In The Matter Of:
`
`(cid:7)(cid:14)(cid:11)(cid:561)(cid:14)(cid:11)(cid:14)(cid:14)(cid:27)(cid:561)(cid:3)(cid:16)(cid:6)(cid:561)(cid:5)(cid:17)(cid:15)(cid:18)(cid:3)(cid:16)(cid:27)(cid:496)(cid:561)(cid:138)(cid:151)(cid:141)(cid:561)(cid:11)(cid:15)(cid:5)(cid:14)(cid:17)(cid:16)(cid:7)(cid:561)(cid:21)(cid:27)(cid:21)(cid:22)(cid:7)(cid:15)(cid:21)(cid:561)
`(cid:14)(cid:14)(cid:5)
`(cid:159)(cid:495)
`(cid:9)(cid:7)(cid:16)(cid:7)(cid:16)(cid:22)(cid:7)(cid:5)(cid:10)(cid:496)(cid:561)(cid:11)(cid:16)(cid:5)(cid:495)(cid:561)(cid:138)(cid:151)(cid:141)(cid:561)(cid:5)(cid:11)(cid:22)(cid:27)(cid:561)(cid:17)(cid:8)(cid:561)(cid:10)(cid:17)(cid:18)(cid:7)
`
`(cid:561)(cid:561)(cid:527)(cid:527)(cid:527)(cid:527)(cid:527)(cid:527)(cid:527)(cid:527)(cid:527)(cid:527)(cid:527)(cid:527)(cid:527)(cid:527)(cid:527)(cid:527)(cid:527)(cid:527)(cid:527)(cid:527)(cid:527)(cid:527)(cid:527)(cid:527)(cid:527)(cid:527)(cid:527)(cid:527)(cid:527)(cid:527)(cid:527)(cid:527)(cid:527)(cid:527)(cid:527)(cid:527)(cid:527)(cid:527)(cid:527)(cid:527)(cid:527)(cid:527)(cid:527)(cid:527)(cid:527)(cid:527)(cid:527)(cid:527)(cid:527)(cid:527)(cid:527)
`
`(cid:21)(cid:11)(cid:20)(cid:561)(cid:9)(cid:20)(cid:7)(cid:9)(cid:17)(cid:20)(cid:27)(cid:561)(cid:25)(cid:11)(cid:16)(cid:22)(cid:7)(cid:20)(cid:561)(cid:556)(cid:561)(cid:24)(cid:152)(cid:149)(cid:495)(cid:561)(cid:343)
`(cid:12)(cid:138)(cid:151)(cid:158)(cid:138)(cid:155)(cid:162)(cid:561)(cid:343)(cid:351)(cid:496)(cid:561)(cid:344)(cid:342)(cid:343)(cid:347)
`
`(cid:561)(cid:561)(cid:527)(cid:527)(cid:527)(cid:527)(cid:527)(cid:527)(cid:527)(cid:527)(cid:527)(cid:527)(cid:527)(cid:527)(cid:527)(cid:527)(cid:527)(cid:527)(cid:527)(cid:527)(cid:527)(cid:527)(cid:527)(cid:527)(cid:527)(cid:527)(cid:527)(cid:527)(cid:527)(cid:527)(cid:527)(cid:527)(cid:527)(cid:527)(cid:527)(cid:527)(cid:527)(cid:527)(cid:527)(cid:527)(cid:527)(cid:527)(cid:527)(cid:527)(cid:527)(cid:527)(cid:527)(cid:527)(cid:527)(cid:527)(cid:527)(cid:527)(cid:527)
`(cid:561)(cid:561)(cid:561)(cid:561)(cid:561)(cid:561)(cid:561)(cid:561)(cid:561)(cid:561)(cid:561)(cid:561)(cid:561)(cid:561)(cid:561)(cid:561)(cid:561)(cid:561)(cid:561)(cid:561)(cid:561)(cid:561)(cid:561)(cid:561)(cid:561)(cid:561)(cid:561)(cid:561)(cid:561)(cid:561)(cid:561)(cid:561)(cid:561)(cid:561)(cid:561)(cid:561)(cid:561)(cid:561)(cid:561)(cid:561)(cid:561)(cid:561)(cid:561)(cid:561)(cid:561)(cid:561)(cid:561)(cid:561)(cid:561)(cid:561)(cid:561)(cid:561)(cid:561)(cid:561)(cid:561)(cid:561)(cid:561)(cid:561)(cid:561)(cid:561)(cid:561)(cid:561)(cid:561)(cid:561)(cid:561)(cid:561)(cid:561)(cid:561)(cid:561)(cid:561)(cid:561)(cid:561)(cid:561)(cid:561)(cid:561)(cid:561)(cid:561)(cid:561)(cid:561)
`
`Mylan v. Genentech
`IPR2016-00710
`Genentech Exhibit 2024
`
`

`
`Page 1
`
` UNITED STATES DISTRICT COURT
` CENTRAL DISTRICT OF CALIFORNIA
