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
`
`
`PETITION FOR INTER PARTES REVIEW OF
`U.S. Patent No. 10,335,462
`
`
`
`
`
`

`

`TABLE OF CONTENTS
`
`Page
`
`INTRODUCTION ...............................................................................1
`I.
`II. MANDATORY NOTICES ...................................................................1
`A. Real Parties-In-Interest ................................................................1
`B. Related Matters ..........................................................................1
`C.
`Identification of Counsel (37 C.F.R. § 42.8(b)(3)) ...........................2
`D.
`Service Information (37 C.F.R. § 42.8(b)(4)) ..................................3
`III. REQUIREMENTS FOR INTER PARTES REVIEW.................................3
`A. Grounds for Standing ..................................................................3
`B.
`Identification of Challenge and Statement of Precise Relief Requested
`
`4
`IV. THRESHOLD REQUIREMENT FOR INTER PARTES REVIEW .............5
`V.
`STATEMENT OF REASONS FOR THE RELIEF REQUESTED .............5
`A.
`Summary of the Argument ...........................................................5
`B.
`Level of Ordinary Skill in the Art..................................................8
`C.
`The ’462 Patent ..........................................................................9
`1.
`Disclosure.........................................................................9
`2.
`Prosecution History.......................................................... 11
`D. Claim Construction (37 C.F.R. §§ 42.100(b), 42.104(b)(3)) ............ 13
`E.
`Treating Diabetes with GLP-1 Agonists Was Well Known ............. 15
`1.
`Diabetes ......................................................................... 15
`2.
`Glp-1 Agonists Were Well Known Diabetes Treatments ....... 15
`3.
`Posas Knew Semaglutide Was Being Used In Clinical Trials . 16
`Scope and Content of the Prior Art .............................................. 19
`1. WO421........................................................................... 19
`2.
`LOVSHIN ...................................................................... 20
`3.
`NCT657 ......................................................................... 22
`4.
`NCT773 ......................................................................... 23
`5. WO537........................................................................... 24
`
`F.
`
`i
`
`

`

`I.
`
`3.
`
`4.
`
`5.
`
`H.
`
`’424 Publication .............................................................. 25
`6.
`Prior Art Informing A POSA’S General Knowledge. ............ 25
`7.
`G. WO421 Anticipated Claims 1-3 .................................................. 26
`1. WO421 Anticipated Claim 1 ............................................. 26
`2. WO421 Anticipated Claims 2-3 ......................................... 35
`3. WO421 Is Enabled ........................................................... 35
`Lovshin Anticipated Claims 1-3.................................................. 36
`1.
`Lovshin Anticipated Claim 1 ............................................. 36
`2.
`Lovshin Anticipated Claims 2-3......................................... 37
`3.
`Lovshin Is Enabled .......................................................... 37
`Claims 1-10 Were Obvious ........................................................ 38
`1.
`Posas Were Motivated To Pursue The Claimed Method ........ 38
`2.
`Posas Would Have Had A Reasonable Expectation Of Success
`...................................................................................... 39
`Claims 1-10 Were Obvious Over Wo421 Considering The ‘424
`Publication...................................................................... 43
`Claims 1-10 Were Obvious Over Wo537 Considering Lovshin
`...................................................................................... 49
`Claims 1-10 were obvious over nct657, nct773, and the ‘424
`publication. ..................................................................... 54
`Secondary Considerations Fail to Overcome Prima Facie Obviousness
`J.
`58
`
`VI. 35 U.S.C. § 325(d) PROVIDES NO BASIS TO DENY INSTITUTION ... 58
`VII. 35 U.S.C. § 314(a) PROVIDES NO BASIS TO DENY INSTITUTION ... 64
`VIII. CONCLUSION ................................................................................. 65
`
`
`
`
`
`
`ii
`
`

