Paper __
`Served: December 6, 2017
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_______________
`
`ACRUX DDS PTY LTD., ACRUX LIMITED,
`ARGENTUM PHARMACEUTICALS LLC,
`Petitioners,
`
`v.
`
`KAKEN PHARMACEUTICAL CO., LTD. and
`VALEANT PHARMACEUTICALS INTERNATIONAL, INC.,
`Patent Owner.
`_______________
`
`Case IPR2017-001901
`Patent 7,214,506 B2
`_______________
`
`
`PETITIONERS’ RESPONSE TO PATENT OWNER’S
`MOTION TO STRIKE
`
`
`
`
`
`
`
`
`
`
`
`
`
`1 Case IPR2017-01429 has been joined with the instant proceeding.
`
`
`
`
`
`
`Served: December 6, 2017
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_______________
`
`ACRUX DDS PTY LTD., ACRUX LIMITED,
`ARGENTUM PHARMACEUTICALS LLC,
`Petitioners,
`
`v.
`
`KAKEN PHARMACEUTICAL CO., LTD. and
`VALEANT PHARMACEUTICALS INTERNATIONAL, INC.,
`Patent Owner.
`_______________
`
`Case IPR2017-001901
`Patent 7,214,506 B2
`_______________
`
`
`PETITIONERS’ RESPONSE TO PATENT OWNER’S
`MOTION TO STRIKE
`
`
`
`
`
`
`
`
`
`
`
`
`
`1 Case IPR2017-01429 has been joined with the instant proceeding.
`
`
`
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`
`
`TABLE OF CONTENTS
`
`Case IPR2017-00190
`Patent 7,214,506 B2
`
`
`I.
`
`II.
`
`INTRODUCTION ........................................................................................... 1
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`PETITIONERS’ EXHIBITS ARE APPROPRIATE REBUTTAL AND
`THE REPLY INTRODUCED NO NEW ARGUMENTS .............................. 3
`
`A.
`
`B.
`
`C.
`
`Petitioners’ Reply Appropriately Cites Expert Testimony ................... 5
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`Petitioners’ Exhibits Are Appropriate ................................................. 11
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`Petitioners’ Reply Raises No “New Legal Theory” ............................ 14
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`III. CONCLUSION .............................................................................................. 15
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`
`
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`
`
`
`ii
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`
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`TABLE OF AUTHORITIES
`
`Case IPR2017-00190
`Patent 7,214,506 B2
`
`
`Cases
`Apple, Inc. v. Evolved Wireless LLC,
`IPR2016-01347, Paper 11 (PTAB Apr. 17, 2017) .............................................4, 9
`
`Arctic Cat Inc., v. Polaris Indus. Inc.,
`IPR2015-01783, Paper 49 (PTAB Jan. 30, 2017) ................................................ 11
`
`Ariad Pharms., Inc. v. Eli Lilly & Co.,
`598 F.3d 1336 (Fed. Cir. 2010) ............................................................................ 15
`
`Belden Inc. v. Berk-Tek LLC,
`805 F.3d 1064 (Fed. Cir. 2015) ..........................................................................3, 5
`
`Berk-Tek LLC v. Belden Techs. Inc.,
`IPR2013-00057, Paper 29 (PTAB Sept. 10, 2013) ................................................. 3
`
`Elec. Arts Inc. v. Terminal Reality, Inc.,
`IPR2016-00929, IPR2016-00930, Paper 50 (PTAB Oct. 19, 2017) ...................... 7
`
`Genzyme Therapeutic Prods. Ltd. v. Biomarin Pharm. Inc.,
`825 F.3d 1360 (Fed. Cir. 2016) .............................................................................. 3
`
`Hughes Network Sys., LLC v. Cal. Inst. of Tech.,
`IPR2015-00059, Paper 42 (PTAB Apr. 21, 2016) ........................................ 10, 11
`
`Kinetic Techs., Inc. v. Skyworks Solutions, Inc.,
`IPR2014-00529, Paper 8 (PTAB Sept. 23, 2014) ................................................... 9
`
`Nichia Corp. v. Emcore Corp.,
`IPR2012-00005, Paper 68 (PTAB Feb. 11, 2014) .................................................. 6
`
`NuVasive, Inc.,
`841 F.3d 966 (Fed. Cir. 2016) ................................................................................ 4
`
`Sony Computer Entm’t Am. LLC v. Game Controller Tech. LLC,
`IPR2013-00634, Paper 32 (PTAB Apr. 14, 2015) ............................................... 11
`
`Sumitomo Elec. Indus., Ltd. v. United Techs. Corp.,
`IPR2017-00966, Paper 7 (PTAB Sept. 13, 2017) ............................................ 4, 12
`
`
`
`iii
`
`
`
`TV Mgmt., Inc. v. Perdiemco LLC,
`IPR2016-01278, Paper 41 (PTAB July 26, 2017) ................................................ 10
`
`Case IPR2017-00190
`Patent 7,214,506 B2
`
`
`Rules
`
`37 C.F.R § 42.6 .......................................................................................................... 4
`
`37 C.F.R. § 42.23 ...................................................................................... 3, 9, 10, 15
`
`37 C.F.R. § 42.65 ................................................................................................ 4, 13
`
`
`
`
`
`
`
`iv
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`
`
`
`I.
