Case 1:22-cv-00155-UNA Document 1 Filed 02/02/22 Page 1 of 28 PageID #: 1
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`
`ACERTA PHARMA B.V., ASTRAZENECA
`UK LIMITED, ASTRAZENECA
`PHARMACEUTICALS LP,
`ASTRAZENECA AB, and MERCK SHARP
`& DOHME B.V.,
`
`Plaintiffs,
`
`v.
`
`NATCO PHARMA LIMITED and NATCO
`PHARMA, INC.,
`
`Defendants.
`
`Civil Action No. ____________
`
`COMPLAINT
`
`Plaintiffs Acerta Pharma B.V., AstraZeneca UK Limited, AstraZeneca Pharmaceuticals
`
`LP, AstraZeneca AB (collectively “AstraZeneca”), and Merck Sharp & Dohme B.V. (“Merck”)
`
`(together hereinafter “Plaintiffs”) file this Complaint for patent infringement against Natco Pharma
`
`Limited and Natco Pharma, Inc. (collectively, “Natco”), and by their attorneys, hereby allege as
`
`follows:
`
`1.
`
`This is an action for patent infringement under the patent laws of the United States,
`
`35 U.S.C. §§ 100 et seq., which arises out of the submission by Natco of Abbreviated New Drug
`
`New Drug Application (“ANDA”) No. 216768 (“Natco’s ANDA”) to the U.S. Food and Drug
`
`Administration (“FDA”) seeking approval to commercially manufacture, use, offer for sale, sell,
`
`and/or import a generic version of CALQUENCE® (acalabrutinib) 100 mg oral capsules prior to
`
`the expiration of U.S. Patent No. 9,290,504 (“the ’504 patent”); U.S. Patent No. 9,758,524 (“the
`
`’524 patent”); U.S. Patent No. 10,239,883 (“the ’883 patent”); U.S. Patent No. 9,796,721 (“the
`1
`
`ME1 39434122v.1
`
`

`

`Case 1:22-cv-00155-UNA Document 1 Filed 02/02/22 Page 2 of 28 PageID #: 2
`
`’721 patent”); U.S. Patent No. 10,167,291 (“the ’291 patent”); and U.S. Patent No. 10,272,083
`
`(“the ’083 patent”). These patents are referred to collectively herein as the “Patents-in-Suit.”
`
`PARTIES
`
`2.
`
`Plaintiff Acerta Pharma B.V. is a private limited liability company organized and
`
`existing under the laws of the Netherlands, having its principal place of business at Kloosterstraat
`
`9, 5349 AB Oss, The Netherlands.
`
`3.
`
`Plaintiff AstraZeneca UK Limited is a private company limited by shares organized
`
`and existing under the laws of England and Wales, having its principal place of business at 1
`
`Francis Crick Avenue, Cambridge Biomedical Campus, Cambridge CB2 0AA, United Kingdom.
`
`AstraZeneca UK Limited is the holder of New Drug Application No. 210259 for the manufacture
`
`and sale of CALQUENCE® (acalabrutinib) which has been approved by the FDA.
`
`4.
`
`Plaintiff AstraZeneca Pharmaceuticals LP is a limited partnership organized and
`
`existing under the laws of the State of Delaware, having its principal place of business at 1800
`
`Concord Pike, P.O. Box 15437, Wilmington, Delaware, 19850.
`
`5.
`
`Plaintiff AstraZeneca AB is a corporation organized and existing under the laws of
`
`Sweden, with its principal place of business at S-151 85 Södertälje, Sweden.
`
`6.
`
`Plaintiff Merck Sharp & Dohme B.V. is a company organized and existing under
`
`the laws of The Netherlands, having its principal place of business at Waarderweg 39, 2031BN
`
`Haarlem, The Netherlands.
`
`7.
`
`On information and belief, defendant Natco Pharma Limited is a company
`
`organized and existing under the laws of the Republic of India with a principal place of business
`
`at Natco House Road No. 2, Banjara Hills 500 034, Hyderabad, India. On information and belief,
`
`Natco Pharma Limited is in the business of, among other things, manufacturing and selling generic
`
`ME1 39434122v.1
`
`2
`
`

