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UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`
`
`LIQUIDIA TECHNOLOGIES, INC.,
`Petitioner
`
`v.
`
`UNITED THERAPEUTICS CORPORATION,
`Patent Owner
`
`
`
`
`Case No. IPR2021-00406
`U.S. Patent No. 10,716,793
`
`
`
`
`PETITIONER’S UPDATED EXHIBIT LIST
`
`
`
`
`
`
`
`
`
`
`
`
`

`

`IPR2021-00406
`U.S. Patent No. 10,716,793
`
`
`
`
`Description of Document
`
`Exhibit
`No.
`1001 U.S. Patent No. 10,716,793 B2 to Olschewski, et al. (“’793 patent”)
`1002 Declaration of Dr. Nicholas Hill (“Hill Decl.”)
`1003 Curriculum Vitae of Dr. Nicholas Hill
`1004 Declaration of Dr. Igor Gonda (“Gonda Decl.”)
`1005 Curriculum Vitae of Dr. Igor Gonda
`1006 U.S. Patent No. 6,521,212 B1 to Cloutier, et al. (“’212 patent”)
`1007 Voswinckel, R., et al., Abstract 218: “Inhaled treprostinil is a potent
`pulmonary vasodilator in severe pulmonary hypertension,” European
`Heart Journal 25:22 (2004) (“Voswinckel JESC”)
`1008 Robert Voswinckel, Beate Enke, Andre Kreckel, Frank
`Reichenberger, Stefanie Krick, Henning Gall, Tobias Gessier, Thomas
`Schmehl, Markus G. Kohstall, Friedrich Grimminger, Hossein A.
`Ghofrani, Werner Seeger, and Horst Olschewski, Abstract 1414:
`“Inhaled Treprostinil Sodium (TRE) For the Treatment of Pulmonary
`Hypertension,” Abstracts from the 2004 Scientific Sessions of the
`American Heart Association, Circulation, 110(17 Suppl.):III-295
`(October 26, 2004) (“Voswinckel JAHA”)
`1009 Robert Voswinckel, Hossein A. Ghofrani, Friedrich Grimminger, and
`Werner Seeger, “Clinical Observations” on “Inhaled Treprostinil for
`Treatment of Chronic Pulmonary Arterial Hypertension,” “Letters”
`Section of the Annals of Internal Medicine, 144(2):149-50 (January
`2006) (“Voswinckel 2006”)
`1010 Hossein Ardeschir Ghofrani, Robert Voswinckel, et al., Neue
`Therapieoptionen in der Behandlung der pulmonalarteriellen
`Hypertonie, 30(4) HERZ, 30(4):296–302 (June 2005) (“Ghofrani”)
`(Foreign article and English translation attached)
`First Amended Complaint filed in United Therapeutics Corporation
`v. Liquidia Technologies, Inc., Case No. 1:20-cv-00755-RGA (D.
`Del.)
`
`1011
`
`
`
`1
`
`

