3/27/2018
`
`Argentum Pharmaceuticals LLC, v. Cipla Ltd.
`
`Maureen D. Donovan
`
` UNITED STATES PATENT AND TRADEMARK OFFICE
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`Page 1
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` ARGENTUM PHARMACEUTICALS LLC,
` Petitioner
` v.
` CIPLA LTD.
` Patent Owner
` Patent No. 8,168,620
` IPR2017-00807
`
` Deposition of MAUREEN D. DONOVAN, PH.D., at
` the offices of Foley & Lardner, 321 North
` Clark Street, Chicago, Illinois, before
` Janice M. Kocek, IL-CSR and CLR,
` commencing at the hour of 9:07 a.m. on
` Tuesday, March 27, 2018.
`
`__________________________________________________________
` DIGITAL EVIDENCE GROUP
` 1730 M Street, NW, Suite 812
` Washington, D.C. 20036
` (202) 232-0646
`
`www.DigitalEvidenceGroup.com
`
`Digital Evidence Group C'rt 2018
`
`202-232-0646
`
`1
`
`CIP2178
`Argentum Pharmaceuticals v. Cipla Ltd.
`IPR2017-00807
`
`
`
`Argentum Pharmaceuticals LLC, v. Cipla Ltd.
`
`Maureen D. Donovan
`
` UNITED STATES PATENT AND TRADEMARK OFFICE
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`Page 1
`
` ARGENTUM PHARMACEUTICALS LLC,
` Petitioner
` v.
` CIPLA LTD.
` Patent Owner
` Patent No. 8,168,620
` IPR2017-00807
`
` Deposition of MAUREEN D. DONOVAN, PH.D., at
` the offices of Foley & Lardner, 321 North
` Clark Street, Chicago, Illinois, before
` Janice M. Kocek, IL-CSR and CLR,
` commencing at the hour of 9:07 a.m. on
` Tuesday, March 27, 2018.
`
`__________________________________________________________
` DIGITAL EVIDENCE GROUP
` 1730 M Street, NW, Suite 812
` Washington, D.C. 20036
` (202) 232-0646
`
`www.DigitalEvidenceGroup.com
`
`Digital Evidence Group C'rt 2018
`
`202-232-0646
`
`1
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`CIP2178
`Argentum Pharmaceuticals v. Cipla Ltd.
`IPR2017-00807
`
`
`
`3/27/2018
`
`Argentum Pharmaceuticals LLC, v. Cipla Ltd.
`
`Maureen D. Donovan
`
`Page 2
`
`APPEARANCES:
`ON BEHALF OF THE PETITIONER:
` FOLEY & LARDNER LLP
` BY: MICHAEL R. HOUSTON, PH.D., ESQ.
` 321 North Clark Street
` Suite 2800
` Chicago, Illinois 60654-5313
` 312.832.4378
` mhouston@foley.com
`
`ON BEHALF OF THE PATENT OWNER:
` STERNE KESSLER GOLDSTEIN & FOX PLLC
` BY: ADAM C. LaROCK, ESQ.
` 1100 New York Avenue, NW
` Washington, DC 20005
` 202.371.2600
` alarock@skgf.com
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`Argentum Pharmaceuticals LLC, v. Cipla Ltd.
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`Maureen D. Donovan
`
`Page 3
`
` INDEX
` PAGE
`MAUREEN D. DONOVAN, PH.D.
` Examination by Mr. LaRock 5
`
` EXHIBITS
` PAGE
`Exhibit 1001 United States Patent 210
` 8,168,620 B2
`Exhibit 1007 United States Patent 73
` 8,164,194
`Exhibit 1008 "Physicians' Desk 123
` Reference" 54th Edition 2000
`Exhibit 1165 Second Declaration of 6
` Dr. Maureen D. Donovan, Ph.D.
` (Argentum vs. Cipla)
`Exhibit CIP2016 Expert Report of 169
` Maureen D. Donovan, Ph.D.
