Trials@uspto.gov
`571-272-7822
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`Paper No. 42
`Entered: April 20, 2015
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`BIODELIVERY SCIENCES INTERNATIONAL, INC.,
`Petitioner,
`
`v.
`
`RB PHARMACEUTICALS LIMITED,
`Patent Owner.
`____________
`
`Case IPR2014-00325
`Patent 8,475,832 B2
`____________
`
`Held: March 20, 2015
`____________
`
`
`
`
`BEFORE: ZHENYU YANG, JACQUELINE WRIGHT BONILLA,
`and TONI R. SCHEINER, Administrative Patent Judges.
`
`
`
`The above-entitled matter came on for hearing on Friday,
`March 20, 2015, commencing at 1:01 p.m., at the U.S. Patent and
`Trademark Office, 600 Dulany Street, Alexandria, Virginia.
`
`
`
`571-272-7822
`
`
`
`
`Paper No. 42
`Entered: April 20, 2015
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`BIODELIVERY SCIENCES INTERNATIONAL, INC.,
`Petitioner,
`
`v.
`
`RB PHARMACEUTICALS LIMITED,
`Patent Owner.
`____________
`
`Case IPR2014-00325
`Patent 8,475,832 B2
`____________
`
`Held: March 20, 2015
`____________
`
`
`
`
`BEFORE: ZHENYU YANG, JACQUELINE WRIGHT BONILLA,
`and TONI R. SCHEINER, Administrative Patent Judges.
`
`
`
`The above-entitled matter came on for hearing on Friday,
`March 20, 2015, commencing at 1:01 p.m., at the U.S. Patent and
`Trademark Office, 600 Dulany Street, Alexandria, Virginia.
`
`
`
`
`Case IPR2014-00325
`Patent 8,475,832 B2
`
`
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`APPEARANCES:
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`ON BEHALF OF THE PETITIONER:
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`
`
`ON BEHALF OF PATENT OWNER:
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`
`DANIELLE L. HERRITT, ESQUIRE
`McCarter & English
`265 Franklin Street
`Boston, Massachusetts 02110
`
`DANIEL A. LADOW, ESQUIRE
`Troutman Sanders LLP
`The Chrysler Building
`405 Lexington Avenue
`New York, New York 10174
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`Case IPR2014-00325
`Patent 8,475,832 B2
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` P R O C E E D I N G S
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`JUDGE YANG: Good afternoon and welcome everyone.
`This is the oral hearing in the case of Case Number IPR2014-00325
`between Petitioner BioDelivery Sciences International, Inc. and the
`owner of U.S. Patent Number 8,475,832, RB Pharmaceuticals
`Limited.
`Would counsel please introduce yourselves, please, starting
`with Petitioner.
`MS. HERRITT: My name is Danielle Herritt. I'm
`representing BioDelivery Sciences.
`MS. FREEMAN: My name is Kia Freeman, also
`representing BioDelivery Sciences.
`JUDGE YANG: Thank you. Welcome.
`MR. LADOW: Good afternoon, Your Honors. With me at
`the table here is Magnus Sessunger from my firm, Chris Haley who is
`helping with the slides and my lead counsel, James Bollinger.
`MR. BOLLINGER: Good afternoon, Your Honor.
`JUDGE YANG: Thank you. Welcome.
`So we have just a couple of administrative matters before we
`begin. Per our trial hearing order that went out on March 3rd, each
`party has 45 minutes to present its argument.
`In this case, Patent Owner, you didn't file any motion to
`amend, so we're here just to decide the patentability of the challenged
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`Patent 8,475,832 B2
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`claims. On that issue, Petitioner bears the burden to show
`unpatentability, so Petitioner will proceed first and followed then by
`the Patent Owner.
`Petitioner, you have the option to reserve time for rebuttal,
`but during your reserved time you can only rebut what the Patent
`Owner argued.
`Both parties also submitted demonstratives, so when you
`discuss the demonstratives, please identify each slide you're referring
`to by the slide number so that later when we read the transcript it is
`clear what you were talking about. Okay?
`Any questions?
`MR. LADOW: No, Your Honor.
`JUDGE YANG: Okay. Then, Petitioner, would you like to
`reserve any time for rebuttal?
