`
`
`By: Jeffrey D. Blake, Esq.
` MERCHANT & GOULD P.C.
`
`191 Peachtree Street N.E., Suite 4300
` Atlanta, GA 30303
`
`jblake@merchantgould.com
` Main Telephone: (404) 954-5100
` Main Facsimile: (404) 954-509
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_____________________
`
`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 B2)
`____________________
`PETITIONER’S RESPONSE TO PATENT OWNER’S MOTION TO
`EXCLUDE EVIDENCE PURSUANT TO 37 C.F.R. § 42.64
`
`
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`
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`IPR2015-01776
`Patent 7,582,621 B2
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`Petitioner Coalition for Affordable Drugs X, LLC (“CFAD” or “Petitioner”)
`
`responds to Patent Owner’s Motion To Exclude Evidence Pursuant To 37 C.F.R. §
`
`42.64. (Paper No. 57.) Patent Owner (“PO”) does not move to exclude any
`
`evidence upon which the Board relied in properly granting institution of the
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`Petition. (Paper No. 24.) The Board should deny PO’s motion because each of the
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`challenged exhibits complies with the Federal Rules Evidence (“FRE”), relevant
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`case law, and the PTAB’s rules as codified in the Code of Federal Regulations,
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`Title 37, at Part 42.
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`I.
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`PROCEDURAL BACKGROUND
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`1.
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`On March 8, 2016, PO filed its objections to evidence served with
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`Petitioner’s petition for inter partes review pursuant to 37 C.F.R. § 42.64.
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`2.
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`The Parties met and conferred on March 11, 2016 concerning the
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`adjustment of DUE DATES 1 and 2 in the Scheduling Order dated February 23,
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`2016 and an extension of the deadline for serving supplemental evidence from the
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`original date of March 22, 2016 to the new agreed upon date of April 5, 2016.
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`3.
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`The Parties submitted a Joint Notice Of Stipulation To Adjust
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`Schedule on March 17, 2016 reflecting the parties’ agreements and the Board
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`granted the Joint Notice of Stipulation to Adjust the Schedule by e-mail on March
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`22, 2016.
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`1
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`4.
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`Petitioner timely served its supplemental evidence on April 5, 2016. 1
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`(Ex. 1085.)
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`5.
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`Petitioner filed its Reply to Patent Owner’s Response on August 24,
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`2016. (Paper No. 47.)
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`6.
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`On August 31, 2016, PO filed its objections to evidence served with
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`Petitioner’s Reply pursuant to C.F.R. § 42.64.
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`II.
`
`PETITIONER’S RESPONSES TO PO’S ARGUMENTS
`
`A.
`
`Exhibit 1024: BioborJF® Specification Sheet Is Admissible
`
`Ex. 1024 is a BioborJF® Specification Sheet. Petitioner timely served a
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`supplemental declaration (Ex. 1036) updating the web address for Ex. 1024 and a
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`supplemental declaration form its expert (Ex. 1042). (Ex. 1036 at ¶ 3; Ex. 1085.)
`
`Ex. 1036 merely updates the web address for the location of the BioborJF®
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`Specification Sheet, which changed after the original declaration was filed. Ex.
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`1042 merely updates Dr. Murthy’s reliance on the supplemental exhibits. PO
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`moves to exclude the BioborJF® Specification Sheet on grounds of authenticity
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`and hearsay. Petitioner notes PO does not move to exclude this very same
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`
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`1 PO’s motion mistakenly asserts that no supplemental evidence was served in
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`response to PO’s objections to Exs. 1024, 1025, 1031, and 1032, but Petitioner
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`timely served supplemental Exs. 1036, 1038, 1040, 1041, and 1042. (Ex. 1085.)
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`2
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`IPR2015-01776
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`exhibit in related IPR2015-01785.
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`1.
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`The BioborJF® Specification Sheet Is Properly Authenticated
`
`Petitioner has produced evidence sufficient to support a finding that the
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`BioBorJF® Specification Sheet is what Petitioner claims. Fed. R. Evid. 901(a).