`
`- - - - - - - - - - - - - - - - -
` )
`ELI LILLY AND COMPANY, and )
`IMCLONE SYSTEMS LLC, )
` Plaintiffs, )
` )Case Nos.:
`v. )2:13-cv-07248-MRP-JEMx
` )2:13-cv-05400-MRP-JEMx
`GENENTECH, INC. and )
`CITY OF HOPE, )
` Defendants. )
`- - - - - - - - - - - - - - - - -
`
` VIDEOTAPED DEPOSITION OF SIR GREGORY WINTER
` VOLUME I
` Monday, January 19, 2015
` Commencing: 10:05 a.m.
` Taken at:
` Master's Lodge, Trinity College
` Trinity Street
` Cambridge,
` London, CB2 1TQ
` United Kingdom
`
`Court Reporter:
`Mrs. Chanelle Malliff
`Accredited Real-time Reporter
`
`

`
`SIR GREGORY WINTER - 1/19/2015
`
`Page 2
`
`Page 4
`
`1 P R O C E E D I N G S
`2 THE VIDEOGRAPHER: This is the video operator,
`3 Wendy Viner, of Merrill Legal Solutions. Today's date is
`4 January 19, 2015 and the time is 10:05 a.m. We're at
`5 Trinity College, Cambridge, U.K., to take the videotaped
`6 deposition of Sir Gregory Winter in the matter of Eli Lilly
`7 & Company et al versus Genentech and City of Hope, case
`8 number 2:13-cv-07248-MRP-JEMx.
`9 The court reporter today is Chanelle Malliff of
`10 Merrill Legal Solutions. Would the court reporter please
`11 swear in the witness.
`12 SIR GREGORY WINTER
`13 having been sworn testified as follows:
`14 THE VIDEOGRAPHER: Would counsel please identify
`15 themselves and state whom they represent and we can proceed.
`16 MS. DURIE: Daralyn Durie, representing Genentech.
`17 MR. BRAUSA: Adam Brausa, representing Genentech.
`18 MS. HELM: Katherine Helm, representing Eli Lilly.
`19 MR. SCHWARTZ: Robert Schwartz, representing
`20 Eli Lilly, and with me are my colleagues Brendan O'Malley.
`21 And from Lilly, Mark Stewart.
`22 THE VIDEOGRAPHER: Thank you. Please proceed.
`23 EXAMINATION BY MS. DURIE:
`24 Q. Good morning.
`25 A. Good morning.
`
`Page 3
`
`Page 5
`
`1 Q. How would you like me to address you this morning?
`2 A. You can call me Greg.
`3 Q. Very good.
`4 A. If you get nasty you can call me Sir Gregory.
`5 Q. You have expressed certain opinions in this case
`6 regarding the Cabilly family of patents; is that right?
`7 A. That's right.
`8 Q. And one of the opinions that you have expressed
`9 concerns the written description requirement?
`10 A. Yep.
`11 Q. What is your understanding of the written
`12 description requirement?
`13 A. So my understanding was put down in my deposition
`14 but essentially my understanding is that the written
`15 description should be sufficient to guide somebody to be
`16 able to do the work described in it.
`17 Q. You've also expressed opinions in this case
`18 regarding the enablement requirement; is that right?
`19 A. That's correct.
`20 Q. What do you understand the difference to be between
`21 the written description requirement and the enablement
`22 requirement, if any?
`23 MS. HELM: Objection: calls for a legal
`24 conclusion.
