UNITED STATES PATENT AND TRADEMARK OFFICE
`
`_____________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`_____________________
`
`APOTEX INC.,
`Petitioner
`
`v.
`
`NOVO NORDISK A/S,
`PATENT OWNER
`_____________________
`
`CASE IPR2024-00631
`U.S. PATENT NO. 10,335,462
`ISSUED: JULY 2, 2019
`
`TITLE:
`USE OF LONG-ACTING GLP-1 PEPTIDES
`
`PETITION FOR INTER PARTES REVIEW
`
`
`
`
`
`-i-
`
`

`

`TABLE OF CONTENTS
`
`
`
`Page
`
`TABLE OF CONTENTS ........................................................................................ i
`LIST OF EXHIBITS .............................................................................................. iv
`TABLE OF AUTHORITIES ................................................................................ xi
`I.
`INTRODUCTION ......................................................................................... 1
`II. MANDATORY NOTICES ........................................................................... 2
`A.
`Real Parties-In-Interest .......................................................................... 2
`B.
`Related Matters ...................................................................................... 2
`C.
`Identification of Counsel (37 C.F.R. § 42.8(b)(3)) ............................... 3
`D.
`Service Information (37 C.F.R. § 42.8(b)(4)) ....................................... 3
`III. REQUIREMENTS FOR INTER PARTES REVIEW .............................. 4
`A. Grounds for Standing ............................................................................ 4
`B.
`Identification of Challenge and Statement of Precise Relief
`Requested .............................................................................................. 4
`IV. STATEMENT OF REASONS FOR THE RELIEF REQUESTED ......... 5
`A.
`Summary of the Argument .................................................................... 5
`B.
`Level of Ordinary Skill in the Art ......................................................... 9
`C.
`The ’462 Patent ...................................................................................10
`1.
`Disclosure ..................................................................................10
`2.
`Prosecution History ...................................................................12
`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
`
`D.
`E.
`
`
`
`
`
`-i-
`
`

`

`F.
`
`H.
`
`I.
`
`Scope and Content of the Prior Art .....................................................19
`1. WO421 ......................................................................................20
`2.
`Lovshin ......................................................................................21
`3.
`NCT657 .....................................................................................22
`4.
`NCT773 .....................................................................................23
`5. WO537 ......................................................................................24
`6.
`’424 Publication ........................................................................25
`7.
`Prior Art Informing a POSA’s General Knowledge .................25
`G. WO421 Anticipated Claims 1-3 ..........................................................26
`1. WO421 Anticipated Claim 1 ....................................................26
`a.
`The Preamble ..................................................................26
`b.
`Comprising Administering Semaglutide ........................27
`c.
`Once Weekly in an Amount of 1.0 mg ...........................29
`d.
`To a Subject in Need Thereof .........................................34
`2. WO421 Anticipated Claims 2-3................................................35
`3. WO421 Is Enabled ....................................................................36
`Lovshin Anticipated Claims 1-3 .........................................................37
`1.
`Lovshin Anticipated Claim 1 ....................................................37
`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 .......................................................................48
`
`3.
`
`
`
`-ii-
`
`

`

`4.
`
`5.
`
`c.
`Claims 4-10 .....................................................................48
`Claims 1–10 Were Obvious over WO537 Considering
`Lovshin ......................................................................................50
`a.
`Claim 1 ............................................................................50
`b.
`Claims 2-3 .......................................................................53
`c.
`Claims 4-10 .....................................................................53
`Claims 1-10 Were Obvious over NCT657, NCT773, and the
`’424 Publication ........................................................................55
`a.
`Claim 1 ............................................................................55
`b.
`Claims 2-3 .......................................................................58
`c.
`Claims 4-10 .....................................................................58
`Secondary Considerations Fail to Overcome Prima Facie
`Obviousness .........................................................................................59
`35 U.S.C. § 325(d) PROVIDES NO BASIS TO DENY
`INSTITUTION .............................................................................................59
`35 U.S.C. § 314(a) PROVIDES NO BASIS TO DENY
`INSTITUTION .............................................................................................65
`A.
`Fintiv Does Not Warrant Denial of Institution ...................................65
`B.
`General Plastic Does Not Warrant Denial of Institution ....................66
`VII. CONCLUSION ............................................................................................68
`CERTIFICATION UNDER 37 C.F.R. §42.24(d) ...............................................69
`CERTIFICATE OF SERVICE ............................................................................70
`
`
`J.
`
`V.
`
`VI.
`
`
`
`
`
`
`
`-iii-
`
`

