Transcript of the Testimony of Ivan T. Hofmann
`
`Date: March 25, 2016
`
`Case: Innpharma Licensing, Inc., et al. v. Senju Pharmaceutical Co.,
`LTD., et al.
`
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`SENJU EXHIBIT 2273
`INNOPHARMA v. SENJU
`IPR2015-00902
`
`
`
`Date: March 25, 2016
`
`Case: Innpharma Licensing, Inc., et al. v. Senju Pharmaceutical Co.,
`LTD., et al.
`
`THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION
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`SENJU EXHIBIT 2273
`INNOPHARMA v. SENJU
`IPR2015-00902
`
`
`
`Ivan T. Hofmann - March 25, 2016
`THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION
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` UNITED STATES PATENT AND TRADEMARK OFFICE
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
`- - - - - - - - - - - - - - - - - - - - - - -X
`INNOPHARMA LICENSING INC., INNOPHARMA LICENSING LLC,
` INNOPHARMA INC., INNOPHAMA LLC,
` MYLAN PHARMACEUTICALS INC., and MYLAN INC.,
` Petitioner
` v.
`SENJU PHARMACEUTICAL CO., LTD., BAUSCH & LOMB, INC.
` and BAUSCH & LOMB PHARMA HOLDINGS CORP.
` Patent Owner
` Case IPR2015-00902 (Patent 8,669,290 B2)
` Case IPR2015-00903 (Patent 8,129,431 B2)
`
`- - - - - - - - - - - - - - - - - - - - - - X
` CONFIDENTIAL
` DEPOSITION of IVAN T. HOFMANN, CPA/CFF, CLP,
`taken pursuant to Notice, held at the law offices of
`ALSTON & BIRD, LLP, 90 Park Avenue, 15th Floor, New
`York, New York, 10016-1387, on Friday, March 25,
`2016, at 10:00 a.m., before JEANNETTE MCCORMICK, a
`Certified Shorthand Reporter, and a Notary Public.
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`Ivan T. Hofmann - March 25, 2016
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`A P P E A R A N C E S:
`
`Page 2
`
` FINNEGAN, HENDERSON, FARABOW, GARRETT
` & DUNNER, LLP
` Attorneys for Patent Owner
` 901 New York Avenue, N.W.
` Washington, D.C. 20001-4413
` BY: BRYAN C. DINER, ESQ.
` (202) 408-4000 (Telephone)
` (202) 408-4400 (Fax)
` bryan.diner@finnegan.com
`
` ALSTON & BIRD, LLP
` Attorneys for Petitioner
` Bank of America Plaza
` 101 South Tyron Street, Suite 4000
` Charlotte, North Carolina 28280-4000 USA
` BY: JOSEPH M. JANUSZ, ESQ.
` (704) 444-1000 (Telephone)
` (704) 444-1738 (Fax)
` joe.janusz@alston.com
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`Ivan T. Hofmann - March 25, 2016
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`Also Present:
` Savanna Stack (Finnegan Henderson)
` Thomas Del Vecchio (Videographer)
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`Ivan T. Hofmann - March 25, 2016
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` I N D E X
`WITNESS EXAMINATION BY PAGE
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`Page 4
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`IVAN T. HOFMANN
` MR. DINER 10
`
` E X H I B I T S
`
`NUMBER DESCRIPTION PAGE
`InnoPharma Confidential
`Exhibit 1150 Declaration of Ivan T.
` Hofmann, CPA/CFF, CLP 11
`
`InnoPharma
`Exhibit 1001 U.S. Patent 8,129,431 B2 17
`
`InnoPharma
`Exhibit 1004 U.S. Patent 4,910,225
` Ogawa, et al 21
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` I N D E X
` (CONTINUED)
` E X H I B I T S
`NUMBER DESCRIPTION PAGE
` Confidential
`Exhibit 2130 Declaration of John C.
` Jarosz 29
`
`Exhibit 2271 Petitioner's Reply to
` Patent Owner's Response
` to Petition (Paper No. 51)
`56
`
`Exhibit 2221 "Selecting an NSAID for
` Cataract Surgery: What
` Really Matters," Mitchell
` A. Jackson, M.D.