`
`INTRODUCTION
`
`Cutting through the hyperbole and mischaracterizations, Patent Owner’s
`
`(“PO”) Motion to Strike is reduced to a complaint that Petitioners have responded
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`to the large number of conclusory, unsupported, and inaccurate arguments in the
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`PO Response (“POR”) and accompanying lengthy expert declarations with
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`comprehensive and well-documented rebuttal. PO accuses Petitioners of
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`improperly incorporating portions of their expert declarations and exhibits into
`
`their Reply by reference. Not true. Petitioners’ expert declarations contain expert
`
`testimony supported by documentary evidence and are directly responsive to
`
`arguments raised by PO’s experts and in the POR. Rebuttal expert testimony
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`belongs in the sworn declarations, not the Reply, and the Reply properly cites to
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`such testimony as evidentiary support for the arguments presented.
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`PO exaggerates alleged difficulties in linking Petitioners’ expert testimony
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`and documentary evidence to the Reply arguments. PO accuses Petitioners of
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`“block citing” the declarations by properly referring to discrete sections,
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`subsections or groups of paragraphs arranged by topic and responsive to assertions
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`made by PO’s experts. PO’s complaints are belied by the fact that the POR does
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`the same. Contrary to PO’s accusations, the pertinence of Petitioners’ expert
`
`testimony to the Reply arguments is readily apparent. And while both parties’
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`
`
`
`
`
`
`expert declarations contain information that is not explicitly cited in the pleadings
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`Case IPR2017-00190
`Patent 7,214,506 B2
`
`
`regarding qualifications, claim construction, and background information, the
`
`pertinence of that information is readily apparent. To the extent that both parties’
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`expert declarations contain information not expressly cited, the Board is, of course,
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`free to ascribe whatever weight it deems appropriate.
`
`PO claims that Petitioners used an “evidence overload … to raise a new
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`legal theory.” But when the basis for that claim is finally revealed, it is clear that it
`
`is a single meritless argument that the Board should not consider whether PO’s
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`own two blocking patents negate its claimed secondary considerations. Petitioners’
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`rebuttal to arguments presented for the first time in the POR is manifestly proper.
`
`Petitioners’ rebuttal evidence about which PO complains includes (1)
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`publications by PO’s expert, Dr. Elewski, that contradict her declaration testimony
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`(Exs. 1512 & 1518); (2) Petitioners’ experts’ rebuttal of new issues introduced by
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`Dr. Elewski’s poorly supported declaration (Exs. 1509-1511); and (3) evidence of
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`Valeant’s dubious business practices, huge advertising campaign, and pricing
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`concessions that generated the bloated gross sales figures on which PO relies to
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`claim “commercial success” (Exs. 1515-1517, 1523-1660). Further, major portions
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`of Petitioners’ expert declarations quote and rely on the numerous admissions by
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`Dr. Elewski during cross-examination, which PO might like to suppress, but
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`invariably are part of the record. See Ex. 1509 (Walters): ¶¶ 7, 9-14, 17, 19, 21-22,
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`
`
`2
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`
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`28, 35, 37-39, 41, 44, 51, 54, 59, 69, 86, 105, 109, 112, 115, 125, 132; Ex. 1510
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`Case IPR2017-00190
`Patent 7,214,506 B2
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`(Weinberg): ¶¶ 24, 28-30, 32-33, 35, 46, 49, 50, 52-53, 57, 59, 63, 73.
`
`II.
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`PETITIONERS’ EXHIBITS ARE APPROPRIATE REBUTTAL AND
`THE REPLY INTRODUCED NO NEW ARGUMENTS
`
`Petitioners’ Reply and accompanying expert declarations are proper under
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`37 C.F.R. § 42.23(b), because they only respond to the multitude of new issues
`
`raised by the POR and PO’s experts. PO misstates the law in arguing that
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`Petitioners’ evidence is improper if it “could have been presented earlier.” Mot. at
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`3. “[I]t is not the test for determining appropriateness of a Reply merely to see
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`whether information was previously available to [Petitioner] and could have been
`
`submitted with its Petition.” Berk-Tek, LLC v. Belden Techs. Inc., IPR2013-00057,
`
`Paper 29 at 2 (PTAB Sept. 10, 2013) (emphasis added), aff’d Belden Inc. v. Berk-
`
`Tek LLC, 805 F.3d 1064, 1078-79 (Fed. Cir. 2015). The proper inquiry is whether
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`the Reply responds to arguments in the POR. Belden, 805 F.3d at 1078-79.
