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`IPR2015-00545 Paper No. 68
`IPR2015-00546 Paper No. 69
`IPR2015-00547 Paper No. 69
`IPR2015-00548 Paper No. 68
`IPR2015-00551 Paper No. 69
` IPR2015-00554 Paper No. 67
`May 18, 2016
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`AMNEAL PHARMACEUTICALS, LLC, PAR
`PHARMACEUTICAL, INC., AND WOCKHARDT BIO AG,
`Petitioner,
`
`v.
`
`JAZZ PHARMACEUTICALS, INC.,
`Patent Owner.
`____________
`
`IPR2015-00545 (Patent 8,589,182 B1)
`IPR2015-00546 (Patent 7,765,106 B2)
`IPR2015-00547 (Patent 7,765,107 B2)
`IPR2015-00548 (Patent 7,895,059 B2)
`IPR2015-00551 (Patent 8,547,988 B1)
` IPR2015-00554 (Patent 7,668,730 B2)
`____________
`
`Held: April 19, 2016
`____________
`
`
`BEFORE: JACQUELINE WRIGHT BONILLA, BRIAN P.
`MURPHY, and JON B. TORNQUIST, Administrative Patent
`Judges.
`
`The above-entitled matter came on for hearing on Tuesday, April
`19, 2016, commencing at 9:02 a.m., at the U.S. Patent and
`Trademark Office, 600 Dulany Street, Alexandria, Virginia.
`
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`Case IPR2015-00545
`Patent 8,589,182 B1
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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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`RICHARD J. BERMAN, ESQUIRE
`JANINE CARLAN, ESQUIRE
`BRADFORD C. FRESE, ESQUIRE
`Arent Fox, LLP
`1717 K Street, N.W.
`Washington, D.C. 20036
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`F. DOMINIC CERRITO, ESQUIRE
`EVANGELINE SHIH, ESQUIRE
`FRANK C. CALVOSA, ESQUIRE
`ERIC STOPS, ESQUIRE
`GABE BRIER, ESQUIRE
`Quinn, Emanuel, Urquhart & Sullivan, LLP
`51 Madison Avenue, 22nd Floor
`New York, New York 10010
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`Case IPR2015-00545
`Patent 8,589,182 B1
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`P R O C E E D I N G S
`- - - - -
`JUDGE MURPHY: Good morning, everyone. Nice to
`see a full house today. All right. We are here to hear oral
`arguments in a series of related cases. We have IPR2015-545,
`546, 547, 548, 551 and 554. The cases involve Par
`Pharmaceutical, Amneal Pharmaceuticals and Wockhardt versus
`Jazz. We also have additional related cases that have been joined.
`All right. We have six patents at issue, six cases, but
`there are significant overlapping issues. The Board appreciates
`counsel trying to simplify that for us. So we understand you'll be
`arguing from IPR2015-00548, Mr. Berman; is that right?
`MR. BERMAN: If that's the '059 patent, Your Honor,
`that's right.
`MR. CERRITO: It is, Your Honor.
`JUDGE MURPHY: So please introduce yourselves,
`beginning with counsel for petitioner.
`MR. BERMAN: Thank you. Richard Berman on
`behalf of Par Pharmaceutical, Inc. With me is Janine Carlan and
`Bradford Frese, along with a representative of Par
`Pharmaceutical, Ms. Gina Gencarelli. For Amneal
`Pharmaceuticals, LLC, there's Steve Maddox and Matthew Ruedy
`and representatives from Amneal, Kenneth Cappel and Vikhyat
`Kaushal.
`JUDGE MURPHY: Welcome everyone.
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`MR. CERRITO: Good morning, Your Honors. Francis
`Cerrito from Quinn Emanuel on behalf of Jazz. With me today is
`Frank Calvosa, Eric Stops, Evangeline Shih and Gabe Brier. We
`also have a corporate representative from Jazz, Jana Gold, with
`us.
`
`JUDGE MURPHY: Welcome everyone. And thanks
`for arriving a little bit early. We are a little bit earlier than usual,
`but we do appreciate it because we have longer arguments today.
`So according to our hearing order, each side has
`90 minutes. Mr. Berman, are petitioners going to split the
`argument in any way or are you going to be presenting? How do
`you want to work that?
`MR. BERMAN: I will be presenting all of it, Your
`Honor. And I'll be using 30 minutes for my initial presentation
`and 60 minutes for rebuttal.
