Transcript of Gojko Lalic, Ph.D.
`
`Date: April 12, 2016
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`Case: Altaire Pharmaceuticals, Inc. -v- Paragon Bioteck, Inc. (PTAB)
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`Planet Depos, LLC
`Phone: 888-433-3767
`Fax: 888-503-3767
`Email: transcripts@planetdepos.com
`Internet: www.planetdepos.com
`
`Worldwide Court Reporting | Interpretation | Trial Services
`
`Exhibit 1026, Page 1 of 79
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`
`
`Date: April 12, 2016
`
`Case: Altaire Pharmaceuticals, Inc. -v- Paragon Bioteck, Inc. (PTAB)
`
`Planet Depos, LLC
`Phone: 888-433-3767
`Fax: 888-503-3767
`Email: transcripts@planetdepos.com
`Internet: www.planetdepos.com
`
`Worldwide Court Reporting | Interpretation | Trial Services
`
`Exhibit 1026, Page 1 of 79
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`
`
` UNITED STATES PATENT AND TRADEMARK OFFICE
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` BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`1
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` - - - - - - - - - - - - - -x
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`ALTAIRE PHARMACEUTICALS, :
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`INC. :
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` Petitioner, : Case PGR2015-00011
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` v. : Patent 8,859,623 B1
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`PARAGON BIOTECK, INC., :
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` Patent Owner.
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` - - - - - - - - - - - - - -x
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` Videotape Deposition of Gojko Lalic, Ph.D.
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` Seattle, Washington
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` Tuesday, April 12, 2016
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` 9:00 a.m.
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` Job No.: 108297
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` Pages: 1 - 64
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` Reported By: Diane Rugh, CCR No. 2399, CRR
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`Exhibit 1026, Page 2 of 79
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`
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`Videotaped Deposition of Gojko Lalic, Ph.D.
`Conducted on April 12, 2016
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` Videotape Deposition of GOJKO LALIC, Ph.D.,
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` held at the offices of:
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`2
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` WILSON SONSINI GOODRICH & ROSATI
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` 701 Fifth Avenue, Suite 5100
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` Seattle, Washington 98104-7036
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` 206.883.2500
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` Pursuant to notice, before Diane Rugh, CCR No.
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` 2399, CRR.
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`PLANET DEPOS
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`Exhibit 1026, Page 3 of 79
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`
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`Videotaped Deposition of Gojko Lalic, Ph.D.
`Conducted on April 12, 2016
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` A P P E A R A N C E S
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` ON BEHALF OF PETITIONER:
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` DIPU A. DOSHI, ESQUIRE
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` JONATHAN W.S. ENGLAND, ESQUIRE
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` BLANK ROME LLP
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` 1825 Eye Street NW
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` Washington, DC 20006-5403
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` 202.420.2201
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` ON BEHALF OF PATENT OWNERS:
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` ANDREW BROWN, ESQUIRE
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` SONJA GERRARD, ESQUIRE
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` WILSON SONSINI GOODRICH & ROSATI
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` 701 Fifth Avenue, Suite 5100
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` Seattle, Washington 98104-7036
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` 206.883.2500
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` ALSO PRESENT:
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` Michael Takos, Videographer
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`PLANET DEPOS
`888.433.3767 | WWW.PLANETDEPOS.COM
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`Exhibit 1026, Page 4 of 79
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`Videotaped Deposition of Gojko Lalic, Ph.D.
`Conducted on April 12, 2016
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` C O N T E N T S
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`4
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`EXAMINATION OF GOJKO LALIC, Ph.D. PAGE
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`Mr. Doshi 6
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` E X H I B I T S
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` (Previously marked.)
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`Exhibit 1012 Altaire Pharmaceutical, Inc. 51
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` Identification Study STU0328
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`Exhibit 1015 Chromatograms 38
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`Exhibit 1020 Graph 45
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`Exhibit 2016 Declaration of Gojko Lalic, 16
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` Ph.D., PARAGON - EXHIBIT 2016
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`Exhibit 2021 Declaration of Sailaja 31
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` Machiraju, PARAGON - EXHIBIT
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` 2021
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`PLANET DEPOS
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`Exhibit 1026, Page 5 of 79
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`Videotaped Deposition of Gojko Lalic, Ph.D.
