throbber
Case 2:20-cv-00337-JRG Document 382 Filed 04/13/22 Page 1 of 202 PageID #: 14853
`
`1
`
`SEAGEN, INC.,
`Plaintiff,
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE EASTERN DISTRICT OF TEXAS
`MARSHALL DIVISION
` ( CAUSE NO. 2:20-CV-337-JRG
` )
` (
` )
` (
`
`vs.
` )
` (
`DAIICHI SANKYO CO., LTD.,
` )
` (
`Defendant, and
` )
`ASTRAZENECA PHARMACEUTICALS, (
`LP and ASTRAZENECA UK, LTD., ) MARSHALL, TEXAS
` ( APRIL 7, 2022
` Intervenor-Defendants. ) 8:30 A.M.
`______________________________________________________________
`
`VOLUME 4
`______________________________________________________________
`TRIAL ON THE MERITS
`BEFORE THE HONORABLE RODNEY GILSTRAP
`UNITED STATES CHIEF DISTRICT JUDGE
`and a jury
`______________________________________________________________
`
`SHAWN McROBERTS, RMR, CRR
`100 E. HOUSTON STREET
`MARSHALL, TEXAS 75670
`(903) 923-7464
`shawn_mcroberts@txed.uscourts.gov
`
`Shawn M. McRoberts, RMR, CRR
`Federal Official Court Reporter
`
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`Case 2:20-cv-00337-JRG Document 382 Filed 04/13/22 Page 2 of 202 PageID #: 14854
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`A P P E A R A N C E S
`FOR THE PLAINTIFF: MORRISON & FOERSTER, LLP
` SAN FRANCISCO
` 425 MARKET ST., 32ND FLOOR
` SAN FRANCISCO, CA 94105-2482
` (415) 268-7000
` BY: MR. MICHAEL JACOBS
` MR. MATTHEW CHIVVIS
` MORRISON & FOERSTER, LLP
` PALO ALTO
` 755 PAGE MILL ROAD
` PALO ALTO, CALIFORNIA 94304
` (650) 813-5600
` BY: MR. BRYAN WILSON
` MS. SUMAIYA SHARMEEN
` MR. CHRISTOPHER HAN
` MORRISON & FOERSTER, LLP
` 250 WEST 55TH STREET
` NEW YORK, NEW YORK 10019
` (212) 468-8000
` BY: MR. JAYSON COHEN
` WARD, SMITH & HILL, PLLC
` 1507 BILL OWENS PARKWAY
` LONGVIEW, TX 75604
` (903) 757-6400
` BY: MR. JOHNNY WARD
` MR. WES HILL
` MS. ANDREA FAIR
`FOR THE DEFENDANT: PAUL HASTINGS, LLP - NEW YORK
` 200 PARK AVENUE
` NEW YORK, NY 10166
` (212) 318-6055
` BY: MR. PRESTON RATLIFF, II
` MS. JESSICA STAURING
` THE DACUS FIRM, PC
` 821 ESE LOOP 323, SUITE 430
` TYLER, TX 75701
` (903) 705-1117
` BY: MR. DERON DACUS
`
`Shawn M. McRoberts, RMR, CRR
`Federal Official Court Reporter
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`Case 2:20-cv-00337-JRG Document 382 Filed 04/13/22 Page 3 of 202 PageID #: 14855
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` MANN TINDEL & THOMPSON
` 201 E. HOWARD STREET
` HENDERSON, TX 75654
` (903) 657-8540
` BY: MR. MARK MANN
`FOR THE INTERVENORS: WILLIAMS & CONNOLLY, LLP -
`
` WASHINGTON
` 725 TWELFTH STREET, N.W.
