Laksar, Paul - Vol. 2
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`Case IPR2022-00142
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`January 18, 2023
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`1
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` UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE
` _______________________________________________X
` THE PATENT TRIAL AND APPEAL BOARD
` _______________________________________________X
` SLAYBACK PHARMA LLC,
` Petitioner
` vs.
` EYE THERAPIES, LLC,
` Patent Owner
` _______________________________________________X
` Case No. IPR2022-00142
` United States Patent No. 8,293,742
`
` ZOOM DEPOSITION OF PAUL A. LASKAR, Ph.D.
` Wednesday, January 18, 2023
`
`BEFORE:
`Gail Verbano:
` Registered Diplomate Reporter
` Certified Realtime Reporter
` Certified Shorthand Reporter
`
`202-220-4158
`
`Henderson Legal Services, Inc.
`www.hendersonlegalservices.com
`
`Eye Therapies Exhibit 2212, Page 1 of 181
`Slayback v. Eye Therapies - IPR 2022-00142
`
`
`
`Case IPR2022-00142
`
`January 18, 2023
`
`1
`
` UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE
` _______________________________________________X
` THE PATENT TRIAL AND APPEAL BOARD
` _______________________________________________X
` SLAYBACK PHARMA LLC,
` Petitioner
` vs.
` EYE THERAPIES, LLC,
` Patent Owner
` _______________________________________________X
` Case No. IPR2022-00142
` United States Patent No. 8,293,742
`
` ZOOM DEPOSITION OF PAUL A. LASKAR, Ph.D.
` Wednesday, January 18, 2023
`
`BEFORE:
`Gail Verbano:
` Registered Diplomate Reporter
` Certified Realtime Reporter
` Certified Shorthand Reporter
`
`202-220-4158
`
`Henderson Legal Services, Inc.
`www.hendersonlegalservices.com
`
`Eye Therapies Exhibit 2212, Page 1 of 181
`Slayback v. Eye Therapies - IPR 2022-00142
`
`
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`Laksar, Paul - Vol. 2
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`Case IPR2022-00142
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`January 18, 2023
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`2
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` Remote videotaped deposition of PAUL
`A. LASKAR, PH.D., held on Wednesday, January 18,
`2023, beginning at approximately 9:12 a.m., the
`proceedings being recorded stenographically by Gail
`Verbano, Registered Diplomate Reporter, Certified
`Realtime Reporter, Certified Shorthand Reporter,
`and transcribed under her direction.
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`202-220-4158
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`Henderson Legal Services, Inc.
`www.hendersonlegalservices.com
`
`Eye Therapies Exhibit 2212, Page 2 of 181
`Slayback v. Eye Therapies - IPR 2022-00142
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`Laksar, Paul - Vol. 2
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`Case IPR2022-00142
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`January 18, 2023
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` A P P E A R A N C E S
`
`On behalf of Petitioner:
` LINNEA P. CIPRIANO, ESQ.
` lcipriano@goodwinlaw.com
` DENISE GO, ESQ.
` dgo@goodwinlaw.com
` GOODWIN PROCTER LLP
` The New York Times Building
` 620 Eighth Avenue
` New York, New York 10018:
` 212.459.7528
`
`On behalf of Patent Owner:
` JUSTIN J. HASFORD, ESQ.
` justin.hasford@finnegan.com
` CHRISTINA YANG, ESQ.
` christina.yang@finnegan.com
` FINNEGAN, HENDERSON, FARABOW, GARRETT & DUNNER, LLP
` 901 New York Avenue, NW
` Washington, DC 20001-4413
` 202.408.4000
`
`ALSO PRESENT:
` ERIC VAVRASEK, Legal Videographer
` KRISTI McINTYRE, ESQ., Bausch + Lomb
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`202-220-4158
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`www.hendersonlegalservices.com
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`Eye Therapies Exhibit 2212, Page 3 of 181
`Slayback v. Eye Therapies - IPR 2022-00142
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`Laksar, Paul - Vol. 2
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`Case IPR2022-00142
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`January 18, 2023
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` C O N T E N T S
`EXAMINATION OF: PAGE
`PAUL A. LASKAR, Ph.D.
