Warner Chilcott Company v. Lupin et. al.

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Official Complaint for Patent Infringement in Civil Action No. 3:11-cv-07228-JAP-DEA: Warner Chilcott Company, LLC v. Lupin Ltd. et. al. Filed in U.S. District Court for the District of New Jersey, the Hon. Joel A. Pisano presiding. See http://news.priorsmart.com/-l4WR for more info.
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    ME1 12667411v.1  William J. O’ShaughnessyM C CARTER & ENGLISH, LLPFour Gateway Center100 Mulberry St.Newark, NJ 07102Tel: (973) 622-4444Fax: (973) 624-7070OF COUNSEL:Dominick A. CondeBrian V. SlaterFilko PrugoJoanna Garelick GoldsteinFITZPATRICK, CELLA, HARPER& SCINTO1290 Avenue of the AmericasNew York, NY 10104Tel: (212) 218-2100Fax: (212) 218-2200  Attorneys for Plaintiff Warner Chilcott Company, LLC  IN THE UNITED STATES DISTRICT COURTFOR THE DISTRICT OF NEW JERSEY WARNER CHILCOTT COMPANY, LLC,Plaintiff,v.LUPIN LTD. and LUPINPHARMACEUTICALS, INC.,Defendants.)))))))))))C. A. No. COMPLAINT FOR PATENT INFRINGEMENT    ME1 12667411v.1 2Plaintiff Warner Chilcott Company, LLC, by its undersigned attorneys, brings thisaction against Defendants Lupin Ltd. and Lupin Pharmaceuticals, Inc. (collectively “Lupin”),and hereby alleges as follows: THE PARTIES 1.   Plaintiff Warner Chilcott Company, LLC (“Warner Chilcott”) is a limitedliability company organized and existing under the laws of Puerto Rico, having offices at UnionSt., Road 195, Km 1.1, Fajardo, Puerto Rico.2.   Upon information and belief, Defendant Lupin Limited (“Lupin Ltd.”) is acorporation organized and existing under the laws of India.3.   Upon information and belief, Defendant Lupin Pharmaceuticals, Inc.(“LPI”) is a wholly-owned subsidiary of Lupin Ltd. and is a corporation organized and existingunder the laws of the Commonwealth of Virginia. LPI has a principal place of business locatedat 111 S. Calvert Street, 21 st Floor, Baltimore, MD 21202.4.   Upon information and belief, LPI is doing business in New Jersey, isregistered to do business in New Jersey, has engaged in continuous and systemic contacts withNew Jersey, and purposefully availed itself of this forum by, among other things, shipping,using, offering to sell, selling, or causing others to use, offer to sell or sell pharmaceuticalproducts in New Jersey and deriving substantial revenue from such activities.5.   Upon information and belief, Lupin Ltd. has engaged in continuous andsystemic contacts with the United States by, among other things, filing with the United StatesFood and Drug Administration Abbreviated New Drug Applications to sell various products inthe United States. Upon information and belief, Lupin Ltd. manufactures generic drug productsfor sale and use in the United States, including in this judicial district.    ME1 12667411v.1 36.   Upon information and belief, Lupin Ltd. and LPI are agents of each otherwith respect to the development, regulatory approval, marketing, sale and/or distribution of generic pharmaceutical products. Upon information and belief, the acts of Lupin Ltd.complained of herein were done and are being done with the cooperation, participation andassistance of, and at least in part for the benefit of, LPI.7.   Lupin Ltd. and LPI have previously availed themselves of the U.S. DistrictCourt for the District of New Jersey by, inter alia , filing litigation and asserting counterclaims inthis District. JURISDICTION AND VENUE 8.   This is an action for patent infringement arising under the patent laws of the United States, Title 35, United States Code. This Court has subject matter jurisdiction overthis action based on 28 U.S.C. §§ 1331 and 1338(a).9.   This Court has personal jurisdiction over LPI by virtue of the fact that itconducts business in the State of New Jersey, has purposefully availed itself of the rights andbenefits of New Jersey law and this Court, and has engaged in substantial and continuingcontacts with the State by selling a range of generic pharmaceutical products within the UnitedStates generally and New Jersey specifically.10.   This Court has personal jurisdiction over Lupin Ltd. at least under FederalRule of Civil Procedure 4(k)(2).11.   Venue is proper in this Court under 28 U.S.C. §§ 1391(b), (c) and (d) and1400(b).    ME1 12667411v.1 4 COUNT ICLAIM FOR INFRINGEMENT OF THE ‘050 PATENT 12.   Watson Labs. Inc. is the holder of New Drug Application (“NDA”) No.22-573 for Generess TM Fe, which contains the active ingredients norethindrone and ethinylestradiol. Generess TM Fe was approved by the United States Food and Drug Administration(“FDA”) on December 22, 2010, and is indicated for the prevention of pregnancy in women whoelect to use it as a method of contraception. Generess TM Fe is sold as a 28-day oral contraceptiveregimen that includes 24 chewable tablets comprising 0.8 mg norethindrone and 0.025 mgethinyl estradiol, and 4 chewable ferrous fumarate tablets (placebo).13.   U.S. Patent No. 6,667,050 ( “the ‘050 patent”) entitled “Chewable OralContraceptive” lawfully issued by the United States Patent and Trademark Office on December23, 2003. A copy of the ‘050 patent is attached as Exhibit A.14.   Warner Chilcott is the sole owner of the ‘050 patent.15.   The ‘050 patent claims, among other things, a chewable, palatable oralcontraceptive tablet, a method of administering said tablet to a human female and a method of enhancing compliance with the oral contraception regimen.16.   The ‘050 patent covers the use of Generess TM Fe in accordance with thelabeling approved by the FDA and is listed in the FDA  Approved Drug Products withTherapeutic Equivalence Evaluations (“the Orange Book”) for that product.17.   Upon information and belief, Lupin submitted to the FDA an AbbreviatedNew Drug Application (“ANDA”) filed under 21 U.S.C. § 355(j), to obtain approval to engagein the commercial manufacture, use, or sale of a generic version of Generess TM Fe prior to theexpiration of the ‘050 patent.
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