Filed on behalf of: Par Pharmaceutical, Inc. et al.
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`Entered: October 27, 2017
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_______________________
`
`PAR PHARMACEUTICAL, INC., ARGENTUM PHARMACEUTICAL LLC,
`AND WEST-WARD PHARMACEUTICALS INTERNATIONAL LIMITED,
`Petitioners
`v.
`NOVARTIS AG
`Patent Owner
`_______________________
`Case IPR2016-014791
`U.S. Patent No. 9,006,224
`_______________________
`
`Before LORA M. GREEN, CHRISTOPHER L. CRUMBLEY, and
`ROBERT A. POLLOCK, Administrative Patent Judges.
`
`
`
`
`
`PETITIONERS’ ORAL ARGUMENT DEMONSTRATIVES
`
`
`
`1 Argentum Pharmaceutical LLC was joined as a party to this proceeding via a
`Motion for Joinder in IPR2017-01063; West-Ward Pharmaceuticals International
`Limited was joined as a party via a Motion for Joinder in IPR2017-01078.
`
`
`
`
`
`
`
`
`
`
`Entered: October 27, 2017
`
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_______________________
`
`PAR PHARMACEUTICAL, INC., ARGENTUM PHARMACEUTICAL LLC,
`AND WEST-WARD PHARMACEUTICALS INTERNATIONAL LIMITED,
`Petitioners
`v.
`NOVARTIS AG
`Patent Owner
`_______________________
`Case IPR2016-014791
`U.S. Patent No. 9,006,224
`_______________________
`
`Before LORA M. GREEN, CHRISTOPHER L. CRUMBLEY, and
`ROBERT A. POLLOCK, Administrative Patent Judges.
`
`
`
`
`
`PETITIONERS’ ORAL ARGUMENT DEMONSTRATIVES
`
`
`
`1 Argentum Pharmaceutical LLC was joined as a party to this proceeding via a
`Motion for Joinder in IPR2017-01063; West-Ward Pharmaceuticals International
`Limited was joined as a party via a Motion for Joinder in IPR2017-01078.
`
`
`
`Petitioner’s Demonstratives
`
`Par Pharmaceuticals, Inc., Argentum
`Pharmaceutical LLC, and West-Ward
`Pharmaceuticals International Ltd.,
`Petitioners
`
`v.
`Novartis AG,
`Patent Owner
`
`IPR2016-01479, IPR2017-01063, IPR2017-01078
`U.S. Patent No. 9,006,224
`
`Oral Argument
`November 1, 2017
`
`1
`
`
`
`Petitioner’s Demonstratives
`
`’224 Patent Claims Methods of Using Everolimus to Treat PNETs
`
`1. A method for treating pancreatic neuroendocrine
`tumors comprising administering to a human subject in
`need thereof
`
`a therapeutically effective amount of [everolimus]
`
`as a monotherapy
`
`and wherein the tumors are advanced tumors
`
`after failure of cytotoxic chemotherapy.
