`
`
`
`
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_______________
`
`
`AMNEAL PHARMACEUTICALS LLC, and AMNEAL
`PHARMACEUTICALS OF NEW YORK, LLC, and
`MYLAN PHARMACEUTICALS INC.,
`Petitioners
`
`v.
`
`ALMIRALL, LLC,
`Patent Owner
`
`
`Case IPR2019-002071
`Patent 9,517,219
`
`
`
`PATENT OWNER’S UPDATED EXHIBIT LIST
`
`
`
`
`
`
`
`
`1 Cases IPR2019-00207 and IPR2019-01095 have been joined in this proceeding.
`
`
`
`IPR2019-00207
`Patent Owner’s Updated Exhibit List
`
`
`Exhibit No.
`2001
`
`2002
`
`2003
`
`2004
`
`2005
`
`2006
`
`2007
`
`2008
`
`2009
`
`2010
`
`2011
`
`2012
`
`2013
`
`Description
`International Patent Application Publication No. WO 2009/108147
`(“Garrett II”)
`International Patent Application Publication No. WO 2010/105052
`(“Hani”)
`Redline Comparison of Petitions in IPR2018-00608 and
`IPR2019-00207
`Redline Comparison of Michniak-Kohn Declarations in
`IPR2018-00608 and IPR2019-00207
`Redline Comparison of Gilmore Declarations in IPR2018-00608
`and IPR2019-00207
`Petitioner’s Notice of Paragraph IV Certification to Patent Owner
`(February 22, 2019) (truncated)
`Declaration of Elizabeth B. Hagan in Support of Patent Owner
`Almirall, LLC’s Motion for Admission Pro Hac Vice
`International Patent Application Publication No. WO 2011/014627
`(“Ahluwalia”)
`Dina Anderson, Finding a Place for Topical Anti-inflammatory
`Acne Therapy, Practical Dermatology 17 (July 2009)
`(“Anderson”)
`Christin N. Collier et al., The prevalence of acne in adults 20 years
`and older, 58 J. Am. Acad. Dermtol. 56 (2008) (“Collier”)
`Loren Cordain et al., Acne Vulgaris: A Disease of Western
`Civilization, 138 Arch Dermatol. 2584 (2002) (“Cordain”)
`Barry Coutinho, Dapsone (Aczone) 5% Gel for the Treatment of
`Acne, Am. Family Physician (2010) (“Coutinho”)
`James Q. Del Rosso, Newer Topical Therapies for the Treatment
`of Acne Vulgaris, 80 Cutis 400 (2007) (“Del Rosso 2007”)
`
`2
`
`
`
`IPR2019-00207
`Patent Owner’s Updated Exhibit List
`
`
`Exhibit No.
`2014
`
`2015
`
`2016
`
`2017
`
`2018
`
`2019
`
`2020
`
`2021
`
`2022
`
`2023
`
`Description
`Gabriella Fabbrocini et al., Resveratrol-Containing Gel for the
`Treatment of Acne Vulgaris: A Single-Blind, Vehicle-Controlled,
`Pilot Study, 12 Am. J. Clin. Dermatol. 133 (2011) (“Fabbrocini”)
`Zoe D. Draelos et al., Two randomized studies demonstrate the
`efficacy and safety of dapsone gel, 5% for the treatment of acne
`vulgaris, 46 J. Am. Acad. Dermatol. 439.e1 (2007) (“Draelos”)
`A. B. Fleischer et al., Dapsone Gel 5% in Combination with
`Adapalene Gel 0.1%, Benozoyl Peroxide Gel 4% or Moisturizer
`for the Treatment of Acne Vulgaris: A 12-Week, Randomized,
`Double-Blind Study, 9 J. Drugs Dermatol. 33 (2010) (“Fleischer”)
`Michael Ghods et al., The Role of Dapsone Gel in the Acne
`Armamentarium, The Dermatologist (June 10, 2010) (“Ghods”)
`William D. James, Acne, 352 New Eng. J. Medicine 463 (2005)
`(“James 2005”)
`Kirk A. James et al., Emerging Drugs for Acne, 14 Expert
`Opinions on Emerging Drugs 649 (2009) (“James 2009”)
`Leon H. Kircik, Harnessing the Anti-inflammatory Effects of
`Topical Dapsone for Management of Acne, 9 J. Drugs Dermatol.
