Deposition of:
`Adrian Dobs , M.D.
`
`June 24, 2020
`
`In the Matter of:
`Corcept Therapeutics v. Teva
`Pharmaceuticals
`
`Veritext Legal Solutions
`800-734-5292 | calendar-dmv@veritext.com |
`
`Teva Pharmaceuticals USA, Inc. v. Corcept Therapeutics, Inc.
`PGR2019-00048
`Corcept Ex. 2071, Page 1
`
`
`Adrian Dobs , M.D.
`
`June 24, 2020
`
`In the Matter of:
`Corcept Therapeutics v. Teva
`Pharmaceuticals
`
`Veritext Legal Solutions
`800-734-5292 | calendar-dmv@veritext.com |
`
`Teva Pharmaceuticals USA, Inc. v. Corcept Therapeutics, Inc.
`PGR2019-00048
`Corcept Ex. 2071, Page 1
`
`
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`Page 1
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` UNITED STATES PATENT AND TRADEMARK OFFICE
`
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
` ----------------------------------- )
`
` TEVA PHARMACEUTICALS USA, INC. )
`
` Petitioner )PGR No.
`
` vs. )2019-00048
`
` CORCEPT THERAPEUTICS, INC. )
`
` Patent Owner )
`
` ----------------------------------- )
`
` DEPOSITION OF ADRIAN DOBS, M.D.
`
` APPEARING REMOTELY FROM WASHINGTON, D.C.
`
` June 24, 2020
`
` REPORTED BY: Tina Alfaro, RPR, CRR, RMR
`
`Veritext Legal Solutions
`215-241-1000 ~ 610-434-8588 ~ 302-571-0510 ~ 202-803-8830
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`Teva Pharmaceuticals USA, Inc. v. Corcept Therapeutics, Inc.
`PGR2019-00048
`Corcept Ex. 2071, Page 2
`
`
`
`Page 2
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` June 24, 2020
`
` 9:00 a.m.
`
` Videotaped deposition of ADRIAN DOBS, M.D.
`
` taken remotely before Tina M. Alfaro, a Notary
`
` Public within and for the District of Columbia.
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`Veritext Legal Solutions
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`
`Teva Pharmaceuticals USA, Inc. v. Corcept Therapeutics, Inc.
`PGR2019-00048
`Corcept Ex. 2071, Page 3
`
`
`
`Page 3
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` A P P E A R A N C E S : ( V i a Z o o m )
`
` O N B E H A L F O F T E V A P H A R M A C E U T I C A L S U S A :
`
` S T E R N E K E S S L E R G O L D S T E I N & F O X , P L L C
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` B Y : D E B O R A H S T E R L I N G , E S Q .
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` 1 1 0 0 N e w Y o r k A v e n u e , N W , 6 t h F l o o r
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` W a s h i n g t o n , D . C . 2 0 0 0 5
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` ( 2 0 2 ) 3 7 1 - 2 6 0 0
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` O N B E H A L F O F T H E P A T E N T O W N E R :
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` Q U I N N E M A N U E L U R Q U H A R T & S U L L I V A N , L L P
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` B Y : E R I C S T O P S , E S Q .
`
` 5 1 M a d i s o n A v e n u e , 2 2 n d F l o o r
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` N e w Y o r k , N e w Y o r k 1 0 0 1 0
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` ( 2 1 2 ) 8 4 9 - 1 0 0 0
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`Veritext Legal Solutions
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`Teva Pharmaceuticals USA, Inc. v. Corcept Therapeutics, Inc.
`PGR2019-00048
`Corcept Ex. 2071, Page 4
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`Page 4
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` I N D E X
`
` EXAMINATION
`
` WITNESS PAGE
`
` ADRIAN DOBS, M.D.
