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`Paper No. ___
`Filed: December 22, 2017
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`ACRUX DDS PTY LTD., ACRUX LIMITED, and
`ARGENTUM PHARMACEUTICALS LLC,
`Petitioners,
`
`v.
`
`KAKEN PHARMACEUTICAL CO., LTD. and
`VALEANT PHARMACEUTICALS INTERNATIONAL, INC.,
`Patent Owner.
`
`
`
`Case: IPR2017-001901
`U.S. Patent No. 7,214,506
`
`
`
`PATENT OWNER’S MOTION FOR OBSERVATIONS ON THE
`CROSS-EXAMINATION OF JEFFREY M. WEINBERG, M.D.
`
`
`1 Case IPR2017-01429 has been joined with the instant proceeding.
`
`
`
`
`
`Case: IPR2017-00190
`U.S. Patent No. 7,214,506
`
`Pursuant to the Scheduling Order (Paper No. 13), Patent Owner submits this
`
`Motion for Observations on the Cross-Examination of Jeffrey M. Weinberg, M.D.
`
`Observation #1: In Exhibit 2118 at 9:20-10:14 and 14:5-15:8, Dr. Weinberg
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`admits that in preparing for this case he did not familiarize himself with the
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`biochemistry and chemical structures of various classes of antifungal compounds,
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`nor could he explain the type and arrangement of keratin in different tissue
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`structures. This testimony is relevant to his discussion of various chemical
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`structures and their relationship to keratin in his declaration, Ex. 1510, at
`
`paragraphs 32-34, 37, 42, 43, and 47. It speaks to the weight and credibility of Dr.
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`Weinberg’s conclusions regarding the predictability of the pharmacokinetic
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`properties of various antifungal compounds because it raises concerns about Dr.
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`Weinberg’s ability to opine on these properties and the possibility that he may have
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`been speculating on them.
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`Observation #2: In Exhibit 2118 at 181:14-191:21, Dr. Weinberg testified
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`that he did not review the prosecution history, priority application, or other art in
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`concluding what one of skill would have understood when the ’506 patent referred
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`to treating a subject having onychomycosis. This testimony is relevant to
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`statements in Exhibit 1510, e.g., paragraphs 23-30 discussing the meaning of this
`
`phrase, indicating first that it was hard to treat but later that any level of treatment
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`was adequate. The testimony speaks to the weight and credibility the Board should
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`1
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`Case: IPR2017-00190
`U.S. Patent No. 7,214,506
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`afford to Dr. Weinberg’s conclusions because they may be contradictory and it
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`suggests Dr. Weinberg may not have applied the correct legal standard.
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`Observation #3: In Exhibit 2118 at 15:12-16:2, 57:16-59:4, 113:1-15,
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`115:6-17, Dr. Weinberg testified that he did not know what factor pharmaceutical
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`companies considered in developing topical antifungal medications but Ogura or
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`the Kaken Abstracts would motivate a POSA to “explore” or “investigate”
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`efinaconazole. This testimony is relevant to Exhibit 1510 at paragraphs 31-45,
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`where Dr. Weinberg describes whether there would have been a motivation to
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`combine the cited references with an expectation of success. It speaks to the
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`weight of Dr. Weinberg’s opinions that a person of skill would reasonably combine
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`the art cited in his declaration with an expectation of success and whether he
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`possibly applied an incorrect legal standard as the basis for his opinions.
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`Observation #4: In Exhibit 2118 at 33:21-34:20, 36:4-22, 38:15-22, and
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`60:14-62:11, Dr. Weinberg states that he did not draft any of his declaration
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`himself, nor did he independently assess art in the relevant field for the ’506
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`patent. This testimony is relevant to the entirety of Exhibit 1510, particularly to
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`the discussion of what Dr. Weinberg did to prepare his declaration in paragraphs 1
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`and 13-22. It speaks to the weight and credibility of Dr. Weinberg’s conclusions
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`throughout his declaration, as they may have not been based on an investigation of
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`2
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`Case: IPR2017-00190
`U.S. Patent No. 7,214,506
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`the underlying facts, and it indicates that he may have applied an incorrect legal
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`standard as the basis for his opinions.