`

`IPR2021-00406
`U.S. Patent No. 10,716,793
`
`
`Exhibit
`Description of Document
`No.
`1012 United Therapeutics Corporation’s Answer to Defendant Liquidia
`Technologies, Inc.’s Counterclaims filed in United Therapeutics
`Corporation v. Liquidia Technologies, Inc., Case No. 1:20-cv-00755-
`RGA (D. Del.)
`1013 United Therapeutics Corporation’s Opening Brief in Support of its
`Motion to Dismiss Defendant’s Counterclaim filed in United
`Therapeutics Corporation v. Liquidia Technologies, Inc., Case No.
`1:20-cv-00755-RGA (D. Del.)
`1014 Memorandum Order denying United Therapeutics Corporation’s
`Motion to Dismiss Defendants Counterclaim filed in United
`Therapeutics Corporation v. Liquidia Technologies, Inc., Case No.
`1:20-cv-00755-RGA (D. Del.)
`
`10,716,793 Patent Prosecution History
`
`10,376,525 Patent Prosecution History (excerpted)
`
`1015
`1016
`1017
`9,339,507 Patent Prosecution History (excerpted)
`1018 Remodulin® 2004 Label
`Stein, S.W., et al., “The History of Therapeutic Aerosols: A
`1019
`Chronological Review,” Journal of Aerosol Medicine and
`Pulmonary Drug Delivery, 30(1):20-41 (2017) (“Stein”)
`1020 Clark, A.R., “Medical Aerosol Inhalers: Past, Present, and Future,”
`Aerosol Science and Technology, 22:374-91 (1995) (“Clark”)
`1021 Ruan, C.-H., et al., “Prostacyclin Therapy for Pulmonary Arterial
`Hypertension,” Texas Heart Institute Journal, 37(4):391-99 (2010)
`(“Ruan”)
`1022 Walmrath, D., et al., “Direct Comparison of Inhaled Nitric Oxide and
`Aerosolized Prostacyclin in Acute Respiratory Distress Syndrome,”
`American Journal of Respiratory Critical Care Medicine, 153:991-
`96 (1996) (“Walmrath 1996”)
`1023 Olschewski, H., et al., “Inhaled Prostacyclin and Iloprost in Severe
`Pulmonary Hypertension Secondary to Lung Fibrosis,” American
`
`
`
`2
`
`

`

`IPR2021-00406
`U.S. Patent No. 10,716,793
`
`
`Exhibit
`No.
`
`Description of Document
`Journal of Respiratory Critical Care Medicine, 160:600-07 (1999)
`(“Olschewski 1999”)
`1024 Haché, M., et al., “Inhaled epoprostenol (prostacyclin) and
`pulmonary hypertension before cardiac surgery,” Journal of
`Thoracic and Cardiovascular Surgery, 125:642-49 (2003) (“Hache”)
`1025 De Wet, C.J., et al., “Inhaled prostacyclin is safe, effective, and
`affordable in patients with pulmonary hypertension, right heart
`dysfunction, and refractory hypoxemia after cardiothoracic surgery,”
`Journal of Thoracic and Cardiovascular Surgery, 127:1058-67
`(2004) (“De Wet”)
`1026 Denver, J. and Dyche, T., “The Adaptive Aerosol Delivery (AAD)
`Technology: Past, Present, and Future,” Journal of Aerosol Medicine
`and Pulmonary Drug Delivery, 23(1 suppl):S-1-S10 (2010) (“Denver
`and Dyche”)
`1027 U.S. Patent No. 6,242,482 B1 to Shorr, et al. (“Shorr”)
`1028 U.S. Patent Application Publication No. US 2004/0265238 A1 to
`Chaudry (“Chaudry”)
`1029 Ventavis® Label 2004
`1030 Newman, S.P., “Aerosols”, Chapter from Encyclopedia of
`Respiratory Medicine pp. 58-64 (2006) (“Newman”)
`1031 Geller, D.E., “Comparing Clinical Features of the Nebulizer,
`Metered-Dose Inhaler, and Dry Powder Inhaler,” Respiratory Care,
`50(10):1313-21 (2005) (“Geller 2005”)
`1032 Bender, B., et al., “Nonadherence in asthmatic patients: is there a
`solution to the problem?” Annals of Allergy, Asthma & Immunology,
`79:177-86 (1997) (“Bender 1997”)
`1033 Rau, J.L., “Determinants of Patient Adherence to an Aerosol
`Regimen,” Respiratory Care 50(10):1346-56 (2005) (“Rau 2005”)
`1034 Geller, D., et al., “Bolus Inhalation of rhDNase with the AERx
`System in Subjects with Cystic Fibrosis,” Journal of Aerosol
`
`
`
`3
`
`

