Case 3:15-cv-05723-PGS-LHG Document 1 Filed 07/22/15 Page 1 of 21 PageID: 1
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`
`
`William J. O’Shaughnessy
`MCCARTER & ENGLISH LLP
`Four Gateway Center
`100 Mulberry Street
`Newark, NJ 07102
`(973) 639-2094
`woshaughnessy@mccarter.com
`
`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 Avenue, NW
`Washington, DC 20015
`
`Attorneys for Plaintiff
`United Therapeutics Corporation
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF NEW JERSEY
`
`Plaintiff,
`
`v.
`
`
`UNITED THERAPEUTICS CORPORATION )
`)
`)
`)
`) Civil Action No.:
`)
`)
`)
`)
`)
`
`WATSON LABORATORIES, INC.,
`
`Defendant.
`
`COMPLAINT AND JURY DEMAND
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`Plaintiff United Therapeutics Corporation (“UTC”), by its undersigned attorneys, for its
`
`Complaint against Watson Laboratories, Inc. (“Watson”), alleges as follows:
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`1
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`
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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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`Nos. 6,521,212 (“the ’212 patent”) (attached as Exhibit A hereto), 6,756,033 (“the ’033 patent”)
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`(attached as Exhibit B hereto), and 8,497,393 (the ’393 patent”) (attached as Exhibit C hereto).
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`2.
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`This action arises out of Watson’s submission of Abbreviated New Drug
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`Application (“ANDA”) No. 208172 to the United States Food and Drug Administration (the
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`“FDA”) seeking approval, prior to the expiration of the ’212, ’393, and ’033 patents, to
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`manufacture, market, and sell a generic copy of UTC’s TYVASO® (treprostinil) Inhalation
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`Solution, 0.6 mg/ml that is approved by the FDA for treatment of pulmonary arterial
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`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, Watson is a corporation organized and existing
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`under the laws of the State of California and has a principal place of business at Morris
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`Corporate Center III, 400 Interpace Parkway, Parsippany, New Jersey 07054.
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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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`Venue is proper in this Court under 28 U.S.C. §§ 1391 and 1400(b).
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`2
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`7.
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`Upon information and belief, this Court has personal jurisdiction over Watson
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`with respect to this Complaint because of, inter alia, its continuous and systematic contacts with
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`this judicial district. The notice letter was sent from Watson at Morris Corporate Center III, 400
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`Interpace Parkway, Parsippany, New Jersey, NJ 07054. Upon information and belief, Watson
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`derives substantial revenue from articles used and consumed in this judicial district and,
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`consistent with its practice with respect to other generic products, following any FDA approval
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`of Watson’s ANDA, Watson will sell its generic product throughout the United States, including
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`in New Jersey. Upon information and belief, Watson is registered to conduct business in the
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`State of New Jersey and employs people throughout New Jersey, including at least the following
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`locations: Morris Corporate Center III, 400 Interpace Parkway, Parsippany, New Jersey 07054;
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`100 Enterprise Drive, Rockaway, New Jersey 07866; and 350 Mt. Kemble Avenue, Morristown,
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`New Jersey 07960. In addition, Watson has previously availed itself of this Court as a forum in
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`which to bring patent litigation against others.
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`BACKGROUND
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`8.
`
`UTC holds an approved New Drug Application (No. 22-387) for TYVASO®
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`(treprostinil) Inhalation Solution, 0.6 mg/ml, which UTC markets and sells under the registered
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`trademark TYVASO®.
`
`9.
`
`TYVASO® is a pharmaceutical product initially approved by FDA in the United
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`States in July 2009, 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 results
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`in high pressure in the pulmonary arteries, which increases strain on the right ventricle of the
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`heart, thereby leading to heart failure and death.
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`3
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`10.
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`TYVASO® is an inhalable product approved for sale in a 0.6 mg/mL
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`concentration.
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`11.
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`The ’212 patent, entitled “Method for treating peripheral vascular disease by
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`administering benzindene prostaglandins by inhalation” was duly and legally issued by the
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`United States Patent and Trademark Office on February 18, 2003, and is scheduled to expire on
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`November 13, 2018. The named inventors are Gilles Cloutier, James Crow, Michael Wade,
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`Richard E. Parker, and James E. Loyd.
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`12.
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`UTC is the lawful owner of the ’212 patent by assignment of all right, title and
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`interest in and to the ’212 patent, including the right to bring infringement suits thereon.
