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`Amneal Pharmaceuticals, et al., v. Almirall, S.A. Elaine Gilmore, M.D., Ph.D.
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`Page 1
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` UNITED STATES PATENT AND TRADEMARK OFFICE
` ----------------------------
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
` ----------------------------
` AMNEAL PHARMACEUTICALS LLC AND AMNEAL
` PHARMACEUTICALS OF NEW YORK LLC
` Petitioner
` v.
` ALMIRALL, S.A.
` Patent owner
` -----------------------------
` Case No. IPR2019-00207
` U.S. Patent 9,517,219
`
` DEPOSITION OF ELAINE S. GILMORE, M.D., Ph.D.
` Washington, D.C.
` July 25, 2019 at 9:01 a.m.
`
`Reported by: Michele E. Eddy, RPR, CRR, CLR
` ____________________________________________________
` DIGITAL EVIDENCE GROUP
` 1730 M Street, NW, Suite 812
` Washington, D.C. 20036
` (202) 232-0646
`
`www.DigitalEvidenceGroup.com
`
`Digital Evidence Group C'rt 2019
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`1 of 44
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`Almirall EXHIBIT 2062
`
`Amneal v. Almirall
`IPR2019-00207
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`

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`7/25/2019
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`Amneal Pharmaceuticals, et al., v. Almirall, S.A. Elaine Gilmore, M.D., Ph.D.
`
` A P P E A R A N C E S
`
`ON BEHALF OF THE PETITIONER:
` DENNIES VARUGHESE, PHARM.D., ESQUIRE
` TYLER LIU, ESQUIRE
` ADAM C. LaROCK, ESQUIRE
` Sterne, Kessler, Goldstein & Fox,
` P.L.L.C.
` 1100 New York Avenue, Northwest
` Washington, D.C. 20005
` Telephone: (202) 371-2600
` dvarughe@sternekessler.com
` tliu@sternekessler.com
` alarock@sternekessler.com
`
`ON BEHALF OF THE PATENT OWNER:
` JAMES TRAINOR, ESQUIRE
` Fenwick & West, LLP
` 902 Broadway, Suite 14
` New York, New York 10010
` Telephone: (212) 430-2749
` jtrainor@fenwick.com
`
`Page 2
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` EXAMINATION INDEX
` PAGE
`EXAMINATION BY MR. TRAINOR 5
`
` E X H I B I T S
`DEPOSITION EXHIBIT PAGE
`Exhibit 1 Declaration of Elaine S. Gilmore, 5
` M.D., Ph.D., in the Case
` IPR2019-00207; AMN1018
`Exhibit 2 Curriculum Vitae of Elaine S. 5
` Gilmore, M.D., Ph.D.; AMN1019
`Exhibit 3 U.S. Patent No. 9,517,219, AMN1001 5
`Exhibit 4 PDR excerpt, 2011 Edition; AMN1010 42
`Exhibit 5 Article titled "Innovative Use 55
` of Dapsone" by V.E. Gottfried
` Wozel, M.D.; AMN1022
`Exhibit 6 WO 2009/061298; AMN1004 62
`Exhibit 7 Article titled "Treatment of 98
` acne vulgaris" by Rebecca Nguyen
` and John Su; AMN1024
`Exhibit 8 Article titled "Pharmacokinetics 123
` of Dapsone Gel, 5% for the
` Treatment of Acne Vulgaris" by
` Diane M. Thiboutot, etc.; AMN1023
`Exhibit 9 (Not used)
`Exhibit 10 WO2009/108147; Admirall, LLC 141
` Exhibit 2001
`
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`Deposition of ELAINE S. GILMORE, M.D.,
`Ph.D., held at the offices of:
` STERNE, KESSLER, GOLDSTEIN & FOX P.L.L.C.
` 1100 New York Avenue, Northwest
` Suite 600
` Washington, D.C. 20005
` (202) 371-2600
`
` Pursuant to Notice, before Michele E.
