`
` UNITED STATES PATENT AND TRADEMARK OFFICE
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`MYLAN PHARMACEUTICALS INC. *
`and AMNEAL PHARMACEUTICALS *
`LLC, *
` * Case No. IPR2015-00643
` Petitioners, * (8,232,250 B2)
` *
`VS. * Case No. IPR2015-00644
` * (8,399,413 B2)
`YEDA RESEARCH AND *
`DEVELOPMENT CO. LTD., * Case No. IPR2015-00830
` * (8,969,302 B2)
` Patent Owner. *
`
` *******************************************
` ORAL AND VIDEOTAPED DEPOSITION OF
` EDWARD J. FOX, MD
` JANUARY 26, 2016
` *******************************************
`
` ORAL AND VIDEOTAPED DEPOSITION OF EDWARD
`J. FOX, MD, produced as a witness at the instance of
`the Petitioner Mylan Pharmaceuticals Inc. and duly
`sworn, was taken in the above-styled and numbered cause
`on the 26th day of January, 2016, from 9:22 a.m. to
`4:30 p.m., before Marsha Yarberry, Certified Shorthand
`Reporter in and for the State of Texas, reported by
`machine shorthand, at the offices of Wilson Sonsini
`Goodrich & Rosati, 900 South Capital of Texas Highway,
`Las Cimas IV, 5th Floor, Austin, Texas.
`
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`YEDA EXHIBIT NO. 2146
`MYLAN PHARM. v YEDA
`IPR2015-00644
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`
`
` APPEARANCES
`
`Page 2
`
`FOR THE PETITIONER MYLAN PHARMACEUTICALS INC.:
`
` MR. DAVID L. ANSTAETT
` Perkins Coie
` One East Main Street, Suite 201
` Madison, Wisconsin 53703-5118
` 608-663-5408
` DAnstaett@perkinscoie.com
` --and--
` MS. COURTNEY M. PROCHNOW
` Perkins Coie
` 1888 Century Park East, Suite 1700
` Los Angeles, California 90067-1721
` 310-788-3284
` CProchnow@perkinscoie.com
`
` --and--
`
` MS. SHANNON BLOODWORTH (Via Telephone)
` MR. ROBERT SWANSON (Via Telephone)
` Perkins Coie
` 700 13th Street, NW, Suite 600
` Washington, DC 20005-3960
` 202-654-6200
` --and--
` MS. LORELEI P. WESTIN
` Wilson Sonsini Goodrich & Rosati
` 12235 El Camino Real, Suite 200
` San Diego, California 92130
` 858-350-2300
` lwestin@wsgr.com
`
` Veritext Legal Solutions
` Mid-Atlantic Region
` 1250 Eye Street NW - Suite 1201
` Washington, D.C. 20005
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`YEDA EXHIBIT NO. 2146
`MYLAN PHARM. v YEDA
`IPR2015-00644
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` APPEARANCES (cont'd)
`
`FOR THE PETITIONER AMNEAL PHARMACEUTICALS LLC:
`
` MR. VINCENT L. CAPUANO
` Duane Morris LLP
` 100 High Street, Suite 2400
` Boston, Massachusetts 02110-1724
` 857-488-4250
` vcapuano@duanemorris.com
`
`FOR THE PATENT OWNER:
`
` MR. JOHN T. BENNETT
` Goodwin Procter
` Exchange Place
` Boston, Massachusetts 02109
` 617-570-1000
` jbennett@goodwinprocter.com
` --and--
` MR. ANDREW E. RILEY
` Goodwin Procter
` The New York Times Building
` 620 8th Avenue
` New York, New York 10018-1405
` 212-813-8800
` ariley@goodwinprocter.com
`
`ALSO PRESENT:
`
` Mr. Matthew Greinert, Mylan in-house counsel
` Ms. Lori Wolfe, Teva in-house counsel
` Mr. Jason Lemley, Videographer
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`YEDA EXHIBIT NO. 2146
`MYLAN PHARM. v YEDA
`IPR2015-00644
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`Page 4
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` INDEX
` PAGE
`
`Appearances..................................... 2
`
`EDWARD J. FOX, MD
` Examination by Mr. Anstaett................. 7
` Examination by Mr. Bennett.................. 211
` Further Examination by Mr. Anstaett......... 213
`Changes and Corrections......................... 215
`Signature....................................... 216
`Reporter's Certificate.......................... 217
`
` EXHIBITS
`
`NO. DESCRIPTION PAGE/LINE REFERENCED
`
`Exhibit 1005.................................... 192/15
` PCT application
`Exhibit 1006.................................... 131/8
` Article titled Randomized, Double-Blind,
