`Cass 2P2AcQOOUOnI-SENAMM Dinousmbas2hetOEes Pape 0412582?Pahaiett 68538
`PagelD #: 29029
`
`Exhibit 24
`
`
`
`Case 1:22-cv-00061-TSK-JPM Document 624 Filed 09/01/23 Page 2 of 56 PageID #: 48179
`Cased 222200065:SKHIAVM Docamenh6422 PietHiS0HR3 Page 2OF5Pavalih # ABIGF9
`PagelD #: 29030
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`Page 1
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`IN THE UNITED STATES DISTRICT COURT
`
`FOR THE NORTHERN DISTRICT OF WEST VIRGINIA
`
`AT CLARKSBURG
`
`REGENERON PHARMACEUTICALS,
`
`INC.,
`
`Plaintiff,
`
`Case No.
`
`-versus—
`
`1:22-cv—-00061-TSK
`
`MYLAN PHARMACEUTICALS INC.,
`
`Defendant.
`
`***ATGHLY CONFIDENTIAL***
`
`January 18, 2023
`9:12 a.m.
`
`VIDEOTAPED DEPOSITION of GEORGE D.
`
`taken pursuant to Notice, held at
`YANCOPOULOS,
`Westchester Marriott, 670 White Plains Road,
`
`Tarrytown, New York, before Fran Insley, a
`Notary Public of the States of New York and New
`
`Jersey.
`
`“al
`
`oO
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`Ll?
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`www.veritext.com
`
`888-391-3376
`
`Veritext Legal Solutions
`
`
`
`Case 1:22-cv-00061-TSK-JPM Document 624 Filed 09/01/23 Page 3 of 56 PageID #: 48180
`Cased 222200005:SKKIAVM Docamenh6422 fiethIS0HR3 Page 8OP5&Pagaliz & 48160
`PagelD #: 29031
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`Page 2
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`Page 4
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`1APPEARANCES:
`2
`WILLIAMS & CONNOLLY
`3
`Attorneys for Plaintiff and
`4
`Witness
`5
`680 Maine Avenue, 5.W.
`6
`Washington, D.C. 20024
`7
`BY: DAVID BERL, ESQ.
`8
`ELLEN OBERWETTER, ESQ.
`9
`-and-
`10
`KATHRYN KAYALI, ESQ.
`1]
`12
`13
`14
`15
`16
`17
`18
`19
`20
`
`CAREY DOUGLAS KESSLER & RUBY PLLC
`Attorneys for Plaintiff
`707 Virginia Street East
`901 Chase Tower
`Charleston, West Virginia 25301
`BY: DAVID R. POGUE, ESQ.
`(via teleconference)
`drpogue@cdkrlaw.com
`
`2]
`22
`23
`24
`
`25
`
`-eeseeeereneee DN DE X --c0enececnenerer
`1
`PAGE
`2 WITNESS
`EXAMINATION BY
`3 GEORGE YANCOPOULOS MS. MAZZOCHI
`
`7
`
`PAGE
`
`4 §
`
`-------------E X HI BIT 8---------------
`6 DEPOSITION
`DESCRIPTION
`
`51
`7 Exhibit 900 Objections to Interrogatories
`8 Exhibit 901 RGN-EYLEA-MYLAN00487461 to 503 54
`
`9 Exhibit 902 RGN-EYLEA-MYLAN0054862 to 863
`
`68
`
`10 Exhibit 903 MYL-AFL5190 through 5215
`11 Exhibit 904 MYL-AFL5216 through 5241
`12 Exhibit 905 Patent 61/432245 application
`13
`
`75
`74
`
`87
`
`14 (The following exhibits were not referred to in
`14 the deposition:
`16 Exhibit 906 MYL-AFL90927 through 953
`17 Exhibit 907 MYL-AFL90954 through 980
`18 Exhibit 908 MYL-AFL91108
`
`19 Exhibit 909 RGN-EYLEA-MYLANI3557 through
`20 13602)
`21 Exhibit 910 RGN-EYLEA-MYLAN13909 to 917
`22 Exhibit 911 RGN-EYLEA-MYLAN13628 to 629
`23 Exhibit912 RGN-EYLEA-MYLAN]13918 to 929
`
`119
`121
`125
`
`24 Exhibit 913 RGN-EYLEA-MYLANS525081 TO 083 135
`25 Exhibit 914 MYL-AFL91250 to 273
`139
`
`PAGE
`DESCRIPTION
`1 DEPOSITION
`2 Exhibit 915 RGN-EYLEA-MYLAN501 236to 248
`
`3 Exhibit 916 RGN-EYLEA-MYLAN493989 to 994
`4 Bxhibit 917 RGN-EYLEA-MYLAN504696to 693
`5 Exhibit918 RGN-EYLEA-MYLAN4952807 to 852
`6 Exhibit919 RGN-EYLEA-MYLAN539067 to 068
`
`Page 5
`
`153
`
`179
`187
`203
`206
`
`197
`
`24
`24
`
`(EXHIBITS PRODUCED.)
`7
`8 Exhibit 5204 Previously marked.
`9 Bxhibit 4 '601 Patent
`10 Exhibit 5 '572 Patent
`11
`12
`13
`14
`15
`16
`17
`
`MATTHEW CHIN-QUEE,Videographer
`
`APPEARANCES. (Continued)
`RAKOCZY MOLINO MAZZZOCHI SIWIK LLP
`
`Page 3
`
`Attormeys for Defendant
`6 West Hubbard Street
`Suite 500
`
`Chicago, Illinois 60654
`BY: DEANNE MAZZOCHLESQ.
`LAUREN LESKO,ESQ.
`-and-
`
`JEFFREY A. MARX, ESQ.