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`Petitioners’ submission of new expert declarations and exhibits in response
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`to PO’s new arguments in the POR is entirely appropriate. Id.; see Genzyme
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`Therapeutic Prods. Ltd. v. Biomarin Pharm. Inc., 825 F.3d 1360, 1367 (Fed. Cir.
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`2016) (“The purpose of the trial in an inter partes review proceeding is to give the
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`parties an opportunity to build a record by introducing evidence—not simply to
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`weigh evidence of which the Board is already aware.”). PO’s heavy reliance on
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`
`
`3
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`
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`NuVasive, Inc., 841 F.3d 966 (Fed. Cir. 2016) is misplaced. In that case, the Board
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`Case IPR2017-00190
`Patent 7,214,506 B2
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`relied on a new figure “as an essential part of its obviousness findings,” altering
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`grounds of rejection. Id. at 971. Here, the Reply declarations do not alter the basis
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`for invalidating PO’s claims and are only proper rebuttal to PO’s arguments.
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`Citation to expert declarations and exhibits does not constitute
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`“incorporation by reference” of those materials in contravention of the Board’s
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`word limits or 37 C.F.R § 42.6(a)(3). “Not every statement made by an expert need
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`be repeated in a brief to avoid incorporation by reference; otherwise, separate
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`expert declarations would be unnecessary.” Sumitomo Elec. Indus., Ltd. v. United
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`Techs. Corp., IPR2017-00966, Paper 7 at 11 (PTAB Sept. 13, 2017). Moreover,
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`the expert opinions on which Petitioners rely are scientific, medical, and economic
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`opinions—not lawyer argument—and thus properly belong in the declarations
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`rather than the Reply. Petitioners’ experts provide “adequate elaboration and
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`explanation” of scientific and economic arguments made in the Reply. Apple, Inc.
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`v. Evolved Wireless LLC, IPR2016-01347, Paper 11 at 4 (PTAB Apr. 17, 2017).
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`As required by 37 C.F.R. § 42.65(a), Petitioners’ experts “disclose the
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`underlying facts or data on which the opinion is based,” including proper citations
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`to exhibits evidencing those facts. It would be inappropriate and unhelpful to the
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`Board to strike those exhibits as PO now urges. PO should not be surprised that a
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`thorough and documented response takes more words than the conclusory and
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`
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`4
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`
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`unsupported opinions offered by PO’s experts. PO may now regret the conclusory
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`Case IPR2017-00190
`Patent 7,214,506 B2
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`and inaccurate nature of its expert declarations, but striking Petitioners’ thorough
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`rebuttal of that testimony would inappropriately reward those defects.
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`Petitioners’ Reply Appropriately Cites Expert Testimony
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`A.
`Ex. 1510 (Weinberg). Dr. Weinberg directly responds to misleading medical
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`arguments and claims of long-felt need and praise by dermatologists proffered by
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`Dr. Elewski. Ex. 1510 at ii (Table of Contents). A new expert may be introduced
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`with the Reply to respond to new issues raised by the POR. Belden, 805 F.3d 1078.
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`PO does not identify a single opinion in Dr. Weinberg’s declaration that is
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`not a direct response to Dr. Elewski or the POR. Instead, PO insinuates that Dr.
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`Weinberg’s declaration is intended to solve some concern about Dr. Walters. Not
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`so. PO’s attacks on Dr. Walters’ expertise are spurious.2 Dr. Weinberg’s
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`declaration is a proper rebuttal to medical opinions offered by Dr. Elewski—not a
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`response to PO’s baseless criticisms of Dr. Walters’ expertise.
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`2 Dr. Walters holds a Ph.D. and has over four decades of experience researching
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`and publishing peer-reviewed articles on human nail and antifungal therapies. Ex.
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`1509 ¶¶127-132. Moreover, Dr. Elewski admitted that treating physicians and
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`clinical researchers like her do not typically develop new therapies. Ex. 1508 at
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`21:15-22:18. Indeed, none of the named inventors on the ’506 patent are medical
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`doctors. Ex. 1506 at 10:10-14:14, 33:21-34:3.
