`
`Transcript of Robert O. Williams,
`III, Ph.D.
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`Date: November 15, 2022
`Case: Slayback Pharma LLC -v- Eye Therapies LLC (PTAB)
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`Planet Depos
`Phone: 888-433-3767
`Fax: 888-503-3767
`Email: transcripts@planetdepos.com
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`WORLDWIDE COURT REPORTING & LITIGATION TECHNOLOGY
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`Slayback Exhibit 1054, Page 1 of 33
`Slayback v. Eye Therapies - IPR2022-00142
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`Transcript of Robert O. Williams, III, Ph.D.
`November 15, 2022
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` REMOTE APPEARANCES
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`ON BEHALF OF THE PETITIONER
`SLAYBACK PHARMA LLC:
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` Linnea P. Cipriano
` GOODWIN PROCTER LLP
` 620 Eighth Avenue
` New York, New York 10018
` (212) 459-7258
` lcipriano@goodwinlaw.com
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`ON BEHALF OF THE PATENT OWNER
`EYE THERAPIES, LLC:
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` Caitlin E. O'Connell
` Justin J. Hasford
` FINNEGAN HENDERSON FARABOW GARRETT & DUNNER LLP
` 901 New York Avenue, NW
` Washington, D.C. 20001-4413
` (202) 408-4000
` caitlin.o'connell@finnegan.com
` justin.hasford@finnegan.com
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`VIDEOGRAPHER:
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` Kollin Casarez
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`ALSO PRESENT:
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` Emily Dunn, PlanetDepos Tech
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` UNITED STATES PATENT AND TRADEMARK OFFICE
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` _________________________
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` BEFORE THE PATENT TRIAL AND APPEAL BOARD
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` _________________________
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` SLAYBACK PHARMA LLC,
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` Petitioner
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` v.
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` EYE THERAPIES, LLC,
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` Patent Owner
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` _________________________
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` Case IPR2022-00142
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` Patent No. 8,293,742
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` _________________________
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` REMOTE VIDEOTAPED ORAL DEPOSITION OF
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` ROBERT O. WILLIAMS, III, Ph.D.
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` Austin, Texas
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` November 15, 2022 - 8:51 a.m.
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`Reported by:
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`Micheal A. Johnson, RDR, CRR
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`Job No. 471475
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` REMOTE VIDEOTAPED ORAL DEPOSITION OF
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`ROBERT O. WILLIAMS, III, Ph.D., produced at the
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` INDEX
` ROBERT O. WILLIAMS, III, Ph.D.
` November 15, 2022
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`instance of the Petitioner, in the above-styled
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`APPEARANCES 3
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`and numbered cause on the 15th day of
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`PROCEEDINGS 6
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` EXAMINATION OF ROBERT O. WILLIAMS, III, Ph.D.:
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` BY MS. CIPRIANO 6
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`CERTIFICATE OF SHORTHAND REPORTER 51
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`November, 2022, at 8:51 a.m., before Micheal A.
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`Johnson, RDR, CRR, Notary Public in and for the
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`State of Texas, reported by realtime stenographic
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`means, at the offices of Wittliff Cutter, PLLC,
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`1209 Nueces Street, Austin, Texas.
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`Slayback Exhibit 1054, Page 2 of 33
`Slayback v. Eye Therapies - IPR2022-00142
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`

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`Transcript of Robert O. Williams, III, Ph.D.
`November 15, 2022
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` DEPOSITION EXHIBITS
` ROBERT O. WILLIAMS, III, Ph.D.
` November 15, 2022
`
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`Exhibit 1001 U.S. Patent 8,293,742 42
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`Exhibit 1025 2013 Pasquali Article, 27
` Dilute Brimonidine to
` Improve Patient Comfort and
` Subconjunctival Hemorrhage
` After LASIK
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`Exhibit 2018 July 8, 2002 Press Release, 38
` Allergan to focus on
` Alphagan-P, discontinue
` Alphagan
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`Exhibit 2021 Declaration of Robert O. 11
` Williams, III, Ph.D.
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`7
` A Yes. My name is Robert, middle initial O,
`Williams, III.
` Q Have you ever been deposed before?
` A Yes, I have.
` Q About how many times?
` A Oh, I don't count. I mean, I've been
`serving as a consultant for most of my academic
`career, so -- but I don't know an exact number.