`

`TABLE OF AUTHORITIES
`
` Page(s)
`
`Cases
`314(a). Under Apple Inc. v. Fintiv, Inc.,
`IPR2020-00019, Paper 11 (PTAB Mar. 20, 2020)....................................... 49
`Adobe Inc. v. RAH Color Techs., LLC,
`IPR2019-00646, 2019 WL 8106160 (PTAB Sept. 4, 2019) .......................... 47
`Advanced Bionics, LLC v. MED-EL Elektromedizinische Geräte
`GmbH,
`IPR2019-01469, 2020 WL 740292 (PTAB Feb. 13, 2020) ........................... 45
`In re Aller,
`220 F.2d 454 (CCPA 1955) ..................................................................... 34
`In re Antor Media Corp.,
`689 F.3d 1282 (Fed. Cir. 2012) ................................................................ 27
`In re Applied Materials, Inc.,
`692 F.3d 1289 (Fed. Cir. 2012) ................................................................ 31
`Atofina v. Great Lakes Chemical Corp.,
`441 F.3d 991 (Fed. Cir. 2006) .................................................................. 25
`Ben Venue Lab'ys, Inc.,
`246 F.3d 1368, 1379 (Fed. Cir. 2001) ...................................... 20, 22, 23, 26
`In re Boesch,
`617 F.2d 272 (CCPA 1980) ..................................................................... 34
`Brown & Williamson Tobacco Corp. v. Philip Morris Inc.,
`229 F.3d 1120 (Fed. Cir. 2000) ................................................................ 35
`Celeritas Techs., Ltd. v. Rockwell Int’l Corp.,
`150 F.3d 1354 (Fed. Cir. 1998) ................................................................ 28
`Chester v. Miller,
`906 F.2d 1574 (Fed. Cir. 1990) ................................................................ 27
`
`iii
`
`

`

`ClearValue, Inc. v. Pearl River Polymers, Inc.,
`668 F.3d 1340 (Fed. Cir. 2012) ................................................................ 24
`ClinicalTrials.gov. Grünenthal GmbH v. Antecip Bioventures II LLC,
`PGR2019- 00003, 2020 WL 2203740 (PTAB May 5, 2020) ........................ 16
`In re Copaxone Consol. Cases,
`906 F.3d 1013 (Fed. Cir. 2018) ............................................... 23, 36, 39, 43
`In re Corkill,
`771 F.2d 1496 (Fed. Cir. 1985) ................................................................ 35
`Dayco Prods., Inc. v. Total Containment, Inc.,
`329 F.3d 1358 (Fed. Cir. 2003) ................................................................ 22
`Duke Univ. v. BioMarin Pharm. Inc.,
`685 F. App’x 967 (Fed. Cir. 2017)............................................................ 20
`DyStar Textilfarben GmbH v. C.H. Patrick Co.,
`464 F.3d 1356 (Fed. Cir. 2006) ................................................................ 34
`E.I. DuPont de Nemours & Co. v. Synvina C.V.,
`904 F.3d 996 (Fed. Cir. 2018) .................................................................. 31
`Eli Lilly & Co. v. Zenith Goldline Pharms., Inc.,
`471 F.3d 1369 (Fed. Cir. 2006) ................................................................ 19
`Galderma Lab’ys, L.P. v. Tolmar, Inc.,
`737 F.3d 731 (Fed. Cir. 2013) .................................................................. 29
`In re Geisler,
`116 F.3d 1465 (Fed. Cir. 1997) ................................................................ 34
`Genentech, Inc. v. Hospira, Inc.,
`946 F.3d 1333 (Fed. Cir. 2020) ................................................................ 29
`Impax Lab’ys, Inc. v. Aventis Pharms., Inc.,
`545 F.3d 1312 (Fed. Cir. 2008) ................................................................ 27
`Ineos USA LLC v. Berry Plastics Corp.,
`783 F.3d 865 (Fed. Cir. 2015) ............................................................ 23, 26
`
`iv
`
`