`

`Case 1:22-cv-00155-UNA Document 1 Filed 02/02/22 Page 3 of 28 PageID #: 3
`
`versions of branded pharmaceutical drugs through various operating subsidiaries, including Natco
`
`Pharma, Inc.
`
`8.
`
`On information and belief, defendant Natco Pharma, Inc. is a corporation organized
`
`and existing under the laws of the State of Delaware with a principal place of business at 297 Mine
`
`Bank Rd., Wellsville, PA 17365-9514. On information and belief, Natco Pharma, Inc. is in the
`
`business of, among other things, manufacturing and selling generic versions of branded
`
`pharmaceutical products for the U.S. market.
`
`9.
`
`On information and belief, Natco Pharma, Inc. is a wholly owned subsidiary of
`
`Natco Pharma Limited and is controlled and/or dominated by Natco Pharma Limited.
`
`10.
`
`On information and belief, Natco Pharma Limited and Natco Pharma, Inc. acted in
`
`concert to prepare and submit Natco’s ANDA to the FDA.
`
`11.
`
`On information and belief, Natco Pharma Limited and Natco Pharma, Inc. know
`
`and intend that upon approval of Natco’s ANDA, Natco Pharma Limited will manufacture Natco’s
`
`ANDA Products and Natco Pharma Limited and Natco Pharma, Inc. will directly or indirectly
`
`market, sell, and distribute Natco’s ANDA Products throughout the United States, including in
`
`Delaware.
`
`12.
`
`On information and belief, following any FDA approval of Natco’s ANDA, Natco
`
`Pharma Limited and Natco Pharma, Inc. will act in concert to distribute and sell Natco’s ANDA
`
`Products throughout the United States, including within Delaware.
`
`JURISDICTION
`
`13.
`
`Plaintiffs incorporate each of the preceding paragraphs 1–12 as if fully set forth
`
`herein.
`
`ME1 39434122v.1
`
`3
`
`

`

`Case 1:22-cv-00155-UNA Document 1 Filed 02/02/22 Page 4 of 28 PageID #: 4
`
`14.
`
`This Court has subject matter jurisdiction over this action pursuant to 28 U.S.C. §§
`
`1331, 1338(a), 2201, and 2202.
`
`15.
`
`Based on the facts and causes alleged herein, and for additional reasons to be further
`
`developed through discovery if necessary, this Court has personal jurisdiction over Natco.
`
`16.
`
`Natco Pharma Limited is subject to personal jurisdiction in Delaware because,
`
`among other things, Natco Pharma Limited, itself and through its wholly-owned subsidiary Natco
`
`Pharma Inc., has purposefully availed itself of the benefits and protections of Delaware’s laws
`
`such that it should reasonably anticipate being haled into court here. On information and belief,
`
`Natco Pharma Limited itself, and through its wholly-owned subsidiary Natco Pharma, Inc.,
`
`develops, manufactures, imports, markets, offers to sell, and/or sells generic drugs throughout the
`
`United States, including in the State of Delaware, and therefore transacts business within the State
`
`of Delaware related to Plaintiffs’ claims, and/or has engaged in systematic and continuous business
`
`contacts within the State of Delaware. In addition, Natco Pharma Limited is subject to personal
`
`jurisdiction in Delaware because, on information and belief, it controls and dominates Natco
`
`Pharma, Inc. and therefore the activities of Natco Pharma, Inc. in this jurisdiction are attributed to
`
`Natco Pharma Limited.
`
`17.
`
`Natco Pharma, Inc. is subject to personal jurisdiction in Delaware because, among
`
`other things, it has purposely availed itself of the benefits and protections of Delaware’s laws such
`
`that it should reasonably anticipate being haled into court here. Natco Pharma, Inc. is a corporation
`
`organized and existing under the laws of the State of Delaware, is qualified to do business in
`
`Delaware, and has appointed a registered agent for service of process in Delaware. It therefore
`
`has consented to general jurisdiction in Delaware. In addition, on information and belief, Natco
`
`Pharma, Inc. develops, manufactures, imports, markets, offers to sell, and/or sells generic drugs
`
`ME1 39434122v.1
`
`4
`
`

