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Case 1:22-cv-01099-UNA Document 1 Filed 08/22/22 Page 1 of 25 PageID #: 1
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`
`C.A. No. ____________
`
`))))))))))))))
`
`ZS PHARMA, INC. and
`ASTRAZENECA PHARMACEUTICALS
`LP,
`
`Plaintiffs,
`
`v.
`
`ASCENT PHARMACEUTICALS INC.
`AND HETERO DRUGS LTD.,
`
`Defendants.
`
`COMPLAINT FOR PATENT INFRINGEMENT
`
`Plaintiffs ZS Pharma, Inc. and AstraZeneca Pharmaceuticals LP, collectively,
`
`“AstraZeneca” or “Plaintiffs”, bring this action for patent infringement against Ascent
`
`Pharmaceuticals Inc. (“Ascent”) and Hetero Drugs Ltd. (“Hetero”), collectively, “Defendants”.
`
`NATURE OF THE ACTION
`
`This is a civil action for patent infringement arising under the patent laws of the
`
`United States, 35 U.S.C. § 1, et seq., and in particular under 35 U.S.C. § 271. This action relates
`
`to Abbreviated New Drug Application (“ANDA”) No. 217578, filed by and for the benefit of
`
`Defendants with the United States Food and Drug Administration (“FDA”). Through ANDA No.
`
`217578, Defendants seek approval to market generic versions of LOKELMA® (sodium zirconium
`
`cyclosilicate) for oral suspension 5 g per packet and 10 g per packet (the “Proposed ANDA
`
`Product”), prior to the expiration of U.S. Patent Nos. 8,802,152 (“the ’152 Patent”), 8,808,750
`
`(“the ’750 Patent”), 8,877,255 (“the ’255 Patent”), 9,592,253 (“the ’253 Patent”), 9,844,567 (“the
`
`’567 Patent”), 9,861,658 (“the ’658 Patent”), 9,913,860 (“the ’860 Patent”), 10,300,087 (“the ’087
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`Patent”), 10,335,432 (“the ’432 Patent”), 10,398,730 (“the ’730 Patent”), 10,413,569 (“the ’569
`
`Patent”), and 10,695,365 (“the ’365 Patent”) (collectively, “the Patents-in-Suit”).
`
`THE PARTIES
`
`Plaintiff ZS Pharma, Inc. is a corporation organized and existing under the laws of
`
`Delaware, having a principal place of business in Wilmington, Delaware.
`
`Plaintiff AstraZeneca Pharmaceuticals LP is a limited partnership organized and
`
`existing under the laws of Delaware, having a principal place of business in Wilmington,
`
`Delaware.
`
`On information and belief, Defendant Ascent is a corporation organized and
`
`existing under the laws of the State of New York, having a principal place of business at 400 South
`
`Technology Drive, Central Islip, New York.
`
`On information and belief, Defendant Hetero is a corporation organized and
`
`existing under the laws of the Republic of India, having a principal place of business at 7-2-A2,
`
`Hetero Corporate Industrial Estates, Sanath Nagar, Hyderabad – 500 018, Telangana, India.
`
`On information and belief, Defendants collaborate with respect to the development,
`
`regulatory approval, marketing, sale, and/or distribution of pharmaceutical products. On further
`
`information and belief, Defendants are agents of each other and/or operate in concert as integrated
`
`parts of the same business group.
`
`On information and belief, Defendants acted in concert to develop the Proposed
`
`ANDA Product that is the subject of ANDA No. 217578 and to seek regulatory approval from the
`
`FDA to market and sell the Proposed ANDA Product throughout the United States, including
`
`within this District.
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`Defendants’ ANDA No. 217578 seeks approval to commercially manufacture, use,
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`offer for sale, sell, and/or import a generic version of AstraZeneca’s LOKELMA® (sodium
`
`zirconium cyclosilicate) for oral suspension 5 g per packet and 10 g per packet prior to the
`
`expiration of the Patents-in-Suit.
`
`On information and belief, Defendants’ ANDA No. 217578 references a Drug
`
`Master File for sodium zirconium cyclosilicate held by Hetero Drugs Ltd.
