`
`PETITIONER’S DEMONSTRATIVES
`
` July 21, 2016
`Oral Argument
`
`
`Coalition for Affordable Drugs VI LLC,
`Petitioner
`
`v.
`
`Celgene Corporation,
` Patent Owner
`
`
`
`IPR2015-01092, -01096, -01102, -01103
`
`
`
`
`
`
`
`CFAD DX - 88
`
`
`
`
`
`U.S. PATENT No. 6,315,720
`GROUNDS FOR
`INSTITUTION OF IPR
`
`CFAD DX - 89
`
`
`
`Grounds for Institution of IPR
`Institution Decision – IPR2015-01096
`
`Source: Paper 21 (-01096), Institution Decision, at 23.
`
`CFAD DX - 90
`
`
`
`Grounds for Institution of IPR
`Institution Decision – IPR2015-01102
`
`Source: Paper 21 (-01102), Institution Decision, at 25.
`
`CFAD DX - 91
`
`
`
`Grounds for Institution of IPR
`Institution Decision – IPR2015-01103
`
`Source: Paper 22 (-01103), Institution Decision, at 25.
`
`CFAD DX - 92
`
`
`
`
`
`BURDEN OF PROOF
`BURDEN OF PROOF
`
`
`
`CFAD DX - 93
`
`
`
`BURDEN OF PROOF
`
`In an inter partes review instituted under this
`chapter, the petitioner shall have the burden of
`proving a proposition of unpatentability by a
`preponderance of the evidence.
` 35 U.S.C. § 316(e)
`
`Source: 35 U.S.C. § 316(e)
`
`CFAD DX - 94
`
`
`
`
`
`’720 Patent –
`a aA oe: ba00) ee
`Claims
`Claims
`
`
`CFAD DX - 95
`
`
`
`’720 Patent — Claim 1
`
`
`prior art: ’501 patent
`
`defining patient risk groups
`
`defining probative information
`
`risk group assignment
`
`determining acceptability of risk
`
`generating prescription approval code
`
`Source: Ex. 1001 at claims.
`
`CFAD DX - 96
`
`
`
`’720 Patent — Claim 28
`
`Identical to claim 1, with this
`addition:
`
`Source: Ex. 1001 at claims.
`
`CFAD DX - 97
`
`
`
`’720 Patent — Dependent Claims
`
`
`Patent Owner makes additional arguments for only claims 5, 10, and 17.
`
`
`Source: Ex. 1001 at claims.
`
`CFAD DX - 98
`
`
`
`
`
`PERSON OF ORDINARY
`PERSON OF ORDINARY
`SKILL IN THE ART
`SKILL IN THE ART
`
`CFAD DX - 99
`
`
`
`POSA
`
`The Institution Decision
`
`Source: Paper 21 (-01096), Institution Decision, at 8.
`
`CFAD DX - 100
`
`
`
`POSA
`
`Dr. Frau Offers the Same Definitions as
`for the ’501 Patent
`
`Standard:
`
`Source: Ex. 1075 (-01096) at 306:4-21.
`
`CFAD DX - 101
`
`
`
`
`
`CLAIM CONSTRUCTION
`CLAIM CONSTRUCTION
`
`CFAD DX - 102
`
`
`
`CLAIM CONSTRUCTION
`
`
`Standard:
`“…broadest reasonable interpretation in light of the specification.”
`
`
`
`Claim term in dispute:
`
`
`Petitioner:
`No construction necessary.
`
`“prescription approval code”
`
`Patent Owner:
`“code representing that an
`affirmative risk assessment has
`been made based upon
`risk-group assignment and the
`information collected from the
`patient, and that is
`generated only upon a
`determination that the risk of a
`side effect occurring is
`acceptable.”
`
`Source: 37 C.F.R. § 42.100(b); Paper 52 (-01096), Petitioner’s Reply, at 9.
`
`CFAD DX - 103
`
`
`
`CLAIM CONSTRUCTION
`
`
`Source: Ex. 1001 (-01096) at 13:42–54.
