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`Case No. 2:15-CV-05685-GW-AGR
`
`UNITED STATES DISTRICT COURT
`CENTRAL DISTRICT OF CALIFORNIA
`WESTERN DIVISION
`___________________________________
`SANOFI-AVENTIS U.S., LLC and
`REGENERON PHARMACEUTICALS,INC.,
`Plaintiffs.
`V.
`GENENTECH, INC., and CITY OF HOPE Ctrm: 10, Springs Street Floor
`Judge: George H. Wu
`Defendants.
`___________________________________
`GENENTECH, INC., and CITY OF HOPE
`Counterclaim Plaintiffs,
`V.
`SANOFI-AVENTIS U.S., LLC and
`REGENERON PHARMACEUTICALS, INC.
`Counterclaim Defendants.
`___________________________________
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`___________________________________
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`___________________________________
`SANOFI-AVENTIS U.S., LLC AND
`REGENERON PHARMACEUTICALS, INC.
`Petitioners
`
`v.
`GENENTECH, INC., AND CITY OF HOPE
`Patent Owners
`U.S. Patent No. 6,331,415
`Appl. No. 07/205,419, filed June 10, 1988
`Issued: Dec. 18, 2001
` Title: Methods of Producing Immunoglobulins, Vectors and
`Transformed Host Cells for Use Therein
`___________________________________
`IPR Trial No. IPR2015-01624
`VIDEOTAPED DEPOSITION OF JOHN FIDDES, PH.D.
`
`Mylan/Merck v. Genentech
`IPR2016-00170
`Genentech Exhibit 2139
`
`Mylan v. Genentech
`IPR2016-00710
`Merck Ex. 1116, Pg. 1
`
`
`
`Case No. 2:15-CV-05685-GW-AGR
`
`UNITED STATES DISTRICT COURT
`CENTRAL DISTRICT OF CALIFORNIA
`WESTERN DIVISION
`___________________________________
`SANOFI-AVENTIS U.S., LLC and
`REGENERON PHARMACEUTICALS,INC.,
`Plaintiffs.
`V.
`GENENTECH, INC., and CITY OF HOPE Ctrm: 10, Springs Street Floor
`Judge: George H. Wu
`Defendants.
`___________________________________
`GENENTECH, INC., and CITY OF HOPE
`Counterclaim Plaintiffs,
`V.
`SANOFI-AVENTIS U.S., LLC and
`REGENERON PHARMACEUTICALS, INC.
`Counterclaim Defendants.
`___________________________________
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`___________________________________
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`___________________________________
`SANOFI-AVENTIS U.S., LLC AND
`REGENERON PHARMACEUTICALS, INC.
`Petitioners
`
`v.
`GENENTECH, INC., AND CITY OF HOPE
`Patent Owners
`U.S. Patent No. 6,331,415
`Appl. No. 07/205,419, filed June 10, 1988
`Issued: Dec. 18, 2001
` Title: Methods of Producing Immunoglobulins, Vectors and
`Transformed Host Cells for Use Therein
`___________________________________
`IPR Trial No. IPR2015-01624
`VIDEOTAPED DEPOSITION OF JOHN FIDDES, PH.D.
`
`Mylan/Merck v. Genentech
`IPR2016-00170
`Genentech Exhibit 2139
`
`Mylan v. Genentech
`IPR2016-00710
`Merck Ex. 1116, Pg. 1
`
`
`
`JOHN FIDDES, PH.D.
`
`2
`
` VIDEOTAPED DEPOSITION OF JOHN
` FIDDES, PH.D., taken on behalf of
` the Plaintiffs and Petitioners, at
` 3000 El Camino Real, Suite 300,
` Palo Alto, California, commencing
` at 9:30 A.M. on July 19, 2016,
` before PATRICIA L. HUBBARD,
` CSR #3400, a Certified Shorthand
` Reporter in and for the State of
` California, pursuant to Notice.