`Conducted on April 12, 2016
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`5
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` THE VIDEOGRAPHER: Here begins Disk 1 in the
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`08:58:07
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` videotaped deposition of Dr. Gojko Lalic in the
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` matter of Altaire Pharmaceuticals, Incorporated
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`08:59:42
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`08:59:47
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` versus Paragon Bioteck, Incorporated, in the United
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`08:59:52
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` States Patent and Trademark Office before the Patent
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`08:59:56
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` Trial and Appeal Board, Case Number PGR-2015-00011.
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`08:59:59
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` Today is April 12, 2016, the time on the video
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` monitor is 9 a.m.
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` The videographer today is Michael Takos
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`09:00:08
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`09:00:12
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`09:00:14
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` representing Planet Depos. This video deposition is
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`09:00:18
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` taking place at 701 Fifth Avenue, Suite 5100,
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` Seattle, Washington.
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` Would counsel please voice identify
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` themselves and state whom they represent.
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` MR. DOSHI: Dipu Doshi, Blank Rome,
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` representing Petitioner Altaire. With me is my
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` colleague, Jonathan England.
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` MR. BROWN: Andrew Brown of Wilson Sonsini
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` Goodrich & Rosati on behalf of Patent Owner Paragon,
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`09:00:47
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` and with me is Sonja Gerrard.
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` THE VIDEOGRAPHER: The court reporter today
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`09:00:51
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`09:00:55
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` is Diane Rugh representing Planet Depos. Would the
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`09:00:56
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`PLANET DEPOS
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`Exhibit 1026, Page 6 of 79
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`Videotaped Deposition of Gojko Lalic, Ph.D.
`Conducted on April 12, 2016
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` reporter please swear in the witness.
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` P R O C E E D I N G S
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` Whereupon,
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` GOJKO LALIC, Ph.D.,
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` being first duly sworn or affirmed to testify to the
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` truth, the whole truth, and nothing but the truth,
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` was examined and testified as follows:
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`09:01:00
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`09:01:10
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` EXAMINATION
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` BY MR. DOSHI:
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` Q Good morning.
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` A Good morning.
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` Q Could you state your name for the record,
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` please.
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` A Gojko Lalic.
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` Q Have you been deposed before?
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` A No.
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` Q Okay. Let me just set some ground rules on
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` how this is supposed to work. I'm going to ask some
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`09:01:30
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` questions and you're going to answer to the best of
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`09:01:33
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` your ability. Is that okay?
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`09:01:35
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`Exhibit 1026, Page 7 of 79
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`Videotaped Deposition of Gojko Lalic, Ph.D.
`Conducted on April 12, 2016
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` A Sure.
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` Q If you have any -- if you don't understand
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` my question just let me know and I'll try to
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` rephrase it.
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` A Okay.
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` Q Okay? If you're not done with your answer
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` and I continue with the next question just let me
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` know and I'll let you answer.
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` A Okay.
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` Q All your answers have to be audible, okay,
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` because she's taking it down, the court reporter
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` here to my left. So just try to avoid uh-huhs and
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` huh-uhs, okay?
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` A Okay.
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` Q And you understand you're under oath?
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` A I do.
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` Q And if you need to take a break please let
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` me know and we can take a break. I just ask if
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` there's an outstanding question that I get an answer
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` before we go on break.
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` A No problem.
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`09:02:20
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`09:02:22
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` Q Okay, thank you. Any reason that you're not
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`09:02:22
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`Exhibit 1026, Page 8 of 79
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`
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`Videotaped Deposition of Gojko Lalic, Ph.D.
`Conducted on April 12, 2016
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` able to give truthful or reasonable testimony today?
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`09:02:25
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`8
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` A No.
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` Q You're represented by counsel today?
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` A No.
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` Q What's your understanding as to why you're
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` here today?
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` A To provide testimony about -- that's an
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` interesting question. I'm here to provide -- to
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` answer some questions about my declaration with
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` regards to some data.
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` Q And that was a declaration filed in these
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` proceedings?
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` A Yes.
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` Q To the best of your understanding?
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` A To the best of my understanding, limited
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` understanding.
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` Q Thank you.
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` Were you contacted by Paragon Bioteck?
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` A No.
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` Q Okay. So you were -- were you first
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` contacted by counsel for Paragon?
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` A Yes.
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`PLANET DEPOS
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`Exhibit 1026, Page 9 of 79
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`Videotaped Deposition of Gojko Lalic, Ph.D.
`Conducted on April 12, 2016
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` Q Okay. And who exactly was that?