` Bates Nos. PROL0280722 - 48 106
`Exhibit 2227 Abstract, B&L Integrated
` Phase III Clinical Trials
` of Low-Concentration,
` Bates Nos. PROL0284927 149
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` I N D E X
` (CONTINUED)
` E X H I B I T S
`NUMBER DESCRIPTION PAGE
`Exhibit 2223 Abstract, B&L 24-Hour
` Evaluation of Ocular
` Pharmacokinetics of
` 14 C-Labeled Low-Concentration
` Bates Nos. PROL0280755 160
`
`Exhibit 2217 "Introducing Prolensa"
` Bates Nos. PROL0280370 - 71 170
`Exhibit 2220 Prolensa 0.07%
` Bates Nos. PROL0280685 - 702 182
`InnoPharma
`Exhibit 1151 24-Hour Evaluation of the
` Ocular Distribution of
` 14C-Labeled Bromfenac
` Following Topical
` Instillation into the Eyes
` of New Zealand White Rabbits
` Bates Nos. PROL0167067 - 73 198
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` I N D E X
` (CONTINUED)
` E X H I B I T S
`NUMBER DESCRIPTION PAGE
`Exhibit 2228 Bromfenac Ophthalmic Solution
` 0.07% Dosed Once Daily for
` Cataract Surgery (9 pages) 204
`Exhibit 2226 Cataract Discussion Groups
` Bates Nos. PROL0280867 - 93 214
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` THE VIDEOGRAPHER: Good morning. We are
` now on the record. Please note that the
` microphones are sensitive and may pick up
` whispering and private conversations. Please
` turn off all cell phones or place them away
` from the microphones as they may interfere
` with the deposition audio. Recording will
` continue until parties agree to go off the
` record.
` This is the deposition of Mr. Ivan T.
` Hofmann in the matter of InnoPharma
` Licensing, Inc., et al, Petitioner, versus
` Senju Pharmaceutical Co., Ltd., et al, Patent
` Owners, Case Numbers 1 -- I'm sorry -- I
` think it's IPR2015-00902 (Patent No.
` 8,669,290 B2), also IPR2015-00903 (Patent No.
` 8,129,431 B2) in the United States Patent and
` Trademark Office Before the Patent Trial and
` Appeals Board.
` This deposition is being taken at the
` office of Alston & Bird, 90 Park Avenue, New
` York, New York, 10016.
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`Ivan T. Hofmann - March 25, 2016
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` The time is approximately 10:13 a.m.
` Today's date is Friday, March 25th, 2016.
` The court reporter today is Jeannette
` McCormick with the firm of Ace-Federal
` Reporters. I am the video operator, Thomas
` Del Vecchio, representing the firm of
` Ace-Federal Reporters, Inc., 1625 I Street,
` Northwest, Washington, D.C., 20006.
` Will counsel please identify themselves
` and who they represent.
` MR. DINER: Bryan Diner, counsel for
` plaintiffs, from the law firm of Finnegan
` Henderson, and with me is my colleague
` Savanna Stack also from Finnegan.
` MR. JANUSZ: Joe Janusz of Alston & Bird
` for Petitioners.
` THE VIDEOGRAPHER: Thank you. Now will
` the court reporter please swear in the
` witness.
`
` IVAN T. HOFMANN, CPA/CFF, CLP,
` having been first duly sworn
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`Ivan T. Hofmann - March 25, 2016
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` testified as follows:
`
`Page 10
`
` EXAMINATION
`BY MR. DINER:
` Q. Good morning, Mr. Hofmann. How are you
`today?
` A. Good. How are you, Mr. Diner?
` Q. I'm fine. Thank you.
` A. Good.
` Q. For the sake of formalities, will you please
`state your name and address for the record.
` A. Yeah. My name is Ivan T. Hofmann, and I live
`at 169 Southridge Drive, Cranbury Township,
`Pennsylvania, 16066.
` Q. Okay. I just --
` A. I assume you wanted my residential address?
` Q. That's fine.
` A. Okay.
` Q. And you have been deposed before correct,
`Mr. Hofmann?
` A. I have.
` Q. Any reason why you cannot testify truthfully
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`and accurately today?
` A. No, sir.
` THE VIDEOGRAPHER: Excuse me. Can you
` raise your microphone all the way up. Thank
` you.
