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Case 2:20-cv-00337-JRG Document 129 Filed 07/29/21 Page 1 of 17 PageID #: 5677
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`IN THE UNITED STATES DISTRICT COURT
`EASTERN DISTRICT OF TEXAS
`MARSHALL DIVISION
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`
`
`
`
`
`CASE NO. 2:20-cv-00337-JRG
`
`JURY TRIAL DEMANDED
`
`SEAGEN INC.,
`
`
`Plaintiff,
`
`
`v.
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`DAIICHI SANKYO CO., LTD.,
`
`
`Defendant,
`
`
`ASTRAZENECA PHARMACEUTICALS
`LP and ASTRAZENECA UK LTD.,
`
`
`Intervenor-Defendants.
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`ASTRAZENECA’S
`ANSWER TO PLAINTIFF’S COMPLAINT
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`AstraZeneca Pharmaceuticals LP and AstraZeneca UK Limited
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`(collectively
`
`“AstraZeneca”), by and through undersigned counsel, answer the Complaint1 of Plaintiff Seagen
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`Inc. (“Seagen”) as follows. This document republishes the allegations from Seagen’s Complaint,
`
`but for clarity, AstraZeneca does not adopt those allegations. AstraZeneca’s responses follow each
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`such allegation and are prefaced “ANSWER.”
`
`1.
`
`Seagen brings this action to protect its proprietary technology enabling the delivery
`
`of chemotherapeutic drugs directly to cancer cells. When Seagen began developing this
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`technology, most chemotherapeutic drugs for cancer were not targeted, resulting in the delivery of
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`treatments throughout the patient’s body and causing significant adverse side effects. Since then,
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`Seagen’s pioneering innovations in the field of antibody-drug conjugates (ADCs), a type of
`
`
`1 AstraZeneca does not believe that this heading or any of the headings in Seagen’s Complaint require a
`response. If a response is required, AstraZeneca denies each and any allegations, express or implied, in
`such headings.
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`

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`Case 2:20-cv-00337-JRG Document 129 Filed 07/29/21 Page 2 of 17 PageID #: 5678
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`therapy that directly targets chemotherapeutic drugs to cancer cells, have helped establish ADCs
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`as an important pillar of cancer therapy. Seagen’s ADC technology is the result of decades of
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`research and development effort by Seagen’s scientists and hundreds of millions of dollars of
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`investment. Seagen’s transformative innovations have maintained Seagen’s leadership status even
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`as other companies have entered the field, and Seagen’s innovations are embodied in more
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`approved ADC therapies than those of any other company. DSC is a new entrant in the ADC field,
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`and it infringes Seagen’s United States Patent No. 10,808,039 (the “’039 patent”). DSC has
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`already booked tens of millions of dollars in sales of an infringing product, and appears intent upon
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`expanding its infringing activities.
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`ANSWER: AstraZeneca denies each and every allegation in Paragraph 1.
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`2.
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`ADCs are specialized cancer treatments that use a “linker” to attach (or
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`“conjugate”) chemotherapeutic drugs to an antibody. The antibody in an ADC targets receptors
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`on the surface of a cancer cell. The targeted cell then internalizes the ADC, releasing the ADC’s
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`chemotherapeutic drug to kill the cancer cell. This technology is cutting edge. To date, only nine
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`ADCs have been approved by the FDA.
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`ANSWER: AstraZeneca admits that Seagen attempts to describe antibody-drug
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`conjugates, but Seagen’s description is very general, incomplete, and misleading. AstraZeneca
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`further admits that Seagen attempts to allege that, as of the date of Seagen’s Complaint, only nine
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`antibody-drug conjugates have been approved by the FDA. However, it is not clear to which type
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`of FDA approval Seagen’s Complaint refers, so AstraZeneca denies this allegation. Except as
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`admitted, AstraZeneca denies each and every allegation in Paragraph 2.
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`3.
`
`After its founding in 1998, Seagen pioneered a class of linkers with a cleavable
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`amino acid unit for use in ADCs. This class is often referred to as “protease cleavable” because
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`2
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`Case 2:20-cv-00337-JRG Document 129 Filed 07/29/21 Page 3 of 17 PageID #: 5679
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`specialized enzymes within the cell called “proteases” cleave the bonds of the amino acid unit to
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`release the drug. After more than ten years of fundamental research, Seagen received FDA
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`approval for its first ADC employing this technology, ADCETRIS®, in 2011. Of the nine, now-
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`approved ADCs, more use Seagen’s linker technologies than any other.