`

`Case 1:22-cv-00155-UNA Document 1 Filed 02/02/22 Page 5 of 28 PageID #: 5
`
`throughout the United States, including in the State of Delaware and therefore transacts business
`
`within the State of Delaware related to Plaintiffs’ claims, and/or has engaged in systematic and
`
`continuous business contacts within the State of Delaware.
`
`18.
`
`In addition, this Court has personal jurisdiction over Natco because, among other
`
`things, on information and belief: (1) Natco filed Natco’s ANDA for the purpose of seeking
`
`approval to engage in the commercial manufacture, use, offer for sale, sale, and/or importation of
`
`Natco’s ANDA Product in the United States, including in Delaware; and (2) upon approval of
`
`Natco’s ANDA, Natco will market, distribute, offer for sale, sell, and/or import Natco’s ANDA
`
`Product in the United States, including in Delaware, and will derive substantial revenue from the
`
`use or consumption of Natco’s ANDA Product in Delaware. See Acorda Therapeutics Inc. v.
`
`Mylan Pharm. Inc., 817 F.3d 755, 763 (Fed. Cir. 2016). On information and belief, upon approval
`
`of Natco’s ANDA, Natco’s ANDA Products will, among other things, be marketed, distributed,
`
`offered for sale, sold, and/or imported in Delaware; prescribed by physicians practicing in
`
`Delaware; dispensed by pharmacies located within Delaware; and/or used by patients in Delaware,
`
`all of which would have a substantial effect on Delaware.
`
`19.
`
`In addition, this Court has personal jurisdiction over Natco because Natco Pharma
`
`Limited and Natco Pharma, Inc. regularly (1) engage in patent litigation concerning Natco’s
`
`ANDA products in this District, (2) do not contest personal jurisdiction in this District, and (3)
`
`purposefully avail themselves of the rights and benefits of this Court by asserting claims and/or
`
`counterclaims in this District. See, e.g., Defs.’ Answer, Cephalon, Inc. v. Breckenridge
`
`Pharmaceutical, Inc. et al., No. 1:14-cv-00671 (D. Del. Jul. 7, 2014), D.I. 7; Natco’s Answer to
`
`Second Am. Compl., Gilead Sciences, Inc. v. Apotex, Inc. et al., No. 1:20-cv-00189 (D. Del. Nov.
`
`15, 2021), D.I. 391.
`
`ME1 39434122v.1
`
`5
`
`

`

`Case 1:22-cv-00155-UNA Document 1 Filed 02/02/22 Page 6 of 28 PageID #: 6
`
`20.
`
`For the above reasons, it would not be unfair or unreasonable for Natco to litigate
`
`this action in this District, and the Court has personal jurisdiction over it here.
`
`21.
`
`Plaintiffs incorporate each of the preceding paragraphs 1–20 as if fully set forth
`
`VENUE
`
`herein.
`
`22.
`
`Venue is proper in this District under 28 U.S.C. § 1391 with respect to Natco
`
`Pharma Limited, at least because, on information and belief, Natco Pharma Limited is a foreign
`
`corporation that may be sued in any judicial district in which it is subject to the
`
`Court’s personal jurisdiction.
`
`23.
`
`Venue is proper in this district as to Natco Pharma, Inc. pursuant to 28 U.S.C. §
`
`1400(b) because, inter alia, Natco Pharma, Inc. is a corporation organized and existing under the
`
`laws of the State of Delaware and thus “resides” in this judicial district. TC Heartland LLC v.
`
`Kraft Foods Grp. Brands LLC, 137 S.Ct. 1514, 1515 (2017).
`
`FACTUAL BACKGROUND
`
`24.
`
`CALQUENCE®, which contains acalabrutinib as its active ingredient, is a kinase
`
`inhibitor indicated for the treatment of adult patients with mantle cell lymphoma (“MCL”) who
`
`have received at least one prior therapy, and as a first-line treatment for chronic lymphocytic
`
`leukemia (“CLL”) or small lymphocytic lymphoma (“SLL”).
`
`25.
`
`On information and belief, Natco’s ANDA Product is a generic version of
`
`CALQUENCE®.
`
`26.
`
`By letter dated December 20, 2021 (“Natco’s Notice Letter”), Natco notified
`
`Plaintiffs that it had filed a Paragraph IV Certification with respect to the ’504 patent, the ’524
`
`patent, the ’721 patent, the ’291 patent, and the ’083 patent and was seeking approval from the
`
`ME1 39434122v.1
`
`6
`
`

