`
`Filed on behalf of: Par Pharmaceutical, Inc.
`
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`
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`Entered: September 22, 2017
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_______________________
`
`PAR PHARMACEUTICAL, INC.
`Petitioner
`v.
`NOVARTIS AG
`Patent Owner
`_______________________
`Case IPR2016-01479
`U.S. Patent No. 9,006,224
`_______________________
`
`Before LORA M. GREEN, CHRISTOPHER L. CRUMBLEY, and
`ROBERT A. POLLOCK, Administrative Patent Judges.
`
`
`
`PETITIONER’S UPDATED EXHIBIT LIST
`
`
`
`
`
`
`
`
`Case IPR2016-01479
`U.S. Patent No. 9,006,224
`
`
`Pursuant to 37 C.F.R. § 42.63(e), Petitioner Par Pharmaceutical, Inc.
`
`respectfully submits the following current exhibit list.
`
`1001 U.S. Patent No. 9,006,224 (“the ’224 patent”), titled “Neuroendocrine
`Tumor Treatment”
`
`1002 File History for the ’224 patent
`
`1003 Declaration of Mark J. Ratain, M.D. in Support of Petition for Inter Partes
`Review of U.S. Patent No. 9,006,224 (“Ratain Decl.”)
`
`1004 Curriculum Vitae of Mark J. Ratain, M.D.
`
`1005 A. Boulay et al., Antitumor efficacy of intermittent treatment schedules with
`the rapamycin derivative RAD001 correlates with Prolonged Inactivation
`of Ribosomal Protein S6 Kinase 1 in Peripheral Blood Mononuclear Cells,
`64 CANCER RES. 252 (2004) (“Boulay 2004”)
`
`1006 E. Brown et al., A mammalian protein targeted by G1-arresting rapamycin-
`receptor complex, 369 NATURE 756 (1994) (“Brown”)
`
`1007 P. Buetow et al., Islet cell tumors of the Pancreas: Pathologic-Imaging
`Correlation Among Size, Necrosis and Cysts, Calcification, Malignant
`Behavior, and Functional Status, 165 AM. J. ROENTGENOLOGY 1175 (1995)
`
`1008 Center for Drug Evaluation & Research, Approval Package for NDA
`021083 (Rapamune), Food & Drug Administration (Sept. 15, 1999)
`
`1009 J. Dancey, Clinical development of mammalian target of rapamycin
`inhibitors, 16 HEMATOLOGY/ONCOLOGY CLINICS OF N. AM. 1101 (2002)
`(“Dancey”)
`
`1010 M. De Jong et al., Therapy of neuroendocrine tumors with radiolabeled
`somatostatin-analogues, 43 Q. J. NUCLEAR MED. & MOLECULAR
`IMAGING 356 (1999) (“De Jong”)
`
`1011 I. Duran et al., A Phase II Trial of Temsirolimus in Metastatic
`Neuroendocrine Carcinomas (NECs), 23 SUPPL. J. CLIN. ONCOL. 3096
`(2005) (“Duran”)
`
`
`
`1
`
`
`
`Case IPR2016-01479
`U.S. Patent No. 9,006,224
`
`1012 J. Dutcher, Mammalian target of rapamycin inhibition, 10 CLIN. CANCER
`RES. 6382s (2004) (“Dutcher”)
`
`1013 C. P. Eng et al., Activity of Rapamycin (AY-22,989) Against Transplanted
`Tumors, 37 J. ANTIBIOTICS 1231 (1984) (“Eng”)
`
`1014 M. Grewe et al., Regulation of Cell Growth and Cyclin D1 Expression by
`the Constitutively Active FRAP-p70s6K Pathway in Human Pancreatic
`Cancer Cells, 59 CANCER RES. 3581 (1999) (“Grewe”)
`
`1015 M. Guba et al., Rapamycin inhibits primary and metastatic tumor growth
`by antiangiogenesis: involvement of vascular endothelial growth factor, 8
`NATURE MED. 128 (2002) (“Guba”)
`
`1016 M. Hidalgo et al., The rapamycin-sensitive signal transduction pathway as
`a target for cancer therapy, 19 ONCOGENE 6680 (2000) (“Hidalgo”)
`
`1017 S. Huang et al., Inhibitors of mammalian target of rapamycin as novel
`antitumor agents: from bench to clinic, 3 CURRENT OPINION IN
