`
`From:
`Sent:
`To:
`
`Subject:
`Attachments:
`
`PRPS SYSTEM NOTIFICATION [PRPS_Trial@uspto.gov]
`Thursday, January 21, 2016 2:25 AM
`jblake@merchantgould.com; mfedowitz@merchantgould.com; Ettinger, Heather; Robinson,
`Joseph R.; Weeks, Dustin B.; Ettinger, Heather
`Party filing notice received - IPR2015-00990
`webwbUSPTOSeal2.gif
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`PATENT TRIAL AND APPEAL BOARD
`
`Filing Courtesy Notice
`
`Please note the following filing:
`
`Case Number:
`Filer:
`Filing Date:
`
`IPR2015-00990
`NPS Pharmaceuticals, Inc. of Bedminster, NJ
`1/21/2016
`
`Type
`
`Exhibit
`
`Document List
`Paper Name
`Transcript of Video
`Deposition of
`Anthony Palmieri
`III, Ph.D.
`CV of John F.
`Carpenter, Ph.D.
`CV of Gordon
`Exhibit
`Rausser, Ph.D.
`Exhibit
`Jackson 2012
`Exhibit
`Onoue 2004
`U.S. Pharmacopeia Exhibit
`
`Exhibit
`
`Paper / Exhibit Number
`
`2042
`
`2043
`
`2044
`2045
`2046
`2047
`
`1
`
`
`
`Exhibit
`Exhibit
`Exhibit
`Exhibit
`Exhibit
`Exhibit
`Exhibit
`
`Exhibit
`
`Exhibit
`
`Exhibit
`
`Exhibit
`
`24, 774-77 (1999)
`Joshi 2012
`Fang 2012
`Blundell 1983
`Boesch 1978
`Akers 2002
`U.S. Pharmacopeia
`788 (2011)
`Remington 1990
`U.S. Patent
`Publication No.
`2013/0310314
`Annex1 Summary
`of Product
`Characteristics
`Orange Book
`Listing for Gattex Exhibit
`Eli Lilly and Co.
`Exhibit
`(2012)
`Al-Hussein 2013
`Exhibit
`Izutsu 2009
`Exhibit
`U.S. Pharmacopeia
`23, 1650-51 (1995) Exhibit
`Center for Drug
`Evaluation and
`Research,
`Application Number
`203441Orig1s000,
`Chemistry
`Review(s)
`U.S. Food and Drug
`Administration,
`FDA Approved
`Drug Products -
`Zorbtive.
`Shire, Shire
`completes
`acquisition of NPS
`Pharma, February
`21, 2015
`Engellenner 2015
`Walker, Joseph and
`Rob Copeland, New
`Hedge Fund
`Strategy Dispute the
`Patent, Short the
`Stock, Wall Street
`Journal April 7,
`2015
`
`Exhibit
`
`Exhibit
`
`Exhibit
`
`2048
`2049
`2050
`2051
`2052
`2053
`2054
`
`2055
`
`2057
`
`2058
`
`2059
`2060
`2061
`2062
`
`2063
`
`2064
`
`2065
`
`2066
`
`2067
`
`2
`
`
`
`Wieczner 2015
`Buchman 2006
`Pirona 2015
`O'Keefe 2006
`Buchman 1997
`NPS 2012 -
`Developing orphan
`products for patients
`Hofstetter 2013
`O'Keefe 2015 -
`Nutritional Issues in
`the SBS
`Tee 2011 -
`Emerging
`Treatment Options
`for SBS - Potential
`Role of Teduglutide
`Naberhuis 2015 -
`Teduglutide for
`Safe Reduction of
`Parenteral Nutrient
`Buchman 2012 -
`Teduglutide and
`SBS
`FDA - Approved
`Drug Products
`Zorbtive
`Crohn's and Colitis
`2013 - Short Bowel
`Syndrome and
`Crohn's Disease
`Donohoe 2010 -
`Short Bowel
`Syndrome
`Zorbtive label
`Wales 2010 -
