Case 1:20-cv-00755-RGA-JLH Document 11 Filed 07/16/20 Page 1 of 21 PageID #: 63
`
`IN THE UNITED STATES DISTRICT COURT
`
`FOR THE DISTRICT OF DELAWARE
`
`UNITED THERAPEUTICS
`CORPORATION,
`
`Plaintiff,
`
`v.
`
`
`
`LIQUIDIA TECHNOLOGIES, INC.,
`
`Defendant.
`
`)
`)
`)
`)
`)
`) C.A. No. 20-755-RGA
`)
`)
`)
`)
`
`DEFENDANT’S ANSWER TO COMPLAINT AND COUNTERCLAIMS
`
`Defendant Liquidia Technologies, Inc. (“Liquidia” or “Defendant”) hereby files its answer,
`
`defenses, and counterclaims (“Answer”) to the Complaint filed by Plaintiff United Therapeutics
`
`Corporation (“UTC” or “Plaintiff”). Each of the paragraphs below corresponds to the same
`
`numbered paragraphs in the Complaint. In responding to the Complaint, Liquidia has kept
`
`Plaintiff’s headings for ease of reference, but in so doing, Liquidia is not admitting to the accuracy
`
`of any statements made or agreeing with any characterizations made in such headings. Liquidia
`
`denies all allegations in the Complaint, whether express or implied, that are not specifically
`
`admitted below. Liquidia further denies that Plaintiff is entitled to the relief requested in the
`
`Complaint, or to any other relief.
`
`NATURE OF THE ACTION
`
`1.
`
`Liquidia admits that the Complaint purports to assert a patent infringement action.
`
`Liquidia admits that U.S. Patent No. 9,593,066 (the “’066 patent”) and U.S. Patent No. 9,604,901
`
`(the “’901 patent”) (collectively the “patents-in-suit”) each bear the title “Process to Prepare
`
`Treprostinil, the Active Ingredient in Remodulin®”. Liquidia admits that Exhibits A and B
`
`attached to the Complaint appear to be copies of the ’066 and ’901 patents. Liquidia is without
`
`IPR2021-00406
`United Therapeutics EX2011
`Page 1 of 21
`
`

`

`Case 1:20-cv-00755-RGA-JLH Document 11 Filed 07/16/20 Page 2 of 21 PageID #: 64
`
`
`knowledge or information sufficient to form a belief as to the truth of the remaining allegations in
`
`paragraph 1, and therefore denies them.
`
`2.
`
`Liquidia admits that it submitted New Drug Application No. 213005 under
`
`§ 505(b)(2) of the Federal Food, Drug and Cosmetic Act (“Liquidia’s NDA”) to the United States
`
`Food and Drug Administration (“FDA”) seeking approval to engage in the commercial
`
`manufacture, use and/or sale of LIQ861 (treprostinil) inhalation powder (the “Liquidia Product”
`
`or “LIQ861 Product”). Liquidia denies the remaining allegations in paragraph 2.
`
`THE PARTIES
`
`3.
`
`Liquidia is without knowledge or information sufficient to form a belief as to the
`
`truth of the allegations in paragraph 3, and therefore denies them.
`
`4.
`
`5.
`
`Liquidia admits the allegations in paragraph 4.
`
`Liquidia admits that it purchases treprostinil from Yonsung Fine Chemicals Co.,
`
`LTD. Liquidia denies the remaining allegations in paragraph 5.
`
`6.
`
`Liquidia admits that the Liquidia Product delivers treprostinil through a dry powder
`
`inhaler (“DPI”) that is manufactured by Plastiape SpA (“Plastiape”). Liquidia denies the
`
`remaining allegations in paragraph 6.
`
`JURISDICTION AND VENUE
`
`7.
`
`Liquidia admits that this Court has subject matter jurisdiction over this case
`
`pursuant to 28 U.S.C. §§ 1331 and 1338(a), provided that standing and other requirements are met.
`
`Liquidia denies that the Plaintiff’s claims in its complaint have any merit or that Plaintiff is entitled
`
`to any relief. Liquidia denies the remaining allegations in paragraph 7.
`
`8.
`
`9.
`
`Liquidia admits that venue is proper for purposes of this case.
`
`Liquidia admits that this Court has personal jurisdiction over Liquidia for purposes
`
`of this case. Liquidia denies the remaining allegations in paragraph 9.
`
`- 2 -
`
`IPR2021-00406
`United Therapeutics EX2011
`Page 2 of 21
`
`