` By Attorney Hasford . . . . . . . . .7
` By Attorney Cipriano . . . . . . . .145
`
` E X H I B I T S
`LASKAR PAGE
`Exhibit 5 Article, "Alphagan allergy . . . .103
` may increase the propensity
` for multiple eye-drop
` allergy" (9 pages)
`Exhibit 6 United States Patent . . . . . . .113
` Application Publication
` Number US 2005/0266089
` (9 pages)
`Exhibit 7 Excerpts from "Understanding . . .125
` General Chemistry" (7 pages)
`Exhibit 8 Excerpts from "The Practice . . . .132
` of Chemistry" (9 pages)
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`202-220-4158
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`Henderson Legal Services, Inc.
`www.hendersonlegalservices.com
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`Eye Therapies Exhibit 2212, Page 4 of 181
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`Case IPR2022-00142
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`January 18, 2023
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`PREVIOUSLY MARKED EXHIBITS REFERENCED: PAGE
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` 1061 . . . . . . . . . . . . . . .105
` 2007 . . . . . . . . . . . . . . .115
` 2012 . . . . . . . . . . . . . . .135
` 2014 . . . . . . . . . . . . . . .139
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`202-220-4158
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`www.hendersonlegalservices.com
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`Eye Therapies Exhibit 2212, Page 5 of 181
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`Case IPR2022-00142
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`January 18, 2023
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` Wednesday, January 18, 2023; 9:12 a.m.
` - -
` THE VIDEOGRAPHER: Here begins
`Disk 1 in the video deposition of Paul A. Laskar,
`Ph.D., taken in the matter of Slayback Pharma
`LLC, V. Eye Therapies, LLC, in the United States
`Patent and Trademark Office before the Patent
`Trial and Appeal Board, Case Number
`IPR 2022-00142.
` Today's date is January 18th, 2023.
`The time on the video monitor is 9:12 a.m. Eastern
`Standard Time.
` This deposition is being held
`remotely via Zoom videoconference.
` The court reporter is Gail Verbano on
`behalf of Henderson Legal Services. The video
`camera operator is Eric Vavrasek, also on behalf of
`Henderson Legal Services.
` Will counsel please introduce
`themselves and state whom they represent, beginning
`with the party noticing the deposition.
` ATTORNEY HASFORD: Good morning.
`This is Justin Hasford from Finnegan, representing
`Patent Owner. I'm here with my co-counsel,
`Christina Yang, also from Finnegan, on behalf of
`
`202-220-4158
`
`Henderson Legal Services, Inc.
`www.hendersonlegalservices.com
`
`Eye Therapies Exhibit 2212, Page 6 of 181
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`Laksar, Paul - Vol. 2
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`Case IPR2022-00142
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`January 18, 2023
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`Patent Owner. And joining us is Kristi McIntyre,
`in-house counsel at Bausch.
` ATTORNEY CIPRIANO: Good morning.
`This is Linnea Cipriano of Goodwin, representing
`petitioner and the witness. With me as well is
`Denise Go also of Goodwin.
` THE VIDEOGRAPHER: Will the court
`reporter please swear in the witness.
` - - -
` PAUL A. LASKAR, Ph.D.,
` after being duly sworn or affirmed to testify to
` the truth, was examined and testified as follows:
` - - -
` ATTORNEY HASFORD: Let the record
`reflect that we hereby invoke the Rule on
`Witnesses pursuant to Federal Rule of Evidence
`615.
` EXAMINATION
`BY ATTORNEY HASFORD:
` Q. Good morning, Doctor.
` A. Good morning.
` Q. Would you please state your name and
`address for the record.
