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Paper _____
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________
`
`STEADYMED LTD.
`Petitioner
`
`v.
`
`UNITED THERAPEUTICS CORPORATION
`Patent Owner
`
`
`U.S. Patent No. 8,497,393
`Issue Date: Jul. 30, 2013
`Title: PROCESS TO PREPARE TREPROSTINIL, THE ACTIVE
`INGREDIENT IN REMODULIN®
`_______________
`
`Case IPR2016-00006
`_______________
`
`
`Updated Patent Owner’s Exhibit List
`
`
`
`
`
`Mail Stop “PATENT BOARD”
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`4817-9668-7943.1
`
`

`

`IPR2016-00006
`U.S. Patent No. 8,497,393
`
`
`
`
`Exhibit List
`
`
`
`Ex #
`
`2001
`
`2002
`
`2003
`
`2004
`
`2005
`
`2006
`
`2007
`
`2008
`
`2009
`
`2010
`
`2011
`
`2012
`
`2013
`
`2014
`
`2015
`
`Exhibit Description
`
`November 19, 2015 Conference Call Before the Panel
`
`Remodulin® Label
`
`FDA Approval Letter
`
`Process Validation Report: (Protocol No.: “VAL 00131”)
`
`Process Optimization Report
`
`UTC Letter of January 2009 to FDA
`
`U.S. Patent No. 8,242,305; the ’305 patent;
`
`U.S. Provisional Patent Application No. 61/014,232
`
`U.S. Patent No. 8,748,657; the ’657 patent
`
`The ’657 patent prosecution history
`
`Zumdahl, Chemistry, pp. A25, A36 (1986)
`
`Brown, et al., Chemistry: The Central Science, pp. G-2, G-10 (9th ed.
`
`2003)
`
`Trial testimony of Dr. Williams and Dr. Aristoff
`
`Suchocki, et al., Conceptual Chemistry, p. G-6 (2001)
`
`U.S. Patent No. 4,668,814; the ’814 patent
`
`4817-9668-7943.1
`
`2
`
`

`

`IPR2016-00006
`U.S. Patent No. 8,497,393
`
`
`
`
`Exhibit List
`
`2016
`
`2017
`
`2018
`
`2019
`
`2020
`
`2021
`
`2022
`
`2023
`
`2024
`
`2025
`
`2026
`
`UTC Form 10K 2014 Annual Report
`
`Declaration of Liang Gou, Ph.D., dated May 9, 2016 (not filed)
`
`Declaration of Rex Mauthe, dated May 10, 2016 (not filed)
`
`May 10, 2016 Conference Call Before the Panel
`
`Declaration of Robert M. Williams, Ph.D
`
`Curriculum Vitae of Robert M. Williams, Ph.D
`
`Declaration of Robert R. Ruffolo, Jr., Ph.D
`
`Curriculum Vitae of Robert R. Ruffolo, Jr., Ph.D
`
`The Scotts Co., LLC v. Encap, LLC, IPR2013-00110, Paper 79 (PTAB
`
`June 24, 2014)
`
`Prosecution History of U.S. Patent No. 6,209,259
`
`Williams, et.al., Asymmetric, Stereocontrolled Total Synthesis of
`
`Paraherquamide A, J. Am. Chem. Soc. 2003, 125, 12172-12178.
`
`2027
`
`Williams, et.al., Stereocontrolled Total Synthesis of (+)-
`
`Paraherquamide B, J. Am. Chem. Soc. 1996, 118, 557-579.
`
`2028
`
`Williams, et.al., Synthetic Studies on Et-743. Assembly of the
`
`Pentacyclic Core and a Formal Total Synthesis, J. Org. Chem. 2008,
`
`73, 9594-9600.
`
`4817-9668-7943.1
`
`3
`
`

`

`IPR2016-00006
`U.S. Patent No. 8,497,393
`
`
`
`
`Exhibit List
`
`2029
`
`Winkler, J., et.al., A Pauson-Khand Approach to the Synthesis of
`
`Ingenol, Org. Lett., 2005, 8, 1489-1491.
`
`2030
`
`R. Adhiyaman, et.al., Crystal modification of dipyridamole using
`
`different solvents and crystallization conditions, Int’l J. Pharm. 2006,
`
`321, 27-34.
`
`2031
`
`Marti, E., Purity determination by differential scanning calorimetry,
`
`2032
`
`2033
`
`2034
`
`2035
`
`2036
`
`Thermochimica Acta, 1972, 5, 173-220.
`
`U.S. Patent No. 4,306,075
`
`U.S. Patent Nos. 5,153,222
`
`ICH Guidance For Industry: Q7A Good Manufacturing Practice
`
`Guidance for Active Pharmaceutical Ingredients (2001).
`
`Reviewer Guidance: Validation of Chromatographic Methods (1994).
`
`Certificate of Analysis data for 56 samples of treprostinil product as
`
`produced by the prior art process according to Moriarty through 2004
`
`2037
`
`Certificate of Analysis data for 157 samples of treprostinil product as
`
`produced by the ’393 patent processes
`
`2038
`
`ICH Harmonised Tripartite Guideline: Impurities in New Drug
`
`Substances Q3A(R2) (2006)
`
`4817-9668-7943.1
`
`4
`
`