`

`Case 1:22-cv-00155-UNA Document 1 Filed 02/02/22 Page 7 of 28 PageID #: 7
`
`FDA to engage in the commercial manufacture, use, offer for sale, sale, and/or importation of
`
`Natco’s ANDA Product prior to the expiration of those patents. On information and belief, Natco’s
`
`ANDA contains a Paragraph IV Certification asserting that the ’504 patent, the ’524 patent, the
`
`’721 patent, the ’291 patent, and the ’083 patent will not be infringed by the manufacture, use,
`
`offer for sale, sale, or importation of Natco’s ANDA Products, and/or that the Patents-in-Suit are
`
`invalid and/or unenforceable.
`
`27.
`
`The purpose of Natco’s submission of Natco’s ANDA was to obtain approval under
`
`the Federal Food, Drug and Cosmetic Act to engage in the commercial manufacture, use, offer for
`
`sale, sale, and/or importation of Natco’s ANDA Product prior to the expiration of the Patents-in-
`
`Suit.
`
`28.
`
`In Natco’s Notice Letter, Natco stated that the subject of Natco’s ANDA is for an
`
`acalabrutinib oral capsule, 100 mg.
`
`29.
`
`In an exchange of correspondence, counsel for Plaintiffs and counsel for Natco
`
`discussed the terms of Natco’s Offer of Confidential Access. The parties did not agree on terms
`
`under which Plaintiffs could review, among other things, Natco’s ANDA and the Drug Master File
`
`referred to therein, and Natco refused to produce samples of Natco’s ANDA Product and other
`
`internal documents and materials relevant to infringement.
`
`30.
`
`This action is being commenced before the expiration of forty-five days from the
`
`date of receipt of Natco’s Notice Letter.
`
`COUNT I – INFRINGEMENT OF THE ’504 PATENT
`UNDER 35 U.S.C. § 271(e)(2)
`
`31.
`
`Plaintiffs incorporate each of the preceding paragraphs 1–30 as if fully set forth
`
`herein.
`
`ME1 39434122v.1
`
`7
`
`

`

`Case 1:22-cv-00155-UNA Document 1 Filed 02/02/22 Page 8 of 28 PageID #: 8
`
`32.
`
`The
`
`’504 patent, entitled “4-Imidazopyridazin-1-yl-Benzamides and 4-
`
`Imidazotriazin-1-yl-Benzamides as BTK Inhibitors” (attached as Exhibit A), was duly and legally
`
`issued on March 22, 2016.
`
`33. Merck is the owner and assignee of the ’504 patent. AstraZeneca is exclusive
`
`licensee of the ’504 patent. Merck and AstraZeneca collectively possess all rights, title, and
`
`interest in the ’504 patent.
`
`34.
`
`The ’504 patent claims, inter alia, an isolated compound of the structure recited in
`
`claim 1, or a pharmaceutically acceptable salt thereof.
`
`35.
`
`The ’504 patent claims, inter alia, a compound which is (S)-4-(8-amino-3-(1-but-
`
`2-ynoylpyrrolidin-2-yl)imidazo[1,5-a]pyrazin-1-yl)-N-(pyridin-2-yl)benzamide,
`
`having
`
`the
`
`structure:
`
`as recited in claim 30 of the ’504 patent.
`
`36.
`
`CALQUENCE® is covered by one or more claims of the ’504 patent, including
`
`claims 1 and 30 of the ’504 patent, and the ’504 patent has been listed in connection with
`
`CALQUENCE® in the FDA’s publication Approved Drug Products with Therapeutic Equivalence
`
`Evaluations, also known as the “Orange Book.”
`8
`
`ME1 39434122v.1
`
`

`

`Case 1:22-cv-00155-UNA Document 1 Filed 02/02/22 Page 9 of 28 PageID #: 9
`
`37.
`
`Natco’s submission of Natco’s ANDA for the purpose of obtaining approval to
`
`engage in the commercial manufacture, use, offer for sale, sale, and/or importation of Natco’s
`
`ANDA Product prior to the expiration of the ’504 patent was an act of infringement of the ’504
`
`patent under 35 U.S.C. § 271(e)(2)(A).
`
`38.
`
`On information and belief, the manufacture, use, offer for sale, sale, marketing,
`
`distribution, and/or importation of Natco’s ANDA Product would infringe at least claims 1 and 30
`
`of the ’504 patent, recited above, either literally or under the doctrine of equivalents.
`
`39.
`
`In Natco’s Notice Letter, Natco did not contest the infringement of claims 1 and 30
`
`of the ’504 patent on any basis other than the alleged invalidity of those claims.
`
`40.
`
`On information and belief, Natco has not challenged U.S. Patent No. 7,459,554
`
`(“the ’554 patent”), which is listed in connection with CALQUENCE® in the FDA’s Orange Book
`
`and expires on November 24, 2026. On information and belief, following the expiration of the
`
`’554 patent, Natco will engage in the manufacture, use, offer for sale, sale, marketing, distribution,
`
`and/or importation of Natco’s ANDA Product immediately and imminently upon FDA approval
`
`of Natco’s ANDA.
`
`41.
`
`On information and belief, the use of Natco’s ANDA Product in accordance with
`
`and as directed by Natco’s proposed labeling for that product would infringe at least claims 1 and
`
`30 of the ’504 patent.
`
`42.
`
`On information and belief, Natco plans and intends to, and will, actively induce
`
`infringement of the ’504 patent when Natco’s ANDA is approved, and plans and intends to, and
`
`will, do so after approval.
`
`43.
`
`On information and belief, Natco knows that its ANDA Product and its proposed
`
`labeling are especially made or adapted for use in infringing the ’504 patent and that its ANDA
`
`ME1 39434122v.1
`
`9
`
`

