Mylan Pharmaceuticals Inc. et al. vs Novo Nordisk A/S

Order: Granting PO's Motion to Expunge

Patent Owner's Motion to Expunge

Termination Decision: Post-DI Settlement

Order: Order on Motions to Expunge

Order: On Protective Orders and Motions to Seal

Apotex's Motion to Expunge

Order Denying Director Review of Institution Decision

Patent Owner's Exhibit List

Petitioner Dr. Reddy's Laboratories, Ltd.'s and Patent Owner's Joint Motion to Terminate

Petitioner Dr. Reddy's Laboratories, Ltd.'s and Patent Owner's Joint Request to Treat Settlement Agreement as Business Confidential Information

EX2666

EX2667

EX2668

Patent Owner's Request for Director Review [PUBLIC]

Patent Owner's Exhibit List

Petitioner Sun Pharmaceutical Industries Ltd.'s and Sun Pharmaceutical Industries, Inc.'s and Patent Owner's Joint Motion to Terminate

Petitioner Sun Pharmaceutical Industries Ltd.'s and Sun Pharmaceutical Industries, Inc.'s and Patent Owner's Joint Request to Treat Settlement Agreement as Business Confidential Information

EX2660

EX2661

EX2662

Patent Owner's Exhibit List

Petitioner's Apotex Inc.'s and Patent Owner's Joint Motion to Terminate

Petitioner Apotex Inc.'s and Patent Owner's Joint Request to Treat Settlement Agreement as Business Confidential Information

EX2663

EX2664

EX2665

Patent Owner's Exhibit List

Petitioner's Mylan Pharmaceuticals Inc.'s and Patent Owner's Joint Motion to Terminate

Petitioner Mylan Pharmaceuticals Inc.'s and Patent Owner's Joint Request to Treat Settlement Agreement as Business Confidential Information

EX2657

EX2658

EX2659

Order: Adjusting One-Year Pendency Due to Joinder

Ex. 3100

EXPUNGED

Motion to Seal Request for Director Review

Amended Order - Setting Oral Argument - 37 CFR 42.70

EXPUNGED

Patent Owner's Motion to Seal

Petitioner's Motion to Seal

Petitioner's Objections to PO's Demonstrative Exhibits

Exhibit 1334 - REDACTED Petioner's Demonstratives

REDACTED Petitioner's Objections to PO's Demonstrative Exhibits

Order: Conduct of the Proceeding 37 C.F.R. sec. 42.5

Patent Owner's Oral Hearing Demonstratives

Patent Owner's Submission of Unresolved Objections to Petitioner's Demonstratives

Updated List of Petitioner's Exhibits

Patent Owner's Oral Hearing Demonstratives [REDACTED]

Patent Owner's Submission of Unresolved Objections to Petitioner's Demonstratives [REDACTED]

Exhibit 1334 - SEALED Pet Demonstratives

Reply in Support of Patent Owner's Motion for Sanctions

Reply to Joined Petitioners DRL and Sun in Support of Motion for Sanctions

Reply in Support of Patent Owner’s Motion for Additional Discovery

Reply to Joined Petitioners DRL and Sun in Support of Patent Owner's Motion for Additional Discovery

Petitioners Sun and DRLs joint opposition to Patent Owners motion for sanctions

Petitioners Sun and DRLs joint Response to Patent Owner’s motion for additional discovery

Mylan's Opposition to PO's Motion for Additional Discovery

Mylan's Opposition to PO's Motion for Sanctions

Updated List of Petitioner's Exhibits

Exhibit 1326 - Defs Stipulation

Exhibit 1327 - Reply memo

Exhibit 1328 - June 20 ltr

Exhibit 1329 - July 31 ltr

Exhibit 1331 - Email

Exhibit 1332 - Draft - Proposed Sanctions Motion - IPR2023-00724

Exhibit 1333 - Notice of service

Exhibit 1330 - SEALED Defs Second Supplemental Invalidity Contentions

ORDER Setting Oral Argument

Petitioner's Objections to Patent Owner's Sur-Reply Evidence

Petitioner's Updated Power of Attorney

Petitioner's Updated Mandatory Notices

Novo Nordisk A/S's Motion to Seal

EX2554 - Transcript of July 16, 2024 Deposition of Steven Coca, M.D.

EX2555 - [UNDER SEAL] Transcript of July 19, 2024 Deposition of DeForest McDuff

EX2555 - [REDACTED] Transcript of July 19, 2024 Deposition of DeForest McDuff

EX2556 - Transcript of July 26, 2024 Deposition of Allen Spiegel, M.D.

EX2557 - Transcript of July 9, 2024 Deposition of Arthur Z. Schwartzbard, M.D.

