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`Paper _____
`
`Filed: January 5, 2018
`
`
`
`
`
`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’ OPPOSITION TO PATENT OWNER’S MOTION TO
`EXCLUDE UNDER 37 C.F.R. § 42.64(c)
`
`
`
`
`
`
`
`                                                            
`1 Case IPR2017-01429 has been joined with the instant proceeding.
`
` 
`
` 
`
`

`

`TABLE OF CONTENTS
`
`TABLE OF AUTHORITIES .................................................................................... ii 
`
`I. 
`
`II. 
`
`INTRODUCTION ........................................................................................... 1 
`
`ARGUMENT ................................................................................................... 1 
`
`A. 
`
`B. 
`
`C. 
`
`The Ogura Reference (Ex. 1012) Is Not Hearsay Because
`PO Has Repeatedly Admitted That It Published In 1999. .................... 1 
`
`The Arika Reference (Ex. 1513) Is Relevant, Properly
`Authenticated, and Not Hearsay. ........................................................... 4 
`
`Exs. 1512, 1522, 1524, 1525, 1527-1549, 1551, 1553, 1554,
`1555, 1557-1560, 1566, 1569, 1576, 1577, 1580-1585,
`1588, 1594, 1599, 1603-1605, 1607, 1609, 1613, 1617,
`1619, 1621, 1623, 1626-1629, 1632-1636, 1638-1645,
`1658, and 1660 Are Admissible ............................................................ 7 
`
`1.  Many of the Above-Identified Exhibits Are Self-
`Authenticating ................................................................................. 7 
`
`2. 
`
`3. 
`
`Exs. 1547, 1551, 1617, 1636, and 1638-1645 Are
`Sufficiently Authenticated .............................................................. 9 
`
`Exs. 1529, 1535, 1553, 1554, 1569, 1576, 1582-1585,
`1588, 1603, 1604, 1658 and 1660 Are Not Webpages
`and PO Does Not Otherwise Challenge Their
`Admissibility ................................................................................. 10 
`
`D.  All Parts of Dr. Walters’ Declarations (Exhibits 1005 and
`1509) Are Admissible ......................................................................... 11 
`
`E. 
`
`PO’s Motion Is Akin To An Unauthorized Sur-Reply ....................... 15 
`
`
`
`i 
`
`
`
` 
`
`

`

` 
`
`TABLE OF AUTHORITIES
`
`Case IPR2017-00190
`Patent 7,214,506 B2
`
`Cases 
`Alexander v. CareSource,
`576 F.3d 551 (6th Cir. 2009) .................................................................................. 8
`
`Arachnid, Inc. v. Valley Rec. Prods., Inc.,
`2001 U.S. Dist. LEXIS 22460 (N.D. Ill. Dec. 27, 2001) ........................................ 8
`
`B/E Aerospace v. Mag Aerospace Indus.,
`IPR2014-01510, Paper 106 (PTAB Mar. 18, 2016) ............................................. 11
`
`Ciampi v. City of Palo Alto,
`790 F. Supp. 2d 1077 (N.D. Cal. 2011) .................................................................. 8
`
`Daubert v. Merrell Dow Pharms.,
`509 U.S. 579 (1993) .............................................................................................. 12
`
`EMC Corp. v. PersonalWeb Tech.,
`IPR2013-00083, Paper 80 (PTAB May 15, 2014) ................................................. 3
`
`EMC Corp. v. PersonalWeb Techs., LLC,
`IPR2013-00084, Paper 64 (PTAB May 15, 2014) ............................................... 10
`
`Ericsson Inc. v. Intellectual Ventures I LLC,
`IPR2014-00527, Paper 41 (PTAB May 18, 2015) .............................................3, 7
`
`FLIR Sys., Inc. v. Leak Surveys, Inc.,
`IPR2014-00411, Paper 9 (PTAB Sept. 5, 2014) ..................................................... 3
`
`Ford Motor Co. v. Cruise Control Techs., LLC,
`IPR2014-00291, Paper 44 (PTAB June 29, 2015) ................................................. 3
`
`Indiana ex rel. Naylor v. Indiana State Teachers Ass’n,
`950 F. Supp. 2d 993 (S.D. Ind. 2013) ..................................................................... 8
`
`Liberty Mutual Ins. Co. v. Progressive Casualty Ins. Co.,
`CBM2012-00002, Paper 66 (PTAB Jan. 23, 2014) ......................................... 1, 15
`
`Merck Sharp & Dohme Corp. v. Mayne Pharma Int’l Pty Ltd.,
`IPR2016-01186, Paper 10 (PTAB Dec. 19, 2016) .................................... 4, 5, 7, 8
`
` 
`
`ii
`
`

