UNITED STATES PATENT AND TRADEMARK OFFICE
`
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`Page 1
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`MYLAN PHARMACEUTICALS, INC., ) CASE IPR2021-00880
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`CELLTRION, INC., and APOTEX, INC., ) Patent 9,669,069 B2
`
` Petitioners, )
`
`vs. ) CASE IPR2021-00881
`
`REGENERON PHARMACEUTICALS, INC., ) Patent 9,254,338 B2
`
` Patent Owner )
`
`____________________________________) CONFIDENTIAL
`
` VIDEO DEPOSITION OF ALEXANDER M. KLIBANOV, PH.D.
`
` MARCH 24, 2022
`
` Reported by: Rosalie A. Kramm, CSR No. 5469, CRR
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`www.veritext.com
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`888-391-3376
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`Veritext Legal Solutions
`
`Mylan Exhibit 1108
`Mylan v. Regeneron, IPR2021-00880
`Page 1
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`

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`Page 2
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`Page 4
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`1 I N D E X (continued)
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`DEPOSITION EXHIBIT: PAGE
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`2 3
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`4 Exhibit 9 - CAS registry for No 862111-32-8 103
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`5 Exhibit 10 - 10-Q 1, Regeneron_10q htm QUARTERLY 106
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`6 REPORT
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`7 Exhibit 11 - Article, "VEGF Trap-Eye for the 112
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`8 treatment of neovascular age-related
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`9 macular degeneration"
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`10 Exhibit 12 - Article, "VEGF Trap complex 127
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`11 formulation measures production rates
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`12 of VEGF, providing a biomarker for
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`13 predicting efficacious angiogenic
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`14 blockade"
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`15 Exhibit 13 - Article, "VEGF Trap induces 129
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`16 antiglioma effect at different stages
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`17 of disease"
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`18 Exhibit 14 - Article, "Inhibition of Vascular 134
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`19 Endothelial Growth Factor in the
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`20 Primate Ovary Up-Regulates
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`21 Hypoxia-Inducible Factor 1 alpha in
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`22 the Follicle and Corpus Luteum"
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`23 Exhibit 15 - U S Patent No 7,374,758 B2 137
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`24 Exhibit 16 - APPLICATION FOR EXTENSION OF PATENT 141
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`25 TERM UNDER 35 U S C , Section 156"
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`1 APPEARANCES
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`2 3
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`FOR THE PETITIONER:
`4 RAKOCZY MOLINO MAZZOCHI SIWIK
`5 BY: NEIL B. McLAUGHLIN, PH.D., ESQ.
`6 BY: HEINZ J. SALMEN, ESQ.
`7 BY: THOMAS H. EHRICH, ESQ.
`8 Six West Hubbard Street
`9 Chicago, Illinois 60654
`10 312.222.7241
`11 nmclaughlin@rmmslegal.com
`12 hsalmen@rmmslegal.com
`13 tehrich@rmmslegal.com
`14
`15 FOR THE PATENT OWNER:
`16 ARNOLD & PORTER
`17 BY: JEREMY COBB, ESQ.
`18 601 Massachusetts Avenue, NW
`19 Washington, DC 20001-3743
`20 202.942.6828
`21 jeremy.cobb@arnoldporter.com
`22
`23 ALSO PRESENT: ELAINE WOO
`24 ALSO PRESENT: STEPHEN GAUDET
`25 THE VIDEOGRAPHER: KEVIN MONTGOMERY
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`Page 3
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`Page 5
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`1 I N D E X
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`1 I N D E X (continued)
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`2 3
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`DEPOSITION EXHIBIT: PAGE
`4 Exhibit 17 - Article, "A Phase I study of 160
`5 Intravitreal Vascular Endothelial
`6 Growth Factor Trap-Eye in Patients
`7 with Neovascular Age-Related Macular
`8 Degeneration"
`9 Exhibit 18 - Excerpt from journal Eye, Volume 29, 164
`10 pages 293 to 293
`11 Exhibit 19 - Article, "Increase of Plasma VEGF 166
`12 after Intravenous Administration of
`13 Bevacizumab Is Predicted by a
`14 Pharmacokinetic Model"
`15 Exhibit 20 - Article, "Comparison of binding 168
`16 characteristics and in vitro
`17 activities of three inhibitors of
`18 vascular endothelial growth factor A"
`19 Exhibit 21 - Article, "A novel engineered VEGF 169
`20 blocker with an excellent
`21 pharmacokinetic profile and robust
`22 antitumor activity"
`23 Exhibit 22 - WHO Drug Information," Volume 20, 179
`24 No. 2, 2006
`25 //
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`2 3
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`EXAMINATION PAGE
`4 BY MR. McLAUGHLIN 9
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`5 6
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`DEPOSITION EXHIBIT: PAGE
`7 Exhibit 1 - Expert Declaration of 10
`8 Alexander M. Klibanov, Ph.D.