`
`
`
`
`
`Reported by:
`PATRICIA L. HUBBARD
`Job No. 45385
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`DAVID FELDMAN WORLDWIDE, INC.
`450 Seventh Avenue - Ste 500, New York, NY 10123 1.800.642.1099
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`Merck Ex. 1116, Pg. 2
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`JOHN FIDDES, PH.D.
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` A P P E A R A N C E S:
`
` For the Plaintiffs Sanofi-Aventis:
` Mayer Brown, LLP
` 71 S. Wacker Drive
` Chicago, Illinois 60606
` 312-782-0600
` BY: JOHNATHAN H. KIM, Esq.
` jkim@mayerbrown.com
`
` MAYER BROWN, LLP
` 1221 Avenue of the Americas
` New York, New York 10020-1001
` BY: RICHARD J. McCORMICK, ESQ.
` rmccormick@mayerbrown.com
`
` For the Defendants:
` Durie Tangri
` 217 Leidesdorff Street
` San Francisco, CA 94111
` BY: ADAM R. BRAUSA, ESQ.
` abrausa@durietangri.com
`
`
`
`
`DAVID FELDMAN WORLDWIDE, INC.
`450 Seventh Avenue - Ste 500, New York, NY 10123 1.800.642.1099
`
`Merck Ex. 1116, Pg. 3
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`JOHN FIDDES, PH.D.
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` APPEARANCES OF COUNSEL: (Continued)
`
` For the Defendants and Patent Owners:
` WILMER CUTLER PICKERING HALE AND DORR, LLP
` 1875 Pennsylvania Avenue, NW
` Washington, DC 20006
` BY: OWEN ALLEN, ESQ.
` owen.allen@wilmerhale.com
`
` Also Present:
` Warren Nguyen, Videographer
` Zaneta Kim
`
`DAVID FELDMAN WORLDWIDE, INC.
`450 Seventh Avenue - Ste 500, New York, NY 10123 1.800.642.1099
`
`Merck Ex. 1116, Pg. 4
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`
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`JOHN FIDDES, PH.D.
`
`5
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` I N D E X
` WITNESS PAGE
` JOHN FIDDES, PH.D.
` (By Mr. McCormick) 9
` E X H I B I T S
` PAGE
` EXHIBIT DESCRIPTION REFERENCED
`
` Exhibit 1 Expert Declaration of John 11
` Fiddes, Ph.D. in Patent and
` Trademark Office matter
`
` Exhibit 2 Expert Report of John Fiddes, 11
` Ph.D.
` Exhibit 3 Transcript of Videotaped 16
` Deposition of John Fiddes,
` Ph.D. taken January 21, 2015
` Exhibit 4 U.S. Patent Number 4,487,835 69
` Exhibit 5 U.S. Patent Number 4,371,614 82
` Exhibit 6 U.S. Patent Number 4,762,785 88
` Exhibit 7 U.S. Patent Number 4,476,227 98
` Exhibit 8 U.S. Patent Number 4,362,867 104
` Exhibit 9 U.S. Patent Number 4,396,601 109
` Exhibit 10 U.S. Patent Number 6,331,415 120
` Exhibit 11 U.S. Patent Number 7,923,221 120
` Exhibit 12 Expression of eukaryotic 129
` genes in E. coli T.J.R. Harris
`
`DAVID FELDMAN WORLDWIDE, INC.
`450 Seventh Avenue - Ste 500, New York, NY 10123 1.800.642.1099
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`Merck Ex. 1116, Pg. 5
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`JOHN FIDDES, PH.D.
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`6
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` E X H I B I T S (Continued)
` PAGE
` EXHIBIT DESCRIPTION REFERENCED
`
` Exhibit 13 U.S. Patent Number 5,439,818 179
` Exhibit 14 U.S. Patent Number 5,514,566 180
` Exhibit 15 U.S. Patent Number 5,851,801 191
` Exhibit 16 U.S. Patent Number 5,840,545 193
` Exhibit 17 Article by B.H. Frank and 205
` R.E. Chance
` Exhibit 18 U.S. Patent Number 4,495,280 214
` Exhibit 19 File Wrapper for Bujard 219
` U.S. Patent Number 4,495,280
`
` INFORMATION REQUESTED:
` (NONE)
`
` WITNESS INSTRUCTED NOT TO ANSWER:
`
` (NONE)
`
`DAVID FELDMAN WORLDWIDE, INC.
