throbber
Case 2:22-cv-03186 Document 1 Filed 05/26/22 Page 1 of 33 PageID: 1
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`Keith J. Miller, Esq.
`ROBINSON MILLER LLC
`Ironside Newark
`110 Edison Place, Suite 302
`Newark, New Jersey 07102
`Tel: (973) 690-5400
`Fax: (973) 466-2761
`Email: kmiller@rwmlegal.com
`
`Attorneys for Plaintiffs
`Aragon Pharmaceuticals, Inc., Janssen
`Biotech, Inc., The Regents of the University of
`California, and Sloan-Kettering Institute for
`Cancer Research
`
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF NEW JERSEY
`
`
`
`
`
`
`Civil Action No. ______________________
`
`
`COMPLAINT FOR PATENT
`INFRINGEMENT
`
`(Filed Electronically)
`
`
`ARAGON PHARMACEUTICALS, INC.,
`JANSSEN BIOTECH, INC., THE
`REGENTS OF THE UNIVERSITY OF
`CALIFORNIA, and
`SLOAN-KETTERING INSTITUTE FOR
`CANCER RESEARCH,
`
` Plaintiffs,
`
` v.
`
`
`
`
`
`
`
`
`
`
`
`
`EUGIA PHARMA SPECIALITIES
`LIMITED (A.K.A. EUGIA PHARMA
`SPECIALTIES LIMITED), AUROBINDO
`PHARMA USA, INC., and
`AUROMEDICS PHARMA LLC,
`
` Defendants.
`
`
`
`
`
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`
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`

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`Case 2:22-cv-03186 Document 1 Filed 05/26/22 Page 2 of 33 PageID: 2
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`Plaintiffs Aragon Pharmaceuticals, Inc. (“Aragon”), Janssen Biotech, Inc. (“JBI”), The
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`Regents of the University of California (“Regents”), and Sloan-Kettering Institute for Cancer
`
`Research (“Sloan-Kettering”) (collectively, “Plaintiffs”), for their Complaint against Defendants
`
`Eugia Pharma Specialities Limited (also known as Eugia Pharma Specialties Limited) (“Eugia”),
`
`Aurobindo Pharma USA, Inc. (“Aurobindo”), and AuroMedics Pharma LLC (“AuroMedics”)
`
`(collectively, “Defendants”), hereby allege as follows:
`
`NATURE OF THE ACTION
`
`1.
`
`This is a civil action for infringement of United States Patent Nos. 8,445,507 (“the
`
`507 Patent”), 8,802,689 (“the 689 Patent”), 9,388,159 (“the 159 Patent”), 9,481,663 (“the 663
`
`Patent”), and 9,987,261 (“the 261 Patent”) (collectively, the “Patents-In-Suit”).
`
`2.
`
`This action relates to the submission of Abbreviated New Drug Application No.
`
`217104 (“the ANDA”) by Defendants to the United States Food and Drug Administration
`
`(“FDA”) seeking approval to market a proposed generic version of Erleada® (“Proposed ANDA
`
`Product”) prior to the expiration of the Patents-In-Suit.
`
`THE PARTIES
`
`3.
`
`Aragon is a corporation organized and existing under the laws of the State of
`
`Delaware, having its principal place of business at 10990 Wilshire Boulevard, Suite 440,
`
`Los Angeles, California 90024.
`
`4.
`
`JBI is a corporation organized and existing under the laws of the Commonwealth
`
`of Pennsylvania, having its principal place of business at 800/850 Ridgeview Drive, Horsham,
`
`Pennsylvania 19044.
`
`
`
`2
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`

