1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
` UNITED STATES PATENT AND TRADEMARK OFFICE
`
`Page 1
`
` --oOo--
`
`MYLAN PHARMACEUTICALS, INC.,
`
`CELLTRION, INC., and
`
`APOTEX, INC.,
`
` Petitioners,
`
`vs. CASE NO.
`
` IPR2021-00881
`
`REGENERON PHARMACEUTICALS, INC., Patent No.
`
` 9,254,338 B2
`
` Patent Owner.
`
`_________________________________/
`
` VIDEO-RECORDED DEPOSITION OF DIANA V. DO, M.D.
`
` PALO ALTO, CALIFORNIA
`
` THURSDAY, APRIL 21, 2022
`
`Reported by:
`
`Anrae Wimberley, CSR No. 7778
`
`Job No. 5149529
`
`www.veritext.com
`
`888-391-3376
`
`Veritext Legal Solutions
`
`Mylan Exhibit 1109
`Mylan v. Regeneron, IPR2021-00880
`Page 1
`
`
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
` UNITED STATES PATENT AND TRADEMARK OFFICE
`
`Page 1
`
` --oOo--
`
`MYLAN PHARMACEUTICALS, INC.,
`
`CELLTRION, INC., and
`
`APOTEX, INC.,
`
` Petitioners,
`
`vs. CASE NO.
`
` IPR2021-00881
`
`REGENERON PHARMACEUTICALS, INC., Patent No.
`
` 9,254,338 B2
`
` Patent Owner.
`
`_________________________________/
`
` VIDEO-RECORDED DEPOSITION OF DIANA V. DO, M.D.
`
` PALO ALTO, CALIFORNIA
`
` THURSDAY, APRIL 21, 2022
`
`Reported by:
`
`Anrae Wimberley, CSR No. 7778
`
`Job No. 5149529
`
`www.veritext.com
`
`888-391-3376
`
`Veritext Legal Solutions
`
`Mylan Exhibit 1109
`Mylan v. Regeneron, IPR2021-00880
`Page 1
`
`
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
` UNITED STATES PATENT AND TRADEMARK OFFICE
`
`Page 2
`
` --oOo--
`
`MYLAN PHARMACEUTICALS, INC.,
`
`CELLTRION, INC., and
`
`APOTEX, INC.,
`
` Petitioners,
`
`vs. CASE NO.
`
` IPR2021-00881
`
`REGENERON PHARMACEUTICALS, INC., Patent No.
`
` 9,254,338 B2
`
` Patent Owner.
`
`__________________________________/
`
` Transcript of video-recorded deposition
`
`of DIANA V. DO, M.D., taken at Arnold & Porter LLP
`
`located at 3000 El Camino Real, Suite 500, Five Palo
`
`Alto Square, Palo Alto, California 94306, beginning
`
`at 9:10 a.m. and ending at 5:10 p.m. on THURSDAY,
`
`APRIL 21, 2022, before Anrae Wimberley, Certified
`
`Shorthand Reporter No. 7778.
`
`www.veritext.com
`
`888-391-3376
`
`Veritext Legal Solutions
`
`Mylan Exhibit 1109
`Mylan v. Regeneron, IPR2021-00880
`Page 2
`
`
`
`Page 3
`
`A P P E A R A N C E S :
`
`F O R T H E P E T I T I O N E R S :
`
` R A K O C Z Y M O L I N O M A Z Z O C H I S I W I K
`
` B Y : H E I N Z J . S A L M E N , E S Q .
`
` S C O T T B E A L L , P h . D . , E S Q .
`
` S i x W e s t H u b b a r d S t r e e t
`
` C h i c a g o , I l l i n o i s 6 0 6 5 4
`
` ( 3 1 2 ) 5 2 7 - 2 1 5 7
`
` h s a l m e n @ r m m s l e g a l . c o m
`
` s b e a l l @ r m m s l e g a l . c o m
`
`F O R T H E P A T E N T O W N E R :
`
` A R N O L D & P O R T E R
`
` B Y : D E B O R A H F I S H M A N , E S Q .
