throbber
Page 1
`
`IN THE 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
`------------------
`
` VIRTUAL DEPOSITION OF F. PETER GUENGERICH
`May 14, 2020
`
`Reported by:
`ERICA L. RUGGIERI, RPR
`
`800-642-1099
`
`David Feldman Worldwide
`A Veritext Company
`
`www.veritext.com
`
`12
`
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`1
`
`TEVA1070
`Teva Pharmaceuticals USA, Inc. v. Corcept Therapeutics, Inc.
`PGR2019-00048
`
`

`

`Page 2
`
` May 14, 2020
` 9:10 a.m.
`
` Deposition of F. PETER
` GUENGERICH, held by Virtual Zoom
` Conference, pursuant to Notice, before
` Erica L. Ruggieri, Registered
` Professional Reporter and Notary
` Public of the State of New York.
`
`12
`
`3
`
`456
`
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`800-642-1099
`
`David Feldman Worldwide
`A Veritext Company
`
`www.veritext.com
`
`2
`
`

`

`Page 3
`
`A P P E A R A N C E S:
`ATTORNEYS FOR TEVA PHARMACEUTICALSUSA, INC.:
`STERNE KESSLER GOLDSTEIN & FOX PLLC
` 1100 New York Ave NW, 6th Floor
` Washington DC 20005
`BY: DEBORAH A. STERLING, ESQ., Ph.D.
` dsterling@sternekessler.com
` WILLIAM MILLIKEN, ESQ.
` wmilliken@sternekessler.com
`
`ATTORNEYS FOR CORCEPT THERAPEUTICS, INC.:
`QUINN EMANUEL URQUHART & SULLIVAN LLP f
` 51 Madison Ave, 22nd Floor
` New York, New York 10010
` BY: ERIC STOPS, ESQ.
` ericstops@quinnemanuel.com
` JOHN P. GALANEK, ESQ.
` johnGalanek@quinnemanuel.com
`
`12
`
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`800-642-1099
`
`David Feldman Worldwide
`A Veritext Company
`
`www.veritext.com
`
`3
`
`

`

`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
`
` F. PETER GUENGERICH
` F. PETER GUENGERICH, called as a
` witness, having been duly sworn by a
` Notary Public, was examined and
` testified as follows:
` EXAMINATION BY
` MS. STERLING:
` Q. Good morning, Dr.
` Guengerich. How are you doing?
` A. Good morning. I'm fine,
` thank you.
` Q. All right, good. Can you
` please state your full name for the
` record?
` A. My name is Frederick Peter
` Guengerich.
` Q. My name is Deborah
` Sterling. I'm with the law firm of
` Sterne Kessler Goldstein & Fox and
` I'm going to be taking your
` deposition today. Is that okay?
` A. Yes.
` Q. Okay. Can you please give
` us your location?
` A. My location, I'm at
`
`800-642-1099
`
`David Feldman Worldwide
`A Veritext Company
`
`www.veritext.com
`
`4
`
`

`

`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
`
` F. PETER GUENGERICH
` Vanderbilt University in Nashville,
` Tennessee.
` Q. Are you in your office at
` the university?
` A. Yes, I am.
` Q. And it seems from your
` declaration you've been deposed in
` four cases; is that right?
` A. That's, I think, in the
` last four years. That's not the
` total.
` Q. Okay. Do you have an idea
` of how many times you've been
` deposed in total, just a ballpark?
` A. 12 to 15 going back
` 25 years.
` Q. Are those cases patent
` cases or other types of cases?
` A. They are primarily patents,
` not exclusively but primarily patent
` issues, mostly with drugs.
` Q. And it appears you have
` been deposed in the post grant
` proceedings before the patent office
`
`800-642-1099
`
`David Feldman Worldwide
`A Veritext Company
`
`www.veritext.com
`
`5
`
`

`

`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
`
` F. PETER GUENGERICH
` before as well; is that correct?
` A. As I recall, twice.
` Q. Okay. You've been deposed
` a lot but I'll still go over some
` ground rules just to make sure we
` are all working well together. Is
` that okay?
` A. Fine. They change
` sometimes. This is the first time I
` have done a video one.
` Q. Yes. It's the first time
` for most people. You are being
` disposed today because you submitted
` a deposition in post grant
` proceedings PGR2019-00048. And do
` you understand that your testimony
` today will be recorded and the
` transcript will be made public?
` A. Yes.
` Q. And do you understand that
` you are testifying under oath and
` under penalty of perjury?
` A. I do.
` Q. Okay. That means that you
`
`800-642-1099
`
`David Feldman Worldwide
`A Veritext Company
`
`www.veritext.com
`
`6
`
`

