`David J Greenblatt , M.D.
`
`July 2, 2020
`
`In the Matter of:
`Teva Pharmaceuticals vs. Corcept
`Therapeutics
`
`Veritext Legal Solutions
`800-734-5292 | calendar-dmv@veritext.com |
`
`Teva Pharmaceuticals USA, Inc. v. Corcept Therapeutics, Inc.
`PGR2019-00048
`Corcept Ex. 2070, Page 1
`
`
`
` UNITED STATES PATENT AND TRADEMARK OFFICE
`
` _____________________
`
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`Page 1
`
` TEVA PHARMACEUTICALS USA, INC.
`
` Petitioner
`
` v.
`
` CORCEPT THERAPEUTICS, INC.
`
` Patent Owner
`
` PGR2019-00048
`
` Patent No. 10,195,214
`
` _____________
`
` Thursday, July 2, 2020
`
` Deposition of DAVID J. GREENBLATT,
`
` M.D., taken virtually via Zoom, at the
`
` home of David J. Greenblatt, M.D., beginning at
`
` 11:04 a.m., before Ryan K. Black, a Registered
`
` Professional Reporter, Certified Livenote
`
` Reporter and Notary Public in and for the
`
` Commonwealth of Pennsylvania.
`
`Veritext Legal Solutions
`215-241-1000 ~ 610-434-8588 ~ 302-571-0510 ~ 202-803-8830
`
`1
`
`2
`
`3
`
`4 5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`Teva Pharmaceuticals USA, Inc. v. Corcept Therapeutics, Inc.
`PGR2019-00048
`Corcept Ex. 2070, Page 2
`
`
`
`Page 2
`
` A P P E A R A N C E S:
`
` STERNE, KESSLER, GOLDSTEIN & FOX, P.L.L.C.
` BY: DEBORAH STERLING, PH.D., ESQ - Via Zoom
` WILLIAM H. MILLIKEN, ESQ - Via Zoom
` 1100 New York Avenue NW
` Washington, DC 20005
` 202.371,2600
` dsterling@sternekessler.com
` wmilliken@sternekessler.com
`
` Representing - Petitioner Teva Pharmaceuticals
` USA, Inc.
`
` QUINN EMANUEL URQUHART & SULLIVAN LLP
` BY: ERIC STOPS, ESQ - Via Zoom
` JOHN GALANEK, ESQ - Via Zoom
` 51 Madison Avenue
` 22nd Floor
` New York, New York 10010
` 212.849.7150
` ericstops@quinnemanuel.com
` johngalanek@quinnemanuel.com
`
` Representing - Patent Owner Corcept
` Therapeutics, Inc.
` Pharmaceuticals, Inc.
`
`Veritext Legal Solutions
`215-241-1000 ~ 610-434-8588 ~ 302-571-0510 ~ 202-803-8830
`
`1
`
`2 3
`
`4
`
`5
`
`6
`
`7
`
`8
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`Teva Pharmaceuticals USA, Inc. v. Corcept Therapeutics, Inc.
`PGR2019-00048
`Corcept Ex. 2070, Page 3
`
`
`
` I N D E X
`
` TESTIMONY OF: DAVID J. GREENBLATT, M.D. PAGE
`
` By Mr. Stops...................................4
`
`Page 3
`
` E X H I B I T S
`
` PREVIOUSLY MARKED EXHIBITS
`
` EXHIBIT PAGE
`
` 1067...........................................6
`
` 1015..........................................33
`
` 1004..........................................46
`
` 2036..........................................54
`
`Veritext Legal Solutions
`215-241-1000 ~ 610-434-8588 ~ 302-571-0510 ~ 202-803-8830
`
`1
`
`2
`
`3
`
`4 5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`Teva Pharmaceuticals USA, Inc. v. Corcept Therapeutics, Inc.
`PGR2019-00048
`Corcept Ex. 2070, Page 4
`
`
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`Page 4
`
` Whereupon --
`
` * * *
`
` DAVID J. GREENBLATT, M.D.,
`
` called to testify, having been first duly sworn
`
` or affirmed via Zoom video conference, was
`
` examined and testified as follows:
`
` * * *
`
` EXAMINATION
`
` BY MR. STOPS:
`
` Q. Good morning, Dr. Greenblatt.
