`
`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
` JEROLD CHUN, M.D., Ph.D.,
` New York, New York
` April 9, 2018
`
`Reported by:
`Linda Salzman
`JOB NO. 140363
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`APOTEX ET AL. - EXHIBIT 1063
`Apotex Inc. et al. v. Novartis AG
`IPR2017-00854
`
`
`
`Page 2
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` April 9, 2018
` 9:00 a.m.
`
` Videotaped Deposition of JEROLD
` CHUN, M.D., Ph.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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`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.
`
` 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. 08:24
` This is the start of DVD No. 1 09:03
` of the video-recorded deposition of 09:03
` JEROLD CHUN, M.D., Ph.D., in the 09:03
` matter of Apotex Inc., et al., versus 09:03
` Novartis A.G., in the United States 09:03
` Patent and Trademark Office, before 09:03
` the Patent Trial and Appeal Board. 09:03
` This deposition is being held at 09:03
` Gibson Dunn, 200 Park Avenue, New 09:03
` York, New York, on April 9, 2018 at 09:03
` approximately 9:03 a.m. 09:03
` My name is Larry Moskowitz. I'm 09:03
` the legal video specialist from TSG 09:03
` Reporting, headquartered at 747 Third 09:03
` Avenue, New York, New York. The court 09:03
` reporter is Linda Salzman, also in 09:03
` association with TSG Reporting. 09:03
` Will counsel please introduce 09:04
` themselves for the record. 09:04
` MR. MILLS: My name is Jad 09:04
` Mills. I'm with the law firm of 09:04
` Wilson Sonsini Goodrich & Rosati. I 09:04
` represent Apotex Inc. and Apotex 09:04
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` Corp., Petitioners in this matter. 09:04
` MR. TRENCHARD: Robert 09:04
` Trenchard, and with me is my partner, 09:04
` Jane Love. We're from Gibson Dunn, 09:04
` and we represent the Patent Owner, 09:04
` Novartis. 09:04
` THE VIDEOGRAPHER: Will the 09:04
` reporter please administer the oath. 09:04
`J E R O L D C H U N,
` called as a witness, having been duly
` sworn by a Notary Public, was examined
` and testified as follows:
`EXAMINATION BY
`MR. MILLS: 09:04
` Q. Good morning, Dr. Chun. 09:04
` A. Good morning. 09:04
` Q. Is this your first deposition? 09:04
` A. Yes. 09:04
` Q. Okay. So I'm going to spend a 09:04
`fair amount of time talking through the 09:04
`process to make sure you understand the 09:04
`way it works and what the rules are so 09:04
`that everyone is comfortable with what's 09:04
`happening today. 09:04
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` J. Chun, M.D., Ph.D.
` A. Thank you. 09:04
` Q. So in a deposition, you just 09:05
`took an oath so you're under oath, the 09:05
`same as you would be if you were in open 09:05
`court in front of a judge. 09:05
` Do you understand that? 09:05
` A. Yes. 09:05
` Q. The way that it works is the 09:05
`court reporter is diligently working to 09:05
`take down every word that you or I or 09:05
`anyone else in the room says. And so we 09:05
`need to be very careful not to speak over 09:05
`one another. And also do our best not to 09:05
`speak too quickly so that she has a tough 09:05
`time taking down the words. 09:05
` Do you understand that? 09:05
` A. Understood. 09:05
` Q. It's also very important that 09:05
`you answer the questions posed to you 09:05
`using an audible response such as "yes" or 09:05
`"no." We don't want any grunts or nodding 09:05
`of head, simply because the court reporter 09:05
`can't put that in the transcript very 09:05
`easily. 09:05
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` J. Chun, M.D., Ph.D.
` A. Understood. 09:05
` Q. Thank you. 09:05
` We want to make sure that 09:06
`there's no confusion about what we're 09:06
`talking about at any point, so if at any 09:06
`point I ask a question and you don't 09:06
`understand what my question is, the 09:06
`expectation is that you will ask for 09:06
`clarification so that we can make sure we 09:06
`understand one another. 09:06
` Do you agree with that? 09:06
` A. Yes. 09:06
` Q. So if you don't ask for 09:06
`clarification, then we will all assume 09:06
`that you understood the question. 09:06
` A. Okay. 09:06
` Q. Okay. 09:06
` If, at any time, your attorney 09:06
`makes an objection -- you know what an 09:06
`objection is? 09:06
` A. Yes. 09:06
` Q. So if he says the word 09:06
`"objection" or begins to speak, that does 09:06
`not relieve you of your obligation to 09:06
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` J. Chun, M.D., Ph.D.
