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` IVAN HOFMANN
` UNITED STATES PATENT AND TRADEMARK OFFICE
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`COALITION FOR AFFORDABLE ) Case: IPR2015-00990 and
`DRUGS II, LLC, ) IPR2015-01093
` Petitioner, )
` - against - ) Patent: 7,056,886
`NPS PHARMACEUTICALS, INC., )
` Patent Owner. )
`-------------------------- )
`
` VIDEOTAPED DEPOSITION OF IVAN HOFMANN
` Atlanta, Georgia
` Friday, May 6, 2016
` 10:21 A.M.
`
` HIGHLY CONFIDENTIAL
`
`Job No: 107129
`Reported by:
`SUZANNE BEASLEY, RPR, CCR-B-1184
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`NPS Ex. 2170
`CFAD v. NPS
`IPR2015-01093
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`Page 1
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` IVAN HOFMANN
` UNITED STATES PATENT AND TRADEMARK OFFICE
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`COALITION FOR AFFORDABLE ) Case: IPR2015-00990 and
`DRUGS II, LLC, ) IPR2015-01093
` Petitioner, )
` - against - ) Patent: 7,056,886
`NPS PHARMACEUTICALS, INC., )
` Patent Owner. )
`-------------------------- )
`
` VIDEOTAPED DEPOSITION OF IVAN HOFMANN
` Atlanta, Georgia
` Friday, May 6, 2016
` 10:21 A.M.
`
` HIGHLY CONFIDENTIAL
`
`Job No: 107129
`Reported by:
`SUZANNE BEASLEY, RPR, CCR-B-1184
`
`TSG Reporting - Worldwide (877) 702-9580
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`NPS Ex. 2170
`CFAD v. NPS
`IPR2015-01093
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`HIGHLY CONFIDENTIAL
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`Page 2
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` IVAN HOFMANN
` INDEX TO EXAMINATION
`
`Examination Page No.
`
` By Mr. Robinson ....................... 8
` By Mr. Blake .......................... 270
` By Mr. Robinson ....................... 292
`
` INDEX TO EXHIBITS
`
`Exhibit No. Page No.
`
`Exhibit 2161 ............................... 17
` List of drugs from Medicare.gov website
` Pharmaceutical Assistance Program
` (Medicare)
`Exhibit 2162 ............................... 24
` List of all drugs approved by the FDA
`
`Exhibit 2163 ............................... 28
` List of orphan drugs approved in the
` United States from 1983 to 2016
`
`Exhibit 2164 ............................... 30
` Medicare formulary
`Exhibit 2165 ............................... 31
` List of drugs with coupons or rebates
` from the website www.rxpharmacycoupons.com
`Exhibit 2166 ............................... 33
` Hofmann declaration and accompanying
` exhibits, consisting of 4 volumes
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`Exhibit 2167 ............................... 104
` Article entitled "Complications of
` Parenteral Nutrition" in Gastroenterology
` Clinics of North America by Ukleja
`Exhibit 2168 ............................... 111
` Printout from rebates.com
`Exhibit 2169 ............................... 124
` Review Article, "The Management of
` Long-Term Parenteral Nutrition," by
` Dibb and others
`Exhibit 2170 ............................... 133
` Excerpt from the Merck Manual, Fifteenth
` Edition
`Exhibit 2171 ............................... 137
` Wikipedia article on Refeeding Syndrome
`Exhibit 2172 ............................... 159
` Petition for Inter Partes Review of
` U.S. Patent No. 7,056,886 (Claims 46-52
` and 61-75)
`Exhibit 2173 ............................... 171
` Article called "AP Impact: Big Pharma
` Cashes in on HGH abuse"
`Exhibit 2174 ............................... 189
` Memorandum opinion from Intendis GmBH,
` et al. versus Glenmark Pharmaceuticals
` Ltd., et al.
