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 MOTION FOR OBSERVATIONS
`REGARDING THE CROSS-EXAMINATION
`TESTIMONY OF S. NARASIMHA MURTHY, Ph.D.
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` DC: 6177793-1
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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 MOTION FOR OBSERVATIONS
`REGARDING THE CROSS-EXAMINATION
`TESTIMONY OF S. NARASIMHA MURTHY, Ph.D.
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` DC: 6177793-1
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`IPR2015-01776
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`I.
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`Introduction
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`In accordance with: (i) The Trial Practice Guide, Federal Register Vol. 77,
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`No. 157, 48756 at 48767–68 and (ii) the Scheduling Order (Paper No. 25) as
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`modified by the Joint Notice of Stipulation to Adjust Schedule (Paper No. 28) and
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`the Second Joint Notice of Stipulation to Adjust Schedule (Paper No. 31), Patent
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`Owner hereby submits the instant Motion for Observations Regarding the Cross-
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`Examination Testimony of S. Narasimha Murthy, Ph.D. taken on September 17,
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`2016. The transcript of this testimony has been filed as Exhibit 2207.
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`Patent Owner requests that the Board enter the instant Motion and consider
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`the observations. Observations 1–14 below pertain to the deposition testimony of
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`S. Narasimha Murthy, Ph.D., obtained on September 17, 2016, after Patent Owner
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`filed its last substantive paper. In addition, and in accordance with the Trial Guide,
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`each of observations 1–14 below provides in a single paragraph a concise
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`statement of the relevance of the precisely identified testimony to a precisely
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`identified argument.
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`II. Observations
`In Ex. 2207 at 656:12-657:24, Dr. Murthy affirmed that the Austin
`1.
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`reference alone provides a
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`reasonable expectation of success
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`to
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`treat
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`onychomycosis and stated, “[t]he information that’s -- that’s provided in Austin is
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`all what [sic] a POSITA would need to -- to take the molecule further and develop
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`1
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`IPR2015-01776
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`a potential medication for the treatment of onychomycosis.” At 711:11-14, Dr.
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`Murthy testified that “my position is that the POSA could just look at the Austin
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`and have a reasonable expectation of success using tavaborole to treat
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`onychomycosis.” This testimony is relevant because this argument was not in the
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`Petition and constitutes a new alleged ground of invalidity presented for the first
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`time with Petitioner’s Reply To Patent Owner’s Response (“Reply,” Paper No. 47).
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`2.
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`In Ex. 2207 at 658:20-665:15, Dr. Murthy testified that Austin alone
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`discloses every individual limitation of Claims 1, 4 & 6 of the ’621 Patent. This
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`testimony is relevant because this argument was not in the Petition and constitutes
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`a new alleged ground of invalidity presented for the first time with Petitioner’s
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`Reply.
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`3.
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`In Ex. 2207 at 716:16-717:1, Dr. Murthy testified that the ’621 Patent
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`discloses tavaborole “for treating onychomycosis,” but Austin discloses the
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`compound “for some other purpose,” i.e., “industrial biocides.” At 723:11-19, Dr.
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`Murthy testified that “the protection of plastics from -- from fungal -- fungal
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`growth” was the problem that the inventors of Austin were trying to solve. This
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`testimony is relevant because of Dr. Murthy’s prior assertion that Austin is
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`analogous art to the ’621 Patent. See Ex. 1044 ¶¶ 42-43; Reply pp. 2 & 11-12.
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`4.
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`In Ex. 2207 at 651:23-24, Dr. Murthy testified, “I’m not an expert in
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`mycology.” This testimony is relevant because Dr. Murthy’s obviousness analysis
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`2
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`IPR2015-01776
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`relies on mycological arguments. See, e.g., Ex. 1044 ¶ 88 (arguing that
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`“antifungals that show efficacy against C. albicans are likely to show efficacy
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`against dermatophytes”).
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`5.