` A. Certainly. My name is Paul Laskar.
`I reside at 603 Montecito Boulevard, Napa,
`
`202-220-4158
`
`Henderson Legal Services, Inc.
`www.hendersonlegalservices.com
`
`Eye Therapies Exhibit 2212, Page 7 of 181
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`Case IPR2022-00142
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`January 18, 2023
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`California.
` Q. Doctor, I represent the Patent Owner
`in these IPR proceedings. Today I will ask you
`questions, and I would ask that you answer my
`questions truthfully and accurately.
` If you need a break, just let me
`know. But if a question is pending, please first
`answer the question, and then we can take a break.
` If for any reason you do not
`understand a question that I ask, please let me
`know. If you answer a question, I will assume that
`you understood the question.
` Is that okay?
` A. Yes, that's okay.
` Q. Is there reason -- any reason why
`you cannot testify truthfully and accurately
`today?
` A. No, there is no reason.
` ATTORNEY HASFORD: Let's turn up
`Exhibit 1048 in IPR 2022-00142. It is entitled
`"Declaration of Paul Laskar, Ph.D., In Support of
`Petitioner's Reply."
`BY ATTORNEY HASFORD:
` Q. Do you have a copy of that, Doctor?
` A. Yes, I do.
`
`202-220-4158
`
`Henderson Legal Services, Inc.
`www.hendersonlegalservices.com
`
`Eye Therapies Exhibit 2212, Page 8 of 181
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`Case IPR2022-00142
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`January 18, 2023
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` Q. Is Exhibit 1048 in IPR 2022-00142,
`your declaration -- your reply declaration, that
`is -- concerning U.S. Patent No. 8,293,742?
` A. I'm -- I'm sorry. Was there a
`question?
` Q. Sure. I'll -- I'll repeat it for
`you.
` Is Exhibit 1048 in IPR 2022-00142
`your reply declaration concerning U.S. Patent
`No. 8,293,742?
` A. Yes, it is.
` Q. If I refer to U.S. Patent
`No. 8,293,742 as "the '742 patent," will you
`understand what I mean?
` A. Yes, I will.
` Q. You are not an FDA regulatory
`expert; correct?
` A. No, I'm not an FDA regulatory expert
`but --
` Q. You did not conduct any testing in
`connection with your opinions in this case;
`correct?
` A. I have not conducted any independent
`testing concerning my opinions in this case.
` Q. With respect to the '742 patent, you
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`202-220-4158
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`Henderson Legal Services, Inc.
`www.hendersonlegalservices.com
`
`Eye Therapies Exhibit 2212, Page 9 of 181
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`did not provide any specific opinions regarding
`the interaction of tolerability, solubility,
`stability, and permeability; correct?
` ATTORNEY CIPRIANO: Objection to
`form.
` THE WITNESS: Could you repeat the
`question, please.
`BY ATTORNEY HASFORD:
` Q. Certainly.
` With respect to the '742 patent, you
`did not provide any specific opinions regarding the
`interaction of tolerability, solubility, stability,
`and permeability; correct?
` ATTORNEY CIPRIANO: Same objection.
` THE WITNESS: I have provided
`information and -- and opinions concerning the
`active ingredient brimonidine tartrate as it would
`relate to the matter covered by the '742 patent.
`BY ATTORNEY HASFORD:
` Q. Let me ask the question again, and
`let me -- you -- you understand the concepts of
`tolerability, solubility, stability, and
`permeability? You understand those four concepts;
`correct?
` A. Yes, I do understand those concepts.
`
`202-220-4158
`
`Henderson Legal Services, Inc.
`www.hendersonlegalservices.com
`
`Eye Therapies Exhibit 2212, Page 10 of 181
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` Q. Okay. Then I'll ask the question
`again.
` With respect to the '742 patent, you
`did not provide any specific opinions regarding the
`interaction of tolerability, solubility, stability,
`and permeability; correct?
