Case 1:21-cv-00550-UNA Document 1 Filed 04/16/21 Page 1 of 15 PageID #: 1
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
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`Civil Action No. __________________
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`)))))))))))
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`))
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`
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`ASTRAZENECA AB and
`ASTRAZENECA PHARMACEUTICALS LP,
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`Plaintiffs,
`
`v.
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`ZYDUS PHARMACEUTICALS (USA), INC.,
`AND CADILA HEALTHCARE LTD.,
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`Defendants.
`_____________________________________
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`COMPLAINT
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`Plaintiffs AstraZeneca AB and AstraZeneca Pharmaceuticals LP (collectively
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`“AstraZeneca” or “Plaintiffs”), by their attorneys, for their Complaint, allege as follows:
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`NATURE OF THE ACTION
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`1.
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`This is an action for patent infringement under the patent laws of the United
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`States, Title 35, United States Code that arises out of the filing by Zydus Pharmaceuticals (USA),
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`Inc. and Cadila Healthcare Ltd. (collectively, “Zydus”) of an amendment to Abbreviated New
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`Drug Application (“ANDA”) No. 214263 with the U.S. Food and Drug Administration (“FDA”)
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`seeking approval to engage in the commercial manufacture, use, offer for sale, sale, and/or
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`importation of a generic version of Plaintiffs’ Tagrisso® (osimertinib mesylate) in tablet form in
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`doses of 40 mg and 80 mg prior to the expiration of U.S. Patent No. 10,183,020 (“the ’020 patent”).
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`PARTIES
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`Plaintiffs
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`2.
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`Plaintiff AstraZeneca AB is a public limited liability company organized
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`under the laws of Sweden, with a principal place of business at Karlebyhus, Astraallén, Södertälje,
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`S-151 85, Sweden.
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`3.
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`Plaintiff AstraZeneca Pharmaceuticals LP is a limited partnership organized
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`under the laws of the State of Delaware, with a principal place of business at 1800 Concord Pike,
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`Wilmington, Delaware, 19850.
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`Defendants
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`4.
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`On information and belief, defendant Zydus Pharmaceuticals (USA) Inc.
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`(“Zydus Pharma”) is a corporation organized and existing under the laws of the State of New
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`Jersey with a principal place of business at 73 Route 31 North, Pennington, New Jersey 08534.
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`5.
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`On information and belief, defendant Cadila Healthcare Ltd. (“Cadila”) is a
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`corporation organized and existing under the laws of India, with a principal place of business at
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`Zydus Corporate Park, Scheme No. 63, Survey No. 536, Khoraj (Gandhinagar), Nr. Vasihnodevi
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`Circle, S. G. Highway, Ahmedabad 382 481, India.
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`6.
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`On information and belief, Zydus Pharma is a wholly owned subsidiary of
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`Cadila, and is controlled and dominated by Cadila. On information and belief, Zydus Pharma is
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`the U.S. agent for Cadila. Zydus has admitted in pending patent litigation concerning infringement
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`of the ’020 patent that Cadila is the manufacturer of Zydus Pharma’s ANDA Products, and that
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`Zydus Pharma is a wholly owned subsidiary of Cadila. See AstraZeneca AB et al. v. Alembic
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`Pharmaceuticals Limited et al., C.A. No. 20-202-RGA (D. Del. April 13, 2020) (“Pending
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`Infringement Action”), D.I. 19 at ¶ 20.
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`7.
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`On information and belief, Zydus Pharma is in the business of, among other
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`things, manufacturing, marketing, distributing, offering for sale, and selling generic drug products.
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`As a part of this business, on information and belief, Zydus Pharma, acting in concert with Cadila,
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`files ANDAs with the FDA seeking approval to engage in the commercial manufacture, use, offer
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`for sale, sale, and/or importation of generic versions of drug products that are covered by United
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`States patents. On information and belief, as part of these ANDAs, Zydus Pharma, acting in
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`concert with Cadila, files certifications of the type described in Section 505(j)(2)(A)(vii)(IV) of
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`the Federal Food, Drug, and Cosmetic Act to engage in the commercial manufacture, use, offer
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`for sale, sale, and/or importation of generic drug products prior to the expiration of United States
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`patents that cover such products.