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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
`
`Batra, Sudersan M. Tuladhar, Raju Penmasta, and David A. Walsh.
`
`14.
`
`UTC is the lawful owner of the ’393 patent by assignment of all right, title and
`
`interest in and to the ’393 patent, including the right to bring infringement suits thereon.
`
`15.
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`The ’033 patent, entitled “Method for delivering benzindene prostaglandins by
`
`inhalation,” was duly and legally issued by the United States Patent and Trademark Office on
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`June 29, 2004, and is scheduled to expire on November 13, 2018. The named inventors are
`
`Gilles Cloutier, James Crow, Michael Wade, Richard E. Parker, and James E. Loyd.
`
`16.
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`UTC is the lawful owner of the ’033 patent by assignment of all right, title and
`
`interest in and to the ’033 patent, including the right to bring infringement suits thereon.
`
`17.
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`TYVASO® and its FDA approved manufacture and uses are covered by one or
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`more claims of the ’212 patent, the ’033 patent, and the ’393 patent, which have been listed in
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`
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`4
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`

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`
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`connection with TYVASO® in the FDA’s Approved Drug Products with Therapeutic
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`Equivalents publication (also known as the “Orange Book”).
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`ACTS GIVING RISE TO THIS ACTION
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`18. Watson notified UTC by letter dated June 12, 2015, which was delivered to UTC
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`on or about, Saturday, June 13, 2015 (“Watson’s Notice Letter”), that it had filed ANDA No.
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`208172 with the FDA seeking approval to commercially manufacture, market, use, and sell
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`generic copies of TYVASO® (treprostinil) Inhalation Solution, 0.6 mg/mL (“Watson’s ANDA
`
`Product”) prior to the expiration of the ’212,’033, and ’393 patents.
`
`19. Watson’s Notice Letter included a statement pursuant to 21 U.S.C. §
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`355(j)(2)(vii)(IV) purporting to recite Watson’s “factual and legal basis” for its opinion that the
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`’212, ’033, and ’393 patents are not valid, are unenforceable, and/or would not be infringed by
`
`the commercial manufacture, use, or sale of Watson’s ANDA Product. Yet that statement did not
`
`include any explanation as to why claims 1-5 and 9-12 of the ’212 patent, claims 4 and 6-10 of the
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`’033 patent, and any claim of the ’393 patent were invalid. The statement also did not include
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`anything beyond conclusory statements as to why claims 6-8 of the ’212 patent and claims 1-3
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`and 5 of the ’033 patent were invalid. The statement also did not include anything beyond
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`conclusory statements regarding alleged non-infringement. Watson provided no explanation as to
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`the alleged unenforceability.
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`20.
`
`Upon information and belief, Watson submitted ANDA No. 208172 with the
`
`FDA seeking approval to commercially manufacture, market, use, and sell generic copies of
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`TYVASO® (treprostinil) Inhalation Solution, 0.6 mg/mL (“Watson’s ANDA Product”) prior to
`
`the expiration of the ’212, ’033, and ’393 patents.
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`5
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`21.
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`UTC is commencing this action before the expiration of forty-five days from the
`
`date UTC received Watson’s Notice Letter.
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`22.
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`Upon information and belief, Watson’s ANDA Product contains the same active
`
`compound as UTC’s approved TYVASO® product.
`
`23.
`
`Upon information and belief, Watson’s ANDA No. 208172 seeks approval from
`
`the FDA to market Watson’s ANDA Product for the same indication as UTC’s approved
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`TYVASO® product.
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`24.
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`Upon information and belief, Watson represented to the FDA in ANDA No.
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`208172 that Watson’s ANDA Product is bioequivalent to UTC’s approved TYVASO® product.
`
`25.
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`Upon information and belief, Watson intends to commercially manufacture, sell,
`
`offer for sale, and/or import Watson’s ANDA Product upon, or in anticipation of, FDA approval.
`
`26.
`
`According to Watson’s Notice Letter, Watson’s ANDA No. 208172 contained a
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`“Paragraph IV” certification pursuant to 21 U.S.C. § 355(j)(2)(vii)(IV) stating that in Watson’s
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`opinion the ’212, ’033, and ’393 patents are invalid, unenforceable, and/or would not be
`
`infringed by the manufacture, use or sale of Watson’s ANDA Product.
