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` UNITED STATES PATENT AND TRADEMARK OFFICE
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`____________________________
` )
`CELLTRION, INC., )
` )
` Petitioner, )
` )
`vs. ) Case No. IPR2017-01121
` )
`GENENTECH, INC., ) Patent No. 7,846,441
` )
` Patent Owner. )
` )
`____________________________)
`
` VIDEOTAPED DEPOSITION OF
` SUSAN DESMOND-HELLMANN, M.D.
` Concord, California
` Friday, March 23, 2018
`
`Reported by:
`CATHERINE A. RYAN, RMR, CRR
`CSR No. 8239
`
`212-279-9424
`
`Veritext Legal Solutions
`www.veritext.com
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`212-490-3430
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`Page 2
` UNITED STATES PATENT AND TRADEMARK OFFICE
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`____________________________
` )
`CELLTRION, INC., )
` )
` Petitioner, )
` )
`vs. ) Case No. IPR2017-01121
` )
`GENENTECH, INC., ) Patent No. 7,846,4411
` )
` Patent Owner. )
` )
`____________________________)
`
` Videotaped deposition of
`SUSAN DESMOND-HELLMANN, M.D., taken on behalf of
`Petitioner, at Regus, 1320 Willow Pass Road,
`Suite 600, Concord, California, beginning at
`8:59 a.m. and ending at 1:14 p.m., on Friday,
`March 23, 2018, before CATHERINE A. RYAN, Certified
`Shorthand Reporter No. 8239.
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`Page 3
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`APPEARANCES:
`For Petitioner Pfizer:
` KIRKLAND & ELLIS, LLP
` BY: AMANDA HOLLIS
` Attorney at Law
` 300 North LaSalle
` Chicago, Illinois 60654
` (312) 862-2200
` (312) 862-2011 Fax
` amanda.hollis@kirkland.com
` BY: KAREN L. YOUNKINS
` Attorney at Law
` 333 South Hope Street
` Los Angeles, California 90071
` (213) 680-8140
` (213) 680-8500 Fax
` karen.younkins@kirkland.com
`
`For Petitioner Celltrion:
` GOODWIN PROCTER LLP
` BY: ROBERT V. CERWINSKI
` Attorney at Law
` The New York Times Building
` 620 Eighth Avenue
` New York, New York 10018
` (212) 459-7240
` (212) 412-9078 Fax
` rcerwinski@goodwinlaw.com
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`APPEARANCES (Continued):
`
`For Patent Owner Genentech, Inc.:
` DURIE TANGRI
` BY: DARALYN J. DURIE
` Attorney at Law
` 217 Leidesdorff Street
` San Francisco, California 94111
` (415) 362-6666
` (415) 236-6300 Fax
` ddurie@durietangri.com
`
` WILMER CUTLER PICKERING HALE and DORR LLP
` BY: ANDREW J. DANFORD
` 60 State Street
` Boston, Massachusetts 02109
` (617) 526-6806
` (617) 526-5000 Fax
` andrew.danford@wilmerhale.com
`
`Also Present:
`SEAN GRANT, Videographer, Veritext
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`Page 5
`
` INDEX
`WITNESS EXAMINATION
`SUSAN DESMOND-HELLMANN, M.D.
` BY MS. HOLLIS 8
` BY MS. DURIE 149
`
` EXHIBITS
`NUMBER DESCRIPTION PAGES
`Exhibit 1 "United States Patent, Hellmann, 9
` Patent No.: US 7,846,441 B1, Date of
` Patent: Dec. 7, 2010"; 27 pages
`
`Exhibit 2 "United States Patent, Paton et al., 9
` Patent No.: US 7,892,549 B2, Date of
` Patent: *Feb. 22, 2011"; 24 pages
`
`Exhibit 3 "DECLARATION UNDER 37 CFR SECTION 11
` 1.131, HOSPIRA EX. 1011 Vol. 2, Page
` 119 - Page 147"; 29 pages
`
`Exhibit 4 "DECLARATION UNDER 37 CFR SECTION 101
` 1.131, HOSPIRA EX. 1011 Vol. 2, Page
` 237 - 312"; 76 pages
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`Page 6
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` EXHIBITS (Continued)
`NUMBER DESCRIPTION PAGES
`Exhibit 5 DECLARATION OF DR. SUSAN 109
` DESMOND-HELLMANN"; 25 pages
`
`Exhibit 6 "A Supplement to ONCOLOGY, March 1997, 139
` VOL 11, NO 3 (SUPPLEMENT NO2), HOSPIRA
` EX. 1006, Page 1 - Page 12"; 12 pages
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`SUSAN DESMOND-HELLMANN
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`Page 7
` Concord, California; Friday, March 23, 2018
` 8:59 a.m.
