Paper _____
`
` Date filed: November 1, 207
`
`
`
` Filed on behalf of: Acrux DDS Pty Ltd. and Acrux Limited
`
`
`By: E. Anthony Figg, Lead Counsel
` Aydin H. Harston, Backup Counsel
` ROTHWELL, FIGG, ERNST & MANBECK, P.C.
` 607 14th St., N.W., Suite 800
`
` Washington, DC 20005
` Phone: 202-783-6040
` Fax: 202-783-6031
` Emails: efigg@rfem.com
`
`
`aharston@rfem.com
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_______________
`
`ACRUX DDS PTY LTD. AND ACRUX LIMITED,
`Petitioner,
`
`v.
`
`KAKEN PHARMACEUTICAL CO., LTD. and
`VALEANT PHARMACEUTICALS INTERNATIONAL, INC.,
`Patent Owner.
`_______________
`
`Case IPR2017-00190
`Patent 7,214,506 B2
`_______________
`
`
`PETITIONERS UPDATED EXHIBIT LIST
`
`
`
`
`
`
` 
`
` 
`
`

`

`Case IPR2017-00190
`Patent 7,214,506 B2 
`
`
`
`Further to 37 C.F.R. § 42.63(e), Petitioner Acrux DDS Pty Ltd. and Acrux
`
`Limited hereby submits a current listing of Petitioner exhibits.
`
`EXHIBIT
`1001
`1002
`
`1003
`
`1004
`
`1005
`1006
`
`1007
`1008
`1009
`
`1010
`1011
`
`1012
`
`1013
`1014
`
`1015
`
`DESCRIPTION
`U.S. Pat. No. 7,214,506 to Tatsumi et al. (“’506 Patent”)
`Japanese Pat. App. No. 11/214369 to Tatsumi et al. and
`Certified English Translation Thereof (“priority document”)
`Press Release: “Valeant Pharmaceuticals Announces FDA
`Approval of Jublia® for the Treatment of Onychomycosis”
`(Jun. 9, 2014)
`Orange Book Excerpt for Valeant’s Jublia® Product,
`“Approved Drug Products with Therapeutic Equivalence
`Evaluations” (accessed July 29, 2016)
`Declaration of Kenneth Walters (“Walters Decl.”)
`Prosecution History of U.S. Pat. No. 7,214,506 (June 14,
`2006)
`U.S. Pat. No. 5,620,994 to Naito et al.
`U.S. Pat. No. 5,716,969 to Naito et al.
`Comparison between the Priority Document (see Ex. 1002)
`and U.S. Pat. App. No. 10/685,266 (“’266 application”)
`Publication of PCT/JP00/04617 (filed July 11, 2000).
`Japanese Pat. App. Pub. No. 10-226639 (“JP ’639”) and
`Certified English Translation Thereof
`“Synthesis and Antifungal Activities of (2R,3R)-2-Aryl-1-
`azolyl-3-(substituted amino)-2-butanol Derivatives ad Topical
`Antifungal Agents.” Ogura, H. et al., Chem. Pharm. Bull,
`47(10) 1417-1425 (1999) (“Ogura”)
`U.S. Pat. No. 5,391,367 to DeVincentis (“’367 Patent”)
`“Tioconazole nail solution—an open study of its efficacy in
`onychomycosis.” Hay, R.J., et al., Clinical and Experimental
`Dermatology, 10:111-115 (1985) (“Hay”)
`Abstracts F78, F79 and F80 from Abstracts of the Interscience
`Conference on Antimicrobial Agents and Chemotherapy
`(ICAAC), 36th ICAAC, held on September 15-18, 1996 (1996)
`(“Kaken Abstracts”)
`
` 
`
`2
`
`

