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 IPR2015-00990
`Patent 7,056,886
`
`____________
`
`PATENT OWNER’S UPDATED EXHIBIT LIST
`
`27900106v1
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`

`
`TABLE OF EXHIBITS
`
`Description
`
`2019
`
`2020
`
`2021
`
`2022
`
`2023
`
`Ex.
`No.
`2001 NPS Pharmaceuticals, Inc.’s Requests for Production to Petitioner
`2002 NPS Pharmaceuticals, Inc.’s Interrogatories to Petitioner
`2003 NPS Pharmaceuticals, Inc.’s Topics for Examination of Petitioner
`2004 General Hedge Fund Structure & Regulation
`2005 RPI Diagram
`2006 Form ADV Brochure of HCM (Mar. 30, 2015)
`2007 Form ADV of HCM (Mar. 30, 2015)
`2008 Annual Report of HCM (July 8, 2013)
`2009 Amended Form D of HCOP (May 12, 2014)
`2010 Amended Form D of HCP (May 12, 2014)
`2011 Credes Onshore Form D (Jan. 14, 2015)
`2012 Credes Onshore Delaware Secretary of State Website Printout
`2013 HCMF Cayman Islands Search Report
`2014 Credes Offshore Form D (Jan. 14, 2015)
`2015 Credes Offshore Caymans Search Report
`2016 Form D of HOF (April 9, 2015)
`2017 Certificate of Formation of IPNav (Nov. 13, 2007)
`2018 Certificate of Formation of nXnP (Sept. 24, 2014)
`Ed Silverman, Innovate or Else: Kyle Bass Strikes Again and Challenges
`Shire Patents, Wall Street Journal (April 2, 2015)
`Robert Cyran, Kyle Bass Wields New Weapon in Challenging Drug
`Makers, The New York Times (February 11, 2015)
`Joseph Walker and Rob Copeland, New Hedge Fund Strategy: Dispute the
`Patent, Short the Stock, Wall Street Journal (April 7, 2015)
`Julia La Roche, Hedge Fund Manager Kyle Bass is Going After Big
`Pharma and Its “BS Patents,” Business Insider (Jan. 7, 2015)
`Julia La Roche, Hedge Fund Manager Kyle Bass is Going After Big
`Pharma and Its “BS Patents,” Business Insider Australia (Jan. 8, 2015)
`Delaware Secretary of State Business Entity Search Printout for Coalition
`Entities
`2024
`2025 Cayman Islands Search Report of HOM
`2026 Cayman Islands Search Report of HOF
`2027 GATTEX® Product Label
`Lehninger et al., Principles of Biochemistry, 2nd ed., Chapters 5-7 & 18, pp.
`111-197 & 542-597 (1993)
`
`2028
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`27900106v1
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`

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`Ex.
`No.
`
`Description
`
`2035
`
`2038
`
`2039
`
`2040
`
`Voet and Voet, Biochemistry, 2nd ed., Chapters 7 & 14, pp. 141-90 & 371-
`410 (1995)
`2029
`2030 Purves et al., Life: The Science of Biology, 3rd ed., Ch. 3, pp. 40-59 (1992)
`2031 NPS Pharmaceuticals , Inc. Form10-K 2014
`2032 Email from Jeff Blake to Counsel for Patent Owner
`2033 Declaration of Christopher E. Kirkpatrick
`2034 Declaration of Erich Spangenberg
`The Wall Street Journal – New Hedge Fund Strategy: Challenge the Patent,
`Short the Stock
`The Wall Street Journal – Innovate or Else: Kyle Bass Strikes Again and
`Challenges Shire Patents
`2036
`2037 Hayman Capital Management, L.P. Form ADV Part 2A Brochure
`Brubaker and Drucker, Structure-Function of the Glucagon Receptor
`Family of G-Protein Coupled Receptors: The Glucagon, GIP, GLP-1, and
`GLP-2 Receptors, Receptors and Channels, vol. 8, pp. 179-188 (2002)
`Chaturvedi, A Report on Stability of Polypeptides and Proteins, Birla
`Institute of Technology and Science Pilani (Rajasthan) (August 2009)
`Declaration of John F. Carpenter, Ph.D. in Support of Patent Owner’s
`Response
`Declaration of Gordon Rausser, Ph.D. Under 37 C.F.R. § 1.68 in Support of
`Patent Owner’s Response to the Petition
`2041
`2042 Transcript of Video Deposition of Anthony Palmieri III, Ph.D.