`
` THE VIDEOGRAPHER: Good morning. We're on
`the record. The time is 8:59 a.m., and the date is
`March 23rd, 2018.
` This begins the videotaped deposition of
`Dr. Susan Desmond-Hellmann, M.D., taken on behalf of
`counsel for Petitioner in the matter of Celltrion,
`Inc. versus Genentech, Inc., filed in the U.S.
`Trademark Office Before the Patent Trial and Appeal
`Board, Case No. IPR2017-01121.
` This deposition is being held at Regus in
`Concord, California.
` My name is Sean Grant, the videographer
`from Veritext, and the court reporter is
`Catherine Ryan, also from Veritext.
` Please note that audio and video recording
`will take place unless all parties have agreed to go
`off the record. Microphones are sensitive and may
`pick up whispers, private conversations, or cell
`interference.
` At this time, will counsel please identify
`themselves and state whom they represent.
` MS. HOLLIS: This is Amanda Hollis from
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`the law firm of Kirkland & Ellis. With me is
`Karen Younkins, also from Kirkland and Ellis. We
`represent the petitioner, Pfizer.
` MR. CERWINSKI: Robert Cerwinski, Goodwin
`Procter LLP, on behalf of the petitioner, Celltrion.
` MS. DURIE: Daralyn Durie from Durie
`Tangri, representing Genentech and the Witness.
` MR. DANFORD: Andrew Danford from Wilmer
`Hale, representing Genentech and the Witness.
` THE VIDEOGRAPHER: Thank you.
` Will the certified court reporter please
`swear in the witness.
` SUSAN DESMOND-HELLMANN, M.D.,
`having been administered an oath, was examined and
`testified as follows:
` EXAMINATION
`BY MS. HOLLIS:
` Q Good morning, Dr. Desmond-Hellmann.
` A Good morning.
` Q Do you understand that this deposition is
`being conducted in connection with proceedings
`before the United States Patent and Trademark
`Office?
` A I do.
` Q And do you understand that these
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`proceedings involve two patents on which you are
`named as an inventor?
` A I do.
` (Exhibit 1 and Exhibit 2 were marked for
` identification by the court reporter.)
` MS. HOLLIS: I'm going to hand you two
`exhibits that have been premarked.
` You've been handed Exhibit 1.
` MS. DURIE: Do you have a copy of the '549
`as well?
` MS. HOLLIS: Yes.
` MS. DURIE: Thank you.
`BY MS. HOLLIS:
` Q Exhibit 1 -- is that United States Patent
`7,846,441?
` A It is.
` Q And you're listed as the sole inventor,
`correct?
` A Correct.
` Q Exhibit 2 -- is that United States Patent
`No. 7,892,549?
` A It is.
` Q And you are named as one of the inventors,
`correct?
` A That's correct.
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` Q Okay. Will you understand it if I refer
`to Exhibits 1 and 2 as the "'441" and "'549"
`patents, respectively, today?
` A Yes.
` Q Thank you.
` You have submitted multiple declarations
`to the United States Patent and Trademark Office
`relating to the '441 patent, correct?
` A That's correct.
` Q Were you asked to submit those
`declarations?
` A I worked with the -- the legal folks at
`Genentech when they would contact me to submit those
`declarations.
` Q Did they ask you to submit those
`declarations?
` A Yes.
` Q Okay. And which legal team asked you to
`submit those dec- -- declarations?
` A I'm trying to think. Some of them were a
`while ago. The -- my memory of those declarations
`is that someone from the Genentech intellectual
`property group -- the legal team that does
`intellectual property group would be in touch with
`me.
