` _______________
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
` _______________
`
`Page 1
`
` PHIGENIX, INC.
` Petitioner
` v.
` IMMUNOGEN, INC.
` Patent Owner
` _______________
` Case No. IPR2014-00676
` Patent 8,337,856 B2
` _______________
`
` Volume 1
` DEPOSITION OF MICHAEL G. ROSENBLUM, Ph.D.
` Washington, D.C.
` Tuesday, December 16, 2014
`
`Reported by: John L. Harmonson, RPR
`Job No. 88355
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`IMMUNOGEN 2039, pg. 1
`Phigenix v. Immunogen
`IPR2014-00676
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`Page 2
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` December 16, 2014
` 9:31 a.m.
`
` Deposition of MICHAEL G. ROSENBLUM, Ph.D.,
`held at the offices of Andrews Kurth, 1350 I
`Street, Northwest, Washington, D.C., pursuant to
`Notice, before John L. Harmonson, a Registered
`Professional Reporter and Notary Public of the
`District of Columbia, who officiated in
`administering the oath to the witness.
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`Phigenix v. Immunogen
`IPR2014-00676
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` A P P E A R A N C E S
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`Page 3
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`On Behalf of Petitioner:
` ANDREWS KURTH
` 600 Travis Street
` Houston, TX 77002
` BY: GREG PORTER
`
` ANDREWS KURTH
` 1350 I Street Northwest
` Washington, DC 20005
` BY: PING WANG
`
`On Behalf of Patent Owner:
` STERNE KESSLER GOLDSTEIN & FOX
` 1100 New York Avenue
` Washington, DC 20005
` BY: ELDORA ELLISON
` ERIC STEFFE
`
`ALSO PRESENT:
` JOSEPH J. KENNY, ESQ., ImmunoGen, Inc.
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` M. ROSENBLUM
`--------------------------------------------------
` P R O C E E D I N G S
` 9:31 a.m.
`--------------------------------------------------
` Whereupon,
` MICHAEL G. ROSENBLUM, Ph.D.,
` after having been first duly sworn or affirmed,
` was examined and did testify under oath as
` follows:
` EXAMINATION
` BY MS. ELLISON:
` Q. Good morning, Dr. Rosenblum.
` A. Good morning.
` Q. For the record, would you state your
` full name?
` A. Michael Gordon Rosenblum.
` Q. Thank you. And the city in which you
` live?
` A. Houston -- or Sugar Land, Texas.
` Q. Have you been deposed before?
` A. I have.
` Q. How many times?
` A. Twice.
` Q. In which cases?
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` A. I was deposed in a case, in a patent
`case, about six years ago. And I was deposed in
`a criminal trial a year ago.
` Q. Would I be correct in assuming that
`you were not the defendant in that criminal
`trial?
` A. I was not the defendant.
` Q. Let's just for sake of clarity go over
`a couple of ground rules for today. So I will
`try not to talk over you, and in return I ask
`that you try not to talk over me. Okay?
` A. Perfect.
` Q. And you understand you're under oath
`today, correct?
` A. I do.
` Q. And you understand that means you have
`to tell the truth?
` A. Yes.
` Q. And one of the other ground rules is
`you need to answer out loud, please. Is that
`okay?
` A. I understand.
` Q. And you agree to do that, right?
` A. Yes.
`
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` Q. And if you have any questions about my
`questions, if anything is unclear, please ask me
`rather than counsel for Phigenix for
`clarification. Okay?
` A. I understand.
` Q. And do you agree to do that?
` A. Yes.
` Q. And if you don't ask for
`clarification, is it fair to assume that you
`understood my question?
` A. Yes.
` Q. And you understand that you're here to
`answer my questions today, correct?
` A. Yes.
` Q. The rules of the Patent Office require
`that you not discuss the substance of your
`testimony with counsel for Phigenix during any
`breaks during this cross-examination. Do you
`understand that?
` A. I understand.
` Q. And do you agree to abide by that?
