Case 1:22-cv-00061-TSK-JPM Document 432-12 Filed 04/25/23 Page 1 of 90 PageID #:
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`Exhibit 10
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`Samsung Bioepis Exhibit 1075
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`Case 1:22-cv-00061-TSK-JPM Document 432-12 Filed 04/25/23 Page 2 of 90 PageID #:
`28044
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` IN THE UNITED STATES DISTRICT COURT
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` FOR THE NORTHERN DISTRICT OF
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` WEST VIRGINIA
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` Civil Action No. 1:22-cv-00061-TSK
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` ------------------------------------x
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` REGENERON PHARMACEUTICALS, INC.,
`
` Plaintiff,
`
` -against-
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` MYLAN PHARMACEUTICALS INC.,
`
` Defendant.
`
` ------------------------------------x
`
` 650 Fifth Avenue
`
` New York, New York
`
` December 16, 2022
`
` 9:12 a.m.
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` VIDEOTAPED HYBRID DEPOSITION of
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` KAREN CHU, a witness in the
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` above-entitled action, held at the above
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` time and place, taken before Dawn Matera,
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` a Shorthand Reporter and Notary Public of
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` the State of New York.
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`www.veritext.com
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`888-391-3376
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`Veritext Legal Solutions
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`Samsung Bioepis Exhibit 1075
`Page 2
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`Case 1:22-cv-00061-TSK-JPM Document 432-12 Filed 04/25/23 Page 3 of 90 PageID #:
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`1 THE VIDEOGRAPHER: Good morning.
`2 We are going on the record at
`3 a.m. Eastern Standard Time. Please
`4 note that the microphones are
`5 sensitive and may pick up whispering
`6 and private conversations. Please
`7 mute your phones at this time. Audio
`8 and video recording will continue to
`9 take place unless all parties agree to
`10 go off the record.
`11 This is media unit 1 of the
`12 video-recorded deposition of Karen Chu
`13 taken by counsel in the matter of
`14 Regeneron Pharmaceuticals, Inc. versus
`15 Mylan Pharmaceuticals, Inc., filed in
`16 the United States District Court for
`17 the Northern District of West
`18 Virginia, civil action number
`19 1:22-CV-00061-TSK.
`20 The location of this deposition
`21 is in the offices of Williams &
`22 Connolly, 650 Fifth Avenue, New York,
`23 New York. My name is Zef Cota and I
`24 am the videographer. The court
`25 reporter is Dawn Matera, from the firm
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`Page 3
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`Page 5
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`1 of Veritext.
`2 I am not authorized to
`3 administer an oath. I am not related
`4 to any party in this action nor am I
`5 financially interested in the outcome.
`6 Counsel and all present in the
`7 room have been noted for the
`8 stenographic record.
`9 Will the court reporter please
`10 swear in the witness and then counsel
`11 may proceed.
`12 K A R E N C H U, the Witness herein,
`13 having first been duly sworn by the
`14 Notary Public, was examined and testified
`15 as follows:
`16 EXAMINATION BY MS. MAZZOCHI:
`17 Q. Thank you. Good morning,
`18 Ms. Chu, my name is Deanne Mazzochi.
`19 Can you please state your full
`20 name and address for the record.
`21 A. Yes, Karen Chu, and my home
`22 address is 73 Richbell Road, White
`23 Plains, New York 10605.
`24 Q. Is this your first time given
`25 testimony under oath?
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`1 A P P E A R A N C E S : (Continued)
`
`2 3
`
` WILLIAMS & CONNOLLY LLP
` Attorneys for Regeneron Pharmaceuticals,
`4 Inc.
` 680 Maine Ave S.W.
`5 Washington, D.C. 20024
`6 By: ELLEN E. OBERWETTER, ESQ.
` eoberwetter@wc.com
`7 KATHRYN S. KAYALI, ESQ.