`answer the question that I've posed to 09:06
`you. 09:06
` Understand? 09:06
` A. Understood. 09:06
` Q. During the deposition, you're 09:06
`not supposed to discuss with Novartis's 09:06
`attorneys anything having to do with the 09:07
`case or your testimony today. 09:07
` Do you understand that? 09:07
` A. Understood. 09:07
` Q. And if you do have any 09:07
`discussions with the attorneys that 09:07
`relates to the case or your testimony in 09:07
`any way, then you will have to tell me 09:07
`about what it was that you talked about. 09:07
` Do you understand that? 09:07
` A. Understood. 09:07
` Q. You understand that I represent 09:07
`Apotex Inc. and Apotex Corp.? 09:07
` A. I do now. 09:07
` Q. And those are two of the 09:07
`petitioners in this IPR proceeding. 09:07
` A. Okay. 09:07
` Q. Do you know what an IPR 09:07
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`proceeding is? 09:07
` A. Would you explain that to me, 09:07
`please? 09:07
` Q. This is just to make sure there 09:07
`isn't confusion when we use the word IPR. 09:07
`So an IPR proceeding is an administrative 09:07
`challenge to the validity of a patent that 09:07
`takes place before the Patent Office. 09:07
` A. Okay. 09:07
` Q. Does that explanation make sense 09:07
`to you? 09:07
` A. Yes. 09:07
` Q. Are you familiar generally with 09:07
`the concept of a patent? 09:08
` A. Yes. 09:08
` Q. How are you familiar with the 09:08
`concept of a patent, just generally? 09:08
` A. I've been involved with making 09:08
`patents. 09:08
` Q. Okay. Have you ever been 09:08
`involved in a -- let me withdraw that 09:08
`question and start over. 09:08
` When you say you've been 09:08
`involved in making patents, does that mean 09:08
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` J. Chun, M.D., Ph.D.
`you applied for a patent in the past for 09:08
`one of your inventions? 09:08
` A. Yes. 09:08
` Q. And do you understand that the 09:08
`process of applying for a patent and going 09:08
`back and forth with the Patent Office to 09:08
`obtain a patent is called patent 09:08
`prosecution? 09:08
` A. I do now. 09:08
` Q. You recall that process from 09:08
`your own patents, correct? 09:08
` A. Correct. 09:08
` Q. Approximately how many patents 09:08
`have you applied for during your career? 09:08
` A. Approximately five. 09:09
` Q. And did you apply for all of 09:09
`those patents when you were employed at 09:09
`Scripps? 09:09
` A. No. 09:09
` Q. When I use the word "Scripps," 09:09
`do you know what I mean when I say that? 09:09
` A. I believe so. 09:09
` Q. Go ahead and tell me what you 09:09
`understand when I talk about your 09:09
`
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` J. Chun, M.D., Ph.D.
`employment at Scripps. 09:09
` MR. TRENCHARD: Objection to 09:09
` form. 09:09
` You can answer. 09:09
` A. The Scripps Research Institute. 09:09
` Q. And where is the Scripps 09:09
`Research Institute located? 09:09
` A. La Jolla, California. 09:09
` Q. So is it okay during the 09:09
`deposition when we use the word "Scripps" 09:09
`that's what we're referring to? Does that 09:09
`make sense? 09:09
` A. Absolutely. 09:09
` Q. Were any of the five patents for 09:09
`which you applied applied for based on 09:09
`your work for Scripps? 09:10
` A. Yes. 09:10
` Q. How many? 09:10
` A. Two perhaps. 09:10
` Q. So for the other three, where 09:10
`were you employed when you conducted the 09:10
`work that led to those other three 09:10
`patents? 09:10
` A. One, I believe, was at the 09:10
`
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`University of California San Diego, and 09:10
`one or two were at Sanford Burnham Prebys 09:10
`Medical Discovery Institute. 09:10
` Q. And that's Sanford -- 09:10
` A. Sanford, correct. 09:10
` Q. And that's your current place of 09:10
`employment, correct? 09:10
` A. Correct. 09:10
` Q. Do you know whether any patents 09:10
`issued for the five applications that you 09:10
`made? 09:10
` MR. TRENCHARD: Objection to 09:11
` form. 09:11
` You can answer. 09:11
` A. Yes. 09:11
` Q. How many patents issued from 09:11
`your five applications? 09:11
` A. I believe there were two that 09:11
`issued. 09:11
` Q. Were those the two that you 09:11
