UNITED STATES PATENT AND TRADEMARK OFFICE
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`COALITION FOR AFFORDABLE DRUGS VIII, LLC
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`Petitioner
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`v.
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`THE TRUSTEES OF THE UNIVERSITY OF PENNSYLVANIA
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`Patent Owner
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`Case IPR2015-01835 (U.S. Pat. No. 8,618,135)
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`PATENT OWNER’S MOTION TO EXCLUDE EVIDENCE
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`
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`COALITION FOR AFFORDABLE DRUGS VIII, LLC
`
`Petitioner
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`v.
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`THE TRUSTEES OF THE UNIVERSITY OF PENNSYLVANIA
`
`Patent Owner
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`Case IPR2015-01835 (U.S. Pat. No. 8,618,135)
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`PATENT OWNER’S MOTION TO EXCLUDE EVIDENCE
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`I.
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`Statement of Precise Relief Requested
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`Pursuant to 37 C.F.R. § 42.64(c), Patent Owner The Trustees of the
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`University of Pennsylvania hereby moves to exclude Exhibits 1024, 1025, and
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`1050-1056, submitted by Petitioner Coalition for Affordable Drugs VIII, LLC.
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`II. Argument
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`A. Exhibits 1024 and 1025 (website printouts)
`Exhibits 1024 and 1025 appear to be website printouts. In its Exhibit List,
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`Petitioner describes Exhibit 1024 as “Prices and coupons for 30 capsules of
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`Juxtapid 5mg, 10mg, 20mg, 30mg, 40mg and 60mg (brand), GOODRX.COM,
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`http://www.goodrx.com/juxtapid (last visited July 16, 2015),” and Exhibit 1025 as
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`“Dan Mangan, ‘Fast Money’ faux pas: Firm draws FDA warning, DOJ subpoena,
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`CNBC.COM (Jan. 13, 2014), http://www.cnbc.com/id/101327742 (last visited July
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`22, 2015).” Paper 1 at vi. Petitioner cites these exhibits on page 4 of the Petition,
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`to support its allegation regarding the purported price of JUXTAPID. Paper 1 at 4.
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`On March 21, 2016, Patent Owner timely objected to Exhibits 1024 and
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`1025 as lacking authentication under Federal Rule of Evidence (“FRE”) 901.
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`Paper 9 at ¶¶ 9, 10; see 37 C.F.R. § 42.64(b)(1). Patent Owner further objected to
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`Exhibit 1025 under FRE 801/802 as hearsay (subject to no exception); under FRE
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`402/403 as not relevant to any issue in this proceeding; and under FRE 106 as
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`1
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`incomplete. Paper 9 at ¶10. Petitioner did not respond to these objections with
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`supplemental evidence or otherwise.
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`FRE 901 states: “To satisfy the requirement of authenticating or identifying
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`an item of evidence, the proponent must produce evidence sufficient to support a
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`finding that the item is what the proponent claims it is.” Petitioner fails to carry its
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`burden. Based on the description in Petitioner’s Exhibit List, it appears that
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`Petitioner would contend that Exhibits 1024 and 1025 are webpage printouts. But
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`the Petition makes no attempt to establish the province of these exhibits, and the
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`face of Exhibit 1024 lacks any indication whatsoever of a website address from
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`which the document was purportedly obtained.
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`“When offering a printout of a webpage into evidence to prove the website’s
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`contents, the proponent of the evidence must authenticate the information from the
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`website itself, not merely the printout.” See, e.g., Standard Innovation Corp. v.
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`LeLo, Inc., Case IPR2014-00148, Paper 42 at 10 (P.T.A.B. Apr. 23, 2015),
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`rehearing denied, IPR2014-00148, Paper 44 (P.T.A.B. Aug. 13, 2015); Victaulic
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`Co. v. Tieman, 499 F.3d 227, 236 (3d Cir. 2007), as amended (Nov. 20, 2007)
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`(citing United States v. Jackson, 208 F.3d 633, 638 (7th Cir. 2000)). The Board
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`has required that “[t]o authenticate printouts from a website, the party proffering
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`the evidence must produce some statement or affidavit from someone with
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`knowledge of the website . . . for example a web master or someone else with
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`2
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`personal knowledge would be sufficient.” EMC Corp. v. Personalweb Techs.,
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`LLC, Case IPR2013-00084, Paper 64 at 45-46 (P.T.A.B. May 15, 2014) (quoting
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`St. Luke’s Cataract & Laser Inst., P.A. v. Sanderson, 2006 WL 1320242, at *2
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`(M.D. Fla. May 12, 2006)), a’ffd, 612 Fed. Appx. 611 (Fed. Cir. 2015).