`450 Seventh Avenue - Ste 500, New York, NY 10123 1.800.642.1099
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`Merck Ex. 1116, Pg. 6
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`JOHN FIDDES, PH.D.
`
` PALO ALTO, CALIFORNIA
` JULY 19, 2016
` * * *
`
`7
`
` VIDEOTAPE OPERATOR: This begins the
` video deposition of Dr. John Fiddes in the matter of
` Sanofi-Aventis U.S., L.L.C. and Regeneron
` Pharmaceuticals, Incorporated versus Genentech,
` Incorporated and City of Hope in the United States
` District Court, Central Division of California, or
` Western Division, case number 2:15-cv-05685.
` This deposition is also in the matter of
` Sanofi-Aventis, U.S., L.L.C., Regeneron
` Pharmaceuticals, Incorporated and Genzyme
` Corporation versus Genentech, Incorporated and City
` of Hope in the -- before the Patent Trial and Appeal
` Board, case IPR2015-01624.
` This deposition is being held at
` 3000 El Camino Real in Palo Alto, California on
` July 19, 2016 at approximately 9:33 A.M.
` My naming is Warren Nguyen from the firm
` of David Feldman Worldwide. And I am the legal
` video specialist.
` The court reporter is Patricia Hubbard
` in association with David Feldman Worldwide.
`
`DAVID FELDMAN WORLDWIDE, INC.
`450 Seventh Avenue - Ste 500, New York, NY 10123 1.800.642.1099
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`Merck Ex. 1116, Pg. 7
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`JOHN FIDDES, PH.D.
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` Will counsel please introduce
` themselves.
` MR. McCORMICK: Rich McCormick from
` Mayer Brown Law Firm for Sanofi, Regeneron and
` Genzyme.
` MR. KIM: Jonathan Kim from Mayer Brown
` for Sanofi, Regeneron and Genzyme.
` MR. McCORMICK: And with us today is
` Zaneta Kim from Mayer Brown, as well.
` MR. BRAUSA: Adam Brausa from Durie
` Tangri here on behalf of Genentech, City of Hope and
` the witness, Dr. John Fiddes.
` MR. ALLEN: Owen Allen from Wilmer Hale
` also here on behalf of Genentech, City of Hope and
` the witness.
` THE WITNESS: John Fiddes.
` VIDEOTAPE OPERATOR: Will the court
` reporter please swear in the witness.
` ///
` ///
` ///
` ///
` ///
` ///
` ///
`
`DAVID FELDMAN WORLDWIDE, INC.
`450 Seventh Avenue - Ste 500, New York, NY 10123 1.800.642.1099
`
`Merck Ex. 1116, Pg. 8
`
`
`
`JOHN FIDDES, PH.D.
`
`9
`
` JOHN FIDDES, PH.D.,
` called as a witness, having been
` sworn, was examined and testified
` as follows:
`
` EXAMINATION
` BY MR. McCORMICK:
` Q. Hi, good morning, Dr. Fiddes.
` It's not a longy; it's a shorty, then,
` right? Okay.
` A. To answer, yes. Good morning.
` Q. Good morning.
` So, you and I have met obviously about a
` year and a half ago.
` You recall that?
` A. I do.
` Q. I took your deposition in another case
` relating to the same patents that we're going to
` talk about today?
` A. Correct.
` Q. The ground rules haven't changed since
` that time. I'll just remind you what they are.
` You are now under oath. You have to --
` as -- as the court reporter said, you'll be telling
` the truth and answering my questions truthfully.
`
`DAVID FELDMAN WORLDWIDE, INC.
