UNITED STATES PATENT AND TRADEMARK OFFICE
`__________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`__________________
`
`FLATWING PHARMACEUTICALS, LLC and
`MYLAN PHARMACEUTICALS INC.,
`Petitioners,
`
`v.
`
`ANACOR PHAMACEUTICALS, INC.,
`Patent Owner.
`__________________
`
`Case No. IPR2018-001681
`U.S. Patent No. 9,549,938
`__________________
`
`PATENT OWNER’S OPPOSITION TO
`PETITIONER’S MOTION TO EXCLUDE
`
`
`
`
`
`1 Case No. IPR2018-01358 has been joined with this proceeding
`
`1
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`

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`Case No. IPR2018-00168
`U.S. Patent No. 9,549,938
`
`
`TABLE OF CONTENTS
`
`ARGUMENT ............................................................................................................. 2
`
`I.
`
`The Challenged Exhibits Are Not “Uncompelled Direct Testimony” ............ 2
`
`II.
`
`FlatWing’s Hearsay Objections Are Without Merit ........................................ 4
`
`III.
`
`FlatWing’s “Improper Impeachment” Objections Are Baseless ..................... 6
`
`IV. Anacor’s Exhibits Have Been Properly Authenticated ................................... 6
`
`CONCLUSION .......................................................................................................... 9
`
`
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`Case No. IPR2018-00168
`U.S. Patent No. 9,549,938
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`TABLE OF AUTHORITIES
`
`
`Cases:
`
`Page(s):
`
`Apotex Inc. v. Novartis AG, IPR2017-00854, Paper 109, 2018 WL
`3414289, (P.T.A.B. July 11, 2018) ....................................................................... 6
`
`Argentum Pharm. LLC v. Research Corp. Techs., Inc., IPR2016-
`00204, Paper 85, 2017 WL 1096590 (P.T.A.B. Mar. 22, 2017) .......................... 5
`
`AVX Corp. v. Greatbatch, Ltd., IPR2014-00697, Paper 57 (P.T.A.B.
`Oct. 21, 2015) ....................................................................................................... 3
`
`CaptionCall, LLC v. Ultratec, Inc., IPR2013-00540, Paper 80, 2015
`WL 9599187 (P.T.A.B. Dec. 1, 2015) .............................................................. 2, 3
`
`Coalition for Affordable Drugs X LLC v. Anacor Pharm., Inc.,
`IPR2015-01776 ..................................................................................................... 8
`
`Kaz USA, Inc. v. Exergen Corp., IPR2016-01437, Paper 43, 2017 WL
`6551238 (P.T.A.B. Dec. 22, 2017) ....................................................................... 6
`
`LG Chem. Ltd. v. Celgard, LLC, IPR2014-00692, Paper 76, 2015 WL
`5896170 (P.T.A.B. Oct. 5, 2015) .......................................................................... 5
`
`MindGeek, s.a.r.l. v. Skky Inc., IPR2014-01236, Paper No. 45
`(P.T.A.B. Jan. 29, 2016) ....................................................................................... 3
`
`Primera Tech., Inc. v. Automatic Mfg. Sys., Inc., IPR2013-00196,
`Paper 50 (P.T.A.B. July 17, 2014) ........................................................................ 3
`
`SDI Techs., Inc. v. Bose Corp., IPR2013-00465, Paper 40, 2014 WL
`5841551 (P.T.A.B. Nov. 7, 2014) ................................................................. 7, 8, 9
`
`SK Innovation Co. v. Celgard, LLC, IPR2014-00679, Paper 58, 2015
`WL 5722450 (P.T.A.B. Sept. 25, 2015) ............................................................... 5
`
`Rules:
`
`Page(s):
`
`Fed. R. Evid. 702 .................................................................................................. 2, 3
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`ii
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`Case No. IPR2018-00168
`U.S. Patent No. 9,549,938
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`Fed. R. Evid. 703 .................................................................................................. 2, 5
`
`Fed. R. Evid. 801 ...................................................................................................... 2
`
`Fed. R. Evid. 802 ...................................................................................................... 2
`
`Fed. R. Evid. 901 ...................................................................................................... 2
`
`Regulations:
`
`Page(s):
`
`37 C.F.R. § 42.53 ................................................................................................... 2, 3
`
`37 C.F.R. § 42.65 ....................................................................................................... 3
`
`
`
`
`
`iii
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`Case No. IPR2018-00168
`U.S. Patent No. 9,549,938
`
`
`The exhibits Anacor has filed this proceeding are the type of scientific
`
`articles and publications that the Board regularly admits into evidence. Nothing in
`
`these documents comes close to suggesting that they are anything other than what
`
`they purport to be: the publicly available and peer-reviewed writings of
`
`practitioners in the fields of transungual drug delivery and boron chemistry.
