trials@uspto.gov
`571-272-7822
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`
`
`
`IPR2015-01903, Paper No. 30
`December 1, 2016
`
`RECORD OF ORAL HEARING
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`----------
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`---------
`AMNEAL PHARMACEUTICALS LLC and
`
`PAR PHARMACEUTICAL, INC.,
`
`Petitioners,
`
`v.
`
`JAZZ PHARMACEUTICALS, INC.,
`
`Patent Owner.
`----------
`
`Case IPR2015-01903
`
`Patent 8,731,963
`
`Technology Center 2800
`
`Before: HONORABLE JACQUELINE WRIGHT
`
`BONILLA, SUSAN L.C. MITCHELL, and BRIAN P. MURPHY,
`Administrative Patent Judges.
`
`The above-entitled matter came on for hearing on Friday,
`
`October 14, 2016, at 10:00 a.m., hearing room A, taken at the U.S. Patent
`
`and Trademark Office, 600 Dulany Street, Alexandria, Virginia.
`
`Reported by: Elizabeth Mingione, RPR
`
`
`571-272-7822
`
`
`
`
`IPR2015-01903, Paper No. 30
`December 1, 2016
`
`RECORD OF ORAL HEARING
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`----------
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`---------
`AMNEAL PHARMACEUTICALS LLC and
`
`PAR PHARMACEUTICAL, INC.,
`
`Petitioners,
`
`v.
`
`JAZZ PHARMACEUTICALS, INC.,
`
`Patent Owner.
`----------
`
`Case IPR2015-01903
`
`Patent 8,731,963
`
`Technology Center 2800
`
`Before: HONORABLE JACQUELINE WRIGHT
`
`BONILLA, SUSAN L.C. MITCHELL, and BRIAN P. MURPHY,
`Administrative Patent Judges.
`
`The above-entitled matter came on for hearing on Friday,
`
`October 14, 2016, at 10:00 a.m., hearing room A, taken at the U.S. Patent
`
`and Trademark Office, 600 Dulany Street, Alexandria, Virginia.
`
`Reported by: Elizabeth Mingione, RPR
`
`
`
`APPEARANCES:
`
`ON BEHALF OF PETITIONERS:
`
`
`
` RICHARD J. BERMAN, ESQUIRE
` GARY COAD, ESQUIRE
` Arent Fox
` 1717 K Street, Northwest
` Washington, D.C. 20006
` (202) 857-6000
` richard.berman@arentfox.com
` gary.coad@arentfox.com
`
`2
`
`
`
`
`
`
`
`ON BEHALF OF PATENT OWNER:
`
`
`
` F. DOMINIC CERRITO, ESQUIRE
` GABRIEL P. BRIER, ESQUIRE
` FRANK C. CALVOSA, ESQUIRE
` Quinn Emanuel Urquhart & Sullivan, LLP
` 51 Madison Avenue, 22nd Floor
` New York, New York 10010
` (212) 849-7450
` nickcerrito@quinnemanuel.com
`
`
`
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`Case IPR2015-01903
`Patent 8,731,963
`
`
`
`P R O C E E D I N G S
`
`(10:00 a.m.)
`JUDGE MURPHY: Okay. Good morning.
`Welcome back to the Board. We will now hear oral
`arguments in Case IPR2015- 01903, Amneal Pharmaceuticals
`LLC, and Par Pharmaceutical, Inc. Versus Jazz
`Pharmaceuticals, Inc.
`This case concerns patentability of certain claims
`in U.S. Patent Number 8,731,963. I'm Judge Murphy. We
`also have Judge Bonillaand Judge Mitchell on the bench
`today.
`
`Counsel, please introduce yourselves for the
`
`record.
`
`MR. BERMAN: Rich Berman, on behalf of Par
`Pharmaceutical. And with me is Gary Coad.
`MR. CERRITO: Good morning, Your Honors.
`Nice to speak before Your Honors again.
`Nick Cerrito, Gabe Brier, and Frank Calvosa
`from Quinn, Emanuel, Urquhart and Sullivan, on behalf of
`Jazz.