`

` 
`Mobotix Corp. v. Comcam Int’l, Inc.,
`IPR2015-00093, Paper 22 (PTAB Apr. 28, 2016) ................................................. 5
`
`Case IPR2017-00190
`Patent 7,214,506 B2
`
`Premier Nutrition, Inc. v. Organic Food Bar, Inc.,
`86 U.S.P.Q.2D 1344 (C.D. Cal. 2008) ............................................................ 9, 10
`
`Seabery N. Am., Inc. v. Lincoln Global, Inc.,
`IPR2016-00840, Paper 60 (PTAB Oct. 2, 2017) .................................................... 3
`
`Search Am., Inc. v. Transunion Intelligence, LLC,
`CBM2013-00037, Paper 67 (PTAB Feb. 3, 2015) ............................................... 12
`
`Sk Innovation Co., Ltd. v. Celgard, LLC,
`IPR2014-00680, Paper 57 (PTAB Sept. 25, 2015) ................................................. 6
`
`TCL Corp. v. Telefonaktiebolaget LM Ericsson,
`IPR2015-01600, Paper 75 (PTAB Jan. 24, 2017) .................................................. 5
`
`Victaulic Co. v. Tieman,
`499 F.3d 227 (3d Cir. 2007), as amended (Nov. 20, 2007) .................................... 9
`
`Regulations 
`
`37 C.F.R. § 42.12 ..................................................................................................... 14
`
`37 C.F.R. § 42.20(c) ................................................................................................... 1
`
`37 C.F.R. § 42.62(a) ................................................................................................... 1
`
`Rules 
`
`Federal Rule of Evidence 702 ........................................................................... 11, 12
`
`Federal Rule of Evidence 703 .................................................................................... 6
`
`Federal Rule of Evidence 801 ................................................................................2, 5
`
`Federal Rule of Evidence 803 ........................................................................... 4, 5, 7
`
`Federal Rule of Evidence 807 ................................................................................4, 7
`
`Federal Rule of Evidence 902 ............................................................... 5, 8, 9, 10, 11
`
`
`
` 
`
`iii
`
`

`

`I.
`
`INTRODUCTION
`
`Pursuant to the Scheduling Order (Paper No. 13), Acrux DDS PTY Ltd.,
`
`Acrux Limited, and Argentum Pharmaceuticals LLC (collectively, “Petitioners”)
`
`oppose Patent Owner’s Motion to Exclude (Paper No. 58, “Motion”). Patent
`
`Owner (“PO”) failed to carry its burden of proving entitlement to the relief
`
`requested. See 37 C.F.R. §§ 42.20(c), 42.62(a). Given “the Board’s discretion to
`
`assign the appropriate weight to be accorded to evidence… it is better to have a
`
`complete record of the evidence submitted by the parties than to exclude particular
`
`pieces.” Liberty Mutual Ins. Co. v. Progressive Casualty Ins. Co., CBM2012-
`
`00002, Paper 66 at 60 (PTAB Jan. 23, 2014). Thus, for the reasons discussed in
`
`detail below, the Motion should be denied.
`
`II. ARGUMENT
`
`A. The Ogura Reference (Ex. 1012) Is Not Hearsay Because PO Has
`Repeatedly Admitted That It Published In 1999.
`PO’s allegation that Ogura’s publication date is hearsay lacks merit for
`
`several reasons. First, PO is the institutional author of Ogura (Ex. 1012) and
`
`admitted Ogura’s October 1999 publication date in its Information Disclosure
`
`Statement (“IDS”) listing “Ogura, Hironobu et al., Chem. Pharm. Bull, Vol. 47
`
`(No. 10), p. 1417-1425, (October, 1999),” during prosecution of the ’506
`
` 
`
`1 
`
`

