throbber
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`111
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`STEPHEN G. DAVIES D.PHIL.
`
`why would they need to discuss anything about
`
`the structure.
`
`Q
`
`So you would agree with me that
`
`in
`
`the context of this patent discussion of
`
`the
`
`problem of NSAID-BAC complexation theres no
`
`discussion of
`
`the degree of
`
`lipophilicity of
`
`different NSAIDs
`
`right
`
`MS. LEBEIS Objection.
`
`Mischaracterizes the document
`
`asked and
`
`answered and to the extent
`
`it
`
`mischaracterizes prior testimony.
`
`A
`
`Theres no reason why they would
`
`discuss the lipophilicity -- about
`
`a problem
`
`that
`
`they dont experience.
`
`Q
`
`In talking generally about
`
`the
`
`problem of NSAID-BAC complexation whether or
`
`not
`
`its experienced in this patent
`
`the
`
`authors of
`
`the patent dont discuss differences
`
`in lipophilicity between different NSAIDs is
`
`that right
`
`MS. LEBEIS Objection same
`
`objections.
`
`A
`
`Well
`
`I dont
`
`think that
`
`Ive seen
`
`any evidence
`
`that
`
`the problem exists anywhere
`
`The Little Reporting Company
`646 650-5055 I www.littlereporting.com
`
`Lupin EX1103-B
`
`Page 111
`
`

`
`STEPHEN G. DAVIES D.PHIL.
`
`let alone in this patent
`
`so
`
`Again Dr. Davies were going to be
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`112
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`here a
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`long time if
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`--3Q
`
`you dont answer my
`So Ive heard you testify now that
`
`questions.
`
`you dont believe theres a problem.
`Im trying to get you to answer
`Im asking you.
`MS. LEBEIS Counsel hes answering
`
`that.
`
`questions
`
`We got
`
`the
`
`your questions.
`
`Q
`
`And again my question to you is
`
`that
`
`in the context of
`
`this paragraph thats
`
`discussing a general problem of NSAID-BAC
`
`complexation is there any discussion in this
`
`patent
`
`in that section of differences
`
`between
`
`NSAIDs
`
`in terms of their lipophilicity
`
`MS. LEBEIS Objection asked and
`
`answered. Mischaracterizes the document
`
`and mischaracterizes
`
`--
`
`to the extent
`
`it
`
`mischaracterizes prior testimony.
`
`A
`
`Theres no discussion because
`
`theres
`
`no problem experienced in this patent.
`
`Q
`
`And you would agree that
`
`in this
`
`paragraph that
`
`talks about
`
`the problem of
`
`NSAID-BAC complexation theres no discussion
`
`The Little Reporting Company
`646 650-5055 1 www.littlereporting.com
`
`Page 112
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`

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`STEPHEN G. DAVIES D.PHIL.
`
`of
`
`the degree of hydrogen bonding among
`
`different NSAIDs
`
`is that right
`
`MS. LEBEIS Objection.
`
`Mischaracterizes the document.
`
`A
`
`Theres no discussion because
`
`the
`
`problem isnt observed
`
`in this patent
`
`and
`
`thats not
`
`the aim of
`
`the patent.
`
`Q
`
`Now you would agree with me that
`
`113
`
`the
`
`were talking here about
`the Background of
`this 876 patent
`
`Invention section of
`
`right
`
`A
`
`Q
`
`Yes.
`
`And you would agree with me that
`
`the
`
`Background of
`
`the Invention section generally
`
`doesnt
`
`talk about problems that are -- or
`
`experimental data that are observed in the
`
`context of
`
`the patent
`
`right
`
`MS. LEBEIS Objection. Calls for a
`
`legal conclusion.
`
`Calls for speculation.
`
`A
`
`I would think that depends
`
`on patent
`
`to patent.
`
`Q
`
`Well certainly when you publish a
`
`paper when you have a background section of
`
`your paper
`
`thats not
`
`the section in which you
`
`report your experimental data right
`
`The Little Reporting Company
`646 650-5055
`1 www.littlereporting.com
`
`Page 113
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`

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`114
`
`STEPHEN G. DAVIES D.PHIL.
`
`MS. LEBEIS Objection.
`
`No
`
`foundation.
`
`A
`
`Q
`
`You might
`
`report
`
`the result.
`
`But generally that section is
`
`directed to concepts
`
`that are known in the
`
`background
`
`in the relevant
`
`field right
`
`MS. LEBEIS Objection no
`
`foundation.
`
`Asked and answered.
`
`A
`
`In one of my papers every statement
`
`we would make in the background section would
`
`have a reference to it
`
`to substantiate whatever
`
`comment we were making.
`
`Q
`
`And those would be comments or
`
`concepts
`
`that were known in the field already
`
`not new data that you generated in your
`
`laboratory right
`
`MS. LEBEIS Objection to the form of
`
`the question.
`
`Vague and ambiguous.
`
`No
`
`foundation.
`
`A
`
`I
`
`think we would try to put
`
`references
`
`to everything.
`
`Q
`
`And those references would reflect
`
`what was
`
`known in the field already prior to
`
`the publication at
`
`issue right
`
`The Little Reporting Company
`646 650-5055 1 www.littlereporting.com
`
`Page 114
`
`

