`
`
`
`
`
`
`
`
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`Filed: August 1, 2017
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`
`ACRUX DDS PTY LTD. & ACRUX LIMITED
`Petitioners,
`
`v.
`
`KAKEN PHARMACEUTICAL CO., LTD. and
`VALEANT PHARMACEUTICALS INTERNATIONAL, INC.
`Patent Owner and Licensee.
`
`
`
`Case: IPR2017-00190
`U.S. Patent No. 7,214,506
`
`
`
`PATENT OWNER’S UPDATED EXHIBIT LIST
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Further to 37 C.F.R. § 42.63(e), Patent Owner Kaken Pharmaceutical Co.,
`
`Case IPR2017-00190
`Patent No. 7,214,506
`
`
`Ltd. hereby submits a current listing of Kaken exhibits.
`
`EXHIBIT
`
`DESCRIPTION
`
`2001
`
`2002
`
`2003
`
`2004
`
`2005
`
`2006
`
`2007
`
`2008
`
`2009
`
`2010
`
`2011
`
`Declaration of Yoshiyuki Tatsumi (Japanese)
`
`Research and Development Activity Report, dated
`May 28, 1999 (Japanese)
`
`Declaration of Yoshiyuki Tatsumi (English)
`
`Research and Development Activity Report, dated
`May 28, 1999 (English)
`
`Certificate of Translation: Declaration of Yoshiyuki
`Tatsumi
`
`Certificate of Translation: Research and Development
`Activity Report
`
`Richard K. Scher & Lisa M. Coppa, Advances in the
`Diagnosis and Treatment of Onychomycosis, 34 HOSP.
`MED. 11 (1998)
`
`Robert Baran et al., ONYCHOMYCOSIS: THE CURRENT
`APPROACH TO DIAGNOSIS AND THERAPY (1999)
`
`Markus Niewerth & Hans C. Korting, Management of
`Onychomycoses, 58 DRUGS 283 (1999)
`
`Boni E. Elewski, Onychomycosis: Pathogenesis, Diagnosis,
`and Management, 11 CLINICAL MICROBIOLOGY
`REVS. 415 (1998)
`
`Bradley D. Castellano, Chapter 23: Tinea Pedis and
`Onychomycosis: Overview of New Systemic Therapies, in
`RECONSTRUCTIVE SURGERY OF THE FOOT AND
`LEG (Nancy S. Vickers, ed., 1997)
`
`
`
`2
`
`
`
`EXHIBIT
`
`2012
`
`2013
`
`2014
`
`2015
`
`2016
`
`2017
`
`2018
`
`2019
`
`Case IPR2017-00190
`Patent No. 7,214,506
`
`
`DESCRIPTION
`
`Gouri V. Gupchup & Joel L. Zatz, Structural
`Characteristics and Permeability Properties of the Human
`Nail: A Review, 50 J. COSMETIC SCI. 363 (1999)
`
`Antonella Tosti & Bianca M. Piraccini, Chapter 18:
`Biology of Nails, in FITZPATRICK’S DERMATOLOGY IN
`GENERAL MEDICINE VOL. 1 (Irwin M. Freedberg et al., eds.,
`5th ed. 1999)
`
`Yoichi Kobayashi et al., Drug Permeation Through the
`Three Layers of the Human Nail Plate, 51 J. PHARMACY
`& PHARMACOLOGY 271 (1999)
`
`Sudaxshina Murdan, Drug Delivery to the Nail Following
`Topical Application, 236 INT’L J. PHARMACEUTICALS
`1 (2002)
`
`Yoshiyuki Tatsumi et al., Therapeutic Efficacy of Topically
`Applied KP-103 Against Experimental Tinea Unguium in
`Guinea Pigs in Comparison with Amorolfine and
`Terbinafine, 46 ANTIMICROBIAL AGENTS &
`CHEMOTHERAPY 3797 (2002)
`
`James Q. Del Rosso, The Role of Topical Antifungal
`Therapy for Onychomycosis and the Emergence of Newer
`Agents, 7 J. CLINICAL & AESTHETIC DERMATOLOGY
`10 (2014)
`
`Brian McCurdy, The Top Ten Innovations in Podiatry, 26
`PODIATRY TODAY 1 (2013), http://www.podiatrytoday
`.com/top-ten-innovations- podiatry-1
`
`Kenneth A. Walters et al., Physicochemical