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` A Sonja Gerrard.
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` THE COURT REPORTER: I'm sorry?
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` THE WITNESS: Sonja Gerrard.
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` Q When did she contact you? When did she
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` first contact you?
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` A I don't remember the actual date, but
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` somewhere around Christmas of last year.
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` Q Did you do anything to prepare for today's
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`09:03:46
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` deposition?
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` A Yes.
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` Q What did you do?
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` A Reviewed the documents, reviewed the
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` declaration, and that's about it.
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`09:04:21
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` Q Do you know which documents you reviewed --
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`09:04:38
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` excuse me.
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`09:04:43
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` Do you know which documents you reviewed in
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`09:04:44
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` preparation for this deposition?
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` A By name, or? I can describe them. I
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` reviewed most of the HPLC data and the optical
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` rotation data and my declaration.
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`09:04:47
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` Q Okay, thank you. Did you review the '623
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`09:05:07
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`Exhibit 1026, Page 10 of 79
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`Videotaped Deposition of Gojko Lalic, Ph.D.
`Conducted on April 12, 2016
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` patent?
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` A No.
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` Q And just going forward, I said the '623
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` patent but the full patent number is U.S. Patent
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`10
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`09:05:12
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` Number 8,859,623. But we can agree that we'll just
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`09:05:20
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` refer to it as the '623 patent?
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` A Okay.
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`09:05:27
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`09:05:29
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` Q Okay. Did you meet with anyone to prepare
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`09:05:31
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` for your deposition today?
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` A No.
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` MR. BROWN: Sorry.
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`09:05:34
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` THE WITNESS: We met for ten minutes before
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` I entered the room here.
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` Q Oh, okay. So other than meeting ten minutes
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`09:05:52
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` prior to the deposition --
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` A Yes. No other --
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` Q -- no other --
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` A -- meetings of any sort.
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` Q Thank you.
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` MR. BROWN: Last week.
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` THE WITNESS: I understood the question to
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` mean this morning or today did I do anything.
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`09:06:13
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`Exhibit 1026, Page 11 of 79
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`Videotaped Deposition of Gojko Lalic, Ph.D.
`Conducted on April 12, 2016
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` Q Not today.
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` A In general --
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` Q It's a little bit more open-ended.
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` A -- like ever? Oh, okay. So we met --
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` MR. BROWN: And I would just caution you not
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`09:06:22
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` to reveal the substance of our conversations. But
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`09:06:24
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` you can answer the question.
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`09:06:26
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` THE WITNESS: So we met, that was on Friday
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`09:06:27
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` last week. We met for a couple of hours in
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` preparation for this meeting.
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` Q And who did you meet with?
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` A I met with Sonja Gerrard again and --
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` MR. BROWN: Andy.
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` THE WITNESS: Andy. Thank you.
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` Q And you said that was for a couple of hours?
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`09:06:58
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` A Yes.
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`09:07:00
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` Q And did you look at any documents in those
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`09:07:03
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` meetings?
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` A Yes, I did.
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` Q In preparation for today's deposition did
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` you review Altaire's petition?
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`09:07:08
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`09:07:23
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` A At some point I might have looked at it, but
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`09:07:31
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`Exhibit 1026, Page 12 of 79
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`Videotaped Deposition of Gojko Lalic, Ph.D.
`Conducted on April 12, 2016
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`12
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` it wasn't -- I probably wouldn't be able to say much
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`09:07:35
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` about it. I mostly focused on the data.
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` Q Did you review Patent Owners' response in
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` preparation for today's deposition? This is the
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` paper that Paragon filed.
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`09:07:38
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`09:07:44
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`09:07:48
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`09:07:51
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` A If that's Sawaya -- I don't know the name, I
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`09:07:52
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` can't pronounce the name, but if that's what you're
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`09:07:57
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` referring to, the stuff that -- the declaration that
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`09:08:00
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` went with the data, I did review that, yes.
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` Q Okay. So the -- okay.
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` Did you review any deposition transcript?
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` A I did not. I don't believe I did.
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`09:08:02
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`09:08:43
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` Q Have you reviewed any confidential documents
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`09:08:51
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` relating to these proceedings in preparation for
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` your deposition today?
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` A I may need help because I'm not sure really
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` what that means.
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` Q Any documents that were marked confidential
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` that were not included in --
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` A Did not.
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`09:08:55
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`09:09:10
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` Q Okay. Did you speak to anyone at Paragon in
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`09:09:11
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` preparation for your deposition today?
