1
`
` UNITED STATES PATENT AND TRADEMARK OFFICE
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
` + + + + +
`____________________________
` :
`IN THE MATTER OF: :
` :
`FLATWING PHARMACEUTICALS, :
`LLC AND MYLAN : Case Nos.
`PHARMACEUTICALS, INC., : IPR2018-00168,
` Petitioners, : 2018-00169,
` : 2018-00170,
` v. : 2018-00171
` :
`ANACOR PHARMACEUTICALS, : U.S. Patent Nos.
`INC., : 9,549,938,
` : 9,566,289,
` : 9,566,290,
` Patent Owner. : 9,572,823
` :
`____________________________:
` Friday,
` November 9, 2018
` Washington, D.C.
`
`DEPOSITION OF:
` PAUL REIDER
`called for examination by Counsel for the
`Petitioner FlatWing Pharmaceuticals, pursuant to
`Notice of Deposition, in the law offices of
`Williams & Connolly LLP, located at 725 12th
`Street NW, when were present on behalf of the
`respective parties:
`
`(202) 234-4433
`
`Neal R. Gross and Co., Inc.
`Washington DC
`
`www.nealrgross.com
`FlatWing Ex. 1045, p. 1
`
`
`
` UNITED STATES PATENT AND TRADEMARK OFFICE
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
` + + + + +
`____________________________
` :
`IN THE MATTER OF: :
` :
`FLATWING PHARMACEUTICALS, :
`LLC AND MYLAN : Case Nos.
`PHARMACEUTICALS, INC., : IPR2018-00168,
` Petitioners, : 2018-00169,
` : 2018-00170,
` v. : 2018-00171
` :
`ANACOR PHARMACEUTICALS, : U.S. Patent Nos.
`INC., : 9,549,938,
` : 9,566,289,
` : 9,566,290,
` Patent Owner. : 9,572,823
` :
`____________________________:
` Friday,
` November 9, 2018
` Washington, D.C.
`
`DEPOSITION OF:
` PAUL REIDER
`called for examination by Counsel for the
`Petitioner FlatWing Pharmaceuticals, pursuant to
`Notice of Deposition, in the law offices of
`Williams & Connolly LLP, located at 725 12th
`Street NW, when were present on behalf of the
`respective parties:
`
`(202) 234-4433
`
`Neal R. Gross and Co., Inc.
`Washington DC
`
`www.nealrgross.com
`FlatWing Ex. 1045, p. 1
`
`
`
`2
`
`APPEARANCES:
`
`On Behalf of Petitioner FlatWing
`Pharmaceuticals, LLC:
`PHILIP D. SEGREST, JR., ESQ.
`Husch Blackwell LLP
`120 South Riverside Plaza
`Suite 2200
`Chicago, Illinois 60606
`312-526-1548
`philip.segrest@huschblackwell.com
`On Behalf of Petitioner Mylan Pharmaceuticals,
`Inc.:
`JAD A. MILLS, ESQ.
`Wilson Sonsini Goodrich & Rosati
`Suite 5100
`701 Fifth Avenue
`Seattle, Washington 98104
`206-883-2554
`jmills@wsgr.com
`
`On Behalf of the Patent Owner Anacor
`Pharmaceuticals, Inc.:
`AARON P. MAURER, ESQ.
`ANTHONY H. SHEH, ESQ.
`Williams & Connolly LLP
`725 12th Street NW
`Washington, D.C. 20005
`202-434-5282 (Maurer)
`202-434-5436 (Sheh)
`amaurer@wc.com
`asheh@wc.com
`
`(202) 234-4433
`
`Neal R. Gross and Co., Inc.
