PUBLIC VERSION
`UNITED STATES PATENT AND TRADEMARK OFFICE
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`---------------------------x
`ACRUX DDS PTY LTD. & ACRUX :
`LIMITED,
`: CASE: IPR2017-00190
`Petitioners,
`: U.S. PATENT 7,214,506
`v.
`:
`KAKEN PHARMACEUTICAL CO., :
`LTD. and VALEANT
`:
`PHARMACEUTICALS
`:
`INTERNATIONAL, INC.,
`:
`Patent Owner and Licensee:
`---------------------------x
`CONFIDENTIAL PURSUANT TO PROTECTIVE ORDER
`
`Deposition of Yoshiyuki Tatsumi, Ph.D.
`Atlanta, Georgia
`Wednesday, October 11, 2017
`9:28 a.m.
`
`Job No.: 136442
`Pages 1 - 98
`Reported by: Robyn Bosworth, RPR, CRR
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`ACRUX DDS PTY LTD. et al.
`
`EXHIBIT 1506
`
`IPR Petition for
`
`U.S. Patent No. 7,214,506
`
`Page 1 of 126
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`---------------------------x
`ACRUX DDS PTY LTD. & ACRUX :
`LIMITED,
`: CASE: IPR2017-00190
`Petitioners,
`: U.S. PATENT 7,214,506
`v.
`:
`KAKEN PHARMACEUTICAL CO., :
`LTD. and VALEANT
`:
`PHARMACEUTICALS
`:
`INTERNATIONAL, INC.,
`:
`Patent Owner and Licensee:
`---------------------------x
`CONFIDENTIAL PURSUANT TO PROTECTIVE ORDER
`
`Deposition of Yoshiyuki Tatsumi, Ph.D.
`Atlanta, Georgia
`Wednesday, October 11, 2017
`9:28 a.m.
`
`Job No.: 136442
`Pages 1 - 98
`Reported by: Robyn Bosworth, RPR, CRR
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`IPR Petition for
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`U.S. Patent No. 7,214,506
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`Page 1 of 126
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`CONFIDENTIAL PURSUANT TO PROTECTIVE ORDER
`Transcript of Yoshiyuki Tatsumi, Ph.D.
`Conducted on October 11, 2017
`
`2
`
` Deposition of YOSHIYUKI TATSUMI, Ph.D., held
`at:
`
`Finnegan, Henderson, Farabow, Garrett & Dunner,
`LLP
`271 17th Street, N.W.
`Suite 1400
`Atlanta, Georgia 30363
`404.653.6400
`
` Pursuant to Notice, before ROBYN BOSWORTH,
`RPR, CRR, CCR-B-2138.
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`Transcript of Yoshiyuki Tatsumi, Ph.D.
`Conducted on October 11, 2017
`
`3
`
` A P P E A R A N C E S
`ON BEHALF OF THE PETITIONERS:
` AYDIN H. HARSTON, Ph.D., ESQUIRE
` ROTHWELL, FIGG, ERNST & MANBECK, P.C.
` 607 14th Street, N.W., Suite 800
` Washington, DC 20005
` (202) 783-6040
`
`ON BEHALF OF THE PATENT OWNER AND LICENSEE:
` JOHN D. LIVINGSTONE, ESQUIRE
` ASHLEY WINKLER, ESQUIRE
` FINNEGAN, HENDERSON, FARABOW, GARRETT &
` DUNNER, LLP
` 271 17th Street, N.W., Suite 1400
` Atlanta, Georgia 30363
` (404) 653-6400
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`Conducted on October 11, 2017
`
`4
`
` A P P E A R A N C E S C O N T I N U E D
`
`A L S O P R E S E N T:
` INTERPRETER: YOKO DE GROOT
` CHECK INTERPRETER: JUNKO Y. SALMON
` SHANNON LENTZ, ESQUIRE, CROWELL & MORING
` YASUHITO IIDA, KAKEN PHARMACEUTICALS
` TOMOHIRO TAKAYA, Ph.D., KAKEN
` PHARMACEUTICALS
` KOUJI MATSUMOTO, KAKEN PHARMACEUTICALS
` TAKESHI ASANO, KAKEN PHARMACEUTICALS
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`Conducted on October 11, 2017
`
`5
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` C O N T E N T S
`EXAMINATION OF YOSHIYUKI TATSUMI, Ph.D. PAGE
` By Mr. Harston 8
` By Mr. Livingstone 83
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`Transcript of Yoshiyuki Tatsumi, Ph.D.