` Dose-Comparison Study of Glatiramer Acetate
` in Relapsing-Remitting MS
`
`Exhibit 1008.................................... 43/13
` Article titled Copolymer 1 (Glatiramer
` Acetate) in Relapsing Forms of Multiple
` Sclerosis: Open Multicenter Study of
` Alternate-Day Administration
`
`Exhibit 1010.................................... 27/1
` Study by Dr. Omar Khan
`Exhibit 1011.................................... 41/25
` Study comparing daily injections of
` 20 milligrams of glatiramer acetate with
` every-other-day 20-milligram glatiramer
` acetate injections
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`YEDA EXHIBIT NO. 2146
`MYLAN PHARM. v YEDA
`IPR2015-00644
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`Page 5
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` EXHIBITS (cont'd)
`
`NO. DESCRIPTION PAGE/LINE REFERENCED
`
`Exhibit 1067.................................... 9/10
` Petitioners' Notice of Deposition of
` Dr. Edward J. Fox
`Exhibit 1068.................................... 86/14
` Abstract
`
`Exhibit 1069.................................... 102/4
` Abstract
`Exhibit 1070.................................... 123/22
` Article titled Glatiramer Acetate:
` Successful Desensitization For Treatment of
` Multiple Sclerosis
`
`Exhibit 1071.................................... 151/6
` Article titled Gray Matter Atrophy in
` Multiple Sclerosis: A Longitudinal Study
`
`Exhibit 1072.................................... 161/3
` Fourth Declaration of Edward J. Fox, M.D.,
` PH.D.
`
`Exhibit 1073.................................... 181/2
` Article titled Tolerability and Safety of
` Novel Half Milliliter Formulation of
` Glatiramer Acetate For Subcutaneous
` Injection: An Open-Label Multicenter,
` Randomized Comparative Study
`Exhibit 1074.................................... 203/11
` Article titled Exorbitant Drug Costs May
` Price Out Patients
`Exhibit 2028.................................... 135/10
` Slide presentation
`
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`YEDA EXHIBIT NO. 2146
`MYLAN PHARM. v YEDA
`IPR2015-00644
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`Page 6
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` EXHIBITS (cont'd)
`
`NO. DESCRIPTION PAGE/LINE REFERENCED
`
`Exhibit 2029.................................... 59/22
` Article titled GLACIER: An Open-Label,
` Randomized, Multicenter Study to Assess the
` Safety and Tolerability of Glatiramer
` Acetate 40 mg Three Times Weekly Versus 20 mg
` Daily in Patients with Relapsing-Remitting
` Multiple Sclerosis
`Exhibit 2054.................................... 96/19
` Shalit abstract
`
`Exhibit 2091.................................... 121/11
` Katz abstract
`Exhibit 2093.................................... 114/20
` Article titled Rapid Desensitization For
` Hypersensitivity Reactions to Medications
`Exhibit 2095.................................... 110/13
` Article titled Responsiveness of Human Skin
` Mast Cells to Repeated Activation: An In
` Vitro Study
`
`Exhibit 2100.................................... 194/4
` Curriculum Vitae
`Exhibit 2129.................................... 12/4
` Declarations of Edward J. Fox, M.D., Ph.D. in
` Support of Patent Owner Yeda's Response to
` Institution of Inter Partes Review
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`YEDA EXHIBIT NO. 2146
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`IPR2015-00644
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` THE VIDEOGRAPHER: Good morning. We are
`
`on the record at 9:22 a.m. on January 26, 2016. This
`
`is the video recorded deposition of Dr. Edward Fox. My
`
`name is Jason Lemley, here with our court reporter,
`
`Marsha Yarberry. We are here from Veritext Legal
`
`Solutions at the request of counsel for the plaintiff.