` kkayali@wc.com
`
`8 9
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` RAKOCZY MOLINO MAZZOCHI SIWIK LLP
`10 Attorneys for Mylan Pharmaceuticals
` 6 W. Hubbard Street
`11 Suite 500
` Chicago, Illinois 60654
`
`12
`
` By: DEANNE M. MAZZOCHI, ESQ.
`13 dmazzochi@rmmslegal.com
` (Remote Attendance)
`14 JEFFREY A. MARX, ESQ.
` jmarx@rmmslegal.com
`15 HEINZ J. SALMEN, ESQ.
` hsalmen@rmmslegal.com
`16 (Remote Attendance)
`17
`18 CAREY DOUGLAS KESSLER & RUBY PLLC
` Local Counsel for Regeneron
`19 Pharmaceuticals, Inc.
` 707 Virginia Street East
`20 901 Chase Tower
` Charleston, West Virginia 25301
`
`21
`
` By: DAVID POGUE, ESQ.
`22 drpogue@cdkrlaw.com
` (Remote Attendance.)
`
`23
`24
`25
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`1 A P P E A R A N C E S : (Continued)
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`23
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` STEPTOE & JOHNSON PLLC
` Local Counsel for Mylan
`4 707 Virginia Street East
` Chase Tower, 17th Floor
`5 Charleston, West Virginia 25301
`6 By: JOHN PIZZO, ESQ.
` john.pizzo@steptoe-johnson.com
`7 (Remote Attendance)
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`89
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`10 Also Present:
`11 ADAM BERNSTEIN, Regeneron
`12 PETRA SCAMBOROVA, Regeneron
`13 ZEF COTA, Videographer
`14 ~oOo~
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`www.veritext.com
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`Veritext Legal Solutions
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`2 (Pages 2 - 5)
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`888-391-3376
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`Samsung Bioepis Exhibit 1075
`Page 3
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`

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`Case 1:22-cv-00061-TSK-JPM Document 432-12 Filed 04/25/23 Page 4 of 90 PageID #:
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`1 A. I previously gave testimony
`2 under oath in a different case many, many
`3 years ago.
`4 Q. Okay. Do you recall -- did
`5 that case involve Regeneron?
`6 A. It did not.
`7 Q. Did it involve any VEGF
`8 inhibitors?
`9 A. It did not. It involved a
`10 personal liability suit against the
`11 summer camp I went to.
`12 Q. Have you participated at all in
`13 any FTC proceedings prior to being
`14 deposed in this case?
`15 A. No, I have not.
`16 Q. Have you been asked to provide
`17 documents or records in connection with
`18 any matter involving the United States
`19 government and Regeneron?
`20 A. I have not.
`21 Q. How about any claims involving
`22 a state government?
`23 A. No, not that I am aware.
`24 Q. How about any litigation
`25 involving Regeneron and an insurer or an
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`1 company here on the East Coast, Purdue
`2 Pharma. And then worked for them for
`3 approximately a little over two years
`4 before moving to a small contract
`5 research organization called Barton &
`6 Polansky, located here in New York City.
`7 After that, I joined a company
`8 that was headquartered in Gaithersburg,
`9 Maryland called GenVec. They were a gene
`10 therapy company. And after I left -- I
`11 was with GenVec for four years before
`12 joining Regeneron.
`13 Q. How did you get involved in or
`14 what training did you receive in
`15 connection with clinical -- human
`16 clinical trials?
`17 MS. OBERWETTER: Object to the
`18 form.
`19 You can answer it.
`20 A. Okay. Just a clarification,
`21 are you asking about training I received
`22 throughout my career or specific to
`23 Regeneron?
`24 Q. Right, throughout your career,
`25 because with an MS in nutrition, jumping
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`Page 7
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`Page 9
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`1 HMO?
`2 A. Not that I am aware of.
`3 Q. Have you received any subpoenas
`4 to appear before a state or federal grand
`5 jury?
`6 A. I have not received any
`7 subpoenas.