`9 Exhibit 2 - Curriculum Vitae of Alexander M. 10
`10 Klibanov
`11 Exhibit 3 - Declaration of Alexander M. Klibanov, 24
`12 Ph.D., in Support of Defendants'
`13 Opposition to Amgen's Infringement
`14 Motion for Summary Judgment of
`15 Infringement of '422 Claim 1, '933
`16 Claim 3, and '698 Claim 6
`17 Exhibit 4 - Article, VEGF-Trap: A VEGF blocker 41
`18 with potent antitumor effects
`19 Exhibit 5 - U.S. Patent 7,531,173 B2 - Ophthalmic 60
`20 Composition of a VEGF Antagonist
`21 Exhibit 6 - Alignment of amino acid sequences of 64
`22 SEQ. ID No:2 of the '173 patent
`23 Exhibit 7 - U.S. Patent 9,254,338 B2 67
`24 Exhibit 8 - Article, "Aflibercept"; from Adis 72
`25 R&D Profile
`
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`Mylan Exhibit 1108
`Mylan v. Regeneron, IPR2021-00880
`Page 2
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`Page 6
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`Page 8
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`1 everyone attending remotely will now state their
`2 appearances and affiliations for the record.
`3 If there are any objections to proceeding,
`4 please state them at the time of your appearance,
`5 beginning with the noticing attorney.
`6 MR. McLAUGHLIN: Neil McLaughlin from the Law
`7 Offices of Rakoczy Molino Mazzochi Siwik on behalf of
`8 Petitioners, Mylan Pharmaceuticals, Inc.
`9 MR. COBB: Jeremy Cobb with Arnold & Porter on
`10 behalf of Patent Owner, Regeneron.
`11 MS. WOO: Eileen Woo from Regeneron.
`12 THE REPORTER: People on the phone, please?
`13 MR. GAUDET: Stephen Gaudet from Regeneron.
`14 MR. SALMEN: Hi, this is Heinz Salmen of
`15 Rakoczy Molino Mazzochi Siwik on behalf of Petitioner,
`16 Mylan.
`17 MR. EHRICH: Thomas Ehrich of Rakoczy Molino
`18 Mazzochi Siwik on behalf of Petitioner Mylan
`19 Pharmaceuticals, Incorporated.
`20 THE VIDEOTAPE OPERATOR: At this time, the
`21 court reporter will now swear in the witness.
`22 * * *
`23
`24
`25 //
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`1 I N D E X (continued)
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`2 3
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`DEPOSITION EXHIBIT: PAGE
`4 Exhibit 23 - Alignment conducted using SEQ. 182
`5 ID No:2 in the '338 patent
`6 Exhibit 24 - Textbook, "Biochemistry" 187
`7 Exhibit 25 - Article, "Lessons learned from 190
`8 biosimilar epoetins and insulins"
`9 Exhibit 26 - Slide deck, "Zaltrap Non-Comparability 198
`10 Issue"
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`1 MARCH 24, 2022 9:47 A M THURSDAY SAN DIEGO, CALIFORNIA
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`2 THE VIDEOTAPE OPERATOR: Good morning We are
`
`1 ALEXANDER M. KLIBANOV,
`2 having been first duly sworn, testified as follows:
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`Page 7
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`Page 9
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`3 4
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` EXAMINATION
`5 BY MR. McLAUGHLIN:
`6 Q. Dr. Klibanov, how many times have you been
`7 deposed?