`

`Case 1:22-cv-00155-UNA Document 1 Filed 02/02/22 Page 10 of 28 PageID #: 10
`
`Product and its proposed labeling is not suitable for substantial non-infringing use. On information
`
`and belief, Natco plans and intends to, and will, contribute to infringement of the ’504 patent after
`
`approval of Natco’s ANDA.
`
`44.
`
`The foregoing actions by Natco constitute and/or will constitute infringement of the
`
`’504 patent, active inducement of infringement of the ’504 patent, and contribution to the
`
`infringement by others of the ’504 patent.
`
`45.
`
`On information and belief, Natco has acted with full knowledge of the ’504 patent
`
`and without a reasonable basis for believing that it would not be liable for infringing the ’504
`
`patent, actively inducing infringement of the ’504 patent, and contributing to the infringement by
`
`others of the ’504 patent.
`
`46.
`
`Unless Natco is enjoined from infringing the ’504 patent, actively inducing
`
`infringement of the ’504 patent, and contributing to the infringement by others of the ’504 patent,
`
`Plaintiffs will suffer irreparable injury. Plaintiffs have no adequate remedy at law.
`
`COUNT II – DECLARATORY JUDGMENT OF INFRINGEMENT
`OF THE ’504 PATENT
`
`47.
`
`Plaintiffs incorporate each of the preceding paragraphs 1–46 as if fully set forth
`
`herein.
`
`48.
`
`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 or actual controversy between Plaintiffs on the
`
`one hand and Natco on the other regarding Natco’s infringement, active inducement of
`
`infringement, and contribution to the infringement by others of the ’504 patent.
`
`49.
`
`The Court should declare that the commercial manufacture, use, sale, offer for sale,
`
`or importation of Natco’s ANDA Product with its proposed labeling, or any other Natco drug
`
`product that is covered by or whose use is covered by the ’504 patent, will infringe, induce the
`10
`
`ME1 39434122v.1
`
`

`

`Case 1:22-cv-00155-UNA Document 1 Filed 02/02/22 Page 11 of 28 PageID #: 11
`
`infringement of, and contribute to the infringement by others of the ’504 patent, and that the claims
`
`of the ’504 patent are valid.
`
`COUNT III – INFRINGEMENT OF THE ’524 PATENT
`UNDER 35 U.S.C. § 271(e)(2)
`
`50.
`
`Plaintiffs incorporate each of the preceding paragraphs 1–49 as if fully set forth
`
`herein.
`
`51.
`
`The ’524 patent, entitled, “4-Imidazopyridazin-1-yl-Benzamides as BTK
`
`Inhibitors” (attached as Exhibit B), was duly and legally issued on September 12, 2017.
`
`52. Merck is the owner and assignee of the ’524 patent. AstraZeneca is exclusive
`
`licensee of the ’524 patent. Merck and AstraZeneca collectively possess all rights, title, and
`
`interest in the ’524 patent.
`
`53.
`
`The ’524 patent claims, inter alia, a method of treating Mantle Cell Lymphoma
`
`(“MCL”) in a human subject, the method comprising administering to the human subject a
`
`compound which is (S)-4-(8-amino-3-(1-but-2-ynoylpyrrolidin-2-yl)imidazo[1,5-a]pyrazin-1-yl)-
`
`N-(pyridin-2-yl)benzamide, having the structure:
`
`ME1 39434122v.1
`
`11
`
`

