`
`IPR2023-00724
`U.S. Patent 10,335,462
`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 IPR2023-00724
`Patent 10,335,462
`______________________
`
`PATENT OWNER’S UPDATED EXHIBIT LIST FOR
`INTER PARTES REVIEW OF U.S. PATENT NO. 10,335,462
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`IPR2023-00724
`U.S. Patent 10,335,462
`
`Exhibit Description
`EX2001 U.S. Patent No. 9,764,003 File History
`EX2002 U.S. Patent No. 9,764,003
`EX2003 Excerpt of Amended Joint Claim Construction Chart, In re: Ozempic
`(Semaglutide) Patent Litigation, No. 1:22-cv-01040-CFC, Dkt. 101 (D.
`Del. May 23, 2023)
`EX2004 Miller, M., et al., “Low Viscosity Highly Concentrated Injectable
`Nonaqueous Suspensions of Lysozyme Microparticles,” Langmuir, Author
`Manuscript (2011), PMC 2011 (Feb 17)
`EX2005 Knight, A., “Systematic Reviews of Animal Experiments Demonstrate
`Poor Contributions Toward Human Healthcare,” Reviews on Recent
`Clinical Trials, Vol.3, Issue 2, 89-96 (2008)
`EX2006 Arrowsmith, J., “Phase II failures: 2008–2010,” Nature Reviews, Drug
`Discovery, Vol. 10 (May 2011)
`EX2007 Excerpt of Novo Nordisk’s Initial Responses to Defendants’ Initial
`Invalidity Contentions Regarding U.S. Patent Nos. 8,129,343; 8,536,122;
`8,114,833; 8,920,383; 9,775,953; 9,457,154; and 10,335,462, In re:
`Ozempic (Semaglutide) Patent Litigation, No. 1:22-cv-01040-CFC, (D.
`Del. Dec. 21, 2022)
`EX2008 Ozempic®, Prescribing Information (October 2022)
`EX2009 Declaration of Sayem Osman
`EX2010 Declaration of Julio Rosenstock, M.D.
`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)
`
`

`

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`IPR2023-00724
`U.S. Patent 10,335,462
`
`Exhibit Description
`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 World Trade Organization: Members and Observers, available at
`https://www.wto.org/english/thewto_e/whatis_e/tif_e/org6_e.htm (last
`visited January 15, 2024)
`EX2021 Drug Product: Semaglutide C solution for injection, syringe,
`Pharmaceutical Development (produced as NN-OZEM-000158851)
`[UNDER SEAL]
`EX2022 April 22, 2009 NN9535-1821 Key Results Meeting Presentation (produced
`as NN-OZEM-004470861) [UNDER SEAL]
`EX2023 April 22, 2009 email from Lise Brondsted to Christine Jensen et al
`(produced as NN-OZEM-004470860) [UNDER SEAL]
`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]
`
`

`

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`IPR2023-00724
`U.S. Patent 10,335,462
`
`Exhibit Description
`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]
`EX2037 --intentionally omitted--
`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]
`EX2042 --intentionally omitted--
`EX2043 --intentionally omitted--
`EX2044 --intentionally omitted--
`EX2045 --intentionally omitted--
`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]
`EX2049 Declaration of Devraj Chakravarty
`EX2050 Declaration of Christine B. Jensen, Ph.D. [UNDER SEAL AND
`REDACTED COPIES]
`EX2051 Declaration of Anne Flint [UNDER SEAL AND REDACTED COPIES]
`EX2052 Declaration of Chloe Jiang
`EX2053 Declaration of Smita Agarwal
`EX2054 Declaration of Robin S. Goland, M.D.
`EX2055 Declaration of Michael J. Blaha, M.D.
