Mansoor Amiji - December 18, 2015
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` I N T H E U N I T E D S T A T E S D I S T R I C T C O U R T
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` F O R T H E D I S T R I C T O F D E L A W A R E
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` I C E U T I C A P T Y L T D a n d I R O K O )
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` P H A R M A C E U T I C A L S , L L C , )
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` P l a i n t i f f s , )
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` V S . ) C a s e N o . 1 4 - 1 5 1 5
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` L U P I N L I M I T E D a n d L U P I N ) ( S L R - S R F )
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` P H A R M A C E U T I C A L S , I N C . , )
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` D e f e n d a n t s . )
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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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` M A N S O O R A M I J I , R . P h . , P h . D .
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` F r i d a y , D e c e m b e r 1 8 , 2 0 1 5
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` I r v i n e , C a l i f o r n i a
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` R E P O R T E D B Y :
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` G R A C E C H U N G , C S R N o . 6 4 2 6 , R M R , C R R , C L R
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`GregoryEdwards, LLC | Worldwide Court Reporting
`GregoryEdwards.com | 866-4Team GE
`
`1
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`ICEUTICA 2003
`Lupin v. iCeutica
`IPR2016-00397
`
`

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`Mansoor Amiji - December 18, 2015
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`Page 2
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`1 I N D E X
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` WITNESS:
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`4 MANSOOR AMIJI, R.Ph., Ph.D.
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` EXAMINATION PAGE
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`5 6
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`7 BY MS. FLANAGAN 7
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` Videotaped Deposition of MANSOOR AMIJI,
`R.Ph., Ph.D., taken on behalf of Plaintiffs, at 2040
`Main Street, 14th Floor, Irvine, California,
`beginning at 9:04 a.m. and ending at 11:40 a.m., on
`Friday, December 18, 2015, before GRACE CHUNG, CSR
`No. 6246, RMR, CRR, CLR.
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`1 A P P E A R A N C E S
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`1 E X H I B I T S
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`Page 3
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`Page 5
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` NO. DESCRIPTION PAGE
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`2 3
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`4 Exhibit 1 Declaration of Dr. Mansoor M. Amiji 23
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`Exhibit 2 U.S. Patent 8,679,544 33
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`Exhibit 3 Document entitled "Mastersizer 3000 53
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`5 6
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`7 8
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`9 Smarter Particle Sizing"
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`10
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`11 Exhibit 4 Document entitled "Exhibit 12" 54
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`13 Exhibit 5 HPPS Operators Guide 68
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`16 QUESTIONS INSTRUCTED NOT TO ANSWER
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`17 PAGE LINE
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`For the Plaintiffs:
`4 FISH & RICHARDSON
`5 BY: ELIZABETH FLANAGAN, ESQ.
`6 222 Delaware Avenue
`7 17th Floor
`8 Wilmington, Delaware 19801
`9 (302) 778-8472
`10 eflanagan@fr.com
`11 (Via Videoconference)
`12
`13 For the Defendants:
`14 KNOBBE MARTENS
`15 BY: CHRISTY LEA, ESQ.
`16 BEN ANGER, ESQ.
`17 2040 Main Street
`18 14th Floor
`19 Irvine, California 92614
`20 (949) 760-0404
`21 christy.lea@knobbe.com
`22 ben.anger@knobbe.com
`23
`24 Also Present: KEITH FARRIS, Videographer
`25
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`GregoryEdwards, LLC | Worldwide Court Reporting
`GregoryEdwards.com | 866-4Team GE
`
`2
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`

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`Mansoor Amiji - December 18, 2015
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` Irvine, California
` Friday, December 18, 2015
` 9:04 a.m.
` THE VIDEOGRAPHER: Good morning. Here
` begins video disc number 1, volume 1, in the
` deposition of iCeutica Limited versus Iroko
` Pharmaceuticals -- strike that, iCeutica TTY [sic]
` Limited and Iroko Pharmaceuticals versus Lupin
` Limited and Lupin Pharmaceuticals.
