Apotex Inc. et al. vs Novo Nordisk A/S

Termination Decision: Post-DI Settlement

Order: Order on Motions to Expunge

Order: On Protective Orders and Motions to Seal

Apotex's Motion to Expunge

[Redacted] Patent Owner's Reply to Petitioner's Reply to Patent Owner's Preliminary Response

Institution Decision: Granting Institution of Inter Partes Review 35 U.S.C. sec. 314 Granting Motion for Joinder 35 U.S.C. sec. 315c 37 C.F.R. sec. 42.122

Order: Conduct of the Proceeding 37 C.F.R. sec. 42.5

Patent Owner's Motion to Seal

EXPUNGED

Redacted - Patent Owner's Preliminary Response

EXPUNGED

Redacted - Apotex's Reply to Patent Owner's Preliminary Response

Apotex's Third Motion to Seal

Patent Owner's Motion to Seal

EXPUNGED

EX2001 - Docket Sheet from PTACTS, Mylan Pharms. Inc. v. Novo Nordisk A/S, IPR2023-00724

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

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

EX2004 - Excerpted Patent Owner’s Response, Mylan Pharms. Inc. v. Novo Nordisk A/S, IPR2023-00724, Paper 30

EX2005 - Excerpted Declaration of George L. Bakris, M.D., Mylan Pharms. Inc. v. Novo Nordisk A/S, IPR2023-00724, EX2011

EX2006 - Excerpted Declaration of Robin S. Goland, M.D., Mylan Pharms. Inc. v. Novo Nordisk A/S, IPR2023-00724, EX2054

EX2007 - Excerpted Declaration of Michael J. Blaha, M.D., Mylan Pharms. Inc. v. Novo Nordisk A/S, IPR2023-00724, EX2055

EX2008 - Excerpted Declaration of Christopher A. Vellturo, Ph.D., Mylan Pharms. Inc. v. Novo Nordisk A/S, IPR2023-00724, EX2300

EX2009 - Excerpted Declaration of Patrick J. Sinko, Ph.D., Mylan Pharms. Inc. v. Novo Nordisk A/S, IPR2023-00724, EX2056

EXPUNGED

EX2011 - Patent Exclusivity for N209637 (Semaglutide/Ozempic), Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations, U.S. Food & Drug Administration

EX2012 - Declaration of Sayem Osman

EXPUNGED

Apotex's Motion to Seal

Redacted - Apotex's Reply to Patent Owner's Opposition to Petitioner's Motion for Joinder

Redacted - Patent Owner's Opposition to Petitioner's Motion for Joinder (Paper No. 9)

