Case 1:20-cv-01524-LPS Document 1 Filed 11/13/20 Page 1 of 10 PageID #: 1
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
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`DAIICHI SANKYO, INC., DAIICHI SANKYO
`COMPANY, LIMITED, and ASTRAZENECA
`PHARMACEUTICALS LP,
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`v.
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`SEAGEN INC.,
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`C. A. No. ______________
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`JURY TRIAL DEMANDED
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`Plaintiffs,
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`Defendant.
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`COMPLAINT FOR DECLARATORY JUDGMENT OF NON-INFRINGEMENT
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`Plaintiffs Daiichi Sankyo, Inc., Daiichi Sankyo Company, Limited, and AstraZeneca
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`Pharmaceuticals LP (collectively, “Plaintiffs”) by their attorneys, for their Complaint against
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`Defendant Seagen Inc., f/k/a Seattle Genetics, Inc., allege as follows:
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`I.
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`THE PARTIES
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`1.
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`Daiichi Sankyo, Inc. (“DSI”) is a corporation organized and existing under the laws
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`of the State of Delaware, with its principal place of business in Basking Ridge, New Jersey. DSI is
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`in the business of creating, developing, and bringing to market revolutionary biopharmaceutical
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`products to treat serious diseases, including cancer.
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`2.
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`Daiichi Sankyo Company, Limited (“DSC”) is a corporation organized and existing
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`under the laws of Japan, having a principal place of business in Tokyo, Japan. DSC is in the
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`business of creating, developing, and bringing to market revolutionary biopharmaceutical products
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`to treat serious diseases, including cancer.
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`3.
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`AstraZeneca Pharmaceuticals LP (“AstraZeneca”) is a limited partnership organized
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`and existing under the laws of the State of Delaware, with its corporate headquarters in
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`{01627741;v1 }
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`
`
`DAIICHI SANKYO, INC., DAIICHI SANKYO
`COMPANY, LIMITED, and ASTRAZENECA
`PHARMACEUTICALS LP,
`
`
`
`v.
`
`SEAGEN INC.,
`
`
`
`
`
`
`
`
`
`
`
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`C. A. No. ______________
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`JURY TRIAL DEMANDED
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`
`
`
` )
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`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`
`Plaintiffs,
`
`Defendant.
`
`COMPLAINT FOR DECLARATORY JUDGMENT OF NON-INFRINGEMENT
`
`Plaintiffs Daiichi Sankyo, Inc., Daiichi Sankyo Company, Limited, and AstraZeneca
`
`Pharmaceuticals LP (collectively, “Plaintiffs”) by their attorneys, for their Complaint against
`
`Defendant Seagen Inc., f/k/a Seattle Genetics, Inc., allege as follows:
`
`I.
`
`THE PARTIES
`
`1.
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`Daiichi Sankyo, Inc. (“DSI”) is a corporation organized and existing under the laws
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`of the State of Delaware, with its principal place of business in Basking Ridge, New Jersey. DSI is
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`in the business of creating, developing, and bringing to market revolutionary biopharmaceutical
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`products to treat serious diseases, including cancer.
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`2.
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`Daiichi Sankyo Company, Limited (“DSC”) is a corporation organized and existing
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`under the laws of Japan, having a principal place of business in Tokyo, Japan. DSC is in the
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`business of creating, developing, and bringing to market revolutionary biopharmaceutical products
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`to treat serious diseases, including cancer.
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`3.
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`AstraZeneca Pharmaceuticals LP (“AstraZeneca”) is a limited partnership organized
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`and existing under the laws of the State of Delaware, with its corporate headquarters in
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`{01627741;v1 }
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`Case 1:20-cv-01524-LPS Document 1 Filed 11/13/20 Page 2 of 10 PageID #: 2
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`Wilmington, Delaware. AstraZeneca is in the business of creating, developing, and bringing to
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`market revolutionary biopharmaceutical products to treat serious diseases, including cancer.
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`4.
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`On information and belief, Seagen Inc. (“SGI”) is a corporation organized and
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`existing under the laws of Delaware, with its principal place of business in Bothell, Washington.
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`II.
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`NATURE OF THE ACTION
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`5.
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`This is a civil action for declaratory relief pursuant to Federal Rule of Civil
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`Procedure 57, the patent laws of the United States, including Title 35, United States Code, and the
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`Declaratory Judgment Act, 28 U.S.C. § 2201. DSI, DSC, and AstraZeneca seek a declaration that
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`the importation into the United States, manufacture, use, offer for sale, or sale of ENHERTU®, an
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`FDA-approved pharmaceutical for the treatment of adult patients suffering from certain breast
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`cancers, does not infringe United States Patent No. 10,808,039 (“the ’039 patent”) and that
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`Plaintiffs do not induce infringement of, or contribute to the infringement of, the ’039 patent.
