`Trials@uspto.gov
`571-272-7822
`
`Paper 28
`Entered: November 12, 2021
`
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`___________
`
`SLAYBACK PHARMA, LLC,
`
`Petitioner,
`
`v.
`
`SUMITOMO DAINIPPON PHARMA CO. LTD.,
`Patent Owner.
`___________
`
`IPR 2020-01053
`Patent 9,815,827 B2
`___________
`
`
`Record of Oral Hearing
`Held: August 11, 2021
`_____________
`
`
`
`
`Before SUSAN L. C. MITCHELL, ZHENYU YANG, and
`KRISTI L. R. SAWERT, Administrative Patent Judges.
`
`
`
`
`
`
`
`
`
`

`

`IPR 2020-01053
`Patent 9,815,827 B2
`
`
`APPEARANCES:
`
`ON BEHALF OF THE PETITIONER:
`
`
`
`LOUIS H. WEINSTEIN, ESQUIRE
`
`Windels, Marx, Lane & Mittendorf, LLP
`
`One Giralda Farms
`
`Madison, NJ 07940
`
`
`ON BEHALF OF PATENT OWNER:
`
`
`
`
`
`
`
`
`
`CHAD SHEAR, ESQUIRE
`Fish & Richardson, PC
`12860 El Camino Real
`#400
`San Diego, CA 92130
`
`
`
`The above-entitled matter came on for hearing on Wednesday,
`August 11, 2021, commencing at 1:00 p.m., EDT, at the U.S. Patent and
`Trademark Office, by video/by telephone, before Walter Murphy, Notary
`Public.
`
`
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`2
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`IPR 2020-01053
`Patent 9,815,827 B2
`
`P R O C E E D I N G S
`- - - - -
`JUDGE YANG: Good afternoon. This is a hearing for IPR 2020-
`
`01053. The challenged patent is 9,815,827. I am Judge Yang. Judges
`Mitchell and Sawert are also on the panel. Now counsel, please introduce
`yourselves. Let's start with Petitioner.
`
`MR. WEINSTEIN: I am Louis Weinstein, Your Honor, from the law
`firm of Windels, Marx, Lane & Mittendorf. I represent Petitioner Slayback
`Pharma, LLC.
`
`JUDGE YANG: Welcome. Patent Owner.
`
`MR. SHEAR: Good afternoon everyone. My name is Chad Shear.
`I'm am attorney with Fish & Richardson and I represent Sumitomo
`Dainippon Pharma, SDP for short, the Patent Owner.
`
`JUDGE YANG: Thank you and welcome everyone. Before we start
`the oral argument we will quickly go through a couple of housekeeping
`items. For today's hearing each party has 60 minutes to present its
`arguments starting with Petitioner, followed by Patent Owner. Both parties
`may, if you desire, reserve time for rebuttal. During your argument please
`clearly identify the record so the transcript is clear and so we can follow you
`because we are conducting this hearing remotely, we cannot see what you
`put on but we have the record including your demonstratives so if you
`identify what you are referring to clearly we'll be able to follow you.
`
`For today's hearing, if you have any objection please do not interrupt
`the other side. Instead, if you could just hold it until the other side has
`finished the argument, that would be great. A very important point, please
`mute yourself and only unmute when you are talking. You also should have
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`IPR 2020-01053
`Patent 9,815,827 B2
`contact number for the Board if you encounter any technical difficulties,
`please let us know ASAP. Lastly, after we're finished the oral argument the
`parties please stay on the line even though the panel will sign off, please stay
`on the line to help the court reporter with any spellings or any clarification,
`that sort of thing. Are there any questions? Okay. I take that silence as no.
`So then now Petitioner, would you like to reserve any time for rebuttal?
`
`MR. WEINSTEIN: Yes, Your Honor. Petitioner would like to please
`reserve up to half its time for rebuttal.
`
`JUDGE YANG: All right. That means you have 30 minutes now. I
`will keep time here on my phone. If you could try to keep time that would
`be great. All right. You may begin whenever you're ready.