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`115
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`STEPHEN G. DAVIES D.PHIL.
`
`MS. LEBEIS Objection.
`
`Asked and
`
`answered.
`
`Same objections.
`
`A
`
`It would be substantiating what we
`
`were saying in the background
`
`introduction
`
`section.
`
`Q
`
`And that background
`
`introduction
`
`section would detail
`
`information that was known
`
`in the relevant
`
`field right
`
`MS. LEBEIS Objection no
`
`foundation.
`
`Asked and answered.
`
`A
`
`It would show substantiate
`
`8
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`--13substantiatable data properly referenced
`--14describe substantiatable
`
`data with properly
`
`referenced.
`
`Q
`
`And again that substantiatable
`
`data properly referenced would be information
`
`that was
`
`known in the field right
`
`MS. LEBEIS
`
`Same objections.
`
`A
`
`We wouldnt be able to substantiate
`
`it
`
`if
`
`it wasnt
`
`known in the field.
`
`Q
`
`So it would be information that was
`
`known in the field then.
`
`MS. LEBEIS Objection.
`
`A
`
`It would be
`
`--TheLittle Reporting Company
`
`646 650-5055 I www.littlereporting.com
`
`Page 115
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`116
`
`STEPHEN G. DAVIES D.PHIL.
`
`MS. LEBEIS
`
`Same objections.
`
`A
`
`It would be known
`
`in the field
`
`because we could put
`
`a reference to it.
`
`Q
`
`So a person of ordinary skill
`
`in the
`
`art
`
`reading a patent would understand that
`
`the
`
`Background of
`
`the Invention section often
`
`sets forth information thats known in the
`
`field right
`
`MS. LEBEIS Objection to the extent
`
`it calls for a legal conclusion.
`
`Asked and
`
`answered. Calls for speculation.
`
`A
`
`I dont
`
`think thats necessarily
`
`true.
`
`So I havent
`
`seen any evidence
`
`in this
`
`case that
`
`there is a problem of an insoluble
`
`complex.
`
`Lets see if
`you can answer
`the
`Q
`question Im asking which is would a person
`in the art
`
`reading a background
`
`of skill
`
`section of a patent generally understand that
`
`that section will
`
`include information thats
`
`known in the field
`
`MS. LEBEIS Objection. Calls for a
`
`legal conclusion
`
`asked and answered and
`
`calls for speculation.
`
`The Little Reporting Company
`646 650-5055 1 www.littlereporting.com
`
`Page 116
`
`

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`117
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`STEPHEN G. DAVIES D.PHIL.
`Im not sure if
`
`its not
`
`referenced
`
`A
`
`they would be able to tell whether
`
`it was
`
`speculation or fact.
`
`Q
`
`So if
`
`a statement
`
`in a patent has no
`
`reference
`
`in your view a person of skill
`
`in
`
`the art would just
`
`read it
`
`and move on and not
`
`pay any attention to it.
`
`Is that your
`
`testimony
`
`--11A
`
`7
`
`8
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`9
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`10
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`12
`
`MS. LEBEIS Objection
`
`No.
`
`MS. LEBEIS
`
`--
`
`to the extent
`
`it
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`mischaracterizes prior testimony. Calls
`
`for a legal conclusion and speculation.
`
`A
`
`I
`
`think if
`
`a person of ordinary skill
`
`in the art knew references
`
`themselves that
`
`substantiated a statement
`
`then that would be
`
`fine.
`
`MS. RAPALINO
`
`Lets look at another
`
`reference if we could.
`
`Lets mark as
`
`Davies Exhibit
`
`3 U.S. Patent 5603929.
`
`Exhibit
`
`3 was marked for identification
`
`and attached to the deposition transcript.
`
`BY MS. RAPALINO
`
`Q
`
`Now Exhibit
`
`3
`
`is another U.S. patent
`
`The Little Reporting Company
`646 650-5055 1 www.littlereporting.com
`
`Page 117
`
`

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`118
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`
`STEPHEN G. DAVIES D.PHIL.
`
`that you considered in forming your opinions
`
`right
`
`A
`
`Q
`
`Yes.
`
`This patent
`
`indicates that
`
`the date
`
`of
`
`the patent
`
`is February 18th 1997 right
`
`A
`
`Q
`
`Thats what
`
`it says.
`
`The patent
`
`is entitled Preserved
`
`ophthalmic drug compositions
`
`containing
`
`polymeric quaternary ammonium compounds
`
`right
`
`A
`
`Q
`
`Yes.
`
`If
`
`you turn to column 1 of
`
`the 929
`
`patent Exhibit
`
`3
`
`Yes.
`
`--15A
`--18A
`
`12
`
`13
`
`14
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`16
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`17
`
`19
`
`Q
`
`-- and you look at
`
`the paragraph that
`
`begins at
`
`line 27
`
`Okay.
`
`Q
`
`-- you would agree that
`
`the patent
`
`20
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`21
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`22
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`23
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`24
`
`25
`
`reports that benzalkonium chloride is widely
`
`used in ophthalmic solutions right
`
`A
`
`Q
`
`Thats what
`
`it says yes.
`
`And it goes on in that paragraph in
`
`the next sentence to say that BAC and other
`
`quaternary ammonium compounds are generally
`
`The Little Reporting Company
`646 650-5055 1 www.littlereporting.com
`
`Page 118
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`

