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`CASE NO. 2:20-cv-00337-JRG
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`JURY TRIAL DEMANDED
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`SEAGEN INC.,
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`Plaintiff,
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`v.
`DAIICHI SANKYO CO., LTD.,
`Defendant.
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`DEFENDANT DAIICHI SANKYO COMPANY,
`LIMITED’S ANSWER TO PLAINTIFF’S COMPLAINT
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`Case 2:20-cv-00337-JRG Document 118 Filed 07/12/21 Page 1 of 9 PageID #: 4492
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`IN THE UNITED STATES DISTRICT COURT
`EASTERN DISTRICT OF TEXAS
`MARSHALL DIVISION
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`Defendant Daiichi Sankyo Company, Limited (“Daiichi Sankyo Japan”), by and through
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`undersigned counsel, answers the Complaint1 of Plaintiff Seagen Inc. (“Seagen”) as follows:
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`1.
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`2.
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`Daiichi Sankyo Japan denies each and every allegation in Paragraph 1.
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`Daiichi Sankyo Japan admits that Seagen attempts to describe antibody-drug
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`conjugates, but Seagen’s description is very general, incomplete, and misleading. Daiichi Sankyo
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`Japan further admits that Seagen attempts to allege that as of the date of Seagen’s Complaint that
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`only nine antibody-drug conjugates have been approved by the FDA. However, it is not clear to
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`which type of FDA approval Seagen’s Complaint refers, so Daiichi Sankyo Japan denies this
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`allegation. Except as admitted, Daiichi Sankyo Japan denies each and every allegation in
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`Paragraph 2.
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`1 Daiichi Sankyo Japan does not believe that this heading or any of the headings in Seagen’s
`Complaint require a response. If a response is required, Daiichi Sankyo Japan denies each and
`any allegations, express or implied, in such headings.
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`- 1 -
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`Case 2:20-cv-00337-JRG Document 118 Filed 07/12/21 Page 2 of 9 PageID #: 4493
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`3.
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`Daiichi Sankyo Japan admits that Seagen received a FDA approval in 2011 for the
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`antibody-drug conjugate known as Adcetris®. Except as admitted, Daiichi Sankyo Japan denies
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`each and every allegation in Paragraph 3.
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`4.
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`5.
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`Daiichi Sankyo Japan denies each and every allegation in Paragraph 4.
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`Daiichi Sankyo Japan lacks knowledge or information sufficient to form a belief as
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`to the truth of what Seagen intends by its Complaint and denies that allegation on that basis.
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`Daiichi Sankyo Japan denies each and every remaining allegation in Paragraph 5.
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`THE PARTIES
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`6.
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`Daiichi Sankyo Japan admits that Seagen is a biotechnology company formerly
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`known as Seattle Genetics, Inc. On information and belief, Daiichi Sankyo Japan further admits
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`that Seagen is headquartered in Bothell, Washington, and is incorporated under the laws of
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`Delaware. Except as admitted, Daiichi Sankyo Japan denies each and every allegation in
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`Paragraph 6.
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`7.
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`Daiichi Sankyo Japan admits that Daiichi Sankyo Company, Limited is a Japanese
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`corporation with its principal place of business at 3-5-1, Nihonbashi, Honchō, Chūo-ku, Tokyo
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`103-8426, Japan.
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`JURISDICTION AND VENUE
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`8.
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`9.
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`Daiichi Sankyo Japan denies each and every allegation in Paragraph 8.
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`Daiichi Sankyo Japan denies each and every allegation in Paragraph 9.
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`10.
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`Daiichi Sankyo Japan owns the registration for the Enhertu® trademark for DS-
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`8201. Daiichi Sankyo Japan denies each and every remaining allegation in Paragraph 10.
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`11.
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`12.
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`Daiichi Sankyo Japan denies each and every allegation in Paragraph 11.
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`Daiichi Sankyo Japan denies each and every allegation in Paragraph 12.
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`- 2 -
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`Case 2:20-cv-00337-JRG Document 118 Filed 07/12/21 Page 3 of 9 PageID #: 4494
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`13.
