Case 2:20-cv-00337-JRG Document 193 Filed 11/02/21 Page 1 of 10 PageID #: 8123
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`IN THE UNITED STATES DISTRICT COURT
`EASTERN DISTRICT OF TEXAS
`MARSHALL DIVISION
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`Civil Action No. 2:20-CV-00337-JRG
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`SEAGEN INC.,
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`v.
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`Plaintiff,
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`DAIICHI SANKYO CO., LTD.,
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`Defendant,
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`ASTRAZENECA PHARMACEUTICALS LP, and
`ASTRAZENECA UK LTD,
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` Intervenor-Defendants.
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`SEAGEN INC.’S RENEWED MOTION TO
`COMPEL DAIICHI SANKYO CO., LTD.’S
`PRODUCTION OF DEVELOPMENT
`DOCUMENTS AND FOR
`RELIEF UNDER RULE 37
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`Case 2:20-cv-00337-JRG Document 193 Filed 11/02/21 Page 2 of 10 PageID #: 8124
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`I.
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`INTRODUCTION
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`Seagen renews its motion to compel production of development documents for the linker
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`technology in the accused product, DS-8201 (Enhertu®). These are documents DSC agreed to
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`produce in return for Seagen’s withdrawal of its prior motion, and the Court based its Order on
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`that agreement. Despite its prior agreement and this Court’s Order, DSC still has not completed
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`its production of these documents, and it has avoided engaging with Seagen in what appears to be
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`a “run out the clock” strategy of evading its discovery obligations. DSC should be ordered to
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`produce the documents and to certify that its production is complete.
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`II.
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`BACKGROUND
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`A.
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`Factual background
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`The asserted patent claims antibody-drug conjugates (ADCs) with a particular type of
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`linker—the portion of the ADC that links the antibody to the drug. Seagen alleges that DSC’s
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`Enhertu ADC product infringes the patent based on the structure of its linker. Seagen also asserts
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`that DSC’s infringement is willful because, among other things, DSC was aware of Seagen’s patent
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`applications relating to the asserted patent and relied on confidential aspects of Seagen’s linker
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`technology in the development of the linker used in Enhertu. (Compl. ¶ 27.)
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`DSC asserts in its objections to Seagen’s documents requests that it developed its linker
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`independently, and that its own scientists were solely responsible for its invention. (See Ex. A.1)
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`While independent development is not a defense to patent infringement, the circumstances
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`surrounding this purported defense are an issue that Seagen should be permitted to test through
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`discovery. In addition to rebutting DSC’s assertion, the documents Seagen seeks are relevant to
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`showing how the accused product meets the limitations of the asserted claims and the value of the
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`technology.
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`1 Exhibit A is an excerpt from DSC’s Objections to Seagen’s Document Requests dated March 16,
`2021.
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`Case 2:20-cv-00337-JRG Document 193 Filed 11/02/21 Page 3 of 10 PageID #: 8125
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`B.
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`Seagen’s efforts to obtain discovery
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`Drawing on its own files and on public information, Seagen determined that several DSC
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`scientists with prior access to Seagen’s linker technology were involved in the development of
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`Enhertu.2 Seagen included these individuals in a January 21, 2021 letter to DSC regarding
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`documents that Seagen expected to see in DSC’s production. Seagen also requested Enhertu
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`development documents that refer to Seagen or to the inventors of the asserted patent.
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`On April 16, 2021, after DSC failed to respond to Seagen’s repeated requests to meet and
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`confer and failed to produce the requested documents, Seagen filed a motion to compel production
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`of linker development documents. (Dkt. 79.) Shortly after Seagen filed its motion, DSC reached
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`out seeking to negotiate its withdrawal. In exchange for the withdrawal of the motion, DSC agreed
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`to produce the following development documents:
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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.
`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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`Seagen’s withdrawal of its motion and this Court’s Order granting that withdrawal were
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`predicated on DSC’s compliance with its commitment to produce these documents. (See Dkt. 92;
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`2 See, e.g., Ogitani et al., 107(7) CANCER SCI. 1039 (2016); Ogitani et al., 22 CLIN. CANCER
`RES. 5097 (2016); and Iwata et al., 17(7) MOLECULAR CANCER THERAPEUTICS 1494 (2018).