`applied for based on your work at Scripps? 09:11
` A. No. One at UCSD, the University 09:11
`of California San Diego. I can't remember 09:11
`where the other one was issued. 09:11
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` I should add an addendum, which 09:11
`is there may have been patents filed from 09:11
`Merck when I was an employee there, but I 09:11
`don't recall if any were filed, actually 09:11
`filed with my name on it or granted in the 09:11
`company. 09:11
` Q. When were you employed at Merck? 09:11
` A. From approximately 2001 through 09:11
`2003. 09:11
` Q. Can you put any finer time 09:12
`period; a month or a time of year? 09:12
` MR. TRENCHARD: Objection to 09:12
` form. 09:12
` You can answer. 09:12
` A. I don't recall the actual dates. 09:12
` Q. For the UCSD patent that issued, 09:12
`generally what was the subject matter of 09:12
`that patent? 09:12
` A. Lysophospholipid receptors. 09:12
` Q. Is S1P1 an example of a 09:12
`lysophospholipid receptor? 09:12
` A. Correct. 09:12
` Q. And Dr. Chun, you are a 09:12
`discoverer of the lysophospholipid 09:12
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`receptors, correct? 09:13
` MR. TRENCHARD: Objection to 09:13
` form and scope. 09:13
` You can answer. 09:13
` A. Yes. 09:13
` Q. Your discovery of 09:13
`lysophospholipid receptors is an important 09:13
`part of your career, correct? 09:13
` MR. TRENCHARD: Objection to 09:13
` form, scope and relevance. 09:13
` You can answer. 09:13
` A. Correct. 09:13
` Q. It was a major achievement of 09:13
`yours, correct? 09:13
` MR. TRENCHARD: Same three 09:13
` objections. 09:13
` You can answer. 09:13
` A. Correct. 09:13
` Q. Your discovery of 09:13
`lysophospholipid receptors is an example 09:13
`of a major contribution that you 09:13
`personally made to the advancement of 09:13
`science, correct? 09:13
` MR. TRENCHARD: Same three 09:13
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` objections. 09:13
` You can answer. 09:13
` A. Could you clarify that question, 09:13
`please? 09:13
` Q. Which part of the question do 09:14
`you think -- are you having trouble with? 09:14
` MR. TRENCHARD: Same three 09:14
` objections. 09:14
` You can answer. 09:14
` A. Could you please restate the 09:14
`question? 09:14
` Q. Okay. 09:14
` So my question was your 09:14
`discovery of lysophospholipid receptors is 09:14
`an example of a major contribution that 09:14
`you personally made to the advancement of 09:14
`science, correct? 09:14
` MR. TRENCHARD: Objection to 09:14
` form, scope and relevance. 09:14
` You can answer. 09:14
` A. Yes. 09:14
` Q. It was a pretty big deal, right? 09:14
` MR. TRENCHARD: Same three 09:14
` objections. 09:14
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` You can answer. 09:14
` A. It's science. 09:14
` Q. And your contribution to science 09:14
`was a big deal in the advancements of 09:14
`science, correct? 09:14
` MR. TRENCHARD: Objection. Same 09:14
` three objections; form, scope and 09:14
` relevance. 09:14
` You can answer. 09:14
` A. It contributed to science. 09:14
` Q. You agree, Dr. Chun, that many 09:14
`trees have died publishing papers based on 09:15
`your work with phospholipid receptors, 09:15
`correct? 09:15
` MR. TRENCHARD: Objection to 09:15
` form. 09:15
` You can answer. 09:15
` A. No. 09:15
` Q. Okay. Go ahead and tell me 09:15
`what's wrong with the statement. 09:15
` MR. TRENCHARD: Same three 09:15
` objections. 09:15
` You can answer. 09:15
` A. Electronic publication does not 09:15
`
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`kill trees. 09:15
` Q. Okay. So you would agree with 09:15
`me that you personally have many 09:15
`publications based on your work with 09:15
`lysophospholipid receptors, correct? 09:15
` MR. TRENCHARD: Objection to 09:15
` form, scope and relevance. 09:15
` You can answer. 09:15
` A. I have published in this field. 09:15
` Q. Approximately how many 09:15
`publications have you published based on 09:15
`your work with lysophospholipid receptors? 09:16
` A. Approximately 100 to 200. 09:16
` Q. Approximately what is your total 09:16
`publication count? 09:16
` A. Approximately 300. 09:16
` Q. So you would agree that between 09:16
