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` UNITED STATES PATENT AND TRADEMARK OFFICE
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`BRECKENRIDGE PHARMACEUTICAL, )
`INC., )
` )
` Petitioner, )
` ) Case IPR2017-01592
` VS. ) Patent No. 8,410,131
` )
`NOVARTIS PHARMACEUTICALS )
`CORPORATION, )
` )
` Patent Owner. )
` )
`_____________________________)
`
` DEPOSITION OF ALLAN J. PANTUCK, MD
` Los Angeles, California
` Tuesday, March 13, 2018
`
`Job No. 138683
`Reported by: NIKKI ROY
` CSR No. 3052
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` UNITED STATES PATENT AND TRADEMARK OFFICE
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`BRECKENRIDGE PHARMACEUTICAL, )
`INC., )
` )
` Petitioner, )
` ) Case IPR2017-01592
` VS. ) Patent No. 8,410,131
` )
`NOVARTIS PHARMACEUTICALS )
`CORPORATION, )
` )
` Patent Owner. )
` )
`_____________________________)
`
` DEPOSITION OF ALLAN J. PANTUCK, MD
` Los Angeles, California
` Tuesday, March 13, 2018
`
`Job No. 138683
`Reported by: NIKKI ROY
` CSR No. 3052
`
`TSG Reporting - Worldwide 877-702-9580
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` Deposition of ALLAN J. PANTUCK, MD, taken on
`behalf of Patent Owner Novartis Pharmaceuticals
`Corporation, at Clark Urology Center, 200 UCLA
`Medical Plaza, Suite 140, Los Angeles, California,
`on Tuesday, March 13, 2018 at 8:01 a.m., before
`NIKKI ROY, CSR No. 3052.
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`APPEARANCES OF COUNSEL:
`
`FOR PETITIONER:
` MERCHANT & GOULD
` JEFFREY BLAKE, Esq.
` DANIEL EVANS, Ph.D., Esq.
` 191 Peachtree Street N.E.
` Atlanta, Georgia 30303
`
`FOR PATENT OWNER:
` FITZPATRICK, CELLA, HARPER & SCINTO
` CHARLOTTE JACOBSEN, Esq.
` SUSANNE FLANDERS, Esq.
` 1290 Avenue of the Americas
` New York, New York 10104
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` I N D E X
`
`WITNESS EXAMINATION PAGE
`ALLAN J. PANTUCK,
`MD
` MS. JACOBSEN 6, 135
` MR. BLAKE 275
`
` E X H I B I T S
`
`NUMBER DESCRIPTION PAGE
`Exhibit 2023 Chapter 78 Renal Cell 40
` Carcinoma, James M. Kozlowski,
` Bates-stamped ROX_EW_00149173
` through ROX_EW_00149183
`
`Exhibit 2024 Systemic Therapy for Renal 50
` Cell Carcinoma, Robert J.
` Motzer and Paul Russo
`
`Exhibit 2025 Physicians' Desk Reference, 86
` 2001
`Exhibit 2026 Blank sheet of paper 246
`Exhibit 1120 List of Exhibits with 283
` Paragraph Citations
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` I N D E X (CONTINUED):
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` QUESTIONS INSTRUCTED NOT TO ANSWER
` None
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` INFORMATION REQUESTED
` None
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` LOS ANGELES, CALIFORNIA, TUESDAY, MARCH 13, 2018
` 8:01 A.M.
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` ALLAN J. PANTUCK, MD
` called as a deponent and sworn in by
` the deposition officer, was examined
` and testified as follows:
`
` EXAMINATION
` BY MS. JACOBSEN:
` Q. Good morning, Dr. Pantuck.
` A. Good morning.
` Q. My name is Charlotte Jacobsen. I'm going to
` be asking the questions today.
` Have you been deposed before?
` A. Yes.
` Q. Approximately how many times?
` A. About a half dozen times.
` Q. And in any all of those depositions, have
` you been acting as an expert in the case?
` A. All cases was an expert.
` Q. Are any of those patent cases?
` A. No.
` Q. So you know the procedure, but I'll just go
` over some ground rules.
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` A. Okay.
