throbber
Case 1:18-cv-00924-CFC-SRF Document 261 Filed 06/21/19 Page 1 of 46 PageID #:
`18878
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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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`v.
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`AMGEN INC.,
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`Defendant.
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`__________________________________________)
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`
`C.A. No. 18-924-CFC
`(CONSOLIDATED)
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`LETTER FROM DANIEL M. SILVER, ESQ. TO THE
`HONORABLE COLM F. CONNOLLY
`
`MCCARTER & ENGLISH, LLP
`
`Michael P. Kelly (#2295)
`Daniel M. Silver (#4758)
`Alexandra M. Joyce (#6423)
`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
`
`
`Dated: June 13, 2019
`
`OF COUNSEL:
`
`William F. Lee
`Lisa J. Pirozzolo
`Emily R. Whelan
`Kevin S. Prussia
`Andrew J. Danford
`Stephanie Neely
`WILMER CUTLER PICKERING
` HALE AND DORR LLP
`60 State Street
`Boston, MA 02109
`
`Robert J. Gunther, Jr.
`WILMER CUTLER PICKERING
`HALE AND DORR LLP
`7 World Trade Center
`250 Greenwich Street
`New York, NY 10007
`
`Nora Passamaneck
`WILMER CUTLER PICKERING
`HALE AND DORR LLP
`1225 17th Street, Suite 2600
`Denver, CO 80202
`
`
`
`
`ME1 30663949v.1
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`PUBLIC VERSION FILED:
`JUNE 21, 2019
`
`

