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`Page 1
`UNITED STATES PATENT AND TRADEMARK OFFICE
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`__________________________________________X
`CELLTRION, INC.,
` Petitioner, Case IPR-2017-01121
` Patent No. 7,846,441
` Case IPR-2017-01122
` Patent No. 7,892,549
`V.
`
`GENENTECH, INC.,
` Patent Owner.
`___________________________________________X
` C O N F I D E N T I A L
` Videotaped Deposition of
` DR. SUSAN TANNENBAUM, M.D.
` Thursday, March 7, 2018
` 9:12 a.m.
`
`Wilmer Cutler Pickering Hale and Dorr LLP
` 7 World Trade Center
` New York, New York
`
`Mark Richman, CSR, CM
`Registered Professional Reporter
`
`212-279-9424
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`www.veritext.com
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`212-490-3430
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`Page 1
`UNITED STATES PATENT AND TRADEMARK OFFICE
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`__________________________________________X
`CELLTRION, INC.,
` Petitioner, Case IPR-2017-01121
` Patent No. 7,846,441
` Case IPR-2017-01122
` Patent No. 7,892,549
`V.
`
`GENENTECH, INC.,
` Patent Owner.
`___________________________________________X
` C O N F I D E N T I A L
` Videotaped Deposition of
` DR. SUSAN TANNENBAUM, M.D.
` Thursday, March 7, 2018
` 9:12 a.m.
`
`Wilmer Cutler Pickering Hale and Dorr LLP
` 7 World Trade Center
` New York, New York
`
`Mark Richman, CSR, CM
`Registered Professional Reporter
`
`212-279-9424
`
`Veritext Legal Solutions
`www.veritext.com
`
`212-490-3430
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`Page 2
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` SUSAN TANNENBAUM (CONFIDENTIAL)
`
` March 7, 2018
` 9:12 a.m.
`
` Video Recorded Deposition of SUSAN
`TANNENBAUM, taken by Petitioner, at the
`offices of Wilmer Cutler Pickering Hale
`and Dorr LLP, 7 World Trade Center, New
`York, New York, before Mark Richman, a
`Certified Shorthand Reporter, Registered
`Professional Reporter and Notary Public
`within and for the State of New York
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` SUSAN TANNENBAUM (CONFIDENTIAL)
`A P P E A R A N C E S:
`
`GOODWIN PROCTER LLP
`Attorneys for Petitioner
` The New York Times Building
` 620 Eighth Avenue
` New York, New York 10018
`
`BY: ROBERT V. CERWINSKI, ESQ.
` rcerwinsky@goodwinlaw.com
`
`WILMER CUTLER PICKERING HALE and DORR LLP
`Attorneys for the Patent Owner & Witness
` 60 State Street
` Boston, Massachusetts 02109
`
`BY: ANDREW J. DANFORD, ESQ.
` andrew.danford@wilmerhale.com
`
`ALSO PRESENT:
`Ron Marrazzo, Videographer
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` SUSAN TANNENBAUM (CONFIDENTIAL)
` THE VIDEOGRAPHER: Good morning.
` We are going on the record at
` approximately 9:12 a.m. It is March
` 7, 2018.
` Please note that the microphones
` are sensitive and may pick up
` whispering, private conversations and
` cellular interference. Please turn off
` all cellphones or place them away from
` the microphones as they can interfere
` with the deposition audio. Audio and
` video recording will continue to take
` place unless all parties agree to go
` off the record.
` This is media unit 1 of the
` video recorded deposition of Susan
` Tannenbaum, MD, in the matter of
` Celltrion, Incorporated, Petitioner,
` versus Genentech, Incorporated, Patent
` Owner, Case IPR2017-01121.
` This deposition is being held at
` WilmerHale located at 7 World Trade
` Center in New York City.
` My name is Ron Marrazzo,
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` SUSAN TANNENBAUM (CONFIDENTIAL)
` representing Veritext Legal Solutions,
` and our court reporter is Mark
` Richman, representing Veritext Legal
` Solutions. I'm not related to any
` party in this action nor am I
` financially interested in the outcome.
` Counsel and all present in the
` room and everyone attending remotely
` will now state their appearances and
` affiliations for the record.
