Confidential - Subject to The Protective Order
`Adam C. Myers, Ph.D. - February 24, 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 . , )
`
`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 , ) C a s e N o .
`
` 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 . , )
`
`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 A P T I O N C O N T I N U E D * * * )
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`_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ )
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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 A D A M C . M Y E R S , P h . D .
`
` W e d n e s d a y , F e b r u a r y 2 4 , 2 0 1 6
`
` W a s h i n g t o n , D C
`
`GregoryEdwards, LLC | Worldwide Court Reporting
`GregoryEdwards.com | 866-4Team GE
`
`

`
`Confidential - Subject to The Protective Order
`Adam C. Myers, Ph.D. - February 24, 2016
`
`Page 2
`
`2 (Pages 2 to 5)
`
`Page 4
`
` A P P E A R A N C E S
`
`For the InnoPharma Petitioner and Defendants:
`ALSTON & BIRD LLP
` 333 South Hope Street
` Sixteenth Floor
` Los Angeles, CA 90071
` 213.576.1000
`BY: H. JAMES ABE, ESQ.
` james.abe@alston.com
`
`For the Patent Owner and Plaintiffs:
`FINNEGAN HENDERSON FARABOW
`GARRETT & DUNNER, LLP
` 901 New York Avenue NW
` Washington, DC 20001
` 202.408.4000
`BY: ESTHER H. LIM, ESQ.
` esther.lim@finnegan.com
`BY: CHIAKI FUJIWARA, ESQ.
` Chiaka.fujiwara@finnegan.com
`
` A P P E A R A N C E S (Continued)
`
`Page 5
`
`For the Lupin Defendants:
`GOODWIN PROCTER LLP
` The New York Times Building
` 620 Eighth Avenue
` New York, NY 10018
` 212.813.8800
`BY: NATASHA E. DAUGHTREY, ESQ. (By Telephone)
` ndaughtrey@goodwinprocter.com
`
`Also Present:
` T.J. O'Toole, Videographer
`
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` IN THE UNITED STATES DISTRICT COURT
` FOR THE DISTRICT OF NEW JERSEY
`
`________________________________
` )
`SENJU PHARMACEUTICAL CO., LTD., )
`BAUSCH & LOMB INCORPORATED, and )
`BAUSCH & LOMB PHARMA HOLDINGS ) C.A. Nos.
`CORP., ) 1:14-cv-00667
` ) 1:14-cv-04149
` Plaintiffs, ) 1:14-cv-05144
` )
` vs. )
` )
`LUPIN LIMITED and LUPIN )
`PHARMACEUTICALS, INC., )
` )
` Defendants. )
` )
` vs. )
` )
`INNOPHARMA LICENSING, INC., ) C.A. Nos.
`INNOPHARMA LICENSING, LLC, ) 1:14-cv-06893
`INNOPHARMA, INC., and ) 1:15-cv-03240
`INNOPHARMA, LLC, )
` )
` Defendants. )
` )
`________________________________)
`
` CONFIDENTIAL SUBJECT TO THE PROTECTIVE ORDER
`
` VIDEOTAPED DEPOSITION OF ADAM C. MYERS, Ph.D.
` Wednesday, February 24, 2016
` Washington, DC
`
` Wednesday, February 24, 2016
` 9:06 a.m.
`
`Page 3
`
`VIDEOTAPED DEPOSITION OF ADAM C. MYERS, Ph.D., 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.
