Transcript of the Testimony of Joel Hay, Ph.D.
`
`Date: October 21, 2019
`
`Case: Mylan Pharmaceuticals Inc. v. Biogen MA, Inc.
`
`Ace-Federal Reporters, Inc.
`Phone: 202-347-3700
`Fax: 202-737-3638
`Email: info@acefederal.com
`Internet: www.acefederal.com
`
`Biogen Exhibit 2230
`Mylan v. Biogen
`IPR 2018-01403
`
`Page 1 of 250
`
`
`
`Date: October 21, 2019
`
`Case: Mylan Pharmaceuticals Inc. v. Biogen MA, Inc.
`
`Ace-Federal Reporters, Inc.
`Phone: 202-347-3700
`Fax: 202-737-3638
`Email: info@acefederal.com
`Internet: www.acefederal.com
`
`Biogen Exhibit 2230
`Mylan v. Biogen
`IPR 2018-01403
`
`Page 1 of 250
`
`
`
`Joel Hay, Ph.D.
`
`Mylan Pharmaceuticals Inc. v. Biogen MA, Inc.
`
`October 21, 2019
`
` UNITED STATES PATENT AND TRADEMARK OFFICE
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`Page 1
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`MYLAN PHARMACEUTICALS INC., )
` PETITIONER, ) CASE NO.
` vs. ) IPR2018-01403
`BIOGEN MA, INC., )
` PATENT OWNER. )
`____________________________)
`
` VIDEOTAPED DEPOSITION OF JOEL HAY, PHD, TAKEN
`ON BEHALF OF THE PATENT OWNER, AT 8:09 A.M., MONDAY,
`OCTOBER 21, 2019, AT 1888 CENTURY PARK EAST,
`LOS ANGELES, CALIFORNIA, BEFORE AUDRA E. CRAMER,
`CSR NO. 9901, PURSUANT TO NOTICE.
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`Joel Hay, Ph.D.
`
`Mylan Pharmaceuticals Inc. v. Biogen MA, Inc.
`
`October 21, 2019
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`Page 2
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`APPEARANCES OF COUNSEL
`
`FOR PETITIONER MYLAN PHARMACEUTICALS, INC.:
` PERKINS COIE LLP
` BY: MICHAEL A. CHAJON, ESQUIRE
` 700 13TH STREET, NW, SUITE 600
` WASHINGTON, DC 20005
` (202) 654-6200
` mchajon@perkinscoie.com
`
`FOR PETITIONER SAWAI:
` KATTEN MUCHIN ROSENMAN LLP
` BY: MARTIN S. MASAR III, ESQUIRE
` 525 WEST MONROE STREET
` CHICAGO, ILLINOIS 60661
` (312) 902-5200
` martin.masar@katten.com
`
`FOR PATENT OWNER BIOGEN MA:
` FINNEGAN, HENDERSON, FARABOW,
` GARRETT & DUNNER LLP
` BY: MARK J. FELDSTEIN, ESQUIRE
` PIER D. DeROO, ESQUIRE
` 901 NEW YORK AVENUE, NW
` WASHINGTON, DC 20001
` (202) 408-4000
` mark.feldstein@finnegan.com
` pier.deroo@finnegan.com
`
`ALSO PRESENT:
` ALAN HERNANDEZ, VIDEOGRAPHER
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`Joel Hay, Ph.D.
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`Mylan Pharmaceuticals Inc. v. Biogen MA, Inc.
