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
`
`_____________________
`
`IPR2015-01093
`Patent No. 7,056,886
`_____________________
`
`
`
`PETITIONER’S OBJECTIONS TO PATENT OWNER’S EXHIBITS
`SUBMITTED WITH ITS PATENT OWNER’S RESPONSE
`
`
`
`1
`
`
`
`
`
`
`
`
`
`
`_____________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________________
`
`
`
`COALITION FOR AFFORDABLE DRUGS II LLC
`Petitioner
`
`v.
`
`
`
`NPS PHARMACEUTICALS, INC.
`Patent Owner
`
`_____________________
`
`IPR2015-01093
`Patent No. 7,056,886
`_____________________
`
`
`
`PETITIONER’S OBJECTIONS TO PATENT OWNER’S EXHIBITS
`SUBMITTED WITH ITS PATENT OWNER’S RESPONSE
`
`
`
`1
`
`
`
`
`
`
`
`
`
`
`
`Pursuant to 37 C.F.R. § 42.64, Petitioner Coalition For Affordable Drugs II
`
`LLC serves the following objections to exhibits submitted with Patent Owner NPS
`
`Pharmaceuticals, Inc.’s Response (Paper 31):
`
`Description
`
`Objections
`
`
`
`Declaration of Gordon
`Rausser, Ph.D.
`
`Jackson et al., Curr Diab
`Rep. 2012 December ;
`12(6): 705–710.
`Onoue et al.,
`Pharmaceutical Research,
`Vol. 21, No. 7, July 2004
`The United States
`Pharmacopeia Official
`Monographs (2000)
`Joshi et al., International
`Journal of Pharmaceutics
`203 (2000) 115–125
`Fang et al., Pharm Res
`(2012) 29:3278–3291
`T.L. Blundell, Chapter 3,
`The Conformation of
`Glucagon (1983)
`Boesch et al., Eur. J.
`Biochem. 91, 209-214
`(1978)
`Declaration of John F.
`Carpenter, Ph.D.
`
`Relevancy; Fed. R. Evid. 401, 402 and 403
`Hearsay; Fed. R. Evid. 802
`Improper expert testimony; Fed. R. Evid.
`702, 703
`Original Document Requirement; Fed. R.
`Evid. 1002
`Relevancy; Fed. R. Evid. 401, 402, and 403
`Hearsay; Fed. R. Evid. 802
`
`Relevancy; Fed. R. Evid. 401, 402, and 403
`Hearsay; Fed. R. Evid. 802
`
`Hearsay; Fed. R. Evid. 802
`
`
`Hearsay; Fed. R. Evid. 802
`
`
`Relevancy; Fed. R. Evid. 401, 402, and 403
`Hearsay; Fed. R. Evid. 802
`Hearsay; Fed. R. Evid. 802
`
`
`Hearsay; Fed. R. Evid. 802
`
`
`Relevancy; Fed. R. Evid. 401, 402 and 403
`Hearsay; Fed. R. Evid. 802
`Improper expert testimony; Fed. R. Evid.
`2
`
`Patent
`Owner
`Ex.
`No.
`2041
`
`2045
`
`2046
`
`2047
`
`2048
`
`2049
`
`2050
`
`2051
`
`2051
`
`
`
`
`
`2052
`
`2053
`
`2054
`
`2055
`
`2056
`
`Akers, Journal of
`Pharmaceutical Sciences,
`Vol. 91, No. 11, November
`2002
`Revision Bulletin
`Official October 1, 2011,
`<788> Particulate Matter In
`Injections
`Remington’s
`Pharmaceutical Sciences,
`18th Edition, pp. 1549-1551
`United States Patent
`Application Publication
`2013/0310314 published
`November 21, 2013
`Process Validation
`and/or Evaluation
`for Gattex
`
`2057
`
`Annex I – Summary of
`Product Characteristics
`
`2058
`
`Orange Book: Gattex Kit
`
`Information for the
`Physician, Glucagon for
`Injection (rDNA Origin)
`
`Al-Hussein et al., Journal of
`Pharmaceutical Sciences,
`Vol. 102, No. 3, March
`2013
`Izutsu et al., Chem. Pharm.