`EX2056 Declaration of Patrick J. Sinko, Ph.D. [UNDER SEAL AND REDACTED
`COPIES]
`EX2057 Declaration of Jenna DiCicco
`EX2058 Declaration of Sayem Osman
`EX2059 Declaration of Vanessa Costain
`
`

`

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`IPR2023-00724
`U.S. Patent 10,335,462
`
`Exhibit Description
`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)
`
`

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`IPR2023-00724
`U.S. Patent 10,335,462
`
`Exhibit Description
`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)
`EX2076 Ozempic® Prescribing Information (March 2022)
`EX2077 Mueller, C., “University of South Carolina Upstate, CHEM U109
`Chemistry of Living Things,” 9.1:Solutions, available at
`https://chem.libretexts.org/Courses/University_of_South_Carolina__Upsta
`te/
`USC_Upstate%3A_CHEM_U109_-
`_Chemistry_of_Living_Things_(Mueller)/09%3A_Solutions/9.1%3A_Sol
`utions (last visited January 16, 2024)
`EX2078 Blüher, M. et al., “Dose-response effects on HbA1c and bodyweight
`reduction of survodutide, a dual glucagon/GLP-1 receptor agonist,
`compared with placebo and open-label semaglutide in people with type 2
`diabetes: a randomized clinical trial,” Diabetologia (2023), available at
`https://link.springer.com/content/pdf/10.1007/s00125-023-06053-9.pdf
`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)
`EX2081 Dani Blum, “What’s Next for Ozempic,” New York Times, December 20,
`2023
`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)
`
`

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`IPR2023-00724
`U.S. Patent 10,335,462
`
`Exhibit Description
`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
`EX2086 Abdul-Ghani, M., et al., Cardiovascular Disease and Type 2 Diabetes: Has
`the Dawn of a New Era Arrived?, Diabetes Care, 40:813-820 (2017).
`EX2087 ADA Standards of Medical Care., Cardiovascular Disease and Risk
`Management: Standards of Medical Care in Diabetes, Diabetes Care
`45(Suppl. 1):S144–S175 (2022)
`EX2088 American College of Cardiology, “Clinical Topics, Diabetes and
`Cardiometabolic Disease,” https://www.acc.org/Clinical-Topics/Diabetes-
`and-Cardiometabolic-Disease (last visited Jan. 16, 2024).
`EX2089 American Society for Preventive Cardiology, “Cardiometabolic
`Fellowship,” https://www.aspconline.org/professional-
`development/cardiometabolic-fellowship/ (last visited Jan. 16, 2024).
`EX2090 Cosentino, F. et al., ESC Guidelines on diabetes, pre-diabetes, and
`cardiovascular diseases developed in collaboration with the EASD, Eur.
`Heart J., 41:255-323 (2019)
`EX2091 Das, S.R., et al., ACC Expert Consensus Decision Pathway on Novel
`Therapies for Cardiovascular Risk Reduction in Patients with Type 2
`Diabetes and Atherosclerotic Cardiovascular Disease, J. Am. Coll.
`Cardiol., 72: 3200-3223 (2018)
`EX2092 Das, S.R., et al., Expert Consensus Decision Pathway on Novel Therapies
`for Cardiovascular Risk Reduction in Patients with Type 2 Diabetes, J.
`Am. Coll. Cardiol., 76: 1117-1145 (2020)
`EX2093 Davies, M.J, et al., Cardiovascular outcomes trials: a paradigm shift in the
`current management of type 2 diabetes, Cardiovasc. Diabetol., 21:144
`(2022)
`
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`IPR2023-00724
`U.S. Patent 10,335,462
`
`Exhibit Description
`EX2094 Eckel, R.H. and Blaha, M.J., Cardiometabolic Medicine: A Call for a New
`Subspecialty Training Track in Internal Medicine, Am. J. Med.,
`132(7):788-790 (2019).
`EX2095 Evans, L.M., et al., A population-adjusted indirect comparison of
`cardiovascular benefits of once-weekly subcutaneous semaglutide and
`dulaglutide in the treatment of patients with type 2 diabetes, with or
`without established cardiovascular disease, Endocrinol. Diab. Metab.
`2021;4:e00259 (2021)
`EX2096 --intentionally omitted--
`EX2097 García-Casares, N., et al., Effects of GLP-1 receptor agonists on
`neurological complications of diabetes, Rev. Endocr. Metab. Disord.,
`24:655-672 (2023)
`EX2098 Jha, K.K., et al., Transitioning to GLP-1 RAs and SGLT2 Inhibitors as the
`First Choice for Managing Cardiometabolic Risk in Type 2 Diabetes, Curr.
