1
`
` UNITED STATES PATENT AND TRADEMARK OFFICE
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
` + + + + +
`____________________________
` :
`IN THE MATTER OF: :
` :
`FLATWING PHARMACEUTICALS, :
`LLC AND MYLAN : Case Nos.
`PHARMACEUTICALS, LLC, : IPR2018-00168,
` : 2018-00169,
` Petitioners, : 2018-00170,
` : 2018-00171
` v. :
` : U.S. Patent Nos.
`ANACOR PHARMACEUTICALS, INC.: 9,549,938,
` : 9,566,289,
` Patent Owner. : 9,566,290,
` : 9,572,823
`____________________________:
` Wednesday,
` November 7, 2018
` Washington, D.C.
`
`DEPOSITION OF:
` MAJELLA E. LANE
`called for examination by Counsel for the
`Petitioner FlatWing Pharmaceuticals, pursuant to
`Notice of Deposition, at the law offices of
`Williams & Connolly LLP, located at 725 12th
`Street NW, when were present on behalf of the
`respective parties:
`
`(202) 234-4433
`
`Neal R. Gross and Co., Inc.
`Washington DC
`
`www.nealrgross.com
`FlatWing Ex. 1044, p. 1
`
`
`
` UNITED STATES PATENT AND TRADEMARK OFFICE
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
` + + + + +
`____________________________
` :
`IN THE MATTER OF: :
` :
`FLATWING PHARMACEUTICALS, :
`LLC AND MYLAN : Case Nos.
`PHARMACEUTICALS, LLC, : IPR2018-00168,
` : 2018-00169,
` Petitioners, : 2018-00170,
` : 2018-00171
` v. :
` : U.S. Patent Nos.
`ANACOR PHARMACEUTICALS, INC.: 9,549,938,
` : 9,566,289,
` Patent Owner. : 9,566,290,
` : 9,572,823
`____________________________:
` Wednesday,
` November 7, 2018
` Washington, D.C.
`
`DEPOSITION OF:
` MAJELLA E. LANE
`called for examination by Counsel for the
`Petitioner FlatWing Pharmaceuticals, pursuant to
`Notice of Deposition, at the law offices of
`Williams & Connolly LLP, located at 725 12th
`Street NW, when were present on behalf of the
`respective parties:
`
`(202) 234-4433
`
`Neal R. Gross and Co., Inc.
`Washington DC
`
`www.nealrgross.com
`FlatWing Ex. 1044, p. 1
`
`
`
`2
`
`APPEARANCES:
`
`On Behalf of Petitioner FlatWing
`Pharmaceuticals, LLC:
`PHILIP D. SEGREST, JR., ESQ.
`Husch Blackwell LLP
`120 South Riverside Plaza
`Suite 2200
`Chicago, Illinois 60606
`312-526-1548
`philip.segrest@huschblackwell.com
`
`On Behalf of Patent Owner Anacor
`Pharmaceuticals, Inc.:
`AARON P. MAURER, ESQ.
`ANTHONY H. SHEH, ESQ.
`Williams & Connolly LLP
`725 12th Street NW
`Washington, D.C. 20005
`202-434-5282 (Maurer)
`202-434-5436 (Sheh)
`amaurer@wc.com
`asheh@wc.com
`
`(202) 234-4433
`
`Neal R. Gross and Co., Inc.
`Washington DC
`
`www.nealrgross.com
`FlatWing Ex. 1044, p. 2
`
`
`
`3
`
` CONTENTS
`
`WITNESS DIRECT CROSS REDIRECT RECROSS
`
`Majella Lane 4 -- -- --
`
`EXHIBIT NO. PAGE
`
`2014 IPR 2018-00168, -00169, -00170,
` and -00171 . . . . . . . . . . . . . . . . . 9
`1046 FlatWing Exhibit . . . . . . . . . . . . . .14
`1007 Austin Reference . . . . . . . . . . . . . .46
`1014 Final Written Decision . . . . . . . . . . .48
`1001 '938 Patent. . . . . . . . . . . . . . . . .71
`1040 Exploration for Dose Response. . . . . . . .72
`
`(202) 234-4433
`
`Neal R. Gross and Co., Inc.