`
`MR. WEINSTEIN: If it please the Board, as the papers show -- well,
`let me introduce myself for the record. I'm Louis Weinstein from the law
`firm Windels, Marx, Lane & Mittendorf. I represent Petitioner Slayback
`Pharma, LLC.
`
`As the papers show Petitioner asserts three grounds. Grounds 1 and 2
`are directed to the manic depressive claims and hinge on written description
`in the '927 provisional. Ground 3 is that all claims are obvious. Petitioner
`would like to start with several points on grounds 1 and 2 and then move on
`to ground 3.
`
`For its first point, Petitioner would like to direct the Board to page 4
`of Petitioner's demonstrative exhibits, that's Exhibit 1057 and that's page 4.
`This page summarizes the elements of claim 8. Claim 8 is illustrative of the
`manic depressive claims. But even for claim 8 Patent Owner never went
`through the process of showing how the '927 provisional described the
`method with all these limitations. In fact, if Patent Owner had tried it would
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`IPR 2020-01053
`Patent 9,815,827 B2
`have been very messy. This is because, if you look at Lurasidone and its salt
`is never mentioned in the context of manic depressive psychosis. Nowhere
`in the '927 provisional is Lurasidone mentioned in that context. Also 20 to
`120 milligrams per day is never explicitly recited as arranged in the '927
`provisional and the phrase "no clinically significant weight gain" is not
`explicitly recited. So it would have been very messy if they had tried to go
`element by element for illustrative claim 8 and perhaps that's why they did
`not do it.
`
`Now Petitioner pointed out that Patent Owner, you know, had failed
`to do this and Patent Owner's response is at the bottom of page 3. That
`would be Petitioner demonstrative exhibit page 3 and if you look at the
`bottom, Patent Owner said in its surreply,
`
`"It goes without saying that 'the claimed Lurasidone dosing regimen'
`means 'the claimed method with all limitations.'"
`
`Your Honors, Petitioner submits that saying it goes without saying is
`not good enough. It was Patent Owner's burden to show written description
`of a method with all the limitations of the manic depressive claims and
`Patent Owner did not.
`
`Petitioner would now like to go on to its next point and would like to
`say that the only mention of manic depressive psychosis in the '927
`provisional is a single passing reference in a complex field. Patent Owner
`admits that the field of anti-psychotic drugs is complex.
`
`If we could please turn to page 6 of Petitioner's demonstrative
`exhibits. This comes right out of the '927 provisional and it shows the single
`reference to manic depressive psychosis in the entirety of the '927
`provisional and Petitioner notes that this one mention is in the background
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`IPR 2020-01053
`Patent 9,815,827 B2
`section and in the context of a huge genus.
`
`For its next point, Your Honors, Petitioner wants to say that Patent
`Owner in the parent application argued that in the prior art Lurasidone was
`not associated with effective treatment of schizophrenia. So if we could all
`turn to page 6 of Petitioner's demonstrative exhibits, what happened was that
`there were claims directed to schizophrenia in the parent application and
`these were rejected over Saji EP '846, that's the counter-part to the Saji
`patent that's mentioned in the background section of the '927 provisional.
`Now, to overcome this rejection the Patent Owner argued, and I quote,
`
`"Nowhere in Saji EP '846 is the particular compound recited in the
`present claim 1 (Lurasidone) associated with effective treatment of
`schizophrenia."
`
`So Patent Owner was very happy to rely on there being no association
`between Lurasidone and schizophrenia when it suited it and Petitioner here
`maintains that nowhere in the '927 provisional is Lurasidone associated with
`the treatment of manic depressive psychosis. So this lack of association
`really hurts, in fact is perhaps fatal on the question of written description in
`the '927 provisional.
`
`JUDGE YANG: So counsel, I have a question. Surely you're aware
`that Patent Owner is arguing the overlapping symptoms between the
`schizophrenia and manic depressive psychosis. If I understood their
`arguments correctly I think they are saying because of these overlapping
`symptoms, when you treat the schizophrenia you're also treating the
`symptoms of manic depressive psychosis. Do you have a response to that?