`
`October 21, 2019
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`Page 3
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` I N D E X
`WITNESS
`JOEL HAY
`
`EXAMINATION PAGE
`BY MR. FELDSTEIN 7
`(P.M. SESSION) 173
`BY MR. CHAJON 192
`BY MR. FELDSTEIN 199
`
` E X H I B I T S
`NO. PAGE DESCRIPTION
`Exhibit 2206 45 ARTICLE ENTITLED "GOOD
` RESEARCH PRACTICES FOR
` MEASURING DRUG COSTS IN
` COST-EFFECTIVENESS
` ANALYSES"
`Exhibit 2207 51 ARTICLE ENTITLED
` "COST-EFFECTIVENESS
` ANALYSIS OF RIZATRIPTAN AND
` SUMATRIPTAN VERSUS CAFERGOT
` IN THE ACUTE TREATMENT OF
` MIGRAINE"
`
`Exhibit 2208 57 CNS DRUGS ARTICLE, VOLUME
` 29, NO. 1
`Exhibit 2209 89 DECLARATION OF PROFESSOR
` JOEL W. HAY
`
`Exhibit 2210 99 COGNOS STUDY #9 ENTITLED
` "MULTIPLE SCLEROSIS 2005 TO
` 2020"
`
`Exhibit 2211 114 DEPOSITION OF JOEL HAY
` TAKEN 6/24/15
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`Joel Hay, Ph.D.
`
`Mylan Pharmaceuticals Inc. v. Biogen MA, Inc.
`
`October 21, 2019
`
`Page 4
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`EXHIBITS (CONTINUED)
`NO. PAGE DESCRIPTION
`Exhibit 2212 124 DECLARATION OF PROFESSOR
` JOEL W. HAY, CASE NO.
` IPR2015-00643
`Exhibit 2213 156 GILENYA FACEBOOK PAGE
`Exhibit 2214 158 AUBAGIO FACEBOOK PAGE
`Exhibit 2215 160 GILENYA PATIENT SERVICES
` LIAISON PAGE
`
`Exhibit 2216 161 GILENYA (FINGOLIMOD) MS
` EVENTS PAGE
`Exhibit 2217 186 ARTICLE ENTITLED
` "COMPETITION, MARKET POWER
` AND PRICING IN BRAND-NAME
` PHARMACEUTICAL MARKETS" BY
` JOEL HAY
`Exhibit 1150 194 HANDWRITTEN
` WITNESS-CORRECTED
` MS THERAPIES ESTIMATED US
` SALES Q1 2009 THROUGH Q4
` 2018
`
` QUESTIONS INSTRUCTED BY COUNSEL NOT TO ANSWER
` PAGE LINE
` 199 9
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`Joel Hay, Ph.D.
`
`Mylan Pharmaceuticals Inc. v. Biogen MA, Inc.
`
`October 21, 2019
`
` LOS ANGELES, CALIFORNIA;
` MONDAY, OCTOBER 21, 2019, 8:09 A.M.
`
`Page 5
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` THE VIDEOGRAPHER: We are on record.
`Please note that the microphones are sensitive
`and may pick up whispering and private
`conversations. The recording will continue
`until both parties agree to go off the record.
` This is the deposition of Joel Hay in
`the matter of Mylan Pharmaceuticals, Inc. Versus
`Biogen MA, Inc. Case number is IPR2018-01403,
`Patent No. 8,399,514, filed in the United States
`Patent and Trademark Office before the Patent
`Trial and Appeal Board.
` The deposition today is being held at
`Perkins Coie LLP, located at 1888 Century Park
`East, Suite 1700, Los Angeles, California 90067.
`The time is 8:10 a.m. Today's date is
`October 21, 2019.
` The court reporter today is Audra
`Cramer with the firm Barkley Court Reporters,
`Inc. I'm the videographer, Alan Hernandez,
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`Joel Hay, Ph.D.
`
`Mylan Pharmaceuticals Inc. v. Biogen MA, Inc.
`
`October 21, 2019
`
`Page 6
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`representing the firm of Ace Federal Reporters
`located at 555 12th Street NW, Washington, DC
`20004.
` Will Counsel present identify
`yourselves and state who you represent for the
`record, please.
` MR. FELDSTEIN: I'm Mark Feldstein from
`Finnegan Henderson on behalf of patent owner
`Biogen. With me is my colleague from Finnegan
`Henderson, Pier DeRoo.