`Washington DC
`
`www.nealrgross.com
`FlatWing Ex. 1044, p. 3
`
`
`
`4
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`
` P-R-O-C-E-E-D-I-N-G-S
` 10:23 a.m.
`WHEREUPON,
` MAJELLA E. LANE
`was called as a witness by Counsel for the
`Petitioner and, having been first duly sworn,
`assumed the witness stand, was examined and
`testified as follows:
` DIRECT EXAMINATION
` BY MR. SEGREST:
` Q Good morning, Dr. Lane. I'm Philip
`Segrest. I'm representing FlatWing this morning.
`We had a scheduling error that's delayed our
`start a little bit, and I apologize for that.
`That was my fault. But we're getting started,
`and we're counting the delay against my time that
`I would've had with you. So we'll try to get
`done as quickly as we can.
` MR. MAURER: Before you go on, let me
`just -- if I could enter my appearance on the --
` MR. SEGREST: Sure.
` MR. MAURER: -- record too. Aaron
`
`(202) 234-4433
`
`Neal R. Gross and Co., Inc.
`Washington DC
`
`www.nealrgross.com
`FlatWing Ex. 1044, p. 4
`
`
`
`5
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`
`Maurer for Patent Owner. Here with me is Tony
`Sheh. Thank you.
` BY MR. SEGREST:
` Q Dr. Lane, have you been deposed
`before?
` A Yes.
` Q And how often?
` A I think it would be seven times at
`this stage.
` Q And do you remember what the matters
`were at which you were previously deposed?
` A Yes. I'm thinking chronologically the
`first case was a Lidoderm case, and it was
`against Watson. There were two other depositions
`in connection with that case, and they were for
`Hisamitsu and I think the other company was Nova.
` The next one I recall was a case for
`Auxilium against Watson again. There was a
`deposition for Galderma against Watson. There
`was a deposition for the previous nail case
`related to this case, and I think that's all that
`I recall at this point.
`
`(202) 234-4433
`
`Neal R. Gross and Co., Inc.
`Washington DC
`
`www.nealrgross.com
`FlatWing Ex. 1044, p. 5
`
`
`
`6
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`
` Q Okay. So in the first few
`depositions, were you retained by Watson?
` A No, I was retained by two -- two
`companies, Teikoku and Endo.
` Q And the Lidoderm case, was that about
`a transdermal patch?
` A It's -- it's actually more correct to
`say it's a topical patch, but it was a patch.
` Q And that was for a topical analgesic?
` A It's an analgesic. It is used to
`treat postherpetic neuralgia in patients who've
`had shingles. Actually, there's one other
`deposition I recall. There was a case -- the
`Lidoderm case came back in I think what's called
`antitrust matter. And in that case, I was
`working for Watson, Endo, and I think Teikoku
`again.
` Q And in the Caldera matter, who
`retained you?
` A In the?
` Q Caldera.
` A Galderma.
`
`(202) 234-4433
`
`Neal R. Gross and Co., Inc.
`Washington DC
`
`www.nealrgross.com
`FlatWing Ex. 1044, p. 6
`
`
`
`7
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`
` Q Galderma?
` A Galderma is the company --
` Q Okay.
` A -- they had a patent on a topical
`formulation.
` Q And in the previous nail case, that
`was when you were testifying for Anacor
`previously?
` A Yes.
` Q So you're familiar with how the
`deposition process works. But I'll just go over
`the basic guidelines for it. There's a court
`reporter here to take down everything you say.
`I'll ask questions. You will answer to the best
`of your ability. Since she's got to write down
`what we say, I'll try not to interrupt you and
`you'll try not to speak over me.
` You'll need to give verbal responses
`and a "yes" or a "no," gesturing or nodding or
`shaking your head is not something that can be
`taken down as well. If you need to take a break
`at any point, let me know and we'll take a break.
`
`(202) 234-4433
`
`Neal R. Gross and Co., Inc.
`Washington DC
`
`www.nealrgross.com
`FlatWing Ex. 1044, p. 7
`
`
`
`8
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`
`I might ask you to answer a question if it's
`pending at the time. If you don't understand a
`question, feel free to ask for clarification.
