`
`STEPHEN G. DAVIES D.PHIL.
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`patent
`
`column 7 where we were at before.
`
`MS. LEBEIS
`
`I
`
`think youre looking
`
`at
`
`the 984.
`
`Q
`
`Yes Ill
`
`get
`
`there in a minute.
`
`You
`
`can have that one open.
`
`A
`
`Q
`
`Which exhibit number
`
`Its the one that you have open in
`
`front of you I believe.
`
`A
`
`Q
`
`This one okay.
`
`Yes.
`
`Q
`
`it.
`
`So if
`
`you look at
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`the
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`A
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`560 got
`560 yes.
`560 patent
`
`--15A
`
`Yes.
`
`Q
`
`-- as we
`
`just discussed in the 560
`
`patent we see a report of a formulation of
`
`diclofenac
`
`BAC and octoxynol
`
`forming no
`
`precipitate after storage right
`
`MS. LEBEIS Objection to the extent
`
`it mischaracterizes the document.
`
`A
`
`Q
`
`A
`
`After 41 days at
`
`4 degrees.
`
`Right.
`
`In that particular
`
`formulation
`
`theres no precipitate it says.
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`The Little Reporting Company
`646 650-5055
`www.littlereporting.com
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`Page 221
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`Q
`
`222
`
`STEPHEN G. DAVIES D.PHIL.
`Then if we look back at EP 984 page
`9 likewise there was a --
`
`theres a report
`
`in
`
`this patent of a clear solution with no
`
`precipitate of ketorolac
`
`benzalkonium
`
`chloride and octoxynol
`
`40 after storage at
`
`various conditions right
`
`MS. LEBEIS Objection to the extent
`
`it mischaracterizes the document.
`
`Objection to the form of
`
`the question.
`
`A
`
`Well
`
`theyre two different
`
`formulations for two different drugs.
`
`Q
`
`Right.
`
`So in each of
`
`these patents
`
`we see a formulation of an NSAID benzalkonium
`
`chloride and octoxynol
`
`40 showing no
`
`precipitate after storage at
`
`4 degrees right
`
`MS. LEBEIS Objection to the form of
`
`the question.
`
`A
`
`We havent
`
`seen any evidence of
`
`anything ever
`
`forming a precipitate of
`
`benzalkonium chloride and an NSAID.
`Im not asking about
`
`Q
`
`a precipitate of
`
`benzalkonium chloride and an NSAID.
`think my
`Im just
`
`question was simpler than that.
`
`I
`
`asking in each of
`
`these patents the 560
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`Page 222
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`223
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`STEPHEN G. DAVIES D.PHIL.
`
`patent and the 984 patent
`
`we see a
`
`formulation of an NSAID benzalkonium chloride
`
`and octoxynol
`
`40 showing no precipitate after
`
`storage at
`
`4 degrees right
`
`MS. LEBEIS Objection to the form of
`
`the question.
`
`And objection
`
`mischaracterizes the documents.
`
`A
`
`4 degrees
`
`isnt one of
`
`the
`
`temperatures of --
`
`in example 5 of
`
`the 984.
`
`Q
`
`Let me change the question then.
`in each of EP 984 and the 560 patent
`
`So
`
`we have
`
`formulations of an NSAID benzalkonium
`
`chloride and octoxynol
`
`40 showing no formation
`
`of
`
`a precipitate after storage at all
`
`the
`
`conditions tested in each of
`
`these patents
`
`right
`
`MS. LEBEIS Objection to the form of
`
`the question and to the extent
`
`it
`
`mischaracterizes
`
`the documents.
`
`A
`
`I dont
`
`think you can
`
`take an
`
`experiment out of one patent under one set of
`
`conditions and compare it
`
`to an experiment
`
`in
`
`-- under
`
`a different
`
`set of conditions in
`
`another patent but
`
`a different drug.
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`The Little Reporting Company
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`224
`
`STEPHEN G. DAVIES D.PHIL.
`
`Q
`
`I wasnt asking you to do any
`
`comparison here.
`
`I was
`
`just asking you whether
`
`or not you agree that
`
`in each of
`
`the 560 and
`
`EP 984 patents we have a formulation of an
`
`NSAID benzalkonium chloride and octoxynol
`
`40
`
`showing no formation of a precipitate after
`
`storage at each of
`
`the conditions tested in
`
`those patents.
`
`MS. LEBEIS Objection to the form of
`
`the question and to the extent
`
`it
`
`mischaracterizes the documents
`
`and asked
`
`and answered.
`
`A
`
`I dont
`
`think you can make a
`
`comparison.
`
`There were conditions where you
`
`have a clear solution in the 984 patent
`
`and
`
`theres --
`
`for a completely different
`
`experiment with different actives.
`
`Theres
`
`apparently no precipitate in the 560.
`
`Q
`
`When you say that
`
`these are
`
`completely different experiments can
`
`you
`
`explain what
`
`you mean by that
`
`A
`
`Well
`
`the temperature raisings are
`
`not
`
`the same.
`
`The active ingredient
`
`is not
`
`the
`
`same.
