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`Exhibit 1055
`Slayback v. Sumitomo
`IPR2020-1053
`
`(cid:21)(cid:20)(cid:21)(cid:16)(cid:21)(cid:26)(cid:28)(cid:16)(cid:28)(cid:23)(cid:21)(cid:23)
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`(cid:57)(cid:72)(cid:85)(cid:76)(cid:87)(cid:72)(cid:91)(cid:87)(cid:3)(cid:47)(cid:72)(cid:74)(cid:68)(cid:79)(cid:3)(cid:54)(cid:82)(cid:79)(cid:88)(cid:87)(cid:76)(cid:82)(cid:81)(cid:86)
`(cid:90)(cid:90)(cid:90)(cid:17)(cid:89)(cid:72)(cid:85)(cid:76)(cid:87)(cid:72)(cid:91)(cid:87)(cid:17)(cid:70)(cid:82)(cid:80)
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`(cid:21)(cid:20)(cid:21)(cid:16)(cid:23)(cid:28)(cid:19)(cid:16)(cid:22)(cid:23)(cid:22)(cid:19)
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`Exhibit 1055
`Slayback v. Sumitomo
`IPR2020-1053
`
`(cid:21)(cid:20)(cid:21)(cid:16)(cid:21)(cid:26)(cid:28)(cid:16)(cid:28)(cid:23)(cid:21)(cid:23)
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`(cid:57)(cid:72)(cid:85)(cid:76)(cid:87)(cid:72)(cid:91)(cid:87)(cid:3)(cid:47)(cid:72)(cid:74)(cid:68)(cid:79)(cid:3)(cid:54)(cid:82)(cid:79)(cid:88)(cid:87)(cid:76)(cid:82)(cid:81)(cid:86)
`(cid:90)(cid:90)(cid:90)(cid:17)(cid:89)(cid:72)(cid:85)(cid:76)(cid:87)(cid:72)(cid:91)(cid:87)(cid:17)(cid:70)(cid:82)(cid:80)
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`(cid:21)(cid:20)(cid:21)(cid:16)(cid:23)(cid:28)(cid:19)(cid:16)(cid:22)(cid:23)(cid:22)(cid:19)
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`Page 2
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` UNITED STATES PATENT AND TRADEMARK OFFICE
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`SLAYBACK PHARMA, LLC PETITIONER
`
`V. CASE NO. IPR2020-01053
`
`SUMITOMO DAINIPPON PHARMA, CO., LTD. PATENT OWNER
`
` DEPOSITION OF BRIAN REISETTER, PH.D.
`
`Taken at the instance of the Petitioner on Thursday,
`April 29, 2021, by videoconference via Zoom, all parties
` attending via Zoom, beginning at 9:01 a.m.
`
` (Appearances noted herein)
`
`REPORTED BY: Courtney R. Taylor, CCR, TLC
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`212-279-9424
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`APPEARANCES:
`
` LOUIS H. WEINSTEIN, ESQ.
` Windels, Marx, Lane & Mittendorf, LLP
` One Giralda Farms
` Madison, New Jersey 07940
` COUNSEL FOR PETITIONER
`
` MICHAEL J. KANE, ESQ.
` Fish & Richardson, P.C.
` 3200 RBC Plaza
` 60 South Sixth Street
` Minneapolis, Minnesota 55402
` COUNSEL FOR PATENT OWNER
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` INDEX
`Style and Appearances................................ 1-2
`Index................................................ 3
`Examination by Mr. Weinstein......................... 5
` Exhibit 2132.................................... 8
` Exhibit 1001.................................... 21
` Exhibit 1009.................................... 42
` Exhibit 2131.................................... 44
` Exhibit 2077.................................... 56
` Exhibit 2069.................................... 62
`Certificate of Reporter.............................. 84
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` BRIAN REISETTER, PH.D.,
` having first been duly sworn, was examined and
`testified as follows:
`EXAMINATION BY MR. WEINSTEIN:
` Q. Good morning, Dr. Reisetter.
` A. Good morning.
` Q. Are you ready for me to start asking questions?
` A. Sure.
` Q. Could you please state your name for the record?
