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 UNOPPOSED MOTION FOR
`PRO HAC VICE ADMISSION OF JENNY C. WU
`
`
`
`
`

`

`LIST OF EXHIBITS
`
`IPR2024-00724
`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, Au-
`thor 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 In-
`validity 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 Kid-
`ney Function in People with Overweight or Obesity With or Without
`Type 2 Diabetes: Exploratory Analysis from the STEP 1, 2 and 3 Tri-
`als,” 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)
`
`i
`
`
`

`

`
`
`IPR2023-00724
`U.S. Patent 10,335,462
`
`Exhibit Description
`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-inflam-
`matory 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, Pharma-
`ceutical Development (produced as NN-OZEM-000158851) [UNDER
`SEAL]
`EX2022 April 22, 2009 NN9535-1821 Key Results Meeting Presentation (pro-
`duced as NN-OZEM-004470861) [UNDER SEAL]
`EX2023 April 22, 2009 email from Lise Brondsted to Christine Jensen et al (pro-
`duced 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 Meet-
`ing 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]
`
`
`
`ii
`
`

`

`
`
`IPR2023-00724
`U.S. Patent 10,335,462
`
`Exhibit Description
`EX2032 April 23, 2012 NN9535-3819 Key Result Meeting presentation (pro-
`duced 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 (pro-
`duced 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]
`EX2037 --intentionally omitted--
`EX2038 March 11, 2010 email from Anne Flint to Nilas Ohrner, copying Chris-
`tine Jensen (produced as NN-OZEM-004442969) [UNDER SEAL]
`EX2039 March 11, 2010 draft Semaglutide Dose selection for phase 3 presenta-
`tion (produced as NN-OZEM-004442970) [UNDER SEAL]
`EX2040 November 26, 2010 draft Clinical Trial Protocol for NN9535-3819 (pro-
`duced as NN-OZEM-004434630) [UNDER SEAL]
`EX2041 November 26, 2010 email from Anne Flint to Christine Jensen et al (pro-
`duced 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 RE-
`DACTED COPIES]
`EX2051 Declaration of Anne Flint [UNDER SEAL AND REDACTED COP-
`IES]
`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.
`
`
`
`iii
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`

`

`
`
`IPR2023-00724
`U.S. Patent 10,335,462
`
`Exhibit Description
`EX2056 Declaration of Patrick J. Sinko, Ph.D. [UNDER SEAL AND RE-
`DACTED COPIES]
`EX2057 Declaration of Jenna DiCicco
`EX2058 Declaration of Sayem Osman
`EX2059 Declaration of Vanessa Costain
`EX2060 Rosenstock, J., et al., “The Fate of Taspoglutide, a Weekly GLP-1 Re-
`ceptor 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/ar-
`ticles/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,” availa-
`ble at https://professionals.optumrx.com/content/dam/optum3/profes-
`sional-optumrx/news/rxnews/drug-recalls-shortages/drugwith-
`drawal_tanzeum_2017-0801.pdf (2017)
`EX2064 Synapse, “Pegylated GLP-1 analogue (LY2428757) – (Eli Lilly &
`Co.),”
`available
`at
`https://syn-
`apse.patsnap.com/drug/482a547adeba4170ab23efa225fb966d (last up-
`dated 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 Delib-
`eration
`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://clin-
`icaltrials.gov/study/NCT03144271 (last visited December 28, 2023)
`EX2071 Claim Construction Order, In re: Ozempic (Semaglutide) Patent Litiga-
`tion, MDL No. 22-MD-3038, Dkt. No. 148 (D. Del. July 25, 2023)
`
`
`
`iv
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`

`
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`IPR2023-00724
`U.S. Patent 10,335,462
`
`Exhibit Description
`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/prod-
`uct/9750/smpc#gref (last visited January 12, 2024)
`EX2074 Ozempic® Prescribing Information (Australian Product Information)
`(December 2020) available at https://www.novonordisk.com.au/con-
`tent/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 In-
`crease 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.li-
`bretexts.org/Courses/University_of_South_Carolina__Upstate/
`USC_Upstate%3A_CHEM_U109_-_Chemistry_of_Liv-
`ing_Things_(Mueller)/09%3A_Solutions/9.1%3A_Solutions (last vis-
`ited January 16, 2024)
`EX2078 Blüher, M. et al., “Dose-response effects on HbA1c and bodyweight re-
`duction of survodutide, a dual glucagon/GLP-1 receptor agonist, com-
`pared 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-re-
`view/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 & Me-
`tabolism 46 100-109 (2020)
`
`
`
`v
`
`