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`6.
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`This action arises out of SGI’s allegations that ENHERTU® infringes the
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`’039 patent.
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`7.
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`A related action between SGI and Plaintiff DSC concerning intellectual property
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`rights relating to ENHERTU® was previously filed by DSC and is pending in this Court.1 In
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`addition, SGI’s claim to intellectual property rights relating to ENHERTU® is subject to an
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`arbitration initiated by SGI against DSC.2
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`1 C.A. No. 19-2087-LPS (filed Nov. 4, 2019).
`2 AAA Case Number 01-19-0004-0115.
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`Case 1:20-cv-01524-LPS Document 1 Filed 11/13/20 Page 3 of 10 PageID #: 3
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`
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`III.
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`JURISDICTION AND VENUE
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`A.
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`8.
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`Subject-Matter Jurisdiction
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`This Court has jurisdiction over the subject matter of this action pursuant to
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`28 U.S.C. §§ 1331, 1338(a), and 2201.
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`9.
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`As described in more detail below, an immediate, real, and justiciable controversy
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`exists between Plaintiffs and SGI as to whether Plaintiffs are infringing or have infringed the ’039
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`patent.
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`B.
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`10.
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`Personal Jurisdiction
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`This Court has general personal jurisdiction over SGI because SGI is a Delaware
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`corporation and thus resides at and is at home in the District of Delaware. Further, on information
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`and belief, SGI has availed itself of the rights and benefits of Delaware law, and has engaged in
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`systematic and continuous contacts with the State of Delaware.
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`C.
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`11.
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`Venue
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`Venue is proper in this District under 28 U.S.C. §§ 1391(b) and (c).
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`IV.
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`BACKGROUND
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`A.
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`12.
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`ENHERTU®
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`ENHERTU® is a type of biologic product known in the pharmaceutical industry as
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`an antibody-drug conjugate (“ADC”). ENHERTU® is commonly referred to by other names,
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`including DS-8201, fam-trastuzumab deruxtecan, and fam-trastuzumab deruxtecan-nxki.
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`13.
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`ENHERTU® was approved by the United States Food and Drug Administration
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`(“FDA”) on an accelerated basis on December 20, 2019 for the treatment of unresectable or
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`metastatic HER2-positive breast cancer in patients who have received two or more prior
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`anti-HER2-based regimens in the metastatic setting. DSI submitted a Biologics License
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`Case 1:20-cv-01524-LPS Document 1 Filed 11/13/20 Page 4 of 10 PageID #: 4
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`Application pursuant to which the FDA granted ENHERTU®’s accelerated approval, thus
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`becoming the only company licensed by the FDA to introduce or deliver for introduction into
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`interstate commerce ENHERTU®. Consistent with this regulatory approval, of the Plaintiffs,
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`ENHERTU® is offered for sale and sold in the United States only by DSI.
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`14.
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`Plaintiff DSC manufactures ENHERTU®. ENHERTU® is not manufactured in the
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`United States.
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`15.
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`DSI purchases bulk vials of ENHERTU® from DSC and sells packaged
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`ENHERTU® only to a select network of specialty distributors and pharmacies, who in turn sell
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`ENHERTU® to customers in the United States.
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`16.
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`ENHERTU® is marketed in the United States collaboratively by Plaintiffs DSI and
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`AstraZeneca. Both DSI and AstraZeneca employ sales representatives who build awareness of
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`ENHERTU® in the medical community. Both DSI and AstraZeneca publish resources to inform
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`patients about taking ENHERTU®, for example, the ENHERTU 4U website.3 Both DSI and
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`AstraZeneca employ medical science liaisons who educate the medical community about
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`ENHERTU®.
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`B.
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`17.
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`The ’039 Patent
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`On information and belief, on October 20, 2020, the ’039 patent entitled
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`“Monomethylvaline Compounds Capable of Conjugation to Ligands” issued to Svetlana O.
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`Doronina, Peter D. Senter, Brian E. Toki, and Toni Beth Kline. Based upon allegations made by
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`Defendant SGI in a complaint filed in the United States District Court for the Eastern District of
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`3 https://www.enhertu4u.com/patient.html
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`Case 1:20-cv-01524-LPS Document 1 Filed 11/13/20 Page 5 of 10 PageID #: 5
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`Texas, SGI is the sole owner of the ’039 patent and holds the sole right to seek enforcement of that
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`patent.4 A true and correct copy of the ’039 patent is attached to this Complaint as Exhibit A.
