UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`COALITION FOR AFFORDABLE
`DRUGS VII, LLC,
`Petitioner,
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`v.
`
`THE TRUSTEES OF THE UNIVERSITY OF
`PENNSYLVANIA,
`Patent Owner.
`
`Case IPR2015-01835
`Patent 8,618,135
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`PATENT OWNER’S RESPONSE TO PETITIONER’S
`OBSERVATIONS ON CROSS-EXAMINATION OF
`DR. THOMAS A. BAILLIE
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`
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`
`
`
`COALITION FOR AFFORDABLE
`DRUGS VII, LLC,
`Petitioner,
`
`v.
`
`THE TRUSTEES OF THE UNIVERSITY OF
`PENNSYLVANIA,
`Patent Owner.
`
`Case IPR2015-01835
`Patent 8,618,135
`
`
`
`
`
`PATENT OWNER’S RESPONSE TO PETITIONER’S
`OBSERVATIONS ON CROSS-EXAMINATION OF
`DR. THOMAS A. BAILLIE
`
`
`
`
`
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`
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`Patent Owner hereby files its Response to Petitioner’s Observations on
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`Cross-Examination of Dr. Thomas A. Baillie. IPR2015-01835, Paper 41.
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`
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`Response 1: Petitioner mischaracterizes Dr. Baillie’s testimony because he
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`specifically identified the “critical feature” of the invention to be the claimed
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`dosing regimen, which produced unexpected results of adaptation or tolerance to
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`toxicities of concern with lomitapide. CFAD Ex. 1060 at 8:16-10:12. Further, the
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`precise dose escalation factor needed to promote biological adaptation with
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`lomitapide is irrelevant. Although Dr. Rader used dose escalation factors that were
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`more aggressive than twofold in his phase II trial, this does not contradict Dr.
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`Baillie’s opinion that the claimed twofold escalation was both clinically efficacious
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`and non-routine. Id. at 13:14-14:5, 19:20-20-22; see also Ex. 2007 at 2. This
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`testimony is consistent with the opinions Dr. Baillie expressed in his Supplemental
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`Declaration (Ex. 2305) at ¶¶ 17, 70-75.
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`
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`Response 2: The testimony cited by Petitioner does not bear on the question of
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`what caused the amelioration of side effects seen by Dr. Rader. Dr. Baillie has
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`maintained that the improved side effect profiles observed by Dr. Rader in his
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`clinical trials (versus those conducted by BMS) cannot be attributed entirely to a
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`low-fat diet, and were instead due to Dr. Rader’s novel dosing regimen. Ex. 1060
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`
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`1
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`
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`at 51:20-54:3; Ex. 2305 at ¶¶ 71-74. Dr. Baillie testified that even if the diets in
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`BMS’s and Dr. Rader’s clinical trials were not identical, all studies employed
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`low-fat diets, and the incidence and severity of adverse events in the BMS trials
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`were shown to be dose-dependent, indicating that adverse effects are related to
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`dose, not solely diet. Ex. 1060 at 40:20-41:14, 50:15-51:19.
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`Response 3: Petitioner is incorrect that Dr. Baillie “ignore[d] evidence that
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`amelioration of side effects was due to an aggressive restriction of fat in the diet
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`of subjects taking lomitapide.” Dr. Baillie testified that although he considered
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`Exhibit 2079 in forming his opinions, he differed with Petitioner and its experts as
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`to how to interpret the statements in that document. Ex. 1060 at 38:11-40:5.
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`Furthermore, Dr. Baillie did not make “unsubstantiated assumptions” regarding
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`whether the BMS clinical trials with lomitapide employed a low-fat diet. Dr.
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`Baillie based his opinions on internal BMS documents (Ex. 2078 and 2080) that
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`describe the use of low-fat diets in clinical trials that studied the toxicity profile of
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`loimitapide. Ex. 1060 at 30:10-31:7, 32:18-34:17; Ex. 2305 at ¶¶ 73-74; Ex. 2078
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`at 2-4; Ex. 2080 at 1-2
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`Response 4: Petitioner mischaracterizes Dr. Baillie’s testimony. Dr. Baillie
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`2
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`
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`testified that although a patient undergoing the claimed forced titration method
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`might be subject to a temporary dose reduction in the case of toxicity, the patient
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`would still have to complete all of the dosing levels in order to fall within the
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`claims. Ex. 1060 at 10:18-12:23, 44:4-14. Furthermore, Dr. Baillie explained
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`that this forced titration regimen is significantly different from non-forced
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`titrations such as that proposed in Stein (Ex. 1014) and Pink Sheet 2004 (Ex.
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`1013). Id. Dr. Baillie’s testimony is consistent with the opinions expressed in his
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`Supplemental Declaration. Penn Ex. 2305 at ¶¶ 15-16, 24-25, 70.
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`
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`Response 5: Petitioner is incorrect that Dr. Rader’s citation of Wetterau in Ex.
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`2077 “contradicts” Dr. Baillie’s opinion regarding lack of reasonable expectation
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`of success. Dr. Baillie testified that in designing his clinical trial, Dr. Rader could
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`not have relied solely on Wetterau’s animal data, especially given Dr. Rader’s
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`access to proprietary BMS human data regarding lomitapide and its adverse event
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`profile. Ex. 1060 at 55:22-58:17; Ex. 2080 at 1-2. This is consistent with Dr.
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`Baillie’s opinion that although Wetterau reports pharmacodynamic data, it lacks
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`the necessary pharmacokinetic and toxicology data a POSA would need to design
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`a safe and effective human dosing regimen for lomitapide. Id. at 45:15-47:6; Ex.
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`2305 at ¶¶ 22-23, 38-39, 52.
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`3
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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
`
`Attorney for Patent Owner
`
`4
`
`Dated: November 10, 2016
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`CERTIFICATE OF SERVICE
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`The undersigned hereby certifies that a copy of the foregoing Response to
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`
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`
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`Petitioner’s Observations on Cross-Examination of Dr. Thomas A. Baillie was
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`served electronically via e-mail on November 10, 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: November 10, 2016
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`Respectfully submitted,
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`
`
`/Russell W. Warnick/
`Russell W. Warnick
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