`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`IPR 2017-00854
`------------------------------)
`APOTEX INC., APOTEX CORP.,
`ARGENTUM PHARMACEUTICALS LLC,
`ACTAVIS ELIZABETH LLC, TEVA
`PHARMACEUTICALS USA, INC., SUN
`PHARMACEUTICAL INDUSTRIES LTD.,
`SUN PHARMACEUTICAL INDUSTRIES,
`INC., and SUN PHARMA GLOBAL FZE,
` Petitioners,
` PATENT NO.
` vs. 9,187,405
`NOVARTIS A.G.,
` Patent Owner.
`------------------------------)
`
` VIDEOTAPED DEPOSITION OF
` LAWRENCE STEINMAN, M.D.
` New York, New York
` April 5, 2018
`
`Reported by:
`Linda Salzman
`JOB NO. 140361
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`APOTEX ET AL. - EXHIBIT 1061
`Apotex Inc. et al. v. Novartis AG
`IPR2017-00854
`
`
`
`Page 2
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` April 5, 2018
` 9:23 a.m.
`
` Videotaped Deposition of
` LAWRENCE STEINMAN, M.D., the witness
` herein, held at the offices of
` Gibson, Dunn & Crutcher, 200 Park
` Avenue, New York, New York, pursuant
` to Notice, before Linda Salzman, a
` Notary Public of the State of New
` York.
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`Page 3
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`A P P E A R A N C E S:
`
` WILSON SONSINI GOODRICH & ROSATI
` Attorneys for Petitioner Apotex
` 701 Fifth Avenue, Suite 5100
` Seattle, Washington 98104
` BY: JAD MILLS, ESQ.
` STEVEN PARMELLEE, ESQ.
` (via telephone)
`
` GIBSON, DUNN & CRUTCHER
` Attorneys for Patent Owner
` 200 Park Avenue
` New York, New York 10166
` BY: ROBERT W. TRENCHARD, ESQ.
` JANE M. LOVE, Ph.D., ESQ.
`
` Also Present:
` LARRY MOSKOWITZ, Videographer
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` THE VIDEOGRAPHER: Good morning. 09:22
` We are now on the record. 09:22
` This is the start of DVD No. 1 09:22
` of the video-recorded deposition of 09:22
` Lawrence Steinman, M.D., in the matter 09:22
` of Apotex Inc., et al., versus 09:22
` Novartis A.G., in the United States 09:22
` Patent and Trademark Office, before 09:23
` the Patent Trial and Appeal Board. 09:23
` This deposition is being held at 09:23
` Gibson Dunn, 200 Park Avenue, New 09:23
` York, New York, on April 5, 2018 at 09:23
` approximately 9:23 a.m. 09:23
` My name is Larry Moskowitz, and 09:23
` I'm the legal video specialist with 09:23
` TSG Reporting, headquartered at 747 09:23
` Third Avenue, New York, New York. The 09:23
` court reporter is Linda Salzman, also 09:23
` in association with TSG Reporting. 09:23
` Will counsel please introduce 09:23
` themselves for the record. 09:23
` MR. MILLS: My name is Jad 09:23
` Mills, with the law firm Wilson 09:23
` Sonsini Goodrich & Rosati. On the 09:23
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` phone will be joining me Steven 09:23
` Parmellee, also with Wilson Sonsini 09:23
` Goodrich & Rosati, representing 09:23
` Petitioners Apotex Inc. and Apotex 09:23
` Corp. 09:23
` MR. TRENCHARD: Robert 09:23
` Trenchard, from Gibson, Dunn & 09:23
` Crutcher. With me is my partner Jane 09:24
` Love, and we are here for the Patent 09:24
` Owner, Novartis. 09:24
` THE VIDEOGRAPHER: Will the 09:24
` reporter please administer the oath. 09:24
`L A W R E N C E S T E I N M A N, 09:24
` called as a witness, having been duly 09:24
` sworn by a Notary Public, was examined 09:24
` and testified as follows: 09:24
` MR. MILLS: I am being asked to 09:24
` open a conference line. Do you want 09:24
` to stay on the record while we do 09:24
` that? 09:24
` MR. TRENCHARD: Yes. Is there a 09:24
` particular number you want to use? 09:24
` MR. MILLS: If you have one 09:24
` handy, we can use yours. 09:24
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` L. Steinman, M.D.