` (Meda v. Apotex)
`Exhibit CIP2110 "Handbook of 176
` Pharmaceutical Excipients"
` (Argentum vs. Cipla)
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`Maureen D. Donovan
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`Page 4
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` EXHIBITS (Continued)
` PAGE
`Exhibit CIP2176 Second Declaration of 134
` Hugh David Charles
` Smyth, Ph.D.
` (Argentum vs. Cipla)
`Exhibit CIP2177 Direct Examination 46
` Demonstratives of
` Maureen Donovan, Ph.D.
` DDX 5.00 - 5.56
` (Meda and Cipla vs. Apotex)
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`Maureen D. Donovan
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` (Witness sworn.)
` MAUREEN DONOVAN, Ph.D.,
` called as a witness herein, having been
` first duly sworn, was examined and
` testified as follows:
` EXAMINATION
`BY MR. LAROCK:
` Q. Good morning. Can you state your full
`name for the record, please.
` A. Maureen Donovan.
` Q. And my name is Adam LaRock. I
`represent Cipla. And do you understand you're here
`on behalf of Argentum Pharmaceuticals?
` A. Yes.
` Q. And you've been deposed previously?
` A. Yes, I have.
` Q. Yeah. About how many times?
` A. About ten times.
` Q. Okay. And you were deposed a couple of
`times on the '620 patent that is at issue?
` A. On things relevant to the '620 patent,
`yes.
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` Q. Your opinions on the '620 patent?
` A. Yes.
` Q. Would you say you're familiar with the
`deposition rules in general?
` A. In general, yes.
` Q. Okay. Well, as a refresher, I'll ask
`some questions, you'll provide answers to those
`questions.
` If I ask a question, you provide an
`answer, I'm going to assume that you understood it,
`that you heard it.
` Is that fair?
` A. Sure.
` Q. And Mike may have some objections at
`times. But unless he instructs you not to answer,
`you're supposed to answer my questions.
` A. Okay.
` Q. Okay. And is there any reason why you
`can't provide truthful testimony today?
` A. No.
` Q. So I've just handed you what's been
`previously marked Exhibit 1165. And do you
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`Maureen D. Donovan
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`recognize this exhibit?
` (Witness examining document.)
` THE WITNESS: Well, I recognize it
` except for the redacted portion.
`BY MR. LAROCK:
` Q. Do you recognize -- do you understand
`that at one point in time you had cited to
`confidential information?
` A. Yes.
` Q. And then I think your counsel redacted
`out a portion of it when it was publicly filed.
` A. Okay. I'll -- then -- then -- I mean,
`yes. This -- this looks to be, without me reading
`every word, my second declaration. And I'll --
`I'll leave it to understanding that that was
`redacted before it went public.
` Q. Okay. But I'm saying, besides that
`redacted -- redaction, you're familiar with --
`that's right?
` A. Yes.
` Q. And that's your signature on the last
`page, page 41?
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`Maureen D. Donovan
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` A. Yes, it is.
` Q. Okay. And in paragraph 3 of 1165, you
`say that you considered patent owner's response,
`right?
` A. Yes.
` Q. And then Dr. Smyth's second
`declaration, right?
` A. That's correct.
` Q. Dr. D'Addio's second declaration,
`right?
` A. Yes.
` Q. Dr. Heperin's declaration?
` A. Yes.
` Q. And then the documents cited in those?
` A. Correct.
` Q. So I want to understand what you mean
`by that. So you -- in preparing your -- first of
`all, let me back up.
` So your second declaration, is it fair
`that we just call it either your second declaration
`or reply declaration?
` A. Either is fine. I'll know what you're
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`talking about.
` Q. So in preparing your reply declaration,
`you reviewed Mr. Smyth's second declaration,
`Mr. D'Addio's second declaration, Dr. Heperin's
`declaration, and the documents cited in those,
`right?
` A. Yes.
` Q. And you reviewed them to see where you
`had disagreements with what their opinions were and
`the documents they cited, right?
` A. Well, I -- I reviewed what the
`documents said themselves.
` Q. Okay.