` WASHINGTON, DC 20005-5901
` (202) 434-5000
` BY: MR. DAVID BERL
` MS. JESSAMYN BERNIKER
` MS. JESSICA PAHL
` MS. KATHRYN KAYALI
` MR. TOM FLETCHER
` MR. NICK ROBERTS
` MR. THOMAS FLETCHER
` WILSON ROBERTSON & CORNELIUS
` ONE AMERICAN CENTER
` 909 ESE LOOP 323, SUITE 400
` TYLER, TX 75711-7339
` (903) 509-5000
` BY: MS. JENNIFER AINSWORTH
`OFFICIAL REPORTER: SHAWN M. McROBERTS, RMR, CRR
` 100 E. HOUSTON STREET
` MARSHALL, TEXAS 75670
` (903) 923-8546
`
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`Federal Official Court Reporter
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`Case 2:20-cv-00337-JRG Document 382 Filed 04/13/22 Page 4 of 202 PageID #: 14856
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`INDEX
`
`EXAMINATION
`Page
`Witness Name
`JOHN LAMBERT, PhD
`Redirect By MR. RATLIFF ......................................... 12
`Recross By MR. CHIVVIS .......................................... 19
`PATRICK BURKE, PhD
`Direct By BY DEPOSITION ......................................... 28
`NAOMI KO, M.D., M.P.H
`Direct By MS. BERNIKER .......................................... 37
`Cross By MR. HILL ............................................... 55
`BRIAN TOKI, PhD
`BY DEPOSITION ................................................... 61
`SVETLANA DORONINA, PhD
`BY DEPOSITION ................................................... 66
`TONI KLINE
`BY DEPOSITION ................................................... 78
`CAROLYN BERTOZZI, PhD
`Direct By MR. CHIVVIS ........................................... 87
`Recross By MR. RATLIFF .......................................... 115
`Redirect By MR. CHIVVIS ......................................... 131
`Recross By MR. RATLIFF .......................................... 133
`CARRIE DISTLER
`Direct By MR. WILSON ............................................ 138
`Cross By MR. DACUS .............................................. 185
`Redirect By MR. WILSON .......................................... 232
`TODD EDWIN SIMPSON
`BY DEPOSITION ................................................... 239
`CHRISTINE MEYER, PhD
`Direct By MR. DACUS ............................................. 255
`Cross By MR. WILSON ............................................. 286
`Redirect By MR. DACUS ........................................... 305
`
`Shawn M. McRoberts, RMR, CRR
`Federal Official Court Reporter
`
`

`

`Case 2:20-cv-00337-JRG Document 382 Filed 04/13/22 Page 5 of 202 PageID #: 14857
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`THE COURT: Be seated, please.
`Counsel, as you're aware, during the final portion of
`yesterday's segment of the trial, Juror No. 4 became
`nauseated. We took a recess, and then we recessed for the day
`about an hour earlier than we might otherwise have because of
`that.
`She's indicated to the deputy in charge that she's been
`equally nauseated and feeling bad all night long, and,
`consequently, I'm going to excuse her and we're going to go
`forward with our six remaining jurors. And I'll advise the
`jury of that once they come into the courtroom so they'll know
`why their cohort is not with them.
`All right. Are the parties prepared to read into the
`record those items on the list of preadmitted exhibits used
`during yesterday's portion of the trial?
`MS. STAURING: Yes, Your Honor.
`THE COURT: Please proceed.
`MS. STAURING: Good morning, Your Honor. Jessica
`Stauring on behalf of Defendants.
`MR. HAN: Chris Han on behalf of Plaintiffs.
`THE COURT: Good morning. Please go ahead.
`MS. STAURING: The parties have agreed to read the
`following exhibits into the record. The following exhibits
`are all: PX, 30, 155, 164, 169, 170, 260, 261, 263, 299, and
`843.
`
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`Case 2:20-cv-00337-JRG Document 382 Filed 04/13/22 Page 6 of 202 PageID #: 14858
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`The following exhibits are all DX: 3, 4, 5, 6, 7, 8, 9,
`10, 11, 12, 13, 14, 15, 16, 57, 58, 59, 60, 61, 62, 64, 69,
`70, 71, 74, 75, 77, 78, 79, 82, 83, 85, 86, 88, 89, 92, 93,
`96, 107, 108, 110, 112, 114, 115, 118, 123, 124, 125, 126,
`127, 128, 129, 134, 136, 140, 142, 145, 153, 155, 157, 158,
`159, 161, 163, 164, 166, 167, 168, 169, 172, 173, 176, 177,
`179, 180, 181, 183, 185, 186, 190, 191, 195, 199, 202, 205,
`208, 213, 214, 215, 216, 217, 218, 219, 220, 221, 223, 225,
`226, 233, 235, 236, 237, 242, 243, 244, 246, 247, 250, 251,
`252, 281, 461, 495, 538, 571, 691, 692, 693, 940, and 941.