`

`Case 1:20-cv-00755-RGA-JLH Document 11 Filed 07/16/20 Page 3 of 21 PageID #: 65
`
`
`BACKGROUND
`
`10.
`
`Liquidia admits that UTC is identified as the holder of New Drug Application No.
`
`022387, which has been approved for TYVASO® (treprostinil) Inhalation Solution, 0.6 mg/ml.
`
`Liquidia is without knowledge or information sufficient to form a belief as to the truth of the
`
`remaining allegations in paragraph 10, and therefore denies them.
`
`11.
`
`Liquidia admits that TYVASO® was approved by the FDA in the United States on
`
`July 20, 2009, and, according to the TYVASO® prescribing information, is indicated “for the
`
`treatment of pulmonary arterial hypertension (WHO Group I) in patients with NYHA Class III
`
`symptoms, to increase walk distance.” Liquidia denies the remaining allegations in paragraph 11.
`
`12.
`
`Liquidia admits that TYVASO®, according to its prescribing information, is a
`
`sterile solution for oral inhalation: 2.9 mL ampule containing 1.74 mg treprostinil (0.6 mg per mL).
`
`13.
`
`Liquidia admits that the ’066 patent is entitled “Process to prepare treprostinil, the
`
`active ingredient in Remodulin®,” was issued by the United States Patent and Trademark Office
`
`on March 14, 2017, and names as inventors Hitesh Batra, Sudersan M. Tuladhar, Raju Penmasta,
`
`and David A. Walsh. Liquidia denies the remaining allegations in paragraph 13.
`
`14.
`
`Liquidia is without knowledge or information sufficient to form a belief as to the
`
`truth of the allegations in paragraph 14, and therefore denies them.
`
`15.
`
`Liquidia admits that the ’901patent is entitled “Process to prepare treprostinil, the
`
`active ingredient in Remodulin®,” was issued by the United States Patent and Trademark Office
`
`on March 28, 2017, and names as inventors Hitesh Batra, Sudersan M. Tuladhar, Raju Penmasta,
`
`and David A. Walsh. Liquidia denies the remaining allegations in paragraph 15.
`
`16.
`
`Liquidia is without knowledge or information sufficient to form a belief as to the
`
`truth of the allegations in paragraph 16, and therefore denies them.
`
`17.
`
`Liquidia admits that the ’066 and ’901 patents are listed in the Orange Book (FDA’s
`
`- 3 -
`
`IPR2021-00406
`United Therapeutics EX2011
`Page 3 of 21
`
`

`

`Case 1:20-cv-00755-RGA-JLH Document 11 Filed 07/16/20 Page 4 of 21 PageID #: 66
`
`
`Approved Drug Products with Therapeutic Equivalence Evaluations publication) in connection
`
`with TYVASO®. Liquidia denies the remaining allegations in paragraph 17.
`
`[ALLEGED] ACTS GIVING RISE TO THIS ACTION
`
`18.
`
`Liquidia admits that it notified UTC by letter dated April 24, 2020 (“Liquidia’s
`
`Notice Letter”) that it had submitted Liquidia’s NDA to the FDA seeking approval to engage in
`
`the commercial manufacture, use and/or sale of the Liquidia Product. Liquidia is without
`
`knowledge or information sufficient to form a belief as to the truth of the remaining allegations in
`
`paragraph 18, and therefore denies them.
`
`19.
`
`Liquidia admits that its Notice Letter included a detailed statement of the present
`
`factual and legal basis that the claims of the ’066 and/or ’901 patents are invalid, unenforceable
`
`and/or are not, and will not, be infringed by the Liquidia Product. Liquidia denies the remaining
`
`allegations in paragraph 19.
`
`20.
`
`Liquidia admits that it submitted its NDA to the FDA seeking approval to engage
`
`in the commercial manufacture, use and/or sale of the Liquidia Product. Liquidia denies the
`
`remaining allegations of paragraph 20.
`
`21.
`
`22.
`
`Liquidia admits that UTC filed its Complaint on June 4, 2020.
`
`Liquidia admits that the Liquidia Product contains treprostinil. Liquidia denies the
`
`remaining allegations in paragraph 22.
`
`23.
`
`Liquidia admits that its NDA seeks approval from the FDA to market Liquidia’s
`
`Product for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) to improve
`
`exercise ability in patients with NYHA Functional Class II-III symptoms. Liquidia denies the
`
`remaining allegations in paragraph 23.
`
`24.
`
`Liquidia admits that it filed its NDA, which is in compliance with all relevant
`
`statutory sections. Liquidia denies the remaining allegations in paragraph 24.
`
`- 4 -
`
`IPR2021-00406
`United Therapeutics EX2011
`Page 4 of 21
`
`

