Case 1:16-cv-00431-RGA Document 1 Filed 06/10/16 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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`NOVARTIS PHARMACEUTICALS
`CORPORATION and NOVARTIS AG,
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`Plaintiffs,
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`v.
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`BRECKENRIDGE PHARMACEUTICAL,
`INC.,
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`Defendant.
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`C.A. No. _____________
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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 Breckenridge Pharmaceutical, Inc. allege as
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`follows:
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`1.
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`2.
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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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`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 Breckenridge Pharmaceutical, Inc.
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`(“Breckenridge”) is a corporation organized and existing under the laws of the State of Florida,
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`having a place of business at 6111 Broken Sound Parkway, NW, Suite 170, Boca Raton, Florida
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`33487. Upon information and belief, defendant Breckenridge manufactures numerous generic
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`drugs for sale and use throughout the United States, including in this judicial 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, Breckenridge is in the business of
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`manufacturing, marketing, and selling pharmaceutical drug products, including generic drug
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`products. On information and belief, Breckenridge directly or through its affiliates and agents
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`markets and sells drug products throughout the United States and in this judicial district, and has
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`purposely availed itself of the rights and benefits of Delaware law and this Court. This Court has
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`personal jurisdiction over Breckenridge for this reason and the additional reasons set forth below,
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`and for other reasons that will be presented to the Court if jurisdiction is challenged.
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`7.
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`This Court has personal jurisdiction over Breckenridge because, as
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`explained further below, Breckenridge has taken the costly, significant step of applying, through
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`an Abbreviated New Drug Application (“ANDA”) to the United States Food and Drug
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`Administration (“FDA”), for approval under the Hatch-Waxman Act to engage in future
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`infringing activities, including the marketing and sale of the accused infringing everolimus
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`tablets, 10 mg dosage strength described herein, that will be purposefully directed at Delaware.
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`Breckenridge’s ANDA filing constitutes a formal act that reliably indicates its plans to engage in
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`marketing of the accused infringing product in Delaware. This act is sufficient to confer specific
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`jurisdiction over Breckenridge in Delaware. See Acorda Therapeutics Inc. v. Mylan
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`Pharmaceuticals Inc., 817 F.3d 755 (Fed. Cir. 2016).
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`8.
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`This Court has personal jurisdiction over Breckenridge because
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`Breckenridge has affirmatively availed itself of the jurisdiction of this Court by filing a lawsuit
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`and counterclaims in this district, and has previously been sued in this district and has not
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`challenged personal jurisdiction. See, e.g., Pamlab, LLC, et al. v. Acella Pharmaceuticals, LLC,
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`1:12-cv-01403 (D. Del.) (plaintiff); Pfizer Inc., et al. v. Breckenridge Pharmaceutical, Inc., et
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`al., 1:12-cv-00810 (consolidated with 1:12-cv-00808) (D. Del.) (defendant and counterclaimant);
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`Par Pharmaceutical, Inc., et al. v. Breckenridge Pharmaceutical, Inc., 1:13-cv-01114 (D. Del.)
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`(defendant and counterclaimant); UCB, Inc., et al. v. Breckenridge Pharmaceutical, Inc., et al.,
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`1:13-cv-01211 (D. Del.) (defendant and counterclaimant); Cephalon, Inc. v. Breckenridge
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`Pharmaceutical, Inc., et al., 1:14-cv-00671 (D. Del.) (defendant and counterclaimant);
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`Cephalon, Inc., et al. v. Breckenridge Pharmaceutical, Inc., et al., 1:11-cv-01070 (D. Del.)
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`(defendant); and Novartis Pharmaceuticals Corporation v. Breckenridge Pharmaceutical, Inc.,
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`1:14-cv-01043 (D. Del.) (defendant and counterclaimant).
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`9.
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`This Court has personal jurisdiction over Breckenridge by virtue of, inter
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`alia, the fact that Breckenridge has availed itself of the rights and benefits of the laws of
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`Delaware by engaging in systematic and continuous contacts with Delaware.
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`10.
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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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`11.
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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 FDA on March 30, 2009 (5 mg and 10 mg dosage strengths), July 9, 2010 (2.5
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`mg dosage strength), and March 30, 2012 (7.5 mg dosage strength). AFINITOR® tablets are
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`indicated for the treatment of postmenopausal women with advanced hormone receptor-positive,
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`HER2-negative breast cancer in combination with exemestane after failure of treatment with
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`letrozole or anastrozole; adults with progressive neuroendocrine tumors of pancreatic origin that
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`are unresectable, locally advanced or metastatic; adults with progressive, well-differentiated,
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`non-functional, neuroendocrine tumors of gastrointestinal or lung origin with unresectable,
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`locally advanced or metastatic disease; adults with advanced renal cell carcinoma after failure of
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`treatment with sunitinib or sorafenib; adults with renal angiomyolipoma and tuberous sclerosis
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`complex, not requiring immediate surgery; and pediatric and adult patients with tuberous
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`sclerosis complex who have subependymal giant cell astrocytoma that requires therapeutic
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`intervention but cannot be curatively resected. AFINITOR® (everolimus) tablets for oral
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`administration (2.5 mg, 5 mg, 7.5 mg and 10 mg dosage strengths) are sold in the United States
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`by Plaintiff NPC.
