UNITED STATES PATENT AND TRADEMARK OFFICE
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
` -----------------------------------
` MYLAN PHARMACEUTICALS INC.,
` Petitioner
`
` vs
`
` NOVO NORDISK A/S,
` Patent Owner
` -----------------------------------
` Case IPR2023-00724
` U.S. Patent No. 10,335,462
`
`
`
` Oral deposition of
` DeFOREST McDUFF, Ph.D.
`
` WASHINGTON, DC
` FRIDAY, JULY 19, 2024
` 10:13 a.m. EASTERN TIME
`Job No.: 543602
`Pages: 1 - 72
`Reported by: Lisa V. Feissner, RDR, CRR, CLR
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`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
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`
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
` -----------------------------------
` MYLAN PHARMACEUTICALS INC.,
` Petitioner
`
` vs
`
` NOVO NORDISK A/S,
` Patent Owner
` -----------------------------------
` Case IPR2023-00724
` U.S. Patent No. 10,335,462
`
`
`
` Oral deposition of
` DeFOREST McDUFF, Ph.D.
`
` WASHINGTON, DC
` FRIDAY, JULY 19, 2024
` 10:13 a.m. EASTERN TIME
`Job No.: 543602
`Pages: 1 - 72
`Reported by: Lisa V. Feissner, RDR, CRR, CLR
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`Transcript of DeForest McDuff, Ph.D.
`Conducted on July 19, 2024
`
`2
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` Oral deposition of DeFOREST McDUFF,
`Ph.D., held at the offices of:
`
` GROOMBRIDGE, WU, BAUGHMAN & STONE LLP
` 801 17TH STREET, NW
` SUITE 1050
` WASHINGTON, DC 20006
` 202.505.5830
`
` Pursuant to Notice, before Lisa V.
`Feissner, RDR, CRR, CLR, Notary Public.
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`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
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`Transcript of DeForest McDuff, Ph.D.
`Conducted on July 19, 2024
`
`3
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`A P P E A R A N C E S:
`ON BEHALF OF PETITIONER:
` BRANDON M. WHITE, ESQUIRE
` PERKINS COIE LLP
` 700 Thirteenth Street, NW
` Suite 600
` Washington, DC 20005
` 202.265.6206
` bmwhite@perkinscoie.com
`
`ON BEHALF OF PATENT OWNER:
` PHILIP S. MAY, ESQUIRE
` J. STEVEN BAUGHMAN, ESQUIRE
` GROOMBRIDGE WU BAUGHMAN & STONE LLP
` 801 17th Street, NW
` Suite 1050
` Washington, DC 20006
` 202.539.6620
` philip.may@groombridgewu.com
` steve.baughman@groombridgewu.com
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`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
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`Transcript of DeForest McDuff, Ph.D.
`Conducted on July 19, 2024
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`4
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`A L S O P R E S E N T:
` MARCELLE DINA ZITA
` PRESTON IMPERATORE, ESQ., Mylan (Zoom)
` DAVID ANSTAETT, ESQ., Perkins Coie (Zoom)
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`Transcript of DeForest McDuff, Ph.D.
`Conducted on July 19, 2024
`
`5
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` C O N T E N T S
` EXAMINATION OF DeFOREST McDUFF, Ph.D. PAGE
` By Mr. May 6
`
` E X H I B I T S
` (Attached to transcript)
`EXHIBIT PAGE
`Ex. 2610 trackdrugs.com printout (two pages) 45
`
` P R E V I O U S L Y
` M A R K E D E X H I B I T S
` (identified but not attached)
`EXHIBITS PAGE
`MPI EXHIBIT 1172 32
`MPI EXHIBIT 1184 27
`MPI EXHIBIT 1185 39
`MPI EXHIBIT 1302 22
`MPI EXHIBIT 1308 7
`Novo Nordisk Exhibit 2300 55
`Novo Nordisk Exhibit 2308 50
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`Novo Nordisk Exhibit 2332 47
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`Transcript of DeForest McDuff, Ph.D.
`Conducted on July 19, 2024
`
`6
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` P R O C E E D I N G S
` DeFOREST McDUFF, Ph.D.,
`having been first duly sworn, was examined and
`testified as follows:
` EXAMINATION
`BY MR. MAY:
` Q Can you please state and spell your name
`for the record.
` A Yes. DeForest McDuff, D-E capital
`F-O-R-E-S-T, M-C capital D-U-F-F.
` Q Who is your current employer?
` A Insight Economics LLC and University of
`North Carolina at Chapel Hill.
` Q Dr. McDuff, you've been deposed before,
`correct?
` A Yes.
` Q So I won't go over the full ground rules.