`8 A. Good morning, Mr. McLaughlin.
`9 I would say over the last 25, 30 years, maybe
`10 three dozen times.
`11 Q. And how many of those were patent cases?
`12 A. You'll have to slow down, Mr. McLaughlin.
`13 Could you repeat your question slower, please?
`14 Q. How many of those cases were patent cases?
`15 A. The vast majority of them.
`16 Q. How many of those were you deposed on behalf of
`17 the patentee?
`18 A. I don't know. I've been deposed in cases, both
`19 on behalf of patent holders and on behalf of patent
`20 challengers, but I don't know what the breakdown is.
`21 Q. You don't recall sitting here today how many
`22 times you've testified on behalf of patentees?
`23 A. That's what I said.
`24 Once again, you'll have to slow down, sir.
`25 Q. How much time did you spend prepping for
`
`3 now on the record at 9:47 a m on March 24th, 2022
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`4 Please note that the microphones are sensitive and may
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`5 pick up whispering, private conversations, and cellular
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`6 interference Please turn off all cell phones or place
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`7 them away from the microphones as they can interfere with
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`8 the deposition audio Audio and video recording will
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`9 continue to take place unless all parties agree to go off
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`10 the record
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`11 This is Media Unit 1 of the Video Recorded
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`12 Deposition of Alexander Klibanov, Ph D in the matter of
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`13 Mylan Pharmaceuticals, Incorporated, et al , vs
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`14 Regeneron Pharmaceuticals, Incorporated, et al, filed in
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`15 the United States Patent and Trademark Office, before the
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`16 Patent and Appeal Board, Case Nos IPR02021-00880 and IPR
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`17 2021-00881
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`18 This deposition is taking place at Fish &
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`19 Richardson, located at 122860 El Camino Real, Suite 400,
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`20 San Diego, California 92130 My name is Kevin Montgomery
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`21 from the firm Veritext, and I'm the videographer The
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`22 court reporter is Rosalie Kramm from the firm Veritext
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`23 I am not related to any party in this action, nor am I
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`24 financially interested in the outcome
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`25 Counsel and all present in the room and
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`Mylan v. Regeneron, IPR2021-00880
`Page 3
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`Page 10
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`1 today's deposition?
`2 A. Several hours.
`3 Q. Approximately how many?
`4 A. All together, maybe close to ten.
`5 Q. Was that over the course of a single day or
`6 multiple days?
`7 A. Multiple days.
`8 Q. Which days were those?
`9 A. Yesterday, the day before yesterday, and also a
`10 few hours last week.
`11 (Exhibit 1 was marked for identification.)
`12 MR. McLAUGHLIN: Dr. Klibanov, I'm going to be
`13 handing you what has been marked as Exhibit 1.
`14 (Exhibit 2 was marked for identification.)
`15 MR. McLAUGHLIN: I'm also going to be handing
`16 you what has been marked as Exhibit 2.
`17 THE WITNESS: Thank you.
`18 BY MR. McLAUGHLIN:
`19 Q. So Exhibit 1 is the Expert Declaration of
`20 Alexander M. Klibanov Ph.D. Exhibit 2409. And this copy
`21 is from IPR 2021-00881.
`22 Did you submit identical declarations in both
`23 of these matters, Dr. Klibanov?
`24 A. I cannot possibly say they are identical, but I
`25 did submit an expert declaration, and I did provide a
`
`1 that time?
`2 A. Yes, I published another paper that appeared in
`3 2091 -- sorry, 2021, another paper.
`4 Q. Okay. Then if you flip to page 42, it also
`5 appears the last invited presentation is also 2017; is
`6 that correct?
`7 A. Correct.
`8 Q. Have there been any further invited
`9 presentations since that time?
`10 A. No, I have not given any more presentations.
`11 Q. So flipping back to page 24, you said you have
`12 some additional publications since 2017.
`13 A. I did not say that.
`14 Q. I believe you mentioned one or two additional
`15 publications.
`16 A. I mentioned an additional publication.
`17 Q. So there has only been once since 2017?
`18 A. As far as I recall, yes. I published in 2021.
`19 Q. Do you recall the subject matter of that
`20 publication?