`That's all, Your Honor.
`THE COURT: Any objection to that rendition from the
`opposing party?
`MR. HAN: No, Your Honor.
`THE COURT: Is there anything else to read into the
`record from yesterday, counsel?
`MR. HAN: Nothing further, Your Honor.
`THE COURT: Thank you very much.
`MS. STAURING: Thank you.
`THE COURT: Ms. Ainsworth, I was told by your
`co-counsel that you have an additional proffer you wanted to
`make?
`
`MS. AINSWORTH: Yes, Your Honor, if I may.
`THE COURT: Please proceed. I'd like to get started
`with the jury as soon as possible.
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`Case 2:20-cv-00337-JRG Document 382 Filed 04/13/22 Page 7 of 202 PageID #: 14859
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`MS. AINSWORTH: Yes, Your Honor.
`Your Honor, Defendants earlier yesterday
`offered -- requested to be able to present certain deposition
`testimony of Seagen's corporate representative, Dr. Peter
`Senter, on certain key issues in the case, and requested that
`that corporate representative testimony be played during
`Defendant's case in chief. This was after Doctor Senter had
`testified live in the Plaintiff's case in chief.
`The Court ruled that Defendants should not present this
`30(b)(6) deposition testimony in our case due to potential
`jury confusion, and the Court offered Defendants the
`opportunity to examine him live rather than present the
`deposition testimony.
`And Defendants just respectfully state that we should be
`allowed to offer the 30(b)(6) deposition testimony for two
`reasons: First, under Rule 32(a)(2) and (3), the corporate
`representative testimony is usable for any purpose without
`regard to the witness' availability; and, second, because his
`testimony during the Plaintiff's case in chief was in his
`individual capacity rather than a corporate representative.
`He was not presented in this case as Seagen's corporate
`representative. Instead, they've had an individual
`representative at trial which is their -- at counsel table
`which is their right.
`However, we should have the right to present this
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`Case 2:20-cv-00337-JRG Document 382 Filed 04/13/22 Page 8 of 202 PageID #: 14860
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`corporate testimony of Seagen through that deposition rather
`than having to re-examine him again in his individual
`capacity. And we have the deposition cuts. I will have the
`physical copies that I can tender to the Court on the next
`break.
`
`THE COURT: Does that complete your proffer?
`MS. AINSWORTH: It does, Your Honor.
`THE COURT: Let me just add for optional
`completeness, the Court did not preclude the Defendants from
`presenting Doctor Senter in their case in chief. The Court
`merely advised the parties that, in the Court's view, it would
`create unnecessary confusion with the jury since Doctor Senter
`testified live in the Plaintiff's case and Doctor Senter has
`personally been present in the courtroom throughout the trial
`and is present sitting in the courtroom right now.
`The Court observed that there would be no problem with
`the same questions and answers set forth in his deposition
`being asked to him live so that the same testimony could be
`presented and it could be clearly made clear to the jury that
`that testimony was in a different capacity.
`It was not a matter of whether he could -- or whether
`that testimony could or could not be presented, but merely the
`form of presentation because the Court in the early portion of
`the trial in its preliminary instructions to the jury made it
`clear in explaining what a deposition was, that depositions
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`were presented when people could not be present to testify
`live.
`And the Court, exercising one of its paramount
`obligations to prevent unnecessary confusion with the jury,
`merely indicated to the Defendant that if they chose to call
`Doctor Senter in their case in chief, the Court preferred and
`would direct that they do it with him personally on the
`witness stand, asking the same questions and seeking the same
`information that they otherwise purported to play by
`deposition clips.
`And that's my view of the interplay that took place. I
`accept your proffer, and we'll go from there.
