`
`IN THE UNITED STATES DISTRICT COURT
`
`FOR THE DISTRICT OF NEW JERSEY
`
`JANSSEN R&D IRELAND, et al.,
`
`)
`
`Plaintiffs,
`
`) Consolidated Civil
`
`vs.
`
`) Action No. 10-5954
`
`LUPIN LIMITED, et al.,
`
`Defendants.
`
`(WHW)
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`(CLW)
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`)
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`)
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`The videotaped deposition of GARLAND R.
`
`MARSHALL, Ph.D., called for examination,
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`taken
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`pursuant to the Federal Rules of Civil Procedure of
`
`the United States District Courts pertaining to the
`
`taking of depositions,
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`taken before Lynn A. McCauley,
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`CSR No. 84—003268, RPR, a Certified Shorthand
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`Reporter of the State of Illinois, at 6 West Hubbard
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`Street, Suite 500, Chicago, Illinois, on October 22,
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`2013, at 9:08 a.m.
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`(Page1 of11)
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`
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`BY MS. ROYZMAN:
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`Page 115
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`11:39:22
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`Q.
`
`Let me hand you as Marshall Exhibit 9 the
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`11:39:22
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`Searle '775 patent.
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`11:39:27
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`You've seen this document before,
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`11:39:32
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`Dr. Marshall?
`
`11:39:33
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`11:39:34
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`Yes,
`
`I have.
`
`A.
`
`Q.
`
`Darunavir is disclosed in Table 16K of
`
`11:39:35
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`the '775 patent; is that right?
`
`A.
`
`I'll have to look at Table 16?
`
`Q.
`
`A.
`
`16K.
`
`15K.
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`11:39:54
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`11:39:57
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`11:40:01
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`11:40:09
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`Q.
`
`Sorry.
`
`16K. Columns 161, 162.
`
`11:40:11
`
`Do you have that?
`
`11:40:19
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`A.
`
`I'm —— I'm searching for the structure.
`
`11:40:20
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`11:40:26
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`Q.
`
`It's Columns 161, 162 on the top if that
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`11:40:26
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`A.
`
`Thank you. There's a lot of different
`
`11:40:31
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`11:40:34
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`Q.
`
`There are a lot of sulfonamide HIV
`
`11:40:40
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`11:40:31
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`16K.
`
`helps.
`
`tables.
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`protease inhibitors disclosed in the '775 patent; is
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`11:40:44
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`that right?
`
`A. Definitely.
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`11:40:49
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`11:40:49
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`MS. BRODY:
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`I'm sorry. Did you withdraw the
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`11:40:53
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`(Page 2 of 11)
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`
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`prior question then?
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`THE WITNESS:
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`I don't ——
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`Page 116
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`11:40:55
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`11:40:57
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`MS. BRODY:
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`Just one second.
`
`I'm just —— you
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`11:40:58
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`asked two questions.
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`BY MS. ROYZMAN:
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`11:40:59
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`11:41:01
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`Q.
`
`Dr. Marshall,
`
`there are thousands of HIV
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`11:41:05
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`protease inhibitors disclosed in the '775 patent; is
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`11:41:09
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`that right?
`
`MS. BRODY: Objection to the form.
`
`BY THE WITNESS:
`
`11:41:13
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`11:41:13
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`11:41:14
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`A.
`
`Inhibitors disclosed.
`
`There are lots of
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`11:41:17
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`compounds which were described.
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`11:41:20
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`How many are disclosed in terms of
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`11:41:22
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`their affinity for the receptor,
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`their in vitro
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`11:41:24
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`activity and so on,
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`I don't remember, but it's a
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`11:41:28
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`common practice for patents to describe literally
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`11:41:32
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`thousands to millions of compounds for which only a
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`11:41:37
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`few examples are given, and I assume that's the case
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`11:41:41
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`for this as well.
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`11:41:44
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`I happen to know the people who
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`11:41:45
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`worked on this project,
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`this project migrated from my
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`11:41:47
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`lab to the people at Searle, so I know they made a
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`11:41:52
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`lot of sulfonamides,
`
`I can agree with that.
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`11:41:55
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`Although I was just looking at 16K,
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`11:41:58
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`(Page 3 of 11)
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`Page 117
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`and I was trying to find a structure of darunavir and
`
`11:42:00
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`I don't see it there.
`
`Q.
`
`16K, Columns 161, 162?
