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`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`Inter Partes Review Case No. IPR2016-01370
`Patent Number 8,664,231
`
` KOIOS PHARMACEUTICALS LLC,
`Petitioner,
`
`-vs-
` MEDAC GESELLSCHAFT FÜR KLINISCHE
` SPEZIALPRAPARATE MBH,
`Patent Owner.
`
`Deposition of TERRI SHOEMAKER
`August 30, 2017
`Chicago, Illinois
`
`Reported by:
`SUSAN K. TODAY
`Job no: 19488
`
`TransPerfect Legal Solutions
`212-400-8845 - Depo@TransPerfect.com
`
`Page 1 of 19
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`KOIOS Exhibit 1040
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`

`

`Page 2
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`Page 4
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` I N D E X
`EXAMINATION
` TERRI SHOEMAKER
` BY MR. NOROOZI..................... 5
`
`E X H I B I T S
`NO EXHIBITS MARKED.
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` The deposition of TERRI SHOEMAKER, taken
` in the above-entitled cause, before SUSAN K. TODAY,
` a Notary Public within and for the County of
` DuPage, State of Illinois, and a Certified
` Shorthand Reporter of said state, C.S.R. No.
`84-2212, at Suite 3200, 191 North Wacker Drive,
` Chicago, Illinois, on August 30, 2017, commencing
` at 1:56 p.m.
`
`Page 3
`
` PRESENT:
` NOROOZI, PC,
` (1299 Ocean Avenue, Suite 450,
` Santa Monica, California 90401,
`310-975-7074), by:
` MR. KAYVAN B. NOROOZI, ESQ.
` kayvan@noroozipc.com,
` appeared on behalf of the Petitioner;
`
` HALEY GUILIANO LLP,
` (75 Broad Street, Suite 1000,
` New York, New York 10004,
`646-973-2500), by:
`MR. JAMES F. HALEY, JR., ESQ.
`james.haley@hglaw.com,
` appeared on behalf of the Patent Owner.
`
` REPORTED BY: SUSAN K. TODAY, C.S.R., R.P.R.
` License No. 84-2212.
`
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`Page 5
`(WHEREUPON, the witness was duly
`sworn.)
`TERRI SHOEMAKER,
` called as a witness herein, having been first duly
` sworn, was examined and testified as follows:
`EXAMINATION
` BY MR. NOROOZI:
`Q. Good afternoon, Ms. Shoemaker.
`A. Hello.
`Q. How did you prepare for today?
`MR. HALEY: Just generally.
` BY THE WITNESS:
`A.
`I just -- I had a few conversations with
` my attorney.
` BY MR. NOROOZI:
`Q. About how long?
`A. An hour.
`Q.
`Just one time today before the
` deposition?
`A. Today and a little bit yesterday.
`Q. Did you review any documents?
`A. We did not.
`Q. You understand that in this proceeding
` during breaks you're not permitted to discuss your
`2 (Pages 2 to 5)
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`KOIOS Exhibit 1040
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`

`

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`Page 8
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` testimony with your counsel?
`A.
`I am.
`Q. By "I am" you mean you understand that?
`A.
`I understand that, yes.
`Q. You submitted a declaration in this
` proceeding, true?
`A. That's correct.
`Q. All right. Have you reviewed your
` declaration recently?
`A.
`I did review it, yes.
`Q. When was that?
`A. Yesterday.
`Q. Did you review any other documents in
` preparation for today?
`A.
`I did not.
`Q. Did you review the other exhibits cited
` in your declaration?
`A. There were two exhibits in my
` declaration, yes.
`Q. You reviewed those?
`A.
`I reviewed them, yes.
`Q. Did you review anything else?
`A. No. That was it.
`MR. NOROOZI: Counsel, that one is for you.
`Page 7
`
` BY MR. NOROOZI:
`Q. And, Ms. Shoemaker, here is your
` declaration that has been marked as Exhibit 2011 in
` this proceeding.
`A. Okay.
`Q. Now, in your declaration you don't state
` that you or anyone else at Medac ever discussed the
` state-of-the-art that's relevant to the '231
` patent's claims and the validity of those claims
` with Dr. Schiff; is that true?
` MR. HALEY: Objection to form.
` BY THE WITNESS:
`A. Can you repeat the question?
