UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`DR. REDDY’S LABORATORIES INC. and
`DR. REDDY’S LABORATORIES LTD.,
`
`Petitioners,
`
`v.
`
`NOVO NORDISK A/S,
`Patent Owner
`
`U.S. Patent No. 10,335,462 to Jensen
`Issue Date: July 2, 2019
`Title: Use Of Long-Acting Glp-1 Peptides
`
`Inter Partes Review No. IPR2024-00009
`
`DECLARATION OF RANDALL M. ZUSMAN, M.D.
`
`DR. REDDY’S LABORATORIES, INC.
`IPR2024-00009
`Ex. 1091, p. 1 of 16
`
`

`

`TABLE OF CONTENTS
`
`I.
`
`II.
`
`III.
`
`INTRODUCTION .......................................................................................... 1
`
`BACKGROUND AND QUALIFICATIONS ................................................. 2
`
`INFORMATION RELIED UPON AND OPINIONS REGARDING
`THE ’462 PATENT ........................................................................................ 5
`
`IV. CONCLUSION ............................................................................................... 6
`
`DR. REDDY’S LABORATORIES, INC.
`IPR2024-00009
`Ex. 1091, p. 2 of 16
`
`

`

`TABLE OF EXHIBITS
`
`Description
`
`U.S. Patent No. 10,335,462
`Prosecution history excerpts for U.S. Patent No. 10,335,462
`Declaration of John Bantle, MD
`CV of John Bantle, MD
`Declaration of William J. Jusko, Ph.D.
`CV of William J. Jusko, Ph.D.
`Declaration of Paul Dalby, Ph.D.
`CV of Paul Dalby, Ph.D.
`Intentionally Left Blank
`Intentionally Left Blank
`WO 2011/138421
`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
`U.S. Patent Application Pub. No. US2007/0010424
`U.S. Patent No. 5,512,549
`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)
`Bydureon prescribing information (Jan. 2012)
`Byetta prescribing information (Oct. 2009)
`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
`
`
`
`Exhibit
`1001
`1002
`1003
`1004
`1005
`1006
`1007
`1008
`1009
`1010
`1011
`1012
`
`1013
`1014
`1015
`1016
`1017
`1018
`
`1019
`
`1020
`1021
`1022
`
`1023
`
`1024
`
`1025
`
`1026
`
`
`
`DR. REDDY’S LABORATORIES, INC.
`IPR2024-00009
`Ex. 1091, p. 3 of 16
`
`

`

`Exhibit
`
`1027
`
`1028
`
`1029
`
`1030
`
`1031
`
`1032
`
`1033
`
`1034
`1035
`
`1036
`
`1037
`
`1038
`
`1039
`
`
`
`Description
`(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)
`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)
`U.S. Patent No. 6,268,343 (“Knudsen patent”)
`Lund, Emerging GLP-1 Receptor Agonists, 16 EXPERT OP. ON
`EMERGING DRUGS 607 (2011)
`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)
`Nielsen, Pharmacology of Exenatide (Synthetic Exendin-4): A
`Potential Therapeutic for Improved Glycemic Control of Type 2
`Diabetes, 117 REGUL. PEPTIDES 77 (2004)
`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)
`Victoza, PHYSICIANS’ DESK REFERENCE (65th ed. 2010)
`
`DR. REDDY’S LABORATORIES, INC.
`IPR2024-00009
`Ex. 1091, p. 4 of 16
`
`