`JUDGE MURPHY: Okay. So we have you on the
`clock here, Mr. Berman. If you run over, that's fine. You'll just
`reduce your rebuttal time. Mr. Cerrito, you'll have 90 minutes, no
`rebuttal time.
`I remind everyone that petitioners bear the ultimate
`burden of proof based on the preponderance of the evidence of
`their assertions upon patentability. I also remind the parties that
`this is a public hearing. We will have a transcript. We have a
`reporter up front. So please be mindful of that in terms of citing
`exhibits in the demonstratives. And if you are quoting from the
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`patent or other evidence, just take your time so we can get it all
`down and keep a clear record.
`If there are no questions, Mr. Berman, please begin.
`MR. BERMAN: Thank you, Your Honor. Good
`morning, Your Honors. Your Honors, here the patentees told the
`public about their restricted drug distribution system for Xyrem
`then tried to patent it a year and a half later, but you can't do that
`under U.S. law. The documents disclosed to the public,
`Exhibits 1003 through 1006, known collectively as the Advisory
`Committee Art or the ACA, render the six patents at issue here
`obvious.
`Today I will be focusing on the following topics: The
`public availability of the ACA, claim construction and
`obviousness.
`First the public availability issue. Jazz argues the
`petitioners have failed to prove the materials provided to the
`advisory committee, Exhibits 1003 through 1006, were publicly
`available prior to the critical date of December 17, 2001. Now, it
`is true that petitioners do not have eyewitness testimony that
`these briefing materials were posted on the FDA's website by the
`June 6, 2001, Xyrem advisory committee meeting. But it's well
`settled that that's not necessary. Here the totality of the evidence,
`which is the standard, easily shows that it's more likely than not
`that the briefing materials were posted in advance of the meeting.
`So let's go through this evidence.
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`JUDGE MURPHY: Mr. Berman, let me stop you there
`for a moment. Are you in agreement, then, that there's no direct
`evidence of the links as of the date of the Internet archive exhibits
`that have been submitted?
`MR. BERMAN: I don't know which -- there are several
`links at issue here. It is undisputed that Exhibit 1003 had active
`links and was publicly available prior to the critical date. The
`dispute is surrounding Exhibits 1004 through 1006. So that's the
`evidence I'm going to focus on.
`JUDGE MURPHY: Okay.
`MR. BERMAN: So first you have the Federal Register
`Notice, Exhibit 1015, the FDA said in this Federal Register
`Notice that it was going to post the briefing materials on its
`website 24 hours before the meeting. And following the links in
`the Federal Register Notice you end up on this page,
`Exhibit 1019. And there's a couple of items I wanted to point out
`on this exhibit.
`First, it is undisputed that this document, the FDA's
`website with the links, was publicly available no later than July 1,
`2001. That's less than a month after the advisory committee
`meeting and five months prior to the critical date. Second, it's
`undisputed that clicking on these links sends you to the briefing
`materials through this very day. But Jazz argues just because the
`links send you to the briefing materials today doesn't mean they
`sent you there prior to the critical date. The links could have
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`been dead or sent you to something else. But there is no evidence
`that the links were dead or that they sent you to something else.
`JUDGE BONILLA: Is there any evidence that you
`could have come up with to show that back in the day they would
`have, in fact, worked?
`MR. BERMAN: Well, that gets to the Internet archive
`evidence a bit. We do have certain Internet archive evidence that
`shows certain of these materials that I'm going to go through were
`absolutely available no later than the certain capture date. The
`exhibits in dispute, 1004 through 1006, unfortunately, due to the
`luck of the draw with regard to the web crawler, as Mr. Butler
`says in his declarations, due to the luck of the draw, there were
`not captures of those materials prior to the critical date. And
`those are the materials I'm going to focus on, the corroborating
`evidence, the substantial corroborating evidence that they were
`posted by the critical date.
`JUDGE BONILLA: Was that a product of the
`Wayback Machine or is there something to the fact that you
`couldn't come up with that evidence?
`MR. BERMAN: Well, that's really the only feasible
`way of determining what happened 15 years ago, Your Honor.
`So like I said, we do not have eyewitness testimony that says
`these were put up. We do have substantial corroborating
`evidence that I want to go through.
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`JUDGE MURPHY: Mr. Berman, before you do that,
`on Exhibit 1019, the different links, can you relate those to
`Exhibits 1004 through 1006?
`MR. BERMAN: Sure. So this briefing information
`link is Exhibit 1005. The Xyrem prescription and distribution
`process video script, these links and the video links, that's
`Exhibit 1006. And the safety review is the FDA review, and that
`is 1004. So those are the links that I'll be discussing.