`
`CFAD DX - 104
`
`
`
`CLAIM CONSTRUCTION
`
`
`Dr. Frau’s Admissions
`
`Dr. DiPiro’s Admissions
`
`Source: Ex. 1075 (-01096) at 316:9-17, Ex. 1074 (-01096) at 246:15-247:1.
`
`CFAD DX - 105
`
`
`
`CLAIM CONSTRUCTION
`
`Dr. Frau’s Misapplication of the
`Standard
`
`Source: Ex. 1075 (-01096) at 204:10-18.
`
`CFAD DX - 106
`
`
`
`CLAIM CONSTRUCTION
`
`Dr. Frau’s Misapplication of the
`Standard
`
`Source: Ex. 1075 (-01096) at 203:21-204:9.
`
`CFAD DX - 107
`
`
`
`CLAIM CONSTRUCTION
`
`The Prosecution History
`
`Source: Ex. 1002 (-01096) at 107.
`
`CFAD DX - 108
`
`
`
`
`
`PRIOR ART
`PRIOR ART
`
`
`CFAD DX - 109
`
`
`
`PRIOR ART
`
`Thalomid Package Insert
`
`Source: Paper 1 (-01096), Petition, at 15, 20-21, 39, 41-42, 46; Ex. 1006 (-01096) at 1.
`
`CFAD DX - 110
`
`
`
`PRIOR ART
`
`Thalomid Package Insert
`
`Source: Paper 1 (-01096), Petition, at 16, 29-30, 36, 47-48, 52, ; Ex. 1006 (-01096) at 2.
`
`CFAD DX - 111
`
`
`
`PRIOR ART
`
`Thalomid Package Insert
`
`Source: Paper 1 (-01096), Petition, at 26, 33, 35, 41-42, 49, 57; Ex. 1006 (-01096) at 2.
`
`CFAD DX - 112
`
`
`
`PRIOR ART
`
`Thalomid Package Insert
`
`Source: Paper 1 (-01096), Petition, at 42-43, 50; Ex. 1006 (-01096) at 3.
`
`CFAD DX - 113
`
`
`
`PRIOR ART
`
`Thalomid Package Insert
`
`Source: Paper 1 (-01096), Petition, at 16, 37, 39-40, 44 ; Ex. 1006 (-01096) at 4.
`
`CFAD DX - 114
`
`
`
`PRIOR ART
`
`Thalomid Package Insert
`
`Source: Paper 1 (-01096), Petition, at 44-45, 49; Ex. 1006 (-01096) at 6.
`
`CFAD DX - 115
`
`
`
`PRIOR ART
`
`Thalomid Package Insert
`
`Source: Paper 1 (-01096), Petition, at 48; Ex. 1006 (-01096) at 8.
`
`CFAD DX - 116
`
`
`
`PRIOR ART
`
`Thalomid Package Insert
`
`Source: Paper 1 (-01096), Petition, at 41; Ex. 1006 (-01096) at 9.
`
`CFAD DX - 117
`
`
`
`PRIOR ART
`
`Thalomid Package Insert
`
`Source: Paper 1 (-01096), Petition, at 29, 43-45, 49; Ex. 1006 (-01096) at 9.
`
`CFAD DX - 118
`
`
`
`PRIOR ART
`
`Thalomid Package Insert
`
`Source: Paper 1 (-01096), Petition, at 26, 42-43, 45, 51; Ex. 1006 (-01096) at 10.
`
`CFAD DX - 119
`
`
`
`PRIOR ART
`
`Thalomid Package Insert
`
`Source: Paper 1 (-01096), Petition, at 29, 44-45, 48-49, 51; Ex. 1006 (-01096) at 11.
`
`CFAD DX - 120
`
`
`
`PRIOR ART
`
`Thalomid Package Insert
`
`Source: Paper 1 (-01096), Petition, at 35, 50-51; Ex. 1006 (-01096) at 12.
`
`CFAD DX - 121
`
`
`
`PRIOR ART
`
`Thalomid Package Insert
`
`Source: Paper 1 (-01096), Petition, at 41; Ex. 1006 (-01096) at 13.
`
`CFAD DX - 122
`
`
`
`PRIOR ART
`
`Thalomid Package Insert
`
`Source: Paper 1 (-01096), Petition, at 21, 24, 31, 37, 47, 49; Ex. 1006 (-01096) at 18.