` A. Brian Reisetter.
` Q. My name is Louis Weinstein, and I represent
`Slayback in this proceeding.
` You understand that it's my job to ask you
`questions, and it's your job to answer them truthfully, if
`you can?
` A. Yes.
` Q. If I give you a fair question, will you do your
`best to give me a fair and honest answer?
` A. Yes, I will.
` Q. Is there any medical reason preventing you from
`hearing, understanding, and giving answers to my questions
`today?
` A. No.
` Q. You understand that you are under oath to tell
`the truth?
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` A. Yes, I do.
` Q. Do you take that oath seriously?
` A. Yes.
` Q. Do you understand that we are here today as
`part of something called an inter Partes Review?
` A. Yes.
` Q. If I say "IPR," will you understand that to
`mean Inter Partes Review?
` A. Yes.
` Q. And if I say "this case," will you
`understand that what I mean is this Inter Partes
`Review?
` A. Yes.
` Q. I'm going to try to mark your declaration
`in this case. It should be in your -- well, do you
`have a binder of paper?
` A. Here's what I've got (indicating), and I
`haven't opened it yet.
` Q. Would you please open that, and I'm -- you
`might need something sharp.
` A. Let me -- all right. That's what I got
`(indicating).
` Q. Okay. Thank you.
` Is anybody in the room with you right now,
`or are you by yourself?
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` A. I'm by myself.
` Q. Do you have any materials related to this
`case in the room, other than the binder, which you
`just opened?
` A. Yes, I do, but I don't have access to them.
`They're in the room.
` Q. Okay. Are you planning on looking at them
`during the deposition?
` A. No, I can put them away, if you'd like.
` Q. No problem.
` A. I don't plan on it.
` Q. Do you recall -- oh, let's turn to that
`binder, and do you see how it has Exhibit Tabs A
`through I?
` A. Yes.
` Q. That's just for convenience. If I ask you
`for Tab A, you would go to Exhibit A in the binder,
`and Exhibit H in the binder, that's a tab. But the
`exhibits are all going to be numbers.
` So in your big binder, would you please go
`to Tab I? And it's at the end.
` And can you tell me if you see, at least on
`the first page, it says, "Declaration of Brian C.
`Reisetter, RPh, MBA, and Ph.D., protective order
`materials."
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` A. Yes.
` Q. Do you have that?
` A. Yes.
` Q. Okay. That is going to be Exhibit 2132,
`and I'm going to try to mark that for the court
`reporter here. And please bear with me as I try to
`do that.
` So -- so let's see. Okay. And I'm not
`going to put a stamp on this, but it is going to be
`Exhibit -- well, 2132 -- I'll try to put a stamp on
`it. We'll see what happens.
` (Exhibit 2132 marked for identification and
` attached hereto.)
` Q. (By Mr. Weinstein) Okay. So it says that
`the exhibit has been introduced. Unfortunately, the
`little tag went in a bad place. If you -- so that's
`basically just for the court reporter's -- so that
`she has that.
` So, Dr. Reisetter, do you recall preparing
`a declaration in this case?
` A. Yes.
` Q. Does Exhibit 2132, at least from the first
`page, appear to be that declaration?
` A. Yes.
` Q. Okay. Can you turn to the signature
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`page -- oh, can we call this your declaration in
`this case?
` A. Yes, this is my declaration.
` Q. So can you please turn to your declaration
`in this case. It has -- towards the back, it has
`two page numbers, 28 and 30, and it has your
`signature.
` Do you have that page?
` A. Yes.
` Q. So I'm going to use the bottom number, is
`page 30.
` So your signature is on that page, correct?
` A. Yes.
` Q. And you signed that on March 11, 2021?
` A. Yes.
` Q. Okay. When was the last time that you read
`your declaration in this case, Exhibit 2132?
` A. This morning.
` Q. Are all of your opinions in this case
`contained in your declaration, Exhibit 2132?
` A. Yes, or everything that I've been asked to
`do to-date, yes.
` Q. Okay. So to-date, have you formed any
`additional opinions in this case, other than those
`that are recorded in your declaration in this case?
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` A. Not that I can think of, no.
