Case 1:14-cv-01058-LPS Document 1 Filed 08/15/14 Page 1 of 20 PageID #: 1
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`IN THE UNITED STATES DISTRICT COURT
`
`FOR THE DISTRICT OF DELAWARE
`
`FOREST LABORATORIES, LLC, FOREST
`LABORATORIES HOLDINGS, LTD., and
`ADAMAS PHARMACEUTICALS, INC.,
`
`Plaintiffs,
`
`v.
`
`LUPIN LIMITED, LUPIN
`PHARMACEUTICALS, INC., PAR
`PHARMACEUTICAL, INC., ANCHEN
`PHARMACEUTICALS, INC., AMERIGEN
`PHARMACEUTICALS, INC., and
`AMERIGEN PHARMACEUTICALS LTD.,
`
`Defendants.
`
`C.A. N0.
`
`\._I\._/\..J\./V-../\-./\./‘&'\i'\—/\—/\-.—f\-—¥‘u_-/\-—J\_/
`
`COMPLAINT
`
`Plaintiffs Forest Laboratories, LLC (f/k/a Forest Laboratories, Inc.), Forest Laboratories
`
`Holdings, Ltd., and Adamas Pharmaceuticals, Inc. (collectively, "Plaintiffs"), for their Complaint
`
`against Defendants Lupin Limited, Lupin Pharmaceuticals,
`
`Inc'., Par Pharmaceutical,
`
`Inc.,
`
`Anchen Pharmaceuticals, Inc., Amerigen Pharmaceuticals, Inc., and Arnerigen Pharmaceuticals
`
`Ltd. (collectively, "Defendant-s"), hereby allege as follows.
`
`PARTIES
`
`1.
`
`Plaintiff Forest Laboratories, LLC (f/k/a Forest Laboratories, Inc.) is a Delaware
`
`limited liability company having a principal place of business at Morris Corporate Center III,
`
`400 lnterpace Parkway, Parsippany, New Jersey 07054.
`
`2.
`
`Plaintiff" Forest "Laboratories Holdings, Ltd.
`
`-is an Irish corporation having a
`
`principal place of business at Columbia House,
`
`1 Victoria Street, Hamilton HM11, Bermuda
`
`(referred to herein, together with Forest Laboratories, Inc., as "Fcrest").
`
`

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`3.
`
`Plaintiff Adamas Pharmaceuticals, Inc. ("Adarnas") is a Delaware corporation
`
`having a principal place of business at 2200 Powell Street, Suite 220, Emeryville, Califom-ia
`
`94608.
`
`4.
`
`Upon information and belief, Defendant Lupin Limited is an Indian corporation
`
`having a principal place of business at B/4 Laxmi Towers, Bandra Kurla Complex, Bandra
`
`(East), Mumbai, Maharashtra 400 051, India. Upon information and belief, Defendant Lupin
`
`Limited manufactures and/or distributes numerous generic drugs for sale and use throughout the
`
`United States, including in this judicial district, and including through its subsidiary and agent
`
`Lupin Pharmaceuticals, Inc.
`
`5.
`
`Upon information and belief, Defendant Lupin Pharmaceuticals, Inc. is a Virginia
`
`corporation having a principal place of business at Harborplace Tower, 111 South Calvert Street,
`
`21st Floor, Baltimore, Maryland 21202. Upon information and belief, Defendant Lupin
`
`Pharmaceuticals, Inc. (referred to herein, together with Lupin Limited, as "Lupin") manufactures
`
`and/or distributes numerous generic drugs for sale and use throughout the United States,
`
`including in this _judicial district, and including as a subsidiary and agent of Lupin Limited.
`
`6.
`
`Upon information -and belief, Defendant Par Pharmaceutical, Inc. ("Par") is a
`
`Delaware corporation having a principal place of business at One Ram Ridge Road, Spring
`
`Valley, NY 10977.
`
`Upon information and belief, Defendant Par Pharmaceutical,
`
`Inc.
`
`manufactures and/or -distributes numerous generic drugs for sale and use throughout the United
`
`States, including in this judicial district, and including through its subsidiary and agent Anchen
`
`Pharmaceuticals, Inc.
`
`7.
`
`Upon information and belief, Defendant Anchen Pharmaceuticals,
`
`Inc.
`
`("Anchen") is a California corporation having a principal place of business at 9601 Jeronimo
`
`

