Case 2:20-cv-00337-JRG Document 206 Filed 11/08/21 Page 1 of 10 PageID #: 8325
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`IN THE UNITED STATES DISTRICT COURT
`EASTERN DISTRICT OF TEXAS
`MARSHALL DIVISION
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`SEAGEN INC.,
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`Plaintiff,
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`v.
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`DAIICHI SANKYO CO., LTD.,
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`Defendant, and
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`ASTRAZENECA PHARMACEUTICALS
`LP and ASTRAZENECA UK LTD.,
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`Intervenor-Defendants.
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`CASE NO. 2:20-cv-00337-JRG
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`DAIICHI SANKYO COMPANY, LIMITED’S OPPOSITION
`TO PLAINTIFF’S MOTION TO COMPEL PRODUCTION OF
`DEVELOPMENT DOCUMENTS AND FOR RELIEF UNDER RULE 37
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`Case 2:20-cv-00337-JRG Document 206 Filed 11/08/21 Page 2 of 10 PageID #: 8326
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`I.
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`INTRODUCTION
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`This discovery dispute first arose in the spring and was resolved by stipulation in April
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`2021. (Dkt. No. 92.) Daiichi Sankyo Japan produced the documents as promised in the stipulation,
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`and nearly six months have passed. Seagen did not renew its motion until after Daiichi Sankyo
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`Japan filed its pending motions to compel (Dkt Nos. 178-79).
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`Seagen delayed its renewed motion because it has no legitimate substantive complaint.
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`Following the April 2021 agreement, Daiichi Sankyo Japan performed an exhaustive search,
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`produced all responsive documents under a reasonable interpretation of Seagen’s revised requests,
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`and produced every requested document—despite its objections—in the spirit of compromise.
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`Despite Daiichi Sankyo Japan’s full compliance and extensive production, Seagen now claims
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`Daiichi Sankyo Japan’s production is missing categories of documents concerning ADC
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`(1) conjugation and (2) linker component selection. In support of its claim, Seagen identified, for
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`the first time, 13 documents—a determination it seemingly made based on file name alone—that
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`purportedly demonstrate Daiichi Sanko Japan has withheld documents within those two categories.
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`Even though these documents are not responsive to Seagen’s requests, Daiichi Sankyo Japan
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`quickly produced all identified documents in its possession. Yet, Seagen has refused to withdraw
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`its motion. Daiichi Sankyo Japan’s production is complete; Seagen’s motion should be denied.
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`II.
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`BACKGROUND
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`In Seagen’s April 16, 2021 motion regarding its Document Topic Nos. 2, 6-7, Seagen
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`limited its overbroad requests in response to Daiichi Sankyo Japan’s objections, enabling the
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`Parties to reach agreement on the revised requests pertaining to the development of Enhertu®:
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`Seagen Revised Document Topic No. 2: Daiichi Sankyo Japan agrees to produce non-
`privileged, non-work product documents created through December 2015 that reflect the
`research and development work for Enhertu, which includes the linker used in Enhertu.
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`Case 2:20-cv-00337-JRG Document 206 Filed 11/08/21 Page 3 of 10 PageID #: 8327
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`Daiichi Sankyo Japan also agrees to search for and produce non-privileged, non-work product
`documents created through December 2015 from Toshinori Agatsuma, Toshiaki Ohtsuka,
`Kimihisa Ichikawa, Koji Morita, Hideki Miyazaki, Yuji Suzuki, and Toshimasa Jindo that reflect
`their work, if any, relating to ADC linkers.
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`Seagen Revised Document Topic Nos. 6 and 7: Because Seagen has limited these requests to
`documents that concern the development of the linker used in Enhertu (see Seagen Revised
`Document Topic No. 2 above), Daiichi Sankyo Japan agrees to search for and produce non-
`privileged, non-work product documents that refer to Seattle Genetics, SGI, Seagen, or any other
`name used within Daiichi Sankyo Japan to refer to Seagen or any of Seagen’s ADC research and
`development work, including documents that refer to information obtained from Seagen (Topic
`No. 6) or the named inventors of the patent-in-suit (Topic No. 7) to the extent any are found in its
`search for documents that reflect the research and development work for Enhertu, which includes
`the linker used in Enhertu.
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`Daiichi Sankyo Japan then performed an exhaustive company-wide search and produced over
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`reflecting the research and development of
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`Enhertu®.
