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` UNITED STATES PATENT AND TRADEMARK OFFICE
`
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`----------------------------------- )
`
`SAMSUNG BIOEPIS COMPANY, LTD., )
`
` Petitioner, )IPR NOS.
`
` vs. )2023-00739
`
`REGENERON PHARMACEUTICALS, INC. )2023-00884
`
` Patent Owner. )
`
`----------------------------------- )
`
` DEPOSITION OF RICHARD MANNING, Ph.D.
`
` WASHINGTON, D.C.
`
` MARCH 27, 2024
`
`REPORTED BY: Tina Alfaro, RPR, CRR, RMR
`
`Veritext Legal Solutions
`Calendar-CA@veritext.com 866-299-5127
`
`Page 1
`
`Samsung Bioepis Exhibit 1084
`Page 1
`
`

`

`1 I N D E X
`2 EXAMINATION
`3 WITNESS PAGE
`4 RICHARD MANNING, Ph.D.
`5 By Mr. Erwine 6
`6 EXHIBITS
`7 DEPOSITION EXHIBITS PAGE
`8 Exhibit 1001-A 14
` '572 Patent
`
`9
`
`Exhibit 1001 14
`10 '601 Patent
`11 Exhibit 2027 14
` Declaration of Michael Stewart, M.D.
`12 regarding '601 Patent
`13 Exhibit 2043 13
` Declaration regarding '601 Patent
`
`14
`
`Exhibit 2065 14
`15 Declaration of Michael Stewart M.D.
` regarding '572 Patent
`
`16
`
`Exhibit 2067 13
`17 Declaration regarding '572 Patent
`18 Exhibit 2172 86
` DME Market Assessment Quarter 3 2017
`
`19
`
`Exhibit 2224 91
`20 Wet AMD Physician ATU Q4 2017
`21
`22
`23
`24
`25
`
`1 Videotaped deposition of
`2 RICHARD MANNING, Ph.D., held at the offices of:
`
`3 4
`
` ARNOLD & PORTER KAYE SCHOLER, LLP
`5 601 Massachusetts Avenue, NW
`6 Washington, D.C. 20001
`
`7 8
`
` Taken pursuant to notice before Tina M.
`9 Alfaro, a Notary Public within and for the District
`10 of Columbia.
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`Page 2
`
`Page 4
`
`1 THE VIDEOGRAPHER: Good morning. We are 09:05:23
`2 going on the record at 9:05 a.m. on March 27, 2024. 09:05:24
`3 Please note that the microphones are sensitive and 09:05:30
`4 may pick up whispering and private conversations. 09:05:32
`5 Please mute your phones at this time. Audio and 09:05:36
`6 video recording will continue to take place unless 09:05:38
`7 all parties agree to go off the record. 09:05:41
`8 This is media unit 1 of the video-recorded 09:05:44
`9 deposition of Dr. Richard Manning in the matter of 09:05:46
`10 Samsung Bioepis Company, Ltd. versus Regeneron 09:05:51
`11 Pharmaceuticals, Inc. filed in the United States 09:05:56
`12 Patent and Trademark Office before the Patent Trial 09:05:59
`13 and Appeal Board, Case No. IPR-203 -- excuse me -- 09:06:03
`14 2023-00884. 09:06:07
`15 My name is Orson Braithwaite representing 09:06:12
`16 Veritext Legal Solutions, and I'm the videographer. 09:06:15
`17 The court reporter is Tina Alfaro from the firm 09:06:16
`18 Veritext Legal Solutions. 09:06:19
`19 Counsel will now state their appearances 09:06:20
`20 and affiliations for the record. 09:06:23
`21 MR. ERWINE: Richard Erwine of Quinn 09:06:25
`22 Emanuel on behalf of the Petitioner Samsung 09:06:28
`23 Bioepis. With me is my colleague Mr. Elliot Choi. 09:06:31
`24 MR. WILK: Matthew Wilk of Arnold & Porter 09:06:37
`25 on behalf of Patent Owner Regeneron. With me is my 09:06:40
`Page 5
`
`2 (Pages 2 - 5)
`
`1 APPEARANCES:
`2 ON BEHALF OF THE PETITIONER:
`3 QUINN EMANUEL URQUHART & SULLIVAN, LLP
`4 BY: RICHARD ERWINE, ESQ.