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`Case 1:18-cv-00924-CFC-SRF Document 261 Filed 06/21/19 Page 2 of 46 PageID #:
`18879
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`
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`Nancy Schroeder
`WILMER CUTLER PICKERING
`HALE AND DORR LLP
`350 S Grand Avenue, Suite 2100
`Los Angeles, CA 90071
`
`Darlyn Durie
`Adam Brausa
`DURIE TANGRI LLP
`217 Leidesdorff Street
`San Francisco, CA 94111
`
`David I. Berl
`Thomas S. Fletcher
`Charles L. McCloud
`Teagan J. Gregory
`WILLIAMS & CONNOLLY LLP
`725 Twelfth St. NW
`Washington, DC 20005
`
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`ME1 30663949v.1
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`2
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`Case 1:18-cv-00924-CFC-SRF Document 261 Filed 06/21/19 Page 3 of 46 PageID #:
`18880
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`Dear Judge Connolly;
`
`I write on behalf of Genentech in C.A. No. 18-cv-924-CFC to request that the Court
`
`compel Amgen to produce documents and make certain witnesses available for deposition
`stemming from Amgen’s decision to waive privilege and rely on the advice of counsel as a
`defense to willful patent infringement. A similar dispute will be presented at the June 18, 2019
`discovery conference in the related Avastin case (C.A. No. 17-cv-1407-CFC), and Genentech
`believes it would be most efficient for the Court to decide this issue in this case at the same time.
`
`Patent infringement is a strict liability offense. See, e.g., Valinge Innovation AB v.
`
`Halstead New England Corp., 2018 WL 2411218, at *3 (D. Del. May 29, 2018). A defendant
`accused of willful patent infringement, however, may seek to avoid enhanced damages by
`alleging that it acted in good faith in reliance on the advice of counsel. See, e.g., Greatbatch Ltd.
`v. AVX Corp., 2016 WL 7217625, at *4-6 (D. Del. Dec. 13, 2016).
`
`
`Reliance on an advice of counsel defense is a waiver of attorney/client privilege that
`extends to other legal advice that the defendant has received on the same subject. See In re
`EchoStar Commc’ns Corp., 448 F.3d 1294, 1299 (Fed. Cir. 2006). This ensures that a defendant
`may not use the attorney/client privilege as both a sword and shield by selectively disclosing
`certain legal advice to advance its interests while withholding other legal advice on the same
`subject matter that would undermine its position. See, e.g., EchoStar, 448 F.3d at 1303; In re
`Seagate Tech., LLC, 497 F.3d 1360, 1372 (Fed. Cir. 2007).
`
`
`
`
`
`
`
` See Exs. 1, 2. This disclosure
`came only ten days before the close of fact discovery and after Amgen had already asserted
`privilege to prevent witnesses from testifying on the same subject matter at their depositions.
`Upon receiving Amgen’s opinion letters, Genentech requested that Amgen produce all legal
`advice that Amgen had received on the subject matter to ensure that Amgen was not selectively
`disclosing only favorable legal advice while shielding unfavorable legal advice from disclosure.
`See Ex. 3 at 1-2. Amgen, however, has refused to fully disclose the other legal advice that
`Amgen has received on the subject matter of these letters (see Ex. 4 at 1) and, to date, has not
`produced anything to Genentech beyond the two opinion letters themselves.
`
`I.
`
`Scope of Waiver
`
`The case law is clear that Amgen’s privilege waiver is not limited to the opinion letters
`themselves but also includes other legal advice that Amgen has received on the same subject.
`See, e.g., EchoStar, 448 F.3d at 1299. Yet Amgen has agreed only to provide “communications
`regarding the opinion letters exchanged between Amgen in-house counsel and outside opinion
`counsel and/or Amgen decision-makers who relied upon the opinions, and any other opinion
`letters obtained by Amgen regarding the invalidity of the [’869] and/or [’196, ’379, and ’811]
`patents.” Ex. 4 at 1. Amgen has refused to provide any other communications relating to the
`opinion letters (including communications between Amgen in-house counsel) or any other legal
`
`ME1 30663949v.1
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`1
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`Case 1:18-cv-00924-CFC-SRF Document 261 Filed 06/21/19 Page 4 of 46 PageID #:
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`advice that Amgen has received on this subject matter. Id. That selective approach to privilege
`waiver is exactly what the law forbids. EchoStar, 448 F.3d at 1303; Seagate, 497 F.3d at 1372.
`
`As a subject matter waiver, Genentech is entitled to receive all legal advice that Amgen
`has received on the same subject matter in order to evaluate Amgen’s state of mind. Genentech
`therefore requests in ¶ 1 of its proposed order that Amgen produce all documents relating to
`assessments of (i) infringement and/or validity of the ’869 patent; and (ii) validity of the ’196,
`’379, and ’811 patents provided to Amgen. The specific categories of information addressed
`below are not meant to be limiting as to the scope of Amgen’s waiver and instead simply
`illustrate the problem with Amgen selectively asserting privilege over certain legal advice while
`affirmatively relying on other legal advice on the same subject matter as a defense to willfulness.
`
`A.
`
`
`
`
`The Herceptin label (which Amgen has copied for its biosimilar product) includes certain
`indications and regimens that are covered by the ’196, ’379, and ’811 patents. The validity of
`the ’196 and ’379 patents was previously challenged in multiple IPRs.
`
`
`
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`
` The PTAB in October 2018 issued final
`written decisions upholding the validity of the ’196 and ’379 patents. The related ’811 patent
`issued on December 25, 2018.
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`See Ex. 1.
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`Amgen has asserted privilege and refuses to disclose the legal advice
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` See Ex. 8. Yet Amgen now seeks to rely on legal advice that those same
`patents are invalid as a willfulness defense. Amgen cannot have it both ways. Genentech
`requests that the Court order Amgen to produce all documents
`
`
`B.
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`.
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`.
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`Amgen has similarly taken an inconsistent approach with respect to assessments of
`infringement for the ’869 patent.
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`ME1 30663949v.1
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`2
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`Case 1:18-cv-00924-CFC-SRF Document 261 Filed 06/21/19 Page 5 of 46 PageID #:
`18882
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`.
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`Id. at 63:16-65:23, 209:17-210:15. But now that Amgen has waived privilege with respect to
`infringement of the ’869 patent, Amgen may not withhold assessments of infringement of that
`patent on privilege grounds. Accordingly, Genentech requests in ¶ 3 of its proposed order that
`Amgen produce all documents
`.
`
`C.
`
`Communications with “trial counsel.”
`
` Amgen’s state of mind in relying on opinions of counsel is necessarily influenced by the
`legal advice that Amgen has received from its own in-house counsel. Amgen has sought to
`exempt its in-house counsel from the scope of the privilege waiver by labeling them as “trial
`counsel.” But that is not a tenable position—especially for any in-house counsel who had a role
`in obtaining the opinion letters or in advising Amgen’s business decisionmakers. The fact that
`an in-house attorney has entered an appearance in the litigation does not place them outside the
`scope of the privilege waiver. See Seagate, 497 F.3d at 1374-75. Communications with and
`among Amgen’s in-house counsel concerning the subject matter addressed in the opinion letters
`should fall within the scope of Amgen’s privilege waiver, as reflected in ¶ 4 of Genentech’s
`proposed order.
`
`
`Amgen has also sought to categorically exclude communications with its outside trial
`
`counsel from disclosure, relying on Seagate. However, this case does not involve the “ordinary
`circumstances” that “depend on an infringer’s prelitigation conduct” that Seagate addressed. 497
`F.3d at 1374. Amgen obtained its opinions of counsel long after this litigation began, and
`Amgen’s reliance on those opinions is colored by the legal advice that Amgen’s business
`decisionmakers have received—directly or indirectly—from Amgen’s outside litigation counsel.
`Genentech is not seeking communications with outside litigation counsel if they solely reflect
`“litigation strategy” or the “manner of presenting a case to a judicial decision maker.” Id. at
`1373. But now that Amgen has placed its current state of mind at issue, Genentech is entitled to
`know what legal advice from Amgen’s outside trial counsel has been presented to Amgen “for
`making informed business decisions,” id., as requested in ¶ 5 of Genentech’s proposed order.
`
`II.
`
`Deposition Discovery
`
`Amgen has sought to limit Genentech to a single 30(b)(6) deposition of in-house counsel
`regarding Amgen’s opinion letters. However, Genentech should not be limited to a corporate
`witness on these issues, particularly if there were many individuals involved in obtaining the
`opinion of counsel. Accordingly, Genentech requests in ¶ 6 of its proposed order that Genentech
`may take depositions of any in-house attorney involved in obtaining the opinion letters.
`
`Amgen has asserted privilege during prior depositions to certain questions falling within
`the scope of its privilege waiver (e.g.,
`
`). See, e.g., Ex. 12 at 10:24-11:7, 50:14-25; Ex. 13 at 210:1-24; Ex. 11 at 63:16-
`65:23; Ex. 14 at 166:5-17, 169:2-10, 170:23-171:3; Ex. 15 at 126:6-127:13, 189:6-191:7, 332:14-
`334:13. Genentech requests in ¶ 7 of its proposed order that Amgen make those witnesses
`available for further deposition now that Amgen has waived privilege over those matters.
`
`ME1 30663949v.1
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`3
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`

