Case 1:14-cv-01289-RGA Document 1 Filed 10/10/14 Page 1 of 10 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 manufacturing,
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`marketing, and selling pharmaceutical drug products, including generic drug products. On
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`information and belief, Par directly or through its affiliates and agents markets and sells drug
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`products throughout the United States and in this judicial district, is incorporated in Delaware,
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`has a registered agent for service in Delaware, and has purposely availed itself of the rights and
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`benefits of Delaware law and this Court. This Court has personal jurisdiction over Par for this
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`reason and the additional reasons set forth below, and for other reasons that will be presented to
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`the Court if jurisdiction is challenged.
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`7.
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`This Court has personal jurisdiction over Par by virtue of, inter alia, the
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`above-mentioned facts.
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`8.
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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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`9.
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`Plaintiff NPC holds approved New Drug Application (“NDA”) No. 21-
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`560 for ZORTRESS® (everolimus) tablets (0.25 mg, 0.5 mg, and 0.75 mg dosage strengths),
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`which contain the active ingredient everolimus. ZORTRESS® tablets were approved by the
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`United States Food and Drug Administration (“FDA”) on April 20, 2010. ZORTRESS® tablets
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`are indicated for the prophylaxis of organ rejection in adult patients at low-moderate
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`immunologic risk receiving a kidney transplant, and for the prophylaxis of allograft rejection in
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`adult patients receiving a liver transplant. ZORTRESS® tablets (0.25 mg, 0.5 mg, and 0.75 mg
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`dosage strengths) are sold in the United States by Plaintiff NPC.
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`10.
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`Everolimus is known chemically as (1R, 9S, 12S, 15R, 16E, 18R, 19R,
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`21R, 23S, 24E, 26E, 28E, 30S, 32S, 35R)-1, 18-dihydroxy-12-{(1R)-2-[(1S,3R,4R)-4-(2-
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`hydroxyethoxy)-3-methoxycyclohexyl]-1-methylethyl}-19,30-dimethoxy-15, 17, 21, 23, 29, 35-
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`hexamethyl-11, 36-dioxa-4-aza-tricyclo[30.3.1.04,9] hexatriaconta-16,24,26,28-tetraene-2,
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`3,10,14,20-pentaone and also as 40-O-(2-hydroxyethyl)-rapamycin. The chemical name “(1R,
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`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]
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`hexatriaconta-16,24,26,28-tetraene-2, 3,10,14,20-pentaone” is equivalent to “40-O-(2-
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`hydroxyethyl)-rapamycin.”
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`11.
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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, a pharmaceutical composition containing this compound, and methods
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`of inducing an immunosuppressant effect and preventing allograft rejection using this compound.
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`A true 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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`6,004,973 (“the ‘973 patent”). The ‘973 patent was duly and legally issued on December 21,
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`1999.
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`14.
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`The ‘973 patent claims, inter alia, pharmaceutical compositions
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`comprising: a solid dispersion in the form of a co-precipitate, said solid dispersion comprising
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`40-O-(2-hydroxy)ethyl rapamycin and a carrier medium, and a method of treating organ allo-
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`transplant rejection using said pharmaceutical compositions. A true copy of the ‘973 patent is
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`attached as 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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`6,455,518 (“the ‘518 patent”). The ‘518 patent was duly and legally issued on September 24,
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`2002.
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`16.
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`The ‘518 patent claims, inter alia, methods of treating or preventing a
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`transplant rejection and methods of treating or preventing chronic rejection of a kidney transplant
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`in a subject at risk for such rejection, comprising co-administering synergistically effective
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`amounts of an IL-2 transcription inhibitor and 40-O-(2-hydroxyethyl)-rapamycin. A true copy of
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`the ‘518 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, 0.25 mg, 0.5 mg, and
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`0.75 mg dosage strengths (“Par’s ANDA Products”) before the expiration of the ‘772, ‘973, and
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`‘518 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, ‘973, and ‘518 patent claims are invalid and/or will not be infringed. Par
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`did not allege that any of the ‘772, ‘973, and/or ‘518 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 August 29, 2014 (“Notice
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`Letter”).
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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, ‘973, and ‘518 patents, Par has committed an act of infringement
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`under 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, ‘973, and ‘518 patents and that the filing of its ANDA with the request for its approval
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`prior to the expiration of the ‘772, ‘973, and ‘518 patents was an act of infringement of those
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`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 and/or induce infringement
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`of one or more claims of the ‘772, ‘973, and ‘518 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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`On information and belief, Par’s ANDA Products, if approved, will
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`contain instructions for administering an immunosuppressant effective amount of 40-O-(2-
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`hydroxyethyl)-rapamycin to a subject in need of immunosuppression, which will induce an
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`immunosuppressant effect in said subject.