`MS. AINSWORTH: Thank you, Your Honor.
`THE COURT: All right. Is there anything from
`Plaintiff?
`MR. HILL: Your Honor, you stated the basis for the
`Court's exclusion. I'm happy to state our position with
`regard for the record if the Court wants to hear it.
`THE COURT: I just generally asked if you had
`anything else before I brought in the jury. If you would like
`to respond to the proffer, you may.
`MR. HILL: Thank you, Your Honor.
`THE COURT: It's your option.
`MR. HILL: Thank you, Your Honor.
`I will state one additional issue. Under Rule 611,
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`obviously the Court has the discretion to do exactly what it
`did. The material that was going to be offered was cumulative
`of testimony that had already been elicited live from Doctor
`Senter. Defendants elected not to recall him live.
`And as the Fifth Circuit recognized Brazos River
`Authorities versus GE Ionics, district courts are reluctant to
`allow the reading into evidence of a Rule 30(b)(6) deposition
`if a witness is available to testify at trial. That is
`precisely the situation we had here, the Fifth Circuit has
`said the Court is perfectly within its discretion to do what
`it did, and we'd like that noted for the record.
`THE COURT: And just to avoid any doubt in the
`record, I am looking at Doctor Senter physically sitting in
`the courtroom where he has been present throughout the
`entirety of the trial.
`All right. Is there anything else we need to take up
`before we bring in the jury?
`MR. HILL: No, Your Honor.
`MR. DACUS: No, Your Honor.
`THE COURT: All right. Mr. Ratliff, you may go to
`the podium and prepare for your redirect.
`Doctor Lambert, if you'll come forward and return to the
`witness stand, sir. As I know you're aware, let me remind you
`you're under oath.
`THE WITNESS: Yes. Thank you, Your Honor.
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`THE COURT: You have something, Mr. Chivvis, or are
`you just getting up for the jury?
`MR. CHIVVIS: I'm just getting up for the jury so
`I'm not scrambling.
`THE COURT: All right. While they're getting
`situated, bring in the jury, please, Mr. Johnston.
`(Whereupon, the jury entered the courtroom.)
`THE COURT: Good morning, ladies and gentlemen.
`Welcome back. Please have a seat.
`Members of the jury, as you're well aware, you are now
`down to six from seven. Miss Gabel, No. 4, as you are aware,
`experienced some nausea yesterday toward the end of the day.
`We stopped a little bit early because of that. I understand
`she is substantially the same overnight.
`We can proceed without seven jurors. Six is an adequate
`number to return a verdict, but it's necessary to have six
`jurors. Given those circumstances, I've excused Miss Gabel,
`and you six will go forward as the jury in the case. I just
`want you to be aware of that so there's no question about why
`you're missing one of your members who was here yesterday.
`All right. We'll return to the testimony of Dr. John
`Lambert. When we ended yesterday's portion of the trial,
`Defendants were about to engage in redirect examination of the
`witness, and that's where we'll pick up with Mr. Ratliff.
`You may proceed, counsel.
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`Case 2:20-cv-00337-JRG Document 382 Filed 04/13/22 Page 12 of 202 PageID #: 14864
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`MR. RATLIFF: Thank you, Your Honor.
`JOHN LAMBERT, PhD., PREVIOUSLY SWORN,
`REDIRECT EXAMINATION
`
`BY MR. RATLIFF:
`Q.
`Good morning, Doctor Lambert.
`A.
`Good morning, counsel.
`Q.
`Doctor Lambert, do you recall yesterday that Seagen's
`counsel asked you whether the claims of the '039 Patent used
`the word 'only' in connection with the G and F tetrapeptide
`limitation?
`A.
`I do recall that.
`Q.
`Well, let's bring up DX 1 and let's turn to the last page
`which shows the claims.
`Now, focusing on claim 1, Doctor Lambert, can you tell us
`whether the claim requires that each amino acid in the
`tetrapeptide is either G or F?
`A.
`Yes, it does.
`Q.
`And, Doctor Lambert, what's the significance of what you
`just told us as to the question regarding whether the claim
`requires a G/F-only tetrapeptide?