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`8.
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`On information and belief, Zydus Pharma and Cadila acted in concert to
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`prepare, submit, and amend ANDA No. 214263 for their 40 mg and 80 mg osimertinib mesylate
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`tablets (“Zydus’s ANDA Products”), which was done at the direction of, under the control of, and
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`for the direct benefit of Cadila.
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`JURISDICTION
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`9.
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`Jurisdiction is proper in this district pursuant to 28 U.S.C. §§ 1331, 1338(a),
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`and 2201 and 2202.
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`10.
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`11.
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`This Court has personal jurisdiction over each of Cadila and Zydus Pharma.
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`Cadila is subject to personal jurisdiction in Delaware because, among other
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`things, Cadila, itself and through its wholly owned subsidiary Zydus Pharma, has purposefully
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`availed itself of the benefits and protections of Delaware’s laws such that it should reasonably
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`anticipate being haled into court here. On information and belief, Cadila, itself and through its
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`subsidiary Zydus Pharma, develops, manufactures, imports, markets, offers to sell, and/or sells
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`generic drugs throughout the United States, including in the State of Delaware, and therefore
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`transacts business within the State of Delaware, and/or has engaged in systematic and continuous
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`business contacts within the State of Delaware. In addition, Cadila is subject to personal
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`jurisdiction in Delaware because, upon information and belief, it controls and dominates Zydus
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`Pharma and therefore the activities of Zydus Pharma in this jurisdiction are attributed to Cadila.
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`12.
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`Zydus Pharma is subject to personal jurisdiction in Delaware because,
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`among other things, it has purposely availed itself of the benefits and protections of Delaware’s
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`laws such that it should reasonably anticipate being haled into court here. On information and
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`belief, Zydus Pharma, itself and in concert with Cadila, develops, manufactures, imports, markets,
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`offers to sell, and/or sells generic drugs throughout the United States, including in the State of
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`Delaware, and therefore transacts business within the State of Delaware, and/or has engaged in
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`systematic and continuous business contacts within the State of Delaware.
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`13.
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`On information and belief, Zydus knows and intends that following any
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`approval of Zydus’s ANDA No. 214263 as amended, Zydus will manufacture and import into the
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`United States Zydus’s ANDA Products and directly or indirectly market, sell, and distribute
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`Zydus’s ANDA Products throughout the United States, including in Delaware. On information
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`and belief, following any FDA approval of ANDA No. 214263 as amended, Zydus knows and
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`intends that Zydus’s ANDA Products will be marketed, used, distributed, offered for sale, and sold
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`in the United States and within Delaware.
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`14.
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`On information and belief, Cadila and Zydus Pharma are agents of each
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`other, and/or operate in concert as integrated parts of the same business group, and enter into
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`agreements with each other that are nearer than arm’s length, including with respect to the
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`development, regulatory approval, marketing, sale, offer for sale, and distribution of generic
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`pharmaceutical products throughout the United States, including into Delaware, and including with
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`respect to Zydus’s ANDA Products at issue. On information and belief, Zydus Pharma
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`participated in, assisted, and cooperated with Cadila in the acts complained of herein.
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`15.
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`Zydus has previously used the process contemplated by the Hatch-Waxman
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`Act to challenge branded pharmaceutical companies’ patents by filing a certification of the type
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`described in Section 505(j)(2)(A)(vii)(IV) of the FDCA, 21 U.S.C. § 355(j)(2)(A)(vii)(IV), serving
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`a notice letter on those companies, and engaging in patent litigation arising from the process
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`contemplated by the Hatch-Waxman Act.
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`16.