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`Road,
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`Irvine, California 92618.
`
`Upon information and belief, Defendant Anchen
`
`Pharmaceuticals, Inc. manufactures and/or distributes numerous generic drugs for sale and use
`
`throughout the United States, including in this judicial district, and including as a subsidiary and
`
`agent of Par Pharmaceutical, Inc.
`
`8.
`
`Upon information and belief, Defendant Amerigen Pharmaceuticals, Inc.
`
`is a
`
`Delaware corporation having a principal place of business at 9 Polito Avenue, Suite 900,
`
`Lyndhurst, New Jersey, 07071.
`
`Upon information and belief, Defendant Amerigen
`
`Pharmaceuticals, Inc. manufactures and/or distributes numerous generic drugs for sale and use
`
`throughout the United States, including in this judicial district, and including as an agent for
`
`Amerigen Phannaceuticals Ltd.
`
`9.
`
`Upon information and belief, Defendant Amerigen Pharmaceuticals Ltd.
`
`is a
`
`Cayman Islands corporation having a registered office at C/0 Coclan Trust Company (Cayman)
`
`Limited, Cricket Square, Hutchins Drive, P.O. Box 2681, Grand Cayman, KY1-1111 Cayman.
`
`Upon information and belief, Defendant Amerigen Pharmaceuticals Ltd. (referred to herein,
`
`together with Amerigen Pharmaceuticals, Inc. as "Amerigen") manufactures and/or distributes
`
`numerous generic drugs for sale and use throughout the United States, including in this judicial
`
`district, and including through its agent Amerigen Pharmaceuticals, Inc.
`
`NATURE OF THE ACTION
`
`10.
`
`This is a civil action for the infringement of one or more of the following patents
`
`by each of the Defendants: United States Patent Nos. 8,039,009 ("the ‘O09 patent“), 8,168,209,
`
`as corrected ("the ’209 patent"); 8,173,708 ("the '708 patent"); 8,283,379 as corrected ("the '379
`
`patent"); 8,329,752 ("the '752 patent"); 8,362,085 ("the ‘O85 patent"); and 8,598,233 ("the '233
`
`patent"). This action is based upon the Patent Laws of the United States, 3.5 U.S.C.. § 1 et seq.
`
`

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`JURISDICTION AND VENUE
`
`11.
`
`This Court has jurisdiction over the subject matter of this action pursuant to 28
`
`U.S.C. §§ 1331 ‘and 1338(a).
`
`12.
`
`This Court has personal jurisdiction over each of the Defendants by virtue of the
`
`fact that, inter alia, each Defendant has committed, or aided, abetted, induced, contributed to,
`
`and/or participated in the commission of, a tortious act of patent infringement that has led to
`
`foreseeable harm and injury to Plaintiffs in Delaware. This Court has personal jurisdiction over
`
`each of the Defendants for the additional reasons set forth below and for other reasons that will
`
`be presented to the Court if such personal jurisdiction is challenged.
`
`13.
`
`This Court has personal jurisdiction over Defendant Lupin Limited by virtue of,
`
`inter alia:
`
`(1) its presence in Delaware, including through its subsidiary and agent Defendant
`
`Lupin Pharmaceuticals, Inc.; and (2) its systematic -and continuous contacts with Delaware,
`
`including through its subsidiary and agent Lupin Pharmaceuticals, Inc. On information and
`
`belief, Lupin Limited is amenable to litigating in this forum based on Lupin Lirnited's conduct in
`
`multiple prior litigations in this District. In particular, Lupin Limited did not contest jurisdiction
`
`in Civil Action No. 14-184 (D.I. 28) or Civil Action No. 13-1604 (D.I. 11).
`
`14.
`
`This Court has personal jurisdiction over Defendant Lupin Pharmaceuticals, Inc.
`
`by virtue‘ of, inter alia: (1) its presence in Delaware, including through its parent Defendant
`
`Lupin Limited; and (2) its systematic and continuous contacts with Delaware, including through
`
`its parent Lupin Limited. On information and belief, Lupin Pharmaceuticals, Inc. is amenable to
`
`litigating in this forum based on Lupin Pharmaceuticals, Inc.'s conduct
`
`in multiple prior
`
`litigations in this District.
`
`In particular, Lupin Pharmaceuticals, Inc. did not contest jurisdiction
`
`in Civil Action No. 14-184 (D.I. 28) or Civil Action No. 13-1604 (D.I. 11).
`
`