`25 A. I had taken them to be very similar but what
`
`2 (Pages 2 to 5)
`
`1 A P P E A R A N C E S
`2
`
`Appearing for Eli Lilly and Co. and the Witness:
`
`3
`
` SIMPSON THACHER & BARTLETT LLP
`4 425 Lexington Avenue
` New York, NY 10017-3954
`5 By: Katherine A. Helm
` khelm@stblaw.com
`
`67
`
` FITZPATRICK, CELLA, HARPER & SCINTO
` 1290 Avenue of the Americas
`8 New York, NY 10104-3800
` By: Robert S. Schwartz
`9 Brendan M. O'Malley
` rschwartz@fchs.com;
`10 bomalley@fchs.com
`11
`12 Appearing for Genentech, Inc.:
`13 DURIE TANGRI
` 217 Leidesdorff Street
`14 San Francisco, CA 94111
` By: Daralyn J. Durie
`15 Adam R. Brausa
` ddurie@durietangri.com;
`16 abrausa@durietangri.com
`17
`
`Also Present:
`18 Mark J. Stewart, in-house counsel,
` Eli Lilly and Company
`
`19
`20 Videographer:
`21 Wendy Viner, Merrill Legal Solutions
`22
`23
`24
`25
`
`1 W I T N E S S I N D E X
`2 Page
`3 SIR GREGORY WINTER (Sworn) ...........................4
`4 Examination by Ms. Durie ........................4
`
` E X H I B I T I N D E X
`
`56
`
`7
`
`Winter Description Page
`8 Ex.No.:
`9
`10 Exhibit 1 Expert Report of Sir .......................6
` Gregory Winter, CBE, FRS
`11 regarding invalidity of U.S.
` Patent Nos. 6,331,415 and
`12 7,923,221
`13 Exhibit 2 United States Patent .......................9
` No.: 6,331,415, December 18,
`14 2001
`15 Exhibit 3 Reply Expert Report of ....................36
` Sir Gregory Winter, CBE, FRS
`16 Regarding Invalidity of U.S.
` Patent Nos. 6,331,415 and
`17 7,923,221
`18 Exhibit 4 United States Patent .....................109
` No.: 4,816,567, March 28, 1989
`19 (Also marked PX9)
`20 Exhibit 5 United States Patent .....................137
` No.: 5,225,539, July 6, 1993
`
`21
`22
`23
`24
`25
`
`1-800-325-3376
`
`Merrill Corporation - New York
`www.merrillcorp.com/law
`
`

`
`SIR GREGORY WINTER - 1/19/2015
`
`Page 6
`
`Page 8
`
`1 I would like to do would be to refer to my deposition where
`2 I think I do deal with those two points.
`3 BY MS. DURIE:
`4 Q. Sure. Let me have marked as the first exhibit a
`5 copy of the expert report of Sir Gregory Winter.
`6 (Exhibit 1 marked for identification.)
`7 A. So in page 4, 20 it explains:
`8 "... specification must provide adequate written
`9 description of the invention ..."
`10 And it must explain how to use the invention, clear
`11 language. That's written description. And the enablement
`12 issue or the enablement requirement is when a person at the
`13 time of invention would, on looking at that, be able to
`14 practice the invention.
`15 Q. Is there any difference in your mind between the
`16 written description requirement and the enablement
`17 requirement?
`18 MS. HELM: Objection.
`19 A. Is there what, sorry?
`20 BY MS. DURIE:
`21 Q. Is there any difference in your mind between the
`22 written description requirement and the enablement
`23 requirement?
`24 MS. HELM: Objection: calls for a legal
`25 conclusion.
`
`1 A. I would say it teaches and provides guidance in
`2 combination with other prior art.
`3 Q. And so your understanding is that you can look to
`4 other prior art as well as what is written down in the
`5 patent itself to assess compliance with the written
`6 description requirement?
`7 A. Sorry, can you repeat that again?
`8 Q. Sure. So is it your understanding that you can
`9 look at other prior art as well as what is written within
`10 the patent itself to assess compliance with the written
`11 description requirement?
`12 MS. HELM: Objection. I object to this entire
`13 line of questioning as calling for legal conclusions.
`14 A. So what does that mean?
`15 MS. HELM: You still need to answer the question.
`16 I'm objecting as to the form.
`17 A. The form of the --
`18 MS. HELM: For calling for legal conclusions.