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` Q A lawyer in-house at Genentech, so to
`speak?
` A Well, I have two lawyers here with me
`today who are not in-house lawyers of Genentech. So
`the -- I can't tell you that there was always an
`in-house lawyer, and sometimes the legal team would
`get in touch with my administrative assistant to --
`to do some of the logistics. So I actually don't
`always know who it is that was originally asking.
` Q Okay. But a Genentech representative
`asked you to submit the declarations?
` A In every case where I gave a declaration,
`I linked that to someone from Genentech. Genentech
`legal themselves or their agent would be asking me.
` Q Thank you.
` (Exhibit 3 was marked for identification
` by the court reporter.)
` THE VIDEOGRAPHER: 3.
` THE WITNESS: So can I just -- am I
`supposed to put these in there? Okay.
`BY MS. HOLLIS:
` Q You've been handed another exhibit, what's
`been marked as Exhibit 3 to your deposition. This
`should bear the label "HOSPIRA EXHIBIT 1001 [sic],
`Volume 2, Page 119" on the front; is that correct?
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` A That is correct.
` Q Is this one of the declarations that you
`submitted to the United States Patent and Trademark
`Office in connection with the '441 patent?
` A It is.
` Q And is that your signature on page 2 of
`this exhibit?
` A That is my signature.
` Q Above your signature is a statement. I
`won't read it, but it refers, generally, to a belief
`that the statements are true, and knowledge that a
`willful statement and the like so made are
`punishable by fine or imprisonment, et cetera.
` By signing the document on page 2, are you
`affirming your understanding of that statement?
` A That's correct.
` Q At the time you signed this, what was your
`understanding of the purpose of the declaration?
` MS. DURIE: And I would simply caution you
`not to reveal the content of communications with
`counsel.
` THE WITNESS: Can you ask the question
`again?
`BY MS. HOLLIS:
` Q Sure.
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` At the time you signed this declaration,
`what did you understand its purpose to be?
` A I understood its purpose to be an
`attestation that -- that the facts that were
`outlined above my signature were correct and that
`this would be, I think, going to the Patent Office.
` Q Did you understand that your application
`for the '441 patent had been rejected at that point
`by the Patent and Trademark Office?
` A I'm trying to remember the details back in
`2000. I know there was -- I guess my understanding
`was that we had been asked for more information
`and -- and more clarity to defend the patent.
`That -- that's my memory of the discussion I had
`with Genentech's counsel.
` MS. DURIE: And, again, I would caution
`you not to disclose the --
` THE WITNESS: Okay.
` MS. DURIE: -- substance of those
`communications.
` THE WITNESS: Okay.
`BY MS. HOLLIS:
` Q Are you saying you have no memory of the
`application being rejected prior to you submitting
`this declaration?
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` A Yeah, I have -- I do have a memory of --
`of -- I'm just trying to remember the details of
`that. Yeah, I have a vague memory of -- of what
`you're saying, that the -- the application was
`rejected, but I don't remember the details of that.
` Q And did you understand that the Patent and
`Trademark Office had determined that your patent
`application claimed treatment methods that were
`already disclosed by published literature?
` A That I don't remember.
` Q Do you remember that your patent
`application was rejected over something called the
`Baselga 1997 reference?
` A I -- I know now, in reviewing the
`documents, that that was the case.
` Q Okay. And do you understand that your
`declaration that we're looking at right now,
`Exhibit 3, was submitted after that rejection had
`happened?
` A Yes.
` Q And it was submitted for the purpose of
`overcoming that rejection, right?
` A That's correct.
` Q Okay. To your understanding, was your
`declaration submitted to try to prove that you had
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`invented the claimed invention before Baselga 1997
`was published?
` A Yes.
` Q I'd like to ask you about the
`circumstances of how this document was created.
` Who wrote the first draft of Exhibit 3?
` A The slides or the declaration?
` Q The declaration.
` A I can't tell you who wrote the first
`draft.
` Q Was it you?
` A My memory of this is I reacted to
`something that was written and given to me by
`counsel.
` Q The lawyers wrote it, to your
`understanding?
` MS. DURIE: Objection. Calls for
`speculation.