` Q And have most of those been associated
`with patent infringement cases or patent validity
`cases?
` A Most have, yes.
` Q Okay. Have you served as a formulation
`expert in those cases?
` A Yes, I have.
` Q Have -- can you give me some examples of
`the types of formulations that you've given
`opinions on in patent cases?
` A The types of formulations have been liquid
`formulations, sterile formulations, dry products
`like capsules, tablets. It's really been a
`variety of different delivery systems and dosage
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`forms.
` PROCEEDINGS
` Q Have you ever provided expert testimony on
` THE VIDEOGRAPHER: Here begins the media
`an eye drop formulation prior to this case?
`No. 1 in the videotaped deposition of Dr. Robert
` A Yes, I have.
`Williams. We are on the record at 8:51 a.m.
` Q And in what case was that?
` (Witness sworn.)
` A Well, I don't remember the case number or
` MS. CIPRIANO: This is Linnea Cipriano of
`anything, but the product was Prolensa.
`Goodwin representing petitioner.
` Q Was that the only time you've given an
` MS. O'CONNELL: Caitlin O'Connell from
`opinion in a patent case about an eye drop?
`Finnegan on behalf of the patent owner and the
` A Sitting here, that's all I recall right
`witness. And with me is my colleague Justin
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`now.
`Hasford.
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` Q Okay. This deposition will likely go in
` ROBERT O. WILLIAMS, III, Ph.D.,
`12
`line with your previous depositions, but to make
`called as a witness, having been duly sworn, was
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`sure we're on the same page, I'd like to go over a
`examined and testified as follows:
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`few ground rules.
` EXAMINATION
`15
` As you know, I'm going to be asking you
`BY MS. CIPRIANO:
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`questions today and your answers to those
` Q Good morning, Dr. Williams. Thank you for
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`questions will be under oath as if you were
`your patience this morning.
`18
` A Good morning.
`testifying in court. Do you understand that?
`19
` A Yes.
` Q As I said, my name is Linnea Cipriano and
`20
` Q And during the course of the deposition,
`I'm going to be taking your deposition today.
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`your counsel may make objections; but unless
`Could you please state your name for the record.
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`Slayback Exhibit 1054, Page 3 of 33
`Slayback v. Eye Therapies - IPR2022-00142
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`

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`Transcript of Robert O. Williams, III, Ph.D.
`November 15, 2022
`9
`you've been instructed not to answer, I expect you
`to answer my questions; is that fair?
` A Yes.
` Q As was noted previously in our
`discussions, I'm going to try my best not to speak
`over you and I just ask that you wait till I
`finish my questions before starting your answer.
`Does that make sense?
` A Yes.
` Q We may take breaks from time to time.
`Please let me know if you need a break. I just
`ask that we will finish a question and answer
`before we take any break. Does that make sense?
` A Yes, I understand.
` Q Okay. I'm sure that my questions will not
`be perfect today, so please ask -- if you don't
`understand anything or if anything is confusing to
`you about my questions, please ask. But if you
`answer my question, I'm going to assume that you
`understood it; is that fair?
` A Yes, I understand.
` Q And you understand that while I'm asking
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` A I looked at all of them.
` Q With whom did you speak regarding this
`deposition?
` A With attorneys at Finnegan, Mr. Hasford
`and Ms. O'Connell.
` Q Did you have conversations with any of the
`other experts that submitted declarations in
`connection with this proceeding?
` A I did not, no.
` Q You prepared a declaration in connection
`with this IPR proceeding, correct?
` A Yes, I did.
` Q Okay.
` MS. CIPRIANO: If we could take a look at
`Exhibit 2021. And thank you for your assistance,
`Caitlin.
` THE WITNESS: Can I just have the whole
`notebook?
` (Deposition Exhibit 2021 marked for
`identification.)
` MS. O'CONNELL: Just for the record, I'm
`handing him a binder that has -- has the first
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`exhibit -- or at the first tab his declaration,
`which is Exhibit 2021, but it also has the other
`materials considered, just so he doesn't have a
`bunch of loose leaf paper floating around.
` MS. CIPRIANO: Understood. I appreciate
`that.
`BY MS. CIPRIANO:
` Q Dr. Williams, I just ask if you turn to
`another exhibit in your binder, if you could just
`let me know; is that fair?
