Case 1:18-cv-00924-CFC Document 327 Filed 07/25/19 Page 1 of 7 PageID #: 25727
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
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`GENENTECH, INC. and CITY OF HOPE,
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`v.
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`AMGEN, INC.,
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`Plaintiffs,
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`Defendant.
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`C.A. No. 18-924-CFC
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`REPLY DECLARATION OF CHRISTY OLIGER IN SUPPORT OF
`GENENTECH’S MOTION FOR TEMPORARY RESTRAINING ORDER
`AND PRELIMINARY INJUNCTION
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`PUBLIC VERSION FILED: July 25, 2019
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`
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`
`GENENTECH, INC. and CITY OF HOPE,
`
`v.
`
`AMGEN, INC.,
`
`Plaintiffs,
`
`Defendant.
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`C.A. No. 18-924-CFC
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`
`
`REPLY DECLARATION OF CHRISTY OLIGER IN SUPPORT OF
`GENENTECH’S MOTION FOR TEMPORARY RESTRAINING ORDER
`AND PRELIMINARY INJUNCTION
`
`PUBLIC VERSION FILED: July 25, 2019
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`
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`Case 1:18-cv-00924-CFC Document 327 Filed 07/25/19 Page 2 of 7 PageID #: 25728
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`1.
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`2.
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`I.
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`3.
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`4.
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`5.
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`6.
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`My name is Christy Oliger. I am employed by Genentech, Inc. as Senior Vice President
`of BioOncology, in which role I manage the company’s United States commercial
`operations for its oncology products. I submitted a declaration dated July 10, 2019 in
`support of Genentech’s emergency motion for a temporary restraining order and a
`preliminary injunction.
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`I make this declaration to address certain points in Amgen’s Opposition to Genentech’s
`motion.
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`FORECASTED IMPACT OF AMGEN’S BIOSIMILAR TRASTUZUMAB ON
`HERCEPTIN REVENUES
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`I understand that in its Opposition, Amgen asserts that “
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`” and that as support for
`this assertion, Amgen relies in part on my deposition testimony. Amgen’s assertion is
`mistaken in several respects.
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`During my deposition, I was asked about a document titled “
`”).1 In particular, I
`,” labeled GNE-HER_002948730-70 (“
`was asked about the page labeled GNE-HER_002948733, which refers to a forecasted
`.2
`loss of Herceptin revenue in 2019 of
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`For the reasons explained in my original Declaration, forecasting the potential impact of
`biosimilar trastuzumab on Herceptin revenues and market share, as well as those of other
`Genentech products, involves numerous complex variables and a high degree of
`uncertainty.3 Accordingly, Genentech’s forecasts regarding the potential impact of
`biosimilar trastuzumab are essentially “best guesses.”
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`1 This document was cited as Exhibit 52 in my Declaration in Support of Genentech’s Motion for
`Preliminary Injunction (“original Declaration”).
`2 Ex. 241 [Oliger Dep. Tr.] at 107-11.
`3 Original Declaration § V.
`4 Original Declaration ¶¶ 36-37, 44, 46.
`5 Ex. 52 at GNE-HER_002948751.
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`Case 1:18-cv-00924-CFC Document 327 Filed 07/25/19 Page 3 of 7 PageID #: 25729
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` Instead, Genentech has not increased the price of Herceptin at all in 2019,
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`Amgen’s suggestion that the
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` figure shown in the
`represents a definitive expectation of quantifiable harm is also mistaken. In addition to
`the fact that Genentech’s forecasts are simply highly variable best guesses, Amgen’s
`introduction of Kanjinti will have far-reaching effects that will are likely to change the
`dynamics of the entire oncology biologics market. Accordingly, as discussed in my
`original Declaration,
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`Amgen also misunderstands my deposition testimony regarding the forecast of the impact
`of biosimilar trastuzumab in 2019 being
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`Amgen, a traditional innovator with extensive biologics experience and well-
`established relationships with clinics and payers.
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`POTENTIAL IMPACT OF AMGEN’S BIOSIMILAR TRASTUZUMAB ON
`OTHER GENENTECH PRODUCTS
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`I understand that Amgen also asserts that the potential impact of Kanjinti on other
`Genentech products, such as Perjeta, Kadcyla, Avastin, and Rituxan, should be
`disregarded because
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`7.
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`8.
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`9.
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`II.
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`10.
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`6 Original Declaration ¶¶ 41, 47-48, 50, 53-54, 76.
`7 Ex. 52 at GNE-HER_002948753.
`8 Original Declaration §§ V-VII.