`
`CFAD DX - 123
`
`
`
`PRIOR ART
`
`Thalomid Package Insert
`
`Source: Paper 1 (-01096), Petition, at 34, 37, 41-42, 49; Ex. 1006 (-01096) at 19.
`
`CFAD DX - 124
`
`
`
`PRIOR ART
`
`Thalomid Package Insert
`
`Source: Paper 1 (-01096), Petition, at 26, 31-35, 38, 43-50; Ex. 1006 (-01096) at 20.
`
`CFAD DX - 125
`
`
`
`PRIOR ART
`
`Thalomid Package Insert
`
`Source: Paper 1 (-01096), Petition, at 29, 44-45, 49; Ex. 1006 (-01096) at 21.
`
`CFAD DX - 126
`
`
`
`PRIOR ART
`
`S.T.E.P.S. Materials
`
`Source: Ex. 2065 (-01096); Paper 52 (-01096), Reply, at 23-24.
`
`CFAD DX - 127
`
`
`
`PRIOR ART
`
`S.T.E.P.S. Materials
`
`Source: Ex. 2064 (-01096); Paper 52 (-01096), Reply, at 23-24.
`
`CFAD DX - 128
`
`
`
`Keravich
`
`PRIOR ART
`
`
`Source: Ex. 1018 (-01096); Paper 52 (-01096), Reply, at 23-24.
`
`CFAD DX - 129
`
`
`
`PRIOR ART
`
`The Institution Decision - 01096
`
`Source: Paper 21 (-01096), Institution Decision, at 17.
`
`CFAD DX - 130
`
`
`
`PRIOR ART
`
`The Institution Decision - 01096
`
`Source: Paper 21 (-01096), Institution Decision, at 18.
`
`CFAD DX - 131
`
`
`
`PRIOR ART
`
`The Institution Decision - 01096
`
`Source: Paper 21 (-01096), Institution Decision, at 20.
`
`CFAD DX - 132
`
`
`
`Mitchell
`
`PRIOR ART
`
`
`Source: Paper 1 (-01103), Petition, at 53-55; Ex. 1010 (-01103) at 101.
`
`CFAD DX - 133
`
`
`
`Mitchell
`
`PRIOR ART
`
`
`Source: Paper 1 (-01103), Petition, at 52, 57-58; Ex. 1010 (-01103) at 101.
`
`CFAD DX - 134
`
`
`
`Mitchell
`
`PRIOR ART
`
`
`Source: Paper 1 (-01103), Petition, at 26, 46, 49-50, 54-55, 58-59; Ex. 1010 (-01103) at 101.
`
`CFAD DX - 135
`
`
`
`Mitchell
`
`PRIOR ART
`
`
`Source: Paper 1 (-01103), Petition, at 26, 37, 47-48, 53, 56; Ex. 1010 (-01103) at 102.
`
`CFAD DX - 136
`
`
`
`Mitchell
`
`PRIOR ART
`
`
`Source: Paper 1 (-01103), Petition, at 20, 26-27, 34-36, 39, 50-51; Ex. 1010 (-01103) at 102.
`
`CFAD DX - 137
`
`
`
`Mitchell
`
`PRIOR ART
`
`
`Source: Paper 1 (-01103), Petition, at 39, 51, 58-59; Ex. 1010 (-01103) at 102.
`
`CFAD DX - 138
`
`
`
`Mitchell
`
`PRIOR ART
`
`
`Source: Paper 1 (-01103), Petition, at 15, 29, 34, 37, 39, 40, 42, 51, 55, 58, 59; Ex. 1010 (-01103) at 103.
`
`CFAD DX - 139
`
`
`
`Mitchell
`
`PRIOR ART
`
`
`Source: Paper 1 (-01103), Petition, at 38, 52, 55, 57-58; Ex. 1010 (-01103) at 104.
`
`CFAD DX - 140
`
`
`
`Mitchell
`
`PRIOR ART
`
`
`Source: Paper 1 (-01103), Petition, at 12, 14, 19, 20, 26, 47-49, 50, 57; Ex. 1010 (-01103) at 105.