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`12.
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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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`13.
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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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`14.
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`The ‘772 patent claims, inter alia, the compound everolimus and a
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`pharmaceutical composition containing a therapeutically effective amount everolimus and a
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`pharmaceutically acceptable carrier. A true copy of the ‘772 patent is attached as Exhibit A.
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`15.
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`Plaintiff NPC is the owner of United States Letters Patent No. 8,410,131
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`(“the ‘131 patent”). The ‘131 patent was duly and legally issued on April 2, 2013.
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`16.
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`The ‘131 patent claims, inter alia, a method for inhibiting growth of solid
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`excretory system tumors in a subject, said method consisting of administering to said subject a
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`therapeutically effective amount of everolimus. A true copy of the ‘131 patent is attached as
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`Exhibit B.
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`17.
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`Plaintiff NPC is the owner of United States Letters Patent No. 8,778,962
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`(“the ‘962 patent”). The ‘962 patent was duly and legally issued on July 15, 2014.
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`18.
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`The ‘962 patent claims, inter alia, a method for inhibiting growth of non-
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`malignant solid tumors of the brain in a subject, said method consisting of administering to said
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`subject a therapeutically effective amount of everolimus. A true copy of the ‘962 patent is
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`attached as Exhibit C.
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`19.
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`On information and belief, Breckenridge 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 everolimus tablets, 10 mg
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`dosage strength (“Breckenridge’s ANDA Product”) before the expiration of the ‘772, ‘131 and
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`‘962 patents.
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`20.
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`On information and belief, Breckenridge made and included in its ANDA
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`a 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, ‘131 and ‘962 patents claim are invalid and/or will not be infringed. On
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`information and belief, Breckenridge has not provided a detailed statement of the legal and
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`factual bases for any allegation that any claim of the ‘772, ‘131 or ‘962 patents is unenforceable.
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`21.
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`Plaintiffs received written notification of Breckenridge’s ANDA and its
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`accompanying 21 U.S.C. § 355(j)(2)(A)(vii)(IV) certification by a letter dated April 28, 2016
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`(“Notice Letter”).
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`Notice Letter.
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`22.
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`23.
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`This action was commenced within 45 days of receipt of the Breckenridge
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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 Breckenridge’s ANDA
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`Product before the expiration of the ‘772, ‘131 and ‘962 patents, Breckenridge has committed an
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`act of infringement under 35 U.S.C. § 271(e)(2).
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`24.
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`On information and belief, when Breckenridge filed its ANDA, it was
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`aware of the ‘772, ‘131 and ‘962 patents and that the filing of its ANDA with the request for its
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`approval prior to the expiration of the ‘772, ‘131 and ‘962 patents was an act of infringement of
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`those patents.
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`25.
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`On information and belief, the commercial manufacture, use, offer for
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`sale, sale, and/or importation of Breckenridge’s ANDA Product will infringe, induce
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`infringement of and/or contributorily infringe one or more claims of the ‘772, ‘131 and ‘962
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`patents.
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`26.
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`On information and belief, Breckenridge’s ANDA Product, if approved,
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`will contain everolimus and be a pharmaceutical composition containing a therapeutically
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`effective amount everolimus and a pharmaceutically acceptable carrier. On information and
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`belief, the commercial manufacture, use, offer for sale, sale and/or importation of Breckenridge’s
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`ANDA Product will directly infringe the ‘772 patent.
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`27.
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`On information and belief, Breckenridge’s ANDA Product, if approved,
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`will contain instructions for administering a therapeutically effective amount of everolimus to
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`inhibit growth of solid excretory system tumors in a subject, which administration will constitute
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`direct infringement of the ‘131 patent. On information and belief, if Breckenridge’s ANDA
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`Product is approved, Breckenridge will actively induce, encourage, and abet this infringement
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`with knowledge of the ‘131 patent, and that its acts will induce infringement of the ‘131 patent.
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`28.
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`On information and belief, if Breckenridge’s ANDA Product is approved,
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`Breckenridge will commercially manufacture, offer for sale, sell, and/or import that product,
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`which product will be specifically labeled for use in a method for inhibiting growth of solid
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`excretory system tumors in a subject, said method consisting of administering to said subject a
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`therapeutically effective amount of everolimus. On information and belief, if Breckenridge’s
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`ANDA Product is approved, that product will constitute a material part of a method for inhibiting
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`growth of inhibiting growth of solid excretory system tumors, said method consisting of
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`administering to said subject a therapeutically effective amount of everolimus. On information
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`and belief, if Breckenridge’s ANDA Product is approved, Breckenridge will contributorily
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`infringe the ‘131 patent with knowledge of the ‘131 patent, and that its ANDA Product is
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`especially made or especially adapted for use in infringing the ‘131 patent and is not suitable for
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`a substantial noninfringing use.
