Transcript of the Testimony of M. Jayne Lawrence
`
`Date: May 3, 2016
`
`Case: Lupin Ltd. and Lupin Pharmaceuticals Inc. v. Senju
`Pharmaceutical Co., Ltd.
`
`Ace-Federal Reporters, Inc.
`Phone: 202-347-3700
`Fax: 202-737-3638
`Email: info@acefederal.com
`Internet: www.acefederal.com
`
`SENJU EXHIBIT 2342
`LUPIN v. SENJU
`IPR2015-01100
`
`Page 1 of 271
`
`
`
`Date: May 3, 2016
`
`Case: Lupin Ltd. and Lupin Pharmaceuticals Inc. v. Senju
`Pharmaceutical Co., Ltd.
`
`Ace-Federal Reporters, Inc.
`Phone: 202-347-3700
`Fax: 202-737-3638
`Email: info@acefederal.com
`Internet: www.acefederal.com
`
`SENJU EXHIBIT 2342
`LUPIN v. SENJU
`IPR2015-01100
`
`Page 1 of 271
`
`
`
`M. Jayne Lawrence
`
`Lupin Ltd. and Lupin Pharmaceuticals Inc. v. Senju Pharmaceutical Co., Ltd.
`
`May 3, 2016
`
`Page 1
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` UNITED STATES PATENT AND TRADEMARK OFFICE
` ____________________________________________________
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________________________________________________
` LUPIN LTD., and LUPIN PHARMACEUTICALS INC.
` Petitioner
` v.
` SENJU PHARMACEUTICAL CO., LTD.
` Patent Owner
` ____________________________________________________
` Inter Partes Review Nos.
` IPR2015-01097 (Patent 8,751,131)
` IPR2015-01099 (Patent 8,669,290)
` IPR2015-01100 (Patent 8,927,606)
` IPR2015-01105 (Patent 8,871,813)
`____________________________________________________
`
` DEPOSITION OF M. JAYNE LAWRENCE
`
` Washington, DC
` Tuesday, May 3, 2016
` REPORTED BY: SARA WICK, RPR, CRR
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`Page 2 of 271
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`M. Jayne Lawrence
`
`Lupin Ltd. and Lupin Pharmaceuticals Inc. v. Senju Pharmaceutical Co., Ltd.
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`May 3, 2016
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`Page 2
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` Deposition of M. JAYNE LAWRENCE, called for
` examination pursuant to notice of deposition on
` Tuesday, May 3, 2016, in Washington, DC, at the
` offices of Crowell & Moring LLP, 1001 Pennsylvania
` Avenue, NW, at 8:56 a.m., before SARA WICK, RPR, CRR
` and a Notary Public within and for the District of
` Columbia, when were present on behalf of the
` respective parties:
`
` SHANNON M. LENTZ, ESQ.
` DEBORAH H. YELLIN, ESQ.
` Crowell & Moring LLP
` 1001 Pennsylvania Avenue, NW
` Washington, DC 20004-2595
` 202-624-2897
` slentz@crowell.com
` dyellin@crowell.com
` On behalf of Petitioner
`
` -- continued --
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`M. Jayne Lawrence
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`Lupin Ltd. and Lupin Pharmaceuticals Inc. v. Senju Pharmaceutical Co., Ltd.
`
`May 3, 2016
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`Page 3
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` APPEARANCES (Continued):
`
` JUSTIN J. HASFORD, ESQ.
` Finnegan, Henderson, Farabow, Garrett
` & Dunner, L.L.P.
` 901 New York Avenue, NW
` Washington, DC 20001-4413
` 202-408-4175
` justin.hasford@finnegan.com
` On behalf of Patent Owner
`
` ALSO PRESENT: Bradley Moore, Larry Flowers
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`M. Jayne Lawrence
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`Lupin Ltd. and Lupin Pharmaceuticals Inc. v. Senju Pharmaceutical Co., Ltd.
`
`May 3, 2016
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` P R O C E E D I N G S
` VIDEOGRAPHER: Good morning.
` We are now on the record.
` Please note that microphones are sensitive
` and may pick up whispering and private
` conversations. Please turn off all cell phones or
` place them away from the microphones, as they can
` interfere with the deposition audio. Recording will
` continue until the parties agree to go off the
` record.