`

`LIST OF EXHIBITS
`1001 U.S. Patent No. 10,335,462
`1002 Prosecution history excerpts for U.S. Patent No. 10,335,462
`1003 Declaration of John Bantle, MD
`1004 CV of John Bantle, MD
`1005 Declaration of William J. Jusko, Ph.D.
`1006 CV of William J. Jusko, Ph.D.
`1007 Declaration of Paul Dalby, Ph.D.
`1008 CV of Paul Dalby, Ph.D.
`1009 Intentionally Left Blank
`1010 Intentionally Left Blank
`1011 WO 2011/138421 (“WO421”)
`1012 Lovshin, Incretin-Based Therapies for Type 2 Diabetes Mellitus, 5
`NATURE REV. ENDOCRINOLOGY 262 (2009) (“Lovshin”)
`1013 Clinical Trial No. NCT00696657 (“NCT657”)
`1014 Clinical Trial No. NCT00851773 (“NCT773”)
`1015 WO 2006/097537 (“WO537”)
`1016 U.S. Patent Application Pub. No. US2007/0010424 (the “’424 publication”)
`1017 U.S. Patent No. 5,512,549
`1018 Banting, The Internal Secretion of the Pancreas, 7 J. LAB. CLINICAL
`MED. 251 (1922)
`1019 Bell, Hamster Preproglucagon Contains the Sequence of Glucagon and Two
`Related Peptides, 302 NATURE 716 (1983)
`1020 Bydureon prescribing information (Jan. 2012)
`
`
`
`-iv-
`
`

`

`1021 Byetta prescribing information (Oct. 2009)
`1022 Drab, Incretin-Based Therapies for Type 2 Diabetes Mellitus: Current Status
`and Future Prospects, 30 PHARMACOTHERAPY 609 (2010)
`1023 Drucker, Enhancing Incretin Action for the Treatment of Type 2 Diabetes,
`26 DIABETES CARE 2929 (2003)
`1024 Drucker, The Incretin System: Glucagon-Like Peptide-1 Receptor Agonists
`and Dipeptidyl Peptidase-4 Inhibitors in Type 2 Diabetes, 368 LANCET
`1696 (2006)
`1025 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)
`1026 HARRISON’S PRINCIPLES OF INTERNAL MED., Chapter 338 (Fauci et
`al. eds. 17th ed. 2008)
`1027 Holst, Truncated Glucagon-like Peptide I, an Insulin-Releasing Hormone
`from the Distal Gut, 211 (2) FEBS LETTERS 169 (1987)
`1028 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)
`1029 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)
`1030 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)
`1031 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)
`1032 Knudsen, Glucagon-like Peptide-1: The Basis of a New Class of Treatment
`for Type 2 Diabetes, 47 J. MED. CHEMISTRY 4128 (2004)
`
`
`
`-v-
`
`

`

`1033 Knudsen, Liraglutide, a GLP­1 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 GLP­1 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)
`1037 Nielsen, Pharmacology of Exenatide (Synthetic Exendin-4): A Potential
`Therapeutic for Improved Glycemic Control of Type 2 Diabetes, 117
`REGUL. PEPTIDES 77 (2004)
`1038 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, Glucagon­Like Peptide­1 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)
`1045 Shargel, APPLIED BIOPHARMACEUTICS & PHARMACOKINETICS
`(5th ed. 2005)
`1046 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)
`
`
`
`-vi-
`
`