`
`MR. WEINSTEIN: I do, Your Honor, and I think they say that on
`page -- let's see, page PDX117 of their exhibits and there they say treating
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`IPR 2020-01053
`Patent 9,815,827 B2
`schizophrenia is treating the manic phase of manic depressive psychosis.
`Well that's just not true, Your Honor. There may be an overlap but it's not
`completely overlap. Treating schizophrenia is not treating the manic phase
`of manic depressive psychosis. Now maybe there are some overlapping
`symptoms but schizophrenia and manic depressive psychosis or bipolar
`disorder are separate conditions in the DSM. So just by treating
`schizophrenia you're not treating manic depressive psychosis. It's sort of
`like rectangles and squares. Schizophrenia might be broader and there might
`be some overlap with manic depressive psychosis but it's not the same thing.
`You can treat part of schizophrenia and not treat manic depressive psychosis
`at all because they have not a complete overlap and in fact I don't recall
`anywhere in Patent Owner's papers where they say treating schizophrenia is
`treating manic depressive psychosis. They say there's an overlap but I don't
`recall them ever saying it's the same thing. Does that help, Your Honor?
`
`JUDGE YANG: Yes, thank so.
`
`JUDGE MITCHELL: Can I ask a quick question? This is Judge
`Mitchell. Why wouldn't an overlap be enough? You're still treating some of
`the symptoms of manic depression, why isn't that enough?
`
`MR. WEINSTEIN: Well, maybe you are and maybe you're not. If
`there's an incomplete overlap you could treat schizophrenia without treating
`manic depressive psychosis because not every drug treats every symptom of
`schizophrenia. So if there are, I don't know the exact number, seven
`symptoms of schizophrenia and seven of manic depressive psychosis and
`there's an overlap of two of them, you could treat five symptoms of
`schizophrenia without treating manic depressive psychosis. They are not the
`same thing.
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`IPR 2020-01053
`Patent 9,815,827 B2
`
`JUDGE MITCHELL: Thank you.
`
`MR. WEINSTEIN: It would sort of be like saying, I'm going to say in
`the context of metabolic disorder which can include kidney and liver and
`blood pressure, and high cholesterol and heart. Just because you're treating
`metabolic disorder it doesn't mean you're treating diabetes. You might be
`treating one of the other things and in the clinical trial it says that the
`patients who were tested in the clinical trial of the '927 provisional, they
`were all schizophrenia patients and it doesn't mention that any of them had
`been diagnosed with manic depressive psychosis and in fact there are
`separate approvals at the FDA. First, Lurasidone got approved for
`schizophrenia and then it got approved for only one part of manic depressive
`psychosis and it wasn't even the manic phase if I'm correct. It was the major
`depressive phase of bipolar disorder. May I continue?
`
`JUDGE MITCHELL: Sure.
`
`MR. WEINSTEIN: Petitioner's next point is that obviousness is not
`written description. If we turn to page 9 and now it's Patent Owner's, excuse
`me, and now it's Petitioner's exhibits, Exhibit 1057, page 9. We see what
`Ariad Pharm. Inc., v. Eli Lilly & Co. Inc., said about the difference between
`obviousness and written description and I don't have to go through that
`unless the Board wants but based on this Dr. Kosten's opinion that the claims
`of the '827 patent are obvious does not mean that the manic depressive
`claims have written description. Also Patent Owner never addressed Ariad
`in any of its papers as far as I could find.
`
`As Petitioner's final point with respect to the manic depressive claims,
`Petitioner wants to bring out that Patent Owner improperly relies on the
`Hybritech, Inc., v. Monoclonal Antibodies, Inc., case. If the Board could
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`IPR 2020-01053
`Patent 9,815,827 B2
`please turn to page 10 of Petitioner's demonstrative exhibits we can see what
`Patent Owner said. Patent Owner said,
`
`"The law does not require that a patent explicitly disclose information
`that would have been known to a POSA."
`
`But Hybritech was an enablement case and that was from 1986, long
`before Ariad when written description was still in question perhaps and
`Hybritech says nothing about written description. So before I go on to
`ground 3 does the Board have any questions about the overlap, any more
`questions about the overlap between schizophrenia and manic depressive
`psychosis?
`
`JUDGE YANG: Not from me.