`

`Exhibit
`1040
`
`1041
`1042
`1043
`1044
`
`1045
`
`1046
`
`1047
`
`1048
`
`1049
`
`1050
`
`1051
`
`1052
`
`1053
`
`1054
`
`
`
`Description
`Vilsbøll, Glucagon-Like Peptide-1 and Diabetes Treatment, 21 INT’L
`DIABETES MONITOR 1 (2009)
`WO 03/002136
`WO 91/11457
`U.S. Patent App. Pub. 2004/0102486
`Rohatagi, Model-Based Development of a PPARγ Agonist,
`Rivoglitazone, to Aid Dose Selection and Optimize Clinical Trial
`Designs, 48 J. CLINICAL PHARMACOLOGY 1420 (2008)
`Shargel, APPLIED BIOPHARMACEUTICS &
`PHARMACOKINETICS (5th ed. 2005)
`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)
`Tamimi, Drug Development: From Concept to Marketing!, 113
`NEPHRON CLINICAL PRACTICE c125 (2009)
`FDA Guidance for Industry, Exposure-Response Relationships -
`Study Design, Data, Analysis, and Regulatory Applications (Apr.
`2003)
`International Conference on Harmonisation; Dose-Response
`Information to Support Drug Registration; Guideline; Availability, 59
`Fed. Reg. 55972 (Nov. 9, 1994) (“ICH 1994”)
`Garber, Efficacy of Metformin in Type II Diabetes: Results of a
`Double-Blind, Placebo-Controlled, Dose-Response Trial, 102 AM. J.
`MED. 491 (1997)
`Landersdorfer, Pharmacokinetic/Pharmacodynamic Modelling in
`Diabetes Mellitus, 47(7) CLINICAL PHARMACOKINETICS 417
`(2008)
`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)
`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
`
`DR. REDDY’S LABORATORIES, INC.
`IPR2024-00009
`Ex. 1091, p. 5 of 16
`
`

`

`Description
`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
`WO 2011/073328
`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)
`Monami, Effects of Glucagon-Like Peptide-1 Receptor Agonists on
`Body Weight: A Meta-Analysis, 2012 EXPERIMENTAL DIABETES
`RSCH. 1 (2012)
`Tasneem, The Database for Aggregate Analysis of ClinicalTrials.gov
`(AACT) and Subsequent Regrouping by Clinical Specialty, 7(3) PLOS
`ONE 1(2012)
`Knudsen, Liraglutide: The Therapeutic Promise from Animal Models,
`64(suppl 167) INT’L J. CLINICAL PRACTICE 4 (2010) (“Knudsen
`2010b”)
`U.S. Patent No. 8,536,122
`U.S. Patent No. 8,129,343
`REMINGTON: THE SCIENCE AND PRACTICE OF PHARMACY
`(Alfonso R. Gennaro ed., 20th ed. 2000)
`Boylan, Parenteral Products, in MODERN PHARMACEUTICS
`(Gilbert S. Banker et al. eds., 3d ed. 1996)
`U.S. Patent No. 6,284,727
`U.S. Patent No. 5,164,366
`
`Exhibit
`
`1055
`
`1056
`1057
`1058
`
`1059
`
`1060
`1061
`1062
`
`1063
`
`1064
`
`1065
`
`1066
`
`1067
`1068
`1069
`
`1070
`
`1071
`1072
`
`
`
`DR. REDDY’S LABORATORIES, INC.
`IPR2024-00009
`Ex. 1091, p. 6 of 16
`
`

`

`Description
`
`U.S. Patent No. 6,458,924
`WO 00/37098
`U.S. Patent No. 7,022,674
`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)
`U.S. Patent App. Pub. No. 2004/0102486
`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)
`Ozempic prescribing information (Oct. 2022)
`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
`Prosecution history excerpts for U.S. Patent No. 9,764,003
`Declaration of Dr. Russell M. Zusman
`CV of Dr. Russell M. Zusman
`Declaration of Dr. John P. Fruehauf
`CV of Dr. John P. Fruehauf
`Declaration of Dr. Maureen M. Donovan
`CV of Dr. Maureen M. Donovan
`Mylan Pharmaceuticals Inc., v. Novo Nordisk A/S, IPR2023-00724,
`Paper 10 (PTAB Oct. 4, 2023)
`
`Exhibit
`1073
`1074
`1075
`1076
`
`1077
`
`1078
`1079
`
`1080
`
`1081
`1082
`
`1083
`
`1084
`
`1085
`
`1086
`
`1087
`1091
`1092
`1093
`1094
`1095
`1096
`1097
`
`
`
`
`
`DR. REDDY’S LABORATORIES, INC.
`IPR2024-00009
`Ex. 1091, p. 7 of 16
`
`