`JUDGE MURPHY: Thank you.
`MR. BERMAN: So going back to the substantial
`corroborating evidence, there is substantial corroborating
`evidence that the FDA did post these materials just like they said
`they were going to do. First and foremost, we have the FACA,
`the Federal Advisory Committee Act. Now, it's undisputed that
`the Exhibit 1015 says that the advisory committee meeting is
`being held under the FACA. And under the FACA, materials that
`are provided to an advisory committee like this one must be made
`available to the public. And the FDA's guidance regarding the
`FACA explicitly requires that these materials be made available
`to the public, quote, before or at the time of the advisory
`committee meeting. So when the FDA said in the Federal
`Register Notice it was going to post the Xyrem briefing materials
`before the advisory committee meeting, it was following its
`standard protocol.
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`Jazz presents no evidence that the FDA failed to comply
`with the FACA or failed to follow its own rules in its guidance.
`So there is no basis to conclude the FDA did not do exactly what
`it said it was going to do and post the Xyrem briefing materials in
`accordance with the FACA, the law, and its own rules, its
`guidance.
`So what other corroborating evidence do we have?
`Again, first and foremost, we have Jazz's predecessor, Orphan
`Medical, the patentees here telling FDA, telling FDA that its
`briefing material, Exhibit 1005, was available for public
`disclosure without redaction. And according to FDA's guidance,
`that's Exhibit 1057 at page 4, that's exactly the way you are
`supposed to label materials that are going to be made available
`before an advisory committee meeting.
`We also have the redactions in the FDA's safety review,
`Exhibit 1004. Again, according to FDA's guidance, that's exactly
`the way FDA's documents should be posted. And then back to
`Exhibit 1019, we have this disclaimer followed by a lot of
`verbiage here. This exact language of a disclaimer is mandated in
`the FDA guidance. That's Exhibit 1057 at page 6. So all of this
`evidence corroborates that the FDA posted these materials just
`like it said it was going to do.
`Finally, there's the meeting transcript, Exhibit 1003,
`which as I said, is undisputed prior art. The meeting transcript
`contains several references to the briefing materials, and I want to
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`go through those. Here is Exhibit 1003 at page 12. Dr. Katz
`from the FDA says, As you know from the briefing documents,
`and goes on to talk about them.
`JUDGE MURPHY: Mr. Berman, in Exhibit 1003, are
`there any more particular references to the individual documents
`themselves or is it more in the nature of briefing materials
`generally?
`MR. BERMAN: It's more in the nature of briefing
`materials generally. And if I could finish going through them,
`you'll see the specifics of how they describe them.
`Next is page 284 from a Dr. Chervin. And what's
`important with Dr. Chervin is he was actually phoning into the
`meeting. So he was not present on the day. And Dr. Chervin
`says, I read in some of the material that was distributed prior to
`the meeting, and he goes on to talk about the materials.
`Then there's page 330, Dr. Leaderman. Dr. Leaderman
`says, Let me refer you to a table. It is actually the last page in
`your blue FDA briefing package book.
`And finally, we have from Dr. Falkowski, he has says,
`If you look at the third page from the back of the materials the
`FDA provided, and then he goes on to talk about certain items in
`those materials.
`JUDGE BONILLA: Is there anything in Exhibit 1003
`that indicates that that briefing material are the three things that
`we are talking about?
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`MR. BERMAN: So here is the issue with that. There is
`absolutely no evidence of there being any other briefing materials
`other than what's on Exhibit 1019. There is no evidence
`whatsoever. So when they are talking about briefing materials
`and in Exhibit 1019 there are the briefing materials, that's the
`universe of documents. There is no evidence whatsoever of there
`being any other documents or any other versions of those
`documents. So that is the universe. So when they are talking
`about briefing materials in Exhibit 1003, that is the only briefing
`materials there is to talk about.
`JUDGE BONILLA: Is it possible it's referring to
`briefing information only, which would be Exhibit 1005 and not
`the others?
`MR. BERMAN: The FDA materials, 1005?
`JUDGE BONILLA: Right. When it talks about the
`briefing material and then you look on Exhibit 1019, there's
`briefing information. Is it possible it's only referring to the
`briefing information, Exhibit 1005, and not necessarily 1006 and
`1004?
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`MR. BERMAN: Actually, if anything, Your Honor,
`they are talking about the FDA briefing information, if anything.