`

`Case 1:22-cv-00155-UNA Document 1 Filed 02/02/22 Page 12 of 28 PageID #: 12
`
`or a pharmaceutically acceptable salt thereof, in an amount effective to treat MCL in the human
`
`subject, as recited in claim 1 of the ’524 patent.
`
`54.
`
`CALQUENCE®, as well as methods of using CALQUENCE®, are covered by one
`
`or more claims of the ’524 patent, including claim 1 of the ’524 patent, and the ’524 patent has
`
`been listed in connection with CALQUENCE® in the FDA’s Orange Book.
`
`55.
`
`Natco’s submission of Natco’s ANDA for the purpose of obtaining approval to
`
`engage in the commercial manufacture, use, offer for sale, sale, and/or importation of Natco’s
`
`ANDA Product prior to the expiration of the ’524 patent was an act of infringement of the ’524
`
`patent under 35 U.S.C. § 271(e)(2)(A).
`
`56.
`
`On information and belief, the manufacture, use, offer for sale, sale, marketing,
`
`distribution, and/or importation of Natco’s ANDA Product would infringe at least claim 1 of the
`
`’524 patent, recited above, either literally or under the doctrine of equivalents.
`
`57.
`
`In Natco’s Notice Letter, Natco did not contest the infringement of claim 1 of the
`
`’524 patent on any basis other than the alleged invalidity of that claim.
`
`58.
`
`On information and belief, Natco has not challenged the ’554 patent, which is listed
`
`in connection with CALQUENCE® in the FDA’s Orange Book and expires on November 24,
`
`2026. On information and belief, following the expiration of the ’554 patent, Natco will engage
`
`in the manufacture, use, offer for sale, sale, marketing, distribution, and/or importation of Natco’s
`
`ANDA Product immediately and imminently upon FDA approval of Natco’s ANDA.
`
`59.
`
`On information and belief, the use of Natco’s ANDA Product in accordance with
`
`and as directed by Natco’s proposed labeling for that product would infringe at least claim 1 of the
`
`’524 patent.
`
`ME1 39434122v.1
`
`12
`
`

`

`Case 1:22-cv-00155-UNA Document 1 Filed 02/02/22 Page 13 of 28 PageID #: 13
`
`60.
`
`On information and belief, Natco plans and intends to, and will, actively induce
`
`infringement of the ’524 patent when Natco’s ANDA is approved, and plans and intends to, and
`
`will, do so after approval.
`
`61.
`
`On information and belief, Natco knows that its ANDA Product and its proposed
`
`labeling are especially made or adapted for use in infringing the ’524 patent and that its ANDA
`
`Product and its proposed labeling is not suitable for substantial non-infringing use. On information
`
`and belief, Natco plans and intends to, and will, contribute to infringement of the ’524 patent after
`
`approval of Natco’s ANDA.
`
`62.
`
`The foregoing actions by Natco constitute and/or will constitute infringement of the
`
`’524 patent, active inducement of infringement of the ’524 patent, and contribution to the
`
`infringement by others of the ’524 patent.
`
`63.
`
`On information and belief, Natco has acted with full knowledge of the ’524 patent
`
`and without a reasonable basis for believing that it would not be liable for infringing the ’524
`
`patent, actively inducing infringement of the ’524 patent, and contributing to the infringement by
`
`others of the ’524 patent.
`
`64.
`
`Unless Natco is enjoined from infringing the ’524 patent, actively inducing
`
`infringement of the ’524 patent, and contributing to the infringement by others of the ’524 patent,
`
`Plaintiffs will suffer irreparable injury. Plaintiffs have no adequate remedy at law.
`
`COUNT IV – DECLARATORY JUDGMENT OF INFRINGEMENT
`OF THE ’524 PATENT
`
`65.
`
`Plaintiffs incorporate each of the preceding paragraphs 1–64 as if fully set forth
`
`herein.
`
`66.
`
`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 or actual controversy between Plaintiffs on
`13
`
`ME1 39434122v.1
`
`

`

`Case 1:22-cv-00155-UNA Document 1 Filed 02/02/22 Page 14 of 28 PageID #: 14
`
`the one hand and Natco on the other regarding Natco’s infringement, active inducement of
`
`infringement, and contribution to the infringement by others of the ’524 patent.
`
`67.
`
`The Court should declare that the commercial manufacture, use, sale, offer for sale,
`
`or importation of Natco’s ANDA Product with its proposed labeling, or any other Natco drug
`
`product that is covered by or whose use is covered by the ’524 patent, will infringe, induce the
`
`infringement of, and contribute to the infringement by others of the ’524 patent, and that the claims
`
`of the ’524 patent are valid.
`
`COUNT V – INFRINGEMENT OF THE ’883 PATENT
`UNDER 35 U.S.C. § 271(e)(2)
`
`68.
`
`Plaintiffs incorporate each of the preceding paragraphs 1–67 as if fully set forth
`
`herein.
`
`69.
`
`The
`
`’883 patent, entitled “4-Imidazopyridazin-1-yl-Benzamides as BTK
`
`Inhibitors” (attached as Exhibit C), was duly and legally issued on March 26, 2019.
`
`70. Merck is the owner and assignee of the ’883 patent. AstraZeneca is exclusive
`
`licensee of the ’883 patent. Merck and AstraZeneca collectively possess all rights, title, and
`
`interest in the ’883 patent.
`
`71.
`
`The ’883 patent claims, inter alia, a method of treating chronic lymphocytic
`
`leukemia in a human subject, the method comprising administering to the human subject a
`
`compound which is (S)-4-(8-amino-3-(1-but-2-ynoylpyrrolidin-2-yl)imidazo[1,5-a]pyrazin-1-yl)-
`
`N-(pyridin-2-yl)benzamide, having the structure:
`
`ME1 39434122v.1
`
`14
`
`