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`Observation #5: In Exhibit 2118 at 38:5-14 and 41:15-42:12, Dr. Weinberg
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`states that in July 2000, which he testified is the date he used for the priority of the
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`’506 patent, he had just finished his residency and that he did not then have twenty
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`years of experience. This testimony is relevant to Exhibit 1510, and particularly to
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`paragraph 22 of that exhibit, addressing Dr. Weinberg’s ability to testify to the skill
`
`in the art at the time of invention. It speaks to the weight and credibility the Board
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`should afford to Dr. Weinberg’s opinions because it raises concerns about his
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`ability to address what those skilled in the art would know and think at the time of
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`the claimed invention.
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`Observation #6: In Exhibit 2118 at 42:21-44:11, Dr. Weinberg states that
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`onychomycosis was difficult to treat in 1999 without an oral therapy and that
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`effective topical agents had been challenging to identify. He also testified at
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`259:14-262:8 that he prescribes Jublia for onychomycosis and the table in his
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`declaration shows that efinaconazole is almost twice as effective as ciclopirox.
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`This testimony is relevant to the discussion in Exhibit 1510 at paragraph 23, 25,
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`28, and 63-75 of whether onychomycosis was difficult to treat, particularly with
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`topical agents, and whether Jublia offered a significant improvement in topical
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`treatment. It speaks to the weight and credibility of Dr. Weinberg’s conclusions on
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`3
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`Case: IPR2017-00190
`U.S. Patent No. 7,214,506
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`these topics because it was unclear what he believed one of skill in the art would
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`have understood about the properties needed in an effective topical treatment and
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`whether Jublia was a revolutionary breakthrough based on those properties.
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`Observation #7: In Exhibit 2118 at 43:1-44:13 and 50:10-52:2, Dr.
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`Weinberg states that onychomycosis had low cure rates in 1999 but identifying
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`reasons for the low cures rates is “a bit speculative.” This testimony is relevant to
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`Exhibit 1510 at paragraph 23, 24, 28, 30, and 31-45, where Dr. Weinberg discusses
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`whether a skilled artisan would reasonably expect efinaconazole to work based on
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`the discussion of other agents in the cited art. It speaks to the weight and
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`credibility of Dr. Weinberg’s conclusions that one of skill in the art would have
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`had a reasonable expectation of success using efinaconazole in a topical treatment
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`of onychomycosis because it suggests Dr. Weinberg was speculating about the
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`predictability of using the drugs he cites in his declaration.
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`Observation #8: In Exhibit 2118 at 44:12-45:3, 140:20-142:2, Dr. Weinberg
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`states that tinea pedis, tinea captitis, and tinea barbae are each different infections
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`characterized by different tissue locations. This testimony is relevant to Exhibit
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`1510 at 37-45 and 58-62, where Dr. Weinberg indicates that testing of
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`efinaconazole in other tissues would lead the skilled artisan to expect success using
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`the drug on nail and that its efficacy was allegedly know in the art. It speaks to the
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`weight and credibility of Dr. Weinberg’s conclusions about what the skilled artisan
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`4
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`Case: IPR2017-00190
`U.S. Patent No. 7,214,506
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`would extrapolate from other skin structures to conclude about efinaconazole’s
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`efficacy in nail.
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`Observation #9: In Exhibit 2118 at 53:3-54:6, Dr. Weinberg states that “a
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`lot of patients” now prefer topical treatment and that he prescribes either generic
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`ciclopirox or Jublia in the clinic. This testimony is relevant to Dr. Weinberg’s
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`discussion of secondary considerations in paragraphs 63-75 of Exhibit 1510,
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`specifically whether Jublia offered patients an improved treatment option that was
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`surprisingly better or superior in kind to the existing alternatives. It speaks to the
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`weight and credibility of Dr. Weinberg’s conclusions about those secondary
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`considerations as they appear to be inconsistent with his clinical practice.