`8 Q. Can you please state for the
`9 record your educational background post
`10 high school?
`11 A. Sure. I have a bachelor's of
`12 science degree in biology from Cal Poly
`13 San Luis Obispo and a master's in human
`14 nutrition from Columbia University.
`15 Q. And can you please describe
`16 your employment history after you
`17 graduated from Columbia University with
`18 you are your MS in human nutrition?
`19 A. Sure. After graduation and
`20 completion of my degree, I joined a small
`21 biotech company located in the San
`22 Francisco Bay area called Seqirus
`23 Pharmaceuticals.
`24 After working at that company
`25 for a little over a year, I moved to a
`
`1 into quality assurance roles and clinical
`2 research roles such as at GenVec, you
`3 know, how did you -- what type of
`4 training did you get in order to --
`5 either in connection with those roles?
`6 A. Sure. So the very first
`7 position I had in clinical research was
`8 as a clinical trial assistant. And as
`9 part of my role I helped with the
`10 operations of clinical trials and
`11 received good clinical practice training
`12 as part of my role.
`13 So GCP training was provided
`14 both by in-house individuals as well as
`15 I've attended external courses on both
`16 good clinical practice, as well as
`17 international conference on harmonization
`18 practices.
`19 Q. Do you have any certifications
`20 in connection with either clinical
`21 practice work or the international
`22 harmonization standards?
`23 A. I do not hold any current
`24 certifications.
`25 Q. Have you previously?
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`www.veritext.com
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`Veritext Legal Solutions
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`Samsung Bioepis Exhibit 1075
`Page 4
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`Case 1:22-cv-00061-TSK-JPM Document 432-12 Filed 04/25/23 Page 5 of 90 PageID #:
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`1 A. Previously I did have a
`2 certified contract research associate
`3 certification.
`4 Q. And how did you get that?
`5 A. That required a certain number
`6 of hours as well as taking an exam
`7 through the Association of Clinical
`8 Research Professionals.
`9 Q. Is there a reason why you
`10 allowed your certification on that to
`11 lapse?
`12 A. So in my over 25 years of
`13 experience in clinical development, it
`14 was not critical to the role I have now
`15 and felt that it was not necessary to
`16 keep that certification.
`17 Q. All right. Tell me how you
`18 came to be employed at Regeneron?
`19 A. So the company I worked for
`20 just prior to Regeneron, GenVec, was a
`21 small biotechnology firm, and they were
`22 having some, as many biotechnology
`23 companies do, some troubles with funding
`24 as well as some hiccups in terms of being
`25 able to move products forward in their
`
`1 for a lot of small companies, in that
`2 role wore several different hats and had
`3 a broad range of responsibilities as it
`4 related to clinical development. And
`5 over the years moved into more of a
`6 clinical project management role and then
`7 finally into my current role.
`8 Q. Okay. And was your initial
`9 title, what was it, director of
`10 therapeutic area, project management?
`11 A. So that was not my first title
`12 at Regeneron.
`13 Q. Okay. What was your first
`14 title?
`15 A. My recollection is that my
`16 first title was senior clinical trial
`17 manager. But the director of therapeutic
`18 area project management was a promotion
`19 into a broader clinical project
`20 management role.
`21 Q. And then did you ever have any
`22 individuals who reported to you in those
`23 roles?
`24 A. At the time that I was a
`25 clinical trial manager I had a group of
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`Page 11
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`1 pipeline. And at the time I was working
`2 both on a product they had in development
`3 for oncology as well as ophthalmology.
`4 And when the company conducted a round of
`5 layoffs I personally was not laid off,
`6 but it certainly signaled some
`7 uncertainty in the company's future. I
`8 made a decision to start looking
`9 potentially for another position.
