Confidential - Subject to The Protective Order
`Robert O. Williams, III, Ph.D. - March 9, 2016
`
` 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
`
` 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
`
`Page 1
`
`_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _
`
`I N N O P H A R M A L I C E N S I N G , I N C . , )
`
`I N N O P H A R M A L I C E N S I N G L L C , )
`
`I N N O P H A R M A I N C . , I N N O P H A R M A L L C )
`
`M Y L A N P H A R M A C E U T I C A L S I N C . a n d )
`
`M Y L A N I N C . , )
`
` P e t i t i o n e r s , ) C a s e N o s .
`
` v s . ) I P R 2 0 1 5 - 0 0 9 0 2
`
`S E N J U P H A R M A C E U T I C A L C O . , L T D . , ) I P R 2 0 1 5 - 0 0 9 0 3
`
`B A U S C H & L O M B , I N C . , a n d B A U S C H )
`
`& L O M B P H A R M A H O L D I N G S C O R P . , )
`
` P a t e n t O w n e r . )
`
`_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ )
`
` C O N F I D E N T I A L S U B J E C T T O T H E P R O T E C T I V E O R D E R
`
` V I D E O T A P E D D E P O S I T I O N O F
`
` R O B E R T O . W I L L I A M S , I I I , P h . D .
`
` A u s t i n , T e x a s
`
` W e d n e s d a y , M a r c h 9 , 2 0 1 6
`
`GregoryEdwards, LLC | Worldwide Court Reporting
`GregoryEdwards.com | 866-4Team GE
`
`IPR2015-01099
`IPR2015-01097
`IPR2015-01100
`IPR2015-01105
`
`Lupin EX1099
`Page 1
`
`

`
`Confidential - Subject to The Protective Order
`Robert O. Williams, III, Ph.D. - March 9, 2016
`
`Page 2
`
`2 (Pages 2 to 5)
`
`Page 4
`
`1 A P P E A R A N C E S (continued)
`
`2 3
`
`FOR PATENT OWNER:
`4 Finnegan, Henderson, Farabow,
`5 Garrett & Dunner, LLP
`6 901 New York Avenue, NW
`7 Washington, D.C. 20001
`8 (202) 408-4000
`9 By: Justin J. Hasford
`10 justin.hasford@finnegan.com
`11 - and -
`12 Finnegan, Henderson, Farabow
`13 Garrett & Dunner, LLP
`14 303 Peachtree Street, NE
`15 3800 Suntrust Plaza
`16 Atlanta, Georgia 30308
`17 (404) 653-6400
`18 By: Jessica M. Lebeis
`19 jessica.lebeis@finnegan.com
`20
`21
`22
`
`1 2 3 4 5
`
` ORAL VIDEOTAPED DEPOSITION OF ROBERT O.
`6 WILLIAMS, III, Ph.D., produced as a witness at the
`7 instance of the Petitioner and duly sworn, was
`8 taken in the above-styled and numbered cause on
`9 the 9th day of March 2016, from 8:09 a.m. to
`10 12:32 p.m., before Rebecca J. Callow, Registered
`11 Merit Reporter, Certified Realtime Reporter,
`12 Registered Professional Reporter and Notary Public
`13 for the State of Texas, reported by computerized
`14 stenotype machine at the offices of Hilton Austin
`15 Airport, 9515 Hotel Drive, Austin, Texas.
`16
`17
`18
`19
`20
`21
`22
`
`Page 3
`
`Page 5
`
` A P P E A R A N C E S (continued)
`
`FOR LUPIN:
` Crowell Moring
` 1001 Pennsylvania Avenue, NW
` Washington, D.C. 20004
` (212) 624-3947
` By: Deborah H. Yellin
` dyellin@crowell.com
`
`ALSO PRESENT:
` Jason Lemley, Videographer
`
`1
`
`2 3
`
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`
`1 A P P E A R A N C E S
`
`2 3
`
`FOR PETITIONER:
`4 Alston & Bird, LLP
`5 4721 Emperor Boulevard
`6 Suite 400
`7 Durham, North Carolina 27703
`8 (919) 862-2200
`9 By: Jitendra “Jitty” Malik, Ph.D.