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`5
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`
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`There also is no reason to strike paragraphs of Petitioners’ expert
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`Case IPR2017-00190
`Patent 7,214,506 B2
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`declarations that are cited in the Reply by Section number. There is no material
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`difference between Petitioners’ citation to “Ex. 1510 § X” (corresponding to
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`Weinberg ¶¶63-75) and PO’s “block citation” to thirteen paragraphs of Elewski’s
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`report as “Ex. 2027 ¶¶30-34, 38-44, 85.” POR at 10; see also POR at 14 (citing
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`“¶¶45-53” – nine paragraphs), 21 (citing “¶¶64-73” – ten paragraphs). PO misses
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`the mark in arguing that it is now too late for Petitioners to object to PO’s citations.
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`Mot. at 9 n.2. The point is that these paragraphs should not be stricken from the
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`record but should be given their due weight in support of the arguments made in
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`the parties’ briefs. See Nichia Corp. v. Emcore Corp., IPR2012-00005, Paper 68 at
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`59 (PTAB Feb. 11, 2014) (“There is a strong public policy for making all
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`information filed in a non-jury, quasi-judicial administrative proceeding available
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`to the public, especially in an inter partes review.… It is within the Board’s
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`discretion to assign the appropriate weight to be accorded to evidence.”)
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`It is clear from the Reply how Dr. Weinberg’s declaration supports
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`Petitioners’ arguments. For example, page 20 of the Reply cites “Ex. 1510, § X” to
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`rebut PO’s claims that Jublia®’s efficacy was unexpected. Section X addresses
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`secondary considerations, including alleged surprising efficacy. Dr. Weinberg first
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`reminds that efinaconazole’s efficacy was known in the prior art. Ex. 1510 ¶¶63-
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`66, as stated in the Reply at 20 (“efinaconzaole was known to be a potent, effective
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`
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`6
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`
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`antifungal”). Then, Dr. Weinberg explains that Jublia® was, at best, an incremental
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`Case IPR2017-00190
`Patent 7,214,506 B2
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`improvement over Penlac® and other prior art, as stated in the Reply at 20 and 24.
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`Ex. 1510 ¶¶68-70. Dr. Weinberg compares Jublia®’s cure rates to those of Lamisil®
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`and other topical drugs. Id.¶¶71-73. The Reply discusses the same cure rates.
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`Reply at 20 (citing Ex. 1510 ¶¶72, 73). Section X concludes by rebutting alleged
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`praise, citing the same statements quoted in the Reply. Ex. 1510 ¶75; Reply at 21.
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`This case is thus unlike Elec. Arts Inc. v. Terminal Reality, Inc., IPR2016-
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`00929, IPR2016-00930, Paper 50 at 37 (PTAB Oct. 19, 2017), in which the
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`petitioner did not explain at all the relevance of its cited expert testimony regarding
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`a certain reference. Here, the Reply explains Petitioners’ argument, and
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`Petitioners’ expert declarations provide evidentiary support for those arguments.
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`Exhibit 1509 (Walters). PO asks the Board to strike large portions of Dr.
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`Walters’ declaration on the sole basis that the Reply “cites them in bulk form.”
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`Mot. at 13. The request should be rejected, because Petitioners’ citations to Dr.
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`Walters’ declaration are clear and support the arguments made in the Reply.
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`For example, page 13 of the Reply states that Dr. Walters rebuts in detail
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`“Dr. Elewski’s arguments that efinaconazole’s molecular weight and
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`hydrophilicity would have led away from its use in treating onychomycosis,” and
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`cites “Ex. 1509, §§ VIII-X.” There is no mystery as to how Dr. Walters’
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`declaration corresponds to the Reply. Section VIII explains why “Dr. Elewski’s
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`7
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`
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`Attacks on the Molecular Weight of Efinaconazole Lack Merit,” and Section X
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`Case IPR2017-00190
`Patent 7,214,506 B2
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`explains why “Dr. Elewski’s Argument that Hydrophilic Molecules were
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`Disfavored Lacks Merit.” Section IX further explains that “It was Known that KP-
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`103 is not Inactivated by Keratin…,” and that this was a known beneficial property
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`of efinaconazole. The Reply discusses the same properties. Reply at 13-15.
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`PO also criticizes the citation to “Ex. 1509, §§ IV.C, XII-XIII” on page 9 of
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`the Reply for the point that a POSA would have been motivated to use
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`efinaconazole as the antifungal for its known properties. Mot. at 6-7. PO feigns an
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`inability to discern the properties to which Dr. Walters refers. But, Sections IV.C
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`and XII-XIII discuss the same properties that Dr. Walters and Petitioners have
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`cited since the Petition. See, e.g. Ex. 1509 § IV.C, ¶36 (high potency, broad
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`spectrum of activity, long retention time in the horny layer, lack of inactivation by
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`keratin), ¶39 (efficacy against the microorganisms that cause onychomycosis). Dr.