`
`CFAD DX - 141
`
`
`
`PRIOR ART
`
`Institution Decision - 01103
`
`Source: Paper 22 (-01103), Institution Decision, at 18-19.
`
`CFAD DX - 142
`
`
`
`Powell
`
`PRIOR ART
`
`
`Source: Paper 1 (-01102), Petition, at 32, 44-47, 52, 56-58; Ex. 1006 (-01102) at 901.
`
`CFAD DX - 143
`
`
`
`Powell
`
`PRIOR ART
`
`
`Source: Paper 1 (-01102), Petition, at 26, 28, 33, 36, 38-39, 41, 46-47, 49, 50-52, 55-59; Ex. 1006 (-01102) at 901.
`
`CFAD DX - 144
`
`
`
`Powell
`
`PRIOR ART
`
`
`Source: Paper 1 (-01102), Petition, at 28, 34, 36, 41, 51, 53-55, 59; Ex. 1006 (-01102) at 902.
`
`CFAD DX - 145
`
`
`
`Powell
`
`PRIOR ART
`
`
`Source: Paper 1 (-01102), Petition, at 14-15, 25, 48-49; Ex. 1006 (-01102) at 902.
`
`CFAD DX - 146
`
`
`
`Powell
`
`PRIOR ART
`
`
`Source: Paper 1 (-01102), Petition, at 34, 48-50, 53-54; Ex. 1006 (-01102) at 903.
`
`CFAD DX - 147
`
`
`
`Powell
`
`PRIOR ART
`
`
`Source: Paper 1 (-01102), Petition, at 15, 25-26, 33, 49-50, 53, 56, 59; Ex. 1006 (-01102) at 903.
`
`CFAD DX - 148
`
`
`
`Powell
`
`PRIOR ART
`
`
`Source: Paper 1 (-01102), Petition, at 20, 46; Ex. 1006 (-01102) at 904.
`
`CFAD DX - 149
`
`
`
`PRIOR ART
`
`Institution Decision - 01102
`
`Source: Paper 21 (-01102), Institution Decision, at 18.
`
`CFAD DX - 150
`
`
`
`PRIOR ART
`
`Institution Decision - 01102
`
`Source: Paper 21 (-01102), Institution Decision, at 21-22.
`
`CFAD DX - 151
`
`
`
`Dishman
`
`PRIOR ART
`
`
`Source: Paper 1 (-01102), Petition, at 13, 16, 34, 38-39, 45-47, 53-54, 56, 58; Ex. 1007 (-01102) at 899.
`
`CFAD DX - 152
`
`
`
`Dishman
`
`PRIOR ART
`
`
`Source: Paper 1 (-01102), Petition, at 15-16, 21-22, 28, 35-36, 41, 45, 47, 51, 54, 59; Ex. 1007 (-01102) at 900.
`
`CFAD DX - 153
`
`
`
`Dishman
`
`PRIOR ART
`
`
`Source: Paper 1 (-01102), Petition, at 15-16, 26-28, 35-36, 38, 41, 43, 54, 58-60; Ex. 1007 (-01102) at 900.
`
`CFAD DX - 154
`
`
`
`Dishman
`
`PRIOR ART
`
`
`Source: Paper 1 (-01102), Petition, at 26-27, 36, 47, 50, 53-55; Ex. 1007 (-01102) at 900.
`
`CFAD DX - 155
`
`
`
`Dishman
`
`PRIOR ART
`
`
`Source: Paper 1 (-01102), Petition, at 27, 50, 54-55; Ex. 1007 (-01102) at 901.
`
`CFAD DX - 156
`
`
`
`PRIOR ART
`
`Institution Decision – 01102 (and – 01103)
`
`Source: Paper 21 (-01102), Institution Decision, at 19; Paper 22 (-01103), Institution Decision, at 20.
`
`CFAD DX - 157
`
`
`
`Cunningham
`
`PRIOR ART
`
`
`Source: Paper 1 (-01096), Petition, at 53, 59-60; Ex. 1009 (-01096) at 11:6-23.