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`119
`
`STEPHEN G. DAVIES D.PHIL.
`
`considered incompatible with ophthalmic
`
`compositions of drugs with acidic groups like
`
`NSAIDs.
`
`Do you see that
`
`MS. LEBEIS Objection.
`
`Mischaracterizes the document.
`
`A
`
`Q
`
`It makes that general statement.
`
`And then it
`
`goes on to make the
`
`general statement
`
`that
`
`this is because
`
`the
`
`preservative BAC loses its ability to function
`
`because
`
`it
`
`forms complexes with the charged
`
`drug compounds.
`
`Do you see that
`
`MS. LEBEIS Objection.
`
`Mischaracterizes
`
`the document.
`
`A
`
`Its a general statement without any
`
`reference.
`
`Q
`
`And that general statement about BAC
`
`forming complexes with acidic NSAIDs
`
`is not
`
`limited to any particular NSAID right
`
`A
`
`Well
`
`it doesnt even give one
`
`example.
`
`Q
`
`Right.
`
`So its not
`
`limited to even
`
`one example right
`
`MS. LEBEIS Objection to the extent
`
`it mischaracterizes prior testimony.
`
`The Little Reporting Company
`646 650-5055 1 www.littlereporting.com
`
`Page 119
`
`

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`120
`
`STEPHEN G. DAVIES D.PHIL.
`
`Mischaracterizes the document.
`
`A
`
`It doesnt give any evidence that
`
`theres a problem with even one.
`
`Its just a
`
`general statement without any foundation.
`
`Q
`
`And that general statement
`
`is not
`
`limited to any particular NSAID.
`
`Its about
`
`NSAIDs generally right
`
`MS. LEBEIS Objection to the extent
`
`it mischaracterizes the document.
`
`Asked
`
`and answered.
`
`A
`
`Without even giving an example of one
`
`occurrence
`
`a person of ordinary skill would
`
`have -- wouldnt
`
`know on what basis that was
`
`being made.
`
`Q
`
`But you would agree that
`
`the general
`
`statement
`
`itself
`
`is not
`
`limited to any
`
`particular NSAID right
`
`MS. LEBEIS Objection to the extent
`
`it mischaracterizes prior testimony.
`
`Asked
`
`and answered.
`
`A
`
`This is not
`
`informing a person of
`
`ordinary skill of any instance where there
`
`actually is a problem between
`
`a carboxylic acid
`
`and NSAID and benzalkonium chloride.
`
`The
`
`The Little Reporting Company
`646 650-5055
`1 www.littlereporting.com
`
`Page 120
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`121
`
`STEPHEN G. DAVIES D.PHIL.
`
`actual patent
`
`itself
`
`is about preservative
`
`action again.
`
`Q
`
`And this general statement
`
`that we
`
`just looked at
`
`in column 1
`
`ties the formation
`
`of complexes between BAC and NSAIDs
`
`to the
`
`issue of preservatives
`
`losing their ability to
`
`function right
`
`MS. LEBEIS Objection.
`
`Mischaracterizes the document.
`
`A
`
`Well
`
`it doesnt give any evidence
`
`that thats true.
`
`There would be other ways
`
`that preservatives
`
`could lose their function.
`
`Q
`
`But
`
`this suggests that one way could
`
`be that
`
`the preservatives
`
`lose their ability to
`
`function as they form complexes with the
`right Thats what
`
`charged drug compounds
`
`it
`
`suggests
`
`MS. LEBEIS Objection.
`
`Mischaracterizes the document.
`
`A
`
`But since it doesnt give any
`
`examples where it actually happens
`
`its a
`
`meaningless statement.
`
`Q
`
`It may be true that complexes form
`
`which cause the preservatives
`
`to lose their
`
`The Little Reporting Company
`646 650-5055 1 www.littlereporting.com
`
`Page 121
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`122
`
`STEPHEN G. DAVIES D.PHIL.
`
`efficacy
`
`right
`
`MS. LEBEIS Objection to the extent
`
`it mischaracterizes prior testimony and
`
`asked and answered. Mischaracterizes the
`
`document.
`
`A
`
`Without any examples
`
`it may never be
`
`true.
`
`Q
`
`And it may be true right
`
`MS. LEBEIS Objection to the extent
`
`it mischaracterizes prior testimony.
`
`A
`
`Without examples
`
`you cannot
`
`just
`
`make the assumption. Otherwise you would have
`
`to assume millions of
`
`things billions of
`You need to have a problem thats
`
`things.
`
`concrete before you have to worry about
`
`it.
`
`Q
`
`But
`
`this patent at column 1 suggests
`
`that
`
`the problem of complexation leads to
`
`preservatives losing their ability to function
`
`right
`
`MS. LEBEIS Objection asked and
`
`answered. Mischaracterizes the document.
`
`A
`
`It suggests without any evidence
`
`that
`
`that might be the case but unless a person of
`
`ordinary skill
`
`sees the problem in reality
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`The Little Reporting Company
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`123
`
`STEPHEN G. DAVIES D.PHIL.
`
`then its irrelevant.
`
`Q
`
`But you cant
`
`know with certainty
`
`whether or not
`
`these complexes form without
`
`seeing the test data right
`
`MS. LEBEIS Objection.
`
`Vague and
`
`ambiguous.
`
`To
`
`the extent
`
`it
`
`mischaracterizes prior testimony.
`
`A
`
`You have -- you would not assume
`
`there was a problem until youve done
`
`a test
`