`Characterization of the Human Nail: Solvent Effects on the
`Permeation of Homologous Alcohols, 37 J. OF
`PHARMACY & PHARMACOLOGY 771 (1985)
`
`
`
`3
`
`
`
`Case IPR2017-00190
`Patent No. 7,214,506
`
`
`DESCRIPTION
`
`Kenneth A. Walters et al., Physicochemical
`Characterization of the Human Nail: Permeation Pattern
`for Water and the Homologous Alcohols and Differences
`with Respect to the Stratum Corneum, 35 JOURNAL OF
`PHARMACY & PHARMACOLOGY 28 (1983)
`
`Kenneth A. Walters, Chapter 22: Ungual Formulations:
`Topical Treatment of Nail Diseases, in TREATMENT OF
`DRY SKIN SYNDROME: THE ART AND SCIENCE OF
`MOISTURIZERS (Marie Lodén & Howard I. Maibach,
`eds., 2012)
`
`Acrux Files New Intellectual Property Application for
`Onychomycosis Product, ACRUX (Nov. 2, 2016),
`http://www.asx.com.au/asxpdf/20161102/pdf/43cldkvypcq
`j00.pdf
`
`Declaration of Barbara R. Rudolph, Ph.D. in Support of
`Patent Owner’s Unopposed Motion for Pro Hac Vice
`Admission
`
`Second Declaration of Yoshiyuki Tatsumi (Japanese)
`
`Second Declaration of Yoshiyuki Tatsumi (English)
`
`Certificate of Translation: Second Declaration of Yoshiyuki
`Tatsumi
`
`Declaration of Boni E. Elewski, M.D.
`
`Declaration of Vince Thomas
`
`Robert Langreth & Matthew Herper, Pill Pushers: How the
`drug industry abandoned science for salesmanship,
`FORBES, May 8, 2006, at 94
`
`Laboratory Notebook 1992-1993 (Japanese)
`
`Laboratory Notebook 1992-1993 (English)
`
`EXHIBIT
`
`2020
`
`2021
`
`2022
`
`2023
`
`2024
`
`2025
`
`2026
`
`2027
`
`2028
`
`2029
`
`2030
`
`2031
`
`
`
`4
`
`
`
`EXHIBIT
`
`DESCRIPTION
`
`Case IPR2017-00190
`Patent No. 7,214,506
`
`
`2032
`
`2033
`
`2034
`
`2035
`
`2036
`
`2037
`
`2038
`
`2039
`
`2040
`
`2041
`
`2042
`
`2043
`
`2044
`
`Certificate of Translation: Laboratory Notebook 1992-1993
`
`Laboratory Notebook 1993 (Japanese)
`
`Laboratory Notebook 1993 (English)
`
`Certificate of Translation: Laboratory Notebook 1993
`
`Abstract F790 from Abstracts of the 36th Interscience
`Conference on Antimicrobial Agents and Chemotherapy
`held on September 15-18, 1996 (1996)
`
`Abstract F792 from Abstracts of the 36th Interscience
`Conference on Antimicrobial Agents and Chemotherapy
`held on September 15-18, 1996 (1996)
`
`Abstract F793 from Abstracts of the 36th Interscience
`Conference on Antimicrobial Agents and Chemotherapy
`held on September 15-18, 1996 (1996)
`
`Research and Development Activity Report, dated May 28,
`1999 (Japanese)
`
`Corrected Research and Development Activity Report,
`dated May 28, 1999 (English)
`
`Certificate of Translation: Corrected Research and
`Development Activity Report, dated May 28, 1999
`
`May 21, 1999 Data Entitled “Effectiveness on guinea pig
`onychomycosis” (Japanese)
`
`May 21, 1999 Data Entitled “Effectiveness on guinea pig
`onychomycosis” (English)
`
`Certificate of Translation: May 21, 1999 Data Entitled
`“Effectiveness on guinea pig onychomycosis”
`
`
`
`5
`
`
`
`EXHIBIT
`
`DESCRIPTION
`
`Case IPR2017-00190
`Patent No. 7,214,506
`
`
`2045
`
`2046
`
`2047
`
`2048
`
`2049
`
`2050
`
`2051
`
`2052
`
`2053
`
`2054
`
`2055
`
`Tatsumi Research and Development Activity Report, dated
