Liquidia Technologies, Inc. vs United Therapeutics Corporation

Other: other court decision

Other: Fed Circuit mandate

Other: other court decision

Other: other court decision

Patent Owner's Notice of Appeal

Final Written Decision: Denying Patent Owners Request on Rehearing of Final Written Decision 37 C.F.R. sec. 42.71d

Order: Denying POP Request

Ex. 3003

Notice: notice of receipt of POP request

Patent Owner's Request for Rehearing

Final Written Decision: original

Other: Hearing transcript

Order Conduct of the Proceeding

Email

Petitioner's Updated Exhibit List

Petitioner's Demonstrative Exhibit

Patent Owner's Updated Exhibit List

EX2109 Patent Owner's Demonstrative Exhibits

Joint Errata

Liquidia's Reply ISO Motion to Exclude

Patent Owner's Reply in Support of Its Motion to Exclude

Petitioner's Opposition to Patent Owner's Motion to Exclude

Patent Owner's Opposition to Petitioner's Motion to Exclude

Patent Owner's Updated Exhibit List

Exhibit 2105 DiNatale Declaration

Exhibit 2106 Frank-White (Internet Archive) Declaration

Exhibit 2107 Revilla Declaration

Order Setting Oral Argument

Petitioner's Motion to Exclude Exhibits

Patent Owner's Motion to Exclude Evidence

Petitioner's Observations on the Cross-Examination of Dr. Hill

Patent Owner's Observations on April 13, 2022 Deposition of Dr. Hill

EX2108 - Hill Depo Transcript with ex. 1086 (4-13-22)

Patent Owner's Identification of Portions of Petitioner's Reply to Which Identified Sur-Reply Evidence and Arguments Are Responsive

Patent Owner's Notice of Deposition of Nicholas S. Hill, M.D.

Petitioner's Identification of Exhibits and Portions of PO's Sur-Reply that Exceed the Scope of Allowable Sur-Reply Evidence

Patent Owner's Updated Exhibit List

Patent Owner's Request for Oral Argument

Petitioner's Request for Oral Hearing

Petitioner's Objections to Evidence

Order: Conduct of Proceeding

Patent Owner's Unopposed Third Motion to File Under Seal

Ex 2094 - Hall-Ellis Deposition with Exs. 2092 and 2093

Ex 2095 - Butler Deposition

Ex 2096 - Hill Deposition (D. Del.)

Ex 2097 - Gonda Deposition (D. Del.)

Ex 2099 - Gonda Deposition

Ex 2100 - Schill: Multisonic, Inhaling with ultrasonic infraControl (2004)

Ex 2101 - Schill: Multisonic, Inhaling with ultrasonic infraControl

Ex 2102 - DeVilbiss, UltraNeb, Ultrasonic Nebulizer manual

Ex 2103 - Lieberman, In Vitro Performance of the MyNeb(R) Nebulizer

Ex 2104 - Telephonic Hearing Transcript (March 1, 2022)

Patent Owner Sur-Reply

Patent Owner's Notice of Deposition of Christopher Butler Under 37 C.F.R. Sec. 42.53

Patent Owner's Notice of Deposition of Dr. Sylvia Hall-Ellis Under 37 C.F.R. Sec. 42.53

Order: Conduct of the Proceeding - 37 CFR 42.5

Joint Stipulation to Extend Due Date

Petitioner's Identification of Portions of Patent Owner's Response to Which Identified Reply Evidence and Arguments Are Responsive

Patent Owner's Identification of Non-Responsive Evidence and Arguments

Patent Owner's Objections to Petitioner's Evidence Submitted with Petitioner Reply

Petitioner's Unopposed Motion to File Under Seal

Transcript from the January 15, 2022 deposition of Aaron B. Waxman, M.D., Ph.D., United Therapeutics Corp. v. Liquidia Technologies, Inc., Case No. 1:20-cv-00755 (D. Del.) (excerpted)

Petitioner's Reply in Support of Petition

Petitioner's Updated Exhibit List

Butler Affidavit

Tyvaso�� Label 2021 (Note: PO���s Ex. 2034, described as ���Tyvaso�� Label 2021,��� is the 2009 label)