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`5.
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`Regents is a California non-profit constitutional corporation and the governing
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`body of an educational institution, having its principal place of business at 1111 Franklin Street,
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`Oakland, California 94607.
`
`6.
`
`Sloan-Kettering is a corporation organized and existing under the laws of the
`
`State of New York, having its principal place of business at 1275 York Avenue, New York, New
`
`York 10065.
`
`7.
`
`On information and belief, Eugia is a corporation organized under the laws of
`
`India, having its principal place of business at either its registered office at Maitrivihar, Plot #2,
`
`Ameerpet, Hyderabad, Telangana 500038, India (“Maitrivihar” address) or its corporate office at
`
`Galaxy, Floors: 22-24, Plot No.1, Sy No.83/1, Hyderabad Knowledge City, Raidurg Panmaktha,
`
`Hyderabad, Telangana 500032, India (“Galaxy” address).
`
`8.
`
`On information and belief, Eugia has on some occasions identified itself as Eugia
`
`Pharma “Specialities,” and on other occasions as Eugia Pharma “Specialties,” including, for
`
`example, in Answers that Eugia filed in the following cases: Pfizer Inc. et al. v. Aurobindo
`
`Pharma, Ltd. et al., No. 20-cv-01528, Answer (D. Del. Dec 4, 2020) (“Eugia Pharma Specialities
`
`Ltd.”; principal place of business at the “Maitrivihar” address), Medicure International, Inc. v.
`
`Aurobindo Pharma Limited et al., No. 2:21-cv-17534, Answer (D.N.J. Feb. 16, 2022) (“Eugia
`
`Pharma Specialties Limited”; principal place of business at the “Galaxy” address), and Amgen
`
`Inc. et al. v. Aurobindo Pharma Ltd. et al., No. 22-cv-00227, Answer (D. Del. Mar 17, 2022)
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`(“Eugia Pharma Specialties Limited”; principal place of business at the “Maitrivihar” address).
`
`9.
`
`On information and belief, Aurobindo is a corporation organized and existing
`
`under the laws of the State of Delaware, having a principal place of business at 279 Princeton-
`
`Hightstown Rd, East Windsor, NJ 08520.
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`
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`3
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`10.
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`On information and belief, AuroMedics is a corporation organized under the laws
`
`of the State of Delaware, having its principal place of business at 279 Princeton-Hightstown Rd,
`
`East Windsor, NJ 08520.
`
`JURISDICTION AND VENUE
`
`11.
`
`This is an action for patent infringement arising under the Patent Laws of the
`
`United States, 35 U.S.C. § 100 et seq., including § 271(e)(2), and also including an action
`
`seeking declaratory judgment pursuant to the Declaratory Judgment Act, 28 U.S.C. §§ 2201-02
`
`for patent infringement arising under 35 U.S.C. § 100 et seq., including § 271(a)-(c).
`
`12.
`
`This Court has jurisdiction over the subject matter of this action pursuant to 28
`
`U.S.C. §§ 1331 and 1338(a).
`
`13.
`
`Venue is proper in this judicial district pursuant to 28 U.S.C. §§ 1391 and
`
`1400(b).
`
`14.
`
`On information and belief, Defendants cooperate, collaborate, or act in concert for
`
`the purposes of manufacturing, selling, marketing, distributing, and importing generic drug
`
`products in New Jersey and throughout the United States.
`
`15.
`
`On information and belief, Eugia has substantial, continuous, and systematic
`
`contacts with New Jersey.
`
`16.
`
`On information and belief, Eugia develops, manufactures, markets, and distributes
`
`pharmaceutical products, including generic pharmaceutical products, for sale in the State of New
`
`Jersey and throughout the United States.
`
`17.
`
`On information and belief, Eugia, alone or together with Aurobindo and/or
`
`AuroMedics, has committed, or aided, abetted, actively induced, contributed to, or participated in
`
`the commission of an act of patent infringement under 35 U.S.C. § 271(e)(2) that has led or will
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`
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`4
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`
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`lead to foreseeable harm and injury to Plaintiffs throughout the United States, including in New
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`Jersey.
`
`18.
`
`On information and belief, Eugia consented to jurisdiction, did not contest
`
`jurisdiction, or asserted counterclaims in New Jersey in one or more prior litigations, for
`
`example: Medicure International, Inc. v. Aurobindo Pharma Limited et al., No. 2:21-cv-17534;
`
`Celgene Corporation v. Aurobindo Pharma Ltd. et al., No. 2:21-cv-00624; Celgene Corporation
`
`v. Aurobindo Pharma Ltd. et al., No. 2:20-cv-00315; Celgene Corporation v. Aurobindo Pharma
`
`Limited et al., No. 2:19-cv-05799; Celgene Corporation v. Aurobindo Pharma Limited et al., No.
`
`2:19-cv-00143; Celgene Corporation v. Hetero Labs Limited et al., No. 2:17-cv-03387.
`
`19.
`
`This Court has personal jurisdiction over Eugia by virtue of, among other things,
`
`(1) its continuous and systematic contacts with New Jersey; (2) its acts of patent infringement
