`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`MYLAN PHARMACEUTICALS INC.,
`
`Petitioner,
`
`v.
`
`NOVO NORDISK A/S,
`
`Patent Owner.
`
`
`
`
`
`
`
`
`
`
`
`Case No. IPR2023-00724
`
`Patent No. 10,335,462
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`PETITION FOR INTER PARTES REVIEW OF
`U.S. PATENT NO. 10,335,462
`
`
`
`
`
`
`
`
`
`
`
`
`Novo Nordisk Exhibit 2002
`Dr. Reddy's Laboratories v. Novo Nordisk A/S
`IPR2024-00009
`Page 00001
`
`

`

`
`
`TABLE OF CONTENTS
`
`
`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 ........................................................................... 4
`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 .................................................................................. 10
`1.
`Disclosure ................................................................................. 10
`2.
`Prosecution History .................................................................. 11
`Claim Construction (37 C.F.R. §§ 42.100(b), 42.104(b)(3)) ............. 14
`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 ........................................................................................ 17
`Scope and Content of the Prior Art .................................................... 19
`1. WO421 ..................................................................................... 20
`2.
`Lovshin ..................................................................................... 21
`3.
`NCT657 .................................................................................... 22
`4.
`NCT773 .................................................................................... 23
`
`D.
`E.
`
`F.
`
`i
`
`Novo Nordisk Exhibit 2002
`Dr. Reddy's Laboratories v. Novo Nordisk A/S
`IPR2024-00009
`Page 00002
`
`

`

`
`
`H.
`
`5. WO537 ..................................................................................... 25
`6.
`’424 Publication ....................................................................... 25
`7.
`Prior Art Informing A POSA’s General Knowledge. .............. 26
`G. WO421 Anticipated Claims 1-3 ......................................................... 26
`1. WO421 Anticipated Claim 1 ................................................... 26
`2. WO421 Anticipated Claims 2-3............................................... 35
`3. WO421 is Enabled ................................................................... 36
`Lovshin Anticipated Claims 1-3 ........................................................ 36
`1.
`Lovshin Anticipated Claim 1 ................................................... 36
`2.
`Lovshin Anticipated Claims 2-3 .............................................. 38
`3.
`Lovshin is Enabled ................................................................... 38
`Claims 1-10 Were Obvious ................................................................ 38
`1.
`POSAs Were Motivated to Pursue the Claimed Method ........ 39
`2.
`POSAs Would have had a Reasonable Expectation of
`Success ..................................................................................... 40
`Claims 1-10 were Obvious over WO421 Considering the
`’424 Publication ....................................................................... 44
`a.
`Claim 1 ........................................................................... 44
`b.
`Claims 2-3 ...................................................................... 47
`c.
`Claims 4-10 .................................................................... 47
`Claims 1-10 were Obvious over WO537 Considering
`Lovshin ..................................................................................... 50
`a.
`Claim 1 ........................................................................... 50
`b.
`Claims 2-3 ...................................................................... 52
`a.
`Claims 4-10 .................................................................... 52
`Claims 1-10 were Obvious over NCT657, NCT773, and
`the ’424 Publication. ................................................................ 54
`a.
`Claim 1 ........................................................................... 54
`b.
`Claims 2-3 ...................................................................... 58
`c.
`Claims 4-10 .................................................................... 58
`
`5.
`
`ii
`
`I.
`
`3.
`
`4.
`
`Novo Nordisk Exhibit 2002
`Dr. Reddy's Laboratories v. Novo Nordisk A/S
`IPR2024-00009
`Page 00003
`
`

`

`
`
`J.
`
`Secondary Considerations Fail to Overcome Prima Facie
`Obviousness ........................................................................................ 58
`35 U.S.C. § 325(d) Provides No Basis to Deny Institution .......................... 59
`VI.
`VII. 35 U.S.C. § 314(a) Provides No Basis to Deny Institution .......................... 65
`VIII. Conclusion .................................................................................................... 66
`
`
`
`iii
`
`Novo Nordisk Exhibit 2002
`Dr. Reddy's Laboratories v. Novo Nordisk A/S
`IPR2024-00009
`Page 00004
`
`