`A.
`The claim requires a G/F-only tetrapeptide.
`Q.
`Now, let's bring up one of your slides, slide 94.
`Doctor Lambert, yesterday Seagen's counsel pointed you to
`Seagen's original 2004 application and asked about G and F and
`whether they were listed among many other amino acids. Do you
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`Case 2:20-cv-00337-JRG Document 382 Filed 04/13/22 Page 13 of 202 PageID #: 14865
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`recall that?
`A.
`I do recall that.
`Q.
`Now, did Seagen's counsel point you to any disclosure in
`that original 2004 application that showed a tetrapeptide
`where each amino acid must be G or F?
`A.
`No.
`Q.
`Now, Doctor Lambert, let's bring up DX 104 -- or slide
`104.
`
`Now, Doctor Lambert, in slide 104, do you recall that you
`were asked a question by Seagen's counsel and the question
`related -- do you recall that the question related to when did
`Seagen first file patent claims to an ADC with a G/F-only
`tetrapeptide?
`A.
`Yes, I recall that.
`Q.
`And does this slide refresh your recollection as to when
`that happened?
`A.
`It does.
`Q.
`And can you tell us when that happened, sir?
`A.
`In July 2019.
`Q.
`Now, Doctor Lambert, and do you recall that you were
`asked questions about Seagen's 2004 original application by
`counsel?
`A.
`I do.
`Q.
`And did that 2004 application ultimately publish and be
`issued as a patent?
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`Case 2:20-cv-00337-JRG Document 382 Filed 04/13/22 Page 14 of 202 PageID #: 14866
`14
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`Yes.
`A.
`Now, Doctor Lambert, do you recall yesterday that
`Q.
`Seagen's counsel pointed you to the sequence GFLG that's one
`of the three examples of the tetrapeptides in the '039 Patent?
`A.
`Yes, I recall that.
`Q.
`Now, Doctor Lambert, is that sequence a G/F-only
`tetrapeptide?
`A.
`No, it is not.
`Q.
`And does the original 2004 application by Seagen include
`any example of an ADC with a GFLG tetrapeptide?
`A.
`No, it does not.
`Q.
`Now, do you recall that Doctor Bertozzi also testified
`that a skilled person would have started with a GFLG in the
`2004 application and modified it to arrive at a G/F-only
`tetrapeptide?
`A.
`I do remember that.
`Q.
`And, Doctor Lambert, can you tell us whether or not you
`believe the skilled person in 2004 would have made that
`modification as Doctor Bertozzi suggests?
`A.
`No, I don't believe a skilled person would do that.
`Q.
`And can you explain to us why, Doctor?
`A.
`Well, the -- that GFLG tetrapeptide is one of two that
`were listed in the Dubowchik paper that actually goes on to
`describe dipeptides as being optimal at that time for
`delivering a payload -- a drug moiety with a peptide cleavable
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`Case 2:20-cv-00337-JRG Document 382 Filed 04/13/22 Page 15 of 202 PageID #: 14867
`15
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`linker, in particular the Val Cit dipeptide that is in all of
`Seagen's current cleavable approved products.
`Q.
`And, Doctor Lambert, can you tell for us you mentioned a
`Dubowchik paper, is that Dubowchik paper -- did that come
`before or after Seagen's 2004 application?
`MR. CHIVVIS: Objection, Your Honor. This is
`outside the scope of cross.
`THE COURT: Overruled.
`THE WITNESS: It came before.
`(BY MR. RATLIFF) Now, let's bring up PDX 3.29. This is
`Q.
`one of Doctor Bertozzi's slides.
`Now, Doctor Lambert, do you recall testifying yesterday
`about a page from Doctor Kline's laboratory notebook that
`purportedly demonstrates that she made GSVQ, a tetrapeptide?
`A.
`I do recall that.
`Q.
`Now, let's turn to DX 1, which is the patent-in-suit, and
`turn our attention to column 68. And let's look at lines 8
`through 9.
`And, Doctor Lambert, do you see the GSVG tetrapeptide
`
`here?