`
`MR. WEINSTEIN: So the last thing I'm going to say on that is just
`because there's an overlap does not mean it's the same thing and in fact it
`doesn't mean that everything in manic depressive psychosis is included in
`schizophrenia. So it's not even rectangles and squares because all squares
`are rectangles but not all symptoms of manic depressive psychosis are
`schizophrenia and vice versa.
`
`Okay. Petitioner would now like to address ground 3. Ground 3 says
`all the claims are obvious. The first two grounds just deal with the manic
`depressive claims and ground 3 is that all the claims are obvious. If we
`could, could we please turn to page 14 of Petitioner's demonstrative exhibits
`and there we see that the Patent Owner has focused on average weight gain
`or the weight gain of a population, in fact they say rather the relevant
`question is how a population of patients will respond. But, Your Honors, all
`of the claims are directed to one or more patients. This is not a patent that
`deals with patient populations or on average. Some cases that were before
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`IPR 2020-01053
`Patent 9,815,827 B2
`the Federal Circuit really mattered whether it was a patient population or just
`one patient. But here it can be one or more patients which includes one
`patient and therefore a lack of weight gain in a patient population does not
`defeat the very strong evidence of obviousness. This is not a case of patient
`populations, the claims are all about one or more patients and that's not
`disputed by Patent Owner. Now if you could please turn to --
`
`JUDGE YANG: Counsel, on this point. Just so that I am clear --
`looking from your gesture are you having trouble hearing me?
`
`MR. WEINSTEIN: No, I just wanted to make sure that I could hear
`you.
`JUDGE YANG: Oh, okay. All right. I just wanted to make sure I
`
`understand your argument. You're saying that because the claim recites a
`patient or the patient and we did adopt your proposed construction that is a
`patient or the patient means one or more patients and because of that, you
`are saying as long as one patient does not gain, you know, experiences
`clinically significant weight gain then that limitation is satisfied. Do I
`understand that correctly?
`
`MR. WEINSTEIN: It would have to be one patient or more than one
`patient in order to satisfy. The point is that one patient would satisfy and it
`was expected that at least one patient would not gain weight. It's not a
`question that it had to be a drug where on average patients would not gain
`weight. It had to be a drug where at least one patient would not gain weight
`--
`JUDGE YANG: Okay.
`
`MR. WEINSTEIN: -- and if we go to page 12, excuse me, if we go to
`
`page 12 of Petitioner's exhibits we can see what Dr. Stahl, the Patent
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`IPR 2020-01053
`Patent 9,815,827 B2
`Owner's expert, said about weight gain and first Dr. Stahl said that
`Olanzapine, one of the prior art antipsychotics, was associated with weight
`gain big time. But when he was examined he admitted that in the prior art
`Olanzapine label he admitted that 71 percent of the Olanzapine patients did
`not gain a clinically significant amount of weight, only 29 percent gained.
`So of course it was expected that at least one patient would not gain weight.
`If 71 percent of the Olanzapine patients did not gain weight, and Olanzapine
`was associated big time, then of course it was to be expected that one or
`more patients would not gain weight with Lurasidone.
`
`JUDGE YANG: Okay. Counsel, let me stop you there. I want to sort
`of flesh this point out a little more. So there were two issues or two
`arguments in your petition. I think at first you said inherently, right, no
`clinically significant weight gain is inherent and then the same paragraph,
`the next sentence you said because of some structurally related drug that
`didn't -- when patients took that drug they didn't experience clinically
`significant weight gain thus the drug at issue here also wouldn't cause that. I
`just want to make sure, is it an inherency argument? Is it whether you would
`expect it or whether it's a combination? I'm not very clear on that issue.
`
`MR. WEINSTEIN: I think it's all of them, Your Honor. So the patent
`says one or more patients will not gain weight. The prior art Saji patent, as
`Dr. Stahl admitted, the preferred oral dose of the compound in that patent
`where Lurasidone was preferred was 5 to 100 milligrams per day. That is
`what is in the prior art patent and it is inherent that if you're going to give
`people 5 to 100 milligrams per day of Lurasidone, you're going to meet that
`limitation of no weight gain. That is the inherency part. Lurasidone is in the
`prior art. It is a preferred compound and the preferred range was 5 to 100
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`IPR 2020-01053
`Patent 9,815,827 B2
`milligrams. It is inherent in the prior art of not gaining weight. So that's the
`part of the inherency and if I could ask Your Honors to remind me please
`about the additional ones that Your Honor was asking about.