`
`Ex. 1001; Pet. 12
`
`2
`
`
`
`Petitioner’s Demonstratives
`
`Claim Construction of ’224 Patent
`
`Inst. Dec. at 7
`
`Inst. Dec. 7
`
`3
`
`
`
`Petitioner’s Demonstratives
`
`’224 Patent Specification Examples
`
`Ex. 1001 at 25:54-26:10; Pet. 13; Ex. 1003 at ¶ 33
`
`Ex. 1001 at 25:54-26:10
`
`4
`
`
`
`Petitioner’s Demonstratives
`
`’224 Patent Specification Examples
`
`Ex. 1001 at 26:11-20
`
`Ex. 1001 at 25:54-26:10; Pet. 13; Ex. 1003 at ¶ 33
`
`5
`
`
`
`Petitioner’s Demonstratives
`
`’224 Patent Specification Examples
`
`*
`
`*
`
`*
`
`Ex. 1001 at 26:28-64; Pet. 13-14; Ex. 1003 at ¶¶ 35-37
`
`6
`
`Ex. 1001 at 26:28-64
`
`
`
`Petitioner’s Demonstratives
`
`Instituted Grounds
`
`Ground
`
`1
`
`2
`
`3
`
`4
`
`Oberg 2004
`
`Oberg 2004
`
`Combination
`Boulay 2004
`O’Donnell
`Boulay 2004
`O’Donnell
`Tabernero
`Boulay 2004
`O’Donnell
`Boulay 2004
`O’Donnell
`Tabernero
`
`Duran
`
`Duran
`
`Inst. Dec. 18
`
`7
`
`
`
`Petitioner’s Demonstratives
`
`Grounds 1 & 2: Oberg 2004 Combinations Render Claims Obvious
`
`Inst. Dec. at 11
`
`Inst. Dec. 11
`
`8
`
`
`
`Petitioner’s Demonstratives
`
`Grounds 1 & 2: Oberg Combinations Render the Claims Obvious
`
`“[W]hen a patent ‘simply arranges old elements with each
`performing the same function it had been known to perform’
`and yields no more than one would expect from such an
`arrangement, the combination is obvious.”
`
`KSR Int’l Co. v. Teleflex Inc.,
`550 U.S. 398, 417 (2007) (citations omitted)
`
`Pet. 39
`
`9
`
`
`
`Petitioner’s Demonstratives
`
`Ground 1: Oberg 2004 Discloses Claim 1 With Rapamycin
`
`A method for treating pancreatic neuroendocrine tumors
`comprising administering to a human subject in need
`thereof . . .
`
`Ex. 1027 at Fig. 1
`
`Pet. 29-32, 40-42; Ex. 1003 at ¶¶ 100-108, 133, 146
`
`10
`
`
`
`Petitioner’s Demonstratives
`
`Ground 1: Oberg 2004 Discloses Claim 1 With Rapamycin
`
`. . . a therapeutically effective amount of [everolimus] . . .
`
`Ex. 1027 at Fig. 1
`
`Pet. 29-32, 40-42; Ex. 1003 at ¶¶ 100-108, 133, 146
`
`11
`
`
`
`Petitioner’s Demonstratives
`
`Ground 1: Oberg 2004 Discloses Claim 1 With Rapamycin
`
`. . . as a monotherapy . . .
`
`Ex. 1027 at 60
`
`Ex. 1027 at F60
`
`Pet. 31, 41; Ex. 1003 at ¶¶ 104, 133
`
`12
`
`
`
`Petitioner’s Demonstratives
`
`Ground 1: Oberg 2004 Discloses Claim 1 With Rapamycin
`
`Ex. 1027 at Fig. 1
`. . .and wherein the tumors are advanced tumors . . .
`
`Pet. 29-32, 41; Ex. 1003 at ¶¶ 100-108, 133, 146
`
`Inst. Dec. at 7
`Inst. Dec. at 7
`
`13
`
`
`
`Petitioner’s Demonstratives
`
`Ground 1: Oberg 2004 Discloses Claim 1 With Rapamycin
`
`. . . after failure of cytotoxic chemotherapy.
`
`Ex. 1027 at Fig. 1
`
`Pet. 29-32, 41-42; Ex. 1003 at ¶¶ 100-108, 133, 146
`
`14
`
`
`
`Petitioner’s Demonstratives
`
`Ground 1: Rapamycin Is an “Interesting New Compound” with
`“Planned” Clinical Trials
`
`Ex. 1027 at 60
`
`Pet. 31, 42; Ex. 1003 at ¶¶ 104, 146
`
`15
`
`
`
`Petitioner’s Demonstratives
`
`Ground 1: Boulay 2004 and O’Donnell Teach Everolimus as
`Anticancer Agent
`Boulay 2004 (Ex. 1005) at 252
`“[Everolimus], an orally bioavailable derivative of rapamycin, . . .