` This is the deposition of Dr. Jayne
` Lawrence, in the matter of Lupin, Limited, and Lupin
` Pharmaceuticals, Inc., et al., Petitioner, versus
` Senju Pharmaceutical Company, Limited, et al.,
` Patent Owner, Case Numbers IPR2015-01097,
` IPR2015-01100, IPR2015-01105, IPR2015-01099, before
` the United States Patent and Trademark Office,
` Patent Trial and Appeals Board.
` This deposition is being taken at Crowell
` & Moring LLP, 1001 Pennsylvania Avenue Northwest,
` Washington, D.C. The time is approximately 8:56
` a.m. The date today is May 3rd, 2016. The court
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`M. Jayne Lawrence
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`Lupin Ltd. and Lupin Pharmaceuticals Inc. v. Senju Pharmaceutical Co., Ltd.
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`May 3, 2016
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` reporter is Sara Wick with the firm of Ace-Federal
` Reporters, Inc., I am the video operator, Larry
` Flowers, also with Ace-Federal, 1625 I Street
` Northwest, Suite 790, Washington, D.C. 20006.
` Will all counsel identify themselves and
` who they represent.
` MR. HASFORD: Justin Hasford of Finnegan
` for Patent Owner Senju, and with me here is my
` colleague, Bradley Moore, also from Finnegan.
` MS. LENTZ: Shannon Lentz of Crowell &
` Moring on behalf of Petitioners. With me here today
` is Deborah Yellin, also of Crowell.
` Whereupon,
` M. JAYNE LAWRENCE
` was called as a witness and, having first been duly
` sworn, was examined and testified as follows:
` CROSS-EXAMINATION
` BY MR. HASFORD:
` Q Good morning, Dr. Lawrence.
` A Good morning.
` Q Would you, please, state your name and
` address for the record.
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`M. Jayne Lawrence
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`Lupin Ltd. and Lupin Pharmaceuticals Inc. v. Senju Pharmaceutical Co., Ltd.
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`May 3, 2016
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` A Margaret Jayne Lawrence. I live at 62
` Wellington Road, Ashford, Middlesex, U.K.
` Q I represent the Patent Owner Senju in
` these IPR proceedings, as you are aware. Today I
` will ask you questions, and all I ask is that you
` answer my questions truthfully and accurately. If
` you need a break, just let me know. But if a
` question is pending, please first answer the
` question, and then we can take a break. If for any
` reason you do not understand a question that I ask,
` please let me know. If you answer a question, I
` will assume that you understood the question.
` Is that okay?
` A Yes.
` Q Is there any reason why you cannot testify
` truthfully and accurately today?
` A No.
` Q For the record, I am handing Dr. Lawrence
` and Petitioner's counsel copies of Exhibit 2324
` entitled "PATENT OWNER'S NOTICE OF CROSS-EXAMINATION
` OF DR. JAYNE LAWRENCE."
` (Exhibit 2324 marked for identification.)
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`M. Jayne Lawrence
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`Lupin Ltd. and Lupin Pharmaceuticals Inc. v. Senju Pharmaceutical Co., Ltd.
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`May 3, 2016
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`Page 7
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` MR. HASFORD: For the record, I am also
` handing Dr. Lawrence and Petitioner's counsel copies
` of Exhibit 2325 entitled "PATENT OWNER'S NOTICE OF
` CROSS-EXAMINATION OF DR. JAYNE LAWRENCE."
` (Exhibit 2325 marked for identification.)
` THE WITNESS: Thank you.
` MR. HASFORD: Counsel, can we stipulate
` that Dr. Lawrence is here today pursuant to Exhibits
` 2324 and 2325?
` MS. LENTZ: Yes, we can.
` MR. HASFORD: Okay. You may put those
` aside.
` Can we also stipulate that the questions
` that I ask, unless otherwise stated, apply equally
` to the four IPRs, IPR2015-01097, IPR2015-01099,
` IPR2015-01100, and IPR2015-01105.
` MS. LENTZ: Yes, we can.
` MR. HASFORD: Thank you.
` For the record, I am handing Dr. Lawrence
` and Petitioner's counsel copies of Exhibit 1094
` entitled "REPLY DECLARATION OF M. JAYNE LAWRENCE,
` PH.D."