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`Here, Petitioner has failed to provide any witness testimony whatsoever
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`regarding the websites from where it allegedly obtained Exhibits 1024 and 1025,
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`let alone any testimony from a witness with personal knowledge that the printouts
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`themselves are authentic. Because Petitioner has failed to provide any evidence to
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`support a finding that the documents are what Petitioner claims they are, Exhibits
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`1024 and 1025 are inadmissible and should be excluded.
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` Exhibit 1025 should be excluded for three additional reasons. First, it
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`should be excluded under FRE 801/802 as hearsay (subject to no exception).
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`Exhibit 1025 contains out-of-court statements that are offered for the truth of the
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`matters therein (i.e., the purported price of JUXTAPID, see Petition, Paper 1 at 4).
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`Petitioner has not and cannot identify any hearsay exception applicable to this
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`document. Second, Exhibit 1025 should be excluded under FRE 106 as
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`incomplete. Specifically, article content appears to be missing. For example, the
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`first full paragraph of the article starts mid-sentence. Third, Exhibit 1025 should
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`be excluded under FRE 402/403 as not relevant to any issue in this proceeding.
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`Petitioner does not argue that the purported price of JUXTAPID, which is a
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`3
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`commercial embodiment of the challenged patent claims, has any relevance to
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`whether the challenged claims are unpatentable.
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`Exhibits 1050-1055 (Product Labels)
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`B.
`Exhibits 1050-1055 purport to be product labels for various pharmaceuticals.
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`In its Exhibit List, Petitioner describes the documents as follows:
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`1050
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`1051
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`1052
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`1053
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`1054
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`1055
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`FDA Label for Crestor
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`FDA Label for Vytorin
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`FDA Label for Zocor
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`FDA Label for Caduet
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`FDA Label for Lipitor
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`FDA Label for Zetia
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`Paper 30 at vii-viii. The labels contain yellow highlighting that was presumably
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`added by Petitioner. See, e.g., Ex. 1050 at 9. Petitioner cites these exhibits in
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`support of its contention that “at least six drugs were FDA approved for the
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`treatment of HoFH at the time of the invention, including Crestor, Vytorin, Zocor,
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`Caduet, Lipitor and Zetia.” Paper 30 at 20; Paper 31 at 21.1
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`1 Although Petitioner also cites Exhibits 1050-1055 in the Supplemental
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`Declaration of Randall M. Zusman, M.D. (“Supplemental Zusman Declaration”,
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`Ex. 1049), Petitioners failed to cite the relevant paragraphs of the Supplemental
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`Zusman Declaration in Petitioner’s Reply or Opposition to the Motion to Amend.
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`4
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` On September 14, 2016, Patent Owner timely objected to Exhibits 1050-
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`1055 under FRE 901 as not authenticated, and under FRE 402/403 to the extent
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`they are relied on as prior art. Paper 32 at ¶¶ 5-10. Petitioner responded with
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`supplemental evidence—specifically, a Declaration of Christopher Casieri (who is
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`backup counsel in this proceeding)—purporting to demonstrate that the labels are
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`“publically available” from the Food and Drug Administration’s website. Ex.
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`1060. Petitioner’s original proofs and supplemental evidence are insufficient to
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`authenticate the labels, let alone establish their dates of public availability.
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`As to authentication, Petitioner provides no evidence sufficient to support a
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`finding that these exhibits are in fact FDA labels.
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`As to relevance, Petitioner relies on Exhibits 1050-55 solely to prove the
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`state of the art as of March 7, 2005 (the priority date of the ’135 Patent for
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`purposes of this proceeding), but fails to establish that the labels were publicly
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`available as of that date. Paper 30 at 20; Paper 31 at 21. In its Reply, Petitioner
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`did not point Patent Owner to any characteristics of Exhibits 1050-1055 that
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`establish the labels’ purported dates of public availability. Some of the Exhibits
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`appear to bear a date, but it is unclear what the significance of that date may be
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`(i.e., a draft date, a publication date, etc.). See Exhibit 1050 at 1 of 20 (“8-12-03”
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`at top of page); see also Exhibit 1053; Exhibit 1054. Others bear no date. See
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`Exhibit 1051 at 22 of 42 (“[i]ssued XXXXXXX”); Exhibit 1055 at 15 of 17
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`5
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`(“[i]ssued MMM YYYY”). One exhibit bears a date with a strikeout. See Exhibit
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`1052 at 16 (“[i]ssued June 2001”). Thus, the documents themselves fail to
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`establish that they were accessible to the public prior to the relevant priority date.
