Case 3:14-cv-05499-PGS-LHG Document 1 Filed 09/02/14 Page 1 of 13 PageID: 1
`
`Stephen M. Orlofsky
`David C. Kistler
`New Jersey Resident Partners
`BLANK ROME LLP
`301 Carnegie Center, 3d Floor
`Princeton, NJ 08540
`Telephone: (609) 750-7700
`
`OF COUNSEL:
`Douglas Carsten
`WILSON SONSINI GOODRICH & ROSATI
`12235 El Camino Real
`Suite 200
`San Diego, CA 92130
`
`William C. Jackson
`BOIES, SCHILLER & FLEXNER LLP
`5301 Wisconsin Ave, NW
`Washington, DC 20015
`
`Attorneys for Plaintiff
`United Therapeutics Corporation
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF NEW JERSEY
`
`Plaintiff,
`
`v.
`
`Civil Action No.:
`
`UNITED THERAPEUTICS CORPORATION )
`)
`)
`)
`)
`)
`)
`)
`)
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`SANDOZ, INC.,
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`Defendant.
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`COMPLAINT AND JURY DEMAND
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`Plaintiff United Therapeutics Corporation (“UTC”), by its undersigned attorneys, for its
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`Complaint against Defendant Sandoz, Inc. (“Sandoz”), alleges as follows:
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`NATURE OF THE ACTION
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`1.
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`This is an action for patent infringement arising under the patent laws of the
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`United States, Title 35, United States Code, Sections 100 et seq., involving United States Patent
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`8,497,393 (“the ’393 patent”) (attached as Exhibit A hereto).
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`2.
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`This action arises out of Sandoz’s submission of Abbreviated New Drug
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`Application (“ANDA”) No. 203649 to the United States Food and Drug Administration (the
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`“FDA”) seeking approval, prior to the expiration of the ’393 patent, to manufacture, market, and
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`sell a generic copy of UTC’s REMODULIN® (Treprostinil Sodium) Injection product which is
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`approved by the FDA for treatment of pulmonary arterial hypertension.
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`THE PARTIES
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`3.
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`UTC is a corporation organized and existing under the laws of the State of
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`Delaware, and having a place of business at 1040 Spring Street, Silver Spring, Maryland 20910.
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`UTC is a biotech company focused on the development and commercialization of products
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`designed to address the needs of patients with chronic and life-threatening conditions.
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`4.
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`Upon information and belief, Sandoz is a corporation organized and existing
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`under the laws of the State of Colorado and has its principal place of business at 506 Carnegie
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`Center, Suite 400, Princeton, New Jersey 08540.
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`JURISDICTION AND VENUE
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`5.
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`This Court has jurisdiction over the subject matter of this action pursuant to the
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`provisions of 28 U.S.C. §§ 1331, 1338(a), 2201 and 2202.
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`6.
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`7.
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`Venue is proper in this Court under 28 U.S.C. §§ 1391 and 1400(b).
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`Upon information and belief, this Court has personal jurisdiction over Sandoz
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`with respect to this Complaint because, inter alia, of its continuous and systematic contacts with
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`this judicial district where it maintains its principal place of business. Upon information and
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`belief, Sandoz derives substantial revenue from articles used and consumed in this judicial
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`district and, consistent with its practice with respect to other generic products, following any
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`FDA approval of Sandoz’s ANDA, Sandoz will sell its generic product throughout the United
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`States, including in New Jersey. In addition, Sandoz has previously availed itself of this Court as
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`a forum in which to bring patent litigation against others. See, e.g., Sandoz v. Eli Lilly and Co.,
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`Civil Action No. 2:07-cv-04100-DMC-MF (D.N.J.).
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`8.
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`In addition, the acts giving rise to this action are centered in New Jersey and
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`Sandoz has consented to the jurisdiction and venue of New Jersey. By letter dated July 23, 2014,
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`Sandoz “of 506 Carnegie Center, Suite 400, Princeton, NJ 08540,” gave notice of the acts giving
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`rise to this action. The letter identified the relevant contact for “any inquiries concerning or for
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`any service of process or legal information” as the Head of U.S. Patent Litigation of Sandoz Inc.