`MS. HERRITT: I think I'll take about 20 minutes on my
`prima facie case and I'll reserve 25, if needed, for the rebuttal.
`JUDGE YANG: Okay. Very well. You may begin.
`Please proceed.
`MS. HERRITT: Would you like to give them copies of the
`demonstrative?
`MS. PROCTOR: May we provide demonstrative to the
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`Board?
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`JUDGE YANG: Whenever you're ready.
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`Patent 8,475,832 B2
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`MS. HERRITT: Thank you. Good afternoon. May it
`please the Board, my name is Danielle Herritt representing
`BioDelivery Sciences.
`Interesting thing about this case, in this case each and every
`recited limitation of the claims is disclosed in the applied reference,
`Labtec. RB doesn't refute that. You're going to hear a lot from RB
`today that the claimed film requires oral transmucosal absorption,
`perhaps mucoadhesion, perhaps bioequivalence or substantial
`bioequivalence.
`But here is the claim, and this is what it says -- there's three
`parts. There's a preamble, an orally dissolving film formulation, there
`is the components of the film formulation, buprenorphine and
`naloxone, and there's a wherein clause which provides some
`pharmacokinetic ranges, which are to be met.
`JUDGE YANG: Counsel, in the petition the Petitioner
`argued that the wherein clause shouldn't be given any patentable
`weight and the Patent Owner, of course, just disagreed. I don't recall
`seeing any response in the reply. Does it mean you agree or if not,
`what are you --
`MS. HERRITT: I decided to reply to their arguments in the
`response to be responsive to their arguments. It doesn't matter for the
`purposes of this, because Labtec has all of these elements. So I
`decided to spend my time responding to their arguments, but I do not
`agree.
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`JUDGE YANG: You do not agree, but you decided that it
`doesn't matter either way.
`MS. HERRITT: Yes. I'm going to spend my time talking
`about -- if that's all right.
`JUDGE YANG: That's fine.
`MS. HERRITT: So I'm just going to spend a few minutes
`talking about what the '832 tells us about these claims and then what
`Labtec says.
`So what does '832 tell us about these claims? They tell us
`that currently in the prior art there is Suboxone tablets and they're an
`orally dissolvable tablet. It looks kind of similar to our preamble
`except for film formulation. The tablet provides a combination of
`buprenorphine and naloxone. That's slide 4, excuse me.
`Slide 5. That the tablet that -- their film is going to provide
`a bioequivalent effect to Suboxone from their description. Let's see
`what we're being bioequivalent to. In Table 2 we have the prior art
`pharmacokinetic parameters of the tablet.
`Okay. So let's go back to Claim 15 for a minute. There's
`nothing special about this claim. There's no specific ingredients
`recited other than buprenorphine and naloxone. There's no specific
`properties, local pH dissolution times or dimensions or --
`JUDGE BONILLA: Is it correct that one of skill in the art
`would have known that the Suboxone had to be done separately in
`order to achieve those Cmaxes?
`MS. HERRITT: Well, I guess if --
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`JUDGE BONILLA: If you swallowed it instead, for
`example, could you ever achieve those Cmaxes?
`MS. HERRITT: Excellent question. Let's go to
`inoperability. You could certainly achieve those.
`JUDGE BONILLA: The drug that's actually sold in the
`market, if you swallowed it, you could achieve those Cmaxes.
`MS. HERRITT: Well, let's see what they said. Let's take a
`look at RB's argument.
`And before I begin, I will point out that Labtec is an orally
`dissolving film and on cross, the expert did admit that orally
`dissolving films are dissolved and not swallowed and that is what it's
`disclosed in Labtec.
`Okay. So this is their argument. They say, due to its much
`lower bioavailability for oral delivery, it couldn't possibly achieve
`these values compared to oral transmucosal. So let's see if they're
`swallowed whole. Let's go to slide 40.
`Even if they were swallowed whole, which is not the
`disclosure of Labtec -- hold on one second. We asked them, what is
`the mean absolute oral bioavailability of buprenorphine orally, if it
`was swallowed? I'm going to say anywhere from 5 to 14 percent.
`Okay. Keep that number in your mind.