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`09:09:18
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`PLANET DEPOS
`888.433.3767 | WWW.PLANETDEPOS.COM
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`Exhibit 1026, Page 13 of 79
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`
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`Videotaped Deposition of Gojko Lalic, Ph.D.
`Conducted on April 12, 2016
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`13
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` A At one point on the phone I exchanged hellos
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`09:09:21
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` with someone from Paragon, but that's about it. And
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`09:09:28
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` I'm actually not sure, I don't remember the name of
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`09:09:36
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` the person.
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`09:09:40
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` Q Did you speak to any of the named inventors?
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`09:09:51
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` A Unless that person I exchanged hellos with
`
` is a named inventor, I did not.
`
` Q Are you being compensated for your time in
`
` connection with these proceedings?
`
` A Can you repeat the question? I didn't hear
`
` it.
`
` Q Let me strike that.
`
` Are you being compensated for your time in
`
` connection with this deposition?
`
` A I think so, yes.
`
` Q How much are you being compensated?
`
` A I believe it's $350 an hour.
`
` Q And were you compensated for your time in
`
` preparing the declaration?
`
` A I have not been compensated yet, I guess,
`
` but I hope I will be.
`
` Q Have you submitted an invoice to Paragon?
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`Exhibit 1026, Page 14 of 79
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`
`
`Videotaped Deposition of Gojko Lalic, Ph.D.
`Conducted on April 12, 2016
`
` A I did not.
`
` Q Okay. The time you spent on the
`
` declaration, would that also be at a $350 per
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` hour --
`
` A That's my understanding.
`
` Q -- compensation? Apart from the $350 per
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`09:12:18
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`09:12:22
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`09:12:26
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`09:12:26
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` hour, have you received any additional compensation
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`09:12:45
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` from Paragon or Paragon owners?
`
` A No.
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`09:12:46
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`09:12:50
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` Q Any other compensation that's not monetary?
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`09:12:58
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` A No.
`
`09:13:06
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` Q Do you stand to benefit in any way based on
`
`09:13:10
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` the outcome of this proceeding?
`
` A Not that I can imagine.
`
` Q Do you have any ownership interest in
`
` Paragon?
`
` A I do not.
`
` Q Is Paragon funding any grants to you or
`
` your --
`
` A No. I wish.
`
` Q Who wrote the declaration?
`
`09:13:12
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`09:13:15
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`09:13:19
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`09:13:21
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`09:13:21
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`09:13:49
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`09:13:53
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`09:14:08
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` A Joint effort. Part was by Sonja Gerrard and
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`09:14:11
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`Exhibit 1026, Page 15 of 79
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`
`
`Videotaped Deposition of Gojko Lalic, Ph.D.
`Conducted on April 12, 2016
`
`15
`
` someone else who was on the other side, I'm not sure
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`09:14:19
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` who else was involved. But Sonja for sure, and I
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` did.
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` Q Did you write portions of it yourself?
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` A Sure.
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`09:14:21
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`09:14:26
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`09:14:26
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`09:14:28
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` Q Would you be able to identify which portions
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`09:14:32
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` you wrote yourself?
`
` A Not with absolute certainty, but there are
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`09:14:35
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`09:14:38
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` probably things I could point out that are mine that
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`09:14:43
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` I could reasonably be confident that they are mine.
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`09:14:46
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` But every word, I couldn't.
`
` Q Have you previously worked with any
`
` attorneys at Wilson Sonsini?
`
` A No, I did not.
`
` Q Have you ever worked in private industry?
`
` A No, I did not.
`
` Q Have you ever worked in the pharmaceutical
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`09:14:51
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` formulation manufacturing or distribution industry?
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`09:15:49
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` A No, I have not.
`
` Q You previously testified that you have not
`
` been deposed before; is that correct?
`
` A If I properly understand what means being
`
`09:15:52
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`09:15:56
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`09:15:58
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`09:16:02
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`Exhibit 1026, Page 16 of 79
`
`
`
`Videotaped Deposition of Gojko Lalic, Ph.D.
`Conducted on April 12, 2016
`
` deposed, no, I have not.
`
` Q Have you ever testified at trial?
`
` A I have never testified at a trial.
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`16
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`09:16:11
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` Q Have you ever -- have you been a testifying
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`09:16:19
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` expert before?
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` A No, never.