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`The burden of proof for authentication is “slight.” Google Inc. v. Intellectual
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`Ventures II LLC, IPR2014-01031, Paper 41 at 7-9 (PTAB Dec. 7, 2015). Rule
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`901(a) only requires sufficient evidence of authenticity to support a prima facie
`
`case that the item is genuine. Id. In addition, “the Board, sitting as a non-jury
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`tribunal with administrative expertise, is well positioned to determine and assign
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`appropriate weight to evidence.” Mylan Pharms. Inc. v. Yeda Research &
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`Development Co. LTD., IPR2015-00644, Paper 86 at 35 (PTAB Aug. 24, 2016).
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`Petitioner timely served a supplemental declaration from counsel (Ex. 1036
`
`at ¶ 3) with the new web address for the BioborJF® Specification Sheet on April 5,
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`2016, which had changed since counsel’s declaration was originally filed (Ex.
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`1030 at ¶ 2). Ex. 1024 is properly authenticated because counsel’s declaration
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`recites the proper web address and that Ex. 1024 is a true and correct copy of the
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`BioborJF® Specification Sheet currently available at said web address, a web
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`address that specifically recites Biobor and BioBorJF® within its name. ForeWord
`
`Magazine, Inc. v. OverDrive, Inc., Case No. 10-1144, 2011 U.S. Dist. LEXIS
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`125373, at *9-11 (W.D. Mich. Oct. 31, 2011); Osborn v. Butler, 712 F. Supp. 2d
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`3
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`1134, 1146 (D. Idaho 2010); Premier Nutrition, Inc. v. Organic Food Bar, Inc.,
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`No. 06-0827, 2008 U.S. Dist. LEXIS 78353, at *16-17 (C.D. Cal. Mar. 27, 2008);
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`Google, IPR2014-01031, Paper 41 at 7-9; SIDI Tech., Inc. v. Bose Corp., IPR2013-
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`00350, Paper 36 at 16-18 (PTAB Nov. 7, 2014). PO does not identify a single
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`reason why the BioBorJF® Specification Sheet is unreliable.
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`The BioborJF® Specification Sheet is also authenticated because it includes
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`distinctive characteristics pursuant to FRE 901(b)(4) and is self-authenticating
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`pursuant to FRE 902(7). Alexander v. CareSource, 576 F.3d 551, 561 (6th Cir.
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`2009). The BioborJF® Specification Sheet includes the HAMMONDS® and the
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`BioborJF® trade logos in bold, red print across the top of the first page and the
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`address for Hammonds Fuel Additives along with the Biobor website at the bottom
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`of the first page.
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`Patent Owners reliance on EMC Corp. v. PersonalWeb Techs., LLC is
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`inapposite because the relevant part of the EMC decision addressed a party’s
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`submission of documents from the Wayback Machine as prior art. IPR2013-00084,
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`Paper No. 64 at 42-46. Petitioner is not relying on the Biobor® Specification Sheet
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`as prior art. Rather, Petitioner is offering the Biobor® Specification Sheet for the
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`purpose of providing relevant context and background concerning a product
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`specifically mentioned by Brehove (Ex. 1003 at ¶ [15]), the contents of which are
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`further corroborated by Patent Owner’s Exhibit 2006, a 1993 EPA report
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`concerning Biobor. (Ex. 2006 at 1.)
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`
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`2.
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`The BioborJF® Specification Sheet Is Not Hearsay
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` The BioborJF® Specification Sheet is not hearsay because Petitioner is not
`
`offering it to prove the truth of any specific statement therein; rather, it is offered
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`to provide relevant context and background concerning the product cited and
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`discussed by Brehove. United States v. Castro-Lara, 970 F.2d 976, 980-981 (1st
`
`Cir. 1992). The BioborJF® Specification Sheet is background information whose
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`truth is established by PO’s own evidence, e.g., Exhibit 2006.
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`Even if Exhibit 1024 were hearsay, it is still admissible under the hearsay
`
`exception set forth in FRE 803(17). The Biobor® Specification Sheet is admissible
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`as an “other compilation[] that [is] generally relied on by the public or by persons
`
`in particular occupations” pursuant to FRE 803(17). In re Boston Scientific Corp.,
`
`No. 2:13-cv-28892, 2015 U.S. Dist. LEXIS 42625, at *11, f.1 (S.D. W. Va. Apr. 1,
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`2015). The information within the BioborJF® Specification Sheet is also
`
`admissible under FRE 703 because it is the type of facts and data that Dr. Murthy
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`reasonably relied on in forming his opinions and there is no danger of prejudicial
`
`effect because this is a bench trial. (Ex. 1042 at ¶ 7.)