`
`On information and belief, Defendants intend to act collaboratively to obtain
`
`approval for Defendants’ ANDA No. 217578, and, in the event the FDA approves that ANDA, to
`
`commercially manufacture, use, offer for sale, sell, and/or import the Proposed ANDA Product.
`
`JURISDICTION AND VENUE
`
`This is an action for patent infringement under the patent laws of the United States,
`
`Title 35, United States Code, arising out of the submission of Defendants’ ANDA No. 217578 to
`
`the FDA.
`
`This Court has subject matter jurisdiction over this action pursuant to 28 U.S.C.
`
`§§ 1331 and 1338(a), and 35 U.S.C. § 1 et seq.
`
`This Court has personal jurisdiction over Defendants because, inter alia, they have
`
`maintained continuous and systematic contacts with this District and availed themselves of the
`
`privilege of doing business in this District. On information and belief, Defendants: (1) acted in
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`concert to file ANDA No. 217578 seeking approval to commercially manufacture, use, offer for
`
`sale, sell, and/or import the Proposed ANDA Product in the United States, including in this
`
`District; (2) regularly and continuously transacted business within this District, including by
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`selling pharmaceutical products in this District either on their own or through their affiliates; and
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`(3) derived substantial revenue from the sale of those products in this District. Alternatively, this
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`Court has personal jurisdiction over Hetero pursuant to Federal Rule of Civil Procedure 4(k)(2).
`
`On information and belief, if ANDA No. 217578 is approved, the Proposed ANDA
`
`Product accused of infringing the Patents-in-Suit will be marketed, distributed, offered for sale,
`
`and/or sold in this District, prescribed by physicians practicing in this District, dispensed by
`
`pharmacies located within this District, and/or used by patients in this District, all of which would
`
`have a substantial effect on this District.
`
`This Court also has personal jurisdiction over Defendants because they have
`
`affirmatively availed themselves of the jurisdiction of this Court through the assertion of
`
`counterclaims in suits brought in this District and/or by being sued in this District without
`
`challenging personal jurisdiction. See, e.g., Vifor Pharma, Inc. et al. v. Alkem Laboratories Ltd.
`
`et al., 20-106 (D. Del.); Anacor Pharmaceuticals, Inc. v. Ascent Pharmaceuticals, Inc., et al., 18-
`
`1673 (D. Del.); Duchesnay Inc. et al. v. Hetero Labs Limited, 21-1130 (D. Del.); Otsuka
`
`Pharmaceutical Co., Ltd. et al. v. Hetero Labs, Ltd., 20-cv-1531 (D. Del.).
`
`This Court also has personal jurisdiction over Ascent at least because Ascent has
`
`confirmed that it will not contest personal jurisdiction in this District for purposes of litigation
`
`involving ANDA No. 217578.
`
`For the reasons set forth above, and for additional reasons which will be supplied
`
`if Defendants challenge personal jurisdiction in this action, Defendants are subject to personal
`
`jurisdiction in this District.
`
`Venue is proper in this District for Ascent at least because Ascent has confirmed
`
`that it will not contest venue in this District for purposes of litigation involving ANDA No. 217578.
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`Venue is proper in this District for Hetero pursuant to 28 U.S.C. § 1391(c) because,
`
`inter alia, Hetero is a corporation organized and existing under the laws of the Republic of India
`
`and is subject to personal jurisdiction in this District.
`
`THE PATENTS-IN-SUIT
`
`The Patents-in-Suit are assigned to ZS Pharma, Inc.
`
`The ’152 Patent, entitled “Microporous Zirconium Silicate for the Treatment of
`
`Hyperkalemia,” was duly and legally issued on August 12, 2014. A copy of the ’152 Patent is
`
`attached as Exhibit A.
`
`The ’750 Patent, entitled “Microporous Zirconium Silicate for the Treatment of
`
`Hyperkalemia,” was duly and legally issued on August 19, 2014. A copy of the ’750 Patent is
`
`attached as Exhibit B.
`
`The ’255 Patent, entitled “Microporous Zirconium Silicate for the Treatment of
`
`Hyperkalemia,” was duly and legally issued on November 4, 2014. A copy of the ’255 Patent is
`
`attached as Exhibit C.