` A. And on various cites, citations,
`references, that -- that appeared in any of those,
`if I wasn't quite familiar with the area or was
`wondering what reference it is that that individual
`was referring to, I went and referred to the
`citations.
` Q. You said -- so you said that when you
`were reviewing Dr. Smyth's second declaration,
`Dr. D'Addio's second declaration, and Dr. Heperin's
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`declaration, if you found something you weren't
`quite familiar with, you kind of dug into that?
` A. Well, that or I just wanted to expand
`my understanding what basis those statements were
`being made. You know, a number of things, a
`statement of fact that I'm well aware of, I don't
`need to go check the cite for.
` Q. And -- and what areas in Dr. Smyth's
`second declaration, Dr. D'Addio second declaration,
`and Dr. Heperin's declaration did you have to go
`back and look into a little bit to familiarize
`yourself?
` A. I don't have any recollection on what I
`looked into.
` Q. Okay. Okay.
` So I think where we were with -- you
`had reviewed Dr. Smyth's second declaration,
`Dr. D'Addio second declaration, Dr. Heperin's
`declaration, and you found where you had disagreed
`with what their opinions were?
` A. I don't think that's a -- a fair
`description of what I said.
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` Q. Okay.
` A. I said I read their materials. I
`broadened my knowledge based on what citations they
`were using to support their arguments. I evaluated
`what I thought of the -- the statements being made
`in those declarations, what I understood from the
`references, a whole number of things. But it
`wasn't just focused on what I might have disagreed
`with.
` Q. Okay. So what areas of Dr. Smyth's
`declaration do you agree with?
` A. I would have to see Dr. Smyth's
`declaration to recall what things I -- I understand
`or are simply a statement of fact in his and which
`are his opinions and which of those are -- are
`commonly held and which are unique to Dr. Smyth.
` Q. Would it be fair to say that your
`second declaration, Exhibit 1165, highlights some
`differences between what Dr. Smyth thought and what
`you think?
` A. I believe there's discussion in this
`declaration where I clearly state that Dr. Smyth
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`states something or relies on information that I --
`I consider in a different light and have a
`different opinion.
` Q. Okay. That's -- that's all I'm trying
`to get is that you reviewed these things and then
`where you had a different viewpoint you then wrote
`it down.
` A. That might be an overgeneralization of
`the process. But there are places in this document
`where I provide my opinion which might not be in
`alignment with Dr. Smyth's opinion.
` Q. Okay. And you provided your second
`declaration for the Patent Office to rely on in
`making a decision about the '620 patent? Is that
`fair to say?
` A. In some general manner, as best I
`understand how IPR proceedings work.
` Q. And if you had a -- a viewpoint that
`was different from either Dr. Smyth or Dr. D'Addio
`or Dr. Heperin that you thought was meaningful, you
`would want to make sure that the -- you wrote it
`down in your second declaration, that the Patent
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`Office was aware of it?
` A. Well, my second declaration was
`composed under advice and work with counsel. And
`I'm not the only expert in this case that I'm aware
`of. And so, you know, I made comments in this
`report that I thought were reflective of the -- the
`information that were the bases for my opinions.
`I've expressed other opinions in previous reports
`in this case that might not have recurred in this
`one.
` Q. So within your field of expertise, when
`you're reviewing Dr. Smyth's second declaration,
`Dr. D'Addio's second declaration, Dr. Heperin's
`declaration, and your viewpoints were different and
`you thought it was a meaningful difference, would
`you have written them down in your second
`declaration?
` A. I don't know. I mean, I'm sure I would
`have thought about them. I would have thought
`about them in context of the claims of the '620.
`And things I might have differed on might not be
`relevant to those claims. And so, you know, there
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`are -- there are a number of instances of how I
`would have selected the -- the information that's
`contained in this second declaration.
` Q. So if there were instances where you
`agreed with Dr. Smyth and Dr. D'Addio and
`Dr. Heperin, you would have said I agree or --
` A. Not in every instance. A lot of --
`there again, many of the statements of fact are
`statements of fact that I don't differ with. So I
`didn't feel the need to report in that, yep, I -- I
`agree with that, everybody agrees with that. It's
`a statement of fact.