`I assume you're familiar with the deposition
`process, give yes, no answers, not speaking over
`each other.
` A Yes, that's fine.
` Q I will do my best today to ask clear
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`Transcript of DeForest McDuff, Ph.D.
`Conducted on July 19, 2024
`
`7
`
`questions. However, in the event that I do not do
`so or you have any questions, please ask me for
`clarification, okay?
` A I'll do my best.
` Q If you don't ask me for clarification,
`I'm going to assume that you understood the
`questions I've posed.
` Is that fair?
` A Again, I'll do my best.
` Q Is there anything that would prevent you
`from giving truthful and accurate testimony today?
` A No.
` (Previously marked Exhibit 1308 presented
`to the witness.)
`BY MR. MAY:
` Q You have in front of you a copy of your
`declaration in this case marked as Exhibit 1308?
` A Yes, that's right.
` Q And that's a full copy, including all
`appendices?
` A Yes.
` Q So Dr. McDuff, if I can turn you to
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`Transcript of DeForest McDuff, Ph.D.
`Conducted on July 19, 2024
`
`8
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`paragraph 15 of your declaration.
` A Okay.
` Q So it's your opinion that there is only a
`limited connection between the claimed commercial
`success and novel contributions of the claimed
`subject matter of the patent at issue here?
` MR. WHITE: Objection to form.
` A Yes.
` Q And what do you mean by "a limited
`connection"?
` A In evaluating nexus, we refer to the
`degree of connection between the claimed subject
`matter and the product performance. And here I'm
`saying that that is a limited or somewhat weak
`connection.
` Q Do you dispute marketplace success for
`Ozempic?
` MR. WHITE: Object to form.
` A What do you mean by that?
` Q Is it your opinion that Ozempic has not
`been a commercial success?
` A It depends what you mean by "commercial
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`Conducted on July 19, 2024
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`9
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`success" in that context. Could you clarify?
` Q Well, how can I clarify for you better?
`I think that question is pretty clear.
` A I would say it like this. As indicated
`in my declaration, I agree that Ozempic has achieved
`a certain amount of product success overall, but
`that that product success does not necessarily bear
`on the claimed invention of the '462 patent.
` Q What do you mean by "a certain amount of
`product success"?
` A What I mean is, clearly Ozempic has
`earned significant sales, yet there are some
`limitations to Dr. Vellturo's analysis, which I set
`forth in my declaration.
` Q So just to make sure I understand, you're
`not disputing that Ozempic, as the drug, is a
`commercial success, right?
` MR. WHITE: Objection, form.
` A It depends what you mean by "commercial
`success." As a secondary consideration, I think
`it's more complicated. In terms of its product
`performance, I am not disputing that it has achieved
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`Conducted on July 19, 2024
`
`10
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`a certain product success overall.
` Q You keep saying "a certain product
`success." What do you mean by "certain"?
` A Well, "product success" is not very well
`defined. It depends what you mean by "product
`success."
` Q Is it your opinion that Ozempic is not
`successful as a product?
` MR. WHITE: Object to the form.
` A I'm not putting it that way.
` Q So it's not -- it is not your opinion
`that Ozempic is not commercially successful?
` MR. WHITE: Object to the form.
` A That's a hard question to answer. I'm
`not sure what you're asking.
` Q Yeah, that's fair. So let me try that
`again.
` You are not opining that Ozempic has not
`been commercially successful, correct?
` MR. WHITE: Objection to form.
` A It depends what you mean by that. I'm
`evaluating commercial success as a secondary
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`Conducted on July 19, 2024
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`11
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`consideration. And I've got many opinions on that.
`It's not a black or white, yes or no type of
`opinion.
` Q If you can turn to paragraph 21 of your
`declaration, please.
` And for today's purposes, when I say
`"your declaration," you'll understand that that's
`Exhibit 1308, right?
` A Yes, of course.
` Q So in paragraph 21 of your declaration,
`you identify some criticisms of Dr. Vellturo's
`opinion. Specifically starting at around the second
`sentence, you criticize him for not providing an
`analysis of profits, costs, or risk-adjusted returns
`associated with the claimed subject matter, even
`though these factors are commonly evaluated for
`commercial success.
` Do you see that?
` A Yes.
` Q What's your basis for saying that those
`factors are commonly evaluated for commercial
`success?
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`Transcript of DeForest McDuff, Ph.D.
`Conducted on July 19, 2024
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`12
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` A I've worked on many cases as an expert on
`the topic of commercial success. I'm very familiar
`with case law on commercial success. I'm familiar
`with publications on commercial success.