`Eddy, Registered Professional Reporter, Certified
`Realtime Reporter, and Notary public in and for
`the District of Columbia.
`
` P R O C E E D I N G S
` Washington, D.C.
` July 25, 2019
` - - -
` ELAINE S. GILMORE, M.D., PH.D.,
`having been duly sworn, testified as follows:
` EXAMINATION BY COUNSEL FOR THE PATENT OWNER
`BY MR. TRAINOR:
`
`Page 4
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` Q Good morning, Dr. Gilmore. Thanks very
`much for being here today. I know there are other
`places you would rather be. I'll do my best to
`get through this today.
` Before we get on the record, I asked the
`court reporter just to mark for your own
`identification, for identification of the record,
`three documents, which are exhibits in this
`petition which brings us here today, which is a
`petition for inter partes review of U.S. Patent
`Number 9,517,219. This is IPR2019-00207.
` (Exhibit 1, Exhibit 2, and Exhibit 3 were
`marked for identification and attached to the
`deposition transcript.)
`BY MR. TRAINOR:
` Q Dr. Gilmore, the first document I would
`like you to just take a look at is marked Exhibit
`-- what's been designated as Exhibit No. 1018 in
`this proceeding, which appears to be your
`declaration submitted in this case; is that right?
` Do you see that?
` A I see it.
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` Q Okay. Also in front of you is Exhibit
`1019, which is an exhibit to your declaration. It
`appears to be your CV. Do you see that?
` A I see it.
` Q Okay. And the third document I asked to
`be marked is Exhibit 1001 of record in this
`proceeding, and that is United States Patent
`9,517,219.
` Do you see that?
` A I see it.
` Q Okay. And you understand that what I
`will refer to as the '219 patent, Exhibit 1001, is
`the patent in dispute in these proceedings?
` A I understand.
` Q Okay. And the declaration, Exhibit
`1018, is a declaration you submitted in support of
`the petitioner's petition for IPR in this case,
`correct?
` A Correct.
` Q I only put these three documents in
`front of you preliminarily in case -- you know,
`we'll probably refer to your declaration a bit. I
`Page 6
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`wanted you to be able to have that in front of you
`and refer to it whenever you feel the need to.
`The same thing with the patent. I'm going to
`begin by just asking you a few questions about
`your CV so that's why I put that in front of you
`as well.
` So, Dr. Gilmore, in another U.S. patent
`office proceeding related to a different patent
`but between these same parties, you gave a
`deposition, I believe, in the last year or so. Do
`you recall?
` A Yes.
` Q Have you had a chance to review the
`transcript of that deposition?
` A Not completely.
` Q Is there anything that you can think of
`that you provided testimony about at that time
`that you realize you want to clarify or anything
`like that?
` A I haven't reviewed the whole document.
`Nothing comes to mind.
` Q Okay. You understand that we're here
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`today in conjunction with a separate dispute
`concerning a separate patent. Is that right?
` A Yes.
` Q Now, if we could just turn to Exhibit
`1019, which is your CV, you were asked about this
`at your past deposition. I just have a few
`questions.
` I just want to be clear, your -- the
`time when you would have begun treating patients
`for dermatologic conditions would have been during
`your residency at Yale; is that correct?
` A I also treated patients during my
`internship in California.
` Q Okay.
` A And as a medical student.
` Q As a medical student.
` So as part of seeing patients for
`general internal medicine, you would have treated
`patients for dermatological conditions; is that
`right?
` A Yes.
` Q And would that have been -- what
`
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`percentage of the patients before your residency
`would have been patients seeing you for
`dermatological conditions?
` A I don't remember exactly, but primary
`care physicians treat a lot of skin disease,
`including acne.
` Q And a lot of other conditions, correct?
` A Yes.
` Q So I'm just trying to establish if there
`was a focus on dermatology in the time prior to
`your residency, or no.