`5 ELLIOT CHOI, ESQ.
`6 51 Madison Avenue, 22nd Floor
`7 New York, NY 10010
`
`8 9
`
` ON BEHALF OF THE PATENT OWNER:
`10 ARNOLD & PORTER KAYE SCHOLER, LLP
`11 BY: MATTHEW WILK, ESQ.
`12 DAVID CAINE, ESQ.
`13 250 West 55th Street
`14 New York, NY 10019
`15 and
`16 MORRISON FOERSTER
`17 BY: DREW HILLIER, ESQ.
`18 12531 High Bluff Drive, Suite 100
`19 San Diego, CA, 92130-2040
`20
`21 ALSO PRESENT: Orson Braithwaite (videographer)
`22
`23
`24
`25
`
`Page 3
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`Veritext Legal Solutions
`Calendar-CA@veritext.com 866-299-5127
`
`Samsung Bioepis Exhibit 1084
`Page 2
`
`

`

`1 colleague David Caine. Also joining is Drew 09:06:44
`2 Hillier from the law firm of Morrison & Foerster 09:06:47
`3 and remotely is Eileen Woo from Regeneron. 09:06:52
`4 THE VIDEOGRAPHER: Thank you. 09:06:54
`5 Will you the court reporter please swear 09:06:55
`6 in the witness. 09:06:57
`7 (Witness sworn.) 09:07:04
`8 WHEREUPON: 09:07:04
`9 RICHARD MANNING, Ph.D., 09:07:04
`10 called as a witness herein, having been first duly 09:07:04
`11 sworn, was examined and testified as follows: 09:07:04
`12 EXAMINATION 09:07:04
`13 BY MR. ERWINE: 09:07:07
`14 Q. Good morning. Could you please state your 09:07:07
`15 name for the record. 09:07:09
`16 A. My name is Richard Manning. 09:07:10
`17 Q. And is it okay if I refer to you as 09:07:12
`18 Dr. Manning today? 09:07:15
`19 A. Sure. 09:07:16
`20 Q. Excellent. 09:07:17
`21 Dr. Manning, is there anything restricting 09:07:21
`22 you from providing complete and truthful testimony 09:07:23
`23 today? 09:07:23
`24 A. No. 09:07:23
`25 Q. Are you taking any medication that would 09:07:25
`Page 6
`
`1 impede your ability to provide complete and 09:07:27
`2 truthful testimony? 09:07:30
`3 A. No. 09:07:32
`4 Q. And Dr. Manning, I understand you've been 09:07:33
`5 deposed a number of times before? 09:07:37
`6 A. Yes. 09:07:38
`7 Q. Do you recall how many? 09:07:38
`8 A. Not exactly. Probably between 15 and 20, 09:07:40
`9 but I don't know the exact number. 09:07:43
`10 Q. And do you recall how many times you've 09:07:45
`11 been deposed with respect to the Regeneron/Samsung 09:07:47
`12 disputes at the PTAB? 09:07:53
`13 A. Regeneron/Samsung, I'd have to go back and 09:07:55
`14 look. I've been deposed by -- on Regeneron matters 09:07:58
`15 at the PTAB for different Petitioners. I don't 09:08:03
`16 remember the exact number. 09:08:08
`17 Q. And with respect to those depositions, the 09:08:11
`18 ones concerning Regeneron, did you review your 09:08:14
`19 deposition transcripts after the depositions to 09:08:20
`20 check for any errors? 09:08:22
`21 A. Yes. 09:08:24
`22 Q. And did you find any? 09:08:24
`23 A. I submitted errata for each of them. 09:08:27
`24 Nothing major, but I did have erratas for each of 09:08:30
`25 them. 09:08:34
`
`Page 7
`
`1 Q. Okay. And I think you -- in your CV 09:08:35
`2 you've indicated that you've testified a few times 09:08:38
`3 at trial; is that correct? 09:08:39
`4 A. Yes. 09:08:41
`5 Q. And is that -- have you testified at the 09:08:41
`6 PTAB for purposes of an IPR petition? 09:08:43
`7 A. So my understanding is that there is no 09:08:45
`8 live testimony at the PTAB, but I've submitted 09:08:47
`9 several declarations before the PTAB. 09:08:50
`10 Q. And how about District Court? 09:08:54
`11 A. I've testified in District Court four or 09:08:55
`12 five times. I'd have to, again, go back and look. 09:08:58
`13 Q. And were those patent cases? 09:08:59
`14 A. No. 09:09:01
`15 Q. Do you recall the general subject matter 09:09:02
`16 of those cases? 09:09:04
`17 A. Commercial litigation of various kinds. 09:09:05
`18 Q. And I think that you may have said this 09:09:12