` Q. But I just want to make sure that your
`second declaration, 1165, contains what you think
`was meaningful to write down and point out to the
`Patent Office.
` A. Well, these are key elements in my --
`of my responses or my -- my reflections on the
`information I looked at and I think key elements
`where I needed to express my opinion to the Patent
`Office.
` Q. Because you wanted the Patent Office to
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`rely on --
` A. Well, I wanted them to understand what
`-- what my opinion was as an expert in this case.
` Q. Okay. Okay.
` And if there were some fundamental flaw
`with Dr. Smyth's second declaration, Dr. D'Addio's
`second declaration, or Dr. Heperin's declaration,
`you would have pointed that out in your second
`declaration?
` A. I -- I guess I need to understand what
`you mean by "fundamental flaw."
` Q. Well, if you thought they were -- one
`of these guys was completely wrong on the science,
`would you -- and because of that, their opinion you
`thought was inaccurate, would you have highlighted
`that in your second declaration?
` A. Each of -- each of these individuals of
`these -- each of these individuals has a long
`history as a scientist. So I -- I -- I'm starting
`from a point where I respect their scientific
`ability. So I don't think anybody any of them, you
`know, doesn't understand science and understand the
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`world.
` They -- they have their opportunity to
`evaluate things, communicate that, have me decide
`whether I agree with their evaluation of -- of
`those facts or not. But -- and -- and in areas
`where I thought relevant to the '620, relevant to
`my opinion that needed to be communicated to the
`Patent Office, that's what's in this declaration.
` Q. Okay. Yeah, I think that's what I was
`getting at, which is what you thought was going to
`be relevant to your opinion that you wanted the
`Patent Office to hear, you wrote those down after
`looking at Dr. Smyth's second declaration,
`Dr. D'Addio's second, and Dr. Heperin's
`declaration, and then you put forward that opinion
`and the basis for that opinion in your second
`declaration.
` A. In essence, yes. There may be other
`things that I've even further considered since that
`time and have many -- in many cases I have
`additional questions about how opinions were
`arrived at or how things were done that would allow
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`www.DigitalEvidenceGroup.com
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`Digital Evidence Group C'rt 2018
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`202-232-0646
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`3/27/2018
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`Argentum Pharmaceuticals LLC, v. Cipla Ltd.
`
`Maureen D. Donovan
`
`Page 17
`me to then form other opinions. But at the time
`that -- this is -- these were the areas that I felt
`were relevant to the '620 patent that I had an
`opinion that I wanted to express in the document.
` Q. Okay. Okay. That's fair.
` And you also -- besides your second
`declaration, you also submitted a first
`declaration; is that right?
` A. Yes.
` Q. And that was sometime in early 2017.
`Does that sound about right?
` A. Yeah. February-ish or something like
`that.
` Q. And that document was submitted in
`support of Argentum's petition to the Patent
`Office; is that right?
` A. Again, I am not an expert in IPR
`mechanisms and --
` Q. Okay.
` A. So if that's -- if that's the legal
`version of how that supports things, then yes.
` Q. Okay. And I think you said earlier
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`202-232-0646
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`3/27/2018
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`Argentum Pharmaceuticals LLC, v. Cipla Ltd.
`
`Maureen D. Donovan
`
`Page 18
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`that you had been deposed a couple of previous
`times on the '620 patent. Does that sound about
`right?
` A. Well, I was deposed regarding my first
`declaration.
` Q. Right. Sorry. I didn't mean to cut
`you off.
` A. That's all right. And then I was
`deposed in a previous case where the '620 patent
`was one of the patents at issue.
` Q. And that was a district court case --
` A. Yes.
` Q. -- where you were then retained on
`behalf of Apotex, right?
` A. That's correct.
` Q. And I think you said it involved the
`'620 patent that's also at issue here?
` A. It did, yes.
` Q. And then it also involved endista
`(phonetic) that's also at issue here?
` A. Yes.