`

`Invitrogen Corp. v. Biocrest Mfg., L.P.,
`327 F.3d 1364 (Fed. Cir. 2003) .......................................................... 21, 22
`In re Kulling,
`897 F.2d 1147 (Fed. Cir. 1990) ................................................................ 34
`Lucent Techs., Inc. v. Gateway, Inc.,
`525 F.3d 1200 (Fed. Cir. 2008) ................................................................ 21
`In re Luck,
`476 F.2d 650 (CCPA 1973) ..................................................................... 34
`Merck & Co. v. Biocraft Lab’ys, Inc.,
`874 F.2d 804 (Fed. Cir. 1989) .................................................................. 35
`In re Montgomery,
`677 F.3d 1375 (Fed. Cir. 2012) ................................................................ 26
`Mylan Pharms. Inc. v. Yeda Rsch. & Dev. Co.,
`IPR2015-00830, Paper 85, 29 (PTAB Dec. 2, 2016) ................................... 31
`Novo Nordisk A/S v. Sun Pharm. Indus. Ltd.,
`No. 1:22-cv-00296 (D. Del.) ...................................................................... 1
`Novo Nordisk Inc. v. Alvogen, Inc.,
`No. 1:22-cv-00299 (D. Del.) ...................................................................... 2
`Novo Nordisk Inc. v. Aurobindo Pharma USA, Inc.,
`No. 1:22-cv- 00295 (D. Del.) (dismissed on March 28, 2022)......................... 1
`Novo Nordisk Inc. v. Dr. Reddy’s Laby’s Ltd.,
`No. 1:22-cv-00298 (D. Del.) ...................................................................... 2
`Novo Nordisk Inc. v. Mylan Pharms. Inc.,
`No. 22-cv-00023 (N.D.W. Va.) .................................................................. 1
`Novo Nordisk Inc. v. Mylan Pharms. Inc.,
`No. 22-cv-01040-CFC (D. Del.) ................................................................. 1
`Novo Nordisk Inc. v. Rio Biopharmaceuticals, Inc.,
`No. 1:22-cv- 00294 (D. Del.) ..................................................................... 1
`
`v
`
`

`

`Novo Nordisk Inc. v. Zydus Worldwide DMCC,
`No. 1:22-cv-00297 (D. Del.) ...................................................................... 1
`In re Ozempic (Semaglutide) Patent Litigation,
`No. 22-md-3038-CFC (D. Del.) ................................................................. 1
`Perricone v. Medicis Pharm. Corp.,
`432 F.3d 1368 (Fed. Cir. 2005) ..................................................... 23, 26, 28
`In re Petering,
`301 F.2d 676 (CCPA 1962) .......................................................... 22, 23, 26
`In re Peterson,
`315 F.3d 1325 (Fed. Cir. 2003) ................................................................ 34
`Pfizer, Inc. v. Apotex, Inc.,
`480 F.3d 1348 (Fed. Cir. 2007) .......................................................... 34, 39
`Phillips v. AWH Corp.,
`415 F.3d 1303 (Fed. Cir. 2005) (en banc) .................................................. 11
`In re Qapsule Techs., Inc.,
`759 F. App’x 975 (Fed. Cir. 2019)............................................................ 22
`Rasmusson v. SmithKline Beecham Corp.,
`413 F.3d 1318 (Fed. Cir. 2005) .......................................................... 20, 27
`Sand Revolution II, LLC v. Cont’l Intermodal Grp.,
`IPR2019-01393, Paper 24, 12 (PTAB June 16, 2020) .................................. 50
`Valeant Pharms. Int’l, Inc. v. Mylan Pharms,
`955 F.3d 25 (Fed. Cir. 2020) .............................................................. 39, 43
`Valve Corp. v. Ironburg Inventions Ltd.,
`8 F.4th 1364 (Fed. Cir. 2021) ................................................................... 17
`ZTE (USA) Inc. v. Bell N. Rsch., LLC,
`IPR2019-01365, 2020 WL 698725, at *4 (PTAB Feb. 11, 2020) .................. 48
`Statutes
`35 U.S.C. § 102 ........................................................................................ 3, 9
`35 U.S.C. § 102(a) ...................................................................................... 15
`
`vi
`
`

