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`UNITED STATES PATENT AND TRADEMARK OFFICE
`______________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`______________
`
`PFIZER INC.,1
`Petitioner,
`
`v.
`
`NOVO NORDISK A/S,
`Patent Owner.
`______________
`
`Case IPR2020-003242
`Patent 8,114,833
`______________
`
`
`PATENT OWNER’S UPDATED LIST OF EXHIBITS
`
`
`
`
`
`
`1 The proceeding has been terminated as to the original petitioner, Mylan
`Institutional LLC. Paper 67.
`2 IPR2020-01252 has been joined with this proceeding. Paper 33.
`
`

`

`IPR2020-00324
`Patent 8,114,833
`
`DESCRIPTION
`Declaration of Ryan P. Johnson in Support of Patent Owner’s
`Motion for Admission Pro Hac Vice of Ryan P. Johnson Under 37
`C.F.R. § 42.10(c)
`Declaration of Laura T. Moran in Support of Patent Owner’s Motion for
`Admission Pro Hac Vice of Laura T. Moran Under 37 C.F.R. § 42.10(c)
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`Mark C. Manning et al., Stability of Protein Pharmaceuticals, 6
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`R.W. Payne, et al., Peptide Formulation: Challenges and Strategies,
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`Dean K. Clodfelter et al., Effects of Non-Covalent Self-Association
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`Eva Y. Chi et al., Physical Stability of Proteins in Aqueous Solution:
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`U.S. Patent No. 5,932,547
`Lotte Knudsen, et al., Potent Derivatives of Glucagon-like Peptide-1
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`U.S. Patent Application Publication No. 2002/0061838
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`Alfred Doenicke, et al., Osmolalities of Propylene Glycol-
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`IPR2020-00324
`Patent 8,114,833
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`(Confidential – Protective Order Material)
`Declaration of Dorthe Kot Engelund dated September 16, 2020
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`Declaration of Tina Bjeldskov Pedersen, Ph.D. dated September 17, 2020
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`Patent 8,114,833
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`Wolffenbuttel, B. H., & Graal, M. B. New treatments for patients with
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`(1996)
`Highlights of Prescribing Information, Revised 08/2020 (“Victoza®
`Prescribing Information”)
`Internal Novo Nordisk Report, dated December 3, 2001 (Confidential –
`Protective Order Material)
`Internal Novo Nordisk Email Chain, beginning December 19, 2001 and
`certified translation thereof (Confidential – Protective Order Material)
`Internal Novo Nordisk Report, dated December 19, 2001 and certified
`translation thereof (Confidential – Protective Order Material)
`Internal Novo Nordisk Protocol, dated January 22, 2002 and certified
`translation thereof (Confidential – Protective Order Material)
`De Vos, A. M., et al. Human growth hormone and extracellular domain
`of its receptor: crystal structure of the complex. 255 SCIENCE, 306-312
`(1992)
`Internal Novo Nordisk Meeting Minutes, dated April 12, 2002 and
`certified translation thereof (Confidential – Protective Order Material)
`Internal Novo Nordisk Protocol, dated April 29, 2002 (Confidential –
`Protective Order Material)
`Internal Novo Nordisk Protocol, dated June 3, 2002 and certified
`translation thereof (Confidential – Protective Order Material)
`Internal Novo Nordisk Study Plan, dated June 5, 2002 and certified
`translation thereof (Confidential – Protective Order Material)
`Internal Novo Nordisk Memo, dated June 27, 2002 and certified
`translation thereof (Confidential – Protective Order Material)
`
`4
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`2044
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`2045
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`2046