EX2558 - [UNDER SEAL] February 26, 2010 DPComm Brief Summary Sheet (produced as NN-OZEM-004442611) (Marked As Exhibit 9 at C. Jensen Deposition)

EX2601 - T. Wilcox, A. Schwartzbard, et. al, Diabetic Agents, From Metformin to SGLT2 Inhibitors and GLP1 Receptor Agonists, JACC Focus Seminar, JACC Vol. 75 (2020) (Marked As Exhibit 2601 at Arthur Z. Schwartzbard Deposition)

EX2602 - J. Newman, A. Schwartzbard, et. al, The Changing Landscape of Dia-betes Therapy for Cardiovascular Risk Reduction, JACC State-of-the-Art Review, JACC Vol. 72 (2018) (Marked As Exhibit 2602 at Arthur Z. Schwartzbard Deposition)

EX2603 - S. Coca et. al, Role of Intensive Glucose Control in Development of Re-nal End Points in Type 2 Diabetes Mellitus, Arch. Intern. Med. Vol. 172 (2012) (Marked As Exhibit 09/2603 at Steven Coca Deposition)

EX2604 - V. Perkovic et. al., Effects of Semaglutide on Chronic Kidney Disease in Patients with Type 2 Diabetes, N. Engl. J. Med. (May 24, 2024) (Marked As Exhibit 11/2604 at Steven Coca Deposition)

EX2610 - Trackdrugs.com Homepage (Marked As Exhibit 2610 at DeForest McDuff Deposition)

Patent Owner's Sur-Reply [SEALED]

Patent Owner's Sur-Reply [PUBLIC]

Patent Owner's Motion for Sanctions

Patent Owner's Motion for Additional Discovery

EX2537 - Opening Expert Report of Dr. John Bantle Regarding Invalidity of U.S. Patent No. 10,335,462, In re: Ozempic (Semaglutide) Patent Litigation, No. 1:22-cv-03038-CFC (D. Del. Mar. 19, 2024)

EX2538 - Excerpt of Opening Expert Report of Dr. Paul Dalby Regarding Invalidity of U.S. Patent No. 10,335, 462, In re: Ozempic (Semag-lutide) Patent Litigation, No. 1:22-cv-03038-CFC (D. Del. Mar. 19, 2024)

EX2539 - Notice of Service, In re: Ozempic (Semaglutide) Patent Litigation, No. 1:22-md-03038-CFC (Dkt. 330)

EX2540 - Email Exchange Between Counsel for Petitioner and Counsel for Patent Owner Regarding Request for a Sotera Stipulation

EX2541 - Dr. Reddy’s Laboratories, Ltd.’s and Dr. Reddy’s Laboratories, Inc.’s Stipulation Concerning Invalidity Grounds, In re: Ozempic (Semaglutide) Patent Litigation, No. 1:22-cv-03038-CFC (Dkt. 334)

EX2542 - Sun Pharmaceutical Industries Ltd.’s and Sun Pharmaceutical In-dustries Inc.’s Stipulation of Invalidity Contentions, In re: Ozempic (Semaglutide) Patent Litigation, No. 1:22-cv-03038-CFC (Dkt. 333)

EX2543 - Email Exchange Between Counsel for Sun Pharmaceutical Indus-tries, Ltd. and Counsel for Patent Owner Regarding Request to File Stipulation, Sun Pharmaceutical Industries, Ltd. v. Novo Nordisk A/S, IPR2024-00107, EX2031

EX2544 - Defendants’ Notice of Deposition of Stephanie Dechiaro, In re: Ozempic (Semaglutide) Patent Litigation, No. 1:22-cv-03038-CFC (Dkt. 265)

EX2545 - Petitioners’ Motion for Joinder Under 35 U.S.C. 315(c) and 37 C.F.R. 42.22 and 42.122(b), Dr. Reddy’s Laboratories Inc. v. Novo Nordisk A/S, IPR2024-00009, Pap.3 (Oct. 20, 2023)

EX2546 - Petitioner’s Motion for Joinder Under 35 U.S.C. 315(c) and 37 C.F.R. 42.22 and 42.122(b), Sun Pharmaceutical Industries Ltd. v. Novo Nordisk A/S, IPR2024-00107, Pap.2 (Nov. 2, 2023)

EX2547 - Email Notice of Electronic Filing Corresponding to In re Ozempic (Semaglutide) Patent Litigation, No. 1:22-cv-03038-CFC (Dkt. 314)

EX2548 - Email Notice of Electronic Filing Corresponding to In re Ozempic (Semaglutide) Patent Litigation, No. 1:22-cv-03038-CFC (Dkt. 333)

EX2549 - Email Notice of Electronic Filing Corresponding to In re Ozempic (Semaglutide) Patent Litigation, No. 1:22-cv-03038-CFC (Dkt. 334)

EX2550 - Sun Pharmaceutical Industries Ltd.’s and Sun Pharmaceutical In-dustries Inc.’s Stipulation of Invalidity Contentions, In re: Ozempic (Semaglutide) Patent Litigation, No. 1:22-cv-03038-CFC (Dkt. 314)

EX2551 - Opening Expert Report of William J. Jusko, Ph.D. Regarding Inva-lidity of U.S. Patent No. 10,335,462, In re: Ozempic (Semaglutide) Patent Litigation, No. 1:22-cv-03038-CFC (D. Del. Mar. 19, 2024)

EX2552 - Transcript of July 11, 2024 Deposition of John Bantle, M.D.

EX2553 - Transcript of July 12, 2024 Deposition of William J. Jusko, Ph.D.