` A Prior to my dermatology residency?
` Q Correct.
` A No, but it's quite frequently seen by
`internal medicine doctors.
` Q So would -- if we just begin with your
`residency in 2004, that would put us at about 15
`years you've been treating patients; is that
`right?
` A If we want to talk about the start of
`dermatology residency, yes.
` Q With respect to the publications listed
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`on the second page and across to the third page of
`your CV, could you identify which, if any, report
`in any way on the treatment of the condition of
`acne.
` A None specifically. I don't recall the
`first content of the immunocompromised patients.
`There we discussed a lot of different conditions
`so I'm not sure if there's anything within that.
` Q Which number is that?
` A No. 15.
` Q I'll ask a similar question. To your
`recollection, do any of these publications that
`you authored or coauthored concern the treatment
`of rosacea?
` A I don't believe they do.
` Q To your recollection, do any of these
`publications concern or otherwise report about the
`use of dapsone?
` A No, they do not.
` Q And do any of these publications, to
`your recollection, concern or otherwise report on
`the use of adapalene?
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` A No, they do not.
` Q Just turning back to the front page of
`your CV, you've listed a number of honors and
`awards. I see the second entry is an
`"International Investigative Dermatology Meeting,
`'Poster Walk.'"
` Do you see that?
` A Yes.
` Q What kind of an award is that?
` A This was an international meeting where
`the organizers choose some of the best research to
`highlight on a kind of tour of the research on
`display.
` Q So that be more an honor than an actual
`award, correct?
` A Yes. The title is "Honors and Awards."
` Q Would you similarly characterize the
`next entry directed to the "7th World of Congress
`on Itch" as an honor rather than an award?
` A That was called a Travel Award.
` Q Travel grant?
` A It was called the Travel Award.
`
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` Q Travel Award.
` So what was the award there?
` A That they funded my travel to the
`meeting.
` Q I see.
` A It was something given by the meeting
`you had to apply for.
` Q And you received a Dermatology
`Foundation Fellowship Grant at Yale Medicine, Yale
`Medical School.
` Did you need to apply for that grant?
` A Yes, that is very competitive.
` Q And was it part of the application
`process related to dermatology specifically? How
`is it that the Dermatology Foundation provided
`that grant to you?
` A It was dermatology research.
` Q That you had done before applying for
`the grant?
` A The grant covered the research to be
`done.
` Q I see. I see.
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` So aside from any of the three events or
`grants -- three awards -- sorry -- any of the two
`honors in the fellowship grant, are any of the
`honors or awards listed on your CV specific to
`dermatology or do they relate to medicine or more
`generally?
` A I'm not sure I understand your question.
` Q I'm just trying to find out which of the
`honors or awards here are anchored to your
`practice of dermatology as opposed to, for
`example, being a mentor or the best teacher or
`generally a good doctor.
` A I see.
` So everything from 2007 to present is
`related to dermatology.
` Q Okay.
` A Including a teaching award where I'm
`teaching dermatology residents dermatology.
` Q Okay. So does lymphoma connect with
`dermatological conditions?
` A Lymphoma is a broad disease, and one of
`the manifestations is a rare type called cutaneous
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`T-cell lymphoma.
` Q Okay.
` A Often these patients present with itch,
`and so dermatologists frequently are those who
`diagnose it.
` Q Okay. You can put the CV aside, but,
`again, if you feel the need to refer back to it at
`any point, it's there for you.
` I would like to take a look at the
`patent that's in dispute here. I'll probably
`refer to it more often than not as the '219 patent
`rather than Exhibit 1001, but those are the same
`thing.
` Have you had the occasion to review the
`'219 patent recently?
` A Yes.
` Q Okay. Did you review the '219 patent --
`well, when was the last time you reviewed it?
` A I reviewed the parts relevant to me
`yesterday.
` Q Okay. I want to ask you to turn to the
`claims at the back of the '219 patent, which begin
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`at column 15 and/or in column 16. Do you see
`column -- do you see claim 6?
