Case 1:18-cv-01363-CFC Document 158 Filed 06/24/19 Page 1 of 8 PageID #: 14862
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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. 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.
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`Plaintiff and Counterclaim Defendant,
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`SAMSUNG BIOEPIS CO., LTD.,
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`Defendant and Counterclaim Plaintiff.
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`C.A. No. 17-1407-CFC
`(CONSOLIDATED)
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`C.A. No. 18-924-CFC
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`C.A. No. 18-1363-CFC
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`JOINT STATUS REPORT
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`Pursuant to the Court’s Markman Orders dated June 14, 2019, D.I. 257 in C.A. No. 18-
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`0094 & D.I. 157 in C.A. No. 18-1363, and June 17, 2019, D.I. 402 in C.A. No. 17-407, the
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`parties, by and through their undersigned counsel, jointly and respectfully submit a single Joint
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`Status Report for the three civil actions C.A. No. 17-1407, C.A. No. 18-924, and C.A. No. 18-
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`Case 1:18-cv-01363-CFC Document 158 Filed 06/24/19 Page 2 of 8 PageID #: 14863
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`1363. In the Court’s Markman Orders, it ordered the parties to submit a joint status report
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`“setting forth their proposed process and timing for deciding whether the claim term ‘following
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`fermentation’ [in U.S. Patent No. 8,574,869 (“the ’869 patent”)] can be construed by resort to
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`extrinsic evidence or is invalid for indefiniteness.”
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`The parties conferred telephonically and agreed that the issue should be addressed in all
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`three cases jointly. The parties could not agree on the nature of that process or its timing. Their
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`respective positions are set forth below.
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`I.
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`Genentech’s Position
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`Genentech understands the Court’s order as requesting extrinsic evidence concerning the
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`meaning of “fermentation” and “following fermentation,” which Genentech understands would
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`include expert testimony. While the existing expert declarations address the meaning of
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`“following fermentation,” they were not prepared with the benefit of the Court’s opinion and do
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`not address various of the questions raised by the Court regarding the meaning of certain
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`portions of the written description. In view of the upcoming deadlines for expert discovery,
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`including opening expert reports due in approximately one month on July 26, 2019 in C.A. No.
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`18-924 and C.A. No. 18-1363, Genentech submits that the most efficient course is for the parties
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`to exchange expert reports concerning these matters according to the existing deadlines, which
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`culminate with the close of expert discovery on October 11, 2019 in C.A. No. 18-924 and C.A.
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`No. 18-1363, and for the Court to resolve these issues during the bench trial scheduled for
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`December 9, 2019 in C.A. No. 18-924 and C.A. No. 18-1363, when the parties and witnesses
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`Case 1:18-cv-01363-CFC Document 158 Filed 06/24/19 Page 3 of 8 PageID #: 14864
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`already plan to appear before the Court. The Court’s resolution of the issue in C.A. No. 18-924
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`and C.A. No. 18-1363 would then be binding in C.A. No. 17-1407.1
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`The Defendants’ proposal does not make sense. To begin with, the proposed process is
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`inappropriate. Marshaling extrinsic evidence on the meaning of “fermentation,” addressing the
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`written description’s use of terms like “production cycle” and “production process,” and setting
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`forth the case law and argument concerning definiteness is not appropriately confined to short
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`letter briefs. A motion seeking judgment on this issue would normally allow for twenty-page
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`briefs. Compare D. Del. LR 7.1.3(a)(4). Equally important, the existing record on which
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`Defendants would have the Court rely is insufficient for this purpose. Defendants are free to rely
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`on their existing expert declaration. But because Defendants did not raise the particular issue
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`identified by the Court, 17-1407, D.I. 401 at 16, Genentech did not offer evidence addressing it;
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`Genentech will do so in response to Court’s instruction, 17-1407, D.I. 401 at 20. Finally,
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`Defendants’ proposed schedule will not “guide expert analysis,” as they suggest, as service of the
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`opening and responsive expert reports in the Herceptin actions will already be complete before
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`the letter briefs are filed and the Court’s ruling is obtained.
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`II.
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`Amgen’s and Samsung Bioepis’ Position
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`The Court has found that it “cannot construe the term [‘following fermentation’] based on
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`the intrinsic evidence, and therefore, will convene a hearing to determine whether ‘following
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`fermentation’ can be construed by resorting to extrinsic evidence or whether it should be found
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`invalid for indefiniteness.” C.A. No. 17-1407, D.I. 401 (Memorandum Opinion) at 20-21.