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`Walters explains in detail in §§ XII-XIII how these desirable known properties
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`rebut Dr. Elewski’s opinions; he does not add new obviousness grounds. The fact
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`that these sections contain additional rebuttal to the POR and Dr. Elewski does not
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`detract from the clear discussion of efinaconazole’s properties. PO’s criticisms are
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`unfounded.
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`Dr. Walters’ declaration explains the bases for his opinions with citations to
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`exhibits, systematically pointing out specific flaws in Dr. Elewski’s opinions. This
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`8
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`Case IPR2017-00190
`Patent 7,214,506 B2
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`is appropriate expert testimony, which “explain[s] the ‘how,’ ‘what,’ and ‘why’” of
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`arguments made in Reply. See Kinetic Techs., Inc. v. Skyworks Solutions, Inc.,
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`IPR2014-00529, Paper 8 at 14-15 (PTAB Sept. 23, 2014).
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`Exhibit 1511 (Staines). Mr. Staines responds to PO’s allegations of
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`commercial success, which were made for the first time in the POR. Mr. Staines’
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`declaration is clearly appropriate rebuttal under 37 C.F.R. § 42.23(b). PO tacitly
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`acknowledges as much, but asks to strike significant portions of the declaration
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`solely because the Reply cites large sections of Mr. Staines’ “detailed analysis.”
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`Mot. at 8. Again, PO’s complaints lack merit and ignore the clear correspondence
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`between the Reply and the supporting expert declaration.
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`The Reply explains that the opinion of PO’s expert, Mr. Thomas, is flawed
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`because it is based on “gross Jublia® sales … without consideration of expenses
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`incurred to sell it.” Reply at 22 (citing Ex. 1511 ¶¶26-47). Beginning at paragraph
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`26, Mr. Staines explains that net revenues are the standard measure, and he
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`illustrates how Jublia®’s net revenues are significantly lower than Thomas’ gross
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`sales figures. Ex. 1511 ¶¶26-29 (discussing Staines Exhibit 6). It is apparent from
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`the first few cited paragraphs how Mr. Staines concluded that Thomas improperly
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`relied on gross sales. Mr. Staines appropriately elaborates on the Reply arguments,
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`as expected from an expert declaration that must disclose the underlying facts or
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`data on which the opinion is based. Apple, Inc., IPR2016-01347, Paper 11 at 4.
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`9
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`
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`Common Issues, Exs. 1509-1511. The Motion also should be denied as to
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`Case IPR2017-00190
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`declaration paragraphs not specifically cited in the Reply. PO advances a frivolous
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`request to strike standard introductory paragraphs and even the declarants’ oaths
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`because those paragraphs are not directly cited. Ex. 1509 ¶¶1-7, 133-134; Ex. 1510
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`¶¶1-22, 76-77; Ex. 1511 ¶¶1-11, 55-58, 72-76. PO did not cite the corresponding
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`paragraphs of its declarations: the POR never cites Elewski, Ex. 2027 ¶¶1, 12-29,
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`142-143; Thomas, Ex. 2028 ¶¶1-8, 12-21, 30; or Tatsumi, Ex. 2025 ¶¶1-4, 22.
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`Notably, 19 of the 30 paragraphs of Thomas are not cited in the POR.
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`Petitioners’ expert declarations include a point-by-point rebuttal of the
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`Elewski and Thomas declarations, portions of which were cited in large sections,
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`or not cited at all, in the POR. Those declarations are part of the record. The Board
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`should not strike Petitioners’ rebuttal declarations because they are necessary “to
`
`guide the panel regarding alleged new arguments and/or misrepresentations of
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`evidence” by PO’s declarants. TV Mgmt., Inc. v. Perdiemco LLC, IPR2016-01278,
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`Paper 41 at 5 (PTAB July 26, 2017) (citing 37 C.F.R. § 42.23(b)); see, e.g., Ex.
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`1509, ¶¶ 52, 55, 58-59, 62, 69, 84-86, 89, 94, 96, 107, 109, 111, 112, 125.
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`“[PO] has not provided persuasive reasoning as to why the Board would be
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`confused or prejudiced” by the material it seeks to strike. Hughes Network Sys.,
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`LLC v. Cal. Inst. of Tech., IPR2015-00059, Paper 42 at 40 (PTAB Apr. 21, 2016).
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`Rather than accepting PO’s invitation to evaluate in the abstract whether to strike
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`10
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`individual paragraphs and exhibits, the Board should “consider the argument and
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`evidence of each party to the extent that it is explained sufficiently in the
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`corresponding brief.” Arctic Cat Inc., v. Polaris Indus. Inc., IPR2015-01783, Paper
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`49 at 6 (PTAB Jan. 30, 2017). Indeed, the Board has found that in IPRs, it is “the
`
`better course to have a complete record of the evidence to facilitate public access,
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`as well as appellate review.” Sony Computer Entm’t Am. LLC v. Game Controller
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`Tech. LLC, IPR2013-00634, Paper 32 at 31 (PTAB Apr. 14, 2015).
