UNITED STATES PATENT AND TRADEMARK OFFICE
`_____________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________________
`
`
`
`COALITION FOR AFFORDABLE DRUGS II LLC
`Petitioner
`
`v.
`
`
`
`NPS PHARMACEUTICALS, INC.
`Patent Owner
`
`_____________________
`
`Case No. IPR2015-01093
`Patent No. 7,056,886
`_____________________
`
`PETITIONER’S UPDATED EXHIBIT LIST
`
`
`
`
`
`
`
`
`_____________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________________
`
`
`
`COALITION FOR AFFORDABLE DRUGS II LLC
`Petitioner
`
`v.
`
`
`
`NPS PHARMACEUTICALS, INC.
`Patent Owner
`
`_____________________
`
`Case No. IPR2015-01093
`Patent No. 7,056,886
`_____________________
`
`PETITIONER’S UPDATED EXHIBIT LIST
`
`
`
`
`
`
`
`
`
`EXHIBIT
`1001
`
`DESCRIPTION
`Declaration of Dr. Anthony Palmieri III, Ph.D., R.Ph.
`
`FILED
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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
`
`1014
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`1015
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`1016
`
`1017
`
`1018
`
`1019
`
`1020
`
`CV of Dr. Palmieri
`
`U.S. Patent No. 7,056,886 to Isaacs
`
`U.S. Patent Application Ser. No. 09/750,022
`
`U.S. Patent No.5,496,801 to Holthuis et al.
`
`U.S. Patent No.6,120,761 to Yamazaki et al.
`
`March 8, 2002 Non Final Office Action
`
`June 10, 2002 Amendment and Reply
`
`February 5, 2003 Non Final Office Action
`
`July 9, 2003 Amendment and Reply
`
`September 16, 2003 Non Final Office Action
`
`March 16, 2004 Amendment and Reply
`
`June 8, 2004 Final Office Action
`
`September 7, 2004 Amendment and Reply
`
`October 4, 2004 Non Final Office Action
`
`January 4, 2005 Amendment and Reply
`
`April 4, 2005 Notice of Allowance and Fee(s) Due
`
`Kieffer & Habener, The Glucagon-Like Peptides,
`Endocrine Reviews 20(6): 876-913 (1999)
`
`Lomize et al., Thermodynamic Model of Secondary
`Structure for α-Helical Peptides and Proteins, Bioploymers
`42:239 (1997)
`
`Dacambra et al., Structural Determinants for Activity of
`Glucagon-like Peptide-2. Biochemistry 39:8888-8894 (July
`
`
`
`2
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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
`
`1029
`
`1030
`
`1031
`
`1032
`
`1033
`
`1034
`
`2000)
`
`Drucker et al., Regulation of the biological activity of
`glucagon-like peptide 2 in vivo by dipeptidyl peptidase IV,
`Nat. Biotechnol. 15(7):673-7. (July 1997)
`
`Munroe et al.,Prototypic G-protein coupled receptor for the
`intestinotrophic factor glucagon –like peptide 2, Proc. Nat’l
`Acad. Sci. 96:1569 (1999)
`
`Drucker et al., Human [Gly2]GLP-2 reduces the severity of
`colonic injury in a murine model of experimental colitis,
`Am J. Physiology 276:G79 (1999)
`
`Cleland et al., Formulation and Delivery of Proteins and
`Peptides, American Chemical Society,Washington D.C.,
`Chapter 1 (1994)
`
`WO 99/043361 to Knudsen
`
`U.S. Patent No. 4,985,244 to Makino
`
`U.S. Patent No. 5,652,216 to Kornfelt et al.
`
`PCT Publication WO98/52600
`
`U.S. Patent No. 5,789,379 to Drucker et al.
`
`Osterberg et al., Physical state of L-histidine after freeze-
`drying and long-term storage, EP. J. of Pharm. Sci. 1999
`Aug., 8:301-308.
`
`Intentionally Left Blank
`
`Shire Development IPR Petition
`
`Shire Federal Circuit Brief
`
`Declaration of Brent Routman in Support of Petitioner’s
`Motion for Admission Pro Hac Vice
`
`1035
`
`NPS Pharmaceuticals, Inc., Annual Report (Form 10-K)
`
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`---
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`3
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`1036
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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
`1042
`1043
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`1044
`1045
`1046
`1047
`1048
`1049
`1050
`1051
`1052
`1053
`
`1054
`
`1055
`
`(February 18, 2015)
`
`Declaration of Professor Marc I. Steinberg, J.D., LL.M.