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`Case 1:18-cv-00924-CFC-SRF Document 261 Filed 06/21/19 Page 6 of 46 PageID #:
`18883
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`Respectfully submitted,
`
`/s/ Daniel M. Silver
`
`Daniel M. Silver (#4758)
`
`cc:
`
`Counsel of Record (via electronic mail)
`
`ME1 30663949v.1
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`4
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`

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`Case 1:18-cv-00924-CFC-SRF Document 261 Filed 06/21/19 Page 7 of 46 PageID #:
`18884
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`EXHIBIT 1
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`Case 1:18-cv-00924-CFC-SRF Document 261 Filed 06/21/19 Page 8 of 46 PageID #:
`18885
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`Case 1:18-cv-00924-CFC-SRF Document 261 Filed 06/21/19 Page 9 of 46 PageID #:
`18886
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`EXHIBIT 2
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`Case 1:18-cv-00924-CFC-SRF Document 261 Filed 06/21/19 Page 10 of 46 PageID
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`Case 1:18-cv-00924-CFC-SRF Document 261 Filed 06/21/19 Page 11 of 46 PageID
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`EXHIBIT 3
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`Case 1:18-cv-00924-CFC-SRF Document 261 Filed 06/21/19 Page 12 of 46 PageID
`#: 18889
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`
`
`June 3, 2019
`
`Michelle Rhyu
`Eamonn Gardner
`Susan Krumplitsch
`Daniel J. Knauss
`Orion Armon
`Benjamin Lin
`Lauren Krickl
`COOLEY LLP
`
`Andrew J. Danford
`
`+1 617 526 6806 (t)
`+1 617 526 5000 (f)
`andrew.danford@wilmerhale.com
`
`Re: Amgen’s Production of Opinions of Counsel
`
`Counsel,
`
`We have received Amgen’s May 31, 2019 production of two opinions of counsel:
`
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`We were surprised by the timing of this production, given that fact discovery is about to
`close and Amgen has consistently asserted privilege over these matters, including during
`depositions that occurred last week immediately before Amgen chose to disclose these opinions.
`Amgen’s belated decision to waive privilege raises many new issues that will need to be addressed,
`and we are prejudiced by Amgen’s delay in disclosing these opinions until ten days before the
`close of fact discovery.
`
`As an initial matter, Amgen’s production of the opinion letters alone is insufficient. By
`producing these letters, Amgen has waived privilege as to the subject matter of these opinions.
`See In re EchoStar Commc’ns Corp., 448 F.3d 1294 (Fed. Cir. 2006) (waiver extends to “any
`attorney-client communications relating to the same subject matter”). Amgen should have
`produced all documents falling with the scope of Amgen’s privilege waiver at the time that it
`produced the opinion letters. Plaintiffs therefore expect that Amgen will immediately provide the
`following documents:
`
`1. All documents from and correspondence with
`
` regarding these opinions, including any files from opinion counsel and
`correspondence with opinion counsel;
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`2. All underlying documents and drafts of the opinion letters; and
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`

