trials@uspto.gov
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`571-272-7822
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`IPR2015-01773, Paper No. 35
`IPR2015-01775, Paper No. 36
`January 23, 2017
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`
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`RECORD OF ORAL HEARING
`UNITED STATES PATENT AND TRADEMARK OFFICE
`- - - - - -
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`- - - - - -
`LUPIN LTD. and LUPIN PHARMACEUTICALS INC.,
`Petitioner,
`v.
`POZEN INC.,
`Patent Owner.
`- - - - - -
`Case IPR2015-01773 (Patent 8,858,996 B2)
`Case IPR2015-01775 (Patent 8,865,190 B2)
`Technology Center 1600
`Oral Hearing Held: Tuesday, November 29, 2016
`Before: TONI R. SCHEINER, LORA M. GREEN, and
`JACQUELINE WRIGHT BONILLA, Administrative Patent Judges.
`
`The above-entitled matter came on for hearing on Tuesday,
`November 29, 2016, at 9:18 a.m., Hearing Room B, taken at the U.S. Patent
`and Trademark Office, 600 Dulany Street, Alexandria, Virginia.
`
`REPORTED BY: RAYMOND G. BRYNTESON, RMR,
`
`CRR, RDR
`
`
`
`571-272-7822
`
`IPR2015-01773, Paper No. 35
`IPR2015-01775, Paper No. 36
`January 23, 2017
`
`
`
`
`RECORD OF ORAL HEARING
`UNITED STATES PATENT AND TRADEMARK OFFICE
`- - - - - -
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`- - - - - -
`LUPIN LTD. and LUPIN PHARMACEUTICALS INC.,
`Petitioner,
`v.
`POZEN INC.,
`Patent Owner.
`- - - - - -
`Case IPR2015-01773 (Patent 8,858,996 B2)
`Case IPR2015-01775 (Patent 8,865,190 B2)
`Technology Center 1600
`Oral Hearing Held: Tuesday, November 29, 2016
`Before: TONI R. SCHEINER, LORA M. GREEN, and
`JACQUELINE WRIGHT BONILLA, Administrative Patent Judges.
`
`The above-entitled matter came on for hearing on Tuesday,
`November 29, 2016, at 9:18 a.m., Hearing Room B, taken at the U.S. Patent
`and Trademark Office, 600 Dulany Street, Alexandria, Virginia.
`
`REPORTED BY: RAYMOND G. BRYNTESON, RMR,
`
`CRR, RDR
`
`
`
`APPEARANCES:
`
`ON BEHALF OF THE PETITIONER:
`
`
`SAILESH K. PATEL, ESQ.
`
`
`HELEN H. JI, ESQ.
`
`
`Schiff Hardin
`
`
`233 South Wacker Drive, Suite 6600
`
`
`Chicago, Illinois 60606
`
`
`312-258-5500
`
`
`
`
`
`
`
`
`ON BEHALF OF THE PATENT OWNER:
`
`
`JAMES B. MONROE, ESQ.
`
`
`DANIELLE C. PFIFFERLING, ESQ.
`
`
`Finnegan, Henderson, Farabow,
`
`
` Garrett & Dunner, LLP
`
`
`901 New York Avenue, N.W.
`
`
`Washington, D.C. 20001-4413
`
`
`202-408-4000
`
`STEPHEN J. SMITH, ESQ.
`JOHN K. HSU, PH.D.
`Schiff Hardin
`901 K Street, N.W., Suite 700
`Washington, D.C. 20001
`202-778-6400
`
`
`
`
`
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`Case IPR2015-01775 (Patent 8,865,190 B2)
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`P R O C E E D I N G S
`
` (9:18 a.m.)
`JUDGE BONILLA: Good morning. This is a trial
`hearing for two inter partes review cases, IPR2015- 01773 and
`IPR2015- 01775 between Petitioner Lupin Limited and Lupin
`Pharmaceuticals Inc. and Patent Owner Pozen Inc., the owner
`of U.S. patents at issue in the two respective cases, that is
`Patent Number 8,858,996 at issue in the 1773 case and also
`8,865,190, which is at issue in the 1775 case.