` MR. CERWINSKI: Robert
` Cerwinski, Goodwin Procter LLP,
` counsel for the Petitioner, Celltrion.
` MR. DANFORD: Andrew Danford of
` WilmerHale, for the Patent Owner,
` Genentech, and the witness.
` THE VIDEOGRAPHER: Very good.
` We can now swear in the witness and
` proceed.
` SUSAN TANNENBAUM, having been
` first duly sworn by the Notary Public
` (Mark Richman), was examined and
` testified as follows:
` MR. CERWINSKI: So one
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` SUSAN TANNENBAUM (CONFIDENTIAL)
` correction for the record. This
` deposition is proceeding both in case
` IPR-2017-01121, which concerns U.S.
` Patent Number 7,846,441, as well as
` case number IPR-2017-01122, which
` concerns U.S. Patent 7,892,549.
` We all have that understanding?
` MR. DANFORD: Yes.
` MR. CERWINSKI: Okay, great.
` EXAMINATION BY MR. CERWINSKI:
` Q. Good morning, Dr. Tannenbaum.
` A. Good morning.
` Q. Thank you for being here on such
`a stormy day. I'm Rob Cerwinski, I
`represent the Petitioner, Celltrion. I'll
`be asking you questions today.
` Before we begin discussion of
`the substance of your declarations, I just
`wanted to go over any prior experience
`you've had at depositions. Can you
`briefly describe that experience?
` A. Yes.
` Q. Have you ever had your
`deposition taken before?
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` SUSAN TANNENBAUM (CONFIDENTIAL)
` A. Yesterday was my first.
` Q. Okay. Have you ever been
`involved in any patent infringement
`litigation before?
` A. I have not.
` Q. Okay. What did you do to
`prepare for your deposition today?
` A. I met with the attorneys, had
`conversations reviewing my declaration and
`reviewing any questions that I might have.
`That's, you know, reviewed my declaration,
`reviewed some of the materials but not all
`the materials.
` Q. Do you recall specific documents
`that you reviewed?
` A. Most importantly, my
`declaration. I also reviewed the
`documents that are written in the
`declaration as to the exhibits,
`specifically the ones Celltrion put
`forward for the patent case.
` Q. Do you recall reviewing any
`documents that weren't cited in your
`declaration or the declarations of the
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` SUSAN TANNENBAUM (CONFIDENTIAL)
`Celltrion witnesses?
` A. I did not.
` Q. When you say you met with the
`attorneys, who did you meet with?
` A. I met with Nora Passamaneck and
`with Andrew Danford.
` Q. And where did you meet?
` A. We met In West Hartford,
`actually it was Farmington, at -- where I
`work.
` Q. And when did you meet?
` A. Just met the Sunday before, this
`past Sunday.
` Q. Okay. And for approximately how
`long did you meet?
` A. About three hours.
` Q. Three hours, okay. And I
`understand you had your deposition taken
`yesterday?
` A. Yes.
` Q. Okay. And did you meet with
`counsel after that deposition?
` A. We had dinner together. We
`talked about some general --
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` SUSAN TANNENBAUM (CONFIDENTIAL)
` MR. DANFORD: Don't reveal the
` substance of the conversations.
` A. -- nervousness issues, but
`nothing of really any substance.
` Q. Did you do any preparation for
`today's deposition last night?
` A. I actually did not. I just went
`to sleep.
` Q. Okay. Did you, did you look at
`a transcript of yesterday's deposition?
` A. I did not.
` Q. And between the time your
`deposition concluded yesterday and today,
`did you review any documents in connection
`with your work in the case?
` A. This morning before I came in I
`just looked at my declaration again.
` Q. Okay. If we can, I'm going to
`put in front of you your declarations. So
`these have previously -- so your
`declarations in both the 1121 and 1122
`IPRs, and these have previously been
`marked as exhibits. Your declaration in
`the 1121 case is, has been marked as
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` SUSAN TANNENBAUM (CONFIDENTIAL)
`Genentech 2062 and your declaration in the
`1122 case has also confusingly been marked
`as Genentech 2062. I'm really only going
`to be focused, I should say I will
`primarily be focused on the declaration in
`the '441 Patent case and I think for
`convenience can we agree I'll just refer
`to that declaration and that IPR as your
`declaration in the '441 case and that case
`as the '441 IPR. Is that okay?