`
`that will result in foreseeable harm in New Jersey; (3) its sale of a substantial volume of
`
`prescription drugs in New Jersey; and (4) its conduct by and through, and in concert with,
`
`Aurobindo and/or AuroMedics.
`
`20.
`
`This Court has personal jurisdiction over Eugia because, inter alia, this action
`
`arises from actions of Eugia directed toward New Jersey. For example, Defendants submitted
`
`the ANDA seeking approval to commercially manufacture, use, sell, offer for sale, or import the
`
`Proposed ANDA Product prior to the expiration of the Patents-In-Suit. If FDA approval is
`
`obtained, the Proposed ANDA Product would be sold in New Jersey, causing injury to Plaintiffs
`
`in New Jersey.
`
`21.
`
`Exercising personal jurisdiction over Eugia in this district would not be
`
`unreasonable given Eugia’s contacts in this district and the interest in this district of resolving
`
`disputes related to products to be sold herein.
`
`
`
`5
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`22.
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`In the alternative, this Court has personal jurisdiction over Eugia because the
`
`requirements of Federal Rule of Civil Procedure 4(k)(2)(A) are met: (a) Plaintiffs’ claims arise
`
`under federal law; (b) Eugia is a foreign defendant not subject to personal jurisdiction in the
`
`courts of any State; and (c) Eugia has sufficient contacts with the United States as a whole,
`
`including, but not limited to, filing Abbreviated New Drug Applications with the FDA and
`
`manufacturing and selling generic pharmaceutical products that are distributed throughout the
`
`United States, such that this Court’s exercise of jurisdiction over Eugia satisfies due process, and
`
`is consistent with the United States Constitution and Laws.
`
`23.
`
`Venue is proper under 28 U.S.C. § 1391(c)(3) because Eugia is a foreign
`
`corporation.
`
`24.
`
`On information and belief, AuroMedics has substantial, continuous, and
`
`systematic contacts with New Jersey.
`
`25.
`
`On information and belief, AuroMedics develops, manufactures, markets, and
`
`distributes pharmaceutical products, including generic pharmaceutical products, for sale in the
`
`State of New Jersey and throughout the United States.
`
`26.
`
`On information and belief, AuroMedics has substantial, continuous, and
`
`systematic contacts with New Jersey, including that it is registered to do business in New Jersey
`
`(Entity Id. No. 0400485691) and is registered as a drug manufacturer and drug wholesaler in
`
`New Jersey (Registration No. 5004299).
`
`27.
`
`On information and belief, AuroMedics has a regular and established business at
`
`279 Princeton-Hightstown Rd, East Windsor, NJ 08520.
`
`28.
`
`On information and belief, AuroMedics, alone or together with Aurobindo and/or
`
`Eugia, has committed, or aided, abetted, actively induced, contributed to, or participated in the
`
`
`
`6
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`
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`commission of an act of patent infringement under 35 U.S.C. § 271(e)(2) that has led or will lead
`
`to foreseeable harm and injury to Plaintiffs throughout the United States, including in New
`
`Jersey.
`
`29.
`
`On information and belief, AuroMedics consented to jurisdiction, did not contest
`
`jurisdiction, or asserted counterclaims in New Jersey in one or more prior litigations, for
`
`example: Medicure International, Inc. v. Aurobindo Pharma Limited et al., No. 2:21-cv-17534;
`
`Merck Sharp & Dohme Corp. v. Aurobindo Pharma USA, Inc. et al., No. 3:20-cv-10444.
`
`30.
`
`This Court has personal jurisdiction over AuroMedics by virtue of, among other
`
`things, (1) its continuous and systematic contacts with New Jersey; (2) its acts of patent
`
`infringement that will result in foreseeable harm in New Jersey; (3) its sale of a substantial
`
`volume of prescription drugs in New Jersey; and (4) its conduct by and through, and in concert
`
`with, Aurobindo and/or Eugia.
`
`31.
`
`This Court has personal jurisdiction over AuroMedics because, inter alia, this
`
`action arises from actions of AuroMedics directed toward New Jersey. For example, Defendants
`
`submitted the ANDA seeking approval to commercially manufacture, use, sell, offer for sale, or
`
`import the Proposed ANDA Product prior to the expiration of the Patents-In-Suit. If FDA
`
`approval is obtained, the Proposed ANDA Product would be sold in New Jersey, causing injury
`
`to Plaintiffs in New Jersey.
`
`32.
`
`Exercising personal jurisdiction over AuroMedics in this district would not be
`
`unreasonable given AuroMedics’s contacts in this district and the interest in this district of
`
`resolving disputes related to products to be sold herein.
`
`33.
`
`On information and belief, AuroMedics has committed an act of infringement in
`
`this judicial district by submitting the ANDA with the FDA on or about February 14, 2022.
`
`
`
`7
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`34.
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`On information and belief, Defendants are cooperating, collaborating, or acting in
`
`concert with each other with respect to formulating, manufacturing, packaging, marketing, or
`
`selling with respect to the Proposed ANDA Product.
`
`35.
`
