`FOR THE DISTRICT OF DELAWARE
`
`v.
`
`
`AMGEN INC.,
`
`Defendant and Counterclaim Plaintiff.
`
`
`GENENTECH, INC. and CITY OF HOPE, )
`)
`Plaintiffs and Counterclaim Defendants, )
`)
`)
`)
`)
`)
`)
`)
`
`GENENTECH, INC. and CITY OF HOPE, )
`)
`Plaintiffs and Counterclaim Defendants, )
`)
`)
`)
`)
`)
`)
`)
`
`v.
`
`SAMSUNG BIOEPIS CO., LTD,
`
`Defendant and Counterclaim Plaintiff.
`
`
`
`C.A. No. 18-924-CFC
`
`C.A. No. 18-1363-CFC
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`
`
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`DECLARATION OF NANCY LYNN SCHROEDER IN SUPPORT OF
`
`PLAINTIFFS’ OPENING CLAIM CONSTRUCTION BRIEF
`
`Case 1:18-cv-01363-CFC Document 79 Filed 03/22/19 Page 1 of 3 PageID #: 9409
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`
`
`I, Nancy Lynn Schroeder, declare:
`
`1.
`
`I am an attorney at the law firm of Wilmer Cutler Pickering Hale and
`
`Dorr LLP, counsel for Genentech, Inc. (“Genentech”) in Case Nos. 18-cv-00924-
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`GMS (D. Del.) and 18-cv-01363-GMS (D. Del.). I am familiar with the facts set
`
`forth herein, and if called as witness, I could and would testify competently to
`
`those facts under oath.
`
`2.
`
`I submit this declaration in support of Plaintiffs’ Opening Claim
`
`Construction Brief.
`
`3.
`
`Attached as Exhibit 1 is a true and correct copy of the Curriculum
`
`Vitae of Dr. Hansjörg Hauser.
`
`4.
`Attached as Exhibit 2 is a true and correct copy of Bruce Alberts et
`al., MOLECULAR BIOLOGY OF THE CELL, Chapter 3 (4th Ed. 2002).
`
`5.
`
`Attached as Exhibit 3 is a true and correct copy of Mullan et al.,
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`Disulphide bond reduction of a therapeutic monoclonal antibody during cell
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`culture manufacturing operations, BMC Proc., 22(5) Suppl 8:P110 (2011).
`
`6.
`
`Attached as Exhibit 4 is a true and correct copy of Kao et al.,
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`Mechanism of Antibody Reduction in Cell Culture Production Processes,
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`Biotechnol Bioeng., 107(4):622-32 (2010).
`
`7.
`
`Attached as Exhibit 5 is a true and correct copy of Trexler-Schmidt et
`
`al., Identification and Prevention of Antibody Disulfide Bond Reduction During
`
`Cell Culture Manufacturing, Biotechnol Bioeng., 106(3):452-61 (2010).
`Case 1:18-cv-01363-CFC Document 79 Filed 03/22/19 Page 2 of 3 PageID #: 9410
`8.
`Attached as Exhibit 6 is a true and correct copy of Fahrner et al.,
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`Industrial Purification of Pharmaceutical Antibodies: Development, Operation,
`
`and Validation of Chromatography Processes, Biotechnol Genet Eng Rev.,
`
`18:301-27 (2001).
`
`9.
`
`Attached as Exhibit 7 is a true and correct copy of Birch et al.,
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`Antibody Production, Adv Drug Deliv Rev., 58(5-6):671-85 (2006).
`
`
`
`
`
`
`
`10. Attached as Exhibit 8 is a true and correct copy of Mun et al., Air
`
`Sparging for Prevention of Antibody Disulfide Bond Reduction in Harvested CHO
`
`Cell Culture Fluid, Biotechnol Bioeng., 112(4):734-42 (2015).
`
`11. Attached as Exhibit 9 is a true and correct copy of Hutterer et al.,
`
`Monoclonal Antibody Disulfide Reduction During Manufacturing, MAbs.,
`
`5(4):608-13 (2013).
`
`12. Attached as Exhibit 10 is a true and correct copy of Chung et al.,
`
`Effects of Antibody Disulfide Bond Reduction on Purification Process Performance
`
`and Final Drug Substance Stability, Biotechnol Bioeng., 114(6):1264-1274 (2017).
`
`13. Attached as Exhibit 11 is a true and correct copy of the Curriculum
`
`Vitae of Dr. Holly Prentice.
`
`14. Attached as Exhibit 12 is a true and correct copy of Gibco™ Cell
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`Culture Basics Handbook.
`
`15. Attached as Exhibit 13 is a true and correct copy of Fan et al., Amino
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`Acid and Glucose Metabolism in Fed-Batch CHO Cell Culture Affects Antibody
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`Production and Glycosylation (2014).
`
`16. Attached as Exhibit 14 is a true and correct copy of Wahrheit et al.,
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`Dynamics of Growth and Metabolism Controlled by Glutamine Availability in
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`Chinese Hamster Ovary Cells (2014).
`
` I
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` declare under penalty of perjury that the foregoing is true and correct to the
`Case 1:18-cv-01363-CFC Document 79 Filed 03/22/19 Page 3 of 3 PageID #: 9411
`best of my knowledge.
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`EXECUTED this 11th day of January, 2019.
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`
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`By: /s/ Nancy Lynn Schroeder
`
`Nancy Lynn Schroeder
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