`

`I.
`
`INTRODUCTION
`
`1.
`
`I have been retained by the law firm Winston & Strawn LLP on
`
`behalf of Dr. Reddy’s Laboratories, Ltd. and Dr. Reddy’s Laboratories, Inc.,
`
`(hereinafter, collectively, “DRL” or “Petitioners”) to provide expert opinions
`
`concerning the administration of semaglutide for the treatment of diabetes.
`
`2.
`
`I have been asked to provide my opinions related to U.S. Patent
`
`No. 10,335,462 (“the ’462 patent”) (Ex. 1001) and the scientific and technical
`
`knowledge regarding the subject matter of the ’462 patent. I understand that
`
`Mylan Pharmaceuticals Inc. (“Mylan”) filed an inter partes review petition
`
`(“Mylan’s petition”) against claims 1-10 of the ’462 patent, and the Patent Trial
`
`and Appeal Board instituted Mylan’s petition on October 4, 2023. See Ex. 1097,
`
`Mylan Pharmaceuticals Inc., v. Novo Nordisk A/S, IPR2023-00724, Paper 10
`
`(“Mylan IPR”). I understand that DRL petitions for inter partes review of the
`
`same claims of the ’462 patent as the Mylan IPR on the same grounds, and DRL
`
`requests to join the Mylan IPR. I submit this declaration in support of DRL’s
`
`petition for inter partes review.
`
`3.
`
`My opinions in this declaration are based on the documents I cite
`
`along with my professional training, experience and knowledge that I have
`
`acquired working in the field of cardiology. I am being compensated for my
`
`services as an expert at my standard consulting rate of $1,050 per hour. My
`
`
`
`DR. REDDY’S LABORATORIES, INC.
`IPR2024-00009
`Ex. 1091, p. 8 of 16
`
`

`

`compensation is in no way contingent on the substance of my opinions or the
`
`outcome of this case.
`
`II. BACKGROUND AND QUALIFICATIONS
`
`4.
`
`I obtained a Bachelor of Science degree in Chemistry with Highest
`
`Honors from the University of Michigan in 1969.
`
`5.
`
`I obtained an M.D. from Yale University School of Medicine in
`
`1973.
`
`6.
`
`Since June 2009, I have been a physician at Massachusetts General
`
`Hospital (“MGH”) in Boston, Massachusetts. Also at MGH, I was an assistant
`
`physician from January 1985 to December 1988 and an associate physician from
`
`January 1989 to December 2008. Throughout my time at MGH, my practice has
`
`focused on cardiology.
`
`7.
`
`Since 1982, I have been the Director of the Hypertension Section,
`
`Cardiology Division, Medical Services at MGH.
`
`8.
`
`I have been board-certified in Internal Medicine by the American
`
`Board of Internal Medicine since 1976. I have also been board-certified in
`
`Cardiovascular Diseases by the American Board of Internal Medicine since 1983.
`
`9.
`
`Peer-reviewed journals have published more than 45 original
`
`reports, more than 80 clinical communications, and more than 30 review articles
`
`
`
`DR. REDDY’S LABORATORIES, INC.
`IPR2024-00009
`Ex. 1091, p. 9 of 16
`
`

`

`that I authored or co-authored. I am also the author or co-author of numerous
`
`book chapters relating to cardiology, cardiovascular disease, and hypertension.
`
`10.
`
`I am an active member of several professional societies, including:
`
`the American Society of Nephrology (member since 1976); the American Heart
`
`Association (member since 1978); the American Society of Hypertension
`
`(member since 1988, clinical specialist in hypertension since 1999, and member
`
`of the association of hypertension specialists since 2009); and the American
`
`College of Cardiology (fellow since 1990).
`
`11. Since 1981, I have served on the editorial boards of numerous
`
`journals, including the Journal of Clinical Hypertension, Journal of Hypertension,
`
`Reviews in Contemporary Pharmacotherapy, and Cardiology and Therapy. I
`
`have also served as an ad hoc reviewer for journals such as the New England
`
`Journal of Medicine, Circulation, the Journal of Clinical Investigation,
`
`Hypertension, the American Journal of Hypertension, the Journal of the
`
`American College of Cardiology, the American Journal of Cardiology, the
`
`Journal of the American Society of Hypertension, Circulation Research, and the
`
`American Journal of Medicine.
`
`12. From January 2001 to June 2016, I served as a cardiology consultant
`
`for the Medical Department of the Massachusetts Institute of Technology in
`
`Cambridge, Massachusetts.
`
`
`
`DR. REDDY’S LABORATORIES, INC.
`IPR2024-00009
`Ex. 1091, p. 10 of 16
`
`