`450 Seventh Avenue - Ste 500, New York, NY 10123 1.800.642.1099
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`JOHN FIDDES, PH.D.
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` You understand that?
` A. I do.
` Q. It's important that you verbalize your
` answers, because she needs to pick up a "yes" or a
` "no" or whatever it is you're saying. And head nods
` or head shakes are just not going to be enough for
` her.
` Okay?
` A. I understand.
` Q. If any of my questions aren't clear,
` just let me know, and I'll try to clarify them for
` you.
` A. Okay.
` Q. And if you want to take a break at any
` time, just let me know, and we'll accommodate that.
` A. Thank you.
` Q. Okay. So you've prepared some written
` opinions in these proceedings regarding what we've
` been calling the Cabilly II and Cabilly III patents,
` correct?
` A. Correct.
` MR. McCORMICK: So, let me mark -- well,
` actually the first one's already been marked. It
` is --
` Let me think of how to do this, because
`
`DAVID FELDMAN WORLDWIDE, INC.
`450 Seventh Avenue - Ste 500, New York, NY 10123 1.800.642.1099
`
`Merck Ex. 1116, Pg. 10
`
`
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`JOHN FIDDES, PH.D.
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` this is also the litigation.
` But why don't -- why don't we mark
` everything -- even things in the IPR.
` So let's mark this as Fiddes 1, and this
` is a document entitled "Expert Declaration of John
` Fiddes, Ph.D." It has been marked as an Exhibit
` number 2019 in the IPR proceeding.
` (Whereupon the document referred
` to was marked Fiddes Exhibit 1 by
` the Certified Shorthand Reporter
` and is attached hereto.)
` MR. McCORMICK: And then let me mark as
` Fiddes -- Fiddes Exhibit 2 a document entitled
` "Expert Report of John Fiddes, Ph.D." And this is
` in the -- the District Court litigation.
` (Whereupon the document referred
` to was marked Fiddes Exhibit 2 by
` the Certified Shorthand Reporter
` and is attached hereto.)
` THE WITNESS: Thank you.
` BY MR. McCORMICK:
` Q. And, Dr. Fiddes, you recognize the
` document that's been marked as Exhibit 1 as a
` declaration that you have submitted to the U.S.
` Patent and Trademark Office regarding your opinions
`
`DAVID FELDMAN WORLDWIDE, INC.
`450 Seventh Avenue - Ste 500, New York, NY 10123 1.800.642.1099
`
`Merck Ex. 1116, Pg. 11
`
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`JOHN FIDDES, PH.D.
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` on the Cabilly III Patent -- sorry -- the Cabilly II
` Patent?
` A. My opinions on Cabilly III?
` Q. I think the declaration -- looking at
` the declaration Fiddes 1, that would be the IPR
` proceeding in the Patent and Trademark Office that
` concerns the Cabilly II Patent. But you're free to
` look at the document and confirm that.
` MR. BRAUSA: It might be helpful, maybe
` I can just stipulate the Cabilly '415 Patent is also
` referred to as the Cabilly II Patent.
` BY MR. McCORMICK:
` Q. Apologies. Yes, yes.
` A. I was getting mixed up as to the
` numbers.
` Q. Right, right.
` A. Okay.
` Q. So let's just be clear --
` A. Okay.
` Q. -- right now.
` So I'll be referring today as a
` shorthand to two different U.S. patents. One is
` number 6,331,415, and I'm going to call that the
` Cabilly II Patent.
` A. Uh-huh.
`
`DAVID FELDMAN WORLDWIDE, INC.
`450 Seventh Avenue - Ste 500, New York, NY 10123 1.800.642.1099
`
`Merck Ex. 1116, Pg. 12
`
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`JOHN FIDDES, PH.D.
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` Q. And, sir, that patent is the subject of
` your expert declaration --
` A. Yes.
` Q. -- is that correct?
` A. That is correct.