` MR. CHAJON: Michael Chajon from
`Perkins Coie on behalf of Mylan Pharmaceuticals,
`Inc.
` MR. MASAR: Martin Masar from Katten
`Muchin Rosenman on behalf of the Sawai
`petitioners that were joined to this IPR.
` THE VIDEOGRAPHER: Will the court
`reporter please swear in the witness, and we can
`begin.
`
` JOEL HAY,
` having been first duly sworn, was
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`Joel Hay, Ph.D.
`
`Mylan Pharmaceuticals Inc. v. Biogen MA, Inc.
`
`October 21, 2019
`
`Page 7
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` examined and testified as follows:
`
` EXAMINATION
`BY MR. FELDSTEIN:
` Q Good morning, Dr. Hay. How are you?
` A Good. How are you?
` Q Fine thanks.
` Does Dr. Hay need his microphone on for
`the video?
` THE REPORTER: Yes.
`BY MR. FELDSTEIN:
` Q Dr. Hay, I've handed you already your
`expert report, 1120; correct?
` A It appears to be, yes.
` Q Okay. Did you write this report?
` A Yes. I may not have personally written
`every single word, but every word was produced
`under my direction or by me personally, and I'm
`totally comfortable with everything that's in
`here.
` Q And about how much time did you put
`into developing this report?
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`Joel Hay, Ph.D.
`
`Mylan Pharmaceuticals Inc. v. Biogen MA, Inc.
`
`October 21, 2019
`
`Page 8
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` A I don't recall.
` Q You can't estimate?
` A Not really, no.
` Q Was it more than 10 hours?
` A Definitely more than 10 hours.
` Q More than 50 hours?
` A Probably.
` Q More than 100 hours?
` A Maybe.
` Q When was it you started on your report?
` A I don't specifically recall, but my
`guess would be in the past six months.
` Q What was your assignment? Do you
`recall that in preparing your report?
` A As I recall, my assignment was to
`prepare a report or declaration relating to
`issues of commercial success and nonobviousness
`for the '514 patent in my role as a health
`economist and pharmaceutical economist.
` Q Were you asked to independently
`evaluate the multiple sclerosis marketplace?
` A I'm not sure I understand the question.
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`Joel Hay, Ph.D.
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`Mylan Pharmaceuticals Inc. v. Biogen MA, Inc.
`
`October 21, 2019
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`Page 9
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` Q Were you asked to independently
`evaluate the products in the multiple sclerosis
`marketplace?
` MR. CHAJON: Objection form.
` THE WITNESS: I mean, certainly in the
`course of my career as a pharmaceutical
`economist, I've been evaluating the MS drugs for
`decades.
`BY MR. FELDSTEIN:
` Q Sure. But do you understand my
`question was were you asked in this case to
`provide an independent analysis of the MS
`marketplace?
` MR. CHAJON: Objection to form.
` THE WITNESS: Only to the extent that I
`needed to fill out my report, my declaration.
`BY MR. FELDSTEIN:
` Q And did you come to an independent
`opinion on what drugs there are in the MS
`marketplace that Tecfidera competes with?
` MR. CHAJON: Objection to form.
` THE WITNESS: Well, as I say, I haven't
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`Joel Hay, Ph.D.
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`Mylan Pharmaceuticals Inc. v. Biogen MA, Inc.
`
`October 21, 2019
`
`Page 10
`done a comprehensive assessment of all the drugs
`that compete with Tecfidera for the purposes of
`an antitrust, let's say, evaluation, which is
`another thing that health economists and
`pharmaceutical economists might do in this kind
`of a scenario.
` But, like I said, what I did do was
`evaluate the drugs to the extent that I needed
`to for the purpose of the report, and as I say
`in the report, I have some issues with
`Mr. Jarosz's characterization of the drugs in
`the market.