`Yes. The glycine serene valine glutamine in the
`A.
`one-letter code is GSVQ.
`Q.
`And do you see that sequence is in the patent?
`A.
`I do see that it's in the patent.
`Q.
`And is that sequence a G/F-only tetrapeptide?
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`Case 2:20-cv-00337-JRG Document 382 Filed 04/13/22 Page 16 of 202 PageID #: 14868
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`No, it is not.
`A.
`Does Seagen's patent provide any example of an ADC made
`Q.
`using this tetrapeptide?
`A.
`No, it does not.
`Q.
`And is there any teaching in Seagen's patent showing a
`modification of this tetrapeptide to be used in an ADC as
`Doctor Bertozzi suggests?
`A.
`No, there is not.
`Q.
`Now, Doctor Lambert, let's bring up your slide 96.
`And, Doctor Lambert, do you recall yesterday that
`Seagen's counsel asked you whether you agreed that you could
`have made G/F-only tetrapeptides very quickly in the lab?
`A.
`I do recall him asking that.
`Q.
`And do you recall that you answered you could if you knew
`that you had to make them?
`A.
`I do recall my answer, yes.
`Q.
`And can you explain to us what you meant by that
`response?
`A.
`Yes, because from the instructions in the patent, if one
`knew one had to make a tetrapeptide, there are 83 possible
`building blocks to make that tetrapeptide, and you would end
`up with 147 million alternatives.
`So there are no blazemarks, as was the term used, to
`guide you to decide that a tetrapeptide containing glycine and
`phenylalanine only were the ones to make and try.
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`Case 2:20-cv-00337-JRG Document 382 Filed 04/13/22 Page 17 of 202 PageID #: 14869
`17
`
`Q.
`
`Thank you, Doctor.
`Now let's bring up your slide 41.
`Doctor, do any of the questions or your answers on
`cross-examination cause you to change your opinion that
`Enhertu does not infringe Seagen's patent?
`A.
`Yes.
`Q.
`Let me ask the question again.
`A.
`Okay.
`Q.
`Doctor, do any of the questions or your answers on
`cross-examination cause you to change your opinion that
`Enhertu does not infringe Seagen's patent?
`A.
`Sorry. I was confused by the double negative. No.
`Q.
`And do any of the questions or answers on
`cross-examination cause you to change your opinion that
`Seagen's patent claims are invalid?
`A.
`No.
`Q.
`Now, let's highlight this first bullet.
`Now, on this first issue on your slide, if the jury
`agrees with your analysis that Seagen's patent is really about
`auristatin drugs, what finding do you believe the jury should
`reach?
`A.
`That the patent is invalid because the claim is not
`restricted to auristatin drugs.
`Q.
`Now, let's highlight the second bullet on your slide.
`Now, on this second issue, if the jury agrees with your
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`Case 2:20-cv-00337-JRG Document 382 Filed 04/13/22 Page 18 of 202 PageID #: 14870
`18
`
`analysis that Seagen's patent is really about auristatin drugs
`and does not teach how to make G/F-only tetrapeptide ADCs with
`any and all possible drugs, what finding do you believe the
`jury should reach?
`A.
`I believe the jury should reach the finding that the
`patent is invalid.
`Q.
`Now, let's highlight the third bullet.
`On this third issue on your slide, which says, "lacks
`priority, so it is anticipated," can you tell us whether our
`U.S. patent system seeks to reward those who conceive of and
`possess the invention first?
`A.
`Yes, it does.
`Q.
`And based on all of the evidence presented to the jury,
`which party in this lawsuit came up with a G/F-only
`tetrapeptide ADC first?
`A.
`Daiichi Sankyo.
`Q.
`And based on the testimony of Doctor Senter and the other
`Seagen scientists presented to the jury, which party in this
`lawsuit came up with a G/F-only targeted ADC first?
`A.
`Daiichi Sankyo were the first to do that anywhere.
`Q.
`Now -- and if the jury agrees with your analysis of those
`facts, what finding do you believe the jury should reach?
`A.
`That the patent is invalid.
`Q.