`Certainly that's exactly what --
`JUDGE MURPHY: Well, the FDA briefing
`information, that's the preliminary clinical safety report which
`you are saying is Exhibit 1004, right?
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`MR. BERMAN: Correct. It's one of those materials.
`There are -- as you see in Exhibit 1019, there are several links to
`several different materials that the FDA provided. The one that
`we are talking about is the safety review because that one
`specifically discusses the Xyrem restricted drug distribution
`system. However, all of these materials were part of the FDA
`briefing information.
`So we have further corroborating evidence in our reply
`on pages 4 through 7, and I'll simply refer the Board to that. So
`here the totality of the evidence easily shows that it is more likely
`than not that the briefing materials were posted in advance of the
`meeting just like the FDA said they were going to do.
`Now, it's worth pointing out which links Jazz does not
`assert are broken or sent you to something else. So I think this
`will help address some of the comments that you had, Your
`Honors. So first this is Exhibit 1020, and this predates the critical
`date. And this printout contains a list of all of the materials the
`FDA posted for the Xyrem advisory committee meeting. Here
`are the links to the transcript which are pages 1 through 381 of
`Exhibit 1003. Jazz does not argue that these links didn't work.
`All of these links, they didn't argue that they don't work.
`Further, this is the next page of the exhibit, I refer you
`up here, the slides, these are Orphan Medical's slides that they
`presented at the meeting. They are pages 381 through 400 of
`Exhibit 1003. So Jazz doesn't argue that these links didn't work
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`or sent you to something else. And finally, we have the briefing
`information link itself. This is the link to Exhibit 1019. And Jazz
`doesn't say that this doesn't work or sent you to something else.
`JUDGE MURPHY: So that link at the top page of
`Exhibit 1020, you are saying that's a link to Exhibit 1019?
`MR. BERMAN: Correct. That's undisputed.
`JUDGE MURPHY: And then you have to go to the
`links in 1019 to get to the individual documents?
`MR. BERMAN: Correct. But it's undisputed that once
`you were directed to the links, you could easily scroll through.
`That's not what's in dispute here.
`So the totality of the evidence shows that the ACA was
`available prior to the critical date. The ACA was also locatable
`by persons interested and ordinarily skilled in the subject matter
`in the patents. For analyzing locatability, being a person of
`ordinary skill in the art, what we have been calling a POSA, is
`only half the standard. There's an additional requirement that the
`person be interested in the subject matter of the patents. And
`further, the interested POSA must merely be capable of locating
`the prior art. There is no requirement, despite Jazz's protestations
`otherwise, that a POSA had actually located the prior art. An
`example citation for that is IPR2014-00059, paper 9 at 34 to 35.
`We cite that in our petition.
`Jazz's first argument that a POSA would not have
`bothered looking for the ACA ignores this additional requirement
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`of interest in the subject matter. Simply put, a POSA interested
`in restricted drug distribution systems would have been motivated
`to look for materials relevant to restricted drug distribution
`systems. As petitioners' declarant, Dr. Valuck, put it, a POSA
`here wants to keep track of what FDA and other agencies in the
`world of drug distribution are doing. So an interested POSA here
`could have found the relevant materials like the Federal Register
`Notice and the ACA.
`Jazz's second argument against locatability is that a
`POSA would have never known the ACA existed because a
`POSA would not have actually found the Federal Register Notice
`of the advisory committee meeting. But Jazz is wrong both
`legally and factually. Legally the notices published in the Federal
`Register are deemed to provide adequate notice to interested
`persons. These include persons having a legal interest as well as
`those having a scientific or technical interest. So by law, persons
`interested in the subject matter of the patents had adequate notice
`of the advisory committee meeting and therefore, were capable of
`locating the ACA, which again, is the test for locatability.
`But even putting that law aside, there is no credible
`basis for Jazz to assert that a POSA would not have been able to
`find the Federal Register Notice here. As indicated in the
`meeting minutes, Exhibit 1003, and I'm on page 3 here, 15
`members of the public spoke at the Xyrem advisory committee
`meeting. They are listed here. So in fact, interested persons were
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`not only capable of finding the notice, they did find the notice.
`So there's no credible basis to conclude that a POSA was
`incapable of finding the notice. The totality of the evidence
`shows that the ACA was available and locatable prior to the
`critical date.
`So I would like to turn now to claim construction.