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`15.
`
`This Court has personal jurisdiction over Defendant Par Pharmaceutical, Inc. by
`
`virtue of, inter alia, the fact that Par Pharmaceutical, Inc. is a Delaware corporation.
`
`16.
`
`This Court has personal jurisdiction over Defendant Anchen Pharmaceuticals, Inc.
`
`by virtue of, inter alia:
`
`(1) its presence in Delaware, including through its parent Defendant Par
`
`Pharmaceutical, Inc.; and (2) its systematic and continuous contacts with Delaware, including
`
`through its parent Par Pharmaceutical, Inc. On information and belief, Anchen Pharmaceuticals,
`
`Inc. is amenable to litigating -in this forum based on Anchen Pharmaceuticals, Inc.'s conduct in
`
`multiple prior litigations in this District.
`
`In particular, Anchen Pharmaceuticals, Inc. did not
`
`contest jurisdiction in this District in Civil Action No. 14-200 (D.I. 26) (related case), Civil
`
`Action No. 13-202 (111. 15) or Civil Action No. 12-808 (D.I. 13).
`
`17.
`
`This Court has personal jurisdiction over Defendant Arnerigen Pharmaceuticals,
`
`Inc. by virtue of,
`
`inter alia,
`
`the fact that Amerigen Pharmaceuticals,
`
`Inc.
`
`is a Delaware
`
`corporation.
`
`18.
`
`This Court has personal jurisdiction over Defendant Amerigen Pharmaceuticals
`
`Ltd. by virtue of, inter alia:
`
`(1) its presence in Delaware, including through its agent Defendant
`
`Amerigen Pharmaceuticals, Inc.; and (2) its systematic and continuous contacts with Delaware,
`
`including through its agent Defendant Amerigen Pharmaceuticals, Inc. On information and
`
`belief,_ Amerigen Pharmaceuticals Ltd. is a1nenab1e_ to litigating in this forum based on Amerigen
`
`Pharmaceuticals Ltd.'s conduct
`
`in multiple prior litigations in this District.
`
`In particular,
`
`Amerigen Pharmaceuticals Ltd. did not contest jurisdiction in Civil Action No. 14-508 (D.I. 36)
`
`(related case), Civil Action No. 13-1156 (D.l. 9) or Civil Action No. 12-305 (D.I. 37).
`
`19.
`
`Venue is proper in this judicial district as to all Defendants pursuant to 28 U.S.C.
`
`§§ 1391 and 1400(1)).
`
`

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`THE PATENTS
`
`20.
`
`On October 18, 2011, the ‘O09 patent, titled "Modified Release Formulations Of
`
`Memantine Oral Dosage Forms," was duly and legally issued by the USPTO. Since the issuance
`
`of the '009 patent, Forest Laboratories Holdings, Ltd. has been, and continues to be, the ‘O09
`
`parent's sole owner. A copy of the ‘O09 patent is attached hereto as Exhibit A.
`
`21.
`
`On May 1, 2012,
`
`the '209 patent,
`
`titled "Method And Composition For
`
`Administering An NMDA Receptor Antagonist To A Subject," was duly and legally issued by
`
`the USPTO. The USPTO issued a certificate of correction for the '209 patent on June 26, 2012.
`
`Since the issuance of the '209 patent, Adamas has been, and continues to be, the '209 patent's
`
`sole owner. Forest is the exclusive licensee of the '209 patent with respect to commercializing
`
`pharmaceutical products containing memantine in the United States. A copy of the '209 patent,
`
`including its certificate of-correction, is attached hereto as Exhibit B.
`
`22.
`
`On May 8, 2012,
`
`the '708 patent,
`
`titled "Method And Composition For
`
`Administering An NMDA Receptor Antagonist To A Subject," was duly and legally issued by
`
`the USPTO. Since the issuance of the "708 patent, Adamas has been, and continues to be, the
`
`'708 patent's' sole owner. Forest is the exclusive licensee of the '708 patent with respect to
`
`commercializing pharmaceutical products containing memantine in the United States. A copy of
`
`the '708 patent is attached hereto as Exhibit C.
`
`23.
`
`On October 9, 2012, the '379 patent, titled "Method And Compositions For The
`
`Treatment Of CNS-Related Conditions," was duly and legally issued by the USPTO. The
`
`USPTO issued a certificate of correction for the '379 patent on July 8, 2014. Since the issuance
`
`of the '379 patent, Adamas has been, and continues to be, the '379 patent's sole owner. Forest is
`
`the exclusive licensee of the '379 patent with respect
`
`to commercializing pharmaceutical
`
`

