Case 1:15-cv-00273-GMS Document 1 Filed 03/27/15 Page 1 of 14 PageID #: 1
`Case 1:15-cv-00273-GMS Document 1 Filed 03/27/15 Page 1 of 14 PagelD #: 1
`
`IN THE UNITED STATES DISTRICT COURT
`
`FOR THE DISTRICT OF DELAWARE
`
`CA. No.
`
`) ) ) ) ) ) ) )
`
`) ) ) ) ) )
`
`)
`
`FOREST LABORATORIES, LLC, FOREST
`LABORATORIES HOLDINGS, LTD.,
`MERCK KGaA and MERCK PATENT
`GESELLSCHAFT MIT BESCHRANKTER
`
`HAFTUNG,
`
`Plaintiffs,
`
`V.
`
`ALEMBIC PHARMACEUTICALS LTD.,
`
`ALEMBIC GLOBAL HOLDING SA, and
`
`ALEMBIC PHARMACEUTICALS, INC.,
`
`Defendants.
`
`COMPLAINT
`
`Plaintiffs Forest Laboratories, LLC and Forest Laboratories Holdings, Ltd. (collectively,
`
`“Forest”), and Merck KGaA and Merck Patent Gesellschaft mit beschrankter Haftung (“Merck
`
`Patent GmbH”) (collectively, “Merck”), by their attorneys, hereby allege as follows:
`
`NATURE OF THE ACTION
`
`1.
`
`This is an action for patent infringement under the patent laws of the United
`
`States, Title 35, United States Code,
`
`that arises out of the filing by Defendant Alembic
`
`Pharmaceuticals Ltd. of Abbreviated New Drug Application (“ANDA”) No. 208202 with the
`
`US. Food and Drug Administration (“FDA”) seeking approval to manufacture and sell a generic
`
`version of Forest’s Viibryd® product prior to the expiration of US. Patent Nos. 7,834,020;
`
`8,193,195; 8,236,804; and 8,673,921.
`
`

`

`Case 1:15-cv-00273-GMS Document 1 Filed 03/27/15 Page 2 of 14 PageID #: 2
`Case 1:15-cv-00273-GMS Document 1 Filed 03/27/15 Page 2 of 14 PagelD #: 2
`
`PARTIES
`
`2.
`
`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 111,
`
`400 Interpace Parkway, Parsippany, New Jersey 07054.
`
`3.
`
`Plaintiff Forest Laboratories Holdings, Ltd.
`
`is an Irish corporation having a
`
`principal place of business at Cumberland House, 1 Victoria Street, Hamilton HM11, Bermuda.
`
`4.
`
`Plaintiff Merck KGaA is a German corporation having a principal place of
`
`business at Frankfurter Str. 250, 64293 Darmstadt Hessen, Germany.
`
`5.
`
`Plaintiff Merck Patent GmbH is a German corporation having a principal place of
`
`business at Frankfurter Str. 250, 64293 Darmstadt Hessen, Germany.
`
`6.
`
`On information and belief, Defendant Alembic Pharmaceuticals Ltd. (“Alembic
`
`Ltd.”) is a corporation organized and existing under the laws of India, having a principal place of
`
`business at Alembic Road, Vadodara 39003, Gujarat, India.
`
`7.
`
`On information and belief, Defendant Alembic Global Holding SA (“Alembic
`
`Global”) is a corporation organized and existing under the laws of Switzerland, having its
`
`principal place of business at Rue Fritz-Courvoisier 40, 2300 La Chaux-de-Fonds, Switzerland.
`
`8.
`
`On information and belief, Defendant Alembic Pharmaceuticals Inc. (“Alembic
`
`Inc.”) is a Delaware corporation, having its principal place of business at 116 Village Boulevard,
`
`Suite 200, Princeton, New Jersey 08650.
`
`JURISDICTION AND VENUE
`
`9.
`
`This action arises under the patent laws of the United States, and this Court has
`
`jurisdiction over the subject matter of this action pursuant to 28 U.S.C. §§ 1331, and 1338(a).
`
`10.
`
`Venue is proper in this district pursuant to 28 U.S.C. §§ 1391 and 1400(b).
`
`