`EXAMINATION BY 09:24
`MR. MILLS: 09:25
` Q. Dr. Steinman, I apologize for 09:25
`the delay. I was stuck at the building 09:25
`security for quite some time this morning. 09:25
`They didn't have me in the system and then 09:25
`they had a difficult time with their 09:25
`printer. They couldn't print my ID pad, 09:25
`so I do apologize for the late start. 09:25
` Dr. Steinman, have you been 09:25
`deposed before? 09:25
` A. Yes, I have. 09:25
` Q. How many times? 09:25
` A. 20, 30 times. 09:25
` Q. Of those 20 or 30 times, how 09:25
`many of those have been patent matters? 09:25
` A. Maybe five. 09:25
` Q. Of those five patent matters in 09:25
`which you have previously been deposed, 09:26
`have any of those been in an IPR? 09:26
` A. No. 09:26
` Q. Were all of those five patent 09:26
`matters in which you were deposed District 09:26
`Court litigations? 09:26
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` L. Steinman, M.D.
` A. I assume they were. Perhaps one 09:26
`of them was an IPR. 09:26
` Q. When I say "IPR," do you know 09:26
`what I'm talking about as opposed to 09:26
`District Court litigation? 09:26
` MR. TRENCHARD: Objection to 09:26
` form. 09:26
` You can answer. 09:26
` A. In general, but I'm not a lawyer 09:26
`so -- but I recognize the difference. 09:26
` Q. And in general, what's your 09:26
`understanding of the difference? 09:26
` MR. TRENCHARD: Objection to 09:26
` form. 09:26
` You can answer. 09:26
` A. Well, I'm not a lawyer. One is 09:26
`run by the Patent Office under certain 09:26
`rules. Another is run by the District 09:26
`Court system under different rules. But I 09:26
`wouldn't want to take a test on it. 09:26
` Q. You believe that one of the five 09:26
`patent cases in which you have been 09:26
`deposed in the past was an IPR, correct? 09:27
` A. I believe so. 09:27
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` Q. What case was that? 09:27
` A. I don't remember the caption on 09:27
`it. 09:27
` Q. What was the subject matter? 09:27
` A. Again, when I said that one of 09:27
`cases may have been an IPR, I'm just 09:27
`guessing now. So it doesn't seem 09:27
`reasonable to guess on a case that I'm not 09:27
`sure whether it was an IPR or not. 09:27
` Q. There's a particular case you 09:27
`have in mind that you think you were 09:27
`deposed in that you think it was an IPR, 09:27
`correct? 09:27
` A. Well, I'd rather not guess too 09:27
`far away from what I'm comfortable about 09:27
`knowing definitively. 09:27
` Q. But there's a case that you have 09:27
`in mind that you've been thinking about as 09:27
`we've been talking, correct? 09:27
` MR. TRENCHARD: Objection to 09:27
` form. 09:27
` You can answer. 09:27
` A. Perhaps. But again, it's my 09:27
`nonlawyer recollection of a case in the 09:28
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` L. Steinman, M.D.
`past. I'm not trying to be evasive. It's 09:28
`just that as a nonlegal person, it's hard 09:28
`for me to give very much more detail than 09:28
`that. 09:28
` Q. You do have in your mind a 09:28
`thought that you have been deposed in five 09:28
`patent cases in the past, correct? 09:28
` A. I said, as I recall, perhaps 09:28
`five. I think that's an accurate number. 09:28
` Q. So if you could, just go through 09:28
`those five and tell me in general what was 09:28
`the subject matter of each of those cases. 09:28
` A. One case was about statins. 09:28
` One case was about the subject 09:28
`at hand, as I recall. 09:28
` Another case, from about ten 09:28
`years ago, don't even recollect the exact 09:29
`subject that was involved in that one. 09:29
`Oh, yes, I do now. It was about a 09:29
`costimulatory molecule. 09:29
` Q. That's three I think that you've 09:29
`mentioned so far; is that correct? 09:29
` A. Right. And some of them had 09:29
`repeat performances, as I recall. 09:29
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` L. Steinman, M.D.