` Today's date is December 18, 2015. The
` time is 9:04 a.m. this deposition is being taken at
` the firm of Knobbe Martens located at 2040 Main
` Street in Irvine, California, and was made at the
` request of the plaintiffs.
` My name is Keith Farris, the legal
` videographer and notary. The court reporter today is
` Ms. Grace Chung from Gregory Edwards, LLC.
` Would all counsel now please introduce
` yourselves and state whom you represent.
` MS. FLANAGAN: Elizabeth Flanagan with
` Fish and Richardson, PC, on behalf of the
` plaintiffs.
` MS. LEA: This is Christy Lea and Ben
` Anger from Knobbe Martens on behalf of the
` defendants and the witness.
`
`3 (Pages 6 to 9)
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` today; correct?
`
` A. A. Yes.
`
` A. A.
`
` Q. Q. I will do my best not to interrupt your
`
` Q. Q.
` answers. Will you please try to do the same and
` not interrupt my questions?
`
` A. A. Yes.
`
` A. A.
`
` Q. Q. Will you please do your best to answer
`
` Q. Q.
` verbally and without nodding or shaking your head?
`
` A. A. Okay.
`
` A. A.
`
` Q. Q. And if you answer my questions, can we
`
` Q. Q.
` assume that you understand them?
`
` A. A. Yes.
`
` A. A.
`
` Q. Q. If you need to make any modifications or
`
` Q. Q.
` corrections to the testimony during the day, please
` let me know, and I will give you an opportunity to
` do that on the record. Okay?
`
` A. A. Okay.
`
` A. A.
`
` Q. Q. And we can take a break about every hour
`
` Q. Q.
` or so. If you need to take a break sooner than
` that, let me know, and I will just ask that you
` finish answering any question that is pending.
` Okay?
`
` A. A. Okay.
`
` A. A.
`
` Q. Q. Is there any reason that you cannot
`
` Q. Q.
` provide complete and accurate and truthful
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`Page 9
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` testimony today?
`
` A. A. No, there isn't.
`
` A. A.
`
` Q. Q. Sir, you have a Ph.D. in pharmaceutics; is
`
` Q. Q.
` that correct?
`
` A. A. Yes.
`
` A. A.
`
` Q. Q. And you obtained that degree from Purdue
`
` Q. Q.
` University?
`
` A. A. Yes.
`
` A. A.
`
` Q. Q. Can you describe for me your -- in a
`
` Q. Q.
` general sense, your employment history since
` receiving your Ph.D.?
`
` A. A. So I finished my graduate degree at Purdue
`
` A. A.
` in 1992, and then I was first employed at Columbia
` Research Lab in Madison, Wisconsin, from July of
` 1992 to December of 1992. And then since January
` of '93, I came to Northeastern university in
` Boston, and I started as an assistant professor
` there, and I've been at Northeastern since.
`
` Q. Q. What kind of work did you do at Columbia
`
` Q. Q.
` Research Labs in general?
`
` A. A. Columbia Research Lab was a company that
`
` A. A.
` started out by a faculty member at University of
` Wisconsin, Madison, and they were interested in
` hydrogel-based drug delivery.
`
` Q. Q. And did you work in the lab during your
`
` Q. Q.
`
` MANSOOR AMIJI, R.Ph., Ph.D.,
` having been first duly sworn, was examined
` and testified as follows:
`
`Page 7
`
` EXAMINATION
` BY MS. FLANAGAN:
`
` Q. Q. Good morning, Dr. Amiji.
`
` Q. Q.
`
` A. A. Good morning.
`
` A. A.
`
` Q. Q. So we are taking this deposition with me
`
` Q. Q.
` via video and you there in person with a
` videographer. Please feel free to turn and look at
` me on the video screen if you would like.
` Otherwise, direct your attention at the video
` camera when you are answering your questions.
` Okay?
`
` A. A. Sure.
`
` A. A.
`
` Q. Q. You understand that you are under oath
`
` Q. Q.
` today, sir?
`
` A. A. Yes, I do.
`
` A. A.
`
` Q. Q. You understand that the testimony you are
`
` Q. Q.