`

`Case 1:15-cv-00273-GMS Document 1 Filed 03/27/15 Page 3 of 14 PageID #: 3
`Case 1:15-cv-00273-GMS Document 1 Filed 03/27/15 Page 3 of 14 PagelD #: 3
`
`11.
`
`This Court has personal jurisdiction over Alembic Ltd., Alembic Global, and
`
`Alembic Inc. (collectively, “Alembic”) because they have engaged in continuous and systematic
`
`contacts with the State of Delaware and/or purposefully availed themselves of this forum by,
`
`among other things, making, marketing, shipping, using, offering to sell or selling, or causing
`
`others to use, offer to sell, or sell, pharmaceutical products in Delaware, and deriving substantial
`
`revenue from such activities.
`
`12.
`
`This Court has personal jurisdiction over Alembic Inc. because, inter alia, it is a
`
`corporation organized and existing under the laws of the State of Delaware.
`
`13.
`
`On information and belief, Defendants Alembic Ltd., Alembic Global, and
`
`Alembic Inc. are in the business of formulating, developing, manufacturing, marketing and/or
`
`selling generic pharmaceutical products that are distributed and sold throughout the United
`
`States, including in the State of Delaware.
`
`14.
`
`On information and belief, Alembic Global
`
`is a wholly-owned subsidiary of
`
`Defendant Alembic Ltd. Alembic Global’s website states, “The basic objective of forming a
`
`wholly owned overseas subsidiary is to expand business globally aiming at purchase, sale,
`
`packaging, manufacturing, research and development of pharmaceutical products, intermediates
`
`and raw materials as well as acquisition and management of Intellectual property. Alembic
`
`Global is the headquarters for all the overseas business in countries like USA, Europe, UAE,
`
`Australia and other developed markets.”
`
`15.
`
`On information and belief, Alembic Inc.
`
`is the United States subsidiary of
`
`Alembic Global. Alembic Inc.’s website states, “The basic objective of forming a wholly owned
`
`overseas subsidiary in USA is to establish a globally recognized organization in USA. Alembic
`
`

`

`Case 1:15-cv-00273-GMS Document 1 Filed 03/27/15 Page 4 of 14 PageID #: 4
`Case 1:15-cv-00273-GMS Document 1 Filed 03/27/15 Page 4 of 14 PagelD #: 4
`
`aims at creating a strong US presence. Alembic has filed 57 ANDAs, received approval for 24
`
`and has commercialized 15 of the approved filings.”
`
`16.
`
`On information and belief, Alembic Inc. is the agent of Alembic Ltd. and Alembic
`
`Global, and it acts in concert with them to manufacture, market, distribute, and sell Alembic’s
`
`generic pharmaceutical products within the United States, including the State of Delaware. On
`
`information and belief, the acts of Defendants Alembic Ltd. and Alembic Global enumerated in
`
`this Complaint were done at the direction of, with the authorization of, with the cooperation,
`
`participation, and/or assistance of, and, in part, for the benefit of Alembic Inc.
`
`17.
`
`On information and belief, Alembic Inc., itself and on behalf of Alembic Ltd. and
`
`Alembic Global, has purposefully conducted business in the State of Delaware, continues to
`
`conduct business in Delaware, and Delaware is a likely destination of Alembic’s products,
`
`including its proposed generic version of Viibryd® that is at issue in this action.
`
`18.
`
`On information and belief, upon approval of Abbreviated New Drug Application
`
`(“ANDA”) No. 208202, Alembic Inc., itself and on behalf of Alembic Ltd. and Alembic Global,
`
`will market and sell vilazodone (10, 20, and 40 mg) tablets (the “Alembic ANDA Product”) in
`
`Delaware and throughout the United States and will derive substantial revenue therefrom.
`
`19.
`
`On information and belief, upon approval of ANDA No. 208202, Alembic Ltd.,
`
`Alembic Global, and Alembic Inc. will place the Alembic ANDA Product into the stream of
`
`commerce with the reasonable expectation or knowledge and the intent that such product will be
`
`purchased and used by consumers in Delaware and throughout the United States.
`
`20.
`
`On information and belief, as a result of its submission of ANDA No. 208202,
`
`Alembic has committed a tortious act of patent infringement under 35 U.S.C. § 271(c)(2) that has
`
`