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`In Ex. 2207 at 699:21-25, Dr. Murthy testified that “in most cases, if
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`you are sure that it [i.e., a compound] is active against C. albicans and if you know
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`the MIC value, that’s predictable of antifungal activity against dermatophytes.” At
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`710:16-711:14, Dr. Murthy testified that a POSA would have a reasonable
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`expectation of success based on Austin alone in part because “antifungal drugs that
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`are effective against C. albicans are also effective against dermatophytes.” At
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`697:8-698:3, Dr. Murthy testified that he was aware of this alleged relationship
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`between yeast and dermatophyte activity before his first declaration, but did not
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`make an argument based on the relationship until his second declaration. This
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`testimony is relevant because this argument was not in the Petition and was
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`presented for the first time with Petitioner’s Reply. This testimony is also relevant
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`because Dr. Murthy previously testified that a POSA would have a reasonable
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`expectation that tavaborole would have activity against dermatophytes because
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`structurally similar compounds allegedly possessed activity against dermatophytes.
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`See Ex. 1008 ¶¶ 100-01 (extrapolating the activity of Brehove’s compounds to
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`tavaborole); id. at ¶¶ 132-33 (extrapolating the activity of Freeman’s compounds to
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`tavaborole).
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`3
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`IPR2015-01776
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`6.
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`In Ex. 2207 at 667:21-668:11, Dr. Murthy affirmed that a POSA
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`would only need to know a compound’s MIC value and molecular weight in order
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`to determine whether the compound would have sufficient nail penetration to
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`successfully treat onychomycosis. This testimony is relevant because this
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`argument and the evidence Petitioner used to support it (e.g., Mertin & Lippold,
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`Ex. 1065; Kobayashi, Ex. 1076) were not in the Petition, and were presented for
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`the first time with Petitioner’s Reply. This testimony is also relevant because Dr.
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`Murthy previously asserted that a POSA would predict tavaborole’s nail
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`penetration based on the known nail penetration of structurally similar compounds.
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`See Ex. 1008 ¶¶ 95 & 102 (predicting nail penetration for tavaborole based on a
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`comparison with Brehove’s compounds); id. at ¶ 134 (predicting nail penetration
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`for tavaborole based on a comparison with Freeman’s compounds).
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`7.
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`In Ex. 2207 at 670:1-7, Dr. Murthy testified that he knew about the
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`Mertin & Lippold reference (Ex. 1065) before his first declaration and “ever since
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`I started working on the nail penetration.” At 746:14-747:1, Dr. Murthy testified
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`that he knew about Kobayashi (Ex. 1076) for years before this proceeding began.
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`This testimony is relevant because these references are central to Petitioner’s new
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`argument that molecular weight predicts nail penetration, see Reply p. 18; Ex.
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`1044 ¶¶ 64 & 69–70; Ex. 2207 at 669:14-17, but they were not in the Petition and
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`were presented for the first time with Petitioner’s Reply.
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`4
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`IPR2015-01776
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`8.
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`In Ex. 2207 at 677:1-23, Dr. Murthy testified that a POSA would not
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`be concerned about the toxicity of a topical drug, whether boron-containing or not,
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`because “the amount of drug that penetrates -- that gets into systemic circulation
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`would be negligible.” At 696:4-11, Dr. Murthy affirmed that toxicity concerns
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`would play no role in a POSA’s evaluation of potential molecules to treat
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`onychomycosis, testifying “a POSA would not be concerned about the toxicity.”
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`This testimony is relevant because this argument was not in the Petition and was
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`presented for the first time with Petitioner’s Reply. This testimony is also relevant
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`because Dr. Murthy previously testified that a POSA would take multiple steps to
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`address potential toxicity concerns. See Ex. 1008 ¶ 103.
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`9.
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`In Ex. 2207 at 673:17-20, Dr. Murthy testified that keratin binding “is
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`one of the factors that influence permeation of molecules.” At 674:14-18, Dr.
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`Murthy testified that “[m]olecules differ in their affinity towards keratin.” At
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`674:19-25, Dr. Murthy testified that “unless you do the practical experiment, you
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`will not know the extent of affinity of a molecule to keratin.” At 675:1-3, Dr.