`We will just discuss briefly a few administrative
`matters before we begin. Just as a reminder to the people
`presenting, if you are presenting any demonstratives, if you
`could actually identify the slide by number as you are going
`through, that makes it easier for people to follow the transcript
`later.
`
`And as you know, per our order, each side has 60
`minutes to present their argument. Because Petitioner has the
`burden to show unpatentability of the claims, they will go
`first, followed by Patent Owner who have the full 60 minutes.
`Petitioner, you may reserve rebuttal time so you
`can take some now and some later if you like. But during your
`rebuttal time you can only respond to arguments that Patent
`Owner makes in their portion of the oral hearing.
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`At this time I would like counsel to introduce
`themselves and who you have with you, beginning with
`Petitioner.
`MR. PATEL: Good morning, Your Honor. My
`name is Sailesh Patel. Along with me is my colleague John
`Hsu and Stephen Smith and Helen Ji from the Schiff Hardin
`law firm.
`
`MR. MONROE: Good morning, Your Honor.
`James Monroe from Finnegan on behalf of Pozen, and with me
`today is Danielle Pfifferling.
`JUDGE BONILLA: And, Petitioner, would you
`like to reserve any time?
`MR. PATEL: Yes, Your Honor. We would like to
`reserve 15 minutes for rebuttal.
`JUDGE BONILLA: Okay. You may begin.
`MR. PATEL: Good morning, Your Honors. And
`as I said, my name is Sailesh Patel and we are delighted to be
`here today on the IPR petitions for the '996 and '190 patents.
`Here on slide 2 is a brief outline of what we would
`like to discuss today. The Panel has granted a petition on
`some of the claims in both patents and so we have a section on
`the fact that the prior art discloses each element of the
`asserted claims, but unless the Panel has any specific
`questions about where certain elements are located in the prior
`art I will probably skip over to the crux of the issues here,
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`which is whether the challenged claims would have been
`obvious.
`
`And looking at the prior art that was used, the
`'225, the WO '185 and Chandramouli, we believe it shows all
`of the elements in the claim, provides the motivation to
`replace two ingredients, misoprostol with the esomeprazole,
`that's in the patent in suit, and replacing naproxen with the
`NSAIDS that are disclosed in the '225 patent.
`And we believe that a POSA would have had a
`reasonable expectation of success in making such a
`formulation. And to the extent Patent Owner raises any
`secondary considerations, they were not raised in the response
`to the petition, but to the extent that any secondary
`considerations are raised, I will address those in rebuttal.
`So looking at slide 4, this is the '996 patent
`entitled "Pharmaceutical Compositions for the Coordinated
`Delivery of NSAIDS." The priority date here is June 1, 2001,
`and the claims are directed to the tablet pharmaceutical
`composition, comprising of naproxen in a certain amount,
`esomeprazole in a certain amount, and it has a feature wherein
`at least a portion of said esomeprazole is released regardless
`of the pH, and release of at least a portion of naproxen is
`inhibited until the pH of the medium goes to 3.5 or higher.
`The '190 patent, they are part of the same family,
`that also has a priority date of June 1, 2001. And this claim is
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`just slightly different from the claims in the '996 patent. It is
`directed to a process for preparing a pharmaceutical
`composition. It provides a little bit more structure. It talks
`about providing a first layer comprising naproxen and
`applying a second layer to said first layer that comprises said
`esomeprazole.
`It has the same language wherein at least a portion
`of the esomeprazole is released regardless of the pH and
`release of at least a portion of said naproxen is inhibited
`unless the pH of the medium is 3.5 or higher.
`And the way they do this is by using an enteric
`coating over the naproxen core, which I will show in some of
`the later slides.
`So these are the instituted grounds in slide 6. The
`prior art that the Panel instituted the petition on is ground 4,
`which is that the claims 1, 3 and 11 of the '996 and 1, 2 and 4
`to 8 of the '190 would have been obvious over the '225 patent
`in view of Chandramouli and WO '185.
