`
`Paper No. 31
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`________________
`
`FLATWING PHARMACEUTICALS, LLC and
`MYLAN PHARMACEUTICALS, INC.,
`Petitioners,
`
`v.
`
`ANACOR PHARMACEUTICALS, INC.,
`Patent Owner.
`________________
`
`Case No. IPR2018-00168
`(Joined with IPR2018-01358)
`
`U.S. Patent No. 9,549,938
`________________
`
`PETITIONER’S REPLY TO PATENT OWNER’S OPPOSITION
`TO PETITIONER’S MOTION TO EXCLUDE1
`February 15, 2019
`
`
`1 Corresponding replies to Patent Owner’s oppositions filed in related proceedings
`IPR2018-00169 (U.S. Patent No. 9,566,289, joined with IPR2018-01359),
`IPR2018-00170 (U.S. Patent No. 9,566,290, joined with IPR2018-01360), and
`IPR2018-00171 (U.S. Patent No. 9,572,823, joined with IPR2018-001361) are
`substantially the same as this reply, with citations adjusted to cite correctly the
`record in each proceeding.
`
`
`
`
`
`
`
`TABLE OF CONTENTS
`
`Table of Contents ..................................................................................................... i
`
`Table of Authorities ................................................................................................ ii
`
`Discussion .................................................................................................................. 1
`
`Improper Direct Expert Testimony (37 C.F.R. 42.53, FRE 702–703) ......... 3
`
`Hearsay (FRE 801–802) ................................................................................... 4
`
`Improper Impeachment .................................................................................. 4
`
`Authentication (FRE 901) ............................................................................... 5
`
`Conclusion ................................................................................................................. 5
`
`Certificate of Service ................................................................................................ 7
`
`
`
`
`
`– i –
`
`
`
`
`
`TABLE OF AUTHORITIES
`
`CASES
`
`CaptionCall, LLC v. Ultratec, Inc.,
`IPR2013-00540, Paper 80,
`2015 WL 9599187 (P.T.A.B. Dec. 1, 2015) ................................................... 4
`
`Goguen v. Textron, Inc.,
`234 F.R.D. 13 (D. Mass. 2006) ...................................................................... 5
`
`Marvel Characters, Inc. v. Kirby,
`726 F.3d 119 (2d Cir. 2013) ........................................................................... 4
`
`United States v. Starks,
`515 F.2d 112 (3d Cir. 1975) ........................................................................... 5
`
`RULES
`
`FRE 702 ..................................................................................................................... 4
`
`FRE 703 ..................................................................................................................... 4
`
`FRE 801 ..................................................................................................................... 4
`
`FRE 802 ..................................................................................................................... 4
`
`FRE 901 ..................................................................................................................... 5
`
`FRE 902 ..................................................................................................................... 5
`
`REGULATIONS
`
`37 C.F.R. § 42.20 ....................................................................................................... 5
`
`37 C.F.R. § 42.22 ....................................................................................................... 5
`
`37 C.F.R. § 42.53 ....................................................................................................... 4
`
`
`
`– ii –
`
`
`
`
`
`DISCUSSION
`
`Petitioner’s motion (Petitioner’s 37 C.F.R. § 42.64(c) Motion To Exclude,
`
`Paper 27 (hereinafter “Pet. Mot. Excl.”)) identified for every exhibit sought to be
`
`excluded the specific content that Patent Owner offered as hearsay testimony for
`
`the truth of the matter asserted. Patent Owner’s opposition (Paper 29) did not
`
`respond to any of that, but instead merely asserts in conclusory fashion that its
`
`experts “cite to these publications as relevant evidence of the state of the art”
`
`(Patent Owner’s Opposition to Petitioner’s Motion to Exclude 2, Paper 29
`
`(hereinafter “PO Opp.”)), that they are “preexisting documentary evidence” (id. at
`
`2), and that they “go to what a POSA would have known at the time of the
`
`invention” (id. at 4). But patent owner previously admitted that it cited scientific
`
`literature “after the priority date” (Patent Owner’s Response 1, Paper 13
`
`(hereinafter “PO Resp.”)) about alleged “problems with transungual delivery” (id.).
`
`Exhibits 2004, 2005, 2006, 2008, 2015, 2016, 2026, 2028, 2035, and 2036 all
`
`purport to be dated after the asserted 2005 priority date of the patent in suit. They
`
`are not “preexisting documentary evidence” as Patent Owner claims (PO Opp. 2,
`
`Paper 29). They are not prior art disclosures independently operative in defining
`
`the state of the art as of the asserted 2005 priority date. Instead, Patent Owner
`
`relies on them for the truth of the opinions asserted by the authors in those articles,
`
`as identified in Pet. Mot. Excl. and below. Even for the other articles dated before
`
`– 1 –
`
`
`
`
`
`the priority date, Patent Owner did not use them to establish the state of the art but
`
`instead tried to use specific assertions in those articles for the truth of the matters
`
`asserted, as identified in Pet. Mot. Excl. and below.