`
` F i v e P a l o A l t o S q u a r e
`
` 3 0 0 0 E l C a m i n o R e a l , S u i t e 5 0 0
`
` P a l o A l t o , C a l i f o r n i a 9 4 3 0 6
`
` ( 6 5 0 ) 3 1 9 - 4 5 0 0
`
` d e b o r a h . f i s h m a n @ a r n o l d p o r t e r . c o m
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`1 0
`
`1 1
`
`1 2
`
`1 3
`
`1 4
`
`1 5
`
`1 6
`
`1 7
`
`1 8
`
`1 9
`
`2 0
`
`2 1
`
`2 2
`
`2 3
`
`2 4
`
`2 5
`
`www.veritext.com
`
`888-391-3376
`
`Veritext Legal Solutions
`
`Mylan Exhibit 1109
`Mylan v. Regeneron, IPR2021-00880
`Page 3
`
`
`
`Page 4
`
`ALSO PRESENT:
`
` EILEEN WOO, with Regeneron Pharmaceuticals
`
` PETRA SCAMBOROVA, with Regeneron
`
` Pharmaceuticals
`
` VINNY LEE, In-House Counsel for Viatris on
`
` behalf of Petitioner Mylan Pharmaceuticals
`
` (TELEPHONIC APPEARANCE)
`
` KEIGO PAINTER, VIDEOGRAPHER
`
` VERITEXT LEGAL SOLUTIONS
`
` --oOo--
`
`1
`
`2
`
`3
`
`4
`
`5 6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`www.veritext.com
`
`888-391-3376
`
`Veritext Legal Solutions
`
`Mylan Exhibit 1109
`Mylan v. Regeneron, IPR2021-00880
`Page 4
`
`
`
`Page 5
`
` I N D E X
`EXAMINATION BY: PAGE
`MR. SALMEN 9, 133
` --oOo--
`
` E X H I B I T S
`EXHIBIT DESCRIPTION PAGE
`Exhibit 1 Petitioner's Notice of 9
` Deposition of Diana V. Do,
` M.D.; No Bates numbers, 3
` pages
`
`Exhibit 2 Regeneron press release 56
` dated 11/22/19; No Bates
` numbers, 2 pages
`
`Exhibit 3 Scientific American article 57
` dated 10/6/08; No Bates
` numbers, 4 pages
`
`Exhibit 4 Claim 1 recreated document; 147
` No Bates numbers, 1 page
`
` --oOo--
`
`1
`2
`3
`4
`
`5 6
`
`7
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`www.veritext.com
`
`888-391-3376
`
`Veritext Legal Solutions
`
`Mylan Exhibit 1109
`Mylan v. Regeneron, IPR2021-00880
`Page 5
`
`
`
`Page 6
`
` E X H I B I T S P R E V I O U S L Y M A R K E D
`EXHIBIT DESCRIPTION PAGE
`Exhibit 1001 U.S. Patent No. 9,254,338; 53
` No Bates numbers, 14 pages
`
`Exhibit 1024 Application for Extension 51
` of Patent Term re '758
` patent; No Bates numbers,
` 198 pages
`Exhibit 1035 Lalwani article; No Bates 180
` numbers, 17 pages
`
`Exhibit 1074 Ciulla/Rosenfeld article; 177
` No Bates numbers, 8 pages
`Exhibit 2002 Curriculum Vitae; No Bates 198
` numbers; 40 pages
`
`Exhibit 2051 Declaration of Diana V. Do, 12
` M.D.; No Bates numbers, 67
` pages
`
`Exhibit 2093 Margolis article; No Bates 190
` numbers, 4 pages
`Exhibit 2122 Study of ranibizumab first 206
` posted 1/17/13; No Bates
` numbers, 12 pages
`Exhibit 2123 Study of ranibizumab first 207
` posted 1/17/13; No Bates
` numbers, 12 pages
`Exhibit 2185 EYLEA prescribing 23
` information; No Bates
` numbers, 15 pages
` --oOo--
`QUESTIONS WITNESS INSTRUCTED NOT TO ANSWER:
` (None.)
` --oOo--
`
`1
`2
`3
`
`4
`
`5
`
`6
`7
`
`8
`
`9
`10
`
`11
`
`12
`
`13
`
`14
`15
`
`16
`17
`
`18
`19
`
`20
`21
`22
`23
`24
`25
`
`www.veritext.com
`
`888-391-3376
`
`Veritext Legal Solutions
`
`Mylan Exhibit 1109
`Mylan v. Regeneron, IPR2021-00880
`Page 6
`
`
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`Page 7
`
` THURSDAY, APRIL 21, 2022;
`
` PALO ALTO, CALIFORNIA;
`
` 9:10 A.M.
`
` - - -
`
` THE VIDEOGRAPHER: Good morning. 09:10:25
`
` We're going on the record at 9:10 a.m. on
`
`April 23rd [sic], 2022.
