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` UNITED STATES PATENT AND TRADEMARK OFFICE
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`MYLAN PHARMACEUTICALS, *
`INC., CELLTRION, INC., *
`AND APOTEX, INC., * CASE IPR2021-00880
` *
`PETITIONERS, * PATENT 9,669,069 B2
` *
`VS. *
` * CASE IPR2021-00881
`REGENERON *
`PHARMACEUTICALS, INC., * PATENT 9,254,338 B2
` *
`PATENT OWNER. *
`
` ******************************************
` ORAL AND VIDEOTAPED DEPOSITION OF
` DAVID M. BROWN, M.D.
` APRIL 26, 2022
` ******************************************
`
` ORAL AND VIDEOTAPED DEPOSITION OF DAVID M.
`BROWN, M.D., produced as a witness at the instance
`of the PETITIONERS, and duly sworn, was taken in
`the above-styled and numbered cause on APRIL 26,
`2022, from 9:07 A.M. to 3:03 P.M., before AMY
`PRIGMORE, CSR, in and for the State of Texas,
`reported by stenographic means, at the offices of
`Arnold & Porter Kaye Scholer LLP, 700 Louisiana St,
`Suite 4000, Houston, Texas, pursuant to the Federal
`Rules of Civil Procedure and the provisions stated
`on the record or attached hereto.
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`www.veritext.com
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`888-391-3376
`
`Veritext Legal Solutions
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`Mylan Exhibit 1110
`Mylan v. Regeneron, IPR2021-00880
`Page 1
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`
`
` UNITED STATES PATENT AND TRADEMARK OFFICE
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`MYLAN PHARMACEUTICALS, *
`INC., CELLTRION, INC., *
`AND APOTEX, INC., * CASE IPR2021-00880
` *
`PETITIONERS, * PATENT 9,669,069 B2
` *
`VS. *
` * CASE IPR2021-00881
`REGENERON *
`PHARMACEUTICALS, INC., * PATENT 9,254,338 B2
` *
`PATENT OWNER. *
`
` ******************************************
` ORAL AND VIDEOTAPED DEPOSITION OF
` DAVID M. BROWN, M.D.
` APRIL 26, 2022
` ******************************************
`
` ORAL AND VIDEOTAPED DEPOSITION OF DAVID M.
`BROWN, M.D., produced as a witness at the instance
`of the PETITIONERS, and duly sworn, was taken in
`the above-styled and numbered cause on APRIL 26,
`2022, from 9:07 A.M. to 3:03 P.M., before AMY
`PRIGMORE, CSR, in and for the State of Texas,
`reported by stenographic means, at the offices of
`Arnold & Porter Kaye Scholer LLP, 700 Louisiana St,
`Suite 4000, Houston, Texas, pursuant to the Federal
`Rules of Civil Procedure and the provisions stated
`on the record or attached hereto.
`
`www.veritext.com
`
`888-391-3376
`
`Veritext Legal Solutions
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`Mylan Exhibit 1110
`Mylan v. Regeneron, IPR2021-00880
`Page 1
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`Page 2
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` A P P E A R A N C E S
`
`F O R T H E P E T I T I O N E R S :
` H e i n z J . S a l m e n
` S c o t t B e a l l P h . D .
