throbber
IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`Petitioner,
`
`vs.
`
`SAMSUNG BIOEPIS CO., LTD., )
`)
`) Patent No.
`) 10,888,601
`)
`) Inter Partes
`REGENERON PHARMACEUTICALS, ) Review No.
`INC.,
`
` IPR2023-00739
`
`) )
`
`)
`Patent Owner.
`___________________________ )
`
`VIDEOTAPE DEPOSITION OF:
`
`EDWARD CHAUM, M.D., Ph.D.
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`Taken on behalf of the Patent Owner
`
`January 5, 2024
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`Veritext Legal Solutions
`Calendar-CA@veritext.com 866-299-5127
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`Samsung et al. v. Regeneron IPR2023-00884
`Regeneron Pharmaceuticals, Inc. Exhibit 2062 Page 1
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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 :
` Z a c h S u m m e r s , E s q .
` Q U I N N E M A N U E L U R Q U H A R T & S U L L I V A N , L L P
` 5 1 M a d i s o n A v e n u e
` 2 2 n d F l o o r
` N e w Y o r k , N e w Y o r k 1 0 0 1 0
` 2 1 2 . 8 4 9 . 7 0 0 0
` Z a c h s u m m e r s @ q u i n n e m a n u e l . c o m
` F o r t h e P a t e n t O w n e r :
` A d a m R . B r a u s a , E s q .
` J a c k L a n e , E s q .
` M O R R I S O N & F O E R S T E R L L P
` 4 2 5 M a r k e t S t r e e t
` S a n F r a n c i s c o , C a l i f o r n i a 9 4 1 0 5
` 4 1 5 . 2 6 8 . 6 0 5 3
` A B r a u s a @ m o f o . c o m
` A l s o P r e s e n t :
` E i l e e n W o o - R e g e n e r o n ( v i a Z o o m )
` S t e p h a n i e F r e e m a n - V i d e o g r a p h e r
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`Page 2
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`Samsung et al. v. Regeneron IPR2023-00884
`Regeneron Pharmaceuticals, Inc. Exhibit 2062 Page 2
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`

`

` I N D E X
` Page/Line
` THE WITNESS: EDWARD CHAUM, M.D., Ph.D.
` EXAMINATION BY MR. BRAUSA 5 24
`
` INDEX OF EXHIBITS
` Exhibits Description Page/Line
` Exhibit 1016 Indication and Use 128 21
` Documents for EYLEA
`
` Exhibit 1001 U.S. Patent 10,888,601 151 17
` B2
` Exhibit 1002 Declaration of Dr. 138 13
` Edward Chaum
`
` Exhibit 1006 Article: Randomized 233 21
` Trial Evaluating
` Ranibizumab Plus Prompt
` of Deferred Laser or
` Triamcinolone Plus
` Prompt Laser for
` Diabetic Macular Edema
`
` Exhibit 1009 September 14, 2009 263 2
` Regeneron Press Release
` Exhibit 1010 International 285 1
` Application WO
` 2006/047325 A1
` Exhibit 1044 U.S. Patent 298 13
` 2007/0190058 A1
` Exhibit 1056 U.S. Patent 9,254,338 227 23
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`Samsung et al. v. Regeneron IPR2023-00884
`Regeneron Pharmaceuticals, Inc. Exhibit 2062 Page 3
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`

` The videotape deposition of
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` EDWARD CHAUM, M.D., Ph.D, was taken by
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` counsel for the Patent Owner, on January
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` 5, 2024, commencing at 9:03 a.m., in the
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` offices of Dickinson Wright, 424 Church
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` Street, Suite 1401, Nashville,
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` Tennessee, for all purposes under the
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` Federal Rules of Civil Procedure.
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` The formalities as to notice,
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` caption, certificate, et cetera, are not
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` waived. All objections, except as to
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` the form of the questions, are reserved
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` to the hearing.
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` It is agreed that Carissa L.
`
` Boone, being a Notary Public and Court
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` Reporter, may swear the witness, and
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` that the reading and signing of the
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` completed deposition by the witness are
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` not waived.