EX2650 - Excerpt of Reply Expert Report of Dr. John Bantle Regarding In-validity of U.S. Patent No. 10,335,462, In re: Ozempic (Semag-lutide) Patent Litigation, No. 1:22-cv-03038-CFC (D. Del. July 16, 2024)

EX2651 - Excerpt of Reply Expert Report of Dr. Paul Dalby Regarding Inva-lidity of U.S. Patent No. 10,335, 462, In re: Ozempic (Semaglutide) Patent Litigation, No. 1:22-cv-03038-CFC (D. Del. July 16, 2024)

EX2652 - Excerpt of Reply Expert Report of William J. Jusko, Ph.D. Re-garding Invalidity of U.S. Patent No. 10,335,462, In re: Ozempic (Semaglutide) Patent Litigation, No. 1:22-cv-03038-CFC (D. Del. July 16, 2024)

EX2653 - July 8, 2024 Email Thread Among Counsel for Petitioners Mylan, DRL, and Sun, and Counsel for Novo Regarding IPR2023-00724 – Service of draft proposed motion for sanctions

EX2654 - July 10, 2024 Email Thread Among Counsel for Petitioners Mylan, DRL, and Sun, and Counsel for Novo Regarding IPR2023-00724 – Service of draft proposed motion for sanctions

EX2655 - July 2, 2024 Email Thread Among Counsel for Petitioners Mylan, DRL, and Sun, and Counsel for Novo Regarding IPR2023-00724 – Service of draft proposed motion for sanctions

EX2656 - July 12, 2024 Email Thread Among Counsel for Petitioners Mylan, DRL, and Sun, and Counsel for Novo Regarding IPR2023-00724 – Service of draft proposed motion for sanctions

ORDER Conduct of the Proceeding 37 C.F.R. §§ 42.5

Patent Owner's Updated Exhibit List

EX2536 - Partial Transcript of July 22, 2024 Conference Call

Petitioner's Request for Oral Argument

Patent Owner's Request for Oral Hearing

Exhibit 1308 - Redacted McDuff Decl

Exhibit 1311 - Redacted Flint Dep

Exhibit 1312 - Redacted Jensen Dep

Exhibit 1314 - Redacted Vellturo Dep

Exhibit 1323 - Redacted NN-OZEM-004426808

Redacted Petitioner's Reply

Ex. 3004 Attorney Correspondence

Order: Revised Scheduling Order

Amended Notice of Deposition of Dr. Allen Spiegel

Notice of Deposition of Dr. John Bantle

Notice of Deposition of Steven G. Coca, D.O., M.S.

Notice of Deposition of William J. Jusko, Ph.D.

Notice of Deposition of DeForest McDuff, Ph.D.

Notice of Deposition of Arthur Z. Schwartzbard, M.D.