` R a k o c z y M o l i n o M a z z o c h i S i w i k L L P
` 6 W H u b b a r d S t , S u i t e 5 0 0
` C h i c a g o I L 6 0 6 5 4 - 4 6 1 6
` h s a l m e n @ r m m s l e g a l . c o m
` s b e a l l @ r m m s l e g a l . c o m
` 3 1 2 - 2 2 2 - 7 5 0 4
` 3 1 2 - 2 2 2 - 5 1 0 7
`
` V i n n y L e e
` I N - H O U S E C O U N S E L ( v i a p h o n e )
`
`F O R T H E R E S P O N D E N T :
` D e b o r a h F i s h m a n
` A r n o l d & P o r t e r
` 3 0 0 0 E l C a m i n o R e a l , S u i t e 5 0 0
` F i v e P a l o A l t o S q u a r e
` P a l o A l t o C A 9 4 3 0 6
` D e b o r a h . f i s h m a n @ a r n o l d p o r t e r . c o m
`
` J e r e m y C o b b
` A r n o l d & P o r t e r
` 6 0 1 M a s s a c h u s e t t s A v e N W
` W a s h i n g t o n D C 2 0 0 0 1
` j e r e m y . c o b b @ a r n o l d p o r t e r . c o m
` ( 2 0 2 ) 9 4 2 - 6 8 2 8
` J a m e s E v a n s
` E i l e e n W o o
` P e t r a S c a m b o r o v a ( v i a p h o n e )
` I N - H O U S E C O U N S E L
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`A L S O P R E S E N T :
` J o n a t h a n C u r r a n , V i d e o g r a p h e r
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`Veritext Legal Solutions
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`Mylan Exhibit 1110
`Mylan v. Regeneron, IPR2021-00880
`Page 2
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`
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`Page 3
`
` INDEX
` PAGE
`APPEARANCES ................................. 2
`STIPULATIONS ................................ 1
`SIGNATURE AND CHANGES ....................... 172
`REPORTER'S CERTIFICATE....................... 174
`
` E X A M I N A T I O N S
` DAVID M. BROWN, M.D. PAGE
` EXAMINATION 6
` BY MR. SALMEN
` EXAMINATION 167
` BY MS. FISHMAN
`
` E X H I B I T S
`
` EXHIBIT DESCRIPTION PAGE
` EXHIBIT 1 PETITIONER'S NOTICE OF 7
` DEPOSITION OF DAVID M.
` BROWN, M.D.
` EXHIBIT 2 PETITIONER'S NOTICE OF 7
` DEPOSITION OF DAVID
` BROWN, M.D.
` EXHIBIT 3 DO DEPOSITION EXHIBIT 4 24
` EXHIBIT 4 TRIAL RECORD OF NCT 64
` 00509795, FROM
` CLINICALTRIALS.GOV
` EXHIBIT 5 VIEW 2 NCT 377, FROM 64
` CLINICALTRIALS.GOV
` EXHIBIT 6 EXCERPT OF MYLAN 71
` EXHIBIT 1017, PAGES 283
` THROUGH 292
` EXHIBIT 7 PROSECUTION HISTORY 101
` EXHIBIT 8 LETTER TO THE EDITOR 113
` TITLED: RANIBIZUMAB FOR
` DIABETIC MACULAR EDEMA
` EXHIBIT 9 L36962 DOCUMENT 127
` EXHIBIT 10 ASRS FIGHTS NOVITAS 132
` DECISION TO INTERPRET
` EYLEA USAGE MORE
` FREQUENTLY THAN Q8 AS
` OFF-LABEL
` EXHIBIT 11 L36962, MEDICARE PART A, 135
` B, LOCAL COVERAGE
` DETERMINATION, LCD,
` COMMENT SUMMARY
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`Veritext Legal Solutions
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`Mylan Exhibit 1110
`Mylan v. Regeneron, IPR2021-00880
`Page 3
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`Page 4
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` EXHIBIT 12 SEPTEMBER 2017 DOCUMENT 144
` TITLED, TREATMENT
` PARADIGMS IN AMD
` MANAGEMENT, ASSESSING
` CONSISTENT LONG-TERM
` DOSING
` EXHIBIT 13 DOCUMENT TITLED, QUOTE: 155
` RANDOMIZED TRIAL OF
` TREAT AND EXTEND VERSUS
` MONTHLY DOSING FOR
` NEOVASCULAR AGE-RELATED
` MACULAR DEGENERATION
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`Veritext Legal Solutions
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`Mylan Exhibit 1110
`Mylan v. Regeneron, IPR2021-00880
`Page 4
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` P R O C E E D I N G S
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` * * *
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` THE VIDEOGRAPHER: Good morning. We
`
`are going on the record at 9:07 a.m., on
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`April 26th, 2022. This is Media Unit No. 1 of the
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`video recorded deposition of Dr. Brown, taken by
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`counsel for the Petitioner, in the matter of Mylan
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`Pharmaceuticals versus Regeneron Pharmaceuticals,
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`filed in the Patent Trial and Appeal Board, Case
`
`No. IPR 2021-00881.
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` This deposition is being held at
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`Arnold & Porter Kaye Scholer, LLP, located at 700
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`Louisiana Street, Suite 4000, Houston, Texas.
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` My name is Jonathan Curran. I'm
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`with the firm Veritext. I'm the videographer. The
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`court reporter is Amy Prigmore, from the firm
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`Veritext.