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`09:16:28
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`09:16:29
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` Q I went through the background very quickly.
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`09:16:53
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` (Exhibit 2016, previously marked, is
`
` attached to the transcript.)
`
`09:16:53
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`09:16:53
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` Q All right, so I'm handing you Exhibit 2016.
`
`09:17:00
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` Just take a moment to look through that and let me
`
`09:17:07
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` know when you're done.
`
` A It looks familiar.
`
` Q Okay. Do you recognize that document?
`
` A Yes, I do.
`
` Q What do you recognize it to be?
`
`09:17:11
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`09:17:32
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`09:17:35
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`09:17:38
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`09:17:39
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` A It's a declaration that I wrote, co-wrote.
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`09:17:41
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` Q I want to turn your attention to Paragraph 9
`
`09:18:32
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` of your report on which is Page 2.
`
` A Uh-huh, yes.
`
`09:18:39
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`09:18:41
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` Q Paragraph 9 of your report you discuss what
`
`09:18:42
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` you have been asked to do; is that correct?
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`09:18:48
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`Exhibit 1026, Page 17 of 79
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`
`
`Videotaped Deposition of Gojko Lalic, Ph.D.
`Conducted on April 12, 2016
`
` A Yes, it does.
`
`17
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`09:18:51
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` Q And does Paragraph 9 accurately state what
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`09:18:53
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` you address in your report?
`
` A I believe so.
`
` Q And Paragraph 10 through 13 state the
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` summary of your opinion; is that correct? I'm
`
` sorry, let me strike that.
`
` In Paragraphs 10 through 13 state the
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` summary of your opinions; is that correct?
`
` A Yes.
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`09:18:56
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` Q Does your report address whether the claims
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`09:20:09
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` of the '623 patent are non-obvious?
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`09:20:11
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` A Could you repeat, because you were turned
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`09:20:15
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` away from me and it's kind of hard to hear.
`
` Q Yeah, sure.
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`09:20:16
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`09:20:20
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` Does your report address whether the claims
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`09:20:21
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` of the '623 patent are non-obvious?
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`09:20:23
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` A That doesn't sound like something I engaged
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`09:20:28
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` in in any way.
`
` Q Your understanding is that you did not
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`09:20:32
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`09:20:34
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` address whether the claims of the '623 patent are
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`09:20:38
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` non-obvious; correct?
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`09:20:41
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`Exhibit 1026, Page 18 of 79
`
`
`
`Videotaped Deposition of Gojko Lalic, Ph.D.
`Conducted on April 12, 2016
`
` A Yes.
`
`18
`
`09:20:42
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` Q In general terms, how would you characterize
`
`09:21:11
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` the substance of your report?
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`09:21:15
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` A How would I characterize the substance of my
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`09:21:18
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` report? I'm not sure -- I'm not sure what that
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` means.
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` Q Just generally speaking, how would you --
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` what do you think was the scope of your report?
`
` MR. BROWN: Objection.
`
` Q Well, let me strike it, actually.
`
` You've reviewed the '623 patent; correct?
`
` A I at some point read through the patent,
`
` yes.
`
` Q Okay. And in your opinion, what is the
`
` subject matter of the '623 patent?
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`09:21:21
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`09:21:26
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`09:21:27
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`09:22:17
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` A Very quickly, it seemed that it has nothing
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`09:22:19
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` to do with what I've been asked to do. So I
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` honestly couldn't tell you much except that it
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` didn't have much to do with my area which was to
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`09:22:23
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`09:22:26
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`09:22:29
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` analyze HPLC data and optical rotation data. And I
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`09:22:34
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` focused on that.
`
` So I read through it but didn't find
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`09:22:39
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`09:22:40
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`Exhibit 1026, Page 19 of 79
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`
`
`Videotaped Deposition of Gojko Lalic, Ph.D.
`Conducted on April 12, 2016
`
` anything useful for me. And that was at the
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`09:22:43
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` beginning, so I really don't know much about it.
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`09:22:46
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`19
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` Q Thank you.
`
` A Sure.
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`09:22:51
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`09:22:51
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` Q Looking at Page 5 of your report, let me
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`09:23:55
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` know when you get there.
`
` A I'm there.
`
` Q Okay. In Paragraph 19 you say,
`
` "Phenylephrine contains one chiral center."
`
` What is a chiral center?