`19 already, but you -- you've provided several 09:09:15
`20 declarations concerning the purported commercial 09:09:20
`21 success of Eylea? 09:09:25
`22 A. Yes, I have. 09:09:27
`23 Q. And do you recall how many declarations 09:09:28
`24 you've submitted with respect to commercial success 09:09:30
`25 of Eylea? 09:09:35
`
`Page 8
`
`1 A. I would have to go count them on my CV. 09:09:36
`2 They're reflected on my CV. I believe it's six or 09:09:38
`3 seven, maybe five, in that neighborhood. 09:09:42
`4 Q. Do all of those declarations relate to the 09:09:45
`5 dosing regimen of Eylea? 09:09:47
`6 A. Generally the dosing regimen is an 09:09:51
`7 important element. It's not the only element that 09:09:54
`8 I discuss, but it is an important element. 09:10:00
`9 Q. Do you recall any of the other elements 09:10:02
`10 you discussed? 09:10:03
`11 A. Well, the elements that were at issue in 09:10:05
`12 each of the proceedings. I'd have to go back and 09:10:07
`13 look at those reports and verify, but dosing has 09:10:12
`14 been a very important one. 09:10:16
`15 Q. And do you recall the time period for 09:10:17
`16 which you submitted those declarations? 09:10:18
`17 A. I believe the first one was a couple years 09:10:21
`18 ago. Again, my CV reflects the exact date. 09:10:22
`19 Q. Would it be fair to say it was February of 09:10:27
`20 2022; does that sound right? 09:10:29
`21 A. If that's what my -- if that's what the 09:10:31
`22 record reflects. I don't remember the exact date. 09:10:34
`23 Q. And Dr. Manning, have your views changed 09:10:37
`24 at all over that time period with respect to the 09:10:43
`25 commercial success of Eylea? 09:10:46
`
`Page 9
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`3 (Pages 6 - 9)
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`Samsung Bioepis Exhibit 1084
`Page 3
`
`

`

`1 A. No. 09:10:49
`2 Q. So if I were to go back and look at one of 09:10:49
`3 your deposition transcripts or one of your 09:10:51
`4 declarations from a couple years ago, there isn't 09:10:53
`5 anything in there that you'd want to modify or 09:10:55
`6 change? 09:10:57
`7 A. Not that I'm aware of, no. 09:10:58
`8 Q. What did you do to prepare for today's 09:11:04
`9 deposition? 09:11:06
`10 A. I reviewed my declarations. I understand 09:11:07
`11 there are two declarations at issue here and I 09:11:09
`12 reviewed each of those. I reviewed Dr. Stewart's 09:11:13
`13 declarations. I reviewed some of the materials 09:11:17
`14 that I had used before or for -- in preparing the 09:11:20
`15 declaration. I reviewed -- I believe I reviewed my 09:11:26
`16 last deposition transcript. I met with counsel. 09:11:31
`17 Q. And when you say your last deposition 09:11:36
`18 transcript, do you recall which patent that was 09:11:38
`19 for? 09:11:40
`20 A. I'm sorry. I'm not remembering the number 09:11:42
`21 off the top of my head. Again, it's on my CV and 09:11:49
`22 in the record, but it was the one that was in 09:11:52
`23 December I believe. 09:11:55
`24 Q. The '681 Patent, does that sound close? 09:11:58
`25 A. I would want to make sure I looked at the 09:12:01
`Page 10
`
`1 Q. Okay. Great. 09:12:55
`2 And Dr. Manning, did you speak to anyone 09:12:57
`3 in preparation for today's deposition? 09:12:59
`4 A. Counsel, my staff. No one else that I 09:13:03
`5 recall. 09:13:08
`6 Q. So, for instance, did you speak to 09:13:09
`7 Dr. Stewart at all in preparation for today's 09:13:12
`8 deposition? 09:13:14
`9 A. Not in preparation for the deposition, 09:13:15
`10 no. 09:13:19
`11 Q. And you mentioned that you spoke to 09:13:19
`12 counsel. Did you meet with them in person? 09:13:20
`13 A. Yes. 09:13:22
`14 Q. And when was that? 09:13:23
`15 A. Yesterday. 09:13:24