`
`27.
`
`Upon information and belief, as of the date of Watson’s Notice Letter, Watson
`
`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).
`
`28.
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`Upon information and belief, the acts of infringement by Watson have been
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`intentional and willful.
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`29.
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`In Watson’s Notice Letter, Watson offered confidential access to portions of the
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`Watson ANDA on terms and conditions set forth in paragraph VII of the Watson Notice Letter
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`(“Watson Offer”). Watson requested that UTC accept the Watson Offer before receiving access
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`6
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`
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`to any portion of the Watson ANDA. The Watson Offer contained sweeping, unreasonable
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`restrictions that differ materially from restrictions found under protective orders, such as those
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`protective orders in pending, related cases in the United States District Court for the District of
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`New Jersey. For example, the Watson Offer required that UTC’s outside counsel “do not
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`engage, formally or informally, in any patent prosecution for United Therapeutics or any FDA
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`counseling, litigation or other work before or involving the FDA.”
`
`30.
`
`Under 21 U.S.C. § 355(j)(5)(C)(i)(III), an “offer of confidential access shall
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`contain such restrictions . . . on the use and disposition of any information accessed, as would
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`apply had a protective order been entered for the purpose of protecting trade secrets and other
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`confidential business information.”
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`31.
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`UTC attempted to negotiate with Watson to obtain relevant information from the
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`Watson ANDA under restrictions “as would apply had a protective order been issued.” Those
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`negotiations were unsuccessful. For example, Watson continued to insist that attorneys
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`representing UTC and in-house counsel and the staff of such counsel agree not to be engaged in
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`the drafting of submissions related to compositions, treatment methods, or formulations
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`containing treprostinil to the FDA or any FDA counseling related to such matters, though such a
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`restrictions has not been present in any prior protective order relating to any other UTC
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`treprostinil-containing product, such as REMODULIN® (treprostinil) Injection. See United
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`Therapeutics Corp. v. Sandoz, Inc., 3:12-cv-01617-PGS-LHG, Protective Order, Docket No. 32
`
`(D.N.J. Sept. 12, 2012); United Therapeutics Corp. v. Teva Pharmaceuticals USA, Inc., 3:14-cv-
`
`05498-PGS-LHG, Protective Order, Docket No. 24, Discovery Confidentiality Order (D.N.J.
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`Nov. 25, 2014); United Therapeutics Corp. v. Sandoz, Inc., 3:14-cv-05499-PGS-LHG, Stipulated
`
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`7
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`
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`Protective Order and Cross Use Agreement (D.N.J. Jan. 15, 2015.). UTC objected to this
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`provision of Watson’s OCA as unreasonable and in violation of 21 U.S.C. 355(j)(5)(C)(i)(III).
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`32.
`
`UTC is not aware of any other means of obtaining information regarding
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`Watson’s ANDA Product within the 45-day statutory period. Without such information, UTC
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`will use the judicial process and the aid of discovery to obtain, under appropriate judicial
`
`safeguards, such information as is required to confirm its allegations of infringement and to
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`present to the Court evidence that Watson’s ANDA Product fall within the scope of one or more
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`claims of the ’212 patent, the ’393 patent, and the ’033 patent.
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`COUNT 1 INFRINGEMENT OF THE ’212 PATENT UNDER 35 U.S.C. § 271(e)
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`33.
`
`UTC repeats and realleges each of the foregoing paragraphs as if fully set forth
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`herein.
`
`34.
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`Upon information and belief, Watson’s ANDA Product or an intermediate in its
`
`manufacture is covered by one or more claims of the ’212 patent.
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`35. Watson had knowledge of the ’212 patent when it submitted ANDA No. 208172.
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`36. Watson’s submission of ANDA No. 208172 for the purpose of obtaining approval
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`to engage in the commercial manufacture, use, sale, and/or offer for sale of Watson’s ANDA
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`Product was an act of infringement of the ’212 patent under 35 U.S.C. § 271(e)(2).
`
`37.
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`Upon information and belief, the commercial manufacture, use, offer for sale, sale
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`and/or importation of Watson’s ANDA Product would infringe one or more claims of the ’212
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`patent.
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`38.
`
`Upon information and belief, Watson was and is aware of the existence of the
`
`’212 patent and acted without a reasonable basis for believing that it would not be liable for
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`infringement of the ’212 patent, thus rendering this case “exceptional” under 35 U.S.C. § 285.
