| 6/12/2024 | 06-12-2024-Patent_Owner | - Patent Owner Exhibit 2001: EX2001 - Docket Sheet from PTACTS, Mylan Pharms. Inc. v. Novo Nordisk A/S, IPR2023-00724
- Patent Owner Exhibit 2002: EX2002 - Joint Stipulation to Modify Due Dates 2, 3, 4, 5, 6, 7 and 8, Mylan Pharms. Inc. v. Novo Nordisk A/S, IPR2023-00724 Paper 47
- Patent Owner Exhibit 2003: EX2003 - June 7, 2024 Joint Stipulation to Modify Due Dates 3, 4, 5, 6, 7 and 8, Mylan Pharms. Inc. v. Novo Nordisk A/S, IPR2023-00724, Paper 56
- Patent Owner Exhibit 2004: EX2004 - Excerpted Patent Owner’s Response, Mylan Pharms. Inc. v. Novo Nordisk A/S, IPR2023-00724, Paper 30
- Patent Owner Exhibit 2005: EX2005 - Excerpted Declaration of George L. Bakris, M.D., Mylan Pharms. Inc. v. Novo Nordisk A/S, IPR2023-00724, EX2011
- Patent Owner Exhibit 2006: EX2006 - Excerpted Declaration of Robin S. Goland, M.D., Mylan Pharms. Inc. v. Novo Nordisk A/S, IPR2023-00724, EX2054
- Patent Owner Exhibit 2007: EX2007 - Excerpted Declaration of Michael J. Blaha, M.D., Mylan Pharms. Inc. v. Novo Nordisk A/S, IPR2023-00724, EX2055
- Patent Owner Exhibit 2008: EX2008 - Excerpted Declaration of Christopher A. Vellturo, Ph.D., Mylan Pharms. Inc. v. Novo Nordisk A/S, IPR2023-00724, EX2300
- Patent Owner Exhibit 2009: EX2009 - Excerpted Declaration of Patrick J. Sinko, Ph.D., Mylan Pharms. Inc. v. Novo Nordisk A/S, IPR2023-00724, EX2056
- Patent Owner Exhibit 2010: EXPUNGED
- Patent Owner Exhibit 2011: EX2011 - Patent Exclusivity for N209637 (Semaglutide/Ozempic), Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations, U.S. Food & Drug Administration
- Patent Owner Exhibit 2012: EX2012 - Declaration of Sayem Osman
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| 3/1/2024 | 03-01-2024-Petitioner | - Petitioner Exhibit 1001: 1001 U.S. Patent No. 10,335,462
- Petitioner Exhibit 1002: 1002 Prosecution history excerpts for U.S. Patent No. 10,335,462
- Petitioner Exhibit 1003: 1003 Bantle Declaration
- Petitioner Exhibit 1004: CV of John Bantle, MD
- Petitioner Exhibit 1005: 1005 Declaration of William J. Jusko, Ph.D.
- Petitioner Exhibit 1006: 1006 CV of William J. Jusko, Ph.D.
- Petitioner Exhibit 1007: 1007 Declaration of Paul Dalby, Ph.D.
- Petitioner Exhibit 1008: 1008 CV of Paul Dalby, Ph.D.
- Petitioner Exhibit 1011: 1011 WO 2011/138421
- Petitioner Exhibit 1012: 1012 Lovshin, Incretin-Based Therapies for Type 2 Diabetes Mellitus, 5 NATU
- Petitioner Exhibit 1013: 1013 Clinical Trial No. NCT00696657
- Petitioner Exhibit 1014: 1014 Clinical Trial No. NCT00851773
- Petitioner Exhibit 1015: 1015 WO 2006/097537
- Petitioner Exhibit 1016: 1016 U.S. Patent Application Pub. No. US2007/0010424
- Petitioner Exhibit 1017: 1017 U.S. Patent No. 5,512,549
- Petitioner Exhibit 1018: 1018 Banting, The Internal Secretion of the Pancreas, 7 J. LAB. CLINICAL ME
- Petitioner Exhibit 1019: 1019 Bell, Hamster Preproglucagon Contains the Sequence of Glucagon and Two
- Petitioner Exhibit 1020: 1020 Bydureon prescribing information (Jan. 2012)
- Petitioner Exhibit 1021: 1021 Byetta prescribing information (Oct. 2009)
- Petitioner Exhibit 1022: 1022 Drab, Incretin-Based Therapies for Type 2 Diabetes Mellitus: Current S
- Petitioner Exhibit 1023: 1023 Drucker, Enhancing Incretin Action for the Treatment of Type 2 Diabete
- Petitioner Exhibit 1024: 1024 Drucker, The Incretin System: Glucagon-Like Peptide-1 Receptor Agonist
- Petitioner Exhibit 1025: 1025 Glaesner, Engineering and Characterization of the Long-Acting Glucagon
- Petitioner Exhibit 1026: 1026 HARRISON’S PRINCIPLES OF INTERNAL MED., Chapter 338 (Fauci et al. eds.