`2
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`Case 2:20-cv-00337-JRG Document 193 Filed 11/02/21 Page 4 of 10 PageID #: 8126
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`Dkt. 93.) It has now been more than six months since the Court’s Order, and despite substantial
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`further meet and confer, DSC continues to withhold many documents responsive to these requests.
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`For example, DSC has not produced documents that show how DSC developed its protocols for
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`conjugating its linker to cysteine amino acids on an antibody—one of the limitations of the ’039
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`patent’s independent claim—and how it selected the components in its linker from late 2009/early
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`2010 to October 2011. Without these documents, there is a gap in the development timeline for
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`DSC’s linker technology—a gap that falls during a period when Seagen was providing large
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`amounts of information to DSC on ADC linkers as part of the parties’ collaboration.
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`Seagen raised these continued deficiencies three months ago, on July 30, 2021. But DSC
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`declined every invitation to meet and confer about them until September 8. (See Ex. B.) During
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`that meet and confer, DSC would not commit to remedying its production deficiencies. In light of
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`DSC’s continued withholding of relevant documents, the parties held another meet and confer on
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`October 1 to discuss DSC’s discovery failures, during which DSC again refused to acknowledge its
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`production deficiencies. Since the October 1 meet and confer between the parties, DSC still has
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`not produced documents from the gap in the development timeline for its linker technology, or at
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`least certified that it could not locate them after a reasonable search, despite Seagen’s repeated
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`requests.
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`III.
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`ARGUMENT
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`Seagen’s renewed motion seeks an order compelling DSC to produce documents regarding
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`its development of the accused product and its reliance on Seagen technology in that development.
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`The Court should also find that DSC violated this Court’s Discovery Order, a violation further
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`exacerbated by its refusal to comply with its agreement that was the predicate for the Order on
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`Seagen’s motion to withdraw. See Fed. R. Civ. P. 37(b).
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`Case 2:20-cv-00337-JRG Document 193 Filed 11/02/21 Page 5 of 10 PageID #: 8127
`Case 2:20-cv-00337-JRG Document 193 Filed 11/02/21 Page 5 of 10 PagelD #: 8127
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`A.
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`DSC cannotavoidits obligation to produce documents relevantto this
`case
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`Under the Local Rules, documents relevant to the parties’ claims and defenses include:
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`“information that is likely to have an influence on or affect the outcome of a claim or defense”;
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`“information that deserves to be considered in the preparation, evaluation, or trial of a claim or
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`defense”; and even “information that would not support the disclosing parties’ contentions.”
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`L.R. CV-26(d). DSC cannot reasonably argue that information relating to the developmentof the
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`accused linker technology used in Enhertufalls outside these broad categories. This kind of
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`informationis “routinely relevant in patent infringementsuits.” See Weatherford Tech. Holdings,
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`LLC v. Tesco Corp., No. 2:17-CV-00456-JRG, 2018 WL 4620634, at *2 (E.D. Tex. Apr. 27, 2018);
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`ICON Health & Fitness, Inc. v. Horizon Fitness, Inc., No. 5:08CV26, 2009 WL 10677745, at *3
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`(E.D. Tex. Mar. 16, 2009) (finding “research and development documents relevant”). Yet despite
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`the documents’ obvious relevance, DSC continues to withhold probative linker development
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`documents, including those with information on how it tested and selected componentsofits linker.