Notice of Deposition of Dr. Allen Spiegel

June 7, 2024 Joint Stipulation to Modify Due Dates 3, 4, 5, 6, 7 and 8

Patent Owner's Objections to Evidence

Institution decision and grant of joinder, IPR2024-00107

Exhibit 1096 - Astrup

Exhibit 1097 - Garber 2009

Exhibit 1098 - Garber 2011a

Exhibit 1099 - Garber 2011b

Exhibit 1100 - Jose

Exhibit 1101 - Ozempic Orange Book

Exhibit 1102 - Rubio-Herrera

Exhibit 1103 - Saxenda label

Exhibit 1104 - Vahl

Exhibit 1105 - Victoza Orange Book

Exhibit 1106 - Wegovy label

Exhibit 1107 - Wegovy Orange book

Exhibit 1108 - White

Exhibit 1109 - Grunberger

Exhibit 1110 - Karagiannis

Exhibit 1111 - Madsbad

Exhibit 1112 - Ostawal

Exhibit 1113 - Skrivanek

Exhibit 1114 - Buse

Exhibit 1115 - CDC Report

Exhibit 1116 - Mounjaro label

Exhibit 1117 - Disapproval

Exhibit 1118

Exhibit 1119 - Trulicity label

Exhibit 1120 - Saxenda Orange Book

Exhibit 1121 - 833 patent

Exhibit 1122 - ADA Standards 2023

Exhibit 1124 - GRADE

Exhibit 1125 - Pi-Sunyer

Exhibit 1126 - Pratley

Exhibit 1127 - CLAIM CONSTRUCTION ORDER

Exhibit 1128 - Proposed order

Exhibit 1129 - Cecil

Exhibit 1130 - Novo Nordisk Annual Report 2011

Exhibit 1131 - Form 6K 2011

Exhibit 1132 - Amori

Exhibit 1133 - 37th Orange Book

Exhibit 1134 - 39th Orange Book

Exhibit 1135 - 40th Orange Book

Exhibit 1136 - Harrisons

Exhibit 1137 - Bhansali

Exhibit 1138 - Holst 2004b

Exhibit 1139 - Lorenz

Exhibit 1140 - Goland Dep

Exhibit 1141 - Preuss

Exhibit 1142 - Radbill

Exhibit 1143 - James

Exhibit 1144 - Holz

Exhibit 1145 - Pyram

Exhibit 1146 - KDOQI_2007

Exhibit 1147 - Vollenweider

Exhibit 1148 - Yu

Exhibit 1149 - Gutzwiller

Exhibit 1150 - Park 2007

Exhibit 1151 - Liu 2010

Exhibit 1152 - Kodera

Exhibit 1153 - Edwards 2004

Exhibit 1154 - Zepbound

Exhibit 1155 - Bode

Exhibit 1156 - Jacobsen

Exhibit 1157 - Davidson

Exhibit 1158 - Novo Press Release

Exhibit 1159 - McGuire

Exhibit 1160 - Perkovic

Exhibit 1161 - Zeeuw

Exhibit 1162 - Rizzo

Exhibit 1163 - Gutzwiller

Exhibit 1164 - Kanbay

Exhibit 1165 - 41st Orange Book

Exhibit 1166 - 42nd Orange Book

Exhibit 1167 - Amend compl

Exhibit 1168 - US6899699

Exhibit 1169 - US8684969

Exhibit 1170 - Correa

Exhibit 1171 - McDuff

Exhibit 1172 - Khan

Exhibit 1173 - Gordon

Exhibit 1174 - FDA FAQ

Exhibit 1175 - FDA FAQ

Exhibit 1176 - McPhillips

Exhibit 1177 - Novo Nordisk - Annual Report 2023

Exhibit 1178 - Novo Nordisk - Annual Report 2007

Exhibit 1179 - Corr

Exhibit 1180 - David and Stewart

Exhibit 1181 - MedlinePlus - Type 2 Diabetes 2.10.23

Exhibit 1182 - Ingram

Exhibit 1183 - US7762994

Exhibit 1184

Exhibit 1185 - Track Drugs

Exhibit 1186 - Gilbert

Exhibit 1187 - US8579869

Exhibit 1188 - US9108002

Exhibit 1189 - Gilbert

Exhibit 1190 - Earnings Call

Exhibit 1191 - US9457154

Exhibit 1192 - US9132239

Exhibit 1193 - US8672898

Exhibit 1194 - US8920383

Exhibit 1195 - US9687611

Exhibit 1196 - US9616180

Exhibit 1197 - US10376652

Exhibit 1198 - US11097063

Exhibit 1199 - US9861757

Exhibit 1282 - Novo Nordisk Form 6-K (May 1, 2009)

Exhibit 1283 - Novo Nordisk 2010-2011 Pipeline

Exhibit 1284 - Marre

Exhibit 1285 - Feb. 2, 2012 Novo Nordisk Earnings Call

Exhibit 1287 - Kendall

Exhibit 1289 - Rees

Exhibit 1290 - Chatzigeorgiou

Exhibit 1291 - Rosenstock 1986

Exhibit 1292 - Holman

Exhibit 1293 - 43rd Orange Book

Exhibit 1294 - Mima

Exhibit 1295 - 032 App

Exhibit 1296 - 032 App Pros History Excerpts

Exhibit 1297 - Herrington

Exhibit 1298 - Perkovic 2019

Exhibit 1299 - Wheeler

Exhibit 1310 - Bakris Dep Tr

Exhibit 1313 - Rosenstock Dep

Exhibit 1315 - Colhoun

Exhibit 1316 - NCT058

Exhibit 1317 - NCT232

Exhibit 1318 - NCT723

Exhibit 1319 - NCT271

Exhibit 1320 - NCT657

Exhibit 1321 - Bloomberg

Exhibit 1325 - Symlin

Exhibit 1201 - US9486588

Exhibit 1202 - US11446443

Exhibit 1203 - US11311679

Exhibit 1204 - US10220155

Exhibit 1205 - US10357616

Exhibit 1206 - Wegovy label - 7.2023

Exhibit 1207 - Weintraub

Exhibit 1208 - MPEP

Exhibit 1226 - Lathief

Exhibit 1227 - Kernan

Exhibit 1228 - Bagio

Exhibit 1229 - Nystrom

Exhibit 1230 - Nikolaidis

Exhibit 1231 - Bose

Exhibit 1232 - Hirata

Exhibit 1233 - Ban

Exhibit 1234 -Noyan-Ashraf

Exhibit 1235 - Horton

Exhibit 1236 -Okerson

Exhibit 1237 - Mannucci

Exhibit 1238 - Varanasi

Exhibit 1239 -Sesti

Exhibit 1200 - US9775953

Exhibit 1240 - Mells

Exhibit 1241 - Ussher

Exhibit 1242 - Marso

Exhibit 1243 - Ratner

Exhibit 1244 - Sivertsen

Exhibit 1245 - Sokos

Exhibit 1246 - Smilowitz

Exhibit 1247 - Marso

Exhibit 1248 - Gerstein

Exhibit 1249 - Zinman

Exhibit 1250 - CANVAS

Exhibit 1251 - Astrup

Exhibit 1252 - Ravassa

Exhibit 1253 - Reiger

Exhibit 1254 - Parks

Exhibit 1255 - Bucher

Exhibit 1256 - Southwell

Exhibit 1262 - Trulicity Label (11-2022)

Exhibit 1263 - Victoza Label (7-2023)

Exhibit 1265 - Invokana Label

Exhibit 1268 - UKPDS 38

Exhibit 1272 - Diabetes Care 2010

Exhibit 1273 - FDA

Exhibit 1274 - Diabetes Prevention Program (DPP)

Exhibit 1275 - DeFronzo

Exhibit 1276 - Diabetes Care 2024

Exhibit 1217 - Rawshani

Exhibit 1218 - Fox

Exhibit 1219 - Grundy

Exhibit 1220 - Giugliano

Exhibit 1221 - Sabatine

Exhibit 1222 - Sabatine

Exhibit 1223 - Emdin

Exhibit 1224 - Arnett

Exhibit 1257 - Braunwald's

Exhibit 1258 - Blaha Transcript

Exhibit 1260 - FDA Background

Exhibit 1264 - Jardiance Label (9-23)