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`Observation #10: In Exhibit 2118 at 54:7-56:16, Dr. Weinberg explains that
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`the treatments that he prescribes for tinea pedis are different from the treatments
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`that he prescribes for onychomycosis. This testimony is relevant to Ex. 1510 at
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`paragraphs 37-45 and 58 where Dr. Weinberg suggests efinacoinzaole’s beneficial
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`properties for treating onychomycosis could be predicted from its efficacy in
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`treating tinea pedis. It speaks to the weight and credibility of Dr. Weinberg’s
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`conclusions about a reasonable expectation of success because it may have been
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`speculation without evidence and it may have been contradicted by Dr. Weinberg’s
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`clinical practice.
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`5
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`Case: IPR2017-00190
`U.S. Patent No. 7,214,506
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`Observation #11: In Exhibit 2118 at 57:16-59:16, Dr. Weinberg states that
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`he does not know what factors pharmaceutical companies considered when
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`developing topical antifungal medications or whether there were other antifungal
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`compounds that had properties comparable to or superior to efinaconazole in the
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`literature at the time of invention but a person of ordinary skill would have had
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`unidentified additional information regarding efinaconazole available to them.
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`This testimony is relevant to Dr. Weinberg’s discussion in Exhibit 1510 at 32-45 of
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`the properties he thought a skilled artisan would recognize in efinaconazole that
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`would lead them to expect success topically treating onychomycosis. It speaks to
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`the weight and credibility of Dr. Weinberg’s conclusion that the properties of
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`efinaconazole were recognizable in the art at the time of invention because he
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`could not identify any such properties when asked.
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`Observation #12: In Exhibit 2118 at 68:1-73:1, Dr. Weinberg discussed
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`Exhibit 1504 and admitted that he does not know the standard for the FDA’s
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`priority review or how that compared with the procedures for efinaconazole’s final
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`NDA review. This testimony is relevant to the discussion of Ex. 1504 in Exhibit
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`1510 at paragraphs 25, 58, 68, and 72. It speaks to the credibility of Dr.
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`Weinberg’s reliance on statements from the FDA priority review for efinaconazole
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`because he did not know the basis for the FDA’s conclusions or the underlying
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`facts for that conclusion.
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`6
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`Case: IPR2017-00190
`U.S. Patent No. 7,214,506
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`Observation #13: In Exhibit 2118 at 195:9-197:14, see also id. at 73:5-75:6,
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`and 276:19-277:6, Dr. Weinberg stated that he does not have any experience using
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`topical amorolfine, tioconazole or oral fluconazole to treat onychomycosis, and
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`none of them are approved in the United States. This testimony is relevant to his
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`discussion of whether those alternate drugs provide guidance about the expected
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`efficacy of efinaconazole in Ex. 1510, e.g., at paragraphs 25, 31-45, and 59. It
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`speaks to the weight and credibility of Dr. Weinberg’s conclusions about the
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`ability to extrapolate from treatment efficacy using other drugs when those drugs
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`may not have been effective.
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`Observation #14: In Exhibit 2118 at 75:7-78:20, Dr. Weinberg testifies that
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`he does not have any scientific evidence comparing oral terbinafine to topical
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`efinaconazole. This testimony is relevant to Exhibit 1510 at paragraph 25, 59, and
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`63-75 discussing oral terbinafine as the gold standard for treating onychomycosis
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`and comparing it to Jublia’s efficacy. It speaks to the weight of Dr. Weinberg’s
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`conclusions comparing Jublia to the competitor treatments as it suggests this was
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`not supported by underlying data.
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`Observation #15: In Exhibit 2118 at 103:16-108:14, 109:22-112:22, and
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`117:15-118:5, Dr. Weinberg testified that the ’367 patent only discloses
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`tioconazole and does not disclose any efficacy data that he would need before
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`relying on the patent’s statement about tioconazole’s efficacy, meaning he could
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`7
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`Case: IPR2017-00190
`U.S. Patent No. 7,214,506
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`only speculate. This testimony is relevant to the discussion of the ’367 patent in
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`Exhibit 1510 at paragraphs 31-33. It speaks to the weight and credibility of Dr.
