Case 2:20-cv-00337-JRG Document 318 Filed 02/15/22 Page 1 of 10 PageID #: 11191
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`SEAGEN INC.,
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`v.
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`Plaintiff,
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`CASE NO. 2:20-cv-00337-JRG
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`IN THE UNITED STATES DISTRICT COURT
`EASTERN DISTRICT OF TEXAS
`MARSHALL DIVISION
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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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`DAIICHI SANKYO COMPANY, LIMITED’S
`OPPOSITION TO SEAGEN’S “RENEWED” MOTION FOR SANCTIONS
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`Case 2:20-cv-00337-JRG Document 318 Filed 02/15/22 Page 2 of 10 PageID #: 11192
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`Seagen seeks sanctions for moving to compel Dr. Koji Morita’s deposition, a Daiichi
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`Sankyo Japan employee that did not invent the Accused Product and admittedly had no role in the
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`conjugation process used to make it, and for its pursuit of certain irrelevant lab notebooks that
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`were first revealed by Dr. Morita during his deposition testimony. The
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`patent-in-suit. And as Seagen’s own technical expert admitted, the l
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` of her prior analysis because they simply reflect the same experiments featured as
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`examples in Daiichi Sankyo Japan’s publicly-available patents that she previously reviewed.
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`In support of its “renewed” motion for sanctions, Seagen weaves a false narrative by
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`misrepresenting the lab notebooks as some sort of “smoking gun” evidence that Daiichi Sankyo
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`Japan allegedly withheld from discovery (it did not) to deflect from the obvious fact that Seagen’s
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`pursuit of discovery concerning conjugation methods was designed to support its tactic of
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`reopening the Arbitration between Seagen and Daiichi Sankyo Japan. While the Arbitration
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`involves Seagen’s meritless allegation that Daiichi Sankyo Japan utilized a Seagen-proprietary
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`, that allegation is completely irrelevant to this action where Seagen’s patent
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`does not claim or even disclose any
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`. The reality is Daiichi Sankyo Japan has
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`at all times acted in good faith, promptly searched for and voluntarily produced the lab notebooks
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`despite their complete lack of relevance, and any conceivable prejudice to Seagen has been cured.
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`Simply put, there are no manifest bad faith or bad acts by Daiichi Sankyo Japan to warrant any
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`sanctions. Seagen’s motion should be denied.
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`I.
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`RELEVANT BACKGROUND
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`The patent-in-suit claims certain chemical compositions known as antibody-drug
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`conjugates (“ADCs”) by their chemical structure. It does not claim any ADC conjugation or
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`manufacturing process; Seagen does not—and cannot—dispute that the process for making the
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`Case 2:20-cv-00337-JRG Document 318 Filed 02/15/22 Page 3 of 10 PageID #: 11193
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`ADCs is not claimed and therefore has no bearing on infringement. Daiichi Sankyo Japan
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`produced complete discovery regarding the chemical structure and design of the antibody, linker,
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`and drug payload of the Accused Product, including its entire biologics license application
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`(“BLA”) to the FDA, which defines every important detail for the drug product that may be sold
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`in the United States. Despite the lack of any manufacturing process claims in the patent-in-suit,
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`Daiichi Sankyo Japan thus produced the authoritative documents reflecting the manufacturing
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`process for the Accused Product. (See Dkt. 197; Dkt. 239 at 6-7.)
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`Seagen seeks sanctions principally in connection with discovery regarding Daiichi Sankyo
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`Japan scientist Dr. Morita. The Accused Product was solely conceived of and invented by Dr.
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`Hiroyuki Naito, not Dr. Morita, an indisputable fact that repeatedly has been confirmed by Daiichi
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`Sankyo Japan’s witnesses, including Dr. Morita himself.1 (See, e.g., Ex. 1 (Morita Tr.) at 16:5-
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`11.) Moreover, despite Seagen’s continued focus on him,
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`24.)
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`Seagen’s motion is styled as a “renewed” motion, but it is not “renewed” at all. It is an
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`attempt to further distort the facts and seek relief Seagen never previously requested and is not
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`entitled to obtain. Were this truly a renewed motion, it would seek only fees and costs (which are
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`not recoverable here (see Dkt. 239 at 6-7)), the only relief sought in the prior motion that Seagen
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`has not obtained already. (See Dkt. 234 at 7.) Instead, Seagen without merit now seeks different
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`sanctions to obscure the reality that the alleged withheld documents fail to support any assertion
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`of wrongdoing by Daiichi Sankyo Japan, much less wrongdoing pertinent to the patent-in-suit’s
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`claims: a jury instruction that Daiichi Sankyo Japan “withheld evidence on the use of Seagen
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`1 To the extent that Drs. Morita and Miyazaki appear as inventors on Daiichi Sankyo Japan’s patents, those patents
`disclose and cover subject matter beyond the Accused Product.