`(via teleconference)
`jmarx@rmmislegal.com
`AND
`
`STEPTOE & JOHNSON, LLP
`400 White Oaks Boulevard
`
`Bridgeport, West Virginia 26330
`BY: WILLIAM J. O'BRIEN, ESQ.
`(via teleconference)
`jamie.obrien@steptoe-johnson.com
`
`ALSO PRESENT:
`
`LARRY COURY,ESQ., Regeneron
`
`www.veritext.com
`
`Veritext Legal Solutions
`
`2 (Pages 2 - 5)
`
`888-391-3376
`
`
`
`Case 1:22-cv-00061-TSK-JPM Document 624 Filed 09/01/23 Page 4 of 56 PageID #: 48181
`Cased 22200066SKHERM Didcimecn6422PhethISi0He3 Paed 44P5ePagallt # 48381
`PagelD #: 29032
`
`Page 6
`9:12: 18AM
`THE VIDEOGRAPHER: Good moming. We
`are going on the record at 9:12 a.m on
`9:12: 19AM
`January 18, 2023,
`9:12;23AM
`This is media unit one ofthe
`9:12:26AM
`
`Page &
`$:14:26AM
`Q. Have you given any statements or
`j
`9:14:30AM
`2 swor testimony in any matter involving the US
`3 government and EYLEA?
`9:14:33AM
`4
`<A. No, Fhave not.
`9:14:40AM
`
`1
`2
`3
`4
`
`9:14:41AM
`QQ. Have you given any statements or
`5
`9:12:29AM
`videotaped deposition of George
`5
`9:14:44AM
`6 testimony involving any claims involving a
`9:12:31AM
` ¥ancopoulosin the matter Regeneron
`6
`
`7=Phammaceuticals Inc. v Mylan 9:12:35AM 7 state governmentrelating to kickback 9:14:47AM
`
`
`8
`Pharmaceuticals Inc, et. al. Case number
`9:12;38AM.
`8 allegations invalving EYLEA?
`9:14:49AM
`
`9=:1:22-CV-00061-TSK. The deposition is 9:12:42AM 9° A No, [have not. 9:14:53AM
`
`
`
`10—_beittg held at 670 White Plains Road, 9:12:524M 10° Q. Have you received any subpoenas to 9:14:56AM
`
`
`
`11
`Tarrytown, New York.
`9:12:57AM
`11 appear before a state or federal grand jury?
`$:14:58AM
`12
`My nameis Matthew Chin-Quee from
`9:13:01AM
`i2
`A. No, I have not.
`9:15:04AM
`13
`Veritext and I'm the videographer. The
`9:13:044M
`13.
`Q. Have you had any discussions
`9:15:054M
`14
`court reporter is Fran Insley from the
`9:13:07AM
`14 internally regarding the US Government's
`9:15:06AM
`15
`firm Veritext.
`9:13:09AM
`15 kickback lawsuit against Regeneron involving
`9:15:09AM
`16
`Will ali counsel please state your
`913:11AM
`ig EYLEA?
`$15; 2AM
`17
`appearances.
`9:13:13AM
`i7
`MR. BERLE: Objection. You can
`9:15:13AM
`18
`MS. MAZZOCHL Good moming. My
`18
`answer that yes or no.
`9:15:15AM
`19
`name is Deanne Mazzochi from thelaw firm
`19
`A. Lam not sure if [ heard of anything
`9:15:22AM
`20
`of Rakoczy Molio Mazzochi Siwik, LLP.
`20 referred to in the manner in which you just
`9:15:24AM
`21
`Also with me is Lauren Lesko.
`21 describedit.
`9:15:27AM
`
`$:13;144M
`9:13: 1SAM
`9:13:17AM
`9:13:19AM
`
`9:15:29AM
`Q. Are you aware of or have you spoken
`22
`9:13:23AM
`MR. BERL: David Berl, Wittiams &
`22
`9:15:31AM
`23 to anyone internally within Regeneron involving
`9;13;24AM
`Connolly on behalf of Regeneron and the
`23°
`
`24~~witness. With meare Ellen Oberwetter 9:1327AM 24 allegations by the US Government that of 9:15:35AM
`
`
`25
`from Williams & Connolly and Kathryn
`9:13:30AM
`25 Regeneran's misuse of the Chronic Disease Fund
`9:15:39AM
`
`9:13:32AM
`Kayali from Williams & Connolly and Larry
`Coury from Regeneron.
`913374M
`
`1 or improper payments by Regeneron to the
`2 Chronic Disease Fund?
`
`Page 7
`
`Page 9
`9:15:43AM
`9:13:454M
`
`THE VIDEOGRAPHER: Will the court
`reporter please swear in the witness,
`5 GEORGE YANCOPOULOS,the
`6 Witness herein, having first been duly swom by
`7 the Notary Public, was examined and testified
`
`9:13:39AM
`9: 13.40.4M
`S:1341AM
`13:41AM
`9:13:4L4M
`
`9:15:49AM
`MR. BERL: Objection. You can
`9:15:-494M
`answer that yes or no.
`9:15:55AM
`A. Tmaot sure that anything that Tim
`9:15:57AM
`6 aware of has been referred to in that way that
`7 you referredto it.
`9:16:004AM
`
`9:13:41AM
`8 as follows:
`9 EXAMINATION BY M8, MAZZOCHI:
`
`3,494M
`
`QQ Whaiis your understanding of the
`8
`9 Chronic Disease Fund?
`
`9:16:02AM
`9:16:034M
`
`9:16: 10AM
`A. Tm not an expert in this matter.
`id
`9:13:50AM
`Q. Good morning, Dr. Yancopoutos. Can
`10
`
`
`
`11 youplease state your full name and address for 11)3=Q9:13:52AM It doesn't matter. I'm not asking 9:16: 1LLAM
`
`12 the record?