`
`Joint letter from AARP, AHIP, BCBSA and PCMA to
`Chairmen Grassley and Goodlatte and Ranking Members
`Leahy and Conyers (July 9, 2015)
`
`Dean Baker, The Impact of Exempting the Pharmaceutical
`Industry from Patent Reviews, Center for Economic and
`Policy Research (July, 2015)
`
`Orange Book: Approved Drug Products with Therapeutic
`Equivalence Evaluations, Gattex
`
`Matthew Herper, Inside the Pricing of a $300,000-A-Year
`Drug, Forbes (January 3, 2013)
`Reply Declaration of Anthony Palmieri III, Ph.D., R.Ph.
`Reply Declaration of Ivan Hofmann (Confidential)
`Deposition Transcript of Dr. John Carpenter, dated March
`30, 2016
`Dr. John Carpenter Deposition Exhibit No. 102
`Dr. John Carpenter Deposition Exhibit No. 104
`Dr. John Carpenter Deposition Exhibit No. 105
`Dr. John Carpenter Deposition Exhibit No. 108
`Dr. John Carpenter Deposition Exhibit No. 109
`Dr. John Carpenter Deposition Exhibit No. 110
`Dr. John Carpenter Deposition Exhibit No. 111
`Manning et al., 1989 Pharm. Res. 6, 903-918
`Linde et al., Journal of Chromatography, 530:29-37 (1990)
`Yahoo Finance, NBI Pharmaceuticals historical monthly
`stock prices, 2012-2015
`(http://finance.yahoo.com/q/hp?s=%5ENBI&a=09&b=1&c
`=2012&d=01&e=2&f=2015&g=m)
`Shire to Acquire NPS Pharmaceuticals for $5.2B – Nasdaq
`Analyst Blog
`(http://www.nasdaq.com/article/shire-to-acquire-nps-
`pharmaceuticals-for-52b-analyst-blog-cm432089)
`Shire to Acquire NPS Pharma as Further Step in Building a
`Leading Biotech – Shire
`
`
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`4
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`
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`1056
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`1057
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`1058
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`1059
`1060
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`1061
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`1062
`1063
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`1064
`
`1065
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`1066
`
`1067
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`1068
`
`1069
`
`Newsroom(https://www.shire.com/newsroom/2015/january
`/shire-to-acquire-nps-pharma-as-further-step-in-building-a-
`leading-biotech)
`Shire, 2015, “Shire to acquire NPS Pharmaceuticals”
`Presentation (January 11, 2015)
`Shire, Half Yearly Report 2015
`(http://investors.shire.com/~/media/Files/S/Shire-
`IR/annual-interim-reports/year-2015/half-yearly-report-
`july-2015-v1.pdf)
`Shire, 2015, “Shire to acquire NPS Pharmaceuticals” Call
`Transcript (January 11, 2015)
`Shire, 2015 Form 10-K
`Gattex, “About Gattex.” (https://www.gattex.com/about-
`gattex.aspx)
`Gattex, “Why Choose Gattex?”
`(https://www.gattex.com/getting-started/why-choose-
`gattex.aspx)
`Shire 2014 Annual Report
`Shire, 2016, “Creating the global leader in Rare Diseases;
`Fourth quarter and full year results to December 31, 2015”
`(February 11, 2016)
`NPS, 2012, “FDA Approves Gattex® (teduglutide [rDNA
`Origin]) for Injection for the Treatment of Adult Short
`Bowel Syndrome” (December 21, 2012)
`(http://ir.npsp.com/releasedetail.cfm?releaseid=830142)
`OnePath, https://www.shire.com/patients/patient-
`services/onepath
`Gattex, “Patient Support.”
`(https://www.gattex.com/patient-support.aspx)
`FDA: Search Orphan Drug Designations and Approvals
`(https://www.accessdata.fda.gov/scripts/opdlisting/oopd/O
`OPD_Results_2.cfm)
`Fox Business “Why One Drug Costs $295K a Year”
`January 24, 2013.