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`Daiichi Sankyo Japan denies each and every allegation in Paragraph 13.
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`PATENT-IN-SUIT – U.S. PATENT NO. 10,808,039
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`14.
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`Daiichi Sankyo Japan lacks knowledge or information sufficient to form a belief as
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`to the truth of Seagen’s alleged ownership of U.S. Patent No. 10,808,039 (“the ’039 patent” or
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`“the patent-in-suit”) and whether Seagen has the sole right to enforce it, and denies that allegation
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`on that basis. Daiichi Sankyo Japan denies each and every remaining allegation in Paragraph 14.
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`15.
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`Daiichi Sankyo Japan admits that Seagen attempts to state what the ’039 patent
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`claims as well as a purported history of antibody-drug conjugate technology. Seagen’s allegations,
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`however, are incomplete, misleading, and unclear. Except as admitted, Daiichi Sankyo Japan
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`denies each and every allegation in Paragraph 15.
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`16.
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`Daiichi Sankyo Japan denies each and every allegation in Paragraph 16.
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`ALLEGED INFRINGEMENT
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`17.
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`18.
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`19.
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`20.
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`Daiichi Sankyo Japan denies each and every allegation in Paragraph 17.
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`Daiichi Sankyo Japan denies each and every allegation in Paragraph 18.
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`Daiichi Sankyo Japan denies each and every allegation in Paragraph 19.
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`Daiichi Sankyo Japan denies each and every allegation in Paragraph 20.
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`COUNT I
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`21.
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`Daiichi Sankyo Japan repeats and realleges its answers and denials to the preceding
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`Paragraphs as if fully set forth here.
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`22.
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`23.
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`24.
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`25.
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`Daiichi Sankyo Japan denies each and every allegation in Paragraph 22.
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`Daiichi Sankyo Japan denies each and every allegation in Paragraph 23.
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`Daiichi Sankyo Japan denies each and every allegation in Paragraph 24.
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`Daiichi Sankyo Japan denies each and every allegation in Paragraph 25.
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`- 3 -
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`Case 2:20-cv-00337-JRG Document 118 Filed 07/12/21 Page 4 of 9 PageID #: 4495
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`26.
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`27.
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`28.
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`29.
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`Daiichi Sankyo Japan denies each and every allegation in Paragraph 26.
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`Daiichi Sankyo Japan denies each and every allegation in Paragraph 27.
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`Daiichi Sankyo Japan denies each and every allegation in Paragraph 28.
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`Daiichi Sankyo Japan denies each and every allegation in Paragraph 29.
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`PRAYER FOR RELIEF
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`30.
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`Daiichi Sankyo Japan denies that Seagen is entitled to any relief from Daiichi
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`Sankyo Japan or the Court, either as prayed for in the Complaint or otherwise. Daiichi Sankyo
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`Japan has not infringed, either directly or indirectly, any valid and enforceable claim of the patent-
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`in-suit, and Seagen is not entitled to any remedy or recovery. To the extent paragraphs A-F under
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`Plaintiff’s Prayer for Relief are interpreted to contain any factual allegations, Daiichi Sankyo Japan
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`denies them.
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`DEFENSES
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`Daiichi Sankyo Japan asserts the following defenses. In doing so, Daiichi Sankyo Japan
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`does not assume the burden of proof for matters for which Seagen bears the burden. Daiichi
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`Sankyo Japan also reserves all rights to allege additional defenses that become known during the
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`litigation.
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`First Defense
`(Non-Infringement)
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`Daiichi Sankyo Japan does not infringe, and has not infringed (directly, indirectly, literally
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`or under the doctrine of equivalents) any valid and enforceable claim of the ’039 patent.
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`- 4 -
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`Case 2:20-cv-00337-JRG Document 118 Filed 07/12/21 Page 5 of 9 PageID #: 4496
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`Second Defense
`(Invalidity)
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`The claims of the ’039 patent are invalid and/or unenforceable for failure to satisfy one or
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`more of the patentability conditions set forth in Title 35 of the U.S. Code, including but not limited
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`to 35 U.S.C. §§ 102 and 112.