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`8
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`39.
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`UTC will be substantially and irreparably damaged and harmed if Watson’s
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`infringement of the ’212 patent is not enjoined by this Court. UTC does not have an adequate
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`remedy at law.
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`40.
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`Upon information and belief, the acts of infringement by Watson have been
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`intentional and willful.
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`COUNT 2: INFRINGEMENT OF THE ’212 PATENT
`UNDER 35 U.S.C. §§ 271(a)-(c) and (g)
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`41.
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`UTC repeats and realleges each of the foregoing paragraphs as if fully set forth
`
`herein.
`
`42.
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`Upon information and belief, upon FDA approval Watson will manufacture,
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`market, sell, offer to sell, import, and distribute Watson’s ANDA Products which will result in
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`infringement of one or more claims of the ’212 patent.
`
`43. Watson’s ANDA and Watson’s intention to engage in the commercial
`
`manufacture, use, offer for sale, sale, or importation of Watson’s ANDA Product upon receiving
`
`FDA approval prior to the expiration of the ’212 patent creates an actual and justiciable
`
`controversy with respect to infringement of the ’212 patent.
`
`44.
`
`Upon information and belief, upon FDA approval of Watson’s ANDA, Watson’s
`
`commercial manufacture, use, sale offer for sale and/or importation into the United States of
`
`Watson’s ANDA Product will directly infringe one or more claims of the ’212 patent, and will
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`indirectly infringe by actively inducing infringement by others, under 35 U.S.C. § 271(a), 35
`
`U.S.C. § 271(b), 35 U.S.C. § 271(c) and/or 35 U.S.C. § 271(g).
`
`45.
`
`Upon information and belief, Watson’s ANDA Product or an intermediate in its
`
`manufacture as described in and/or directed by Watson’s proposed labeling, ANDA, applicable
`
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`9
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`
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`DMF, and/or other corporate documents for Watson’s ANDA Product would infringe one or
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`more claims of the ’212 patent.
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`46.
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`Upon information and belief, Watson will induce others to infringe one or more
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`claims of the ’212 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
`
`of Watson’s ANDA Product, 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 ’212 patent. Upon information and
`
`belief, Watson’s aiding and abetting includes Watson’s engagement of, contracting of, and/or
`
`encouragement of others to engage in the manufacture, use, sale, or importation of infringing
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`products pursuant to Watson’s ANDA.
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`47.
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`Upon information and belief, Watson will also contributorily infringe one or more
`
`claims of the ’212 patent under 35 U.S.C. § 271(c) in that Watson will make, use, sell, offer to
`
`sell, and/or import its ANDA Product and/or the API thereof, which Watson knows has no
`
`substantial non-infringing uses. Upon information and belief, subsequent purchasers,
`
`distributors, or users thereof will also directly infringe one or more claims of the ’212 patent.
`
`48.
`
`Upon information and belief, Watson will also infringe one or more claims of the
`
`’212 patent under 35 U.S.C. § 271(g) by importing, selling, offering to sell or using Watson’s
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`ANDA Product or the API or an intermediate thereof which is neither materially changed by
`
`subsequent process nor a trivial or non-essential component of another product.
`
`49.
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`Upon information and belief, Watson was and is aware of the existence of the
`
`’212 patent and acted without a reasonable basis for believing that it would not be liable for
`
`infringement of the ’212 patent, thus rendering this case “exceptional” under 35 U.S.C. § 285.
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`10
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`50.
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`UTC will be substantially and irreparably damaged and harmed if Watson’s
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`infringement of the ’212 patent is not enjoined by this Court. UTC does not have an adequate
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`remedy at law.
`
`51.
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`Upon information and belief, the acts of infringement by Watson will be
`
`intentional and willful.
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`COUNT 3: INFRINGEMENT OF THE ’393 PATENT UNDER 35 U.S.C. § 271(e)
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`52.
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`UTC repeats and realleges each of the foregoing paragraphs as if fully set forth
`
`herein.
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`53.
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`Upon information and belief, Watson’s ANDA Product or an intermediate in its
`
`manufacture is covered by one or more claims of the ’393 patent.
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`54. Watson had knowledge of the ’393 patent when it submitted ANDA No. 208172.
