Case 1:17-cv-00389-RGA Document 1 Filed 04/07/17 Page 1 of 10 PageID #: 1
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`NOVARTIS PHARMACEUTICALS
`CORPORATION and NOVARTIS AG,
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`Plaintiffs,
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`v.
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`MYLAN PHARMACEUTICALS INC.
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`Defendant.
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`C.A. No. _____________
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
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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 Mylan Pharmaceuticals 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 One Health Plaza, 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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`ME1 24559871v.1
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`NOVARTIS PHARMACEUTICALS
`CORPORATION and NOVARTIS AG,
`
`
`Plaintiffs,
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`v.
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`MYLAN PHARMACEUTICALS INC.
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`
`
`Defendant.
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`
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`C.A. No. _____________
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`
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
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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 Mylan Pharmaceuticals 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 One Health Plaza, 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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`ME1 24559871v.1
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`Case 1:17-cv-00389-RGA Document 1 Filed 04/07/17 Page 2 of 10 PageID #: 2
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`4.
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`On information and belief, defendant Mylan Pharmaceuticals Inc.
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`(“Mylan”) is a corporation organized and existing under the laws of the State of West Virginia,
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`having a place of business at 781 Chestnut Ridge Road, Morgantown, West Virginia 26505.
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`Upon information and belief, defendant Mylan directly or indirectly develops, manufactures,
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`markets and distributes numerous generic drugs for sale and use throughout the United States,
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`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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`This Court has jurisdiction over Mylan because, inter alia, on information
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`and belief, Mylan is registered to do business in Delaware as a foreign corporation, with filing
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`number 4809319. Mylan has a designated agent in Delaware for the receipt of service of process
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`as Corporation Service Company, 2711 Centerville Road, Suite 400, Wilmington, Delaware
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`19808. Mylan holds a Pharmacy Wholesale License from the State of Delaware under License
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`No. A4-0001719. Mylan holds a Distributor/Manufacturer License for Controlled Substances
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`from the State of Delaware under License No. DM-0007571. Mylan directly or indirectly is in
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`the business of developing, manufacturing, marketing, importing, offering to sell and selling
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`pharmaceutical drug products, including generic drug products, throughout the United States,
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`including this judicial district. Delaware would be a destination of Mylan’s ANDA Products
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`upon approval and marketing of Mylan’s ANDA Products involved in this action. Mylan’s filing
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`of its ANDA involved in this action constitutes a formal act that reliably indicates its plans to
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`engage in marketing of the accused infringing ANDA products in Delaware. This act is
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`Case 1:17-cv-00389-RGA Document 1 Filed 04/07/17 Page 3 of 10 PageID #: 3
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`sufficient to confer specific jurisdiction over Mylan in Delaware. See Acorda Therapeutics Inc.
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`v. Mylan Pharms. Inc., 817 F.3d 755 (Fed. Cir. 2016).
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`7.
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`On information and belief, Mylan has purposely availed itself of the rights
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`and benefits of this Court without objecting on the basis of lack of personal jurisdiction when
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`sued in this Court and through the assertions of counterclaims in suits against it brought in this
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`Court.
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`8.
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`This Court has personal jurisdiction over Mylan by virtue of, inter alia,
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`the fact that Mylan has availed itself of the rights and benefits of the laws of Delaware by
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`engaging in systematic and continuous contacts with Delaware.
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`9.
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`This Court has personal jurisdiction over Mylan by virtue of, inter alia,
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`these above-mentioned facts.
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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.
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`203985 for AFINITOR Disperz® (everolimus tablets for oral suspension) 2 mg, 3 mg and 5 mg
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`dosage strengths, which contain the active ingredient everolimus. AFINITOR Disperz®
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`(everolimus tablets for oral suspension) was approved by the United States Food and Drug
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`Administration (“FDA”) on August 29, 2012 (2 mg, 3 mg and 5 mg). AFINITOR Disperz®
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`(everolimus tablets for oral suspension) is indicated for the treatment of: pediatric and adult
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`patients with tuberous sclerosis complex who have subependymal giant cell astrocytoma that
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`requires therapeutic intervention but cannot be curatively resected. AFINITOR Disperz®
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`(everolimus tablets for oral suspension) 2 mg, 3 mg, and 5 mg dosage strengths are sold in the
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`United States by Plaintiff NPC.
