Case 1:21-cv-00875-UNA Document 1 Filed 06/18/21 Page 1 of 13 PageID #: 1
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`
`Civil Action No. _____
`
`))))))))))))))
`
`ASTRAZENECA AB and
`ASTRAZENECA PHARMACEUTICALS
`LP,
`
`Plaintiffs,
`
`v.
`
`ALEMBIC PHARMACEUTICALS LTD.,
`and ALEMBIC PHARMACEUTICALS,
`INC.,
`
`Defendants.
`
`COMPLAINT FOR PATENT INFRINGEMENT
`
`Plaintiffs AstraZeneca AB and AstraZeneca Pharmaceuticals LP (collectively
`
`“AstraZeneca” or “Plaintiffs”), by its attorneys, hereby 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 arising under the patent laws of the
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`United States, Title 35, United States Code, against defendants Alembic Pharmaceuticals Ltd.
`
`(“Alembic India”) and Alembic Pharmaceuticals, Inc. (“Alembic USA”) (collectively,
`
`“Alembic” or “Defendant”). This action relates to Abbreviated New Drug Application
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`(“ANDA”) No. 208576 (“ticagrelor ANDA”) filed by Defendant with the U.S. Food and Drug
`
`Administration (“FDA”) for approval to market generic versions of AstraZeneca’s BRILINTA®
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`(ticagrelor) drug product prior to expiration of AstraZeneca’s U.S. Patent Nos. 8,425,934 (“the
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`’934 patent”) and 10,300,065 (“the ’065 patent”) (collectively “the Orange Book patents”), that
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`are listed in the Approved Drug Products with Therapeutic Equivalence Evaluations (“Orange
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`Book”) for BRILINTA®.
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`PARTIES
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`2.
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`AstraZeneca is engaged in the business of creating, developing, and bringing to
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`market revolutionary biopharmaceutical products to help patients prevail against serious
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`diseases, including treatments for cardiovascular diseases.
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`3.
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`Plaintiff AstraZeneca AB is a company operating and existing under the laws of
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`Sweden, with its principal place of business at SE-151 85 Södertälje, Sweden. AstraZeneca AB
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`is the owner of the ’934 and ’065 patents.
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`4.
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`Plaintiff AstraZeneca Pharmaceuticals LP is a limited partnership operating and
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`existing under the laws of Delaware, with its principal place of business at One MedImmune
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`Way, Gaithersburg, Maryland 20878. AstraZeneca Pharmaceuticals LP is the holder of New
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`Drug Application (“NDA”) No. 022433 for BRILINTA® (ticagrelor). AstraZeneca
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`Pharmaceuticals LP markets and sells BRILINTA® in this judicial district and throughout the
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`United States. Defendant specifically directed a letter dated May 7, 2021 with the heading “Re:
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`Notification of Certification Under 21 U.S.C. § 355(j)(2)(B) of the Federal Food, Drug &
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`Cosmetic Act, and Under 21 C.F.R. § 314.95 Alembic Pharmaceuticals Ltd. – Ticagrelor Tablet
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`60 mg ANDA No. 208576” (“Notice Letter”) to AstraZeneca Pharmaceuticals LP.
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`5.
`
`On information and belief, Alembic India is a corporation organized and existing
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`under the laws of India, having a principal place of business at Alembic Road, Vadodara 390003,
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`Gujarat, India. On information and belief, Alembic India, itself and through its affiliates and
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`subsidiaries, including Alembic USA, formulates, manufactures, packages, and markets generic
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`drug products for distribution in the District of Delaware and throughout the United States.
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`6.
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`On information and belief, Alembic USA is a corporation organized and existing
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`under the laws of the State of Delaware, having a principal place of business at 750 Highway
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`202, Bridgewater, New Jersey 08807. On information and belief, Alembic USA is a wholly-
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`owned subsidiary and U.S. agent of Alembic India.
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`7.