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`B.
`
`Exhibit 1025: BioborJF® Material Safety Data Sheet (2004) Is
`Admissible
`
`Ex. 1025 is an MSDS for BioborJF®. Petitioner timely served a
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`supplemental MSDS for BioborJF® from the certified prosecution history of
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`Brehove as Ex. 1038. (Ex. 1036 at ¶ 5; Ex. 1038; Ex. 1085.) The MSDS in Ex.
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`1038 is the same as Ex. 1025 with the exception of the publication date. PO moves
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`to exclude the BioborJF® MSDS on grounds of authenticity and as hearsay.
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`Petitioner notes PO does not move to exclude this very same exhibit in related
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`IPR2015-01785.
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`
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`1.
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`The BioborJF® MSDS Is Properly Authenticated
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`PO does not identify any reason why Ex. 1025, which is dated, is unreliable.
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`In addition, Petitioner timely served a subsection of a certified copy of the Brehove
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`prosecution history that includes the BioborJF® MSDS, which has a publication
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`date of January 1, 2000, and was submitted to the Patent Office in an Information
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`Disclosure Statement on May 25, 2002. (Ex. 1038.) The replacement BioborJF®
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`MSDS is Exhibit 1038, which is detailed in the declaration of Petitioner’s counsel
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`(Ex. 1036 at ¶ 5).
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`The BioborJF® MSDS from the certified prosecution history of Brehove is
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`self-authenticating under FRE 902(1), 902(4), and 902(5). United States ex rel.
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`Parikh v. Premera Blue Cross, No. C01-01476P, 2006 U.S. Dist. LEXIS 70933, at
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`*9-10 (W.D. Wash. Sept. 29, 2006); Omega S.A. v. Omega Eng’g, 228 F. Supp. 2d
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`112, 120 f. 26 (D. Conn. 2002).
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`2.
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`The BioborJF® MSDS Is Not Hearsay
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`The BioborJF® MSDS is not hearsay because prior art submitted as a
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`printed publication under 35 U.S.C. § 102 is offered simply as evidence of what it
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`describes, not for proving the truth of the matters addressed in the document. EMC
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`Corp. IPR2013-00084, Paper 64 at 48; Joy Techs., Inc. v. Manbeck, 751 F. Supp.
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`225, 233 n.2 (D.D.C. 1990). Even if the BioborJF® MSDS were hearsay, it
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`qualifies as an “other compilation” under FRE 803(17). In addition, the
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`information within the BioborJF® MSDS is also admissible under FRE 703
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`because it is the type of facts and data that Dr. Murthy reasonably relied on in
`
`forming his opinions. (Ex. 1042 at ¶ 7.)
`
`C.
`
`Exhibit 1031 & Ex. 1032: Kerydin® Price Information Is
`Admissible
`
`Ex. 1031 is a printout from the website www.goodrx.com. Ex.1032 is a
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`printout from the website www.q1medicare.com. Petitioner timely served
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`supplemental copies of Exs. 1031 and 1032 as Exs. 1040 and 1041. (Ex. 1085.)
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`Exs. 1040 and 1041 merely add additional pages from each website to address
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`PO’s objections. (Ex. 1036 at ¶¶ 6-7; Ex. 1040; Ex. 1041.) PO moves to exclude
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`the websites on grounds of authenticity, hearsay, and relevance.
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`1.
`
`The GoodRx And Q1Medicare Website Printouts Are Properly
`Authenticated
`
`Petitioner has produced evidence sufficient to support a finding that the
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`GoodRx printout and Q1Medicare printout are what Petitioner claims. (See Section
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`II.A.1.) Like original Exs. 1031 and 1032, supplemental Exs. 1040 and 1041 have
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`the date stamp and website address in the header and footer of the exhibit and are
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`detailed as true and accurate printouts of each website in the declaration of
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`Petitioner’s counsel (Ex. 1030 at ¶¶ 4-5; Ex. 1036 at ¶¶ 6-7). Therefore, like the
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`original Exs. 1031 and 1032, supplemental Exs. 1040 and 1041 are properly
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`authenticated pursuant to FRE 901. (See Section II.A.1.)