` ATTORNEY CIPRIANO: Objection to
`form.
` THE WITNESS: I -- I have provided
`opinions relative to stability, permeability, and
`solubility of brimonidine tartrate that overlay
`the -- the material described in the specification
`for the '742 patent.
`BY ATTORNEY HASFORD:
` Q. You mentioned solubility, stability,
`and permeability. Why do you not provide any
`opinions with respect to the '742 patent on
`tolerability?
` A. As a -- as a nonclinician, that
`would be beyond the scope of -- of my expertise.
`I do understand the concept; however, I have no
`firsthand experience with respect to measuring it.
` Q. You would agree that an indication
`for use may impact formulation development of an
`ophthalmic solution; correct?
`
`202-220-4158
`
`Henderson Legal Services, Inc.
`www.hendersonlegalservices.com
`
`Eye Therapies Exhibit 2212, Page 11 of 181
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` A. The indication for use of a compound
`could influence the route of -- taken to achieve a
`formulation.
` Q. You would agree that a proposed
`duration of use may impact formulation development
`of an ophthalmic solution; correct?
` A. Could you define "duration of use"
`for me, please.
` Q. What's your understanding of
`"duration of use"?
` A. I can understand it to mean the time
`period over which the -- the drug product might be
`used.
` Q. So I'm just asking you based on your
`understanding. So I'll ask the question again.
` ATTORNEY CIPRIANO: Objection. If
`you can let the -- the witness finish, please.
`BY ATTORNEY HASFORD:
` Q. You would -- you would agree --
` A. I -- I was not -- I was not done,
`sorry, sir.
` Duration does -- can mean other
`things relative to the use of pharmaceuticals, but
`the most prevalent would be the -- the time
`duration of therapy -- that the therapy is
`
`202-220-4158
`
`Henderson Legal Services, Inc.
`www.hendersonlegalservices.com
`
`Eye Therapies Exhibit 2212, Page 12 of 181
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`employed.
` Q. Okay. And -- and I think your
`understanding the time period over which the drug
`product might be used, that was what I was trying
`to get at. So let me ask the question again.
` You would agree that a proposed
`duration of use may impact formulation development
`of an ophthalmic solution; correct?
` A. It is one of the attributes that a
`formulator considers in developing formulation.
` Q. A product for one-time use may not
`need to be as comfortable as a product for
`everyday use; correct?
` A. And that is a -- true as a
`generality, that the -- the adherence, as -- as it
`might be described of a patient to the therapy can
`be influenced by such perception as tolerability
`and -- and comfort.
` Q. One commercial reason for
`discontinuing an eye drop product is that it is
`not well received by patients or doctors; correct?
` A. Could you define "well received" in
`this context.
` Q. What -- what's your understanding of
`a product being "well received"?
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`202-220-4158
`
`Henderson Legal Services, Inc.
`www.hendersonlegalservices.com
`
`Eye Therapies Exhibit 2212, Page 13 of 181
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` A. I -- I -- there are -- there are
`multiple definitions that I could apply to that --
`to that term in that question.
` Q. Okay. Let me ask --
` A. I'd like to -- I'd like to
`understand yours in the context of the question so
`I can answer appropriately.
` Q. Do -- do you have an understanding
`of what it means for a product to be "well
`received" by a patient or a physician?
` A. I -- I have -- I think I would say I
`would have more than one.
` Q. What's your first understanding?
` A. Well received by a physician might
`be that he is willing to use it frequently.
` Q. I'll -- I'll accept your
`understanding.
` One commercial reason for
`discontinuing an eye drop product is that it is not
`well received by a physician; correct?
` A. And it -- and it could be non- --
`not well received for multiple reasons; yes,
`that's correct.
` Q. One commercial reason for
`discontinuing an eye drop product is that it is
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`202-220-4158
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`Henderson Legal Services, Inc.