`9;13:544AM
`12 for your expertise. I'm just asking for your
`9:16: 13AM
`
`
`
`George Damis Yancopoulos.
`Address?
`
`9:13:544M
`9:13:57AM
`
`13 factual knowledge about the Chronic Disease
`14 Fund.
`9:1]&:17AM
`
`9:16:16AM
`
`9:13:594AM
`Home address?
`re ee ee eeee re er er ee ee re re te
`Sure.
`9:14:00AM
`16
`i Regeneron Protected Material |
`NeaaneeaonaoeaoeaooaSSSmSSooow
`i
`;
`
`Q. Have you given testimony under oath
`19
`20 before?
`9:14:L LAM
`
`9:14:094AM
`
`21
`22
`
`9:14:13AM
`A No.
`0««Q.s Are you aware of the US Department
`
`23 ofJustice lawsuit against Regeneron involving
`24 EYLEA?
`9:14:20AM
`25° A ¥es,lam.
`9:14:25.4M
`
`$:14144AM
`
`9:14:16AM
`
`A. Factual knowledge?
`15
`9:16:2LAM
`i60«6©Q)
`«Right
`9:16:23AM
`17
`A. TmanotsureifTunderstand ——9:16:25AM
`i8
`Q. Do you know what the Chronic Disease
`9:16:28AM
`19 Fundis?
`9:16:29AM
`20
`A.
`[believe the Chronic Disease Fund
`9:16:40AM
`
`21 isa foundation that pays for the co-payments
`22 for certain medicines when patients cannot
`
`9:16:42AM
`9:16:49AM
`
`23 afford to pay for them.
`24
`«=©Q. Are you aware of payments that
`25 Regeneron made to the Chronic Disease Fund or
`
`9:16:58AM
`9:1 700AM
`9:17:02AM
`
`www.veritext.com
`
`Veritext Legal Solutions
`
`3 (Pages 6 - 9)
`
`888-391-3376
`
`
`
`Case 1:22-cv-00061-TSK-JPM Document 624 Filed 09/01/23 Page 5 of 56 PageID #: 48182
`Cased 222v200005-TSKHANM Docamenh6222 PiethIS0HR3 Page SOP5&Pagali= & 40182
`PagelD #: 29033
`
`1
`
`the founclation that operates it?
`
`9:17:06AM
`
`1 the lawsuits, but ] don't know if that was
`
`Page 10
`
`Page 12
`9:20:094M
`
`S1708AM
`MR. BERL: Objection.
`2
`9:17:15AM
`I['mnot personally aware of
`<A.
`3.
`9:17:16AM
`4 payments. That is not my side of the business.
`9:1722AM
`3 I believe that we provide donationsto that
`6 foundation.
`9:17:254M
`
`9:20:12AM
`2 involved in his leaving from the company.
`9:20:16AM
`3
`Q. Doyou have an understanding that
`4 Murray Goldberg was involved with some of these
`9:20: 18AM
`5 foundation issues?
`9:20:20AM
`
`6
`
`A.
`
`[denot.
`
`9:20:224AM
`
`7 Q How about your CEO Len Schleifer?
`8 A Idonot.
`9:20:284M
`
`9:20:23AM
`
`9:17:30AM
`Q Doayou know the size and scope of
`7
`97:33AM
`8 the donations that Regeneron has provided to
`9 that foundation?
`9:17:35AM
`
`10
`
`A. No, Ido not.
`
`9:17:37AM
`
`Q. Do you know why Regeneron made
`Il
`12 donations to that foundation?
`
`17:38AM
`9:17:39AM
`
`A. My understandingis so that the
`130
`14 foundation can help pay the co-payments for
`15 patients below a certain poverty level who
`16 cannot afford io pay for the co-payments for
`17 those medicines themselves.
`
`9:17:44AM
`9:17;47AM
`9:17:53AM
`9:117:574AM
`9:18:00AM
`
`Q Can you state your educational
`9
`10 background post high school?
`11
`«6A
`[received an undergraduate degree
`12 from Columbia College.
`I] received medical and
`13 Ph.D. degrees from Columbia as well.
`14.
`Q. Howisit that you cameto be
`15 involved with Regeneron around the 1989 time
`16 period J think?
`9:21:01AM
`i?
`A.
`I was approached by Leonard
`9:21°04AM
`18==Q. Do you have an understanding that 9:18:05AM 18 Schleifer who had interacted with my Ph.D. 9:21:10AM
`
`
`
`19 Regeneron spent tens of millions of dollars in
`9:18:06AM
`19 mentor about the possibility of helping start
`9:21:16AM
`20 grants to that foundation?
`9:18:11AM
`20 this new company.
`9:21:23AM
`21.)
`A.
`[really do not know the amounts
`18:13AM
`21
`Q Who was your Ph.D. mentor?
`9:21:24AM
`22
`«A. Fred Alt.
`9:21:29AM
`22 that we have donated to that foundation.
`9:18:17AM
`
`9:20:30AM
`9:20:31AM
`9:20;39AM
`9:20:41AM
`9:20:49AM
`9:20:54AM
`9:20:57AM
`
`«Q.) Whoarethe individuals you most
`2300
`24 closely associate with Regeneron as
`25 understanding Regeneron's interaction with the
`
`9:18:20AM
`9:18:22AM
`9:18:24AM
`
`«Q.
`23°
`24 thesis?
`
`«~What was the subject of your Ph.D.
`9:21:34AM
`
`9:21:30AM
`
`25
`
`<A. The molecular biology of lymphocyte
`
`9:21:454AM
`
`1 Chronic Disease Fund and the foundation that
`
`Page 11
`9:18:30AM
`
`2 operates it?
