UNITED STATES PATENT AND TRADEMARK OFFICE
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
` __________________________________
` SAMSUNG BIOEPIS CO, LTD.,
` Petitioner,
` vs.
` REGENERON PHARMACEUTICALS, INC.,
` Patent Owner.
` __________________________________
`
` Case IPR2023-008844
`
` U.S. Patent No. 11,253,572
`
`VIDEO-RECORDED
`DEPOSITION OF: MICHAEL STEWART, MD
`
`DATE: May 30, 2024
`
`TIME: COMMENCED: 8:49 a.m.
` CONCLUDED: 2:03 p.m.
`TAKEN BY: Petitioner
`PLACE: Hampton Inn Jacksonville/Ponte Vedra
` Beach
` 1220 Marsh Landing Parkway
` Jacksonville Beach, Florida 32250
`
`REPORTED BY: Mae Fisher, RMR, CRR
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`Veritext Legal Solutions
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`Page 1
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`Samsung Bioepis Exhibit 1076
`Page 1
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`

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`1 Exhibit 9 - Article entitled Ranibizumab versus
` Verteprofin Photodynamic Therapy
`2 For Neovascular Age-Related
` Macular Degeneration: Two-Year
`3 Results of the ANCHOR Study .......... 153
`4 Exhibit 10 - Article entitled Randomized,
` Double-Masked, Sham-Controlled Trial
`5 of Ranibizumab for Neovascular
` Age-related Macular Degeneration:
`6 PIER Study Year 1 ................... 163
`
`78
`
` S T I P U L A T I O N S
`9 It is hereby stipulated and agreed by and
`between counsel present for the respective parties, and
`10 the deponent, that the reading and signing of the
`deposition are hereby RESERVED.
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`1 A P P E A R A N C E S:
`2 RAYMOND NIMROD, ESQUIRE
`Of: Quinn, Emanuel, Urquart & Sullivan, LLP
`3 51 Madison Avenue
` 22nd Floor
`4 New York, New York 10010
` (212) 849-7000
`5 Raynimrod@quinnemanuel.com
`6 Counsel for the PETITIONER
`7 ADAM BRAUSA, ESQUIRE
`REBECCA WEIRES, ESQUIRE
`8 Of: Morrison & Foerster, LLP
` 425 Market Street
`9 San Francisco, CA 94105
` (415) 268-6053
`10 Abrausa@mofo.com
` Rweires@mofo.com
`
`11
`
` Counsel for the PATENT OWNER
`
`12
`13 ALSO PRESENT:
`14 JOSEPH MACKIN
`Videographer
`
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`
`1 I N D E X
`2 TESTIMONY OF MICHAEL STEWART, MD
`3 DIRECT EXAMINATION BY MR. NIMROD ......... 6
`4 CERTIFICATE OF OATH ............................ 187
`5 REPORTER'S DEPOSITION CERTIFICATE .............. 188
`6 NOTIFICATION LETTER ............................ 189
`7 ERRATA SHEET ................................... 190
`8
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` E X H I B I T S
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`10
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`11
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`Exhibit 1 - 572 Patent ......................... 6
`
`Exhibit 2 - Declaration of Michael Stewart, MD . 6
`
`Exhibit 3 - Article entitled The 1-year
`12 Results of CLEAR-IT 2, Phase 2
` Study of Vascular Endothelial
`13 Growth Factor Trap-Eye Dosed
` As-needed After 12-week Fixed
`14 Dosing ............................. 36
`15 Exhibit 4 - Article entitled VEGF-Trap-Eye for
` the Treatment of Neovascular
`16 Age-Related Macular Degeneration ... 63
`17 Exhibit 5 - Article entitled VEGF-Trap-Eye in
` Wet AMD CLEAR-IT 2: Summary of
`18 One-Year Key Results ............... 68
`19 Exhibit 6 - Patent Owner's Preliminary Response. 68
`20 Exhibit 7 - Article entitled Ranibizumab for
` Neovascular Age-Related Macular
`21 Degeneration ....................... 140
`22 Exhibit 8 - Article entitled Predicted
` Biological Activity of Intravitreal
`23 VEGF-Trap .......................... 144
`24
`25
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`Page 2
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`Page 4
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`1 P R O C E E D I N G S