`10 At the time I was already
`11 living in the New York area and Regeneron
`12 was very much in the news because of
`13 their -- because of the VEGF-Trap
`14 molecule and their work in oncology. And
`15 so I networked with a friend of mine and
`16 contacted a few people in the company to
`17 see if they had a need for somebody with
`18 my background. Dr. Jesse Cedarbaum was
`19 the person who hired me first at
`20 Regeneron.
`21 Q. And then what was your initial
`22 role and responsibilities at Regeneron?
`23 A. So when I joined the company I
`24 joined as a senior clinical trial
`25 manager. And then as is true, I think,
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`Page 13
`1 people that reported to me who, who were
`2 more junior clinical trial managers and
`3 involved in the operations of the
`4 clinical trials.
`5 Q. Okay. How do you differentiate
`6 what your role was versus what you call
`7 the operations of the clinical trials?
`8 A. So within clinical research,
`9 there are several people who contribute
`10 to any aspect of conducting a clinical
`11 trial. So the actual operations of the
`12 clinical trial, which includes everything
`13 from ensuring that clinical study sites
`14 are identified and trained appropriately
`15 to providing supplies for the clinical
`16 study sites, to deciding which
`17 laboratories to use or how labs will be
`18 collected. That typically is considered
`19 part of the operations role. So they're
`20 really, that, you know, they really
`21 oversee the actual execution of the
`22 clinical trials.
`23 Q. Okay. And then who -- when you
`24 were at Regeneron, say, in the -- when
`25 you first joined Regeneron, who was
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`888-391-3376
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`Samsung Bioepis Exhibit 1075
`Page 5
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`Case 1:22-cv-00061-TSK-JPM Document 432-12 Filed 04/25/23 Page 6 of 90 PageID #:
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`1 responsible for the actual design of
`2 clinical trials?
`3 MS. OBERWETTER: Object to the
`4 form.
`5 You can answer.
`6 A. Could you be more specific? Do
`7 you mean broadly all clinical trials at
`8 Regeneron or are you asking specifically
`9 about trials with VEGF-Trap.
`10 Q. Let's focus on VEGF-Trap. If I
`11 call VEGF-Trap aflibercept, is that all
`12 right as well?
`13 A. That's all right. I understand
`14 it to be the same molecule.
`15 Q. Okay. Got it. So we can focus
`16 on aflibercept?
`17 A. At the time I joined Regeneron,
`18 Dr. Jesse Cedarbaum was the vice
`19 president responsible for designing
`20 clinical trials, but all clinical trial
`21 designs were also vetted with senior
`22 management including individuals like Len
`23 Schleifer and George Yancopoulos.
`24 Q. Okay. And Len at the time was
`25 the CEO?
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`1 seen this document in the context of my
`2 preparation for my deposition and this
`3 does appear to be the '601 patent.
`4 MS. MAZZOCHI: Great. Let me
`5 put in front of you a document that
`6 we'll mark as Defendant's Exhibit 5,
`7 U.S. Patent Number is 11,253,572, and
`8 can you confirm that Exhibit 5 placed
`9 before you is the '572 patent?
`10 (Defendant's Exhibit 5, U.S.
`11 Patent Number 11,253,572, was so
`12 marked for identification, as of this
`13 date.)
`14 MS. OBERWETTER: Can I just ask
`15 by way of exhibit numbering, are these
`16 sequential of what happened yesterday?
`17 MS. MAZZOCHI: Ellen, because we
`18 have so many depositions going on,
`19 several of the exhibits that we know
`20 are likely to get used over and over
`21 again, we've premarked them. So we're
`22 not marking the same one over and
`23 over.
`24 MS. OBERWETTER: That's fine.
`25 MS. MAZZOCHI: With different
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`Page 15
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`1 A. Yes, Dr. Schleifer was the CEO
`2 then as he is now.
`3 Q. And George Yancopoulos was the
`4 senior, I think, chief scientific
`5 officer?
`6 A. I actually don't remember what
`7 his title was when I joined the company,
`8 but his current title is chief scientific
`9 officer.