`On information and belief, AuroMedics has committed acts or caused acts to be
`
`committed in preparation for and submission of the ANDA in this judicial district.
`
`36.
`
`On information and belief, AuroMedics will directly benefit if the ANDA is
`
`approved by participating in the distribution, offer for sale, or sale of the Proposed ANDA
`
`Product.
`
`37.
`
`Venue is proper under 28 U.S.C. § 1400(b) because AuroMedics has committed
`
`an act of infringement and has a regular and established place of business in this judicial district.
`
`38.
`
`On information and belief, Aurobindo has substantial, continuous, and systematic
`
`contacts with New Jersey.
`
`39.
`
`On information and belief, Aurobindo develops, manufactures, markets, and
`
`distributes pharmaceutical products, including generic pharmaceutical products, for sale in the
`
`State of New Jersey and throughout the United States.
`
`40.
`
`On information and belief, Aurobindo has substantial, continuous, and systematic
`
`contacts with New Jersey, including that it is registered to do business in New Jersey (Entity Id.
`
`No. 01000921223) and is registered as a drug wholesaler in New Jersey (Registration No.
`
`5005256).
`
`41.
`
`On information and belief, Aurobindo has a regular and established business at
`
`279 Princeton-Hightstown Rd, East Windsor, NJ 08520. On information and belief, Aurobindo
`
`has a regular and established business at 203 Windsor Center Dr, East Windsor, NJ 08520 and
`
`has registered this address with the New Jersey Department of Health.
`
`
`
`8
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`42.
`
`On information and belief, Aurobindo, alone or together with Eugia and/or
`
`AuroMedics, has committed, or aided, abetted, actively induced, contributed to, or participated in
`
`the commission of an act of patent infringement under 35 U.S.C. § 271(e)(2) that has led or will
`
`lead to foreseeable harm and injury to Plaintiffs throughout the United States, including in New
`
`Jersey.
`
`43.
`
`On information and belief, Aurobindo consented to jurisdiction, did not contest
`
`jurisdiction, or asserted counterclaims in New Jersey in one or more prior litigations, for
`
`example: Medicure International, Inc. v. Aurobindo Pharma Limited et al., No. 2:21-cv-17534;
`
`Celgene Corporation v. Aurobindo Pharma Ltd. et al., No. 2:21-cv-00624; Merck Sharp &
`
`Dohme Corp. v. Aurobindo Pharma USA, Inc. et al., No. 3:20-cv-10444; Celgene Corporation v.
`
`Aurobindo Pharma Ltd. et al., No. 2:20-cv-00315; Celgene Corporation v. Aurobindo Pharma
`
`Limited et al., No. 2:19-cv-05799; Celgene Corporation v. Aurobindo Pharma Limited et al., No.
`
`2:19-cv-00143; Celgene Corporation v. Hetero Labs Limited et al., No. 2:17-cv-03387.
`
`44.
`
`This Court has personal jurisdiction over Aurobindo by virtue of, among other
`
`things, (1) its continuous and systematic contacts with New Jersey; (2) its acts of patent
`
`infringement that will result in foreseeable harm in New Jersey; (3) its sale of a substantial
`
`volume of prescription drugs in New Jersey; and (4) its conduct by and through, and in concert
`
`with, Eugia and/or AuroMedics.
`
`45.
`
`This Court has personal jurisdiction over Aurobindo because, inter alia, this
`
`action arises from actions of Aurobindo directed toward New Jersey. For example, Defendants
`
`submitted the ANDA seeking approval to commercially manufacture, use, sell, offer for sale, or
`
`import the Proposed ANDA Product prior to the expiration of the Patents-In-Suit. If FDA
`
`
`
`9
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`
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`approval is obtained, the Proposed ANDA Product would be sold in New Jersey, causing injury
`
`to Plaintiffs in New Jersey.
`
`46.
`
`Exercising personal jurisdiction over Aurobindo in this district would not be
`
`unreasonable given Aurobindo’s contacts in this district and the interest in this district of
`
`resolving disputes related to products to be sold herein.
`
`47.
`
`On information and belief, Aurobindo has committed an act of infringement in
`
`this judicial district by submitting the ANDA with the FDA on or about February 14, 2022.
`
`48.
`
`On information and belief, Defendants are cooperating, collaborating, or acting in
`
`concert with each other with respect to formulating, manufacturing, packaging, marketing, or
`
`selling with respect to the Proposed ANDA Product.
`
`49.
`
`On information and belief, Aurobindo has committed acts or caused acts to be
`
`committed in preparation for and submission of the ANDA in this judicial district.
`
`50.
`
`On information and belief, Aurobindo will directly benefit if the ANDA is
`
`approved by participating in the distribution, offer for sale, or sale of the Proposed ANDA
`
`Product.
`
`51.
`
`Venue is proper under 28 U.S.C. § 1400(b) because Aurobindo has committed an
`
`act of infringement and has a regular and established place of business in this judicial district.
`
`ERLEADA®
`
`52.
`
`JBI holds approved New Drug Application No. 210951 for apalutamide, which is
`
`prescribed and sold as Erleada®.
`
`53.
`
`On information and belief, Defendants know that JBI holds approved New Drug
`
`Application No. 210951.
`
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`10
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`54.