`

` 
`Patent. Ex. 1006, 230-233 (emphasis added).2
`
`Case IPR2017-00190
`Patent 7,214,506 B2
`
`Second, PO’s employee witness and named inventor, Dr. Tatsumi, admitted
`
`in Ex. 2024/Ex. 2025 (English translation of Ex. 2024), ¶ 13 that “[w]e published
`
`the data in 1999 in an article . . . by Ogura et al. I understand the article has been
`
`cited in the Inter Partes Review as Exhibit 1012.”
`
`Third, Dr. Tatsumi also corroborated Ogura’s 1999 publication date in
`
`Kaken Ex. 2016, at 3801 (Reference “16. Ogura, H… 1999. Synthesis and
`
`antifungal activities of (2R, 3R)-2-aryl-1-azolyl-3-(substituted amino)-2-butanol
`
`derivatives as a topical antifungal agent. Chem. Pharm. Bull. 47:1417–1425.”).
`
`Given these admissions by PO and its employee and named inventor on the
`
`’506 patent prior to and during this inter partes review, as well as its
`
`representatives’ sworn statements during prosecution of the patent, Ogura’s
`
`publication date is not hearsay under Federal Rule of Evidence (“FRE”) 801(d)(2).
`
`Further, PO’s Motion ignores Petitioners’ Supplemental Evidence timely
`
`served on May 30, 2017 and filed herewith as Ex. 1668, at 20-32, which is a
`
`library-stamped copy of Chemical & Pharmaceutical Bulletin, October 1999, Vol.
`
`47, No. 10 with the copyright page and Table of Contents. The October 1999
`
`                                                            
`2 On January 12, 2017, PO filed an IDS in the ’506 patent reissue application and
`
`again listed Ogura’s publication date as October 1999. Ex. 1667, at 94-98, at 97.
`
` 
`
`2
`
`

`

` 
`journal date and the 1999 date in the copyright notice on Ogura (Ex. 1668, at 20-
`
`Case IPR2017-00190
`Patent 7,214,506 B2
`
`22) are not inadmissible hearsay because they are not assertions. Seabery N. Am.,
`
`Inc. v. Lincoln Global, Inc., IPR2016-00840, Paper 60 at 5-6 (PTAB Oct. 2, 2017).
`
`Instead, these dates serve a non-hearsay purpose—namely to prove that the
`
`document was available publicly as of that date. Id.; EMC Corp. v. PersonalWeb
`
`Tech., IPR2013-00083, Paper 80 at 38-39 (PTAB May 15, 2014). Further, dates in
`
`a copyright notice have been found to be prima facie evidence of publication dates.
`
`FLIR Sys., Inc. v. Leak Surveys, Inc., IPR2014-00411, Paper 9 at 18-19 (PTAB
`
`Sept. 5, 2014) (“we are persuaded that the Copyright notice prima facie establishes
`
`a prior art date of 2002.”); Ford Motor Co. v. Cruise Control Techs., LLC,
`
`IPR2014-00291, Paper 44 at 8 (PTAB June 29, 2015) (“The inference that a
`
`copyright notice bearing the symbol “©” provides some evidence of a date of
`
`publication finds support in the understanding that such markings generally
`
`indicate the ‘first year of publication.’”).
`
`Even if considered hearsay, the date of Ogura would fall within at least two
`
`hearsay exceptions: First, the information published on the copyright line of
`
`Ogura, including the 1999 date and the publisher, Pharmaceutical Society of Japan,
`
`is generally relied on by members of the scientific community who both publish
`
`and engage in research. Ericsson Inc. v. Intellectual Ventures I LLC, IPR2014-
`
`00527, Paper 41 at 10-12 (PTAB May 18, 2015). Thus, this information falls under
`
` 
`
`3
`
`

