Confidential - Subject to The Protective Order
`Shirou Sawa - March 1, 2016
`
` U N I T E D S T A T E S P A T E N T A N D T R A D E M A R K O F F I C E
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` B E F O R E T H E P A T E N T T R I A L A N D A P P E A L B O A R D
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`I N N O P H A R M A L I C E N S I N G , I N C . , )
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`I N N O P H A R M A L I C E N S I N G L L C , )
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`I N N O P H A R M A I N C . , I N N O P H A R M A L L C )
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`M Y L A N P H A R M A C E U T I C A L S I N C . a n d )
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`M Y L A N I N C . , )
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` P e t i t i o n e r s , ) C a s e N o s .
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` v s . ) I P R 2 0 1 5 - 0 0 9 0 2
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`S E N J U P H A R M A C E U T I C A L C O . , L T D . , ) I P R 2 0 1 5 - 0 0 9 0 3
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`B A U S C H & L O M B , I N C . , a n d B A U S C H )
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`& L O M B P H A R M A H O L D I N G S C O R P . , )
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` P a t e n t O w n e r . )
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` C O N F I D E N T I A L S U B J E C T T O T H E P R O T E C T I V E O R D E R
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` V I D E O T A P E D D E P O S I T I O N O F
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` S H I R O U S A W A
`
` W a s h i n g t o n , D C 2 0 0 0 1
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` T u e s d a y , M a r c h 1 , 2 0 1 6
`
`GregoryEdwards, LLC | Worldwide Court Reporting
`GregoryEdwards.com | 866-4Team GE
`
`

`
`Confidential - Subject to The Protective Order
`Shirou Sawa - March 1, 2016
`
`2 (Pages 2 to 5)
`
`Page 4
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` A P P E A R A N C E S (continued)
`
`For the Lupin Petitioner:
`CROWELL & MORING
` 1001 Pennsylvania Avenue NW
` Washington, DC 20004-2595
` 202.624.2947
`BY: DEBORAH H. YELLIN, ESQ.
` dyellin@crowell.com
`GOODWIN PROCTER LLP
` The New York Times Building
` 620 Eighth Avenue
` New York, NY 10018
` 212.813.8800
`BY: ELIZABETH J. HOLLAND, ESQ.
` eholland@goodwinprocter.com
`
`Also Present:
` Naoko Kishida, Senju Pharmaceuticals
` Rika T. Mitrik, Interpreter
` Yuko Kashiwagi, Check Interpreter
` T.J. O'Toole, Videographer
`
` I N D E X
`
`Page 5
`
`CROSS-EXAMINATION OF SHIROU SAWA PAGE
`By Mr. Abe 12
` -o0o-
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` Tuesday, March 1, 2016
` 9:28 a.m.
`
`Page 2
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`VIDEOTAPED DEPOSITION OF SHIROU SAWA, held at the
`offices of:
`
` FINNEGAN HENDERSON FARABOW
` GARRETT & DUNNER, LLP
` 901 New York Avenue NW
` Washington, DC 20001
`
`Pursuant to notice, before Denise D. Vickery,
`Registered Merit Reporter, Certified Realtime
`Reporter, and Notary Public in and for the District
`of Columbia.
`
`Page 3
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` A P P E A R A N C E S
`
`For the InnoPharma Petitioner:
`ALSTON & BIRD LLP
` 333 South Hope Street, Sixteenth Floor
` Los Angeles, CA 90071
` 213.576.1000
`BY: HIDETADA JAMES ABE, ESQ.
` james.abe@alston.com
`
`For the Patent Owner:
`FINNEGAN HENDERSON FARABOW GARRETT & DUNNER, LLP
` 901 New York Avenue NW
` Washington, DC 20001
` 202.408.4000
`BY: BRYAN C. DINER, ESQ.
` bryan.diner@finnegan.com
`BY: JUSTIN J. HASFORD, ESQ.
` justin.hasford@finnegan.com
`BY: CHIAKI FUJIWARA, ESQ.
` Chiaka.fujiwara@finnegan.com
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`GregoryEdwards, LLC | Worldwide Court Reporting
`GregoryEdwards.com | 866-4Team GE
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`

`
`Confidential - Subject to The Protective Order
`Shirou Sawa - March 1, 2016
`
`3 (Pages 6 to 9)
`
`Page 8
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`Bird, for InnoPharma Petitioner.
` MS. YELLIN: Deborah Yellin for
`Petitioner Lupin.