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` Now, if everybody present, counsel,
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`could state their appearances, starting with my
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`left.
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` MR. SALMEN: Heinz Salmen, of RMMS,
`
`in Chicago, on behalf of Mylan, Petitioner.
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` Joining me in -- in person here is
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`Scott Beall, also of RMMS, on behalf of the
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`Petitioner. And on the conference line, Vinny Lee
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`Mylan Exhibit 1110
`Mylan v. Regeneron, IPR2021-00880
`Page 5
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`of Regeneron, on behalf of Petitioner, Mylan.
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` MS. FISHMAN: Good morning. Deborah
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`Fishman, of Arnold & Porter, on behalf of patent
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`owner, Regeneron, and on behalf of the witness.
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` With me today is Jeremy Cobb, also
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`of Arnold & Porter, on behalf the Regeneron, patent
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`owner. And with us present in the room today,
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`James Evans and Eileen Woo, both in-house counsel
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`of Regeneron.
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` And one clarification on the
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`caption, our understanding is that this deposition
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`is taking place in both IPR 2021-00881, as well as
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`2021-00880, for both proceedings.
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` THE VIDEOGRAPHER: And may the court
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`reporter now swear in the witness.
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` DAVID M. BROWN, M.D.,
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`having been first duly sworn, testified as follows:
`
` EXAMINATION
`
`BY MR. SALMEN:
`
` Q. Good morning, Dr. Brown.
`
` A. Good morning.
`
` Q. In front of you, I -- I placed a few
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`documents. First is what's been previously marked
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`Exhibit 2050. That's the stapled paper there.
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` Do you see it?
`
`www.veritext.com
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`888-391-3376
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`Veritext Legal Solutions
`
`Mylan Exhibit 1110
`Mylan v. Regeneron, IPR2021-00880
`Page 6
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`
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` A. Yes, sir.
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` Q. Do you recognize this as a copy of your
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`expert declaration --
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` A. Absolutely.
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` Q. -- in the -- okay.
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` And if you could please turn to the last
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`page there, and confirm that that's your signature?
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` A. It is.
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` Q. Okay. I've also provided you with a couple
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`binders. I'm not going to go through them now, but
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`those include, I believe, the majority, if not all
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`of the exhibits that you cite in your declaration.
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`So to the extent you need any of them, you're -- go
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`ahead and look at those.
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` A. Perfect.
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` Q. Now I'm going to hand you what I've marked
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`as Brown Exhibit 1.
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` (Exhibit 1 is marked.)
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` Q. (BY MR. SALMEN) And Brown Exhibit 2.
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` (Exhibit 2 is marked.)
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` Q. (BY MR. SALMEN) Brown Exhibit 1 is
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`Petitioner's Notice of Deposition of David M.
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`Brown, M.D. And Brown Exhibit 2 is Petitioner's
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`Notice of Deposition of David Brown, M.D.
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` Dr. Brown, is it your understanding that
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`Mylan Exhibit 1110
`Mylan v. Regeneron, IPR2021-00880
`Page 7
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`you're being deposed today pursuant to these
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`notices?
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` A. Yes, sir.
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` Q. And you understand that there are two
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`proceedings pending before the United States Patent
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`and Trademark Office?
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` A. That's what I've been told.
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` Q. The first proceeding is IPR 2021-00881,
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`pertaining to what I'll refer to as the
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`'338 patent.
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` Is that okay?
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` A. Correct.
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` Q. And the second proceeding is IPR 2021-00880,
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`pertaining to what I'll refer to as the
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`'069 patent.
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` Is that okay?
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` A. Sure.
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` Q. And, Dr. Brown, you understand that the
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`declaration that you prepared for these
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`proceedings, Exhibit 2050, represents your direct
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`examination in these proceedings?
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` A. Correct.
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` Q. And do you understand that the questions
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`I'll be asking you today represent your
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`cross-examination testimony?
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`Mylan Exhibit 1110
`Mylan v. Regeneron, IPR2021-00880
`Page 8
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`Page 9
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` A. Correct.
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` Q. You ever been cross-examined?
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` A. For a med mal, as defense, so...
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` Q. Okay. Did that appear in an in-court
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`cross-examination proceeding?
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` A. It was all video.
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` Q. Okay. All right. Dr. Brown, let's look at
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`your declaration.