`Washington DC
`
`www.nealrgross.com
`FlatWing Ex. 1045, p. 2
`
`
`
`3
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` CONTENTS
`WITNESS DIRECT CROSS REDIRECT RECROSS
`
`Paul Reider 4
`
`EXHIBIT NO. PAGE
`
`2013 Declaration prepared for IPR2018-
` 00168 . . . . . . . . . . . . . . . . . . .10
`2044 Dr. Reider's CV . . . . . . . . . . . . . .29
`2013 Declaration prepared for IPR2018-
` 00169 . . . . . . . . . . . . . . . . . . .58
`2013 Declaration prepared for IPR2018-
` 00170 . . . . . . . . . . . . . . . . . . .61
`2013 Declaration prepared for IPR2018-
` 00171 . . . . . . . . . . . . . . . . . . .66
`2028 Article by Wang . . . . . . . . . . . . . .72
`1020 Schematic Drawing . . . . . . . . . . . . .73
`1022 Biobor Material Safety Data Sheet . . . . .76
`2016 Hall 2001 reference . . . . . . . . . . . .81
`
`(202) 234-4433
`
`Neal R. Gross and Co., Inc.
`Washington DC
`
`www.nealrgross.com
`FlatWing Ex. 1045, p. 3
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` P-R-O-C-E-E-D-I-N-G-S
` 9:34 a.m.
`WHEREUPON,
` PAUL REIDER
`was called as a witness by Counsel for the
`Petitioner and, having been first duly sworn,
`assumed the witness stand, was examined and
`testified as follows:
` MR. SEGREST: And for appearances, I'm
`Philip Segrest representing the petitioner,
`FlatWing.
` MR. MILLS: I'm Jad Mills with Wilson,
`Sonsini, Goodrich, and Rosati representing
`petitioner Mylan.
` MR. SHEH: Tony Sheh of Williams and
`Connolly on behalf of Anacor. With me today is
`Aaron Maurer also of Williams and Connolly.
` DIRECT EXAMINATION
` BY MR. SEGREST:
` Q Good morning, Dr. Reider. Have you
`been deposed previously?
` A I have.
`
`(202) 234-4433
`
`Neal R. Gross and Co., Inc.
`Washington DC
`
`www.nealrgross.com
`FlatWing Ex. 1045, p. 4
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` Q And how many times have you given
`depositions?
` A I believe seven times. That may not
`be completely correct, but in the neighborhood.
` Q Have you ever testified at trial?
` A I have.
` Q How often?
` A That's also tricky to answer because
`in a Canadian suit, sometimes it appears to be in
`the format of a deposition, but could actually be
`considered a trial, but in an actual courtroom,
`twice.
` Q So what were the two times you've
`testified in a courtroom?
` A One was in the New Jersey District
`Court in Newark, Judge Rawls in the case of
`Janssen Pharmaceuticals v. Mylan. The patent was
`with regard to an HIV drug called Darunavir. The
`
` Q What was the other one?
` A The other one was a case that's called
`a Section 8 case, where I was advising the
`
`(202) 234-4433
`
`Neal R. Gross and Co., Inc.
`Washington DC
`
`www.nealrgross.com
`FlatWing Ex. 1045, p. 5
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`Canadian Federal Court on potential losses that
`Teva would have sustained or did sustain,
`hypothetical losses had they been allowed to come
`onto market with their generic equivalent of
`Lyrica. I guess its Gabapentin, and that may be
`incorrect.
` Lyrica is -- I actually don't recall
`the generic name for Lyrica, but the question was
`in a hypothetical world, when would they have
`reached market? When would Teva reach market?
`How much would they have sold and what percent of
`the market could they have fulfilled? So it was
`after an intellectual property case had been
`decided, and I was not involved in the IP case.
` Q When was the, when was your testimony
`in the Teva case?
` A I believe three years ago.
` Q And when was your testimony in the
`case with Mylan?
` A I believe it was four years ago.
` Q And in what matters have you given
`deposition testimony?
`
`(202) 234-4433
`
`Neal R. Gross and Co., Inc.
`Washington DC
`
`www.nealrgross.com
`FlatWing Ex. 1045, p. 6
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` A The first time I was deposed, I was
`deposed as a fact witness, and that would have
`been in the late 1990s, early 2000 time frame.
