Case 1:18-cv-00924-CFC-SRF Document 213 Filed 05/20/19 Page 1 of 70 PageID #:
`17989
`
`
`
`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
`
`
`
`
`
`
`
`
`
`
`
`PLAINTIFFS’ LETTER BRIEF IN SUPPORT OF ITS MOTION TO COMPEL AMGEN
`TO PRODUCE DOCUMENTS AND WITNESSES
`
`
`
`Michael P. Kelly (#2295)
`Daniel M. Silver (#4758)
`Alexandra M. Joyce (#6423)
`MCCARTER & ENGLISH, LLP
`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
`
`Dated: May 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
`
`
`
`M E1 3 0 4 1 6 18 4 v. 1
`
`PUBLIC VERSION FILED
`MAY 20, 2019
`
`

`

`Case 1:18-cv-00924-CFC-SRF Document 213 Filed 05/20/19 Page 2 of 70 PageID #:
`17990
`
`
`
`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
`
`
`
`
`M E1 3 0 4 1 6 18 4 v. 1
`
`
`
`

`

`Case 1:18-cv-00924-CFC-SRF Document 213 Filed 05/20/19 Page 3 of 70 PageID #:
`17991
`
`
`
`Dear Judge Connolly:
`
`I write on behalf of Plaintiffs to request that the Court compel Defendant Amgen, Inc. to:
`produce by May 23 all outstanding documents, including certain relevant documents described
`further below; and make available for further deposition certain witnesses for whom Amgen has
`failed to timely produce documents.
`
`By way of background, this is a patent infringement action related to Amgen’s Kanjinti product,
`which is a proposed biosimilar to Genentech’s Herceptin.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Also giving rise to the instant dispute is Amgen’s failure to timely produce documents. The
`deadline for the parties to complete substantial production of documents was January 14, 2019.
`D.I. 43 at 3. Amgen failed to meet this deadline. (Ex.1 at 3) As of today, Amgen has produced
`just 10,000 documents total from its custodians and has made clear that substantial portions of its
`documents have yet to be produced.1 By comparison, Plaintiffs have produced over 255,000
`documents from its custodians—the vast majority of which was produced when it should have
`been in January. Amgen’s failure to comply with the Court’s scheduling order has caused
`significant prejudice to Genentech and threatens the December trial date in this case. As just one
`example, Plaintiffs highlight the deposition of Amgen’s corporate designee
`, which
`was scheduled for May 10.
` was designated under the Stipulated ESI Order as one
`of the ten Amgen custodians most likely to have potentially responsive information. Yet, as of
`four days before his deposition, Amgen had produced a grand total of twenty-one documents
`from his files. (Ex.1 at 33) The next day, Amgen reported (for the first time) that
`notwithstanding the four-month-expired deadline for document production, it was still
`“processing”
` documents for production. Amgen ultimately unilaterally vacated
`the May 10
` deposition, (Ex.2 at 1,2), promising the forthcoming production of
`
` documents. As further explained below, this is not a one-time situation.
`
`Plaintiffs have tried to work with Amgen on these issues, but require Court assistance to finally
`resolve them. A Proposed Order (“PO”) is submitted herewith. There also remain outstanding
`issues which Plaintiffs have not included herein based on representations by Amgen that the
`discovery will be provided. (Ex.3 at 1) Plaintiffs request that the Court order that all
`outstanding productions be completed by May 23, 2019. (PO at ¶ 5) The specific disputes as to
`which Plaintiffs request relief now are as follows:
`
`
`1 Over 3,000 of these documents were produced between midnight Thursday night and today.
`
`
`
`1
`
`

