Case 1:18-cv-00924-CFC-SRF Document 452 Filed 11/01/19 Page 1 of 14 PageID #:
`32991
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`C.A. No. 17-1407-CFC
`(CONSOLIDATED)
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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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`Plaintiffs,
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`AMGEN INC.,
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`Defendant.
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`____________________________________)
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`GENENTECH, INC.,
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`Plaintiff and
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`Counterclaim Defendant,
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`AMGEN INC.,
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`Defendant and
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`Counterclaim Plaintiff.
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`____________________________________)
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`C.A. No. 18-924-CFC
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`GENENTECH’S LETTER-BRIEF ADDRESSING
`THE COURT’S POST-HEARING QUESTIONS
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`ME1 31802308v.1
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`32991
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`C.A. No. 17-1407-CFC
`(CONSOLIDATED)
`
`
`
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`
`GENENTECH, INC. and CITY OF HOPE, )
`
`
`
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`)
`Plaintiffs,
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`v.
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`AMGEN INC.,
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`Defendant.
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`)
`____________________________________)
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`GENENTECH, INC.,
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`Plaintiff and
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`Counterclaim Defendant,
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`v.
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`AMGEN INC.,
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`Defendant and
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`)
`
`Counterclaim Plaintiff.
`
`
`)
`____________________________________)
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`
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`C.A. No. 18-924-CFC
`
`GENENTECH’S LETTER-BRIEF ADDRESSING
`THE COURT’S POST-HEARING QUESTIONS
`
`
`
`ME1 31802308v.1
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`Case 1:18-cv-00924-CFC-SRF Document 452 Filed 11/01/19 Page 2 of 14 PageID #:
`32992
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`
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`I.
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`The First Step of Harvesting
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`“Harvest” is the process of separating the culture fluid (which contains the
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`antibody) from cells or cellular debris. Kao at 2:1-5; No. 18-1363, D.I. 81 ¶¶ 42-
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`43 & Ex. 6 at 301-02. Amgen appears to agree with this understanding of harvest.
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`See No. 1407, D.I. 325 at 61.1
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`The “first step” in harvest therefore is the first step in the process of
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`separating the antibody from cells and debris; its exact nature will depend upon
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`how a company implements its manufacturing process. The antibody
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`manufacturing process depicted in Figure 3 in the Birch paper from Lonza shows,
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`in the second row, centrifugation as the first step in the harvest process. No. 1407,
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`D.I. 516 at Appx213. The Kao patent’s examples likewise involve centrifugation
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`followed by filtration, Kao at 48:61-49:3, and the written description deems this
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`sequence of harvest operations typical, id. at 2:3-4; see also 4/24/19 Markman Hrg.
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`Tr. at 60:1-21. But other harvest implementations may separate the antibody from
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`cells and debris using a first step other than centrifugation. Kao states that
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`“harvesting by centrifugation, filtration or similar separation methods” can be
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`used, Kao at 22:4-5 (emphasis added), and the review paper cited in Kao suggested
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`harvesting by filtration or centrifugation, No. 18-1363, D.I. 81, Ex. 6 at 301-02.
`
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`1 The parties also agree that “harvest” is used synonymously with “recovery” in
`Kao. See 4/24/19 Markman Hrg. Tr. at 57:18-58:11.
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`ME1 31802308v.1
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`Case 1:18-cv-00924-CFC-SRF Document 452 Filed 11/01/19 Page 3 of 14 PageID #:
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`Thus, while centrifugation typically is the first step, there is no universal first step
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`for every process of separating the antibody-containing culture fluid from the cells.
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`However, given a particular manufacturing process, the POSA readily could
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`determine the first step of harvest in that process.
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`All of the previous examples involve mammalian cells in which the antibody
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`was secreted by the cells into the culture fluid. Other cells, for example bacteria,
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`typically do not secrete proteins, so it is necessary to “lyse,” or rupture, the cells to
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`release any antibody trapped inside. Kao at 28:40-52. Depending upon the
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`technique used (enzymatic treatment, osmotic shock, mechanical shear, etc., see
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`Kao at 26:47-49), lysis may occur inside or outside of the bioreactor. After lysis,
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`antibody expressed by bacterial cells may be harvested, including by the
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`techniques discussed above. No. 1407, D.I. 325 at 62.
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`Whether the antibody is expressed in mammalian or bacterial cells, the
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`patent is clear that harvest occurs after (but not necessarily immediately after2) the
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`end of antibody production. See Kao at 25:40-42.
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`II.