`

`Case 1:20-cv-00755-RGA-JLH Document 11 Filed 07/16/20 Page 5 of 21 PageID #: 67
`
`
`25.
`
`Liquidia admits that it submitted its NDA to the FDA seeking approval to engage
`
`in the commercial manufacture, use and/or sale of the Liquidia Product. Liquidia denies the
`
`remaining allegations in paragraph 25.
`
`26.
`
`Liquidia admits that its NDA contains Paragraph IV Certifications that the ’066
`
`patent and ’901 patent are not infringed by Liquidia’s Proposed Product and/or are invalid and/or
`
`unenforceable.
`
`27.
`
`Liquidia admits that its Notice Letter refers to 21 U.S.C. § 355(b)(3)(D)(ii) and
`
`21 C.F.R. § 314.52(c)(6).
`
`28.
`
`Liquidia admits that its Notice Letter contained an Offer of Confidential Access
`
`Pursuant to 21 U.S.C. § 355(c)(3)(D)(i)(III) (“OCA”). Liquidia further admits that Liquidia
`
`negotiated the terms of confidential access in good faith in order to permit UTC access to
`
`information contained within Liquidia’s NDA. Liquidia denies the remaining allegations in
`
`paragraph 28.
`
`29.
`
`Liquidia admits that 21 U.S.C. § 355(c)(3)(D)(i)(III) states an “offer of confidential
`
`access shall contain such restrictions as to persons entitled to access, and 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.”
`
`30.
`
`Liquidia admits that it attempted to negotiate the terms of its OCA with UTC.
`
`Liquidia’s OCA contained provisions that would apply to protective orders. For example,
`
`Liquidia’s OCA contained reasonable access restrictions on attorneys representing UTC and in-
`
`house counsel and the staff of such counsel that were present in the protective order entered into
`
`by UTC in United Therapeutics Corp. v. Watson Labs., Inc., No. 3:15-cv-05723-PGS-LHG, Dkt.
`
`No. 36 at 6-7 (D.N.J. Jan. 13, 2016), which is a prior litigation concerning TYVASO®. Liquidia
`
`- 5 -
`
`IPR2021-00406
`United Therapeutics EX2011
`Page 5 of 21
`
`

`

`Case 1:20-cv-00755-RGA-JLH Document 11 Filed 07/16/20 Page 6 of 21 PageID #: 68
`
`
`admits that UTC unilaterally rejected Liquidia’s OCA. Liquidia denies the remaining allegations
`
`in paragraph 30.
`
`31.
`
`Liquidia is without knowledge or information sufficient to form a belief as to the
`
`truth of the allegations in paragraph 31, and therefore denies them.
`
`COUNT 1: [ALLEGED] INFRINGEMENT OF THE ’066 PATENT
`UNDER 35 U.S.C. § 271(e)
`
`32.
`
`Liquidia incorporates by reference its responses to Paragraphs 1 through 31 of the
`
`Complaint.
`
`33.
`
`34.
`
`Liquidia denies the allegations of paragraph 33.
`
`Liquidia admits that Liquidia’s NDA included a Paragraph IV certification with
`
`respect to the ’066 patent.
`
`35.
`
`36.
`
`37.
`
`38.
`
`Liquidia denies the allegations of paragraph 35.
`
`Liquidia denies the allegations of paragraph 36.
`
`Liquidia denies the allegations of paragraph 37.
`
`Liquidia denies the allegations of paragraph 38.
`
`COUNT 2: [ALLEGED] INFRINGEMENT OF THE ’066 PATENT
`UNDER 35 U.S.C. §§ 271(a)-(c) and (g)
`
`39.
`
`Liquidia incorporates by reference its responses to Paragraphs 1 through 38 of the
`
`Complaint.
`
`40.
`
`41.
`
`42.
`
`43.
`
`44.
`
`45.
`
`Liquidia denies the allegations of paragraph 40.
`
`Liquidia denies the allegations of paragraph 41.
`
`Liquidia denies the allegations of paragraph 42.
`
`Liquidia denies the allegations of paragraph 43.
`
`Liquidia denies the allegations of paragraph 44.
`
`Liquidia denies the allegations of paragraph 45.
`
`- 6 -
`
`IPR2021-00406
`United Therapeutics EX2011
`Page 6 of 21
`
`

