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`UNITED THERAPEUTICS
`CORPORATION and
`SUPERNUS PHARMACEUTICALS, INC.,
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`Plaintiffs,
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`v.
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`C.A. No. ________________
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
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`
`COMPLAINT
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`ANI PHARMACEUTICALS, INC.,
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`
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`
`
`
`Defendant.
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`Plaintiffs United Therapeutics Corporation (“UTC”) and Supernus Pharmaceuticals, Inc.
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`(“Supernus”) (collectively, “Plaintiffs”), by their undersigned attorneys, for their Complaint
`
`against ANI Pharmaceuticals, Inc. (“ANI”), allege as follows:
`
`NATURE OF THE ACTION
`
`1.
`
`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 Nos.
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`7,417,070 (“the ’070 patent”) (attached as Exhibit A hereto), 7,544,713 (“the ’713 patent”)
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`(attached as Exhibit B hereto), 8,252,839 (“the ’839 patent”) (attached as Exhibit C hereto),
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`8,349,892 (“the ’892 patent”) (attached as Exhibit D hereto), 8,410,169 (“the ’169 patent”)
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`(attached as Exhibit E hereto), 8,747,897 (“the ’897 patent”) (attached as Exhibit F hereto),
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`9,050,311 (“the ’311 patent”) (attached as Exhibit G hereto), 9,278,901 (“the ’901 patent”)
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`(attached as Exhibit H hereto), 9,393,203 (“the ’203 patent”) (attached as Exhibit I hereto),
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`9,422,223 (“the ’223 patent”) (attached as Exhibit J hereto), 9,593,066 (“the ’066 patent”)
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`(attached as Exhibit K hereto), and 9,604,901 (“the ’4901 patent”) (attached as Exhibit L hereto).
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`
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`
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`Case 1:21-cv-00489-UNA Document 1 Filed 04/01/21 Page 2 of 38 PageID #: 2
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`
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`2.
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`This action arises out of ANI’s submission of Abbreviated New Drug Application
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`(“ANDA”) No. 215667 (“ANI’s ANDA”) to the United States Food and Drug Administration
`
`(“FDA”) seeking approval, prior to the expiration of the ’070, ’713, ’839, ’892, ’169, ’897, ’311,
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`’901, ’203, ’223, ’066, and ’4901 patents, to manufacture, market, and sell generic copies of UTC’s
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`ORENITRAM® (treprostinil) Extended-Release Tablets, which are approved by FDA for
`
`treatment of pulmonary arterial hypertension.
`
`THE PARTIES
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`3.
`
`UTC is a corporation organized and existing under the laws of the State of Delaware
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`having a place of business at 1040 Spring Street, Silver Spring, Maryland 20910. UTC is a
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`pharmaceutical and biotechnology company focused on the development and commercialization
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`of products designed to address the needs of patients with chronic and life-threatening conditions.
`
`4.
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`Supernus is a corporation organized and existing under the laws of the State of
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`Delaware having a place of business at 9715 Key West Avenue, Rockville, MD 20850. Supernus
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`is a specialty pharmaceutical company focused on developing and commercializing products for
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`the treatment of central nervous system (CNS) disorders.
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`5.
`
`Upon information and belief, ANI is a corporation organized and existing under the
`
`laws of the State of Delaware having a principal place of business at 210 Main Street West,
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`Baudette, MN 56623.
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`JURISDICTION AND VENUE
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`6.
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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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`7.
`
`This Court has personal jurisdiction over ANI because, upon information and
`
`belief, ANI is incorporated and resides in Delaware.
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`2
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`Case 1:21-cv-00489-UNA Document 1 Filed 04/01/21 Page 3 of 38 PageID #: 3
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`
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`8.
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`Venue is proper in this Court under 28 U.S.C. § 1400(b).
`
`BACKGROUND
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`9.
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`UTC holds an approved New Drug Application (No. 203496) for treprostinil
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`extended-release
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`tablets
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`that UTC markets and sells under
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`the registered
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`trademark
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`ORENITRAM®.
`
`10.
`
`ORENITRAM® is a pharmaceutical product initially approved by FDA in
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`December 2013, and is indicated for the treatment of pulmonary arterial hypertension. Pulmonary
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`arterial hypertension is a rare disease affecting the pulmonary vasculature and results in increased
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`pressure in the pulmonary arteries, which increases strain on the heart, which, in turn, can lead to
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`heart failure and death.