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`Erleada® is indicated for the treatment of patients with non-metastatic castration-
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`resistant prostate cancer and metastatic castration-sensitive prostate cancer. Erleada® is supplied
`
`as tablets for oral administration containing the active pharmaceutical ingredient apalutamide.
`
`55.
`
`The International Union of Pure and Applied Chemistry (IUPAC) name for
`
`apalutamide is 4-[7-(6-Cyano-5-trifluoromethylpyridin-3-yl)-8-oxo-6-thioxo-5,7-
`
`diazaspiro[3.4]oct-5-yl]-2-fluoro-N-methylbenzamide.
`
`THE PATENTS-IN-SUIT
`
`56.
`
`On May 21, 2013, the 507 Patent, titled “Androgen Receptor Modulator for the
`
`Treatment of Prostate Cancer and Androgen Receptor-Associated Diseases” was duly and legally
`
`issued to Regents as assignee. A copy of the 507 Patent is attached as Exhibit A.
`
`57.
`
`On August 12, 2014, the 689 Patent, titled “Androgen Receptor Modulator for the
`
`Treatment of Prostate Cancer and Androgen Receptor-Associated Diseases” was duly and legally
`
`issued to Regents as assignee. A copy of the 689 Patent is attached as Exhibit B.
`
`58.
`
`On July 12, 2016, the 159 Patent, titled “Substituted Diazaspiroalkanes as
`
`Androgen Receptor Modulators” was duly and legally issued to Regents as assignee. A copy of
`
`the 159 Patent is attached as Exhibit C.
`
`59.
`
`On November 1, 2016, the 663 Patent, titled “Crystalline Forms of an Androgen
`
`Receptor Modulator” was duly and legally issued to Aragon and Sloan-Kettering as assignees. A
`
`copy of the 663 Patent is attached as Exhibit D.
`
`60.
`
`On June 5, 2018, the 261 Patent, titled “Substituted Diazaspiroalkanes as
`
`Androgen Receptor Modulators” was duly and legally issued to Regents as assignee. A copy of
`
`the 261 Patent is attached as Exhibit E.
`
`
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`11
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`61.
`
`Pursuant to 21 U.S.C. § 355(b)(1), the Patents-In-Suit are listed in the FDA
`
`publication titled Approved Drug Products with Therapeutic Equivalence Evaluations (also
`
`known as the “Orange Book”) as covering Erleada®.
`
`62.
`
`On information and belief, Defendants know that the Patents-In-Suit are listed in
`
`the Orange Book as covering Erleada®.
`
`DEFENDANTS’ NOTICE LETTER AND THE ANDA
`
`63.
`
`By letter dated April 16, 2022, addressed to JBI, Sloan-Kettering, Aragon, and
`
`Regents (“Notice Letter”), Defendants notified Plaintiffs that they had submitted ANDA No.
`
`217104 to the FDA under § 505(j)(2) of the Federal Food, Drug and Cosmetic Act (21 U.S.C.
`
`§ 355(j)). The Notice Letter stated that the ANDA seeks the FDA approval necessary to engage
`
`in activities that constitute or require the commercial manufacture, use, sale, offer for sale in, or
`
`importation into the United States, of the Proposed ANDA Product, described in the Notice
`
`Letter as “Apalutamide tablets, 60 mg” prior to the expiration of the Patents-In-Suit.
`
`64.
`
`The Notice Letter stated that “Eugia Pharma Specialties Limited and U.S. Agent
`
`AuroMedics Pharma LLC” were providing notice in relation to the submission of the ANDA.
`
`65.
`
`On information and belief, Aurobindo is a U.S. Agent connected to the filing of
`
`the ANDA.
`
`66.
`
`The Notice Letter did not cite section 505(j)(2)(B)(iv) of the Federal Food, Drug,
`
`and Cosmetic Act, despite the requirement to do so under 21 C.F.R. § 314.95(c).
`
`67.
`
`The Notice Letter did not state that Defendants had received a Paragraph IV
`
`acknowledgement letter from the FDA, despite the requirement to do so under 21 C.F.R.
`
`§ 314.95(c)(3).
`
`
`
`12
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`68.
`
`The ANDA includes a Paragraph IV Certification that the claims of the Patents-
`
`In-Suit are invalid, unenforceable, or not infringed.
`
`69.
`
`The Notice Letter stated that the Proposed ANDA Product will not infringe the
`
`claims of the 663 Patent because the Proposed ANDA Product does not contain crystalline Form
`
`B of apalutamide.
`
`70.
`
`The Notice Letter included an Offer for Confidential Access (“OCA”) to the
`
`ANDA.
`
`71.
`
`The OCA referred to a drug called “pomalidomide” but did not refer to
`
`apalutamide.
`
`72.
`
`Counsel for Plaintiffs telephoned and/or emailed counsel for Defendants
`
`regarding the OCA on at least April 26, April 28, April 29, May 2, May 9, and May 11, but
`
`counsel for Defendants did not respond until the evening of May 11.
`
`73.
`
`On May 19, 2022, Defendants produced documents that Defendants purported to
`
`be the ANDA.
`
`74.
`
`On May 23, 2022, Plaintiffs requested technical information regarding the
`
`Proposed ANDA Product. Defendants did not respond. By failing to provide information,
`
`Defendants impeded Plaintiffs’ ability to evaluate infringement of the 663 Patent. On
`
`information and belief, if Defendants had a good faith basis to contest infringement of the 663
`
`Patent, they would have provided the requested information.
`
`75.
`
`Plaintiffs are not aware of any other means by which to obtain technical
`
`information regarding the Proposed ANDA Product.
`
`76.
`
`On information and belief, the Proposed ANDA Product contains some amount of
`
`crystalline Form B of apalutamide.
`
`
`
`13
`
`