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`Amgen and Samsung set forth below their “proposed process and timing for deciding whether
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`1 The alleged indefiniteness of the Kao patent was not raised by Amgen during the exchange of
`contentions pursuant to the BPCIA in 17-1407. Genentech maintains that such allegations are
`not properly the subject of the 17-1407 litigation.
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`Case 1:18-cv-01363-CFC Document 158 Filed 06/24/19 Page 4 of 8 PageID #: 14865
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`the claim term ‘following fermentation’ can be construed by resort to extrinsic evidence or is
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`invalid for indefiniteness.” C.A. No. 17-1407, D.I. 402 (Claim Construction Order).
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`The Court has previously received a fulsome record including expert declarations, expert
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`deposition testimony, and additional extrinsic evidence for construction of “following
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`fermentation” during claim construction proceedings. Genentech’s assertion above that the
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`existing record is insufficient to resolve the issue is belied by the evidence. Genentech has not
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`specified any non-cumulative extrinsic evidence that it believes the Court should consider at this
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`time, or why any such evidence was not submitted as part of the claim construction process.
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`Amgen and Samsung therefore propose that the Court complete its claim construction decision
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`for “following fermentation,” based on the current evidentiary record, after receiving letter
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`briefing from the parties focused on the questions the Court posed in its claim construction
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`Memorandum Opinion, as well as argument at the hearing the Court will convene for this
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`dispute.
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`The proposed letter briefing process and timing is:
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` September 13, 2019 – Amgen and Samsung file opening 3-page letter brief
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` September 20, 2019 – Genentech files responsive 4-page letter brief
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` September 25, 2019 – Amgen and Samsung file reply 2-page letter brief
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` The Court convenes a two hour hearing for argument at its convenience during
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`the week of September 30, 2019 or as soon as practicable afterwards.
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`Genentech’s proposal that the Court hold a full evidentiary hearing with live expert
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`witness testimony to resolve this claim construction and indefiniteness issue is unnecessarily
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`duplicative of the record already before the Court and would waste judicial and party resources.
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`Genentech did not raise any need for live testimony for the initial claim construction hearing, and
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`Case 1:18-cv-01363-CFC Document 158 Filed 06/24/19 Page 5 of 8 PageID #: 14866
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`none is needed for this hearing either, especially since deposition testimony on these issues is
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`already in the record. Furthermore, delaying the hearing until the scheduled bench trial in
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`December 2019 would squander the opportunity to streamline the case if the Court finds the term
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`indefinite (thereby invalidating all asserted claims in the patent). Even if the Court does not find
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`the term is indefinite, its construction would guide expert analysis and trial testimony.
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`Amgen and Samsung respectfully submit that the Court should adopt their proposal for
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`reasons of efficiency and simplification of the case.
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`Respectfully submitted,
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`Genentech v. Amgen, C.A. No. 17-1407-CFC:
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`MCCARTER & ENGLISH, LLP
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`/s/ Daniel M. Silver
`Michael P. Kelly (#2295)
`Daniel M. Silver (#4758)
`Alexandra M. Joyce (#6423)
`Renaissance Centre
`405 N. King Street, 8th Floor
`Wilmington, DE 19801
`(302) 984-6300
`mkelly@mccarter.com
`dsilver@mccarter.com
`ajoyce@mccarter.com
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`OF COUNSEL:
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`Paul B. Gaffney
`David I. Berl
`Thomas S. Fletcher
`Teagan J. Gregory
`Jonathan S. Sidhu
`Williams & Connolly LLP
`725 Twelfth St. NW
`Washington, DC 20005
`(202) 434-5000
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`YOUNG CONAWAY STARGATT & TAYLOR, LLP
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`/s/ James L. Higgins
`Melanie K. Sharp (No. 2501)
`James L. Higgins (No. 5021)
`1000 North King Street
`Wilmington, DE 19801
`(302) 571-6600
`msharp@ycst.com
`jhiggins@ycst.com
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`Attorneys for Amgen Inc.
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`Case 1:18-cv-01363-CFC Document 158 Filed 06/24/19 Page 6 of 8 PageID #: 14867
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`Attorneys for Plaintiff
`Genentech, Inc.
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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
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`Genentech v. Samsung Bioepis Co., Ltd., C.A.