`May 26, 1999 (Japanese)
`
`Tatsumi Research and Development Activity Report, dated
`May 26, 1999 (English)
`
`Certificate of Translation: Tatsumi Research and
`Development Activity Report, dated May 26, 1999
`
`Xiaoying Hui et al., In Vitro Penetration of a Novel
`Oxaborole Antifungal (AN2690) into the Human Nail Plate,
`96 J. PHARM. SCIENCES 2622 (2007)
`
`Keita Sugiura et al., The Low Keratin Affinity of
`Efinaconazole Contributes to Its Nail Penetration and
`Fungicidal Activity in Topical Onychomycosis Treatment,
`58 ANTIMICROB. AGENTS CHEMOTHER. 3837 (2014)
`
`Transcript of Deposition of Kenneth Walters
`
`Rania Elkeeb et al., Transungual Drug Delivery: Current
`Status, 384 INT’L J. PHARMACEUTICALS 1 (2010)
`
`B.E. Elewski et al., Efficacy, safety and tolerability of
`topical terbinafine nail solution in patients with mild-to-
`moderate toenail onychomycosis: results from three
`randomized studies using double-blind vehicle-controlled
`and open-label active-controlled designs, 27 JEADV 287
`(2013)
`
`Penlac® Label, FDA, Approved Dec. 17, 1999
`
`Jublia® Label, FDA, Approved Jun. 6, 2014
`
`Shari Lipner & Richard Scher, Efinaconazole in the
`Treatment of Onychomycosis, 8 INFECTION AND DRUG
`RESISTANCE 163 (2015)
`
`
`
`6
`
`
`
`EXHIBIT
`
`2056
`
`2057
`
`2058
`
`2059
`
`2060
`
`2061
`
`2062
`
`2063
`
`Case IPR2017-00190
`Patent No. 7,214,506
`
`
`DESCRIPTION
`
`Mahmoud Ghannoum & Nancy Isham, Fungal Nail
`Infections (Onychomycosis): A Never-Ending Story? 10
`PLOS PATHOGENS 1 (2014)
`
`Mustafa Elsayed, Development of Topical Therapeutics for
`Management of Onychomycosis and Other Nail Disorders:
`A Pharmaceutical Perspective, 199 J. CONTROLLED
`RELEASE 132 (2015)
`
`David C. Holzman, Freely Diffusing Topical Antifungal
`Agent Fixes Infected Toenails, 9 MICROBE 267 (2014)
`
`Press Release, The Galien Foundation Announces 2015
`Prix Galien USA Nominees for “Best Biotechnology
`Product,” “Best Pharmaceutical Agent,” and “Best
`Medical Technology” (Aug. 6, 2015), available at
`http://www.prnewswire.com/news-releases/the-galien-
`foundation-announces-2015-prix-galien-usa-nominees-for-
`best-biotechnology-product-best-pharmaceutical-agent-and-
`best-medical-technology-300124894.html (last visited Aug.
`1, 2017).
`
`Phillip Rodgers & Mary Bassler, Treating Onychomycosis,
`63 AM. FAM. PHYSICIAN 663 (2001)
`
`Reserved
`
`Elaine Fuchs, Keratins and the Skin, 11 ANNUAL REV. CELL
`DEV. BIOL. 123 (1995)
`
`Superbrands: A Special Report, Brandweek (Jun. 21,
`2004), http://brandautopsy.typepad.com/superbrands_2004
`_brandweek.pdf (last visited Aug. 1, 2017)
`
`
`
`7
`
`
`
`EXHIBIT
`
`2064
`
`2065
`
`2066
`
`2067
`
`2068
`
`2069
`
`2070
`
`2071
`
`2072
`
`Case IPR2017-00190
`Patent No. 7,214,506
`
`
`DESCRIPTION
`
`Securities and Exchange Commission Form 20-F for
`Aventis for the fiscal year ended Dec. 31, 2003,
`https://www.sec.gov/ Archives/edgar/data/807198/
`000104746904006848/a2128888z20-f.htm (last visited
`Aug. 1, 2017)
`
`Daniéle Debruyne & Antoine Coquerel, Pharmacokinetics
`of Antifungal Agents in Onychomycoses, 40 CLIN.