`INVESTIGATIONAL DRUGS 295 (2002) (“Huang 2002”)
`
`1018 S. Huang et al., Rapamycins: Mechanism of Action and Cellular
`Resistance, 2 CANCER BIOL. & THER. 222 (2003) (“Huang 2003”)
`
`1019 M. Levy and M. Wiersema, Pancreatic neoplasms, 15 GASTROINTESTINAL
`ENDOSCOPY CLIN. N. AM. 117 (2005) (“Levy”)
`
`1020 G. Kaltsas et al., The Diagnosis and Medical Management of Advanced
`Neuroendocrine Tumors, 25 ENDOCRINE REV. 458 (2004) (“Kaltsas”)
`
`1021 R. Martel et al., Inhibition of the immune response by rapamycin, a new
`antifungal antibiotic, 55 CAN. J. PHYSIOL. PHARMACOL. 48 (1977)
`(“Martel”)
`
`1022 R. Morris, Rapamycins: Antifungal, Antitumor, Antiproliferative, and
`Immunosuppressive Macrolides, 6 TRANSPLANTATION REV. 39 (1992)
`(“Morris”)
`
`1023 C. Moertel et al., Streptozocin-Doxorubicin, Streptozocin-Fluorouracil, or
`Chlorozotocin in the Treatment of Advanced Islet-Cell Carcinoma, 326
`NEW ENG. J. MED. 519 (1992) (“Moertel”)
`
`
`
`2
`
`
`
`Case IPR2016-01479
`U.S. Patent No. 9,006,224
`
`1024 M. Neshat et al., Enhanced sensitivity of PTEN-deficient tumors to
`inhibition of FRAP/mTOR, 98 PNAS 10314 (2001) (“Neshat”)
`
`1025 K. Öberg, Chemotherapy and biotherapy in the treatment of
`neuroendocrine tumours, 12 ANN. ONCOL. S111 (2001) (“Öberg 2001”)
`
`1026 K. Öberg, Management of neuroendocrine tumors, 15 ANN. ONCOLOGY
`iv293 (2004)
`
`1027 K. Öberg, Treatment of neuroendocrine tumors of the gastrointestinal tract,
`27 ONCOLOGIA 57 (2004) (“Öberg 2004”)
`
`1028 K. Öberg and B. Eriksson, Endocrine tumours of the pancreas, 19 BEST
`PRACTICE & RES. CLIN. GASTROENT. 753 (2005) (“Öberg & Eriksson”)
`
`1029 A. O’Donnell et al., A phase I study of the oral mTOR inhibitor RAD001 as
`a monotherapy to identify the optimal biologically effective dose using
`toxicity, pharmacokinetic (PK) and pharmacodynamics (PD) endpoints in
`patients with solid tumors, 22 PROC. AM. SOC’Y OF CLINICAL ONCOLOGY
`200(803ab) (2003) (“O’Donnell”)
`
`1030 T. O’Reilly et al., In vivo activity of RAD001, an orally active rapamycin
`derivative, in experimental tumor models, 43 PROC. AM. ASS’N OF CANCER
`RES. 71 (Abstract #359) (2002) (“O’Reilly”)
`
`1031 A. Perren, et al., Mutation and expression analyses reveal differential
`subcellular compartmentalization of PTEN in endocrine pancreatic tumors
`compared to normal islet cells, 157 AM. J. PATHOLOGY 1097 (2000)
`(“Perren”)
`
`1032 U. Plöckinger et al., Guidelines for the Diagnosis and Treatment of
`Neuroendocrine Gastrointestinal Tumours, 80 NEUROENDOCRINOLOGY 394
`(2004) (“NET Guidelines”)
`
`1033 R. Rao et al., Mammalian Target of Rapamycin (mTOR) Inhibitors as Anti-
`Cancer Agents, 4 CURR. CANCER DRUG TARGETS 621 (2004) (“Rao”)
`
`1034 C. Sawyers, Will mTOR inhibitors make it as cancer drugs?, 4 CANCER
`CELL 343 (2003) (“Sawyers”)
`
`
`
`3
`
`
`
`Case IPR2016-01479
`U.S. Patent No. 9,006,224
`
`1035 S. Schreiber, Chemistry and biology of the immunophilins and their
`immunosuppressive ligands, 251 SCIENCE 283 (1991) (“Schreiber”)
`
`1036 W. Schuler et al., SDZ RAD, a new rapamycin derivative: pharmacological
`properties in vitro and in vivo, 64 TRANSPLANTATION 36 (1997)
`(“Schuler”)
`
`1037 A. Tolcher, Novel therapeutic molecular targets for prostate cancer: the
`mTOR signaling pathway and epidermal growth factor receptor, 171 J.