`
`I havent
`
`looked at
`
`the -- all
`
`the
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`The Little Reporting Company
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`225
`
`STEPHEN G. DAVIES D.PHIL.
`
`ingredients so I have to look at
`
`the
`
`ingredients.
`
`Document
`
`review.
`
`The ingredients in the 984 seem to
`
`include sodium EDTA which doesnt appear
`
`to be
`
`in the comparative example C in the 560.
`
`Sodium chloride appears
`
`to be in the 984 and
`
`not
`
`in the comparative example C in the 560 so
`
`theyre not comparable conditions.
`
`Q
`
`Are you -- are you assuming that
`
`the
`
`ingredients listed in example 4 are the ones
`
`that are in the formulations tested in example
`5
`
`MS. LEBEIS Objection to the extent
`
`it mischaracterizes prior testimony.
`Im looking at all of
`page 8 and all
`
`A
`
`the examples on
`
`the -- and 7 and 6 all contain
`
`those ingredients.
`
`Q
`
`So youre making the assumption that
`
`those ingredients are in the formulations
`tested in example 5
`MS. LEBEIS Objection to the extent
`
`it mischaracterizes prior testimony.
`
`Asked
`
`and answered.
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`The Little Reporting Company
`646 650-5055
`www.littlereporting.com
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`Page 225
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`STEPHEN G. DAVIES D.PHIL.
`
`226
`
`Well example 5 says the --
`A
`984 it says The formulations of
`invention have proven to be stable and that
`
`in the
`
`the present
`
`is the data for that.
`
`And every formulation
`thats in that 984 has those ingredients.
`
`Q
`
`Okay.
`
`So youre assuming again that
`
`the ingredients in the formulations tested in
`
`example 5 are the same as the ingredients
`7 and 8
`MS. LEBEIS Objection to the extent
`
`listed in the other examples on pages
`
`it mischaracterizes prior testimony and
`
`mischaracterizes
`
`the document.
`
`Asked and
`
`answered.
`Im reading the document
`
`A
`
`for what
`
`it
`
`is and it
`
`seems to me to state that
`
`theyre
`
`testing the formulations that are in the
`
`invention all of which contain those
`
`ingredients.
`
`17
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`18
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`19
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`20
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`21
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`23
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`--22the experiment
`
`Q
`
`In your view the experiments in the
`
`560 patent and in the experiments in the
`
`in the EP 984 patent arent
`
`comparable
`
`at
`
`least
`
`in part because
`
`the active
`
`24
`
`25
`
`ingredients are different
`
`is that right
`
`MS. LEBEIS Objection to the extent
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`The Little Reporting Company
`646 650-5055 1 www.littlereporting.com
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`Page 226
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`227
`
`STEPHEN G. DAVIES D.PHIL.
`
`it mischaracterizes prior testimony.
`
`A
`
`They have different active
`
`ingredients and they have many other things
`
`that are different as well.
`
`Q
`
`So in your view you cant
`
`learn
`
`anything about one from the other
`
`is that
`
`right
`
`MS. LEBEIS Objection to the extent
`
`it mischaracterizes prior testimony.
`
`Asked
`
`and answered.
`
`A
`
`I dont
`
`think you can make a
`
`comparison between
`
`them.
`
`Q
`
`Is there anything you can learn from
`
`one of
`
`these examples that would be relevant
`
`to
`
`the other
`
`MS. LEBEIS Objection to the extent
`
`it mischaracterizes prior testimony. Calls
`
`for speculation.
`
`Asked and answered.
`
`A
`
`So many things. More than one thing
`
`has changed.
`So you cant make a direct comparison
`
`In fact several
`
`things have
`
`changed.
`
`between the two.
`
`Q
`
`Are you familiar with the textbook
`
`Remington
`
`The Science and Practice of
`
`The Little Reporting Company
`646 650-5055 1 www.littlereporting.com
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`Page 227
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`228
`
`STEPHEN G. DAVIES D.PHIL.
`
`Pharmacy
`
`A
`
`Q
`
`I
`
`know of
`
`it
`
`yes.
`
`Its a well-known reference in the
`
`field of pharmaceutical
`
`formulation
`
`MS. LEBEIS Objection. Calls for
`
`speculation.
`
`A
`
`Q
`
`It
`
`is a textbook in that
`
`field yes.
`
`Its a recognized authority in
`
`pharmaceutical
`
`science right
`
`MS. LEBEIS Objection. Calls for
`
`speculation.
`
`Asked and answered.
`
`A
`
`Q
`
`Its a textbook within that
`
`field.
`
`You dont
`
`think its a recognized
`
`authority
`
`MS. LEBEIS Objection to the extent
`
`it mischaracterizes prior testimony.
`
`Asked
`
`and answered.
`
`A
`
`Q
`
`Its a textbook within that
`
`field.
`
`But you disagree that
`
`its a
`
`recognized authority in pharmaceutical
`
`science
`
`MS. LEBEIS Objection to the extent
`
`it mischaracterizes prior testimony.
`
`Asked
`
`and answered.
