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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
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`UNITED THERAPEUTICS
`CORPORATION,
`
`Plaintiff,
`
`v.
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`LIQUIDIA TECHNOLOGIES, INC.,
`
`Defendant.
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`)
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`)
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`)
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`C.A. No. 20-755 (RGA)
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`FIRST AMENDED COMPLAINT
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`Plaintiff United Therapeutics Corporation (“UTC”), by its undersigned attorneys, for its
`
`First Amended Complaint against Liquidia Technologies, Inc. (“Liquidia”), alleges 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. 9,593,066 (“the ’066 patent”) (attached as Exhibit A hereto), 9,604,901 (“the ’901 patent”)
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`(attached as Exhibit B hereto), and 10,716,793 (“the ’793 patent”) (attached as Exhibit C hereto)
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`(collectively, the “Patents-in-Suit”).
`
`2.
`
`This action arises out of Liquidia’s submission of New Drug Application No.
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`213005 under § 505(b)(2) of the Federal Food, Drug and Cosmetic Act (“Liquidia’s 505(b)(2)
`
`Application”) to the United States Food and Drug Administration (“FDA”) seeking approval,
`
`prior to the expiration of the ’066 patent, the ’901 patent, and the ’793 patent, to manufacture,
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`market, and sell a generic copy of UTC’s TYVASO® (treprostinil) Inhalation Solution,
`
`0.6 mg/ml that is approved by FDA for treatment of pulmonary arterial hypertension (“Liquidia’s
`
`Proposed Generic Product”).
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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. UTC
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`continues to research and develop treatments for cardiovascular and pulmonary diseases,
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`pediatric cancers, and other orphan diseases.
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`4.
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`Upon information and belief, Liquidia is a corporation organized and existing
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`under the laws of the State of Delaware, with a registered office at 51 Little Falls Drive,
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`Wilmington, Delaware 19808, and a principal place of business at 419 Davis Drive, Suite 100,
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`Morrisville, North Carolina 27560.
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`5.
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`Upon information and belief, to manufacture Liquidia’s Proposed Generic
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`Product, Liquidia purchases the treprostinil sodium active pharmaceutical ingredient (“API”)
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`from third-party manufacturer Yonsung Fine Chemicals Co., LTD (“Yonsung”), operating out of
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`South Korea. Upon information and belief, Liquidia will import treprostinil sodium API from
`
`Yonsung into the United States.
`
`6.
`
`Upon information and belief, Liquidia’s Proposed Generic Product delivers
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`treprostinil through a dry powder inhaler (“DPI”) that is manufactured by Plastiape SpA
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`(“Plastiape”). Upon information and belief, Plastiape has a principal place of business at Via
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`Primo Maggio, 8 Osnago, 23875 Italy. Upon information and belief, Plastiape is a wholly-
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`owned subsidiary of Berry Global Group, Inc. Upon information and belief, Berry Global
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`Group, Inc. has a principal place of business at 101 Oakley Street, Evansville, Indiana 47710.
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`JURISDICTION AND VENUE
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`7.
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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.
`
`8.
`
`9.
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`Venue is proper in this Court under 28 U.S.C. § 1400(b).
`
`Upon information and belief, this Court has personal jurisdiction over Liquidia
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`because it is a corporation organized and existing under the laws of the State of Delaware with a
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`registered agent in the State of Delaware. Further, upon information and belief, Liquidia has
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`publicly stated its intent to engage in commercializing Liquidia’s Proposed Generic Product
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`throughout the United States without any limitation. Upon information and belief, Liquidia will
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`manufacture, market, distribute, and/or sell Liquidia’s Proposed Generic Product throughout the
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`United States, including in Delaware, and will derive substantial revenue therefrom. Upon
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`information and belief, upon approval of Liquidia’s 505(b)(2) Application, Liquidia will place
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`Liquidia’s Proposed Generic Product into the stream of commerce with the reasonable
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`expectation or knowledge and the intent that such products will ultimately be purchased and used
`
`by consumers in Delaware.
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`BACKGROUND
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`10.