` You're under oath. It's just like a
`court proceeding. One difference is that we
`don't have a judicial officer here to rule on any
`objections that your counsel might make. So your
`counsel may make objections from time to time.
`But because there's nobody here to rule on them,
`unless counsel specifically instructs you not to
`answer, you'll need to go ahead and answer to the
`best of your ability.
` Do you have any questions about
`deposition process or how we proceed?
` A No.
` MR. MAURER: Just an administrative
`matter, Phil. But I'm not sure which caption we
`provided the court reporter with. I want to make
`sure it was the correct one for the joined
`proceedings. I believe there was an order from
`the Board that changed the caption from the
`original one.
`
`(202) 234-4433
`
`Neal R. Gross and Co., Inc.
`Washington DC
`
`www.nealrgross.com
`FlatWing Ex. 1044, p. 8
`
`
`
`9
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`
` MR. SEGREST: So this is the Notice of
`Deposition that was filed, and I believe it's
`paper number 17 in the 168 matter which is what I
`gave to the court reporter. So it doesn't have
`the paper number on there, but I'm pretty sure
`that's paper number 17 in the 168 matter. But
`that's the whole caption I think.
` MR. MAURER: I believe it is --
` MR. SEGREST: Okay.
` MR. MAURER: -- as it mentions both
`FlatWing and Mylan.
` BY MR. SEGREST:
` Q So did you submit four declarations as
`evidence in these matters?
` A Yes.
` Q I'm handing you what's Exhibit 2014 in
`the matter IPR 2018-00168, and I'm going to refer
`to these as the -00168, -00169, -00170, and -
`00171 matters.
` (Whereupon, the above-referred to
`document was marked as Petitioner's Exhibit 2014
`for identification.)
`
`(202) 234-4433
`
`Neal R. Gross and Co., Inc.
`Washington DC
`
`www.nealrgross.com
`FlatWing Ex. 1044, p. 9
`
`
`
`10
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`
` BY MR. SEGREST:
` Q Now is this the declaration you
`submitted in the -00168 matter?
` A Yes.
` Q I'm handing you what's been marked as
`Exhibit 2014 also. Is this the declaration that
`you submitted on the -00169 matter?
` A Yes, it is.
` Q Another Exhibit 2014. Is this the
`declaration you submitted on the -00170 matter?
`Did I give you two copies?
` MR. MAURER: It's just one.
` THE WITNESS: Yes, it is.
` BY MR. SEGREST:
` Q And this is the fourth exhibit, 2014.
`Is this the declaration you submitted in the -
`00171 matter?
` A Yes, it is.
` Q Other than the patent numbers and the
`specific claim language as it's referenced in
`your declarations, do you know of any other
`differences between these four declarations?
`
`(202) 234-4433
`
`Neal R. Gross and Co., Inc.
`Washington DC
`www.nealrgross.com
`FlatWing Ex. 1044, p. 10
`
`
`
`11
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`
` A No.
` Q Did you give an opinion as to
`obviousness in any of these four declarations?
` MR. MAURER: Objection to form.
` THE WITNESS: As far as I understand,
`I've not given any opinion on obviousness.
` BY MR. SEGREST:
` Q Okay. For any of the four patents
`that are covered here, right?
` A Again, I wasn't asked to give an
`opinion on obviousness.
` Q When were you retained in these four
`IPR matters?
` A I believe it was January 2018.
` Q And who contacted you about being
`retained?
` A I think it was Mr. Maurer.
` Q Are you currently retained as an
`expert witness in any other litigation or patent
`office matters?
` A Yes.
` Q There are some litigations that relate
`
`(202) 234-4433
`
`Neal R. Gross and Co., Inc.
`Washington DC
`www.nealrgross.com
`FlatWing Ex. 1044, p. 11
`
`
`
`12
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`
`to some of these same patents. Are you retained
`as an expert in those?
` A Not that I am aware of.
` Q Okay. Can you tell me what other
`matters you're retained in currently?
` A There is a case for Allergan, but I
`think that there may be a change in the case
`because of a company takeover or purchase. So
`I'm not quite sure who I'm working with over
`there.
` Q Okay. Do you know what -- does it
`relate to a particular pharmaceutical product?