` Q. You see we have a court reporter here, and
` she is going to be taking note of what we say. In
` order to get a clear record, we ask -- I ask that we
` try not to speak over each other, and I ask that you
` wait until I have finished my question before you
` start answering. And I will endeavor to wait until
` the end of your answer before I ask the next
` question; is that okay?
` A. That's okay.
` MR. BLAKE: And just add to that briefly,
` before you answer, give me an opportunity to render
` any objections to the questions.
` THE WITNESS: Okay.
` BY MS. JACOBSEN:
` Q. And if you don't understand any of my
` questions, can you ask me to rephrase them, please?
` A. I will.
` Q. And if you do not ask me to rephrase them,
` I'm going to assume that you understood the question;
` is that fair?
` A. That's fair.
` Q. And is there any reason why you cannot
` answer truthfully and to the best of your ability
` today?
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` A. No.
` Q. You have binders in front of you. Those
` contain all of the exhibits that were submitted by
` Breckenridge in the IPR proceeding. And I'll be
` referring to them by their exhibit number, which
` corresponds to their tab.
` Do you understand?
` A. Yes.
` MR. BLAKE: I'll just note for the record
` that the binders were provided and they appear to be
` complete, but obviously Dr. Pantuck hasn't had an
` opportunity to look through them to confirm that all
` the exhibits are there. And we'll take you at your
` word for that.
` BY MS. JACOBSEN:
` Q. If there appears to be anything missing or
` anything incomplete or improperly copied, then please
` let me know and we'll deal with that. Okay.
` I'd like to start by looking at your
` declaration. I see you've taken that out. So that's
` Exhibit 1010.
` So do you have that, Dr. Pantuck?
` A. I do.
` Q. And have you had an opportunity to look at
` this copy of that document? Does it appear to be a
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` complete and accurate copy of your declaration that
` you submitted in these IPR proceedings?
` MR. BLAKE: If you'll take just a moment to
` look through it, Doctor.
` (Document reviewed by witness.)
` THE WITNESS: Appears to be complete.
` BY MS. JACOBSEN:
` Q. Okay. Can you turn to paragraph 20 on
` page 8?
` A. Okay.
` Q. And here you set forth your understanding,
` your definition of a person of ordinary skill in the
` art or a POSA; is that right?
` A. That's correct.
` Q. And is that whose perspective you rendered
` your opinions in this case regarding the validity or
` invalidity of the '131 patent?
` A. Yes.
` Q. Okay. And in your view, a POSA would have
` had knowledge of oncology drug development; is that
` right?
` A. Yes.
` Q. Would the POSA have had knowledge of
` oncology drug development related to any other class
` of drug other than the rapamycin analogs?
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` MR. BLAKE: Objection to form.
` THE WITNESS: I think oncology drug
` development would include that, but it would be
` broader.
` BY MS. JACOBSEN:
` Q. So it would be broader.
` What other class or classes of drugs would
` the POSA have had experience with?
` A. Well, drugs in oncology related to their
` specialty.
` Q. And when you say "related to their
` specialty," what do you mean?
` A. Useful for treating tumors within their
` practice.
` Q. And can you give me any examples of drugs in
` oncology related to their speciality that a person of
` ordinary skill in the art would have had knowledge
` of, according to your definition of a POSA?
` A. I mean, the entire spectrum of oncology
` drugs, sunitinib would be one example of a drug
` relevant for treating kidney cancer.
` Q. And is it your opinion that a person of
` ordinary skill in the art as of either February 18,
` 2001, or February 18, 2002, would have had knowledge
` of sunitinib?
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` A. Yes.
` Q. Okay. And when you say "relevant to
` treating kidney cancer," is it your opinion that a
` person of ordinary skill in the art would have been
` interested in drugs relating to types of cancer other
` than kidney cancer?
` MR. BLAKE: Objection to form.
` THE WITNESS: Kidney cancer is just one type
` of cancer. So a specialist in oncology would have
` been interested in more than one tumor type.
` BY MS. JACOBSEN:
` Q. And what other types of tumor would your
` POSA have been interested in?
` A. So I'm a urologic oncologist. I would
` specialize in and have skill related to genitourinary
` tumors. Those are tumors of the urinary and
` reproductive systems.