`
`UTC holds New Drug Application No. 022387, which has been approved for
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`TYVASO® (treprostinil) Inhalation Solution, 0.6 mg/ml, which UTC markets and sells under the
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`registered trademark TYVASO®.
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`11.
`
`TYVASO® is a pharmaceutical product initially approved by FDA in the United
`
`States in July 2009 and is indicated for the treatment of pulmonary arterial hypertension.
`
`Pulmonary arterial hypertension is a rare disease affecting the pulmonary vasculature and results
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`3
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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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`12.
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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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`13.
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`The ’066 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
`
`March 14, 2017, and is scheduled to expire on December 15, 2028. The named inventors are
`
`Hitesh Batra, Sudersan M. Tuladhar, Raju Penmasta, and David A. Walsh.
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`14.
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`UTC is the lawful owner of the ’066 patent by assignment of all right, title and
`
`interest in and to the ’066 patent, including the right to bring infringement suits thereon.
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`15.
`
`The ’901 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, and is scheduled to expire on December 15, 2028. The named inventors are
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`Hitesh Batra, Sudersan M. Tuladhar, Raju Penmasta, and David A. Walsh.
`
`16.
`
`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 bring infringement suits thereon.
`
`17.
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`The ’793 patent, entitled “Treprostinil Administration by Inhalation,” was duly
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`and legally issued by the United States Patent and Trademark Office on July 21, 2020, and is
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`scheduled to expire on May 14, 2027. The named inventors are Horst Olschewski, Robert
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`Roscigno, Lewis J. Rubin, Thomas Schmehl, Werner Seeger, Carl Sterritt, and Robert
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`Voswinckel.
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`18.
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`UTC is the lawful owner of the ’793 patent by assignment of all right, title and
`
`interest in and to the ’793 patent, including the right to bring infringement suits thereon.
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`19.
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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 ’066 patent, the ’901 patent, and the ’793 patent, which have 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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`20.
`
`Liquidia notified UTC by letter dated April 24, 2020, which was delivered to UTC
`
`on or about April 27, 2020 (“Liquidia’s Notice Letter”), that it had submitted NDA No. 213005 to
`
`the FDA seeking approval to engage in the commercial manufacture, use and/or sale of Liquidia’s
`
`Proposed Generic Product prior to the expiration of the’066 patent and the ’901 patent.
`
`21.
`
`Liquidia’s Notice Letter
`
`included a statement pursuant
`
`to 21 U.S.C.
`
`§ 355(b)(3)(D)(ii) and 21 C.F.R. § 314.52(c)(6) purporting to recite Liquidia’s “factual and legal
`
`basis” for its opinion that the ’066 patent and the ’901 patent are invalid, unenforceable, and/or
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`are not, and will not, be infringed by the commercial manufacture, use or sale of Liquidia’s
`
`Proposed Generic Product. That statement did not include anything beyond conclusory
`
`statements as to why the claims of the ’066 patent and the ’901 patent were allegedly invalid. The
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`statement also did not include anything beyond conclusory statements regarding alleged non-
`
`infringement.
`
`22.
`
`Upon information and belief, Liquidia submitted Liquidia’s 505(b)(2) Application
`
`to FDA seeking approval to commercially manufacture, market, use, and sell generic copies of
`
`UTC’s TYVASO® (treprostinil) Inhalation Solution, 0.6 mg/mL prior to the expiration of the ’066
`
`patent and the ’901 patent.
`
`23.
`
`UTC commenced this action before the expiration of forty-five days from the date
`
`it received Liquidia’s Notice Letter.
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`24.
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`Upon information and belief, Liquidia’s Proposed Generic Product contains the
`
`same active compound, treprostinil, as UTC’s approved TYVASO® product.
`
`25.
`
`Upon information and belief, Liquidia’s 505(b)(2) Application seeks approval
`
`from the FDA to market Liquidia’s Proposed Generic Product for the same indication as UTC’s
`
`approved TYVASO® product.
`
`26.