- Petitioner Exhibit 1027: 1027 Holst, Truncated Glucagon-like Peptide I, an Insulin-Releasing Hormone
- Petitioner Exhibit 1028: 1028 Holst, Glucagon-Like Peptide 1 and Inhibitors of Dipeptidyl Peptidase
- Petitioner Exhibit 1029: 1029 Jimenez-Solem, Dulaglutide, a Long-Acting GLP1 Analog Fused with an F
- Petitioner Exhibit 1030: 1030 Kim, Effects of Once-Weekly Dosing of a Long-Acting Release Formulatio
- Petitioner Exhibit 1031: 1031 Knudsen, GLP1 Derivatives as Novel Compounds for the Treatment of Typ
- Petitioner Exhibit 1032: 1032 Knudsen, Glucagon-like Peptide-1: The Basis of a New Class of Treatmen
- Petitioner Exhibit 1033: 1033 Knudsen, Liraglutide, a GLP1 Analogue to Treat Diabetes, in ANALOGUE-
- Petitioner Exhibit 1034: 1034 U.S. Patent No. 6,268,343
- Petitioner Exhibit 1035: 1035 Lund, Emerging GLP1 Receptor Agonists, 16 EXPERT OP. ON EMERGING DRUG
- Petitioner Exhibit 1036: 1036 Mojsov, Insulinotropin: Glucagon-like Peptide I (7-37) Co-encoded in t
- Petitioner Exhibit 1037: 1037 Nielsen, Pharmacology of Exenatide (Synthetic Exendin-4): A Potential
- Petitioner Exhibit 1038: 1038 Seino, Dose-Dependent Improvement in Glycemia with Once-Daily Liraglut
- Petitioner Exhibit 1039: 1039 Victoza, PHYSICIANS’ DESK REFERENCE (65th ed. 2010)
- Petitioner Exhibit 1040: 1040 Vilsbøll, Glucagon-Like Peptide-1 and Diabetes Treatment, 21 INT’L DIA
- Petitioner Exhibit 1041: 1041 WO 03/002136
- Petitioner Exhibit 1042: 1042 WO 91/11457
- Petitioner Exhibit 1043: 1043 U.S. Patent App. Pub. 2004/0102486
- Petitioner Exhibit 1044: 1044 Rohatagi, Model-Based Development of a PPARγ Agonist, Rivoglitazone, t
- Petitioner Exhibit 1045: 1045 Shargel, APPLIED BIOPHARMACEUTICS & PHARMACOKINETICS (5th ed. 2005)
- Petitioner Exhibit 1046: 1046 Yun, Pharmacokinetic and Pharmacodynamic Modelling of the Effects of G
- Petitioner Exhibit 1047: 1047 Tamimi, Drug Development: From Concept to Marketing!, 113 NEPHRON CLIN
- Petitioner Exhibit 1048: 1048 FDA Guidance for Industry, Exposure-Response Relationships -Study Desi
- Petitioner Exhibit 1049: 1049 International Conference on Harmonisation; Dose-Response Information t
- Petitioner Exhibit 1050: 1050 Garber, Efficacy of Metformin in Type II Diabetes: Results of a Double
- Petitioner Exhibit 1051: 1051 Landersdorfer, Pharmacokinetic/Pharmacodynamic Modelling in Diabetes M
- Petitioner Exhibit 1052: 1052 Madsbad, An Overview of Once-Weekly Glucagon-Like Peptide-1 Receptor A
- Petitioner Exhibit 1053: 1053 Møller, Mechanism-Based Population Modelling for Assessment of L-Cell
- Petitioner Exhibit 1054: 1054 Landersdorfer, Mechanism-Based Population Pharmacokinetic Modelling in
- Petitioner Exhibit 1055: 1055 Landersdorfer, Mechanism-Based Population Modelling of the Effects of
- Petitioner Exhibit 1056: 1056 U.S. Patent No. 5,118,666
- Petitioner Exhibit 1057: 1057 WO 2011/073328
- Petitioner Exhibit 1058: 1058 Blonde, Comparison of Liraglutide Versus Other Incretin-Related Anti-H