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`products containing memantine in the United States.. A copy of the ‘379 patent, including its
`
`certificate of correction, is attached hereto as Exhibit D.
`
`24.
`
`On December 11, 2012, the '752 patent, titled "Composition For Administering
`
`An NMDA Rec.eptor Antagonist To A Subject," was duly and legally issued by the USPTO.
`
`Since the issuance of the '752 patent, Adamas has been, and continues to be, the '752 patent‘s
`
`sole owner. Forest is the exclusive licensee of the '752 patent with respect to commercializing
`
`pharmaceutical products containing memantine in the United States. A copy of the "I52 patent is
`
`attached hereto as Exhibit E.
`
`25.
`
`On January 29, 2013, the ‘O85 patent, titled "Method For Administering An
`
`NMDA Receptor Antagonist To A Subject," was duly and legally issued by the USPTO. Since
`
`the issuance of the ‘O85 patent, Adamas has been, and continues to be, the '085 patent's sole
`
`owner. Forest is the exclusive licensee of the ‘O85 patent with respect to commercializing
`
`pharmaceutical products containing memantine in the United States. A copy of the ‘O85 patent is
`
`attached hereto as Exhibit F.
`
`26.
`
`On December 3, 2013', the '233 patent, titled "Method For Administering An
`
`NMDA Receptor Antagonist To A Subject," was duly and legally issued by the USPTO. Since
`
`the issuance of the '233 patent, Adamas has been, and continues to be, the '233 patent's sole
`
`owner. Forest is the exclusive licensee of the ‘233 patent with respect to commercializing
`
`pharmaceutical products containing memantine in the United States. A copy of the '233 patent is
`
`attached hereto as Exhibit G.
`
`27.
`
`Forest Laboratories,
`
`Inc. (n/k/a Forest Laboratories, LLC) holds New Drug
`
`Application ("NDA") 22-525 for Namenda XR® brand memantine hydrochloride extended
`
`release capsules. The ‘O09 patent,_the ‘.209 patent, the '708 patent, the '379 patent, the '752 patent,
`
`

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`the ‘O85 patent, and the ‘233 patent are all listed in Approved Drug Products with Therapeutic
`
`Equivalence Evaluations ("the Orange Book“) for Namenda XR®.
`
`28.
`
`Forest is the exclusive distributor ofNamenda XR® in the United States.
`
`ACTS GIVING RISE TO THIS ACTION
`
`Count I - Patent Infringement by Lupin
`
`29.
`
`Upon information and belief, on or before July 22, 2014, Lupin submitted ANDA
`
`No. 206028 to the United States Food and Drug Administration ("FDA“) under § 505 of the
`
`Federal Food, Drug and Cosmetic Act (21 U.S.C. § 3550)). ANDA No. 206028 seeks FDA
`
`approval for the commercial manufacture, use, and sale of generic extended release capsule
`
`products containing 7, 14, 21, and 28 milligrams of memantine hydrochloride as the active
`
`ingredient ("the Lupin Generic Products"). ANDA No. 206028 specifically seeks FDA approval
`
`to market the Lupin Generic Products prior to the expiration of the ‘O09 patent, the '209 patent,
`
`the '708 patent, the '3_79 patent, the ‘752 patent, the ‘O85 patent, and the '233 patent.
`
`30.
`
`Pursuant to '§ 505(j)(2)(A)(vii)(IV) o.f the Federal Food, Drug and Cosmetic Act,
`
`ANDA No. 206028 alleges that the claims of the ‘O09 patent, the '209 patent, the '708 patent, the
`
`'3 79 patent, the '752 patent, the ‘O85 patent, and the ‘233 patent are invalid, unenforceable, and/or
`
`will not be infringed by the manufacture, use, or sale. of the Lupin Generic Products. Plaintiffs
`
`received written notification of ANDA No. 206028 and its § 505(j).(2)(A)(vii)(IV) allegations on
`
`or about July 24, 2014.
`
`31.
`
`Lupin's
`
`submission of ANDA No. 206028 to the FDA,
`
`including its
`
`§ 505(j)(2)(A)(vii)(lV) allegations, constitutes infringement of the '209 patent, the '708 patent,
`
`the '379 patent,
`
`the '752 patent,
`
`the ‘O85 patent, and the ‘233 patent under 35 U.S.C.
`
`§271(e)(2)(A). Moreover, if Lupin commercially manufactures, uses, offers for sale, or sells
`
`