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`Case 1:18-cv-00924-CFC-SRF Document 261 Filed 06/21/19 Page 13 of 46 PageID
`#: 18890
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`Michelle Rhyu
`June 3, 2019
`Page 2
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`
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`3. All documents relating to the subject matter of these opinion letters, including
`communications with and among any in-house counsel at Amgen, and any other
`opinions or advice of counsel given or received relating to the subject matter
`
`Also, as a subject matter waiver, Amgen’s waiver of privilege is not limited to this case.
`
`To the extent that Amgen has received opinions relating to the same subject matter in other
`litigations (e.g., in connection with C.A. 17-cv-1407-CFC), we expect that Amgen will provide
`those opinions to us, as well as any documents encompassed by Amgen’s privilege waiver. We
`also expect that Amgen will withdraw its privilege objections to (1) Plaintiffs’ Request for
`Production Nos. 36, 51, and 92; and (2) Plaintiffs’ 30(b)(6) Topic Nos. 21, 24, 25, 26, 36, 37, 55,
`and 56 in view of its waiver of privilege. To the extent that Amgen has clawed back documents
`relating to the subject matter of Amgen’s waiver (including with respect to Amgen’s label changes
`or efforts to design around the ’869 patent), we expect those documents to be produced to us again.
`
`To the extent that Amgen is withholding or redacting any documents relating to (1) the
`
`validity of U.S. Patent Nos. 6,627,196, 7,371,379, and 10,160,811 or (2) the validity and/or
`infringement of U.S. Patent No. 8,574,869, we expect that Amgen will provide a supplemental
`privilege log identifying all documents being withheld and/or redacted by Amgen through the
`present date so that we can evaluate the scope of Amgen’s privilege waiver. The privilege log
`should include all communications internal to Amgen, as well as with any outside counsel,
`including litigation counsel.
`
`Amgen’s waiver of privilege also affects the scope of the deposition discovery remaining
`in this case. Below are several deposition-related issues that we need to address:
`
`1. Please provide deposition dates for
`. We also intend
`to take depositions of any in-house counsel at Amgen involved in obtaining these
`opinion letters;
`
`2. Amgen has previously asserted privilege and instructed its witnesses not to answer
`questions concerning the subject matter addressed in these opinion letters during
`the following depositions:
`
`d. Amgen’s waiver also affects the deposition testimony
`. We intend to reopen those depositions now that Amgen has
`of
`waived privilege. Please provide their availability to be deposed;
`
`4. Please provide a designee on Plaintiffs’ Rule 30(b)(6) topic 84 relating to
`opinions of counsel; and
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`