`Exhibit 2175 ............................... 192
` Article entitled "Treatment Options for
` Acne Rosacea"
`Exhibit 2176 ............................... 201
` Drugs.com,printout, "Pharmaceutical
` Sales 2010, Top 200 Drugs for 2010 by
` Sales"
`Exhibit 2177 ............................... 201
` Actos label
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`Exhibit 2178 ............................... 201
` Drugs.com printout, "Pharmaceutical
` Sales 2010, Top 200 Drugs for 2010 by
` Units Sold"
`Exhibit 2179 ............................... 203
` National Diabetes Fact Sheet, 2011
`Exhibit 2180 ............................... 206
` Januvia label
`Exhibit 2181 ............................... 208
` Lexapro label
`Exhibit 2182 ............................... 209
` NIH mental health website printout
` Entitled "Major Depression Among Adults
`Exhibit 2183 ............................... 210
` National Institute of Mental Health
` website, Major Depression Among
` Adolescents
`Exhibit 2184 ............................... 211
` Anxiety and Depression Association of
` America website printout on GAD
`Exhibit 2185 ............................... 213
` Novolog label
`Exhibit 2186 ............................... 215
` Orphan Drug Report 2014
`Exhibit 2187 ............................... 216
` Advate label
`Exhibit 2188 ............................... 217
` Fast Facts sheet from hemophilia.org
`Exhibit 2189 ............................... 220
` Revlimid label
`Exhibit 2190 ............................... 221
` National Cancer Institute Surveillance,
` Epidemiology and End Results Program
` SEER Stat Fact Sheet: Myeloma
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`Exhibit 2191 ............................... 222
` Article from the American Journal of
` Medicine entitled "Epidemiology of
` Myelodysplastic Syndromes
`Exhibit 2192 ............................... 223
` Article from Clinical Cancer Research
` entitled "Biological and Prognostic
` Significance of Chromosome 5q Deletions
` in Myeloid Malignancies"
`Exhibit 2193 ............................... 225
` Article entitled "Racial Differences in
` Mantle Cell Lymphoma in the United States"
`Exhibit 2194 ............................... 227
` Velcade label
`Exhibit 2195 ............................... 240
` McKinsey report entitled Insights into
` Pharmaceuticals and Medical Products
`Exhibit 2196 ............................... 242
` Graph of NPS's stock price from 1/1/13
` 5/1/13
`Exhibit 2197 ............................... 247
` Hofmann's Original Graph, Monthly
` Adjusted Close Stock Price
`Exhibit 2198 ............................... 251
` Hofmann's Graph with Correction, Index
` of Monthly Adjusted Close Stock Price
` (Normalizing all prices to 1.0 in
` October 2012)
`Exhibit 2199 ............................... 254
` Hofmann's Graph with Correction, Extended
` Back to 2007, Index of Monthly Adjusted
` Close Stock Price (Taken back to 2007 and
` normalizing all prices to 1.0 in January
` 2007)
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` IVAN HOFMANN
`
` Deposition of IVAN HOFMANN, taken
`on behalf of the Patent Owner, pursuant to
`the stipulations agreed to herein, before
`Suzanne Beasley, Registered Professional
`Reporter and Notary Public, at 191 Peachtree
`Street, Northeast, Suite 3800, Atlanta,
`Georgia, on the 6th day of May, 2016,
`commencing at the hour of 10:21 a.m.
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` IVAN HOFMANN
`APPEARANCES OF COUNSEL:
` On behalf of the Petitioner:
` JEFFREY BLAKE, Esq.
` Merchant & Gould
` 191 Peachtree Street, N.E.
` Atlanta, Georgia 30303
`
` On behalf of the Patent Owner:
` JOSEPH ROBINSON, Esq.
` HEATHER ETTINGER, Esq., Ph.D.
` Troutman Sanders
` 875 Third Avenue
` New York, New York 10022
`
`Videographer: Deidre Thomas
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` IVAN HOFMANN
` THE VIDEOGRAPHER: We are now on the
` record, and the time is approximately
` 10:21 a.m. This is the beginning of disc
` one for the video deposition of Dr. Ivan
` [sic] Hofmann.
` Will counsel please introduce
` themselves and whom they represent, after
` which the court reporter will swear in the
` witness.
` MR. ROBINSON: Joseph Robinson and
` Heather Ettinger representing NPS
` Pharmaceuticals.
` MR. BLAKE: Jeffrey Blake of the firm
` Merchant Gould on behalf of the petitioner,
` Coalition for Affordable Drugs.
` IVAN HOFMANN,
`having been duly sworn, was examined and testified
`as follows:
` EXAMINATION
`BY MR. ROBINSON:
` Q. Good morning, Mr. Hofmann.
` A. Good morning, Mr. Robinson.
` Q. I assume that you've been deposed several
`times, so you know the rules?
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` A. I do.
` Q. Okay. I won't go through them.
` MR. ROBINSON: I'd like to mark this
` transcript confidential, highly
` confidential actually under the protective
` order.
`BY MR. ROBINSON:
` Q. The highest academic degree you hold is a
`bachelor's degree, correct?
