Case 1:14-cv-01104-RGA Document 1 Filed 08/27/14 Page 1 of 11 PageID #: 1
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
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`C.A. No. ____________
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`NOVARTIS PHARMACEUTICALS
`CORPORATION, NOVARTIS AG,
`NOVARTIS PHARMA AG and LTS
`LOHMANN THERAPIE-SYSTEME AG
`
` Plaintiffs,
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`
`
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`v.
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`ZYDUS NOVELTECH INC., ZYDUS
`PHARMACEUTICALS (USA) INC. and
`CADILA HEALTHCARE LTD. (d/b/a
`ZYDUS CADILA)
`
` Defendants.
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`
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`
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`COMPLAINT FOR PATENT INFRINGEMENT
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`Plaintiffs Novartis Pharmaceuticals Corporation, Novartis AG, Novartis Pharma
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`AG and LTS Lohmann Therapie-Systeme AG, for their Complaint against defendants Zydus
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`Noveltech Inc., Zydus Pharmaceuticals (USA) Inc., and Cadila Healthcare Ltd. allege as follows:
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`NATURE OF ACTION
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`This is an action for patent infringement.
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`PARTIES
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`Plaintiff Novartis Pharmaceuticals Corporation (“NPC”) is a corporation
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`1.
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`2.
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`organized and existing under the laws of the State of Delaware, having a principal place of
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`business at 59 Route 10, East Hanover, New Jersey 07936.
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`3.
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`Plaintiff Novartis AG (“Novartis AG”) is a corporation organized and
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`existing under the laws of Switzerland, having an office and place of business at Lichtstrasse 35,
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`CH-4056 Basel, Switzerland.
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`4.
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`Plaintiff Novartis Pharma AG (“Pharma AG”) is a corporation organized
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`and existing under the laws of Switzerland, having an office and place of business at Lichtstrasse
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`35, CH-4056 Basel, Switzerland.
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`5.
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`Plaintiff LTS Lohmann Therapie-Systeme AG (“LTS”) is a corporation
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`organized and existing under the laws of Germany, having an office and place of business at
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`Lohmannstraße 2, D-56626 Andernach, Germany.
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`6.
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`On information and belief, defendant Zydus Noveltech Inc. (“Zydus
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`Noveltech”) is a corporation organized and existing under the laws of the State of New Jersey
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`with a principal place of business at 1775 Williston Road, Suite 210, So. Burlington, VT, 05403.
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`7.
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`On information and belief, defendant Zydus Pharmaceuticals (USA) Inc.
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`(“Zydus Pharmaceuticals”) is a corporation organized and existing under the laws of the State of
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`New Jersey, with a principal place of business located at 73 Route 31 N., Pennington, NJ 08534.
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`8.
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`On information and belief, defendant Cadila Healthcare Ltd. (d/b/a Zydus
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`Cadila) (“Cadila”) is a corporation organized and existing under the laws of India, having a
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`principal place of business at Zydus Tower, Satellite Cross Roads, Ahmedabad-380015 Gujarat,
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`India. On information and belief, Zydus International Private Ltd., a wholly-owned subsidiary of
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`Cadila, owns 85% of Zydus Noveltech. On information and belief, Zydus Pharmaceuticals is a
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`wholly-owned subsidiary of Zydus International Private Ltd.
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`9.
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`On information and belief, the acts of Zydus Noveltech complained of
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`herein were done at the direction of, with the authorization of, and with the cooperation,
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`participation, and assistance of Zydus Pharmaceuticals and Cadila.
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`10.
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`Defendants Zydus Noveltech, Zydus Pharmaceuticals, and Cadila are
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`referred to collectively herein as “Zydus.”
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`JURISDICTION AND VENUE
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`11.
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`This action arises under the patent laws of the United States of America.
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`This Court has jurisdiction over the subject matter of this action under 28 U.S.C. §§ 1331,
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`1338(a), 2201 and 2202.
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`12.