Voswinckel JESC, UWash

Voswinckel JESC, UWisc

Voswinckel JESC, British Library

Voswinckel JESC, Additional Pages

Voswinckel JAHA, British Library

Voswinckel JAHA, Library of Congress

Voswinckel JAHA, Stanford

Voswinckel JAHA, UC Davis

Rhind, G.B. et al., ���Effect of Spirometry of Distilled Water and Cromoglycate Solutions Nebulised by a Small Portable Ultrasonic Nebuliser,��� Respiration, 51:86-90 (1987)

Hager, J., et al., ���Measurement of Particle and Mass Distribution of Pentamidine Aerosol by Ultrasonic and Air Jet Nebulizers,��� Journal of Aerosol Medicine, Vol. 5, No. 2 (1992)

Leigh, T.R., et al., ���Performance characteristics of the DeVilbiss Ultraneb 99 ultrasonic nebuliser with reference to use in sputum induction,��� International Journal of Pharmaceutics, 67 (1991) 275-282

Ventavis EU Summary of Product Characteristics

Byrne, N.M., et al., ���Comparison of lung deposition of colomycin using the HaloLite and the Pari LC Plus nebulisers in patients with cystic fibrosis,��� Arch Dis Child 2003;88:715���718

Leung, K., et al., ���Comparison of Breath-Enhanced to Breath-Actuated Nebulizers for Rate, Consistency, and Efficiency,��� CHEST 2004; 126:1619���1627

Sulica, R. and Poon, M., ���Medical therapeutics for pulmonary arterial hypertension: from basic science and clinical trial design to evidence-based medicine,��� Expert Rev. Cardiovasc. Ther. 3(2), (2005)

European Society of Cardiology Annual Report 2005

Reply Declaration of Nicholas Hill, M.D.

Reply Declaration of Igor Gonda, Ph.D.

Transcript from the January 8, 2022 Deposition of Aaron Waxman, M.D., Ph.D., Liquida Technologies, Inc. v. United Therapeutics Corp., IPR2021-00406

Transcript from the January 11, 2022 Deposition of Jason McConville, Liquida Technologies, Inc. v. United Therapeutics Corp., IPR2021-00406

Transcript from the December 29, 2021 Deposition of Lyndsey Pilar Wyman, Liquida Technologies, Inc. v. United Therapeutics Corp., IPR2021-00406

Denyer, J., et al., ���Adaptive Aerosol Delivery (AAD��) technology,��� Expert Opinion on Drug Delivery, 1:1, 165-176

Reply Declaration of Sylvia Hall-Ellis Ph.D.

Voswinckel JAHA Supplemental Author Index

Am. Heart Assn 2004 Online Archive Websites (too large to list)

Affidavit of Duncan Hall, December 7, 2021

Voswinckel JAHA British Library Declaration

Voswinckel JAHA Supplement PubMed Search Results

PubMed.gov search results for Sulica, R. and Poon, M., ���Medical therapeutics for pulmonary arterial hypertension: from basic science and clinical trial design to evidence-based medicine,��� Expert Rev. Cardiovasc. Ther. 3(2), (2005)

Voswinckel JESC British Library Declaration

Voswinckel JESC Web of Science Search Results

Ghofrani 2005, British Library

Ghofrani 2005 Search Results

Circulation MARC record, British Library

Circulation MARC record, Library of Congress

Circulation MARC record, Stanford

Circulation MARC record, UC Davis

European Heart Journal bibliographic record, UWash

European Heart Journal MARC record, UWisc

European Heart Journal MARC record, British Library

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),���

Michael Mellon et al., Comparable Efficacy of Administration with Face Mask or Mouthpiece of Nebulized Budesonide Inhalation Suspension for Infants and Young Children with Persistent Asthma, 162 AM. J. RESPIR. CARE MED. 593 (2000)

Granting Patent Owner's Motion for Pro Hac Vice Admission of Mandy Kim

Granting Petitioner's Motion for Pro Hac Vice Admission of Jonathan Davies

Patent Owner's Updated Mandatory Notices Under 37 C.F.R. Section 42.8

Patent Owner's Updated Exhibit List

Patent Owner's Unopposed Motion for Pro Hac Vice Admission of Mandy Kim Under 37 C.F.R. Sec. 42.10(c)

