`
`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.,
`
`SANDOZ INC.,
`
`Plaintiffs,
`
`v.
`
`Defendant.
`
`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 Sandoz Inc.
`
`(“Sandoz”), 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 Sandoz of Abbreviated New Drug
`
`New Drug Application (“ANDA”) No. 216405 (“Sandoz’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
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`SANDOZ INC.
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`IPR2023-00478
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`Ex. 1046, p. 1 of 27
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`
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`Case 1:22-cv-00164-UNA Document 1 Filed 02/04/22 Page 2 of 27 PageID #: 2
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`’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 Sandoz is a corporation organized and
`
`existing under the laws of the State of Delaware with a principal place of business at 100 College
`
`Road West, Princeton, NJ 08540. On information and belief, Sandoz is in the business of, among
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`SANDOZ INC.
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`IPR2023-00478
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`Ex. 1046, p. 2 of 27
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`Case 1:22-cv-00164-UNA Document 1 Filed 02/04/22 Page 3 of 27 PageID #: 3
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`other things, manufacturing and selling generic versions of branded pharmaceutical products for
`
`the U.S. market.
`
`8.
`
`On information and belief, Sandoz knows and intends that upon approval of
`
`Sandoz’s ANDA, Sandoz will manufacture Sandoz’s ANDA Products and directly or indirectly
`
`market, sell, and distribute them throughout the United States, including in Delaware.
`
`JURISDICTION
`
`9.
`
`Plaintiffs incorporate each of the preceding paragraphs 1–8 as if fully set forth
`
`herein.
`
`10.
`
`This Court has subject matter jurisdiction over this action pursuant to 28 U.S.C. §§
`
`1331, 1338(a), 2201, and 2202.
`
`11.
`
`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 Sandoz.
`
`12.
`
`Sandoz 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. Sandoz 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, Sandoz 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.
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`SANDOZ INC.
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`IPR2023-00478
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`Ex. 1046, p. 3 of 27
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`
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`Case 1:22-cv-00164-UNA Document 1 Filed 02/04/22 Page 4 of 27 PageID #: 4
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`13.
`
`In addition, this Court has personal jurisdiction over Sandoz because, among other
`
`things, on information and belief: (1) Sandoz filed Sandoz’s ANDA for the purpose of seeking
`
`approval to engage in the commercial manufacture, use, offer for sale, sale, and/or importation of
`
`Sandoz’s ANDA Product in the United States, including in Delaware; and (2) upon approval of
`
`Sandoz’s ANDA, Sandoz will market, distribute, offer for sale, sell, and/or import Sandoz’s
`
`ANDA Product in the United States, including in Delaware, and will derive substantial revenue
`
`from the use or consumption of Sandoz’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 Sandoz’s ANDA, Sandoz’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.
`
`14.
`
`In addition, this Court has personal jurisdiction over Sandoz because Sandoz
`
`regularly (1) engages in patent litigation concerning Sandoz’s ANDA products in this District, (2)
`
`does not contest personal jurisdiction in this District, and (3) purposefully avails itself of the rights
`
`and benefits of this Court by asserting claims and/or counterclaims in this District. See, e.g., In
`
`re: Copaxone 775 Patent Litig., C.A. No. 16-1267-GMS (D. Del. Sept. 27, 2018); Bristol-Myers
`
`Squibb Company et al. v. Sandoz Inc., No. 1:17-cv-00407-LPS (D. Del. June 12, 2017); Forest
`
`Laboratories, LLC et al. v. Apotex Corp. et al., C.A. No. 1:15-cv-18-GMS (D. Del. Feb. 22, 2016).
`
`15.
`
`For the above reasons, it would not be unfair or unreasonable for Sandoz to litigate
`
`this action in this District, and the Court has personal jurisdiction over it here.
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`SANDOZ INC.
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`IPR2023-00478
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`Ex. 1046, p. 4 of 27
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`Case 1:22-cv-00164-UNA Document 1 Filed 02/04/22 Page 5 of 27 PageID #: 5
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`16.
`
`Plaintiffs incorporate each of the preceding paragraphs 1–15 as if fully set forth
`
`VENUE
`
`herein.