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`55. Watson’s submission of ANDA No. 208172 for the purpose of obtaining approval
`
`to engage in the commercial manufacture, use, sale, and/or offer for sale of Watson’s ANDA
`
`Product was an act of infringement of the ’393 patent under 35 U.S.C. § 271(e)(2).
`
`56.
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`Upon information and belief, the commercial manufacture, use, offer for sale, sale
`
`and/or importation of Watson’s ANDA Product would infringe one or more claims of the ’393
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`patent.
`
`57.
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`Upon information and belief, Watson was and is aware of the existence of the
`
`’393 patent and acted without a reasonable basis for believing that it would not be liable for
`
`infringement of the ’393 patent, thus rendering this case “exceptional” under 35 U.S.C. § 285.
`
`58.
`
`UTC will be substantially and irreparably damaged and harmed if Watson’s
`
`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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`59.
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`Upon information and belief, the acts of infringement by Watson have been
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`intentional and willful.
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`COUNT 4: INFRINGEMENT OF THE ’393 PATENT
`UNDER 35 U.S.C. §§ 271(a)-(c) and (g)
`
`60.
`
`UTC repeats and realleges each of the foregoing paragraphs as if fully set forth
`
`herein.
`
`61.
`
`Upon information and belief, upon FDA approval Watson will manufacture,
`
`market, sell, offer to sell, import, and distribute Watson’s ANDA Product which will result in
`
`infringement of one or more claims of the ’393 patent.
`
`62. Watson’s ANDA and Watson’s intention to engage in the commercial
`
`manufacture, use, offer for sale, sale, or importation of Watson’s ANDA Product upon receiving
`
`FDA approval prior to the expiration of the ’393 patent creates an actual and justiciable
`
`controversy with respect to infringement of the ’393 patent.
`
`63.
`
`Upon information and belief, upon FDA approval of Watson’s ANDA, Watson’s
`
`commercial manufacture, use, sale offer for sale and/or importation into the United States of
`
`Watson’s ANDA Product will directly infringe one or more claims of the ’393 patent, and will
`
`indirectly infringe by actively inducing infringement by others, under 35 U.S.C. § 271(a), 35
`
`U.S.C. § 271(b), 35 U.S.C. § 271(c) and/or 35 U.S.C. § 271(g).
`
`64.
`
`Upon information and belief, Watson’s ANDA Products or an intermediate in its
`
`manufacture as described in and/or directed by Watson’s proposed labeling, ANDA, applicable
`
`DMF, and/or other corporate documents for Watson’s ANDA Product would infringe one or
`
`more claims of the ’393 patent.
`
`65.
`
`Upon information and belief, Watson will induce others to infringe one or more
`
`claims of the ’393 patent under 35 U.S.C. § 271(b) by, among other things, actively and
`
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`12
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`
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`knowingly aiding and abetting others to infringe, including, but not limited to the manufacturer
`
`of Watson’s ANDA Product, or its Active Pharmaceutical Ingredient (“API”), or other
`
`subsequent purchasers, distributors, or users thereof, which product or its manufacture
`
`constitutes direct infringement of one or more claims of the ’393 patent. Upon information and
`
`belief, Watson’s aiding and abetting includes Watson’s engagement of, contracting of, and/or
`
`encouragement of others to engage in the manufacture, use, sale, or importation of infringing
`
`products pursuant to Watson’s ANDA.
`
`66.
`
`Upon information and belief, Watson will also contributorily infringe one or more
`
`claims of the ’393 patent under 35 U.S.C. § 271(c) in that Watson will make, use, sell, offer to
`
`sell, and/or import its ANDA Product and/or the API thereof, which Watson knows has no
`
`substantial non-infringing uses. Upon information and belief, subsequent purchasers,
`
`distributors, or users thereof will also directly infringe one or more claims of the ’393 patent.
`
`67.
`
`Upon information and belief, Watson will also infringe one or more claims of the
`
`’393 patent under 35 U.S.C. § 271(g) by importing, selling, offering to sell or using Watson’s
`
`ANDA Product or the API or an intermediate thereof which is neither materially changed by
`
`subsequent process nor a trivial or non-essential component of another product.
`
`68.
`
`Upon information and belief, Watson was and is aware of the existence of the
`
`’393 patent and acted without a reasonable basis for believing that it would not be liable for
`
`infringement of the ’393 patent, thus rendering this case “exceptional” under 35 U.S.C. § 285.