`21 A. Yes, and I mean I -- it was a use of our -- the
`22 technology that was developed in my laboratory at MIT for
`23 using antimicrobial materials, and I want to say that it
`24 was for the treatment of an eye disease, but I do not
`25 recall for sure.
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`Page 11
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`Page 13
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`1 copy of my curriculum vitae.
`2 Q. Okay. And on the cover of your declaration you
`3 see there are two case matter numbers there.
`4 A. Yes.
`5 Q. One ends in 880. The other ends in 881.
`6 A. Correct.
`7 Q. Now, if you flip to the back, page 52, is that
`8 your signature?
`9 A. It's a facsimile of my signature, yes.
`10 (Exhibit 2 was marked for identification.)
`11 BY MR. McLAUGHLIN:
`12 Q. Exhibit 2 is the curriculum vitae of Alexander
`13 M. Klibanov, IPR Exhibit No. 2082.
`14 Do you see that?
`15 A. I do see that.
`16 Q. Is this CV up-to-date?
`17 A. It was up-to-date to the best of my ability at
`18 the time when I submitted it.
`19 Q. So if you flip to page 24 --
`20 A. Okay.
`21 Q. -- it appears that the last entry there or the
`22 last few entries, I should say, are publications from
`23 2017.
`24 A. Go ahead, please.
`25 Q. Have there been any further publications since
`
`1 Q. Do you know which eye disease?
`2 A. As I just said, I don't recall for sure.
`3 Q. Do you know if it would have been an angiogenic
`4 eye disorder?
`5 A. As I said, I don't recall for sure.
`6 Q. If you could flip back to Deposition
`7 Exhibit No. 1, this is your declaration from these
`8 matters. And if you could flip to paragraph 21, please.
`9 A. Okay.
`10 Q. Here you set forth Patent Owner's definition of
`11 a person of ordinary skill in the art, correct?
`12 A. Well, I wouldn't put it quite that way.
`13 Q. How would you put it?
`14 A. I mean, there is just a single sentence in this
`15 paragraph 21, which says, "I understand that Patent Owner
`16 contends that the skilled artisan is an ophthalmologist
`17 with experience in treating angiogenic eye disorders,
`18 including through the use of VEGF antagonists." That's
`19 what it says.
`20 Q. You're not a person of ordinary skill in the
`21 art under the Patent Owner's definition, correct?
`22 A. Say it again slowly, please.
`23 Q. You are not a person of ordinary skill in the
`24 art under the Patent Owner's definition, correct?
`25 A. Well, my area of expertise is brought in
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`

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`Page 14
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`1 chemistry, structure by chemistry. That's what my
`2 declaration is about. These are the issues that I
`3 testify on in my declaration.
`4 I'm not a clinician. I have published a number
`5 of papers on treating of eye disease. I have
`6 collaborated with -- collaborated with ophthalmologists
`7 on a number of occasions as evidenced by my publications.
`8 I've reviewed papers, grant proposals in these areas. So
`9 that's my experience specifically in the area of
`10 ophthalmology.
`11 Q. So is that a no? You are not a person of
`12 ordinary skill in the art under the Patent Owner's
`13 definition?
`14 A. I could not answer it with a "yes" or "no,"
`15 because I don't think that it's -- it would be
`16 appropriate. I can repeat what I just said, if you want
`17 me to.
`18 Q. No, no need.
`19 A. Okay.
`20 Q. You are not an ophthalmologist with experience
`21 in treating angiogenic eye disorders, correct?
`22 A. Yes, I am not -- that is correct. Yes. I -- I
`23 probably fall under the person of ordinary skill in the
`24 art definition put forth by petitioner. In fact, I
`25 definitely do. But I'm not a practicing ophthalmologist,
`
`1 Q. Sure. Go ahead. Read that paragraph.
`2 A. Thank you, sir.
`3 Okay. I read that paragraph to myself.
`4 Q. So you're not offering opinions about treatment
`5 and treating an angiogenic eye disorder from the
`6 perspective of an ophthalmologist experienced in treating
`7 angiogenic eye disorders, correct?
`8 A. The opinions that I offer are what is found in
`9 the four corners of my expert declaration. That's what
`10 I'm offering.