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`M. Jayne Lawrence
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`Lupin Ltd. and Lupin Pharmaceuticals Inc. v. Senju Pharmaceutical Co., Ltd.
`
`May 3, 2016
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`Page 8
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` (Exhibit 1094 marked for identification.)
` BY MR. HASFORD:
` Q Is Exhibit 1094 your reply declaration in
` these IPR proceedings concerning U.S. Patent Numbers
` 8,669,290, 8,754,131, 8,871,813, and 8,927,606?
` A Yes, it is.
` Q If I refer to U.S. patent numbers
` 8,669,290, 8,754,131, 8,871,813, and 8,927,606 as
` the '290, '131, '813, and '606 patents respectively,
` will you understand what I mean?
` A Yes, I will.
` Q If I refer to the '290, '131, '813, and
` '606 patents collectively as the patents at issue,
` will you understand what I mean?
` A Yes, I will.
` Q Please turn to page 59 of your reply
` declaration. Do you see your electronic signature
` on page 59 of your reply declaration?
` A Yes, I do.
` Q You did not actually write your reply
` declaration for these IPR proceedings; correct?
` MS. LENTZ: Objection.
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`M. Jayne Lawrence
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`Lupin Ltd. and Lupin Pharmaceuticals Inc. v. Senju Pharmaceutical Co., Ltd.
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`May 3, 2016
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` Go ahead. You can answer.
` THE WITNESS: Okay. I didn't type every
` word, obviously, but everything I have in here are
` my thoughts, my ideas, and I stand by everything
` that's said in here.
` BY MR. HASFORD:
` Q Why didn't you type your reply
` declaration?
` A Because it was worked on between myself
` and counsel here.
` Q Please turn to paragraph 4 on page 4 of
` your reply declaration. In paragraph 4 of your
` reply declaration, you set forth the fields in which
` you believe yourself to be an expert; correct?
` A Some of the fields, yes, yes.
` Q You provided opinions about various
` chemistry issues in your reply declaration. Yet,
` you have never been qualified by any court or by the
` U.S. Patent and Trademark Office as an expert in
` chemistry; correct?
` A I believe I was qualified by -- in
` chemistry in the recent court case.
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`May 3, 2016
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`Page 10
` MR. HASFORD: For the record, I am handing
` Dr. Lawrence and Petitioner's counsel Exhibit 2326,
` which is the full transcript of the trial in the
` parallel district court litigation, Senju, et al.,
` v. Lupin, et al., before the Honorable Jerome
` Simandle, United States District Court for the
` District of New Jersey.
` (Exhibit 2326 marked for identification.)
` BY MR. HASFORD:
` Q Doctor, Exhibit 2326 is the transcript
` from trial. Turn, if you would, to page 1225.
` A Can I just say I haven't seen this
` document before?
` Q Okay. I will show you your testimony.
` A What page?
` Q 1225. Let me direct your attention to
` line 18.
` A Line 18, page 1225.
` Q Page 1225, line 18.
` A Yes, I do.
` Q I asked you a question "You testified" on
` "direct exam about various chemistry issues. Do you
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` remember that?"
` And you answered "Yes, I do."
` Then I asked "Question: You have never
` been qualified by any court or by the U.S. Patent
` and Trademark Office as an expert in chemistry,
` correct?"
` And you answered "No, I have not."
` Those were the exact questions that I
` asked you, and those were the exact answers that you
` gave; correct?
` A I can see that, yes.
` Q You may put that document aside. You are
` not an expert in medicinal chemistry; correct?
` A That is correct, yes.
` Q You are not an expert in organic
` chemistry; correct?
` A That is correct, yes.
` Q You are not an expert in antioxidant
` chemistry; correct?
` A Yes, that's correct.
` Q You are not a member of the American
` Chemical Society; correct?
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`May 3, 2016
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` A That is correct, yes.
` Q You have never published anything in the
` Journal of the American Chemical Society; correct?
` A Not in the Journal of the American
` Chemical Society. But obviously, as I've explained
` before, in Journal of the American Chemical Society,
` yes.
` Q Take a look, if you would, at your trial
` transcript again. And let me direct your attention
` to page 1226 this time. And in particular to line
` 7. Let me know when you're there.
` A Yes, I'm there.