Ex 2092 Biography of Mandy Kim

Ex 2093 Declaration of Mandy Kim

Petitioner's Updated Power of Attorney

Petitioner's Updated Mandatory Notice re Additional Backup Counsel

Petitioner's Unopposed Motion for Pro Hac Vice Admission for Jonathan Davies

Biography of Jonathan Davies

Declaration of Jonathan Davies ISO Motion for Pro Hac Vice Admission

Petitioner's Updated Exhibit List

Petitioner's Notice of Deposition of Pilar Wyman

Liquidia's Updated Power of Attorney

Liquidia's Updated Mandatory Notice

Order: Denying Petitioners Request for Authorization to File Motion to Submit Supplemental Information

Patent Owner's Motion to File Under Seal

Exhibit 2062

Exhibit 2063

Exhibit 2064

Ex 2037 - Springer website (from fn 13 of Hall-Ellis Decl)

Ex 2039 - Springer website (from fn 14 of Hall-Ellis Decl)

Ex 2040 - JAHA Holdings at UWM Library

Ex 2041 - Declaration of Ms. Pilar Wyman

Ex 2042 - Pilar Wyman���s curriculum vitae

Ex 2043 - Deposition of Sylvia Hall-Ellis PhD

Ex 2044 - AHA Listing of Circulation Supplements

Ex 2045 - Chemical Abstracts Plus Transcript

Ex 2046 - Ovid Search Results for Voswinckel

Ex 2047 - PubMed Search Results for Voswinckel

Ex 2048 - Descriptor Terms Search Results Compilation

Ex 2049 - Oxford Academic Listing of EHJ Supplements

Ex 2050 - Simonneau (2013)

Ex 2051 - Sitbon (2017)

Ex 2054 - Dr. McConville's curriculum vitae

Ex 2055 - Deposition of Dr. Nicholas Hill

Ex 2056 - Deposition of Igor Gonda, Ph.D.

Ex 2057 - Hopkins Medicine Vital Signs

Ex 2058 - Pharmacokinetics of Inhaled Drugs

Ex 2060 - Waxman_Inhaled_Treprostinil_Paper

Ex 2061 - Roscigno Declaration (2018)

Ex 2065 - Seeger Declaration (2009)

Ex 2066 - Seeger Declaration (2017)

Ex 2067 - Ghofrani Decl (2017)

Ex 2068 - Reichenberger Declaration

Ex 2069 - Grimminger Declaration

Ex 2070 - Seeger Declaration (2015)

Ex 2071 - Seeger Declaration (2018)

Ex 2072 - Services Agreement

Ex 2073 - Action Items from Meeting

Ex 2074 - Ghofrani Declaration (2018)

Ex 2075 - Brun (2000)

Ex 2076 - Kendrick (1997)

Ex 2077 - Rau (2004)

Ex 2078 - Rau (2005)

Ex 2079 - Hess (1996)

Ex 2080 - FDA Guidance 2002

Ex 2081 - Newman (1996)

Ex 2082 - Dubus (2005)

Ex 2083 - Treprostonil (Pub Chem)

Ex 2084 - Roscigno (2020)

Ex 2085 - Roscigno (2021)

Ex 2086 Part 1 - Declaration of Dr. Roham T. Zamanian

Ex 2086 Part 2 - Declaration of Dr. Roham T. Zamanian

Ex 2087 - Sandifer (2005)

Ex 2088 - U.S. Patent Publ No. 2012/0177693 (Cipolla)

Ex 2089 - Liquidia 2020 10-K Form

Ex 2090 - Preston (2014)

Ex 2036 - McLaughlin (2003)

Ex 2053 - Declaration of Dr. Jason McConville

Ex 2052 - Second Declaration of Dr. Aaron Waxman

Ex 2091 - Expert Report of Dr. Igor Gonda (D. Del) (excerpts)

Ex 2052 - [PUBLIC] Second Declaration of Dr. Aaron Waxman

Patent Owner Second Motion to File Under Seal

EXPUNGED

Patent Owner Response

Patent Owner's Updated Mandatory Notices

Joint Stipulation to Extend Due Dates

Patent Owner���s Notice Of Deposition Of Dr. Igor Gonda Under 37 C.F.R. �� 42.53

Patent Owner's Notice Of Deposition Of Nicholas S. Hill, M.D. Under 37 C.F.R. 42.53

