Disp. 34:440-
`448, 446 (2006) (“Chang”)
`
`Bullingham et al., “Buprenorphine kinetics” Clin. Pharmacol. 28:667-
`672, 670-671 (1980) (“Bullingham 1980”)
`
`McQuay and Moore “Buprenorphine Kinetics in Humans,” In:
`Buprenorphine: Combatting Drug Abuse With A Unique Opioid
`Cowan, Lewis (Eds.) (1995) pp. 137-147, 140-41, Table II
`
`Tam “Individual Variation in First-Pass Metabolism,” Clin.
`Pharmacokinet. 25:300-328, 300 (1993) (Tam)
`
`Rowland and Tozer “Therapeutic relevance,” In: Clinical
`Pharmacokinetics and Pharmacodynamics: Concepts and Applications,
`Rowland, Tozer (Eds.), 4th Edition, Lippincott Williams & Wilkins,
`New York (2011) pp. 3-16 (Rowland)
`
`Shargel et. al., “Relation of Dose to Pharmacologic Effect” In: Applied
`Bi pharmaceuticals & Pharmacokinetics, Shargl, Wu-Pong, Yu (Eds.),
`5th Edition, McGraw Hill, New York (2005) pp.577-580
`
`Rowland and Tozer “Variability,” In: Clinical Pharmacokinetics:
`Concepts and Applications, Rowland, Tozer (Eds.), 3rd Edition,
`Lippincott Williams & Wilkins, New York (1995) pp. 203-219
`(Rowland 1995).
`
`Walter and Inturrisi “Absorption, distribution, metabolism, and
`excretion of buprenorphine in animals and humans,” In:
`Buprenorphine: Combatting Drug Abuse with a Unique Opioid.
`Cowan, Lewis (Eds.) (1995) pp. 113-135, 127
`
`2028
`
`Bullingham et al., “Sublingual buprenorphine used postoperatively:
`
`4
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`
`
`2029
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`2030
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`2031
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`2032
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`2033
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`2034
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`2035
`
`2036
`
`Case IPR2014-00325
`Patent No. 8,475,832
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`clinical observations and preliminary pharmacokinetic analysis,” Br. J.
`Clin. Pharmacology 12:117-122, 121 (1981)
`
`Johnson et al., “Buprenorphine: considerations for pain management,”
`J. Pain and Symptom Management 3:297-326, 302
`
`Summary of Product Characteristics for Subutex 0.4 mg, 2 mg, and 8
`mg Sublingual tablets at
`http://www.medicines.ie/medicine/1658/SPC/Subutex+0.4mg%2c+2m
`g+and+8mg+Sublingual+Tablets/ downloaded on Nov. 2, 2014
`
`Washington and Fanciullo “Buprenorphine: Side-Effects and
`Tolerability,” In: Handbook of Methadone Prescribing and
`Buprenorphine Therapy, Cruciani, Knotkova (Eds.) (2013) pp. 201-
`212, 203
`
`Fishman et al., “Disposition of naloxone-7,8-3H in normal and narcotic-
`dependent men,” J. Pharmacol. Exp. Ther. 187:575-580, 577-579
`(1973) (Fishman)
`
`Chamberlain and Klein, “A comprehensive review of naloxone for the
`emergency physician,” American J. Emergency Medicine 12:650-660,
`650 (1994)
`
`Martin et al., “Bioavailability investigation of a new tilidine/naloxone
`liquid formulation compared to a reference formulation,” Arzneim.-
`Forsch./Drug Res. 49:599-607, 604-606 (Table 4 and Fig. 5)
`
`Smith et al., “Low absolute bioavailability of oral naloxone in healthy
`subjects” Int. J. Clin. Pharm. And Thera. 50:360-367, 362-364 (2012)
`
`Shargel et. al., “Physiological factors related to drug absorption” In:
`Applied Biopharmaceuticals & Pharmacokinetics, Shargel, Wu-Pong,
`Yu (Eds.), 5th Edition, McGraw Hill, New York (2005) pp. 371-409,
`
`5
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`2037
`
`2038
`
`2039
`
`Case IPR2014-00325
`Patent No. 8,475,832
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`373-379
`
`Shojaei, “Buccal mucosa as a route for systemic drug delivery: a
`review,” J. Pharm. Pharmaceut. Sci. 1:15-30, 21-29 (1998)
`
`Suboxone® Sublingual Film 2014 Product Insert, p. 1, col. 1, lines 5-7
`and 29-31 (“Suboxone® 2014 PI”)
`
`Opioid dependence treatment from BDSI aims to challenge RB’s
`Suboxone at http://medcitynews.com/2012/04/opioid-dependence-
`treatment-from-bdsi-aims-to-challenge-rbs-suboxone downloaded Nov.
`2, 2014
`
`2040
`
`NDA Study 20-291-SA, pp. 56-59, 58
`
`2041
`
`Rowland and Tozer “Why Clinical Pharmacokinetics?,” In: Clinical
`Pharmacokinetics: Concepts and Applications, Rowland, Tozer (Eds.),
`3rd Edition, Lippincott Williams & Wilkins, New York (1995) pp. 1-7.
`
`2042
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`IPR2014-00376, Paper 9 (April 18, 2014)
`
`2043
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`IPR2014-00376, Paper 22 (October 27, 2014) at 2
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`2044
`
`2045
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`2046
`
`International Patent Publication No. WO2013096811, published July
`24, 2014, to Finn et al.
`
`2013 United States Securities and Exchange Commission Form 10-K
`for BioDelivery Sciences International, Inc
`
`June 6, 2014 Press Release: BioDelivery Sciences Receives FDA
`Approval for BUNAVAIL™ (buprenorphine and naloxone) Buccal
`Film for the Maintenance Treatment of Opioid Dependence
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`6
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`2047
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`2048
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`2049
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`Case IPR2014-00325
`Patent No. 8,475,832
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`Transcript from the September 6, 2014 Investor and Analyst Day
`Conference Call regarding BioDelivery Sciences' (BDSI) Hosts
`Investor and Analyst Event on BUNAVAIL Launch and Pipeline
`(highlighting added)
`
`Transcript from the September 9, 2014 Morgan Stanley Healthcare
`Conference regarding BioDelivery Sciences International's (BDSI)
`CEO Mark Sirgo Presents at Morgan Stanley Healthcare Conference
`(highlighting added)
`
`June 10, 2013 Press Release: BioDelivery Sciences Announces NDA
`Submission for BUNAVAIL on Track Following Positive Pre-NDA
`Meeting with FDA
`
`2050
`
`Orange Book listing for Suboxone® film
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`7
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`IPR2014-00325
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`CERTIFICATE OF SERVICE
`
`The undersigned hereby certifies that copies of the foregoing Patent Owner
`Response and associated exhibits were served electronically via email on
`November 8, 2014, on attorneys for Petitioner:
`
`Danielle L. Herritt
`Kia L. Freeman
`MCCARTER & ENGLISH, LLP
`265 Franklin Street
`Boston, MA 02110
`
`dherritt@mccarter.com
`IPR832@mccarter.com
`
`
`
`
`
`
`
`
`Dated: November 8, 2014
`
`
`
`
`
` /James M. Bollinger/
`James M. Bollinger
`Reg. No. 32,555
`
`
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`1
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