`Just generally, the '225 patent, it is directed to the
`same problem that the patents in suit are directed to, in the
`same field, in the sense that they are -- it is directed to
`preventing or providing prophylactic treatment to patients who
`are on chronic NSAID use.
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`Patients that are chronically taking NSAIDS are
`susceptible to getting gastric injury. The '225 patent is
`directed to this field, and it --
`JUDGE BONILLA: Is there any evidence that the
`prostaglandin in the '225 patent has the same issue that you
`see with the PPIs being acid labile in the stomach?
`MR. PATEL: That's a good question, Your Honor.
`The '225 patent does not mention whether or not misoprostol
`as a prostaglandin is acid labile per se, but it does disclose
`that the misoprostol is an unstable compound so there are
`stability issues with misoprostol but it is silent on whether or
`not it is acid labile.
`JUDGE BONILLA: Is it also silent as far as
`keeping it stable?
`MR. PATEL: I'm sorry?
`JUDGE BONILLA: Is it also silent in terms of
`keeping it stable?
`MR. PATEL: The patent does not disclose how
`one goes about keeping misoprostol stable.
`We have Chandramouli, which is also in the same
`field, it's directed to the prevention and management of
`NSAID- induced gastropathy. This is a prior art article that
`talks about concomitant therapy with PPIs and NSAIDS. It
`includes the disclosure of omeprazole and discusses the use of
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`NSAIDS to treat -- the use of PPIs along with NSAIDS to treat
`gastric acid injury.
`The WO '185 discloses specifically omeprazole
`formulations that are in suspension or also in solid preparation
`that provide a different way of administering omeprazole that
`does not include an enteric coat but providing an alkaline
`compound such as sodium bicarbonate to administer the drug,
`also for prophylactic effect, and by prophylactic is to prevent
`gastric ulcers as opposed to treating ulcers and gastric injury
`that has already occurred.
`So we are going to skip through these slides which
`basically just point out where in each prior art reference the
`elements are disclosed and get to the heart of the issue here.
`So if we turn to slide 36, I believe -- 34, and then
`looking at 35, as I discussed, the '225 patent in its background
`talks about the problem that it is dealing with. And it is the
`same field as the patent in suit, providing a prophylactic
`treatment for patients that are on chronic NSAID use to avoid
`gastric injury.
`JUDGE BONILLA: Now, in this particular
`reference they talk about two specific NSAIDS. Is there
`anything in that reference itself that suggests that you could
`use a different NSAID?
`MR. PATEL: Your Honor, in this reference it
`provides two NSAIDS as an example, diclofenac and
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`piroxicam. And it describes -- it just provides those as
`exemplary. It does not prohibit the use of other NSAIDS.
`And when you look at it --
`JUDGE BONILLA: But it doesn't mention any
`others, is that correct?
`MR. PATEL: It doesn't explicitly mention others
`but it mentions NSAIDS. And if one looks at Chandramouli,
`Chandramouli describes the class of NSAIDS including
`diclofenac and piroxicam and describes that they all have
`similar therapeutic effect.
`JUDGE BONILLA: So one of the issues that
`Patent Owner raises in the response is that in the petition
`itself there isn't any argument as to why one would substitute
`the NSAIDS there for the NSAID that is in the other reference,
`the one that is at issue here, the naproxen.
`Can you address that? Where in your petition do
`you actually talk about why one would have had reason to
`substitute it?
`MR. PATEL: Sure, Your Honor. The reason to
`substitute is particularly in the Chandramouli reference, where
`if you look at table 2 -- let me see if I can find that -- table 2
`of the Chandramouli reference lists all of the various NSAIDS
`that were known --
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`JUDGE BONILLA: And I see a discussion of that
`in the reply. I'm just wondering if you had a similar type of
`discussion in the petition itself?
`MR. PATEL: Your Honor, I believe we had a
`discussion that naproxen, a person of ordinary skill in the art
`would have known to -- would have been aware of naproxen
`based on the prior art, its availability since 1976, to treat
`chronic arthritis and there would have been a motivation to
`replace naproxen -- replace diclofenac or piroxicam with
`naproxen, especially in view of the teachings of
`Chandramouli.