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`On information and belief, Zydus Noveltech is involved in the
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`development, manufacture, marketing, sale, and distribution of generic pharmaceuticals. On
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`information and belief, Zydus Noveltech, Zydus Pharmaceuticals, and Cadila each act as agents
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`of each other and/or work in concert with each other to further the aims of Cadila. On
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`information and belief, Zydus Noveltech, which is responsible for, inter alia, developing and
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`submitting abbreviated new drug applications (“ANDAs”) to the U.S. Food and Drug
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`Administration (“FDA”), relies on contributions from Zydus Pharmaceuticals and Cadila.
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`13.
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`On information and belief, Zydus Pharmaceuticals is the United States
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`division of Cadila. On information and belief, Zydus Noveltech acts on behalf of Cadila in the
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`United States to develop and market drug products.
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`14.
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`On information and belief, Zydus Noveltech, Zydus Pharmaceuticals, and
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`Cadila are in the business of manufacturing, marketing, importing into the United States and/or
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`selling pharmaceutical drug products, including generic drug products. On information and
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`belief, Cadila and Zydus Noveltech directly or through their affiliates and agents, including
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`Zydus Pharmaceuticals, market and sell drug products throughout the United States and in this
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`judicial district, and have purposely availed themselves of the rights and benefits of Delaware
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`law and this Court.
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`15.
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`On information and belief, Zydus Noveltech, Zydus Pharmaceuticals, and
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`Cadila share common directors.
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`16.
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`This Court has personal jurisdiction over Zydus Pharmaceuticals and
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`Cadila because they have affirmatively availed themselves of the jurisdiction of this Court by
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`filing counterclaims in this district, and have previously been sued in this district and have not
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`challenged personal jurisdiction. See, e.g., Forest Labs., Inc. et al. v. Apotex Corp. et al., 1:14-
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`cv-00200 (D. Del.) (defendants and counterclaimants); UCB, Inc. et al. v. Zydus Pharms. (USA)
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`Inc. et al., 1:13-cv-01220 (D. Del.) (defendants and counterclaimants); Pfizer Inc. et al. v. Zydus
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`Pharms. (USA) Inc. et al., 1:12-cv-00808 (D. Del.) (defendants and counterclaimants); Abbott
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`Labs. et al. v. Cadila Healthcare Ltd. et al., 1:12-cv-00065 (D. Del.) (defendants and
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`counterclaimants); Warner Chilcott Co. v. Zydus Pharms. (USA) Inc., 1:11-cv-01105 (D. Del.)
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`(defendants and counterclaimants); Somaxon Pharms., Inc. et al. v. Zydus Pharms. USA, Inc. et
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`al., 1:11-cv-00537 (D. Del.) (defendants and counterclaimants); Shire Dev. Inc. et al. v. Cadila
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`Healthcare Ltd. et al., 1:10-cv-00581 (D. Del.) (defendants and counterclaimants); Wyeth v.
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`Cadila Healthcare Ltd. et al., 1:09-cv-00239 (D. Del.) (defendants and counterclaimants); Teijin
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`Ltd. et al. v. Zydus Pharms. (USA), Inc. et al, 1:13-cv-02086 (D. Del.) (defendants); Alpex
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`Pharma, S.A. et al. v. Zydus Pharms. (USA) Inc. et al., 1:13-cv-01143 (D. Del.) (defendants).
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`17.
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`For these reasons, and for other reasons that will be presented to the Court
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`if jurisdiction is challenged, the Court has personal jurisdiction over Zydus.
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`18.
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`Venue is proper in this Court pursuant to 28 U.S.C. §§ 1391(b) and (c) and
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`28 U.S.C. § 1400(b).
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`CLAIM FOR RELIEF – PATENT INFRINGEMENT
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`19.