`

`
`
`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 sul-
`fonylureas) 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 pa-
`tients 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 Cardi-
`ometabolic Disease,” https://www.acc.org/Clinical-Topics/Diabetes-
`and-Cardiometabolic-Disease (last visited Jan. 16, 2024).
`EX2089 American Society for Preventive Cardiology, “Cardiometabolic Fellow-
`ship,”
`https://www.aspconline.org/professional-development/cardi-
`ometabolic-fellowship/ (last visited Jan. 16, 2024).
`EX2090 Cosentino, F. et al., ESC Guidelines on diabetes, pre-diabetes, and car-
`diovascular 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. Car-
`diol., 72: 3200-3223 (2018)
`EX2092 Das, S.R., et al., Expert Consensus Decision Pathway on Novel Thera-
`pies for Cardiovascular Risk Reduction in Patients with Type 2 Diabe-
`tes, 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 cardi-
`ovascular benefits of once-weekly subcutaneous semaglutide and dulag-
`lutide 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 neuro-
`logical 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 Diabe-
`tes, Curr. Atheroscler. Rep., 24:925-937 (2022)
`EX2099 Kleindorfer, D.O., et al., Guideline for the Prevention of Stroke in Pa-
`tients 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 gen-
`der, age, and baseline CV risk profile in the SUSTAIN 6 trial, Cardio-
`vasc. Diabetol., 18:73 (2019)
`EX2101 Marso, S.P., et al., Semaglutide and Cardiovascular Outcomes in Pa-
`tients with Type 2 Diabetes, N. Engl. J. Med., 375:1834-1844 (2016)
`EX2102 Marso, S.P., et al., Supplementary Appendix to Semaglutide and Cardi-
`ovascular 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 Ather-
`osclerotic Cardiovascular Risk in Patients with Type 2 Diabetes, Circu-
`lation, 146:1882-1894 (2022)
`EX2104 Maskery, M.P., et al., Glucagon-like peptide-1 receptor agonists as neu-
`roprotective 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 Pep-
`tidase-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)
`
`
`
`vii
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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 Special-
`ist, 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 recep-
`tor 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 macrovascu-
`lar and microvascular disease in type 2 diabetes? Insights from AC-
`CORD, 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) [UN-
`DER 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]
`
`
`
`viii
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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) [UN-
`DER 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 Perfor-
`mance Report spreadsheet (produced as NN-OZEM-004063922) [UN-
`DER SEAL]
`EX2313 November 5, 2019 Market Overview/GLP-1 Strategy presentation (pro-
`duced 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 (pro-
`duced 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 presenta-
`tion (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 In-
`sights Report presentation (produced as NN-OZEM-004687270) [UN-
`DER SEAL]
`EX2323 February 26, 2019 Ozempic® US Launch Tracker presentation (pro-
`duced as NN-OZEM-004688496) [UNDER SEAL]
`EX2324 May 2017 Brand Strategy 2018 GLP-1 Franchise presentation (pro-
`duced as NN-OZEM-004690786) [UNDER SEAL]
`
`
`
`ix
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`

`
`
`IPR2023-00724
`U.S. Patent 10,335,462
`
`Exhibit Description
`EX2325 February 23, 2022 Quarterly Insights Report – Q4’ 2021, Diabetes Inte-
`grated Insights Ecosystem presentation (produced as NN-OZEM-
`004691302) [UNDER SEAL]
`EX2326 November 16, 2021 Quarterly Insights Report – Q3’ 2021, Diabetes In-
`tegrated Insights Ecosystem presentation (produced as NN-OZEM-
`004691816) [UNDER SEAL]
`EX2327 February 17, 2021 Integrated Insights Ecosystem, Wave 4 Quarterly In-
`sights Report presentation (produced as NN-OZEM-004701779) [UN-
`DER 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 & Recom-
`mendations presentation (produced as NN-OZEM-004731509) [UN-
`DER SEAL]
`EX2333 August 11, 2020 Integrated Insights Ecosystem, Wave 2 Quarterly Re-
`port 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/diabe-
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`EX2352 Mayo Clinic, “Diabetes – Symptoms & causes,” https://www.mayo-
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`toms-causes/syc-20373631, last updated Aug. 20, 2022.
`
`
`
`x
`
`

`

`
`
`IPR2023-00724
`U.S. Patent 10,335,462
`
`Exhibit Description
`EX2354 Centers for Disease Control and Prevention, “Gestational Diabetes,”
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`last
`reviewed
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`EX2356 Centers for Disease Control and Prevention, National Diabetes Statistics
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`EX2357 National Institute of Diabetes and Digestive Kidney Diseases, “Type 2
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`abetic Medications, https://www.medscape.com/viewarticle/722513_3
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`formation/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
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`“Biguanides,”
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`
`
`xi
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`

`
`
`IPR2023-00724
`U.S. Patent 10,335,462
`
`Exhibit Description
`EX2370 White, Jr., J.R., A Brief History of the Development of Diabetes Medi-
`cations, Diabetes Spectr. 2014;27(2):82-86.
`EX2371 U.S. Food & Drug Administration, Drugs@FDA, Prandin®
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`EX2379 Novo Nordisk, “Managing your diabetes,” https://www.mynovoin-
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`
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`xii
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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 Dia-
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`EX2396 U.S. Food & Drug Administration, Drugs@FDA, Byetta®
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`
`
`
`xiii
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`IPR2023-00724
`U.S. Patent 10,335,462
`
`Exhibit Description
`EX2399 U.S. Food & Drug Administration, Drugs@FDA, Januvia®
`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 Prod-
`ucts with Therapeutic Equivalence Evaluations, ANDA 205981
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`EX2407 Victoza® Prescribing Information (rev. Nov. 2020)
`EX2408 U.S. Food & Drug Administration, Drugs@FDA, Victoza®
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`EX2410 Novo Nordisk, “Dosing and administering Victoza®,” https://www.no-
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`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 Prod-
`ucts with Therapeutic Equivalence Evaluations, ANDA 206081
`EX2414 Tradjenta® Prescribing Information (rev. Aug. 2017)
`EX2415 U.S. Food & Drug Administration, Drugs@FDA, Tradjenta®
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`ucts with Therapeutic Equivalence Evaluations, ANDA 208335
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`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®
`
`
`
`xiv
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`

`
`
`IPR2023-00724
`U.S. Patent 10,335,462
`
`Exhibit Description
`EX2424 U.S. Food & Drug Administration, Drugs@FDA, Jentadueto® XR
`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)
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`EX2439 Jardiance® Prescribing Information (rev. Dec. 2017)
`EX2440 U.S. Food & Drug Administration, Drugs@FDA, Jardiance®
`EX2441 Jardiance® Prescribing Information (rev. Dec. 2016)