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`UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________
`
`
`WATSON LABORATORIES, INC.
`Petitioner
`
`v.
`
`UNITED THERAPEUTICS, INC.
`Patent Owner
`
`
`
`Patent No. 9,358,240
`Issue Date: June 7, 2016
`Patent No. 9,339,507
`Issue Date: May 17, 2016
`
`Title: TREPROSTINIL ADMINISTRATION BY INHALATION
`_______________
`
`Inter Partes Review No. 2017-01621
`Inter Partes Review No. 2017-01622
`____________________________________________________________
`
`PATENT OWNER UPDATED EXHIBIT LIST1
`AS OF MAY 15, 2018
`
`
`
`
`1 Word-for-word identical document is being filed in IPR2017-01621 and
`IPR2017-1622.
`4817-5803-6582.1
`
`

`

`IPR2017-01621
`IPR2017-01622
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`Exhibit No.
`2001
`2002
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`2003
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`2004
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`2005
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`2006
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`2007
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`2008
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`2009
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`2010
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`2011
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`2012
`2013
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`2014
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`2015
`2016
`2017
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`2018
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`4817-5803-6582.1
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`Updated Exhibit List
`
`Description
`Declaration of Dr. Richard Dalby
`Oxford Dictionary of English, 2nd ed. Revised. Oxford University
`Press, 2005 (excerpt).
`Newman, Stephen P., Respiratory drug delivery: essential theory and
`practice. Respiratory Drug Delivery Online, 2009 (excerpt).
`Hill, N., Therapeutic Options for the Treatment of Pulmonary
`Hypertension, Medscape Pulmonary Medicine 9(2) (2005).
`Exhibits Accompanying First Declaration of Dr. Roham Zamanian
`and Amendment and Reply filed in 12/591,200 (Nov. 9, 2015) (Ex.
`1162)
`Declaration of Dr. Edmund Elder and Exhibits Accompanying
`Second Declaration of Dr. Roham Zamanian, Amendment and Reply
`filed in 12/591,200 (Feb. 2, 2016) (Ex. 1163)
`Finlay, Warren H., The Mechanics of Inhaled Pharmaceutical
`Aerosols: an Introduction. Academic Press, 2002 (excerpt).
`“Mechanical Ventilation,” American Journal of Respiratory and
`Critical Care Medicine 196(2):P3-4 (2017).
`Motion for Leave to File An Amended Complaint and Exhibits Filed
`in Civil Action No: 3:15-cv-05723 PGS-LHG
`Email Correspondence to Watson’s Counsel Serving Motion for
`Leave to File An Amended Complaint and attached Exhibits (Ex.
`2009).
`Consent Order Entering Motion for Leave to File An Amended
`Complaint in Civil Action No: 3:15-cv-05723 PGS-LHG
`Orange Book Listing for Tyvaso® (Accessed October 3, 2017)
`First Notice Letter Sent June 12, 2015 by Watson Regarding Orange
`Book Listed Tyvaso® Patents
`Issue Notifications for US Patent No. 9,399,507 and US Patent No.
`9,358,240
`FDA Form 3542, Listing US Patent No. 9,399,507 in Orange Book
`FDA Form 3542, Listing US Patent No. 9,358,240 in Orange Book
`Email Correspondence between United Therapeutics and Watson
`Regarding Proposed Schedule for Civil Action No: 3:15-cv-05723
`PGS-LHG in view of US Patent No. 9,399,507 and US Patent No.
`9,358,240
`Second Notice Letter Sent June 29, 2016 by Watson Regarding
`Orange Book Listed Tyvaso® Patents
`2
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`

`IPR2017-01621
`IPR2017-01622
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`2019
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`2020
`2021
`2022
`2023
`2024
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`2025
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`2026
`2027
`2028
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`2044
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`Updated Exhibit List
`
`Docket Navigator Summary Statistics on Unopposed Motions for
`Magistrate Judge Lois H. Goodman
`Declaration of Dr. Werner Seeger
`Bourge et al., Cardiovascular Therapeutics 31:38-44 (2013)
`Curriculum vitae of Dr. Richard Dalby
`Curriculum vitae of Dr. Lewis Rubin
`2002 Press Release Regarding Promotion of Robert Roscingo
`(accessed October 10, 2017)
`Shield Therapeutics Biography for Carl Sterritt (accessed October
`10, 2017)
`Declaration of Dr. Hossein A. Ghofrani
`Declaration of Dr. Frank Reichenberger
`Declaration of Dr. Freidrich Grimminger
`Excerpts from Deposition of Dr. Maureen Donovan in Civil Action
`No: 3:15-cv-05723 PGS-LHG
`Email Correspondence with Orange Book Staff Confirming Date of
`Listing for US Patent No. 9,399,507 and US Patent No. 9,358,240
`Email Correspondence with USTPO regarding Petitioner’s Request
`to File a Reply
`Feb. 23, 2018 Conference Call Transcript
`Transcript from March 28, 2018 Deposition of Dr. Scott Bennett
`Transcript from April 4, 2018 Deposition of Dr. Maureen Donovan
`Transcript from April 6, 2018 Deposition of Dr. DeForest McDuff
`Email Correspondence with Petitioner regarding Deposition of
`Christopher Butler
`Listing of Issues and Supplements of Circulation Accessible on
`Circulation Website (accessed April 17, 2018)
`Second Declaration of Dr. Richard Dalby
`US 4,319,155 (“Nakai”)
`Declaration of Dr. Aaron Waxman
`Curriculum vitae of Dr. Aaron Waxman
`Mosby’s Medical Dictionary, 7th ed. Mosby Elsevier, 2006 (excerpt).
