IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`COALITION FOR AFFORDABLE DRUGS X LLC,
`Petitioner,
`
`v.
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`ANACOR PHARMACEUTICALS, INC.,
`Patent Owner.
`
`Case IPR2015-01776
`Patent 7,582,621
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`PATENT OWNER’S OBJECTIONS TO PETITIONER’S EVIDENCE
`UNDER 37 C.F.R. § 42.64(b)(1)
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` DC: 5989539-3
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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 IPR2015-01776
`Patent 7,582,621
`
`PATENT OWNER’S OBJECTIONS TO PETITIONER’S EVIDENCE
`UNDER 37 C.F.R. § 42.64(b)(1)
`
`
`
`
`
`
`
`
`
`
`
`
`
` DC: 5989539-3
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`
`
`Docket No. 036914.0005-US01
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`IPR2015-01776
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`Anacor Pharmaceuticals, Inc. (“Anacor”) submits the following objections to
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`evidence served by Coalition for Affordable Drugs X LLC (“Petitioner”) with its
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`Petition for Inter Partes Review of Patent No. 7,582,621 (Paper No. 1) (“Petition”).
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`These objections are timely filed within ten (10) business days from the institution
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`date (February 23, 2016) for IPR2015-01776.
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`Patent Owner reserves the right to present further objections to these or
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`additional Exhibits submitted by Petitioner, as allowed by the applicable rules or
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`other authority.
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`Exhibit 1024 – BioborJF® Specification Sheet (2015)
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`The alleged evidence presented in Exhibit 1024 is inadmissible for at least the
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`following reasons, including under the FRE:
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`Anacor objects to Exhibit 1024 as lacking authentication, and thus
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`inadmissible under FRE 901. As one example, Anacor objects on the basis that the
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`web path that Petitioner identifies as the location where Exhibit 1024 is publically
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`available is inoperable, and renders only an error. See Exhibit 1030, ¶ 2.
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`Anacor objects to Exhibit 1024 as inadmissible hearsay under FRE 801 and
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`FRE 802, as Exhibit 1024 is not being offered as evidence of what it described, but
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`rather it is being offered to prove that BioBorJF “was formulated and introduced in
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`1965 for disinfection and prevention of microbial growth in jet fuel storage tanks and
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`marine diesel fuels.” Paper No. 1, p. 19.
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`- 1 -
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`Docket No. 036914.0005-US01
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`IPR2015-01776
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`Anacor further objects to Exhibit 1024 as being inadmissible under FRE 402
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`as lacking relevance. Anacor objects based on Petitioner’s asserted publication date
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`of the exhibit, which Petitioner asserts was published in 2015, later than the
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`applicable priority date in this case. See Paper No. 2, p. 4.
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`Exhibit 1025 – BioborJF® Material Safety Data Sheet (2004)
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`The alleged evidence presented in Exhibit 1025 is inadmissible for at least the
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`following reasons, including under the FRE:
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`Anacor objects to Exhibit 1025 as lacking authentication, and thus
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`inadmissible under FRE 901. As one example, Anacor objects on the basis that
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`Exhibit 1025 appears to be a printout of a document stored on an archived website
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`that Petitioner accessed via web.archive.org, also known as the “WayBack Machine.”
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`See Exhibit No. 1030, ¶ 3. Petitioner apparently cites this archived web version of
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`the BioborJF Material Safety Data Sheet because of the date printed on its face,
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`January 1 2004, in an attempt to demonstrate the exhibit’s relevance to the Petition.
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`However, Petitioner may not rely on the content of the exhibit without proper
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`authentication. Although the testimony of Petitioner’s counsel, Ryan J. Fletcher,
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`may establish that the exhibit is a true and correct printout of the identified website,
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`Petitioner has not provided the testimony of any witness with personal knowledge of
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`the website, and therefore the exhibit lacks authentication. See Neste Oil OYJ v. Reg
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`Synthetic Fuels, LLC, IPR2013-00578, Paper 53 at 3–4 (P.T.A.B. Mar. 12, 2015).
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`- 2 -
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`Docket No. 036914.0005-US01
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`IPR2015-01776
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`Anacor objects to Exhibit 1025 as inadmissible hearsay under FRE 801 and
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`FRE 802, as Exhibit 1025 is not being offered as evidence of what it described, but
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`rather it is being offered to prove at least the active ingredients of BioBorJF. Paper
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`No. 1, p. 19.
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`Exhibit 1031 – Kerydin® Prices
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`The alleged evidence presented in Exhibit 1031 is inadmissible for at least the
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`following reasons, including under the FRE:
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`Anacor objects to Exhibit 1031 as lacking authentication, and thus
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`inadmissible under FRE 901. Exhibit 1031 appears to be a printout of a website
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`aggregating purported prices of Kerydin® available at various pharmacies. However,
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`Petitioner may not rely on the content of the website printout without proper
`
`authentication. Although the testimony of Petitioner’s counsel, Ryan J. Fletcher,
`
`may establish that the exhibit is a true and correct printout of the identified website,
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`Petitioner has not provided the testimony of any witness with personal knowledge of
`
`the website, and therefore the exhibit lacks authentication. See Neste Oil, IPR2013-
`
`00578, Paper 53 at 3–4.
