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`Paper No._______
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`UNITED STATES PATENT AND TRADEMARK OFFICE
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`_______________
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`_______________
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`BIODELIVERY SCIENCES INTERNATIONAL, INC.
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`Petitioner
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`v.
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`RB PHARMACEUTICALS LIMITED
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`Patent Owner
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`_______________
`
`
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`Case No. IPR2014-00325
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`Patent 8,475,832
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`_______________
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`PETITIONER’S FIRST UPDATED EXHIBIT LIST
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`ACCOMPANYING REPLY
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`ME1 19747844v.1
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`Case IPR2014-00325
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`Exhibit
`No.
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`Description
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`1001
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`US Patent 8,475,832
`
`1002
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`Reckitt Benckiser Pharmaceuticals, Inc., RB Pharmaceuticals
`Limited, and MonoSol, RX, LLC., WDNC Civil Action No. 5:13-cv-
`760, Complaint filed October 29, 2013 (“Complaint”)
`
`1003
`
`2012 Reckitt Annual Report (“Annual Report”)
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`1004
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`Declaration of Maureen Reitman, Sc.D. (“Reitman”)
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`1005
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`1006
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`Declaration of Phillip T. Lavin, Ph.D. (“Lavin”)
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`First Office Action mailed August 31, 2011 (“First OA”)
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`1007
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`Response filed February 29, 2012 (“First Response”)
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`1008
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`1009
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`1010
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`Second Office Action mailed May 2, 2012 (“Second OA”)
`
`Response to filed October 22, 2012 (“Second Response”)
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`Third Office Action mailed November 6, 2012 (“Third OA”)
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`1011
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`Response to filed April 30, 2013 (“Third Response”)
`
`1012
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`1013
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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
`
`Notice of Allowance mailed May 24, 2013, including the attached
`Interview Summary (“NOA”)
`
`Suboxone® tablet label, Revised September 2006 (“Suboxone Tablet
`Label”)
`
`Merriam-Webster’s Collegiate Dictionary (10th ed. 2000)
`
`European Medicines Agency (EMEA) Study Report on Suboxone®
`tablets, 2006 (“Suboxone Tablet Study Report”)
`
`US Patent No. 7,357,891, published December 23, 2004, to Yang et
`al. (“Yang”)
`
`International Patent Publication No. WO 2008/040534, published
`April 10, 2008, to Applicant Labtec GmbH (“Labtec”)
`
`International Patent Publication No. WO 2008/025791, published
`March 6, 2008, to Applicant Euro-Celtique S.A. (“Euro-Celtique”)
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`ME1 19747844v.1
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`1
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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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`Case IPR2014-00325
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`US Patent Publication No. 2005/0085440, published April 21, 2005,
`to Birch et al. (“Birch”)
`
`Power of Attorney
`
`Assignment from Reckitt Benckiser Healthcare (UK) Limited to RB
`Pharmaceuticals Limited
`
`Assignment from MonoSol Rx, LLC to Reckitt Benckiser Healthcare
`(UK) Limited
`
`US Patent No. 7,425,292, published September 16, 2008, to Yang et
`al.
`
`1024
`
`M.Voet, THE GENERIC CHALLENGE (Brown Walker Press 2d ed. 2008)
`
`1025
`
`1026
`
`1027
`
`P.J. Tiseo, et al., Br J Clin Pharmacol. Nov 1998; 46 (Suppl 1): 51–
`55, An evaluation of the pharmacokinetics of Donepezeil HCL and
`patients with impaired hepatic function (marked as exhibit during
`deposition, but not filed)
`
`Zyprexa Prescribing Information, Copyright © 1997, 2003, Eli Lilly
`and Company (marked as exhibit during deposition, but not filed)
`
`IPR2014-00325, Institution Decision, Paper No. 17 (marked as
`exhibit during deposition, but not filed)
`
`1028
`
`Full Transcript Deposition of Dr. Johnston dated January 23, 2015
`
`1029
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`1030
`
`1031
`
`1032
`
`1033
`
`1034
`
`1035
`
`1036
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`Declaration of David W. Feigal, MD, MPH
`
`David W. Feigal, MD, MPH CV
`
`Declaration of Christine Siegwarth Meyer, Ph.D.
