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`IN THE UNITED STATES DISTRICT COURT
`
`FOR THE DISTRICT OF DELAWARE
`
`) ) ) ) ) ) ) )
`
`FOREST LABORATORIES, INC., FOREST
`LABORATORIES HOLDINGS, LTD., and
`
`ADAMAS PHARMACEUTICALS, lNC.,
`
`Plaintiffs,
`
`v.
`
`AP()TEXCORP..APOTEXINC.,ZYDUS
`
`) C.A.No.
`
`) ) ) ) )
`
`_)
`
`) )
`
`PHARMACEUTICALS (USA). INC..
`CADILA IIEAL'l"l—ICARl3 LTD. (d/b/af
`
`ZYDUS CADII./\). PAR
`PHARMACEUTICAI., INC, ANCIIEN
`
`PHARMACEUTICALS, INC. and WATSON
`LABORATORIES, INC. — FLORIDA,
`
`Defendants.
`
`COMPLAINT
`
`Plaintiffs Forest Laboratories, Inc., Forest Laboratories Holdings, Ltd., and Adamas
`
`Pharmaceuticals, Inc. (collectively, "Plaintiffs"), for their Complaint against Defendants Apotex
`
`Corp., Apotex lnc.. Zydus Pharmaceuticals (USA), Ine., Cadila I-Iealtheare Ltd. (d/b/af Zydus
`
`Cadila), Par Pharmaceutical, Inc.. Anehen Phannaceutieals. Inc., and Watson Laboratories, Inc. -
`
`Florida (collectively, "Defendants"), hereby allege as follows:
`
`PARTIES
`
`1.
`
`Plaintiff Forest Laboratories, Inc. is a Delaware corporation having a principal
`
`place of business at 909 Third Avenue, New York, New York 10022.
`
`2.
`
`Plaintiff Forest Laboratories Holdings, Ltd. is an Irish corporation having a
`
`principal place of business at Columbia House, 1 Victoria Street, Hamilton HM1 1, Bermuda
`
`(referred to herein, together with Forest Laboratories, Ine., as "Forest").
`
`

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`3.
`
`Plaintiff Adamas Pharmaceuticals, Inc. ("Adamas") is a Delaware corporation
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`having a principal place of business at 2200 Powell Street, Suite 220, Emeryville, California
`
`94608.
`
`4.
`
`Upon information and belief, Defendant Apotex Corp. is a Delaware corporation
`
`having a principal place of business at 2400 North Commerce Parkway, Suite 400, Weston.
`
`Florida 33326. Upon information and belief, Defendant Apotex Corp. 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 of Apotex Inc.
`
`5.
`
`Upon information and belief. Defendant Apotex Inc. is a Canadian corporation
`
`having a principal place of business at 150 Signet Drive. Toronto. Ontario. Canada l\/l9L l'l‘9.
`
`Upon information and belief, Defendant Apotex lnc. (referred to herein. together with Apotex
`
`Corp, as "Apotex") 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
`
`Apotex Corp.
`
`6.
`
`Upon information and belief, Defendant Zydus Pharmaceuticals (USA), Inc. is a
`
`New Jersey corporation having a principal place of business at 73 Route 31 N., Pennington, New
`
`Jersey 08534. Upon information and belief, Defendant Zydus Pharmaceuticals (USA), inc. is a
`
`subsidiary ofCadila Healthcare Ltd. (d/b/a/ Zydus Cadila). Upon information and belief,
`
`Defendant Zydus Pharmaceuticals (USA), Inc. manufactures and/or distributes numerous generic
`
`drugs for sale and use throughout the United States. including in thisjudicial district, and
`
`including as a subsidiary and agent of Cadila I-lealthcare Ltd. (d/b/af Zydus Cadila).
`
`7'.
`
`Upon information and belief, Defendant Cadila Healthcare Ltd. (d/b/aJ’ Zydus
`
`Cadila) is an Indian corporation having a principal place of business at Zydus Tower, Satellite
`
`