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`Third Defense
`(Prosecution Laches)
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`
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`The claims of the ’039 patent are unenforceable and Seagen’s claims for relief are barred
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`by the equitable doctrine of prosecution laches due to Seagen’s unreasonable and unexplained
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`delay in the prosecution of the patent application resulting in the ’039 patent.
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`Fourth Defense
`(Estoppel, Waiver, and Unclean Hands)
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`Seagen’s claims for relief are barred, in whole or in part, by the equitable doctrines of
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`estoppel, waiver and/or unclean hands.
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`Fifth Defense
`(Prosecution History Estoppel)
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`Seagen’s infringement claims are barred by the doctrine of prosecution history estoppel
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`based on statements, representations, and admissions made during the prosecution of the patent
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`application resulting in the ’039 patent.
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`Sixth Defense
`(No Exceptional Case)
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`Seagen pleaded no valid basis for finding an exceptional case under 35 U.S.C. § 285.
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`Seventh Defense
`(Limitation of Damages)
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`Seagen’s claims for damages, costs, or attorneys’ fee, if any, against Daiichi Sankyo Japan
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`for alleged patent infringement is limited by 35 U.S.C. §§ 286 and/or 288.
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`- 5 -
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`Case 2:20-cv-00337-JRG Document 118 Filed 07/12/21 Page 6 of 9 PageID #: 4497
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`Eighth Defense
`(Safe Harbor)
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`Daiichi Sankyo Japan’s alleged activities with regard to Daiichi Sankyo Japan’s “pipeline
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`products” that Seagen mentions in its Complaint—U3-1402, DS-1062, DS-7300, and DS-6157,
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`do not constitute infringement as a matter of law under 35 U.S.C. § 271(e)(1).
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`RESERVATION OF RIGHTS
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`Defendant reserves the right to assert any additional defenses, as they become known
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`during the course of this action, or to the extent they are not otherwise deemed affirmative defenses
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`by law.
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`PRAYER FOR RELIEF
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`WHEREFORE, Daiichi Sankyo Japan prays for judgment that:
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`A.
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`Seagen’s Complaint against Daiichi Sankyo Japan be dismissed in its entirety with
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`prejudice;
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`B.
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`Seagen is not entitled to any relief prayed for in its Complaint against Daiichi
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`Sankyo Japan, or to any relief whatsoever;
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`C.
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`Daiichi Sankyo Japan has not infringed any valid and enforceable asserted claim of
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`the ’039 patent;
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`D.
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`E.
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`Each asserted claim of the ’039 patent is invalid and unenforceable;
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`The claims of the ’039 patent are unenforceable due to the equitable doctrine of
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`prosecution laches;
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`F.
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`No damages or royalties are due or owing for any of the acts alleged by Seagen in
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`its Complaint as to Daiichi Sankyo Japan;
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`G.
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`Daiichi Sankyo Japan be awarded its costs, disbursements, and reasonable
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`attorneys’ fees pursuant to 35 U.S.C. § 285 as against Seagen; and
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`- 6 -
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`Case 2:20-cv-00337-JRG Document 118 Filed 07/12/21 Page 7 of 9 PageID #: 4498
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`H.
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`Daiichi Sankyo Japan be granted such other and further relief as the Court may
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`deem just and proper.
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`JURY DEMAND
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`Daiichi Sankyo Japan demands a trial by jury of all issues triable in this action.
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`- 7 -
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`Case 2:20-cv-00337-JRG Document 118 Filed 07/12/21 Page 8 of 9 PageID #: 4499
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`Dated: July 12, 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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`Attorneys for Defendant Daiichi
`Sankyo Company, Limited
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`- 8 -
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`Case 2:20-cv-00337-JRG Document 118 Filed 07/12/21 Page 9 of 9 PageID #: 4500
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`CERTIFICATE OF SERVICE
`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 July 12,
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`2021.
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` /s/ Preston K. Ratliff II
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