`
` A. Good morning.
`
` Q. As you'll recall, my name is Eric
`
` Stops. This will be your second deposition in
`
` this proceeding, correct?
`
` A. Correct.
`
` Q. And you're appearing today in this PGR
`
` proceeding on behalf of Teva, correct?
`
` A. Correct.
`
` Q. Have you had any remote depositions
`
` taken before today?
`
` A. No.
`
` Q. Okay. And where are you physically
`
` located this morning?
`
` A. I'm in my home in a room in the
`
` basement.
`
`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. 2070, Page 5
`
`
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
` Q. Okay. Is there anyone that's involved
`
` in this matter physically present with you this
`
`Page 5
`
` morning?
`
` A. No.
`
` Q. Okay. Now, you should have received a
`
` box of paper documents from us for use in your
`
` deposition. Did you receive that box?
`
` A. I did.
`
` Q. Okay. If you haven't already, could
`
` you open up the box?
`
` A. It's open.
`
` Q. Excellent.
`
` And does the box contain manila
`
` folders with numbers on the folders?
`
` A. It does.
`
` Q. And there are documents in the
`
` folders?
`
` A. Correct.
`
` Q. Okay. And just for your information,
`
` the numbers on the folders are the exhibit
`
` numbers that the parties have been using in this
`
` PGR proceeding. That's just for your reference.
`
` A. Yes.
`
` Q. And could you confirm that you haven't
`
` written on, highlighted, flagged or otherwise
`
`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. 2070, Page 6
`
`
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`Page 6
`
` marked up the documents in the box?
`
` A. The only thing I did was write the
`
` document number on the lower right up to the
`
` upper right so that I can see it.
`
` Q. Understood. Okay.
`
` And for your deposition today,
`
` I'm going to need you to use the copy of the
`
` documents from the box. So to the extent you
`
` have any other marked-up copies of documents,
`
` notes or other materials relating to this
`
` matters, please set those aside for the duration
`
` of the deposition. Okay?
`
` A. Yes.
`
` Q. Okay. So in your box of documents,
`
` would you locate Exhibit Number 1067? That
`
` should be your second declaration.
`
` A. Yes, I have it.
`
` MR. STOPS: Okay. And give me one
`
` moment. I'm also going to move the document in
`
` the electronic system into the marked exhibits
`
` folder.
`
` (Previously marked Exhibit No. 1067,
`
` Dr. Greenblatt's second declaration, was
`
` introduced electronically.)
`
` BY MR. STOPS:
`
`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. 2070, Page 7
`
`
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`Page 7
`
` Q. Okay. And, Dr. Greenblatt, are you
`
` -- just for the purpose of the deposition, do
`
` you want to use, to the extent possible, just
`
` the paper documents, or are you also using the
`
` electronic system, as well?
`
` A. I would like to use only paper.
`
` Q. All right.
`
` A. And if you can screen share, instead
`
` of getting me into the Veritext thing, that
`
` would be good.
`
` MR. STOPS: Okay. I think that will
`
` work out just fine.
`
` And just, I guess this is a question
`
` for Deb and Ryan for this, if we're relying on
`
` the paper documents, Deb, do you also have them,
`
` or would you like me to have those put into the
`
` electronic system, as well?
`
` MS. STERLING: I have them, because I
`
` received a box. But it might be better for
`
` those following along if you dropped them into
`
` the folder.
`
` MR. STOPS: That's true. And it will
`
` also make it easier for Ryan, as well.
`
` THE REPORTER: Yes.
`
` MR. STOPS: So I will do that. I will
`
`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. 2070, Page 8
`
`
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`Page 8
`
` put them both into the electronic system, as
`
` well as identifying the paper documents.
`
` VERITEXT TECHNICIAN: And if I can
`
` just add to this without interrupting too much,
`
` the act of moving it into the exhibits folder
`
` actually marks it as an exhibit on the PDF, as
`
` well.