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` I'm going to start at paragraph 12.
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` A. Paragraph 12.
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` Q. This is in the section that you titled, A
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`Person of Ordinary Skill in the Art.
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` Do you see that?
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` A. Yes, sir.
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` Q. And here, you state that you, quote: Have
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`been asked to consider the level of ordinary skill
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`in the art, as it relates to the earliest effective
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`filing date of the '338 patent and '069 patent.
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` Do you see that?
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` A. Yes.
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` Q. Now, for context, I'd like to look at your
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`legal standards section, beginning at paragraph 16,
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`on the next page.
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` And this section is the -- from paragraph 16
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`to paragraph 25.
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`Mylan Exhibit 1110
`Mylan v. Regeneron, IPR2021-00880
`Page 9
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` Is that correct?
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` A. That's correct.
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` Q. And these are the legal standards that you
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`applied in forming your opinions, that are set
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`forth in your declaration, Exhibit 2050.
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` Is that correct?
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` A. Yes, with help of counsel.
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` Q. You applied the legal standards, though --
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` A. I did --
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` Q. -- in forming your opinion --
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` A. -- they helped me define the legal
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`standards. I went to med -- medical school, not
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`law school.
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` Q. I understand that.
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` And just for the sake of the court reporter,
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`Dr. Brown, if we can try not to talk over each
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`other. Okay. So, I -- I just ask you to allow me
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`to finish my question, and then give your counsel
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`an opportunity to object, if she needs to, and then
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`answer it.
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` Is that okay?
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` A. It's okay.
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` Q. Thank you.
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` Now, turning back to your paragraph 12, in
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`your declaration. You state, at the last sentence,
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`www.veritext.com
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`888-391-3376
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`Veritext Legal Solutions
`
`Mylan Exhibit 1110
`Mylan v. Regeneron, IPR2021-00880
`Page 10
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`quote: I have been informed and understand that
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`the earliest filing date of the '338 patent and
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`'069 patent is January 13th, 2011.
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` Do you see that?
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` A. I do.
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` Q. And is that the date that you applied in
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`forming your opinions that are set forth in your
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`declaration?
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` A. It is.
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` Q. Now, the rest of your section titled, The
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`Person of Ordinary Skill in the Art, you do not
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`provide your own definition for a person of
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`ordinary skill in the art.
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` Is that correct?
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` A. That is correct.
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` Q. Instead, in paragraph 14 of your
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`declaration, you provide your understanding of
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`Regeneron's and Dr. Do's definition for a person of
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`ordinary skill in the art.
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` Is that correct?
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` A. That is correct.
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` Q. Then, in paragraph 13, you replicate the
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`Petitioner's definition for a person of ordinary
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`skill in the art.
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` Is that correct?
`
`www.veritext.com
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`888-391-3376
`
`Veritext Legal Solutions
`
`Mylan Exhibit 1110
`Mylan v. Regeneron, IPR2021-00880
`Page 11
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`
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`Page 12
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` A. That is correct.
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` Q. Okay. Do you agree that these are two
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`different definitions for the person of ordinary
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`skill in the art, in the '338 and '069 patents?
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` MS. FISHMAN: Objection; calls for a
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`legal conclusion.
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` You can answer.
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` A. Yeah, I to law school, not medical school.
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`I'll defer to counsel.
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` Q. (BY MR. SALMEN) I'm asking you to answer
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`the question.
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` Do you believe that these are different
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`definitions for the person of ordinary skill in the
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`art?
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` A. They're different wording; one's expanded.
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`So, yes, they are different wording.
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` Q. Okay. I'm going to hand you what's been
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`marked previously as Exhibit 2051.
`
` (Voices en sotto.)
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` Q. (BY MR. SALMEN) Dr. Brown, do you recognize
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`Exhibit 2051?
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` A. I do.
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` Q. This is the declaration of Dr. Do.
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` Is that correct?
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` A. That's correct.
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`Mylan Exhibit 1110
`Mylan v. Regeneron, IPR2021-00880
`Page 12
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`Page 13
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` Q. Okay. Let's look at her paragraph 28.
`
`Dr. Do states that, quote: In the event Mylan
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`argues that the skilled artisan need not be a
`
`licensed physician (ophthalmologist), close quote,
`
`she disagrees.
`
` Do you see that?
`
` A. I see that.