`one-third and two-thirds of your personal 09:16
`body of scientific work is directed to 09:16
`your work on lysophospholipid receptors, 09:16
`correct? 09:16
` MR. TRENCHARD: Objection to 09:16
` form, scope and relevance. 09:16
` You can answer. 09:16
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` A. It involves that area of study. 09:16
` Q. Approximately what percentage of 09:16
`your publications are directed 09:17
`specifically to S1P receptors? 09:17
` MR. TRENCHARD: Objection to 09:17
` form, scope and relevance. You can 09:17
` answer. 09:17
` A. Approximately one-fourth of 09:17
`those dealing with lysophospholipid 09:17
`receptors. 09:17
` Q. And of the other three-quarters, 09:17
`what generally was their subject matter? 09:17
` MR. TRENCHARD: Objection to 09:17
` form, scope and relevance. 09:17
` You can answer. 09:17
` A. Other lysophospholipid 09:17
`receptors. 09:17
` Q. Can you please list for me all 09:17
`lysophospholipid receptors about which 09:17
`you've published more frequently than S1P 09:17
`receptors? 09:17
` MR. TRENCHARD: Objection to 09:17
` form, scope and relevance. 09:17
` You can answer. 09:17
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` A. Lysophosphatidic acid receptor 09:17
`1, or LPA1, LPA2, LPA3, LPA4, LPA5, LPA6. 09:18
` And in addition, other receptors 09:18
`that have been reported in the literature, 09:18
`LPI, LPS1, LPS2, LPS3, and there may be 09:18
`one or two others that are in that group. 09:19
` Q. Dr. Chun, that group of LPA1 09:19
`through LPA6, and LPI and LPS1 through 3, 09:19
`are you saying that as a group your 09:19
`publications about those receptors make up 09:19
`a greater percentage of your publications 09:19
`than the S1P receptor or that each 09:19
`individual one does? 09:19
` MR. TRENCHARD: Objection to 09:19
` form, scope and relevance. 09:19
` A. Please restate the question. 09:19
` Q. So originally my question was 09:19
`one-quarter of your lysophospholipid 09:20
`receptor publications are about S1P. So 09:20
`is there any other lysophospholipid 09:20
`receptor which you published more 09:20
`frequently than S1Ps? 09:20
` MR. TRENCHARD: Objection to 09:20
` form, scope and relevance. 09:20
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` You can answer. 09:20
` A. That list that I gave you 09:20
`constitutes the other receptors. 09:20
` Q. So that list of 10 receptors is 09:20
`the other 75 percent? 09:20
` A. Approximately. 09:20
` Q. And I won't hold you to a high 09:20
`degree of precision on the percentage of 09:20
`publications, we're just trying to get a 09:20
`sense. 09:20
` Of those 10 receptors, how many 09:20
`of them constitute the subject matter of 09:20
`more than 25 percent of your 09:20
`lysophospholipid receptor publications? 09:21
` MR. TRENCHARD: Objection to 09:21
` form, scope and relevance. 09:21
` You can answer. 09:21
` A. Approximately 25 percent, was 09:21
`that the question? 09:21
` Q. So do any of those 10 exceed the 09:21
`25 percent threshold that applies to S1P? 09:21
` MR. TRENCHARD: Objection to 09:21
` form, scope and relevance. 09:21
` A. I'm not sure. Possibly LPA1. 09:21
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` Q. Of those 10 other phospholipid 09:21
`receptors that you have identified, has 09:21
`your work on those receptors led to the 09:21
`FDA approval of a new drug? 09:21
` MR. TRENCHARD: Objection to 09:22
` form, scope and relevance. 09:22
` You can answer. 09:22
` A. Would you clarify "FDA 09:22
`approval"? 09:22
` Q. Let me ask you, what's your 09:22
`understanding of the phrase "FDA 09:22
`approval"? 09:22
` MR. TRENCHARD: Same objections. 09:22
` You can answer. 09:22
` A. Do you mean has become an 09:22
`FDA-approved medicine, or do you mean FDA 09:22
`has approved some stage of clinical work? 09:22
` Q. So let's start with the first 09:22
`definition, where there's a marketing 09:22
`approval from FDA. 09:22
` MR. TRENCHARD: Same objections. 09:22
` You can answer. 09:22
` A. None have been approved. 09:22
` Q. With regard to your work on S1P 09:22
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`receptors, has that resulted in the FDA 09:22
`approval of any medicines? 09:22
` MR. TRENCHARD: Objection to 09:22