`

`35 U.S.C. § 102(b) ..................................................................... 16, 17, 18, 19
`35 U.S.C. § 102(e) ...................................................................................... 15
`35 U.S.C. § 103 ............................................................................................ 3
`35 U.S.C. § 103(a) ...................................................................................... 29
`35 U.S.C. § 112 ............................................................................................ 9
`35 U.S.C. § 314(a) .................................................................................. 4, 49
`35 U.S.C. § 315(a)(1) .................................................................................... 3
`35 U.S.C. § 315(b) ........................................................................................ 3
`35 U.S.C. § 315(e)(1) .................................................................................... 3
`35 U.S.C. § 325(D) ..................................................................................... 44
`Other Authorities
`37 C.F.R. § 42.8(b)(1) ................................................................................... 1
`37 C.F.R. § 42.8(b)(2) ................................................................................... 1
`37 C.F.R. § 42.8(b)(3) ................................................................................... 2
`37 C.F.R. § 42.8(b)(4) ................................................................................... 2
`37 C.F.R. § 42.10(b)...................................................................................... 1
`37 C.F.R. § 42.15.......................................................................................... 3
`37 C.F.R. § 42.15(e) ...................................................................................... 1
`37 C.F.R. § 42.22(a) ...................................................................................... 3
`37 C.F.R. § 42.63(e) ...................................................................................... 1
`37 C.F.R. § 42.73(d)(1) ................................................................................. 3
`37 C.F.R. § 42.100(b ................................................................................... 10
`37 C.F.R. § 42.101 ........................................................................................ 3
`
`vii
`
`

`

`37 C.F.R. § 42.102 ........................................................................................ 3
`37 CER. § 42.102. cecceececeeeeeeeaeeeeeseneaaaaeeeeeeeaeaaaeeeeeseseaaaaaneseseeeaaas 3
`37 C.F.R. § 42.103 ........................................................................................ 1
`37 CER. § 42.103..ccccccccsssecsssecsessesecsesucsssesncssuesuceesaesessesecatsucsessesneaeavseeavens 1
`37 C.F.R. § 42.104 ........................................................................................ 3
`37 CER. § 42.104...ccccccccssecsssecsessescsesucsessesuesuseeseceesassecaesecatsncsssesacaeansecavens 3
`37 C.F.R. § 42.104(a) .................................................................................... 3
`37 CER. § 42.1040) .ccccccccccscsscsessescsesucseceesncsussesecstsaesecsesucaesacsessesueasansecevens 3
`37 C.F.R. § 42.104(b) .................................................................................... 3
`37 CER. § 42.1040) .c.ccccccccscscsessescsesscsecsesucsssesecsesassusaesecatsacsessesacaneaeeeeevens 3
`37 C.F.R. § 42.104(b)(3).............................................................................. 10
`37 CER. § 42,104(0)(3)..ccccccccsssecsesessecsesecsessesucsesussveausneseseesuesteneeesevsneaneaene 10
`37 C.F.R. § 42.105 ........................................................................................ 3
`37 CER. § 42.105 ..ccccccccsssecsesscsessesecsessesssesuesessesecaesnesusaesecatsacsesavsneansavseeeene 3
`37 C.F.R. § 42.106 ........................................................................................ 3
`37 CER. § 42.106...cccccccsssessesscsessesecsesuesessesncaussesecarsuesusassecaesacsesavsneansavseeevene 3
`37 C.F.R. § 42.106(a) .................................................................................... 1
`37 CER. § 42.1062) .ccccccccccscsecsessescsessesecsesucsssesecsesaesucaesecatsaesessesneaeaceeeevens 1
`MPEP § 2128(II)(E) .................................................................................... 17
`MPEP§ 2128(II)(E)...ccsesecsessesecsesecsececsecsessesucsesecsessesucarsesseeatsueaeeseaneatseteveess 17
`
`
`
`viii
`vill
`
`

