Case 1:18-cv-01363-CFC Document 82 Filed 03/22/19 Page 1 of 5 PageID #: 9727
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
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`C.A. No. 18-924-CFC
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`C.A. No. 18-1363-CFC
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`GENENTECH, INC. and CITY OF HOPE, )
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`Plaintiffs and Counterclaim Defendants,
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`AMGEN INC.,
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`Defendant and Counterclaim Plaintiff.
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`GENENTECH, INC. and CITY OF HOPE, )
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`Plaintiffs and Counterclaim Defendants,
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`SAMSUNG BIOEPIS CO., LTD,
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`Defendant and Counterclaim Plaintiff.
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`DECLARATION OF MICHELLE S. RHYU
`IN SUPPORT OF DEFENDANTS’
`CLAIM CONSTRUCTION BRIEF
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`
`C.A. No. 18-924-CFC
`
`C.A. No. 18-1363-CFC
`
`
`GENENTECH, INC. and CITY OF HOPE, )
`
`
`
`
`
`
`
`)
`Plaintiffs and Counterclaim Defendants,
`)
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`)
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`
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`v.
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`)
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`)
`AMGEN INC.,
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`)
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`Defendant and Counterclaim Plaintiff.
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`GENENTECH, INC. and CITY OF HOPE, )
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`)
`Plaintiffs and Counterclaim Defendants,
`)
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`)
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`v.
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`SAMSUNG BIOEPIS CO., LTD,
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`
`)
`Defendant and Counterclaim Plaintiff.
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`DECLARATION OF MICHELLE S. RHYU
`IN SUPPORT OF DEFENDANTS’
`CLAIM CONSTRUCTION BRIEF
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`Case 1:18-cv-01363-CFC Document 82 Filed 03/22/19 Page 2 of 5 PageID #: 9728
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`I, Michelle Rhyu, declare as follows:
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`1.
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`I am a partner at the law firm of Cooley LLP, counsel for Amgen, Inc.
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`(“Amgen”) in Case No. 18-cv-00924-CFC (D. Del.). I am familiar with the facts set
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`forth herein, and if called as a witness, I could and would testify competently to those
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`facts under oath.
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`2.
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`I submit this declaration in support of Defendant’s Claim Construction
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`Brief.
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`3.
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`Attached hereto as Exhibit 1 is a true and correct copy of the
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`Herceptin® (Trastuzumab) label (September 1998) (“Herceptin 1998 Label”). A
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`copy of this label was also submitted on November 6, 2013 in the U.S. Patent No.
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`10,160,811 File History.
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`4.
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`Attached hereto as Exhibit 2 is a true and correct copy of an
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`Information Disclosure Statement from the U.S. Patent No. 10,160,811 File History,
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`as submitted on November 6, 2013 (“Nov. 6, 2013 IDS”).
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`5.
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`Attached hereto as Exhibit 3 is a true and correct copy of the
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`Herceptin® (Trastuzumab) label (November 2018) (“Herceptin 2018 Label”).
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`6.
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`Attached hereto as Exhibit 4 is a true and correct copy of excerpts from
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`Rowland, et al., Clinical Pharmacokinetics: Concepts and Applications,
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`LIPPINCOTT WILLIAMS & WILKINS (3rd ed. 1995) (“Rowland & Tozer 1995”).
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`2
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`Case 1:18-cv-01363-CFC Document 82 Filed 03/22/19 Page 3 of 5 PageID #: 9729
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`7.
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`Attached hereto as Exhibit 5 is a true and correct copy of an excerpt
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`from Webster's New College Dictionary (1999) (“Webster's New College
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`Dictionary”).
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`8.
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`Attached hereto as Exhibit 6 is a true and correct copy of Pauletti, et
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`al., Detection and quantitation of HER-2/neu gene amplification in human breast
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`cancer archival material using fluorescence in situ hybridization, ONCOGENE,
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`13:63-72 (1996) (“Pauletti 1996”).
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`9.
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`Attached hererto as Exhibit 7 is a true and correct copy of Pegram, et
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`al., HER-2/neu as a predictive marker of response to breast cancer therapy,
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`BREAST CANCER RESEARCH AND TREATMENT, 52:65-77 (1998) (“Pegram
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`1998”).
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`10. Attached hereto as Exhibit 8 is a true and correct copy of Jacobs, et al.,
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`Comparison of Fluorescence In Situ Hybridization and Immunohistochemistry for
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`the Evaluation of HER-2/neu in Breast Cancer, JOURNAL OF CLINICAL
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`ONCOLOGY, 17(7):1974-82 (1999) (“Jacobs 1999”).
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`11. Attached hereto as Exhibit 9 is a true and correct copy of Baselga, et
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`al., Phase II Study of Weekly Intravenous Trastuzumab (Herceptin) in Patients With
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`HER2/neu-Overexpressing Metastatic Breast Cancer, SEMIN ONCOL., 26(4 Suppl
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`12):78-83 (1999) (“Baselga 1999”).
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`3
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`Case 1:18-cv-01363-CFC Document 82 Filed 03/22/19 Page 4 of 5 PageID #: 9730
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`12. Attached hereto as Exhibit 10 is a true and correct copy of Check, More
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`than one way to look for HER2, CAP TODAY, 13(3) (1999) (“Check 1999”).
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`13. Attached hereto as Exhibit 11 is a true and correct copy of Slamon, et
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`al., Studies of the HER-2/neu Proto-oncogene in Human Breast and Ovarian Cancer,
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`SCIENCE, 244(4905):707-12 (1989) (“Slamon 1989”).
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`14. Attached hereto as Exhibit 12 is a true and correct copy of Press, et al.,
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`Sensitivity of HER-2/neu Antibodies in Archival Tissue Samples: Potential Source of
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`Error in Immunohistochemical Studies of Oncogene Expression, CANCER RES.,
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`54(10):2771-77 (1994) (“Press 1994”).
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`15. Attached hereto as Exhibit 13 is a true and correct copy of Press, et al.,
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`HER-2/neu Gene Amplification Characterized by Fluorescence
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`In Situ
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`Hybridization: Poor Prognosis in Node-Negative Breast Carcinomas, JOURNAL
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`OF CLINICAL ONCOLOGY, 15(8):2894-904 (1997) (“Press 1997”).
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`16. Attached hereto as Exhibit 14 is a true and correct copy of Nelson,
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`Nancy J., Experts Debate Value Of HER2 Testing Methods, JOURNAL OF NAT.
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`CANCER INSTITUTE, 92(4):292-94 (2000) (“Nelson 2000”).
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`17. Attached hereto as Exhibit 15 is a true and correct copy of deposition
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`transcript of Holly Prentice, Ph.D., dated February 1, 2019 (“Prentice Tr.”).
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`Case 1:18-cv-01363-CFC Document 82 Filed 03/22/19 Page 5 of 5 PageID #: 9731
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`I declare under penalty of perjury that the foregoing is true and correct to the
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`best of my knowledge.
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`EXECUTED this 15th day of February, 2019.
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`By: /s/ Michelle S. Rhyu
` Michelle S. Rhyu
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