`

`Case 1:20-cv-00755-RGA-JLH Document 11 Filed 07/16/20 Page 7 of 21 PageID #: 69
`
`
`46.
`
`47.
`
`48.
`
`Liquidia denies the allegations of paragraph 46.
`
`Liquidia denies the allegations of paragraph 47.
`
`Liquidia denies the allegations of paragraph 48.
`
`COUNT 3: [ALLEGED] INFRINGEMENT OF THE ’901 PATENT
`UNDER 35 U.S.C. § 271(e)
`
`49.
`
`Liquidia incorporates by reference its responses to Paragraphs 1 through 48 of the
`
`Complaint.
`
`50.
`
`51.
`
`Liquidia denies the allegations of paragraph 50.
`
`Liquidia admits that Liquidia’s NDA included a Paragraph IV certification with
`
`respect to the ’901 patent.
`
`52.
`
`53.
`
`54.
`
`55.
`
`Liquidia denies the allegations of paragraph 52.
`
`Liquidia denies the allegations of paragraph 53.
`
`Liquidia denies the allegations of paragraph 54.
`
`Liquidia denies the allegations of paragraph 55.
`
`COUNT 4: [ALLEGED] INFRINGEMENT OF THE ’901 PATENT
`UNDER 35 U.S.C. §§ 271(a)-(c) and (g)
`
`56.
`
`Liquidia incorporates by reference its responses to Paragraphs 1 through 55 of the
`
`Complaint.
`
`57.
`
`58.
`
`59.
`
`60.
`
`61.
`
`62.
`
`Liquidia denies the allegations of paragraph 57.
`
`Liquidia denies the allegations of paragraph 58.
`
`Liquidia denies the allegations of paragraph 59.
`
`Liquidia denies the allegations of paragraph 60.
`
`Liquidia denies the allegations of paragraph 61.
`
`Liquidia denies any allegations of infringement of an unidentified and unasserted
`
`“ʼ507 patent” recited in paragraph 62. Liquidia also denies the remaining allegations of paragraph
`
`- 7 -
`
`IPR2021-00406
`United Therapeutics EX2011
`Page 7 of 21
`
`

`

`Case 1:20-cv-00755-RGA-JLH Document 11 Filed 07/16/20 Page 8 of 21 PageID #: 70
`
`
`62.
`
`63.
`
`64.
`
`65.
`
`Liquidia denies the allegations of paragraph 63.
`
`Liquidia denies the allegations of paragraph 64.
`
`Liquidia denies the allegations of paragraph 65.
`
`RESPONSE TO PLAINTIFF’S PRAYER FOR RELIEF
`
`Liquidia incorporates by reference all preceding paragraphs of this Answer as if fully set
`
`forth herein. Liquidia denies any and all allegations of patent infringement alleged in the
`
`Complaint. Liquidia denies all allegations that Plaintiff is entitled to any relief requested in
`
`paragraphs 1 – 7 of the Complaint’s Prayer for Relief, or any other relief.
`
`AFFIRMATIVE DEFENSES
`
`Pursuant to Federal Rule of Civil Procedure 8(c), and without altering any applicable
`
`burdens of proof, Liquidia asserts the following defenses to the Complaint and reserves its rights
`
`to assert additional defenses.
`
`FIRST DEFENSE – FAILURE TO STATE A CLAIM
`
`Plaintiff fails to state a claim upon which relief can be granted.
`
`SECOND DEFENSE – NON-INFRINGEMENT
`
`Liquidia does not infringe, has not infringed and will not infringe, directly or indirectly,
`
`
`
`
`
`any valid claim of the ’066 and ’901 patents.
`
`THIRD DEFENSE – INVALIDITY
`
`
`
`One or more claims of the ’066 and ’901 patents are invalid for failure to satisfy the
`
`conditions of patentability in 35 U.S.C. §§ 101 et seq., including, but not limited to §§ 101, 102,
`
`103, and/or 112. For example: (1) all of the ’066 patent claims are invalid under §§ 102 and/or
`
`103 at least over prior art PCT Application No. WO2005/007081 (“Phares”), alone or in
`
`combination with the 2004 Journal of Organic Chemistry article entitled “The Intramolecular
`
`- 8 -
`
`IPR2021-00406
`United Therapeutics EX2011
`Page 8 of 21
`
`

`

`Case 1:20-cv-00755-RGA-JLH Document 11 Filed 07/16/20 Page 9 of 21 PageID #: 71
`
`
`Asymmetric Pauson-Khand Cyclization as a Novel and General Stereoselective Route to
`
`Benzindene Prostacyclins: Synthesis of UT-15 (Treprostinil)” by R.M. Moriarty, et al.
`
`(“Moriarty”); (2) all of the ’901 patent claims are invalid under § 103 at least over prior art Phares,
`
`alone or in combination with Moriarty; (3) claims 1-7 of the ʼ066 patent are invalid under § 112
`
`as indefinite and lacking written description and enablement support at least with respect to
`
`“impurities resulting from prior alkylation and hydrolysis steps,” and at least with respect to
`
`“whereby the level of one or more impurities found in the starting batch of trepostinil is lower in
`
`the pharmaceutical composition;” (4) at least claim 3 of the ’066 patent is invalid under § 112 as
`
`indefinite and lacking written description and enablement support for reciting only sodium,
`
`potassium, and calcium, when sodium, potassium, and calcium on their own are not bases and are
`
`instead counterions that result from treatment of the treprostinil acid with the corresponding bases;
`
`and (5) all clams of the ʼ901 patent are invalid under § 112 as indefinite and lacking written
`
`description and enablement support at least with respect to the pharmaceutical batch consisting of
`
`“impurities.”
`
`FOURTH DEFENSE – PROSECUTION HISTORY ESTOPPEL
`
`
`
`Plaintiff’s claims are barred or limited from recovery, in whole or in part, by the doctrine
`
`of prosecution history estoppel.
`
`RESERVATION OF RIGHTS
`
`Liquidia hereby reserves the right to amend its Answer and reserves all defenses set out in
`
`Rule 8(c) of the Federal Rules of Civil Procedure, the Patent Laws of the United States, and other
`
`defenses, at law or in equity, which become applicable after the substantial completion of
`
`discovery or otherwise in the course of litigation.
`
`LIQUIDIA’S COUNTERCLAIMS
`
`
`
`For its counterclaims against Plaintiff United Therapeutics Corporation (“UTC”),
`
`- 9 -
`
`IPR2021-00406
`United Therapeutics EX2011
`Page 9 of 21
`
`