`
` MR. STOPS: Understood. I believe
`
` that virtually all, if not all of the documents
`
` we talked about today, are documents that are
`
` already marked as exhibits in the proceeding,
`
` so it should be --
`
` VERITEXT TECHNICIAN: Sorry for the
`
` interruption.
`
` BY MR. STOPS:
`
` Q. Okay. So back to business.
`
` Dr. Greenblatt, can you identify the
`
` Exhibit 1067 for me?
`
` A. Yes, I have it. It's the -- it's just
`
` what you said. It's the second declaration of
`
` myself.
`
` Q. Excellent.
`
` Would you turn to Paragraph 6 of your
`
` second declaration? It's on Page 2.
`
` A. Yes.
`
`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. 2070, Page 9
`
`
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`Page 9
`
` Q. And in Paragraph 6 of your second
`
` declaration, you list the materials that you
`
` considered in preparing your deposition
`
` -- sorry, in preparing your declarations,
`
` correct?
`
` A. Both declarations.
`
` Q. Yes. This is the material that
`
` you've considered in preparing both of your
`
` declarations, correct?
`
` A. Yes.
`
` Q. Okay. And you did not review anything
`
` beyond the materials cited in Paragraph 6 in
`
` formulating your opinions, correct?
`
` A. My opinions were adequately formulated
`
` based on what is listed in Paragraph 6, but in
`
` the course of my normal professional activities
`
` continuously dealing with scientific papers, et
`
` cetera, in this area.
`
` Q. Okay. Your specific opinions in this
`
` matter, though, are based on the materials
`
` listed in Paragraph 6, correct?
`
` A. Yes.
`
` Q. Okay. Is there anything else that you
`
` considered specifically for your opinions in
`
` this matter that's not listed in Paragraph 6?
`
`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. 2070, Page 10
`
`
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`Page 10
`
` A. It would be the same answer. I mean,
`
` I am continuously in contact with scientific
`
` literature, not in the context of the case, but
`
` normal professional activities, that have to do
`
` with CYP3A and drug interactions. I did not,
`
` specifically, to my recollection, rely on any of
`
` those, but, nonetheless, that's there.
`
` Q. All right. Maybe I'll ask a slightly
`
` different question, then. You did not review
`
` any materials relating to Mifepristone that form
`
` the basis for your opinions in your expert
`
` declarations beyond those listed in Paragraph 6,
`
` correct?
`
` A. Correct.
`
` MR. STOPS: Okay. Let's pause for
`
` one second. In my realtime I have a lot of
`
` things that are definitely not English. Is
`
` anybody else seeing this?
`
` MS. STERLING: I, too, am getting a
`
` lot of gibberish transcript.
`
` MR. STOPS: Okay. Is there a easy way
`
` to refresh this, Ryan?
`
` THE REPORTER: I'm not sure. I
`
` think it's coming through Remote Counsel. I'd
`
` have to -- actually, we'd have to go offline for
`
`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. 2070, Page 11
`
`
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`Page 11
`
` a minute and I'd have to reach out to them and
`
` see if they could help us.
`
` MR. STOPS: Okay. Let me try one
`
` thing. I'm going to refresh that page and see
`
` if that helps. Let's go off the record for a
`
` minute.
`
` (Brief recess.)
`
` BY MR. STOPS:
`
` Q. Dr. Greenblatt, in your Paragraph 6
`
` list of materials, the very last item on the
`
` list is Exhibit 2056, correct?
`
` A. Yes.
`
` Q. And Exhibit 2056 is the declaration of
`
` a Dr. Gingrich, correct?
`
` A. Correct.
`
` Q. And you're aware that declaration of
`
` Dr. Gingrich was submitted on behalf of the
`
` patent owner, correct?
`
` A. Correct.
`
` Q. You did not review the deposition
`
` transcript of Dr. Gingrich, correct?
`
` A. That's correct.
`
` Q. Did you ask counsel for Dr. Gingrich's
`
` deposition transcript?
`
` A. I did not.
`
`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. 2070, Page 12
`
`
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`Page 12
`
` Q. And you did not review the declaration
`
` of Dr. Carol, which was submitted on behalf of
`
` the patent owner, correct?
`
` A. Not that I can recollect.
`
` Q. And you did not review the deposition
`
` transcript of Dr. Carol, correct?