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`Cross Roads, Ahmedabad-3 80015, Gujurat, India. Upon information and belief, Defendant
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`Cadila Healthcare Ltd. (d/b/a/ Zydus Cadila) (referred to herein, together with Zydus
`
`Pharmaceuticals (USA), Inc., as "Zydus") manufactures and/or distributes numerous generic
`
`drugs for sale and use throughout the United States. including in thisjudicial district. and
`
`including through its subsidiary and agent Zydus Pharmaceuticals (USA), Inc.
`
`8.
`
`Upon information and belief, Defendant Par Pharmaceutical, Inc. ("Par") is a
`
`Delaware corporation having a principal place of business at 300 Tice Boulevard, Woodcliff
`
`Lake, New Jersey 07677. 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.
`
`9.
`
`Upon information and belief, Defendant Anchen Pharmaceuticals, Inc.
`
`("Anchen") is a California corporation having a principal place of business at 9601 Jeronimo
`
`Road, 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.
`
`10.
`
`Upon information and belief, Defendant Watson Laboratories, Inc. - Florida
`
`("Watson") is a Florida corporation with a principal place ofbusiness at 4955 Orange Drive,
`
`Davie, Florida 33314. Upon information and belief, Defendant Watson Laboratories, Inc. -
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`Florida manufactures and/or distributes numerous generic drugs for sale and use throughout the
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`United States, including in thisjudicial district.
`
`

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`NATURE OF THE ACTION
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`11.
`
`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 '009 patent"); 8,168,209,
`
`as corrected ("the '209 patent"); 8,173,708 ("the '708 patent"); 8,283,379 ("the '379 patent");
`
`8,329,752 ("the '752 patent"): 8,362,085 ("the '085 patent"); and 8,598,233 ("the '233 patent").
`
`This action is based upon the Patent Laws ofthe United States, 35 U.S.C. § 1 er seq.
`
`JURISDICTION AND VENUE
`
`12.
`
`This Court has jurisdiction over the subject matter of this action pursuant to 28
`
`U.S.C. §§ 1331 and 1338(a).
`
`13.
`
`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.
`
`14.
`
`This Court has personal jurisdiction over Defendant Apotcx Corp. by virtue of.
`
`inter aim. the fact that Apotex Corp. is a Delaware corporation.
`
`15.
`
`This Court has personal jurisdiction over Defendant Apotcx Inc. by virtue of,
`
`inter aliaz (1) its presence in Delaware, including through its agent Defendant Apotex Corp;
`
`and (2) its systematic and continuous contacts with Delaware, including through its agent Apotex
`
`Corp. On information and belief, Apotex Inc. is amenable to litigating in this forum based on
`
`Apotex Inc.'s conduct in multiple prior litigations in this District.
`
`In particular, Apotex lne. did
`
`

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`not contestjurisdiction in Civil Action No. 13-1613 (D.I. 8) or Civil Action No. l3-1602 ([).l.
`
`17).
`
`16.
`
`This Court has personal jurisdiction over Defendant Zydus Pharmaceuticals
`
`(USA), Inc. by virtue of, inter alia:
`
`(1) its presence in Delaware, including through its parent
`
`Defendant Cadila Healthcare Ltd. (d/b/a/ Zydus Cadila); and (2) its systematic and continuous
`
`contacts with Delaware, including through its parent Cadila Healthcare Ltd. (d/b/a/ Zydus
`
`Cadila). On information and belief, Zydus Pharmaceuticals (USA), Inc. is amenable to litigating
`
`in this forum based on Zydus Pharmaceuticals (USA), lne.'s conduct in at least one prior
`
`litigation in this District, Civil Action No. l0-58] (D.l. 9).
`
`17.
`
`This Court has personal jurisdiction over Defendant Cadila Healthcare Ltd. (d/b/a!
`
`Zydus Cadila) by virtue of. inter alia:
`
`(1) its presence in Delaware, including through its
`
`subsidiary and agent Defendant Zydus Pharmaceuticals (USA), lnc.; and (2) its systematic and
`
`continuous contacts with Delaware, including through its subsidiary and agent Zydus
`
`Pharmaceuticals (USA), Inc. On information and belief, Cadila Healtheare Ltd. (d/b/a/ Zydus
`
`Cadila) is amenable to litigating in this forum based on Cadila Healthcare Ltd.'s (d/b/ax’ Zydus
`
`Cadila) conduct in multiple prior litigations in this District.
`
`In particular, Cadila Healthcare Ltd.
`
`(d/b/a/ Zydus Cadila) did not contest jurisdiction in Civil Action No. 13-1143 (DJ. 26) or Civil
`
`Action No. 10-58] (D.l. 13).
`
`18.
`
`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.
`
`19.
`
`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
`
`