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`Plaintiff NPC holds an approved new drug application (“NDA”) No. 22-
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`
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`083 for Exelon® Patch (rivastigmine transdermal system or extended release film) (4.6 mg/24 hr,
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`9.5 mg/24 hr and 13.3 mg/24 hr dosage strengths), which patch contains the active ingredient
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`rivastigmine. Exelon®
` Patch (4.6 mg/24 hr and 9.5 mg/24 hr dosage strengths) was approved by
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`the FDA on July 6, 2007, and Exelon® Patch (13.3 mg/24 hr dosage strength) was approved by
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`the FDA on August 31, 2012. Exelon® Patch is indicated for the treatment of mild to moderate
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`dementia of the Alzheimer’s type and mild to moderate dementia associated with Parkinson’s
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`disease. Exelon® Patch (4.6 mg/24 hr, 9.5 mg/24 hr and 13.3 mg/24 hr dosage strengths) is sold
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`in the United States by Plaintiff NPC.
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`20.
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`Rivastigmine is known chemically as (S)-N-ethyl-3-[(1-
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`dimethylamino)ethyl]-N-methylphenyl-carbamate.
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`21.
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`Plaintiffs Novartis AG and LTS are the owners of United States Letters
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`Patent No. 6,316,023 (“the ‘023 patent”). The ‘023 patent was duly and legally issued on
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`November 13, 2001.
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`22.
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`The ‘023 patent claims pharmaceutical compositions, inter alia,
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`comprising 1 to 40 weight percent of (S)-N-ethyl-3-[(1-dimethylamino)ethyl]-N-methylphenyl-
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`carbamate in the form of a free base or acid addition salt, 0.01 to 0.5 weight percent of an
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`antioxidant, and a diluent or carrier, wherein the weight percents are based on the total weight of
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`the pharmaceutical composition, as well as transdermal devices. A true copy of the ‘023 patent
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`is attached hereto as Exhibit A.
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`23.
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`Plaintiffs Novartis AG and LTS are the owners of United States Letters
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`Patent No. 6,335,031 (“the ‘031 patent”). The ‘031 patent was duly and legally issued on
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`January 1, 2002.
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`24.
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`The ‘031 patent claims pharmaceutical compositions, inter alia,
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`comprising: (a) a therapeutically effective amount of (S)-N-ethyl-3-[(1-dimethylamino)ethyl]-N-
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`methylphenyl-carbamate in free base or acid addition salt form; (b) about 0.01 to about 0.5
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`percent by weight of an antioxidant, based on the weight of the composition, and (c) a diluent or
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`carrier, as well as transdermal devices and methods of stabilizing (S)-N-ethyl-3-[(1-
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`dimethylamino)ethyl]-N-methylphenyl-carbamate in free base or acid addition salt form. A true
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`copy of the ‘031 patent is attached hereto as Exhibit B.
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`25.
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`The ‘023 and ‘031 patents were initially assigned to Novartis AG and LTS
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`Lohmann Therapie-Systeme GmbH & Co. KG, which subsequently changed its legal form to
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`become Plaintiff LTS.
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`26.
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`On information and belief, Defendant Zydus submitted to the FDA an
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`abbreviated new drug application (“ANDA”) under the provisions of 21 U.S.C. § 355(j) seeking
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`approval to engage in the commercial manufacture, use, and sale of a rivastigmine transdermal
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`system, 4.6 mg/24 hr, 9.5 mg/24 hr and 13.3 mg/24 hr dosage strengths (“Zydus’s ANDA
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`Products”) before the expiration of the ‘023 and ‘031 patents.
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`27.
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`On information and belief, Zydus made and included in its ANDA a
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`certification under 21 U.S.C. § 355(j)(2)(A)(vii)(IV) that, in its opinion and to the best of its
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`knowledge, the ‘023 and ‘031 patents are invalid and/or will not be infringed. Zydus did not
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`allege that any of the ‘023 or ‘031 patent claims were unenforceable.
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`28.
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`Plaintiffs received written notification of Zydus’s ANDA and its
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`accompanying 21 U.S.C. § 355(j)(2)(A)(vii)(IV) certification by a letter dated July 16, 2014
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`(“Notice Letter”).
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`Letter.
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`29.
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`30.
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`This action was commenced within 45 days of receipt of Zydus’s Notice
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`By filing its ANDA under 21 U.S.C. § 355(j) for the purpose of obtaining
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`approval to engage in the commercial manufacture, use, or sale of Zydus’s ANDA Products
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`before the expiration of the ‘023 and ‘031 patents, Zydus has committed an act of infringement
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`under 35 U.S.C. § 271(e)(2).