`
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`GregoryEdwards, LLC | Worldwide Court Reporting
`GregoryEdwards.com | 866-4Team GE
`
`Page 2
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`

`
`Confidential - Subject to The Protective Order
`Adam C. Myers, Ph.D. - February 24, 2016
`
`Page 6
`
`3 (Pages 6 to 9)
`
`Page 8
`
`1 I N D E X
`
`1 E X H I B I T S (Continued)
`
`EXHIBIT DESCRIPTION PAGE
`
`2 3
`
` EXAMINATION OF ADAM C. MYERS, Ph.D. PAGE
`
`2 3
`
`4 IPR PROCEEDING:
`
`4 Exhibit No. 12 Bausch & Lomb Incorporated Chemical 192
`
`5 By Mr. Abe 12
`
`5 Specification Hidden River,
`
` DISTRICT COURT PROCEEDING:
`
`7 Bromfenac in Bromfenac Ophthalmic
`
`6 HPLC Assay for the Analysis of
`
`6 7
`
`8 By Mr. Abe 141
`
`8 Solutions, PROL0003907 to 928
`
`9 By Ms. Lim 228
`
`9 Exhibit No. 13 Reply Expert Report of Adam C. Myers, 195
`
`10 -o0o-
`
`10 Ph.D., Senju v. InnoPharma,
`
`11
`
`11 District Court
`
`12 E X H I B I T S
`
`12 Exhibit No. 14 Reply Expert Report of Adam C. Myers, 199
`
`13
`
`13 Ph.D., Senju v. Lupin, District Court
`
`14 EXHIBIT DESCRIPTION PAGE
`
`14 -o0o-
`
`Page 9
`
` P R O C E E D I N G S
` - - -
` THE VIDEOGRAPHER: On the record
`with disk No. 1 of the video deposition of Dr. Adam
`Myers taken in the matter of InnoPharma Licensing
`Incorporated, et al. versus Senju Pharmaceutical
`Company, Limited, et al., being heard before the
`Patent Trial and Appeal Court of the United States
`Patent and Trademark Office, Case No. IPR2015-00902,
`and the related matter Senju Pharmaceutical Company,
`Limited, et al. versus Lupin Limited, et al., being
`heard before the United States District Court for
`the District of New Jersey, Civil Action No.
`1:14-CV-00667-JBS-KMW.
` This deposition is being held at
`the law offices of Finnegan Henderson located at 901
`New York Avenue, Northwest in Washington, DC on
`February 24, 2016 at approximately 9:06 a.m.
` My name is T.J. O'Toole. I am the
`certified legal specialist. The court reporter is
`Denise Vickery. We are both here representing
`Gregory Edwards, LLC.
`
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`15 Exhibit No. 1 United States Patent No. 8,669,290 20
`
`16 Sawa et al., InnoPharma EX1001
`
`17 Exhibit No. 2 Declaration of Adam C. Myers, Ph.D. 24
`
`18 Senju Exhibit 2126
`
`19 Exhibit No. 3 European Pharmacopoeia, Volume I 35
`
`20 LUPIN068837 to 854
`
`21 Exhibit No. 4 Supplemental Expert Report of Adam C. 103
`
`22 Myers, Ph.D., Senju Exhibit 2256
`
`Page 7
`
`1 E X H I B I T S (Continued)
`
`EXHIBIT DESCRIPTION PAGE
`
`2 3
`
`4 Exhibit No. 5 SSCI Chromatographic Data from the 135
`
`5 Stability Evaluation of Bromfenac Sodium
`
`6 Drug Product Samples for Potency
`
`7 PROL0337648 to 700, Senju Exhibit 2248
`
`8 Exhibit No. 6 Lab Notebook PROL0337631 to 639 137
`
`9 Senju Exhibit 2247
`
`10 Exhibit No. 7 Expert Report of Adam C. Myers, Ph.D. 140
`
`11 Senju v. Lupin, District Court
`
`12 Exhibit No. 8 Expert Report of Adam C. Myers, Ph.D. 147
`
`13 Senju v. InnoPharma, District Court case
`
`14 Exhibit No. 9 Supplemental Expert Report of Adam C. 151
`
`15 Myers, Ph.D., Senju v. InnoPharma,
`
`16 District Court
`
`17 Exhibit No. 10 Supplemental Expert Report of Adam C. 156
`
`18 Myers, Ph.D., Senju v. Lupin, District
`
`19 Court
`
`20 Exhibit No. 11 Translated Data Studies 157
`
`21 PROL0336772 to 7120
`
`22 ///
`
`GregoryEdwards, LLC | Worldwide Court Reporting
`GregoryEdwards.com | 866-4Team GE
`
`Page 3
`
`

`
`Confidential - Subject to The Protective Order
`Adam C. Myers, Ph.D. - February 24, 2016
`
`Page 10
`
` Will counsel please introduce
`themselves and indicate which parties they
`represent.