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`located in Sandoz’s Princeton, NJ offices. Sandoz’s accompanying Offer of Confidential Access
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`Pursuant to 21 U.S.C. § 355(j)(5)(C)(i)(III) requested that UTC agree that any claims for breach
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`of that agreement granting confidential access “may be brought in courts located in the State of
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`New Jersey and consent to the jurisdiction and venue of such courts for any such claims.” Thus,
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`Sandoz is availing itself of New Jersey in connection with its ANDA, making jurisdiction and
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`venue proper in New Jersey.
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`9.
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`Additionally, another matter involving Sandoz’s ANDA No. 203649 and certain
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`patents assigned to UTC (specifically, United States Patent Nos. 5,153,222 (“the ’222 patent”),
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`6,765,117 (“the ’117 patent”), and 7,999,007 (“the ’007 patent”)) is being litigated in this Court.
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`Trial in that matter concluded in June of this year. On August 29, 2014, the Court entered an
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`opinion holding that Sandoz had not proved invalidity of either the ’117 or ’007 patent and that
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`Sandoz infringed the ’117 patent, but not the ’007 patent.
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`BACKGROUND
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`10.
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`UTC holds an approved New Drug Application (No. 21-272) for Treprostinil
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`Sodium Injection, which UTC markets and sells under the registered trademark REMODULIN®.
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`11.
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`REMODULIN® is a pharmaceutical product initially approved in the United
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`States in May 2002, and is indicated for the treatment of pulmonary arterial hypertension.
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`Pulmonary arterial hypertension is a rare disease affecting the pulmonary vasculature and
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`resulting in high pressure in the pulmonary arteries and decreased blood flow from the heart to
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`the lungs, thereby depriving the body of oxygen.
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`12.
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`REMODULIN® is an injectable product approved for sale in 1 mg/mL, 2.5
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`mg/mL, 5 mg/mL, and 10 mg/mL concentrations.
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`13.
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`The ’393 patent, entitled “Process to Prepare Treprostinil, the Active Ingredient in
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`Remodulin®,” was duly and legally issued by the United States Patent and Trademark Office on
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`July 30, 2014, and is scheduled to expire December 15, 2028. The named inventors are Hitesh
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`Batra, Sudersan M. Tuladhar, Raju Penmasta, and David A. Walsh.
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`14.
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`UTC is the lawful owner of the ’393 patent by assignment of all right, title, and
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`interest in and to the ’393 patent, including the right to bring infringement suits thereon.
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`15.
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`REMODULIN® and its manufacture are covered by one or more claims of the
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`’393 patent, which has been listed in connection with REMODULIN® in the FDA’s Approved
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`Drug Products with Therapeutic Equivalents publication (also known as the “Orange Book”).
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`ACTS GIVING RISE TO THIS ACTION
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`16.
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`Sandoz notified UTC in a letter dated February 2, 2012 (“Sandoz’s First Notice
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`Letter”), that it had filed ANDA No. 203649 with the FDA, seeking approval to commercially
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`manufacture, market, use and sell a generic copy of REMODULIN® (Treprostinil Sodium)
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`Injection, 200 mg/20 mL (10 mg/mL), prior to the expiration of the ’222 patent, the ’117 patent,
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`and the ’007 patent.
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`17.
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`Sandoz notified UTC in a letter dated December 7, 2012 (“Sandoz’s Second
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`Notice Letter”), that it had amended it previously-filed ANDA No. 203649 to seek FDA approval
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`to commercially manufacture, market, use and sell generic copies of REMODULIN®
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`(Treprostinil Sodium) Injection, 20 mg/20 mL (1 mg/mL), 50 mg/20 mL (2.5 mg/mL), and 100
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`mg/20 mL (5 mg/mL) (collectively, together with the 200 mg/20 mL (10 mg/mL) dosage strength
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`covered by Sandoz’s First Notice Letter, “Sandoz’s ANDA Products”), prior to the expiration of
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`the ’222 patent, the ’117 patent, and the ’007 patent.
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`18.
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`Sandoz notified UTC in a letter dated July 23, 2014 (“Sandoz’s Third Notice
`
`Letter”) that it had again amended ANDA No. 203649, now seeking approval to commercially
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`manufacture, market, use and sell generic copies of REMODULIN® (Treprostinil Sodium)
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`Injection, 20 mg/20 mL (1 mg/mL), 50 mg/20 mL (2.5 mg/mL), 100 mg/20 mL (5 mg/mL), and
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`200mg/20mL (10mg/mL) (“Sandoz’s ANDA Products”) prior to the expiration of the ’393 patent.
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`19.