`
` Please note that the microphones are
`
`sensitive and may pick up whispering, private
`
`conversations and cellular interference. Please 09:10:37
`
`turn off all cell phones or place them away from the
`
`microphones, as they can interfere with the
`
`deposition audio.
`
` Audio and video recording will continue to
`
`take place unless all parties agree to go off the 09:10:46
`
`record.
`
` This is Media Unit 1 of the video-recorded
`
`deposition of Dr. Diana Do taken by the counsel for
`
`petitioner in the matter of Mylan Pharmaceuticals,
`
`Inc., et al., versus Regeneron Pharmaceuticals, Inc. 09:10:56
`
`filed in the United States Patent and Trademark
`
`Office. Case No. IPR2021-00880 [sic].
`
` This deposition is being held at Arnold &
`
`Porter LLP located at 3000 El Camino Real, Suite
`
`500, Five Palo Alto Square, Palo Alto, California 09:11:17
`
`www.veritext.com
`
`888-391-3376
`
`Veritext Legal Solutions
`
`Mylan Exhibit 1109
`Mylan v. Regeneron, IPR2021-00880
`Page 7
`
`
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`94306. 09:11:20
`
`Page 8
`
` My name is Keigo Painter from the firm
`
`Veritext. I'm the videographer. The court reporter
`
`is Anrae Wimberley from the firm Veritext.
`
` I'm not related to any party in this 09:11:28
`
`action, nor am I financially interested in the
`
`outcome.
`
` Counsel and everyone present in the room
`
`and everyone attending remotely will now state their
`
`appearances and affiliations for the record. 09:11:37
`
` If there are any objections to the
`
`proceeding, please state them at the time of your
`
`appearance, beginning with the noticing attorney.
`
` MR. SALMEN: Heinz Salmen of RMMS on behalf of
`
`Petitioner Mylan. 09:11:48
`
` MR. BEALL: Scott Beall, RMMS, on behalf of
`
`petitioner.
`
` MR. SALMEN: With us on the phone is Vinny Lee
`
`of -- in-house counsel at Viatris on behalf of
`
`Petitioner Mylan. 09:12:02
`
` MS. FISHMAN: Deborah Fishman of Arnold &
`
`Porter on behalf of patent owner and representing
`
`the witness. With me today are in-house counsel
`
`from Regeneron, Dr. Petra Scamborova and Eileen Woo.
`
` And then one correction to the record. 09:12:17
`
`www.veritext.com
`
`888-391-3376
`
`Veritext Legal Solutions
`
`Mylan Exhibit 1109
`Mylan v. Regeneron, IPR2021-00880
`Page 8
`
`
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`This deposition is being taken in IPR2021-00881. 09:12:20
`
`Page 9
`
` THE VIDEOGRAPHER: Okay.
`
` Will the court reporter please swear in
`
`the witness.
`
` DIANA V. DO, M.D., 09:12:36
`
` sworn in personally as a witness by the Certified
`
` Shorthand Reporter, testified as follows:
`
` EXAMINATION
`
`BY MR. SALMEN:
`
` Q. Good morning, Dr. Do. 09:12:51
`
` A. Good morning.
`
` Q. I'm going to hand you what's been marked
`
`Do Exhibit No. 1.
`
` MR. SALMEN: Actually, can I keep one of them?
`
` MS. FISHMAN: Of course. 09:13:03
`
` (Deposition Exhibit 0001 was marked.)
`
`BY MR. SALMEN:
`
` Q. Dr. Do, is it your understanding that you
`
`are being deposed today pursuant to this notice and
`
`agreement of the parties in the IPR 09:13:12
`
`Proceeding 2021-00881?
`
` A. Yes, it is.
`
` Q. You understand that there is a second
`
`proceeding as well; correct?
`
` A. Which proceeding is that you're referring 09:13:23
`
`www.veritext.com
`
`888-391-3376
`
`Veritext Legal Solutions
`
`Mylan Exhibit 1109
`Mylan v. Regeneron, IPR2021-00880
`Page 9
`
`
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`to? 09:13:28
`
`Page 10
`
` Q. This proceeding on the face of Do
`
`Exhibit 1 pertains to Patent No. 9,254,338; is that
`
`correct?
`
` A. Yes, it does. 09:13:37
`
` Q. Are you familiar with the '069 patent?
`
` A. I am familiar with it.
`
` Q. You've reviewed the '069 patent?
`
` A. I have not reviewed it recently, but I am
`
`familiar in general with it. 09:13:56
`
` Q. Did you review the prosecution history for
`
`the '069 patent?