` A. Yes, I do.
` Q. Thank you.
` Is there any reason why you would not
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` M. ROSENBLUM
`be able to testify truthfully today?
` A. No.
` Q. Are you under any medications or have
`any other conditions that might affect your
`ability to testify truthfully today?
` A. No.
` Q. In the previous cases where you were
`deposed, you mentioned a patent case about six
`years ago. For that case, did you serve as an
`expert witness?
` A. I believe so.
` Q. Who were the parties in that case?
` A. The Clayton Foundation for Research,
`and I cannot remember the company on the other
`side. I cannot remember their name.
` Q. What was the nature of that case, just
`generally speaking?
` A. It was regarding a patent of mine.
` Q. Do you remember which patent?
` A. It was a patent regarding a construct
`with the cytokine BLyS, B-L-y-S.
` Q. Was it a patent infringement case?
` A. I don't believe it was an infringement
`case.
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` Q. What was the nature of the dispute in
`that case?
` A. I believe that that was an inter
`partes review.
` Q. I can assure you that if it was six
`years ago it was not an inter partes review.
` A. They were challenging the validity of
`my patent. That's all I know.
` Q. What was the role of Clayton
`Foundation for Research in that lawsuit?
` A. They were the patent owner.
` Q. So Clayton owned your patent; is that
`correct?
` A. Yes.
` Q. And what was the purpose of the BLyS
`construct you mentioned? That's B-L-y-S,
`correct?
` A. Yes.
` Q. What was the purpose of the BLyS
`construct that you mentioned?
` A. I'm unclear as to what your question
`is.
` Q. What was the function of the BLyS
`construct that you mentioned?
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` A. The function of the BLyS construct was
`to target malignant B cells.
` Q. So was that BLyS construct an
`anticancer drug?
` A. Yes.
` Q. What was the outcome of that lawsuit?
` A. I believe they prevailed over our
`patent. I believe they invalidated our patent.
` Q. Do you have an understanding of the
`grounds on which your patent was invalidated?
` A. No, I do not.
` Q. I'll hand you a copy of your CV. This
`is exhibit --
` A. I have it.
` Q. You have your CV?
` A. Uh-huh.
` Q. I see that you brought several
`documents into the room with you today. Is that
`correct?
` A. I did.
` Q. What did you bring?
` A. I brought my declaration. I brought
`the decision of the inter partes review. And I
`brought my CV.
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` Q. May I see those, please?
` A. Yes, you may.
` Q. Why did you bring these with you?
` A. I thought you might question me about
`them.
` Q. Are there any markings on any of
`these?
` A. There are.
` Q. It looks like there is a marking on
`the cover page of your declaration. What does
`that say?
` A. Marking says "Priority date March 16,
`2000."
` Q. Is that your handwriting?
` A. That is.
` Q. Are there any other handwritten notes
`on your declaration?
` A. I have an underline on this page.
` Q. What page is that?
` A. That is page 8.
` Q. What did you underline? Did you
`underline that? Sorry. Let me ask you that
`first.
` A. Yes.
`
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` M. ROSENBLUM
` Q. What did you underline? Could you
`please read into the record what you underlined
`on page 8 of your declaration?
` A. Yes. I underlined Paragraph 12, the
`phrase starting "different drugs link or
`technologies and targeting antibodies.
`Antibodies targeting c-erbB2 (p185, HER2/neu,
`HER2) proto-oncogene were also well described at
`that time."
` Q. May I see that, please?
` A. Uh-huh.
` Q. Are there any handwritten notes in
`your copy of your declaration you brought into
`the room today? Is there an additional
`underlining on that page 8, Dr. Rosenblum?
` A. Yes. On page 8, eight lines from the
`bottom, underline the word "designated TA1."
` Q. And why did you underline "designated
`TA1"?
` A. It helps me to remember certain
`things.
` Q. Such as?
` A. The word "TA1."
` Q. Anything else?
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` A. No.
` Q. Do you have difficulty remembering the
`word "TA1"?