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`Upon information and belief, Sandoz amended ANDA No. 203649 with the FDA
`
`seeking approval to commercially manufacture, market, use and sell generic copies of
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`REMODULIN® (Treprostinil Sodium) Injection, 20 mg/20 mL (1 mg/mL), 50 mg/20 mL (2.5
`
`mg/mL), 100 mg/20 mL (5 mg/mL), and 200mg/20mL (10mg/mL) prior to the expiration of the
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`’393 patent.
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`20.
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`Sandoz’s Third Notice Letter was accompanied by an Offer of Confidential Access
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`pursuant to 21 U.S.C. § 355(j)(5)(C)(i)(III).
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`21.
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`Upon information and belief, Sandoz submitted its amended ANDA No. 203649
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`to obtain FDA approval to engage in the commercial manufacture, use and sale of Sandoz’s
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`ANDA Products prior to the expiration of the ’393 patent.
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`22.
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`Sandoz’s Third Notice Letter included a statement pursuant to 21 U.S.C. §
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`355(j)(2)(vii)(IV) purporting to recite Sandoz’s “factual and legal bases” for its opinion that the
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`’393 patent is not valid and/or would not be infringed by the commercial manufacture, use, or
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`sale of Sandoz’s ANDA Products.
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`23.
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`UTC is commencing this action before the expiration of forty-five days from the
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`date UTC received Sandoz’s Third Notice Letter.
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`24.
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`Upon information and belief, Sandoz’s ANDA Products contains the same active
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`compound as UTC’s approved REMODULIN® product.
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`25.
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`Upon information and belief, Sandoz’s ANDA No. 203649 seeks approval from
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`the FDA to market Sandoz’s ANDA Products for the same indication as UTC’s approved
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`REMODULIN® product.
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`26.
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`Upon information and belief, Sandoz represented to the FDA in ANDA No.
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`203649 that Sandoz’s ANDA Products is bioequivalent to UTC’s approved REMODULIN®
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`product.
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`27.
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`Upon information and belief, Sandoz intends to commercially manufacture, sell,
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`offer for sale, and/or import Sandoz’s ANDA Products upon, or in anticipation of, FDA
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`approval.
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`28.
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`According to Sandoz’s Third Notice Letter, Sandoz’s ANDA No. 203649
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`contained a “Paragraph IV” certification pursuant to 21 U.S.C. § 355(j)(2)(vii)(IV) stating that in
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`Sandoz’s opinion ’393 patent is invalid and/or would not be infringed by the manufacture, use or
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`sale of Sandoz’s ANDA Products.
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`29.
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`Upon information and belief, Sandoz was aware of the ’393 patent when Sandoz
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`filed ANDA No. 203649 containing the Paragraph IV certification for the ’393 patent, which was
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`on or before July 23, 2014.
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`30.
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`Upon information and belief, as of the date of Sandoz’s Third Notice Letter,
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`Sandoz was aware of the statutory provisions and regulations set forth in 21 U.S.C. §§
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`355(j)(2)(B)(iv)(II) and 21 C.F.R. § 314.95(c)(6).
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`COUNT 1: INFRINGEMENT OF THE ’393 PATENT UNDER 35 U.S.C. § 271(e)
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`31.
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`UTC repeats and realleges each of the foregoing paragraphs as if fully set forth
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`herein.
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`32.
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`Upon information and belief, Sandoz’s ANDA Products or an intermediate in
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`their manufacture is covered by one or more claims of the ’393 patent.
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`33.
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`Sandoz’s submission of ANDA No. 203649 with a Paragraph IV certification for
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`the ’393 patent for the purpose of obtaining approval to engage in the commercial manufacture,
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`use, sale, and/or offer for sale of Sandoz’s ANDA Products was an act of infringement of the
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`’393 patent under 35 U.S.C. § 271(e)(2).
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`34.
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`Upon information and belief, the commercial manufacture, use, offer for sale, sale
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`and/or importation of Sandoz’s ANDA Products would infringe one or more claims of the ’393
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`patent.
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`35.
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`Upon information and belief, Sandoz was and is aware of the existence of the
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`’393 patent and acted without a reasonable basis for believing that it would not be liable for
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`infringement of the ’393 patent, thus rendering this case “exceptional” under 35 U.S.C. § 285.
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`36.
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`UTC will be substantially and irreparably damaged and harmed if Sandoz’s
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`infringement of the ’393 patent is not enjoined by this Court. UTC does not have an adequate
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`remedy at law.