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`ANSWER: AstraZeneca admits that Seagen received a FDA approval in 2011 for the
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`antibody-drug conjugate known as Adcetris®. Except as admitted, AstraZeneca denies each and
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`every allegation in Paragraph 3.
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`4.
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`All of the products in DSC’s ADC pipeline also use a protease cleavable linker that
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`is covered by the claims of Seagen’s ’039 patent. The currently accused product is DSC’s DS-
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`8201 ADC (now branded ENHERTU®), the first ADC in DSC’s pipeline to be FDA approved.
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`On January 6, 2020, DSC announced DS-8201’s availability in the United States, noting that DSC
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`would be solely responsible for manufacturing and supply. DSC causes DS-8201 to be imported
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`into, offered for sale, sold, and used in the United States. DSC also ultimately books the United
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`States sales of DS-8201, and these sales have totaled more than $70 million to date.
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`ANSWER: AstraZeneca denies each and every allegation in Paragraph 4.
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`5.
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`DSC may seek FDA approval for its other pipeline products covered by the claims
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`of the ’039 patent, including U3-1402, DS-1062, DS-7300, DS-6157, in the near future. Seagen
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`intends by this Complaint that these products also be accused products should Seagen learn during
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`the course of discovery that DSC has engaged in infringing activities as to these products.
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`ANSWER: AstraZeneca lacks knowledge or information sufficient to form a belief as to
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`the truth of what Seagen intends by its Complaint and denies that allegation on that basis.
`
`AstraZeneca denies each and every remaining allegation in Paragraph
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`3
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`Case 2:20-cv-00337-JRG Document 129 Filed 07/29/21 Page 4 of 17 PageID #: 5680
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`THE PARTIES
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`6.
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`Plaintiff Seagen is a biotechnology company formerly known as Seattle Genetics,
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`Inc. Seagen develops and commercializes transformative therapies targeting cancer. Seagen is
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`headquartered in Bothell, Washington, and incorporated under the laws of Delaware.
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`ANSWER: AstraZeneca admits that Seagen is a biotechnology company formerly known
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`as Seattle Genetics, Inc. On information and belief, AstraZeneca further admits that Seagen is a
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`headquartered in Bothell, Washington, and is incorporated under the laws of Delaware. Except as
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`admitted, AstraZeneca denies each and every allegation in Paragraph 6.
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`7.
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`Defendant DSC is a Japanese pharmaceutical corporation having its principal place
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`of business at 3-5-1, Nihonbashi Honchō, Chūo-ku, Tokyo 103-8426, Japan.
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`ANSWER: On information and belief, AstraZeneca admits that Daiichi Sankyo Company,
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`Limited is a Japanese corporation with its principal place of business at 3-5-1, Nihonbashi,
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`Honchō, Chūo-ku, Tokyo 103-8426, Japan.
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`JURISDICTION AND VENUE
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`8.
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`This Court has subject matter jurisdiction under 28 U.S.C. 1331 and under 28
`
`U.S.C. § 1400(b).
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`ANSWER: AstraZeneca denies each and every allegation in Paragraph 8.
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`9.
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`This Court has personal jurisdiction over DSC, as DSC conducts business and has
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`committed acts of patent infringement, induced acts of patent infringement, and contributed to
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`patent infringement in the United States, the State of Texas, and the Eastern District of Texas.
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`ANSWER: AstraZeneca denies each and every allegation in Paragraph 9.
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`10.
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`DSC also has sufficient minimum contacts with the forum as a result of business it
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`conducts within Texas and this district. DSC—directly or through subsidiaries or intermediaries
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`4
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`Case 2:20-cv-00337-JRG Document 129 Filed 07/29/21 Page 5 of 17 PageID #: 5681
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`including distributors, retailers, and others—offers for sale, and sells (as well distributes,
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`advertises, and markets) products, including DS-8201, that infringe the ’039 patent throughout
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`Texas and this district. For example, DSC owns the U.S. registration for the ENHERTU®
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`trademark for DS-8201. DSC acts in concert with others to purposefully and voluntarily place the
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`infringing products in a distribution chain that foreseeably leads to the infringing products being
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`offered for sale, sold, and used in Texas and this district as part of the ordinary stream of
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`commerce. DSC has done so with the expectation that these infringing products have been, and
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`will continue to be, purchased in Texas and this district and that such purchases be part of the
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`ordinary stream of commerce.