`

`Case 2:22-cv-03186 Document 1 Filed 05/26/22 Page 14 of 33 PageID: 14
`
`
`
`77.
`
`On information and belief, the drug substance in and used for the Proposed
`
`ANDA Product contains some amount of crystalline Form B of apalutamide.
`
`78.
`
`Plaintiffs are commencing this action within 45 days of the date of receipt of the
`
`Notice Letter.
`
`COUNT I – CLAIM FOR INFRINGEMENT OF THE 507
`PATENT
`
`79.
`
`80.
`
`Plaintiffs re-allege each of the foregoing paragraphs as if fully set forth herein.
`
`An actual controversy exists between the parties as to whether Defendants’
`
`proposed sale of the Proposed ANDA Product infringes the claims of the 507 Patent, including at
`
`least claims 1, 2, 3, 11, 19, and 22.
`
`81.
`
`On information and belief, because the Proposed ANDA Product contains
`
`apalutamide, the Proposed ANDA Product and the use of the Proposed ANDA Product infringe
`
`at least claims 1, 2, 3, 11, 19, and 22 of the 507 Patent.
`
`82.
`
`On information and belief, the Proposed ANDA Product infringes at least claims 1
`
`and 22 of the 507 Patent because it contains the compound apalutamide.
`
`83.
`
`On information and belief, the Proposed ANDA Product infringes at least claims 2
`
`and 11 of the 507 Patent because it is a pharmaceutical composition comprising a therapeutically
`
`effective amount of the compound apalutamide and a pharmaceutically acceptable carrier,
`
`diluent, or adjuvant.
`
`84.
`
`On information and belief, the use of the Proposed ANDA Product will infringe at
`
`least claims 3 and 19 of the 507 Patent because physicians and/or patients will practice a method
`
`for treating a hyperproliferative disorder, specifically prostate cancer, said method comprising
`
`administering, causing to be administered, or directing the administration of the compound
`
`
`
`14
`
`