` A I see it.
` Q Okay.
` Now, do you understand what a dependent
`claim is?
` A No.
` Q Okay. You see in the next claim, claim
`7, it says, "The method of claim 6, wherein the
`topical pharmaceutical composition further
`comprises methyl paraben."
` A I see where it says that.
` Q So if I represent to you that that means
`claim 7 is everything that claim 6 is, plus the
`additional element of claim 7, you -- you
`understand sort of the concept?
` A Yes.
` Q If I ask you the same question about
`claim 8 where it says, "The method of claim 6,
`wherein the dermatological condition is acne
`vulgaris," you have the same understanding,
`correct? That is just claim 6 but specific to
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`acne vulgaris.
` A Okay.
` Q All right. So thinking about what claim
`8 entails, which is everything in claim 6, plus
`further limited to the condition being acne
`vulgaris, is it your understanding that what is
`set forth there, claim 6 combined with claim 8, is
`the Aczone 7.5 percent formulation that I believe
`you use in your practice?
` DR. VARUGHESE: Objection to the extent
`it calls for a legal conclusion and it's outside
`the scope of Dr. Gilmore's declaration.
` Q Let me ask you a question this way. Are
`you familiar with the composition of the Aczone
`7.5 percent formulation?
` A What do you mean by "composition"?
` Q Anything about the composition beyond
`the fact that the concentration of the active
`ingredient is 7.5 percent.
` DR. VARUGHESE: Objection. Vague and
`ambiguous.
` A I know that the 7.5 percent product
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`exists because I use it in my clinic. I didn't
`look any further into it, though, as far as
`composition.
` Q Whether it's for the deposition or not,
`I'm just trying to understand, what is your
`familiarity or understanding of the commercial
`dapsone 7.5 percent formulation besides the fact
`that the active ingredient concentration is 7.5
`percent?
` DR. VARUGHESE: Objection. Asked and
`answered.
` A I know that the product exists and I use
`it for the treatment of acne.
` Q So you're not really familiar with the
`excipients beyond the active ingredient or how
`they make up the composition relative to the
`active ingredient?
` A That's probably better answered by a
`formulator and a clinician.
` Q That's fine. That's what I'm trying to
`understand.
` If I were to ask you can you describe to
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`me what the vehicle is for the 7.5 percent
`formulation, could you answer that?
` DR. VARUGHESE: Objection. Outside the
`scope of the declaration.
` A That's not relevant to my practice, not
`something I consider.
` Q Okay. And just for the record, I'll ask
`you, if I ask you if you're familiar with the
`vehicle used in the Aczone 5 percent formulation,
`would your answer be the same?
` DR. VARUGHESE: Objection. Outside the
`scope of the declaration.
` A Not something that I've considered. I
`know that these two products exist.
` Q Okay. Are you familiar with the term
`"vehicle"?
` A Yes.
` Q What does that mean to you in your
`practice?
` DR. VARUGHESE: Objection. Outside the
`scope.
` A It's not something that I am typically
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`considering outside of thinking of the form of how
`something might be delivered, a cream, an
`ointment, a gel.
` Q I see.
` So it would be at the level of the type
`of topical, gel, cream?
` A Yes.
` Q But beyond that, you wouldn't be
`familiar or have opinions with regard to what
`sorts of pharmaceutical excipients serve as better
`or worse vehicles for a given patient
`circumstance, correct?
` A I would not think about those.
` Q Okay, that's fine.
` Now, if we could turn back more to the
`beginning of the '219 patent, we have the cover
`page. We turn over a few pages of figures and the
`text sort of begins in earnest in column 1. Do
`you see that?
` A I do.
` Q Now, let me ask you a question. In your
`declaration you offered, for example, an opinion
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`as to the definition of the person -- the
`hypothetical person of ordinary skill in the art
`as it pertains to your analysis, correct? And
`your declaration, I think -- so, for example, at
`paragraph 15 on page 6 of your declaration,
`there's a discussion there about the hypothetical
`person of ordinary skill in the art.
