throbber
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:
`
`NATURE OF THE ACTION
`
`1.
`
`This is an action for patent infringement arising under the patent laws of the
`
`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
`
`(“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®
`
`(ticagrelor) drug product prior to expiration of AstraZeneca’s U.S. Patent Nos. 8,425,934 (“the
`
`’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
`
`Book”) for BRILINTA®.
`
`PARTIES
`
`2.
`
`AstraZeneca is engaged in the business of creating, developing, and bringing to
`
`market revolutionary biopharmaceutical products to help patients prevail against serious
`
`diseases, including treatments for cardiovascular diseases.
`
`3.
`
`Plaintiff AstraZeneca AB is a company operating and existing under the laws of
`
`Sweden, with its principal place of business at SE-151 85 Södertälje, Sweden. AstraZeneca AB
`
`is the owner of the ’934 and ’065 patents.
`
`4.
`
`Plaintiff AstraZeneca Pharmaceuticals LP is a limited partnership operating and
`
`existing under the laws of Delaware, with its principal place of business at One MedImmune
`
`Way, Gaithersburg, Maryland 20878. AstraZeneca Pharmaceuticals LP is the holder of New
`
`Drug Application (“NDA”) No. 022433 for BRILINTA® (ticagrelor). AstraZeneca
`
`Pharmaceuticals LP markets and sells BRILINTA® in this judicial district and throughout the
`
`United States. Defendant specifically directed a letter dated May 7, 2021 with the heading “Re:
`
`Notification of Certification Under 21 U.S.C. § 355(j)(2)(B) of the Federal Food, Drug &
`
`Cosmetic Act, and Under 21 C.F.R. § 314.95 Alembic Pharmaceuticals Ltd. – Ticagrelor Tablet
`
`60 mg ANDA No. 208576” (“Notice Letter”) to AstraZeneca Pharmaceuticals LP.
`
`5.
`
`On information and belief, Alembic India is a corporation organized and existing
`
`under the laws of India, having a principal place of business at Alembic Road, Vadodara 390003,
`
`Gujarat, India. On information and belief, Alembic India, itself and through its affiliates and
`
`subsidiaries, including Alembic USA, formulates, manufactures, packages, and markets generic
`
`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
`
`under the laws of the State of Delaware, having a principal place of business at 750 Highway
`
`202, Bridgewater, New Jersey 08807. On information and belief, Alembic USA is a wholly-
`
`owned subsidiary and U.S. agent of Alembic India.
`
`7.
`
`On information and belief, Alembic USA is a pharmaceutical company that
`
`formulates, manufactures, packages, and markets generic drug products for distribution in the
`
`District of Delaware and throughout the United States.
`
`8.
`
`On information and belief, Alembic USA is qualified to do business in Delaware
`
`and appointed a registered agent for service of process, by filing with the Secretary of State on
`
`August 10, 2012 pursuant to sections 371 and 376 of title 8 of the Delaware Code: (1) a
`
`certificate of incorporation as a domestic corporation, under file number 5197177; and (2) a
`
`statement naming “National Registered Agents, Inc.” located at 1209 Orange Street,
`
`Wilmington, Delaware, 19801, as its registered agent to accept service of process in the State of
`
`Delaware.
`
`9.
`
`On information and belief, Defendant developed the proposed generic product
`
`that is the subject of the ticagrelor ANDA to seek regulatory approval from FDA to market and
`
`sell the proposed ANDA product throughout the United States, including within Delaware.
`
`10.
`
`On information and belief, and consistent with its practice with respect to other
`
`generic products, following FDA approval of the ticagrelor ANDA, Defendant will distribute and
`
`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.
`
`Each of the preceding paragraphs 1 to 10 is re-alleged and re-incorporated as if
`
`fully set forth herein.
`
`12.
`
`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.
`
`§§ 1331, 1338(a), 2201, and 2202.
`
`13.
`
`14.
`
`Venue is proper in this Court under 28 U.S.C. §§ 1391 and 1400(b).
`
`On information and belief, venue is proper in the District of Delaware for
`
`Alembic India because it is an Indian corporation “not resident in the United States” that
`
`accordingly “may be sued in any judicial district” for venue purposes. 28 U.S.C. § 1391(c)(3);
`
`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
`
`laws, general and special” (quoting Brunette Mach. Works, Ltd. v. Kockum Indus., Inc., 406 U.S.
`
`706, 714 (1972))).
`
`15.