Exhibit 1266 - Whelton

Exhibit 1271 - Diabetes Care 2019

Exhibit 1280 - Knight 2008

Exhibit 1209 - WO2005049061A2

Exhibit 1210 - Walker

Exhibit 1211 - USRE46363

Exhibit 1212 - Rawshani

Exhibit 1213 - Gore

Exhibit 1214 - Standl

Exhibit 1215 - Orasanu

Exhibit 1216 - Hess

Exhibit 1261 - Fed Reg

Exhibit 1267 - UKPDS 33.pdf

Exhibit 1269 - King

Exhibit 1270 - UKPDS34

Exhibit 1278 - De Block

Exhibit 1279 - Califf

Exhibit 1225 - Pignone

Exhibit 1259 - FDA Guidance 2008

Petitioner's Motion to Seal

Updated List of Petitioner's Exhibits

Exhibit 1300 - Bantle Decl

Exhibit 1301 - Jusko Decl

Exhibit 1302 - Speigel Decl

Exhibit 1303 - Spiegel CV

Exhibit 1304 - Schwartzbard Decl

Exhibit 1305 - Schwartzbard CV

Exhibit 1306 - Coca Decl

Exhibit 1307 - Coca CV

Petitioner's Reply (Protective Order Material)

Exhibit 1308 - SEALED McDuff Decl

Exhibit 1311 - SEALED Flint Dep

Exhibit 1312 - SEALED Jensen Dep

Exhibit 1314 - SEALED Vellturo Dep

Exhibit 1323 - SEALED NN-OZEM-004426808

Institution decision and grant of joinder, IPR2024-00009

Certificate of Service for Corrected Exhibit 2110

EX2110 - Verges, B. and Charbonnel, B., After the LEADER trial and SUSTAIN-6, how do we explain the cardiovascular benefits of some GLP-1 receptor agonists? Diabetes Metab. 43: 2s3-2s12 (2017)

Joint Stipulation to Modify Due Dates 2, 3, 4, 5, 6, 7 and 8

Petitioner's Notice of Deposition of Dr. Julio Rosenstock

Patent Owner's Updated Exhibit List

EX2535 - Declaration of Jenny C. Wu

Petitioner's Updated Power of Attorney

Petitioner's Updated Mandatory Notices

Petitioner's Notice of Deposition of Dr. George L. Bakris

Petitioner's Notice of Deposition of Michael J. Blaha

Petitioner's Notice of Deposition of Dr. Robin S. Goland

Petitioner's Notice of Deposition of Dr. Patrick J. Sinko

Petitioner's Notice of Deposition of Dr. Christopher A. Vellturo

ORDER Granting Patent Owner’s Motions for Admission Pro Hac Vice of Jenny C. Wu and Philip S. May 37 C.F.R. § 42.10

Patent Owner's Second Supplemental Mandatory Notices

ORDER Conditionally Granting Patent Owner’s Motions for Admission Pro Hac Vice of Jenny C. Wu and Philip S. May 37 C.F.R. § 42.10

Petitioner's Notice of Deposition of Anne Flint

Petitioner's Notice of Deposition of Christine Jensen

Patent Owner's Unopposed Motion for Pro Hac Vice Admission of Jenny C. Wu

EX2533 - Declaration of Jenny C. Wu

Patent Owner's Unopposed Motion for Pro Hac Vice Admission of Philip S. May

EX2534 - Declaration of Philip S. May

Petitioner's Objections to Patent Owner's Evidence

EX2011 - Declaration of George L. Bakris, M.D.

EX2012 - Rossing, P., et al., “The rationale, design and baseline data of FLOW, a kidney outcomes trial with once-weekly semaglutide in people with type 2 diabetes and chronic kidney disease,” Nephrol Dial Transplant, Vol.38, 2041-2051 (2023)

EX2013 - Heerspink, H., et al., “Effects of Semaglutide on Albuminuria and Kidney Function in People with Overweight or Obesity With or Without Type 2 Diabetes: Exploratory Analysis from the STEP 1, 2 and 3 Trials,” Diabetes Care, Vol.46, Issue 4, 801-810 (2023)

EX2014 - Weeda, E., et al., “Medication adherence to injectable glucagon-like peptide-1 (GLP-1) receptor agonists dosed once weekly vs once daily in patients with type 2 diabetes: A meta-analysis,” Int J Clin Pract., Vol.75 (2021)

EX2015 - Shaman, A., et al., “Effect of the Glucagon-Like Peptide-1 Receptor Agonists Semaglutide and Liraglutide on Kidney Outcomes in Patients With Type 2 Diabetes: Pooled Analysis of SUSTAIN 6 and LEADER,” Circulation, Vol.145, 575-585 (2022)

EX2016 - Mehdi, S., et al., “Glucagon-like peptide-1: a multi-faceted anti-inflammatory agent,” Frontiers in Immunology, Vol. 14 (2023)

EX2017 - Novo Nordisk Company Announcement (October 10, 2023)

EX2018 - Transcript of December 29, 2023 Deposition of John Bantle, M.D.

EX2019 - Transcript of January 5, 2024 Deposition of William J. Jusko, Ph.D.

EX2020 - Transcript of January 5, 2024 Deposition of William J. Jusko, Ph.D.