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` * * *
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`Page 4
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`Samsung et al. v. Regeneron IPR2023-00884
`Regeneron Pharmaceuticals, Inc. Exhibit 2062 Page 4
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` THE VIDEOGRAPHER: Good morning. 09:03:31AM
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` We are going on the record at 9:03 a.m. 09:03:32AM
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` The attorneys have -- the date is 09:03:39AM
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` January 5th, 2024. 09:03:41AM
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` The attorneys have waived the 09:03:43AM
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` standard video introduction to the video 09:03:44AM
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` deposition of Dr. Edward Chaum. 09:03:46AM
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` Counsel, please state your 09:03:49AM
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` appearance for the record which will 09:03:51AM
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` then be followed by the swearing in of 09:03:52AM
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` the witness by the court reporter. 09:03:54AM
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` MR. SUMMERS: Zach Summers for 09:03:57AM
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` Petitioner Samsung Bioepis and the 09:03:59AM
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` witness. 09:04:03AM
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` MR. BRAUSA: Adam Brausa for 09:04:04AM
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` patent owner Regeneron. I'm joined by 09:04:06AM
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` my colleague Jack Lane. We're both from 09:04:09AM
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` the Morrison & Foerster firm. And on 09:04:10AM
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` the Zoom is Eileen Woo from Regeneron. 09:04:12AM
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` EDWARD CHAUM, M.D., Ph.D., 09:04:12AM
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` having been first duly sworn, was examined and 09:04:12AM
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` testified as follows: 09:04:22AM
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` THE WITNESS: I do. 09:04:22AM
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` EXAMINATION 09:04:24AM
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` BY MR. BRAUSA: 09:04:24AM
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`Veritext Legal Solutions
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`Page 5
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`Samsung et al. v. Regeneron IPR2023-00884
`Regeneron Pharmaceuticals, Inc. Exhibit 2062 Page 5
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` Q. Good morning, Dr. Chaum. Thank 09:04:24AM
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` you for being here. 09:04:28AM
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` A. Good morning. 09:04:29AM
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` Q. I'll do my best to pronounce your 09:04:30AM
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` name correctly. If I misstep, please do correct 09:04:32AM
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` me. 09:04:35AM
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` A. That's correct. It's Chaum. 09:04:36AM
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` Q. Got it. 09:04:37AM
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` And I know you've been deposed 09:04:37AM
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` before relating to proceedings between Samsung and 09:04:39AM
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` Regeneron, but if I ask any questions that you 09:04:44AM
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` don't understand or they're unclear, please feel 09:04:46AM
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` free to ask me at to clarify. 09:04:49AM
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` A. Okay. 09:04:50AM
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` Q. We're here in IPR 2023-739 about 09:04:51AM
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` U.S. Patent 10,888,601. Is that your 09:05:00AM
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` understanding? 09:05:04AM
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` A. Yes. 09:05:06AM
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` Q. And if I refer to that as the 09:05:08AM
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` '601 patent, will that be clear to you? 09:05:11AM
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` A. Yes. 09:05:12AM
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` Q. Okay. And I may refer to other 09:05:12AM
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` patents from time to time during today's 09:05:14AM
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` questioning. I'll do my best to make it clear 09:05:17AM
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` which patent I'm referring to, but you'll see we 09:05:19AM
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`Page 6
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`Samsung et al. v. Regeneron IPR2023-00884
`Regeneron Pharmaceuticals, Inc. Exhibit 2062 Page 6
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` patent attorneys always shorten it to three 09:05:22AM
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` digits. If it's ever unclear, please ask me to 09:05:25AM
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` clarify, okay? 09:05:28AM
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` A. Okay. 09:05:29AM
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` Q. When were you retained for this 09:05:29AM
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` particular proceeding? 09:05:31AM
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` A. Probably about -- I was -- about 09:05:32AM
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` a year and a half ago, I believe, by Quinn 09:05:36AM
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` Emanuel. 09:05:39AM
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` Q. Okay. Do you recall who reached 09:05:39AM
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` out to you from Quinn Emanuel? 09:05:41AM
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` A. I don't offhand, no. 09:05:43AM
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` Q. Prior to this representation, had 09:05:44AM
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` you worked with Quinn Emanuel before? 09:05:47AM
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` A. No. 09:05:49AM
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` Q. Prior to your work with Quinn 09:05:49AM
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` Emanuel, had you served as an expert in any patent 09:05:52AM
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` cases? 09:05:55AM
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` A. I initially did some work for 09:05:56AM
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` another patent firm that was retained by Samsung 09:06:01AM
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` Bioepis, Desmarais. 09:06:07AM