`16 Q. And who did you meet with? 09:13:25
`17 A. The gentlemen here at the table. 09:13:27
`18 Q. And how long did you meet for? 09:13:29
`19 A. Three hours perhaps, the morning. 09:13:33
`20 Q. And you mentioned staff that you may have 09:13:38
`21 spoken to in preparation. Who on your staff did 09:13:40
`22 you speak to? 09:13:43
`23 A. Ryan Marsh. He's a Ph.D. economist that 09:13:44
`24 works for Intensity. 09:13:49
`25 Q. When you did speak to him? 09:13:50
`Page 12
`
`1 record to be certain. 09:12:03
`2 Q. Okay. And do you recall, would it have 09:12:04
`3 been my colleague -- 09:12:05
`4 A. Yes. 09:12:06
`5 Q. -- Mr. Choi that took the deposition? 09:12:06
`6 A. Yes. 09:12:09
`7 Q. Okay. Great. 09:12:09
`8 Now, you mentioned that you reviewed was 09:12:11
`9 it two declarations, that's the '572 and '601 09:12:14
`10 declarations that are at issue today? 09:12:19
`11 A. Yes. 09:12:22
`12 Q. Did you review any other declarations in 09:12:22
`13 preparation for today's deposition? 09:12:23
`14 A. I don't believe so, no. 09:12:25
`15 Q. I think you mentioned that you reviewed 09:12:26
`16 Dr. Stewart's declarations? 09:12:29
`17 A. Stewart? 09:12:32
`18 Q. Yes. Was it just his declarations for the 09:12:33
`19 '572 and '601 Patents? 09:12:36
`20 A. Yes. 09:12:41
`21 Q. And I think you indicated some materials 09:12:41
`22 that you have used that were part of your two 09:12:43
`23 declarations; is that correct? 09:12:45
`24 A. In the appendices or the attachments to my 09:12:50
`25 declarations, those are what I reviewed. 09:12:53
`Page 11
`
`1 A. Yesterday and I may have talked to him a 09:13:51
`2 couple days before, but intermittently throughout 09:13:53
`3 the last few days. 09:13:56
`4 Q. Was he part of the meeting with counsel 09:13:59
`5 yesterday? 09:14:01
`6 A. No. Oh yes, he was. Yeah. He was 09:14:04
`7 remote, but he was not physically there. 09:14:05
`8 Q. And did you -- and apologies if I'm going 09:14:11
`9 too fast. Did you speak to Mr. Marsh independently 09:14:11
`10 of your meeting with counsel? 09:14:13
`11 A. Yes. 09:14:16
`12 Q. When was that? 09:14:16
`13 A. Intermittently. 09:14:19
`14 Q. All right. 09:14:29
`15 So let me give you some documents to start 09:14:29
`16 the day. I think many of these have already been 09:14:31
`17 designated as exhibits. The first exhibit I'm 09:14:36
`18 going to hand you is Exhibit 2067. This is your 09:14:38
`19 declaration concerning the '572 Patent. So that's 09:14:45
`20 from the case IPR-2023-884. 09:14:50
`21 I'm also going to hand you your 09:15:05
`22 declaration from -- or for the '601 Patent and that 09:15:08
`23 is Exhibit 2043, IPR-2023-739. We'll get these 09:15:17
`24 all knocked out to begin with. 09:15:42
`25 I'm going to hand you this is United 09:15:44
`
`Page 13
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`4 (Pages 10 - 13)
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`Samsung Bioepis Exhibit 1084
`Page 4
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`

`

`1 States Patent No. 11,253,572, and it's 09:15:49
`2 Exhibit 1001 and I believe it's just from the 09:15:53
`3 '572 IPR. And also United States Patent 09:16:00
`4 No. 10,888,601, which is Exhibit 1001 from the 09:16:16
`5 '601 IPR. And let's just do them all. 09:16:26
`6 This is Exhibit 2027. This is the 09:16:49
`7 declaration of Michael W. Stewart, M.D., and this 09:16:54
`8 is for the '601 Patent and I believe this is just 09:17:01
`9 from the '601 IPR, which is 739. We're killing a 09:17:05
`10 lot of trees here. 09:17:12
`11 And last but not least, this is the 09:17:18
`12 declaration of Michael W. Stewart for the 09:17:21
`13 '572 Patent, this is Exhibit 2065 and it's just 09:17:25