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`On information and belief, Zydus, with knowledge of the Hatch-Waxman
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`Act process, directed Zydus’s Second Notice Letter (defined below) to, inter alia, AstraZeneca
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`Pharmaceuticals LP, to an address in Delaware, and alleged in Zydus’s Second Notice Letter that
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`the ’020 patent will not be infringed by the commercial manufacture, use or sale of Zydus’s ANDA
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`Products. On information and belief, Zydus knowingly and deliberately challenged the ’020 patent
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`in its Second Notice Letter knowing that each time it did so it was triggering a forty-five day period
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`for Plaintiffs to bring an action for patent infringement under the Hatch-Waxman Act.
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`17.
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`Because AstraZeneca Pharmaceuticals LP is a limited partnership organized
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`in Delaware, it suffers injury and consequences from Zydus’s submission of an amendment to
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`Zydus’s ANDA No. 214263, and challenging the ’020 patent in Delaware.
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`18.
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`Zydus Pharma has been a litigant in connection with other infringement
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`actions under the Hatch-Waxman Act, and reasonably should have anticipated that by sending
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`Zydus’s Second Notice Letter to a Delaware entity, it would be sued in Delaware for patent
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`infringement.
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`19.
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`Cadila and Zydus Pharma regularly engage in patent litigation concerning
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`FDA-approved branded drug products in this district, do not contest personal jurisdiction in this
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`district, and have availed themselves of the rights and benefits of this Court by asserting claims
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`and/or counterclaims in this Court, see, e.g., Currax Pharmaceuticals LLC v. Zydus
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`Pharmaceuticals (USA) Inc. et al., No. 19-1569-RGA, D.I. 11 (D. Del. Jan. 17, 2020); Boehringer
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`Ingelheim Pharmaceuticals Inc. et al. v. Zydus Pharmaceuticals (USA) Inc. et al., No. 19-1501-
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`CFC, D.I. 9 (D. Del. Sep. 4, 2019); Merck Sharp & Dohme Corp. v. Zydus Pharmaceuticals (USA)
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`Inc., No. 19-314-RGA, D.I. 11 (D. Del. Mar. 18, 2019); Astrazeneca AB v. Zydus Pharms. (USA)
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`Inc., No. 18-664-RGA, D.I. 9 (D. Del. June 22, 2018); Biogen Int’l GmbH v. Zydus Pharms. (USA)
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`Inc., No. 18-623-LPS, D.I. 8 (D. Del. June 1, 2018); H. Lundbeck A/S v. Zydus Pharms. (USA)
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`Inc., No. 18-150-LPS, D.I. 13 (D. Del. Apr. 2, 2018); Millennium Pharms., Inc. v. Zydus Pharms.
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`(USA) Inc., No. 17-423-CFC, D.I. 9 (D. Del. May 24, 2017). Cadila and Zydus Pharma, in
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`particular, presently are engaged in the Pending Infringement Action in this district. Accordingly,
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`this Court has personal jurisdiction over Zydus.
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`20.
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`On information and belief, if ANDA No. 214263 as amended is approved,
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`Zydus will directly or indirectly manufacture, market, sell, and/or distribute Zydus’s ANDA
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`Products within the United States, including in Delaware, consistently with Zydus’s practices for
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`the marketing and distribution of other generic pharmaceutical products. On information and
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`belief, Zydus regularly does business in Delaware, and its practices with other generic
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`pharmaceutical products have involved placing those products into the stream of commerce for
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`distribution throughout the United States, including in Delaware. On information and belief,
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`Zydus’s generic pharmaceutical products are used and/or consumed within and throughout the
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`United States, including in Delaware. On information and belief, Zydus’s ANDA Products will
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`be prescribed by physicians practicing in Delaware, dispensed by pharmacies located within
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`Delaware, and used by patients in Delaware. On information and belief, each of these activities
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`would have a substantial effect within Delaware and would constitute infringement of the ’020
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`patent in the event that Zydus’s ANDA No. 214263 as amended is approved before the ’020 patent
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`expires.