`JUDGE BONILLA: If you can identify the cite in
`the petition that would be great, and if you need a moment,
`that's fine, I'll grant it.
`MR. PATEL: We may need a moment. If I could
`go on to other parts of the argument.
`JUDGE BONILLA: Sure.
`MR. PATEL: So, Your Honors, the '225, it taught
`the same pill structure, with the NSAID core, the enteric
`coating and a misoprostol outer mantle. The only difference
`here is the, as Your Honor recognized, the use of naproxen in
`the core and the use of esomeprazole in the mantle.
`JUDGE GREEN: Now, does the '225 patent
`suggest anything else besides the prostaglandins as a
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`protection or is it just basically drawn towards the
`prostaglandins for that use?
`MR. PATEL: The '225 discloses the prostaglandin
`misoprostol, but I think when you look at Chandramouli,
`Chandramouli and the '225 need to be viewed together in the
`same field. And Chandramouli specifically talks about PPIs
`and prostaglandins and specifically mentions the head- to- head
`study between PPIs, particularly omeprazole, and misoprostol,
`the OMNIUM study, and found that the omeprazole worked
`just as good, if not better, than the misoprostol. But the '225
`itself discusses the acid inhibitor prostaglandins.
`Your Honor, I would like to talk about why a
`person would be motivated to replace misoprostol with
`esomeprazole, and I discussed a portion of that, but one thing
`that I mentioned at the outset is the '225 patent discloses that
`misoprostol is generally unstable but, more than that, there
`was disclosure that it had bad side effects such as diarrhea and
`abdominal pain, and also it induced abortions, so it was
`contraindicated for a large number of patients.
`And Chandramouli, as I mentioned, discussed the
`OMNIUM study, the head- to- head comparison, and disclosed
`that omeprazole worked better. So a person of ordinary skill
`in the art would have been looking at both of these references,
`which are directed to solving the same problem, and would
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`have been motivated to use omeprazole in place of
`misoprostol.
`JUDGE GREEN: Now, how is the PPI
`administered in Chandramouli? What is the dosage form?
`MR. PATEL: In Chandramouli it disclosed the
`Arthrotec dosage form, which is the same dosage form that is
`disclosed in the '225. And it also disclosed that PPIs and
`NSAIDS could be administered concomitantly, together. And
`it also referenced the, importantly, the Arthrotec dosage form.
`So a person of ordinary skill in the art looking at
`both of those references, they would have both NSAIDS -- the
`two references are addressing the same problem. Both the
`NSAIDS are talking about concomitant administration of an
`NSAID and acid inhibitor, and they are directed to the same --
`they talk about the same tripartite structure, the Arthrotec
`formulation.
`And here we don't think that there is any real issue
`here. The Board also found that it was well known that
`omeprazole exists in two enantiomers. One is the S
`enantiomer and the R enantiomer.
`And Dr. Banakar, our expert, also testified that it
`would have been well known to a person of skill in the art that
`omeprazole is comprised of these two enantiomers and that, in
`fact, the esomeprazole is known at the time to have certain
`better individual variability amongst patients. And so we
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`don't think this is an issue but, in case it comes up, that was
`well known in the art.
`Now, just to summarize, looking at slide 43, there
`were -- why the motivation to replace misoprostol with
`esomeprazole, the inherent disadvantages that were disclosed
`associated with misoprostol, the side effects, and the fact that
`the OMNIUM study disclosed that omeprazole had better
`results, and even WO '185 talked about it as being a logical
`choice for treating gastropathy.
`Now, there is a question that the Board raised in
`terms of why one would want to use immediate release
`omeprazole as opposed to enterically coating it. And the WO
`'185 patent talked about some of the advantages, particularly
`in this context of where you want to provide prophylactic
`effect, that there is an advantage to immediately releasing the
`acid inhibitor so that it increases the pH of the stomach earlier
`than if you were to enterically coat it, which would take
`several hours.