` And profits and the profit motive is a
`core part of what commercial success is about, from
`an economic perspective.
` Q Have you undertaken an analysis of the
`profits, costs, or risk-adjusted returns associated
`with the claimed subject matter?
` A I have not because that information was
`not provided by Dr. Vellturo.
` Q If you can turn to paragraph 26 of your
`declaration.
` In paragraph 26, you criticize
`Dr. Vellturo for evaluating Ozempic in the context
`of the modern noninsulin antidiabetics market, the
`MNIAD market.
` Do you see that?
` A Yes.
` Q And it's your opinion that that market is
`unnecessarily limiting?
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`Conducted on July 19, 2024
`
`13
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` A Yes.
` Q What do you believe the appropriate
`market would be?
` A In my view, the right market definition
`would be treatments of type 2 diabetes.
` Q All treatments of type 2 diabetes?
` A Generally, yes, with some limitations.
` Q What are those limitations?
` A For example, you might not include things
`like exercise and diet, but treatments that are
`medicines or insulins would be included in that
`definition.
` Q And what's your basis for using that as
`the market definition rather than the MNIAD market
`definition?
` A That's how economists think about market
`definition in the pharmaceuticals industry, which
`is, what are the potential products available to
`treat the diagnosis of interest. That's how
`economists think about the market.
` Q Did you cite any sources in your
`declaration that confirm that that's how economists
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`14
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`think about the market?
` A I don't recall, but I think that's pretty
`well understood.
` Q Turning to the second half of the
`paragraph 26 on page 15 of your declaration, you
`state that, The low share of GLP-1s in the diabetes
`market at priority would have provided more limited
`incentives for development.
` Do you see that?
` A Yes.
` Q So "at priority," you're referring --
`what date are you referring to for "at priority"?
` A Give me just a minute to look at my
`declaration.
` I'm referring to the claimed priority of
`the '462 patent. To my understanding, that's in or
`around 2012.
` Q Why would the low share of GLP-1s in the
`diabetes market, according to you, as of 2012
`provide more limited incentives for development?
` (Reporter interruption.)
` Q Why would the low share of GLP-1s in the
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`Conducted on July 19, 2024
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`15
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`diabetes market, according to you, as of 2012
`provide more limited incentives for development?
` A Because that represents a relatively
`smaller market opportunity, all else being equal.
` Q So I want to unpack that a little bit.
` How does it represent a relatively
`smaller market opportunity?
` A If GLP-1s have a low share of the market,
`that's a smaller opportunity for GLP-1s.
` Q It's not possible for the GLP-1 share to
`grow?
` A I'm not saying it's not possible.
` Q How does the fact that it's low as of
`2012 mean that it disincentivized a researcher from
`exploring GLP-1 opportunities?
` MR. WHITE: Object to form.
` A If one thinks about the market
`opportunity for GLP-1s and it's relatively small
`around the time of the priority because the share is
`low, that represents a smaller opportunity for
`products.
` Q You would agree the GLP-1 share of the
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`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
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`Transcript of DeForest McDuff, Ph.D.
`Conducted on July 19, 2024
`
`16
`
`diabetes treatment marketplace has exploded since
`2012, correct?
` MR. WHITE: Objection to form.
` A I haven't used that language.
` Q That's fair. You would agree that the
`share of GLP-1s in the diabetes marketplace has
`increased since 2012, correct?
` A I agree with that.
` Q Are you aware of by what degree it has
`increased since 2012?
` MR. WHITE: Objection to form.
` A I don't have the figures in front of me
`right now.
` Q You included a figure in your declaration
`on page 16. This is Figure 1. And this comes from
`a Novo Nordisk 2017 market overview presentation?
` A Yes.
`
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`Mylan Pharms. Inc. v. Novo Nordisk A/S
`IPR2023-00724
`Page 00016
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`Transcript of DeForest McDuff, Ph.D.
`Conducted on July 19, 2024
`
`17
`
`
`
`
` Q If you can turn to paragraph 31 of your
`declaration. About halfway down the paragraph on
`page 18, you have a statement that says, Notably,
`Dr. Goland testified that she had not reviewed any
`prior art to the '462 patent.
` Do you see that?
` A Yes.
` Q Why was that notable to you?
` A It's notable because the idea of
`coextensiveness is whether the claimed invention
`aligns with the product overall.
` And if Dr. Goland is advising
`Dr. Vellturo on coextensiveness and she has not
`reviewed the prior art, I don't see how she can make
`a conclusion of coextensiveness if she doesn't
`compare what is allegedly innovative about the '462
`patent to what existed before the '462 patent.
