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`IPR2015-01097, Paper No. 63
`IPR2015-01099, Paper No. 62
`IPR2015-01100, Paper No. 63
`IPR2015-01105, Paper No. 63
`June 30, 2016
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`RECORD OF ORAL HEARING
`UNITED STATES PATENT AND TRADEMARK OFFICE
`- - - - - -
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`LUPIN LTD., INC.,
`Petitioner,
`vs.
`SENJU PHARMACEUTICAL CO., LTD.,
`Patent Owner.
`- - - - - -
`Case IPR2015-01097 (Patent No. 8,754,131 B2)
`Case IPR2015-01099 (Patent No. 8,669,290 B2)
`Case IPR2015-01100 (Patent No. 8,927,606 B1)
`Case IPR2015-01105 (Patent No. 8,871,813 B2)
`Technology Center 1600
`
`
`Before: FRANCISCO C. PRATS, ERICA A. FRANKLIN,
`and GRACE KARAFFA OBERMANN, Administrative Patent Judges.
`
`The above-entitled matter came on for hearing on Thursday,
`June 9, 2016, at 10:00 a.m., Hearing Room D, taken at the U.S. Patent and
`Trademark Office, 600 Dulany Street, Alexandria, Virginia.
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`REPORTED BY: RAYMOND G. BRYNTESON, RMR,
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`CRR, RDR
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`571-272-7822
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`IPR2015-01097, Paper No. 63
`IPR2015-01099, Paper No. 62
`IPR2015-01100, Paper No. 63
`IPR2015-01105, Paper No. 63
`June 30, 2016
`
`RECORD OF ORAL HEARING
`UNITED STATES PATENT AND TRADEMARK OFFICE
`- - - - - -
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`- - - - - -
`LUPIN LTD., INC.,
`Petitioner,
`vs.
`SENJU PHARMACEUTICAL CO., LTD.,
`Patent Owner.
`- - - - - -
`Case IPR2015-01097 (Patent No. 8,754,131 B2)
`Case IPR2015-01099 (Patent No. 8,669,290 B2)
`Case IPR2015-01100 (Patent No. 8,927,606 B1)
`Case IPR2015-01105 (Patent No. 8,871,813 B2)
`Technology Center 1600
`
`
`Before: FRANCISCO C. PRATS, ERICA A. FRANKLIN,
`and GRACE KARAFFA OBERMANN, Administrative Patent Judges.
`
`The above-entitled matter came on for hearing on Thursday,
`June 9, 2016, at 10:00 a.m., Hearing Room D, taken at the U.S. Patent and
`Trademark Office, 600 Dulany Street, Alexandria, Virginia.
`
`REPORTED BY: RAYMOND G. BRYNTESON, RMR,
`
`CRR, RDR
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`APPEARANCES:
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`ON BEHALF OF THE PETITIONER:
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`ON BEHALF OF THE PATENT OWNER:
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`DEBORAH H. YELLIN, ESQ.
`TERESA STANEK REA, ESQ.
`SHANNON LENTZ, ESQ.
`Crowell & Moring LLP
`1001 Pennsylvania Avenue, N.W.
`Washington, D.C. 20004-2595
`202-624-2500
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`BRYAN C. DINER, ESQ.
`JUSTIN J. HASFORD, ESQ.
`CHIAKI FUJIWARA, ESQ.
`JOSHUA L. GOLDBERG, ESQ.
`Finnegan, Henderson, Farabow,
` Garrett & Dunner, LLP
`901 New York Avenue, N.W.
`Washington, D.C. 20001-4413
`202-408-400
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`JESSICA M. LEBEIS, ESQ.
`Finnegan, Henderson, Farabow,
` Garrett & Dunner, LLP
`3500 SunTrust Plaza
`303 Peachtree Street, NE
`Atlanta, Georgia 30308-3263
`404-653-6400
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`P R O C E E D I N G S
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`(10:00 a.m.)
`JUDGE PRATS: Please be seated. This is the
`final consolidated oral hearing for four IPR proceedings,
`IPR2015- 01097, 01099, 01100 and 01105. The parties are
`Petitioner, Lupin Limited as Petitioner, and Patent Owner is
`Senju.