` Q. So is it correct that of the 09:29
`five cases in which you recall being 09:29
`deposed in patent matters, they're each 09:29
`represented by the three categories you 09:29
`just listed? 09:29
` MR. TRENCHARD: Objection to 09:29
` form. 09:29
` You can answer. 09:29
` A. Right. I'm just trying to 09:29
`reconstruct. That's about the best I can 09:29
`do at the moment. 09:29
` Q. The second category you 09:29
`mentioned, was what at issue, is the same 09:29
`thing that is at hand in the current 09:30
`proceeding; is that correct? 09:30
` A. That's correct. 09:30
` Q. When you say the matter at hand, 09:30
`what do you mean by that? 09:30
` A. About Fingolimod. 09:30
` Q. And how many prior cases have 09:30
`you been deposed in in which the matter at 09:30
`hand was Fingolimod? 09:30
` A. One other. 09:30
` Q. In the prior Fingolimod case, 09:30
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`what type of patent was at issue? 09:30
` MR. TRENCHARD: Objection to 09:30
` form. 09:30
` You can answer. 09:30
` A. Again, I don't remember the 09:30
`exact details at this time. 09:30
` Q. Generally, what do you recollect 09:30
`about the prior case in which you were 09:30
`deposed regarding Fingolimod? 09:30
` MR. TRENCHARD: Just make sure 09:30
` you keep your testimony to -- don't 09:30
` talk about conversations with counsel. 09:30
` So just any other recollections you 09:30
` have. 09:30
` A. It was about a Fingolimod 09:30
`patent, and I was asked to testify from my 09:30
`set of skills. 09:30
` Q. Did you testify at trial in that 09:31
`case? 09:31
` A. No. 09:31
` Q. Was that case a case before the 09:31
`Patent Office? 09:31
` A. From my nonlegal point of view, 09:31
`cases about patents involve the Patent 09:31
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` L. Steinman, M.D.
`Office, so I'm really not well enough 09:31
`qualified to give all the nuances of when 09:31
`something is in a court where the 09:31
`jurisdiction of the Patent Office ends and 09:31
`the court begins. I'm really not schooled 09:31
`in that. 09:31
` Q. Other than it's your testimony 09:31
`related to Fingolimod, can you tell me 09:31
`anything else about the subject matter of 09:31
`your testimony in your prior Fingolimod 09:31
`case? 09:31
` A. It was at a deposition, so as I 09:31
`said, the other side asked the questions, 09:31
`and I gave the answers. 09:31
` Q. In your prior Fingolimod case, 09:31
`did you submit an expert report? 09:31
` A. Yes, I did. I would call it a 09:32
`declaration, or that's what I believe it 09:32
`is called. 09:32
` Q. Do you know the difference 09:32
`between an expert report and a 09:32
`declaration? 09:32
` A. I have a nonlegal concept, but I 09:32
`don't know where the boundaries are. 09:32
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` Q. What is your nonlegal 09:32
`understanding of the difference between an 09:32
`expert report and a declaration? 09:32
` A. Simply that in other types of 09:32
`cases, I've filed reports and they're not 09:32
`called declarations. 09:32
` Q. Other than in some cases you 09:32
`filed something called a report and in 09:32
`others you filed something called a 09:32
`declaration, you don't have any other 09:32
`understanding of the difference between an 09:32
`expert report and declaration? 09:32
` A. I find the question is 09:32
`interesting and I will probably ask in the 09:32
`future, but it never specifically occurred 09:33
`to me to ask people who know those 09:33
`questions I don't know the answers. 09:33
` Q. Do you have an understanding as 09:33
`to whether in this case you submitted an 09:33
`expert report or a declaration? 09:33
` A. I believe it was a declaration. 09:33
` Q. And you submitted more than one 09:33
`declaration in this case, correct? 09:33
` A. Three. 09:33
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` L. Steinman, M.D.