` Q Do you have any independent opinions on
`what is new in the '462 patent as opposed to what
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`Mylan Pharms. Inc. v. Novo Nordisk A/S
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`Transcript of DeForest McDuff, Ph.D.
`Conducted on July 19, 2024
`
`18
`
`existed in the prior art?
` A I'm not providing a technical opinion of
`that kind. I'm providing an economic analysis.
` Q And who are you relying on for your
`technical information?
` A Give me just a moment.
` I'm relying upon Dr. Spiegel and
`Dr. Schwartzbard.
` Q And are you relying solely on their
`declarations submitted in this IPR?
` A Yes.
` Q Did you ever have any communications with
`either Dr. Spiegel or Dr. Schwartzbard?
` A No.
` Q And did you only review the declarations
`from them in their final signed form?
` A Yes.
` Q You didn't review any drafts at all
`during your process of drafting your report?
` A I did not.
` Q Aside from the information you've
`received from Dr. Spiegel and Dr. Schwartzbard, you
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`Transcript of DeForest McDuff, Ph.D.
`Conducted on July 19, 2024
`
`19
`
`don't have any independent technical opinions
`regarding coextensiveness, right?
` A That's correct.
` Q And you also -- aside from the
`information you received from Dr. Spiegel and
`Dr. Schwartzbard, you don't have any independent
`opinions on how the '462 patent reads onto Ozempic,
`right?
` A In terms of technical opinions, I'm not
`providing those.
` Q So if you turn to paragraph 33 of your
`declaration.
` A Okay.
` Q About halfway down the paragraph, you
`state, At best, the novel aspects of the '462 patent
`are limited to the 1.0 milligram dosing regimen (and
`even this is disputed).
` Do you see that?
` A Yes.
` Q What's your basis for that opinion?
` A My basis is my understanding from counsel
`and the Spiegel reply declaration as well as what is
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`Page 00019
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`Transcript of DeForest McDuff, Ph.D.
`Conducted on July 19, 2024
`
`20
`
`being asserted by Novo Nordisk here in this
`proceeding.
` Q I guess -- so what is your understanding
`of what that means for the novel aspects of the '462
`patent to be limited to the 1.0 milligram dosing
`regimen?
` A What I understand that to mean is that in
`terms of what's claimed and novel for the '462
`patent, it's only the specific amount of dosing, the
`1.0 milligrams, compared to prior art, which prior
`art includes the active ingredient, dosing ranges,
`and other elements of treatment.
` Q What's your basis for understanding that
`the prior art includes the active ingredient, dosing
`range, and other elements of treatment?
` A That's described elsewhere in my
`declaration. I believe I go into it in some detail.
` Q You said your basis for understanding
`from this sentence was based on Dr. Schwartzbard and
`Dr. Spiegel and also from counsel.
` Is that right?
` A Yes.
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`Transcript of DeForest McDuff, Ph.D.
`Conducted on July 19, 2024
`
`21
`
` Q How did counsel inform your
`understanding?
` A I discussed my declaration with counsel
`as I was writing it, and they helped me understand
`the technical aspects in terms of what was alleged
`to be novel about the '462 patent.
` Q So this is not an independent opinion
`that you have regarding the novel aspects of the
`'462 patent, correct?
` A I agree with that. This is my
`understanding as an economist.
` Q If you can turn to paragraph 39 of your
`declaration.
` A Okay.
` Q And specifically the second half of
`paragraph 39 on page 24.
` You write that, absent a 1.0 milligram
`dosing regimen, certain of the same patients could
`have been treated with alternative dosing regimens
`that do not fall within the scope of the '462 patent
`(e.g., by remaining on a 0.5 milligram dose...)
` Do you see that?
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`Transcript of DeForest McDuff, Ph.D.
`Conducted on July 19, 2024
`
`22
`
` A Yes.
` Q And for that sentence, you cite to
`Dr. Spiegel's reply declaration at paragraphs 220 to
`222.
` Is that right?
` A Yes.
` MR. MAY: If we can take a look at
`Dr. Spiegel's declaration, which is Exhibit 1302.
` (Previously marked Exhibit 1302 presented
`to the witness.)
`BY MR. MAY:
` Q So I've handed you Exhibit 1302, which is
`Dr. Spiegel's reply declaration. And if we can
`please turn to paragraphs 220 through 222 located on
`page 76.
` A Okay, I'm there.
` Q All right. In paragraph 220,
`Dr. Spiegel, second sentence from the bottom,
`writes, The label instructs to depart from this
`initial treatment dose only if, with emphasis on
`only if, quote, additional glycemic control is
`needed after at least four weeks on the 0.5
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`Transcript of DeForest McDuff, Ph.D.