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`Weinberg’s opinions addressing the reasonable expectation of success based on
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`combining references with the ’367 patent because it suggests Dr. Weinberg was
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`evaluating those combinations without having the data he himself suggested would
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`be necessary to the evaluation.
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`Observation #16: In Exhibit 2118 at 56:17-58:19, 134:8-135:11, 252:8-
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`253:5, 258:18-259:9, see also id. at 58:20-60:12, 102:16-103:10, 115:19-118:5,
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`and 229:15-20, Dr. Weinberg testified that he has not been involved in drug
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`development and does not know what factors a person of ordinary skill seeking to
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`develop a topical treatment for onychomycosis would have considered. But he
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`also testified at 267:18-271:8 that he agreed with the properties of an effective
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`topical agent listed in Ex. 2075, which include being keratinophilic. This
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`testimony is relevant to Exhibit 1510 at paragraphs 1-12, 18, and 32-45,
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`particularly Dr. Weinberg’s discussion of how his background in treating
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`onychomycosis is relevant to evaluating the claims of the ’506 patent and whether
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`the skilled artisan would have been motivated to combine the cited art because of
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`efinaconazole’s properties in the presence of keratin. It speaks to the weight and
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`credibility of Dr. Weinberg’s explanation of what the skilled artisan knew about
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`drug interactions with keratin, or whether those properties would have motivated a
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`8
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`Case: IPR2017-00190
`U.S. Patent No. 7,214,506
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`person of ordinary skill to use efinaconazole in a topical treatment for
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`onychomycosis, because Dr. Weinberg could not identify the relevant properties.
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`Observation #17: In Exhibit 2118 at 113:16-115:4, Dr. Weinberg testified
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`that he does not know whether the keratin affinity of tioconazole was known as of
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`the ’506 patent’s critical date or if it is known today. This is relevant to Exhibit
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`1510 at paragraphs 31-33, specifically the discussion of whether a person of
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`ordinary skill in the art would have substituted efinaconazole for tioconazole in the
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`’367 patent. The testimony raises concerns about the evidentiary support for Dr.
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`Weinberg’s conclusion that a skilled artisan would be motivated to select
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`efinaconazole from the art due to its low keratin affinity.
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`Observation #18: In Exhibit 2118 at 161:5-13 and 172:11-22, Dr. Weinberg
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`testified that it would be “too speculative” to say whether a POSA as of July 2000
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`would have viewed adsorption to keratin as a favorable property, as he is not aware
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`of any studies prior to July 2000 evaluating the effect of that adsorption other than
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`Ogura (Ex. 1012) and the Kaken Abstracts (Ex. 1015). But he also testified (id. at
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`199:15-200:14) that itraconazole had strong affinity for keratinized tissues,
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`resulting in high concentrations of the drug in nail and contributing to its
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`effectiveness in the treatment of onychomycosis. This testimony is relevant to the
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`discussion of keratin affinity in Exhibit 1510 at paragraphs 32-45. It speaks to the
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`weight and credibility of Dr. Weinberg’s conclusions about the recognized role of
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`9
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`Case: IPR2017-00190
`U.S. Patent No. 7,214,506
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`keratin affinity at the time of the invention because his testimony appears
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`inconsistent with that conclusion.
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`Observation #19: In Exhibit 2118 at 130:6-10, Dr. Weinberg states that “the
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`horny layer” is the stratum corneum of skin. This testimony is relevant to Exhibit
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`1510 at paragraph 31-45 discussing what the skilled artisan would conclude based
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`on efinaconazole’s retention in the horny layer. It speaks to the weight and
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`credibility of Dr. Weinberg’s conclusions because they focus on efinaconazole’s
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`properties in skin rather than nail.