`
`CFAD DX - 158
`
`
`
`Cunningham
`
`PRIOR ART
`
`
`Source: Paper 1 (-01096), Petition, at 53, 59-60; Ex. 1009 (-01096) at 10:28-38.
`
`CFAD DX - 159
`
`
`
`PRIOR ART
`
`Institution Decision – 01096 (- 1102, - 1103)
`
`Source: Paper 21 (-01096), Institution Decision, at 19; Paper 21 (-01102), Institution Decision, at 19-20; Paper 22 (-01103), Institution Decision, at 20.
`
`CFAD DX - 160
`
`
`
`PRIOR ART
`
`Institution Decision – 01096 (- 1102, - 1103)
`
`Source: Paper 21 (-01096), Institution Decision, at 19; Paper 21 (-01102), Institution Decision, at 19-20; Paper 22 (-01103), Institution Decision, at 20.
`
`CFAD DX - 161
`
`
`
`PRIOR ART
`
`Dr. Frau’s Admissions
`
`Source: Ex. 1075 (-01096) at 319:15-20.
`
`CFAD DX - 162
`
`
`
`PRIOR ART
`
`Dr. DiPiro’s Admissions
`
`2
`
`Source: Ex. 1074 (-01096) at 268:3-18.
`
`CFAD DX - 163
`
`
`
`Mundt
`
`PRIOR ART
`
`
`Source: Paper 1 (-01096), Petition, at 59; Ex. 1024 (-01096) at 611.
`
`CFAD DX - 164
`
`
`
`Mundt
`
`PRIOR ART
`
`
`Source: Ex. 1024 (-01096) at 612; Paper 52 (-01096), Petitioner’s Reply, at 26-27.
`
`CFAD DX - 165
`
`
`
`PRIOR ART
`
`Dr. Fudin’s Testimony
`
`Source: Ex. 1021 (-01096) ¶ 233; Paper 52 (-01096), Petitioner’s Reply, at 27.
`
`CFAD DX - 166
`
`
`
`PRIOR ART
`
`Institution Decision – 01096 (- 1102, - 1103)
`
`
`Source: Paper 21 (-01096), Institution Decision, at 20; Paper 21 (-01102), Institution Decision, at 22; Paper 22 (-01103), Institution Decision, at 23.
`
`CFAD DX - 167
`
`
`
`PRIOR ART
`
`FDA Meeting - Genetics
`
`Source: Ex. 1013 (-01096) at 137; Paper 52 (-01096), Petitioner’s Reply, at 25.
`
`CFAD DX - 168
`
`
`
`PRIOR ART
`
`Dr. Fudin’s Testimony
`
`Source: Ex. 1021 (-01096) ¶ 141; Paper 52 (-01096), Petitioner’s Reply, at 25.
`
`CFAD DX - 169
`
`
`
`
`
`MOTIVATION TO COMBINE
`MOTIVATION TO COMBINE
`
`CFAD DX - 170
`
`
`
`MOTIVATION TO COMBINE
`
`Petition
`
`Source: Paper 1 (-01096), Petition, at 13.
`
`CFAD DX - 171
`
`
`
`MOTIVATION TO COMBINE
`
`Petition
`
`Source: Paper 1 (-01096), Petition, at 14.
`
`CFAD DX - 172
`
`
`
`MOTIVATION TO COMBINE
`
`Petition
`
`Source: Paper 1 (-01096), Petition, at 54.
`
`CFAD DX - 173
`
`
`
`MOTIVATION TO COMBINE
`
`Petition
`
`Source: Paper 1 (-01102), Petition, at 21.
`
`CFAD DX - 174
`
`
`
`MOTIVATION TO COMBINE
`
`Dr. Fudin’s Testimony (-01096)
`
`Source: Ex. 1002 (-01096) ¶¶ 52, 59.
`
`CFAD DX - 175
`
`
`
`MOTIVATION TO COMBINE
`
`Dr. Fudin’s Testimony (-01102)
`
`Source: Ex. 1027 (-01102) ¶¶ 59, 91.
`
`CFAD DX - 176
`
`
`
`MOTIVATION TO COMBINE
`
`Dr. Fudin’s Testimony (-01103)
`
`Source: Ex. 1027 (-01103) ¶ 60.