`PHARMACOKINET. 441 (2001)
`
`Vagistat® Label, FDA, Approved Feb. 6, 1997
`
`Monistat® Label, FDA, Approved Mar. 30, 1998
`
`Gyne-Lotrimin® Label, FDA, Approved Nov. 24, 1998
`
`Jill Ferrari, Fungal Toenail Infections, 12 CLINICAL
`EVIDENCE 1 (2008)
`
`Yoshiki Matsuda, et al., Efficacy Coefficients Determined
`Using Nail Permeability and Antifungal Activity in Keratin-
`Containing Media are Useful for Predicting Clinical
`Efficacies of Topical Drugs for Onychomycosis, 11 PLOS
`ONE 1 (2016)
`
`Chris G. Adigun, Onychomycosis (Tinea Unguium), Merck
`Manual, available at https://www.merckmanuals.com/
`professional/dermatologic-disorders/nail-
`disorders/onychomycosis (last visited Aug. 1, 2017)
`
`Dyanne P. Westerberg & Michael J. Voyack,
`Onychomycosis: Current Trends in Diagnosis and
`Treatment, 88 AMERICAN FAMILY PHYSICIAN 762 (2013)
`
`
`
`8
`
`
`
`EXHIBIT
`
`2073
`
`2074
`
`2075
`
`2076
`
`2077
`
`2078
`
`2079
`
`2080
`
`Case IPR2017-00190
`Patent No. 7,214,506
`
`
`DESCRIPTION
`
`Boni Elewski et al., Efficacy and safety of tavaborole
`topical solution, 5%, a novel boron-based antifungal agent,
`for the treatment of toenail onychomycosis: Results from 2
`randomized phase-III studies, 73 J. AMERICAN ACAD.
`DERMATOL. 62 (2015)
`
`Boni Elewski, Tinea capitis: A current perspective, 42 J.
`AM. ACAD. DERMATOL. 1 (2000)
`
`Chapter 206: Superficial Fungal Infection:
`Dermatophytosis, Tinea Nigra, Piedra; Chapter 247:
`Topical Antifungal Agents; and Chapter 260: Oral
`Antifungal Agents, in FITZPATRICK’S DERMATOLOGY IN
`GENERAL MEDICINE VOL. 11 (Irwin M. Freedberg et al.,
`eds., 5th ed. 1999)
`
`Jacques F.G.M Meis & Paul E. Verweij, Current
`Management of Fungal Infections, 61 Supp. 1 DRUGS 13
`(2001)
`
`Piet De Doncker et al., Antifungal Pulse Therapy for
`Onychomycosis, 132 ARCH. DERMATOL. 34 (1996)
`
`R. Baran et al., A New Classification of Onychomycosis,
`139 BRITISH J. OF DERMATOL. 567 (1998)
`
`Greg Gargiulo, Onychomycosis Remains a Major Clinical
`Challenge (Nov. 2014), available at
`http://lermagazine.com/article/onychomycosis-remains-a-
`major-clinical-challenge (last visited Aug. 1, 2017)
`
`Anahad O’Connor, Ask Well: Leaving Nail Fungus
`Untreated, The New York Times online (Oct. 11, 2013),
`available at
`https://well.blogs.nytimes.com/2013/10/11/ask-well-
`leaving-nail-fungus-untreated/ (last visited Aug. 1, 2017)
`
`
`
`9
`
`
`
`EXHIBIT
`
`2081
`
`2082
`
`2083
`
`2084
`
`2085
`
`2086
`
`2087
`
`2088
`
`Case IPR2017-00190
`Patent No. 7,214,506
`
`
`DESCRIPTION
`
`Jennifer Acosta Scott, The Dangers of Ignoring Toenail
`Fungal Infections (Sep. 8, 2014), available at
`http://www.everydayhealth.com/hs/toenail-fungal-
`infection-guide/dangers-of-ignoring-toenail-fungal-
`infections/ (last visited Aug. 1, 2017)
`
`E. Gauthier et al., A Novel Method to Study Drug
`Permeation Through the Human Nail Plate, 7A
`PERSPECTIVES IN PERCUTANEOUS PENETRATION 69 (2000)
`
`Darren M. Green et al., Chapter 28: Nail Delivery, in
`Modified-Release Drug Delivery Technology, Second Ed.,
`Vol. 2 (Michael J. Rathbone et al., eds., 2008)
`
`Aditya K. Gupta & Catherine Studholme, Update on
`Efinaconazole 10% Topical Solution of Onychomycosis, 21
`SKIN THERAPY LETTER 6 (2016)
`
`Aditya K. Gupta, Efinaconazole: A New Topical Treatment
`for Onychomycosis, 19 SKIN THERAPY LETTER 1 (2014)
`
`B.S. Barot et al., Drug Delivery to the Nail: Therapeutic
`Options and Challenges for Onychomycosis, 31 CRIT. REV.