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`21.
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`On information and belief, Zydus derives substantial revenue from
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`pharmaceutical products that are used and/or consumed within Delaware, and which are
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`manufactured by Zydus and/or for which Cadila or Zydus Pharma is the named applicant on
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`approved ANDAs. On information and belief, various products for which Cadila or Zydus Pharma
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`is the named applicant on approved ANDAs are available at retail pharmacies in Delaware.
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`VENUE
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`22.
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`Venue is proper in this district for Cadila pursuant to 28 U.S.C. §§ 1391 and
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`1400(b) because, inter alia, Cadila is a corporation organized and existing under the laws of India
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`and is subject to personal jurisdiction in this judicial district.
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`23.
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`Venue is proper in this district as to Zydus Pharma under 28 U.S.C. §§ 1391
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`and 1400(b) because, inter alia, Zydus Pharma is subject to personal jurisdiction in this judicial
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`district, has previously consented to venue in this judicial district, and on information and belief is
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`subject to venue in this judicial district and/or will consent to venue for the purpose of this case.
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`Zydus Pharma has, in particular, consented to venue in related patent litigation in this district
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`concerning infringement of the ’020 patent in the Pending Infringement Action.
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`24.
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`On information and belief, Cadila and Zydus Pharma are part of a broader
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`network of affiliated entities sometimes called the Zydus group. On information and belief,
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`entities affiliated with the Zydus group reside and/or maintain a regular and established place of
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`business within Delaware. Those entities include Zydus Healthcare (USA) LLC (“Zydus
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`Healthcare”)—which, on information and belief, is a limited liability company organized under
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`the laws of Delaware—and Zydus Holding Inc. (“Zydus Holding”)—which, on information and
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`belief, is a corporation formed under Delaware law. On information and belief, each of Zydus
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`Healthcare and Zydus Holding is a wholly owned subsidiary of Cadila and is controlled and
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`dominated by Cadila.
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`25.
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`On information and belief, the Zydus corporate family operates as a single,
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`integrated business. On information and belief, Zydus Pharma, Cadila, Zydus Healthcare, and
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`Zydus Holding are agents of each other, and/or operate in concert as integrated parts of the same
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`business group, and enter into agreements with each other that are nearer than arm’s length,
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`including with respect to the development, regulatory approval, marketing, sale, offer for sale, and
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`distribution of generic pharmaceutical products throughout the United States, including into
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`Delaware, and including with respect to Zydus’s ANDA Products at issue.
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`26.
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`On
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`information
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`and
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`belief, Cadila maintains
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`the website
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`https://zyduscadila.com/. According to that website, “Zydus Cadila . . . is a fully integrated, global
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`healthcare provider.” (https://zyduscadila.com/company.) The website discusses “Zydus[’s] . . .
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`rich history and lineage,” noting that, “[i]n 1995, the group was restructured and thus was formed
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`Cadila Healthcare under the aegis of the Zydus group.” On information and belief, Zydus entities
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`often share directors and/or officers. For example, Mr. Pankaj R. Patel serves as chairman of
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`Cadila’s Board of Directors, and Dr. Sharvil P. Patel serves as Cadila’s Managing Director
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`(https://zyduscadila.com/investorzone). On information and belief, both men have served as
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`directors of Zydus Pharma as well.
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`FACTUAL BACKGROUND
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`27.
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`Plaintiffs incorporate each of the preceding paragraphs 1–26 as if fully set
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`forth herein.
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`28.
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`The ’020 patent, entitled “Pharmaceutical Compositions Comprising
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`AZD9291,” (Exhibit A hereto), was duly and legally issued on January 22, 2019, to AstraZeneca
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`AB.
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`29.
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`As set forth in greater detail in the ’020 patent, the claims of the ’020 patent,
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`incorporated by reference herein, cover pharmaceutical compositions comprising osimertinib
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`mesylate and methods of using them.