`And what does he say about -- the next slide. And what
`does he say about Exhibit 2007? It's his exhibit that he actually relies
`on for this opinion that we just saw. It says, hmm, the mean absolute
`bioavailability of Suboxone sublingual tablets was 13.6. And,
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`remember, that's what we're bioequivalent to. That's what these
`ranges are. So we asked him about this.
`JUDGE BONILLA: I'm sorry, just so I understand, so even
`when it's done sublingually, it's still only 13.6.
`MS. HERRITT: This is RB's clinical data and their exhibit
`that they relied on.
`JUDGE YANG: In the same exhibit you have Exhibit 2007
`there, right? Yeah, this is the same exhibit. The Patent Owner
`actually quotes a different part of it.
`MS. HERRITT: That's correct.
`JUDGE YANG: It says the use of Suboxone by the oral
`route is, therefore, inappropriate. So these two -- what you're saying
`is it doesn't matter if you take it orally, you would have achieved
`similar bioavailability.
`MS. HERRITT: Yes.
`JUDGE YANG: And then somewhere else, the same
`document said you shouldn't do that. Do we have --
`MS. HERRITT: Well, they may have said you should --
`JUDGE YANG: -- reconcile these?
`MS. HERRITT: Oh, sorry. They may have said that for a
`number of reasons. Their argument, if you go back to their actual
`argument is, due to its much lower bioavailability, because these
`bioavailabilities are so different, so different you would never
`swallow it.
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`JUDGE BONILLA: Are you disputing that they are
`different, that it isn't absorbed better when you do it sublingually?
`MS. HERRITT: I am saying that my argument is they're
`both orally dissolving films, but their argument that you couldn't
`possibly swallow it, if you did swallow it, and their expert actually
`tells us that you can't and is not aware of a film that you swallow, and
`we can bring the slides up if you want the testimony.
`But even looking at their argument, if you did swallow it,
`which isn't the disclosure of Labtec, you can still make it, because he's
`telling us -- give me the next slide -- the 5 to 15 percent or 5 to 14
`percent, that's the bioavailability that's supposed to be so different
`from what we're trying to achieve and where's the Suboxone tablet?
`And we asked them about this on cross. We asked them. So
`could we go to the next slide? Do you agree that the mean absolute
`bioavailability of buprenorphine from sublingual Suboxone is 13,
`because he had just said a range that was around it. We're asking him,
`how is it different? And he says, actually this would be another area
`of the exhibit where, even though this comes from the manufacturer --
`which is not the case, RB is not the manufacturer, but it's RB's clinical
`data -- where I would say that I somewhat disagree.
`So when confronted with evidence that he relies on, RB's
`expert disputes RB's own data and the document he relies on, his
`opinion. Apparently he relies on portions of RB's data that conform to
`his opinion and he doesn't support it. It's wrong. And there's many
`instances of this.
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`They're not using there expert to explain the references to us.
`The Board understands the references. And they're not disputing what
`they say. They're using their expert to filter, to filter the references
`and tell you, hey, ignore, ignore this evidence, ignore Labtec and, you
`know, then read in what I'm telling you to read in, even though the
`phrase doesn't appear once, oral transmucosal absorption in the
`specification.
`JUDGE YANG: Okay, counsel. So the way I see it is we're
`here to decide probably two main variables, first, whether the
`challenged claims are limited to the oral transmucosal absorption.
`The other one is whether Labtec is limited to films that's absorbed
`through the GI tract only.
`I get that you are trying to tell us earlier that it's not. The
`challenged claims shouldn't be limited to absorption through mucosal
`membrane. We haven't decided that issue, of course. So my question
`is purely a hypothetical. Let's say Patent Owner persuades us more
`than you do here and we decide that it actually does require mucosal
`absorption, how would you say, are you going to lose, are you going
`to win?
`
`MS. HERRITT: We still win either way. Let's first go to
`solely concerns OTA, their argument, that we read in, not construe
`claims from -- not construe words from the claim, but we read in an
`embodiment from the specification that I'm not -- I haven't seen
`anyway in the specification.
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`Let's just say that -- no, let's go to the next one. Let's go to --
`so RB presents two arguments in the '832 about solely concerning
`OTA. They say, look, we're OTA and we're different for three
`reasons. This is their reply brief at 4. RB argues a person of skill in
`the art would understand oral transmucosal linked to the film from
`three things, the desire to mimic Suboxone tablet. That's what's
`different.