`

`Case 1:20-cv-00755-RGA-JLH Document 11 Filed 07/16/20 Page 10 of 21 PageID #: 72
`
`
`Counterclaim Plaintiff Liquidia Technologies, Inc. (“Liquidia”) alleges as follows:
`
`PARTIES
`
`1.
`
`Liquidia is a biopharmaceutical company focused on the development and
`
`commercialization of innovative therapeutics using its proprietary PRINT® technology to
`
`transform the lives of patients.
`
`2.
`
`Liquidia’s proposed LIQ861 product, a dry powder formulation of treprostinil was
`
`designed using Liquidia’s proprietary PRINT® technology to enhance deep-lung delivery using a
`
`convenient, palm-sized, disposable dry powder inhaler (DPI) for the treatment of pulmonary
`
`arterial hypertension (PAH). Liquidia’s proprietary PRINT® technology allows for LIQ861
`
`particles of a precise size and highly uniform shape.
`
`3.
`
`LIQ861 has the potential to maximize the therapeutic benefits of treprostinil in
`
`treating PAH by safely delivering higher doses into the lungs compared to currently approved
`
`conventional inhaled therapies, including TYVASO®. LIQ861 is also more convenient to use
`
`than currently approved inhaled therapies, including TYVASO® as LIQ861 is more conveniently
`
`administered and contained in a small carrying pouch as opposed to a nebulizer.
`
`4.
`
`Liquidia’s clinical trials of the LIQ861 product showed safe dosing of treprostinil
`
`to more than twice the maximum recommended dosage of TYVASO®, thereby providing
`
`physicians a broader dosing range to treat toward symptom relief with fewer tolerance issues than
`
`with TYVASO®, while also providing patients a more convenient treatment option, if approved.
`
`As a result of Liquidia’s investment into the development of novel treatments for PAH, resulting
`
`in LIQ861, Liquidia filed New Drug Application No. 213005 under § 505(b)(2) of the Federal
`
`Food, Drug, and Cosmetic Act (“Liquidia’s NDA”).
`
`5.
`
`Liquidia is a corporation organized and existing under the laws of the State of
`
`- 10 -
`
`IPR2021-00406
`United Therapeutics EX2011
`Page 10 of 21
`
`

`

`Case 1:20-cv-00755-RGA-JLH Document 11 Filed 07/16/20 Page 11 of 21 PageID #: 73
`
`
`Delaware, with a principal place of business at 419 Davis Drive, Suite 100, Morrisville, NC 27560.
`
`6.
`
`Upon information and belief based solely on paragraph 3 of the Complaint, UTC is
`
`a corporation organized and existing under the laws of the State of Delaware and having a place
`
`of business at 1040 Spring Street, Silver Spring, Maryland 20910.
`
`JURISDICTION
`
`7.
`
`8.
`
`Liquidia incorporates by reference paragraphs 1-6 of its Counterclaims above.
`
`These counterclaims arise under the patent laws of the United States, Title 35,
`
`United States Code. The jurisdiction of this Court is proper under at least 35 U.S.C. § 271 et seq.,
`
`and 28 U.S.C. §§ 1331, 1338, 1367, and 2201-02.
`
`9.
`
`UTC has consented to the personal jurisdiction of this Court at least by commencing
`
`its action for patent infringement in this District, as set forth in its Complaint.
`
`10.
`
`Based solely on the filing of this action, venue is proper in this District pursuant to
`
`at least 28 U.S.C. § 1400(b).
`
`COUNT I – DECLARATION OF INVALIDITY OF THE ’066 PATENT
`
`11.
`
`12.
`
`Liquidia incorporates by reference paragraphs 1-10 of its Counterclaims above.
`
`UTC alleges ownership of U.S. Patent No. 9,593,066 (the ’066 patent”) and has
`
`brought claims against Liquidia alleging infringement of the ʼ066 patent including under 35 U.S.C.
`
`§ 271(e) based upon the submission of Liquidia’s NDA to the United States Food and Drug
`
`Administration (“FDA”) seeking approval to engage in the commercial manufacture, use and/or
`
`sale of LIQ861 (treprostinil) inhalation powder (the “Liquidia Product” or “LIQ861 Product”).
`
`13.
`
`Based on the filing of UTC’s Complaint for patent infringement, an actual
`
`controversy has arisen and now exists between the parties as to the validity the ’066 patent.
`
`14.
`
`All asserted claims of the ’066 patent are invalid for failure to satisfy the conditions
`
`of patentability in 35 U.S.C. §§ 101 et seq., including, but not limited to §§ 101, 102, 103, and/or
`
`- 11 -
`
`IPR2021-00406
`United Therapeutics EX2011
`Page 11 of 21
`
`