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`Case 1:18-cv-00924-CFC-SRF Document 261 Filed 06/21/19 Page 14 of 46 PageID
`#: 18891
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`Michelle Rhyu
`June 3, 2019
`Page 3
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`
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`5. Given that Amgen has not completed its production of documents falling within
`the scope of its privilege waiver, we will hold open
` deposition until
`that production is complete.
`
`We appreciate your prompt attention to these matters. If Amgen will not be providing
`any of what we have outlined above, please let us know your availability on Tuesday, June 4,
`2019 to meet and confer.
`
`Best regards,
`
`Andrew J. Danford
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`Case 1:18-cv-00924-CFC-SRF Document 261 Filed 06/21/19 Page 15 of 46 PageID
`#: 18892
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`EXHIBIT 4
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`Case 1:18-cv-00924-CFC-SRF Document 261 Filed 06/21/19 Page 16 of 46 PageID
`#: 18893
`CONTAINS CONFIDENTIAL INFORMATION SUBJECT TO PROTECTIVE ORDER
`
`
`
`Eamonn Gardner
`+1 858 550 6086
`egardner@cooley.com
`
`
`
`
`June 11, 2019
`
`Andrew Danford
`WILMERHALE
`
`Re: Genentech, Inc. et al. v. Amgen, Inc., Case No. 18-924-CFC (D. Del.) – Discovery regarding
`Opinions of Counsel
`
`Counsel,
`
`This letter is in response to your June 3, 2019 correspondence regarding Amgen’s production of certain
`opinions of counsel. While we disagree with numerous characterizations and assertions raised in your
`letter, we write to address Genentech’s various discovery requests.
`
`
` All documents from and correspondence with
`regarding these opinions, including any files from opinion counsel and correspondence
`with opinion counsel. We will produce all communications with Opinion Counsel
`
` related to the invalidity of the Kao and Baughman patents, and
`any files from Opinion Counsel shared with Amgen.
`
` All underlying documents and drafts of the opinion letter. We will produce all underlying
`documents and drafts of the opinion letters conveyed to Amgen.
`
` All documents relating to the subject matter of these opinion letters, including
`communications with and among any in-house counsel at Amgen, and any other opinions
`or advice of counsel given or received relating to the subject matter. We will produce all
`communications regarding the opinion letters exchanged between Amgen in-house counsel and
`outside opinion counsel and/or Amgen decision-makers who relied upon the opinions, and any
`other opinion letters obtained by Amgen regarding the invalidity of the Kao and/or Baughman
`patents. We will not produce any separate analyses or work product prepared by Amgen’s in-
`house or trial counsel.
`
` Genentech’s request that Amgen withdraw privilege objections to certain requests for
`production, 30(b)(6) topics, and clawed-back documents. Amgen disagrees with any
`suggestion that its production of certain opinions of counsel results in a waiver of all privilege
`objections to the specified RFPs and 30(b)(6) topics. Amgen also disagrees that production of
`certain opinions of counsel somehow waives the separate and unrelated privilege claims for each
`of the clawed-back documents.
`
` Privilege Log. Genentech’s request for a privilege log is unclear. As specified herein, Amgen is
`willing to produce various documents related to Amgen’s reliance on certain opinions of counsel.
`Amgen does not intend to assert any further privilege on those materials. As to any other
`documents, Genentech has no basis for requesting that Amgen provide a privilege log for those
`materials. Moreover, the burden of logging any such materials, especially litigation counsel
`communications, outweighs any benefit here.
`
`
`
`Cooley LLP 4401 Eastgate Mall San Diego, CA 92121
`t: (858) 550-6000 f: (858) 550-6420 cooley.com
`
`

`

`Case 1:18-cv-00924-CFC-SRF Document 261 Filed 06/21/19 Page 17 of 46 PageID
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`June 11, 2019
`Page Two
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` Deposition of
`witnesses.
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`. We will propose deposition dates for these
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` Deposition of Amgen in-house counsel. Amgen will propose deposition dates for one Amgen
`in-house counsel who will provide 30(b)(6) testimony regarding Topic 84 to the extent that topic
`seeks information related to communications with Opinion Counsel.
`
` Depositions of (
`
`We disagree with your characterization of the privilege objections made during these depositions;
`Amgen did not instruct any of these witnesses not to answer questions related to opinions of
`counsel. Moreover, we disagree with any suggestion that Amgen’s production of certain opinions
`of counsel waives the privilege issues raised during any of the depositions. Genentech has no
`basis for seeking additional deposition time for these witnesses.
`
` Plaintiff’s 30(b)(6) Topic 84. As stated above, Amgen will provide a witness who will provide
`30(b)(6) testimony regarding the opinion letters relied upon by Amgen.
`
`
`
`Sincerely,
`
`/s/ Eamonn Gardner
`
`Eamonn Gardner
`
`
`
`
`
`205703399
`
`
`
`Cooley LLP 4401 Eastgate Mall San Diego, CA 92121
`t: (858) 550-6000 f: (858) 550-6420 cooley.com
`
`

