`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_____________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________________
`
`
`CATALENT PHARMA SOLUTIONS, INC.,
`Petitioner
`
`v.
`
`PATHEON SOFTGELS INC.,
`Patent Owner
`
`_____________________
`
`Case IPR2018-00422
`U.S. Pat. No. 9,693,979
`_____________________
`
`
`
`PATHEON SOFTGELS INC.’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
`
`
`
`
`
`
`
`
`IPR2018-00422
`Patent 9,693,979 B2
`
`
`
`Patheon
`Exhibit #
`2001
`2002
`2003
`
`2004
`
`2006
`
`Description
`
`Declaration of Mansoor Khan, R.Ph., Ph.D.
`Curriculum Vitae for Mansoor Khan, R.Ph., Ph.D.
`Serajuddin, A., “Solid Dispersion of Poorly Water-Soluble Drugs:
`Early Promises, Subsequent Problems, and Recent Breakthroughs,” J.
`Pharm. Sci., 88:1058–1066 (1999)
`Patravale, V.B. et al., “Nanosuspensions: a promising drug delivery
`strategy,” J. Pharm. & Pharmacol., 56:827–840 (2004)
`2005 WO 95/31979 to Shelley et al., “Solutions of Aryl or Heteroaryl
`Susbtituted Alkanoic Acids in Lipophilic Solvents and Soft Gelatin
`Capsules Containing Such Solutions” (Nov. 30, 1995)
`Ranucci et al., “Pharmacokinetic results on naproxen prodrugs based
`on poly(ethyleneglycol)s,” J. Biomater. Sci. Polymer Edn., 6:141–147
`(1994)
`2007 WO 95/31194 to Shapiro, H., “Compositions for Treatment of Chronic
`Inflammatory Diseases” (Nov. 23, 1995)
`Shah et al., “In Vitro Dissolution Profile of Water-Insoluble Drug
`Dosage Forms in the Presence of Surfactants,” Pharm Res. 6:612-618
`(1989)
`Crowley and Martini, “Physicochemical Approaches to Enhancing
`Oral Absorption,” Pharm. Tech. Eur., 16:18-27 (2004)
`Serajuddin et al., “Water Migration from Soft Gelatin Capsule Shell to
`Fill Material and Its Effect on Drug Solubility,” J. Pharm. Sci.,
`75:62-64 (1986)
`2011 Merisko-Liversidge et al., “Nanosizing: a formulation approach for
`poorly-water-soluble compounds,” Eur. J. Pharm. Sci., 18:113-120
`(2003)
`Naprosyn®, Physician’s Desk Reference, 48th ed., 2363–2365 (1994)
`Anaprox®, Physician’s Desk Reference, 48th ed., 2350–2352 (1994)
`Aleve®, Physician’s Desk Reference, 49th ed., 1910 (1995)
`Naprelan®, Physician’s Desk Reference, 53rd ed., 3335–3337 (1999)
`
`2008
`
`2009
`
`2010
`
`2012
`2013
`2014
`2015
`
`
`
`- 1 -
`
`
`
`IPR2018-00422
`Patent 9,693,979 B2
`
`
`
`Patheon
`Exhibit #
`2016
`
`2017
`
`2018
`
`2019
`
`2020
`
`2021
`
`2022
`
`2023
`
`2024
`
`2025
`
`2026
`
`Description
`
`FDA Approved Products: Naprosyn®, available at
`https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=ove
`rview.process&ApplNo=017581, last accessed May 19, 2018
`FDA Approved Products: Anaprox®, available at
`https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=ove
`rview.process&ApplNo=018164, last accessed May 19, 2018
`FDA Approved Products: Naprelan®, available at
`https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=ove
`rview.process&ApplNo=020353, last accessed May 19, 2018
`FDA Approved Products: Aleve®, available at
`https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=ove
`rview.process&ApplNo=020204, last accessed May 19, 2018
`FDA Approved Products: Naproxen Sodium Soft Gelatin Capsules,
`available at
`https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=ove
`rview.process&ApplNo=021920, last accessed May 19, 2018
`Tabibi and Gupta, “Soft Gelatin Capsules Development,” in Water
`Insoluble Drug Formulation, Chapter 17, pp. 609–633, Interpharm
`Press (2000)
`Seager and Slabaugh, “Acids, Bases, and Salts,” in Introductory
`Chemistry, Chapter 9, Scott, Forsman and Co. (1979)
`Gennadios, “Soft Gelatin Capsules,” in Protein-Based Films and
`Coatings, Chapter 16, pp. 393 – 443, CRC Press LTD (2002)
`Recorded Assignments for U.S. Patent Nos. 9,693,978 and 9,693,979,
`Reel 043042, Frame 0619 to 0652 (recorded June 29, 2017)
`International Conference on Harmonisation, “Topic Q3B: ICH
`Harmonised Tripartite Guideline for Impurities in New Medicinal
`Products,” (November 6, 1996)
`The Merck Index, Merck & Co., Inc., 12th Ed. (1996), pp. xii-xvii,
`392-393, 641-642, 763-764, 911, 1101, 1305, 1320, and 1349
`
`
`
`- 2 -
`
`
`
`IPR2018-00422
`Patent 9,693,979 B2
`
`
`Patheon
`Exhibit #
`2027
`
`
`
`
`Description
`
`
`
`Chang, R., “Chemistry,” 6th ed., Ch. 15, pp. 597–641, McGraw-Hill
`(1998)
`
`Respectfully submitted,
`
`
`
`STERNE, KESSLER, GOLDSTEIN & FOX P.L.L.C.
`
`Date: May 22, 2018
`
`
`
`
`
`
`/Eldora L. Ellison/
`Eldora L. Ellison, Ph.D.
`Lead Counsel for Patent Owner
`1100 New York Avenue, N.W. Registration No. 39,967
`Washington, D.C.20005-3934
`
`(202) 371-2600
`
`9372675_1.DOC
`
`
`
`
`
`
`- 3 -
`
`
`
`CERTIFICATE OF SERVICE (37 C.F.R. § 42.6(e))
`
`
`
`The undersigned hereby certifies that the above-captioned Patheon Softgels
`
`Inc.'s Exhibit List, along with Exhibits 2001-2027, were served in their entirety on
`
`May 22, 2018, upon the following parties via email:
`
`Gregory L. Porter:
`Rose Cordero Prey:
`David Bradin:
`
`
`GregPorter@andrewskurth.com
`rprey@andrewskurthkenyon.com
`DavidBradin@andrewskurth.com
`
`
`
`
`
`
`
` STERNE, KESSLER, GOLDSTEIN & FOX P.L.L.C.
`
`
`
`
`
`
`/Eldora L. Ellison/
`Eldora L. Ellison, Ph.D.
`Lead Counsel for Patent Owner
`1100 New York Avenue, N.W. Registration No. 39,967
`Washington, D.C. 20005-3934
`
`(202) 371-2600
`
`
`
`
`
`Date: May 22, 2018
`
`
`
`
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