`
`Anacor’s experts, Dr. Lane and Dr. Reider, have cited to these documents as
`
`evidence supporting their opinions, including what the person of ordinary skill in
`
`the art (“POSA”) would have known at the time the invention was made. There is
`
`nothing untoward about the manner in which Anacor and its experts have relied on
`
`the documentary evidence in this case.
`
`In response to Anacor’s documentary evidence, FlatWing has raised a host
`
`of form boilerplate objections that are without basis in law or fact. FlatWing
`
`tellingly cites no authority to support its twisted application of the Federal Rules of
`
`Evidence (“FRE”) and the rules of evidentiary procedure before the Board. This is
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`not surprising because the case law is to the contrary. FlatWing further fails to
`
`engage meaningfully with the record, including the self-authenticating indicia
`
`present throughout Anacor’s exhibits, as well the portions of the record that
`
`expressly lay foundation and establish the authenticity of Anacor’s cited evidence.
`
`FlatWing’s motion to exclude (Paper 27, “Mot.”) should be denied.
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`1
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`Case No. IPR2018-00168
`U.S. Patent No. 9,549,938
`
`
`ARGUMENT
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`FlatWing contends that Anacor’s exhibits (or portions thereof) should be
`
`excluded on four overarching, independent bases: improper direct expert testimony
`
`under 37 C.F.R. § 42.53 and FRE 702–03, hearsay under FRE 801–02, improper
`
`impeachment, and lack of authentication under FRE 901. Each is without merit.
`
`I.
`
`The Challenged Exhibits Are Not “Uncompelled Direct Testimony”
`
`FlatWing’s contention that Anacor’s citations and quotations from scientific
`
`publications amount to “uncompelled direct testimony” under 37 C.F.R. § 42.53,
`
`Mot. at 3, is founded on the perplexing notion that the authors of the publications
`
`or the publications themselves are somehow “testifying” in these proceedings on
`
`Anacor’s behalf. That is not the case. The authors are not witnesses or persons
`
`under Anacor’s control, and their “testimony” was not elicited by Anacor. Anacor
`
`(and its experts) simply cite to these publications as relevant evidence of the state
`
`of the art. Excluding the exhibits on this basis would render 37 C.F.R. § 42.53 a
`
`nearly insurmountable hurdle to the admission of preexisting documentary
`
`evidence, an absurd result.
`
`FlatWing’s position contravenes the Board’s previous holding that “Rule
`
`42.53 . . . applies only to testimony taken ‘during a testimony period set by the
`
`Board’ for the purposes of a particular review proceeding.” CaptionCall, LLC v.
`
`Ultratec, Inc., IPR2013-00540, Paper 80, 2015 WL 9599187, at *3–4 (P.T.A.B.
`
`2
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`Dec. 1, 2015). CaptionCall is particularly instructive because the evidence at
`
`issue, a videotaped interview, was “treated as sworn deposition testimony in [a
`
`related] district court proceeding” between the parties to the IPR, yet the Board
`
`rejected the argument the evidence ran afoul the rule. Id. The scientific articles
`
`and publications cited by Anacor as exhibits are even less “testimonial” than the
`
`evidence in CaptionCall and all predate these proceedings. As such, they are
`
`neither “testimony taken ‘during a testimony period set by the Board’” nor
`
`testimony prepared “for the purposes of a particular review proceeding.” Id.