EX2060 - Rosenstock, J., et al., “The Fate of Taspoglutide, a Weekly GLP-1 Receptor Agonist, Versus Twice-Daily Exenatide for Type 2 Diabetes,” Diabetes Care, Vol.36, 498-504 (March 2013)

EX2061 - Nordqvist, C., “Experimental Diabetes Drug Taspoglutide Late-Stage Trials Suspended,” available at https://www.medicalnewstoday.com/articles/200893#1 (September 13, 2010)

EX2062 - Rosenstock, J., et al., “Potential of Albiglutide, a Long-Acting GLP-1 Receptor Agonist, in Type 2 Diabetes,” Diabetes Care, Vol.32, Issue 10, 1880-1886 (October 2009)

EX2063 - OPTUMRx, “Tanzeum® (albiglutide) – Drug Discontinuation,” available at https://professionals.optumrx.com/content/dam/optum3/professional-optumrx/news/rxnews/drug-recalls-shortages/drugwithdrawal_tanzeum_2017-0801.pdf (2017)

EX2064 - Synapse, “Pegylated GLP-1 analogue (LY2428757) – (Eli Lilly & Co.),” available at https://synapse.patsnap.com/drug/482a547adeba4170ab23efa225fb966d (last updated December 27, 2023)

EX2065 - Novo Nordisk, “Annual Report 2010” (February 1, 2011)

EX2066 - Kim, K., et al., “Differences in Drug Pharmacokinetics Between East Asians and Caucasians and the Role of Genetic Polymorphisms,” J Clin Pharmacol, Vol.44, 1083-1105 (2004)

EX2067 - Evaluation and Licensing Division, Pharmaceutical and Food Safety Bureau, Ministry of Health, Labour and Welfare, “Report on the Deliberation Results,” available at https://www.pmda.go.jp/files/000153180.pdf (December 3, 2009)

EX2068 - Victoza® Prescribing Information (January 2010)

EX2069 - Ozempic® Prescribing Information (September 2023)

EX2070 - NCT03144271, “Dose Escalation of Single Subcutaneous Doses of NNC 0113-0217 to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics in Healthy Male Subjects,” available at https://clinicaltrials.gov/study/NCT03144271 (last visited December 28, 2023)

EX2071 - Claim Construction Order, In re: Ozempic (Semaglutide) Patent Litigation, MDL No. 22-MD-3038, Dkt. No. 148 (D. Del. July 25, 2023)

EX2072 - Ozempic® Prescribing Information (December 2017)

EX2073 - Novo Nordisk’s Ozempic 0.5 mg solution for injection in pre-filled pen, available at https://www.medicines.org.uk/emc/product/9750/smpc#gref (last visited January 12, 2024)

EX2074 - Ozempic® Prescribing Information (Australian Product Information) (December 2020) available at https://www.novonordisk.com.au/content/dam/nncorp/au/en/pdfs/Ozempic%20 Product%20Information%20Nov%202020.pdf (last visited January 12, 2024)

EX2075 - Madsbad, S. et al., “Improved Glycemic Control With No Weight Increase in Patients With Type 2 Diabetes After Once-Daily Treatment With the Long-Acting Glucagon-Like Peptide 1 Analog Liraglutide (NN2211),” Diabetes Care, Vol.27, Issue 6, 1335-1342 (June 2004)

EX2079 - United States Patent and Trademark Office, Consolidated Trial Practice Guide, Appendix B Default Protective Order (November 2019)

EX2080 - Dhruv Khullar, “The Year of Ozempic,” New Yorker, December 14, 2023, available at https://www.newyorker.com/culture/2023-in-review/the-year-of-ozempic (last visited January 13, 2024)

EX2082 - M.S. Capehorn et al., “Efficacy and safety of once-weekly semaglutide 1.0 mg vs once-daily liraglutide 1.2 mg as add-on to 1-3 oral antidiabetic drugs in subjects with type 2 diabetes (SUSTAIN 10), Diabetes & Metabolism 46 100-109 (2020)

EX2083 - V. Aroda et al., “Efficacy and safety of once-weekly semaglutide versus once-daily insulin glargine as add-on to metformin (with or without sulfonylureas) in insulin-naïve patients with type 2 diabetes (SUSTAIN 4): a randomized, open-label, parallel-group, multicentre, multinational, phase 3a trial,” Lancet Diabetes Endocrinol 5:355-66 (2017)

EX2084 - R. Pratley et al., “Semaglutide versus dulaglutide once weekly in patients with type 2 diabetes (SUSTAIN 7): a randomized, open-label, phase 3b trial,” Lancet Diabetes Endocrinol 6:275-86 (2018)

EX2085 - A. Ahmann et al., “Efficacy and Safety of Once-Weekly Semaglutide Versus Exenatide ER in Subjects with Type 2 Diabetes (SUSTAIN 3): A 56-Week, Open-Label, Randomized Clinical Trial,” Diabetes Care 2018;41:258-266

EX2351 - National Institute of Diabetes and Digestive Kidney Diseases, “What is Diabetes,” https://www.niddk.nih.gov/health-information/diabetes/overview/what-is-diabetes, last reviewed April 2023

EX2352 - Mayo Clinic, “Diabetes – Symptoms & causes,” https://www.mayoclinic.org/diseases-conditions/diabetes/symptoms-causes/syc-20371444, last updated Sept. 15, 2023

EX2353 - Mayo Clinic, “Hyperglycemia in diabetes – Symptoms & causes,” https://www.mayoclinic.org/diseases-conditions/hyperglycemia/symptoms-causes/syc-20373631, last updated Aug. 20, 2022

EX2354 - Centers for Disease Control and Prevention, “Gestational Diabetes,” https://www.cdc.gov/diabetes/basics/gestational.html, last reviewed Dec. 30, 2022

EX2355 - National Institute of Diabetes and Digestive Kidney Diseases, “Dictionary Definition: insulin,” https://www.niddk.nih.gov/Dictionary/I/insulin