` Q I asked you "Question: You have never"
` published "anything in the Journal of the American
` Chemical Society, correct?"
` And you answered "Not in JACS, no."
` That was the exact question that I asked,
` and that was the exact answer that you gave;
` correct?
` A That's correct, and it's not inconsistent
` with what I just said.
` Q You may put that aside. You have never
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` earned a bachelor's degree in chemistry; correct?
` A That is correct, yes.
` Q You have never earned a master's degree in
` chemistry; correct?
` A I don't have any master's degree.
` Q You provided opinions about various
` medical issues in your reply declaration. Yet, you
` are not an expert in ophthalmology; correct?
` A That's correct. I'm not an expert in
` ophthalmology.
` Q You do not practice medicine and have
` never prescribed medication to a patient; correct?
` A I don't practice medicine. I'm not a
` medic. And I have not actually got prescribing
` rights, that's correct.
` Q You have never treated an inflammatory
` disease of the eye; correct?
` A Not by prescribing meds, no.
` Q You have not dispensed any medication to
` any patient in the last 20 years; correct?
` A That's probably correct, yes.
` Q You have never dispensed any bromfenac
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`Lupin Ltd. and Lupin Pharmaceuticals Inc. v. Senju Pharmaceutical Co., Ltd.
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`May 3, 2016
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` product to a patient; correct?
` A That is my understanding, yes.
` Q You have never conducted any research on
` any bromfenac product; correct?
` A Yes, that is correct.
` Q Aside from your work in this case and the
` parallel district court case, you have never
` consulted for any party regarding any bromfenac
` product; correct?
` A Yes, that is correct.
` Q If bromfenac were not expected to be
` superior to diclofenac, would the exhibited success
` of diclofenac encourage a person of ordinary skill
` in the art to formulate ophthalmic solutions with
` diclofenac or bromfenac?
` MS. LENTZ: Objection; compound, vague.
` THE WITNESS: Could you repeat the
` question, please?
` BY MR. HASFORD:
` Q Certainly. If bromfenac were not expected
` to be superior to diclofenac, would the exhibited
` success of diclofenac encourage a person of ordinary
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` skill in the art to formulate ophthalmic solutions
` with diclofenac or bromfenac?
` A I'm taking that -- I don't really
` understand the question that you're asking me there.
` It seems to have several components, and I'm not too
` sure what you're asking.
` Q Suppose bromfenac were not expected to be
` superior to diclofenac. Do you understand that
` part?
` A Yes, vaguely, yes.
` Q Under those circumstances, would the
` exhibited success of diclofenac encourage a person
` of ordinary skill in the art to formulate ophthalmic
` solutions with diclofenac or bromfenac?
` MS. LENTZ: Same objections.
` THE WITNESS: I really don't have enough
` information to answer that. What I will say,
` however, it's important for patients, because we're
` all different, to have several NSAIDs on the market,
` because one might suit them better than another,
` just as the same idea as having several pain killers
` on the market. That's the best way I can answer
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` that question. I'm sorry.
` BY MR. HASFORD:
` Q You provided opinions about various
` marketing issues in your reply declaration. Yet,
` you have never formulated any marketed drug product;
` correct?
` MS. LENTZ: Objection in that it calls --
` mischaracterizes testimony.
` THE WITNESS: I'm answering the part of
` that question that seems to ask whether I've
` actually produced any marketed products, and no, I
` haven't.
` BY MR. HASFORD:
` Q You have never formulated any product for
` treating an inflammatory disease of the eye;
` correct?
` A Not personally, no.
` Q You have never founded or cofounded a
` pharmaceutical services company; correct?
` A I am taking "services" in this context to
` mean -- I'm taking it to mean people hire a company
` to do formulation or hire a company to do some
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` pharmaceutical work, because I'm not -- it's not a
` term that we use in the U.K. And no, I haven't been
` involved in doing that.
` Q You have never led any clinical testing on
` a pharmaceutical product; correct?
` A No. I've been involved in clinical
` trials, but not led, no.
` Q You have never designed any clinical
` testing on a pharmaceutical product; correct?
` A No, I have not.
` Q You are not an expert in statistics or
` biostatistics; correct?
` A No. As I said before, I'm not an expert,
` but obviously, in my research, I have to use it. So
` I'm competent with statistics.