` A Yes.
` Q Okay. So my question for you is, in
`your view, what -- what is the art here or, I
`should say more specifically, what is the -- what
`is the scope of the art as you understand it? If
`you had to define -- strike the question.
` I'm asking you, are you able to define
`what the art is in the context of the person of
`ordinary skill in the art as you gave your view
`out?
` DR. VARUGHESE: Objection to the extent
`it calls for testimony outside of the scope of
`Dr. Gilmore's declaration.
` MR. TRAINOR: Well, she testified --
`she's declared what she thinks a person of
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`ordinary skill in the art is, and I'm just asking
`what does art mean in that phrase. So it's not
`outside the scope.
` DR. VARUGHESE: Same objection.
` A So I've considered this from the
`clinical perspective, and the art would be one who
`has an M.D. with board certification in
`dermatology, at least two years experience of
`dermatology, or otherwise treating skin
`conditions.
` Q Let's ask it this way. Let's look at
`the patent where I had you look in column 1. You
`see maybe just about a quarter of the way down,
`there's a heading that says "Field." Do you see
`that?
` A Yes.
` Q Okay. Let me just read that short
`passage into the record. It says, "The present
`embodiments relate generally to compositions
`useful for treating a variety of dermatological
`conditions. In particular, some embodiments
`relate to dapsone and dapsone/adapalene
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`compositions and methods for use thereof."
` Do you see that?
` A I see that.
` Q Okay. In determining what the pertinent
`art was in this case for purposes of your
`declaration, my question is, is the art the
`treatment of dermatological conditions generally
`or is the art more narrowly the treatment of
`conditions with dapsone or dapsone and adapalene?
` A From a clinical perspective, I would say
`using these items and others to treat acne in
`dermatologic conditions.
` Q Okay. So then is it fair to say that in
`your view, the relevant art here is the treatment
`of the broad class of dermatologic conditions with
`a broad number of agents as opposed to dapsone
`specifically?
` A I'm not sure there's a legal definition
`that -- as I'm not an attorney, I can't comment
`on, but from my perspective clinically, a person
`of ordinary skill in the art would be using tools
`to treat dermatologic conditions.
`
`Page 22
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` Q Okay. Conditions generally, correct?
` A Including acne specifically in this
`case.
` Q Including acne.
` A Yes.
` Q But broader than acne, correct?
` A Yes, I think.
` Q And the art would include at least
`pharmacotherapies more broad but including
`dapsone; is that correct?
` A I guess, yes.
` Q Okay. Okay. Now, turning back to the
`declaration and the paragraph we're looking at,
`paragraph 15. This is on page 6 of the
`declaration. Let me see here.
` On page 8 there is a heading that says,
`"The person of ordinary skill in the art." Do you
`see that?
` A I do.
` Q Now, in paragraph 20 you provide your
`view as to the definition of a person of ordinary
`skill in the art. "From the clinical side, as
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`www.DigitalEvidenceGroup.com
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`Digital Evidence Group C'rt 2019
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`possessing an M.D. with a board certification in
`dermatology and at least two years of experience
`in dermatology or otherwise treating skin
`conditions." Do you see that?
` A I do.
` Q Then there's an alternative definition
`that follows, which is largely the same but
`doesn't require board certification so long as
`they had more than two years of knowledge and
`experience treating skin conditions. Is that
`right?
` A I see that, yes.
` Q So effectively when you read these
`together, it's your opinion that the appropriate
`person of ordinary skill in the art for purposes
`of this dispute and your analysis is any medical
`doctor who's been treating dermatological
`conditions for at least two years; is that right?
` A It's reasonable to consider that after
`two years of experience in treating patients, they
`would have the knowledge and experience to be
`considered of ordinary skill.