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`11.
`
`ORENITRAM® is an extended-release tablet available in four dosage strengths,
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`0.125 mg, 0.25 mg, 1 mg, and 2.5 mg. ORENITRAM® is designed to release treprostinil using an
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`osmotic tablet technology.
`
`12.
`
`The ’070 patent, entitled “Compounds and methods for delivery of prostacyclin
`
`analogs,” was duly and legally issued by the United States Patent and Trademark Office on
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`August 26, 2008. The named inventors are Ken Phares and David Mottola.
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`13.
`
`UTC is the lawful owner of the ’070 patent by assignment of all right, title and
`
`interest in and to the ’070 patent, including the right to sue for infringement thereof.
`
`14.
`
`The ’713 patent, entitled “Compounds and methods for delivery of prostacyclin
`
`analogs,” was duly and legally issued by the United States Patent and Trademark Office on June
`
`9, 2009. The named inventors are Ken Phares and David Mottola.
`
`15.
`
`UTC is the lawful owner of the ’713 patent by assignment of all right, title and
`
`interest in and to the ’713 patent, including the right to sue for infringement thereof.
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`3
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`Case 1:21-cv-00489-UNA Document 1 Filed 04/01/21 Page 4 of 38 PageID #: 4
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`
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`16.
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`The ’839 patent, entitled “Compounds and methods for delivery of prostacyclin
`
`analogs,” was duly and legally issued by the United States Patent and Trademark Office on
`
`August 28, 2012. The named inventors are Ken Phares and David Mottola.
`
`17.
`
`UTC is the lawful owner of the ’839 patent by assignment of all right, title and
`
`interest in and to the ’839 patent, including the right to sue for infringement thereof.
`
`18.
`
`The ’892 patent, entitled “Solid formulations of prostacyclin analogs” was duly and
`
`legally issued by the United States Patent and Trademark Office on January 8, 2013. The named
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`inventor is Kenneth R. Phares.
`
`19.
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`UTC is the lawful owner of the ’892 patent by assignment of all right, title and
`
`interest in and to the ’892 patent, including the right to sue for infringement thereof.
`
`20.
`
`The ’169 patent, entitled “Compounds and methods for delivery of prostacyclin
`
`analogs,” was duly and legally issued by the United States Patent and Trademark Office on April
`
`2, 2013. The named inventors are Ken Phares and David Mottola.
`
`21.
`
`UTC is the lawful owner of the ’169 patent by assignment of all right, title and
`
`interest in and to the ’169 patent, including the right to sue for infringement thereof.
`
`22.
`
`The ’897 patent, entitled “Osmotic drug delivery system,” was duly and legally
`
`issued by the United States Patent and Trademark Office on June 10, 2014. The named inventors
`
`are Argaw Kidane and Padmanabh P. Bhatt.
`
`23.
`
`Supernus is the lawful owner of the ’897 patent by assignment of all right, title and
`
`interest in and to the ’897 patent, including the right to sue for infringement thereof. UTC is the
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`exclusive licensee of the ’897 patent, with the exclusive right to develop, make, have made, use,
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`offer for sale, sell, have sold, and import products covered by the ’897 patent.
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`4
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`Case 1:21-cv-00489-UNA Document 1 Filed 04/01/21 Page 5 of 38 PageID #: 5
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`
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`24.
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`The ’311 patent, entitled “Compounds and methods for delivery of prostacyclin
`
`analogs,” was duly and legally issued by the United States Patent and Trademark Office on June 9,
`
`2015. The named inventors are Ken Phares, David Mottola, and Hitesh Batra.
`
`25.
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`UTC is the lawful owner of the ’311 patent by assignment of all right, title and
`
`interest in and to the ’311 patent, including the right to sue for infringement thereof.
`
`26.
`
`The ’901 patent, entitled “Compounds and methods for delivery of prostacyclin
`
`analogs,” was duly and legally issued by the United States Patent and Trademark Office on March
`
`8, 2016. The named inventors are Ken Phares, David Mottola, and Roger Jeffs.
`
`27.
`
`UTC is the lawful owner of the ’901 patent by assignment of all right, title and
`
`interest in and to the ’901 patent, including the right to sue for infringement thereof.