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`30.
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`31.
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`AstraZeneca AB is the assignee of the ’020 patent.
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`AstraZeneca Pharmaceuticals LP is the holder of New Drug Application
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`No. 208065 for Tagrisso® (osimertinib mesylate), which has been approved by the FDA.
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`Tagrisso® is a kinase inhibitor indicated for (i) “as adjuvant therapy after tumor resection in adult
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`patients with non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor
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`receptor (EGFR) exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved
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`test”; (ii) “the first-line treatment of adult patients with metastatic NSCLC whose tumors have
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`EGFR exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test”; and
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`(iii) “the treatment of adult patients with metastatic EGFR T790M mutation-positive NSCLC, as
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`detected by an FDA-approved test, whose disease has progressed on or after EGFR TKI therapy.”
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`Tagrisso® is for oral use and is available as tablets in 40 mg and 80 mg dosage strengths.
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`32.
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`Pursuant to 21 U.S.C. § 355, the ’020 patent has been listed in connection
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`with Tagrisso® in the FDA’s publication, Approved Drug Products with Therapeutic Equivalence
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`Evaluations, which is referred to as the “Orange Book.” The ’020 patent is associated with, inter
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`alia, use code U-3016 in the Orange Book.
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`33.
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`AstraZeneca will be substantially and irreparably damaged by infringement
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`of the ’020 patent.
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`COUNT I – ZYDUS’S INFRINGEMENT OF THE ’020 PATENT UNDER
`35 U.S.C. § 271(e)(2)(A)
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`34.
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`Plaintiffs incorporate each of the preceding paragraphs 1–33 as if fully set
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`forth herein.
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`35.
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`By letter dated January 14, 2020, Zydus notified Plaintiffs that it had
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`submitted to the FDA ANDA No. 214263, seeking approval from the FDA to engage in the
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`commercial manufacture, use and/or sale of Zydus’s ANDA Products prior to the expiration of the
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`’020 patent (“Zydus’s First Notice Letter”). On information and belief, the purpose of the
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`submission of ANDA No. 214263 was to obtain approval to engage in the commercial
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`manufacture, use, offer for sale, sale and/or importation of Zydus’s ANDA Products prior to the
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`expiration of the ’020 patent.
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`36.
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`In Zydus’s First Notice Letter, Zydus also notified Plaintiffs that, as part of
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`ANDA No. 214263, Zydus had filed certifications of the type described in Section
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`505(j)(2)(A)(vii)(IV) of the FDCA, 21 U.S.C. § 355(j)(2)(A)(vii)(IV), with respect to the ’020
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`patent. On information and belief, Zydus submitted ANDA No. 214263 to the FDA containing a
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`certification pursuant to 21 U.S.C. § 355(j)(2)(A)(vii)(IV) asserting that the ’020 patent is invalid,
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`unenforceable, and/or will not be infringed by the manufacture, use, offer for sale, sale, and/or
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`importation of Zydus’s ANDA Products.
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`37.
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`Subsequent to receiving Zydus’s First Notice Letter, AstraZeneca sued
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`Zydus for infringement of the ’020 patent on February 11, 2020 in this district in the Pending
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`Infringement Action.
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`38.
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`By letter dated March 3, 2021, Zydus notified Plaintiffs that it had amended
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`ANDA No. 214263 “to include a revised certification pursuant to 21 U.S.C. § 355(j)(2)(A)(vii)(IV)
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`(‘Paragraph IV Certification’) to address the patent use code U-3016, with respect to” the ’020
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`Patent (“Zydus’s Second Notice Letter”). On information and belief, Zydus’s ANDA No. 214263
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`as amended contains an amended certification pursuant to 21 U.S.C. § 355(j)(2)(A)(vii)(IV)
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`asserting that the ’020 patent is invalid, unenforceable, and/or will not be infringed by the
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`manufacture, use, offer for sale, sale, and/or importation of Zydus’s ANDA Products. Zydus’s
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`Second Notice Letter indicates that Zydus seeks approval from the FDA to engage in the
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`commercial manufacture, use and/or sale of Zydus’s ANDA Products prior to the expiration of the
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`’020 patent. On information and belief, the purpose of amending ANDA No. 214263 was to obtain
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`approval to engage in the commercial manufacture, use, offer for sale, sale and/or importation of
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`Zydus’s ANDA Products prior to the expiration of the ’020 patent.