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`Case 1:18-cv-00924-CFC-SRF Document 261 Filed 06/21/19 Page 18 of 46 PageID
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`EXHIBIT 5
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`EXHIBIT 6
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`EXHIBIT 7
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`EXHIBIT 8
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`Case 1:18-cv-00924-CFC-SRF Document 261 Filed 06/21/19 Page 26 of 46 PageID
`#: 18903
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`EXHIBIT 9
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`Case 1:18-cv-00924-CFC-SRF Document 261 Filed 06/21/19 Page 27 of 46 PageID
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`Case 1:18-cv-00924-CFC-SRF Document 261 Filed 06/21/19 Page 28 of 46 PageID
`#: 18905
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`EXHIBIT 10
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`Case 1:18-cv-00924-CFC-SRF Document 261 Filed 06/21/19 Page 29 of 46 PageID
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`Case 1:18-cv-00924-CFC-SRF Document 261 Filed 06/21/19 Page 30 of 46 PageID
`#: 18907
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`EXHIBIT 11
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`Case 1:18-cv-00924-CFC-SRF Document 261 Filed 06/21/19 Page 31 of 46 PageID
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`Case 1:18-cv-00924-CFC-SRF Document 261 Filed 06/21/19 Page 32 of 46 PageID
`#: 18909
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`EXHIBIT 12
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`Case 1:18-cv-00924-CFC-SRF Document 261 Filed 06/21/19 Page 33 of 46 PageID
`#: 18910
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`THIS DOCUMENT HAS
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`Case 1:18-cv-00924-CFC-SRF Document 261 Filed 06/21/19 Page 34 of 46 PageID
`#: 18911
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`EXHIBIT 13
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`Case 1:18-cv-00924-CFC-SRF Document 261 Filed 06/21/19 Page 35 of 46 PageID
`#: 18912
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`THIS DOCUMENT HAS
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`BEEN REDACTED IN ITS
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`ENTIRETY
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`Case 1:18-cv-00924-CFC-SRF Document 261 Filed 06/21/19 Page 36 of 46 PageID
`#: 18913
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`EXHIBIT 14
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`Case 1:18-cv-00924-CFC-SRF Document 261 Filed 06/21/19 Page 37 of 46 PageID
`#: 18914
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`THIS DOCUMENT HAS
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`BEEN REDACTED IN ITS
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`ENTIRETY
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`Case 1:18-cv-00924-CFC-SRF Document 261 Filed 06/21/19 Page 38 of 46 PageID
`#: 18915
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`EXHIBIT 15
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`Case 1:18-cv-00924-CFC-SRF Document 261 Filed 06/21/19 Page 39 of 46 PageID
`#: 18916
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`THIS DOCUMENT HAS
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`BEEN REDACTED IN ITS
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`ENTIRETY
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`Case 1:18-cv-00924-CFC-SRF Document 261 Filed 06/21/19 Page 40 of 46 PageID
`#: 18917
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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.
`
`
`
`
`
`
` Case No. 18-924-CFC
`
`
`
`[PROPOSED] ORDER GRANTING PLAINTIFFS’ MOTION TO COMPEL
`
`Upon consideration of Plaintiffs Genentech, Inc. and City of Hope’s Motion to Compel
`
`Amgen to Produce Documents and Witnesses,
`
`IT IS HEREBY ORDERED that Defendant Amgen, Inc.’s production of its opinion
`
`letters concerning (i) infringement and/or validity of U.S. Patent No. 8,574,869 (“the ’869
`
`patent”); and (ii) validity of U.S. Patent Nos. 6,627,196 (“the ’196 patent”), 7,371,379 (“the ’379
`
`patent”), and/or 10,160,811 (“the ’811 patent”) (collectively, “the Opinion Letters”) has effected
`
`a subject matter waiver of Amgen’s attorney-client privilege concerning (i) infringement and
`
`validity of the ’869 patent; and (ii) validity of the ’196, ’379, and ’811 patents. The waiver
`
`extends to communications pre-dating the Opinion Letters and extends to Amgen’s in-house
`
`counsel. To the extent that Amgen’s trial counsel communicated, directly or indirectly,
`
`concerning (i) infringement or validity of the ’869 patent; or (ii) validity of the ’196, ’379, or
`
`’811 patents with Laura Brand or other Amgen employees involved in Amgen’s decisions
`
`whether to make, use, sell, offer to sell, or import Kanjinti, ABP 980, or trastuzumab, the waiver
`
`also extends to such communications.
`
`ME1 30663691v.1
`
`1
`
`