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`2 THE VIDEOGRAPHER: Good morning. My name is 08:49:25
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`3 Joseph Mackin, the videographer, and we are now on 08:49:40
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`4 live video record. 08:49:44
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`5 Please be aware that microphones are sensitive
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`6 and can pick up whispering, private conversations and 08:49:45
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`7 cellular interference. Please silence all cell phones 08:49:49
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`8 or place them away from the microphones, as they can 08:49:51
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`9 interfere with the deposition's audio. Audio and 08:49:54
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`10 video recording will continue to take place unless all 08:49:56
`
`11 parties agree to go off the record. 08:50:00
`
`12 We are here recording live at 1220 Marsh 08:50:02
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`13 Landing Parkway in Jacksonville Beach, Florida 32250, 08:50:05
`
`14 for the video deposition of Michael W. Stewart. The 08:50:08
`
`15 time is 8:50. The date is Thursday, May 30, 2024. 08:50:12
`
`16 Would all counsel please state their appearance 08:50:18
`
`17 for the record and the witness will be sworn in. 08:50:21
`
`18 MR. NIMROD: Ray Nimrod from Quinn Emanuel for 08:50:22
`
`19 petitioner. 08:50:25
`
`20 MR. BRAUSA: Adam Brausa from Morrison & 08:50:25
`
`21 Foerster on behalf of patent owner and joined by my 08:50:30
`
`22 colleague, Rebecca Weires. And I believe on the 08:50:33
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`23 remote realtime is Eileen Woo from Regeneron. 08:50:38
`
`24 THE COURT REPORTER: Can you raise your right 08:50:47
`
`25 hand, please.
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`Page 3
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`Page 5
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`2 (Pages 2 - 5)
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`Page 2
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`

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`1 Do you solemnly swear or affirm that the
`2 testimony you are about to give in this cause will be
`3 the truth, the whole truth, and nothing but the truth?
`4 THE WITNESS: I do. 08:50:48
`5 MICHAEL STEWART, MD, 08:50:48
`6 a witness herein, having been first duly sworn, was
`7 examined, and testified as follows: 08:50:49
`8 DIRECT EXAMINATION 08:50:49
`9 BY MR. NIMROD: 08:50:49
`10 Q. Good morning, Dr. Stewart. 08:50:50
`11 A. Good morning, Mr. Nimrod. 08:50:51
`12 MR. NIMROD: I'd like to mark as Stewart 08:50:55
`13 Exhibit 1 a copy of the 572 patent. 08:50:56
`14 (Exhibit No. 1 was marked for identification.) 08:51:08
`15 MR. NIMROD: I'd also like to mark as Stewart 08:51:22
`16 Exhibit 2 a copy of Dr. Stewart's declaration. 08:51:23
`17 (Exhibit No. 2 was marked for identification.) 08:51:34
`18 BY MR. NIMROD: 08:51:34
`19 Q. Here you go. 08:51:36
`20 A. Thank you. 08:51:37
`21 MR. BRAUSA: Thank you. 08:51:37
`22 BY MR. NIMROD:
`23 Q. Dr. Stewart, if you could turn in your 08:51:42
`24 declaration to paragraph 65, please -- 64. 08:51:44
`25 A. Okay. 08:51:56
`
`Page 6
`
`1 in the dependent claim only two secondary doses are 08:53:24
`2 administered to the patient. 08:53:28
`3 Do you see that? 08:53:29
`4 A. Yes, I do. 08:53:29
`5 Q. So what is the predetermined fixed dosing regimen 08:53:31
`6 required by claim 27? 08:53:35
`7 MR. BRAUSA: Objection; form. 08:53:39
`8 THE WITNESS: So since 27 depends on 26, my 08:53:41
`9 understanding is that this is a method of treating 08:53:48
`10 age-related macular degeneration and the patient need 08:53:53
`11 thereof, comprising sequential administration of a 08:53:56