`
` This deposition is being held at 900
`
`South Capital of Texas Highway in Austin, Texas. The
`
`caption of this case is Mylan Pharmaceuticals Inc.
`
`versus Yeda Research and Development Company Ltd.
`
` At this time will counsel and all present
`
`identify themselves for the record?
`
` MR. ANSTAETT: This is David Anstaett of
`
`Perkins Coie on behalf of Mylan, and we have several
`
`people here as well, and I'm going to let them make
`
`their own introductions.
`
` MS. PROCHNOW: Courtney Prochnow from
`
`Perkins Coie on behalf of Mylan.
`
` MS. WESTIN: Lori Westin, Wilson Sonsini
`
`Goodrich & Rosati on behalf of Mylan.
`
` MR. GREINERT: Matthew Greinert
`
`representing Mylan.
`
` MR. CAPUANO: Vincent Capuano with Duane
`
`Morris on behalf of Petitioner Amneal.
`
` MR. BENNETT: John Bennett, Goodwin
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`YEDA EXHIBIT NO. 2146
`MYLAN PHARM. v YEDA
`IPR2015-00644
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`Procter, Boston, representing the patent owner. With
`
`me is my colleague, Andy Riley, and we also have
`
`Lori Wolfe, counsel from Teva Pharmaceuticals.
`
` THE VIDEOGRAPHER: Thank you. The
`
`witness will be sworn in and counsel may begin the
`
`examination.
`
` (Witness sworn)
`
` MR. BENNETT: Before we begin, David, I'm
`
`going to lodge an objection to the presence of the
`
`videographer. Petitioners should have filed a motion
`
`for permission to video the deposition. There was no
`
`agreement between the parties that video would occur,
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`and in our view the presence of the videographer is
`
`objectionable. We will reserve all rights to oppose
`
`any entry of a video record onto the record should
`
`Mylan decide to later do so. That being said, we are
`
`going to go ahead and proceed subject to my objection
`
`today.
`
` MR. ANSTAETT: Okay. And I understand
`
`the objection. Our understanding of the requirements
`
`of 37 CFR 42.53(a) are different than those you just
`
`articulated. We do understand that to submit a
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`videotape to the Board we would need to move for
`
`permission to do that, and I will note for the record
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`and I'm going to mark as an exhibit just so it is in
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`YEDA EXHIBIT NO. 2146
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`IPR2015-00644
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`record the deposition notice that was served for
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`Dr. Fox which specifically noted that the testimony
`
`would be recorded by stenographic and videographic
`
`means, and we received no objection from patent owner
`
`to the deposition notice. But with that understanding,
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`I think we can proceed.
`
` And let me give Madam Court Reporter a
`
`copy of the deposition notice so we can mark that as an
`
`exhibit.
`
` (Exhibit 1067 marked)
`
` MR. ANSTAETT: Do you want a copy of
`
`that, John? Or --
`
` MR. BENNETT: That's fine.
`
` EDWARD J. FOX, MD,
`
`having been first duly sworn, testified as follows:
`
` EXAMINATION
`
`QUESTIONS BY MR. ANSTAETT:
`
` Q. Good morning, Dr. Fox.
`
` A. Good morning.
`
` Q. I'm going to ask you to please state and spell
`
`your name for the record.