`and found the problem existed.
`
`Q
`
`You wouldnt
`
`know with certainty
`
`whether or not a complex formed between
`
`a
`
`particular NSAID and benzalkonium chloride
`
`until you saw the test data right
`
`A
`
`Sorry I missed the first part of
`
`that question.
`
`Record read.
`
`A
`
`You would not know no.
`
`the 929 patent
`In this patent
`Q
`Exhibit 3 there is no discussion in this
`
`section that
`
`talks about
`
`this potential problem
`
`of complexation about differences
`
`between
`
`NSAIDs
`
`in terms of their chemical structure
`
`right
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`The Little Reporting Company
`646 650-5055
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`
`STEPHEN G. DAVIES D.PHIL.
`
`MS. LEBEIS Objection no
`
`foundation. Mischaracterizes the document.
`
`A
`
`There isnt nor would one expect
`
`there to be when the problem isnt actually
`
`observed.
`
`Q
`
`Theres also no discussion in this
`
`section of
`
`the patent
`
`that
`
`talks about
`
`the
`
`potential problem of complexation between
`
`NSAIDs
`
`and BAC of
`
`the differences in electron
`
`density between different NSAIDs right
`
`MS. LEBEIS
`
`Same objections.
`
`A
`
`There isnt nor would a person of
`
`ordinary skill
`
`expect
`
`there to be when the
`
`problem isnt presented.
`
`Q
`
`Theres also no discussion in this
`
`929 patent of
`
`the differences between NSAIDs
`
`in terms of whether
`
`theyre primary secondary
`
`or tertiary amines as being relevant
`
`to this
`
`issue of potential complexation right
`
`MS. LEBEIS
`
`Same objection.
`
`A
`
`The patent
`
`is not about potential
`
`complexation so there would be no discussion.
`
`Q
`
`Theres also no discussion in this
`
`section of
`
`the patent
`
`that
`
`talks about
`
`the
`
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`125
`
`STEPHEN G. DAVIES D.PHIL.
`
`problem of potential complexation between
`
`NSAIDs and BAC of
`
`the differences between
`
`NSAIDs
`
`in terms of
`
`the presence or absence of
`
`halogenation on the compounds
`
`MS. LEBEIS Objection to the form of
`
`the question.
`
`A
`
`There wouldnt be because
`
`thats not
`
`the problem being addressed by the patent.
`
`Q
`
`And theres also no discussion in
`
`this patent
`
`in the section that
`
`talks about
`
`the potential complexation between NSAIDs and
`
`BAC about differences
`
`in lipophilicity between
`
`different NSAIDs right
`
`MS. LEBEIS Objection.
`
`Mischaracterizes the document.
`
`A
`
`I
`
`lost
`
`the end of
`
`the sentence
`
`end
`
`of
`
`the question.
`
`Record read.
`
`MS. LEBEIS Objection.
`
`A
`
`There isnt because
`
`its irrelevant
`
`to what
`
`the main part of
`
`the patent
`
`is about.
`
`Q
`
`And theres also no discussion in
`
`this patent
`
`in the section that
`
`talks about
`
`potential
`
`complexation between NSAIDs and BAC
`
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`
`STEPHEN G. DAVIES D.PHIL.
`
`of differences
`
`between NSAIDs
`
`in terms of their
`
`126
`
`degree of hydrogen bonding right
`
`MS. LEBEIS Objection.
`
`Mischaracterizes the document.
`
`A
`
`There wouldnt
`
`be because
`
`such facts
`
`are irrelevant
`
`to the rest of
`
`the patent and
`
`what
`
`its actually dealing with.
`
`What do you think this patent
`Q
`directed to this Exhibit 3 929 patent
`
`is
`
`MS. LEBEIS Objection vague and
`
`ambiguous.
`
`A
`
`Well
`
`the data thats presented has
`
`to do with preservative action.
`
`Q
`
`So this patent
`
`is directed to
`
`ophthalmic pharmaceutical
`
`compositions with
`
`good preservative efficacy
`
`MS. LEBEIS Objection to the extent
`
`it mischaracterizes
`
`the prior testimony and
`
`mischaracterizes the document.
`
`A
`
`As I said the data that
`
`is presented
`
`has to do with preservative action.
`
`Q
`
`A
`
`In what kind of
`
`formulations
`
`Document
`
`review.
`
`In diclofenac formulations.
`
`This is
`
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`127
`
`STEPHEN G. DAVIES D.PHIL.
`
`another one sulfacetamide and suprofen.
`
`Those
`
`three are formulated.
`
`Q
`
`So this patent provides
`
`a formulation
`
`thats suitable for use with those three
`
`compounds
`
`is that right
`
`MS. LEBEIS Objection.
`
`Mischaracterizes the document.
`
`A
`
`Document
`
`review.
`
`The results seem to be on formulation
`
`A. which is sodium diclofenac
`
`in terms of
`
`its
`
`preservation activity.
`
`Q
`
`In your view is the subject of
`
`the
`
`patent
`
`then limited to formulations of
`
`diclofenac sodium
`
`MS. LEBEIS Objection to the extent
`
`it mischaracterizes prior testimony.
`
`A
`
`Thats a legal question.
`
`Its not
`
`for me to say.
`
`But
`
`the data is only presented
`
`for as far as I can see for formulation A.
`
`which has diclofenac
`
`in it.
`
`Q
`
`So you dont have an opinion one way
`
`or another on whether
`
`this patent
`
`is limited to
`
`formulations of diclofenac sodium or includes
`
`other
`
`formulations
`
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`