`

` 
`FRE 803(17) as an exception to the hearsay rule. Second, the indicia on the first
`
`Case IPR2017-00190
`Patent 7,214,506 B2
`
`page of Ogura, including the name of the journal, the volume number, publication
`
`date, the copyright notice, and the library stamp, as corroborated by PO’s multiple
`
`statements to the Office and in its other publications, provide circumstantial
`
`guarantees of trustworthiness that meet the requirements outlined in FRE 807, the
`
`residual hearsay exception. Id.; Merck Sharp & Dohme Corp. v. Mayne Pharma
`
`Int’l Pty Ltd., IPR2016-01186, Paper 10 at 14-15 (PTAB Dec. 19, 2016); FRE 807.
`
`B. The Arika Reference (Ex. 1513) Is Relevant, Properly Authenticated,
`and Not Hearsay.
`PO’s arguments regarding Arika lack merit given that PO is the institutional
`
`author of Arika (Ex. 1513) as disclosed in Ogura (Ex. 1012), which explains the
`
`relevant disclosure of Arika (cited as Reference 13 in Ogura):
`
`We next examined the effects of keratin (human hair) on anti-T.
`mentagrophytes activity. In general, the activities of most topical
`antifungal agents are greatly reduced by adsorption to keratin,13)
`which is a major constituent of the keratinized tissue where fungi
`reside . . . . [t]hese results indicated that 4-methylpiperidino triazole
`derivative (40) had low affinity to keratin and could retain a high level
`of activity in the keratinized tissue.14).
`Ex. 1012, at 1420.
`
`The relevance of Arika is further explained in Dr. Walters’ Declaration. See
`
`Ex. 1509, ¶¶ 24, 26, 56, 57, 59, 65, 66, 69, 71, 91, 98, 102, 115. PO’s argument
`
` 
`
`4
`
`

`

` 
`appears to be directed to the weight to be afforded to Dr. Walters’ discussion of
`
`Case IPR2017-00190
`Patent 7,214,506 B2
`
`Arika rather than its relevance. However, “[s]imilar to a district court in a bench
`
`trial, the Board, sitting as a non-jury tribunal with administrative expertise, is well-
`
`positioned to determine and assign appropriate weight to evidence presented.”
`
`Mobotix Corp. v. Comcam Int’l, Inc., IPR2015-00093, Paper 22 at 3 (PTAB Apr.
`
`28, 2016). Thus, PO’s relevance arguments lack merit and should be rejected.
`
`Further, articles
`
`in periodicals are self-authenticating under FRE
`
`902(6). See, e.g., Merck Sharp & Dohme Corp., IPR2016-01186, Paper 10 at 14-
`
`15; TCL Corp. v. Telefonaktiebolaget LM Ericsson, IPR2015-01600, Paper 75 at
`
`21-22 (PTAB Jan. 24, 2017). As Arika is a journal article, it is self-authenticating.
`
`Ogura constitutes a statement made by PO and its employees, including Dr.
`
`Tatsumi, on a matter within the scope of their relationship and while it existed.
`
`Given these party admissions, the publication date of Arika - admitted in Ogura - is
`
`not hearsay. FRE 801(d)(2). In addition, as it is self-authenticating under FRE
`
`902(6) and was published in 1990, contrary to PO’s argument (Motion, 5-7), Arika
`
`qualifies for the ancient document hearsay exception. FRE 803(16).
`
`Moreover, Petitioners are not relying on the 1990 publication date of Arika,
`
`but rather have properly made Arika of record in this case as it constitutes evidence
`
`of what was known prior to the critical date for the ’506 patent. As Arika’s
`
` 
`
`5
`
`

`

` 
`disclosure was discussed in Ogura (Ex. 1012), it was necessarily published before
`
`Case IPR2017-00190
`Patent 7,214,506 B2
`
`1999. Thus, PO’s Ogura publication corroborates Arika’s earlier publication date.
`
`Further, Ogura (Ex. 1012) and Arika (Ex. 1513) comprise evidence on
`
`which Petitioners’ expert, Dr. Walters, has relied in forming his opinions regarding
`
`the state of the art in the 1990s. See Ex. 1509, ¶ 24. “An expert may base an
`
`opinion on facts or data in the case that the expert has been made aware of.” FRE
`
`703. The Board may admit alleged hearsay exhibits underlying an expert opinion
`
`under FRE 703 because the Board is not a lay jury. Sk Innovation Co., Ltd. v.
`
`Celgard, LLC, IPR2014-00680, Paper 57 at 27-28 (PTAB Sept. 25, 2015).
`
`PO’s Motion also ignores Petitioners’ Supplemental Evidence timely served
`
`on November 22, 2017 and filed herewith as Ex. 1513(a), which is a library-
`
`stamped copy of the periodical Nishi Nihon Journal of Dermatology, 52(3): 545-
`
`549 (1990) with the copyright page and Table of Contents. See also, Ex. 1669, ¶ 1.
`
`The 1990 journal date and the 1990 date in the copyright notice on Arika (Ex. 1513
`
`and 1513(a)) are not inadmissible hearsay because dates are not assertions, as
`
`discussed in Section II.B supra.
`
`Even if hearsay, the date of Arika would fall within at least two other
`
`hearsay exceptions: First, the information published on the copyright line of Arika,
`
`including the 1990 date and the publisher, Nishi Nihon Journal of Dermatology,
`
`are generally relied on by members of the scientific community who both publish
`
` 
`
`6
`
`