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`ANSWER: Daiichi Sankyo Japan owns the registration for the Enhertu® trademark for
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`DS-8201. AstraZeneca denies the remaining allegations in Paragraph 10.
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`11.
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`In addition, DSC’s subsidiaries and contractual business partners have operated as
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`agents of DSC as parts of a business group in which executives of DSC make important operational
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`decisions regarding the manufacture, importation, offer for sale, sale, and intended use of the
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`infringing products, including DS-8201. Through these agents, DSC has conducted business and
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`committed acts of infringement in the United States, Texas, and this district.
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`ANSWER: AstraZeneca denies each and every allegation in Paragraph 11.
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`12.
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`Alternatively, to the extent that DSC is not subject to jurisdiction in any state court
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`of general jurisdiction, this Court may exercise jurisdiction over DSC pursuant to Federal Rule of
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`Civil Procedure 4(k)(2) because: (a) Seagen’s claims arise under federal law; and (b) DSC has
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`sufficient contacts with the United States as a whole, including but not limited to manufacturing
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`the infringing products and importing them into the United States and offering for sale, selling,
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`5
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`Case 2:20-cv-00337-JRG Document 129 Filed 07/29/21 Page 6 of 17 PageID #: 5682
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`and causing them to be sold in the United States, such that this Court’s exercise of jurisdiction
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`over DSC satisfies due process.
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`ANSWER: AstraZeneca denies each and every allegation in Paragraph 12.
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`13.
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`Venue is proper in this judicial district pursuant to 28 U.S.C. § 1400(b) and 28
`
`U.S.C. § 1391(c). DSC is a foreign corporation and may be sued in this district. Venue is further
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`proper because DSC has committed acts of infringement in this district, and has purposely
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`transacted business involving the infringing products in this district.
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`ANSWER: AstraZeneca denies each and every allegation in Paragraph 13.
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`PATENT-IN-SUIT – U.S. PATENT NO. 10,808,039
`
`14.
`
`Seagen is the sole owner of the ’039 patent and holds the sole right to enforce it.
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`The ’039 patent claims priority to provisional applications filed on November 6, 2003, and March
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`26, August 4, and October 27, 2004. The inventors were all employees of Seagen at the time
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`the priority applications were filed. Although the ’039 patent issued recently, DSC has been
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`aware of one or more parent applications of the ’039 patent since at least 2008, and it has been
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`aware of the specific application that issued as the ’039 patent since at least June of this year.
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`DSC also has notice of the ’039 patent from the filing of this Complaint.
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`ANSWER: AstraZeneca lacks knowledge or information sufficient to form a belief as to
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`the truth of Seagen’s alleged ownership of the ’039 patent and whether Seagen has the sole right
`
`to enforce it, and denies that allegation on that basis. AstraZeneca denies each and every remaining
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`allegation in Paragraph 14.
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`15.
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`The ’039 patent claims technologies associated with ADCs. At the time of the
`
`invention, most therapeutics administered to patients to treat cancer—such as chemotherapeutic
`
`drugs—were not targeted to cancer cells, resulting in systemic delivery of the therapeutics to cells
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`6
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`Case 2:20-cv-00337-JRG Document 129 Filed 07/29/21 Page 7 of 17 PageID #: 5683
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`and tissues of the body, including to healthy cells where they are unnecessary, often undesirable,
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`and can cause considerable adverse side effects. In the late 1990s, custom designed antibodies
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`were developed as targeted agents for the treatment of cancer and certain autoimmune diseases,
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`but they, too, had limitations. Combining these antibodies with chemotherapy drugs to deliver
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`them in a targeted fashion was under investigation as a next-generation technology, and
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`chemotherapeutic drugs that bind tubulin (an important protein for cell division), bind DNA, or
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`inhibit topoisomerases (enzymes involved in DNA replication and transcription) were known to
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`be leading candidates. But linkers that would release drugs only in the target cells proved elusive.
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`The first ADC to reach the market had to be withdrawn due to off-target effects thought to be
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`caused by an unstable linker that disassociated before the ADC reached the intended target.
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`ANSWER: AstraZeneca admits that Seagen attempts to state what the ’039 patent 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, AstraZeneca denies each
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`and every allegation in Paragraph 15.