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`On information and belief, Alembic USA is a pharmaceutical company that
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`formulates, manufactures, packages, and markets generic drug products for distribution in the
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`District of Delaware and throughout the United States.
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`8.
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`On information and belief, Alembic USA is qualified to do business in Delaware
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`and appointed a registered agent for service of process, by filing with the Secretary of State on
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`August 10, 2012 pursuant to sections 371 and 376 of title 8 of the Delaware Code: (1) a
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`certificate of incorporation as a domestic corporation, under file number 5197177; and (2) a
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`statement naming “National Registered Agents, Inc.” located at 1209 Orange Street,
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`Wilmington, Delaware, 19801, as its registered agent to accept service of process in the State of
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`Delaware.
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`9.
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`On information and belief, Defendant developed the proposed generic product
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`that is the subject of the ticagrelor ANDA to seek regulatory approval from FDA to market and
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`sell the proposed ANDA product throughout the United States, including within Delaware.
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`10.
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`On information and belief, and consistent with its practice with respect to other
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`generic products, following FDA approval of the ticagrelor ANDA, Defendant will distribute and
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`sell the generic product described in the ticagrelor ANDA throughout the United States and
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`within Delaware.
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`JURISDICTION AND VENUE
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`11.
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`Each of the preceding paragraphs 1 to 10 is re-alleged and re-incorporated as if
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`fully set forth herein.
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`12.
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`This action arises under the patent laws of the United States, 35 U.S.C. §§ 100, et
`
`seq., and this Court has jurisdiction over the subject matter of this action under 28 U.S.C.
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`§§ 1331, 1338(a), 2201, and 2202.
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`13.
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`14.
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`Venue is proper in this Court under 28 U.S.C. §§ 1391 and 1400(b).
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`On information and belief, venue is proper in the District of Delaware for
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`Alembic India because it is an Indian corporation “not resident in the United States” that
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`accordingly “may be sued in any judicial district” for venue purposes. 28 U.S.C. § 1391(c)(3);
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`see also In re HTC Corp., 889 F.3d 1349, 1354 (Fed. Cir. 2018) (reaffirming the “long-
`
`established rule that suits against aliens are wholly outside the operation of all the federal venue
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`laws, general and special” (quoting Brunette Mach. Works, Ltd. v. Kockum Indus., Inc., 406 U.S.
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`706, 714 (1972))).
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`15.
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`On information and belief, venue is proper in the District of Delaware for
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`Alembic USA because it is incorporated in Delaware, and thus the District of Delaware is the
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`judicial district “where the defendant resides.” 28 U.S.C. § 1400(b); see also TC Heartland LLC
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`v. Kraft Foods Grp. Brands LLC, 581 U.S. ____, 137 S. Ct. 1514, 1521 (2017) (“[a]s applied to
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`domestic corporations, ‘reside[nce]’ in § 1400(b) refers only to the State of incorporation”).
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`16.
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`Alembic India is subject to specific personal jurisdiction in this District based on
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`the filing of its ticagrelor ANDA with a Paragraph IV certification regarding the ’065 patent.
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`See Acorda Therapeutics Inc. v. Mylan Pharm. Inc., 817 F.3d 755, 762-63 (Fed. Cir. 2016).
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`17.
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`As in Acorda, Alembic India “has taken the costly, significant step of applying to
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`the FDA for approval to engage in future activities—including the marketing of its generic
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`drugs—that will be purposefully directed at,” on information and belief, this District and
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`elsewhere. Acorda Therapeutics, 817 F.3d at 759.
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`18.
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`Alembic India’s “ANDA filings constitute formal acts that reliably indicate plans
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`to engage in marketing of the proposed generic drugs.” Acorda Therapeutics, 817 F.3d at 760.
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`19.
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`As in Acorda, on information and belief Alembic India, alone and/or in concert
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`with its agent, Alembic USA, “intends to direct sales of its drugs” into this District, among other
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`places, “once it has the requested FDA approval to market them.” Acorda Therapeutics, 817 F.3d
`
`at 758.
