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` 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, IPR2021-00881
`Page 1
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` UNITED STATES PATENT AND TRADEMARK OFFICE
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`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, IPR2021-00881
`Page 2
`
`
`
`Page 3
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`A P P E A R A N C E S :
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`F O R T H E P E T I T I O N E R S :
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` 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
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` C h i c a g o , I l l i n o i s 6 0 6 5 4
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` ( 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
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` 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 :
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` 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
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` P a l o A l t o , C a l i f o r n i a 9 4 3 0 6
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` ( 6 5 0 ) 3 1 9 - 4 5 0 0
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`www.veritext.com
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`888-391-3376
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`Veritext Legal Solutions
`
`Mylan Exhibit 1109
`Mylan v. Regeneron, IPR2021-00881
`Page 3
`
`
`
`Page 4
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`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
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`Veritext Legal Solutions
`
`Mylan Exhibit 1109
`Mylan v. Regeneron, IPR2021-00881
`Page 4
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`
`
`Page 5
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` 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--
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`Veritext Legal Solutions
`
`Mylan Exhibit 1109
`Mylan v. Regeneron, IPR2021-00881
`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--
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`
`Veritext Legal Solutions
`
`Mylan Exhibit 1109
`Mylan v. Regeneron, IPR2021-00881
`Page 6
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`Page 7
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` 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, IPR2021-00881
`Page 7
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`94306. 09:11:20
`
`Page 8
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` 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, IPR2021-00881
`Page 8
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`This deposition is being taken in IPR2021-00881. 09:12:20
`
`Page 9
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` 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, IPR2021-00881
`Page 9
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`to? 09:13:28
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`Page 10
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` 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, IPR2021-00881
`Page 10
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`owner response with respect to the '069 patent? 09:14:39
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`Page 11
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` 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, IPR2021-00881
`Page 11
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` Q. When was your last deposition? 09:15:44
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`Page 12
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` 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, IPR2021-00881
`Page 12
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` MR. SALMEN: There's one for you, Counsel. 09:16:58
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`Page 13
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` 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, IPR2021-00881
`Page 13
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` A. Okay. Thank you. 09:18:19
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`Page 14
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` 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
`
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`Mylan v. Regeneron, IPR2021-00881
`Page 14
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` Q. And at the time of the VIEW 1/VIEW 2 09:19:28
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`Page 15
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`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
`
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`Mylan v. Regeneron, IPR2021-00881
`Page 15
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`because Lucentis was effective at improving vision 09:20:43
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`Page 16
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`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
`
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`Page 16
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`the reference here. 09:22:24
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`Page 17
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` 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
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`Mylan v. Regeneron, IPR2021-00881
`Page 17
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` Q. So is it your testimony that Lucentis was 09:24:28
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`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, IPR2021-00881
`Page 18
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` Q. So prior to January 2007 -- strike that. 09:25:49
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`Page 19
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` 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
`
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`Mylan v. Regeneron, IPR2021-00881
`Page 19
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`ophthalmologist, at that time period, before 2011, I 09:27:05
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`Page 20
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`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
`
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`Veritext Legal Solutions
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`Mylan Exhibit 1109
`Mylan v. Regeneron, IPR2021-00881
`Page 20
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`angiogenic eye disorders other than the ones that 09:28:35
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`Page 21
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`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
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`Mylan v. Regeneron, IPR2021-00881
`Page 21
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`the Lucentis label; correct? 09:30:12
`
`Page 22
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` 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
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`Veritext Legal Solutions
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`Mylan Exhibit 1109
`Mylan v. Regeneron, IPR2021-00881
`Page 22
`
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` In your experience -- in your current 09:31:45
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`Page 23
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`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
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`Mylan v. Regeneron, IPR2021-00881
`Page 23
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` A. What I have in front of me is a copy of 09:33:09
`
`Page 24
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`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, IPR2021-00881
`Page 24
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` A. That is correct. 09:34:28
`
`Page 25
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` 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,