Case 3:15-cv-05723-PGS-LHG Document 49 Filed 06/21/16 Page 1 of 17 PageID: 394
`
`
`
`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.: 3:15cv-05723-PGS-LHG
`)
`)
`)
`)
`)
`
`WATSON LABORATORIES, INC.,
`
`Defendant.
`
`FIRST AMENDED COMPLAINT AND JURY DEMAND
`
`Plaintiff United Therapeutics Corporation (“UTC”), by its undersigned attorneys, for its
`
`First Amended Complaint against Watson Laboratories, Inc. (“Watson”), alleges as follows:
`
`
`
`1
`
`
`
`
`
`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.: 3:15cv-05723-PGS-LHG
`)
`)
`)
`)
`)
`
`WATSON LABORATORIES, INC.,
`
`Defendant.
`
`FIRST AMENDED COMPLAINT AND JURY DEMAND
`
`Plaintiff United Therapeutics Corporation (“UTC”), by its undersigned attorneys, for its
`
`First Amended Complaint against Watson Laboratories, Inc. (“Watson”), alleges as follows:
`
`
`
`1
`
`
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`Case 3:15-cv-05723-PGS-LHG Document 49 Filed 06/21/16 Page 2 of 17 PageID: 395
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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
`
`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), 8,497,393 (“the ’393 patent”) (attached as Exhibit C hereto),
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`9,339,507 (“the ’507 patent”) (attached as Exhibit D hereto), and 9,358,240 (“the ’240 patent”)
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`(attached as Exhibit E hereto).
`
`2.
`
`This action arises out of Watson’s submission of Abbreviated New Drug
`
`Application (“ANDA”) No. 208172 to the United States Food and Drug Administration (“FDA”)
`
`seeking approval, prior to the expiration of the ’212, ’393, ’033, ’507, and ’240 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 FDA for treatment of pulmonary arterial hypertension.
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`THE PARTIES
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`3.
`
`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 biotechnology company focused on the development and commercialization of
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`products designed to address the needs of patients with chronic and life-threatening conditions.
`
`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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`2
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`Case 3:15-cv-05723-PGS-LHG Document 49 Filed 06/21/16 Page 3 of 17 PageID: 396
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`
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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 Watson
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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. 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
`
`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®.
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`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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`Case 3:15-cv-05723-PGS-LHG Document 49 Filed 06/21/16 Page 4 of 17 PageID: 397
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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.
`
`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
`
`United States Patent and Trademark Office on February 18, 2003. The named inventors are
`
`Gilles Cloutier, James Crow, Michael Wade, 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
`
`interest in and to the ’212 patent, including the right to bring infringement suits thereon.
`
`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. The named inventors are Hitesh Batra, Sudersan M. Tuladhar, Raju Penmasta,
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`and David A. Walsh.
`
`14.
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`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.
`
`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
`
`June 29, 2004. The named inventors are Gilles Cloutier, James Crow, Michael Wade, Richard E.
`
`Parker, and James E. Loyd.
`
`16.
`
`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.
`
`The ’507 patent, entitled “Treprostinil administration by inhalation,” was duly and
`
`legally issued by the United States Patent and Trademark Office on May 17, 2016. The named
`
`
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`4
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`
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`Case 3:15-cv-05723-PGS-LHG Document 49 Filed 06/21/16 Page 5 of 17 PageID: 398
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`
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`inventors are Horst Olschewski, Robert Roscingo, Lewis Rubin, Thomas Schmehl, Werner
`
`Seeger, Carl Sterritt, and Robert Voswinckel.
`
`18.
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`UTC is the lawful owner of the ’507 patent by assignment of all right, title, and
`
`interest in and to the ’507 patent, including the right to bring infringement suits thereon.
`
`19.