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`DSC has withheld development documents Seagen knowsto exist, because they were cited in other
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`documents that DSC produced. Seagen identifies at least the following files as documents known
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`to be withheld by DSC:
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`° es - cited in DSC_ENHERTU_00372418
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`° EE — cited in DSC_ENHERTU_00373946
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`° — <ited in DSC_ENHERTU_00373946
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`cic
`DSC_ENHERTU_00376209
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`° NS—cited in DSC_ENHERTU_00377426
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` — cited in DSC_ENHERTU_00377444
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`°ms cited in DSC_ENHERTU_00377444
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`Case 2:20-cv-00337-JRG Document 193 Filed 11/02/21 Page 6 of 10 PageID #: 8128
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`•
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`•
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`•
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`•
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`•
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` – cited in DSC_ENHERTU_00377452
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` - cited in DSC_ENHERTU_00378275
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` – cited in DSC_ENHERTU_00383959
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` – cited in DSC_ENHERTU_00383959
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` – cited in
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` – cited in DSC_ENHERTU_00387041
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`DSC_ENHERTU_00386910
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`The produced documents suggest there are many others (without identifying specific file names,)
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`that have also been withheld.
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`DSC cannot rely on relevance objections to explain these deficiencies. It already agreed to
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`produce them. (See Dkt. 92; Dkt. 89.) Given the agreement to produce these documents, any
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`relevance objections have been waived. See RealPage, Inc. v. Enter. Risk Control, LLC, No. 4:16-
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`CV-00737, 2017 WL 1165688, at *5 (E.D. Tex. Mar. 29, 2017) (“Based on Enterprise's agreement
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`[to produce documents responsive to plaintiff’s request], the Court finds Enterprise has waived its
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`objection on relevance grounds.”)
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`In any event, these documents are relevant not only to infringement and the value of the
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`patented technology, but also to disputing DSC’s purported defense of independent development.
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`For example, DSC contends that it developed its linker without relying on Seagen’s technology.
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`(See Ex. A.) Seagen disputes that contention, and reasonably believes the requested documents
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`would refute it. Seagen is at least entitled to discovery to test DSC’s defense. Under the Local
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`Rules, documents that “would not support” DSC’s defense are relevant, and must be produced.
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`L.R. CV-26(d)(1). As to willfulness, whether DSC relied on or copied aspects of Seagen’s linker
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`technology is also highly relevant. Seagen’s complaint specifically alleges that DSC was “aware of
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`Seagen’s linker technology, inquired about it, and directly compared it to the linkers in DSC’s
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`infringing products.” (Compl. ¶ 27.) In Barry v. Medtronic, Inc., this Court held that such copying
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`of “the ideas or design of another” is relevant to willfulness and enhanced damages “regardless of
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`when [the] patents might have issued.” 250 F. Supp. 3d 107, 112, 114 (E.D. Tex. 2017) (citation
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`omitted) (“A patent need not have issued before the ideas of that inventor can be copied in bad
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`faith.”). The requested documents will be highly probative of this issue.
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`B.
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`DSC’s discovery misconduct should not be countenanced
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`DSC’s “run out the clock” approach to discovery is particularly egregious. Seagen first
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`requested these documents at the start of the year. DSC initially refused to provide them, and then
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`ignored multiple requests to meet and confer. Seagen moved to compel DSC’s production in April,
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`after finally getting DSC to discuss the issue. (Dkt. 79.) DSC agreed to produce the documents
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`only after Seagen filed its motion. Based on this agreement, Seagen withdrew its motion, and the
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`Court entered an order reflecting the agreement. (Dkt. 92; Dkt. 93.)
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`In the more than six months since then, however, DSC has violated that agreement (not to
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`mention this Court’s Discovery Order), producing only a trickle of responsive documents. After
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`Seagen again raised the issue in July and received no substantive response from DSC, Seagen
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`sought to meet and confer, but DSC ignored Seagen’s repeated requests until finally agreeing to
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`meet and confer first on September 8 and then again a month later on October 1 after Seagen again
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`raised DSC’s production failures. During the parties’ meet and confers, Seagen outlined how DSC
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`was deficient in its obligation to produce responsive documents regarding development of its ADC
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`linker. Seagen asked DSC to decide by October 8 whether it would produce the documents it had
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`agreed to produce last April. DSC refused to do so.
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`DSC should not be allowed to benefit from its discovery gamesmanship. Rule 37(b) of the
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`Federal Rules of Civil Procedure permits this Court to impose penalties on parties that “fail[] to
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`obey an order to provide or permit discovery” (Fed. R. Civ. P. 37(b)(2)(A)) or that use delay as an
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`inappropriate litigation strategy. See, e.g., Weatherford Tech., 2018 WL 4620634, at *3; Marquis v.