`
` Q. Do you agree with Dr. Do's opinion in
`
`paragraph 28 of her declaration?
`
` A. I didn't offer an opinion in my declaration.
`
` Q. Do you agree with Dr. Do's opinion that is
`
`set forth in paragraph 28, of her declaration?
`
` A. I concur with her opinion.
`
` Q. Okay. Now, let's look back at your
`
`paragraph 13, where you recite Mylan's definition.
`
` You see that Mylan's definition does not
`
`require that the skilled artisan be a licensed
`
`ophthalmologist.
`
` Is that correct?
`
` A. That is correct.
`
` Q. Okay. Now, I want you to turn to the
`
`section in Dr. Do's declaration that she titles,
`
`Legal Framework, beginning around paragraph 19.
`
` And before I proceed on -- on this point,
`
`Dr. Brown, you did review Dr. Do's declaration.
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`Mylan Exhibit 1110
`Mylan v. Regeneron, IPR2021-00880
`Page 13
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`Page 14
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` A. I did.
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` Q. Okay. Paragraph 20, Dr. Do states, quote:
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`I have been informed that the patent claims are
`
`construed from the -- excuse me.
`
` I'm going to strike that and restart.
`
` Dr. Do states, in paragraph 20 of her
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`declaration, quote: I have been informed that
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`patent claim terms are construed from the vantage
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`point of a skilled artisan to which the invention
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`relates at the time of the invention (or as of the
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`effective filing dates of the patent application.)
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` The skilled artisan, I understand, is
`
`presumed to be familiar with what was known in the
`
`art at the time.
`
` Do you see that?
`
` A. I see that.
`
` Q. Does that paragraph reflect your
`
`understanding, as well, for how patent claims are
`
`termed to be construed?
`
` MS. FISHMAN: Objection; lacks
`
`foundation.
`
` You can answer.
`
` A. I'm -- I'm not a patent attorney, but that
`
`is my -- I concur with that.
`
` Q. (BY MR. SALMEN) Okay. So your -- your
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`Mylan Exhibit 1110
`Mylan v. Regeneron, IPR2021-00880
`Page 14
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`Page 15
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`attorney just objected for my question lacking
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`foundation.
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` Is it true that you do not offer any of your
`
`own opinions regarding claim construction for
`
`the -- the terms of the '338 patent?
`
` A. So, we discuss that in my declaration.
`
` Q. Okay. Why don't we turn to paragraph 97 of
`
`your declaration.
`
` Is this the section of your declaration that
`
`you were referring to?
`
` A. One of them.
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` Q. This is the section titled, Claim
`
`Construction.
`
` A. Correct.
`
` Q. And it's -- and encompasses paragraphs 97 to
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`103.
`
` Is that correct?
`
` A. That is correct.
`
` Q. Okay. Paragraph 97, you state, quote: I
`
`understand that the parties dispute the meaning of
`
`the term, quote, a method for treating an
`
`angiogenic eye disorder in a patient, close quote.
`
` Do you see that?
`
` A. I see that.
`
` Q. And in the next paragraph, 98, you state,
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`Mylan Exhibit 1110
`Mylan v. Regeneron, IPR2021-00880
`Page 15
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`quote: I have been informed that the Board has
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`preliminarily found that the phrase, a method for
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`treating an angiogenic eye disorder in a patient,
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`Page 16
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`is limiting.
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` And it goes on from there.
`
` Do you see that?
`
` A. I do.
`
` Q. Paragraph 99, you state: I understand that
`
`Dr. Do has offered the opinion that the claim term
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`method for treating, in Claims 1 and 14 of the
`
`'338 patent, requires highly effective treatment
`
`that was non-inferior to the standard of care by
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`the time the patent was filed in 2011.
`
` Do you see that?
`
` A. I do.
`
` Q. And in paragraph 100, you state: I have
`
`reviewed Dr. Do's declaration and agree with her
`
`conclusion that method of treating requires an
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`effective treatment, and further, that by 2011, the
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`POSA would have understood an effective treatment
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`that was one that was at least non-inferior to the
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`standard of care; i.e., Lucentis.
`
` Do you see that?
`
` A. I do.
`
` Q. Now, Dr. Brown, you did not offer your own
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`Mylan Exhibit 1110
`Mylan v. Regeneron, IPR2021-00880
`Page 16
`
`
`
`Page 17
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`opinion regarding the claim construction for the
`
`'338 patent claim term, a method for treating an
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`angiogenic eye disorder in a patient, correct?