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` 2. The GoodRx And Q1Medicare Website Printouts Are Not
`Hearsay
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`Neither Ex. 1040 nor Ex. 1041 is hearsay because Petitioner is not offering
`
`them to prove the truth of any specific statement therein; rather, they are offered to
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`provide relevant context and background concerning the availability of Kerydin®.
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`Castro-Lara, 970 F.2d at 981.
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`Even if either website were hearsay, they both qualify as a market reports or
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`similar commercial publications that are generally relied on by the public pursuant
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`to FRE 803(17). The GoodRx website explains “every week we collect millions of
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`prices and discounts from pharmacies, drug manufacturers and other sources” so
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`that consumers can “[u]se GoodRx’s drug price search to compare prices (just like
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`you do for travel and electronics on other sites) for your prescription at pharmacies
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`near you.” (Ex. 1040 at 4.) The GoodRx website further explains that “[w]e can
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`assure you that our prices are accurate and the discounts we find are based on
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`contractual agreements. Every month, consumers save millions of dollars with
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`GoodRx.” (Id.) Furthermore, publications like the Wall Street Journal have
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`recommended the GoodRx website. (Id. at 7-28.)
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`Like the GoodRx website, the Q1Medicare website explains “[w]e provide
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`our Q1Medicare.com site for educational purposes and strive to present unbiased
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`and accurate information” and “Q1Medicare.com offers a large selection of
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`[information] to help Medicare beneficiaries, healthcare professionals, advocates,
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`advisers, caregivers, and insurance agents better understand both the Medicare Part
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`D prescription drug and Medicare Advantage programs.” (Ex. 1041 at 7, 9.) The
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`Q1Medicare website further explains that the “Q1Group makes every effort to
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`ensure that the Q1Medicare.com site is factually accurate and provides content and
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`tools that can assist with the understanding or selection of a Medicare Part D plan.”
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`(Id. at 10-11.) Therefore, even if these exhibits are hearsay they are still admissible
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`under FRE 803(17).
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`3.
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`The GoodRx Website And Q1Medicare Website Printouts Are
`Relevant And Probative
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` Both websites are relevant and probative as rebuttal to the long-felt need
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`and praise arguments advanced by PO concerning Kerydin®. PO asserts Kerydin®
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`meets a long-felt need and has received praise in the industry. (Paper No. 32 at 61-
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`64.) PO relies on Ex. 2063 (Paper No. 32 at 64) to support its argument. But Ex.
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`2063 also states that one factor to consider when choosing an onychomycosis
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`treatment is that Kerydin® costs substantially more than cyclopirox, “which may
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`discourage many patients from choosing th[is] newer agent[].” (Ex. 2063 at 10.)
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`The price of Kerydin® as disclosed by Petitioner’s exhibits directly rebuts PO’s
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`secondary considerations arguments. Therefore, the GoodRx website and the
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`Q1Medicare website are relevant to and probative of secondary consideration
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`arguments raised by PO.
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`D.
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`Exhibit 1051: PO’s Press Release Is Admissible
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`Ex. 1051 is a press release from PO’s website. PO moves to exclude Ex.
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`1051 on grounds of authenticity and hearsay.
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`
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`1.
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`PO’s Press Release Is Properly Authenticated
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`Petitioner has produced evidence sufficient to support a finding that PO’s
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`own press release is what Petitioner claims. (See Section II.A.1.) Notably, PO does
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`not deny the authenticity of its own press release or identify a single reason why its
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`own press release is unreliable.
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`Ex. 1051 is properly authenticated because a declaration from Petitioner’s
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`counsel (Ex. 1080 at ¶ 5) recites the proper web address and that Ex. 1051 is a true
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`and correct copy of the PO’s press release currently available at said web address,
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`a web address that specifically recites Anacor within its name and is dated June 10,
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`10
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`2009. (See Section II.A.1.)