`667 (2010) (“Kircik 2010”)
`Leon Kircik and Adam Friedman, Optimizing Acne Therapy With
`Unique Vehicles, 9 J. Drugs Dermatol. S53 (2010)
`(“Kircik 2010a”)
`Leon H. Kircik, Synergy and Its Clinical Relevance in Topical
`Acne Therapy, 4 J. Clin. Aethet. Dermatol. 30 (2011)
`(“Kircik 2011”)
`Leon H. Kircik, Microsphere Technology: Hype or Help?,
`4 J. Clin. Aesthet. Dermatol. 27 (2011) (“Kircik 2011a”)
`
`3
`
`
`
`IPR2019-00207
`Patent Owner’s Updated Exhibit List
`
`
`Exhibit No.
`2024
`
`2025
`
`2026
`
`2027
`
`2028
`
`2029
`
`2030
`
`2031
`
`2032
`
`2033
`
`Description
`H.C. Korting & C. Schöllmann, Current topical and systemic
`approaches to treatment of rosacea, 23 J. Eur. Acad. of
`Dermatology and Venereology 876, 876 (2009) (“Korting”)
`John Kraft & Anatoli Freiman, Management of acne, 183
`Canadian Med. Assoc. J. E430 (2011) (“Kraft”)
`Evgenia Makrantonaki et al., An update on the role of the
`sebaceous gland in the pathogenesis of acne, 3 Dermato-
`Endocrinology 41 (2011) (“Makrantonaki”)
`Otto H. Mills et al., Comparing 2.5%, 5%, and 10% Benzoyl
`Peroxide on Inflammatory Acne Vulgaris, 25 Int’l J. Dermatology
`664 (1986) (“Mills”)
`Warren W. Piette et al., Hematologic Safety of Dapsone Gel, 5%,
`for Topical Treatment of Acne Vulgaris, 144 Arch. Dermatol. 1564
`(2008) (“Piette”)
`Frank C. Powell, Rosacea, 352 New Eng. J. Med. 793 (2005)
`(“Powell”)
`Thierry Simonart, Newer Approaches to the Treatment of Acne
`Vulgaris, 13 Am. J. Clin. Dermatol. 357 (2012) (“Simonart”).
`MaryAnn Steiner, Dapsone Topical Gel for Acne, 12 J Pharm Soc.
`Wisc. 67 (2009) (“Steiner”)
`John S. Strauss, Biology of the Sebaceous Gland and the
`Pathophysiology of Acne Vulgaris, Chapter 13 in Pathophysiology
`of Dermatologic Diseases, Second Edition, N. A. Soter and H.
`Baden eds., McGraw-Hill, New York (1991) (“Strauss 1991”)
`John S. Strauss et al., Guidelines of care for acne vulgaris
`management, 56 J. Am. Acad. Dermatol. 651 (2007)
`(“Strauss 2007”)
`
`4
`
`
`
`IPR2019-00207
`Patent Owner’s Updated Exhibit List
`
`
`Exhibit No.
`2034
`
`2035
`
`2036
`
`2037
`
`2038
`
`2039
`2040
`2041
`
`2042
`2043
`
`2044
`
`Description
`Emil Tanghetti et al., Clinical Evidence for the Role of a Topical
`Anti-Inflammatory Agent in Comedonal Acne: Findings From a
`Randomized Study of Dapsone Gel 5% in Combination With
`Tazarotene Cream 0.1% in Patients With Acne Vulgaris,
`10 J. Drugs Dermatol. 783 (2011) (“Tanghetti”)
`Diane Thiboutot et al., An aqueous gel fixed combination of
`clindamycin phosphate 1.2% and benzoyl peroxide 2.5% for the
`once-daily treatment of moderate to severe acne vulgaris:
`Assessment of efficacy and safety in 2813 patients, 59 J. Am.