`
` A. No, I did not review that.
`
` Q. Did you review Dr. Albini's declaration
`
`with respect to the '069 patent? 09:14:07
`
` A. I read briefly Dr. Albini's deposition.
`
` Q. Okay. So my question was with regard to
`
`Dr. Albini's declaration for the '069 patent.
`
` Did you review that?
`
` A. Yes, I did review that. 09:14:24
`
` Q. Did you review Dr. Albini's deposition
`
`transcript?
`
` A. No. I believe I only reviewed his
`
`declaration.
`
` Q. Okay. Did you review Regeneron's patent 09:14:36
`
`www.veritext.com
`
`888-391-3376
`
`Veritext Legal Solutions
`
`Mylan Exhibit 1109
`Mylan v. Regeneron, IPR2021-00880
`Page 10
`
`
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`owner response with respect to the '069 patent? 09:14:39
`
`Page 11
`
` A. No, I did not.
`
` Q. So as far as you know, your testimony
`
`today is only being applied in support of the '338
`
`patent proceedings that's Case No. IPR 2021-00881? 09:14:52
`
` A. Yes, that is correct.
`
` Q. Do you understand that your declaration --
`
`and I'm going -- strike that.
`
` I'm going to refer to the current
`
`proceeding as "the '338 patent proceeding." 09:15:09
`
` Do you understand what I'm referring to
`
`then?
`
` A. Yes, I do.
`
` Q. Okay. You understand that your
`
`declaration for the '338 patent is your direct 09:15:17
`
`examination in this proceeding?
`
` A. Yes, I do.
`
` Q. And do you understand that the questions
`
`I'm asking you today constitute your
`
`cross-examination in that proceeding? 09:15:29
`
` A. Yes, I do.
`
` Q. Have you ever been cross-examined?
`
` A. No, I have not.
`
` Q. Have you ever been deposed before?
`
` A. Yes, I have. 09:15:42
`
`www.veritext.com
`
`888-391-3376
`
`Veritext Legal Solutions
`
`Mylan Exhibit 1109
`Mylan v. Regeneron, IPR2021-00880
`Page 11
`
`
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
` Q. When was your last deposition? 09:15:44
`
`Page 12
`
` A. In thinking back, it may have been a year
`
`ago.
`
` Q. Okay. Dr. Do, I'm going to hand you a
`
`couple of documents that have been previously 09:16:02
`
`marked.
`
` First, your declaration in the '338 patent
`
`proceeding. That's Exhibit 2051.
`
` MR. SALMEN: I have a copy for you, Counsel.
`
` MS. FISHMAN: Thank you. 09:16:20
`
` MR. SALMEN: And there are extra copies.
`
` (Deposition Exhibit 2051 was previously
`
` marked.)
`
`BY MR. SALMEN:
`
` Q. So, Dr. Do, I'm also going to hand you a 09:16:27
`
`binder that I've prepared that has, just for
`
`convenience, several of the exhibits that you cite.
`
` (Telephonic interruption.)
`
` MR. SALMEN: Sorry for the interruption.
`
`BY MR. SALMEN: 09:16:46
`
` Q. This binder has several of the exhibits
`
`that you cite in there. And I'm giving this to you.
`
`All of the exhibits have been previously marked, so
`
`to the extent we address them, I'll call out the
`
`exhibit numbers. 09:16:57
`
`www.veritext.com
`
`888-391-3376
`
`Veritext Legal Solutions
`
`Mylan Exhibit 1109
`Mylan v. Regeneron, IPR2021-00880
`Page 12
`
`
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
` MR. SALMEN: There's one for you, Counsel. 09:16:58
`
`Page 13
`
` MS. FISHMAN: Thank you.
`
`BY MR. SALMEN:
`
` Q. Dr. Do, you consider Lucentis to be an
`
`effective treatment for angiogenic eye disorders; 09:17:24
`
`correct?
`
` A. May I ask which time frame are you
`
`referring to?
`
` Q. Prior to January 2011.
`
` A. Yes, as I stated in my declaration, 09:17:35
`
`Lucentis was the standard of care prior --
`
` Q. So referring to your declaration in
`
`paragraph 17.
`
` MS. FISHMAN: Counsel, please let the witness
`
`finish her answer when you're questioning her. 09:17:53
`
`Thank you.
`
`BY MR. SALMEN:
`
` Q. In paragraph 17 of your declaration, you
`
`state, "The claimed method of treating must achieve
`
`a high level of efficacy, one that is non-inferior 09:18:04
`
`to the existing standard of care at the time the
`
`'338 patent was filed."