` Q. Other than sunitinib, can you give me any
` other examples of classes or -- strike that.
` Other than sunitinib, can you give me any
` other examples of drugs or classes of drugs that your
` POSA would have had experience with as of February
` 2001 or February 2002?
` A. So sorafenib would be another example.
` Q. Others?
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` A. Everolimus would be another example.
` Q. Any others?
` A. Cytokine therapy would be another example.
` Q. What is cytokine therapy?
` A. Administration of biologic modifiers, things
` that affect the immune system.
` Q. What do you mean by "affect the immune
` system"?
` A. That impact the immune system, either
` inhibit it or augment it. Affect its activity.
` Q. Can you give me an example of a biological
` modifier that inhibited the immune system that a
` person of ordinary skill in the art would have been
` aware of as of February 2001 or February 2002?
` A. Well, mTOR inhibitors, for example.
` Q. Any others?
` A. That's the only thing that comes to mind
` right now.
` Q. Can you give me any examples of drugs or
` classes of drugs that augmented the immune system
` that a person of ordinary skill in the art would have
` been aware of as of February 2001 or February 2002?
` A. Well, interleukin-2 and interferon alpha
` would be two.
` Q. And when you say "augment," is that the same
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` as stimulate?
` A. Yes.
` MR. BLAKE: Doctor, I'll ask you just to
` make sure she finishes the question before you
` answer.
` THE WITNESS: Okay.
` MR. BLAKE: Makes it easier for the court
` reporter.
` BY MS. JACOBSEN:
` Q. Okay. So we've discussed sunitinib,
` sorafenib, everolimus, cytokine therapy and mTOR
` inhibitors.
` Are there any other drugs or classes of
` drugs that a POSA would have had experience with as
` of February 2001 or February 2002?
` A. Well, there were other experimental
` therapeutics being tested at the time.
` Q. Can you give me any examples?
` A. For example, EGFR inhibitors.
` Q. Any others?
` A. That's the only one that I can think of at
` the moment.
` Q. When you say they were -- they were being
` tested at the time, what do you mean by they were
` "being tested at the time"? Is that clinical
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` development?
` A. Well, it could be either preclinical or
` clinical.
` Q. And as of February 2001 or February 2002,
` were EGFR inhibitors in clinical or preclinical
` development?
` A. Both.
` Q. And for what type of cancer?
` A. Multiple cancer types.
` Q. Including any urinary system cancers?
` A. Including kidney cancer.
` Q. You mentioned sunitinib and sorafenib. Do
` they belong to one class of drug or different classes
` of drug?
` A. They're both considered targeted therapies
` that are receptor tyrosine kinase inhibitors.
` Q. Would a POSA have had specific experience in
` the treatment of solid excretory system tumors of the
` urinary system including kidney tumors and RCC?
` A. Yes.
` Q. And you haven't -- looking back at your
` definition of a POSA in paragraph 20, you haven't a
` specifically alleged that a POSA would have had
` experience with mTOR inhibitors; is that right?
` MR. BLAKE: Objection to form.
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` THE WITNESS: I mean, the description
` doesn't explicitly mention mTOR inhibitors, but mTOR
` inhibitors were relevant at the time. And they're
` part of -- they're subsumed in my description of
` oncology drug development.
` BY MS. JACOBSEN:
` Q. Okay. So is it your opinion that a person
` of ordinary skill in the art would have had specific
` experience with mTOR inhibitors as of either February
` 2001 or February 2002?
` MR. BLAKE: Objection as to form,
` mischaracterizes his testimony.
` THE WITNESS: I would say experienced
` delivering them, not necessarily, but awareness of
` them, awareness of their mechanism of action,
` awareness of their potential applications.
` BY MS. JACOBSEN:
` Q. And what about all the other drugs that we
` discussed before, sunitinib, sorafenib, cytokine
` therapy, and the other experimental therapies such as
` EGFR inhibitors; are they also subsumed within your
` definition of a POSA having experience with oncology
` drug development?
` A. They're all examples.
` Q. Okay. So a person of ordinary skill in the
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` art as of February 2001 or February 2002 would not
` have just had experience with mTOR inhibitors, they
` would have also had experience with all the other
` types of drugs that we discussed, the sunitinib,
` sorafenib, cytokine therapy and experimental therapy
` such as EGFR inhibitors?