`

`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
`
` F. PETER GUENGERICH
` are here to testify truthfully and
` accurately regarding the opinions
` and information you put forth in
` your declaration.
` You understand that?
` A. I understand.
` Q. Is there any reason you
` can't testify truthfully and
` accurately today?
` A. No.
` Q. Okay. Dr. Guengerich, I'm
` going to try and use English words
` and I'll expect you understand the
` meaning of the words I use. If you
` don't understand the meaning of the
` words, please tell me and I'll do my
` best to clarify. Is that okay?
` A. Fine.
` Q. If you answer, I'm going to
` assume that you understood my
` question. Okay?
` A. Correct.
` Q. We have a court reporter
` today and, as you've pointed out, we
`
`800-642-1099
`
`David Feldman Worldwide
`A Veritext Company
`
`www.veritext.com
`
`7
`
`

`

`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
`
` F. PETER GUENGERICH
` are remote. And so I'm going to ask
` -- I'm going to do my best to not
` talk over you and I ask that you do
` your best to not talk over me too.
` Is that okay?
` A. Yes.
` Q. And your attorney may step
` in and provide objections now and
` again. I'm sure you understand
` unless your attorney instructs you
` to not answer the question you still
` have to go forward and answer my
` question. Is that okay?
` A. I understand.
` Q. I'm going to try and take a
` break every hour roughly, give or
` take, depending on the questions.
` If you need a break at any other
` time, please let me know. Will you?
` A. Sure. Of course.
` Q. Unless it's an emergency, I
` just ask that you would answer the
` question that's pending if there's
` one pending before you take that
`
`800-642-1099
`
`David Feldman Worldwide
`A Veritext Company
`
`www.veritext.com
`
`8
`
`

`

`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
`
` F. PETER GUENGERICH
` break. Okay?
` A. Okay.
` Q. Okay. Have the rules
` changed that much?
` A. Not so far.
` Q. So you've never been
` deposed remotely?
` A. No, I haven't.
` Q. You have not. You
` mentioned you were at your office at
` the University of Vanderbilt; is
` that right?
` A. That's correct.
` Q. Can you briefly describe
` your environment aside from the
` aurora that we can see behind you?
` A. I'm in my office. I have a
` faculty office.
` Q. Are you alone?
` A. Yes.
` Q. Do you have any materials
` related to your declaration or this
` deposition with you in your office?
` MR. STOPS: Counsel, I'll
`
`800-642-1099
`
`David Feldman Worldwide
`A Veritext Company
`
`www.veritext.com
`
`9
`
`

`

`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
`
` F. PETER GUENGERICH
` represent that we have provided
` Dr. Guengerich with a set of his
` declaration and the exhibits that
` are set forth in the Exhibit C to
` the declaration. I believe they
` are all in their entirety but I'm
` not a hundred percent positive of
` that.
` Q. Dr. Guengerich, the copies
` that you have with you today, are
` they clean copies as far as --
` A. They only have yellow
` highlights on them. No other marks.
` Q. And who made the yellow
` highlights?
` A. I'm sorry, what?
` Q. Who made those yellow
` highlights?
` A. I did.
` Q. What equipment are you
` using to participate in this
` deposition?
` A. I'm using a computer, a
` Macintosh computer. It's operating
`
`800-642-1099
`
`David Feldman Worldwide
`A Veritext Company
`
`www.veritext.com
`
`10
`
`

`

`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
`
` F. PETER GUENGERICH
` on a Catalina system, if that means
` anything.
` Q. Not to me. Sorry. Are you
` using a phone as well?
` A. No.
` Q. No. Just your computer?
` A. That's correct.
` Q. Are you communicating with
` your counsel through any means
` throughout this deposition?
` A. Yeah. There's --
` MR. STOPS: Other than through
` this -- you mean while the
` deposition is ongoing, other than
` through this Zoom call?
` Q. Yes. While the deposition
` is ongoing.
` MR. STOPS: So you're leaving
` aside this Zoom call.
` Q. Aside from this Zoom call
` or in addition to this Zoom call?
` A. There's -- well, we had a
` premeeting this morning but nothing
` live right now.
`
`800-642-1099
`
`David Feldman Worldwide
`A Veritext Company
`
`www.veritext.com
`
`11
`
`