`
`On information and belief, venue is proper in the District of Delaware for
`
`Alembic USA because it is incorporated in Delaware, and thus the District of Delaware is the
`
`judicial district “where the defendant resides.” 28 U.S.C. § 1400(b); see also TC Heartland LLC
`
`v. Kraft Foods Grp. Brands LLC, 581 U.S. ____, 137 S. Ct. 1514, 1521 (2017) (“[a]s applied to
`
`domestic corporations, ‘reside[nce]’ in § 1400(b) refers only to the State of incorporation”).
`
`16.
`
`Alembic India is subject to specific personal jurisdiction in this District based on
`
`the filing of its ticagrelor ANDA with a Paragraph IV certification regarding the ’065 patent.
`
`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
`
`the FDA for approval to engage in future activities—including the marketing of its generic
`
`drugs—that will be purposefully directed at,” on information and belief, this District and
`
`elsewhere. Acorda Therapeutics, 817 F.3d at 759.
`
`18.
`
`Alembic India’s “ANDA filings constitute formal acts that reliably indicate plans
`
`to engage in marketing of the proposed generic drugs.” Acorda Therapeutics, 817 F.3d at 760.
`
`19.
`
`As in Acorda, on information and belief Alembic India, alone and/or in concert
`
`with its agent, Alembic USA, “intends to direct sales of its drugs” into this District, among other
`
`places, “once it has the requested FDA approval to market them.” Acorda Therapeutics, 817 F.3d
`
`at 758.
`
`20.
`
`On information and belief, Alembic India, alone and/or in concert with its agent,
`
`Alembic USA, will engage in marketing of its proposed ticagrelor ANDA product in Delaware,
`
`upon approval of its ticagrelor ANDA.
`
`21.
`
`Alembic India’s ANDA filing, including its Paragraph IV certifications regarding
`
`the ’934 and ’065 patents at issue here, is suit-related and has a substantial connection with this
`
`District because it reliably, non-speculatively predicts activities in this District by Defendant.
`
`22.
`
`“[T]he minimum-contacts standard is satisfied by the particular actions
`
`[Defendant] has already taken—its ANDA filing[]—for the purpose of engaging in that injury-
`
`causing and allegedly wrongful marketing conduct” in this District. Acorda Therapeutics, 817
`
`F.3d at 760.
`
`23.
`
`On information and belief, Alembic India and Alembic USA hold themselves out
`
`as a unitary entity for purposes of manufacturing, marketing, selling, and distributing generic
`
`products.
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`24.
`
`On information and belief, Alembic India and Alembic USA work in concert with
`
`each other with respect to the regulatory approval, manufacturing, marketing, sale, and
`
`distribution of generic pharmaceutical products in the District of Delaware and throughout the
`
`United States.
`
`25.
`
`On information and belief, Alembic India and Alembic USA acted in concert to
`
`develop the proposed generic product that is the subject of the ticagrelor ANDA to seek
`
`regulatory approval from FDA to market and sell the proposed ANDA product in the District of
`
`Delaware and throughout the United States.
`
`26.
`
`On information and belief, Alembic India and Alembic USA work in concert with
`
`each other with respect to the regulatory approval, manufacturing, marketing, sale, and
`
`distribution of generic pharmaceutical products in the District of Delaware and throughout the
`
`United States.
`
`27.
`
`In the Notice Letter, Defendant 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)). The Notice Letter states that it “is provided by Alembic,
`
`by and through the undersigned authorized representative, to whom any inquiry, reply or other
`
`correspondence should be addressed.” The Notice Letter was sent by Alembic to AstraZeneca
`
`Pharmaceuticals LP in the United States, specifically in this District.
`
`28.
`
`On information and belief, the preparation and submission of the ticagrelor
`
`ANDA by Alembic India was done at the direction, under the control, in concert with, and/or for
`
`the direct benefit of Alembic USA.
`
`29.
`
`Further, on information and belief, Alembic India and Alembic USA will
`
`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
`
`information and belief the generic product would, among other things, be marketed and
`
`distributed in Delaware, prescribed by physicians practicing in Delaware, and dispensed by
`
`pharmacies located within Delaware, and/or used by patients in Delaware, all of which would
`
`have a substantial effect on Delaware.
`
`30.