` A It's a cream, a topical cream for
`acne.
` Q Do you know the brand name or the
`generic name of the active ingredient?
` A Aczone, A-C-Z-O-N-E.
` Q Are you retained in any other
`litigations at this time?
` A There -- there is another product, but
`I can't think of the name of it. It's a
`psoriasis product.
`
`(202) 234-4433
`
`Neal R. Gross and Co., Inc.
`Washington DC
`www.nealrgross.com
`FlatWing Ex. 1044, p. 12
`
`
`
`13
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`
` Q And for whom are you retained for that
`psoriasis product?
` A Galderma.
` Q Do you charge the same rate for your
`time in all of those expert witness matters?
` A I try to, yes.
` Q And what rate do you charge?
` A I think it's currently 350 English
`pounds per hour.
` Q Do you know how many hours you've
`spent on these IPR matters that you hear about
`today?
` A I could -- well, I can try and do the
`math for you. Sorry, can I have a pen?
` Q Yes.
` A I need to do some --
` Q I don't think I've got a pencil, but
`I've got a pen. And you could use this --
` A Thank you.
` Q -- for paper.
` A So I'm coming up with approximately 80
`hours.
`
`(202) 234-4433
`
`Neal R. Gross and Co., Inc.
`Washington DC
`www.nealrgross.com
`FlatWing Ex. 1044, p. 13
`
`
`
`14
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`
` MR. SEGREST: Okay and can you put a
`sticker on that as Exhibit 1046?
` (Whereupon, the above-referred to
`document was marked as Petitioner's Exhibit 1046
`for identification.)
` BY MR. SEGREST:
` Q I'm sorry. How much time did you say
`it was?
` A Eighty.
` Q And did that include that your
`preparation for the deposition today?
` A Yes.
` Q So what did you do to prepare to
`testify today?
` A So I met with counsel and I reviewed
`my reports and I reviewed the references that I
`have cited in my reports.
` Q Now, you used the word "reports". Are
`you referring to the declarations that are
`Exhibit 2014?
` A Yes, I meant my declarations.
` Q How long did you met with counsel?
`
`(202) 234-4433
`
`Neal R. Gross and Co., Inc.
`Washington DC
`www.nealrgross.com
`FlatWing Ex. 1044, p. 14
`
`
`
`15
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`
` A Over two days, approximately ten
`hours.
` (Pause.)
` BY MR. SEGREST:
` Q And you say you reviewed the materials
`cited, those are the various exhibits that are
`cited in your report?
` A Yes.
` Q And pick up your declaration from
`matter number -00168. I want to direct your
`attention to Paragraph 3. Does this indicate
`that you reviewed the petitions for inter partes
`review that were filed in these matters, the
`declarations from Dr. Kahl and Murthy and the
`exhibits and articles cited in the petition and
`declarations?
` A Yes.
` Q Now, did you also review the various
`exhibits that are cited in your declarations?
` A I believe that I did, yes.
` Q Did you review any other materials
`that aren't cited or mentioned here?
`
`(202) 234-4433
`
`Neal R. Gross and Co., Inc.
`Washington DC
`www.nealrgross.com
`FlatWing Ex. 1044, p. 15
`
`
`
`16
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`
` A Not that I recall.
` Q Did you review any of the materials
`from the previous IPRs other than what's cited in
`here?
` A I looked at my deposition from the
`previous case.
` Q Did you look at the final written
`decision from the previous IPRs?
` A I looked at it but not for some time.
` Q When did you look at it?
` A I think when I met with counsel
`earlier this year.
` Q Did you refer to that decision when
`you were preparing your declaration?
` A I focused on the specific matters that
`I've talked about here. So I don't believe that
`I did.
` (Pause.)
` BY MR. SEGREST:
` Q Now, how did you select the materials
`that are cited in your declaration?
` A Should I go through every --
`
`(202) 234-4433
`
`Neal R. Gross and Co., Inc.
`Washington DC
`www.nealrgross.com
`FlatWing Ex. 1044, p. 16
`
`
`
`17
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`
` Q No, in general, did you do a search or
`investigation yourself? Were these materials
`provided to you by someone?
