Case 1:15-cv-00078-RGA Document 1 Filed 01/23/15 Page 1 of 9 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 and NOVARTIS AG,
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`Plaintiffs,
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`v.
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`PAR PHARMACEUTICAL, INC.
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`Defendant.
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`COMPLAINT FOR PATENT INFRINGEMENT
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`Plaintiffs Novartis Pharmaceuticals Corporation and Novartis AG (hereinafter
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`“Plaintiffs”), for their Complaint against defendant Par Pharmaceutical, Inc. 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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`On information and belief, defendant Par Pharmaceutical, Inc. (“Par”) is a
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`corporation organized and existing under the laws of the State of Delaware, and having
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`designated its registered agent as The Corporation Trust Company, Corporation Trust Center,
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`1209 Orange Street, Wilmington, Delaware 19801. Upon information and belief, defendant Par
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`has its primary place of business at One Ram Ridge Road, Spring Valley, New York 10977.
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`Upon information and belief, defendant Par develops, manufactures, markets and distributes
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`numerous generic drugs for sale and use throughout the United States, including in this judicial
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`district.
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`JURISDICTION AND VENUE
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`5.
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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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`6.
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`On information and belief, Par is in the business of developing,
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`manufacturing, marketing, and selling pharmaceutical drug products, including generic drug
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`products. On information and belief, Par directly or through its affiliates and agents markets and
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`sells drug products throughout the United States and in this judicial district, is incorporated in
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`Delaware, has a registered agent for service in Delaware, and has purposely availed itself of the
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`rights and benefits of Delaware law and this Court. This Court has personal jurisdiction over Par
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`by virtue of, inter alia, these above-mentioned facts.
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`7.
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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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`8.
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`Plaintiff NPC holds approved New Drug Application (“NDA”) No. 22-
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`334 for AFINITOR® (everolimus) tablets for oral administration (2.5 mg, 5 mg, 7.5 mg and 10
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`mg dosage strengths), which contain the active ingredient everolimus. AFINITOR® tablets were
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`approved by the United States Food and Drug Administration (“FDA”) on March 30, 2009 (5 mg
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`and 10 mg dosage strengths), July 9, 2010 (2.5 mg dosage strength), and March 30, 2012 (7.5 mg
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`dosage strength). AFINITOR® tablets are indicated for the treatment of: postmenopausal women
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`with advanced hormone receptor-positive, HER2-negative breast cancer in combination with
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`exemestane after failure of treatment with letrozole or anastrozole; adults with progressive
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`neuroendocrine tumors of pancreatic origin that are unresectable, locally advanced or metastatic;
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`adults with advanced renal cell carcinoma after failure of treatment with sunitinib or sorafenib;
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`adults with renal angiomyolipoma and tuberous sclerosis complex, not requiring immediate
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`surgery; and pediatric and adult patients with tuberous sclerosis complex who have
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`subependymal giant cell astrocytoma that requires therapeutic intervention but cannot be
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`curatively resected. AFINITOR® (everolimus) tablets for oral administration (2.5 mg, 5 mg, 7.5
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`mg and 10 mg dosage strengths) are sold in the United States by Plaintiff NPC.
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`9.
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`Everolimus is known chemically as
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`(1R,9S,12S,15R,16E,18R,19R,21R,23S,24E,26E,28E,30S,32S,35R)-1,18-dihydroxy-12-{(1R)-
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`2-[(1S,3R,4R)-4-(2-hydroxyethoxy)-3-methoxycyclohexyl]-1-methylethyl}-19,30-dimethoxy-
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`15,17,21,23,29,35-hexamethyl-11,36-dioxa-4-aza-tricyclo[30.3.1.04,9]hexatriaconta-16,24,26,28-
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`tetraene-2,3,10,14,20-pentaone and also as 40-O-(2-hydroxyethyl)-rapamycin. The chemical
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`name “(1R,9S,12S,15R,16E,18R,19R,21R,23S,24E,26E,28E,30S,32S,35R)-1,18-dihydroxy-12-
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`{(1R)-2-[(1S,3R,4R)-4-(2-hydroxyethoxy)-3-methoxycyclohexyl]-1-methylethyl}-19,30-
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`dimethoxy-15,17,21,23,29,35-hexamethyl-11,36-dioxa-4-aza-tricyclo[30.3.1.04,9]hexatriaconta-
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`16,24,26,28-tetraene-2,3,10,14,20-pentaone” is equivalent to “40-O-(2-hydroxyethyl)-
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`rapamycin.”
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`10.
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`11.
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`Everolimus is a 40-O-substituted rapamycin.