`
`Furthermore, Alembic India and Alembic USA have both previously been sued in
`
`this judicial district without objecting on the basis of lack of personal jurisdiction and have
`
`availed themselves of Delaware courts through the assertion of counterclaims. See, e.g., Amgen
`
`Inc. et al. v. Alembic Pharm. Ltd. et al., C.A. No. 21-61-CFC; Otsuka Pharm. Co., Ltd. et al. v.
`
`Alembic Pharm. Ltd. et al., C.A. No. 20-1365-LPS; AbbVie Inc. et al. v. Alembic Pharm. Ltd. et
`
`al., C.A. No. 20-1009-LPS; AstraZeneca AB et al. v. Alembic Pharm. Ltd. et al., C.A. No. 20-
`
`202-RGA; Novartis Pharm. Corp. v. Alembic Pharm. Ltd. et al., C.A. No. 20-74-LPS; Otsuka
`
`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
`
`Pharm., Ltd. et al., C.A. No. 19-177-RGA; Boehringer Ingelheim Pharm. Inc. et al. v. Alembic
`
`Pharm. Ltd. et al., C.A. No. 18-1762-CFC; H. Lundbeck A/S et al. v. Alembic Pharm. Ltd. et al.,
`
`C.A. No. 18-113-LPS; Wyeth LLC et al. v. Alembic Pharm. Ltd. et al., C.A. No. 16-1305-RGA;
`
`Bayer Pharma AG et al. v. Alembic Pharm. Ltd. et al., C.A. No. 15-832-GMS; Sanofi et al. v.
`
`Alembic Pharm. Ltd., C.A. No. 14-424-RGA; Teijin Ltd. et al. v. Alembic Pharm. Ltd., 13-1939-
`
`SLR; Pfizer Inc. et al. v. Alembic Ltd. et al., 11-1213-GMS.
`
`31.
`
`Alembic India and Alembic USA have also availed themselves of Delaware
`
`courts by filing cases in this District as plaintiffs. See, e.g., Alembic Pharm. Ltd. et al. v.
`
`GlaxoSmithKline LLC et al., C.A. No. 18-1513-RGA.
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`32.
`
`This Court also has personal jurisdiction over Alembic India and Alembic USA
`
`because, inter alia, Alembic India and Alembic USA have purposefully availed themselves of
`
`the rights and benefits of Delaware law by engaging in systematic and continuous contacts with
`
`the State of Delaware. On information and belief, Alembic India and Alembic USA regularly
`
`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
`
`and systematically placing goods into the stream of commerce for distribution throughout the
`
`United States, including Delaware. On information and belief, Alembic India and Alembic USA
`
`derive substantial revenue from the sale of those products in Delaware and have availed
`
`themselves of the privilege of conducting business within the State of Delaware.
`
`33.
`
`For example, on information and belief, on August 10, 2012, Alembic USA was
`
`incorporated in the State of Delaware as a “domestic” corporation under file number 5197177.
`
`34.
`
`For these reasons and for other reasons that will be presented to the Court if
`
`jurisdiction is challenged, the Court has personal jurisdiction over Alembic India and Alembic
`
`USA.
`
`PATENTS-IN-SUIT
`
`35.
`
`On April 23, 2013, the U.S. Patent and Trademark Office duly and legally issued
`
`the ’934 patent, entitled “Pharmaceutical compositions.” A true and correct copy of the ’934
`
`patent is attached hereto as Exhibit A. The claims of the ’934 patent are valid and enforceable.
`
`AstraZeneca AB is the owner of the ’934 patent by assignment and has the right to enforce it.
`
`36.
`
`On May 28, 2019, the U.S. Patent and Trademark Office duly and legally issued
`
`the ’065 patent, entitled “Method of treating or prevention of atherothrombotic events in
`
`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.
`
`AstraZeneca AB is the owner of the ’065 patent by assignment and has the right to enforce it.
`
`37.
`
`AstraZeneca Pharmaceuticals LP is the holder of NDA No. 022433 by which
`
`FDA granted approval for the marketing and sale of ticagrelor tablets in 90 mg and 60 mg
`
`dosage strengths, to reduce the rate of cardiovascular death, myocardial infarction, and stroke in
`
`patients with acute coronary syndrome (ACS) or a history of myocardial infarction (MI), to
`
`reduce the risk of stent thrombosis in patients who have been stented for treatment of ACS, and
`
`to reduce the risk of a first MI or stroke in patients with coronary artery disease (CAD) at high
`
`risk for such events. AstraZeneca markets ticagrelor tablets in the United States, through
`
`AstraZeneca Pharmaceuticals LP, under the trade name “BRILINTA®.” FDA’s official
`
`publication of approved drugs, the Orange Book, includes BRILINTA® in 90 mg and 60 mg
`
`dosage strengths together with Orange Book-listed patents protecting BRILINTA® and its use,
`
`including the ’934 and ’065 patents.