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`through its parent Par Pharmaceutical, Inc. On information and belief, Anehen Pharmaceuticals,
`
`Inc. is amenable to litigating in this forum based on Anehen Pharmaceuticals, lnc.‘s conduct in
`
`multiple prior litigations in this District.
`
`In particular, Anchen Pharmaceuticals, Inc. did not
`
`contestjurisdiction in Civil Action No. 13-202 (D.l. 15) or Civil Action No. 12-808 (D.l. 13).
`
`20.
`
`This Court has personal jurisdiction over Defendant Watson Laboratories. lnc. —
`
`Florida by virtue of, inter alia, its systematic and continuous contacts with Delaware. On
`
`inforination and belief, Watson Laboratories, lnc. - Florida is amenable to litigating in this forum
`
`based on Watson Laboratories, Inc. - Florida's conduct in multiple prior litigations in this
`
`District.
`
`In particular, Watson Laboratories, Inc. — Florida did not contest jurisdiction in Civil
`
`Action No. 12-816 (D.l. 16) or Civil Action No. 12-492 (D.l. 56).
`
`21.
`
`Venue is proper in this judicial district as to all Defendants pursuant to 28 U.S.C.
`
`1391 and 1400(b).
`
`THE PATENTS
`
`22.
`
`On October 18, 201 l, the ‘O09 patent, titled "Modified Release Formulations Ol-
`
`Mcmantine Oral Dosage Forms," was duly and legally issued by the USPTO. Since the issuance
`
`of the ‘U09 patent, Forest Laboratories Holdings, Ltd. has been, and continues to be, the ‘O09
`
`patents sole owner. A copy of the ‘O09 patent is attached hereto as Exhibit A.
`
`23.
`
`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
`
`

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`phannaceutical products containing memaritine in the United States. A copy of the "209 patent,
`
`including its certificate of correction, is attached hereto as Exhibit B.
`
`24.
`
`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
`
`"/'08 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 oi‘
`
`the '708 patent is attached hereto as Exhibit C.
`
`25.
`
`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. Since the
`
`issuance of the '379 patent, Adamas has been, and continues to be, the '37‘) patent's sole owner.
`
`Forest is the exclusive licensee of the '379 patent with respect to commercializing
`
`pharmaceutical products containing memantine in the United States. A copy of the ‘Z379 patent is
`
`attached hereto as Exhibit D.
`
`26.
`
`On December 1 1. 2012. the '752 patent, titled "Composition For Administering
`
`An NMDA Receptor 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 patenl‘s
`
`sole owner. Forest is the exclusive licensee of the '752 patent with respect to commercializing
`
`pharmaceutical products containing mentantine in the United States. A copy of the '752 patent is
`
`attached hereto as Exhibit E.
`
`27.
`
`On January 29, 2013. the ‘O35 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
`
`

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`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 '085 patent is
`
`attached hereto as Exhibit F.
`
`28.
`
`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.
`
`29.
`
`Forest Laboratories. Inc. holds New Drug Application ("NIDA") 22-525 for
`
`Namenda XR°” brand memantine hydrochloride extended release capsules. The '00‘) patent, the
`
`'20‘) patent, the '708 patent, the '379 patent, the '752 patent, the ‘O85 patent, and the '233 patent
`
`are all listed in Approved Drug Products with Therapeutic Equivalence Evaluatiomr ("the Orange
`
`Book") for Namenda XR®.
`
`30.
`
`Forest is the exclusive distributor ofNamenda XRQ‘) in the United States.
`
`ACTS GIVING RISE TO THIS ACTION
`
`Count I — Patent Infringement by Agotex
`
`31.
`
`Upon information and belief, on or before January 6, 2014, Apotex submitted
`
`AND/-\ No. 206135 to the United States Food and Drug Administration ("FDA") under § 505 of
`
`the Federal Food, Drug and Cosmetic Act (21 U.S.C. § 3550)). AND/\ No. 206135 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 Apotex Generic Products"). ANDA No. 206135 specifically seeks FDA
`
`