`

`Case 2:22-cv-03186 Document 1 Filed 05/26/22 Page 15 of 33 PageID: 15
`
`
`
`apalutamide to a subject, specifically a patient, in need of such treatment, thereby treating the
`
`prostate cancer.
`
`85.
`
`On information and belief, Defendants will induce infringement of at least claims
`
`3 and 19 of the 507 Patent by actively inducing the use of the Proposed ANDA Product to
`
`practice a method for treating a hyperproliferative disorder, specifically prostate cancer, said
`
`method comprising administering, causing to be administered, or directing the administration of
`
`the compound apalutamide to a subject, specifically a patient, in need of such treatment, thereby
`
`treating the prostate cancer.
`
`86.
`
`On information and belief, if the FDA approves the ANDA, Defendants will sell
`
`or offer to sell the Proposed ANDA Product specifically labeled for use in practicing the claims
`
`of the 507 Patent, including at least claims 1, 2, 3, 11, 19, and 22, wherein the Proposed ANDA
`
`Product is a material part of the claimed invention, wherein Defendants know that physicians
`
`will prescribe and patients will use the Proposed ANDA Product in accordance with the
`
`instructions or label provided by Defendants in practicing the claims of the 507 Patent, including
`
`at least claims 1, 2, 3, 11, 19, and 22, and wherein the Proposed ANDA Product is not a staple
`
`article or commodity of commerce suitable for substantial non-infringing use.
`
`87.
`
`The Notice Letter purports to include a Notice of Certification for the ANDA
`
`under 37 C.F.R. § 314.95(c)(6) as to the 507 Patent. The Notice Letter did not include a detailed
`
`and supported statement of allegations of invalidity, unenforceability, or non-infringement for
`
`every claim of the 507 Patent.
`
`88.
`
`On information and belief, Defendants have actual knowledge of the 507 Patent,
`
`at least as shown by the Notice Letter.
`
`
`
`15
`
`

`

`Case 2:22-cv-03186 Document 1 Filed 05/26/22 Page 16 of 33 PageID: 16
`
`
`
`89.
`
`On information and belief, under 35 U.S.C. § 271(e)(2)(A), Defendants have
`
`infringed the claims of the 507 Patent, including at least claims 1, 2, 3, 11, 19, and 22, by
`
`submitting or causing to be submitted to the FDA, the ANDA seeking approval to manufacture,
`
`use, import, offer to sell or sell the Proposed ANDA Product before the expiration date of the
`
`507 Patent.
`
`90.
`
`On information and belief, the Proposed ANDA Product and its use, if approved
`
`and marketed, will infringe, either literally or under the doctrine of equivalents, at least one claim
`
`of the 507 Patent, including at least claims 1, 2, 3, 11, 19, and 22, under at least one of 35 U.S.C.
`
`§ 271(a), (b), or (c).
`
`91.
`
`On information and belief, the manufacture, use, import, offer to sell, or sale of
`
`the Proposed ANDA Product will directly infringe the claims of the 507 Patent, including at least
`
`claims 1, 2, 3, 11, 19, and 22.
`
`92.
`
`On information and belief, physicians and/or patients will directly infringe the
`
`claims of the 507 Patent, including at least claims 1, 2, 3, 11, 19, and 22, by their use of the
`
`Proposed ANDA Product upon approval.
`
`93.
`
`On information and belief, upon approval, Defendants will take active steps to
`
`encourage the use of the Proposed ANDA Product by physicians and/or patients with the
`
`knowledge and intent that the Proposed ANDA Product will be used by physicians and/or
`
`patients, in a manner that infringes the claims of the 507 Patent, including at least claims 1, 2, 3,
`
`11, 19, and 22, for the pecuniary benefit of Defendants.
`
`94.
`
`On information and belief, Defendants specifically intend the Proposed ANDA
`
`Product to be used in a manner that infringes the claims of the 507 Patent, including at least
`
`
`
`16
`
`