`

`Case 1:22-cv-00155-UNA Document 1 Filed 02/02/22 Page 15 of 28 PageID #: 15
`
`or a pharmaceutically acceptable salt thereof, as recited in claim 1 of the ’883 patent.
`
`72.
`
`CALQUENCE®, as well as methods of using CALQUENCE®, are covered by one
`
`or more claims of the ’883 patent, including claim 1 of the ’883 patent, and the ’883 patent has
`
`been listed in connection with CALQUENCE® in the FDA’s Orange Book.
`
`73.
`
`Natco’s submission of Natco’s ANDA for the purpose of obtaining approval to
`
`engage in the commercial manufacture, use, offer for sale, sale, and/or importation of Natco’s
`
`ANDA Product prior to the expiration of the ’883 patent was an act of infringement of the ’883
`
`patent under 35 U.S.C. § 271(e)(2)(A).
`
`74.
`
`On information and belief, the manufacture, use, offer for sale, sale, marketing,
`
`distribution, and/or importation of Natco’s ANDA Product would infringe at least claim 1 of the
`
`’883 patent, recited above, either literally or under the doctrine of equivalents.
`
`75.
`
`On information and belief, Natco has not challenged the ’554 patent, which is listed
`
`in connection with CALQUENCE® in the FDA’s Orange Book and expires on November 24,
`
`2026. On information and belief, following the expiration of the ’554 patent, Natco will engage
`
`ME1 39434122v.1
`
`15
`
`

`

`Case 1:22-cv-00155-UNA Document 1 Filed 02/02/22 Page 16 of 28 PageID #: 16
`
`in the manufacture, use, offer for sale, sale, marketing, distribution, and/or importation of Natco’s
`
`ANDA Product immediately and imminently upon FDA approval of Natco’s ANDA.
`
`76.
`
`On information and belief, the use of Natco’s ANDA Product in accordance with
`
`and as directed by Natco’s proposed labeling for that product would infringe at least claim 1 of the
`
`’883 patent.
`
`77.
`
`On information and belief, Natco plans and intends to, and will, actively induce
`
`infringement of the ’883 patent when Natco’s ANDA is approved, and plans and intends to, and
`
`will, do so after approval.
`
`78.
`
`On information and belief, Natco knows that its ANDA Product and its proposed
`
`labeling are especially made or adapted for use in infringing the ’883 patent and that its ANDA
`
`Product and its proposed labeling is not suitable for substantial non-infringing use. On information
`
`and belief, Natco plans and intends to, and will, contribute to infringement of the ’883 patent after
`
`approval of Natco’s ANDA.
`
`79.
`
`The foregoing actions by Natco constitute and/or will constitute infringement of the
`
`’883 patent, active inducement of infringement of the ’883 patent, and contribution to the
`
`infringement by others of the ’883 patent.
`
`80.
`
`On information and belief, Natco has acted with full knowledge of the ’883 patent
`
`and without a reasonable basis for believing that it would not be liable for infringing the ’883
`
`patent, actively inducing infringement of the ’883 patent, and contributing to the infringement by
`
`others of the ’883 patent.
`
`81.
`
`Unless Natco is enjoined from infringing the ’883 patent, actively inducing
`
`infringement of the ’883 patent, and contributing to the infringement by others of the ’883 patent,
`
`Plaintiffs will suffer irreparable injury. Plaintiffs have no adequate remedy at law.
`
`ME1 39434122v.1
`
`16
`
`

