Trials@uspto.gov
`571-272-7822
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`Paper No. 34
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`NEPTUNE GENERICS, LLC,
`Petitioner,
`
`v.
`
`CORCEPT THERAPEUTICS, INC.,
`Patent Owner.
`____________
`
`Case IPR2018-01494
`Patent 8,921,348 B2
`____________
`
`Record of Oral Hearing
`Held: November 19, 2019
`____________
`
`
`
`Before TINA E. HULSE, ROBERT A. POLLOCK, and DAVID COTTA,
`Administrative Patent Judges.
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`Case IPR2018-01494
`Patent 8,921,348 B2
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`APPEARANCES:
`
`ON BEHALF OF THE PETITIONER, NEPTUNE GENERICS, LLC
`
`KENNETH M. GOLDMAN, ESQUIRE
`LEONARD A. GAIL, ESQUIRE
`Massey & Gail LLP
`50 East Washington Street, Suite 400
`Chicago, Illinois 60602
`kgoldman@masseygail.com
`lgail@masseygail.com
`
`
`
`
`
`
`
`CHRISTOPHER L. MAY, ESQUIRE
`Massey & Gail LLP
`1325 G Street N.W., Suite 500
`Washington, DC 20005
`cmay@masseygail.com
`
`JOSHUA HARRIS
`Neptune Generics, LLC
`353 North Clark Street, Suite 2700
`Chicago, Illinois 60654
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`Case IPR2018-01494
`Patent 8,921,348 B2
`
`
`
`ON BEHALF OF THE PATENT OWNER, CORCEPT THERAPEUTICS,
`INC
`
`
`
`
`
`
`
`DAVID P. FRAZIER, PH.D., ESQUIRE
`ROBERT STEINBERG, ESQUIRE
`Latham & Watkins LLP
`555 Eleventh Street, N.W., Suite 1000
`Washington, DC 20004
`david.frazier@lw.com
`bob.steinberg@lw.com
`
`MICHELLE L. ERNST
`Latham & Watkins LLP
`885 Third Avenue
`New York, New York 10022
`michelle.ernst@lw.com
`
`JOSEPH K. BELANOFF, CEO
`CHARLIE ROBB, CFO
`Corcept Therapeutics, INC.
`149 Commonwealth Drive
`Menlo Park, California 94025
`
`
`
`
`The above-entitled matter came on for hearing on November 19,
`
`2019, commencing at 1:00 PM ET, at the U.S. Patent and Trademark Office,
`600 Dulany Street, Alexandria, Virginia.
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`Case IPR2018-01494
`Patent 8,921,348 B2
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`P R O C E E D I N G S
`- - - - -
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`USHER: All rise.
`
`JUDGE POLLOCK: Please sit down. Good afternoon. This is the
`
`final hearing in IPR2018-01494 regarding U.S. Patent Number 8,921,348.
`Petitioner is Neptune Generics, LLC; Patent Owner is Corcept Therapeutics,
`Incorporated. As set forth in our scheduling order of October 22, each side
`has 60 minutes to present its case. I'm Judge Pollock. Judges Hulse and
`Cotta are attending remotely from San Jose and Boston, respectively.
`
`Counsel for Petitioner, would you kindly identify yourself and your
`colleagues?
`
`MR. MAY: Good afternoon, Your Honor. Christopher May and Ken
`Goldman from Massey & Gail, LLP, representing Petitioner Neptune
`Generics, and with us is Mr. Leonard Gail, also of Massey & Gail, and Mr.
`Joshua Harris of Neptune Generics.
`
`JUDGE POLLOCK: Counsel, would you like to set aside a portion of
`your time for rebuttal?
`
`MR. MAY: Yes, we would like 10 minutes for rebuttal.
`
`JUDGE POLLOCK: Ten minutes. Counsel for Patent Owner, would
`you kindly identify yourself?
`
`MR. FRAZIER: Afternoon, Your Honor. David Frazier from Latham
`& Watkins for the Patent Owner. I'm joined today by Michelle Ernst and
`Bob Steinberg also from Latham & Watkins. We also have today with us
`Charlie Robb who is the CFO of Corcept and we're also joined by Dr.
`Joseph Belanoff who's the CEO of Corcept and also the inventor on the 348
`(inaudible) patent that we're talking about today.