`10 jitty.malik@alston.com
`11 - and -
`12 Alston & Bird, LLP
`13 333 South Hope Street
`14 16th Floor
`15 Los Angeles, California 90071
`16 (213) 576-1000
`17 By: Evan T. Woolley
`18 evan.woolley@alston.com
`19
`20
`21
`22
`
`GregoryEdwards, LLC | Worldwide Court Reporting
`GregoryEdwards.com | 866-4Team GE
`
`Page 2
`
`

`
`Confidential - Subject to The Protective Order
`Robert O. Williams, III, Ph.D. - March 9, 2016
`
`3 (Pages 6 to 9)
`
`Page 8
`
` E X H I B I T S (continued)
`
` PREVIOUSLY MARKED EXHIBITS
`EXHIBIT DESCRIPTION PAGE
`Exhibit 1059 Excerpt" "Remington: The 80
` Science and Practice of
` Pharmacy" 20th Edition pp 830
` through 832
`
`Exhibit 1067 Deposition Transcript: 17
` Videotaped Deposition of Robert
` O. Williams, III, Ph.D. taken
` February 25, 2016
`
`Exhibit 1069 United States Patent 71
` Application No. 2008/0274194
`
`Exhibit 1070 U.S. Patent No. 6,495,120 61
`
`Exhibit 1072 United States Patent No. 65
` 6,509,028
`///
`
` E X H I B I T S (continued)
`
`Page 9
`
` PREVIOUSLY MARKED EXHIBITS
`EXHIBIT DESCRIPTION PAGE
`Exhibit 2013 Prescribing information for 111
` Prolensa
`
`Exhibit 2014 United States Patent No. 32
` 5,630,793
`
`Exhibit 2026 Prescribing information for 106
` Xibrom
`
`Exhibit 2027 Prescribing Information for 110
` Bromday
`
`Exhibit 2029 New York Times article: "New 74
` Painkiller Is Withdrawn After 4
` Death"
`
`///
`
`1
`
`2 3
`
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`
`1
`
`2 3
`
`4
`5
`6
`
`7 8
`
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`
` I N D E X
`
`WITNESS: ROBERT O. WILLIAMS, III, PH.D.
`
`Page 6
`
` PAGE
`Examination by Mr. Malik .........................15
`Examination by Mr. Hasford ......................141
`Further Examination by Mr. Malik ................146
` -o0o-
`
` E X H I B I T S
`
`Page 7
`
` PREVIOUSLY MARKED EXHIBITS
`EXHIBIT DESCRIPTION PAGE
`Exhibit 1001 United States No. 8,669,290 15
`
`Exhibit 1019 Journal Article: "Comparing the 93
` Surface Chemical Properties and
` the Effect of Salts on the
` Cloud Point of a Conventional
` Nonionic Surfactant, Octoxynol
` 9 (Triton X-100), and of Its
` Oligomer, Tyloxapol (Triton
` WR-1339) Author: Hans Schott
`
`Exhibit 1028 United States Patent No. 77
` 5,475,034
`
`Exhibit 1057 FDA Inactive Ingredient Guide - 43
` 1997
`
`///
`
`1
`
`2 3
`
`4 5
`
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`
`1
`
`2 3
`
`4
`5
`
`6 7
`
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`
`GregoryEdwards, LLC | Worldwide Court Reporting
`GregoryEdwards.com | 866-4Team GE
`
`Page 3
`
`

`
`Confidential - Subject to The Protective Order
`Robert O. Williams, III, Ph.D. - March 9, 2016
`
`4 (Pages 10 to 13)
`
`Page 12
`
` E X H I B I T S (continued)
`
` PREVIOUSLY MARKED EXHIBITS
`EXHIBIT DESCRIPTION PAGE
`Exhibit 2115 Curriculum Vitae of Robert O. 18
` Williams, III, Ph.D.