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`“Pre-Harvest Culture Fluid”
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` “Pre-harvest culture fluid” was a disputed term in the Genentech/Samsung
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`Bioepis Herceptin litigation. The parties agreed during the Markman argument
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`2 As discussed below, a manufacturer can take steps to prepare to harvest after
`fermentation. Amgen agrees that harvest does not need to occur immediately after
`fermentation. See No. 1407, D.I. 325 at 61-62.
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`Case 1:18-cv-00924-CFC-SRF Document 452 Filed 11/01/19 Page 4 of 14 PageID #:
`32994
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`that its plain and ordinary meaning would suffice, No. 18-1363, D.I. 182 at 90, and
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`the Court entered that construction, No. 18-1363, D.I. 257 at 2.
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`The plain and ordinary meaning of “pre-harvest culture fluid” is culture fluid
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`that will be harvested. Kao explains how disulfide bond reduction can be inhibited
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`by applying sparging “following completion of the cell culture processes,
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`preferably to CCF [cell culture fluid] prior to harvest . . . .” Kao at 23:54-58. The
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`“CCF prior to harvest” is pre-harvest culture fluid—culture fluid that will be
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`harvested.
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`Kao’s prosecution history reinforces that “pre-harvest” culture fluid is fluid
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`that will be harvested. The Examiner issued a rejection over “Reeves,” a reference
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`disclosing sparging the bioreactor before harvest to support cell growth. No. 18-
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`1363, D.I. 81 ¶¶ 62-63. Genentech did not dispute the Examiner’s conclusion that
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`Reeves disclosed sparging of “pre-harvest” culture fluid; rather, it responded by
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`adding the “following fermentation” limitation to clarify that the claims concerned
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`sparging at a different point in manufacturing.
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`“Following fermentation” thus limits when the claimed sparging occurs. It
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`does not limit where the claimed sparging takes place. In some processes steps are
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`taken in the bioreactor to prepare for harvest, e.g., chilling the culture fluid. As
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`shown below, if antibody production has ended at this juncture, any sparging in the
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`bioreactor will be both “pre-harvest” and “following fermentation.”
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`Case 1:18-cv-00924-CFC-SRF Document 452 Filed 11/01/19 Page 5 of 14 PageID #:
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`In other cases, the manufacturer may choose to proceed immediately to harvest at
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`the end of fermentation.3
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`The POSA has no trouble understanding the meaning of “pre-harvest.”
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`confirms that the POSA could understand “pre-harvest” culture fluid with the
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`3 Though “pre-harvest” is a temporal rather than spatial limitation, the pre-harvest
`culture fluid, following fermentation, typically is located between the bioreactor
`and the centrifuge (inclusive of both locations). Dr. Hauser’s testimony that the
`pre-harvest fluid in Figure 3 of Birch is the material between “the tank” and the
`centrifuge reflects this. See 10/16/19 Hrg. Tr. at 112:11-18.
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`Case 1:18-cv-00924-CFC-SRF Document 452 Filed 11/01/19 Page 6 of 14 PageID #:
`32996
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`reasonable certainty required by Nautilus. See Sonix Tech. Co. v. Publications
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`Int’l, Ltd., 844 F.3d 1370, 1380 (Fed. Cir. 2017).4
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`“Pre-harvest” culture fluid thus has a definite plain and ordinary meaning.
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`To the extent the Court is inclined to reconsider its prior decision to adopt plain
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`and ordinary meaning as the construction, Genentech requests an opportunity to
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`submit additional evidence.
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` Respectfully submitted,
`
`
`
`Dated: October 25, 2019
`
`
`
`OF COUNSEL:
`
`Paul B. Gaffney
`David I. Berl
`Thomas S. Fletcher
`Kyle E. Thomason
`Teagan J. Gregory
`Charles L. McCloud
`Kathryn S. Kayali
`WILLIAMS & CONNOLLY LLP
`725 Twelfth St. NW
`Washington, DC 20005
`(202) 434-5000
`
`Attorneys for Plaintiff Genentech, Inc.
`(17-1407-CFC)
`
`/s/ Daniel M. Silver
`
`Michael P. Kelly (# 2295)
`Daniel M. Silver (# 4758)
`Alexandra M. Joyce (# 6423)
`MCCARTER & ENGLISH, LLP
`Renaissance Centre
`405 N. King Street, 8th Floor
`Wilmington, Delaware 19801
`Tel.: (302) 984-6300
`Fax: (302) 984-6399
`mkelly@mccarter.com
`dsilver@mccarter.com
`ajoyce@mccarter.com
`
`Attorneys for Plaintiffs Genentech, Inc.