`2043 CV of John F. Carpenter, Ph.D.
`2044 CV of Gordon Rausser, Ph.D.
`Jackson et al., “Stable liquid glucagon formulations for rescue treatment
`and bi-hormonal closed-loop pancreas,” Curr. Diab. Rep. 12(6) Dec. 2012
`705-710.
`Onoue et al., “Mishandling of therapeutic Peptide Glucagon Generates
`Amyloidogenic Fibrils,” Parm. Res. 21(7) July 2004
`2046
`2047 U.S. Pharmacopeia 24, 774-77 (1999)
`Joshi et al., “The degradation pathways of Glucagon in Acidic Solutions,”
`Int’l J. Pharmaceutics, 203(1-2) August 2000 115-125, Abstract; Fang et
`al., “Effects of Excipients on the Chemical and Physical Stability of
`Glucagon during Freeze-Drying and Storage in Dried Formulations,”
`Pharm. Res. 29:3278-3291 (2012)
`Fang et al., Effects of Excipients on the Chemical and Physical Stability of
`Glucagon during Freeze-Drying and Storage in Dried Formulations, Pharm.
`
`2045
`
`2048
`
`2049
`
`27900106v1
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`

`
`Ex.
`No.
`
`Description
`
`2050
`
`2051
`
`2052
`
`2060
`
`2063
`
`Res. 29:3278-3291 (2012)
`Blundell, “The Conformation of Glucagon,” Handbook of Experimental
`Pharmacology, vol. 66, 37-56 (1983)
`Boesch et al., “1H Nuclear-Magnetic-Resonance Studies of the Molecular
`Conformation of Monomeric Glucagon in Aqueous Solution,” Eur. J.
`Biochem., 91, 209-214 (1978)
`Akers, “Excipient-Drug Interactions in Parenteral Formulations”, Journal of
`Pharmaceutical Sciences, Vol. 91, No. 11, November 2002
`U.S. Pharmacopeia 788, “Particulate Matter In Injections”, The United
`States Pharmacopeial Convention (2011)
`2053
`2054 Remington’s Pharmaceutical Sciences, 18th Ed., 1549-51 (1990)
`2055 U.S. Patent Publication No. 2013/0310314
`2056 Process Validation and/or Evaluation for Gattex
`2057 Annex1 Summary of Product Characteristics
`2058 Orange Book Listing for Gattex
`2059 Eli Lilly & Co., “Glucagon for Injection (rDNA Origin)” (2012)
`Al-Hussein et al., “Investigation of Histidine Stabilizaing Effects on LDH
`During Freeze-Drying”, Journal of Pharmaceutical Sciences, Vol. 102, No.