`
`Exhibit 2118 Ophthalmology article: 134
` "Bromfenac Ophthalmic Solution
` 0.07% Dosed Once Daily for
` Cataract Surgery Results of 2
` Randomized Controlled Trials"
`
`Exhibit 2119 Patient Preference and 136
` Adherence article: "Bromfenac
` ophthalmic solution for the
` treatment of postoperative
` ocular pain and inflammation:
` safety, efficacy, and patient
` adherence"
`
`///
`
` E X H I B I T S (continued)
`
`Page 13
`
` PREVIOUSLY MARKED EXHIBITS
`EXHIBIT DESCRIPTION PAGE
`Exhibit 2255 Supplemental Opening Expert 138
` Report of Robert O. Williams,
` III, Ph.D., Ph.D. on
` Innopharma's Infringement and
` Objective Indicia of
` Nonobviousness"
` -o0o-
`
`1
`
`2 3
`
`4
`5
`6
`
`7 8
`
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`
`1
`
`2 3
`
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`
` E X H I B I T S (continued)
`
`Page 10
`
` PREVIOUSLY MARKED EXHIBITS
`EXHIBIT DESCRIPTION PAGE
`Exhibit 2030 Clinical Ophthalmology article 128
` "The ocular distribution of
` C-labeled bromfenac ophthalmic
` solution 0.07% in a rabbit
` model"
`
`Exhibit 2082 Declaration of Robert O. 15
` Williams, III, Ph.D (IPR 902)
`
`Exhibit 2082 Declaration of Robert O. 15
` Williams, III, Ph.D (IPR 903)
`
`Exhibit 2103 Bromfenac Ophthalmic Solution 121
` 0.07% 3.2.P.8.1 Stability
` Summary and Conclusions ISTA
` Pharmaceuticals, Inc. NDA
` 203168
`///
`
` E X H I B I T S (continued)
`
`Page 11
`
` PREVIOUSLY MARKED EXHIBITS
`EXHIBIT DESCRIPTION PAGE
`Exhibit 2110 Bromfenac Ophthalmic Solution 125
` 0.07% 3.2.P.5.6 Justification
` of Specifications Bausch +
` Lomb NBA 203168
`
`Exhibit 2112 Affidavit of Translation of 56
` 2002.6 - 2nd Edition [Bronuck
` Package Insert
`
`Exhibit 2113 Clinical Ophthalmology article: 132
` "The efficacy of bromfenac
` ophthalmic solution 0.07% dosed
` once daily in achieving
` zero-to-trace anterior chamber
` cell severity following
` cataract surgery"
`
`///
`
`1
`
`2 3
`
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`
`1
`
`2 3
`
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`
`GregoryEdwards, LLC | Worldwide Court Reporting
`GregoryEdwards.com | 866-4Team GE
`
`Page 4
`
`

`
`Confidential - Subject to The Protective Order
`Robert O. Williams, III, Ph.D. - March 9, 2016
`
`Page 14
`
` THE VIDEOGRAPHER: Here begins media
`number 1 in the deposition of Robert Williams
`concerning InnoPharma Licensing, Inc., et al. versus
`Senju Pharmaceutical Co., Ltd., et al. Today's date
`is March 9th, 2016. The time is 8:09.
` This deposition is being taken at
`Hilton Austin Airport, 9515 Hotel Drive, Austin,
`Texas 78719.
` I'm Jason Lemley, the videographer,
`and the court reporter is Rebecca Callow from
`Gregory Edwards, LLC.
` Counsel, please identify yourselves
`and state whom you represent.
` MR. MALIK: Jitendra Malik from the
`law firm of Alston & Bird. With me is Evan Woolley,
`and we represent InnoPharma.
` MS. YELLIN: Deborah Yellin of Crowell
`Moring. I represent the Petitioner Lupin.
` MR. HASFORD: Justin Hasford of
`Finnegan on behalf of the patent owner.
` MS. LEIBIS: Jessica Leibis of
`Finnegan, on behalf of the patent owner.
`
`Page 15
`
` THE VIDEOGRAPHER: Thank you. Would
`the court reporter please swear in the witness.
` ROBERT O. WILLIAMS, III, Ph.D.,
`called as a witness, having been duly sworn
`by a Notary Public, was examined and
`testified as follows:
` EXAMINATION
` BY MR. MALIK:
`
` Q. Q. Good morning, Dr. Williams.
`
` Q. Q.
`
` A. A. Good morning.
`
` A. A.
`
` Q. Q. Let me hand you what has been marked as
`
` Q. Q.
`Senju Exhibit 2082, which is your declaration in
`IPR 903 and the '431 patent.
` Let me also hand you what has been
`marked as Senju Exhibit 2082, which is the -- your
`declaration in the 902 case pertaining to the '290
`patent.
` Finally, let me also hand you the '290
`patent which is marked InnoPharma Exhibit 1001.
` Dr. Williams, I'm going to ask you a
`series of questions in connection with the two
`declarations I've handed you.
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`
`5 (Pages 14 to 17)
`
`Page 16
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`
` Can you confirm the two declarations
`
`that I've handed you are indeed your declarations?
`
`
` A. A. They both are. Yes.
`
` A. A.
`
` Q. Q. And is that your signature at the end of
`
` Q. Q.
`the declarations?
`
`
` A. A. Yes, it is.
`
` A. A.
`
` Q. Q. Okay. A couple of ground rules. I'm going
`
` Q. Q.