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`20.
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`On information and belief, Alembic India, alone and/or in concert with its agent,
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`Alembic USA, will engage in marketing of its proposed ticagrelor ANDA product in Delaware,
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`upon approval of its ticagrelor ANDA.
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`21.
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`Alembic India’s ANDA filing, including its Paragraph IV certifications regarding
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`the ’934 and ’065 patents at issue here, is suit-related and has a substantial connection with this
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`District because it reliably, non-speculatively predicts activities in this District by Defendant.
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`22.
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`“[T]he minimum-contacts standard is satisfied by the particular actions
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`[Defendant] has already taken—its ANDA filing[]—for the purpose of engaging in that injury-
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`causing and allegedly wrongful marketing conduct” in this District. Acorda Therapeutics, 817
`
`F.3d at 760.
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`23.
`
`On information and belief, Alembic India and Alembic USA hold themselves out
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`as a unitary entity for purposes of manufacturing, marketing, selling, and distributing generic
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`products.
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`24.
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`On information and belief, Alembic India and Alembic USA work in concert with
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`each other with respect to the regulatory approval, manufacturing, marketing, sale, and
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`distribution of generic pharmaceutical products in the District of Delaware and throughout the
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`United States.
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`25.
`
`On information and belief, Alembic India and Alembic USA acted in concert to
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`develop the proposed generic product that is the subject of the ticagrelor ANDA to seek
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`regulatory approval from FDA to market and sell the proposed ANDA product in the District of
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`Delaware and throughout the United States.
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`26.
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`On information and belief, Alembic India and Alembic USA work in concert with
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`each other with respect to the regulatory approval, manufacturing, marketing, sale, and
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`distribution of generic pharmaceutical products in the District of Delaware and throughout the
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`United States.
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`27.
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`In the Notice Letter, Defendant notified AstraZeneca Pharmaceuticals LP that it
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`had submitted its ticagrelor ANDA to the FDA under Section 505(j) of the Federal Food, Drug,
`
`and Cosmetic Act (21 U.S.C. § 355(j)). The Notice Letter states that it “is provided by Alembic,
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`by and through the undersigned authorized representative, to whom any inquiry, reply or other
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`correspondence should be addressed.” The Notice Letter was sent by Alembic to AstraZeneca
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`Pharmaceuticals LP in the United States, specifically in this District.
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`28.
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`On information and belief, the preparation and submission of the ticagrelor
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`ANDA by Alembic India was done at the direction, under the control, in concert with, and/or for
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`the direct benefit of Alembic USA.
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`29.
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`Further, on information and belief, Alembic India and Alembic USA will
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`manufacture, market, and/or sell within the United States the generic product described in the
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`ticagrelor ANDA if FDA approval is granted. If the ticagrelor ANDA is approved, on
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`information and belief the generic product would, among other things, be marketed and
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`distributed in Delaware, prescribed by physicians practicing in Delaware, and dispensed by
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`pharmacies located within Delaware, and/or used by patients in Delaware, all of which would
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`have a substantial effect on Delaware.
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`30.
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`Furthermore, Alembic India and Alembic USA have both previously been sued in
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`this judicial district without objecting on the basis of lack of personal jurisdiction and have
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`availed themselves of Delaware courts through the assertion of counterclaims. See, e.g., Amgen
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`Inc. et al. v. Alembic Pharm. Ltd. et al., C.A. No. 21-61-CFC; Otsuka Pharm. Co., Ltd. et al. v.
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`Alembic Pharm. Ltd. et al., C.A. No. 20-1365-LPS; AbbVie Inc. et al. v. Alembic Pharm. Ltd. et
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`al., C.A. No. 20-1009-LPS; AstraZeneca AB et al. v. Alembic Pharm. Ltd. et al., C.A. No. 20-
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`202-RGA; Novartis Pharm. Corp. v. Alembic Pharm. Ltd. et al., C.A. No. 20-74-LPS; Otsuka
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`Pharm. Co., Ltd. et al. v. Alembic Pharm. Ltd. et al., C.A. No. 19-2007-LPS; CyDex Pharm., Inc.