`

`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
`
` F. PETER GUENGERICH
` Q. And Dr. Guengerich, how did
` you -- what did you do to prepare
` your declaration?
` A. I read a number of papers.
` I discussed things with counsel and
` had a meeting with Mr. Stops and two
` other lawyers from Quinn Emanuel.
` Q. And roughly how much time
` did you spend preparing your
` declaration for this case?
` A. I'm not exactly sure.
` Q. Do you have a ballpark?
` A. I would estimate between
` ten and 20 hours without checking on
` it.
` Q. I'm going to actually
` upload your declaration. Even
` though you have a paper copy there,
` I will upload it. It should be in
` our shared site. Let me know when
` you have it.
` (Exhibit 2056, declaration,
` marked for identification, as of
` this date.)
`
`800-642-1099
`
`David Feldman Worldwide
`A Veritext Company
`
`www.veritext.com
`
`12
`
`

`

`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
`
` F. PETER GUENGERICH
` MR. STOPS: Dr. Guengerich,
` you may have to click off of that
` folder and then back onto it to
` refresh it.
` MS. STERLING: Yeah. Often I
` just click the refresh button at
` the top and the documents should
` show up on it.
` A. I have it.
` Q. Can you please look at that
` document and make sure it's the same
` declaration that you have in front
` of you in paper. And you can work
` off your preference, either the
` paper copy or the electronic copy.
` A. I'll work off the paper
` copy. I'm actually going to
` download that to be safe here but
` I'll check it right now.
` Q. Okay. I think it makes
` sense to download it.
` MR. STOPS: Just from a
` topology perspective, I don't know
` if yours works the same way as mine
`
`800-642-1099
`
`David Feldman Worldwide
`A Veritext Company
`
`www.veritext.com
`
`13
`
`

`

`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
`
` F. PETER GUENGERICH
` does but when I click on the pdf it
` opens up directly in that window, I
` don't have to download it to my
` desktop and then start switching
` back and forth between windows.
` Q. It's your choice,
` Dr. Guengerich. If you prefer to
` download it, just --
` A. I have already downloaded
` it.
` Q. Yeah, that's my preference
` in case there's a technical glitch
` in the website then you have the
` document.
` A. Okay. This seems to be
` fine. The same thing that I turned
` in.
` Q. You have an Appendix C to
` your declaration. If you can turn
` to that, it's right at the end. Are
` you there?
` A. Yes.
` Q. Is this a complete listing
` of the documents that you relied
`
`800-642-1099
`
`David Feldman Worldwide
`A Veritext Company
`
`www.veritext.com
`
`14
`
`

`

`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
`
` F. PETER GUENGERICH
` upon in preparing your declaration?
` A. Yes, it is. I would add
` that I indicated in item 16 of my
` declaration that I have also further
` drawn on my general experience in
` pharmacokinetics and
` pharmacodynamics, but I think for
` our purposes this is a rather
` complete aside from anything else.
` Q. Okay. So aside from your
` experience in the field, are there
` any other documents that you relied
` upon in preparing your declaration
` that are not provided in Exhibit C?
` A. No.
` Q. Did you identify the
` documents in Exhibit C or were they
` provided to you by counsel for
` Corcept?
` A. Combination of the two.
` Q. Which ones did you provide?
` A. Actually, I'm not totally
` sure about these, that I did a
` literature search myself and I'm not
`
`800-642-1099
`
`David Feldman Worldwide
`A Veritext Company
`
`www.veritext.com
`
`15
`
`

`

`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
`
` F. PETER GUENGERICH
` positive exactly which ones I did
` identify independently. The FDA
` documents were provided to me by
` counsel.
` Q. Which -- if you could give
` me the exhibit number that you are
` referring to that would be helpful.
` A. Well the -- let's see.
` Well, of course 1002 is the
` declaration of Dr. Greenblatt. The
` Korlym label was provided by
` counsel. I'm sorry, 1004. 1005 is
` an FDA document. 1006 is an FDA
` document. I'm not even sure --
` these are not readily available and
` I know those were definitely
` provided by counsel.
` Q. Again refreshing your
` memory with this list, do any -- are
` any of these -- can you tell me
` which, if any, of these you
` provided?
` A. I think possibly the, where
` is it, the Djang, I think might have
`
`800-642-1099
`
`David Feldman Worldwide
`A Veritext Company
`
`www.veritext.com
`
`16
`
`