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`128
`
`STEPHEN G. DAVIES D.PHIL.
`
`MS. LEBEIS Objection to the extent
`
`it mischaracterizes prior testimony.
`
`A
`
`The data presented and what
`
`a person
`
`of ordinary skill would see is data on sodium
`
`diclofenac.
`
`Q
`
`Now if we go back
`in column 1 starting at
`
`line 27.
`
`to the paragraph
`
`A
`
`Q
`
`Yes.
`
`So if
`
`you can
`
`keep that open and then
`
`go back to Exhibit 2.
`
`A
`
`Okay.
`
`And look at
`
`the paragraph we looked
`Q
`in column 1 of Exhibit 2 the 876 patent
`
`at
`
`that starts at
`
`line 10.
`
`1
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`16
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`18
`
`--17Q
`
`A
`
`A
`
`Starts at
`
`line
`
`10.
`
`10
`
`19
`
`20
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`21
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`22
`
`23
`
`24
`
`25
`
`Q
`
`A
`
`Column 1.
`
`Okay.
`
`Q
`
`the statements
`
`You would agree that
`in column 1 are
`in Exhibit 2 the 876 patent
`consistent with the statements in Exhibit 3
`the 929 patent at column 1
`MS. LEBEIS Objection to the form of
`
`The Little Reporting Company
`646 650-5055
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`Page 128
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`
`STEPHEN G. DAVIES D.PHIL.
`
`the question.
`
`Vague and ambiguous.
`
`A
`
`Theyre broadly consistent.
`
`Theyre
`
`from the same -- both patents are from the same
`
`company.
`
`Theres no evidence
`
`in either of
`
`them
`
`that
`
`theyre true or not.
`
`Q
`
`I
`
`think you pointed out
`
`theyre both
`
`from Alcon Laboratories Inc.
`
`right both of
`
`those patents
`
`A
`
`Thats correct.
`
`MS. RAPALINO
`
`Lets mark as Davies
`
`Exhibit
`
`4 European Patent 0306984.
`
`Exhibit 4 was marked for identification
`
`and attached to the deposition transcript.
`
`BY MS. RAPALINO
`
`Q
`
`Dr. Davies this is a European patent
`
`you considered in forming your opinions in this
`
`case
`
`A
`
`Q
`
`984
`
`Yes.
`
`Is it
`
`okay
`
`if
`
`we
`
`refer to that as EP
`
`A
`
`Thats fine.
`
`This patent has a date of publication
`Q
`of March of 89 is that right
`Thats correct
`
`yes.
`
`A
`
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`STEPHEN G. DAVIES D.PHIL.
`
`Q
`
`This patent
`
`is --
`
`indicates that
`
`the
`
`130
`
`applicant
`
`is Syntex Inc.
`
`right
`
`MS. LEBEIS Objection.
`
`Mischaracterizes the document.
`
`A
`
`Q
`
`It says Applicant Syntex Inc.
`Thats a separate company from Alcon
`
`Laboratories right
`
`MS. LEBEIS Objection. Calls for
`
`speculation.
`
`A
`
`Q
`
`I dont
`
`know.
`
`Well
`
`it doesnt
`
`list Alcon as the
`
`applicant
`
`right
`
`A
`
`It
`
`does not.
`
`MS. LEBEIS Objection
`
`argumentative.
`
`--20those on Exhibits 2 and 3 that we looked at
`
`15
`
`16
`
`17
`
`18
`
`19
`
`A
`
`Q
`
`It doesnt say Alcon.
`
`And the inventors listed on this
`
`patent are not
`
`the same inventors as the
`
`21
`
`earlier right
`
`22
`
`23
`
`24
`
`25
`
`A
`
`Q
`
`Theyre not
`Now if we look at page 2 of EP 984
`
`no.
`
`Exhibit 4.
`
`A
`
`Page 2.
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`Page 130
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`