`BY MR. FELDSTEIN:
` Q Sure. But my question, Dr. Hay, is for
`the purposes of your opinion in this case, did
`you come to an independent opinion on what drugs
`there are in the marketplace that compete with
`Tecfidera?
` MR. CHAJON: Objection to form.
` THE WITNESS: I think I just answered
`that.
`BY MR. FELDSTEIN:
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`Joel Hay, Ph.D.
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`Mylan Pharmaceuticals Inc. v. Biogen MA, Inc.
`
`October 21, 2019
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`Page 11
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` Q I don't think you did, actually.
` Do you mind repeating it? Or maybe I
`didn't follow your answer.
` A Can we read back my answer?
` Q No. I think we heard things about
`antitrust.
` I'm trying to understand if you in this
`case were asked to and formed an independent
`opinion on what drugs there are in the
`marketplace that compete with Tecfidera?
` MR. CHAJON: Objection to form.
` THE WITNESS: As I said, to the extent
`I needed to look at that for the purpose of
`writing my declaration, I did, and I found
`serious deficiencies in what Mr. Jarosz claimed
`about the drugs competing against Tecfidera.
`BY MR. FELDSTEIN:
` Q Sure. And do you understand I didn't
`ask you about Mr. Jarosz's report in my
`question?
` A I answered the question, and I added
`what I thought might be helpful.
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`Joel Hay, Ph.D.
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`Mylan Pharmaceuticals Inc. v. Biogen MA, Inc.
`
`October 21, 2019
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`Page 12
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` Q Okay. Did you -- what, if any,
`independent opinion did you come to about what
`drugs compete with Tecfidera in the MS
`marketplace?
` MR. CHAJON: Objection to form.
` THE WITNESS: I came to the opinions
`that are expressed in my report. We can go
`through my report line by line and find them. I
`don't have them -- all of my opinions in active
`memory as we sit here today.
`BY MR. FELDSTEIN:
` Q Sure. You have your report, and I'm
`asking you -- and if you want to consult your
`report -- what, if any independent opinion you
`came to about what drugs compete with Tecfidera
`in the MS marketplace?
` You can look in the report as much as
`you like.
` A Well, I think my paragraph 36 and 37
`speak to that a little bit. I list the drugs
`that are on the MS Society website, 17 DMTs. Of
`course, those aren't the only drugs used to
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`Joel Hay, Ph.D.
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`Mylan Pharmaceuticals Inc. v. Biogen MA, Inc.
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`October 21, 2019
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`Page 13
`treat MS. And as I say in paragraph 37, I agree
`that Tecfidera competes with all available MS
`treatments.
` And there are other things I say in the
`report if you want me to go through it, and we
`can find them.
` Q Sure. Whatever you need to do to
`answer the question of what, if any, independent
`opinion you came to about what drugs compete
`with Tecfidera in the multiple sclerosis
`marketplace.
` So far you've identified the drugs
`listed in paragraph 36 and 37, and you're
`representing those are your independent judgment
`on the drugs that Tecfidera competes with; is
`that correct?
` MR. CHAJON: Objection to form.
` THE WITNESS: No. I said those are
`among the drugs. I said there are others.
`BY MR. FELDSTEIN:
` Q But is your independent opinion that
`Tecfidera competes with at least the drugs in
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`Joel Hay, Ph.D.
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`Mylan Pharmaceuticals Inc. v. Biogen MA, Inc.
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`October 21, 2019
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`Page 14
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`paragraph 36 of your report, Exhibit 1120?
` A Yeah, I think that's fair to say.
` And, as I said, that's not the complete
`list. For example, in paragraph 82 I talk about
`some additional drugs that Mr. Jarosz didn't
`include in his quantitative analysis.
` Q I'm sorry. Aren't all the drugs in
`paragraph 82 also listed in paragraph 36?
` A They may be, but I'm just pointing out
`that he didn't include them in his quantitative
`analysis.
` Q Okay. Do you understand my question,
`Dr. Hay, is your independent opinion, if any, on
`what drugs Tecfidera competes with in the MS
`marketplace?