` A. No.
` Q. Do you know what TA1 is?
` A. Yes.
` Q. What is it?
` A. TA1 is the designation for an
`antibody.
` Q. Which antibody?
` A. TA1.
` Q. And what are the characteristics of
`TA1?
` A. TA1 is an antibody that binds to HER2.
` Q. What's HER2?
` A. HER2 is a protein found on the surface
`of certain cells.
` Q. Which cells?
` A. HER2 is found on many kinds of cells.
` Q. Which ones?
` A. HER2 is found on cardiac cells. HER2
`is found on a number of cancer cells. HER2 has
`been found on salivary gland cells and a variety
`of other cells too numerous to mention.
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` Q. Name as many as you can, please.
` A. I think I just did.
` Q. So you cannot identify any additional
`cells on which HER2 is found; is that correct?
` A. I think at this time my memory extends
`to the cells and cell types that I just
`mentioned.
` Q. So you say that HER2 is found on many
`cells. Correct? Would you agree with me that
`HER2 is found on many cells? Strike that
`question.
` Can you name any additional cell types
`on which HER2 is found?
` A. Not at present.
` Q. You mentioned that HER2 is found on a
`number of cancer cells. On what types of cancer
`cells is HER2 found?
` MS. ELLISON: Can we mark the time?
` THE WITNESS: The protein HER2 is
` found on a number of cancer cells. Many
` breast cancer cell lines and tumors express
` HER2. It's well known in the literature
` that, I believe, colon and lung are also
` HER2 expressers, but there are many other
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` cell types that HER2 is known to be
` expressed on.
`BY MS. ELLISON:
` Q. Can you name any additional ones?
` A. Not at present.
` Q. Is HER2 expressed on normal lung
`cells? By "normal," I mean noncancerous.
` MS. ELLISON: Let's mark the time
` again and see how long it takes the witness
` to answer the question.
` THE WITNESS: I believe HER2 is
` expressed on many normal cells. I am not
` certain whether HER2 is expressed at any
` level on normal lung cells.
`BY MS. ELLISON:
` Q. What's the basis for your belief that
`HER2 is expressed on many normal cells?
` A. There have been extensive publications
`in the literature which describes the normal
`expression of HER2 -- the expression of HER2 on
`normal cells.
` Q. Can you identify any of those
`publications?
` A. Are you asking if I have memorized the
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`chapter and verse for each of those publications?
` Q. No, that was not my question. My
`question was: Can you identify any of those
`publications?
` A. How would that identification be made?
` Q. Can you identify in any kind of way,
`such as the author's name, the journal, title?
`Any identifying information.
` A. I have not memorized the literature on
`HER2.
` Q. Can you identify even a single
`publication?
` A. Given time, I believe that I can find
`a number of publications that you're asking for.
` Q. As you sit here today, can you
`identify even a single publication of the type
`we've been discussing?
` A. As I sit here today, as I mentioned, I
`have not committed to memory the literature on
`HER2.
` Q. Are you aware of any researchers who
`have studied the expression of HER2 on normal
`cells?
` A. Your question is unclear. Could you
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`restate it, please?
` Q. Do you know of any researchers who
`have studied the expression of HER2 on normal
`cells?
` A. Again, you're asking me if I know the
`names of researchers? Do I know them personally?
`I'm --
` Q. Do you know the names?
` A. -- unclear as --
` Q. I'm sorry. I didn't mean to interrupt
`you.
` Do you know the names?
` A. We talked about that, right?
` Q. We did. And if you would like to
`continue your answer, you go right ahead.
` A. Well, let me start again. I know that
`there are a number of researchers in the field
`who have published their findings, and that is
`accessible to one of ordinary skill in the art,
`to the world's database that examined HER2
`expression.
` Q. Can you name any of those researchers?
` A. As we sit here today, no.
` Q. Is HER2 expressed on epithelial cells?
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`And if you don't know, you can say you don't
`know.