` giving today is as if you are sitting in a
` courtroom; correct?
`
` A. A. Yes.
`
` A. A.
`
` Q. Q. You understand that there is a court
`
` Q. Q.
` reporter taking down my questions and your answers
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`GregoryEdwards, LLC | Worldwide Court Reporting
`GregoryEdwards.com | 866-4Team GE
`
`3
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`

`
`Mansoor Amiji - December 18, 2015
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`Page 10
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`4 (Pages 10 to 13)
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` time there?
`
` A. A. No. I worked with a company.
`
` A. A.
`
` Q. Q. Generally, what kind of tasks were you
`
` Q. Q.
` responsible for, if you recall?
`
` A. A. There are several different kinds of tests
`
` A. A.
` that we did. We looked into hydrogel delivery
` systems for both oral administration as well as
` other routes of administration, and we looked at
` drug release. We looked at various absorption
` profiles, properties of the hydrogel, especially in
` relation to the adhesiveness to tissues.
`
` Q. Q. Did you do any kind of postdoctorate work?
`
` Q. Q.
`
` A. A. No. I came straight from Purdue after
`
` A. A.
` receiving my Ph.D. into a career first in industry
` at Columbia Research Lab and then in academia.
`
` Q. Q. At Northeastern, do you have a lab? Are
`
` Q. Q.
` you in charge of a research lab?
`
` A. A. Yes, I am.
`
` A. A.
`
` Q. Q. And have you been in charge of a research
`
` Q. Q.
` lab since you joined the university in 1993?
`
` A. A. Yes.
`
` A. A.
`
` Q. Q. In general terms, at this time, what is
`
` Q. Q.
` the focus of the research ongoing in your lab or
` under your direction in your lab?
`
` A. A. So we work on pharmaceutical formulations,
`
` A. A.
`
`
` A. A. So there are approaches where you design
`
` A. A.
` nanoparticles or nanodelivery systems using the
` same technologies of fabrication that's used for
` making computer chips.
`
` Q. Q. What did you mean by "milling processes"?
`
` Q. Q.
`
` A. A. So milling is a process where you reduce
`
` A. A.
` particle size. You start out with either
` large-sized crystal of a drug and then you reduce
` it down to a smaller size.
` In our case, this would be nanoparticles
` that are made using those crystals of drugs, larger
` crystals.
`
` Q. Q. What do you mean by "nanoparticle"?
`
` Q. Q.
`
` A. A. So nanoparticle is basically defined as an
`
` A. A.
` entity that has a dimension of 1 to 1,000
` nanometer.
`
` Q. Q. How long has your research lab been
`
` Q. Q.
` working on ways to make nanoparticles?
`
` A. A. So I started even when I was at Purdue, so
`
` A. A.
` I would say even before I came to Northeastern in
` '93. But since '93, as I've been at Northeast,
` I've been working on nanoformulations now. So it
` would be, I would say, close to about 23 -- yeah,
` 23 years.
`
` Q. Q. Okay. So nanoparticle has always been
`
` Q. Q.
`
`Page 11
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` specifically looking at various ways to enhance the
` delivery of drugs to target sites in the body. We
` work with various formulations that are intended
` for oral, internasal and systemic therapies, and we
` are specifically focused on nanoparticle-based drug
` delivery systems.
`
` Q. Q. Did your lab focus on ways to make
`
` Q. Q.
` nanoparticles?
`
` A. A. Yes.
`
` A. A.
`
` Q. Q. The research lab?
`
` Q. Q.
` THE REPORTER: I'm sorry. I could not
` hear you. Research?
` BY MS. FLANAGAN:
`
` Q. Q. Your research lab.
`
` Q. Q.
`
` A. A. Yes.
`
` A. A.
`
` Q. Q. And -- thank you. What ways is your lab
`
` Q. Q.
` currently researching for how to make
` nanoparticles?
`
` A. A. So we have used a number of methods. We
`
` A. A.