` MR. CHAJON: Objection to form.
` THE WITNESS: I think I answered that.
`BY MR. FELDSTEIN:
` Q Okay. And so is it the list that's in
`paragraph 36?
` A As I --
` MR. CHAJON: Objection to form.
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`Joel Hay, Ph.D.
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`Mylan Pharmaceuticals Inc. v. Biogen MA, Inc.
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`October 21, 2019
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`Page 15
` THE WITNESS: -- said, it includes the
`ones in paragraph 36. That's not a complete
`list.
`BY MR. FELDSTEIN:
` Q And do you have an opinion on what else
`beyond the list in 36 Tecfidera competes with in
`the MS marketplace?
` A I'll have to go back to 36 and see
`what's there.
` Yeah, I mean, there's all kinds of
`older drugs that are not disease modifying, like
`steroids. There's the drug that's used for
`treating gait disorders in MS patients, which I
`don't think is here.
` There's -- you know, there's all kinds
`of drugs that are used to treat MS that are not
`here.
` Q Okay. And why do you not include them
`in your report?
` A Because they weren't necessary for me
`to do what I needed to do to write my
`declaration.
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`Joel Hay, Ph.D.
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`Mylan Pharmaceuticals Inc. v. Biogen MA, Inc.
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`October 21, 2019
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`Page 16
` Q You didn't need to determine what the
`marketplace was that Tecfidera competes with?
` A Well, my understanding of this cases --
`and I've done quite a few ANDA patent challenge
`cases -- is that the burden is on the plaintiffs
`to show secondary considerations of
`nonobviousness and -- so that determines what I
`believe I have to do.
` You know, I wasn't asked to write
`Mr. Jarosz's report; he was. So my declaration
`is a response to what he did.
` Q Okay.
` A And so for the purposes of what I was
`asked to do, I think I fully characterized what
`I needed to characterize regarding competitive
`treatments in the MS marketplace.
` Q You weren't asked to include in your
`report a full listing of all drugs with which
`Tecfidera competes with in the MS marketplace;
`is that correct?
` MR. CHAJON: Objection to form.
` And just warn the witness to be mindful
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`Joel Hay, Ph.D.
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`October 21, 2019
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`Page 17
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`of any discussions with his attorneys in not
`discussing those.
` THE WITNESS: Yeah, I was asked to look
`at what I needed to look at based on my
`experience as a pharmaceutical economist having,
`I think, a reasonably good understanding of what
`is needed for a pharmaceutical economist expert
`to opine on with respect to issues of commercial
`success and long-felt need as secondary
`considerations of nonobviousness, and so that's
`what I did.
`BY MR. FELDSTEIN:
` Q In your view, it wasn't necessary to
`include a complete and comprehensive listing of
`all the drugs that Tecfidera competes with in
`the MS marketplace; correct?
` MR. CHAJON: Objection to form.
` THE WITNESS: Well, certainly
`Mr. Jarosz didn't include them all; in fact, he
`left out quite a few. But that -- and since my
`report -- my declaration is responding to his,
`to some extent I didn't need to get into all of
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`Joel Hay, Ph.D.
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`Mylan Pharmaceuticals Inc. v. Biogen MA, Inc.
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`October 21, 2019
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`Page 18
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`those issues.
` But having said that, I mean, you know,
`there -- all I really need to show is that --
`what's stated in my report, and we can go
`through my opinions if you want. I didn't need
`to fully characterize every drug that competes
`with Tecfidera in the MS marketplace.
` And a lot of these drugs it'd be hard
`to. I mean, steroids are used for all kinds of
`things. How would -- I mean, you'd have to do
`a, you know, very detailed analysis to get at
`steroids, for example, and it wasn't necessary
`for the purposes of what I was asked to do in
`this report.
`BY MR. FELDSTEIN:
` Q Okay. Were you asked, Dr. Hay, to do
`an independent assessment of what Tecfidera's
`actual sales have been?
