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` U N I T E D S T A T E S P A T E N T A N D T R A D E M A R K O F F I C E
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` B E F O R E T H E P A T E N T T R I A L A N D A P P E A L B O A R D
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` C A S E I P R 2 0 1 5 - 0 1 2 0 5
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` P a t e n t 6 , 1 1 4 , 3 1 9
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` A K O R N , I N C . )
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` P e t i t i o n e r )
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` v s . )
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` S E N J U P H A R M A C E U T I C A L C O . , L T D )
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` M I T S U B I S H I C H E M I C A L C O R P O R A T I O N )
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` P a t e n t O w n e r )
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` D e p o s i t i o n o f E r n i n g X i a , P h . D .
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` W a s h i n g t o n , D . C .
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` R e p o r t e d b y : B o n n i e L . R u s s o
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`2 2
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`SENJU-MITSUBISHI 2095
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`

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` Deposition of Erning Xia, Ph.D. held at:
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`Page 2
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` Sterne Kessler Goldstein Fox
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` 1100 New York Avenue, N.W.
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` Washington, D.C.
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` Pursuant to Notice, when were present on behalf
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` of the respective parties:
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` APPEARANCES:
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` On behalf of the Petitioner:
`
` STERNE KESSLER GOLDSTEIN FOX
`
` CHANDRIKA VIRA, Esq.
`
` R. WILSON "TREY" POWERS, III, Ph.D., Esq.
`
` 1100 New York Avenue, N.W.
`
` Washington, D.C. 20005
`
` 202-371-2600
`
` cvira@skgf.com
`
` tpowers@skgf.com
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` On behalf of the Patent Owner:
`
` JOHN KAPPOS, Esq.
`
` O'MELVENY & MYERS, LLP
`
` 610 Newport Center Drive, 17th Floor
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` Newport Beach, California 92660
`
` 949-823-6900
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` jkappos@omm.com
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`Page 4
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` C O N T E N T S
` EXAMINATION OF ERNING XIA, Ph.D. PAGE
` BY MR. KAPPOS 7
` 219
` BY MS. VIRA 214
`
` EXHIBITS
` Exhibit 2078 International Application 92
` Number PCT/US98/23818
` Exhibit 2079 International Publication 97
` Number WO 99/24543
` Exhibit 2080 Excerpt of The American 106
` Heritage Dictionary
` Exhibit 2081 Declaration of Diane Pang 126
` Regarding Authentication
` of Omnipred
` Exhibit 2082 Declaration of Diane Pang 131
` Regarding Authentication
` of Durezol Label from 2008
` Exhibit 2083 Declaration of Diane Pang 149
` Regarding Authentication
` of OTC (Nonprescription)
` Drugs Approval
` Exhibit 2084 Declaration of Diane Pang 154
` Regarding Authentication
` of Systane Balance Label
` Exhibit 2085 Declaration of Diane Pang 156
` Regarding Authentication
` of Retaine MGD Label
` Exhibit 2086 Declaration of Diane Pang 158
` Regarding Authentication
` of Refresh Optive Advanced
` Label
` Exhibit 2087 Declaration of Diane Pang 161
` Regarding Authentication
` of Soothe XP Label
`
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` EXHIBITS (CONTINUED:)
` Exhibit 2088 Petitioner's Reply to 188
` Patent Owner's Response
` Exhibit 2089 U.S. Patent Application 188
` Publication
` 2009/0082337 A1
` Exhibit 2090 Article entitled "Dose 190
` uniformity of topical
` corticosteroid preparations:
` Difluprednate ophthalmic
` emulsion 0.05% versus branded
` and generic prednisolone
` acetate ophthalmic
` suspension 1%"
` Exhibit 2091 Declaration of Diane Pang 197
` Regarding Authentication
` of Maxidex 0.1% Label
` Exhibit 2092 Declaration of Diane Pang 199
` Regarding Authentication
` of FML Forte 0.25% Label
` Exhibit 2093 Declaration of Diane Pang 199
` Regarding Authentication
` of Vexol 1% Label
` Exhibit 2094 British Pharmacopoeia 1998 204
` Volume II
`
` PREVIOUSLY MARKED EXHIBITS:
` Exhibit 1010 U.S. Patent 5,496,811
` Exhibit 1011 Excerpt of Remington's
` 18th Edition
` Exhibit 1012 International Publication
` Number WO 95/31211
` Exhibit 1018 Declaration of
` Erning Xia, Ph.D.