`Bull. 57(1) 43-48 (2009)
`The United States
`
`2059
`
`2060
`
`2061
`
`2062
`
`
`
`702, 703
`Original Document Requirement; Fed. R.
`Evid. 1002
`Relevancy; Fed. R. Evid. 401, 402, and 403
`Hearsay; Fed. R. Evid. 802
`
`
`Relevancy; Fed. R. Evid. 401, 402, and 403
`Hearsay; Fed. R. Evid. 802
`Unauthenticated; Fed. R. Evid. 901
`
`Hearsay; Fed. R. Evid. 802
`Incomplete; Fed. R. Evid. 106
`
`Relevancy; Fed. R. Evid. 401, 402, and 403
`Hearsay; Fed. R. Evid. 802
`
`
`Hearsay; Fed. R. Evid. 802
`Unauthenticated; Fed. R. Evid. 901
`Original Document Requirement; Fed. R.
`Evid. 1002
`Hearsay; Fed. R. Evid. 802
`Unauthenticated; Fed. R. Evid. 901
`Original Document Requirement; Fed. R.
`Evid. 1002
`Unauthenticated; Fed. R. Evid. 901
`
`Hearsay; Fed. R. Evid. 802
`Unauthenticated; Fed. R. Evid. 901
`Original Document Requirement; Fed. R.
`Evid. 1002
`Relevancy; Fed. R. Evid. 401, 402, and 403
`Hearsay; Fed. R. Evid. 802
`
`
`Relevancy; Fed. R. Evid. 401, 402, and 403
`Hearsay; Fed. R. Evid. 802
`Hearsay; Fed. R. Evid. 802
`
`3
`
`
`
`Pharmacopeia, USP 23, pp.
`1650-1651 (1995)
`Center for Drug Evaluation
`and Research, Application
`Number: 203441Orig1s000,
`Chemistry Review(s)
`
`Label and Approval
`History, Zorbtive
`
`Shire Completes
`Acquisition of NPS
`Pharma, February 21, 2015
`https://www.shire.com/new
`sroom/2015/february/shire-
`completes-acquisition-of-
`nps-pharma
`Tom Engellenner, Bass
`Goes Fishing: Trouble
`Ahead For Pharma, Or For
`Hedge-Fund Trolls?
`http://www.forbes.com/site
`s/danielfisher/2015/07/15/b
`ass-goes-fishing-trouble-
`ahead-for-pharma-or-for-
`hedge-fundtrolls/#
`2715e4857a0b47e56d7f225
`e
`New Hedge Fund Strategy:
`Dispute the Patent, Short
`the Stock – WSJ
`Jen Wieczner, Why drug
`price controversy is great
`news for this hedge fund
`Manager,
`http://fortune.com/2015/09/
`30/drug-prices-stocks-kyle-
`bass/
`Alan L. Buchman,
`
`2063
`
`2064
`
`2065
`
`2066
`
`2067
`
`2068
`
`2069
`
`
`
`Incomplete; Fed. R. Evid. 106
`
`Hearsay; Fed. R. Evid. 802
`Unauthenticated; Fed. R. Evid. 901
`Original Document Requirement; Fed. R.
`Evid. 1002
`Incomplete; Fed. R. Evid. 106
`Relevancy; Fed. R. Evid. 401, 402, and 403
`Hearsay; Fed. R. Evid. 802
`Unauthenticated; Fed. R. Evid. 901
`Hearsay; Fed. R. Evid. 802
`Unauthenticated; Fed. R. Evid. 901
`
`Hearsay; Fed. R. Evid. 802
`
`
`Hearsay; Fed. R. Evid. 802
`
`
`Hearsay; Fed. R. Evid. 802
`
`
`Relevancy; Fed. R. Evid. 401, 402, and 403
`
`4
`
`
`
`Hearsay; Fed. R. Evid. 802
`
`Relevancy; Fed. R. Evid. 401, 402, and 403
`Hearsay; Fed. R. Evid. 802
`
`Relevancy; Fed. R. Evid. 401, 402, and 403
`Hearsay; Fed. R. Evid. 802
`
`Hearsay; Fed. R. Evid. 802
`
`Relevancy; Fed. R. Evid. 401, 402, and 403
`Hearsay; Fed. R. Evid. 802
`Unauthenticated; Fed. R. Evid. 901
`Original Document Requirement; Fed. R.