`
`69.
`
`UTC will be substantially and irreparably damaged and harmed if Watson’s
`
`infringement of the ’393 patent is not enjoined by this Court. UTC does not have an adequate
`
`remedy at law.
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`70.
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`Upon information and belief, the acts of infringement by Watson will be
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`intentional and willful.
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`COUNT 5: INFRINGEMENT OF THE ’033 PATENT UNDER 35 U.S.C. § 271(e)
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`71.
`
`UTC repeats and realleges each of the foregoing paragraphs as if fully set forth
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`herein.
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`72.
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`Upon information and belief, use of Watson’s ANDA Product is covered by one
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`or more claims of the ’033 patent.
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`73. Watson had knowledge of the ’033 patent when it submitted ANDA No. 208172.
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`74. Watson’s submission of ANDA No. 208172 for the purpose of obtaining approval
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`to engage in the commercial manufacture, use, sale, and/or offer for sale of Watson’s ANDA
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`Product was an act of infringement of the ’033 patent under 35 U.S.C. § 271(e)(2).
`
`75.
`
`Upon information and belief, the commercial manufacture, use, offer for sale, sale
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`and/or importation of Watson’s ANDA Product would directly or indirectly infringe one or more
`
`claims of the ’033 patent.
`
`76.
`
`Upon information and belief, Watson will induce others to infringe one or more
`
`claims of the ’033 patent by, among other things, actively and knowingly aiding and abetting
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`others to infringe, including, but not limited to patients or health care providers that administer
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`Watson’s ANDA Product in diluted form for intravenous administration, which use constitutes
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`direct infringement of one or more claims of the ’033 patent. Upon information and belief,
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`Watson’s aiding and abetting includes Watson’s active steps to promote its ANDA Product for
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`infringing uses, and encourage and instruct such use as stated in, for example and without
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`limitation, proposed product package insert labeling pursuant to Watson’s ANDA.
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`77.
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`Upon information and belief, Watson was and is aware of the existence of the
`
`’033 patent and acted without a reasonable basis for believing that it would not be liable for
`
`infringement of the ’033 patent, thus rendering this case “exceptional” under 35 U.S.C. § 285.
`
`78.
`
`UTC will be substantially and irreparably damaged and harmed if Watson’s
`
`infringement of the ’033 patent is not enjoined by this Court. UTC does not have an adequate
`
`remedy at law.
`
`79.
`
`Upon information and belief, the acts of infringement by Watson have been
`
`intentional and willful.
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`COUNT 6: INFRINGEMENT OF THE ’033 PATENT UNDER 35 U.S.C. §§ 271(a) and (b)
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`80.
`
`UTC repeats and realleges each of the foregoing paragraphs as if fully set forth
`
`herein.
`
`81.
`
`Upon information and belief, upon FDA approval Watson will manufacture,
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`market, sell, offer to sell, import, and distribute Watson’s ANDA Product which will result in
`
`infringement of one or more claims of the ’033 patent.
`
`82. Watson’s ANDA and Watson’s intention to engage in the commercial
`
`manufacture, use, offer for sale, sale, or importation of Watson’s ANDA Product upon receiving
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`FDA approval prior to the expiration of the ’033 patent creates an actual and justiciable
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`controversy with respect to infringement of the ’033 patent.
`
`83.
`
`Upon information and belief, Watson will also induce others to infringe one or
`
`more claims of the ’033 patent under 35 U.S.C. § 271(b) by, among other things, actively and
`
`knowingly aiding and abetting others to infringe, including, but not limited to patients or health
`
`care providers that administer Watson’s ANDA Product for the treatment of pulmonary arterial
`
`hypertension, which use constitutes direct infringement of one or more claims of the ’033 patent.
`
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`
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`Upon information and belief, Watson’s aiding and abetting includes Watson’s active steps to
`
`promote its ANDA Product for infringing uses, and encourage and instruct such use as stated in,
`
`for example and without limitation, its proposed product package insert labeling pursuant to
`
`Watson’s ANDA.
`
`84.
`
`Upon information and belief, the use of Watson’s ANDA Product as described in
`
`and/or directed by Watson’s proposed labeling, ANDA, and/or other corporate documents for
`
`Watson’s ANDA Product would directly infringe one or more claims of the ’033 patent.
`
`85.