` MR. HASFORD: For the record, I'm handing
` Dr. Lawrence and Petitioner's counsel copies of
` Exhibit 2140, which is the "Transcript of the
` Testimony of M. Jayne Lawrence" dated September 4th,
` 2015.
` (Exhibit 2140 marked for identification.)
` THE WITNESS: Thank you.
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`Page 18 of 271
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`M. Jayne Lawrence
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`Lupin Ltd. and Lupin Pharmaceuticals Inc. v. Senju Pharmaceutical Co., Ltd.
`
`May 3, 2016
`
`Page 18
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` MR. HASFORD: You're welcome.
` BY MR. HASFORD:
` Q Uh-huh. You're welcome.
` Turn, Doctor, to page 37. Let me direct
` your attention to lines 15 through 17. I asked you:
` "Question: Do you hold yourself to the public as an
` expert in statistics or biostatistics?"
` And you answered "No, I would not."
` That was the exact question that I asked,
` and that was the exact answer that you gave;
` correct?
` A That is correct. If you go a few lines
` ahead, I also qualified, as I have just done now,
` that I have a good understanding of statistics.
` Q You didn't qualify the specific answer
` that you gave to the specific question that I asked
` at lines 15 through 17; correct?
` A That is correct, but I previously just sat
` back and qualified it.
` Q You are not an expert in the European
` Pharmacopeia criteria B standards; correct?
` A I don't hold myself out to be an expert in
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`
`M. Jayne Lawrence
`
`Lupin Ltd. and Lupin Pharmaceuticals Inc. v. Senju Pharmaceutical Co., Ltd.
`
`May 3, 2016
`
`Page 19
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` the standard, no.
` Q You have never contributed to the content
` of any addition of the European pharmacopeia;
` correct?
` A Yes, that is correct.
` Q You have never contributed to the content
` of any edition of the United States Pharmacopeia;
` correct?
` A Yes, that is correct.
` Q You are aware that the United States
` Pharmacopeia is a publication of the national
` formulary; correct?
` A Yes, I am.
` Q You have never consulted for the national
` formulary; correct?
` A No, I have not.
` Q You have never consulted for the FDA;
` correct?
` A Yes, I have not -- sorry. I have not
` consulted for the FDA.
` Q You provided various opinions about
` regulatory issues in your reply declaration. Yet,
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`Page 20 of 271
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`
`M. Jayne Lawrence
`
`Lupin Ltd. and Lupin Pharmaceuticals Inc. v. Senju Pharmaceutical Co., Ltd.
`
`May 3, 2016
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`Page 20
` you have never been qualified by any court or by the
` U.S. Patent and Trademark Office as an expert in
` regulatory law; correct?
` MS. LENTZ: Objection; vague.
` THE WITNESS: I've never been asked by
` anybody to give a regulatory opinion in -- to be an
` expert in regulatory, that's correct.
` BY MR. HASFORD:
` Q You have never consulted for any party on
` any issue of FDA regulatory law; correct?
` MS. LENTZ: Objection; vague.
` THE WITNESS: Yes, that is correct.
` BY MR. HASFORD:
` Q You are not an expert in pharmacology;
` correct?
` A Yes, that is correct.
` Q You are not an expert in pharmacokinetics;
` correct?
` A No, I don't hold myself out to be an
` expert, but as with every pharmaceutical scientist,
` we have a basic understanding of pharmacokinetics.
` Q Take a look again, if you would, at your
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`202-347-3700
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`Page 21 of 271
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`
`M. Jayne Lawrence
`
`Lupin Ltd. and Lupin Pharmaceuticals Inc. v. Senju Pharmaceutical Co., Ltd.
`
`May 3, 2016
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`Page 21
` September 4th, 2015, transcript. Let me direct your
` attention to page 26 and, in particular, lines 5
` through 7. I asked you:
` "Question: Have you ever held yourself
` out to the public as an expert in pharmacokinetics?"
` And you answered "No."
` That was the exact question that I asked
` you and that was exact answer that you gave; right?
` MS. LENTZ: Objection; improper
` impeachment.
` THE WITNESS: Well, I stand by that. But
` I've never held myself out as an expert. I
` obviously use pharmacokinetics.
