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` UNITED STATES PATENT AND TRADEMARK OFFICE
` ________________________________
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
` ________________________________
`
` PAR PHARMACEUTICAL, INC.
`
` Petitioner
`
` v.
`
` NOVARTIS AG
`
` Patent Owner
`
` ________________________________
`
` Case IPR2016-01479
`
` U.S. Patent No. 9,006,224
`
` DEPOSITION OF MARK J. RATAIN, M.D.
` Monday, August 28, 2017
` Chicago, Illinois
`
`Reporter by:
`Janice M. Kocek, CSR, CLR
`Job No. 129527
`
`TSG Reporting - Worldwide 877-702-9580
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`NOVARTIS EXHIBIT 2111
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` UNITED STATES PATENT AND TRADEMARK OFFICE
` ________________________________
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
` ________________________________
`
` PAR PHARMACEUTICAL, INC.
`
` Petitioner
`
` v.
`
` NOVARTIS AG
`
` Patent Owner
`
` ________________________________
`
` Case IPR2016-01479
`
` U.S. Patent No. 9,006,224
`
` DEPOSITION OF MARK J. RATAIN, M.D.
` Monday, August 28, 2017
` Chicago, Illinois
`
`Reporter by:
`Janice M. Kocek, CSR, CLR
`Job No. 129527
`
`TSG Reporting - Worldwide 877-702-9580
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` Monday, August 28, 2017
` 9:27 a.m.
`
` The deposition of MARK J. RATAIN,
`M.D., held at the offices of LATHAM & WATKINS,
`330 North Wabash Avenue, Chicago, Illinois
`Suite 2800, pursuant to Notice, before Janice M.
`Kocek, a Certified Court Reporter, Certified
`LiveNote Reporter, and a Notary Public of the
`State of Illinois.
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`A P P E A R A N C E S:
` LATHAM & WATKINS
` Attorneys for Par Pharmaceutical, Inc.
` 330 North Wabash Avenue
` Chicago, Illinois 60611
` BY: BRENDA DANEK, ESQ.
`
` FITZPATRICK, CELLA, HARPER & SCINTO
` Attorneys for Novartis AG
` 1290 Avenue of the Americas
` New York, New York 10104
` BY: CHARLOTTE JACOBSEN, ESQ.
` JARED STRINGHAM, ESQ.
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` MARK J. RATAIN, M.D.
` (Witness sworn.)
`M A R K J. R A T A I N M. D. ,
` called as a witness, having been
` duly sworn by a Notary Public, was
` examined and testified as follows:
`EXAMINATION BY
`MS. JACOBSEN:
` Q. Good morning, Dr. Ratain. 09:27
` A. Good morning, Ms. Jacobsen. 09:27
` Q. I know that you have been deposed 09:27
`before, but just so that we're on the same 09:27
`page, I will try not to interrupt any of your 09:27
`answers, and I ask that you wait until I've 09:27
`finished my question before you start speaking 09:27
`so we have a clear record. 09:27
` Is that okay? 09:27
` A. Yes. 09:27
` Q. And if you don't understand my 09:27
`question, will you ask me to rephrase it? 09:27
` A. Yes. 09:27
` Q. And if you don't ask me to rephrase 09:27
`a question, I'm going to assume that you 09:27
`understood it. 09:27
` Is that okay? 09:27
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` MARK J. RATAIN, M.D.
` A. Yes. 09:27
` Q. And is there any reason why you 09:27
`cannot answer truthfully and to the best of 09:27
`your ability today? 09:27
` A. No. 09:27
` Q. Okay. In front of you, you have a 09:27
`binder that should have, well, the exhibits 09:27
`that you cited in your reply IPR declaration. 09:27
`And you also have Exhibit 1119, which do you 09:27
`recognize that to be your reply declaration in 09:28
`the '224 patent IPR? 09:28
` A. It appears to be. 09:28
` Q. Okay. So today we're going to be 09:28
`talking about the '224 patent, and you agree 09:28
`that that claims a method of treating advanced 09:28
`PNETs, correct? 09:28
` The patent isn't in that binder 09:28
`because you cited it in your reply declaration. 09:28
` You've been handed a copy of what 09:28
`was previously marked Exhibit 1001, which is 09:29
`the '224 patent. Do you recognize that 09:29
`document, Dr. Ratain? 09:29
` A. I do. 09:29
` Q. Do you recognize that to be the 09:29
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` MARK J. RATAIN, M.D.