`There are three terms that Jazz unduly seeks to narrow. First I
`want to just discuss the generating periodic report step. To put
`the claim in context here, this is the '059 patent and here is the
`generating step. Generating with the computer processor periodic
`reports via the exclusive computer database to evaluate potential
`diversion patterns. So viewed in context, the generating periodic
`reports step is used to evaluate potential diversion patterns.
`Several types of reports are described in the patents.
`You have figures 13A through C which describe reports run at
`certain intervals such as weekly, monthly or quarterly. And
`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 4B, any of those reports can
`potentially identify diversion patterns, which is the context of the
`claim.
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`But Jazz argues otherwise. Based primarily on extrinsic
`evidence, a dictionary definition of the word "periodic" Jazz
`seeks to narrow the generating periodic reports step to the types
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`of reports described in Figures 13A through C but not the types of
`reports described in Figure 4B. But Jazz's extrinsic evidence
`cannot trump the applicant's own statement that Figure 4B
`describes periodic reports to evaluate potential diversions of the
`drug. And that's in Exhibit 1047, the appeal brief in the '730
`patent.
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`JUDGE MURPHY: How does that address -- their
`point, as I understand it, is these reports have to be on some
`regular basis, weekly, monthly, whatever it might be. So where
`in the intrinsic evidence -- let's set aside the extrinsic evidence for
`the moment. Where in the intrinsic evidence in the spec with the
`description of 4B, for example, does the patent indicate
`something other than a regular, periodic, preset generated report?
`MR. BERMAN: Well, there's no definite -- periodic is
`not defined. It doesn't even appear in the patent, in the spec. It's
`not defined. So you have to go by what is the point of this claim.
`The point of this claim is to evaluate potential diversion patterns.
`That is evaluated by generating periodic reports, reports either on
`an ad hoc basis, periodically every now and again, intermittently.
`Those are all valid definitions of what periodic means. We've
`submitted three definitions in our reply that say just that. Or --
`and it also means generated at regular frequencies. It means both.
`Periodic means both. It means intermittent and it also means
`generated regularly.
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`So there is no indication at all of two very important
`things, one, that periodic, when the applicants use the term
`"periodic," they intended to exclude intermittent from the
`universe; and second, there is absolutely no evidence, in fact,
`there's contra evidence that applicants intended to exclude
`Figure 4B, the types of risk diversion reports, that are generated
`there from the scope of the claims. There is no evidence of that.
`JUDGE BONILLA: Are the reports in 4B, are they
`intermittent as opposed to regular?
`MR. BERMAN: They could be intermittent in that they
`are generated in response to an early refill request. So you can
`look at them as saying, well, that's on an ad hoc basis. Every time
`there's an early refill request, there is a report generated about it.
`But you can also look at that and say that that is periodic because
`every time there is an early refill request, you are generating a
`report. So that happens every time. So since it happens every
`time, it happens regularly. So there's, again, no basis to conclude
`at all in any of the intrinsic evidence that the applicants intended
`to exclude Figure 4B and the types of reports there. And in fact,
`again, getting back to the claim, those types of reports in
`Figure 4B evaluate potential diversion patterns, exactly what the
`claim requires.
`Jazz also seeks to narrow the information identifying
`patients and medical doctors' terms, which I'll discuss together.
`Now, neither the petitioners nor the Board identified those terms
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`as requiring construction. Instead, in accordance with PTAB
`rules, the terms should be accorded their plain and ordinary
`meaning and given their broadest reasonable interpretation in
`light of the specification.
`Jazz, however, seeks to narrow these terms based on
`one embodiment, Figure 9. But there is, again, no evidence
`whatsoever in the intrinsic evidence that the applicants intended
`to limit the scope of the claims to Figure 9. There is no evidence
`whatsoever. Therefore, the Board should not further limit these
`claim terms.
`Finally, I would like to turn to obviousness. Jazz has
`already conceded most of the limitations in the claims are
`obvious over the ACA. Only a few limitations are in dispute.
`Let's start with the generating periodic reports step. Now, Jazz
`admits that the ACA discloses the types of reports described in
`Figure 4B. So if the Board declines to narrow the scope of the
`claims to the reports, only the reports described in Figures 13A
`through C, as it should, Jazz concedes on this point.
`But even if the Board accepts Jazz's faulty construction
`and limits the scope of the claims unduly to Figures 13A through
`C, this limitation is still obvious over the ACA. First, Jazz's
`declarant, Dr. Bergeron, conceded that querying the central data
`repository was one way to obtain data for the reports in the ACA.