`
`The ’240 patent, entitled “Treprostinil administration by inhalation,” was duly and
`
`legally issued by the United States Patent and Trademark Office on June 7, 2016. The named
`
`inventors are Horst Olschewski, Robert Roscingo, Lewis Rubin, Thomas Schmehl, Werner
`
`Seeger, Carl Sterritt, and Robert Voswinckel.
`
`20.
`
`UTC is the lawful owner of the ’240 patent by assignment of all right, title, and
`
`interest in the ‘240 patent, including the right to bring infringement suits thereon.
`
`21.
`
`TYVASO® and its FDA approved manufacture and uses are covered by one or
`
`more claims of the ’212, ’033, ’393, ’507, and ’240 patents, which have all been listed in
`
`connection with TYVASO® in the FDA’s Approved 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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`22. Watson notified UTC by letter dated June 12, 2015, which was delivered to UTC
`
`on or about, Saturday, June 13, 2015 (“Watson’s Notice Letter”), that it had filed ANDA No.
`
`208172 with the FDA seeking approval to commercially manufacture, market, use, and sell
`
`generic copies of TYVASO® (treprostinil) Inhalation Solution, 0.6 mg/mL (“Watson’s ANDA
`
`Products”) prior to the expiration of the ’212, ’033, and ’393 patents.
`
`23. Watson’s Notice Letter included a statement pursuant to 21 U.S.C. §
`
`355(j)(2)(vii)(IV) purporting to recite Watson’s “factual and legal basis” for its opinion that the
`
`’212, ’033, and ’393 patents are not valid, are unenforceable, and/or would not be infringed by
`
`
`
`5
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`Case 3:15-cv-05723-PGS-LHG Document 49 Filed 06/21/16 Page 6 of 17 PageID: 399
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`
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`the commercial manufacture, use, or sale of Watson’s ANDA Products. Yet that statement did
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`not include any explanation as to why claims 1-5 and 9-12 of the ’212 patent, claims 4 and 6-10
`
`of the ’033 patent, and any claim of the ’393 patent were invalid. The statement also did not
`
`include anything beyond conclusory statements as to why claims 6-8 of the ’212 patent and
`
`claims 1-3 and 5 of the ’033 patent were invalid. The statement also did not include anything
`
`beyond conclusory statements regarding alleged non-infringement. Watson provided no
`
`explanation as to the alleged unenforceability.
`
`24.
`
`Upon information and belief, Watson submitted ANDA No. 208172 with FDA
`
`seeking approval to commercially manufacture, market, use, and sell generic copies of
`
`TYVASO® (treprostinil) Inhalation Solution, 0.6 mg/mL (“Watson’s ANDA Products”) prior to
`
`the expiration of the ’212, ’033, ’393,’507, and ’240 patents.
`
`25.
`
`UTC commenced this action before the expiration of forty-five days from the date
`
`UTC received Watson’s Notice Letter.
`
`26.
`
`Upon information and belief, Watson’s ANDA Products contains the same active
`
`compound as UTC’s approved TYVASO® product.
`
`27.
`
`Upon information and belief, Watson’s ANDA No. 208172 seeks approval from
`
`the FDA to market Watson’s ANDA Products for the same indication as UTC’s approved
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`TYVASO® product.
`
`28.
`
`Upon information and belief, Watson represented to FDA in ANDA No. 208172
`
`that Watson’s ANDA Products is bioequivalent to UTC’s approved TYVASO® product.
`
`29.
`
`Upon information and belief, Watson intends to commercially manufacture, sell,
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`offer for sale, and/or import Watson’s ANDA Products upon, or in anticipation of, FDA
`
`approval.
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`6
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`Case 3:15-cv-05723-PGS-LHG Document 49 Filed 06/21/16 Page 7 of 17 PageID: 400
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`30.
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`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
`
`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 Products.
`
`31.
`
`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. §§
`
`355(j)(2)(B)(iv)(II) and 21 C.F.R. § 314.95(c)(6).
`
`32.
