IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`COALITION FOR AFFORDABLE DRUGS X LLC,
`Petitioner,
`
`v.
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`ANACOR PHARMACEUTICALS, INC.,
`Patent Owner.
`
`Case No. IPR2015-01776
`Patent No. 7,582,621
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`PATENT OWNER’S REPLY TO PETITIONER’S RESPONSE TO
`MOTION TO EXCLUDE EVIDENCE PURSUANT TO 37 C.F.R. § 42.64
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` DC: 6209771-5
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`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`COALITION FOR AFFORDABLE DRUGS X LLC,
`Petitioner,
`
`v.
`
`ANACOR PHARMACEUTICALS, INC.,
`Patent Owner.
`
`Case No. IPR2015-01776
`Patent No. 7,582,621
`
`PATENT OWNER’S REPLY TO PETITIONER’S RESPONSE TO
`MOTION TO EXCLUDE EVIDENCE PURSUANT TO 37 C.F.R. § 42.64
`
`
`
`
`
`
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`
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` DC: 6209771-5
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`I.
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`Introduction
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`
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`IPR2015-01776
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`Patent Owner Anacor Pharmaceuticals, Inc. submits this reply to Petitioner’s
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`Response to Patent Owner’s Motion to Exclude Evidence (Paper No. 63), filed on
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`October 11, 2016.
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`II. Argument
`A. Exhibits 1024, 1025, 1031, 1032, 1051, 1067, 1068, 1069, and 1071
`should be excluded under FRE 901 due to a
`lack of
`authentication.
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`Petitioner has not submitted any evidence establishing that Exhibits 1024,
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`1025, 1031, 1032, 1051, 1067, 1068, 1069, and 1071 are admissible. Petitioner has
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`still not provided the testimony of any witness with personal knowledge of the
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`websites listed in Exhibits 1024, 1025, 1031, 1032, 1051, 1067, 1068, 1069 and
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`1071, and has not provided any other basis for concluding that the webpages are
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`authentic or to establish their dates of publication. See EMC Corp. v. PersonalWeb
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`Techs., LLC, IPR2013-00084, Paper No. 64, p. 45-46 (citations omitted).
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`Petitioner’s supplemental evidence is merely testimony of its counsel in
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`Exhibits 1036 and 1080. With regard to Exhibit 1025, Petitioner asserts that its
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`newly filed Exhibit 1038, a certified copy of a section of the Brehove prosecution
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`history containing a purported copy of Biobor JF® MSDS indicating an effective
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`date of 2000, is self-authenticating. Petitioner maintains that the MSDS of Exhibit
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`1038 “is the same as Exhibit 1025 with the exception of the publication date.”
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`Paper No. 63 at 6. However, the MSDS copy contained in Exhibit 1038 is not the
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`1
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`IPR2015-01776
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`same MSDS document previously filed as Exhibit 1025. In addition to indicating a
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`different effective date, Exhibit 1038 provides a different approximate weight
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`percent for dioxaborinanes. See Exhibit 1038 at 10; Exhibit 1025 at 1. Further,
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`newly filed Exhibits 1040 and 1041 fail to cure the deficiency in Exhibits 1031 and
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`1032, as they also do not indicate their respective online publication dates.
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`Petitioner has submitted no authentication from the websites themselves and has
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`not attempted to establish any online publication date.
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`Thus, Exhibits 1024, 1025, 1031, 1032, 1051, 1067, 1068, 1069, and 1071
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`lack authentication and are inadmissible under FRE 901.1
`
`B.
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`Exhibits 1024, 1025, 1031, 1032, and 1051 should be excluded
`under FRE 801 and FRE 802 as inadmissible hearsay.
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`Exhibits 1024, 1025, 1031, 1032, and 1051 are also inadmissible hearsay
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`under FRE 801 and FRE 802 because they are offered as evidence of what they
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`assert. Regarding Exhibit 1024, Petitioner points to Exhibit 2006 but provides no
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`rationale or evidence showing how Exhibit 2006 could verify the truth of unknown
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`webpage contents with uncertain date. Petitioner has also not established that
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`1 Petitioner asserts that Patent Owner has not objected to Exhibits 1024, 1025,
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`1067, and 1068 in the related IPR2015-01785 proceeding. The point is of no
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`moment. Exhibits 1024, 1025, 1067, and 1068 pertain to the rejection ground
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`involving Brehove, which is not in the IPR2015-01785 rejection grounds.