`
`The ’253 Patent, entitled “Extended Use Zirconium Silicate Compositions and
`
`Methods of Use Thereof,” was duly and legally issued on March 14, 2017. A copy of the ’253
`
`Patent is attached as Exhibit D.
`
`The ’567 Patent, entitled “Microporous Zirconium Silicate for the Treatment of
`
`Hyperkalemia,” was duly and legally issued on December 19, 2017. A copy of the ’567 Patent is
`
`attached as Exhibit E.
`
`The ’658 Patent, entitled “Microporous Zirconium Silicate for the Treatment of
`
`Hyperkalemia,” was duly and legally issued on January 9, 2018. A copy of the ’658 Patent is
`
`attached as Exhibit F.
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`The ’860 Patent, entitled “Microporous Zirconium Silicate for the Treatment of
`
`Hyperkalemia,” was duly and legally issued on March 13, 2018. A copy of the ’860 Patent is
`
`attached as Exhibit G.
`
`The ’087 Patent, entitled “Extended Use Zirconium Silicate Compositions and
`
`Methods of Use Thereof,” was duly and legally issued on May 28, 2019. A copy of the ’087 Patent
`
`is attached as Exhibit H.
`
`The ’432 Patent, entitled “Microporous Zirconium Silicate for the Treatment of
`
`Hyperkalemia,” was duly and legally issued on July 2, 2019. A copy of the ’432 Patent is attached
`
`as Exhibit I.
`
`The ’730 Patent, entitled “Microporous Zirconium Silicate for the Treatment of
`
`Hyperkalemia,” was duly and legally issued on September 3, 2019. A copy of the ’730 Patent is
`
`attached as Exhibit J.
`
`The ’569 Patent, entitled “Microporous Zirconium Silicate for the Treatment of
`
`Hyperkalemia,” was duly and legally issued on September 17, 2019. A copy of the ’569 Patent is
`
`attached as Exhibit K.
`
`The ’365 Patent, entitled “Microporous Zirconium Silicate for the Treatment of
`
`Hyperkalemia,” was duly and legally issued on June 30, 2020. A copy of the ’365 Patent is
`
`attached as Exhibit L.
`
`FACTUAL BACKGROUND
`
`LOKELMA® (sodium zirconium cyclosilicate)
`
`LOKELMA® (sodium zirconium cyclosilicate) is a drug used to treat hyperkalemia.
`
`Marked elevations in serum potassium can cause fatal heart arrhythmias and abnormalities in
`
`conduction (progression of electrical impulses through the heart) and muscle weakness and
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`paralysis. LOKELMA® (sodium zirconium cyclosilicate) is a non-absorbed zirconium silicate that
`
`preferentially captures potassium in exchange for hydrogen and sodium, thereby lowering serum
`
`potassium levels.
`
`AstraZeneca is the holder of approved New Drug Application (“NDA”) No. 207078
`
`for LOKELMA® (sodium zirconium cyclosilicate) for oral suspension 5 g per packet and 10 g per
`
`packet. Pursuant to NDA No. 207078, AstraZeneca markets and distributes LOKELMA® (sodium
`
`zirconium cyclosilicate) for oral suspension 5 g per packet and 10 g per packet in the United States.
`
`LOKELMA® (sodium zirconium cyclosilicate) for oral suspension 5 g per packet
`
`and 10 g per packet, the active pharmaceutical ingredient sodium zirconium cyclosilicate, the
`
`method of manufacture, and/or their use are covered by one or more claims of the Patents-in-Suit.
`
`The Patents-in-Suit have been listed for NDA No. 207078 in the FDA publication Approved Drug
`
`Products with Therapeutic Equivalence Evaluations, which is also known as the “Orange Book.”
`
`Defendants’ ANDA No. 217578
`
`In a letter dated July 18, 2022 (the “Notice Letter”), Defendants stated that they had
`
`submitted ANDA No. 217578 to the FDA seeking approval to commercially manufacture, use,
`
`offer for sale, sell, and/or import the Proposed ANDA Product prior to the expiration of the Patents-
`
`in-Suit. The Notice Letter further stated that ANDA No. 217578 contained a certification pursuant
`
`to 21 U.S.C. § 355(j)(2)(A)(vii)(IV) (a “Paragraph IV Certification”) that the Patents-in-Suit are
`
`invalid, unenforceable, and/or will not be infringed by the commercial manufacture, use, offer for
`
`sale, sale, and/or importation of the Proposed ANDA Product.