` A. I have a bachelor's degree and then I've
`also obtained continuing education since my
`bachelor's degree, but in terms of formal education,
`that's correct.
` Q. I didn't get your name and address. Let's
`start with that.
` A. Sure. My name Ivan Hofmann, and I live at
`169 South Ridge Drive, Cranberry Township,
`Pennsylvania 16066.
` Q. So you don't have a master's degree,
`correct?
` A. No, sir.
` Q. You don't have a Ph.D., correct?
` A. No, sir.
` Q. You don't hold any university positions,
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`do you?
` A. I don't.
` Q. What is Gleason?
` A. Gleason is a specialized consulting firm
`that focuses on helping clients in the areas of
`economics, finance, and accounting.
` Q. What's Gleason's intellectual property
`practice?
` A. So I lead the intellectual property
`practice, and what we do is we help clients both in a
`dispute setting such as this, as well as outside a
`dispute setting, in looking at the economics,
`finance, and accounting issues associated with
`intellectual property.
` That could include monetizing intellectual
`property, licensing intellectual property, valuing
`intellectual property. And then in the context of a
`dispute setting, looking at economic issues with
`respect to quantifying damages, looking at questions
`of irreparable harm, looking at economic issues such
`as secondary considerations of non-obviousness, such
`as this case, et cetera.
` Q. Okay. And I think that as one of your
`qualifications for testifying, you wrote in your
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`declaration that you're a member of LES; is that
`correct?
` A. That's correct.
` Q. What's involved in becoming a member of
`LES?
` A. So to become a member of the Licensing
`Executive Society, one has to have demonstrated
`knowledge and experience with respect to licensing of
`intellectual property. The primary criteria is that,
`you know, one has experience, knowledge, and
`expertise in the area. Of course you have to pay
`dues.
` But in particular, I've also obtained the
`certification of certified licensing professional,
`which is a certification that is granted by the LES,
`which requires a more robust demonstration of
`knowledge, experience, as well as taking a test to
`demonstrate such knowledge and experience.
` Q. Are you sure that to become a member of
`LES you need to demonstrate knowledge and experience?
`I'm a member of LES. All I do is pay my dues.
` A. Yeah. I do agree with you. I think the
`primary thing they're focused on is getting the dues.
`Like I said, though, and maybe I'm blurring the
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`lines, because when I think of LES and my
`involvement, I think of my certification as a
`certified licensing professional. And that certainly
`required a number of years of knowledge and
`experience, as well as taking a test to demonstrate
`my knowledge and experience with respect to licensing
`of intellectual property.
` Q. How many times have you testified at trial
`or deposition about any secondary indicia of
`obviousness?
` MR. BLAKE: Objection to form.
` Compound question.
` THE WITNESS: Specifically with
` respect to secondary indicia of
` non-obviousness, at deposition and trial
` probably 30 to 40 times.
`BY MR. ROBINSON:
` Q. Where have you testified with respect to
`secondary indicia of obviousness?
` A. I would say the primary venues have been
`district court litigation, PTAB matters such as this,
`United States International Trade Commission. I
`think for secondary indicia, that's it. I've
`obviously testified in state court and arbitration
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`matters, but that wouldn't be on patent issues.
` Q. In how many IPRs have you testified
`concerning secondary indicia of obviousness?
` A. That have matured into testimony, I would
`say more than a half dozen.
` Q. In how many IPRs have you submitted
`declarations concerning secondary indicia of
`obviousness?
` A. I haven't tallied it up, but I would say
`somewhere around the order of maybe ten.
` Q. In those ten IPRs in which you've
`submitted declarations concerning secondary indicia
`of obviousness, did you -- how many did you represent
`the petitioner in?
` A. I think the majority have involved the
`petitioner. I'll leave it at that.
` Q. Okay. Does that mean six?
` A. I'd have to go back and look through my
`26A2 to get an accurate count.
` Q. Do you recall any IPRs in which you have
`represented the patent owner?
` A. Yes.
` Q. Which?
` A. In particular, the matter involving Merck
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`Eprova, which is a subsidiary of Merck KGaA, a brand
`new pharmaceutical company. I know I did work on
`behalf of the petitioner. Or I'm sorry, not the
`petitioner, the respondent. Like I said, I'd have to
`go back and look at my 26A2, but that one comes to
`mind.
` Q. Do you recall any other IPRs in which you
`represented the patent owner?
` A. Like I said, I'd have to go back and look
`through my 26A2, but that's the one that comes to
`mind.