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`12.
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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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`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 of 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. 8,778,962
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`(“the ’962 patent”). The ’962 patent was duly and legally issued on July 15, 2014.
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`16.
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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 B.
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`17.
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`Plaintiff Novartis AG is the owner of United States Letters Patent No.
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`8,617,598 (“the ’598 patent”). The ’598 patent was duly and legally issued on December 31,
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`2013.
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`18.
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`The ’598 patent claims, inter alia, certain pharmaceutical compositions in
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`the form of a dispersible tablet comprising a solid dispersion of everolimus, a disintegrant and
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`colloidal silicon dioxide. A true copy of the ’598 patent is attached as Exhibit C.
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`19.
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`On information and belief, Mylan submitted to the FDA an abbreviated
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`new 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, offer for sale and sale of everolimus tablets for oral
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`suspension in 2 mg, 3 mg and 5 mg dosage strengths (the “ANDA Products”) before the
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`expiration of the ’772, ’962 and ’598 patents.
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`20.
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`Plaintiffs received written notification of Mylan’s ANDA containing a §
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`355(j)(2)(A)(vii)(IV) certification by letter dated February 24, 2017 (“Notice Letter”), which
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`alleged that claims 1-3 and 7-10 of the ’772 patent are invalid and claims 4-6 of the ’772 patent
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`will not be infringed by Mylan, claims 1-6 of the ’962 patent are invalid, and claims 1-6 of the
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`’598 will not be infringed by Mylan. Mylan did not allege non-infringement of claims 1-3 and 7-
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`10 of the ’772 patent or claims 1-6 of the ’962 patent. Mylan also did not allege that any of the
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`claims of the ’772, ’962 and ’598 patents were unenforceable.
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`Letter.
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`21.
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`22.
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`This action was commenced within 45 days of receipt of the Mylan 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 Mylan’s ANDA Products
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`before the expiration of the ’772, ’962 and ’598 patents, Mylan has committed an act of
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`infringement under 35 U.S.C. § 271(e)(2).
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`23.
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`On information and belief, when Mylan filed its ANDA, it was aware of
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`the ’772, ’962 and ’598 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, ’962 and ’598 patents was an act of infringement of those
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`patents.
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`24.
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`On information and belief, the commercial manufacture, use, offer for
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`sale, or sale in the United States and/or importation into the United States of Mylan’s ANDA
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`Products will infringe one or more claims of the ’772, ’962 and ’598 patents.
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`25.
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`On information and belief, Mylan’s ANDA Products, if approved, will
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`contain everolimus and be a pharmaceutical composition containing a therapeutically effective
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`amount of everolimus and a pharmaceutically acceptable carrier. On information and belief, the
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`commercial manufacture, use, offer for sale, sale and/or importation of Mylan’s ANDA Products
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`will directly infringe the ’772 patent.
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`26. Mylan did not deny infringement of claims 1-3 and 7-10 of the ’772 patent
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`in its Notice Letter.
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`27.
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`On information and belief, Mylan’s ANDA Products, if approved, will
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`contain instructions for administering a therapeutically effective amount of everolimus to inhibit
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`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 Mylan’s ANDA
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`Products are approved, Mylan will actively induce, encourage, and abet this infringement with
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`knowledge of the ’962 patent, and that its acts will induce infringement of the ’962 patent.
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`28.
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`On information and belief, if Mylan’s ANDA Products are approved,
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`Mylan will commercially manufacture, offer for sale and/or sell those products, which will be
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`specifically labeled for use in a method for inhibiting growth of non-malignant solid tumors of
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`the brain in a subject, said method consisting of administering to said subject a therapeutically
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`effective amount of everolimus. On information and belief, if Mylan’s ANDA Products are
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`approved, those products will constitute a material part of 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 Mylan’s
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`ANDA Products are approved, Mylan will contributorily infringe the ’962 patent, and will do so
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`with knowledge of the ’962 patent, and that its ANDA Products are especially made or especially
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`adapted for use in infringing the ’962 patent and are not suitable for a substantial noninfringing
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`use.