`Evid. 1002
`
`Relevancy; Fed. R. Evid. 401, 402, and 403
`Hearsay; Fed. R. Evid. 802
`
`
`Relevancy; Fed. R. Evid. 401, 402, and 403
`Lack of Foundation; Fed. R. Evid 602, 701,
`702
`Hearsay; Fed. R. Evid. 802
`Unauthenticated; Fed. R. Evid 901
`Original Document Requirement; Fed. R.
`Evid. 1002
`Relevancy; Fed. R. Evid. 401, 402, and 403
`Hearsay; Fed. R. Evid. 802
`
`
`GASTROENTEROLOGY
`2006;130:S5–S15
`Pironi et al., Clinical
`Nutrition 34 (2015) 171-
`180
`O’Keefe et al., CLINICAL
`GASTROENTEROLOGY
`AND HEPATOLOGY
`2006;4:6–10
`Alan L. Buchman, Nutrition
`Vol. 13, No. 10, 1997
`NPS Pharmaceuticals,
`Developing Orphan
`Products for Patients with
`Rare Gastrointestinal and
`Endocrine Disorders,
`August 2012
`Hofstetter et al., Current
`Medical Research and
`Opinion Vol. 29, No. 5,
`2013, 495–504
`Gattex Physician Report
`
`2070
`
`2071
`
`2072
`
`2073
`
`2074
`
`2075
`
`2076 Meier RF, Reddy BR,
`Soeters PB (eds): The
`Importance of Nutrition as
`an Integral Part of Disease
`Management. Nestlé Nutr
`Inst Workshop Ser, vol 82,
`pp 75–90, 2015, Nutritional
`Issues in the Short Bowel
`Syndrome – Total
`Parenteral Nutrition,
`Enteral Nutrition and the
`
`
`
`5
`
`
`
`Role of
`Transplantation by
`Stephen J.D. O’Keefe
`Tee et al., Clinical and
`Experimental
`Gastroenterology 2011:4
`189–196
`Naberhuis et al.,
`“Teduglutide for Safe
`Reduction of Parenteral
`Nutrient And/or Fluid
`Requirements
`in Adults: A Systematic
`Review,” Journal of
`Parenteral and Enteral
`Nutrition
`(2015)
`Alan L. Buchman,
`GASTROENTEROLOGY
`2012;143:1416–1434
`Label and Approval
`History, Zorbtive
`Crohn’s and Colitis
`Foundation of America,
`Short Bowel Syndrome and
`Crohn’s Disease, 2013
`Donohoe et al., The
`Surgeon 8 (2010) 270-279
`Zorbtive label
`
`2077
`
`2078
`
`2079
`
`2080
`
`2081
`
`2082
`
`2083
`
`Relevancy; Fed. R. Evid. 401, 402, and 403
`Hearsay; Fed. R. Evid. 802
`
`
`Relevancy; Fed. R. Evid. 401, 402, and 403
`Hearsay; Fed. R. Evid. 802
`
`
`Relevancy; Fed. R. Evid. 401, 402, and 403
`Hearsay; Fed. R. Evid. 802
`
`Hearsay; Fed. R. Evid. 802
`Unauthenticated; Fed. R. Evid. 901
`Relevancy; Fed. R. Evid. 401, 402, and 403
`Hearsay; Fed. R. Evid. 802
`Unauthenticated; Fed. R. Evid. 901
`
`Relevancy; Fed. R. Evid. 401, 402, and 403
`Hearsay; Fed. R. Evid. 802
`Hearsay; Fed. R. Evid. 802
`Unauthenticated; Fed. R. Evid. 901
`Incomplete; Fed. R. Evid. 106
`Hearsay; Fed. R. Evid. 802
`
`
`2084 Wales et al., Cochrane
`Database of Systematic
`Reviews 2010, Issue 6. Art.