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`COUNT 2: INFRINGEMENT OF THE ’393 PATENT UNDER 35 U.S.C. §§ 271(a)-(c) and
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`37.
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`UTC repeats and realleges each of the foregoing paragraphs as if fully set forth
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`(g)
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`herein.
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`38.
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`Upon information and belief, upon FDA approval Sandoz will manufacture,
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`market, sell, offer to sell, import, and distribute Sandoz’s ANDA Products which will result in
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`infringement of one or more claims of the ’393 patent.
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`39.
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`Sandoz’s ANDA and Sandoz’s intention to engage in the commercial
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`manufacture, use, offer for sale, sale, or importation of Sandoz’s ANDA Products upon receiving
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`FDA approval prior to the expiration of the ’393 patent creates an actual and justiciable
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`controversy with respect to infringement of the ’393 patent.
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`40.
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`Upon information and belief, upon FDA approval of Sandoz’s ANDA, Sandoz’s
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`commercial manufacture, use, sale offer for sale and/or importation into the United States of
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`Sandoz’s ANDA Products will directly infringe one or more claims of the ’393 patent, and will
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`indirectly infringe by actively inducing infringement by others, under 35 U.S.C. § 271(a), 35
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`U.S.C. § 271(b), 35 U.S.C. § 271(c) and/or 35 U.S.C. § 271(g).
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`41.
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`Upon information and belief, Sandoz’s ANDA Products or an intermediate in its
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`manufacture as described in and/or directed by Sandoz’s proposed labeling, ANDA, applicable
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`DMF, and/or other corporate documents for Sandoz’s ANDA Products would infringe one or
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`more claims of the ’393 patent.
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`42.
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`Upon information and belief, Sandoz will induce others to infringe one or more
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`claims of the ’393 patent under 35 U.S.C. § 271(b) by, among other things, actively and
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`knowingly aiding and abetting others to infringe, including, but not limited to the manufacturer
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`of Sandoz’s ANDA Products, or its Active Pharmaceutical Ingredient (“API”), or other
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`subsequent purchasers, distributors, or users thereof, which product or its manufacture
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`constitutes direct infringement of one or more claims of the ’393 patent. Upon information and
`
`belief, Sandoz’s aiding and abetting includes Sandoz’s engagement of, contracting of, and/or
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`encouragement of others to engage in the manufacture, use, sale, or importation of infringing
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`products pursuant to Sandoz’s ANDA.
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`43.
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`Upon information and belief, Sandoz will also contributorily infringe one or more
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`claims of the ’393 patent under 35 U.S.C. § 271(c) in that Sandoz will make, use, sell, offer to
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`sell, and/or import its ANDA Products and/or the API thereof, which Sandoz knows does not
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`have substantial non-infringing uses.
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`44.
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`Upon information and belief, Sandoz will also infringe one or more claims of the
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`’393 patent under 35 U.S.C. § 271(g) by importing, selling, offering to sell or using Sandoz’s
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`ANDA Products or the API or an intermediate thereof which is neither materially changed by
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`subsequent process nor a trivial or non-essential component of another product.
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`45.
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`Upon information and belief, Sandoz was and is aware of the existence of the
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`’393 patent and acted without a reasonable basis for believing that it would not be liable for
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`infringement of the ’393 patent, thus rendering this case “exceptional” under 35 U.S.C. § 285
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`46.
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`UTC will be substantially and irreparably damaged and harmed if Sandoz’s
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`infringement of the ’393 patent is not enjoined by this Court. UTC does not have an adequate
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`remedy at law.
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`
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`PRAYER FOR RELIEF
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`WHEREFORE, UTC requests the following relief:
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`1.
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`A judgment that Sandoz:
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`A. has infringed the ’393 patent,
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`B. will induce infringement of the ’393 patent, and
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`C. will contribute to the infringement by others the ’393 patent;
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`2.
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`A judgment ordering that the effective date of any FDA approval for Sandoz to
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`commercially manufacture, make, use, offer to sell, sell, market, or import into the United States
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`Sandoz’s ANDA Products be not earlier than the latest of the expiration date of the ’393 patent,
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`inclusive of any extension(s) and additional period(s) of exclusivity to which UTC is or may
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`become entitled;
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`3.