`
` A. First name Edward, E-d-w-a-r-d, middle initial
`
`J, last name Fox, F-o-x, MD, PhD.
`
` Q. Dr. Fox, have you ever had your deposition
`
`taken before?
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`YEDA EXHIBIT NO. 2146
`MYLAN PHARM. v YEDA
`IPR2015-00644
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` A. I have.
`
` Q. How many times?
`
` A. Approximately five.
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` Q. Can you tell me in chronological order what
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`those depositions involved to the best of your
`
`recollection?
`
` A. I have been a fact witness in several personal
`
`injury cases, and I have given one instance of expert
`
`testimony, again in a malpractice case.
`
` Q. Okay. But the -- so the expert testimony was
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`in the context of a malpractice case?
`
` A. Correct.
`
` Q. Okay. Have you ever served as an expert in a
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`patent litigation?
`
` A. I have not.
`
` Q. Okay. The medical malpractice case that you
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`served as an expert in, did that involve multiple
`
`sclerosis?
`
` A. No, it did not.
`
` Q. Okay. What did it involve?
`
` A. It involved a postoperative injury that was
`
`immune in nature.
`
` Q. Okay. Do you recall when that testimony was
`
`given? Just the expert testimony.
`
` A. It may have been ten years ago.
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`YEDA EXHIBIT NO. 2146
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` Q. Okay. Okay. I want to -- you've been through
`
`this before, so you probably know the drill, but I do
`
`want to remind you that you're under oath, so the
`
`testimony you give today has the same force and effect
`
`as if it were given in a court of law. If you don't
`
`understand a question that I ask today, please stop me
`
`and ask me to explain and I'll do my best to do so.
`
` Your counsel may object to questions that
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`I ask from time to time, which he's perfectly entitled
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`to do, but notwithstanding that, unless he instructs
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`you not to answer the question, you may go ahead and
`
`answer the question. It's important that we try not to
`
`talk over one another today because it makes the court
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`reporter's life very difficult if we do that, so I'll
`
`do my best not to interrupt any answer you're giving,
`
`and if you'll just let me complete my questions, that
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`will make everybody's life easier.
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` And if you want to take a break at any
`
`point, just let me know. I just ask you to answer any
`
`question that's pending at the time. But please feel
`
`free if you need to take a break to just let me know.
`
`Okay?
`
` A. Yes.
`
` Q. Sound good?
`
` A. Yes.
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` Q. All right. Let me do some kind of
`
`housekeeping here first. I'm going to give you some
`
`exhibits which I think you'll recognize. The first one
`
`is Exhibit 2129 in IPR2015-643, which relates to Patent
`
`No. 8,232,250. Let me hand that to you.
`
` MR. BENNETT: David, if you could just
`
`give me a copy.
`
` MR. ANSTAETT: Oh, yeah. Sorry, John.
`
` Q. (By Mr. Anstaett) The second exhibit I'm
`
`going to hand you is also Exhibit No. 2129, but that is
`
`in IPR2015-00644, which relates to U.S. Patent No.
`
`8,399,413. And the third I'm handing you is also
`
`Exhibit No. 2129. This is in IPR No. 2015-00 -- it
`
`says on the cover 6830. I believe it's 830. And that
`
`relates to Patent No. 8,969,302.
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` And what I would like you to do is -- and
`
`please feel free to take all the time you need. Just
`
`look through those. These are your declarations in
`
`the -- in the three IPRs, and just if you could look
`
`through those and verify that they are indeed your
`
`declarations, I would appreciate that.
`
` A. Yes, I agree that these are the documents.
`
` Q. Okay. Thank you. As I ask you questions
`
`today I'll generally be referring to the first of those
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`documents, which is the declaration that relates to
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`U.S. Patent No. 8,232,250, which I'll call the '250
`
`patent I'm sure from time to time, but if you -- in
`
`answering any question, if you want to look through any
`
`of the other declarations, please feel free to do so.
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`And with that, let me ask you in the '250 declaration
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`to turn to paragraph 14.