`
`Page 24
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` Q Okay. So then, that being the case,
`would you agree with me that at the relevant time
`here, which I believe you've assumed is 2012 for
`purposes of your declaration, do you agree with
`that? Let me -- let me start the question -- make
`the record better.
` For purposes of your analysis, your
`assumption is that the date from which we should
`consider the hypothetically skilled artisan's view
`of the world is sometime in 2012. Is that right?
` A Yes.
` Q So is it fair to say that your
`conclusions reached and provided in your
`declaration can be summarized as a medical doctor
`having two years of dermatological experience
`would understand and recognize that the claimed
`invention that we just looked at, claim 6 and
`claim 8, would have been obvious based on what
`they knew at the time; is that right? It would
`have been a person with two years of experience
`treating dermatological conditions who is also a
`medical doctor would recognize that treatment with
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`Amneal Pharmaceuticals, et al., v. Almirall, S.A. Elaine Gilmore, M.D., Ph.D.
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`this claimed formulation of 7.5 percent dapsone is
`obvious. Is that correct?
` DR. VARUGHESE: Objection. Vague and
`ambiguous. Compound.
` A Can you clarify?
` Q On the day before the date in 2012 as
`the all important date here for purposes of the
`proper time point for the analysis, correct, in
`2012, okay? One day before that or on that date,
`it's your view that a person looking at the
`claimed invention, which includes a 7.5 percent
`concentration of dapsone, among other things,
`would have been obvious. Just based off of those
`two years of experience, they would understand
`treating with that formulation would have been
`obvious relative to what was known to that point.
`Is that right?
` A In light of the literature, yes.
` Q Now, in the next paragraph, paragraph
`21, you said that your view of the clinical
`POSA -- P-O-S-A is an acronym -- is rooted in the
`intrinsic record.
`
`Page 26
`
` What did you mean by the intrinsic
`record?
` A The patent.
` Q Okay. Just so I understand this
`correctly, when you make reference to the
`intrinsic record in your declaration, that would
`be limited to the patent; is that right?
` A I'm not an attorney. I don't know if
`there's another definition of intrinsic record,
`but that's what I'm referring to.
` Q Did you review what you would call the
`file history or the prosecution history that is --
`that resulted or ended up in the issuance of the
`'219 patent?
` A I'm not sure.
` Q Okay. If we could turn to page 6 of the
`declaration. So turn back. There are -- there's
`a chart. Do you see that?
` A Yes.
` Q The chart lists one, two, three, four,
`five, six, seven, eight, nine documents which
`correspond to exhibit numbers in this proceeding.
`Page 27
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`www.DigitalEvidenceGroup.com
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`Digital Evidence Group C'rt 2019
`
`Do you see that?
` A Yes.
` Q So my question is, beyond these nine
`documents, did you consider any other literature,
`as you say, or prior art beyond these documents?
` A These references were the things that I
`had focused on in the declaration.
` Q Can you talk to me about the process of
`how it came to be that you focused on these nine
`documents as distinguished from any other
`literature?
` DR. VARUGHESE: Before you answer,
`Dr. Gilmore, I'm going to lodge an objection and
`instruction that in answering this question,
`you're not to divulge any confidential
`communications with your counsel. But if you can
`answer without doing so, you may proceed.
` A These were things that we worked on
`together with counsel.
` Q Did you search for and find these
`documents on your own?
` A I don't remember specifically. Some of
`Page 28
`
`them were documents -- you know, we had a lot of
`references going back and forth. Some maybe.
` Q Some maybe.
` A Some definitely.
` Q Okay.
` Now, some definitely. So does it follow
`that you independently conducted a search of the
`literature in connection with your engagement by
`the petitioner in this case?
` A I did search for papers in the
`literature.
` Q Okay. And when you sat down to do the
`search, how did you -- how did you go about
`formulating your search?
` A What search engines did I use?
` Q We can start with that.