`12 single dose of 2 milligrams of Aflibercept. 08:54:00
`13 And then 27 says: Wherein, only two secondary 08:54:03
`14 doses are administered to the patient and then 08:54:07
`15 followed by one or more tertiary doses of 2 milligrams 08:54:14
`16 of Aflibercept. 08:54:19
`17 And then you have the qualifier: And those 08:54:20
`18 doses, the tertiary doses, are given at eight weeks 08:54:24
`19 intervals. Each secondary dose is four weeks 08:54:27
`20 following immediate preceding dose. 08:54:30
`21 And then you have a qualifier for a visual 08:54:32
`22 result at the end. 08:54:35
`23 BY MR. NIMROD: 08:54:36
`24 Q. Okay. So for claim 27, the fixed regimen 08:54:36
`25 requires three initial doses that are a month apart and 08:54:42
`Page 8
`
`1 Q. You state in paragraph 64: It is my opinion 08:51:56
`2 based on the claims and specification of the 572 patent 08:52:00
`3 that a POSA would understand that challenged claims, 08:52:04
`4 specifically claim 15 and thereby claim 25, be limited 08:52:08
`5 to a predetermined fixed dosing schedules. 08:52:14
`6 Do you see that? 08:52:16
`7 A. Yes, I do. 08:52:17
`8 Q. And then on paragraph 74, you state -- seems more 08:52:18
`9 broadly, in the last sentence of paragraph 74. Are you 08:52:26
`10 with me? 08:52:29
`11 A. I see it. 08:52:30
`12 Q. It says: In my opinion -- it is my opinion that 08:52:30
`13 a POSA would see this as further evidence that the 572 08:52:33
`14 patent claims are drawn to predetermined fixed interval 08:52:37
`15 dosing regimens. 08:52:41
`16 Do you see that? 08:52:42
`17 A. I see it. 08:52:42
`18 Q. Is it your opinion that all the claims of the 572 08:52:43
`19 patent are directed to predetermined fixed interval 08:52:47
`20 dosing regimens? 08:52:52
`21 A. Yes, it is, it's my opinion. 08:52:56
`22 Q. So if we could turn to Exhibit 1, which is the 08:52:58
`23 patent, the 572 patent. And go to claim 27, claims near 08:53:02
`24 the end. You're already there. Good. 08:53:13
`25 Claim 27 depends from claim 26. And it requires 08:53:16
`Page 7
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`1 then followed by dosing every eight weeks till the end 08:54:44
`
`2 of treatment; is that right? 08:54:48
`
`3 MR. BRAUSA: Objection; form. 08:54:50
`
`4 THE WITNESS: So 27 when combined with 26 08:54:51
`
`5 requires three initial doses, a primary, two 08:54:56
`
`6 secondaries, and then followed by tertiary doses at 08:54:59
`
`7 eight-week intervals. 08:55:03
`
`8 BY MR. NIMROD: 08:55:04
`
`9 Q. And to be within the scope of claim 27, I think 08:55:05
`
`10 we talked about this last time, it's your opinion that 08:55:13
`
`11 if by happenstance or by treatment by PRN, a physician 08:55:16
`
`12 does not have a predetermined regimen but simply through 08:55:21
`
`13 observation of the patient decides on an ongoing basis 08:55:26
`
`14 to do first dose, two secondary doses and then have 08:55:30
`
`15 eight-week dosing after that, that would not fall within 08:55:35
`
`16 the scope of the claims; is that right? 08:55:37
`
`17 MR. BRAUSA: Objection; form. 08:55:39
`
`18 THE WITNESS: Would you repeat the question, 08:55:40
`
`19 please? You combined a couple of different factors 08:55:43
`
`20 there. 08:55:46
`
`21 BY MR. NIMROD: 08:55:46
`
`22 Q. Right. So if a physician does not have a 08:55:47
`
`23 predetermined dosing regimen, does that mean that the 08:55:48
`
`24 treatment does not fall within the scope of claim 27? 08:55:52
`
`25 MR. BRAUSA: Objection; form. 08:55:56
`
`Page 9
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`3 (Pages 6 - 9)
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`

`

`1 THE WITNESS: So my opinion, 27 requires a 08:55:57
`2 predetermined dosing regimen. 08:56:03
`3 BY MR. NIMROD: 08:56:08
`4 Q. If you could then turn to page 30 and 31 and just 08:56:08
`5 read paragraph 65 to yourself, please -- I'm sorry -- of 08:56:12