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`16.
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`Seagen’s path-breaking work led to the development of protease-cleavable ADC
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`linkers that were more stable (and thus more likely to deliver chemotherapeutic drugs to target
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`cancer cells) than other linker types, and included research on a range of amino acid motifs that
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`could be used in such linkers. Seagen also developed more predictable “cysteine” conjugation
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`technology (technology which differs from the “lysine” conjugation technology favored by other
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`companies), and technology for arriving at a desired drug-to-antibody ratio or “DAR” (a term that
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`refers to the number of drug units linked to each antibody).
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`ANSWER: AstraZeneca denies each and every allegation in Paragraph 16.
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`7
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`Case 2:20-cv-00337-JRG Document 129 Filed 07/29/21 Page 8 of 17 PageID #: 5684
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`ALLEGED INFRINGEMENT
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`17.
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`The claims of the ’039 patent are directed to antibody-drug conjugates comprising
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`a protease cleavable linker of four amino acids in length, wherein each amino acid is either glycine
`
`or phenylalanine. The ’039 patent is enforceable and valid, and DSC’s ADC products fall within
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`the scope of the patent rights provided by the claims of the ’039 patent.
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`ANSWER: AstraZeneca denies each and every allegation in Paragraph 17.
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`18.
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`The claims of the ’039 patent cover ADCs with linkers having the formula – Aa—
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`Ww—Yy–, wherein Aa is a stretcher unit that bonds to a sulfur atom of the amino acid cysteine in
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`the antibody, Ww is an amino acid unit, and Yy is a spacer unit between the amino acid unit and
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`the drug. Independent claim 1 provides that the stretcher unit Aa is the maleimide
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`maleimidocaproyl, or “mc,” as shown in the diagram below.
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`ANSWER: AstraZeneca denies each and every allegation in Paragraph 18.
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`19.
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`Claim 1 further provides that the amino acid unit Ww is a tetrapeptide of four amino
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`acids in length, with each amino acid having the formula shown below in which R19 is either
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`hydrogen (i.e., the amino acid glycine, or “G”) or benzyl (i.e., the amino acid phenylalanine, or
`
`
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`“F”):
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`ANSWER: AstraZeneca denies each and every allegation in Paragraph 19.
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`20.
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`Claim 4, which includes the limitations of claims 1, 2, and 3, and the claims that
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`depend from claim 4, are exemplary on the issue of infringement. DSC’s ADCs with this linker
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`8
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`Case 2:20-cv-00337-JRG Document 129 Filed 07/29/21 Page 9 of 17 PageID #: 5685
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`infringe Claim 4 because they comprise a maleimidocaproyl stretcher unit that bonds to a sulfur
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`atom of the amino acid cysteine in the antibody, a tetrapeptide amino acid unit with the amino acid
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`motif GGFG, and a self-immolative spacer unit. The drug-to-antibody ratio for these ADCs is
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`about 3 to about 8. The chart below provides more
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`detail regarding how DS-8201 infringes claim 4. U3-1402, DS-1062, DS-7300, DS-6157 all use
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`
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`the same linker as DS-8201.
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`Claim 4
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`DS-8201
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`1. An antibody-drug conjugate having
`
`DS-8201 is an antibody-drug conjugate. In
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`the formula:
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`DS-8201, the payload drug is conjugated to
`
`the antibody using a linker that has the
`
`claimed formula, including a stretcher unit
`
`mc, an amino acid unit Ww with the
`
`tetrapeptide motif GGFG, and an
`
`
`aminomethylene spacer unit Yy:
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`or a pharmaceutically acceptable salt
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`thereof, wherein:
`
`
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`Ab is an antibody,
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`In DS-8201, the antibody to which drugs are
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`
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`conjugated is trastuzumab.
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`9
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`Case 2:20-cv-00337-JRG Document 129 Filed 07/29/21 Page 10 of 17 PageID #: 5686
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`S is sulfur,
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`In DS-8201, the linker’s stretcher unit mc
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`bonds to sulfur atoms on cysteine residues of
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`the antibody.
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`each -Ww - unit is a tetrapeptide; wherein each
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`In DS-8201, the linker has an amino acid unit
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`–W– unit is independently an Amino Acid
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`with the tetrapeptide motif GGFG. Glycine,
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`unit having the formula denoted below in the
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`or G, corresponds with the claimed amino
`
`square bracket:
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`acid formula wherein R19 is hydrogen.