`
`28.
`
`The ’203 patent, entitled “Osmotic drug delivery system,” was duly and legally
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`issued by the United States Patent and Trademark Office on July 19, 2016. The named inventors
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`are Argaw Kidane and Padmanabh P. Bhatt.
`
`29.
`
`Supernus is the lawful owner of the ’203 patent assignment of all right, title and
`
`interest in and to the ’203 patent, including the right to sue for infringement thereof. UTC is the
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`exclusive licensee of the ’203 patent, with the exclusive right to develop, make, have made, use,
`
`offer for sale, sell, have sold, and import products covered by the ’203 patent.
`
`30.
`
`The ’223 patent, entitled “Compounds and methods for delivery of prostacyclin
`
`analogs,” was duly and legally issued by the United States Patent and Trademark Office on August
`
`23, 2016. The named inventors are Ken Phares, David Mottola, and Roger Jeffs.
`
`31.
`
`UTC is the lawful owner of the ’223 patent assignment of all right, title and interest
`
`in and to the ’223 patent, including the right to sue for infringement thereof.
`
`5
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`Case 1:21-cv-00489-UNA Document 1 Filed 04/01/21 Page 6 of 38 PageID #: 6
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`
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`32.
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`The ’066 patent, entitled “Process to prepare treprostinil, the active ingredient in
`
`Remodulin®,” was duly and legally issued by the United States Patent and Trademark Office on
`
`March 14, 2017. The named inventors are Hitesh Batra, Sudersan M. Tuladhar, Raju Penmasta,
`
`and David A. Walsh.
`
`33.
`
`UTC is the lawful owner of the ’066 patent assignment of all right, title and interest
`
`in and to the ’066 patent, including the right to sue for infringement thereof.
`
`34.
`
`The ’4901 patent, entitled “Process to prepare treprostinil, the active ingredient in
`
`Remodulin®,” was duly and legally issued by the United States Patent and Trademark Office on
`
`March 28, 2017. The named inventors are Hitesh Batra, Sudersan M. Tuladhar, Raju Penmasta,
`
`and David A. Walsh.
`
`35.
`
`UTC is the lawful owner of the ’4901 patent assignment of all right, title and interest
`
`in and to the ’4901 patent, including the right to sue for infringement thereof.
`
`36.
`
`ORENITRAM® and its FDA-approved uses are covered by one or more claims of
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`the ’070, ’713, ’839, ’892, ’169, ’897, ’311, ’901, ’203, ’223, ’066, and ’4901 patents, which have
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`been listed in connection with ORENITRAM® in 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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`37.
`
`ANI notified Plaintiffs by letter dated February 19, 2021, which was delivered to
`
`Plaintiffs on or about February 23, 2021 (“ANI’s Notice Letter”), that it had submitted ANDA No.
`
`215667 (“ANI’s ANDA”) to the FDA, seeking approval to commercially manufacture, market, use,
`
`and sell generic copies of ORENITRAM® (treprostinil) Extended-Release Tablets, 2.5 mg (“ANI’s
`
`ANDA Product”) prior to the expiration of the ’070, ’713, ’839, ’892, ’169, ’897, ’311, ’901, ’203,
`
`’223, ’066 and ’4901 patents.
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`6
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`Case 1:21-cv-00489-UNA Document 1 Filed 04/01/21 Page 7 of 38 PageID #: 7
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`
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`38.
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`Upon information and belief, ANI submitted ANI’s ANDA to the FDA seeking
`
`approval to commercially manufacture, market, use, and sell ANI’s ANDA Product prior to the
`
`expiration of the ’070, ’713, ’839, ’892, ’169, ’897,’311, ’901, ’203, ’223, ’066 and ’4901 patents.
`
`39.