`
`JUDGE MURPHY: Thank you, Counsel. And
`welcome back to the Board.
`Okay. I think everyone understands the rules.
`Petitioner will go first. You have the burden of proof on
`unpatentability.
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`Each side has 30 minutes. Petitioner may reserve
`rebuttal time.
`I'm not sure if you were here last time when
`we had our new countdown clock or not, but we have a
`new countdown clock. So you'll -- if I work it correctly,
`you'll get a two- minute yellow light warning.
`So, Mr. Berman, you may reserve rebuttal
`time. And, Mr. Cerrito, also 30 minutes for Patent Owner.
`You may not reserve rebuttal time.
`I remind everyone it's a public hearing. There
`will be a public record transcript after the hearing, as you
`know.
`
`I don't think we received any demonstratives.
`Is that correct or incorrect?
`MR. CERRITO: That's correct, Your Honor.
`MR. BERMAN: Yes. That's correct.
`JUDGE MURPHY: Okay. All right. So we
`won't have to worry about identifying slide numbers for
`the transcript, so that's fine. Let's see, what else? So I
`guess that's it.
`Mr. Berman, do you wish to -- how much time
`do you wish opening and do you wish any rebuttal?
`MR. BERMAN: Yes. I would like five
`minutes for my opening and 25 for rebuttal.
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`JUDGE MURPHY: Five and twenty-five.
`Okay. All right. With that, Mr. Berman, whenever you are
`ready, you may proceed.
`PRESENTATION FOR PETITIONER
`MR. BERMAN: Thank you, Your Honor.
`Good morning, Your Honors. The '963 patent is directed
`to restricted drug distribution systems related to Jazz's
`Xyrem drug product.
`The Board has already reviewed six related,
`restricted, drug distribution patents. And the Board has
`held the challenged claims in all six patents were obvious.
`Jazz advances the same arguments here in its
`effort to preserve the challenged claims of the '963 patent,
`but there are no material differences between the issues in
`the prior IPRs and this IPR.
`So as in the prior IPRs, the challenged claims
`here are obvious.
`The Board may recall that in the prior IPRs
`there was a lot of discussion on the public availability of
`the advisory committee art, or ACA. Thankfully here, Jazz
`has already conceded that the ACA was publicly available.
`So that's the last I'll mention of that issue.
`Regarding claim construction, as in the prior
`IPRs, Jazz again wants the Board to unreasonably narrow
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`the periodic reports term, which this time is present only
`in dependent claim 27.
`But the Board has already held that Jazz's
`proposed narrowing of the periodic reports term has no
`basis. And here Jazz's claim construction argument is a
`practically verbatim copy of its arguments in the prior
`IPRs.
`
`JUDGE MURPHY: Well, we didn't say it
`didn't have any basis. We just said we didn't agree with
`the position, basically.
`MR. BERMAN: Thank you for that
`clarification, Your Honor. Your Honors, here's Claim 27.
`And if you look at the periodic reports viewed in context,
`it's used to identify current patterns or anticipated
`patterns of abuse.
`Now, as the Board may recall from the prior
`IPRs, several types of reports are described in the '963
`patent.
`
`Figures 13A through C describe reports run at
`certain intervals, such as weekly, monthly, or quarterly.
`Figure 4B describes risk diversion reports run in response
`to a patient's request for an early refill of the drug.
`Any of these reports -- the reports described in
`Figures 13A through C, or the reports described in Figure
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`4B, can potentially identify current patterns or anticipated
`patterns of abuse, which is what this claim requires.
`JUDGE MURPHY: Mr. Berman, let me stop
`you there for a moment.
`MR. BERMAN: Sure.
`JUDGE MURPHY: What about their Enpat
`case that they cited, where there was similar claim
`language in a different patent.
`I think it was Judge Brinkema from the
`District Court who essentially construed periodic or
`periodic reports in the context of this other patent, as
`excluding ad hoc or intermittent reports, and requiring
`reports at regular intervals.