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`27.
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`On information and belief, Par’s ANDA Products, if approved, will
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`contain instructions for administering an amount of 40-O-(2-hydroxyethyl)-rapamycin effective
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`to prevent allograft rejection to a subject in need of such treatment, which will prevent allograft
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`rejection in said subject.
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`28.
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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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`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 ‘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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`30.
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`On information and belief, Par’s ANDA Products, if approved, will be
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`administered to induce an immunosuppressant effect in a subject in need of immunosuppression,
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`which administration will constitute direct infringement of the ‘772 patent. On information and
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`belief, Par will actively induce, encourage, and abet this infringement with knowledge that it is in
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`contravention of the rights under the ‘772 patent.
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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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`administered to prevent allograft rejection in a subject in need of such treatment, which
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`administration will constitute direct infringement of the ‘772 patent. On information and belief,
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`Par will actively induce, encourage, and abet this infringement with knowledge that it is in
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`contravention of the rights under the ‘772 patent.
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`32.
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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 dispersion in the form of a co-precipitate. On
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`information and belief, said solid dispersion will comprise 40-O-(2-hydroxyethyl)-rapamycin
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`and a carrier medium. On information and belief, said carrier medium will contain
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`hydroxypropylmethylcellulose (a water-soluble polymer). On information and belief, said
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`pharmaceutical composition will be free of surfactants. On information and belief, said
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`pharmaceutical composition will contain an antioxidant.
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`33.
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`On information and belief, Par’s ANDA Products, if approved, will
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`contain instructions for orally administering an effective amount of a pharmaceutical
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`composition, in the form of a co-precipitate comprising 40-O-(2-hydroxyethyl)-rapamycin and a
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`carrier medium, to a subject at risk for organ allo-transplant rejection, which will treat such
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`rejection.
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`34.
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`Par did not deny infringement of claims 1-10 and 13-15 of the ‘973 patent
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`in its Notice Letter.
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`35.
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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 ‘973 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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`36.
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`On information and belief, Par’s ANDA Products, if approved, will be
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`orally administered to treat organ allo-transplant rejection, which administration will constitute
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`direct infringement of the ‘973 patent. On information and belief, Par will actively induce,
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`encourage, and abet this infringement with knowledge that it is in contravention of the rights
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`under the ‘973 patent.
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`37.
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`On information and belief, Par’s ANDA products, if approved, will
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`contain instructions for co-administering synergistically effective amounts of an IL-2
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`transcription inhibitor and 40-O-(2-hydroxyethyl)-rapamycin to a subject at risk for transplant
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`rejection or chronic rejection of a kidney transplant, which will treat or prevent such rejection.
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`38.
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`On information and belief, Par’s ANDA Products, if approved, will be co-
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`administered with an IL-2 transcription inhibitor in synergistically effective amounts to a subject
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`for the treatment or prevention of a transplant rejection and for the treatment or prevention of
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`chronic rejection of a kidney transplant, in a subject at risk for such rejection, which co-
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`administration will constitute direct infringement of the ‘518 patent. On information and belief,
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`this will occur at Par’s active behest, and with Par’s intent, knowledge, and encouragement. On
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`information and belief, Par will actively induce, encourage, and abet this infringement with
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`knowledge that it is in contravention of the rights under the ‘518 patent.
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`39.
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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 an award of damages for any commercial sale or use of Par’s
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`ANDA Products and any act committed by Par with respect to the subject matter claimed in the
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`‘772, ‘973, ‘and ‘518 patents, which act is not within the limited exclusions of 35 U.S.C. §
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`271(e)(1).
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`40.
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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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`41.
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`There is a substantial and immediate controversy between Plaintiffs and
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`Par concerning the ‘772, ‘973, and ‘518 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, ‘973, and ‘518 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, ‘973, and ‘518 patents by filing an ANDA relating to Par’s
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`everolimus tablets, 0.25 mg, 0.5 mg, and 0.75 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, 0.25 mg, 0.5 mg, and 0.75 mg dosage
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`strengths, as claimed in the ‘772, ‘973, and ‘518 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, 0.25 mg, 0.5 mg, and 0.75 mg dosage strengths, be a date that is not
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`earlier than the expiration of the right of exclusivity under the ‘772, ‘973, and ‘518 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, 0.25 mg, 0.5 mg, and 0.75 mg dosage
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`strengths, will infringe one or more claims of the ‘772, ‘973, and ‘518 patents and/or that Par
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`will induce infringement of one or more claims of the ‘772, ‘973, and ‘518 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, ‘973, and ‘518 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: October 10, 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
`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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