`
`Upon information and belief, the acts of infringement by Watson have been
`
`intentional and willful.
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`COUNT 1 INFRINGEMENT OF THE ’212 PATENT UNDER 35 U.S.C. § 271(e)
`
`33.
`
`UTC repeats and realleges each of the foregoing paragraphs as if fully set forth
`
`herein.
`
`34.
`
`Upon information and belief, Watson’s ANDA Products 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
`
`to engage in the commercial manufacture, use, sale, and/or offer for sale of Watson’s ANDA
`
`Products was an act of infringement of the ’212 patent under 35 U.S.C. § 271(e)(2).
`
`37.
`
`Upon information and belief, the commercial manufacture, use, offer for sale, sale
`
`and/or importation of Watson’s ANDA Products would infringe one or more claims of the ’212
`
`patent.
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`7
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`Case 3:15-cv-05723-PGS-LHG Document 49 Filed 06/21/16 Page 8 of 17 PageID: 401
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`38.
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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.
`
`39.
`
`UTC will be substantially and irreparably damaged and harmed if Watson’s
`
`infringement of the ’212 patent is not enjoined by this Court. UTC does not have an adequate
`
`remedy at law.
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`40.
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`Upon information and belief, the acts of infringement by Watson have been
`
`intentional and willful.
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`COUNT 2: INFRINGEMENT OF THE ’393 PATENT UNDER 35 U.S.C. § 271(e)
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`41.
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`UTC repeats and realleges each of the foregoing paragraphs as if fully set forth
`
`herein.
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`42.
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`Upon information and belief, Watson’s ANDA Products or an intermediate in its
`
`manufacture is covered by one or more claims of the ’393 patent.
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`43. Watson had knowledge of the ’393 patent when it submitted ANDA No. 208172.
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`44. 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
`
`Products was an act of infringement of the ’393 patent under 35 U.S.C. § 271(e)(2).
`
`45.
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`Upon information and belief, the commercial manufacture, use, offer for sale, sale
`
`and/or importation of Watson’s ANDA Products would infringe one or more claims of the ’393
`
`patent.
`
`46.
`
`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.
`
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`8
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`Case 3:15-cv-05723-PGS-LHG Document 49 Filed 06/21/16 Page 9 of 17 PageID: 402
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`47.
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`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.
`
`48.
`
`Upon information and belief, the acts of infringement by Watson have been
`
`intentional and willful.
`
`COUNT 3: INFRINGEMENT OF THE ’033 PATENT UNDER 35 U.S.C. § 271(e)
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`49.
`
`UTC repeats and realleges each of the foregoing paragraphs as if fully set forth
`
`herein.
`
`50.
`
`Upon information and belief, use of Watson’s ANDA Products is covered by one
`
`or more claims of the ’033 patent.
`
`51. Watson had knowledge of the ’033 patent when it submitted ANDA No. 208172.
`
`52. 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
`
`Products was an act of infringement of the ’033 patent under 35 U.S.C. § 271(e)(2).
`
`53.
`
`Upon information and belief, the commercial manufacture, use, offer for sale, sale
`
`and/or importation of Watson’s ANDA Products would directly or indirectly infringe one or
`
`more claims of the ’033 patent.
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`54.
`
`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
`
`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,
`
`Watson’s aiding and abetting includes Watson’s active steps to promote its ANDA Product for
`
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`9
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`Case 3:15-cv-05723-PGS-LHG Document 49 Filed 06/21/16 Page 10 of 17 PageID: 403
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`
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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.
`
`55.
`
`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.
`
`56.
`
`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.
`
`57.
`
`Upon information and belief, the acts of infringement by Watson have been
`
`intentional and willful.
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`COUNT 4: INFRINGEMENT OF THE ’507 PATENT UNDER 35 U.S.C. § 271(e)
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`58.
`
`UTC repeats and realleges each of the foregoing paragraphs as if fully set forth
`
`herein.