`6 your declaration. 08:56:16
`7 A. Okay. Paragraph 65? 08:56:17
`8 Q. Yes, please. 08:56:21
`9 A. Okay. 08:57:17
`10 Q. All right. On page 31, you -- sorry, go back to 08:57:18
`11 30. You say: Fixed regimens are those where doses are 08:57:23
`12 administered on a predetermined schedule regardless of 08:57:28
`13 observed outcomes at any given visit. 08:57:31
`14 Do you see that? 08:57:33
`15 A. Yes, I see that. 08:57:34
`16 Q. Okay. And then you go on and say that fixed 08:57:36
`17 regimens include monthly doses, as well as regimens 08:57:39
`18 involving a set number of loading doses all by dosing at 08:57:42
`19 longer fixed interval as described in the EYLEA label. 08:57:46
`20 Do you see that as well? 08:57:50
`21 A. Yes, I do. 08:57:51
`22 Q. And then you go on the next sentence and you say 08:57:52
`23 that: Sometimes adherence to the predetermined 08:57:55
`24 schedules in perfect regimens are still considered fixed 08:58:00
`25 when the intended dosing interval is based on a schedule 08:58:01
`Page 10
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`1 follows 26, my answer is no, in advance, you cannot 08:59:16
`2 predict the outcome of a given patient. 08:59:20
`3 Q. So does that mean that for claim 27, where you 08:59:24
`4 have a predetermined fixed schedule, that is not based 08:59:28
`5 on patient outcomes, as you're going along with the 08:59:34
`6 treatment, one would simply measure the outcome at 08:59:37
`7 52 weeks to see if a patient achieved the required gain 08:59:42
`8 or not; is that right? 08:59:47
`9 MR. BRAUSA: Objection; form. 08:59:48
`10 THE WITNESS: In order to meet -- in order to 08:59:51
`11 meet claim 26, then you would measure the outcome at 08:59:56
`12 week 52 to see if the claim were followed. In 09:00:02
`13 clinical practice, obviously that's not something you 09:00:06
`14 would consider. 09:00:09
`15 BY MR. NIMROD: 09:00:11
`16 Q. You wouldn't consider whether or not -- what the 09:00:11
`17 outcome was at 52 weeks in particular? Is that what you 09:00:13
`18 mean? 09:00:16
`19 A. You wouldn't -- 09:00:17
`20 MR. BRAUSA: Objection; form. 09:00:17
`21 THE WITNESS: You would not compare it to the 09:00:17
`22 claim. 09:00:22
`23 BY MR. NIMROD:
`24 Q. You would not compare it to -- how do you 09:00:24
`25 pronounce that again -- Ranibizumab? 09:00:28
`Page 12
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`1 rather than patient outcomes. 08:58:05
`2 Do you see that? 08:58:06
`3 A. Yes, I do. 08:58:07
`4 Q. What do you mean by rather than patient outcomes? 08:58:09
`5 MR. BRAUSA: Objection; form. 08:58:13
`6 THE WITNESS: By that, we mean that we adhere 08:58:14
`7 to the predetermined schedule and whether the patient 08:58:19
`8 has significant success, marginal success, we stick to 08:58:23
`9 the schedule, regardless of that and we do not use 08:58:30
`10 patient-determined data at the visit to modify the 08:58:34
`11 dosing. 08:58:38
`12 BY MR. NIMROD: 08:58:40
`13 Q. So then does that mean that if -- strike that. 08:58:41
`14 When you -- strike that again. 08:58:45
`15 If a physician decides to use a predetermined 08:58:49
`16 dosing regimen, as called for by claim 27 in the 572 08:58:51
`17 patent, does the physician know -- can the physician 08:58:55
`18 predict in advance whether an individual patient will 08:59:00
`19 have a specific outcome? 08:59:02
`20 MR. BRAUSA: Objection; form. 08:59:05
`21 THE WITNESS: You're speaking of treating with 08:59:07
`22 Aflibercept? 08:59:10
`23 BY MR. NIMROD: 08:59:10
`24 Q. Yes, I am. 08:59:10
`25 A. And according to claim 27, which, of course, 08:59:11
`Page 11
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`1 A. Ranibizumab. 09:00:30
`2 Q. Got it. Okay. So in actual clinical practice, 09:00:31
`3 you would not compare your patient's results to what the 09:00:36
`4 patient would have achieved with Ranibizumab -- 09:00:40