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`within the United States, or imports into the United States, the Lupin Generic Products, or
`
`induces or contributes to any such conduct, it would further infringe the '209 patent, the "708
`
`patent, the '379 patent, the '752 patent, the ‘O85 patent, andfor the ‘233 patent under 35 U.S.C.
`
`§271(a), (b), and/or (c). For purposes of clarity, Plaintiffs state that they are not asserting
`
`‘Claims 6-15 of the '379 patent against the Lupin Generic Products or any other generic extended
`
`release memantine hydrochloride product that contains rnemantine hydrochloride as the sole
`
`active ingredient. Relying on the representations set out in Lupin's notice of Paragraph IV
`
`Certification pursuant to 21 U.S.C. § 355(j)(2)(B')(ii) and 21 C.F.R. § 314.95, Plaintiffs do not
`
`allege at this time that the Lupin Generic Products infringe the ‘O09 patent. To the extent that
`
`discovery in this action demonstrates that assertion of the ‘O09 patent against the Lupin Generic
`
`Products is warranted, Plaintiffs reserve the right to assert it.
`
`32.
`
`Upon information and belief, each of Lupin Limited and Lupin Phannaceuticals,
`
`Inc. has participated in, contributed to, aided, abetted, and/or induced infringement of the '209
`
`patent, the '708 patent, the '379 patent, the "/'52 patent, the ‘O85 patent, and/or the ‘Z33 patent
`
`and/or will participate in, contribute to, aid, abet, and/or induce infringement of the ‘Z09 patent,
`
`the "108 patent, the '379 patent, the "152 patent, the ‘O85 patent, and/or the '233 patent once the
`
`Lupin Generic Products are manufactured, used, offered for sale, or sold in the United States, or
`
`imported into the United States. Each of Lupin Limited and Lupin Pharmaceuticals, Inc. is
`
`jointly and severally liable for the infringement of the '209 patent, the '708 patent, the '379
`
`patent, the '752 patent, the ‘O85 patent, and/or the '233 patent.
`
`33.
`
`Lupin was aware of the '209 patent, the ’708 patent, the '379 patent, the ‘752
`
`patent,
`
`and
`
`the
`
`'085
`
`patent
`
`prior
`
`to
`
`filing ANDA No.
`
`206028,
`
`including
`
`its
`
`

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`§ 505(j)(2)(A)(vii)(IV) allegations with respect to those patents, and was aware of the ‘Z33 patent
`
`at least prior to making its § 505(i)(2)(A)(vii)(IV) allegation with respect to that patent.
`
`34.
`
`3-5.
`
`Lupin's actions render this an exceptional case under 35 U..S.C. § 285.
`
`Plaintiffs will be irreparably harmed by Lupin's infringing activities unless those
`
`activities are enjoined by this Court. Plaintiffs do not have an adequate remedy at law.
`
`Count II - Patent Infringement by Anchen and Par
`
`36.
`
`Upon information and belief, on or before January 6, 2014, Anchen and Par
`
`submitted ANDA No. 205784 to the FDA under § 505 of the Federal Food, Drug and Cosmetic
`
`Act (21 U.S.C. § 3550)). ANDA No. 205784 seeks FDA approval for the commercial
`
`manufacture, use, and sale of generic extended release capsule products containing 28 milligrams
`
`of memantine hydrochloride as the active ingredient ("the Anchen Generic Product").
`
`37.
`
`Pursuant to §505(i)(2)(A)(vii)(IV) of the Federal Food, Drug and Cosmetic
`
`Act, ANDA No. 205784 previously included allegations that the claims of the ‘O09 patent, the
`
`'209 patent, the '708 patent, the '379 patent, the "752 patent, and the ‘O85 patent are invalid,
`
`unenforceable, and/or will not be infringed by the manufacture, use, or sale of the Anchen
`
`Generic Product. Plaintiffs received written notification of ANDA No. 205784 and its previous
`
`§ 505 (j)(2)(A)(vii)(IV) allegations with respect to the '009 patent, the ‘209 patent, the ‘708 patent,
`
`the '379 patent, the '752 patent, and the ‘O85 patent on or about January 7, 2014. The written
`
`notification also stated that ANDA No. 205784 contained a §505(j)(2)(A)(vii)(IV) allegation
`
`that the claims of the '233 patent are invalid, unenforceable and/or will not be infiinged by the
`
`manufacture, use, or sale of the Anchen Generic Product. Plaintiffs timely brought suit against
`
`Anchen and Par for infringement of the '209 patent, the "708 patent, the '379 patent, the '752
`
`10
`
`