`
` Do you see that?
`
` A. No. Where are you?
`
` Q. Paragraph 17. 09:18:18
`
`www.veritext.com
`
`888-391-3376
`
`Veritext Legal Solutions
`
`Mylan Exhibit 1109
`Mylan v. Regeneron, IPR2021-00880
`Page 13
`
`
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
` A. Okay. Thank you. 09:18:19
`
`Page 14
`
` Yes, I see paragraph 17.
`
` Q. The standard of care you're referring to
`
`there includes Lucentis; correct?
`
` A. Yes. In my declaration, I stated that at 09:18:30
`
`the time, prior to 2011, Lucentis was the standard
`
`of care.
`
` Q. Dr. Do, this is a cross-examination. I'm
`
`going to ask my questions. To the extent you can
`
`answer them yes or no, I ask that you answer them 09:18:46
`
`yes or no. I don't need further clarifications.
`
`Okay?
`
` A. (Nods head affirmatively.)
`
` Q. So prior to January 2011, you considered
`
`Lucentis to be a highly effective treatment for 09:18:58
`
`angiogenic eye disorders; correct?
`
` A. As stated in my declaration, prior to
`
`2011, Lucentis was the standard of care.
`
` Q. Okay. Lucentis was approved in 2006;
`
`correct? 09:19:14
`
` A. Yes, that is correct.
`
` Q. Are you familiar with the VIEW 1/VIEW 2
`
`trials?
`
` A. Yes, I'm familiar with those two clinical
`
`trials. 09:19:28
`
`www.veritext.com
`
`888-391-3376
`
`Veritext Legal Solutions
`
`Mylan Exhibit 1109
`Mylan v. Regeneron, IPR2021-00880
`Page 14
`
`
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
` Q. And at the time of the VIEW 1/VIEW 2 09:19:28
`
`Page 15
`
`trials, you agree that the standard of care was,
`
`quote, moved beyond observation and monitoring or
`
`destructive therapies such as laser and PDT;
`
`correct? 09:19:44
`
` MS. FISHMAN: Where are you reading from?
`
`Objection. Where are you reading from?
`
`BY MR. SALMEN:
`
` Q. Can you answer the question?
`
` A. Can you repeat the question. 09:19:54
`
` Q. At the time of the VIEW 1/VIEW 2 trials,
`
`you defined the standard of care as having, quote,
`
`moved beyond observation and monitoring or
`
`destructive therapies such as laser and PDT;
`
`correct? 09:20:09
`
` A. After Lucentis was approved, then the
`
`standard of care had changed. And Lucentis, because
`
`it was effective at improving vision or maintaining
`
`vision, had become the new standard of care.
`
` Q. So the answer to my question is "yes"; 09:20:28
`
`right?
`
` MS. FISHMAN: Objection; mischaracterizes
`
`testimony.
`
` But you can answer his question.
`
` THE WITNESS: The standard of care had evolved 09:20:38
`
`www.veritext.com
`
`888-391-3376
`
`Veritext Legal Solutions
`
`Mylan Exhibit 1109
`Mylan v. Regeneron, IPR2021-00880
`Page 15
`
`
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`because Lucentis was effective at improving vision 09:20:43
`
`Page 16
`
`or maintaining vision.
`
`BY MR. SALMEN:
`
` Q. Lucentis was highly effective; correct?
`
`That is the standard of care? 09:20:53
`
` A. Lucentis was very effective and it was the
`
`standard of care, highly effective.
`
` Q. I'll direct your attention to paragraph 65
`
`of your declaration. The header for this section
`
`before paragraph 65 is "Lucentis Approval and the 09:21:20
`
`New Standard of Care."
`
` Do you see that?
`
` A. Yes, I see that.
`
` Q. The standard of care that you are
`
`referring to is the administration of Lucentis or 09:21:31
`
`Avastin; is that correct?
`
` A. As stated in my declaration, at that time
`
`point, prior to 2011, Lucentis or off-label Avastin
`
`had become the standard of care because they could
`
`improve vision or maintain vision. 09:21:56
`
` Q. Okay. And in this paragraph, you
`
`specifically refer to "wet AMD" and that Lucentis or
`
`Avastin off label were the standard of care for that
`
`particular angiogenic eye disorder; correct?