`
`I guess we should start with appearances.
`Petitioner, please.
`MS. YELLIN: Thank you, Your Honor. My name
`is Deborah Yellin for Petitioner, Lupin. And with me today is
`Teresa Stanek Rea and Shannon Lentz.
`JUDGE PRATS: Thank you. Patent Owner?
`MR. DINER: Good morning, Your Honor. My
`name is Bryan Diner. We're representing the Patent Owner,
`Senju, et al. I'm joined by co- counsel Justin Hasford, Chiaki
`Fujiwara, Josh Goldberg, and Jessica Lebeis.
`JUDGE PRATS: Thanks very much. I only have a
`few introductory remarks. As we explained in our order and
`as the parties agreed, Petitioner, you will have 45 minutes for
`your case-in-chief, after which Patent Owner will have 60
`minutes, and after that Petitioner will have 15 minutes for
`rebuttal.
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`As procedure, to the extent that the parties have
`objections to the demonstratives, we will not be interrupting
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`the parties to lodge objections. I don't know, was there any --
`I saw the joint list of objections. Is there any kind of
`resolution as to certain slides that won't be presented or
`anything like that?
`MR. DINER: From the Patent Owners, Your
`Honor, no, we intend to submit and speak to the slides we had
`submitted to the Board.
`JUDGE PRATS: Okay. As I said, we're not going
`to be objecting to -- go ahead. I'm sorry. Petitioner?
`MS. YELLIN: I'm so sorry, Your Honor. I was
`going to say it's the same with Petitioners; we're going to be
`presenting all of our slides.
`JUDGE PRATS: Okay. That's fine. I will just
`say a reminder. The demonstratives are not evidence. So you
`don't need to present a motion to exclude or anything like
`that.
`
`In that regard, I will remind the parties that our
`decision will only incorporate subject matter that is of record,
`and we are capable of distinguishing between subject matter
`and evidence that is of record and subject matter that is not.
`So, that is, if a slide is presented that might not be of record,
`we're not going to deal with that issue today.
`The last thing, there will be one instance where
`the parties, it will be acceptable for the parties to interrupt
`the proceeding, and that is when confidential material is being
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`discussed by anyone, including members of the Board. At that
`point the owner of the confidential material should speak up,
`needs to speak up to preserve the confidentiality of the
`material.
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`And I think that's all the remarks I had. So with
`that said, Petitioner, you have 45 minutes.
`MS. YELLIN: Thank you, Your Honor. Would
`you be willing to let me speak for 40 minutes for my prima
`facie case and then have 20 minutes for rebuttal?
`JUDGE PRATS: Absolutely.
`MS. YELLIN: Thank you. That's what I would
`like to do then.
`JUDGE PRATS: Well, actually, Patent Owner, are
`you fine with that?
`MR. DINER: We're fine with that, Your Honor.
`MS. YELLIN: Thank you.
`JUDGE PRATS: Thank you. When you are ready,
`Ms. Yellin.
`MS. YELLIN: Thank you, Your Honor. Good
`morning, Your Honors. I'm Deborah Yellin for Petitioner,
`Lupin. I am here today to discuss why patents -- the '131
`patent, the '290 patent, the '606 patent and the '813 patent are
`invalid.
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`The comments I will make today apply equally to
`these four patents unless I otherwise specify because, as Your
`Honors have seen, these claims are very similar.
`With Your Honors' permission I would actually
`like to start with a very quick summary of our prima facie
`case and then I can hit each point in detail following that.
`Okay. The combination of Ogawa and Sallmann
`teach each and every element of the claims of the four patents
`at issue today. However, the prior art provides a rich
`background motivating one of skill in the art to
`combine Ogawa and Sallmann with a reasonable expectation
`of success at arriving at the claims at issue.
`Bromfenac was known to be an effective NSAID.
`In 1990 Ogawa disclosed an ophthalmic formulation of
`bromfenac with polysorbate 80.
`Within Ogawa a POSA would have chosen
`Example 6 because Example 6 has the best residual rate. And
`in 2000 a commercial formulation with the same ingredients
`as Ogawa Example 6 was marketed in Japan as Bronuck.