EX2356 - Centers for Disease Control and Prevention, National Diabetes Statistics Report 2020: Estimates of Diabetes and Its Burden in the United States (2020)

EX2357 - National Institute of Diabetes and Digestive Kidney Diseases, “Type 2 Diabetes,” https://www.niddk.nih.gov/health-information/diabetes/overview/what-is-diabetes/type-2-diabetes, last reviewed May 2017

EX2358 - Mayo Clinic, “Type 2 diabetes – Diagnosis & Treatment,” https://www.mayoclinic.org/diseases-conditions/type-2-diabetes/ diagnosis-treatment/drc-20351199, last updated March 14, 2023

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EX2024 - May 22, 2009 email from Milan Zdravkovic to Christine Jensen et al (produced as NN-OZEM-004449575) [UNDER SEAL]

EX2025 - May 25, 2009 Selection of Doses for Phase 3 presentation (produced as NN-OZEM-004338784) [UNDER SEAL]

EX2026 - March 5, 2010 email exchange between Daniel Jonker and Christine Jensen (produced as NN-OZEM-004442953) [UNDER SEAL]

EX2027 - March 5, 2010 PK/PD Simulations presentation (produced as NN-OZEM-004442955) [UNDER SEAL]

EX2028 - March 17, 2010 Novo Nordisk Diabetes Pipeline Advisory Board Meeting presentation (produced as NN-OZEM-000020275) [UNDER SEAL]

EX2029 - May 25, 2010 email from Niklas Ohrner to Christine Jensen (produced as NN-OZEM-004443136) [UNDER SEAL]

EX2030 - May 28, 2010 DPComm presentation (produced as NN-OZEM-004443139) [UNDER SEAL]

EX2031 - June 9, 2010 End of Phase 2 Meeting Minutes (produced as NN-OZEM-004338845) [UNDER SEAL]

EX2032 - April 23, 2012 NN9535-3819 Key Result Meeting presentation (produced as NN-OZEM-004341616) [UNDER SEAL]

EX2033 - September 24, 2012 NN9535-3819 Clinical Trial Report (produced as NN-OZEM-000064989) [UNDER SEAL]

EX2034 - September 19, 2011 NN9535-3819 Safety Committee Meeting (produced as NN-OZEM-004435305) [UNDER SEAL]

EX2035 - September 18, 2011 email from Lisbeth Vesterg Jacobsen to Christine Jensen (produced as NN-OZEM-004435304) [UNDER SEAL]

EX2036 - NN9535-3819 CTR Workflow (produced as NN-OZEM-004437994) [UNDER SEAL]

EX2038 - March 11, 2010 email from Anne Flint to Nilas Ohrner, copying Christine Jensen (produced as NN-OZEM-004442969) [UNDER SEAL]

EX2039 - March 11, 2010 draft Semaglutide Dose selection for phase 3 presentation (produced as NN-OZEM-004442970) [UNDER SEAL]

EX2040 - November 26, 2010 draft Clinical Trial Protocol for NN9535-3819 (produced as NN-OZEM-004434630) [UNDER SEAL]

EX2041 - November 26, 2010 email from Anne Flint to Christine Jensen et al (produced as NN-OZEM-004434628) [UNDER SEAL]

EX2046 - May 20, 2010 DPComm Summary Sheet (produced as NN-OZEM-004338873) [UNDER SEAL]

EX2047 - May 28, 2010 DPComm Clipping (produced as NN-OZEM-004338872) [UNDER SEAL]

EX2048 - Drug Product Semaglutide B, 1.34 mg/ml, Description and Composition of the Drug Product [UNDER SEAL]

EX2050 - Declaration of Christine B. Jensen, Ph.D. [UNDER SEAL AND REDACTED COPIES]

EX2051 - Declaration of Anne Flint [UNDER SEAL AND REDACTED COPIES]

EX2056 - Declaration of Patrick J. Sinko, Ph.D. [UNDER SEAL AND REDACTED COPIES]

EX2300 - Declaration of Christopher A. Vellturo, Ph.D. [UNDER SEAL AND REDACTED COPIES]

EX2301 - IQVIA Data [UNDER SEAL]

EX2302 - February 27, 2020 Specifications for 2020 Ozempic® People Cover Wrap (produced as NN-OZEM-003176580) [UNDER SEAL]

EX2303

EX2304

EX2305 - September 13, 2021 internal specifications for the Ozempic® website with savings card details (produced as NN-OZEM-003242796) [UNDER SEAL]

EX2306 - January 30, 2018 Brand Strategy presentation (produced as NN-OZEM-003732069) [UNDER SEAL]

EX2307 - January 12, 2018 Ozempic ® Brand Presentation (produced as NN-OZEM-003732120) [UNDER SEAL]

EX2308 - July 6, 2018 Product Development Plan, Ozempic® NN9535 (produced as NN-OZEM-003735283) [UNDER SEAL]

EX2309 - September 18, 2018 Semaglutide NNI Evidence Generation Plan – 2018-2021/25 presentation (produced as NN-OZEM-003793796) [UNDER SEAL]

EX2310 - September 22, 2018 SC Semaglutide QW, US RWE Plan presentation (produced as NN-OZEM-003971783) [UNDER SEAL]

EX2311 - June 13, 2017 Market Access – Track 6 presentation (produced as NN-OZEM-004055726) [UNDER SEAL]

