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`UNITED STATES PATENT AND TRADEMARK OFFICE
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`MYLAN PHARMACEUTICALS INC.,
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`Petitioner,
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`v.
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`NOVO NORDISK A/S,
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`Patent Owner.
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`Case No. IPR2023-00724
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`Patent No. 10,335,462
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`UPDATED LIST OF PETITIONER’S EXHIBITS
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`Pursuant to 37 C.F.R. § 42.63(e), Petitioner submits the following current
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`exhibit list.
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`EXHIBIT
`NO.
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`1001
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`1002
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`1003
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`1004
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`1005
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`
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`DESCRIPTION
`
`U.S. Patent No. 10,335,462
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`Prosecution history excerpts for U.S. Patent No. 10,335,462
`
`Declaration of John Bantle, MD
`
`CV of John Bantle, MD
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`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.
`
`1009
`
`Intentionally Left Blank
`
`1010
`
`Intentionally Left Blank
`
`1011 WO 2011/138421
`
`1012
`
`1013
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`1014
`
`1015
`
`Lovshin, Incretin-Based Therapies for Type 2 Diabetes Mellitus, 5
`NATURE REV. ENDOCRINOLOGY 262 (2009)
`
`Clinical Trial No. NCT00696657
`
`Clinical Trial No. NCT00851773
`
`WO 2006/097537
`
`1016
`
`U.S. Patent Application Pub. No. US2007/0010424
`
`1017
`
`U.S. Patent No. 5,512,549
`
`1018
`
`1019
`
`Banting, The Internal Secretion of the Pancreas, 7 J. LAB.
`CLINICAL MED. 251 (1922)
`
`Bell, Hamster Preproglucagon Contains the Sequence of Glucagon
`and Two Related Peptides, 302 NATURE 716 (1983)
`
`1
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`
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`EXHIBIT
`NO.
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`DESCRIPTION
`
`1020
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`Bydureon prescribing information (Jan. 2012)
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`1021
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`Byetta prescribing information (Oct. 2009)
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`1022
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`1023
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`1024
`
`1025
`
`1026
`
`1027
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`1028
`
`1029
`
`1030
`
`Drab, Incretin-Based Therapies for Type 2 Diabetes Mellitus:
`Current Status and Future Prospects, 30 PHARMACOTHERAPY 609
`(2010)
`
`Drucker, Enhancing Incretin Action for the Treatment of Type 2
`Diabetes, 26 DIABETES CARE 2929 (2003)
`
`Drucker, The Incretin System: Glucagon-Like Peptide-1 Receptor
`Agonists and Dipeptidyl Peptidase-4 Inhibitors in Type 2 Diabetes,
`368 LANCET 1696 (2006)
`
`Glaesner, Engineering and Characterization of the Long-Acting
`Glucagon-Like Peptide-1 Analogue LY2189265, an Fc Fusion
`Protein, 26 DIABETES/METABOLISM RSCH. & REV. 287 (2010)
`
`HARRISON’S PRINCIPLES OF INTERNAL MED., Chapter 338 (Fauci et
`al. eds. 17th ed. 2008)
`
`Holst, Truncated Glucagon-like Peptide I, an Insulin-Releasing
`Hormone from the Distal Gut, 211 (2) FEBS LETTERS 169 (1987)
`
`Holst, Glucagon-Like Peptide 1 and Inhibitors of Dipeptidyl
`Peptidase IV in the Treatment of Type 2 Diabetes Mellitus, 4
`CURRENT OP. IN PHARMACOLOGY 589 (2004)
`
`Jimenez-Solem, Dulaglutide, a Long-Acting GLP-1 Analog Fused
`with an Fc Antibody Fragment for the Potential Treatment of Type
`2 Diabetes, 12 CURRENT OP. IN MOLECULAR THERAPEUTICS 790
`(2010)
`
`Kim, Effects of Once-Weekly Dosing of a Long-Acting Release
`Formulation of Exenatide on Glucose Control and Body Weight in
`Subjects with Type 2 Diabetes, 30 DIABETES CARE 1487 (2007)
`
`2
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`EXHIBIT
`NO.