`
`A
`
`Its one of several
`
`textbooks
`
`that
`
`The Little Reporting Company
`646 650-5055
`www.littlereporting.com
`
`Page 228
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`229
`
`STEPHEN G. DAVIES D.PHIL.
`
`are in the field.
`
`Q
`
`Its a leading pharmaceutical
`
`textbook
`
`right
`
`MS. LEBEIS Objection to the extent
`
`it mischaracterizes prior testimony.
`
`Asked
`
`and answered.
`
`A
`
`Its one of several
`
`textbooks in the
`
`field.
`
`MS. RAPALINO
`
`Im going to ask the
`
`court reporter
`
`to mark as Davies Exhibit
`
`10
`
`an excerpt
`
`from the 20th edition of
`
`Remington
`
`The Science and Practice of
`
`Pharmacy.
`
`Exhibit 10 was marked for
`
`identification and attached to the deposition
`
`transcript.
`
`BY MS. RAPALINO
`
`Q
`
`You would agree that
`
`a person of
`
`ordinary skill
`
`in the art would be familiar
`
`with the Remingtons
`
`textbook right
`
`MS. LEBEIS Objection. Calls for
`
`speculation.
`
`A
`
`Q
`
`I expect
`
`they would have heard of
`
`it.
`
`And it would be a textbook theyd
`
`The Little Reporting Company
`646 650-5055 1 www.littlereporting.com
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`Page 229
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`230
`
`STEPHEN G. DAVIES D.PHIL.
`
`consult
`
`in the course of doing their work in
`
`pharmacy
`
`MS. LEBEIS Objection. Calls for
`
`speculation.
`
`A
`
`Q
`
`They may or may not.
`
`If
`
`you turn to page 831 and the
`
`excerpt
`
`from Remingtons
`
`in Exhibit 10.
`
`A
`
`Q
`
`Yes.
`
`You see theres a section entitled
`
`Quaternary Ammonium Compounds
`
`A
`
`Q
`
`I see that.
`
`And Remington states that
`
`Benzalkonium chloride is a typical quaternary
`
`ammonium compound and is by far the most common
`
`preservative used in ophthalmic preparations.
`Do you see that
`
`A
`
`Q
`
`Thats what
`
`it
`
`says.
`
`You dont disagree that BAC is by far
`
`the most common preservative used in ophthalmic
`
`preparations
`
`do you
`
`MS. LEBEIS Objection. Calls for
`
`speculation.
`
`A
`
`Q
`
`I havent
`
`done the analysis.
`
`So you dont have a basis to disagree
`
`The Little Reporting Company
`646 650-5055 1 www.littlereporting.com
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`Page 230
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`STEPHEN G. DAVIES D.PHIL.
`
`with Remingtons
`
`MS. LEBEIS Objection. Calls for
`
`speculation.
`
`Asked and answered.
`
`231
`
`A
`
`It doesnt give me anything to go by
`done the analysis so I dont
`
`and I havent
`
`know whether
`
`its correct or not.
`
`Q
`
`And Remingtons also states that
`
`Over
`
`65 percent of commercial ophthalmic
`
`products are preserved with benzalkonium
`
`chloride.
`
`A
`
`Q
`
`Do you see that
`Thats what
`
`it says.
`
`And then Remingtons
`
`goes on to say
`
`that Despite this broad use the compound
`
`has
`
`definite limitations.
`
`Do you see that
`Thats what
`
`it says.
`
`Could you read the next sentence in
`
`A
`
`Q
`
`Remingtons.
`As a cationic surface active
`
`A
`
`material of high molecular weight
`
`it
`
`is not
`
`compatible with anionic compounds.
`
`Q
`
`So how would a person of skill
`
`in the
`
`art understand that sentence
`
`The Little Reporting Company
`646 650-5055 1 www.littlereporting.com
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`Page 231
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`232
`
`STEPHEN G. DAVIES D.PHIL.
`its saying that
`
`theres
`
`Well
`
`A
`
`supposed to be supposedly an incompatibility
`
`between
`
`the benzalkonium and anionic compounds.
`
`But again theres no evidence being put
`
`forward to that effect.
`
`The examples that are
`
`given are with salicylates and nitrates but
`
`again no reference.
`
`Q
`
`In your opinion would a person of
`
`skill
`
`in the art
`
`ignore this explicit guidance
`
`from Remingtons
`
`regarding incompatibility of
`
`benzalkonium chloride and anionic compounds
`
`MS. LEBEIS Objection.
`
`Mischaracterizes the document.
`
`Argumentative.
`
`A
`
`Well without encountering a problem
`
`they wouldnt be looking at
`
`this.
`
`So you do an
`
`experiment and if
`
`you see a problem maybe you
`
`would go out and look for some explanation.
`
`But
`
`I havent
`
`seen any evidence
`
`that
`
`there is a
`
`problem.
`
`Q
`
`If
`
`a person of skill
`
`in the art
`
`formulating an NSAID reviewed this section of
`
`Remingtons
`
`is it your opinion that
`
`they would
`
`ignore this guidance
`
`regarding the
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`233
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`STEPHEN G. DAVIES D.PHIL.