`to ask that any question that I pose that you answer
`
`from the perspective of a person of ordinary skill
`
`in the art.
`
` Unless you tell me otherwise, I'm going
`
`to assume that it's from the skilled artisan.
`
` Fair enough?
`
`
` A. A. Yes.
`
` A. A.
`
` Q. Q. Okay. I'm also going to focus most of my
`
` Q. Q.
`deposition on the declaration for the 902 case which
`
`pertains to the '290 case.
`
` But unless you tell me otherwise, I'll
`
`assume that the answer also applies to the '431
`
`patent.
`
` Fair enough?
`
`
` A. A. Yes.
`
` A. A.
`
`Page 17
`
`
` Q. Q. Okay.
`
` Q. Q.
` (Pause in proceedings.)
` BY MR. MALIK:
`
` Q. Q. Let me also hand you what I have marked
`
` Q. Q.
`InnoPharma Exhibit 1067.
` Dr. Williams, you were deposed in this
`case in connection with the corresponding district
`court litigation. Is that correct?
`
` A. A. I've been deposed twice in this case.
`
` A. A.
`
` Q. Q. A couple weeks ago?
`
` Q. Q.
`
` A. A. Yes.
`
` A. A.
`
` Q. Q. Okay. And that deposition was -- the
`
` Q. Q.
`transcript right there -- is that the deposition
`transcript there? Is that the testimony that you
`gave in connection with the district court case you
`gave a couple weeks ago?
`
` A. A. It appears to be. Yes.
`
` A. A.
`
` Q. Q. Okay. And during that deposition you were
`
` Q. Q.
`sworn. Correct?
`
` A. A. Yes.
`
` A. A.
`
` Q. Q. And do you stand by the statements in that
`
` Q. Q.
`declaration?
`
`GregoryEdwards, LLC | Worldwide Court Reporting
`GregoryEdwards.com | 866-4Team GE
`
`Page 5
`
`

`
`Confidential - Subject to The Protective Order
`Robert O. Williams, III, Ph.D. - March 9, 2016
`
`Page 18
`
`
` A. A. I do.
`
` A. A.
`
` Q. Q. I'm sorry. In the deposition transcript.
`
` Q. Q.
`
` A. A. In this deposition, I do stand by what I
`
` A. A.
`said. Yes.
`
` Q. Q. Thank you. Let me hand you what has
`
` Q. Q.
`previously been marked as Senju Exhibit 2115.
` Dr. Williams, do you recognize Senju
`Exhibit 2115?
`
` A. A. It is -- Exhibit 2115 is a copy of my
`
` A. A.
`curriculum vitae that was current at the time that
`I -- that this went in.
`
` Q. Q. Are there any differences or any changes
`
` Q. Q.
`that you'd like to make since the date you submitted
`your declaration?
`
` A. A. Well, the -- I mean, the parts that would
`
` A. A.
`change that I continually update are the patent
`section and the publication section, the poster
`section.
`
` Q. Q. Okay.
`
` Q. Q.
`
` A. A. And I actually don't quite remember the
`
` A. A.
`date, but I'm sure there's some additions to that.
`
` Q. Q. Fair enough.
`
` Q. Q.
`
`Page 19
`
` You have an appointment to the College
`of Pharmacy. Correct?
`
` A. A. Yes.
`
` A. A.
`
` Q. Q. Not to the Department of Chemistry.
`
` Q. Q.
`
` A. A. That's correct.
`
` A. A.
`
` Q. Q. Will you turn to page 2 of Senju
`
` Q. Q.
`Exhibit 2115. Under Classes Taught, Section IV, you
`teach no classes in the Department of Chemistry.
`Correct?
`
` A. A. That's true.
`
` A. A.
`
` Q. Q. Also on pages 2 through 3 under
`
` Q. Q.
`"Professional" -- under "Professional Memberships,"
`I do not see any membership to any chemical society
`or chemical association. Is that correct?
`
` A. A. I mean, what's listed in Section V is what
`
` A. A.
`I belong to, and there's not one -- the only one I
`know of is American Chemical Society, and I'm not a
`member of that.
`
` Q. Q. So you're not a member of the ACS.
`
` Q. Q.
`
` A. A. I'm not.
`
` A. A.
`
` Q. Q. If you turn to page 3, it talks about your
`
` Q. Q.
`"Current Research Interests."
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`
`6 (Pages 18 to 21)
`
`Page 20
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`
` Do you see that? It's under
`Section VI.
`
` A. A. Yes.
`
` A. A.