`
` A. Yes, sir.
`
` Q. In paragraph 14 you describe the person of
`
`ordinary skill in the art; is that correct?
`
` A. It is correct.
`
` Q. All right. And you say in paragraph 14 that a
`
`person of ordinary skill in the art would have
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`knowledge and experience of the pathophysiology of
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`multiple sclerosis. What do you mean by
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`pathophysiology?
`
` A. Pathology is the damage that takes place
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`within the organ systems within the human body in the
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`case of multiple sclerosis.
`
` Q. And so that's -- when you use pathophysiology,
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`that's kind of the definition that I should understand.
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`Is that fair to say? Is there any other component to
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`that, or is it just person of ordinary skill in the art
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`would have an understanding of the kind of damage that
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`takes place as a result of multiple sclerosis?
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` MR. BENNETT: Objection to the form.
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` THE WITNESS: I would agree that a person
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`of ordinary skill in the art would understand the
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`nature of the disease to the extent that damage is
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`occurring to the central nervous system and to the body
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`as a whole in multiple sclerosis.
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` Q. (By Mr. Anstaett) Okay. All right. Fair
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`enough. Okay. If you'd turn to paragraphs 34 and 35
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`of your declaration. You acknowledge, I think, in
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`those paragraphs that as of 2009 it was well-known that
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`some patients had difficulty with daily injections of
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`glatiramer acetate as a result of pain and other
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`symptoms associated with injection site reactions,
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`correct?
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` MR. BENNETT: Objection to form.
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` THE WITNESS: If you're referring to the
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`statement, "Understandably, many patients had
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`difficulty with daily injections," that's the
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`terminology that I used in my declaration.
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` Q. (By Mr. Anstaett) Right. And that's -- you
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`agree with that some -- it was known in the art in 2009
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`that patients had difficulty with daily injections of
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`glatiramer acetate, correct?
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` A. I would not use the words you've used.
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` Q. What words would you use?
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` A. Many patients. You said patients. I would
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`say many patients.
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` Q. Fair enough. Many patients. It was
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`well-known in the art in 2009 that many patients taking
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`daily injections of glatiramer acetate had difficulty
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`with those injections, correct?
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` A. Correct.
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` Q. And that that was -- further perhaps other
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`reasons, but certainly one of the reasons was because
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`of injection site reactions?
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` MR. BENNETT: Objection to the form.
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` THE WITNESS: Injection site reactions as
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`defined here was an aspect of the difficulty with the
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`administration of the drug.
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` Q. (By Mr. Anstaett) Okay. And you would agree
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`that skilled artisans in 2009 knew that daily dosing of
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`glatiramer acetate posed challenges from a patient
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`tolerability perspective. Is that fair to say?
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` A. I would disagree with the wording of that.
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` Q. How so?
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` A. Can you restate the question?
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` Q. Would it help if I said many patients? Would
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`you agree that it was known in the art in 2009 that
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`daily dosing of glatiramer acetate posed challenges for
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`many patients from a tolerability perspective?
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` MR. BENNETT: Objection to the form.
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` THE WITNESS: Dosing of injections at all
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`were an issue with the administration of the medicine.
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` Q. (By Mr. Anstaett) Of glatiramer acetate?
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` A. Yes.
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` Q. And they were a tolerability issue for
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`patients, correct?
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` A. Injections are a tolerability issue.
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` Q. Okay. And you'd also agree that skilled
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`artisans in 2009 knew that daily dosing of glatiramer
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`acetate posed challenges from a patient compliance
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`perspective. Is that fair to say?
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` A. Again, that's not the wording that I used.
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` Q. Well, how would you word it?
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` A. The dosing of the medication itself had
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`implications in terms of the tolerability of the
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`medication.
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` Q. Correct. And that's because it was dosed as a
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`daily subcutaneous injection, correct?
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` MR. BENNETT: Objection.