`
`Upon information and belief, Liquidia’s 505(b)(2) Application refers to and relies
`
`upon UTC’s NDA No. 022387 for TYVASO® (treprostinil) Inhalation Solution, 0.6 mg/ml.
`
`27.
`
`Upon information and belief, Liquidia intends to commercially manufacture, sell,
`
`offer for sale, and/or import Liquidia’s Proposed Generic Product upon, or in anticipation of,
`
`FDA approval.
`
`28.
`
`According to Liquidia’s Notice Letter, Liquidia’s 505(b)(2) Application contained
`
`a “Paragraph IV” certification pursuant to 21 U.S.C. § 355(b)(2)(A)(iv) stating that in Liquidia’s
`
`opinion the ’066 and the ’901 patents are invalid, unenforceable, and/or would not be infringed
`
`by the commercial manufacture, use or sale of Liquidia’s Proposed Generic Product.
`
`29.
`
`Upon information and belief, as of the date of Liquidia’s Notice Letter, Liquidia
`
`was aware of the statutory provisions and regulations set forth in 21 U.S.C. § 355(b)(3)(D)(ii)
`
`and 21 C.F.R. § 314.52(c)(6).
`
`30.
`
`In Liquidia’s Notice Letter, Liquidia offered confidential access to certain
`
`information regarding Liquidia’s 505(b)(2) Application on the terms and conditions set forth in
`
`that letter (“Liquidia’s Offer of Confidential Access”). Liquidia requested that UTC accept
`
`Liquidia’s Offer of Confidential Access before receiving access to information regarding
`
`Liquidia’s 505(b)(2) Application. Liquidia’s Offer of Confidential Access contained sweeping,
`
`unreasonable restrictions that differ materially from restrictions found under protective orders.
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`For example, Liquidia’s Offer of Confidential Access required that UTC’s outside counsel “do
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`not engage, either formally or informally, in any patent prosecution for UTC and/or are involved
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`in the subject matter related to treprostinil, and/or provide any FDA counseling, litigation or
`
`other work before or involving FDA.”
`
`31.
`
`Under 21 U.S.C. § 355(c)(3)(D)(i)(III), an “offer of confidential access shall
`
`contain such restrictions . . . on the use and disposition of any information accessed, as would
`
`apply had a protective order been entered for the purpose of protecting trade secrets and other
`
`confidential business information.”
`
`32.
`
`UTC attempted to negotiate with Liquidia to obtain relevant information from
`
`Liquidia’s 505(b)(2) Application under restrictions “as would apply had a protective order been
`
`issued.” Those negotiations were unsuccessful. For example, Liquidia continued to insist that
`
`attorneys representing UTC and in-house counsel and the staff of such counsel agree not to be
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`engaged in the drafting of submissions related to compositions, treatment methods, or
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`formulations containing treprostinil to the FDA or to provide any FDA counseling related to such
`
`matters, though such restrictions have not been present in any prior protective order relating to
`
`any other UTC treprostinil-containing product, such as REMODULIN® (treprostinil) Injection.
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`See United 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. Nov. 25, 2014); United Therapeutics Corp. v. Sandoz, Inc., 3:14-
`
`cv-05499-PGS-LHG, Stipulated Protective Order and Cross Use Agreement (D.N.J. Jan. 15,
`
`2015.). UTC objected to this provision of Liquidia’s Offer of Confidential Access as
`
`unreasonable and in violation of 21 U.S.C. § 355(j)(5)(C)(i)(III).
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`33.
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`UTC is not aware of any other means of obtaining information regarding
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`Liquidia’s Proposed Generic Product within the 45-day statutory period. Without such
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`information, UTC will use the judicial process and the aid of discovery to obtain, under
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`appropriate judicial safeguards, such information as is required to confirm its allegations of
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`infringement and to present to the Court evidence that Liquidia’s Proposed Generic Product falls
`
`within the scope of one or more claims of the ’066 and ’901 patents.
`
`34.
`
`Upon information and belief, Liquidia’s Proposed Generic Product is intended to
`
`deliver treprostinil through a DPI utilizing capsules in amounts from 26.5-106 mcgs of
`
`treprostinil, and doses from 26.5-212 mcgs of treprostinil. Upon information and belief, the
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`contents of each capsule of Liquidia’s Proposed Generic Product “can be inhaled in 1-2 breaths.”