` Exhibit 1026 Declaration of
` Erning Xia, Ph.D.
` In Support of Petitioner's
` Reply
` Exhibit 1033 Systane Products Information
` Exhibit 1034 OCuSOFT Information
` Exhibit 1035 Refresh Optive Advanced
` Information
`
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` EXHIBITS (CONTINUED):
` Exhibit 2007 Excerpt of Textbook of
` Ocular Pharmacology
` Exhibit 2010 Abstract entitled "Comparative
` Intraocular Levels of
` Pilocarpine Achieved with
` Drops and Repository
` Preparations"
` Exhibit 2017 Excerpt of NDA 22-212/S-003
` Exhibit 2040 Drugs@FDA Information
` Exhibit 2043 US Patent Application
` Publication 2007/0110812 A1
` Exhibit 2044 US Patent Application
` Publication 2010/0234336 A1
` Exhibit 2045 Article entitled "Intraocular
` pressure elevation from
` topical difluprednate use"
`
` (Exhibits included with transcript.)
`
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`Page 7
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` P R O C E E D I N G S
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` ERNING XIA, Ph.D.,
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` was called for examination by counsel and,
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` after having been duly sworn by the Notary, was
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` examined and testified as follows:
`
` EXAMINATION BY COUNSEL FOR PATENT OWNER
`
` BY MR. KAPPOS:
`
` Q. Good morning, Dr. Xia.
`
` Can you tell us your full name,
`
` please.
`
` A. My full name is Erning Xia. Spelled
`
` E-R-N-I-N-G, X-I-A.
`
` Q. And is there any reason that you
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` can't give truthful testimony today, anything
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` like you're ill or medication or anything like
`
` that?
`
` A. I don't think so.
`
` Q. Okay. I'm handing you Exhibit 1026
`
` in this matter.
`
` Can you identify this as the -- your
`
` second declaration that you filed in this
`
` matter?
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` A. Yes, this is my second declaration.
`
` Q. And is that your signature on Page
`
`Page 8
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` 64?
`
` A. Yes.
`
` So, John, sorry. Before you move
`
` forward, I have a little typo here in my second
`
` declaration.
`
` Q. What paragraph are you looking at?
`
` A. It's Page 52. And speaking 1033 --
`
` Q. I'm sorry. So 52 --
`
` A. Page 52.
`
` Q. Yes.
`
` A. And again, 1033, the date I put down
`
` here should be May 20. So that's a little typo
`
` here. Here it's 26. It should be 20, May 20.
`
` Q. Okay. What line are you on? Are
`
` you in the footnote, or are you in the body of
`
` the text?
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` A. Footnote, Line 5.
`
` Q. Footnote 4? I see. Okay.
`
` A. Yeah.
`
` Q. So that should be --
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` A . M a y 2 0 .
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` Q . T h a t ' s w h a t i t s a y s . M a y 2 0 .
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` A . I t s a y s M a y 2 6 h e r e .
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` Q . Y o u ' r e o n P a g e 5 2 ?
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` A . 5 2 , y e a h .
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` Q . A m I l o o k i n g a t t h e w r o n g o n e h e r e ?
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` M i n e s a y s M a y 2 0 .
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` A . N o , h e r e . L i n e 5 s h o u l d b e M a y 2 0
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` h e r e .
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` Q . A h , g o t i t . O k a y .
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` A . M y b a d .
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` Q . O k a y . A n y t h i n g e l s e t h a t y o u ' r e
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` a w a r e o f t h a t ' s - -
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` A . T h a t ' s i t , y e a h . T h a n k y o u .
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` Q . A b o u t h o w m a n y h o u r s d i d y o u s p e n d
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` p r e p a r i n g y o u r s e c o n d d e c l a r a t i o n ?
`
` A . F o r t h i s d e p o s i t i o n , y o u m e a n ?
`
` Q . T h e d e c l a r a t i o n .
`
` A . A h , t h e d e c l a r a t i o n . H o w m a n y
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` h o u r s ?