` MS. HOLLAND: Elizabeth Holland of
`Goodwin Procter for Lupin.
` MR. DINER: Bryan Diner, Finnegan
`law firm, for the Patent Owner Senju, et al. With
`me is -- are my colleagues Chiaki Fujiwara, Justin
`Hasford, our check interpreter Yuko Kashiwagi, and
`Naoko Kishida from Senju.
` THE VIDEOGRAPHER: Thank you.
` Will the lead interpreter identify
`herself for the record.
` THE INTERPRETER: Rika Mitrik.
` THE VIDEOGRAPHER: Thank you.
` Will the court reporter please
`swear in the lead interpreter.
` - - -
` RIKA MITRIK
`was duly sworn to interpret English into Japanese
`and Japanese into English language.
` THE VIDEOGRAPHER: Will the lead
`
`Page 9
`
`interpreter please assist the court reporter in
`swearing in the witness.
` - - -
` SHIROU SAWA
`called for examination, and, after having been duly
`sworn, was examined and testified as follows:
` CHECK INTERPRETER: The check
`interpreter for Senju asks: Do you wish to have her
`sworn in?
` MR. DINER: Please swear her in.
` - - -
` YUKO KASHIWAGI
`was duly sworn to interpret English into Japanese
`and Japanese into English language.
` (The following proceedings took
`place through the official interpreter.)
` MR. DINER: James, before we get
`started, we noticed that the declaration for
`Mr. Sawa in the 903 --
` MR. ABE: Yes.
` MR. DINER: -- IPR had some
`mistakes and printing errors in the PDFs.
`
` E X H I B I T S
`
`Page 6
`
` PRIOR MARKED EXHIBITS
`EXHIBIT DESCRIPTION PAGE
`Senju Exhibit 2098 IPR2015-00902 18
` Declaration of Shirou Sawa
` Page 1 through Page 663
` English Translation
`Innopharma EX1001 23
` Page 1 through Page 9
` US Patent No. 8,669,290
` Sawa et al.
` -o0o-
`
`Page 7
`
` P R O C E E D I N G S
` - - -
` THE VIDEOGRAPHER: On the record
`with disk 1 of the deposition of -- video deposition
`of Mr. Shirou Sawa taken by the Petitioner in the
`matter of InnoPharma Licensing Incorporated, et al.
`versus Senju Pharmaceuticals Company, Limited, et
`al, being heard before the Patent Trial and Appeal
`Board of the United States Patent and Trademark
`Office, Case No. IPR 2015-00902.
` This deposition is being held at
`the Finnegan law offices located at 901 New York
`Avenue Northwest in Washington, DC on March 1, 2016
`at approximately 9:28 a.m.
` My name is T.J. O'Toole. I am the
`certified legal video specialist. The court
`reporter is Denise Vickery. We are both here
`representing Gregory Edwards, LLC.
` Will counsel please identify
`themselves and indicate which parties they
`represent.
` MR. ABE: James Abe, Alston &
`
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`GregoryEdwards, LLC | Worldwide Court Reporting
`GregoryEdwards.com | 866-4Team GE
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`Page 3
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`

`
`Confidential - Subject to The Protective Order
`Shirou Sawa - March 1, 2016
`
`Page 10
`
` MR. ABE: Right. Right.
` MR. DINER: And so we have -- but
`as you know, the declaration is exactly the same and
`it's used for both proceedings 902 and 903.
` So as a courtesy, we have brought
`today for you a complete copy with the printing
`errors corrected in the 903 IPR. So I'd like to
`give that to you.
` MR. ABE: Okay.
` MR. HASFORD: And before we begin,
`Senju has an objection. Senju objects to
`Ms. Holland being here.
` Ms. Holland, you're not counsel of
`record in these IPR proceedings, and it's our
`understanding that you're not signed on under the
`PTAB protective order. Will you agree to leave? If
`not, we will have to call the Board.
` MR. ABE: I believe I have
`forwarded Ms. Holland's protective order -- signed
`protective order to counsel for Finnegan.
` MR. HASFORD: I don't believe we
`ever received that, and she's not counsel of record
`
`Page 11
`
`in any event.
` MS. HOLLAND: Well, if I'm signed
`on under the protective order, then I can be here.
` MR. HASFORD: Okay. Well, I don't
`believe we received that.
` MR. DINER: We'll need to
`establish that. James, can you send that?