`
`Patent Owner and its experts repeatedly cite all of the exhibits to be
`
`excluded not for disclosures constituting the state of the art in 2005, but instead as
`
`supposed evidence demonstrating the truth of the matters asserted as opinions of
`
`the authors of those articles. As identified in Pet. Mot. Excl., those matters asserted
`
`include: in Ex. 2004 that the nail is a “formidable barrier”; in Ex. 2005 about the
`
`supposed “inability to deliver a therapeutically effective amount”; in Ex. 2006
`
`about supposed “poor drug diffusion into the highly keratinized nail plate and the
`
`long duration of treatment” (even though tavaborole itself also has a 48-week long
`
`treatment duration (Ex. 1042 at 2)); in Ex. 2007 that “topical therapy continues to
`
`pose a challenge”; in Ex. 2008 about “factors that could limit the accumulation and
`
`activity of drugs in the nail on topical application”; in Ex. 2009 for having been
`
`cited in Ex. 2007 about molecules larger than 300 Daltons facing hindrance in
`
`permeating the nail plate; in Ex. 2015 that VELCADE® was “the only boron-based
`
`therapeutic currently on the market” in 2009; in Ex. 2016 that the “ultimate fate of
`
`all boronic acids in air and aqueous media is their slow oxidation into boric acid”;
`
`in Exs. 2019 & 2020 about the alleged consequences of boron’s ability to form
`
`complexes; in Exs. 2021, 2022, and 2023 about alleged consequences of boron’s
`
`– 2 –
`
`
`
`
`
`“unique” and “promiscuous” properties; in Ex. 2024 that boron compounds were
`
`allegedly known to hydrolyze in the presence of water to form boric acid; in Ex.
`
`2025 about tavaborole’s alleged capability of hydrogen bonding to other molecular
`
`species; in Ex. 2026 about what a POSA would allegedly have thought previously
`
`about boron’s alleged properties; in Ex. 2027 that the “most common form of ony-
`
`chomycosis . . . is characterized by invasion of the nail bed and underside of the
`
`nail plate”; in Ex. 2028 about high binding affinity; in Ex. 2029 about the water
`
`composition of the nail; in Ex. 2030 that “[d]evelopment of topical formulations to
`
`deliver effective amounts of drugs into the nail apparatus is highly challenging”; in
`
`Exs. 2031, 2032, 2033 & 2034 that the penetration of small molecules below 300
`
`Da is allegedly primarily influenced by factors other than molecular weight; in
`
`Ex. 2035 & 2036 that “efinaconazole’s high permeability has been attributed, not
`
`to its molecular weight, but to its low keratin-binding affinity”; in Ex. 2037 that a
`
`compound’s keratin binding affinity “has serious consequences as only the
`
`unbound fraction of an antifungal compound is available to penetrate through the
`
`nail plate”; in Ex. 2038, 2039, & 2040 about hydrolysis of Biobor JF; in Ex. 2041
`
`& 2042 about tavaborole binding with keratin; and in Ex. 2043 about a “super-
`
`structure driven by intermolecular interactions”. (Pet. Mot. Excl. 5–15, Paper 27.)
`
`Improper Direct Testimony—This case is unlike CaptionCall, LLC v.
`
`Ultratec, Inc., IPR2013-00540, Paper 80, 2015 WL 9599187, at *3–4 (P.T.A.B.
`
`– 3 –
`
`
`
`
`
`Dec. 1, 2015), where the parties had stipulated that a transcript be treated as sworn
`
`deposition testimony in a related civil action. Here, as identified above, Patent
`
`Owner seeks to use snippets from alleged articles as substantive, expert opinion
`
`evidence in violation of 37 C.F.R. § 42.53 and FRE 702–703. This situation is also
`
`entirely unlike the cases Patent Owner cites in its footnote, where the proponent
`
`did provide a declaration from the witnesses challenged.
`
`Hearsay—As explained above, the identified evidence is being used not for
`
`the state of the art, but as improper hearsay under FRE 801–802. Although
`
`permitted some leeway to consider facts or data on which “experts in the particular
`
`field would reasonably rely,” FRE 703, expert witnesses cannot act as a mere
`
`conduit for hearsay. E.g., Marvel Characters, Inc. v. Kirby, 726 F.3d 119, 136 (2d
`
`Cir. 2013). Here, Patent Owner did not even elicit any foundational predicate
`
`testimony that the material is the type of information on which experts in the field
`
`ordinarily and customarily rely. Instead, its witnesses merely repeat other authors’
`
`out-of-court writings as evidence of the truth of the matter asserted.