`
` Q . Y e a h .
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` A . I d o n ' t r e m e m b e r h o w m a n y h o u r s .
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` Q. Do you remember how many hours you
`
` billed for on the matter for the declaration?
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` MS. VIRA: Objection. Relevance.
`
` THE WITNESS: I don't remember.
`
` BY MR. KAPPOS:
`
` Q. Who wrote your second declaration?
`
` A. I wrote my second declaration in
`
` conjunction with my counsel.
`
` Q. So in Paragraph 41 of your second
`
` declaration -- do you have Paragraph 41?
`
` So you cite to the '319 patent.
`
` A. Yes.
`
` Q. The portion of the patent that
`
` refers to allergic conjunctivitis, vernal
`
` conjunctivitis, blepharitis, marginalis,
`
` catarrhal conjunctivitis, uveitis and the like.
`
` Do you see that?
`
` A. Yes.
`
` Q. What part of the eye does allergic
`
` conjunctivitis affect?
`
` A. Can you repeat your question one
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` more time.
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` Q. Yeah. My question was what part of
`
` the eye does allergic conjunctivitis affect?
`
` Is it the anterior or the posterior segment?
`
` MS. VIRA: Objection. Form.
`
` Foundation.
`
` MR. KAPPOS: And I'll note that
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` speaking objections are improper in the
`
` proceeding, Counsel. So please limit your
`
` objection to object to form only and not
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` speaking objections unless there is a privilege
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` issue.
`
` BY MR. KAPPOS:
`
` Q. With that, can you please answer the
`
` question?
`
` MS. VIRA: Counsel, I'll note that
`
` object to foundation is allowed under the PTAB
`
` rules. There's nothing that says you're
`
` limited to just form objections.
`
` BY MR. KAPPOS:
`
` Q. So can you answer the question?
`
` A. Yes. It is within anterior segment
`
` of the eye.
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` Q. And what about vernal
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` conjunctivitis; does that affect the anterior
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` segment of the eye also?
`
` A. I am not sure hundred percent
`
` because I am not eye doctor for treating that
`
` kind of disease.
`
` Q. Do you have any understanding as to
`
` whether, for vernal conjunctivitis, it affects
`
` the posterior or anterior segment of the eye?
`
` A. I'm not sure.
`
` Q. What about catarrhal conjunctivitis;
`
` do you have an understanding as to whether, for
`
` that condition, it affects the anterior or
`
` posterior segment of the eye?
`
` A. I'm not sure.
`
` Q. And what about for uveitis; do you
`
` have an understanding as to whether uveitis
`
` affects the anterior or posterior segment of
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` the eye?
`
` A. The posterior.
`
` Q. I'm sorry. So for uveitis you
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` believe it affects the posterior?
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` A. Yes.
`
` Q. It does not affect the anterior?
`
` MS. VIRA: Objection. Form.
`
` THE WITNESS: I'm not sure if it
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` affects both posterior and anterior because I'm
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` not eye care practitioner.
`
` BY MR. KAPPOS:
`
` Q. So you said you're not sure if it
`
` affects both the posterior and the anterior; is
`
` that correct?
`
` A. Yes.
`
` Q. I am handing you AKN 1012, which is
`
` the Ding PCT publication.
`
` Do you recognize this as a reference
`
` that you've analyzed for this case?
`
` A. Yes.
`
` Q. I would like you to turn to the
`
` table, Table A, which lists a number of
`
` formulations that were tested, correct?
`
` A. Yes.
`
` Q. The formulation in the -- well, the
`
` first column lists ingredients.
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` And then the next column that says
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` "Castor Oil," the formulation that is described
`
` in that castor oil column, that's a solution,
`
` correct?
`
` MS. VIRA: Objection. Form.
`
` THE WITNESS: Column 2?
`
` BY MR. KAPPOS:
`
` Q. Yeah, the one that says "castor
`
` oil."
`
` A. Yeah.
`
` Q. Is that a solution in Ding? Is that
`
` describing a solution?
`
` A. What do you mean by "solution,"
`
` definition of a solution?
`
` Q. Well, what is your definition of a
`
` solution?
`
` A. Most of time my definition of
`
` solution is water-based solution, liquid form.