`BY MR. DINER:
` Q. Mr. Hofmann, I'm handing you the first
`Exhibit Hofmann 1 which has been marked as Innopharma
`Exhibit 1150.
` Is this your declaration in this matter?
` A. It appears to be, yes.
` MR. JANUSZ: I just want to note, I
` don't know if it's true for all copies, but I
` think page 80, one of the exhibits in the
` back is missing. I believe it would be
` Exhibit D-1.
` MR. DINER: Oh, you're right.
` THE WITNESS: Actually, it seems to be
` pervasive issue in the copy. The page order
` skips a page. Now that I look at it more
` closely, I'm missing every other page. It
` seemed a little bit thin.
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` MR. DINER: Could we go off the record
` for a minute?
` MR. JANUSZ: Yes.
` THE VIDEOGRAPHER: The time is
` approximately 10:17 a.m. We're off the
` record.
` (Recess from 10:17 to 10:20.)
` THE VIDEOGRAPHER: The time is
` approximately 10:20 a.m. We're back on the
` record.
`BY MR. DINER:
` Q. Mr. Hofmann, do you consider yourself an
`expert in pharmacology?
` A. Not from any technical perspective. I
`certainly have expertise in the economics within the
`pharmaceutical industry though.
` Q. Okay. And you're not an expert in pharmacy
`from a technical perspective, correct?
` A. From a technical perspective, no. From the
`economics of the implications of distribution of
`pharmaceuticals I am.
` Q. Okay. And you're not a medical doctor; is
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`that correct?
` A. I'm not a medical doctor, no.
` Q. And you've never administered medication to a
`patient, correct?
` A. I have not.
` Q. As a licensed medical doctor, right?
` A. Correct. I guess I've given my daughter
`Tylenol.
` Q. And you've never administered any
`bromfenac-containing products to a patient, correct?
` A. No, sir.
` Q. Okay. And you have never done any research
`of a technical nature on a bromfenac product; is
`that correct?
` A. Not from a technical perspective, no.
` Q. And you've never conducted any research from
`a technical perspective on any product containing
`tyloxapol, correct?
` A. Again, not from a technical perspective, but
`certainly, obviously, in this case I have from an
`economic perspective.
` Q. And you're not an expert in formulating
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`pharmaceutical products, correct?
` A. Again, not a formulation expert from a
`technical perspective, but I've analyzed patent
`issues involving formulations and the economic
`implications therein on multiple occasions.
` Q. Okay. And neither are you an expert in the
`technical area of chemistry, right?
` A. I am not a technical expert in chemistry.
` Q. And I apologize if I've asked this question
`already, but you are not a pharmacist or an expert
`in pharmacy, correct?
` A. I think you did ask that. I think my
`response was I'm not a pharmacist from any sort of
`distribution of prescription pharmaceuticals from a,
`you know, complying with a prescription from a
`pharmacist as a pharmacist, but I certainly am
`well-versed in the issues, the economic issues, the
`implications of the distribution of prescription
`pharmaceutical products.
` Q. Okay. Now, in connection with your opinions
`in this case, did you consider U.S. Patent No.
`8,669,290?
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` A. Yes.
` Q. And in connection with your opinions in this
`case, did you consider Patent No. 8,129,431?
` A. Yes.
` Q. And if I refer to U.S. Patent No. 8,129,431
`as the '431 patent, will you understand what I mean?
` A. I will.
` Q. And, similarly, if I refer to U.S. Patent
`8,669,290 as the '290 patent, will you understand
`what I mean by that?
` A. I will.
` Q. Okay. Thank you. Now, in connection with
`your opinions in this case, did you consider the
`claims of the '290 and '431 patents?
` A. I did.
` Q. And is it your understanding of the claims of
`those patents that they contain -- strike that.
` Or is it your understanding of the claims of
`those patents that they claim aqueous liquid
`preparations containing at least bromfenac and
`tyloxapol?
` A. Right. They don't claim as novel the
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`compound bromfenac itself, but they do claim a
`formulation that contains bromfenac and tyloxapol.
` Q. And the claim of the patentees is that these
`claims that recite aqueous liquid preparations
`containing bromfenac and tyloxapol is that they are
`novel, correct?
` A. That's the claim.
` Q. So, is it fair to say that the patentees in
`this matter consider aqueous liquid pharmaceutical
`compositions containing bromfenac and tyloxapol as a
`unique aspect of their claimed invention?