` Q. You signed each of your three 09:33
`declarations in this case under penalty of 09:33
`perjury, correct? 09:33
` A. Absolutely. 09:33
` Q. In your prior Fingolimod case, 09:33
`when you submitted your expert report or 09:33
`declaration, did you sign it under penalty 09:33
`of perjury? 09:33
` A. I believe so. 09:33
` Q. Have you ever testified at a 09:33
`trial? 09:33
` A. Not in a patent case. 09:33
` Q. In what type of cases have you 09:34
`testified at trial? 09:34
` MR. TRENCHARD: Objection to 09:34
` form. 09:34
` You can answer. 09:34
` A. Product liability. And I 09:34
`testified in cases under the Vaccine 09:34
`Compensation Act of U.S. Congress in the 09:34
`Court of Special Claims. 09:34
` Q. How many times have you 09:34
`testified at a trial in a product 09:34
`liability case? 09:34
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` L. Steinman, M.D.
` A. Maybe half a dozen. 09:34
` Q. Have any of those related to 09:34
`Fingolimod? 09:34
` A. No. 09:34
` Q. How many times have you 09:34
`testified before the Vaccine Compensation 09:34
`Board? 09:34
` MR. TRENCHARD: Objection to 09:34
` form. 09:34
` You can answer. 09:34
` A. Perhaps 20 times. 09:34
` Q. None of those trials were 09:34
`related to Fingolimod, correct? 09:34
` A. That's correct. 09:34
` Q. When you previously submitted 09:34
`testimony in a prior Fingolimod case, you 09:35
`submitted that testimony on behalf of 09:35
`Novartis, correct? 09:35
` A. That's correct. 09:35
` Q. Other than the present case and 09:35
`your prior Fingolimod case, have you had 09:35
`any other professional interactions with 09:35
`Novartis? 09:35
` MR. TRENCHARD: Objection. 09:35
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` You can answer. 09:35
` A. Yes. In the past I've given 09:35
`lectures at Novartis and received market 09:35
`compensation. I've served on advisory 09:35
`panels and received market compensation. 09:35
` Q. Other than lecturing at Novartis 09:35
`for compensation and serving on advisory 09:35
`panels for compensation, and other than 09:36
`your expert work on the two Fingolimod 09:36
`cases, have you had any other compensated 09:36
`work for Novartis? 09:36
` A. I don't think so. 09:36
` Q. And other than those categories, 09:36
`have you had any other uncompensated work 09:36
`for Novartis? 09:36
` A. No. 09:36
` Q. When was the first time that you 09:36
`were paid to speak at Novartis? 09:36
` A. It would have been about ten 09:36
`years ago. 09:36
` Q. And since that time, how many 09:36
`times have you spoken at Novartis? 09:36
` A. I haven't spoken at Novartis 09:36
`since about ten years ago. 09:36
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` Q. It's correct that you've only 09:36
`lectured at Novartis once? 09:36
` A. I lectured at their precursor, 09:36
`each of their precursor companies about it 09:36
`a generation ago, about 20 years ago. One 09:36
`was Sandoz and one was Ciba-Geigy, 09:36
`C-I-B-A, dash, G-E-I-G-Y. 09:37
` Q. How many times did you lecture 09:37
`at each of those companies? 09:37
` A. Perhaps -- again, this is we're 09:37
`talking about 20 years ago, once or twice 09:37
`at each company over the years. 09:37
` Q. And you were paid for each of 09:37
`those engagements as well, correct? 09:37
` A. I would say probably so. 09:37
` Q. When you lectured at Novartis, 09:37
`did you interact with any of the same 09:37
`people that you had previously interacted 09:37
`with at the predecessor companies? 09:37
` MR. TRENCHARD: Objection to 09:37
` form. 09:37
` You can answer. 09:37
` A. No. 09:37
` Q. When you lectured at Novartis, 09:37
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` L. Steinman, M.D.
`what was your market compensation that 09:37
`Novartis paid you for that lecture? 09:37
` A. I don't remember. Generally, 09:37
`pharma pays about the same, no matter who 09:38
`is -- I think it's set up by some standard 09:38
`but I don't remember. 09:38
` Q. How many times have you been 09:38
`paid to serve on advisory panels for 09:38
`Novartis? 09:38
` MR. TRENCHARD: Objection to 09:38
` form. 09:38
` A. At least once. 09:38
` Q. When was that? 09:38
` A. About eight years ago. 09:38
` Q. What was the subject matter of 09:38
`that advisory panel? 09:38
` A. A molecule called anti-IL-17 09:38
`that had a name Secukinumab, 09:38
`S-E-C-U-K-I-N-U-M-A-B. 09:38
` Q. Is part of your work on 09:39
`Novartis's advisory panel for Secukinumab, 09:39
`did you evaluate EAE studies? 09:39
` A. Yes. 09:39
` Q. What is the disease target for 09:39
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` L. Steinman, M.D.