`3.
`A. Well, 1 would -- 0 1 believe the
`
`4 case that you are referring to is referring ta
`5 issues back in 2013.
`I do not know who at
`
`$:18:33AM
`9:18:354M
`9:18:43AM
`9:18:46AM
`
`9:18:54AM
`6 Regeneron waslargely responsible for
`$:19:00AM
`7 interactions.
`J assume it would be somebody in
`9:19:04AM
`9:19:06AM
`9:19: 1OAM
`9:19:12AM
`
`8 our commercial group.
`9
`Q. Like Robert Terifay?
`1 A.
`Idonot know.
`
`$When was the last time you spoke
`=@.
`11
`12 with Robert Terifay?
`13°
`A.
`[don't know,
`
`Q. Are you aware ofthe reasons why
`14.
`15 Mr. Terifay left the company?
`168A
`
`$:19;13AM
`9:19:22AM
`9:19:24AM
`9:19: 26AM
`9:19:32AM
`
`1 cell development.
`2 Q What about your educational and
`
`9:21:49AM
`
`9:21:52AM
`
`Page 13
`
`9:21:56AM
`3 Ph.D. work caused Mr. Schleifer to think you
`9:22:03AM
`4 would be a goadfit for what he was trying to
`9:22:05AM
`5 do with Regeneron?
`9:22:06AM
`6
`MR. BERL: Objection.
`7
`&. Atthe time the field of cloning
`
`9:22; 10AM
`9:22:25AM
`9:22:36
`9:22:40AM
`9:22:46AM
`
`8 genes was in its infancy and the idea was that
`9 would be a major component of what the company
`10 would be trying to do, particularly clone nerve
`i] growth factors that control nerve growth and
`12 could be used to fight back against
`
`I am aware of someofthe reasons.
`
`13 neuradegenerative diseases and to that point in
`14 time there bad anly been a single nerve growth
`15 factor identified and the dream wasto try to
`16 clone many more and then use them to help
`17 ¢ither grow or sustain neurons that were dying
`
`9:22:54AM
`9:22:57AM
`9:23:04AM
`9:23:07AM
`9:23:15AM
`
`9;23:224M
`9:19:34AM
`«6. What are some of the reasons you're
`17)
`9:23:27AM
`18 aware of?
`9:19:36AM
`18 in neurodegenerative diseases.
`9:23:31AM
`
`19=A. [know that he had a number of 9:19:40AM
`
`19
`Tn order to do that, one would have
`9:23:33AM
`9:23:37AM
`
`20 catastrophic medical events such as multiple
`21 strokes that affected his ability to come to
`22 work.
`9:19:544M
`
`9:19:42AM
`9:19:48AM
`
`20 to bring gene cloningin a big way into the
`21 field of neurobiology. There were not that
`22 many gene cloners and there were not that many
`
`9:19:3534M
`«Q. Any others you're aware of?
`23.
`9:19:59AM
`A.
`[know that he was tangentially or
`24
`25 somehow involved with the foundation issues and
`9:20:06AM
`
`23 gene cloners in that field. Most of them were
`24 in immunology, which is where I had been, and
`25 his idea or plan was to bring somebody from a
`
`9:23:41AM
`9:23:444AM
`9:23:48AM
`9:23:56AM
`
`www.veritext.com
`
`Veritext Legal Solutions
`
`4 (Pages 10 - 13)
`
`888-391-3376
`
`
`
`Case 1:22-cv-00061-TSK-JPM Document 624 Filed 09/01/23 Page 6 of 56 PageID #: 48183
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`Page 16
`Page 14
`9:27:27AM
`@Q And they eventually wound up using I
`1
`24:01AM
`1 different field, but [ had had a longstanding
`9:24:05AM
`2 interest for various reasons inte
`
`2 believe MacugenIbelieve initially in some of 9:27:30AM
`3 their clinical work?
`9:27:33AM
`3 neurodegenerative diseases and so it was a very
`9:24:09AM
`4 A Na,
`9:27:35AM
`4 naturalfit that J, as a gene cloner, would
`9:24:144AM
`5 moveto this new company that was going to try
`9:24:17AM
`& to use gene cloning as a way to fighi back
`9:24:20AM
`7 against neuradegenerative diseases.
`9:24:26AM
`8
`Q. Before you get to Regeneron, did you
`9:24:29AM
`> have any training in the field of
`9:24:31AM
`10 ophthalmology?
`9:24:33AM
`11
`=A. During medical training you do
`9:24:46AM
`12 required rotations in the various areas,
`9:24:50AM
`13 including ophthalmolagy.
`9:24:564M
`14.
`Q. About how much time do you think you
`9:24:58AM
`15 spent doing the rotation in ophthalmology when
`9:25:01AM
`16 you were in med school?
`9:25;04AM
`17
`=A.
`[don't remember exactly.
`9:25:07AM
`
`
`
`
`18=Q. More than six months? 9:25:08AM 18 Q. Who was that in collaboration with? 9:28:17AM
`19°)
`A. That was in — I'm not --
`9:28:20AM
`
`9:27:40AM
`Q. Well, what molecules were they
`5
`9:27:43.4M
`& injecting into the eye?
`7
`MR. BERLE: Objection. Vague as to
`9:27:45AM
`8
`time.
`9:27:46AM
`
`9:27:51AM
`A. Lecontacted them about injecting
`9
`9:27:56AM
`10 BDNF neurotrophin 3 and ciliary neurotrophic
`9:28:02AM
`11 factors and those were the factors they were
`12 injecting into the eye.
`9:28:04AM
`13.
`Q. Now,the initial neuradegenerative
`9:28:06AM
`14 product that Regenerontried ta bring to market
`9:28:09AM
`15 that went to Phase [I] trials, it never got to
`9:28:12AM
`16 market, righi?