`5 MR. BRAUSA: Objection. 09:00:43
`6 BY MR. NIMROD: 09:00:43
`7 Q. -- for an individual patient? 09:00:44
`8 MR. BRAUSA: Objection; form. 09:00:45
`9 THE WITNESS: So in clinical practice, we have 09:00:46
`10 no way to know what that patient would have achieved 09:00:50
`11 had they received Ranibizumab instead of Aflibercept. 09:00:54
`12 BY MR. NIMROD:
`13 Q. So for claim 26, how would a physician know 09:01:01
`14 whether or not the -- let me strike that again. 09:01:09
`15 How would a -- for claim 26, how would a skilled 09:01:14
`16 artisan know whether they were practicing claim 26 and 09:01:18
`17 specifically know whether or not they had achieved a 09:01:24
`18 gain in visual acuity as compared to Ranibizumab? 09:01:26
`19 MR. BRAUSA: Objection; form. 09:01:32
`20 THE WITNESS: Well, if you look at the writing 09:01:33
`21 of 26, and you are concerned about meeting the claim, 09:01:38
`22 then you would compare it to the comparator, which is 09:01:43
`23 Ranibizumab, if you were worried about meeting the 09:01:47
`24 claim. 09:01:51
`25 BY MR. NIMROD: 09:01:52
`
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`4 (Pages 10 - 13)
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`Page 4
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`

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`1 Q. But the claim 26 and, therefore, claim 27 refer 09:01:52
`2 to treating a patient. Do you see that? 09:01:58
`3 A. Yes. 09:02:00
`4 Q. So for a patient, how would you determine, as a 09:02:00
`5 skilled artisan, whether you were practicing the 09:02:04
`6 method -- let me start over again, okay? 09:02:08
`7 All right. So let's say a physician decides to 09:02:10
`8 practice the dosing regimen that's required by claim 27, 09:02:15
`9 which is an initial dose, two secondary doses and then 09:02:20
`10 one month apart, and then tertiary doses that are eight 09:02:24
`11 weeks apart, do you follow me? 09:02:28
`12 A. Yes. 09:02:31
`13 Q. Okay. So a skilled person is then treating a 09:02:31
`14 patient following that regimen, that's required by claim 09:02:35
`15 27, how does the skilled person know whether the patient 09:02:39
`16 that they're treating meets the limitation -- limitation 09:02:44
`17 of wherein is as effective in achieving a gain in visual 09:02:49
`18 acuity as monthly administration of 0.5 milligrams of 09:02:53
`19 Ranibizumab by intravitreal injection in human subjects 09:02:58
`20 with age-related macular degeneration at 52 weeks 09:03:03
`21 following the initial dose? 09:03:09
`22 MR. BRAUSA: Objection; form. 09:03:11
`23 THE WITNESS: So let me answer that two ways. 09:03:12
`24 So one, the physician would not know what might have 09:03:19
`25 happened if Ranibizumab had been used instead of 09:03:22
`Page 14
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`1 BY MR. NIMROD: 09:05:14
`2 Q. So in order to meet the method of claim 27, the 09:05:14
`3 patient would have to achieve at least 8.1 in terms of 09:05:17
`4 improved visual acuity? 09:05:23
`5 MR. BRAUSA: Objection. 09:05:25
`6 BY MR. NIMROD: 09:05:25
`7 Q. Is that right? 09:05:26
`8 MR. BRAUSA: Objection; form. 09:05:26
`9 THE WITNESS: So treated, according to 26 and 09:05:28
`10 27, with Aflibercept, patient would -- at 52 weeks, 09:05:30
`11 would have to meet eight letters. We don't measure at 09:05:35
`12 point 1. 09:05:41
`13 BY MR. NIMROD: 09:05:43
`14 Q. You also said in your answer, you get the results 09:05:44
`15 that you get. What -- let me start over again. 09:05:53
`16 In your answer, you said you get the results that 09:05:57
`17 you get at 52 weeks. What did you mean by that? 09:05:59
`18 A. Sort of a colloquial way of saying it. You treat 09:06:03
`19 according to your regimen. And the results you end up 09:06:08
`20 with are what you end -- are what you have for that 09:06:11
