IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`
`GENENTECH, INC. and CITY OF HOPE,
`
`Plaintiffs,
`
`v.
`
`AMGEN INC.,
`
`Defendant and Counterclaim
`Plaintiff.
`
`Case No. 1:18-cv-00924-CFC
`
`PUBLIC VERSION
`
`DECLARATION OF ALISSA M. WOOD IN SUPPORT OF AMGEN’S COMBINED
`OPPOSITION TO GENENTECH’S EMERGENCY MOTIONS FOR A TEMPORARY
`RESTRAINING ORDER AND A PRELIMINARY INJUNCTION
`
`
`FOR THE DISTRICT OF DELAWARE
`
`GENENTECH, INC. and CITY OF HOPE,
`
`Plaintiffs,
`
`v.
`
`AMGEN INC.,
`
`Defendant and Counterclaim
`Plaintiff.
`
`Case No. 1:18-cv-00924-CFC
`
`PUBLIC VERSION
`
`DECLARATION OF ALISSA M. WOOD IN SUPPORT OF AMGEN’S COMBINED
`OPPOSITION TO GENENTECH’S EMERGENCY MOTIONS FOR A TEMPORARY
`RESTRAINING ORDER AND A PRELIMINARY INJUNCTION
`
`
`
`
`
`I, Alissa M. Wood, declare as follows:
`
`1.
`
`I am an associate at the law firm of Cooley LLP, counsel for Amgen, Inc.
`
`(“Amgen”) in Case No. 18-cv-00924-CFC (D. Del.). I am familiar with the facts set forth herein,
`
`and if called as a witness, I could and would testify competently to those facts under oath.
`
`2.
`
`I submit this declaration in support of Amgen’s Combined Opposition to
`
`Genentech’s Emergency Motions for a Temporary Restraining Order and a Preliminary Injunction.
`
`3.
`
`Attached hereto as Exhibit 1 is a true and correct copy of an excerpted version of
`
`the Melissa Abreu Deposition Transcript, dated July 2, 2019. This exhibit is marked Confidential.
`
`4.
`
`Attached hereto as Exhibit 2 is a true and correct copy of Slamon, et al., Addition
`
`of Herceptin (Humanized Anti-Her2 Antibody) to First Line Chemotherapy for Her2
`
`Overexpressing Metastatic Breast Cancer (Her2+/MBC) Markedly Increases Anticancer Activity:
`
`A Randomized, Multinational Controlled Phase III Trial, PROC. AM. SOC. CLIN. ONCOL., 17:98a
`
`(Abstract 377)
`
`(1998)
`
`(“Slamon 1998”), Bates numbered AMGKAN02733994 –
`
`AMGKAN02734003.
`
`5.
`
`Attached hereto as Exhibit 3 is a true and correct copy of Watanabe, et al.,
`
`Pharmacokinetically Guided Dose Escalation Study of Anti-Her2 Monoclonal Antibody in
`
`Patients with Her2/Neu-Overexpressing Metastatic Breast Cancer, PROC. AM. SOC. CLIN. ONCOL.
`
`17:182a (Abstract 702) (1998) (“Watanabe 1998”), Bates numbered AMGKAN002733142 –
`
`AMGKAN02733144.
`
`6.
`
`Attached hereto as Exhibit 4 is a true and correct copy of Baselga, et al., Phase II
`
`Study of Weekly Intravenous Recombinant Humanized Anti-p185HER2 Monoclonal Antibody in
`
`Patients with HER2/neu-Overexpressing Metastatic Breast Cancer, J. CLIN. ONCOL., 14(3):737–
`
`44 (1996) (“Baselga 1996”), Bates numbered AMGKAN01191049 – AMGKAN01191056.
`
`2
`
`
`
`
`
`7.
`
`Attached hereto as Exhibit 5 is a true and correct copy of Pegram, et al., Phase II
`
`Study of Receptor-Enhanced Chemosensitivity Using Recombinant Humanized Anti-p185HER2/neu
`
`Monoclonal Antibody Plus Cisplatin in Patients With HER2/neu-Overexpressing Metastatic Breast
`
`Cancer Refractory to Chemotherapy Treatment, J. CLIN. ONCOL., 16(8):2659-71 (1998) (“Pegram
`
`1998”), Bates numbered AMGKAN01193130 – AMGKAN01193142.
`
`8.
`
`Attached hereto as Exhibit 6 is a true and correct copy of an excerpted version of
`
`the Larry Norton, M.D. Deposition Transcript, dated June 17, 2019.
`
`9.