`Acad. Dermatol. 792 (2008) (“Thiboutot 2008”)
`Diane Thiboutot et al., New insights into the management of acne:
`An update from the Global Alliance to Improve Outcomes in Acne
`Group, 60 J. Am. Acad. Dermatol. S1 (2009) (“Thiboutot 2009”)
`Anja Thielitz and Harald Gollnick, Topical Retinoids in Acne
`Vulgaris – Update on Efficacy and Safety, 9 Am. J. Clin.
`Dermatol. 369 (2008) (“Thielitz”)
`Stephen Titus & Joshua Hodge, Diagnosis and Treatment of Acne,
`86 Am. Family Physician 734 (2012) (“Titus”).
`Physicians’ Desk Reference (2011) (excerpt)
`Physicians’ Desk Reference (2012) (excerpt)
`Epiduo Press Release (Dec. 15, 2011), available at
`https://www.galderma.com/us/news/1-branded-topical-acne-
`product-epiduo-gel-recieves-fda-approval-new-convenient-pump-
`dispenser
`Aczone 5% Medical Review(s) (excerpt)
`Aczone 5% Clinical Pharmacology and Biopharmaceutics
`Review(s)
`2008 Aczone 5% label
`
`5
`
`
`
`IPR2019-00207
`Patent Owner’s Updated Exhibit List
`
`
`Exhibit No.
`2045
`2046
`2047
`
`2048
`2049
`
`2050
`2051
`2052
`
`2053
`
`2054
`2055
`2056
`2057
`2058
`2059
`
`Description
`2005 Aczone 5% approval letter
`2008 Aczone 5% approval letter
`Siripen Puavilai et al., Incidence of Anemia in Leprosy Patients
`Treated with Dapsone, J. Med. Assoc. Thailand 67(7): 404-407
`(1984) (“Puavilai”)
`World Health Organization Alert No. 117
`Boyd Poulsen, Development Process in Topical Dosage Forms,
`AAPS/FDA Joint Workshop on Topical Product Development:
`Principles and Criteria for the Development and Optimization of
`Topical Therapeutic Products, Arlington, VA (Mar. 26, 1990)
`(“Poulsen”).
`FDA Inactive Ingredient Database (September 2012)
`FDA Inactive Ingredient Database (December 2012)
`European Commission’s Scientific Committee on Consumer
`Safety, Opinion on Diethylene Glycol Monoethyl Ether (DEGEE)
`(2010)
`U.S. Patent Application Publication No. 2007/0122435
`(“Osborne III”)
`2005 Aczone 5% label
`Declaration of Leon H. Kircik, M.D.
`Curriculum Vitae of Leon H. Kircik, M.D.
`Declaration of David W. Osborne, Ph.D.
`Curriculum Vitae of David W. Osborne, Ph.D.
`Ryan Gamble et al., Topical Antimicrobial Treatment of Acne
`Vulgaris, 13 Am. J. Clin. Dermatol. 3 (2012) (“Gamble”).
`
`6
`
`
`
`IPR2019-00207
`Patent Owner’s Updated Exhibit List
`
`
`Exhibit No.