`patent at issue? 09:29
` A. Okay. 09:29
` Q. And do you understand Claims 1 to 3 09:29
`to be at issue in these proceedings? 09:29
` A. I do. 09:29
` Q. And Claim 1 relates to a method of 09:29
`-- a method for treating pancreatic 09:29
`neuroendocrine tumors. 09:29
` Do you see that? 09:29
` A. I see that. 09:29
` Q. And those tumors are advanced? 09:29
` A. Yes. 09:29
` Q. And they are required to have -- to 09:29
`be treated after failure of cytotoxic 09:29
`chemotherapy? 09:29
` A. I see that. 09:29
` Q. And advanced PNETs, I think we 09:29
`agreed previously, are those that are 09:29
`unresectable or metastatic; is that right? 09:29
` A. Yes. 09:30
` Q. And a tumor that is metastatic is 09:30
`one that's spread from the primary site of 09:30
`origin to other areas of the body? 09:30
` MS. DANEK: Objection. Outside the 09:30
`
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` MARK J. RATAIN, M.D.
` scope. 09:30
` THE WITNESS: Was there a question? 09:30
`BY MS. JACOBSEN: 09:30
` Q. Yes. Is that what a metastatic 09:30
`tumor is? A metastatic PNET would be one that 09:30
`has spread from its primary site of origins to 09:30
`other sites of the body; is that right? 09:30
` A. Yes. 09:30
` MS. DANEK: Same objection. 09:30
`BY MS. JACOBSEN: 09:30
` Q. Okay. So advanced PNETs are not 09:30
`benign, right? 09:30
` A. That's correct. 09:30
` MS. DANEK: Same -- same objection. 09:30
`BY MS. JACOBSEN: 09:30
` Q. And advanced PNETs are not 09:30
`localized, correct? 09:30
` MS. DANEK: Same objection. 09:30
` THE WITNESS: An advanced PNET can 09:30
` be localized. 09:30
`BY MS. JACOBSEN: 09:30
` Q. How can an advanced PNET be 09:30
`localized? 09:30
` A. It could be locally advanced. 09:30
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` MARK J. RATAIN, M.D.
` Q. If that would be -- if it spread to 09:30
`the lymph nodes? 09:30
` MS. DANEK: Objection. Outside the 09:30
` scope. 09:30
`BY MS. JACOBSEN: 09:30
` Q. For example? 09:30
` A. That -- it could be locally 09:30
`advanced. An infiltrate doesn't have to spread 09:30
`to be locally advanced. 09:31
` Q. So what is your understanding of the 09:31
`term "localized"? 09:31
` MS. DANEK: Objection. Outside the 09:31
` scope. 09:31
`BY MS. JACOBSEN: 09:31
` Q. Sorry. Strike that. Let me reask 09:31
`it. 09:31
` As of November 2005, how would a 09:31
`POSA understand the term "localized PNET"? 09:31
` MS. DANEK: Objection. Outside the 09:31
` scope. 09:31
` THE WITNESS: Localized is not 09:31
` metastatic. 09:31
`BY MS. JACOBSEN: 09:31
` Q. So let's have a look at some of the 09:31
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` MARK J. RATAIN, M.D.
`new references that you cited in your reply 09:31
`report. I'm going to start with Exhibit 1112. 09:31
` MS. DANEK: These are all in the 09:32
` binder? 09:32
` MS. JACOBSEN: Yes. 09:32
` THE WITNESS: Would that be Tab 12? 09:32
`BY MS. JACOBSEN: 09:32
` Q. That will be Tab 12, yes. So, Dr. 09:32
`Ratain, do you have Exhibit 1112 in front of 09:32
`you? 09:32
` A. Yes. 09:32
` Q. And that is entitled "Phase II study 09:32
`of the proteasome inhibitor bortezomib (PS-341) 09:32
`in patients with metastatic neuroendocrine 09:32
`tumors." Correct? 09:32
` A. No. 09:32
` Q. What -- what did I miss? 09:32
` A. It's bortezomib. 09:32
` Q. Okay. So apart from my 09:32
`pronunciation of the drug at issue, are we on 09:32
`the right page? We're on the same reference? 09:32
` A. Yes. 09:32
` Q. Okay. And it was bortezomib? 09:33
` A. Bortezomib. 09:33
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` MARK J. RATAIN, M.D.
