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 MAUREEN D. DONOVAN, PH.D.
`
`DR. REDDY’S LABORATORIES, INC.
`IPR2024-00009
`Ex. 1095, p. 1 of 15
`
`

`

`I.
`II.
`III.
`
`TABLE OF CONTENTS
`INTRODUCTION .......................................................................................... 1
`BACKGROUND AND QUALIFICATIONS ................................................ 2
`INFORMATION RELIED UPON AND OPINIONS REGARDING
`THE ’462 PATENT........................................................................................ 5
`IV. CONCLUSION .............................................................................................. 6
`
`
`
`
`
`
`
`
`
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`
`
`
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`
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`
`
`
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`
`
`
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`
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`
`
`
`
`DR. REDDY’S LABORATORIES, INC.
`IPR2024-00009
`Ex. 1095, p. 2 of 15
`
`

`

`TABLE OF EXHIBITS
`
`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
`
`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)
`
`
`
`
`
`
`
`DR. REDDY’S LABORATORIES, INC.
`IPR2024-00009
`Ex. 1095, p. 3 of 15
`
`

`

`Description
`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)
`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)
`
`Exhibit
`1026
`
`1027
`
`1028
`
`1029
`
`1030
`
`1031
`
`1032
`
`1033
`
`1034
`1035
`
`1036
`
`1037
`
`1038
`
`
`
`DR. REDDY’S LABORATORIES, INC.
`IPR2024-00009
`Ex. 1095, p. 4 of 15
`
`

`

`Description
`Victoza, PHYSICIANS’ DESK REFERENCE (65th ed. 2010)
`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
`
`Exhibit
`1039
`1040
`
`1041
`1042
`1043
`1044
`
`1045
`
`1046
`
`1047
`
`1048
`
`1049
`
`1050
`
`1051
`
`1052
`
`1053
`
`1054
`
`
`
`DR. REDDY’S LABORATORIES, INC.
`IPR2024-00009
`Ex. 1095, p. 5 of 15
`
`

`

`Description
`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
`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. 1095, p. 6 of 15
`
`

`

`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. 1095, p. 7 of 15
`
`

`

`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 “Petitioner”) to provide expert opinions
`
`concerning the administration of semaglutide formulations 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 pharmaceutics. I am being compensated for my
`
`
`
`DR. REDDY’S LABORATORIES, INC.
`IPR2024-00009
`Ex. 1095, p. 8 of 15
`
`

`

`services as an expert at my standard consulting rate of $500 per hour. My
`
`compensation is in no way contingent on the substance of my opinions or the
`
`outcome of this case.
`
`II. BACKGROUND AND QUALIFICATIONS
`
`4.
`
`I have over 35 years of experience and training in pharmaceutics. I
`
`am currently a professor in the Department of Pharmaceutical Sciences and
`
`Experimental Therapeutics at the University of Iowa College of Pharmacy. I
`
`received my Bachelor of Science in Pharmacy in 1983 from the University of
`
`Minnesota. I received my Ph.D. in Pharmaceutics in 1989 from the University of
`
`Michigan, and I was also appointed to the faculty of the University of Iowa in
`
`1989. I was a visiting scholar in the formulation development and drug delivery
`
`departments at SmithKline Beecham in 1991. I was appointed head of the
`
`Division of Pharmaceutics and Translational Therapeutics at the University of
`
`Iowa College of Pharmacy in 2008 and remained in that position until I was
`
`named as the associate dean for undergraduate programs in 2013, a position I held
`
`until 2019.
`
`5.
`
`My research interests focus on the mechanisms of absorption across
`
`mucosal tissues and the optimization of drug formulations to enhance drug
`
`absorption. I have designed and tested numerous prototype formulations to
`
`
`
`DR. REDDY’S LABORATORIES, INC.
`IPR2024-00009
`Ex. 1095, p. 9 of 15
`
`

`

`evaluate absorption or efficacy of ophthalmic, nasal, oral, buccal, vaginal, and
`
`topical delivery systems. I have taught in the areas of preformulation,
`
`formulation, and drug delivery system design at the undergraduate, graduate, and
`
`professional
`
`levels, and I have
`
`taught approaches and
`
`techniques
`
`in
`
`pharmaceutical compounding to Doctor of Pharmacy (PharmD) students.
`
`6.
`
`I have published numerous articles, book chapters, and abstracts in
`
`the areas of pharmaceutics, drug absorption, drug delivery, and materials
`
`characterization, and I am a named co-inventor for two U.S. Patents: No.
`
`6,348,209 and No. 7,297,786.
`
`7.
`
`I am a member of several professional societies for pharmaceutical
`
`science and technology, including the American Association of Pharmaceutical
`
`Scientists where I served as the association treasurer from 1998-2000; the
`
`American Association of Colleges of Pharmacy where I served as chair of the
`
`Section of Teachers of Pharmaceutics; the American Chemical Society; and the
`
`American Society for Pharmacology and Experimental Therapeutics. I have been
`
`a member of the editorial board for Molecular Pharmaceutics and served on the
`
`Editorial Advisory Board for the Journal of Pharmaceutical Innovation. I have
`
`chaired or been a member on numerous NIH review committees/study sections.
`
`I also serve as a member of the FDA Pharmaceutical Science and Clinical
`
`
`
`DR. REDDY’S LABORATORIES, INC.
`IPR2024-00009
`Ex. 1095, p. 10 of 15
`
`