`
`09:24:02
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`09:24:03
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`09:24:04
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`09:24:07
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`09:24:09
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` A Chiral center is usually a carbon atom that
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`09:24:12
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` contains four non-identical substituents.
`
` THE COURT REPORTER: Last word?
`
` THE WITNESS: Substituents.
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`09:24:24
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`09:24:24
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`09:24:38
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` MR. BROWN: I was going to try to spell it
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`09:24:38
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` but then I realized I'd probably get it wrong.
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`09:24:41
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` Q And what makes it a chiral center in that
`
`09:24:51
`
` regard?
`
`09:24:56
`
` A Could you rephrase it in some way, because
`
`09:25:03
`
` I'm not sure where to go.
`
` Q Well, let's just go to Paragraph 20.
`
` A Okay.
`
`09:25:07
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`09:25:12
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`09:25:15
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`Exhibit 1026, Page 20 of 79
`
`
`
`Videotaped Deposition of Gojko Lalic, Ph.D.
`Conducted on April 12, 2016
`
` Q Well, let's go back to Paragraph 19, I'm
`
`09:25:16
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` sorry. You say that, "Phenylephrine contains one
`
`09:25:19
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`20
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` chiral center." Do you see that?
`
` A Yes.
`
` Q And because it only has -- and I'm
`
` paraphrasing here --
`
` A Uh-huh.
`
` Q -- one chiral center, it has two
`
` stereochemical forms called enantiomers.
`
` Do you see that?
`
` A Yes.
`
` Q Can it have more than two?
`
` A More than two?
`
` Q Well, let me strike that question, it's a
`
` bad question.
`
`09:25:24
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`09:25:26
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`09:25:46
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`09:25:48
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` Can this phenylephrine -- does phenylephrine
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`09:25:49
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` have more than two enantiomers?
`
` A No.
`
` Q And what is an enantiomer?
`
`09:25:56
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`09:26:09
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`09:26:09
`
` A It's a complicated question, but it's almost
`
`09:26:16
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` a circular definition. Enantiomers are molecules
`
`09:26:19
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` that are mere images of each other but are not
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`09:26:22
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`Exhibit 1026, Page 21 of 79
`
`
`
`Videotaped Deposition of Gojko Lalic, Ph.D.
`Conducted on April 12, 2016
`
` superimposable. And they are subs because they
`
`21
`
` contain chiral centers.
`
` Q Thank you.
`
` In your report you've been asked to analyze
`
` HPLC-based analytic methods.
`
` A Yes.
`
` Q What is HPLC?
`
` A It's an analytical or preparative technique
`
` for separation of compounds.
`
` Q And what types of compounds can be
`
` separated?
`
` A Many different types, but in general I'm
`
` familiar with uses in organic chemistry where
`
` essentially all organic compounds can in some
`
` contexts be separated by HPLC.
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`09:26:29
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`09:27:50
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` Q And how can one tell that the compounds have
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`09:27:57
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` been separated? In other words, what's the output
`
` of an HPLC analytic tool that would allow you to
`
` understand that compounds have been separated?
`
` A Output is generally in the form of a
`
`09:28:04
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`09:28:09
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`09:28:15
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`09:28:22
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` chromatogram that shows how a particular property of
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`09:28:29
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` choice, and we can talk about what is property of
`
`09:28:32
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`Exhibit 1026, Page 22 of 79
`
`
`
`Videotaped Deposition of Gojko Lalic, Ph.D.
`Conducted on April 12, 2016
`
`22
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` choice, how does it change in a eluent from the HPLC
`
`09:28:34
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` over time.
`
` THE COURT REPORTER: In what?
`
` THE WITNESS: Eluent. And I can elaborate
`
` on property of choice if you're interested.
`
` Q Well, I was going to get there, yes.
`
` So what properties of choice -- what do you
`
` mean by properties of choice?
`
` A Most common is UV absorbents, but we can
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`09:29:25
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` also track many, many other physical properties. We
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`09:29:54
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` can look at the mass of compounds that are contained
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`09:29:59
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` in the eluent at any particular time, we can look at
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`09:30:02
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` optical rotation, we can look at other different
`
` properties. But UV absorbancy is the most common
`
` one.
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`09:30:08
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`09:30:11
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`09:30:18
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` Q I'd like to turn your attention to Paragraph
`
`09:30:55
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` 27, Page 7.
`
` A I see.
`
` Q You say, "Assignment of chromatogram peaks
`
` to individual compounds within a sample typically
`
` involves either upstream HPLC validation
`
` experiments ..."