`
` Q. Can you have a solution in an
`
` organic solvent?
`
` MS. VIRA: Objection. Form. Scope.
`
` THE WITNESS: Repeat it again,
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` please.
`
` BY MR. KAPPOS:
`
` Q. Is it possible to have a solution
`
` that is in an organic solvent?
`
` MS. VIRA: Same objections.
`
` THE WITNESS: I was try to think
`
` what the name for oil-based solutions. I want
`
` to give you better definition here.
`
` BY MR. KAPPOS:
`
` Q. Well, maybe I can rephrase the
`
` question.
`
` Is the formulation in Table A of
`
` Ding Exhibit AKN 1012, is that formulation
`
` that's labeled castor oil and oil-based
`
` solution?
`
` A. I can say that it's oil-based
`
` solutions.
`
` Q. So it is a type of solution,
`
` correct?
`
` A. It is.
`
` Q. Okay. What about the -- in the
`
` second column, do you see it says "castor oil
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` and water emulsion"?
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` That's an emulsion, correct?
`
` A. Yes.
`
` Q. And then in the next column, the one
`
` that is labeled "Aqueous Alpha-Cyclodextrin,"
`
` that formulation would be considered a
`
` solution, correct?
`
` A. Because I don't have the solution in
`
` front of me, I'm not sure I can say hundred
`
` percent it's a solution.
`
` Q. Well, you've got the patent though.
`
` Can you look at the patent and tell
`
` me whether it's a solution?
`
` MS. VIRA: Objection. Form.
`
` THE WITNESS: You want me to look at
`
` this patent?
`
` BY MR. KAPPOS:
`
` Q. I want you to tell me if you can
`
` tell from the Ding reference what is the
`
` formulation that's in the -- that's labeled
`
` "Aqueous Alpha-Cyclodextrin."
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` A. Can you point out the certain pages
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` for me says it is solution?
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` Q. Well, if you look at Table A, right,
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` it's telling you what the components are in
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` that formulation, right? It says cyclosporin
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` A; it says cyclodextrin; and it says water.
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` So my question to you is, just
`
` looking at the formulation, can you tell me
`
` whether that is a solution or some other
`
` formulation?
`
` A. Because I do not recall the
`
` solubility limits for cyclodextrin.
`
` Cyclodextrin also have solubility problems.
`
` But I do not remember -- recall at this moment
`
` what solubility limits are of cyclodextrin.
`
` Q. So you have no understanding whether
`
` the aqueous alpha-cyclodextrin is a -- what
`
` formulation that is; is that correct?
`
` MS. VIRA: Objection. Form.
`
` THE WITNESS: No. I have ideas why
`
` they prepare the aqueous formulations using
`
` cyclodextrin. I understand.
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` Q. And why did they do that?
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` A. Because cyclosporin-A is water
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` insoluble drug. In order to enhance the
`
` solubility of drug, cyclodextrin --
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` alpha-cyclodextrin is a good compound to use to
`
` increase the solubility of cyclosporin-A. This
`
` is why they use the cyclodextrin.
`
` Q. And so cyclodextrin would have been
`
` used in Ding in order to make a solution of
`
` cyclosporin, correct?
`
` MS. VIRA: Objection. Form.
`
` THE WITNESS: In order to enhance
`
` cyclosporin-A's .1 percent to dissolve in the
`
` aqueous solutions -- aqueous-based solution.
`
` BY MR. KAPPOS:
`
` Q. Well, the aqueous cyclodextrin that
`
` is shown in Table A, that is not an emulsion,
`
` is it?
`
` A. It is not emulsion.
`
` Q. And it is not a suspension, is it?
`
` A. If both ingredients are hundred
`
` percent dissolved, it is not a suspension.
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` Q. The next column over that says
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` "Miglyol Oil and Water Emulsion," that is a --
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` formulation would be considered an emulsion,
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`Page 19
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` correct?
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` A. Yes.
`
` Q. And the next one over, the "Polyoxyl
`
` 40," that column is describing a solution,
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` correct?
`
` A. I'm not sure this is solution.
`
` Q. Why not?
`
` MS. VIRA: Objection. Form.