` MR. CHAJON: Objection to form. And
`the same warning to the witness.
` THE WITNESS: I mean, I certainly
`looked at sales figures that were provided by
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`Joel Hay, Ph.D.
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`Mylan Pharmaceuticals Inc. v. Biogen MA, Inc.
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`October 21, 2019
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`Page 19
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`Mr. Jarosz.
` MR. FELDSTEIN: Can you read back the
`question, please.
` (Record read as follows:
` "Question: Were you asked,
` Dr. Hay, to do an independent
` assessment of what Tecfidera's
` actual sales have been?")
` MR. CHAJON: Same objections.
` THE WITNESS: Same answer.
`BY MR. FELDSTEIN:
` Q Okay. What is your independent
`assessment, Dr. Hay, if any, of what Tecfidera's
`actual sales have been?
` MR. CHAJON: Objection to form.
` THE WITNESS: Well, in order to do an
`independent -- my own independent assessment of
`what Tecfidera's sales have been, I would phone
`up people at Biogen and ask them, "Tell me what
`are your actual sales. And don't give me gross
`sales. Give me the sales net of all rebates."
`I know as a pharmaceutical economist you have
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`Joel Hay, Ph.D.
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`Mylan Pharmaceuticals Inc. v. Biogen MA, Inc.
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`October 21, 2019
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`Page 20
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`that data. You have that information.
`Mr. Jarosz could have easily asked for it. I
`don't know why he didn't.
` I would have asked them -- if I'd
`written his report, the first thing I would have
`done is I would have contacted Biogen Idec and
`asked them for their actual sales, not the phony
`gross sales which Mr. Jarosz reports here from
`the Symphony data. But they easily have that.
`They have every single rebate check they've ever
`issued. They have every line item, discount,
`rebate, coupon they've ever granted. Why didn't
`they turn it over to him?
` MR. FELDSTEIN: So I'm going to move to
`strike.
` Can you read back the question, please.
` (Record read as follows:
` "Question: What is your
` independent assessment, Dr. Hay,
` if any, of what Tecfidera's
` actual sales have been?")
` MR. CHAJON: For the record, we
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`Joel Hay, Ph.D.
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`Mylan Pharmaceuticals Inc. v. Biogen MA, Inc.
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`October 21, 2019
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`Page 21
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`obviously oppose the motion to strike.
`BY MR. FELDSTEIN:
` Q Can you answer the question, Dr. Hay?
` A I did.
` Q What is your independent assessment, if
`any, of what Tecfidera's actual sales have been,
`Dr. Hay?
` A If I had needed to independently verify
`the actual sales of Tecfidera, I would have
`contacted Biogen or gotten them through
`discovery to turn over their actual sales.
`That's what I would have done.
` Q I'm not asking what you would have
`done. I'm asking what did you do and what did
`you conclude, if anything, on what Tecfidera's
`actual sales has been?
` If you don't have an opinion on what
`Tecfidera's actual sales have been, that's fine.
`I'm trying to find out if you have an opinion on
`your own independent assessment of Tecfidera's
`actual sales.
` MR. CHAJON: Objection --
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`Joel Hay, Ph.D.
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`Mylan Pharmaceuticals Inc. v. Biogen MA, Inc.
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`October 21, 2019
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`Page 22
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`BY MR. FELDSTEIN:
` Q Do you have one, yes or no?
` MR. CHAJON: Objection to form.
` THE WITNESS: Yeah. My opinion is
`they're much lower than what Mr. Jarosz reported
`based on sticker price gross sales from
`Symphony.
`BY MR. FELDSTEIN:
` Q And how much lower than what Mr. Jarosz
`reported?
` A I haven't independently investigated
`that. I'd have to contact Biogen to do it. If
`I'd done that, I know it would be substantially
`greater than 30 percent. It could be much
`greater than that. I really don't know.
` Q Okay.