`
`59.
`
`Upon information and belief, use of Watson’s ANDA Products is covered by one
`
`or more claims of the ’507 patent.
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`60. 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
`
`Products was an act of infringement of the ’507 patent under 35 U.S.C. § 271(e)(2).
`
`61.
`
`Upon information and belief, the commercial manufacture, use, offer for sale, sale
`
`and/or importation of Watson’s ANDA Products would directly or indirectly infringe one or
`
`more claims of the ’507 patent.
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`62.
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`Upon information and belief, Watson will induce others to infringe one or more
`
`claims of the ’507 patent by, among other things, actively and knowingly aiding and abetting
`
`
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`10
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`Case 3:15-cv-05723-PGS-LHG Document 49 Filed 06/21/16 Page 11 of 17 PageID: 404
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`
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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 by inhalation, which use constitutes direct infringement of one or more
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`claims of the ’507 patent. 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, proposed product package
`
`insert labeling pursuant to Watson’s ANDA.
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`63.
`
`Upon information and belief, Watson was and is aware of the existence of the
`
`’507 patent and lacks a reasonable basis for believing that it would not be liable for infringement
`
`of the ’507 patent, thus rendering this case “exceptional” under 35 U.S.C. § 285.
`
`64.
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`UTC will be substantially and irreparably damaged and harmed if Watson’s
`
`infringement of the ’507 patent is not enjoined by this Court. UTC does not have an adequate
`
`remedy at law.
`
`65.
`
`Upon information and belief, the acts of infringement by Watson have been
`
`intentional and willful.
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`COUNT 5: INFRINGEMENT OF THE ’507 PATENT UNDER 35 U.S.C. § 271(e)
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`66.
`
`UTC repeats and realleges each of the foregoing paragraphs as if fully set forth
`
`herein.
`
`67.
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`Upon information and belief, use of Watson’s ANDA Products is covered by one
`
`or more claims of the ’240 patent.
`
`68. 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
`
`Products was an act of infringement of the ’240 patent under 35 U.S.C. § 271(e)(2).
`
`
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`11
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`Case 3:15-cv-05723-PGS-LHG Document 49 Filed 06/21/16 Page 12 of 17 PageID: 405
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`69.
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`Upon information and belief, the commercial manufacture, use, offer for sale, sale
`
`and/or importation of Watson’s ANDA Products would directly or indirectly infringe one or
`
`more claims of the ’240 patent.
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`70.
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`Upon information and belief, Watson will induce others to infringe one or more
`
`claims of the ’240 patent 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 by inhalation, which use constitutes direct infringement of one or more
`
`claims of the ’240 patent. 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, proposed product package
`
`insert labeling pursuant to Watson’s ANDA.
`
`71.
`
`Upon information and belief, Watson was and is aware of the existence of the
`
`’240 patent and lacks a reasonable basis for believing that it would not be liable for infringement
`
`of the ’240 patent, thus rendering this case “exceptional” under 35 U.S.C. § 285.
`
`72.
`
`UTC will be substantially and irreparably damaged and harmed if Watson’s
`
`infringement of the ’240 patent is not enjoined by this Court. UTC does not have an adequate
`
`remedy at law.
`
`73.
`
`Upon information and belief, the acts of infringement by Watson have been
`
`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:
`
`
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`12
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`Case 3:15-cv-05723-PGS-LHG Document 49 Filed 06/21/16 Page 13 of 17 PageID: 406
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`A. has infringed the ’212 patent, the ’033 patent, the ’393 patent, the ’507 patent,
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`and the ’240 patent;
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`B. will induce infringement of the ’212 patent, the ’033 patent, the ’393 patent,
`
`the ’507 patent, and the ’240 patent, and
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`C. will contribute to the infringement by others of the ’212 patent, the ’033
`
`patent, the ’393 patent, the ’507 patent, and the ’240 patent;
`
`2.