`
`incompatibility of anionic compounds with
`
`benzalkonium chloride
`
`MS. LEBEIS Objection to the extent
`
`it mischaracterizes prior testimony
`
`mischaracterizes the document.
`
`A
`
`They would do the experiment
`
`to see
`
`what happened.
`
`Q
`
`They would have to check
`
`to see
`
`whether
`
`there was an incompatibility right
`
`MS. LEBEIS Objection to the extent
`
`it mischaracterizes prior testimony.
`
`Argumentative.
`
`A
`
`They would do the experiment
`
`and all
`
`the experiments that have been done so far that
`
`I have seen dont
`
`show a problem of
`
`the
`
`benzalkonium ammonium and the NSAID.
`Im going to ask the
`
`MS. RAPALINO
`
`court
`
`reporter
`
`to mark as Davies Exhibit
`
`11
`
`an excerpt
`
`from the declaration of Shirou
`
`Sawa submitted in IPR 2015-902 and IPR
`
`2015-903.
`
`Exhibit 11 was marked for
`
`identification and attached to the deposition
`
`transcript.
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`The Little Reporting Company
`646 650-5055
`www.littlereporting.com
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`STEPHEN G. DAVIES D.PHIL.
`
`MS. RAPALINO
`
`For
`
`the record thats
`
`Exhibit
`
`-- Senju Exhibit 2098
`
`in those
`
`234
`
`IPRs.
`
`BY MS. RAPALINO
`
`Q
`
`Dr. Davies you participated as an
`
`expert
`
`in inter partes review proceedings
`
`for
`
`some of
`
`the patents-in-suit right
`
`A
`
`Q
`
`Can you repeat
`
`the question.
`
`Youve participated as an expert
`
`in
`
`inter partes review proceedings for some of
`
`the
`
`patents-in-suit
`
`in this case right
`
`A
`
`I said early on today that
`
`I didnt
`
`know what
`
`that meant.
`
`So Ive participated in
`
`12
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`18
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`--17A
`
`patent office proceedings.
`
`Q
`
`Okay.
`
`So you participated in
`
`Ive never heard them called what you
`
`-- what youve just said.
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`Q
`
`Understood.
`
`Let me use that
`
`terminology.
`
`So youve participated in patent
`
`office proceedings regarding the
`
`patents-in-suit
`
`in this case right
`
`A
`
`Q
`
`I have yes.
`
`You submitted one or more
`
`declarations
`
`in those patent office
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`The Little Reporting Company
`646 650-5055
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`235
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`STEPHEN G. DAVIES D.PHIL.
`
`proceedings
`
`A
`
`Q
`
`Yes I have yes.
`
`Have you reviewed a declaration
`
`submitted by one of
`
`the inventors in -- one of
`
`the inventors of
`
`the patents-in-suit Mr. Sawa
`
`A
`
`Ive reviewed this one before yes.
`
`So I may have misspoken earlier then because
`
`I
`
`didnt understand what
`
`IPR was when I said I
`
`hadnt
`
`read anything in the I
`
`-- well as far
`
`as I knew I hadnt but now you explained it.
`
`I have seen this one.
`
`Q
`
`Understood.
`
`We wont hold that
`
`against you.
`
`I
`
`know we use some complicated
`
`acronyms to talk about
`
`those patent office
`
`proceedings.
`
`Okay.
`
`So if
`
`you look at page 2 of
`
`this translation of Davies Exhibit
`
`10 -- do we
`
`have 10
`
`MS. LEBEIS
`11 Im sorry.
`
`I
`
`Q
`
`think its 11.
`
`11.
`
`You understand that Mr. Sawa who
`
`submitted this declaration is the first
`
`named
`
`inventor
`
`on one or more of
`
`the patents-in-suit
`
`A
`
`Yes.
`
`The Little Reporting Company
`646 650-5055
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`Page 235
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`236
`
`STEPHEN G. DAVIES D.PHIL.
`you turn to page 3 you see that
`in paragraph 7 he attests that he
`
`If
`
`Q
`
`he --
`
`prepared and tested the stability of bromfenac
`
`sodium formulations and he references Appendix
`
`A for that
`
`testing.
`
`Do you see that
`
`MS. LEBEIS Objection.
`
`Mischaracterizes the document.
`
`A
`
`Well
`
`he says the specific
`
`formulation is disclosed in table 1 of
`
`the 431
`
`and 290 patents.
`
`Q
`
`Right.
`
`And then he goes on to
`
`reference Appendix A in the next sentence.
`
`Do
`
`you see that
`
`MS. LEBEIS Objection.
`
`Mischaracterizes the document.
`
`A
`
`Well
`
`theres a lot of other words in
`
`between
`
`there about what actually they looked
`
`at but
`
`Q
`
`it does say Appendix A.
`you look at paragraph 8 the
`
`Then
`
`if
`
`19
`
`20
`
`21
`
`23
`
`--22A
`
`following paragraph
`
`Yes.
`
`Q
`
`-- he says As reflected in the
`
`24
`
`25
`
`laboratory notebook of Appendix A.