`Now, Doctor, based upon all of your analysis and what has
`been presented to the jury, do you believe that Seagen's 2019
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`Case 2:20-cv-00337-JRG Document 382 Filed 04/13/22 Page 19 of 202 PageID #: 14871
`19
`
`filed patent actually claims what the named inventors regarded
`as their invention?
`A.
`I can only go by what's in the 200 pages of the
`disclosure, and what is new in all of those 200 pages were
`monomethylvaline compounds. So my opinion is based on the
`reading of all of the -- the whole document, and I would say
`that what they invented was monomethylvaline compounds.
`Q.
`And, Doctor Lambert, based upon all of information that
`you have heard, do you know whether or not the Patent Office
`heard all the information presented here in these few days?
`A.
`I can't answer if they heard all of the information
`presented in these few days.
`MR. RATLIFF: I pass the witness, Your Honor.
`THE COURT: All right. Is there additional
`cross-examination by the Plaintiff?
`MR. CHIVVIS: Yes, Your Honor. Just a few
`questions.
`THE COURT: All right. Let's proceed with
`additional cross-examination by the Plaintiff.
`MR. CHIVVIS: Thank you, Your Honor.
`RECROSS EXAMINATION
`
`BY MR. CHIVVIS:
`Q.
`Doctor, I'd like to start with the demonstrative that we
`looked at yesterday. You recognize what I've marked as PDX
`3.55A?
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`Case 2:20-cv-00337-JRG Document 382 Filed 04/13/22 Page 20 of 202 PageID #: 14872
`20
`
`I do recognize it.
`A.
`And this is the demonstrative where we walked through
`Q.
`each of the elements of claim 1 and you agreed with me that
`for the first one, two, three, four, five, six, seven
`elements, that they were all satisfied. Correct?
`A.
`I agreed with the questions as you asked them.
`Q.
`Which was that these limitations of the claim are each
`met by Enhertu. Correct?
`A.
`As you asked the questions, the answer was yes.
`Q.
`And we circled two aspects of the very last
`element--intracellularly cleaved and free drug. Right?
`A.
`We did.
`Q.
`And we went over FDA documents that showed that those
`terms were used by Daiichi Sankyo in explaining what Enhertu
`is and what it does to the FDA. Right?
`A.
`Yes.
`Q.
`Do you agree with me that for purposes of infringement,
`the issue is whether each one of these limitations is met, and
`if all the limitations of claim 1 are met, then claim 1 is
`infringed and the patent is, therefore, infringed? Correct?
`A.
`If all the limitations of claim 1 are met, the patent is
`infringed.
`Q.
`And, Doctor, that's irrespective of your validity
`arguments about whether certain items were proprietary to
`Seagen or known or established in the earlier disclosure.
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`Case 2:20-cv-00337-JRG Document 382 Filed 04/13/22 Page 21 of 202 PageID #: 14873
`21
`
`Correct? The issue of infringement is separate from validity.
`Right?
`A.
`It is.
`Q.
`So all those red X marks that opposing counsel was
`putting through the slide did not have to do with
`infringement. Correct?
`A.
`I'm not -- I think I disagree with that assertion, but
`my --
`Q.
`Doctor Lambert, is it your position that whether an item
`is confidential information to Seagen has to bear on whether
`there's infringement of the antibody limitation?
`A.
`That's not what I said.
`Q.
`Okay. So when counsel was asking you with each of these
`elements whether it was proprietary to Seagen, that had
`no -- that has no bearing on the issue of infringement in this
`case, does it?
`A.
`He was asking questions in a different way than you put
`them, and there the answers were that the claims were not met.
`Q.
`I'm going to ask you just straight. Let's put aside the
`way counsel asked you. Whether or not any of these elements
`in your view are proprietary to Seagen or not has no bearing
`on infringement in this case. Isn't that true?
`A.
`Yes.
`Q.
`Doctor, I'd like to turn to -- actually before I turn to
`this slide, Doctor, in your testimony this morning, I think
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`Case 2:20-cv-00337-JRG Document 382 Filed 04/13/22 Page 22 of 202 PageID #: 14874
`22
`
`you were trying to correct an issue that arose yesterday with
`respect to Doctor Kline's laboratory notebooks.