`Leung, K, Louca E., & Coates, A., “Comparison of Breath-Enhanced
`to Breath-Actuated Nebulizers for Rate, Consistency, and
`Efficiency,” Chest, 126(5):1619-1627 (2004)
`Rau, J.L., “Design Principles of Liquid Nebulization Devices
`Currently in Use,” Respir. Care, 47(11):1257-1275 (2002)
`
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`2066
`2067
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`Updated Exhibit List
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`Atkins, P.J. & T.M. Crowder, “The Design and Development of
`Inhalation Drug Delivery Systems,” Pharmaceutical Inhalation
`Aerosol Technology, 2nd Ed. (A.J. Hichey ed., CRC Press), Ch. 9
`(2003)
`Ventavis® Patient Brochure
`Rau, J.L., Respiratory Care Pharmacology. 6th Ed. Mosby, 2002
`(excerpt)
`Declaration of Dr. Robert Roscigno
`Excerpts from Tyvaso® NDA Integrated Summary of Efficacy (ISE)
`Clinical Investigation Report Synopsis for LungRx Study No: LRX-
`TRE-INH-0004
`Clinical Investigation Report Synopsis for LungRx Study No: LRX-
`TRE-INH-0007
`Letter from FDA confirming IND filing
`Declaration of Dr. Jeffrey Stec
`Curriculum vitae and Record of Prior Testimony of Dr. Jeffrey Stec
`Tyvaso® (treprostinil) An Inhaled Prostacyclin Analogue, Internal
`Presentation
`Classes of Heart Failure, American Heart Association (accessed
`April 19, 2017)
`FDA Approves TYVASO (Treprostinil) Inhalation Solution for the
`Treatment of Pulmonary Arterial Hypertension, July 30, 2009
`2014 Fourth-Quarter and Annual Financial Results, Investor
`Conference Call Q&A
`Voswinckel, R., et al., “Favorable Effects of Inhaled Treprostinil in
`Severe Pulmonary Hypertension: Results from Randomized
`Controlled Pilot Studies,” JACC, 48(6): 1672-1681(2006)
`Tyvaso®: Just Prescribed (accessed April 5, 2018)
`The World’s Biggest Public Companies – United Therapeutics,
`Forbes (accessed April 26, 2018)
`America’s Best Small Public Companies, Forbes (accessed April 26,
`2018)
`Fastest-Growing Companies, Fortune (accessed April 26, 2018)
`United Therapeutics Corp., Morningstar (accessed March 29, 2017)
`Tyvaso 2014 Brand Plan, Internal
`2013 Marketing Plan, Internal
`Tyvaso Marketing Overview, August 19, 2015, Internal
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`IPR2017-01622
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`Updated Exhibit List
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`Pulmonary Arterial Hypertension (PAH) Therapeutics – Global Drug
`Forecasts and Treatment Analysis to 2020, Internal
`Frumkin L.R., “The Pharmacological Treatment of Pulmonary
`Arterial Hypertension” Pharmacol. Rev. 64:583-620 (2012)
`Khaybullina D., et al., “Riociguat (Adempas): a Novel Agent For the
`Treatment of Pulmonary Arterial Hypertension and Chronic
`Thromboembolic Pulmonary Hypertension,” Pharmacy and
`Therapeutics. 39(11):749-758.
`Project Clock Discussion Materials, February 3, 2016, Internal
`Actelion Delivers Outstanding 2014 Results, Actelion website
`(accessed April 26, 2018)
`Bloomberg L.P. WACC Report for UTHR (accessed March 14,
`2017)
`Pulmonary Arterial Hypertension Market Surveillance ATU: Wave 5
`(Q2 ’15) – Final Report, Fielded July 2015, Internal
`2014 Fourth-Quarter and Annual Financial Results, Investor
`Conference Call Q&A, Internal
`RESERVED
`Gagnon, M-A & Lexchin, J., “The Cost of Pushing Pills: A New
`Estimate of Pharmaceutical Promotion Expenditures in the United
`States,” PLoS Medicine. 5(1):epub (2008).