`
` A. Correct.
`
` Q. The next section, the heading 2,
`
`paragraphs 102 and 103, you similarly did not offer
`
`your own opinion regarding the proper claim
`
`construction for the '338 patent claim term,
`
`tertiary dose.
`
` Is that correct?
`
` A. That's correct.
`
` Q. I believe you have, in your first binder,
`
`Exhibit 1001, the '338 patent.
`
` A. I do.
`
` Q. Let's take a look at that.
`
` MS. FISHMAN: Are you done with
`
`Exhibit 2051?
`
` MR. SALMEN: He's going to need that
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`the whole time.
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` MS. FISHMAN: The Do declaration?
`
` MR. SALMEN: Oh, you said 51. I'm
`
`sorry.
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` MS. FISHMAN: Yeah.
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` MR. SALMEN: Done with it for now.
`
` MS. FISHMAN: Okay.
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`Mylan Exhibit 1110
`Mylan v. Regeneron, IPR2021-00880
`Page 17
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`
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` Q. (BY MR. SALMEN) All right. Dr. Brown, you
`
`have the '338 patent in front of you?
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`Page 18
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` A. Yes, sir.
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` Q. Exhibit 1001?
`
` A. I do.
`
` Q. All right. Let's look at Example 4, that
`
`begins column 9.
`
` You reviewed this example in forming the
`
`opinions you set forth in your declaration,
`
`correct?
`
` A. I did.
`
` Q. Okay. And you understand the data that's
`
`presented in Table 1 of Example 4, and that starts
`
`on column 13.
`
` Is that correct?
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` MS. FISHMAN: Objection; vague.
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` MR. SALMEN: That's not a proper
`
`objection, Counsel.
`
` A. I understand Table 1.
`
` Q. (BY MR. SALMEN) Okay. All right.
`
` Dr. Brown, do you -- let's -- I'm going to
`
`focus your attention on what appears in Table 1.
`
`The -- the right-hand column is labeled VEGF-T 2
`
`milligrams every eight weeks, 2Q8.
`
` Do you see this?
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`Veritext Legal Solutions
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`Mylan Exhibit 1110
`Mylan v. Regeneron, IPR2021-00880
`Page 18
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` A. I see that, yeah.
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` Q. And I'm going to refer to this as the 2Q8
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`Page 19
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`arm of this trial.
`
` Is that okay?
`
` A. Perfect.
`
` Q. All right. Now, do you agree that the 2Q8
`
`arm of the clinical trial, summarized by Example 4,
`
`represents a method of treating within the scope of
`
`the '338 patent claims?
`
` MS. FISHMAN: Objection; vague as to
`
`time.
`
` A. Repeat your question. I'm sorry.
`
` Q. (BY MR. SALMEN) Let me ask a follow-up
`
`question.
`
` Your attorney objection -- objected that my
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`question was vague as to time.
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` When I asked the question, did you have a
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`particular time frame in mind to answer it?
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` A. No. I just didn't quite understand your
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`question. Can you repeat it?
`
` Q. Sure. I will repeat it.
`
` For context, why don't we take a quick look
`
`at the claims. We haven't been there yet. Okay?
`
` Claim 1 starts on the last page, in
`
`column 1.
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`Mylan Exhibit 1110
`Mylan v. Regeneron, IPR2021-00880
`Page 19
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` A. On the last page. So column 23?
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` Q. Yes. I'm sorry. I -- I misspoke, and said
`
`column 1. You're correct. It's column 23.
`
` So I'm referring to this claim in my last
`
`question. And I'll restate it. Okay?
`
` A. Okay.
`
` Q. Do you agree that the 2Q8 arm of the
`
`clinical trial, summarized by Example 4, represents
`
`a method of treating within the scope of the '338
`
`patent claims?
`
` MS. FISHMAN: Objection; calls for a
`
`legal conclusion, and vague as to time.
`
` A. So column 4 in that table gives the
`
`percentage of those who lost less than 15 letters,
`
`which was the primary end point on the FDA clinical
`
`trial, VIEW 1, VIEW 2.
`
` It does not encompass the totalitary of
`
`the -- total -- all of the VIEW studies, and what
`
`it means to a clinician.