`
`the
`
`stability of
`
`these bromfenac
`
`sodium
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`Page 236
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`--6A
`
`STEPHEN G. DAVIES D.PHIL.
`
`formulations was tested after adjusting the pH
`
`of
`
`the formulations to 7.
`
`237
`
`Do you see that
`
`MS. LEBEIS Objection
`
`I see that.
`
`MS. LEBEIS
`
`-- mischaracterizes the
`
`document.
`
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`25
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`Q
`
`So do you understand that hes
`
`characterized Appendix A as a laboratory
`
`notebook
`
`MS. LEBEIS Objection.
`
`Mischaracterizes the document.
`
`A
`
`Well
`
`its not a laboratory notebook.
`
`It might be a translation of a laboratory
`
`notebook.
`
`Q
`
`Okay.
`
`So Appendix A is a translation
`
`of a laboratory notebook.
`
`A
`
`I dont
`
`know that.
`
`Thats what
`
`this
`
`says.
`
`Q
`
`So you think that Mr. Sawa is
`
`mistaken here in his declaration
`
`A
`
`No I
`
`Mischaracterizes --
`
`to the extent
`
`it
`
`The Little Reporting Company
`646 650-5055 1 www.littlereporting.com
`
`--24MS. LEBEIS Objection.
`
`Page 237
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`238
`
`STEPHEN G. DAVIES D.PHIL.
`
`mischaracterizes prior testimony
`
`argumentative.
`
`A
`
`I
`
`think youre asking me do I know
`
`its a translation of a laboratory notebook.
`
`I
`
`dont
`
`know other than what Mr. Sawa says.
`
`No to be clear my question was do
`Q
`you see that hes characterized Appendix A as a
`
`laboratory notebook
`
`MS. LEBEIS Objection to the extent
`
`it mischaracterizes the document.
`
`A
`
`He is suggesting that Appendix A is a
`
`laboratory notebook
`yes.
`So lets look at Appendix A which
`
`Q
`
`starts at page 28 of
`
`this excerpt.
`
`A
`
`Q
`
`A
`
`Q
`
`Sorry page
`
`28.
`
`28 okay.
`
`And if we look -- and you see that
`
`page 28 is the beginning of Appendix A. right
`
`A
`
`Yes.
`
`Then
`
`if
`
`you look at page 30
`
`in
`
`Okay.
`
`25
`
`Q
`
`-- you see that
`
`the top of
`
`the page
`
`The Little Reporting Company
`646 650-5055 1 www.littlereporting.com
`
`22
`
`23
`
`Q
`
`Appendix A
`
`--24A
`
`Page 238
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`239
`
`STEPHEN G. DAVIES D.PHIL.
`
`-- well
`
`first of all
`
`the page is dated
`
`February of 2000 right
`
`A
`
`Q
`
`February of 2000 yes.
`
`And there is a name of
`
`the test here.
`
`the formulation of Bronuck
`
`It says Study of
`ophthalmic solution at pH 7.
`Do you see that
`
`A
`
`Q
`
`Yes.
`
`Do you understand that Bronuck is a
`
`formulation of bromfenac sodium
`
`A
`
`Q
`
`Yes.
`
`And you see that
`
`the study director
`
`listed here on this page is Shirou Sawa right
`
`A
`
`Q
`
`Thats correct.
`
`Thats the inventor
`
`on the
`
`patents-in-suit right
`
`A
`
`Q
`
`Yes.
`
`And you see that
`
`in the paragraph in
`
`the middle of
`
`the page that start with the word
`
`20
`
`21
`
`--22A
`
`Purpose
`
`Yes.
`
`23
`
`24
`
`25
`
`Q
`
`-- he writes five lines from the
`
`bottom of
`
`that paragraph Although the
`
`addition of counterions to control
`
`the acetic
`
`The Little Reporting Company
`646 650-5055 1 www.littlereporting.com
`
`Page 239
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`240
`
`STEPHEN G. DAVIES D.PHIL.
`
`acid group has been considered bromfenac
`
`sodium forms insoluble complexes due to the
`
`addition of quaternary ammonium salt and
`
`becomes cloudy.
`
`A
`
`Q
`
`I see that.
`
`So do you understand that Mr. Sawa
`
`the inventor understood that bromfenac
`
`sodium
`
`forms insoluble complexes with the addition of
`
`a quaternary ammonium salt
`
`MS. LEBEIS Objection. Calls for
`
`speculation.
`
`A
`
`I dont agree with that.
`
`So thats
`
`not what
`
`he says.
`
`Q
`
`How do you understand what Mr. Sawa
`
`is saying in this declaration
`
`A
`
`Well
`
`first of all
`
`this is a
`
`laboratory notebook apparently of one of
`
`the
`
`inventors which I dont
`
`think is normally
`
`regarded as part of
`
`the common general
`
`knowledge.
`
`And what
`
`this actually says is that
`
`a precipitate --
`
`the solution becomes cloudy
`
`due to the addition of a quaternary ammonium
`
`salt does not mean that
`
`the quaternary ammonium
`
`salt
`
`is part of
`
`the precipitate.