` BY MR. NOROOZI:
`Q. Sure. In your declaration you do not
` state that you or anyone else at Medac ever
` discussed information regarding the
` state-of-the-art relevant to the claims of the '231
` patent or the validity of those claims with
` Dr. Michael Schiff; is that right?
` MR. HALEY: Objection to form.
` BY MR. NOROOZI:
`Q.
`I'm sorry. Could you repeat your answer
` so it's clear.
`
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`It does not state that in this
`A.
` declaration.
`Q. And in fact, neither you nor anyone at
` Medac ever had such a conversation with Dr. Schiff,
` true?
` MR. HALEY: Objection; form.
` BY THE WITNESS:
`A.
`I don't recall.
` BY MR. NOROOZI:
`Q. You don't know that you did, right?
`A.
`I don't recall if I had that
` conversation.
`Q. Okay. Let me just ask you more broadly.
` Medac engaged Dr. Schiff one time for a one-day
` meeting, right?
`A. That is correct.
`Q. The purpose of that meeting was not to
` discuss issues regarding the validity or
` inventiveness or novelty of the claims of the '231
` patent in light of the prior art, correct?
` MR. HALEY: Objection; form.
` BY THE WITNESS:
`A. There were many objectives for that
` meeting.
`
`Page 9
`
` BY MR. NOROOZI:
`Q. The objective of discussing the novelty
` or validity or any prior art relevant to the claims
` of the '231 patent was not one of the objectives of
` the meeting, right?
` MR. HALEY: Objection; form.
` BY THE WITNESS:
`A.
`I don't recall if we discussed that
` during the meeting.
` BY MR. NOROOZI:
`Q. Well, you have an agenda that sets forth
` the objectives of the meeting, right?
`A. That is correct.
`Q. You've looked at that agenda, right?
`A. That is correct.
`Q. And the validity or novelty or
` inventiveness of the claims of the '231 patent or
` the prior art is not part of the items discussed in
` that agenda, right?
` MR. HALEY: Objection; form.
` BY THE WITNESS:
`A. Our product was discussed in that
` agenda.
`
`TransPerfect Legal Solutions
`212-400-8845 - Depo@TransPerfect.com
`
`3 (Pages 6 to 9)
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`Page 3 of 19
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`KOIOS Exhibit 1040
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`

`

`Page 10
`
` BY MR. NOROOZI:
`Q. So the issues that I just asked about
` were not discussed, right?
` MR. HALEY: Objection; form.
` BY THE WITNESS:
`A.
`I do not recall.
` BY MR. NOROOZI:
`Q. You don't recall what was listed in the
` document that set forth the objectives for the
` meeting?
`A. You asked me if I recall specifically
` what we discussed at the meeting and I said I do
` not recall specifically what we discussed at the
` meeting.
`Q. My question is, there is an agenda that
` you state in your declaration memorializes the
` objectives of the meeting, right?
`A. That is correct. And the objectives
` were to discuss the product.
`Q. Not the novelty or inventiveness of the
` '231 patent's claims, true?
`A. That is part of the product.
`Q. Part of the product is whether or not
` the '231 patent as a matter of law is novel or
`Page 11
`
` inventive?
`A.
`I do not recall specifically what we
` discussed at the meeting.
`Q. Okay.
`A.
`I can't answer that question.
`Q. So what I'm asking you is a different
` question. It's about what was stated in the
` document that sets forth the objectives for the
` meeting. Are you with me so far?
`A.
`I am.
`Q. All right. You have reviewed that
` document, right?
`A.
`I looked at it yesterday.
`Q. Okay. Now, you have an unredacted copy
` of the document, right?
`A.
`I looked at your -- at the exhibit which
` is a redacted copy.
`Q. Okay. Have you ever seen the unredacted
` copy?
`A. Well, I'm sure I saw it when we produced
` it. I can't tell you what it says. I have not
` looked at it. It's five years ago.
`Q. Okay. Well, but you have the document,
` right?
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`TransPerfect Legal Solutions
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`Page 12
`I looked at the redacted document
`A.
` yesterday.
`Q. Okay. But you have access to the
` unredacted copy if you want to see it, right?
`A.
`If I want to see it, I have it.
`Q. Okay. So here is Exhibit 2008.
`And, counsel, here's a copy for you.
`Can you confirm that Exhibit 2008 is the
` document that sets forth the objectives of the
` meeting that Dr. Schiff attended that we've been
` referring to?
`A. Yes.