` Q. If I say EX 2132, will you understand that
`to be Exhibit 2132?
` A. Okay. Sure.
` Q. Okay. And that's with all the exhibits,
`sometimes I might say "EX," and what I really mean
`is exhibit.
` Is there anything that you want to change
`in your declaration in this case?
` A. No.
` Q. So still sticking with Exhibit 2132, can
`you please go to what would be page 31, at the
`bottom, Appendix A?
` Do you have that --
` A. Yes.
` Q. -- page?
` And, if you turn to the page, does that
`start your curriculum vitae?
` A. Yes, it does.
` Q. Are you a licensed pharmacist?
` A. Yes.
` Q. Okay. To become a pharmacist, you had to
`take chemistry courses?
` A. Yes.
` Q. Did you take organic chemistry courses?
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` A. Yes, 40 years ago.
` Q. In becoming a pharmacist, did you acquire
`at least a general understanding of the term
`"pharmaceutical salt"?
` A. Yes.
` Q. What do you understand pharmaceutical salt
`to mean?
` A. In what context?
` Q. In the context of a marketed drug.
` MR. KANE: Objection; vague.
` A. Yeah, I would need to know -- I would need
`to know what you're talking about.
` Q. (By Mr. Weinstein) Okay. In becoming a
`pharmacist, did you acquire at least a general
`understanding of the term "freebase"?
` A. Yes.
` Q. Okay. In becoming a pharmacist, did you
`acquire at least a general understanding that in
`some pharmaceutical products, the active
`pharmaceutical ingredient is a freebase?
` MR. KANE: Objection; vague.
` A. Yes, these definitions are in the orange
`book. I would rely on the orange book to provide
`any additional information.
` Q. (By Mr. Weinstein) You're familiar with
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`Page 12
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`the orange book?
` A. Yes.
` Q. Are you aware that an active pharmaceutical
`ingredient can be a salt of a freebase?
` MR. KANE: Objection; calls for a legal
` conclusion.
` A. I know it's possible, but I would need to
`know a context. I don't understand in what context
`relates to this case, I guess.
` Q. Okay. Have you ever heard of Latuda®?
` A. Yes.
` Q. Do you know what the active pharmaceutical
`ingredient of Latuda® is?
` A. It's lurasidone.
` Q. Could you please turn to paragraph 26 of
`your declaration in this case? And tell me when
`you're there.
` It's page 11 on the bottom, paragraph 26.
` Do you have that?
` A. On page -- on the bottom, number 11,
`paragraph 26, starts, "Latuda®"?
` Q. Yes.
` You have that?
` A. Yes, I do.
` Q. And then parentheses it says, "lurasidone
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`hydrochloride," right?
` A. Yes.
` Q. Why did you put the term "hydrochloride" in
`parentheses there?
` A. I believe that's the way it's listed in the
`package insert. That is it's salt. Its chemical
`structure, its chemical name, I should say.
` Q. The active ingredient in
`Latuda® is lurasidone hydrochloride?
` A. That's my understanding. Yes.
` Q. A few minutes ago, you said the active
`ingredient was lurasidone, so did you really mean
`lurasidone hydrochloride?
` A. To be more specific, yes. I mean, in
`vernacular for pharmacy, I would have -- if somebody
`said, "What's the generic name of Latuda," I
`probably would have said lurasidone. If I looked in
`the package insert, it's lurasidone hydrochloride.
` But once you're -- this is why I asked for
`context. It depends on what you're asking me, how I
`would answer that question.
` Q. Okay. So that's good.
` So you understand the active pharmaceutical
`ingredient of Latuda® is lurasidone hydrochloride,
`correct?
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` A. Yes.
` Q. And you understand that lurasidone
`hydrochloride is the hydrochloride of the freebase
`known as lurasidone, correct?
` A. That's my understanding, yes.
` Q. Okay. Are you aware of any marketed
`pharmaceutical product that has lurasidone freebase
`as its active pharmaceutical ingredient?
` A. As far as I'm aware, there are none on the
`market currently, but I haven't researched that. I
`don't know for sure, but that is my understanding.
` Q. All right. In your declaration in this
`case, could you please go to what you called
`Appendix C, which begins at page 40.