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` Q. Okay. 09:06:08AM
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` A. And I did some initial work for 09:06:08AM
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` them. But then that was discontinued, and I was 09:06:11AM
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` retained by Quinn Emanuel. 09:06:13AM
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`Samsung et al. v. Regeneron IPR2023-00884
`Regeneron Pharmaceuticals, Inc. Exhibit 2062 Page 7
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` Q. Okay. And in your work for the 09:06:14AM
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` Desmarais firm, was that relating to biosimilars 09:06:17AM
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` work as well -- 09:06:21AM
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` A. It was. 09:06:21AM
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` Q. -- for Samsung? 09:06:23AM
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` A. It was. 09:06:23AM
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` Q. What biosimilar was your 09:06:23AM
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` representation relating to -- 09:06:25AM
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` A. I -- 09:06:25AM
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` Q. -- if you can disclose it. 09:06:26AM
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` A. I -- I don't recall offhand. It 09:06:27AM
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` was an initial interest in my expertise related to 09:06:28AM
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` -- to biosimilars in general. 09:06:33AM
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` Q. Okay. And -- and what expertise 09:06:34AM
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` do you have with respect to biosimilars in 09:06:37AM
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` general? 09:06:39AM
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` A. I'm a practitioner of 09:06:39AM
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` ophthalmology. I'm a retina specialist. 09:06:43AM
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` Q. Okay. We talked about your 09:06:45AM
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` retention by Quinn Emanuel in this proceeding. I 09:06:49AM
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` had mentioned that you had been deposed 09:06:52AM
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` previously. And, in fact, you're retained by 09:06:55AM
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` Quinn Emanuel on behalf of Samsung in a proceeding 09:06:58AM
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` designated IPR 2023-442 relating to U.S. Patent 09:07:02AM
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` 10,130,681 or the '681 patent. 09:07:07AM
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`Samsung et al. v. Regeneron IPR2023-00884
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` Are you familiar with that? 09:07:12AM
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` A. Yes. 09:07:13AM
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` Q. And, in fact, this is a 09:07:13AM
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` proceeding in which you were deposed roughly a 09:07:16AM
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` month or so ago? 09:07:18AM
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` A. October of last year, I believe. 09:07:20AM
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` Q. Okay. So a little more than a 09:07:22AM
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` month. My math was off. 09:07:25AM
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` After the deposition occurred in 09:07:26AM
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` that case, did you go back and read your trans- -- 09:07:29AM
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` read the transcript of your deposition? 09:07:32AM
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` A. I have not. 09:07:32AM
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` Q. Okay. And sitting here today, is 09:07:33AM
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` there anything that happened during that 09:07:35AM
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` deposition or testimony that you'd like to 09:07:38AM
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` correct? 09:07:40AM
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` A. I haven't had a chance to review 09:07:41AM
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` it, so I haven't had a chance to correct anything 09:07:43AM
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` that I might see. 09:07:46AM
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` Q. Okay. But sitting here today, 09:07:47AM
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` there's nothing that is in your mind as something 09:07:50AM
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` that you need to correct once you review the 09:07:52AM
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` deposition transcript? 09:07:54AM
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` A. Not offhand, but I'd have to see 09:07:55AM
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` the deposition transcript. 09:07:57AM
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` Q. Okay. And, again, just sitting 09:07:58AM
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` here today without reviewing line-by-line the 09:08:00AM
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` deposition transcript, is there any reason for you 09:08:03AM
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` to think that the testimony that you provided in 09:08:05AM
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` that proceeding regarding the '681 patent was not 09:08:08AM
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` truthful and accurate? 09:08:10AM
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` A. No, no reason at all. 09:08:11AM
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` Q. Okay. Now, you were also 09:08:12AM
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` retained by Quinn Emanuel on behalf of Petitioner 09:08:15AM
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` Samsung in IPR 2023-884 regarding U.S. Patent 09:08:17AM
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` 11,253,572 or the '572 patent, correct? 09:08:23AM
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` A. Yes. 09:08:27AM
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` Q. And we were actually just 09:08:27AM
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` discussing, you've not been deposed in that 09:08:30AM
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` matter. We're anticipating a deposition in that 09:08:35AM
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` matter in the next month or so, right? 09:08:36AM
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` A. As I understand it, yes. 09:08:39AM
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` Q. Okay. And so if I have done my 09:08:41AM
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` math right this time, those are three separate 09:08:42AM
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` proceedings in which you've been retained by Quinn 09:08:45AM