` A. That's fine.
` Q. Okay. Do you understand what I
`mean by the '441 Patent?
` A. I do.
` Q. Okay, great. So here, that can
`be your copy.
` (Exhibit Genentech 2062, in 1121
` case, previously marked and shown to
` witness.)
` (Exhibit Genentech 2062, in 1122
` case, previously marked and shown to
` witness.)
` Q. And this is the declaration from
`the '549 Patent case. Here you go. And
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` SUSAN TANNENBAUM (CONFIDENTIAL)
`why don't I just go ahead and put in front
`of you the two patents at issue in these
`cases. So I'll also put in front of you
`U.S. Patent 7,846,441, that's been marked
`in the '441 IPR as exhibit 1001.
` A. Thank you.
` Q. And I'll also put in front of
`you a copy of U.S. Patent 7,892,549 which
`has been marked in the '549 IPR as exhibit
`1001.
` (Exhibit IPR 1001, U.S. Patent
` 7,846,441, in the '441 IPR, previously
` marked and shown to witness.)
` (Exhibit IPR 1001, U.S. Patent
` 7,892,549, in the '549 IPR, previously
` marked and shown to witness.)
` Q. And if you can just flip through
`what I've put in front of you as your
`declaration in the '441 Patent IPR,
`Genentech 2062, just verify that that's a
`copy of your declaration submitted in that
`case?
` A. Yes.
` Q. And can you do the same thing
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` SUSAN TANNENBAUM (CONFIDENTIAL)
`for your declaration submitted in the '549
`Patent case, which has been marked in that
`case as Genentech 2062. Is that your
`declaration from that case?
` A. It is.
` Q. Okay. So turning to your
`declaration in the '441 Patent case, I
`understand that you reviewed this
`declaration in preparation for your
`deposition today, correct?
` A. I looked at it for about a half
`hour, yes.
` Q. Okay. To your knowledge,
`sitting here today, is it a -- do you have
`any corrections to make to this
`declaration?
` A. I made corrections yesterday and
`the same corrections today. My years at
`Wilshire Oncology started not in the
`declaration it says in 2017, but it was
`the end November of 2016, as stated in my
`CV.
` The other was --
` MR. DANFORD: Just to clarify.
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` SUSAN TANNENBAUM (CONFIDENTIAL)
` Do you mean 2017?
` THE WITNESS: I'm sorry, I'm
` sorry, I'm sorry.
` A. Okay. I need to go back a
`little bit.
` Q. Please do. Take your time.
` A. 1996 instead of 1997.
` Q. Okay.
` A. And then once in here I used the
`word brain instead of breast when
`describing the cancer. So those are the
`only corrections that I found.
` Q. Okay. And same question with
`respect to your declaration in the '549
`Patent case, are there any corrections
`that you want to make with respect to that
`declaration?
` A. No, just the same with the CV
`and the dates.
` Q. Okay, great. Now let's talk a
`little bit about how you went about
`producing these two declarations. Who
`drafted the initial draft of these
`declarations?
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` SUSAN TANNENBAUM (CONFIDENTIAL)
` A. So I spent a lot of time alone
`and with Nora and Andrew reviewing data
`that I had gathered and we drafted it
`together. They put it to pen. It was all
`my words.
` Q. Did they produce the first
`draft?
` A. They created the document, yes.
` Q. Okay. They created the first
`draft and sent you that draft?
` A. Right. I reviewed multiple
`drafts and made multiple corrections.
` Q. Okay. And prior to commencing
`your work on the case, did the lawyers
`give you any information? I should say --
`strike that.
` At the outset, before you
`actually did any of your own work in the
`case, did the lawyers send you any
`information or materials?
` A. They didn't send me anything. I
`met with them for a first meeting in May
`of last year, 2017, and at that point they
`gave me information regarding the patent
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` SUSAN TANNENBAUM (CONFIDENTIAL)
`and helped me to understand what patent
`law is all about, what issues are because
`I had never been involved in this before.
` Q. Okay. Did they send you any of
`the papers in either of the cases?
` A. I believe I received the papers
`which were created by the petitioners, in
`other words, the Baselga papers, the
`papers specifically referred to in the, in
`the petitioner's. And I guess I got, I
`assume that I got -- I'm not sure when I
`got it, but I then got what the, what the
`questions at hand were from the
`petitioner.