`Conducted on October 11, 2017
`
`6
`
` E X H I B I T S
` (Attached to Transcript)
`DEPOSITION EXHIBIT PAGE
`1 U.S. Patent No. 5,962,476 66
`1001 U.S. Patent No. 7,214,506 27
`1002 Translation of JPOO/04617 Priority
` Document for the '506 patent 70
`2001 Japanese version of Exhibit 2003 39
`2002 Japanese version of Exhibit 2004 46
`2003 Declaration of Dr. Tatsumi, Filed:
` February 2, 2017 39
`2004 Research and Development Activity
` Report dated May 28, 1999 46
`2024 Japanese version of Exhibit 2025 62
`2025 Declaration of Dr. Tatsumi, Filed:
` August 1, 2017 62
`2042 Japanese version of Exhibit 2043 81
`2043 Excel sheet containing experiment
` results mentioned in Exhibit 2045 81
`2045 Untranslated document authored by
` Dr. Tatsumi 79
`2107 Abstract F790 90
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`Conducted on October 11, 2017
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`7
`
` E X H I B I T S
` (Attached to Transcript)
`DEPOSITION EXHIBIT PAGE
`2108 Abstract F792 90
`2109 Abstract F793 90
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`Conducted on October 11, 2017
`
`8
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` P R O C E E D I N G S
` (Yoko Azuma de Groot was sworn as the
`Japanese Interpreter by the reporter.)
` YOSHIYUKI TATSUMI, Ph.D.,
`having been first duly sworn, testified through
`the Japanese Interpreter as follows:
` EXAMINATION
`BY MR. HARSTON:
` Q Good morning, Dr. Tatsumi. My name is
`Aydin Harston, and I represent Acrux in this matter.
`With me here is Shannon Lentz, from the law firm of
`Crowell & Moring.
` Could you please state your full name for
`the record, please.
` A Good morning. Thank you so much. My name
`is Tatsumi Yoshiyuki.
` Q Have you ever had your deposition taken
`before?
` A No.
` Q All right. So I'm just going to give some
`ground rules. My job here is to ask you a series of
`questions, and your job is to answer those questions
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`
`9
`
`with verbal answers.
` A Yes.
` Q Thank you.
` So I understand we're using a translator
`today. The court reporter needs to take down my
`questions, so we should not speak over each other.
`I think it probably will not be an issue today with
`the translator use.
` A Yes.
` Q Thank you.
` And if at any time I ask you a question
`and you don't understand, please -- you can ask me
`to rephrase it. Do you understand that?
` A Yes, I understand.
` Q And if you don't ask me to rephrase the
`question that I ask, I'm going to assume that you
`understand the question. Okay?
` A Yes.
` Q And from time to time during the
`deposition today, your counsel may make objections
`for the record. Unless you get an instruction not
`to answer, you are to answer the question. Do you
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`10
`
`understand that?
` A Yes, I do.
` Q And if you need to take a break today,
`just ask. The only condition is that I ask that you
`don't request a break during the middle of a
`question. You understand?
` A Yes, I understand.
` Q And you understand that you're under oath
`today?
` A Yes.
` Q Is there any reason that you can't give
`complete and truthful testimony here today?
` A No.
` Q You're not under any medications that
`might prevent you from giving clear and complete
`testimony today?
` A I have not taken any medications.
` Q Can you please state your address for the
`record?
` A My current address is 6-20-8, Ogoto,
`Otsu-Shi, Shiga-Prefecture, Japan.
` Q Are you able to read English?
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`Conducted on October 11, 2017
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`11
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` A Well, yes, to some extent. To some extent
`I can. Especially technical terms, yes.
` Q And are you able to understand English?
` A Well, I can understand easy daily
`conversation, to that extent; but if it's very --
`spoken in fast speed, difficult for me to
`understand.
` Q Thank you. I will try to speak slowly.
` Who is your employer?
` A My employer is Kaken Pharmaceutical --
`Kaken Pharmaceuticals.
` Q What is your title there at Kaken
`Pharmaceuticals?