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` Emanuel on behalf of Petitioner Samsung, correct? 09:08:48AM
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` A. Yes. 09:08:51AM
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` Q. Are there any other IPR 09:08:51AM
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` proceedings in which you've been retained as an 09:08:54AM
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` expert by Quinn Emanuel? 09:08:56AM
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` A. Not that I'm aware of at this 09:08:58AM
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` time. 09:08:59AM
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` Q. Okay. And when you were retained 09:08:59AM
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` by Quinn Emanuel -- about a year and a half ago, I 09:09:02AM
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` think you said? 09:09:04AM
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` A. Something like that. Year and a 09:09:06AM
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` half to two years. 09:09:07AM
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` Q. Was it with respect to a 09:09:08AM
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` particular patent, or was it just with respect to 09:09:10AM
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` subject matter in general? 09:09:14AM
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` A. Subject matter in general. 09:09:15AM
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` Q. Okay. And if you recall, when 09:09:16AM
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` did you -- or when were you informed that there 09:09:19AM
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` would be a need for three different declarations 09:09:22AM
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` in three different proceedings? 09:09:25AM
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` A. I was not informed in advance of 09:09:28AM
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` that. I've become aware of it as these 09:09:30AM
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` proceedings have continued. 09:09:33AM
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` Q. Okay. And I'm going to ask you 09:09:35AM
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` some questions about your -- your preparation 09:09:36AM
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` process and the work that you did preparing your 09:09:39AM
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` declarations. I want to make it clear, I don't 09:09:42AM
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` want to hear about conversations that you had with 09:09:44AM
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` your attorneys, unless I'm specifically asking 09:09:46AM
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` about it. 09:09:48AM
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` So if there's a question or -- or 09:09:49AM
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` you have any concern that it will reveal the 09:09:52AM
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` substance of those communications, just ask me to 09:09:54AM
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` rephrase and I can do that, okay? 09:09:59AM
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` A. Okay. 09:10:00AM
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` Q. So when you were in the process 09:10:00AM
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` -- it -- let me establish -- actually, in each of 09:10:03AM
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` these proceedings, you understand there's a 09:10:05AM
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` petition filed by Samsung and then that petition 09:10:07AM
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` for Inter Partes Review is supported by an expert 09:10:13AM
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` declaration from yourself? 09:10:17AM
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` A. Yes. 09:10:19AM
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` Q. And so in each of these 09:10:19AM
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` proceedings, you're the author of three separate 09:10:21AM
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` expert opinions, correct? 09:10:24AM
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` A. Yes. 09:10:25AM
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` Q. And in each of these proceedings, 09:10:26AM
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` you've offered opinions on whether the claims that 09:10:29AM
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` are challenged by Samsung in those proceedings are 09:10:32AM
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` valid, correct? 09:10:36AM
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` A. In part, yes. 09:10:37AM
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` Q. Okay. In each of these 09:10:40AM
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` proceedings, it's your opinion that all of the 09:10:42AM
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` claims challenged by Samsung are invalid, correct? 09:10:47AM
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` A. I'm -- I'm sorry, just if you 09:10:49AM
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`Samsung et al. v. Regeneron IPR2023-00884
`Regeneron Pharmaceuticals, Inc. Exhibit 2062 Page 12
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` could restate the question so I understand it 09:10:51AM
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` fully. 09:10:54AM
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` Q. Sure. 09:10:54AM
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` In each of the three IPR 09:10:55AM
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` proceedings in which you have provided expert 09:10:57AM
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` opinions on behalf of Samsung, your overarching 09:10:59AM
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` opinion is that the claims in each patent 09:11:03AM
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` challenged by Samsung are invalid, correct? 09:11:05AM
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` A. Yes. 09:11:08AM
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` Q. Have you ever provided any expert 09:11:09AM
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` opinions, on behalf of anyone, that claims of a 09:11:11AM
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` patent are valid? 09:11:15AM
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` A. No. 09:11:18AM
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` Q. In terms of your work process 09:11:18AM
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` preparing the three declarations for Samsung in 09:11:24AM
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` which you've been retained by Quinn Emanuel, did 09:11:27AM
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` the work on those declarations occur independently 09:11:30AM
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` or did it occur in parallel? 09:11:33AM
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` MR. SUMMERS: Objection, vague. 09:11:36AM