`
`v. Alembic Global Holding SA et al., C.A. No. 19-956-LPS; Genentech, Inc. et al. v. Alembic
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`Pharm., Ltd. et al., C.A. No. 19-177-RGA; Boehringer Ingelheim Pharm. Inc. et al. v. Alembic
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`Pharm. Ltd. et al., C.A. No. 18-1762-CFC; H. Lundbeck A/S et al. v. Alembic Pharm. Ltd. et al.,
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`C.A. No. 18-113-LPS; Wyeth LLC et al. v. Alembic Pharm. Ltd. et al., C.A. No. 16-1305-RGA;
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`Bayer Pharma AG et al. v. Alembic Pharm. Ltd. et al., C.A. No. 15-832-GMS; Sanofi et al. v.
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`Alembic Pharm. Ltd., C.A. No. 14-424-RGA; Teijin Ltd. et al. v. Alembic Pharm. Ltd., 13-1939-
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`SLR; Pfizer Inc. et al. v. Alembic Ltd. et al., 11-1213-GMS.
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`31.
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`Alembic India and Alembic USA have also availed themselves of Delaware
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`courts by filing cases in this District as plaintiffs. See, e.g., Alembic Pharm. Ltd. et al. v.
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`GlaxoSmithKline LLC et al., C.A. No. 18-1513-RGA.
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`32.
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`This Court also has personal jurisdiction over Alembic India and Alembic USA
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`because, inter alia, Alembic India and Alembic USA have purposefully availed themselves of
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`the rights and benefits of Delaware law by engaging in systematic and continuous contacts with
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`the State of Delaware. On information and belief, Alembic India and Alembic USA regularly
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`and continuously transact business within the state of Delaware, including by selling
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`pharmaceutical products in Delaware, directly and/or through affiliates, and/or by continuously
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`and systematically placing goods into the stream of commerce for distribution throughout the
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`United States, including Delaware. On information and belief, Alembic India and Alembic USA
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`derive substantial revenue from the sale of those products in Delaware and have availed
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`themselves of the privilege of conducting business within the State of Delaware.
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`33.
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`For example, on information and belief, on August 10, 2012, Alembic USA was
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`incorporated in the State of Delaware as a “domestic” corporation under file number 5197177.
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`34.
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`For these reasons and for other reasons that will be presented to the Court if
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`jurisdiction is challenged, the Court has personal jurisdiction over Alembic India and Alembic
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`USA.
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`PATENTS-IN-SUIT
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`35.
`
`On April 23, 2013, the U.S. Patent and Trademark Office duly and legally issued
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`the ’934 patent, entitled “Pharmaceutical compositions.” A true and correct copy of the ’934
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`patent is attached hereto as Exhibit A. The claims of the ’934 patent are valid and enforceable.
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`AstraZeneca AB is the owner of the ’934 patent by assignment and has the right to enforce it.
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`36.
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`On May 28, 2019, the U.S. Patent and Trademark Office duly and legally issued
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`the ’065 patent, entitled “Method of treating or prevention of atherothrombotic events in
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`patients with history of myocardial infarction.” A true and correct copy of the ’065 patent is
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`attached hereto as Exhibit B. The claims of the ’065 patent are valid and enforceable.
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`AstraZeneca AB is the owner of the ’065 patent by assignment and has the right to enforce it.
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`37.