`11 Q. And that does not include the perspective of an
`12 ophthalmologist --
`13 MR. COBB: Objection.
`14 BY MR. McLAUGHLIN:
`15 Q. -- with experience in treating angiogenic eye
`16 disorders, correct?
`17 MR. COBB: Objection. Asked and answered.
`18 THE WITNESS: As I said, the opinions I offered
`19 are those that are in my declaration, and I see no reason
`20 for me to characterize them.
`21 BY MR. McLAUGHLIN:
`22 Q. Were you following the development of VEGF
`23 Trap-Eye -- VEGF Trap-Eye as it was going through
`24 clinical trials in the 2008, 2010 time frame?
`25 A. I don't remember. I followed a lot of
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`Page 15
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`1 nor are the issues that I have opined on in my
`2 declaration deal with practicing ophthalmology.
`3 Q. So if you could turn to paragraph 41, please.
`4 A. Okay.
`5 Q. I'm sorry. Page 41 of your declaration.
`6 A. Okay. I'm on page 41.
`7 Q. There is a heading on that page regarding,
`8 "Knowledge of the Amino Acid Sequence of VEGF Trap-Eye
`9 Alone Would Not Necessarily Result in Treatment."
`10 Do you see that?
`11 A. I do see that.
`12 Q. And further down in that first paragraph,
`13 paragraph 90, underneath that heading, you have a phrase
`14 there about treating an angiogenic eye disorder.
`15 A. Mr. McLaughlin, I'd like to establish for the
`16 routine that when you direct my attention to a particular
`17 paragraph, in my declaration, I first would like to read
`18 it to myself, and maybe a little more to orient myself.
`19 And then I'll be happy to entertain your questions. Is
`20 that okay?
`21 Q. For right now I'm just asking you about this
`22 phrase that's in quotes, "treating the angiogenic eye
`23 disorder."
`24 A. I still would like to read the paragraph to
`25 myself.
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`Page 17
`1 scientific developments and have for many years, but I
`2 don't specifically recall.
`3 Q. Do you have experience working with recombinant
`4 VEGF receptor fusion proteins?
`5 A. I have a lot of experience in working with
`6 recombinant proteins, including antibodies. I'm not
`7 specifically sure about VEGF types of proteins.
`8 Q. Have you ever been involved in the development
`9 of a VEGF fusion protein for use as a therapeutic?
`10 A. I don't believe so, but I'm not sure.
`11 Q. Have you ever been involved in the design of a
`12 purification process for a commercial VEGF receptor
`13 fusion protein?
`14 A. I have been involved in designing lot of
`15 purification schemes for pharmaceutical proteins of
`16 different types. But I'm not sure about this particular
`17 type of protein.
`18 Q. So sitting here today, you don't recall having
`19 been involved in the design of a purification process for
`20 commercial VEGF receptor fusion proteins?
`21 A. Mr. McLaughlin, you will have to slow down.
`22 Unless you want me to preface every answer I give you
`23 with the request that you slow down, you may want to
`24 monitor yourself.
`25 Q. Are you having trouble understanding me today,
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`Mylan v. Regeneron, IPR2021-00880
`Page 5
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`1 Dr. Klibanov?
`2 A. You're speaking very fast, and I am having
`3 trouble following what you're asking. I understand it's
`4 only natural for someone who reads questions as you do to
`5 do it fast. But it makes it very difficult to have a
`6 reasonable question-and-answer session.
`7 I'm under oath here, and I take it seriously.
`8 Q. The question was: Have you ever been involved
`9 in the design of a purification process for a commercial
`10 VEGF receptor fusion protein?
`11 A. Not that I recall.
`12 Q. Have you ever been involved in the design of a
`13 manufacturing process for a commercial VEGF receptor
`14 fusion protein?
`15 A. Same answer.
`16 Q. Have you ever been involved in the development
`17 of a formulation of a commercial VEGF receptor fusion
`18 protein?
`19 A. I've been involved in design of formulations of
`20 a lot of pharmaceutical proteins, some of which have
`21 become commercial products, but I'm not sure about the
`22 particular type of proteins that you asked me about.
`23 Q. Have you ever been involved in the development
`24 of an ophthalmologic formulation?