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`patent, the '085 patent, and the '233 patent on or about February 14, 2014 in Forest Laboratories,
`
`Inc., et al. v. Apotex Corp., er 511., Civil Action No. 14-200-LPS.
`
`38.
`
`Upon information and belief, pursuant to § 505(i)(2)(A)(vii)(IV) of the Federal
`
`Food, Drug and Cosmetic Act, ANDA No. 205784 was recently amended to include an
`
`allegation that the claims of the '233 p_atent are invalid, unenforceable, andfor will not be
`
`infringed by the manufacture, use, or sale of the Anchen Generic Product. Upon information and
`
`belief, prior to this amendment, ANDA No. 205784 did not include a § 50S(i)(2)(A)(vii)(IV)
`
`allegation with respect to the '233 patent, contrary to Anchen and Par’s representation in the
`
`written notification "received on or about January 7, 2014. Plaintiffs ‘received written notification
`
`of Anchen and Par's amended § 505(i)(2)(A)(vii)(IV) allegation with respect to the '233 patent
`
`on or about July 7, 2014.
`
`39.
`
`Anchen and Par's submission of ANDA No. 205784 to the FDA, including their
`
`recent § 505(j)_(2)(A)('vii)(IV) allegation with respect to the '233 patent, constitutes infringement
`
`of the '233 patent under 35 U.S.C. §271(e)(2)(A). Moreover, if Anchen and Par commercially
`
`manufacture, use, offer for sale, or sell within the United States, or import into the United States,
`
`the Anchen Generic Product, or induce or contribute to any such conduct, they would further
`
`infringe the '233 patent under 35 U.S.C. §271(a), (b), and/or (c).
`
`40.
`
`Upon information and belief, each of Anchen and Par has participated in,
`
`contributed to, aided, abetted, and/or induced infringement of the '233 patent and/or will
`
`participate in, contribute to, aid, abet, and/or induce infringement of the '233 patent once the
`
`Anchen Generic Product is manufactured, used, offered for sale, or sold in the United States, or
`
`imported into the United States. Each of Anchen and Par is jointly and severally liable for the
`
`infringement of the '233 patent.
`
`11
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`

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`41.
`
`Anchen and Par were aware of the '233 patent at least prior to making their
`
`§ 505(j)(2)(A)(vii)(IV) allegation with respect to that patent.
`
`42.
`
`43.
`
`Anchen and Par's actions render this an exceptional case under 35 U.S.C. § 285.
`
`Plaintiffs will. be irreparably harmed by Anchen and Par's infringing activities
`
`unless those activities are enjoined by this Court. Plaintiffs do not have an adequate remedy at
`
`law.
`
`Count III — Patent Infringement by Par
`
`44.
`
`Upon infonnation and belief, on or before January 29, 2014, Par submitted
`
`ANDA No. 205783 to the FDA under § 505 of the Federal Food, Drug and Cosmetic Act (21
`
`U.S.C. § 3550)). ANDA No. 205783 seeks FDA approval for the commercial manufacture, use,
`
`and sale of generic extended release capsule products containing 28 milligrams of memantine
`
`hydrochloride as the active ingredient ("the Par Generic Product").
`
`45.
`
`Pursuant to §505(j)(2)(A)(vii)(IV) of the Federal Food, Drug and Cosmetic
`
`Act, ANDA No. 205783 previously included allegations that the claims of the '009 patent, the
`
`'209 patent, the '708 patent, the '379 patent, the '752 patent, and the '085 patent are invalid,
`
`unenforceable, and/or will not be infringed by the manufacture, use, or sale of the Par Generic
`
`Product.
`
`Plaintiffs received written notification of ANDA No. 205783 and its previous
`
`§ 505_(j)(2)(A)(vii)(IV) allegations with respect to the ‘O09 patent, the '209 patent, the '708 patent,
`
`the '379 patent, the '752 patent, and the '085 patent on or about January 30, 2014. The written
`
`notification also stated that ANDA No. 205783 contained 21 § 505(j)(2)(A)(vii)(IV) allegation
`
`that the claims of the '233 patent are invalid,. unenforceable and/or will not be infringed by the
`
`manufacture, use, or sale of the Par Generic Product. Plaintiffs timely brought suit against Par
`
`for infringement of the '009 patent, the '209 patent, the '708 patent, the '379 patent, the ‘752
`
`12
`
`