`
`JUDGE YANG: Well, then you go on to say it's expected that it is
`not -- the patients are not going to gain weight. Is this part of the inherency
`argument or a separate argument?
`
`MR. WEINSTEIN: That would be separate from inherency and there
`are good reasons why the POSA would expect at least one patient to not gain
`weight and that's because patients are different and at least of course one
`patient is not going to gain weight and in fact in Olanzapine which is the
`paradigm of big weight gain, only 29 percent gained weight, 71 percent did
`not. So the POSA would expect it and as I'm going to say in a future slide
`Horisawa also taught the POSA to expect no weight gain. Moreover, other
`compounds, other antipsychotics were not associated with weight gain and
`there was a structural similarity between Lurasidone and Ziprasidone and
`Ziprasidone was known to not gain weight. So it was expected that at least
`one would not gain weight.
`
`So on this slide I talked about how Dr. Stahl, he wasn't even aware
`about the weight -- about the range in weight gain outcomes and Dr. Stahl
`could not recall a study where more than half the Olanzapine patients gained
`a clinically significant amount of weight. So if half the patients aren't
`gaining weight of course it's expected that at least one patient will not gain
`weight and maybe now we would just skip, you know, because I want to
`make sure that there's time, we can skip to Horisawa -- if I can find it --
`okay. Horisawa is at page 15 of Exhibit 1057 Petitioner's demonstratives
`and in the petition Petitioner cited Horisawa Exhibit 1028 for its discussion
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`IPR 2020-01053
`Patent 9,815,827 B2
`of efficacy and side effects for a compound called SM-13496 and it was a
`dispute as to whether SM-13496 was known to be Lurasidone. Petitioner
`also cited a WO to show that SM-13496 was in fact known to be Lurasidone
`ten months before the earliest application in the chain.
`Patent Owner never tried to swear behind. Therefore, on the record it
`was known that SM-13496 in Horisawa was Lurasidone and now if we go to
`the next page, page 16, we can see what Horisawa, and this was in the
`petition, said about SM-13496 which is Lurasidone. The results suggested
`that this compound would improve schizophrenia, that's Lurasidone, and it
`was suggested that its circulatory system and central depression side effects
`and body weight increasing action are weak. This teaches that Lurasidone is
`expected to have a weak effect on increasing weight and even Olanzapine
`had less than 50 percent so of course it was expected that at least one patient
`with Lurasidone would not gain weight. Maybe that's all I should say now
`about weight unless there's something that Your Honor would like to hear.
`I'm not hearing anything. Would Your Honor like to hear anything more
`about weight? I'm not sure if I'm hearing Your Honor. Is Your Honor on
`mute perhaps?
`JUDGE YANG: Can you hear me?
`MR. WEINSTEIN: Now I can hear you.
`JUDGE YANG: Okay. No, yes, I don't have any questions on the
`weight gain part and just so you know you have your -- this is your five
`minutes notice. You've done 25 minutes already.
`MR. WEINSTEIN: Thank you. Thank you. And so if we go to page
`11 of Petitioner's demonstratives that showed all the admissions of prima
`facie obviousness and we don't have to go through them one by one but one
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`IPR 2020-01053
`Patent 9,815,827 B2
`of the things Dr. Stahl, their expert, said was talking about treating
`schizophrenia with Lurasidone and he called that a profound statement of the
`obvious. He also called the '827 patent a logical outcome of Saji patent.
`JUDGE YANG: What does it mean a logical outcome, counsel?
`MR. WEINSTEIN: Those were his words. Sounds to me like once
`you had Saji patent it was obvious to do the '827 patent, but that's what Dr.