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`Moreover, Petitioner has failed to authenticate the accuracy of the prices listed
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`on the website. The website’s operator, GoodRx, states that it “is not sponsored by
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`or affiliated with any of the pharmacies identified in its price comparisons.” Exhibit
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`1031 at 3. GoodRx also states that “while we believe our data to be generally
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`- 3 -
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`Docket No. 036914.0005-US01
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`IPR2015-01776
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`accurate, we cannot guarantee that the price we display will exactly match the price
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`you receive at the pharmacy.” Id. at 2. For at least these reasons, the content of
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`Exhibit 1031 lacks authentication and should be inadmissible.
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`Anacor objects to Exhibit 1031 as inadmissible hearsay under FRE 801 and
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`FRE 802, as Exhibit 1031 is not being offered as evidence of what it described, but
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`rather it is being offered to prove the current market prices of Kerydin®. Paper No. 1,
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`p. 21.
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`Anacor further objects to Exhibit 1031 as being inadmissible under FRE 402
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`as lacking relevance. Petitioner cites Exhibit 1031 as support for its proposition 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, particularly where, as here, Kerydin® can cost up to
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`$500.00 per month or more per patient.” Paper No. 1, p. 21. Petitioner is using the
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`current market price of Kerydin® to raise an issue separate and apart from the
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`grounds raised in the Petition. See id. Anacor objects to the use of Exhibit 1031 for
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`this purpose.
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`Exhibit 1032 – Q1 Medicare 2015 Kerydin® Price
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`The alleged evidence presented in Exhibit 1032 is inadmissible for at least the
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`following reasons, including under the FRE:
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`Anacor objects to Exhibit 1032 as lacking authentication, and thus
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`inadmissible under FRE 901. Exhibit 1032 appears to be a printout of a website
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`- 4 -
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`Docket No. 036914.0005-US01
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`IPR2015-01776
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`purporting to show the average negotiated retail drug price for Kerydin® within a
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`specific Medicare insurance plan in a specific geographic region. However,
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`Petitioner may not rely on the content of the website printout without proper
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`authentication. Although the testimony of Petitioner’s counsel, Ryan J. Fletcher,
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`may establish that the exhibit is a true and correct printout of the identified website,
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`Petitioner has not provided the testimony of any witness with personal knowledge of
`
`the website, and therefore the exhibit lacks authentication. See Neste Oil, IPR2013-
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`00578, Paper 53 at 3–4.
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`Moreover, Petitioner has failed to authenticate the accuracy of the prices listed
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`on the website. The website’s operator, Q1Group LLC, states that “Medicare Part D
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`plan data changes over time and we cannot guarantee the accuracy of this
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`information.” Exhibit 1032 at 8. For at least these reasons, the content of Exhibit
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`1032 lacks authentication and should be inadmissible.
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`Anacor objects to Exhibit 1032 as inadmissible hearsay under FRE 801 and
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`FRE 802, as Exhibit 1032 is not being offered as evidence of what it described, but
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`rather it is being offered to prove the current market prices of Kerydin®. Paper No. 1,
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`p. 21.
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`Anacor objects to Exhibit 1032 as being inadmissible under FRE 402 as
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`lacking relevance. Petitioner cites Exhibit 1032 as support for its proposition that
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`“[t]he public has a significant interest in ensuring monopoly privileges are not
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`- 5 -
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`
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`Docket No. 036914.0005—US01
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`IPR2015—01776
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`granted by an invalid patent, particularly where, as here, Kerydin® can cost up to
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`$500.00 per month or more per patient.” Paper No. l, p. 21. Petitioner is using the
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`current market price of Kerydin® to raise an issue separate and apart from the
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`grounds raised in the Petition. See id. Anacor objects to the use of Exhibit 1032 for
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`this purpose.
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`Anacor further objects to Exhibit 1032 as being inadmissible under FRE 403
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`as lacking probative value. Exhibit 1032 appears to show the price of Kerydin® for a
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`single Medicare plan (Alliance Medicare PPO)
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`in a single geographic region
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`(Michigan). Exhibit 1032 at 1. Such limited and cherry—picked data is insufficient to
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`prove or demonstrate anything.
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`Date: March 8, 2016
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`Respectfully submitted,
`
`
` Andrea G. Reister
`Registration No. 36,253
`COVINGTON & BURLING LLP
`
`One CityCenter, 850 Tenth Street, NW
`Washington, DC 20001
`(202) 662-6000
`Attorney for Patent Owner
`
`
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`Docket No. 036914.0005-—USO1
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`IPR2O 15-01776
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`CERTIFICATE OF SERVICE
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`Pursuant to 37 C.F.R. § 42.6, I hereby certify that on this 8th day of March 2016, the
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`foregoing Patent Owner’s Objections to Petitioner’s Evidence Under 37 C.F.R.
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`§42.64(b)(1) was served by electronic mail, by agreement of the parties, on the
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`following counsel of 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
`
`Merchant & Gould PC
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`KerydinIPR@merchantgould.com
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`Date: March8, 2016
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`
`
`Amdrea G. Rei er, Esq.
`Registration
`o.: 36,253
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