`The second case was also as a fact witness in a
`case of Merck v. Searle/Pfizer on the ownership
`of Vioxx and Celebrex.
` The next case, I believe, wow, then we
`start getting into the dorimeter cases, and there
`were cases in the U.S., Canada, Australia,
`Janssen v. Mylan on an AIDS drug called
`Rilpivirine, which settled before going to trial,
`the case of Leo Pharmaceutical v. Actavis that
`also settled before going to trial, the original
`Anacor cases, IPRs, and most recently on the case
`of Insight Pharma v. Concert Pharma where there
`was, I believe it's an IPR case that I was
`deposed in September.
` Q In how many of these matters were you
`testifying as an expert witness?
` A Every one except the very first two.
` Q When testifying as an expert, were you
`always testifying on the side of the patentee?
`
`(202) 234-4433
`
`Neal R. Gross and Co., Inc.
`Washington DC
`
`www.nealrgross.com
`FlatWing Ex. 1045, p. 7
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` A No.
` Q On which ones were you testifying on
`the side of the generic?
` A The most recent case, Insight.
` Q The Insight case?
` A Yes, I felt that the patent was
`obvious and I testified to that effect.
` Q So you're experienced about giving
`testimony, but I'll go over the procedures again
`for you. We've got a court reporter taking down
`what we say. I'll ask questions. You'll try to
`answer.
` I'll try not to interrupt you when
`you're answering, and we'll try not to speak over
`each other so she can take down what is said.
`You'll need to give verbal responses instead of
`gestures or nodding or shaking your head so that
`she can write it down.
` If at some point you need to take a
`break, let me know. I'll probably ask you to
`answer any question that may be pending, but we
`can take breaks as needed.
`
`(202) 234-4433
`
`Neal R. Gross and Co., Inc.
`Washington DC
`
`www.nealrgross.com
`FlatWing Ex. 1045, p. 8
`
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` This is testimony under oath. It's
`just like testifying at trial except that we
`don't have a court officer here to rule on
`objections.
` Your counsel may make objections from
`time to time, but unless there's a specific
`instruction not to answer, you need to go ahead
`and answer to the best of your ability, and a
`judge or somebody else will rule on those
`objections later.
` Is there anything you don't understand
`about the deposition procedure, any questions you
`have?
` A No, you were quite clear. Thank you.
` Q Okay, and is there any reason that you
`couldn't testify truthfully and accurately today?
` A Not that I know of.
` Q On any kind of medication or anything
`that could affect your memory or ability to
`testify?
` A No.
` MR. SEGREST: I'm going to hand you
`
`(202) 234-4433
`
`Neal R. Gross and Co., Inc.
`Washington DC
`
`www.nealrgross.com
`FlatWing Ex. 1045, p. 9
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`what is Exhibit 2013 and IPR 2018-00168.
` (Whereupon, the above-referred to
`document was marked as Petitioner Exhibit No.
`2013 for identification.)
` BY MR. SEGREST:
` Q Is this a declaration that you
`prepared for that IPR proceeding?
` A It is.
` Q Referring to paragraph one, does it
`indicate that this declaration contains your
`opinions related to the validity of claims three,
`five, and six of the 938 patent?
` A That's correct.
` Q Okay, now, I did not see an opinion on
`the ultimate question of obviousness. Does this
`declaration contain an opinion on obviousness?
` A I don't believe it does.
` Q Okay, does it contain an opinion as to
`the validity or invalidity of claims three, five,
`and six of the 938 patent?
` A In the specific document, I have
`expressed what I believe a person of skill in the
`
`(202) 234-4433
`
`Neal R. Gross and Co., Inc.
`Washington DC
`www.nealrgross.com
`FlatWing Ex. 1045, p. 10
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`art -- I use POSA. I hope that's okay.
` Q That's fine. When you use POSA, what
`do you mean?