` MR. ABE: Yes, let me try to find
`it. It's been a while.
` MS. YELLIN: It went to you on
`February 8, 2016 at 9:21 p.m. from James.
` Do you want me to forward it to
`you, James?
` MR. ABE: I think I found it.
`Yes, February 8th. Yes, Elizabeth Holland signed
`February 8th for the protective order in this case.
`I'm happy to reforward it.
` MR. HASFORD: Okay. I'm sorry.
`Say it again.
` MR. ABE: Yes. Ms. Holland's
`signed protective order is there.
` MR. HASFORD: Can you please
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`4 (Pages 10 to 13)
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`Page 12
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`forward it to me real quick?
` MR. ABE: Sure.
` MR. HASFORD: Yeah.
` MR. ABE: Just to you?
` MR. HASFORD: Just -- yeah.
` Okay. Thank you.
` CROSS-EXAMINATION
`BY MR. ABE:
`
` Q. Q. Okay. Good morning, Mr. Sawa.
`
` Q. Q.
`
` A. A. Good morning.
`
` A. A.
`
` Q. Q. Can you state your name for the record?
`
` Q. Q.
`
` A. A. My name is Shirou Sawa.
`
` A. A.
`
` Q. Q. I understand you've been deposed
`
` Q. Q.
`previously in relation to a District Court case; is
`that right?
`
` A. A. I couldn't catch the first part.
`
` A. A.
` MR. ABE: If you could repeat
`that.
` THE WITNESS: That's correct.
`BY MR. ABE:
`
` Q. Q. Have you been deposed aside for that,
`
` Q. Q.
`from that deposition?
`
`Page 13
`
`
` A. A. No.
`
` A. A.
`
` Q. Q. Have you ever testified in an IPR
`
` Q. Q.
`proceeding?
` And IPR stands for inter partes review
`patent proceeding at the United States Patent
`Office.
`
` A. A. No, I have not.
`
` A. A.
`
` Q. Q. Okay. I'll go over the basic rules for
`
` Q. Q.
`you.
`
` A. A. Okay.
`
` A. A.
`
` Q. Q. I represent the InnoPharma entities.
`
` Q. Q.
`And I will be asking questions today. And I'll ask
`you to answer my questions. Your counsel might
`object. But unless your counsel instructs you not
`to answer, I'll expect you to answer.
`
` A. A. Okay.
`
` A. A.
`
` Q. Q. And please give audible answers.
`
` Q. Q.
`
` A. A. Okay.
`
` A. A.
`
` Q. Q. And if you don't understand a question
`
` Q. Q.
`I'm asking, just let me know.
`
` A. A. Okay.
`
` A. A.
`
` Q. Q. If you don't -- let me start over.
`
` Q. Q.
`
`GregoryEdwards, LLC | Worldwide Court Reporting
`GregoryEdwards.com | 866-4Team GE
`
`Page 4
`
`

`
`Confidential - Subject to The Protective Order
`Shirou Sawa - March 1, 2016
`
`Page 14
`
` If you answer my question, I'll assume
`you understand -- understood my question.
`
` A. A. Okay.
`
` A. A.
`
` Q. Q. Is there any reason you can't testify
`
` Q. Q.
`truthfully today?
`
` A. A. No, there isn't.
`
` A. A.
` MR. ABE: Will counsel stipulate
`that Mr. Sawa is here for his cross-examination for
`both the IPR 2015-00902 and 903?
` MR. DINER: Yes.
` MR. ABE: And will counsel also
`stipulate that my questions will apply for both IPR
`proceedings?
` MR. HASFORD: Unless he specifies
`otherwise.
` MR. ABE: Unless I specify
`otherwise.
` MR. DINER: That's fine.
`BY MR. ABE:
`
` Q. Q. Okay. Mr. Sawa, how did you --
`
` Q. Q.
` MR. DINER: One -- I'm sorry,
`James.
`
`Page 15
`
` MR. ABE: Yes.
` MR. DINER: Just one thing. I
`think we have agreed that because they are the
`combined deposition, it's going to be seven -- max
`of seven-hour deposition time.
` MR. ABE: Yes, that's fine.
` MR. DINER: Okay.
`BY MR. ABE:
`
` Q. Q. Mr. Sawa, how did you prepare for
`
` Q. Q.
`today's examination?
` MR. DINER: Instruct the witness
`just to not divulge any communications that you had
`with anyone that you met with in preparation of your
`deposition.