`And the WO '185 patent actually provided a
`method for doing that, and that is by using sodium bicarbonate
`or an alkaline compound.
`Here is portions of the WO '185 patent in slide 47
`that talk about some of the benefits of immediate delivery
`compared to the prior enteric-coated form. And it even
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`described it as an improvement over the prior art formulation
`requiring enteric coating.
`And the other issue that I would like to address is
`the issue of whether or not a sodium bicarbonate powder
`coating would be compatible with an enteric coating. And
`here we believe Patent Owner has essentially raised a
`red-herring with respect to what sodium bicarbonate would do
`to an enteric coating because this is in a solid dosage form,
`first.
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`JUDGE BONILLA: But the issue really isn't that.
`I mean, even if we buy your argument that it wouldn't impact
`the thing when it is solid, the minute it goes into the stomach
`it dissolves and becomes a bicarbonate solution.
`That's the concern that we had, is that it would
`create a bicarbonate solution that was there therein and, as
`discussed in the WO '185 itself, would, in fact, then start to
`dissolve the enteric coating.
`So the real issue for us is what evidence do we
`have that it wouldn't, in fact, dissolve the entire enteric
`coating before it leaves the stomach?
`MR. PATEL: A good question, and I can focus
`directly on that. So in the WO '185 there is an example
`wherein enterically-coated granules are put into a bicarbonate,
`sodium bicarbonate containing solution, agitated for 30
`minutes to dissolve the enteric coating.
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`First we have to look at the pill structure that we
`are using here, which is very different from that type of
`structure, where the sodium bicarbonate and the esomeprazole
`are on the outer coating, the outer shell of the pellet.
`So as it goes into the stomach, first it would be --
`the sodium -- and it would be also, let me mention, in a very
`acidic environment as opposed to the situation in the WO '185
`patent where the pellets are being dumped into an alkaline
`solvent, alkaline medium with sodium bicarbonate.
`Here you are going into an extremely acidic
`environment, a pH of 2 in the stomach. The sodium
`bicarbonate would be stabilizing the esomeprazole and it
`would diffuse out first, and the enteric coating would remain
`intact, and while all of this is happening the pill is still going
`down the digestive tract.
`JUDGE BONILLA: I appreciate the argument that
`you are making now. I'm trying to find where that is in either
`your petition or your reply where you talk about looking for
`evidence of what you are talking about now, that it would, in
`effect, disseminated or whatever, it wouldn't, in fact, have
`killed, if you will, the entire enteric coating?
`MR. PATEL: I think we will try to get cites for
`that, I think it was definitely in the rehearing request, but it
`may also be in the reply. I will have to look for the cite to
`that.
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`But also one other argument that I would like to
`raise with respect to that is you also have to look at the scope
`of the claims. The scope of the claims requires at least a
`portion of which is released above pH --
`JUDGE BONILLA: Right, so I think I understand
`your point. As long as there is some that is retained and some
`that goes past the stomach, that it would meet the claim?
`MR. PATEL: Yes, and also --
`JUDGE BONILLA: The point is, is there any
`evidence of record, because the burden is on Petitioner here, is
`there any evidence of record that the enteric coating would
`have remained intact, and at least in enough capacity, that it
`would make it through into the stomach. What evidence do we
`have for that?
`MR. PATEL: I think we're looking at -- I think we
`have to shift the framework in terms of whether it has to pass
`through the stomach because the claims are not so limited.
`They describe at least a portion of naproxen being released at
`a pH of greater than 3.5.
`So, by definition, once -- the enteric coating is
`only going to start degrading or dissolving at a pH greater than
`3.5. So the fact that there is sodium bicarbonate there, we
`don't think that the sodium bicarbonate would degrade the
`enteric coating, but even assuming that some of it dissolved
`because of the sodium bicarbonate being present there, it is
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`because the pH has increased above 3.5, which is what the
`patent claims themselves require.
`JUDGE BONILLA: Well, the WO '185 makes it
`sound like when you put it in solution with bicarbonate, at
`least at the level they talk about, that it would dissolve enteric
`coating. It says that several times in the reference.