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`1031
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`1032
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`1033
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`DESCRIPTION
`
`Knudsen, GLP-1 Derivatives as Novel Compounds for the
`Treatment of Type 2 Diabetes: Selection of NN2211 for Clinical
`Development, 26 DRUGS OF THE FUTURE 677 (2001)
`
`Knudsen, Glucagon-like Peptide-1: The Basis of a New Class of
`Treatment for Type 2 Diabetes, 47 J. MED. CHEMISTRY 4128 (2004)
`
`Knudsen, Liraglutide, a GLP-1 Analogue to Treat Diabetes, in
`ANALOGUE-BASED DRUG DISCOVERY II (Fischer & Ganellin eds.
`2010)
`
`1034
`
`U.S. Patent No. 6,268,343 (“Knudsen patent”)
`
`1035
`
`Lund, Emerging GLP-1 Receptor Agonists, 16 EXPERT OP. ON
`EMERGING DRUGS 607 (2011)
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`1036
`
`1037
`
`1038
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`Mojsov, Insulinotropin: Glucagon-like Peptide I (7-37) Co-
`encoded in the Glucagon Gene is a Potent Simulator of Insulin
`Release in the Perfused Rat Pancreas, 79 J. CLINICAL
`INVESTIGATION 616 (1987)
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`Nielsen, Pharmacology of Exenatide (Synthetic Exendin-4): A
`Potential Therapeutic for Improved Glycemic Control of Type 2
`Diabetes, 117 REGUL. PEPTIDES 77 (2004)
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`Seino, Dose-Dependent Improvement in Glycemia with Once-Daily
`Liraglutide without Hypoglycemia or Weight Gain: A Double-
`Blind, Randomized, Controlled Trial in Japanese Patients with
`Type 2 Diabetes, 81 DIABETES RSCH. & CLINICAL PRACTICE 161
`(2008)
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`1039
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`Victoza, PHYSICIANS’ DESK REFERENCE (65th ed. 2010)
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`1040
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`Vilsbøll, Glucagon-Like Peptide-1 and Diabetes Treatment, 21
`INT’L DIABETES MONITOR 1 (2009)
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`1041
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`WO 03/002136
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`1042
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`WO 91/11457
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`3
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`EXHIBIT
`NO.
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`DESCRIPTION
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`1043
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`U.S. Patent App. Pub. 2004/0102486
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`1044
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`1045
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`1046
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`1047
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`1048
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`1049
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`1050
`
`1051
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`1052
`
`Rohatagi, Model-Based Development of a PPARγ Agonist,
`Rivoglitazone, to Aid Dose Selection and Optimize Clinical Trial
`Designs, 48 J. CLINICAL PHARMACOLOGY 1420 (2008)
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`Shargel, APPLIED BIOPHARMACEUTICS & PHARMACOKINETICS (5th
`ed. 2005)
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`Yun, Pharmacokinetic and Pharmacodynamic Modelling of the
`Effects of Glimepiride on Insulin Secretion and Glucose Lowering
`in Healthy Humans, 31 J. CLINICAL PHARMACY & THERAPEUTICS
`469 (2006)
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`Tamimi, Drug Development: From Concept to Marketing!, 113
`NEPHRON CLINICAL PRACTICE c125 (2009)
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`FDA Guidance for Industry, Exposure-Response Relationships -
`Study Design, Data, Analysis, and Regulatory Applications (Apr.
`2003)
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`International Conference on Harmonisation; Dose-Response
`Information to Support Drug Registration; Guideline; Availability,
`59 Fed. Reg. 55972 (Nov. 9, 1994) (“ICH 1994”)
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`Garber, Efficacy of Metformin in Type II Diabetes: Results of a
`Double-Blind, Placebo-Controlled, Dose-Response Trial, 102 AM.
`J. MED. 491 (1997)
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`Landersdorfer, Pharmacokinetic/Pharmacodynamic Modelling in
`Diabetes Mellitus, 47(7) CLINICAL PHARMACOKINETICS 417 (2008)
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`Madsbad, An Overview of Once-Weekly Glucagon-Like Peptide-1
`Receptor Agonists—Available Efficacy and Safety Data and
`Perspectives for the Future, 13 DIABETES, OBESITY & METABOLISM
`394 (2011)
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`4
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`EXHIBIT
`NO.