` A As far as I recall, I'm familiar with
`a lot of these materials. And I think that I
`would have maybe just checked to see if there's
`anything new in the field. So I don't recall
`specifically looking for extra material.
` Q Okay. Did you suggest other materials
`that are cited or were some of the materials
`suggested to you?
` MR. MAURER: Object to the form of the
`question.
` THE WITNESS: Well --
` MR. MAURER: As I understand the rules
`for these proceedings, communications with
`counsel for drafting the report are confidential.
`So I'm going to object on that ground.
` BY MR. SEGREST:
` Q Okay. So without revealing
`conversations with counsel, if you can answer my
`question which was whether you identified the
`
`(202) 234-4433
`
`Neal R. Gross and Co., Inc.
`Washington DC
`www.nealrgross.com
`FlatWing Ex. 1044, p. 17
`
`
`
`18
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`
`materials or whether the materials were suggested
`to you. If you can answer that without telling
`me conversations with counsel.
` MR. MAURER: So I'm going to object.
`I'm going to instruct you not to refer to any
`communications with counsel. If you can answer
`that question without doing so, you may do so.
` THE WITNESS: Okay, yes. I believe I
`would have suggested references.
` BY MR. SEGREST:
` Q Okay. Still in this same declaration,
`I'm going to stick with this one unless we need
`to refer to the claim language. Is Paragraph 5 a
`reservation of rights?
` A I understand Paragraph 5 is written
`from a lawyer's perspective -- a legal
`perspective.
` Q Do you have any understanding of what
`right you might have to expand or otherwise
`modify opinions or conclusions independent of
`what's said here?
` A So I did review the paragraph, and I
`
`(202) 234-4433
`
`Neal R. Gross and Co., Inc.
`Washington DC
`www.nealrgross.com
`FlatWing Ex. 1044, p. 18
`
`
`
`19
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`
`understood it to be that if other information had
`to be considered that it could be included after
`I had written this.
` Q Did you have some understanding about
`the mechanism for doing that, or is that
`something that you'd rely on attorneys for?
` A I think that as I read it and I had
`prepared reports in other cases and my
`understanding -- but once again, I'm not a lawyer
`-- is that it allows you to add to it if you feel
`that it should be added.
` Q So your understanding of this was in
`comparison to expert reports that you prepared in
`those other federal litigations, is that correct?
` A This is -- this is a case that is
`unusual for me because clearly it's not something
`that I have a lot of experience of. So as I
`explained, that's how I understood it to be, that
`it would allow me to add additional material
`should I receive advice from counsel that it was
`important to do that.
` Q Okay. And my next question, you may
`
`(202) 234-4433
`
`Neal R. Gross and Co., Inc.
`Washington DC
`www.nealrgross.com
`FlatWing Ex. 1044, p. 19
`
`
`
`20
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`
`not have an understanding of this. My question
`really is, do you have any understanding of the
`difference between your direct testimony in a
`declaration, in an inter partes review
`proceeding, and an expert report that you
`prepared in federal district court litigation?
` A I don't understand all the
`differences. I think I would have to say that.
` Q Okay. Well, do you understand any of
`the differences? You said you don't understand
`all the differences.
` A I think that clearly the matter is
`perceived differently and a different examination
`of the materials I submit takes place. There
`isn't a court trial as such.
` Q Now, referring back to Paragraph 4 in
`this same declaration, the second sentence, does
`this indicate that you're aware of knowledge
`generally available to and relied upon by persons
`of ordinary skill in the art at the time of the
`invention?
` A That's what I have written there.
`
`(202) 234-4433
`
`Neal R. Gross and Co., Inc.
`Washington DC
`www.nealrgross.com
`FlatWing Ex. 1044, p. 20
`
`
`
`21
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`
` Q And referring to Paragraph 12, it is
`your testimony there that you consider yourself
`qualified to provide opinions on the
`understanding of a person of ordinary skill in
`the relevant art in 2005 as it pertains to
`parameters relating to transungual penetration
`and the identification of potential drug
`candidates for transungual penetration?
` A Yes.
` Q Anywhere in your testimony do you say
`what the level of ordinary skill in the art is?