`www.hendersonlegalservices.com
`
`Eye Therapies Exhibit 2212, Page 14 of 181
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`not well received by patients for multiple
`reasons; correct?
` A. There are multiple reasons,
`including -- including price, accessibility, among
`others.
` Q. What others?
` A. What others?
` That might -- in addition to
`accessibility and price, convenience of use. It
`might include, I would call them adverse effects
`following use, such as blurring upon
`administration. It might -- it might include the
`duration of any stinging or other discomfort
`following use.
` Q. An eye drop product may not be well
`received by patients or physicians because of lack
`of comfort; correct?
` A. As I said, that is one aspect.
` Q. Another commercial reason for
`discontinuing an eye drop product could be that a
`more comfortable, equally efficacious product is
`available; correct?
` A. That is -- that is a possibility,
`certainly.
` Q. Let's take a look at your reply
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`202-220-4158
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`Henderson Legal Services, Inc.
`www.hendersonlegalservices.com
`
`Eye Therapies Exhibit 2212, Page 15 of 181
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`declaration. Turn, if you would, to page 6.
` A. I'm there.
` Q. And I'm going to direct your
`attention to paragraph 8, it begins on -- it
`begins on page 5 -- actually, why don't you take a
`moment, review paragraph 8, and let me know when
`you're ready.
` A. Okay.
` (Witness reviews document.)
` A. Okay.
` Q. I want to direct your attention to
`the -- the sentence that begins at the bottom of
`page 5 with "Rather," and then -- then it goes to
`the top of page 6 and says, "acceptance criteria
`are used to define acceptable test result ranges
`to meet product quality and consistency standards
`during or after manufacturing."
` Do you see that?
` A. I do.
` Q. How are acceptance criteria used to
`define acceptable test result ranges to meet
`product quality and consistency standards during
`manufacturing?
` A. How are acceptance criteria used to
`define...?
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`202-220-4158
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`Henderson Legal Services, Inc.
`www.hendersonlegalservices.com
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`Eye Therapies Exhibit 2212, Page 16 of 181
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`Laksar, Paul - Vol. 2
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`Case IPR2022-00142
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`January 18, 2023
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` The -- they are used in -- in the
`context that -- during the -- that the
`manufacturing of a drug product results in some
`variability from -- between -- among batches
`manufactured, the analytical technologies
`associated with -- with various acceptance
`criteria have a -- some degree of precision or
`imprecision associated with them, all of which are
`factored into -- factored into the setting of an
`acceptance criteria.
` Q. Why are acceptance criteria used to
`define acceptable test result ranges to meet
`product quality and consistency standards during
`manufacturing?
` A. Why are acceptance criteria used to
`define acceptable test result ranges to meet
`product quality and consistency standards during
`and after manufacture?
` They are used to determine -- or --
`or to ensure that -- I should say, that the
`product made time after time is done
`consistently -- is done so that the expectations
`that a clinician has for the therapeutic results
`and the patient has for treatment of their
`condition is reproducibly accomplished.
`
`202-220-4158
`
`Henderson Legal Services, Inc.
`www.hendersonlegalservices.com
`
`Eye Therapies Exhibit 2212, Page 17 of 181
`Slayback v. Eye Therapies - IPR 2022-00142
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`Case IPR2022-00142
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` Q. But let's now talk about after
`manufacturing. How are acceptance criteria used
`to define acceptable test result ranges to meet
`product quality and consistency standards after
`manufacturing?
` A. After -- after manufacturing is --
`as is the case with essentially all drugs the --
`there can be some decomposition of the active
`ingredient. There can be other changes, such as
`loss of water through the container, thereby
`changing some test parameters; and that the
`acceptance criteria for those test parameters need
`to be met not only during manufacture or
`immediately after manufacturing but throughout
`whatever the claimed shelf life of that product
`might be.
` Q. Why are acceptance criteria used to
`define acceptable test result ranges to meet
`product quality and consistency standards after
`manufacturing?