` MR. BLAKE: Objection to form, calls for
` speculation as to all other types of drugs.
` THE WITNESS: Well, I would agree with the
` drugs that we discussed.
` MS. JACOBSEN: And, Counsel, there are
` strict rules on the appropriate objections in IPR
` proceedings, and you're intended to only say a single
` word rather than coach the witness. So I add that
` ask that you adhere to that in your objections.
` MR. BLAKE: Counsel, I've done plenty of IPR
` proceedings, and I know what the rules are. I'm
` entitled to state the basis for my objection.
` BY MS. JACOBSEN:
` Q. And is it your position that a POSA would
` have been specifically working in the field of mTOR
` inhibition?
` A. I don't believe they would have specifically
` had to work in that field.
` Q. Okay. So is it fair to say a POSA would
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` have been working in the field of oncology and
` specifically developing new drugs for the treatment
` of solid excretory system tumors of the urinary
` excretory system?
` A. Would you repeat the question?
` Q. Sure.
` Is it fair to say that a POSA would have
` been in working in the field of oncology and
` specifically developing new drugs for the treatment
` of solid tumors of the urinary excretory system?
` MR. BLAKE: Objection to form.
` THE WITNESS: What I've written is knowledge
` of the development. They wouldn't necessarily have
` to be working in the area of the development but have
` an awareness and knowledge of it.
` BY MS. JACOBSEN:
` Q. Okay. So a person -- is it fair to say that
` a person of ordinary skill in the art would have
` either have been working in the field or have
` knowledge of the field of oncology and specifically
` developing new drugs for the treatment of solid
` tumors of the urinary excretory system?
` A. Yes.
` MR. BLAKE: And I'll raise an objection.
` And, again, give me an opportunity --
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` THE WITNESS: Okay.
` MR. BLAKE: -- to answer.
` BY MS. JACOBSEN:
` Q. Thank you.
` You've not alleged that a POSA would have
` had years of specific experience in the field of
` transplantation, right?
` A. No.
` Q. No, you have not -- sorry. That's -- I'll
` rephrase the question so that it's clear.
` You're not alleging that a POSA would have
` had several years of specific experience in the field
` of transplantation; are you?
` A. No, I'm not.
` Q. And you're not alleging that a POSA would
` have had several years of specific experience in the
` field of immunosuppression?
` MR. BLAKE: Objection to form,
` mischaracterizes his testimony.
` THE WITNESS: Immunosuppression, to the
` degree that it overlapped with the specialty of
` oncology I think would be part of the relevant
` knowledge.
` BY MS. JACOBSEN:
` Q. And to what extent did it overlap?
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` A. Well, there are drugs that have
` antiproliferative effects that may impact both tumor
` growth and the immune function, so that would be
` relevant.
` Q. What drugs are those?
` A. For example, the mTOR inhibitors.
` Q. Are there any other classes of drugs that
` impact both tumor proliferation and the immune system
` that a person of ordinary skill in the art would have
` been aware of other than mTOR inhibitors?
` A. None that I can think of at the moment.
` Q. So you've not alleged that a POSA would have
` had knowledge of immunosuppressive drugs other than
` mTOR inhibitors, right?
` MR. BLAKE: Objection to form,
` mischaracterizes his testimony.
` THE WITNESS: mTOR inhibitors are the one
` example I can think of at the moment.
` BY MS. JACOBSEN:
` Q. What was the problem that the POSA was
` trying to solve in 2001 or 2002?
` A. I don't understand your question.
` Q. Was there a problem in the field that a
` person of ordinary skill in the art would have been
` working to try and solve as of February 2001 or 2002?
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` A. The person --
` MR. BLAKE: Objection to form.
` THE WITNESS: The person with ordinary skill
` in the art would have been working towards finding
` new therapies capable of inhibiting the growth of
` solid excretory system tumors.
` BY MS. JACOBSEN:
` Q. So the POSA wasn't looking for new drugs for
` immunosuppression?
` MR. BLAKE: Objection to form.
` THE WITNESS: I said they would be looking
` for drugs capable of inhibiting the growth of solid
` excretory tumors and that a drug may have additional
` immunosuppressive effects, but the focus would be on
` the growth of tumors.