`MR. BERMAN: Yeah. I think, as Your Honor
`knows, each case stands on its own merits. And each case
`stands on the evidence presented.
`Here there is no evidence that the Patent
`Owner has presented that would lead one to think that the
`reports in Figure 4B were meant to be excluded. And, in
`fact, in this case we have intrinsic evidence that it was
`meant to be included, Figure 4B.
`JUDGE BONILLA: Can I ask a question about
`that? And you may not know -- I don't know how
`carefully you read the other case, but is there any
`
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`distinguishing factors between what was going on in that
`specification in that case and what we see here?
`Was there more language in the specification
`there to limit it?
`MR. BERMAN: I have not read that case in
`great detail, so I cannot distinguish between the two right
`now. What I can do is expound upon the intrinsic
`evidence that we have here that the '963 patent itself in its
`file history cited to Figure 4B.
`So, in the file history, at Exhibit -- that's
`Exhibit 1002 at page 2313, the applicants explicitly cite
`page 10, lines 10 through 18 of the specification.
`JUDGE BONILLA: I apologize. Can you tell
`me the name of -- sorry -- the page in that exhibit again?
`MR. BERMAN: 2313. And I'm about to put it
`on the ELMO.
`JUDGE MURPHY: And, Mr. Berman, you are
`into rebuttal time.
`MR. BERMAN: Thank you.
`I think this point merits taking a little extra
`time. So here the applicants cite page 10, lines 3 through
`18, which of course includes page 10, lines 10 through 18.
`And this is that page. It's Exhibit 1002 at page 23. And
`here you see it's referring to the numbers 406, 432, 436, et
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`cetera. And those correspond to Figure 4B, which is page
`37 of the Exhibit 1002. There is 406, 436, et cetera.
`So, as in the prior IPRs, there is no basis to
`conclude that the periodic reports term should be narrowly
`construed. Turning to obviousness, for a moment, in the
`'988 IPR, the Board held that the ACA, in view of the
`secondary reference Korfhage, rendered obvious claims 2
`and 10 of the '988 patent.
`And here there are essentially no differences
`between those claims and the challenged claims here, nor
`are there any differences in Jazz's arguments.
`So there's no reason for the Board to come to a
`different conclusion here. And I would like to reserve the
`remainder of my time. Thank you.
`JUDGE MURPHY: Okay. You'll have 23
`minutes, Mr. Berman.
`MR. BERMAN: Thank you.
`MR. CERRITO: Thank you, Your Honor, Mr.
`Brier will be handling the argument today.
`JUDGE MURPHY: Absolutely.
`PRESENTATION FOR PATENT OWNER
`MR. BRIER: Good morning, Your Honors.
`For Mr. Berman's first point for periodic reports, our
`basic position is that the word periodic has to be given
`
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`Case IPR2015-01903
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`meaning, that it means that it has to occur at some regular
`interval.
`
`If it just meant to make a report any time to
`check for potential abuse of the system, then it would just
`say reports. The word periodic would be completely
`unnecessary.
`In the part of the file record that Mr. Berman
`referred to when he referred to Figure 4B, the boxes on
`Figure 4B that were being referred to did not concern
`reports. The claim element has the elements of both
`periodic reports and evaluating those reports.
`JUDGE MURPHY: Yes. If you could put that
`up on the ELMO, and --
`MR. BRIER: Sure.
`JUDGE MURPHY: -- you know, enhance the
`view a little bit more, it would help to explain the context.
`MR. BRIER: Sure. So this is Figure 4B. And
`you see Figure 436 that was referred to in the file
`wrapper. It talks about the pharmacist evaluating patient's
`compliance with therapy and possible product diversion,
`misuse or overuse. That's the evaluation part of it.
`There's a separate box in this page that talks
`about reports, but that box wasn't cited in the section of
`the file wrapper relied upon by Par and Petitioners and
`Mr. Berman.
`
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`So this -- to the extent that they are relying on
`box 434 in Figure 4B for their argument that periodic
`means reports done at any time, that's not supported by
`the file wrapper.