Patent Owner���s Notice Of Deposition Of Dr. Sylvia Hall-Ellis Under 37 C.F.R. �� 42.53

Patent Owner's Updated Mandatory Notices

Patent Owner's Objections to Petitioner's Evidence Submitted with Petition

Granting Institution of Inter Partes Review

SCHEDULING ORDER

Petitioner's Response to PO's Notice of Supplemental Authority and Stipulation

Patent Owner's Notice of Supplemental Authority & Stipulation

PANEL CHANGE ORDER Conduct of the Proceedings 37 C.F.R. �� 42.5

Patent Owner's Updated Mandatory Notices

Patent Owner's Preliminary Response

EX2001 - Declaration of Dr. Aaron Waxman

EX2002 - Dr. Waxman's CV

EX2003 - Declaration of Dr. Werner Seeger

EX2004 - Declaration of Dr. Hossein A. Ghofrani

EX2005 - Declaration of Dr. Frank Reichenberger

EX2006 - Declaration of Dr. Friedrich Grimminger

EX2007 - Tyvaso Orange Book listing

EX2008 - Hill, 2005, Therapeutic Options

EX2009 - Substantive Submission filed in 12/591,200 (Mar. 9, 2015)

EX2010 - UT v. Liquidia, D. Del., ECF-1

EX2011 - UT v. Liquidia, D. Del., ECF 11

EX2012 - UT v. Liquidia, D. Del., ECF 16

EX2013 - UT v. Liquidia, D. Del., unnumbered docket entry dated 7/30/2020

EX2014 - UT v. Liquidia, D. Del., ECF 20 (excerpted)

EX2015 - UT v. Liquidia, D. Del., ECF 29

EX2016 - UT v. Liquidia, D. Del., ECF 45

EX2017 - UT v. Liquidia, D. Del., ECF 21

EX2018 - UT v. Liquidia, D. Del., ECF 41

EX2019 - UT v. Liquidia, D. Del., ECF 49

EX2020 - UT v. Liquidia, D. Del., ECF 68

EX2021 - UT v. Liquidia, D. Del., ECF 71

EX2022 - UT v. Liquidia, D. Del., ECF 40

EX2023 - UT v. Liquidia, D. Del., ECF 47

EX2024 - UT v. Liquidia, D. Del., ECF 75

EX2025 - UT v. Liquidia, D. Del., ECF 80

EX2026 - UT v. Liquidia, D. Del., ECF 81

EX2027 - UT v. Liquidia, D. Del., ECF 92

EX2028 - UT v. Liquidia, D. Del., ECF 74

EX2029 - Hess, 2007, A guide to aerosol delivery

EX2030 - Dennis, 2002, Standardization issues

EX2031 - Hess, 1996, Medication nebulizer

EX2032 - Rubin, 2008 Treatment Delivery Systems

EX2033 - Gardenhire, 2017, A Guide to Aerosol

EX2034 - Tyvaso�� Label 2021

EX2035 - Bourge, 2013, Cardiovascular Therapeutics

Patent Owner's Updated Mandatory Notices

ORDER Granting Petitioner's Unopposed Motion for Pro Hac Vice Admission of Deepa Kannappan

Petitioner's Unopposed Motion for Pro Hac Vice Admission of Deepa Kannappan

Petitioner's Updated Exhibit List

Declaration of Deepa Kannappan ISO Motion for Pro Hace Vice Admission

Biography of Deepa Kannappan

Petitioner's Updated Mandatory Notice Regarding Additional Backup Counsel

Petitioner's Updated Power of Attorney

ORDER Granting Patent Owner���s Request to Extend the Due Date for Preliminary Response 37 C.F.R. �� 42.5

Ex. 3001

Patent Owner's Updated Mandatory Notices

Notice of Accord Filing Date

Patent Owner Mandatory Notice

U.S. Patent No. 10,716,793 B2 to Olschewski, et al.

Curriculum Vitae of Dr. Igor Gonda

U.S. Patent No. 6,521,212 B1 to Cloutier, et al.