`
`Christine Siegwarth Meyer, Ph.D. CV & Materials Considered
`
`IPR2014-000998, Paper No. 2, Petition
`
`IPR2014-00998, Paper No. 12, Institution Decision
`
`IPR2014-00998, Paper No. 6, Motion for Joinder
`
`US 2014/0005218, Publication of USSN 13/964,975, published
`January 2, 2014
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`ME1 19747844v.1
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`2
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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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`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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`Case IPR2014-00325
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`Non-final Rejection of USSN 13/964,975, mailed November 7, 2013
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`Amendment and Response of USSN 13/964,975, filed January 2,
`2014
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`Final Rejection of USSN 13/964,975, mailed March 7, 2014
`
`RB Press Release, “US FDA Marketing Approval For Reckitt
`Benckiser’s Subutex® & Suboxone®,” October 9, 2002 available at:
`https://www.rb.com/documentdownload.axd?documentresourceid=8
`
`FDA Website, “Developing Products for Rare Diseases &
`Conditions” available at:
`http://www.fda.gov/forindustry/DevelopingProduCTsforrareDiseases
`Conditions/default.htm
`
`FDA Website, “Frequently Asked Questions on Patents and
`Exclusivity” available at:
`http://www.fda.gov/Drugs/DevelopmentApprovalProcess/ucm079031
`.htm
`
`FDA National Drug Code Database Search Results, available at:
`http://www.accessdata.fda.gov/scripts/cder/ndc/default.cfm (Type:
`Active Ingredient; Name: buprenorphine)
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`2013 Reckitt Benckiser Group Annual Report
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`Federal Register 2013-13446 (FDA re Suboxone Withdrawal)
`
`RB Press Release, “Proposed Demerger of the RB Pharmaceuticals
`business,” November 17, 2014 available at:
`https://www.rb.com/proposed-demerger-of-the-rb-pharmaceuticals-
`business
`
`Paul Ragusa and Dennis Bissonnette, Product Improvements and Life
`Cycle Management – Antitrust Pitfalls, New Jersey Intellectual
`Property Law Association, available at:
`http://www.njipla.org/Resources/Documents/event_proceedings/2012
`-12-05-26th-Annual-Pharmaceutical-
`Chemical/NJIPLA%20Presentation%20on%20Product%20Switching-
`--Final%20Paper%20NY02%20760911%201-2.pdf
`
`1048
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`Jessie Cheng, An Antitrust Analysis of Product Hopping in the
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`ME1 19747844v.1
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`3
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`Case IPR2014-00325
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`Pharmaceutical Industry, COLUM. L. REV., Issue 6, October 2008
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`Sean Royall, Ashely E. Johnson, and Jason C. McKenney, Antitrust
`Scrutiny of Pharmaceutical “Product Hopping,” ANTITRUST, Vol.
`28, No. 1, Fall 2013
`
`2010 Reckitt Benckiser Group Annual Report
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`2011 Reckitt Benckiser Group Annual Report
`
`Lachman Consultant Services, Inc. Citizen Petition, September 27,
`2012 (Docket No. FDA–2012–P–1034)
`
`RB Press Release, Further US RB Pharmaceuticals Announcement,
`September 25, 2012 available at:
`http://www.rb.com/site/rkbr/templates/mediainvestorsgeneral2.aspx?p
`ageid=1332&cc=GB
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`1049
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`1050
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`1051
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`1052
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`1053
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`ME1 19747844v.1
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`4
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`Case IPR2014-00325
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`CERTIFICATE OF SERVICE
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`The undersigned hereby certifies that a copy of the foregoing PETITIONER’S
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`FIRST UPDATED EXHIBIT LIST ACCOMPANYING REPLY, including this
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`Certificate of Service, was electronically served on January 30, 2015 by
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`transmitting a copy to lead counsel James Bollinger at
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`james.bollinger@troutmansanders.com and to backup counsel Daniel Ladow at
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`daniel.ladow@troutmansanders.com in accordance with the consent set forth in RB
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`Third Amended Mandatory Notice Information.
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`ME1 19747844v.1
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`By:
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`/Danielle L. Herritt/
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`Danielle L. Herritt
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`Registration No. 43,670
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`Attorney for the Petitioner
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`5
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