` Q. And you had been retained on behalf of
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`Digital Evidence Group C'rt 2018
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`202-232-0646
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`3/27/2018
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`Argentum Pharmaceuticals LLC, v. Cipla Ltd.
`
`Maureen D. Donovan
`
`Page 19
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`Apotext in that case?
` A. Yes.
` Q. And your opinion there in that -- I'll
`just call that the Apotex case. Is that fair?
` A. Sure.
` Q. And then your opinion in that Apotex
`case was that the '620 patent was obvious; is that
`right?
` A. I mean, I guess I'd like to refer to
`what my opinion clearly was. There were different
`patent claims. There were different patents and so
`forth. It's been a long time since that case.
` Q. Okay.
` A. So I -- before I can just blatantly
`state the entire patent was obvious, I'd need to
`refer to my opinion.
` Q. Okay. But generally speaking, you --
`your opinion was that -- I understand that there
`was other patent claims at issue, maybe even other
`patents at issue, but that the '620 patent was not
`valid? That was your very overarching opinion?
` A. Again, there were -- there was either
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`www.DigitalEvidenceGroup.com
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`Digital Evidence Group C'rt 2018
`
`202-232-0646
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`3/27/2018
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`Argentum Pharmaceuticals LLC, v. Cipla Ltd.
`
`Maureen D. Donovan
`
`Page 20
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`-- there were specific claims or whatever, but
`there were portions of the '620 patent that I
`believed were either -- yeah, that I believed were
`obvious.
` Q. And those were the portions of the '620
`patent, whichever ones they were, that were in that
`Apotex case?
` A. That's my recollection.
` Q. Okay. And then in the Apotex case you
`went to trial, right?
` A. That is correct.
` Q. In December 2016?
` A. Yes.
` Q. And then you testified under oath in
`front of the District of Delaware I think it was?
` A. Yeah, that's correct.
` Q. And then you expressed your opinions
`there?
` A. Yes.
` Q. Dr. Donovan, I'm going to ask you to
`turn to paragraphs 68 and 69 of your second
`declaration.
`
`www.DigitalEvidenceGroup.com
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`Digital Evidence Group C'rt 2018
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`202-232-0646
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`3/27/2018
`
`Argentum Pharmaceuticals LLC, v. Cipla Ltd.
`
`Maureen D. Donovan
`
`Page 21
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` A. I'm ready.
` Q. Okay. So is it fair to say -- so in --
`in paragraph 68 and 69, it's your opinion that the
`person of ordinary skill in 2002 would have avoided
`using sodium chloride and dextrose as tonicity
`adjusters in combination formulation of azelastine
`hydrochloride and fluticasone propionate?
` A. Well, a person of ordinary skill, when
`they're trying to adjust the tonicity of a
`formulation, is aware of -- of -- you know, several
`possible materials that they might be able to
`consider. And so the POSA thinks about what
`attributes they think might be best or what
`attributes might -- might limit their formulation.
` So what I've expressed in paragraph 68
`and 69 are some of the issues that a POSA would
`have considered regarding sodium chloride, using it
`as a tonicity adjuster. It could have been used.
`But it's got some drawbacks as being an ionic
`material and potentially wanting to avoid adding
`additional extraneous ionic compounds, the POSA
`would likely select against that initially.
`
`www.DigitalEvidenceGroup.com
`
`Digital Evidence Group C'rt 2018
`
`202-232-0646
`
`21
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`
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`3/27/2018
`
`Argentum Pharmaceuticals LLC, v. Cipla Ltd.
`
`Maureen D. Donovan
`
`Page 22
` Same thing with dextrose. Dextrose has
`issues in low concentrations in formulations,
`especially formulations that were trying to remain
`sterile. And so the POSA would likely select
`against that also.
` If -- if other agents turned out to be
`totally unworkable, you could consider these. But
`initially, there would likely be choices other than
`those two for specifically the -- the reasons I
`point out here and maybe some additional reasons
`that. Those would not necessarily have been the
`first choices.
