Case 2:20-cv-00337-JRG Document 84 Filed 04/21/21 Page 1 of 10 PageID #: 2714
`
`IN THE UNITED STATES DISTRICT COURT
`EASTERN DISTRICT OF TEXAS
`MARSHALL DIVISION
`
`SEAGEN INC.,
`
`
`v.
`
`Plaintiff,
`
`DAIICHI SANKYO CO., LTD.,
`
`Defendant.
`
`Civil Action No. 2:20-CV-00337-JRG
`
`
`
`SEAGEN INC.’S MOTION TO COMPEL
`DAIICHI SANKYO CO., LTD.’S DISCOVERY RESPONSES AND PRODUCTION
`
`sf-4454178
`
`

`

`Case 2:20-cv-00337-JRG Document 84 Filed 04/21/21 Page 2 of 10 PageID #: 2715
`
`I.
`
`INTRODUCTION
`
`Plaintiff Seagen Inc. (“Seagen”) moves to compel Defendant Daiichi Sankyo Co., Ltd.
`
`(“DSC”) to provide discovery regarding research and development of the accused product,
`
`Enhertu® (also known as “DS-8201”). DSC refuses to produce any research and development
`
`documents aside from limited portions of its FDA submissions, even though research and
`
`development documents are directly relevant to both Seagen’s infringement claims and DSC’s
`
`defenses.
`
`II.
`
`BACKGROUND
`
`The asserted patent, U.S. Patent No. 10,808,039 (the “’039 patent”), covers an advanced
`
`form of linker for use in antibody-drug conjugates (ADCs). The linker in an ADC is the portion of
`
`the ADC that links the antibody to the drug, and is a critical part of the ADC. Seagen alleges that
`
`the linker used in DSC’s Enhertu product infringes the ’039 patent.
`
`
`
`
`
` While Seagen does not agree
`
`independent development is a defense to patent infringement, DSC’s assertion has made it a central
`
`issue that Seagen is allowed to test through discovery. Further, Seagen alleges that DSC’s
`
`infringement of the ’039 patent is willful, in part because DSC knew of one or more parent
`
`applications of the ’039 patent at least since 2008. (Compl. ¶¶ 14, 27.)
`
`Seagen also asserts that DSC relied on confidential aspects of Seagen’s linker technology in
`
`the development of the linker used in Enhertu—an allegation that DSC denies. (Compl. ¶ 27.)
`
`DSC learned this information during a 10-year relationship in which Seagen provided DSC with
`
`extensive access to its proprietary and confidential linker technology. Unbeknownst to Seagen,
`
`1 Exhibit A is a compilation of excerpts from DSC’s Objections to Seagen’s Document Requests (Nos. 2, 6, and 7) dated
`March 16, 2021.
`
`1
`
`

`

`
`Case 2:20-cv-00337-JRG Document 84 Filed 04/21/21 Page 3 of 10 PageID #: 2716
`
`
`
`
`DSC began working on its own ADCs in the midst of this relationship.2 The first approved product
`
`resulting from this work was Enhertu.3
`
`
`
`
`
`
`
` Several of
`
`these individuals also appear in publications relating to the development of Enhertu.4 To test
`
`DSC’s allegations regarding the development of Enhertu, Seagen included these individuals in a
`
`January 21 letter to DSC regarding documents that Seagen expected to see in DSC’s initial and
`
`additional disclosures production. Seagen also requested Enhertu development documents that
`
`refer to Seagen or the inventors of the asserted patent.
`
`DSC did not produce the requested documents on Enhertu’s development in its February 10
`
`initial disclosures or in any additional disclosures. DSC only provided excerpts of its post-
`
`development submissions to the FDA, and certain product package inserts. Based on the narrow
`
`scope of DSC’s production, Seagen requested a lead and local meet and confer which was held on
`
`February 19. In that discussion, DSC said it was still reviewing Seagen’s January 21 letter and
`
`would respond soon. Seagen followed up on March 2, 8, 9, 10, 11, and 12. DSC provided no
`
`substantive response.
`
`On March 16, almost two months after Seagen’s letter, DSC finally provided its responses
`
`and objections. (See Ex. A.)
`
`
`
`
`
`
`
`
`2 A. Yver et al., The art of innovation: clinical development of trastuzumab deruxtecan and redefining how antibody-
`drug conjugates target HER2-positive cancers, 31 Annals of Oncology 430 (2020).
`3 See, e.g., R&D Day 2019 at 42, Daiichi Sankyo (Dec. 17, 2019),
`https://www.daiichisankyo.com/files/investors/library/materials/2019/pdf/R%20and%20D%20Day%202019_E.pdf.
`4 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
`
`
`
`