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` PO’s press release is also authenticated because it includes distinctive
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`characteristics pursuant to FRE 901(b)(4) and is self-authenticating pursuant to
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`FRE 902(7). Alexander, 576 F.3d at 561. PO’s press release includes PO’s
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`trademark in the top left corner, its website address at the bottom of page 1, contact
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`information for “investor relations” at the bottom of page 2, and is available on
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`PO’s website. The collective evidence is more than sufficient to establish that PO’s
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`press release is what Petitioner purports under FRE 901(a) and 901(b)(4) in
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`addition to being self-authenticating under FRE 902(7).
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`
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`2.
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`PO’s Press Release Is Not Hearsay
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` PO’s press release is not hearsay because it is an opposing party’s statement
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`pursuant to FRE 801(d)(2)(A).
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`E.
`
`Exhibits 1067 And 1068: Material Safety Data Sheets Are
`Admissible
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`Ex. 1067 is an MSDS from Sigma-Aldrich for naphtha, a component of
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`BioborJF®. Ex. 1068 is an MSDS from for tavaborole. PO moves to exclude Exs.
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`1067 and 1068 on grounds of authenticity and relevancy. Petitioner notes that PO
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`does not move to exclude these very same exhibits in related IPR2015-01785.
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`
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`1.
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`The MSDS Sheets Are Properly Authenticated
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`Petitioner has produced evidence sufficient to support a finding that Exs.
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`1067 and 1068 are what Petitioner claims. (See Section II.A.1.) Exs. 1067 and
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`1068 are properly authenticated because a declaration from Petitioner’s counsel
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`(Ex. 1080 at ¶¶ 9-10) recites the proper web addresses and that each exhibit is a
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`true and correct copy of the MSDS currently available at said web addresses,
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`which each include the company’s name. (See Section II.A.1.) In addition, PO’s
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`expert Dr. Reider authenticated Ex. 1067 during his deposition. (Ex. 1048 at
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`336:21-337:25.)
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` Exs. 1067 and 1068 are also authentic because each includes distinctive
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`characteristics pursuant to FRE 901(b)(4) and is self-authenticating pursuant to
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`FRE 902(7). Alexander, 576 F.3d at 561. Exs. 1067 and 1068 each include
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`trademarks, contact information, website addresses, and publication and/or revision
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`dates along the top of the exhibit. (Exs. 1067, 1068)
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`
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`2.
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`The MSDS Sheets Are Relevant
`
`The fact that the MSDS sheets published after the earliest priority date for
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`the challenged patents does not render them irrelevant. Teva Neuroscience, Inc. v.
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`Watson Pharma., Inc., No. 10-5078, 2013 U.S. Dist. LEXIS 66862, at *5-7 (D.N.J.
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`May 10, 2013); Amgen Inc. v. Hoechst Marion Rousse, 314 F.3d 1313, 1336 (Fed.
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`Cir. 2003); Mylan, IPR2015-00644, Paper 86 at 34. Indeed, the inherent chemical
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`properties of naphtha and tavaborole have remained the same.
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`The remainder of PO’s argument goes to the weight of the evidence, not
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`relevancy. PO made the MSDS warnings of naphtha and tavaborole relevant by
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`arguing no one would have applied BioborJF® to their skin based on the MSDS
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`warnings. (Paper No. 32 at 38.) But, Brehove did not apply BioborJF® to anyone’s
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`skin. (Ex. 1003 at [0030].) Regardless, the MSDS sheets are directly relevant to
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`PO’s arguments concerning the warnings on the MSDS sheet for BioborJF®.
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`F.
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`Exhibits 1069 And 1071: FDA Approval Letters Are Admissible
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`Ex. 1069 is the FDA’s approval letter for Jublia®. Ex. 1071 is the FDA’s
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`approval letter for Kerydin®. PO moves to exclude Exs. 1069 and 1071 on
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`grounds of authenticity and relevancy.
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`
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`1.
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`The FDA Approval Letters Are Properly Authenticated
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`Petitioner has produced evidence sufficient to support a finding that Exs.
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`1069 and 1071 are what Petitioner claims. (See Section II.A.1.) Exs. 1069 and
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`1071 are properly authenticated because a declaration from Petitioner’s counsel
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`(Ex. 1080 at ¶¶ 11, 13) recites the proper web addresses and that each exhibit is a
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`true and correct copy of the approval letters currently available at said web
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`addresses, which each reference FDA.gov in the web address. (See Section II.A.1.)