` Q. So just to unpack your answer a little
`bit, though there's multiple tonicity adjusters
`that the person in 2002 -- that the person of
`ordinary skill could potentially have used?
` A. Yes.
` Q. But you write here that the person of
`ordinary skill would have been motivated to avoid
`sodium chloride. That's in paragraph 68 and 69, "a
`POSA would have been motivated to avoid using
`dextrose."
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`
`Digital Evidence Group C'rt 2018
`
`202-232-0646
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`22
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`
`
`3/27/2018
`
`Argentum Pharmaceuticals LLC, v. Cipla Ltd.
`
`Maureen D. Donovan
`
`Page 23
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` A. That's what they say, uh-huh.
` Q. So -- so it would have been obvious --
`would sodium chloride and would dextrose have been
`obvious to use in a combination formulation of
`fluticasone propionate and azelastine
`hydrochloride, given what you've articulated in
`paragraph 68 and 69 of your --
` A. Well, both sodium chloride and dextrose
`are known agents that get used to adjust tonicity.
` Q. Right.
` A. So a POSA would certainly be aware of
`them and -- and know that they -- they could choose
`them. What I said was a POSA knows of these
`agents, knows of their characteristics, knows of
`the goals of the formulation, and essentially
`prioritizes the -- the selection or the -- the
`investigation of them. And there were several --
`there were characteristics of both sodium chloride
`and dextrose that a POSA would have known that
`would have motivated the POSA to select a different
`tonicity adjusting agent.
` Q. So what I'm trying -- what I'm trying
`
`www.DigitalEvidenceGroup.com
`
`Digital Evidence Group C'rt 2018
`
`202-232-0646
`
`23
`
`
`
`3/27/2018
`
`Argentum Pharmaceuticals LLC, v. Cipla Ltd.
`
`Maureen D. Donovan
`
`Page 24
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`to get to the bottom of is, if the POSA was
`motivated to avoid sodium chloride and avoid
`dextrose, would they have been obvious tonicity
`adjusters to use in an azelastine fluticasone
`formulation?
` MR. HOUSTON: Objection. Asked and
` answered.
` THE WITNESS: As I said, the -- a POSA
` is aware that sodium chloride gets used to
` adjust tonicity. They're aware that dextrose
` gets used to adjust tonicity. They're aware
` of other materials that get used to adjust
` tonicity. They're aware that every material
` that they use that's in solution adjusted the
` tonicity.
` So what they -- if they feel that they
` need to add a material to a formulation to
` increase the tonicity of that formulation,
` they then consider characteristics of those
` materials and choose among them or test
` several of them to determine which one they
` want to finally use.
`
`www.DigitalEvidenceGroup.com
`
`Digital Evidence Group C'rt 2018
`
`202-232-0646
`
`24
`
`
`
`3/27/2018
`
`Argentum Pharmaceuticals LLC, v. Cipla Ltd.
`
`Maureen D. Donovan
`
`Page 25
` Again, I've identified why dextrose and
` sodium chloride in the case of these -- in
` the case of the formulation or -- so let me
` -- and in paragraph 68, the issue with sodium
` chloride primarily that would cause a
` formulator to avoid it in -- in this system
` is that the suspending agent is -- is known
` to -- hydrates better or continues its
` hydration -- or gives it the -- the desired
` characteristics when it has sufficient water
` activity to hydrate. And it -- it --
` additional high concentrations of ions
` reduces the water activity and -- and that
` becomes -- it may become an issue.
`BY MR. LAROCK:
` Q. What --
` A. And so it's knowing that about sodium
`chloride. You've -- you've sort of asked general
`questions about a blank-blank formulation. I don't
`know, depends on what else is in there.
` The -- the dextrose issue is about
`bacterial growth. Other -- the formulations
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`
`Digital Evidence Group C'rt 2018
`
`202-232-0646
`
`25
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`
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`3/27/2018
`
`Argentum Pharmaceuticals LLC, v. Cipla Ltd.
`
`Maureen D. Donovan
`
`Page 26
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`containing dextrose can contain sufficient
`antimicrobial preservatives to ward against that.