` MR. ABE: James Abe of Alston &
`Bird for the InnoPharma Defendants and Petitioner
`InnoPharma.
` MS. LIM: Esther Lim and Chiaki
`Fujiwara with Finnegan on behalf of Plaintiffs.
` THE VIDEOGRAPHER: Thank you.
`Will the court reporter please swear in the witness.
` - - -
` ADAM C. MYERS, Ph.D.
`called for examination, and, after having been duly
`sworn, was examined and testified as follows:
` MR. ABE: Can we go off the record
`for a second? I don't think my realtime is working.
` THE VIDEOGRAPHER: The time is
`9:07:36. Off the record.
` (Recess - 9:07 a.m. - 9:11 a.m.)
` THE VIDEOGRAPHER: On the record.
`The time is 9:11:33.
` MR. ABE: Okay. I'll just note
`
`Page 11
`
`for the record, this is the consolidated proceeding
`for the IPR2015-00902 and the district --
`corresponding District Court proceedings involving
`the same parties, also Lupin, and that it's being
`taken pursuant to an agreement that was reached
`between the parties.
` And I will start with the IPR
`portion and I'll note when we'll switch over to the
`District Court portion, but it's under the
`understanding that the parties will not object to
`having the IPR proceeding portion of your testimony
`being used for the District Court proceeding.
` MS. LIM: Counsel, I'd like to
`clarify for the record --
` MR. ABE: Sure.
` MS. LIM: -- that that
`understanding is memorialized in the e-mail
`correspondence between the parties, and that there
`is a caveat for satisfying the other rules of the
`Federal Rules of Civil Procedure and Federal Rules
`of Evidence. So subject to that clarification, we
`can proceed.
`
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`4 (Pages 10 to 13)
`
`Page 12
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` MR. ABE: Yes, it's as
`memorialized in the e-mails you referenced. That's
`correct.
` CROSS-EXAMINATION
`BY MR. ABE:
`
` Q. Q. Okay. Will you state your name for the
`
` Q. Q.
`record?
`
` A. A. Adam Myers.
`
` A. A.
`
` Q. Q. Okay. Dr. Myers, have you been deposed
`
` Q. Q.
`before?
`
` A. A. No, I have not.
`
` A. A.
`
` Q. Q. Okay. I'll go over some of the basic
`
` Q. Q.
`rules.
` I represent the InnoPharma entities in
`this case. I'll be asking questions from you and
`I'll expect answers. Your counsel might object, but
`unless your counsel instructs you not to answer,
`I'll expect an answer.
`
` A. A. (Nods head).
`
` A. A.
`
` Q. Q. You understand you're under oath to
`
` Q. Q.
`testify as if you're in a court proceeding and in
`court.
`
`Page 13
`
` What else?
` If I ask you a question and you don't
`understand or if it's unclear, just let me know.
`I'll try to clarify. But if you answer my question,
`I'll assume you understood it.
`
` A. A. (Nods head).
`
` A. A.
`
` Q. Q. And also avoid talking over each other
`
` Q. Q.
`so that the court reporter can take a cleaner
`record, and please respond verbally. No nodding or
`uh-huhs, which are difficult to show on the record.
`
` A. A. (Nods head).
`
` A. A.
`
` Q. Q. And oh, yeah. If you need a break,
`
` Q. Q.
`just let me know. But if I have a question pending,
`I'll expect you to answer it before we go on the
`break.
` Is there any reason why you cannot
`testify truthfully today?