`Human growth
`hormone and
`glutamine
`Serono 2005 -
`Annual Report
`Part 1 Merck 2013 -
`Annual Report
`Part 2 Merck 2013 -
`Annual Report
`Keller 2004 -
`Management of the
`Short Bowel
`Syndrome after
`
`Exhibit
`Exhibit
`Exhibit
`Exhibit
`Exhibit
`
`Exhibit
`
`Exhibit
`
`Exhibit
`
`Exhibit
`
`Exhibit
`
`Exhibit
`
`Exhibit
`
`Exhibit
`
`Exhibit
`
`Exhibit
`
`Exhibit
`
`Exhibit
`
`Exhibit
`
`Exhibit
`
`Exhibit
`
`2068
`2069
`2070
`2071
`2072
`
`2073
`
`2074
`
`2076
`
`2077
`
`2078
`
`2079
`
`2080
`
`2081
`
`2082
`
`2083
`
`2084
`
`2085
`
`2086
`
`2086
`
`2087
`
`3
`
`
`
`Extensive Small
`Bowel Resection
`Gattex label
`Oley Foundation
`1994 - North
`American Home
`Parenteral
`NPS 2011 - NPS
`Pharmaceuticals
`Announces
`Completion of
`Treatment Phase in
`STEPS
`Seeking Alpha -
`CEO Discusses Q1
`2013 Results
`Amiot 2013 -
`Determinants of
`home parenteral
`nutrition
`dependence
`McKeage 2015 -
`Teduglutide - A
`Guide to its Use in
`SBS
`FDA 2015 - Orange
`Book Approved
`Drug Products with
`Therapeutic
`Equivalence
`Evaluations
`Jeppesen 2014 -
`Spectrum of short
`bowel syndrome in
`adults - Intestinal
`insufficiency to
`intestinal failure
`AGA 2003 -
`Technical Review
`on Short Bowl
`Syndrome and
`Intestinal
`Transplantation
`Jeppesen 1999 -
`Quality of life in
`patients receiving
`home parenteral
`nutrition
`Jeppesen 2011 -
`Randomised
`
`Exhibit
`
`Exhibit
`
`2088
`
`2089
`
`Exhibit
`
`2090
`
`Exhibit
`
`Exhibit
`
`2091
`
`2092
`
`Exhibit
`
`2093
`
`Exhibit
`
`2094
`
`Exhibit
`
`2095
`
`Exhibit
`
`2096
`
`Exhibit
`
`Exhibit
`
`2097
`
`2098
`
`4
`
`
`
`placebo-controlled
`trial of teduglutide
`in
`ADA 2013 -
`Economic Cost of
`Diabetes in the US
`in 2012
`Rodrigues 2011 -
`Short Bowel
`Syndrome
`Thompson 2012 -
`Current
`Management of
`SBS
`Jeppesen 2012 -
`Teduglutide
`Reduces Need for
`Parenteral Support
`Among Patients
`with SBS
`Seeking Alpha -
`CEO Discusses Q2
`2013 Results
`Seeking Alpha -
`CEO Discusses Q3
`2013 Results
`Seeking Alpha -
`CEO Discusses Q4
`2013 Results
`Shire 2015 - Q3
`2015 Results
`Shire 2015 - Q3
`2015 Results
`Wolters Kluwer
`Price Data
`NPS
`Pharmaceuticals'
`(NPSP) CEO
`Francois Nader on
`Q1 2014 Results -
`Earnings Call
`Transcript
`Seeking Alpha -
`CEO Francois
`Nader on Q2 2014
`Results
`Seeking Alpha -
`CEO Francois
`Nader on Q3 2014
`
`Exhibit
`
`Exhibit
`
`Exhibit
`
`2099
`
`2100
`
`2101
`
`Exhibit
`
`2102
`
`Exhibit
`
`Exhibit
`
`Exhibit
`
`Exhibit
`
`Exhibit
`
`Exhibit
`
`2103
`
`2104
`
`2105
`
`2106
`
`2107
`
`2108
`
`Exhibit
`
`2109
`
`Exhibit
`
`Exhibit
`
`2110
`
`2111
`
`5
`
`
`
`Results