` Do you have that Appendix C?
` A. Yes.
` Q. At the top of page 41 of Appendix C, it
`says, "Materials considered," correct?
` A. Yes.
` Q. Does Appendix C list all of the materials
`you considered in forming your opinions in this
`case?
` A. Yes.
` Q. Did you identify any of the materials in
`Appendix C before they were identified to you by
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`counsel in this case?
` MR. KANE: Objection; vague.
` A. Yeah, I would have to go through and look
`item by item.
` Q. (By Mr. Weinstein) Well, it's not that
`long.
` A. But I --
` Q. I think it's about four pages.
` Could you go through and tell me the items
`that you identified for yourself before being
`identified for you by counsel?
` A. Oh, boy, I don't remember, because we've
`worked on IPRs previously, and I did quite a bit of
`research originally. So probably most of the
`peer-reviewed articles, I would have found myself.
` So the types of things that they would have
`provided for me would have been things I requested,
`which are like the marketing materials. I asked for
`brand plans and ATU studies and strategic planning
`and launch plans, and those are the type of things
`that they would have provided for me. So that'd be
`my answer.
` I think there's a couple of the newer
`articles that were included in the marketing
`materials, because they were approved for marketing
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`Page 16
`by the company. For example, that in 2084, 2085, I
`know that was -- and I think 2087, too.
` But the rest of that, it's my recollection
`that I would have found myself.
` Q. Is it fair to say that anything that you
`thought you needed to form your opinions, in this
`case, you either obtained for yourself or obtained
`through counsel?
` A. Yes.
` Q. Okay. Without going into details, could
`you answer me "yes" or "no," if you did anything to
`prepare for this deposition?
` A. Yes.
` Q. And without any, you know, privileged or
`confidential details, can you tell me in general
`what you did to prepare for this deposition, please?
` A. Yesterday, I spent about six or seven
`hours, I would imagine, going over the previous --
`I'm sorry -- the exhibits, along with the report
`that I submitted. That's about it.
` Q. Who did you work with to prepare for this
`deposition?
` A. Mr. --
` MR. KANE: Obj- --
` A. -- Kane.
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` MR. KANE: -ect to the form.
` A. -- Mr. Kane spent about an hour and a half
`with me of that six or seven hours.
` Q. (By Mr. Weinstein) Did you prepare with
`anybody else for this deposition?
` A. No.
` Q. Okay. Did you work with anybody to prepare
`your declaration, Exhibit 2132?
` A. Yes.
` Q. And who did you work with to prepare your
`declaration, Exhibit 2132?
` A. Megan was her first name. Sharon (sic), I
`believe is her last name.
` MR. KANE: It's Chacon, C-H-A-C-O-N.
` Q. (By Mr. Weinstein) Did you work with Chad
`Shear to prepare your declaration?
` A. No, I had a couple of conversations with
`him originally, but I -- but not to work on any of
`the substance of the report or in preparation.
` Q. Did you work with Dorothy Whelan,
`W-H-E-L-A-N, to prepare your declaration in this
`case?
` A. No.
` Q. Did you work with Michael Kane to prepare
`your declaration in this case?
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` A. No, other than the hour and a half
`yesterday.
` Q. I'm talking about in preparing your
`declaration with a C.
` A. Right. So the answer to that is "no."
`Correct.
` Q. So the only person you worked with to
`prepare your declaration in this case was the woman,
`whose first name was Megan?
` A. Correct.
` Q. Is she an attorney?
` A. Yes.
` Q. Is she an attorney with Fish & Richardson?
` A. Yes.
` Q. Have you worked with Fish & Richardson, any
`of the attorneys there, before you started working
`on this case?
` A. Yes.
` Q. In general terms, what was the nature of
`your work with Fish & Richardson before you started
`working on this case?
` A. Well, I listed in my previous cases, there
`is one case that -- it's another IPR for Latuda®
`that was with Fish & Richardson. I also worked on a
`case with Glaxo regarding a product called of COREG.
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`I did some market research for that case.
` There was one other case, too, and I don't
`remember. It was a while back, but I think I've
`worked on -- this will be the fourth case with them.