`
` A. In paragraph 65, I mentioned wet AMD as 09:22:15
`
`www.veritext.com
`
`888-391-3376
`
`Veritext Legal Solutions
`
`Mylan Exhibit 1109
`Mylan v. Regeneron, IPR2021-00880
`Page 16
`
`
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`the reference here. 09:22:24
`
`Page 17
`
` Q. And if we turn to paragraph 54 of your
`
`declaration, you referred to many other angiogenic
`
`eye disorders, including wet AMD; correct?
`
` A. Correct. 09:22:47
`
` Q. So Lucentis, or off-label Avastin, were
`
`the standard of care for wet AMD as well as many
`
`other angiogenic eye disorders as of January 2011;
`
`correct?
`
` A. As of January 2011, Lucentis was FDA 09:23:02
`
`approved for both wet AMD and retinal vein
`
`occlusion. Simultaneously at that time, off-label
`
`Avastin was used in the ophthalmology community to
`
`treat other angiogenic eye disorders.
`
` Q. So you agree that Lucentis was also the 09:23:40
`
`standard of care for other angiogenic eye disorders
`
`at that time, prior to January 2011; correct?
`
` A. As I stated, Lucentis was FDA approved for
`
`wet AMD and retinal vein occlusion by January of
`
`2011 and was the standard of care for those two 09:24:05
`
`indications because of its FDA approval.
`
` However, off-label Avastin had also
`
`emerged as a standard of care option because it was
`
`highly efficacious in both -- in many of these
`
`angiogenic eye disorders. 09:24:27
`
`www.veritext.com
`
`888-391-3376
`
`Veritext Legal Solutions
`
`Mylan Exhibit 1109
`Mylan v. Regeneron, IPR2021-00880
`Page 17
`
`
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
` Q. So is it your testimony that Lucentis was 09:24:28
`
`Page 18
`
`not used off label prior to January 2011 to treat
`
`angiogenic eye disorders other than AMD and RVO?
`
` A. I did not provide an opinion on that in my
`
`declaration. But in my experience as an 09:24:46
`
`ophthalmologist, at that time, Lucentis was only FDA
`
`approved for wet AMD and retinal vein occlusion.
`
` Q. That's not my question, Dr. Do. You can
`
`answer my question.
`
` MS. FISHMAN: Objection; argumentative. 09:25:03
`
`BY MR. SALMEN:
`
` Q. Was Lucentis used off label prior to
`
`January 2011 to treat angiogenic eye disorders other
`
`than AMD and RVO, the indications that it was
`
`approved for? 09:25:15
`
` MS. FISHMAN: Again objection; argumentative.
`
` But you can answer.
`
` THE WITNESS: I did not offer an opinion on
`
`that specific question in my declaration. But in my
`
`experience, because it was not yet approved in other 09:25:29
`
`angiogenic eye disorders, Lucentis was only
`
`available to investigators in clinical trials at
`
`that time if the indications were not wet AMD or
`
`retinal vein occlusion.
`
`BY MR. SALMEN: 09:25:49
`
`www.veritext.com
`
`888-391-3376
`
`Veritext Legal Solutions
`
`Mylan Exhibit 1109
`Mylan v. Regeneron, IPR2021-00880
`Page 18
`
`
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
` Q. So prior to January 2007 -- strike that. 09:25:49
`
`Page 19
`
` Prior to January 2011, Avastin was being
`
`used off label to treat angiogenic eye disorders;
`
`correct?
`
` A. That is correct. 09:25:59
`
` Q. And Lucentis was available to licensed
`
`ophthalmologists prior to January 2011; correct?
`
` A. At that time period, as I stated, Lucentis
`
`was FDA approved for the treatment of wet AMD or
`
`retinal vein occlusion, and it was available for 09:26:21
`
`those indications.
`
` Q. Were you treating patients prior to
`
`January 2011 that were suffering from angiogenic eye
`
`disorders other than AMD and RVO?
`
` A. In my declaration, I did not provide an 09:26:36
`
`opinion on my clinical practice at that time.
`
` Q. I'm not asking for an opinion. I'm asking
`
`for factual information regarding your practice.
`
`I'll say it again.
`
` Prior to January 2011, were you treating 09:26:49
`
`patients suffering from angiogenic eye disorders
`
`other than AMD and RVO?
`
` MS. FISHMAN: Objection; argumentative.
`
` You can answer.
`
` THE WITNESS: In my experience as an 09:27:03
`
`www.veritext.com
`
`888-391-3376
`
`Veritext Legal Solutions
`
`Mylan Exhibit 1109
`Mylan v. Regeneron, IPR2021-00880
`Page 19
`
`
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`ophthalmologist, at that time period, before 2011, I 09:27:05
`
`Page 20
`
`was treating patients with angiogenic eye disorders.