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`Plaintiff Novartis AG is the owner of United States Letters Patent No.
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`5,665,772 (“the ‘772 patent”). The ‘772 patent was duly and legally issued on September 9,
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`1997.
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`12.
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`The ‘772 patent claims, inter alia, the compound which is 40-O-(2-
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`hydroxyethyl)-rapamycin and a pharmaceutical composition containing this compound. A true
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`copy of the ‘772 patent is attached as Exhibit A.
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`13.
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`Plaintiff Novartis AG is the owner of United States Letters Patent No.
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`7,297,703 (“the ‘703 patent”). The ‘703 patent was duly and legally issued on November 20,
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`2007.
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`14.
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`The ‘703 patent claims, inter alia, a solid mixture comprising a 40-O-
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`substituted rapamycin and an antioxidant present in a catalytic amount, and pharmaceutical
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`compositions comprising such solid mixture as active ingredient, admixed with one or more
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`pharmaceutically acceptable carriers or diluents. A true copy of the ‘703 patent is attached as
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`Exhibit B.
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`15.
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`Plaintiff Novartis AG is the owner of United States Letters Patent No.
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`7,741,338 (“the ‘338 patent”). The ‘338 patent was duly and legally issued on June 22, 2010.
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`16.
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`The ‘338 patent claims, inter alia, a solid mixture comprising 40-O-(2-
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`hydroxy)ethyl-rapamycin and 2,6-di-tert-butyl-methylphenol (BHT), and pharmaceutical
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`compositions comprising this solid mixture together with one or more pharmaceutically
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`acceptable diluents or carriers. A true copy of the ‘338 patent is attached as Exhibit C.
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`17.
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`On information and belief, Par submitted to the FDA an abbreviated new
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`drug application (“ANDA”) under the provisions of 21 U.S.C. § 355(j) seeking approval to
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`engage in the commercial manufacture, use, and sale of everolimus tablets (2.5 mg, 5 mg, and
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`7.5 mg dosage strengths) (“Par’s ANDA Products”) before the expiration of the ‘772, ‘703 and
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`‘338 patents.
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`18.
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`On information and belief, Par 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 ‘772 and ‘703 patent claims are invalid and/or will not be infringed. Par did not
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`allege that any of the ‘772 and/or ‘703 patent claims were unenforceable.
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`19.
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`Plaintiffs received written notification of Par’s ANDA and its
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`accompanying § 505(j)(2)(A)(vii)(IV) certification by a letter dated December 10, 2014 (“Notice
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`Letter”) informing Plaintiffs that Par had submitted to the FDA an ANDA under the provisions
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`of 21 U.S.C. § 355(j) seeking approval to engage in the commercial manufacture, use and sale of
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`2.5 mg, 5 mg, and 7.5 mg everolimus tablets.
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`Letter.
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`20.
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`21.
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`This action was commenced within 45 days of receipt of the Par 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 Par’s ANDA Products before
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`the expiration of the ‘772, ‘703 and ‘338 patents, Par has committed an act of infringement under
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`35 U.S.C. § 271(e)(2).
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`22.
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`On information and belief, when Par filed its ANDA, it was aware of the
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`‘772, ‘703 and ‘338 patents and that the filing of its ANDA with the request for its approval prior
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`to the expiration of the ‘772, ‘703 and ‘338 patents was an act of infringement of those patents.
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`23.
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`On information and belief, the commercial manufacture, use, offer for
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`sale, sale, and/or importation of Par’s ANDA Products will infringe one or more claims of the
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`‘772, ‘703 and ‘338 patents.
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`24.
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`On information and belief, Par’s ANDA Products, if approved, will
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`contain 40-O-(2-hydroxyethyl)-rapamycin.
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`25.
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`On information and belief, Par’s ANDA Products, if approved, will be
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`pharmaceutical compositions containing a therapeutically effective amount of 40-O-(2-
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`hydroxyethyl)-rapamycin and a pharmaceutically acceptable carrier.
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`26.
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`Par did not deny infringement of claims 1–3 and 7–10 of the ‘772 patent in
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`its Notice Letter.
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`27.
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`On information and belief, the commercial manufacture of Par’s ANDA
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`Products will involve direct infringement of the ‘772 patent. On information and belief, this will
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`occur at Par’s active behest, and with Par’s intent, knowledge, and encouragement.
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`28.
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`On information and belief, Par’s ANDA Products, if approved, will be
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`pharmaceutical compositions comprising an active ingredient admixed with one or more
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`pharmaceutically acceptable carriers or diluents. On information and belief, said active
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`ingredient will be a solid mixture comprising a 40-O-substituted rapamycin and an antioxidant
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`present in a catalytic amount.