`
`Attached hereto as Exhibit 7 is a true and correct copy of Marty, et al., Optimizing
`
`Chemotherapy for Patients with Advanced Breast Cancer, ONCOL., 57(Suppl. 1):21-26 (1999),
`
`Bates numbered AMGKAN02741850 – AMGKAN02741855.
`
`10.
`
`Attached hereto as Exhibit 8 is a true and correct copy of excerpts from Perry (Ed.),
`
`The Chemotherapy Source Book
`
`(1992), Bates numbered AMGKAN02977031 –
`
`AMGKAN02977092.
`
`11.
`
`Attached hereto as Exhibit 9 is a true and correct copy of an excerpted version of
`
`the Sharon Baughman, Ph.D. Deposition Transcript, dated May 9, 2019. This exhibit is marked
`
`Confidential.
`
`12.
`
`Attached hereto as Exhibit 10 is a true and correct copy of the IPR2017-00804,
`
`Paper No. 83, Final Written Decision, for patent 6,627,196 dated October 3, 2018.
`
`13.
`
`Attached hereto as Exhibit 11 is a true and correct copy of PDUFA Reauthorization
`
`Performance Goals and Procedures Fiscal Years 2018
`
`through 2022, available at
`
`https://www.fda.gov/media/99140/download.
`
`3
`
`
`
`
`
`14.
`
`Attached hereto as Exhibit 12 is a true and correct copy of an Amgen Presentation
`
`entitled
`
`, Bates
`
`numbered AMGKAN02739862 – AMGKAN02739873. This exhibit is marked Confidential.
`
`15.
`
`Attached hereto as Exhibit 13 is a true and correct copy of
`
`
`
`AMGKAN02908380. This exhibit is marked Confidential.
`
`16.
`
`Attached hereto as Exhibit 14 is a true and correct copy of an excerpted version of
`
` Bates numbered AMGKAN02908379 –
`
`the
`
`the
`
`17.
`
`Attached hereto as Exhibit 15 is a true and correct copy of an excerpted version of
`
` This exhibit is marked Confidential.
`
` This exhibit is marked
`
`Confidential.
`
`18.
`
`Attached hereto as Exhibit 16 is a true and correct copy of an excerpted version of
`
`the
`
`the
`
`the
`
`.
`
`19.
`
`Attached hereto as Exhibit 17 is a true and correct copy of an excerpted version of
`
`20.
`
`Attached hereto as Exhibit 18 is a true and correct copy of an excerpted version of
`
`. This exhibit is marked Confidential.
`
`21.
`
`Attached hereto as Exhibit 19 is a true and correct copy of an excerpted version of
`
` This exhibit is marked Confidential.
`
`the May 16, 2019 Hearing Transcript.
`
`22.
`
`Attached hereto as Exhibit 20 is a true and correct copy of
`
`
`
` Bates numbered
`
`GNE-HER_001984581 – GNE-HER_001984582. This exhibit is marked Confidential.
`
`4
`
`
`
`
`
`23.
`
`Attached hereto as Exhibit 21 is a true and correct copy of a
`
`
`
` Bates numbered GNE-HER_002991880. This exhibit is
`
`marked Confidential.
`
`24.
`
`Attached hereto as Exhibit 22 is a true and correct copy of an excerpted version of
`
`the Melissa Abreu Deposition Transcript, dated June 28, 2019. This exhibit is marked
`
`Confidential.
`
`25.
`
`Attached hereto as Exhibit 23 is a true and correct copy of an excerpted version of
`
`the Warner Biddle Deposition Transcript, dated May 22, 2019. This exhibit is marked
`
`Confidential.
`
`26.
`
`Attached hereto as Exhibit 24 is a true and correct copy of Mylan’s OGIVRI Drug
`
`Label dated December 2017, Bates numbered GNE-HER_000960425 – GNE-HER_000960463.
`
`This exhibit is marked Confidential.
`
`27.
`
`Attached hereto as Exhibit 25 is a true and correct copy of an excerpted version of
`
`Biologics and Biosimilars: Balancing Incentives for Innovation:
`
` Hearing Before the
`
`Subcommittee on Courts and Competition Policy of the House Committee on the Judiciary, 111th
`
`Congress (July 14, 2009).
`
`28.
`
`Attached hereto as Exhibit 26 is a true and correct copy of an excerpted version of
`
`the Christy Oliger Deposition Transcript, dated June 14, 2019. This exhibit is marked
`
`Confidential.
`
`29.
`
`Attached hereto as Exhibit 27 is a true and correct copy of a Roche Presentation
`
`entitled “2018 results” London, 31 January 2019, Bates numbered AMGKAN02976736 –
`
`AMGKAN02976813.
`
`5
`
`
`
`
`
`30.