`(http://www.foxbusiness.com/features/2013/01/24/why-
`one-drug-costs-25k-year.html)
`FDA: Frequently Asked Questions (FAQ) Regarding
`Designating an Orphan Product
`(http://www.fda.gov/ForIndustry/DevelopingProductsforRa
`
`
`
`5
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`1070
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`1071
`1072
`1073
`1074
`1075
`1076
`1077
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`1078
`1079
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`1080
`
`1081
`
`1082
`
`1083
`
`reDiseasesConditions/HowtoapplyforOrphanProductDesig
`nation/ucm240819.htm)
`FDA: Small Business Assistance: Frequently Asked
`Questions for New Drug Product Exclusivity
`(http://www.fda.gov/Drugs/DevelopmentApprovalProcess/
`SmallBusinessAssistance/ucm069962.htm)
`Curriculum vitae of Ivan T. Hofmann, CPA/CFF, CLP
`U.S. Patent No. 7,847,061 B2
`FDA Approved Drug Products Zorbtive
`Patient Assistance Program
`NPS List of Subsidiaries
`Gattex Orange Book
`Deposition Transcript of Gordon Rausser, Ph.D. dated
`March 23, 2016 (Confidential)
`U.S. Patent No. 9,060,992
`FDA: Orphan Products: Hope for People With Rare
`Diseases
`(http://www.fda.gov/drugs/resourcesforyou/consumers/ucm
`143563.htm)
`Navarro, R.P., Malone, D.C., Manieri, E., Frear, R.S.,
`Regan, T.S., Urick, P.N, and T.J. White, 2009, “Pharmacy
`& Therapeutics Committees in managed care
`organizations,” in Robert P. Navarro, ed., Managed Care
`Pharmacy Practice, Sudbury, Mass.: Jones and Bartlett
`Publishers
`Silverman, Ed. “Tiger in the Fiscal Room: Beware the
`Increasing Cost And Number of Orphan Drugs.” Managed
`Care, March 2013.
`(http://www.managedcaremag.com/archives/2013/3/tiger-
`fiscal-room-beware-increasing-cost-and-number-orphan-
`drugs)
`Boggs, Jennifer. “Gattex Gains Approval in SBS; NPS
`Plans 1Q Launch.” BioWorld, December 21, 2012
`(http://www.bioworld.com/content/gattex-gains-approval-
`sbs-nps-plans-1q-launch-0)
`Yahoo Finance, NPS Pharmaceuticals historical monthly
`stock prices, 2012-2015
`(http://finance.yahoo.com/q/hp?s=NPSP&a=09&b=1&c=2
`012&d=03&e=1&f=2015&g=m)
`
`
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`6
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`
`
`
`
`1084
`
`1085
`
`1086
`1087
`1088
`1089
`1090
`
`1091
`
`Yahoo Finance, XBI Pharmaceuticals historical monthly
`stock prices, 2012-2015
`(http://finance.yahoo.com/q/hp?s=XBI&a=09&b=1&c=201
`2&d=03&e=1&f=2015&g=m)
`FDA Approves Gattex to treat short bowel syndrome,
`December 21, 2012.
`(http://www.fiercebiotech.com/biotech/fda-approves-
`gattex-to-treat-short-bowel-syndrome )
`Dr. Gordon Rausser Deposition Exhibit No. 8
`Dr. Gordon Rausser Deposition Exhibit No. 9
`Dr. Gordon Rausser Deposition Exhibit No. 10
`U.S. Patent No. 5,656,730
`Dr. John Carpenter Deposition Exhibit No. 103
`
`Petitioner’s Demonstrative Exhibit for Oral Hearing
`
`
`
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`7
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`
`
`Certification of Service
`
`Pursuant to 37 C.F.R § 42.6, the undersigned hereby certifies that a copy of
`
`this PETITIONER’S UPDATED EXHIBIT LIST was served on June 21, 2016
`
`by email on counsel of record for the Patent Owner as follows:
`
`
`Joseph R. Robinson
`Heather Morehouse Ettinger
`Troutman Sanders LLP
`The Chrysler Building
`405 Lexington Avenue
`New York, NY 10174-0700
`joseph.robinson@troutmansanders.com
`heather.ettinger@troutmansanders.com
`
`Dustin B. Weeks
`Troutman Sanders LLP
`Bank of America Plaza
`600 Peachtree Street NE, Suite 5200
`Atlanta, GA 30308-2231
`dustin.weeks@troutmansanders.com
`
`
`
`Date: June 21, 2016
`
`
`
`
`
`Respectfully submitted,
`
`
`
`
`/Matthew L. Fedowitz/
`Matthew L. Fedowitz, Reg. No. 61,386
`MERCHANT & GOULD P.C.
`Attorney for Petitioner CFAD
`
`8
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