` A. I have not recently evaluated the
`expression of HER2 and the publications regarding
`specific cell types and specifically endothelial
`cells.
` Q. My question was about epithelial
`cells.
` A. I'm sorry, epithelial cells.
` Q. So as you sit here today, you cannot
`tell me one way or the other as to whether HER2
`is expressed on epithelial cells, correct?
` A. As we sit here today, my answer was
`that I have not reviewed the literature in that
`regard.
` Q. My question is not whether you
`reviewed the literature. My question is whether
`you know if HER2 is expressed on epithelial
`cells. Do you know?
` A. That knowledge would have been gained
`by a review of the literature, and as I said
`previously, I have not recently reviewed the
`literature on HER2 expression on various cell
`types.
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` Q. When was the last time you reviewed
`the literature on HER2 expression in various cell
`types? I'm sorry, strike that question.
` Have you ever reviewed the literature
`on HER2 expression in various cell types?
` A. I have.
` Q. And when was the last time you
`reviewed the literature on HER2 expression in
`various cell types?
` A. I believe my most recent review of the
`literature on HER2 expression in different cell
`types was several years ago.
` Q. When you say "several years ago,"
`roughly what year was that?
` A. At least four years ago.
` Q. Is HER2 expressed on urinary tract
`cells?
` A. Again, as I mentioned previously, I
`have not reviewed the literature regarding the
`expression of HER2 on various cell types, so I
`cannot say for certain.
` Q. Do you know whether HER2 is expressed
`on reproductive cells? Let me rephrase that.
` Do you know whether HER2 is expressed
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`on cells of the reproductive tract?
` A. Can you be more specific? Your
`question is a little too broad.
` Q. What's too broad for you about that
`question?
` A. There are many cells in the
`reproductive tract.
` Q. Okay. Do you know whether HER2 is
`expressed on any cells in the reproductive tract?
` A. I believe, as I've mentioned
`previously, I have not reviewed the literature on
`HER2 expression in different cell types. So as
`we sit here today, I do not know the answer to
`your question.
` Q. Do you know whether HER2 is expressed
`on cells of the respiratory tract?
` A. Would you kindly rephrase your
`question? There are many cells in the
`respiratory tract.
` Q. Do you know whether HER2 is expressed
`on any cells of the respiratory tract?
` A. As I mentioned in my previous
`response, it has been many years since I have
`reviewed the literature on expression of HER2 in
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`various cell types. So as we sit here today, I
`cannot answer your question.
` Q. Do you know whether HER2 is expressed
`on liver cells?
` A. Again, as we sit here today, it has
`been several years since I reviewed the
`literature on HER2 expression in different cell
`types. So as we sit here today, I cannot -- I do
`not have the information to be able to answer
`your question. I don't have that information at
`my fingertips.
` Q. In formulating the opinions set forth
`in your declaration, did you consider whether
`HER2 is expressed on cells of the urinary tract?
` A. Your question is too unfocused to
`effectively answer. Can you be more specific,
`please?
` Q. What's unclear to you about my
`question?
` A. Which opinion are you discussing --
` Q. Any opinion --
` A. -- in my declaration?
` Q. Any opinion in your declaration.
` You still have a copy of your
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`declaration in front of you, correct?
` A. I do.
` MS. ELLISON: We can give you copies
` if you like.
` MR. PORTER: I've got a copy.
` MS. ELLISON: I can get it. We'll
` hand you copies of the declaration, and
` we'll give one to the witness just for
` completeness sake as well, his declaration,
` which is Exhibit 1016.
` (Exhibit 1016 marked for
` identification and attached hereto.)
`BY MS. ELLISON:
` Q. Dr. Rosenblum, I'm going to hand you
`back the decision on institution.
` A. Thank you.
` Q. So you have in front of you a copy of
`your declaration, Exhibit 1016.
` Dr. Rosenblum, I'm going to strike my
`question. I'm going to ask you a different
`question that might make everyone's day go a
`little more smoothly.