`
`Attached hereto as Exhibit 28 is a true and correct copy of an excerpted version of
`
`Plaintiffs’ Final Infringement Contentions, dated June 10, 2019. This exhibit is marked
`
`Confidential.
`
`31.
`
`Attached hereto as Exhibit 29 is a true and correct copy of an excerpted version
`
`the Steven Shak, M.D. Deposition Transcript, dated May 11, 2019. This exhibit is marked
`
`Confidential.
`
`32.
`
`Attached hereto as Exhibit 30 is a true and correct copy of
`
`, Bates numbered GNE-HER_002874988 – GNE-
`
`HER_002874995. This exhibit is marked Confidential.
`
`33.
`
`Attached hereto as Exhibit 31 is a true and correct copy of
`
`
`
`
`
`, Bates numbered GNE-HER_002746975 – GNE-
`
`HER_002746977. This exhibit is marked Confidential.
`
`34.
`
`Attached hereto as Exhibit 32 is a true and correct copy of an excerpted version of
`
`the Robert Mass, M.D. Deposition Transcript, dated May 30, 2019. This exhibit is marked
`
`Confidential.
`
`35.
`
`Attached hereto as Exhibit 33 is a true and correct copy of Exhibit B to Defendant’s
`
`Second Supplemental Response to Plaintiffs’ Interrogatory No. 3 Invalidity Claim Charts for
`
`Asserted Claims of U.S. Patent No. 6,627,196.
`
`36.
`
`Attached hereto as Exhibit 34 is a true and correct copy of Exhibit C to Defendant’s
`
`Second Supplemental Response to Plaintiffs’ Interrogatory No. 3 Invalidity Claim Charts for
`
`Asserted Claims of U.S. Patent No. 7,371,379.
`
`6
`
`
`
`
`
`37.
`
`Attached hereto as Exhibit 35 is a true and correct copy of Exhibit D to Defendant’s
`
`Second Supplemental Response to Plaintiffs’ Interrogatory No. 3 Invalidity Claim Charts for
`
`Asserted Claims of U.S. Patent No. 10,160,811.
`
`38.
`
`Attached hereto as Exhibit 36 is a true and correct copy of United States Patent
`
`No. 8,309,087, titled “Treatment with Anti-ErbB2 Antibodies,” to Susan D. Hellmann,
`
`(“Hellmann”), Bates numbered AMGKAN02977625 – AMGKAN02977650.
`
`39.
`
`Attached hereto as Exhibit 37 is a true and correct copy of the Trastuzumab
`
`Settlement and License Agreement,
`
`, Bates numbered GNE-HER-
`
`B_000000147 – GNE-HER-B_000000178. This exhibit is marked Confidential.
`
`40.
`
`Attached hereto as Exhibit 38 is a true and correct copy of a Genentech Settlement
`
`Agreement,
`
`, Bates numbered GNE-HER-B_000000001 – GNE-HER-
`
`B_000000077. This exhibit is marked Confidential.
`
`41.
`
`Attached hereto as Exhibit 39 is a true and correct copy of a Genentech Settlement
`
`Agreement,
`
`, Bates numbered GNE-HER-B_000000078 – GNE-HER-
`
`B_000000146. This exhibit is marked Confidential.
`
`42.
`
`Attached hereto as Exhibit 40 is a true and correct copy of the September 1998
`
`Herceptin Label, Bates numbered AMGKAN02731815 – AMGKAN02731816.
`
`I declare under penalty of perjury that the foregoing is true and correct to the best of my
`
`knowledge.
`
`
`
`
`
`
`
`EXECUTED this 15th day of July, 2019.
`
`By: /s/ Alissa M. Wood
` Alissa M. Wood
`
`
`7
`
`
`
`
`
`
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`CERTIFICATE OF SERVICE
`
`I HEREBY CERTIFY that on July 15, 2019, a true and correct copy of the foregoing
`
`DECLARATION OF ALISSA M. WOOD IN SUPPORT OF AMGEN’S COMBINED
`
`OPPOSITION TO GENENTECH’S EMERGENCY MOTIONS FOR A TEMPORARY
`
`RESTRAINING ORDER AND A PRELIMINARY INJUNCTION
`
` was served on the following by electronic mail:
`
`Michael P. Kelly
`Daniel M. Silver
`Alexandra Joyce
`MCCARTER & ENGLISH, LLP
`Renaissance Centre
`405 N. King Street, 8th Floor
`Wilmington, DE 19801
`mkelly@mccarter.com
`dsilver@mccarter.com
`ajoyce@mccarter.com
`
`
`
`
`
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`
`
`
`
`
`
`
`
`
` /s/ Neal C. Belgam
`Neal C. Belgam (No. 2721)
`
`
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`
`
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