`MR. PATEL: It does state that but, again, it is a
`very different medium that it is being placed in. It is being
`placed in enteric-coated granules. Again, here the claim
`requires a tablet.
`So the enteric coating would be much thicker than
`the granules that you are looking at in the WO '185 patent
`where they are taking enteric-coated granules out of a capsule,
`they are tiny, and putting it into a bath of sodium bicarbonate
`explicitly for the purpose of removing that enteric coating.
`A person of ordinary skill in the art would
`recognize that the use of sodium bicarbonate in a solid powder
`coating, in this manner, is very different. That teaching or
`that example in WO '185 would not be applicable to this type
`of situation.
`So just to summarize the three points there. One,
`the structure is different from what is disclosed in WO '185 so
`that the sodium bicarbonate and esomeprazole would dissolve
`out first.
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`Two, we have a tablet formulation versus the
`capsule and the tiny granules.
`And, three, the claim limitation itself doesn't say
`anything about release in the small intestine. It just requires
`that it be released at a pH of greater than 3.5. And that would
`be met whether the sodium bicarbonate was there and it
`happened, which we don't think it would, in the lower stomach
`or in the small intestine.
`JUDGE BONILLA: So your position, I think, if
`I'm understanding it correctly, is that if the bicarbonate is
`working to break down the enteric coating, it by definition is
`at a pH that is higher than 3.5. Is that what you're saying?
`MR. PATEL: Yes.
`JUDGE BONILLA: And, again, if you can point
`out where you argue that in the papers, that would be helpful.
`MR. PATEL: Okay. And the WO '185 patent also
`does contemplate the use of sodium bicarbonate in acidic
`environments. It talks about putting it in a solid form and
`administering it into the stomach, which, of course, is an
`acidic environment.
`Then we had the question of would a person be
`motivated to replace diclofenac and piroxicam with naproxen.
`And I think we talked about this in view of Chandramouli
`which disclosed that they were all well known, common and
`similar with respect to therapeutic efficacy.
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`Although the '225 patent disclosed diclofenac and
`piroxicam, Chandramouli discloses all of the dosages and the
`properties of these various NSAIDS, and there is nothing in
`there that shows that diclofenac and piroxicam are necessarily
`closer to each other in properties versus naproxen. Naproxen
`was well known. It was characterized and has been available
`since 1976.
`JUDGE BONILLA: Can we talk about this a little
`bit? I see you are getting this from table 2 in the
`Chandramouli reference. This is on page 35 of that reference.
`It talks about the different NSAIDS that were known,
`including the two that are at issue in the '225 patent and also
`naproxen.
`One of the arguments that Patent Owner raises is
`that because the dosage is so much higher, it is anywhere from
`five to 10 times higher for a recommended dose, that it would
`start to affect pill size, and one wouldn't have a reasonable
`expectation of success in making this thing because it would
`start to be too big to be a tablet that you would swallow.
`Can you address that argument?
`MR. PATEL: Sure. Absolutely. And we have a
`demonstrative for that as well, and that is right here in slide
`60. These are using the Plaintiff's own numbers. And here we
`have 150 milligrams of naproxen -- you could go up to 500 --
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`sodium bicarbonate, and five milligrams esomeprazole in this
`case gets you a 312 and a half milligram tablet.
`Tablets that have over one gram of active
`ingredient are very common. So we think that a person of
`ordinary skill in the art would still be able to design a tablet
`that can be swallowed.
`JUDGE BONILLA: So they would have to know
`that they picked the smallest amount of everything there,
`basically the smallest amount of the two drugs and then the
`least amount of sodium bicarbonate that would be shown to be
`active as in the WO '185?
`MR. PATEL: In this example we took the lower
`end of the range.
`JUDGE BONILLA: But Patent Owner then has us
`look at the upper end of the range, which is seven grams, and I
`can't imagine somebody taking a pill that's seven grams.
`MR. PATEL: And there are disclosures of ranges
`but I think the full -- a person of ordinary skill in the art
`would look at the full disclosure of the range. And if you look
`at the lower end, you are looking at 312 milligrams.