`25 A. Yes, several.
`
`1 A. It's possible, but I don't specifically recall
`2 that.
`3 Q. Do you recall which products that that -- that
`4 that work dealt with?
`5 MR. COBB: Objection. Form.
`6 THE WITNESS: If we're talking about my
`7 academic activities, and I published a number of papers
`8 in this area, as I just said, I'm not sure that they
`9 resulted in any products, although they may have.
`10 If you are talking -- if we are talking about
`11 my consulting and scientific advisory activities, I'm --
`12 I'm not sure.
`13 BY MR. McLAUGHLIN:
`14 Q. So sitting here today, you don't recall if
`15 you've been involved in the development of an
`16 ophthalmologic formulation for intravitreal
`17 administration?
`18 MR. COBB: Objection. Asked and answered.
`19 THE WITNESS: Yeah, I mean I just told you that
`20 I don't recall one way or the other.
`21 BY MR. McLAUGHLIN:
`22 Q. In your expert declaration, Dr. Klibanov, you
`23 don't offer any proposed constructions for any terms in
`24 the '338 patent, correct?
`25 A. My declaration speaks for itself. It says what
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`Page 19
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`Page 21
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`1 Q. And would those be reflected in your CV?
`2 A. Some certainly would be, yes.
`3 Q. Can you point me to the publications that have
`4 to deal with the development of ophthalmic formulations?
`5 A. Sure. So you want me to go through the list of
`6 my publications?
`7 Q. Do you recall off the top of your head which --
`8 which dealt with ophthalmic formulations?
`9 A. No. I have 350 publications. I certainly
`10 don't remember off the top of my head, but I'd be happy
`11 to go over the list and bring your attention to it.
`12 Q. Rather than you doing that, why don't we do
`13 this: Do you recall the general time frame during which
`14 that work take place?
`15 MR. COBB: Objection. Form.
`16 THE WITNESS: I would say that over the last 20
`17 years.
`18 BY MR. McLAUGHLIN:
`19 Q. Over the last 20 years? So beginning 2002?
`20 A. It's -- I'm just giving you my very approximate
`21 estimate. So I would say it is roughly the last 20
`22 years.
`23 Q. Do you know if any of those ophthalmic
`24 formulations were designed for intravitreal
`25 administration?
`
`1 it says.
`2 Q. Is that a no?
`3 A. No, it's not a no. It is that my declaration
`4 speaks for itself. And it says what it says. I don't
`5 remember every word I said in my declaration. If you
`6 would like me to review my declaration with this
`7 particular question in mind, I'll be glad to do it for
`8 you.
`9 Q. Can you turn to the table of contents of your
`10 declaration, please. Do you see the sections there
`11 entitled, "Claim Construction"?
`12 A. I see no such section title in the table of
`13 contents.
`14 Q. If you turn to page 29 of your expert
`15 declaration, here you set forth --
`16 A. Excuse me. We established a routine, right?
`17 So you direct me to a paragraph. I read it to myself.
`18 Then you ask a question. Okay?
`19 Q. Actually, I'm going to ask you a question
`20 before you read it. Okay?
`21 A. Okay.
`22 Q. So paragraph 29 sets forth claim 1 of the '338
`23 patent, correct?
`24 A. If you say so.
`25 Q. Okay. Take a look at claim 1 as you set forth
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`Page 22
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`1 here in your declaration. There is a term in there,
`2 "VEGF antagonist." Do you see that?
`3 A. Let me read the claim of the '338 patent, claim
`4 1 of the '338 patent as it is set forth in my paragraph
`5 29, which is what I offered to do in the first place.
`6 Okay. Could you --
`7 Q. My question goes to the term "VEGF antagonist."
`8 Were you asked to offer a special definition instruction
`9 for that term?
`10 A. If it's not in my expert report -- I'm sorry.
`11 If it is not in my declaration, I don't believe
`12 it is, then I haven't been specifically asked to do it.
`13 So I just assumed the plain and ordinary meaning of that.
`14 Q. Okay. If you flip the page to the last clause
`15 of claim 1 of the '338 patent, do you see that, the one
`16 that begins, "Wherein the VEGF antagonist is --"
`17 A. I do see that clause, yes?