`
` THE WITNESS: Because I did not have
`
` the solution in front of me, I cannot say it's
`
` a clear solution or not clear.
`
` BY MR. KAPPOS:
`
` Q. Well, but you've got the ingredients
`
` that are shown in Table A.
`
` So can you tell from the ingredients
`
` that are listed in the table whether polyoxyl
`
` 40 is a emulsion, suspension or solution?
`
` A. I don't know. I cannot define for
`
` Ding. Ding is the author of this. He did not
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` define is this solution or suspension.
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` Q. Do you have any understanding as to
`
` whether the polyoxyl 40, as formulated, would
`
` be a solution or something else?
`
` MS. VIRA: Objection. Form.
`
` THE WITNESS: Because I'm not sure
`
` the polyoxyl 40 stearate is 20 percent, it's
`
` going to be enough to dissolve .05 percent of
`
` cyclosporin-A.
`
` BY MR. KAPPOS:
`
` Q. What about the polyoxyl 40 with
`
` edetate; do you have any understanding of what
`
` that formulation is?
`
` A. I would think it would be very
`
` similar formulation to the formulation we just
`
` discussed, polyoxyl 40. The only difference is
`
` adding acenol and EDTA in this formulation.
`
` Q. Okay. Well, let me ask this way:
`
` The polyoxyl 40 with edetate, that's not a
`
` suspension, correct?
`
` A. I'm not a hundred percent sure
`
` because I do not see in front of me. I don't
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` know is going to be clear solution or is going
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` to be hazy solution because cyclodextrin --
`
` cyclosporin-A is very difficult compound to
`
` dissolve.
`
` Q. Based on the Ding reference that you
`
` have reviewed, the polyoxyl 40 with edetate is
`
` not described as a suspension, correct?
`
` A. Can you repeated your question?
`
` Q. Yes.
`
` Based on the Ding reference that you
`
` reviewed, the polyoxyl 40 with edetate
`
` formulation is not described as a suspension,
`
` correct?
`
` A. It is not described as suspension.
`
` Also it is not described at all.
`
` Q. Okay. And the same is true for the
`
` polyoxyl 40 formulation, correct?
`
` MS. VIRA: Objection. Form.
`
` BY MR. KAPPOS:
`
` Q. It's not described as a suspension,
`
` correct?
`
` A. Most the formulation in this table
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` is not described clearly to me.
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` Q. Okay. And so none of the
`
` formulations in Table A of Ding are described
`
` as a suspension, correct?
`
` MS. VIRA: Objection. Form.
`
` THE WITNESS: So only two
`
` formulation are described here. Those are
`
` emulsions. Other four formulation he did not
`
` describe them as solution, suspension.
`
` BY MR. KAPPOS:
`
` Q. And so none of the formulations in
`
` Table A are described in Ding as being a
`
` suspension, correct?
`
` MS. VIRA: Objection. Form.
`
` THE WITNESS: It is not described as
`
` suspension. Also it is not described as a
`
` clear solution.
`
` BY MR. KAPPOS:
`
` Q. And there is no evidence that you
`
` are aware of that any of the formulations in
`
` Table A are, in fact, suspensions, correct?
`
` MS. VIRA: Objection. Form.
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` THE WITNESS: John, if I read the
`
` Table A as it is, my concern is -- I can even
`
` pick any example, any column, and say polyoxyl
`
` 40, 20, what is units of 20?
`
` BY MR. KAPPOS:
`
` Q. Well, doesn't it say milligram?
`
` MS. VIRA: Objection. Form.
`
` THE WITNESS: So based on this
`
` table, he prepared a solution one gram of
`
` solutions of suspensions. I suppose I never
`
` see people prepare a one gram of solution for
`
` testing. This is what it says. Suspension
`
` size is one gram.
`
` BY MR. KAPPOS:
`
` Q. Okay. But you just said a moment
`
` ago, I believe, that you can't tell whether
`
` these are a solution or a suspension.
`
` Is that correct, that you cannot
`
` tell whether any of the formulations in Table A
`
` are a suspension, correct?
`
` A. Yes. Because if I can get other
`
` units straightened out, I have to make sure
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` that all the units put together is not more
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` than one gram. If it is too high, it may not
`
` have clear solution.