` Q. Do you know the outcome of any of the IPRs
`in which you've testified -- I'm sorry, in which
`you've submitted a declaration about secondary
`indicia of obviousness?
` A. Most of them have settled.
` Q. Have been there any decisions by the PTAB,
`final decisions by the PTAB in any of the IPRs in
`which you've submitted a declaration concerning
`secondary indicia of non-obviousness?
` A. I don't know. Kind of once I -- once I
`subject myself to deposition, I don't really follow
`the outcome.
` Q. How many drugs were approved by the FDA in
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`the last five years?
` A. I don't have a tally.
` Q. You think more than a hundred?
` A. Sure.
` Q. Okay. All of the drugs that were approved
`by the FDA in the last five years were the object of
`marketing activities by the marketing company that
`launched the drug, correct?
` MR. BLAKE: Objection to form. Calls
` for speculation.
` THE WITNESS: I can't speak to each
` and every drug that has been approved by
` the FDA in the last several years one way
` or the other.
`BY MR. ROBINSON:
` Q. Do you believe that a majority of the
`drugs that have been approved by the FDA in the last
`five years have been the object of marketing
`activities by the marketing company that launched the
`drug?
` MR. BLAKE: Same objection.
` THE WITNESS: I mean, I'll agree with
` you it's not atypical for the sponsor of an
` application and a launch of a commercial
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` product to put some marketing effort behind
` a drug. Of course that can vary by degree,
` and that can vary based on the facts and
` circumstances.
`BY MR. ROBINSON:
` Q. Okay. If drug marketing prevented a drug
`from being a commercial success, then none of the
`drugs that have been marketed would be commercial
`successes, correct?
` MR. BLAKE: Objection to form. Calls
` for speculation.
` THE WITNESS: I don't understand your
` question.
`BY MR. ROBINSON:
` Q. Okay. Let's say that 50 drugs in the last
`five years have been approved by the FDA and
`marketed, and been the object of marketing
`activities. Okay?
` A. You want me to just assume that?
` Q. Assume that.
` A. Okay.
` Q. If the marketing of those drugs prevented
`the drug from being a commercial success, then none
`of them would be a commercial success, right?
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` MR. BLAKE: Objection.
` THE WITNESS: I still don't
` understand the question, the presupposition
` and assumptions that are embedded therein.
` MR. ROBINSON: Okay. I'll give you a
` list from the Medicare.gov website I'm
` going to mark as deposition Exhibit 2161.
` (Exhibit 2161 was marked for
` identification.)
`BY MR. ROBINSON:
` Q. If you wouldn't mind taking a look at
`that. And on the top of this Exhibit 2161, it says,
`"Pharmaceutical Assistance Program (Medicare),"
`correct?
` A. They're abbreviations that appear on top.
`I can take your representation as to what those
`representations mean.
` Q. These are drugs that have pharmaceutical
`assistance programs in the Medicare formulary. How
`many drugs on the patient Medicare formulary offer
`patient assistance today based upon Exhibit 2161?
` A. I haven't seen Exhibit 2161 before. I
`really can't comment on it.
` Q. You can't tell me how many drugs are on
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` IVAN HOFMANN
`this list? Is that what you're saying?
` MR. BLAKE: You just want him to
` count the number?
` MR. ROBINSON: That's fine with me.
` THE WITNESS: Okay.
` I'm sorry, what was the question?
`BY MR. ROBINSON:
` Q. How many drugs offer a patient assistance
`program today in the Medicare formulary of
`Exhibit 2161?
` A. Like I said, I haven't seen 2161 before.
`Just based on the numbers, I counted 46 drugs on the
`first sheet. It looks like there's 15 pages, which
`mathematically would be just shy of 750.
` Q. Okay. Let's take a look at the first
`drug, Abelcet. If the Abelcet patient assistance
`program prevented Abelcet from being a commercial
`success -- strike that.
` If patient assistance programs prevented a
`drug on this list from being a commercial success,
`then none of the drugs on this list would be a
`commercial success, the list of 2161, correct?
` A. I still don't understand your question --
` Q. Okay.
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` A. -- and however you -- I don't understand
`your question.
` Q. Part of your testimony is that a patient
`assistance program mitigates against the commercial
`success of Gattex, correct?
` A. I don't know that that quite characterizes
`my opinions accurately. I think my opinions are
`outlined in my declaration.
` Q. What's your opinion concerning the patient
`assistance program for Gattex with respect to
`commercial success of Gattex?
` A. So my opinions are in response to the
`claims by Dr. Rausser and are outlined in my
`declaration.