`Stahl said, logical outcome. Now very briefly, Petitioner would like to turn
`to nexus and of course a nexus requires -- objective indicia require a nexus
`to something that's novel and when we examined Patent Owner's expert
`about this and I wanted to ask them about the nexus to something novel. So
`I asked him what is novel in the claims of the '827 patent. Neither expert
`could say anything was novel. So I had a lot of trouble examining them on
`novelty when neither of them could say what was novel and, you know, I
`think that defeats all evidence of nexus because they couldn't say that
`anything was novel. We of course know that Lurasidone was not novel and
`5 to 100 milligrams was not novel, and oral was not novel and the Saji
`amendment says it was expected to be used for schizophrenia and manic
`depressive psychosis so there was nothing novel, so all of the objective
`indicia fall away because there's no nexus to anything that was novel.
`I talked about Horisawa. Very briefly Dr. Kosten did not recant on
`the schizophrenia claims and this is page 13 of Petitioner's exhibits. Excuse
`me, it's not page 13, it is page 17 of Petitioner's exhibits. He testified he
`didn't have an objection to the schizophrenia claim, Dr. Kosten. What he
`meant was that the clinical data in the '827 patent demonstrated the safety
`and efficacy of using Lurasidone for schizophrenia. He wasn't saying he
`didn't have an objection over the prior art. What he said was there was
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`IPR 2020-01053
`Patent 9,815,827 B2
`written description of schizophrenia in the '827 patent. He didn't recant his
`opinion on obviousness and he says that, Dr. Kosten, in his supplemental
`declaration.
`Finally, I would just like to point out that Dr. Stahl was a respected
`member of the psychiatric community. He did undermine his own
`credibility in talking about the Wong reference. He said, and this is page 18,
`that Wong teaches that it was necessary to co-administer the two drugs in a
`single formulation. This is page 18. But that's not what Wong says. Wong
`says that the two drugs may be given separately and at different times over a
`24 hour period. That's the exact opposite of single formulation.
`Now Patent Owner tried to redefine what was meant by single
`formulation and that's at page 19 of Petitioner's exhibits where they said in
`other words, single formulation means both single unit dose and separate
`administration. Single formulation does mean single unit dose, but single
`formulation does not mean separate administration. That's not credible and
`they did not rehabilitate Dr. Stahl, and unless there's any more questions I'll
`reserve the rest of my time for rebuttal, Your Honors.
`JUDGE YANG: All right. Let's move on to Patent Owner.
`MR. SHEAR; Good afternoon, Your Honor. If I might I'd like to
`reserve 20 minutes for rebuttal.
`JUDGE YANG: Okay, 20 minutes and that gives you 40 minutes
`now. I will try to do the same thing, give you five minutes notice but if you
`could keep track of your own time that'll be very helpful. You may begin
`whenever you're ready.
`MR. SHEAR: Thank you, Your Honor. May it please the Board.
`Again, my name is Chad Shear. I'm the attorney representing DSP in this
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`IPR 2020-01053
`Patent 9,815,827 B2
`proceeding, the Patent Owner. This case is actually fairly unique in my
`experience in that once you put aside sort of the misleading selective
`quotations and the ignoring or misconstruing of evidence, it's remarkable in
`that on all of the salient material pieces that the Board actually needs -- all
`the material salient pieces of evidence that the Board needs to consider to
`decide this case the experts actually agree or the evidence is entirely
`unrebutted. This is not a situation where the Board needs to review
`competing evidence from two different experts and make almost a
`credibility or a decision on weight. For all intents and purposes, the
`evidence is (audio interference).
`What I'd like to do is first deal with priority. Explain why we believe
`and frankly why the HP7, why the manic depressive psychosis claims are
`entitled to the August, 2002 priority date and then I'll move on and deal with
`the ground 3 obviousness argument.
`Where I'd like to start before I begin with any specific slide or before I
`begin addressing some of the comments made by counsel, where I'd like to
`begin is with a discussion of schizophrenia and manic depressive psychosis
`generally because it's important to understand some of the background here.
`Schizophrenia, manic depressive psychosis, these are all diseases that
`are essentially psychosis-based. They're not diseases that you can do a
`blood test for. They're not diseases that you can take an x-ray or an MRI to
`figure out if a patient has them. A doctor looks at the symptoms that the
`patient presents with and then deals with treating those symptoms.