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`Observation #20: In Exhibit 2118 at 133:4-10 and 135:1-11, Dr. Weinberg
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`states that he first heard of efinaconazole within the last ten years. This testimony
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`is relevant to Exhibit 1510 at 58-62 where Dr. Weinberg states that a POSA would
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`have known of efinaconazole’s efficacy and been motivated to select it from other
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`available antifungals in the art. It speaks to the weight of Dr. Weinberg’s opinions
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`that the unique properties of efinaconazole were recognized as of the ’506 patent’s
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`critical date because he himself was not aware of the drug until later.
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`Observation #21: In Exhibit 2118 at 135:13-137:11, Dr. Weinberg testified
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`that the clotrimazole mentioned in Ogura (Ex. 1012) has been used for tinea pedis
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`with low efficacy but he does not know if it had ever been used for
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`onychomycosis. This testimony is relevant to Exhibit 1510 at paragraph 42 where
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`Dr. Weinberg stated that clotrimazole had been used for onychomycosis treatment.
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`10
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`Case: IPR2017-00190
`U.S. Patent No. 7,214,506
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`It speaks to the weight and credibility of Dr. Weinberg’s conclusions that the
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`antifungal compounds studied in Ogura would have reasonably led the skilled
`
`artisan to consider using topical efinaconazole in treating onychomycosis because
`
`those conclusions appear to be inconsistent with his testimony.
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`Observation #22: In Exhibit 2118 at 142:15-143:16, 156:4-157:17, Dr.
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`Weinberg states that he does not know if neticonazole, lanoconazole, and
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`butenafine are used for any fungal treatment. This testimony is relevant to the
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`discussion of these comparator agents in Exhibit 1510 at paragraphs 37-45 and 72.
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`It speaks to the weight and credibility of Dr. Weinberg’s conclusions that the data
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`in the Kaken Abstracts and Ogura provide guidance to the skilled artisan on the
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`effectiveness of efinaconazole because the testimony raises concerns regarding the
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`evidentiary support for Dr. Weinberg’s conclusions.
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`Observation #23: In Exhibit 2118 at 160:14-161:4, Dr. Weinberg states that
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`Ogura (Ex. 1012) does not study an infection of the hair. This testimony is
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`relevant to Exhibit 1510 at paragraphs 37, 38, and 56 comparing nail, hair, and
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`skin. It speaks to the weight and credibility of Dr. Weinberg’s conclusions about
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`what Ogura’s testing of efinaconazole would indicate to the skilled artisan about its
`
`efficacy in treating onychomycosis because the testimony suggests Ogura did not
`
`provide relevant data.
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`11
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`Case: IPR2017-00190
`U.S. Patent No. 7,214,506
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`Observation #24: In Exhibit 2118 at 192:8-15, 202:14-205:6, Dr. Weinberg
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`states that Dr. Hay is well-known and well-respected and he had seen a book
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`chapter he edited on onychomycosis (Ex. 2008). This testimony is relevant to Dr.
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`Weinberg’s discussion of the Hay reference (Ex. 1014) in Exhibit 1510 at
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`paragraphs 34-36 and 53. It speaks to the weight of Dr. Weinberg’s conclusions
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`about the efficacy reported in Ex. 1014 for tioconazole when Dr. Hay himself cites
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`the article in a report (Ex. 2008) indicating that it is not effective.
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`Observation #25: In Exhibit 2118 at 215:13-218:4 and 223:6- 230:19, Dr.
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`Weinberg states that the difference between “nail” and “nail unit” is a matter of
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`semantics, and one of his publications says “onychomycosis, by definition is a
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`mycotic infection of the keratinized tissue of the nail plate.” This testimony is
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`relevant to Exhibit 1510 at paragraphs 46-57 where Dr. Weinberg suggests that Dr.
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`Elewski used a narrower definition for “nail” by referring to the “nail unit.” It
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`speaks to the weight and credibility of Dr. Weinberg’s assessment of Dr.