` Q. Okay. If I refer to this as Shah 09:33
`2004, will you understand what I'm talking 09:33
`about? 09:33
` A. Yes. 09:33
` Q. So the authors of this study 09:33
`included Hedy L. Kindler. Do you see that? 09:33
` A. Yes. 09:33
` Q. And do you know Dr. Kindler? I 09:33
`believe she was at the University of Chicago. 09:33
` A. She still is. 09:33
` Q. She still is? 09:33
` A. She is. 09:33
` Q. Is she an oncologist? 09:33
` A. She is. 09:33
` Q. And was she in 2004? 09:33
` A. Yes. 09:33
` Q. And she specialized in the treatment 09:33
`of pancreatic tumors; is that right? 09:33
` A. That's one of the things she 09:33
`specializes in. 09:33
` Q. Okay. And is she well respected in 09:33
`the oncology field? 09:33
` MS. DANEK: Objection. Outside the 09:33
` scope. 09:33
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` MARK J. RATAIN, M.D.
` THE WITNESS: I don't have an 09:33
` opinion on that one way or another. 09:33
`BY MS. JACOBSEN: 09:33
` Q. Do you respect her as an oncologist? 09:33
` MS. DANEK: Same objection. 09:34
` THE WITNESS: Again, I -- I haven't 09:34
` formed an opinion about that. 09:34
`BY MS. JACOBSEN: 09:34
` Q. I mean, she works with you, or she's 09:34
`at the University of Chicago with you, correct? 09:34
` A. Yes. She refers patients to me 09:34
`quite frequently, and I sometimes seek her 09:34
`input on -- on clinical trial opportunities 09:34
`that she may know about and I don't know about. 09:34
` Q. For example? Can you give me an 09:34
`example? 09:34
` A. An example of what? 09:34
` Q. When you may seek -- when you've 09:34
`sought her input. 09:34
` A. I maybe sought her input before I 09:34
`enroll a patient in one of my trials to also 09:34
`find out if she has any clinical trials that 09:34
`the patient may also be eligible for. 09:34
` Q. So as of November 2005, was she 09:34
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` MARK J. RATAIN, M.D.
`experienced in running clinical trials? 09:34
` A. Yes. 09:34
` MS. DANEK: Objection. Outside the 09:34
` scope. 09:34
`BY MS. JACOBSEN: 09:34
` Q. And do you have any -- any reason to 09:34
`doubt that she would put her name on a paper or 09:34
`that she -- strike that. 09:34
` Do you have any reason to believe 09:35
`that she would put her name on a paper that 09:35
`contained incorrect statements? 09:35
` MS. DANEK: Objection. Outside the 09:35
` scope. 09:35
` THE WITNESS: I haven't considered 09:35
` that one way or another. I haven't 09:35
` reviewed all of her publications and so I 09:35
` can't comment on that. 09:35
`BY MS. JACOBSEN: 09:35
` Q. So you think she could put her name 09:35
`on a paper that contained incorrect statements? 09:35
` A. I think that's possible, sure. I 09:35
`think anybody could if they don't read the 09:35
`publications carefully. 09:35
` Q. Do you think she would put her name 09:35
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`to a publication that she didn't read 09:35
`carefully? 09:35
` A. I've seen it. It's very common. 09:35
` Q. Okay. And if we look at the bottom 09:35
`left-hand corner of this paper, in the 09:35
`footnotes on the left-hand column, it says, 09:35
`"Grant support: NIH Grant CA63185." 09:35
` Do you see that? 09:35
` A. I see that. 09:35
` Q. Does that indicate that the study 09:35
`was supported by a grant from the NIH? 09:35
` MS. DANEK: Objection. Outside the 09:36
` scope. 09:36
` THE WITNESS: It says it was 09:36
` supported, at least in part, by a grant 09:36
` from the NIH. 09:36
`BY MS. JACOBSEN: 09:36
` Q. And let's have a look then -- let's 09:36
`have a look at Table 1 on page 6113 of Exhibit 09:37
`1112. 09:37
` And that indicates that all of the 09:37
`patients enrolled on this study were 09:37
`chemotherapy naive; is that right? 09:37
` MS. DANEK: Objection. Outside the 09:37
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` MARK J. RATAIN, M.D.
` scope. 09:37
` THE WITNESS: That's correct, other 09:37
` than the chemoembolization. 09:37
`BY MS. JACOBSEN: 09:37
` Q. But in terms of systemic 09:37
`chemotherapy, none of the patients had received 09:37
`systemic chemotherapy that were enrolled on 09:37
`this trial, correct? 09:37
` A. That's correct. 09:38
` Q. Okay. And if we look in the results 09:38
`under patients in the left-hand column, we see 09:38
`a majority of the patients enrolled on this 09:38
`trial had carcinoid tumors, correct? 09:38
` A. That's correct. 09:38
` Q. And the rest of them had islet cell 09:38
`tumors. Do you see that? 09:38
` A. I see that. 09:38
` Q. And islet cell tumors is another 09:38
`term for PNETs, correct? 09:38
` A. That's right. 09:38
` Q. And then if you turn to page 615, in 09:38
`the discussion, it states that stable disease 09:38
`was noted in 11 of 16 patients which was 09:38
`equivalent to 60 -- 69 percent at the median 09:38
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` MARK J. RATAIN, M.D.