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`Phenylalanine, or F, corresponds with the
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`claimed amino acid formula wherein R19 is
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`benzyl.
`
`
`
`, wherein R19 is hydrogen or benzyl,
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`Y is a Spacer unit,
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`In DS-8201, the linker has an
`
`aminomethylene spacer unit.
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`y is 0, 1 or 2,
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`In DS-8201, there is one spacer, so y is 1.
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`D is a drug moiety, and
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`In DS-8201, the drug that is conjugated to the
`
`antibody with the linker is the camptothecin
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`derivative DXd, which acts as a
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`topoisomerase inhibitor.
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`p ranges from 1 to about 20, and
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`In DS-8201, the value of p, which represents
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`drug loading in terms of the drug-to-antibody
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`ratio or “DAR”, is about 7.7.
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`wherein the S is a sulfur atom on a cysteine
`
`In DS-8201, the linker’s stretcher unit mc
`
`residue of the antibody, and
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`bonds to sulfur atoms on cysteine residues of
`
`
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`
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`the antibody.
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`10
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`Case 2:20-cv-00337-JRG Document 129 Filed 07/29/21 Page 11 of 17 PageID #: 5687
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`wherein the drug moiety is intracellularly
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`DS-8201’s linker is cleaved within the cell by
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`cleaved in a patient from the antibody of the
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`proteases to release the camptothecin
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`antibody-drug conjugate or an intracellular
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`derivative drug DXd.
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`metabolite of the antibody- drug conjugate.
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`2. The antibody-drug conjugate of claim 1,
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`In DS-8201, the linker’s aminomethylene
`
`wherein Y is a self-immolative spacer.
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`spacer unit is self-immolative.
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`3. The antibody-drug conjugate of claim 2,
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`In DS-8201, there is one spacer, so y is 1.
`
`wherein y is 1.
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`4. The antibody-drug conjugate of claim 3,
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`In DS-8201, the value of p, which represents
`
`wherein p is about 3 to about 8.
`
`drug loading in terms of the drug-to-antibody
`
`
`ANSWER: AstraZeneca denies each and every allegation in Paragraph 20.
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`ration or “DAR”, is about 7.7.
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`COUNT I
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`21.
`
`Seagen hereby restates and re-alleges the allegations set forth in paragraphs 1
`
`through 20 above and incorporates them by reference.
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`ANSWER: AstraZeneca repeats and realleges its answers and denials to the preceding
`
`Paragraphs as if fully set forth here.
`
`22.
`
`DSC has been and is now directly infringing, contributing to infringement, and
`
`inducing others to infringe the ’039 patent in this district and elsewhere in violation of 35 U.S.C.
`
`§ 271 at least by making, using, selling, offering to sell, and importing into the United States ADC
`
`products, including DS-8201, that meet the limitations of one or more claims of the ’039 patent.
`
`ANSWER: AstraZeneca denies each and every allegation in Paragraph 22.
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`23.
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`DSC has committed infringing acts without the permission, consent, authorization,
`
`or license of Seagen.
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`ANSWER: AstraZeneca denies each and every allegation in Paragraph 23.
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`11
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`24.
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`DSC’s infringement is literal or under the doctrine of equivalents, or both.
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`ANSWER: AstraZeneca denies each and every allegation in Paragraph 24.
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`25.
`
`DSC, in addition to its own direct infringement, is currently actively inducing and
`
`encouraging infringement of the ’039 patent, and will continue to actively induce and encourage
`
`infringement of the ’039 patent. DSC has known of the ’039 patent at least since the time of
`
`Seagen’s transmittal of this Complaint to DSC, and had prior knowledge of the application from
`
`which it issued. DSC nevertheless actively encourages others to infringe the ’039 patent such as
`
`by promoting and encouraging the use of the infringing products, including DS-8201. DSC
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`knowingly induces infringement by others, including importers, manufacturers, sellers, and users
`
`of the infringing products, including DS-8201. These facts give rise to a reasonable inference that
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`DSC knowingly induces others, including importers, manufacturers, sellers, and users, to directly
`
`infringe the ’039 patent, and that DSC possesses a specific intent to cause such infringement.
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`Importers, manufacturers, sellers, and users of the infringing products directly infringe the ’039
`
`patent.
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`ANSWER: AstraZeneca denies each and every allegation in Paragraph 25.