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`Despite Daiichi Sankyo Japan’s substantial production, Seagen alleged on July 30 that
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`Daiichi Sankyo Japan’s production was deficient.1 On September 8, Seagen alleged deficiency
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`regarding documents concerning ADC (1) conjugation and (2) linker component selection. But,
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`in both of the Parties’ September 8 and October 1 meet and confers, Seagen focused its complaints
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`with respect to Revised Document Topic Nos. 2, 6-7
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`.2 Seagen explicitly indicated Daiichi Sankyo Japan’s
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`production would be complete should these documents and emails be produced.
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`1 Contrary to any suggestion that Daiichi Sankyo Japan evaded meet and confer requests, the
`Parties exchanged correspondence throughout August to narrow their dispute prior to meeting.
`2
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`Daiichi
`Sankyo Japan quickly produced the requested non-email documents and produced the two emails
`immediately following Seagen’s delayed October 18 confirmation that the emails would not be
`used to inappropriately expand the number of ESI custodians. (See Dkt. No. 65 ¶ 10.)
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`Case 2:20-cv-00337-JRG Document 206 Filed 11/08/21 Page 4 of 10 PageID #: 8328
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`Despite Daiichi Sankyo Japan’s agreement to
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`Seagen shifted its position again following Daiichi Sankyo Japan’s October 22 motions to compel.
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`Specifically, in the present motion, Seagen renews a dormant complaint regarding an alleged “gap”
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`in Daiichi Sankyo Japan’s production and, relying on erroneous assumptions as to the contents of
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`documents based on their file names alone,3 wrongfully accuses Daiichi Sankyo Japan of
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`withholding responsive documents.
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`III. ARGUMENT
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`A.
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`Daiichi Sankyo Japan has Produced Copious
`Documents Reflecting the Research and Development of Enhertu®
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`Seagen’s allegations appear to stem from its frustrations that Daiichi Sankyo Japan’s
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`production does not fit its litigation-driven narrative that Daiichi Sankyo Japan used Seagen’s
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`ADC technology in the development of Enhertu®. That is a deficiency in Seagen’s theory of the
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`case, not in Daiichi Sankyo Japan’s production. Following a six-month search and review of both
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`Japanese and English language documents, Daiichi Sankyo Japan’s production includes
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` detailing the research and development of Enhertu®,
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`including the documents the FDA relied upon for Enhertu®’s approval.4 These regulatory
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`documents describe Enhertu® and its development in painstaking detail. Beyond that, Daiichi
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`Sankyo Japan has produced the research documents from the Daiichi Sankyo Japan scientist, Dr.
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`Hiroyuki Naito, who invented Enhertu®. In short, Daiichi Sankyo Japan has produced far more
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`3 Seagen did not previously identify the thirteen allegedly withheld documents it now cites in its
`motion at any point during the Parties’ discussions, or at any time prior to filing this motion.
`4 See Exhibit 1, Row A. This includes topics such as the invention, dosage form, route of
`administration,
`chemistry, manufacturing
`and
`controls,
`stability,
`pharmacology,
`pharmacokinetics, toxicology, structure, design, pharmacologic properties, clinical indication,
`dose, and duration of Enhertu®.
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`Case 2:20-cv-00337-JRG Document 206 Filed 11/08/21 Page 5 of 10 PageID #: 8329
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`documents than even the FDA had before it in order to carefully assess whether Enhertu® was safe
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`and efficacious to treat patients suffering from deadly forms of cancer.
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`The alleged “gaps” in Daiichi Sankyo Japan’s production that Seagen identifies concern
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`documents related to ADC (1) conjugation and (2) linker component selection. These topics,
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`however, cannot support Seagen’s claims of infringement, including willful infringement, of the
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`patent-in-suit.5 In any event, no “gaps” exist: Daiichi Sankyo Japan has produced over 350
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`documents and 5,100 pages demonstrating (1) Enhertu®’s FDA-regulated manufacture, including
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`how Daiichi Sankyo Japan conjugates Enhertu®’s drug-linker to the cysteine amino acids on the
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`anti-HER2 antibody,6 and (2) the preceding research and invention of Enhertu®, including
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`documents from 2009 to October 2011.7 These documents illustrate that Seagen played no part in
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`the invention or development of Enhertu®; instead, they establish that (
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` (b) Dr. Naito—
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`drawing on his experience, knowledge of predecessor projects, and genius—invented Enhertu®.
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`5 The ’039 patent claims ADCs—it does not claim components of ADCs or a process for
`conjugating ADCs. (See ’039 patent at Claims 1-10.)
`6 See Exhibit 1, Row C. This includes the authoritative documents on Enhertu®’s manufacture and
`conjugation—and the development thereof—required by the FDA for regulatory approval, as well
`as in-house development reports on the foregoing.