`

`Case 1:18-cv-00924-CFC-SRF Document 213 Filed 05/20/19 Page 4 of 70 PageID #:
`17992
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`
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`Documents sufficient to show the pricing and contracting of Kanjinti: Documents
`1.
`reflecting Amgen’s pricing strategy for Kanjinti, as well as documents identifying the contracts
`Amgen has entered into regarding the sale and distribution of Kanjinti are relevant to remedies
`and infringement. To the extent that such contracts exist, they may reflect infringing “offers for
`sale.” And Amgen’s pricing strategy will inform the remedies that Plaintiffs may seek should
`Amgen launch its product in violation of Plaintiffs’ patent rights. Plaintiffs have produced such
`documents in response to Amgen’s requests. (Ex.4) Amgen has produced some documents as
`well, but not all such documents, and,
`
`requested information. (PO at ¶ 1.)
`
`2.
`
`. The Court should order Amgen to produce the
`
`
`
`
`
`
`
`
`
`
`
`
`Documents related to the marketing and/or use of Kanjinti (proposed, planned, or
`3.
`actual): Documents reflecting Amgen’s intended use of Kanjinti are relevant to induced
`infringement. Amgen’s position is that only “approved” and “distributed” “marketing”
`documents are probative of inducement and that yet-to-be approved documents and internal
`communications are not. That is not correct. 35 U.S.C. § 271(e)(2)(C) provides a cause of
`action for patent infringement based upon how a product will be used upon FDA approval.
`Amgen may not avoid discovery concerning how it intends its product to be used upon FDA
`approval; Congress provided a statutory basis for addressing patent infringement prospectively
`before a biosimilar product is approved by the FDA.
`
`
`
`
`
`
`
`
`
` Yet under Amgen’s narrow approach to discovery, Amgen
`has excluded these documents from its production.
`
`The parties have agreed-upon search terms that Plaintiffs believe will hit on the information
`sought by this topic when run against the ESI of Amgen’s marketing custodians. Plaintiffs seek
`an order directing Amgen to produce all non-privileged documents hitting on such search terms
`from its marketing custodians regardless of whether Amgen views the document as not reflecting
`“approved” or “distributed” “marketing” materials. (PO at ¶ 3.)
`
`
`
`
`2
`
`

`

`Case 1:18-cv-00924-CFC-SRF Document 213 Filed 05/20/19 Page 5 of 70 PageID #:
`17993
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`
`
`4.
`
`Updated custodial ESI regarding the changes reflected in Amgen’s
`
`
`: Amgen
`should be required to produce custodial ESI from
` created since its prior collection
`
`of her files in August 2018.
` She was disclosed by Amgen as one of its ten custodians most likely to
`have discoverable information. Yet as of Thursday night Amgen had produced only seven
`documents from her files to date. Since then, Amgen has produced an additional 894 documents.
`
` is expected to have
`As
`
`relevant information regarding the reasons for Amgen’s
`. Plaintiffs ask that Amgen be required to update its document production for
`, using the parties’ agreed upon search terms, so that Plaintiffs may obtain discovery
`Ms.
`concerning these recent developments. (PO at ¶ 4.)
`
`An Order directing Amgen to complete all production of documents by May 23 and
`5.
`re-produce, at Amgen’s cost, any witnesses for deposition for whom documents were not
`timely produced: Amgen has made clear that it continues to produce substantial volumes of
`custodial documents even though the deadline for such production was in January. The reason
`for the document production deadline was to give the parties sufficient time to review documents
`in advance of depositions. Plaintiffs complied with the scheduling order; Amgen has not. Since
`December, Plaintiffs have been trying to work with Amgen to address its late production—to no
`avail. (Ex.1, passim) The result has been a chaotic deposition discovery period where, in some
`instances, Amgen has unilaterally pulled depositions off the calendar on the eve of the deposition
`(Ex. 2 at 2,3); and, in others, has forced Plaintiffs to move forward with depositions despite not
`having possession of all of the witness’s documents (Ex.5 at 4). To make matters worse, in an
`effort to accommodate Amgen’s severely late productions, Plaintiffs recently agreed to extend
`the dates in the scheduling order on the condition that Amgen agree to complete its production
`by May 13. (Ex.3 at 1). Amgen initially agreed, (Ex.6 at 2), only to renege at the eleventh
`hour—claiming first that it was having technical issues with the documents of a single custodian,
`and then later explaining that it was facing issues generally with its production. (Ex.7 at 1).
`While one-off productions during the deposition period are to be expected (indeed, Plaintiffs
`have had to make such productions on a few occasions), what is clear is that this is not a “one-
`off” situation when it comes to Amgen’s documents. Amgen is one of the world’s largest
`biotech companies and has been working on developing a biosimilar to trastuzumab for well over
`six years. Yet, as of Thursday, Amgen had produced a total of about 8,600 custodial documents,
`including just twenty-seven documents total from its two custodians who have been identified as
`key marketing custodians. That is simply not credible. Amgen refuses to disclose how many
`documents it has yet to produce, but Plaintiffs fear that the number is substantial. Plaintiffs
`should not have to be prejudiced by Amgen’s dilatory conduct.
`
`Accordingly, Plaintiffs respectfully request an order requiring Amgen to make available for a
`continued deposition, at Amgen’s cost, any witness for whom relevant documents were not
`available at least four business days in advance of the initial deposition. Plaintiffs should have
`the flexibility to take such continued depositions outside the period for fact discovery and the
`ability to supplement its opening expert reports with any information arising out of those
`continued depositions. (PO at ¶ 5.)
`
`
`
`3
`
`