` THE WITNESS: I consulted with
`attorneys from Finnegan.
`BY MR. ABE:
`
` Q. Q. Which attorneys?
`
` Q. Q.
`
` A. A. Bryan and Chiaki and Justin.
`
` A. A.
`
` Q. Q. When did you meet with them?
`
` Q. Q.
`
` A. A. (Pause). It was around December of
`
` A. A.
`last year.
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`5 (Pages 14 to 17)
`
`Page 16
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` Q. Q. December when you had your District
`
` Q. Q.
`Court deposition?
`
` A. A. Yes.
`
` A. A.
`
` Q. Q. Did you meet with the attorneys from
`
` Q. Q.
`Finnegan after your District Court deposition and
`before today?
` THE INTERPRETER: Witness asked to
`repeat that.
`BY MR. ABE:
`
` Q. Q. Let me withdraw the question, ask it a
`
` Q. Q.
`little differently.
` Did you meet with your attorneys from
`Finnegan, aside from today, in the past week?
`
` A. A. Yes.
`
` A. A.
`
` Q. Q. When was that?
`
` Q. Q.
`
` A. A. Yesterday and the day before.
`
` A. A.
`
` Q. Q. And those were for preparation for this
`
` Q. Q.
`deposition?
`
` A. A. Yes.
`
` A. A.
`
` Q. Q. How many hours for each day did you
`
` Q. Q.
`meet with the attorneys?
`
` A. A. About eight hours.
`
` A. A.
`
`Page 17
`
`
` Q. Q. For each day?
`
` Q. Q.
`
` A. A. Yes.
`
` A. A.
`
` Q. Q. Did you meet with anybody other than
`
` Q. Q.
`your Finnegan attorneys?
` MR. DINER: Objection. Vague.
` THE WITNESS: No.
`BY MR. ABE:
`
` Q. Q. Did you review any documents in
`
` Q. Q.
`preparation for today's cross-examination?
` MR. DINER: You may answer that
`question yes or no, but do not disclose or divulge
`any documents you may have reviewed.
` CHECK INTERPRETER: Check
`interpreter for Senju would note that it wasn't the
`contents of the documents that Mr. Diner mentioned
`in his objection. It was divulge any documents you
`may have reviewed.
` THE INTERPRETER: (Translating).
` CHECK INTERPRETER: Thank you.
` THE WITNESS: Yes.
`BY MR. ABE:
`
` Q. Q. Did you review any materials that is
`
` Q. Q.
`
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`Page 5
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`

`
`Confidential - Subject to The Protective Order
`Shirou Sawa - March 1, 2016
`
`Page 18
`
`not contained in your declaration that you
`submitted?
` MR. DINER: Again, I'll caution
`the witness to only answer that question yes or no.
` THE WITNESS: No.
`BY MR. ABE:
`
` Q. Q. Mr. Sawa, are you aware that there are
`
` Q. Q.
`several other witnesses for -- that are testifying
`on behalf of Senju in this proceeding?
` MR. DINER: Objection. Calls for
`speculation.
` THE WITNESS: I don't know.
` MR. ABE: Okay. Why don't we hand
`you what's been marked as Senju Exhibit 2098 in IPR
`2015-00902, and my understanding is the copy that
`counsel just handed me for the 903 proceeding is the
`same?
` MR. DINER: That's correct.
` MR. ABE: Okay.
` MR. DINER: Thanks, James.
` MR. ABE: I have one more copy if
`you need one.
`
`Page 19
`
` MR. HASFORD: Sure. If you got an
`extra copy. Thank you. Thanks, James.
` THE INTERPRETER: James, I'm going
`to need a copy of this.
` MR. ABE: Oh, okay. The
`witness -- the interpreter needs a copy. Can we
`have a copy?
` MR. HASFORD: You need this one
`back?
` MR. ABE: Sorry.
` MR. HASFORD: No worries.
` MR. DINER: We're okay here. We
`have one.
` MR. ABE: Sorry. I should have
`printed a little more copies.
` MR. HASFORD: Don't worry about
`it.
`BY MR. ABE:
`
` Q. Q. Okay. Mr. Sawa, is this your
`
` Q. Q.
`declaration?
` Well, why don't you turn to the second
`page of Exhibit 2098.
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`6 (Pages 18 to 21)
`
`Page 20
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` Well, actually, Mr. Sawa, do you speak
`English?