` A My understanding was that there was a
`definition of what the POSA was. And I consider
`that I have the qualifications to comment on what
`that POSA would have known about transungual
`penetration and identification of drug candidates
`or transungual penetration.
` Q And what's your understanding of the
`definition of a POSA in this matter?
` A What I understand is that the
`definition that has been used is a person with a
`master's or PhD in chemistry, pharmacology,
`
`(202) 234-4433
`
`Neal R. Gross and Co., Inc.
`Washington DC
`www.nealrgross.com
`FlatWing Ex. 1044, p. 21
`
`
`
`22
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`
`pharmaceutical sciences and with at least two
`years of formulated pharmaceutical products.
` Q Okay. So in Paragraphs 4 and 12, is
`that what you're referring to as a POSA?
` A Yes.
` Q I want to direct you to Paragraph 6 in
`your declaration. It's under the heading,
`academic and professional qualification. Now
`among other things in your background, does this
`indicate that your PhD research included amount
`matters a focus on mathematical modeling of
`topical and transdermal drug delivery and
`prediction of percutaneous drug penetration?
` A Yes.
` Q Now, how would those mathematical
`models and predictions used?
` A For skin? For skin? How are the
`mathematical models used for skin? Is that the
`question?
` Q I'm sorry. I didn't understand what
`you were asking.
` A So I think your question was, how are
`
`(202) 234-4433
`
`Neal R. Gross and Co., Inc.
`Washington DC
`www.nealrgross.com
`FlatWing Ex. 1044, p. 22
`
`
`
`23
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`
`those mathematical models used? And I'm just
`asking you, are you specifically asking me about
`topical and transdermal drug delivery.
` Q Yes.
` A Okay. So in the 1990s, there was
`still a lot of developmental work in topical and
`transdermal delivery. And efforts were made to
`try and understand how we could gain a better
`insight into what drugs might be suitable for
`topical and transdermal drug delivery.
` Q What do you mean by developmental
`work?
` A The delivery of drugs to the skin is
`more challenging than other routes of drug
`delivery. And at the time, we didn't have a
`complete understanding of how we would identify
`candidates. So developmental work involves
`feasibility assessment of candidates and to see
`if they can be delivered. And then if you build
`up a knowledge of different properties, there
`were attempts to arrive at models which would
`attempt to tell you if you could get the
`
`(202) 234-4433
`
`Neal R. Gross and Co., Inc.
`Washington DC
`www.nealrgross.com
`FlatWing Ex. 1044, p. 23
`
`
`
`24
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`
`particular compound or other compounds into the
`skin or through the skin.
` Q So if you were able to identify a
`candidate compound through this method, what
`would be the next step in developing it?
` MR. MAURER: Objection. Scope.
` THE WITNESS: Well, I'm not sure that
`that's an easy question to answer because, as I
`said, the first thing you would have to do is a
`feasibility assessment and this is with skin that
`I'm referring to here. And the work I did was in
`conjunction with a pharmaceutical company. So
`there were other units in the company and there
`wasn't just me as an academic. So based on the
`data that I would generate, there would then be
`feedback from other units about what the next
`stages would be.
` BY MR. SEGREST:
` Q Could the next stages include
`preclinical and clinical trials?
` A In my case, it didn't include it but
`it would've involved -- formulation was my
`
`(202) 234-4433
`
`Neal R. Gross and Co., Inc.
`Washington DC
`www.nealrgross.com
`FlatWing Ex. 1044, p. 24
`
`
`
`25
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`
`expertise. So it would've involved evaluation or
`decisions about formulation choices to make.
` Q Were any of those formulations that
`you were involved in developed into products that
`were commercially marketed?
` A No.
` Q If a product were going to be
`commercially marketed, would it have to go
`through clinical trials first?
` MR. MAURER: Objection. Scope.
` THE WITNESS: I believe that it would.
` BY MR. SEGREST:
` Q Have you ever been involved in
`clinical trials?
` A Not in conducting clinical trials but
`in assessing clinical trial data.
` Q And what would you do in assessing
`clinical trial data?
` A It would depend on what particular
`data set I'm looking at.
` Q How often have you done that?
` A It depends on the particular project
`
`(202) 234-4433
`
`Neal R. Gross and Co., Inc.