` have worked with nanoprecipitation methods. We
` have also used nanofabrication. We have used
` approaches such as the milling processes. We have
` used a number of different strategies to make
` nanoparticles.
`
` Q. Q. What do you mean by nanofabrication?
`
` Q. Q.
`
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` part of the research that your lab has been focused
` on?
`
` A. A. Yes. In -- you know, we have used a
`
` A. A.
` number of different formulation, again, designing
` for oral or systemic administration.
`
` Q. Q. You're not a medical doctor; correct?
`
` Q. Q.
`
` A. A. No. I am a pharmacist.
`
` A. A.
`
` Q. Q. But you're not -- you don't have an MD
`
` Q. Q.
` degree?
`
` A. A. No. I have a Ph.D., and I'm also an R.Ph.
`
` A. A.
` I am a pharmacist.
`
` Q. Q. But you're not a medical doctor?
`
` Q. Q.
`
` A. A. No, I'm not a medical --
`
` A. A.
`
` Q. Q. You don't have an MD degree?
`
` Q. Q.
`
` A. A. No.
`
` A. A.
`
` Q. Q. And as a registered pharmacist, have you
`
` Q. Q.
` ever prescribed a medication?
`
` A. A. No. I -- certainly, you know, I have
`
` A. A.
` worked on various types of medications from my
` research perspective, as well as I'm familiar with,
` you know, medication-dispensing function, and
` I've -- previously I worked as a pharmacist in
` dispensing, but these days I don't work as a
` pharmacist, but I still maintain my license.
`
` Q. Q. But the answer to my question in terms of
`
` Q. Q.
`
`GregoryEdwards, LLC | Worldwide Court Reporting
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`
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`

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`Mansoor Amiji - December 18, 2015
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` do you prescribe medications, the answer is no?
`
` A. A. Yes. No, I don't prescribe medications.
`
` A. A.
`
` Q. Q. And you never have?
`
` Q. Q.
`
` A. A. That's correct; yes, I've never prescribed
`
` A. A.
` medications.
`
` Q. Q. When did you work as a registered
`
` Q. Q.
` pharmacist?
`
` A. A. It was quite a while ago. I would say
`
` A. A.
` sometime in the early 2000.
`
` Q. Q. And you were actually dispensing
`
` Q. Q.
` medications in that role?
`
` A. A. Yes.
`
` A. A.
`
` Q. Q. Have you ever been involved in writing
`
` Q. Q.
` clinical study protocols for investigating a drug?
`
` A. A. I have reviewed a number of different
`
` A. A.
` clinical protocols for various type of new drug
` applications, as well as abbreviated new drug
` applications.
`
` Q. Q. So you've never been involved in writing
`
` Q. Q.
` those clinical study protocols, though?
`
` A. A. Not writing, but I have been -- I have
`
` A. A.
` certainly reviewed as part of the NDA or ANDA
` submissions.
`
` Q. Q. And in what context have you been
`
` Q. Q.
` reviewing clinical study protocols?
`
`5 (Pages 14 to 17)
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` done.
`
` Q. Q. Your consulting work?
`
` Q. Q.
`
` A. A. Correct.
`
` A. A.
`
` Q. Q. Approximately how many times have you been
`
` Q. Q.
` deposed, Dr. Amiji?
`
` A. A. I would say about six or seven times.
`
` A. A.
`
` Q. Q. Have you testified at trial before?
`
` Q. Q.
`
` A. A. Yes, I have.
`
` A. A.
`
` Q. Q. About how many times?
`
` Q. Q.
`
` A. A. Three times.
`
` A. A.
`
` Q. Q. Have you testified at any hearings in
`
` Q. Q.
` court outside the context of a trial?
`
` A. A. Yes, I have.
`
` A. A.
`
` Q. Q. About how many times?
`
` Q. Q.
`
` A. A. One.
`
` A. A.
`
` Q. Q. Do you recall the context for that
`
` Q. Q.
` hearing?
`
` A. A. Yes.
`
` A. A.
`
` Q. Q. And what was that hearing for?
`
` Q. Q.
`
` A. A. It was an arbitration panel. I was an
`
` A. A.