`
` Q. (BY MR. SALMEN) What does, capture the
`
`total of the VIEW studies --
`
` A. Sure.
`
` Q. -- that would be relevant to a clinician?
`
` MS. FISHMAN: Objection; beyond the
`
`scope.
`
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`Mylan Exhibit 1110
`Mylan v. Regeneron, IPR2021-00880
`Page 20
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`
`
`Page 21
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` You can answer.
`
` A. So when one designs a clinical trial, you
`
`have two objectives. Your first objective is to
`
`try to get a drug approved.
`
` The objective to clinicians, though, is to
`
`determine is something safe, is it effective, and
`
`will it help the patient.
`
` Q. (BY MR. SALMEN) Let me restate my earlier
`
`question, because again, your counsel objected as
`
`to it being vague, with respect to time.
`
` Would your answer to my question change, if
`
`I applied different dates?
`
` A. I'm not sure it would. I'd have to look at
`
`the dates you give me.
`
` Q. Okay. So, here, how about as of
`
`January 2011, the date that you applied in forming
`
`your opinion regarding the '338 patent, does the
`
`2Q8 arm of the clinical trial, summarized by
`
`Example 4, represent a method of treating, within
`
`the scope of the '338 patent claims?
`
` MS. FISHMAN: Objection; calls for
`
`legal conclusion.
`
` But you can answer.
`
` A. Yeah, I'm not -- I'm not a lawyer. And I
`
`would draw you to my declaration, where, again, in
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`Mylan Exhibit 1110
`Mylan v. Regeneron, IPR2021-00880
`Page 21
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`
`
`Page 22
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`paragraph 100 that you read to me, I believe that
`
`an effective method of treatment is one that is at
`
`least non-inferior to the standard of care,
`
`Lucentis.
`
` Q. (BY MR. SALMEN) Okay. Here, I'm going to
`
`show you what's been marked previously as Do
`
`Deposition Exhibit 4.
`
` Have you seen this before?
`
` A. If it's part of the Do declaration, yes.
`
` Q. This is not part of the Do declaration.
`
`This was marked as an exhibit at her deposition
`
`last week.
`
` A. I haven't seen it then. I didn't see her
`
`deposition.
`
` Q. Okay. So go ahead and read the language in
`
`the green highlight.
`
` MR. SALMEN: And for the record,
`
`this is a recreation of Claim 1 for the '338
`
`patent, with Dr. Do's claim constructions inserted
`
`in the green and yellow highlights.
`
` MS. FISHMAN: Are you marking this
`
`as an exhibit --
`
` MR. SALMEN: No.
`
` MS. FISHMAN: -- to his deposition?
`
` MR. SALMEN: No.
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`Mylan Exhibit 1110
`Mylan v. Regeneron, IPR2021-00880
`Page 22
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`
`
`Page 23
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` MS. FISHMAN: But you're showing it
`
`to him?
`
` MR. SALMEN: Yeah.
`
` MS. FISHMAN: Okay. I object. I
`
`would say let's mark this as the next exhibit in
`
`this deposition. I believe it's Exhibit 3.
`
` And for the record, this is a
`
`demonstrative prepared by Petitioner's counsel that
`
`was shown to Dr. Do in her deposition and is now
`
`being shown to Dr. Brown.
`
` Q. (BY MR. SALMEN) Did you review the green
`
`language in there?
`
` A. Still reviewing it.
`
` Q. Okay.
`
` A. I read the green.
`
` Q. Okay. With that language in mind, can you
`
`answer my question, as of January 13th, 2011, the
`
`date that you applied in forming your opinions,
`
`does the 2Q8 arm of the clinical trial, summarized
`
`by Example 4, represent a method of treating,
`
`within the scope of the '338 patent claims?
`
` MS. FISHMAN: Objection; beyond the
`
`scope, and calls for a legal conclusion.
`
` A. I say it doesn't. It -- you know, when I
`
`just see loss of 95 percent -- we have a lot of
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`888-391-3376
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`Mylan Exhibit 1110
`Mylan v. Regeneron, IPR2021-00880
`Page 23
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`
`
`Page 24
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`trials that did that, Macugen included, that
`
`weren't effective treatments, and weren't inferior
`
`to the standard of care, in my opinion.
`
` Q. (BY MR. SALMEN) Okay. We'll go ahead and
`
`mark that now.