`
` A. A. No, there's no reason.
`
` A. A.
`
` Q. Q. You're not taking any medication that
`
` Q. Q.
`might impact your ability to testify accurately?
`
` A. A. No, I am not.
`
` A. A.
`
` Q. Q. Okay. And you mentioned earlier you
`
` Q. Q.
`
`GregoryEdwards, LLC | Worldwide Court Reporting
`GregoryEdwards.com | 866-4Team GE
`
`Page 4
`
`

`
`Confidential - Subject to The Protective Order
`Adam C. Myers, Ph.D. - February 24, 2016
`
`Page 14
`
`never testified -- never been deposed before?
`
` A. A. That is correct.
`
` A. A.
`
` Q. Q. So you never acted as an expert witness
`
` Q. Q.
`in any -- ever in any previous matter?
`
` A. A. No, I have not.
`
` A. A.
`
` Q. Q. Okay. Who is your current employer?
`
` Q. Q.
`
` A. A. I'm employed by SSCI, a division of
`
` A. A.
`Albany Molecular Research.
`
` Q. Q. Okay. And what is the nature of your
`
` Q. Q.
`company's business?
`
` A. A. We're a contract research company
`
` A. A.
`working with the pharmaceutical industry primarily.
`
` Q. Q. By "contract research," what kind of
`
` Q. Q.
`contract research is provided by SSCI?
`
` A. A. We perform a variety of analytical
`
` A. A.
`tests as well as chemical development support, both
`in a GMP and non-GMP fashion, supporting a variety
`of industries, primarily the pharmaceutical
`industry.
`
` Q. Q. When you mentioned "GMP," that refers
`
` Q. Q.
`to Good Manufacturing Practice; is that correct?
`
` A. A. That is correct.
`
` A. A.
`
`Page 15
`
`
` Q. Q. What's your understanding of GMP?
`
` Q. Q.
`
` A. A. GMP is a set of federal regulations
`
` A. A.
`codified by the Code of Federal Regulations which
`requires certain controls to be in place for
`assuring quality of a drug product or drug
`substance.
`
` Q. Q. Can you expand a little bit? What do
`
` Q. Q.
`you mean by "controls"?
`
` A. A. Controls would include items such as
`
` A. A.
`instrument calibrations, facility controls such as
`pest control, quality reviews, data integrity and
`proper data storage.
`
` Q. Q. And SSCI provides support in GMP and
`
` Q. Q.
`non-GMP fashion; is that right?
`
` A. A. That is correct.
`
` A. A.
`
` Q. Q. When does it provide support in GMP
`
` Q. Q.
`fashion?
`
` A. A. So our facility as a whole is run as a
`
` A. A.
`GMP facility. So our facility controls are GMP at
`all times. We perform testing on a GMP basis as
`requested by clients.
`
` Q. Q. And for non-GMP, when would that apply?
`
` Q. Q.
`
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`5 (Pages 14 to 17)
`
`Page 16
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` A. A. This would be when requested by
`
` A. A.
`clients. That uses the same instrumentation that
`would be used for GMP.
`
` Q. Q. When you said non-GMP would use the
`
` Q. Q.
`same instrumentation as GMP uses, so I'm a little
`unclear.
` What's the difference again?
`
` A. A. The difference is primarily in the data
`
` A. A.
`review side from our quality assurance department.
`
` Q. Q. Is SSCI asked to conduct testing that
`
` Q. Q.
`is submitted to regulatory authorities, such as the
`FDA?
`
` A. A. Yes.
`
` A. A.
`
` Q. Q. And for those types of requests, I
`
` Q. Q.
`assume it would be for GMP-type services?
` Or let me rephrase that.
` For testing that would be submitted to
`a regulatory authority like the FDA, those services
`that are provided would be in compliance with the
`GMP requirements?
`
` A. A. That is correct.
`
` A. A.
`
` Q. Q. Dr. Myers, I understand you're
`
` Q. Q.