`

`IPR2021-00406
`U.S. Patent No. 10,716,793
`
`
`Exhibit
`No.
`
`Description of Document
`Medicine, 16(2):175-82 (2003) (“Geller 2003”)
`1035 Chattaraj, S.C., “Treprostinil sodium Pharmacia,” Current Opinion
`in Investigational Drugs, 3(4):582-86 (Apr. 2002), available at
`https://pubmed.ncbi.nlm.nih.gov/12090728/ (“Chattaraj”)
`1036 Declaration of Sylvia Hall-Ellis, Ph.D. (“Hall-Ellis Decl.”)
`1037
`English translation of OptiNeb® User Manual 2005
`1038 Atkins, P.J., “Dry Powder Inhalers: An Overview,” Respiratory
`Care, 50(10):1304-12 (2005) (“Atkins”)
`Frijlink, H.W. and De Boer, A.H., “Dry powder inhalers for
`pulmonary drug delivery,” Expert Opinion on Drug Delivery,
`1(1):67-86 (2004) (“Frijlink and De Boer”)
`1040 Chew N. and Chan H.-K., “Pharmaceutical Dry Powder Aerosol
`Delivery,” KONA, No. 19, pp. 46-56 (2001) (Chew and Chan)
`
`1039
`
`1041
`1042
`
`1043
`
`Reserved
`January 27, 2020 Press Release, “Liquidia Submits New Drug
`Application for LIQ861 (Treprostinil) Inhalation Powder to U.S.
`Food And Drug Administration for the Treatment of Pulmonary
`Arterial Hypertension (PAH),” available at
`https://investors.liquidia.com/news-releases/news-release-
`details/liquidia-submits-new-drug-application-liq861-treprostinil
`2009 Tyvaso® Label, available at
`https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022387s
`015lbl.pdf
`
`9,358,240 Patent Prosecution History (excerpted)
`
`1044
`1045
`Reserved
`1046 U.S. Patent No. 9,358,240 to Olschewski, et al. (“’240 Patent”)
`1047 Hoeper, M.M., et al., “Long-Term Treatment of Primary Pulmonary
`Hypertension with Aerosolized Iloprost, a Prostacyclin Analogue,” N
`
`
`
`4
`
`

`

`IPR2021-00406
`U.S. Patent No. 10,716,793
`
`
`Exhibit
`No.
`
`Description of Document
`Engl J Med, 342:1866-70 (2000) (“Hoeper”)
`1048 Walmrath, D., et al., “Aerosolised prostacyclin in adult respiratory
`distress syndrome,” Lancet, 342:961-62 (1993) (“Walmrath 1993”)
`1049 April 8, 2020 Press Release, “Liquidia Announces FDA Acceptance
`of New Drug Application for LIQ861 (Treprostinil) Inhalation
`Powder for the Treatment of Pulmonary Arterial Hypertension,”
`available at https://investors.liquidia.com/news-releases/news-
`release-details/liquidia-announces-fda-acceptance-new-drug-
`application-liq861
`
`1050
`1051
`
`Pulmozyme® Label
`Farber, H.W. and Loscalzo, J., “Pulmonary Arterial Hypertension,”
`N Engl J Med, 351:1655-65 (2004) (“Farber and Loscalzo”)
`1052 Rubin, L.J. and Badesch, D.B., “Evaluation and Management of the
`Patient with Pulmonary Arterial Hypertension,” Ann Intern Med.,
`143:282-92 (2005) (“Rubin and Badesch”)
`
`1053
`Flolan® Label
`1054 Gonda, I., “A semi-empirical model of aerosol deposition in the
`human respiratory tract for mouth inhalation,” J. Pharm.
`Pharmacol., 33:692-96 (1981) (“Gonda 1981”)
`1055 Gonda, I., “Study of the effects of polydispersity of aerosols on
`regional deposition in the respiratory tract,” J. Pharm. Pharmacol.,
`33 (Suppl.) 52P (1981) (“Gonda 1981b”)
`Telko, M.J. and Hickey, A.J., “Dry Powder Inhaler Formulation,”
`Respiratory Care, 50(9):1209-27 (2005) (“Telko and Hickey”)
`1057 October 24, 2005 Press Release, “Aradigm Corporation And United
`Therapeutics Corporation Sign Development and Commercialization
`Agreement Targeting Pulmonary Hypertension,” available at
`https://www.biospace.com/article/releases/aradigm-corporation-and-
`united-therapeutics-corporation-sign-development-and-
`commercialization-agreement-targeting-pulmonary-hypertension-/
`
`1056
`
`
`
`5
`
`