`
` By Mr. Stops 5
`
` PREVIOUSLY MARKED EXHIBITS
`
` TEVA EXHIBITS DESCRIPTION MARKED
`
` Exhibit 1001 214 Patent 20
`
` Exhibit 1004 2012 Korlym label 13
`
` Exhibit 1005 Lee publication 109
`
` Exhibit 1006 FDA approval letter 140
`
` Exhibit 1016 Heikinheimo publication 72
`
` Exhibit 1065 Drug approval package 122
`
` Exhibit 1068 Declaration 7
`
` CORCEPT EXHIBITS DESCRIPTION MARKED
`
` Exhibit 2012 Fleseriu article 148
`
` Exhibit 2052 Greenblatt publication 88
`
` Exhibit 2055 "Cross-discipline team 110
`
` review"
`
` Exhibit 2063 FDA advisory 76
`
` Exhibit 2069 Medical review portion 125
`
` of drug approval package
`
`Veritext Legal Solutions
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`Teva Pharmaceuticals USA, Inc. v. Corcept Therapeutics, Inc.
`PGR2019-00048
`Corcept Ex. 2071, Page 5
`
`
`
`Page 5
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` (Witness sworn.)
`
` WHEREUPON:
`
` ADRIAN DOBS, M.D.,
`
` called as a witness herein, having been first duly
`
` sworn, was examined and testified as follows:
`
` EXAMINATION
`
` BY MR. STOPS:
`
` Q. Good morning, again, Dr. Dobs. My name's
`
` Eric Stops. I'm going to be asking you some
`
` questions this morning.
`
` You've been deposed before, correct?
`
` A. Yes, sir.
`
` Q. Approximately how many times?
`
` A. Five times.
`
` Q. Have any of your prior depositions been
`
` remote?
`
` A. No.
`
` Q. Now, you're appearing today in this
`
` proceeding on behalf of Teva, correct?
`
` A. Correct.
`
` Q. And where are you physically located this
`
` morning?
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`Veritext Legal Solutions
`215-241-1000 ~ 610-434-8588 ~ 302-571-0510 ~ 202-803-8830
`
`Teva Pharmaceuticals USA, Inc. v. Corcept Therapeutics, Inc.
`PGR2019-00048
`Corcept Ex. 2071, Page 6
`
`
`
`Page 6
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` A. I'm in Baltimore, Maryland.
`
` Q. And is anyone involved in this matter
`
` physically present with you this morning?
`
` A. No.
`
` Q. Now, you received a box of paper documents
`
` from us for use in your deposition today, correct?
`
` A. Yes.
`
` Q. And you have that box with you?
`
` A. Yes.
`
` Q. Just for verification, the box -- the
`
` folders in the box have numbers on them, correct?
`
` A. Yes.
`
` Q. Just for your information, those numbers
`
` are the exhibit numbers that the parties are using
`
` in this PGR proceeding. So I'll be referring to
`
` the documents by their exhibit number.
`
` A. Okay.
`
` Q. And you have not written on, highlighted,
`
` flagged, or otherwise marked up the documents in
`
` the box, correct?
`
` A. Correct.
`
` Q. Okay. For the deposition today I'd ask
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`Veritext Legal Solutions
`215-241-1000 ~ 610-434-8588 ~ 302-571-0510 ~ 202-803-8830
`
`Teva Pharmaceuticals USA, Inc. v. Corcept Therapeutics, Inc.
`PGR2019-00048
`Corcept Ex. 2071, Page 7
`
`
`
`Page 7
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` that you use the -- either the clean copies of the
`
` documents that you have in the box or the
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` electronic versions that will be marked through the
`
` Veritext system. Is that okay?
`
` A. Yes.
`
` Q. So to the extent you have any other
`
` marked-up copies of documents, notes, or other
`
` materials relating to this matter, please put those
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` aside for the duration of the deposition. Okay?
`
` A. Okay.
`
` Q. Now, you've submitted one declaration in
`
` this proceeding, correct?
`
` A. Yes.
`
` Q. And I've moved a copy of Exhibit 1068,
`
` which is your declaration, into the Veritext
`
` system. You see that, correct?
`
` A. Yes.
`
` Q. Have you prepared any documents for this
`
` action beyond your declaration?
`
` A. No.
`
` Q. You're familiar with the drug product
`
` dexamethasone, correct?
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`Veritext Legal Solutions
`215-241-1000 ~ 610-434-8588 ~ 302-571-0510 ~ 202-803-8830
`
`Teva Pharmaceuticals USA, Inc. v. Corcept Therapeutics, Inc.
`PGR2019-00048
`Corcept Ex. 2071, Page 8
`
`
`
`Page 8
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` A. Yes.
`
` Q. And you've prescribed dexamethasone in the
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` past, correct?