`
`ANI’s Notice Letter included a statement under 21 U.S.C. § 355(j)(2)(vii)(IV)
`
`purporting to set forth ANI’s “factual and legal bases” for its opinion that the ’070, ’713, ’839,
`
`’892, ’169, ’897, ’311, ’901, ’203, ’223, ’066 and ’4901 patents are “invalid, unenforceable, and/or
`
`not infringed” by the commercial manufacture, use, or sale of ANI’s ANDA Product. That
`
`statement did not include any contention that any claim of the ’070 patent, claims 23-25 of the ’713
`
`patent, claims 1 and 3-5 of the ’839 patent, claims 8 and 9 of the ’169 patent, claims 1, 5, 6, and 10
`
`of the ’311 patent, or any claim of the ’223 patent are not infringed. That statement also did not
`
`include any contention that claims 1-22 and 26 of the ’713 patent, claim 2 of the ’839 patent, any
`
`claim of the ’892 patent, claims 1-7 and 10-11 of the ’169 patent, claims 2-4 and 7-9 of the ’311
`
`patent, claim 12 of the ’901 patent, or any claim of the ’203 patent are invalid. ANI did not allege
`
`the unenforceability of any claim except claims 1-5 of the ’839 patent and claims 8-9 of the ’169
`
`patent.
`
`40.
`
`Plaintiffs are commencing this action before the expiration of forty-five days from
`
`the date Plaintiffs received ANI’s Notice Letter.
`
`41.
`
`Upon information and belief, ANI’s ANDA Product contains the same active
`
`compound as UTC’s approved ORENITRAM® product.
`
`42.
`
`Upon information and belief, the active pharmaceutical ingredient (“API”) of
`
`ANI’s ANDA Product is treprostinil diethanolamine, which has the following structure:
`
`7
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`Case 1:21-cv-00489-UNA Document 1 Filed 04/01/21 Page 8 of 38 PageID #: 8
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`
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`Upon information and belief, ANI’s ANDA seeks approval from the FDA to market
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`43.
`
`ANI’s ANDA Product for the same indication as UTC’s approved ORENITRAM® product.
`
`44.
`
`Upon information and belief, ANI represented to the FDA in ANI’s ANDA that
`
`ANI’s ANDA Product is bioequivalent to UTC’s approved ORENITRAM® product.
`
`45.
`
`Upon information and belief, ANI intends to commercially manufacture, use, sell,
`
`offer for sale, and/or import ANI’s ANDA Product upon, or in anticipation of, FDA approval.
`
`46.
`
`According to ANI’s Notice Letter, ANI’s ANDA contained a “Paragraph IV”
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`certification pursuant to 21 U.S.C. § 355(j)(2)(vii)(IV) stating that in ANI’s opinion, the ’070, ’713,
`
`’839, ’892, ’169, ’897, ’311, ’901, ’203, ’223, ’066 and ’4901 patents are invalid, unenforceable,
`
`and/or would not be infringed by the commercial manufacture, use or sale of ANI’s ANDA
`
`Product.
`
`47.
`
`Upon information and belief, as of the date of ANI’s Notice Letter, ANI was aware
`
`of the statutory provisions and regulations set forth in 21 U.S.C. §§ 355(j)(2)(B)(iv)(II) and
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`21 C.F.R. § 314.95(c)(6).
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`8
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`Case 1:21-cv-00489-UNA Document 1 Filed 04/01/21 Page 9 of 38 PageID #: 9
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`
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`C.
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`48.
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`Upon information and belief, the API of ANI’s ANDA Product melts at about 107°
`
`49.
`
`Upon information and belief, the API of ANI’s ANDA Product has an x-ray powder
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`diffraction pattern having a pattern peak at about 17.2 degrees 2 theta.
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`50.
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`Upon information and belief, the API of ANI’s ANDA Product comprises a
`
`diethanolamine salt of (+)-treprostinil.
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`51.
`
`Upon information and belief, the API of ANI’s ANDA Product comprises a
`
`polymorph of a diethanolamine salt of (+)-treprostinil, which polymorph melts at 107° C.
`
`52.
`
`Upon information and belief, ANI’s ANDA product is a pharmaceutical
`
`formulation comprising a therapeutically effective amount of a diethanolamine salt of treprostinil
`
`and a pharmaceutically acceptable carrier.
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`53.
`
`54.
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`Upon information and belief, ANI’s ANDA product is formulated as a tablet.
`
`Upon information and belief, ANI’s ANDA product provides an oral bioavailability
`
`of treprostinil at least 50% greater than the oral bioavailability of a composition with treprostinil
`
`as a free acid.
`
`55.
`
`Upon information and belief, ANI’s ANDA product provides an oral bioavailability
`
`of treprostinil at least 100% greater than the oral bioavailability of a composition with treprostinil
`
`as a free acid.
