`
`Date: May 4, 2016
`
`Case: Lupin Ltd. and Lupin Pharmaceuticals Inc. v. Senju
`Pharmaceutical Co., Ltd., Bausch & Lomb, Inc., and Bausch & Lomb
`Pharma Holdings Corp.
`
`Ace-Federal Reporters, Inc.
`Phone: 202-347-3700
`Fax: 202-737-3638
`Email: info@acefederal.com
`Internet: www.acefederal.com
`
`SENJU EXHIBIT 2343
`LUPIN v SENJU
`IPR2015-01099
`
`PAGE 1 OF 115
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`Ivan T. Hofmann - May 4, 2016
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`Page 1
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` UNITED STATES PATENT AND TRADEMARK OFFICE
` ____________________________________________________
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________________________________________________
` LUPIN LTD., and LUPIN PHARMACEUTICALS INC.
` Petitioners,
` v.
`SENJU PHARMACEUTICAL CO., LTD., BAUSCH & LOMB, INC.,
` and BAUSCH & LOMB PHARMA HOLDINGS CORP.,
` Patent Owners.
` ____________________________________________________
` Inter Partes Review Nos.
` IPR2015-01097 (Patent 8,754,131)
` IPR2015-01099 (Patent 8,669,290)
` IPR2015-01100 (Patent 8,927,606)
` IPR2015-01105 (Patent 8,871,813)
`____________________________________________________
`
` CONFIDENTIAL DEPOSITION OF IVAN T. HOFMANN
` Washington, DC
` Wednesday, May 4, 2016
` REPORTED BY: SARA WICK, RPR, CRR
`
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`Page 2
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` Confidential Deposition of IVAN T. HOFMANN,
` called for examination pursuant to notice of
` deposition on Wednesday, May 4, 2016, in Washington,
` DC, at the offices of Crowell & Moring LLP, 1001
` Pennsylvania Avenue, NW, at 9:02 a.m., before SARA
` WICK, RPR, CRR and a Notary Public within and for
` the District of Columbia, when were present on
` behalf of the respective parties:
`
` SHANNON M. LENTZ, ESQ.
` VINCENT J. GALLUZZO, ESQ.
` Crowell & Moring LLP
` 1001 Pennsylvania Avenue, NW
` Washington, DC 20004-2595
` 202-624-2897
` slentz@crowell.com
` vgalluzzo@crowell.com
` On behalf of Petitioner
`
` -- continued --
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`Ivan T. Hofmann - May 4, 2016
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` APPEARANCES (Continued):
`
`Page 3
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` JUSTIN J. HASFORD, ESQ.
` Finnegan, Henderson, Farabow, Garrett
` & Dunner, L.L.P.
` 901 New York Avenue, NW
` Washington, DC 20001-4413
` 202-408-4175
` justin.hasford@finnegan.com
` On behalf of Patent Owner
`
` ALSO PRESENT: Lisa Hines, Jonathan Perry
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`Page 4
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` P R O C E E D I N G S
` VIDEOGRAPHER: This is disk number 1 in
` the video deposition of Ivan T. Hofmann.
` My name is Jonathan Perry. I'm
` representing Ace-Federal Reporters, located at 1625
` I Street Northwest, in Washington, D.C. Today's
` date is May 4th, 2016. The time is approximately
` 9:02 a.m. We are at the offices of Crowell & Moring
` located at 1001 Pennsylvania Avenue Northwest, in
` Washington, D.C.
` The deposition is being taken in the
` matter of Lupin, et al., versus Senju, et al.,
` before the Patent Trial and Appeal Board, U.S.
` Patent and Trademark Office, relating to Cases
` IPR2015-01100 and IPR-2015-010097 and IPR2015-01099
` and IPR2015-01105.
` Will counsel present, please, introduce
` themselves and state who they represent.
` MR. HASFORD: Justin Hasford for Finnegan,
` on behalf of Patent Owner Senju, and with me is my
` colleague, Lisa Hines.
` MS. LENTZ: Shannon Lentz with Crowell &
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` Moring on behalf of Petitioners. With me is my
` colleague, Vince Galluzzo, also with Crowell.
` VIDEOGRAPHER: Our court reporter is Sara
` Wick, also with Ace-Federal Reporters.
` Will you, please, swear in the witness.