`

`
`Case 2:20-cv-00337-JRG Document 84 Filed 04/21/21 Page 4 of 10 PageID #: 2717
`
`
`
`
`
` However, DSC did not actually produce the documents.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`The parties held a further lead and local meet and confer on March 19. During the meet
`
`and confer, Seagen explained the relevance of Enhertu development documents in detail, including
`
`to infringement and willfulness, as well as to rebutting DSC’s independent development and
`
`anticipation defenses. Seagen also addressed DSC’s objections. Despite its earlier offer to meet
`
`and confer, DSC still refused to commit to producing any additional documents. Seagen asked
`
`DSC to advise by April 6 whether its position on the remaining development documents had
`
`changed. DSC did not respond.
`
`
`
`III.
`
`ARGUMENT
`
`Seagen seeks an order compelling DSC to produce documents regarding the development of
`
`the accused product, and how closely the product relates to Seagen’s own products and technology.
`
`These documents are indisputably relevant and should have been produced even without the need
`
`for Seagen to request them specifically, which Seagen did regardless months ago. In response,
`
`DSC only offers to produce a very small subset of documents that it contends would support its
`
`independent development defense, while refusing to produce documents that would allow Seagen to
`
`test the defense. Even for those documents, DSC has not stated when it will produce them. DSC’s
`
`excuses appear to be a stalling tactic and DSC should be ordered to produce the documents.
`
`
`
`3
`
`

`

`
`Case 2:20-cv-00337-JRG Document 84 Filed 04/21/21 Page 5 of 10 PageID #: 2718
`
`
`
`
`
`A.
`
`DSC Cannot Avoid Its Obligation to Produce All Relevant Documents to
`This Case
`
`DSC has violated the requirement that it produce all documents relevant to the parties’
`
`claims and defenses. (See Dkt. 51 ¶ 3(b).) Discovery in the Eastern District of Texas is broad.
`
`Under the Local Rules, documents relevant to the parties’ claims and defenses include:
`
`“information that is likely to have an influence on or affect the outcome of a claim or defense”;
`
`“information that deserves to be considered in the preparation, evaluation, or trial of a claim or
`
`defense”; and even “information that would not support the disclosing parties’ contentions.”
`
`L.R. CV-26(d). DSC cannot reasonably argue that information relating to the development of the
`
`accused product, Enhertu, falls outside these broad categories. This kind of information is
`
`“routinely relevant in patent infringement suits.” See Weatherford Tech. Holdings, LLC v. Tesco
`
`Corp., No. 2:17-CV-00456-JRG, 2018 WL 4620634, at *2 (E.D. Tex. Apr. 27, 2018); ICON Health
`
`& Fitness, Inc. v. Horizon Fitness, Inc., No. 5:08CV26, 2009 WL 10677745, at *2–3 (E.D. Tex.
`
`Mar. 16, 2009) (finding “research and development documents relevant”).
`
`DSC cannot claim ignorance that Enhertu development documents are relevant to the claims
`
`and defenses in this case. Seagen advised DSC, in a January 21 letter, that among the documents
`
`Seagen expects to see in DSC production are:
`
`• Document Topic No. 2: All documents that reflect DSC’s research and development work
`for the linker used in [Enhertu], including without limitation, documents reflecting the work
`of [certain DSC scientists] relating to ADC linkers.
`
`• Document Topic No. 6: All documents that refer to Seattle Genetics, SGI, Seagen, or
`any other name used within DSC to refer to Seagen or any of Seagen’s ADC research
`and/or development work, including without limitation, documents that refer to
`information obtained from Seagen.
`
`• Document Topic No. 7: All documents that refer to the named inventors of the patent-in-
`suit.
`
`In meet and confer, Seagen sought compromise. Seagen agreed that, for Requests 6 and 7,
`
`it was only seeking documents that concern the development of the linker used in Enhertu. Also in
`
`
`
`4
`
`