`and City of Hope
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`4
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`ME1 31802308v.1
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`5
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`Case 1:18-cv-00924-CFC-SRF Document 452 Filed 11/01/19 Page 7 of 14 PageID #:
`32997
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`William F. Lee
`Lisa J. Pirozzolo
`Emily R. Whelan
`Kevin S. Prussia
`Andrew J. Danford
`WILMER CUTLER PICKERING
`HALE AND DORR LLP
`60 State Street
`Boston, MA 02109
`(627) 526-6000
`william.lee@wilmerhale.com
`lisa.pirozzolo@wilmerhale.com
`emily.whelan@wilmerhale.com
`andrew.danford@wilmerhale.com
`
`Robert J. Gunther Jr.
`WILMER CUTLER PICKERING
`HALE AND DORR LLP
`7 World Trade Center
`250 Greenwich Street
`New York, NY 10007
`(212) 230-8800
`robert.gunther@wilmerhale.com
`
`Nora Passamaneck
`WILMER CUTLER PICKERING
`HALE AND DORR LLP
`1225 17th Street, Suite 2600
`Denver, CO 80202
`
`Daralyn J. Durie
`Adam R. Brausa
`Eric C. Wiener
`Eneda Hoxha
`DURIE TANGRI
`271 Leidesdorff Street
`San Francisco, CA 94111
`
`Attorneys for Plaintiffs Genentech,
`Inc. and City of Hope
`
`
`ME1 31802308v.1
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`6
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`
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`Case 1:18-cv-00924-CFC-SRF Document 452 Filed 11/01/19 Page 8 of 14 PageID #:
`32998
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`
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`(17-1407-CFC and 18-924-CFC)
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`ME1 31802308v.1
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`7
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`Case 1:18-cv-00924-CFC-SRF Document 452 Filed 11/01/19 Page 9 of 14 PageID #:
`32999
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`
`
`C.A. No. 17-1407-CFC
`(CONSOLIDATED)
`
`
`C.A. No. 18-924-CFC
`
`
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`
`GENENTECH, INC. and CITY OF HOPE, )
`
`
`
`
`
`
`
`)
`Plaintiffs,
`
`
`
`
`
`)
`
`
`
`
`
`
`
`)
`
`v.
`
`
`
`
`
`)
`
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`
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`
`)
`AMGEN INC.,
`
`
`
`
`)
`
`
`
`
`
`
`
`)
`Defendant.
`
`
`
`
`)
`____________________________________)
`
`
`
`
`
`
`
`)
`GENENTECH, INC.,
`
`
`
`)
`
`
`
`
`
`
`
`)
`Plaintiff and
`
`
`
`
`)
`
`Counterclaim Defendant,
`
`)
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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.
`
`
`
`)
`____________________________________)
`
`WORD COUNT CERTIFICATION
`
`The undersigned counsel hereby certifies that Genentech, Inc.’s Letter-Brief
`
`
`
`Addressing The Court’s Post-Hearing Questions contains 938 total words, which
`
`were counted by Daniel M. Silver by using the word count feature in Microsoft
`
`Word, in 14-point Times New Roman font. The foregoing word count does not
`
`include the cover page, tables of contents and authorities, or the counsel blocks.
`
`
`
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`ME1 31801732v.1
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`Case 1:18-cv-00924-CFC-SRF Document 452 Filed 11/01/19 Page 10 of 14 PageID
`#: 33000
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`
`
`Dated: October 25, 2019
`
`
`
` Respectfully submitted,
`
`
`
`
`
`
` /s/ Daniel M. Silver
`Michael P. Kelly (# 2295)
`Daniel M. Silver (# 4758)
`Alexandra M. Joyce (# 6423)
`MCCARTER & ENGLISH, LLP
`Renaissance Centre
`405 N. King Street, 8th Floor
`Wilmington, Delaware 19801
`Tel.: (302) 984-6300
`Fax: (302) 984-6399
`mkelly@mccarter.com
`dsilver@mccarter.com
`ajoyce@mccarter.com
`
`Attorneys for Plaintiffs Genentech, Inc.
`and City of Hope
`
`
`
`OF COUNSEL:
`
`Paul B. Gaffney
`David I. Berl
`Thomas S. Fletcher
`Kyle E. Thomason
`Teagan J. Gregory
`Charles L. McCloud
`Kathryn S. Kayali
`WILLIAMS & CONNOLLY LLP
`725 Twelfth St. NW
`Washington, DC 20005
`(202) 434-5000
`
`Attorneys for Plaintiff Genentech, Inc.