`
`56.
`
`Upon information and belief, the API of ANI’s ANDA product is prepared by a
`
`method comprising dissolving treprostinil in a solvent, adding diethanolamine, heating, and
`
`cooling in an antisolvent to form the diethanolamine salt of treprostinil as a crystalline solid.
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`57.
`
`Upon information and belief, ANI’s ANDA Product has an absolute bioavailability
`
`of at least 15%.
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`9
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`Case 1:21-cv-00489-UNA Document 1 Filed 04/01/21 Page 10 of 38 PageID #: 10
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`
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`58.
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`Upon information and belief, ANI’s ANDA Product has an absolute bioavailability
`
`of between 21% and 25%.
`
`59.
`
`Upon information and belief, ANI’s ANDA Product, if used as described in ANI’s
`
`proposed labelling, results in a Cmax in the plasma of the person to whom it is administered that
`
`increases in a linear fashion over 8 hours.
`
`60.
`
`Upon information and belief, ANI’s ANDA Product, if used as described in ANI’s
`
`proposed labelling, results in a AUCinf in the plasma of the person to whom it is administered that
`
`increases in a linear fashion over 8 hours.
`
`61.
`
`Upon information and belief, ANI’s ANDA Product, if used as described in ANI’s
`
`proposed labelling, results in a concentration of treprostinil in the person’s plasma of at least
`
`50 pg/ml for at least 8 hours.
`
`COUNT 1: INFRINGEMENT OF THE ’070 PATENT
`UNDER 35 U.S.C. §§ 271(a)-(c), (e) and (g)
`
`62.
`
`Plaintiffs repeat and reallege each of the foregoing paragraphs as if fully set forth
`
`herein.
`
`63.
`
`Upon information and belief, upon FDA approval, ANI will manufacture, market,
`
`sell, offer to sell, import, and distribute ANI’s ANDA Products, which will result in infringement
`
`of one or more claims of the ’070 patent.
`
`64.
`
`ANI’s submission of ANI’s ANDA and its intention to engage in the commercial
`
`manufacture, use, sale, offer for sale, or importation of ANI’s ANDA Product upon receiving FDA
`
`approval prior to the expiration of the ’070 patent creates an actual and justiciable controversy
`
`with respect to infringement of the ’070 patent.
`
`65.
`
`Upon information and belief, ANI’s submission of ANI’s ANDA and, upon FDA
`
`approval of ANI’s ANDA, ANI’s commercial manufacture, use, sale, offer for sale, and/or
`
`10
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`
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`Case 1:21-cv-00489-UNA Document 1 Filed 04/01/21 Page 11 of 38 PageID #: 11
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`
`
`importation into the United States of ANI’s ANDA Product has infringed and will directly infringe
`
`one or more claims of the ’070 patent, and will indirectly infringe by actively inducing
`
`infringement by others, under one or more of 35 U.S.C. § 271(a), 35 U.S.C. § 271(b), 35 U.S.C.
`
`§ 271(c), 35 U.S.C. § 271(e), and/or 35 U.S.C. § 271(g).
`
`66.
`
`ANI’s submission of ANI’s ANDA for the purpose of obtaining approval to engage
`
`in the commercial manufacture, use, sale, and/or offer for sale of ANI’s ANDA Product prior to
`
`expiration of the ’070 patent was an act of infringement of the ’070 patent under 35 U.S.C.
`
`§ 271(e)(2).
`
`67.
`
`Upon information and belief, ANI’s ANDA Product or an intermediate in its
`
`manufacture as described in and/or directed by ANI’s proposed labeling, ANDA, applicable DMF,
`
`and/or other corporate documents for ANI’s ANDA Product would infringe one or more claims of
`
`the ’070 patent.
`
`68.
`
`Upon information and belief, ANI will induce others to infringe one or more claims
`
`of the ’070 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, the manufacturer of ANI’s ANDA
`
`Product, or its API or subsequent purchasers, distributors, or users thereof, which product or its
`
`use constitutes direct infringement of one or more claims of the ’070 patent. Upon information
`
`and belief, ANI’s aiding and abetting includes ANI’s engagement of, contracting of, and/or
`
`encouragement of others to engage in the manufacture, use, sale, or importation of infringing
`
`products pursuant to ANI’s ANDA. ANI will do so with knowledge of the ’070 patent and intent
`
`to induce the infringement thereof.