`It is known in the art that both polysorbate 80 and
`tyloxapol are nonionic surfactants. However, there is a strong
`motivation in the art to substitute tyloxapol in for polysorbate
`80.
`
`First, the formulation needs a preservative to
`prevent microbial growth, and this is definite when the
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`formulation is one that is going to be unsealed and then used
`over time in an open container.
`The art taught the common use of benzalkonium
`chloride, or BAC, and that BAC was so effective that, rather
`than trying to replace BAC if you have any issues with it, one
`of skill in the art should try and do whatever they can to make
`it work.
`
`It was well known in the art that NSAIDs form
`insoluble complexes in the presence of BAC due to the
`negative carboxylic acid moiety on the NSAID.
`Now, the NSAID/BAC complexes are definitely a
`problem from physical stability. They cause cloudiness of the
`formulation and turbidity and this is known and it's taught by
`the art.
`
`However, these NSAID/BAC complexes also cause
`problems for the API itself and for the preservative efficacy.
`This is because the complex just so happens here to be made
`up of an NSAID complexed to the BAC.
`So because the bromfenac is complexed with the
`BAC, it's in an insoluble, complexes out of solution. And the
`art teaches that when that NSAID complexes with the BAC it
`is not available to perform its active ingredient function.
`JUDGE PRATS: Counsel, we didn't go forward on
`the ground that involved complexation. The institution, the
`trial was instituted for substituting one equivalent, a
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`surfactant for another. So wherein the ground that we
`instituted on, we really didn't talk about the complexation, did
`we?
`
`MS. YELLIN: Well, Your Honor, the ground is
`Ogawa plus Sallmann. And Ogawa plus Sallmann teaches
`each and every element of the claimed invention. So Ogawa
`has Example 6 of the formulation with polysorbate 80, and
`Sallmann has tyloxapol. And it is our view that those are
`interchangeable and that both are known to be nonionic
`surfactants.
`However, the record, in our original petition we
`discussed the teaching of Fu. And Fu does teach that
`tyloxapol is better at effecting NSAID/BAC complexes than
`polysorbate 80. And that was in our original petition, Your
`Honor.
`
`JUDGE PRATS: If it was in the petition that was
`your -- so basically we went forward on only one of the two
`grounds. The Fu ground, as I remember, was the
`complexation, correct? And the Ogawa plus Sallmann, that is
`the substitution.
`So I'm just worried that -- my concern is that we're
`talking about a motivation that really wasn't part of the
`ground upon which trial was instituted, or are you saying this
`is just background art?
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`MS. YELLIN: Well, it is background art. So let
`me maybe summarize the position again then. So Ogawa and
`Sallmann teach each and every element of the claimed
`invention together. However, it is entirely appropriate to use
`background art to help show your motivation to combine and
`to help show your reasonable expectation of success.
`And in our view, for example, Fu, which discusses
`complexation, and there is other background art that we
`presented that also discusses complexation is, you know,
`certainly appropriate to provide the support.
`JUDGE OBERMANN: Do you argue that in your
`petition in the context of the ground based on Ogawa and
`Sallmann?
`MS. YELLIN: We did argue in our petition, Your
`Honor, and also in Dr. Lawrence's initial declaration.
`JUDGE OBERMANN: In the context of that
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`ground?
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`MS. YELLIN: In the context of that ground I'm
`not quite certain, Your Honors.
`JUDGE FRANKLIN: And is it necessary with
`respect to your position on obviousness that we understand
`that there is a complexation between the NSAID and BAC?
`MS. YELLIN: I think it certainly supports our
`case for obviousness, Your Honor. It is our position that both
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`of these are well known nonionic surfactants. However, the
`complexation is well taught by the art.
`May I continue?
`JUDGE PRATS: Please.
`MS. YELLIN: Okay. It is also our view that the
`solution to these complexes was taught by Fu. Fu teaches that
`ethoxylated octylphenol class of compounds does a better job
`of treating the BAC/NSAID complexes, not only at 60 degrees
`Celsius but also at 40 degrees and at room temperature.
`And when you look at polysorbate 80, for example,
`in the Fu reference, you see the polysorbate 80 failed to
`prevent the complexation at 40 degrees and at room
`temperature.
