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 REPLY IN SUPPORT OF ITS MOTION TO
`EXCLUDE EVIDENCE
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`
`COALITION FOR AFFORDABLE DRUGS VIII, LLC
`
`Petitioner
`
`v.
`
`THE TRUSTEES OF THE UNIVERSITY OF PENNSYLVANIA
`
`Patent Owner
`
`Case IPR2015-01835 (U.S. Pat. No. 8,618,135)
`
`PATENT OWNER’S REPLY IN SUPPORT OF ITS MOTION TO
`EXCLUDE EVIDENCE
`
`
`
`
`
`
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`I.
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`Exhibits 1024 And 1025 Should Be Excluded.
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`For the reasons set forth in Patent Owner’s Motion to Exclude (“Motion”
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`(Paper 38) at 1-4), the website printouts that comprise Exhibits 1024 and 1025
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`should be excluded at least on the basis of Federal Rule of Evidence (“FRE”) 901
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`as lacking authenticity.
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`Petitioner argues that the Marx Declaration (Exhibit 1034) authenticates
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`Exhibits 1024 and 1025. Pet. Opp. (Paper 44) at 1. As Petitioner explains,
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`however, the Marx Declaration attests to the respective hyperlinks where Exhibits
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`1024 and 1025 purportedly can be found. But Petitioner offers these exhibits to
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`show the purported price of Juxtapid, and nothing in the Marx Declaration speaks
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`to whether the documents accurately report this information.
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`Patent Owner also objected to Exhibit 1025 as hearsay. See Motion at 1; 3.
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`Petitioner does not directly respond to this evidentiary challenge, but instead
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`argues only that Patent Owner has not contested the prices in the exhibits. This
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`misses the point. As an evidentiary matter, Petitioner bears the burden of
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`responding to Patent Owner’s timely-made hearsay objection by showing that its
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`proffered exhibit is subject to a hearsay exception. Petitioner has not done so.
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`Finally, Petitioner has failed to respond to Patent Owner’s additional
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`arguments that Exhibit 1025 should be excluded under FRE 106 and 402/403.
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`Motion at 3-4.
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`1
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`Accordingly, Exhibits 1024 and 1025 should be excluded because they lack
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`authentication under FRE 901. Further, Exhibit 1025 should also be excluded
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`under FRE 106, 402/403, and 801/802.
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`II. Exhibits 1050-1055 (Product Labels) Should Be Excluded.
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`For the reasons set forth in the Motion, Exhibits 1050-1055, which purport
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`to be product labels for various pharmaceuticals, should be excluded under FRE
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`901 as not authenticated and under FRE 402/403 to the extent they are relied on as
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`prior art. Motion at 4-7.
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`In response to Patent Owner’s objections to the product labels, Petitioner
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`relies upon the Declaration of Christopher Casieri (“Casieri Declaration” (Ex.
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`1060)). The Casieri Declaration simply asserts that the documents comprising
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`Exhibits 1050-1055 may be downloaded from an FDA website, but fails to include
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`any facts purporting to show that the documents are what Petitioner contends they
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`are—labels for products that “were FDA approved for the treatment of HoFH at
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`the time of the invention.” Petitioner Reply (Paper 30), at 20.
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`In response to Patent Owner’s relevance objection, Petitioner argues that the
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`dates of availability of statins and ezetimibe are not contested facts (Opp. at 3), but
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`this argument again misses the mark. Petitioner has used these labels to assert that
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`“at least six drugs were FDA approved for the treatment of HoFH at the time of the
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`invention.” Motion at 4 (citing Paper 30 at 20; Paper 31 at 21)). Thus, the issue is
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`2
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`not whether statins and ezetimibe were generally commercially available prior to
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`2005, but instead whether Exhibits 1050-1055 themselves tend to show that the
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`products mentioned therein were available as of 2005. Accordingly, whether these
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`labels are what Petitioner purports them to be, as of the dates Petitioner purports
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`them to have been publicly available, is precisely the issue here, and Petitioner has
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`not proffered evidence on these points.
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`Accordingly, Exhibits 1050-1055 should be excluded because they lack
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`authentication under FRE 901. Further, because they have not been established as
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`part of the state of the art, they should be excluded under FRE 402/403 as
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`irrelevant to any issue in this proceeding.
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`III. Exhibit 1056 (Kimball Deposition Transcript) Should Be Excluded.
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`For the reasons set forth in the Motion, Exhibit 1056 should be excluded
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`under 37 C.F.R. §42.6(d) as an improper duplicate of Exhibit 2304. Motion at 7-8.
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`Exhibit 2304, filed first by Patent Owner, also includes Dr. Kimball’s signed errata
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`sheet, and is thus the more complete of the two documents. Motion at 7. To the
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`extent Petitioner cites Exhibit 1056 in its Reply, its citations can be updated to
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`reflect Exhibit 2304 in place of Exhibit 1056 if necessary.
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`IV. 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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`3
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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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`Dated: November 18, 2016
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`Attorney For Patent Owner
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`4
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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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`REPLY IN SUPPORT OF ITS MOTION TO EXCLUDE EVIDENCE to be
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`served electronically via e-mail on November 18, 2016 on the following:
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`
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`/April E. Weisbruch/
`April E. Weisbruch
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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:
`
`November 18, 2016
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