`14 in the '572 IPR, which is the 884 IPR. 09:17:31
`15 Now, Dr. Manning, I was going to start 09:17:54
`16 with your '572 IPR declaration and before I get 09:17:57
`17 started, so there appears to be a lot of similarity 09:18:03
`18 between the '572 and the '601 declarations. Is 09:18:07
`19 that your understanding? 09:18:13
`20 A. Yes. 09:18:14
`21 Q. I think a lot of my questions are probably 09:18:14
`22 going to overlap on the two. So is that all right 09:18:15
`23 with you if I combine some of those questions, or 09:18:21
`24 do you prefer that I go, you know, one by one in 09:18:24
`25 terms of the declarations? 09:18:28
`
`1 that particular matter? 09:20:14
`2 A. I don't. 09:20:15
`3 Q. Ballpark? 09:20:16
`4 A. You know, I haven't looked at the record 09:20:17
`5 and I really don't know. 09:20:19
`6 Q. Same for '601? 09:20:20
`7 A. Yeah. Same answer, yes. 09:20:24
`8 Q. Okay. In terms of your overall work for 09:20:27
`9 Regeneron, do you have a sense for overall hours, 09:20:29
`10 amount of time you spent? 09:20:34
`11 A. I don't know that either. 09:20:35
`12 Q. All right. 09:20:36
`13 In paragraph 8 you reference some work by 09:20:39
`14 other members of your team; do you see that? 09:20:42
`15 A. Yes. 09:20:46
`16 Q. Is Mr. -- is it Mr. or Dr. Marsh? 09:20:46
`17 A. Dr. Marsh. 09:20:50
`18 Q. Dr. Marsh, is he one of the members of 09:20:50
`19 your team? 09:20:53
`20 A. He is. 09:20:54
`21 Q. Do you know what his billing rate is? 09:20:54
`22 A. Off the top of my head I do not. 09:20:56
`23 Q. Okay. Are there other members of your 09:20:57
`24 team? 09:20:58
`25 A. Yes. 09:20:59
`
`Page 14
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`Page 16
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`1 A. I'm happy to have you ask the questions as 09:18:28
`2 you like. 09:18:31
`3 Q. Okay. Great. 09:18:31
`4 I guess first turning to paragraph 8 of 09:18:35
`5 your declaration and this is, again, the '572 09:18:37
`6 declaration, but I think it's hopefully similar. I 09:18:44
`7 wanted to ask you about your hourly rate. So in 09:18:49
`8 the '572 declaration it's listed at 1,150 an hour; 09:18:56
`9 is that right? 09:19:01
`10 A. That's correct. 09:19:01
`11 Q. In the '601 declaration it's listed as 09:19:03
`12 1,050 an hour. I'm just curious. Was that a typo 09:19:06
`13 or what was the reason for the difference? 09:19:11
`14 A. I believe that is because the '601 09:19:13
`15 declaration was completed in 2023. Let me look at 09:19:16
`16 the date to be sure I'm not getting this wrong. 09:19:27
`17 Well, it's good a thing that I checked the 09:19:39
`18 date because that specific statement is not quite 09:19:41
`19 accurate, but the work was done based on an 09:19:43
`20 earlier -- on the billing rates that were in place 09:19:48
`21 during 2023. My billing rate was changed as of the 09:19:52
`22 end of the year. So that would explain the 09:19:57
`23 difference. 09:20:00
`24 Q. And with respect to the '572 IPR, do you 09:20:04
`25 know about how many hours you've spent on that in 09:20:10
`Page 15
`
`1 Q. Who are those? 09:20:59
`2 A. Elizabeth Parker has worked on it, Max 09:21:01
`3 Allman -- Urman has worked on it, on these cases. 09:21:04
`4 I don't know who has spent the more time on each 09:21:06
`5 declaration. I haven't managed the workflow to the 09:21:10
`6 extent -- at the level of detail that would help me 09:21:20
`7 remember that -- the answer to that question. 09:21:23
`8 Q. And was there one of the members of your 09:21:27
`9 team that was particularly focused on either '572 09:21:29
`10 or '601? 09:21:34
`11 A. I believe they each focused on both 09:21:37
`12 reports. 09:21:39
`13 Q. Got it. 09:21:40
`14 A. Or both declarations. 09:21:41