`18 Q. You weren't asked to offer a special
`19 instruction or special definition for that term, were
`20 you?
`21 MR. COBB: Objection.
`22 THE WITNESS: Again, if it is not in my
`23 declaration, then I haven't been asked to set out a
`24 special definition for this claim term.
`25 //
`
`1 "LEGAL STANDARDS."
`2 Do you see that?
`3 A. I do.
`4 Q. You've offered a legal standard for "Burden of
`5 Proof" and for "Anticipation."
`6 Do you see that?
`7 A. I see that there are two subsections,
`8 subsection A, which is entitled, "Burden of Proof"; and
`9 subsection B, which is entitled "Anticipation."
`10 Q. There is no subsection here titled,
`11 "Obviousness," correct?
`12 A. That is correct.
`13 Q. So is it safe to assume you've not been asked
`14 to express an opinion on obviousness with respect to the
`15 claims of the '338 patent and the '069 patent?
`16 A. It's a correct assumption.
`17 (Exhibit 3 was marked for identification.)
`18 BY MR. McLAUGHLIN:
`19 Q. I'm going to hand you what has been marked as
`20 Exhibit 3. So Exhibit 3 is titled, "Declaration of
`21 Alexander M. Klibanov, Ph.D., in Support of Defendants'
`22 Opposition to Amgen's Infringement Motion for Summary
`23 Judgment of Infringement of '422 Claim 1, '933 Claim 3,
`24 and '698 Claim 6."
`25 Do you see that?
`
`Page 23
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`Page 25
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`1 BY MR. McLAUGHLIN:
`2 Q. Then could you turn to paragraph 34, please.
`3 I'm going to ask you the same questions about the '069
`4 patent. Would you like to read that to yourself first?
`5 A. Sure. Thank you.
`6 Yes, sir.
`7 Q. So you were not asked to offer a special
`8 definition of the term "VEGF antagonist" from the -- from
`9 claim 1 of the '069 patent, correct?
`10 A. No. If it is not set out, and I don't believe
`11 it is in my declaration, that means I haven't been asked
`12 to do so.
`13 Q. And the same for the last "Wherein" clause, the
`14 one that begins: "Wherein the VEGF antagonist is," you
`15 were not asked to offer a special definition of that
`16 term, correct?
`17 MR. COBB: Objection. Form.
`18 THE WITNESS: Again, if it's not in my
`19 declaration, I don't believe that it is, then I have not
`20 been asked to do so.
`21 BY MR. McLAUGHLIN:
`22 Q. Can you turn back to page 8 of your
`23 declaration, please.
`24 A. Okay. I'm on page 8.
`25 Q. There is a section on this page entitled,
`
`1 A. I do see that.
`2 Q. This appears to have been submitted to the
`3 United States District Court for the District of
`4 Massachusetts.
`5 Do you see that?
`6 A. That's what the heading says, yes.
`7 Q. And the date on this is June 29th, 2007.
`8 A. To be exact, June 28th, 2007.
`9 Q. Where are you looking?
`10 A. I'm looking at page 73, which is where my
`11 signature is.
`12 Q. So that's the date you signed it, correct?
`13 A. Correct.
`14 Q. Just for clarity, I was reading the docket
`15 stamp at the top of the page that says June 29th, 2007.
`16 A. Okay. I was reading when I actually signed the
`17 declaration.
`18 Q. Now, this was supported -- I mean this was
`19 submitted in support of defendants' opposition to Amgen's
`20 motion, correct?
`21 MR. COBB: Objection. Scope.
`22 THE WITNESS: I mean I -- I don't even recall
`23 that. I vaguely recall that case, but I really don't
`24 remember any -- any details of that.
`25 //
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`888-391-3376
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`Mylan Exhibit 1108
`Mylan v. Regeneron, IPR2021-00880
`Page 7
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`1 BY MR. McLAUGHLIN:
`2 Q. All I'm really asking here is, it says here
`3 that you were -- you submitted this declaration in
`4 support of defendants' opposition. I wanted to confirm
`5 who the defendants were.
`6 So the defendants listed here were F.
`7 Hoffmann-La Roche.
`8 Do you see that?
`9 A. And other companies, yes.