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` A Yes, I will.
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` Q Okay. So we could take a look at
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`Exhibit 2021. Do you recognize this as the
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`declaration that you signed and submitted in this
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`proceeding?
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` A Yes. It is my declaration, yes.
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` Q And at a high level, how did you prepare
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`your declaration?
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` A Well, I understood what I was asked to do,
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`and then I -- in addressing some of Dr. Laskar's
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`opinions, I basically came up with, you know,
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`what -- where I agreed with him and where I
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`you questions today, you're not permitted to
`discuss the substance of your testimony with your
`attorneys. Do you understand that?
` A I understand that, yes.
` Q Is there any reason you would not be able
`to answer my questions fully and truthfully this
`morning?
` A There's not, no.
` Q Did you prepare for today's deposition?
` A Yes, I did.
` Q And without revealing any privileged
`information, with -- at a high level, what did you
`do to prepare for today's deposition?
` A Yes. I reviewed my declaration. I
`reviewed the '742 patent. I reviewed documents
`that I cited in my declaration. I reviewed
`Dr. Laskar's report, Dr. Sher's report,
`Dr. Noecker's report, Dr. Davis's report. That's
`generally what I reviewed to prepare for today.
` Q When you said you reviewed the documents
`cited in your declaration, do you recall any
`specific documents you looked at?
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`Slayback Exhibit 1054, Page 4 of 33
`Slayback v. Eye Therapies - IPR2022-00142
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`Transcript of Robert O. Williams, III, Ph.D.
`November 15, 2022
`13
`disagreed with him. And so that's generally how I
`came about writing my declaration.
` Q Did you draft your declaration?
` A Yes, I did.
` Q Are there any corrections or changes that
`you'd like to make to your declaration at this
`point?
` A I mean, there was a couple of clerical
`errors that I noted in my review. They were --
`they're not substantial. One's I think in
`paragraph 104 and paragraph 115, but other than
`that, I don't have any changes.
` Q And these changes would not change the
`meaning of the substance of your testimony?
` A Not at all, no.
` Q You understand you're being presented as
`an expert in this proceeding; is that right?
` A Yes.
` Q And what is your area of expertise?
` A My area of expertise is in drug delivery
`and drug product formulation and pharmaceutical
`technology. That's the area that I've worked in
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` And then from a research standpoint, I
`conduct research. I have a research laboratory
`that has graduate students and postdoctoral
`fellows and visiting scholars from around the
`world. And we -- I have a -- I oversee a research
`program, we publish -- we file intellectual
`property and conduct research. And, again --
` Q I'm -- things have frozen on my end.
` A No. I still -- y'all are still moving and
`I hear you.
` Q Okay.
` MS. DUNN: You did freeze in the middle of
`your last answer, Doctor. My apologies. Are you
`able to hear us, Doctor?
` THE WITNESS: I do. I'm not sure what I'm
`supposed to do, so...
`BY MS. CIPRIANO:
` Q Okay. So what I heard -- the last thing I
`heard was that you oversee a research program that
`you publish and you follow intellectual property
`and conduct research. I don't know if you had
`more to your answer.
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`for my professional career.
` Q You are currently employed, correct?
` A I am, yes.
` Q What is your current title?
` A I'm a professor of pharmaceutics at the
`College of Pharmacy at The University of Texas at
`Austin.
` Q And what are your responsibilities in that
`role?
` A So in that role I have a teaching
`responsibility, so I teach graduate-level courses,
`graduate to -- to graduate students, and I teach a
`course in -- to our PharmD students in the
`professional curriculum. That's teaching. And
`the subject that I teach is dealing with drug
`delivery, drug delivery systems, pharmaceutical
`formulations and pharmaceutical technology.
` Then I have a service role. I serve as
`division head and chair of our -- the molecular
`pharmaceutics and drug delivery division within
`our college. And I serve on a variety of
`different committees within the college.
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` A No. I finished the part of research
`with -- the research is, you know, obviously all
`within my area of expertise.
` Q Okay. If we could turn to Appendix A to
`Exhibit 2021. Which I believe starts on
`page 56 --
` A Okay. I'm -- sorry, I'm there.
` Q Okay. Great. And Appendix A to your
`declaration is your CV; is that correct?