`
`FlatWing’s objections under Rule 45.53 are should be rejected.2
`
`
`2 FlatWing’s subsidiary objections that Anacor’s exhibits “are in the nature of”
`
`improper expert testimony fail a fortiori because the exhibits are not “uncompelled
`
`direct testimony” under 37 C.F.R. § 42.53. At all events, under the Board’s cases,
`
`FlatWing’s objections under FRE 702 and 37 C.F.R. § 42.65, see Mot. at 3–4, go
`
`to the weight of Anacor’s exhibits, not their admissibility. See, e.g., MindGeek,
`
`s.a.r.l. v. Skky Inc., IPR2014-01236, Paper No. 45 at 23 (P.T.A.B. Jan. 29, 2016);
`
`AVX Corp. v. Greatbatch, Ltd., IPR2014-00697, Paper 57 at 26 (P.T.A.B. Oct. 21,
`
`2015); Primera Tech., Inc. v. Automatic Mfg. Sys., Inc., IPR2013-00196, Paper 50
`
`at 26–30 (P.T.A.B. July 17, 2014).
`
`3
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`Case No. IPR2018-00168
`U.S. Patent No. 9,549,938
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`II.
`
`FlatWing’s Hearsay Objections Are Without Merit
`
`FlatWing’s hearsay objections mischaracterize how Anacor has deployed its
`
`documentary evidence. As FlatWing concedes, “[b]ooks, treatises, journal articles,
`
`and other non-patent literature” are regularly cited “on issues such as anticipation,
`
`obviousness, the scope and content of the prior art, or secondary considerations
`
`like teaching away. When used in that manner, the articles are [not] offered for
`
`the truth of the matter asserted . . . . The mere fact of the disclosure in such
`
`publications is itself legally relevant.” Mot. at 2–3 (emphasis added). That is
`
`precisely how Anacor has relied on the record in this case: Anacor’s exhibits go to
`
`what a POSA would have known at the time of the invention, and Dr. Lane and Dr.
`
`Reider have cited to them for this non-hearsay purpose. See, e.g. Lane Decl. (Ex.
`
`2014) ¶ 55 n.3 (“[I]t was well-established in the art . . . that topical treatments for
`
`onychomycosis have yet to achieve adequate nail penetration.” (discussing Exs.
`
`2004, 2005, 2007, 2008, 2030)); Reider Decl. (Ex. 2013) ¶ 69 (“Brehove may have
`
`formulated . . . Biobor JF for topical application, but did so ignorant of the
`
`decomposition of Biobor JF’s active ingredient through hydrolysis to boric acid—a
`
`fact known to a POSA in 2005.” (discussing Exs. 2022, 2038, 2039, 2040)).
`
`FlatWing thus faults Anacor even as it seeks to rely on the same type of evidence
`
`for the same non-hearsay purposes. There is simply no merit to FlatWing’s
`
`hearsay objections.
`
`4
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`In any event, experts are permitted to rely on hearsay evidence in forming
`
`their opinions, and FlatWing brings no challenge in this regard to Anacor’s
`
`exhibits or their use by Dr. Lane and Dr. Reider. See FRE 703 (“If experts in the
`
`particular field would reasonably rely on those kinds of facts or data in forming an
`
`opinion on the subject, they need not be admissible for the opinion to be
`
`admitted.”). Moreover, “FRE 703 allows the proponent of the expert opinion to
`
`disclose the evidence underlying an expert opinion . . . if the ‘probative value in
`
`helping the [factfinder] evaluate the opinion substantially outweighs [its]
`
`prejudicial effect.’” LG Chem. Ltd. v. Celgard, LLC, IPR2014-00692, Paper 76,
`
`2015 WL 5896170, at *26 (P.T.A.B. Oct. 5, 2015). FlatWing’s motion fails to
`
`identify any prejudice that would ensue from the Board’s review of the exhibits
`
`relied upon by Dr. Lane and Dr. Reider. There is none, and “because the Board is
`
`not a lay jury, and has significant experience in evaluating expert testimony, the
`
`danger of prejudice in this proceeding is considerably lower than in a conventional
`
`district court trial.” SK Innovation Co. v. Celgard, LLC, IPR2014-00679, Paper
`
`58, 2015 WL 5722450, at *29–30 (P.T.A.B. Sept. 25, 2015). Indeed, “the ability
`
`to evaluate the document[s] underlying Dr. [Lane and Dr. Reider’s] testimony
`
`outweighs any prejudicial effect” that FlatWing could possibly hope to identify.