`No. 18-1363-CFC:
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`POTTER ANDERSON & CORROON LLP
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`/s/ Stephanie E. O’Byrne
`David E. Moore (#3983)
`Bindu A. Palapura (#5370)
`Stephanie E. O’Byrne (#4446)
`Hercules Plaza, 6th Floor
`1313 N. Market Street
`Wilmington, DE 19801
`Tel: (302) 984-6000
`dmoore@potteranderson.com
`bpalapura@potteranderson.com
`sobyrne@potteranderson.com
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`Attorneys for Defendant Samsung Bioepis Co.,
`Ltd.
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`Of Counsel:
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`Dimitrios T. Drivas
`Scott T. Weingaertner
`Amit H. Thakore
`John Padro
`Holly Tao
`WHITE &CASE LLP
`1221 Avenue of the Americas
`New York, New York 10020-1095
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`RICHARDS, LAYTON & FINGER, P.A.
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`/s/ Jason J. Rawnsley
`Frederick L. Cottrell, III (#2555)
`Jason J. Rawnsley (#5379)
`Alexandra M. Ewing (#6407)
`920 North King Street
`Wilmington, DE 19801
`(302) 651-7700
`cottrell@rlf.com
`rawnsley@rlf.com
`ewing@rlf.com
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`Of Counsel:
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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
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`Case 1:18-cv-01363-CFC Document 158 Filed 06/24/19 Page 7 of 8 PageID #: 14868
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`Tel: (212) 819-8200
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`kevin.prussia@wilmerhale.com
`andrew.danford@wilmerhale.com
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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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`Daralyn J. Durie
`Adam R. Brausa
`DURIE TANGRI LLP
`217 Leidesdorff St.
`San Francisco, CA 94111
`(415) 362-6666
`ddurie@durietangri.com
`abrausa@durietangri.com
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`Counsel for Plaintiff Genentech, Inc.
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`Genentech v. Amgen, C.A. No. 18-924-CFC:
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`MCCARTER & ENGLISH, LLP
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`/s/ Daniel M. Silver
`Michael P. Kelly (#2295)
`Daniel M. Silver (#4758)
`Alexandra M. Joyce (#6423)
`Renaissance Centre
`405 North King Street, 8th Floor
`Wilmington, DE 19801
`(302) 984-6300
`mkelly@mccarter.com
`dsilver@mccarter.com
`ajoyce@mccarter.com
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`SMITH KATZENSTEIN & JENKINS LLP
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`/s/ Eve H. Ormerod
`Neal C. Belgam (#2721)
`Eve H. Ormerod (#5369)
`1000 West Street, Suite 1501
`Wilmington, DE 19801
`(302) 652-8400
`nbelgam@skjlaw.com
`eormerod@skjlaw.com
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`Case 1:18-cv-01363-CFC Document 158 Filed 06/24/19 Page 8 of 8 PageID #: 14869
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`Of Counsel:
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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
`(617) 526-6000
`william.lee@wilmerhale.com
`lisa.pirozzolo@wilmerhale.com
`emily.whelan@wilmerhale.com
`kevin.prussia@wilmerhale.com
`andrew.danford@wilmerhale.com
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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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`Daralyn J. Durie
`Adam R. Brausa
`DURIE TANGRI LLP
`217 Leidesdorff St.
`San Francisco, CA 94111
`(415) 362-6666
`ddurie@durietangri.com
`abrausa@durietangri.com
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`Attorneys for Plaintiffs Genentech, Inc. and
`City of Hope
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`Of Counsel:
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`Michelle Rhyu
`Susan Krumplitsch
`Daniel Knauss
`COOLEY LLP
`3175 Hanover Street
`Palo Alto, CA 94304-1130
`(650) 843-5287
`skrumplitsch@cooley.com
`mrhyu@cooley.com
`dknauss@cooley.com
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`Orion Armon
`COOLEY LLP
`380 Interlocken Crescent, Suite 900
`Broomfield, CO 80021-8023
`(720) 566-4119
`oarmon@cooley.com
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`Eamonn Gardner
`COOLEY LLP
`4401 Eastgate Mall
`San Diego, CA 92121-1909
`(858) 550-6086
`egardner@cooley.com
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`Nancy Gettel
`Thomas Lavery, IV
`AMGEN INC.
`One Amgen Center Drive
`Thousand Oaks, CA 91320-1799
`(805) 447-1000
`ngettel@amgen.com
`tlavery@amgen.com
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`Attorneys for Defendant Amgen Inc.
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`Dated: June 24, 2019
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