`
`Page 17
`
`testifying regarding some testing data that was
`submitted in this case; is that right?
`
` A. A. That is correct.
`
` A. A.
`
` Q. Q. You understand it's not -- is it your
`
` Q. Q.
`understanding that -- strike that.
` It's your understanding that the
`testing data that you've submitted in this case are
`not being submitted to a regulatory authority; is
`that right?
`
` A. A. That is correct.
`
` A. A.
`
` Q. Q. You understand it's being submitted
`
` Q. Q.
`pursuant to a lawsuit between parties regarding a
`patent dispute; is that right?
`
` A. A. Yes.
`
` A. A.
` MS. LIM: I'd just like to
`clarify. You are still referring to the Patent
`Office proceeding with this witness?
` MR. ABE: For this portion, that
`would be fine. Yeah.
` MS. LIM: Yes.
`BY MR. ABE:
`
` Q. Q. For testing that is generated for such
`
` Q. Q.
`
`GregoryEdwards, LLC | Worldwide Court Reporting
`GregoryEdwards.com | 866-4Team GE
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`Page 5
`
`

`
`Confidential - Subject to The Protective Order
`Adam C. Myers, Ph.D. - February 24, 2016
`
`Page 18
`
`patent disputes, that wouldn't have to be in
`compliance with GMP; correct?
` MS. LIM: Objection to the extent
`it calls for a legal conclusion.
` THE WITNESS: Testing that we
`would conduct would vary based on the particular
`project.
`BY MR. ABE:
`
` Q. Q. I understand. My question was a little
`
` Q. Q.
`different.
` The testing that was conducted in this
`case, that wouldn't have to be required -- start
`over.
` The testing that was conducted in this
`case wouldn't have to be in compliance with GMP;
`right?
` MS. LIM: Objection. Calls for
`legal conclusion. Vague.
` THE WITNESS: The testing
`performed in this case did not have a quality
`assurance review for confidentiality purposes. So,
`therefore, because there's no QA review, it would
`
`Page 19
`
`not be classified as GMP release data.
`BY MR. ABE:
`
` Q. Q. How much of the testing that is
`
` Q. Q.
`conducted at SSCI is for ophthalmic products?
`
` A. A. I'm not sure on that.
`
` A. A.
`
` Q. Q. Okay. So how about you personally?
`
` Q. Q.
`How frequently are you required to take part in
`testing of ophthalmic products?
`
` A. A. Most of the testing that we perform is
`
` A. A.
`on -- we perform a lot of testing on API. So it can
`go into a variety of products. Sometimes it is not
`yet specified the final use. So it's hard for me to
`estimate what that would be.
`
` Q. Q. And just for the record, "API," you're
`
` Q. Q.
`referring to active pharmaceutical ingredient; is
`that right?
`
` A. A. That is correct.
`
` A. A.
`
` Q. Q. The testing that SSCI conducts, is it
`
` Q. Q.
`predominantly for what is known as the innovator's
`side of the drug manufacturing companies, or would
`it be the generic companies? Do you know?
` MS. LIM: Objection. Vague.
`
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`6 (Pages 18 to 21)
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`Page 20
`
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`Foundation.
` THE WITNESS: I can't say
`specifically our clients. We perform testing for a
`variety of firms.
` MR. ABE: Okay. So I hand to you
`the first Exhibit 1.
` (Document marked, for
`identification purposes, as Myers Exhibit No. 1.)
`BY MR. ABE:
`
` Q. Q. So that will be Paulson Exhibit -- I'm
`
` Q. Q.
`sorry -- Myers Exhibit 1. For the record was -- is
`the Exhibit EX1001 in IPR2015-00902, and this is the
`United States patent 8,669,290.
` Doctor, is it okay if I refer to this
`as the '290 patent?
`
` A. A. That is fine.
`
` A. A.
`
` Q. Q. Okay. Have you seen this patent
`
` Q. Q.
`before?