`9:28: 13AM
`17) A Thatis correct.
`9:28:16AM
`
`9:25:10AM
`=A. Probably noi.
`19)
`20
`4. Sanofi?
`9:23:37AM
`
`202=6©Q. Whattraining did you acquire while 9:25:12AM
`21
`=A.
`Ji wasn't Sanofi. What I'ma
`9:28:38AM
`21 you were at Regeneron in the field of
`9:25; 13AM
`22 ophthalmology or diseases involving
`9:25:20AM
`23 ophthalmology?
`9:25:23AM
`24
`MR. BERL: Objection. Vague.
`9:25:24AM
`25
`A. When helped lead our efforts to
`9:25:33AM
`
`22 struggling with is we had multiple things of
`23 neuradegenerative diseases, multiple of which
`24 we put into Phase ID] trials which didn't
`25 succeed and I] don't know which wasthefirst.
`
`9:28:40AM
`9:28:43AM
`9:28:47AM
`9:28:48AM
`
`Page 15
`Page 17
`9:25:40AM
`1 I can't remember which was the first one ta
`9:28:50AM
`1 cloneavariety of nerve growth factors,I
`o:25;47AM
`2 have failed. Some of whom -- some of these we
`9:28;32AM
`2 realized that there were also essentially the
`9:235:53AM
`9:28:56AM
`9:29:00AM
`9:29:03AM
`9:29:07AM
`
`3 brought forth with partners and some of which
`4 we brought forth by ourselves.
`5
`Q. When did Regeneron start making the
`6 switch or adding the focus on ophthalmology in
`7 developing molecules for ophthalmic uses?
`8
`<A. AsI said, we first started
`
`9:29:12AM
`9:29:294M
`9:29:33AM
`9:29:38AM
`9:29:44AM
`
`9 exploring this possibility with LaVail and
`10 Steinberg in the early 1990s.
`il
`Q. When wasthefirst time -- well, did
`12 anything come of those initial efforts with Dr.
`
`13 Steinberg and others involving the — I think
`14 you called it BDNF and other neurotrapic
`15 factors?
`9:30:03AM
`
`9:29;47AM
`9:29:52AM
`9:29:574AM
`
`i6
`17)
`
`MR. BERL: Objection.
`A) Webuilt internal expertise and
`
`9:30:04AM
`9:30:06AM
`
`18 knowledge and created a group among several
`19 other groups that we had that studied the eye
`20 and eye diseases and generated a lot of
`21 upiise and knowledge.
`22
`Q. Who were those intemal experts that
`
`9:30:134M
`9:30: LEAM
`9:30:23AM
`9:3028AM
`$:30;29AM
`
`23 you had at Regeneron relating to the ophthalmic
`24 field?
`9:30:38AM
`
`9:30:32AM
`
`25
`
`A.
`
`Itdepends on your definition of
`
`9:30:444M
`
`9:27:24AM
`
`3 equivalent of neurodegenerative diseases of the
`4 eye.
`9:25:57AM
`
`9:26:00AM
`So just retinal deterioration
`5
`6 degenerative conditions and so forth. So I had
`9:26:03AM
`7 the idea thai perhaps we could just like we
`9:26:03AM
`
`8 were trying to help neurons that were dying in
`% neuradegenerative diseases in the brain, such
`10 as an Alzheimer's disease or in the spinal
`11 cord, such as in Lou Gehrig's disease, that we
`12 could also maybe use nerve growth factors to
`
`13 help the neurons in the eye survive in retinal
`14 degeneration diseases as the retina is an
`15 outcropping of the brain.
`16
`Sa I contacted at the time some
`
`17 scientists who | felt were leaders in this
`
`9:26: 13AM
`9:26:174AM
`9:26:20AM
`9:26:23AM
`9:26:30AM
`9:26:33AM
`9:26:39AM
`9:26:43AM
`9:26:47AM
`
`$:26;53AM
`9:26:59AM
`9:27:02AM
`9:2708AM
`9:27:12AM
`
`18 field and ] suggested that we work together to
`19 inject nerve growth factors into the eye,
`20 starting with animal models to try to protect
`21 them against these models of neurodegenerative
`22 disease.
`9:27: 18AM
`
`Q. Those individuals you imitially
`23.
`24 contacted, who were they?
`25
`A. Math LaVail and Roy Steinberg.
`
`9:27:19AM
`9:27:21AM
`
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`Case 1:22-cv-00061-TSK-JPM Document 624 Filed 09/01/23 Page 7 of 56 PageID #: 48184
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`93:46AM
`1 experts.
`2
`Q. The way in which you just used the
`3 term, what you referred to as your internal
`4 expertise, the people involved in building that
`5 internal expertise and knowledge you referred
`6 to?
`9:30:574M
`
`9:30:48AM
`9:30:50AM
`9:30:52AM
`9:30:554M
`
`9:30:58AM
`I would say it would be primarily
`<A.
`7
`8 myself and an individual known as Stan Wiegand.
`9:30:594M
`9 @ Well, you didn't have any formal
`9:31: LIAM
`10 training in eye diseases. Did Stan Wiegand
`9:31:12AM
`11 have any training in eye diseases?
`31:16AM
`12
`MR. BERL: Objection. Lack of
`9:31: 18AM
`13.
`foundation.
`9:31:19AM
`
`14
`
`A Instience I'm not sure what formal
`
`9:3 1:28AM
`
`15 training really means.
`16)
`«6. Well, you didn't — I mean IJ think
`17 you said that your experience before you
`18 started working on these projects was limited
`19 to # rotation during medical school. So you
`20 never worked as an ophthalmologist, never did a
`21 residency in aphthabuology, didn't have a
`22 post-doc or a fellowship on ophthalmology,
`23 never treated patients, might?