`UROLOGY S41 (2004) (“Tolcher”)
`
`1038 J. Tabernero et al., A phase I study with tumor molecular
`pharmacodynamic (MPD) evaluation of dose and schedule of the oral
`mTOR-inhibitor Everolimus (RAD001) in patients (pts) with advanced solid
`tumors, 23 J. CLINICAL ONCOLOGY 3007 (2005) (“Tabernero”)
`
`1039 S. Vignot et al., mTOR-targeted therapy of cancer with rapamycin
`derivatives, 16 ANN. ONCOL. 525 (2005) (“Vignot”)
`
`1040 U.S. Patent No. 3,929,992 (“the ’992 patent”)
`
`1041 U.S. Patent No. 4,650,803 (“the ’803 patent”)
`
`1042 U.S. Patent No. 4,885,171 (“the ’171 patent”)
`
`1043 U.S. Patent No. 5,100,883 (“the ’883 patent”)
`
`1044 U.S. Patent No. 5,206,018 (“the ’018 patent”)
`
`1045 U.S. Patent No. 5,233,036 (“the ’036 patent”)
`
`1046 U.S. Patent No. 5,362,718 (“the ’718 patent”)
`
`1047 U.S. Patent No. 5,391,730 (“the ’730 patent”)
`
`1048 U.S. Patent No. 5,665,772 (“the ’772 patent”)
`
`1049 U.S. Patent No. 7,091,213 (“the ’213 patent”)
`
`1050 U.S. Patent No. 8,410,131 (“the ’131 patent”)
`
`
`
`4
`
`
`
`Case IPR2016-01479
`U.S. Patent No. 9,006,224
`
`1051 L. Wang et al., Differential Expression of the PTEN Tumor Suppressor
`Protein in Fetal and Adult Neuroendocrine Tissues and Tumors:
`Progression Loss of PTEN Expression in Poorly Differentiated
`Neuroendocrine Neoplasms, 10 APPLIED IMMUNOHISTOCHEMISTRY &
`MOLECULAR MORPHOLOGY 139 (2002) (“Wang 2002”)
`
`1052 B. Wiedenmann & U. Pape, From Basic to Clinical Research in
`Gastroenteropancreatic Neuroendocrine Tumor Disease—The Clinician-
`Scientist Perspective, 80 NEUROENDOCRINOLOGY 94 (2004) (“Wiedenmann
`2004”)
`
`1053 WO 97/47317 (“Weckbecker”)
`
`1054 WO 02/40000 (“Dukart”)
`
`1055 WO 02/066019 (“Lane”)
`
`1056 Excerpt from the file history of U.S. Application No. 14/608,644,
`Information Disclosure Statement (April 1, 2015)
`
`1057 Excerpt from the file history of U.S. Application No. 14/608,644, Office
`Action (December 18, 2015)
`
`1058 Dr. Kjell Öberg, Web Bio, Uppsala University, available at
`http://katalog.uu.se/empinfo?languageId=1&id=n96-5147, visited June 26,
`2015 (“Öberg Biography”)
`
`1059 “What is ENETS?,” available at http://www.enets.org/what_is_enets.html,
`visited June 26, 2015 (“ENETS Info”)
`
`1060 Sandostatin LAR® Prescribing Label (November 1998)
`
`1061 Declaration of Scott Bennett, Ph.D.