`
`17.
`
`Venue is proper in this district as to Sandoz pursuant to 28 U.S.C. § 1400(b)
`
`because, inter alia, Sandoz 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
`
`18.
`
`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”).
`
`19.
`
`On information and belief, Sandoz’s ANDA Product is a generic version of
`
`CALQUENCE®.
`
`20.
`
`By letter dated December 28, 2021 (“Sandoz’s Notice Letter”), Sandoz 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
`
`FDA to engage in the commercial manufacture, use, offer for sale, sale, and/or importation of
`
`Sandoz’s ANDA Product prior to the expiration of those patents. On information and belief,
`
`Sandoz’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 Sandoz’s ANDA Products, and/or that the
`
`Patents-in-Suit are invalid and/or unenforceable.
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`5
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`Ex. 1046, p. 5 of 27
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`Case 1:22-cv-00164-UNA Document 1 Filed 02/04/22 Page 6 of 27 PageID #: 6
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`21.
`
`The purpose of Sandoz’s submission of Sandoz’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 Sandoz’s ANDA Product prior to the expiration of the
`
`Patents-in-Suit.
`
`22.
`
`In Sandoz’s Notice Letter, Sandoz stated that the subject of Sandoz’s ANDA is for
`
`an acalabrutinib oral capsule, 100 mg.
`
`23.
`
`In an exchange of correspondence, counsel for Plaintiffs and counsel for Sandoz
`
`discussed the terms of Sandoz’s Offer of Confidential Access. The parties did not agree on terms
`
`under which Plaintiffs could review, among other things, Sandoz’s ANDA or the Drug Master File
`
`referred to in Sandoz’s ANDA, and Sandoz did not provide all information that Plaintiffs
`
`requested.
`
`24.
`
`This action is being commenced before the expiration of forty-five days from the
`
`date of receipt of Sandoz’s Notice Letter.
`
`COUNT I – INFRINGEMENT OF THE ’504 PATENT
`UNDER 35 U.S.C. § 271(e)(2)
`
`25.
`
`Plaintiffs incorporate each of the preceding paragraphs 1–24 as if fully set forth
`
`herein.
`
`26.
`
`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.
`
`27. 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.
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`SANDOZ INC.
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`IPR2023-00478
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`Ex. 1046, p. 6 of 27
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`Case 1:22-cv-00164-UNA Document 1 Filed 02/04/22 Page 7 of 27 PageID #: 7
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`28.
`
`The ’504 patent claims, inter alia, an isolated compound of the structure recited in
`
`claim 1, or a pharmaceutically acceptable salt thereof.
`
`29.
`
`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.
`
`30.
`
`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.”
`
`31.
`
`Sandoz’s submission of Sandoz’s ANDA for the purpose of obtaining approval to
`
`engage in the commercial manufacture, use, offer for sale, sale, and/or importation of Sandoz’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).
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`SANDOZ INC.
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`IPR2023-00478
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`Ex. 1046, p. 7 of 27
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`Case 1:22-cv-00164-UNA Document 1 Filed 02/04/22 Page 8 of 27 PageID #: 8
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`32.
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`On information and belief, the manufacture, use, offer for sale, sale, marketing,
`
`distribution, and/or importation of Sandoz’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.
`
`33.
`
`In Sandoz’s Notice Letter, Sandoz 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.
`
`34.
`
`On information and belief, Sandoz 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, Sandoz will engage in the manufacture, use, offer for sale, sale, marketing,
`
`distribution, and/or importation of Sandoz’s ANDA Product immediately and imminently upon
`
`FDA approval of Sandoz’s ANDA.
`
`35.
`
`On information and belief, the use of Sandoz’s ANDA Product in accordance with
`
`and as directed by Sandoz’s proposed labeling for that product would infringe at least claims 1 and
`
`30 of the ’504 patent.
`
`36.
`
`On information and belief, Sandoz plans and intends to, and will, actively induce
`
`infringement of the ’504 patent when Sandoz’s ANDA is approved, and plans and intends to, and
`
`will, do so after approval.
`
`37.