`
`11:42:03
`
`11:42:10
`
`A. Well,
`
`they left out an oxygen.
`
`11:42:16
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`Q.
`
`Yeah,
`
`there's —— there's some overlay
`
`11:42:19
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`issues in ——
`
`11:42:22
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`A.
`
`Okay. Well,
`
`I'm just saying if I look at
`
`11:42:23
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`this column,
`
`that is not the structure of bis—THF, so
`
`11:42:25
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`I mean it —— it may have been corrected, but in the
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`11:42:32
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`document I have, 161 on the bottom left —— I mean if
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`11:42:35
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`I go back —— if I go back to Column 219,
`
`then bis—THF
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`11:43:05
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`is certainly shown correctly.
`
`Q.
`
`A.
`
`Q.
`
`A.
`
`Column 219 is ——
`
`Yeah.
`
`—— the Claims?
`
`Or 221, yes.
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`11:43:12
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`11:43:13
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`11:43:15
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`11:43:16
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`11:43:16
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`(Whereupon, a certain
`
`document was marked
`
`Marshall No. 10 for
`
`identification.)
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`BY MS. ROYZMAN:
`
`11:43:18
`
`Q.
`
`Just to keep the record clear, let me
`
`11:43:18
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`hand you as Marshall Exhibit 10, WO 95/06030 which is
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`11:43:28
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`the PCT counterpart of this application.
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`11:43:37
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`212-267-6868
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`VERITEXT REPORTING COMPANY
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`
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`You've seen this document before,
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`11:43:47
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`Dr. Marshall?
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`11:43:49
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`A.
`
`In all candor,
`
`I probably have, but I do
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`11:43:58
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`Page 118
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`not remember it.
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`11:44:00
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`11:44:03
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`Okay.
`
`Q.
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`A.
`
`Normally what's covered in European
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`11:44:03
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`patents is a —— essentially the same as covered in
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`11:44:06
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`American patents, so if I saw it, I'm not so sure I
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`11:44:10
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`reviewed it in any great detail since I reviewed the
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`11:44:13
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`American Searle patent.
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`11:44:17
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`Q.
`
`Let's turn to Table 16K that's —— that's
`
`11:44:18
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`Page 204 on top.
`
`11:44:22
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`A.
`
`On that Table 16K the correct structure
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`11:44:33
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`of bis—THF is shown.
`
`11:44:38
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`Q.
`
`Okay. And so darunavir is disclosed in
`
`11:44:40
`
`Table 16K of Searle's patent; correct?
`
`A.
`
`Yes.
`
`11:44:42
`
`11:44:45
`
`Q.
`
`The '775 patent doesn't provide any data
`
`11:44:46
`
`for darunavir; is that right?
`
`MS. BRODY: Objection to the form.
`
`BY THE WITNESS:
`
`11:44:59
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`11:45:00
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`11:45:01
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`A.
`
`That's —— that's my understanding.
`
`11:45:01
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`BY MS. ROYZMAN:
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`11:45:03
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`Q.
`
`The '775 patent does provide data for
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`11:45:03
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`(Page 5 of 11)
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`
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`other HIV protease inhibitors; correct?
`
`MS. BRODY: Objection to the form.
`
`BY THE WITNESS:
`
`A.
`
`That's true.
`
`BY MS. ROYZMAN:
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`Page 119
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`11:45:07
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`11:45:10
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`11:45:11
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`11:45:11
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`11:45:15
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`Q.
`
`Now, I'd like to turn to Paragraph 32 of
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`11:45:16
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`your opening expert report.
`
`11:45:27
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`In Paragraph 32 on Page 10 of your
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`11:45:49
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`opening expert report you state,
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`"The '775 patent
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`11:45:52
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`also gives no indication that the claim compound
`
`11:45:56
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`darunavir would have any utility as a protease
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`11:46:00
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`inhibitor or otherwise."
`
`Do you see that?
`
`A.
`
`I do.
`
`11:46:07
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`11:46:08
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`11:46:08
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`Q.
`
`A.
`
`patent.
`
`Do you stand by that statement?
`
`11:46:09
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`I stand by that statement for the '775
`
`11:46:10
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`11:46:13
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`Q.
`
`Is it your opinion that a person of
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`11:46:13
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`ordinary skill in the art would select darunavir for
`
`11:46:16
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`further drug development based on the '775 patent?
`
`11:46:20
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`A.
`
`In 1994 the answer is no.