`Well, that's what Labtec says, of course, that they're
`mimicking Suboxone tablets bioequivalent the desired dissolution
`time. Slide 22. Because they're implying that it's swallowed so quick,
`it can't be transmucosally absorbed. Well, actually on cross, and it's
`true in the spec and I can show it to you if you want, the dissolution
`times are overlapping and, in fact, go up to 60 to 90 minutes in
`Labtec.
`
`And, three, the desire to select a pH that achieves its goals.
`That's how we know it's OTA and not Labtec. Well, slide 23. Does
`Labtec disclose controlling pH to adjust drug absorption? They do,
`and that is shown in our briefs.
`JUDGE BONILLA: But do they disclose it controlling the
`pH in the way it's relevant that matters to the point of --
`MS. HERRITT: Yeah. Do you want to go to the Labtec? I
`think it's under something that says like adjusting the pH or
`bioequivalence or something like that.
`JUDGE BONILLA: I mean, if it simply says to adjust the
`pH for the purpose of bioequivalence, does that get you -- is that
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`enough to tell you what you need in a situation where you need
`sublingual in order to get there?
`MS. HERRITT: Oh, yeah. Yeah, yeah. So let's do -- so
`were you reading -- in this hypothetical were you reading in
`sublingual or oral transmucosal absorption, just so I can answer the
`right question, because I don't think they've argued sublingual.
`JUDGE YANG: Right.
`JUDGE BONILLA: I guess that's my putting that in there.
`MS. HERRITT: No, that's fine. I just want to answer it.
`JUDGE BONILLA: What is the difference, can you explain
`that to me?
`MS. HERRITT: Well, you could be sublingual. It could be
`buccal. It could be on the tongue. There's lots of areas.
`JUDGE BONILLA: And all of this would be considering
`mucosal.
`MS. HERRITT: Yes, sublingual.
`JUDGE BONILLA: So what is the film that's not mucosal,
`how does that work exactly, if it's none of those things?
`MS. HERRITT: Oh, well, RB's expert actually said he
`hasn't heard of a single film that isn't dissolved in the mouth that's
`swallowed.
`JUDGE BONILLA: Well, Labtec teaches that it's
`nonmucosal and it's a film.
`MS. HERRITT: Oh, what is it?
`JUDGE BONILLA: Yes.
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`MS. HERRITT: Nonmucosal. Not mucoadhesive. No, I
`don't think so.
`JUDGE BONILLA: Maybe I'm not using the proper term.
`MS. HERRITT: Sure.
`JUDGE BONILLA: Whatever it is in Labtec it says it's
`nonmucosal, right?
`MS. HERRITT: Oh, you're saying non-mucoadhesive.
`Okay. I think that's what your question is. Okay.
`JUDGE BONILLA: I'm trying to decide how that
`distinguishes from sublingual versus what you were describing as
`more than sublingual.
`MS. HERRITT: I mean, I certainly don't make the
`connection and the inventors say that if something has to be
`mucoadhesive to be orally transmucosally absorbed, they have it one
`time. The one time they talk about adhesion in their specification of
`the '832, they're talking about so it will stick in the cheek so someone
`can't take it out.
`JUDGE BONILLA: So that's just a sticky component, not
`location, where it is. It could be anywhere in the mouth.
`MS. HERRITT: Can you go to that part of the '832 just to
`make sure, but I don't think so. It's in the background.
`JUDGE BONILLA: Is it correct that the tablet that we're
`talking about, that has to be sublingual, though, in order to read it --
`reach its --
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`MS. HERRITT: The label says that it's sublingual.
`Interesting, not mucoadhesive.
`JUDGE BONILLA: Okay. But it does say sublingual. Is
`that required --
`MS. HERRITT: What do you mean, on the label how you
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`take it?
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`JUDGE BONILLA: Right.
`MS. HERRITT: Yeah, I think it does say you put it under
`your tongue. It's sublingual.
`JUDGE BONILLA: And if you don't do it that way, does it
`still work to get those Cmaxes?
