Case 1:15-cv-00475-RGA Document 7 Filed 06/19/15 Page 1 of 9 PageID #: 38
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
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`C.A. No. 1:15-cv-00475-RGA
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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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`FIRST AMENDED 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
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`women with advanced hormone receptor-positive, HER2-negative breast cancer in combination
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`with 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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`Plaintiff Novartis AG is the owner of United States Letters Patent No.
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`9,006,224 (“the ’224 Patent”). The ’224 Patent was duly and legally issued on April 14, 2015.
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`11.
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`The ’224 Patent claims, inter alia, a method for treating pancreatic
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`neuroendocrine tumors, comprising administering to a human subject in need thereof a
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`therapeutically effective amount of 40-O-(2-hydroxyethyl)-rapamycin as a monotherapy and
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`wherein the tumors are advanced tumors after failure of cytotoxic chemotherapy. A true copy of
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`the ‘224 Patent is attached as Exhibit A.
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`12.
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`Plaintiffs notified Par of the issuance of the ’224 Patent on April 14, 2015,
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`the day the patent issued.
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`13.
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`On information and belief, Par has submitted to the FDA and maintained
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`an abbreviated new drug application (“ANDA”) under the provisions of 21 U.S.C. § 355(j)
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`seeking approval to engage in the commercial manufacture, use, and sale of everolimus tablets
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`(2.5 mg, 5 mg, 7.5 mg, and 10 mg dosage strengths) (the “ANDA Products”) before the
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`expiration of the ’224 Patent.
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`14.
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`On information and belief, Par has amended its ANDA to include a
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`certification under 21 U.S.C. § 355(j)(2)(A)(vii)(IV) with respect to the ’224 Patent.
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`15.
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`Plaintiffs received written notification of the amendment to Par’s ANDA
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`to include the § 505(j)(2)(A)(vii)(IV) certification by a letter dated June 12, 2015 (“Notice
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`Letter”).
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`16.
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`This action was commenced prior to the expiration of the 45-day period
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`from receipt of the Par Notice Letter.
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`17.
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`By filing, amending and maintaining its ANDA under 21 U.S.C. § 355(j)
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`for the purpose of obtaining approval to engage in the commercial manufacture, use, or sale of
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`Par’s ANDA Products before the expiration of the ’224 Patent, Par has committed an act of
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`infringement under 35 U.S.C. § 271(e)(2).
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`18.
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`On information and belief, when Par amended and/or maintained its
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`ANDA, it was aware of the ’224 Patent and that the filing, amending and/or maintaining of its
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`ANDA with the request for its approval prior to the expiration of the ’224 Patent was an act of
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`infringement of that patent.
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`19.
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`On information and belief, the commercial manufacture, offer for sale,
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`sale or use of Par’s ANDA Products will infringe one or more claims of the ’224 Patent.
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`20.
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`On information and belief, Par’s ANDA Products, if approved, will be
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`administered for treating pancreatic neuroendocrine tumors to a human subject in need thereof in
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`a therapeutically effective amount as a monotherapy and wherein the tumors are advanced
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`tumors after failure of cytotoxic chemotherapy, which administration will constitute direct
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`infringement of the ’224 Patent. On information and belief, if its ANDA Products are approved,
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`Par will actively induce, encourage, and abet this infringement with knowledge of the ’224
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`Patent and that its acts will induce infringement of the ’224 Patent.
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`21.
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`On information and belief, Par’s ANDA Products, if approved, will
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`contain instructions for administering 40-O-(2-hydroxyethyl)-rapamycin for treating pancreatic
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`neuroendocrine tumors to a human subject in need thereof in a therapeutically effective amount
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`as a monotherapy and wherein the tumors are advanced tumors after failure of cytotoxic
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`chemotherapy.
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`22.
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`On information and belief, if its ANDA is approved, Par will actively
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`induce, encourage, and abet infringement of the ’224 Patent, and will do so with knowledge of
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`the ’224 Patent and with knowledge that its acts will induce infringement of the ’224 Patent.
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`23.
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`On information and belief, if its ANDA is approved, Par will
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`commercially manufacture, offer for sale, and sell its ANDA Products for use in a method for
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`treating pancreatic neuroendocrine tumors, comprising administering to a human subject in need
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`thereof a therapeutically effective amount of 40-O-(2-hydroxyethyl)-rapamycin as a
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`monotherapy and wherein the tumors are advanced tumors after failure of cytotoxic
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`chemotherapy.
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`24.
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`On information and belief, if its ANDA is approved, Par’s ANDA
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`Products will be specifically labeled for administering 40-O-(2-hydroxyethyl)-rapamycin for
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`treating pancreatic neuroendocrine tumors to a human subject in need thereof in a therapeutically
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`effective amount as a monotherapy and wherein the tumors are advanced tumors after failure of
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`cytotoxic chemotherapy.
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`25.
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`On information and belief, there are no substantial noninfringing uses of
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`Par’s ANDA Products.
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`26.
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`On information and belief, if approved, Par’s ANDA Products will
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`constitute a material part of a method for treating pancreatic neuroendocrine tumors, comprising
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`administering to a human subject in need thereof a therapeutically effective amount of 40-O-(2-
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`hydroxyethyl)-rapamycin as a monotherapy and wherein the tumors are advanced tumors after
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`failure of cytotoxic chemotherapy.
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`27.
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`On information and belief, if its ANDA is approved, Par will
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`contributorily infringe the ’224 Patent, and will do so with knowledge of the ’224 Patent and that
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`its ANDA Products are especially made or especially adapted for use in infringing the ’224
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`Patent.
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`28.
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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 July 1, 2028, the expiration of the ’224
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`Patent, and an award of damages for any commercial sale or use of Par’s ANDA Products and
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`any act committed by Par with respect to the subject matter claimed in the ’224 Patent, which act
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`is not within the limited exclusions of 35 U.S.C. § 271(e)(1).
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`29.
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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 to market those products under Par’s ANDA prior to the
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`expiration of the ’224 Patent.
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`30.
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`There is a substantial and immediate controversy between Plaintiffs and
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`Par concerning the ’224 Patent. Plaintiffs are entitled to declaratory judgment under 28 U.S.C.
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`§§ 2201 and 2202 that Par will induce infringement of and/or contributorily infringe one or more
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`claims of the ’224 Patent.
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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 one or more claims of the ’224
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`Patent by filing, amending and/or maintaining an ANDA relating to Par’s everolimus tablets (2.5
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`mg, 5 mg, 7.5 mg, and 10 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, 7.5 mg, and 10 mg dosage
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`strengths), as claimed in the ’224 Patent;
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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, 7.5 mg, and 10 mg dosage strengths), be a date that is not
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`earlier than the expiration of the right of exclusivity under the ’224 Patent;
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`D.
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`Declaratory judgment that Par will induce infringement and/or
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`contributorily infringe of one or more claims of the ’224 Patent by commercially manufacturing,
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`offering for sale and/or selling its everolimus tablets (2.5 mg, 5 mg, 7.5 mg, and 10 mg dosage
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`strengths);
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`E.
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`Damages from Par for the infringement and/or inducement of
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`infringement and/or contributory infringement of the ’224 Patent;
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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: June 19, 2015
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`McCARTER & ENGLISH, LLP
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`/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
`Christopher E. Loh
`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
`cloh@fchs.com
`cjacobsen@fchs.com
`cschwarz@fchs.com
`lfishwick@fchs.com
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