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` THE WITNESS: As I think back to 09:11:41AM
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` my preparation, for the most part, the 09:11:43AM
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` work was done independently, but there 09:11:46AM
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` is overlap in terms of the literature 09:11:49AM
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` and some of the issues with respect to 09:11:52AM
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` the patents. So there was some parallel 09:11:55AM
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`Page 13
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`Samsung et al. v. Regeneron IPR2023-00884
`Regeneron Pharmaceuticals, Inc. Exhibit 2062 Page 13
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` work that was done in that regard. 09:11:59AM
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` BY MR. BRAUSA: 09:12:02AM
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` Q. Okay. I think it's -- it's in 09:12:02AM
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` your report and you mentioned it. You've been an 09:12:08AM
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` ophthalmologist for, what, 30 years now? 09:12:12AM
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` A. Yes. 09:12:14AM
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` Q. Okay. And you started out in 09:12:14AM
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` pediatrics and then moved into ophthalmology, if I 09:12:16AM
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` have that correct? 09:12:20AM
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` A. Yes. 09:12:20AM
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` Q. When you were working in 09:12:20AM
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` pediatrics, was that pediatric ophthalmology, or 09:12:22AM
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` was that pediatrics more generally? 09:12:25AM
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` A. No, that was a pediatric 09:12:26AM
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` residency. 09:12:29AM
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` Q. Okay. And what led to your 09:12:30AM
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` interest in ophthalmology to move from the 09:12:31AM
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` pediatric residency? 09:12:36AM
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` A. So my -- I'm both a 09:12:37AM
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` physician/medical doctor and a Ph.D. My doctoral 09:12:40AM
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` thesis was in the genetics of a pediatric eye 09:12:45AM
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` disease called retinoblastoma, which is a tumor of 09:12:48AM
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` the developing retina. And in the course of my 09:12:51AM
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` doctoral work, I became interested in two 09:12:53AM
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` different areas of clinical medicine as I was 09:12:56AM
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`Page 14
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`Samsung et al. v. Regeneron IPR2023-00884
`Regeneron Pharmaceuticals, Inc. Exhibit 2062 Page 14
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` conceiving of my practice going forward. 09:12:59AM
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` One was in the area of pediatric 09:13:01AM
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` gene transfer/gene therapy, which in the 1980s was 09:13:07AM
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` an exciting and new area of clinical medicine. 09:13:10AM
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` And at that time, the concept of gene therapy in 09:13:13AM
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` pediatrics was predicated around bone marrow 09:13:16AM
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` transplantation. We were going to take and fix 09:13:19AM
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` the gene of patients with sickle cell anemia, 09:13:22AM
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` cystic fibrosis, other conditions. 09:13:26AM
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` And so my plan at that time was 09:13:28AM
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` to become a pediatric oncologist, do marrow -- 09:13:30AM
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` bone marrow transplantation, and apply my interest 09:13:35AM
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` in gene transfer, which I had done in my doctoral 09:13:37AM
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` work, to the application of gene therapy in 09:13:41AM
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` clinical medicine. 09:13:44AM
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` So I started in pediatrics. But 09:13:44AM
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` after two years in pediatrics and working in 09:13:47AM
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` pediatric oncology and bone marrow 09:13:50AM
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` transplantation, I heard -- I realized that that 09:13:52AM
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` was not the career path that I wanted to take. 09:13:55AM
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` And so I -- again because of my interest in 09:13:58AM
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` ophthalmology and retinal diseases and the work 09:14:01AM
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` that I had done as part of my doctoral work, I 09:14:04AM
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` applied and was accepted into an ophthalmology 09:14:07AM
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` program and then went on to become a retina 09:14:11AM
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`Samsung et al. v. Regeneron IPR2023-00884
`Regeneron Pharmaceuticals, Inc. Exhibit 2062 Page 15
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` specialist. 09:14:14AM
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` Q. I see. 09:14:14AM
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` And in looking back, why was it 09:14:15AM
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` that that was not a career path that you decided 09:14:16AM
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` to take? 09:14:18AM
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` A. I -- I think a couple reasons. 09:14:18AM
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` One is as a clinician, as a physician working with 09:14:21AM
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` the families of children who were dying is a very, 09:14:24AM
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` very difficult process. 09:14:28AM
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` Q. Sure. 09:14:29AM
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` A. And experiencing that firsthand, 09:14:30AM
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` there are, you know, wonderful physicians who go 09:14:32AM