`
`Upon information and belief, upon FDA approval of Watson’s ANDA, Watson’s
`
`commercial manufacture, use, sale offer for sale and/or importation into the United States of
`
`Watson’s ANDA Product will infringe one or more claims of the ’033 patent, and by actively
`
`inducing infringement by others, under 35 U.S.C. § 271(a) and/or 35 U.S.C. § 271(b).
`
`86.
`
`Upon information and belief, Watson was and is aware of the existence of the
`
`’033 patent and acted without a reasonable basis for believing that it would not be liable for
`
`infringement of the ’033 patent, thus rendering this case “exceptional” under 35 U.S.C. § 285.
`
`87.
`
`UTC will be substantially and irreparably damaged and harmed if Watson’s
`
`infringement of the ’033 patent is not enjoined by this Court. UTC does not have an adequate
`
`remedy at law.
`
`88.
`
`Upon information and belief, the acts of infringement by Watson will be
`
`intentional and willful.
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`PRAYER FOR RELIEF
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`WHEREFORE, UTC requests the following relief:
`
`1.
`
`A judgment that Watson:
`
`A. has infringed the ’212 patent, the ’033 patent, and the ’393 patent;
`
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`B. will induce infringement of the ’212 patent, the ’033 patent, and the ’393
`
`patent, and
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`C. will contribute to the infringement by others of the ’212 patent, the ’033
`
`patent, and the ’393 patent;
`
`2.
`
`A judgment ordering that the effective date of any FDA approval for Watson to
`
`commercially manufacture, make, use, offer to sell, sell, market, or import into the United States
`
`Watson’s ANDA Product be not earlier than the latest of the expiration dates of the ’212 patent,
`
`the ’033 patent, and the ’393 patent, inclusive of any extension(s) and additional period(s) of
`
`exclusivity to which UTC is or may become entitled;
`
`3.
`
`A judgment pursuant to 35 U.S.C. § 271(e)(4)(B) preliminarily and permanently
`
`enjoining Watson, its officer, agents, servants, employees, parents, subsidiaries, affiliate
`
`corporations, other business entities and all other persons acting in concert, participation, or
`
`privity with them, their successors, and assigns, from infringing, contributorily infringing, or
`
`inducing others to infringe the ’212 patent, the ’033 patent, and/or the ’393 patent, including
`
`engaging in the commercial manufacture, use, sale, offer to sale and/or importation in the United
`
`States of the product that is the subject of ANDA No. 208172 and/or any applicable DMF until
`
`the expiration of the ’212 patent, the ’033 patent, and the ’393 patent, inclusive of any
`
`extension(s) and additional period(s) of exclusivity to which UTC is or may become entitled;
`
`4.
`
`A judgment declaring that making, using, selling, offering for sale, or importing
`
`into the United States of Watson’s ANDA Product, or any product or compound that infringes
`
`one or more of the ’212 patent, the ’033 patent, and/or the ’393 patent, prior to the expiration
`
`dates of the respective patents, will infringe, actively induce infringement of, and will contribute
`
`to the infringement by others of the ’212 patent, the ’033 patent, and the ’393 patent;
`
`
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`
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`5.
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`Temporary, preliminary, permanent, or other injunctive relief as necessary or
`
`appropriate should Watson seek to commercially manufacture, use, sell, offer to sell, or import
`
`Watson’s ANDA Product prior to disposition of this action and/or the expiration of the ’212
`
`patent, the ’033 patent, and the ’393 patent;
`
`6.
`
`A judgment awarding UTC damages or other monetary relief, pursuant to 35
`
`U.S.C. §§ 271(e)(4)(c) and 284, if Watson commercially manufactures, uses, sells, offers to sell
`
`and/or imports any product that is the subject of ANDA No. 208172 that infringes one or more of
`
`the ’212 patent, the ’033 patent, and/or the ’393 patent;
`
`7.
`
`8.
`
`9.
`
`A judgment declaring that Watson’s infringement has been willful;
`
`A judgement awarding UTC its actual damages for willful infringement;
`
`A judgment declaring that, pursuant to 35 U.S.C. § 285, this is an exceptional
`
`case and awarding UTC its attorney’s fees;
`
`10.
`
`Costs and expenses in this action; and
`
`11.
`
`Such further and other relief as this Court may deem just and proper.
`
`JURY DEMAND
`
`UTC requests trial by jury for any issues so triable.
`
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