`
` A. A. (Reviewing document). Yes, I have.
`
` A. A.
`
` Q. Q. Okay. Dr. Myers, I understand that
`
` Q. Q.
`SSCI performs some potency testing of the bromfenac
`product; is that correct?
`
`Page 21
`
`
` A. A. Yes, that is correct.
`
` A. A.
`
` Q. Q. And there was also preservative
`
` Q. Q.
`efficacy testing involved for the bromfenac product.
`Do you understand that?
`
` A. A. Yes.
`
` A. A.
`
` Q. Q. And you're aware that the preservative
`
` Q. Q.
`efficacy testing was conducted by a company by the
`name of, I believe, BioScience Laboratory, Inc.; is
`that right?
`
` A. A. That is correct.
`
` A. A.
`
` Q. Q. Okay. Is it okay if I refer to
`
` Q. Q.
`BioScience Laboratory as BSL?
`
` A. A. That will be fine.
`
` A. A.
`
` Q. Q. Okay. Did SSECI -- strike that. I
`
` Q. Q.
`think I misspoke.
` Did SSCI provide instructions to BSL on
`how to conduct the preservative efficacy testing?
`
` A. A. Yes.
`
` A. A.
`
` Q. Q. And SSCI instructed BSL to conduct the
`
` Q. Q.
`preservative efficacy testing in accordance with the
`'290 patent; is that right?
`
` A. A. I would need to look at the specific
`
` A. A.
`
`GregoryEdwards, LLC | Worldwide Court Reporting
`GregoryEdwards.com | 866-4Team GE
`
`Page 6
`
`

`
`Confidential - Subject to The Protective Order
`Adam C. Myers, Ph.D. - February 24, 2016
`
`Page 22
`
`conditions in the patent to determine that and to
`refer back to my specific correspondence with them.
`
` Q. Q. Well, let's take a look at Exhibit 1,
`
` Q. Q.
`the '290 patent.
`
` A. A. Yes.
`
` A. A.
`
` Q. Q. I will direct your attention to
`
` Q. Q.
`column 9.
`
` A. A. Yes.
`
` A. A.
`
` Q. Q. And from around row 54 continuing on
`
` Q. Q.
`through column 10 row 48, it describes an EP
`criteria A and EP criteria B.
` Do you see that?
`
` A. A. Yes, I do.
`
` A. A.
`
` Q. Q. Does this refresh your recollection of
`
` Q. Q.
`the instructions that was provided to BSL to conduct
`the preservative efficacy testing?
`
` A. A. It doesn't refresh a recollection, but
`
` A. A.
`I do see the criteria.
`
` Q. Q. Is it your understanding that the
`
` Q. Q.
`preservative efficacy testing was conducted in
`accordance with what is described in the '290
`patent?
`
`7 (Pages 22 to 25)
`
`Page 24
`
`1 instructed BSL to use a particular version of the
`2 European Pharmacopoeia to conduct the preservative
`3 efficacy testing, would you?
`4
`
` A. A. I would have to look back at
`
` A. A.
`5 correspondence with BSL to say with certainty.
`6 MR. ABE: Okay. Let's mark as
`7 Exhibit 2.
`8 (Document marked, for
`9 identification purposes, as Myers Exhibit No. 2.)
`10 BY MR. ABE:
`11
`
` Q. Q. Okay. Myers Exhibit 2 is the
`
` Q. Q.
`12 Declaration of Adam C. Myers, Ph.D. in the IPR
`13 proceeding, Exhibit 2126.
`14 Doctor, is this your declaration?
`15
`
` A. A. (Reviewing document). Yes, it is.
`
` A. A.
`16
`
` Q. Q. So on page 5 of Exhibit 2, that's your
`
` Q. Q.
`17 signature where it's dated December 22, 2015?
`18
`
` A. A. That is correct.
`
` A. A.
`19
`
` Q. Q. And this declaration states your
`
` Q. Q.