`Q. As you sit here today, you are not able
` to state that you or anyone else at Medac ever
` discussed the novelty or inventiveness of the
` claims of the '231 patent with Dr. Schiff, true?
` MR. HALEY: Objection; form.
` BY THE WITNESS:
`A.
`I do not recall what we discussed at the
` 2012 meeting.
` BY MR. NOROOZI:
`Q. So you can't tell me that you discussed
` the novelty or inventiveness of the claims of the
` '231 patent with Dr. Schiff, right?
`
`Page 13
`
` MR. HALEY: Objection; form.
` BY THE WITNESS:
`A.
`I do not recall what we discussed at the
` 2012 meeting.
` BY MR. NOROOZI:
`Q. So I want to be clear about my question
` because I'm asking a very specific question and I
` think you're giving me a general answer that you
` don't recall at all. And the reason I keep going
` back to the question is I want to make sure whether
` we agree what you cannot state since you don't
` recall. Are you with me so far?
`A. You're asking me if I recall something
` that was discussed at the meeting, and my answer is
` I do not recall what was discussed at the meeting.
`Q. And in fact, I'm not asking you if you
` recall what was discussed at the meeting in
` particular. I'm asking whether you can state today
` under oath that a particular thing was discussed.
`A.
`I do not recall what we discussed at the
` meeting, therefore I cannot tell you what I did
` discuss or what I did not.
`Q. Okay. So you have a declaration that's
` before you as Exhibit 2011, right?
`4 (Pages 10 to 13)
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`Page 4 of 19
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`KOIOS Exhibit 1040
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`

`

`Page 14
`
`A. That is correct.
`Q. And in that declaration you state in
` Paragraph 6 that you or others at Medac gave
` Dr. Schiff confidential information, right?
`A. That is correct.
`Q. And just to be clear, the court reporter
` can't pick up nods of the head.
`A. Yes, that is correct.
`Q. Thank you. When you say confidential
` information in Paragraph 6 of your declaration, you
` have a capital C and a capital I, right?
`A. That is correct.
`Q. And so when you say confidential
` information with a capital C and a capital I in
` Paragraph 6 of your declaration, you're referring
` to the definition of confidential information that
` is set forth in Exhibit 2007 that's mentioned in
` your declaration, which is the agreement between
` Medac and Dr. Schiff, right?
`A. So ask me that one more time.
`Q. When you refer to confidential
` information with a capital C and a capital I in
` Paragraph 6 of your declaration, you're referring
` to confidential information as that term has been
`Page 15
` defined in the agreement between Medac and
` Dr. Schiff, true?
`A. Do you have the agreement between Medac
` and Dr. Schiff?
`Q.
`I do. It was cited in your declaration
` as Exhibit 2007. And I would direct your attention
` to Paragraph 4 on the second page.
`A. Okay.
`Q. So to repeat my question, in Paragraph 6
` of your declaration when you refer to confidential
` information with a capital C and a capital I, you
` are referring to confidential information as that
` term has been defined in the agreement between
` Medac and Dr. Schiff, right?
`A. That's correct.
`Q. Now, the definition of confidential
` information in the agreement between Medac and
` Dr. Schiff as set forth in Paragraph 4 of Exhibit
` 2007 is specific, right?
`A.
`I think it is very broad.
`Q. But it's specific, right?
`A. Specific to the company's trade secrets,
` know-how, intellectual property, proprietary
` information.
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`Page 16
`Q. You see that it also has some carve-outs
` in Romanettes 1 and 2?
`A. Okay.
`Q. When you submitted your declaration, you
` did not evaluate whether any particular information
` that was given to Dr. Schiff in fact fell within
` the bounds of the definition of confidential
` information in the agreement between Medac and
` Dr. Schiff, including the carve-outs or not, right?
` MR. HALEY: Objection; form.
` BY THE WITNESS:
`A. When I said confidential information in
` my declaration, I was referring to how we define
` confidential information in Section 4.1 of our
` consultant agreement, which includes 4.1 and
` Carve-Out 1 and 2.
` BY MR. NOROOZI:
`Q. And so what was -- withdrawn.
` Do you know what information it was that
` you or others gave to Dr. Schiff that was in your
` statement confidential information under the
` agreement?
`A.
`I don't recall specifically what we
` talked about at that advisory board.
`
`Page 17
`Q. How do you know it was confidential
` information within the meaning of the agreement
` then?