` Whereupon,
` IVAN T. HOFMANN
` was called as a witness and, having first been duly
` sworn, was examined and testified as follows:
` CROSS-EXAMINATION
` BY MR. HASFORD:
` Q Good morning, Mr. Hofmann.
` A Good morning, Mr. Hasford.
` Q Would you, please, state your name and
` address for the record.
` A Sure. My name is Ivan T. Hofmann, and I
` live at 169 South Ridge Drive, Cranberry Township,
` Pennsylvania 16066.
` Q Mr. Hofmann, I represent the Patent Owner,
` Senju, in these IPR proceedings. Today, I will ask
` you questions, and I would ask that you answer my
` questions truthfully and accurately.
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` If you need a break, just let me know, but
` if a question is pending, please first answer the
` question, and then we can take a break.
` If for any reason you do not understand a
` question that I ask, please let me know. If you
` answer a question, I will assume that you understood
` the question.
` Is that okay?
` A I will do my best.
` Q Is there any reason why you cannot testify
` truthfully and accurately today?
` A No, sir.
` MR. HASFORD: For the record, I'm handing
` Mr. Hofmann and Petitioner's counsel Exhibits 2332
` and Exhibit 2333. Exhibit 2332 is Patent Owner's
` notice of cross-examination of Ivan T. Hofmann in
` IPR2015-01099, and Exhibit 2333 is Patent Owner's
` notice of cross-examination of Ivan T. Hofmann in
` IPR2015-01097, 01100, and 01105.
` (Exhibits 2332 and 2333 marked for
` identification.)
` MR. HASFORD: Counsel, can we stipulate
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` that Mr. Hofmann is here today pursuant to Exhibits
` 2332 and 2333?
` MS. LENTZ: Yes, we can.
` MR. HASFORD: Okay. We can put that
` aside. Can we also stipulate that the questions
` that I ask, unless otherwise stated, apply equally
` to IPR2015-01097, IPR2015-01099, IPR2015-01100 and
` IPR2015-01105?
` MS. LENTZ: Yes, we can.
` MR. HASFORD: Thank you. For the record,
` I'm handing Mr. Hofmann and Petitioner's counsel a
` copy of Exhibit 1122, which is entitled "DECLARATION
` OF IVAN T. HOFMANN, CPA/CFF, CLP."
` (Exhibit 1122 marked for identification.)
` BY MR. HASFORD:
` Q Is Exhibit 1122 your declaration in these
` IPR proceedings concerning U.S. patent numbers
` 8,669,290, 8,754,131, 8,871,813, and 8,927,606?
` A It appears to be, yes.
` Q Do you have any reason to believe that
` it's not?
` A No, sir.
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` Q Please turn to page -- there's going to be
` two page numbers on here. There's a page 82 in the
` lower right-hand corner and a page 80 at the bottom
` center, but it's the last page of your declaration
` that includes -- paragraph 121 that includes a date
` and includes a signature. Let me know when you're
` there.
` A I'm there.
` Q How would you like me to identify the page
` numbers of your declaration, sir, given that there's
` two different page numbers on them?
` A Probably the center page number would be
` most helpful to me.
` Q So center page 80 of your declaration, do
` you see your electronic signature on that page?
` A I do.
` Q You did not actually write your
` declaration for these IPR proceedings; correct?
` A I did write my declarations for these IPR
` proceedings.
` Q Why is your signature electronic instead
` of ink?
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` A I was out of the office that day.
` Q Turn, if you would, to the page that says
` page 88 at the lower right-hand portion of the page
` in Exhibit 1122.
` A Okay.
` Q Is that a copy of your curriculum vitae?
` A It is.
` Q Is your full curriculum vitae only one
` page?
` A Well, I would reference the sections of
` the report, both in the introduction and in III. So
` the CV is one page in terms of a high-level CV. I
` and III of my report contain a more tailored
` description of my background and experience, and of
` course, in addition to the information in the CV, I
` believe that my testimony under 26(a)(2) was also
` produced, which lays out my testifying experience
` for the last four years.
` Q You mentioned 26(a)(2). What do you mean
` by that?
` A My understanding is under the Federal
` Rules of Civil Procedure, that there is certain
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` disclosures that are typically made, and they
` include testifying as an expert over the last four
` years, identification of those cases where I've
` provided testimony.