`
` A. A. No, I don't.
`
` A. A.
`
` Q. Q. Okay. So you should turn to page 15 of
`
` Q. Q.
`your declaration.
`
` A. A. Yes.
`
` A. A.
`
` Q. Q. Is this your declaration that you've
`
` Q. Q.
`submitted in these IPR -- IPR proceedings?
` MR. DINER: Mr. Sawa, you should
`take your time to look at the document before
`answering counsel's question.
` MR. ABE: And for the record, I'll
`note that page 15 is the translation of page 2 of
`Exhibit 2098.
` MR. DINER: James, would you like
`him just to look at the declaration part in
`answering your question?
` MR. ABE: For this part, I think
`that's -- that would be fine.
` Ask the witness to look through
`page 15 through 27 where his signature is.
` THE WITNESS: Yes.
`
`Page 21
`
`BY MR. ABE:
`
` Q. Q. Okay. So at the bottom of page 27,
`
` Q. Q.
`that is your signature dated December 16, 2015?
`
` A. A. Yes.
`
` A. A.
`
` Q. Q. Now, in preparing your declaration, did
`
` Q. Q.
`you consider any materials other than what's
`attached to your declaration as appendices?
` MR. DINER: Objection. Vague.
`Calls for speculation.
` THE WITNESS: I don't recall.
`BY MR. ABE:
`
` Q. Q. Mr. Sawa, if you turn to paragraph 3 of
`
` Q. Q.
`your declaration. Okay.
`
` A. A. Yes.
`
` A. A.
`
` Q. Q. It says you graduated from the
`
` Q. Q.
`University of Tokushima and received a bachelor's in
`Department of Chemical Engineering in the Faculty of
`Engineering.
` Do you see that?
`
` A. A. Yes.
`
` A. A.
`
` Q. Q. And it also says you received a
`
` Q. Q.
`master's degree in engineering with a chemical
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`Page 22
`
`engineering specialization from the same university?
`
` A. A. Yes.
`
` A. A.
`
` Q. Q. Did any of your courses you took during
`
` Q. Q.
`either time at the university specialize in
`pharmaceutical formulation?
`
` A. A. No.
`
` A. A.
`
` Q. Q. Did you take any courses that covered
`
` Q. Q.
`preservative efficacy testing?
` MR. DINER: Objection. Calls for
`speculation.
` THE WITNESS: I don't know.
`BY MR. ABE:
`
` Q. Q. Did you take any courses in
`
` Q. Q.
`microbiology?
` MR. DINER: The same objection.
` THE WITNESS: No.
`BY MR. ABE:
`
` Q. Q. Was there a focus area in your study
`
` Q. Q.
`during your time at Tokushima University?
`
` A. A. Physical chemistry.
`
` A. A.
` CHECK INTERPRETER: The check
`interpreter for Senju asks: Could the lead
`
`Page 23
`
`interpreter speak up a little? She's having a hard
`time hearing you. Thank you.
`BY MR. ABE:
`
` Q. Q. If you'd now turn to paragraph 7 of
`
` Q. Q.
`your declaration, Mr. Sawa.
`
` A. A. Yes.
`
` A. A.
`
` Q. Q. Okay. It says that table, the table
`
` Q. Q.
`below contains the formulations from Table 1 of the
`patents.
` Do you see that?
` Let me withdraw the question.
` THE INTERPRETER: Okay.
` MR. ABE: Let me -- I'll hand the
`witness what's been marked as InnoPharma EX1001
`in -- this must be the 902 IPR proceeding.
` This is the...
` MR. DINER: Are you going to mark
`these?
` MR. ABE: I don't. I think we're
`just using the --
` MR. HASFORD: It's marked.
` MR. ABE: -- IPR exhibit numbers.
`
`1
`2
`3
`4
`5
`6
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`
`7 (Pages 22 to 25)
`
`Page 24
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`
` MR. DINER: Okay. Fine.
` James, do you happen to have a
`Japanese version of this?
` MR. ABE: No, I do not.
` I won't get into the details.
` One second.
` For the record, EX1001 is the
`8,669,290 patent, and I'll refer to it as the '290
`patent.
` THE WITNESS: Okay.
`BY MR. ABE:
`
` Q. Q. Mr. Sawa, you -- you're familiar with
`
` Q. Q.
`this patent?
` MR. DINER: Objection. Vague.
`The exhibit is in English and the witness has stated
`that he doesn't speak English or read English.