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`29. Mylan did not deny infringement of claims 1-6 of the ’962 patent in its
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`Notice Letter.
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`30.
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`On information and belief, Mylan’s ANDA Products, if approved, will
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`contain a pharmaceutical composition in the form of a solid dispersion comprising everolimus, a
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`disintegrant and colloidal silicon dioxide. On information and belief, the commercial
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`manufacture, use, offer for sale, sale and/or importation of Mylan’s ANDA Products will directly
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`infringe the ’598 patent.
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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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`Mylan’s ANDA Products be a date that is no earlier than March 9, 2020, the expiration of the
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`’772 patent’s pediatric exclusivity, August 18, 2022, the expiration date of the ’962 patent’s
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`pediatric exclusivity, and March 27, 2023, the expiration of the ’598 patent’s pediatric
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`exclusivity, and an award of damages for any commercial sale or use of Mylan’s ANDA
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`Products and any act committed by Mylan with respect to the subject matter claimed in the ’772,
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`’598, and ’962 patents, which act is not within the limited exclusions of 35 U.S.C. § 271(e)(1).
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`32.
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`On information and belief, Mylan has taken and continues to take active
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`steps towards the commercial manufacture, use, offer for sale, sale, and/or importation of
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`Mylan’s ANDA Products, including seeking approval of those products under Mylan’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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`Mylan concerning the ’772, ’962 and ’598 patents. Plaintiffs are entitled to declaratory judgment
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`under 28 U.S.C. §§ 2201 and 2202 that Mylan will infringe, induce infringement of and/or
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`contributorily infringe one or more claims of the ’772, ’962 and ’598 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 Mylan has directly infringed, induced infringement of
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`and/or contributorily infringed one or more claims of the ’772, ’962 and ’598 patents by filing an
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`ANDA relating to Mylan’s everolimus tablets for oral suspension in 2 mg, 3 mg and 5 mg
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`dosage strengths;
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`B.
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`A permanent injunction restraining and enjoining Mylan 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 in the United States, or importation into
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`the United States, of Mylan’s everolimus tablets for oral suspension in 2 mg, 3 mg and 5 mg
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`dosage strengths, as claimed in the ’772, ’962 and ’598 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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`Mylan’s everolimus tablets for oral suspension in 2 mg, 3 mg and 5 mg dosage strengths be a
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`date that is not earlier than the expiration of the right of exclusivity under the ’772, ’962 and
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`’598 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 Mylan’s everolimus tablets for oral suspension in 2 mg, 3 mg and 5
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`mg dosage strengths will directly infringe, induce infringement of and/or contributorily infringe
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`one or more claims of the ’772, ’962 and ’598 patents;
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`E.
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`Damages from Mylan for the infringement, inducement of infringement
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`and contributory infringement of the ’772, ’962 and ’598 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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`Case 1:17-cv-00389-RGA Document 1 Filed 04/07/17 Page 10 of 10 PageID #: 10
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`McCARTER & ENGLISH, LLP
`
`/s/ Daniel M. Silver
`Daniel M. Silver (#4758)
`Benjamin A. Smyth (#5528)
`Renaissance Centre
`405 N. King Street, 8th Floor
`Wilmington, Delaware 19801
`(302) 984-6300
`dsilver@mccarter.com
`bsmyth@mccarter.com
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`Attorneys for Plaintiffs
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`Dated: April 7, 2017
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`Of Counsel:
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`Nicholas N. Kallas
`Charlotte Jacobsen
`FITZPATRICK, CELLA, HARPER & SCINTO
`1290 Avenue of the Americas
`New York, New York 10104-3800
`(212) 218-2100
`nkallas@fchs.com
`cjacobsen@fchs.com
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`
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`ME1 24559871v.1
`FCHS_WS 13309708v1.doc
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