`

`Pharmacology Advisory Committee.
`
`8.
`
`I have published approximately 150 articles, book chapters,
`
`abstracts and patents in the area of pharmaceutics, drug formulation, drug
`
`absorption, drug delivery, and materials characterization.
`
`9.
`
`I have given numerous
`
`invited national and
`
`international
`
`presentations at universities and scientific conferences. I am also frequently asked
`
`to provide seminars and consulting services to both large and small
`
`pharmaceutical companies.
`
`10.
`
`I have supervised over 50 PharmD, MS, PhD, post-doctoral and
`
`visiting scholars in my laboratories. Many of my MS and PhD students are
`
`employed by both small and large pharmaceutical companies, and regulatory
`
`agencies, or they hold academic positions and are active in the development or
`
`evaluation of new drug products or delivery systems.
`
`11. My research program has been funded by the NIH, NCI, and FDA.
`
`I have also engaged
`
`in numerous
`
`joint
`
`investigations sponsored by
`
`pharmaceutical companies to assist with formulation development, absorption
`
`evaluation, and druggability assessment.
`
`12.
`
`Additional details regarding my background and qualifications,
`
`including a list of all of my publications, are described in my curriculum vitae,
`
`
`
`DR. REDDY’S LABORATORIES, INC.
`IPR2024-00009
`Ex. 1095, p. 11 of 15
`
`

`

`which is included as Ex. 1096.
`
`III.
`
`INFORMATION RELIED UPON AND OPINIONS REGARDING
`THE ’462 PATENT
`
`13.
`
`In addition to my general knowledge gained as a result of my
`
`education and experience as a pharmaceutical scientist, 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.
`
`14.
`
`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.
`
`15.
`
`I have also reviewed and considered the declaration of Paul
`
`Dalby, Ph.D. (Ex. 1007) submitted in connection with Mylan's petition for inter
`
`partes review of the '462 patent, including materials and exhibits cited therein.
`
`See Ex. 1007, 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
`
`declaration of Dr. Dalby.
`
`16. My opinions are limited to semaglutide formulations used in the
`
`
`
`DR. REDDY’S LABORATORIES, INC.
`IPR2024-00009
`Ex. 1095, p. 12 of 15
`
`

`

`treatment of diabetes, as claimed in the ’462 patent. I present my opinions from
`
`the perspective of a POSA, who is defined in Section IV of the declaration of Dr.
`
`Dalby. Ex. 1007.
`
`17.
`
`I understand that DRL’s expert Dr. Randall Zusman offers the
`
`opinions that it would have been obvious to a POSA to treat diabetes with a once-
`
`weekly, 1.0 mg semaglutide injectable formulation, as recited in the limitations
`
`of claims 1–3, containing the components recited in claims 4–10 with a
`
`reasonable expectation of success in doing so.
`
`18. Based on my view of the prior art and, for certain claims, Dr.
`
`Zusman’s additional views of the prior art, it is my opinion that the claims of the
`
`’462 patent would have been obvious over the following combinations of
`
`references:
`
`a) Claims 4–10 of the ’462 patent would have been obvious over
`
`International Patent App. Pub. No. WO 2011/128421 (“WO421”) (Ex.
`
`1011) considering U.S. Patent Application Pub. No. US2007/0010424 (the
`
`“’424 publication”) (Ex. 1016) (Ground 3) or over Clinical Trial No.
`
`NCT00696657
`
`(“NCT657”)
`
`(Ex. 1013) and Clinical Trial No.
`
`NCT00851773 (“NCT773”) (Ex. 1014) considering the ’424 publication
`
`(Ground 5); and
`
`b) Claims 4–10 of the ’462 patent would have been obvious over
`
`
`
`DR. REDDY’S LABORATORIES, INC.
`IPR2024-00009
`Ex. 1095, p. 13 of 15
`
`

`

`International Patent App. Pub. No. WO 2006/097537 (“WO537”) (Ex.
`
`1015) considering Lovshin, Incretin-Based Therapies for Type 2 Diabetes
`
`Mellitus, 5 NATURE REV. ENDOCRINOLOGY 262 (2009) (“Lovshin”)
`
`(Ex. 1012) (Ground 4).
`
`19. These references would have motivated a POSA to formulate a 1.0
`
`mg semaglutide injectable formulation containing the components recited in
`
`claims 4-10 to treat type 2 diabetes with a reasonable expectation of success doing
`
`so.
`
`IV. CONCLUSION
`
`20. This declaration is based on my present assessment of material and
`
`information currently available to me.
`
`21.
`
`I understand that this declaration will be filed as evidence in a
`
`contested case before the Patent Trial and Appeal Board of the United States
`
`Patent and Trademark Office. I also understand that I may be subject to cross-
`
`examination concerning this declaration, and I will appear for cross-examination,
`
`if required of me, during the time allotted for cross-examination.
`
`22.
`
`I hereby declare that all statements made herein of my own
`
`knowledge are true and that all statements made herein on information and belief
`
`are believed to be true. Further, these statements were made with the knowledge
`
`that willful false statements and the like so made are punishable by fine,
`
`
`
`DR. REDDY’S LABORATORIES, INC.
`IPR2024-00009
`Ex. 1095, p. 14 of 15
`
`

`

`imprisonment, or both, under Section 1001 of Title 18 of the United States Code.
`
`Date: October 14, 2023
`
`|
`Maureen D. Donovan, Ph.D.
`
`DR. REDDY’S LABORATORIES, INC.
`IPR2024-00009
`Ex. 1095, p. 15 of 15
`
`DR. REDDY’S LABORATORIES, INC.
`IPR2024-00009
`Ex. 1095, p. 15 of 15
`
`