`

`Case 1:18-cv-00924-CFC-SRF Document 261 Filed 06/21/19 Page 41 of 46 PageID
`#: 18918
`
`
`
`Accordingly, Amgen shall produce within seven days:
`
`1.
`
`All documents relating to assessments of (i) infringement or validity of the ’869
`
`patent; or (ii) validity of the ’196, ’379, or ’811 patents;
`
`2.
`
`All documents relating to amendments to Amgen’s proposed label for Kanjinti
`
`based upon assessments of the validity of the ’196, ’379, or ’811 patents or the outcome of inter
`
`partes review proceedings involving those patents;
`
`3.
`
`All documents relating to any experimentation, testing, or analysis to alter
`
`Amgen’s manufacturing processes to avoid Genentech’s allegations of infringement of the ’869
`
`patent;
`
`4.
`
`All documents relating to communications with and among Amgen’s in-house
`
`counsel concerning the Opinion Letters or any other assessments of (i) infringement or validity
`
`of the ’869 patent; or (ii) validity of the ’196, ’379, or ’811 patents; and
`
`5.
`
`All documents relating to communications with outside trial counsel concerning
`
`the Opinion Letters or any other assessments of (i) infringement or validity of the ’869 patent; or
`
`(ii) validity of the ’196, ’379, or ’811 patents, to the extent that such advice was provided
`
`directly or indirectly to Amgen’s business decisionmakers.
`
`IT IS FURTHER ORDERED that Amgen shall:
`
`6.
`
`Make available for deposition any in-house counsel involved in (i) obtaining the
`
`Opinion Letters; or (ii) providing advice with respect to (a) infringement or validity of the ’869
`
`patent or (b) the validity of ’196, ’379 or ’811 patents to any business decisionmakers at Amgen;
`
`and
`
`7.
`
`Make available for deposition any witnesses who were previously instructed not
`
`to answer questions at their depositions in this case relating to the subjects of paragraph 1-3
`
`ME1 30663691v.1
`
`2
`
`

`

`Case 1:18-cv-00924-CFC-SRF Document 261 Filed 06/21/19 Page 42 of 46 PageID
`#: 18919
`
`
`
`above on the basis of privilege, including: (1) Jennifer Khiem; (2) Shane Hall; (3) Benjamin
`
`Dionne; (4) Purvi Lad; and (5) Amy Nehring. These depositions shall be limited to no more than
`
`three hours on the record. Amgen shall pay Genentech’s costs and attorneys’ fees in connection
`
`with such depositions.
`
`As the parties previously agreed before the discovery hearing, Amgen shall produce (i)
`
`all communications with opinion counsel related to (a) non-infringement and/or invalidity of the
`
`’869 patent; and (b) the invalidity of the ’196, ’379, and ’811 patents; (ii) any files from opinion
`
`counsel shared with Amgen; (iii) all underlying documents and drafts of the Opinion Letters
`
`shared with Amgen; (iv) all communications regarding the opinion letters exchanged between
`
`Amgen in-house counsel and outside opinion counsel and/or any Amgen decisions makers who
`
`relied upon the opinions; and (v) any other opinion letters obtained by Amgen related to (a) non-
`
`infringement and/or invalidity of the ’869 patent; and (b) the invalidity of the ’196, ’379, and
`
`’811 patents. The Court hereby ORDERS that this production be completed within seven days.
`
`SO ORDERED this __ day of __________, 2019.
`
`
`
`
`
`
`
`
`
`
`
`
`The Honorable Colm F. Connolly
`United States District Judge
`
`
`
`
`
`ME1 30663691v.1
`
`3
`
`