`

`1047 Tamimi, Drug Development: From Concept to Marketing!, 113 NEPHRON
`CLINICAL PRACTICE c125 (2009)
`1048 FDA Guidance for Industry, Exposure-Response Relationships -Study
`Design, Data, Analysis, and Regulatory Applications (Apr. 2003)
`1049 International Conference on Harmonisation; Dose-Response Information to
`Support Drug Registration; Guideline; Availability, 59 Fed. Reg. 55972
`(Nov. 9, 1994) (“ICH 1994”)
`1050 Garber, Efficacy of Metformin in Type II Diabetes: Results of a Double-
`Blind, Placebo-Controlled, Dose-Response Trial, 102 AM. J. MED. 491
`(1997)
`1051 Landersdorfer, Pharmacokinetic/Pharmacodynamic Modelling in Diabetes
`Mellitus, 47(7) CLINICAL PHARMACOKINETICS 417 (2008)
`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)
`1054 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”)
`1055 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”)
`1056 U.S. Patent No. 5,118,666
`1057 WO 2011/073328
`1058 Blonde, Comparison of Liraglutide Versus Other Incretin-Related Anti-
`Hyperglycaemic Agents, 14 (suppl. 2) DIABETES, OBESITY &
`METABOLISM 20 (2012)
`
`
`
`-vii-
`
`

`

`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
`1062 Zarin, The ClinicalTrials.gov Results Database—Update and Key Issues,
`364 NEW ENGL. J. MED. 852 (2011)
`1063 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)
`1065 Tasneem, The Database for Aggregate Analysis of ClinicalTrials.gov
`(AACT) and Subsequent Regrouping by Clinical Specialty, 7(3) PLOS ONE
`1(2012)
`1066 Knudsen, Liraglutide: The Therapeutic Promise from Animal Models,
`64(suppl 167) INT’L J. CLINICAL PRACTICE 4 (2010) (“Knudsen
`2010b”)
`1067 U.S. Patent No. 8,536,122
`1068 U.S. Patent No. 8,129,343
`1069 REMINGTON: THE SCIENCE AND PRACTICE OF PHARMACY
`(Alfonso R. Gennaro ed., 20th ed. 2000)
`1070 Boylan, Parenteral Products, in MODERN PHARMACEUTICS (Gilbert S.
`Banker et al. eds., 3d ed. 1996)
`1071 U.S. Patent No. 6,284,727
`1072 U.S. Patent No. 5,164,366
`1073 U.S. Patent No. 6,458,924
`1074 WO 00/37098
`
`
`
`-viii-
`
`

`

`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)
`1077 Award: ClinicalTrials.gov, https://ash.harvard.edu/news/clinicaltrialsgov
`(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)
`1080 NCT01933490, CLINICALTRIALS.GOV,
`https://www.clinicaltrials.gov/ct2/show/NCT01933490 (last visited Mar. 10,
`2023)
`1081 Ozempic prescribing information (Oct. 2022)
`1082 Scheduling Order, Novo Nordisk Inc. v. Rio Biopharmaceuticals Inc., No.
`22-294 (CFC) (D. Del. June 30, 2022), ECF No. 22
`1083 Transfer Order, In re: Ozempic (Semaglutide) Patent Litigation, No. 3038
`(MDL Aug. 5, 2022)
`1084 EMA, ICH Topic S 7 A Safety Pharmacology Studies for Human
`Pharmaceuticals (June 2001)
`1085 ACS Publications, https://pubs.acs.org/toc/jmcmar/47/17;
`https://pubs.acs.org/doi/10.1021/jm030630m
`1086 “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
`**Exhibit Numbers from 1088 to 1500 Have Been Intentionally Omitted**
`
`1501 Declaration of Judith Korner, M.D., Ph.D.
`1502 CV of Judith Korner, M.D., Ph.D.
`
`
`
`-ix-
`
`