`A. Because we -- I know we shared
` confidential information at the advisory board, but
` it was five years ago and I cannot tell you today
` exactly what we talked about. I don't recall. We
` have had many advisory boards since then.
`Q. How do you know it was confidential if
` you don't know what it was?
`A. Well, I know we shared confidential
` information at advisory boards through the years as
` we structured them, but I cannot sit here today and
` give you specifics. It was five years ago and I
` don't remember.
`Q. So there's no particular piece of
` information that you can identify from the meeting
` that Dr. Schiff attended that we could evaluate
` under the definition of confidential information in
` Paragraph 4 of Exhibit 2007 to determine whether in
` fact the information was or was not confidential,
` right?
`A. Well, we shared a lot about our product
` which is confidential, but that's not what you
`5 (Pages 14 to 17)
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`KOIOS Exhibit 1040
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`Page 18
` asked me. You asked me specifically about the
` validity of the patent. Isn't that what you asked
` me?
`Q. That was a different question before.
` Right now I'm just asking about anything that was
` discussed at that meeting. Are you with me on
` that?
`A. Yes. So ask me your question again.
`Q. Since you do not recall what was
` discussed at the meeting with Dr. Schiff, are you
` able to tell me any particular piece of information
` that was provided to him that you believe falls
` within the definition of confidential
` information --
`A. Well, all of the information --
`THE COURT REPORTER: Wait, wait, wait. Let
` him finish.
` BY MR. NOROOZI:
`Q. We can only talk one at a time. You
` have to wait for me to finish --
`A. Okay. Go ahead.
`Q.
`-- because she can only write down one
` person at a time.
`A. Fair enough.
`
`Page 19
`
`Q. Withdrawn. I'll start the question
` over.
`
`I believe that you were about to tell me
` that everything about your product constitutes
` confidential information, right?
`A. Well, ask me the question.
`Q. All right. Since you don't recall any
` particular information that was given by you or
` others at Medac to Dr. Schiff at the meeting that
` he attended, are you able to tell me about any
` particular piece of information that we can
` evaluate under the definition of confidential
` information in the agreement to determine whether
` in fact such information when it was provided to
` Dr. Schiff was or was not confidential information?
`A. The advisory board was held in September
` 2012 and we had not shared any information about
` our product publicly. So the meeting was a
` confidential -- so all of the information we shared
` at the meeting was confidential.
`Q. And you understand that under the terms
` of Paragraph 4 and the Carve-Outs 1 and 2, even if
` information was confidential at the time that you
` shared it but it subsequently becomes public, it's
`
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`Page 20
` no longer within the definition of confidential
` information, right?
` MR. HALEY: Objection; form.
` BY THE WITNESS:
`A. Well, I can read what Sections 1 and 2
` say.
` BY MR. NOROOZI:
`Q. Well, do you share the understanding
` that I articulated or do you have a different view
` of what they mean?
`A. No. I agree. Your question was at the
` meeting what parts of the meeting were
` confidential, and my answer is the entire meeting
` and information was confidential.
`Q. And so my further question to you is, in
` light of what has become public since that meeting,
` is there any information that was given to
` Dr. Schiff that remains confidential information as
` of -- or remained confidential information as of
` the date that Dr. Schiff submitted his declaration
` in this proceeding?
`A.
`I will say I don't recall specifically
` all of the topics we discussed at the September
` 2012 meeting. Therefore, I cannot answer that
`Page 21
`
` question.
`Q. Okay. Taking a look at Exhibit 2008,
` which is the summary of the meeting objectives, you
` see at the top it refers to the meeting in question
` being the first Medac RA advisory council meeting?
`A. Yes.
`Q. Were you involved in putting that
` meeting together?
`A. Yes.
`Q. Were you involved in deciding who to
` invite?
`A. Yes.
`Q.
`Is it correct that the people you chose
` to invite and Medac chose to invite were people who
` were considered leaders in the rheumatology space?
`A. When we put the meeting together we knew
` very few people in the rheumatology space. We did
` not know if they were experts or not experts.
`Q. You considered them leaders at the time?
`A. We looked for people who had large
` dermatology practices and who were published. I
` don't know if they were leaders.
`Q. You see that at the top of the document
` it refers to rheumatology leaders?
`6 (Pages 18 to 21)
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`KOIOS Exhibit 1040
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`It does say rheumatology leaders.
`A.
`Q. So is it fair to say that at the time
` that Medac invited the individuals who ended up
` attending that meeting it considered those
` individuals to be rheumatology leaders?