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`Petitioners’ Exhibits Are Appropriate
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`B.
`PO moves to strike Exhibits 1512 and 1514-1660 solely because these
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`exhibits are not cited directly in the Reply. The exhibits, however, are included in
`
`the Reply’s exhibit list, and are discussed by Petitioners’ experts.3 The Board has
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`rejected similar motions where “the listed exhibits are all discussed, relied upon
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`and cited either in the Petition, Reply or supporting declarations.” Hughes
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`Network Sys., IPR2015-00059, Paper 42 at 40 (emphasis added).
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`PO inappropriately asks that 140 exhibits cited by Mr. Staines be stricken.
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`(Exs. 1515-1517, and 1523-1660). These exhibits properly “disclose the
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`underlying facts or data on which [Mr. Staines’] opinion is based.” 37 C.F.R. §
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`3 Petitioner agrees to withdraw Ex. 1635, which was included inadvertently. There
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`is a typo in Staines Exhibit 3 (cited in Staines ¶23), which should cite Exs. 1637-
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`1645. Ex. 1511 at 112. Ex. 1637 reports the 1999 sales for Lamisil® tablets.
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`11
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`
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`42.65(a). Mr. Staines carefully compiles and analyzes publicly available sales
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`information for Jublia® and its generic competitors to provide a true picture of
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`Jublia®’s net sales and market share, belying PO’s claims of commercial success.
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`Reply at 21-22. Mr. Staines also analyzes published reports of Valeant’s
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`questionable business practices that inflated Jublia® sales. Id. at 22. These are
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`document-intensive undertakings that required extensive research by Mr. Staines.
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`Indeed, Mr. Staines was forced to compile data from various public sources,
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`because PO refused to provide Valeant’s marketing expenditures. See, e.g., Ex.
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`1511 ¶40 (citing Exs. 1585, 1587, 1588 and 1592-1596 for Valeant’s spending on
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`direct-to-consumer advertising); App’x. A (attached) (email dated 8/18/17 from
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`PO’s counsel, refusing to provide discovery).
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`PO’s insistence that the Reply itself cite each of the underlying documents is
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`improper, because the very purpose of expert testimony is to help explain and give
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`context to the underlying evidence. See Sumitomo, IPR2017-00966, Paper 7 at 11.
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`PO itself did not directly cite in the POR any of the exhibits on which its expert,
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`Mr. Thomas, relied. See POR at 63-64 (citing only Ex. 2028 (Thomas)). PO’s
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`assertion of a non-existent, one-sided “direct citation” rule should be rejected.
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`PO also incorrectly states that Exs. 1512, 1521, 1606, 1607, 1624-1634, and
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`1658-1660 “are not cited in any paragraph of Petitioner’s new declarations.” Mot.
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`at 14-15. Exhibit 1512 is cited in Walters (Ex. 1509) ¶20. Exhibit 1521 is cited in
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`12
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`Weinberg (Ex. 1510) ¶59. The remaining exhibits are cited by Mr. Staines (Ex.
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`Case IPR2017-00190
`Patent 7,214,506 B2
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`1511), as follows: Ex. 1606 (¶55); Ex. 1607 (¶60); Exs. 1624-1626 (¶72), Exs.
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`1627-1631, 1658-1660 (¶73); Exs. 1632-1634 (¶74). Thus, similar to its POR and
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`expert declarations, PO advances misleading arguments in its Motion.4
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`The motion to strike also should be denied as to the seven exhibits cited by
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`Drs. Walters and Weinberg. Exs. 1512 and 1518 are publications co-authored Dr.
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`Elewski. In Ex. 1512, Dr. Elewski recognized that onychomycosis includes
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`infection of skin structures, contrary to her claim construction arguments. Ex. 1509
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`¶20. In Ex. 1518, Dr. Elewski characterized onchyomycosis as difficult to manage
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`even after Jublia® became available, contrary to her claims that Jublia® was a
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`“breakthrough.” Ex. 1510 ¶¶24, 68; Reply at 20 (citing Ex. 1510 §X (¶¶63-75)).