`
`11:46:26
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`Q.
`
`Is there a timeframe in which that answer
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`11:46:29
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`changes?
`
`A.
`
`I would think so.
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`11:46:47
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`(Page 6 of 11)
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`
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`Q.
`
`When is that?
`
`Page 120
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`11:46:48
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`A.
`
`I would suspect by the '98 patent —— or
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`11:46:49
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`the '98 paper of Ghosh and subsequent patents that
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`11:46:52
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`would have changed people's attitude about darunavir.
`
`11:46:57
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`Q. What subsequent patents?
`
`11:47:00
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`A.
`
`It could be the Tibotec patent.
`
`11:47:03
`
`I don't —— but, no,
`
`I mean,
`
`11:47:06
`
`subsequent patent.
`
`There was one, and I don't
`
`11:47:08
`
`remember the number,
`
`that I think came out of NIH
`
`11:47:12
`
`with various people on the patent; and, again, I'd
`
`11:47:15
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`have to look it up and tell you the number because I
`
`11:47:20
`
`don't recall it.
`
`11:47:22
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`Q.
`
`A.
`
`Q.
`
`You're referring to the NIH '506 patent?
`
`11:47:23
`
`I suspect that's the number, yes.
`
`11:47:26
`
`Okay.
`
`So you're —— you're not saying
`
`11:47:28
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`that based on the '775 patent alone that darunavir
`
`11:47:33
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`would be a compound of interest for drug development;
`
`11:47:40
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`correct?
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`11:47:48
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`MS. BRODY: Objection to the extent it
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`11:47:48
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`mischaracterizes the witness's testimony and the
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`11:47:50
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`opinion set forth in his expert report at Marshall
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`11:47:53
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`Exhibit 6 and in his reply report.
`
`BY THE WITNESS:
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`11:47:56
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`11:47:58
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`A.
`
`I —— I would think that anybody that was
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`11:47:58
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`(Page 7 of 11)
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`However, as someone who has done
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`12:04:11
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`Page 133
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`assays on biological systems and taught pharmacology,
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`12:04:15
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`data without error bars —— he shows error bars for
`
`12:04:20
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`14, which is 1.1 plus or minus 0.4.
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`12:04:24
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`There are no error bars given for
`
`12:04:28
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`Compound 13,
`
`therefore,
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`I don't know whether there's
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`12:04:30
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`any significant difference in those measured numbers
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`or not.
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`You know, again,
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`I had been the
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`editor for this journal,
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`I would have asked for more
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`12:04:38
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`data.
`
`BY MS. ROYZMAN:
`
`12:04:41
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`12:04:43
`
`Q.
`
`Okay. Dr. Ghosh in his 1998 article
`
`12:04:44
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`says, again, 4—methoxybenzene —— benzenesulfonamide
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`12:04:49
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`is more potent than the 4—aminobenzenesulfonamide 13
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`12:04:55
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`or the toluenesulfonamide 15.
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`12:05:01
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`12:05:05
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`12:05:06
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`Do you see that?
`
`Yes,
`
`I do.
`
`A.
`
`Q.
`
`And he describes Compound 14, which is
`
`12:05:07
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`the methoxy compound, as an extremely potent
`
`12:05:12
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`inhibitor; correct?
`
`12:05:15
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`A.
`
`Yes. And that —— and based on the same
`
`12:05:18
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`data,
`
`I would say Compound 13 is an extremely potent
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`inhibitor.
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`(Page 8 of 11)
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`BY MS. ROYZMAN:
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`Page 134
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`12:05:25
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`Q.
`
`Now, Dr. Ghosh, however, says that
`
`12:05:25
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`Compound 14, which is the methoxy compound is more
`
`12:05:32
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`potent than the 4—aminobenzenesulfonamide, Compound
`
`12:05:39
`
`13, or the toluenesulfonamide; correct?
`
`12:05:46
`
`MS. BRODY: Objection to the form. Asked and
`
`12:05:51
`
`answered. Objection to the extent it
`
`mischaracterizes the document.
`
`BY THE WITNESS:
`
`12:05:52
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`12:05:53
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`12:05:55
`
`A.
`
`I have no, you know, comment on how
`
`12:05:55
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`Dr. Ghosh interprets his data.
`
`I do have a comment
`
`12:05:59
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`on how other scientists would interpret the
`
`12:06:03
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`significance of the data and whether or not they
`
`12:06:07
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`would make those statements.