`

`Case 1:18-cv-00924-CFC-SRF Document 213 Filed 05/20/19 Page 6 of 70 PageID #:
`17994
`
`
`
`
`MCCARTER & ENGLISH, LLP
`
`/s/ Michael P. Kelly
`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
`
`
`Dated: May 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
`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
`
`
`
`
`
`4
`
`

`

`Case 1:18-cv-00924-CFC-SRF Document 213 Filed 05/20/19 Page 7 of 70 PageID #:
`17995
`
`EXHIBIT 1
`
`

`

`Case 1:18-cv-00924-CFC-SRF Document 213 Filed 05/20/19 Page 8 of 70 PageID #:
`17996
`
`December 19, 2018
`
`By E-Mail
`
`Michelle Rhyu
`Susan Krumplitsch
`Daniel J. Knauss
`Orion Armon
`Eamonn Gardner
`COOLEY LLP
`
`Nora Q.E. Passamaneck
`
`+1 720 274 3152 (t)
`+1 720 274 3133 (f)
`nora.passamaneck@wilmerhale.com
`
`Re: Genentech, Inc. et al. v. Amgen, Inc., Case No. 18-924-CFC (D. Del.): Amgen’s
`Responses to Plaintiffs’ Document Requests
`
`Counsel,
`
`I write to address Amgen’s December 11, 2018 letter regarding the parties’ responses to
`document requests, and the deficiencies in Amgen’s document productions to date. Amgen has
`not produced documents responsive to the majority of Genentech’s RFPs, and its RFP responses
`remain wholly inadequate. In the meantime, Genentech has produced over 71,000 documents
`(over 950,000 pages) going back 20 years, including lab notebooks, regulatory documents,
`marketing and sales documents, and relevant ESI. The deadline for close of substantial
`document production in this case is January 14, 2018, less than one month from today, and the
`purpose of this deadline is to ensure that the parties have sufficient time before depositions and
`the close of fact discovery to review. Plaintiffs have taken the necessary steps to meet this
`deadline; Plaintiffs expect Amgen to do the same.
`
`In Amgen’s December 11 letter, Amgen continues to insist that Genentech’s requests are not
`relevant, asserting that Genentech’s requests are only relevant if Genentech can describe with
`particularity the nexus between the asserted patents and the hypothetical responsive documents is
`overly restrictive and improper. (See, e.g., Plaintiffs’ Request No. 10.) Genentech has
`repeatedly explained the relevance of its requests, both in writing and during our meet and
`confers. Amgen’s decision to market a biosimilar to Herceptin is the act of infringement that
`forms the basis of this lawsuit, and Genentech is entitled to discovery on Amgen’s business
`decisions, launch plans, and the steps (including analysis of Herceptin) taken in pursuit of this
`act of infringement. Genentech further notes that Amgen has served extremely broad requests
`(e.g., documents concerning “any Her2-positive breast cancer treatment”), yet disputes the
`relevance of Genentech’s requests with a reciprocal scope (e.g., documents concerning “HER2
`products”). (See, e.g., Plaintiffs’ Request No. 12). If Amgen refuses to produce documents
`responsive these requests, Plaintiffs will seek relief from the Court.
`
`Second, Amgen has stated in response to several requests that it will “reexamine the relevance”
`of Genentech’s requests and/or “review its response and follow up if needed.” (See, e.g.,
`Plaintiffs’ Request No. 10, 12, 17, 23, 21, 22, 25, 27, 32, 34, 37, 40, 41, 44, 45, 46, 52, 53).
`These responses are insufficient, especially at this late date. Amgen has not stated, in accordance
`with the Federal Rules of Civil Procedure, whether it is withholding documents or its basis for
`withholding documents. Nor, apparently, has Amgen even attempted to investigate what, if any,
`
`Ex. 1_001
`
`