`
`Defendants were aware of the Patents-in-Suit when they submitted ANDA No.
`
`217578 with a Paragraph IV Certification.
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`On information and belief, sodium zirconium cyclosilicate is the active ingredient
`
`in the Proposed ANDA Product.
`
`On information and belief, the Proposed ANDA Product exhibits sodium zirconium
`
`cyclosilicate as patented by the Asserted Patents.
`
`On information and belief, ANDA No. 217578 refers to and relies upon the NDA
`
`for LOKELMA® (sodium zirconium cyclosilicate) for oral suspension 5 g per packet and 10 g per
`
`packet and contains data that, according to Defendants, demonstrate the bioequivalence of the
`
`Proposed ANDA Product and LOKELMA® (sodium zirconium cyclosilicate) for oral suspension
`
`5 g per packet and 10 g per packet. See 21 U.S.C. § 355(j)(2); 21 C.F.R. § 314.94(a)(7).
`
`On information and belief, Defendants intend to have healthcare providers use their
`
`Proposed ANDA Product, if approved, as set forth in the Proposed ANDA Product label. On
`
`information and belief, Defendants’ Proposed ANDA Product label will instruct healthcare
`
`providers to prescribe the Proposed ANDA Product in the manner set forth in the label.
`
`On information and belief, the FDA has not yet approved ANDA No. 217578.
`
`Plaintiffs commenced this action within 45 days of receipt of the Notice Letter.
`
`COUNT I: INFRINGEMENT OF U.S. PATENT NO. 8,802,152
`
`Plaintiffs hereby reallege and incorporate the allegations of paragraphs 1 – 43 of
`
`this Complaint.
`
`On information and belief, the Proposed ANDA Product infringes one or more
`
`claims of the ’152 Patent, either literally or under the doctrine of equivalents, by the use and/or
`
`presence in the Proposed ANDA Product of a sodium zirconium cyclosilicate as covered by one
`
`or more of the claims of the ’152 Patent.
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`Defendants’ submission of ANDA No. 217578 to the FDA under 21 U.S.C. § 355(j)
`
`for the purpose of obtaining approval to commercially manufacture, use, offer for sale, sell, and/or
`
`import the Proposed ANDA Product before the expiration of the ’152 Patent constitutes
`
`infringement of the ’152 Patent under 35 U.S.C. § 271(e)(2).
`
`On information and belief, Defendants plan to, intend to, and will commercially
`
`manufacture, use, offer for sale, sell, and/or import the Proposed ANDA Product immediately
`
`upon approval of ANDA No. 217578 and will instruct healthcare providers to use the Proposed
`
`ANDA Product in accordance with the proposed product labeling.
`
`On information and belief, upon FDA approval of ANDA No. 217578, Defendants
`
`will infringe the ’152 Patent by making, using, offering to sell, selling, and/or importing the
`
`Proposed ANDA Product in the United States, and by actively inducing and/or contributing to
`
`infringement by others under 35 U.S.C. § 271(b) and/or (c).
`
`On information and belief, Defendants had knowledge of the ’152 Patent when they
`
`submitted ANDA No. 217578 to the FDA, Defendants knew or should have known that they will
`
`induce or contribute to another’s direct infringement of the ’152 Patent, and Defendants acted with
`
`the specific intent to induce or contribute to another’s direct infringement of the ’152 Patent.
`
`In the Notice Letter, Defendants do not dispute that the Proposed ANDA Product
`
`infringes one or more claims of the ’152 Patent.
`
`Plaintiffs will be substantially and irreparably harmed by the infringing activities
`
`described above unless those activities are enjoined by this Court. Plaintiffs have no adequate
`
`remedy at law.
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`COUNT II: INFRINGEMENT OF U.S. PATENT NO. 8,808,750
`
`Plaintiffs hereby reallege and incorporate the allegations of paragraphs 1 – 51 of
`
`this Complaint.