` Q Do you know what the standards are for
` inter partes review proceedings before the U.S.
` Patent and Trademark Office?
` A I'm not an expert in those rules and regs,
` no.
` Q Let's take a look at your CV. Take a
` look, if you would, at the section that
` says "Education and Certification." Have you
` received any degrees besides a bachelor of business
` administration from the University of Notre Dame?
` A No. In terms of formal education, I just
` have the bachelor degree in business administration
` with a dual major in economics and accounting. I,
` of course, obtained continuing education for the
` last 20 years each and every year.
` Q You have never obtained a master's degree;
` correct?
` A No, sir.
`
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` Q You have never obtained a Ph.D. degree;
` correct?
` A That's correct.
` Q You have never obtained a law degree; is
` that correct?
` A That's correct.
` Q You are not a named inventor on any
` patents; correct?
` A I am not.
` Q You are not a named inventor on any patent
` applications; correct?
` A That's correct.
` Q You have never marketed a pharmaceutical
` product for a pharmaceutical company; correct?
` A Not directly, no. I've certainly
` consulted with pharmaceutical companies in the areas
` involving pharmaceutical product pipeline consulting
` and the like.
` Q Do you remember testifying under oath at a
` deposition in the parallel district court
` proceeding, sir?
` A Yes, sir.
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` MR. HASFORD: For the record, I'm handing
` Mr. Hofmann and Petitioner's counsel copies of
` Exhibit 2334. For the record, Exhibit 2334 is a
` transcript of the sworn testimony of Ivan Hofmann,
` taken February 24th, 2016.
` (Exhibit 2334 marked for identification.)
` THE WITNESS: Thank you, sir.
` BY MR. HASFORD:
` Q Turn, if you would, to page 16. Let me
` direct your attention to lines 6 through 8. You
` were asked:
` "Question: Have you ever actually
` marketed a pharmaceutical product for a
` pharmaceutical company?"
` And you answered "No. My work has been as
` a consultant."
` That was the exact question that you were
` asked, and that was the exact sworn testimony that
` you gave; correct?
` A Those line and then the lines that
` continue. "Have you ever worked on a marketing
` campaign?" "No, not directly." That's exactly what
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` I answered to you moments ago.
` Q That was your sworn testimony; correct,
` sir?
` A Correct. I mean --
` Q Were you testifying truthfully that day?
` A Of course. And --
` Q You may put that aside.
` A -- consistent with my answer a few moments
` ago.
` Q You have never formulated a pharmaceutical
` product; correct?
` A I am not a formulator, no.
` Q You have never conducted any scientific
` research on a pharmaceutical product; correct?
` A No scientific research, no.
` Q You are not an expert in any field of
` medicine; correct?
` A I am not an expert in the field of
` medicine. I certainly am an expert in
` pharmaceutical economics, which medicine has
` implications with respect to pharmaceutical
` economics.
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` Q Look back at your deposition transcript,
` sir.
` A Okay.
` Q Page 20, line 4 to 6.
` A Yes.
` Q You were asked:
` "Question: You're not an expert in any
` field of medicine, correct?" And you answered "No."
` That was the exact question that you were
` asked, and that was the exact answer that you gave;
` correct?
` A Correct, consistent with the answer I just
` gave you.
` Q I didn't ask whether it was consistent
` with the answer you gave. I asked that was the
` exact question that you were asked and that was the
` exact answer that you gave. Correct?
` A Correct, consistent with the last answer I
` gave you.
` Q You can put that aside. You have never
` prescribed any medication to a patient; correct?
` A I have not.
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` Q You have never treated an inflammatory
` disease of the eye; correct?
` A That's correct.
` Q You have never administered any medication
` to a patient; correct?
` A I mean, other than my children, no.
` Q You are not an expert in chemistry;
` correct?
` A That's correct.
` Q In connection with your opinions in this
` case, you did not do any laboratory testing of any
` pharmaceutical formulations; correct?
` A No, sir.
` Q In connection with your opinions in this
` case, you never considered or conducted any testing
` to assess Prolensa; correct?
` MS. LENTZ: Objection; vague.
` THE WITNESS: Can you repeat that? I'm
` not certain I understand the question.
` BY MR. HASFORD:
` Q In connection with your opinions in this
` case, you never considered or conducted any testing
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` on Prolensa; correct?