`

`Case 1:15-cv-00273-GMS Document 1 Filed 03/27/15 Page 5 of 14 PageID #: 5
`Case 1:15-cv-00273-GMS Document 1 Filed 03/27/15 Page 5 of 14 PagelD #: 5
`
`led and/or will lead to foreseeable harm and injury to Plaintiff Forest Laboratories, LLC, a
`
`Delaware company.
`
`21.
`
`Alembic Ltd. has previously availed itself of this forum, for example, by asserting
`
`counterclaims in other civil actions initiated in this jurisdiction. See Sanofi v. Alembic Pharm.
`
`Ltd, CA. No. 14-424-RGA (D. Del.); Teijin Ltd. v. Alembic Pharm. Ltd, CA. No. 13-1939-
`
`SLR (D. Del.); Pfizer Inc. v. Breckenridge Pharm., Inc, CA. No. 12-810-SLR (D. Del.). On
`
`information and belief, Alembic Ltd. has been a defendant in at least nine ANDA suits in the
`
`District of Delaware, and it has not challenged this Court’s exercise of personal jurisdiction over
`
`it in any of those prior actions.
`
`22.
`
`Alembic Global and Alembic Inc. have both waived objections to personal
`
`jurisdiction in the District of Delaware. See Forest Laboratories, LLC v. Alembic Pharm. Ltd,
`
`CA. No. 15-158-SLR (D. Del.).
`
`23.
`
`The Court has personal jurisdiction over Alembic Ltd., Alembic Global, and
`
`Alembic Inc. by virtue of, inter alia, the above-mentioned facts.
`
`24.
`
`In the alternative, this Court may exercise personal jurisdiction over Alembic Ltd.
`
`and Alembic Global pursuant to Federal Rule of Civil Procedure 4(k)(2) because (a) Plaintiffs’
`
`claims arise under federal law; (b) Alembic Ltd. and Alembic Global are foreign companies not
`
`subject to personal jurisdiction in the courts of any state; and (c) Alembic Ltd. and Alembic
`
`Global have sufficient contacts with the United States as a whole, including but not limited to
`
`marketing and/or selling generic pharmaceutical products that are distributed and sold
`
`throughout the United States, such that this Court’s exercise of jurisdiction over Alembic Ltd.
`
`and Alembic Global satisfies due process.
`
`

`

`Case 1:15-cv-00273-GMS Document 1 Filed 03/27/15 Page 6 of 14 PageID #: 6
`Case 1:15-cv-00273-GMS Document 1 Filed 03/27/15 Page 6 of 14 PagelD #: 6
`
`BACKGROUND
`
`25.
`
`United States Patent No. 7,834,020 (“the ’020 patent”), entitled “Polymorphic
`
`Forms
`
`of
`
`1-’4-(5-Cyanoindol-3-YL)Butyl-4-(2-Carbamoylbenzofuran-5-YL)
`
`Piperazine
`
`Hydrochloride” (attached as Exhibit A), was duly and legally issued on November 16, 2010.
`
`26.
`
`United States Patent No. 8,193,195 (“the ’ 195 patent”), entitled “Polymorphic
`
`Forms
`
`of
`
`l-’4-(5-Cyanoindol-3-YL)Butyl-4-(2-Carbamoylbenzofi1ran-5-YL)
`
`Piperazine
`
`Hydrochloride” (attached as Exhibit B), was duly and legally issued on June 5, 2012.
`
`27.
`
`United States Patent No. 8,236,804 (“the ’804 patent”), entitled “Polymorphic
`
`Forms
`
`of
`
`1-’4-(5-Cyanoindol-3-YL)Butyl-4-(2-Carbamoylbenzofi1ran-5-YL)
`
`Piperazine
`
`Hydrochloride” (attached as Exhibit C), was duly and legally issued on August 7, 2012.
`
`28.
`
`United States Patent No. 8,673,921 (“the ’921 patent”), entitled “Polymorphic
`
`Forms
`
`of
`
`1-[4-(5-Cyanoindol-3-YL)Butyl]-4-(2-Carbamoylbenzofuran-5-YL)
`
`Piperazine
`
`Hydrochloride” (attached as Exhibit D), was duly and legally issued on March 18, 2014.
`
`29.
`
`The ’020, ’195, ’804, and ’921 patents, are owned by Merck Patent GmbH, a
`
`wholly owned subsidiary of Plaintiff Merck KGaA. Forest is the exclusive licensee of the ’020,
`
`’195, ’804, and ’921 patents with respect to commercializing pharmaceutical products containing
`
`Vilazodone in the United States.
`
`30.
`
`Viibryd® (Vilazodone HCl) is approved by the FDA for the treatment of major
`
`depressive disorder, and it is available in 10, 20, and 40 mg tablets for oral use.
`
`31.
`
`Forest Laboratories Inc.
`
`(n/k/a Forest Laboratories LLC) holds New Drug
`
`Application (“NDA”) No. 022567, which was approved on January 21, 2011.
`
`32.
`
`The ’020, ’195, ’804, and ’921 patents are all listed in Approved Drug Products
`
`with Therapeutic Equivalence Evaluations, referred to as the “Orange Book,” for Viibryd®.
`
`