`20 complete opinions in the IPR proceeding; is that
`21 right?
`22
`
` A. A. Yes.
`
` A. A.
`
`Page 23
`
`Page 25
`
` MS. LIM: Objection. Vague.
` THE WITNESS: Could you please
`clarify which criteria you're speaking of?
`BY MR. ABE:
`
` Q. Q. Let's start with criteria A then.
`
` Q. Q.
` Is it your understanding that BSL
`conducted their preservative efficacy testing in
`accordance of what the '290 patent describes as EP
`criteria A; is that right?
` MS. LIM: Objection. Vague.
`Calls for legal conclusion.
` THE WITNESS: Off the top of my
`head right now, I don't remember the specific
`criteria that we requested for them to do.
`BY MR. ABE:
`
` Q. Q. Okay. And if I asked you the same
`
` Q. Q.
`question for EP criteria B, your answer would be the
`same; is that right?
`
` A. A. That would be correct.
`
` A. A.
`
` Q. Q. Okay. So you wouldn't be aware of
`
` Q. Q.
`which version of the EP criteria -- strike that.
` And you wouldn't know if SSCI
`
`1
`
` Q. Q. Did anyone assist you in reaching this
`
` Q. Q.
`2 opinion?
`3
`
` A. A. No.
`
` A. A.
`4
`
` Q. Q. Are you aware of any corrections that
`
` Q. Q.
`5 need to be made in your declaration?
`6
`
` A. A. (Reviewing document).
`
` A. A.
`7 The footer date in my appendix report
`8 lists as 12/18. It did not automatically update
`9 with the cover date of 12/24 on the Appendix A.
`10
`
` Q. Q. Thank you.
`
` Q. Q.
`11 And, Doctor, you reviewed your
`12 declaration prior to signing it; correct?
`13
`
` A. A. That is correct.
`
` A. A.
`14
`
` Q. Q. And you reviewed the testing that was
`
` Q. Q.
`15 reported in Appendix A prior to signing your
`16 declaration?
`17
`
` A. A. (Reviewing document). Yes.
`
` A. A.
`18
`
` Q. Q. One second.
`
` Q. Q.
`19 You are aware that your signature is
`20 dated on November 22nd -- sorry -- December 22nd,
`21 yet you just told me the report is dated
`22 December 24, 2015; is that right?
`
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`GregoryEdwards, LLC | Worldwide Court Reporting
`GregoryEdwards.com | 866-4Team GE
`
`Page 7
`
`

`
`Confidential - Subject to The Protective Order
`Adam C. Myers, Ph.D. - February 24, 2016
`
`Page 26
`
`
` A. A. That is correct.
`
` A. A.
`
` Q. Q. Let's look at Appendix A of your
`
` Q. Q.
`declaration, which is Exhibit 2. Paulson Exhibit 2
`I should say.
`
` A. A. Could you please clarify the exhibit?
`
` A. A.
`I believe you --
`
` Q. Q. Sorry. This is Paulson Exhibit 2 is
`
` Q. Q.
`your declaration --
`
` A. A. All right.
`
` A. A.
`
` Q. Q. -- and accompanying appendix.
`
` Q. Q.
`
` A. A. I have Myers Exhibit 2.
`
` A. A.
`
` Q. Q. Yes. Oh, my apologies.
`
` Q. Q.
`
` A. A. Thank you.
`
` A. A.
`
` Q. Q. (Laugh). Let me start over.
`
` Q. Q.
` Myers Exhibit 2, Appendix A. Are you
`there? Yes?
`
` A. A. Yes.
`
` A. A.
`
` Q. Q. Okay. If you turn to page 3 of the
`
` Q. Q.
`appendix where it says "Summary."
`
` A. A. Yes.
`
` A. A.
`
` Q. Q. The first sentence says:
`
` Q. Q.
` "Bromfenac sodium ophthalmic solution
`
`Page 27
`
`drug products were sourced from Senju."
` You see that?