`

`Case 1:18-cv-00924-CFC-SRF Document 213 Filed 05/20/19 Page 9 of 70 PageID #:
`17997
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`
`
`responsive documents exist. To be clear, Plaintiffs raised this issue in their November 12, 2018
`letter, asked for substantive responses during the parties’ November 30, 2018 meet-and-confer,
`and now, a month later, Amgen still has not provided any real information on these requests. As
`Plaintiffs explained at the November 30, 2018 meet-and-confer, Amgen has an obligation under
`FRCP 34(b)(2)(C) to state, as to each request, whether it is withholding responsive documents so
`that Genentech can decide whether to move to compel. If Amgen intends to produce responsive
`documents to these requests, please state the date on which it will begin to produce documents,
`in accordance with FRCP 34(b)(2)(B). See 2015 Committee Notes on Rules – 2015 Amendment
`(“When it is necessary to make the production in stages the response should specify the
`beginning and end dates of the production.”).
`
`Please provide a response to the issues raised in this letter by December 21. If Amgen refuses to
`produce documents and we have reached impasse, please also provide your availability for a
`meet and confer with local counsel present.
`
`Kind regards,
`
`/s/ Nora Q.E. Passamaneck
`
`Nora Q.E. Passamaneck
`
`
`
`
`
`ActiveUS 170740105v.1
`
`Ex. 1_002
`
`

`

`Case 1:18-cv-00924-CFC-SRF Document 213 Filed 05/20/19 Page 10 of 70 PageID
`#: 17998
`
`Lin, Stephanie
`From:
`Sent:
`To:
`
`Cc:
`Subject:
`
`Lin, Stephanie
`Wednesday, January 16, 2019 10:54 AM
`Krickl, Lauren; WH GNE-Amgen Herceptin Service List; Passamaneck, Nora Q.E.; Neely, Stephanie;
`Danford, Andrew J; DDurie@durietangri.com; abrausa@durietangri.com; EWiener@durietangri.com;
`mkelly@mccarter.com; dsilver@mccarter.com
`z/Amgen-Genentech; Neal C. Belgam; Eve H. Ormerod
`RE: Genentech, Inc. et al. v. Amgen, Inc. (18-924-CFC): Document Production
`
`Hi Lauren, 
` 
`We received Amgen’s letter yesterday stating that you are producing about 30K pages via secure file transfer, but we 
`have yet to actually receive the documents.  Can you please re‐send the link? 
` 
`In addition, can you confirm that with this production, Amgen believes its production is substantially complete? 
` 
`Best, 
`Stephanie 
` 
`Stephanie Lin | WilmerHale 
`60 State Street 
`Boston, MA 02109 USA 
`+1 617 526 6789 (t) 
`+1 617 526 5000 (f) 
`stephanie.lin@wilmerhale.com 
` 
`Please consider the environment before printing this email. 
`
`This email message and any attachments are being sent by Wilmer Cutler Pickering Hale and Dorr LLP, are confidential, and may be privileged. If you are not 
`the intended recipient, please notify us immediately—by replying to this message or by sending an email to postmaster@wilmerhale.com—and destroy all 
`copies of this message and any attachments. Thank you. 
` 
`For more information about WilmerHale, please visit us at http://www.wilmerhale.com.  
`From: Krickl, Lauren <lkrickl@cooley.com>  
`Sent: Tuesday, January 15, 2019 2:57 AM 
`To: WH GNE‐Amgen Herceptin Service List <WHGNE‐AmgenHerceptinServiceList@wilmerhale.com>; Passamaneck, Nora 
`Q.E. <Nora.Passamaneck@wilmerhale.com>; Neely, Stephanie <Stephanie.Neely@wilmerhale.com>; Lin, Stephanie 
`<Stephanie.Lin@wilmerhale.com>; Danford, Andrew J <Andrew.Danford@wilmerhale.com>; DDurie@durietangri.com; 
`abrausa@durietangri.com; EWiener@durietangri.com; mkelly@mccarter.com; dsilver@mccarter.com 
`Cc: z/Amgen‐Genentech <zAmgenGenentech@cooley.com>; Neal C. Belgam <NCB@skjlaw.com>; Eve H. Ormerod 
`<eho@skjlaw.com> 
`Subject: Genentech, Inc. et al. v. Amgen, Inc. (18‐924‐CFC): Document Production 
` 
`Counsel,
` 
`We are in the process of finalizing our document production, but will likely be unable to complete our production 
`tonight.  We will endeavor to send the production to you as soon as we are able, likely tomorrow. 
` 
`Thank you, 
`Lauren 
`
`1
`
`Ex. 1_003
`
`