` Q. Okay. I'm also going to be referring to
` the U.S. Patent 7,923,221. And that is what we've
` been calling in shorthand the Cabilly III Patent.
` A. Yeah.
` Q. And if you look at the document that has
` been marked as Exhibit 2, is that your written
` expert report concerning your opinions regarding the
` Cabilly III Patent?
` A. Yes, it is.
` Q. Okay. Thank you.
` Now, you understand that Exhibit 1,
` which is your declaration in the United States
` Patent and Trademark Office, that is -- that that
` proceeding is what's called an inter partes review?
` A. I understand that, correct.
` Q. And you understand that the document
` that's been marked as Exhibit 2 is in the proceeding
` in the United States District Court in the Central
` District of California?
` A. Yes, I understand that.
`
`DAVID FELDMAN WORLDWIDE, INC.
`450 Seventh Avenue - Ste 500, New York, NY 10123 1.800.642.1099
`
`Merck Ex. 1116, Pg. 13
`
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`JOHN FIDDES, PH.D.
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` Q. And it is a Federal -- Federal District
` Court litigation.
` You understand that?
` A. I do.
` Q. All right. You understand that the
` Federal District Court litigation, that's going to
` be a jury trial?
` A. Yes.
` Q. And we don't know when the date is, but
` it's presumably -- if it goes to trial, it will be
` at some point probably in the next year.
` A. I understand that.
` Q. Okay. Now, as you sit here right now,
` though, do you understand that the testimony you're
` giving with respect to your opinions in what we've
` marked as Exhibit 1, your declaration, that this --
` with respect to those opinions, this is your trial
` testimony?
` A. I do.
` Q. Okay. You understand that a panel of
` three judges at the U.S.P.T.O. are going to be
` reading the transcript of this proceeding?
` A. I understand that.
` Q. And you understand they might be looking
` at the videotape recording of this proceeding?
`
`DAVID FELDMAN WORLDWIDE, INC.
`450 Seventh Avenue - Ste 500, New York, NY 10123 1.800.642.1099
`
`Merck Ex. 1116, Pg. 14
`
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`JOHN FIDDES, PH.D.
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` A. I understand that, as well.
` Q. And they will be considering the
` substance of your testimony today?
` A. Yes.
` Q. And they'll also be judging your
` credibility?
` A. I understand that.
` Q. Okay. And your credibility's important
` to you, right?
` A. Certainly.
` Q. Okay. To date, sir, how much have you
` billed Genentech and City of Hope with respect to
` your services, your expert services?
` And you can just -- combined for both
` different matters.
` A. Combined for both I believe I've spent
` since starting this back in, I think, September a
` little bit over 200 hours.
` Q. Okay. And your billing rate is $650 an
` hour?
` A. That is correct.
` Q. Do you have rough estimate of how much
` you billed on the District Court litigation versus
` the inter partes review?
` A. I think the simplest answer is 50/50,
`
`DAVID FELDMAN WORLDWIDE, INC.
`450 Seventh Avenue - Ste 500, New York, NY 10123 1.800.642.1099
`
`Merck Ex. 1116, Pg. 15
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`JOHN FIDDES, PH.D.
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` because there's a lot of overlap, and a lot of the
` research papers I read are the same for both.
` So I would, rough approximation, put it
` 50/50.
` Q. Fair enough.
` So, let me mark as Fiddes Exhibit 3 --
` MR. KIM: (Indicating.)
` MR. McCORMICK: No. The depo
` transcript.
` BY MR. McCORMICK:
` Q. -- a deposition transcript in a case
` captioned Bristol-Myer Squibb versus Genentech and
` City of Hope.
` (Whereupon the document referred
` to was marked Fiddes Exhibit 3 by
` the Certified Shorthand Reporter
` and is attached hereto.)
` THE WITNESS: Thank you.
` BY MR. McCORMICK:
` Q. And, Dr. Fiddes, I'll represent to you
` that this is the -- well, this is a transcript from
` the deposition that -- well, this is -- this is the
` transcript of your deposition from the prior case
` that you worked on with respect to the Cabilly II
` and III Patents?