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`approval to market the Apotex Generic Products prior to the expiration of the ‘O09 patent, the
`
`‘209 patent. the '708 patent, the '3 79 patent, the "752 patent, the '085 patent, and the '233 patent.
`
`32.
`
`Pursuant to § 505ti)(2)(A)(vii)(IV) ofthe Federal Food, Drug and Cosmetic Act.
`
`ANDA No. 206135 alleges that the claims ofthe ‘O09 patent, the ‘209 patent. the '708 patent. the
`
`'379 patent, the '752 patent, the '085 patent, and the '233 patent are invalid, unenforceable, and/or
`
`will not be infringed by the manufacture, use, or sale of the Apotex Generic Products. Plaintiffs
`
`received written notification of ANDA No. 206135 and its § 505(i)(2)(A)(vii)(lV) allegations
`
`with respect to the ‘O09 patent, the ‘209 patent, the '708 patent, the '379 patent, the '752 patent,
`
`and the ‘O85 patent on or about January 8, 2014. Plaintiffs received written notification of
`
`Apotex's § 505(j)(2)(A)(vii)(IV) allegation with respect to the ‘233 patent on or about February
`
`11,2014.
`
`33.
`
`Apotex's submission ol'ANDA No. 206135 to the FDA. including its
`
`§ 505(j)(2)(A)(vii)(IV) allegations, constitutes infringement ofthe ‘O09 patent. the ‘209 patent.
`
`the '708 patent, the '3 79 patent, the '752 patent, the ‘O85 patent, and the ‘233 patent under 35
`
`U.S.C. § 27] (e)(2)(A). Moreover, if Apotex commercially manufactures, uses, offers tbr sale, or
`
`sells within the United States, or imports into the United States, the Apotex Generic Products, or
`
`induces or contributes to any such conduct, it would further infringe the ‘009 patent, the ‘209
`
`patent, the '708 patent, the '379 patent, the '752 patent, the ‘O85 patent, and/or the ‘Z33 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 Apotex Generic Products or any other generic
`
`extended release memantine hydrochloride product that contains memantine hydrochloride as the
`
`sole active ingredient.
`
`

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`34.
`
`Upon information and belief, each of Apotex Corp. and Apotex Inc. has
`
`participated in, contributed to, aided, abetted, and/or induced infringement of the ‘O09 patent. the
`
`'209 patent, the '708 patent, the '379 patent, the '752 patent, the ‘O85 patent, and/or the ‘233 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 '3 79 patent, the '752 patent. the 'O85 patent, and/or the ‘233
`
`patent once the Apotex Generic Products are manufactured, used, offered for sale. or sold in the
`
`United States, or imported into the United States. Each of Apotex Corp. and Apotcx Inc. is
`
`jointly and severally liable for the infringement of the ‘O09 patent, the '209 patent, the '708
`
`patent, the '379 patent, the '752 patent, the ‘O85 patent, and/or the '233 patent.
`
`35.
`
`Apotex was aware of the "009 patent, the '209 patent, the '708 patent, the '379
`
`patent, the ‘752 patent, and the ‘O85 patent prior to filing ANDA No. 206135, including its
`
`§ 505(j)(2)(A)(vii)(lV) allegations with respect to those patents.
`
`36.
`
`37.
`
`Apotex‘s actions render this an exceptional case under 35 U.S.C. § 285.
`
`Plaintiffs will be irreparably harmed by Apotex'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 Zydus
`
`38.
`
`Upon information and belief. on or before January 2, 2014. Zydus submitted
`
`ANDA No. 203293 to the United States Food and Drug Administration ("l"I)A") under § 505 of
`
`the Federal Food, Drug and Cosmetic Act (21 U.S.C. § 355(j)). ANDA No. 203293 seeks FDA
`
`approval for the commercial manufacture, use, and sale of generic extended release capsule
`
`products containing 7, I4, 21, and 28 milligrams of memantine hydrochloride as the active
`
`ingredient ("the Zydus Generic Products"). ANDA No. 203293 specifically seeks FDA approval
`
`10
`
`