`
` Q. Q. It lists pulmonary, nasal, and buccal.
`
` Q. Q.
` Do you see that?
`
` A. A. I see that.
`
` A. A.
`
` Q. Q. Okay. There's no reference to ophthalmic
`
` Q. Q.
`solutions there. Correct?
`
` A. A. In this section with this copy there is
`
` A. A.
`not.
`
` Q. Q. Okay. That's not one of your research
`
` Q. Q.
`focuses.
`
` A. A. I -- I study -- these often involve
`
` A. A.
`solution formulations and suspension formulations
`especially the one for the inhalation and nasal.
` So the characteristics are the same,
`but my application at the current time is not
`necessarily for the eye but for the lungs and nasal.
` So the properties of the materials, I
`mean, to me -- to a person of skill in the art would
`be quite similar.
`
` Q. Q. Okay. Under "Editorial Responsibilities,"
`
` Q. Q.
`
`Page 21
`
`that would be on page 6 -- 5 of 60. I don't see any
`chemical journals listed there; mostly
`pharmaceutical journals. Is that fair?
`
` A. A. That's -- yeah. I mean, these are the
`
` A. A.
`journals that I have reviewed for or served some
`kind of an editorial editorship or -- and I don't
`think -- there's one that -- I mean, the one I know
`is from AC -- one of the journals from the American
`Chemical Society, and I don't think I've reviewed
`for them.
`
` Q. Q. Okay. You haven't formulated with ascetic
`
` Q. Q.
`drug and BAC. Is that correct?
` MR. HASFORD: Objection. Vague and
`ambiguous.
`
` A. A. Sitting right here, I don't recall.
`
` A. A.
` BY MR. MALIK:
`
` Q. Q. So you don't ever recall formulating with
`
` Q. Q.
`an acetic NSAID and BAC.
` MR. HASFORD: Same objection.
`
` A. A. I mean, I've worked with NSAIDs, but I
`
` A. A.
`don't recall formulating them with benzalkonium
`chloride --
`
`GregoryEdwards, LLC | Worldwide Court Reporting
`GregoryEdwards.com | 866-4Team GE
`
`Page 6
`
`

`
`Confidential - Subject to The Protective Order
`Robert O. Williams, III, Ph.D. - March 9, 2016
`
`Page 22
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`
` BY MR. MALIK:
`
` Q. Q. Yeah.
`
` Q. Q.
`
` A. A. -- sitting here.
`
` A. A.
`
` Q. Q. Have you worked with diclofenac?
`
` Q. Q.
`
` A. A. I have. Yes.
`
` A. A.
`
` Q. Q. Have you worked with bromfenac?
`
` Q. Q.
`
` A. A. No.
`
` A. A.
`
` Q. Q. Have you worked with ketorolac?
`
` Q. Q.
`
` A. A. Yes.
`
` A. A.
`
` Q. Q. Have you worked with polysorbate 80 before?
`
` Q. Q.
`
` A. A. Yes.
`
` A. A.
`
` Q. Q. In what context?
`
` Q. Q.
`
` A. A. For -- I do a lot of work in solubilization
`
` A. A.
`of water-insoluble drugs, and so polysorbate 80 is
`one of the non-ionic surfactants that I've looked at
`in solubilization and trying to control
`precipitation into making small particles.
` So -- and then I've looked at it in
`solution formulations as a wetting agent. So that's
`generally the context.
`
` Q. Q. Have you ever -- you have ever worked with
`
` Q. Q.
`tyloxapol before. Correct?
`
`Page 23
`
`1
`
` A. A. Yes.
`
` A. A.
`2
`
` Q. Q. Have you ever worked with tyloxapol in
`
` Q. Q.
`3 connection with NSAID?
`4
`
` A. A. I may have. With either the ketorolac or
`
` A. A.
`5 the diclofenac. I may have.
`6
`
` Q. Q. Ever worked with polyvinylpyrrol?
`
` Q. Q.
`7
`
` A. A. I'm sorry?
`
` A. A.
`8
`
` Q. Q. Polyvinylpyrrol. PVP.
`
` Q. Q.
`9
`
` A. A. Polyvinylpyrrolidone?
`
` A. A.
`10
`
` Q. Q. Yes. I'm sorry.
`
` Q. Q.
`11
`
` A. A. That's all right.
`
` A. A.
`12 I have. Yes.
`13
`
` Q. Q. Have you worked with sodium sulfite?
`
` Q. Q.
`14
`
` A. A. A long time ago I have. I haven't
`
` A. A.