`
`So unless
`
`The Little Reporting Company
`646 650-5055
`1 www.littlereporting.com
`
`Page 240
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`241
`
`STEPHEN G. DAVIES D.PHIL.
`
`Mr. Sawa Dr. Sawa actually analyzed the
`
`precipitate theres no way of knowing that
`
`its -- contains
`
`the quaternary ammonium salt.
`
`Q
`
`Okay.
`
`So you understand Mr. Sawa
`
`just to be saying that
`
`in a formulation
`
`containing bromfenac sodium the addition of
`
`the quaternary ammonium salt -- after addition
`
`of
`
`the quaternary ammonium salt
`complexes were formed but he didnt know what
`
`insoluble
`
`those complexes were.
`
`Is that what
`
`-- how you
`
`understand that
`
`MS. LEBEIS Objection to the extent
`
`it mischaracterizes prior testimony.
`
`A
`
`He doesnt
`
`know that.
`
`He doesnt
`
`know what
`
`they are and he doesnt
`
`know that
`
`they contain the quaternary ammonium salt.
`
`Q
`
`Okay.
`
`But you would agree that
`
`Mr. Sawa does know that when you formulate
`
`bromfenac
`
`sodium and benzalkonium chloride in a
`
`formulation the formulation becomes cloudy
`
`MS. LEBEIS Objection to the extent
`
`it mischaracterizes prior testimony and to
`
`the extent
`
`it mischaracterizes the
`
`document.
`
`The Little Reporting Company
`646 650-5055 I www.littlereporting.com
`
`Page 241
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`242
`
`STEPHEN G. DAVIES D.PHIL.
`
`A
`
`I can only repeat what
`
`Ive said.
`
`There is no evidence
`
`that any cloudiness
`
`involves the interaction of
`
`the benzyl ammonium
`
`cation with anything.
`
`Q
`
`Right.
`
`But
`
`there is evidence
`
`from
`
`this declaration of cloudiness
`
`in a bromfenac
`
`formulation that contains benzalkonium
`
`chloride right
`
`MS. LEBEIS Objection to the extent
`
`it mischaracterizes
`
`the document.
`
`A
`
`Well actually theres no evidence
`
`that bromfenac
`
`is involved in the cloudiness
`
`either.
`
`There is evidence
`
`that
`
`the solution
`
`goes -- his observation is the solution goes
`
`cloudy but he provides no evidence that
`
`bromfenac has anything to do with the
`
`cloudiness or that
`
`the benzyl ammonium has
`
`anything to do with the cloudiness.
`
`Q
`
`Okay.
`
`So he has a formulation that
`
`contains bromfenac and benzalkonium chloride
`
`and sees that
`
`it goes cloudy
`
`right
`
`MS. LEBEIS Objection to the extent
`
`it mischaracterizes the document.
`
`A
`
`He has a formulation that contains
`
`The Little Reporting Company
`646 650-5055
`1 www.littlereporting.com
`
`Page 242
`
`
`
`STEPHEN G. DAVIES D.PHIL.
`
`243
`
`those two and sees
`
`it
`
`if
`
`go cloudy yes.
`
`you turn the page to
`
`1
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`2
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`4
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`6
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`25
`
`page 33--5A
`
`In fact
`
`Okay.
`
`Q
`
`Q
`
`--
`
`there is a table there that
`
`reports the results of his observations of
`
`these formulations right
`
`Do you see that
`
`MS. LEBEIS Objection to the extent
`
`it mischaracterizes the document.
`
`A
`
`I dont
`
`know how do I know thats
`
`related to that experiment.
`
`Document
`review.
`Im trying to see how I know whatever
`
`the analysis is on page 33 has to do with the
`
`experiment.
`
`Q
`
`So you dont
`
`think that whats on
`
`page 33 has to do with the bromfenac
`
`formulation
`
`MS. LEBEIS Objection to the extent
`
`it mischaracterizes prior testimony and to
`
`the extent
`
`it mischaracterizes the
`
`document.
`
`A
`
`Okay.
`
`It would appear
`
`to be from
`
`that experiment.
`
`The Little Reporting Company
`646 650-5055
`www.littlereporting.com
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`Page 243
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`244
`
`STEPHEN G. DAVIES D.PHIL.
`
`Q
`
`And you see that
`
`in the chart on
`
`page 33 there are columns labeled Turbidity
`and Foreign Insoluble Matter
`
`A
`
`Q
`
`Yes.
`
`Those columns --
`
`the results in those
`
`columns suggest
`
`that
`
`the formulations of
`
`bromfenac
`
`--
`
`the formulations containing
`
`bromfenac
`
`and benzalkonium chloride show
`
`turbidity and show the presence of
`
`foreign
`
`insoluble matter right
`
`MS. LEBEIS Objection to the extent
`
`it mischaracterizes
`
`the document.
`
`A
`
`What
`
`I recall
`
`is that
`
`theyre labeled
`
`Turbidity and Foreign Insoluble Matter
`
`yes with plus and minuses.
`
`Q
`
`Right.