`Atheroscler. Rep., 24:925-937 (2022)
`EX2099 Kleindorfer, D.O., et al., Guideline for the Prevention of Stroke in Patients
`With Stroke and Transient Ischemic Attack, Stroke, 52:e364–e467 (2021)
`EX2100 Leiter, L.A., et al., Cardiovascular risk reduction with once weekly
`semaglutide in subjects with type 2 diabetes: a post hoc analysis of gender,
`age, and baseline CV risk profile in the SUSTAIN 6 trial, Cardiovasc.
`Diabetol., 18:73 (2019)
`EX2101 Marso, S.P., et al., Semaglutide and Cardiovascular Outcomes in Patients
`with Type 2 Diabetes, N. Engl. J. Med., 375:1834-1844 (2016)
`EX2102 Marso, S.P., et al., Supplementary Appendix to Semaglutide and
`Cardiovascular Outcomes in Patients with Type 2 Diabetes, N. Engl. J.
`Med., 375:1834-1844 (2016)
`EX2103 Marx, N., et al., GLP-1 Receptor Agonists for the Reduction of
`Atherosclerotic Cardiovascular Risk in Patients with Type 2 Diabetes,
`Circulation, 146:1882-1894 (2022)
`EX2104 Maskery, M.P., et al., Glucagon-like peptide-1 receptor agonists as
`neuroprotective agents for ischemic stroke: a systematic scoping review, J.
`Cereb. Blood Flow Metab., 41:14-30 (2020)
`EX2105 Nauck, M.A., et al., Cardiovascular Actions and Clinical Outcomes With
`Glucagon-Like Peptide-1 Receptor Agonists and Dipeptidyl Peptidase-4
`Inhibitors, Circulation, 186: 849-870 (2017)
`EX2106 Ozempic® FDA Approval Letter (Dec. 15, 2017)
`EX2107 Ozempic® FDA Approval Letter for sNDA (March 28, 2022)
`
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`IPR2023-00724
`U.S. Patent 10,335,462
`
`Exhibit Description
`EX2108 Reiter-Brennan, C., Comprehensive Care Models for Cardiometabolic
`Disease, Curr. Cardiol. Rep., 23(3):22 (2021).
`EX2109 Sattar, N., et al., Novel Diabetes Drugs and the Cardiovascular Specialist,
`J. Am. Coll. Cardiol., 69: 2646-2656 (2017)
`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)
`EX2111 Verma, S., et al., Effects of glucagon-like peptide-1 receptor agonists
`liraglutide and semaglutide on cardiovascular and renal outcomes across
`body mass index categories in type 2 diabetes: Results of the LEADER
`and SUSTAIN 6 trials, Diabetes Obes. Metab., 22:2487-2492 (2020)
`EX2112 Terry, T., et al., Does aggressive glycemic control benefit macrovascular
`and microvascular disease in type 2 diabetes? Insights from ACCORD,
`ADVANCE, and VADT, Curr. Cardiol. Rep., 14(1):79-88 (2012).
`EX2113 Victoza® FDA Approval Letter (Jan. 25, 2010)
`EX2114
`--intentionally omitted--
`to
`EX2299
`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 March 3, 2020 Specifications for the “Music Man Digital Exam Room
`Poster” (produced as NN-OZEM-003176957) [UNDER SEAL]
`EX2304 July 30, 2021 internal specifications for the Ozempic® website with
`savings card details (produced as NN-OZEM-003238568) [UNDER
`SEAL]
`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]
`
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`IPR2023-00724
`U.S. Patent 10,335,462
`
`Exhibit Description
`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]
`EX2319 --intentionally omitted--
`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]
`
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`IPR2023-00724
`U.S. Patent 10,335,462
`
`Exhibit Description
`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]
`--intentionally omitted--
`
`EX2335
`to
`EX2350
`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.
`
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`IPR2023-00724
`U.S. Patent 10,335,462
`
`Exhibit Description
`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.
`EX2359 Moses, R.G., Combination Therapy for Patients with Type 2 Diabetes:
`Repaglinide in Combination with Metformin, Overview of Oral
`Antidiabetic Medications,
`https://www.medscape.com/viewarticle/722513_3
`EX2360 Quianzon, C. C.L. and Cheick, I.E., History of current non-insulin
`medications for diabetes mellitus, J. Community Hosp. Intern. Med.
`Perspect. 2012 Oct. 15; 2(3). Doi: 10.3402/jchimp.v2i3.19081.