`No.: CD006321.
`Serono Annual Report 2005 Hearsay; Fed. R. Evid. 802
`Unauthenticated; Fed. R. Evid. 901
`Original Document Requirement; Fed. R.
`Evid. 1002
`
`2085
`
`
`
`6
`
`
`
`2086 Merck Annual Report 2013 Hearsay; Fed. R. Evid. 802
`Unauthenticated; Fed. R. Evid. 901
`Original Document Requirement; Fed. R.
`Evid. 1002
`Relevancy; Fed. R. Evid. 401, 402, and 403
`Hearsay; Fed. R. Evid. 802
`
`
`2087
`
`Keller et al., Best Practice
`& Research Clinical
`Gastroenterology
`Vol. 18, No. 5, pp. 977–
`992, 2004
`Gattex label
`
`North American Home
`Parenteral and Enteral
`Nutrition Patient Registry,
`Annual Report with
`Outcome Profiles, 1985-
`1992, Special Feature: An
`Analysis of Hen Clinical
`Outcome in Patients with
`Neuromuscular Disorders
`of Swallowing, 1994, The
`Oley Foundation, Albany,
`New York
`NPS Pharmaceuticals
`Announces Completion of
`Treatment Phase
`in STEPS Registration
`Study of GATTEX in Short
`Bowel
`Syndrome
`Jan 10, 2011,
`http://ir.npsp.com/releasede
`tail.cfm?ReleaseID=829997
`NPS Pharmaceuticals' CEO
`Discusses Q1 2013 Results
`Earnings
`Call Transcript | Seeking
`Alpha, May 9, 2013
`Amiot et al., Clinical
`Nutrition 32 (2013) 368-
`
`2088
`
`2089
`
`2090
`
`2091
`
`2092
`
`
`
`Hearsay; Fed. R. Evid. 802
`Unauthenticated; Fed. R. Evid. 901
`Hearsay; Fed. R. Evid. 802
`Unauthenticated; Fed. R. Evid. 901
`Original Document Requirement; Fed. R.
`Evid. 1002
`
`
`Hearsay; Fed. R. Evid. 802
`Unauthenticated; Fed. R. Evid. 901
`
`
`Hearsay; Fed. R. Evid. 802
`Unauthenticated; Fed. R. Evid. 901
`
`
`Relevancy; Fed. R. Evid. 401, 402, and 403
`Hearsay; Fed. R. Evid. 802
`7
`
`
`
`374
`Kate McKeage, Clin Drug
`Investig (2015) 35:335–340
`Orange Book Patent and
`Exclusivity Search Results
`for Gattex
`Palle B. Jeppesen, Journal
`of Parenteral and Enteral
`Nutrition, Volume 38,
`Supplement 1, May 2014,
`8S–13S
`Buchman et al.,
`GASTROENTEROLOGY
`2003;124:1111–1134
`Jeppesen et al., Gut 1999;
`44:844–852
`Jeppesen et al., Gut 2011;
`60:902-914
`Economic Costs of
`Diabetes in the U.S.
`in 2012, Diabetes Care
`36:1033–1046, 2013
`Seetharam et al., Saudi J
`Gastroenterol. 2011 Jul-
`Aug; 17(4): 229–235.
`“Current Management of
`Short
`Bowel Syndrome,” Curr
`Probl Surg 2012;49:52-115.