` Q. What do you mean by the
`questions at hand?
` A. I mean the petitioner's --
`sorry, I'm having a little trouble this
`morning. I'll get to it. The
`petitioner's -- the -- the -- what the
`petitioner submitted to argue against the
`patent.
` Q. Okay.
` A. I'm not sure what you call that.
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` SUSAN TANNENBAUM (CONFIDENTIAL)
` Q. So the petition itself?
` A. Yes.
` Q. And did you receive that
`petition before you commenced any work?
` A. I did not.
` Q. Okay. About when in the course
`of your work did you receive a copy of
`that petition?
` A. I just don't remember.
` Q. Okay. And I take it you
`received copies of the petitions in both
`cases, the '549 and the '441 Patent cases?
` A. Yes.
` Q. Okay. Did you receive them
`about the same time?
` A. I don't, I don't recall, to be
`honest.
` Q. Did you receive any declarations
`at the time you received the petitions?
` A. I did not.
` Q. Okay. Did you receive any -- I
`take it you've looked at Dr. Earhart's
`declaration in this case, correct?
` A. Yes, much later, yes.
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` SUSAN TANNENBAUM (CONFIDENTIAL)
` Q. Okay. About when did you
`receive that?
` A. It was clearly before my
`declaration was written that I had an
`opportunity to review that, but I honestly
`don't recall the timing.
` Q. Do you recall whether it was
`near the beginning of your, your work in
`this case or closer to the end --
` A. Somewhere in the middle.
` Q. -- when you were --
` A. Sorry, I didn't mean to
`interrupt.
` Q. That's okay.
` A. Apologize.
` Q. And prior to -- and so did you
`receive any -- strike that question.
` I believe you said that you
`received some of the documents that were
`cited in the IPR papers; is that correct?
` A. The IPR is the petitioner's.
` Q. Yes.
` A. Yes, all right.
` Q. The petitioner's; is that right?
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` SUSAN TANNENBAUM (CONFIDENTIAL)
` A. Yes, yes, the one specifically
`mentioned that would, that were used in
`their documents, yes.
` Q. Okay. So you received copies of
`the prior art references and other
`references that were referred to in the
`petitions; is that right?
` A. I think it was mainly the three
`main references.
` Q. Okay. And did you receive any
`of the documents that were referenced in
`the Earhart declaration?
` A. I don't think so. I think I
`just received the declaration.
` Q. Okay. And did you look at any
`other declarations --
` A. I mean I -- could I clarify?
` Q. Sure, please.
` A. I think I received things later
`on but not earlier.
` Q. When you say later on, was that
`prior to submitting your declaration?
` A. Yes.
` Q. Okay.
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` A. Yes.
` Q. So when you mean later on, when
`you say later on, what do you mean?
` A. So everything was -- everything
`that I reviewed was before my declaration.
`And so I didn't do anything -- I just
`re-reviewed things after that, okay, so
`there was no new information.
` The information, I was sent a
`lot of the data, a lot of the papers,
`reviewed them throughout, had not -- at
`the same time I received them prior to
`making my declaration.
` Q. At any time prior to submitting
`your declarations, did you conduct any of
`your own searches for prior art or
`scientific references?
` A. Yes, I did.
` Q. And can you tell me the
`circumstances of that?
` A. Well in reading the papers that
`were submitted to me, it raised many
`questions. When did things happen? How
`did things happen? Where did things
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` SUSAN TANNENBAUM (CONFIDENTIAL)
`happen? And so I fortunately work at a
`medical center and we have our library
`easily online accessed and I did a lot of
`looking into those specifics, references
`from references.
` Q. And, you know, where in the
`process did you actually conduct that
`searching?
` A. All throughout until my
`declaration was completed.
` Q. Okay. Do you recall -- you cite
`a number of references in your
`declarations. Do you recall which ones
`you located versus which ones the lawyers
`located?
` A. The lawyers only gave me the
`ones that were referenced in the IPR and
`some that might have been referenced in
`the patent, but certainly not all, and all
`the others were mine.
` Q. Okay. Let's go back to the
`process of drafting the declaration. So
`were there certain sections in your
`declarations that the lawyers were
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` SUSAN TANNENBAUM (CONFIDENTIAL)
`principally responsible for drafting
`versus you?