`A. We did not know the individuals; we
` hadn't met them. We identified those individuals
` who had large rheumatology practices and who were
` published. We did not know if they were leaders or
` if they were not.
`Q. So when the document Exhibit 2008 refers
` to rheumatology leaders, in that document itself
` it's referring to the people who are listed --
`A. That's correct.
`Q.
`-- on Page 5, right?
`A. Correct.
`Q.
`Including Dr. Schiff, right?
`A. That is correct.
`Q. Now, as you sit here today, do you have
` any reason to believe that Dr. Schiff is not an
` expert in the field of rheumatology?
`A. Dr. Schiff hasn't practiced rheumatology
` in quite some time. He doesn't have a patient
` practice, which I did not know when he came to the
`Page 23
` meeting. I don't know if he's an expert or not.
`Q. What do you mean by "quite some time"?
`A. A few years.
`Q. How many years?
`A.
`I don't know.
`Q. So you certainly can't say that he's not
` an expert, right?
`A.
`I can't say that he is not an expert and
` I can't say that he is an expert.
`Q.
`It's true that Medac in its own filings
` in front of the Patent Trial and Appeal Board in
` other contexts has referred to Dr. Schiff as at
` least one of ordinary skill in the art, true?
`A.
`I don't know.
`Q. You are familiar with the invention of
` the '231 patent?
`A.
`I am familiar.
`Q. You understand that the first claim,
` Claim 1, claims methotrexate, among other things,
` in a concentration from 30 milligrams per
` milliliter to 100 milligrams per milliliter?
`A.
`I do understand that's what it says.
`Q.
`If methotrexate is offered -- is
` administered to a patient in the manner described
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` in Claim 1 with the exception that the
` concentration is 29 milligrams per milliliter, will
` the treatment be operable? Will it function?
` MR. HALEY: One second.
` Objection; form.
` BY THE WITNESS:
`A.
`I don't know.
` BY MR. NOROOZI:
`Q. You can't say that when the border is
` crossed from less than 30 milligrams per milliliter
` concentration to at least 30 milligrams per
` milliliter concentration somehow an injection of
` subcutaneous methotrexate for the treatment of
` autoimmune diseases suddenly works differently than
` it would at 29 milligrams per milliliter?
` MR. HALEY: Objection; form, outside the scope
` of Ms. Shoemaker's declaration in this case.
` BY MR. NOROOZI:
`Q. You still have to answer my question.
`A.
`I'm not an expert. I can't answer that
` question.
`Q. You are the CEO of the U.S. subsidiary
` of Medac, right?
`A. That is correct.
`
`Page 25
`
`Q. And you are involved in all kinds of
` issues related to the company's business, right?
`A. That is correct.
`Q. And the issue of the '231 patent and its
` validity as well as the benefits of its invention
` comes within the scope of your responsibilities,
` right?
` MR. HALEY: Objection; form, outside the
` scope.
` BY THE WITNESS:
`A. Repeat your question.
` BY MR. NOROOZI:
`Q.
`Issues related to the validity of the
` '231 patent as well as the benefits of the
` invention claimed by the '231 patent fall within
` the scope of your responsibilities, true?
` MR. HALEY: Objection; form, outside the scope
` of Ms. Shoemaker's declaration.
` MR. NOROOZI: Could you just limit your
` objections to form, please?
` MR. HALEY: No, because you're going outside
` the scope of a declaration. You're not entitled to
` do that under the rules. You're wasting our time;
` you're asking questions that you're not entitled to
`7 (Pages 22 to 25)
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`
` ask. So move on.
` MR. NOROOZI: I am entitled to ask them. And
` if you want to take it up with the board, I'll
` explain why. She's the CEO of the company and she
` submitted -- her experts have submitted
` declarations and ultimately she has knowledge of
` the company's business. And so I'm entitled to
` probe the veracity of things that the experts have
` said.
` MR. HALEY: No. You're entitled to probe the
` veracity of her declaration. You're doing cross
` examination of her declaration. That's all you're
` entitled to.
` MR. NOROOZI: Well, you can take that up with
` the PTAB; and if they agree with you, then they'll
` ignore what we're doing. And if they disagree,
` then I'll get to use my testimony and that's the
` end of that conversation.
` So let's go back to my question. Could
` you repeat it, please?
`(WHEREUPON, the record was read by
`the reporter as requested.)