`
`Improper Impeachment—The testimony objected to, including what
`
`Patent Owner cites, is improper impeachment because it is simply not inconsistent.
`
`For example, Dr. Murthy’s previous writing about the “challenge” posed by “poor
`
`permeability” (Ex. 2018 at 74:6–20; Ex. 2007) is not inconsistent with his
`
`testimony (Ex. 1005 ¶ 29) that even if it is challenging, Brehove disclosed that
`
`– 4 –
`
`
`
`
`
`adequate penetration is possible. Dr. Kahl’s direct testimony about “unique
`
`chemical properties of boron” (Ex. 1003 ¶ 31) is not at all inconsistent with the
`
`cross-examination testimony that “Boron is unique . . . .” (Ex. 2017 at 65:14).
`
`Authentication—Although a movant has the burden of proof on a motion,
`
`37 C.F.R. §§ 42.20(c), 42.22, the burden on authentication shifts to the proponent
`
`of the evidence. United States v. Starks, 515 F.2d 112, 122 (3d Cir. 1975) (“If there
`
`is a presumption of regularity it cannot in these circumstances substitute for
`
`evidence or shift to the defendants the burden of disproving authenticity.”). Even if
`
`as Patent Owner argues that burden is “slight”, here Patent Owner did nothing to
`
`meet it. There is no testimony about where these supposed copies came from or
`
`that they are what they purport to be. Patent Owner tangentially cites
`
`FRE 901(b)(4), but proffered no
`
`testimony of such alleged “distinctive”
`
`characteristics and does not even argue that these alleged copied excerpts are self-
`
`authenticating periodicals under 902(6). See Goguen v. Textron, Inc., 234 F.R.D.
`
`13, 18 (D. Mass. 2006) (“A wide variety of publications are published on a regular
`
`schedule . . . . None would be considered ‘periodicals’ in ordinary English us-
`
`age.”). Patent Owner therefore has not met its burden to authenticate these exhibits.
`
`CONCLUSION
`
`Wherefore, Petitioner respectfully requests exclusion of these materials.
`
`
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`– 5 –
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`
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`
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`Dated: February 15, 2019
`
`
`
`
`
` Respectfully submitted,
`
`
`/Philip D. Segrest Jr./
`Philip D. Segrest Jr. (Reg. No. 39,021)
`philip.segrest@huschblackwell.com
`Lead Counsel for Petitioner
`Eric J. Rakestraw (Reg. No. 68,740)
`Eric.Rakestraw@HuschBlackwell.com
`PTAB-ERakestraw@HuschBlackwell.com
`Back-up Counsel for Petitioner
`Edward D. Manzo (Reg. No. 28,139)
`Edward.Manzo@HuschBlackwell.com
`Additional Back-up Counsel for Petitioner
`HUSCH BLACKWELL LLP
`120 South Riverside Plaza, Suite 2200
`Chicago, IL 60606
`Tel. 312-655-1500
`Fax. 312-644-1501
`
`
`
`– 6 –
`
`
`
`
`
`
`
`CERTIFICATE OF SERVICE
`
`The undersigned hereby certifies that a copy of the foregoing document was
`
`served via
`
`electronic mail on
`
`the
`
`following
`
`attorneys of
`
`record:
`
`
`
`Steven Parmelee,
`sparmelee@wsgr.com
`Michael Rosato,
`mrosato@wsgr.com
`Jad Mills
`jmills@wsgr.com
`Counsel for Petitioner Mylan
`Pharms., Inc.
`
`Aaron P. Maurer,
`amaurer@wc.com
`David I. Berl,
`dberl@wc.com
`tselby@wc.com
`asheh@wc.com
`Counsel for Patent Owner
`Anacor Pharms., Inc.
`
`
`
`On this the 15th day of February 2019.
`
`
`
`
`/Philip D. Segrest Jr./
`Philip D. Segrest Jr. (Reg. No. 39,021)
`philip.segrest@huschblackwell.com
`Lead Counsel for Petitioner
`Eric J. Rakestraw (Reg. No. 68,740)
`Eric.Rakestraw@HuschBlackwell.com
`PTAB-ERakestraw@HuschBlackwell.com
`Back-up Counsel for Petitioner
`Edward D. Manzo (Reg. No. 28,139)
`Edward.Manzo@HuschBlackwell.com
`Additional Back-up Counsel for Petitioner
`HUSCH BLACKWELL LLP
`120 South Riverside Plaza, Suite 2200
`Chicago, IL 60606
`Tel. 312-655-1500
`Fax. 312-644-1501
`
`
`
`
`
`
`
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