`10 MS. MAZZOCHI: That's fine. I
`11 would like to put in front of you a
`12 document I will mark as Defendant's
`13 Exhibit 4, which is United States
`14 patent number 10,888,601B2. If you
`15 can just confirm that's a document
`16 that was put in front of you.
`17 (Defendant's Exhibit 4, United
`18 States Patent Number 10,888,601 B2,
`19 was so marked for identification, as
`20 of this date.)
`21 Q. Have you confirmed that you
`22 have seen that document before and that
`23 Exhibit 4 is the '601 patent?
`24 (Witness reviews document.)
`25 A. I can confirm that yes I have
`
`1 numbers.
`2 MS. OBERWETTER: Okay. Makes
`3 sense.
`4 A. So, sorry, Deanne, can you ask
`5 your question again?
`6 Q. Sure. Ms. Chu, can you just
`7 confirm Exhibit 5 placed before you is
`8 the '572 patent?
`9 A. Yes, this appears to be the
`10 '572 patent.
`11 Q. And you have seen this document
`12 before?
`13 A. I have seen this document in
`14 preparation for this deposition.
`15 MS. MAZZOCHI: Okay. And let me
`16 provide you with a document that I
`17 will mark as DX 200, which is titled
`18 "Plaintiff's Rule 26(a) Initial
`19 Disclosures."
`20 (Defendant's Exhibit 200,
`21 Plaintiff's Rule 26(a) Initial
`22 Disclosures, was so marked for
`23 identification, as of this date.)
`24 Q. And can you confirm the
`25 document before you marked as DX 200 is
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`888-391-3376
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`Samsung Bioepis Exhibit 1075
`Page 6
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`Case 1:22-cv-00061-TSK-JPM Document 432-12 Filed 04/25/23 Page 7 of 90 PageID #:
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`1 titled "Plaintiff's Rule 26(a) Initial
`2 Disclosures"?
`3 MS. OBERWETTER: Object to the
`4 foundation.
`5 You can answer.
`6 A. So I can confirm that the
`7 document says Plaintiff's Rule 26(a)
`8 Initial Disclosures.
`9 Q. Okay. If you can take a look
`10 at the third page of the exhibit, there
`11 is a table there and the second entry in
`12 the table says Karen Chu. Let me know
`13 when you've gotten to that entry?
`14 A. I see that entry.
`15 Q. Okay. Now it states, for you,
`16 Karen Chu, that one of the subject
`17 matters that you have knowledge of is the
`18 conception and reduction of practice of
`19 the inventions disclosed and/or claimed
`20 in the '879, '338, '069, '681, '205, '601
`21 and '572 patents and the clinical
`22 properties of aflibercept.
`23 Do you see that?
`24 A. I do see that.
`25 Q. Do you know if that's a true
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`Page 20
`1 mind, the term "conception" when it comes
`2 to any inventions disclosed?
`3 MS. OBERWETTER: Object to the
`4 form.
`5 A. I mean, I understand the word
`6 and what it could mean.
`7 Q. Okay. What's your
`8 understanding?
`9 MS. OBERWETTER: Object to the
`10 form.
`11 You can answer it.
`12 A. Okay. Obviously, the
`13 conception would be certainly the idea or
`14 the decision to move forward with any
`15 specific aspect of a clinical study
`16 design or development for a product.
`17 Q. And what's your understanding
`18 of the term "reduction to practice" when
`19 it comes to the inventions disclosed in
`20 the patents listed here in association
`21 with you?
`22 MS. OBERWETTER: Object to the
`23 form and foundation.
`24 You can answer.
`25 A. I don't think I can adequately
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`Page 21
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`1 statement, that you have knowledge on
`2 those issues?
`3 MS. OBERWETTER: Object to the
`4 foundation with this witness.
`5 You can answer.
`6 A. So it's difficult for me to
`7 answer this question because I don't know
`8 precisely the content of the listed
`9 patents, as well as the legal concept of
`10 conception and reduction of practice are
`11 not terms I am familiar with.