`
`On information and belief, the Proposed ANDA Product infringes one or more
`
`claims of the ’750 Patent, either literally or under the doctrine of equivalents, by the use and/or
`
`presence in the Proposed ANDA Product of a sodium zirconium silicate as covered by one or more
`
`of the claims of the ’750 Patent.
`
`Defendants’ submission of ANDA No. 217578 to the FDA under 21 U.S.C. § 355(j)
`
`for the purpose of obtaining approval to commercially manufacture, use, offer for sale, sell, and/or
`
`import the Proposed ANDA Product before the expiration of the ’750 Patent constitutes
`
`infringement of the ’750 Patent under 35 U.S.C. § 271(e)(2).
`
`On information and belief, Defendants plan to, intend to, and will commercially
`
`manufacture, use, offer for sale, sell, and/or import the Proposed ANDA Product immediately
`
`upon approval of ANDA No. 217578 and will instruct healthcare providers to use the Proposed
`
`ANDA Product in accordance with the proposed product labeling.
`
`On information and belief, upon FDA approval of ANDA No. 217578, Defendants
`
`will infringe the ’750 Patent by making, using, offering to sell, selling, and/or importing the
`
`Proposed ANDA Product in the United States, and by actively inducing and/or contributing to
`
`infringement by others under 35 U.S.C. § 271(b) and/or (c).
`
`On information and belief, Defendants had knowledge of the ’750 Patent when they
`
`submitted ANDA No. 217578 to the FDA, Defendants knew or should have known that they will
`
`induce or contribute to another’s direct infringement of the ’750 Patent, and Defendants acted with
`
`the specific intent to induce or contribute to another’s direct infringement of the ’750 Patent.
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`In the Notice Letter, Defendants do not dispute that the Proposed ANDA Product
`
`infringes one or more claims of the ’750 Patent.
`
`Plaintiffs will be substantially and irreparably harmed by the infringing activities
`
`described above unless those activities are enjoined by this Court. Plaintiffs have no adequate
`
`remedy at law.
`
`COUNT III: INFRINGEMENT OF U.S. PATENT NO. 8,877,255
`
`Plaintiffs hereby reallege and incorporate the allegations of paragraphs 1 – 59 of
`
`this Complaint.
`
`On information and belief, the Proposed ANDA Product infringes one or more
`
`claims of the ’255 Patent, either literally or under the doctrine of equivalents, by the use and/or
`
`presence in the Proposed ANDA Product of a sodium zirconium silicate as covered by one or more
`
`of the claims of the ’255 Patent.
`
`Defendants’ submission of ANDA No. 217578 to the FDA under 21 U.S.C. § 355(j)
`
`for the purpose of obtaining approval to commercially manufacture, use, offer for sale, sell, and/or
`
`import the Proposed ANDA Product before the expiration of the ’255 Patent constitutes
`
`infringement of the ’255 Patent under 35 U.S.C. § 271(e)(2).
`
`On information and belief, Defendants plan to, intend to, and will commercially
`
`manufacture, use, offer for sale, sell, and/or import the Proposed ANDA Product immediately
`
`upon approval of ANDA No. 217578 and will instruct healthcare providers to use the Proposed
`
`ANDA Product in accordance with the proposed product labeling.
`
`On information and belief, upon FDA approval of ANDA No. 217578, Defendants
`
`will infringe the ’255 Patent by making, using, offering to sell, selling, and/or importing the
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`Proposed ANDA Product in the United States, and by actively inducing and/or contributing to
`
`infringement by others under 35 U.S.C. § 271(b) and/or (c).
`
`On information and belief, Defendants had knowledge of the ’255 Patent when they
`
`submitted ANDA No. 217578 to the FDA, Defendants knew or should have known that they will
`
`induce or contribute to another’s direct infringement of the ’255 Patent, and Defendants acted with
`
`the specific intent to induce or contribute to another’s direct infringement of the ’255 Patent.
`
`In the Notice Letter, Defendants do not dispute that the Proposed ANDA Product
`
`infringes one or more claims of the ’255 Patent.