`
`DAVID FELDMAN WORLDWIDE, INC.
`450 Seventh Avenue - Ste 500, New York, NY 10123 1.800.642.1099
`
`Merck Ex. 1116, Pg. 16
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`JOHN FIDDES, PH.D.
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` A. That is good.
` Q. And you recall that deposition?
` A. I do.
` Q. All right. And you recall that you and
` I were -- were there that day and I asked you
` questions?
` A. I do.
` Q. Okay. So, I just want to go into your
` background a little bit.
` You did your post doc at U.C.S.F. from
` 1977 to 1980?
` A. That is correct.
` Q. And I think -- you're free to refer to
` your declaration, but you worked on a number of
` proteins in the lab of Dr. Goodman?
` A. Yes.
` Q. You worked on human growth hormone?
` A. Yes.
` Q. Human chorionic somatomammotropin?
` A. Correct.
` Q. And you worked on human glycoprotein
` hormone genes?
` A. Yes.
` Q. During your time at U.C.S.F. did you do
` any recombinant expression of those proteins?
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` A. I did not give expression of those
` proteins at that time.
` Q. What was the nature of your -- of your
` work or your study with respect to those proteins?
` A. The focus of my study was to isolate
` cDNA's and genes, encoding these proteins to
` understand the structure and organization of the
` genes.
` Q. Okay. So you isolated or you -- we'll
` get to that, I suppose, but your -- your goal was to
` isolate cDNA encoding for the proteins that I just
` mentioned?
` A. cDNA and also genomic sequences.
` Q. Okay. May I ask you, the human
` glycoprotein hormone genes, how many different genes
` or proteins are encoded by those genes?
` A. It is a family of four hormones: Human
` chorionic gonadotropin, human luteinizing hormone,
` human follicle-stimulating hormone and human
` thyroid-stimulating hormone.
` Q. Okay. So then all told it sounds like
` you worked on, at least with respect to what we've
` been discussing, seven different proteins; the four
` you just mentioned, human growth hormone, human
` chorionic somatomammotropin -- I'm sorry. Six, the
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` four you mentioned plus those two, correct?
` A. Correct. It's a little bit more
` complicated than that in that -- but I think that's
` an okay statement.
` Q. Okay. So let's talk about -- let's
` break these down one by one.
` So let's talk about human growth
` hormones.
` A. Yes.
` Q. You were attempting to isolate genomic
` DNA for human growth hormone?
` A. That is --
` MR. BRAUSA: Objection.
` THE WITNESS: I isolated a genomic DNA
` for human growth hormones.
` BY MR. McCORMICK:
` Q. Okay. You did in fact isolate the
` genomic DNA?
` A. I did in fact, yes.
` Q. And were you able to -- to get the
` corresponding cDNA from that genomic DNA for human
` growth hormone?
` (Off-the-record discussion.)
` BY MR. McCORMICK:
` Q. Were you able to get the corresponding
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`DAVID FELDMAN WORLDWIDE, INC.
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` cDNA for human growth hormone?
` A. The cDNA for human growth hormone had
` been isolated previously.
` Q. Okay. Let's move on to human chorionic
` somatomammotropin.
` Did you successfully isolate genomic DNA
` encoding for that protein?
` A. Yes, I got the gene isolated for that
` protein.
` Q. Okay. And were you able to get the
` corresponding cDNA for that protein?
` A. As with growth hormone, that cDNA had
` been isolated previously.
` Q. Now, with respect to the four hormones
` that are -- comprise the human glycoprotein hormone
` genes, were you successful in isolating the genomic
` DNA encoding for those four proteins?
` A. I started by isolating the cDNA as a
` step towards getting the genomic sequences.
` Q. Okay. So then am I -- is it correct to
` say that you were successful in isolating the cDNA
` for those four proteins?
` A. This is where it's a little bit more
` complicated, as I mentioned earlier on, as these are
` a family of four hormones that share a common alpha
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` subunit and individual separate beta subunits.