`

`Case 1:20-cv-00755-RGA-JLH Document 11 Filed 07/16/20 Page 12 of 21 PageID #: 74
`
`
`112.
`
`15.
`
`Pursuant to the Federal Declaratory Judgment Act, 28 U.S.C. § 2201 et seq.,
`
`Liquidia requests a declaration by the Court that the claims of the ’066 patent are invalid for failure
`
`to comply with one or more of the conditions of patentability in 35 U.S.C. §§ 101 et seq., including,
`
`but not limited to §§ 101, 102, 103, and/or 112.
`
`COUNT II – DECLARATION OF NON-INFRINGEMENT OF THE ’066 PATENT
`
`16.
`
`17.
`
`Liquidia incorporates by reference paragraphs 1-15 of its Counterclaims above.
`
`UTC alleges ownership of the ’066 patent and has brought claims against Liquidia
`
`alleging infringement of the ’066 patent including under 35 U.S.C. § 271(e) based upon the
`
`submission of Liquidia’s NDA to the FDA seeking approval to engage in the commercial
`
`manufacture, use and/or sale of the Liquidia Product.
`
`18.
`
`Based on the filing of UTC’s Complaint for patent infringement, an actual
`
`controversy has arisen and now exists between the parties as to whether the manufacture, use, or
`
`sale of the Liquidia Product would infringe any valid and enforceable claim of the ’066 patent.
`
`19.
`
`The manufacture, use, or sale of the Liquidia Product would not infringe any valid
`
`and enforceable claim of the ’066 patent, either directly or indirectly.
`
`20.
`
`Pursuant to the Federal Declaratory Judgment Act, 28 U.S.C. § 2201 et seq.,
`
`Liquidia requests a declaration by the Court that the manufacture, use, or sale of the Liquidia
`
`Product would not infringe any valid and enforceable claim of the ’066 patent.
`
`COUNT III – DECLARATION OF INVALIDITY OF THE ’901 PATENT
`
`21.
`
`22.
`
`Liquidia incorporates by reference paragraphs 1-20 of its Counterclaims above.
`
`UTC alleges ownership of U.S. Patent No. 9,604,901 (“the ’901 patent”) and has
`
`brought claims against Liquidia alleging infringement of the ’901 patent including under 35 U.S.C.
`
`§ 271(e) based upon the submission of Liquidia’s NDA to the FDA seeking approval to engage in
`
`- 12 -
`
`IPR2021-00406
`United Therapeutics EX2011
`Page 12 of 21
`
`