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`JUDGE POLLOCK: Welcome, Mr. Frazier. Our trial order permits
`
`Patent Owner to reserve time for sur-rebuttal. Would you like to take
`advantage of that opportunity?
`
`MR. FRAZIER: I'd like five minutes, if I could, Your Honor.
`
`JUDGE POLLOCK: Okay, a few matters of housekeeping before we
`begin. I'd like to remind the parties that this hearing is open to the public,
`and a full transcript of the hearing will be made part of the record. Most
`importantly, when you refer to an exhibit on the screen, please state the slide
`or page number for the record. This very important both for clarity of the
`record and because Judges Hulse and Cotta are following on courtesy copies
`of the demonstratives and they're unable to see what you're pointing to on
`the slide on the screen.
`
`In addition, in today's presentations it would be helpful for the parties
`to address first whether a person of ordinary skill in the art would have
`considered blood serum levels to modify dosage for the drugs used to treat
`psychiatric disorders, and second, whether Sitruk-Ware's disclosure of blood
`serum levels of 2,000 nanogram per mL, assuming that number to be
`accurate, meets the claim requirement for a blood serum level of 1,300
`nanogram per mL. That said, the parties of course are free to allocate the
`times they see fit.
`
`MR. GOLDMAN: Could you repeat those two points?
`
`JUDGE POLLOCK: Sure. Whether one of ordinary skill in the art
`would have considered blood serum levels to modify dosage for the drugs
`used to treat psychiatric disorders, and whether Sitruk-Ware's disclosure of
`blood serum levels of 2,000 nanograms per mL, assuming that is accurate,
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`Case IPR2018-01494
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`meets the claim requirement for a blood serum level of 1,300 nanogram per
`mL.
`Okay, Mr. May or Mr. Steinberg, are you prepared to begin?
`
`MR. GOLDMAN: Mr. Goldman.
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`JUDGE POLLOCK: Goldman.
`
`MR. GOLDMAN: Yes. That's okay.
`
`JUDGE POLLOCK: Sorry about that.
`
`MR. GOLDMAN: No worries.
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`JUDGE POLLOCK: All right, we have 50 minutes on the clock with
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`10 minutes reserved for rebuttal.
`
`MR. GOLDMAN: Thank you.
`
`JUDGE POLLOCK: Please begin when you're ready.
`
`MR. GOLDMAN: Sure. Your Honor, I'd like to take a brief moment
`to address the questions that you've just presented. The first one, whether a
`person of skill in the art would have considered the blood serum -- to test the
`blood serum levels in treatment of psychiatric disorders. I would say, Your
`Honor, that I don't think so, but even if that were true, the claims are not
`limited to psychiatric disorders, so I don't believe that the question is
`relevant, at least not for claim 1.
`
`JUDGE COTTA: Counsel, but the art that you rely on as a basis for
`your grounds of obviousness does relate to psychiatric disorders, does it not?
`
`MR. GOLDMAN: Yes, that's true.
`
`JUDGE COTTA: So doesn't that make it relevant?
`
`MR. GOLDMAN: Yes, I believe so, but, again, I don't believe that --
`you're talking about the -- and for ground 2 or for ground 1, or for both
`grounds?
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`JUDGE COTTA: Well, my understanding is that all of the references
`
`that are relied on in connection with grounds 1 and 2, with the exception of
`Sitruk-Ware are relating to psychiatric disorders.
`
`MR. GOLDMAN: Yes, that's correct. And, I'm sorry. Have I
`answered your question?
`
`JUDGE COTTA: I'm just trying to figure out why it would not be
`relevant whether someone would look to blood serum levels in treating a
`psychiatric disorder.
`
`MR. GOLDMAN: Yes, I think that --
`
`JUDGE COTTA: -- if the art that you're relying on relates to that
`subject matter.
`
`MR. GOLDMAN: I think they would. But I think in addition to that,
`I also believe that the claims are not limited to psychiatric disorders. But,
`yes.
`JUDGE COTTA: Okay.
`
`JUDGE POLLOCK: And what is the evidence in the record that they
`
`would rely on blood levels to treat psychiatric disorders?
`
`MR. GOLDMAN: For example, the Belanoff 848 reference has
`numerous references to testing of blood serum levels. I don' have the
`paragraph with me, but I believe it's maybe 88 or 96, those portions. They
`talked about measuring blood serum levels of glucocorticoid receptor
`antagonists.