`3 (2013)
`Izutsu et al., “Freeze-Drying of Proteins in Glass Solids Formed by Basic
`Amino Acids and Dicarboxylic Acids”, Chem. Pharm. Bull. 57(1), 43-48
`(2009)
`2061
`2062 U.S. Pharmacopeia 23, 1650-51 (1995)
`Center for Drug Evaluation and Research, Application
`Number:203441Orig1s000, Chemistry Review(s)
`U.S. Food and Drug Administration, “FDA Approved Drug Products —
`Zorbtive.” Accessed January 19, 2016 at https://www.accessdata.fda.gov
`2064
`2065 Shire, “Shire completes acquisition of NPS Pharma,” February 21, 2015
`Engellenner, Tom, “Bass Goes Fishing: Trouble Ahead for Pharma, Or For
`Hedge-Fund Trolls?” Forbes July 15, 2015
`Walker, Joseph and Rob Copeland, “New Hedge Fund Strategy: Dispute
`the Patent, Short the Stock,” Wall Street Journal April 7, 2015
`Wieczner, Jen, “Why Drug Price Controversy Is Great News for this Hedge
`Fund Manager,” Fortune September 30, 2015
`Buchman, Alan, “Etiology and Initial Management of Short Bowel
`Syndrome,” Gastroenterology 130, no. 2 (2006): S5–S15
`2069
`2070 Pirona, Loris, et al., “Espen endorsed recommendations. Definition and
`-3-
`
`2066
`
`2067
`
`2068
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`27900106v1
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`

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`Ex.
`No.
`
`Description
`
`2071
`
`2072
`
`2073
`
`classification of intestinal failure in adults,” Journal of Clinical Nutrition
`34 (2015):171–180
`O’Keefe, Stephen, “Short Bowel Syndrome and Intestinal Failure:
`Consensus Definitions and Overview,” Clinical Gastroenterology and
`Hepatology 4, no. 1 (2006): 6–10
`Buchman, Alan, “The Clinical Management of Short Bowel Syndrome:
`Steps to Avoid Parenteral Nutrition,” Nutrition 13, no. 10 (1997): 907–913
`NPS, “Developing orphan products for patients with rare gastrointestinal
`and endocrine disorders,” August 2012
`Hofstetter, Steven, Lee Stern and Jacob Willet, “Key issues in addressing
`the clinical and humanistic burden of short bowel syndrome in the US,”
`Current Medical Research and Opinion 29, no. 5 (2013)
`2074
`2075 Shire, “Gattex Physician ATU Final Report,” October 22, 2015
`O’Keefe, Stephen, “Nutritional Issues in the Short Bowel Syndrome – Total
`Parenteral Nutrition, Enteral Nutrition and the Role of Transplantation,”
`Nestle Nutrition Institute Workshop Series 82 (2015): 75–90
`Tee, Cheng, Katharina Wallis and Simon Gabe, “Emerging Treatment
`Options for Short Bowel Syndrome: Potential Role of Teduglutide,”
`Clinical and Experimental Gastroenterology 4 (2011): 189–196
`Naberhuis, Jane and Kelly Tappenden, “Teduglutide for Safe Reduction of
`Parenteral Nutrient And/or Fluid Requirements in Adults: A Systematic
`Review,” Journal of Parenteral and Enteral Nutrition (2015)
`Buchman, Alan, “Teduglutide and Short Bowel Syndrome: Every Night
`without Parenteral Fluids Is a Good Night,” Gastroenterology 143, no. 6
`(October 2012): 1416–1420
`U.S. Food and Drug Administration, “FDA Approved Drug Products —
`Zorbtive.” Accessed January 19, 2016 at https://www.accessdata.fda.gov.
`Crohn’s and Colitis Foundation of America, “Short Bowel Syndrome and
`Crohn’s Disease,” July 2013
`Donohoe, Claire and John Reynolds, “Short Bowel Syndrome,” The
`Surgeon 8 (2010): 270–279
`U.S. Food and Drug Administration, “Zorbtive — somatropin (rDNA
`origin) for injection,” December 1, 2003
`Wales, P., et al., “Human Growth Hormone and Glutamine for Patients
`with Short Bowel Syndrome (Review),” The Cochrane Library, 6 (2010):
`1–30, p. 2 ( “Wales (2010)”)
`2084
`2085 Serono 2005 Annual Report
`
`2076
`
`2077
`
`2078
`
`2079
`
`2080
`
`2081
`
`2082
`
`2083
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`27900106v1
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`Description
`
`2087
`
`2088
`
`2089
`
`2090
`
`2091
`
`2092
`
`2093
`
`Ex.