`Washington DC
`www.nealrgross.com
`FlatWing Ex. 1044, p. 25
`
`
`
`26
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`
`I'm working on. I have a small consultancy
`company and there are a number of companies that
`would show me data. So it's hard to give you an
`exact number. But over the years, I have been
`involved in five or six projects that require
`assessment of data from clinical trials.
` Q Were any of those clinical trials
`dose-ranging studies?
` A I think that one ibuprofen study was.
` Q And as far as you know, were dose-
`ranging studies a common part of the clinical
`trials that are involved in drug approval?
` A That's a very general question and
`what I would say is, based on some of the
`projects that I'm involved in, there would be a
`discussion about what doses should be looked at.
` Q Would there then be testing of those
`doses or dosing regimens for safety and efficacy?
` MR. MAURER: Objection. Scope.
` THE WITNESS: Again, based on projects
`I've been involved in, safety and efficacy and
`dosing would all be areas that companies would
`
`(202) 234-4433
`
`Neal R. Gross and Co., Inc.
`Washington DC
`www.nealrgross.com
`FlatWing Ex. 1044, p. 26
`
`
`
`27
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`
`concern themselves with.
` BY MR. SEGREST:
` Q So referring to Paragraph 1, for the
`'938 patent, are you opining on only claims 3, 5,
`and 6?
` A I'd just need to check in the report,
`please.
` Q It's Paragraph 1.
` A Thank you. So in this report, I'm
`addressing claims 3, 5, and 6. And I understand
`that they are dependent on claim 1. And yes,
`that's correct.
` Q And just for the '938 patent, right?
` A As far as I see here, claim 1, 3, 5,
`and 6 of the '938 patent is what I'm discussing
`in this report.
` Q You mentioned that claim 1 -- the
`other claims depend from claim 1. But claim 1 is
`not separately recited in Paragraph 1, right?
` A Yes, it's not separately recited.
` Q So does this report contain opinions
`as to the validity of only claims 3, 5, and 6 as
`
`(202) 234-4433
`
`Neal R. Gross and Co., Inc.
`Washington DC
`www.nealrgross.com
`FlatWing Ex. 1044, p. 27
`
`
`
`28
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`
`they depend from claim 1 but not the validity of
`claim 1 itself?
` A Well, my understanding is that I'm
`talking about all the claims and the validity of
`all the claims.
` Q So you say all the claims. You mean
`--
` A Sorry.
` Q -- every claim of the '938 patent?
` A I'm sorry. I didn't word that
`carefully. I'm referring to Paragraph 16, 1, 3,
`5, and 6.
` Q Which paragraph are you referring to?
` A Paragraph 16.
` Let me direct you to Paragraph 67.
`And in Paragraph 67, you indicate that claims 3,
`5, and 6 of the '938 patent recite a
`pharmaceutical composition in the form of a
`solution comprising five percent w/w of
`tavaborole?
` A Yes.
` Q Turning back to Paragraph 17, does
`
`(202) 234-4433
`
`Neal R. Gross and Co., Inc.
`Washington DC
`www.nealrgross.com
`FlatWing Ex. 1044, p. 28
`
`
`
`29
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`
`claim 1 include that limitation about five
`percent of tavaborole?
` A Those words aren't in claim 1.
` Q Are those words in claims 3, 5, and 6?
` A The words are in claims 3 and 5. And
`I think in claim 6 which is referring back to the
`five percent preparation, it's explained that
`there are two components in the pharmaceutical
`composition in claim 3 and in claim 5.
` Q Okay. So the five percent language
`appears in claims 3 and 5, right?
` A It appears in claims 3 and 5, but I
`understand that it's also meant in claim 6.
` Q Okay. But it's not in claim 1, right?
` A As we read claim 1, we see that it
`talks about a method. But the specific words
`that we have looked at, five percent tavaborole,
`are not called out in claim 1.
` Q So in Paragraph 1 where it says that
`your declaration contains your opinions related
`to the validity of claims 3, 5, and 6. Is that
`because only claims 3, 5, and 6 include or
`
`(202) 234-4433
`
`Neal R. Gross and Co., Inc.