`
` MS. STERLING: Objection to relevance.
`
` A. Yes.
`
` Q. Dexamethasone is considered a steroid,
`
` correct?
`
` MS. STERLING: Objection, scope.
`
` A. Well, it is a glucocorticoid.
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` Q. Are you familiar with the chemical
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` structure of dexamethasone?
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` MS. STERLING: Objection, relevance.
`
` A. Loosely.
`
` Q. It's related to the structure of
`
` hydrocortisone, correct?
`
` MS. STERLING: Objection, scope.
`
` A. Yes, it's chemically related.
`
` Q. Dexamethasone binds to the glucocorticoid
`
` receptor, correct?
`
` MS. STERLING: Objection, scope.
`
` A. Yes.
`
` Q. And it's considered to be a glucocorticoid
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`Veritext Legal Solutions
`215-241-1000 ~ 610-434-8588 ~ 302-571-0510 ~ 202-803-8830
`
`Teva Pharmaceuticals USA, Inc. v. Corcept Therapeutics, Inc.
`PGR2019-00048
`Corcept Ex. 2071, Page 9
`
`
`
`Page 9
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` receptor agonist, correct?
`
` MS. STERLING: Objection, scope.
`
` A. Yes.
`
` Q. What does it mean that it is an agonist of
`
` the glucocorticoid receptor?
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` MS. STERLING: Objection, scope.
`
` A. It means that it attaches to the
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` glucocorticoid receptor and the receptor turns on a
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` whole process of steps towards action.
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` Q. So it is something that activates or turns
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` on the receptor, correct?
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` MS. STERLING: Objection, form, scope.
`
` A. Yes.
`
` Q. The opposite of an agonist is an
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` antagonist, correct?
`
` MS. STERLING: Objection, form, scope.
`
` A. Yes.
`
` Q. So something that is a glucocorticoid
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` receptor antagonist binds to the receptor and turns
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` it off, correct?
`
` MS. STERLING: Objection, scope, form.
`
` A. It allows it not to be stimulated.
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`Veritext Legal Solutions
`215-241-1000 ~ 610-434-8588 ~ 302-571-0510 ~ 202-803-8830
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`Teva Pharmaceuticals USA, Inc. v. Corcept Therapeutics, Inc.
`PGR2019-00048
`Corcept Ex. 2071, Page 10
`
`
`
`Page 10
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` Q. Depending on the mechanism of inhibition,
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` I guess, it would depend, right?
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` MS. STERLING: Objection, form, scope.
`
` A. Yes.
`
` Q. And mifepristone is an example of a
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` glucocorticoid receptor antagonist, correct?
`
` A. Yes.
`
` Q. Give me one moment. I just have to
`
` re-adjust my windows on the computer.
`
` I guess to use a simple analogy, giving a
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` glucocorticoid receptor agonist is like stepping on
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` the gas pedal for the glucocorticoid receptor?
`
` MS. STERLING: Objection, form, scope.
`
` MR. STOPS: I'm sorry, Doctor, I don't
`
` think we got your answer.
`
` A. Yes.
`
` Q. And giving a glucocorticoid receptor
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` antagonist would be equivalent to stepping on the
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` break pedal for the glucocorticoid receptor,
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` correct?
`
` MS. STERLING: Objection, form, scope.
`
` A. Yes.
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`Veritext Legal Solutions
`215-241-1000 ~ 610-434-8588 ~ 302-571-0510 ~ 202-803-8830
`
`Teva Pharmaceuticals USA, Inc. v. Corcept Therapeutics, Inc.
`PGR2019-00048
`Corcept Ex. 2071, Page 11
`
`
`
`Page 11
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` Q. So giving both a glucocorticoid receptor
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` agonist and antagonist at the same time would be
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` like stepping on the gas pedal and the break pedal
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` simultaneously, correct?
`
` MS. STERLING: Objection, form, scope.
`
` A. Yes. It would depend on the strength of
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` each separately.
`
` Q. And a glucocorticoid receptor agonist can
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` be used to counteract the effects of a
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` glucocorticoid receptor antagonist, correct?
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` MS. STERLING: Objection, scope, form.
`
` A. Yes.
`
` Q. Prednisone is another glucocorticoid,
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` right?