`Only two ethoxylated octylphenols were approved
`by the FDA as an active ingredient in 2003, and that's
`tyloxapol and octoxynol 40. Tyloxapol was used more often
`and, moreover, tyloxapol has a different molecular weight
`than octoxynol 40 such that one would believe that tyloxapol
`would be less toxic to the ocular membrane.
`So, Your Honor, it is our view that one of skill in
`the art would look to Ogawa. Here is a representative claim
`from the patents at issue containing -- requiring bromfenac
`and tyloxapol. And, of course, as Your Honors well know by
`now, Example 6 of Ogawa teaches bromfenac, but instead of
`tyloxapol, it has polysorbate 80.
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`And as you also know, there are other claims at
`issue here that actually list specific ingredients, and those
`ingredients are taught by Ogawa Example 6.
`Sallmann has a formulation that contains
`tyloxapol, along with diclofenac, which is an NSAID that has
`that carboxylic acid moiety on it, along with BAC. So
`Sallmann is a teaching that it is possible to formulate those
`together.
`
`I would like to make a quick comment about the
`teaching of Sallmann. Sallmann uses the word "solubilizer" to
`describe tyloxapol.
`However, as our expert, Dr. Lawrence, has
`consistently testified throughout the proceeding, just because
`Sallmann uses the word solubilizer doesn't mean that it can't
`also be acting as a surfactant or that it may not be stabilizing
`the formulation.
`So I just want to be clear that even though
`Sallmann uses the word solubilizer, it doesn't mutually
`exclude these other functions.
`JUDGE OBERMANN: Doesn't that implicate your
`primary argument that these were substitutions, you know,
`alternative substitutes to perform the same function?
`MS. YELLIN: I'm not sure I understand your
`question, Your Honor.
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`JUDGE OBERMANN: My understanding is your
`primary argument is that a person of ordinary skill in the art
`would have recognized polysorbate 80 and tyloxapol as
`interchangeable alternatives in an NSAID- containing
`composition.
`Now, what I just heard you to say is that perhaps
`the tyloxapol in Sallmann solubilizes but that it would have
`been used in Ogawa for some different function. Is that
`correct?
`
`MS. YELLIN: Sallmann is choosing to describe it
`as a solubilizer, and I don't necessarily believe, nor did Dr.
`Lawrence, that that means Sallmann is limiting it just to a
`solubilizing function.
`But I would also like to point out that the
`background art, such as Fu, is teaching that tyloxapol can
`have this function that affects an NSAID/BAC complexation.
`And it is our view that that complexation can affect physical
`stability in the active ingredient as well.
`Did I answer your question, Your Honor?
`JUDGE OBERMANN: Yes. I am still concerned
`because I am not seeing any reference to Fu in your ground,
`the argument that is really to this ground. I see argument in
`the context of -- I don't know to pronounce it -- Yasueda.
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`JUDGE PRATS: I think I can direct us to where in
`the ground upon which trial was instituted. I believe it is
`page 38 of the petition.
`It doesn't say it's Fu but there is a sentence that
`reads at follows: In fact substituting tyloxapol for
`polysorbate 80 in ophthalmic formulations have been shown to
`improve the stability of acidic group containing drugs, citing
`two exhibits, and one of them is Exhibit 1014 which is Fu.
`MS. YELLIN: Yes, Your Honor.
`JUDGE PRATS: I will say that I'm not sure that
`Fu supports a statement that you are substituting tyloxapol for
`polysorbate 80 because it seems like, as you said earlier, Fu is
`just talking about the general category of surfactants.
`MS. YELLIN: I actually disagree with that, Your
`Honor. And also, before I address that, I would also like to
`make the point that we have kind of a rich background section
`both in our petition and Dr. Lawrence's declaration that
`supports all of the grounds that we tried to put forth when we
`filed our original petition, for example, at page 8, and that
`discusses these issues as well.
`JUDGE PRATS: But I thought there was a
`concession that Fu doesn't describe using tyloxapol, and that's
`why you needed, in the first ground, that's why you needed the
`other reference, Sallmann?
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`MS. YELLIN: Sallmann discloses tyloxapol, yes,
`that's correct. Fu discloses that a class of ethoxylated
`octylphenols can address these NSAID/BAC complexes.
