Trials@uspto.gov
`571-272-7822
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`Paper 50
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` Entered: October 7, 2020
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`__________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`__________
`
`TEVA PHARMACEUTICALS USA, INC.,
`Petitioner
`
`v.
`
`CORCEPT THERAPEUTICS, INC.,
`Patent Owner.
`
`__________
`
`PGR2019-00048
`Patent 10,195,214 B2
`
`__________
`
`Record of Oral Hearing
`Held: September 2, 2020
`__________
`
`Before JACQUELINE WRIGHT BONILLA, Deputy Chief Administrative
`Patent Judge, ROBERT A. POLLOCK, and DAVID COTTA,
`Administrative Patent Judges.
`
`
`
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`571-272-7822
`
`
`Paper 50
`
` Entered: October 7, 2020
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`__________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`__________
`
`TEVA PHARMACEUTICALS USA, INC.,
`Petitioner
`
`v.
`
`CORCEPT THERAPEUTICS, INC.,
`Patent Owner.
`
`__________
`
`PGR2019-00048
`Patent 10,195,214 B2
`
`__________
`
`Record of Oral Hearing
`Held: September 2, 2020
`__________
`
`Before JACQUELINE WRIGHT BONILLA, Deputy Chief Administrative
`Patent Judge, ROBERT A. POLLOCK, and DAVID COTTA,
`Administrative Patent Judges.
`
`
`
`
`
`
`
`
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`
`
`
`PGR2019-00048
`Patent 10,195,214 B2
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`APPEARANCES:
`
`ON BEHALF OF THE PETITIONER:
`
`
`DEBORAH STERLING, ESQ.
`Sterne, Kessler, Goldstein & Fox, P.L.L.C.
`1100 New York Avenue, NW
`Suite 600
`Washington, DC 20005
`202-772-8501
`dsterling-ptab@sternekessler.com
`
`
`
`ON BEHALF OF THE PATENT OWNER:
`
`
`ERIC STOPS, ESQ.
`Quinn, Emanuel, Urquhart & Sullivan
`51 Madison Avenue
`22nd Floor
`New York, New York 10010
`212-849-7561
`ericstops@quinnemanuel.com
`
`
`
`
`The above-entitled matter came on for hearing on Wednesday,
`
`September 2, 2020, commencing at 10:03 a.m. EDT, via Videoconference.
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`P-R-O-C-E-E-D-I-N-G-S
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`10:03 a.m.
`JUDGE COTTA: Good morning. This is the final hearing in
`PGR2019-00048, regarding Claims 1 through 13 of U.S. Patent Number
`10,195,214. The Petitioner is Teva Pharmaceuticals USA, Inc., the Patent
`Owner is Corcept Therapeutics, Inc. The hearing is open to the public and a
`full transcript of the hearing will be made part of the record.
`I'm Judge Cotta, and with me are Judges Bonilla and Pollock.
`Counsel for Petitioner, could you please identify yourself for the record?
`MS. STERLING: Good morning, Your Honor. My name is
`Deborah Sterling. I'm with the law firm of Sterne, Kessler, Goldstein &
`Fox, and I'm here on behalf of Petitioner Teva Pharmaceuticals, USA, Inc.
`JUDGE COTTA: Thank you. And counsel for Patent Owner, could
`you kindly yourself for the record?
`MR. STOPS: Good morning, Your Honor. This is Eric Stops from
`Quinn, Emmanuel, Urquhart & Sullivan, on behalf of Patent Owner Corcept
`Therapeutics, and with me is Nick Cerrito, also from Quinn, Emmanuel for
`Corcept.
`JUDGE COTTA: Okay. Thank you. As set forth in our hearing
`order of July 16, 2020, each side has one hour to present its case. My
`colleagues will do our best to keep track of time, but we suggest that the
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`parties do the same. Counsel for Petitioner, would you like to reserve any
`time for rebuttal?
`MS. STERLING: Yes, Your Honor, I'd like to reserve 20 minutes,
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`please.
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`JUDGE COTTA: Okay. And, Counsel for Patent Owner, you're
`entitled to the last word today if you wish, would you like to reserve any of
`your time?