`
` MS. FISHMAN: I already did.
`
` MR. SALMEN: Shoot. Here it is.
`
`Can I have that copy back?
`
` I'm going to mark this Brown
`
`Exhibit 3. And that Brown Exhibit 3 is a printout
`
`of Do Deposition Exhibit 4.
`
` (Exhibit 3 is marked.)
`
` Q. (BY MR. SALMEN) And let me ask you another
`
`question similar to the last one, but I'm going to
`
`give you another date, because I don't want --
`
` A. Okay.
`
` Q. -- to raise another vague as to time
`
`objection. Okay? Okay?
`
` A. Okay.
`
` Q. So, as of December 2012, after the Heier
`
`2012 publication came out, does the 2Q8 arm of the
`
`clinical trial, summarized by Example 4, represent
`
`a method of treating, within the scope of the '338
`
`patent claims?
`
` MS. FISHMAN: Objection; beyond the
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`888-391-3376
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`Veritext Legal Solutions
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`Mylan Exhibit 1110
`Mylan v. Regeneron, IPR2021-00880
`Page 24
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`
`
`Page 25
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`scope of this witness's declaration, and calls for
`
`a legal conclusion.
`
` You can answer.
`
` A. I don't think the percentage of less than 15
`
`letter gainers allows me to determine whether it's
`
`a method of treatment, according to my
`
`declaration --
`
` Q. (BY MR. SALMEN) Okay.
`
` A. -- definition.
`
` Q. Let's turn back to your declaration. And
`
`I'm going to direct your attention to the section
`
`beginning at paragraph 75.
`
` This section, you title, VIEW 1 and VIEW 2.
`
` Is that correct?
`
` A. That's correct.
`
` Q. And this section spans from paragraph 75,
`
`through -- it looks like paragraph 85.
`
` A. Correct.
`
` Q. And that's between pages 35 and 43.
`
` Is that correct?
`
` A. Correct.
`
` Q. Now, in paragraph 75 to 82, you provide a
`
`summary of the VIEW clinical trials, based on the
`
`Heier 2012 publication.
`
` Is that correct?
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`www.veritext.com
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`888-391-3376
`
`Veritext Legal Solutions
`
`Mylan Exhibit 1110
`Mylan v. Regeneron, IPR2021-00880
`Page 25
`
`
`
`Page 26
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` A. That's correct.
`
` MS. FISHMAN: Objection; document
`
`speaks for itself.
`
` MR. SALMEN: It's his direct
`
`examination testimony, Counsel. It's a completely
`
`improper objection. This is cross-examination. I
`
`can ask him the questions.
`
` MS. FISHMAN: You can ask your
`
`question, and I can lodge my objections, which I
`
`just did. The document speaks for itself.
`
` MR. SALMEN: The document does not
`
`speak for itself. It's his direct examination
`
`testimony.
`
` MS. FISHMAN: Correct. But you're
`
`asking him a question that lacks foundation, based
`
`on the fact that he's quoting more than just the
`
`Heier 2012 publication in his declaration.
`
` Q. (BY MR. SALMEN) Okay. Let's go through the
`
`paragraphs. Okay.
`
` Paragraph 75, do you cite anything other
`
`than Exhibit 1018, Heier '12, in paragraph 75?
`
` A. In paragraph 75, I do not.
`
` Q. Okay. Paragraph 76, do you cite to anything
`
`other than Exhibit 1018, Heier 2012?
`
` A. I do not.
`
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`www.veritext.com
`
`888-391-3376
`
`Veritext Legal Solutions
`
`Mylan Exhibit 1110
`Mylan v. Regeneron, IPR2021-00880
`Page 26
`
`
`
`Page 27
`
` Q. Okay. In paragraph 76, you do cite another
`
`document, other than Heier 2012.
`
` Is that correct?
`
` A. That's incorrect. It's paragraph 77.
`
` Q. Oops. Well, thank you for that correction.
`
` In paragraph 77, you cite to Exhibit 2097,
`
`and then you provide a footnote for what that
`
`document is, correct?
`
` A. I take your word for it on the number of the
`
`exhibit. So, yeah.
`
` Q. So, it -- it -- you have it in -- in your
`
`declaration, under about the third line --
`
` A. 2097. There you go.
`
` Q. Gotcha.
`
` A. Yeah, perfect.
`
` Q. And that is,
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