`15 recently, but yes, I have.
`16
`
` Q. Q. Ever worked with BHT?
`
` Q. Q.
`17
`
` A. A. Butylated hydroxytoluene?
`
` A. A.
`18
`
` Q. Q. Yes.
`
` Q. Q.
`19
`
` A. A. Yes. I have.
`
` A. A.
`20
`
` Q. Q. What's the function of BHT?
`
` Q. Q.
`21 MR. HASFORD: Objection. Vague and
`22 ambiguous.
`
`7 (Pages 22 to 25)
`
`Page 24
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`
`
` A. A. In the examples that I was working with
`
` A. A.
`BHT, it was there as a stabilizer for the active
`ingredient.
` BY MR. MALIK:
`
` Q. Q. How do you stabilize the active ingredient?
`
` Q. Q.
`
` A. A. In -- I think it was against oxidation in
`
` A. A.
`the particular example that I was using it.
`
` Q. Q. In connection with your work you use
`
` Q. Q.
`Remington's. Correct?
`
` A. A. Yes.
`
` A. A.
`
` Q. Q. How often do you use it?
`
` Q. Q.
`
` A. A. It's -- Remington's is one of the
`
` A. A.
`references that -- that I have. And I use -- and I
`consult with several references like Remington's,
`but I use it quite frequently.
`
` Q. Q. Do you also consult the Merck Index?
`
` Q. Q.
`
` A. A. Not so much.
`
` A. A.
`
` Q. Q. What about the Handbook of Pharmaceutical
`
` Q. Q.
`Excipients?
`
` A. A. I do. Yes.
`
` A. A.
`
` Q. Q. Do you have a copy of Remington's?
`
` Q. Q.
`
` A. A. I do. Yeah.
`
` A. A.
`
`Page 25
`
`
` Q. Q. Do you have a copy of the Handbook of
`
` Q. Q.
`Pharmaceutical Excipients?
`
` A. A. Yes.
`
` A. A.
`
` Q. Q. Turn to page -- Paragraph 4 of your
`
` Q. Q.
`declaration that is exhibit -- again, this is the
`902 case, Senju Exhibit 2082.
`
` A. A. Okay.
`
` A. A.
`
` Q. Q. It says you have experience with ophthalmic
`
` Q. Q.
`dosage forms including solutions.
` Do you see that?
`
` A. A. Yes.
`
` A. A.
`
` Q. Q. What is the nature of your experience?
`
` Q. Q.
`
` A. A. I have worked on ophthalmic -- there was an
`
` A. A.
`ophthalmic suspension, developing the formulation
`for it at one point.
`
` Q. Q. Do you recall the active pharmaceutical
`
` Q. Q.
`ingredient?
`
` A. A. I'm under a confidentiality agreement with
`
` A. A.
`that, so I do recall it, but ...
`
` Q. Q. Perhaps I can ask it a different way.
`
` Q. Q.
` I assume the active pharmaceutical --
`was the active pharmaceutical agreement an NSAID?
`
`GregoryEdwards, LLC | Worldwide Court Reporting
`GregoryEdwards.com | 866-4Team GE
`
`Page 7
`
`

`
`Confidential - Subject to The Protective Order
`Robert O. Williams, III, Ph.D. - March 9, 2016
`
`Page 26
`
`
` A. A. It was not.
`
` A. A.
`
` Q. Q. Can you disclose what kind of compound,
`
` Q. Q.
`generally speaking, it is?
`
` A. A. It was antihistamine-type drug.
`
` A. A.
`
` Q. Q. Okay. Did the formulation include BAC?
`
` Q. Q.
`
` A. A. You know, it's been a while. I don't
`
` A. A.
`recall.
`
` Q. Q. Okay. Can you disclose when you were
`
` Q. Q.
`working on this formulation?
` And I'm not asking you to breach any
`confidentiality --
`
` A. A. Sure.
`
` A. A.
`
` Q. Q. -- obligation.
`
` Q. Q.
`
` A. A. I mean, it's been at least ten years. I
`
` A. A.
`actually don't remember. It's been a few years. I
`say ten because it's not in my -- it's been a while.
`
` Q. Q. Other than this one example -- other than
`
` Q. Q.
`the example you just gave us, do you recall any
`other ophthalmic dosage forms that you formulated?
`
` A. A. Yes, I do.
`
` A. A.
`
` Q. Q. What were those other dosage forms?
`
` Q. Q.
`
` A. A. That -- well, the one I just said with the
`
` A. A.