`McDuff, R.D., et al., “Thinking Economically about Commercial
`Success,” Landslide Magazine 9(4) (2017)
`David, J. & Stewart M.B., “Commercial Success: Economic
`Principles Applied to Patent Litigation.” Leonard G.K. & Stiroh
`L.J.(Ed.), Economic Approaches to Intellectual Property: Policy,
`Litigation, and Management, New York: National Economic
`Research Associates Inc. 196-207 (2005)
`Grabowski, H. & Vernon, J., “The Distribution of Sales Revenue
`from Pharmaceutical Innovation,” Pharmacoeconomics, 18 Suppl.1
`(2000)
`US 8,410,121 (“the ’121 patent”)
`US 9,550, 716 (“the ’716 patent”)
`TRIUMPH I Phase II Clinical Trial Protocol, created by January 11,
`2005
`ClinicalTrials.gov entry for TRIUMPH trial, NCT00147199
`(accessed April 20, 2018)
`Declaration of Dean Bunce
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`Updated Exhibit List
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`IPR2017-01621
`IPR2017-01622
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`2086
`2087
`2088
`2089
`2090
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`February 17, 2010 Withdrawal Letter
`United Therapeutics Corporation 2017 10-K
`2012 Tyvaso Brand Plan, Internal
`Tyvaso Marketing Plan, December 2010, Internal
`GlobalData Advanced Export - Pulmonary Arterial Hypertension,
`April 2017
`St. Louis Federal Reserve, Consumer Price Index,
`https://fred.stlouisfed.org/series/CPIAUCSL (accessed April 5, 2017)
`Email from British Library regarding Voswinckel
`Declaration of Ms. Pilar Wyman
`Curriculum vitae of Pilar Wyman
`McLaughlin, V.V., et al., “Addition of Inhaled Treprostinil to Oral
`Therapy for Pulmonary Arterial Hypertension: A Randomized
`Controlled Clinical Trial,” JACC, 18:1915-1922 (2010) (with
`appendix)
`Author & Subject Index for Circulation Supplement 17 (2004)
`Declaration of Dr. Werner Seeger Accompanying Amendment and
`Reply filed in 13/469,854 dated August 20, 2015
`Second Declaration of Dr. Werner Seeger
`Second Declaration of Dr. Hossein A. Ghofrani
`U.S. Application No. 60/800,016
`Services Agreement between Dr. Werner Seeger and LungRx dated
`Sept.23, 2003
`LungRx TRIUMPH Executive Committee Meeting Agenda dated
`October 22, 2003
`German language version of Ex. 1005 (also provided as Attachment
`2d to Ex. 1013)
`Bloomberg L.P. WACC Report for UTHR, 2003
`2104
`2105-2200 RESERVED
`2201
`Claims of Abandoned U.S. Application No. 11/748,205
`Inventor Oaths filed in U.S. Application No. 12/591,200 (granted as
`the ’240 patent) and U.S. Application No. 13/469,854 (granted as the
`’507 patent)
`Dismissal of Complaint of Dr. Lewis Rubin and Motion for
`Attorney’s Fees
`Excerpts from Deposition of Dr. Lewis Rubin
`Transcript of teleconference between the parties and the Board, May
`10, 2018
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`2091
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`2205
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`

`IPR2017-01621
`IPR2017-01622
`
`
`
`
`
`Date: May 15, 2018
`
`
`
`
`
`
`
`Updated Exhibit List
`
`Respectfully submitted,
`
`/George E. Quillin/
`
`Stephen B. Maebius
`Registration No. 35,264
`
`George E. Quillin
`Registration No. 32,792
`
`Foley & Lardner LLP
`3000 K Street, N.W.
`Suite 600
`Washington, D.C. 20007
`
`Shaun R. Snader
`Registration No. 59,987
`United Therapeutics Corporation
`1735 Connecticut Avenue, N.W.
`Second Floor
`Washington, DC 20009
`
`Counsel for Patent Owner
`
`
`4817-5803-6582.1
`
`7
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`
`
`CERTIFICATE OF SERVICE
`The undersigned certifies that a copy of the foregoing PATENT OWNER
`UPDATED EXHIBIT LIST is being served on May 15, 2018, by filing this
`document through the PTAB E2E System as well as delivering copies via email to
`the following counsel for the Petitioner:
`
`Michael K. Nutter (Reg. No. 44,979)
`WINSTON & STRAWN LLP
`35 W. Wacker Dr.
`Chicago, IL 60601
`Email: mnutter@winston.com
`
`
`
`Andrew R. Sommer (Reg. No. 53,932)
`WINSTON & STRAWN LLP
`1700 K Street, N.W.
`Washington, DC 20006-3817
`Email: asommer@winston.com
`
`
`
`Kurt A. Mathas
`WINSTON & STRAWN LLP
`35 W. Wacker Dr.
`Chicago, IL 60601
`Email: kmathas@winston.com
`
`4817-5803-6582.1
`
`/George E. Quillin/
`
`Stephen B. Maebius
`Registration No. 35,264
`
`George E. Quillin
`Registration No. 32,792
`
`Shaun R. Snader
`Registration No. 59,987
`
`Counsel for Patent Owner
`
`