`
`69.
`
`Upon information and belief, ANI will also contributorily infringe one or more
`
`claims of the ’070 patent under 35 U.S.C. § 271(c) in that ANI will make, use, sell, offer to sell,
`
`11
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`Case 1:21-cv-00489-UNA Document 1 Filed 04/01/21 Page 12 of 38 PageID #: 12
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`
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`and/or import its ANDA Product and/or the API thereof, which ANI 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 ’070 patent.
`
`70.
`
`Upon information and belief, ANI will also infringe one or more claims of the ’070
`
`patent under 35 U.S.C. § 271(g) by importing, selling, offering to sell, or using ANI’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.
`
`71.
`
`Upon information and belief, ANI was and is aware of the existence of the ’070
`
`patent and acted without a reasonable basis for believing that it would not be liable for infringement
`
`of the ’070 patent, thus rendering this case “exceptional” under 35 U.S.C. § 285.
`
`72.
`
`UTC will be substantially and irreparably damaged and harmed if ANI’s
`
`infringement of the ’070 patent is not enjoined by this Court. UTC does not have an adequate
`
`remedy at law.
`
`COUNT 2: INFRINGEMENT OF THE ’713 PATENT
`UNDER 35 U.S.C. §§ 271(a)-(c), (e) and (g)
`
`73.
`
`Plaintiffs repeat and reallege each of the foregoing paragraphs as if fully set forth
`
`herein.
`
`74.
`
`Upon information and belief, upon FDA approval, ANI will manufacture, market,
`
`sell, offer to sell, import, and distribute ANI’s ANDA Products, which will result in infringement
`
`of one or more claims of the ’713 patent.
`
`75.
`
`ANI’s submission of ANI’s ANDA and ANI’s intention to engage in the
`
`commercial manufacture, use, sale, offer for sale, or importation of ANI’s ANDA Product upon
`
`receiving FDA approval prior to the expiration of the ’713 patent creates an actual and justiciable
`
`controversy with respect to infringement of the ’713 patent.
`
`12
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`Case 1:21-cv-00489-UNA Document 1 Filed 04/01/21 Page 13 of 38 PageID #: 13
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`
`
`76.
`
`Upon information and belief, ANI’s submission of ANI’s ANDA and, upon FDA
`
`approval of ANI’s ANDA, ANI’s commercial manufacture, use, sale, offer for sale and/or
`
`importation into the United States of ANI’s ANDA Product has infringed and will directly infringe
`
`one or more claims of the ’713 patent, and will indirectly infringe by actively inducing
`
`infringement by others, under one or more of 35 U.S.C. § 271(a), 35 U.S.C. § 271(b), 35 U.S.C.
`
`§ 271(c), 35 U.S.C. § 271(e), and/or 35 U.S.C. § 271(g).
`
`77.
`
`ANI’s submission of ANI’s ANDA for the purpose of obtaining approval to engage
`
`in the commercial manufacture, use, sale, and/or offer for sale of ANI’s ANDA Product prior to
`
`expiration of the ’713 patent was an act of infringement of the ’713 patent under 35 U.S.C.
`
`§ 271(e)(2).
`
`78.
`
`Upon information and belief, ANI’s ANDA Product or an intermediate in its
`
`manufacture as described in and/or directed by ANI’s proposed labeling, ANDA, applicable DMF,
`
`and/or other corporate documents for ANI’s ANDA Product would infringe one or more claims of
`
`the ’713 patent.
`
`79.
`
`Upon information and belief, ANI will induce others to infringe one or more claims
`
`of the ’713 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, the manufacturer of ANI’s ANDA
`
`Product, or its API, or other subsequent purchasers, distributors, or users thereof, which product
`
`or its use constitutes direct infringement of one or more claims of the ’713 patent. Upon
`
`information and belief, ANI’s aiding and abetting includes ANI’s engagement of, contracting of,
`
`and/or encouragement of others to engage in the manufacture, use, sale, or importation of
`
`infringing products pursuant to ANI’s ANDA. ANI will do so with knowledge of the ’713 patent
`
`and intent to induce the infringement thereof.
`
`13
`
`
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`Case 1:21-cv-00489-UNA Document 1 Filed 04/01/21 Page 14 of 38 PageID #: 14
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`
`
`80.