`MR. STOPS: Yes, Your Honor. Ten minutes, please.
`JUDGE COTTA: Okay. Before we begin, there are a few things I'd
`like to cover. First, on behalf of the Board, I'd like to thank you for your
`flexibility in participating in this all video hearing. Given that this is a
`departure from our typical practice, I'd first emphasize that our primary
`concern is your right to be heard, so if at any point during the proceeding
`you encounter technical or other difficulties that you feel fundamentally
`undermine your ability to adequately represent your client, please let us
`know immediately.
`Second, when you're not speaking, please mute your microphone.
`Third, for the benefit of the court reporter, please identify yourself each time
`you speak. Fourth, we have access to the entire record, including
`demonstratives, so when you're referring to each paper, or demonstrative, or
`exhibit, please do so by slide or page number, and give us a few seconds to
`find it so we can follow along at home.
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`Finally, should you come to a good faith belief that the pace of this
`proceeding prevents you from adequately explaining your position, please
`speak up and we'll consider expanding the allotted time.
`Petitioner will go first, as it bears the burden of showing
`unpatentability of the challenged claims. Before we hear from Petitioner, we
`understand that the Patent Owner has objected to Slide 42 of Petitioner's
`demonstrative on the basis that it references an exhibit that Patent Owner has
`moved to exclude.
`We've reviewed Slide 42 and we understand the basis for the
`objection. We overrule the objection, as we have not yet resolved Patent
`Owner's motion to exclude. In the event the Panel grants the motion to
`exclude, we're certainly capable of disregarding the material on Slide 42.
`Petitioner, you can begin whenever you're ready.
`MS. STERLING: Good morning, Your Honor. Again, my name is
`Deborah Sterling on behalf of Petitioner Teva Pharmaceuticals USA. Your
`Honor, this case, in part, is a case of routine optimization. Korlym was
`approved in 2012 as a 300mg per day -- or 300mg tablet of mifepristone. It
`was approved for treating Cushing's patients.
`Treatment begins at 300mg per day and it titrated up one 300mg at a
`time, tablet at a time, to 1200mg, as needed, based on physician judgement
`and patient response.
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`My Exhibit 1004, which is the Korlym approval label from 2012,
`recognizes that mifepristone and CYP3A substrate may be co-administered
`with a strong CYP3A inhibitor, sometimes it's ketoconazole. But
`ketoconazole as a CYP3A inhibitor is expected to affect the exposure or
`blood level for simplicity of a CYP3A, or CYP3A, substrate, in this case,
`mifepristone.
`So because the CYP3A will increase exposure of mifepristone,
`recognizing this, the label recommended that when you're co-administering
`mifepristone and ketoconazole, a dose reduction of the mifepristone is
`required, and the label recommended reducing the dose, starting from the
`higher 1200 or 900mg dose that you may have been titrated up to, for
`example, backfilling to 300mg, so backfilling to one Korlym tablet, and if
`you're going to co-administer with ketoconazole.
`My, I believe, Exhibit 1005, which was part of the approval package
`released upon approval of Korlym in 2012 discloses the FDA added this 300
`limitation in the absence of data, indicating the precise extent of the increase
`and exposure of mifepristone with ketoconazole.
`The FDA also imposed a post-marketing requirement on Corcept to
`perform a drug-drug interaction study, or DDI study, I may refer to it as, to
`find, like, the answer to that question, what is the precise extent of the
`increase in exposure of mifepristone with ketoconazole, and they did so in
`order to provide additional dosing options for Cushing's patients.
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`So Corcept did the very study that the FDA mandated it do and then
`claimed the results in the 214 Patent. But during prosecution, Korlym
`overcame -- or Korlym, sorry, Corcept overcame the Korlym label by
`relying on two objective indicia, teaching away and unexpected results, but
`there was no teaching away here, nor was the result that Corcept obtained
`when it followed the drug-drug interaction study it was mandated to do, but
`was not unexpected.
`So I'll do each in turn, first, as to the teaching away, Corcept argues
`that the label taught away from the claimed invention because the label
`recommended reducing the mifepristone dose to 300mg rather than 600,
`when co-administering mifepristone with a strong CYP3A inhibitor, like
`ketoconazole.