` THE WITNESS: I have seen it.
`BY MR. ABE:
`
` Q. Q. And on paragraph 7, you state that you
`
` Q. Q.
`prepared and tested the stability of the bromfenac
`sodium formulations disclosed in Table 1 of the '431
`and '290 patents.
`
`Page 25
`
` Do you see that?
`
` A. A. Yes.
`
` A. A.
`
` Q. Q. The '290 patent that you reference
`
` Q. Q.
`there is what I handed you as Exhibit 1001; is that
`right?
`
` A. A. Yes.
`
` A. A.
`
` Q. Q. On the second sentence of paragraph 7
`
` Q. Q.
`of your declaration, you say that you prepared
`additional formulations with varying amounts of
`tyloxapol.
` Do you see that?
`
` A. A. Yes.
`
` A. A.
`
` Q. Q. Do you remember why you were trying
`
` Q. Q.
`different amounts of tyloxapol?
` MR. DINER: Objection. Calls for
`speculation.
` THE WITNESS: You're referring to
`the things in the declaration; correct?
`BY MR. ABE:
`
` Q. Q. Yes, your declaration and the documents
`
` Q. Q.
`that are attached to your declaration.
` MR. DINER: Same objection. Calls
`
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`Shirou Sawa - March 1, 2016
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`
`for speculation.
` THE WITNESS: I don't recall.
`BY MR. ABE:
`
` Q. Q. On paragraph 8, the first sentence, it
`
` Q. Q.
`says you adjusted the pH of the formulations to 7.
` Do you see that?
`
` A. A. Yes.
`
` A. A.
`
` Q. Q. Do you recall why you adjusted the pH
`
` Q. Q.
`of the formulation to 7?
` MR. DINER: Objection. Calls for
`speculation.
` THE WITNESS: I don't recall.
`BY MR. ABE:
`
` Q. Q. Do you -- start over.
`
` Q. Q.
` After paragraph 8, there are parameters
`listed for an HPLC method.
` Do you see that?
`
` A. A. Yes.
`
` A. A.
`
` Q. Q. Do you know why these parameters were
`
` Q. Q.
`used for the HPLC?
`
` A. A. I don't recall.
`
` A. A.
`
` Q. Q. So you don't know why the UV absorbance
`
` Q. Q.
`
`Page 27
`
`spectroscopy was set to 266 nanometers?
`
` A. A. No, I don't recall.
`
` A. A.
`
` Q. Q. And for any of the other listed
`
` Q. Q.
`conditions, is your answer the same?
`
` A. A. Yes.
`
` A. A.
`
` Q. Q. On paragraph 9, the second sentence,
`
` Q. Q.
`you state that you took into account the amount of
`water evaporation from the formulation.
` Let me -- let me state -- state the
`whole sentence.
` On paragraph 9, second sentence, you
`say:
` "The percent of bromfenac sodium
`remaining was adjusted to take into account the
`amount of water evaporation from the formulation."
` Do you see that?
`
` A. A. Yes.
`
` A. A.
`
` Q. Q. Okay. Why was there water evaporation?
`
` Q. Q.
` MR. DINER: Objection.
`Mischaracterizes the document. Calls for
`speculation.
` THE WITNESS: I don't know.
`
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`8 (Pages 26 to 29)
`
`Page 28
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`
`BY MR. ABE:
`
` Q. Q. Do you know if the water evaporation
`
` Q. Q.
`was happening during the storage at 60 degrees
`Celsius for four weeks?
` MR. DINER: Objection. No
`foundation. Mischaracterizes the document.
` THE WITNESS: I don't know.
`BY MR. ABE:
`
` Q. Q. You state in that same -- same sentence
`
` Q. Q.
`that you adjusted something to take into account the
`amount of water evaporation.
` My question is: What did you adjust?
` Or sorry. Let me start over.
` How did you adjust the percent of
`bromfenac sodium remaining?
`
` A. A. What do you mean "adjust"?
`
` A. A.
`
` Q. Q. Well, your declaration says that you
`
` Q. Q.
`adjusted. So I'm just asking how you adjusted.
`
` A. A. I don't recall.
`
` A. A.
`
` Q. Q. Can you take a look at the table that
`
` Q. Q.
`follows paragraph 9 in your declaration.
`
` A. A. Yes.
`
` A. A.
`
`Page 29
`
`
` Q. Q. On the column that lists the
`
` Q. Q.