` BY MS. JACOBSEN:
` Q. The goal of a person of ordinary skill in
` the art would not have been to be suppressing or
` inhibiting the immune system of the patient, correct?
` MR. BLAKE: Objection to form,
` mischaracterizes the testimony.
` THE WITNESS: The goal would be to find
` treatments capable of inhibiting the growth of solid
` excretory system tumors.
` ///
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` BY MS. JACOBSEN:
` Q. And all solid excretory system tumors or any
` specific one in particular?
` A. There are many types subsumed in that
` category.
` Q. So is a person of ordinary skill in the art
` looking for a new safe and effective treatment for
` the advanced renal cell carcinoma?
` A. Potentially.
` Q. The person of ordinary skill in the art
` wasn't looking for new drugs for transplantation
` rejection, correct?
` MR. BLAKE: Objection to form,
` mischaracterizes the testimony.
` THE WITNESS: A person skilled in the arts
` of oncology would not be looking for -- I'm sorry.
` Would you rephrase your question?
` BY MS. JACOBSEN:
` Q. So the person of ordinary skill in the art
` was not looking for new drugs to treat transplant
` patients, correct?
` A. Well, transplant patients can have cancers
` as well. So, again, they're overlapping fields, so
` they're not mutually exclusive.
` Q. All right. So the person of ordinary skill
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` in the art was not looking for new drugs for the
` prevention of transplant rejection?
` A. Correct.
` Q. And the person was not looking for new
` treatments for post-transplant lymphoproliferative
` disorders, correct?
` A. The person skilled in the art would be
` looking for treatments that are capable of inhibiting
` the growth of a solid excretory system tumor. And if
` there are additional benefits of those drugs, that
` would be relevant.
` Q. Right. But the goal of the POSA is not to
` develop a new treatment for post-transplant
` lymphoproliferative disorder, right?
` MR. BLAKE: Objection to form, asked and
` answered.
` THE WITNESS: Yeah. I believe I've answered
` it. But the goal would be to find a treatment for
` inhibiting the growth of a solid excretory system
` tumor.
` BY MS. JACOBSEN:
` Q. And not to develop a treatment specifically
` for post-transplant lymphoproliferative disorders,
` correct?
` MR. BLAKE: Objection to form, asked and
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` answered multiple times now.
` THE WITNESS: There could be overlapping
` benefits of drugs. So a drug that is capable of
` inhibiting the growth of an excretory system tumor
` may have additional benefits in terms of inhibiting
` the immune system or inhibiting post-transplant
` lymphoproliferative disorders. So to the extent that
` they're related, that would be relevant.
` BY MS. JACOBSEN:
` Q. Right. But not all drugs that treat
` post-transplant lymphoproliferative disorders also
` treat solid excretory system tumors, correct?
` MR. BLAKE: Objection to form, calls for
` speculation.
` THE WITNESS: Correct.
` BY MS. JACOBSEN:
` Q. And so a person of ordinary skill in the art
` would not reasonably expect that just because a drug
` treated a post-transplant lymphoproliferative
` disorder, it would also treat a solid excretory
` system tumor, correct?
` MR. BLAKE: Objection to form.
` THE WITNESS: It would depend on the
` mechanism of action of the drug.
` ///
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` BY MS. JACOBSEN:
` Q. A person of ordinary skill in the art would
` not reasonably expect that all drugs that treat
` post-transplant lymphoproliferative disorders would
` also treat solid excretory system tumors, correct?
` A. It's hard to talk about all drugs, but not
` all drugs that do one do the other. Some do both.
` Q. And when you say "do one do the other," do
` you mean treat post-transplant lymphoproliferative
` disorders and treat solid excretory system tumors,
` right?
` A. Correct.
` Q. And you agree that the goal of the person of
` ordinary skill in the art would not have been the
` additional benefit that you were talking about in
` terms of treating post-transplant lymphoproliferative
` disorders, the goal of the POSA would be to treat
` solid excretory system tumors, correct?
` MR. BLAKE: Objection to form.
` THE WITNESS: I'm not sure I can answer you
` exactly. Rephrase the question.