` A It is a copy of my CV, yes.
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`of your CV, you have a section called Positions
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`Held. Do you see that?
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` A I'm sorry, what -- a section -- oh, for
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`Positions Held?
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` A Yes, I see it. Yes.
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` Q Okay. So I just want to go through a
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`couple of your positions in the companies that you
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`list here. So No. 2 listed on your list of
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`positions held is a group leader for Eli Lilly &
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`Company. What were your responsibilities in that
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`Slayback v. Eye Therapies - IPR2022-00142
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`Transcript of Robert O. Williams, III, Ph.D.
`November 15, 2022
`17
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`development standpoint, when you work with sterile
`solutions for parenteral administration, mine were
`geared towards intravenous, intramuscular
`subcutaneous. Those liquids were also -- they had
`a lot of the same types of properties as ocular,
`for application to the eye. When I was at
`Rhone-Poulenc Rorer, all of my experience was for
`the parenteral, not ophthalmic.
` Q Okay. And then so we'll skip over your
`position at UT Austin for now and we'll come back
`to that in a moment. The next company, though, on
`your list is PharmaForm. What were your
`responsibilities at PharmaForm?
` A So PharmaForm was a start-up company that
`myself and another group started, and it was a
`contract manufacturing organization. So at
`PharmaForm, the -- what we did there was we did
`both product development, so just a wide variety
`of different types of pharmaceutical products,
`different routes of administration, as well as
`analytical testing there. So that's primarily
`what that company did.
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`role?
` A In this position -- well, in all my time
`at Eli Lilly, I had responsibility for formulating
`liquids and solids. So the liquids would -- were
`solutions. They were -- also included
`suspensions, both as a liquid and for
`reconstitution at point of use. And I formulated
`solid dosage forms, capsules, tablets, and those
`would include both immediate release and a
`modified release.
` Q While you were at Eli Lilly, did you
`formulate any eye drops?
` A I did not, no.
` Q In No. 3 on your list of positions held
`you list a director for Duramed Pharmaceuticals.
`What was your position at Duramed Pharmaceuticals?
` A Yeah. So at Duramed I directed a group of
`product development scientists, and my group had
`responsibility for developing, similar to Lilly,
`liquid dosage forms, both solutions and
`suspensions, as well as solid dosage forms.
` Q Did you formulate any eye drops while you
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`were at Duramed?
` A I did not, not there.
` Q So the next company listed in your list of
`positions held is Rhone-Poulenc, if I'm
`pronouncing that correct, Rorer Pharmaceuticals.
`What was your -- what were your responsibilities
`at that company?
` A Yeah. So here my group was responsible --
`well, in this No. 4, was responsible for liquids.
`And that would be the -- both sterile liquids and
`nonsterile liquids. So the sterile liquids would
`include the parenteral dosage forms, and I was
`also formulated inhaled drugs. So particularly
`dry powder inhalers and pressurized meter dose
`inhalers, as well as an aqueous pump spray, so an
`aqueous liquid for nasal delivery. And then I
`also formulated topical products for application
`onto the skin. And I also had -- my group had
`responsibility for solid dosage forms as well.
` Q So in your time at that company, did you
`formulate any eye drop formulations?
` A Not eye drops. I had -- so from a
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` Q Were any of the products you developed or
`tested eye drops?
` A They -- not at -- not at PharmaForm, no.
` Q So the next company on your list is you
`held a position at the board of directors of Akela
`pharmaceuticals -- or Akela Pharma, excuse me.
`What was your -- what were your responsibilities
`in that position?
` A So Akela Pharma had purchased PharmaForm.
`So the role at PharmaForm continued. And then
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`another company Enavail LLC. What were your
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`responsibilities at Enavail?
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` A Yeah. So Enavail was a company that
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`licensed intellectual property from The University
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`of Texas at Austin from my lab. And they used
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`that technology to -- it's a part -- it was a
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`series of particle engineering technologies. So
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`they used that technology to formulate a variety
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`Transcript of Robert O. Williams, III, Ph.D.
`November 15, 2022
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` A We did not.
` Q Has that been a continuous project since
`the early 2000s?
` A It has not, no. It -- that project
`lasted, I don't know, five or six years, and
`then -- and then it ended.
` Q And have you done any work on eye drops
`since then?