`That's what Fu teaches.
`And at the time in 2003 there were only two
`ethoxylated octylphenols that were approved by the FDA.
`And obviously you would want to use an excipient that's
`approved by the FDA to avoid further research and expense. I
`mean, that's a clear motivation.
`And those two, in the inactive ingredient guide,
`were tyloxapol and octoxynol 40. So it is really only a class
`of two that one of skill in the art is choosing based on
`reviewing Fu.
`JUDGE PRATS: So let's just back this up a little
`bit to my original question. So we are saying, based on that
`statement on 38 of the petition, that that is how Fu is properly
`understood to at least be background art as far as the ground
`upon which trial is instituted. Is that correct?
`MS. YELLIN: Yes, Your Honor. The background
`art provides motivation and expectation of success.
`JUDGE PRATS: Thank you.
`MS. YELLIN: Thank you. So why choose Ogawa
`Example 6 from the other examples in Ogawa? Well, first of
`all, and importantly, Ogawa Example 6 has the best residual
`rate of all of the examples, 100.9.
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`Moreover, of the examples that weren't affected by
`these red insoluble matters that Ogawa talks about, of those
`three, Examples 6, 7 and 8, Ogawa has the best residual rate.
`And I would like to take a quick moment to
`discuss the red insoluble matters of Ogawa. Ogawa doesn't
`actually explain what they are or offer any reasoning why
`sodium sulfite or PVP addresses these red insoluble matters
`that they are talking about.
`Dr. Lawrence has stated that she doesn't believe
`that there is a BAC/NSAID complexation issue. Patent Owner
`argues that they are oxidative degradation, and they haven't
`actually provided any evidence of this. However, it is our
`view that even though Example 6 doesn't appear to be subject
`to these red insoluble complexes, we still believe that a POSA
`would be concerned with the appearance because Ogawa here
`talks about appearance.
`Moreover, if Patent Owner is correct and the red
`insoluble matters actually are oxidative degradation, even
`though we don't agree that they have shown that, one of skill
`in the art would still be concerned with NSAID/BAC
`complexation.
`JUDGE PRATS: Does it matter what they are,
`because we know the problem that was solved by adding the
`sulfite and the PVP, right?
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`MS. YELLIN: Actually, Your Honor, we agree.
`We don't think it really matters what they are. Ogawa
`Example 6, which we believe is the best example in Ogawa,
`and also the closest prior art, doesn't suffer from those issues.
`JUDGE PRATS: Thank you.
`MS. YELLIN: Another reason to choose Ogawa
`Example 6 is that the ingredients that were used in Ogawa
`Example 6 also appear in a commercialized product in Japan
`called Bronuck. So why not use Example 7 and 8 of Ogawa?
`Well, first of all, as we've already said, Example 6
`has a better residual rate. Example 7 uses parabens. Dr.
`Lawrence has stated that parabens are undesirable as a
`preservative in the ophthalmic formulations because they are
`known not to be stable and actually can degrade at pH values
`around 8, which is a common pH for ophthalmic formulations.
`Moreover, they are not as effective preservatives as BAC.
`Example 8 doesn't have sodium edetate. And Dr.
`Lawrence stated that sodium edetate is very important in
`eyedrops and it actually acts as a chelating agent.
`So, in sum, one of skill in the art would have
`chosen Ogawa Example 6.
`Now, Ogawa never actually tells you what
`polysorbate 80 is doing in the formulation. However, Dr.
`Lawrence testified that polysorbate 80 is present to stabilize
`the formulation against the BAC/NSAID complexes. And
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`here, again, in order to provide some context to Ogawa, you
`can also look to Fu.
`Fu teaches that polysorbate 80 is able to affect
`NSAID/BAC complexation but at 60 degrees, and 60 degrees
`is the parameter that Ogawa has used for its testing.
`It is also our view that the amount of polysorbate
`80 that's taught in Ogawa is not consistent with the use of a
`wetting agent. So, therefore, we don't believe that
`polysorbate 80 is present as a wetting agent.
`And in sum, Dr. Lawrence looking at this
`formulation determined that she didn't think polysorbate 80
`could be serving any other function except addressing these
`NSAID/BAC complexes.