`

`Case 1:15-cv-00273-GMS Document 1 Filed 03/27/15 Page 7 of 14 PageID #: 7
`Case 1:15-cv-00273-GMS Document 1 Filed 03/27/15 Page 7 of 14 PagelD #: 7
`
`33.
`
`By letter dated February 25, 2015(the “Notice Letter”), Alembic notified Forest
`
`that it had submitted to the FDA ANDA No. 208202 seeking approval to market and sell the
`
`Alembic ANDA Product in the United States prior to the expiration of the ‘020, ‘ 195, ‘804, and
`
`‘921 patents.
`
`34.
`
`In the Notice Letter, Alembic stated that
`
`its ANDA included certifications
`
`pursuant to 21 U.S.C. § 355(j)(2)(vii)(IV) with respect to the ’020, ’195, ’804, and ’921 patents,
`
`and alleged that these patents are invalid, unenforceable, and/or will not be infringed by the
`
`commercial manufacture, use, offer for sale, or sale of the Alembic ANDA Product in the United
`
`States.
`
`35.
`
`Alembic’s Notice Letter contained an offer of confidential access, the terms of
`
`which the parties have been negotiating in good faith in an effort to reach a mutually-acceptable
`
`agreement, and under which Alembic’s ANDA would be provided to Plaintiffs. The parties have
`
`been unable to reach agreement. Plaintiffs require discovery from Alembic.
`
`36.
`
`This action is being commenced before the expiration of forty-five days from the
`
`date of Forest’s receipt of the Notice Letter.
`
`INFRINGEMENT OF US. PATENT NO. 7,834,020
`
`COUNT I
`
`37.
`
`Plaintiffs incorporate each of the preceding paragraphs 1-36 as if fully set forth
`
`herein.
`
`38.
`
`Alembic’s submission of ANDA No. 208202 for the purpose of obtaining
`
`approval to engage in the commercial import manufacture, use, offer for sale, and/or sale of the
`
`Alembic ANDA Product in the United States before the expiration of the ’020 patent was an act
`
`of infringement of the ’020 patent under 35 U.S.C. § 271(c)(2).
`
`