`
`So in nearly every one of
`
`those formulations there was
`
`--
`
`in nearly
`
`every one of
`
`the results reported in that
`
`table
`
`there was the presence of turbidity and the
`
`presence of
`
`foreign insoluble matter right
`
`MS. LEBEIS Objection to the extent
`
`it mischaracterizes the document.
`
`A
`
`Well with a little data available to
`
`go on that would appear
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`to be the case.
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`STEPHEN G. DAVIES D.PHIL.
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`Theres also quite a lot of color change
`
`I
`
`see.
`
`Q
`
`Lets go back
`
`to Davies Exhibit 1.
`
`Thats your expert report.
`
`And if
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`you would
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`turn please to paragraph 26.
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`A
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`Q
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`Yes.
`
`You say in the first
`
`sentence of
`
`paragraph 26 that The sodium salt of bromfenac
`
`is freely water soluble right
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`Do you see
`
`that
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`A
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`Q
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`I see that.
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`And you conclude
`
`that -- at
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`the end
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`of
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`that sentence that Thus any solubilizing
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`effect of polysorbate 80 or tyloxapol would not
`
`be required to dissolve or solubilize bromfenac
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`sodium right
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`A
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`Q
`
`Thats what
`
`I say yes.
`
`You would agree that
`
`the solubility
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`of
`
`the salt depends
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`on the nature of both the
`
`anion and the cation right
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`MS. LEBEIS Objection.
`
`Incomplete
`
`hypothetical.
`
`A
`
`If
`
`you take a particular salt of a
`
`particular anion and cation then the
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`1 www.littlereporting.com
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`246
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`STEPHEN G. DAVIES D.PHIL.
`
`solubility overall would depend on some balance
`
`between
`
`the two.
`
`Q
`
`So the solubility for example of
`
`bromfenac
`
`sodium would be different
`
`from the
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`solubility of a salt of bromfenac
`
`and
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`benzalkonium ion right
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`MS. LEBEIS Objection incomplete
`
`hypothetical.
`
`A
`
`Without experimentation I cant
`
`answer
`
`that.
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`Q
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`So you dont
`
`know whether
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`the
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`solubilities would be the same or different
`
`MS. LEBEIS Objection to the extent
`
`it mischaracterizes prior testimony.
`
`Incomplete hypothetical.
`
`A
`
`Well what
`
`I know is that sodium
`
`bromfenac
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`is freely water soluble.
`
`So both the
`
`anion and the cation of
`
`that are likely to be
`
`highly solvated and thats what makes the salt
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`soluble freely solid.
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`I dont
`
`know about
`
`--
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`I
`
`know that benzyl ammonium salts are soluble in
`
`water but
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`I dont
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`know to what extent relative
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`to sodium.
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`Q
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`Benzalkonium ion is more hydrophobic
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`247
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`STEPHEN G. DAVIES D.PHIL.
`
`than sodium right
`
`MS. LEBEIS Objection incomplete
`
`hypothetical. Calls for speculation.
`
`A
`
`Q
`
`Its more hydrophobic yes.
`
`And benzalkonium has alkyl chains in
`
`its structure right
`
`A
`
`Q
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`right
`
`It does yes.
`
`And alkyl chains are hydrophobic
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`MS. LEBEIS Objection incomplete
`
`hypothetical.
`
`A
`
`They are and the plus charge is
`
`hydrophilic.
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`Q
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`These formulations -- strike that.
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`13
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`19
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`--18Davies Exhibit 12.
`
`Why dont we
`
`look at U.S. Patent
`
`4910225 which we will mark as Exhibit
`
`Exhibit
`
`12 was marked for
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`identification and attached to the deposition
`
`transcript.
`
`BY MS. RAPALINO
`
`Q
`
`This is a patent
`
`you reviewed in
`
`connection with rendering your opinions in this
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`case right
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`646 650-5055
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`STEPHEN G. DAVIES D.PHIL.
`
`It
`
`is yes.
`
`You understand that experimental
`
`A
`
`Q
`
`example 6 at column 8 of
`
`this 225 patent at
`
`Exhibit
`
`12 contains
`
`the same ingredients as the
`
`Bronuck bromfenac
`
`sodium product
`
`MS. LEBEIS Objection. Calls for
`
`speculation.
`
`A
`
`I havent actually compared them so I
`
`dont
`
`know that.
`
`Q
`
`Actually I
`
`think I misspoke.
`
`Its
`
`example 6 at column 10 of
`
`the 225 patent
`
`that
`
`has the same ingredients as the Bronuck
`
`product.
`
`that
`
`A
`
`Q
`
`Have
`
`you had a chance to look at
`
`No.
`
`You would agree that
`
`the Bronuck
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`bromfenac product contained polysorbate 80 as
`
`one of
`
`its components
`
`right
`
`MS. LEBEIS Objection. Calls for
`
`speculation.
`
`Asked and answered.
`
`A
`
`I havent
`
`reviewed in detail
`
`the
`
`ingredients of
`
`the bromfenac patent.
`
`So what
`
`were you asking me to compare
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`The Little Reporting Company
`646 650-5055 1 www.littlereporting.com
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`Page 248
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`249
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`STEPHEN G. DAVIES D.PHIL.