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`1053
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`1054
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`1055
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`1056
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`1057
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`1058
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`1059
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`1060
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`1061
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`1062
`
`1063
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`DESCRIPTION
`
`Møller, Mechanism-Based Population Modelling for Assessment of
`L-Cell Function Based on Total GLP-1 Response Following an
`Oral Glucose Tolerance Test, 38 J. PHARMACOKINETICS &
`PHARMACODYNAMICS 713 (2011)
`
`Landersdorfer, Mechanism-Based Population Pharmacokinetic
`Modelling in Diabetes: Vildagliptin as a Tight Binding Inhibitor
`and Substrate of Dipeptidyl Peptidase IV, 73 BRIT. J. CLINICAL
`PHARMACOLOGY 391 (2011) (“Landersdorfer 2011a”)
`
`Landersdorfer, Mechanism-Based Population Modelling of the
`Effects of Vildagliptin on GLP-1, Glucose and Insulin in Patients
`with Type 2 Diabetes, 73 BRIT. J. CLINICAL PHARMACOLOGY 373
`(2011) “(Landersdorfer 2011b”)
`
`U.S. Patent No. 5,118,666
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`WO 2011/073328
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`Blonde, Comparison of Liraglutide Versus Other Incretin-Related
`Anti-Hyperglycaemic Agents, 14 (suppl. 2) DIABETES, OBESITY &
`METABOLISM 20 (2012)
`
`Murphy, Review of the Safety and Efficacy of Exenatide Once
`Weekly for the Treatment of Type 2 Diabetes Mellitus, 46 ANNALS
`OF PHARMACOTHERAPY 812 (2012)
`
`WO 2011/058193
`
`U.S. Patent App. Pub. No. 2011/0166321
`
`Zarin, The ClinicalTrials.gov Results Database—Update and Key
`Issues, 364 NEW ENGL. J. MED. 852 (2011)
`
`Kirillova, Results and Outcome Reporting in ClinicalTrials.gov,
`What Makes it Happen?, 7(6) PLOS ONE 1 (2012)
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`5
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`EXHIBIT
`NO.
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`1064
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`1065
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`1066
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`1067
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`1068
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`1069
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`1070
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`1071
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`1072
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`1073
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`1074
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`1075
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`1076
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`1077
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`DESCRIPTION
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`Monami, Effects of Glucagon-Like Peptide-1 Receptor Agonists on
`Body Weight: A Meta-Analysis, 2012 EXPERIMENTAL DIABETES
`RSCH. 1 (2012)
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`Tasneem, The Database for Aggregate Analysis of
`ClinicalTrials.gov (AACT) and Subsequent Regrouping by Clinical
`Specialty, 7(3) PLOS ONE 1(2012)
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`Knudsen, Liraglutide: The Therapeutic Promise from Animal
`Models, 64(suppl 167) INT’L J. CLINICAL PRACTICE 4 (2010)
`(“Knudsen 2010b”)
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`U.S. Patent No. 8,536,122
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`U.S. Patent No. 8,129,343
`
`REMINGTON: THE SCIENCE AND PRACTICE OF PHARMACY (Alfonso
`R. Gennaro ed., 20th ed. 2000)
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`Boylan, Parenteral Products, in MODERN PHARMACEUTICS (Gilbert
`S. Banker et al. eds., 3d ed. 1996)
`
`U.S. Patent No. 6,284,727
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`U.S. Patent No. 5,164,366
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`U.S. Patent No. 6,458,924
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`WO 00/37098
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`U.S. Patent No. 7,022,674
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`ClinicalTrials.gov Background, CLINICALTRIALS.GOV,
`https://clinicaltrials.gov/ct2/about-site/background (last visited
`Mar. 10, 2023)
`
`Award: ClinicalTrials.gov,
`https://ash.harvard.edu/news/clinicaltrials.gov (last visited Mar. 10,
`2023)
`
`6
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`
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`EXHIBIT
`NO.