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`to market the Zydus Generic Products prior to the expiration of the '009 patent, the '209 patent,
`
`the '708 patent, the ’379 patent, the '752 patent, the '085, and the ‘233 patent.
`
`39.
`
`Pursuant to § S05(j)(2)(A)(vii)(IV) of the Federal Food, Drug and Cosmetic Act,
`
`ANDA No. 203293 alleges 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 infringed by the manufacture, use, or sale ofthe Zydus Generic Products. Plaintiffs
`
`received written notification of ANDA No. 203293 and its § 505(j)(2)(A)(vii)(IV) allegations on
`
`or about January 8, 2014.
`
`40.
`
`Zydus's submission of ANDA No. 203293 to the FDA, including its
`
`$5 505(j)(2)(A)(vii)(lV) allegations, constitutes infringement ofthe '209 patent. the "108 patent.
`
`the '37‘) patent, the '752 patent, the ‘O85 patent. and the '233 patent under 35 U.S.C.
`
`§ 271(e)(2)(A). Moreover, if Zydus commercially manufactures, uses, offers for sale, or sells
`
`within the United States, or imports into the United States, the Zydus Generic Products, or
`
`induces or contributes to any such conduct, it would further infringe the '209 patent, the ‘708
`
`patent, the '37‘) patent, the '7S2 patent, the ‘O85 patent, and/or the ‘233 patent under 35 U.S.C.
`
`§ 271(a), (b), and/or (e). For purposes of clarity, Plaintiffs state that they are not asserting claims
`
`6-15 ofthe '379 patent against the Zydus Generic Products or any other generic extended release
`
`memantine hydrochloride product that contains memantine hydrochloride as the sole active
`
`ingredient. Relying on the representations set out in Zydus's notice of Paragraph IV Certification
`
`pursuant to 21 U.S.C. §3S5(i)(2)(B){ii) and 21 C.F.R. § 314.95, Forest does not allege at this
`
`time that the Zydus Generic Products infringe the '009 patent. To the extent that discovery in
`
`this action demonstrates that assertion of the ‘009 patent against the Zydus Generic Products is
`
`warranted, Plaintiffs reserve the right to assert it.
`
`11
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`41.
`
`Upon information and belief, each of Zydus Pharmaceuticals (USA), Inc. and
`
`Cadila Healthcare Ltd. (d/b/a/ Zydus Cadila) has participated in, contributed to. aided, abetted.
`
`and/or induced infringement of the '209 patent. the ‘T08 patent, the "379 patent. the '752 patent,
`
`the ‘O85 patent, and/or the '233 patent and/or will participate in, contribute to, aid, abet. and/or
`
`induce infringement of the '209 patent. the "/O8 patent, the '3 79 patent, the '752 patent. the ‘O85
`
`patent, and/or the "233 patent once the Zydus Generic Products are manufactured, used, offered
`
`for sale, or sold in the United States, or imported into the United States. Each of Zydus
`
`Pharmaceuticals (USA), Inc. and Cadila Healthcare Ltd. (d/b/a/ Zydus Cadila) isjointly and
`
`severally liable for the infringement of the '209 patent, the ‘708 patent, the ‘379 patent, the "/'52
`
`patent, the ‘D85 patent, and/or the '233 patent.
`
`42.
`
`Zydus was aware of the '20‘) patent, the ‘708 patent, the '3 79 patent, the ‘752
`
`patent. and the '085 patent prior to filing ANDA No. 203293. including its
`
`§ 505(j)(2)(A)(vii)(IV) allegations with respect to those patents.
`
`43.
`
`44.
`
`7.ydus‘s actions render this an exceptional case under 35 U.S.C. § 285.
`
`Plaintiffs will be irreparably harmed by Zydus'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 Anchen and Par
`
`45.
`
`Upon information and belief, on or before January 6, 2014, Anchen and Pat
`
`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 a generic extended release capsule product containing 28
`
`milligrams of memantine hydrochloride as the active ingredient ("the Anchen Generic Product").
`
`AND/\ No. 205784 specifically seeks FDA approval to market the Anchen Generic Product prior
`
`12
`
`