`
`STEPHEN G. DAVIES D.PHIL.
`
`131
`
`Q
`
`A
`
`Q
`
`Page 2.
`
`Okay.
`
`You see that
`
`in the paragraph
`
`line 10 EP 984 describes
`beginning at
`earlier patent U.S. Patent 4454151
`
`an
`
`A
`
`Yes.
`
`MS. LEBEIS
`
`Is that
`
`a question
`
`Is
`
`there a question
`
`MS. RAPALINO
`
`Yes I
`
`think we just
`
`got an answer
`
`to it.
`
`A
`
`Q
`
`I see the patent
`
`number
`
`there yes.
`
`Yes.
`
`And then it
`
`goes on to say that
`
`While the formulations described in the 151
`
`patent were efficacious an insoluble complex
`
`was
`
`found to form between
`
`the NSAID and BAC.
`
`Do you see that
`
`Thats what
`
`it
`
`says.
`you go down to page 2 line
`
`And if
`
`Yes.
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`
`Q
`
`20
`
`--21A
`
`31
`
`22
`
`23
`
`24
`
`25
`
`Q
`
`-- you see theres a sentence that
`
`says Benzalkonium chloride a quaternary
`
`ammonium compound has been widely used in
`
`ophthalmic solutions and is considered to be
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`132
`
`STEPHEN G. DAVIES D.PHIL.
`the preservative of choice
`
`A
`
`Q
`
`Thats what
`
`it says.
`
`You dont disagree that benzalkonium
`
`chloride had been widely used in ophthalmic
`
`formulations and was a preservative of choice
`
`do you
`
`MS. LEBEIS Objection. Calls for
`
`speculation.
`
`A
`
`Q
`
`I havent
`
`done that analysis.
`
`So you dont have an opinion one way
`
`or another
`
`A
`
`Q
`
`Since I havent
`
`done the analysis.
`
`So you dont have an opinion one way
`
`or another
`
`MS. LEBEIS
`
`Asked and answered.
`
`A
`
`I havent
`
`done the analysis so I
`
`dont.
`
`I dont
`
`know.
`
`And I suspect
`
`it
`
`depends
`
`on the ophthalmic solution as what
`
`the
`
`preservative of choice is.
`
`Ive seen others
`
`that dont have the benzyl ammonium the
`
`quaternary ammonium compound.
`
`Q
`
`But you havent
`
`done the analysis one
`
`way or another
`
`to know when benzalkonium
`
`chloride would be a preservative of choice
`
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`Page 132
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`STEPHEN G. DAVIES D.PHIL.
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`133
`
`right
`
`MS. LEBEIS Objection to the extent
`
`it mischaracterizes prior testimony.
`
`A
`
`I havent
`
`done the analysis and I
`
`suspect
`
`it
`
`depends
`
`on which formulation were
`
`talking about as to which would be the
`
`preservative of choice.
`
`Q
`
`That suspicion that you have is not
`
`based on any analysis that youve done is that
`
`right
`
`MS. LEBEIS Objection asked and
`
`answered.
`
`Argumentative.
`
`A
`
`Ive not done a detailed analysis
`
`but
`
`I have seen formulations that dont contain
`
`benzalkonium chloride as a preservative.
`
`Q
`
`A
`
`Which formulations are those
`
`I
`
`think we
`
`saw some earlier in one of
`
`the patents weve already looked at.
`
`Q
`
`Do you want
`
`to tell me which
`
`formulation that was
`
`A
`
`Q
`
`Document
`
`review.
`
`In the 929 patent.
`
`Document
`
`review.
`
`Apart
`
`from the formulation that
`
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`134
`
`STEPHEN G. DAVIES D.PHIL.
`
`youve seen in the 929 patent are you aware
`
`of any other
`
`formulations for ophthalmic use
`
`that dont contain benzalkonium chloride as the
`
`preservative
`
`MS. LEBEIS
`
`Dr. Davies you can take
`
`your
`
`time looking at
`
`the 929 patent
`
`in
`
`answering counsels question.
`
`Q
`
`Just
`
`to be clear
`
`though my question
`
`is apart
`
`from the formulations in the 929
`
`patent are you aware of any ophthalmic
`
`formulations that dont contain benzalkonium
`
`chloride as the preservative
`
`I dont
`
`think
`
`you need to look at
`
`the 929 patent
`
`to answer
`
`that question.
`
`But
`
`if
`
`you feel you do please
`
`feel
`
`free.
`
`A
`
`I believe Ive seen other
`
`formulations yes.
`
`Q
`
`Can you point
`
`to any of
`
`those
`
`formulations
`
`A
`
`Q
`
`Not sitting here at
`to Exhibit 4 the EP
`
`Lets go back
`
`this moment.
`
`984 patent.
`
`Okay.
`
`If
`
`you look at page 2 again
`
`at
`
`line 33 you see that
`
`the EP 984 patent
`
`The Little Reporting Company
`646 650-5055 1 www.littlereporting.com
`
`Page 134
`
`