` In formulating the opinions set forth
`in your declaration, did you consider whether
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`HER2 is expressed on any cell types?
` A. The opinions in my declaration that
`were expressed related to the composition of the
`immunoconjugate described in the issued patent.
` Q. Is that your whole answer?
` A. Yes.
` Q. Okay. So that's not an answer to my
`question, and your job today is to answer my
`questions.
` My question was: In formulating the
`opinions set forth in your declaration, did you
`consider whether HER2 is expressed on any cell
`type?
` MR. PORTER: Objection to form.
`BY MS. ELLISON:
` Q. You still need to answer the question
`even though your counsel objected, unless he
`instructs you not to answer.
` A. Yes.
` Q. Which cell types?
` A. In formulating my opinion, I focused
`on the cell types for which the conjugates were
`known to be biologically active in terms of the
`data that was presented.
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` Q. To which data are you referring?
` A. The data in question refers to the
`different cell types that you had asked about.
` Q. So the data that were presented.
`Presented where?
` A. The data that I reviewed was presented
`not only in the patent under review but in papers
`cited in the patent and in the Chari papers
`already disclosed and cited.
` And in my review of the state of the
`art at the time of the priority date, I reviewed
`all of the literature regarding these types of
`immunoconjugates.
` Q. You stated that in formulating your
`opinion you focused on B cell types for which the
`conjugates were known to be biologically active
`in terms of the data that were presented. Which
`cell types are you referring to?
` A. I think that to answer your question I
`would have to go through all of the publications
`that I reviewed and list every cell type that
`you're requesting. And I would be happy to do
`that.
` Q. You have your declaration in front of
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`you, right?
` A. I do.
` Q. Let's turn to Paragraph 8 of your
`declaration. Your declaration states: "In
`particular, I have reviewed the following
`documents," colon, and then it lists a number of
`exhibits. Correct?
` A. Correct.
` Q. In preparing your declaration, did you
`review any other documents?
` A. Yes.
` Q. Which ones?
` A. The charge to me was to review the
`state of the art in the literature as of the
`priority date of this application. So I reviewed
`many other documents.
` Q. Did you rely on any of those in
`forming your opinions?
` A. Yes.
` Q. Which ones?
` A. I reviewed many other documents,
`numerous other documents that are in the
`literature from the priority date of 2000 and
`previously.
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` Q. Outside of the documents listed in
`Paragraph 8 of your declaration, on what
`documents did you rely in formulating your
`opinions?
` A. My opinion of the literature at the
`time was based on numerous other documents that
`are not listed here. The documents that are
`listed here form the basis for my opinion of the
`specific patent under review.
` Q. In forming the opinions set forth in
`your declaration, did you rely on documents that
`are not listed in Paragraph 8 of your
`declaration?
` A. Could you restate the question?
` Q. What's unclear about my question?
` A. I would just like to hear you say it
`again, please.
` MS. ELLISON: The court reporter will
` read it back.
` (Whereupon, the requested portion was
` read back by the Reporter.)
`BY MS. ELLISON:
` Q. I'll rephrase that question.
` In forming the opinions set forth in
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`your declaration, did you rely on documents that
`are not listed in Paragraph 8 of your
`declaration?
` A. I did.
` Q. Which documents?
` A. As I stated, my review of the
`literature on antibody drug conjugates and the
`state of the art at the time leading up to the
`priority date formed the basis for understanding
`the context in which this publication -- or this
`patent priority date occurred. So my job was to
`understand the state of the art at the time. And
`in doing so, I reviewed a number of other
`manuscripts, numerous other manuscripts, on
`antibody drug conjugates and antibodies and
`humanized antibodies.
` Q. When you say "numerous other
`manuscripts," do you mean numerous manuscripts
`not listed here in Paragraph 8?
` A. Numerous other manuscripts not listed
`in Paragraph 8, correct.
` Q. Which ones?
` A. I do not have that list available at
`present.
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` Q. Can you identify even a single
`additional document that you relied on that's not
`listed in Paragraph 8?