`

`Case 1:20-cv-00755-RGA-JLH Document 11 Filed 07/16/20 Page 13 of 21 PageID #: 75
`
`
`the commercial manufacture, use and/or sale of the Liquidia Product.
`
`23.
`
`Based on the filing of UTC’s Complaint for patent infringement, an actual
`
`controversy has arisen and now exists between the parties as to the validity of the ʼ901 patent.
`
`24.
`
`All asserted claims of the ’901 patent are invalid for failure to satisfy the conditions
`
`of patentability in 35 U.S.C. §§ 101 et seq., including, but not limited to §§ 101, 102, 103, and/or
`
`112.
`
`25.
`
`Pursuant to the Federal Declaratory Judgment Act, 28 U.S.C. § 2201 et seq.,
`
`Liquidia requests a declaration by the Court that the claims of the’901 patent are invalid for failure
`
`to comply with one or more of the conditions of patentability in 35 U.S.C. §§ 101 et seq., including,
`
`but not limited to §§ 101, 102, 103, and/or 112.
`
`COUNT IV – DECLARATION OF NON-INFRINGEMENT OF THE ’901 PATENT
`
`26.
`
`27.
`
`Liquidia incorporates by reference paragraphs 1-25 of its Counterclaims above.
`
`UTC alleges ownership of the ’901 patent and has brought claims against Liquidia
`
`alleging infringement of the ’901 patent including under 35 U.S.C. § 271(e) based upon the
`
`submission of Liquidia’s NDA to the FDA seeking approval to engage in the commercial
`
`manufacture, use and/or sale of the Liquidia Product..
`
`28.
`
`Based on the filing of UTC’s Complaint for patent infringement, an actual
`
`controversy has arisen and now exists between the parties as to whether the manufacture, use, or
`
`sale of the Liquidia Product would infringe any valid and enforceable claim of the ’901 patent.
`
`29.
`
`The manufacture, use, or sale of the Liquidia Product would not infringe any valid
`
`and enforceable claim of the ’901 patent, either directly or indirectly.
`
`30.
`
`Pursuant to the Federal Declaratory Judgment Act, 28 U.S.C. § 2201 et seq.,
`
`Liquidia requests a declaration by the Court that the manufacture, use, or sale of the Liquidia
`
`Product would not infringe any valid and enforceable claim of the ’901 patent.
`
`- 13 -
`
`IPR2021-00406
`United Therapeutics EX2011
`Page 13 of 21
`
`

`

`Case 1:20-cv-00755-RGA-JLH Document 11 Filed 07/16/20 Page 14 of 21 PageID #: 76
`
`
`COUNT V – IMPROPER PATENT LISTING OF THE ’066 PATENT
`
`31.
`
`32.
`
`Liquidia incorporates by reference paragraphs 1-30 of its Counterclaims above.
`
`Upon information and belief, UTC, as the holder of New Drug Application No.
`
`022387, caused the ’066 patent to be listed in the FDA’s Approved Drug Products with Therapeutic
`
`Equivalence Evaluations publication (“Orange Book”) for TYVASO® Treprostinil Inhalation
`
`Solution 0.6mg/ml.
`
`33.
`
`The Orange Book is a publication disseminated by the FDA containing, inter alia,
`
`a listing of patents that purportedly claim drug products that have been approved for use by the
`
`FDA.
`
`34.
`
`At the time it submitted its NDA seeking approval to market the Liquidia Product,
`
`Liquidia was required by statute to submit a certification as to the ’066 patent because it is listed
`
`in the Orange Book for drug substance TYVASO® Treprostinil Inhalation Solution 0.6mg/ml.
`
`35.
`
`Liquidia submitted a Paragraph IV certification with respect to the ’066 patent
`
`under 21 U.S.C. § 355(b)(2) as part of its NDA, because Liquidia believes that the Liquidia Product
`
`would not infringe the ’066 patent and/or that the ’066 patent is invalid and/or unenforceable.
`
`36.
`
`Liquidia was required to provide UTC with notice that it had filed its NDA with a
`
`Paragraph IV certification as to the ’066 patent.
`
`37.
`
`After receiving that notice, UTC instituted this action, suing Liquidia for alleged
`
`infringement of the ’066 patent.
`
`38.
`
`Because UTC has instituted this action for alleged infringement of patents listed in
`
`the Orange Book, FDA approval of Liquidia’s NDA is stayed for the shorter of 30 months from
`
`the date UTC received notice of Liquidia’s Paragraph IV certification or the dismissal of this case.
`
`39.
`
`Pursuant to 21 C.F.R. § 314.53(b)(1), a patent containing only process claims may
`
`not be listed in the Orange Book.
`
`- 14 -
`
`IPR2021-00406
`United Therapeutics EX2011
`Page 14 of 21
`
`