` Q. So let me go to the Exhibit B of your
`declaration, and it's page 37. At the bottom, it
`says "Exhibit B."
` Do you have that?
` A. Yes.
` Q. And do you have page 38 of that declaration
`inside of Exhibit B --
` A. Yes --
` Q. -- of Appendix B?
` Excuse me.
` Do you have that page?
` A. Yes.
` Q. Three up from the bottom, the first word is
`"Sumitomo"?
` A. Yes.
` Q. That's a case that you worked on with Fish
`& Richardson, correct?
` A. Yes.
` Q. And that involved the same patent at issue
`in this IPR, correct?
` A. Yes.
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` Q. In coming to your opinions in this case,
`did you look at any of the materials from that
`Sumitomo case?
` MR. KANE: Objection; vague.
` A. I looked at the previous report -- Other
`than that -- and the supporting documents, but,
`other than that, no.
` Q. (By Mr. Weinstein) And that was a report
`that you prepared in that earlier case involving the
`patent at issue in this case?
` A. Yes.
` Q. So you have a copy of that?
` A. Someplace. Electronically. I think I -- I
`looked at it at the very beginning, but I haven't
`looked at it since.
` MR. WEINSTEIN: Okay. Mr. Kane, I'm
` going to ask that you produce that document
` that he reviewed from the earlier case, which
` he called his report.
` MR. KANE: All right. We'll -- I'll
` take that under advisement, yes, Lou.
` Q. (By Mr. Weinstein) What was the nature of
`your opinion in that report in that earlier case?
` A. I remember the topic being commercial
`success. I don't remember a lot of the details.
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` Q. Let's try to mark another exhibit in this
`case -- excuse me. Let's try to introduce another
`exhibit in this case. This will be -- Dr. Reisetter
`if you want to start looking at, it's Tab Exhibit A.
`It's U.S. Patent 9815827, and we're going to call
`that the '827 patent in this case.
` And I'm going to try to introduce it. For
`the court reporter, it's Slayback -- it's going to
`be Exhibit 1001, and I'm going to try to do that.
`And if you'll look at -- at that, Dr. Reisetter,
`while I'm trying to introduce that.
` (Exhibit 1001 marked for identification and
` attached hereto.)
` Q. (By Mr. Weinstein) Okay. I've now
`introduced U.S. Patent 9815827 as Exhibit 1001.
` MR. WEINSTEIN: And, for the record, I'm
` using the same exhibit numbers as they were
` filed with the patent office.
` Q. (By Mr. Weinstein) Dr. Reisetter, do you
`have in front of you Exhibit 1001?
` A. Yes.
` Q. And do you understand that to be U.S.
`Patent 9815827?
` A. Yes.
` Q. And may we call that the '827 patent?
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` A. Yes.
` Q. Do you understand that to be the patent
`whose validity is at issue in this case?
` A. Yes.
` Q. And this is the same patent whose validity
`was at issue in that earlier Sumitomo case that we
`just discussed?
` A. Yes. If I'm -- if I'm recalling correctly,
`yes, it should have been.
` Q. Now, let's go to your declaration. I'm
`actually going to go to paragraph 1 of your
`declaration.
` Are you at paragraph 1 of your declaration?
` A. Yes.
` Q. Were you retained as an expert by the
`patent owner in this case to provide your opinions
`on the commercial success of Latuda®?
` A. Yes, that's the second sentence in that
`paragraph.
` Q. And were you retained as an expert by the
`patent owner in this case to provide your opinions
`on the connection between commercial success of
`Latuda® and the claimed inventions of the '827
`patent?
` A. Yes.
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` Q. Can you go to paragraph 23 of your
`declaration, please?
` Can you just read to yourself that
`paragraph 23 and tell me when you're done?
` A. Yes.
` Q. You understand that demonstrating
`commercial success for countering an obvious
`challenge to the '827 patent is one of the issues in
`this case?
` A. Could you say that again?
` Q. Do you understand that demonstrating
`commercial success for countering an obvious
`challenge to the '827 patent is one of the issues in
`this case?
` A. Yes. And I -- that is outlined in
`paragraph 22.