` In particular, Dr. Rausser makes claims
`that the price of Gattex is high, which suggests that
`there's coalescence around the product Gattex. Still
`doesn't tie it to the '886 patent, but that's one of
`his claims.
` One of my response points is that, well,
`there's a great deal of patient insulation that
`occurs where through various tools and schemes
`undertaken by NPS and Shire, a patient is insulated
`from the true cost of Gattex. And so my opinion is
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` IVAN HOFMANN
`that the existence of the patient assistance programs
`and the significance of the patient assistance
`programs with respect to Gattex undermines the claims
`that Dr. Rausser makes with respect to the pricing
`and alleged commercial success of Gattex.
` Q. And how does the patient assistance
`program with respect to Gattex undermine the claims
`that Dr. Rausser makes with respect to the commercial
`success of Gattex?
` A. I think my opinions are outlined and laid
`out in my report, and I would be happy to, you know,
`walk through those in detail if the declaration was
`in front of me.
` But at a high level, basically, you know,
`NPS has made many public statements and has many
`public documents that talk about the ways in which
`they work hard through their concierge programs, the
`OnePath program and other programs, legacy programs
`that insulate patients from essentially feeling the
`true cost of Gattex.
` And so any claims that Dr. Rausser makes
`with respect to the high price of Gattex, any claims
`that Dr. Rausser makes in terms of the alleged
`commercial success are undermined by the fact that,
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` IVAN HOFMANN
`you know, NPS and Shire have gone to great, great
`lengths to insulate patients from the true cost of
`the product, all of which are extrinsic factors
`unrelated to the claims of the patent at issue.
` Q. What's the cost of Gattex annually for one
`patient?
` A. I think according to the Rausser
`declaration, when it launched it was on the order of
`$300,000 from a WAC perspective, and that has risen
`to north of $400,000 again on a WAC perspective, but
`for the patient, I think the aim of NPS/Shire has
`been to limit the out-of-pocket cost to zero to $300
`a month for the patient.
` Q. So that would leave somewhere between
`$399,700 and 400,000 that needs to be paid by
`someone, correct?
` A. When you say "paid by someone," not
`necessarily. Certainly third-party payers bear the
`brunt of that cost, but I think NPS and Shire have
`also absorbed a great deal of that cost with respect
`to certain patients.
` Q. How much of that cost has NPS and Shire
`absorbed with respect to certain patients?
` A. I don't know that I would quantitate a
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` IVAN HOFMANN
`hard figure on that.
` Q. And for how many patients has Shire
`absorbed a great deal of that cost?
` A. I think that all patients have some level
`of sharing because all patients are subject to some
`level of discounting, rebates, and other gross and
`net adjustments that would be part of what Shire/NPS
`absorbs with respect to patients.
` Q. And how much of a discount does Shire give
`on Gattex?
` A. I think it varies over time.
` Q. Okay. Would it be ten percent?
` A. I think that's about right. Somewhere on
`the order of that range.
` Q. And how much of a rebate does Shire give
`on Gattex?
` A. I think the amount you indicated.
`Somewhere on the order of around ten percent, from
`what I remember from the documents, is inclusive of
`discounts, rebates, et cetera.
` Q. Okay. So if we're looking at 400,000 and
`we discount it ten percent, that would be 360,000,
`correct?
` A. Yes, sir.
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` IVAN HOFMANN
` Q. And if we now deduct the zero to $300 that
`a patient would pay out-of-pocket, that would leave
`us with $359,900 -- $359,300 to $360,000, right?
` MR. BLAKE: Objection.
` THE WITNESS: I don't think your math
` is quite right.
`BY MR. ROBINSON:
` Q. Probably not. If we deduct the zero to
`$300 that a patient would pay out-of-pocket, that
`would leave us with 359,700 through 360,000, correct?
` A. That I think is the bath. Again,
`recognizing, as I explained in my declaration, that
`there are very few patients on this product, and to
`any one formulary, there's only a handful of patients
`on the product, but I think your math is correct.
` Q. But the formulary would be paying
`somewhere between 359,300 to 360,000 annually,
`correct?
` A. I think seven hundred. 359 --
` Q. 359,700, you're right. So the formulary
`would be paying 359,700 to $360,000 a year, correct?
` A. In generalities, yes, for the very limited
`patient population that is on this.
` MR. ROBINSON: I'll show you what
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` we're going to mark as Exhibit 2162.
` (Exhibit 2162 was marked for
` identification.)
`BY MR. ROBINSON:
` Q. I'll represent to you that Exhibit 2162 is
`a list of all drugs approved by the FDA.
