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`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 VII, LLC,
`Petitioner,
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`v.
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`THE TRUSTEES OF THE UNIVERSITY OF
`PENNSYLVANIA,
`Patent Owner.
`
`Case IPR2015-01836
`Patent 7,832,268
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`PATENT OWNER’S OBSERVATIONS ON CROSS-EXAMINATION OF
`PETITIONER’S REPLY WITNESS
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`Dr. Zusman’s Reply Deposition Transcript (Ex. 2306)
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`1.
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`In Ex. 2306, on page 44, lines 9-15, in response to the question “And
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`it was generally known that for lomitapide, side effects increase with dose,
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`correct?,” Dr. Zusman testified that “That dose was one of the factors that was
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`associated with side effects in the previously conducted trials.” This testimony is
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`relevant to Petitioner’s assertion that a person of ordinary skill in the art (POSA)
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`would have been motivated to dose lomitapide according to the increasing dose
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`titration regimen in Pink Sheet, purportedly with a reasonable expectation of
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`success. See, e.g., Petitioner’s Reply (Paper 30) at pages 12-15. This testimony is
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`relevant because it demonstrates that contrary to Petitioner’s assertion, a POSA
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`would not have been motivated to use lomitapide—which was known to have
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`dose-dependent side effects—in an increasing dose titration regimen.
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`2.
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`In Ex. 2306, on page 50, line 22 – page 51, line 14, Dr. Zusman
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`agreed that Exhibit 1015 (Chang) states that “similar AST and ALT elevations of a
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`magnitude sufficient to halt the development of BMS-20138 [lomitapide] were
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`also reported.” This testimony is relevant to Petitioner’s contention that a POSA
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`purportedly would have understood that “BMS abandoned lomitapide for business
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`reasons.” See, e.g., Petitioner’s Reply (Paper 30) at pages 11 and 21. This
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`testimony is relevant because it demonstrates that a POSA would have understood
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`that BMS discontinued lomitapide due to liver toxicity, undercutting any purported
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`1
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`motivation to restart development of lomitapide.
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`3.
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`In Ex. 2306, on page 51, line 15 – page 54, line 14, Dr. Zusman
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`admits that Exhibit 2001, which includes the Technology Donation Agreement, is
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`dated “May 19, 2006” (see Ex. 2306, page 52, lines 3-6) and “is not prior art.”
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`(See Ex. 2306, page 53, line 6.) This testimony is relevant to Petitioner’s
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`contention that based on the Technology Donation Agreement, a POSA would
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`have known that “BMS abandoned lomitapide for business reasons,” and to Dr.
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`Zusman’s contention that BMS discontinued the development of lomitapide “based
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`on existing market conditions.” See, e.g., Petitioner’s Reply (Paper 30) at pages
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`11, 21. This testimony is relevant because it demonstrates that a POSA would not
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`have had access to the Technology Donation Agreement as of the claimed priority
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`date, and thus this document could not have influenced a POSA’s decision on
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`whether to restart lomitapide development following BMS’s discontinuation of the
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`drug.
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`2
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`Dated: October 28, 2016
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`Respectfully submitted,
`GOODWIN PROCTER LLP
`
`/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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`Attorney for Patent Owner
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`3
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`CERTIFICATE OF SERVICE
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`The undersigned hereby certifies that a copy of the foregoing PATENT
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`OWNER’S OBSERVATIONS ON CROSS-EXAMINATION OF
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`PETITIONER’S REPLY WITNESS was served electronically via e-mail on
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`October 28, 2016 on the following:
`
`
`Dr. Gregory Gonsalves
`2216 Beacon Lane
`Falls Church, Virginia 22043
`(571) 419-7252
`gonsalves@gonsalveslawfirm.com
`
`Christopher Casieri
`McNeely, Hare & War LLP
`12 Roszel Road, Suite C104
`Princeton, NJ 08540
`(609) 731-3668
`chris@miplaw.com
`
`Counsel for Petitioner Coalition
`for Affordable Drugs VIII, LLC
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`Dated: October 28, 2016
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`Respectfully submitted,
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`
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`/Russell W. Warnick/
`Russell W. Warnick
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