` A A person of skill in the art. I
`believe some people use POSITA. The declaration
`and my conclusions are pretty clear with regard
`to my view that the claims are valid. I don't
`know that I -- when it comes to legal
`conclusions, I don't draw legal conclusions. I'm
`not an attorney.
` I do state in a number of places why,
`especially in response to the petitioner's
`grounds and at the conclusions of my report, why
`I believe that a person of skill in the art would
`have not arrived at the claimed amount of
`tavaborole through routine experimentation, and
`if one looks at the specific claims you've spoken
`about, my conclusion is that they're valid.
` Q Okay, where does it state that
`conclusion?
` A I don't know that it states in those
`words a legal opinion, but I certainly feel that,
`
`(202) 234-4433
`
`Neal R. Gross and Co., Inc.
`Washington DC
`www.nealrgross.com
`FlatWing Ex. 1045, p. 11
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`as we look through the individual claims which
`are recited on page six of my report, for
`example, claim three, the method of claim one
`wherein the pharmaceutical composition is in the
`form of a solution comprising five percent weight
`rate of compound tavaborole, that my belief is
`that it's a valid claim, and that whether by
`routine experimentation or by combining
`references found in the previous, in the prior
`art as of 2005, a person of skill in the art
`would not have been able to come up with this
`invention.
` Q But you don't ever say that in the
`declaration actually?
` A I'm not an attorney.
` Q But I'm just asking what's in the
`declaration. You never expressed that opinion in
`the declaration, right?
` A I don't believe that in those words I
`ever comment on obviousness.
` Q Okay, referring back to the same
`Exhibit 2013, does the second paragraph indicate
`
`(202) 234-4433
`
`Neal R. Gross and Co., Inc.
`Washington DC
`www.nealrgross.com
`FlatWing Ex. 1045, p. 12
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`that you're being compensated at your customary
`hourly rate?
` A Yes.
` Q Okay, when were you retained?
` A I actually can't recall. The
`transition when Pfizer bought Anacor occurred
`after my original work on the Anacor IPRs that
`were, I think we've mentioned. I would think in
`2017, but I could be off by a number of months.
`I assume when you said, "When were you retained?"
`you're referring to these patents, the patents at
`issue?
` Q Yes, was there a separate retainer
`agreement -
` A There was.
` Q - for your services on the four IPRs
`that we're here about today?
` A There was a separate retainer
`agreement with Williams and Connolly.
` Q And, but you're not sure exactly when
`
` A No.
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`(202) 234-4433
`
`Neal R. Gross and Co., Inc.
`Washington DC
`www.nealrgross.com
`FlatWing Ex. 1045, p. 13
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` Q -- you entered into that? What is
`your hourly rate?
` A It's $750 an hour.
` Q And is that the same hourly rate you
`charged in the other matters at which you've
`testified as an expert?
` A It was at one point $725 an hour about
`five years ago, and then a few years ago, it was
`raised for everybody I work with for all matters
`to $750.
` Q And how many hours have you billed
`working on these four IPRs?
` A I have no idea. I would actually have
`to speak to, you know, go over my records or
`speak to an accountant.
` Q Okay, do you know how much you've been
`paid for the declarations that you did?
` A No, generally when we get to April and
`filing of taxes, I have a vague idea, but I don't
`follow that during the year.
` Q Now, do paragraphs three and four in
`the declaration list materials that you
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`(202) 234-4433
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`Neal R. Gross and Co., Inc.
`Washington DC
`www.nealrgross.com
`FlatWing Ex. 1045, p. 14
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`considered?
` A They list some of the materials that
`I've considered.
` Q Okay, so do they list the other
`declarations that have been submitted in these
`IPRs?
` A They do.
` Q And they also refer to the exhibits
`and articles cited in those declarations and
`cited in your own declaration?
` A That's correct.
` Q Were there any other materials that
`you considered that aren't listed here?
` A There may have been in generating my
`declaration.
` Q What other materials did you consider?