`

`
`Case 2:20-cv-00337-JRG Document 84 Filed 04/21/21 Page 6 of 10 PageID #: 2719
`
`
`
`
`response to DSC’s objections,
`
`
`
`
`
`
`
` Yet DSC has thus far refused to produce any of
`
`these documents, even though they are relevant under Local Rule CV-26(d).
`
`These documents are directly relevant to refuting DSC’s defenses.
`
`
`
`
`
`
`
` Seagen disputes these contentions, and reasonably
`
`believes the requested documents would refute them. Under the Local Rules, documents that
`
`“would not support” these assertions are relevant, and must be produced. L.R. CV-26(d)(1).
`
`Enhertu development documents are also relevant to whether Enhertu meets all the
`
`limitations of the asserted claims and whether DSC is a willful infringer—both of which are in
`
`dispute. As to willfulness, whether DSC relied on or copied aspects of Seagen’s linker technology
`
`will be particularly relevant. Although not required to, Seagen specifically alleged that DSC was
`
`“aware of Seagen’s linker technology, inquired about it, and directly compared it to the linkers in
`
`DSC’s infringing products.” (Compl. ¶ 27.) In Barry, this Court held that such copying of “the
`
`ideas or design of another” is relevant to willfulness and enhanced damages “regardless of when
`
`[the] patents might have issued.” Barry v. Medtronic, Inc., 250 F. Supp. 3d 107, 112, 114 (E.D.
`
`Tex. 2017) (citation omitted) (“A patent need not have issued before the ideas of that inventor can
`
`be copied in bad faith.”). Thus, the issue date of the ’039 patent is no bar to this discovery,
`
`especially since the patent claims priority to 2003 and Enhertu’s development falls in the interim.
`
`Moreover, Seagen alleges that DSC knew of parent applications for the ’039 patent since at least
`
`2008, which supports that DSC was at least reckless in development of Enhertu. (Compl. ¶¶ 14
`
`
`
`5
`
`

`

`
`Case 2:20-cv-00337-JRG Document 84 Filed 04/21/21 Page 7 of 10 PageID #: 2720
`
`
`
`
`27.) As this Court noted, even “recklessness towards copying” can merit enhancement. Barry, 250
`
`F. Supp. 3d at 112. In light of these allegations, DSC Enhertu development documents are relevant
`
`and cannot be withheld from production.
`
`Despite its obligation to produce all relevant documents, DSC has produced only a handful
`
`of documents relating to jurisdiction and venue since its initial and additional disclosures. The total
`
`number of documents it has produced to date is just 813. That DSC has pending motions to dismiss
`
`or transfer is no excuse for non-production. L.R. CV-26(a) (“Absent a court order to the contrary, a
`
`party is not excused from responding to discovery because there are pending motions to dismiss, to
`
`remand, or to change venue.”).
`
`B.
`
`DSC’s Excuses for Non-Production Lack Merit
`
`DSC makes a number of meritless objections in an attempt to avoid producing Enhertu
`
`development documents.
`
`
`
`
`
` All of these arguments fail.
`
`Whether the documents were responsive in the arbitration is irrelevant to whether they need
`
`to be produced here. The requested documents are relevant to this case and Seagen seeks them for
`
`use here. Should DSC produce any documents that are also relevant to the arbitration, the Court
`
`has put in place a procedure for requesting such cross-use. (Dkt. 51 ¶ 12(b).) DSC can raise any
`
`appropriate arguments if Seagen seeks to do so. DSC’s hypothetical and premature concern has no
`
`bearing on whether the documents should be produced now, for use in this action.
`
`DSC’s fear that Seagen’s requests may reach other products currently under development is
`
`also unfounded. (Ex. A at 1.) As Seagen clarified for DSC, Seagen seeks discovery regarding the
`
`development of the linker used in Enhertu; its requests are not directed to DSC’s other pipeline
`
`products. If there is overlap because Enhertu development documents also discuss the development
`6
`
`
`
`