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`Ex. 1522 is cited in Weinberg §X (¶68) as the source for comparative cure
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`rate data, like that discussed in the Reply (p. 20). Exs. 1519-1521 are labels for
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`prior art topical products, cited by Dr. Weinberg (Ex. 1510 ¶¶ 57, 59(3)) in
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`response to Dr. Elewski’s opinions. Ex. 1514 is cited by Dr. Walters (Ex. 1509, ¶¶
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`66, 71) to rebut Elewski’s discussion of Ogura. Citation of each of these exhibits
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`complies with the requirement of 37 C.F.R. § 42.65(a) that experts disclose the
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`4 PO even misrepresented the facts to its experts by not giving them the full Kaken
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`Abstracts (Exs. 2036-2038) and its actual revenues and expenses. Reply, 12, 21-22.
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`13
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`facts and data underlying their analysis. The exhibits should remain in the record.
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`Case IPR2017-00190
`Patent 7,214,506 B2
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`Petitioners’ Reply Raises No “New Legal Theory”
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`C.
`The Motion purposefully conflates two separate points in the Reply that
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`reference PO’s earlier efinaconzole patents (Exs. 1007 and 1505) to make its
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`baseless claim that the Reply introduced a “new legal theory.”
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`First, PO focuses on a half-sentence of the Reply and Dr. Walters’
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`declaration which observes that PO’s prior efinaconazole patents recite the same
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`preferred amount of antifungal agent as the ’506 patent and the cited art: JP ’639.
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`Reply at 9; Ex. 1509 ¶29 (responding to Elewski (Ex. 2027) ¶¶108-110). This brief
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`reference is not a new obviousness argument. Cf. Mot. at 11. Petitioners have not
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`altered the instituted grounds. The exact sentence of the Reply and Dr. Walters’
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`declaration that PO would strike clearly relies on the fact that JP ’639 discloses an
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`amount of antifungal agent that matches the ’506 patent’s preferred range. Reply at
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`9; Ex. 1509 ¶29. The Institution Decision recognized this fact. Paper 12 at 9, 16.
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`Second, PO attacks Petitioners’ argument that PO’s earlier patents blocked
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`others from making “any fungicide composition comprising efinaconazole,”
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`eliminating the implication that alleged commercial success or “unmet needs”
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`suggest nonobviousness. Reply at 19. Petitioners’ discussion of blocking patents
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`only responds to PO’s alleged secondary considerations presented for the first time
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`in the POR. Petitioners were not required to present this rebuttal evidence in the
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`14
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`Case IPR2017-00190
`Patent 7,214,506 B2
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`Petition when they did not know what secondary considerations, if any, PO would
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`assert. Petitioners’ arguments are manifestly proper under 37 C.F.R. § 42.23(b).
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`PO spuriously suggests that Petitioners did not rely on the blocking patents
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`in the Petition because of a conflict with Petitioners’ argument that PO’s priority
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`document contained no description of treating onychomycosis. Mot. at 12. PO
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`ignores that “a description that merely renders the invention obvious does not
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`satisfy the [written description] requirement.” Ariad Pharms., Inc. v. Eli Lilly &
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`Co., 598 F.3d 1336, 1352 (Fed. Cir. 2010). Moreover, Petitioners do not argue
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`obviousness based on the blocking patents. There is no inconsistency between
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`arguing lack of written description for treating onychomycosis and arguing PO’s
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`prior broad patent claims blocked others from using efinaconazole as a compound,
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`as a pharmaceutical composition, and in any method for treating any mycosis.
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`PO was aware of its own blocking patents and should have addressed them
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`in the POR when it attempted to rely on secondary considerations. If PO had any
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`substantive response, it could have requested a sur-reply. Tellingly, PO only seeks
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`the Draconian result of striking Petitioners’ proper rebuttal arguments and exhibits.
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`III. CONCLUSION
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`For the above reasons, Petitioners request denial of the Motion to Strike.
`
`Date: December 6, 2017
`
`By:
`
`/s/ Aydin H. Harston
`Aydin H. Harston, Reg. No. 65,249
`Counsel for Petitioners
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`15
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`CERTIFICATE OF SERVICE
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`Case IPR2017-00190
`Patent 7,214,506 B2
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`By:
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`The undersigned certifies that a copy of the foregoing PETITIONERS’
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`RESPONSE TO PATENT OWNER’S MOTION TO STRIKE was served
`electronically via email on December 6, 2017, in its entirety on the following:
`John D. Livingstone
`john.livingstone@finnegan.com
`KakenIPR@finnegan.com
`Finnegan, Henderson, Farabow, Garrett & Dunner, L.L.P.
`271 17th Street, N.W., Suite 1400
`Atlanta, GA 30363-6209
`
`Naoki Yoshida
`naoki.yoshida@finnegan.com
`Anthony Hartmann
`anthony.hartmann@finnegan.com
`Barbara R. Rudolph, Ph.D.
`barbara.rudolph@finnegan.com
`Finnegan, Henderson, Farabow, Garrett & Dunner, L.L.P.