`

`IPR2021-00406
`U.S. Patent No. 10,716,793
`
`
`Exhibit
`No.
`1058
`
`1060
`
`Description of Document
`Ziegler, J. and Wachtel, H., “Comparison of Cascade Impaction and
`Laser Diffraction for Particle Size Distribution Measurements,”
`Journal of Aerosol Medicine, 18(3):311-24 (2005) (“Ziegler and
`Wachtel”)
`1059 Nauser, T.D., “Pulmonary Hypertension: New Perspectives,” CHF,
`9:155-62 (2003) (“Nauser 2003”)
`Pitcairn, G., et al., “Deposition of Corticosteroid Aerosol in the
`Human Lung by Respimat® Soft Mist™ Inhaler Compared to
`Deposition by Metered Dose Inhaler or by Turbuhaler® Dry Powder
`Inhaler,” Journal of Aerosol Medicine, 18(3):264-72 (2005)
`(“Pitcairn”)
`1061 Dalby, R., et al., “A review of the development of Respimat® Soft
`MistTM Inhaler,” International Journal of Pharmaceutics, 283:1-9
`(2004) (“Dalby”)
`1062 Gessler, T., et al., “Ultrasonic versus jet nebulization of iloprost in
`severe pulmonary hypertension,” Eur Respir J, 17:14-19 (2001)
`(“Gessler”)
`
`1063
`Reserved
`1064 Dolovich, M.B., et al., “Device Selection and Outcomes of Aerosol
`Therapy: Evidence-Based Guidelines,” CHEST, 127:335-71 (2005)
`(“Dolovich”)
`1065 Olschewski, H., et al., “Inhaled Iloprost for Several Pulmonary
`Hypertension,” N Engl J Med, 347(5):322-29 (2002) (“Olschewski
`2002”)
`1066 AccuNeb® Label
`1067 Anderson, P.J., “History of Aerosol Therapy: Liquid Nebulization to
`MDIs to DPIs,” Respiratory Care, 50(9):1139-49 (2005) (“Anderson
`2005”)
`1068 Vachiéry, J.-L., et al., “Transitioning From IV Epoprostenol to
`Subcutaneous Treprostinil in Pulmonary Arterial Hypertension,”
`CHEST, 121:1561-65 (2002) (“Vachiéry 2002”)
`
`
`
`6
`
`