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`And even to the extent the labels bear a date, these dates are inadequate on their
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`face to demonstrate availability to the public. See, e.g., Kinetic Technologies, Inc.
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`v. Skyworks Solutions, Inc., IPR2014-00690, Paper 43 at 18-20 (P.T.A.B. Oct. 19,
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`2015); see also Ex Parte Rembrandt Gaming Techs. LP, 2014 WL 6847163, at *3,
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`Control No. 90/012,379 (P.T.A.B. Dec. 3, 2014) (holding a copyright date does not
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`show the requisite public availability, but merely establishes the date the document
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`was created or printed).
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`Petitioner’s supplemental evidence, the Declaration of Christopher Casieri,
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`fails to remedy the shortcomings of the labels themselves. As to authentication,
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`the Casieri Declaration asserts that each exhibit is “a true and correct copy” of the
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`product label. Ex. 1060. But the Declaration provides only that bald statement,
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`without any facts whatsoever from which Patent Owner or the Board can evaluate
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`the assertion.2 As to the date of the documents, Mr. Casieri provided a link to the
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`2 Petitioner also renumbered Exhibits 1050-1055 as new Exhibits 1063-1068, in
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`order to remove yellow highlighting on the exhibits that did not appear on the
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`original documents.
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`6
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`FDA’s website and stated that each label is “publically available” on the FDA’s
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`website. Id. That assertion misses the mark, because it fails to establish the date of
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`the label vis-à-vis the relevant priority date, which is the key information needed to
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`establish these documents as part of the state of the art.
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`Accordingly, Exhibits 1050-1055 should be excluded because they lack
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`authentication and because they have not been established as part of the state of the
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`art (Petitioner’s sole attempted use of these documents), they are irrelevant to any
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`issue in this proceeding.
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`C. Exhibit 1056 (Kimball Deposition Transcript)
`Exhibit 1056 is the Deposition Transcript of S. David Kimball, Ph.D., dated
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`July 11, 2016. Petitioner cites Exhibit 1056 in its Reply (Paper 30) at pages 3-5,
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`10-11, and 14.3
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`Patent Owner timely objected to Exhibit 1056 as an improper duplicate of
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`Exhibit 2304, the Transcript of the Deposition of S. David Kimball, Ph.D. dated
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`July 11, 2016, including Dr. Kimball’s signed errata sheet. Paper 32 at ¶ 11. This
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`3 Although Petitioner also cites Exhibit 1056 in the Supplemental Zusman
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`Declaration, Petitioners failed to cite the relevant paragraphs of the Supplemental
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`Zusman Declaration in Petitioner’s Reply or Opposition to the Motion to Amend.
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`7
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`duplicate exhibit violates the rule that “[a] document already in the record of the
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`proceeding must not be filed again,” 37 C.F.R. §42.6(d), and should be excluded.
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`III. Conclusion
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`For the foregoing reasons, Patent Owner respectfully requests that the Board
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`exclude Petitioner’s Exhibits 1024, 1025, and 1050-1056.
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`Dated: October 28, 2016
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`Respectfully submitted,
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`/William G. James/
`William G. James
`Registration No. 55,931
`Goodwin Procter LLP
`901 New York Avenue NW
`Washington, DC 20001
`P: 202.346.4000
`F: 202.346.4444
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`Attorney For Patent Owner
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`8
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`CERTIFICATE OF SERVICE
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`The undersigned hereby certifies that I caused the PATENT OWNER’S
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`MOTION TO EXCLUDE EVIDENCE to be served electronically via e-mail on
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`October 28, 2016 on the following:
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`
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`/Russell W. Warnick/
`Russell W. Warnick
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`
`Dr. Gregory Gonsalves
`2216 Beacon Lane
`Falls Church, Virginia 22043
`(571) 419-7252
`gonsalves@gonsalveslawfirm.com
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`Christopher Casieri
`McNeely, Hare & War LLP
`12 Roszel Road, Suite C104
`Princeton, NJ 08540
`(609) 731-3668
`chris@miplaw.com
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`
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`Counsel for Petitioner Coalition
`for Affordable Drugs VIII, LLC
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`Dated:
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`October 28, 2016
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