` A. The "why" would be that it -- that
`the -- the product must meet those in order to
`ensure that the product is efficacious and safe
`throughout its shelf life or lifespan.
` Q. Take a look, if you would now, at
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`202-220-4158
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`Henderson Legal Services, Inc.
`www.hendersonlegalservices.com
`
`Eye Therapies Exhibit 2212, Page 18 of 181
`Slayback v. Eye Therapies - IPR 2022-00142
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`Laksar, Paul - Vol. 2
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`Case IPR2022-00142
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`January 18, 2023
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`paragraph 9 on page 6 of your reply declaration.
` A. Uh-huh, I see it.
` Q. Why don't you review that paragraph,
`and let me know when you're ready.
` (Witness reviews document.)
` A. Okay. I've reviewed it.
` Q. Let me direct your attention to the
`second sentence where you say, "Many acceptance
`criteria are set at ± 10 percent."
` Do you see that?
` A. I do.
` Q. Why are many acceptance criteria set
`at ± 10 percent?
` ATTORNEY CIPRIANO: Objection; calls
`for speculation, scope.
` THE WITNESS: The setting of a
`± 10 percent is specific to the individual
`product; and the reasons why it is set for a
`particular individual product is -- is generated
`by the information about that product. And so I
`don't -- it's not a -- something about which I --
`I believe I could generalize and be accurate.
`BY ATTORNEY HASFORD:
` Q. Why is it important that many
`acceptance criteria are set at ± 10 percent?
`
`202-220-4158
`
`Henderson Legal Services, Inc.
`www.hendersonlegalservices.com
`
`Eye Therapies Exhibit 2212, Page 19 of 181
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`Laksar, Paul - Vol. 2
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`Case IPR2022-00142
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` ATTORNEY CIPRIANO: Same objections;
`calls for speculation, outside the scope of the
`reply.
` THE WITNESS: I -- I was not asked
`to opine on -- on the rationale.
`BY ATTORNEY HASFORD:
` Q. Approximately what percentage of
`acceptance criteria are set at ± 10 percent?
` ATTORNEY CIPRIANO: Objection;
`scope, foundation.
` THE WITNESS: I -- in -- in -- while
`I did not survey the entire database of drugs at
`FDA, I did look at those products that have USP
`monographs. And for those at one point in time I
`did take -- I did look to see what that number
`was; but I'm sorry that I don't recall it at this
`moment. It was -- and I did that for curiosity.
`BY ATTORNEY HASFORD:
` Q. Do you know one way or another
`approximately what percentage of acceptance
`criteria are set at ± 10 percent?
` A. Can you clarify that for me, please.
`What are you --
` Q. Do -- do --
` A. -- what scope of products are you
`
`202-220-4158
`
`Henderson Legal Services, Inc.
`www.hendersonlegalservices.com
`
`Eye Therapies Exhibit 2212, Page 20 of 181
`Slayback v. Eye Therapies - IPR 2022-00142
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`referring?
` Q. Let's -- let's take ophthalmic
`solutions.
` Approximately what percent of
`acceptance criteria for active ingredients for
`ophthalmic solutions are set at ± 10 percent?
` ATTORNEY CIPRIANO: Objection;
`scope.
` THE WITNESS: I -- I can't answer
`that question, because I don't know the database
`upon which you were asking the opinion.
`BY ATTORNEY HASFORD:
` Q. Take a look at the last sentence in
`paragraph 9 of your reply report.
` A. I see that.
` Q. In terms of plus or minus allowable
`percent, what is a minimum FDA acceptance criteria
`for an active pharmaceutical ingredient?
` ATTORNEY CIPRIANO: Objection;
`scope.
` THE WITNESS: Minimum acceptance,
`that would -- you say the lowest percentage of
`label claim? Is that --
`BY ATTORNEY HASFORD:
` Q. Correct.
`
`202-220-4158
`
`Henderson Legal Services, Inc.