`

`IPR2021-00406
`U.S. Patent No. 10,716,793
`
`
`Exhibit
`No.
`1069
`
`Description of Document
`Zierenberg, B. and Eicher, J., Chapter 78 “The Respimat, a New Soft
`Mist Inahler for Delivering Drugs to The Lungs,” MODIFIED-
`RELEASE DRUG DELIVERY TECHNOLOGY (2002) pp.925-933
`(“Zierenberg”)
`1070 Beasley, R., et al., “Preservatives in Nebulizer Solutions: Risks
`without Benefit,” Pharmacotherapy, 18(1):130-39 (1998)
`(“Beasley”)
`Prober, C.G., et al., “Technical Report: Precautions Regarding the
`Use of Aerosolized Antibiotics,” Pediatrics, 106(6):1-6 (2000)
`(“Prober”)
`
`1071
`
`1072
`Reserved
`1073 Aradigm Corporation Form 10-Q for the quarterly period ended June
`30, 2009, available at
`https://www.sec.gov/Archives/edgar/data/1013238/00009501230903
`1361/f53244e10vq.htm
`1074 Orenitram® Label, available at
`https://www.orenitram.com/pdf/Orenitram-Prescribing-
`Information.pdf
`1075 November 17, 2008 Press Release, “Eli Lilly and Company Licenses
`U.S. Rights for Tadalafil PAH Indication to United Therapeutics
`Corporation,” available at
`https://www.fiercebiotech.com/biotech/eli-lilly-and-company-
`licenses-u-s-rights-for-tadalafil-pah-indication-to-united
`1076 October 23, 2017 Press Release, “United Therapeutics Announces
`FDA Approval Of Third Generation Nebulizer For The Tyvaso®
`Inhalation System,” available at https://www.prnewswire.com/news-
`releases/united-therapeutics-announces-fda-approval-of-third-
`generation-nebulizer-for-the-tyvaso-inhalation-system-
`300540953.html
`1077 Boyle, M.P., “So Many Drugs, So Little Time. The Future Challenge
`of Cystic Fibrosis Care,” CHEST, 123(1):3-5 (2003) (“Boyle 2003”)
`
`
`
`7
`
`

`

`IPR2021-00406
`U.S. Patent No. 10,716,793
`
`
`Description of Document
`
`Exhibit
`No.
`1078 Azmacort® Label 2003
`1079 Hill, N.S., et al., “Inhaled Therapies for Pulmonary Hypertension,”
`Respiratory Care, 60(6):794-805 (2015) (“Hill 2015”)
`1080 Declaration of Deepa Kannappan in Support of Motion for Pro Hac
`Vice Admission
`1081 Biography of Deepa Kannappan
`
`
`
`Dated: April 15, 2021
`
`COOLEY LLP
`ATTN: Patent Group
`1299 Pennsylvania Avenue NW
`Suite 700
`Washington, D.C. 20004
`Tel: (212) 479-6840
`Fax: (212) 479-6275
`
`
`
`
`
`
`
`
`By:
`
`
`
`
`Respectfully submitted,
`
`
`/Ivor R. Elrifi/
`Ivor R. Elrifi
`Reg. No. 39,529
`Counsel for Petitioner
`
`
`
`8
`
`

`

`IPR2021-00406
`U.S. Patent No. 10,716,793
`
`
`
`
`CERTIFICATE OF SERVICE
`
`Pursuant to 37 C.F.R. §§42.6(e)(4)(i) et seq., a complete copy of the attached
`PETITIONER’S UPDATED EXHIBIT LIST and related documents are being
`served via email on the 15th day of April 2021, upon Patent Owner’s attorneys of
`record:
`
`UT-793@foley.com
`Stephen B. Maebius (smaebius@foley.com)
`George Quillin (gquillin@foley.com)
`Daniel R. Shelton (dshelton@foley.com)
`FOLEY & LARDNER LLP
`
`Douglas Carsten (dcarsten@mwe.com)
`April E. Weisbruch (aweisbruch@mwe.com)
`Judy Mohr (jmohr@mwe.com)
`MCDERMOTT WILL & EMERY LLP
`
`Richard Torczon (rtorczon@wsgr.com)
`Grace A. Winschel (gwinschel@wsgr.com)
`WILSON, SONSINI, GOODRICH & ROSATI
`
`Shaun R. Snader (ssnader@unither.com)
`UNITED THERAPEUTICS CORP.
`
`
`
`
`By:
`
`
`
`
`
`/Ivor R. Elrifi/
`Ivor R. Elrifi
`Reg. No. 39,529
`Counsel for Petitioner
`
`
`
`Dated: April 15, 2021
`
`COOLEY LLP
`ATTN: Patent Group
`1299 Pennsylvania Avenue NW
`Suite 700
`Washington, D.C. 20004
`Tel: (212) 479-6840
`Fax: (212) 479-6275
`
`
`
`
`
`
`
`
`9
`
`

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