`
`Case 1:14-cv-00200-LPS Document 1 Filed 02/14/14 Page 13 of 22 PageID #: 13
`Case 1:14—cv—OO200—LPS Document 1 Filed 02/14/14 Page 13 of 22 Page|D #: 13
`
`to the expiration of the ‘009 patent, the '209 patent, the '708 patent, the '379 patent, the ‘752
`
`patent, the ‘085 patent, and the '233 patent.
`
`46.
`
`Pursuant to § 505(j)(2)(A)(vii)(1V) of the Federal Food, Drug and Cosmetic Act,
`
`ANDA No. 205784 alleges that the claims of the ‘O09 patent, the '209 patent, the "708 patent, the
`
`‘379 patent, the ‘752 patent, the ‘085 patent, and the '233 patent are invalid. unenforceable, and/or
`
`will not be infringed by the manufacture, use, or sale of the Anchen Generic Product.
`
`l’]aintil’l‘s
`
`received written notification OFANDA No. 205784 and its § 505(j)(2)(/\)(vii)(lV) allegations on
`
`or about January 7, 2014.
`
`47.
`
`Anchen and Pat's submission of ANDA No. 205784 to the FDA, including its
`
`§ 505(j)(2)(A)(vii)(1V) allegations, constitutes infringement of the '209 patent, the '708 patent,
`
`the ‘379 patent, the ‘752 patent, the ‘085 patent, and 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 '209 patent, the ‘708
`
`patent, the '379 patent, the ‘752 patent, the ‘085 patent. and/or the '233 patent under 35 U.S.C.
`
`§ 27l(a), (b), and/or (c). For purposes of clarity, Plaintiffs state that they are not asserting claims
`
`6-15 ofthe '379 patent against the Anehen Generic Product or any other generic extended release
`
`memantine hydrochloride product that contains memantine hydrochloride as the sole active
`
`ingredient. Relying on the representations set out in Anchen and Par‘s notice of Paragraph IV
`
`Certification regarding ANDA No. 205784 pursuant to 21 U.S.C. § 355(i)(2)(B)(ii) and 2]
`
`C.F.R. § 314.95, Forest does not allege at this time that the Anehen Generic Product infringes the
`
`‘O09 patent. To the extent that discovery in this action demonstrates that assertion of the ‘009
`
`patent against the Anchen Generic Product is warranted, Plaintiffs reserve the right to assert it.
`
`13
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`

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`Case 1:14-cv-00200-LPS Document 1 Filed 02/14/14 Page 14 of 22 PageID #: 14
`Case 1:14—cv—OO200—LPS Document 1 Filed 02/14/14 Page 14 of 22 Page|D #: 14
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`48.
`
`Upon information and belief. each of Anchen and Par has participated in.
`
`contributed to, aided, abetted, and/or induced infringement of the ‘209 patent, the '708 patent, the
`
`'3 79 patent, the '752 patent, the '085 patent, and/or the '233 patent and/or will participate in,
`
`contribute to, aid, abet, and/or induce infringement of the ‘Z09 patent, the '708 patent, the '3 7'9
`
`patent, the '752 patent, the ‘O85 patent, and/or 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 Anehen and Par is jointly and severally liable for the infringement ofthe '209
`
`patent. the "708 patent. the '379 patent, the ‘752 patent, the '085 patent, and/or the '233 patent.
`
`49.
`
`Anchen and Par were aware of the '209 patent. the "208 patent. the '3 79 patent. the
`
`'752 patent, and the ‘O85 patent prior to filing ANDA No. 205784, including its
`
`§ 505(j)(2)(A)(vii)(IV) allegations with respect to those patents.
`
`50.
`
`51.
`
`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 IV — Patent Infringement By Par
`
`52.
`
`Upon information and belief, on or before January 29, 2014. Par submitted
`
`AND/\ No. 205783 to the FDA under § 505 of the Federal Food. Drug and Cosmetic Act (21
`
`U.S.C. § 355(j)). ANDA No. 205783 seeks FDA approval for the commercial manufacture. use.
`
`and sale ofa generic extended release capsule product containing 28 milligrams of memantine
`
`hydrochloride as the active ingredient ("the Par Generic Product"). ANDA No. 205783
`
`specifically seeks FDA approval to market the Par Generic Product prior to the expiration of the
`
`14
`
`