`
` Q. And so would you agree with me, Dr.
`
` Xia, that there is no results that are reported
`
` in Ding that compare an emulsion to a
`
` suspension based on the results that are
`
` reported, correct?
`
` MS. VIRA: Objection. Form.
`
` THE WITNESS: When you say -- John,
`
` when you said "results," what do you refer to?
`
` BY MR. KAPPOS:
`
` Q. The results that are report -- well,
`
` let's turn and look at Figures 1 to 4.
`
` Figures 1 to 4 report the results of
`
` comparing the different formulations that are
`
` reported in Ding, correct?
`
` A. Yes and no.
`
` Q. I'm sorry. You said, "Yes and no"?
`
` A. Yeah.
`
` Q. What do you mean by that?
`
` A. For example, Table A has six
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` formulations. Figure A only have five
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` formulations.
`
` Q. Okay. And then Figure 2 has six
`
` formulations?
`
` MS. VIRA: Objection. Form.
`
` THE WITNESS: But Figure 2 also had
`
` ointment there. So can you point out ointment
`
` formulation in Table A for me?
`
` BY MR. KAPPOS:
`
` Q. I was going to ask you that
`
` question.
`
` Do you know which of the
`
` formulations in Table A is an ointment?
`
` A. I don't know. That's what -- why I
`
` was review this, and I cannot really match the
`
` formulation from the Table A to the figures.
`
` Q. So Ding is unclear; is that correct?
`
` MS. VIRA: Objection. Form.
`
` THE WITNESS: My answer was yes and
`
` no. Yes, he was correct for four solutions. I
`
` believe that is -- I can match those. But last
`
` two formulations was not described clear to me.
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` BY MR. KAPPOS:
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` Q. Okay. And back to my question,
`
` which was the results that are reported in
`
` Ding, they don't allow you to compare the
`
` emulsion to a suspension based on these
`
` results, correct?
`
` MS. VIRA: Objection. Form.
`
` THE WITNESS: Repeat your question,
`
` please, one more time. Thank you.
`
` BY MR. KAPPOS:
`
` Q. And my question was, the results
`
` that are reported in Ding, they do not allow
`
` you to compare the emulsion to a suspension
`
` based on these results, correct?
`
` MS. VIRA: Objection. Form.
`
` THE WITNESS: So assumption is that,
`
` if last two formulation is not clear solution,
`
` could it be considered a suspension. That's
`
` what it is difficult to identify.
`
` BY MR. KAPPOS:
`
` Q. But you said the last two
`
` formulations are not even shown in the --
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` perhaps I misunderstood.
`
` Are the last two formulations even
`
` shown in the comparative results?
`
` MS. VIRA: Objection. Form.
`
` THE WITNESS: It is not clear to me.
`
` BY MR. KAPPOS:
`
` Q. Well, I thought you testified a
`
` moment ago -- maybe -- perhaps I was unclear.
`
` In Table A do you see results that
`
` are reported for polyoxyl 40 or polyoxyl 40
`
` with edetate -- do you see those results in the
`
` charts that are in Figures 1 through 4 of Ding?
`
` A. You refers last two formulations,
`
` last columns, right?
`
` Q. Yeah. That's what I said. In Table
`
` A.
`
` MS. VIRA: Objection. Form.
`
` THE WITNESS: It's not named
`
` properly. The list is not named properly. If
`
` you look at the concentration set .05. But
`
` they do put the Santen formulation. I --
`
` that's where confusion is coming.
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` B Y M R . K A P P O S :
`
` Q . W e l l , o k a y . A n d s o b a c k t o m y
`
` q u e s t i o n , w h i c h i s t h e r e s u l t s t h a t a r e
`
` r e p o r t e d i n D i n g , t h e y d o n o t a l l o w y o u t o
`
` c o m p a r e t h e e m u l s i o n t o a s u s p e n s i o n b a s e d o n
`
` t h e s e r e s u l t s , c o r r e c t ?
`
` M S . V I R A : O b j e c t i o n . F o r m .
`
` T H E W I T N E S S : Y e s . I t ' s n o t c l e a r
`
` t o m e . S o I c a n c o m p a r e t h e m , b u t I w i l l n o t
`
` d r a w c o n c l u s i o n s h u n d r e d p e r c e n t .