` Q. Okay. In coming to your opinions in this
`case, did you understand that in demonstrating
`commercial success for countering an obvious
`challenge, there must be a nexus between the
`commercial success and the patented features of the
`claimed invention?
` A. Yes. That's verbatim the last of that
`paragraph 23.
` Q. Is lurasidone hydrochloride a claimed
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`feature of the patented invention of the '827
`patent?
` A. I don't have an opinion on that.
` Q. Do you know what the claimed features of
`the '827 patent are?
` A. Well, we could go to the patent and look at
`those, if there's one in particular, but they're
`outlined in -- towards the end of that patent.
` Q. So let's go to that patent. That would be
`your Tab A, Exhibit 1001.
` And do you want to go to column 10 maybe?
`Is that -- is that where you want to start?
` A. Well, that's what I was referring to, is
`items 1 through 75 -- claims 1 through 75, that I
`relied upon Dr. Stahl for his opinions regarding
`those claims and Latuda®.
` Q. Okay. In coming to your opinions in this
`case, did you assume that lurasidone hydrochloride
`was a patented feature of the claimed invention in
`the '827 patent?
` MR. KANE: Objection; vague; calls for a
` legal conclusion.
` A. Yeah, I never considered it either way, and
`I certainly don't have an opinion.
` Q. (By Mr. Weinstein) So you don't know what
`
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`the patented features are of the '827 patent,
`correct?
` A. Again, I know that items 1 through 75 are
`the claims in the patent. That was the previous
`question that you asked. As opposed to -- regarding
`the lurasidone hydrochloride, that being a feature
`of the patent and the definition that you're
`providing, I don't have an opinion on that.
` Q. Okay. So I think you did say that you
`understood there had to be a nexus between the
`commercial success and the patented features of the
`claimed invention, correct?
` A. Yes, I did say that, and that's in that
`paragraph 23.
` Q. And so could you please tell me, in coming
`to your opinions in this case, what exactly did you
`consider the patented features of the claimed
`invention in the '827 patent?
` MR. KANE: Objection; vague.
` A. And as I say in my report, I'm -- I'm
`relying on Dr. Stahl's opinion that the use of
`Latuda® to treat patients falls within those 1
`through 75 claims. Regarding, again, Latuda®
`hydrochloride being a feature, I don't have an
`opinion on that. That's out of my scope.
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`Page 26
` Q. Okay. So you have no opinion as to what is
`or isn't a patented feature of the '827 patent,
`correct?
` A. I have no opinion on your question
`regarding hydro- -- the lurasidone hydrochloride,
`and I certainly don't understand how that would
`affect my opinion of the commercial success of
`Latuda® either way.
` Q. Was -- do you know whether lurasidone
`hydrochloride was a novel feature of the patented
`invention of the '827 patent?
` MR. KANE: Objection; calls for a legal
` conclusion; lack of foundation.
` A. Yeah, I don't have an opinion. Novel --
`whatever you said sounds like there might be a legal
`conclusion. I don't have an opinion.
` Q. (By Mr. Weinstein) Okay. Do you have any
`understanding as to which patented features in the
`'827 patent claims were already in the prior art?
` A. Again, I wouldn't have -- I wouldn't have
`an opinion on that.
` Q. Okay. Have you ever read a patent claim?
` A. I believe so.
` Q. You understand that patent claims have
`elements?
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` A. Yes.
` MR. KANE: Objection; lack of
` foundation.
` A. Yeah. Yeah. Again, I don't know -- I --
`what do you mean by "patent claims"? There are 75
`claims in the back of this patent. I've read those,
`if that's what you're talking about.
` Q. (By Mr. Weinstein) Okay.
` A. There are several different patents, so,
`again, once -- you'll have to help me understand
`your question.
` Q. In general, do you understand that a patent
`claim has elements?
` A. Yes, I understand.
` Q. Do you know the elements of the patent
`claims in the '827 patent?
` A. Again, I'm deferring to Dr. Stahl's opinion
`regarding Latuda®, the treatment of patients with
`Latuda®, falling within the claims within patent
`'827.
` Q. Okay. With respect to your opinions in
`this case, did you consider which patented features
`of the '827 patent were in the prior art and which
`patented features were not in the prior art?