` MR. HALEY: Same objections; outside the scope
` of her declaration.
`
`Page 27
`
` BY THE WITNESS:
`A. So what are the issues related?
` BY MR. NOROOZI:
`Q.
`I don't know. I'm not the CEO. You
` are, right?
`A.
`I am the CEO.
`Q. So issues related, it was phrased
` broadly to include --
`A.
`I'm just asking you to be a bit more
` specific.
`Q.
`I would like to have an answer to my
` question as I phrased it.
`A.
`I'm asking you to be more specific so I
` can answer your question.
`Q. Well, if there are any issues related to
` the validity of the '231 patent or the benefits of
` the invention claimed by the '231 patent that fall
` within the scope of your responsibilities, then the
` answer to my question would be yes. And if there
` are no such issues, then the answer to my question
` would be no.
` So with that in mind, could you please
` answer my question?
`A.
`I'm asking you to define the issues.
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`Page 28
`Q. But you don't get to do that. I get to
` ask a question and you have to answer it. That's
` how it works.
`A. Well, I get to ask you to clarify your
` question.
`Q. Only if you don't understand it. Do you
` not understand my question?
`A.
`I don't understand what issues. I'm
` asking you to clarify what issues.
`Q. Okay. So for instance, what's an issue
` that may not fall within your responsibility that
` fits the rest of my question?
`A.
`I don't know. I'm asking you to define.
`Q.
`It doesn't work that way. I'm sorry.
` The way it works is that if you understand my
` question, then I'm entitled to an answer to the
` full --
`A. Okay. Then I'm not --
`Q. Don't interrupt me, please. There can
` only be one person speaking at a time.
`A. Okay. I apologize. Go right ahead.
`Q.
`If I ask a question and you understand
` the question, I'm entitled to an answer that covers
` the full scope of my question. Do you understand
`Page 29
`
` that?
`I do understand that.
`A.
`Q. Okay. So I have a question pending I
` would like the answer to.
`A. And I'm not understanding what -- I'm
` asking you to explain to me what you are defining
` as issues related to the validity. And if you can
` explain that to me, I will tell you if it's in my
` scope. I do not understand what you're asking me.
`Q. Okay. So do you get to see the
` statements and arguments that are made by Medac's
` lawyers and its experts in this proceeding before
` they're filed?
`A.
`I do.
`Q. You're not aware of any -- withdrawn.
`Do you also have access to what Medac
` knows about the benefits and importance of the
` claimed concentration range of the '231 patent,
` that being from 30 milligrams per milliliter to 100
` milligrams per millimeter?
`A. The IP belongs to Medac GMBH, not Medac
` Pharma. So I don't have access to all of the
` information.
`Q.
`If there are studies or publications
`8 (Pages 26 to 29)
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`Page 30
` related to the benefits of the claimed invention of
` the '231 patent which studies or publications are
` known to Medac, would they be known to you?
` MR. HALEY: Objection; form, outside the scope
` of her declaration.
` BY THE WITNESS:
`A. Potentially. I'm not aware of all of
` the studies.
` BY MR. NOROOZI:
`Q. To your knowledge, are you aware of any
` study or publication that shows that there is
` something so significant about the starting point
` of 30 milligrams per milliliter concentration and
` the ending point of 100 milligrams per milliliter
` concentration such that an injection of
` subcutaneous methotrexate for the treatment of
` inflammatory autoimmune diseases would not operate
` outside of those concentration ranges?
` MR. HALEY: Objection; form, outside the scope
` of her declaration. This is not a discovery
` deposition.
` MR. NOROOZI: I'm sorry.
` MR. HALEY: This is cross examination of her
` declaration.
`
`Page 31
` MR. NOROOZI: If you continue to interrupt my
` deposition and you continue to try to hint or guide
` the witness with objections that go beyond
` objection; form, then I would like it noted for the
` record that you are violating the PTAB's rules and
` I will seek all of the available remedies for you
` interrupting the deposition.
` If you have an objection, please make it
` as objection; form. And if you would like to
` pursue exclusion of any testimony, please go ahead
` and do that.
` Under the rules of evidence and
` procedure that apply at the PTAB I'm entitled to
` ask her about issues that are relevant to the
` positions that Medac has taken in this proceeding
` that include her declaration as well as what other
` experts have submitted.
` MR. HALEY: You're not entitled to do that.