`MS. HERRITT: Oh, I have no idea.
`JUDGE YANG: Well, that --
`MS. HERRITT: I would guess, but --
`JUDGE YANG: That exhibit you put on earlier, Exhibit
`2007, the data sheet -- the tablet data sheet, you pointed out the
`bioavailability, the overlapping bioavailability, but in the same data
`sheet there is language saying you shouldn't -- the use of Suboxone by
`the oral route is, therefore, inappropriate. Tablets are for sublingual
`administration.
`MS. HERRITT: Well, they -- the clinical trials where they
`always put it under the tongue, so they're going to tell the patient do it
`the way that we know it works, but I don't read that as you have very
`different bioavailability. That's their theory. You couldn't possibly
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`swallow it. By their evidence, you could. They say 5 to 14 percent
`absorption perorally and their own label says 13 percent.
`Look, I think the best way to like crystallize the issues is
`this, imagine like two films, two orally dissolving films. The claim
`says orally dissolving film. Labtec says orally dissolving film. They
`both include buprenorphine and naloxone. They both include the
`same amount. They both include the same dissolution times in your
`mouth. Their expert said if you have an orally dissolving film and
`there's buprenorphine in it, it's going to be absorbed. Okay. So --
`JUDGE BONILLA: Is it correct that it's your position that
`you have a film and whether it's micro mucosal adhesive or not
`doesn't make any difference in terms of its bioavailability?
`MS. HERRITT: There has been no evidence that it is. In
`the '832 they say it should be mucoadhesive, so these are people who
`are -- have addiction issues, right? So you can't remove it and cook it
`up and inject it.
`And, again, on cross the expert did say the tablet is not
`mucoadhesive. So if you're copying the tablet, like Labtec tells you to
`do --
`
`JUDGE BONILLA: But the tablet, the film would be
`similar, correct, in terms of it would -- if it's not mucoadhesive, you
`would swallow whatever gets dissolved, right? That would be the
`way that it would get into your GI tract.
`MS. HERRITT: Yeah, the tablet like the films, are orally
`dissolved and you hold it in your mouth for as long as they tell you to
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`do. The same in Labtec. It's in your mouth. It goes in your mucosa,
`gets absorbed and you swallow it.
`JUDGE BONILLA: And does it -- and it goes through the
`mucosa, not through the GI tract. Is that what happens to the tablet?
`MS. HERRITT: Well, that's a great question. There
`certainly is mucoadhesive, oral mucoadhesive absorption in both and
`Labtec says it. They said we might retard it to get bioequivalence,
`which, by the way, it's exactly what '832 did.
`JUDGE BONILLA: Well, I'm trying to figure out whether
`the tablet is different than what's in Labtec. I mean, maybe the -- are
`they the same in the sense that the mucoadhesive component doesn't
`make any difference, is that where you're driving at?
`MS. HERRITT: Well, that's a great question. So let's go to
`the mistake slide, because I think this is going to answer your
`question, the mistake slide. So when they say ignore the disclosure of
`Labtec -- can you put up their argument? It's their slide 26. I think
`this is going to do it.
`What's their argument? They say Table A of Labtec lists 19
`different brand name drugs of interest for each of these and their
`respective PK profiles. Each of these brand name products, with the
`exception of Suboxone and Subutex, use the GI tract as the metabolic
`and bioabsorption pathway. It's a pretty strong statement. It didn't
`have facts supporting that opinion. So we asked them about it.
`We said -- let's just take one. Let's take the film that they
`actually demonstrated bioequivalence for in Labtec. That's
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`ondansetron. We said, well, what about ondansetron? That's the
`second entry in Table A. Are you aware that ondansetron orally
`dissolving tablets are in a Zydis formulation? I seem to recall Labtec
`seeing Zydis. Okay. And then they talk about what is this.
`Are you aware that one of the criteria of the drugs for a
`Zydis formulation is the drug be absorbable through mucosa? I
`believe this is a condition for the use of Zydis. So apparently those
`aren't the only two mistakes that we can ignore.
`JUDGE YANG: Can we just have an identification of this --
`MS. HERRITT: Oh, absolutely. This is the -- can you tell
`us the exhibit?
`MS. PROCTOR: Exhibit 1028 at pages 130 and 131.