`
`Upon information and belief, ANI will also contributorily infringe one or more
`
`claims of the ’713 patent under 35 U.S.C. § 271(c) in that ANI will make, use, sell, offer to sell,
`
`and/or import its ANDA Product and/or the API thereof, which ANI 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 ’713 patent.
`
`81.
`
`Upon information and belief, ANI will also infringe one or more claims of the ’713
`
`patent under 35 U.S.C. § 271(g) by importing, selling, offering to sell, or using ANI’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.
`
`82.
`
`Upon information and belief, ANI was and is aware of the existence of the ’713
`
`patent and acted without a reasonable basis for believing that it would not be liable for infringement
`
`of the ’713 patent, thus rendering this case “exceptional” under 35 U.S.C. § 285.
`
`83.
`
`UTC will be substantially and irreparably damaged and harmed if ANI’s
`
`infringement of the ’713 patent is not enjoined by this Court. UTC does not have an adequate
`
`remedy at law.
`
`COUNT 3: INFRINGEMENT OF THE ’839 PATENT
`UNDER 35 U.S.C. §§ 271(a)-(c), (e) and (g)
`
`84.
`
`Plaintiffs repeat and reallege each of the foregoing paragraphs as if fully set forth
`
`herein.
`
`85.
`
`Upon information and belief, upon FDA approval, ANI will manufacture, market,
`
`sell, offer to sell, import, and distribute ANI’s ANDA Products, which will result in infringement
`
`of one or more claims of the ’839 patent.
`
`86.
`
`ANI’s submission of ANI’s ANDA and ANI’s intention to engage in the
`
`commercial manufacture, use, sale, offer for sale, or importation of ANI’s ANDA Product upon
`
`14
`
`
`
`Case 1:21-cv-00489-UNA Document 1 Filed 04/01/21 Page 15 of 38 PageID #: 15
`
`
`
`receiving FDA approval prior to the expiration of the ’839 patent creates an actual and justiciable
`
`controversy with respect to infringement of the ’839 patent.
`
`87.
`
`Upon information and belief, ANI’s submission of ANI’s ANDA and, upon FDA
`
`approval of ANI’s ANDA, ANI’s commercial manufacture, use, sale, offer for sale and/or
`
`importation into the United States of ANI’s ANDA Product has infringed and will directly infringe
`
`one or more claims of the ’839 patent, and will indirectly infringe by actively inducing
`
`infringement by others, under one or more of 35 U.S.C. § 271(a), 35 U.S.C. § 271(b), 35 U.S.C.
`
`§ 271(c), 35 U.S.C. § 271(e), and/or 35 U.S.C. § 271(g).
`
`88.
`
`ANI’s submission of ANI’s ANDA for the purpose of obtaining approval to engage
`
`in the commercial manufacture, use, sale, and/or offer for sale of ANI’s ANDA Product prior to
`
`expiration of the ’839 patent was an act of infringement of the ’839 patent under 35 U.S.C.
`
`§ 271(e)(2).
`
`89.
`
`Upon information and belief, ANI’s ANDA Product or an intermediate in its
`
`manufacture as described in and/or directed by ANI’s proposed labeling, ANDA, applicable DMF,
`
`and/or other corporate documents for ANI’s ANDA Product would infringe one or more claims of
`
`the ’839 patent.
`
`90.
`
`Upon information and belief, ANI will induce others to infringe one or more claims
`
`of the ’839 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, the manufacturer of ANI’s ANDA
`
`Product, or its API, or other subsequent purchasers, distributors, or users thereof, which product
`
`or its use constitutes direct infringement of one or more claims of the ’839 patent. Upon
`
`information and belief, ANI’s aiding and abetting includes ANI’s engagement of, contracting of,
`
`and/or encouragement of others to engage in the manufacture, use, sale, or importation of
`
`15
`
`
`
`Case 1:21-cv-00489-UNA Document 1 Filed 04/01/21 Page 16 of 38 PageID #: 16
`
`
`
`infringing products pursuant to ANI’s ANDA. ANI will do so with knowledge of the ’839 patent
`
`and intent to induce the infringement thereof.
`
`91.