`19 A. Can you repeat that question again, sorry?
`20 BY MS. DURIE:
`21 Q. Sure. Is it your understanding then that you can
`22 look to other prior art as well as what is written within
`23 the patent itself in order to assess compliance with the
`24 written description requirement?
`25 MS. HELM: Same objection.
`
`Page 7
`
`Page 9
`
`1 A. My understanding had been that the written
`2 description essentially was what was written down; in other
`3 words, whether that is adequate on what's written down. And
`4 there are other factors come into enablement.
`5 BY MS. DURIE:
`6 Q. What are the additional factors that come into
`7 enablement?
`8 A. Well, I understand it would relate to the factors
`9 whether for example considering whether undue
`10 experimentation might be required in order for somebody to
`11 do that work. So the written description and enablement are
`12 very similar concepts but obviously written description is
`13 what is written. Enablement I took to be beyond the written
`14 description, plus. That was my interpretation.
`15 Q. Does the written description requirement as you
`16 have applied it require that what is written down teach a
`17 person of skill in the art how to practice the invention?
`18 MS. HELM: Objection: calls for a legal
`19 conclusion.
`20 A. Sorry, could you repeat that?
`21 BY MS. DURIE:
`22 Q. Sure. Does the written description requirement as
`23 you have applied it require that what is written down teach
`24 a person of ordinary skill in the art how to practice the
`25 invention?
`
`1 A. My understanding would be that that is the way that
`2 I have looked at this. Whether that is true, I don't know.
`3 BY MS. DURIE:
`4 Q. Do you agree that compliance with the written
`5 description requirement is tested relative to claim
`6 limitations?
`7 MS. HELM: Objection: calls for a legal conclusion
`8 and outside the scope of his report.
`9 A. And can you repeat that question again?
`10 BY MS. DURIE:
`11 Q. Sure. Do you agree that compliance with the
`12 written description requirement is tested relative to the
`13 limitations of a claim?
`14 A. I don't understand the question.
`15 Q. Fair enough. Let me have marked as the next
`16 exhibit a copy of U.S. patent 6,331,415.
`17 (Exhibit 2 marked for identification.)
`18 Do you recognize what I have put in front of you
`19 as one of the Cabilly patents that is at issue in this
`20 litigation?
`21 A. Yes, I do.
`22 Q. And if I refer to this patent, the '415 patent, as
`23 the Cabilly 2 patent, will you understand what I'm
`24 referring to?
`25 A. Yes, I do.
`
`1-800-325-3376
`
`Merrill Corporation - New York
`www.merrillcorp.com/law
`
`3 (Pages 6 to 9)
`
`

`
`SIR GREGORY WINTER - 1/19/2015
`
`Page 10
`
`Page 12
`
`1 Q. Now when you conducted your analysis of compliance
`2 with the written description requirement with respect to the
`3 Cabilly 2 patent, how did you go about that analysis?
`4 A. When I looked at the compliance of this for a
`5 written description?
`6 Q. Yes.
`7 MS. HELM: Objection: vague. The witness may
`8 refer to his report.
`9 A. Well, what I looked at was the claims on the patent
`10 and I looked at what those claims said and I looked at what
`11 was done in the patent and I looked at what one could
`12 reasonably infer at the time from prior art. So that's the
`13 essence of what I did.
`14 BY MS. DURIE:
`15 Q. So if in the patent you turn for example to
`16 claim 33, which should appear at the back of the patent.
`17 You undertook an analysis of whether the description of the
`18 Cabilly 2 patent provides an adequate written description
`19 for claim 33; is that right?
`20 A. Yep.
`21 Q. Have you heard of the term "the limitations of a
`22 claim"?
`23 A. I've heard of the term but I could probably do with
`24 some instruction on what it means if I'm going to be quizzed
`25 on it.
`
`1 said first and second DNA sequences."
`2 Do you understand claim 33 of the Cabilly 2 patent
`3 to require the co-expression of at least the variable domain
`4 of a heavy chain and the variable domain of a light chain in
`5 a single host cell?
`6 MS. HELM: Objection: calls for a legal
`7 conclusion.
`8 A. Sorry, can you repeat that question again?