`

`Case 1:15-cv-00273-GMS Document 1 Filed 03/27/15 Page 8 of 14 PageID #: 8
`Case 1:15-cv-00273-GMS Document 1 Filed 03/27/15 Page 8 of 14 PagelD #: 8
`
`39.
`
`The commercial manufacture, use, offer for sale, sale and/or importation of the
`
`Alembic ANDA Product within the United States would infringe one for more claims of the ’020
`
`patent under 35 U.S.C. § 217(a), (b) and/or (0).
`
`40.
`
`Alembic had knowledge of the ’020 patent prior to submitting its ANDA to the
`
`FDA, including its § 505(j)(2)(A)(vii)(IV) allegation with respect to the ’020 patent.
`
`41.
`
`On information and belief, use of the Alembic ANDA Product in accordance with
`
`and as directed by Alembic’s proposed labeling for that product would infringe one or more
`
`claims of the ’020 patent.
`
`42.
`
`On information and belief, Alembic intends to engage in the manufacture, use,
`
`offer for sale, sale, and/or importation of the Alembic ANDA Product with its proposed labeling
`
`upon approval of ANDA No. 208202.
`
`43.
`
`On information and belief, Alembic will infringe and will actively induce or
`
`contribute to the infringement of the ’020 patent when ANDA No. 208202 is approved, and
`
`plans and intends to, and will do so upon approval.
`
`44.
`
`On information and belief, Alembic acted without a reasonable basis for believing
`
`that it would not be liable for infringing the ’020 patent and/or actively inducing infringement of
`
`the ’020 patent.
`
`45.
`
`Unless Alembic is enjoined from infringing the ’020 patent and/or actively
`
`inducing or contributing to the infringement of the ’020 patent, Plaintiffs will suffer irreparable
`
`injury. Plaintiffs have no adequate remedy at law.
`
`INFRINGEMENT OF U.S. PATENT NO. 8,193,195
`
`COUNT II
`
`46.
`
`Plaintiffs incorporate each of the preceding paragraphs 1-45 as if fully set forth
`
`herein.
`
`

`

`Case 1:15-cv-00273-GMS Document 1 Filed 03/27/15 Page 9 of 14 PageID #: 9
`Case 1:15-cv-00273-GMS Document 1 Filed 03/27/15 Page 9 of 14 PagelD #: 9
`
`47.
`
`Alembic’s submission of ANDA No. 208202 for the purpose of obtaining
`
`approval to engage in the commercial import, manufacture, use, offer for sale, and/or sale of the
`
`Alembic ANDA Product in the United States before the expiration of the ’ 195 patent was an act
`
`of infringement of the ’ 195 patent under 35 U.S.C. § 271(c)(2).
`
`48.
`
`The commercial manufacture, use, offer for sale, sale and/or importation of the
`
`Alembic ANDA Product within the United States would infringe one for more claims of the ’ 195
`
`patent under 35 U.S.C. § 217(a), (b) and/or (0).
`
`49.
`
`Alembic had knowledge of the ’195 patent prior to submitting its ANDA to the
`
`FDA, including its § 5050)(2)(A)(vii)(IV) allegation with respect to the ’ 195 patent.
`
`50.
`
`On information and belief, use of the Alembic ANDA Product in accordance with
`
`and as directed by Alembic’s proposed labeling for that product would infringe one or more
`
`claims of the ’ 195 patent.
`
`51.
`
`On information and belief, Alembic intends to engage in the manufacture, use,
`
`offer for sale, sale, and/or importation of the Alembic ANDA Product with its proposed labeling
`
`upon approval of ANDA No. 208202.
`
`52.
`
`On information and belief, Alembic will infringe and will actively induce or
`
`contribute to the infringement of the ’195 patent when ANDA No. 208202 is approved, and
`
`plans and intends to, and will do so upon approval.
`
`53.
`
`On information and belief, Alembic acted without a reasonable basis for believing
`
`that it would not be liable for infringing the ’ 195 patent and/or actively inducing infringement of
`
`the ’ 195 patent.
`
`