`Jeppesen et al.,
`GASTROENTEROLOGY
`2012;143:1473–1481
`NPS Pharmaceuticals CEO
`Discusses Q2 2013 Results
`Earnings
`Call Transcript, Seeking
`Alpha, August 8, 2013
`NPS Pharmaceuticals' CEO
`Discusses Q3 2013 Results
`
`
`Relevancy; Fed. R. Evid. 401, 402, and 403
`Hearsay; Fed. R. Evid. 802
`Unauthenticated; Fed. R. Evid. 901
`
`
`Relevancy; Fed. R. Evid. 401, 402, and 403
`Hearsay; Fed. R. Evid. 802
`
`Relevancy; Fed. R. Evid. 401, 402, and 403
`Hearsay; Fed. R. Evid. 802
`
`Hearsay; Fed. R. Evid. 802
`
`Relevancy; Fed. R. Evid. 401, 402, and 403
`Hearsay; Fed. R. Evid. 802
`Relevancy; Fed. R. Evid. 401, 402, and 403
`Hearsay; Fed. R. Evid. 802
`
`Relevancy; Fed. R. Evid. 401, 402, and 403
`Hearsay; Fed. R. Evid. 802
`Incomplete; Fed. R. Evid. 106
`Relevancy; Fed. R. Evid. 401, 402, and 403
`Hearsay; Fed. R. Evid. 802
`
`Relevancy; Fed. R. Evid. 401, 402, and 403
`Hearsay; Fed. R. Evid. 802
`
`Hearsay; Fed. R. Evid. 802
`Unauthenticated; Fed. R. Evid. 901
`Original Document Requirement; Fed. R.
`Evid. 1002
`
`Hearsay; Fed. R. Evid. 802
`Unauthenticated; Fed. R. Evid. 901
`
`8
`
`2093
`
`2094
`
`2095
`
`2096
`
`2097
`
`2098
`
`2099
`
`2100
`
`2101
`
`2102
`
`2103
`
`2104
`
`
`
`
`
`Earnings
`Call Transcript, Seeking
`Alpha, November 6, 2013
`NPS Pharmaceuticals' CEO
`Discusses Q4 2013 Results
`Earnings
`Call Transcript, Seeking
`Alpha, February 18, 2014
`Shire, Q3 2015 Results,
`October 23, 2015
`
`2105
`
`2106
`
`2107
`
`Shire, Q3 2015 Results,
`October 23, 2015
`
`Original Document Requirement; Fed. R.
`Evid. 1002
`
`Hearsay; Fed. R. Evid. 802
`Unauthenticated; Fed. R. Evid. 901
`Original Document Requirement; Fed. R.
`Evid. 1002
`
`Hearsay; Fed. R. Evid. 802
`Unauthenticated; Fed. R. Evid. 901
`Original Document Requirement; Fed. R.
`Evid. 1002
`Hearsay; Fed. R. Evid. 802
`Unauthenticated; Fed. R. Evid. 901
`Original Document Requirement; Fed. R.
`Evid. 1002
`2108 Wolters Kluwer Price Data Hearsay; Fed. R. Evid. 802
`Unauthenticated; Fed. R. Evid. 901
`Original Document Requirement; Fed. R.
`Evid. 1002
`Hearsay; Fed. R. Evid. 802
`Unauthenticated; Fed. R. Evid. 901
`Original Document Requirement; Fed. R.
`Evid. 1002
`
`
`2109
`
`2110
`
`2111
`
`2112
`
`
`
`NPS Pharmaceuticals'
`(NPSP) CEO Francois
`Nader on Q1 2014 Results
`Earnings
`Call Transcript, Seeking
`Alpha, May 8, 2014
`NPS Pharmaceuticals'
`(NPSP) CEO Francois
`Nader on Q2 2014 Results
`Earnings
`Call Transcript, Seeking
`Alpha, August 06, 2014
`PS Pharmaceuticals'
`(NPSP) CEO Francois
`Nader on Q3 2014 Results
`Earnings
`Call Transcript, Seeking
`Alpha, November 10, 2014
`NPS Pharmaceuticals, Inc. Unauthenticated; Fed. R. Evid. 901
`
`Hearsay; Fed. R. Evid. 802
`Unauthenticated; Fed. R. Evid. 901
`Original Document Requirement; Fed. R.
`Evid. 1002
`
`
`Hearsay; Fed. R. Evid. 802
`Unauthenticated; Fed. R. Evid. 901
`Original Document Requirement; Fed. R.