`
`1062 D. Clements et al., Regression of Metastatic Vipoma with Somatostatin
`Analogue SMS 201-995, Lancet 874 (1985) (“Clements”)
`
`1063 D. O’Toole et al., Chemotherapy for Gastro-Enteropancreatic Endocrine
`Tumours 80 NEUROENDOCRINOLOGY 79 (2004)
`
`
`
`5
`
`
`
`Case IPR2016-01479
`U.S. Patent No. 9,006,224
`
`1064 A. Jimeno et al., Pharmacodynamic-guided, modified continuous
`reassessment method (mCRM)-based, dose finding study of rapamycin in
`adult patients with solid tumors, 24 J. CLIN. ONCOL. 3020 (2006)
`
`1065 Declaration of Jonathan M. Strang in Response to Patent Owner’s
`Objections to Evidence [Note: This exhibit was served, but not filed]
`
`1066 Matthew H. Kulke et al., Activity of Sunitinib in Patients With Advanced
`Neuroendocrine Tumors, 26 J. CLINICAL ONCOLOGY 3403 (2008)
`[Note: This exhibit was introduced at Dr. Kulke’s Deposition]
`
`1067 Paula Moyer, GIST Shows Response to SU11248—If Looking for Right
`Biomarkers, 27 ONCOLOGY TIMES 59 (2005)
`[Note: This exhibit was introduced at Dr. Kulke’s Deposition]
`
`1068 Jennifer A. Chan et al., Prospective Study of Bevacizumab Plus
`Temozolomide in Patients With Advanced Neuroendocrine Tumors, 24 J.
`CLINICAL ONCOLOGY 2964 (2012)
`[Note: This exhibit was introduced at Dr. Kulke’s Deposition]
`
`1069 Mace L. Rothenberg, SUTENT® (sunitinib malate) Capsules (2011)
`[Note: This exhibit was introduced at Dr. Kulke’s Deposition]
`
`1070 Transcript of July 12, 2017 Deposition of Matthew H. Kulke, M.D.
`
`1071 Alexandre Mathy et al., Limited Efficacy of Imatinib Mesylate in Malignant
`Mesothelioma: A Phase II Trial, 50 LUNG CANCER 83 (2005)
`
`1072 M. T. Barakat et al., Neuroendocrine Tumours, 11 ENDOCRINE-RELATED
`CANCER 1 (2004)
`
`1073 J. Verweij et al, Imatinib Mmesylate (STI-571 Glivec®, Gleevec™) is an
`Active Agent for Gastrointestinal Stromal Tumours, but Does Not Yield
`Responses in Other Soft-Tissue Sarcomas That are Unselected for a
`Molecular Target: Results From an EORTC Soft Tissue and Bone Sarcoma
`Group Phase II Study, 39 EUR. J. CANCER 2006 (2003)
`
`1074 RESERVED
`
`1075 National Center for Biotechnology Information, PubMed – Search results
`for “ca20948” (July 28, 2017), https://www.ncbi.nlm.nih.gov/pubmed
`
`
`
`6
`
`
`
`Case IPR2016-01479
`U.S. Patent No. 9,006,224
`
`1076 Jennifer Chan and Matthew Kulke, Targeting the mTOR Signaling Pathway
`in Neuroendocrine Tumors, 15 CURRENT TREATMENT OPTIONS IN
`ONCOLOGY 365 (2014)
`
`1077 Charles Grudzinskas, Chapter 33: Design of Clinical Development
`Programs, PRINCIPLES OF CLINICAL PHARMACOLOGY 501 (2d. ed. 2007)
`
`1078 Ezra E. W. Cohen et al., Phase II Trial of ZD1839 in Recurrent or
`Metastatic Squamous Cell Carcinoma of the Head and Neck, 21 J.