` A Could be 90 percent discount. I don't
`know.
` Q You don't know? You haven't
`investigated?
` A I wasn't asked to.
` Q Okay. And that's all I'm trying to
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`Joel Hay, Ph.D.
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`Mylan Pharmaceuticals Inc. v. Biogen MA, Inc.
`
`October 21, 2019
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`Page 23
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`find out: What your assignment was and what
`you've done, Dr. Hay.
` In terms of sales data for other drugs
`that compete with Tecfidera in the marketplace,
`do you have your own independent assessment of
`sales data for the drugs that compete with
`Tecfidera?
` MR. CHAJON: Objection to form.
` THE WITNESS: I guess I would answer
`similarly. I would have to find some way to get
`at the discounts and rebates, because all we
`have is Symphony data from a subset of MS drugs.
` So had somebody asked me to do that, I
`would have found a way to calculate rebates and
`discounts for the other drugs, but I wasn't
`asked to do that.
`BY MR. FELDSTEIN:
` Q You weren't asked and you didn't do
`that in your report; correct?
` A That's correct.
` Q Okay. What, if anything, were you
`asked to do in terms of determining whether any
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`Joel Hay, Ph.D.
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`Mylan Pharmaceuticals Inc. v. Biogen MA, Inc.
`
`October 21, 2019
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`Page 24
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`third party was or was not blocked from
`developing a DMF, dimethyl fumarate, product for
`MS based on Biogen's earlier patent on
`microparticles and its pending application?
` MR. CHAJON: Objection to form.
` THE WITNESS: I read some articles and
`saw some testimony that indicated that that is
`the way that would go.
`BY MR. FELDSTEIN:
` Q Did you investigate as a factual matter
`whether there were companies that were pursuing
`DMF products other than Biogen that were blocked
`by Biogen?
` MR. CHAJON: Objection to form.
`Relevance.
` THE WITNESS: Only to the extent that I
`know that none of them did produce any such
`product. So to that extent, factually I know it
`didn't happen.
`BY MR. FELDSTEIN:
` Q Factually you know no one else put a
`DMF product on the market besides Biogen;
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`Joel Hay, Ph.D.
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`Mylan Pharmaceuticals Inc. v. Biogen MA, Inc.
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`October 21, 2019
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`Page 25
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`correct?
` A Correct.
` Q You don't know whether or not others
`developed or attempted to develop a DMF product
`for MS; is that correct also?
` MR. CHAJON: Objection to form.
` THE WITNESS: Well, I mean, all of that
`would be highly confidential in any case, and
`I'm not sure, even if it happened, that I would
`necessarily be able to detect it, because we're
`talking about discovery from multiple companies
`that aren't party to this case, and so it's
`unlikely that they would tell me.
` So I think, you know, based on the fact
`that nothing was launched from any other company
`over the time period, we can say that the
`patents were pretty effective at blocking
`development.
`BY MR. FELDSTEIN:
` Q Okay. But you didn't investigate
`others attempted to develop a DMF product for
`MS; correct?
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`Joel Hay, Ph.D.
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`Mylan Pharmaceuticals Inc. v. Biogen MA, Inc.
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`October 21, 2019
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`Page 26
` A Only to the extent I've just answered.
` Q Only to the extent that no one actually
`put one on the market; correct?
` MR. CHAJON: Objection to form.
` THE WITNESS: Like I say, it's -- even
`if they had been developing it secretly, I
`wouldn't -- I would have no way of necessarily
`knowing that.
`BY MR. FELDSTEIN:
` Q But you didn't even look in public
`records to see whether someone else, some other
`company or companies were developing or
`attempting to develop a DMF product for MS; is
`that correct?
` You weren't asked to do that?
` A No, I wasn't asked to do that. So
`other than what I've just said, I don't really
`have any additional observations on that.
` Q Okay. You weren't asked to investigate
`in the public record whether third parties were
`developing or attempting to develop DMF products
`for MS, and as a factual matter, you didn't do
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`Joel Hay, Ph.D.