` MR. JANUSZ: Objection to scope, and
` calls for speculation.
` THE WITNESS: I mean, when you get into
` formulation and the technical aspects of the
` particular claims, I would defer to technical
` experts, but my understanding in forming my
` opinions is that the asserted claims do
` include what you described.
` Q. And what I described is the novel aspect of
`those claims as considered by the patent -- by
`patent owners here to be bromfenac in combination
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`with tyloxapol, correct?
` MR. JANUSZ: Same objection.
` THE WITNESS: Well, I mean, again, I'd
` defer to technical experts. I think there's
` great dispute over whether there's novelty to
` those claims, but yes, they -- the patentee
` claims that that combination and aqueous
` dosage form is novel.
` Q. Okay. And in connection with your opinions
`in this case, did you happen to observe that some of
`the claims of the '431 patent have a specific amount
`of tyloxapol recited in them?
` A. Yes.
` Q. And do you recall if that specific amount was
`0.02 percent tyloxapol?
` A. I don't know that I committed all the numbers
`to memory. Perhaps if I had it in front of me, I'd
`be able to confirm that, but it sounds familiar.
` Q. Mr. Hofmann, I'm handing you what has
`previously been marked as InnoPharma Exhibit 1001.
` A. Okay.
` Q. Is this the '431 patent that we were speaking
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`of just a moment ago?
` A. It appears to be.
` Q. And would you refer to claim 6 of the '431
`patent at column 12 thereof?
` A. Um-mm. I'm sorry. Yes.
` Q. And does claim 6 recite, "The aqueous liquid
`preparation according to claim 4, wherein the
`concentration of the tyloxapol is about 0.02 weight
`per volume percent"?
` A. I'm not a patent lawyer. I'm not a technical
`expert. That appears to be a dependent claim that
`does say what you said it does.
` Q. Okay. So, it particularly specifies the
`amount of the concentration of tyloxapol as about
`0.02 weight per volume percent, correct?
` A. That's what appears.
` Q. Okay. And same question. Mr. Hofmann, if
`you could please turn to column 13, and in
`particular claim 15. And does claim 15 specifically
`recite that the concentration of tyloxapol is about
`0.02 weight per volume percent?
` A. Again, not as a patent lawyer or a technical
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`expert, it does as a dependent claim appear to claim
`that weight per volume ratio that you described.
` Q. Okay. And if you could please turn to column
`14, claim 20. And can you tell me if claim 20 also
`recites for the claim aqueous liquid preparation a
`concentration of tyloxapol of about 0.02 weight per
`volume percent?
` A. You said claim 20?
` Q. Yes, please.
` A. Again, not as a patent lawyer or a technical
`expert, it appears as a dependent claim that it
`includes, among other things, the weight-to-volume
`ratio you described.
` Q. Okay. Is it your understanding that
`tyloxapol is a surfactant?
` A. Yes.
` Q. Are you familiar with the products Xibrom
`or -- strike that.
` Are you familiar with the product Xibrom?
` A. I am from a commercial perspective.
` Q. Does Xibrom contain a surfactant?
` A. My understanding is it does.
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` Q. Okay. And is the amount of surfactant in
`Xibrom -- sorry -- strike that.
` Is the surfactant in Xibrom polysorbate 80?
` A. Again, not from a technical or a formulation
`expert perspective, but yes, my understanding is it
`contains polysorbate 80.
` Q. Okay. Is it also your understanding that the
`petitioners in this case are of the view that the
`product Xibrom is an embodiment of the prior patent
`known as the Ogawa patent?
` MR. JANUSZ: Objection to scope.
` THE WITNESS: So, with respect to the
` technical aspects of prior art and the
` assertions of the petitioners, I would defer
` to the technical experts.
` My opinions are focused on secondary
` considerations from an economic perspective,
` but I have reviewed technical expert reports
` and I understand that there is -- there are
` assertions with respect to that prior art.
` Q. Have you considered the Ogawa patent before
`in connection with your opinions in your
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`declaration?
` MR. JANUSZ: Objection to scope.
` THE WITNESS: I think my opinions are
` contained in my report. They explain the
` basis and foundations therein. Included
` therein are various technical expert reports
` and declarations which include that as prior
` art.