`Evid. 1002
`
`
`9
`
`
`
`Form 10K for the fiscal
`year ended December 31,
`2014
`Shire, Q1 2015 Results,
`April 30, 2015
`
`2113
`
`2114
`
`Shire, Q2 2015 Results,
`July 23, 2015
`
`Shire Plc (SHPG)
`Flemming Ornskov on Q3
`2015 Results -
`Earnings Call Transcript,
`Oct. 23, 2015
`NPS Pharmaceuticals' CEO
`Discusses FDA Approval
`and
`Commercial launch of
`Gattex (Transcript), Jan. 2,
`2013
`Yahoo Finance, NPSP
`Historical Prices,
`http://finance.yahoo.com/q/
`hp?s=NPSP&a=00&b=1&c
`=2010&d=00&e=18&f=20
`16&g=d
`NPS Pharmaceuticals, Inc.
`Form 10K for the fiscal
`year ended December 31,
`2013
`Angela Moon, Reuters,
`Biotech Selloff Could be
`Harbinger of Further
`Decline, March 21, 2014
`Biotech Sell Off Drags
`NASDAQ-100 Down To 2-
`Year Lows,
`
`2115
`
`2116
`
`2117
`
`2118
`
`2119
`
`2120
`
`
`
`Hearsay; Fed. R. Evid. 802
`Unauthenticated; Fed. R. Evid. 901
`Original Document Requirement; Fed. R.
`Evid. 1002
`Hearsay; Fed. R. Evid. 802
`Unauthenticated; Fed. R. Evid. 901
`Original Document Requirement; Fed. R.
`Evid. 1002
`Hearsay; Fed. R. Evid. 802
`Unauthenticated; Fed. R. Evid. 901
`Original Document Requirement; Fed. R.
`Evid. 1002
`Incomplete; Fed. R. Evid. 106
`Hearsay; Fed. R. Evid. 802
`Unauthenticated; Fed. R. Evid. 901
`Original Document Requirement; Fed. R.
`Evid. 1002
`Incomplete; Fed. R. Evid. 106
`
`Hearsay; Fed. R. Evid. 802
`Unauthenticated; Fed. R. Evid. 901
`Best Evidence Rule; Fed. R. Evid. 1001
`
`
`Unauthenticated; Fed. R. Evid. 901
`
`Hearsay; Fed. R. Evid. 802
`
`
`Hearsay; Fed. R. Evid. 802
`Unauthenticated; Fed. R. Evid. 901
`
`
`10
`
`
`
`http://www.bidnessetc.com/
`21468-news-analysis-
`biotech-sell-off-drags-
`nasdaq-100-down-to-2-
`year-lows/
`NASDAQ Overview for
`NBI,https://indexes.nasdaq
`omx.com/Index/Overview/
`NBI
`Yahoo Finance, NBI
`Historical Prices,
`http://finance.yahoo.com/q/
`hp?s=^NBI&a=00&b=1&c
`=2010&d=11&e=31&f=20
`15&g=d&z=66&y=0
`Yahoo Finance, XBI
`Historical Prices,
`http://finance.yahoo.com/q/
`hp?s=XBI&a=00&b=1&c=
`2010&d=11&e=31&f=2015
`&g=d
`Gattex, Patient Assistance
`Program
`TD Ameritrade, NPS
`Pharmaceuticals (NPSP)
`$32.25 down $0.35...,
`6/3/14
`Randy Osborne, Natpara
`sails through panel despite
`headwind; NPS
`Pharma gets an 85
`'yes' vote in
`Hypoparathyroidism,
`http://www.bioworld.com/c
`ontent/natparasailsthroughp
`aneldespiteheadwindnpspha
`rmagets85yesvotehypoparat
`hyroidism
`Shire plc Form 10-Q filed
`
`2121
`
`2122
`
`2123
`
`2124
`
`2125
`
`2126
`
`2127
`
`
`
`Hearsay; Fed. R. Evid. 802
`Unauthenticated; Fed. R. Evid. 901
`
`
`Hearsay; Fed. R. Evid. 802
`Unauthenticated; Fed. R. Evid. 901
`Best Evidence Rule; Fed. R. Evid. 1001
`
`
`Hearsay; Fed. R. Evid. 802
`Unauthenticated; Fed. R. Evid. 901
`Best Evidence Rule; Fed. R. Evid. 1001
`
`
`Hearsay; Fed. R. Evid. 802
`Unauthenticated; Fed. R. Evid. 901
`Hearsay; Fed. R. Evid. 802
`Unauthenticated; Fed. R. Evid. 901
`
`Hearsay; Fed. R. Evid. 802
`
`Hearsay; Fed. R. Evid. 802
`
`11
`
`
`
`Unauthenticated; Fed. R. Evid. 901
`Original Document Requirement; Fed. R.