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` THE WITNESS: The patients that were
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`using glatiramer acetate 20 milligrams daily had
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`issues with injections. All injectable medicines have
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`issues.
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` Q. (By Mr. Anstaett) And glatiramer acetate is
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`no exception in that regard?
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` A. Correct.
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` Q. And that was known by skilled artisans in
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`Page 17
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`2009?
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` A. That is correct.
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` Q. All right. And those same issues with daily
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`subcutaneous injections also posed compliance problems
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`with patients on glatiramer acetate, correct?
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` A. All medicines have compliance issues.
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` Q. Right. But glatiramer acetate, daily
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`subcutaneous injections had patient compliance issues
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`and skilled artisans knew that in 2009, correct?
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` MR. BENNETT: Objection to the form.
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` THE WITNESS: All patients on injectable
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`medicines, including glatiramer acetate 20 milligrams
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`daily, had issues with regards to adherence.
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` Q. (By Mr. Anstaett) And how would you define
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`adherence?
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` A. Adherence is a very complicated term. There
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`have been many definitions given to it. Do you want a
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`specific definition as given by a specific agency?
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` Q. I'd like to know what you mean by adherence in
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`the context of daily 20-milligram injections of
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`glatiramer acetate and the problems they posed with
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`adherence.
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` A. Adherence is keeping to a schedule that had
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`been defined ahead of time, and a lack of adherence can
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`be in many different forms but is expected to be less
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`than adequate dosing of a medication.
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` Q. All right. And that was a known problem in
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`the art with daily 20-milligram injections of
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`glatiramer acetate in 2009, correct?
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` MR. BENNETT: Objection.
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` THE WITNESS: I think I need you to
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`restate that question because it was overly broad for
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`me to say whether this was a specific problem to
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`glatiramer acetate.
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` Q. (By Mr. Anstaett) I'm asking you if it was a
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`problem that was known in the art with glatiramer
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`acetate in 2009. You're free to tell me if you think
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`it was a problem with other medicines as well, but
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`certainly I think we can agree that daily dosing of
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`20 milligrams of glatiramer acetate in 2009 was known
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`by skilled artisans to cause adherence problems as
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`you've defined that.
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` A. What I agree with was that dosing of
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`glatiramer acetate as of 2009 had issues with regards
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`to adherence.
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` Q. All right. And skilled artisans knew that in
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`2009?
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` A. Agreed.
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` Q. Okay. Those issues with tolerability and
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`adherence motivated skilled artisans in 2009 to explore
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`dosing regimens for glatiramer acetate that were less
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`frequent than daily dosing, correct?
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` MR. BENNETT: Objection.
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` THE WITNESS: I would disagree with that
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`statement.
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` Q. (By Mr. Anstaett) All right. Could you look
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`at paragraph 35 of your declaration?
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` A. Yes.
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` Q. And in that paragraph you say, "Because of the
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`difficulty that many patients experience with daily GA
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`injections, a few small studies exploring alternate day
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`injections were described in the literature as of
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`2009," correct?
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` A. Correct.
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` Q. And you would agree with that, right?
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` A. I would agree with that statement.
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` Q. Okay. And you'd also agree with me, would you
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`not, that prior to August of 2009 there were at least a
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`few studies exploring alternate day injections of GA
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`that were described in the literature, correct?
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` A. That is this statement I have here in 35.
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` Q. Okay. All right. And one of the studies --
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`you cite a couple of those studies in your declaration,
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`correct?
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` A. I do.
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` Q. All right. And one of those studies of less
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`frequent than daily dosing of glatiramer acetate as of
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`2009 was conducted by Dr. Omar Khan, correct?
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` A. Correct.
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` Q. All right. Do you know Dr. Khan?
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` A. I do.
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` Q. How do you know him?
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` A. We have been a colleague for many years.
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` Q. Okay. What is Dr. Khan's reputation in the
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`field, in your field?