`
`Plaintiffs will be substantially and irreparably harmed by the infringing activities
`
`described above unless those activities are enjoined by this Court. Plaintiffs have no adequate
`
`remedy at law.
`
`COUNT IV: INFRINGEMENT OF U.S. PATENT NO. 9,592,253
`
`Plaintiffs hereby reallege and incorporate by reference the allegations of paragraphs
`
`1 – 67 of this Complaint.
`
`On information and belief, the Proposed ANDA Product infringes one or more
`
`claims of the ’253 Patent, either literally or under the doctrine of equivalents, by the use and/or
`
`presence in the Proposed ANDA Product of a sodium zirconium silicate as covered by one or more
`
`of the claims of the ’253 Patent.
`
`Defendants’ submission of ANDA No. 217578 to the FDA under 21 U.S.C. § 355(j)
`
`for the purpose of obtaining approval to commercially manufacture, use, offer for sale, sell, and/or
`
`import the Proposed ANDA Product before the expiration of the ’253 Patent constitutes
`
`infringement of the ’253 Patent under 35 U.S.C. § 271(e)(2).
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`On information and belief, Defendants plan to, intend to, and will commercially
`
`manufacture, use, offer for sale, sell, and/or import the Proposed ANDA Product immediately
`
`upon approval of ANDA No. 217578 and will instruct healthcare providers to use the Proposed
`
`ANDA Product in accordance with the proposed product labeling.
`
`On information and belief, upon FDA approval of ANDA No. 217578, Defendants
`
`will infringe the ’253 Patent by making, using, offering to sell, selling, and/or importing the
`
`Proposed ANDA Product in the United States, and by actively inducing and/or contributing to
`
`infringement by others under 35 U.S.C. § 271(b) and/or (c).
`
`On information and belief, Defendants had knowledge of the ’253 Patent when they
`
`submitted ANDA No. 217578 to the FDA, Defendants knew or should have known that they will
`
`induce or contribute to another’s direct infringement of the ’253 Patent, and Defendants acted with
`
`the specific intent to induce or contribute to another’s direct infringement of the ’253 Patent.
`
`To date, Plaintiffs have not received sufficient information, materials, and things
`
`from Defendants to enable Plaintiffs to meaningfully evaluate the bases for Defendants’ assertion
`
`of non-infringement of the ’253 Patent.
`
`In the absence of the ability to meaningfully evaluate information related to
`
`Defendant’s ANDA No. 217578, Plaintiffs resort to the judicial process and the aid of discovery
`
`to obtain under appropriate judicial safeguards such information as is required to confirm their
`
`belief and to present to the Court evidence that Defendants infringe one or more claims of the ’253
`
`Patent.
`
`Plaintiffs will be substantially and irreparably harmed by the infringing activities
`
`described above unless those activities are enjoined by this Court. Plaintiffs have no adequate
`
`remedy at law.
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`COUNT V: INFRINGEMENT OF U.S. PATENT NO. 9,844,567
`
`Plaintiffs hereby reallege and incorporate by reference the allegations of paragraphs
`
`1 – 76 of this Complaint.
`
`On information and belief, the Proposed ANDA Product infringes one or more
`
`claims of the ’567 Patent, either literally or under the doctrine of equivalents, by the use and/or
`
`presence in the Proposed ANDA Product of a sodium zirconium silicate as covered by one or more
`
`of the claims of the ’567 Patent.
`
`Defendants’ submission of ANDA No. 217578 to the FDA under 21 U.S.C. § 355(j)
`
`for the purpose of obtaining approval to commercially manufacture, use, offer for sale, sell, and/or
`
`import the Proposed ANDA Product before the expiration of the ’567 Patent constitutes
`
`infringement of the ’567 Patent under 35 U.S.C. § 271(e)(2).
`
`On information and belief, Defendants plan to, intend to, and will commercially
`
`manufacture, use, offer for sale, sell, and/or import the Proposed ANDA Product immediately
`
`upon approval of ANDA No. 217578 and will instruct healthcare providers to use the Proposed
`
`ANDA Product in accordance with the proposed product labeling.