`EX2361 National Institute of Diabetes and Digestive and Kidney Diseases, “Low
`Blood Glucose (Hypoglycemia),” https://www.niddk.nih.gov/health-
`information/diabetes/overview/preventing-problems/low-blood-glucose-
`hypoglycemia, last reviewed July 2021.
`EX2362 U.S. Food & Drug Administration, Drugs@FDA, Diabeta®
`EX2363 U.S. Food & Drug Administration, Drugs@FDA, Micronase®
`EX2364 U.S. Food & Drug Administration, Drugs@FDA, Glucotrol®
`EX2365 U.S. Food & Drug Administration, Drugs@FDA, Amaryl®
`EX2366 Cleveland Clinic, “Biguanides,”
`https://my.clevelandclinic.org/health/treatments/25004-biguanides, last
`reviewed May 22, 2023.
`EX2367 Sirtori, C.R. and Pasik, C., Re-evaluation of a biguanide, metformin:
`mechanism of action and tolerability, Pharmacol. Res. 1994 Oct-Nov;
`30(3):187-228.
`EX2368 Tomkin, G.H., Treatment of type 2 diabetes, lifestyle, GLP1 agonists and
`DPP4 inhibitors, World J. Diabetes, 2014 Oct. 15; 5(5):636-650.
`
`

`

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`IPR2023-00724
`U.S. Patent 10,335,462
`
`Exhibit Description
`EX2369 U.S. Food & Drug Administration, Drugs@FDA, Glucophage®
`EX2370 White, Jr., J.R., A Brief History of the Development of Diabetes
`Medications, Diabetes Spectr. 2014;27(2):82-86.
`EX2371 U.S. Food & Drug Administration, Drugs@FDA, Prandin®
`EX2372 Eggleton, J.S. and Jialal, I., Thiazolidinediones, StatPearls [Internet],
`available at https://www.ncbi.nlm.nih.gov/books/NBK551656/, last
`updated Feb. 20, 2023.
`EX2373 Cleveland Clinic, “GLP-1 Agonists,”
`https://my.clevelandclinic.org/health/treatments/13901-glp-1-agonists, last
`reviewed July 3, 2023.
`EX2374 Tran, K.L., et al., Overview of Glucagon-Like Peptide-1 Receptor
`Agonists for the Treatment of Patients with Type 2 Diabetes, Am. Health
`Drug Benefits 2017 Jun; 10(4):178-188.
`EX2375 U.S. Food & Drug Administration, Approval Letter for Januvia® (Oct. 16,
`2006)
`EX2376 Kalra, S., Sodium Glucose Co-Transporter-2 (SGLT2) Inhibitors: A
`Review of Their Basic and Clinical Pharmacology, Diabetes Ther., 2014
`Dec.; 5(2):355-366.
`EX2377 Janssen Pharmaceuticals, Inc., “U.S. FDA Approves INVOKANA™
`(Canagliflozin) for the Treatment of Adults with Type 2 Diabetes,”
`https://www.prnewswire.com/news-releases/us-fda-approves-invokana-
`canagliflozin-for-the-treatment-of-adults-with-type-2-diabetes-
`200638361.html (Mar. 29, 2013)
`EX2378 American Diabetes Association, “Life with Diabetes: Get the Right Care
`for You,” http://www.diabetes.org/living-with-diabetes/treatment-and-care.
`EX2379 Novo Nordisk, “Managing your diabetes,”
`https://www.mynovoinsulin.com/diabetes-education/managing-
`diabetes.html, last updated Dec. 2022.
`EX2380 Mayo Clinic, “A1C test,” https://www.mayoclinic.org/tests-procedures/
`a1c-test/about/pac-20384643, last updated Dec. 1, 2022.
`EX2381 Valentine, V., Goldman, J. and Shubrook, J.H., Rationale for, Initiation
`and Titration of the Basal Insulin/GLP-1RA Fixed-Ratio Combination
`Products, IDegLira and IGlarLixi, for the Management of Type 2 Diabetes,
`Diabetes Ther., 2017 July; 8:739-752.
`EX2382 Boyes, K.S., et al., Physician Perceptions of Dose Escalation for Type 2
`Diabetes Medications in the United States, Diabetes Ther., 2023 Nov.,
`https://doi.org/10.1007/s13300-023-01499-x.