`

` 
`and engage in research and, thus, fall under an exception to the hearsay rule.
`
`Case IPR2017-00190
`Patent 7,214,506 B2
`
`Ericsson Inc., IPR2014-00527, Paper 41 at 10-12; FRE 803(17). Second, the
`
`indicia on the first page of Arika, including the name of the journal, the volume
`
`number, publication date, the copyright notice, and the library stamp, as
`
`corroborated by Arika’s citation in Ex. 1012, provide circumstantial guarantees of
`
`trustworthiness that meet the requirements outlined in the residual hearsay
`
`exception. Id.; Merck Sharp & Dohme Corp., IPR2016-01186, Paper 10 at 14-15;
`
`FRE 807. Therefore, PO’s Motion to Exclude Arika (Ex. 1513) should be denied.
`
`C. Exs. 1512, 1522, 1524, 1525, 1527-1549, 1551, 1553, 1554, 1555, 1557-
`1560, 1566, 1569, 1576, 1577, 1580-1585, 1588, 1594, 1599, 1603-1605,
`1607, 1609, 1613, 1617, 1619, 1621, 1623, 1626-1629, 1632-1636, 1638-
`1645, 1658, and 1660 Are Admissible3
`1. Many of the Above-Identified Exhibits Are Self-Authenticating
`
`PO argues that “[e]ach of these exhibits is a copy of a webpage, which… is
`
`not self-authenticating...” Motion, 8. However, Exs. 1525, 1527, 1528, 1531-
`
`1533, 1537, 1539, 1544-1546, 1549, 1555, 1558-1559, 1566, 1594, 1607, 1627-
`
`1628, and 1633-1634 are articles from online news sources and newspapers,
`
`                                                            
`3 Supplemental evidence was timely served on November 22, 2017, including,
`
`Exs. 1522(a), 1535(a), 1543(a), 1544(a), 1547(a), 1553(a), 1554(a), 1588(a),
`
`1603(a), 1604(a), 1619(a), 1623(a), and 1626(a) along with four supporting
`
`declarations (Exs. 1669-1672), and all are filed herewith.
`
` 
`
`7
`
`

`

` 
`including, The Wall Street Journal, The New York Times, Reuters, The Los
`
`Case IPR2017-00190
`Patent 7,214,506 B2
`
`Angeles Times, Bloomberg, and The San Francisco Gate. These exhibits are
`
`analogous to traditional newspaper articles and, have been held self-authenticating
`
`under FRE 902(6). Indiana ex rel. Naylor v. Indiana State Teachers Ass’n, 950 F.
`
`Supp. 2d 993, 1007 n.15 (S.D. Ind. 2013) (holding that an online newspaper article
`
`“is self-authenticating and requires no extrinsic evidence of authenticity to be
`
`admitted.”). Exs. 1599, 1605 and 1613 are press releases and have also been held
`
`self-authenticating under FRE 902(6). Arachnid, Inc. v. Valley Rec. Prods., Inc.,
`
`2001 U.S. Dist. LEXIS 22460, at *12 (N.D. Ill. Dec. 27, 2001).
`
`Similarly, Exs. 1512, 1522, 1524, 1530, 1534, 1538, 1540-1543, 1548, 1557,
`
`1560, 1580-1581, 1619, 1621, 1623, 1626, 1629, 1632 and 1635 are articles from
`
`online periodicals including Business Insider, Financial Times, Forbes, Fortune,
`
`The Atlantic Monthly and The Journal of the American Academy of Dermatology.
`
`Such articles have been held self-authenticating under FRE 902(6) when they
`
`“contain sufficient indicia of authenticity, including… dates of publication, page
`
`numbers, and web addresses,” as are included in each of these exhibits. Ciampi v.
`
`City of Palo Alto, 790 F. Supp. 2d 1077, 1091 (N.D. Cal. 2011). See also, Merck
`
`Sharp & Dohme Corp., IPR2016-01186, Paper 10 at 14-15.
`
`Documents which “contain… a trade inscription indicating the source of
`
`origin of the document” are also self-authenticating under FRE 902(7). Alexander
`
` 
`
`8
`
`