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`COUNT 1: INFRINGEMENT OF THE ’066 PATENT
`UNDER 35 U.S.C. § 271(e)
`
`35.
`
`UTC repeats and realleges each of the foregoing paragraphs as if fully set forth
`
`herein.
`
`36.
`
`Upon information and belief, Liquidia’s Proposed Generic Product or an
`
`intermediate in its manufacture is covered by one or more claims of the ’066 patent.
`
`37.
`
`Liquidia had knowledge of the ’066 patent when it submitted Liquidia’s 505(b)(2)
`
`Application.
`
`38.
`
`Liquidia’s submission of Liquidia’s 505(b)(2) Application for the purpose of
`
`obtaining approval to engage in the commercial manufacture, use and/or sale of Liquidia’s
`
`Proposed Generic Product was an act of infringement of the ’066 patent under 35 U.S.C.
`
`§ 271(e)(2).
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`8
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`39.
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`Upon information and belief, the commercial manufacture, use, offer for sale, sale
`
`and/or importation of Liquidia’s Proposed Generic Product would infringe one or more claims of
`
`the ’066 patent.
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`40.
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`Upon information and belief, Liquidia was and is aware of the existence of the
`
`’066 patent and acted without a reasonable basis for believing that it would not be liable for
`
`infringement of the ’066 patent, thus rendering this case “exceptional” under 35 U.S.C. § 285.
`
`41.
`
`UTC will be substantially and irreparably damaged and harmed if Liquidia’s
`
`infringement of the ’066 patent is not enjoined by this Court. UTC does not have an adequate
`
`remedy at law.
`
`COUNT 2: INFRINGEMENT OF THE ’066 PATENT
`UNDER 35 U.S.C. §§ 271(a)-(c) and (g)
`
`42.
`
`UTC repeats and realleges each of the foregoing paragraphs as if fully set forth
`
`herein.
`
`43.
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`Upon information and belief, upon FDA approval of Liquidia’s 505(b)(2)
`
`Application, Liquidia will engage in the commercial manufacture, use, offer for sale, sale, and/or
`
`importation of Liquidia’s Proposed Generic Product which will result in infringement of one or
`
`more claims of the ’066 patent.
`
`44.
`
`Liquidia’s 505(b)(2) Application and Liquidia’s intention to engage in the
`
`commercial manufacture, use, offer for sale, sale, and/or importation of Liquidia’s Proposed
`
`Generic Product upon receiving FDA approval prior to the expiration of the ’066 patent creates
`
`an actual and justiciable controversy with respect to infringement of the ’066 patent.
`
`45.
`
`Upon information and belief, upon FDA’s approval of Liquidia’s 505(b)(2)
`
`Application, Liquidia’s commercial manufacture, use, sale, offer for sale, and/or importation into
`
`the United States of Liquidia’s Proposed Generic Product will directly infringe one or more
`
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`claims of the ’066 patent, and will indirectly infringe by actively inducing infringement by
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`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).
`
`46.
`
`Upon information and belief, Liquidia’s Proposed Generic Product or an
`
`intermediate in its manufacture as described in and/or directed by Liquidia’s proposed labeling,
`
`Liquidia’s 505(b)(2) Application, applicable drug master file (“DMF”), and/or other corporate
`
`documents for Liquidia’s Proposed Generic Product would infringe one or more claims of the
`
`’066 patent.
`
`47.
`
`Upon information and belief, Liquidia will induce others to infringe one or more
`
`claims of the ’066 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 Liquidia’s Proposed Generic Product, or its API, or other subsequent purchasers, distributors,
`
`or users thereof, which product or its manufacture constitutes direct infringement of one or more
`
`claims of the ’066 patent. Upon information and belief, Liquidia’s aiding and abetting includes
`
`Liquidia’s engagement of, contracting of, and/or encouragement of others to engage in the
`
`manufacture, use, sale, or importation of infringing products pursuant to Liquidia’s 505(b)(2)
`
`Application.