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` MR. BENNETT: Objection; vague.
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` THE WITNESS: I cannot speak to his
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`overall reputation. His reputation from my standpoint
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`is positive.
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` Q. (By Mr. Anstaett) Okay. He's a reputable
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`scientist in your estimation?
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` A. In my estimation he is.
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` Q. Okay. Now, in paragraph 35 you say that none
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`of those studies with less frequent than daily dosing
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`in the art in 2009 changed the standard of care
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`concerning glatiramer acetate as of 2009, correct?
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` A. Correct.
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` Q. All right. What does it take to change the
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`standard of care for a disease-modifying therapy in
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`multiple sclerosis?
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` A. A number of factors are involved in changing a
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`standard of care, the most principal being that there
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`is solid scientific evidence that a change in solid
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`[sic] of care is in the best clinical interest of the
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`patient.
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` Q. Okay. You said there were a number of
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`factors. Are there others?
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` A. Feasibility of change in care would include
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`access to medication, whether the patient would, in
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`fact, be able to get the product and administer it as
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`being suggested.
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` Q. All right. So to change the standard of care
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`or the -- the different dosing regimen would have to be
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`available to patients. Is that --
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` A. Correct.
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` MR. BENNETT: Objection.
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` Q. (By Mr. Anstaett) Okay. And you said there
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`has to be solid scientific evidence that a change in
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`care is in the best clinical interest of the patient.
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`What would, in your estimation, constitute solid
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`scientific evidence sufficient to change the standard
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`of care for dosing a disease-modifying therapy in
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`multiple sclerosis?
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` A. There would have to be a consensus of the
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`persons of ordinary skill in the art that this was the
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`correct move and that this consensus was made public.
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` Q. Okay. How -- on what -- in your experience,
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`what would be required for there to be consensus on
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`that topic?
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` A. At meetings there would have to be discussions
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`and agreement on the subject, and the critical data
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`would be presented and peer reviewed.
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` Q. Okay. And is this a consensus that must exist
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`amongst all or a substantial portion of skilled
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`artisans?
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` MR. BENNETT: Objection to the form.
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` THE WITNESS: I would agree that a
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`substantial proportion of the involved parties would
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`have to be in agreement.
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` Q. (By Mr. Anstaett) Okay. And you said
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`critical data would have to be presented and peer
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`reviewed. What did you mean by "critical data"?
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` A. Either large, well-controlled clinical trials
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`or a substantial number of independent smaller trials
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`that could be analyzed in a meta-analysis that would
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`give clinically meaningful information.
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` Q. Okay. You say in paragraph 15 to 18 of your
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`declaration that you've been informed about certain
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`legal principles concerning obviousness. Do you see
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`that?
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` A. Yes, I do.
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` Q. All right. According to your understanding,
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`does information in the prior art have to change the
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`standard of care concerning glatiramer acetate in order
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`to be relevant to the issue of obviousness?
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` MR. BENNETT: Objection to the form,
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`calls for a legal conclusion.
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` THE WITNESS: The definition of
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`obviousness includes the scope and content of the prior
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`art. As a medical person, when I think of scope and
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`content, it is what I've been referring to as to the
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`quality of the research, the size of the research, and
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`the importance of the research.
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` Q. (By Mr. Anstaett) Okay. So quality of the
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`research, size of the research, important of the
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`research are three factors; is that correct?
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` A. Among others.
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` Q. Okay. And those are principles I assume
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`you've applied in selecting the references which you
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`rely on in your declaration. Is that fair to say?
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` A. I would not have thought to say it that way.
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` Q. Okay. You make a number of -- you have a
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`number of opinions that you express in your declaration
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`about what a person of ordinary skill in the art would
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`have expected with respect to less frequent dosing of
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`glatiramer acetate in 2009, correct?
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` A. I would not say expected at all. I would say
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`that we had a number of prior arts that were listed as
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`meaningful data points for the support of the
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`statements that I make in m