`

`Case 1:18-cv-00924-CFC-SRF Document 213 Filed 05/20/19 Page 11 of 70 PageID
`#: 17999
`
` 
`Lauren Krickl
`Cooley LLP
`3175 Hanover Street
`Palo Alto, CA 94304-1130
`Direct: +1 650 843 5065 • Fax: +1 650 849 7400
`Email: lkrickl@cooley.com • www.cooley.com
` 
` 
`
`
`This email message is for the sole use of the intended recipient(s) and may contain confidential and privileged information. Any unauthorized review, use,
`disclosure or distribution is prohibited. If you are not the intended recipient, please contact the sender by reply email and destroy all copies of the original message.
`If you are the intended recipient, please be advised that the content of this message is subject to access, review and disclosure by the sender's Email System
`Administrator. 
`
`2
`
`Ex. 1_004
`
`

`

`
`
`Case 1:18-cv-00924-CFC-SRF Document 213 Filed 05/20/19 Page 12 of 70 PageID
`#: 18000
`
`
`
`January 18, 2019
`
`By E-mail
`
`Lauren Krickl
`Michelle Rhyu
`Daniel J. Knauss
`Orion Armon
`Eamonn Gardner
`Benjamin Lin
`COOLEY LLP
`
`Stephanie Lin
`
`+1 617 526 6789 (t)
`+1 617 526 5000 (f)
`stephanie.lin@wilmerhale.com
`
`Re: Genentech, Inc et al. v. Amgen, Inc. (18-924-CFC): Amgen Document Production
`
`Lauren,
`
`As you know, the deadline for substantial completion of document production was January 14,
`2019. See D.I. 44. Amgen did not meet that deadline. Prior to January 14, Amgen produced
`only 4,270 documents, the majority of which appears to be regulatory documents. On
`January 16, 2019, two days after the date for substantial completion, Amgen made its first
`production of custodial ESI. We were surprised to see that this production includes fewer than
`2,400 documents, and notably, you did not answer the question in my January 16 email as to
`whether Amgen believes that it has substantially completed its production. By January 22, 2019,
`please answer whether Amgen believes that it has substantially completed its production.
`
`Sincerely,
`
`/s/ Stephanie Lin
`
`
`
`
`
`
`
`
`
`
`
`
`Ex. 1_005
`
`