`9 BY MS. DURIE:
`10 Q. Sure. Do you understand claim 33 of the Cabilly 2
`11 patent to require the co-expression of at least the variable
`12 domain of a heavy chain and the variable domain of a light
`13 chain in a single host cell?
`14 MS. HELM: Same objection.
`15 A. I took it that this claim covers a molecule which
`16 is an immunoglobulin molecule or in fact an immunologically
`17 functional molecule which would have heavy and light chains
`18 within it. That's what I had considered and I believe this
`19 does describe such a molecule. Whether it requires it, I'd
`20 have to think very carefully about the language of this, and
`21 whether it might allow the production of a single -- one of
`22 those as a single domain. And I don't believe it does but
`23 I think at the moment it is essentially describing -- it
`24 would certainly cover the variable domain of a heavy and
`25 light in the same associated fragment.
`
`Page 11
`
`Page 13
`
`1 Q. Fair enough. If I were to refer to the
`2 requirements of a claim would you understand what I'm
`3 referring to?
`4 A. The key features of the claim.
`5 Q. Did you undertake your written description analysis
`6 by focusing on the requirements of the claim?
`7 MS. HELM: Objection: calls for a legal
`8 conclusion.
`9 A. Essentially I'm a scientist so what I did is
`10 I looked at this and I said: what does this describe?
`11 BY MS. DURIE:
`12 Q. If we take a look at claim 33 and we see it's:
`13 "A process for producing an immunoglobulin molecule or
`14 an immunologically functional immunoglobulin fragment
`15 comprising at least the variable domains of the
`16 immunoglobulin heavy and light chains, in a single host
`17 cell, comprising:"
`18 And then it says:
`19 "independently expressing a first DNA
`20 sequence encoding at least the variable domain of the
`21 immunoglobulin heavy chain and a second DNA sequence
`22 encoding at least the variable domain of the
`23 immunoglobulin light chain so that said immunoglobulin
`24 heavy and light chains are produced as separate
`25 molecules in said single host cell transformed with
`
`1 BY MS. DURIE:
`2 Q. For purposes of assessing compliance with a written
`3 description requirement, have you focused in your analysis
`4 on what the claim covers?
`5 MS. HELM: Objection: calls for a legal conclusion
`6 and asked and answered.
`7 A. So what do I have to do? So I've answered it.
`8 MS. DURIE: You can still answer the question.
`9 Lilly's attorney can make objections for the record but
`10 you're still required to answer my questions.
`11 THE WITNESS: So can you repeat the question
`12 again?
`13 BY MS. DURIE:
`14 Q. Of course. For purposes of assessing compliance
`15 with a written description requirement, have you then
`16 focused on what the claim covers?
`17 MS. HELM: Same objection.
`18 A. I have focused on the fact that this claim covers
`19 two associated domains. That's what I focused on. I have
`20 not thought about other possibilities and I am not entirely
`21 sure whether they're there because I need to think about the
`22 claim carefully.
`23 BY MS. DURIE:
`24 Q. When you say "covers", what do you mean by that?
`25 A. Well I would mean that if you made a molecule, that
`
`1-800-325-3376
`
`Merrill Corporation - New York
`www.merrillcorp.com/law
`
`4 (Pages 10 to 13)
`
`

`
`SIR GREGORY WINTER - 1/19/2015
`
`Page 14
`
`Page 16
`
`1 you would have this claim asserted against you.
`2 Q. So "covers" is a word that you're using to capture
`3 the concept of what might infringe that claim; is that
`4 right?
`5 A. Correct.
`6 Q. In paragraph 21 of your report, and if I can direct
`7 you to that, you say:
`8 "I understand the written description
`9 requirement is satisfied when the patent describes each
`10 and every limitation of a patent claim with reasonable
`11 clarity so that a POSA at the time of the invention
`12 would understand that the inventors were in possession
`13 of the full scope of the claimed invention as of the
`14 filing date of the patent."
`15 Do you understand what is written there to equate
`16 to an analysis of what is covered by the claim?
`17 MS. HELM: Objection: calls for a legal conclusion
`18 and form. Confusing.
`19 A. I'm sorry, I'm distracted again. So what was the
`20 question again? Do I what?
`21 BY MS. DURIE:
`22 Q. Do you understand what you wrote in paragraph 21 to
`23 equate to what is covered by a claim?