` You're entitled to cross examine her on her
` declaration. Look at the rules. Her testimony is
` uncompelled testimony. It's based on a
` declaration. The cross examination rules say
` you're entitled to cross-examine her on her
` declaration. Nothing else, full stop.
`
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`Page 32
` So I will continue to make my objections
` because you are way, way, way beyond the rules.
` This is not a discovery deposition. You're not
` here to find out what she thinks about all sorts of
` topics. She didn't put those topics in her
` declaration. Her declaration confines or cabins
` her testimony.
` BY MR. NOROOZI:
`Q. So let's talk about your declaration for
` a minute, Ms. Shoemaker. Are you with me so far?
`A.
`I am.
`Q.
`In your declaration you do not express
` any opinion or any view or any statement about the
` criticality or importance of a methotrexate
` concentration within the range of 30 milligrams per
` milliliter to 100 milligrams per milliliter, true?
`A.
`In this declaration I do not make a
` statement about that, that is correct.
`Q.
`If you wanted to, you could have, right?
`A.
`It is not in this declaration.
`Q.
`If you wanted to say something about
` that, you could have, right?
`A.
`It is not in this declaration.
`Q. Are you avoiding my question?
`
`Page 33
`A. No. I'm answering your question. There
` is nothing in this declaration. It wasn't the
` topic of the declaration.
`Q.
`If you wanted to include in your
` declaration statements about the importance of
` methotrexate in a concentration of 30 milligrams
` per milliliter to 100 or exactly 50, or 40 to 80,
` you could have done that, right?
`A. Yes.
`Q. You understand that in this proceeding
` Medac has put together an expert who discusses the
` barriers to entry or lack thereof for bringing a
` product such as Rasuvo to market?
`A.
`I don't know what you're talking about.
`Q. You certainly have knowledge about how
` much time it took for you and others at Medac to
` prepare the Rasuvo product, develop the product, go
` through the FDA approval process, and get the
` product approved and bring it to market, right?
`A. That's correct.
`Q.
`In your declaration you don't talk about
` any of those issues, right?
`A. Not in this declaration.
`Q. You also have knowledge about the cost
`9 (Pages 30 to 33)
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`Page 34
` that was entailed to do everything necessary to
` take the Rasuvo product from idea as set forth in
` the '231 patent to a commercial product on the
` market, right?
`A. That is correct.
`Q. You don't talk about that in your
` declaration, right?
`A. Not in this declaration.
`Q. And you're aware that as you sit here
` today you and Medac as a company spend money on
` marketing to promote the sale of the Rasuvo
` product, right?
` MR. HALEY: Objection; form, outside the scope
` of her declaration.
` BY THE WITNESS:
`A. Yes.
` BY MR. NOROOZI:
`Q. You don't talk about that in your
` declaration, right?
`A. Not in this declaration.
`Q. Would you say that the time, risk, and
` cost involved in taking the Rasuvo product from
` what's described in the '231 patent to a
` commercially viable product was trivial?
`
`Page 35
` MR. HALEY: Objection; form, outside the scope
` of her declaration.
` BY THE WITNESS:
`A. No.
` BY MR. NOROOZI:
`Q. At the time that you were planning to
` develop the Rasuvo product and bring it to market
` did you consider it a low-risk undertaking?
` MR. HALEY: Objection; form, outside the scope
` of her declaration. Move on, counsel.
` MR. NOROOZI: I have a question pending.
` BY THE WITNESS:
`A. No.
` BY MR. NOROOZI:
`Q. Are you aware of litigation in the
` United Kingdom with respect to the validity of the
`U.K. counterpart to the '231 patent?
` MR. HALEY: Objection; form, outside the scope
` of her declaration.
` BY THE WITNESS:
`A. Not in any detail.
` BY MR. NOROOZI:
`Q. Are you aware that a court in the United
` Kingdom found the U.K. equivalent to the '231
`
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`
`I am aware. I'm not aware of the
`
` patent invalid?
` MR. HALEY: Objection; form, outside the scope
` of her declaration.
` BY THE WITNESS:
`A. Not in any detail.
` BY MR. NOROOZI:
`Q. Well, are you aware or are you not aware
` of that?
`A.
` details.
`Q. How about The Hague; are you aware that
` The Hague found a counterpart to the '231 patent
` invalid?
` MR. HALEY: Objection; outside the scope and
` form.
` BY THE WITNESS:
`A. No.
` BY MR. NOROOZI:
`Q. Never heard about that?
`A. No.
`MR