`
` MS. STERLING: Objection, form, scope.
`
` A. Yes.
`
` Q. And it is also considered to be a
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` glucocorticoid receptor agonist, correct?
`
` MS. STERLING: Objection, form, scope,
`
` foundation.
`
` A. Yes.
`
` Q. Hydrocortisone is also a glucocorticoid,
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`Veritext Legal Solutions
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`Teva Pharmaceuticals USA, Inc. v. Corcept Therapeutics, Inc.
`PGR2019-00048
`Corcept Ex. 2071, Page 12
`
`
`
`Page 12
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` correct?
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` MS. STERLING: Objection, form, scope.
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` A. Yes.
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` Q. And hydrocortisone is also a
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` glucocorticoid receptor agonist, correct?
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` MS. STERLING: Objection, form, scope.
`
` A. Yes.
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` Q. And hydrocortisone can counteract the
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` effects of glucocorticoid receptor antagonists such
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` as mifepristone, correct?
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` MS. STERLING: Objection, form, scope,
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` foundation.
`
` A. Yes.
`
` Q. Now, a potential side effect of
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` mifepristone administration is adrenal
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` insufficiency, correct?
`
` MS. STERLING: Objection, form.
`
` A. Yes, it could happen.
`
` Q. Okay. And the treatment for adrenal
`
` insufficiency is to administer glucocorticoids,
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` correct?
`
` MS. STERLING: Objection, form,
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`Veritext Legal Solutions
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`Teva Pharmaceuticals USA, Inc. v. Corcept Therapeutics, Inc.
`PGR2019-00048
`Corcept Ex. 2071, Page 13
`
`
`
`Page 13
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` foundation.
`
` A. Yes.
`
` Q. I am going to move a copy of the 2012
`
` Korlym label into the marked exhibits. Dr. Dobs,
`
` will you confirm that Exhibit 1004, which is the
`
` 2012 Korlym label, is available to you in the
`
` marked exhibits?
`
` A. Hold on one second. I think I might have
`
` gotten --
`
` MR. STOPS: Tina, we can pause for one
`
` second as we figure out this issue.
`
` (A short break was had.)
`
` BY MR. STOPS:
`
` Q. Dr. Dobs, you can now access Exhibit 1004,
`
` the Korlym label; is that right?
`
` A. Yes.
`
` Q. Feel free to use either the paper version
`
` of any document I refer to today or the electronic
`
` version.
`
` A. Okay.
`
` Q. Is there -- do you feel more comfortable
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` with paper or electronic?
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`Veritext Legal Solutions
`215-241-1000 ~ 610-434-8588 ~ 302-571-0510 ~ 202-803-8830
`
`Teva Pharmaceuticals USA, Inc. v. Corcept Therapeutics, Inc.
`PGR2019-00048
`Corcept Ex. 2071, Page 14
`
`
`
`Page 14
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` A. Well I think we'll just stick to
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` electronic.
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` Q. Okay. Let's give it a shot.
`
` If you open up Exhibit 1004, would you
`
` confirm that you recognize this document to be the
`
` 2012 Korlym package insert?
`
` A. Yes.
`
` Q. Would you turn to page 5 of Exhibit 1004.
`
` A. I am on page 5 of the document.
`
` Q. At the top of the page it states "Warnings
`
` and Precautions"; is that correct?
`
` A. Yes.
`
` Q. And underneath that is a section 5.1
`
` labeled "Adrenal Insufficiency"; is that right?
`
` A. Yes.
`
` Q. Now, about five lines down under the
`
` "Adrenal Insufficiency" heading there is a line
`
` that states "If adrenal insufficiency is suspected,
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` discontinue treatment with Korlym immediately and
`
` administer glucocorticoids without delay," correct?
`
` MS. STERLING: Objection, scope.
`
` A. Correct.
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`Veritext Legal Solutions
`215-241-1000 ~ 610-434-8588 ~ 302-571-0510 ~ 202-803-8830
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`Teva Pharmaceuticals USA, Inc. v. Corcept Therapeutics, Inc.
`PGR2019-00048
`Corcept Ex. 2071, Page 15
`
`
`
`Page 15
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` Q. And the reason that the label instructs
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` the administration of glucocorticoids if adrenal
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` insufficiency is suspected is because the
`
` glucocorticoids reverse the effects of
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` mifepristone, correct?