`

`
`
`CASES
`
`TABLE OF AUTHORITIES
`
`
`Adobe Inc. v. RAH Color Techs., LLC,
`IPR2019-00646, 2019 WL 8106160 (PTAB Sept. 4, 2019) .............................. 62
`
`Advanced Bionics, LLC v. MED-EL Elektromedizinische Geräte GmbH,
`IPR2019-01469, 2020 WL 740292 (PTAB Feb. 13, 2020) ............................... 59
`
`Apple Inc. v. Fintiv, Inc.,
`IPR2020-00019, Paper 11 (PTAB Mar. 20, 2020) ............................................. 65
`
`Atofina v. Great Lakes Chem. Corp.,
`441 F.3d 991 (Fed. Cir. 2006) ............................................................................ 33
`
`Bristol-Myers Squibb Co. v. Ben Venue Lab’ys, Inc.,
`246 F.3d 1368 (Fed. Cir. 2001) .............................................................. 27, 30, 34
`
`Brown & Williamson Tobacco Corp. v. Philip Morris Inc.,
`229 F.3d 1120 (Fed. Cir. 2000) .......................................................................... 46
`
`Celeritas Techs., Ltd. v. Rockwell Int’l Corp.,
`150 F.3d 1354 (Fed. Cir. 1998) .......................................................................... 37
`
`Chester v. Miller,
`906 F.2d 1574 (Fed. Cir. 1990) .......................................................................... 36
`
`ClearValue, Inc. v. Pearl River Polymers, Inc.,
`668 F.3d 1340 (Fed. Cir. 2012) .................................................................... 32, 33
`
`Dayco Prods., Inc. v. Total Containment, Inc.,
`329 F.3d 1358 (Fed. Cir. 2003) .......................................................................... 30
`
`Duke Univ. v. BioMarin Pharm. Inc.,
`685 F. App’x 967 (Fed. Cir. 2017) ..................................................................... 27
`
`DyStar Textilfarben GmbH v. C.H. Patrick Co.,
`464 F.3d 1356 (Fed. Cir. 2006) .......................................................................... 44
`
`E.I. DuPont de Nemours & Co. v. Synvina C.V.,
`904 F.3d 996 (Fed. Cir. 2018) ............................................................................ 41
`
`iv
`
`Novo Nordisk Exhibit 2002
`Dr. Reddy's Laboratories v. Novo Nordisk A/S
`IPR2024-00009
`Page 00005
`
`

`

`
`Eli Lilly & Co. v. Zenith Goldline Pharms., Inc.,
`471 F.3d 1369 (Fed. Cir. 2006) .......................................................................... 26
`
`Galderma Lab’ys, L.P. v. Tolmar, Inc.,
`737 F.3d 731 (Fed. Cir. 2013) ............................................................................ 38
`
`Genentech, Inc. v. Hospira, Inc.,
`946 F.3d 1333 (Fed. Cir. 2020) .................................................................... 38, 39
`
`Grünenthal GmbH v. Antecip Bioventures II LLC,
`PGR2019-00003, 2020 WL 2203740 (PTAB May 5, 2020) .............................. 22
`
`Impax Lab’ys, Inc. v. Aventis Pharms., Inc.,
`545 F.3d 1312 (Fed. Cir. 2008) .......................................................................... 36
`
`In re Aller,
`220 F.2d 454 (CCPA 1955) ................................................................................ 45
`
`In re Antor Media Corp.,
`689 F.3d 1282 (Fed. Cir. 2012) .......................................................................... 36
`
`In re Applied Materials, Inc.,
`692 F.3d 1289 (Fed. Cir. 2012) .......................................................................... 41
`
`In re Boesch,
`617 F.2d 272 (CCPA 1980) ................................................................................ 45
`
`In re Copaxone Consol. Cases,
`906 F.3d 1013 (Fed. Cir. 2018) ........................................................ 31, 47, 52, 57
`
`In re Corkill,
`771 F.2d 1496 (Fed. Cir. 1985) .......................................................................... 46
`
`In re Geisler,
`116 F.3d 1465 (Fed. Cir. 1997) .......................................................................... 45
`
`In re Kulling,
`897 F.2d 1147 (Fed. Cir. 1990) .......................................................................... 45
`
`In re Luck,
`476 F.2d 650 (CCPA 1973) ................................................................................ 44
`
`v
`
`Novo Nordisk Exhibit 2002
`Dr. Reddy's Laboratories v. Novo Nordisk A/S
`IPR2024-00009
`Page 00006
`
`