` A Oh, I think the literature searches
`that I did with regard to this case or these
`cases would generally have included materials
`that fell outside the relevant time frame of
`2005. This is work done. Occasionally you do a
`literature search.
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`(202) 234-4433
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`Neal R. Gross and Co., Inc.
`Washington DC
`www.nealrgross.com
`FlatWing Ex. 1045, p. 15
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` I'm sure you're aware that you'll see
`references and often in those references, there
`will be, for example, reviews that will have
`post-2005 dates, so I may have decided that they
`would not be cited in my declaration.
` Q Did you review your declarations from
`the previous Anacor IPRs?
` A Briefly.
` Q Did you review your depositions from
`those matters?
` A Only in the time frames shortly after
`the depositions for accuracy and then for self-
`training, if you will, to understand, for me to
`understand how the deposition went.
` Q And did you consider those previous
`declarations and depositions in preparing the
`declarations in these four IPRs?
` A In the sense that I have accepted the
`Board's ruling.
` Q Did you review the final written
`decisions in those three previous IPRs?
` A I believe I reviewed the Board's
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`(202) 234-4433
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`Neal R. Gross and Co., Inc.
`Washington DC
`www.nealrgross.com
`FlatWing Ex. 1045, p. 16
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`decisions and the federal -- the court's decision
`on the appeal.
` Q And so for purposes of these four
`IPRs, are you accepting the, or, yeah, accepting
`as given the determinations made previously by
`the Board and the Federal Circuit with respect to
`the subject matter?
` A I am.
` Q What is paragraph five in your
`declaration referring to?
` A My understanding is that in a
`proceeding like this, that new material that I
`will not have had a chance to review at this
`point could be entered into the record, so as it
`states there, I further reserve the right to
`expand or otherwise modify my opinions and
`conclusions as my investigation and study
`continues and to supplement my opinions and
`conclusions in response to any additional
`information that becomes available to me.
` Q What's the basis for your
`understanding?
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`(202) 234-4433
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`Neal R. Gross and Co., Inc.
`Washington DC
`www.nealrgross.com
`FlatWing Ex. 1045, p. 17
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` A This is from discussions with counsel.
` Q Did you at this time have any other
`testimony you were planning on giving in this
`action other than what's in your declarations and
`your depositions today or your deposition today?
` A Not to my knowledge.
` Q Now, does paragraph four indicate that
`you're also aware of knowledge generally
`available to and relied upon by persons of
`ordinary skill in the art at the time of the
`invention?
` A I state that I am also aware of
`knowledge generally available to and relied upon
`by persons of ordinary skill in the art at the
`time of the invention.
` Q And does your declaration ever say
`what the level of ordinary skill in the art is?
` A It does not. I actually have, I
`believe, in previous declarations covered the
`definition of a POSA, but in reading both Dr.
`Kahl and Dr. Murthy's declarations, especially
`Dr. Kahl's, I find my definition and his are
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`(202) 234-4433
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`Neal R. Gross and Co., Inc.
`Washington DC
`www.nealrgross.com
`FlatWing Ex. 1045, p. 18
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`almost the same, and I will accept his
`definition.
` Q Did you review the institution
`decisions in these four IPRs?
` A I don't know if you can show it to me.
`I'll see if I recognize the - the institution is
`different from the Board? An IPR is an
`institutional proceeding, so these are the three
`rulings from the IPR?
` Q That's not what I'm referring to.
` A Okay.
` Q I will hand you what I'm talking
`about. These are the decisions in this case.
`This is paper number nine, the decision to
`institute in IPR2018-00168
` A Yes.
` Q -- which I think is the
` A I'm sorry. I understand what you're
`referencing.
` Q Well, let me -- I'll give it to you.
`So did you review that document?
` A I believe I have.
`
`(202) 234-4433
`
`Neal R. Gross and Co., Inc.
`Washington DC
`www.nealrgross.com
`FlatWing Ex. 1045, p. 19
`
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` Q And do you understand that's the
`decision to institute the IPR in the same IPR
`number that you submitted the declaration in that
`we've been looking at?