`21 patient. You have no way of comparing to a different 09:06:14
`22 regimen that could have been used or a different drug 09:06:19
`23 that could have been used. 09:06:21
`24 Q. And when you say you get what you get, if you're 09:06:24
`25 practicing the method of claim 27, that means that you 09:06:26
`Page 16
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`1 Aflibercept. So you get the results that you get. 09:03:27
`2 Secondly, if you're looking to know, does it 09:03:33
`3 meet the claim, then you look at the data -- you look 09:03:35
`4 at the monthly -- the expected visual acuity results 09:03:42
`5 at 52 weeks with monthly Ranibizumab. 09:03:46
`6 BY MR. NIMROD:
`7 Q. And what is the expected visual acuity results at 09:03:50
`8 52 weeks for monthly Ranibizumab? 09:03:56
`9 A. So my understanding is that comes from the 09:03:59
`10 specifications. And that comes -- and that comes from 09:04:03
`11 table 1 in the specifications. And in table 1, there 09:04:09
`12 are two numbers. Column 15. 09:04:16
`13 Q. I'm there. Yeah. 09:04:22
`14 A. Yeah. So 8.1 and 9.4. Those are derived from 09:04:24
`15 two parallel similarly structured studies. 09:04:28
`16 Q. So is it your opinion that in order for a method 09:04:31
`17 to fall within the scope of claim 27, there has to be a 09:04:38
`18 mean improvement in visual acuity of 8.1 or 9.4? 09:04:44
`19 MR. BRAUSA: Objection; form. 09:04:51
`20 THE WITNESS: So if treating with Aflibercept 09:04:51
`21 according to the specifications in 26 and 27, then my 09:04:55
`22 understanding is it has to meet those numbers. Now, 09:04:59
`23 we can argue is it 8.1, is it 9.4, but that's the 09:05:03
`24 comparator for Ranibizumab that's specified in the 09:05:09
`25 claim. 09:05:13
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`Page 15
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`1 don't have a way of predicting whether or not you're 09:06:29
`2 going to be above or below the baseline for Ranibizumab 09:06:31
`3 of eight letter gains; is that right? 09:06:34
`4 A. So you're saying -- 09:06:36
`5 MR. BRAUSA: Objection; form. 09:06:39
`6 THE WITNESS: That if you treat according to 09:06:43
`7 the specifications in claims 26 and 27, that there's 09:06:44
`8 no way in advance to know if your 52-week visual 09:06:47
`9 acuity result is going to be above or below the 09:06:52
`10 comparator, which is Ranibizumab result. 09:06:54
`11 BY MR. NIMROD: 09:06:58
`12 Q. And you agree with that? 09:06:58
`13 A. As I stated it, yeah. Well, as I stated it, yes. 09:07:00
`14 Q. You stated it better. Let me just repeat that, 09:07:05
`15 then. 09:07:12
`16 A. Okay.
`17 Q. It's your opinion that if you treat according to 09:07:12
`18 the dosing regimen of claims 27, I'll say, there's no 09:07:16
`19 way to know in advance if you're going to meet the 09:07:18
`20 52-week visual acuity result that is going to be above 09:07:22
`21 or below the comparator, which is Ranibizumab; is that 09:07:27
`22 right? 09:07:30
`23 A. Treating with Aflibercept, yes. That's correct. 09:07:30
`24 Q. And when I say claim 27, that -- of course, that 09:07:34
`25 always requires Aflibercept, just -- 09:07:38
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`Samsung Bioepis Exhibit 1076
`Page 5
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`

`

`1 A. I know. I understand. Because it's included in 09:07:40
`2 26. 09:07:43
`3 Q. Right. Okay. And so if you're practicing the 09:07:43
`4 method of claim 27, there's no discretion with respect 09:07:49
`5 to practicing that claim as to modifying the dosing 09:07:56
`6 regimens in terms of the number of secondary doses and 09:08:00
`7 the spacing between the weeks of administration; is that 09:08:04
`8 right? 09:08:09
`9 MR. BRAUSA: Objection; form. 09:08:09
`10 THE WITNESS: If you're practicing according to 09:08:11
`11 the claim, then the dose is fixed, and you don't 09:08:14