` BY MR. HASFORD:
` Q You didn't qualify your answer at your
` deposition, did you, Doctor?
` A I'm giving you a more full answer now.
` Q You are not an expert in pharmacodynamics;
` correct?
` A No, I've never held myself out to be an
` expert in pharmacodynamics.
` Q You are not an expert in bioavailability;
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`202-347-3700
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`Page 22 of 271
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`
`
`M. Jayne Lawrence
`
`Lupin Ltd. and Lupin Pharmaceuticals Inc. v. Senju Pharmaceutical Co., Ltd.
`
`May 3, 2016
`
`Page 22
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` correct?
` A I have not held myself out to be an expert
` in bioavailability.
` Q You are not an expert in toxicology;
` correct?
` A I have not held myself out to be an expert
` in toxicology.
` Q You are not an expert in patent law;
` correct?
` A That is correct, yes.
` Q You are not a named inventor on any U.S.
` patents or U.S. patent applications; correct?
` A Yes, that is correct.
` Q You only ever filed two non-U.S. patent
` applications; correct?
` A Yes, that is correct.
` Q You have never filed a patent application
` dealing with the use of bromfenac in a
` pharmaceutical formulation; correct?
` A Yes, that is correct.
` Q You have never filed a patent application
` dealing with the use of tyloxapol in a
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`Ace-Federal Reporters, Inc.
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`202-347-3700
`
`Page 23 of 271
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`
`M. Jayne Lawrence
`
`Lupin Ltd. and Lupin Pharmaceuticals Inc. v. Senju Pharmaceutical Co., Ltd.
`
`May 3, 2016
`
`Page 23
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` pharmaceutical formulation; correct?
` A Yes, that is correct.
` Q You have never filed a patent application
` dealing with the use of benzalkonium chloride in a
` pharmaceutical formulation; correct?
` A That is correct.
` Q You have never filed a patent application
` dealing with formulating a stable aqueous liquid
` preparation; correct?
` A Yes, that is correct.
` Q Please turn to page 7 in your reply
` declaration. And let me direct your attention to
` heading 5 toward the middle of the page. You
` provided opinions about the Ogawa '225 patent in
` your reply declaration. Do you see that?
` A Yes, I do.
` Q In your opinion, to the extent there was
` even any need for the claimed bromfenac ophthalmic
` formulations claimed in the '290, '131, '813, and
` '606 patents, you would state that that need would
` have been met by the disclosures of the Ogawa '225
` patent and Hara, each of which purport to describe
`
`866-928-6509
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`Ace-Federal Reporters, Inc.
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`202-347-3700
`
`Page 24 of 271
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`
`
`M. Jayne Lawrence
`
`Lupin Ltd. and Lupin Pharmaceuticals Inc. v. Senju Pharmaceutical Co., Ltd.
`
`May 3, 2016
`
`Page 24
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` stable ophthalmic bromfenac formulations; correct?
` A I need to hear the last part of that
` question again, please.
` Q I'm happy to repeat it for you.
` A It was very long.
` Q In your opinion, to the extent there was
` even any need for the claimed bromfenac ophthalmic
` formulations claimed in the '290, '131, '813, and
` '606 patents, you would state that that need would
` have been met by the disclosures of the Ogawa '225
` patent and Hara, each of which purport to describe
` stable ophthalmic bromfenac formulations; correct?
` A Okay. Can you point me to where I said
` that, please?
` MR. HASFORD: Certainly. For the record,
` I am handing Dr. Lawrence and Lupin's counsel copies
` of Exhibit 2327, which is the transcript of the
` testimony of M. Jayne Lawrence, dated February 29th,
` 2016.
` (Exhibit 2327 marked for identification.)
` THE WITNESS: Thank you very much.
` MR. HASFORD: You're welcome.
`
`866-928-6509
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`202-347-3700
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`Page 25 of 271
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`
`M. Jayne Lawrence
`
`Lupin Ltd. and Lupin Pharmaceuticals Inc. v. Senju Pharmaceutical Co., Ltd.
`
`May 3, 2016
`
`Page 25
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` BY MR. HASFORD:
` Q You're welcome. Turn, if you would, to
` page 139, and let me direct your attention to line
` 6. Are you there?
` A Okay. This is an extract from my report,
` is it?