`
` A. A. Yes.
`
` A. A.
`
` Q. Q. So you provided testing of a bromfenac
`
` Q. Q.
`product that was provided by Senju; is that right?
`
` A. A. Yes.
`
` A. A.
`
` Q. Q. Is it okay if I refer to the bromfenac
`
` Q. Q.
`product from Senju as the Prolensa product?
`
` A. A. Yes, that would be fine.
`
` A. A.
`
` Q. Q. Okay. Now, this -- is it okay if I
`
` Q. Q.
`refer to Appendix A of your declaration as the SSCI
`report?
`
` A. A. That would be fine.
`
` A. A.
`
` Q. Q. Okay. In your SSCI report, this
`
` Q. Q.
`provides results for both potency testing and also
`preservative efficacy testing; is that right?
`
` A. A. That is correct.
`
` A. A.
`
` Q. Q. And you prepared this report?
`
` Q. Q.
`
` A. A. Yes.
`
` A. A.
`
` Q. Q. Are there any errors that need to be
`
` Q. Q.
`corrected here, other than the date at the footnote?
`
` A. A. (Reviewing document).
`
` A. A.
`
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`8 (Pages 26 to 29)
`
`Page 28
`
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`
` I'm not aware of any other errors.
`
` Q. Q. Okay. Thank you.
`
` Q. Q.
` Now, there is HPLC testing conducted in
`relation to the testing for the potency; right?
`
` A. A. That is correct.
`
` A. A.
`
` Q. Q. Okay. And you personally conducted the
`
` Q. Q.
`HPLC testing?
`
` A. A. I conducted the testing in coordination
`
` A. A.
`with one of my laboratory scientists.
`
` Q. Q. Okay. Who would be that laboratory
`
` Q. Q.
`scientist?
`
` A. A. That was Greg Thomas.
`
` A. A.
`
` Q. Q. And is that his official title at SSCI,
`
` Q. Q.
`laboratory scientist?
`
` A. A. His title is scientist.
`
` A. A.
`
` Q. Q. Okay. How long has Mr. Thomas worked
`
` Q. Q.
`at SSCI? Approximately is fine.
`
` A. A. I would have to give an approximate
`
` A. A.
`time. He has worked there greater than 10 years.
`
` Q. Q. And he's held this position or a
`
` Q. Q.
`similar position for that 10 years; is that right?
`
` A. A. That is correct.
`
` A. A.
`
`Page 29
`
`
` Q. Q. Okay. Why don't we look at the test
`
` Q. Q.
`results reported on page 9. And I apologize. It's
`a little confusing because there's numerous page
`numbers on here, but I was referring to page 9 of 13
`of the appendix, which corresponds to page 15 of 19
`of Myers Exhibit 2, which is EX2126.
` Do you see that?
`
` A. A. Yes, I do.
`
` A. A.
`
` Q. Q. Okay. This is the preservative
`
` Q. Q.
`efficacy testing results; is that right?
`
` A. A. This is one page of them, yes.
`
` A. A.
`
` Q. Q. Okay. Were the results on this page --
`
` Q. Q.
`strike that.
` Did you prepare this portion of the
`report as well?
`
` A. A. I pasted in the report from the BSL
`
` A. A.
`into this page.
`
` Q. Q. So you did not provide the calculation
`
` Q. Q.
`that is shown here?
`
` A. A. No, I did not.
`
` A. A.
`
` Q. Q. It's my understanding you did conduct
`
` Q. Q.
`the HPLC testing which is in relation to the potency
`
`GregoryEdwards, LLC | Worldwide Court Reporting
`GregoryEdwards.com | 866-4Team GE
`
`Page 8
`
`

`
`Confidential - Subject to The Protective Order
`Adam C. Myers, Ph.D. - February 24, 2016
`
`Page 30
`
`testing; right?
`
` A. A. That is correct.
`
` A. A.
`
` Q. Q. Are you providing any opinions as to
`
` Q.