`
`On information and belief, upon FDA approval of ANDA No. 217578, Defendants
`
`will infringe the ’567 Patent by making, using, offering to sell, selling, and/or importing the
`
`Proposed ANDA Product in the United States, and by actively inducing and/or contributing to
`
`infringement by others under 35 U.S.C. § 271(b) and/or (c).
`
`On information and belief, Defendants had knowledge of the ’567 Patent when they
`
`submitted ANDA No. 217578 to the FDA, Defendants knew or should have known that they will
`
`induce or contribute to another’s direct infringement of the ’567 Patent, and Defendants acted with
`
`the specific intent to induce or contribute to another’s direct infringement of the ’567 Patent.
`
`ME1 42018715v.1
`
`14
`
`

`

`Case 1:22-cv-01099-UNA Document 1 Filed 08/22/22 Page 15 of 25 PageID #: 15
`
`In the Notice Letter, Defendants do not dispute that the Proposed ANDA Product
`
`infringes one or more claims of the ’567 Patent.
`
`Plaintiffs will be substantially and irreparably harmed by the infringing activities
`
`described above unless those activities are enjoined by this Court. Plaintiffs have no adequate
`
`remedy at law.
`
`COUNT VI: INFRINGEMENT OF U.S. PATENT NO. 9,861,658
`
`Plaintiffs hereby reallege and incorporate by reference the allegations of paragraphs
`
`1 – 84 of this Complaint.
`
`On information and belief, the Proposed ANDA Product infringes one or more
`
`claims of the ’658 Patent, either literally or under the doctrine of equivalents, by the use and/or
`
`presence in the Proposed ANDA Product of a sodium zirconium silicate as covered by one or more
`
`of the claims of the ’658 Patent.
`
`Defendants’ submission of ANDA No. 217578 to the FDA under 21 U.S.C. § 355(j)
`
`for the purpose of obtaining approval to commercially manufacture, use, offer for sale, sell, and/or
`
`import the Proposed ANDA Product before the expiration of the ’658 Patent constitutes
`
`infringement of the ’658 Patent under 35 U.S.C. § 271(e)(2).
`
`On information and belief, Defendants plan to, intend to, and will commercially
`
`manufacture, use, offer for sale, sell, and/or import the Proposed ANDA Product immediately
`
`upon approval of ANDA No. 217578 and will instruct healthcare providers to use the Proposed
`
`ANDA Product in accordance with the proposed product labeling.
`
`On information and belief, upon FDA approval of ANDA No. 217578, Defendants
`
`will infringe the ’658 Patent by making, using, offering to sell, selling, and/or importing the
`
`ME1 42018715v.1
`
`15
`
`

`

`Case 1:22-cv-01099-UNA Document 1 Filed 08/22/22 Page 16 of 25 PageID #: 16
`
`Proposed ANDA Product in the United States, and by actively inducing and/or contributing to
`
`infringement by others under 35 U.S.C. § 271(b) and/or (c).
`
`On information and belief, Defendants had knowledge of the ’658 Patent when they
`
`submitted ANDA No. 217578 to the FDA, Defendants knew or should have known that they will
`
`induce or contribute to another’s direct infringement of the ’658 Patent, and Defendants acted with
`
`the specific intent to induce or contribute to another’s direct infringement of the ’658 Patent.
`
`In the Notice Letter, Defendants do not dispute that the Proposed ANDA Product
`
`infringes one or more claims of the ’658 Patent.
`
`Plaintiffs will be substantially and irreparably harmed by the infringing activities
`
`described above unless those activities are enjoined by this Court. Plaintiffs have no adequate
`
`remedy at law.
`
`COUNT VII: INFRINGEMENT OF U.S. PATENT NO. 9,913,860
`
`Plaintiffs hereby reallege and incorporate by reference the allegations of paragraphs
`
`1 – 92 of this Complaint.
`
`On information and belief, the Proposed ANDA Product infringes one or more
`
`claims of the ’860 Patent, either literally or under the doctrine of equivalents, by the use and/or
`
`presence in the Proposed ANDA Product of a sodium zirconium silicate as covered by one or more
`
`of the claims of the ’860 Patent.