`901 New York Ave., N.W.
`Washington, DC 20001-4413
`
`Toan P. Vo
`toan.vo@bausch.com
`Valeant Pharmaceuticals North America LLC
`1400 N. Goodman Street
`Rochester, NY 14609
`
`/s/ Aydin H. Harston_______________
`E. Anthony Figg, Reg. No. 27,195
`Aydin H. Harston, Reg. No. 65,249
`ROTHWELL, FIGG, ERNST & MANBECK, P.C.
`607 14th St., N.W., Suite 800
`Washington, DC 20005
`Phone: 202-783-6040 | Fax: 202-783-6031
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`Counsel for Petitioners
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`APP'X. A
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`APP'X. A
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`
`
`Nasri Hage
`
`From:
`Sent:
`To:
`Cc:
`Subject:
`
`Hartmann, Anthony <anthony.hartmann@finnegan.com>
`Friday, August 18, 2017 1:09 PM
`Aydin Harston; E. Anthony Figg; LITIGATION PARALEGALS
`KakenIPR; Livingstone, John; toan.vo@bausch.com; Yoshida, Naoki
`RE: ACRUX DDS PTY LTD. & ACRUX LIMITED v. KAKEN PHARMACEUTICAL CO., LTD.
`Case IPR2017-00190
`
`Dear Aydin,
`
`
`Further to our email, we consulted with our client about Petitioner’s request for additional discovery regarding
`“marketing spend” under 37 C.F.R. § 42.51(b)(2). We do not agree to your request for additional discovery.
`
`
`Regards,
`Tony
`
`Anthony A. Hartmann
`Of Counsel
`Finnegan, Henderson, Farabow, Garrett & Dunner, LLP
`901 New York Avenue, NW, Washington, DC 20001-4413
`+1 202 408 4275 | fax +1 202 408 4400 | anthony.hartmann@finnegan.com | www.finnegan.com
`
`
`
`
`From: Hartmann, Anthony
`Sent: Friday, August 11, 2017 2:28 PM
`To: 'Aydin Harston'; E. Anthony Figg; LITIGATION PARALEGALS
`Cc: KakenIPR; Livingstone, John; toan.vo@bausch.com; Yoshida, Naoki
`Subject: RE: ACRUX DDS PTY LTD. & ACRUX LIMITED v. KAKEN PHARMACEUTICAL CO., LTD. Case IPR2017-00190
`
`Dear Aydin,
`
`“US_ _ _ 20170531(2).xlsx” and “012617 Jublia 4mEq Commercial Market Comparison.xlsx” are Exhibit 2095 and Exhibit
`2093, respectively. Accordingly, Patent Owner has provided the information upon which Exhibit 2098 and Exhibit 2099
`are “based on.” All information that Mr. Thomas has relied on has been produced to Petitioners. Patent Owner believes
`that it has complied with the requirements of 37 C.F.R. § 42.51(b)(1).
`
`As to your request for additional discovery under 37 C.F.R. § 42.51(b)(2) regarding “marketing spend,” we will consider
`your request with our client.
`
`Regards,
`Tony
`
`Anthony A. Hartmann
`Of Counsel
`Finnegan, Henderson, Farabow, Garrett & Dunner, LLP
`901 New York Avenue, NW, Washington, DC 20001-4413
`+1 202 408 4275 | fax +1 202 408 4400 | anthony.hartmann@finnegan.com | www.finnegan.com
`
`
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`1
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`From: Aydin Harston [mailto:aharston@rothwellfigg.com]
`Sent: Thursday, August 10, 2017 1:16 PM
`To: Hartmann, Anthony; E. Anthony Figg; LITIGATION PARALEGALS
`Cc: KakenIPR; Livingstone, John; toan.vo@bausch.com; Yoshida, Naoki
`Subject: ACRUX DDS PTY LTD. & ACRUX LIMITED v. KAKEN PHARMACEUTICAL CO., LTD. Case IPR2017-00190
`
`Dear Tony,
`
` I write to request that PO provide “US_ _ _ 20170531(2).xlsx” and “012617 Jublia 4mEq Commercial Market
`Comparison.xlsx,” in addition to any other document or information underlying the preparation of Exhibits 2093‐2095
`and 2098‐2099, to Petitioners immediately. PO’s commercial success expert, Mr. Vincent A. Thomas, has relied upon
`Exhibits 2098 and 2099 in his analysis. According to Mr. Thomas’ Declaration, these exhibits are “based on” the
`underlying documents which were not provided with the POR. See EX. 2028, n.3‐4 (Exhibit 2098 is “based on US_ _ _
`20170531(2).xlsx” and Exhibit 2099 is “based on 012617 Jublia 4mEq Commercial Market C
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