Case 2:20-cv-00337-JRG Document 98 Filed 05/24/21 Page 1 of 10 PageID #: 2817
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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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`PLAINTIFF SEAGEN INC.’S OPPOSITION TO NON-PARTY THE UNIVERSITY
`OF TEXAS MD ANDERSON CANCER CENTER’S MOTION TO QUASH AND,
`IN THE ALTERNATIVE, MOTION FOR PROTECTIVE ORDER
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`I.
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`INTRODUCTION
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`Plaintiff Seagen Inc.’s (“Seagen”) subpoena to non-party The University of Texas MD
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`Anderson Cancer Center (“MD Anderson”)—now narrowed to just two requests—presents
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`minimal burden to MD Anderson. It is narrowly tailored to seek documents relevant to
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`jurisdiction, venue, and the merits of Seagen’s claim that Daiichi Sankyo Co., Ltd. (“DSC”)
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`infringes U.S. Patent No. 10,808,039 (the “’039 patent”). Because MD Anderson fails to provide
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`specific evidence of the burden it purportedly faces, and Seagen’s narrowing in response to MD
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`Anderson’s objections has minimized any possible burden, MD Anderson’s motion should be
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`denied.
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`II.
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`BACKGROUND
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`The ’039 patent covers an advanced form of a structure known as a “linker” for use in
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`antibody-drug conjugates (ADCs). The linker in an ADC is the portion of the ADC that links the
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`antibody to the drug, and is a critical part of the ADC. Seagen alleges that the linker used in
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`DSC’s Enhertu product infringes the ’039 patent. One location for the clinical testing of Enhertu
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`was at MD Anderson Cancer Center in Houston, Texas. Through publicly available databases of
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`clinical trials for pharmaceuticals, Seagen identified at least three clinical trials of Enhertu that
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`took place at MD Anderson, two of which were sponsored by DSC:
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`• “Study of DS-8201a in Subjects With Advanced Solid Malignant Tumors”
`(NCT02564900, beginning August 2015)
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`• “A Study of DS-8201a in Metastatic Breast Cancer Previously Treated With
`Trastuzumab Emtansine (T-DM1)” (NCT03248492, beginning August 25, 2017)
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`• “DS-8201a in Human Epidermal Growth Factor Receptor2 (HER2)-Expressing
`Colorectal Cancer (DESTINY-CRC01)” (NCT03384940, beginning February 23, 2018)
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`(Declaration of Matthew Chivvis (“Chivvis Decl.”), Exs. D–F.) MD Anderson is likely to have
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`documents related to these studies that took place at its facilities, including information about the
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`study design and results of these clinical trials, as well as communications with DSC scientists
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`during the course of the clinical studies.
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`After serving the subpoena, Seagen conferred with MD Anderson and offered to narrow
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`the requests to alleviate MD Anderson’s concerns of burden. Seagen offered to narrow the
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`subpoena to two discrete requests relating to just the three identified studies. (Chivvis Decl.
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`Exs. B–C.) These two requests seek documents related to the study design and results of three
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`specific studies, and MD Anderson’s communications with DSC scientists regarding the same.
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`(Id.) Seagen is further willing to narrow its request to those studies sponsored by DSC
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`(NCT02564900 and NCT03384940).
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`III. MOTION TO QUASH
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`A. Legal Standard
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`Federal Rule of Civil Procedure 45 explicitly contemplates the use of third-party
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`subpoenas and governs motions to quash. Ass’n of Am. Physicians & Surgeons, Inc. v. Tex. Med.
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`Bd., No. 5:07CV191, 2008 WL 2944671, at *1 (E.D. Tex. July 25, 2008). The party moving to
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`quash “has the burden of proof to demonstrate that compliance with the subpoena would be
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`unreasonable and oppressive.” Wiwa v. Royal Dutch Petroleum Co., 392 F.3d 812, 818 (5th Cir.
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`2004) (quotations omitted). To determine whether the subpoena presents an undue burden,
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`courts “consider the following factors: (1) relevance of the information requested; (2) the need of
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`the party for the documents; (3) the breadth of the document request; (4) the time period covered
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`by the request; (5) the particularity with which the party describes the requested documents; and
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`(6) the burden imposed.” Id. Even if a court finds undue burden, “modification of a subpoena is
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`preferable to quashing it outright.” Id.