`demonstrates potent antiproliferative effects against a variety of
`mammalian cell types. . . . As a result of these properties,
`[everolimus] is being clinically developed . . . as a novel
`therapeutic in the fight against human cancer.”
`
`O’Donnell (Ex. 1029) at 803
`“[Everolimus], a novel derivative of rapamycin, interacts with the
`mTOR protein . . . . [Everolimus] was well-tolerated with only mild
`degrees . . . of [side effects]. . . . At doses ≥20mg 7/8 patients
`exhibited inhibition for at least 7 days.”
`
`Pet. 32-35, 43-44; Ex. 1003 at ¶¶ 110, 120-21, 137-38
`
`16
`
`
`
`Petitioner’s Demonstratives
`
`Ground 1: Boulay 2004 Teaches Everolimus Activity in PNET Model
`Boulay 2004 (Ex. 1005) at 254, 258
`“[Everolimus] treatment . . . resulted in antitumor activity
`characterized by statistically significant inhibition of tumor growth
`as compared with vehicle controls.”
`
`“Moreover, all [everolimus] treatment schedules suppressed
`tumor growth to a similar extent as the cytotoxic 5-FU [positive
`control].”
`
`“For all treatment schedules, [everolimus] was well tolerated,
`with no significant body weight loss or mortalities observed.”
`
`“[T]he work presented here . . . demonstrat[es] significant
`antitumor efficacy of a rapamycin derivative in an animal model
`of pancreatic cancer.”
`
`Pet. 32-33, 43-44; Ex. 1003 at ¶¶ 111-16, 137
`
`17
`
`
`
`Petitioner’s Demonstratives
`
`Ground 1: CA20948 Cell Line Is a Preclinical Model for PNETs
`
`Pet. 32-33; Ex. 1003 at ¶ 112
`
`18
`
`Ex. 1010 at 356
`
`
`
`Petitioner’s Demonstratives
`
`Ground 1: CA20948 Cell Line Is a Preclinical Model for PNETs
`
`Animal of Origin
`Pancreas Cells
`Tumor of Origin
`Chemically Induced
`Somatostatin Receptor Positive
`Opinion of Dr. Kulke that Line is a NET model
`
`CA20948
`Rat
`Exocrine
`Acinar
`Azaserine
`Yes
`No
`
`Ex. 1089
`
`AR42J
`Rat
`Exocrine
`Acinar
`Azaserine
`Yes
`Yes
`
`Reply 17-18; Ex. 1119 at ¶ 44; Ex. 1053 at 15
`
`19
`
`
`
`Petitioner’s Demonstratives
`
`Ground 1: Oberg Combinations Render the Claims Obvious
`
`“But, it does not matter whether hair growth is generally an
`unpredictable endeavor—the question is more narrowly
`whether the success of using selective PGF analogs to treat
`hair loss would be reasonably unpredictable. . . . Once
`Johnstone was published, the general characteristics of the
`hair growth art ceased to be relevant. . . . Therefore, the
`correct question, at the time of the ′029 patent’s invention,
`was whether there was anything ‘unpredictable and
`mysterious’ about a PGF analog that could treat glaucoma
`growing hair.”
`
`Allergan Inc. v. Apotex Inc., 754 F.3d 952, 964 (Fed. Cir. 2014)
`
`Reply 14-15
`
`20
`
`
`
`Petitioner’s Demonstratives
`
`Ground 2: Tabernero Teaches 10 mg Dose of Everolimus
`
`Claim 2: The method of claim 1 wherein a unit dose of
`[everolimus] is 10 mg/day.
`
`Tabernero (Ex. 1038) at 3007
`“This phase I study shows that [everolimus], at the doses and
`schedules studied, results in intratumoral inhibition of mTOR
`signaling. Based on the toxicity profile and the MPD findings, a
`dosage of 10 mg daily can be recommended for further phase II-
`III development with [everolimus] as a single agent.”
