IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`COALITION FOR AFFORDABLE DRUGS X LLC,
`Petitioner,
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`v.
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`ANACOR PHARMACEUTICALS, INC.,
`Patent Owner.
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`Case No. IPR2015-01776
`Patent No. 7,582,621
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`PATENT OWNER’S IDENTIFICATION OF NEW
`ARGUMENTS AND EVIDENCE IN PETITIONER’S REPLY
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` DC: 6177693-6
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`COALITION FOR AFFORDABLE DRUGS X LLC,
`Petitioner,
`
`v.
`
`ANACOR PHARMACEUTICALS, INC.,
`Patent Owner.
`
`Case No. IPR2015-01776
`Patent No. 7,582,621
`
`PATENT OWNER’S IDENTIFICATION OF NEW
`ARGUMENTS AND EVIDENCE IN PETITIONER’S REPLY
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` DC: 6177693-6
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`IPR2015-01776
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`Pursuant to the Board’s September 20, 2016 e-mail authorization, Anacor
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`hereby provides a listing of new arguments and evidence in Petitioner’s Reply.
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`I.
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`Low MIC values and molecular weight in Austin alone provide a
`reasonable expectation of success.
`See Ex. 1044 ¶ 94, p. 62, l. 19–p. 63, l. 2 (“Therefore, based on the
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`disclosure of Austin alone, which shows very low MIC values associated with a
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`low molecular weight antifungal (tavaborole), a POSITA would have had a
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`reasonable expectation of successfully treating onychomycosis.”); Reply, p. 15, ll.
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`6–8 (“Tavaborole’s combination of low MIC values and low molecular weight
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`makes
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`it
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`the first compound
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`to choose from Austin for
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`treatment of
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`onychomycosis.”); Reply p. 18, ll. 2–4 (“A POSITA only needs to know the
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`molecular weight and MIC values of a compound to have a reasonable expectation
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`of success.”) (citing in part Ex. 1044 ¶ 94 (quoted above)); Reply p. 23, l. 4
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`(“Regardless, Austin discloses the activity of tavaborole, not Freeman”); cf.
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`Petition, Grounds 1–3, at iii; Petition p. 33, ll. 6–16; Petition p. 34, ll. 18–20;
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`Petition p. 47, ll. 3–7; Ex. 1008 ¶ 98, p. 32, ll. 6–17; Ex. 1008 ¶ 100, p. 33, ll. 5–8;
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`Ex. 1008 ¶ 127, p. 43, ll. 6–12; Ex. 1008 ¶ 132, p. 45, ll. 6–8.
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`II. Activity against C. albicans was predictive of activity against
`dermatophytes, and provides a reasonable expectation of success.
`See Reply p. 2, ll. 13–14 (“Antifungal activity against C. albicans furnishes
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`a reasonable expectation of success against dermatophytes.”); Reply p. 16, ll. 10–
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`1
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`IPR2015-01776
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`12 (“It was known in the art before 2005 that antifungal compounds with
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`fungicidal activity against C. albicans (a yeast) almost always had the same or
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`better activity against dermatophytes.”) (citing Mertin, Ex. 1065, as the only prior
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`art support in Section V); Ex. 1044 ¶ 89, p. 58, ll. 1–2 (“[I]f effectiveness against
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`yeasts (e.g., C. albicans) is known, a POSITA would reasonably expect
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`effectiveness against dermatophytes.”) (discussing Mertin); cf. Petition p. 40, l. 34–
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`p. 41, l. 12 (citing only Brehove for Claim 6’s limitation of treating tinea
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`unguium); Petition p. 37, ll. 8–18; Petition p. 54, ll. 13–26 (citing only Freeman for
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`Claim 6’s limitation of treating tinea unguium); Petition p. 49, ll. 7–11; Ex. 1008 ¶
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`98, p. 32, ll. 6–17; Ex. 1008 ¶ 130, p. 44, ll. 8–18.