`
`CFAD DX - 177
`
`
`
`MOTIVATION TO COMBINE
`
`
`Zeldis
`
`Source: Ex. 1012 (-01096) at 329; Ex. 2061 (-01096) at 565:10-567:16.
`
`CFAD DX - 178
`
`
`
`MOTIVATION TO COMBINE
`
`FDA Meeting
`
`Source: Ex. 1013 (-01096) at 111.
`
`CFAD DX - 179
`
`
`
`MOTIVATION TO COMBINE
`
`FDA Meeting
`
`Source: Ex. 1013 (-01096) at 112.
`
`CFAD DX - 180
`
`
`
`MOTIVATION TO COMBINE
`
`Institution Decision – 01096 (- 1102, - 1103)
`
`Source: Paper 21 (-01096), Institution Decision, at 18; Paper 21 (-01102), Institution Decision, at 19; Paper 22 (-01103), Institution Decision, at 19.
`
`CFAD DX - 181
`
`
`
`MOTIVATION TO COMBINE
`
`Institution Decision – 01102 (and – 01103)
`
`Source: Paper 21 (-01102), Institution Decision, at 17; Paper 22 (-01103), Institution Decision, at 17-18.
`
`CFAD DX - 182
`
`
`
`MOTIVATION TO COMBINE
`
`Institution Decision – 01102 (and – 01103)
`
`Source: Paper 21 (-01102), Institution Decision, at 18; Paper 22 (-01103), Institution Decision, at 18.
`
`CFAD DX - 183
`
`
`
`MOTIVATION TO COMBINE
`
`Institution Decision - 01103
`
`Source: Paper 22 (-01103), Institution Decision, at 17.
`
`CFAD DX - 184
`
`
`
`MOTIVATION TO COMBINE
`
`Patent Owner’s Response
`
`Source: Paper 40 (-01096), Patent Owner Response, at 6.
`
`CFAD DX - 185
`
`
`
`MOTIVATION TO COMBINE
`
`
`Zeldis
`
`Source: Ex. 1012 (-01096) at 329.
`
`CFAD DX - 186
`
`
`
`MOTIVATION TO COMBINE
`
`FDA Meeting
`
`Source: Ex. 1013 (-01096) at 119.
`
`CFAD DX - 187
`
`
`
`MOTIVATION TO COMBINE
`
`Dr. DiPiro’s Admission
`
`Source: Ex. 1074 (-01096) at 326:20-327:5
`
`CFAD DX - 188
`
`
`
`MOTIVATION TO COMBINE
`
`Petitioner’s Reply
`
`Source: Paper 52 (-01096), Petitioner’s Reply, at 14-15; Paper 24 (-01102), Petitioner’s Reply, at 12; Paper 55 (-01103), Petitioner’s Reply, at 12.
`
`CFAD DX - 189
`
`
`
`MOTIVATION TO COMBINE
`
`Dr. Frau’s Admissions
`
`Source: Ex. 1075 (-01096) at 323:24-324:10; 324:18-325:13.
`
`CFAD DX - 190
`
`
`
`MOTIVATION TO COMBINE
`
`Dr. DiPiro’s Admissions
`
`Source: Ex. 1074 (-01096) at 216:22-217:8; 218:18-219:11.
`
`CFAD DX - 191
`
`
`
`MOTIVATION TO COMBINE
`
`Cunningham
`
`Source: Ex. 1009 (-01096) 2:44-59, 3:39-43.
`
`CFAD DX - 192
`
`
`
`MOTIVATION TO COMBINE
`
`Dr. DiPiro’s Admissions
`
`Source: Ex. 1074 (-01096) 268:3-18.
`
`CFAD DX - 193
`
`
`
`MOTIVATION TO COMBINE
`
`Dr. Frau’s Admissions
`
`Source: Ex. 1075 (-01096) at 320:8-21.
`
`CFAD DX - 194
`
`
`
`MOTIVATION TO COMBINE
`
`Bwire Publication
`
`Source: Ex. 1072 at 5.
`
`CFAD DX - 195
`
`
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