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`29.
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`On information and belief, the commercial manufacture of Par’s ANDA
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`Products will involve direct infringement of the ‘703 patent. On information and belief, this will
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`occur at Par’s active behest, and with Par’s intent, knowledge, and encouragement.
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`30.
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`On information and belief, Par’s ANDA Products, if approved, will
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`comprise a solid mixture comprising 40-O-(2-hydroxy)ethyl-rapamycin and 2,6-di-tert-butyl-
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`methylphenol (BHT).
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`31.
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`On information and belief, Par’s ANDA Products, if approved, will be
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`pharmaceutical compositions comprising a solid mixture comprising 40-O-(2-hydroxy)ethyl-
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`rapamycin and 2,6-di-tert-butyl-methylphenol (BHT) together with one or more
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`pharmaceutically acceptable diluents or carriers.
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`32.
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`On information and belief, the commercial manufacture of Par’s ANDA
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`Products will involve direct infringement of the ‘338 patent. On information and belief, this will
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`occur at Par’s active behest, and with Par’s intent, knowledge, and encouragement.
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`33.
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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 ANDA relating to
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`Par’s ANDA Products be a date that is no earlier than March 9, 2020, the expiration of the ‘772
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`patent’s pediatric exclusivity, and June 6, 2020, the expiration of the ‘703 and ‘338 patents’
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`pediatric exclusivity, and an award of damages for any commercial sale or use of Par’s ANDA
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`Products and any act committed by Par with respect to the subject matter claimed in the ‘772,
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`‘703 and ‘338 patents, which act is not within the limited exclusions of 35 U.S.C. § 271(e)(1).
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`34.
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`On information and belief, Par has taken and continues to take active steps
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`towards the commercial manufacture, use, offer for sale, sale, and/or importation of Par’s ANDA
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`Products, including seeking approval of those products under Par’s ANDA.
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`35.
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`There is a substantial and immediate controversy between Plaintiffs and
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`Par concerning the ‘772, ‘703 and ‘338 patents. Plaintiffs are entitled to declaratory judgment
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`under 28 U.S.C. §§ 2201 and 2202 that Par will infringe and/or induce infringement of one or
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`more claims of the ‘772, ‘703 and ‘338 patents.
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`WHEREFORE, Plaintiffs respectfully request the following relief:
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`PRAYER FOR RELIEF
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`A.
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`Judgment that Par has directly infringed and/or induced infringement of
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`one or more claims of the ‘772, ‘703 and ‘338 patents by filing an ANDA relating to Par’s
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`everolimus tablets (2.5 mg, 5 mg, and 7.5 mg dosage strengths);
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`B.
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`A permanent injunction restraining and enjoining Par 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 Par’s everolimus tablets (2.5 mg, 5 mg, and 7.5 mg dosage strengths),
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`as claimed in the ‘772, ‘703 and ‘338 patents;
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`C.
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`An order that the effective date of any approval of the ANDA relating to
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`Par’s everolimus tablets (2.5 mg, 5 mg, and 7.5 mg dosage strengths), be a date that is not earlier
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`than the expiration of the right of exclusivity under the ‘772, ‘703 and ‘338 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 Par’s everolimus tablets (2.5 mg, 5 mg, and 7.5 mg dosage strengths)
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`will infringe one or more claims of the ‘772, ‘703 and ‘338 patents and/or that Par will induce
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`infringement of one or more claims of the ‘772, ‘703 and ‘338 patents;
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`E.
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`Damages from Par for the infringement and inducement of infringement of
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`the ‘772, ‘703 and ‘338 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: January 23, 2015
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`McCARTER & ENGLISH, LLP
`
`/s/ Daniel M. Silver
`Michael P. Kelly (#2295)
`Daniel M. Silver (#4758)
`Benjamin A. Smyth (#5528)
`Renaissance Centre
`405 N. King Street, 8th Floor
`Wilmington, Delaware 19801
`(302) 984-6300
`mkelly@mccarter.com
`dsilver@mccarter.com
`bsmyth@mccarter.com
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`Attorneys for Plaintiffs
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`Of Counsel:
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`Nicholas N. Kallas
`Charlotte Jacobsen
`Christina Schwarz
`Laura K. Fishwick
`FITZPATRICK, CELLA, HARPER & SCINTO
`1290 Avenue of the Americas
`New York, New York 10104-3800
`(212) 218-2100
`nkallas@fchs.com
`cjacobsen@fchs.com
`cschwarz@fchs.com
`lfishwick@fchs.com
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