` A This would be 00168, 00169, 00170, and
`00171?
` Q Right, so those are the four IPRs that
`you've submitted declarations in?
` A Yes.
` MR. SHEH: Objection to form.
` MR. SEGREST: I'm sorry?
` MR. SHEH: Objection to form.
` MR. SEGREST: Okay.
` THE WITNESS: I believe at the
`beginning of my involvement with these cases that
`I did review these. I have not reviewed them
`since, but is there a date of the
` BY MR. SEGREST:
` Q Well, if you look on the cover page up
`in the upper right-hand corner
` A Yeah.
` Q - do you see the indication, "paper
`
`(202) 234-4433
`
`Neal R. Gross and Co., Inc.
`Washington DC
`www.nealrgross.com
`FlatWing Ex. 1045, p. 20
`
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`number nine" and "entered June 8, 2018"?
` A Yes, I do.
` Q So you said that was towards the
`beginning. Does that refresh your recollection
`at all as to when you were retained in these
`matters?
` A It does not.
` Q Do you know if you were retained
`before or after June 8?
` A I do not.
` Q If I can direct your attention to page
`six?
` A I'm there.
` Q And do you see the heading "person of
`ordinary skill in the art"?
` A I do.
` Q And is the definition of the person of
`ordinary skill in the art that's given in those
`paragraphs substantially similar to the
`definition that you have applied in your
`declarations?
` MR. SHEH: Objection to the form.
`
`(202) 234-4433
`
`Neal R. Gross and Co., Inc.
`Washington DC
`www.nealrgross.com
`FlatWing Ex. 1045, p. 21
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` THE WITNESS: This actually is very
`similar to Dr. Kahl's definition of a person of
`skill in the art, which I said I was comfortable
`with.
` BY MR. SEGREST:
` Q Okay, so for purposes of your
`testimony as an expert here, what are you an
`expert in?
` A So if we're going to get - I have a
`few piles of documents just for logistical
`purposes. Are you done with this document for
`now?
` Q Yes, you can set that up here on the
`table if you want.
` A Okay.
` Q Keep it within reach since it's one
`that I've handed to you, but I don't have another
`question about it right at this point.
` A Okay, so we don't have Bates numbers
`and we don't have -- well, we have exhibit
`numbers.
` Q We have exhibits numbers and most of
`
`(202) 234-4433
`
`Neal R. Gross and Co., Inc.
`Washington DC
`www.nealrgross.com
`FlatWing Ex. 1045, p. 22
`
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`the exhibits will have page numbers.
` A Perfect, so I have actually stated in
`the report, if you look at paragraph nine on page
`three, that prior to coming to Princeton in my
`role in the pharmaceutical industry, I was
`responsible for chemistry, small molecule drug
`discovery, including medicinal chemistry,
`analytical chemistry, sample collection, compound
`procurement, computational chemistry, molecular
`modeling, protein chemistry, automation and
`robotics, crystallography, process chemistry,
`peptide chemistry, and high-throughput screening.
`I actually feel that having been responsible for
`those functions, I have expertise. I'm an expert
`in those areas.
` I believe I go on in paragraph 11 to
`discuss that I have extensive experience with
`boron-containing catalysts and reactants in the
`synthesis of potential drug candidates, and that
`although I've never developed boron-containing
`compounds for use as drug candidates themselves,
`my experience with boron compounds as well as my
`
`(202) 234-4433
`
`Neal R. Gross and Co., Inc.
`Washington DC
`www.nealrgross.com
`FlatWing Ex. 1045, p. 23
`
`
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`knowledge of boron chemistry and medicinal
`chemistry are sufficient for me to offer opinions
`on boron-containing pharmaceutical drugs and
`compositions.
` Q Okay, are you offering any opinions on
`crystallography?
` A I am.
` Q Okay, where in this declaration are
`your opinions on crystallography?