` MR. KANE: Objection; vague; calls for a
`
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`
` legal conclusion.
` A. No, I don't have an opinion on that.
` Q. (By Mr. Weinstein) Okay. So you don't
`know whether lurasidone hydrochloride is in the
`prior art to the '827 patent?
` A. I don't have an opinion either way, whether
`lurasidone hydrochloride is in the prior art.
` Q. Were any methods for treating schizophrenia
`in the prior art to the '827 patent?
` MR. KANE: Objection; vague.
` A. Again, I wouldn't know either way. I don't
`-- I haven't researched that, haven't been asked to
`opine on it. I don't have an opinion.
` Q. (By Mr. Weinstein) Is it true that your
`basic opinion depends on saying that the use of
`Latuda® is covered by the claims of the '827 patent?
` A. I think I specifically state that I'm
`relying on Dr. Stahl's opinion that they fit within
`those claims. My job was to determine whether or
`not Latuda® was a commercial success and that there
`was nexus between those claims in forming that
`opinion.
` Q. Okay. Is it correct that you did not
`consider what was novel in the claims of the '827
`patent in coming to your opinions in this case?
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` Is that correct?
` MR. KANE: Objection; calls for a legal
` conclusion.
` A. Yeah, again, I don't know. It goes back to
`your -- you asked that before about novel
`inventions. I haven't researched that, and I don't
`have an opinion on what that might mean in this
`context.
` Q. (By Mr. Weinstein) So if you go through
`your report, in this -- excuse me. If you go
`through your declaration in this case, there's
`nothing in there about what was new or not new in
`the '827 patent, correct?
` MR. KANE: Objection; vague.
` A. As it relates to the '82 pat- -- '827
`patent, I don't specifically outline the answer to
`that question, and I don't have an opinion on it.
` Q. (By Mr. Weinstein) Okay. I'm going to go
`through these -- I think I know your answer, but I'm
`-- we're just going through it.
` Okay?
` Is lurasidone, as a freebase, a claimed
`feature of the patented invention of the '827
`patent?
` MR. KANE: Objection; and it calls for a
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`
` legal conclusion.
` A. And I did not have an opinion on that.
` Q. (By Mr. Weinstein) Is a pharmaceutically
`acceptable salt of lurasidone a claimed feature of
`the patented invention of the '827 patent?
` MR. KANE: Same objection.
` A. Again, I don't have an opinion on that.
` Q. (By Mr. Weinstein) Okay. Is -- is the
`oral administration of lurasidone hydrochloride a
`claimed feature of the patented invention of the
`'827 patent?
` MR. KANE: Same objection.
` A. Well, it's listed in the claims. Those
`words are listed in the claims, but I don't have an
`opinion on the legalities of it.
` Q. (By Mr. Weinstein) And you don't know
`whether the oral administration of lurasidone
`hydrochloride is a claimed feature of the patented
`invention, correct?
` MR. KANE: Same --
` A. Again --
` MR. KANE: -- obje- --
` A. -- I'm --
` MR. KANE: -- -ction.
` A. -- going to -- I would defer to Dr. Stahl
`
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`
`on that.
` Q. (By Mr. Weinstein) And that's because you
`don't have an opinion on that, correct?
` A. Yes.
` Q. Is a method for treating schizophrenia in a
`patient a claimed feature of the patented invention
`of the '827 patent?
` MR. KANE: Same objection.
` A. And I do not have an opinion on that.
` Q. (By Mr. Weinstein) Can we go to paragraph
`26 of your declaration in this case? It's got page
`11 at the bottom, and it's Exhibit 1001.
` Do you have that paragraph 26?
` A. Of my report, correct?
` Q. Okay. So, just for the record -- and I'm
`sorry to have to do this. You say "my report," that
`means your declaration in this case?
` A. Yes.
` Q. I hope you understand I'm trying -- it's
`okay if I try to keep the record straight?
` A. Understood.
` Q. Is it your opinion that prior to Latuda®'s
`approval, there were several atypical antipsychotics
`available for sale on the market for the treatment
`of various mental illnesses?
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