`24
`MR. BERL: Objection. Compound.
`25
`Q. Was Mr. Wiegand somebody who had
`
`9:31:33AM
`9:31:37AM
`9:31:39AM
`9:31:42AM
`9:31:45AM
`9:31:47AM
`9:31:52AM
`9:31:55AM
`9:31:59AM
`9:32:01AM
`9:32:;04AM
`
`] ophthalmologist or treated patients with eye
`2 diseases?
`9:334:03AM
`
`Page 20
`9:33:384M
`
`MR. BERL: Objection. Vagueas to
`9:34:06AM
`times.
`9:34: LOAM
`
`9:34:04AM
`
`QQ. Say prior 2005.
`A.
`[don't know.
`
`9:34:21AM
`9:34:27AM
`
`3
`4
`
`5
`6
`
`7
`8g
`9
`
`Q When, in what time period was it
`9:34:304AM
`decided to test the VEGF compoundin the eye?
`9:34:48AM
`A.
`I don't rememberexactly.
`9:34:504M
`Q. Well, was VEGFtried first for
`10
`4] cancer and then it led into the eye or the eye
`12 camefirst and that led into the cancer
`13 indications?
`
`9:34:544M
`9:34:57AM
`9:35:00AM
`9:35:02AM
`9:35:174M
`
`i4
`15.
`
`A.
`
`MR. BERLE: Objection. Vague.
`It's hard ta remember.
`I think that
`
`ié Imay have been thinking of them somewhat
`i7 simultaneously. Maybe cancer first. Hard to
`18 remember.
`9:35:37AM
`
`9:33:20AM
`9:35:31AM
`
`9:35:444M
`Isit fair to say that Regeneron has
`Q.
`19
`9:35:46AM
`20 been at the center of your professional career
`21 for the last 30 years?
`9:35,49AM
`22
`=A.
`Its been my entire career for the
`9:35:56AM
`23 last 30 plus ae
`9:361AM
`i11
`' Regeneron Protected Material |
`1-
`
`hiEEmm
`
`1 that kind of experience?
`2
`MR. BERL: Objection. Vague,
`
`compound.
`3
`<A.
`Ph.D. training,sciencetraining is
`4
`5 largely learning by doing and asking and
`6 exploring questions that have not been asked
`7 before and that's how one learns and that is
`
`8 arguably how most ofus, including me, as
`% scientists have gotten mast of your training,
`10 including in eye diseases or in allergic
`11 diseases or in inflammatory diseases or in
`12 couscular diseases. That's where most of the
`
`9:32:06AM
`
`Page 19 |
`
`9:32:07AM
`9:32:08AM
`9:32: 13AM
`9:32:16AM
`9:32:22AM
`
`9:32:26AM
`9:32:334AM
`9:32:394M
`9:32:42AM
`
`9:32:49AM
`9:32:554AM
`
`Fro not sure. Regeneron Protected Material
`
`9:33:02AM
`13 training happens.
`14.
`@. When did you bring Jesse Cedarbaum
`9:33:06AM
`15 on board?
`9:33:08AM
`
`16
`17
`
`Jsthat when or why?
`MR. BERL:
`M8. MAZZOCHI: When.
`
`9:33: IGAM
`9:33:124M
`
`A.
`18
`19 board.
`20
`21
`
`22
`23
`
`Idid not bring Jesse Cedarbaum on
`9:33:18AM
`9:33:194M
`9:33:24AM
`
`Who did?
`I don't know for sure.
`
`9:33: 14AM
`
`Who brought Avner Ingerman. on board?
`9:33:37AM
`9:33:52AM
`
`9:33:29AM
`
`Did Regeneron ever have anyone on
`24
`25 staffwho had actually worked as an
`
`9:33:55AM
`
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`Case 1:22-cv-00061-TSK-JPM Document 624 Filed 09/01/23 Page 8 of 56 PageID #: 48185
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`Pape
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`22
`
`! Regeneron Protected Material
`
`epeermrm eei aaIYees
`
`
`
`age2Locafobstenchal
`
`Page 24
`
`1 indications?
`
`2
`
`A. No, I was not.
`
`9:40:084M
`
`9:40: 10AM
`
`9:40:13AM
`Q. Did you play anyrole in trying to
`3
`9:40:16AM
`4 make sure that you were keeping US revenues
`9:40: L9AM
`5 from aflibercept at Regeneron and not in the
`6 hands of partners?
`9:40:23AM
`7 A I wasn't involved in those parts of
`9:40:31AM
`8 the negotiations.
`9:40:34AM
`9
`Q Do you remember urging Len Schleifer
`10 that be should ensure that Regeneron was going
`i] to keep a hundred percent of the US revenues
`i2 from aflibercept in connection with the Bayer
`13 deal?
`9:40:534M
`
`9:40:35AM
`9:40:39AM
`9:40:43AM
`9:40:46AM
`
`[donot remember doing that.
`A.
`14.
`Im goingto place before you
`Q.
`i150
`14 documents that were previously marked as
`17 Defendant's Exhibit 4 and Defendant's
`
`9:40:53AM
`9:40:57AM
`9:40:594M
`9:41:01AM
`
`18 Exhibit 5, the '601 and '57?2 patents in this
`19 case.
`9:41:11AM
`
`9:41:03AM
`
`Q. Would it be fair to say that the
`6
`7 bulk of payers for the aflibercept in some way,
`8 shape or form are state and federal
`9 governments?
`10
`«=A. Can you say that again?
`11 Q Sure. Wouldit be fair to say that
`12 the largest number ofdollars in sales for
`13 aflibercept come in some way, shape or form
`14 through state and federal governments such as
`15 Medicaid and Medicare programs?