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`B. MD Anderson’s Arguments Do Not Justify Quashing the Subpoena
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`Privacy considerations do not prevent MD Anderson from complying with the
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`subpoena. As narrowed, the Subpoena seeks documents related to research agreements and
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`clinical trials regarding Enhertu. MD Anderson does not seriously dispute that the information is
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`relevant, but suggests that privacy concerns, primarily concerning patient information, do not
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`allow it to comply. This is incorrect. The information Seagen is seeking regarding the study
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`design of the two clinical trials was likely created well before MD Anderson collected any
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`protected health information of individual patients. The information Seagen is seeking related to
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`the results of the clinical trials for Enhertu is almost certainly anonymized and aggregated, and it
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`does not implicate the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”).1
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`MD Anderson’s communications with DSC similarly would likely not contain personal
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`confidential information of patients. If a requested document does contain such information, any
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`patient confidential information could be withheld or redacted. Beyond HIPAA-governed
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`information, there are procedural mechanisms that protect against undue disclosure of
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`confidential information, including the protective order in place in this case. (See Dkt. 55.)
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`Instead of invoking these procedural mechanisms, MD Anderson resorts to outright refusal to
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`produce any information.
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`MD Anderson also argues that the requested information “may contain” privileged
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`materials, but does not explain what those materials may be or why any privilege may apply.
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`(Mot. at 2.) If any responsive materials fall under an applicable privilege, MD Anderson may
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`withhold those materials from production. But this does not provide a basis for MD Anderson to
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`withhold non-privileged information that is responsive to the narrowed topics.
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`1 See Dep’t of Health & Human Servs., Research Repositories, Databases, and the HIPAA Privacy Rule 3 (Jan.
`2004), https://privacyruleandresearch.nih.gov/pdf/research_repositories_final.pdf (“The Privacy Rule permits
`covered entities to release data that have been de-identified without obtaining an Authorization and without further
`restrictions upon use or disclosure because de-identified data is not PHI and, therefore, not subject to the Privacy
`Rule.”).
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`The Subpoena is not unduly burdensome. The Subpoena, as narrowed, is tailored to
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`seek information related to just two clinical trials of a single drug—Enhertu—at MD Anderson.
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`(Chivvis Decl. Ex. B.) Seagen’s requests are far narrower than those in American Federation of
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`Musicians, cited by MD Anderson, which sought “all documents concerning the parties to the
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`underlying action, regardless of whether those documents relate to that action and regardless of
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`date; the requests are not particularized; and the period covered by the requests is unlimited.”
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`(Mot. at 3 (citing Am. Fed’n of Musicians of the U.S. and Can. v. Skodam Films, LLC, 313
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`F.R.D. 39, 45 (N.D. Tex. 2015)).) Here, Seagen’s requests are limited to information relating to
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`two clinical trials conducted during clearly-defined time periods. The requests involve a limited
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`universe of MD Anderson personnel, not “over 23,000 employees” as it argues. (Mot. at 4.)
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`MD Anderson further asserts that “the issue at bar is whether this Court has personal
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`jurisdiction over DSC.” (Mot. at 3.) But merits discovery is also open in this case, and has been
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`for almost four months. (See Dkt. 92.) Discovery concerning the research and development of
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`the accused Enhertu product is relevant to infringement and damages, such as the advantages and
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`disadvantages of the accused technology, the importance of the accused technology, and
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`evaluations and reasons decisions were made about treatment decisions and development.
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`Likewise, the extent of DSC’s involvement in research, collaboration, and clinical trials in the
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`United States is relevant to personal jurisdiction.
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`Any subpoena “certainly will impose some burden on and expense” for a third party,
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`“[b]ut that is the natural and expected consequence of being properly served with a Rule 45
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`document subpoena as an entity that clearly has relevant information for a lawsuit to which it is
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`not a party.” Andra Grp., LP v. JDA Software Grp., Inc., 312 F.R.D. 444, 455-56 (N.D. Tex.
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`2015). Seagen has sought to minimize the potential burden and expense to MD Anderson both
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`in the original subpoena and the narrowed requests following conferral. MD Anderson,
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`however, has not provided any evidence of the burden it purportedly faces. See Performance
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`Pulsation Control, Inc. v. Sigma Drilling Techs., LLC, No. 4:17-CV-00450, 2018 WL 5636160,
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`at *2 (E.D. Tex. Oct. 30, 2018) (“The party opposing discovery must show how the requested
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`discovery was overly broad, burdensome, or oppressive by submitting affidavits or offering
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`evidence revealing the nature of the burden.”).