`

`Case 1:22-cv-00155-UNA Document 1 Filed 02/02/22 Page 17 of 28 PageID #: 17
`
`COUNT VI – DECLARATORY JUDGMENT OF INFRINGEMENT
`OF THE ’883 PATENT
`
`82.
`
`Plaintiffs incorporate each of the preceding paragraphs 1–81 as if fully set forth
`
`herein.
`
`83.
`
`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 or actual controversy between Plaintiffs on
`
`the one hand and Natco on the other regarding Natco’s infringement, active inducement of
`
`infringement, and contribution to the infringement by others of the ’883 patent.
`
`84.
`
`The Court should declare that the commercial manufacture, use, sale, offer for sale,
`
`or importation of Natco’s ANDA Product with its proposed labeling, or any other Natco drug
`
`product that is covered by or whose use is covered by the ’883 patent, will infringe, induce the
`
`infringement of, and contribute to the infringement by others of the ’883 patent, and that the claims
`
`of the ’883 patent are valid.
`
`COUNT VII – INFRINGEMENT OF THE ’721 PATENT
`UNDER 35 U.S.C. § 271(e)(2)
`
`85.
`
`Plaintiffs incorporate each of the preceding paragraphs 1–84 as if fully set forth
`
`herein.
`
`86.
`
`The ’721 patent, entitled, “Crystal Forms of (S)-4-(8-amino-3-(1-but-2-
`
`ynoylpyrrolidin-2-yl)imidazo[1,5-a]pyrazin-1-yl)-N-(pyridin-2-yl)benzamide”
`
`(attached
`
`as
`
`Exhibit D), was duly and legally issued on October 24, 2017.
`
`87.
`
`Acerta Pharma B.V. is the owner and assignee of the ’721 patent. AstraZeneca has
`
`all rights, title, and interest in the ’721 patent.
`
`88.
`
`The ’721 patent claims, inter alia, a crystal form of (S)-4-(8-amino-3-(1-but-2-
`
`ynoylpyrrolidin-2-yl)imidazo[1,5-a]pyrazin-1-yl)-N-(pyridin-2-yl)benzamide characterized by an
`
`ME1 39434122v.1
`
`17
`
`

`

`Case 1:22-cv-00155-UNA Document 1 Filed 02/02/22 Page 18 of 28 PageID #: 18
`
`X-ray powder diffraction pattern comprising peaks at 6.4° ±0.2° 2θ, 8.6° ±0.2° 2θ, 10.5° ±0.2° 2θ,
`
`11.6° ±0.2° 2θ and 15.7° ±0.2° 2θ as recited in claim 1 of the ’721 patent.
`
`89.
`
`CALQUENCE®, as well as methods of using CALQUENCE®, are covered by one
`
`or more claims of the ’721 patent, including claim 1 of the ’721 patent, and the ’721 patent has
`
`been listed in connection with CALQUENCE ® in the FDA’s Orange Book.
`
`90.
`
`Natco’s submission of Natco’s ANDA for the purpose of obtaining approval to
`
`engage in the commercial manufacture, use, offer for sale, sale, and/or importation of Natco’s
`
`ANDA Product prior to the expiration of the ’721 patent was an act of infringement of the ’721
`
`patent under 35 U.S.C. § 271(e)(2)(A).
`
`91.
`
`On information and belief, the manufacture, use, offer for sale, sale, marketing,
`
`distribution, and/or importation of Natco’s ANDA Product would infringe at least claim 1 of the
`
`’721 patent, recited above, either literally or under the doctrine of equivalents.
`
`92.
`
`On information and belief, Natco has not challenged the ’554 patent, which is listed
`
`in connection with CALQUENCE® in the FDA’s Orange Book and expires on November 24,
`
`2026. On information and belief, following the expiration of the ’554 patent, Natco will engage
`
`in the manufacture, use, offer for sale, sale, marketing, distribution, and/or importation of Natco’s
`
`ANDA Product immediately and imminently upon FDA approval of Natco’s ANDA.
`
`93.
`
`On information and belief, the use of Natco’s ANDA Product in accordance with
`
`and as directed by Natco’s proposed labeling for that product would infringe at least claim 1 of the
`
`’721 patent.
`
`94.
`
`On information and belief, Natco plans and intends to, and will, actively induce
`
`infringement of the ’721 patent when Natco’s ANDA is approved, and plans and intends to, and
`
`will, do so after approval.
`
`ME1 39434122v.1
`
`18
`
`

`

`Case 1:22-cv-00155-UNA Document 1 Filed 02/02/22 Page 19 of 28 PageID #: 19
`
`95.
`
`On information and belief, Natco knows that its ANDA Product and its proposed
`
`labeling are especially made or adapted for use in infringing the ’721 patent and that its ANDA
`
`Product and its proposed labeling is not suitable for substantial non-infringing use. On information
`
`and belief, Natco plans and intends to, and will, contribute to infringement of the ’721 patent after
`
`approval of Natco’s ANDA.
`
`96.
`
`The foregoing actions by Natco constitute and/or will constitute infringement of the
`
`’721 patent, active inducement of infringement of the ’721 patent, and contribution to the
`
`infringement by others of the ’721 patent.
`
`97.
`
`On information and belief, Natco has acted with full knowledge of the ’721 patent
`
`and witho