`THER. DRUG CARRIER SYS. 459 (2014) (abstract)
`
`Nail Fungus Treatment, Mayo Clinic, available at
`http://www.mayoclinic.org/diseases-conditions/nail-
`fungus/diagnosis-treatment/treatment/txc-20342485 (last
`visited Aug. 1, 2017)
`
`Kristine Hoffman, A Closer Look at a New Topical Option
`for Onychomycosis, Podiatry Today (Oct. 1, 2014),
`available at http://www.podiatrytoday.com/blogged/closer-
`look-new-topical-option-onychomycosis (last visited Aug.
`1, 2017)
`
`2089
`
`Warren Joseph et al., Onychomycosis and the Role of
`Topical Antifungals, Suppl. to Podiatry Today (Nov. 2013)
`
`
`
`10
`
`
`
`Case IPR2017-00190
`Patent No. 7,214,506
`
`
`DESCRIPTION
`
`Kaken Pharmaceuticals, Clenafin, available at
`http://www.kaken.co.jp/english/business/top12.html (last
`visited Aug. 1, 2017)
`
`Jublia® Website, available at http://www.jubliarx.com/
`(last visited Aug. 1, 2017)
`
`Press Release, Valeant Pharmaceuticals Announces FDA
`Approval of Jublia® for the Treatment of Onychomycosis,
`(Jun. 9, 2014), available at http://ir.valeant.com/news-
`releases/2014/09-06-2014
`
`Jublia® Commericial Market Comparison, Jan. 26, 2017
`(CONFIDENTIAL - PROTECTIVE ORDER MATERIAL)
`
`Jublia® Monthly TRx, NRx Data for US 2017
`(CONFIDENTIAL - PROTECTIVE ORDER MATERIAL)
`
`Jublia® Data dated May 31, 2017 (CONFIDENTIAL -
`PROTECTIVE ORDER MATERIAL)
`
`Protective Order
`
`Declaration of Ashley Winkler
`
`Jublia Sales (CONFIDENTIAL - PROTECTIVE ORDER
`MATERIAL)
`
`U.S. Onychomycosis Prescriptions (CONFIDENTIAL -
`PROTECTIVE ORDER MATERIAL)
`
`EXHIBIT
`
`2090
`
`2091
`
`2092
`
`2093
`
`2094
`
`2095
`
`2096
`
`2097
`
`2098
`
`2099
`
`Dated: August 1, 2017
`
`
`
`
`
`Respectfully submitted,
`
`
`By: / John D. Livingstone /
`John D. Livingstone, Reg. No. 59,613
`FINNEGAN, HENDERSON, FARABOW,
` GARRETT & DUNNER, LLP
`Lead Counsel for Patent Owner
`
`11
`
`
`
`CERTIFICATE OF SERVICE
`
`Case IPR2017-00190
`Patent No. 7,214,506
`
`
`The undersigned certifies that a copy of the foregoing Patent Owner’s
`
`Updated Exhibit List and Exhibits 2024-2060 and 2062-2099 were served
`
`electronically via email on August 1, 2017, in its entirety on the following:
`
`E. Anthony Figg
`Rothwell, Figg, Ernst & Manbeck, P.C.
`607 14th Street, N.W., Suite 800
`Washington, DC 20005
`efigg@rothwellfigg.com
`litigationparalegals@rothwellfigg.com
`
`Aydin H. Harston
`Rothwell, Figg, Ernst & Manbeck, P.C.
`607 14th Street, N.W., Suite 800
`Washington, DC 20005
`aharston@rothwellfigg.com
`litigationparalegals@rothwellfigg.com
`
`
`By: / John D. Livingstone /
`John D. Livingstone
`Reg. No. 59,613
`
`
`
`
`
`
`
`
`
`
`
`