`
` B Y M R . K A P P O S :
`
` Q . Y o u w o u l d n ' t b e a b l e t o d r a w a n y
`
` c o n c l u s i o n a s t o h o w t h e e m u l s i o n - -
`
` A . W i t h a h u n d r e d p e r c e n t c o n f i d e n c e .
`
` Q . O k a y . L e t m e a s k t h e q u e s t i o n .
`
` Y o u w o u l d n ' t b e - -
`
` M S . V I R A : L e t h i m a s k t h e q u e s t i o n
`
` s o i t w i l l b e c l e a r f o r t h e r e c o r d .
`
` T H E W I T N E S S : T h a n k y o u .
`
` B Y M R . K A P P O S :
`
` Q . S o y o u ' r e s a y i n g y o u w o u l d n ' t b e
`
` a b l e t o d r a w a n y c o n c l u s i o n a s t o h o w t o
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`1
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`9
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`1 0
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`1 1
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`1 2
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`1 3
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`1 4
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`1 5
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`1 6
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`1 7
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`1 8
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`1 9
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`2 0
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`2 1
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`2 2
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` c o m p a r e t h e e m u l s i o n o f D i n g t o a s u s p e n s i o n ,
`
` c o r r e c t ?
`
` M S . V I R A : O b j e c t i o n . F o r m .
`
` T H E W I T N E S S : T h a t w a s y o u r
`
` q u e s t i o n ? I - - s o - - n o . I m e a n i f I h a v e
`
` c l e a r u n d e r s t a n d i n g t h e l a s t f o r m u l a t i o n i s
`
` s o l u t i o n , a l l s u s p e n s i o n s . S o I c a n g u e s s
`
` m a y b e i t ' s s o l u t i o n ; i t ' s m a y b e s u s p e n s i o n s .
`
` B u t I c a n n o t j u s t s a y i t i s n o t a s o l u t i o n .
`
` B Y M R . K A P P O S :
`
` Q . S o c y c l o s p o r i n i s t h e a c t i v e
`
` i n g r e d i e n t i n t h e D i n g p u b l i c a t i o n , c o r r e c t ?
`
` A . I n T a b l e 1 .
`
` Q . A n d c y c l o s p o r i n i s t h e a c t i v e
`
` i n g r e d i e n t o r a c t i v e m o l e c u l e i n t h e R e s t a s i s
`
` p r o d u c t , c o r r e c t ?
`
` M R . K A P P O S : O b j e c t i o n . F o r m .
`
` S c o p e . R e l e v a n c e .
`
` T H E W I T N E S S : C a n y o u r e p e a t y o u r
`
` q u e s t i o n .
`
` B Y M R . K A P P O S :
`
` Q . I ' m s i m p l y a s k i n g w h e t h e r y o u h a v e
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`1
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`2
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`8
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`9
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`1 0
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`1 1
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`1 2
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`1 3
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`1 4
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`1 5
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`1 6
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`1 7
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`1 8
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`1 9
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`2 0
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`2 1
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`2 2
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` an understanding that cyclosporin is the active
`
` ingredient in the product Restasis.
`
` MS. VIRA: Same objections as above.
`
` THE WITNESS: Sorry. I'm not
`
` prepared to offer that opinions here,
`
` cyclosporin is only active in the Restasis
`
` products.
`
` BY MR. KAPPOS:
`
` Q. Is it one of the actives in
`
` Restasis?
`
` MS. VIRA: Objection. Form.
`
` Foundation. Scope. Relevance.
`
` THE WITNESS: This is not covered in
`
` my declarations. I don't have benefit to study
`
` the whole formulations. And my preliminary
`
` understanding cyclosporin-A is involved
`
` actives.
`
` BY MR. KAPPOS:
`
` Q. It is one of the activities, is your
`
` understanding, correct?
`
` A. Yes.
`
` Q. And cyclosporin has a different
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`Veritext Legal Solutions
`215-241-1000 ~ 610-434-8588 ~ 302-571-0510 ~ 202-803-8830
`
`

`
`Page 31
`
` molecular weight than difluprednate, correct?
`
` MS. VIRA: Objection. Form.

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