`Doctor, do you recall analyzing that GSVQ sequence from
`Doctor Kline's notebooks?
`A.
`I recall the slide that had it on, yes.
`Q.
`And yesterday you targeted that Doctor Kline's
`tetrapeptides didn't make it into the '039 Patent. Isn't that
`true?
`I may have said that, but I was clearly wrong.
`A.
`Because, in fact, she does have her tetrapeptide from her
`Q.
`laboratory notebook right in the '039 Patent. Right?
`A.
`That's true. But there's no evidence that an ADC was
`made with it.
`Q.
`Doctor, you agree with me that Doctor Kline's
`tetrapeptide from her laboratory notebook appears in the '039
`Patent. Right?
`A.
`Yes, plainly does.
`Q.
`And you agree with me that Doctor Kline's tetrapeptide
`appears in the 2004 original application that was filed.
`A.
`Yes.
`Q.
`Now, let's go to slide 3.28 of Doctor Bertozzi.
`You testified that none of the information on this slide
`made it into the '039 Patent, but that's not true either, is
`it?
`A.
`
`Well, they do reproduce the Val Cit at the bottom.
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`Case 2:20-cv-00337-JRG Document 382 Filed 04/13/22 Page 23 of 202 PageID #: 14875
`23
`
`And it's more than just that, isn't it?
`Q.
`There is the phe lys, the two dipeptides that were in the
`A.
`prior art discovered by Bristol Myers Squibb.
`Q.
`And it's more than that, isn't it?
`A.
`I'm not sure about that.
`Q.
`You just don't know?
`A.
`Without looking at -- I'm pretty sure they're not there,
`but I would have to look at this list side by side with the
`'039 Patent again.
`Q.
`And you didn't prepare or conduct an extensive analysis
`of every single one of these marching through to see whether
`they were in the '039 Patent, did you?
`A.
`I did as thorough analysis as I could. And apart from
`the two dipeptides you point out that were in the prior art
`already even before the 2004 filing, I'm pretty sure that none
`of these appear as dipeptides in the patent.
`Q.
`So let's be clear. The only ones you agree are in the
`'039 Patent are Val Cit?
`A.
`That's Val Cit.
`Q.
`And which other one?
`A.
`You go up one, two, three -- four up from the bottom.
`Q.
`The h phe lys?
`A.
`I'm not sure what h stands for in this context.
`Q.
`Well, isn't that h important? Isn't that different than
`phe lys without the h?
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`Case 2:20-cv-00337-JRG Document 382 Filed 04/13/22 Page 24 of 202 PageID #: 14876
`24
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`I don't know what the h stands for.
`A.
`You are an expert in this field, aren't you?
`Q.
`I have never seen phe with a small h in front of it.
`A.
`All right. Well, I'd like to circle another one here as
`Q.
`well. What about Ava? Do you know what Ava is?
`MR. CHIVVIS: Mr. Lee, your notations are better
`
`than mine.
`Q.
`(BY MR. CHIVVIS) Do you know what Ava is?
`A.
`No. I can guess, but I don't know.
`Q.
`What's your guess?
`MR. RATLIFF: Objection, calls for speculation.
`MR. CHIVVIS: He is an expert.
`THE COURT: He is an expert. This is his opinion.
`He's not speculating about anybody else. I'll overrule the
`objection.
`
`THE WITNESS: Ava, A-V-A, to my knowledge is not an
`approved -- is not a regular amino acid, for example, like
`gly, for glycine. So I don't know what Doctor Kline means by
`that.
`(BY MR. CHIVVIS) Well, what is it in your view? How
`Q.
`have you heard it referred to?
`A.
`I don't know because, I mean, I can assume that
`it's -- if V is Val and A is Ala, it may be that, but I don't
`know.
`Q.
`
`All right. Let's look at the '039 Patent and see if the
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`Case 2:20-cv-00337-JRG Document 382 Filed 04/13/22 Page 25 of 202 PageID #: 14877
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`research from that Research Day presentation

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