` Q. I'd like to hand you the next exhibit which
`is InnoPharma Exhibit 1004, previously marked as
`such.
` Have you seen InnoPharma Exhibit 1004 before?
` A. Yes.
` Q. And have you considered it in connection with
`your opinions in this matter?
` A. Yes.
` Q. Okay.
` A. Again, not from a technical perspective.
` Q. And is Exhibit 1004 a copy of U.S. Patent
`4,910,225 to Ogawa, et al?
` A. Yes.
` Q. And if I refer to this as the Ogawa patent,
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`you understand what I mean?
` A. Yes.
` Q. Okay. So, is it your understanding that
`Xibrom is an embodiment of the Ogawa patent?
` A. Yes. Again, not from a technical
`perspective, but that's my understanding.
` Q. With regard to the Xibrom product and the
`surfactant that is contained in it, do you
`understand that that surfactant polysorbate 80 is
`present in a concentration of 0.15 weight per volume
`percent?
` A. That, again, not from a technical or
`formulation perspective, but that sounds familiar,
`yes.
` Q. And so, with the disclaimers that you put
`into your answers, is it your understanding that the
`amount of polysorbate 80 in Xibrom is 0.15 weight
`per volume percent?
` A. Again, subject to not from a technical or
`formulation perspective, I think that's my
`understanding.
` Q. Okay. So, as between the amount of
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`polysorbate 80 in Xibrom and the amount of tyloxapol
`as recited in the claims of the '431 patent, is it
`fair to say that the amount of tyloxapol is at a
`lower or a reduced concentration compared to the
`amount of polysorbate 80 in Xibrom?
` A. I mean, from a numeric percentage perspective
`as a non-technical expert, as a non-formulation
`expert, the numbers are what they are. It is a
`reduced concentration. Whether that has any
`meaningful implication with respect to the
`formulation or clinical implications, I would defer
`to, you know, to technical folks as opposed to
`economics.
` I think that, with that distinction, I
`haven't seen any meaningful implication with respect
`to the commercial side of things.
` Q. I believe you said in your previous answer
`that it -- that the amount of tyloxapol in the
`claims of the '431 is at a reduced concentration; is
`that correct?
` MR. JANUSZ: Objection.
` Mischaracterizes prior testimony.
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`Ivan T. Hofmann- March 25, 2016
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`THE WITNESS:
`
`I mean,
`
`I think my answer
`
`was, again, as a non-formulation expert, as a
`
`non-technical expert, the percentages --
`
`sure, as a mathematic exercise, are lower,
`
`but I just want to be careful as to whether
`
`there are any meaningful implications as a
`
`result of that.
`
`Q.
`
`I'm not asking you right now whether or not
`
`there are any meaningful implication as a result of
`
`the difference in concentration.
`
`I'm just asking,
`
`and really picking up on words that you used in your
`
`answer two answers ago, that the amount of tyloxapol
`
`and its concentrations is reduced compared to the
`
`amount of polysorbate 80 used in Xibrom, for
`
`example?
`
`A. As a simple exercise of math,
`
`I don't
`
`disagree with you.
`
`Q. Okay. You're familiar with the product
`
`Prolensa, correct?
`
`A.
`
`I am.
`
`•
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`•
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`Q.
`
`I'd like to hand you the next exhibit,
`
`1
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`5
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`6 Mr. Hofmann. This is InnoPharma Exhibit 1001 in IPR
`
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`proceeding 2015-00902 that pertains to the '290
`
`patent.
`
`So, because we have two exhibits that are
`
`10 marked as --
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`A. Yeah, that
`
`Q.
`
`-- Exhibit 1001, I'm just going to refer to
`
`them by their patent numbers just to keep the record
`
`clear.
`
`Is that okay?
`
`A. Yeah.
`
`I think that makes sense.
`
`Q. Okay. And so, the document you have before
`
`you that I've just handed to you, we're just going
`
`to refer to this for now as the '290 patent. Okay?
`
`A. That's fine.
`
`Q.
`
`In connection with your opinions in this
`
`case, have you considered the '290 patent?
`
`A. Yes, sir.
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` Q. Okay. And if you could please turn to the
`claims of this patent beginning on column 12 of the
`'290 patent?
` A. Okay.