`Conducted on July 19, 2024
`
`23
`
`milligram dosage, end quote.
` Do you see that?
` A Yes.
` Q So Dr. Spiegel is saying that you only
`depart from the 0.5 milligram dosage to the 1.0
`milligram dosage only if additional glycemic control
`is needed, right?
` A I see that language here.
` Q And then in paragraph 222, Dr. Spiegel
`also explains, starting towards the end of the
`second line of that paragraph, the 1.0 milligram
`dose is reached only if additional glycemic control
`is needed after a patient uses the 0.5 milligram
`dose for at least four weeks.
` Do you see that?
` A Yes.
` Q And you don't have any reason to disagree
`with Dr. Spiegel, right?
` A I'm not offering any disagreement with
`Dr. Spiegel.
` Q So you understand that Dr. Spiegel says
`that the only reason you would go to 1.0 milligram
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`Mylan Pharms. Inc. v. Novo Nordisk A/S
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`10:37:09
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`Transcript of DeForest McDuff, Ph.D.
`Conducted on July 19, 2024
`
`24
`
`is if additional glycemic control is needed after
`having tried the 0.5 milligram dose, right?
` A I would defer to Dr. Spiegel for whether
`that's an accurate paraphrase. I see some of the
`language here that you just said in his declaration.
` Q You can put Dr. Spiegel's declaration
`away for right now. Well, we're going to come back
`to it soon.
` If you turn to paragraph 44 of your
`declaration. And specifically the portion on
`page 26.
` You write that you understand that other
`Ozempic patents listed in the FDA Orange Book cover
`the compound, device, and other features.
` Do you see that?
` A Yes.
` Q Do you have any technical understanding
`for how the other Ozempic patents listed in the FDA
`Orange Book relate to Ozempic?
` A No. I'm not providing a technical
`evaluation of those patents. In this paragraph, I'm
`simply pointing out that Dr. Vellturo should have
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`Mylan Pharms. Inc. v. Novo Nordisk A/S
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`10:38:37
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`Transcript of DeForest McDuff, Ph.D.
`Conducted on July 19, 2024
`
`25
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`analyzed the other patents listed in the Orange Book
`as part of his nexus analysis.
` Q If you can turn back to Dr. Spiegel's
`declaration, which is Exhibit 1302. And if you can
`turn to paragraph 49 of Dr. Spiegel's declaration,
`and section heading V.
` A Okay, I'm there.
` Q And section heading V, is Relevant Novo
`Nordisk Patents and Claims.
` Do you see that?
` A Yes.
` Q And then in paragraph 49, Dr. Spiegel
`goes on to say that, Among the patents listed --
`sorry. Strike that.
` In paragraph 49, starting at the bottom
`of page 24, Dr. Spiegel says, Among the patents
`listed in the Orange Book for Ozempic, are U.S.
`Patent Nos. 8,114,833, 8,129,343, 8,536,122 and
`10,335,462.
` Do you see that?
` A Yes.
` Q And then Dr. Spiegel has a footnote,
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`Transcript of DeForest McDuff, Ph.D.
`Conducted on July 19, 2024
`
`26
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`footnote number 5, states that, I am informed that
`other Orange Book patents relate to devices and so
`are not relevant here.
` Do you see that?
` A Yes.
` Q Do you have any basis to disagree with
`Dr. Spiegel?
` A I'm not disagreeing with Dr. Spiegel's
`perspective here, yet they still may be relevant to
`an economic evaluation of nexus.
` Q And Dr. Spiegel is who you rely on for
`your technical understanding of the patents involved
`here, correct?
` A That's true.
` Q Okay. I want to shift gears for a little
`bit to talk about your opinions regarding off-label
`usage. So can we turn to paragraph 53.
` You cite to a Washington Post article in
`support of your opinions.
` Is that correct?
` A Yes.
` Q The Washington Post article, is that a
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`Transcript of DeForest McDuff, Ph.D.
`Conducted on July 19, 2024
`
`27
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`peer-reviewed journal article?
` A No, it's not.
` Q And the Washington Post article is
`relying on data from Trilliant Health, as you note,
`correct?
` A Yes.
` Q And then you cite to the Trilliant Health
`report itself, right?
` A Yes.
` MR. MAY: So if we can take a look at
`that, Exhibit 1184.
` (Previously marked Exhibit 1184 presented
`to the witness.)
`BY MR. MAY:
` Q So Exhibit 1184, this is the Trilliant
`Health report that you reference and that the
`Washington Post referenced?
` A Yes.
` Q So if we can look at page 43 of
`Exhibit 1184, which you cited to in your report.
` A Yes.
` Q This ch
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