`10 Q. Roche Diagnostics GMPH and Hoffmann-La Roche,
`11 Inc.
`12 Do you see that?
`13 A. I do see that.
`14 Q. But you say you don't recall submitting this on
`15 behalf of Hoffmann-La Roche?
`16 MR. COBB: Objection. Asked and answered.
`17 THE WITNESS: I said nothing of the sort. I
`18 don't remember any details of that case, but I can
`19 certainly read what it says on the first -- on the cover
`20 page.
`21 BY MR. McLAUGHLIN:
`22 Q. Okay. If you could turn back to that signature
`23 page, please, can you confirm that that is your
`24 signature?
`25 A. It obviously is not my signature, but it's
`
`1 ethane. In fact, the molecular structures differ by a
`2 single atom: Ethanol has an additional oxygen atom that
`3 is not present in ethane. The physical and chemical
`4 properties of the substances are nonetheless strikingly
`5 different."
`6 Do you see that?
`7 A. I do not see that. I was waiting until you
`8 finished reading so I can actually read it to myself.
`9 Are you finished reading for the record?
`10 Q. I'm finished.
`11 A. Thank you. Yes, sir.
`12 Q. Do you still agree with your previous testimony
`13 that molecules, at least the molecules with a single
`14 atom, have strikingly different properties?
`15 MR. COBB: Objection. Scope.
`16 THE WITNESS: I still agree with the statement
`17 that ethanol and ethane differ in a single atom, and they
`18 do have strikingly different properties. So I agree with
`19 the statement made there with respect to these two small
`20 molecules.
`21 BY MR. McLAUGHLIN:
`22 Q. This goes beyond those two small molecules,
`23 correct?
`24 MR. COBB: Objection. Form.
`25 THE WITNESS: What is "this"?
`
`Page 27
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`Page 29
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`1 typed there "Alexander M. Klibanov," and that's my name.
`2 Q. Then paragraph 234 says, "I declare under
`3 penalty of perjury under the laws of the United States of
`4 America that the foregoing is true and correct." Did I
`5 read that correctly?
`6 A. Yes, very quickly, but correctly.
`7 Q. Now, if you could turn to paragraph 35 of this
`8 declaration, please.
`9 MR. COBB: What paragraph?
`10 MR. McLAUGHLIN: Paragraph 35.
`11 MR. COBB: Thank you.
`12 THE WITNESS: Okay.
`13 BY MR. McLAUGHLIN:
`14 Q. Now, I'm going to read some statements here.
`15 A. Again, I need to read the paragraph to myself
`16 first.
`17 Q. That's fine. You can go ahead and do that
`18 while I'm reading these into the record. Okay?
`19 A. Okay. Why don't you read it into the record,
`20 and then I will read it to myself, because I don't want
`21 to be distracted when I read.
`22 Q. Okay. So I'm starting where it says, "The
`23 molecular structure," the second sentence of this
`24 paragraph: "The molecular structure of ethanol
`25 (CH3CH2OH) shown below, may seem structurally similar to
`
`1 BY MR. McLAUGHLIN:
`2 Q. This statement.
`3 A. This statement specifically applies to these
`4 two small molecules.
`5 Q. Why don't we read on paragraph 36.
`6 A. Okay.
`7 Q. 36 begins: "This is just one example of the
`8 fundamental principle of organic chemistry that even
`9 seemingly small differences in molecular structure can
`10 and usually do have profound impact on chemical,
`11 physical, and biological properties of a substance."
`12 Do you see that?
`13 A. I would still like to read this paragraph to
`14 myself first before I entertain your questions, sir.
`15 Q. Do you still agree with your previous testimony
`16 that it is a fundamental principle of organic chemistry
`17 that even seemingly small differences in molecular
`18 structure can usually have a profound impact on chemical,
`19 physical, and biological properties of a substance?
`20 A. Yes, I certainly agree with that statement,
`21 yes.
`22 Q. Turn to paragraph 76, please, of this
`23 declaration.
`24 A. Okay. Let me read it to myself.
`25 Q. Go ahead.
`
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`Mylan Exhibit 1108
`Mylan v. Regeneron, IPR2021-00880
`Page 8
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