` BY MS. JACOBSEN:
` Q. I'm sorry. We can move on.
` A person of ordinary skill in the art was
` not looking for new treatments for lymphomas, right?
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` A. Well, lymphoma is one type of kidney tumor,
` so potentially yes.
` Q. And lymphoma is a type of solid excretory
` system tumor?
` A. They're considered liquid tumors.
` Q. So it's your -- in your opinion, is the POSA
` looking for a new treatment for solid excretory
` system tumors or all excretory system tumors?
` A. A tumor can be solid or liquid. So all
` tumors of the excretory system would be relevant.
` Q. Including both solid and liquid tumors in
` your opinion?
` A. Yes.
` Q. You said solid and liquid tumors of the
` excretory system tumor would be relevant. Relevant
` to what?
` A. To the development of drugs that are capable
` of inhibiting their growth.
` Q. Dr. Pantuck, how did you identify the prior
` art references that you relied are in this IPR?
` A. The majority of the prior art references
` were given to me by counsel.
` Q. Did you identify any of the references
` yourself?
` A. I did.
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` Q. And do you recall which references you
` identified yourself?
` A. I don't recall every one.
` Q. Do you recall any of them?
` A. Exhibit 41 is one example.
` MR. BLAKE: I'll note for the record while
` he's looking for that, that we've provided
` Dr. Pantuck with an appendix that lists the exhibits
` in his declaration and where they're located in the
` declaration so he can use that to reference and find
` information. And counsel agreed prior to the
` deposition that we'll find the appropriate exhibit
` number to mark this appendix so that we can reference
` it in the future.
` BY MS. JACOBSEN:
` Q. So Exhibit 1041, is that the Perez-Atayde
` reference? If you --
` A. Let's see. Yes.
` Q. Do you recall identifying any other
` references yourself?
` A. That's the only one that I can recall at the
` moment.
` Q. Do you believe that you identified more than
` just Exhibit 1041?
` A. I don't recall.
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` Q. And did you conduct any literature searches?
` A. Well, in order to find this particular
` reference I had to do a literature search, so yes.
` Q. Okay. And do you recall what terms you used
` in order to identify references?
` A. Terms would have included -- I mean, I'm
` just speculating. Honestly, I don't recall the exact
` terms I used. I believe renal cell carcinoma, mTOR
` inhibitors.
` Q. And do you recall any other terms that you
` believe you would have used?
` A. I don't recall.
` Q. And why did you include mTOR inhibitors in
` the search terms that you used to search for
` literature references?
` A. Because this -- the patent in question
` involves an mTOR inhibitor.
` Q. Any other reasons?
` A. No.
` Q. Can we go back to your declaration. It's on
` page 73. You with me, Dr. Pantuck?
` A. I'm with you.
` Q. Actually, I'm not there yet, so just bear
` with me. Okay.
` So this is where you start Section 10, is
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` that right, your expert declaration?
` A. Correct.
` Q. And that is the "prior art relied upon."
` You see that?
` A. Yes.
` Q. Okay. And can we assume for these questions
` and going forward that when I talk about solid
` excretory system tumors, I'm talking about solid
` tumors of the urinary excretory system. Is that
` okay?
` Can we proceed on that basis?
` A. I think that's reasonable.
` Q. Okay. And if either of us are using that
` term in a different way, we will make it clear to the
` other.
` A. Okay.
` Q. Is that fair?
` A. Yes.
` Q. Okay. So the -- in this section you
` discuss the main prior art references that you rely
` on or the prior art search -- strike that.
` In this section you discuss the prior art
` that you relied on in your grounds of invalidity; is
` that right?
` MR. BLAKE: Dr. Pantuck, feel free to take a
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` moment to look through the section.
` Are you just -- are you talking about all of
` Section 10?
` MS. JACOBSEN: I am, yes.
` BY MS. JACOBSEN:
` Q. Dr. Pantuck, I see you're looking at the
` table of contents Roman II.
` A. Yes.
` Q. And you can see that prior art relied upon
` Section 10 includes Schuler, Crowe, Neumayer,
` Alexandre, Hidalgo, Luan, Wasik, and Navarro.
` A. Yes.
` Q. You see that?
`
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