`

`1503 Declaration of Mark J. Ratain, M.D.
`1504 CV of Mark J. Ratain, M.D.
`1505 Declaration of Hugh David Charles Smyth, Ph.D.
`1506 CV of Hugh David Charles Smyth, Ph.D.
`1507 Declaration of Robert Shapiro
`
`
`
`
`
`-x-
`
`

`

`TABLE OF AUTHORITIES
`
`Page
`
`Cases
`Adobe Inc. v. RAH Color Techs., LLC,
`IPR2019-00646, 2019 WL 8106160 (PTAB Sept. 4, 2019) ................................63
`Advanced Bionics, LLC v. MED­EL Elektromedizinische Geräte GmbH,
`IPR2019-01469, 2020 WL 740292 (PTAB Feb. 13, 2020) .......................... 60, 61
`Amazon.com, Inc. v. Jawbone Innovations, LLC,
`IPR2023-00284, Paper No. 12 (PTAB May 15, 2023) ........................................66
`Apple Inc. v. Fintiv, Inc.,
`IPR2020-00019, Paper No. 11 (PTAB Mar. 20, 2020) ........................................65
`Atofina v. Great Lakes Chemical Corp.,
`441 F.3d 991 (Fed. Cir. 2006) ..............................................................................33
`Becton, Dickinson & Co. v. B. Braun Melsungen AG,
`IPR2017-01586, Paper No. 8 (P.T.A.B. Dec. 15, 2017) ......................................60
`Bristol­Myers 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) ............................................................................45
`
`
`
`-xi-
`
`

`

`E.I. DuPont de Nemours & Co. v. Synvina C.V.,
`904 F.3d 996 (Fed. Cir. 2018) ..............................................................................41
`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) ..............................................................................39
`Gen. Plastic Indus. Co. v. Canon Kabushiki Kaisha,
`IPR2016-01357, Paper No. 19 (PTAB Sept. 6, 2017) ............................ 66, 67, 68
`Genentech, Inc. v. Hospira, Inc.,
`946 F.3d 1333 (Fed. Cir. 2020) ............................................................................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, 58
`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) ..................................................................................45
`In re Montgomery,
`677 F.3d 1375 (Fed. Cir. 2012) ............................................................................35
`
`
`
`-xii-
`
`

`

`In re Ozempic (Semaglutide) Patent Litigation,
`No. 22-md-3038-CFC (D. Del) .............................................................................. 2
`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
`Kingston Tech. Co., Inc. v. Securewave Storage Solutions, Inc.,
`IPR2020-00139, Paper No. 12 (PTAB Mar. 23, 2020) ........................................67
`LG Elecs., Inc. v. Gesture Tech. Partners, LLC,
`IPR2022-00092, Paper No. 8 (PTAB May 9, 2022) ............................................66
`Lucent Techs., Inc. v. Gateway, Inc.,
`525 F.3d 1200 (Fed. Cir. 2008) ............................................................................29
`Medichem, S.A. v. Rolabo, S.L,
`353 F.3d 928 (Fed. Cir. 2003) ....................................................................... 29, 47
`Merck & Co. v. Biocraft Lab’ys, Inc.,
`874 F.2d 804 (Fed. Cir. 1989) ..............................................................................46
`Mylan Pharms Inc. v. Novo Nordisk A/S,
`IPR2023-00724, Paper No. 10 (PTAB Oct. 4, 2023) ............................................. 1
`Mylan Pharms. Inc. v. Yeda Rsch. & Dev. Co.,
`IPR2015-00830, Paper No. 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.) .................................................................................. 3
`Novo Nordisk Inc. v. Aurobindo Pharma USA, Inc.,
`No. 1:22-cv-00295 (D. Del.) .................................................................................. 2
`Novo Nordisk Inc. v. Dr. Reddy’s Laby’s Ltd.,
`No. 1:22-cv-00298 (D. Del.) .................................................................................. 3
`
`
`
`-xiii-
`
`