`
` MS. STERLING: Objection, scope.
`
` A. Correct.
`
` Q. We're going to switch over to your
`
` declaration for a moment, and, again, there's --
`
` it's either available to you in the folder on-line
`
` or a paper copy in your box.
`
` Now, in paragraph 15 of your declaration
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` you list a series of materials that you considered
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` in drafting your declaration, correct?
`
` A. Correct.
`
` Q. Other than the materials that you set
`
` forth in Exhibit 15 and in your declaration, you
`
` didn't review any other materials in preparing your
`
` declaration, correct?
`
` A. There was nothing I reviewed that was
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` specific to mifepristone.
`
` Q. Just so I'm clear, are you saying you
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`Teva Pharmaceuticals USA, Inc. v. Corcept Therapeutics, Inc.
`PGR2019-00048
`Corcept Ex. 2071, Page 16
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`Page 16
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` reviewed other material, but it wasn't specific to
`
` mifepristone?
`
` MS. STERLING: I'm going to object to the
`
` extent this gets to privilege. Dr. Dobs, you can
`
` talk generally about what you reviewed, but please
`
` don't discuss any of the confidential conversations
`
` you had with counsel.
`
` A. It was just generally some information on
`
` CYP inhibitors in general just to remind myself of
`
` some scientific issues.
`
` Q. Okay. And this was in preparing your
`
` declaration?
`
` A. It was more background in the very
`
` beginning.
`
` Q. Okay. Anything specific that you feel
`
` should be added to your list of materials
`
` considered here?
`
` A. No.
`
` Q. Okay.
`
` Did you do any -- let me just ask a
`
` general question on this. Well, first, the
`
` materials that are set forth in your paragraph 15,
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`Teva Pharmaceuticals USA, Inc. v. Corcept Therapeutics, Inc.
`PGR2019-00048
`Corcept Ex. 2071, Page 17
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`Page 17
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` those were all provided to you by counsel, correct?
`
` A. Correct.
`
` Q. Now, other than familiarizing yourself
`
` with background on CYP inhibitors, did you do any
`
` independent searching on your own?
`
` MS. STERLING: Objection, form.
`
` A. No.
`
` Q. Okay. You didn't do any searching for
`
` documents concerning the co-administration of
`
` mifepristone and any other substances, correct?
`
` MS. STERLING: Objection, form.
`
` A. Correct.
`
` Q. And you did not review the declaration of
`
` Dr. Gingrich that was submitted on behalf of
`
` Corcept, correct?
`
` A. I thought I did.
`
` Q. It seems -- it looks from the -- your
`
` paragraph 15 that you reviewed a declaration of
`
` Dr. David Greenblatt, which is Exhibit 1002.
`
` A. Yes.
`
` Q. Which was submitted on behalf of Teva and
`
` you submitted -- sorry -- you reviewed the
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`Teva Pharmaceuticals USA, Inc. v. Corcept Therapeutics, Inc.
`PGR2019-00048
`Corcept Ex. 2071, Page 18
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`
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`Page 18
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` declaration of Ty Carroll and Laurence Katznelson,
`
` which are Exhibits 2057 and 2058, but I don't see a
`
` declaration of Dr. Gingrich on this list.
`
` MS. STERLING: Objection, form.
`
` MR. STOPS: So I guess my question is --
`
` well, are you familiar with Dr. Peter Gingrich?
`
` A. I'm not.
`
` Q. Okay. And had you -- if you had reviewed
`
` his declaration, it would be on the list in
`
` paragraph 15, correct?
`
` A. I did review it, and it was my error that
`
` I didn't pick it up. I did review this article --
`
` this document.
`
` Q. Okay. Do you recall the subject matter of
`
` the Gingrich declaration?
`
` A. Well, the subject matter was related to
`
` what we're talking about, but right now I cannot
`
` recall the specifics of what was -- what was
`
` stated.
`
` Q. Okay. So I assume that since it's not
`
` mentioned elsewhere in your declaration, you've not
`
` formulated any opinions relating to it?
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`Veritext Legal Solutions
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`Teva Pharmaceuticals USA, Inc. v. Corcept Therapeutics, Inc.
