`
`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
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`800-642-1099
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`David Feldman Worldwide
`A Veritext Company
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`www.veritext.com
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`TEVA1070
`Teva Pharmaceuticals USA, Inc. v. Corcept Therapeutics, Inc.
`PGR2019-00048
`
`
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`Page 2
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` 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.
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`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
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` 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
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` 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
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` 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
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` 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
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` 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
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` 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
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` 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
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` 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.
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` 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.)
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` 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
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` 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
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` 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
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` 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
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` 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
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` 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
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` 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
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` 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
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` 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
`
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`
`David Feldman Worldwide
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` 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
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` 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.
`
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` 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
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` 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
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` 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
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`David Feldman Worldwide
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` 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.
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` 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.
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` 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.
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` 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?
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` 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
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` 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
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` 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
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` 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'