`JUDGE BONILLA: Is there anything in the
`specification itself that suggests that 4B isn't something
`that's covered by the claim? That it specifically is
`excluding what is discussed in 4B?
`MR. BRIER: I don't think it's a matter of if
`it's specifically excluding. Our position is that if the
`word reports was used, that could mean any reports. It
`could be an ad hoc report. It could be a report with
`frequency.
`
`This '434 is essentially disclosing an ad hoc
`report. The word "periodic" means there has to be some
`regular frequency. And, actually, that does appear in
`Figure 13A.
`JUDGE MURPHY: Well, at least in the earlier
`case, we had multiple competing dictionary definitions.
`And I think we referenced some of those.
`I know Petitioner had referenced them. So,
`you know, you can pick your definition. But what's in the
`spec?
`
`I think what Judge Bonilla wants to zero in on
`is what in the spec teaches us or tells us that perhaps we
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`should exclude, according to your position, ad hoc or
`intermittent reports from the definition of periodic
`reports?
`
`MR. BRIER: Our position is that those are
`two different things. A report generally is a broad term
`that would include both ad hoc and periodic. But if you
`are using the specific word periodic, you are narrowing
`that. And we think that -- this is Figure 13A in the '963
`patent -- refers to weekly, monthly, quarterly reports.
`Our position is that's what periodic is referring
`to, some sort of regular report. That's why that word was
`used.
`
`If it didn't mean some regular frequency
`beyond necessary, it would just say to run reports
`generally to check for diversion. So that's our position, in
`theory.
`
`JUDGE BONILLA: I think we understand your
`position on that. In your Patent Owner response, you
`cited this case, that case that Judge Murphy reported to
`Enpat.
`
`And because you all cited it, I assume you are
`a bit more familiar with it.
`Can you indicate anything in that case that you
`say that -- that said that the specification distinguishing
`between periodic and on rest -- on request tasks supported
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`a construction of periodic, that means fixed intervals, so
`on.
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`What was in the specification in that case that
`-- was it similar to this one, where it didn't exclude
`anything in particular?
`Can you talk about that case and why that case
`is relevant to us, when we are dealing with different
`claims and different specifications and so on?
`MR. BRIER: You know, Your Honor,
`unfortunately I can't recall the specific specification, the
`patent in that case. In this case, this is column 8 of the
`'963 patent.
`Actually, there was a discussion in that
`previous case of reports done basically on request, which
`we would characterize as ad hoc reports and reports done
`with general frequency.
`And this is another portion of the specification
`of the '963 patent where it says each report has an
`associated frequency or frequencies.
`So, again, we are just -- I think that's a
`distinction --
`JUDGE MURPHY: Give us the citation for
`that, please, just for the --
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`MR. BRIER: Oh, yeah, sure. It's '963 patent,
`column 8. And the line number is line 28 to line 31, I
`believe.
`
`JUDGE BONILLA: Well, that's in relation to
`Figures 13A through C, correct?
`MR. BRIER: Correct.
`JUDGE MURPHY: Let me ask you this. We
`had pointed to -- if you look in column 6 of the '963
`patent, at about line 16, there's a discussion of Figures 4A
`and 4B.
`
`And the concept was, if a patient makes an
`early refill request, a report may be generated to test that
`to see if there's a potential abuse situation.
`MR. BRIER: Correct.
`JUDGE MURPHY: And that's not done on a
`regular interval basis. And so one of the things we had
`discussed in our earlier decision was that seems to be
`included here.
`What in the spec suggests that it's
`distinguishable from -- or not included in periodic
`reports?
`
`And my recollection -- I looked quickly at the
`Enpat case last night, and I thought it was a very specific
`discussion in that specification about the two different
`types of frequency, if you will, of reports, and why one
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`should or shouldn't be included in periodic as a
`definitional term as used in that particular spec.
`So that -- but, you know, we didn't spend the
`time that perhaps you did. So that's why we are looking
`for some assistance on that, because it didn't jump out at
`me as directly applicable on the facts.