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`2048
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`2049
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`2050
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`2051
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`2052
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`2053
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`2054
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`2055
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`2056
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`2057
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`2058
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`2059
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`IPR2020-00324
`Patent 8,114,833
`
`Internal Novo Nordisk Study Plan, dated July 23, 2002 and certified
`translation thereof (Confidential – Protective Order Material)
`Center for Drug Evaluation and Research “Final Printed Labeling –
`Application Number 21-319: FORTEO” (2002)
`Internal Novo Nordisk Lab Notebook (excerpt), dated July 24, 2002 and
`certified translation thereof (Confidential – Protective Order Material)
`Internal Novo Nordisk Meeting Minutes, dated November 14, 2002 and
`certified translation thereof (Confidential – Protective Order Material)
`Internal Novo Nordisk Design Review Presentation, dated November 29,
`2002 (Confidential – Protective Order Material)
`Internal Novo Nordisk Meeting Minutes, dated February 3, 2003 and
`certified translation thereof (Confidential – Protective Order Material)
`Internal Novo Nordisk Statement, dated April 9, 2003 (Confidential –
`Protective Order Material)
`Internal Novo Nordisk Report, dated April 10, 2003 (Confidential –
`Protective Order Material)
`Internal Novo Nordisk Report, dated April 22, 2003 (Confidential –
`Protective Order Material) (“April 22, 2003 Report”)
`Internal Novo Nordisk Report, dated June 10, 2003 and certified
`translation thereof (Confidential – Protective Order Material)
`Internal Novo Nordisk Trial Protocol, dated June 11, 2003 (Confidential
`– Protective Order Material)
`Internal Novo Nordisk Report, dated June 18, 2003 (Confidential –
`Protective Order Material)
`Internal Novo Nordisk Report, dated June 27, 2003 (Confidential –
`Protective Order Material)
`Internal Novo Nordisk Protocol, dated January 30, 2018 (Confidential –
`Protective Order Material)
`Internal Novo Nordisk Report, dated May 17, 2018 (Confidential –
`Protective Order Material)
`Internal Novo Nordisk Report, dated May 17, 2018 (Confidential –
`Protective Order Material)
`Berg, J. M. et al. Biochemistry: Chapter 3: Protein Structure and
`Function, 5 W.H. FREEMAN AND COMPANY, 41-76 (2002) (“Berg”)
`Physician’s Desk Reference, 54th ed., “Norditropin” pp. 2061-2062
`(2000)
`Physician’s Desk Reference, Supplement A, “Humira” pp. A5-A6 (2003)
`Deposition Transcript of Laird Forrest, Ph.D., dated September 3, 2020
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`5
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`2060
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`2061
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`2062
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`2063
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`2064
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`2065
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`2066
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`2068
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`2069
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`IPR2020-00324
`Patent 8,114,833
`
`Redacted Version of Declaration of Peter Tessier, Ph.D. dated September
`18, 2020
`Remington’s Pharmaceutical Science, Vol. I, 19th ed., Chapter 36 (1995)
`(“Remington 1995”)
`Claim Construction Order in Novo Nordisk Inc. et al. v. Mylan
`Institutional LLC, C.A. No. 19-1551 (CFC) (SRF), D.I. 106 (D. Del.