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`III. Nail penetration was predictable based on molecular weight alone,
`irrespective of structural similarities between the compounds.
`See Reply p. 18, ll. 8–9 (“Mertin established that the ability of a compound
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`to penetrate the nail is directly proportional to its molecular weight.”); Reply p. 19,
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`ll. 16–18 (“The lower the molecular weight of a compound, the greater the ability
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`of the compound to penetrate the nail.”); Reply p. 19, ll. 5–9 (“Murdan …
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`concluded ‘molecular size has an inverse relationship with penetration into the nail
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`plate … .’”); cf. Petition p. 32, l. 18–p. 33, l. 1 (citing the “effective Brehove
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`compounds” for “successfully penetrating the nail”); Ex. 1008 ¶ 95, p. 31, ll. 4–9;
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`Petition p. 50, l. 3 (citing Freeman’s “compounds for treating and inhibiting
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`onychomycosis”); Ex. 1008 ¶ 134, p. 46, ll. 4–8.
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`2
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`IPR2015-01776
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`IV. Topical administration avoids toxicity.
`See Reply p. 10, ll. 12–14 (“Consistent with the prior art, Petitioner’s experts
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`concluded that boron toxicity would not be a concern in early 2005 when
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`developing a topical formulation for delivery to the nail.”); Reply p. 10, ll. 7–9
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`(“Dr. Reider failed to address the differences between oral or intravenous
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`administration versus topical administration”); Ex. 1044 ¶ 46, p. 24, ll. 1–3 (“I do
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`not believe that information regarding selective toxicity was necessary for the
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`selection of tavaborole for use in the topical treatment of onychomycosis”); cf.
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`Petition p. 34, ll. 1–4; Ex. 1008 ¶ 103, p. 34, l. 19–p. 35, l. 5; Ex. 1006 ¶ 44, p. 14,
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`ll. 12–13.
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`V.
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`Structural differences between the compounds of Austin and Freeman
`would have led a POSA to expect different biological activities.
`See Ex. 1043 ¶ 24, p. 14, l. 12–p. 15, l. 4 (“In contrast [to phenylboronic acid
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`from Freeman], the boron within the oxaboroles disclosed by Austin is confined
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`within the 5-membered ring. … This decreases the ‘promiscuity’ of boron because
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`the number of configurations boron can adopt is reduced by its location within the
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`ring … .”); Reply p. 13, ll. 14–16 (“PO’s arguments also fail to address that
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`boron’s location within the heterocycle of tavaborole reduces the ability of
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`tavaborole to interact indiscriminately.”) (citing Ex. 1043 ¶¶ 24–25); cf. Petition p.
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`48, l. 20–p. 49, l. 3; Ex. 1008 ¶ 127, p. 43, ll. 9–12.
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`3
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`IPR2015-01776
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`Date: September 27, 2016
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`Respectfully submitted,
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`fp,
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`—
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`tf)?
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`Andrea G.Reister/
`Registration No. 36,253
`COVINGTON & BURLING LLP
`One CityCenter, 850 Tenth Street, NW
`Washington, DC 20001
`(202) 662-6000
`Attorney for Patent Owner
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`
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`CERTIFICATE OF SERVICE
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`Pursuant to 37 C.F.R. § 42.6, I hereby certify that on this 27th day of
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`September 2016, the foregoing Patent Owner’s Identification of New Arguments
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`and Evidence In Petitioner’s Reply was served by electronic mail, by agreement of
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`the parties, on the following counsel of record for petitioner.
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`Jeffrey D. Blake
`Kathleen E. Ott
`Peter A. Gergely
`Ryan James Fletcher
`Brent E. Routman
`Merchant & Gould PC
`KerydinIPR@merchantgould.com
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`Date: September27, 2016
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`(bude
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`
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`Andrea G. ReiSter, Esq.
`Reg. No.: 36,253
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`
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