`Secukinumab? 09:39
` MR. TRENCHARD: Objection to 09:39
` form. 09:39
` You can answer. 09:39
` A. Well, at the time it was 09:39
`multiple sclerosis, but they stopped 09:39
`development. 09:39
` Q. Your lecture at Novartis ten 09:39
`years ago, generally what was the subject 09:39
`matter of that lecture? 09:39
` A. Biomarkers. 09:39
` Q. Biomarkers for generally or for 09:39
`a particular indication? 09:39
` A. Generally for interferons in 09:39
`multiple sclerosis. 09:40
` Q. What are interferons for 09:40
`multiple sclerosis? 09:40
` A. They're one of the classes of 09:40
`approved drugs. 09:40
` Q. Approved drugs for multiple 09:40
`sclerosis? 09:40
` A. For relapsing-remitting multiple 09:40
`sclerosis. 09:40
` Q. When were interferons first 09:40
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` L. Steinman, M.D.
`approved for RRMS? 09:40
` A. In the 1990s. 09:40
` Q. Were interferons approved by the 09:40
`FDA in the 1990s to reduce relapses in 09:40
`RRMS? 09:40
` A. Yes. 09:40
` Q. Were interferons approved in the 09:40
`1990s to prevent relapses in RRMS? 09:40
` A. Yes. 09:40
` Q. Were interferons approved in the 09:40
`1990s to alleviate relapses in RRMS? 09:40
` A. My general answer is yes, but I 09:40
`don't know -- at the moment I'm speaking 09:41
`here now exactly what the label says. 09:41
` So you just used the word 09:41
`"alleviate." Before that you used the 09:41
`word "prevent." And I just want to say 09:41
`that I don't know what the actual label 09:41
`reads, and if I were out on the street, I 09:41
`might use those differently. 09:41
` So my precise answer is I don't 09:41
`want to be in the position of 09:41
`distinguishing without having a lot more 09:41
`information in front of me. 09:41
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` L. Steinman, M.D.
` And I only say that because I 09:41
`just want to be as accurate as I can be 09:41
`and words change -- prevent, alleviate -- 09:41
`pretty similar, but it depends, of course, 09:42
`on the context. And I don't know exactly 09:42
`the choice of wording in the label. 09:42
` Q. When you use the words "prevent" 09:42
`versus "alleviate relapses," do you have 09:42
`an understanding of those terms as a 09:42
`medical professional who treats multiple 09:42
`sclerosis patients? 09:42
` MR. TRENCHARD: Objection to 09:42
` form. 09:42
` You can answer. 09:42
` A. I am a neurologist who treats 09:42
`multiple sclerosis patients. And again, 09:42
`it's the context of the environment. If 09:42
`I'm talking to a patient with multiple 09:42
`sclerosis in a room, and the patient says: 09:42
`So this drug, what will it do for me. I 09:43
`understand I have relapsing disease. 09:43
` They might ask me will this 09:43
`prevent a future relapse. They might ask 09:43
`in terms of the word alleviate, will this 09:43
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` L. Steinman, M.D.
`make my relapse milder. So those are all 09:43
`valid questions that they might ask. 09:43
` Q. So in the context of treating 09:43
`RRMS, when you use the term "alleviate" or 09:43
`"relapse," that refers to making a relapse 09:43
`milder? 09:43
` MR. TRENCHARD: Objection to 09:43
` form. 09:43
` A. Again, context is very 09:43
`important, so if we're talking to the 09:43
`hypothetical patient in a room, I might 09:44
`loosen up and not try to make dramatic 09:44
`distinctions. But I want to be very 09:44
`careful about my choice of words in the 09:44
`present context. 09:44
` Q. Is it correct that there are -- 09:44
`that there is more than one meaning 09:44
`encompassed by the term "alleviate 09:44
`relapses"? 09:44
` MR. TRENCHARD: Objection to 09:44
` form. 09:44
` A. It's a general question, and 09:44
`again, I'm trying to be precise, helpful, 09:44
`accurate, so it really does depend on the 09:44
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` L. Steinman, M.D.
