Served on behalf of Petitioner COALITION FOR AFFORDABLE DRUGS X LLC
`
`
`By: Jeffrey D. Blake, Esq.
` MERCHANT & GOULD P.C.
`
`191 Peachtree Street N.E., Suite 4300
` Atlanta, GA 30303
`
`jblake@merchantgould.com
` Main Telephone: (404) 954-5100
` Main Facsimile: (404) 954-509
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_____________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________________
`
`COALITION FOR AFFORDABLE DRUGS X LLC,
`Petitioner,
`
`v.
`
`ANACOR PHARMACEUTICALS, INC.,
`Patent Owner.
`___________________
`
`Case IPR2015-01776 (Patent 7,582,621 B2)
`____________________
`
`PETITIONER’S RESPONSE TO PATENT OWNER’S IDENTIFICATION
`OF NEW ARGUMENTS AND EVIDENCE IN PETITIONER’S REPLY
`
`
`
`
`
`
`
`
`By: Jeffrey D. Blake, Esq.
` MERCHANT & GOULD P.C.
`
`191 Peachtree Street N.E., Suite 4300
` Atlanta, GA 30303
`
`jblake@merchantgould.com
` Main Telephone: (404) 954-5100
` Main Facsimile: (404) 954-509
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_____________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________________
`
`COALITION FOR AFFORDABLE DRUGS X LLC,
`Petitioner,
`
`v.
`
`ANACOR PHARMACEUTICALS, INC.,
`Patent Owner.
`___________________
`
`Case IPR2015-01776 (Patent 7,582,621 B2)
`____________________
`
`PETITIONER’S RESPONSE TO PATENT OWNER’S IDENTIFICATION
`OF NEW ARGUMENTS AND EVIDENCE IN PETITIONER’S REPLY
`
`
`
`
`
`
`
`IPR2015-01776
`Patent 7,582,621
`
`
`I.
`
`“Austin alone provides a reasonable expectation of success”
`
`
`
`As argued by Petitioner, Austin discloses tavaborole as a preferred, low
`
`molecular weight (MW) compound with strong antifungal activity against Candida
`
`albicans, a known cause of onychomycosis. (Paper 1 at 1, 18-19, 28-29; Ex. 1002,
`
`at 37, Abstract; Ex. 1008 ¶¶61, 63-65, 95, 102, 134; Ex. 2032 at 128:8-18, 507:21-
`
`508:25). In view of overwhelming evidence establishing low MW as the primary
`
`factor predictive of nail penetration, Petitioner stated that Austin alone would
`
`furnish a reasonable expectation of successfully treating onychomycosis. (Ex. 1028
`
`at 9; Ex. 2041 at 62, 251; Ex. 2032 at 507:16-508:19, 514:13-516:2; Ex. 1064
`
`¶¶[0001], [0006], [0017].) However, Petitioner does not argue that claims 1-12 of
`
`U.S. Patent No. 7,582,621 are unpatentable over Austin alone (Paper 1 at 3, 8); the
`
`claims are unpatentable based on a 35 U.S.C. § 103 combination of references
`
`(Paper 24 at 4, 15-16; Paper 47 at 1-3, 21-23, 28).
`
`II. Antifungal activity against C. albicans is predictive of activity
`against dermatophytes
`
`
`
`As argued by Petitioner, Austin and Brehove disclose boron heterocycles
`
`with strong in vitro activity against C. albicans (Paper 1 at 28-29; Ex. 1002 at 37,
`
`Table 9; Ex. 1008 ¶¶63-65, 67) and Brehove discloses in vivo treatment of
`
`onychomycosis, typically caused by dermatophytes and C. albicans (Paper 1 at 29-
`
`32; Ex. 1003 ¶[0005]; Ex. 1006 ¶32; Ex. 1008 ¶¶70-72). Based on similar
`
`
`
`1
`
`
`
`IPR2015-01776
`Patents 7,582,621
`
`structural features and shared activity against C. albicans, Petitioner argued that
`
`tavaborole would be expected to share other activities with Brehove’s compounds,
`
`“such as the inhibition of additional fungi responsible for onychomycosis.”
`
`(Paper 1 at 35; Ex. 1008 ¶¶100-01; Ex. 2032 at 566:15-567:7.) Petitioner argued
`
`similarly with respect to Freeman. (Paper 1 at 45-48; Ex. 1008 ¶¶73-74, 76-77,
`
`133.) Dr. Murthy confirmed that most antifungals exhibit broad spectrum activity
`
`against different fungi, including dermatophytes and Candida species. (Ex. 2032 at
`
`531:8-535:21.) In response, PO argued that antifungal activity against C. albicans
`
`was not predictive of activity against dermatophytes (Paper 32 at 11, 44-46; Ex.