`2060
`
`2061
`
`2062
`
`2063
`
`2064
`
`2065
`
`2066
`
`2067
`
`2068
`
`2069
`
`2070
`
`Description
`M. P. Heffernan et al., A Pilot Study of the Safety and Efficacy of
`Picolinic Acid Gel in the Treatment of Acne Vulgaris, 156 British
`J. Dermatol. 548 (2006) (“Heffernan”)
`Janusz Marcinkiewicz et al., Topical Taurine Bromamine,
`a New Candidate in the Treatment of Moderate Inflammatory
`Acne Vulgaris - A Pilot Study, 18 Eur. J. Dermatol. 433 (2008)
`(“Marcinkiewicz”)
`Transcript of Deposition of Elaine S. Gilmore, M.D., Ph.D., dated
`July 25, 2019
`Transcript of Deposition of Bozena B. Michniak-Kohn, Ph.D.,
`FAAPS, M.R.Pharm.S., dated July 30, 2019
`Rong-Kun Chang et al., Generic Development of Topical
`Dermatological Products: Formulation Development, Process
`Development, and Testing of Topical Dermatological Products,
`15 AAPS J. 41 (2012) (“Chang”)
`Supplemental Declaration of David W. Osborne, Ph.D. (served
`August 30, 2019)
`Erick H. Turner, How to access and process FDA drug approval
`packages for use in research, BMJ (2013) (“Turner 2013”) (served
`August 30, 2019)
`Manual of Policies and Procedures - Center for Drug Evaluation
`and Research (served August 30, 2019)
`Transcript of Deposition of Bozena B. Michniak-Kohn, Ph.D.,
`FAAPS, M.R.Pharm.S., dated December 6, 2019
`Transcript of Deposition of Elaine S. Gilmore, M.D., Ph.D., dated
`December 12, 2019
`Transcript of PTAB Conference Call, dated January 17, 2020
`
`7
`
`
`
`IPR2019-00207
`Patent Owner’s Updated Exhibit List
`
`
`Exhibit No.
`2071
`
`2072
`
`Description
`Joint Claim Construction Chart [Dkt. 53], filed March 2, 2020,
`Almirall, LLC v. Amneal Pharmaceuticals LLC, USDC, District of
`Delaware, Case No. 1:19-cv-00658-GJP (Redacted – Public
`Version)
`Joint Claim Construction Brief [Dkt. 110], filed June 15, 2020,
`Almirall, LLC v. Amneal Pharmaceuticals LLC, USDC, District of
`Delaware, Case No. 1:19-cv-00658-GJP (Redacted – Public
`Version)
`
`
`
`Dated: June 29, 2020
`
`
`
`
`
`
`Respectfully submitted,
`
`FENWICK & WEST LLP
`
`
`By:/James S. Trainor/
`James S. Trainor (Reg. No. 52,297)
`
`Attorneys for Patent Owner
`Almirall, LLC
`
`
`
`8
`
`
`
`IPR2019-00207
`Patent Owner’s Updated Exhibit List
`
`
`CERTIFICATE OF SERVICE
`
`Pursuant to 37 C.F.R. § 42.6, I hereby certify that on June 29, 2020, the
`
`foregoing PATENT OWNER’S UPDATED EXHIBIT LIST was served by
`
`electronic mail on the following counsel of record for Petitioners:
`
`Dennies Varughese
`Adam C. LaRock
`Tyler C. Liu
`Sterne, Kessler, Goldstein & Fox
`1100 New York Avenue, NW, Suite 600
`Washington, DC 20005
`dvarughe-PTAB@skgf.com
`alarock-PTAB@skgf.com
`tliu-PTAB@skgf.com
`
`
`Jitendra Malik
`Alissa M. Pacchioli
`Heike S. Radeke
`Katten Muchin Rosenman LLP
`550 S. Tryon Street, Suite 2900
`Charlotte, NC 28202-4213
`jitty.malik@kattenlaw.com
`alissa.pacchioli@kattenlaw.com
`heike.radeke@kattenlaw.com
`Lance Soderstrom
`Katten Muchin Rosenman LLP
`575 Madison Avenue
`New York, NY 10022-2585
`lance.soderstrom@kattenlaw.com
`
`Dated: June 29, 2020
`
`
`FENWICK & WEST LLP
`
`
`By:/James S. Trainor/
`James S. Trainor (Reg. No. 52,297)
`
`Attorneys for Patent Owner
`Almirall, LLC
`
`
`
`9
`
`
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