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`Case 2:20-cv-00337-JRG Document 318 Filed 02/15/22 Page 4 of 10 PageID #: 11194
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`information in the development of the accused product,” and testimony to the Court to explain
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`Daiichi Sankyo Japan’s “search and review process for relevant documents responsive to Seagen’s
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`requests, including when [Daiichi Sankyo Japan] first became aware of the notebooks and whether
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`[Daiichi Sankyo Japan] has now produced all relevant documents reflecting reference to or use of
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`Seagen technology in its ADC linker development” that is wasteful at best and severely prejudicial
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`at worst. (Mot. 7 (emphasis added).)2 Seagen thus seeks to introduce instructions and evidence
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`regarding Daiichi Sankyo Japan’s process of searching for documents that undisputedly have been
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`produced here, which is improper, prejudicial, and confusing to the jury; this trial is about
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`Seagen’s patent, not document collection.
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`II.
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`ARGUMENT
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`A.
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`Daiichi Sankyo Japan Acted in Good Faith and Timely Produced the
`Lab Notebooks That Have No Bearing On Seagen’s Infringement Claim
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` (see infra). Despite the lack of relevance, Daiichi Sankyo Japan
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`promptly proceeded to collect and produce the lab notebooks, as well as seven other irrelevant lab
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`notebooks requested by Seagen that Dr. Morita did not even identify during his deposition.
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`Seagen’s motion fails to explain—because it cannot—how
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` have any relevance to Seagen’s patent
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`infringement claim. Instead, Seagen plays fast and loose in describing the patented subject matter
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`and characterizing Seagen-confidential information to create the appearance that the lab notebooks
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`2 Seagen notably does not define “Seagen information” or “Seagen technology,” which illustrates Seagen’s efforts to
`obscure the nature of the content of the lab notebooks, which is irrelevant to Seagen’s claim in this lawsuit. Seagen’s
`request lacks specificity and is loaded with incorrect and unsupported conclusions about the nature of the material,
`which underscores the impropriety of the instruction and testimony Seagen now seeks.
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`Case 2:20-cv-00337-JRG Document 318 Filed 02/15/22 Page 5 of 10 PageID #: 11195
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`are some “smoking gun” when in truth they are irrelevant here.
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`This patent action involves only compound claims, not method claims, meaning that the
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`sole issue of the infringement inquiry is the structure and design of the Accused Product (the entire
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`structure of which is, and is required to be, disclosed in Daiichi Sankyo Japan’s BLA filing with
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`the FDA). That disposes of Seagen’s claim of relevance, as “the process by which a product is
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`made is irrelevant to the question of whether that product infringes a pure apparatus claim.”
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`Baldwin Graphic Sys., Inc. v. Siebert, Inc., 512 F.3d 1338, 1344 (Fed. Cir. 2008).3
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`Also, Seagen has argued, and moved to compel arbitration on the grounds, that
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`Mem. Order, Daiichi Sankyo Company, Ltd. v. Seattle Genetics, Inc., C.A. No. 19-2087-LPS, Dkt.
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`.4 See
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`41 (D. Del. Oct. 27, 2020). Further, the
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`. (See Ex. 1 (Morita Tr.) at 26:4-24, 33:1-6; Ex. 2.) See Arthrex, Inc. v. Smith &
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`Nephew, Inc., 2016 WL 11750180, at *4 (E.D. Tex. Nov. 30, 2016) (precluding evidence of non-
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`patented feature copying to show willful infringement); Am. Tech. Ceramics Corp. v. Presidio
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`Components, Inc., No. 14-CV-6544(KAM)(GRB), 2019 WL 2330855, at *10 (E.D.N.Y. May 31,
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`2019).5
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`Nevertheless, Seagen repeatedly alleges that Daiichi Sankyo Japan misled Seagen and this
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`Court with respect to its representation of discovery compliance, including through making a
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`3 Seagen’s attempt to tie the lab notebooks to the claims by pointing to the requirement to conjugate to an antibody’s
`cysteine residue fails, as such technology was known for decades before Seagen filed its claims. Seagen’s own
`witnesses readily agreed this idea was not Seagen’s and instead was published long before Seagen even existed. (See
`Ex. 1 (Senter Tr.) at 489:9-19; Ex. 1 (Jeffrey Tr.) at 54:14-21.)
`4 Of course, the separate arbitration is precisely why Seagen has sought such broad discovery unrelated to its
`infringement claim here; Seagen is misusing this lawsuit and this Court’s processes to obtain discovery unrelated to
`this suit for Seagen to use in a separate proceeding.
`5 The cases Seagen cites on this point are inapposite given that the subject matter of the lab notebooks is irrelevant to
`Seagen’s claim and to the subject matter of the patent-in-suit.
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`Case 2:20-cv-00337-JRG Document 318 Filed 02/15/22 Page 6 of 10 PageID #: 11196
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`purportedly false certification. That is incorrect. All representations, including the certification
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`that Seagen raises, were and continue to be true and accurate.
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`Seagen’s revised requests (see Dkt. 92) were directed to the Accused Product, i.e.,
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`ENHERTU®, the commercial product version of DS-8201.
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`t. (Ex. 2 (Morita Tr.) at 26:4-24,
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`33:1-6; Ex. 2.)