`
`Case 1:14-cv-01058-LPS Document 1 Filed 08/15/14 Page 13 of 20 PageID #: 13
`Case 1:14—cv—O1058—LPS Document 1 Filed 08/15/14 Page 13 of 20 Page|D #: 13
`
`patent, the '085 patent, and the ’233 patent on or about February 14, 2014 in Forest Laboratories,
`
`Inc., et al. v. Apotex C0rp., er 011., Civil Action No. 14-200-LPS.
`
`46.
`
`Upon information and belief, pursuant to § 505(j)(,2)(A)(vii)(IV) of the Federal
`
`Food, Drug and Cosmetic Act, ANDA No. 205783 was. recently amended to include an
`
`allegation that the -claims of the '233 patent are invalid, unenforceable, and/or will not be
`
`infiinged by the manufacture, use, or sale of the Par Generic Product. Upon information and
`
`belief, prior to this amendment, ANDA No. 205783 did not include a § 505(j)(2)(A)(vii)(IV)
`
`allegation with respect
`
`to the '233 patent, contrary to Pat's representation in the written
`
`notification received on or about January 30_, 2014. Plaintiffs received written notification of
`
`Par‘s amended § 505(j)(2)(A)(vii)(IV) allegation with respect to the '233 patent on or about July
`
`7, 2014.
`
`47.
`
`Par‘s submission of ANDA No. 205783 to the FDA,
`
`including its recent
`
`§ 505(i)(2)(A)(vii)(IV) allegation with respect to the ‘233 patent, constitutes infringement of the
`
`'233 patent under 35 U.S.C. § 271(e)(2)(A). Moreover, "if Par commercially manufactures, uses,
`
`offers for sale, or ‘sells within the United States, or imports into the United States, the Par
`
`Generic Product, or induces or contributes to any such conduct, it would further infringe the '233
`
`patent under 35 U.S.C. § 271(a), (b), and/or (c).
`
`48.
`
`Par was
`
`aware of
`
`the
`
`'233
`
`patent
`
`at
`
`least prior
`
`to making
`
`its
`
`§ 505(j)(2)(A)(vii)(IV) allegation with respect to that patent.
`
`49.
`
`50.
`
`Par‘s actions render this an exceptional case under 35 U.S.C. § 285.
`
`Plaintiffs will be irreparably harmed by Par‘s infringing activities unless those
`
`activities are enjoined by this Court. Plaintiffs do not have an adequate remedy at law.
`
`13
`
`

`
`Case 1:14-cv-01058-LPS Document 1 Filed 08/15/14 Page 14 of 20 PageID #: 14
`Case 1:14—cv—O1058—LPS Document 1 Filed 08/15/14 Page 14 of 20 Page|D #: 14
`
`Count IV — Patent Infringement by Amerigen
`
`51.
`
`Upon information and belief, on or before March 31, 2014, Amerigen submitted
`
`ANDA No. 205365 to the FDA under § 505 of the Federal Food, Drug and Cosmetic Act (21
`
`U.S.C. § 3550)) seeking FDA approval for the commercial manufacture, use, and sale of generic
`
`extended re-lease capsule products containing 7, 14, and 28 milligrams of memantine
`
`hydrochloride as the active ingredient ("the Amerigen Generic Products"). ANDA No. 205365
`
`specifically seeks FDA approval to market the 7, 14, and 28 milligram dosage forms of the
`
`Amerigen Generic Products prior to the expiration of the ‘O09 patent, the '209 patent, the ‘708
`
`patent, the '379 patent, the '752 patent, the 085 patent, and the '233 patent.
`
`52.
`
`Pursuant to § 505(j)(2)(A)(vii)(IV) of the Federal Food, Drug and Cosmetic
`
`Act, ANDA No. 205365 includes allegations that the claims of the ‘O09 patent, the '209 patent,
`
`the '708 patent, the '379 patent, the '752 patent, the ‘O85 patent, and the '233 patent are invalid,
`
`unenforceable, and/or will not be infi-inged by the manufacture, use, or sale of the 7, 14, and 28
`
`milligram dosage forms of the Amerigen Generic Products. Forest and Adamas received written
`
`notification of ANDA No. 205365 and its § 505(j)(2)(A)(vii)(IV) allegations on or about April 1,
`
`2014. Plaintiffs timely brought suit against Amerigen for infringement of the ‘O09 patent, the
`
`'209 patent, the '708 patent, the ‘379 patent, the "752 patent, the ‘D85 patent, and the '233 patent
`
`on or about April 21, 2014 in Forest Laboratories, Inc, et al. v. Amneal Pharmaceuticals LLC,
`
`et al. , Civil Action No. 14-508-LP-S.
`
`53.
`
`On or about August 6, 2014, Forest and Adamas received written notification
`
`that Amerigen had amended ANDA No. 205365 to include a 21 milligram dosage form of the
`
`Amerigen Generic Products. As amended, ANDA No. 205365 seeks FDA approval for the
`
`commercial manufacture, use, and sale of generic extended release capsule products containing
`
`14
`
`