` A So if you turn to page 24 of my
`declaration, at the end of paragraph 60, I am
`referring to the structures of boron-containing
`compounds and their intramolecular hydrogen-
`bonded nature. The illustration there is a
`crystal structure of a hydrogen-bonded dimer. I
`don't know if you can see it.
` I say, "A person of skill in the art
`would have so appreciated tavaborole's penchant
`for intermolecular hydrogen bonding based on
`benzoboroxole's crystallization as a hydrogen-
`bonded dimer depicted below."
` Q Okay, so when you said
`
`(202) 234-4433
`
`Neal R. Gross and Co., Inc.
`Washington DC
`www.nealrgross.com
`FlatWing Ex. 1045, p. 24
`
`
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`crystallography, were you referring to this kind
`of depiction of a crystal?
` A When you asked if I was expressing
`opinions on crystallography?
` Q Well, you said crystallography was
`part of the scope of your expertise, that you're
`qualified as an expert and that you're being
`offered as an expert on it in these matters, so
`is this what you meant by crystallography?
` MR. SHEH: Objection to form.
` THE WITNESS: I don't think that's
`what I said, counselor. I think I said - you
`asked me what my areas of expertise were and that
`included crystallography, and that you asked, "Is
`crystallography an area that you've opined on in
`this report?" and then you asked me to point out
`where, and to be inclusive and thorough, I tried
`to point out that I have opined on a crystal
`structure in this report.
` BY MR. SEGREST:
` Q Okay, is there anything about x-ray
`diffraction study of crystallography or any of
`
`(202) 234-4433
`
`Neal R. Gross and Co., Inc.
`Washington DC
`www.nealrgross.com
`FlatWing Ex. 1045, p. 25
`
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`that type of material in this report?
` A No.
` Q And maybe my question before wasn't
`clear, so what I was asking for is what is the
`scope of the expertise on which you are being
`offered as an expert in these matters to give
`your opinions?
` MR. SHEH: Objection to form.
` THE WITNESS: So in forming my
`opinions, I tried to point out the literature and
`the documents in the record of this case, and the
`documents I reviewed, but my opinions, my
`expertise is informed by 30 years of experience,
`and I tried to be inclusive as to the areas that
`I have -- I'm an expert in or have expertise in.
` There are many other areas that I've
`been involved in throughout the course of my
`career which we may or may not discuss, but I
`tried to, at least in the introduction, cover the
`areas that I had direct ownership of.
` BY MR. SEGREST:
` Q Okay, and, you know, we'll go over
`
`(202) 234-4433
`
`Neal R. Gross and Co., Inc.
`Washington DC
`www.nealrgross.com
`FlatWing Ex. 1045, p. 26
`
`
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`some more of your background in more detail, but
`at this point, I'm asking what are you being
`proffered as an expert in to give your testimony
`on?
` When the court rules that you are
`qualified as an expert to give opinions on a
`subject or not, what is the subject on which
`you're being offered as an expert?
` MR. SHEH: Objection to form.
` THE WITNESS: So I believe that would
`include the areas I've listed to form my
`opinions. They would be focused on both
`medicinal and process chemistry. I have a Ph.D.
`in organic chemistry, and specifically in
`discussions of boron-containing compounds.
` BY MR. SEGREST:
` Q Are you being offered as an expert on
`boron chemistry?
` A I believe I'm being offered as an
`expert on organic boron compounds, organoboranes.
` Q Does paragraph nine describe your work
`at Amgen?
`
`(202) 234-4433
`
`Neal R. Gross and Co., Inc.
`Washington DC
`www.nealrgross.com
`FlatWing Ex. 1045, p. 27
`
`
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` A It does.
` Q During your time at Amgen, did you
`develop any products that received FDA approval?
` A I did.
` Q And what were those?
` A The small molecule, the only small
`molecule that Amgen has received FDA approval for
`is cinacalcet.
` Q Can you spell that?
` A C-I-N, I believe, A-C -- may I have a
`pen?