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` (See Ex. 2.) In addition,
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` (See Ex. 1 (Morita Tr.) at 26:4-24, 28:21-24, 29:12-17.)
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` (See Mot. 3, Ex. A.)
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`. (See Dkt. 197 at 4, Ex. 1 (Row C).) Further,
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`The notion that Daiichi Sankyo Japan should be sanctioned for producing these materials
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`in good faith is untenable. See Packless Metal Hose, Inc. v. Extek Energy Equipment (Zhejiang)
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`Co., No. 2:09-CV-265-JRG, 2013 WL 12147764, at *1 (E.D. Tex. Mar. 25, 2013) (“[I]n light of
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`Packless’s failure to offer proof of bad faith, the Court must decline to impose sanctions.”).
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`B.
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`Seagen Has Not Suffered Prejudice,
`But Any Possible Prejudice Has Been Cured
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`Seagen likewise cannot show the requisite prejudice to impose sanctions. Assuming,
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`Case 2:20-cv-00337-JRG Document 318 Filed 02/15/22 Page 7 of 10 PageID #: 11197
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`arguendo, that the conjugation parameters in the lab notebooks were relevant to this action,
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`although they are not, they would at most amount to duplicative evidence which does not support
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`a finding that Seagen has been prejudiced. Even Seagen’s technical expert, Dr. Bertozzi,
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`acknowledges this,
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` match those disclosed in Daiichi Sankyo Japan’s patents.6 (See Ex. 3.) That long-
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`publicly available patent was also produced to Seagen well before the close of fact discovery.
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`Tellingly, the lab notebooks did not change Dr. Bertozzi’s analysis or conclusions; she even
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`described the notebooks as
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`Additionally, Seagen cannot credibly claim that it has been prejudiced to warrant sanctions.
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`The lab notebooks were produced 19 days after Dr. Morita revealed them and Seagen requested
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`them (as well as other notebooks). Further, Seagen had no difficulty serving a supplemental expert
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`report on the lab notebooks, and Dr. Morita promptly sat for another deposition voluntarily.
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`Seagen has obtained all that it sought; it suffered no prejudice and its motion thus should be denied.
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`C.
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`The Lab Notebooks Are Not Evidence of Copying
`and Seagen’s Requested Sanctions are Inappropriate
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`. Not so, and Seagen’s
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`accusation is based on selective quotation of Dr. Morita’s deposition. Seagen omits key testimony:
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`.7 In fact, the cysteine conjugation referenced was practiced by Daiichi Sankyo Japan
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`6 Dr. Morita confirmed this as well during his January 2022 deposition. (See Ex. 1 (Morita Tr.) at 284:16-286:13.)
`7 Generic cysteine conjugation method using an MC group is not and has never been proprietary to Seagen. To date,
`Seagen’s witnesses have repeatedly admitted this fact.
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`Case 2:20-cv-00337-JRG Document 318 Filed 02/15/22 Page 8 of 10 PageID #: 11198
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`scientists well before the collaboration work with Seagen. Thus,
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` That allegation is also false.
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`. (See id.)
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` (See Ex. 1 (Morita Tr.) at 230:21-231:15; see also Ex. 2.)
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`In sum, the lab notebooks do not evidence any copying. Seagen’s motion completely fails
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`to identify what of Seagen’s was supposedly copied, how it is supposedly Seagen-confidential,
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`and ignores that the patent-in-suit fails to claim any conjugation process;
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` To permit Seagen to present or instruct the jury based on these materials
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`that Daiichi Sankyo Japan supposedly “copied,” when the materials do not relate to subject matter
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`covered by the patent-in-suit and do not actually show any copying, would be unfairly and unduly
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`prejudicial to Daiichi Sankyo Japan. See United States v. Dvorin, 817 F.3d 438, 453 (5th Cir.
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`2016) (“Any sanction imposed should be the least severe penalty necessary to ensure compliance
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`with the court’s discovery orders.”). Seagen’s motion should be denied.8
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`8 Seagen’s additional allegations of misconduct during Dr. Morita’s January 10, 2022 deposition (which again required
`him to endure the burdens of travel from Japan) are without merit. Seagen was not entitled to probe privileged
`communications between attorney and client, so Daiichi Sankyo Japan’s counsel’s objections and instructions not to
`answer based on privilege were appropriate (Seagen’s references to the “sword and shield” doctrine are entirely
`misplaced and legally unfounded in this context). Additionally, the deposition was limited to the narrow subject of
`the contents of the lab notebooks, so it was appropriate for counsel to disallow testimony beyond that scope. If Seagen
`had a legitimate concern, it could have utilized the Court’s discovery hotline, yet it did not do so.
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`Case 2:20-cv-00337-JRG Document 318 Filed 02/15/22 Page 9 of 10 PageID #: 11199
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`Dated: February 4, 2022
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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
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`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 318 Filed 02/15/22 Page 10 of 10 PageID #: 11200
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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 February
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`4, 2022.
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`/s/ Preston K. Ratliff II
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