`
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`IPR2023-00724
`U.S. Patent 10,335,462
`
`Exhibit Description
`EX2383 Bishop, S., “Losing Weight Can Have Big Impact on Those With
`Diabetes,” https://newsnetwork.mayoclinic.org/discussion/losing-weight-
`can-have-big-impact-on-those-with-diabetes (Dec. 14, 2012).
`EX2384 Clamp, L.D., et al., Enhanced insulin sensitivity in successful, long-term
`weight loss maintainers compared with matched controls with no weight
`loss history, Nutrition & Diabetes, 2017; 7:e282
`EX2385 Wilding, J.P.H., The importance of weight management in type 2 diabetes
`mellitus, Int. J. Clin. Pract., 2014 Jun; 68(6):682-691
`EX2386 National Institute for Health and Care Research, “Losing weight following
`type 2 diabetes diagnosis boosts chance of remission,”
`https://evidence.nihr.ac.uk/not-articletype/losing-weight-following-type-2-
`diabetes-diagnosis-boosts-chance-of-remission (Nov. 21, 2019)
`EX2387 American Heart Association, “Cardiovascular Disease and Diabetes,”
`https://www.heart.org/en/health-topics/diabetes/diabetes-complications-
`and-risks/cardiovascular-disease--diabetes, last reviewed May 4, 2021.
`EX2388 Cramer, J.A., Medication compliance and persistence: terminology and
`definitions, Value Health 2008 Jan-Feb; 11(1):44-47.
`EX2389 Ho, P.M., Bryson, C.L., and Rumsfeld, J.S., Medication Adherence,
`Circulation, 2009; 119(23):3028-3035.
`EX2390 Usherwood, T., Encouraging adherence to long-term medication, Aust.
`Prescr., 2017 Aug.; 40(4):147-150.
`EX2391 Brown, M.T. and Bussell, J.K., Medication Adherence: WHO Cares?,
`Mayo Clin. Proc., 2011 Apr.; 86(4): 304-314.
`EX2392 Baryakova, T.H., et al., Overcoming barriers to patient adherence: the case
`for developing innovative drug delivery systems, Nature Reviews Drug
`Discovery, 2023; 22:387-409.
`EX2393 DiBonaventura, M.d., et al., Multinational Internet-based survey of patient
`preference for newer oral or injectable Type 2 diabetes medication, Patient
`Prefer. Adherence, 2010; 4:397-406.
`EX2394 Mansfield, C., et al., Patient Preferences for Attributes of Type 2 Diabetes
`Mellitus Medications in Germany and Spain: An Online Discrete-Choice
`Experiment Survey, Diabetes Ther., 2017 Dec.; 8(6):1365-1378.
`EX2395 Byetta® Prescribing Information (rev. Feb. 2015)
`EX2396 U.S. Food & Drug Administration, Drugs@FDA, Byetta®
`EX2397 U.S. Food & Drug Administration, FDA List of Authorized Generics,
`https://www.fda.gov/media/77725/download, last updated Jan. 4, 2024
`EX2398 Januvia® Prescribing Information (rev. Feb. 2018)
`EX2399 U.S. Food & Drug Administration, Drugs@FDA, Januvia®
`
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`IPR2023-00724
`U.S. Patent 10,335,462
`
`Exhibit Description
`EX2400 Janumet® Prescribing Information (rev. Feb. 2018)
`EX2401 U.S. Food & Drug Administration, Drugs@FDA, Janumet®
`EX2402 U.S. Food & Drug Administration, Drugs@FDA, Janumet® XR
`EX2403 Onglyza® Prescribing Information (rev. Feb. 2017)
`EX2404 U.S. Food & Drug Administration, Drugs@FDA, Onglyza®
`EX2405 U.S. Food & Drug Administration, Orange Book: Approved Drug Products
`with Therapeutic Equivalence Evaluations, ANDA 205981
`EX2406 Aurobindo, “Aurobindo Received FDA Approval for Saxagliptin Tablets,
`2.5mg and 5mg,” https://www.aurobindousa.com/news/product-
`news/aurobindo-receives-fda-approval-for-saxagliptin-tablets-2-5mg-and-
`5mg/ (July 31, 2023).