`CLINICAL ONCOLOGY 1980 (2003)
`
`1079 Cell & Gene Therapy World, Speakers – Dr. David Lebwohl (July 27,
`2017), http://www.bioleaders-forum.com/speakers/david-lebwohl
`
`1080 RESERVED
`
`1081 Mark D. DeMario et al., A Phase I Study of Oral Uracil/Ftorafur (UFT)
`Plus Leucovorin and Bis-acetato-ammine-dichloro-cyclohexylamine-
`platinum IV (JM-216) Each Given Over 14 Days Every 28 Days, 43
`CANCER CHEMOTHERAPY AND PHARMACOLOGY 385 (1999)
`
`1082 A. A. Desai et al., A Phase I Trial of a Novel mTOR Inhibitor AP23573
`Administered Weekly (wkly) in Patients (pts) with Refractor or Advanced
`Malignancies: A Pharmacokinetic (PK) and Pharmacodynamic (PD)
`Analysis, 22 J. CLINICAL ONCOLOGY 231S (2004)
`
`1083 A. A. Desai et al., Development of a Pharmacokinetic (PK) Model and
`Assessment of Patient (pt) Covariate Effects on Dose-Dependent PK
`Following Different Dosing Schedules in Two Phase I Trials of AP23573
`(AP), a mTOR Inhibitor, 23 J. CLINICAL ONCOLOGY 202S (2005)
`
`1084 RESERVED
`
`1085 U.K. Patent Application No. 0124957.2
`
`1086 RESERVED
`
`1087 RESERVED
`
`1088 RESERVED
`
`
`
`7
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`Case IPR2016-01479
`U.S. Patent No. 9,006,224
`
`1089 Pedram Heidari et al., Free Somatostatin Receptor Fraction Predicts the
`Antiproliferative Effect of Octreotide in a Neuroendocrine Tumor Model:
`Implications for Dose Optimization, 73 CANCER RES. 6865 (2013)
`
`1090 T. J. Hobday et al., Preliminary Results of a Phase II Trial of Gefitnib in
`Progressive Metastatic Neuroendocrine Tumors (NET): A Phase II
`Consortium (P2C) Study, 23 J. CLINICAL ONCOLOGY 328S (2005)
`
`1091 Thomas P. Johnston et al., Synthesis of Chlorozotocin, the 2-Chloroethyl
`Analog of the Anticancer Antibiotic Streptozotocin, 18 J. MEDICINAL
`CHEMISTRY 104 (1975)
`
`1092 Stanley B. Kaye, Clinical Drug Resistance: The Role of Factors Other
`Than P-Glycoprotein, 99 AM. J. MED. 6A-40S (1995)
`
`1093 RESERVED
`
`1094 RESERVED
`
`1095 Excerpts of Transcript of Trial Testimony of Matthew Kulke (November
`29, 2012), Pfizer Inc. et al. v. Mylan Pharmaceuticals (D. Del. C.A. No.
`10-528-GMS)
`
`1096 Larry K. Kovls and Martin Buck, Chemotherapy of Metastatic Carcinoid
`and Islet Cell Tumors: A Review, 82 AM. J. MED. 77 (1987)
`
`1097 National Center for Biotechnology Information, PubMed – Search results
`for “lebwohl-de OR lebwohl-d NOT lebwohl-dj” (July 27, 2017),
`https://www.ncbi.nlm.nih.gov/pubmed
`
`1098 Vikas Malhotra and Michael C. Perry, Classical Chemotherapy:
`Mechanisms, Toxicities and the Therapeutic Window, 2 CANCER BIOLOGY
`& THERAPY S2 (2003)
`
`1099 RESERVED
`
`1100 National Center for Biotechnology Information, PubMed – Search results
`for “marks-pw” (July 27, 2017), https://www.ncbi.nlm.nih.gov/pubmed
`
`
`
`8
`
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`Case IPR2016-01479
`U.S. Patent No. 9,006,224
`
`1101 A. David McCollum et al., Lack of Efficacy of Streptozocin and
`Doxorubicin in Patients With Advanced Pancreatic Endocrine Tumors, 27
`AM. J. CLINICAL ONCOLOGY 485 (2004)
`
`1102 Medicines and Healthcare Products Regulatory Agency – UK Public
`Assessment Report, Epirubicin Hydrochloride 10 mg and 50 mg Powder
`for Solution for Injection (2012)
`
`1103 RESERVED
`
`1104 ClinicalTrials.gov Archive – View of NCT00093782 on 2005_06_23,
`https://clinicaltrials.gov/archive/NCT00093782/2005_06_23
`
`1105 RESERVED
`
`1106 P. H. O’Donnell and M. J. Ratain, Evaluating the Activity of Temsirolimus
`in Neuroendocrine Cancer, 96 BRITISH J. CANCER 177 (2006)
`
`1107 Pfizer Canada, Product Monograph for Pharmorubicin PFS (Epirubicin
`Hydrochloride Injection) (2014),
`http://www.pfizer.ca/sites/g/files/g10017036/f/201410/pharmorubicin-pm-
`173657-E.pdf
`
`1108 A. A. Desai et al., Development of a Pharmacokinetic (PK) Model and
`Assessment of Patient (pt) Covariate Effects on Dosedependent PK