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`Sadeghian, No. 4:19-CV-626-RWS-KPJ, 2021 WL 4148755, at *8 (E.D. Tex. Sept. 13, 2021).
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`DSC has engaged in delay tactics since the start of discovery, including by withholding relevant
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`documents, declining requests for meet and confers, and now refusing to produce documents it
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`agreed to produce. These tactics give cause for doubt that DSC has made a complete production on
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`any issue in this case; it certainly has not for development documents. Given the quickly
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`approaching close of fact discovery, the Court should require DSC to (1) complete the production
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`of documents responsive to Seagen’s Requests 2, 6-7, and 50-52, and (2) certify that its production
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`is complete. And, the Court should use its inherent power and authority under Rule 37 to order
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`DSC to pay the reasonable expenses, including attorney’s fees, caused by DSC’s failure to comply
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`with the Court’s Discovery Order.
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`Dated: October 29, 2021
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`By: /s/ Michael A. Jacobs
`Michael A. Jacobs
`MJacobs@mofo.com
`Matthew A. Chivvis
`MChivvis@mofo.com
`MORRISON & FOERSTER LLP
`425 Market Street
`San Francisco, CA 94105
`Telephone: 415.268.7000
`Facsimile: 415.268.7522
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`Bryan Wilson
`BWilson@mofo.com
`Pieter S. de Ganon
`PdeGanon@mofo.com
`MORRISON & FOERSTER LLP
`755 Page Mill Road
`Palo Alto, California 94304-1018
`Telephone: 650.813.5600
`Facsimile: 650.494.0792
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`Melissa R. Smith
`Texas State Bar No. 24001351
`melissa@gillamsmithlaw.com
`GILLAM & SMITH, LLP
`303 South Washington Avenue
`Marshall, Texas 75670
`Telephone: 903.934.8450
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`Case 2:20-cv-00337-JRG Document 193 Filed 11/02/21 Page 9 of 10 PageID #: 8131
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`Facsimile: 903.934.9257
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`Of Counsel:
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`T. John Ward, Jr.
`Texas State Bar No. 00794818
`jw@wsfirm.com
`Charles Everingham IV
`Texas State Bar No. 00787447
`ce@wsfirm.com
`Andrea L. Fair
`Texas State Bar No. 24078488
`andrea@wsfirm.com
`WARD, SMITH & HILL, PLLC
`1507 Bill Owens Parkway
`Longview, Texas 75604
`Telephone: 903.757.6400
`Facsimile: 903.757.2323
`Attorneys for Plaintiff Seagen Inc.
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`Case 2:20-cv-00337-JRG Document 193 Filed 11/02/21 Page 10 of 10 PageID #: 8132
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`CERTIFICATE OF SERVICE
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`The undersigned hereby certifies that all counsel of record who are deemed to have consented
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`to electronic service are being served with a copy of the foregoing document via the Court’s CM/ECF
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`system per Local Rule CV-5(a)(3) this October 29, 2021.
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`/s/ Melissa R. Smith
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`CERTIFICATE OF CONFERENCE
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`On September 8, 2021, counsel for Seagen, with Michael Jacobs as lead counsel and Travis
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`Underwood as local counsel, met and conferred via telephone with counsel for Daiichi Sankyo Co.,
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`Ltd., with Preston Ratliff as lead counsel and Mark Mann as local counsel. On October 1, 2021,
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`counsel for Seagen, with Michael Jacobs as lead counsel and Travis Underwood as local counsel,
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`again met and conferred via telephone with counsel for Daiichi Sankyo Co., Ltd., with Preston Ratliff
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`as lead counsel and Mark Mann as local counsel. The parties were unable to reach agreement and
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`have reached an impasse, leaving an open issue for the Court to resolve. This motion is opposed by
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`Defendants.
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`/s/ Michael A. Jacobs
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`/s/ Melissa R. Smith
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