`
`BY MS. ROYZMAN:
`
`12:06:08
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`12:06:10
`
`Q.
`
`Okay. Ghosh 1998 doesn't disclose a
`
`12:06:10
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`solvate of darunavir; correct?
`
`MS. BRODY: Objection to the form.
`
`BY THE WITNESS:
`
`12:06:15
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`12:06:17
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`12:06:18
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`A.
`
`I don't know.
`
`I haven't looked for a
`
`12:06:18
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`solvate. As far as I know it doesn't, but I would
`
`12:06:21
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`have to look in detail.
`
`BY MS. ROYZMAN:
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`12:06:25
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`12:06:26
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`Q. Well, you can take your time.
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`12:06:27
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`(Page 9 of 11)
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`A.
`
`Hmm?
`
`Q.
`
`A.
`
`You can take your time.
`
`Thank you.
`
`Page 135
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`12:06:28
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`12:06:32
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`12:06:47
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`He doesn't give the sort of
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`12:06:48
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`analytical data that would allow to you decide
`
`12:06:49
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`whether or not there was a solvate or not.
`
`12:06:51
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`Q.
`
`And Ghosh 1998 doesn't provide any
`
`12:06:55
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`crystallization conditions for darunavir; correct?
`
`12:06:58
`
`A.
`
`Not in this ——
`
`MS. BRODY: Objection to the form.
`
`BY THE WITNESS:
`
`A.
`
`Not in this paper that I —— no.
`
`BY MS. ROYZMAN:
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`12:07:01
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`12:07:02
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`12:07:03
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`12:07:03
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`12:07:07
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`Q.
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`And it's correct that he doesn't provide
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`12:07:07
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`any crystallization conditions for darunavir; right?
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`12:07:10
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`A.
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`There's nothing in ——
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`12:07:14
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`MS. BRODY: Objection to the form and to the
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`12:07:15
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`extent it's outside the scope of this expert's
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`12:07:16
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`opinions.
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`BY THE WITNESS:
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`12:07:20
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`12:07:21
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`A.
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`You know, that's what's in the paper.
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`12:07:21
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`What's in the paper is what's in the paper.
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`I
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`12:07:22
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`wouldn't disagree with that —— your statement.
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`12:07:24
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`212-267-6868
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`wWw.VeriteXt.com
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`516-608-2400
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`VERITEXT REPORTING COMPANY
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`Janssen Ex. 2045
`
`Lupin Ltd. v. Janssen Sciences Ireland UC
`|PR2015-01030
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`(Page 10 of 11)
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`
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`BY MS. ROYZMAN:
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`Page 136
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`12:07:27
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`Q.
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`Okay. And Ghosh 1998 doesn't provide any
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`12:07:28
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`data against mutant HIV virus; is that right?
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`12:07:32
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`MS. BRODY: Objection to the form and to the
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`12:07:36
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`extent it's outside the scope of this witness's
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`12:07:37
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`opinions.
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`BY THE WITNESS:
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`12:07:40
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`12:07:40
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`A.
`
`You know,
`
`I don't know what you want me
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`12:07:42
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`to answer.
`
`The paper is the paper.
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`BY MS. ROYZMAN:
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`12:07:43
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`12:07:45
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`Q. Well, does the paper contain any data
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`12:07:46
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`against mutant HIV virus?
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`12:07:48
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`A.
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`Not that I found. Did you find any?
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`12:07:50
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`BY MS. ROYZMAN:
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`Q.
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`I didn't.
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`A. Well, good.
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`Q.
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`So we're in agreement?
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`12:07:53
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`12:07:53
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`12:07:55
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`A. Well,
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`there are lots of things for which
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`12:07:56
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`are not in this paper. Are we going to go over them
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`12:07:59
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`all?
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`12:08:01
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`Q.
`
`I'd like to turn your attention ——
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`12:08:04
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`MS. BRODY: You know what.
`
`I mean we've been
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`12:08:06
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`going well over an hour and a half now.
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`I —— just ——
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`12:08:07
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`it's a bit unfair to the witness.
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`12:08:10
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`212-267-6868
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`wWw.VeriteXt.com
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`516-608-2400
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`VERITEXT REPORTING COMPANY
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`Janssen Ex. 2045
`
`Lupin Ltd. v. Janssen Sciences Ireland UC
`|PR2015-01030
`
`(Page 11 of 11)