`15 Q. So let me ask you turning to paragraph 10 09:21:42
`16 of your report. That is on page -- looks like it's 09:21:45
`17 on page 9 of the document. You indicate that you 09:21:53
`18 relied on the declaration of -- of Michael W. 09:21:59
`19 Stewart, M.D., Exhibit 2065; do you see that? 09:22:05
`20 A. Yes. 09:22:09
`21 Q. And you have that exhibit in front of you. 09:22:09
`22 A. Uh-huh. 09:22:13
`23 Q. You also mentioned you had a conversation 09:22:13
`24 with Dr. Stewart; is that right? 09:22:13
`25 A. Yes. 09:22:14
`
`Page 17
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`Samsung Bioepis Exhibit 1084
`Page 5
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`

`

`1 Q. When was that conversation? 09:22:14
`2 A. I don't remember the date. It was within 09:22:16
`3 the weeks leading up to the submission of the 09:22:22
`4 declaration. 09:22:24
`5 Q. Okay. So for this particular -- this 09:22:24
`6 declaration was signed in February of 2024; is that 09:22:28
`7 right? 09:22:32
`8 A. Yes, February 22nd. 09:22:36
`9 Q. Okay. So possibly sometime in February 09:22:38
`10 2024? 09:22:40
`11 A. Could be. I'd have to go back and look at 09:22:41
`12 my calendar, but I don't remember the exact date. 09:22:43
`13 Q. And what did you and Dr. Stewart talk 09:22:45
`14 about? 09:22:49
`15 A. We talked about the issues that I have 09:22:51
`16 mentioned in the declaration. There's a summary of 09:22:53
`17 the points that I took from him. We talked about, 09:22:56
`18 you know, his declaration, the main points of his 09:23:01
`19 declaration, those sorts of things. 09:23:03
`20 Q. And was that the only time you talked to 09:23:06
`21 him? 09:23:08
`22 A. I talked to him once for each of the 09:23:08
`23 declarations. 09:23:10
`24 Q. And do you recall for each the duration of 09:23:10
`25 those conversations? 09:23:14
`
`Page 18
`
`1 framework within which my economic analysis is 09:24:31
`2 done. 09:24:35
`3 Q. Okay. And in terms of setting forth that 09:24:37
`4 legal framework, is that based on a conversation 09:24:43
`5 you had with counsel, or how did you establish that 09:24:47
`6 framework? 09:24:51
`7 A. So I have understood the framework for 09:24:52
`8 commercial success for a number of years. I 09:24:57
`9 have -- I don't remember the exact conversation 09:25:02
`10 that took place for these particular declarations, 09:25:05
`11 but I know that in prior declarations I've 09:25:07
`12 discussed with counsel what the legal framework of 09:25:09
`13 commercial success is and those are very similar 09:25:15
`14 across -- well, those are the same. So I take 09:25:17
`15 those as -- essentially as instruction from 09:25:21
`16 counsel. 09:25:24
`17 Q. And in addition to discussion with 09:25:26
`18 counsel, did you review anything else to help you 09:25:28
`19 with this framework? 09:25:33
`20 A. Well, I do have some footnotes in those 09:25:36
`21 paragraphs. So those materials are things that 09:25:38
`22 I -- for these projects and prior projects relating 09:25:41
`23 to commercial success that I have looked at and 09:25:47
`24 come to understand the appropriate framework for an 09:25:52
`25 economic analysis of commercial success. 09:25:57
`Page 20
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`1 A. They were scheduled for half an hour. I 09:23:17
`2 don't recall whether they went the full time or 09:23:19
`3 not. 09:23:21
`4 Q. And were they by telephone? 09:23:21
`5 A. By electronic or Zoom. I don't know 09:23:24
`6 whether it was actually Zoom or some other method, 09:23:26
`7 but there was a video conversation. 09:23:30
`8 Q. And was anybody else present for those 09:23:32
`9 Zoom conferences? 09:23:34
`10 A. Counsel was there. 09:23:36
`11 Q. Got it. 09:23:37