`
`48.
`
`Upon information and belief, Liquidia will also contributorily infringe one or
`
`more claims of the ’066 patent under 35 U.S.C. § 271(c) in that Liquidia will make, use, sell,
`
`offer to sell, and/or import Liquidia’s Proposed Generic Product and/or the API thereof, which
`
`Liquidia 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
`
`’066 patent.
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`49.
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`Upon information and belief, Liquidia will also infringe one or more claims of the
`
`’066 patent under 35 U.S.C. § 271(g) by importing, selling, offering to sell or using Liquidia’s
`
`Proposed Generic 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.
`
`50.
`
`Upon information and belief, Liquidia was and is aware of the existence of the
`
`’066 patent and acted without a reasonable basis for believing that it would not be liable for
`
`infringement of the ’066 patent, thus rendering this case “exceptional” under 35 U.S.C. § 285.
`
`51.
`
`UTC will be substantially and irreparably damaged and harmed if Liquidia’s
`
`infringement of the ’066 patent is not enjoined by this Court. UTC does not have an adequate
`
`remedy at law.
`
`COUNT 3: INFRINGEMENT OF THE ’901 PATENT
`UNDER 35 U.S.C. § 271(e)
`
`52.
`
`UTC repeats and realleges each of the foregoing paragraphs as if fully set forth
`
`herein.
`
`53.
`
`Upon information and belief, Liquidia’s Proposed Generic Product or an
`
`intermediate in its manufacture is covered by one or more claims of the ’901 patent.
`
`54.
`
`Liquidia had knowledge of the ’901 patent when it submitted Liquidia’s 505(b)(2)
`
`Application.
`
`55.
`
`Liquidia’s submission of Liquidia’s 505(b)(2) Application for the purpose of
`
`obtaining approval to engage in the commercial manufacture, use, sale, and/or offer for sale of
`
`Liquidia’s Proposed Generic Product was an act of infringement of the ’901 patent under
`
`35 U.S.C. § 271(e)(2).
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`56.
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`Upon information and belief, the commercial manufacture, use, offer for sale, sale
`
`and/or importation of Liquidia’s Proposed Generic Product would infringe one or more claims of
`
`the ’901 patent.
`
`57.
`
`Upon information and belief, Liquidia was and is aware of the existence of the
`
`’901 patent and acted without a reasonable basis for believing that it would not be liable for
`
`infringement of the ’901 patent, thus rendering this case “exceptional” under 35 U.S.C. § 285.
`
`58.
`
`UTC will be substantially and irreparably damaged and harmed if Liquidia’s
`
`infringement of the ’901 patent is not enjoined by this Court. UTC does not have an adequate
`
`remedy at law.
`
`COUNT 4: INFRINGEMENT OF THE ’901 PATENT
`UNDER 35 U.S.C. §§ 271(a)-(c) and (g)
`
`59.
`
`UTC repeats and realleges each of the foregoing paragraphs as if fully set forth
`
`herein.
`
`60.
`
`Upon information and belief, upon FDA approval, Liquidia will manufacture,
`
`market, sell, offer to sell, import, and distribute Liquidia’s Proposed Generic Product which will
`
`result in infringement of one or more claims of the ’901 patent.
`
`61.
`
`Liquidia’s 505(b)(2) Application and Liquidia’s intention to engage in the
`
`commercial manufacture, use, offer for sale, sale, and/or importation of Liquidia’s Proposed
`
`Generic Product upon receiving FDA approval of Liquidia’s 505(b)(2) Application prior to the
`
`expiration of the ’901 patent creates an actual and justiciable controversy with respect to
`
`infringement of the ’901 patent.
`
`62.
`
`Upon information and belief, upon FDA’s approval of Liquidia’s 505(b)(2)
`
`Application, Liquidia’s commercial manufacture, use, sale, offer for sale, and/or importation into
`
`the United States of Liquidia’s Proposed Generic Product will directly infringe one or more
`
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`claims of the ’901 patent, and will indirectly infringe by actively inducing infringement by
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`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).