` MS. LENTZ: Same objection.
` THE WITNESS: I didn't conduct any
` testing. I certainly reviewed technical expert
` reports, which may have been included consideration
` of testing, but that's it.
` BY MR. HASFORD:
` Q Let's take a look at your CV again.
` A Okay.
` Q Okay. It says from 1994 to 2006 you were
` employed at Deloitte & Touche as a senior manager.
` Do you see that?
` A Yes.
` Q What were your responsibilities as a
` senior manager at Deloitte & Touche?
` A Generally, I worked in the assurance and
` advisory department conducting audits of public and
` private companies. In my time there, I transitioned
` over to the forensic and dispute services practice,
` which included, you know, litigation support of
` financial and economic issues in litigation.
` Q What sorts of clients did you represent at
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` Deloitte & Touche?
` A I think a broad range of companies, both
` public and private, manufacturing, healthcare,
` telecom, et cetera.
` Q What were some of the healthcare projects,
` generally speaking, that you worked on at Deloitte &
` Touche?
` A There were a variety of hospital clients,
` systems, regional healthcare systems, and I also did
` some work for Mylan Pharmaceuticals.
` Q How many times have you served as an
` expert in pharmaceutical patent cases?
` A Those which have matured into testimony or
` just more broadly?
` Q Well, let's start with those which have
` matured into testimony. How many times have you
` served as an expert -- well, strike that and try
` again.
` How many times have you served as a
` testifying expert in pharmaceutical patent cases?
` A Dozens and dozens.
` Q Have you ever served as a testifying
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` expert on behalf of a branded drug company in a
` pharmaceutical patent case?
` A Sure.
` Q Have you ever testified in a
` pharmaceutical patent case that a pharmaceutical
` product is commercially successful?
` A Well, that's complicated in terms of a lot
` of the cases that I have that didn't mature into
` testimony in open court are subject to protective
` orders and limitations and the like --
` Q I'm not asking about anything that's under
` a protective order. I'm asking about testimony
` that's actually been in open court. Have you ever
` testified in a pharmaceutical patent case that a
` pharmaceutical product is commercially successful?
` A I think in my work I've done -- I have
` testified on behalf of patent owners with respect to
` certain prescription nutraceutical products,
` concerning the commercial success of those products.
` Q That wasn't my question, sir.
` Pharmaceutical patent cases. You understand what a
` pharmaceutical is; right?
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` A Sure.
` Q Okay. In pharmaceutical patent
` infringement cases, have you ever testified on
` behalf of the Patent Owner that a pharmaceutical
` product is commercially successful?
` A Thinking of those that have matured into
` testimony in open court, I don't know that they have
` included the Patent Owner involving those
` assertions.
` Q I looked for them, and I couldn't find
` any. Does that surprise you?
` A That's not surprising. Like I said, those
` that have matured into testimony are a much limited
` population compared to those -- the broad work that
` I've done in this space.
` Q Yet, you testified that you've provided
` testimony in dozens and dozens of pharmaceutical
` patent cases; correct?
` A There's a distinction there. I've
` provided testimony at deposition, which is still
` under protective order, which I can't get into.
` There's a distinction. Those that have actually
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` matured into testimony in open court are much more
` limited.
` Q Why do you suppose they're much more
` limited?
` A It's rare that cases go all the way to
` trial and open court.
` Q Do you think that had anything to do with
` the opinions that you were providing?
` A No. If anything, the situations -- and
` most recently the situations I've had is where
` patent owners have dropped commercial success
` because, I think, the strength of my opinions, and
` therefore, I didn't end up testifying in those
` cases. So in some ways, yes, it's a factor of my
` opinion, but because of the strength of the opinion,
` not any other suggestion.
` Q You are not an expert in pharmaceutical
` formulations; correct?
` A Not in any technical way, no.
` Q You are not an expert in ophthalmic
` formulations; correct?
` A Not in any technical way, no.
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`Ivan T. Hofmann - May 4, 2016
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` Q You are not an expert in the manufacture
` of pharmaceuticals; correct?
` A Not in any technical way, but I'm
` certainly familiar with economic costs associated
` with manufacturing pharmaceutical products.
` Q Just to be clear, you are not an expert in
` the manufacture of pharmaceuticals; correct?
` A Not in any technical way.