`

`TABLE OF EXHIBITS
`
`DESCRIPTION
`EXHIBIT
`U.S. Patent No. 10,335,462
`1001
`Prosecution history excerpts for U.S. Patent No. 10,335,462
`1002
`Declaration of John Bantle, MD
`1003
`CV of John Bantle, MD
`1004
`Declaration of William J. Jusko, Ph.D.
`1005
`CV of William J. Jusko, Ph.D.
`1006
`Declaration of Paul Dalby, Ph.D.
`1007
`CV of Paul Dalby, Ph.D.
`1008
`Intentionally Left Blank
`1009
`Intentionally Left Blank
`1010
`1011 WO 2011/138421
`Lovshin, Incretin-Based Therapies for Type 2 Diabetes Mellitus, 5
`1012
`NATURE REV. ENDOCRINOLOGY 262 (2009)
`
`Clinical Trial No. NCT00696657
`1013
`Clinical Trial No. NCT00851773
`1014
`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 MED. 251 (1922)
`
`ix
`
`

`

`EXHIBIT
`1019
`
`1020
`1021
`1022
`
`1023
`
`1024
`
`1025
`
`1026
`
`1027
`
`1028
`
`1029
`
`DESCRIPTION
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`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
`(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)
`
`x
`
`

`

`EXHIBIT
`1030
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`1031
`
`1032
`
`1033
`
`1034
`1035
`
`DESCRIPTION
`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)
`1036 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)
`
`1037
`
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`
`1039
`
`xi
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`

`

`EXHIBIT
`1040
`
`1045
`
`1046
`
`1047
`
`1048
`
`DESCRIPTION
`Vilsbøll, Glucagon-Like Peptide-1 and Diabetes Treatment, 21
`INT’L DIABETES MONITOR 1 (2009)
`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, 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
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`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.
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`Landersdorfer, Pharmacokinetic/Pharmacodynamic Modelling in
`Diabetes Mellitus, 47(7) CLINICAL PHARMACOKINETICS 417
`(2008)
`
`1049
`
`1050
`
`1051
`
`xii
`
`

`

`1055
`
`1054
`
`DESCRIPTION
`EXHIBIT
`1052 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)
`1053 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
`1056
`1057 WO 2011/073328
`1058
`Blonde, Comparison of Liraglutide Versus Other Incretin-Related
`Anti-Hyperglycaemic Agents, 14 (suppl. 2) DIABETES, OBESITY
`& METABOLISM 20 (2012)
`1059 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)
`1060 WO 2011/058193
`1061
`U.S. Patent App. Pub. No. 2011/0166321
`Zarin, The ClinicalTrials.gov Results Database—Update and Key
`1062
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`
`xiii
`
`

`

`EXHIBIT
`1063
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`1065
`
`1066
`
`1067
`1068
`1069
`
`DESCRIPTION
`Kirillova, Results and Outcome Reporting in ClinicalTrials.gov,
`What Makes it Happen?, 7(6) PLOS ONE 1 (2012)
`1064 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
`1071
`U.S. Patent No. 5,164,366
`1072
`U.S. Patent No. 6,458,924
`1073
`1074 WO 00/37098
`1075
`U.S. Patent No. 7,022,674
`1076
`ClinicalTrials.gov Background, CLINICALTRIALS.GOV,
`https://clinicaltrials.gov/ct2/about-site/background (last visited Mar.
`10, 2023)
`
`1070
`
`xiv
`
`

`

`EXHIBIT
`1077
`
`1080
`
`1081
`1082
`
`1083
`
`1078
`1079
`
`DESCRIPTION
`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
`1087
`1088 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
`
`1084
`
`1085
`
`1086
`
`1089
`
`1090
`
`xv
`
`

`

`DESCRIPTION
`EXHIBIT
`Declaration of Dr. Russell M. Zusman
`1091
`CV of Dr. Russell M. Zusman
`1092
`Declaration of Dr. John P. Fruehauf
`1093
`CV of Dr. John P. Fruehauf
`1094
`Declaration of Dr. Maureen M. Donovan
`1095
`CV of Dr. Maureen M. Donovan
`1096
`1097 Mylan Pharmaceuticals Inc., v. Novo Nordisk A/S, IPR2023-00724,
`Paper 10 (PTAB Oct. 4, 2023)
`
`xvi
`
`