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` into that for a career. From my perspective, it 09:14:36AM
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` was, I think, just too difficult of a career path 09:14:40AM
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` for me in terms of my initial experience with it. 09:14:43AM
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` And so that's the -- that -- that's the main 09:14:47AM
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` reason. 09:14:51AM
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` Q. Okay. And when you made the 09:14:52AM
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` switch or when you moved more to a focus on 09:14:54AM
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` ophthalmology, at -- at all points in your career, 09:14:57AM
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` you've been a prescribing physician, so to speak; 09:15:00AM
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` meaning you've been treating and -- and 09:15:03AM
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` administering drugs to patients, correct? 09:15:05AM
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` A. Yes. 09:15:07AM
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` Q. And in this case, we are -- we're 09:15:07AM
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`Page 16
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`Samsung et al. v. Regeneron IPR2023-00884
`Regeneron Pharmaceuticals, Inc. Exhibit 2062 Page 16
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` dealing with a specific type of drug that -- that 09:15:10AM
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` I see referred to in your declaration and 09:15:13AM
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` elsewhere, it's an anti-VEGF antagonist? 09:15:17AM
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` A. An anti-VEGF agent, yeah. So 09:15:18AM
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` VEGF antagonist. 09:15:21AM
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` Q. Okay. Agent or antagonist, do 09:15:22AM
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` you call -- have a preference? 09:15:23AM
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` A. It -- it doesn't matter to me. 09:15:25AM
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` Q. Okay, got it. 09:15:27AM
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` And my understanding is VEGF is a 09:15:28AM
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` protein that the body naturally produces, correct? 09:15:30AM
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` A. Yes. 09:15:33AM
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` Q. And in certain individuals, it's 09:15:33AM
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` overexpressed? 09:15:37AM
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` A. In certain disease states -- 09:15:39AM
`
` Q. Okay. 09:15:40AM
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` A. -- it can be overexpressed, yes. 09:15:41AM
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` Q. Okay. And what's the impact of 09:15:43AM
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` that overexpression, for instance, in diabetic 09:15:45AM
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` macular in-depth [sic] -- or edema? Excuse me. 09:15:48AM
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` A. So the impact of VEGF expression 09:15:52AM
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` in diabetes is actually quite diverse. So as the 09:15:54AM
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` retina becomes damaged from high blood sugars in 09:15:59AM
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` patients with diabetes, a couple of things happen. 09:16:04AM
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` One is that the retinal vessels 09:16:07AM
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`Page 17
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`Samsung et al. v. Regeneron IPR2023-00884
`Regeneron Pharmaceuticals, Inc. Exhibit 2062 Page 17
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` start to become incompetent. The connections 09:16:11AM
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` between the -- the tight junctions between the 09:16:15AM
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` cells that control the egress of fluid from the 09:16:17AM
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` vessels into the retina become incompetent, they 09:16:20AM
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` become dilated, and the fluid can begin to leak 09:16:24AM
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` into the retina. The retina is like the film of 09:16:28AM
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` the camera. It's the part of the eye that we see 09:16:31AM
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` with. As that leakage occurs, the retina can 09:16:33AM
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` become swollen and that becomes a manifestation of 09:16:36AM
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` diabetic eye disease. In this case, as we're 09:16:41AM
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` discussing it, what's caused macular edema and can 09:16:43AM
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` cause vision loss in patients. 09:16:46AM
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` VEGF also plays a role in 09:16:46AM
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` diabetes in that as the vessels continue to become 09:16:49AM
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` damaged, over time, the small retinal vessels will 09:16:52AM
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` start to close off. The retina starts to lose its 09:16:55AM
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` blood supply. And as it loses its blood supply, 09:16:58AM
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` the biological response of the retina is to try 09:17:01AM
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` and grow new blood vessels. 09:17:05AM
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` That's what happens in a normal 09:17:07AM
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` healing process. If you cut your hand, the body 09:17:08AM
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` recognizes that injury, it stimulates the 09:17:11AM
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` proliferation of fibrous tissue and the growth of 09:17:14AM
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` new vessels to heal that wound. 09:17:17AM
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` The same thing is basically 09:17:19AM
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`Page 18
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`Samsung et al. v. Regeneron IPR2023-00884
`Regeneron Pharmaceuticals, Inc. Exhibit 2062 Page 18
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` happening in the eye. The retina is losing its 09:17:20AM
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` blood supply, it's trying to grow new blood 09:17:24AM
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` vessels, and -- and in -- to do it, what it does

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