Voswinckel, R., et al., Abstract 218: ¿¿¿Inhaled treprostinil is a potent pulmonary vasodilator in severe pulmonary hypertension,¿¿¿ European Heart Journal 25:22 (2004)

Declaration of Dr. Nicholas Hill

Curriculum Vitae of Dr. Nicholas Hill

Declaration of Dr. Igor Gonda

Petitioner's Power of Attorney

Voswinckel, et al., Abst 1414: ¿¿¿Inhaled Treprostinil Sodium (TRE) For the Treatment of Pulmonary Hypertension,¿¿¿ Abst from the 2004 Scientific Sessions of the Amer Heart Assoc, Circ, 110(17 Suppl.):III-295 (October 26, 2004)

Ghofrani, 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.)

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

9,339,507 Patent Prosecution History (excerpted)

Stein, S.W., et al., ¿¿¿The History of Therapeutic Aerosols: A Chronological Review,¿¿¿ Journal of Aerosol Medicine and Pulmonary Drug Delivery, 30(1):20-41 (2017)

Hach¿¿, M., et al., ¿¿¿Inhaled epoprostenol (prostacyclin) and pulmonary hypertension before cardiac surgery,¿¿¿ Journal of Thoracic and Cardiovascular Surgery, 125:642-49 (2003)

U.S. Patent Application Publication No. US 2004/0265238 A1 to Chaudry

Petitioner's Petition for Inter Partes Review of US Patent No. 10,716,793

Voswinckel, et al., ¿¿¿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)

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.)

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.)

10,376,525 Patent Prosecution History (excerpted)

Remodulin¿¿ 2004 Label

Clark, A.R., ¿¿¿Medical Aerosol Inhalers: Past, Present, and Future,¿¿¿ Aerosol Science and Technology, 22:374-91 (1995)

Ruan, C.-H., et al., ¿¿¿Prostacyclin Therapy for Pulmonary Arterial Hypertension,¿¿¿ Texas Heart Institute Journal, 37(4):391-99 (2010)

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)

Olschewski, H., et al., ¿¿¿Inhaled Prostacyclin and Iloprost in Severe Pulmonary Hypertension Secondary to Lung Fibrosis,¿¿¿ American Journal of Respiratory Critical Care Medicine, 160:600-07 (1999)

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)

U.S. Patent No. 6,242,482 B1 to Shorr, et al.

De Wet, et al., ¿¿¿Inhaled prostacyclin is safe, effective, and affordable in patients with pulmonary hypertension, etc.,¿¿¿ J. of Thoracic and Cardiovascular Surgery, 127:1058-67 (2004)

Newman, S.P., ¿¿¿Aerosols¿¿¿, Chapter from Encyclopedia of Respiratory Medicine pp. 58-64 (2006)

Bender, B., et al., ¿¿¿Nonadherence in asthmatic patients: is there a solution to the problem?¿¿¿ Annals of Allergy, Asthma & Immunology, 79:177-86 (1997)

Rau, J.L., ¿¿¿Determinants of Patient Adherence to an Aerosol Regimen,¿¿¿ Respiratory Care 50(10):1346-56 (2005)

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/

Declaration of Sylvia Hall-Ellis, Ph.D.

Ventavis¿¿ Label 2004

Geller, D.E., ¿¿¿Comparing Clinical Features of the Nebulizer, Metered-Dose Inhaler, and Dry Powder Inhaler,¿¿¿ Respiratory Care, 50(10):1313-21 (2005)

Geller, D., et al., ¿¿¿Bolus Inhalation of rhDNase with the AERx System in Subjects with Cystic Fibrosis,¿¿¿ Journal of Aerosol Medicine, 16(2):175-82 (2003)

2009 Tyvaso¿¿ Label

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)

Vachi¿¿ry, J.-L., et al., ¿¿¿Transitioning From IV Epoprostenol to Subcutaneous Treprostinil in Pulmonary Arterial Hypertension,¿¿¿ CHEST, 121:1561-65 (2002)

Prober, C.G., et al., ¿¿¿Technical Report: Precautions Regarding the Use of Aerosolized Antibiotics,¿¿¿ Pediatrics, 106(6):1-6 (2000)