` A Well, I've done, you know, a lot of work
`with sterile liquids for parenteral administration
`that, again, have some of the same considerations
`that they would have for an ophthalmic or nasal or
`a lot of the same principles apply; but since then
`I have not done specifically, that I recall
`anyway, for an eye drop.
` Q And you're an inventor on a number of
`patents; is that correct?
` A Yes.
` Q And are any of your patents directed to
`eye drop formulations?
` A Some of my patents, they could be. The
`product that we're talking about in the particle
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`engineering could be directed to an ophthalmic
`application, but we -- you know, that was -- we
`haven't actually done that in the lab since
`that -- my collaboration in that product
`development effort with a colleague at one of our
`medical schools, a retinal surgeon.
` Q You're not an expert in chemistry,
`correct?
` A I -- I mean, I have fundamental knowledge
`of chemistry, but I wouldn't consider myself an
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`expert in chemistry.
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` Q And you're not an ophthalmologist?
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` A That is true.
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` Q You're not presenting any opinions in this
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`case on the economics of eye -- the market for eye
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`drops, correct?
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` A That is true, I'm not.
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` Q And you're not an expert in commercial
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`marketing, correct?
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` A I'm not, no.
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`of drugs for different routes of administration.
` Q Were any of those routes of administration
`an eye drop?
` A No.
` Q And then also in your declaration you
`mentioned a position at TFF. Do you recall that?
` A Yes.
` Q And what is -- what are your
`responsibilities with respect to TFF?
` A Yeah. So TFF Pharmaceuticals, it's a
`company that licensed intellectual property from
`my laboratory. I'm a coinventor on most of the
`intellectual property. And it's drug
`formulation-type application particle engineering.
`And it's applied right now to inhaled drugs,
`nasally-delivered drugs. So there's sterile --
`there's a sterile manufacturing part, sterile
`development for the products for inhalation.
` Q In that role, are you developing
`technology for eye drops?
` A At the present time, no. We've talked
`about it, but not at the present time.
`
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` Q You discussed and you also mention in your
`CV on the next page, on page 3, your current --
`that you currently run a research program. And on
`page 3 you list Current Research Interests. Do
`you recall that?
` A Yes.
` Q Do any of these current research
`interests, are any of them directed to formulating
`eye drops?
` A Yes. No. 2 is. And so I have had a
`research collaboration with a retinal surgeon at
`one of our medical schools. And so I did -- I had
`several students working on an ophthalmic sterile
`liquid for that application.
` Q And when did that start?
` A That started in probably the early 2000s,
`not long after I came to UT Austin.
` Q Have you published any articles on that
`technology?
` A We did not, no.
` Q Have you filed any patents on that
`technology?
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`Slayback Exhibit 1054, Page 7 of 33
`Slayback v. Eye Therapies - IPR2022-00142
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`

`

`Transcript of Robert O. Williams, III, Ph.D.
`November 15, 2022
`25
`
`7 (25 to 28)
`
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` A I do, yes.
` Q Okay. And you -- your comments on
`Pasquali -- let's take a step back. Let's -- if
`we could take -- if you could take a look at
`Exhibit 1025, 1025, if you have that in front of
`you.
` (Deposition Exhibit 1025 marked for
`identification.)
` A Okay. I do, yes.
`BY MS. CIPRIANO:
` Q Okay. You know that the Pasquali paper
`reported that patients who received the
`brimonidine solution used or the
`naphazoline/pheniramine were markably -- markedly
`more comfortable and less symptomatic than those
`that received control. Do you recall that?
` MS. CIPRIANO: Caitlin, we couldn't hear
`you. I'm sorry.
` MS. O'CONNELL: Objection to the extent it
`mischaracterizes the document.
` A Yeah. So I -- I cite in my paragraph
`72 -- I mean, I quote that from Pasquali. So
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`will say in this proceeding. Do you recall that?
` A Yes.
` Q And when you make those statements, you're
`not offering independent opinions on what those
`other experts will say, correct?
` MS. O'CONNELL: Objection, vague.
` A Well, I mean, I'd have to go kind of
`statement by statement, but if I have said another
`expert, you know, has a certain opinion, unless I
`add an opinion to that, I'm relying on that
`particular expert.