`
`Page 27
`
`antihistamine, as I recall, is a suspension.
` The next one was a solution.
`
` Q. Q. Okay. What was the nature of the active
`
` Q. Q.
`pharmaceutical ingredient?
`
` A. A. That one was sildenafil citrate.
`
` A. A.
` I was working with an ophthalmologist
`at one of our medical schools.
`
` Q. Q. Did that formulation have BAC in it?
`
` Q. Q.
`
` A. A. I don't recall.
`
` A. A.
`
` Q. Q. Other than the two examples you just gave,
`
` Q. Q.
`are there any other examples?
`
` A. A. Not that I recall sitting here.
`
` A. A.
`
` Q. Q. And the second example -- because I can't
`
` Q. Q.
`pronounce because the realtime is not working --
`when was that?
` When did you make that formulation?
`
` A. A. That was -- it was sometime in the early
`
` A. A.
`2000s.
`
` Q. Q. Okay. Let's see.
`
` Q. Q.
` In your declaration you have a section
`on "Information Considered."
` I direct you to Paragraph 12.
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`
`8 (Pages 26 to 29)
`
`Page 28
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`
`
` A. A. Okay.
`
` A. A.
`
` Q. Q. In connection with your declaration in the
`
` Q. Q.
`IPR you rely on the declaration of Dr. Davies. Is
`that correct?
`
` A. A. Yes.
`
` A. A.
`
` Q. Q. And also Dr. Myers. Is that correct?
`
` Q. Q.
`
` A. A. Yes.
`
` A. A.
`
` Q. Q. Sawa?
`
` Q. Q.
`
` A. A. Yes.
`
` A. A.
`
` Q. Q. And Mr. Paulson?
`
` Q. Q.
`
` A. A. Yes.
`
` A. A.
`
` Q. Q. Did you speak to any of these individuals?
`
` Q. Q.
`
` A. A. I have not.
`
` A. A.
`
` Q. Q. Have you read any of their deposition
`
` Q. Q.
`transcripts?
`
` A. A. Yes, I have.
`
` A. A.
`
` Q. Q. Which ones?
`
` Q. Q.
`
` A. A. Oh, wait. Let's see. Deposition
`
` A. A.
`transcripts?
`
` Q. Q. We can break it down.
`
` Q. Q.
` Have you read Dr. Davies -- have you
`read any deposition transcripts from Dr. Davies?
`
`Page 29
`
`
` A. A. I don't think I have.
`
` A. A.
`
` Q. Q. Okay.
`
` Q. Q.
`
` A. A. I don't recall.
`
` A. A.
`
` Q. Q. What about from Dr. Myers?
`
` Q. Q.
`
` A. A. I don't recall reviewing -- or reading his
`
` A. A.
`deposition transcript.
`
` Q. Q. Mr. Sawa?
`
` Q. Q.
`
` A. A. I don't recall, sitting here.
`
` A. A.
` I mean, if I've cited to it in my --
`cited any of their deposition transcripts, it would
`be in my report. I just don't -- it doesn't stand
`out right now, sitting here.
`
` Q. Q. And just for completion Mr. Paulson --
`
` Q. Q.
`Dr. Paulson. I'm sorry.
` Do you recall Dr. Paulson's -- reading
`a deposition transcript from Dr. Paulson?
`
` A. A. I do not.
`
` A. A.
`
` Q. Q. So the opinions in connection with your
`
` Q. Q.
`declaration labeled Senju Exhibit 2082 are based on
`the declarations submitted by Dr. Davies,
`Dr. Paulson, Dr. Myers, and Mr. Sawa. Is that fair?
` MR. HASFORD: Objection to the extent
`
`GregoryEdwards, LLC | Worldwide Court Reporting
`GregoryEdwards.com | 866-4Team GE
`
`Page 8
`
`

`
`Confidential - Subject to The Protective Order
`Robert O. Williams, III, Ph.D. - March 9, 2016
`
`Page 30
`
`it mischaracterizes the witness's testimony.
`
` A. A. Unless I particularly cited to a passage
`
` A. A.
`from their deposition, I definitely relied on
`their -- on their declarations or expert reports.
` BY MR. MALIK:
`
` Q. Q. Okay. If I can direct your attention to
`
` Q. Q.
`Paragraph 45 of your declaration, you make reference
`to Dr. Laskar.
` Do you see that? 45 and 46.
`
` A. A. Yes.
`
` A. A.
`
` Q. Q. I assume in connection with your
`
` Q. Q.