`

`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
`
` F. PETER GUENGERICH
` done that. Some of Greenblatt's
` papers. Oh, by the way, 1035 is the
` file history of the patent. I
` didn't provide that definitely.
` Q. Okay. Switching from your
` declaration to your deposition.
` Generally what did you do to prepare
` for your deposition today? Just at
` a high level.
` MR. STOPS: And I'll caution
` you not to reveal any
` attorney-client communications, the
` substance of the communications
` with counsel.
` A. I met with several of the
` lawyers from Quinn Emanuel over the
` last two days by video.
` Q. Did you review any
` documents in preparing your
` deposition today?
` MR. STOPS: And again, I'll
` caution you not to reveal the
` substance of any of the
` discussions. You can answer that
`
`800-642-1099
`
`David Feldman Worldwide
`A Veritext Company
`
`www.veritext.com
`
`17
`
`

`

`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
`
` F. PETER GUENGERICH
` question yes, no, or I don't know.
` A. I reviewed the documents
` that are listed as exhibits that are
` in my binder. And the list is in
` Exhibit C, which we just talked
` about.
` Q. Did you review any
` materials in addition to your
` declaration and the documents listed
` in Exhibit C?
` A. No, I don't think so.
` Q. So I'm going to ask you a
` little -- a few questions about your
` background, Dr. Guengerich. And is
` it fair to say that your research
` focuses on the cytochrome P450
` proteins?
` A. Yes. A large part of it
` does. It's not the only thing we
` do.
` Q. And cytochrome P450
` proteins include CYP3A inhibitors;
` is that right?
` A. Well, the -- I don't think
`
`800-642-1099
`
`David Feldman Worldwide
`A Veritext Company
`
`www.veritext.com
`
`18
`
`

`

`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
`
` F. PETER GUENGERICH
` that your question was correct. You
` said -- well, would you restate the
` question. I think...
` Q. Well, let me ask you more
` broadly then. How are CYP3A
` inhibitors related to cytochrome
` P450 proteins?
` A. Well, they are inhibitors
` of the enzymes, the proteins
` themselves. The inhibitors are
` small molecules and they bind to the
` proteins and can, you know, do
` things to the proteins to change the
` function. Many times inhibit the
` proteins.
` Q. And you are not a medical
` doctor, right?
` A. I am not.
` Q. So you have not treated any
` patients that have Cushing's
` syndrome, correct?
` A. That's correct. That would
` be illegal for me to treat patients.
` Q. So you've never prescribed
`
`800-642-1099
`
`David Feldman Worldwide
`A Veritext Company
`
`www.veritext.com
`
`19
`
`

`

`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
`
` F. PETER GUENGERICH
` mifepristone or ketoconazole to a
` patient, have you?
` A. Of course not. Again, that
` would be illegal.
` Q. Have you ever designed a
` clinical study?
` A. When you say a clinical
` study, you are meaning -- well, I
` think you mean an in vivo study.
` Q. In patients.
` A. I have participated in the
` design of clinical studies. I
` haven't done one myself.
` Q. When you say you've
` participated in the design of a
` clinical study, what was your role?
` A. As an advisor and part of
` the team.
` Q. What was your contribution
` to that clinical study design?
` A. Basic understanding of the
` system involved, the systems
` involved.
` Q. Was that study a clinical
`
`800-642-1099
`
`David Feldman Worldwide
`A Veritext Company
`
`www.veritext.com
`
`20
`
`

`

`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
`
` F. PETER GUENGERICH
` drug-drug interaction study?
` A. Yes.
` Q. Can you tell me which drugs
` were involved, unless there's any
` confidentiality involved?
` A. This is proprietary. It
` was as part of work, consultant work
` for a pharmaceutical company.
` Q. Can you give me the company
` name?
` A. I think that's proprietary
` too. Actually, there were --
` there's more than one, but it's
` proprietary.
` Q. Okay. So when you say you
` were an advisor and part of a -- let
` me go back I just want to make sure
` I got this right. Your role was
` basic understanding of the system
` involved, the systems involved. And
` so again, without revealing the
` proprietary information that you
` can't share with us did you
` determine what type of clinical
`
`800-642-1099
`
`David Feldman Worldwide
`A Veritext Company
`
`www.veritext.com
`
`21
`
`