` Q I asked you:
` "Question: You state that, 'To the extent
` there was even any need for the claimed bromfenac
` ophthalmic formulations claimed in the asserted
` claims of the asserted patents,' it is your 'opinion
` that that need would have been met by the
` disclosures of the '225 patent and Hara,' each of
` which purport to describe stable ... ophthalmic
` formulations,' correct?"
` And you answered "Yes, that's correct."
` That was the exact question that I asked
` you, and that was the exact answer that you gave;
` correct?
` MS. LENTZ: Objection to the extent that
` it mischaracterizes the testimony. Counsel, I just
` note for the record you omitted the quotation marks,
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`866-928-6509
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`Ace-Federal Reporters, Inc.
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`202-347-3700
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`Page 26 of 271
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`
`M. Jayne Lawrence
`
`Lupin Ltd. and Lupin Pharmaceuticals Inc. v. Senju Pharmaceutical Co., Ltd.
`
`May 3, 2016
`
`Page 26
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` implying that it was cited from another source.
` BY MR. HASFORD:
` Q You may answer.
` A That's why I asked to see where I had
` written it, because this is taking some out of
` context. So I would like to see the context in
` which it was said. Because I was obviously reading
` something from pages 216 and 217 of the report I
` wrote.
` Q You never told me during this deposition
` that I was taking anything out of context, did you,
` Doctor?
` MS. LENTZ: Objection; mischaracterizes
` her testimony.
` THE WITNESS: I didn't say that you've
` necessarily taken it out of cone text. I would I
` would like to see the context in which it was
` written to answer that question.
` BY MR. HASFORD:
` Q I asked you the question at page 139,
` lines 6 through 13, and you gave me the answer at
` line 14; correct?
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`866-928-6509
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`
`M. Jayne Lawrence
`
`Lupin Ltd. and Lupin Pharmaceuticals Inc. v. Senju Pharmaceutical Co., Ltd.
`
`May 3, 2016
`
`Page 27
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` A It's very clear that this is a series of
` questions that are relating to something I had
` written in the report. So while clearly that is
` what is said in the report, without looking at the
` whole context, I'm really unwilling to comment on
` that.
` Q All I'm asking is if that was the question
` that I asked and that's the answer that you gave.
` A As I've said or as I thought I've said,
` obviously, that was a part of a series of questions
` on your part of which that is, obviously, typed down
` there. But it has got to be taken in context with
` what else is written there.
` Q You may put that document aside. In fact,
` it is your opinion that any need in the art for an
` aqueous preparation of an NSAID formulated with
` benzalkonium chloride for ophthalmic administration
` was already met by aqueous ophthalmic formulations
` of NSAIDs known as of January 21st, 2003; correct?
` MS. LENTZ: Objection to the extent it
` mischaracterizes prior testimony.
` THE WITNESS: Again, I would like to see
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`202-347-3700
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`Page 28 of 271
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`M. Jayne Lawrence
`
`Lupin Ltd. and Lupin Pharmaceuticals Inc. v. Senju Pharmaceutical Co., Ltd.
`
`May 3, 2016
`
`Page 28
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` the context in which that was written, please.
` BY MR. HASFORD:
` Q Take a look at Exhibit 2327 that we just
` looked at. And let me direct your attention to page
` 138, line 9. Are you there, Doctor?
` A 138, line 9, did you say?
` Q Uh-huh; yes.
` A Yes.
` Q I asked you:
` "Question: Why is it your opinion that
` any need for a aqueous liquid preparation of an
` NSAID formulated with benzalkonium chloride for
` ophthalmic administration was already met by aqueous
` ophthalmic formulations of NSAIDs known as of
` January 21, 2003?"
` There was an objection.
` I told you you may answer.
` And you answered "I guess the best analogy
` I can think of is that while we all might like new
` cars -- we might all like a new car, we don't
` necessarily need a new car. There are plenty of
` formulations on the market already that serve the
`
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`M. Jayne Lawrence
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`Lupin Ltd. and Lupin Pharmaceuticals Inc. v. Senju Pharmaceutical Co., Ltd.
`
`May 3, 2016
`
`Page 29
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` purpose."
` That was the question that I asked, and
` that was the answer you gave; correct?
` A The answer is the same as I had to the
` previous question. It
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