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`18.
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`The ’039 patent claims, among other things, certain ADCs, having the formula:
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`or a pharmaceutically acceptable salt thereof, wherein:
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`Ab is an antibody, S is sulfur, each -Ww- unit is a tetrapeptide; wherein each -W- unit is
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`independently an Amino Acid unit having the formula denoted below in the square bracket:
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`wherein R19 is hydrogen or benzyl, Y is a Spacer unit, y is 0, 1, or 2, D is a drug moiety,
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`and p ranges from 1 to about 20, wherein the S is a sulfur atom on a cysteine residue of the
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`antibody, and wherein the drug moiety is intracellularly cleaved in a patient from the antibody of
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`the antibody-drug conjugate or an intracellular metabolite of the antibody-drug conjugate.
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`4 Case 2:20-cv-00337 (E.D. Tex.), D.I. 1 ¶ 14 (“Texas Complaint”).
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`Case 1:20-cv-01524-LPS Document 1 Filed 11/13/20 Page 6 of 10 PageID #: 6
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`19.
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`ENHERTU®, on the other hand, is depicted in the figure below.
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`This figure is one way to illustrate the chemical structure of ENHERTU®. For simplicity,
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`the figure does not show the chemical structure of the antibody in ENHERTU®, which is
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`trastuzumab, and does not show that approximately eight molecules of drug are attached to each
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`antibody molecule. S in the figure is a sulfur atom at a cysteine residue of the antibody.
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`20.
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`ENHERTU® is a HER2-directed ADC. ENHERTU® is composed of trastuzumab
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`(an anti-HER2 antibody) attached to a topoisomerase I inhibitor compound through a cleavable
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`linker. Following binding to HER2 on tumor cells, ENHERTU® undergoes internalization and
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`intracellular linker cleavage by lysosomal enzymes, releasing a membrane-permeable
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`topoisomerase I inhibitor compound known today as DXd, which causes DNA damage and
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`apoptotic cell death. Approximately, eight molecules of drug are attached to each antibody
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`molecule.
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`C.
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`21.
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`SGI’s Allegation that ENHERTU® Infringes the ’039 Patent
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`SGI has asserted the ʼ039 patent in the United States District Court for the Eastern
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`District of Texas against Plaintiff DSC. In that action, SGI does not name either of Plaintiff DSI or
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`Plaintiff AstraZeneca as a party.
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`Case 1:20-cv-01524-LPS Document 1 Filed 11/13/20 Page 7 of 10 PageID #: 7
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`22.
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`SGI’s Texas Complaint alleges, among other things, that DSC’s “subsidiaries and
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`contractual business partners have operated as agents of DSC . . . Through these agents, DSC has
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`conducted business and committed acts of infringement in the United States, Texas, and this
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`district.” Texas Complaint ¶ 11. The conduct accused of infringement in SGI’s Texas Complaint
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`is described at paragraphs 17–20 and the product charted by SGI for purposes of alleging
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`infringement is DS-8201, i.e., ENHERTU®.
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`23.
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`SGI’s infringement allegations extend beyond ENHERTU®. SGI alleges that
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`various ADCs in clinical development, U3-1402, DS-1062, DS-7300, and DS-6157, “all use the
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`same linker as DS-8201.” Texas Complaint ¶ 20. SGI’s count alleging infringement refers to
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`infringement based on “making, using, selling, offering to sell, and importing into the United
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`States ADC Products, including DS-8201[.]” Texas Complaint ¶ 22 (emphasis added).
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`24.
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`No entity has been licensed by FDA to sell any of U3-1402, DS-1062, DS-7300, or
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`DS-6157.
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`25.
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`Based on the foregoing allegations made by SGI in the Texas Complaint, there is a
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`substantial controversy of sufficient immediacy and reality between the Parties as to whether
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`Plaintiffs are infringing or have infringed the ’039 patent.
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`COUNT 1: DECLARATORY JUDGMENT OF NON-INFRINGEMENT
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`26.
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`27.
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`Paragraphs 1–25 are incorporated by reference as if fully set forth herein.