`It was well known in the art that BAC is the best
`preservative. And, in fact, here is Remington, which is well
`known to be a very important book in this art, that tells you
`that benzalkonium chloride is such a great preservative that,
`given the alternative, it is preferable to modify your
`formulation to address any incompatibility you see with BAC
`rather than trying to find another but less effective
`preservative.
`And this NSAID/BAC complexation problem was
`very well known. Here, for example, is a quote from Desai
`discussing it, and then also saying that the preservative that is
`part of this complex loses its ability to function as complexes
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`are formed with the charged drug compound, and the art is
`also teaching you that these complexes are caused by the
`negative moiety on the NSAID.
`That teaching also, for example, comes from
`Kibbe. And then down at the bottom we have other references
`that teach this as well.
`And, in fact, the patents at issue, the four patents
`we have here today, describe this benzalkonium chloride,
`these complexes as being an issue. It says right here:
`Benzalkonium chloride and other quaternary ammonium
`compounds are considered to be incompatible with ophthalmic
`compositions of drugs with acidic groups, such as NSAIDs.
`And yet, despite that, they have sought and they have made a
`formulation that has these two ingredients that could
`potentially complex. So in our view this was in the mind of
`the Patentee.
`JUDGE PRATS: So it is your position that even
`though Ogawa does not describe this as being a problem, I
`mean, it has all of these ingredients in there, and effectively
`solved it, I mean, we are not seeing any kind of issue, you
`would still solve the problem or make sure it didn't happen by
`switching?
`MS. YELLIN: Well, that's correct, and you would
`want to make a better formulation.
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`JUDGE OBERMANN: My problem is that Ogawa
`very clearly states that this was a problem with the red
`insoluble particles, right, and they address it in a different
`way by adding the sulfite and the PVP.
`I see no indication in Ogawa or Sallmann that
`anyone would have understood that polysorbate 80 was
`functioning in that Example 6 formulation to stabilize the
`product. Ogawa is all about stabilizing with two different
`entities.
`
`MS. YELLIN: Well, that's right, Your Honor.
`However, one looks to the background art for this and you
`would see a teaching in Fu. So Ogawa is teaching you a
`parameter, a single parameter, 60 degrees Celsius at four
`weeks. And at 60 degrees Celsius at four weeks, in a
`formulation that contains polysorbate 80, with the NSAID,
`you don't see any issue.
`But when you look to Fu, which was part of the
`background art that one of skill in the art would have been
`aware of, you see that while polysorbate 80 appears to be not
`causing any issues at 60 degrees, which is the parameter used
`by Ogawa, you actually start to see a problem when you lower
`the temperature --
`JUDGE OBERMANN: You don't see a problem
`when you read Ogawa, and that's the reference we're looking
`at. There is no problem in Ogawa's Example 6. They are
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`attaining their goals and they are attaining them with two
`separate moieties that have nothing to do with the polysorbate
`80, unless you can persuade us otherwise.
`MS. YELLIN: I think there is different issues
`with stability going on in Ogawa. So Ogawa talks about these
`red insoluble matters, and we don't know what they are.
`JUDGE OBERMANN: We know they are not in
`Example 6.
`MS. YELLIN: That's correct, and they solve that
`problem by using PVP and sulfite. But one of skill in the
`art would still do -- and Ogawa is only teaching the success
`with their formulation at this parameter of 60 degrees.
`So let's say one of skill in the art is reading Ogawa
`and they're saying, hey, this Example 6 looks very good, I
`think I would like to work with it, this seems to be a
`successful formulation, they are going to see that it is only at
`60 degrees so they are going to wonder what is going to
`happen when, for example, I lower the temperature.
`JUDGE OBERMANN: Let me ask you this: Are
`you abandoning your argument that someone of ordinary skill
`in the art would have simply substituted tyloxapol for
`polysorbate 80 without any rationale under this theory that
`they were completely interchangeable alternatives, or are you
`saying that that person would have recognized the superiority
`of tyloxapol and replaced it on that basis?
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`MS. YELLIN: It is your second, what you said,
`the second point was correct, Your Honor. We are not
`abandoning our position that they are interchangeable in that
`they are both nonionic surfactants. They are both known to
`act as nonionic surfactants.
