Case 1:18-cv-00924-CFC Document 416 Filed 10/14/19 Page 1 of 8 PageID #: 31454
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`C.A. No. 17-1407-CFC
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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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`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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`AMGEN INC.,
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`Defendant and
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`C.A. No. 18-924-CFC
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`GENENTECH’S LETTER-BRIEF CONCERNING
`CONSTRUCTION OF “FOLLOWING FERMENTATION”
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`ME1 31636159v.1
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`PUBLIC VERSION FILED:
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`October 14, 2019
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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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`)
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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 CONCERNING
`CONSTRUCTION OF “FOLLOWING FERMENTATION”
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`ME1 31636159v.1
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`PUBLIC VERSION FILED:
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`October 14, 2019
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`Case 1:18-cv-00924-CFC Document 416 Filed 10/14/19 Page 2 of 8 PageID #: 31455
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`The Kao patent’s claimed methods improve antibody manufacturing
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`processes by adding a step “following fermentation,” a term Genentech proposes to
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`construe as “after the end of the cell growth and antibody production phases
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`(which is indicated by a change in the cell culture environment that substantially
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`ends cell growth and antibody production).” The Court observed correctly that
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`construction of this term involves two questions: (1) what is fermentation; and (2)
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`when does it end? D.I. 401 at 16. The patent provides the POSA clear answers to
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`both questions. Genentech’s construction is therefore definite.
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`1.
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`Kao describes how cells are grown and used to produce antibody
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`proteins. Kao at 25:43-26:41. The next line describes steps taken “Following
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`fermentation . . .,” indicating that the preceding activities are “fermentation.” In
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`the examples, Kao describes a small-scale “fermentation process” during which
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`cells were grown to produce antibodies. Kao at 48:30-41. And in the background,
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`Kao describes preparing cells to “undergo fermentation” in a container where
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`parameters are controlled to ensure “optimal growth and production conditions.”
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`Kao at 1:54-63.
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`Kao’s use of “fermentation” is consistent with the term’s ordinary meaning.
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`In the biotechnology context, “fermentation” refers to the growth of cells and the
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`production (manufacture) by those cells of a product. Hauser ¶ 53; Appx220
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`(Webster’s 3d) (“any of various controlled aerobic or anaerobic processes used for
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`Case 1:18-cv-00924-CFC Document 416 Filed 10/14/19 Page 3 of 8 PageID #: 31456
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`the manufacture of certain products . . .”). FDA defines “fermentation” as a
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`“bioprocess” and notes that “[t]he fermentation process is used also in the
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`production of monoclonal antibodies.” Appx227.
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`The scientific literature confirms this usage. Dr. Hauser identifies several
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`publications using “fermentation” to describe a process for growing cells to
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`produce proteins—its ordinary meaning in the antibody context to the POSA and
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`to Amgen’s prior expert, whom Amgen replaced after he acknowledged that
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`reality. Hauser ¶¶ 54-63; Appx417-418 (Chalmers Tr. 25:15-26:5), Appx421-423
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`(29:14-31:23), Appx440-443 (48:1-51:1).1
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`Amgen also understands “fermentation” in this way. Its 10-K Annual
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`Report explains that “Bulk manufacturing includes fermentation and/or cell
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`culture, processes by which our proteins are produced.” Appx449.
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`.
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`The Court’s opinion asked whether “fermentation” and “production” are
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`synonymous. D.I. 401 at 17-20. They are not, though they are related.
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`“Production” refers to making a product, or it can modify another term to indicate
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`1 The question of whether “fermentation” is limited to the production phase or also
`includes the cell growth phase—when fermentation begins—is irrelevant to
`construing the claimed methods to sparging following fermentation.
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`Case 1:18-cv-00924-CFC Document 416 Filed 10/14/19 Page 4 of 8 PageID #: 31457
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`a relationship to making a product (e.g., the “production cycle”). Hauser ¶¶ 71-
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`72.2 “Fermentation” results in the production of proteins, but it generally is
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`understood to include the process in which cells grow and produce proteins.
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`2.
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`“Fermentation” ends when the cells stop growing and stop making
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`their product. Genentech proposed that this “is indicated by a change in the cell
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`culture environment that substantially ends cell growth and antibody production.”
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`D.I. 401 at 12. This is consistent with the patent’s disclosure and the POSA’s
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`understanding that phases of the manufacturing process are defined by the imposed
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`conditions, Kao at 1:60-63, 26:34-37, and absent changed conditions, cells will
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`continue fermenting, Hauser ¶ 75. The adverb “substantially” reflects that
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`biological systems, such as a typical culture of 100 trillion cells, cannot be turned
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`“on/off” like a lightbulb. Hauser ¶¶ 82-84. For example, chilling cells to certain
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`temperatures will cease cell growth and antibody production. Hauser ¶¶ 76-78.