` expert witness serving on an arbitration panel.
` MS. LEA: And sometimes arbitrations are
` confidential, so I would caution the witness not to
` reveal any confidential information about other
` parties.
`
`Page 15
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`
` A. A. In term -- when I consult for companies
`
` A. A.
` that are interested in developing formulations that
` are going through clinical trials, as well as a
` number of different cases that I've been involved
` as an expert witness.
`
` Q. Q. Have you been involved in writing clinical
`
` Q. Q.
` study reports for drugs?
`
` A. A. No. Again, I have reviewed reports as
`
` A. A.
` well. I have reviewed various reports that have
` come from clinical trials.
`
` Q. Q. Have you ever served as a clinical study
`
` Q. Q.
` investigator?
`
` A. A. No, I have not.
`
` A. A.
`
` Q. Q. The protocols and clinical study reports
`
` Q. Q.
` that you mentioned you reviewed, have any of them
` related to NSAIDs?
`
` A. A. I'm sorry. I didn't get the last part of
`
` A. A.
` your question.
`
` Q. Q. N-S-A-I-D-S, NSAID drugs?
`
` Q. Q.
`
` A. A. Yes. You mean the nonsteroidal
`
` A. A.
` anti-inflammatory drugs. I believe there may be
` some. I don't recall exactly, but I have worked on
` NSAIDs for, you know, both in my research, as well
` as I've also reviewed a number of clinical
` protocols based on some of the work that I have
`
`09:18
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`
` BY MS. FLANAGAN:
`
` Q. Q. When was the last time that you gave
`
` Q. Q.
` testimony under oath, either at a deposition,
` trial, or arbitration?
`
` A. A. In the latter part of November this year.
`
` A. A.
`
` Q. Q. Doctor, did you do anything to prepare for
`
` Q. Q.
` your deposition today?
`
` A. A. Yes. I reviewed my report, my
`
` A. A.
` declaration. I reviewed the patents. I reviewed
` the various exhibits.
`
` Q. Q. When patents did you review?
`
` Q. Q.
`
` A. A. The patents-in-suit.
`
` A. A.
`
` Q. Q. And what do you mean, "the various
`
` Q. Q.
` exhibits"? What -- what does that mean?
`
` A. A. The exhibits that are part of the
`
` A. A.
` declaration that I provided.
`
` Q. Q. So your CV and the materials considered
`
` Q. Q.
` list?
`
` A. A. That's correct.
`
` A. A.
`
` Q. Q. Anything else that you reviewed to prepare
`
` Q. Q.
` for your deposition?
`
` A. A. No. It's -- yeah, those are the documents
`
` A. A.
` that I -- you know, that have been involved. In
` preparing the declaration, I basically reviewed all
` of those documents.
`
`GregoryEdwards, LLC | Worldwide Court Reporting
`GregoryEdwards.com | 866-4Team GE
`
`5
`
`

`
`Mansoor Amiji - December 18, 2015
`
`Page 18
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`
` Q. Q. Okay. Did you meet with counsel to
`
` Q. Q.
` prepare for your deposition?
`
` A. A. Yes.
`
` A. A.
`
` Q. Q. For about how long?
`
` Q. Q.
`
` A. A. About three or four hours.
`
` A. A.
`
` Q. Q. And who was present during that meeting?
`
` Q. Q.
`
` A. A. Both counsels, Mr. Anger and Ms. Lea.
`
` A. A.
`
` Q. Q. And no one besides counsel was present?
`
` Q. Q.
`
` A. A. Yes.
`
` A. A.
`
` Q. Q. Did you speak with anyone else in your
`
` Q. Q.
` preparation session besides counsel?
`
` A. A. No.
`
` A. A.
`
` Q. Q. I'm going to have -- would the court
`
` Q. Q.
` reporter please hand to the witness what we
` premarked as Exhibit 1, and also hand a copy to
` counsel.
` (Miscellaneous comments.)
` BY MS. FLANAGAN:
`
` Q. Q. Dr. Amiji, you've been handed what we have
`
` Q. Q.