`
`JUDGE COTTA: Are you referring to Paragraph 41?
`
`MR. GOLDMAN: I'm -- is that -- I believe so, yes.
`
`JUDGE COTTA: Which says “because a patient's metabolism,
`clearance rate, toxicity levels, et cetera, differs with variations in underlying
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`primary and secondary disease conditions, drug history and age, general
`medical condition and the like, it may be necessary to measure blood and
`urine levels of GR antagonists.”
`
`MR. GOLDMAN: That's correct.
`
`JUDGE COTTA: That's the reference you're referring to?
`
`MR. GOLDMAN: That's correct.
`
`JUDGE COTTA: Okay.
`
`MR. GOLDMAN: Next line?
`
`JUDGE COTTA: Did --
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`MR. GOLDMAN: I'm sorry. Go ahead.
`
`JUDGE COTTA: Do you agree with --
`
`MR. GOLDMAN: Go ahead.
`
`JUDGE COTTA: Do you agree with Patent Owner that Belanoff 848
`does not actually use blood and urine levels to adjust dose?
`
`MR. GOLDMAN: Are you talking about the claims or the
`specification or what part of Belanoff are you referring?
`
`JUDGE COTTA: Is there anywhere in Belanoff 848 where it uses
`blood serum levels to --
`
`MR. GOLDMAN: No.
`
`JUDGE COTTA: -- adjust the dose? No, okay.
`
`MR. GOLDMAN: No. There's a mention of it in the prophetic
`example number 4, but no one -- but it's never actually done.
`
`JUDGE COTTA: Okay.
`
`MR. GOLDMAN: And then the second question, whether the Sitruk-
`Ware 2,000 nanogram per mL level meets the claim level of greater than
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`1,300 nanograms per mL and I think the answer is: Yes, I believe 2,000 is
`greater than 1,300 nanograms per mL unless I misunderstood your question.
`
`JUDGE COTTA: Well, okay. So let me ask you this: Do you agree
`that the claim requires a measurement be taken after seven days?
`
`MR. GOLDMAN: Yes.
`
`JUDGE COTTA: Okay, can you explain how the measurement that's
`disclosed in Sitruk-Ware which requires -- or which was taken after a single
`dose is representative of a dosage after seven days?
`
`MR. GOLDMAN: Well, Sitruk-Ware is cited by Petitioners for one
`purpose only, to show that a dosage of 600 milligrams which one of the
`references, the Belanoff reference, says is a generally effective dosage level,
`so 600 milligrams will result in a level of greater than 1,300 nanograms per
`mL, so 2,000 nanograms per mL is evidence of what an effective dosage
`level would result -- what serum level would result in the patient given an
`effective dose of mifepristone. So the Sitruk-Ware reference sits by itself
`for it just to show the level that's achieved by a 600 milligram dose, and you
`have to read that in conjunction with the Belanoff reference which tells you
`that 600 milligram dosages were generally effective.
`
`JUDGE COTTA: Okay, but how do we extend that single dose to a
`dose that's taken after seven days which is, you just agreed, required by the
`claim?
`
`MR. GOLDMAN: Seven daily doses. Well, so first of all, there's no
`limitation in the claim as to when after seven days that dosage is measured.
`You can imagine right after the seventh dosage, the levels would certainly be
`greater than 2,000 based on the Sitruk-Ware number because it would have
`just achieved -- I mean, you have that plus the six doses behind you. It
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`Case IPR2018-01494
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`doesn't take much to infer that, that level will have been -- will be greater
`than 2,000 nanograms per mL right after the seventh dosage. We can talk
`about when it's supposed to be measured, but certainly at that time, it will be
`greater than 2,000 nanograms per mL.
`
`JUDGE COTTA: So the Patent Owner's exhibit 10 -- sorry, it's
`Petitioner's exhibit 1013 which is --
`
`MR. GOLDMAN: The Heikinheimo reference?
`
`JUDGE COTTA: -- reference.
`
`MR. GOLDMAN: Yes.
`
`JUDGE COTTA: That includes a table 1, and it shows that the dose,
`at least in some instances, drops after it's -- I'm sorry -- the serum level drops
`after drug has been administered for an extended period of time. Does that
`provide a basis for questioning whether the dose in Sitruk-Ware, which is
`taken after one day, is not representative of what the serum level would be in
`a patient if it was measured after seven days?