`Following Different Dosing Schedules in Two Phase I Trials of AP23573
`(AP), a mTOR Inhibitor (2005)
`
`1109 Medicines Evaluation Board in the Netherlands - Public Assessment
`Report, Epirubicine Hydrochloride 2 mg/ml, Solution for Injection or
`Infusion (2009)
`
`1110 RESERVED
`
`1111 Richard L. Schilsky et al., Phase I and Pharmacokinetic Study of Vatalanib
`Plus Capecitabine in Patients with Advanced Cancer, 3 TARGETED
`ONCOLOGY 11 (2008)
`
`
`
`9
`
`
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`Case IPR2016-01479
`U.S. Patent No. 9,006,224
`
`1112 Manisha H. Shah et al., Phase II Study of the Proteasome Inhibitor
`Bortezomib (PS-341) in Patients with Metastatic Neuroendocrine Tumors,
`10 CLINICAL CANCER RES. 6111 (2004)
`
`1113 RESERVED
`
`1114 Sutent Package Insert (Revised 2015)
`
`1115 Temsirolimus, 5 DRUGS IN R&D 363 (2004)
`
`1116 Howard A. Burris III, Dual Kinase Inhibition in the Treatment of Breast
`Cancer: Initial Experience with the EGFR/ErbB-2 Inhibitor Lapatinib, 9
`ONCOLOGIST 10 (2004)
`
`1117 RESERVED
`
`1118 Thomas E. Witzig et al., Phase II Trial of Single-Agent Temsirolimus (CCI-
`779) for Relapsed Mantle Cell Lymphoma, 23 J. CLINICAL ONCOLOGY 5347
`(2005)
`
`1119 Supplemental Declaration of Mark J. Ratain, M.D. In Support of
`Petitioner’s Reply in the Inter Partes Review of U.S. Patent No. 9,006,224
`
`1120 Food and Drug Administration Organization – Meet Peter Marks, M.D.,
`Ph.D., Director, Center for Biologics Evaluation and Research (July 27,
`2017), https://www.fda.gov/AboutFDA/CentersOffices/ucm481936.htm
`
`1121 Excerpts from Novartis’s Statement of Disputed Facts, Exhibit 2 to Pre-
`trial Order, Novartis Pharm. Corp. v. West-Ward Pharm. Int’l Ltd. (C.A.
`No. 1:15-cv-00474-RGA) (D. Del May 10, 2017)
`
`1122 U.S. Patent No. 5,194,447
`
`1123 U.S. Patent No. 5,932,243
`
`1124 U.S. Patent No. 6,645,970
`
`1125 Second Supplemental Declaration of Mark J. Ratain, M.D. in support of
`Petitioner’s Response to Patent Owner’s Objections to Evidence
`[Note: This exhibit was served, but not filed]
`
`
`
`10
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`
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`Case IPR2016-01479
`U.S. Patent No. 9,006,224
`
`1126 Alexandre Mathy et al., Limited Efficacy of Imatinib Mesylate in Malignant
`Mesothelioma: A Phase II Trial, 50 LUNG CANCER 83 (2005)
`[Note: This exhibit was served, but not filed]
`
`1127 Email from Andrew Kellogg, Supervisory Paralegal, USPTO to Brenda
`Danek, Attorney, Latham & Watkins (Sept. 20, 2017, 06:57 AM PDT)
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`Dated: September 22, 2017
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`Respectfully submitted,
`
`By: /Daniel G. Brown/
`
`
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`
`
`Daniel G. Brown (Reg. No. 54,005)
`daniel.brown@lw.com
`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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`Case IPR2016-01479
`U.S. Patent No. 9,006,224
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`CERTIFICATE OF SERVICE
`Pursuant to 37 C.F.R. § 42.6(e), I certify that on this 22nd day of
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`September, 2017, a copy of Petitioner’s Updated Exhibit List was served by
`
`electronic mail on Patent Owner’s lead and backup counsel at the following email
`
`addresses:
`
`Nicholas N. Kallas (Reg. No. 31,530)
`Raymond R. Mandra (Reg. No. 34,382)
`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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`By: /Daniel G. Brown/
`
`
`
`
`Daniel G. Brown (Reg. No. 54,005)
`daniel.brown@lw.com
`Latham & Watkins LLP
`885 Third Avenue
`New York, NY 10022-4834
`212.906.1200; 212.751.4864 (Fax)
`
`Counsel for Petitioner Par
`Pharmaceutical, Inc.
`
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