`12 modify or you don't change from the fixed dosing. 09:08:18
`13 BY MR. NIMROD:
`14 Q. Thank you. All right. So now, let's turn to 09:08:22
`15 claim 1 of the 572 patent. Claim 1 is a method of 09:08:26
`16 treating an angiogenic eye disorder in a patient in need 09:08:42
`17 thereof. 09:08:46
`18 Do you see that? 09:08:47
`19 A. I do. 09:08:47
`20 Q. And it requires a sequential administration of an 09:08:48
`21 IV injection of a single dose of 2 mg of Aflibercept; is 09:08:56
`22 that right? 09:09:02
`23 A. Intravitreal and intravenous, yes. 09:09:03
`24 Q. Oh, intravitreal, thank you. 09:09:05
`25 And then it says: Followed by one or more 09:09:07
`Page 18
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`1 BY MR. NIMROD:
`2 Q. So if a skilled person is practicing claim 1, is 09:10:29
`3 the regimen fixed in advance such that there's no 09:10:33
`4 discretion as to how many secondary and how many 09:10:38
`5 tertiary doses are administered? 09:10:42
`6 MR. BRAUSA: Objection; form. 09:10:46
`7 THE WITNESS: So the predetermination is the 09:10:47
`8 number of doses given. If there is no 09:10:52
`9 predetermination or if the treatment regimen is 09:10:55
`10 changed because of an observation of the patient, then 09:11:00
`11 the physician is now practicing an individualized and 09:11:05
`12 not a predetermined fixed regimen. 09:11:09
`13 BY MR. NIMROD:
`14 Q. So could you describe how a physician would 09:11:13
`15 practice claim 1, be within the scope that it's not PRN? 09:11:15
`16 MR. BRAUSA: Objection. 09:11:21
`17 BY MR. NIMROD: 09:11:21
`18 Q. Give me an example. 09:11:22
`19 MR. BRAUSA: Objection; form. 09:11:22
`20 THE WITNESS: So I'm -- by you're -- you're 09:11:23
`21 saying is, is not PRN, so I'm interpreting that as how 09:11:29
`22 would a physician practice that as a fixed regimen. 09:11:34
`23 So the fixed regimen, an example, would be a physician 09:11:38
`24 would say, I'm going to start by giving a primary 09:11:43
`25 dose, I'm going to then give two secondary doses, and 09:11:46
`Page 20
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`1 secondary doses and one or more tertiary doses. 09:09:10
`
`1 then I'm going to switch after that to tertiary doses, 09:11:50
`
`2 Do you see that? 09:09:13
`
`2 which we're going to continue. 09:11:55
`
`3 A. Yes, I do. 09:09:13
`
`3 BY MR. NIMROD:
`
`4 Q. Okay. And then it goes on and says that each 09:09:14
`
`4 Q. Okay. And once the physician has made that 09:11:59
`
`5 secondary dose is administered approximately four weeks 09:09:19
`
`5 decision, then the regimen is fixed in the sense that it 09:12:02
`
`6 apart and that each tertiary is administered 09:09:21
`
`6 was for claim 27 going forward with no discretion based 09:12:06
`
`7 approximately every eight weeks apart. Is that right? 09:09:24
`
`7 on the patient outcomes along the way; is that right? 09:12:12
`
`8 A. Yes. 09:09:28
`
`8 MR. BRAUSA: Objection; form. 09:12:15
`
`9 Q. Now, in what sense is claim 1 a predetermined 09:09:28
`
`9 THE WITNESS: The -- if you meet the number of 09:12:16
`
`10 dosing regimen -- or let me strike that. 09:09:34
`
`10 doses, you eventually get to the point where you might 09:12:22
`
`11 In what sense is claim 1 a predetermined fixed 09:09:38
`
`11 elect to stop therapy or reassess. But as long as you 09:12:29
`
`12 dosing regimen? 09:09:42
`
`12 meet the number of doses here and in a predetermined 09:12:34
`
`13 MR. BRAUSA: Objection; form. 09:09:43
`
`13 fashion, then that's the fixed regimen. 09:12:38
`
`14 THE WITNESS: The claim -- claim 1 says you're 09:09:49
`
`14 THE VIDEOGRAPHER: Excuse me, can we go off the 09:12:42
`
`15 going to give your primary dose, then you're going to 09:09:51
`
`15 record? 09:12:45
`
`16 give a number of secondary doses and then followed by 09:09:53
`
`16 MR. NIMROD: Sure. 09:12:46
`
`17 tertiary doses at set intervals. 09:09:57
`
`17 THE VIDEOG