`

`Case 2:22-cv-03186 Document 1 Filed 05/26/22 Page 17 of 33 PageID: 17
`
`
`
`claims 1, 2, 3, 11, 19, and 22. On information and belief, Defendants will actively induce the
`
`infringement of the claims of the 507 Patent, including at least claims 1, 2, 3, 11, 19, and 22.
`
`95.
`
`On information and belief, the Proposed ANDA Product is specifically designed
`
`for use in a manner that infringes the claims of the 507 Patent, including at least claims 1, 2, 3,
`
`11, 19, and 22. On information and belief, Defendants will thus contribute to the infringement of
`
`the claims of the 507 Patent, including at least claims 1, 2, 3, 11, 19, and 22.
`
`96.
`
`On information and belief, the actions described in this Complaint relating to the
`
`ANDA and the 507 Patent were done by and for the benefit of Defendants.
`
`97.
`
`Plaintiffs will be irreparably harmed by these infringing activities unless those
`
`activities are enjoined by this Court. Plaintiffs do not have an adequate remedy at law.
`
`COUNT II – CLAIM FOR INFRINGEMENT OF THE 689
`PATENT
`
`98.
`
`99.
`
`Plaintiffs re-allege each of the foregoing paragraphs as if fully set forth herein.
`
`An actual controversy exists between the parties as to whether Defendants’
`
`proposed sale of the Proposed ANDA Product infringes the claims of the 689 Patent, including at
`
`least claim 2.
`
`100. On information and belief, because the Proposed ANDA Product contains
`
`apalutamide, the use of the Proposed ANDA Product infringes at least claim 2 of the 689 Patent.
`
`101. On information and belief, the use of the Proposed ANDA Product will infringe at
`
`least claim 2 of the 689 Patent because physicians and/or patients will practice a method for
`
`treating prostate cancer in a subject, specifically a patient, said method comprising
`
`administering, causing to be administered, or directing the administration of the compound
`
`apalutamide to the patient in need of such treatment.
`
`
`
`17
`
`

`

`Case 2:22-cv-03186 Document 1 Filed 05/26/22 Page 18 of 33 PageID: 18
`
`
`
`102. On information and belief, Defendants will induce infringement of at least claim 2
`
`of the 689 Patent by actively inducing the use of the Proposed ANDA Product to practice a
`
`method for treating prostate cancer in a subject, specifically a patient, said method comprising
`
`administering, causing to be administered, or directing the administration of the compound
`
`apalutamide to the patient in need of such treatment.
`
`103. On information and belief, if the FDA approves the ANDA, Defendants will sell
`
`or offer to sell the Proposed ANDA Product specifically labeled for use in practicing the claims
`
`of the 689 Patent, including at least claim 2, wherein the Proposed ANDA Product is a material
`
`part of the claimed invention, wherein Defendants know that physicians will prescribe and
`
`patients will use the Proposed ANDA Product in accordance with the instructions or label
`
`provided by Defendants in practicing the claims of the 689 Patent, including at least claim 2, and
`
`wherein the Proposed ANDA Product is not a staple article or commodity of commerce suitable
`
`for substantial non-infringing use.
`
`104. The Notice Letter purports to include a Notice of Certification for the ANDA
`
`under 37 C.F.R. § 314.95(c)(6) as to the 689 Patent. The Notice Letter did not include a detailed
`
`and supported statement of allegations of invalidity, unenforceability, or non-infringement for
`
`every claim of the 689 Patent.
`
`105. On information and belief, Defendants have actual knowledge of 689 Patent, at
`
`least as shown by the Notice Letter.
`
`106. On information and belief, under 35 U.S.C. § 271(e)(2)(A), Defendants have
`
`infringed the claims of the 689 Patent, including at least claim 2, by submitting or causing to be
`
`submitted to the FDA, the ANDA seeking approval to manufacture, use, import, offer to sell or
`
`sell the Proposed ANDA Product before the expiration date of the 689 Patent.
`
`
`
`18
`
`

`

`Case 2:22-cv-03186 Document 1 F

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