`PGR2019-00048
`Corcept Ex. 2071, Page 19
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`
`
` A. Correct.
`
` Q. Okay. Anything else listed in here today
`
` that you may have reviewed that's not listed in
`
`Page 19
`
` your paragraph 15?
`
` A. Nothing else.
`
` Q. Now, the declarations of Drs. Greenblatt,
`
` Carroll, and Katznelson also cite a number of
`
` references in the declarations themselves. You did
`
` not review those, correct?
`
` MS. STERLING: Objection, foundation,
`
` form.
`
` A. Correct.
`
` Q. Did you ask for any of the references
`
` cited in the declarations based on your review?
`
` MS. STERLING: Objection, foundation,
`
` form.
`
` A. No.
`
` MS. STERLING: And we're getting close to
`
` privileged conversations here, Eric.
`
` BY MR. STOPS:
`
` Q. Did you know that all of the declarants --
`
` I'll start that again. Were you aware that all the
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`Veritext Legal Solutions
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`
`Teva Pharmaceuticals USA, Inc. v. Corcept Therapeutics, Inc.
`PGR2019-00048
`Corcept Ex. 2071, Page 20
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`
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`Page 20
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` individuals who submitted declarations in this
`
` action were also deposed?
`
` MS. STERLING: Objection, form, relevance.
`
` A. I don't know that.
`
` Q. You did not review the deposition
`
` transcripts of any of the declarants, correct?
`
` A. Correct.
`
` Q. Okay. Let's go to the patent itself.
`
` I'll move a copy of that into the folder. I have
`
` moved Exhibit 1001, which is the '214 Patent,
`
` into the folder. Can you confirm that you can
`
` access that?
`
` A. I don't see it yet. Okay. 1001, yes.
`
` Q. And you recognize this Exhibit 1001 to be
`
` the '214 Patent, correct?
`
` A. Yes.
`
` Q. And you reviewed the '214 Patent in
`
` formulating your opinions for this action, correct?
`
` A. Yes.
`
` Q. Were you aware of the '214 Patent prior to
`
` your involvement in this proceeding?
`
` A. No.
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`Veritext Legal Solutions
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`
`Teva Pharmaceuticals USA, Inc. v. Corcept Therapeutics, Inc.
`PGR2019-00048
`Corcept Ex. 2071, Page 21
`
`
`
` Q. Now, the inventor on the '214 Patent is
`
`Page 21
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` Joseph Belanoff; do you see that?
`
` A. Yes.
`
` Q. Do you know Dr. Belanoff?
`
` A. No.
`
` Q. The title of the '214 Patent is the
`
` "Concomitant administration of glucocorticoid
`
` receptor modulators and CYP3A inhibitors"; do you
`
` see that?
`
` A. Yes.
`
` Q. What does that title mean to you?
`
` MS. STERLING: Objection, form, relevance,
`
` scope.
`
` A. This means that this is -- so, again, this
`
` is 2019, the date of this patent, and it means that
`
` a patent -- this patent relates to the
`
` administration of both a glucocorticoid receptor
`
` and a CYP3A inhibitor.
`
` Q. Okay. On the bottom right of the first
`
` page there's a section entitled "Abstract"; do you
`
` see that?
`
` A. Yes.
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`Veritext Legal Solutions
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`
`Teva Pharmaceuticals USA, Inc. v. Corcept Therapeutics, Inc.
`PGR2019-00048
`Corcept Ex. 2071, Page 22
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`
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`Page 22
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` Q. And you understand the abstract of a
`
` patent to be essentially a summary of the
`
` invention, correct?
`
` MS. STERLING: Objection, scope,
`
` relevance, form.
`
` A. Correct.
`
` Q. And the first sentence of the abstract
`
` states that the invention is "Methods of treating
`
` diseases including Cushing's Syndrome and hormone-
`
` sensitive cancers by concomitant administration of
`
` a glucocorticoid receptor antagonist and
`
` steroidogenesis inhibitors and by concomitant
`
` administration of a GRA and CYP3A inhibitors,"
`
` right?
`
` A. Correct, that's what it says.
`
` Q. And about halfway down -- I'm sorry.