`
`Upon information and belief, ANI will also contributorily infringe one or more
`
`claims of the ’839 patent under 35 U.S.C. § 271(c) in that ANI will make, use, sell, offer to sell,
`
`and/or import its ANDA Product and/or the API thereof, which ANI 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 ’839 patent.
`
`92.
`
`Upon information and belief, ANI will also infringe one or more claims of the ’839
`
`patent under 35 U.S.C. § 271(g) by importing, selling, offering to sell, or using ANI’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.
`
`93.
`
`Upon information and belief, ANI was and is aware of the existence of the ’839
`
`patent and acted without a reasonable basis for believing that it would not be liable for infringement
`
`of the ’839 patent, thus rendering this case “exceptional” under 35 U.S.C. § 285.
`
`94.
`
`UTC will be substantially and irreparably damaged and harmed if ANI’s
`
`infringement of the ’839 patent is not enjoined by this Court. UTC does not have an adequate
`
`remedy at law.
`
`COUNT 4: INFRINGEMENT OF THE ’892 PATENT
`UNDER 35 U.S.C. §§ 271(a)-(c), (e) and (g)
`
`95.
`
`Plaintiffs repeat and reallege each of the foregoing paragraphs as if fully set forth
`
`herein.
`
`96.
`
`Upon information and belief, upon FDA approval, ANI will manufacture, market,
`
`sell, offer to sell, import, and distribute ANI’s ANDA Products, which will result in infringement
`
`of one or more claims of the ’892 patent.
`
`16
`
`
`
`Case 1:21-cv-00489-UNA Document 1 Filed 04/01/21 Page 17 of 38 PageID #: 17
`
`
`
`97.
`
`ANI’s submission of ANI’s ANDA and ANI’s intention to engage in the
`
`commercial manufacture, use, sale, offer for sale, or importation of ANI’s ANDA Product upon
`
`receiving FDA approval prior to the expiration of the ’892 patent creates an actual and justiciable
`
`controversy with respect to infringement of the ’892 patent.
`
`98.
`
`Upon information and belief, ANI’s submission of ANI’s ANDA and upon FDA
`
`approval of ANI’s ANDA, ANI’s commercial manufacture, use, sale, offer for sale and/or
`
`importation into the United States of ANI’s ANDA Product has infringed and will directly infringe
`
`one or more claims of the ’892 patent, and will indirectly infringe by actively inducing
`
`infringement by others, under one or more of 35 U.S.C. § 271(a), 35 U.S.C. § 271(b), 35 U.S.C.
`
`§ 271(c), 35 U.S.C. § 271(e), and/or 35 U.S.C. § 271(g).
`
`99.
`
`ANI’s submission of ANI’s ANDA for the purpose of obtaining approval to engage
`
`in the commercial manufacture, use, sale, and/or offer for sale of ANI’s ANDA Product prior to
`
`expiration of the ’892 patent was an act of infringement of the ’892 patent under 35 U.S.C.
`
`§ 271(e)(2).
`
`100. Upon information and belief, ANI’s ANDA Product or an intermediate in its
`
`manufacture as described in and/or directed by ANI’s proposed labeling, ANDA, applicable DMF,
`
`and/or other corporate documents for ANI’s ANDA Product would infringe one or more claims of
`
`the ’892 patent.
`
`101. Upon information and belief, ANI will induce others to infringe one or more claims
`
`of the ’892 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, the manufacturer of ANI’s ANDA
`
`Product, or its API, or other subsequent purchasers, distributors, or users thereof, which product
`
`or its use constitutes direct infringement of one or more claims of the ’892 patent. Upon
`
`17
`
`
`
`Case 1:21-cv-00489-UNA Document 1 Filed 04/01/21 Page 18 of 38 PageID #: 18
`
`
`
`information and belief, ANI’s aiding and abetting includes ANI’s engagement of, contracting of,
`
`and/or encouragement of others to engage in the manufacture, use, sale, or importation of
`
`infringing products pursuant to ANI’s ANDA. ANI will do so with knowledge of the ’892 patent
`
`and intent to induce the infringement thereof.
`
`102. Upon information and belief, ANI will also contributorily infringe one or more
`
`claims of the ’892 patent under 35 U.S.C. § 271(c) in that ANI will make, use, sell, offer to sell,
`
`and/or import its ANDA Product and/or the API thereof, which ANI 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 ’892 patent.
`
`103