` Q Here you go.
` A Thank you. Actually, I don't know.
` Q I tell you what -
` A I'm going to give you the brand name.
`It's easier.
` Q Okay.
` A It's Sensipar, S-E-N-S-I-P-A-R.
` Q We'll look up the spelling on the
`other name.
` A Generic names are notoriously hard to
`spell.
`
`(202) 234-4433
`
`Neal R. Gross and Co., Inc.
`Washington DC
`www.nealrgross.com
`FlatWing Ex. 1045, p. 28
`
`
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` Q Now, and you may have already
`mentioned this, referring to paragraph 11, does
`this indicate that you have never developed
`boron-containing compounds for use as drug
`candidates?
` A There are, to my knowledge, only three
`FDA approved boron-containing drugs. I have not
`been involved in any of those three. In 2005,
`there was only one. Velcade was discovered by my
`former colleague from Merck, Julian Adams. So,
`no, I never have been involved with any of those
`three molecules.
` MR. SEGREST: I'm handing you what was
`marked Exhibit 2044.
` (Whereupon, the above-referred to
`document was marked as Petitioner Exhibit No.
`2044 for identification.)
` BY MR. SEGREST:
` Q Do you recognize this document?
` A I do.
` Q And what is it?
` A It appears to be a current version of
`
`(202) 234-4433
`
`Neal R. Gross and Co., Inc.
`Washington DC
`www.nealrgross.com
`FlatWing Ex. 1045, p. 29
`
`
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`my curriculum vitae.
` Q And as of what date is it current?
` A Probably updated the end of 2017.
` Q How many publications are listed on
`it?
` A 182.
` Q And how many patents are listed on it?
` A I don't know. Someone once did a
`search of my patents, issued patents, and I
`believe there are over 35, but I don't know that
`they're on my CV.
` Q Well, I'll direct you to pages 19 and
`20. Does it list 30 patents?
` A It does.
` Q How many of those publications and
`patents relate to boron-containing compounds?
` A Under the publications and the use of
`boron, as I state that I have experience with
`boron-containing catalysts and reactants in the
`synthesis, I would say 60 or 70 of these
`publications. I've highlighted ones that are, I
`think, the most relevant to these patents.
`
`(202) 234-4433
`
`Neal R. Gross and Co., Inc.
`Washington DC
`www.nealrgross.com
`FlatWing Ex. 1045, p. 30
`
`
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` Q Which ones have you highlighted as
`being most relevant to these patents?
` A I highlighted the work on leukotriene
`antagonists with Joe McNamara and where we
`discovered that the, if you will, the intrinsic
`properties of boron-containing molecules to bind
`promiscuously when we were using boron catalysts
`in our attempt to synthesis leukotriene
`antagonists.
` Q Are your publications numbered in your
`CV?
` A They are.
` Q And which publication number are you
`referring to?
` A So the easiest way is to look at the
`years. So in my report, I would have actually
`indicated the year of the McNamara paper, which
`is 1989, the Journal of Organic Chemistry. On
`page 17 of my CV, I reference 13, the synthesis
`of unsymmetrical dithioacetals.
` Q Okay, you said before you've
`highlighted the publications that related to
`
`(202) 234-4433
`
`Neal R. Gross and Co., Inc.
`Washington DC
`www.nealrgross.com
`FlatWing Ex. 1045, p. 31
`
`
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`boron-containing compounds. Did you mean that
`there were some mark, or formatting, or other
`highlighting on your CV that indicated which
`publications relate to boron?
` A No, by the citation within my report.
`As I indicated in paragraph 30, my own experience
`working with boron demonstrates the practical
`implication of boron's promiscuous nature.
` "In attempting to develop a sufficient
`synthesis of unsymmetrical dithioacetal compounds
`at Merck, we discovered that boron trifluoride
`etherate proved to be an excellent Lewis acid
`capable of catalyzing the reaction without
`leading to unwanted conjugate addition."
` And then I go on to
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