`Washington DC
`www.nealrgross.com
`FlatWing Ex. 1044, p. 29
`
`
`
`30
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`
`incorporate that five percent language?
` A In my report or in my declaration, I
`was asked to focus on five percent tavaborole.
`So it's important to refer to those claims.
` Q Let's look at your declaration on
`matter -00169 on the '289 matter for a moment.
`I'm directing you to Paragraph 1. Does this
`paragraph indicate that the declaration contains
`your opinions related to the validity of claims
`10, 12 through 15 -- I'm sorry, 10 and 12 through
`15 of the '289 patent?
` A As well as that paragraph, I would
`just like to refer to where I talk about the
`claims.
` Q That's Paragraph 16 you're saying?
` A Yes, thank you. So in looking at the
`claims, I noted that claim 10 also depends on
`claim 4. And then claim 4 is further discussed
`in the next paragraph as is claim 10. And then
`claims 13 to 15 also depend directly or
`indirectly on independent claim 12 and
`incorporate all limitations of the claims from
`
`(202) 234-4433
`
`Neal R. Gross and Co., Inc.
`Washington DC
`www.nealrgross.com
`FlatWing Ex. 1044, p. 30
`
`
`
`31
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`
`which they depend. And then I go on to discuss
`claim 13, claim 14, and claim 15.
` Q Okay. Would you like to take a short
`break to get a drink of water or something?
` A I -- I -- I don't mind. My voice is
`a little bit hoarse at the moment.
` Q Okay. We can take a break whenever
`you need to.
` MR. MAURER: Why don't we actually
`take a break.
` MR. SEGREST: Okay. That's fine.
` (Whereupon, the above-entitled matter
`went off the record at 11:05 a.m. and resumed at
`11:11 a.m.)
` BY MR. SEGREST:
` Q Okay. I believe when we left off, you
`were indicating -- so you were indicating that
`claims 10 and 12 through 15 all depend, directly
`or indirectly, from independent claim 1?
` A I thought that --
` Q I mean, sorry, independent claim 4.
`I misspoke.
`
`(202) 234-4433
`
`Neal R. Gross and Co., Inc.
`Washington DC
`www.nealrgross.com
`FlatWing Ex. 1044, p. 31
`
`
`
`32
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`
` A I'll just check these. So starting on
`Paragraph 16, that claim 10 depends from
`independent claim 4 and therefore incorporates
`all limitations of independent claim 4. And then
`on the next page, I go on to state what claim 4
`recites and then claim 10. And then I go on to
`claim 13 to 15. I do, in Paragraph 19, note that
`claims 13 to 15 depend directly or indirectly on
`independent claim 12. And then the next
`paragraph talks about claim 12. Paragraph 21
`discusses claim 13, and Paragraph 22 and 23
`discuss claim 14 and 15.
` Q Right. So I was incorrect. There are
`two independent claims here, right? There's
`independent claim 4 and independent claim 12,
`right?
` A That's what is stated in the
`declaration.
` Q And does independent claim 12 include
`a limitation of about five percent w/w of
`tavaborole?
` A Yes.
`
`(202) 234-4433
`
`Neal R. Gross and Co., Inc.
`Washington DC
`www.nealrgross.com
`FlatWing
Accessing this document will incur an additional charge of $.
After purchase, you can access this document again without charge.
Accept $ Charge
Still Working On It
This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.
Give it another minute or two to complete, and then try the refresh button.
A few More Minutes ... Still Working
It can take up to 5 minutes for us to download a document if the court servers are running slowly.
Thank you for your continued patience.
This document could not be displayed.
We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.
Your account does not support viewing this document.
You need a Paid Account to view this document. Click here to change your account type.
Your account does not support viewing this document.
Set your membership
status to view this document.
With a Docket Alarm membership, you'll
get a whole lot more, including:
- Up-to-date information for this case.
- Email alerts whenever there is an update.
- Full text search for other cases.
- Get email alerts whenever a new case matches your search.
One Moment Please
The filing “” is large (MB) and is being downloaded.
Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.
Your document is on its way!
If you do not receive the document in five minutes, contact support at support@docketalarm.com.
Sealed Document
We are unable to display this document, it may be under a court ordered seal.
If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.
Access Government Site