`
` A. That's correct.
`
` Q. You also did not review the
`
` declaration of Dr. Katznelson that was submitted
`
` on behalf of patent owner, correct?
`
` A. That's correct.
`
` Q. And you did not review the deposition
`
` transcript of Dr. Katznelson, correct?
`
` A. Did you just say the same thing, or
`
` did you say --
`
` Q. My first question was on the
`
` declaration of Dr. Katznelson. My second
`
` question was on the deposition transcript of
`
` Dr. Katznelson. It was, you did not review the
`
` deposition transcript of Dr. Katznelson,
`
` correct?
`
` A. Correct.
`
` Q. And you did not review the declaration
`
` of Dr. Dobbs, which was submitted on behalf of
`
` petitioner, correct?
`
`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. 2070, Page 13
`
`
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`Page 13
`
` A. Correct.
`
` Q. And you did not review the deposition
`
` transcript of Dr. Dobbs, correct?
`
` A. Correct.
`
` Q. You also did not speak with Dr. Dobbs
`
` in formulating your opinions for this case, or,
`
` rather, this proceeding, correct?
`
` A. Correct.
`
` Q. Other than counsel, you did not speak
`
` with anyone in formulating your opinions for
`
` this proceeding, correct?
`
` A. I spoke with counsel, but I formulated
`
` my own opinion.
`
` Q. Yes. So I was just asking you in
`
` terms of if there was anyone other than counsel
`
` that you spoke with in formulating your
`
` opinions?
`
` A. No one else.
`
` Q. Okay. Thank you.
`
` And you did not review any clinical
`
` practice guidelines for the treatment of
`
` Cushing's Syndrome in formulating your opinions,
`
` correct?
`
` MS. STERLING: Objection to form.
`
` THE WITNESS: Correct. Sorry. That
`
`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. 2070, Page 14
`
`
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`Page 14
`
` is correct.
`
` BY MR. STOPS:
`
` Q. And did you not review any journal
`
` articles regarding the treatment of Cushing's
`
` Syndrome in formulating your opinions, correct?
`
` MS. STERLING: Objection; form.
`
` THE WITNESS: That's correct.
`
` BY MR. STOPS:
`
` Q. Now, in Paragraph 4 of your second
`
` declaration, you note that Corcept has proposed
`
` a definition for the person of ordinary skill in
`
` the art that differs from your definition,
`
` correct?
`
` A. Correct.
`
` Q. And you're comfortable with the use
`
` of the acronym POSA for the person of ordinary
`
` skill in the art, correct?
`
` A. Yes. Correct.
`
` Q. And you disagree with Corcept's
`
` proposed definition of the POSA, correct?
`
` A. In part.
`
` Q. Yes. And the part that you disagree
`
` with is the Corcept's requirement of a medical
`
` professional with experience treating Cushing's
`
` Syndrome, correct?
`
`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. 2070, Page 15
`
`
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`Page 15
`
` A. Correct.
`
` Q. So it is your opinion that a medical
`
` professional with experience treating Cushing's
`
` Syndrome does not need to be part of the POSA or
`
` POSA team, correct?
`
` MS. STERLING: Objection to form.
`
` THE WITNESS: Not correct.
`
` BY MR. STOPS:
`
` Q. My understanding if -- okay.
`
` Does a medical professional with
`
` experience treating Cushing's Syndrome need to
`
` be part of the POSA or POSA team?
`
` MS. STERLING: Objection to form.
`
` THE WITNESS: Going to my own concept
`
` of POSA, it utilizes a team approach. And an
`
` individual of that type could be called upon and
`
` included, if necessary, but it's not obligatory.
`
` BY MR. STOPS:
`
` Q. Okay. So under your definition of the
`
` person of skill in the art, or person of skill
`
` in the art team, it is not obligatory to include
`
` a medical professional with experience treating
`
` Cushing's Syndrome; is that right?
`
` MS. STERLING: Object to form.
`
` THE WITNESS: Sorry.
`
`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. 2070, Page 16
`
`
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
` Same answer. I feel it is not
`
` obligatory, but such a person could participate,
`
`Page 16
`
` if needed.