`
`Pet. 35-36; Ex. 1003 at ¶¶ 125-127
`
`21
`
`
`
`Petitioner’s Demonstratives
`
`Grounds 3 & 4: Duran Combinations Render Claims Obvious
`
`Inst. Dec. 17
`
`Inst. Dec. 17
`
`22
`
`
`
`Petitioner’s Demonstratives
`
`Ground 3: Duran States mTOR Inhibition Is Reason for Use in NETs
`
`“Temsirolimus is a novel mTOR inhibitor that down regulates
`cascades activated by loss of the tumor suppressor protein
`PTEN, a defect reported in moderately differentiated NECs. Due
`to a lack of effective systemic therapy for NECs, loss of PTEN
`detected in some cases, and a report of a partial response in
`this tumor type from phase I trials, a multi-centre 2-stage phase
`II trial in NECs was conducted. “
`
`Ex. 1011 at 3096
`
`Pet. 36-37, 49-50; Ex. 1011; Ex. 1003 ¶¶ 129-131; Reply 16; Ex. 1119 ¶¶ 52, 60-64
`
`23
`
`
`
`Petitioner’s Demonstratives
`
`Ground 3: Duran Discloses Claim 1 With Temsirolimus
`
`“11 pts had prior chemotherapy.”
`
`“Among 15 pts evaluable for response thus far, 10 have achieved
`prolonged stable disease . . . , including 1 pt with a 24% tumor
`shrinkage . . . and 2 pts who have experienced significant clinical
`benefit . . . .”
`
`“Temsirolimus appears to have antitumor activity in NECs . . . .”
`
`Pet. 36-37, 49-50; Ex. 1011; Ex. 1003 ¶¶ 129-131; Reply 20-21; Ex. 1119 ¶¶ 69-70
`
`Ex. 1011 at 3096
`
`24
`
`
`
`Petitioner’s Demonstratives
`
`Ground 3: Boulay 2004 and O’Donnell Teach Everolimus as
`Anticancer Agent
`Boulay 2004 (Ex. 1005) at 252
`“[Everolimus], an orally bioavailable derivative of rapamycin, . . .
`Demonstrates potent antiproliferative effects against a variety of
`mammalian cell types. . . . As a result of these properties,
`[everolimus] is being clinically developed . . . as a novel
`therapeutic in the fight against human cancer.”
`
`O’Donnell (Ex. 1029) at 803
`“[Everolimus], a novel derivative of rapamycin, interacts with the
`mTOR protein . . . . [Everolimus] was well-tolerated with only
`mild degrees . . . of [side effects]. . . . At doses ≥20mg 7/8
`patients exhibited inhibition for at least 7 days.”
`
`Pet. 32-35, 49-50; Ex. 1003 at ¶¶ 110, 120-21, 141, 163-64, 167
`
`25
`
`
`
`Petitioner’s Demonstratives
`
`Ground 4: Tabernero Teaches 10 mg Dose of Everolimus
`
`Claim 2: The method of claim 1 wherein a unit dose of
`[everolimus] is 10 mg/day.
`
`Tabernero (Ex. 1038) at 3007
`“This phase I study shows that [everolimus], at the doses and
`schedules studied, results in intratumoral inhibition of mTOR
`signaling. Based on the toxicity profile and the MPD findings, a
`dosage of 10 mg daily can be recommended for further phase II-
`III development with [everolimus] as a single agent.”
`
`Pet. 53-54; Ex. 1003 at ¶¶ 143, 169, 176-77
`
`26
`
`
`
`Petitioner’s Demonstratives
`
`Novartis’s Responses Are Unfounded
`
`1. Dr. Ratain Qualifies at Least as a POSA
`
`2. The Prior Art and Novartis Consistently Refer to mTOR
`Inhibitors as a Drug Class
`
`3. The Prior Art and Dr. Kulke Identify the Same Treatments for
`Carcinoids and PNETs
`
`4. No Expected Difference in Response to Targeted Therapies
`After Failure of Chemotherapy
`
`Reply 2-13
`
`27
`
`
`
`Petitioner’s Demonstratives
`
`Dr. Ratain Qualifies as a POSA Under Dr. Kulke’s Definition
`
`Dr. Ratain
`Yes
`Yes
`Yes
`Yes
`
`Qualification
`M.D.