`9 During my deposition, Amgen’s counsel did not ask me when I expected biosimilar
`trastuzumab competition to begin.
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`Case 1:18-cv-00924-CFC Document 327 Filed 07/25/19 Page 4 of 7 PageID #: 25730
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`11.
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`In my original Declaration, I discussed several reasons that biosimilar trastuzumab is
`likely to adversely affect Genentech’s sales of those other products.10
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`12.
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`III.
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`13.
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`14.
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`These considerations do not lend themselves to forecasting, especially in light of their
`interrelated nature, the numerous variables involved in forecasting discussed in my
`original Declaration, and Genentech’s lack of information regarding the price at which
`Amgen will offer Kanjinti.11 Nevertheless, Amgen’s suggestion that
`12 and for the reasons
`discussed in my original Declaration, the launch of biosimilar trastuzumab—especially
`by Amgen, in light of its relationships and experience—is likely to have a pronounced
`adverse effect on these other Genentech products.13
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`POTENTIAL IMPACT OF AMGEN’S BIOSIMILAR TRASTUZUMAB ON
`GENENTECH SPENDING
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`I understand that Amgen also asserts that the launch of Kanjinti will not force Genentech
`to reduce staff, or to reduce research and development (“R&D”) expenditures.
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`IV.
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`POTENTIAL IMPACT OF AMGEN’S BIOSIMILAR TRASTUZUMAB ON
`GENENTECH’S REPUTATION AND GOODWILL
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`15.
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`I understand that Amgen also asserts that the launch of Kanjinti will not adversely affect
`Genentech’s reputation and goodwill
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`10 Original Declaration §§ III, VI.B.
`11 Original Declaration § V.
`12 Original Declaration ¶¶ 59, 61 (citing Ex. 53 at GNE-HER_001378974-75).
`13 Original Declaration §§ VI.B.
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`Case 1:18-cv-00924-CFC Document 327 Filed 07/25/19 Page 5 of 7 PageID #: 25731
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`16.
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`14 Original Declaration ¶ 67.
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`Case 1:18-cv-00924-CFC Document 327 Filed 07/25/19 Page 6 of 7 PageID #: 25732
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`CERTIFICATE OF SERVICE
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`The undersigned counsel hereby certifies that true and correct copies of the foregoing
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`document were caused to be served on July 16, 2019 on the following counsel in the manner
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`indicated:
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`VIA EMAIL:
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`Neal C. Belgam
`Eve H. Ormerod
`Jennifer M. Rutter
`SMITH, KATZENSTEIN & JENKINS, LLP
`1000 West Street, Suite 1501
`Wilmington, DE 19801
`(302) 652-8400
`nbelgam@skjlaw.com
`eormerod@skjlaw.com
`jrutter@skjlaw.com
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`Orion Armon
`COOLEY, LLP
`380 Interlocken Crescent, Suite 900
`Broomfield, CO 80021-8023
`(720) 566-4119
`oarmon@cooley.com
`
`
`Eamonn Gardner
`COOLEY, LLP
`4401 Eastgate Mall
`San Diego, CA 92121-1909
`(858) 550-6086
`egardner@cooley.com
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`ME1 30942553v.1
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`
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`Case 1:18-cv-00924-CFC Document 327 Filed 07/25/19 Page 7 of 7 PageID #: 25733
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`
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`Michelle Rhyu
`Susan Krumplitsch
`Daniel Knauss
`Philip H. Mao
`Alexandra Leeper
`Lauren Krickl
`Benjamin S. Lin
`Alissa M. Wood
`COOLEY, LLP
`3175 Hanover Street
`Palo Alto, CA 94304-1130
`(650) 843-5287
`rhyums@cooley.com
`skrumplitsch@cooley.com
`dknauss@cooley.com
`pmao@cooley.com
`aleeper@cooley.com
`lkrickl@cooley.com
`blin@cooley.com
`amwood@cooley.com
`
`Nancy Gettel
`Brian Kao
`Lois Kwasigroch
`AMGEN, INC.
`One Amgen Center Drive
`Thousand Oaks, CA 91320-1799
`(805) 447-1000
`ngettel@amgen.com
`bkao@amgen.com
`loisk@amgen.com
`
`Xiaoxiao Xue
`1299 Pennsylvania Avenue, NW, Suite 700
`Washington, DC 20004-2400
`(202) 842-7809
`xxue@cooley.com
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`Attorneys for Defendant Amgen Inc.
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`Dated: July 16, 2019
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`/s/ Michael P. Kelly
`Michael P. Kelly (#2295)
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`ME1 30942553v.1
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`2
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