`No.
`2086 Merck KGaA Annual Reports for 2013
`Keller, Jutta, Heidi Panter, and Peter Layer, “Management of the Short
`Bowel Syndrome after Extensive Small Bowel Resection,” Best Practice
`and Research Clinical Gastroenterology 18, no. 5 (2004): 977-992
`U.S. Food and Drug Administration, “Highlights of Prescribing Information
`— Gattex” June 26, 2014 (“Gattex label”)
`The Oley Foundation, “North American Home Parenteral and Enteral
`Patient Registry: Annual Report,” 1994
`NPS, “NPS Pharmaceuticals Announces Completion of Treatment Phase in
`STEPS Registration Study of GATTEX in Short Bowel Syndrome,”
`(January 10, 2011)
`NPS, “NPS Pharmaceuticals' CEO Discusses Q1 2013 Results Earnings
`Call Transcript” (May 9, 2013)
`Amiot, Aurelien, Bernard Messing, Olivier Corcos, Yves Panis, and
`Francisca Joly, “Determinants of Home Parenteral Nutrition Dependence
`and Survival of 268 Patients with Non-malignant Short Bowel Syndrome,”
`Clinical Nutrition 20, no. 12 (2014): 368–74
`McKeage, Kate, “Teduglutide: A Guide to its Use in Short Bowel
`Syndrome,” Clinical Drug Investigation 35, no. 5 (April 2015): 335–340
`U.S. Food and Drug Administration, “Orange Book: Approved Drug
`Products with Therapeutic Equivalence Evaluations [Gattex].” Accessed
`December 8, 2015 at http://www.accessdata.fda.gov/scripts/cder/ob/docs/
`patexclnew.cfm?Appl_No=203441&Product_No=001&table1=OB_Rx
`Jeppesen, Palle, “Spectrum of Short Bowel Syndrome in Adults: Intestinal
`Insufficiency to Intestinal Failure,” Journal of Parenteral and Enteral
`Nutrition vol. 38, suppl. 1 (May 2014): 8S–13S (“Jeppesen (2014)”)
`American Gastroenterological Association, “Technical Review on Short
`Bowl Syndrome and Intestinal Transplantation,” Gastroenterology 124
`(2003): 1111–1134
`Jeppesen, P., E. Langholz and P. Mortensen, “Quality of Life in Patients
`Receiving Home Parenteral Nutrition,” Gut 44 (1999): 844–852 (“Jeppesen
`(1999)”)
`Jeppesen, Palle, et al., “Randomised Placebo-controlled Trial of
`Teduglutide in Reducing Parenteral Nutrition and/or Intravenous Fluid
`Requirements in Patients with Short Bowel Syndrome,” Gut 60 (2011):
`902–914 (“Jeppesen (2011)”)
`2098
`2099 American Diabetes Association, “Economic Costs of Diabetes in the U.S.
`
`2094
`
`2095
`
`2096
`
`2097
`
`27900106v1
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`

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`Ex.
`No.
`
`Description
`
`2100
`
`2101
`
`2102
`
`2103
`
`2104
`
`2105
`
`2106
`
`2109
`
`2110
`
`in 2012,” Diabetes Care 36 (April 2013): 1033–1046
`Rodrigues, Gabriel and Prasad Seetharam, “Short Bowel Syndrome: A
`Review of Management Options,” Saudi Journal of Gastroenterology 17,
`no. 4 (2011): 229–235
`Thompson, Jon, Fedja Rochling, Rebecca Weseman, and David Mercer,
`“Current Management of Short Bowel Syndrome,” Current Problems in
`Surgery 49, no. 2 (2012): 52–115
`Jeppesen, Palle, et al., “Teduglutide Reduces Need for Parenteral Support
`among Patients with Short Bowel Syndrome with Intestinal Failure.”