`

`Case 1:20-cv-00755-RGA-JLH Document 11 Filed 07/16/20 Page 15 of 21 PageID #: 77
`
`
`40.
`
`Pursuant to 21 C.F.R. § 314.53(c)(2)(i)(L) and 21 C.F.R. § 314.53(c)(2)(ii)(M), a
`
`patent containing only product-by-process claims or a combination of process and product-by-
`
`process claims may only be listed in the Orange Book if one or more of the products claimed in
`
`the product-by-process claims is novel.
`
`41.
`
`Upon information and belief, UTC certified to the FDA that the ’066 patent is a
`
`product-by-process patent, and that the product claimed in the ’066 patent is novel, resulting in the
`
`listing of the ʼ066 patent in the Orange Book.
`
`42.
`
`The claims of the ’066 patent are all process or product-by-process claims. Claims
`
`1 and 8 of the ʼ066 patent are independent claims. Claims 8 and 10 of the ’066 patent are process
`
`claims. The remaining eight claims of the ’066 patent are product-by-process claims.
`
`43.
`
`Claim 1 of the ’066 patent recites “[a] pharmaceutical composition comprising
`
`treprostinil or a pharmaceutically acceptable salt thereof, said composition prepared by a process
`
`comprising” several steps.
`
`44.
`
`Claim 8 of the ’066 patent recites “[a] process of preparing a pharmaceutical
`
`product comprising treprostinil or a pharmaceutically acceptable salt thereof.”
`
`45.
`
`PCT Application No. WO2005/007081 (“Phares”) is titled “Compounds and
`
`Methods for Delivery of Prostacyclin Analogs.” The named inventors are Ken Phares and David
`
`Mottola. Phares was published January 27, 2005, more than two years before the earliest U.S.
`
`application to which the ’066 patent can claim priority. Phares describes “compounds and methods
`
`for inducing prostacyclin-like effects in a subject or patient,” including treprostinil and derivatives
`
`thereof.
`
`46.
`
`The article titled “The Intramolecular Asymmetric Pauson-Khand Cyclization as a
`
`Novel and General Stereoselective Route to Benzindene Prostacyclins: Synthesis of UT-15
`
`- 15 -
`
`IPR2021-00406
`United Therapeutics EX2011
`Page 15 of 21
`
`

`

`Case 1:20-cv-00755-RGA-JLH Document 11 Filed 07/16/20 Page 16 of 21 PageID #: 78
`
`
`(Treprostinil)” was authored by R.M. Moriarty, et al. (“Moriarty”). It was published in 2004 in
`
`the Journal of Organic Chemistry, Volume 69, No. 6, pp. 1890-1902, more than two years before
`
`the earliest U.S. application to which the ’066 patent can claim priority.
`
`47.
`
`The product of the ’066 patent is not novel because a pharmaceutical batch
`
`comprising treprostinil as claimed in the ʼ066 patent was disclosed in the prior art, including Phares
`
`and Moriarty.
`
`48.
`
`UTC listed the ʼ066 patent in the Orange Book on March 14, 2017. On March 31,
`
`2017, UTC was made aware that the product claimed in the ʼ066 patent was not novel, as the Patent
`
`Trial and Appeal Board issued its Final Written Decision in IPR2016-00006 involving UTC’s U.S.
`
`Patent No. 8,497,393, finding that the product claimed in the ʼ393 patent was not novel over the
`
`prior art. That decision was affirmed by the Federal Circuit. The ʼ393 and ʼ066 patents share the
`
`same specifications and disclose and claim the same product.
`
`49.
`
`UTC improperly listed the ’066 patent in the Orange Book for TYVASO® because
`
`the ’066 patent only consists of process claims and product-by-process claims directed to a non-
`
`novel product.
`
`50.
`
`UTC has knowingly maintained the improper listing of the ʼ066 patent in the
`
`Orange Book.
`
`51.
`
`FDA approval of the Liquidia Product should not be delayed as a result of the
`
`improper listing of the ’066 patent.
`
`52.
`
`Pursuant to 21 U.S.C. § 355(j)(5)(C)(ii), UTC should be ordered to delete or delist
`
`the ’066 patent from the Orange Book’s listing for TYVASO®.
`
`COUNT VI – IMPROPER PATENT LISTING OF THE ’901 PATENT
`
`53.
`
`54.
`
`Liquidia incorporates by reference paragraphs 1-52 of its Counterclaims above.
`
`Upon information and belief, UTC, as the holder of New Drug Application No.
`
`- 16 -
`
`IPR2021-00406
`United Therapeutics EX2011
`Page 16 of 21
`
`

`

`Case 1:20-cv-00755-RGA-JLH Document 11 Filed 07/16/20 Page 17 of 21 PageID #: 79
`
`
`022387, caused the ’901 patent to be listed in the Orange Book for TYVASO® Treprostinil
`
`Inhalation Solution 0.6mg/ml.
`
`55.
`
`The Orange Book is a publication disseminated by the FDA containing, inter alia,
`
`a listing of patents that purportedly claim drug products that have been approved for use by the
`
`FDA.
`
`56.
`
`At the time it submitted its NDA seeking approval to market the Liquidia Product,
`
`Liquidia was required by statute to submit a certification as to the ’901 patent because it is listed
`
`in the Orange Book for drug substance TYVASO® Treprostinil Inhalation Solution 0.6mg/ml.
`
`57.
`
`Liquidia submitted a Paragraph IV certification with respect to the ’901 patent
`
`under 21 U.S.C. § 355(b)(2) as part of its NDA, because Liquidia believes the Liquidia Product
`
`would not infringe the ’901 patent and/or that the ’901 patent is invalid and/or unenforceable.
`
`58.
`
`Liquidia was required to provide UTC with notice that it had filed its NDA with a
`
`Paragraph IV certification as to the ’901 patent.
`
`59.
`
`Upo