` marked as Exhibit 1. Do you recognize the
` document, sir?
`
` A. A. Yes.
`
` A. A.
` (Deposition Exhibit 1 was marked for
` identification by the reporter and is
` attached hereto.)
`
`6 (Pages 18 to 21)
`
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`
` then give my opinion as far as what those claim
` terms would mean to a person skilled in the art.
`
` Q. Q. So if I understand your methodology, you
`
` Q. Q.
` first read the patents, then you were given the
` parties' proposed claim constructions, and then you
` developed your opinions?
` MS. LEA: Objection. Misstates testimony.
`
` A. A. I looked at, you know, the
`
` A. A.
` patents-in-suit. Yes, I was provided with the --
` you know, the different claim terms that were in
` dispute. And I then went on to review the
` specifications, the intrinsic evidence, and then
` provided the opinions that are present in my
` declaration.
` BY MS. FLANAGAN:
`
` Q. Q. Did you write your declaration, sir?
`
` Q. Q.
` MS. LEA: I'm going to object to the
` question. I believe the question is violating the
` Federal Rules of Civil Procedure that provide for
` protection in communications between expert and
` counsel. And I will instruct the expert not to
` answer the question.
` MS. FLANAGAN: Counsel, I disagree that
` Rule 26 prevents questions about the process for
` writing the report, and that's what my question is
`
`Page 21
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` BY MS. FLANAGAN:
`
` Q. Q. What is it?
`
` Q. Q.
`
` A. A. It's a declaration that I provided for the
`
` A. A.
` claim construction brief.
`
` Q. Q. And this includes, as appendices, your CV
`
` Q. Q.
` and also a list of materials considered; correct?
`
` A. A. Yes.
`
` A. A.
`
` Q. Q. And if you can flip to page 26 of the
`
` Q. Q.
` declaration, please, let me know when you are
` there.
`
` A. A. I'm there.
`
` A. A.
`
` Q. Q. Okay. And that's your signature, sir?
`
` Q. Q.
`
` A. A. Yes.
`
` A. A.
`
` Q. Q. And you signed this declaration on
`
` Q. Q.
` December 3rd, 2015?
`
` A. A. Yes.
`
` A. A.
`
` Q. Q. Do you have any corrections that you would
`
` Q. Q.
` like to make to this declaration?
`
` A. A. No. This declaration stands as is.
`
` A. A.
`
` Q. Q. Can you generally describe the process you
`
` Q. Q.
` went through to prepare this declaration?
`
` A. A. So I was consulted by counsel and asked to
`
` A. A.
` review the patents. And then I was provided with
` the claim terms that were in dispute, and I was
` asked to consider the various claim elements and
`
`09:24
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` directed to, not to communications.
` MS. LEA: Okay. Well, then we disagree.
` BY MS. FLANAGAN:
`
` Q. Q. Are you going to follow the instruction
`
` Q. Q.
` not to answer that question?
`
` A. A. Yes.
`
` A. A.
`
` Q. Q. So you're not willing to let me know if
`
` Q. Q.
` you wrote your own declaration?
` MS. LEA: I'm going to object and instruct
` the witness not to answer. They are argumentative
` questions. I am instructing him not to answer your
` questions.
` BY MS. FLANAGAN:
`
` Q. Q. Sir, if you were not instructed not to
`
` Q. Q.
` answer the question, could you answer it?
`
` A. A. It's -- all of the opinions that are in
`
` A. A.
` this declarations are mine.
`
` Q. Q. So you adopt everything that's written in
`
` Q. Q.
` the declaration as your own?
`
` A. A. Correct. All of the opinions that are
`
` A. A.
` stated in the declarations are mine.
`
` Q. Q. Okay. Thank you.
`
` Q. Q.
` Can you please find Appendix 2 to your
` declaration, which is your materials considered list,
` and let me know when you are there?
`
`GregoryEdwards, LLC | Worldwide Court Reporting
`GregoryEdwards.com | 866-4Team GE
`
`6
`
`

`
`Mansoor Amiji - December 18, 2015
`
`Page 22
`
`7 (Pages 22 to 25)
`
`Page 24
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`
` "excipient particle size."