`
`Argentum Pharm. LLC v. Research Corp. Techs., Inc., IPR2016-00204, Paper 85,
`
`2017 WL 1096590, at *24–25 (P.T.A.B. Mar. 22, 2017).
`
`5
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`Case No. IPR2018-00168
`U.S. Patent No. 9,549,938
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`III. FlatWing’s “Improper Impeachment” Objections Are Baseless
`
`FlatWing’s oblique references to the deposition transcripts of its declarants,
`
`Dr. Murthy and Dr. Kahl, fail to preserve its objections to Anacor’s cross-
`
`examinations, including on the ground of improper impeachment. See Mot. 5–15.
`
`Nevertheless, to the extent that FlatWing’s motion is deemed to have preserved its
`
`objections, there is still no basis to exclude Anacor’s cross-examination. The
`
`cross-examinations of Dr. Murthy (Ex. 2018 and Ex. 2046) and Dr. Kahl (Ex. 2017
`
`and Ex. 2047) contain testimony highly relevant to their opinions, including Dr.
`
`Murthy’s opinion disagreeing with the proposition that “anti-fungal drugs cannot
`
`readily pierce the nail plate,” Ex. 1005 ¶ 29, despite his numerous prior statements
`
`to the contrary, see, e.g., Ex. 2017 at 58:5–11 (quoting from Ex. 2007 at 302–03),
`
`and Dr. Kahl’s opinion regarding the “unique” properties of boron, compare Ex.
`
`1003 ¶ 31, with Ex. 2017 at 65:9–66:5. That is “sufficient reason” to admit their
`
`cross-examination testimony and the exhibits used therein in their entirety, as the
`
`Board has previously held. See Apotex Inc. v. Novartis AG, IPR2017-00854, Paper
`
`109, 2018 WL 3414289, at *22 (P.T.A.B. July 11, 2018) (admitting testimony and
`
`exhibits “introduced to test” declarants opinion regarding dosage calculations).
`
`IV. Anacor’s Exhibits Have Been Properly Authenticated
`
`The Board has recognized that “the burden of proof for authentication is
`
`‘slight,’” Kaz USA, Inc. v. Exergen Corp., IPR2016-01437, Paper 43, 2017 WL
`
`6
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`6551238, at *4 (P.T.A.B. Dec. 22, 2017) (quoting Lexington Ins. Co. v. Western
`
`Pennsylvania Hosp., 423 F.3d 318, 329 (3d Cir. 2005)), and that “‘[t]he
`
`appearance, contents, substance, internal patterns or other distinctive
`
`characteristics of the item, taken together with all the circumstances’ is evidence
`
`that may satisfy the authentication requirement,” SDI Techs., Inc. v. Bose Corp.,
`
`IPR2013-00465, Paper 40, 2014 WL 5841551, at *7 (P.T.A.B. Nov. 7, 2014)
`
`(quoting FRE 901(b)(4)).
`
`Exhibits 2004, 2005, 2006, 2007, 2008, 2009, 2015, 2016, 2017, 2019,
`
`2020, 2021, 2022, 2023, 2024, 2025, 2026, 2027, 2028, 2029, 2030, 2031, 2032,
`
`2033, 2034, 2035, 2036, 2037, 2039, 2040, 2041, 2042, and 2043 are journal
`
`articles, books, or book chapters from respected scientific publishers and are
`
`authenticated by their “appearance, contents, substance, internal patterns or other
`
`distinctive characteristics,” including: the nature of their contents including listings
`
`of references cited; the name of the journal; the volume, issue, and year of
`
`publication; the authors’ affiliations and correspondence address; the date the
`
`manuscript was received and accepted for publication; document object identifier
`
`(DOI) numbers and other indexing information; and logos, seals, trademarks, and
`
`copyright information belonging to the publisher. In certain cases, additional
`
`information such as the date the article was downloaded from the publisher’s
`
`website, the journal’s cover and a table of contents are also provided. Exhibit
`
`7
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`2038 is a service bulletin for Biobor JF from Hammonds Fuel Additives, Inc.