`So I can't answer in an all general, all
`formulations.
` It's about a specific formulation
`process and how a POSA goes about identifying which
`are -- which are the -- the -- which agents they're
`going to look at first of potentially a group of
`materials that they likely feel would give the
`result that they're looking for.
` Q. And that group of agents that's being
`looked at first, those would be obvious?
` A. Well, they would be known.
` Q. Right. I mean, it would be -- it would
`be known. And would it be obvious for the person
`of ordinary skill to use those agents as tonicity
`adjusters?
` A. Which agents --
` Q. You said --
` A. -- specifically?
` Q. You said that there was prioritization,
`right? So you said there was a group of agents
`
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`
`Digital Evidence Group C'rt 2018
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`202-232-0646
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`26
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`
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`3/27/2018
`
`Argentum Pharmaceuticals LLC, v. Cipla Ltd.
`
`Maureen D. Donovan
`
`Page 27
`that the person of ordinary skill would look at
`first that would likely give the -- likely feel
`that they would give the result that they're
`looking for.
` Does that sound about right?
` A. I'm not sure. So either if there's a
`-- if there's a particular phrase you want to back
`to and you want to have it reread to me, that's
`fine. Otherwise, if we can just clarify a question
`that I can answer, that would -- I can -- I can
`answer.
` Q. Okay. So I think you said that there's
`prioritization of excipients that the POSA in 2002
`was going through in order to figure out whether
`they're going to -- what tonicity adjuster they're
`going to use in a formulation.
` Is that --
` A. Well, they -- they're aware of -- of
`agents that are used as tonicity adjusters and they
`-- they make a decision about which ones they're --
`they're going to focus on to start with.
` Q. Uh-huh.
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`Digital Evidence Group C'rt 2018
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`202-232-0646
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`27
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`3/27/2018
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`Argentum Pharmaceuticals LLC, v. Cipla Ltd.
`
`Maureen D. Donovan
`
`Page 28
` A. Doesn't mean that they exclude all of
`them forever. But you narrow down your initial
`approaches.
` Q. And the group of those known tonicity
`adjusters that the person of ordinary skill is
`focusing in on, those would be obvious tonicity
`adjusters to use in the formulation?
` A. Well, again, there's lots of materials
`that can be used as tonicity adjusters. A POSA
`would consider the tonicity adjusters that are used
`in -- in similar products, in -- that they've used
`before, that are used frequently. So -- and then
`they would select based on those characteristics
`and the characteristics and goals of their
`formulations which ones they thought would be best
`suited for the specific formulation that they were
`concerned with.
` Q. And if a tonicity adjuster wasn't going
`to give the -- didn't have or wasn't going to give
`the characteristics that the person of ordinary
`skill wanted, that would either -- that would be
`crossed off the list of tonicity adjusters to use
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`Digital Evidence Group C'rt 2018
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`202-232-0646
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`3/27/2018
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`Argentum Pharmaceuticals LLC, v. Cipla Ltd.
`
`Maureen D. Donovan
`
`Page 29
`or put at the bottom of the list? How would that
`work?
` A. I think it's -- it's, again, an order
`of prioritization. The tonicity adjuster that the
`POSA thought would be most advantageous would be
`looked at first. And if that turned out to be not
`as advantageous, then based on what was observed
`about why that didn't give the intended results, a
`different agent would be selected based on its
`properties that wouldn't have duplicated what the
`POSA thought was the negative effect of the one
`that was initially selected.
` Q. Okay. So let's take, for example,
`sodium chloride. And you have a combination
`formulation of azelastine hydrochloride fluticasone
`propionate. You're trying to look for a tonicity
`adjuster for the -- to use in that formulation.
` A. Okay.
` Q. And where would sodium chloride be on
`the list of tonicity adjusters that the person of
`ordinary skill would be thinking of?
` A. Depends on what else is in the
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`Digital Evidence Group C'rt 2018
`
`202-232-0646
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`29
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`3/27/2018
`
`Argentum Pharmaceuticals LLC, v. Cipla Ltd.
`
`Ma
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