`

`Case IPR2017-00190
`Patent 7,214,506 B2 
`
`EXHIBIT
`1016
`
`1017
`
`1018
`
`1019
`
`1020
`
`1021
`
`1022
`
`1023
`
`DESCRIPTION
`“Bioavailability, skin- and nail penetration of topically applied
`antimycotics.” Stuttgen, G. and Bauer, E., Mykosen, 25(2): 74-
`80 (1992) (“Stuttgen and Bauer”)
`“Ciclopirox nail lacquer 8%: in vivo penetration into and
`through nails and in vitro effect on pig skin.” Ceschin-Roques
`C.G., et al., Skin Pharmacol, 4: 89-94 (1991) (“Ceschin-
`Roques”)
`“Absorption of amorolfine through human nail.” Franz, T.J.,
`Dermatol, 184(Suppl 1): 18-20 (1992) (“Franz”)
`“Nail penetration of the antifungal oxiconazole after repeated
`topical application in healthy volunteers, and the effect of
`acetylcysteine.” van Hoogdalem, E.J. et al., Eur J Pharm Sci 5:
`119-127 (1997) (“van Hoogdalem”)
`“The effect of keratolytic agents on the permeability of three
`imidazole antimycotic drugs through the human nail.”
`Quintanar-Guerrero, D. et al., Drug Dev Ind Pharm, 24: 685-
`690 (1998) (“Quintanar-Guerrero”)
`“In vitro permeability of the human nail and of a keratin
`membrane from bovine hooves: Influence of the partition
`coefficient octanol/water and the water solubility of drugs on
`their permeability and maximum flux.” Mertin, D. and
`Lippold, B.C., Journal of Pharmacy and Pharmacology,
`49(1): 30-34 (1997) (“Merton and Lippold I”)
`“In vitro permeability of the human nail and of a keratin
`membrane from bovine hooves: Penetration of
`chloramphenicol from lipophilic vehicles and a nail lacquer.”
`Mertin, D. and Lippold, B.C., Journal of Pharmacy and
`Pharmacology, 49(3): 241-245 (1997) (“Mertin and Lippold
`II”)
`“In vitro permeability of the human nail and of a keratin
`membrane from bovine hooves: Prediction of the penetration
`rate of antimycotics through the nail plate and their efficacy.”
`Mertin, D. and Lippold, B.C., Journal of Pharmacy and
`Pharmacology, 49(9): 866-872 (1997) (“Mertin and Lippold
`III”)
`
` 
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`3
`
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`Case IPR2017-00190
`Patent 7,214,506 B2 
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`EXHIBIT
`1024
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`1025
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`1027
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`1028
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`1029
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`1030
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`1031
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`1033
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`1034
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`1035
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`1036
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`DESCRIPTION
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`mercaptoethanol on the in vitro permeation of 5-fluorouracil or
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`Chem Pharm Bull 46: 1797-1802 (1998) (“Kobayashi”)
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`“The azole antifungal drugs.,” Hay, R.J., Journal of
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`“Amorolfine nail lacquer: a novel formulation.” Marty, J.L.,
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`R.C., Dermatology, 194 (Supp. 1): 32-36 (1997)
`(“Summerbell”)
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`Practice, 38(6): 601-605 (1994) (“Buck”)
`
` 
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`4
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`Case IPR2017-00190
`Patent 7,214,506 B2 
`
`EXHIBIT
`1037
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`1038
`
`1039
`
`1040
`
`1041
`
`1042
`
`1043
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`1044
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`1045
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`“Amorolfine- A Review of its Pharmacological Properties and
`Therapeutic Potential in the Treatment of Onychomycosis and
`Other Superficial Fungal Infections.” Haria, M. and Bryson,
`H.M., Drugs, 49(1): 103-120 (1995) (“Haria”)
`“Measurement of water vapor loss through human nail in
`vivo.” Spruit, D., J Invest Dermatol, 56(5): 359-361 (1971)
`(“Spruit”)
`“Bioavailability, skin and nail penetration of topically applied
`antimycotics.” Stuttgen, G. and Bauer, E., Mycoses 25: 74-80
`(1982) (“Stuttgen and Bauer”)
`“Physicochemical characterization of the human nail: I.
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`Invest Dermatol, 76: 76-79 (1981) (“Walters 1981”)
`“Physicochemical characterization of the human nail:
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`K.A., Flynn, G.L. and Marvel, J.R., J Pharm Pharmacol 35:
`28-33 (1983) (“Walters 1983”)
`“Penetration of the human nail: the effects of vehicle pH on
`the permeation of miconazole.” Walters, K.A., Flynn, G.L. and
`Marvel, J.R., J Pharm Pharmacol, 37: 498-499 (1985)
`(“Walters 1985 I”)
`“Physicochemical characterization of the human nail: solvent
`effects on the permeation of homologous alcohols.” Walters,
`K.A., Flynn, G.L. and Marvel, J.R., J Pharm Pharmacol, 37:
`771-775 (1985) (“Walters 1985 II”)
`Jublia® (efinaconazole) topical solution, 10% [package insert].
`Shizuoka, Japan: Kaken Pharmaceutical Co. Ltd; 2014
`About Acrux http://www.acrux.com.au/about (Accessed
`10/27/2016)
`Acrux Product Pipeline http://www.acrux.com.auwhat-we-
`do/research-developement-pipeline/ (Accessed 10/27/2016)
`Reissue Preliminary Statement from Prosecution History of In
`Re Reissue Application of U.S. Pat. No. 7,214,506
`(01/12/2017)
`
` 
`
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`

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`
`EXHIBIT
`1500
`
`1501
`
`1502
`
`1503
`
`1504
`
`1505
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`23(2): 305-313 (1996)
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`36(1): 7-12 (1995)
`“Guidelines for treatment of onychomycosis.” D.T. Roberts et
`al., British Journal of Dermatology, 148(1): 402-410 (2003)
`Meeting Minutes for IND 77732, Division of Dermatology and
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`U.S. Pat. No. 5,962,476 to Naito et al. (“’476 Patent”)
`Deposition Transcript of Dr. Yoshiyuki Tatsumi (October 11,
`2017) FILED UNDER SEAL, PUBLIC VERSION ALSO
`FILED
`Deposition Transcript of Vincent A. Thomas (October 13,
`2017) FILED UNDER SEAL, PUBLIC VERSION ALSO
`FILED
`Deposition Transcript of Dr. Boni E. Elewski (October 20,
`2017)
`Declaration of Kenneth A. Walters, Ph.D. in Support of
`Petitioner’s Reply to Patent Owner’s Response
`Declaration of Jeffrey M. Weinberg, M.D. in Support of
`Petitioner’s Reply to Patent Owner’s Response
`Declaration of John C. Staines, Jr. in Support of Petitioner’s
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`PUBLIC VERSION ALSO FILED
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`Dermatology, 52 (3): 545-549 (1990) (Japanese Original and
`Certified English Translation)
`
` 
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`1514
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`
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`Georgiev ed.), 544: 414-426 (1988)
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`
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`
` 
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`Case IPR2017-00190
`Patent 7,214,506 B2 
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`EXHIBIT
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`of ‘Massive Fraud’,” M. Petersen and S. Pfeifer, Los Angeles
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`
` 
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`Case IPR2017-00190
`Patent 7,214,506 B2 
`
`EXHIBIT
`1546
`
`1547
`
`1548
`
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`
`1550
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`
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`
` 
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`11
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`

`Case IPR2017-00190
`Patent 7,214,506 B2 
`
`EXHIBIT
`1553
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`1554
`
`1555
`
`1556
`
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