`

`
`In re Montgomery,
`677 F.3d 1375 (Fed. Cir. 2012) .......................................................................... 35
`
`In re Ozempic (Semaglutide) Patent Litigation,
`No. 22-md-3038-CFC (D. Del.) ........................................................................... 1
`
`In re Petering,
`301 F.2d 676 (CCPA 1962) .......................................................................... 30, 34
`
`In re Peterson,
`315 F.3d 1325 (Fed. Cir. 2003) .......................................................................... 45
`
`In re Qapsule Techs., Inc.,
`759 F. App’x 975 (Fed. Cir. 2019) ..................................................................... 29
`
`Ineos USA LLC v. Berry Plastics Corp.,
`783 F.3d 865 (Fed. Cir. 2015) ...................................................................... 30, 34
`
`Invitrogen Corp. v. Biocrest Mfg., L.P.,
`327 F.3d 1364 (Fed. Cir. 2003) .......................................................................... 29
`
`Lucent Techs., Inc. v. Gateway, Inc.,
`525 F.3d 1200 (Fed. Cir. 2008) .......................................................................... 29
`
`Merck & Co. v. Biocraft Lab’ys, Inc.,
`874 F.2d 804 (Fed. Cir. 1989) ............................................................................ 46
`
`Mylan Pharms. Inc. v. Yeda Rsch. & Dev. Co.,
`IPR2015-00830, Paper 85 (PTAB Dec. 2, 2016) ............................................... 41
`
`Novo Nordisk A/S v. Sun Pharm. Indus. Ltd.,
`No. 1:22-cv-00296 (D. Del.) ................................................................................. 2
`
`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) ............................. 2
`
`Novo Nordisk Inc. v. Dr. Reddy’s Laby’s Ltd.,
`No. 1:22-cv-00298 (D. Del.) ................................................................................. 2
`
`vi
`
`Novo Nordisk Exhibit 2002
`Dr. Reddy's Laboratories v. Novo Nordisk A/S
`IPR2024-00009
`Page 00007
`
`

`

`
`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.) ................................................................................. 2
`
`Novo Nordisk Inc. v. Zydus Worldwide DMCC,
`No. 1:22-cv-00297 (D. Del.) ................................................................................. 2
`
`Perricone v. Medicis Pharm. Corp.,
`432 F.3d 1368 (Fed. Cir. 2005) .............................................................. 30, 34, 37
`
`Pfizer, Inc. v. Apotex, Inc.,
`480 F. 3d 1348 (Fed. Cir. 2007) ............................................................. 44, 45, 52
`
`Phillips v. AWH Corp.,
`415 F.3d 1303 (Fed. Cir. 2005) (en banc) .......................................................... 14
`
`Rasmusson v. SmithKline Beecham Corp.,
`413 F.3d 1318 (Fed. Cir. 2005) .................................................................... 27, 36
`
`Sand Revolution II, LLC v. Cont’l Intermodal Grp.,
`IPR2019-01393, Paper 24 (PTAB June 16, 2020) ............................................. 66
`
`Valeant Pharms. Int’l, Inc. v. Mylan Pharms. Inc.,
`955 F.3d 25 (Fed. Cir. 2020) ........................................................................ 51, 56
`
`Valve Corp. v. Ironburg Inventions Ltd.,
`8 F.4th 1364 (Fed. Cir. 2021) ............................................................................. 23
`
`ZTE (USA) Inc. v. Bell N. Rsch., LLC,
`IPR2019-01365, 2020 WL 698725 (PTAB Feb. 11, 2020) ............................... 64
`
`STATUTES
`
`35 U.S.C. § 102 .................................................................................................... 4, 12
`
`35 U.S.C. § 102(a) ................................................................................................... 20
`
`35 U.S.C. § 102(b) ................................................................................. 22, 24, 25, 26
`
`vii
`
`Novo Nordisk Exhibit 2002
`Dr. Reddy's Laboratories v. Novo Nordisk A/S
`IPR2024-00009
`Page 00008
`
`