` A My title is group manager.
` Q And what group is it that you are the
`group manager of?
` A I am a group manager of -- today, we call
`pharmacological -- pharmacology department, but
`three years ago that department was called
`pharmacological research department of research
`center Kaken.
` Q Approximately how many employees does
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`Conducted on October 11, 2017
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`12
`
`Kaken have?
` A I don't remember precisely, but I believe
`the number of employees is about 1400 to 1500.
` Q Is Kaken a publicly traded company in
`Japan?
` A Yes, it is.
` Q And about how long has Kaken been in
`business?
` A Are you asking me about Kaken
`Pharmaceutical Company -- pharmaceutical business,
`are you asking me about that?
` Q If there are other businesses, you can
`also tell me about those. I'm just asking generally
`how long has Kaken?
` A To your first question, the company was
`established 1948. Therefore, counting from that
`point, for about 70 years that Kaken Pharmaceuticals
`had been -- had been engaged in
`pharmaceutical-related business.
` And the other business that Kaken is
`involved is sales of agricultural chemicals, but for
`that I don't know when it started. I cannot tell
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`Conducted on October 11, 2017
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`13
`
`you exactly.
` Q Okay. What is your educational
`background?
` A In 1990, I graduated from pharmaceutical
`sciences of Kindai University, K-I-N-D-A-I
`University.
` Also, in 1992, I graduated from master --
`Master's degree in pharmaceuticals from the same
`department -- same university of said department.
` Q And you are not a medical doctor, correct?
` A I am a doctor of pharmaceuticals --
`pharmaceutics. I'm a doctor of pharmaceutics.
` Q Does that mean you have a Ph.D, a
`doctorate degree?
` A This might be a unique system in Japan,
`but -- only practice in Japan maybe, but there is a
`system that if a student writes several theses --
`dissertations, and also make application to the
`university for Ph.D., and that is allowed. Through
`that system, I gained Ph.D.
` Q Thank you.
` So you do not treat patients, correct?
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`Conducted on October 11, 2017
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`14
`
` A Not at all.
` Q And you have never treated patients,
`correct?
` A No.
` Q Who did you meet with or speak
`telephonically with to prepare for your deposition?
` A I spoke with the attorney or attorneys, I
`don't know -- I spoke with attorney.
` Q Can you name the attorneys, please?
` A They are John -- right next -- John and
`Ashley.
` Q So John Livingstone and Ashley Winkler,
`correct?
` A Yes.
` Q Thank you.
` And when did you meet with them?
` A I met them two days ago.
` Q You met two days ago, but not -- what
`about yesterday, did you meet with them yesterday?
` A I met them yesterday as well.
` Q For about how long did you meet?
` A I met them since starting from the
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`Conducted on October 11, 2017
`
`15
`
`morning.
` Q So for the full day on each two -- on each
`of the two days, correct?
` A I would say full day -- rather than from
`full day, I would say from morning till the evening.
` Q Thank you.
` Did you review any documents while you
`were meeting?
` MR. LIVINGSTONE: I'll instruct you to
`answer that question yes or no.
` A Could you repeat the question again?
`BY MR. HARSTON:
` Q Sure. Did you review any documents while
`you were meeting with your counsel?
` A When you say review -- when you say
`review, are you saying review with two -- two of us,
`is that what you're saying?
` Q Right. Yes, while you were meeting with
`your counsel, did you together review any documents?
` A Yes.
` Q And the events that you address in your
`declarations occurred about 20 to 25 years ago,
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`Conducted on October 11, 2017
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`16
`
`correct?
` MR. LIVINGSTONE: I'll object to the
`extent it misstates the declaration, Mr. Tatsumi's
`declaration.
` You can answer the question if you
`understand it.
` A Yes, there are contents I declared, but --
`things what happened -- things that happened 20
`years ago, but the third declaration regarding the
`status of -- the recent status of reference
`materials -- document -- okay. The third
`declaration refers to document storage of current
`situation, that is describing more about the most
`recent.
`BY MR. HARSTON:
` Q And did any of the documents that you
`reviewed refresh your recollection of those events?
` MR. LIVINGSTONE: And I will object to the
`extent that it uses a legal term that might be
`confusing.