`Specific medical oncology experience
`Oncology drug development experience
`Clinical pharmacology experience
`Preclinical, clinical and/or laboratory research
`relating to NETs, including PNETs
`Yes
`Treated NETs
`Yes
`Enrolled NET patients on clinical trials
`Yes
`Published analysis of NET clinical trial data
`Ex. 2041 ¶¶ 21-22; Ex. 1070 51:8-18
`
`Yes
`
`Reply 2-3; Ex. 1119 ¶¶ 11-12; Ex. 2041 ¶¶ 21-22; Ex. 1070 51:8-18
`
`28
`
`
`
`Petitioner’s Demonstratives
`
`Novartis’s Responses Are Unfounded
`
`1. Dr. Ratain Qualifies at Least as a POSA
`
`2. The Prior Art and Novartis Consistently Refer to mTOR
`Inhibitors as a Drug Class
`
`3. The Prior Art and Dr. Kulke Identify the Same Treatments for
`Carcinoids and PNETs
`
`4. No Expected Difference in Response to Targeted Therapies
`After Failure of Chemotherapy
`
`Reply 2-13
`
`29
`
`
`
`Petitioner’s Demonstratives
`
`The Prior Art Groups mTOR Inhibitors as an Anticancer Drug Class
`
`“Agents that specifically inhibit
`mTOR are limited to rapamycin
`and the structurally related
`compounds [temsirolimus] and
`[everolimus].”
`
`“Rapamycins are [compounds]
`that possess immunosuppressive,
`antifungal and antitumor
`properties.”
`
`“Rapamycin and its analogues
`and its are a promising class of
`novel therapeutics that
`specifically inhibit . . . mTOR.”
`
`Ex. 1009 at 1104
`
`Ex. 1018 at 222
`
`Ex. 1033 at 621
`
`Pet. 22-28; Ex. 1003 ¶¶ 75-78, 86, 91; Ex. 1009; Ex. 1018; Ex. 1033; Ex. 1039; Reply 8-10; Ex. 1119 ¶ 58
`
`30
`
`
`
`Petitioner’s Demonstratives
`
`Novartis Groups mTOR Inhibitors as a Drug Class in the Prior Art
`
`Ex. 1123 at 1:50-55
`
`Reply 8-10; Ex. 1119 ¶ 58; Ex. 1123; Ex. 1124
`
`31
`
`
`
`Petitioner’s Demonstratives
`
`Novartis’s Responses Are Unfounded
`
`1. Dr. Ratain Qualifies at Least as a POSA
`
`2. The Prior Art and Novartis Consistently Refer to mTOR
`Inhibitors as a Drug Class
`
`3. The Prior Art and Dr. Kulke Identify the Same Treatments for
`Carcinoids and PNETs
`
`4. No Expected Difference in Response to Targeted Therapies
`After Failure of Chemotherapy
`
`Reply 2-13
`
`32
`
`
`
`Petitioner’s Demonstratives
`
`Dr. Kulke Admits Counsel Generated Organizational Chart
`
`Ex. 2041 ¶ 48
`
`Q. Did you generate this chart?
`A. What? As in PowerPoint?
`Q. Yeah.
`A. For this manuscript, no.
`Q. Was the chart presented to you by counsel?
`A. Yes.