`www.hendersonlegalservices.com
`
`Eye Therapies Exhibit 2212, Page 21 of 181
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`Laksar, Paul - Vol. 2
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`Case IPR2022-00142
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`January 18, 2023
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` A. I -- I don't recall. And I would --
`I would just add that I don't recall which of the
`U.S. -- of the products -- the ophthalmic solution
`products having USP monographs has the lowest
`percent label claim.
` Q. In terms of plus or minus allowable
`percent, what is the maximum FDA acceptance
`criteria for an active pharmaceutical ingredient?
` A. Same answer as I -- I -- I have -- I
`saw it. I don't recall it.
` Q. Okay. Do you -- do you know one way
`or another?
` ATTORNEY CIPRIANO: Objection; form.
` THE WITNESS: I'm sorry. One way or
`another --
`BY ATTORNEY HASFORD:
` Q. Do you -- do you know what that
`number is, one way or another?
` A. No, I don't. It's greater than
`110 percent. Beyond that, I -- I would be
`speculating.
` Q. Acceptance criteria for an
`ophthalmic solution depend on the active
`pharmaceutical ingredient used in the formulation;
`correct?
`
`202-220-4158
`
`Henderson Legal Services, Inc.
`www.hendersonlegalservices.com
`
`Eye Therapies Exhibit 2212, Page 22 of 181
`Slayback v. Eye Therapies - IPR 2022-00142
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`Laksar, Paul - Vol. 2
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`Case IPR2022-00142
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`January 18, 2023
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` ATTORNEY CIPRIANO: Objection; form.
` THE WITNESS: Yes, one attribute
`that impacts the -- the acceptance criteria for
`percent of label claim is the specific
`pharmacologic agent.
`BY ATTORNEY HASFORD:
` Q. But pharmaceutical formulations with
`different active pharmaceutical ingredients can
`have different acceptance criteria; correct?
` A. Yes, that would be the -- in essence
`the converse of what you said is that it's
`specific to a compound that -- so one compound
`will have one; another might have another.
` Q. You are familiar with the US
`Pharmacopeia; correct?
` A. Yes, I am.
` Q. If I refer to the US Pharmacopeia as
`the "USP," will you understand what I mean?
` A. Yes, I would.
` Q. And I may refer to it as the "US
`Pharmacopeia," but you understand those two to be
`the same thing; correct?
` A. Yes, they are synonymous.
` Q. You have relied upon the USP
`previously in your own work; correct?
`
`202-220-4158
`
`Henderson Legal Services, Inc.
`www.hendersonlegalservices.com
`
`Eye Therapies Exhibit 2212, Page 23 of 181
`Slayback v. Eye Therapies - IPR 2022-00142
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`Laksar, Paul - Vol. 2
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`Case IPR2022-00142
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`January 18, 2023
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` A. Yes, I have.
` Q. You are familiar with the USP
`acceptance criteria; correct?
` A. I have -- I have for particular
`compounds for particular products, yes, I am
`familiar with the acceptance criteria.
` Q. You have relied on USP acceptance
`criteria in your own work; correct?
` A. Yes, I believe that's what I said.
` Q. Drug product specifications from a
`manufacturer may be narrower than USP acceptance
`criteria; correct?
` ATTORNEY CIPRIANO: Objection; calls
`for speculation.
` THE WITNESS: It is a possibility,
`and something that a manufacturer might choose to
`do.
`BY ATTORNEY HASFORD:
` Q. Manufacturer drug product
`specifications should not be broader than USP
`acceptance criteria; correct?
` ATTORNEY CIPRIANO: Same objection.
` THE WITNESS: If the -- if the label
`claim specifications are -- are broader than those
`defined in the USP, then the product cannot be
`
`202-220-4158
`
`Henderson Legal Services, Inc.