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` Exs. 1069 and 1071 are also authentic because each letter includes
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`distinctive characteristics pursuant to FRE 901(b)(4), is a public record pursuant to
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`FRE 901(b)(7), and is self-authenticating pursuant to FRE 902(5) and FRE 902(7).
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`Exs. 1069 and 1071 each include the Department of Health and Human Services
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`logo on the letterhead, a New Drug Application number, a variety of contact
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`information for both the FDA and the new drug applicant, and the dated electronic
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`signature for the Director of the Office Of Drug Evaluation. (Ex. 1069 at 4-8; Ex.
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`1071 at 4-9.) In addition, the New Drug Application letters are official publications
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`issued by a public authority, the FDA.
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`2.
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`The FDA Approval Letters Are Relevant
`
`The fact that the FDA Approval letters published after the earliest priority
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`for the challenged patents date does not render them irrelevant. (See Section
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`II.E.2.) In addition, PO alleges objective indicia of non-obviousness based on more
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`than long-felt need and asserts unexpected results. (Paper No. 32 at 61-64.) PO’s
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`allegations rely on a number of exhibits that compare Kerydin® and Jublia®, and
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`the FDA approval letters are directly relevant to this evidence. (Exs. 2061, 2062.)
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`G. Exhibit 1074: Henriksson et al. is Admissible
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`Ex. 1074 is a publication addressing Boron Neutron Capture Therapy
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`(BCNT). PO moves to exclude Ex. 1074 on grounds of relevancy.
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`The fact that the Ex. 1074 published after the earliest priority date for the
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`challenged patents does not render it irrelevant. (See Section II.E.2.) In addition,
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`Ex. 1074 is directly relevant to PO’s assertion that boron is toxic based on BNCT
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`publications. (Paper No. 32 at 15; Ex. 1043 at ¶¶ 14-17.)
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`H. Exhibit 1075: A.S. Kushwaha et al. Is Admissible
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`Ex. 1075 is an abstract that PO identified and submitted as an exhibit during
`
`the deposition of Petitioner’s expert, Dr. Murthy. (Ex. 2032 at 74:25-77:10;
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`102:20-103:3, 490:4-493:4.) PO moves to exclude Ex. 1075 on grounds of
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`relevancy.
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`The fact that Ex. 1075 published after the earliest priority date for the
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`challenged patents does not render it irrelevant. (See Section II.E.2.) More
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`importantly, Dr. Murthy testimony and Ex. 1075 are relevant because Dr. Murthy
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`testified during his deposition that the techniques he used to successfully penetrate
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`the nail using the compound of Ex. 1075 were well known in 2005. (Ex. 2032 at
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`15
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`490:4-493:4.)
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`IPR2015-01776
`Patents 7,582,621
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`Date: October 11, 2016
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`By:
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`Respectfully submitted,
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`MERCHANT & GOULD, P.C.
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`Respectfully submitted,
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`Jeffrey D. Blake, Esq. Reg. No. 58,884
`Kathleen E. Ott, Esq. Reg. No. 64,038
`Peter A. Gergely, Esq. (Pro Hac Vice)
`Ryan J. Fletcher, Esq., Ph.D. (Pro Hac Vice)
`Brent E. Routman, Esq. (Pro Hac Vice)
`Merchant & Gould P.C.
`191 Peachtree Street N.E., Suite 4300
`Atlanta, GA 30303
`Main Telephone: (404) 954-5100
`Main Facsimile: (404) 954-5099
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`Counsel for Petitioner
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`IPR2015-01776
`Patents 7,582,621
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`CERTIFICATE OF SERVICE ON PATENT OWNER
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`Pursuant to 37 C.F.R. § 42.6(e), the undersigned certifies that on October 11,
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`2016, a complete and entire copy of PETITIONER’S RESPONSE TO PATENT
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`OWNER’S MOTION TO EXCLUDE EVIDENCE PURSUANT TO 37 C.F.R. §
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`42.64, Exhibits 1036, 1038, 1040-1042, and 1081 – 1085, and Petitioner’s Updated
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`Exhibit List were served by email, by agreement of the parties to:
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`areister@cov.com; and
`elongton@cov.com.
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`Respectfully submitted,
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`MERCHANT & GOULD P.C.
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`By:
` Counsel for Petitioner
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