`
`On information and belief, Sandoz 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
`
`Product and its proposed labeling is not suitable for substantial non-infringing use. On information
`
`and belief, Sandoz plans and intends to, and will, contribute to infringement of the ’504 patent
`
`after approval of Sandoz’s ANDA.
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`SANDOZ INC.
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`IPR2023-00478
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`Ex. 1046, p. 8 of 27
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`Case 1:22-cv-00164-UNA Document 1 Filed 02/04/22 Page 9 of 27 PageID #: 9
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`38.
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`The foregoing actions by Sandoz 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.
`
`39.
`
`On information and belief, Sandoz 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.
`
`40.
`
`Unless Sandoz 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
`
`41.
`
`Plaintiffs incorporate each of the preceding paragraphs 1–40 as if fully set forth
`
`herein.
`
`42.
`
`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 Sandoz on the other regarding Sandoz’s infringement, active inducement of
`
`infringement, and contribution to the infringement by others of the ’504 patent.
`
`43.
`
`The Court should declare that the commercial manufacture, use, sale, offer for sale,
`
`or importation of Sandoz’s ANDA Product with its proposed labeling, or any other Sandoz drug
`
`product that is covered by or whose use is covered by the ’504 patent, will infringe, induce the
`
`infringement of, and contribute to the infringement by others of the ’504 patent, and that the claims
`
`of the ’504 patent are valid.
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`SANDOZ INC.
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`IPR2023-00478
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`Ex. 1046, p. 9 of 27
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`Case 1:22-cv-00164-UNA Document 1 Filed 02/04/22 Page 10 of 27 PageID #: 10
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`COUNT III – INFRINGEMENT OF THE ’524 PATENT
`UNDER 35 U.S.C. § 271(e)(2)
`
`44.
`
`Plaintiffs incorporate each of the preceding paragraphs 1–43 as if fully set forth
`
`herein.
`
`45.
`
`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.
`
`46. 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.
`
`47.
`
`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:
`
`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.
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`IPR2023-00478
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`Ex. 1046, p. 10 of 27
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`Case 1:22-cv-00164-UNA Document 1 Filed 02/04/22 Page 11 of 27 PageID #: 11
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`48.
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`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.
`
`49.
`
`Sandoz’s submission of Sandoz’s ANDA for the purpose of obtaining approval to
`
`engage in the commercial manufacture, use, offer for sale, sale, and/or importation of Sandoz’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).
`
`50.
`
`On information and belief, the manufacture, use, offer for sale, sale, marketing,
`
`distribution, and/or importation of Sandoz’s ANDA Product would infringe at least claim 1 of the
`
`’524 patent, recited above, either literally or under the doctrine of equivalents.
`
`51.
`
`In Sandoz’s Notice Letter, Sandoz did not contest the infringement of claim 1 of
`
`the ’524 patent on any basis other than the alleged invalidity of that claim.
`
`52.
`
`On information and belief, Sandoz 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, Sandoz will
`
`engage in the manufacture, use, offer for sale, sale, marketing, distribution, and/or importation of
`
`Sandoz’s ANDA Product immediately and imminently upon FDA approval of Sandoz’s ANDA.
`
`53.
`
`On information and belief, the use of Sandoz’s ANDA Product in accordance with
`
`and as directed by Sandoz’s proposed labeling for that product would infringe at least claim 1 of
`
`the ’524 patent.
`
`54.
`
`On information and belief, Sandoz plans and intends to, and will, actively induce
`
`infringement of the ’524 patent when Sandoz’s ANDA is approved, and plans and intends to, and
`
`will, do so after approval.
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`SANDOZ INC.
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`IPR2023-00478
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`Ex. 1046, p. 11 of 27
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`Case 1:22-cv-00164-UNA Document 1 Filed 02/04/22 Page 12 of 27 PageID #: 12
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`55.
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`On information and belief, Sandoz 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, Sandoz plans and intends to, and will, contribute to infringement of the ’524 patent
`
`after approval of Sandoz’s ANDA.
`
`56.
`
`The foregoing actions by Sandoz 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.
`
`57.
`
`On information and belief, Sandoz 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.
`
`58.
`
`Unless Sandoz 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
`
`59.
`
`Plaintiffs incorporate each of the preceding paragraphs 1–58 as if fully set forth
`
`herein.