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`7 See Exhibit 1, Row D. This includes documents from
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` in-house research summaries, presentations, and lab notebooks
`reflecting preceding research between 2009 to October 2011, and contemporaneous documents
`showing the invention of Enhertu®.
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`Case 2:20-cv-00337-JRG Document 206 Filed 11/08/21 Page 6 of 10 PageID #: 8330
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`Attempting to shore up its claim that documents related to ADC conjugation and linker
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`component selection are missing, Seagen identified only a list of 13 documents—seemingly based
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`on unwarranted inferences from their file names alone—allegedly responsive to Revised
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`Document Topic Nos. 2, 6-7 and withheld by Daiichi Sankyo Japan. Remarkably, Seagen glosses
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`over the fact that these documents are not even related to ADC conjugation or linker component
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`selection. Seagen also neglected to inform Daiichi Sankyo Japan that it believes these documents
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`should have been produced.8 Notwithstanding their irrelevance and Seagen’s disregard for the
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`Court’s procedures (see L. R. C-V 7(h)), however, Daiichi Sankyo Japan produced all the
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`identified documents in its possession in the spirit of compromise.9
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`That Seagen is dissatisfied with the facts in the documents Daiichi Sankyo Japan produced
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`does not mean it improperly withheld documents. The Court should not reward Seagen’s delayed
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`fishing expedition, especially in light of Daiichi Sankyo Japan’s extensive responsive production
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`and the late stage of this action.
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`B.
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`Seagen Inappropriately Seeks to Circumvent this
`Court’s Prior Rulings and Expand the Scope of Discovery
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`After focusing its entire motion on the agreed upon Revised Document Topic Nos. 2, 6-7,
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`in the concluding sentences, Seagen (with no explanation) tries to fold Document Topic Nos. 50-
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`52 into its request. (Dkt. No. 187 at 7.) Seagen’s Document Topics Nos. 50-52, however, are
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`inappropriate as they request documents from the Parties’ arbitration that are protected by the
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`arbitration’s Protective Order. Specifically, Document Topic Nos. 50-52 recite:
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`8 The Parties therefore did not have the opportunity to confer regarding these particular documents,
`which would have elucidated that the identified documents are not responsive.
`9 After an extensive search, Daiichi Sankyo Japan located 12 of the 13 requested documents. Those
`12 documents have been produced.
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`Case 2:20-cv-00337-JRG Document 206 Filed 11/08/21 Page 7 of 10 PageID #: 8331
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`Seagen Document Topic No. 50: All documents produced by DSC in Seagen Inc. v. Daiichi
`Sankyo Co., Ltd., American Arbitration Association, No. 01-19-0004-0115 (Brown, Arb.), that
`relate to the structure of the linker used in DSC’s ADCs, including DS-8201.
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`Seagen Document Topic No. 51: All documents produced by DSC in Seagen Inc. v. Daiichi
`Sankyo Co., Ltd., American Arbitration Association, No. 01-19-0004-0115 (Brown, Arb.), that
`relate to the composition of the linker used in DSC’s ADCs, including DS-8201.
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`Seagen Document Topic No. 52: All documents produced by DSC in Seagen Inc. v. Daiichi
`Sankyo Co., Ltd., American Arbitration Association, No. 01-19-0004-0115 (Brown, Arb.), that
`relate to the development of the linker used in DSC’s ADCs, including DS-8201.
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`As Daiichi Sankyo Japan explained to Seagen in a July 29 letter (see Exhibit 2), the Court’s
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`February 9 Discovery Order requires the Parties to seek leave from Judge Garrett E. Brown before
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`obtaining or using in this case any documents produced in the arbitration. (Dkt. No. 51 ¶ 12(b).)
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`Because Seagen has not done so, Seagen’s requests improperly circumvent the Court’s Discovery
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`Order. Moreover, Seagen inappropriately conflates the scope of the arbitration and this action,
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`and seeks discovery on products beyond the single accused product Enhertu®.
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`Seagen never responded to Daiichi Sankyo Japan’s July 29 letter,10 and its motion nowhere
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`acknowledged Paragraph 12(b) of this Court’s Discovery Order. Putting aside Seagen’s failure to
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`abide by that provision, and its failure to confer on these requests, Daiichi Sankyo Japan advised
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`Seagen on July 29 that Daiichi Sankyo Japan is not withholding any documents that reflect the
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`research and development of Enhertu® produced in the arbitration. As reflected by Seagen’s
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`inaction on this point for the past three months, there is nothing here for this Court to do.
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`C.