`composition for formulation code A-20.
` Can you see that?
`
` A. A. Which code? Sorry.
`
` A. A.
`
` Q. Q. Yes, formulation code.
`
` Q. Q.
`
` A. A. Yes.
`
` A. A.
`
` Q. Q. And one of the listed components is
`
` Q. Q.
`polysorbate 80; right?
`
` A. A. Yes.
`
` A. A.
`
` Q. Q. Can you hold that page and turn to page
`
` Q. Q.
`347.
` MR. ABE: And for counsel, page
`173 I believe is the corresponding English page.
` THE WITNESS: Yes.
` MR. DINER: Hold on one second,
`James, until we get there.
` 173 for the English version?
` MR. ABE: Yes. The English
`version, I believe, is 173.
` MR. DINER: Appendix A; right?
` MR. ABE: Appendix A, yes.
` And the original Japanese, if I
`
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`
`have this correctly, is 347.
`BY MR. ABE:
`
` Q. Q. Okay. Now, the formulation number
`
` Q. Q.
`A-20, is that the same that's listed on page 347 as
`the one listed on your declaration, the table of
`your declaration?
`
` A. A. Yes.
`
` A. A.
`
` Q. Q. Okay. If you compared the amount of
`
` Q. Q.
`polysorbate 80 between what's said in your
`declaration and what's shown on page 347, they're
`not the same, are they?
` MR. DINER: Objection.
`Mischaracterizes the document.
` THE WITNESS: Which part are you
`referring to?
`BY MR. ABE:
`
` Q. Q. Sure. So on table -- the table of your
`
` Q. Q.
`declaration, for formulation code A-20, the amount
`of polysorbate 80 is 0.17 grams; right?
`
` A. A. You said .187?
`
` A. A.
`
` Q. Q. I said .17.
`
` Q. Q.
`
` A. A. Yes, that's correct.
`
` A. A.
`
`Page 31
`
`
` Q. Q. Okay. But looking at page 347 of
`
` Q. Q.
`Appendix A, can you tell me what the amount of
`polysorbate 80 is there?
` MR. DINER: Objection. Vague.
` THE WITNESS: 0.167.
`BY MR. ABE:
`
` Q. Q. So the amount shown as the weighed
`
` Q. Q.
`amount, that's the actual amount that you added?
`
` A. A. That's correct.
`
` A. A.
`
` Q. Q. So looking at page 347 again, was the
`
` Q. Q.
`initial plan to add 0.15 grams of polysorbate 80?
` MR. DINER: Objection. Vague.
` THE WITNESS: That's what it says
`here.
`BY MR. ABE:
`
` Q. Q. But you actually added 0.167 grams;
`
` Q. Q.
`right?
`
` A. A. That's what it says.
`
` A. A.
`
` Q. Q. Do you know why you added more than you
`
` Q. Q.
`initially planned?
`
` A. A. I don't recall.
`
` A. A.
`
` Q. Q. And just to confirm, on page 347, which
`
` Q. Q.
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`9 (Pages 30 to 33)
`
`Page 32
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`again corresponds to page 173 of Appendix A, that's
`your name at the -- as the tester?
`
` A. A. Yes.
`
` A. A.
`
` Q. Q. Now, the table on page 347, it doesn't
`
` Q. Q.
`say -- well, strike that.
` On page 347, for formulation A-20, can
`you tell me how much -- what the volume of the
`formulation was?
`
` A. A. I don't recall.
`
` A. A.
`
` Q. Q. What about for formulation A-21? Do
`
` Q. Q.
`you know what the volume of that formulation is?
`
` A. A. I don't recall.
`
` A. A.
`
` Q. Q. Turning back to the table of your
`
` Q. Q.
`declaration that has the formulations A-20 and 21,
`can you take a look at that?
`
` A. A. Yes.
`
` A. A.
`
` Q. Q. For formulation A-20 and A-21, the
`
` Q. Q.
`total amount is listed as 100 milliliters; right?
`
` A. A. Yes.
`
` A. A.
`
` Q. Q. How do you know it was 100 milliliters?
`
` Q. Q.
`
` A. A. (Pause). I don't know.
`
` A. A.
`
` Q. Q. Looking at that same table in your
`
` Q. Q.
`
`Page 33
`
`declaration, it lists the pH of the five
`formulations there.
` Do you see that?
`
` A. A. Yes.
`
` A. A.
` CHECK INTERPRETER: Chec