` A. All right. I'll take your representation.
`I'll also say that I'm due for an eye appointment,
`and I'll do my best to read the very small typeset
`that is contained herein.
` Q. You would agree that there are over a
`thousand drugs approved by the FDA; is that correct?
` MR. BLAKE: Objection to form.
` THE WITNESS: I mean, I'm unfamiliar
` with the document you've just put in front
` of me, but I certainly wouldn't object to
` that characterization that there are at
` least a thousand approved drugs by the FDA.
`BY MR. ROBINSON:
` Q. And you would agree that a majority of the
`drugs approved by the FDA when they're approved have
`exclusivity, some sort of exclusivity, patent or data
`exclusivity, correct?
` MR. BLAKE: Objection to form. Calls
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` IVAN HOFMANN
` for speculation.
` THE WITNESS: I don't know that I can
` agree with that. I think that many drugs,
` any exclusivity has lapsed, and I haven't
` really done a tally to figure out how many
` have exclusivities versus those that have
` had such exclusivity lapse.
`BY MR. ROBINSON:
` Q. That wasn't my question, though.
` I said you'd agree that of the drugs
`approved by the FDA, when they're approved they have
`some sort of data or patent exclusivity, correct?
` MR. BLAKE: Objection to form. Calls
` for speculation.
` THE WITNESS: Did you say data?
`BY MR. ROBINSON:
` Q. Yeah, data exclusivity. For example, NCE
`exclusivity, formulation exclusivity, method of use
`exclusivity.
` A. Yeah. I mean, I don't know that the
`majority have NCE exclusivity. Certainly if they're
`an NCE, they do. Many drugs do have other
`exclusivities, be they ODE or method of use for
`particular indications, but I think it's facts and
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` IVAN HOFMANN
`circumstances based.
` Q. Okay. And patent or data exclusivity does
`not prevent a drug from being a commercial success,
`does it?
` MR. BLAKE: Objection to form.
` THE WITNESS: I don't understand the
` question.
`BY MR. ROBINSON:
` Q. You don't know what patent exclusivity is?
` A. Sure.
` Q. What is it?
` A. You know, if one has a patent, a patent
`provides a certain amount of exclusivity. Patent
`holders self-report through the Orange Book patents
`which cover their particular products. That can
`deter and prevent others from launching products.
`But, you know, there's mechanisms under the
`Hatch-Waxman Act and others where one can challenge
`the validity of such patents.
` Q. Do you know what data exclusivity is?
` A. I think data exclusivity would fall more
`in the line of if you get approval for a particular
`indication for which product has not previously been
`approved where you've undertaken clinical trials to
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` IVAN HOFMANN
`satisfy the requirements to get approval, you know,
`one can get generally three years of exclusivity with
`respect to a particular indication.
` Q. Does patent exclusivity preclude
`commercial success?
` A. What was the question again?
` Q. Does patent exclusivity preclude
`commercial success of a drug?
` A. Okay. So I mean, commercial success as a
`term of art in an obviousness inquiry has certain
`meanings. And I think that in certain circumstances,
`yes, the existence of, for example, a compound patent
`which serves to block others from pursuing a
`particular compound -- and I think there's caselaw on
`this, not as a lawyer, but in terms of Merck v. Teva,
`I think it's well-settled caselaw that such a
`situation can prevent the objectivity of the
`commercial performance of the product from providing
`commercial success as a term of art in an obviousness
`inquiry.
` Q. And there are certain circumstances in
`which patent exclusivity does not preclude commercial
`success, correct?
` A. Depending on the facts and circumstances,
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` IVAN HOFMANN
`that can be the case.
` Q. And there are certain circumstances under
`which data exclusivity does not preclude commercial
`success, correct?
` A. I think with each of these, one would need
`to look at the specific facts and circumstances, but
`I don't quarrel that as a generality, it depends on
`the facts and circumstances.
` MR. ROBINSON: I'll show you what
` we're going to mark as Exhibit 2163.
` (Exhibit 2163 was marked for
` identification.)
`BY MR. ROBINSON:
` Q. I'll represent to you that 2163 is a list
`of orphan drugs approved in the United States from
`1983 to 2016. Do you know what orphan drug
`exclusivity is?
` A. I do.
` Q. What is it?
` A. Under the Orphan Drug Act of 1983, certain
`drugs can apply for and obtain seven years of
`exclusivity. The criteria for I think being an
`orphan drug is that there's a patient population or a
`poten
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