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`Cells under such conditions are no longer fermenting, a fact that can be confirmed
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`readily by conducting the patent’s testing of cell growth rate and titer (antibody
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`production). Kao at 48:49-53; Hauser ¶ 82.
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`This construction “inform[s] those skilled in the art about the scope of the
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`invention with reasonable certainty.” Nautilus, Inc. v. Biosig Instruments, Inc.,
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`2 “Production” also is used in “production phase,” which is part of fermentation.
`Hauser ¶ 72.
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`Case 1:18-cv-00924-CFC Document 416 Filed 10/14/19 Page 5 of 8 PageID #: 31458
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`572 U.S. 898, 910 (2014). This standard recognizes that “absolute precision” in
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`language is “unattainable,” and not required. Id. Definiteness requires only what
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`is “reasonable” for the particular technical field. Id. at 910-11. As Dr. Hauser
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`explains, the POSA is “reasonably certain” when fermentation has ended using
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`their experience and the testing described in Kao. Hauser ¶ 82.
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`The Federal Circuit’s decision in Enzo Biochem v. Applera is instructive.
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`599 F.3d 1325, 1336 (Fed. Cir. 2010).3
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` The claims
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`there concerned
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`“hybridization,” the binding of two “nucleic acid” molecules (e.g., DNA). Id. at
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`1333-34. Because the POSA could measure hybridization, the claim was definite:
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`“the binding strength of a DNA strand will depend on the length and sequence of
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`the strand, not on the subjective opinion of the particular chemist performing the
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`hybridization.” Id. at 1336. Claim language that depends upon objective,
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`measurable parameters, like the end of cell growth and antibody production, is
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`definite. Because those parameters can be measured as described in the patent,
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`they are entirely unlike subjective criteria held indefinite in other cases. E.g., D.I.
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`141, HIP, Inc. v. Hormel Foods Corp., No. 18-615-CFC (D. Del. June 24, 2019)
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`(“resembling a pan-fried bacon product”).
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`3 The Federal Circuit continues to cite Enzo post-Nautilus. E.g., Guangdong
`Alison Hi-Tech Co. v. ITC, 2019 WL 4019880, at *4-*6 (Fed. Cir. Aug. 27, 2019).
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`Case 1:18-cv-00924-CFC Document 416 Filed 10/14/19 Page 6 of 8 PageID #: 31459
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`Amgen has suggested that “following fermentation” is indefinite because
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`companies choose to end fermentation in different ways and at different times.
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`Amgen addresses the wrong issue. The claimed methods do not concern how
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`fermentation has ended; they concern whether fermentation has ended. FDA-
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`approved manufacturing processes typically end within a defined time window
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`(e.g., between 13-15 days). Hauser ¶ 80. The operator has discretion to end
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`fermentation within that window. That discretion does not change the fact that
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`whenever the operator chooses to end fermentation, the POSA can ascertain,
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`objectively, that fermentation has stopped. An operator who practices the claimed
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`sparging method after fermentation ends infringes, irrespective of the operator’s
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`subjective intent.
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`Case 1:18-cv-00924-CFC Document 416 Filed 10/14/19 Page 7 of 8 PageID #: 31460
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` Respectfully submitted,
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`/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
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`Attorneys for Plaintiffs Genentech, Inc.
`and City of Hope
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`Dated: September 27, 2019
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`OF COUNSEL:
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`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
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`Attorneys for Plaintiff Genentech, Inc.
`(17-1407-CFC)
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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
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`Case 1:18-cv-00924-CFC Document 416 Filed 10/14/19 Page 8 of 8 PageID #: 31461
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`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
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`Nora Passamaneck
`WILMER CUTLER PICKERING
`HALE AND DORR LLP
`1225 17th Street, Suite 2600
`Denver, CO 80202
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`Attorneys for Plaintiff Genentech, Inc.
`(18-924-CFC)
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`Daralyn J. Durie
`Adam R. Brausa
`Eric C. Wiener
`Eneda Hoxha
`DURIE TANGRI
`271 Leidesdorff Street
`San Francisco, CA 94111
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`Attorneys for Plaintiffs Genentech,
`Inc. and City of Hope
`(17-1407-CFC and 18-924-CFC)
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`ME1 31636159v.1
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