`evaluation time of 12 weeks, range, 3 to 4 09:38
`weeks. 09:39
` Do you see that? 09:39
` A. I see that they say that. 09:39
` Q. And then on the next page, they 09:39
`attribute -- they say they cannot attribute 09:39
`stable disease to the antitumor effect of bor- 09:39
`-- sorry. 09:39
` Can you remind me how to pronounce 09:39
`the name of the drug? 09:39
` A. Bortezomib. 09:39
` Q. Bortezomib. So strike that. I'll 09:39
`reask the question. 09:39
` They say, "We cannot attribute 09:39
`stable disease to the antitumor effect of 09:39
`bortezomib in our single-arm study." 09:39
` Do you see that? 09:39
` A. I see that they say that. 09:39
` Q. And they -- the reason given for 09:39
`that by these authors was the slow-growing 09:39
`nature of these tumors. 09:39
` Do you see that? 09:39
` A. I see -- I see that. 09:39
` Q. And in the next sentence, they say 09:39
`
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` MARK J. RATAIN, M.D.
`the ineffectiveness of bortezomib. Do you see 09:39
`that? 09:39
` MS. DANEK: Objection. 09:40
` Mischaracterizes the document. Form. 09:40
` THE WITNESS: I mean, if you're 09:40
` asking me if it says what it says, it says 09:40
` what it says. 09:40
`BY MS. JACOBSEN: 09:40
` Q. Right. 09:40
` A. If you're asking me what it means, 09:40
`that's a whole different question, and I would 09:40
`need time to consider that. 09:40
`BY MS. JACOBSEN: 09:40
` Q. Well, at the moment, I'm just trying 09:40
`to make sure we're on the same page about what 09:40
`it says. And you agree that these authors 09:40
`classify bortezomib as ineffective, right? 09:40
` MS. DANEK: Objection. 09:40
` Mischaracterizes the document. Form. 09:40
` THE WITNESS: Well, what the authors 09:40
` say is that given that proteasome 09:40
` inhibition and tumor tissue was not 09:40
` evaluated in our study, it is conceivable 09:40
` that the ineffectiveness of bortezomib may 09:40
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` MARK J. RATAIN, M.D.
` relate to an insufficient level or duration 09:40
` of 26 proteasome inhibition in the tumors. 09:40
` That's what the sentence says. 09:40
`BY MS. JACOBSEN: 09:41
` Q. And going back, they say their study 09:41
`was not designed to evaluate progression-free 09:41
`survival. 09:41
` Do you see that? That's on the 09:41
`sentence that's bridging 6115 to 6116. 09:41
` A. Did you want me to read that 09:41
`sentence as well? 09:41
` Q. Well, if you just look at that, yes, 09:41
`have a look, and you see they say that, 09:41
`correct? 09:41
` A. Well, I'm -- if you're asking me 09:41
`what the -- what they -- what the study was 09:41
`about, I'd be happy to review it and tell you. 09:41
` If you're just asking me to read 09:41
`sentences in the study, I'm happy to do that. 09:41
`But I'm not saying anything more than agreeing 09:41
`that that's what the words say. 09:41
` Q. Okay. Understood. And can you read 09:41
`that sentence and let me know when you've done 09:41
`it? 09:41
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` MARK J. RATAIN, M.D.
` A. Okay. I will read the sentence out 09:41
`loud. 09:41
` Q. There's no need to read the sentence 09:41
`out loud. 09:41
` A. Well, then, what are you asking me 09:41
`to do? 09:41
` Q. To read the sentence to yourself and 09:41
`let me know when you're done and then I'll ask 09:41
`you the question. 09:41
` (Witness reviewed document.) 09:42
` THE WITNESS: Okay. I've read the 09:42
` sentence. 09:42
`BY MS. JACOBSEN: 09:42
` Q. So -- okay. So in the discussion 09:42
`that you just looked at, you saw that they said 09:42
`their study was not designed to evaluate 09:42
`progression-free survival. 09:42
` Do you see that? 09:42
` A. I see that. 09:42
` Q. Okay. And if we turn back to 613, 09:42
`just before -- 6113 -- sorry -- in the 09:42
`paragraph above the results, they say that -- 09:42
`they say, "Stable disease was not considered an 09:43
`objective response to therapy given the 09:43
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` MARK J. RATAIN, M.D.