`EX2407 Victoza® Prescribing Information (rev. Nov. 2020)
`EX2408 U.S. Food & Drug Administration, Drugs@FDA, Victoza®
`EX2409 Victoza® Prescribing Information (rev. Aug. 2017)
`EX2410 Novo Nordisk, “Dosing and administering Victoza®,”
`https://www.novomedlink.com/diabetes/products/treatments/victoza/
`dosing-administration.html.
`EX2411 Kombiglyze® XR Prescribing Information (rev. Feb. 2017)
`EX2412 U.S. Food & Drug Administration, Drugs@FDA, Kombiglyze® XR
`EX2413 U.S. Food & Drug Administration, Orange Book: Approved Drug Products
`with Therapeutic Equivalence Evaluations, ANDA 206081
`EX2414 Tradjenta® Prescribing Information (rev. Aug. 2017)
`EX2415 U.S. Food & Drug Administration, Drugs@FDA, Tradjenta®
`EX2416 U.S. Food & Drug Administration, Orange Book: Approved Drug Products
`with Therapeutic Equivalence Evaluations, ANDA 208335
`EX2417 AstraZeneca, “AstraZeneca and Bristol-Myers Squibb complete expansion
`of diabetes alliance through Bristol-Myers Squibb’s acquisition of Amylin
`Pharmaceuticals,” https://www.astrazeneca.com/media-centre/press-
`releases/2012/AstraZeneca-and-Bristol-Myers-Squibb-complete-
`expansion-of-diabetes-alliance-through-Bristol-Myers-Squibbs-
`acquisition-of-Amylin-Pharmaceuticals-09082012.html (Aug. 9, 2012)
`EX2418 U.S. Food & Drug Administration, Drugs@FDA, Bydureon®
`EX2419 --intentionally omitted--
`EX2420 Bydureon® BCISE™ Prescribing Information (rev. Oct. 2017)
`EX2421 U.S. Food & Drug Administration, Drugs@FDA, Bydureon® BCISE™
`EX2422 Jentadueto® Prescribing Information (rev. Aug. 2017)
`EX2423 U.S. Food & Drug Administration, Drugs@FDA, Jentadueto®
`EX2424 U.S. Food & Drug Administration, Drugs@FDA, Jentadueto® XR
`
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`IPR2023-00724
`U.S. Patent 10,335,462
`
`Exhibit Description
`EX2425 Jentadueto® XR Prescribing Information (rev. Dec. 2016)
`EX2426 Nesina® Prescribing Information (rev. Dec. 2016)
`EX2427 U.S. Food & Drug Administration, Drugs@FDA, Nesina®
`EX2428 Kazano® Prescribing Information (rev. Feb. 2017)
`EX2429 U.S. Food & Drug Administration, Drugs@FDA, Kazano®
`EX2430 Oseni® Prescribing Information (rev. Dec. 2017)
`EX2431 U.S. Food & Drug Administration, Drugs@FDA, Oseni®
`EX2432 Invokana® Prescribing Information (rev. July 2017)
`EX2433 U.S. Food & Drug Administration, Drugs@FDA, Invokana®
`EX2434 Farxiga® Prescribing Information (rev. Oct. 2017)
`EX2435 U.S. Food & Drug Administration, Drugs@FDA, Farxiga®
`EX2436 Tanzeum® Prescribing Information (rev. Dec. 2017)
`EX2437 U.S. Food & Drug Administration, Drugs@FDA, Tanzeum®
`EX2438 Hoerman, J., “Tanzeum (albiglutide) Discontinued After FDA Warns of
`Risk of Anaphylaxis Reaction,” https://trulaw.com/fda/tanzeum-
`albiglutide-anaphylaxis-reaction (Nov. 21, 2017).
`EX2439 Jardiance® Prescribing Information (rev. Dec. 2017)
`EX2440 U.S. Food & Drug Administration, Drugs@FDA, Jardiance®
`EX2441 Jardiance® Prescribing Information (rev. Dec. 2016)
`EX2442 Invokamet® Prescribing Information (rev. Aug. 2017)
`EX2443 U.S. Food & Drug Administration, Drugs@FDA, Invokamet®
`EX2444 U.S. Food & Drug Administration, Drugs@FDA, Invokamet®