`
`63.
`
`Upon information and belief, Liquidia’s Proposed Generic Product or an
`
`intermediate in its manufacture as described in and/or directed by Liquidia’s proposed labeling,
`
`Liquidia’s 505(b)(2) Application, applicable DMF, and/or other corporate documents for
`
`Liquidia’s Proposed Generic Product would infringe one or more claims of the ’901 patent.
`
`64.
`
`Upon information and belief, Liquidia will induce others to infringe one or more
`
`claims of the ’901 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 Liquidia’s Proposed Generic Product, or its API, or other subsequent purchasers, distributors,
`
`or users thereof, which product or its manufacture constitutes direct infringement of one or more
`
`claims of the ’901 patent. Upon information and belief, Liquidia’s aiding and abetting includes
`
`Liquidia’s engagement of, contracting of, and/or encouragement of others to engage in the
`
`manufacture, use, sale, or importation of infringing products pursuant to Liquidia’s 505(b)(2)
`
`Application.
`
`65.
`
`Upon information and belief, Liquidia will also contributorily infringe one or
`
`more claims of the ’901 patent under 35 U.S.C. § 271(c) in that Liquidia will make, use, sell,
`
`offer to sell, and/or import Liquidia’s Proposed Generic Product and/or the API thereof, which
`
`Liquidia 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
`
`’901 patent.
`
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`66.
`
`Upon information and belief, Liquidia will also infringe one or more claims of the
`
`’901 patent under 35 U.S.C. § 271(g) by importing, selling, offering to sell or using Liquidia’s
`
`Proposed Generic 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.
`
`67.
`
`Upon information and belief, Liquidia was and is aware of the existence of the
`
`’901 patent and acted without a reasonable basis for believing that it would not be liable for
`
`infringement of the ’901 patent, thus rendering this case “exceptional” under 35 U.S.C. § 285.
`
`68.
`
`UTC will be substantially and irreparably damaged and harmed if Liquidia’s
`
`infringement of the ’901 patent is not enjoined by this Court. UTC does not have an adequate
`
`remedy at law.
`
`COUNT 5: INFRINGEMENT OF THE ’793 PATENT
`UNDER 35 U.S.C. § 271(e)
`
`69.
`
`UTC repeats and realleges each of the foregoing paragraphs as if fully set forth
`
`herein.
`
`70.
`
`Upon information and belief, Liquidia’s Proposed Generic Product is covered by
`
`one or more claims of the ’793 patent.
`
`71.
`
`Liquidia’s maintenance of Liquidia’s 505(b)(2) Application for the purpose of
`
`obtaining approval to engage in the commercial manufacture, use, sale, and/or offer for sale of
`
`Liquidia’s Proposed Generic Product is an act of infringement of the ’793 patent under 35 U.S.C.
`
`§ 271(e)(2).
`
`72.
`
`Upon information and belief, the commercial manufacture, use, offer for sale, sale
`
`and/or importation of Liquidia’s Proposed Generic Product would infringe one or more claims of
`
`the ’793 patent.
`
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`73.
`
`Upon information and belief, Liquidia was and is aware of the existence of the
`
`’793 patent and acted without a reasonable basis for believing that it would not be liable for
`
`infringement of the ’793 patent, thus rendering this case “exceptional” under 35 U.S.C. § 285.
`
`74.
`
`UTC will be substantially and irreparably damaged and harmed if Liquidia’s
`
`infringement of the ’793 patent is not enjoined by this Court. UTC does not have an adequate
`
`remedy at law.
`
`COUNT 6: INFRINGEMENT OF THE ’793 PATENT
`UNDER 35 U.S.C. §§ 271(a)-(c)
`
`75.
`
`UTC repeats and realleges each of the foregoing paragraphs as if fully set forth
`
`herein.
`
`76.
`
`Upon information and belief, upon FDA approval, Liquidia will manufacture,
`
`market, sell, offer to sell, import, and distribute Liquidia’s Proposed Generic Product which will
`
`result in infringement of one or more claims of the ’793 patent.
