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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________________
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`COALITION FOR AFFORDABLE DRUGS VIII LLC, Petitioner
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`v.
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`TRUSTEES OF THE UNIVERSITY OF PENNSYLVANIA,
`Patent Owner, based on Electronic Records of PTO
`U.S. Patent 7,932,268 to Rader
`Filing Date: June 21, 2007
`Issue Date: April 26, 2011
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`TITLE: METHODS FOR TREATING DISORDERS OR DISEASES ASSOCIATED
`WITH HYPERLIPIDEMIA AND HYPERCHOLESTEROLEMIA WHILE MINIMIZING
`SIDE EFFECTS
`_____________________
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`Inter Partes Review No.: IPR2015-01836
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`PETITIONER’S RESPONSE TO
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` PATENTOWNER’S OBSERVATIONS ON CROSS-EXAMINATION OF
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`PETITIONER’S REPLY WITNESS
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`1. Response to Observation No. 1
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`Petitioners respond that the cited testimony is not relevant to this
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`proceeding. In Ex. 2306, on pages 44, lines 9-15 (cited in the observation), Dr.
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`Zusman testified, “That dose was one of the factors that was associated with side
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`effects in the previously conducted trials.” The cited testimony is not relevant
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`because the testimony does not address the manner or extent in which the dose was
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`a factor with side effects in the previously conducted trials. The answer also does
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`not address the other factors and if the extent those other factors increased the side
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`effects of lomitapide.
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`2.
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`Response to Observation No. 2
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`Petitioners respond that the cited testimony is not relevant to this proceeding. In
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`Ex. 2306, on pages 50, line 22-page 51, line 14 (cited in the observation), Dr.
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`Zusman testified that he saw that Chang (Ex. 1015) stated, “similar AST and ALT
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`elevations of a magnitude sufficient to halt the development of BMS-20138
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`[lomitapide] were also reported.” The cited testimony is not relevant because the
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`testimony is there is no dispute as to the specific wording of that one sentence in
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`Chang. While Dr. Zusman answers the question that is asked, the answer does not
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`address the basis for his opinion as why a POSA would have had motivation to
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`restart development of lomitapide.
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`3. Response to Observation No. 3
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`Petitioners respond that the cited testimony is not relevant to this
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`proceeding. Patent Owner cites to Ex. 2306, on pages 51, line 15-page 54, line 14
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`(cited in the observation). Patent Owner claims, Dr. Zusman testified that that
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`Exhibit 2001, which includes the Technology Donation Agreement, is dated “May
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`19, 2006” and “is not prior art.” As an initial matter, Patent Owner inappropriately
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`condenses three pages of testimony into one sentence. Regardless, the cited
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`testimony is not relevant because Exhibit 2001 contains, as an Exhibit, a restated
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`and amended version of the Original TDA from 2003.
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`Date: November 10, 2016
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`Respectfully Submitted,
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`Christopher Casieri
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`2
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`CERTIFICATE OF SERVICE
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` The undersigned hereby certifies that the foregoing PETITIONER’S
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`RESPONSE TO PATENT OWNER’S OBSERVATIONS ON CROSS-
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`EXAMINATION OF PETITIONER’S REPLY WITNESS list for this proceeding
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`were served on November 10, 2016 by delivering copies via electronic mail on the
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`following attorneys of record for the Patent Owner.
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`Lead Counsel
`William G. James
`(Reg. No. 55,931)
`GOODWIN PROCTER LLP
`901 New York Avenue NW
`Washington, DC 20001
`Tel: 202-346-4046
`Fax:202-346-4444
`wjames@goodwinprocter.com
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`Backup Counsel
`Nicholas K. Mitrokostas
`GOODWIN PROCTER LLP
`Exchange Place
`53 State Street
`Boston, MA 02109-2881
`Tel: 617-570-1913
`Fax:617-523-1231
`nmitrokostas@goodwinprocter.com
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`Cynthia Lambert Hardman
`(Reg. No. 53,179)
`GOODWIN PROCTER LLP
`The New York Times Building
`620 Eighth Avenue
`New York, NY 10018-1405
`Tel: 212-459-7295
`Fax:212-355-3333
`chardman@goodwinprocter.com
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`Date: November 10, 2016
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`Respectfully Submitted,
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`/Gregory J. Gonsalves/
`Dr. Gregory J. Gonsalves (Reg. No. 43,639)
`2216 Beacon Lane
`Falls Church, Virginia 22043
`(571) 419-7252
`gonsalves@gonsalveslawfirm.com
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