`

` 
`v. CareSource, 576 F.3d 551, 561 (6th Cir. 2009) (holding a letter on company
`
`Case IPR2017-00190
`Patent 7,214,506 B2
`
`letterhead was self-authenticating under FRE 902(7)). Each of Exs. 1536 (showing
`
`AMCP logo and “Approved by AMCP Board April 2012”), 1577 (showing RBC
`
`Capital Markets logo and “Copyright © RBC Capital Markets, LLC 2017”), and
`
`1609 (showing Kantar logo and “Source: Kantar Media”) include sufficient self-
`
`authenticating information.
`
`2. Exs. 1547, 1551, 1617, 1636, and 1638-1645 Are Sufficiently
`Authenticated
`
`The subject exhibits are website printouts that include web addresses and the
`
` 
`
`dates printed in the margins. Petitioners supplemented this evidence with
`
`declarations explaining how each was located and declared that each was a true
`
`and correct copy of the corresponding webpage. See Exs. 1672, ¶¶ 28 (Exs. 1547
`
`and 1547(a)), 32 (Ex. 1551), 92 (Ex. 1617), 108 (Ex. 1636); Ex. 1669, ¶¶ 19-26
`
`(Exs. 1638-1645). Thus, Petitioners’ supplemental evidence has “sufficiently
`
`authenticated” these exhibits. Premier Nutrition, Inc. v. Organic Food Bar, Inc.,
`
`86 U.S.P.Q.2D 1344, 1349 (C.D. Cal. 2008) (citation omitted).
`
`The cases on which PO relies for the proposition that “a web master or
`
`someone else with personal knowledge” of the website must provide testimony to
`
`properly authenticate webpage printouts are distinguishable. Motion, 8. In
`
`Victaulic Co. v. Tieman, 499 F.3d 227, 236 (3d Cir. 2007), as amended (Nov. 20,
`
` 
`
`9
`
`

`

` 
`2007), the court determined that, because a private corporate website was
`
`Case IPR2017-00190
`Patent 7,214,506 B2
`
`“generally… not the sort… of ‘source… whose accuracy cannot reasonably be
`
`questioned,’” the district court improperly took judicial notice of facts included in
`
`it without any authenticating information. Id. In EMC Corp. v. PersonalWeb
`
`Techs., LLC, IPR2013-00084, Paper 64, at 45 (PTAB May 15, 2014), the
`
`authentication issue was connected to establishing whether the website was
`
`publicly available prior to the critical date, requiring a declaration from someone
`
`with personal knowledge of the website’s search engine functions, archiving and
`
`storage practices. Id. Here, the circumstances are different and require no more
`
`than what has been supplied.4
`
`3. Exs. 1529, 1535, 1553, 1554, 1569, 1576, 1582-1585, 1588, 1603,
`1604, 1658 and 1660 Are Not Webpages and PO Does Not Otherwise
`Challenge Their Admissibility
`
`PO seeks exclusion of the exhibits listed in Section II.A.3. of its Motion
`
`solely on the basis that “[e]ach of these exhibits is a copy of a webpage, which has
`
`not been properly authenticated.” Motion, 8. However, Exs. 1529, 1535, 1553,
`
`1554, 1569, 1576, 1582-1585, 1588, 1603, 1604, 1658 and 1660 are not
`
`                                                            
`4 To the extent that any of the remaining exhibits do not qualify under FRE
`
`902(6) or FRE 902(7) as discussed above, they would be sufficiently authenticated
`
`as described in Premier Nutrition, Inc., 86 U.S.P.Q.2D at 1349.
`
` 
`
`10
`
`