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`AstraZeneca Pharmaceuticals LP is the holder of NDA No. 022433 by which
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`FDA granted approval for the marketing and sale of ticagrelor tablets in 90 mg and 60 mg
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`dosage strengths, to reduce the rate of cardiovascular death, myocardial infarction, and stroke in
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`patients with acute coronary syndrome (ACS) or a history of myocardial infarction (MI), to
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`reduce the risk of stent thrombosis in patients who have been stented for treatment of ACS, and
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`to reduce the risk of a first MI or stroke in patients with coronary artery disease (CAD) at high
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`risk for such events. AstraZeneca markets ticagrelor tablets in the United States, through
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`AstraZeneca Pharmaceuticals LP, under the trade name “BRILINTA®.” FDA’s official
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`publication of approved drugs, the Orange Book, includes BRILINTA® in 90 mg and 60 mg
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`dosage strengths together with Orange Book-listed patents protecting BRILINTA® and its use,
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`including the ’934 and ’065 patents.
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`INFRINGEMENT BY DEFENDANT
`
`38.
`
`Each of the preceding paragraphs 1 to 37 is re-alleged and re-incorporated as if
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`fully set forth herein.
`
`39.
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`In the Notice Letter, Alembic notified AstraZeneca Pharmaceuticals LP that it had
`
`submitted its ticagrelor ANDA to the FDA under Section 505(j) of the Federal Food, Drug, and
`
`Cosmetic Act (21 U.S.C. § 355(j)).
`
`40.
`
`The Notice Letter states that Alembic is seeking approval from FDA to engage in
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`the commercial manufacture, use, and sale of generic ticagrelor tablets before the expiration of,
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`inter alia, the ’934 and ’065 patents. On information and belief, Alembic intends to engage in
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`the commercial manufacture, use, and sale of its generic ticagrelor tablets after receiving FDA
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`approval to do so.
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`41.
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`In the Notice Letter, Alembic notified AstraZeneca that its ANDA contained a
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`“Paragraph IV certification” asserting that the ’934 and ’065 patents are invalid, unenforceable,
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`and/or will not be infringed by the commercial manufacture, use, and sale of Alembic’s generic
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`ticagrelor tablets.
`
`42.
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`This Complaint is being filed before the expiration of the forty-five days from the
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`date AstraZeneca received the Notice Letter.
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`COUNT I (INFRINGEMENT OF THE ’934 PATENT)
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`43.
`
`Each of the preceding paragraphs 1 to 42 is re-alleged and re-incorporated as if
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`fully set forth herein.
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`44.
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`Defendant’s submission of its ticagrelor ANDA to obtain approval to engage in the
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`commercial manufacture, use, offer to sell, or sale of generic ticagrelor tablets prior to the
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`expiration of the ’934 patent constituted an act of infringement under 35 U.S.C. § 271(e)(2)(A).
`
`45.
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`On information and belief, upon FDA approval of Defendant’s ticagrelor ANDA,
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`Defendant will further infringe at least claim 1 of the ’934 patent by making, using, offering to
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`sell, and selling its generic ticagrelor tablets in the United States and/or importing such tablets into
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`the United States in violation of 35 U.S.C. §§ 271(a), 271(b), and/or 271(c) unless enjoined by the
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`Court.
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`46.
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`If Defendant’s marketing and sale of generic ticagrelor tablets prior to expiration
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`of the ’934 patent and all other relevant exclusivities is not enjoined, AstraZeneca will suffer
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`substantial and irreparable harm for which there is no remedy at law.
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`COUNT II (INFRINGEMENT OF THE ’065 PATENT)
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`47.
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`Each of the preceding paragraphs 1 to 46 is re-alleged and re-incorporated as if
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`fully set forth herein.
`
`48.
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`Defendant’s submission of its ticagrelor ANDA to obtain approval to engage in the
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`commercial manufacture, use, offer to sell, or sale of generic ticagrelor tablets prior to the
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`expiration of the ’065 patent constituted an act of infringement under 35 U.S.C. § 271(e)(2)(A).
`
`49.
`
`On information and belief, upon FDA approval of Defendant’s ticagrelor ANDA,
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`Defendant will further infringe at least claim 1 of the ’065 patent by making, using, offering to
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`sell, and selling its generic ticagrelor tablets in the United States and/or importing such tablets into
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`the United States in violation of 35 U.S.C. §§ 271(a), 271(b), and/or 271(c) unless enjoined by the
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`Court.