EX2312 - September 5, 2018 Novo Nordisk/Non-Insulin Market Weekly Performance Report spreadsheet (produced as NN-OZEM-004063922) [UNDER SEAL]

EX2313 - November 5, 2019 Market Overview/GLP-1 Strategy presentation (produced as NN-OZEM-004300946) [UNDER SEAL]

EX2314 - May 16, 2017 Semaglutide Ad Board Market Overview presentation (produced as NN-OZEM-004656390) [UNDER SEAL]

EX2315 - November 5, 2019 Ozempic US Launch Tracker presentation (produced as NN-OZEM-004677154) [UNDER SEAL]

EX2316 - May 6, 202 Integrated Insights Ecosystem, Wave 1 Quarterly Insights Report presentation (produced as NN-OZEM-004679316) [UNDER SEAL]

EX2317 - June 2, 2021 Integrated Insights Ecosystem, 2021 Q1 Quarterly Insights Report presentation (produced as NN-OZEM-004680250) [UNDER SEAL]

EX2318 - March 28, 2018 GfK RepInsight spreadsheet (produced as NN-OZEM-004681464) [UNDER SEAL]

EX2320 - September 12, 2018 GLP-1 ATU 3Q18, West Area Analysis presentation (produced as NN-OZEM-004684107) [UNDER SEAL]

EX2321 - September 10, 2018 GLP-1ATU 3Q18 presentation (produced as NN-OZEM-004684467) [UNDER SEAL]

EX2322 - February 17, 2021 Integrated Insights Ecosystem, Wave 4 Quarterly Insights Report presentation (produced as NN-OZEM-004687270) [UNDER SEAL]

EX2323 - February 26, 2019 Ozempic US Launch Tracker presentation (produced as NN-OZEM-004688496) [UNDER SEAL]

EX2324 - May 2017 Brand Strategy 2018 GLP-1 Franchise presentation (produced as NN-OZEM-004690786) [UNDER SEAL]

EX2325 - February 23, 2022 Quarterly Insights Report – Q4’ 2021, Diabetes Integrated Insights Ecosystem presentation (produced as NN-OZEM-004691302) [UNDER SEAL]

EX2326 - November 16, 2021 Quarterly Insights Report – Q3’ 2021, Diabetes Integrated Insights Ecosystem presentation (produced as NN-OZEM-004691816) [UNDER SEAL]

EX2327 - February 17, 2021 Integrated Insights Ecosystem, Wave 4 Quarterly Insights Report presentation (produced as NN-OZEM-004701779) [UNDER SEAL]

EX2328 - August 8, 2021 specifications for detailing material (produced as NN-OZEM-004717717) [UNDER SEAL]

EX2329 - January 4, 2021 CV Region New Year Kick-Off Meeting presentation (produced as NN-OZEM-004723449) [UNDER SEAL]

EX2330 - November 11, 2020 Integrated Insights Ecosystem, Wave 3 Quarterly Report presentation (produced as NN-OZEM-004723593) [UNDER SEAL]

EX2331 - May 6, 2020 Integrated Insights Ecosystem, Wave 1 Quarterly Report presentation (produced as NN-OZEM-004724606) [UNDER SEAL]

EX2332 - May 2017 GLP-1 Franchise Patient Segmentation, Results & Recommendations presentation (produced as NN-OZEM-004731509) [UNDER SEAL]

EX2333 - August 11, 2020 Integrated Insights Ecosystem, Wave 2 Quarterly Report presentation (produced as NN-OZEM-004741982) [UNDER SEAL]

EX2334 - January 17, 2018 Pre-POA opening presentation (produced as NN-OZEM-004751127) [UNDER SEAL]

EX2533 - Novo Nordisk seeks partners within

EX2051 - Declaration of Anne Flint, Ph. D. [REDACTED]

EX2056 - EX2056 - Declaration of Patrick Sinko, Ph.D. [REDACTED]

Patent Owner's Response [SEALED]

EX2300 - Declaration of Christopher A Vellturo, Ph.D. [REDACTED]

EX2050 - Declaration of Christine B. Jensen, M.D., Ph.D. {REDACTED]

Patent Owner's Response [REDACTED]

ORDER Conduct of the Proceeding 37 C.F.R. § 42.5

ORDER Granting Petitioner’s Motions for Pro Hac Vice Admission of Shannon M. Bloodworth, David L. Anstaett, and Bryan D. Beel 37 C.F.R. § 42.10

Patent Owner's Supplemental Mandatory Notice

ORDER Conduct of the Proceeding 37 C.F.R. § 42.5

Email from: Megan Raymond To: Trials Cc: white-ptabBeel, Bryan D. greb-ptab prochnowptab jones-ptab tietz-pta lembo-ptab; Novo-Semaglutide Subject: IPR2023-00724 Date, December 15, 2023

Motion for Pro Hac Vice Admission of Shannon M. Bloodworth

Bloodworth Declaration

Motion for Pro Hac Vice Admission of David L. Anstaett

Anstaett Declaration

Motion for Pro Hac Vice Admission of Bryan D. Beel

Beel Declaration

Updated List of Petitioner's Exhibits

Petitioner's Updated Power of Attorney

Petitioner's Updated Mandatory Notices

Notice of Deposition of John Bantle, M.D.

Notice of Deposition of William J. Jusko, Ph.D.

Notice of Deposition of Paul Dalby, Ph.D.