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`135
`
`STEPHEN G. DAVIES D.PHIL.
`
`goes on to say that BAC has typically been
`
`considered to be incompatible with anionic
`
`drugs forming insoluble complexes which cause
`
`the solution to become cloudy or turbid.
`
`Do you see that
`
`it
`
`says that
`
`MS. LEBEIS Objection.
`
`Mischaracterizes the document.
`
`A
`
`Q
`
`Thats what
`
`it says.
`
`It goes on to say that such
`
`complexation between
`
`an anionic drug and BAC
`
`can
`
`cause a decrease in the pharmaceutical
`
`activity of
`
`the drug.
`
`Do you see that
`
`MS. LEBEIS Objection.
`
`Mischaracterizes the document.
`
`A
`
`Its the same as the previous
`
`cases.
`
`I dont see any evidence
`
`that thats true that
`
`there is a problem.
`
`Q
`
`You would agree though
`
`that EP 984
`
`asserts that thats a problem right
`
`MS. LEBEIS Objection to the form of
`
`the question asked and answered to the
`
`extent
`
`it mischaracterizes prior testimony.
`
`A
`
`It makes a broad statement without
`
`The Little Reporting Company
`646 650-5055 1 www.littlereporting.com
`
`Page 135
`
`

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`136
`
`STEPHEN G. DAVIES D.PHIL.
`
`any evidence.
`
`Q
`
`And that broad statement
`
`is that
`
`theres a problem of complexation between
`
`anionic drugs and BAC right
`
`MS. LEBEIS Objection to the extent
`
`it mischaracterizes prior testimony and
`
`mischaracterizes the document.
`
`A
`
`It doesnt give any evidence
`
`that
`
`such a complex would form.
`
`Q
`
`But
`
`the EP 984 nonetheless makes the
`
`broad statement
`
`that
`
`there is a problem of
`
`complexation between anionic drugs and BAC
`
`right
`
`MS. LEBEIS Objection.
`
`Asked and
`
`answered mischaracterizes the document
`
`and to the extent
`
`it mischaracterizes prior
`
`testimony.
`
`A
`
`Without any evidence
`
`a person of
`
`ordinary skill wouldnt be able to take
`
`anything from that.
`
`Q
`
`Lets look at paragraph --
`
`the
`
`paragraph on page 2
`
`just below the one we were
`
`looking at.
`
`A
`
`Okay.
`
`The Little Reporting Company
`646 650-5055
`www.littlereporting.com
`
`Page 136
`
`

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`24
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`25
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`137
`
`STEPHEN G. DAVIES D.PHIL.
`says In the past
`
`Do you see that
`
`it
`
`Q
`
`as in the case with other ophthalmic drugs that
`
`contain a carboxylic acid group
`
`anti-inflammatory solutions of NSAIDs
`
`for
`
`ocular use have proven to be incompatible with
`
`quaternary ammonium compounds
`
`such as BAC.
`
`MS. LEBEIS Objection.
`
`Mischaracterizes the document.
`
`Q
`
`A
`
`Do you see that
`
`it
`
`says that
`
`It
`
`says those words but
`
`theres no
`
`evidence
`
`to allow person of ordinary skill
`
`to
`
`understand if
`
`theyre correct or not.
`
`Q
`
`Okay.
`
`But
`
`those are the words that
`
`the patent uses right
`
`MS. LEBEIS Objection.
`
`Asked and
`
`answered.
`
`A
`
`The words are written down in the
`
`patent but without any evidence
`
`a person of
`
`ordinary skill cant
`
`take anything from them.
`
`Q
`
`And it goes on to explain that
`
`this
`
`incompatibility is due to the fact
`
`that
`
`the
`
`carboxylic acid group can form a complex with
`
`the quaternary ammonium compound rendering the
`
`preservative less available to serve its
`
`The Little Reporting Company
`646 650-5055 1 www.littlereporting.com
`
`Page 137
`
`

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`24
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`25
`
`138
`
`STEPHEN G. DAVIES D.PHIL.
`
`function and reducing the activity of
`
`the
`
`active ingredient right Thats what
`
`it says
`
`MS. LEBEIS Objection
`
`mischaracterizes the document.
`
`A
`
`Thats an assumption for which there
`
`is no evidence.
`
`Q
`
`So this EP 984 patent
`
`talks about
`
`the general problem of complexation between
`
`drugs ophthalmic drugs in the carboxylic acid
`
`group and benzalkonium chloride consistent with
`
`the way that
`that problem was discussed in
`Exhibits 2 and 3 the 876 and 929 patents
`
`right
`
`MS. LEBEIS Objection.
`
`Mischaracterizes the document.
`
`Asked and
`
`answered.
`
`A
`
`In none of
`
`the patents is there any
`
`evidence
`
`that
`
`this problem actually exists.
`
`Q
`
`You would agree though
`
`that
`
`the
`
`statement of
`
`this problem in EP 984 at
`
`the
`
`paragraph from line -- on page 2 lines 29
`
`looked at
`
`through 44 is consistent with the statement we
`in the 876 patent Exhibit 2 at
`column 1 lines 10 through 24 right
`
`The Little Reporting Company
`646 650-5055
`1 www.littlereporting.com
`
`Page 138
`
`