`BY MS. CIPRIANO:
` Q Understood. Okay. You provide some
`opinions in your declaration regarding about --
`regarding what the term "about" means in the
`context of the '742 patent. Do you recall that?
` A Yes.
` Q And for that opinion one of the things you
`rely on is what you call the typical acceptance
`criteria for FDA submissions, right?
` A As an example of a practical relevant use
`of the plus or minus 10 percent, yes, I do discuss
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`that's literally what Pasquali says.
`BY MS. CIPRIANO:
` Q Okay. And then -- so later in
`paragraph 72 of your declaration you provide an
`opinion that the difference between the drug
`formulations tested and the control tested in
`Pasquali may have been due to the pH of the
`solution, right?
` A I mean, I make that observation as a
`formulation scientist, with the understanding that
`0
`an acidic pH from -- my understanding from
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`Dr. Noecker that acidic pH, that those solutions
`12
`can cause burning, stinging, a discomfort of the
`13
`eye. So as a formulator, I do make that
`14
`observation, yes.
`15
` Q Did you look up the pHs of the solutions
`16
`used in the Pasquali paper?
`17
` A Well, Pasquali says that it's a -- it's a
`18
`diluted .1 percent brimonidine solution diluted to
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`.025 percent. And, you know, based on my
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`understanding from Dr. Noecker, that the .1
`21
`percent product that was on the market was one of
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`that.
` Q Are you aware of any FDA regulations that
`require all acceptance criteria to be within the
`range of 90 to 110 percent?
` MS. O'CONNELL: Objection, vague.
` A I'm not. And I didn't -- you know, in my
`declaration, I meant that as an example of a
`typical -- from my experience, 90 -- plus or minus
`10 percent the 90 to 110 percent is -- I mean,
`that is -- for shelf life stability, that is
`probably the range that I'm -- I've most been
`encountered with throughout my career. But I
`didn't say, yeah, that it's -- there's an FDA
`guidance that says it's that way in all cases.
`BY MS. CIPRIANO:
` Q So I'd like to turn to paragraph 70 of
`your declaration.
` A Okay.
` Q And the article that you're talking about
`in this section of your declaration is what we've
`referred to as the Pasquali paper. Do you see
`that?
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`Slayback Exhibit 1054, Page 8 of 33
`Slayback v. Eye Therapies - IPR2022-00142
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`

`

`8 (29 to 32)
`
`31
`
`Transcript of Robert O. Williams, III, Ph.D.
`November 15, 2022
`29
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`the Alphagan products at the time, that -- and
`based on my experience with, you know, developing
`and publishing in this field, that it's likely
`that that .1 percent brimonidine solution that was
`used compounded dilute solution, I'd say it was
`likely the Alphagan .1 percent product.
` Q Did you look up the pHs of the other
`solutions used in the Pasquali study?
` A Which -- the -- which other solutions?
`Sorry.
` Q Sure. So in your declaration you note
`that the burning and stinging that was seen more
`in the control than the brimonidine group could
`have been due to the pH. Do you recall that?
` A Yes.
` Q Okay. If we can take a look at page 2 of
`Exhibit 1025, the Pasquali paper.
` A Okay.
` Q At the very bottom of the left-hand
`column, this is in the Patients and Methods,
`section, there's a paragraph that starts
`Brimonidine tartrate. Do you see that?
`
`used as a control, correct?
` A That's my understanding.
` Q Okay. Do you know the pH of Systane
`Ultra?
` A I do not, no.
` Q Okay.
` A I don't.
` Q So if there was no difference in pH
`between the brimonidine formulation and the
`Systane Ultra formulation, the difference in
`comfort that Pasquali observed could not have been
`due to pH, right?
` MS. O'CONNELL: Objection, incomplete
`hypothetical, calls for speculation.
` A I mean, the Systane Ultra, it's like an
`artifical tear formulation. So it has two -- it
`has a polyethylene glycol, a polymer, and then
`propylene glycol. So those are two different
`liquid solvents with -- with some aqueous phase,
`but I don't -- I mean, I would have to ask a
`clinician about the -- interpreting the clinical,
`you know, results of this test. As a formulator,
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`I would have to ask the clinician.
` A Yes.