`
`bearing manufacturer’s logos, trademarks, and contact information, and was
`
`previously admitted in Coalition for Affordable Drugs X LLC v. Anacor Pharm.,
`
`Inc., IPR2015-01776, Ex. 2154 (P.T.A.B. June 6, 2016).3 The discussion and
`
`references to all of Anacor’s exhibits in the declarations of Dr. Lane (Ex. 2014)
`
`and Dr. Reider (Ex. 2013) are further evidence of their authenticity. Moreover,
`
`Exhibits 2004, 2005, 2006, 2007, 2008, and 2009, 2030, and 2038 were
`
`authenticated by FlatWing’s experts in their depositions. See Murthy Dep. (Ex.
`
`2018) at 79:12–80:22, 63:6–23, 69:10–16, 36:10–38:6, 43:24–44:18, 49:16–51:3
`
`(authenticating and confirming Dr. Murthy as a coauthor of Exs. 2004–2009); Kahl
`
`Reply Dep. (Ex. 2047) at 30:23–31:18 (authenticating Ex. 2038); Murthy Reply
`
`Dep. (Ex. 2046) at 64:19–65:11 (authenticating Ex. 2030).
`
`Under these circumstances, Anacor’s exhibits easily satisfy the low
`
`threshold for authentication, while FlatWing has failed to “articulate anything
`
`about the document[s] that would indicate [their] unreliability.” SDI Techs., 2014
`
`
`3 Exhibits 2007, 2008, 2015, 2024, 2025, 2027, 2029, 2030, 2031, 2032, 2033,
`
`2034, 2037, and 2043 were also admitted as Exhibits 2040, 2195, 1056, 2117,
`
`2018, 2070, 2191, 2041, 2188, 1076, 2192, 2194, 2021, and 2189 in IPR2015-
`
`01776, respectively.
`
`8
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`Case No. IPR2018-00168
`U.S. Patent No. 9,549,938
`
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`WL 5841551, at *7. FlatWing has accordingly failed to carry the burden on its
`
`motion to exclude. Id. There is no real dispute that Anacor’s exhibits are precisely
`
`what they appear to be.
`
`CONCLUSION
`
`For the foregoing reasons, FlatWing’s motion to exclude should be denied.
`
`
`Date: February 8, 2019
`
`
`
`
`
`
`
` Respectfully submitted,
`
`/s/ Aaron P. Maurer
`Aaron P. Maurer (Reg. No. 44,911)
`David I. Berl (Reg. No. 72,751)
`Anthony H. Sheh (Reg. No. 70,576)
`WILLIAMS & CONNOLLY LLP
`725 Twelfth Street, N.W.
`Washington, DC 20005
`T: (202) 434-5000
`F: (202) 434-5029
`amaurer@wc.com
`dberl@wc.com
`asheh@wc.com
`
`Counsel for Patent Owner Anacor
`Pharmaceuticals, Inc.
`
`9
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`Case No. IPR2018-00168
`U.S. Patent No. 9,549,938
`
`
` CERTIFICATE OF SERVICE (37 C.F.R. § 42.6(e))
`
`
`
`The undersigned hereby certifies that a true and correct copy of the
`
`foregoing was served on February 8, 2019, by delivering a copy via electronic mail
`
`on the following attorneys of record for Petitioners:
`
`Philip D. Segrest, Jr.
`Eric J. Rakestraw
`Edward D. Manzo
`HUSCH BLACKWELL LLP
`120 South Riverside Plaza, Suite 2200
`Chicago, Illinois 60606
`Philip.Segrest@HuschBlackwell.com
`Eric.Rakestraw@HuschBlackwell.com
`PTAB-ERakestraw@HuschBlackwell.com
`Edward.Manzo@HuschBlackwell.com
`
`Counsel for Petitioner FlatWing Pharmaceuticals, LLC
`
`Steven W. Parmelee
`Michael T. Rosato
`Jad A. Mills
`WILSON SONSINI GOODRICH & ROSATI
`701 Fifth Avenue, Suite 5100
`Seattle, WA 98104-7036
`sparmelee@wsgr.com
`mrosato@wsgr.com
`jmills@wsgr.com
`
`Counsel for Petitioner Mylan Pharmaceuticals Inc.
`
`
`
`
`
`/Anthony H. Sheh/
`Anthony H. Sheh
`Reg. No. 70,576
`
`
`
`
`10
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`