`
`2035 ¶¶63-64, 114, 123, 132). In rebuttal, Petitioner cited prior art showing that
`
`activity against C. albicans was indeed predictive of activity against
`
`dermatophytes, which are more sensitive to antifungals. (Paper 47 at 2, 16-17; Ex.
`
`2070 at 422, 425; Ex. 1044 ¶¶89-93; Ex. 1065 at 5-6; Ex. 1046 at 238:22-239:12.)
`
`III. Nail penetration is inversely related to molecular weight
`
`
`
`Petitioner never argued that nail penetration was based on molecular weight
`
`alone. Rather, Petitioner argued that nail penetration is inversely related to
`
`molecular weight, as shown by Murdan (citing Mertin & Lippold). (Paper 1 at 32,
`
`35-36; Ex. 1008 ¶¶95, 102; Ex. 2032 at 513:11-516:2; Ex. 1028 at 9-10.) In
`
`response, PO argued that nail penetration was unpredictable and required test data
`
`for numerous other factors. (Paper 32 at 47-49; Ex. 2036 ¶¶22-29.) In rebuttal,
`
`
`
`2
`
`
`
`IPR2015-01776
`Patents 7,582,621
`
`Petitioner cited prior art evidence, PO’s expert paper and PO’s exhibits, which
`
`establish molecular weight as the primary factor predictive of nail penetration.
`
`(Paper 47 at 17-21; Ex. 2041 at 62, 251; Ex. 1065 at 3; Ex. 1066 at 8.)
`
`IV. Topical administration minimizes toxicity concerns
`
`
`
`Petitioner argued that boron compounds were generally safe and that topical
`
`formulations could avoid the unacceptable risks associated with oral
`
`administration. (Paper 1 at 10, 19-20, 48; Ex. 1028 at 2; Ex. 1006 ¶¶30, 44; Ex.
`
`1008 ¶135.) In response, PO argued that boron compounds were toxic. (Paper 32 at
`
`11-17; Ex. 2034 ¶¶68, 96.) In rebuttal, Petitioner noted that PO’s exhibits were
`
`directed to high-dose oral and/or intravenous administration of boron (Paper 47 at
`
`3-10, 23; Ex. 1043 ¶¶12-23, 26), which is inapplicable to topical administration of
`
`boron (Ex. 2033 at 406:7-408:20; Ex. 1044 ¶46; Ex. 1028 at 21; Ex. 1050 at 2, 9).
`
`V.
`
`Structural differences between Austin and Freeman
`
`
`
`Petitioner never argued that the compounds of Austin and Freeman are not
`
`structurally similar. Rather, Petitioner argued that the boron-containing cyclic
`
`compounds of Austin and Freeman are structurally similar, which accounts for
`
`their similar biological activity. (Paper 1 at 48-51; Ex. 1008 ¶133.) In rebutting
`
`PO’s boron “promiscuity” arguments, Petitioner argued that the non-selective
`
`binding of boron is minimized where boron is confined within a 5-membered ring,
`
`as in tavaborole. (Paper 47 at 12-13; Ex. 2034 ¶36; Ex. 1043 ¶24.)
`
`
`
`3
`
`
`
`IPR2015-01776
`Patents 7,582,621
`
`
`
`
`
`
`
`
`
`Date: October 4, 2016
`
`
`
`
`
`
`
`
`
`Respectfully submitted,
`
`MERCHANT & GOULD, P.C.
`
`
`
`
`
`By:
`Jeffrey D. Blake, Esq. Reg. No. 58,884
`Kathleen E. Ott, Esq. Reg. No. 64,038
`Peter A. Gergely, Esq. (Pro Hac Vice)
`Ryan J. Fletcher, Esq., Ph.D. (Pro Hac Vice)
`Brent E. Routman, Esq. (Pro Hac Vice)
`Merchant & Gould P.C.
`191 Peachtree Street N.E., Suite 4300
`Atlanta, GA 30303
`Main Telephone: (404) 954-5100
`Main Facsimile: (404) 954-5099
`
`Counsel for Petitioner
`
`
`
`
`
`4
`
`
`
`IPR2015-01776
`Patents 7,582,621
`
`
`CERTIFICATE OF SERVICE
`
`Pursuant to 37 C.F.R. § 42.6(e), the undersigned certifies that on October 4,
`
`2016, a complete and entire copy of PETITIONER’S RESPONSE TO PATENT
`
`OWNER’S IDENTIFICATION OF NEW ARGUMENTS AND EVIDENCE IN
`
`PETITIONER’S REPLY was served by email, by agreement of the parties to:
`
`areister@cov.com; and
`elongton@cov.com.
`
`
`
`Respectfully submitted,
`
`MERCHANT & GOULD P.C.
`
`
`
`
` By:
`
`
`
`
`
` Counsel for Petitioner
`
`
`
`
`
`5
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