`MR. BRIER: Sure. Well, the issue I think
`here is that in the column 6 the -- well, line 18 or so that
`Your Honor's referring to, it says generating a report.
`Again, that's a broad term that to us would
`include both the ad hoc and a periodic report. And the
`claims didn't use that broad phrase, generating report.
`The claim used the phrase, generating a
`periodic report.
`JUDGE MURPHY: But do you agree that the
`specification of '963 doesn't describe a, quote, periodic
`report, or define it, or use it in the context where it's only
`being used in the context, if you will, of Figure 13,
`regular interval, weekly, monthly reports.
`Is there something in the spec that either
`suggests that or actually comes right out and says it; it's a
`different kind of report. A periodic report is something
`different than an ad hoc report such as an early refill
`request report.
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`MR. BRIER: We believe that that language
`that we referred to in Figure 13, in the language in column
`8, that that was talking about frequency, that is talking
`about periodic reports.
`And that's the distinction, that when you are
`talking about reports at a set frequency, that's what
`periodic means.
`And again, you know, if it wasn't -- necessary
`in the claims to have some set frequency, we could have
`just said generate reports.
`The patentees used that phrase, periodic. And
`we believe it has to be given meaning.
`We think it's the meaning that you have in
`Figure 13 and you have in column 8, that it's some regular
`frequency. And we also have our expert declarants
`support that interpretation of the claims, and their expert
`declarants didn't respond to that point.
`And that's why we think that when you look at
`the patent as a whole, that there are different types of
`reports described in there. We think 4B, when it says
`generating a report because you think that someone may
`be trying to obtain the early prescription, that's a classic
`ad hoc report where a flag comes up and you are doing it
`on the spot.
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`And we think that needs to be distinguished
`between the types of reports described in Figure 13,
`column 8, where there is a regular frequency and having
`periodically, regardless of whether you have a red flag.
`You're doing the follow up on the whole system to make
`sure that there's nothing in there that looks off or could be
`potential abuse.
`JUDGE MURPHY: Okay.
`MR. BRIER: Now, for claims 24, 26 and 27 of
`the '963 patent, Mr. Berman said that there's nothing to
`really talk about with respect to combining the Advisory
`Committee Art material they rely on in the Korfhage
`reference, which they rely on to meet the computer
`architecture aspects of those claims.
`That's not true. In this case, the claim
`language in the '963 patent is slightly different than the
`claim language in the previous IPR that the Petitioners
`rely on.
`
`And here there would not have been motivation
`in the '963 patent to combine these disparate elements in
`the prior art. A person of ordinary skill in the art,
`seeking to develop a distribution system for a drug that's
`prone to abuse, misuse, and diversion would not have
`looked to this system of Korfhage.
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`When you look at the primary reference, the
`Advisory Committee materials that were relied upon by
`Petitioners, it stresses over and over and over again this
`need to have everything under a centralized database, with
`a single database with centralized control.
`And, again, you have to remember that the
`drug we are talking about here in the ACA is Gamma
`Hydroxybutyrate, or GHB, which at the time in the early
`2000s was a notorious drug. It had been documented to be
`used illicitly in drug- facilitated sexual assaults.
`And Jazz, the company that markets this drug
`today, had to basically build the system from the ground
`up to ensure that there would be no gaps in the system.
`There would be no way for people to abuse the system by
`potentially getting duplicate scripts by doctor shopping,
`things of that nature.
`So that's why they made this really closed,
`narrow, single database system to have the absolute
`paramount amount of control. And that's different than
`what's described.
`JUDGE MURPHY: Yeah, but, I mean, it's a
`single database, right? But the claims talk about multiple
`computers performing the equivalent of single database.
`And so why –
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`I mean, based on what we've done already in
`the other cases, why should we not find that Korfhage
`simply discloses a known alternative to implement a
`database? You can use a single computer, if that has
`sufficient processing capacity, or you can use a
`distributed database with multiple computers, if you
`needed added capacity, but still run it with a single query
`as if it were a single database.