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`Seagen Alleges Misconduct to Shield its Own Behavior
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`Seagen’s allegations of misconduct are meritless. As recently as the Parties’ October 1
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`meet and confer, Seagen indicated it was willing to resolve its requests if Daiichi Sankyo Japan
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`10 Although Seagen later requested specific documents produced in the arbitration it claimed were
`responsive to its Revised Document Topic Nos. 2, 6-7, it has not again raised Document Topic
`Nos. 50-52 to Daiichi Sankyo Japan.
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`Case 2:20-cv-00337-JRG Document 206 Filed 11/08/21 Page 8 of 10 PageID #: 8332
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`produced two emails produced in the arbitration. The Parties reached an agreement on October 18
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`for the production of these emails. Yet, on October 29, Seagen reneged on this resolution,
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`articulating new alleged deficiencies with Daiichi Sankyo Japan’s production.
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`Daiichi Sankyo Japan has operated in accordance with the Court’s Docket Control Order
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`and Discovery Order. Seagen’s suggestion that Daiichi Sankyo Japan has produced only a
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`“trickle” of responsive documents and engaged in delay tactics11 is patently false; prior to the
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`Court’s July 16 deadline for substantial completion of the production of documents, Daiichi
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`Sankyo Japan produced
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` responsive to Seagen Revised
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`Document Topic Nos. 2, 6-7. (See Exhibit 1, Row B.) Seagen’s cited cases calling for Rule 37
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`sanctions are thus inapposite,12 and Seagen cannot support Rule 37’s bad faith requirement. See
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`Innovation Scis., LLC v. HTC Corp., 2020 WL 4536053, at *2-3 (E.D. Tex. Aug. 6, 2020). Even
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`if the Court were to determine that Daiichi Sankyo Japan must produce additional documents,
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`sanctions still would not be appropriate, as Daiichi Sankyo Japan always acted in good faith.13
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`Seagen’s argument is unsupported by the evidence, and therefore must fail.
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`IV.
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` CONCLUSION
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`For all the reasons articulated above, Seagen’s motion to compel should be denied.
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`11 The Parties have met and conferred throughout this action promptly after crystallizing the
`disputed issues in writing. Any supposed delay has been the direct result of Seagen ignoring
`Daiichi Sankyo Japan’s repeated questions.
`12 In Weatherford, the defendant produced only 22 responsive pages. Weatherford Tech. Holdings,
`LLC v. Tesco Corp., 2018 WL 4620634, at *2-3 (E.D. Tex. Apr. 27, 2018). In Marquis,
`defendants’ failure to fulfill discovery obligations forced the court to hold eight hearings and issue
`four Orders compelling production. See Marquis v. Sadeghian, 2021 WL 4148755, at *4, *8 (E.D.
`Tex. Sept. 13, 2021). The facts differ drastically here.
`13 See Alexander v. Martin, 2010 WL 11530939, at *3-4 (E.D. Tex. Apr. 21, 2010) (declining to
`impose sanctions following the plaintiff’s allegations that the defendant violated the parties’
`production agreement—reached in response to the plaintiff’s first motion to compel—despite
`ordering additional production).
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`Case 2:20-cv-00337-JRG Document 206 Filed 11/08/21 Page 9 of 10 PageID #: 8333
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`Dated: November 4, 2021
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`Respectfully submitted,
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`/s/ Preston K. Ratliff II
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`Deron R. Dacus
`State Bar No. 00790553
`The Dacus Firm, P.C.
`821 ESE Loop 323, Suite 430
`Tyler, Texas, 75701
`+1 (903) 705-1117
`+1 (903) 581-2543 facsimile
`ddacus@dacusfirm.com
`
`J. Mark Mann
`State Bar No. 12926150
`mark@themannfirm.com
`MANN | TINDEL | THOMPSON
`300 West Main Street
`Henderson, Texas 75652
`(903) 657-8540
`(903) 657-6003 (fax)
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`Attorneys for Defendant Daiichi Sankyo Company,
`Limited
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`OF COUNSEL:
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`Preston K. Ratliff II
`Joseph M. O’Malley, Jr.
`Ashley N. Mays-Williams
`Paul Hastings LLP
`200 Park Avenue
`New York, NY 10166
`(212) 318-6000
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`Jeffrey A. Pade
`Paul Hastings LLP
`2050 M Street NW
`Washington, DC 20036
`(202) 551-1700
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`Attorneys for Defendant Daiichi Sankyo Company,
`Limited
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`Case 2:20-cv-00337-JRG Document 206 Filed 11/08/21 Page 10 of 10 PageID #: 8334
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`CERTIFICATE OF SERVICE
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`The undersigned hereby certifies that all counsel of record who have consented to
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`electronic service are being served with a copy of this document via electronic mail on November
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`4, 2021.
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`/s/ Preston K. Ratliff II
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