`
`MR. GOLDMAN: Well, I'm not sure, but I don't believe that table
`has any 600 milligram doses which is the dosages that we're talking about.
`They are 25, 50, and 100 twice a day for 4 days, so I mean, we could
`hypothesize and theorize a lot about what you might read out of this table,
`but the 600 -- the point of Sitruk-Ware, of course, is the 600 milligram doses
`which is the effect of doses which are not the dosage that are in table 1, so
`I'm not sure that you can make any conclusions about what would happen if
`you gave 600-milligram doses every single day.
`
`You have to understand when we filed the IPR, you know, we did not
`believe it made any difference at what time you did these measurements, so,
`you know, that's all stuff that's -- these are limitations that are found
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`nowhere in the specification in the claims and the file wrapper history, so we
`just picked a number. I mean, I don't want to hypothesize, but, you know,
`we could probably find other references with other numbers. This is the
`number that we chose to use in our IPR.
`
`JUDGE COTTA: Okay. So your --
`
`MR. GOLDMAN: Yes?
`
`JUDGE COTTA: -- argument with respect to table 1 -- your position
`with respect to table 1 is that it doesn't show that the dosage would drop at
`600 milligrams which is the dose that's relied on in Sitruk-Ware; is that a fair
`summary?
`
`MR. GOLDMAN: That's a fair summary of what I've just said. Yes,
`that's correct.
`
`JUDGE COTTA: Okay. Is there anything you could point me to that
`would show what we would expect the dose to be after seven days for 600
`milligrams?
`
`MR. GOLDMAN: I'm not sure if there is anything on the record. I
`know that there are -- I don't have that anything -- with me at the moment.
`I'm happy to come back in rebuttal to see if there's anything with the
`references we have.
`
`JUDGE COTTA: Yes, that would be helpful. Thank you.
`
`MR. GOLDMAN: Okay.
`
`JUDGE COTTA: And then could you briefly address -- there's a
`dispute between the parties as to whether the claims require a Cmax or a Cmin.
`Could you briefly address that?
`
`MR. GOLDMAN: I will do that in my presentation. Would you like
`-- I can do that right now if you'd like?
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`JUDGE COTTA: Sure.
`
`MR. GOLDMAN: Can you move to slide -- I talked about several
`
`times. I want it -- can you start to --
`
`SPEAKER: This one's slide 11.
`
`MR. GOLDMAN: Slide 11. I'm sorry. Say that -- I want to make
`sure I'm getting the right thing. Could you please repeat the question one
`more time?
`
`JUDGE COTTA: Sure. I was talking about the dispute as to whether
`the claims require a particular measurement, either Cmax or Cmin
`measurement at trough, measurement at a particular time, and there seems to
`be agreement that the serum level has to be measured after seven days.
`
`MR. GOLDMAN: That's correct.
`
`JUDGE COTTA: Is that right?
`
`MR. GOLDMAN: Mm-hmm.
`
`JUDGE COTTA: Okay, so does it require anything else beyond that?
`
`MR. GOLDMAN: No, it --
`
`JUDGE COTTA: If not, why not?
`
`MR. GOLDMAN: No, it doesn't. Can you go to slide 6, please? I
`will just say there is an issue as to when and how to measure mifepristone
`serum levels. Step 3 says adjusting the daily doses of the patient to achieve
`blood levels greater than 1,300 nanograms per mL, and certainly the claim is
`silent about when one should measure those levels to see if you have
`achieved a certain level. That it doesn't say right after the dose, which is
`Cmax, or sometime later, Cmin, or steady state or the trough level or right
`before the next dose, and I just want to point out that the same issue is
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`present in step 2 which says testing the serum levels to determine whether
`the blood levels are greater than 1,300.
`
`Again, it says nothing about when to test serum or blood levels, and I
`would say that under the broadest reasonable interpretation standard there is
`nothing here to limit when you should measure these claims. Let me say a
`little bit more about that, though, now slide 11. The Patent Owner's own
`experts are split on this. On the left-hand slide, this is slide 11. I'm
`supposed to tell you what slide we're on, is that correct? You guys --
`
`JUDGE COTTA: Yes, that's helpful. Please.