`And, you are right, Ogawa does show that
`polysorbate 80, at least at 60 degrees, is providing a
`formulation that doesn't appear to have these issues.
`However, it is also our view that the fact that
`these BAC/NSAID complexes are very well known and that
`they can cause a problem because you want as much active
`ingredient available in your formulation, you want as much
`preservative as possible in your formulation, and you
`certainly want to avoid physical instability, that you are going
`to want to improve the amount, for example, of active
`ingredient you have. And so based on the background art of
`Fu, that would motivate you further to use tyloxapol.
`JUDGE OBERMANN: Okay. I hear you arguing a
`lot about the second point. And I would like you to please
`clearly flesh out your first point.
`I would like to know what is the rationale based on
`that first argument which formed the primary front part of
`your ground that an ordinary artisan would have viewed these
`two nonionic surfactants as interchangeable alternatives and
`that the law of obviousness would apply that says we don't
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`even need to find a reason to switch if they were
`interchangeable for the same function. And I want to make
`sure, if you are not abandoning that argument, that I
`understand what the basis of that is.
`MS. YELLIN: Okay, Your Honor. Okay. I will
`kind of flesh it out. So Ogawa Example 6 teaches your
`formulation with polysorbate 80. And it is our view, at least
`one of our arguments, that tyloxapol and polysorbate 80 here
`are interchangeable.
`Why would one of skill in the art go to their shelf
`and then say, hey, I'm going to use tyloxapol instead of
`polysorbate 80, and I believe that's what you are asking. So
`tyloxapol is also known as a successful surfactant. Sallmann
`teaches it, and Sallmann motivates one to choose it by saying
`it is a preferred solubilizer.
`And, as we have said, you know, Dr. Lawrence
`believes that it is not just perhaps using the solubilizing
`function but it can also serve other functions in the
`formulation as well.
`JUDGE OBERMANN: Do we need to find that the
`solubilizing function in Ogawa's formulation 6 was the same
`as the function of the tyloxapol in Sallmann's Example 2?
`MS. YELLIN: Well, as we've already said, Ogawa
`doesn't explicitly tell you what the polysorbate 80 is doing in
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`the formulation. However, I agree that would strengthen the
`case, Your Honor.
`JUDGE OBERMANN: Do you have any argument
`that that was the case?
`MS. YELLIN: Dr. Lawrence argues in her
`declaration, and she is a formulator of great skill, that --
`JUDGE OBERMANN: Does she say it would have
`been used as a solubilizer in Ogawa's formulation?
`MS. YELLIN: She is teaching that when you look
`at Sallmann, it's not exclusively limited to being a solubilizer,
`Your Honor, that one of skill in the art could actually look at
`Sallmann and see that that doesn't mean that it can't act as a
`surfactant or that it is necessarily acting in the formulation as
`a solubilizer. One of skill in the art comes to the table with
`what they know.
`JUDGE OBERMANN: What I'm taking away is
`that you have no argument that the tyloxapol would act as a
`solubilizer in Ogawa's formulation. Is that correct?
`MS. YELLIN: I think tyloxapol is known as a
`solubilizer, Your Honor.
`JUDGE OBERMANN: Do you have any evidence
`that it would act as a solubilizer in Ogawa's Example 6
`formulation?
`MS. YELLIN: I think one of skill in the art -- let
`me put this another way -- I think one of skill in the art, based
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`on what Dr. Lawrence has taught, that she believes that
`tyloxapol would be serving the same function as what the
`polysorbate 80 is doing.
`JUDGE OBERMANN: It would be serving a
`function of what?
`MS. YELLIN: Providing stability to the
`formulation and the idea of physical stability, for example.
`One moment, Your Honor.
`She does say in her declaration that it is there in
`Ogawa to prevent insoluble complexes. When she read Ogawa
`she looked at all of the ingredients in Ogawa, just as one of
`skill in the art would do, and she looked at the other
`ingredients and she looked at the polysorbate 80 and she
`determined it was there to prevent insoluble complexation.
`That's what she says in her declaration, Your Honor, based on
`her skill as a formulator.
`Now, we've talked a lot about these NSAID/BAC
`complexes, and those are c
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