`
` BY MR. STOPS:
`
` Q. Okay. And is such a person needed for
`
` the purposes of rendering the opinions contained
`
` in your declarations?
`
` A. I believe not.
`
` Q. Okay. In Paragraph 7 of your
`
` declaration, you list drug-drug interaction
`
` study variables that come from Dr. Gingrich's
`
` declaration, correct?
`
` MS. STERLING: Objection to form.
`
` THE WITNESS: Could you say that
`
` again?
`
` BY MR. STOPS:
`
` Q. Sure.
`
` In Paragraph 7 of your second
`
` declaration, you quote Dr. Gingrich's
`
` declaration where he lists a series of drug
`
` interaction study variables, correct?
`
` A. Yes, I have a quote from Dr. Gingrich.
`
` Q. And the quote from Dr. Gingrich
`
` concerns variables used in drug interaction
`
` studies, correct?
`
`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. 2070, Page 17
`
`
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
` MS. STERLING: Objection to form.
`
` THE WITNESS: Well, it is the list of
`
`Page 17
`
` such things, yes.
`
` BY MR. STOPS:
`
` Q. Okay. I guess, as an initial matter,
`
` based on your experience, are there any
`
` additional factors or variables that should be
`
` added to this list?
`
` A. I can't exclude it, but I would have
`
` to take some time to sit down and think about,
`
` if I thought it was useful to construct such a
`
` list, what might be added.
`
` Q. Okay. You have not done that exercise
`
` yet, correct?
`
` A. That's correct. I have not done such
`
` an exercise.
`
` Q. Okay. And there's no factors or
`
` variables that you would add sitting here today
`
` without further time to reflect; is that
`
` correct?
`
` A. I think I just answered that. I would
`
` need to think -- if I were to construct a list,
`
` if I thought it was useful to construct a list,
`
` I would have to consider what might be added.
`
` Q. Okay. And the variables that
`
`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. 2070, Page 18
`
`
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`Page 18
`
` Dr. Gingrich had cited in the quotation in your
`
` declaration, those come from the 2006 Drug
`
` Interaction Guidance, correct?
`
` MS. STERLING: Objection; foundation.
`
` Form.
`
` THE WITNESS: That I don't know. I
`
` haven't cross-checked.
`
` BY MR. STOPS:
`
` Q. Okay. Okay.
`
` You're aware that there are variables
`
` or factors listed in the 2006 drug interaction
`
` guidance, correct?
`
` MS. STERLING: Objection; form.
`
` THE WITNESS: I am aware, yes.
`
` BY MR. STOPS:
`
` Q. Okay. In your opinion, are all drug
`
` interaction studies routine?
`
` A. In my opinion, no study is routine.
`
` A study has to be -- the design of a study
`
` has to be thought through and the variables
`
` considered and the study is designed. That
`
` takes some thought, and that's not like you do
`
` it in 30 seconds. But, in general, for any
`
` particular question, a study can be designed.
`
` Q. Okay. In Paragraph 8, you state on
`
`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. 2070, Page 19
`
`
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
` the very bottom of Page 5, you refer to the, "in
`
` my field." Do you see those lines at the very
`
`Page 19
`
` bottom of Page 5?
`
` A. Yes.
`
` Q. What do you mean by, "your field," for
`
` that, in this context?
`
` A. Well, in general, the field of
`
` clinical pharmacology, pharmacokinetics drug
`
` interactions, metabolic inhibition and induction
`
` and these are things that a POSA would deal
`
` with.
`
` Q. Okay. All right. I'm just trying to
`
` read from the screen.
`
` In Paragraph 10 of your second
`
` declaration on Page 6, you begin your discussion
`
` of the variables or factors for drug interaction
`
` study designs, correct?
`
` A. Well, I think Paragraph 10 stands as
`
` stated; for example, with respect to the first
`
` variable, study design, and it goes on.
`
` Q. Sure.
`
` The paragraph, and I believe it goes
`
` from Paragraph 10 through Paragraph 20 of your
`
` report, concern your opinions on the variables
`
` used in drug interaction studies, correct?
`
`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. 2070, Page 20
`
`
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`Page 20
`
` MS. STERLING: Objection to form, and
`
` to the extent it misstates testimony.