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`31.
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`On information and belief, when Zydus filed its ANDA, it was aware of
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`the ‘023 and ‘031 patents and that the filing of its ANDA with the request for its approval prior
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`to the expiration of the ‘023 and ‘031 patents was an act of infringement of those patents.
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`32.
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`On information and belief, the commercial manufacture, use, offer for
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`sale, sale and/or importation of Zydus’s ANDA Products will infringe and/or induce
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`infringement of one or more claims of the ‘023 and ‘031 patents.
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`33.
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`On information and belief, Zydus’s ANDA Products, if approved, will
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`comprise a pharmaceutical composition. Zydus, in its Notice Letter, did not deny that its ANDA
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`Products, if approved, will contain a pharmaceutical composition.
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`34.
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`On information and belief, Zydus’s ANDA Products, if approved, will be
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`transdermal devices. Zydus, in its Notice Letter, did not deny that its ANDA Products, if
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`approved, will be transdermal devices.
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`35.
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`On information and belief, Zydus’s ANDA Products, if approved, will
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`comprise a pharmaceutical composition comprising (S)-N-ethyl-3-[(1-dimethylamino)ethyl]-N-
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`methylphenyl-carbamate in the form of a free base (“rivastigmine”). On information and belief,
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`Zydus’s ANDA Products, if approved, will comprise a pharmaceutical composition comprising 1
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`to 40 weight percent of rivastigmine, wherein the weight percent is based on the total weight of
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`the pharmaceutical composition. On information and belief, Zydus’s ANDA Products, if
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`approved, will comprise a pharmaceutical composition comprising a therapeutically effective
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`amount of rivastigmine. Zydus, in its Notice Letter, did not deny that its ANDA Products, if
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`approved, will contain rivastigmine or the claimed amounts of rivastigmine.
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`36.
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`On information and belief, Zydus’s ANDA Products, if approved, will
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`contain an antioxidant. Zydus, in its Notice Letter, did not deny that its ANDA Products, if
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`approved, will contain an antioxidant.
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`37.
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`On information and belief, Zydus’s ANDA Products, if approved, will
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`contain butylhydroxytoluene.
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`38.
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`On information and belief, Zydus’s ANDA Products, if approved, will
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`comprise a pharmaceutical composition comprising 0.01 to 0.5 weight percent of an antioxidant
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`wherein the weight percent is based on the total weight of the pharmaceutical composition. On
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`information and belief, Zydus’s ANDA Products, if approved, will comprise a pharmaceutical
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`composition comprising about 0.01 to about 0.5 percent by weight of an antioxidant, based on
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`the weight of the pharmaceutical composition.
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`39.
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`On information and belief, Zydus’s ANDA Products, if approved, will
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`comprise a pharmaceutical composition comprising a diluent or carrier. Zydus, in its Notice
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`Letter, did not deny that its ANDA Products, if approved, will contain a diluent or carrier.
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`40.
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` On information and belief, Zydus’s ANDA Products, if approved, will
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`contain an amount of antioxidant effective to stabilize rivastigmine from oxidative degradation.
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`41.
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`On information and belief, Zydus, if its ANDA Products are approved,
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`will practice a method of forming a composition by combining rivastigmine with an antioxidant.
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`42.
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`On information and belief, the commercial manufacture of Zydus’s
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`ANDA Products will involve direct infringement of the ‘023 patent. On information and belief,
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`this will occur at Zydus’s active behest, and with Zydus’s intent, knowledge and encouragement.
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`On information and belief, Zydus will actively induce, encourage and abet this infringement with
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`knowledge that it is in contravention of the rights under the ‘023 patent.
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`43.
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`On information and belief, the commercial manufacture of Zydus’s
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`ANDA Products will involve direct infringement of the ‘031 patent. On information and belief,
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`this will occur at Zydus’s active behest, and with Zydus’s intent, knowledge and encouragement.