`

`Novo Nordisk Inc. v. Mylan Pharms. Inc.,
`No. 22-cv-00023 (N.D.W. Va.) .............................................................................. 2
`Novo Nordisk Inc. v. Mylan Pharms. Inc.,
`No. 22-cv-01040-CFC (D. Del.) ............................................................................ 2
`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) ..................................................................... 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
`Shenzen Apaltek Co., Ltd., v. Astek Danmark A/S,
`IPR2022-01318, Paper No. 7 (PTAB Feb. 6, 2023) ............................................68
`Valeant Pharms. Int’l, Inc. v. Mylan Pharms. Inc.,
`955 F.3d 25 (Fed. Cir. 2020) ......................................................................... 51, 57
`Valve Corp. v. Ironburg Inventions Ltd.,
`8 F.4th 1364 (Fed. Cir. 2021) ...............................................................................22
`ZTE (USA) Inc. v. Bell N. Rsch., LLC,
`IPR2019-01365, 2020 WL 698725 (PTAB Feb. 11, 2020) .................................64
`
`
`Statutes
`35 U.S.C. § 102 ................................................................................................ passim
`35 U.S.C. § 103 ....................................................................................................4, 38
`35 U.S.C. § 112 ........................................................................................................12
`35 U.S.C. § 314 ........................................................................................................65
`35 U.S.C. § 325 ........................................................................................................59
`
`
`
`-xiv-
`
`

`

`
`Other Authorities
`81 Fed. Reg. 24,702–03 (April 27, 2016) ................................................................69
`MPEP § 2128 ...........................................................................................................22
`
`Regulations
`37 C.F.R. § 42.102 ..................................................................................................... 4
`37 C.F.R. § 42.103 ..................................................................................................... 1
`37 C.F.R. § 42.104 ...............................................................................................4, 14
`37 C.F.R. § 42.105 ...............................................................................................4, 14
`37 C.F.R. § 42.106 ..................................................................................................... 1
`37 C.F.R. § 42.15 ...................................................................................................1, 4
`37 C.F.R. § 42.22 ....................................................................................................... 4
`37 C.F.R. § 42.8 .............................................................................................. 2, 3, 69
`37 C.F.R. §42.24 ......................................................................................................69
`
`
`
`
`-xv-
`
`

`

`I.
`
`INTRODUCTION
`Petitioner Apotex Inc. (“Apotex”) petitions for inter partes review (IPR) 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 37 C.F.R. § 42.15(e)
`
`accompanies this petition.
`
`This petition is substantively identical to Mylan’s petition filed in IPR2023-
`
`00724, except for arguments made with respect to discretionary denial under 35
`
`U.S.C. § 314(a). For example, this Petition asserts the same unpatentability
`
`grounds of the ’462 patent upon which the Patent Trial and Appeal Board already
`
`instituted review in the Mylan IPR. Mylan Pharms. Inc. v. Novo Nordisk A/S,
`
`IPR2023-00724, Paper No. 10 (PTAB Oct. 4, 2023). Accordingly, there exists a
`
`reasonable likelihood that Apotex will prevail in demonstrating unpatentability of
`
`at least one of the challenged claims, and Apotex respectfully seeks to join the
`
`Mylan IPR, or alternatively, have this IPR proceeding consolidated with Mylan’s
`
`IPR proceeding.
`
`
`
`-1-
`
`