`

`Case 1:18-cv-00924-CFC-SRF Document 213 Filed 05/20/19 Page 13 of 70 PageID
`#: 18001
`
`
`
`
`
`Nora Q.E. Passamaneck
`
`+1 720 274 3152 (t)
`+1 720 274 3133 (f)
`nora.passamaneck@wilmerhale.com
`
`January 23, 2019
`
`By E-Mail
`
`Michelle Rhyu
`Susan Krumplitsch
`Daniel J. Knauss
`Orion Armon
`Eamonn Gardner
`COOLEY LLP
`
`Re: Genentech, Inc. et al. v. Amgen, Inc., Case No. 18-924-CFC (D. Del.): Amgen’s FDA
`Correspondence and Document Production
`
`Counsel,
`
`It does not appear that Amgen produced any documents regarding the
`
` These
`documents are not only responsive to Plaintiffs’ discovery requests (see, e.g., RFP Nos. 1, 2, 4,
`and 5) and directly relevant to the issues in this case, but were also expressly requested in my
`December 21, 2018 letter. Please produce these materials immediately—along with any other
`documents that Amgen has failed to produce relating to its submissions and communications
`with the FDA. As you know, the substantial completion date was over a week ago and the
`parties are in the midst of claim construction. Documents regarding the accused products are
`highly relevant to the issues in this case and Amgen’s belated productions and continuing failure
`to produce documents relating to its regulatory submissions is improper and prejudicial.
`
`
`
`Relatedly, we have not received a response from Amgen in response to our inquiries on January
`16, and 18, 2019 regarding the status of Amgen’s document production. The substantial
`completion date was on January 14, 2019, yet Amgen has produced fewer than 2,400 custodial
`documents. Accordingly, please let us know the status of Amgen’s production.
`
`We expect that Amgen will be prepared to discuss these issues on the upcoming call tentatively
`scheduled for January 28, 2019 at 12 EST.
`
` Kind regards,
`
`/s/ Nora Q.E. Passamaneck
`
`Nora Q.E. Passamaneck
`
`
`
`
`
`Ex. 1_006
`
`

`

`Case 1:18-cv-00924-CFC-SRF Document 213 Filed 05/20/19 Page 14 of 70 PageID
`#: 18002
`
`
`
`
`
`Nora Q.E. Passamaneck
`
`+1 720 274 3152 (t)
`+1 720 274 3133 (f)
`nora.passamaneck@wilmerhale.com
`
`January 28, 2019
`
`By E-Mail
`
`Michelle Rhyu
`Susan Krumplitsch
`Daniel J. Knauss
`Orion Armon
`Eamonn Gardner
`COOLEY LLP
`
`Re: Genentech, Inc. et al. v. Amgen, Inc., Case No. 18-924-CFC (D. Del.): Amgen’s FDA
`Correspondence and Document Production
`
`Counsel,
`
`Amgen’s January 25, 2019 letter raises more questions than answers. During the parties’ meet-
`and-confer, please be prepared to answer the following:
`
`1.
`
`
`
`, and Plaintiffs
`have made repeated requests for these documents. Amgen has no basis to withhold these
`documents, especially where any changes to Amgen’s manufacturing process may impact
`the infringement analysis. During the meet-and-confer, Plaintiffs expect Amgen to
`identify whether any documents exist, and explain the basis for why they have yet to be
`produced.
`
`2. Does Amgen believe that it has substantially completed its document production?
`You state in your August 25, 2019 letter that “Amgen has made substantial productions
`of documents comprising over 2.7 million pages,” but this statement does not answer the
`question posed in our January 16, 18, and 23 correspondences asking Amgen to
`affirmatively state whether it has substantially completed its document production.
`
`3. You state in your August 25, 2019 letter that “Amgen is currently reviewing certain
`regulatory documents and some additional custodial documents.” How many
`additional custodial documents is Amgen still reviewing? Amgen has produced fewer
`than 2,400 custodial documents, and it seems unlikely that Amgen’s search terms –
`including terms such as “Herceptin,” “trastuzumab,” “ABP980,” and “Kanjinti” – would
`return only 2,400 responsive, non-privileged documents. Indeed, in comparison,
`Plaintiffs have produced over 190,000 responsive, non-privileged documents from its
`custodians, and Plaintiffs’ search terms for Amgen to run these same Amgen custodians
`return over 20,000 documents to review. Amgen’s production of custodial ESI on its
`face is deficient, and if Amgen asserts that its production of custodial ESI identified
`through its own search terms is complete then Plaintiffs request that Amgen provide its
`hit report for each search term that Amgen included in its November 27, 2018 disclosure.
`
`
`
`Ex. 1_007
`
`