`

`Case 1:15-cv-00273-GMS Document 1 Filed 03/27/15 Page 10 of 14 PageID #: 10
`Case 1:15-cv-00273-GMS Document 1 Filed 03/27/15 Page 10 of 14 PagelD #: 10
`
`54.
`
`Unless Alembic is enjoined from infringing the ’195 patent and/or actively
`
`inducing or contributing to the infringement of the ’195 patent, Plaintiffs will suffer irreparable
`
`injury. Plaintiffs have no adequate remedy at law.
`
`INFRINGEMENT OF US. PATENT NO. 8,236,804
`
`COUNT III
`
`55.
`
`Plaintiffs incorporate each of the preceding paragraphs 1-54 as if fully set forth
`
`herein.
`
`56.
`
`Alembic’s submission of ANDA No. 208202 for the purpose of obtaining
`
`approval to engage in the commercial import manufacture, use, offer for sale, and/or sale of the
`
`Alembic ANDA Product in the United States before the expiration of the ’804 patent was an act
`
`of infringement of the ’804 patent under 35 U.S.C. § 271(c)(2).
`
`57.
`
`The commercial manufacture, use, offer for sale, sale and/or importation of the
`
`Alembic ANDA Product within the United States would infringe one for more claims of the ’804
`
`patent under 35 U.S.C. § 217(a), (b) and/or (c).
`
`58.
`
`Alembic had knowledge of the ’804 patent prior to submitting its ANDA to the
`
`FDA, including its § 5050)(2)(A)(vii)(IV) allegation with respect to the ’804 patent.
`
`59.
`
`On information and belief, use of the Alembic ANDA Product in accordance with
`
`and as directed by Alembic’s proposed labeling for that product would infringe one or more
`
`claims of the ’804 patent.
`
`60.
`
`On information and belief, Alembic intends to engage in the manufacture, use,
`
`offer for sale, sale, and/or importation of the Alembic ANDA Product with its proposed labeling
`
`upon approval of ANDA No. 208202.
`
`10
`
`

`

`Case 1:15-cv-00273-GMS Document 1 Filed 03/27/15 Page 11 of 14 PageID #: 11
`Case 1:15-cv-00273-GMS Document 1 Filed 03/27/15 Page 11 of 14 PagelD #: 11
`
`61.
`
`On information and belief, Alembic will infringe and will actively induce or
`
`contribute to the infringement of the ’804 patent when ANDA No. 208202 is approved, and
`
`plans and intends to, and will do so immediately and imminently upon approval.
`
`62.
`
`On information and belief, Alembic acted without a reasonable basis for believing
`
`that it would not be liable for infringing the ’804 patent and/or actively inducing infringement of
`
`the ’804 patent.
`
`63.
`
`Unless Alembic is enjoined from infringing the ’804 patent and/or actively
`
`inducing or contributing to the infringement of the ’804 patent, Plaintiffs will suffer irreparable
`
`injury. Plaintiffs have no adequate remedy at law.
`
`INFRINGEMENT OF US. PATENT NO. 8,673,921
`
`COUNT IV
`
`64.
`
`Plaintiffs incorporate each of the preceding paragraphs 1-63 as if fully set forth
`
`herein.
`
`65.
`
`Alembic’s submission of ANDA No. 208202 for the purpose of obtaining
`
`approval to engage in the commercial import, manufacture, use, offer for sale, and/or sale of the
`
`Alembic ANDA Product in the United States before the expiration of the ’921 patent was an act
`
`of infringement of the ’921 patent under under 35 U.S.C. § 271(e)(2).
`
`66.
`
`The commercial manufacture, use, offer for sale, sale and/or importation of the
`
`Alembic ANDA Product within the United States would infringe one for more claims of the ’921
`
`patent under 35 U.S.C. § 217(a), (b) and/or (c).
`
`67.
`
`Alembic had knowledge of the ’921 patent prior to submitting its ANDA to the
`
`FDA, including its § 5050)(2)(A)(Vii)(IV) allegation with respect to the ’921 patent.
`
`11
`
`