`

`13. Since June 1994, I have been an associate professor of medicine at
`
`Harvard Medical School (“HMS”) in Boston, Massachusetts. Prior to that, I
`
`served at HMS as an instructor from January 1978 to June 1980, and as an
`
`assistant professor from July 1980 to December 1993.
`
`14. My current professional activities are divided into clinical service,
`
`teaching, and administrative responsibilities, focusing primarily on the care of
`
`patients with hypertension, hyperlipidemia (hypercholesterolemia and/or
`
`hypertriglyceridemia), cardiovascular risk factors, and vascular disease. As a
`
`cardiologist specializing in the reduction of the cardiovascular risk of my patients,
`
`I am routinely involved in the treatment of hypertension, hyperlipidemia, diabetes
`
`mellitus, and obesity. The practice of cardiology has now branched into the use
`
`of drugs, previously traditionally prescribed by endocrinologists/diabetologists.
`
`In particular, I now regularly prescribe the GLP-1 agonists (for example,
`
`semaglutide), as well as the full range of other drugs that impact the body’s
`
`metabolic pathways, to facilitate the control of my patient’s HgBA1c (blood
`
`sugar), lipid profile and weight, and in so doing reduce their cardiovascular risk.
`
`My very active outpatient practice includes many patients who were intolerant of
`
`previously prescribed anti-hypertensive medications and referred to me for the
`
`development of an effective anti-hypertensive regimen, while others have marked
`
`lipid disorders which have been resistant to standard therapies and/or have been
`
`
`
`DR. REDDY’S LABORATORIES, INC.
`IPR2024-00009
`Ex. 1091, p. 11 of 16
`
`

`

`intolerant of those therapies (used to reduce their cardiovascular risk profile). I
`
`estimate that about 40% of my patients present with type 2 diabetes mellitus; of
`
`those, about 20% also present with some form of kidney disease.
`
`15. As a clinician scientist, I have participated in many landmark clinical
`
`trials that have established standard of care principles in the treatment of patients
`
`with cardiovascular disease.
`
` These contributions
`
`include
`
`the use of
`
`pharmacologic therapy as well as non-drug based strategies for the treatment of
`
`patients post-myocardial
`
`infarction with asymptomatic LV dysfunction,
`
`survivors of myocardial infarction with moderate elevations of LDL cholesterol,
`
`patients with elevated hs-CRP concentrations to reduce cardiovascular risk,
`
`cardiac arrhythmias, and newly diagnosed patients with diabetes mellitus. My
`
`most recent clinical research focused on the determination of the mechanism by
`
`which the relaxation response produces a reduction in blood pressure in
`
`hypertensive patients.
`
`16. My teaching responsibilities include formal contributions as an
`
`attending physician (Cardiology Consultation Service and Step-Down Unit
`
`Visit), classroom lectures in the HST program, and participation in multiple post-
`
`graduate CME courses at HMS, as well as a visiting professor at many hospitals
`
`and medical schools around the country. One of my most important teaching
`
`roles is as a “curbside consultant” to the medical staff, interns, residents and
`
`
`
`DR. REDDY’S LABORATORIES, INC.
`IPR2024-00009
`Ex. 1091, p. 12 of 16
`
`

`

`fellows of MGH who seek my advice on a regular basis regarding the reduction
`
`of the cardiovascular risk profile of the patients for whom they are responsible.
`
`17.
`
`I have also focused on activities that promote patient and community
`
`education. Through my many appearances on the local and national news, and
`
`the publication of the Harvard Medical School Special Health Report on
`
`Hypertension, I have contributed to the public’s understanding of this disease and
`
`helped them to make changes in their lifestyle and understand the use of their
`
`medications to reduce their cardiovascular risk. My career has involved clinical
`
`research relating to cardiovascular risk reduction (hypertension, hyperlipidemia,
`
`LV dysfunction, diabetes mellitus, atrial fibrillation), including the study of
`
`conventional approaches to blood pressure control (pharmacologic therapy) as
`
`well as complementary or alternative medical strategies (acupuncture, relaxation
`
`response). I have been involved in technological developments, study design,
`
`and, basic scientific and laboratory research that has led to a greater
`
`understanding of renal physiology and blood pressure control. The long term
`
`consequences of this effort have been a better understanding of hypertension,
`
`hyperlipidemia, and cardiovascular disease, and an improved treatment algorithm
`
`for the reduction of cardiovascular mortality and morbidity worldwide.
`
`
`
`DR. REDDY’S LABORATORIES, INC.
`IPR2024-00009
`Ex. 1091, p. 13 of 16
`
`