`
`INFRINGEMENT BY DEFENDANT
`
`38.
`
`Each of the preceding paragraphs 1 to 37 is re-alleged and re-incorporated as if
`
`fully set forth herein.
`
`39.
`
`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
`
`the commercial manufacture, use, and sale of generic ticagrelor tablets before the expiration of,
`
`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
`
`approval to do so.
`
`41.
`
`In the Notice Letter, Alembic notified AstraZeneca that its ANDA contained a
`
`“Paragraph IV certification” asserting that the ’934 and ’065 patents are invalid, unenforceable,
`
`and/or will not be infringed by the commercial manufacture, use, and sale of Alembic’s generic
`
`ticagrelor tablets.
`
`42.
`
`This Complaint is being filed before the expiration of the forty-five days from the
`
`date AstraZeneca received the Notice Letter.
`
`COUNT I (INFRINGEMENT OF THE ’934 PATENT)
`
`43.
`
`Each of the preceding paragraphs 1 to 42 is re-alleged and re-incorporated as if
`
`fully set forth herein.
`
`44.
`
`Defendant’s submission of its ticagrelor ANDA to obtain approval to engage in the
`
`commercial manufacture, use, offer to sell, or sale of generic ticagrelor tablets prior to the
`
`expiration of the ’934 patent constituted an act of infringement under 35 U.S.C. § 271(e)(2)(A).
`
`45.
`
`On information and belief, upon FDA approval of Defendant’s ticagrelor ANDA,
`
`Defendant will further infringe at least claim 1 of the ’934 patent by making, using, offering to
`
`sell, and selling its generic ticagrelor tablets in the United States and/or importing such tablets into
`
`the United States in violation of 35 U.S.C. §§ 271(a), 271(b), and/or 271(c) unless enjoined by the
`
`Court.
`
`46.
`
`If Defendant’s marketing and sale of generic ticagrelor tablets prior to expiration
`
`of the ’934 patent and all other relevant exclusivities is not enjoined, AstraZeneca will suffer
`
`substantial and irreparable harm for which there is no remedy at law.
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`COUNT II (INFRINGEMENT OF THE ’065 PATENT)
`
`47.
`
`Each of the preceding paragraphs 1 to 46 is re-alleged and re-incorporated as if
`
`fully set forth herein.
`
`48.
`
`Defendant’s submission of its ticagrelor ANDA to obtain approval to engage in the
`
`commercial manufacture, use, offer to sell, or sale of generic ticagrelor tablets prior to the
`
`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,
`
`Defendant will further infringe at least claim 1 of the ’065 patent by making, using, offering to
`
`sell, and selling its generic ticagrelor tablets in the United States and/or importing such tablets into
`
`the United States in violation of 35 U.S.C. §§ 271(a), 271(b), and/or 271(c) unless enjoined by the
`
`Court.
`
`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
`
`’065 patent under 35 U.S.C. §§ 271(a), 271(b), or 271(c).
`
`51.
`
`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
`
`substantial and irreparable harm for which there is no remedy at law.
`
`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,
`
`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
`
`Defendant’s generic ticagrelor tablets will infringe the ’934 patent.
`
`2.
`
`A judgment that the claims of the ’065 patent are not invalid, not unenforceable,
`
`and are infringed by Defendant’s submission of its ticagrelor ANDA, and that Defendant’s making,
`
`using, offering to sell, or selling in the United States, or importing into the United States
`
`Defendant’s generic ticagrelor tablets will infringe the ’065 patent.
`
`3.
`
`An order pursuant to 35 U.S.C. § 271(e)(4)(A) providing that the effective date of
`
`any approval of Defendant’s ticagrelor ANDA shall be a date which is not earlier than the latest
`
`expiration date of the ’934 and ’065 patents, including any extensions and/or additional periods of
`
`exclusivity to which AstraZeneca is or becomes entitled.
`
`4.
`
`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
`
`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
`
`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
`
`commercial manufacture, use, offers to sell, sale, or importation in or into the United States of
`
`Defendant’s generic ticagrelor tablets prior to the latest expiration date of the ’934 and ’065
`
`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
`
`- 13 -
`
`

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