`

`II. MANDATORY NOTICES
`A. Real Parties-In-Interest
`In accordance with 37 C.F.R. § 42.8(b)(1), Petitioner Apotex Inc. is a real
`
`party-in-interest. Additional real parties-in interest are SK Artemis Holdings II,
`
`LLC, Apotex Corp., Apotex Pharmaceutical Holdings Inc., Artemis Parent, Inc.,
`
`Artemis Intermediate Holdings, Inc., and Aposherm Delaware Holdings Corp.
`
`B. Related Matters
`In accordance with 37 C.F.R. § 42.8(b)(2), Apotex is not aware of any
`
`reexamination certificates or pending prosecution concerning the ’462 patent.
`
`Apotex is aware of 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);
`● Novo Nordisk Inc. v. Mylan Pharms. Inc., No. 22-cv-00023 (N.D.W.
`Va.);
`● 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.) (transferred to MDL on August 5, 2022);
`● Novo Nordisk Inc. v. Zydus Worldwide DMCC, No. 1:22-cv-00297 (D.
`Del.);
`
`
`
`-2-
`
`

`

`● 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.)
`(dismissed on January 10, 2024).
`Apotex is not aware of any other pending litigation, or any pending proceedings in
`
`front of the Patent Trial and Appeal Board except for Mylan Pharmaceuticals Inc.
`
`v. Novo Nordisk A/S, Case No. IPR2023-00724, Dr. Reddy’s Laboratories, Inc. v.
`
`Novo Nordisk A/S, Case No. IPR2024-00009, and Sun Pharmaceutical Industries
`
`Ltd. and Sun Pharmaceutical Industries, Inc. v. Novo Nordisk A/S, Case No.
`
`IPR2024-00107.
`
`C.
`
`Identification of Counsel (37 C.F.R. § 42.8(b)(3))
`Lead counsel:
`
`John J. Molenda (Reg. No. 47,804)
`Back-up counsel:
`Lawrence Kass (Reg. No. 40,671)
`Back-up counsel:
`Tyler Doh (Reg. No. 80,274)
`Back-up counsel:
`Michael I. Green (Reg. No. 80,436)
`
`Service Information (37 C.F.R. § 42.8(b)(4))
`D.
`Apotex identifies the following:
`
`
`
`Email address:
`Mailing address:
`
`
`
`
`Semaglutide@Steptoe.com
`STEPTOE LLP
`1114 Avenue of the Americas
`New York, NY 10026
`
`212-506-3900
`212-506-3950
`
`
`
`
`Telephone number:
`Fax number:
`
`
`Please address all correspondence to the above email address. Apotex consents to
`
`
`
`
`
`
`
`electronic service at that address.
`
`
`
`-3-
`
`

`

`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. Apotex’s undersigned representative authorizes the Director
`
`to charge any required fees not submitted with this Petition to Deposit Account
`
`19-4293.
`
`A. Grounds for Standing
`Pursuant to 37 C.F.R. § 42.104(a), Apotex certifies that the ’462 patent is
`
`available for IPR and that it is not barred or estopped from requesting IPR on the
`
`grounds identified herein. Apotex meets all requirements under 35 U.S.C. §§
`
`315(a)(1), 315(b), 315(c), and 315(e)(1), and under 37 C.F.R. §§ 42.73(d)(1),
`
`42.101, and 42.102.
`
`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), Apotex requests
`
`that the Board institute IPR 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:
`
`
`
`-4-
`
`

`

`Ground
`1
`2
`
`3
`
`4
`
`5
`
`Claims
`1-3
`1-3
`1-10
`
`1-10
`
`1-10
`
`Basis for Unpatentability
`Anticipated by WO421
`Anticipated by Lovshin
`Obvious over WO421 considering the ’424
`publication
`Obvious over WO537 considering Lovshin
`Obvious over NCT657 and NCT773 considering
`the ’424 publication
`
`Apotex’s statement of the reasons for the relief is set forth below. In support
`
`
`
`of these grounds for unpatentability, Apotex submits the Declarations of Drs.
`
`Bantle, Jusko, and Dalby and relies on the exhibits identified in List of Exhibits,
`
`above. To preserve its right to rely on expert testimony in the event that the Mylan
`
`IPR settles, Apotex further r