`

`Case 1:15-cv-00273-GMS Document 1 Filed 03/27/15 Page 12 of 14 PageID #: 12
`Case 1:15-cv-00273-GMS Document 1 Filed 03/27/15 Page 12 of 14 PagelD #: 12
`
`68.
`
`On information and belief, use of the Alembic ANDA Product in accordance with
`
`and as directed by Alembic’s proposed labeling for that product would infringe one or more
`
`claims of the ’921 patent.
`
`69.
`
`On information and belief, Alembic intends to engage in the manufacture, use,
`
`offer for sale, sale, and/or importation of the Alembic ANDA Product with its proposed labeling
`
`upon approval of ANDA No. 208202.
`
`70.
`
`On information and belief, Alembic will infringe and will actively induce or
`
`contribute to the infringement of the ’921 patent when ANDA No. 208202 is approved, and
`
`plans and intends to, and will do so upon approval.
`
`71.
`
`On information and belief, Alembic acted without a reasonable basis for believing
`
`that it would not be liable for infringing the ’921 patent and/or actively inducing infringement of
`
`the ’921 patent.
`
`72.
`
`Unless Alembic is enjoined from infringing the ’921 patent and/or actively
`
`inducing or contributing to the infringement of the ’921 patent, Plaintiffs will suffer irreparable
`
`injury. Plaintiffs have no adequate remedy at law.
`
`PRAYER FOR RELIEF
`
`WHEREFORE, Plaintiffs prays that this Court grant the following relief:
`
`(a)
`
`A judgment that Alembic’s submission of ANDA No. 208202 was an act
`
`of infringement of one or more claims of the ’020, ’195, ’804, and ’921 patents, and that
`
`Alembic’s manufacture, use, offer to sell, sale, or importation of the Alembic ANDA Product in
`
`the United States prior to the expiration of the ’020, ’195, ’804, and ’921 patents, will infringe
`
`and/or actively induce or contribute to the infringement of the one or more claims of the ’020,
`
`’195, ’804, and ’921 patents;
`
`12
`
`

`

`Case 1:15-cv-00273-GMS Document 1 Filed 03/27/15 Page 13 of 14 PageID #: 13
`Case 1:15-cv-00273-GMS Document 1 Filed 03/27/15 Page 13 of 14 PagelD #: 13
`
`(b)
`
`An Order pursuant to 35 U.S.C. § 271(e)(4)(A) providing that the effective
`
`date of any FDA approval of Alembic’s ANDA No. 208202, shall not be earlier than the latest
`
`expiration date of the ’020, ’195,
`
`’804, and ’921 patents,
`
`including any extensions and/or
`
`additional periods of exclusivity to which Plaintiffs are or become entitled;
`
`(c)
`
`An Order permanently enjoining Alembic,
`
`and its
`
`affiliates
`
`and
`
`subsidiaries, and each of its officers, agents, servants, and employees, from making, having
`
`made, using, offering to sell, selling, marketing, distributing, or importing in or into the United
`
`States the Alembic ANDA Product, or any product or compound that infringes the ’020, ’195,
`
`’804, and ’921 patents, or inducing the infringement of the ’020, ’195, ’804, and ’921 patents,
`
`until after the latest expiration date of the ’020, ’195, ’804, and ’921 patents, including any
`
`extensions and/or additional periods of exclusivity to which Plaintiffs are or become entitled;
`
`(d)
`
`A declaration that this is an exceptional case and an award of attorneys’
`
`fees to Plaintiffs pursuant to 35 U.S.C. §§ 285 and 271(e)(4), together with reasonable costs; and
`
`(6)
`
`Such further and other relief as this Court deems proper and just.
`
`13
`
`

`

`Case 1:15-cv-00273-GMS Document 1 Filed 03/27/15 Page 14 of 14 PageID #: 14
`Case 1:15-cv-00273-GMS Document 1 Filed 03/27/15 Page 14 of 14 PagelD #: 14
`
`OF COUNSEL:
`
`David B. Bassett
`
`David Manspeizer
`WILMER CUTLER PICKERING
`HALE & DORR LLP
`
`7 World Trade Center
`
`250 Greenwich Street
`
`New York, NY 10007
`(212) 230-8800
`
`Vinita Ferrera
`
`Emily R. Whelan
`Andrej Barbie
`Anna Lumelsky
`Shira Hoffman
`
`WILMER CUTLER PICKERING
`HALE & DORR LLP
`
`60 State Street
`
`Boston, MA 02109
`(617) 526-6000
`
`March 27, 2015
`
`MORRIS, NICHOLS, ARSHT & TUNNELL LLP
`
`Mama
`
`
`
`#1014)
`Jack B.
`lumenfei
`Maryellen Noreika (#3208)
`1201 North Market Street
`
`
`
`PO. Box 1347
`
`Wilmington, DE 19899
`(302) 658-9200
`jblumenfeld@mnat.com
`mnoreika@mnat.com
`
`Attorneys for Plaintififs‘ Forest Laboratories,
`LLC, Forest Laboratories Holdings, Ltd.,
`Merck KGaA and Merck Patent GmbH
`
`14
`
`