`So of course its theory was that this 300mg limitation would have
`discouraged those in the art for trying -- from trying higher doses when co-
`administering mifepristone with ketoconazole, but this argument is
`contraindicated by Lee's disclosure that the FDA requires a 300mg limitation
`of mifepristone and with a ketoconazole as a precautionary measure pending
`the results of the drug-drug interaction study that the FDA had mandated as
`part of the post-marketing requirement for Korlym's approval.
`So given the combination of the Lee document with the Korlym
`label, which the examiner did not raise during prosecution, it's clear the prior
`art would not have discouraged investigation into the invention claimed, to
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`the contrary, the FDA affirmatively encouraged testing other doses than the
`300mg limitation.
`And Corcept simply did what the FDA told and claimed the results.
`So there's no teaching away here. There was a clear following of the path
`laid out in the art.
`Now, Corcept's second argument during prosecution was that even
`following that path, it was surprising that 600mg of mifepristone could be
`co-administered with a strong CYP3A inhibitor, because according to
`Corcept in its submitted declarations during prosecution to this effect, that
`one would have expected a strong CYP3A inhibitor to cause a 7 to 20-fold
`increase in the patient's mifepristone blood level.
`Corcept termed this phenomenon the Greenblatt effect, after Dr.
`Greenblatt, who's a clinical pharmacologist, whom Corcept recognized as
`the preeminent expert in drug-drug interactions involving CYP3A inhibitors.
`Now, that was during prosecution.
`Dr. Greenblatt, in this post-grant review proceeding, has explained in
`his expert declaration that the premise of Corcept's unexpected result
`argument is wrong. Now, while admittedly, a person of ordinary skill in the
`art would not have known the precise --
`JUDGE BONILLA: Ms. Sterling, can I ask a question? Can you
`hear me?
`MS. STERLING: Yes, Your Honor.
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`JUDGE BONILLA: So I'm looking at what I believe is Lee, on the
`first page of Lee, and it specifically says in there that -- it talks about it being
`a safety risk and depriving the patients, due to lack of accurate knowledge,
`but it actually talks about a safety risk, and then also, the prior, the label
`itself, also talks about how these things are unknown and it should use
`extreme caution.
`You think that's something that somebody wouldn't take into
`consideration, that that wouldn't be something that would impact teaching
`away or expected results?
`MS. STERLING: Your Honor, Lee recognizes, as the art does, that
`when you co-administer a CYP3A substrate with a CYP3A inhibitor, you do
`-- you are likely to increase exposure, and the question is, by how much?
`And there was no data.
`Lee makes clear that it made its decision on the 300mg dose in the
`label based on the absence of data. It had asked for studies from Korlym --
`or from Corcept, and Corcept had presented insufficient data for the FDA to
`understand the full study.
`JUDGE BONILLA: Understood. When there's a lack of data, and it
`says there's a safety risk, and two different documents from the FDA are
`telling you that you should use the 300mg dose, don't you think that would
`teach somebody, a person of ordinary skill in the art, to use 300 or less, not
`to jack-up the dose, in light of the words that are in there?
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`MS. STERLING: Well, Your Honor, this caution came with a clear
`instruction and a post-marketing requirement that this drug-drug interaction
`be looked into further. So the FDA limited it to 300, in the absence of data,
`because out of a caution. You know, it was a preliminary precaution
`measure waiting for the data.
`Now, Dr. Greenblatt is the person who would find that data, so he
`would take this, and Dr. Carol has -- that's Corcept's expert, has testified that
`given the 300mg in the label, one would presume that was safe, and then Dr.
`Greenblatt says, well, you're going to go and test the other doses to see what
`else might be safe.
`So, Your Honor, it depends on the lens that you're looking through,
`Dr. Greenblatt, the person that would be performing the drug-drug
`interaction study that the FDA requires --
`JUDGE BONILLA: So let me ask you a question, so one thing that I
`think we do need clarification on from both parties is, what is a person of
`ordinary skill in the art? I think we need to address that. And the claim
`itself is directed to a method of treating Cushing's Syndrome, for example, in
`a patient.