` Q. And turning first to claim 11 at the bottom
`of column 12 of the '290 patent, does claim 11
`recite an aqueous liquid preparation that
`specifically contains a concentration of tyloxapol
`from about 0.01 weight per volume percent to about
`0.05 weight per volume percent?
` A. As a non-technical expert and a
`non-formulation expert, claim 11, which appears to
`be a dependent claim, contains the language you
`described as well as other aspects.
` Q. And that amount of, or that concentration of
`tyloxapol as recited in claim 11 is at a reduced
`amount compared with polysorbate 80 as contained in
`Xibrom, correct?
` MR. JANUSZ: Objection to scope.
` THE WITNESS: I think subject to a few
` answers ago where I caveated that I'm not a
` technical expert or a formulation expert, but
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` as a math question, weight-per-volume ratio
` of polysorbate 80, as I understand it, is
` higher in the Bromday and Xibrom
` formulations.
` Q. Okay. Okay. So, quickly --
` MR. DINER: Thank you for making copies
` of the declaration of Ivan Hofmann.
` Q. And, Mr. Hofmann, I'm going to re-hand you a
`copy of what appears to be your declaration in these
`matters. And this is --
` MR. DINER: Could you put a sticker on
` it?
` MS. STACK: Okay.
` (Discussion off the record.)
` MR. JANUSZ: Just to clarify, I know
` that that's the protective order of material
` version, but I do know that, obviously, the
` redacted public version should have an
` exhibit number when we filed.
` MS. STACK: The redacted version? I can
` double-check, but I believe it's --
` MR. JANUSZ: If you want to put a new
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` number on it, that's fine. If you wanted to
` refer to Exhibit, I want to say it was 1150,
` but that's fine.
` MR. DINER: You mean in terms of the
` redacted version? This is the unredacted
` version.
` MR. JANUSZ: Right. Right. Right. But
` it should -- I mean, it would correlate to
` the same exhibit number. That's fine. If
` you guys want to do that, that's fine.
` MS. STACK: The redacted version is 1150
` and then we can use 1150 for the unredacted
` version.
` MR. JANUSZ: That's fine.
`BY MR. DINER:
` Q. So, Mr. Hofmann, I'm handing you again Innopharma
`Exhibit 1150, which I believe is a complete copy now
`of your declaration in this matter.
` A. I haven't studied every page, but it appears
`to be, yes.
` Q. It appears to be a copy of your declaration?
` A. Yes.
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` Q. And did you also happen to notice that it's
`in color?
` A. This time, yes.
` Q. Okay. And if you could turn in your
`declaration to page 73 and confirm that that's your
`signature appearing on that page?
` A. I'd just point out there's two different
`pagination references. There's the center page 73
`that you referred to and then there's I think the
`IPR reference of page 75, but yes, that is my
`signature that appears there.
` Q. Okay. Are there any changes or corrections
`that you would wish to make to your declaration at
`this time?
` A. None that come to mind.
` Q. You can put this aside for now, but we'll be
`going back to it.
` A. Okay.
` Q. Mr. Hofmann, I'm handing you now what has
`been marked as Senju Exhibit 2130. Take a moment
`and look at that for me, please.
` A. Okay. I've taken a quick look at it.
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` Q. Have you seen this document before?
` A. It appears to be a version of the declaration
`of Mr. Jarosz. I noticed on Appendix 11 there's
`some highlights. I don't know if you want that as
`part of the evidentiary record or if you want a
`clean version. We'll trade. This one doesn't have
`the label on it, but we can clean that up at some
`point. Trade again? Okay.
` I'm sorry. Is there a pending question?
` Q. So, did you consider the Declaration of John
`C. Jarosz in connection with your opinions in this
`matter?
` A. I did.
` Q. Okay. Would you please turn to page 35 and
`36 of the Declaration of John Jarosz, and take a
`moment to read paragraph 85, if you will?
` A. 85?
` Q. On page 36.
` A. Yep. Okay. I've re-read it.
` Q. Is it your understanding that Mr. Jarosz has
`been offered into this matter by Patent Owners in
`support of the secondary consideration of commercial
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`success?
` A. Yes, by the respondents, their licensees, but
`yeah.
` Q. By Senju, et al?
` A. Yes.
` Q. And so as you read paragraph 85 is it your
`unde
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