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`29.
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`On information and belief, Breckenridge’s ANDA Product, if approved,
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`will contain instructions for administering a therapeutically effective amount of everolimus to
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`inhibit growth of non-malignant solid tumors of the brain in a subject, which administration will
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`constitute direct infringement of the ‘962 patent. On information and belief, if Breckendrige’s
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`ANDA Product is approved, Breckenridge will actively induce, encourage, and abet this
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`infringement with knowledge of the ‘962 patent, and that its acts will induce infringement of the
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`‘962 patent.
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`30.
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`On information and belief, if Breckenridge’s ANDA Product is approved,
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`Breckenridge will commercially manufacture, offer for sale, sell, and/or import that product,
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`which product will be specifically labeled for use in a method for inhibiting growth of non-
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`malignant solid tumors of the brain in a subject, said method consisting of administering to said
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`subject a therapeutically effective amount of everolimus. On information and belief, if
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`Breckenridge’s ANDA Product is approved, that product will constitute a material part of a
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`method for inhibiting growth of non-malignant solid tumors of the brain in a subject, said
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`method consisting of administering to said subject a therapeutically effective amount of
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`everolimus. On information and belief, if Breckenridge’s ANDA Product is approved,
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`Breckenridge will contributorily infringe the ‘962 patent, and will do so with knowledge of the
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`‘962 patent, and that its ANDA Product is especially made or especially adapted for use in
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`infringing the ‘962 patent and is not suitable for a substantial noninfringing use.
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`31.
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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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`Breckenridge’s ANDA Product be a date that is no earlier than March 9, 2020, the expiration of
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`the ‘772 patent’s pediatric exclusivity, May 1, 2026, the expiration date of the ‘131 patent’s
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`pediatric exclusivity, and August 18, 2022, the expiration date of the ‘962 patent’s pediatric
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`exclusivity, and an award of damages for any commercial sale or use of Breckenridge’s ANDA
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`Product and any act committed by Breckenridge with respect to the subject matter claimed in the
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`‘772, ’131 and ‘962 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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`32.
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`On information and belief, Breckenridge has taken and continues to take
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`active steps towards the commercial manufacture, use, offer for sale, sale, and/or importation of
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`its ANDA Product, including seeking approval of the product under Breckenridge’s ANDA.
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`33.
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`There is a substantial and immediate controversy between Plaintiffs and
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`Breckenridge concerning the ‘772, ‘131 and ‘962 patents. Plaintiffs are entitled to declaratory
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`judgment under 28 U.S.C. §§ 2201 and 2202 that Breckenridge will infringe, induce
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`infringement and/or contributorily infringe of one or more claims of the ‘772, ‘131 and ‘962
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`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 Breckenridge has directly infringed, induced infringement
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`of and/or contributorily infringed one or more claims of the ‘772, ‘131 and ‘962 patents by filing
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`an ANDA for Breckenridge’s everolimus tablets, 10 mg dosage strength;
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`B.
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`A permanent injunction restraining and enjoining Breckenridge and its
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`officers, agents, attorneys, and employees, and those acting in privity or concert with it, from
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`engaging in the commercial manufacture, use, offer to sell, or sale within the United States, or
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`importation into the United States, of Breckenridge’s everolimus tablet, 10 mg dosage strength,
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`as claimed in the ‘772, ‘131 and ‘962 patents;
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`C.
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`An order that the effective date of any approval of the ANDA for
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`Breckenridge’s everolimus tablets, 10 mg dosage strength, be a date that is not earlier than the
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`expiration of the right of exclusivity under the ‘772, ‘131 and ‘962 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 Breckenridge’s everolimus tablets, 10 mg dosage strength, will
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`infringe, induce infringement of and/or contributorily infringe one or more claims of the ‘772,
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`‘131 and ‘962 patents;
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`E.
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`Damages from Breckenridge for the infringement, inducement of
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`infringement and/or contributory infringement of the ‘772, ‘131 and ‘962 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: June 10, 2016
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`/s/ Daniel M. Silver
`Daniel M. Silver (#4758)
`Benjamin A. Smyth (#5528)
`McCARTER & ENGLISH, LLP
`Renaissance Centre
`405 N. King Street, 8th Floor
`Wilmington, Delaware 19801
`(302) 984-6300
`dsilver@mccarter.com
`bsmyth@mccarter.com
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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, NY 10104-3800
`(212) 218-2100
`nkallas@fchs.com
`cloh@fchs.com
`cjacobsen@fchs.com
`cschwarz@fchs.com
`lfishwick@fchs.com
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`Attorneys for Plaintiffs
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