`Ex. 1070 54:18-23
`33
`
`Reply 4, n.1
`
`
`
`Petitioner’s Demonstratives
`
`Novartis’s “Specific” Reference Shows Same Treatments For NETs
`
`Oberg 2004
`(Ex. 1027)
`
`Oberg & Eriksson
`(Ex. 1028)
`
`Journal
`
`Oncologia
`
`Best Practice &
`Research Clinical
`Gastroenterology
`
`Tumor Types
`
`NETs
`
`PNETs
`
`Reply 4-5, 7-9; Ex. 1119 ¶¶ 49-50
`
`34
`
`
`
`Petitioner’s Demonstratives
`
`Novartis’s “Specific” Reference Shows Same Treatments For NETs
`
`Journal
`
`Tumor Types
`Somatostatin Analogs
`Interferon
`Cytotoxic Chemotherapy
`Radiolabeled DOTA-
`Octreotide
`Rapamycin
`
`Oberg 2004
`(Ex. 1027)
`
`Oncologia
`
`NETs
`Yes
`Yes
`Yes
`
`Yes
`
`Yes
`
`Oberg & Eriksson
`(Ex. 1028)
`Best Practice &
`Research Clinical
`Gastroenterology
`PNETs
`Yes
`Yes
`Yes
`
`Yes
`
`No
`
`Clinical Data?
`
`Yes
`Yes
`Yes
`
`Yes
`
`No
`
`Reply 4-5, 7-9; Ex. 1119 ¶¶ 49-50
`
`35
`
`
`
`Petitioner’s Demonstratives
`
`Novartis’s “Specific” Reference Shows Same Treatments For NETs
`
`Oberg 2004
`(Ex. 1027)
`
`Oncologia
`
`Journal
`
`NETs
`Yes
`Yes
`Yes
`
`Yes
`
`Oberg & Eriksson
`(Ex. 1028)
`Best Practice &
`Research Clinical
`Gastroenterology
`PNETs
`Yes
`Yes
`Yes
`
`Yes
`
`Clinical Data?
`
`Yes
`Yes
`Yes
`
`Yes
`
`Tumor Types
`Somatostatin Analogs
`Interferon
`Cytotoxic Chemotherapy
`Radiolabeled DOTA-
`Octreotide
`No
`No
`Yes
`Rapamycin
`“[A] POSA would have considered the subsequent teaching
`in Oberg & Eriksson that relates specifically to PNETs to be
`more relevant to the problem facing them, i.e., the
`development of a new therapy . . . .”
`
`Reply 4-5, 7-9; Ex. 1119 ¶¶ 49-50
`
`Ex. 2041 ¶ 118
`36
`
`
`
`Petitioner’s Demonstratives
`
`Novartis’s Responses Are Unfounded
`
`1. Dr. Ratain Qualifies at Least as a POSA
`
`2. The Prior Art and Novartis Consistently Refer to mTOR
`Inhibitors as a Drug Class
`
`3. The Prior Art and Dr. Kulke Identify the Same Treatments for
`Carcinoids and PNETs
`
`4. No Expected Difference in Response to Targeted Therapies
`After Failure of Chemotherapy
`
`Reply 2-13
`
`37
`
`
`
`Petitioner’s Demonstratives
`
`Oberg 2004 Discloses Treatment After Failure of Chemotherapy
`
`Ex. 1027 at Fig. 1
`
`Pet. 40-42, 45
`
`38
`
`
`
`Petitioner’s Demonstratives
`
`Duran Discloses Treatment After Failure of Chemotherapy
`
`“11 pts had prior chemotherapy.”
`
`“Among 15 pts evaluable for response thus far, 10 have achieved
`prolonged stable disease . . . , including 1 pt with a 24% tumor
`shrinkage . . . and 2 pts who have experienced significant clinical
`benefit . . . .”
`
`“Temsirolimus appears to have antitumor activity in NECs . . . .”
`
`Pet. 36-37, 49-50
`
`Ex. 1011
`39
`
`
`
`Petitioner’s Demonstratives
`
`Dr. Kulke’s Prior Testimony On PNETs
`After Treatment With Chemotherapy
`
`Q. When a patient becomes refractory, what does that mean?
`
`A. So with . . . virtually any treatment now, you give a
`chemotherapy drug or a targeted agent to a patient with
`cancer, and that treatment may result in tumor shrinkage or
`may stop the cancer from growing. But over time, the cancer
`becomes resistant. Essentially, the cells figure out a way to
`get around the treatment. And, so, over time, the tumors
`will start to gradually grow. And then you have to look for
`another type of therapy.