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`A judgment pursuant to 35 U.S.C. § 271(e)(4)(B) preliminarily and permanently
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`enjoining Sandoz, its officer, agents, servants, employees, parents, subsidiaries, affiliate
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`corporations, other business entities and all other persons acting in concert, participation, or
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`privity with them, their successors, and assigns, from infringing, contributorily infringing, or
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`inducing others to infringe the ’393 patent, including engaging in the commercial manufacture,
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`use, sale, offer to sale and/or importation in the United States of the product that is the subject of
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`ANDA No. 203649 and/or any applicable DMF until the expiration of the ’393 patent inclusive
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`of any extension(s) and additional period(s) of exclusivity to which UTC is or may become
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`entitled;
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`4.
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`A judgment declaring that making, using, selling, offering for sale, or importing
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`into the United States of Sandoz’s ANDA Products, or any product or compound that infringes
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`the ’393 patent, prior to the expiration dates of the ’393 patent, will infringe, actively induce
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`infringement of, and will contribute to the infringement by others of the’393 patent;
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`5.
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`Temporary, preliminary, permanent, or other injunctive relief as necessary or
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`appropriate should Sandoz seek to commercially manufacture, use, sell, offer to sell, or import
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`Sandoz’s ANDA Products prior to disposition of this action and/or the expiration of the ’393
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`patent;
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`6.
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`A judgment awarding UTC damages or other monetary relief, pursuant to 35
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`U.S.C. §§ 271(e)(4)(c) and 284, if Sandoz commercially manufactures, uses, sells, offers to sell
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`and/or imports any product that is the subject of ANDA No. 203649 that infringes the ’393
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`patent;
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`7.
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`A judgment declaring that, pursuant to 35 U.S.C. § 285, this is an exceptional
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`case and awarding UTC its attorney’s fees;
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`8.
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`9.
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`Costs and expenses in this action; and
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`Such further and other relief as this Court may deem just and proper.
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`JURY DEMAND
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`UTC requests trial by jury for any issues so triable.
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` Respectfully submitted,
`
`s/ Stephen M. Orlofsky
`Stephen M. Orlofsky
`David C. Kistler
`New Jersey Resident Partners
`BLANK ROME LLP 301
`Carnegie Center, 3d Floor
`Princeton, NJ 08540
`Telephone: (609) 750-7700
`
`Of Counsel
`
`Douglas Carsten
`WILSON SONSINI GOODRICH & ROSATI
`12235 El Camino Real
`Suite 200
`San Diego, CA 92130
`
`Shaun R. Snader
`Veronica S. Ascarrunz
`WILSON SONSINI GOODRICH & ROSATI
`1700 K Street, NW
`Suite 500
`Washington, DC 20006
`
`William C. Jackson
`BOIES, SCHILLER & FLEXNER LLP
`5301 Wisconsin Ave, NW
`Washington, DC 20015
`
`
`Dated: September 2, 2014
`
`
`Attorneys for Plaintiff
`United Therapeutics Corporation
`
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`LOCAL CIVIL RULE 11.2 CERTIFICATION
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`UTC hereby certifies that, to its knowledge, the matter in controversy in this action is not
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`the subject of any other pending lawsuit, arbitration, or administrative proceeding other than the
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`following identified proceedings:
`
`• United Therapeutics Corporation v. Sandoz, Inc. (3:12-cv-01617-PGS-LHG)
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`(D.N.J.);
`
`• United Therapeutics Corporation v. Sandoz, Inc. et al. (3:13-cv-00316-PGS-
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`LHG) (D.N.J.).
`
`Respectfully submitted,
`
`s/ Stephen M. Orlofsky
`Stephen M. Orlofsky
`David C. Kistler
`New Jersey Resident Partners
`BLANK ROME LLP 301
`Carnegie Center, 3d Floor
`Princeton, NJ 08540
`Telephone: (609) 750-7700
`
`Attorneys for Plaintiff
`United Therapeutics Corporation
`
`Of Counsel
`
`Douglas Carsten
`WILSON SONSINI GOODRICH & ROSATI
`12235 El Camino Real
`Suite 200
`San Diego, CA 92130
`
`Shaun R. Snader
`Veronica S. Ascarrunz
`WILSON SONSINI GOODRICH & ROSATI
`1700 K Street, NW
`Suite 500
`Washington, DC 20006
`
`William C. Jackson
`BOIES, SCHILLER & FLEXNER LLP
`5301 Wisconsin Ave, NW
`Washington, DC 20015
`
`Dated: September 2, 2014
`
`
`
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