`

`Case 1:18-cv-00924-CFC-SRF Document 213 Filed 05/20/19 Page 15 of 70 PageID
`#: 18003
`
`
`
`Given that the deadline for substantial completion of document production was two weeks ago,
`please ensure that Amgen’s Delaware counsel will participate in our meet-and-confer tomorrow.
`
`Regards,
`
`/s/ Nora Q.E. Passamaneck
`
`Nora Q.E. Passamaneck
`
`
`
`
`
`
`Ex. 1_008
`
`

`

`Case 1:18-cv-00924-CFC-SRF Document 213 Filed 05/20/19 Page 16 of 70 PageID
`#: 18004
`
`
`
`Nora Q.E. Passamaneck
`
`+1 720 274 3152 (t)
`+1 720 274 3133 (f)
`nora.passamaneck@wilmerhale.com
`
`
`
`CONTAINS CONFIDENTIAL INFORMATION
`PURSUANT TO PROTECTIVE ORDER
`
`January 30, 2019
`
`By E-Mail
`
`Michelle Rhyu
`Susan Krumplitsch
`Daniel J. Knauss
`Orion Armon
`Eamonn Gardner
`COOLEY LLP
`
`Re: Genentech, Inc. et al. v. Amgen, Inc., Case No. 18-924-CFC (D. Del.): Amgen’s
`Deficient Document Production
`
`Counsel,
`
`We write regarding ongoing deficiencies in Amgen’s document production. These issues have
`been pending for several weeks and the parties conferred about them yesterday. They raise
`questions not only about the adequacy of Amgen’s document production, but the nature of
`Amgen’s collection and production efforts. We write to see if the parties can resolve these issues
`without court involvement.
`
`First, it is now abundantly clear that Amgen is withholding highly relevant documents regarding
`the accused product. For two months, Plaintiffs have repeatedly requested Amgen’s production
`of its submissions and correspondence with the FDA regarding Kanjinti. For example:
`
`• December 6, 2018 letter: “Has Amgen submitted a resubmission and/or had additional
`communications with the FDA regarding ABP 980? These communications are relevant
`to the issues of infringement and damages, and are responsive to Plaintiffs’ discovery
`requests. (See Pls.’ RFP Nos. 1-4.) By December 10, 2018, please confirm that Amgen
`will supplement its production with any recent communications with the FDA and produce
`them no later than December 13, 2018.”
`
`• December 14, 2018 letter: “On December 14, 2018, Amgen responded that it ‘will
`supplement its production of submissions to the FDA regarding ABP 980 on a rolling basis
`and in accordance with the applicable discovery deadlines in this case.’ Amgen’s response
`does not answer Plaintiffs’ December 6 letter.
`
`? If so, Amgen
`should produce that correspondence immediately. Any changes to ABP 980 and its
`potential approval will directly affect the issues in this case and the scope of discovery.”
`
`• December 21, 2018 letter:
`
`
`
`
`
`
`
`
`
`Ex. 1_009
`
`