`24 A. No.
`25 Q. What do you understand the distinction to be?
`
`1 possible embodiments that would be covered by the claim?
`2 A. I haven't thought about it, whether it would have
`3 to cover every single embodiment of a claim. I don't
`4 think -- I think a written description, as far as I can see,
`5 would have to be able to cover some of the major embodiments
`6 of the claim. I didn't believe it would have to cover every
`7 possibility.
`8 Q. You have expressed an opinion regarding in vivo
`9 assembly; is that correct?
`10 A. Yeah.
`11 MS. HELM: Objection: overbroad.
`12 BY MS. DURIE:
`13 Q. And I understand your opinion is limited to in vivo
`14 assembly or the lack thereof in mammalian host cells; is
`15 that right?
`16 A. Yeah.
`17 Q. Turning to claim 33 of the Cabilly 2 patent, do you
`18 see any reference to --
`19 A. Sorry, it's gone.
`20 Q. Turning to claim 33 of the Cabilly 2 patent do you
`21 see any reference to in vivo assembly in claim 33?
`22 MS. HELM: Objection: calls for a legal
`23 conclusion.
`24 A. I see no requirement for in vivo assembly. It
`25 could be assembled in vivo or it could be assembled in
`
`Page 15
`
`Page 17
`
`1 MS. HELM: Objection.
`2 A. This refers to every limitation. I have just dealt
`3 with one particular situation in this case.
`4 BY MS. DURIE:
`5 Q. What situation is that?
`6 A. The situation, what I've said is this claim -- you
`7 asked me what this claim covered or what the requirements
`8 were. I'm saying this claim covers or perhaps it might even
`9 be the full requirement covers an associated heavy and light
`10 chain. Right? There may possibly be additional features of
`11 that that actually that I haven't looked at or thought about
`12 if I were to analyse that carefully.
`13 Q. Is it your understanding that in order to comply
`14 with the written description requirement then the patent
`15 must describe all the possible embodiments that might be
`16 covered by a particular claim?
`17 MS. HELM: Objection: asked and answered and again
`18 this entire line of questioning is calling for legal
`19 conclusions.
`20 A. I'm sorry these are quite -- these are more
`21 legalistic questions. Could you just go over it again?
`22 BY MS. DURIE:
`23 Q. Sure, of course. In performing your analysis did
`24 you understand that in order to comply with the written
`25 description requirement the patent must describe all the
`
`1 vitro, if it were assembled.
`2 BY MS. DURIE:
`3 Q. Would you agree that claim 33 does not include as a
`4 specific requirement the location of where assembly happens?
`5 MS. HELM: Objection: vague.
`6 A. I'm sorry, repeat the question?
`7 BY MS. DURIE:
`8 Q. Sure. Would you agree that claim 33 does not
`9 include as a specific requirement the location of where
`10 assembly happens?
`11 MS. HELM: Same objection and again calls for a
`12 legal conclusion.
`13 A. It seems to -- well, I can't see any -- there's a
`14 specification it's "produced as separate molecules" in a
`15 "single host cell" but it doesn't say where it's assembled.
`16 BY MS. DURIE:
`17 Q. Would you agree that the description of the Cabilly
`18 2 patent describes a method that permits the independent
`19 expression of a first DNA sequence encoding at least the
`20 variable domain of an immunoglobulin heavy chain and a
`21 second DNA sequence encoding at least the variable domain of
`22 an immunoglobulin light chain?
`23 A. Did you say claim 33 or just Cabilly 2?
`24 Q. So the question was, does the Cabilly 2
`25 description, so the patent in its entirety -- and I'm going
`
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`
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`
`5 (Pages 14 to 17)
`
`

`
`SIR GREGORY WINTER - 1/19/2015
`
`Page 18
`
`Page 20
`
`1 to break down claim 33 into its constituent parts.
`2 So my first question is, does the description of the
`3 Cabilly 2 patent describe a method that permits one to
`4 "independently [express] a first DNA sequence encoding at
`5 least the variable domain of [an] immunoglobulin heavy chain
`6 and a second DNA sequence encoding at least the variable
`7 domain of [an] immunoglobulin light chain"?
`8 MS. HELM: Objection: calls for a legal
`9 conclusion.