`

`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
`
` F. PETER GUENGERICH
` study was being done, for example, a
` randomized study or a crossover
` study?
` MR. STOPS: Objection.
` A. No. I wasn't involved in
` those decisions.
` Q. Were you involved in any
` decisions regarding dosing of the
` active ingredients involved in the
` study?
` A. No. I didn't set the
` doses.
` Q. So you did not set the
` dosing regimen either?
` A. That's correct.
` Q. Did you determine the
` patient population that was involved
` in that clinical study?
` A. No.
` Q. And my understanding is
` that when you were involved in that
` clinical study, the drugs being
` administered, they were already
` known, is that fair, accurate?
`
`800-642-1099
`
`David Feldman Worldwide
`A Veritext Company
`
`www.veritext.com
`
`22
`
`

`

`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
`
` F. PETER GUENGERICH
` MR. STOPS: Objection. Vague.
` Q. Without giving me their
` names you knew which drugs were
` being administered to the patients
` in that trial already, is that fair?
` A. Yes.
` Q. Have you ever served as a
` principal investigator on a clinical
` study?
` A. No.
` Q. Have you ever assisted with
` a clinical study in another role
` other than principal investigator
` and the advisor role that we have
` already discussed?
` A. No.
` Q. Outside of this PGR
` proceeding do you have any
` relationship or have you had any
` relationship in the past with
` Corcept?
` A. No, I haven't.
` Q. I'm going to turn to your
` declaration now, Dr. Guengerich.
`
`800-642-1099
`
`David Feldman Worldwide
`A Veritext Company
`
`www.veritext.com
`
`23
`
`

`

`Page 24
`
`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
`
` F. PETER GUENGERICH
` Could you please turn to page 10.
` I'd like to start paragraph 30. Or
` sorry, page 11 paragraph 31. So
` this is the first paragraph in a
` section entitled Legal Standards.
` Do you see that?
` A. Yes.
` Q. You are not a lawyer,
` correct?
` A. That's correct.
` Q. These legal standards and
` your understanding, does that come
` from counsel for Corcept?
` A. I think this is generally
` standard language; yes, I agree with
` it.
` Q. When you say this is
` generally standard language, what do
` you mean?
` A. I think it's typical of
` what I have seen in other legal
` cases I have been involved with and
` that I don't offer an opinion on the
` law itself and I agree with the
`
`800-642-1099
`
`David Feldman Worldwide
`A Veritext Company
`
`www.veritext.com
`
`24
`
`

`

`Page 25
`
`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
`
` F. PETER GUENGERICH
` other things and didn't really
` affect my analysis.
` Q. The legal standards that
` you provide in paragraph 32 through
` 37 in your declaration, were they
` provided to you by counsel for
` Corcept?
` A. I'm sorry, what was the
` range, beginning at 32 to what?
` Q. Basically it's 32 through
` 37. This section entitled Legal
` Standards. It actually begins at
` paragraph 36.
` A. Okay. The -- yeah, this
` was provided by counsel. I agree
` with it.
` Q. Let's turn to paragraph 40
` in your declaration -- just a few
` pages over. Let me know when you
` are there.
` A. I'm there.
` Q. You say, "I understand that
` in order for the claims to be
` obvious, a POSA must have had a
`
`800-642-1099
`
`David Feldman Worldwide
`A Veritext Company
`
`www.veritext.com
`
`25
`
`

`

`Page 26
`
`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
`
` F. PETER GUENGERICH
` reasonable expectation of success,
` i.e., a reasonable that expectation
` 600 milligrams of mifepristone daily
` in combination with a strong CYP3A
` inhibitor would be safe and
` effective in patients with Cushing's
` syndrome."
` Do you see that?
` A. Yes.
` Q. So under the obviousness
` inquiry, as you understand it, is it
` your position that in order for the
` claimed invention to be obvious here
` a POSA would have had to reasonably
` expect that the claimed dose of
` 600 milligrams mifepristone could be
` safely administered with a strong
` CYP3A inhibitor in patients with
` Cushing's syndrome?
` A. Actually, I believe that's
` what the sentence states. I'll read
` it again. I understand that in
` order for the claims to be obvious a
` person of ordinary skill in the art
`
`800-642-1099
`
`David Feldman Worldwide
`A Veritext Company
`
`www.veritext.com
`
`26
`
`