`
` THE WITNESS: Well, I think I would
`
` just leave the content of Paragraphs 10 through
`
` 20 as they are. I mean, each one considers a
`
` point and discusses it. So I would stand by
`
` that content.
`
` BY MR. STOPS:
`
` Q. Okay. Now, you could have discussed
`
` the variables used in drug interaction studies
`
` in your first declaration, correct?
`
` A. How do you mean, "I could have?"
`
` Q. This discussion of -- of the variables
`
` used in drug interaction studies could have been
`
` part of your first declaration, correct?
`
` MS. STERLING: Objection; form.
`
` Relevance.
`
` THE WITNESS: Well, this declaration
`
` is -- you know, stands on its own. I mean, it's
`
` -- you know, the first declaration is what it is
`
` and it stands on its own. So I don't know how
`
` to answer that. I mean, I could have -- I guess
`
` -- I don't know.
`
` BY MR. STOPS:
`
` Q. Well, I mean, why didn't you include a
`
`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. 2070, Page 21
`
`
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`Page 21
`
` discussion on drug interaction study variables
`
` in your first declaration?
`
` MS. STERLING: Objection; form.
`
` Relevance.
`
` THE WITNESS: If I didn't, I don't
`
` know.
`
` BY MR. STOPS:
`
` Q. Okay. In Paragraph 12 of your second
`
` declaration, you state at the very end, "the
`
` study will be expected to yield a reliable
`
` result."
`
` Do you see that sentence?
`
` A. I do.
`
` Q. What did you mean by, "a reliable
`
` result?"
`
` A. Well, a result that's scientifically
`
` valid and interpretable.
`
` Q. Just so I'm clear, could you give me
`
` an example of the opposite? When would a result
`
` be unreliable?
`
` A. I really can't answer that, because I
`
` generally don't try to design studies like that.
`
` Q. Understood.
`
` Have you reviewed or seen any
`
` drug interaction studies that you would have
`
`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. 2070, Page 22
`
`
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`Page 22
`
` considered resulting in an unreliable result?
`
` MS. STERLING: Objection to form.
`
` THE WITNESS: My expectation is, yes.
`
` But I cannot, at this point, point to any.
`
` BY MR. STOPS:
`
` Q. Can two studies that are
`
` scientifically valid yield opposite results?
`
` MS. STERLING: Objection to form.
`
` THE WITNESS: Well, I don't think that
`
` opposite is the right word. The point is that
`
` two studies can be well-executed with proper
`
` designs and yield scientifically accurate and
`
` interpretable results, yet the two different
`
` studies might not agree. That doesn't mean that
`
` they're opposite, but they might not fully
`
` agree.
`
` BY MR. STOPS:
`
` Q. Okay. How is it that two studies that
`
` are scientifically valid could yield results
`
` that do not fully agree?
`
` A. Well, let's say the studies were done
`
` at different sites, in different laboratories
`
` using different subjects using different doses
`
` of the same drug using different kinds of study
`
` designs, analytical methods, statistical
`
`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. 2070, Page 23
`
`
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`Page 23
`
` methods. So they may be studying the same
`
` subject, and both give reliable results in their
`
` context, but they don't necessarily have to
`
` agree a hundred percent.
`
` Q. Okay. So different factors in
`
` different analyses can yield different results,
`
` correct?
`
` MS. STERLING: Objection to form.
`
` THE WITNESS: I would stick with the
`
` answer I just gave.
`
` BY MR. STOPS:
`
` Q. Okay. Sir, two drug interaction
`
` studies that were done under different
`
` conditions could both be scientifically valid,
`
` yet yield results that do not agree, correct?
`
` MS. STERLING: Objection; form.
`
` Misstates testimony.
`
` THE WITNESS: My prior answer stands,
`
` and a drug interaction study is a study. So
`
` that's encompassed in the prior answer.
`
` BY MR. STOPS:
`
` Q. Do you agree that two drug interaction
`
` studies that were done under different
`
` conditions could both be scientifically valid
`
` yet yield results that do not agree?
`
`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. 2070, Page 24
`
`
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16