`Evid. 1002
`Hearsay; Fed. R. Evid. 802
`Unauthenticated; Fed. R. Evid. 901
`
`
`Hearsay; Fed. R. Evid. 802
`Unauthenticated; Fed. R. Evid. 901
`Incomplete; Fed. R. Evid. 106
`
`
`
`Hearsay; Fed. R. Evid. 802
`
`
`Hearsay; Fed. R. Evid. 802
`Unauthenticated; Fed. R. Evid. 901
`Original Document Requirement; Fed. R.
`Evid. 1002
`Hearsay; Fed. R. Evid. 802
`Unauthenticated; Fed. R. Evid. 901
`Original Document Requirement; Fed. R.
`Evid. 1002
`Incomplete; Fed. R. Evid. 106
`Hearsay; Fed. R. Evid. 802
`Incomplete; Fed. R. Evid. 106
`
`Relevancy; Fed. R. Evid. 401, 402, and 403
`Hearsay; Fed. R. Evid. 802
`
`12
`
`May 05, 2015
`
`2128
`
`U.S. Food and Drug
`Administration, Expiration
`Dating and Stability Testing
`for
`Human Drug Products,
`http://www.fda.gov/ICECI/
`Inspections/InspectionGuid
`es/InspectionTechnicalGuid
`es/ucm072919.htm
`2129 Mark Gibson (ed.),
`Pharmaceutical
`Preformulation and
`Formulation, Second
`Edition, Volume 199, 2009,
`p. 181
`Laurie P. Cohen, Many
`Medicines Are Potent Years
`After Expiration Dates,
`Wall Street Journal,
`http://www.mercola.com/20
`00/apr/2/drug_expiration.ht
`m
`2131 Merck KGaA Annual
`Report 2014
`
`2130
`
`Center for Drug Evaluation
`and Research, Application
`Number:203441Orig1s000,
`Chemistry Review(s)
`
`Inside the Secret World of
`Drug Company Rebates,
`Forbes
`Gattex, Learn About Sharps
`Disposal
`
`2132
`
`2133
`
`2134
`
`
`
`
`
`2135
`
`Shire Patient Services:
`OnePath Support Program
`
`2136
`
`2137
`
`2138
`
`2139
`
`Patient Support Programs,
`Klick Health
`U.S. Food and Drug
`Administration, Design
`Considerations for Devices
`Intended for Home Use -
`Guidance for Industry and
`Food and Drug
`Administration Staff,
`November 24, 2014
`Label and Approval
`History, Gattex Kit
`Adempas (riociguat) Aim
`Patient Support Program
`Overview,
`http://www.adempas-us.
`com/support-every-step-of-
`the-way/
`Celgene Patient Support,
`https://www.celgenepatient
`support.com/
`
`Unauthenticated; Fed. R. Evid. 901
`Relevancy; Fed. R. Evid. 401, 402, and 403
`Hearsay; Fed. R. Evid. 802
`Unauthenticated; Fed. R. Evid. 901
`Incomplete; Fed. R. Evid. 106
`Hearsay; Fed. R. Evid. 802
`Unauthenticated; Fed. R. Evid. 901
`Relevancy; Fed. R. Evid. 401, 402, and 403
`Hearsay; Fed. R. Evid. 802
`Unauthenticated; Fed. R. Evid. 901
`Original Document Requirement; Fed. R.