`
`MR. GOODMAN: Good. Slide 11 the Patent Owner's experts are
`split. On the left the first expert says the measured level is at steady state or
`trough, which are, again, terms never used in the specification in the claims
`or the file wrapper history, and on the right, their other expert says that the
`claim does not require a measurement at any given time. In any case, I think
`an expert test -- if you turn to slide 13, an expert’s testimony can't be used to
`alter the plain and ordinary meaning of the claims.
`
`Back on slide 12, I just want to mention that one of the things the
`Patent Owner pointed out is that we supported our argument with a paper
`that showed measuring trough levels. If you see on the left that trough levels
`were collected on day seven. However that is, the paper on the right you can
`see is from 2017, and it's obviously irrelevant to what a person of skill in the
`art would have thought in 2007, and one of the inventors -- one of the
`authors on that paper, Kalin, actually said the opposite in terms of this claim.
`That's my position.
`
`JUDGE COTTA: Okay.
`
`MR. GOLDMAN: Okay? So let's go back to slide 2.
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`Case IPR2018-01494
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`JUDGE COTTA: Let me ask you one more question.
`
`MR. GOLDMAN: Please.
`
`JUDGE COTTA: Is this properly an issue of claim construction or is
`
`this something else?
`
`MR. GOLDMAN: I imagine it -- you mean definite? I mean is it
`definiteness or something?
`
`JUDGE COTTA: There was some dispute in your briefing as to
`whether the Patent Owner had raised this properly as an issue of claim
`construction and I think there was some back and forth on that. I just
`wanted to see is this a claim that we need to construe?
`
`MR. GOLDMAN: Well, so in our initial IPR of course, there wasn't
`any indication that this would be an issue, so we did not raise it as an issue
`of claim construction in our brief. I don't believe that the Patent Owner
`raised it as an issue of claim construction in their brief either, however we
`believe that at least the way they talked about it in their papers that it at least
`implicitly raises a level -- an issue of claim construction.
`
`JUDGE COTTA: Okay.
`
`MR. GOLDMAN: Slide 2. This seems anticlimactic, but slide 2 is --
`here's claim 1. The preamble says a method for optimizing levels of
`mifepristone in a patient suffering from a disorder amenable to treatment
`with mifepristone. This clearly, it's not a normal method of treatment claim.
`It's a method of optimizing the method of treatment claim, and it really, as I
`think the Board agreed, it just describes the context in which the steps are to
`be taken to optimize mifepristone treatment in a patient.
`
`I'll go really quickly through the slides. Slide 3, the first step is
`treating the patient with seven or more daily doses of mifepristone. Next
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`Case IPR2018-01494
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`slide, slide 4, the second step is testing mifepristone serum levels to see if
`mifepristone blood level is greater than 1,300 nanograms per mL, and then
`finally on slide 5, step 3 is the third step, adjusting the daily dose to achieve
`mifepristone levels greater than 1,300 nanograms per mL. So it's pretty
`simple and straightforward. First treat the patient to get drug in the blood.
`Second, test the serum and blood levels for their blood level of mifepristone,
`and then finally adjust the dosage presumably only if necessary. The claim's
`quite specific, as you pointed out, when and how to treat the patient, seven
`or more daily doses over seven more days, but the second and third steps say
`nothing about when or how to test and when or how to adjust.
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`Your Honors, here's our position in a nutshell. The use of
`mifepristone to treat a wide array of disorders, both mental and otherwise,
`was described in numerous patents, patent applications, and printed
`publications before the critical date of the 348 patent. Doctors and clinicians
`are naturally inclined to optimize dosage regiments for such treatment. They
`were therefore highly motivated to find an optimal drug serum level and
`finding that exact level was routine. The case law tells you this, the Board
`acknowledged it in its Decision to Institute, and really, common sense tells
`you that doctors want to optimize their treatments. That's not -- so the
`motivation is clearly there.
`
`The main thrust of Patent Owner's position is that there were
`numerous obstacles to finding that level. But to the extent that they are real
`at all, those obstacles were not only known in the art and in no way
`discovered or improved on by Dr. Belanoff, the inventor, but several of these
`factors actually would have pushed the skilled clinician toward measuring
`serum levels in this context in finding a threshold level for the drug. So
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`Case IPR2018-01494
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`accordingly the art combines with the natural inclinations of a skilled
`clinician to seek and routinely find an optimization method for the claim
`treatments.