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`As set forth above, SGI has asserted the ʼ039 patent against the making, using,
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`selling, offering to sell, and importing into the United States of ENHERTU®, the product sold by
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`Plaintiff DSI and co-marketed by Plaintiff AstraZeneca. Plaintiffs, however, have not infringed
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`and do not infringe any claim of the ʼ039 patent, either directly or indirectly, literally or under the
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`Case 1:20-cv-01524-LPS Document 1 Filed 11/13/20 Page 8 of 10 PageID #: 8
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`doctrine of equivalents. Among other reasons, ENHERTU® (depicted and described above) does
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`not fall within the scope of any claim of the ’039 patent.
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`28.
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`As set forth above, SGI also has asserted the ’039 patent against various ADCs that
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`have not been approved for marketing by the FDA. Plaintiffs have not infringed and do not
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`infringe any claim of the ʼ039 patent, either directly or indirectly, literally or under the doctrine of
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`equivalents, with respect to these ADCs. Among other reasons, Plaintiffs do not infringe the
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`ʼ039 patent with respect to these ADCs because any conduct involving these ADCs is protected
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`from infringement by statute, 35 U.S.C. § 271(e)(1).
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`29.
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`SGI’s litigious history, the infringement allegations by SGI against DSC, and
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`Plaintiffs’ denial of infringement have created a substantial, immediate, and real controversy
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`between the Parties as to the non-infringement of the ʼ039 patent. A valid and justiciable
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`controversy has arisen and exists between SGI and Plaintiffs within the meaning of 28 U.S.C.
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`§ 2201.
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`30.
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`Plaintiffs seek a declaration that they have not and do not infringe any claim of the
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`’039 patent and that they are not otherwise liable for infringement, and SGI is entitled to no relief.
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`31.
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`On information and belief, absent a declaration of non-infringement of the
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`’039 patent, SGI will assert the ’039 patent against Plaintiffs and will in this way cause damage to
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`Plaintiffs.
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`PRAYER FOR RELIEF
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`WHEREFORE, Plaintiffs respectfully request that this Court enter judgment in their favor
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`against SGI and grant the following relief:
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`A. Judgment that Plaintiffs have not and do not infringe any claim of the ʼ039 patent;
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`B. Judgment entered in favor of Plaintiffs and against SGI on Plaintiffs’ claim;
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`Case 1:20-cv-01524-LPS Document 1 Filed 11/13/20 Page 9 of 10 PageID #: 9
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`C. A declaration that this is an exceptional case and an award of attorneys’ fees pursuant to
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`35 U.S.C. § 285;
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`D. An award of Plaintiffs’ costs and expenses in this action; and
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`E. Such further relief as this court may deem just and proper.
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`JURY DEMAND
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`Plaintiffs, by and through their undersigned counsel, hereby demand, pursuant to Fed. R. Civ.
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`P. 38, a trial by jury on all claims so triable in this action.
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`ASHBY & GEDDES
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`/s/ Steven J. Balick
`Steven J. Balick (#2114)
`Andrew C. Mayo (#5207)
`500 Delaware Avenue, 8th Floor
`P.O. Box 1150
`Wilmington, DE 19899
`(302) 654-1888
`sbalick@ashbygeddes.com
`amayo@ashbygeddes.com
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`Attorneys for Plaintiffs Daiichi Sankyo, Inc. and 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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`Case 1:20-cv-01524-LPS Document 1 Filed 11/13/20 Page 10 of 10 PageID #: 10
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`Naveen Modi
`Michael A. Stramiello
`Paul Hastings LLP
`2050 M Street NW
`Washington, D.C. 20036
`(202) 551-1700
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`Attorneys for Plaintiffs Daiichi Sankyo, Inc. and Daiichi
`Sankyo Company, Limited
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`MCCARTER & ENGLISH, LLP
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`/s/ Daniel M. Silver
`Michael P. Kelly (#2295)
`Daniel M. Silver (#4758)
`Alexandra M. Joyce (#6423)
`Renaissance Centre
`405 N. King Street, 8th Floor
`Wilmington, Delaware 19801
`Tel.: (302) 984-6300
`Fax: (302) 984-6399
`mkelly@mccarter.com
`dsilver@mccarter.com
`ajoyce@mccarter.com
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`Attorneys for Plaintiff AstraZeneca Pharmaceuticals LP
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`OF COUNSEL:
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`David I. Berl
`Thomas S. Fletcher
`Williams & Connolly LLP
`725 Twelfth St. NW
`Washington, DC 20005
`(202) 434-5000
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`Attorneys for Plaintiff AstraZeneca Pharmaceuticals LP
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`Dated: November 13, 2020
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