`

`I.
`
`INTRODUCTION
`Petitioners Dr. Reddy’s Laboratories, Inc. and Dr. Reddy’s Laboratories Ltd.
`
`(“Petitioners”) petitions for Inter partes Review of claims 1-10 of U.S. Patent No.
`
`10,335,462 (Ex. 1001), assigned to Novo Nordisk A/S (“Patent Owner”).
`
`This Petition is substantively identical to Mylan’s petition filed in IPR2023-
`
`00724, except for any Petitioners-specific information provided consistent with
`
`requirements related to mandatory notices. For example, this Petition asserts the
`
`same grounds of unpatentability of the ’462 patent upon which the Patent Trial and
`
`Appeal Board already instituted review in the Mylan IPR. Accordingly, there exists
`
`a reasonable likelihood that Petitioner will prevail in demonstrating unpatentability
`
`of at least one of the Challenged Claims, and Petitioners respectfully seek to join the
`
`Mylan IPR. Moreover, this Petition is timely and proper under 35 U.S.C. § 315(c).
`
`II. MANDATORY NOTICES
`A. Real Parties-In-Interest
`In accordance with 37 C.F.R. § 42.8(b)(1), the real parties-in-interest for
`
`Petitioners are Dr. Reddy’s Laboratories, Inc. and Dr. Reddy’s Laboratories Ltd.
`
`B. Related Matters
`In accordance with 37 C.F.R. § 42.8(b)(2), Petitioners are not aware of any
`
`reexamination certificates or pending prosecution concerning the ’462 patent.
`
`Petitioners are defendants in the following consolidated litigation involving the ’462
`
`patent:
`
`1
`
`

`

`•
`
`•
`
`Novo Nordisk Inc. v. Mylan Pharms. Inc., No. 22-cv-01040-CFC (D.
`Del.);
`In re Ozempic (Semaglutide) Patent Litigation, No. 22-md-3038-CFC
`(D. Del.); and
`Novo Nordisk Inc. v. Mylan Pharms. Inc., No. 22-cv-00023 (N.D.W.
`Va.).
`In addition, the following litigations also involve the ’462 patent:
`
`•
`
`•
`
`•
`
`•
`
`Novo Nordisk Inc. v. Aurobindo Pharma USA, Inc., No. 1:22-cv-
`00295 (D. Del.) (dismissed on March 28, 2022);
`Novo Nordisk Inc. v. Rio Biopharmaceuticals, Inc., No. 1:22-cv-
`00294 (D. Del.);
`Novo Nordisk A/S v. Sun Pharm. Indus. Ltd., No. 1:22-cv-00296 (D.
`Del.);
`Novo Nordisk Inc. v. Zydus Worldwide DMCC, No. 1:22-cv-00297
`(D. Del.);
`Novo Nordisk Inc. v. Dr. Reddy’s Laby’s Ltd., No. 1:22-cv-00298 (D.
`Del.); and
`Novo Nordisk Inc. v. Alvogen, Inc., No. 1:22-cv-00299 (D. Del.).
`Petitioners are not aware of any other pending litigation, or any pending
`
`•
`
`•
`
`•
`
`proceedings in front of the Patent Trial and Appeal Board.
`
`C.
`
`Identification of Counsel (37 C.F.R. § 42.8(b)(3))
`
`
`
`Lead Counsel
`Jovial Wong
`Reg. No. 60,115
`Winston & Strawn LLP
`1901 L Street NW
`Washington, DC 20036
`T: 202-282-5867
`
`Back-up Counsel
`Scott Border
`Reg. No. 77,744
`Winston & Strawn LLC
`1901 L Street, N.W.
`Washington, D.C. 20036
`T: 202-282-5054
`
`2
`
`

