`_____________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________________
`
`
`COALITION FOR AFFORDABLE DRUGS VIII LLC, Petitioner
`
`v.
`
`TRUSTEES OF THE UNIVERSITY OF PENNSYLVANIA,
`Patent Owner, based on Electronic Records of PTO
`U.S. Patent 8,618,135 to Rader
`Filing Date: March 11, 2011
`Issue Date: December 31, 2013
`TITLE: METHODS FOR TREATING DISORDERS OR DISEASES ASSOCIATED
`WITH HYPERLIPIDEMIA AND HYPERCHOLESTEROLEMIA WHILE MINIMIZING
`SIDE EFFECTS
`_____________________
`
`Inter Partes Review No.: IPR2015-01835
`
`
`
`
`
`PETITIONER’S RESPONSE TO
`
` PATENT OWNER’S OBSERVATIONS ON CROSS-EXAMINATION OF
`
`PETITIONER’S REPLY WITNESS
`
`
`
`
`
`
`
`
`
`
`
`1. Response to Observation No. 1
`
`Petitioners respond that the cited testimony is not relevant to this
`
`proceeding. In Ex. 2306, on pages 44, lines 9-15 (cited in the observation), Dr.
`
`Zusman testified, “That dose was one of the factors that was associated with side
`
`effects in the previously conducted trials.” The cited testimony is not relevant
`
`because the testimony does not address the manner or extent in which the dose was
`
`a factor with side effects in the previously conducted trials. The answer also does
`
`not address the other factors and if the extent those other factors increased the side
`
`effects of lomitapide.
`
`2.
`
`Response to Observation No. 2
`
`Petitioners respond that the cited testimony is not relevant to this proceeding. In
`
`Ex. 2306, on pages 50, line 22-page 51, line 14 (cited in the observation), Dr.
`
`Zusman testified that he saw that Chang (Ex. 1015) stated, “similar AST and ALT
`
`elevations of a magnitude sufficient to halt the development of BMS-20138
`
`[lomitapide] were also reported.” The cited testimony is not relevant because the
`
`testimony is there is no dispute as to the specific wording of that one sentence in
`
`Chang. While Dr. Zusman answers the question that is asked, the answer does not
`
`address the basis for his opinion as why a POSA would have had motivation to
`
`restart development of lomitapide.
`
`1
`
`
`
`
`
`
`
`3. Response to Observation No. 3
`
`
`
`Petitioners respond that the cited testimony is not relevant to this
`
`proceeding. Patent Owner cites to Ex. 2306, on pages 51, line 15-page 54, line 14
`
`(cited in the observation). Patent Owner claims, Dr. Zusman testified that that
`
`Exhibit 2001, which includes the Technology Donation Agreement, is dated “May
`
`19, 2006” and “is not prior art.” As an initial matter, Patent Owner inappropriately
`
`condenses three pages of testimony into one sentence. Regardless, the cited
`
`testimony is not relevant because Exhibit 2001 contains, as an Exhibit, a restated
`
`and amended version of the Original TDA from 2003.
`
`
`
`Date: November 10, 2016
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Respectfully Submitted,
`
`Christopher Casieri
`
`
`
`
`
`
`
`2
`
`
`
`
`
`CERTIFICATE OF SERVICE
`
` The undersigned hereby certifies that the foregoing PETITIONER’S
`
`RESPONSE TO PATENT OWNER’S OBSERVATIONS ON CROSS-
`
`EXAMINATION OF PETITIONER’S REPLY WITNESS list for this proceeding
`
`were served on November 10, 2016 by delivering copies via electronic mail on the
`
`following attorneys of record for the Patent Owner.
`
`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
`
`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
`
`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
`
`
`
`Date: November 10, 2016
`
`Respectfully Submitted,
`
`/Gregory J. Gonsalves/
`Dr. Gregory J. Gonsalves (Reg. No. 43,639)
`2216 Beacon Lane
`Falls Church, Virginia 22043
`(571) 419-7252
`gonsalves@gonsalveslawfirm.com
`
`3
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