`
`60.
`
`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 Sandoz on the other regarding Sandoz’s infringement, active inducement of
`
`infringement, and contribution to the infringement by others of the ’524 patent.
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`SANDOZ INC.
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`IPR2023-00478
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`Ex. 1046, p. 12 of 27
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`Case 1:22-cv-00164-UNA Document 1 Filed 02/04/22 Page 13 of 27 PageID #: 13
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`61.
`
`The Court should declare that the commercial manufacture, use, sale, offer for sale,
`
`or importation of Sandoz’s ANDA Product with its proposed labeling, or any other Sandoz 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)
`
`62.
`
`Plaintiffs incorporate each of the preceding paragraphs 1–61 as if fully set forth
`
`herein.
`
`63.
`
`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.
`
`64. 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.
`
`65.
`
`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:
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`ME1 39469358v.1
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`13
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`SANDOZ INC.
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`IPR2023-00478
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`Ex. 1046, p. 13 of 27
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`
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`Case 1:22-cv-00164-UNA Document 1 Filed 02/04/22 Page 14 of 27 PageID #: 14
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`or a pharmaceutically acceptable salt thereof, as recited in claim 1 of the ’883 patent.
`
`66.
`
`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.
`
`67.
`
`Sandoz’s submission of Sandoz’s ANDA for the purpose of obtaining approval to
`
`engage in the commercial manufacture, use, offer for sale, sale, and/or importation of Sandoz’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).
`
`68.
`
`On information and belief, the manufacture, use, offer for sale, sale, marketing,
`
`distribution, and/or importation of Sandoz’s ANDA Product would infringe at least claim 1 of the
`
`’883 patent, recited above, either literally or under the doctrine of equivalents.
`
`69.
`
`On information and belief, Sandoz 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, Sandoz will
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`Ex. 1046, p. 14 of 27
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`Case 1:22-cv-00164-UNA Document 1 Filed 02/04/22 Page 15 of 27 PageID #: 15
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`engage in the manufacture, use, offer for sale, sale, marketing, distribution, and/or importation of
`
`Sandoz’s ANDA Product immediately and imminently upon FDA approval of Sandoz’s ANDA.
`
`70.
`
`On information and belief, the use of Sandoz’s ANDA Product in accordance with
`
`and as directed by Sandoz’s proposed labeling for that product would infringe at least claim 1 of
`
`the ’883 patent.
`
`71.
`
`On information and belief, Sandoz plans and intends to, and will, actively induce
`
`infringement of the ’883 patent when Sandoz’s ANDA is approved, and plans and intends to, and
`
`will, do so after approval.
`
`72.
`
`On information and belief, Sandoz 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, Sandoz plans and intends to, and will, contribute to infringement of the ’883 patent
`
`after approval of Sandoz’s ANDA.
`
`73.
`
`The foregoing actions by Sandoz 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.
`
`74.
`
`On information and belief, Sandoz 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.
`
`75.
`
`Unless Sandoz 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.
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`SANDOZ INC.
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`IPR2023-00478
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`Ex. 1046, p. 15 of 27
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`Case 1:22-cv-00164-UNA Document 1 Filed 02/04/22 Page 16 of 27 PageID #: 16
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`COUNT VI – DECLARATORY JUDGMENT OF INFRINGEMENT
`OF THE ’883 PATENT
`
`76.
`
`Plaintiffs incorporate each of the preceding paragraphs 1–75 as if fully set forth
`
`herein.
`
`77.
`
`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 Sandoz on the other regarding Sandoz’s infringement, active inducement of
`
`infringement, and contribution to the infringement by others of the ’883 patent.
`
`78.
`
`The Court should declare that the commercial manufacture, use, sale, offer for sale,
`
`or importation of Sandoz’s ANDA Product with its proposed labeling, or any other Sandoz 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)
`
`79.
`
`Plaintiffs incorporate each of the preceding paragraphs 1–78 as if fully set forth
`
`herein.
`
`80.
`
`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.
`
`81.
`
`Acerta Pharma B.V. is the owner and assignee of the ’721 patent. AstraZeneca has
`
`all rights, title, and interest in the ’721 patent.