` A. As we sit here today, I cannot.
` MS. ELLISON: Counsel, do you have
` such a list?
` MR. PORTER: We can take a break and
` we can see. We've got a stack of other
` papers and things, if you want to look at
` those.
` MS. ELLISON: We might come back to
` that. Thank you.
` MR. PORTER: Is this a good time for a
` break?
` MS. ELLISON: If you want a break, we
` can take one. Would you like a break?
` THE WITNESS: Yes, that would be fine.
` MS. ELLISON: Let's go off the record.
` (Recess taken.)
` MS. ELLISON: So we're back on the
` record.
`BY MS. ELLISON:
` Q. Dr. Rosenblum, in preparing your
`declaration, did you review any documents other
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`than those listed in Paragraph 8 of your
`declaration?
` A. I did.
` Q. Okay. Which documents?
` A. As I pointed out, the review of the
`literature as of March of 2000, I needed to go
`back and reconstruct my memory as to the state of
`the art as of 2000, 14 years ago. And so I
`reviewed much of the literature on antibodies,
`antibody drug conjugates, Herceptin, and what the
`state of the art of the literature was at that
`time, in addition to the specific articles
`related to this particular patent and issue at
`this particular point.
` The listed articles starting on page 5
`in my declaration are the primary documents that
`form the basis -- much of the basis for my
`opinion in this document.
` Q. Are there any other documents that
`form the basis for your opinion in your
`declaration?
` A. Yes. Again, as I mentioned,
`recreating the state of the art at the time, I
`had to read many other documents, and those are
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`not listed here but those were part of my
`background review of the state of the art of the
`literature at the time.
` Q. Which documents were they? I'm asking
`you to identify any that you can identify. So
`which additional documents?
` A. Again, I don't have a list of those
`documents, but I believe that we may be able to
`make a list of those documents available.
` Q. Can you identify any of them as you
`sit here right now?
` A. As we sit here right now, I cannot
`identify by name or designation those documents.
`My goal is to give you correct information, and
`doing so from memory, I might give you incorrect
`information. And I don't want to do that.
` Q. Did you choose the list of documents
`that's set forth in Paragraph 8 of your
`declaration?
` A. Could you restate your question,
`please? Rephrase.
` Q. You mentioned that you considered a
`number of documents. Correct?
` A. Yes.
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` Q. And some of those documents are listed
`here in Paragraph 8, correct?
` A. Yes.
` Q. And some of the documents you
`considered are not listed in Paragraph 8,
`correct?
` A. The documents listed in Paragraph 8
`form the primary review and opinion of the
`specific issue relating to this particular
`patent.
` Q. Some of the documents you considered
`are not listed in Paragraph 8, correct?
` A. Yes.
` Q. Did you decide which documents to list
`in Paragraph 8?
` A. Yes.
` Q. On what basis did you choose the
`documents that are listed in Paragraph 8 as
`opposed to the documents you considered but did
`not list in Paragraph 8?
` A. These documents appear to be the most
`relevant documents with respect to this
`particular issue.
` Q. You say "this particular issue."
`
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`Which issue is that?
` A. That would be this particular patent
`and the relevance of literature which might
`impinge on antibody drug conjugates, HER2
`antibodies, that is specific for this
`declaration.
` Q. When did Phigenix retain you to serve
`as an expert in this case?
` A. I don't have the exact date in front
`of me, but I believe it was approximately seven
`months ago.
` Q. What's seven months ago?
` MS. WANG: That would be May?
` THE WITNESS: I don't have the exact
` date. I'm sorry.
`BY MS. ELLISON:
` Q. But it was approximately seven months
`ago?
` A. Again, I don't have the exact date. I
`apologize.
` Q. Was it approximately seven months ago?
` A. It seems to be.
` Q. That's May, approximately.
` In carrying out your work for
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`Phigenix, did you conduct any searches of the
`literature? Let me strike that.
` In carrying out your work on behalf o