`

`
`35 U.S.C. § 102(b) ................................................................................................... 23
`
`35 U.S.C. § 102(e) ................................................................................................... 20
`
`35 U.S.C. § 103 .......................................................................................................... 4
`
`35 U.S.C. § 103(a) ................................................................................................... 38
`
`35 U.S.C. § 112 ........................................................................................................ 12
`
`35 U.S.C. § 314(a) ............................................................................................... 5, 64
`
`35 U.S.C. § 315(a)(1) ................................................................................................. 4
`
`35 U.S.C. § 315(b) ..................................................................................................... 4
`
`35 U.S.C. § 315(e)(1) ................................................................................................. 4
`
`35 U.S.C. § 325(d) ................................................................................................... 59
`
`OTHER AUTHORITIES
`
`37 C.F.R. § 42.100(b) .............................................................................................. 14
`
`37 C.F.R. § 42.101 ..................................................................................................... 4
`
`37 C.F.R. § 42.102 ..................................................................................................... 4
`
`37 C.F.R. § 42.103 ..................................................................................................... 1
`
`37 C.F.R. § 42.104 ..................................................................................................... 3
`
`37 C.F.R. § 42.104(a) ................................................................................................. 4
`
`37 C.F.R. § 42.104(b) ................................................................................................ 4
`
`37 C.F.R. § 42.104(b)(3) .......................................................................................... 14
`
`37 C.F.R. § 42.105 ..................................................................................................... 3
`
`37 C.F.R. § 42.106 ..................................................................................................... 3
`
`37 C.F.R. § 42.106(a) ................................................................................................. 1
`
`37 C.F.R. § 42.15 ....................................................................................................... 3
`
`viii
`
`Novo Nordisk Exhibit 2002
`Dr. Reddy's Laboratories v. Novo Nordisk A/S
`IPR2024-00009
`Page 00009
`
`

`

`
`37 C.F.R. § 42.22(a) ................................................................................................... 4
`
`37 C.F.R. § 42.73(d)(1) .............................................................................................. 4
`
`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) ................................................................................................ 3
`
`MPEP § 2128(II)(E) ................................................................................................. 23
`
`
`
`ix
`
`Novo Nordisk Exhibit 2002
`Dr. Reddy's Laboratories v. Novo Nordisk A/S
`IPR2024-00009
`Page 00010
`
`

`

`
`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.
`
`
`
`EXHIBIT
`
`1001
`
`1002
`
`1003
`
`1004
`
`1005
`
`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
`
`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)
`
`x
`
`Novo Nordisk Exhibit 2002
`Dr. Reddy's Laboratories v. Novo Nordisk A/S
`IPR2024-00009
`Page 00011
`
`

`

`
`
`EXHIBIT
`
`DESCRIPTION
`
`1020
`
`Bydureon prescribing information (Jan. 2012)
`
`1021
`
`Byetta prescribing information (Oct. 2009)
`
`1022
`
`1023
`
`1024
`
`1025
`
`1026
`
`1027
`
`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)
`
`xi
`
`Novo Nordisk Exhibit 2002
`Dr. Reddy's Laboratories v. Novo Nordisk A/S
`IPR2024-00009
`Page 00012
`
`

`

`
`
`EXHIBIT
`
`DESCRIPTION
`
`1031
`
`1032
`
`1033
`
`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)
`
`1036
`
`1037
`
`1038
`
`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)
`
`1039
`
`Victoza, PHYSICIANS’ DESK REFERENCE (65th ed. 2010)
`
`1040
`
`Vilsbøll, Glucagon-Like Peptide-1 and Diabetes Treatment, 21
`INT’L DIABETES MONITOR 1 (2009)
`
`1041
`
`WO 03/002136
`
`1042
`
`WO 91/11457
`
`xii
`
`Novo Nordisk Exhibit 2002
`Dr. Reddy's Laboratories v. Novo Nordisk A/S
`IPR2024-00009
`Page 00013
`
`

`

`
`
`EXHIBIT
`
`DESCRIPTION
`
`1043
`
`U.S. Patent App. Pub. 2004/0102486
`
`1044
`
`1045
`
`1046
`
`1047
`
`1048
`
`1049
`
`1050
`
`1051
`
`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)
`
`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)
`
`xiii
`
`Novo Nordisk Exhibit 2002
`Dr. Reddy's Laboratories v. Novo Nordisk A/S
`IPR2024-00009
`Page 00014
`
`

`

`
`
`EXHIBIT
`
`DESCRIPTION
`
`1053
`
`1054
`
`1055
`
`1056
`
`1057
`
`1058
`
`1059
`
`1060
`
`1061
`
`1062
`
`1063
`
`1064
`
`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
`
`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)
`
`xiv
`
`Novo Nordisk Exhibit 2002
`Dr. Reddy's Laboratories v. Novo Nordisk A/S
`IPR2024-00009
`Page 00015
`
`

`

`
`
`EXHIBIT
`
`DESCRIPTION
`
`1065
`
`1066
`
`1067
`
`1068
`
`1069
`
`1070
`
`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)
`
`1071
`
`U.S. Patent No. 6,284,727
`
`1072
`
`1073
`
`1074
`
`U.S. Patent No. 5,164,366
`
`U.S. Patent No. 6,458,924
`
`WO 00/37098
`
`1075
`
`U.S. Patent No. 7,022,674
`
`1076
`
`1077
`
`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)
`
`1078
`
`U.S. Patent App. Pub. No. 2004/0102486
`
`1079
`
`NCT00167115, CLINICALTRIALS.GOV,
`https://www.clinicaltrials.gov/ct2/show/NCT00167115 (last visited
`Mar. 10, 2023)
`
`xv
`
`Novo Nordisk Exhibit 2002
`Dr. Reddy's Laboratories v. Novo Nordisk A/S
`IPR2024-00009
`Page 00016
`
`