`Gastroenterology 143, no. 6 (2012): 1473–1481
`NPS, “NPS Pharmaceuticals’ CEO Discusses Q2 2013 Results - Earnings
`Call Transcript” (August 8, 2013)
`NPS, “NPS Pharmaceuticals’ CEO Discusses Q3 2013 Results - Earnings
`Call Transcript” (November 6, 2013)
`NPS, “NPS Pharmaceuticals’ CEO Discusses Q4 2013 Results - Earnings
`Call Transcript” (February 19, 2014)
`Shire, 2015, “Progressing our transformation to a leading global biotech,
`whilst upgrading full year earnings guidance” (July 23, 2015)
`Shire, 2015, “Q3 2015 Results – Progressing our transformation to a
`leading global biotech” (October 23, 2015)
`2107
`2108 Wolters Kluwer Price Rx Data
`NPS, "NPS Pharmaceuticals' (NPSP) CEO Francois Nader on Q1 2014
`Results - Earnings Call Transcript" (May 8, 2014)
`NPS, "NPS Pharmaceuticals' (NPSP) CEO Francois Nader on Q2 2014
`Results - Earnings Call Transcript" (August 6, 2014)
`NPS, "NPS Pharmaceuticals' (NPSP) CEO Francois Nader on Q3 2014
`Results - Earnings Call Transcript" (November 10, 2014)
`2111
`2112 NPS, 10-K for 2014
`Shire, 2015, “Q1 2015 Results – Shire delivers strong revenue growth and
`cash generation; 20% increase in Non GAAP earnings per ADS" (April 30,
`2015)
`Shire, 2015, “Q2 2015 Results – Progressing our transformation to a
`leading global biotech, whilst upgrading full year earnings guidance" (July
`23, 2015)
`Shire, “Shire Plc (SHPG) Flemming Ornskov on Q3 2015 Results –
`Earnings Call Transcript” (October 23, 2015)
`2115
`2116 Seeking Alpha, “NPS Pharmaceuticals’ CEO Discusses FDA Approval and
`
`2113
`
`2114
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`Ex.
`No.
`
`Description
`
`2119
`
`2120
`
`2121
`
`Commercial launch of Gattex (Transcript),” January 2, 2013
`2117 Yahoo Finance, NPS Pharmaceuticals historical stock prices, 2010-2015
`2118 NPS Form 10-Ks for 2013
`Moon, Angela, “Biotech selloff could be harbinger of further decline.”
`Reuters, March 21, 2014. Accessed January 19, 2016 at
`http://www.reuters.com/article/us-biotech-stocks-options-
`idUSBREA2K20020140321
`Ashton, Bill, “Biotech Sell Off Drags NASDAQ-100 Down To 2-Year
`Lows,” Bidness Etc, April 11, 2014. Accessed January 5, 2016 at
`http://www.bidnessetc.com/21468-news-analysis-biotech-sell-off-drags-
`nasdaq-100-down-to-2-year-lows/
`Nasdaq, “Overview of NASDAQ Biotechnology (NBI).” Accessed January
`5, 2016 at https://indexes.nasdaqomx.com/Index/Overview/NBI
`Yahoo Finance, NASDAQ Biotechnology historical stock prices, 2010-
`2015
`2122
`2123 Yahoo Finance, SPDR S&P Biotech ETF historical stock prices, 2010-2015
`Gattex. “Patient assistance program.” Accessed December 28, 2015 at
`https://www.gattex.com/patient-support/patient-assistance-program.aspx
`1 S&P Capital IQ. “NPS Pharmaceuticals (NPSP) $32.25 down $0.35...”