November 17, 2008 Press Release, ¿¿¿Eli Lilly and Company Licenses U.S. Rights for Tadalafil PAH Indication to United Therapeutics Corporation"

Hill, N.S., et al., ¿¿¿Inhaled Therapies for Pulmonary Hypertension,¿¿¿ Respiratory Care, 60(6):794-805 (2015)

English translation of OptiNeb¿¿ User Manual 2005

Atkins, P.J., ¿¿¿Dry Powder Inhalers: An Overview,¿¿¿ Respiratory Care, 50(10):1304-12 (2005)

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)

Chew N. and Chan H.-K., ¿¿¿Pharmaceutical Dry Powder Aerosol Delivery,¿¿¿ KONA, No. 19, pp. 46-56 (2001)

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)¿¿¿

9,358,240 Patent Prosecution History (excerpted)

U.S. Patent No. 9,358,240 to Olschewski, et al.

Hoeper, M.M., et al., ¿¿¿Long-Term Treatment of Primary Pulmonary Hypertension with Aerosolized Iloprost, a Prostacyclin Analogue,¿¿¿ N Engl J Med, 342:1866-70

Walmrath, D., et al., ¿¿¿Aerosolised prostacyclin in adult respiratory distress syndrome,¿¿¿ Lancet, 342:961-62 (1993)

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¿¿¿

Pulmozyme¿¿ Label

Farber, H.W. and Loscalzo, J., ¿¿¿Pulmonary Arterial Hypertension,¿¿¿ N Engl J Med, 351:1655-65 (2004)

Rubin, L.J. and Badesch, D.B., ¿¿¿Evaluation and Management of the Patient with Pulmonary Arterial Hypertension,¿¿¿ Ann Intern Med., 143:282-92 (2005)

Flolan¿¿ Label

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, I., ¿¿¿Study of the effects of polydispersity of aerosols on regional deposition in the respiratory tract,¿¿¿ J. Pharm. Pharmacol., 33 (Suppl.) 52P (1981)

Telko, M.J. and Hickey, A.J., ¿¿¿Dry Powder Inhaler Formulation,¿¿¿ Respiratory Care, 50(9):1209-27 (2005)

October 24, 2005 Press Release, ¿¿¿Aradigm Corporation And United Therapeutics Corporation Sign Development and Commercialization Agreement Targeting Pulmonary Hypertension"

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)

Nauser, T.D., ¿¿¿Pulmonary Hypertension: New Perspectives,¿¿¿ CHF, 9:155-62 (2003)

Dalby, R., et al., ¿¿¿A review of the development of Respimat¿¿ Soft MistTM Inhaler,¿¿¿ International Journal of Pharmaceutics, 283:1-9 (2004)

Gessler, T., et al., ¿¿¿Ultrasonic versus jet nebulization of iloprost in severe pulmonary hypertension,¿¿¿ Eur Respir J, 17:14-19 (2001)

Dolovich, M.B., et al., ¿¿¿Device Selection and Outcomes of Aerosol Therapy: Evidence-Based Guidelines,¿¿¿ CHEST, 127:335-71 (2005)

Olschewski, H., et al., ¿¿¿Inhaled Iloprost for Several Pulmonary Hypertension,¿¿¿ N Engl J Med, 347(5):322-29 (2002)

AccuNeb¿¿ Label

Anderson, P.J., ¿¿¿History of Aerosol Therapy: Liquid Nebulization to MDIs to DPIs,¿¿¿ Respiratory Care, 50(9):1139-49 (2005)

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

Beasley, R., et al., ¿¿¿Preservatives in Nebulizer Solutions: Risks without Benefit,¿¿¿ Pharmacotherapy, 18(1):130-39 (1998)

Aradigm Corporation Form 10-Q for the quarterly period ended June 30, 2009

Orenitram¿¿ Label

October 23, 2017 Press Release, ¿¿¿United Therapeutics Announces FDA Approval Of Third Generation Nebulizer For The Tyvaso¿¿ Inhalation System¿¿¿

Boyle, M.P., ¿¿¿So Many Drugs, So Little Time. The Future Challenge of Cystic Fibrosis Care,¿¿¿ CHEST, 123(1):3-5 (2003)

Azmacort¿¿ Label 2003