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`
`STEPHEN G. DAVIES D.PHIL.
`
`MS. LEBEIS Objection to the form of
`
`139
`
`the question and to the extent
`
`it
`
`mischaracterizes prior testimony.
`
`A
`
`They describe the same general
`
`purported problem for which there is no
`
`evidence being presented.
`
`So a person of
`
`ordinary skill wouldnt be concerned about
`
`it
`
`unless they faced it.
`
`Q
`
`And the discussion in EP 984 of
`
`this
`
`general problem of complexation between
`
`carboxylic-acid-containing compounds and BAC
`
`does not mention any differences
`
`between
`
`different NSAID compounds
`
`in terms of their
`
`chemical structure as being relevant
`
`to that
`
`problem right
`
`MS. LEBEIS Objection.
`
`Mischaracterizes the document.
`
`A
`
`Well
`
`it wouldnt
`
`though because
`
`its not what
`
`the rest of
`
`the patent
`
`is about.
`
`So they wouldnt need to discuss those things.
`
`Q
`
`Theres also no discussion in the EP
`
`984 of any differences between NSAID compounds
`
`in terms of
`
`their electron density right
`
`MS. LEBEIS
`
`Same objection.
`
`The Little Reporting Company
`646 650-5055
`www.littlereporting.com
`
`Page 139
`
`

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`140
`
`STEPHEN G. DAVIES D.PHIL.
`
`A
`
`It wouldnt discuss such matters
`
`because
`
`theyre irrelevant
`
`to what
`
`the rest of
`
`the patent
`
`is discussing.
`
`Q
`
`Theres also no discussion in EP 984
`
`of differences
`
`between NSAIDs
`
`in terms of
`
`whether
`
`theyre primary secondary or tertiary
`
`amines right
`
`MS. LEBEIS
`
`Same objection.
`
`A
`
`They wouldnt do because
`
`its not
`
`what
`
`the patent
`
`goes on to discuss.
`
`Q
`
`There is also no discussion in EP
`
`984 of
`
`the impact of
`
`the presence or absence
`
`of halogenation on NSAIDs
`
`as relevant
`
`to the
`
`issue of complexation right
`
`MS. LEBEIS
`
`Same objection and
`
`objection to the form of
`
`the question.
`
`A
`
`It wouldnt discuss that because its
`
`not
`
`relevant
`
`to the rest of
`
`the patent.
`
`Q
`
`A
`
`So theres no discussion right
`
`MS. LEBEIS
`
`Same objection.
`
`Nor would a person of ordinary skill
`
`expect
`
`there to be a discussion.
`
`Q
`
`So there is no discussion in the
`
`patent of presence or absence of halogenation
`
`The Little Reporting Company
`646 650-5055 1 www.littlereporting.com
`
`Page 140
`
`

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`141
`
`STEPHEN G. DAVIES D.PHIL.
`
`of different NSAIDs right
`
`MS. LEBEIS
`
`Same objection.
`
`A
`
`There is no discussion because
`
`its
`
`irrelevant
`
`to the rest of
`
`the patent.
`
`Q
`
`Theres also no discussion in the
`
`patent of
`
`the differences between NSAIDs
`
`in
`
`terms of their degree of
`
`lipophilicity with
`
`respect
`
`to this problem of complexation right
`
`MS. LEBEIS
`
`Same objection.
`
`A
`
`There is no discussion because
`
`it
`
`would be irrelevant
`
`to the rest of
`
`the patent.
`
`Q
`
`Theres also no discussion in the
`
`patent
`
`regarding the degree -- differences
`
`in
`
`the degree of hydrogen bonding as between
`
`different NSAIDs as it
`
`relates to the issue of
`
`complexation.
`
`MS. LEBEIS
`
`Same objection.
`
`A
`
`No because
`
`its irrelevant
`
`to the
`
`rest of
`
`the patent.
`
`Q
`
`And theres also no discussion about
`
`the degree of solvation of any of
`
`the NSAIDs
`
`in
`
`this patent
`
`in relation to the problem of
`
`complexation right
`
`MS. LEBEIS Objection.
`
`The Little Reporting Company
`646 650-5055
`1 www.littlereporting.com
`
`Page 141
`
`

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`24
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`25
`
`142
`
`STEPHEN G. DAVIES D.PHIL.
`
`Mischaracterizes the document.
`
`A
`
`I dont believe so because
`
`it would
`
`be well
`
`irrelevant
`
`to the rest of
`
`the patent.
`
`Q
`
`A
`
`Q
`
`Now lets look at page 4

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