`
`Case 1:14-cv-00200-LPS Document 1 Filed 02/14/14 Page 15 of 22 PageID #: 15
`Case 1:14—cv—OO200—LPS Document 1 Filed 02/14/14 Page 15 of 22 PagelD #: 15
`
`'OO9 patent, the '209 patent, the '708 patent, the '379 patent, the '752 patent, the ‘O85 patent, and
`
`the '233 patent.
`
`53.
`
`Pursuant to § 505(j)(2)(A)(vii)(IV) of the Federal Food. Drug and Cosmetic Act.
`
`ANDA No. 205783 alleges that the claims of the "009 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 infringed by the manufacture, use, or sale ofthe Par Generic Product. Plaintiffs
`
`received written notification ofANDA No. 205783 and its § 505(j)(2)(A)(vii)(IV) allegations on
`
`or about January 30,2014.
`
`54.
`
`Par‘s submission of ANDA No. 205783 to the FDA, including its
`
`§ 505(j)(2)(A)(vii)(IV) allegations, constitutes infringement of the 'OO9 patent, the '209 patent,
`
`the "108 patent. the '379 patent, the '752 patent, the 'O85 patent, and the '233 patent under 35
`
`U.S.C. § 27] (e)(2)(/\). 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 ‘O09 patent. the ‘$209
`
`patent, the ‘708 patent, the '379 patent, the '752 patent, the ‘O85 patent, and/or 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 Par Generic Product or any other generic
`
`extended release memantine hydrochloride product that contains memantine hydrochloride as the
`
`sole active ingredient.
`
`55.
`
`Par was aware of the ‘O09 patent, the '209 patent, the '708 patent, the '3 79 patent,
`
`the '752 patent, and the ‘O85 patent prior to filing ANDA No. 205783, including its
`
`§ 505(i)(2)(A)(vii)(lV) allegations with respect to these patents.
`
`56.
`
`Par‘s actions render this an exceptional case under 35 U .S.C. § 285.
`
`15
`
`

`
`Case 1:14-cv-00200-LPS Document 1 Filed 02/14/14 Page 16 of 22 PageID #: 16
`Case 1:14—cv—OO200—LPS Document 1 Filed 02/14/14 Page 16 of 22 Page|D #: 16
`
`57.
`
`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.
`
`Count V — Patent Infringement By Watson
`
`58.
`
`Upon information and belief, on or before January 27', 2014, Watson submitted
`
`ANDA No. 205813 to the FDA under § 505 of the Federal Food, Drug and Cosmetic Act (21
`
`U.S.C. § 3550)). ANDA No. 205813 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 Watson Generic Products"). ANDA No.
`
`205813 specifically seeks FDA approval to market the Watson Generic Products prior to the
`
`expiration of the ‘009 patent, the '209 patent, the "708 patent, the '379 patent, the ‘752 patent, and
`
`the ‘O85 patent.
`
`59.
`
`Pursuant to § 505(j)(2)(A)(vii)([V) of the Federal Food, Drug and Cosmetic Act.
`
`ANDA No. 205813 alleges that the claims of the '009 patent, the '20‘) patent, the '708 patent, the
`
`'37‘) patent, the '752 patent, and the '085 patent are invalid, unenforceable, andfor will not be
`
`infringed by the manufacture, use, or sale of the Watson Generic Products. Plaintiffs received
`
`written notification ofANDA No. 2058l3 and its § 505(_'|)(2)(A)(vii)(lV) allegations on or about
`
`January 28, 2014.
`
`60.
`
`Watson's submission of ANDA No. 205813 to the FDA. including its
`
`§ 505(j)(2)(A)(vii)(IV) allegations, constitutes infringement of the ‘O09 patent, the '209 patent,
`
`the '708 patent, the '379 patent, the ‘752 patent, and the ‘O85 patent under 35 U.S.C.
`
`§ 2’/1(e)(2)(A). Moreover, if Watson commercially manufactures, uses, offers for sale, or sells
`
`within the United States, or imports into the United States, the Watson Generic Products, or
`
`induces or contributes to any such conduct, it would further infringe the '009 patent, '209 patent,
`
`I6
`
`

`
`Case 1:14-cv-00200-LPS Document 1 Filed 02