` And I will stipulate for the record that
`we did not review any documents that have not been
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`Conducted on October 11, 2017
`
`17
`
`produced in this proceeding or are not available
`through the public record. We didn't look at
`anything that was confidential and you haven't seen
`before.
` A I have already -- I've submitted all the
`documents that can be publicly seen, so I have not
`seen anything else other than those things.
`BY MR. HARSTON:
` Q When you say all of the documents that can
`be publicly seen, are there documents that cannot be
`publicly seen that you have in your possession?
` MR. LIVINGSTONE: I will instruct you, if
`you answer that question, make sure you don't
`disclose any privileged communications you had with
`either your attorneys at Finnegan or your attorneys
`at Kaken.
` A Yes.
`BY MR. HARSTON:
` Q What kinds of documents are those?
` MR. LIVINGSTONE: I'll give the same
`instruction.
` A I will not be able to answer to your
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`18
`
`question as it will -- it will get into the
`privileged -- privileged confidentiality with my
`attorneys.
` It's privileged information, therefore I
`will not be able to answer.
`BY MR. HARSTON:
` Q I'm not asking for the communications with
`your attorneys, I'm asking what kinds of documents
`are they?
` MR. LIVINGSTONE: And if I may, I don't
`mean to step on your toes, but I think what
`Mr. Harston is asking for is, apart from the
`privileged documents that -- not documents, but the
`privileged things you may have discussed with your
`attorneys, are there documents that you looked at
`that have not been produced in this litigation.
` Is that fair?
` MR. HARSTON: I think the answer to that
`is already yes. It's what kinds of documents are
`they?
` MR. LIVINGSTONE: That he reviewed?
` MR. HARSTON: That he was just speaking
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`19
`
`about, that he just answered that yes, there are
`documents that are not -- cannot be publicly seen.
` MR. LIVINGSTONE: Those are privileged.
`He just said that.
` MR. HARSTON: What kinds of documents are
`they?
` MR. LIVINGSTONE: That's privileged.
` MR. HARSTON: It's not a privileged
`communication, it's just a description.
`BY MR. HARSTON:
` Q Is it a memo, is it a lab notebook, is it
`a contract, what is it?
` MR. LIVINGSTONE: You can answer that
`question.
` THE INTERPRETER: Do you want me to
`interpret everything?
` MR. LIVINGSTONE: Please.
` MR. HARSTON: Please.
` A The documents I saw were my declaration
`and also several -- several dissertations that were
`presented from the other party.
`BY MR. HARSTON:
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`20
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` Q When you say the other party, who is the
`other party?
` A Those dissertations I mean are the
`documents that were presented from Acrux side.
` MR. LIVINGSTONE: I think he meant
`declaration. Not dissertation, declaration.
` I'm going to instruct you not to answer
`any more of those questions about the types of
`documents because you're getting into the work
`product.
` I told you those publicly available
`documents were reviewed with him, and he doesn't
`understand your question about the privilege. If
`you'd like me to, I can go outside and talk to him
`about that and explain it to him, so he can give you
`the right answer; but until he understands exactly
`what you're asking, I'm not going to allow him to
`answer any more of those questions.
`BY MR. HARSTON:
` Q I don't think we even need a translation
`of this part. I think we went off track. We were
`talking about -- we were talking about documents
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`Conducted on October 11, 2017
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`21
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`that cannot be publicly seen. Everything that Acrux
`has produced is public, is on the public record.
` So the question is, what are the -- what
`types of documents cannot be publicly seen in this
`case that you've reviewed?
` MR. LIVINGSTONE: And I'm really not
`trying to be difficult, but I'm not going to let him
`answer because I really don't think he understands
`the question. And if you'll let me talk to him for
`a second and find out what he's thinking of, and
`make sure he doesn't disclose work product
`information in his answer, I'm happy to let him
`answer the question. But if I think he's going to
`give work product information, I'm not going to let
`him answer.
`BY MR. HARSTON:
` Q I'm going to ask this a different way.
`You said that there are documents that cannot be
`publicly seen, correct?
` A No, I don't mean I said that. Well,
`when -- about the declaration, then -- are you
`talking about the -- are you referring to the
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`Conducted on October 11, 2017
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`22
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`company --
` CHECK INTERPRETER: When you talk about
`documents, are you talking about research papers
`that have been published, or are you talking about
`internal documents?