`Evid. 1002
`
`Relevancy; Fed. R. Evid. 401, 402, and 403
`Unauthenticated; Fed. R. Evid. 901
`Relevancy; Fed. R. Evid. 401, 402, and 403
`Hearsay; Fed. R. Evid. 802
`Unauthenticated; Fed. R. Evid. 901
`
`2140
`
`Relevancy; Fed. R. Evid. 401, 402, and 403
`Hearsay; Fed. R. Evid. 802
`Unauthenticated; Fed. R. Evid. 901
`Incomplete; Fed. R. Evid. 106
`2141 Merck Annual Report 2006 Hearsay; Fed. R. Evid. 802
`Unauthenticated; Fed. R. Evid. 901
`Original Document Requirement; Fed. R.
`Evid. 1002
`2142 Merck Annual Report 2007 Hearsay; Fed. R. Evid. 802
`Unauthenticated; Fed. R. Evid. 901
`Original Document Requirement; Fed. R.
`Evid. 1002
`2143 Merck Annual Report 2008 Hearsay; Fed. R. Evid. 802
`Unauthenticated; Fed. R. Evid. 901
`Original Document Requirement; Fed. R.
`Evid. 1002
`
`
`
`13
`
`
`
`2144 Merck Annual Report 2009 Hearsay; Fed. R. Evid. 802
`Unauthenticated; Fed. R. Evid. 901
`Original Document Requirement; Fed. R.
`Evid. 1002
`2145 Merck Annual Report 2010 Hearsay; Fed. R. Evid. 802
`Unauthenticated; Fed. R. Evid. 901
`Original Document Requirement; Fed. R.
`Evid. 1002
`2146 Merck Annual Report 2011 Hearsay; Fed. R. Evid. 802
`Unauthenticated; Fed. R. Evid. 901
`Original Document Requirement; Fed. R.
`Evid. 1002
`2147 Merck Annual Report 2012 Hearsay; Fed. R. Evid. 802
`Unauthenticated; Fed. R. Evid. 901
`Original Document Requirement; Fed. R.
`Evid. 1002
`Relevancy; Fed. R. Evid. 401, 402 and 403
`Hearsay; Fed. R. Evid. 802
`Improper expert testimony; Fed. R. Evid.
`702, 703
`Original Document Requirement; Fed. R.
`Evid. 1002
`Relevancy; Fed. R. Evid. 401, 402 and 403
`Hearsay; Fed. R. Evid. 802
`Improper expert testimony; Fed. R. Evid.
`702, 703
`Original Document Requirement; Fed. R.
`Evid. 1002
`
`2149
`
`Declaration of Gordon
`Rausser, Ph.D. (redacted)
`
`2148
`
`Declaration of John F.
`Carpenter, Ph.D. (redacted)
`
`
`
`
`
`14
`
`
`
`
`
`
`
`Respectfully submitted,
`
`MERCHANT & GOULD P.C.
`
`
`
`
`/s/ Matthew L. Fedowitz
`Jeffrey D. Blake, Reg. No. 58,884
`Matthew L. Fedowitz, Reg. No. 61,386
`Brent E. Routman (pro hac pending)
`Merchant & Gould P.C.
`191 Peachtree Street N.E., Suite 4300
`Atlanta, GA 30303
`Attorneys for Petitioner
`
`15
`
`Date: January 27, 2016
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`CERTIFICATE OF SERVICE ON PATENT OWNER
`
`Pursuant to 37 C.F.R. § 42.6(e), the undersigned certifies that on the 27th
`
`day of January, 2016, a complete and entire copy of PETITIONER’S
`
`OBJECTIONS TO PATENT OWNER’S EXHIBITS SUBMITTED WITH ITS
`
`PATENT OWNER’S RESPONSE were provided via electronic mail to the
`
`following counsel as designated in Patent Owner’s Mandatory Notices (Paper
`
`5):
`
`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
`
`
`
`
`
`
`Respectfully submitted,
`MERCHANT & GOULD P.C.
`
`BY: /s/ Matthew L. Fedowitz
` Matthew L. Fedowitz
` Merchant & Gould P.C.
` 1701 Duke Street, Suite 310
` Alexandria, VA 22314
`
`16
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