` THE WITNESS: Yeah, I'm -- I'm not sure.
`All I know is that I received the document, read the
`document and the slides and attested to its
`accuracy, but I can't tell you who wrote the first
`draft.
`BY MS. HOLLIS:
` Q Did you make any edits to the document?
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` A I don't remember.
` Q You don't remember making any edits?
` A I don't remember if I did or I didn't.
` Q Are there any words -- this is a two-page
`declaration.
` Are there any words here that are your
`original words?
` A I -- I would actually -- it would be hard
`for me to tell you that. I -- I would use these
`words. I mean, these -- these -- these sound a lot
`like words I would use, but whether or not they are
`my original words -- you know, when -- if you look
`at any of these details, they were things that I
`would have said, but did I say them originally? I
`can't tell you that. These -- these were words that
`many people at Genentech who were working on -- on
`Herceptin in combination with paclitaxel would have
`used, including me.
` Q Is it possible that the declaration was
`written and all you did was sign it?
` A That's not possible.
` Q But you have no memory of actually writing
`the declaration?
` A In 2000? I don't remember if I -- if I --
`it -- it is not possible for me to remember the
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`Page 17
`details of what happened in 2000. What I can tell
`you is I signed it, and I would review it and make
`sure that it was accurate. That I am very confident
`in.
` Q Okay. So, ultimately, you did review and
`approve all of the statements that are contained in
`this Exhibit 3, right?
` A That's correct.
` Q Okay. And do you believe, confidently,
`that all the statements in this Exhibit 3 are true?
` A I do believe that confidently.
` Q Are there any errors or statements in your
`declaration that you wish to change?
` A No.
` Q How much time did you spend on this
`declaration before signing it?
` A I don't remember how much time I spent on
`it.
` Q Can you give me any estimate at all?
` A No.
` Q Okay. In preparing the declaration marked
`as Exhibit 3, did you talk to anyone besides
`lawyers?
` A I don't believe I did.
` Q Did you review any files or documents,
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`SUSAN DESMOND-HELLMANN
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`Page 18
`other than what was ultimately attached to the
`declaration, in preparing your declaration marked as
`Exhibit 3?
` A I don't remember reviewing anything except
`for the attached documents.
` Q Who gave you the attached documents to --
`to review?
` A I don't remember.
` Q Would that have been the lawyers?
` A That would have -- yes, that would be my
`memory of that, that the lawyers would give me the
`attached documents.
` Q And how were those documents found, to
`your knowledge? Do you know?
` A Well, the attached documents are a -- a
`PDC presentation, and the -- the PDC presentations
`were kept on file at Genentech. The -- my memory is
`I had a pretty big set of files that included all
`the PDC documents of -- of presentations, and that
`was where the lawyers would get these files, because
`this was a very important product development
`meeting, and we kept the minutes and the
`presentations.
` Q To your understanding, were the exhibits
`that are attached to Exhibit 3 documents from
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`Page 19
`
`Genentech's files relating to PDC meeting?
` A That's my memory, yes.
` Q Okay. And would it have been the lawyers
`who selected those documents out of the files?
` A The lawyers or the lawyers together
`with -- with staff of Genentech or with me or my
`administrative assistant who knew where the files
`were.
` Q Well, you don't remember, yourself,
`looking at any documents in preparing your
`declaration. You testified to that already, right?
` A Well, I looked at the attached documents.
` Q Right. Just the attached --
` A Yes.
` Q -- ones, right?
` A Yeah.
` Q I'm talking about the -- the process of
`selecting these documents for your declaration.
` Who would have chosen these documents to
`attach to your declaration? Would that have been
`the Genentech lawyers?
` A Yeah, I'm trying to make sure that I
`understand your question, because the -- the -- my
`memory of this is discussing it with the lawyers.
` So what it sounds like you're -- and I'm
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`SUSAN DESMOND-HELLMANN
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`Page 20
`trying to be careful not to talk about what I talked
`to lawyers about, given the instructions I've been
`given, but the -- the -- my memory is -- so this is
`a presentation I gave at the PDC. So the -- the
`discussions I had with the lawyers that led to me
`signing this and this being attached included me
`talking about what happened at the time with the
`lawyers and them selecting this document.