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`50.
`
`Defendant, in its Notice Letter, provides no factual basis for contending that its
`
`ticagrelor ANDA product will not infringe the claims of the ’065 patent under 35 U.S.C. §§ 271(a),
`
`271(b), or 271(c), and does not deny that its ticagrelor ANDA product will infringe claims of the
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`’065 patent under 35 U.S.C. §§ 271(a), 271(b), or 271(c).
`
`51.
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`If Defendant’s marketing and sale of generic ticagrelor tablets prior to expiration
`
`of the ’065 patent and all other relevant exclusivities is not enjoined, AstraZeneca will suffer
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`substantial and irreparable harm for which there is no remedy at law.
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`PRAYER FOR RELIEF
`
`WHEREFORE, AstraZeneca respectfully prays that this Court grant the following relief:
`
`1.
`
`A judgment that the claims of the ’934 patent are not invalid, not unenforceable,
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`and are infringed by Defendant’s submission of its ticagrelor ANDA, and that Defendant’s making,
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`using, offering to sell, or selling in the United States, or importing into the United States
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`Defendant’s generic ticagrelor tablets will infringe the ’934 patent.
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`2.
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`A judgment that the claims of the ’065 patent are not invalid, not unenforceable,
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`and are infringed by Defendant’s submission of its ticagrelor ANDA, and that Defendant’s making,
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`using, offering to sell, or selling in the United States, or importing into the United States
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`Defendant’s generic ticagrelor tablets will infringe the ’065 patent.
`
`3.
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`An order pursuant to 35 U.S.C. § 271(e)(4)(A) providing that the effective date of
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`any approval of Defendant’s ticagrelor ANDA shall be a date which is not earlier than the latest
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`expiration date of the ’934 and ’065 patents, including any extensions and/or additional periods of
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`exclusivity to which AstraZeneca is or becomes entitled.
`
`4.
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`An order permanently enjoining Defendant, its affiliates, subsidiaries, and each of
`
`its officers, agents, servants and employees, and those acting in privity or concert with them, from
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`making, using, offering to sell, or selling in the United States, or importing into the United States
`
`Defendant’s generic ticagrelor tablets until after the latest expiration date of the ’934 and ’065
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`patents, including any extensions and/or additional periods of exclusivity to which AstraZeneca is
`
`or becomes entitled.
`
`5.
`
`Damages or other monetary relief to AstraZeneca if Defendant engages in
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`commercial manufacture, use, offers to sell, sale, or importation in or into the United States of
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`Defendant’s generic ticagrelor tablets prior to the latest expiration date of the ’934 and ’065
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`patents, including any extensions and/or additional periods of exclusivity to which AstraZeneca is
`
`or becomes entitled.
`
`6.
`
`Such further and other relief as this Court deems proper and just, including any
`
`appropriate relief under 35 U.S.C. § 285.
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`DATED: June 18, 2021
`
`MCCARTER & ENGLISH, LLP
`
`/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
`
`OF COUNSEL:
`
`Charles E. Lipsey
`Ryan P. O'Quinn
`FINNEGAN, HENDERSON, FARABOW,
`GARRETT & DUNNER, L.L.P.
`1875 Explorer Street, Suite 800
`Reston, VA 20190
`(571) 203-2700
`(202) 408-4400 (fax)
`Charles.Lipsey@finnegan.com
`oquinnr@finnegan.com
`
`Mark J. Feldstein
`Jill K. MacAlpine
`FINNEGAN, HENDERSON, FARABOW,
`GARRETT & DUNNER, L.L.P.
`901 New York Ave., N.W.
`Washington, D.C. 20001
`(202) 408-4000
`Mark.Feldstein@finnegan.com
`Jill.MacAlpine@finnegan.com
`
`ME1 36788519v.1
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