`
`Reply 11
`
`Ex. 1095 at 798:11-21
`
`40
`
`
`
`Petitioner’s Demonstratives
`
`Prior Art Protocols For NETs After Treatment With Chemotherapy
`
`Clinical Study
`
`Therapy
`
`Duran (Ex. 1011)
`Carr (Ex. 2049)
`Shah (Ex. 1112)
`Hobday (Ex. 1090)
`Kulke (Ex. 2099)
`
`Temsirolimus
`Imatinib
`Bortezimib
`Gefitinib
`Sunitinib
`
`Allow Prior
`Chemotherapy?
`Yes
`Yes
`Yes
`Yes
`Yes
`
`Ex. 1119 ¶ 37
`
`Reply 11-12
`
`41
`
`
`
`Petitioner’s Demonstratives
`
`Novartis Fails to Establish Any Secondary Considerations
`
`1. RADIANT-3 Study Results Cannot Establish Unexpected Results
`
`2. No Long-Felt Unmet Need
`
`3. No Failure of Others
`
`Reply 22-25
`
`42
`
`
`
`Petitioner’s Demonstratives
`
`RADIANT-3 Study Results Cannot Establish Unexpected Results
`
`“[E]vidence of unexpected results must establish that there is a
`difference between the results obtained and those of the
`closest prior art.”
`Bristol-Myers Squibb CO. v. Teva Pharm. USA, Inc., 752 F.3d 967, 977 (Fed. Cir. 2014)
`
`1. No Evidence of a Difference Between
`Rapamycin/Temsirolimus and Everolimus in Treating PNETs
`2. No Difference Between Use of Everolimus as Monotherapy
`and in Combination with Somatostatin Analog
`3. No Difference Between Use of Everolimus in PNETs after
`Failure of Cytotoxic Chemotherapy and Chemotherapy-Naïve
`Tumors
`4. FDA-Approval Status Is Not a Property of Everolimus
`
`Reply 22-24; Ex. 1119 ¶¶ 73-89
`
`43
`
`
`
`Petitioner’s Demonstratives
`
`Temsirolimus Has Similar Activity to Everolimus in NETs
`
`Ex. 2028 at 1150
`
`Ex. 2108 at 32
`
`Reply 23; Ex. 1119 ¶¶ 74-80
`
`44
`
`
`
`Petitioner’s Demonstratives
`
`Dr. Kulke Told the FDA Temsirolimus Was a “Novel Therapy” for NET
`
`Reply 23; Ex. 1119 ¶ 80
`
`Ex. 1069 at 11
`
`45
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`CERTIFICATE OF SERVICE
`Pursuant to 37 C.F.R. § 42.6(e), I certify that on this 27th day of October,
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`2017, a true and correct copy of the foregoing PETITIONERS’ ORAL
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`ARGUMENT DEMONSTRATIVES was served by electronic mail on Patent
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`Owner’s lead and backup counsel at the following email address:
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`Nicholas N. Kallas (Reg. No. 31,530)
`Charlotte Jacobsen (pro hac vice)
`Fitzpatrick, Cella, Harper & Scinto
`1290 Avenue of the Americas
`New York, NY 10104-3800
`ZortressAfinitorIPR@fchs.com
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`Peter J. Waibel (Reg. No. 43,228)
`Gregory D. Ferraro (Reg. No. 36,134)
`NOVARTIS PHARMACEUTICALS CORPORATION
`One Health Plaza, Bldg. 430
`East Hanover, NJ 07936-1080
`Tel. 862-778-7838
`ZortressAfinitorIPR@fchs.com
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`By: /Daniel G. Brown/
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`Daniel G. Brown (Reg. No. 54,005)
`Latham & Watkins LLP
`885 Third Avenue
`New York, NY 10022-4834
`212-906-1200; 212-751-4864 (Fax)
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`Counsel for Petitioner
`Par Pharmaceutical, Inc.
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