` A. No.
` Q. So you're not a lawyer, right?
` A. I am not.
` Q. So if you can turn to your '441
`Patent declaration. If you look at page,
`right, you see there's a section here
`Legal Principles on Obviousness?
` A. Right.
` Q. Or at least those sections came
`from the lawyers, correct?
` A. So, yes, these sections came
`from the lawyers and the language in here
`is not my language in many respects in
`terms of the legal language. I don't
`understand much of legal language. But
`the content is all mine and I fully
`understand all this as we discussed it.
` Q. But at least these sections,
`paragraphs 15 through 21, the lawyers
`drafted those, correct?
` A. As I said, they put this to pen,
`yes, and they drafted the language
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` SUSAN TANNENBAUM (CONFIDENTIAL)
`appropriately. And all of this, in other
`words, I have been informed, you know, in
`undertaking the analysis, these are all my
`words, my content drafted with their
`words.
` Q. Okay. And was there any -- were
`there any other sections of these
`declarations that the lawyers put
`together?
` A. Not really. The major section
`that I relied on a colleague was in some
`of the preclinical data when I reviewed
`Dr. Kerbel's declaration. That was later.
`But in some of that, I'm just saying I
`relied on his input to some degree, but
`not directly because I never spoke with
`him.
` So many of, many of -- most of
`the, you know, again, this is all my words
`as I put it together and they wrote it in
`a language that made sense for a
`declaration, I guess. And they helped me
`understand all the concepts of the legal
`terms that are actually put in here.
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` SUSAN TANNENBAUM (CONFIDENTIAL)
` Q. Did you speak with anyone other
`than the lawyers that you've identified in
`the course of putting together your
`declarations about, about your work?
` A. I did not.
` Q. Okay. Did you ever ask the
`lawyers to speak with Dr. Hellmann, for
`example?
` A. I did not.
` Q. Did you ever speak with any of
`the other experts who submitted
`declarations in these cases yourself?
` A. I did not.
` Q. Okay. Did you speak with any of
`your colleagues about your work in this
`case?
` A. I did not.
` Q. Okay. So if we can turn now to
`your background. Can you just describe
`for me briefly what you were doing in 1997
`in terms of your career?
` A. I had spent, prior to that I had
`become boarded in hematology-oncology
`after being boarded in internal medicine,
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`spending four years at the University of
`Pennsylvania in my fellowship. Then nine
`years at the National Institutes of Health
`seeing patients but also doing preclinical
`work.
` And when I arrived at Wilshire
`Oncology in late 1996, I began immediately
`seeing patients clinically. I worked for
`that corporation. I saw full days of
`patients. 70 percent of those patients
`were patients with breast cancer. They
`were group active.
` Actually the leader of that
`group subsequently became the president of
`ASCO. He was very involved in doing
`clinical trials through the UCLA clinical
`trial network.
` We engaged with him immediately
`on my coming out to attempt to accrue
`patients to their studies. And I did that
`for seven years.
` Q. You mentioned preclinical work.
`Can you briefly describe for me your
`experience with doing preclinical work?
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` SUSAN TANNENBAUM (CONFIDENTIAL)
` A. Yeah. I cultured human
`umbilical vein and endothelial cells.
` Just some doughnuts to the labor
`and delivery floors got me the umbilical
`veins -- cords. I cultured them, put them
`in petri dishes. I was looking
`specifically at thrombosis and issues
`related to that, some of it utilizing
`patient's sera to see the effect on the
`production of different thrombotic factors
`in those cells.
` Q. Any other kind of preclinical
`work that you yourself conducted beyond
`that?
` A. No. I did that for the four
`years of my fellowship and then for the
`seven years -- the nine years that I was
`at the NIH, the same sort of work.
` We also participated and did
`some clinical trials with the
`investigators. They were clinical, not
`preclinical trials with investigators at
`the NIH in a variety of different tumor
`types.
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` Q. Okay. When you say you did that
`same sort of work for the nine years that
`you were at the NIH, just referring to
`preclinical work, what kind of preclinical
`work did you do at the NIH?
` A. Same sort of work. I had a
`laboratory. I was looking at umbilical
`vein and endothelial cells and things
`related to thrombosis.