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`26.
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`DSC also contributes to infringement of the ’039 patent by manufacturing, offering
`
`to sell, or selling within the United States or importing into the United States components of the
`
`infringing products, including linkers such as those found in DS-8201, while having knowledge of
`
`the ’039 patent and knowledge that these components are especially made or especially adapted
`
`for use in products that infringe the ’039 patent. These components are not staple articles or
`
`commodities of commerce suitable for substantial noninfringing uses. Importers, manufacturers,
`
`sellers, and users of the infringing products including these components directly infringe the ’039
`
`patent.
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`12
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`Case 2:20-cv-00337-JRG Document 129 Filed 07/29/21 Page 13 of 17 PageID #: 5689
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`ANSWER: AstraZeneca denies each and every allegation in Paragraph 26.
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`27.
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`DSC’s infringement has been willful. DSC had knowledge of the parent
`
`applications of the ’039 patent, including the application that issued as the ’039 patent and its
`
`published claims, before the filing of this Complaint. DSC has proceeded to make, use, offer for
`
`sale, sell, and import the infringing products, including DS-8201, despite knowing that the
`
`products would infringe the ’039 patent, and DSC have continued to make, use, offer for sale, sell,
`
`and import the infringing products, including DS-8201, since the filing of this Complaint. DSC
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`was also generally aware of Seagen’s linker technology, inquired about it, and directly compared
`
`it to the linkers in DSC’s infringing products, including DS-8201, in articles, analyses, and
`
`presentations. For these and other reasons, DSC’s infringing acts have been egregious.
`
`ANSWER: AstraZeneca denies each and every allegation in Paragraph 27.
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`28.
`
`As a direct and proximate result of DSC’s infringement of the ’039 patent, Seagen
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`has suffered, and will continue to suffer damages, including lost profits.
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`ANSWER: AstraZeneca denies each and every allegation in Paragraph 28.
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`29.
`
`Seagen has also suffered damages from DSC’s infringement of Seagen’s
`
`provisional rights in the ’039 patent, as DSC was on notice of the published patent application for
`
`the ’039 patent and the issued claims are substantially identical to claims in the published
`
`application.
`
`ANSWER: AstraZeneca denies each and every allegation in Paragraph 29.
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`PRAYER FOR RELIEF
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`AstraZeneca denies that Seagen is entitled to any relief from AstraZeneca or the Court,
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`either as prayed for in the Complaint or otherwise. AstraZeneca has not infringed, either directly
`
`or indirectly, any valid and enforceable claim of the patent-in-suit, and Seagen is not entitled to
`
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`13
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`Case 2:20-cv-00337-JRG Document 129 Filed 07/29/21 Page 14 of 17 PageID #: 5690
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`any remedy or recovery. To the extent paragraphs A-F under Plaintiff’s Prayer for Relief are
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`interpreted to contain any factual allegations, AstraZeneca denies them.
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`DEFENSES
`
`AstraZeneca asserts the following defenses. In doing so, AstraZeneca does not assume the
`
`burden of proof for matters for which Seagen bears the burden. AstraZeneca also reserves all
`
`rights to allege additional defenses that become known during the litigation.
`
`First Defense
`(Non-Infringement)
`
`AstraZeneca does not infringe and has not infringed (directly, indirectly, literally or under
`
`the doctrine of equivalents) a valid and enforceable claim of the ’039 patent.
`
`Second Defense
`(Invalidity)
`
`The claims of the ’039 patent are invalid and/or unenforceable for failure to satisfy one or
`
`more of the patentability conditions set forth in Title 35 of the U.S. Code, including but not limited
`
`to 35 U.S.C. §§ 101, 102, 103, and 112.
`
`Third Defense
`(Limitation of Damages)
`
`Seagen’s claims for damages, costs, or attorneys’ fee, if any, against AstraZeneca for
`
`alleged patent infringement is limited by 35 U.S.C. §§ 286 and/or 288.
`
`Fourth Defense
`(Prosecution Laches)
`
`
`
`The claims of the ’039 patent are unenforceable and Seagen’s claims for relief are barred
`
`by the equitable doctrine of prosecution laches due to Seagen’s unreasonable and unexplained
`
`delay in the prosecution of the ’039 patent.