`(17-1407-CFC)
`
`William F. Lee
`Lisa J. Pirozzolo
`Emily R. Whelan
`Kevin S. Prussia
`Andrew J. Danford
`WILMER CUTLER PICKERING
`HALE AND DORR LLP
`60 State Street
`Boston, MA 02109
`(627) 526-6000
`william.lee@wilmerhale.com
`lisa.pirozzolo@wilmerhale.com
`emily.whelan@wilmerhale.com
`andrew.danford@wilmerhale.com
`
`
`
`
`
`
`
`ME1 31801732v.1
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`2
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`Case 1:18-cv-00924-CFC-SRF Document 452 Filed 11/01/19 Page 11 of 14 PageID
`#: 33001
`
`
`
`
`Robert J. Gunther Jr.
`WILMER CUTLER PICKERING
`HALE AND DORR LLP
`7 World Trade Center
`250 Greenwich Street
`New York, NY 10007
`(212) 230-8800
`robert.gunther@wilmerhale.com
`
`Nora Passamaneck
`WILMER CUTLER PICKERING
`HALE AND DORR LLP
`1225 17th Street, Suite 2600
`Denver, CO 80202
`
`Daralyn J. Durie
`Adam R. Brausa
`Eric C. Wiener
`Eneda Hoxha
`DURIE TANGRI
`271 Leidesdorff Street
`San Francisco, CA 94111
`
`Attorneys for Plaintiffs Genentech,
`Inc. and City of Hope
`(17-1407-CFC and 18-924-CFC)
`
`
`
`ME1 31801732v.1
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`3
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`Case 1:18-cv-00924-CFC-SRF Document 452 Filed 11/01/19 Page 12 of 14 PageID
`#: 33002
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`CERTIFICATE OF SERVICE
`
`The undersigned counsel hereby certifies that true and correct copies of the
`
`foregoing document were caused to be served on October 25, 2019 on the
`
`following counsel in the manner indicated:
`
`C.A. No. 18-924-CFC
`VIA EMAIL:
`
`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
`
`
`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
`
`
`
`
`
`ME1 31801730v.1
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`Case 1:18-cv-00924-CFC-SRF Document 452 Filed 11/01/19 Page 13 of 14 PageID
`#: 33003
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`
`
`Christopher B. Mead
`London & Mead
`1225 19th Street, NW, Ste. 320
`Washington, DC 20036
`(202) 331-3334
`cmead@londonandmead.com
`
`
`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
`
`Brian Kao
`Lois Kwasigroch
`AMGEN, INC.
`One Amgen Center Drive
`Thousand Oaks, CA 91320-1799
`(805) 447-1000
`bkao@amgen.com
`loisk@amgen.com
`
`Attorneys for Defendant Amgen Inc.
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`
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`ME1 31801730v.1
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`2
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`Case 1:18-cv-00924-CFC-SRF Document 452 Filed 11/01/19 Page 14 of 14 PageID
`#: 33004
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`
`
`C.A. No. 17-1407-CFC
`VIA EMAIL:
`
`Melanie K. Sharp
`James L. Higgins
`YOUNG CONAWAY STARGATT &
`TAYLOR, LLP
`1000 North King Street
`Wilmington, DE 19801
`(302) 571-6600
`msharp@ycst.com
`jhiggins@ycst.com
`
`Steven M. Bauer
`Kimberly A. Mottley
`Gourdin W. Sirles
`PROSKAUER ROSE LLP
`One International Place
`Boston, MA 02110-2600
`(617) 526-9600
`sbauer@proskauer.com
`kmottley@proskauer.com
`gsirles@proskauer.com
`
`Siegmund Y. Gutman
`Amir A. Naini
`David M. Hanna
`Michelle M. Ovanesian
`PROSKAUER ROSE LLP
`2029 Century Park East
`Los Angeles, CA 90067-3206
`(310) 557-2900
`sgutman@proskauer.com
`anaini@proskauer.com
`dhanna@proskauer.com
`movanesian@proskauer.com
`
`Attorneys for Defendant Amgen Inc.
`
`Dated: October 25, 2019
`
`
`
`
`
`
`
`
`
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`
`
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`
`
` /s/ Daniel M. Silver
`Daniel M. Silver (#4758)
`
`
`
`
`ME1 31801730v.1
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`3
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