`

`18. Additional information regarding my background, qualifications,
`
`publications, and presentations is provided in my curriculum vitae, which is
`
`included as Ex. 1092.
`
`III.
`
`INFORMATION RELIED UPON AND OPINIONS REGARDING
`THE ’462 PATENT
`
`19.
`
`In addition to my general knowledge gained as a result of my
`
`education and experience as a medical doctor, I have reviewed and considered,
`
`among other things, the ’462 patent, the prosecution history of the ’462 patent,
`
`and the prior art of record discussed herein.
`
`20.
`
`I also reviewed the Institution Decision issued by the Board in
`
`IPR2023-00724 instituting inter partes review of the same challenged claims of
`
`the ’462 patent with respect to all grounds in Mylan’s petition. See Ex. 1097,
`
`IPR2023-00724, Institution Decision, Paper 10. I agree with the Board’s
`
`reasoning in its Institution Decision, which concerns the same claims of the same
`
`patent challenged here.
`
`21.
`
`I have also reviewed and considered the declaration of John
`
`Bantle, M.D. (Ex. 1003) submitted in connection with Mylan's petition for inter
`
`partes review of the '462 patent, including materials and exhibits cited therein.
`
`See Ex. 1003, IPR2023-00724, Mylan's Petition, Paper 1. I agree with, and
`
`hereby adopt and incorporate by reference, a l l o f the opinions set forth in the
`
`
`
`DR. REDDY’S LABORATORIES, INC.
`IPR2024-00009
`Ex. 1091, p. 14 of 16
`
`

`

`declaration of Dr. Bantle.
`
`22. Based on my view of the prior art, it is my opinion that claims 1-10
`
`of the ’462 patent are anticipated and/or would have been obvious over the
`
`following prior art references, alone or in combination:
`
`a) Ground 1: International Patent App. Pub. No. WO 2011/128421
`
`(“WO421”) (Ex. 1011) anticipated claims 1-3 of the ’462 patent;
`
`b) Ground 2: Lovshin, Incretin-Based Therapies for Type 2 Diabetes
`
`Mellitus, 5 NATURE REV. ENDOCRINOLOGY 262 (2009) (“Lovshin”)
`
`(Ex. 1012) anticipated claims 1-3 of the ’462 patent;
`
`c) Ground 3: Claims 1–10 of the ’462 patent would have been obvious over
`
`WO421 in view of U.S. Patent Application Pub. No. US2007/0010424 (the
`
`“’424 publication”) (Ex. 1016);
`
`d) Ground 4: Claims 1–10 of the ’462 patent would have been obvious over
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`International Patent App. Pub. No. WO 2006/097537 (“WO537”) (Ex.
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`1015) in view of Lovshin; and
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`e) Ground 5: Claims 1–10 of the ’462 patent would have been obvious over
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`Clinical Trial No. NCT00696657 (“NCT657”) (Ex. 1013) in view of
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`Clinical Trial No. NCT00851773 (“NCT773”) (Ex. 1014) and further in
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`view of the ’424 publication.
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`DR. REDDY’S LABORATORIES, INC.
`IPR2024-00009
`Ex. 1091, p. 15 of 16
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`

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`IV. CONCLUSION
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`23.
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`This declaration is based on my present assessment of material and
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`information currently available to me.
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`24.
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`I understand that this declaration will be filed as evidence in a
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`contested case before the Patent Trial and Appeal Board of the United States
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`Patent and Trademark Office. I also understand that I may be subject to cross-
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`examination concerning this declaration, and I will appear for cross-examination,
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`if required of me, during the time allotted for cross-examination.
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`25.
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`I hereby declare that all statements made herein of my own
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`knowledge are true and that all statements made herein on information and belief
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`are believed to be true. Further, these statements were made with the knowledge
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`that willful false statements and the like so made are punishable by fine,
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`imprisonment, or both, under Section 1001 of Title 18 of the United States Code.
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`Date: October 19, 2023
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`/Randall M. Zusman, MD/
`Randall M. Zusman, M.D.
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`DR. REDDY’S LABORATORIES, INC.
`IPR2024-00009
`Ex. 1091, p. 16 of 16
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`