`So it's a method of treatment in a patient. Why wouldn't a person of
`ordinary skill in the art be a physician who would actually treat patients as
`opposed to somebody who just simply studies drug-drug interactions?
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`MS. STERLING: So, Your Honor, let's start with the original
`proposition of ordinary skill in the art that Petitioner set forth in the
`Petitioner. We've reproduced that on Slide 8 for you, and it's found in the
`petition at Page 22, and relies on Dr. Greenblatt's first declaration, Exhibit
`1512 at Paragraph 18.
`And here, let me know when you're there. Okay. So here, we say
`that a person of ordinary skill in the art could have been the pharmacologist
`or the clinician, right, and they would have worked together as a team.
`Now, Daiiachi tells us, Daiiachi Sankyo v Apotex tells us that even
`if you have a method of treating claim, yes, it may be that the physician is
`the person carrying out the claimed method, but it's not necessarily the case
`that that physician sitting in their office is also the person that would develop
`the method of treating in the first place, unless they had additional training
`in that area.
`Typically, what happens in drug development is, there's a team.
`There are pharmacologists, clinicians, they work together, and our person of
`ordinary skill in the art explains that team approach. Now, Corcept's POSA
`is, we created on Slide 9, and discussed in their Patent Owner response at
`Pages 20 to 21.
`Now, Corcept doesn't dispute this team approach --
`JUDGE COTTA: Counsel, can I interrupt you for a second?
`MS. STERLING: Yes, Your Honor.
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`JUDGE COTTA: I'm focusing on the language in your proposal, “or
`alternatively.” So the proposed definition of a POSA, which we adopted in
`our decision on institution, says that a POSA would have at least four years
`of experience treating patients or alternatively, studying drug-drug
`interactions.
`So are you now arguing that the POSA would not include someone
`that has experience treating patients and would be, instead, someone that
`focuses on drug-drug interactions?
`MS. STERLING: No, Your Honor, we have neither excluded the
`clinician treating patients nor the drug-drug interaction expert from the
`POSA team. We include those POSAs. We're not saying that --
`JUDGE COTTA: Okay. And are you suggesting that the “or
`alternatively” should instead be and?
`MS. STERLING: Well, Your Honor, again, it depends on the part of
`the problem being solved. The question that's part of the problem being
`solved. At certain points, the physician should have input and at certain
`points, the drug-drug interaction expert would have input.
`But as we make clear, these POSAs would have been part of a team
`and would have looked to each other and drawn on each other's expertise
`and guidance. The issue with the person of ordinary skill in the art, here, we
`submit the confusion arises, it's an issue of Corcept's own making, Your
`Honor. Corcept doesn't dispute the team approach, it does not dispute Teva's
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`POSA, other than to mandate that the physician discussed in that POSA
`must have experience seeing Cushing patients with mifepristone.
`But Corcept also acknowledges that our POSA definition does not
`exclude that person, so we include it. And we do not try to say that Dr.
`Carroll or Dr. Katznelson are not persons of ordinary skill in the art. Our
`argument was merely that they were approaching the obviousness analysis
`from the wrong perspective.
`JUDGE COTTA: So just to be clear, I'm having a little trouble
`reconciling what you're arguing with the definition that's set forth in your
`petition, but are you now arguing that, for example, a POSA would not be
`just a physician with experience treating patients or, alternatively, just
`someone studying drug-drug interactions, but rather, it would be only a
`multi-disciplinary team?
`MS. STERLING: Yes, Your Honor, and that's what we set forth in
`our petition as well, that the POSA would be part of the multi-disciplinary
`team and would draw --
`JUDGE COTTA: Well, it says, in the petition it says, a POSA might
`-- also might have worked as part of a multi-disciplinary team. I mean, it
`seems like that's an additional suggestion, not -- you're not proposing that
`that's the only definition of a POSA. At least, that's not the way I read it.
`You can correct me if I'm reading it wrong.