`
`
`
`
`
`
`
`14
`
`

`

`Case 2:20-cv-00337-JRG Document 129 Filed 07/29/21 Page 15 of 17 PageID #: 5691
`
`Fifth Defense
`(Estoppel, Waiver, and Unclean Hands)
`Seagen’s claims for relief are barred, in whole or in part, by the equitable doctrines of
`
`estoppel, waiver and/or unclean hands.
`
`Sixth Defense
`(Prosecution History Estoppel)
`
`Seagen’s infringement claims are barred by the doctrine of prosecution history estoppel
`
`based on statements, representations, and admissions made during the prosecution of the patent
`
`application resulting in the ’039 patent.
`
`Seventh Defense
`(No Exceptional Case)
`
`Seagen pleaded no valid basis for finding an exceptional case under 35 U.S.C. §285.
`
`Eighth Defense
`(Safe Harbor)
`
`AstraZeneca’s alleged activities with regard to Daiichi Sankyo Japan’s “pipeline products”
`
`that Seagen identifies in its Complaint—U3-1402, DS-1062, DS-7300, and DS-6157, do not
`
`constitute infringement as a matter of law under 35 U.S.C. § 271(e)(1).
`
`RESERVATION OF RIGHTS
`
`Defendant reserves the right to assert any additional defenses, as they become known
`
`during the course of this action, or to the extent they are not otherwise deemed affirmative defenses
`
`by law.
`
`PRAYER FOR RELIEF
`
`WHEREFORE, AstraZeneca prays for judgment that:
`
`A.
`
`B.
`
`whatsoever;
`
`
`
`Seagen’s Complaint be dismissed in its entirety with prejudice;
`
`Seagen is not entitled to any relief prayed for in its Complaint, or to any relief
`
`15
`
`

`

`Case 2:20-cv-00337-JRG Document 129 Filed 07/29/21 Page 16 of 17 PageID #: 5692
`
`C.
`
`AstraZeneca has not infringed any valid and enforceable asserted claim of the ’039
`
`patent;
`
`D.
`
`E.
`
`its Complaint;
`
`Each asserted claim of the ’039 patent is invalid and/or unenforceable;
`
`No damages or royalties are due or owing for any of the acts alleged by Seagen in
`
`F.
`
`The claims of the ’039 patent are unenforceable due to the equitable doctrine of
`
`prosecution laches;
`
`G.
`
`AstraZeneca be awarded its costs, disbursements, and reasonable attorneys’ fees
`
`pursuant to 35 U.S.C. § 285 as against Seagen; and
`
`H.
`
`AstraZeneca be granted such other and further relief as the Court may deem just
`
`and proper.
`
`JURY DEMAND
`
`AstraZeneca demands a trial by jury of all issues triable in this action.
`
`
`
`16
`
`
`
`
`
`

`

`Case 2:20-cv-00337-JRG Document 129 Filed 07/29/21 Page 17 of 17 PageID #: 5693
`
`Dated: July 29, 2021
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Respectfully submitted,
`
`
`
`/s/ Jennifer Parker Ainsworth
`Jennifer Parker Ainsworth
`Texas State Bar No. 00784720
`jainsworth@wilsonlawfirm.com
`WILSON, ROBERTSON & CORNELIUS, P.C.
`909 ESE Loop 323, Suite 400
`Tyler, Texas 75701
`Phone: (903) 509-5000
`Facsimile: (903) 509-5092
`
`David I. Berl
`dberl@wc.com
`Thomas S. Fletcher
`tfletcher@wc.com
`Jessica L. Pahl
`jpahl@wc.com
`Kathryn S. Kayali
`kkayali@wc.com
`Kevin Hoagland-Hanson
`khoagland-hanson@wc.com
`Andrew Hoffman
`ahoffman@wc.com
`WILLIAMS & CONNOLLY LLP
`725 Twelfth Street, N.W.
`Washington, DC 20005
`Phone: (202) 434-5000
`Facsimile: (202) 434-5029
`
`Attorneys for AstraZeneca Pharmaceuticals
`LP and AstraZeneca UK Ltd.
`
`CERTIFICATE OF SERVICE
`
`The undersigned certifies that the foregoing document was filed electronically in
`
`compliance with Local Rule CV-5(a). As such, this motion was served on all counsel who have
`
`consented to electronic service, Local Rule CV-5(a)(3), on this the 29th day of July, 2021.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`/s/ Jennifer P. Ainsworth
`Jennifer P. Ainsworth
`
`
`
`17
`
`

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