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`Exhibit 1026, Page 23 of 79
`
`
`
`Videotaped Deposition of Gojko Lalic, Ph.D.
`Conducted on April 12, 2016
`
` What did you mean by that?
`
` A So big question in interpreting the HPLC
`
` data is evaluating the changes in the specific
`
` property like, say, UV absorbents over time to
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` presence of any specific compound. And in order to
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` be able with some certainty to connect the presence
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` of a change in UV absorbents, which we can call
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` peak, with a specific compound, we have to be able
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` to either find another way to make sure that that's
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` what we think has happened.
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` So that either involves taking a known
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` sample of a known compound in a pure form, analyzing
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` it in a separate experiment by HPLC, and then
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` assigning that specific peak under specific
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` conditions comes from the presence of that specific
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` compound. So that would be an upstream validation
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` method. So knowing how specific compounds in their
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` pure form under controlled conditions behave can
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` help us later assign the presence of that compound
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` based on the HPLC data.
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` Q Thank you. And how about downstream
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` specific identification methods, also in Paragraph
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`Exhibit 1026, Page 24 of 79
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`Videotaped Deposition of Gojko Lalic, Ph.D.
`Conducted on April 12, 2016
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` 27; what did you mean by that?
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` A So under particular conditions, it is
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` possible to actually isolate the material that's
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` eluted from the HPLC column and analyze it after it
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` went through the HPLC and after we obtained a
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` chromatogram, and then determine that that peak that
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` we saw contains a compound that we can identify by
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` other analytical techniques such as NMR or mass spec
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` or a combination of those and other ones.
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` Q In Paragraph 28 you discuss a validation
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` experiment that may take the form of a series of
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` three HPLC runs. Do you see that?
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` A Yes.
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` Q Are there other experiments that could be
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` done to validate a HPLC experiment?
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` A I can imagine that there are, but what I
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` described is standard in my experience. It's the
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` simplest one can think of that satisfies a general
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` requirement.
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` Q And are all three runs that you describe
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` here in Paragraph 28 necessary to validate an
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` experiment?
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`Exhibit 1026, Page 25 of 79
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`Videotaped Deposition of Gojko Lalic, Ph.D.
`Conducted on April 12, 2016
`
` A Generally, I would say yes.
`
` Q Generally, but not always?
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` A Depending on what is the goal of the
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` experiment. If you can tell me what the goal of the
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` experiment is, I can be more specific whether all
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` three are required.
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` Q In this context, in this declaration we're
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` discussing the separation of R-phenylephrine from
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` S-phenylephrine --
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` A Uh-huh.
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` Q Right? So in that context, is this the
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` only -- is Paragraph 28 the only method by which you
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` believe an HPLC experiment can be validated?
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` A I would hesitate to say "only," but this is
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` generally accepted as a standard way of validating
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` those experiments, yes.
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` Q But there could be other ways?
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` A It's hard for me to exclude other
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` experiments, but I would -- I think I would feel
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` comfortable saying that all of the other experiments
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` I can imagine would be significantly more
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` complicated than this.
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`Exhibit 1026, Page 26 of 79
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`Videotaped Deposition of Gojko Lalic, Ph.D.
`Conducted on April 12, 2016
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` Q Understood, thank you.
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` Turn to Paragraph 24 of your declaration.
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` It's on Page 6. Do you see that?
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` A Yes.
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`26
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` Q All right. It appears you acknowledge that
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` Sigma-Aldrich sells R-phenylephrine hydrochloride
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`09:37:47
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` under the Product Number P6126; is that correct?
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` A Yes.
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` Q The Sigma-Aldrich catalog indicates the
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` purity of the product is greater than 99 percent;
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` correct?
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` A Yes.
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`09:38:03
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` Q Okay. Would you have any reason to believe
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` the catalog is incorrect?
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` MR. BROWN: Objection.
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` THE WITNESS: Do you want me to answer?
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` Q Yeah.
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` A No, there's no reason.
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`09:38:32
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` Q Okay. Does the method of testing affect the
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`09:38:35
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` purity of the product? I'm sorry.
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`09:38:45
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` Does the method of testing affect the purity
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`09:38:48
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` of the Sigma-Aldrich product?
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`09:38:51
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`Exhibit 1026, Page 27 of 79
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`Videotaped Deposition of Gojko Lalic, Ph.D.
`Conducted on Apr
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