`10 A. I think we would have to -- I'd have to say I don't
`11 believe it does.
`12 BY MS. DURIE:
`13 Q. And why is that?
`14 A. That's essentially because the description, it's
`15 not clear from the description whether you've actually got
`16 an immunoglobulin. So you've got an immunoglobulin -- so
`17 you're saying -- sorry, start again.
`18 Q. So I want to start by focusing just on this portion
`19 of claim 33. So you see that claim 33 includes a
`20 requirement of "independently expressing a first DNA
`21 sequence encoding at least the variable domain of [an]
`22 immunoglobulin heavy chain and a second DNA sequence
`23 encoding at least the variable domain of [an] immunoglobulin
`24 light chain". Do you see that?
`25 A. Yes, I do.
`
`1 BY MS. DURIE:
`2 Q. We'll get there. Bear with me. I want to take
`3 this in bite-sized pieces so we can figure out where we have
`4 areas of disagreement.
`5 A. I see. Okay, yes.
`6 Q. So I want to start just with this portion -- let me
`7 start with just "a first DNA sequence encoding at least the
`8 variable domain of the immunoglobulin heavy chain and a
`9 second DNA sequence encoding at least the variable domain of
`10 the immunoglobulin light chain". Would you agree that the
`11 Cabilly specification describes such sequences?
`12 MS. HELM: Same objection and asked and answered.
`13 A. The patent specification describes such sequences.
`14 BY MS. DURIE:
`15 Q. Now, as you alluded to, there is a requirement of
`16 independently expressing those DNA sequences?
`17 A. Yeah.
`18 MS. HELM: Objection: mischaracterizing the
`19 witness.
`20 BY MS. DURIE:
`21 Q. In your opinion does the Cabilly 2 patent describe
`22 a method for independently expressing those DNA sequences?
`23 MS. HELM: Objection: calls for a legal
`24 conclusion.
`25 A. The patent describes a way for example of putting
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`1 Q. Would you agree that the Cabilly 2 specification
`2 describes such DNA sequences?
`3 MS. HELM: Objection: calls for a legal
`4 conclusion.
`5 A. The Cabilly 2 specification describes such DNA
`6 sequences and it describes expressing a -- it describes
`7 expressing a protein. The question is what you mean by
`8 variable domain? So "encode" is a variable domain, but what
`9 do you mean by variable domain? It's something that's
`10 folded, or not? Or do you just mean the lump of
`11 polypeptide?
`12 Q. The claim limitation that I read you related to a
`13 "DNA sequence encoding a variable domain"; correct?
`14 MS. HELM: Objection.
`15 A. "Independently expressing". What you read me was
`16 "independently expressing a first DNA sequence," right. So
`17 the question is, I guess that DNA sequence independently
`18 expressing the first -- the point is, if you look further up
`19 that claim it refers to a process for producing an
`20 immunoglobulin molecule. Right? So we're looking at that
`21 claim is, you've got a comprising, then you're going into
`22 this stuff here. But actually the question is, the
`23 fundamental question is, this first point, the first part of
`24 this: did you or does it describe a process for producing an
`25 immunoglobulin molecule?
`
`1 the different -- the heavy chain on one plasmid and the
`2 light chain on another plasmid which effectually might be
`3 regarded as independent because they should be -- they would
`4 in that case would have separate promoters and therefore
`5 would be independently expressed.
`6 Q. So would you then agree that the Cabilly 2 patent
`7 describes a method for independently expressing a first and
`8 second DNA sequence?
`9 MS. HELM: Same objection.
`10 A. With the caveats I put earlier, yes, it does.
`11 BY MS. DURIE:
`12 Q. What is the caveat?
`13 A. The caveat I have referred to. Is the caveat, the
`14 whole thing relates to an immunoglobulin molecule.
`15 Q. So let's now get there. So the next requirement of
`16 the claim is "... so that said immunoglobulin heavy and
`17 light chains are produced as separate molecules in said
`18 single host cell transformed with said first and second DNA
`19 sequences."
`20 Do you see that?
`21 A. Yes.
`22 Q. Would you agree that the Cabilly 2 patent describes
`23 a method that permits the production of the heavy and light
`24 chains as separate molecules in a single host cell?