`12 Q. Okay. Well, do you have a
`13 layperson's understanding of conception
`14 and reduction to practice?
`15 MS. OBERWETTER: Object to the
`16 form.
`17 A. I don't know what the
`18 layperson's understanding of those would
`19 be. However, I can say that my entire
`20 almost 20-year career at Regeneron was in
`21 clinical development of aflibercept.
`22 Q. Okay. All right. Well, maybe
`23 we can get at it this way.
`24 Do you have an understanding as
`25 to what it means, you know, in your own
`
`1 speak to the meaning of that phrase.
`2 Q. Right. I am just asking for
`3 your understanding. Do you have any
`4 understanding as to what that term means?
`5 MS. OBERWETTER: Same objection.
`6 A. I have a very rudimentary
`7 understanding of what that means --
`8 Q. Okay.
`9 A. -- in the context of the
`10 patent.
`11 Q. What's your understanding?
`12 MS. OBERWETTER: Same objection.
`13 A. Just that the reduction to
`14 practice of the inventions would mean how
`15 exactly the patent translates to the
`16 products used.
`17 Q. Do you have an understanding of
`18 whether you will be called to testify at
`19 trial in this case?
`20 MS. OBERWETTER: Object to the
`21 form and foundation.
`22 A. My understanding is that I am
`23 on the witness list but I am not aware
`24 that it's been confirmed that I would be
`25 called to testify.
`
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`Samsung Bioepis Exhibit 1075
`Page 7
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`Case 1:22-cv-00061-TSK-JPM Document 432-12 Filed 04/25/23 Page 8 of 90 PageID #:
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`1 Q. Okay. Do you have any
`2 understanding as to what types of issues
`3 we can expect you to offer testimony on
`4 when it comes to trial in this case?
`5 MS. OBERWETTER: Object to the
`6 form and foundation.
`7 To the extent your answer would
`8 reveal any discussions with counsel,
`9 calls for attorney/client privileged
`10 information and work product.
`11 Q. You can answer.
`12 A. Sorry, could you ask your
`13 question again?
`14 Q. Sure. Do you have any
`15 understanding of what types of issues you
`16 will be offering -- you will be offering
`17 testimony on during trial in this case?
`18 MS. OBERWETTER: Object to the
`19 foundation. Same objection I just
`20 made.
`21 To the extent your answer would
`22 reveal any discussions with counsel,
`23 instruct the witness not to answer.
`24 Q. You can answer.
`25 A. My understanding is that I
`
`1 exactly this witness is going to be
`2 offering factual testimony on at
`3 trial. So if she has an understanding
`4 as to why and what facts she's going
`5 to be, or what issues she's going to
`6 be discussing at trial, we have a
`7 right to know and that doesn't -- that
`8 doesn't invade any of your
`9 conversations that you may have had
`10 with her.
`11 MS. OBERWETTER: That's
`12 completely incorrect. So please reask
`13 your question and I will make the
`14 appropriate instruction.
`15 MS. MAZZOCHI: Sure.
`16 Q. Outside of any conversations
`17 that you had with counsel, do you have
`18 any understanding as to what types of
`19 issues you might be discussing at trial
`20 in this case?
`21 MS. OBERWETTER: Object to the
`22 foundation.
`23 Q. You can answer.
`24 A. My only understanding of my
`25 role is that I would be offering --
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`1 would be asked questions --
`2 MS. OBERWETTER: You are
`3 instructed not to answer if it
`4 would -- if it would reveal any
`5 discussions with counsel.
`6 THE WITNESS: Okay.
`7 MS. MAZZOCHI: Fine.
`8 Q. Separate and apart from your
`9 discussions with counsel, do you have any
`10 understanding as to what knowledge you
`11 are going to be offering at trial in this
`12 case?
`13 MS. OBERWETTER: Deanne, you
`14 know this is improper.