`
`Case 1:14-cv-01058-LPS Document 1 Filed 08/15/14 Page 15 of 20 PageID #: 15
`Case 1:14—cv—O1058—LPS Document 1 Filed 08/15/14 Page 15 of 20 Page|D #: 15
`
`21 milligrams of memantine hydrochloride as the active ingredient. ANDA No. 205365
`
`specifically seeks FDA approval to market the 21 milligram dosage form of the Amerigen
`
`Generic Products prior to the expiration of the ‘O09 patent, the '209 patent, the '708 patent, the
`
`'3 79 patent, the '752 patent, and the ‘O85 patent.
`
`S4.
`
`Pursuant ‘to § 505(i)(2)(A)(vii)(IV) of the Federal Food, Drug and Cosmetic
`
`Act, ANDA No. 205365 alleges that the claims of the ‘O09 patent, the '209 patent, the '708
`
`patent, the '3 79 patent, the '752 patent, and the ‘O85 patent are invalid, unenforceable, and/or will
`
`not be infringed by the manufacture, use, or sale of the 21 rnilligrarn dosage form of the
`
`Amerigen Generic Products.
`
`55.
`
`Ame-rigen's submission of its amendment to ANDA No. 205365 to the FDA,
`
`including its § 505(j)(2)(A)(vii)(IV) allegations regarding the 21 milligram dosage form of the
`
`Amerigen Generic Products, constitutes infringement of the ‘O09 patent, the '209 patent, the '708
`
`patent, the '379 patent, the '752 patent, and the ‘O35 patent under 35 U.S.C. § 271(e)(2)(A).
`
`Moreover, if Amerigen commercially manufactures, uses, offers for sale, or sells within the
`
`United States, or imports into the United States, the 21 milligram dosage form of the Amerigen
`
`Generic Products, or induces or contributes to any such conduct, it would further infiinge the
`
`‘O09 patent, the ‘209 patent, the '708 patent, the '3.79 patent, the '752 patent, and the ‘O85 patent
`
`under 35 U.S.C. §_ 271(a), (b), and/or (0). For purposes of clarity, Forest and Adamas state that
`
`they are not asserting Claims 6-15 of the '379 patent against the 21 milligram dosage form of the
`
`Amerigen Generic Products or any other generic extended release memantine hydrochloride
`
`product that contains memantine hydrochloride as the sole active ingredient.
`
`56.
`
`Upon information and belief, each of Amerigen Pharmaceuticals, Inc. and
`
`Amerigen Pharmaceuticals Ltd. has participated in, contributed to, aided, abetted, and/or induced
`
`15
`
`

`
`Case 1:14-cv-01058-LPS Document 1 Filed 08/15/14 Page 16 of 20 PageID #: 16
`Case 1:14—cv—O1058—LPS Document 1 Filed 08/15/14 Page 16 of 20 Page|D #: 16
`
`infringement of the ‘O09 patent, the '209 patent, the '708 patent, the '379 patent, the '752 patent,
`
`and the ‘D85 patent and/or will participate in, contribute to, aid, abet, and/or induce infringement
`
`of the ‘O09 patent, the '209 patent, ‘the '708 patent, the '379 patent, the '752 patent, and the '085
`
`patent once the 21 milligram dosage form of the Amerigen Generic Products is manufactured,
`
`used, offered for sale, or sold in the United States, or imported into the United States. Each of
`
`Amerigen Pharmaceuticals, Inc. and Amerigen Pharmaceuticals Ltd.
`
`is jointly and severally
`
`liable for the infringement of the '009 patent, the '209 patent, the '708 patent, the '379 patent, the
`
`'752 patent, and the '085 patent.
`
`S7.
`
`Amerigen was aware of the ‘"009 patent, the ‘209 patent, the '708 patent, the '379
`
`patent, the '752 patent, and the ‘O85 patent at least prior to filing its amendment to ANDA No.
`
`205365, including its § 50S(j_)(2)(A)(vii)(IV) allegations with respect to those patents.
`
`58.
`
`59.
`
`Amerigetfs actions render this an exceptional case under 35 U.S.C. § 285.
`
`Forest and Adamas will be irreparably harmed by Amerigen's infringing activity
`
`unless those activiti.es are enjoined by- this Court. Forest and Adamas do not have an adequate
`
`remedy at law.
`
`PRAYER FOR RELIEF
`
`WHEREFORE, Plaintiffs pray for judgment as follows:
`
`A.
`
`That Defendant Lupin has infringed the '209 patent, the '708 patent, the '379
`
`patent, the '752 patent, the '085 patent, and the '233 patent;.
`
`B.
`
`C.
`
`D.
`
`That Defendants A