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`The designated place of production is not a burden. Seagen’s subpoena, which seeks
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`the production of documents, does not require any MD Anderson employee to attend a
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`deposition or even to travel to Marshall, Texas to comply with the request. Seagen is willing to
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`accept the documents electronically. Further, The 100 mile limit under Rule 45(c) applies to
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`travel by a subpoenaed person but not a party commanded to produce documents who “need not
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`appear in person at the place of production or inspection . . . .” Fed. R. Civ. P. 45(d)(2)(A); see
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`also Ott v. City of Milwaukee, 274 F.R.D. 238, 242 (E.D. Wis. 2011) (denying motion to quash
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`in part “because [Plaintiff’s] subpoenas are for the production of documents, the State agencies
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`presumably do not have to travel in order to comply with the request.”). In fact, Magistrate
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`Judge Payne has previously stated that “MD Anderson researchers are within this Court’s
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`subpoena power.” Found. Med., Inc. v. Guardant Health, Inc., No. 2:16-CV-00523-JRG-RSP,
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`2017 WL 590297, at *2 (E.D. Tex. Feb. 14, 2017).
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`Seagen provided a reasonable time to comply. MD Anderson’s argument that the
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`subpoena does not provide a reasonable amount of time to comply provides no specifics on why
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`it could not respond within that time frame. (Mot. at 3–4.) Courts have found periods as short as
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`14 days from date of service are “presumptively reasonable in light of the language of Rule
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`45(c)(2)(B).” See In re Rule 45 Subpoena Issued to Cablevision Sys. Corp. Regarding IP
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`Address 69.120.35.31, No. 08-347(ARR)(MDG), 2010 WL 2219343, at *5 (E.D.N.Y. Feb. 5,
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`2010) (collecting cases); see also City of San Antonio v. Hotels.com, L.P., No. SA-06-CA-381-
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`OG, 2008 WL 11334563, at *5 (W.D. Tex. Dec. 30, 2008) (modifying time to comply from 20
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`days to 30 days due to third-party’s estimate of six months needed for review). Seagen’s
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`subpoena provided MD Anderson with 18 days to comply, and Seagen further offered a two-
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`week extension before MD Anderson brought this Motion, resulting in a period of more than 30
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`days. (Chivvis Decl. Ex. A.) And even if the extended time to respond to the subpoena is overly
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`burdensome to MD Anderson, the appropriate relief should be to provide more time, rather than
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`quashing the subpoena. Cf. Wiwa, 392 F.3d at 818 (“Generally, modification of a subpoena is
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`preferable to quashing it outright.”); see also City of San Antonio, 2008 WL 11334563, at *5
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`(modifying time to comply rather than quashing subpoena). Notably, MD Anderson has not said
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`what would be a window it believes is reasonable.
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`MD Anderson has not sufficiently shown that Seagen’s voluntarily-modified requests
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`would create an undue burden such that the subpoena should be quashed.
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`IV. MOTION FOR PROTECTIVE ORDER
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`MD Anderson also has not shown that its alternative request for a protective order against
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`Seagen’s discovery requests is warranted.
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`Under Federal Rule of Civil Procedure 26(c), the Court “may, for good cause, issue an
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`order to protect a party or person from annoyance, embarrassment, oppression, or undue burden
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`or expense.” Fed. R. Civ. P. 26(c)(1). The burden is upon the party seeking the protective order
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`“to show the necessity of its issuance, which contemplates a particular and specific
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`demonstration of fact as distinguished from stereotyped and conclusory statements.” In re:
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`Terra Int’l, Inc., 134 F.3d 302, 306 (5th Cir. 1998) (citations omitted). A protective order is
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`warranted “in those instances in which the party seeking it demonstrates good cause and a
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`specific need for protection.” Sullivan v. Schlumberger Ltd., No. 4:20-CV-00662, 2021 WL
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`858384, at *1 (E.D. Tex. Mar. 8, 2021).
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`MD Anderson has not made such a showing. A protective order in this instance is
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`unnecessary as Seagen has already agreed to narrow its requests to information regarding the
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`study designs, results, and communications with DSC scientists for just two clinical trials. MD
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`Anderson has not demonstrated any specific need for protections as Seagen’s Subpoena does not
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`seek confidential patient health information, and it has demonstrated its willingness to minimize
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`the burden to MD Anderson. It is unclear what additional protection MD Anderson is seeking
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`beyond the protective order already in place in this case. To the extent MD Anderson is seeking
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`a de facto quash of Seagen’s subpoena in the form of a protective order, it should be denied.
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`V.
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`CONCLUSION
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`For the foregoing reasons, the Court should deny MD Anderson’s Motion to Quash and
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`for a Protective Order. This Court should order MD Anderson to comply with Seagen’s
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`subpoena and produce the documents requested therein as narrowed.
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`Dated: May 24, 2021
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`
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`By:
`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
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`Attorneys for Plaintiff Seagen Inc.
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`CERTIFICATE OF SERVICE
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`The undersigned hereby certifies that counsel of record who are deemed to have
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`consented to electronic services are being served with a copy of this document via the Court’s
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`CM/ECF system per Local Rule CV-5(a)(3) on this the 24th day of May, 2021.
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