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`On information and belief, Zydus will actively induce, encourage and abet this infringement with
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`knowledge that it is in contravention of the rights under the ‘031 patent.
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`44.
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`Plaintiffs are entitled to the relief provided by 35 U.S.C. § 271(e)(4),
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`including an order of this Court that the effective date of any approval of the aforementioned
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`ANDA relating to Zydus’s ANDA Products be a date that is not earlier than January 8, 2019, the
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`expiration date of the ‘023 and ‘031 patents, and an award of damages for any commercial sale
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`or use of Zydus’s ANDA Products and any act committed by Zydus with respect to the subject
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`matter claimed in the ‘023 and ‘031 patents, which act is not within the limited exclusions of 35
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`U.S.C. § 271(e)(1).
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`45.
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`On information and belief, Zydus has taken and continues to take active
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`steps towards the commercial manufacture, use, offer for sale, sale and/or importation of Zydus’s
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`ANDA Products, including seeking approval of that product under Zydus’s ANDA.
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`46.
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`There is a substantial and immediate controversy between Plaintiffs and
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`Zydus concerning the ‘023 and ‘031 patents. Plaintiffs are entitled to declaratory judgment
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`under 28 U.S.C. §§ 2201 and 2202 that Zydus will infringe and/or induce infringement of one or
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`more claims of the ‘023 and ‘031 patents.
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`PRAYER FOR RELIEF
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`WHEREFORE, Plaintiffs respectfully request the following relief:
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`A.
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`Judgment that Zydus has infringed and induced infringement of one or
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`more claims of the ‘023 and ‘031 patents by filing the aforesaid ANDA relating to Zydus’s
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`rivastigmine transdermal system, 4.6 mg/24 hr, 9.5 mg/24 hr and 13.3 mg/24 hr dosage
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`strengths;
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`B.
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`A permanent injunction restraining and enjoining Zydus and its officers,
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`agents, attorneys and employees, and those acting in privity or concert with it, from engaging in
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`the commercial manufacture, use, offer to sell, or sale within the United States, or importation
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`into the United States, of a rivastigmine transdermal system, 4.6 mg/24 hr, 9.5 mg/24 hr and 13.3
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`mg/24 hr dosage strengths, as claimed in the ‘023 and ‘031 patents;
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`C.
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`An order that the effective date of any approval of the aforementioned
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`ANDA relating to Zydus’s rivastigmine transdermal system, 4.6 mg/24 hr, 9.5 mg/24 hr and 13.3
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`mg/24 hr dosage strengths, be a date that is not earlier than the expiration of the right of
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`exclusivity under the ‘023 and ‘031 patents;
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`D.
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`Declaratory judgment that the commercial manufacture, use, offer for sale,
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`sale and/or importation of Zydus’s rivastigmine transdermal system, 4.6 mg/24 hr, 9.5 mg/24 hr
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`and 13.3 mg/24 hr dosage strengths, will infringe one or more claims of the ‘023 and ‘031
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`patents and that Zydus will induce infringement of one or more claims of the ‘023 and ‘031
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`patents;
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`E.
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`Damages from Zydus for the infringement and inducement of
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`infringement of the ‘023 and ‘031 patents;
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`F.
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`The costs and reasonable attorney fees of Plaintiffs in this action; and
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`G.
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`Such other and further relief as the Court may deem just and proper.
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`Dated: August 27, 2014
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`McCARTER & ENGLISH, LLP
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`/s/ Daniel M. Silver
`Michael P. Kelly (#2295)
`Daniel M. Silver (#4758)
`Renaissance Centre
`405 N. King Street, 8th Floor
`Wilmington, Delaware 19801
`(302) 984-6300
`mkelly@mccarter.com
`dsilver@mccarter.com
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`Attorneys for Plaintiffs
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`OF COUNSEL:
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`Nicholas N. Kallas
`Christopher E. Loh
`Charlotte Jacobsen
`FITZPATRICK, CELLA, HARPER
` & SCINTO
`1290 Avenue of the Americas
`New York, NY 10104-3800
`(212) 218-2100
`
`
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