`Dr. Bergeron also conceded that the ACA discloses identifying
`potential diversion patterns, again, the scope of the claim, prior to
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`filling a prescription. Not just after an investigation has begun.
`So again, talking about periodic, if every time you are looking
`and generating a report prior to filling a prescription, that could
`be as periodic as anything. So even if the Board accepts Jazz's
`erroneous claim construction, the generating periodic report step
`is still obvious over the ACA.
`Finally, I want to address the prescription request
`limitation. And here is an example in the '059 patent of this
`claim. It says the prescription request containing information
`identifying patients, the prescription drug and various credentials
`of any and all medical doctors.
`So first just to put this into context, we are talking about
`a prescription form here and the obviousness of putting such
`basic information as the patient's name, Social Security number,
`date of birth, sex and address on that form, that's what we are
`talking about here.
`Jazz concedes that the prescription requests contain
`some information identifying the patient and the prescriber. Jazz
`also concedes that all of the information that Jazz asserts is
`required under the claims is disclosed in several places in the
`ACA. But they argue, since not all of this information is on the
`form itself, the claims are not obvious.
`But even if Jazz is correct, and they are not, but even if
`they are, Jazz does not explain why a POSA, a person of ordinary
`creativity under KSR, would not have found it obvious to put
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`information from several forms onto one form. And to reiterate,
`we are talking about putting basic information onto a form.
`For the other claim terms, petitioners rest on their briefs
`and I'll reserve the remainder of my time for rebuttal.
`JUDGE BONILLA: So your position is that patent
`owner concedes that all of the information is on forms of some
`kind in the art but that they are not all in the same form? That's
`their position?
`MR. BERMAN: Their position is that all of the
`information is disclosed as being available in the ACA --
`JUDGE BONILLA: Just not in one place?
`MR. BERMAN: -- through various means. It's just not
`all sitting on that form.
`JUDGE MURPHY: Thank you, Mr. Berman.
`MR. CERRITO: Good morning, Your Honors, may it
`please the Court. Let me pick up on that very last point we just
`heard. All the information is available elsewhere in different
`forms. If you look at the ACA, what it tells you to do in certain
`instances is have discussions with doctors. Pick up the telephone
`and talk about to them. Why? Because they were worried. They
`were concerned that doctors may fake their numbers, might fake
`the prescriptions, as we see with the way things are going on
`now. Unfortunately, some prescriptions are going out the back
`door. So there was an interaction that took place through phone
`calls, through other surveys, DEA inquiries. They didn't all exist
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`in one place on a prescription form. So Mr. Berman, I think,
`overstates his case by a long shot.
`I'm going to break a little bit with my intended script
`here only because I have heard so many things this morning that
`are simply not accurate. You know, the first and foremost, I'm
`concerned that -- and I'm not concerned the Board is going to
`miss this, but the burden of proof here is on petitioners. Not on
`Jazz. Jazz doesn't need to show anything. And we've been
`blamed repeatedly that we didn't show this, we didn't show that.
`We don't have to show anything. What we did point out is the
`evidence that has been presented to this Board is not good
`enough.
`And let's take a step back for one second. Just because
`you throw a lot of things at the wall hoping something will stick
`doesn't make any of them any good. It's a lot of incomplete
`conjecture, speculation about what would have, what must have
`existed. Just because you say a lot of things doesn't make the
`totality of circumstances --
`JUDGE MURPHY: Isn't their position that there are
`various pieces of circumstantial evidence that all point in the
`same direction, and if it points in the same direction, we should
`infer the conclusion from that evidence?
`MR. CERRITO: It points in a speculation direction.
`That's the problem. So to use a bad analogy, if I have a little pile
`of garbage, it's not somehow better than a big pile of garbage.
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`JUDGE BONILLA: But you can understand the
`position as saying we have this piece of circumstantial evidence,
`and this and this and this, and there is nothing to the contrary?
`MR. CERRITO: I'm sorry?
`JUDGE BONILLA: They have multiple pieces of
`circumstantial evidence to say that it was publicly accessible and
`there's nothing to the contrary.
`MR. CERRITO: No, Your Honor, I don't agree with
`that. What I agree with is that they have a bunch of innuendos,
`speculation about what must have occurred. Let's start from the
`point that this Board has already held, something about the
`Federal Register in The Coalition For Affordable Drugs versus
`Jazz. The Federal Register at issue here, this very issue, this
`same Federal Register Notice does not show that the ACA
`actually was