` Q You are not an expert in methods of using
` pharmaceutical products; correct?
` A Certainly not as a prescriber, medical
` doctor, or technical expert, no, but I have a deep
` understanding of the use of prescription
` pharmaceutical products and the economic
` implications thereof.
` Q Just to be clear, you are not a technical
` expert in the methods of using pharmaceutical
` products; correct?
` A Not a technical expert, no.
` Q You are not an expert in FDA regulations
` regarding pharmaceutical products; correct?
` A There again, I think I have a deep
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`Ivan T. Hofmann - May 4, 2016
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` understanding of the pharmaceutical economics
` associated with FDA regulation, the role that the
` FDA plays in regulating prescription pharmaceutical
` products. I am not a legal or technical expert in
` terms of the regulatory rules and rulemaking that
` exists with respect to FDA regulation.
` Q You have never been qualified by any court
` or by the U.S. Patent and Trademark Office as an
` expert in FDA regulations regarding pharmaceutical
` products; correct?
` A Not in any technical way, no.
` Q You have never consulted for the FDA on
` any topic; correct?
` MS. LENTZ: Objection; vague.
` THE WITNESS: I don't think I have. I've
` done work for the U.S. PTO, but not the FDA.
` BY MR. HASFORD:
` Q Do you understand that the U.S. PTO and
` the FDA are different regulatory agencies?
` A Of course, but they're all under the
` umbrella of the U.S. government.
` Q You're not an expert in the clinical
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`Ivan T. Hofmann - May 4, 2016
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` benefits of pharmaceutical products; correct?
` A Well, I mean, typically, I do rely on
` clinicians with respect to clinical benefits, but
` certainly, in the work that I've done and the
` pharmaceutical economic implications of clinical
` benefits, I've studied and analyzed documents,
` testimony, and information with respect to the
` economic implications of alleged clinical benefits
` of products on a regular basis.
` Q You have never been qualified by any court
` or by the U.S. Patent and Trademark Office as an
` expert in clinical benefits of pharmaceutical
` products; correct?
` A Not as a clinician in any way, but subject
` to my last answer.
` Q Oh, has a court qualified you subject to
` something in one of those areas?
` A I have been qualified as an expert in
` pharmaceutical economics on a number of occasions,
` and I think that part of the testimony that I've
` provided deals with the question of the economic
` implications of alleged clinical benefits of
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`Ivan T. Hofmann - May 4, 2016
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` products on prescription pharmaceutical products on
` a regular basis.
` Q Just to be clear, you have never been
` qualified by any court or by the U.S. Patent and
` Trademark Office as an expert in any clinical
` benefits of pharmaceutical products; correct?
` MS. LENTZ: Objection; asked and answered.
` THE WITNESS: I think I've tried to be
` complete in my answer. Not as a clinician, I agree,
` but I've certainly been qualified as an expert in
` pharmaceutical economics, and I've been -- given
` testimony on allegations and suggestions regarding
` the clinical benefits of products and the role that
` they play relative to patents and the role that they
` play relative to claims of commercial success and
` nexus on a regular basis.
` MR. HASFORD: At this point I'm going to
` state an objection for the record. I'm going to
` move to strike the testimony as nonresponsive, and
` we're going to have an objection to Mr. Hofmann's
` testimony in its entirety. He's being nonresponsive
` to these questions. He's already been impeached.
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`Ivan T. Hofmann - May 4, 2016
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` So we're stating that objection for the record.
` BY MR. HASFORD:
` Q Let's go back to your CV, sir, page 88 of
` Exhibit 1122.
` A Okay.
` Q Let's talk about your work at Deloitte &
` Touche. While at Deloitte & Touche, did you ever do
` work for Adelphia Communications?
` A Yes. I was one of many auditors involved
` on that audit.
` Q What did you do for Adelphia
` Communications?
` A At various times, I was a staff auditor
` through, I think, a manager, doing work on the
` external audit of Adelphia.
` Q What work did you do on the external audit
` of Adelphia?
` A I mean, over the course of my career,
` basic blocking and tackling-type audit work of basic
` areas, analyzing the financial statements of the
` company, working on the various reporting entities,
` et cetera.
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`Ivan T. Hofmann - May 4, 2016
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` Q Why were you analyzing the financial
` statements of Adelphia?