`
`77.
`
`Liquidia’s 505(b)(2) Application and Liquidia’s intention to engage in the
`
`commercial manufacture, use, offer for sale, sale, and/or importation of Liquidia’s Proposed
`
`Generic Product upon receiving FDA approval of Liquidia’s 505(b)(2) Application prior to the
`
`expiration of the ’793 patent creates an actual and justiciable controversy with respect to
`
`infringement of the ’793 patent.
`
`78.
`
`Upon information and belief, upon FDA’s approval of Liquidia’s 505(b)(2)
`
`Application, Liquidia’s commercial manufacture, use, sale, offer for sale, and/or importation into
`
`the United States of Liquidia’s Proposed Generic Product will directly infringe one or more
`
`claims of the ’793 patent, and will indirectly infringe by actively inducing infringement by
`
`others, under 35 U.S.C. § 271(a), 35 U.S.C. § 271(b), and/or 35 U.S.C. § 271(c).
`
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`79.
`
`Upon information and belief, Liquidia’s Proposed Generic Product or an
`
`intermediate in its manufacture as described in and/or directed by Liquidia’s proposed labeling,
`
`Liquidia’s 505(b)(2) Application, applicable DMF, and/or other corporate documents for
`
`Liquidia’s Proposed Generic Product would infringe one or more claims of the ’793 patent.
`
`80.
`
`Upon information and belief, Liquidia will induce others to infringe one or more
`
`claims of the ’793 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 Liquidia’s Proposed Generic Product, or its API, or other subsequent purchasers, distributors,
`
`or users thereof, which product or its manufacture constitutes direct infringement of one or more
`
`claims of the ’793 patent. Upon information and belief, Liquidia’s aiding and abetting includes
`
`Liquidia’s engagement of, contracting of, and/or encouragement of others to engage in the
`
`manufacture, use, sale, or importation of infringing products pursuant to Liquidia’s 505(b)(2)
`
`Application.
`
`81.
`
`Upon information and belief, Liquidia will also contributorily infringe one or
`
`more claims of the ’793 patent under 35 U.S.C. § 271(c) in that Liquidia will make, use, sell,
`
`offer to sell, and/or import Liquidia’s Proposed Generic Product and/or the API thereof, which
`
`Liquidia 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
`
`’793 patent.
`
`82.
`
`Upon information and belief, Liquidia was and is aware of the existence of the
`
`’793 patent and acted without a reasonable basis for believing that it would not be liable for
`
`infringement of the ’793 patent, thus rendering this case “exceptional” under 35 U.S.C. § 285.
`
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`83.
`
`UTC will be substantially and irreparably damaged and harmed if Liquidia’s
`
`infringement of the ’793 patent is not enjoined by this Court. UTC does not have an adequate
`
`remedy at law.
`
`PRAYER FOR RELIEF
`
`WHEREFORE, UTC requests the following relief:
`
`1.
`
`A judgment that:
`
`A. Liquidia has infringed the ’066 patent, the ’901 patent, and the ’793 patent;
`
`and
`
`B.
`
`declaring that making, using, selling, offering for sale, or importing into the
`
`United States of Liquidia’s Proposed Generic Product, or any product or
`
`compound that infringes one or more of the ’066 patent, the ’901 patent,
`
`and the ’793 patent, prior to the expiration dates of the respective patents,
`
`will infringe, actively induce infringement of, and contribute to the
`
`infringement by others of the ’066 patent, the ’901 patent, and the
`
`’793 patent;
`
`2.
`
`A judgment ordering that the effective date of any FDA approval of Liquidia’s
`
`NDA No. 213005 permitting Liquidia to commercially manufacture, make, use, offer to sell, sell,
`
`market, or import into the United States Liquidia’s Proposed Generic Product be not earlier than
`
`the latest of the expiration dates of the ’066 patent, the ’901 patent, and the ’793 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 Liquidia, its officer, agents, servants, employees, parents, subsidiaries, affiliate
`
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`corporations, other business entities and all other persons acting in concert, participation, or
`
`privity with t