`

` 
`webpages.5 Thus, PO has presented no argument in support of exclusion of these
`
`Case IPR2017-00190
`Patent 7,214,506 B2
`
`exhibits.
`
`D. All Parts of Dr. Walters’ Declarations (Exhibits 1005 and 1509) Are
`Admissible
`PO seeks to exclude certain paragraphs of Dr. Walters’ expert declarations
`
`on grounds that he is not qualified under FRE 702. Motion, 9-14. PO’s Daubert
`
`challenge to exclude Dr. Walters’ expert testimony is not only baseless, but it has
`
`little applicability in an IPR proceeding. The Board recognizes that “the policy
`
`considerations for excluding expert testimony, such as those implemented by the
`
`gatekeeping framework established by the Supreme Court in Daubert[], are less
`
`compelling in bench proceedings such as inter partes reviews than in jury trials.”
`
`B/E Aerospace v. Mag Aerospace Indus., IPR2014-01510, Paper 106 at 9 (PTAB
`
`                                                            
`5 Exs. 1553(a), 1554(a), 1588(a), 1603(a), 1604(a) are Valeant SEC filings
`
`obtained first from sec.gov, then supplemented with the same filings obtained
`
`through Valeant’s website. Ex. 1672, ¶¶ 34-37, 66-67, 79-82. They are self-
`
`authenticating under FRE 902(4) as copies of documents “filed in a public office”
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`and including a certificate that complies with a federal statute signed by Valeant’s
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`own representatives. See, e.g., Ex. 1553(a), at 189. Curiously, PO does not seek to
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`exclude Exs. 1587 and 1630 which are also Valeant SEC filings.
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`Mar. 18, 2016). See also, Daubert v. Merrell Dow Pharms., 509 U.S. 579, 597
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`(1993). PO shows no basis to exclude Dr. Walters’ opinions under FRE 702.
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`Instead, PO’s challenges go to the weight, rather than the admissibility, of
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`Dr. Walters’ testimony. See, e.g., Search Am., Inc. v. Transunion Intelligence,
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`LLC, CBM2013-00037, Paper 67 at 13 (PTAB Feb. 3, 2015) (criticism of an
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`expert’s methodology “go to the weight that should be accorded his testimony and
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`not to the admissibility of that testimony”).
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`Moreover, PO’s challenges are completely devoid of merit. As stated in the
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`Institution Decision:
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`We are mindful that the level of ordinary skill in the art is reflected by
`the prior art of record… The art asserted against the claims in the
`Petition shows the overlap between treatment of fungal infections of
`skin and nails. Paper No. 12, 11.
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`PO argues that Dr. Walters’ testimony evidences he is not qualified in the
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`relevant art based on its mischaracterization that the Institution Decision “requires
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`experience in specifically treating nail infections.” Motion, 10-11. This is clearly
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`not what the Board determined. Rather, the Board found that the person of
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`ordinary skill in the art (“POSA”) is one who “would have had familiarity with the
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`biology and pathology of common fungal agents that infect the nail and skin, and a
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`familiarity with antifungal agents and their clinical use.” Paper No. 12, 10.
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`Having “familiarity with antifungal agents and their clinical use” as determined by
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`the Board does not mean that the Board “require[d] experience in specifically
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`treating nail infections” as alleged by PO.
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`Dr. Walters’ deposition and declaration testimony evidences that he not only
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`meets the Board’s definition of a POSA, he was, in fact, a pioneer in studying the
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`permeation of drugs through the skin and nail plate. Ex. 2050, 30:1-33:4, 50:6-13,
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`55:1-20, 58:19-61:17; 68:6-70:20; 79:5-80:3; 90:13-91:11, 98:4-101:9, 161:19-
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`162:3; Ex. 1509, § XIV. Dr. Walters has over four decades of experience in
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`researching and publishing peer-reviewed publications relating specifically to the
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`human nail and antifungal formulations, and has frequently served as a consultant
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`to pharmaceutical companies for the specific purpose of developing and testing
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`dermatological products including topical antifungals for treating onychomycosis.
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`See Walters CV in Ex. 1005. Beginning in the early 1980s, Dr. Walters pioneered
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`the study of permeation characteristics of human nail plate. Ex. 1509, ¶ 128. In
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`fact, many publications authored by Dr. Walters have been relied on in this
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`proceeding by both Petitioners and PO, thereby demonstrating the relevance of his
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`work experience to the field of the patent. See, e.g., Exhibits 1040, 1042, 1043,
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`2019, 2020, 2021, 2083.