`www.hendersonlegalservices.com
`
`Eye Therapies Exhibit 2212, Page 24 of 181
`Slayback v. Eye Therapies - IPR 2022-00142
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`Laksar, Paul - Vol. 2
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`Case IPR2022-00142
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`January 18, 2023
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`labeled as XYZ USP ophthalmic solution.
`BY ATTORNEY HASFORD:
` Q. Is it fair to say then that
`manufacturer drug specifications should not be
`broader than USP acceptance criteria?
` ATTORNEY CIPRIANO: Objection; calls
`for speculation, scope.
` THE WITNESS: That -- that I think
`is a decision made by the marketer of the product.
`There's no compulsion to -- if there is a USP
`monograph for a particular ophthalmic solution,
`there's no compulsion in and of itself to be
`labeled as USP.
`BY ATTORNEY HASFORD:
` Q. Is there a good reason to be
`labeled --
` A. It --
` Q. -- as USP?
` A. I would -- yes, in my opinion, there
`is an advantage.
` Q. You have reviewed the '742 patent in
`connection with this proceeding; correct?
` A. Yes, I have reviewed the '742
`patent.
` Q. In connection with your opinions in
`
`202-220-4158
`
`Henderson Legal Services, Inc.
`www.hendersonlegalservices.com
`
`Eye Therapies Exhibit 2212, Page 25 of 181
`Slayback v. Eye Therapies - IPR 2022-00142
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`
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`Laksar, Paul - Vol. 2
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`Case IPR2022-00142
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`January 18, 2023
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`this case you proposed a definition of a person of
`ordinary skill in the art of the '742 patent;
`correct?
` A. Yes, I have proposed a definition of
`a POSA.
` Q. Would a person of ordinary skill in
`the art of the '742 patent have an understanding
`of USP acceptance criteria?
` A. Yes, I -- I certainly believe they
`would.
` Q. The '742 patent does not --
`[inaudible] the use of the USP for determining
`acceptance criteria for brimonidine; correct?
` ATTORNEY CIPRIANO: Objection to
`form.
` (Interruption by the court reporter
` to clarify the record.)
` ATTORNEY HASFORD: Sure. I can
`repeat it.
`BY ATTORNEY HASFORD:
` Q. The '742 patent does not preclude
`the use of the USP for determining acceptance
`criteria for brimonidine; correct?
` A. I would just point out there is no
`USP monograph for brimonidine.
`
`202-220-4158
`
`Henderson Legal Services, Inc.
`www.hendersonlegalservices.com
`
`Eye Therapies Exhibit 2212, Page 26 of 181
`Slayback v. Eye Therapies - IPR 2022-00142
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`Laksar, Paul - Vol. 2
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`Case IPR2022-00142
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`January 18, 2023
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` Q. That -- that wasn't my question,
`though.
` The -- the '742 patent does not
`preclude the use of the USP for determining
`acceptance criteria; correct?
` A. I'm at a loss to understand how --
`in the absence of a USP monograph for brimonidine,
`how it can be applied.
` Q. Again, that wasn't my question.
`I'll ask it differently.
` Does the '742 patent or does it not
`preclude the use of the USP for determining
`acceptance criteria?
` ATTORNEY CIPRIANO: Objection; asked
`and answered.
` THE WITNESS: Again, I -- in the
`absence of a brimonidine USP monograph, the USP is
`silent in describing, defining, or prescribing
`label claim limits for brimonidine as reflected in
`the '742 patent.
`BY ATTORNEY HASFORD:
` Q. Let me -- let me ask it differently
`then with -- and -- and I'll -- I won't reference
`brimonidine in the question.
` The '742 patent does not preclude the
`
`202-220-4158
`
`Henderson Legal Services, Inc.
`www.hendersonlegalservices.com
`
`Eye Therapies Exhibit 2212, Page 27 of 181
`Slayback v. Eye Therapies - IPR 2022-00142
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`Case IPR2022-00142
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`January 18, 2023
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`use of the USP for determining acceptance
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