`NPS 2014 10-K
`Shire 2015 - Q1
`2015 Results
`Shire 2015 - Q2
`2015 results
`Shire 2015 - SHPG
`Flemming Ornskov
`on Q3 2015 Results
`- Earnings Call
`Transcript
`Seeking Alpha 2013
`- NPS
`Pharmaceuticals
`CEO Discusses
`Yahoo Finance -
`NPSP Historical
`Prices
`NPS 2013 10-K
`Moon 2014 -
`Biotech selloff
`could be harbinger
`of further decline
`Reuters
`Ashton 2014 -
`Biotech Sell Off
`Drags NASDAQ-
`100 Down To 2-
`Year Lows
`Nasdaq - Overview
`for NBI
`Yahoo Finance -
`NBI Historical
`Prices
`Yahoo Finance -
`XBI Historical
`Prices
`Shire - Patient
`Assistance Program
`Gattex
`SP Capital IQ 2014
`- NPS
`Pharmaceuticals
`(NPSP)
`Osbourne 2014 -
`Natpara sails
`through panel
`despite headwind
`Shire 2015 - Q1
`
`Exhibit
`Exhibit
`
`Exhibit
`
`Exhibit
`
`Exhibit
`
`Exhibit
`
`Exhibit
`
`Exhibit
`
`Exhibit
`
`Exhibit
`
`Exhibit
`
`Exhibit
`
`Exhibit
`
`Exhibit
`
`Exhibit
`
`Exhibit
`
`2112
`2113
`
`2114
`
`2115
`
`2116
`
`2117
`
`2118
`
`2119
`
`2120
`
`2121
`
`2122
`
`2123
`
`2124
`
`2125
`
`2126
`
`2127
`
`6
`
`
`
`Exhibit
`
`Exhibit
`
`Exhibit
`
`Exhibit
`
`2015 10-Q
`FDA 2015 -
`Expiration Dating
`and Stability
`Testing for Human
`Gibson 2009 -
`Pharmaceutical
`Preformulation and
`Formulation
`Cohen 2000 - Many
`medicines are
`potent years past
`expiration dates
`Merck 2014 -
`Annual Report
`FDA CDER - Initial
`Quality Assessment Exhibit
`Herper 2012 -
`Inside The Secret
`World Of Drug
`Company Rebates -
`Forbes
`Shire - Sharps
`Disposal Gattex
`Shire - OnePath
`Support Program Exhibit
`Klick Health -
`Patient Support
`Programs
`FDA 2014 -
`Guidance on
`Devices for Home
`Use
`FDA - Approved
`Drug Products
`Gattex
`Adempas (riociguat)
`- Aim Patient
`Support Program
`Overview
`Celgene - Patient
`Support
`Merck 2006 -
`Annual Report
`Merck 2007 -
`Annual Report
`Merck 2008 -
`Annual Report
`Merck 2009 -
`
`Exhibit
`
`Exhibit
`
`Exhibit
`
`Exhibit
`
`Exhibit
`
`Exhibit
`
`Exhibit
`
`Exhibit
`
`Exhibit
`
`Exhibit
`Exhibit
`
`2128
`
`2129
`
`2130
`
`2131
`
`2132
`
`2133
`
`2134
`
`2135
`
`2136
`
`2137
`
`2138
`
`2139
`
`2140
`
`2141
`
`2142
`
`2143
`2144
`
`7
`
`
`
`Annual Report
`Part 1 Merck 2010 -
`Annual Report
`Part 2 Merck 2010 -
`Annual Report
`Part 1 Merck 2011 -
`Annual Report
`Merck 2012 -
`Annual Report
`Part 2 Merck 2011 -
`Annual Report
`
`Exhibit
`
`Exhibit
`
`Exhibit
`
`Exhibit
`
`Exhibit
`
`2145
`
`2145
`
`2146
`
`2147
`
`2146
`
`Questions regarding this receipt should be directed to the Patent Trial and Appeal Board at 571-272-7822.
`This e-mail is computer-generated. Do not reply because this e-mail address is not monitored.
`
`8