`

`IPR2016-00006
`U.S. Patent No. 8,497,393
`
`
`
`
`Exhibit List
`
`2039
`
`ICH Guidance for Industry: M7 Assessment and Control of DNA
`
`Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential
`
`Carcinogenic Risk (2015)
`
`2040
`
`Olsen, Bernard A., What’s New with Impurities in Pharmaceuticals?,
`
`Southern California Pharmaceutical Discussion Group, January 15,
`
`2015
`
`2041
`
`“Janet Woodcock,” available at
`
`http://www.fiercebiotech.com/special-report/janet-woodcock-fda
`
`(accessed July 6, 2016)
`
`2042
`
`Carpenter, The Political Economy of FDA Drug Review: Processing,
`
`Politics and Lessons for Policy (2004)
`
`2043
`
`ICH Draft Consensus Guideline: Guideline for Elemental Impurities
`
`Q3D (2013)
`
`2044
`
`ICH Guidance For Industry: Q7A Good Manufacturing Practice
`
`Guidance for Active Pharmaceutical Ingredients (2001)
`
`2045
`
`Schrager et al., Diethylstilbestrol Exposure, American Family
`
`Physician, 2004, 10, 2395-2400.
`
`2046
`
`NTP Report on Carcinogens Background Document for Saccharin
`
`4817-9668-7943.1
`
`5
`
`

`

`IPR2016-00006
`U.S. Patent No. 8,497,393
`
`
`(1999)
`
`
`
`Exhibit List
`
`2047
`
`FDA Guidance for Industry: Non-Penicillin Beta-Lactam Drugs: A
`
`CGMP Framework for Preventing Cross-Contamination (2013)
`
`2048
`
`Heinemann and Richter, Clinical Pharmacology of Human Insulin,
`
`Diabetes Care, 1993, 3, 90-100.
`
`2049
`
`“FDA: Drug Shortages,” available at
`
`http://www.fda.gov/Drugs/DrugSafety/DrugShortages/ (accessed July
`
`5, 2016)
`
`2050
`
`FDA Guidance for Industry: Changes to an Approved NDA or ANDA,
`
`(2004)
`
`2051
`
`2052
`
`Transcript of June 14, 2016 Deposition of Dr. Jeffrey D. Winkler
`
`UT-15 Injection Drug Substance Volume 1.2 Chemistry,
`
`Manufacturing and Controls, NDA 21-272
`
`2053
`
`United Therapeutics NDA Annual Report, Remodulin® (treprostinil
`
`sodium) Injection
`
`2054
`
`United Therapeutics Silver Spring Process Optimization Report for the
`
`Conversion of UT-15C Intermediate to UT-15 API (Treprostinil)
`
`2055
`
`Declaration of Robert A. Delafield II, dated July 25, 2016 (not filed)
`
`4817-9668-7943.1
`
`6
`
`

`

`IPR2016-00006
`U.S. Patent No. 8,497,393
`
`
`
`
`Exhibit List
`
`Declaration of Thomas Higgs, dated July 27, 2016 (not filed)
`
`Declaration of Rex Mauthe, dated July 27, 2016 (not filed)
`
`Deposition transcript of Dr. Robert R. Ruffolo, Jr., Ph.D
`
`Deposition transcript of Dr. Robert M. Williams, Ph.D
`
`October 6, 2016 Conference Call Before the Panel
`
`Patent Owner’s Hearing Demonstratives
`
`April 5, 2017 Conference Call Before the Panel
`
`January 3, 2018 Conference Call Before the Panel
`
`2056
`
`2057
`
`2058
`
`2059
`
`2060
`
`2061
`
`2062
`
`2063
`
`
`
`Date: January 8, 2018
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`
`
`Respectfully submitted,
`
`
`
`/Stephen B. Maebius/
`Stephen B. Maebius
`Registration No. 35,264
`Counsel for Patent Owner
`
`
`4817-9668-7943.1
`
`7
`
`

`

`IPR2016-00006
`Patent 8,497,393
`
`
`
`
`CERTIFICATE OF SERVICE
`
`The undersigned hereby certifies that a copy of the Updated Exhibit List and
`
`Exhibit 2062 were served on January 8, 2018 via email to the counsel of record for
`
`the Petitioner at the following address: Steadymed-IPR@dlapiper.com.
`
`
`
`
`
`Date: January 8, 2018
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`/Stephen B. Maebius/
`Stephen B. Maebius
`Registration No. 35,264
`Counsel for Patent Owner
`
`
`
`
`
`
`4817-9668-7943.1
`
`

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