`
`Q
`
`Oh I was asking about
`
`the Bronuck
`
`formulation.
`
`A
`
`Bronuck.
`
`I havent
`
`reviewed in
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`detail.
`
`Q
`
`Youre familiar with the Bronuck
`
`product
`
`that
`
`there was a Bronuck product
`
`on
`
`the market
`
`in Japan as of 2003
`
`MS. LEBEIS Objection no
`
`foundation.
`
`I know that
`
`--
`
`I dont
`
`know the date
`
`know that Bronuck contains bromfenac.
`
`And that was a commercial product
`
`in
`
`but
`
`A
`
`I
`
`Q
`
`Japan
`
`MS. LEBEIS Objection no
`
`foundation.
`
`Asked and answered.
`
`A
`
`Q
`
`I dont
`
`know that.
`
`Lets look at example 6 of
`
`the 225
`
`patent.
`
`This is at column 10.
`
`Are you there
`
`A
`
`Yes.
`
`You see that
`
`Q
`contains polysorbate 80
`
`that
`
`formulation
`
`A
`
`Q
`
`A
`
`It does yes.
`
`Whats the -- what
`
`is polysorbate 80
`
`Its a --
`
`I drew a picture of
`
`it
`
`in
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`The Little Reporting Company
`646 650-5055 1 www.littlereporting.com
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`Page 249
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`STEPHEN G. DAVIES D.PHIL.
`
`my review.
`
`Its a polyethoxylated derivative
`
`of sorbic acid.
`
`Q
`
`Its used as a surfactant right
`
`MS. LEBEIS Objection incomplete
`
`hypothetical.
`
`A
`
`You have to look at
`
`the particular
`
`case where its employed as to whether
`
`its
`
`been a surfactant or not.
`
`Q
`
`Have you seen polysorbate 80 used in
`
`pharmaceutical
`
`formulations for some other
`
`purpose
`
`MS. LEBEIS Objection. Calls for
`
`speculation.
`
`No foundation.
`
`A
`
`Q
`
`I havent
`
`done that analysis.
`
`But youre aware that polysorbate 80
`
`is used in a surfactant
`
`MS. LEBEIS Objection to the extent
`
`it mischaracterizes prior testimony.
`
`No
`
`foundation.
`
`A
`
`In some instances
`
`it
`
`has been yes.
`
`But
`
`in this particular patent
`
`I dont recall
`
`any -- any comment
`
`as to why they put
`
`polysorbate 80 into these formulations.
`
`Q
`
`And in your view a person of skill
`
`The Little Reporting Company
`646 650-5055
`1 www.littlereporting.com
`
`Page 250
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`
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`251
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`STEPHEN G. DAVIES D.PHIL.
`
`in the art wouldnt
`
`know what
`
`the function was
`
`of polysorbate 80 in these formulations is
`
`that right
`
`MS. LEBEIS Objection to the extent
`
`it mischaracterizes prior testimony.
`
`I would expect
`
`to be informed
`
`informed.
`
`So I dont
`
`know why they
`
`Well
`A
`Im not
`
`it
`
`in there.
`
`but
`
`put
`
`Q
`
`So a person of skill
`
`in the art
`
`wouldnt
`
`know what polysorbate 80 was doing in
`
`the formulation
`
`A
`
`Well
`
`since they dont
`
`tell you you
`
`cant
`
`tell why they put
`
`it
`
`in there.
`
`Q
`
`A person of skill
`
`in the art couldnt
`
`look at
`
`the literature that was available as of
`
`the time of
`
`the patent
`
`to determine the
`
`function of an excipient
`
`like polysorbate 80
`
`MS. LEBEIS Objection. Calls for
`
`speculation to the extent
`
`it
`
`mischaracterizes prior testimony asked and
`
`answered.
`
`A
`
`The author of
`
`the patents doesnt
`
`--24dont
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`tell
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`you why they put
`in there so you cant be sure.
`
`the polysorbate 80
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`The Little Reporting Company
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`Page 251
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`STEPHEN G. DAVIES D.PHIL.
`
`Q
`
`So you dont
`
`know why it was put
`
`in
`
`252
`
`there
`
`A
`
`Q
`
`I dont
`
`know why no.
`
`So in your view a person of skill
`
`in the art would have known that bromfenac
`
`sodium was relatively water soluble
`
`MS. LEBEIS Objection to the extent
`
`it mischaracterizes prior testimony.
`
`A
`
`Would you like to repeat
`
`the
`
`question.
`
`MS. RAPALINO
`
`Could you read that
`
`back please.
`
`BY MS. RAPALINO
`
`Q
`
`But
`
`in your view a person of
`
`ordinary skill
`
`in the art would have known
`
`that
`
`bromfenac
`
`sodium was relatively water soluble
`
`MS. LEBEIS Objection to the extent
`
`The Little Reporting Company
`646 650-5055 1 www.littlereporting.com
`
`--19MS. LEBEIS
`
`Record read.
`
`MS. LEBEIS Objection