IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`COALITION FOR AFFORDABLE DRUGS X LLC,
`Petitioner,
`
`ANACOR PHARMACEUTICALS, INC.,
`Patent Owner.
`
`Case No. IPR201 5-01 776
`
`Patent No. 7,5 82,62 1
`
`PATENT OWNER’S OBJECTIONS TO EVIDENCE
`
`UNDER 37 C.F.R. § 42.64(b)(1)
`
`DC: 6157928-3
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`COALITION FOR AFFORDABLE DRUGS X LLC,
`Petitioner,
`
`ANACOR PHARMACEUTICALS, INC.,
`Patent Owner.
`
`Case No. IPR201 5-01 776
`
`Patent No. 7,5 82,62 1
`
`PATENT OWNER’S OBJECTIONS TO EVIDENCE
`
`UNDER 37 C.F.R. § 42.64(b)(1)
`
`DC: 6157928-3
`
`
`
`IPR201 5-01776
`
`Patent Owner, Anacor Pharmaceuticals,
`
`Inc.,
`
`submits
`
`the
`
`following
`
`objections to evidence served by Petitioner, Coalition For Affordable Drugs X
`
`LLC, with its Reply (Paper 47). These objections are timely filed within five (5)
`
`business days from the service date (Aug. 24, 2016) of Petitioner’s Reply.
`
`Exhibit 1051 —- Press Release, Anacor
`
`Exhibit 1051 cited in Petitioner’s Reply is inadmissible for at
`
`least the
`
`following reasons, including under the Federal Rules of Evidence (“FRE”).
`
`Patent Owner objects to Exhibit 1051 as lacking authentication, and thus
`
`inadmissible under FRE 901. Exhibit 1051 purports to be a copy of a 2009 press
`
`release describing prestigious scientific awards received by two of Anacor’s co-
`
`founders. Ex. 1080 11 5. However, Petitioner may not rely on the content of the
`
`website printout without proper authentication. Although the testimony of
`
`Petitioner’s counsel, Ryan James Fletcher, may establish that the exhibit is a true
`
`and correct printout from the identified website, Petitioner has not provided the
`
`testimony of any witness with personal knowledge of the website, and therefore the
`
`exhibit lacks authentication. See Neste Oil OYJ v. Reg Synthetic Fuels, LLC,
`
`IPR20l3—00578, Paper 53 at 341 (P.T.A.B. Mar. 12, 2015).
`
`Patent Owner also objects to Exhibit 1051 as inadmissible hearsay under
`
`FRE 801 and FRE 802, as Exhibit 1051 is not being offered as evidence of what it
`
`describes. Rather, Petitioner offers Exhibit 1051 to prove Dr. Benkovic’s scientific
`
`
`
`IPR2O l 5—Ol776
`
`views about boron-containing compounds in 2002, relying on a quote from a
`
`different person in 2009. See Reply (Paper 47) p. 5.
`
`Patent Owner further objects to Exhibit 1051 as being inadmissible under
`
`FRE 402 as lacking relevance.
`
`Exhibit 1067 —— ASTM® D5134 Qualitative Reference Naphtha Standard
`
`Exhibit 1067 is inadmissible for at least the following reasons, including
`
`under the Federal Rules of Evidence (“FRE”).
`
`Patent Owner objects to Exhibit 1067 as lacking authentication, and thus
`
`inadmissible under FRE 901. Exhibit 1067 purports to be a printout of an online
`
`Safety Data Sheet from a chemical supply company’s website. Ex. 1080 1] 9.
`
`However, Petitioner may not rely on the content of the website printout without
`
`proper authentication. Although the testimony of Petitioner’s counsel, Ryan James
`
`Fletcher, may establish that the exhibit is a true and correct printout from the
`
`identified website, Petitioner has not provided the testimony of any witness with
`
`personal knowledge of the website, and therefore the exhibit lacks authentication.
`
`See Neste Oil OYJ v. Reg Synthetic Fuels, LLC, IPR20l3-00578, Paper 53 at 3—4
`
`(P.T.A.B. Mar. 12, 2015).
`
`Patent Owner further objects to Exhibit 1067 as being inadmissible under
`
`FRE 402 as lacking relevance because the Exhibit is not prior art. Exhibit 1067
`
`states that it was revised in 2015. Ex. 1067 p. 1. Petitioner, however, cites Exhibit
`
`
`
`IPR20 1 5-01776
`
`1067 to suggest that a POSA in 2005 would have attributed any overlapping
`
`toxicity between naphtha and Biobor JF® to the naphtha component of Biobor JF®,
`
`and not to the active dioxaborinane ingredients. See Reply (Paper 47) p. 22.
`
`Exhibit 1068 — Tavaborole, Material Safety Data Sheet
`
`Exhibit 1068 is inadmissible for at least the following reasons, including
`
`under the Federal Rules of Evidence (“FRE”).
`
`Patent Owner objects to Exhibit 1068 as lacking authentication, and thus
`
`inadmissible under FRE 901. Exhibit 1068 purports to be a printout of an online
`
`Material Safety Data Sheet from a chemical supply company’s website. Ex. 1080
`
`11 10. However, Petitioner may not rely on the content of the website printout
`
`without proper authentication. Although the testimony of Petitioner’s counsel,
`
`Ryan James Fletcher, may establish that the exhibit is a true and correct printout
`
`from the identified website, Petitioner has not provided the testimony of any
`
`witness with personal knowledge of the website, and therefore the exhibit lacks
`
`authentication. See Neste Oil OYJ v. Reg Synthetic Fuels, LLC, IPR20l3—00578,
`
`Paper 53 at 3-4 (P.T.A.B. Mar. 12, 2015).