`25 MS. HELM: Objection: calls for a legal
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`1-800-325-3376
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`Merrill Corporation - New York
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`6 (Pages 18 to 21)
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`

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`SIR GREGORY WINTER - 1/19/2015
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`1 conclusion.
`2 A. I believe they are expressed from that, yes.
`3 BY MS. DURIE:
`4 Q. Turning to the beginning of claim 33, as you've
`5 alluded to, it is "A process for producing an immunoglobulin
`6 molecule or an immunologically functional immunoglobulin
`7 fragment ..."
`8 Is it your opinion that the Cabilly 2 patent
`9 describes a method that permits the production of an
`10 immunoglobulin molecule or an immunologically functional
`11 immunoglobulin fragment?
`12 MS. HELM: Objection: calls for a legal
`13 conclusion.
`14 A. I believe that it did not.
`15 BY MS. DURIE:
`16 Q. And why is that?
`17 A. Because I didn't have the data to show that it did.
`18 Q. And when you refer to the data, are you referring
`19 to the data in the patent regarding the in vitro
`20 reconstitution work that was recorded?
`21 A. Yes, I am.
`22 Q. So is your opinion with respect to the lack of
`23 written description of the Cabilly 2 patent dependent at
`24 least in part on your understanding that the data in the
`25 Cabilly 2 patent does not show the in vitro reconstitution
`
`1 particular segment is actually, fine, that's what you would
`2 do, you would try to express an antibody, you would try to
`3 refold it from those different bits and pieces.
`4 Q. How does your understanding with respect to the
`5 significance of the in vitro reconstitution work bear on
`6 your opinions with respect to the written description
`7 support for the claims of the Cabilly patents?
`8 MS. HELM: Objection. This line of questioning is
`9 outside the scope of the witness's opinion in the report.
`10 A. I'm going to have to go back to the question again.
`11 Every time you interrupt I forget, but that's fine.
`12 BY MS. DURIE:
`13 Q. You alluded to the in vitro reconstitution results
`14 in your prior answers.
`15 MS. HELM: Objection: mischaracterizing the
`16 witness.
`17 BY MS. DURIE:
`18 Q. And I want to understand what, if any, the
`19 significance of your interpretation of those results is for
`20 your opinions with respect to the written description
`21 support for the claims of the Cabilly patents?
`22 MS. HELM: Objection. Mischaracterizing the
`23 witness's testimony and his report.
`24 A. So you're telling me to what extent -- let's put it
`25 another way. Suppose they had made a functional fragment in
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`1 of the chains?
`2 MS. HELM: Objection: overbroad.
`3 A. If we deal just with expression in E. coli, E. coli
`4 assembled in vitro. So dealing with that particular, I am
`5 not convinced it showed it. But there's much more. There's
`6 much more -- there's lots of other aspects in which there is
`7 even less description and no evidence.
`8 BY MS. DURIE:
`9 Q. Fair enough. And you're going to have ample
`10 opportunity, I'm sure, to get into all of that. But
`11 focusing on what you just said, is your opinion that the
`12 Cabilly 2 patent claims lack an adequate written description
`13 dependent in part on your belief that the in vitro
`14 reconstitution data does not show the production of an
`15 immunoglobulin molecule or an immunologically functional
`16 immunoglobulin fragment?
`17 A. I don't think it's written description. The
`18 written description is there describing how you would go
`19 about making such a molecule, but it doesn't actually give
`20 you any reason to believe that they made it. So the written
`21 description takes you through the various processes and it
`22 suggests that you would try to refold the molecule, which is
`23 absolutely fine, but that's -- but it doesn't actually
`24 persuade me that it was refolded.
`25 The description as far as I could see for that
`
`1 E. coli. Suppose that had happened and they demonstrated
`2 that. Then I would say, that still doesn't change my view
`3 on all the rest of it because the claims go much wider than
`4 E. coli. But on the matter of E. coli, I'm not convinced
`5 that they did show it, which is a separate matter not to do
`6 with written description.
`7 BY MS. DURIE:
`8 Q. So your opinions on written description don't turn
`9 in any way on whether the inventors in fact were successful
`10 in reconstituting the chains?
`11 MS. HELM: Objection. Mischaracterizing the
`12 witness and calls for a legal conclusion.
`13 A. My objections don't turn on it is what you said.
`14 My objections cer