` So this was -- this document wasn't
`selected without me having a discussion, but I
`wasn't standing in front of the files going and
`thumbing through them. Do you see what I'm saying?
`But it -- the -- the -- I was involved in the
`dialogue that led to the attachment of this PDC
`presentation, because this is a PDC presentation
`that I gave.
` Q The declaration says that you declare that
`you're the inventor of the '441 patent, right?
` A That's correct.
` Q Okay. And did you direct people to look
`for documents to show that you were the inventor of
`that patent?
` MS. DURIE: I'm going to, again, just -- I
`object on privilege grounds.
` Subject to the caution I gave you before,
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`SUSAN DESMOND-HELLMANN
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`Page 21
`you can answer the question without disclosing the
`content of privileged communications.
` THE WITNESS: As a part of assembling this
`and attesting to this, I discussed with the legal
`team what had happened that -- during the time when
`I presented this and what the circumstances were.
`BY MS. HOLLIS:
` Q Did you look for -- well, what exactly did
`you -- are you saying that you did say something
`that prompted the search of documents?
` A What I'm saying is that I had discussions
`with the legal team about the actions that I took
`and what I believed should be done at Genentech to
`study Herceptin and amend the protocol that led to
`the combination of Herceptin -- Herceptin and
`paclitaxel. How that happened, what was in my head,
`and what I presented at the PDC was a discussion I
`had with Genentech's legal team, and so this
`presentation that's attached to this attestation was
`a part of that process. And so that was how I was
`involved, because I had a very strong memory of what
`had happened and the presentation that I gave that's
`attached here that led to the invention.
` Q In the first paragraph of your
`declaration, you say that you're the sole inventor
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`SUSAN DESMOND-HELLMANN
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`Page 22
`
`of the claims of your patent, correct?
` A That is correct.
` Q At the time you signed this, did you have
`an understanding of what was required to be a sole
`inventor of patent claims?
` A I'm not a lawyer, but to the degree to
`which it's practical for me as a physician and a
`scientist, yes, I -- I believe I understood that.
` Q What did you understand at the time was
`required to be a sole inventor of patent claims?
` A That it was my idea and that it was novel.
` Q Anything else?
` A I think those were the main things that
`were on my mind.
` Q When you stated in your declaration that
`you believed you were the sole inventor, did you
`intend to suggest that you fulfilled those
`requirements?
` A Yes.
` Q Has your understanding of "sole inventor"
`changed since you signed this declaration marked as
`Exhibit 3?
` A No.
` Q When you signed -- excuse me.
` On paragraph 12 -- in paragraph 12, you
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`SUSAN DESMOND-HELLMANN
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`Page 23
`
`say that you conceived of a method.
` Do you see that?
` MS. DURIE: Objection. Foundation. There
`isn't a paragraph 12.
` MS. HOLLIS: I'm sorry.
` THE WITNESS: There's --
` MS. HOLLIS: -- paragraph 2.
` THE WITNESS: So the one that's labeled
`number "2"?
`BY MS. HOLLIS:
` Q Paragraph 2 of Exhibit 3 -- are you on
`that paragraph?
` A Yes.
` Q Okay. And in paragraph 2, you say that
`you conceived of a method.
` Do you see that?
` A I do see that.
` Q And when you signed this, did you
`understand that the method in paragraph 2 was the
`method that Genentech was trying to patent?
` A I did understand that.
` Q Okay. And at the time you signed this,
`did you have an understanding of what was required
`to conceive of an invention?
` A I felt like I did understand that, yes.
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`SUSAN DESMOND-HELLMANN
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`Page 24
` Q What did you understand was required to
`conceive of an invention?
` A That it was my idea.
` Q Anything else?
` A Not really.
` Q And when you stated in your declaration
`that you had conceived of the claim method, did you
`intend to suggest that you believed you fulfilled
`that requirement?
` A Yes.
` MS. DURIE: Objection. Yeah.
`BY MS. HOLLIS:
` Q Okay. Now, Genentech wanted the Patent
`and Trademark Office to grant the patent for which
`you were submitting your declaration, right?