`But the point at the end of the day is that you are
`going to get a tablet that is well -- around -- smaller than one
`gram in size, and those are common. Your multivitamins, all
`of those types of tablets are over a gram. And, moreover, the
`size of the tablet is really not a claim limitation either.
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`JUDGE BONILLA: Well, it goes to the Patent
`Owner's argument about reasonable expectation of success.
`You wouldn't -- I mean, you have to basically do a little bit of
`a rigmarole to make sure you're not going to have the PPI
`break down.
`So if it starts to mean the tablet would be too big,
`then that can go to reasonable expectation of success. Right?
`MR. PATEL: Understood in that sense. But,
`again, the naproxen, the amount, even if it is going up to 500
`milligrams, you are using very little esomeprazole. And the
`sodium -- it is really what is the ratio of the sodium
`bicarbonate with the esomeprazole that, you know, is the
`factor that I think a person of ordinary skill in the art would
`be worried about.
`And here you can see that, you know, for five
`milligrams esomeprazole, you are only using 157.5. So you
`are still going to be well within the one gram range. This is at
`312.5. I'm assuming here that, you know, you add another
`enteric coating and some other excipients and you are still at
`about one gram, which is perfectly fine for an oral tablet.
`The other point I would like to mention -- I don't
`think we need to look at this slide -- is that also in
`determining how much sodium bicarbonate to use, versus the
`esomeprazole, we talked about two options that are disclosed
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`in the prior art. One is using the alkaline compound and the
`other is enteric coating.
`And I know the Board didn't look at the Pilbrant
`article and didn't institute the petition based on the Pilbrant
`article, but it also taught that even if there is no -- even if
`there isn't anything protecting the omeprazole, or
`esomeprazole, 44 percent of it would still be available.
`So in determining how much bicarbonate to use, a
`person of ordinary skill in the art would have had within their
`grasp the ability to adjust the amount of esomeprazole versus
`bicarbonate necessary to make an appropriate size pill.
`So unless the Board -- oh, yes, I think the cite for
`the enteric coating the Board asked about is on our reply in
`support of the petition at page 13 --
`JUDGE BONILLA: And that's in relation to which
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`thing?
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`MR. PATEL: -- and page 15, which is --
`JUDGE BONILLA: Is this the motivation to
`substitute the NSAIDS?
`MR. PATEL: No, this is -- oh, this is using the
`bicarbonate alongside the enteric coating, why that wouldn't
`degrade the enteric coating.
`And then in our claim chart for ground 4, in Lupin
`Exhibit 1035, on page 1, we cited table 2 of Chandramouli for
`the substitution of naproxen for the diclofenac.
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`JUDGE BONILLA: Okay.
`MR. PATEL: And we would also like to put into
`the record page 1 of our corrected petition for inter partes
`review, the second paragraph that discloses -- that discusses
`the interchangeability of naproxen for what is disclosed in the
`'225 claim.
`JUDGE BONILLA: Thank you.
`MR. PATEL: So for all of those reasons, Your
`Honor, we believe that a person of ordinary skill in the art
`looking at the '225 patent, Chandramouli and WO '185, which
`are all directed to the same problem, preventing gastric acid
`injury in a patient, providing prophylactic effect to a patient
`who is taking chronic NSAIDS, that it would have been
`obvious to reach the claims of the patents in suit that have
`been instituted.
`JUDGE BONILLA: All right. You have about 14
`minutes left. I will go ahead and add it so you will have 29
`minutes, if you wish.
`MR. PATEL: Okay.
`JUDGE BONILLA: You don't need to take it all,
`but you have it if you like.
`(Pause)
`MR. MONROE: Good morning Your Honors.
`Once, again, James Monroe on behalf of Pozen. I would like
`to share a few thoughts using my slides and then I would like
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`to turn to addressing some of the comments made this morning
`by Lupin.
`
`I will skip a few slides as I go along. First, I
`would like to note on slide 3, the summary of the invention of
`the '996 patent and '190 patent, and in particular it discusses
`
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