`

`Case 1:18-cv-00924-CFC-SRF Document 261 Filed 06/21/19 Page 43 of 46 PageID
`#: 18920
`
`
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`
`
`
`GENENTECH, INC. and CITY OF HOPE,
`
`v.
`
`AMGEN INC.,
`
`Plaintiffs,
`
`Defendant.
`
`
`
`
`
`
` Case No. 18-924-CFC
`
`
`AVERMENT OF COUNSEL
`
`The undersigned counsel hereby certifies that counsel for Plaintiffs conferred with
`
`
`
`
`
`
`
`counsel for Defendant, including verbally in a teleconference involving Delaware counsel for all
`
`parties, regarding the relief sought in the foregoing letter and that counsel were unable to reach
`
`agreement on the relief sought.
`
`Dated: June 13, 2019
`
`Of Counsel:
`
`William F. Lee
`Lisa J. Pirozzolo
`Emily R. Whelan
`Kevin S. Prussia
`Andrew J. Danford
`Stephanie Neely
`WILMER CUTLER PICKERING
` HALE AND DORR LLP
`60 State Street
`Boston, MA 02109
`
`Robert J. Gunther, Jr.
`WILMER CUTLER PICKERING
`HALE AND DORR LLP
`7 World Trade Center
`250 Greenwich Street
`New York, NY 10007
`
`
`M E 1 3 0 6 6 0 8 8 3 v . 1
`
`
`MCCARTER & ENGLISH, LLP
`
`/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
`
`Counsel for Plaintiffs Genentech, Inc.,
`and City of Hope
`
`

`

`Case 1:18-cv-00924-CFC-SRF Document 261 Filed 06/21/19 Page 44 of 46 PageID
`#: 18921
`
`
`
`
`Nora Passamaneck
`WILMER CUTLER PICKERING
`HALE AND DORR LLP
`1225 17th Street, Suite 2600
`Denver, CO 80202
`
`Nancy Schroeder
`WILMER CUTLER PICKERING
`HALE AND DORR LLP
`350 S Grand Avenue, Suite 2100
`Los Angeles, CA 90071
`
`Darlyn Durie
`Adam Brausa
`DURIE TANGRI LLP
`217 Leidesdorff Street
`San Francisco, CA 94111
`
`David I. Berl
`Thomas S. Fletcher
`Charles L. McCloud
`Teagan J. Gregory
`WILLIAMS & CONNOLLY LLP
`725 Twelfth St. NW
`Washington, DC 20005
`
`
`
`M E 1 3 0 6 6 0 8 8 3 v . 1
`
`2
`
`

`

`Case 1:18-cv-00924-CFC-SRF Document 261 Filed 06/21/19 Page 45 of 46 PageID
`#: 18922
`
`
`
`CERTIFICATE OF SERVICE
`
`The undersigned counsel hereby certifies that true and correct copies of the foregoing
`
`
`
`document were caused to be served on June 13, 2019 on the following counsel in the manner
`
`indicated:
`
`VIA EMAIL:
`
`Neal C. Belgam
`Eve H. Ormerod
`SMITH, KATZENSTEIN & JENKINS, LLP
`1000 West Street, Suite 1501
`Wilmington, DE 19801
`(302) 652-8400
`nbelgam@skjlaw.com
`eormerod@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
`
`Michelle Rhyu
`Susan Krumplitsch
`Daniel Knauss
`COOLEY, LLP
`3175 Hanover Street
`Palo Alto, CA 94304-1130
`P 650-843-5287
`rhyums@cooley.com
`skrumplitsch@cooley.com
`dknauss@cooley.com
`
`
`
`
`
`ME1 30660882v.1
`
`

`

`Case 1:18-cv-00924-CFC-SRF Document 261 Filed 06/21/19 Page 46 of 46 PageID
`#: 18923
`
`
`
`
`Nancy Gettel
`Thomas Lavery, IV
`AMGEN, INC.
`One Amgen Center Drive
`Thousand Oaks, CA 91320-1799
`P 805-447-1000
`ngettel@amgen.com
`tlavery@amgen.com
`
`Attorneys for Defendant Amgen Inc.
`
`
`
`Dated: June 13, 2019
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`/s/ Daniel M. Silver
`Daniel M. Silver (#4758)
`
`
`
`
`
`
`ME1 30660882v.1
`
`2
`
`

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