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`2
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`IPR2015-01776
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`Exhibits 1024, 1025, 1031, and 1032 fall within the hearsay exception of FRE
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`803(17) because Petitioner provides no evidence that the Exhibits are “generally
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`relied on” as market reports or similar commercial publications. Fed. R. Evid.
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`803(17). Further, Petitioner has not established that the contents of Exhibit 1051
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`constitute an opposing party’s statement. Petitioner does not even attempt to
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`address how David Perry’s statement about Dr. Benkovic’s views would not
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`constitute hearsay under FRE 801(d)(2)(A).
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`Accordingly, Exhibits 1024, 1025, 1031, 1032, and 1051 should also be
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`excluded as inadmissible hearsay.
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`C. Exhibits 1031 and 1032 should be excluded as lacking relevance
`under FRE 402 and lacking probative value under FRE 403.
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`Petitioner argues that Exhibits 1031 and 1032 pertain to long-felt need and
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`Patent Owner’s Exhibit 2063, but the Exhibits are in fact cited for the assertion that
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`“[t]he public has a significant interest in ensuring monopoly privileges are not
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`granted by an invalid patent where, as here, Kerydin® can cost up to $500.00 per
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`month per patient.” Petition p. 21. As set forth in the Motion to Exclude, this
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`issue is separate and apart from the three grounds raised in the Petition.
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`Consequently, both Exhibits should be excluded on relevance grounds.
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`Exhibit 1032 is also inadmissible as lacking probative value under FRE 403.
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`Petitioner does not address how its limited, cherry-picked pricing data are
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`sufficient to prove or demonstrate Kerydin® prices generally. Exhibit 1032 should
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`3
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`IPR2015-01776
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`therefore be excluded under FRE 403.
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`D. Exhibits 1067, 1068, 1069, 1071, 1074, and 1075 should be
`excluded as lacking relevance.
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`Exhibits 1067, 1068, 1069, 1071, 1074, and 1075 are inadmissible as lacking
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`relevance because they are not prior art. Petitioner does not address how these
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`documents, with alleged publication dates that are significantly later than the
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`priority date, are relevant to a POSA’s knowledge in 2005. In attempting to
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`respond to the relevance objections, Petitioner cites Mylan Pharms. v. Yeda Res. &
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`Dev. Co., IPR2015-00644, Paper 86 at 34 (“A post-filing date publication is not
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`automatically excluded from consideration as irrelevant.”). However, Mylan is
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`inapplicable to the instant grounds for exclusion because the publication at issue
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`was published three weeks after the priority date and described a study that began
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`two years prior. See id. And Petitioner does not even attempt to address how these
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`documents, with purportedly much later publication dates, could have contributed
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`to a POSA’s knowledge in 2005.
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`Additionally, with respect to Exhibit 1069 and Exhibit 1071, as set forth in
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`Patent Owner’s Motion to Exclude, long-felt need must be judged as of the priority
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`date. See Procter & Gamble Co. v. Teva Pharms. USA, Inc., 566 F.3d 989, 998
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`(Fed. Cir. 2009). Petitioner does not even attempt to address how Exhibit 1069
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`and Exhibit 1071 are relevant to long-felt need.
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`4
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`
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`Accordingly, Exhibits 1067, 1068, 1069, 1071, 1074, and 1075 should be
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`IPR2015-01776
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`excluded on relevance grounds.
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` Date: October 18 2016
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`Respectfully submitted,
`
` Andrea G. Reis r
`
`Registratiofi No. 36,253
`COVINGTON & BURLING LLP
`
`One CityCenter, 850 Tenth Street, NW
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`Washington, DC 20001
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`(202) 662-6000
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`Attorney for Patent Owner
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`
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`CERTIFICATE OF SERVICE
`
`Pursuant to 37 C.F.R. § 42.6, I hereby certify that on this 18th day of
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`October 2016, the foregoing Patent Owner’s Reply to Petitioner’s Response to
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`Patent Owner’s Motion to Exclude Evidence Pursuant to 37 C.F.R. § 42.64 was
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`served by electronic mail, by agreement of the parties, on the following counsel of
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`record for petitioner.
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`Jeffrey D. Blake
`Kathleen E. Ott
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`Peter A. Gergely
`Ryan James Fletcher
`Brent E. Routman
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`Merchant & Gould PC
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`KerydinIPR@merchantgould.com
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`Date: October 18,2016
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`5/,«ré’”,Z!”Lr,‘&
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`4
`\_
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`‘’
`
`ii
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`ister, Esq.
`Andrea G.
`Reg. No.: 36,253
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