`
`BY MR. SALMEN:
`
` Q. Okay. And did you treat those patients
`
`suffering from angiogenic eye disorders other than 09:27:15
`
`AMD and RVO prior to January 2011 with Lucentis?
`
` A. Prior to 2011 for many of these
`
`indications in clinic, I was using off-label
`
`Avastin. However, I was also an investigator on
`
`many Genentech-sponsored clinical trials where I 09:27:40
`
`used Lucentis in the setting of a clinical trial.
`
` Q. And that was off-label Lucentis that you
`
`were using; correct?
`
` MS. FISHMAN: Objection; lacks foundation and
`
`mischaracterizes testimony. 09:27:54
`
` You can answer.
`
` THE WITNESS: At that time period, for
`
`indications other than wet AMD or retinal vein
`
`occlusion, I was only using Lucentis as a clinical
`
`investigator using an IRB protocol to test Lucentis 09:28:12
`
`in different angiogenic eye disorders.
`
`BY MR. SALMEN:
`
` Q. Okay. How about in your current practice?
`
`So prior to today, in the years between January 2011
`
`and today, do you use Lucentis off label to treat 09:28:30
`
`www.veritext.com
`
`888-391-3376
`
`Veritext Legal Solutions
`
`Mylan Exhibit 1109
`Mylan v. Regeneron, IPR2021-00880
`Page 20
`
`
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`angiogenic eye disorders other than the ones that 09:28:35
`
`Page 21
`
`are approved indications in the Lucentis label?
`
` A. In my clinical practice, I use Lucentis in
`
`patients where Lucentis is FDA approved for their
`
`specific eye condition. 09:28:59
`
` Q. So is the answer then you do not use
`
`Lucentis off label in your current practice?
`
` A. Can you give me more clarification on your
`
`question.
`
` Q. I'm referring back to my original 09:29:21
`
`question.
`
` In your current practice, post
`
`January 2011 up until today, do you use Lucentis off
`
`label to treat angiogenic eye disorders other than
`
`in accordance with the approved indications in the 09:29:38
`
`label?
`
` A. Post 2011, I do not use Lucentis off
`
`label.
`
` Q. So you understand that "off label" refers
`
`to using Lucentis for angiogenic eye disorders that 09:29:51
`
`are not approved in the label; correct?
`
` A. Correct.
`
` Q. And you understand that using Lucentis
`
`"off label" also refers to administering Lucentis in
`
`a regimen that is not in the approved indication of 09:30:08
`
`www.veritext.com
`
`888-391-3376
`
`Veritext Legal Solutions
`
`Mylan Exhibit 1109
`Mylan v. Regeneron, IPR2021-00880
`Page 21
`
`
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`the Lucentis label; correct? 09:30:12
`
`Page 22
`
` MS. FISHMAN: Objection; lacks foundation.
`
` You can answer.
`
` THE WITNESS: Currently I do not use Lucentis
`
`off label. 09:30:25
`
`BY MR. SALMEN:
`
` Q. Is that how you're answering my question
`
`regarding the regimen?
`
` A. Can you repeat your question on the
`
`regimen. 09:30:35
`
` Q. What indications currently are Lucentis
`
`approved for?
`
` A. Which time frame are you referring to?
`
` Q. Currently.
`
` A. Currently, Lucentis is FDA approved for 09:31:07
`
`the treatment of wet age-related macular
`
`degeneration, diabetic macular edema, retinal vein
`
`occlusion, diabetic retinopathy, myopic choroidal
`
`neovascularization.
`
` Q. What is the approved dosing regimen in the 09:31:30
`
`current Lucentis label for age-related macular
`
`degeneration?
`
` A. Do you have a copy of the label?
`
` Q. Can you tell me -- you're a licensed
`
`ophthalmologist. 09:31:45
`
`www.veritext.com
`
`888-391-3376
`
`Veritext Legal Solutions
`
`Mylan Exhibit 1109
`Mylan v. Regeneron, IPR2021-00880
`Page 22
`
`
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
` In your experience -- in your current 09:31:45
`
`Page 23
`
`practice, do you have an understanding of what the
`
`approved dosing regimen is for age-related macular
`
`degeneration in the Lucentis label?
`
` MS. FISHMAN: Objection; argumentative. This 09:31:56
`
`isn't a memory test and the witness has asked for a
`
`copy of the document.