`relatively slow-growing nature of these tumors 09:43
`and due to the single-arm study design." 09:43
` Do you see that? 09:43
` A. I see that. 09:43
` Q. And so the reasons that they're 09:43
`giving -- these authors are giving why stable 09:43
`disease was not considered an objective 09:43
`response to therapy was the relatively 09:43
`slow-growing nature of these tumors and due to 09:43
`the single-arm study design; is that right? 09:43
` A. Well, the authors here designed 09:43
`their study in a way based on the preclinical 09:43
`data to look only for responses and also 09:43
`included patients with indolent disease. They 09:44
`did not exclude patients that had indolent 09:44
`disease prior to enrollment. So the design was 09:44
`appropriate for the question being asked. 09:44
` Q. Right. And I'm just saying the -- 09:44
`the two reasons -- I'm not asking whether or 09:44
`not it was appropriate. 09:44
` I'm asking you to confirm that the 09:44
`reasons why they did not consider stable 09:44
`disease to be an objective response to therapy 09:44
`was the slow-growing nature of the cancers and 09:44
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` MARK J. RATAIN, M.D.
`the single-arm study design, correct? 09:44
` MS. DANEK: Objection. Form. 09:44
` THE WITNESS: Since they allowed 09:44
` enrollment of patients with prolonged 09:44
` stable disease prior to enrollment, 09:44
` therefore, observing prolonged stable 09:44
` disease after enrollment is 09:44
` uninterpretable. 09:44
`BY MS. JACOBSEN: 09:44
` Q. But they don't mention that here 09:44
`specifically; do they? They don't mention 09:44
`their enrollment criteria. They just discuss 09:44
`the slow-growing nature of these cancers. 09:44
` A. Well, a POSA would understand from 09:45
`the patients and methods, particularly the 09:45
`section on patient selection and specifically 09:45
`the eligibility criteria, what the enrollment 09:45
`criteria were, and that there was no exclusion 09:45
`of patients with indolent disease. 09:45
` Q. And if we turn to 617 -- 6117. 09:46
`Sorry -- it says -- the "In conclusion" 09:46
`sentence, do you see that? 09:46
` A. Yes. 09:46
` Q. "Single-agent bortezomib does not 09:46
`
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` MARK J. RATAIN, M.D.
`have activity in patients with metastatic 09:46
`neuroendocrine tumors." 09:46
` Do you see that? 09:46
` A. I see that. 09:46
` Q. And so this was a failed or a 09:46
`negative trial for bortezomib? 09:46
` A. I haven't considered that. 09:46
` Q. Can you -- why couldn't you consider 09:46
`that now? The conclusion reached by these 09:46
`authors were that the agent does not have 09:46
`activity in these patients, correct? 09:46
` MS. DANEK: Objection. Outside the 09:46
` scope. 09:46
` THE WITNESS: Just because the 09:46
` authors conclude something doesn't mean 09:46
` it's true. If you're asking me what a POSA 09:46
` would conclude, I haven't considered that. 09:46
`BY MS. JACOBSEN: 09:46
` Q. Okay. Would a POSA conclude that 09:46
`these authors considered it to be a failed 09:46
`trial for bortezomib? 09:46
` A. Yes. 09:46
` MS. DANEK: Objection. Outside the 09:47
` scope. 09:47
`
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` MARK J. RATAIN, M.D.
`BY MS. JACOBSEN: 09:47
` Q. Let's have another look at a 09:47
`different one. 1090. 09:47
` MS. DANEK: 9-0? 09:47
` MS. JACOBSEN: 9-0. 09:47
`BY MS. JACOBSEN: 09:47
` Q. So this is Hobday 2005. Do you 09:47
`recognize this exhibit? 09:47
` A. Yes. 09:47
` Q. Okay. And this is just an abstract, 09:47
`correct? 09:47
` A. That's right. 09:47
` Q. So it's limited in the information 09:47
`that it provides? 09:47
` MS. DANEK: Objection. Form. 09:48
` THE WITNESS: That's correct. 09:48
`BY MS. JACOBSEN: 09:48
` Q. And under the "Method" section, it 09:48
`says, "We evaluated six-month progression-free 09:48
`survival (PFS) in two separate cohorts, i.e., 09:48
`carcinoid and IC
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