` BY MS. FLANAGAN:
`
` Q. Q. So I -- in fact, I can clarify. Have you
`
` Q. Q.
` measured a particle size of any component? I don't
` want to limit my question to just an active drug,
` but any component of the pharmaceutical
` formulation.
`
` A. A. Yeah, I measured particle size of, you
`
` A. A.
` know, different products that are formed. So
` nanoparticles, for example, would be formed by
` encapsulating a drug. And so I formed -- I
` measured the particle size of the form nanoparticle
` that had both the drug and the excipients.
`
` Q. Q. And you, yourself, have done the
`
` Q. Q.
` particle-size measurements?
`
` A. A. On certain occasions, and then on some
`
` A. A.
` occasions I have reviewed the data that my students
` and postdocs have collected, and we have discussed
` that together.
`
` Q. Q. Have you done or supervised particle-size
`
` Q. Q.
` testing done following a wet-milling technique?
`
` A. A. Yes.
`
` A. A.
`
` Q. Q. And have you, yourself, done that?
`
` Q. Q.
`
` A. A. I have reviewed the data after the product
`
` A. A.
` was wet-milled.
`
`09:25
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`
` A. A. I'm there.
`
` A. A.
`
` Q. Q. What does this list, which is identified
`
` Q. Q.
` as Appendix 2, reflect?
`
` A. A. So these are the different materials that
`
` A. A.
` I had reviewed when I was preparing the
` declaration.
`
` Q. Q. Were you given all the materials by
`
` Q. Q.
` counsel?
` MS. LEA: I'm going to object to any kind
` of question regarding the preparation of his report
` or the exchange of communication between counsel
` and the witness, and instruct the witness not to
` answer.
` BY MS. FLANAGAN:
`
` Q. Q. Are you going to follow that instruction?
`
` Q. Q.
`
` A. A. Yes.
`
` A. A.
`
` Q. Q. Did you independently identify any of
`
` Q. Q.
` those sources on this list?
` MS. LEA: Same objection to the same
` question asked in a different way, and instruct the
` witness not to answer.
` BY MS. FLANAGAN:
`
` Q. Q. So, Dr. Amiji, the file histories that you
`
` Q. Q.
` considered in rendering your opinions in the
` declaration are all listed on Appendix 2; correct?
`
`Page 23
`
`
` A. A. Yes.
`
` A. A.
`
` Q. Q. And all of the patents that you considered
`
` Q. Q.
` in rendering your opinion are listed in Appendix 2;
` correct?
`
` A. A. Yes.
`
` A. A.
`
` Q. Q. I want to learn a little bit more about
`
` Q. Q.
` your experience with milling, so I'm going to go --
` switch subjects. Okay?
`
` A. A. Sure.
`
` A. A.
`
` Q. Q. Have you, you personally, or people
`
` Q. Q.
` working under your direction, wet-milled any drugs?
`
` A. A. Yes.
`
` A. A.
`
` Q. Q. Have you, yourself, have you performed
`
` Q. Q.
` wet-milling techniques on drugs?
`
` A. A. No. I have supervised students of mine
`
` A. A.
` who have done wet milling -- who have done milling
` and have done milling. And then, also, I have
` supervised students who have made nanoparticles
` using other methods.
`
` Q. Q. Have you, yourself, measured an excipient
`
` Q. Q.
` particle size?
` THE REPORTER: I'm sorry. What particle
` size?
` MS. FLANAGAN: An excipient.
`
` A. A. Yeah, I'm not sure what you mean
`
` A. A.
`
`09:27
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`
` Q. Q. And have you done that when the product
`
` Q. Q.
` being wet-milled is a drug?
`
` A. A. Yes.
`
` A. A.
`
` Q. Q. Do you recall which drugs?
`
` Q. Q.
`
` A. A. We work a lot with cancer drugs, so some
`
` A. A.
` of these examples are cancer drugs that were
` wet-milled to reduce