`

`
`Case 2:20-cv-00337-JRG Document 84 Filed 04/21/21 Page 8 of 10 PageID #: 2721
`
`
`
`
`other products, however, DSC should not be allowed to withhold them.
`
`
`
` DSC has an entire section of its website devoted to describing its
`
`product development capabilities.5 DSC has a “Global Head of R&D,” who released an article
`
`describing these capabilities.6 DSC’s declarant, Hiroaki Miki, also used this term in support of
`
`DSC’s transfer motion, conceding that DSC (not its subsidiary) “develop[ed] . . . Enhertu®.”
`
`(Dkt. 24-1 ¶ 2.) As these statements reveal, development is a commonly understood term in the
`
`pharmaceutical industry.
`
`Nor should the Court credit DSC’s complaints about undue burden.
`
` overstates the relevant time frame.
`
`
`
`
`
`
`
`7 Further, that a Japanese company has documents in
`
`Japanese cannot be a basis to deny discovery of otherwise relevant documents. DSC is represented
`
`by sophisticated counsel, with an office in Japan. Reviewing documents in Japanese for production
`
`is manageable and appropriate. To hold otherwise would allow DSC to shirk its discovery
`
`obligations on almost every issue in this case.
`
`IV.
`
`CONCLUSION
`
`DSC seeks to avoid producing relevant documents under the guise that Seagen’s requests are
`
`irrelevant and unduly burdensome. But Seagen’s requests seek routine discovery regarding the
`
`development of the accused product, and will likely show that DSC scientists used Seagen ideas in
`
`doing so. That the documents may be unhelpful to DSC is not a basis to withhold them.
`
`
`5 See, e.g., Research & Development, Daiichi Sankyo, https://www.daiichisankyo.com/rd/.
`6 See Building on our ADC success: the challenge and promise of R&D at Daiichi Sankyo (Oct. 9, 2020),
`https://www.daiichisankyo.com/our_stories/detail/index_4076.html.
`7 Daiichi Sankyo Group Value Report 2018 at 20,
`https://www.daiichisankyo.com/files/investors/library/annual_report/index/pdf/ds_value2018_Eng.pdf (“Research and
`development on ADC started in 2010.” (emphasis added)).
`7
`
`
`
`

`

`
`
`
`
`
`
`
`
`Case 2:20-cv-00337-JRG Document 84 Filed 04/21/21 Page 9 of 10 PageID #: 2722
`
`Dated: April 16, 2021
`
`
`
`
`
`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
`
`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
`
`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
`Facsimile: 903.934.9257
`Of Counsel:
`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.
`
`
`
`
`sf-4454178
`
`

`

`
`
`Case 2:20-cv-00337-JRG Document 84 Filed 04/21/21 Page 10 of 10 PageID #: 2723
`
`CERTIFICATE OF SERVICE
`
`The undersigned hereby certifies that all counsel of record who are deemed to have consented
`
`to electronic service are being served with a copy of the foregoing document via the Court’s CM/ECF
`
`system per Local Rule CV-5(a)(3) this April 16, 2021.
`
`/s/ Travis Underwood
`
`
`
`
`
`CERTIFICATE OF CONFERENCE
`
`
`
`On February 19, 2021, counsel for Seagen, with Michael Jacobs as lead counsel and Andrea
`
`Fair as local counsel, met and conferred via telephone with counsel for DSC, with Preston Ratliff and
`
`Deron Dacus participating. On March 19, 2021, the parties again met and conferred via telephone,
`
`with Michael Jacobs as lead counsel and Andrea Fair and Travis Underwood as local counsel for
`
`Seagen, and Preston Ratliff, Blake Thompson, and Mark Mann for DSC, participating. The parties
`
`were unable to reach agreement and have reached an impasse, leaving an open issue for the Court to
`
`resolve. This motion is opposed by Defendant.
`
`/s/ Michael A. Jacobs
`
`/s/ Travis Underwood
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`sf-4454178
`
`