`12 A. And Ryan Marsh may have been on as well. 09:23:40
`13 Q. Now, I want to ask you some questions 09:23:46
`14 about particularly paragraphs 11 and 12, and I 09:23:49
`15 believe those paragraphs are identical for both the 09:23:58
`16 '572 and '601. I'm not going to burden you with 09:24:02
`17 checking, but does that sound about right? 09:24:06
`18 A. That wouldn't surprise me. 09:24:11
`19 Q. All right. And is it fair to say that 09:24:12
`20 those -- paragraphs 11 and 12, those set forth the 09:24:15
`21 legal framework for your opinions? 09:24:20
`22 MR. WILK: Objection to form. 09:24:23
`23 A. Well, I wouldn't say that I have a legal 09:24:24
`24 opinion. I would say that they represent my 09:24:26
`25 understanding of the legal framework or the 09:24:28
`Page 19
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`1 Q. And as an example I think one of the cases 09:26:00
`2 that you footnote is -- looks like Demaco Corp 09:26:04
`3 versus F. Von Langsdorff from 1988; is that 09:26:09
`4 correct? 09:26:14
`5 A. That is one of the citations, yes. 09:26:15
`6 Q. Merck v. Teva from 2005? 09:26:17
`7 A. That's one of the citations, yes. 09:26:21
`8 Q. And you've got a reference to a citation 09:26:22
`9 from the Manual of Patent Examining Procedure; is 09:26:27
`10 that right? 09:26:33
`11 A. Yes. 09:26:34
`12 Q. And it also looks like Yita v. MacNeil 09:26:34
`13 from 2023? 09:26:36
`14 A. Yes. 09:26:39
`15 Q. Ormco Corp versus Align from 2006? 09:26:39
`16 A. That's correct. 09:26:42
`17 Q. And then it looks like you have a number 09:26:43
`18 of citations to an article from 2009 that is titled 09:26:45
`19 "The Economics of Commercial Success in 09:26:52
`20 Pharmaceutical Patent Litigation"; is that right? 09:26:55
`21 A. There are two, yes. 09:26:57
`22 Q. Got it. You said there are two citations, 09:27:02
`23 but it's the same article, right? 09:27:04
`24 A. Yes. 09:27:09
`25 Q. Now, in paragraph 11 of your declaration 09:27:09
`Page 21
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`Veritext Legal Solutions
`Calendar-CA@veritext.com 866-299-5127
`
`6 (Pages 18 - 21)
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`Samsung Bioepis Exhibit 1084
`Page 6
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`

`

`1 you indicate that you understand that for 09:27:13
`2 commercial success to constitute evidence of 09:27:15
`3 nonobviousness of a patent there must be a nexus 09:27:19
`4 between the claimed technology and evidence of 09:27:24
`5 commercial success; do you see that? 09:27:27
`6 A. I do see that. 09:27:29
`7 Q. All right. So before I get to that let me 09:27:31
`8 ask you, are you aware of the burden that is on the 09:27:33
`9 patent owner with respect to establishing 09:27:37
`10 commercial success for purposes of secondary 09:27:39
`11 considerations? 09:27:42
`12 MR. WILK: Objection to form. 09:27:43
`13 A. That's a legal issue. You know, I have 09:27:44
`14 some general understanding of it, but I don't 09:27:48
`15 actually know the details of who owns -- who has 09:27:50
`16 the burden of demonstrating what, no. 09:27:54
`17 Q. Okay. So you don't know, first of all, 09:27:56
`18 who has the burden? 09:27:57
`19 MR. WILK: Objection to form. 09:27:59
`20 A. As I sit here I'm not recalling that, no. 09:27:59
`21 Q. All right. And so setting aside who has 09:28:03
`22 the burden, you also don't know what the standard 09:28:05
`23 is, in other words, what's required to prove it? 09:28:08
`24 MR. WILK: Objection to form. 09:28:10
`25 A. The legal standard I don't recall. 09:28:15
`
`Page 22
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`1 Q. Okay. You said you had some general 09:28:19
`2 understanding about the legal iss