`

`Page 27
`
`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
`
` F. PETER GUENGERICH
` must have had a reasonable
` expectation of success of, that is,
` a reasonable expectation that
` 600 milligrams of mifepristone daily
` in combination with a strong CYP3A
` inhibitor would be safe and
` effective in patients with Cushing's
` syndrome.
` Q. I notice there as you read
` your sentence, the sentence says
` "POSA," you said person of ordinary
` skill in the art. If I use the term
` "POSA" today, will you understand
` that I'm meaning person of ordinary
` skill in the art?
` A. I think that's fine. I'm
` not a big fan of abbreviations and
` acronyms, but that's fine.
` Q. I will try and use the full
` person of ordinary skill in the art
` but I any jump into POSA. I'm used
` to the acronym.
` A. Fine.
` Q. Okay. Thank you.
`
`800-642-1099
`
`David Feldman Worldwide
`A Veritext Company
`
`www.veritext.com
`
`27
`
`

`

`Page 28
`
`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
`
` F. PETER GUENGERICH
` I'm going to upload a document
` for you now. I have uploaded for
` you what has been previously marked
` as Exhibit 1001 and it's U.S. Patent
` No. 10,195,214. Please let me know
` when that has appeared in your
` folder. I think you may need to hit
` refresh.
` (Exhibit 1001, U.S. Patent No.
` 10,195,214, marked for
` identification, as of this date.)
` A. I have got it. Just hang
` on. I'm downloading it.
` Q. No worries, take your time.
` Again, feel free to work off the
` paper copy if that's more suitable
` for you. I assume you have that
` exhibit in your box.
` A. All right, I have it.
` Q. I'd like you to turn to the
` claims, please. Those are right at
` the end of the document. And they
` start at column 68, which is the
` penultimate page on this document.
`
`800-642-1099
`
`David Feldman Worldwide
`A Veritext Company
`
`www.veritext.com
`
`28
`
`

`

`Page 29
`
`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
`
` F. PETER GUENGERICH
` Let me know when you are there.
` A. I have it.
` Q. Okay. And they continue
` over to column 69. So could you
` please look at claim 1 of the '214
` patent. And is it okay if I call
` this the '214 patent?
` A. That's fine.
` Q. Okay. Could you please
` look at claim one of the '214
` patent. It appears at the top of
` column 68. Please read that to
` yourself.
` A. I have read it.
` Q. Okay. Now the words "safe"
` or "safely" do not appear in claim 1
` of the '214 patent, do they?
` A. No.
` Q. I'd like you to read
` through the other claims to confirm
` that the words "safe" or "safely" do
` not appear in any claim in the '214
` patent?
` A. No, not explicitly.
`
`800-642-1099
`
`David Feldman Worldwide
`A Veritext Company
`
`www.veritext.com
`
`29
`
`

`

`Page 30
`
`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
`
` F. PETER GUENGERICH
` Q. Given that the words "safe"
` or "safely" do not appear in any
` claim in the '214 patent, what is
` the basis for your concluding that
` the claimed invention contains a
` requirement that mifepristone be
` safely co-administered with a strong
` CYP3A inhibitor in patients with
` Cushing's syndrome?
` A. In my opinion, the words
` "treating," for instance, in claim
` 1, method of treating Cushing's
` syndrome, the word "treating" also
` appears in claim 5, and also in
` claim 10, it says a method of
` controlling hyperglycemia, secondary
` to hypercortisolism, I think this is
` implicit that the drug be safe and
` effective in order to be used in
` treatment.
` Q. Can you please turn in the
` '214 patent to column 19 let me know
` when you are there. Are you at
` column 19?
`
`800-642-1099
`
`David Feldman Worldwide
`A Veritext Company
`
`www.veritext.com
`
`30
`
`