` form, scope and relevance. 09:23
` You can answer. 09:23
` A. Yes. 09:23
` Q. How many medicines? 09:23
` MR. TRENCHARD: Same objections. 09:23
` You can answer. 09:23
` A. One. 09:23
` Q. And what medicine is that? 09:23
` MR. TRENCHARD: Same objections. 09:23
` You can answer. 09:23
` A. Fingolimod, also known as 09:23
`FTY720. 09:23
` Q. Other than Fingolimod, is there 09:23
`any other FDA -- any other medicine that's 09:23
`been approved by the FDA that was 09:23
`developed based on your work? 09:23
` MR. TRENCHARD: Objection to 09:23
` form, scope and relevance. 09:23
` You can answer. 09:23
` A. Could you clarify that? By my 09:23
`"work," are you referring to 09:23
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`lysophospholipid receptors or something 09:23
`else? 09:23
` Q. Thank you for asking for that 09:23
`clarification. Let's begin with 09:23
`lysophospholipid receptors. 09:23
` MR. TRENCHARD: Same objections. 09:23
` You can answer. 09:24
` A. Not to my knowledge. 09:24
` Q. Approximately what percentage of 09:24
`your publications -- that was the 1 to 200 09:24
`was lysophospholipid receptors? 09:24
` MR. TRENCHARD: Objection to 09:24
` form. 09:24
` A. Correct. 09:24
` Q. Dr. Chun, is it correct that 09:24
`your involvement in the FDA approval of 09:24
`Fingolimod was limited to the basic 09:24
`scientific research into S1P receptors? 09:24
` MR. TRENCHARD: Objection to 09:24
` form, scope and relevance. 09:24
` You can answer. 09:24
` A. Correct. 09:24
` Q. Other than performing basic 09:25
`research that ultimately resulted in 09:25
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`Fingolimod, did you have any involvement 09:25
`in preclinical trials for Fingolimod? 09:25
` MR. TRENCHARD: Objection to 09:25
` form, scope and relevance. 09:25
` You can answer. 09:25
` A. No. 09:25
` Q. Did you have any involvement in 09:25
`human clinical trials for Fingolimod? 09:25
` A. No. 09:25
` Q. Dr. Chun, have you had any 09:25
`involvement with postmarketing and 09:25
`commercial activities of Fingolimod? 09:25
` MR. TRENCHARD: Objection to 09:25
` form, scope and relevance. 09:25
` You can answer. 09:25
` A. Would you clarify 09:25
`"postmarketing"? 09:25
` Q. Yeah, and I'll actually tell you 09:26
`what I'm talking about, because I'm a 09:26
`little confused based on your answers just 09:26
`now. 09:26
` So I'm reading from your CV. 09:26
`And it says, referring to Dr. Chun, "He 09:26
`participated in all major stages of the 09:26
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`development of Fingolimod (Gilenya, 09:26
`Novartis) from basic science, preclinical 09:26
`studies through postmarketing and 09:26
`commercial activities." 09:26
` A. Correct. 09:26
` Q. So it's true that you 09:26
`participated in all major stages of the 09:26
`development of Fingolimod? 09:26
` MR. TRENCHARD: Objection to 09:26
` form, scope and relevance. 09:26
` You can answer. 09:26
` A. Would you restate that question, 09:26
`please? 09:26
` Q. It's true that you participated 09:26
`in all major stages of the development of 09:26
`Fingolimod? 09:26
` MR. TRENCHARD: Objection to 09:27
` form, scope and relevance. 09:27
` You can answer. 09:27
` A. "Participated" is correct. 09:27
` Q. Is it correct that you 09:27
`participated in the human clinical trials 09:27
`of Fingolimod? 09:27
` MR. TRENCHARD: Same objections. 09:27
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` You can answer. 09:27
` A. Participated as distinguished 09:27
`from actually conducting. Are you making 09:27
`that distinction? 09:27
` Q. Well, I'm just trying to find 09:27
`out what the distinction is, so why don't 09:27
`you go ahead and tell me what the 09:27
`distinction is -- so go ahead and tell me 09:27
`what distinction you're making. 09:27
` A. Participation means everything 09:27
`from discussion to, in the case of 09:27
`preclinical basic science work, actually 09:27
`conducting work. But it's a very broad 09:28
`term. 09:28
` Q. Is it correct that your only 09:28
`scientific work regarding the development 09:28
`of Fingolimod occurred at the preclinical 09:28
`stage? 09:28
` MR. TRENCHARD: Objection to 09:28
` form, scope and relevance. 09:28
`