` So, I isolated the cDNA for the common
` alpha subunit, so that is for all of members of the
` family, and the cDNA for hCG, which is one -- the
` beta subunit for one member of the family, hCG; hCG
` being the common abbreviation for human chorionic
` gonadotropin.
` Q. Okay. And then there are -- there are
` three other proteins that have the -- have the beta
` subunit? Is that what you said?
` A. Yes.
` Q. And those three other proteins are --
` there's human luteinizing hormone?
` A. Frequently called LH.
` Q. LH. Right.
` What were the other two? I apologize.
` A. Follicle-stimulating hormone or FSH.
` Q. And the third one?
` A. And thyroid-stimulating hormone or TSH.
` The abbreviations are probably the
` simplest.
` Q. Right. Okay. So I'll use those
` abbreviations.
` So you were able to -- to isolate the
` cDNA for the alpha subunit for all four of those
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` proteins?
` A. That is correct.
` Q. And it's the same -- it's the same
` alpha -- it's the same protein, the same -- the same
` cDNA sequence?
` A. That is correct.
` Q. And you were able to isolate the beta
` subunit for -- for the first protein?
` A. HCG.
` Q. Were you able to isolate the cDNA for
` luteinizing hormone?
` A. I did not do that.
` Q. Did you attempt to do that?
` A. I did not attempt to do that.
` Q. Okay. Were you able to isolate the cDNA
` for FSH?
` A. I did not attempt to do that.
` Q. And you were able to isolate the cDNA
` for TSH?
` A. I did not attempt to do that.
` Q. Okay. At any point during your post doc
` at U.C.S.F. had you considered expressing any of the
` proteins we've been discussing in a recombinant
` system?
` MR. BRAUSA: Objection.
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` THE WITNESS: My focus at that time was
` on understanding gene structure, evolution of genes
` and features like that.
` BY MR. McCORMICK:
` Q. Fair enough.
` After your post doc you went to Cold
` Spring Harbor?
` A. That is correct.
` Q. And you were there from 1980 until the
` beginning of 1983?
` A. That is correct.
` Q. I'd just like to talk to you about the
` work you did at Cold Spring Harbor.
` While you were there you worked on -- on
` proteins called human chorionic gonadotropin,
` correct?
` A. hCG that we've already discussed.
` Q. And you worked on human luteinizing
` hormone, which we've already discussed?
` A. That is right.
` Q. What was the nature of your work with
` respect to those two proteins while you were at Cold
` Spring Harbor?
` A. The nature of the work was to extend
` what I had been doing as my post doctoral fellowship
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` work and to isolate genomic sequences, encoding the
` alpha subunit and the beta subunits.
` And as a result of that, I was
` successful. I got multiple beta subunit genes
` isolated for hCG and a beta subunit gene isolated
` for HLH.
` Q. Earlier you had said while you were at
` U.C.S.F. you had not attempted to isolate the cDNA
` for LH?
` A. Correct.
` Q. While you were at Cold Spring Harbor did
` you attempt to isolate the cDNA for LH?
` A. I just isolated the gene.
` Q. That --
` A. The gene, the chromosomal gene.
` Q. The genomic DNA?
` A. Yes.
` Q. Other than -- and you had previously
` already isolated the cDNA for hCG, though?
` A. The alpha and the beta subunit, yes.
` Q. Thank you. Yes.
` Other than those two proteins, did you
` work in any other proteins as major part of your
` work there?
` A. I did some minor collaborations, but
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` that was the major focus of my work.
` Q. At any point did you attempt to express
` recombinantly either hCG or HLH while you were at
` Cold Spring Harbor?
` A. I attempted to express the beta subunit
` genes of CG and LH.
` Q. And were you successful in doing that?
` A. I was successful in identifying
` messenger RNA transcripts.
` The goal of the experiment was based on
` the fact that there are multiple chromosomal
` sequences that appear to encode hCG beta subunit,
` and I wanted to ascertain which of these might be
` pseudo genes and which of these might be real genes.