` Q. And you were culturing those
`cells?
` A. I was.
` Q. And what kind of studies did you
`do with the cultured cells?
` A. Mostly looking at their
`production of clotting factors, Von
`Willebrand Factor, VWF factor, different
`factors that the cells produce in response
`to different forms of injury and stress.
` Q. Have you ever personally
`conducted a xenograft study?
` A. I have not.
` Q. Okay. Have you participated in
`any way in a xenograft study?
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` MR. DANFORD: Objection to form.
` A. I have not.
` Q. Okay. Would you consider
`yourself an expert in xenograft studies?
` A. I would not.
` Q. So turning to your experience
`with clinical trials, can you briefly give
`me an overview of your experience with
`clinical trials?
` A. Sure. It started in my
`fellowship. We were part of the Eastern
`Cooperative Oncology Group, called ECOG.
`Patients we saw in clinic we always looked
`for eligibility in those trials, variety
`of different patient types, breast, colon,
`lung. Excuse me.
` And, and then at the NIH I
`participated with people in their trials,
`seeing their patients but not as an
`investigator.
` And then at Wilshire Oncology
`participated in the UCLA network trials,
`so all the trials that UCLA had open in
`their network which included the phase 3
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`study of Herceptin plus chemotherapy.
` When I then moved to University
`of Connecticut, I was the principle
`investigator on many studies, including
`through ECOG and what's called the NSABP,
`which is the National Surgical Adjuvant
`Breast Project and we had many adjuvant
`and metastatic trials at our institution
`through them, also some industry-sponsored
`trials in both the metastatic and the
`neoadjuvant and adjuvant settings.
` Q. Prior to your work at UConn as a
`principle investigator, did you have the
`role of principle investigator in any of
`the earlier clinical trials that you were
`involved in?
` A. I did not.
` Q. Okay. So in the ECOG clinical
`trials that you worked on, what was your
`role in those trials?
` A. As a fellow or later on?
` Q. Let's start with fellow.
` A. Just a co-investigator accruing
`patients, making sure they're eligible for
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`the studies, making sure they follow
`through appropriately. But again, not a
`principle investigator at that time.
` Later, with the NSABP and ECOG
`as well as industry-sponsored trials,
`finding trials that seemed appropriate for
`our patient population, making sure we had
`numbers that would work, accruing the
`patients, making sure the trials were run
`according to guidelines.
` Q. In your work at ECOG, or with
`ECOG, did you participate in the design of
`any of those trials?
` A. I did not.
` Q. Okay. So then turning next to
`your involvement with clinical trials in
`NIH, what was your involvement with those
`clinical trials?
` A. I was just in general, aside
`from a few investigator-initiated studies,
`I generally saw the patients in
`consultations for toxicities related to
`trials that they were on. Virtually every
`patient in NIH is on a clinical trial.
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`That's kind of why they -- how they manage
`being there.
` So different trials I had
`different involvements, but basically,
`primarily, as a consultant helping them
`understand toxicities.
` Q. Okay. And for the clinical
`trials that you were involved in with the
`NIH, I take it you were not involved in
`the design of any of those trials; is that
`correct?
` A. Just some of the investigator-
`initiated studies, and again those weren't
`-- those were preclinical primarily.
` Q. Preclinical?
` A. Taking samples from patients but
`use them in preclinical models.
` Q. Can you describe -- and you did
`that work personally?
` A. I did it with a surgeon in the
`surgical branch of the NIH, and I couldn't
`go through the description of that. I
`really don't remember clearly at the time
`what we were doing.
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` Q. Okay. So did you design those
`preclinical experiments yourself?
` A. I helped him design them.
` Q. Okay. And you don't recall what
`the subject matter of those experiments
`were?
` A. I really don't.
` Q. Okay. And turning next then to
`-- and turning next to your work for UCLA
`or with UCLA, did you -- did you -- were
`you -- strike that.
` Were you involved in the design
`of any of those clinical trials?
` A. I was not.
` Q. What was your role in those
`trials?
` A. So, they were an exceptional
`program. I was grateful to be a part of
`it. We had retreats with them. They
`showed us the basic science that they were
`doing related to the design of the trials,
`the reason the trials were being done, and
`we just understood clearly by those
`interactions the importance of the trials
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