`
`82.
`
`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
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`IPR2023-00478
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`Ex. 1046, p. 16 of 27
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`
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`Case 1:22-cv-00164-UNA Document 1 Filed 02/04/22 Page 17 of 27 PageID #: 17
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`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.
`
`83.
`
`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.
`
`84.
`
`Sandoz’s submission of Sandoz’s ANDA for the purpose of obtaining approval to
`
`engage in the commercial manufacture, use, offer for sale, sale, and/or importation of Sandoz’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).
`
`85.
`
`On information and belief, the manufacture, use, offer for sale, sale, marketing,
`
`distribution, and/or importation of Sandoz’s ANDA Product would infringe at least claim 1 of the
`
`’721 patent, recited above, either literally or under the doctrine of equivalents.
`
`86.
`
`On information and belief, Sandoz 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, Sandoz will
`
`engage in the manufacture, use, offer for sale, sale, marketing, distribution, and/or importation of
`
`Sandoz’s ANDA Product immediately and imminently upon FDA approval of Sandoz’s ANDA.
`
`87.
`
`On information and belief, the use of Sandoz’s ANDA Product in accordance with
`
`and as directed by Sandoz’s proposed labeling for that product would infringe at least claim 1 of
`
`the ’721 patent.
`
`88.
`
`On information and belief, Sandoz plans and intends to, and will, actively induce
`
`infringement of the ’721 patent when Sandoz’s ANDA is approved, and plans and intends to, and
`
`will, do so after approval.
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`SANDOZ INC.
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`IPR2023-00478
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`Ex. 1046, p. 17 of 27
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`
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`Case 1:22-cv-00164-UNA Document 1 Filed 02/04/22 Page 18 of 27 PageID #: 18
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`89.
`
`On information and belief, Sandoz 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, Sandoz plans and intends to, and will, contribute to infringement of the ’721 patent
`
`after approval of Sandoz’s ANDA.
`
`90.
`
`The foregoing actions by Sandoz 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.
`
`91.
`
`On information and belief, Sandoz has acted with full knowledge of the ’721 patent
`
`and without a reasonable basis for believing that it would not be liable for infringing the ’721
`
`patent, actively inducing infringement of the ’721 patent, and contributing to the infringement by
`
`others of the ’721 patent.
`
`92.
`
`Unless Sandoz is enjoined from infringing the ’721 patent, actively inducing
`
`infringement of the ’721 patent, and contributing to the infringement by others of the ’721 patent,
`
`Plaintiffs will suffer irreparable injury. Plaintiffs have no adequate remedy at law.
`
`COUNT VIII – DECLARATORY JUDGMENT OF INFRINGEMENT
`OF THE ’721 PATENT
`
`93.
`
`Plaintiffs incorporate each of the preceding paragraphs 1–92 as if fully set forth
`
`herein.
`
`94.
`
`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 Sandoz on the other regarding Sandoz’s infringement, active inducement of
`
`infringement, and contribution to the infringement by others of the ’721 patent.
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`SANDOZ INC.
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`IPR2023-00478
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`Ex. 1046, p. 18 of 27
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`
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`Case 1:22-cv-00164-UNA Document 1 Filed 02/04/22 Page 19 of 27 PageID #: 19
`
`95.
`
`The Court should declare that the commercial manufacture, use, sale, offer for sale,
`
`or importation of Sandoz’s ANDA Product with its proposed labeling, or any other Sandoz drug
`
`product that is covered by or whose use is covered by the ’721 patent, will infringe, induce the
`
`infringement of, and contribute to the infringement by others of the ’721 patent, and that the claims
`
`of the ’721 patent are valid.
`
`COUNT IX – INFRINGEMENT OF THE ’291 PATENT
`UNDER 35 U.S.C. § 271(e)(2)
`
`96.
`
`Plaintiffs incorporate each of the preceding paragraphs 1–95 as if fully set forth
`
`herein.
`
`97.
`
`The ’291 patent, entitled, “Pharmaceutical Compositions Comprising a Crystal
`
`Form of (S)-4-(8-amino-3-(1-but-2-ynoylpyrrolidin-2-