`
`More specifically, in ground 2, the ground on which the Board
`initiated this review, Petitioner showed that claim 1 is obvious over three
`journal articles, two of inventors on articles in view of a third review article
`and I will be presenting that ground, and in ground 1, we show that a single
`piece of inventor's prior art teaches a method for treating a disorder and it
`contains a roadmap for optimizing that method, and my colleague Mr. May
`hopefully will get a chance to present that ground. And regarding the
`remaining grounds, the parties essentially agree on grounds 3 to 6, that they
`stand or fall together with their parent grounds 1 or 2. If I'm wrong, I'm sure
`you guys will correct me.
`
`So on the next slide, 7, let me talk a little bit about one other implicit
`claim construction issue which is regarding the term "disorder", and we're
`happy to agree that the disorder refers to a disorder amenable to treatment
`with mifepristone as set forth in the specification. However the Patent
`Owner in its response is sometimes, as we said in our reply, a bit cagey and
`often suggests a more narrow interpretation of disorder. I put a couple of
`examples, and you'll see that in the first one at page 11, there was less
`development and understanding in the art -- I'm on slide 7 now.
`
`I'm sorry. There was less development and understanding in the art
`with respect to the drugs' anti-glucocorticoid properties in relevant
`applications such as the mental disorders described in the 348 patent
`including for Cushing's Syndrome, and we want to make one thing clear;
`this proceeding is governed by the broadest reasonable interpretation
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`standard. Disorder is not limited in this patent to chronic disorders or mental
`disorders although we believe it does include Cushing's Syndrome which is
`not a mental disorder, and I have a citation for that in the Kalin deposition at
`page 96, lines 1 through 5, Cushing's Syndrome is a primary disorder of the
`endocrine system.
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`JUDGE POLLOCK: Mr. Goldman. How does the breath we give the
`term "disorder" impact on your grounds?
`
`MR. GOLDMAN: Well, because the Patent Owner will argue as you
`probably will see that many of the factors leading towards non-obviousness
`have to do with the field of psychiatry and antidepressants in particular, and
`although that may be true, the claim is not so limited, so any suggestions that
`they make that's saying that this claim is non-obvious because of how the
`drug may or may not, or how drugs generally may or may not act in
`psychiatric indications is not relevant to the obviousness of claim 1.
`
`JUDGE POLLOCK: But isn't the art you rely on relating to
`psychiatric disorders?
`
`MR. GOLDMAN: Yes, but that has nothing to do with --
`
`JUDGE POLLOCK: Well, why does it matter if we read the term
`"disorder" more broadly than as used in the art that you're focusing on? I'm
`kind of confused.
`
`MR. GOLDMAN: I mean, the claim -- this is not our argument. This
`is the Patent Owner's argument. They're arguing that the claim is not
`obvious because of how drugs act in the field of psychiatry.
`
`JUDGE COTTA: So the argument that you're making as I understand
`is that you are trying to optimize a treatment that's disclosed in the art that
`relates to psychiatry; is that right?
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`MR. GOLDMAN: It relates, among other things, to psychiatry. The
`
`only indication for this drug is for Cushing's Syndrome which is not a
`psychiatric disorder, not that that is relevant, but the claims -- so I'll tell you
`what --
`
`JUDGE COTTA: Let me just interject, I think -- I'm not sure I'm
`understanding your argument or maybe I'm confused by Patent Owner's
`argument, but the definition that Patent Owner has put forward is the
`definition that's in the patent. It says in the patent in column 3, "The term
`‘amenable to treatment by mifepristone’ refers to a condition that is known
`to be treated by a glucocorticoid antagonist such as mifepristone” --
`
`MR. GOLDMAN: Mm-hmm. Correct.
`
`JUDGE COTTA: -- “conditions such as mental disorders discussed
`below are “amenable to treatment by mifepristone." I don't read that
`definition as being limited to mental disorders although it does appear to be
`limited to glucocorticoid antagonist.