`
` About halfway down the abstract it explains the
`
` discovery underlying the patent as "Applicant has
`
` surprisingly found that GRA's may be administered
`
` to subjects receiving CYP3A inhibitors or
`
` steroidogenesis inhibitors such as ketoconazole
`
` without increasing risk adverse events -- sorry --
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`Veritext Legal Solutions
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`
`Teva Pharmaceuticals USA, Inc. v. Corcept Therapeutics, Inc.
`PGR2019-00048
`Corcept Ex. 2071, Page 23
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`
`
`Page 23
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` adverse reactions"; do you see that?
`
` A. Yes.
`
` MS. STERLING: Objection, form.
`
` Q. Mifepristone is a GRA, correct?
`
` A. Yes.
`
` Q. And right after that section the abstract
`
` explains that "Applicant has found that
`
` mifepristone may be concomitantly administered with
`
` ketoconazole (a CYP3A inhibitor and a
`
` steroidogenesis inhibitor) providing safe
`
` concomitant administration of the GRA and
`
` ketoconazol," right?
`
` MS. STERLING: Objection, form, document
`
` speaks for itself.
`
` A. It does say that.
`
` Q. So the inventions in the patent are about
`
` the surprising discovery that mifepristone could be
`
` safely co-administered with CYP3A inhibitors or
`
` steroidogenesis inhibitors, correct?
`
` MS. STERLING: Objection, form.
`
` A. It does say that, although the word
`
` "surprising" is not clear or surprising to me when
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`Veritext Legal Solutions
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`
`Teva Pharmaceuticals USA, Inc. v. Corcept Therapeutics, Inc.
`PGR2019-00048
`Corcept Ex. 2071, Page 24
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`
`
`Page 24
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` I looked at.
`
` Q. You're aware that ketoconazole has
`
` potentially serious adverse effects, right?
`
` MS. STERLING: Objection, form.
`
` A. Yes.
`
` Q. And you're aware that Korlym was approved
`
` by the FDA in 2012, correct?
`
` MS. STERLING: Objection, form.
`
` A. Yes.
`
` Q. Would you turn to column 2 of the
`
` '214 Patent and I'll direct you to about line 43.
`
` A. I'm sorry. Could you repeat again? This
`
` is in --
`
` Q. Same document you're looking at right now.
`
` A. Okay. And what page?
`
` Q. So the number on the bottom of the page is
`
` 4, but it's column 2. The column headings are on
`
` the top.
`
` A. Okay.
`
` Q. And then in the middle of each page of the
`
` patent there is line numbering.
`
` A. Yes.
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`Veritext Legal Solutions
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`
`Teva Pharmaceuticals USA, Inc. v. Corcept Therapeutics, Inc.
`PGR2019-00048
`Corcept Ex. 2071, Page 25
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`
`
`Page 25
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` Q. So column 2, line 43.
`
` A. Okay.
`
` Q. There is the sentence -- sorry. Do you
`
` see the sentence that reads "The U.S. Food and Drug
`
` Administration issued a drug safety communication
`
` (July 26, 2013 safety announcement regarding
`
` Nizoral (ketoconazole)) warning of potentially
`
` fatal liver damage associated with oral
`
` ketoconazole treatment and warning of the risk of
`
` adrenal insufficiency, also a potentially fatal
`
` disorder," correct?
`
` MS. STERLING: Objection, scope.
`
` A. I see that that is stated -- that it is
`
` written here that this is a warning.
`
` Q. Okay.
`
` Now, that 2013 FDA safety communication
`
` concerning ketoconazole was issued after Korlym was
`
` approved, correct?
`
` MS. STERLING: Objection, scope.
`
` A. Yes.
`
` Q. And just so we're clear, the drug product
`
` Nizoral is the brand name for ketoconazole,
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`Veritext Legal Solutions
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`
`Teva Pharmaceuticals USA, Inc. v. Corcept Therapeutics, Inc.
`PGR2019-00048
`Corcept Ex. 2071, Page 26
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`
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`Page 26
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` correct?
`
` MS. STERLING: Objection, scope.
`
` A. Correct.
`
` Q. Are you familiar with the 2013 safety
`
` communication regarding ketoconazole?
`
` MS. STERLING: Objection, scope.
`
` A. Yes.
`
` Q. Now, adrenal insufficiency you agree is a
`
` potentially fatal disorder, correct?