`context. I can assure you that I wouldn't 09:44
`make a patient uncomfortable by parsing as 09:44
`accurately as I could my words. I would 09:45
`do it in the context of how are they 09:45
`receiving my information and above all, am 09:45
`I accurate in making them feel better. 09:45
` But that's very different than 09:45
`the question in this context. 09:45
` Q. So let's start, we can take 09:45
`those each at a time. Let's start with 09:45
`the question in this context. 09:45
` So what does "alleviating 09:45
`relapses" mean in the context of this 09:45
`proceeding? 09:45
` MR. TRENCHARD: Objection to 09:45
` form. Scope. 09:45
` You can answer. 09:45
` A. I'm not sure what you mean. I'm 09:45
`not sure what you mean. 09:45
` Q. So my question is about what you 09:45
`meant. You just said depending on the 09:45
`context, alleviating relapses may be 09:45
`something different in speaking to a 09:45
`patient. It might mean one thing, but in 09:45
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` L. Steinman, M.D.
`this context presumably referring to your 09:45
`deposition or this case, it might mean 09:45
`another thing. 09:46
` So I'm asking about your 09:46
`understanding of what alleviating relapses 09:46
`means in the context of this case? 09:46
` MR. TRENCHARD: Objection to 09:46
` form. Scope. 09:46
` You can answer. 09:46
` A. Just to put one thing on the 09:46
`table before I talk about alleviate, the 09:46
`word prevent in my mind is much easier. 09:46
`Prevent would be stop the next one and the 09:46
`one after that and the one after that. So 09:46
`that's easier. 09:46
` Alleviate, again, it has some 09:46
`potential meanings. One is prevent. 09:46
`Another is to make a relapse milder. And 09:46
`there may be other definitions. 09:46
` But again, I'm only talking 09:46
`about it in the context of the question 09:46
`you just asked, not about a word that 09:46
`might be in, construed in a different 09:47
`format in a related issue. 09:47
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` L. Steinman, M.D.
` But I'm just talking about the 09:47
`word in response to your question as I see 09:47
`it at the moment, and it's somewhat 09:47
`different as I mentioned than what I might 09:47
`say to a patient in a room. I wouldn't be 09:47
`talking like this anyway to a patient in a 09:47
`room. I would try to be soothing and I 09:47
`would try to be comforting and healing. 09:47
` So the differences are quite 09:47
`important, but I just would say that 09:47
`"prevent" is easy. "Alleviate" has many 09:47
`complexities. 09:47
` Q. I won't object to you being 09:47
`soothing and comforting during the 09:47
`deposition. You don't have to be rough 09:48
`and tumble, as an attempt to humor. I 09:48
`apologize if it didn't come over right. 09:48
` A. I want to be precise and 09:48
`accurate and responsive to the context. 09:48
`So I'm not trying to be anything other 09:48
`than that. 09:48
` Q. I appreciate that, and I'm going 09:48
`to try to be precise and use the words as 09:48
`you understand them in the context of this 09:48
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` L. Steinman, M.D.
`proceeding, so I want to make sure I 09:48
`understand what you've said, which is that 09:48
`in the context of this proceeding, the 09:48
`term "alleviating relapses" can include 09:48
`preventing relapses as well as lessening 09:48
`the severity of relapses, is that correct? 09:48
` MR. TRENCHARD: Objection to 09:48
` form and scope. 09:48
` You can answer. 09:48
` A. First, I think that's what I 09:48
`just said. 09:48
` And second, I also said if the 09:48
`term happens to be in some other 09:48
`formality, construed somewhat differently, 09:48
`I'm not talking about such a formality. 09:49
`I'm just talking about the language as you 09:49
`presented the question. 09:49
` Q. We're talking about the term as 09:49
`it applies in this proceeding, correct? 09:49
` MR. TRENCHARD