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`MR. STOPS: I apologize. I don't mean to interrupt. I got kicked off
`momentarily. Yes, I got kicked off -- this is Eric Stops, I got kicked off
`momentarily while Judge Cotta was speaking. I missed part of the
`discussion. Ms. Sterling, did you also?
`MR. SLAY: The audio cut out in the middle of that discussion from
`the judge.
`JUDGE COTTA: Okay.
`MR. STOPS: Your Honor, would you go back to what you were
`saying? I think we all missed part of your discussion on the POSA.
`JUDGE COTTA: Certainly. And, Ms. Sterling, are you still here?
`Are you able to -- can we hear you?
`MS. STERLING: I'm still here, but -- and everyone is breaking up a
`lot, particularly Mr. Sterling. I'm having a hard time hearing what he was
`saying.
`JUDGE COTTA: Okay. Mr. Sterling was saying that it cutout when
`I was asking the question, so he missed my question. So are you able to
`continue or is your connection too fragmentary to continue? And just so you
`know, I've paused your time. This discussion is not chewing into your time.
`MS. STERLING: Understood. I have a significant lag. I can see
`you speak, and then a garbled --
`JUDGE COTTA: Can we go off the record for a second?
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`(Whereupon, the foregoing matter went off the record at 10:22 a.m.
`and went back on the record at 10:28 a.m.)
`MS. STERLING: Okay. Your Honor, the POSA could be the drug-
`drug interaction expert, it could be the clinician in treating Cushing's
`patients, it could also be the multi-disciplinary team. Your Honor, we're not
`saying it has to be only one or the other. The question arises -- you know,
`the law tells us for a person of ordinary skill in the art, you need to consider
`the types of problems encountered in the art and the prior art solution to
`those problems.
`Now, Corcept itself identified that the present invention came from
`investigations into safety of co-administering mifepristone with CYP3A
`inhibitors. That certainly includes the input from a drug-drug interaction
`expert as well as a clinician, Your Honor. They would come at it from
`different perspectives.
`Now, the issue that we presented in our reply was not that we took
`issue that Corcept's Dr. Katznelson and Dr. Carroll were not persons of
`ordinary skill in the art, the issue that we took was that they approached the
`obviousness analysis from the wrong perspective.
`Now, there are --
`JUDGE BONILLA: Can I ask a quick question about what you just
`said, because one of the questions I have is whether a person of ordinary
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`skill in the art could be, because you were explaining about the three of them
`in the alternative, and that's how I read what you presented in your petition.
`But my question is whether we should find somebody who's just a
`drug-drug interaction expert, who's not an M.D., somebody who has no
`experience treating patients, whether that person by themselves should be
`considered a person of ordinary skill in the art for the purposes of a claim
`directed for treating patients.
`MS. STERLING: Yes, Your Honor. And for two reasons, first,
`what is the problem being solved here? Corcept itself, during prosecution,
`said that the invention arose from investigations into the safety of co-
`administering two drugs.
`The FDA asked for a drug-drug interaction trial. Corcept defended
`its patentability based on the drug-drug interaction phenomena, referring to
`the Greenblatt effect, during prosecution. Now, Diiachi tells us that even if
`the clinician who's practicing -- for a method of treatment claimed, we have
`a clinician that's going to be practicing that method of treatment in the
`office, in their office, but they are not necessarily the same person who is
`going to be involved in the problem that was in the art and the problem the
`patent purported to solve, which is arising at the method of treatment.
`That typically could be a clinician who treats with mifepristone, you
`know, for Cushing's, but they would need additional training and experience.
`That's where the drug-drug interaction aspect comes in here. So you should
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`squarely credit Dr. Greenblatt's testimony because it refutes the very
`arguments Corcept relied on and presented to the patent office during
`prosecution.
`Their interpretation of the Greenblatt effect, of Dr. Greenblatt
`himself, confirmed was incorrect. And that was their hook to get the patent
`out of the patent office. They argued unpatentability based on the Greenblatt
`effect.
`
`JUDGE POLLOCK: Counsel Sterling, if you put forth in your
`petition, three possible definitions of one of ordinary skill in the art, and
`Patent Owner picks one for its perspective, how can you fault them for that?