`

`Case 1:18-cv-00924-CFC-SRF Document 213 Filed 05/20/19 Page 17 of 70 PageID
`#: 18005
`
`.”
`
`
`
`• January 16, 2018 letter: “
`
`
`
`. See
`December 21, 2018 letter from Passamaneck. Genentech expects that Amgen will promptly
`produce documents regarding any changes to ABP 980, which may raise issues directed to
`patents currently not at issue and are responsive to several requests . . . .”
`
`• January 23, 2019 letter:
`
`
`
`
`
`
`.”
`
`• January 28, 2019 letter:
`
`
`
`
`. During
`the meet-and-confer, Plaintiffs expect Amgen to identify whether any documents exist, and
`explain the basis for why they have yet to be produced.”
`
`Amgen’s responses to these multiple requests have been to assure Plaintiffs that it was complying
`with its discovery obligations and has been producing documents as they became available.
`Accordingly, we were surprised to learn from the news (not Amgen) that Amgen resubmitted its
`BLA
`for Kanjinti
`ago,
`in December
`2018.
`
`See
`over
`a month
`https://www.amgen.com/media/news-releases/2019/01/amgen-reports-fourth-quarter-and-full-
`year-2018-financial-results/. Plaintiffs have not received these documents and Amgen has not
`explained its delay, despite the fact that the Court’s deadline for substantial completion of
`document production was January 14, 2019 (over two weeks ago, and one month after Plaintiffs’
`first letter seeking these documents). Amgen’s delay in producing these documents is highly
`prejudicial to Plaintiffs. Among other things, Plaintiffs have been required to elect patents and
`claims to assert against a product that is different from the product that Amgen currently expects
`to market. Amgen delayed producing documents regarding those manufacturing changes—which
`it knew about at the time of the election deadline—until December 18, 2018. Now, Amgen has
`again delayed producing documents regarding its resubmission, which presumably detail further
`changes to the accused product, until after Plaintiffs submitted their opening claim construction
`brief.
`
`Amgen’s conduct is improper. By February 1, 2019, please produce all remaining FDA
`submissions and correspondence regarding Kanjinti.
`
`Second, Plaintiffs continue to have concerns regarding Amgen’s custodial ESI production. Amgen
`has identified ten custodians who are likely to possess relevant ESI. Yet Amgen has only produced
`about 2,400 documents from these ten custodians. On our meet and confer yesterday, Amgen
`represented that it has substantially completed production of its custodial ESI. To the extent that
`
`
`
`
`Ex. 1_010
`
`

`

`Case 1:18-cv-00924-CFC-SRF Document 213 Filed 05/20/19 Page 18 of 70 PageID
`#: 18006
`
`representation is correct, it raises serious questions about the nature of Amgen’s process for
`identifying responsive custodial ESI. Amgen has been working on its Kanjinti product since at
`least 2011. A custodial production of just 2,400 documents (i.e., about 240 documents per
`custodian on average) is inconsistent with that purportedly years-long development period. It
`raises questions in our mind regarding the individuals whom Amgen selected as ESI custodians,
`the nature of the dataset that was collected from those custodians, and the process that Amgen
`employed to review those datasets to identify responsive documents. For example, Amgen’s ESI
`disclosure on November 27, 2018 identified custodial search terms including “Herceptin,”
`“trastuzumab,” “ABP980,” and “Kanjinti”. It seems that such searches would yield more than just
`2,400 documents for production—especially given the several instances where Amgen has
`described Amgen’s ESI review as “burdensome.”
`
`So that Plaintiffs can assess whether Amgen has met its discovery obligations, please provide the
`following information: the total number of documents collected from each of Amgen’s ESI
`custodians, the number of “hits” for each search term for each custodian, and the overall rate of
`responsiveness of the documents reviewed for each custodian. Please provide this information by
`February 4, 2019.
`
`Kind regards,
`
`/s/ Nora Q.E. Passamaneck
`
`Nora Q.E. Passamaneck
`
`
`
`
`
`
`Ex. 1_011
`
`

`

`Case 1:18-cv-00924-CFC-SRF Document 213 Filed 05/20/19 Page 19 of 70 PageID
`#: 18007
`
`Lin, Stephanie
`From:
`Sent:
`To:
`
`Cc:
`
`Subject:
`
`Lin, Stephanie
`Friday, February 8, 2019 3:36 PM
`Krickl, Lauren; Passamaneck, Nora Q.E.; z/Amgen-Genentech; nbelgam@skjlaw.com;
`eormerod@skjlaw.com; mkelly@mccarter.com; dsilver@mccarter.com
`WH GNE-Amgen Herceptin Service List; DDurie@durietangri.com; EWiener@durietangri.com;
`abrausa@durietangri.com
`RE: Genentech, Inc. et al. v. Amgen, Inc. (18-924-CFC): correspondence
`
`Counsel,  
`
`  
`Your Feb. 1 letter states that Amgen will expand its ESI search beyond the originally named custodians and intends to