`
`Defendants’ submission of ANDA No. 217578 to the FDA under 21 U.S.C. § 355(j)
`
`for the purpose of obtaining approval to commercially manufacture, use, offer for sale, sell, and/or
`
`import the Proposed ANDA Product before the expiration of the ’860 Patent constitutes
`
`infringement of the ’860 Patent under 35 U.S.C. § 271(e)(2).
`
`ME1 42018715v.1
`
`16
`
`

`

`Case 1:22-cv-01099-UNA Document 1 Filed 08/22/22 Page 17 of 25 PageID #: 17
`
`On information and belief, Defendants plan to, intend to, and will commercially
`
`manufacture, use, offer for sale, sell, and/or import the Proposed ANDA Product immediately
`
`upon approval of ANDA No. 217578 and will instruct healthcare providers to use the Proposed
`
`ANDA Product in accordance with the proposed product labeling.
`
`On information and belief, upon FDA approval of ANDA No. 217578, Defendants
`
`will infringe the ’860 Patent by making, using, offering to sell, selling, and/or importing the
`
`Proposed ANDA Product in the United States, and by actively inducing and/or contributing to
`
`infringement by others under 35 U.S.C. § 271(b) and/or (c).
`
`On information and belief, Defendants had knowledge of the ’860 Patent when they
`
`submitted ANDA No. 217578 to the FDA, Defendants knew or should have known that they will
`
`induce or contribute to another’s direct infringement of the ’860 Patent, and Defendants acted with
`
`the specific intent to induce or contribute to another’s direct infringement of the ’860 Patent.
`
`In the Notice Letter, Defendants do not dispute that the Proposed ANDA Product
`
`infringes one or more claims of the ’860 Patent.
`
`Plaintiffs will be substantially and irreparably harmed by the infringing activities
`
`described above unless those activities are enjoined by this Court. Plaintiffs have no adequate
`
`remedy at law.
`
`COUNT VIII: INFRINGEMENT OF U.S. PATENT NO. 10,300,087
`
`Plaintiffs hereby reallege and incorporate by reference the allegations of paragraphs
`
`1 – 100 of this Complaint.
`
`On information and belief, the Proposed ANDA Product infringes one or more
`
`claims of the ’087 Patent, either literally or under the doctrine of equivalents, by the use and/or
`
`ME1 42018715v.1
`
`17
`
`

`

`Case 1:22-cv-01099-UNA Document 1 Filed 08/22/22 Page 18 of 25 PageID #: 18
`
`presence in the Proposed ANDA Product of a sodium zirconium silicate as covered by one or more
`
`of the claims of the ’087 Patent.
`
`Defendants’ submission of ANDA No. 217578 to the FDA under 21 U.S.C. § 355(j)
`
`for the purpose of obtaining approval to commercially manufacture, use, offer for sale, sell, and/or
`
`import the Proposed ANDA Product before the expiration of the ’087 Patent constitutes
`
`infringement of the ’087 Patent under 35 U.S.C. § 271(e)(2).
`
`On information and belief, Defendants plan to, intend to, and will commercially
`
`manufacture, use, offer for sale, sell, and/or import the Proposed ANDA Product immediately
`
`upon approval of ANDA No. 217578 and will instruct healthcare providers to use the Proposed
`
`ANDA Product in accordance with the proposed product labeling.
`
`On information and belief, upon FDA approval of ANDA No. 217578, Defendants
`
`will infringe the ’087 Patent by making, using, offering to sell, selling, and/or importing the
`
`Proposed ANDA Product in the United States, and by actively inducing and/or contributing to
`
`infringement by others under 35 U.S.C. § 271(b) and/or (c).
`
`On information and belief, Defendants had knowledge of the ’087 Patent when they
`
`submitted ANDA No. 217578 to the FDA, Defendants knew or should have known that they will
`
`induce or contribute to another’s direct infringement of the ’087 Patent, and Defendants acted with
`
`the specific intent to induce or contribute to another’s direct infringement of the ’087 Patent.
`
`In the Notice Letter, Defendants do not dispute that the Proposed ANDA Product
`
`infringes one or more claims of the ’087 Patent.
`
`Plaintiffs will be substantially and irreparably harmed by the infringing activities
`
`described above unless those activities are enjoine

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