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`Murthy stated that there was no data available in 2005 about tavaborole’s affinity
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`to keratin. This testimony is relevant because Dr. Murthy previously asserted that
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`“based on the disclosure of Austin alone, which identifies the low-molecular
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`weight compound tavaborole as preferred in the Abstract, a POSITA would have a
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`5
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`IPR2015-01776
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`reasonable expectation of successfully delivering tavaborole through the nail
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`plate.” See Ex. 1044 ¶ 81.
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`10.
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`In Ex. 2207 at 675:11-676:1, Dr. Murthy testified that a compound’s
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`solubility is a factor that influences nail penetration. At 731:9-22, Dr. Murthy
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`similarly testified that Mertin & Lippold teaches that the efficacy coefficient for a
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`topical drug is proportional to the compound’s maximum flux, which is itself
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`proportional to the solubility of the compound. At 733:2-13, Dr. Murthy testified
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`that he does not know if tavaborole’s water solubility was known in 2005, and that
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`his declaration does not provide tavaborole’s water solubility. This testimony is
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`relevant because Dr. Murthy previously asserted that “based on the disclosure of
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`Austin alone, which identifies the low-molecular weight compound tavaborole as
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`preferred in the Abstract, a POSITA would have a reasonable expectation of
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`successfully delivering tavaborole through the nail plate.” See Ex. 1044 ¶ 81.
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`11.
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`In Ex. 2207 at 741:1-742:12, Dr. Murthy testified that the four
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`compounds in Mertin & Lippold that possessed the highest water solubilities were
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`the same four compounds that had the highest efficacy coefficients against both
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`dermatophytes and yeasts. This testimony is relevant because it shows that an
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`antifungal compound must be reasonably water soluble in order to be efficacious,
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`and also because Dr. Murthy asserted in his Reply Declaration that “based on the
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`disclosure of Austin alone, which identifies tavaborole as having the lowest MIC
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`6
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`IPR2015-01776
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`tested against C. albicans, a POSITA would have a reasonable expectation of
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`successfully treating onychomycosis with tavaborole.” See Ex. 1044 ¶ 93.
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`12.
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`In Ex. 2207 at 678:11-684:24, Dr. Murthy testified that a POSA
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`would only need to know a compound’s MIC value against C. albicans and its
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`molecular weight in order to determine whether there is a reasonable expectation
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`of successfully treating onychomycosis, but Dr. Murthy was unable to explain how
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`variations in MIC or molecular weight would affect his analysis. This testimony is
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`relevant to the scientific support, or lack thereof, for Dr. Murthy’s proposed two-
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`variable prediction method.
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`13.
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`In Ex. 2207 at 719:4-8, Dr. Murthy testified that Ex. 2157, which was
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`published in 2006, was not available to a POSA in 2005. At 719:20-721:1, Dr.
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`Murthy also testified that Ex. 2157 cites Austin for a “synthetic procedure”
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`unrelated to tavaborole. This testimony is relevant because Dr. Murthy later
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`asserted that Austin is analogous art because, in part, Ex. 2157 shows that the
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`inventors of the ’621 Patent were aware of the Austin reference. See Ex. 2207 at
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`721:2-6; Ex. 1044 ¶ 43.
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`14.
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`In Ex. 2207 at 740:7-25, Dr. Murthy affirmed that tavaborole’s
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`antifungal activity against C. albicans was “middle of the pack” compared to the
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`other antimycotics tested in Table 2 of Mertin & Lippold. This testimony is
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`7
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`relevant because Petitioner’s Reply Brief asserted that Austin discloses “potent
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`antifungal activity.” Reply p. 2.
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`IPR2015-01776
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`Date: September 27, 2016
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`Respectfully submitted,
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`
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`Andrea G.Reistér
`RegistrationNo. 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 Motion for Observations Regarding
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`the Cross-Examination Testimony of S. Narasimha Murthy, Ph.D. was served by
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`electronic mail, by agreementof the parties, on the following counsel of record for
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`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: September 27, 2016
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`(tnt Jag si
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`Andrea G.Reister, Esq.
`Reg. No.: 36,253
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`
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