`
`Patent Owner further objects to Exhibit 1068 as being inadmissible under
`
`FRE 402 as lacking relevance because the Exhibit is not prior art. Exhibit 1068
`
`states, “Date: 08.19.2016.” Ex. 1068 p. 1. Petitioner, however, cites Exhibit 1068
`
`to suggest that a POSA in 2005 would not have been dissuaded from topically
`
`
`
`IPR20l 5—01776
`
`applying the compounds of BioborJF®, despite strong warnings in the MSDS that
`
`the product causes severe skin irritation, in part because the MSDS of tavaborole
`
`(i. e., Exhibit 1068) lists similar warnings. See Reply (Paper 47) p. 22.
`
`Exhibits 1069 & 1071 — FDA Approval Packages
`
`Exhibits 1069 (“Approval Package for Jublia”) and 1071 (“Approval
`
`Package for Kerydin”) are inadmissible for at
`
`least
`
`the following reasons,
`
`including under the Federal Rules of Evidence (“FRE”).
`
`Patent Owner objects to Exhibits 1069 and 1071 as lacking authentication,
`
`and thus inadmissible under FRE 901. Both Exhibits purport to be printouts from
`
`an FDA website. Ex. (1080 W ll & 13. However, Petitioner may not rely on the
`
`content of the website printouts without proper authentication. Although the
`
`testimony of Petitioner’s counsel, Ryan James Fletcher, may establish that the
`
`exhibits are true and correct printouts from the identified website, Petitioner has
`
`not provided the testimony of any witness with personal knowledge of the website,
`
`and therefore the exhibit lacks authentication. See Neste Oil OYJ v. Reg Synthetic
`
`Fuels, LLC, IPR2013-00578, Paper 53 at 3-4 (P.T.A.B. Mar. 12, 2015).
`
`Patent Owner
`
`further objects
`
`to Exhibits 1069 and 1071
`
`as being
`
`inadmissible under FRE 402 as lacking relevance because neither Exhibit is prior
`
`art. Both Exhibits expressly list dates in 2014. Ex. 1069 p. 8; Ex. 1071 p. 9.
`
`Petitioner, however, cites Exhibits 1069 and 1071 to suggest that there was not a
`
`
`
`IPR20 1 5-0 l 776
`
`long-felt need for a safe and effective topical onychomycosis treatment. See Reply
`
`(Paper 47) pp. 23-24. Thus, Exhibits 1069 and 1071 are irrelevant because long-
`
`felt need must be judged as of the priority date. See Procter & Gamble Ca. V. Teva
`
`Pharms. USA, Inc, 566 F.3d 989, 998 (Fed. Cir. 2009) (rejecting the challenger’s
`
`argument that long—felt need should be judged “at the time the invention becomes
`
`available on the market”).
`
`Exhibit 1074 ——Roger Henriksson et al., Boron Neutron Capture
`
`Exhibit 1074 is inadmissible for at least the following reasons, including
`
`under the Federal Rules of Evidence (“FRE”).
`
`Patent Owner objects to Exhibit 1074 as being inadmissible under FRE 402
`
`as lacking relevance because the Exhibit
`
`is not prior art. Exhibit 1074 was
`
`published in 2008. See Ex. 1074 p. l. Petitioner’s expert, however, cites Exhibit
`
`1074 to suggest that a POSA in 2005 would have known that a sulfliydryl borane
`
`anion can be administered at a high dose to a human without significant toxicity.
`
`See Ex. 1043 (KahlDecl.)1l 16.
`
`Exhibit 1075 —- Poster Presentation, A.S. Kushwaha et (11.
`
`Exhibit 1075 is inadmissible as used by Petitioner for at least the following
`
`reasons, including under the Federal Rules of Evidence (“FRE”).
`
`Patent Owner objects to Exhibit 1075 as being inadmissible under FRE 402
`
`as lacking relevance because the Exhibit is not prior art. Exhibit 1075 contains no
`
`
`
`IPR2015-01776
`
`date, but Petitioner’s expert Dr. Murthy suggests that the Exhibit was published in
`
`2015. See Ex. 2032 (Murthy Depo.) at 77:15—78:8. Moreover, Petitioner and its
`
`expert do not even indicate the journal in which Ex. 1075 was published. Dr.
`
`Murthy, however, cites Exhibit 1075 to suggest that a POSA would have had a
`
`reasonable expectation of success in 2005. See Ex. 1044 (Murthy Dec1.)‘ll 80.
`
`Date: August3l,2016
`
`Respectfully submitted,
`
`,
`Byi,» 5?”;/25:4
`Andrea G. Reistep
`
`, 2‘
`2
`
`,
`
`Registration No. 36,253
`
`COVINGTON & BURLING LLP
`
`One CityCenter, 850 Tenth Street, NW
`
`Washington, DC 20001
`
`(202) 662-6000
`
`Attorneys for Patent Owner
`
`
`
`CERTIFICATE OF SERVICE
`
`Pursuant to 37 C.F.R. § 42.6, I hereby certify that on this 31st day of August
`
`2016,
`
`the foregoing Patent Owner’s Objections to Evidence under 37 C.F.R.
`
`§42.64(b)(1) was served by electronic mail, by agreement of the parties, on the
`
`following counsel of record for petitioner.
`
`Jeffrey D. Blake
`Kathleen E. Ott
`
`Peter A. Gergely
`Ryan James Fletcher
`Brent E. Routman
`
`Merchant & Gould PC
`
`KerydinIPR@merchantgould.com
`
`Date: August 31, 2016
`
`f
`
`g}? V‘
`
`‘X, .3
`C!X«/?”'3~/”§’[/1»»»~
`Andrea G. Reister, Esq.
`Registration No: 36,253
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