` Q. Did you -- let's break this down. Let's
` start with hCG.
` A. Yeah.
` Q. So, your testimony was -- I'm not trying
` to mischaracterize it.
` A. It's --
` Q. I just want to recall it for myself.
` Your testimony was that you had -- you
` had gotten mRNA transcribed for both the alpha and
` beta subunit of hCG; is that correct?
` MR. BRAUSA: Objection.
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` THE WITNESS: I think that is not what I
` was trying to say.
` The expression experiments that you're
` asking me about now was to determine which of the
` genes encoding the beta subunit of hCG and LH were
` actively expressed.
` And they form a cluster of genes linked
` together in a chromosome. And I was trying to
` understand why there were so many of these genes,
` did they have different functions, were they
` expressed in different conditions or some not real
` genes. So that was the focus of my work, my basic
` research project.
` BY MR. McCORMICK:
` Q. Okay. And I might have misunderstood
` you.
` I thought you testified that -- and
` again let's break these down one by one. For hCG,
` you had attempted to express that protein, the alpha
` and beta subunit in a recombinant system?
` MR. BRAUSA: Objection.
` BY MR. McCORMICK:
` Q. Or you had not?
` A. I had not done that.
` Q. Oh, I'm sorry. That's why I'm confused.
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` Okay. With respect to LH, had you
` attempted at any point while you were at Cold Spring
` Harbor to express the alpha and/or beta subunit of
` that protein in the recombinant system?
` A. Only the beta subunit gene of LH.
` Q. Okay. And how did you go about
` attempting to express the beta subunit gene of LH?
` MR. BRAUSA: Objection.
` THE WITNESS: The approach was to
` transfect mammalian cells with the beta subunit gene
` and look for RNA expression.
` BY MR. McCORMICK:
` Q. And were you successful in -- in finding
` RNA expression?
` A. Yes.
` Q. Did you look at any point to see if the
` RNA was translated into protein?
` A. No. That was not the focus of the
` studies.
` Q. Okay. So just -- just so I'm clear,
` with respect to hCG, you didn't undertake that type
` of work, that type of recombinant expression that
` you did for LH?
` MR. BRAUSA: Objection.
` THE WITNESS: No. I think this has
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` got -- none of the studies that I did were focused
` on expressing hCG or LH in order to get protein
` produced. The studies were all focused on gene
` expression, understanding whether promoters were
` active.
` BY MR. McCORMICK:
` Q. Okay. So, and by gene expression, you
` were just looking for the production of mRNA?
` A. Yes.
` Q. Okay.
` A. And I understand "gene expression" is as
` fairly loose term. In this case I was looking for
` messenger RNA.
` Q. Fine. And maybe we should do some
` nomenclature.
` And throughout the day, you know,
` there's going to be terms that I think -- I'm going
` to have an understanding what I -- what I know I
` mean by it, but I want to make sure that you and I
` are on the same page.
` So, by "expression," when I say
` "expression," and you can understand that to mean
` both transcription and translation into protein?
` A. That sounds good.
` Q. But I do understand your
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` characterization of the work you did at Cold Spring
` Harbor. And thank you.
` After you left Cold Spring Harbor you
` went to a company called California Biotechnology,
` Inc.?
` A. Correct.
` Q. And you were there from January of '83
` until what date?
` A. Nine -- sometime in 1991.
` Q. Okay. And at what point did that
` company become Scios, Inc.?
` A. That was after I left. So, at some
` point after '91 it became Scios.
` Q. And you -- in your declaration, in your
` direct testimony in the IPR proceeding, you say that
` the primary interest of California Biotechnology was
` in applying recombinant DNA technologies to the
` production of theoretically useful proteins?
` A. That sounds accurate.
` Q. And they were -- they were already in
` that business before you got there in January of
` 1983?
` MR. BRAUSA: Objection.
` THE WITNESS: No
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