`MS. HERRITT: So apparently it's not the only mistake,
`which apparently we can ignore, even though the law tells you it's art
`from everything it discloses.
`So if you look at the example of Labtec on 32. Look at that.
`It's bioequivalent or substantially bioequivalent. They have a drug
`that's orally transmucosally absorbable they made into a film version.
`It's bioequivalent. What is missing?
`And the interesting thing about this is they talk about how
`they used the base to retard absorption. That's a couple of the tricks
`that they have, pH, they use the base. But if you look at Table A, item
`2, the tablet, it says -- for the ODT, it's ondansetron base. So they did
`what was in the tablet.
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`So in our -- to bring it back home to your question, Judge
`Bonilla, when we -- when you go forward to copy the tablet, what did
`they do? They copied the pH. There's no expectation that
`mucoadhesive matters. The tablet is not mucoadhesive. They
`admitted that on cross. They did exactly what Labtec says to do.
`They copied the tablet.
`JUDGE BONILLA: Well, let's switch gears a little bit. Is it
`correct that Labtec is -- that it's teaching a film that is limited to
`something that's absorbed in the GI tract?
`MS. HERRITT: No. Let's go to -- let's talk about Labtec is
`not limited to peroral dosage. Okay. Hold on. Let's go to -- I'm
`going to skip forward to --
`JUDGE YANG: You asked for 20 minutes? You have a
`minute and a half left.
`MS. HERRITT: Okay. Well, I'd like to answer your
`question, so I'll take up my rebuttal time. That's fine, if that's okay.
`JUDGE YANG: Okay.
`MS. HERRITT: Okay. Let's look at what Labtec says.
`Labtec says -- let's look at the second box. We're making a film that
`mimics the pharmacokinetics and follows the same metabolic
`bioabsorption pathways as the innovator's product. The innovator's
`product is the Suboxone tablet. And he said on cross, yeah, it's
`absorbed both tranmucosally and if it's swallowed, it will be absorbed
`in the GI.
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`Well, that's what the film is and the invention provides, to
`answer Judge Bonilla's question, a film -- orally disintegrating film
`with an active pharmaceutical agent that's absorbable through the
`mucosa when dissolved and means for retarding absorption.
`Retarded. Not no absorption.
`And in the '832, remember, they didn't maximize absorption
`in the examples, if you look at them. Maximizing is a definition in
`there. The other definition is optimizing and optimizing means go up
`or down, make it bioequivalent. And the examples, they had to lower
`the pH from 5.5 to 3.5, to get this, lower the transmucosal absorption.
`It was too high for buprenorphine and naloxone. They had to lower
`that to be bioequivalent. It sends more to the GI tract if it's not
`absorbed.
`Whether you call something an OTA film because 13.6
`percent, even if all of it was absorbed, or 10 percent, whatever's
`absorbed in the mucosa and 90 goes to the GI tract, would they call it
`a GI film because 90 goes to the GI tract, but the same amount was
`absorbed in the mucosa. It's the same film and they accomplished --
`let's see what the next page says, the next slide, slide 30.
`Here it is. This answers your question prior. For other
`drugs, which are more permeable through the oral mucosa, or for
`which only a small amount of mucosal absorption can be tolerated due
`to bioequivalence, right, they did the 5.5 example in the '832.
`Naloxone and buprenorphine are too high. You can adjust it, the very
`second thing to do.
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`Oh, the first thing, sorry, pH adjusting agents that adjust the
`pH of the environment surrounding the dosage form to a pH that
`renders the active agent less permeable. That's the local pH. It's
`exactly, exactly what '832 did.
`And I think we have one more slide. And here's my point,
`so if you're talking about you want to deliver 60 percent to the GI
`tract, if at most the tablet we're copying has 13.6 percent absorption,
`we're delivering 80 percent to the GI tract in that tablet, in the film.
`JUDGE BONILLA: Does that suggest, however, that the --
`because it says greater than 60 and so on percent. Is that -- you could
`read that as saying that, for example, 40, 30 percent or whatever isn't
`absorbed at all.
`MS. HERRITT: I have not heard that argument and they
`talk about retarding absorption. It's an embodiment. Sure, they have
`embodiments. It's right here, a hundred percent. That's an
`embodiment.