`16
`MR. BERL: Objection.
`=A.
`17.
`‘I'm primarily in charge of the
`18 science.
`I dan't know that much believe it or
`
`9:37:424M
`9:37:43AM
`9:37:49AM
`9:37:52AM
`9:37:564AM
`9:37:38AM
`9:37:59AM
`9:38:04AM
`9:38:07AM
`9:38:10AM
`9:38: 13AM
`9:38:22AM
`9:38:23AM
`
`19 not about those numbers.
`
`I believeit’s true
`
`9:38:26AM
`
`9:38:314AM
`20 that Medicare does pay for a Lot of the use of
`9:38:39AM
`21 BYLEAin elderly patients.
`9:38:41AM
`22
`@. Billions of dollars over the years,
`23 right?
`9:38:434M
`24
`=A.
`[knowthat it’s a lot of money,
`9:38:44AM
`25 yes.
`9:38:46AM
`
`$:41:15AM
`Feel free to read the whole thing,
`20
`2) but if you can confirm that you have seen these
`9:41: 16AM
`22 documents before?
`9:41:19AM
`
`(Witness reviewing document.)
`«A.
`23°
`Q. Dr. Yancopoulos,it's taking you
`24
`25 quite a while to go through these two patents,
`
`9:41:20AM
`9:55:30AM
`9:55:32AM
`
`So your personal wealth has
`Q.
`1
`2 certainly grown significantly as a consequence
`
`Page 23
`9:38:47AM
`9;33:504AM
`
`1 the '601 and 572 patents. Have you not seen
`2 these before?
`9:35:38AM
`
`Page 25
`9:55:34AM
`
`3 of the taxpayer dollars that have been used to
`4 fund Medicaid and Medicare purchases of
`5 aflibercept?
`9:38:39AM
`6
`MR. BERL: Objection.
`9:39:00AM
`7
`I don't think of it that way.
`9:39:08AM
`A.
`8
`9. Ebelieve when it comes to worldwide
`9:39: 16AM
`
`9:38:53AM
`$:38:56AM
`
`% sales of aflibercept, Regeneron bas gotten half
`10 of those through its partnership with Bayer, is
`11 that fair?
`9:39:26AM
`
`9:39:20AM
`9:39:24AM
`
`12
`13.
`
`MR. BERL: Objection.
`[don't know the exact fraction.
`
`A.
`
`9:39:29AM
`9:39:29AM
`
`Q. Were you aneof the individuals who
`14.
`15 were involved in negotiating that deal to
`16 insist that Regeneron would keep a hundred
`17 percent of the US revenuesfor itself for
`
`9:39:32AM
`9:39:33AM
`9:39:36AM
`$:39;39AM
`
`9:39:42AM
`18 aflibercepi?
`9:39:474M
`19)
`A. Which — whatis the question
`9:39:494M
`20 exactly?
`21
`Q. Whenit comes to the Regeneron
`22 apreements with Bayer, were you one ofthe
`
`9:39:50AM
`9:39:344AM
`
`3
`4
`5
`
`6
`7
`8
`
`MR. BERL: Objection. You said feel
`free to read through the whole thing.
`MS. MAZZOCHI: Ifhe needs to
`
`9:55:39AM
`9:55:41AM
`9:55:43AM
`
`9:55:44AM
`identify it.
`MR. BERL: That's not what you said.
`<A. Well, I haven't looked at these in
`
`9:55:45AM
`9:55:47AM
`
`9 detail in a very long time and I was, as you
`10 suggested, I was reviewing the documents. I
`i] have only gotten through one of them right now.
`12
`Q. Well, the specification is the same
`13 for both of them, so no need to read it twice.
`
`9:55:49AM
`9:55:53AM
`9:55:55AM
`$:35:58AM
`9:56:00AM
`
`14 Do you recognize these documents as your
`15 patents?
`9:56:06AM
`16
`A. They look very similar to what I
`9:56:07AM
`17 believe were my patents.
`9:56:08AM
`18
`Q. When was thelast time you actually
`9:56:10AM
`
`9:56:04AM
`
`19 looked at the '601 or '572 patents that you
`20 recall?
`9:56: 154M
`
`9:56:12AM
`
`A Ihave looked at copies of them as
`21
`22 recently as yesterday, but [ haven't reviewed
`
`9:56: 17AM
`9:36: 19AM
`
`23 individuals who imsisted on Regeneron keeping a
`24 hundred percent of the revenues from the US
`25 market for aflibercept for the ophthalmic
`
`9:39:57AM
`9:40:01AM
`9:40:03AM
`
`23 them carefully in years.
`24
`=Q. Do you zecall why you decided to
`25 file for these patents?
`
`9:56:22AM
`9:56:29AM
`9:56:;31AM
`
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`
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`
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`Case 1:22-cv-00061-TSK-JPM Document 624 Filed 09/01/23 Page 9 of 56 PageID #: 48186
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`1
`2
`
`MR BERL: Objection. Vague.
`[don't recall.
`
`A.
`
`Page 26
`9:56:35AM
`9:56:55AM
`
`9:56:58AM
`Ifyou take a look at the second
`Q.
`3.
`9:57:01AM
`4 page of these exhibits, there is a reference to
`9:57:07AM
`5 related US application data and about
`9:57:14AM
`6 two-thirds of the way down to the left-hand
`9:57:16AM
`7 column there is references to provisional
`9:57: 18AM
`8 application number 61/432245 filed on
`57:23AM
`9 January 13, 2011. Do you see that?
`9:57:294AM
`10
`=A. Which patent am I looking at?
`9:37;32AM
`11
`=Itdoesn't matter. Either the '601
`12. or the '572.
`9:57:344AM
`
`10:00:484AM
`1 trial?