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`Elewski’s opinions and whether he would draw a scientific distinction between nail
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`and nail plate outside the context of this proceeding.
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`Observation #26: In Exhibit 2118 at 242:1-21, Dr. Weinberg states that he
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`does not know when terbinafine hydrochloride cream or Lamisil AT gel were
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`approved. This testimony is relevant to Exhibit 1510 at paragraph 57 and footnote
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`2 discussing available prior art products, including terbinafine hydrochloride cream
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`12
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`Case: IPR2017-00190
`U.S. Patent No. 7,214,506
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`or Lamisil AT gel. The testimony speaks to the weight and credibility of Dr.
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`Weinberg’s conclusions about terbinafine hydrochloride cream or Lamisil AT gel
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`because it suggests speculation on whether those products were available prior to
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`the ’506 patent’s critical date.
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`Observation #27: In Exhibit 2118 at 249:16-256:19, Dr. Weinberg states
`
`that it is a difficult for him to comment on references such as Ex. 2057 discussing
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`properties such as keratin affinity and molecular weight and their roles in drug
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`development, given his medical background. This testimony is relevant to Dr.
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`Weinberg’s discussion in Exhibit 1510, e.g., at paragraphs 32-35, 37, 42, and 47,
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`explaining what one of skill in the art would have thought about efinaconazole’s
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`properties and what that indicated for its use in treating onychomycosis. It speaks
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`to the weight and credibility of Dr. Weinberg’s conclusions because he may lack
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`the relevant background to analyze the cited art.
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`Observation #28: In Exhibit 2118 at 262:9-267:13, Dr. Weinberg states that,
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`according to Jublia’s label (Ex. 2043), it is indicated for topical treatment of
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`onychomycosis of the toenails due to Trichophyton rubrum and Trichophyton
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`mentagrophtyes. This testimony is relevant to Exhibit 1510 at paragraph 69 where
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`Dr. Weinberg states that Jublia is only indicated for patients having “mild to
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`moderate cases” of onychomycosis, which is not consistent with the label. The
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`testimony speaks to the weight and credibility of Dr. Weinberg’s conclusions
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`13
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`Case: IPR2017-00190
`U.S. Patent No. 7,214,506
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`regarding Jublia because it raises concerns regarding the evidentiary support for his
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`conclusions.
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`Respectfully submitted,
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`Dated: December 22, 2017
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`By: /John D. Livingstone/
`John D. Livingstone, Reg. No. 59, 613
`FINNEGAN, HENDERSON, FARABOW,
`
`GARRETT & DUNNER, LLP
`901 New York Avenue, NW
`Washington, DC 20001-4413
`(202) 408-4000
`
`Counsel for Patent Owner in
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`IPR2017-00190
`
`14
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`
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`Case: IPR2017-00190
`U.S. Patent No. 7,214,506
`
`CERTIFICATE OF SERVICE
`
`The undersigned certifies that a copy of the foregoing Patent Owner’s
`
`Motion for Observations on the Cross-Examination of Jeffrey M. Weinberg,
`
`M.D. was served electronically via email on December 22, 2017, in its entirety on
`
`the following:
`
`E. Anthony Figg
`Aydin H. Harston
`Lisa N. Phillips
`Rothwell, Figg, Ernst & Manbeck, P.C.
`607 14th Street, N.W., Suite 800
`Washington, DC 20005
`efigg@rothwellfigg.com
`aharston@rothwellfigg.com
`lphillips@rothwellfigg.com
`litigationparalegals@rothwellfigg.com
`
`Teresa Stanek Rea
`Shannon M. Lentz
`Crowell & Moring LLP
`Intellectual Property Group
`1001 Pennsylvania Ave., NW
`Washington, DC 20004-2595
`trea@crowell.com
`slentz@crowell.com
`
`Tyler C. Liu
`Argentum Pharmaceuticals, LLC
`tliu@agpharm.com
`
`
`
`
`
`By: /John D. Livingstone/
`John D. Livingstone
`Reg. No. 59,613
`
`
`
`
`
`
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