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`39.
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`According to information in Zydus’s Second Notice Letter, Zydus’s ANDA
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`Products are a generic version of Tagrisso® tablets.
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`40.
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`On information and belief, Zydus’s ANDA Products are not publicly
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`available, nor is ANDA No. 214263 as amended accessible to the public.
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`41.
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`Plaintiffs are filing this Complaint within forty-five days of receipt of
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`Zydus’s Second Notice Letter.
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`42.
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`According to Zydus’s Second Notice Letter, Zydus’s ANDA Products
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`contain osimertinib. On information and belief, the osimertinib in Zydus’s ANDA Products is in
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`the form of osimertinib mesylate. On information and belief, Zydus’s ANDA Products contain
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`osimertinib mesylate in an amount that literally satisfies the requirements of claim 1 of the ’020
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`patent.
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`43.
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`On information and belief, Zydus’s ANDA Products are in the form of oral
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`tablets for pharmaceutical use. Accordingly, Zydus’s ANDA Products are pharmaceutical tablets.
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`44.
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`On information and belief, Zydus’s ANDA Products contain inactive
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`ingredients that satisfy, literally and/or by equivalents, the limitations of claim 1 concerning
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`materials other than osimertinib mesylate that are contained in the claimed pharmaceutical
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`composition. Zydus’s Second Notice Letter did not contest that Zydus’s ANDA Products literally
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`satisfy various limitations of claim 1 of the ’020 patent.
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`45.
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`On information and belief, and in light of Zydus’s Second Notice Letter, the
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`proposed amended product labeling for Zydus’s ANDA Products provides, inter alia, that Zydus’s
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`ANDA Products are indicated as adjuvant therapy after tumor resection in adult patients with non-
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`small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR)
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`exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test. The
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`proposed amended product labeling for Zydus’s ANDA Products thus directs, encourages, and
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`induces a method of treating cancer in a patient in need thereof, which method comprises the oral
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`administration of an effective number of tablets that are Zydus’s ANDA Products to the patient,
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`wherein the cancer is non-small cell lung cancer.
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`46.
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`In Zydus’s Second Notice Letter, Zydus did not contest the validity of any
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`claim of the ’020 patent.
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`47.
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`Zydus has now, and has had since at least before submitting ANDA No.
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`214263, knowledge of the ’020 patent.
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`48.
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`Zydus’s submission of the amendment to ANDA No. 214263 for the
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`purpose of obtaining approval to engage in the commercial manufacture, use, offer for sale, sale,
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`and/or importation of Zydus’s ANDA Products before the expiration of the ’020 patent was an act
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`of infringement of that patent under 35 U.S.C. § 271(e)(2)(A).
`
`49.
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`On information and belief, Zydus will engage in the manufacture, use, offer
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`for sale, sale, marketing, distribution, and/or importation of Zydus’s ANDA Products, together
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`with their proposed amended product labeling, immediately and imminently upon approval of
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`ANDA No. 214263 as amended and expiration of any other Orange Book-listed patent or relevant
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`exclusivity for Tagrisso®.
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`50.
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`On information and belief, the manufacture, use (including the use of
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`Zydus’s ANDA Products in accordance with, and as directed by Zydus’s proposed amended
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`product labeling for Zydus’s ANDA Products), sale, offer for sale, and/or importation of Zydus’s
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`ANDA Products would infringe, literally and/or under the doctrine of equivalents, one or more
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`claims of the ’020 patent, including at least claims 1, 8, 9, and 11-13.