`2
`A. The standard dose escalation Phase I
`
`3 trial, ] don't remember who designed this.
`4
`QQ.
`Further down in column 8 there isa
`
`10:01:56AM
`
`10:01:594M
`10:62:03AM
`
`Page 28
`
`10:02:054M
`5 reference to "Example 2" a "PhaseII clinical
`19:02008AM
`& trial of repeated doses of intravitreally
`10:02:13AM
`7 administered VEGF Receptor-based chimeric
`10:02:19AM
`8 molecule (VEGFT)in subjects with neovascular
`16:02:22AM
`9 AMD." [ believe that was the CLEAR-IT 2 study.
`10 Who designed that clinical trial?
`10:02:27AM
`11)
`=A
`sO was involvedin designing that
`10;02:42AM
`12 trial along with my team.
`10:02:43AM
`13°
`Q. Who else on the team?
`10:02:45AM
`
`9:57:37AM
`A. And wherein the patent am I
`13.
`16:02:51AM
`14. A sIt’s so long ago I can't remember.
`9:57:39AM
`14 looking?
`10:02:53AM
`1S.
`Q. Do you know why any of your other
`15.
`Q.
`Second pageof the exhibit. There
`9:57:39AM
`10502:;36AM
`16 team members are not listed on this patent if
`16 you go. Left-hand column about two-thirds of
`$:37:44AM
`10:02:58AM
`17 they helped you with the clinical trial design
`17 the way down, do you see a reference to
`9:57:47AM
`19:03:01AM
`18 or coming up with ideas for the clinical trial
`18 provisional application nurober 61/432245 held
`9:57:50AM
`19 on January 13, 20117
`O:57:55AM
`19 design?
`10:03:04AM
`20
`MR. BERL: Objection. Lack of
`10:03:05AM
`2002
`=A. Could you just repeat the number?
`9:57:59AM
`
`21=foundation. 10:03 :06AM
`219
`Q. 68432245.
`9:3801AM
`22
`A. Yes.
`9:58:054AM
`
`Q. Now,by the time we had reached
`23°
`24 January 13, 2011, would you have considered
`25 yourself to be an ophthalmologist with
`
`9:58:07AM
`9:58: L1AM
`9:58:154AM
`
`=A. This was an exploratory study that
`22
`23 was used to produce data to inform so as to how
`24 to design a dosing regimen and I gather that
`25 the lawyers didn’t think that there was
`
`10:03:44AM
`10:03:47AM
`10:04:;01AM
`10:04:17AM
`
`ed
`
`16:00:464M
`
`_ experience in treating angiogenic eye
`disorders?
`
`9:58:19AM
`9:58:23AM
`
`1 anything inventive here in terms ofusing this
`2 to design the ultimate dosing regimen.
`
`10:04:19AM
`10:04:244M
`
`Page 29
`
`9:58:364M
`A I was never an ophthalmologist.
`9:58-47AM
`Q. Do you have an understanding as to
`9:58:494AM
`why you are listed as the sole named inventor
`on these two patents?
`9:58:52AM
`4. Our legal team would have reviewed
`9.59°22AM
`all the work andeffort that is described
`9:59-27AM
`herein and reached that conclusion.
`9:59;324M
`
`Q. Well, let's take a look, for
`example, int DX4, the '601 patent andlet’s
`start with columm 8, example.
`Onethere is a reference to a "Phase
`
`9:59:40AM
`9:59:424AM
`9:59;55AM
`10:00:03AM
`
`10:00:05AM
`1 Clinical Trial of Intravitreally Administered.
`VEGF Receptor-Based Chimertc Molecule VEGFT in
`10:00:124M
`Subjects with Neovascular AMD.” That's in
`10:00:'2LAM
`colunn 8. Let me know when you are there,
`10-00;25AM
`A In patent 6017
`16:00:28AM
`Yes.
`10:00:30.AM
`
`10:04:26AM
`Q Takes look at "Example 3: Phase I
`3.
`10;04:29AM
`4 Choial Tnal of Systemucally Administered.
`5 VEGF Receptor-Based Chimeric Molecule (VEGFT)
`10:04:34.4M
`6 in Subjects with neovascular AMD." Did you
`10:04:40AM
`7 have any role in designing this clinical trial?
`10-:04;43AM
`
`10:05:57AM
`A Timsure I played a role in the
`10:05:.594M
`design of this, but [ can't remember the
`details.
`10:06:00AM
`
`Q Do you kitow if you were ever
`identified as a coauthor on any publication
`
`10:06:01AM
`10:06:024M
`
`describing this clinical trial?
`A.
`I couldn't remember.
`
`10:06:06AM
`10:06:12AM
`
`10:06:14.4M
`Q Do you recall whether this trial was
`one that was done with Dr. Cedarbaum and others
`10:06: 15.AM
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`10:06:20AM
`at Johns Hopkins?
`A I wouldbelieve that Dr. Cedarbaum
`16:06:26AM
`was involved. I'm not sure with which sites ke
`10:06:28AM
`
`10:00:31.4M
`T see page numbers.
`. Yes, go to column 8. Q.=Let's take 4 look at Example 4 which10:00:324M 10:06:33AM
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`
`
`is titled "Phase IClinical Trials ofthe
`10:06:35AM
`Page 8?
`10:00:354M
`No, column 8.
`10:00:364M
`Isee. Yes.
`10:00:394AM
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`20 collaborated.
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`10:06:31AM
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`Efficacy, Safety, and Tolerability of Repeated
`24 Doses of Intravitreal VEGFTin Subjects with
`25 Neovascular Age-Related Macular Degeneration."
`
`10:06:39AM
`10:06:44AM
`10:06:50AM
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`. Who designed that PhaseI clinical
`
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