`BY MS. CIPRIANO:
` Q And then it goes on -- sorry. It says
` Q Okay. So your statements that the -- now
`that the brimonidine tartrate ophthalmic
`I'm looking back at paragraph 72 of your
`solution .1 percent was compounded to 0.025
`declaration. In the middle of the paragraph on
`percent by an independent pharmacy, and it gives
`page 28 there, you say: Thus, in my opinion, a
`the specifics there. And then the next sentence:
`contributing factor to the lack of burning and
`Naphcon A (naphazoline hydrochloride 0.025
`pain upon administration of brimonidine may have
`percent, pheniramine maleate 0.3 percent; Alcon
`been the pH of the solution.
`Laboratories.
` Do you see that?
` Do you see that?
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` A Yes.
` A I do.
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` Q But you made that conclusion without
` Q Okay. So that Naphcon A was the other
`12
`understanding any differences between the control
`test formulation that Pasquali compared
`13
`and the brimonidine formulation; is that right?
`brimonidine to, correct?
`14
` A Yes.
` MS. O'CONNELL: Objection,
`15
`mischaracterizes his report and testimony.
` Q Okay. And then that sentence goes on, and
`16
` A Well, here I'm saying that because the
`control. And then in paren it says: Systane
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`.1 percent brimonidine solution was used to
`Ultra, polyethylene glycol 400 0.4 percent,
`18
`compound the .025 percent brimonidine diluted
`propylene glycol 0.3 percent; Alcon Laboratories.
`19
`solution, that the .1 percent, what was on the
` Do you see that?
`20
` A Yes.
`market, was -- that was an example of one of the
`21
`Alphagan -- Alphagan products, and that Alphagan
` Q Okay. So the Systane Ultra product was
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`Slayback Exhibit 1054, Page 9 of 33
`Slayback v. Eye Therapies - IPR2022-00142
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`

`

`Transcript of Robert O. Williams, III, Ph.D.
`November 15, 2022
`33
`product had a higher pH value for the Alphagan .1
`percent. And so my rationale for that statement
`is that, you know, it didn't have an acidic pH,
`and so that -- from a formulator standpoint, that
`seems to jibe or agree with the -- with the
`results that they said for the brimonidine --
`dilute brimonidine solution with regards to
`irritation, burning, stinging.
`BY MS. CIPRIANO:
` Q Your statement is comparing the Alphagan P
`pH to the Alphagan original pH in terms of burning
`and stinging?
` A Sorry, I didn't understand your question.
` Q I'm just trying to understand the point
`that you are trying to make in paragraph 72.
`Pasquali makes a statement comparing the two test
`formulations in his study, brimonidine and the
`Naphcon A combination. And he compares that to
`control. And he makes the statement that there
`was less burning and stinging, more comfortable in
`the test formulations as compared to control.
` I'm trying to understand your position
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`towards the physiological pH of the lacrimal
`fluids.
` And so my understanding from Dr. Noecker,
`the clinician, is that that should be less
`irritating, at least irritating from a pH
`standpoint, acidic versus closer to the neutral pH
`that's physiological. That's my point there.
` Q Okay. Do you know what the pH of
`Naphcon A is?
` A I do -- I don't off the top of my head,
`no.
` Q Would it surprise you if it had an acidic
`pH?
` A I actually don't know. Yeah. And my
`point here was not with Naphcon. It was really
`with the .1 percent brimonidine and compared back
`to the Derick paper that I discussed earlier in my
`declaration that used a more acidic pH form of
`brimonidine. So that was -- this is the
`difference I'm drawing here. Sorry, in -- I'm
`rambling, but I don't know the pH of the Naphcon.
` Q Okay. Can you turn to paragraph 97 of
`
`9 (33 to 36)
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`that that was due to pH. And I -- and I am -- are
`your declaration.
`you commenting on Pasquali's conclusions?
` A Okay.
` A Well, no. I -- so what I'm doing here
` Q So in paragraph 97 you talk about a
`is -- so Pasquali uses this -- it starts with this
`progression in the art. Do you see that?
`.1 percent brimonidine solution. I make the
` A Yes.
`argument that -- I mean, what I'm saying is, when
` Q And as I understand it, your position is
`I read that, you know, as a skilled person, it
`that this progression in the art was a result of
`makes sense to me that that would be a product
`Allergan discounting Alphagan in favor of its
`that is commercially available to a pharmacy or to
`Alphagan