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`DESCRIPTION
`
`1078
`
`U.S. Patent App. Pub. No. 2004/0102486
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`1079
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`1080
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`NCT00167115, CLINICALTRIALS.GOV,
`https://www.clinicaltrials.gov/ct2/show/NCT00167115 (last visited
`Mar. 10, 2023)
`
`NCT01933490, CLINICALTRIALS.GOV,
`https://www.clinicaltrials.gov/ct2/show/NCT01933490 (last visited
`Mar. 10, 2023)
`
`1081
`
`Ozempic prescribing information (Oct. 2022)
`
`1082
`
`1083
`
`1084
`
`1085
`
`1086
`
`Scheduling Order, Novo Nordisk Inc. v. Rio Biopharmaceuticals
`Inc., No. 22-294 (CFC) (D. Del. June 30, 2022), ECF No. 22
`
`Transfer Order, In re: Ozempic (Semaglutide) Patent Litigation,
`No. 3038 (MDL Aug. 5, 2022)
`
`EMA, ICH Topic S 7 A Safety Pharmacology Studies for Human
`Pharmaceuticals (June 2001)
`
`ACS Publications, https://pubs.acs.org/toc/jmcmar/47/17;
`https://pubs.acs.org/doi/10.1021/jm030630m
`
`“Last Update Posted” definition from ClinicalTrials.gov
`https://clinicaltrials.gov/ct2/show/NCT00696657
`
`1087
`
`Prosecution history excerpts for U.S. Patent No. 9,764,003
`
`1088
`
`1089
`
`1090
`
`Markman Hearing Transcript, In Re: Ozempic (Semaglutide) Patent
`Litigation, No. 22-MD-3038 (D. Del. July 13, 2023)
`
`Claim Construction Order, In Re: Ozempic (Semaglutide) Patent
`Litigation, No. 22-MD-3038 (D. Del. July 25, 2023), ECF No. 148
`
`Joint Claim Construction Brief, In Re: Ozempic (Semaglutide)
`Patent Litigation, No. 22-MD-3038 (D. Del. May 1, 2023), ECF
`No. 119
`
`7
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`
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`EXHIBIT
`NO.
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`1091
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`1092
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`1093
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`DESCRIPTION
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`Declaration of Shannon M. Bloodworth in Support of Motion for
`Pro Hac Vice Admission of Shannon M. Bloodworth
`
`Declaration of David L. Anstaett in Support of Motion for Pro Hac
`Vice Admission of David L. Anstaett
`
`Declaration of Bryan D. Beel in Support of Motion for Pro Hac
`Vice Admission of Bryan D. Beel
`
`
`
`Dated: December 18, 2023
`
`
`PERKINS COIE LLP
`700 Thirteenth Street, N.W., Suite 800
`Washington, D.C. 20005-3960
`202.654.6200 (phone)
`202.654.6211 (fax)
`
`
`
`
`Respectfully submitted,
`
`/Brandon M. White/
`Lead Counsel
`Brandon M. White, Reg No. 52,354
`
`
`
`
`Attorneys for Petitioner
`
`8
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`
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`CERTIFICATE OF SERVICE
`
`Pursuant to 37 C.F.R. § 42.6(e), I certify that I caused to be served a true and
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`correct copy of the foregoing: UPDATED LIST OF PETITIONER’S EXHIBITS
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`and Exhibits 1091 – 1093 by email to the electronic service addresses for Patent
`
`Owner
`
`
`
`J. Steven Baughman
`GROOMBRIDGE, WU, BAUGHMAN & STONE LLP
`steve.baughman@groombridgewu.com
`
`Megan Raymond
`GROOMBRIDGE, WU, BAUGHMAN & STONE LLP
`megan.raymond@groombridgewu.com
`
`Novo-Semaglutide-IPR@groombridgewu.com
`
`Dated: December 18, 2023
`
`
`PERKINS COIE LLP
`700 Thirteenth Street, N.W., Suite 800
`Washington, D.C. 20005-3960
`202.654.6200 (phone)
`202.654.6211 (fax)
`
`
`
`
`/Brandon M. White/
`Lead Counsel
`Brandon M. White, Reg No. 52,354
`
`
`Attorneys for Petitioner
`
`
`
`
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