`Why shouldn't we read Korfhage to disclose
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`that?
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`MR. BRIER: Again, because the Korfhage is
`describing a completely different system. It's not
`describing what we have in the '963 patent of one
`centralized database that maybe for evaluation purposes
`you may be able to read the data from multiple computers,
`but the control of the data, the entry of the data is all
`controlled by one single, centralized database.
`JUDGE BONILLA: Well, why would
`somebody think that you couldn't do it the way it's
`described in the Korfhage reference?
`MR. BRIER: Again, the Korfhage reference
`that's up on the screen here, this is page 276, which is
`relied upon by Petitioners, it's talking about a different
`system.
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`So if you look at the second paragraph of the
`page that refers to the three major problems that arise
`from distributed databases, it says, first is a virtual
`certainty that different databases will have different
`formats and different processing requirements.
`This isn't a centralized database that happens
`to be accessible at a distributed basis. These are all
`different databases spread out to however many places,
`where the data can be input or manipulated from multiple
`points. I mean, it's actually talking about having different
`formats and different processors talking to each other.
`I guess the way I think about it is if you have
`a region where there's a region of college libraries; so you
`have Georgetown, Maryland, say Loyola, they all have
`their own individual libraries. But maybe they are
`interconnected in that you can search for a book over all
`three libraries. But each individual library inputs and
`changes the data individually. That's what's defined in
`Korfhage.
`
`JUDGE BONILLA: It talks in the first
`problem though, doesn't it propose a solution to that
`problem?
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`MR. BRIER: The solution there isn't the
`solution of the control issue. That's the important issue in
`the ACA is the control issue. The solution here is just to
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`make sure that the systems can talk to each other. That's
`what Korfhage gets concerned about is whether these
`different systems can talk to each other. It doesn't
`concern this centralized database that we have the --
`JUDGE MURPHY: Well, wait a minute. I
`mean, in the immediately preceding paragraph, the last
`sentence of Korfhage says, quote, “In effect, the user
`would prefer to view the system as accessing a single
`logical database in response to a query, even when the
`system must consult multiple physical databases,” closed
`quote.
`
`So how is that different than what's being
`described and claimed in the '963 patent, in that -- you
`know, the limitation that's at issue here?
`MR. BRIER: Again, this is saying in one
`place you can look, and then you can access multiple
`places. So, again, to go back to the college library --
`JUDGE MURPHY: No. But why is it
`different? The question is --
`MR. BRIER: The reason it's different is
`because -- just to finish up the analogy, for the ACA, to
`us it's more of a Library of Congress. We have all that
`date under one place. One place controls input to the
`data, but other places can look in there and see what's
`available, but can't necessarily change the data.
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`This Korfhage is talking about how any of
`these individual places, locations, you can view all the
`data, but you don't control it. It's being input and
`changed at various access points. And it's just an opening
`up of a system that would be absolutely contrary to what's
`described in the ACA.
`If you look at Petitioner's -- on the petition,
`they tell us over and over again the necessity of having
`this single place where everything --
`JUDGE BONILLA: A single database, right?
`MR. BRIER: Pardon?
`JUDGE BONILLA: It's a single database? All
`the information is going into one place, right?
`MR. BRIER: Sure. This is from the opening
`petition. This is page 25.
`JUDGE BONILLA: Because there seems to be
`two different things, like the database that holds
`everything, and then the computers that give the
`information to the database, right?
`MR. BRIER: In the '963 patent, yes, it's one
`centralized database that controls all the information, but
`as far as the claims 24, 26 and 27 go --
`JUDGE BONILLA: I'm sorry to interrupt you.
`The claim reads: A central computer database, meaning
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`one database, being distributed over multiple computers.
`But that's still a single database, right?
`MR. BRIER: It's a single database, correct.
`Korfhage isn't that. Korfhage is multiple databases that
`can be viewed from a single location, but it's still multiple
`databases that are all subject to change. And the claims
`on that aren't distributed in databases.