`

`jwong@winston.com
`
`
`
`sborder@winston.com
`
`Sharon Lin McIntosh
`(pro hac vice to be submitted)
`Winston & Strawn LLP
`1901 L Street NW
`Washington, DC 20036
`T: (202) 282-5756
`slin@winston.com
`
`
`
`
`
`Service Information (37 C.F.R. § 42.8(b)(4))
`D.
`Petitioners respectfully request that all correspondence be directed to lead
`
`counsel and back-up counsel at the contact information provided above. Petitioners
`
`consent to electronic service by e-mail at the following email addresses:
`
`sborder@winston.com, jwong@winston.com, and slin@winston.com.
`
`III. REQUIREMENTS FOR INTER PARTES REVIEW
`This Petition complies with all statutory requirements, as well as 37 C.F.R. §§
`
`42.104, 42.105, and 42.15, and should be accorded a filing date pursuant to 37 C.F.R.
`
`§ 42.106.
`
`A. Grounds for Standing
`Pursuant to 37 C.F.R. § 42.104(a), Petitioners certify that the ’462 patent is
`
`available for inter partes review and that Petitioners are not barred or estopped from
`
`requesting inter partes review on the grounds identified herein.
`
`3
`
`

`

`B.
`
`Identification of Challenge and Statement of Precise Relief
`Requested
`Pursuant to 37 C.F.R. § 42.22(a) and 37 C.F.R. § 42.104(b), Petitioners
`
`request that the Board institute inter partes review on claims 1-10 of the ’462 patent
`
`and cancel them as unpatentable for anticipation and/or obviousness under 35 U.S.C.
`
`§§ 102 and 103:
`
`Ground Claims Basis for Unpatentability
`1
`1-3
`Anticipated by WO421
`2
`1-3
`Anticipated by Lovshin
`3
`1-10 Obvious over WO421 considering the ’424 publication
`4
`1-10 Obvious over WO537 considering Lovshin
`5
`1-10 Obvious over NCT657 and NCT773 considering the ’424
`publication
`
`Petitioners’ statement of the reasons for the relief is set forth below. In
`
`
`
`support of these grounds for unpatentability, Petitioners submit the Declarations of
`
`Drs. Bantle, Jusko, and Dalby and relies on the Exhibits identified in the
`
`concurrently filed Listing of Exhibits. Solely to preserve its right to rely on expert
`
`testimony in the event that the Mylan settles, Petitioner further relies on the
`
`accompanying Declarations of Dr. Randall M. Zusman (Ex. 1091), Dr. John P.
`
`Fruehauf (Ex. 1093), and Dr. Maureen D. Donovan (Ex. 1095), each of which adopts
`
`the opinions set forth by Drs. Bantle, Jusko, and Dalby, respectively, in connection
`
`with the Mylan IPR.
`
`4
`
`

`

`IV. THRESHOLD REQUIREMENT FOR INTER PARTES REVIEW
`A petition for IPR review must demonstrate a “reasonable likelihood that the
`
`petitioners would prevail with respect to at least 1 of the claims challenged in the
`
`petition.” 35 U.S.C. § 314(a). This Petition clears that threshold. There is a
`
`reasonable likelihood that Petitioners will prevail with respect to at least one of the
`
`challenged claims.
`
`V.
`
`STATEMENT OF REASONS FOR THE RELIEF REQUESTED
`Summary of the Argument
`A.
`Glucagon-like peptide 1 (“GLP-1”) is a well-known, naturally occurring
`
`protein hormone having 37 amino acid residues, with a short duration of action
`
`(lasting just minutes in the body before being broken down). By the 1980s,
`
`researchers had discovered GLP-1 played a significant role in moderating human
`
`blood glucose levels, but its short half-life made it impracticable as a treatment for
`
`diseases like diabetes caused by elevated blood glucose levels. But researchers also
`
`learned they could extend GLP-1’s duration of action by optimizing its structure.
`
`The first-generation analogue—liraglutide—tweaked GLP-1 so that it would
`
`remain active for hours and therefore be