`With respect to schizophrenia, there are two different sort of
`categories of symptoms. There's positive symptoms, that's hallucinations,
`that's delusions, and there are negative symptoms. Those tend to be more
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`IPR 2020-01053
`Patent 9,815,827 B2
`cognitive-based, can present like depression. The positive symptoms, those
`are driven by psychosis. They're driven by excess dopamine in the body.
`The manic depressive psychosis, the manic phase is the same as the present-
`day schizophrenia. It's hallucinations. It's delusions, and it too is caused by
`excess dopamine. Excess dopamine is the culprit for both of those
`conditions and both of those conditions present to a doctor as psychosis.
`These are important distinctions because of a few things. One, to
`address some of the comments that counsel made but two, and importantly,
`to look at why the experts actually agree on the underlying evidence that
`supports why priority is correct here.
`So Dr. Stahl testified, and I'll refer to the patent. I think it's been well
`established that for all intents and purposes the specification of the patent
`and the specification of the provisional application that was filed in August
`of 2002 are identical. Dr. Stahl has explained how a person of skill in the art
`would read the '827 patent and what Dr. Stahl has explained is that as a
`person of skill, when he reads the patent what he reads the disclosure as is
`teaching treating psychosis, whether that's talking about schizophrenia,
`whether that's looking at the BPRS data, whether that's looking at the BPRS
`data, whether that's looking at the PANSS data, all of those things are
`measures of treating psychosis.
`What was known before the '827 patent and what was disclosed in
`Saji was that Lurasidone can inhibit the production of dopamine. It binds
`well to D2. D2 is the receptor that modulates production of dopamine in the
`body and that Lurasidone can reduce the amount of dopamine in a patient.
`Once a person of skill in the art, as Dr. Stahl explains, once a person of skill
`in the art understands that they know that that candidate, whatever that
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`IPR 2020-01053
`Patent 9,815,827 B2
`candidate is whether it's Lurasidone or something else, if it can bind to D2
`and reduce dopamine production it can treat the positive symptoms of
`schizophrenia as well as the manic phases of manic depressive psychosis.
`They overlap.
`JUDGE YANG: So counsel, I have a question there.
`MR. SHEAR: Sure. Of course, go ahead.
`JUDGE YANG: So do I understand this correctly. Besides the
`positive category of the schizophrenia there is also I think you said negative;
`right? And besides the manic side of the bipolar there is also the depressive
`side which means a drug could treat schizophrenia without addressing the
`excessive dopamine; do I understand that correctly? And if that is the case,
`then would that drug still treat manic depressive psychosis?
`MR. SHEAR: So, Your Honor, if I understand your question
`correctly and if I don't please correct me, but if I understand your question
`correctly what you're asking is whether or not a drug that doesn't inhibit
`dopamine production could treat essentially the negative phase of
`schizophrenia and what we call the depressive phase of manic depressive
`psychosis and --
`JUDGE YANG: Right.
`MR. SHEAR: Am I correct?
`JUDGE YANG: Generally in that -- generally, not that specific.
`What I'm trying to figure out is wouldn't there be -- I do understand you are
`saying the manic phase of the bipolar and I'll just use the phrase bipolar, it is
`easier than instead of the old name and the positive category of the
`schizophrenia -- I understand there are overlapping symptoms, but what I'm
`trying to say is there are non-overlapping symptoms; right? We're not
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`IPR 2020-01053
`Patent 9,815,827 B2
`saying it's a total overlap. So what I'm trying to figure out is whether a drug
`that treats the non-overlapping side of the schizophrenia, would that still
`have any effect on the bipolar disorder?
`MR. SHEAR: So the simple answer to your question is, Your Honor,
`I don't know and the answer to that question certainly isn't in this record.
`The positive phase is driven by excess dopamine. The negative phase,
`whether or not that's dopamine driven or not I don't know and I apologize for
`not knowing and certainly none of the experts discussed that. Under manic
`phase, on the depressive phase and again and maybe, I can see you shaking
`your head