`Ameritrade, June 6, 2014, accessed December 22, 2015 at
`https://research.tdameritrade.com/grid/public/markets/news/story.asp?docK
`ey= 1214ALERT5_632014&category=Options
`Osbourne, Randy. “Natpara sails through panel despite headwind; NPS
`Pharma gets an 8-5 ‘yes’ vote in hypoparathyroidism.” Bioworld,
`September 15, 2014, accessed December 22, 2015 at
`http://www.bioworld.com/content/natpara-sails-through-panel-despite-
`headwind-npsp-harma-gets-8-5-yes-vote-hypoparathyroidism
`2126
`2127 Shire, Q1 2015 Form 10-Q
`U.S. Food and Drug Administration, “Expiration Dating and Stability
`Testing for Human Drug Products,” January 26, 2015
`Mark Gibson, Ed., 2009, Pharmaceutical Preformulation and Formulation,
`Second Ed., New York: Informa Healthcare
`Cohen, Laurie, “Many medicines are potent years past expiration dates,”
`Wall Street Journal, March 28, 2000
`2130
`2131 Merck KGaA Annual Reports for 2014
`2132 FDA CDER Initial Quality Assessment
`2133 Herper, Matthew, “Inside the secret world of drug company rebates,”
`
`2124
`
`2125
`
`2128
`
`2129
`
`27900106v1
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`
`Ex.
`No.
`
`Description
`
`2134
`
`2135
`
`2136
`
`2137
`
`2138
`
`2139
`
`Forbes: Pharma & Healthcare, May 10, 2012. Accessed January 19, 2016
`at http://www.forbes.com/sites/matthewherper/2012/05/10/why-
`astrazeneca-gives-insurers-60-discounts-on-nexiums-list-
`price/#2715e4857a0b34bd5f0a4fd6
`Gattex. “Sharps Disposal.” Accessed December 28, 2015 at
`https://www.gattex.com/patient-support/sharps-disposal.aspx;
`Shire. “OnePath.” Accessed December 28, 2015 at
`https://www.shire.com/patients/patient-services/onepath
`Klick Health, “Patient Support Programs,” Accessed December 28, 2015 at
`https://www.klick.com/health/about/solutions/patient-support-programs/
`U.S. Food and Drug Administration, “Design Considerations for Devices
`Intended for Home Use – Guidance for the Industry and Food and Drug
`Administration Staff,” November 24, 2014
`U.S. Food and Drug Administration, “FDA Approved Drug Products —
`Gattex.” Accessed January 19, 2016 at https://www.accessdata.fda.gov/
`Adempas, “Support Every Step of the Way.” Accessed December 28, 2015
`at http://www.adempas-us.com/support-every-step-of-the-way/
`Celgene, “Celgene Patient Support.” Accessed December 28, 2015 at
`https://www.celgenepatientsupport.com/
`2140
`2141 Merck KGaA Annual Reports for 2006
`2142 Merck KGaA Annual Reports for 2007
`2143 Merck KGaA Annual Reports for 2008
`2144 Merck KGaA Annual Reports for 2009
`2145 Merck KGaA Annual Reports for 2010
`2146 Merck KGaA Annual Reports for 2011
`2147 Merck KGaA Annual Reports for 2012
`Declaration of John F. Carpenter, Ph.D. in Support of Patent Owner’s
`Response (Redacted)
`Declaration of Gordon Rausser, Ph.D. Under 37 C.F.R. § 1.68 in Support of
`Patent Owner’s Response to the Petition (Redacted)
`2149
`2150 Protective Order
`2151 Declaration of Matthew Hu
`2152 PRPS Email 1/20/16 11:30 PM
`2153 PRPS Email 1/20/16 11:35 PM
`2154 PRPS Email 1/20/16 11:42 PM
`2155 PRPS Email 1/20/16 11:49 PM
`2156 PRPS Email 1/20/16 11:58 PM
`
`2148
`
`27900106v1
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`Description
`
`Ex.
`No.
`2157 PRPS Email 1/21/16 12:02 AM
`2158 PRPS Email 1/21/16 3:50 AM
`2159 PRPS Email 1/21/16 2:25 AM
`2160 Declaration of Joseph R. Robinson
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