`

`Page 31
`
`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
`
` F. PETER GUENGERICH
` A. I have it.
` Q. So if you look at the line
` numbers down the center between the
` two columns, I'd like you to go down
` to the paragraph that starts at line
` 62 and it begins with the word
` "Treat" in quotation marks. Do you
` see that paragraph?
` A. Yes.
` Q. Okay. So can you please
` read this definition of treat,
` treating and treatments, and in the
` patent itself it continues onto line
` 20 or, I'm sorry, column 20 about
` line 8. Please read that to
` yourself.
` A. I have read it.
` Q. Now the definition of
` treat, treating and treatment as
` provided in the '214 patent does not
` have any indication or requirement
` for safety, correct?
` A. Well, it's not explicit.
` On the other hand, I would argue
`
`800-642-1099
`
`David Feldman Worldwide
`A Veritext Company
`
`www.veritext.com
`
`31
`
`

`

`Page 32
`
`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
`
` F. PETER GUENGERICH
` that if one were to be successful,
` one would have to be treating a
` patient safely. Physicians are
` taught, it's kind of a buzz word, do
` no harm in their medical education.
` Q. When you say to be
` successful, where does that come
` from?
` A. Successful? Well, we are
` talking, for instance, here at line
` 62 or 62 and 63 says, "refer to any
` indicia of success in the
` treatment."
` Q. So it says here to treat in
` quotations, treating in quotations,
` and treatment in quotations refer to
` "any indicia of success in the
` treatment or amelioration of a
` pathology or condition including."
` And then the patent goes on to list
` those indicia of success, correct?
` A. Correct.
` Q. So those indicia of
` success, none of them have a safety
`
`800-642-1099
`
`David Feldman Worldwide
`A Veritext Company
`
`www.veritext.com
`
`32
`
`

`

`Page 33
`
`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
`
` F. PETER GUENGERICH
` requirement, right?
` MR. STOPS: Objection.
` Mischaracterizes the witness's
` testimony.
` Q. I'm asking a question about
` the patent to be clear,
` Dr. Guengerich. The indicia of
` success listed in the patent -- and
` none of the indicia of success
` listed in the '214 patent have a
` safety requirement, correct?
` MR. STOPS: Objection,
` mischaracterizes the witness's
` testimony. Asked and answered.
` A. As I have said, I don't
` think physicians really would
` consider any treatment successful if
` the treatment weren't safe.
` Q. But the indicia of success
` explicitly recited in the '214
` patent are abatement, remission,
` diminishing of symptoms or making
` the pathology or condition more
` tolerable to the patient, slowing in
`
`800-642-1099
`
`David Feldman Worldwide
`A Veritext Company
`
`www.veritext.com
`
`33
`
`

`

`Page 34
`
`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
`
` F. PETER GUENGERICH
` the rates of degeneration or
` decline, making the final point of
` degeneration less debilitating or
` improving a patient's physical or
` mental well being. Those are
` indicia of a change or -- a change
` in the condition of the patient that
` would be an indication of success in
` the treatment to change a patient's
` condition or symptoms, correct?
` MR. STOPS: Objection.
` Mischaracterizes the document.
` Incomplete hypothetical.
` A. I don't think any of those
` things could be done without doing
` it safely.
` Q. So are you telling me that
` a patient cannot be treated for
` Cushing in order to achieve
` remission safely?
` MR. STOPS: Objection.
` Mischaracterizes the witness'

This document is available on Docket Alarm but you must sign up to view it.


Or .

Accessing this document will incur an additional charge of $.

After purchase, you can access this document again without charge.

Accept $ Charge
throbber

Still Working On It

This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.

Give it another minute or two to complete, and then try the refresh button.

throbber

A few More Minutes ... Still Working

It can take up to 5 minutes for us to download a document if the court servers are running slowly.

Thank you for your continued patience.

This document could not be displayed.

We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.

Your account does not support viewing this document.

You need a Paid Account to view this document. Click here to change your account type.

Your account does not support viewing this document.

Set your membership status to view this document.

With a Docket Alarm membership, you'll get a whole lot more, including:

  • Up-to-date information for this case.
  • Email alerts whenever there is an update.
  • Full text search for other cases.
  • Get email alerts whenever a new case matches your search.

Become a Member

One Moment Please

The filing “” is large (MB) and is being downloaded.

Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.

Your document is on its way!

If you do not receive the document in five minutes, contact support at support@docketalarm.com.

Sealed Document

We are unable to display this document, it may be under a court ordered seal.

If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.


Access Government Site

We are redirecting you
to a mobile optimized page.





Document Unreadable or Corrupt

Refresh this Document
Go to the Docket

We are unable to display this document.

Refresh this Document
Go to the Docket