`15 MS. MAZZOCHI: Actually, Ellen,
`16 I don't know that it's improper
`17 because we, you know, she just
`18 indicated that you identified her as
`19 someone who had knowledge on
`20 conception and reduction to practice
`21 issues and she doesn't necessarily
`22 know what that means.
`23 We're in the discovery phase in
`24 a very expedited schedule. We are
`25 trying to get an understanding of what
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`1 MS. OBERWETTER: To the
`2 extent -- Ms. Chu, to the extent your
`3 answer is informed by conversations
`4 with counsel, I will instruct you not
`5 to answer.
`6 THE WITNESS: Okay.
`7 A. I would prefer not to answer
`8 based on counsel instructions.
`9 Q. Well, are you saying that you
`10 have no information to give outside of
`11 any conversations you had with legal
`12 counsel?
`13 A. In regards to this specific
`14 topic, that is correct.
`15 Q. And just with regard to your
`16 role or experience with aflibercept, to
`17 the extent it might relate to any of
`18 these patents, you don't have any
`19 knowledge or understanding outside of
`20 your conversations with counsel as to
`21 what topics or issues you might have
`22 knowledge of to testify about at trial?
`23 MS. OBERWETTER: Object to the
`24 form and foundation of the question.
`25 MS. MAZZOCHI: You can answer.
`
`www.veritext.com
`
`Veritext Legal Solutions
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`7 (Pages 22 - 25)
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`888-391-3376
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`Samsung Bioepis Exhibit 1075
`Page 8
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`Case 1:22-cv-00061-TSK-JPM Document 432-12 Filed 04/25/23 Page 9 of 90 PageID #:
`28051
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`1 A. Can you ask the question again,
`2 please?
`3 MS. MAZZOCHI: Yeah, I will ask
`4 the court reporter to repeat it,
`5 please.
`6 (The record was read as follows:
`7 "Question: And just with regard
`8 to your role or experience with
`9 aflibercept, to the extent it might
`10 relate to any of these patents, you
`11 don't have any knowledge or
`12 understanding outside of your
`13 conversations with counsel as to what
`14 topics or issues you might have
`15 knowledge of to testify about at
`16 trial?")
`17 MS. OBERWETTER: Same objection.
`18 A. So outside of my conversations
`19 with counsel, I have spent almost 20
`20 years at Regeneron working on the
`21 development of aflibercept, most
`22 specifically in ophthalmology.
`23 Q. Okay. And, again, setting
`24 aside any conversations or knowledge that
`25 you gained from counsel, do you have any
`
`1 circumstances that lead to the invention
`2 of anything set forth in this '601 patent
`3 that you might testify to at trial.
`4 MS. OBERWETTER: Is there a
`5 question?
`6 MS. MAZZOCHI: Yeah, I am asking
`7 her to identify what knowledge she
`8 might have relating -- that she could
`9 potentially testify to at trial
`10 relating to the circumstances
`11 involving the inventions set forth in
`12 the '601 patent, DX 4.
`13 MS. OBERWETTER: May I suggest,
`14 do you want to just ask her what she
`15 knows instead of asking her about what
`16 she might testify to at trial?
`17 MS. MAZZOCHI: No, because,
`18 Ellen, our concern is that we don't
`19 necessarily know why this witness
`20 would be the person called to testify
`21 on various issues in connection with
`22 these patents at trial because she's
`23 not listed as the named inventor. So
`24 we want to get an understanding so
`25 we're not surprised at trial, as to,
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`Page 27
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`1 understanding as to what issues or topics
`2 you might be testifying about with regard
`3 to the aflibercept molecule that would be
`4 relevant to any of these patents?
`5 MS. OBERWETTER: Again, outside
`6 of any conversations with counsel, to
`7 the extent you can answer.
`8 A. Yeah, I do not have any
`9 knowledge outside of conversations with
`10 counsel.