`
`BY MR. SALMEN:
`
` Q. Can you answer the question?
`
` A. In my recollection, Lucentis is FDA 09:32:08
`
`approved for the treatment of wet age-related
`
`macular degeneration as often as every four weeks.
`
` Q. So monthly dosing; correct?
`
` A. Monthly dosing can be employed, yes.
`
` Q. Is it approved for other dosing regimens? 09:32:26
`
` A. I believe in the label, it may suggest
`
`other dosing regimens, but I don't recall at this
`
`time. I would have to see the label.
`
` Q. I'm going to hand you what's previously
`
`been marked Exhibit 2185. 09:32:56
`
` (Deposition Exhibit 2185 was previously
`
` marked.)
`
`BY MR. SALMEN:
`
` Q. This is a 2011 version of the Lucentis
`
`label. 09:33:09
`
`www.veritext.com
`
`888-391-3376
`
`Veritext Legal Solutions
`
`Mylan Exhibit 1109
`Mylan v. Regeneron, IPR2021-00880
`Page 23
`
`
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
` A. What I have in front of me is a copy of 09:33:09
`
`Page 24
`
`the EYLEA label.
`
` Q. Oh. Yeah, you do. Okay. You can set
`
`that aside for now.
`
` What was the FDA-approved dosing regimen 09:33:33
`
`for treating angiogenic eye disorders with Avastin
`
`prior to 2011?
`
` MS. FISHMAN: Objection; lacks foundation.
`
` THE WITNESS: Can you repeat your question.
`
`BY MR. SALMEN: 09:33:47
`
` Q. What was the FDA-approved dosing regimen
`
`for treating angiogenic eye disorders with Avastin
`
`prior to January 2011?
`
` MS. FISHMAN: Objection; lacks foundation.
`
` You can answer. 09:33:58
`
` THE WITNESS: Avastin for use in angiogenic eye
`
`disorders was off label.
`
`BY MR. SALMEN:
`
` Q. There was no dosing regimen for Avastin
`
`that was approved by FDA to treat wet AMD, for 09:34:09
`
`example; correct?
`
` A. That is correct.
`
` Q. So in other words, all uses of Avastin to
`
`treat wet AMD were off-label dosing regimens;
`
`correct? 09:34:26
`
`www.veritext.com
`
`888-391-3376
`
`Veritext Legal Solutions
`
`Mylan Exhibit 1109
`Mylan v. Regeneron, IPR2021-00880
`Page 24
`
`
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
` A. That is correct. 09:34:28
`
`Page 25
`
` Q. So skilled ophthalmologists like yourself
`
`prior to January 2011 were able to administer
`
`Avastin to treat angiogenic eye disorders like wet
`
`AMD even though there was no FDA-approved dosing 09:34:44
`
`regimen; is that correct?
`
` A. That is correct.
`
` Q. Prior to January 2011, were skilled
`
`ophthalmologists like yourself able to use Lucentis
`
`off label to treat angiogenic eye disorders? 09:35:04
`
` A. I believe I answered that question
`
`already.
`
` Q. You answered it with respect to your own
`
`practice. I'm asking for the general community of
`
`skilled ophthalmologists. 09:35:18
`
` A. In my declaration, I did not provide an
`
`opinion on that. However, in my experience as an
`
`ophthalmologist, I do not recall ophthalmologists
`
`using Lucentis off label outside of its FDA-approved
`
`conditions. 09:35:43
`
` Q. So with respect to Avastin,
Accessing this document will incur an additional charge of $.
After purchase, you can access this document again without charge.
Accept $ Charge
Still Working On It
This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.
Give it another minute or two to complete, and then try the refresh button.
A few More Minutes ... Still Working
It can take up to 5 minutes for us to download a document if the court servers are running slowly.
Thank you for your continued patience.
This document could not be displayed.
We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.
Your account does not support viewing this document.
You need a Paid Account to view this document. Click here to change your account type.
Your account does not support viewing this document.
Set your membership
status to view this document.
With a Docket Alarm membership, you'll
get a whole lot more, including:
- Up-to-date information for this case.
- Email alerts whenever there is an update.
- Full text search for other cases.
- Get email alerts whenever a new case matches your search.
One Moment Please
The filing “” is large (MB) and is being downloaded.
Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.
Your document is on its way!
If you do not receive the document in five minutes, contact support at support@docketalarm.com.
Sealed Document
We are unable to display this document, it may be under a court ordered seal.
If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.
Access Government Site