`declaration you read Dr. Laskar's deposition -- I
`mean, declaration. I'm sorry.
`
` A. A. I did. Yes.
`
` A. A.
`
` Q. Q. Did you review his deposition transcript?
`
` Q. Q.
`
` A. A. Sitting here right now, I don't recall.
`
` A. A.
`But if I've cited to it in my report, then I have
`seen it. I just don't remember sitting here.
`
` Q. Q. Okay. Let me turn your attention to
`
` Q. Q.
`Section C which is on the same page, 18 of 126, in
`Senju Exhibit 2082 which addresses -- which is
`labeled "Claim Construction for 'Stable' and 'Amount
`
`Page 31
`
`Sufficient to Stabilize.'"
` Do you see that?
`
` A. A. Yes.
`
` A. A.
`
` Q. Q. Why did you include this section in your
`
` Q. Q.
`declaration?
`
` A. A. To give background on what the Court had
`
` A. A.
`decided for "Stable" and "Amount Sufficient to
`Stabilize."
`
` Q. Q. In rendering your opinion as contained in
`
` Q. Q.
`your declaration, did you use these constructions?
` MR. HASFORD: Objection. It's vague
`and ambiguous.
` BY MR. MALIK:
`
` Q. Q. And please feel free to look at your
`
` Q. Q.
`report, however you wish.
`
` A. A. I mean, my opinion is consistent with how
`
` A. A.
`the Court has construed "Stable" and "in an amount
`Sufficient to Stabilize" in the context of the '290
`patent and the other patents-in-suit.
`
` Q. Q. Have you ever heard of the term "broadest
`
` Q. Q.
`reasonable construction"?
` MR. HASFORD: Object to the extent it
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`
`9 (Pages 30 to 33)
`
`Page 32
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`
`calls for a legal conclusion.
`
`
` A. A. I mean, I've heard it before. I don't --
`
` A. A.
`I'm not an attorney. I'm not sure I understand the
`
`full meaning of it, but I have heard it before.
`
` BY MR. MALIK:
`
`
` Q. Q. In what context, have you heard it before?
`
` Q. Q.
`
` A. A. Just in working with patents. That's the
`
` A. A.
`context.
`
`
` Q. Q. Do you know if there's any discussion of
`
` Q. Q.
`the broadest reasonable construction in your
`
`declaration marked Senju Exhibit 2082?
`
`
` A. A. I don't believe there is, but -- anyway,
`
` A. A.
`not that I'm aware of.
`
`
` Q. Q. Let me direct your attention to
`
` Q. Q.
`Paragraph 52 of your report. And please feel free
`
`to read the paragraph while we get the exhibit.
`
` Let me hand you what has been marked as
`
`Exhibit 2014.
`
` Dr. Williams, is Exhibit 2014 what is
`
`cited in Paragraph 53?
`
`
` A. A. Oh, I'm on 52.
`
` A. A.
`
` Q. Q. I'm sorry. 53 of your declaration.
`
` Q. Q.
`
`Page 33
`
`
` A. A. It is. Yes.
`
` A. A.
`
` Q. Q. Exhibit 2014 is the Rowe patent. Is that
`
` Q. Q.
`correct?
`
` A. A. Yes. That's right.
`
` A. A.
`
` Q. Q. And you cited it for the proposition of
`
` Q. Q.
`sodium sulfite is a well-known antioxidant.
` Do you see that?
`
` A. A. Yes.
`
` A. A.
`
` Q. Q. Can I -- can you please turn your attention
`
` Q. Q.
`to column 3, line 41.
`
` A. A. Okay.
`
` A. A.
`
` Q. Q. Do you see that this patent also identifies
`
` Q. Q.
`that, "The formulation may also contain a
`preservative, for example, benzalkonium
`chloride ..."?
`
` A. A. I mean, in this passage that I cite,
`
` A. A.
`there's several preservatives that are mentioned.
`Benzalkonium chloride is one of them. Plus a list
`here.
`
` Q. Q. Okay. Is there any discussion here about
`
` Q. Q.
`any dangers associated with benzalkonium chloride?
`
` A. A. Not in that passage. It's just listing
`
` A. A.
`
`GregoryEdwards, LLC | Worldwide Court Reporting
`GregoryEdwards.com | 866-4Team GE
`
`Page 9
`
`

`
`Confidential - Subject to The Protective Order
`Robert O. Williams, III, Ph.D. - March 9, 2016
`
`Page 34
`
`what a formulation m