`
` MS. STERLING: Objection, form,
`
` foundation.
`
` A. Adrenal insufficiency can be in very
`
` severe cases a life threatening disorder.
`
` Q. And adrenal insufficiency is also a
`
` potential side effect of mifepristone
`
` administration, correct?
`
` MS. STERLING: Objection, form, scope.
`
` A. Yes, it can be.
`
` Q. And the 2013 safety announcement
`
` concerning ketoconazole warned that ketoconazole
`
` can cause liver injury which can also -- which may
`
` potentially result in liver transplantation or
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`Veritext Legal Solutions
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`Teva Pharmaceuticals USA, Inc. v. Corcept Therapeutics, Inc.
`PGR2019-00048
`Corcept Ex. 2071, Page 27
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`
`
`Page 27
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` death, correct?
`
` MS. STERLING: Objection, foundation,
`
` form.
`
` A. Ketoconazole has pretty much long been
`
` known as causing abnormal liver function tests,
`
` liver abnormalities, liver transplant, and death.
`
` Ketoconazole has been known for that.
`
` Q. And that was part of the 2013 safety
`
` announcement, correct?
`
` MS. STERLING: Objection, foundation,
`
` form.
`
` A. It has been known for really quite some
`
` time independent of this discussion that
`
` ketoconazole is associated with liver -- can be
`
` associated with liver failure.
`
` Q. But that was also -- as it states in the
`
` patent, the safety announcement included that
`
` information in the -- in 2013 as well, correct?
`
` MS. STERLING: Objection, foundation,
`
` scope, form.
`
` A. So in this patent it does state that
`
` ketoconazole can cause liver injury, transplant, or
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`Veritext Legal Solutions
`215-241-1000 ~ 610-434-8588 ~ 302-571-0510 ~ 202-803-8830
`
`Teva Pharmaceuticals USA, Inc. v. Corcept Therapeutics, Inc.
`PGR2019-00048
`Corcept Ex. 2071, Page 28
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`
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`Page 28
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` death. That's true.
`
` Q. Okay.
`
` Now, would you turn to the -- I guess it's
`
` the second-to-last page of the patent. It's
`
` column 68 that includes the claims of the patent.
`
` A. Okay. I'm at column 68.
`
` Q. Do you see the top states "The invention
`
` claimed is"?
`
` A. Yes.
`
` Q. And you understand that what follows are
`
` the claims of the patent?
`
` A. Correct.
`
` Q. And the claims of the '214 Patent are
`
` methods of treating patients, correct?
`
` MS. STERLING: Objection to the extent it
`
` calls for a legal conclusion.
`
` A. Can you repeat that question again,
`
` please.
`
` Q. Sure.
`
` The claims of this patent, the '214 Patent
`
` are methods of treating patients, correct?
`
` MS. STERLING: Objection to the extent it
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`Veritext Legal Solutions
`215-241-1000 ~ 610-434-8588 ~ 302-571-0510 ~ 202-803-8830
`
`Teva Pharmaceuticals USA, Inc. v. Corcept Therapeutics, Inc.
`PGR2019-00048
`Corcept Ex. 2071, Page 29
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`
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`Page 29
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` calls for a legal conclusion.
`
` A. Yes.
`
` Q. Okay. And specifically they are methods
`
` of treating patients with mifepristone, correct?
`
` MS. STERLING: Same objection.
`
` A. Yes.
`
` Q. And claim 1 is a method of treating
`
` Cushing's Syndrome in a patient who is taking
`
` mifepristone, correct?
`
` MS. STERLING: Objection, form and to the
`
` extent it calls for a legal conclusion.
`
` A. Yes.
`
` Q. Now, these claims concern clinical
`
` practice, correct?
`
` MS. STERLING: Objection, form.
`
` A. Yes.
`
` Q. Who would perform these claims?
`
` MS. STERLING: Objection, form, scope.
`
` A. An endocrinologist is the usual person who
`
` would be administering medication for Cushing's
`
` Syndrome.
`
` Q. So in your opinion are the claims of the
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`Veritext Legal Solutions
`215-241-1000 ~ 610-434-8588 ~ 302-571-0510 ~ 202-803-8830
`
`Teva Pharmaceuticals USA, Inc. v.
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