`11 Q. Okay. Do you have any
`12 knowledge relating to the circumstances
`13 leading to the invention of what's
`14 described in the '601 patent that's
`15 before you, DX 4?
`16 MS. OBERWETTER: Object to the
`17 form and foundation.
`18 You can answer.
`19 A. Could you be more specific
`20 about what aspect of the patent you're
`21 referring to?
`22 Q. Well, I think that's part of
`23 the problem. You know, I'm trying to get
`24 an understanding as to where you might
`25 actually have knowledge relating to the
`
`Page 29
`1 you know, what knowledge or facts she
`2 may have relating to the circumstances
`3 involving the invention of the '601
`4 patent, inventions set forth in the
`5 '601 patent.
`6 MS. OBERWETTER: There are ways
`7 that do that don't involve asking her
`8 what she would testify about at trial.
`9 I have no interest in disrupting
`10 your examination. There are ways to
`11 do it where I don't have to object
`12 every time, because you're asking her
`13 what she's going to testify about at
`14 trial, which is not something this
`15 witness possibly could know. She
`16 knows what she knows. You can ask her
`17 about what she knows.
`18 MS. MAZZOCHI: Well, I like
`19 the -- the frame of my questions
`20 stand.
`21 MS. OBERWETTER: All right.
`22 Q. You can answer.
`23 MS. OBERWETTER: What's the
`24 pending question?
`25 MS. MAZZOCHI: I'll ask the
`
`www.veritext.com
`
`Veritext Legal Solutions
`
`8 (Pages 26 - 29)
`
`888-391-3376
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`Samsung Bioepis Exhibit 1075
`Page 9
`
`

`

`Case 1:22-cv-00061-TSK-JPM Document 432-12 Filed 04/25/23 Page 10 of 90 PageID #:
`28052
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`1 court reporter to read it back.
`2 (The record was read as follows:
`3 "Question: I'm trying to get an
`4 understanding as to where you might
`5 actually have knowledge relating to
`6 the circumstances that lead to the
`7 invention of anything set forth in
`8 this '601 patent that you might
`9 testify to at trial.")
`10 MS. OBERWETTER: Object to the
`11 form and foundation.
`12 A. So the claims in the '601
`13 patent cover methods and treatment for
`14 age-related macular degeneration,
`15 diabetic macular edema and
`16 diabetic retinopathy with aflibercept.
`17 And in my role at Regeneron, I was part
`18 of the team that designed the studies and
`19 conducted the studies related to these
`20 claims in the patent.
`21 Q. Okay. Do you have any
`22 understanding as to what part of that
`23 design process was inventive?
`24 MS. OBERWETTER: Object to the
`25 form and foundation.
`
`1 potential advantages and designed the
`2 trial in a way that we felt we could
`3 demonstrate those unique properties to
`4 the best extent possible.
`5 Q. Do you recall any unusual
`6 obstacles or anything that you had to
`7 overcome when designing the clinical
`8 trials for aflibercept particularly with
`9 regard to uses in the eye?
`10 MS. OBERWETTER: Object to the
`11 form. Compound. And it appears to
`12 sweep in every trial for aflibercept.
`13 Q. You can answer.
`14 A. Sorry, can you just repeat your
`15 question one more time?
`16 Q. Sure. Do you recall there
`17 being any particular obstacles or
`18 challenges that you encountered when
`19 designing any clinical trials for
`20 aflibercept in the eye?
`21 MS. OBERWETTER: Object to the
`22 form.
`23 A. So that's a very broad
`24 question. I'm not sure I can answer it
`25 adequately. Just to say that in
`
`Page 31
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`Page 33
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`1 A. I'm not sure I completely
`2 understand the use of the word
`3 "inventive" in your question. Could you
`4 be more specific?
`5 Q. Sure. Again, I'm just trying
`6 to get at what are identified as alleged
`7 inventions in Defendant's Exhibit 4, the
`8 '601 patent. You said that in your role
`9 you participated in the design of the
`10 studies,