`BY MR. HARSTON:
` Q I'm asking about any documents that you've
`seen that you refer to as documents that cannot be
`publicly seen?
` MR. LIVINGSTONE: With the caveat of it
`being during your preparation for your deposition.
` A When I use the word "publicly seen," that
`I meant -- I referred to those documents that were
`described within the depositions -- that were
`disclosed within the depositions, but I did not mean
`any other documents other than those that were --
`other than those that were described in depositions.
` MR. LIVINGSTONE: Deposition preparation.
` A Excuse me, I meant declaration, not
`deposition. So those lab notes or other of those
`documents were mentioned in the declaration.
`BY MR. HARSTON:
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`23
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` Q So you did not -- did you review any
`documents in preparation for this deposition that
`were not mentioned in your declaration?
` A I will not be able to answer to your
`question as my answer would go into the area of
`privileged -- of disclosing privileged information
`with my attorney.
` Q This is just a yes or no question. Yes,
`you did review, or no, you did not review.
` MR. LIVINGSTONE: You can answer yes or
`no.
` A I want to make sure your question is that
`if I have reviewed documents other than those
`described in the declaration.
` CHECK INTERPRETER: Documents other than
`declarations.
`BY MR. HARSTON:
` Q I'm asking about any documents that were
`not mentioned in the declaration or the declarations
`themselves.
` A I had a look at it or them, to that level,
`when you said -- when I said review -- when I said
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`reviewed, I meant -- I mean, I had looked at it to
`that extent.
` Q So the answer is yes?
` A Yes.
` Q Thank you.
` A I would like to know, when you use the
`word "review," to what degree or extent that you
`are -- that you are -- you are referring to?
` Q Sure. I mean did you read it?
` A I did not read.
` Q What did you mean when you said you
`reviewed?
` A I did not read, but just glanced through,
`oh, yeah, recognize, oh, this type of documents.
`Just skimming through very quickly.
` Q When you glanced, what type of documents
`were they?
` MR. LIVINGSTONE: I'll instruct you not to
`answer the specific documents, but just the general
`types of documents.
` A Again, I did not read them, but I quickly
`skimmed through research papers.
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`BY MR. HARSTON:
` Q Were these research papers ever published?
` A They are. They include my research
`papers, therefore, they were published.
` Q Since they were published, they cannot be
`privileged or confidential. So can you identify
`what these publications were?
` MR. LIVINGSTONE: I instruct you not to
`answer that question. That gets into the work
`product for our deposition preparation.
` MR. HARSTON: So your work product --
` MR. LIVINGSTONE: Includes the documents I
`showed him, which I told you are publicly available.
` MR. HARSTON: Are those of record in this
`case?
` MR. LIVINGSTONE: They're either of record
`in the case or publicly available.
` MR. HARSTON: If they're of record in this
`case, can you identify which ones they are?
` MR. LIVINGSTONE: No, I can't. That's
`work product, Aydin.
`BY MR. HARSTON:
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` Q We'll move on. So you reviewed your
`declarations in preparation for today's deposition,
`correct?
` A Actually, whether this declaration is --
`is a right one or not, with that purpose I reviewed
`it. And, consequently, I confirmed there was no
`issue about this.
` CHECK INTERPRETER: Went through the
`declarations to check the accuracy and ensure that
`they're still accurate.
`BY MR. HARSTON:
` Q Okay.
` THE INTERPRETER: That's fine.
`BY MR. HARSTON:
` Q So you did not notice anything that needed
`to be corrected or changed, correct?
` A But the necessity of changes, well, I
`checked what I made the declaration, it is correct.
` And then I made declarations three times.
`And from declaration 1 to declaration 2, the meaning
`was the same, but just expression was -- was
`changed.
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` So overall, I rechecked that -- that the
`constancy of what I declared remains the same in my
`declaration. That's what I did.
` Q Are you being compensated for your time
`here today?
` A So compensation by company? Well, this
`was -- is regarded as an -- this is regarded as
`business trip overseas at an hourly -- sorry, at a
`daily per diem. Daily per diem. At per diem.
` Q And do you know what the amount of that
`per diem is?
` A Although I don't recall that clearly, but
`I would say it would be several thousand yen. I'm
`talking per day, the compensation is several
`thousand yen.