` A PubMed.
` Q PubMed, okay. Anything else?
` A I don't recall.
` Q Do you recall how you searched for
`literature on PubMed that you thought might be
`reflective of what the skilled artisan would have
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`Amneal Pharmaceuticals, et al., v. Almirall, S.A. Elaine Gilmore, M.D., Ph.D.
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`considered in 2012?
` A I don't specifically remember what
`search terms were used. This was quite a while
`ago and that's not something I have records of.
` Q Let me ask a different question. In
`conducting whatever search you did conduct to find
`relevant literature, did you try to put yourself
`in the shoes of the hypothetical POSA at the time
`in 2012?
` DR. VARUGHESE: Objection. Vague and
`ambiguous.
` A I don't remember specifically.
` Q Let me just ask this. You're giving an
`opinion as to who the skilled artisan would be and
`what they would have concluded at least in some
`respects so let me just ask the question this way.
`If you were a skilled artisan in 2012 and you
`somehow started down the road that would lead to
`the claimed invention here, what would you have
`done and what would you have looked to in the
`literature to guide you in that endeavor?
` DR. VARUGHESE: Objection. Calls for a
`Page 30
`
`legal conclusion. Outside the scope.
` MR. TRAINOR: Okay. Let me just stop
`right there. I'm not allowed to ask her what a
`person of ordinary skill in the art would have
`looked to in the course of arriving at the
`invention; is that correct?
` DR. VARUGHESE: Are you posing questions
`to me, Mr. Trainor?
` MR. TRAINOR: I am.
` DR. VARUGHESE: Then allow me to
`elaborate on my objection. I think your question
`is misleading. I think it's far outside the scope
`of what Dr. Gilmore testified to. And your
`question goes to the ultimate conclusion of
`obviousness. That's why I lodged that objection.
` MR. TRAINOR: Everything goes to the
`ultimate conclusion of obviousness. I note your
`objection.
`BY MR. TRAINOR:
` Q So, do you have a view as to a physician
`or other person practicing the method of treatment
`that's claimed in the patent, do you have a view
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`Digital Evidence Group C'rt 2019
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`as to when that person started down the road of
`trying to develop or find a new treatment, what
`resources they would have looked to, what
`literature they would have considered? Do you
`have a view on that?
` DR. VARUGHESE: Objection to the extent
`it calls for testimony outside the scope of the
`declaration.
` A It's not something I considered.
` Q Do you have an understanding as to the
`extent of the knowledge of the literature that a
`hypothetical person of ordinary skill in the art
`is presumed to have?
` A I would presume that someone at that
`time would have access to items that were
`published prior to that date.
` Q And given your prior testimony that the
`appropriate field or the definition of the
`relevant art here is the broad treatment of
`dermatological conditions with a broad number of
`agents, that would include a whole lot of
`literature, correct?
`
`Page 32
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` A Yes.
` Q So would you agree that a person of
`ordinary skill in the art in 2012 would have
`considered a good breadth of literature?
` A Yes.
` Q Do you believe they would have
`considered more than nine documents in that
`effort?
` DR. VARUGHESE: Objection. Vague and
`ambiguous.
` A You're asking me to speculate on what
`someone might think.
` Q Well, I am asking you to speculate
`because you're providing an opinion in this case,
`which by its very nature is speculation. And I'm
`just trying to ask whether you think a person of
`ordinary skill in the art in 2012 from a clinician
`perspective in searching the relevant art would
`have just arrived at these same nine documents
`that you did.
` DR. VARUGHESE: Objection. Vague and
`ambiguous. Mischaracterizes Dr. Gilmore's
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`Amneal Pharmaceuticals, et al., v. Almirall, S.A. Elaine Gilmore, M.D., Ph.D.
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`testimony. Misleading. Lacks foundation.
` MR. TRAINOR: Okay. I'll just note that
`the proceedings before the PTAB as far as I know
`are also governed by the Rules

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