` A Well, they had various reporting
` requirements at subsidiary levels and borrowing
` agreements that required them to report the
` financial performance of the company at various
` subsidiary levels as well as various public company
` levels.
` Q How did you go about conducting your work
` for Adelphia at Deloitte & Touche?
` A Like I said, I was one of about 20 to 25
` auditors that worked on the very large audit. Over
` the course of my career, I was given direction by
` various supervisors to do the work that I did and
` performed the procedures I performed.
` Q What sort of work and procedures were
` those?
` MS. LENTZ: Objection.
` I just want to make sure the witness --
` remind him of any confidentiality.
` MR. HASFORD: Yeah, I don't want you to
` breach any confidentiality.
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`Ivan T. Hofmann - May 4, 2016
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` But I plan to show him a publicly
` available opinion shortly.
` MS. LENTZ: Okay.
` THE WITNESS: Basically, doing the work
` that -- I'm sorry. What was the question?
` BY MR. HASFORD:
` Q Let me re-ask the question, so it's clear.
` What sort of work and procedures did you conduct at
` Deloitte & Touche in connection with your work for
` Adelphia?
` A Yeah. So at the direction of various
` managers, senior managers, and partners, I basically
` did work on the audits of various reporting entities
` of various financial statements of the companies.
` Q How did you conduct those?
` A According to the procedures that Deloitte
` had for conducting financial statement audits.
` Q What were those procedures?
` A I mean, they had various model audit
` programs and checklists and guidelines on how to
` conduct audits, and those were what I followed.
` Q What do you mean by "various model audit
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`Ivan T. Hofmann - May 4, 2016
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` programs," "checklists, and guidelines"?
` A Basically, there was guidance on how to
` conduct an audit, and that's what I followed.
` Q What was that guidance?
` A I think that Deloitte had their own
` proprietary guidance that was directed by the
` generally accepted auditing standards that guide
` conducting audits.
` Q What was that guidance?
` A What do you mean, what was that guidance?
` Q You just testified "Deloitte had their
` own" "guidance that was directed by the generally
` accepted auditing standards that guide conducting
` audits."
` Do you remember that?
` A Yeah.
` Q Okay. What was that guidance?
` A Generally accepted auditing standards.
` Q What do you mean by "generally accepted
` auditing standards"?
` A I think that the AICPA provides some
` guidance on how to conduct audits, and I think the
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`Ivan T. Hofmann - May 4, 2016
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` Deloitte tools basically follow the guidance on how
` to conduct audits.
` MR. HASFORD: For the record, I'm handing
` Mr. Hofmann and Petitioner's counsel copies of
` Exhibit 2335. Exhibit 2335 is an opinion from the
` Securities and Exchange Commission in the matter of
` Gregory M. Dearlove, CPA, Administrative Procedure
` File Number 3-12064, Accounting and Auditing
` Enforcement, dated January 31st, 2008.
` (Exhibit 2335 marked for identification.)
` BY MR. HASFORD:
` Q Who is Gregory Dearlove?
` A He was the lead audit partner for the
` Adelphia audits in the year 2000.
` Q Did you work with Mr. Dearlove on the
` Adelphia audits?
` A I worked for Mr. Dearlove.
` Q What was the nature of your work for
` Mr. Dearlove on the Adelphia audits?
` A Like I said, he was the lead partner, and
` I was a manager among 20 to 25 other members of the
` team who were doing work on the Adelphia audits.
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` Q Did you work directly with Mr. Dearlove on
` the Adelphia audits?
` A I probably worked more directly with
` Mr. Caswell, who was a director who reported to
` Mr. Dearlove. But sure, I had interactions with
` Mr. Dearlove.
` Q What were the nature of your interactions
` with Mr. Dearlove on the Adelphia audit?
` A I'm not sure what falls under any
` confidentiality agreement based on my former
` employment, but, you know, the basic types of work
` that one does in conducting an audit and dealing
` with the lead audit partner and the reporting of
` findings of the audit.
` Q Let's take a look at page 1 of Exhibit
` 2335 under "Introduction." It states "Gregory M.
` Dearlove" is certified -- let me try that again.
` It states "Gregory M. Dearlove, a
` certified public accountant and formerly a partner
` with the accounting firm Deloitte & Touche
` ('Deloitte'), appeals from the decision of an
` administrative law judge. The law judge found that
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` De