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`Mylan Pharmaceuticals Inc. v. Biogen MA, Inc.
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`October 21, 2019
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`Page 27
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`that investigation; correct?
` MR. CHAJON: Objection to form and
`relevance.
` THE WITNESS: No, other than,
`obviously, Mylan at some point was developing an
`alternative.
`BY MR. FELDSTEIN:
` Q Right. And Mylan --
` A I'm aware of that.
` Q Yeah. And how many other generics do
`you know were developing a DMF product?
` MR. CHAJON: Objection to form.
`Relevance.
` THE WITNESS: I am aware that there
`were multiple filers on the first day that the
`ANDA filers could file.
`BY MR. FELDSTEIN:
` Q Do you know roughly how many?
` MR. CHAJON: Objection. Relevance.
` THE WITNESS: Over 20.
`BY MR. FELDSTEIN:
` Q Okay. Do you know how many, if any of
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`Joel Hay, Ph.D.
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`Mylan Pharmaceuticals Inc. v. Biogen MA, Inc.
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`October 21, 2019
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`Page 28
`them, are using microparticle formulations of
`DMF?
` MR. CHAJON: Objection to form.
` THE WITNESS: I don't know that.
`BY MR. FELDSTEIN:
` Q Do you know if any of them are using
`microparticle formulations of DMF?
` MR. CHAJON: Objection. Relevance.
` THE WITNESS: I don't know that.
`BY MR. FELDSTEIN:
` Q One of the things you relied on,
`Dr. Hay, I believe, was a report from Mylan's
`witness Dr. Corboy, Exhibit 1002, which I'm
`going to hand to you.
` Did you, in fact, consider this,
`Exhibit 1002?
` A Yes.
` Q Okay. Were you able to understand
`Dr. Corboy's report, Exhibit 1002?
` MR. CHAJON: Objection to form.
` THE WITNESS: Yes.
`BY MR. FELDSTEIN:
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`Joel Hay, Ph.D.
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`Mylan Pharmaceuticals Inc. v. Biogen MA, Inc.
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`October 21, 2019
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`Page 29
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` Q Can you turn to paragraph 66 in
`Exhibit 1002, paragraph 66 and 67.
` Are you familiar with these paragraphs?
`Take your time to review them.
` A Okay.
` Q What's your understanding of what
`Dr. Corboy is saying in paragraphs 66 and 67 of
`Exhibit 1002?
` MR. CHAJON: Objection to form.
` THE WITNESS: Okay. Could you repeat
`the question, please.
`BY MR. FELDSTEIN:
` Q Sure. What is your understanding of
`what Dr. Corboy is saying in paragraphs 66
`and 67, Exhibit 1002?
` A That the treatment with BG-12, which is
`essentially another name for DMF, led to a
`statistically significant reduction in the total
`number of gadolinium-enhanced brain lesions as
`measured by MRI with six months of treatment
`relative to placebo.
` Q And does Dr. Corboy address any other
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`Joel Hay, Ph.D.
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`Mylan Pharmaceuticals Inc. v. Biogen MA, Inc.
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`October 21, 2019
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`Page 30
`conclusions from the Phase II studies of BG-12?
` MR. CHAJON: Objection to form.
`Hearsay.
`BY MR. FELDSTEIN:
` Q To your understanding.
` A Well, he talks about the press release,
`and really he's just noting what was in the
`press release -- or some of what was in the
`press release relating to the primary endpoint
`and the fact that it appears to have achieved at
`least a statistically significant reduction. We
`don't know from this paragraph whether it's
`clinically significant, but it's statistically
`significant.
` Q Why do you distinguish statistically
`significant from clinically significant?
` A Because everyone does in the
`literature. Statistical significance -- you
`could show that some drug reduces risk of heart
`attack by .00000001 percent, one in a billion,
`let's say, and it's statistica
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