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` Dr. Walters has published a clearly on-point book chapter entitled
`“Ungual Formulations: Topical Treatment of Nail Diseases,” filed by PO
`as Ex. 2021. This chapter has a section entitled “In Vivo Investigations”
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`and a section entitled “Clinical Data Supporting Topical Therapy of Nail
`Diseases.” Id., at 348-349. 
` Dr. Walters published another directly relevant book chapter entitled
`“Nail Delivery,” filed by PO as Ex. 2083, containing a section entitled
`“Clinical Data Supporting Topical Therapy of Nail Diseases.” Id., 387.   
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`In addition, Dr. Walters’ publications have been cited in numerous
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`publications authored by others that are also of record in this case, e.g., Exhibits
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`1017, 1020, 1021, 1024, 1030, 2012, 2014, 2015, 2048, 2051, 2057. These
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`publications are only a fraction of the large body of work credited to Dr. Walters
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`over his career. See CV in Ex. 1005. Given the large number of antifungal
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`compounds and formulations that Dr. Walters has researched and published on
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`over the decades, PO’s Daubert challenge is meritless. 37 C.F.R. § 42.12. 
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`Indeed, Dr. Walters’ background is perhaps more pertinent than that of a
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`medical doctor. PO’s expert, 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. Notably, none of the inventors named on the ’506 patent were
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`medical doctors. Ex. 1506 at 10:10-14:14, 33:21-34:3.
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`PO alleges that Dr. Weinberg’s declaration was somehow a tacit admission
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`that Dr. Walters is not qualified. Not true. Dr. Weinberg’s declaration is a proper
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`rebuttal to opinions regarding dermatologists’ medical practices first offered by Dr.
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`Elewski with the filing of the POR - not a response to PO’s baseless criticisms.
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`E. PO’s Motion Is Akin To An Unauthorized Sur-Reply
`“While a motion to exclude may raise issues related to admissibility of
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`Case IPR2017-00190
`Patent 7,214,506 B2
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`evidence, it is not an opportunity to file a sur-reply.” Liberty Mutual Ins. Co.,
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`CBM2012-00002, Paper 66 at 62. PO’s motion crosses the line between arguing
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`the admissibility of evidence and arguing the merits. One blatant example is where
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`PO improperly argues about “specialized treatment of nail infections due to the
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`well-documented unpredictability even in extrapolating from experience treating
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`skin with the same drugs.” Motion, 11. Further, most of pages 10, 11, 14 and the
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`entirety of pages 12 and 13 describe PO’s misleading attempts to narrow the
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`relevant field defined in the Institution Decision, mischaracterizations of Dr.
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`Walters’ testimony, and mischaracterizations of Dr. Walters’ and Dr. Weinberg’s
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`reply declarations. These arguments do not relate in any way to whether
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`Petitioners’ evidence is admissible.
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`For all these reasons, PO’s Motion to Exclude certain portions of Exhibits
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`1005 and 1509 should be denied.
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`Date: January 5, 2018
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`By:
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`Respectfully submitted,
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` /E. Anthony Figg/
`E. Anthony Figg, Reg. No. 27,195
`Counsel for Acrux DDS Pty Ltd
`and Acrux Limited
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`
`
` /Shannon M. Lentz/
`By:
`Shannon M. Lentz, Reg. No. 65,382
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` Counsel for Argentum Pharmaceuticals LLC
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`CERTIFICATE OF SERVICE
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`Case IPR2017-00190
`Patent 7,214,506 B2
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`The undersigned certifies that a copy of the foregoing PETITIONERS’
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`OPPOSITION TO PATENT OWNER’S MOTION TO EXCLUDE UNDER
`37 C.F.R. § 42.64(c) was served electronically via email on January 5, 2018, 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
`
`Teresa Stanek Rea
`TRea@Crowell.com
`Shannon M. Lentz
`SLentz@Crowell.com
`Crowell & Moring LLP
`Intellectual Property Group
`1001 Pennsylvania Ave, NW
`Washington, DC 20004-2595
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`Case IPR2017-00190
`Patent 7,214,506 B2
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`Tyler C. Liu
`TLiu@agpharm.com
`Argentum Pharmaceuticals, LLC
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`/ E. Anthony Figg /_______________
`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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`By:
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` Counsel for Acrux DDS Pty Ltd
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`and Acrux Limited
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`17
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