`Sept. 17, 2020)
`Supplemental Evidence to Resolve Objection to Exhibit 2051: Internal
`Novo Nordisk Email Chain, beginning December 19, 2001 and certified
`translation thereof (Confidential – Protective Order Material)
`Supplemental Evidence to Resolve Objection to Exhibit 2052: Internal
`Internal Novo Nordisk Report, dated December 19, 2001 and certified
`translation thereof (Confidential – Protective Order Material)
`Supplemental Evidence to Resolve Objection to Exhibit 2053: Internal
`Internal Novo Nordisk Protocol, dated January 22, 2002 and certified
`translation thereof (Confidential – Protective Order Material)
`Supplemental Evidence to Resolve Objection to Exhibit 2055: Internal
`Novo Nordisk Meeting Minutes, dated April 12, 2002 and certified
`translation thereof (Confidential – Protective Order Material)
`Supplemental Evidence to Resolve Objection to Exhibit 2057: Internal
`Novo Nordisk Protocol, dated June 3, 2002 and certified translation
`thereof (Confidential – Protective Order Material)
`Supplemental Evidence to Resolve Objection to Exhibit 2058: Internal
`Novo Nordisk Study Plan, dated June 5, 2002 and certified translation
`thereof (Confidential – Protective Order Material)
`Supplemental Evidence to Resolve Objection to Exhibit 2059: Internal
`Novo Nordisk Memo, dated June 27, 2002 and certified translation
`thereof (Confidential – Protective Order Material)
`Supplemental Evidence to Resolve Objection to Exhibit 2060: Internal
`Novo Nordisk Study Plan, dated July 23, 2002 and certified translation
`thereof (Confidential – Protective Order Material)
`Supplemental Evidence to Resolve Objection to Exhibit 2062: Internal
`Novo Nordisk Lab Notebook (excerpt), dated July 24, 2002 and certified
`translation thereof (Confidential – Protective Order Material)
`Supplemental Evidence to Resolve Objection to Exhibit 2063: Internal
`Novo Nordisk Meeting Minutes, dated November 14, 2002 and certified
`translation thereof (Confidential – Protective Order Material)
`
`6
`
`
`2080
`
`2081
`
`2082
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`2083*
`
`2084*
`
`2085*
`
`2086*
`
`2087*
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`2088*
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`2089*
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`2090*
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`2091*
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`2092*
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`

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`IPR2020-00324
`Patent 8,114,833
`
`Supplemental Evidence to Resolve Objection to Exhibit 2065: Internal
`Novo Nordisk Meeting Minutes, dated February 3, 2003 and certified
`translation thereof (Confidential – Protective Order Material)
`Supplemental Evidence to Resolve Objection to Exhibit 2069: Internal
`Novo Nordisk Report, dated June 10, 2003 and certified translation
`thereof (Confidential – Protective Order Material)
`Witte, R., & Witte, J. Chapter 11: More about Hypothesis Testing. 11
`STATISTICS, 195-220 (2017)
`Deposition Transcript of Laird Forrest, Ph.D., dated January 21, 2021
`(Confidential – Protective Order Material)
`Redacted Version of Deposition Transcript of Laird Forrest, Ph.D., dated
`January 21, 2021
`Confidential Settlement Agreement (Business Confidential Information)
`
`Redacted Version of Declaration of Dorthe Kot Engelund, dated
`September 16, 2020
`Redacted Version of Deposition Transcript of Dorthe Kot Engelund,
`dated November 20, 2020
`Redacted Version of Deposition Transcript of Tina B. Pedersen, Ph.D.,
`dated November 24, 2020
`Confidential Settlement Agreement (Business Confidential Information)
`
`
`
`2093*
`
`2094*
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`2095
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`2096
`
`2097
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`2098
`
`2099
`
`2100
`
`2101
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`2102
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` *
`
` Indicates that the Exhibit was served on Petitioner Mylan Institutional LLC, but
`was not filed.
`
`
`
`
`7
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`
`
`CERTIFICATE OF SERVICE
`
`IPR2020-00324
`Patent 8,114,833
`
`Pursuant to 37 C.F.R. §§ 42.6(e), I hereby certify that on June 18, 2021, the
`
`foregoing document is being served by filing this document through the Patent Trial
`
`and Appeal Board End to End System, as well as delivering a copy via electronic
`
`mail upon the following attorneys of record for the Petitioners:
`
`Thomas J. Meloro (Reg. No. 33,538)
`Michael W. Johnson (Reg. No. 63,731)
`Willkie Farr & Gallagher LLP
`787 Seventh Avenue
`New York, NY 10019
`Telephone: (212) 728-8428
`Fax: (212) 728-8111
`tmeloro@willkie.com
`mjohnson1@willkie.com
`amoore@willkie.com
`mao-ny@willkie.com
`
`
`
`Date: June 18, 2021
`
`
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`
`Respectfully submitted,
`
`
`
`
`
`
`
`
`
`
`
`
`
`/ Jeffrey J. Oelke/
`Jeffrey J. Oelke (Reg. No. 37,409)
`
`Counsel for Novo Nordisk A/S
`
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`
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`
`8
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