` Q And are you being compensated by anyone
`other than by Kaken?
` A No.
` (Exhibit 1001 was marked for
`identification and is attached to the transcript.)
`BY MR. HARSTON:
` Q I've placed before you a document that's
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`been identified as Exhibit 1001. Do you recognize
`this to be U.S. Patent Number 7,214,506?
` A I can recognize it.
` Q And you understand that this deposition
`relates to a Patent Office proceeding related to
`this patent, correct?
` A Yes, I do.
` Q When were you first approached about
`signing a declaration for this proceeding?
` A Are you asking the date when I signed my
`declaration?
` Q No, I'm asking when were you first
`approached about -- the first time that you were
`approached about signing a declaration for this
`case?
` A So just again I would like to make sure
`what you're asking is that when I was asked -- for
`the first time when I was asked to write a
`declaration, is that the date you are asking?
` Q That's right.
` A I won't be able to answer to your question
`since it is involving a privileged matter with my
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`attorney.
` MR. LIVINGSTONE: All Mr. Harston is
`asking for is if you recall the date or around when
`you were first approached for the declaration, and
`you can answer the date.
` A Although I don't recall exactly, but I
`believe it would be around February this year.
`BY MR. HARSTON:
` Q And who approached you?
` MR. LIVINGSTONE: You can answer that
`question as well. Just don't disclose any
`communications you had with any attorneys.
` A I was approached by the IP -- intellectual
`property department of my company, then I started to
`think about it.
`BY MR. HARSTON:
` Q And did you receive any payment for your
`time spent preparing the declarations?
` A Are you asking payment by the company --
`by my company?
` Q Payment by anybody.
` A There was no specific payment for that --
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`for that because I did the work during my business
`hours.
` Q When you first received the draft of the
`declaration, did it have exhibits or attachments
`with it?
` MR. LIVINGSTONE: Objection, assumes facts
`not in evidence.
` THE INTERPRETER: The witness wants to
`make sure that he will be able to answer.
` MR. LIVINGSTONE: You can answer that
`question yes or no.
` A So you are asking me if there's any
`attachments to it?
`BY MR. HARSTON:
` Q Yes.
` A To the declaration?
` Q Yes.
` A There was none but declaration itself --
`draft of the declaration itself.
` Q Did you make any changes to the draft of
`the declaration?
` MR. LIVINGSTONE: You can answer yes or
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`no.
` A Yes.
`BY MR. HARSTON:
` Q Who reviewed those changes?
` MR. LIVINGSTONE: Objection, foundation.
` THE WITNESS: So you asked objection
`regarding foundation of the question, so what am I
`supposed to answer?
` MR. LIVINGSTONE: You can answer the
`question, but, again, don't disclose any
`communications or the substance of any
`communications with any of your attorneys.
` A I forgot the question that you posed, so
`just what was your question I should answer to?
`BY MR. HARSTON:
` Q Who reviewed the changes to the draft
`declaration that you made?
` A The changes I added were insignificant,
`such as name of the university or the name of
`department back then. So I gave those changes to
`the IP department. I believe somebody at the IP
`department must have reviewed that.
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` Q Who added the attachments to the
`declaration?
` MR. LIVINGSTONE: I'm going to object to
`that as requesting or calling for privileged
`information, and I'm going to instruct you not to
`answer.
` A I will not be able to answer to your
`question as it will involve privileged information
`with my attorneys.
`BY MR. HARSTON:
` Q Well, I'm just asking about a person, but
`let's ask it this way, did someone other than you
`add the attachments to the declaration? This is a
`yes or no question.
` MR. LIVINGSTONE: I'll object and ask,
`which declaration? There's three of them.
`BY MR. HARSTON:
` Q Any of them. Well, let's start with the
`first one. Sorry, the first one.
` MR. LIVINGSTONE: I'll object as vague as
`to the term "add."
` A I will not be able to answer the question
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`because it will be involving privileged information
`with my attorneys.
`BY MR. HARSTON:
` Q This is not a privileged communication.
`It's a yes or no question.
` MR. LIVINGSTONE: How his declaration was
`put together is work product and privileged
`information, and I'm going to instruct him not to
`answer any of those questions.
` MR. HARSTON: The entire declaration has
`to do with providing
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