`JUDGE BONILLA: The only thing that Labtec talks about
`mucosal absorption, like what percent of mucosal absorption or any
`type of mucosal absorption. It just says that that's less or less than a
`hundred percent of -- through the GI.
`MS. HERRITT: That's correct. Well, they talk about
`adjusting the mucosal absorption, so I think that if you're going to
`adjust it, I think it's fairly well implied. I think that that is exactly
`what they're trying to do. They're trying to take a tablet and make a
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`film that's bioequivalent and you have to make a distinction here
`between delivering versus absorbing.
`They're not saying here you're going to absorb. They're just
`saying you're delivering it. So if you're only delivering 60 percent or
`it's like greater than 60, so. You know, and what happens to the other
`40? There's testimony they don't spit it out. The film is not spit out,
`either for the '832 films or the films of Labtec.
`As BDSI's expert opined, the bioavailability of
`buprenorphine of an orally dissolving dosage form results from
`absorption in both the mouth and the GI tract and their evidence
`supports that in their testimony. If you have -- what did they say for --
`if you have 13.6 percent absorption, if you have 20 percent absorption
`and you send 80 in the GI tract, they've already said the absorption in
`the GI tract will be 5 to 15 percent.
`Does it now magically not get absorbed in the GI tract? No,
`it's swallowed and what's going to be absorbed is absorbed.
`So with that, I think we should maybe hear what Reckitt has
`to say and then we'll come back and talk about that. Oh, but maybe
`one more thing. Should we talk about expert testimony? Let's talk
`about expert testimony or -- is that okay?
`JUDGE YANG: Why don't we --
`MS. HERRITT: Do it when we come back? Thank you.
`MR. SESSUNGER: Can we hand up slides, too?
`JUDGE YANG: Thank you.
`Whenever you're ready.
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`MR. LADOW: Thank you. Good afternoon. Dan Ladow
`for the Patent Owner.
`Your Honors, there's two fundamental mischaracterizations
`that underlie the Petitioner's case here and you just heard both of
`them. The first one is, is that Labtec is about, in part, oral
`transmucosal absorption and you heard counsel say it, Labtec is not
`just about GI absorption. She says it's just about delivery. Any fair
`reading of Labtec is going to tell you the opposite.
`In a few minutes I'd like to try to take you through that.
`JUDGE BONILLA: Well, let's say we assume for the sake
`of argument that we buy your discussion that Labtec is limited to
`non-mucosal adhesive. So we have the tablet. Is that all through
`mucoadhesive or is it some of it, it just gets dissolved and is absorbed
`through the GI tract?
`MR. LADOW: Yeah. The way that works, Your Honor, is
`that Labtec defines non-mucoadhesive as a film which is not absorbed
`through the oral mucosa.
`JUDGE BONILLA: I'm trying to -- so if you make a
`non-mucosal film having the drug and you're trying to get something
`that's bioequivalent to the tablet, I'm trying to figure out if the tablet is
`limited. What happens with the tablet?
`MR. LADOW: Yes.
`JUDGE BONILLA: How does it get its bioavailability? Is
`that -- because my understanding is it's sublingual and there was some
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`confusion, and perhaps it was only mine, about non-mucosal
`adhesiveness versus sublingual.
`MR. LADOW: No, I don't think you're confused at all. I
`think you have it exactly right. So what I was trying to say is that
`Labtec is -- when Labtec says non-mucoadhesive, it's an umbrella
`term for not OTA is what I'm saying.
`The Suboxone tablet, you're absolutely right, it's not really a
`mucoadhesive drug product like Suboxone film is. The way that the
`tablet works, which is all throughout the literature and in the
`prescribing information, is that it's sublingual. The patient puts it
`under their tongue and everybody understands in the art that the drug
`is absorbed transmucosally and that the bioavailability values that you
`obtain with the Suboxone tablet is from OTA.
`Now, that's not to say that you couldn't get a little bit of
`bioavailability from what is swallowed, but it's going to be very little
`and what I wanted to say, but I didn't want to interrupt, Your Honor --
`JUDGE YANG: Finish and I'll ask you a question.
`MR. LADOW
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