`Aren't they all valid in your mind? You put them in the petition.
`MS. STERLING: They are, Your Honor. We're not saying -- again,
`we're not saying Dr. Carroll or Dr. Katznelson are not persons of ordinary
`skill in the art for the claims at issue. I'm getting an odd screeching, sorry,
`on the audio. It seems to have gone away. What we're saying --
`JUDGE BONILLA: I have to ask, who has a bird?
`MS. STERLING: Not I, Your Honor. You have to ask the
`obviousness question from the perspective of a person of ordinary skill in
`the art who is aware of all pertinent art. We took issue with the fact that Dr.
`Carroll and Dr. Katznelson looked at the label, admittedly, in isolation from
`Lee, and they did not consider the perspective of what a person of ordinary
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`skill in the art, of drug-drug interactions, or pharmacokineticists would be
`doing with this invention and the -- or with the instructions in Lee.
`Your Honor, we've represented their --
`JUDGE COTTA: Counsel, if I could interrupt again with a question.
`One of the concerns I have with the -- the definition that, at least as written,
`seems to propose three alternative different POSAs, what would you have us
`do if we determine that the invention might have been obvious to one of
`those POSAs, but not another of the POSAs?
`MS. STERLING: Then it would have been obvious to a person of
`ordinary skill in the art, Your Honor.
`JUDGE COTTA: Is there any federal circuit precedent to support
`that or is this a unique situation?
`MS. STERLING: Your Honor, I'm blanking on the name of the
`case, but I know there are -- there's case law that says if there are more than
`one obvious things out there, right, if you could arrive at more than one
`obvious end result, it doesn't make any one or -- one of them more obvious
`than the other one or less obvious than the other one, I feel like that is
`analogous here, right?
`If a person of ordinary skill in the art finds this invention obvious,
`then the invention's obvious.
`JUDGE COTTA: So if any person of skill in the art would find it
`obvious, then it's obvious, is that the -- that's your position.
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`MS. STERLING: As long as they're a person of ordinary skill in the
`art, approaching the -- reading the art as a whole, yes. We fault Dr. Carroll
`and Dr. Katznelson for doing that. Now, would a physician sitting in their
`office with only the Korlym label in their hand have stuck with the 300mg
`limitation in the label? Very likely, yes. But that's not the art as a whole
`there, Your Honor.
`JUDGE BONILLA: And your position that -- so if we follow-up
`with that, so the person who's only an expert in drug-drug interactions, that's
`a person of ordinary skill in the art, and your position that even that person
`would find it obvious, notwithstanding the statements in Lee that say that
`there's a significant safety risk, and so on.
`I think what you're saying at that point is that it would've, for a drug-
`drug interaction person, it would have been routine optimization to go
`beyond that. My thing that I'm stuck on is, even assuming that's true, why
`would they have a reasonable expectation of success when they haven't done
`it yet?
`
`Because at that point, all they're reading is Lee, and Lee tells them
`that it's a significant safety risk.
`MS. STERLING: Okay. So, let's break that down. Yes, Your
`Honor, with a drug-drug interaction study person looking at Lee, they would
`have had the motivation to go and test the other doses. And I believe you're
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`asking then, would they have had a reasonable expectation of success, given
`the caution in Lee, as to the safety aspect of this drug-drug interaction.
`If that's the correct understanding of your question, Your Honor, as
`Dr. Greenblatt and the petition explains, first off, it's not true that one would
`expect an increase in exposure of 17 to 20-fold, or 7 to 20-fold, for example.
`Dr. Greenblatt tells us in his declaration that you would expect
`anything from a few percentage increase, few percentage points, up to,
`possibly, 15 or 20-fold, right?
`So within that realm, there's a range of outcomes. We know that the
`FDA has considered 300mg with ketoconazole is safe because they put that
`instruction in the label. So the next obvious dose to try, as even Dr.
`Katznelson, Corcept's own expert, says, would be 600.