EXPUNGED

Notice: Notice filing date accorded

Exhibit 3001

Patent Owner's Power of Attorney & Designation of Lead and Back-Up Counsel

Patent Owner's Mandatory Notices

1001 U.S. Patent No. 10,335,462

1002 Prosecution history excerpts for U.S. Patent No. 10,335,462

CV of John Bantle, MD

1005 Declaration of William J. Jusko, Ph.D.

1006 CV of William J. Jusko, Ph.D.

1007 Declaration of Paul Dalby, Ph.D.

1008 CV of Paul Dalby, Ph.D.

1011 WO 2011/138421

1012 Lovshin, Incretin-Based Therapies for Type 2 Diabetes Mellitus, 5 NATU

1013 Clinical Trial No. NCT00696657

1014 Clinical Trial No. NCT00851773

1015 WO 2006/097537

1016 U.S. Patent Application Pub. No. US2007/0010424

1017 U.S. Patent No. 5,512,549

1018 Banting, The Internal Secretion of the Pancreas, 7 J. LAB. CLINICAL ME

1019 Bell, Hamster Preproglucagon Contains the Sequence of Glucagon and Two

1020 Bydureon prescribing information (Jan. 2012)

1021 Byetta prescribing information (Oct. 2009)

1022 Drab, Incretin-Based Therapies for Type 2 Diabetes Mellitus: Current S

1023 Drucker, Enhancing Incretin Action for the Treatment of Type 2 Diabete

1024 Drucker, The Incretin System: Glucagon-Like Peptide-1 Receptor Agonist

1025 Glaesner, Engineering and Characterization of the Long-Acting Glucagon

1026 HARRISON’S PRINCIPLES OF INTERNAL MED., Chapter 338 (Fauci et al. eds.

1027 Holst, Truncated Glucagon-like Peptide I, an Insulin-Releasing Hormone

1028 Holst, Glucagon-Like Peptide 1 and Inhibitors of Dipeptidyl Peptidase

1029 Jimenez-Solem, Dulaglutide, a Long-Acting GLP­1 Analog Fused with an F

1030 Kim, Effects of Once-Weekly Dosing of a Long-Acting Release Formulatio

1031 Knudsen, GLP­1 Derivatives as Novel Compounds for the Treatment of Typ

1032 Knudsen, Glucagon-like Peptide-1: The Basis of a New Class of Treatmen

1033 Knudsen, Liraglutide, a GLP­1 Analogue to Treat Diabetes, in ANALOGUE-

1034 U.S. Patent No. 6,268,343

1035 Lund, Emerging GLP­1 Receptor Agonists, 16 EXPERT OP. ON EMERGING DRUG

1036 Mojsov, Insulinotropin: Glucagon-like Peptide I (7-37) Co-encoded in t

1037 Nielsen, Pharmacology of Exenatide (Synthetic Exendin-4): A Potential

1038 Seino, Dose-Dependent Improvement in Glycemia with Once-Daily Liraglut

1039 Victoza, PHYSICIANS’ DESK REFERENCE (65th ed. 2010)

1040 Vilsbøll, Glucagon-Like Peptide-1 and Diabetes Treatment, 21 INT’L DIA

1041 WO 03/002136

1042 WO 91/11457

1043 U.S. Patent App. Pub. 2004/0102486

1044 Rohatagi, Model-Based Development of a PPARγ Agonist, Rivoglitazone, t

1045 Shargel, APPLIED BIOPHARMACEUTICS & PHARMACOKINETICS (5th ed. 2005)

1046 Yun, Pharmacokinetic and Pharmacodynamic Modelling of the Effects of G

1047 Tamimi, Drug Development: From Concept to Marketing!, 113 NEPHRON CLIN

1048 FDA Guidance for Industry, Exposure-Response Relationships -Study Desi

1049 International Conference on Harmonisation; Dose-Response Information t

1050 Garber, Efficacy of Metformin in Type II Diabetes: Results of a Double

1051 Landersdorfer, Pharmacokinetic/Pharmacodynamic Modelling in Diabetes M

1052 Madsbad, An Overview of Once-Weekly Glucagon-Like Peptide-1 Receptor A

1053 Møller, Mechanism-Based Population Modelling for Assessment of L-Cell

1054 Landersdorfer, Mechanism-Based Population Pharmacokinetic Modelling in

1055 Landersdorfer, Mechanism-Based Population Modelling of the Effects of

1056 U.S. Patent No. 5,118,666

1057 WO 2011/073328

1058 Blonde, Comparison of Liraglutide Versus Other Incretin-Related Anti-H

1059 Murphy, Review of the Safety and Efficacy of Exenatide Once Weekly for

1060 WO 2011/058193

1061 U.S. Patent App. Pub. No. 2011/0166321

1062 Zarin, The ClinicalTrials.gov Results Database—Update and Key Issues,

1063 Kirillova, Results and Outcome Reporting in ClinicalTrials.gov, What M

1064 Monami, Effects of Glucagon-Like Peptide-1 Receptor Agonists on Body W

1065 Tasneem, The Database for Aggregate Analysis of ClinicalTrials.gov (AA

1066 Knudsen, Liraglutide: The Therapeutic Promise from Animal Models, 64(s

1067 U.S. Patent No. 8,536,122

1068 U.S. Patent No. 8,129,343

1069 REMINGTON: THE SCIENCE AND PRACTICE OF PHARMACY (Alfonso R. Gennaro ed

1070 Boylan, Parenteral Products, in MODERN PHARMACEUTICS (Gilbert S. Banke

1071 U.S. Patent No. 6,284,727

1072 U.S. Patent No. 5,164,366

1073 U.S. Patent No. 6,458,924

1074 WO 00/37098

1075 U.S. Patent No. 7,022,674

1076 ClinicalTrials.gov Background, CLINICALTRIALS.GOV, https://clinicaltri

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1078 U.S. Patent App. Pub. No. 2004/0102486

1079 NCT00167115, CLINICALTRIALS.GOV, https://www.clinicaltrials.gov/ct2/sh

1080 NCT01933490, CLINICALTRIALS.GOV, https://www.clinicaltrials.gov/ct2/sh

1081 Ozempic prescribing information (Oct. 2022)

1082 Scheduling Order, Novo Nordisk Inc. v. Rio Biopharmaceuticals Inc., No

1083 Transfer Order, In re: Ozempic (Semaglutide) Patent Litigation, No. 30

1084 EMA, ICH Topic S 7 A Safety Pharmacology Studies for Human Pharmaceuti

1085 ACS Publications, https://pubs.acs.org/toc/jmcmar/47/17; https://pubs.

1086 “Last Update Posted” definition from ClinicalTrials.gov https://clinic

1087 Prosecution history excerpts for U.S. Patent No. 9,764,003

1501 Declaration of Judith Korner, M.D., Ph.D.

1502 CV of Judith Korner, M.D., Ph.D.

1503 Declaration of Mark J. Ratain, M.D.

1504 CV of Mark J. Ratain, M.D.

1506 CV of Hugh DC Smyth, Ph.D.

EXPUNGED

1003 Bantle Declaration

1505 Declaration of Hugh DC Smyth, Ph.D.

Petition : as filed

Notice : Power of Attorney

Motion to Seal and Enter Protective Order

Motion for Joinder (redacted)

EXPUNGED