`
`MR. GOLDMAN: And I would agree the -- well, first of all, let me
`just say that I have a bunch of slides that I have a bunch of slides that I was
`just about to show and I won't run through them, but the 348 patent is the
`daughter of a parent patent, the 149 patent in which the word "mental
`disorder" is found. Now, the preliminary amendment filed in this case, the
`first thing they did was strike the term "mental", so I would put forward to
`you that clearly these claims are not limited to mental disorder. They're
`broader than just mental disorders. So these claims cover psychiatric
`disorders as well as non-mental disorders such as Cushing's Syndrome or
`Cushing's Disease, a disease of the endocrine system.
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`Now to Judge Pollock, I want to, you know, get back to your question.
`
`Yes, our references, and as we already discussed at the beginning, are the
`Belanoff and Chu and (inaudible) Belanoff are mental disease references and
`we combined them with Sitruk-Ware, which is not even a glucocorticoid
`receptor disorder, but solely for the pharmacokinetic point that that is
`disclosed in there. But the question about mental disorders is an argument
`that the other side is putting forwards to say that there would be no -- I'm
`sorry -- I'm losing my point here -- that -- I'm sorry -- that there would be no
`suggestion to go forward in mental disorders, but the claims aren't limited to
`that. They have to show that the claim is also not obvious over its entire
`scope.
`
`JUDGE POLLOCK: Well, I think it's Petitioner's burden to come
`forward with an evidence as to why the claims would have been obvious,
`and the argument that's relied on is art that relates to treating mental
`disorders. My understanding of your argument is that it would have been --
`and please correct me if I'm wrong, but that it would have been obvious to
`optimize the dose in these treatments for mental disorders at the blood serum
`level that's taught to be effective.
`
`MR. GOLDMAN: Correct.
`
`JUDGE POLLOCK: Okay.
`
`MR. GOLDMAN: That's correct.
`
`JUDGE POLLOCK: Okay. So then why -- I don’t understand, then,
`what the concern is with the claim construction as to whether the claims are
`limited to a mental disorder since the art that you relied on is relating to
`mental disorders.
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`MR. GOLDMAN: Well, I mean, I just want to make it clear that
`
`they're not -- I mean, we can come back to that later, but it's clear that the
`claims are not limited to mental disorders. I mean, you know, we can't have
`references to cover -- we just use one combination of references that happen
`to be mental disorder references.
`
`JUDGE POLLOCK: Okay.
`
`MR. GOLDMAN: All right, I think I need to move on. Let's go to
`the meat of this. Let's go to slide 14, please. So the Board instituted this
`IPR based on ground two making the following findings, Belanoff 2002
`showed the required patient population, the method of treatment, and a
`generally effective 600 milligram dose as I said earlier. Chu and Belanoff
`showed that adjusting the daily dose to achieve effective dosing and Sitruk-
`Ware showed the 2,000 nanogram per mL serum level, i.e., greater than
`1,300 nanograms per mL was obtainable in patients after a 600 milligram
`dose.
`Now, a brief note here, Sitruk-Ware actually says 2.0 mgs per liter,
`
`that's the same thing as 2,000 nanograms per mL or 2 micrograms per mL,
`there's not dispute about this. I'm using the nanogram per mL serum level in
`this presentation just because that corresponds to the units that were used in
`the claims.
`
`Slide 15. The Board has already seen and preliminarily found that
`every element of the claim was taught in the prior art, and that the references
`taken together, teach or suggest the method of claim 1. I won't go into all of
`these, but I'd like to focus on 3 and 4, which we've actually talked about, so
`point 3, it was known that 600 milligram doses were generally effective, and
`that's the Belanoff reference, and it was known in point 4 that a 600
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`Case IPR2018-01494
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`milligram dose resulted in the mifepristone level of 2,000 nanograms per mL
`in the patient.
`
`Again, I want to emphasize Sitruk-Ware is only cited by us to show
`that a 600-milligram dose can result in a certain level, but in combination
`with Belanoff which shows that a 600-milligram dose is generally effective,
`the two references together teach a person of skill in the art to look to that
`serum level for effective treatment. Now, the Patent Owner is going to
`spend a lot of time discussing Sitruk-Ware in trying to convince you that
`there is no way Sitruk-Ware is relevant, but keep in mind that's it's only
`relevant -- we only use it for a single pharmacokinetic PK data point that
`shows an achieved level. There is no doubt that the data point is correct and
`accurate, as we'll show later, and although it's measured in the contraceptive
`context as we'll show later, that's irrelevant because pharmacokinetics is the
`same for this dr