- Petitioner Exhibit 1059: 1059 Murphy, Review of the Safety and Efficacy of Exenatide Once Weekly for
- Petitioner Exhibit 1060: 1060 WO 2011/058193
- Petitioner Exhibit 1061: 1061 U.S. Patent App. Pub. No. 2011/0166321
- Petitioner Exhibit 1062: 1062 Zarin, The ClinicalTrials.gov Results Database—Update and Key Issues,
- Petitioner Exhibit 1063: 1063 Kirillova, Results and Outcome Reporting in ClinicalTrials.gov, What M
- Petitioner Exhibit 1064: 1064 Monami, Effects of Glucagon-Like Peptide-1 Receptor Agonists on Body W
- Petitioner Exhibit 1065: 1065 Tasneem, The Database for Aggregate Analysis of ClinicalTrials.gov (AA
- Petitioner Exhibit 1066: 1066 Knudsen, Liraglutide: The Therapeutic Promise from Animal Models, 64(s
- Petitioner Exhibit 1067: 1067 U.S. Patent No. 8,536,122
- Petitioner Exhibit 1068: 1068 U.S. Patent No. 8,129,343
- Petitioner Exhibit 1069: 1069 REMINGTON: THE SCIENCE AND PRACTICE OF PHARMACY (Alfonso R. Gennaro ed
- Petitioner Exhibit 1070: 1070 Boylan, Parenteral Products, in MODERN PHARMACEUTICS (Gilbert S. Banke
- Petitioner Exhibit 1071: 1071 U.S. Patent No. 6,284,727
- Petitioner Exhibit 1072: 1072 U.S. Patent No. 5,164,366
- Petitioner Exhibit 1073: 1073 U.S. Patent No. 6,458,924
- Petitioner Exhibit 1074: 1074 WO 00/37098
- Petitioner Exhibit 1075: 1075 U.S. Patent No. 7,022,674
- Petitioner Exhibit 1076: 1076 ClinicalTrials.gov Background, CLINICALTRIALS.GOV, https://clinicaltri
- Petitioner Exhibit 1077: 1077 Award: ClinicalTrials.gov, https://ash.harvard.edu/news/clinicaltrials
- Petitioner Exhibit 1078: 1078 U.S. Patent App. Pub. No. 2004/0102486
- Petitioner Exhibit 1079: 1079 NCT00167115, CLINICALTRIALS.GOV, https://www.clinicaltrials.gov/ct2/sh
- Petitioner Exhibit 1080: 1080 NCT01933490, CLINICALTRIALS.GOV, https://www.clinicaltrials.gov/ct2/sh
- Petitioner Exhibit 1081: 1081 Ozempic prescribing information (Oct. 2022)
- Petitioner Exhibit 1082: 1082 Scheduling Order, Novo Nordisk Inc. v. Rio Biopharmaceuticals Inc., No
- Petitioner Exhibit 1083: 1083 Transfer Order, In re: Ozempic (Semaglutide) Patent Litigation, No. 30
- Petitioner Exhibit 1084: 1084 EMA, ICH Topic S 7 A Safety Pharmacology Studies for Human Pharmaceuti
- Petitioner Exhibit 1085: 1085 ACS Publications, https://pubs.acs.org/toc/jmcmar/47/17; https://pubs.
- Petitioner Exhibit 1086: 1086 “Last Update Posted” definition from ClinicalTrials.gov https://clinic
- Petitioner Exhibit 1087: 1087 Prosecution history excerpts for U.S. Patent No. 9,764,003
- Petitioner Exhibit 1501: 1501 Declaration of Judith Korner, M.D., Ph.D.
- Petitioner Exhibit 1502: 1502 CV of Judith Korner, M.D., Ph.D.
- Petitioner Exhibit 1503: 1503 Declaration of Mark J. Ratain, M.D.
- Petitioner Exhibit 1504: 1504 CV of Mark J. Ratain, M.D.
- Petitioner Exhibit 1505: 1505 Declaration of Hugh DC Smyth, Ph.D.
- Petitioner Exhibit 1506: 1506 CV of Hugh DC Smyth, Ph.D.
- Petitioner Exhibit 1507: EXPUNGED
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