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`A judgment ordering that the effective date of any FDA approval for Watson to
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`commercially manufacture, make, use, offer to sell, sell, market, or import into the United States
`
`Watson’s ANDA Products be not earlier than the latest of the expiration dates of the ’212 patent,
`
`the ’033 patent, the ’393 patent, the ’507 patent, and the ’240 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, the ’393 patent, the ’507 patent,
`
`and/or the ’240 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, the ’393
`
`patent, the ’507 patent, and the ’240 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 Products, or any product or compound that infringes
`
`
`
`13
`
`
`
`Case 3:15-cv-05723-PGS-LHG Document 49 Filed 06/21/16 Page 14 of 17 PageID: 407
`
`
`
`one or more of the ’212 patent, the ’033 patent, the ’393 patent, the ’507 patent, and/or the ’240
`
`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, the ’393 patent, the ’507 patent, and the ’240 patent;
`
`5.
`
`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 Products prior to disposition of this action and/or the expiration of the ’212
`
`patent, the ’033 patent, the ’393 patent, the ’507 patent, and the ’240 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, the ’393 patent, the ’507 patent, and/or the ’240 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.
`
`
`
`
`
`
`14
`
`
`
`Case 3:15-cv-05723-PGS-LHG Document 49 Filed 06/21/16 Page 15 of 17 PageID: 408
`
`Respectfully submitted,
`
`
`s/ William J. O’Shaughnessy
`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
`
`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 Avenue, NW
`Washington, DC 20015
`
`Attorneys for Plaintiff
`Dated: June 21, 2016
` United Therapeutics Corporation
`
`
`
`15
`
`
`
`Case 3:15-cv-05723-PGS-LHG Document 49 Filed 06/21/16 Page 16 of 17 PageID: 409
`
`
`
`LOCAL CIVIL RULE 11.2 CERTIFICATION
`
`UTC hereby certifies that, to its knowledge, the matter in controversy in this action is not
`
`the subject of any other pending lawsuit, arbitration, or administrative proceeding other than the
`
`following identified proceedings:
`
` Supernus Pharmaceuticals, Inc. v. Hon. Michelle K. Lee, Civil Action No. 16-cv-
`342 (GBL)(IDD) (E.D. Va.); and
`
`
`
` United Therapeutics Corporation v. Actavis Laboratories FL, Inc., Civil Action
`No. 3:16-cv-1816 (PGS)(LHG) (D.N.J.).
`
`
`
`
`
`
`
`Respectfully submitted,
`
`s/ William J. O’Shaughnessy
`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
`
`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 Avenue, NW
`Washington, DC 20015
`
`
`
`Attorneys for Plaintiff
`Dated: June 21, 2016
` United Therapeutics Corporation
`
`
`
`
`
`
`16
`
`
`
`Case 3:15-cv-05723-PGS-LHG Document 49 Filed 06/21/16 Page 17 of 17 PageID: 410
`
`
`
`
`
`CERTIFICATE OF SERVICE
`
`I certify that on this day I caused to be served by the ECF system copies of the First
`
`Amended Complaint upon the following:
`
`Walsh Pizzi O’Reilly Falanga LLP
`Liza M. Walsh
`Tricia B. O’Reilly
`Joseph L. Linares
`One Newark Center
`1085 Raymond Boulevard, 6th Floor
`Newark, NJ 07102
`(973) 757-1100
`
`OF COUNSEL:
`
`WINSTON STRAWN LLP
`Michael K. Nutter
`Kurt A. Mathas
`35 West Wacker Drive
`Chicago, Illinois 60601
`Tel: (312) 558-5600
`Fax: (312) 558-5700
`
`
`
`
`
`
`
`
`
`Dated: June 21, 2016
`
`
`
`
`
`
`
`
`
`s/ William J. O’Shaughnessy
`William J. O’Shaughnessy
`
`
`
`
`
`17
`
`
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