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`51.
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`On information and belief, Zydus plans and intends to, and will, actively
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`induce infringement of the ’020 patent when ANDA No. 214263 as amended is approved, and
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`plans and intends to, and will, do so immediately and imminently upon approval.
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`52.
`
`On information and belief, the foregoing actions by Zydus constitute and/or
`
`will constitute infringement of the ’020 patent and active inducement of infringement of the ’020
`
`patent.
`
`53.
`
`Unless Zydus is enjoined from infringing the ’020 patent and actively
`
`inducing infringement of the ’020 patent, Plaintiffs will suffer irreparable injury. Plaintiffs have
`
`no adequate remedy at law.
`
`13
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`

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`Case 1:21-cv-00550-UNA Document 1 Filed 04/16/21 Page 14 of 15 PageID #: 14
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`COUNT II – DECLARATORY JUDGMENT OF INFRINGEMENT BY ZYDUS OF
`THE ’020 PATENT
`
`54.
`
`Plaintiffs incorporate each of the preceding paragraphs 1–53 as if fully set
`
`forth herein.
`
`55.
`
`The Court may declare the rights and legal relations of the parties pursuant
`
`to 28 U.S.C. §§ 2201 and 2202 because there is a case of actual controversy between Plaintiffs on
`
`the one hand and Zydus on the other regarding Zydus’s liability for infringement and active
`
`inducement of infringement of the ’020 patent.
`
`56.
`
`The Court should declare that the commercial manufacture, use, sale, offer
`
`for sale or importation of Zydus’s ANDA Products will infringe and induce the infringement of
`
`the ’020 patent.
`
`WHEREFORE, Plaintiffs request the following relief:
`
`(a)
`
`(b)
`
`A judgment that Zydus has infringed the ’020 patent;
`
`A judgment ordering that the effective date of any FDA approval of
`
`commercial manufacture, use, or sale of Zydus’s ANDA Products be not earlier than the expiration
`
`of the ’020 patent, inclusive of any extension(s) and additional period(s) of exclusivity;
`
`(c)
`
`A preliminary and permanent injunction enjoining Zydus, and all persons
`
`acting in concert with Zydus, from the commercial manufacture, use, sale, offer for sale, or
`
`importation into the United States of Zydus’s ANDA Products prior to the expiration of the ’020
`
`patent, inclusive of any extension(s) and additional period(s) of exclusivity;
`
`(d)
`
`A judgment declaring that the commercial manufacture, use, sale, offer for
`
`sale or importation of Zydus’s ANDA Products prior to the expiration of the ’020 patent will
`
`infringe and induce the infringement of the ’020 patent;
`
`14
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`

`

`Case 1:21-cv-00550-UNA Document 1 Filed 04/16/21 Page 15 of 15 PageID #: 15
`
`(e)
`
`A declaration that this is an exceptional case and an award of attorneys’ fees
`
`pursuant to 35 U.S.C. § 285;
`
`(f)
`
`(g)
`
`Costs and expenses in this action; and
`
`Such further and other relief as this Court may deem just and proper.
`
`Dated: April 16, 2021
`
`MCCARTER & ENGLISH, LLP
`
` Respectfully submitted,
`
`OF COUNSEL:
`
`Jessamyn S. Berniker
`Dov P. Grossman
`Vidya A. Mirmira
`Christopher A. Yeager
`Jingyuan Luo
`Sumeet P. Dang
`WILLIAMS & CONNOLLY LLP
`725 Twelfth Street, N.W.
`Washington, DC 20005
`(202) 434-5000
`(202) 434-5029 (Facsimile)
`
`/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
`(302) 984-6300
`mkelly@mccarter.com
`dsilver@mccarter.com
`ajoyce@mccarter.com
`
`Attorneys for Plaintiffs AstraZeneca AB and
`AstraZeneca Pharmaceuticals LP
`
`15
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`