`

`
`
`
`
`EXHIBIT
`
`1080
`
`DESCRIPTION
`
`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
`
`xvi
`
`Novo Nordisk Exhibit 2002
`Dr. Reddy's Laboratories v. Novo Nordisk A/S
`IPR2024-00009
`Page 00017
`
`

`

`
`
`I.
`
`INTRODUCTION
`
`Petitioner Mylan Pharmaceuticals Inc. (“Petitioner”) petitions for Inter Partes
`
`Review of claims 1-10 of U.S. Patent No. 10,335,462 (“’462 patent”) (Ex. 1001),
`
`assigned to Novo Nordisk A/S (“Patent Owner”).
`
`This Petition is filed in accordance with 37 C.F.R. § 42.106(a). Filed herewith
`
`is a power of attorney and exhibit list per § 42.10(b) and § 42.63(e). Pursuant to
`
`37 C.F.R. § 42.103, the fee set forth in § 42.15 (e) accompanies this Petition.
`
`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
`
`Petitioner are Mylan Pharmaceuticals Inc., Mylan Inc., and Viatris Inc.
`
`B. Related Matters
`
`In accordance with 37 C.F.R. § 42.8(b)(2), Petitioner is not aware of any
`
`reexamination certificates or pending prosecution concerning the ’462 patent.
`
`Petitioner is a defendant in the following consolidated litigation involving the
`
`’462 patent:
`
` 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.).
`
`1
`
`Novo Nordisk Exhibit 2002
`Dr. Reddy's Laboratories v. Novo Nordisk A/S
`IPR2024-00009
`Page 00018
`
`

`

`
`
`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.).
`
`Petitioner is 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
`Brandon M. White
`Reg No. 52,354
`Perkins Coie LLP
`700 13th Street NW, Suite 800
`Washington, DC 20005
`Phone: (202) 654-6200
`Back-Up Counsel
`Courtney M. Prochnow, Ph.D.
`Reg. No. 67,639
`Perkins Coie, LLP
`633 W. 5th St., Suite 5850
`Los Angeles, CA 90071-3537
`Phone: (310) 788-9900
`Back-Up Counsel
`
`Back-Up Counsel
`Emily J. Greb
`Reg No. 68,244
`Perkins Coie LLP
`33 East Main Street, Suite 201
`Madison, WI 53703
`Phone: (608) 663-7460
`Back-Up Counsel
`Christopher D. Jones
`Reg No. 76,472
`Perkins Coie LLP
`700 13th Street NW, Suite 800
`Washington, DC 20005
`Phone: (202) 654-6200
`Back-Up Counsel
`
`2
`
`Novo Nordisk Exhibit 2002
`Dr. Reddy's Laboratories v. Novo Nordisk A/S
`IPR2024-00009
`Page 00019
`
`

`

`
`
`Jonathan I. Tietz, Ph.D.
`Reg No. 76,753
`Perkins Coie LLP
`700 13th Street NW, Suite 800
`Washington, DC 20005
`Phone: (202) 654-6200
`
`Matthew A. Lembo
`Reg No. 75,633
`Perkins Coie LLP
`1155 Avenue of the Americas
`Floor 22
`New York, NY 10036
`Phone: (212) 262-6900
`
`D.
`
`Service Information (37 C.F.R. § 42.8(b)(4))
`
`Petitioner respectfully requests that all correspondence be directed to lead
`
`counsel and back-up counsel at the contact information provided above. Petitioner
`
`consents to electronic service by e-mail at the following email addresses:
`
`White-ptab@perkinscoie.com;
`
`Greb-ptab@perkinscoie.com;
`
`Prochnow-ptab@perkinscoie.com;
`
`Tietz-ptab@perkinscoie.com;
`
`Jones-ptab@perkinscoie.com;
`
`Lembo-ptab@perkinscoie.com; and
`
`Semaglutide-Ozempic@perkinscoie.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. Petitioner’s undersigned representative authorizes the Director
`
`3
`
`Novo Nordisk Exhibit 2002
`Dr. Reddy's Laboratories v. Novo Nor