` A Yes.
` Q Can you explain why Genentech was
`interested in getting that patent?
` MS. DURIE: Again, I would just caution
`you not to disclose the substance of communications
`with counsel. If you have an independent basis for
`answering the question, you may do so.
` THE WITNESS: Yeah, I -- I think that
`would be -- I -- I wouldn't have unique knowledge
`outside of the discussions I had with counsel at the
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`SUSAN DESMOND-HELLMANN
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`Page 25
`
`time.
`BY MS. HOLLIS:
` Q Do you have a general understanding of why
`Genentech was interested in getting patents from
`your experience there?
` A Yes.
` Q Can you explain why Genentech was
`interested in getting patents as a general matter?
` A As a general matter, like any innovator,
`it's to protect their exclusivity in the market.
` Q By "exclusivity in the market," what are
`you talking about?
` A That the -- the patent allows them to be
`the sole seller of Herceptin.
` Q To exclude others from selling it,
`correct?
` A Correct.
` Q Okay. And, in that sense, Genentech had
`an incentive to show that -- the Patent and
`Trademark Office that you had possessed the claimed
`invention before that Baselga reference we talked
`about, right?
` A Yes.
` Q Okay. And you did, too, right, because
`you were an executive of the company?
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`SUSAN DESMOND-HELLMANN
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`Page 26
` MS. DURIE: Objection fou- -- objection.
`Form.
` You can answer.
` THE WITNESS: Yeah, I -- it -- for me,
`when I was reviewing this, the most important thing
`was: Did everything that was outlined here and the
`timing, given that I was signing this as the
`inventor -- that it was true. That was the most
`important thing when I reviewed the documents, to
`make sure that everything lined up, because this was
`done in 2000, and these matters happened in 1996,
`and so my memory of this, and in looking at this
`document right now, is I wanted to make sure that
`what I was signing was true.
`BY MS. HOLLIS:
` Q You also had an incentive, though, to get
`a patent for Genentech, didn't you?
` MS. DURIE: Objection. Form.
` THE WITNESS: At the time I signed this
`document, I worked for Genentech, and so I have no
`argument with what you're saying.
` MS. HOLLIS: Okay.
` Q You gave the Patent and Trademark Office
`three documents to show that you had conceived of
`the invention, right?
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`Page 27
` A I believe there were three different
`documents, yeah.
` Q And those documents are attached as
`Exhibit A, B, and C to your declaration, correct?
` A Let me just take a look.
` That is correct.
` Q Would it make sense to you if I refer to
`those documents today as the "conception" documents,
`as a shorthand?
` A That's okay with me.
` Q Okay. Now, do the conception documents
`show a plan to administer a combination of Herceptin
`and paclitaxel to people having HER2 positive breast
`cancer?
` A The -- the conception document, as you --
`as you pull them, the -- the one labeled "A" was my
`presentation that I gave to the PDC, and it -- it
`demonstrates -- it -- it outlines a proposal that I
`made to -- to revise the clinical protocol, and the
`proposal calls for changing the protocol -- amending
`the protocol so that paclitaxel was an option for
`patients, and it -- and in this document, I made a
`recommendation, and I outlined the pros and cons of
`that recommendation, because I was asking for
`approval of management, and labeled "B" and "C" are
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`SUSAN DESMOND-HELLMANN
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`Page 28
`the minutes that articulate the -- the -- the
`decision-making body called the "PDC," the Product
`Development Committee, who I was requesting
`permission to make this amendment to the protocol.
` Q Okay. So my question asked whether these
`conception documents show a plan to administer the
`Herceptin and paclitaxel combination to people
`having HER2 breast cancer. You did not answer
`"Yes," but you described it as a proposal, and
`you -- you added stuff.
` A Yeah.
` Q Would it be correct to say that these
`conception documents show a proposal to administer a
`combination of Herceptin and paclitaxel to people
`having that type of breast cancer?
` A Well --
` MS. DURIE: Objection. Form.
` Go ahead.
` THE WITNESS: -- if you want me to use
`your words, "the plan" -- so -- so I had a plan. I
`was pretty excited about the plan, which is why I
`remember it so well, because I was really fired u