`JUDGE MURPHY: Taking your view then,
`right, so you have a single logical database in Korfhage,
`but potential access for multiple computers, right, or
`multiple locations? It's not -- you're saying it's not
`controlled at a single source?
`MR. BRIER: I'm saying what Korfhage is
`saying is that from a single place, you can look at all
`these databases, you can review their contents, but you
`don't have that control that you have in the '963 patent
`and the control that is stressed over and over again in the
`ACA. That are from a single logical point you can review
`all of the information from various disparate databases,
`but you don't have the control over those disparate
`databases. That data can be manipulated at various
`points.
`
`And that's the problem that the ACA was
`seeking to prevent, was having this data manipulation at
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`various points of entry. They only wanted one point of
`entry.
`
`JUDGE MURPHY: Right. But, I mean, the
`response to that is the ACA discloses use of a single
`database. And the Petitioner's argument is we've always
`understood it as -- they are only taking the teaching of
`Korfhage, that rather than have a single computer database
`in a single location, if you need greater capacity, you can
`expand it to a distributed database. You are still
`maintaining the control over the database that the ACA
`discloses.
`
`MR. BRIER: Sure. We dispute that that's
`what Korfhage says, though. Korfhage says multiple
`databases talking to each other viewed from a single
`location. Plus, there was no teaching or motivation here
`that you would need this excess capacity.
`And the drug here is a treatment for
`narcolepsy. There's a very small patient population for
`that drug. So there's been no showing in the record here
`that you need this expanded capacity.
`And, again, not to belabor the point, but this is
`Petitioner's own petition where they stress the importance
`of a single computer database to achieve the benefits
`described by the ACA, e.g., efficient and immediate
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`analysis of potential abuse situations from one efficient
`and quickly accessible location.
`Again, this is stressing over and over again in
`the ACA that you need to have this all in one location so
`you can evaluate this information in real time. So you
`know immediately if someone's tampering with the
`inventory, if someone's seeking multiple prescriptions
`from doctors.
`And if you have that disparate database and
`you have to check several databases to figure that out,
`that's contrary to the purposes of the ACA.
`And here, Petitioner's expert, when he -- Dr.
`Valuck, when he was looking for a reason to combine
`these references, he generally argued in favor of
`efficiency.
`But,as I said before, there was no teaching in
`the art that that was necessary to seek out these multiple
`databases. And in their efficiency argument actually runs
`contrary to what they said in their petition about the ACA,
`where they said the ACA achieves efficient immediate
`analysis of potential abuse situations.
`And they make this point a couple times over
`in their petition. It's also on page 35 to 36 of the opening
`petition where they say, The benefits of this program are
`not only the products distributed from a central location,
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`but all controls and all records are in one place, i.e.,
`central data repository, single location.
`They make the point again on 45, in the
`opening petition, that the benefit of using a single
`specialty pharmacy for distribution of Xyrem is that it's
`possible to keep all the data about inventory in one
`efficient accessible location, i.e., a single computer
`database.
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`So they're saying over and over again that the
`efficient way to run the system is to keep everything --
`based on the ACA, their primary reference, which Jazz
`developed, describes Jazz's system at the time for
`distributing Xyrem.
`But that stresses over and over again that it's
`efficient to keep everything housed in one place.
`No mention there of any concerns about having
`an abundance of data that you couldn't house in one
`processor. And their argument that Korfhage could make
`that system more efficient just runs counter to their
`reliance on the ACA.
`Also, even if there was motivation – and we
`dispute that there was motivation here -- there's no reason
`in the prior art that would have directed you to page 276
`of this 300- plus page reference.
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`JUDGE MURPHY: That's not a legal
`requirement. I mean, it's an example of a distributed
`database. Their argument is, hey, the ACA tells you, you
`want a single controlled system, and you need a single
`controlled system.
`MR. BRIER: Yes.
`JUDGE MURPHY: And the argument is, it
`was known that if you needed extra capacity and wanted
`extra capacity, wanted better efficiency, wanted lower
`cost, you had a known alternative to use multiple
`compu
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