`Now, why would a person of ordinary skill in the art be okay with
`doing that? Well, the art tells us that in monotherapy, mifepristone was used
`for Cushing's patients, the label itself said, up to 1200mg, and there are other
`references in the record that say up to 2000mg of mifepristone was used to
`treat --
`JUDGE COTTA: Counsel, one concern I have with that argument is
`reconciling that with the -- with Dr. Greenblatt's deposition testimony, which
`is featured prominently in Patent Owner's briefing, about what the
`expectation would be with respect to adverse events when mifepristone is
`administered together with ketoconazole. Could you address that, please?
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`MS. STERLING: Yes, I can. Your Honor, that testimony was -- Dr.
`Greenblatt was being asked about specific outcomes. And his testimony has
`been clear since the start of this proceeding that you do not have an a priori
`expectation of exactly what outcome you're going to get.
`So the being, he's knows that you're going to end up with an increase
`in exposure, between a few percentage points, up to, possibly, 20-fold. The
`art gives you the safe range of monotherapy for mifepristone, which goes up
`to 2000mg, and within that, and knowing that the majority of the drug-drug
`interactions end up at fivefold, or much lower, there's evidence to that in the
`record, Your Honor, person of ordinary skill in the art would have had a
`reasonable expectation that 600mg would be safe.
`Now, would they have had an absolute predictability? No, and that's
`what that line of questioning goes to, it's asking specifically, would have
`expected this, would you have expected that? And Dr. Greenblatt --
`JUDGE POLLOCK: Counsel?
`MS. STERLING: -- has been clear that you have no expectations.
`JUDGE POLLOCK: You need to establish --
`MS. STERLING: But that's different from a --
`JUDGE POLLOCK: Am I on mute? No. All right. Counsel
`Sterling, you need to establish a reasonable expectation of success. Would
`you define what success is in this case? Is it pharmokinetic, is it safety, is it
`merely efficacy?
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`MS. STERLING: Your Honor, we would say it is efficacy, as we
`pointed out in reply, based on the safety arguments that Corcept kept
`presenting, the claims have no requirement of safety here. Dr. Greenblatt
`and the petition itself, the petition at, I believe it's Page 31, asks the question,
`oh, it was Dr. Greenblatt, sorry, at Paragraph 61, he asks the question, you
`know, the question here, would you reasonably expect that Korlym,
`mifepristone, and ketoconazole could be administered to Cushing's patients
`at some dose? Yes, he would reasonably expect to arrive at that based on
`what was known in the art. That's his reasonable expectation of success here.
`As to the safety arguments that Corcept makes on reply, the claims
`don't require safety, Your Honor. There's no mention of that.
`JUDGE BONILLA: But it's a method of treatment of a patient,
`correct? Does it give some level of the method --
`JUDGE POLLOCK: To some level of which -- I'm sorry. Please go
`
`ahead.
`
`JUDGE BONILLA: I apologize. Can you all hear me? I was
`worried I blocked out. Should we be concerned about it's a method of
`treatment in the patient, so whether one would have reasonably expected
`success -- I mean, safety and efficacy matter when you're actually treating a
`patient. Should we be concerned about the fact that it has to go into a
`patient?
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`We shouldn't -- the reasonable expectation of success should include
`whether the thing would cause major toxicity, for example.
`MS. STERLING: Your Honor, yes, and that's the question -- well,
`these claims don't have any safety requirements. The definition of treatment
`in the specification does not have any safety requirements at all. And there
`are other cases where that has been important with regards to arguments in
`defense of a patent.
`Your Honor, in this case, the question is, not -- the law does not
`require absolute certainty that 600mg is going to be safe and effective. The
`drug-drug interaction study will show what the safe and effective dose is.
`Dr. Greenblatt said you'd have a reasonable expectation --
`JUDGE POLLOCK: I've lost --
`JUDGE BONILLA: She's frozen for me. Yes.
`JUDGE POLLOCK: -- Counsel Sterling. She's frozen mid-answer.
`So excuse me, Counsel? Counsel, you froze mid-answer, at least for us.
`JUDGE BONILLA: Do you mind repeating your answer?
`JUDGE COTTA: Or would you rather have the court reporter read
`back where -- what you last said?
`MS. STERLING: That would be helpful if the court reporter could
`read it back, then I could pick up from
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