`194
`Case: 1:16-cv-00651 Document #: 137 Filed: 08/07/18 Page 1 of 86 PageID #:5230
`
`IN THE UNITED STATES DISTRICT COURT
`NORTHERN DISTRICT OF ILLINOIS
`EASTERN DIVISION
`
`Docket Nos. 16 C 651
` 17 C 7903
`
`Chicago, Illinois
`July 17, 2018
`10:23 a.m.
`
`)))))))))
`
`HOSPIRA, INC.,
`
`Plaintiff,
`
`vs.
`
`FRESENIUS KABI USA, LLC,
`
`Defendant.
`
`VOLUME 2A
`TRANSCRIPT OF PROCEEDINGS - Bench Trial
`BEFORE THE HONORABLE REBECCA R. PALLMEYER
`
`APPEARANCES:
`
`For the Plaintiff:
`
`For the Defendant:
`
`Also Present:
`
`JENNER & BLOCK LLP
`BY: MR. BRADFORD P. LYERLA
`MR. YUSUF ESAT
`MR. AARON A. BARLOW
`MR. REN-HOW H. HARN
`MS. SARA T. HORTON
`353 North Clark Street
`Chicago, Illinois 60654
`
`SCHIFF HARDIN LLP
`BY: MR. IMRON T. ALY
`MR. JOEL M. WALLACE
`MS. TARA L. KURTIS
`MR. KEVIN M. NELSON
`233 South Wacker Drive, Suite 6600
`Chicago, Illinois 60606
`
`SCHIFF HARDIN LLP
`BY: MR. AHMED M.T. RIAZ
`666 Fifth Avenue, 17th Floor
`New York, New York 10103
`
`Mr. Michael P. Bauer, Hospira
`Mr. Ryan Daniel, Fresenius Kabi
`Mr. Ali Ahmed, Fresenius Kabi
`
`1 2 3 4 5 6 7 8 9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`
`
`
`195
`Case: 1:16-cv-00651 Document #: 137 Filed: 08/07/18 Page 2 of 86 PageID #:5231
`
`Court Reporter:
`
`FRANCES WARD, CSR, RPR, RMR, FCRR
`Official Court Reporter
`219 S. Dearborn Street, Suite 2144D
`Chicago, Illinois 60604
`(312) 435-5561
`frances_ward@ilnd.uscourts.gov
`
`1 2 3 4 5 6 7 8 9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`
`
`Cedergren - direct by Wallace
`196
`Case: 1:16-cv-00651 Document #: 137 Filed: 08/07/18 Page 3 of 86 PageID #:5232
`
`MR. WALLACE: Good morning, your Honor.
`
`Joel Wallace on behalf of Fresenius Kabi.
`
`We are calling adversely Dr. Robert Cedergren, one
`
`of the inventors of the patents-in-suit.
`
`THE COURT: Okay.
`
`Sir, can I ask you to raise your right hand.
`
`ROBERT CEDERGREN, DEFENDANT'S ADVERSE WITNESS, SWORN
`
`DIRECT EXAMINATION
`
`BY MR. WALLACE:
`
`Q.
`
`A.
`
`Q.
`
`Good morning, Dr. Cedergren.
`
`Good morning.
`
`Can you please state your full name and address for the
`
`record.
`
`A.
`
`Robert Cedergren, 310 Cyprus Lane, Libertyville,
`
`Illinois.
`
`Q.
`
`And you received your undergraduate degree from the
`
`University of Illinois, correct?
`
`A.
`
`Q.
`
`A.
`
`Q.
`
`A.
`
`Q.
`
`Yes.
`
`And that was a bachelor's of science?
`
`Yes.
`
`And that was 1988, correct?
`
`Correct.
`
`Okay. And then after you received your bachelor's of
`
`science, you went to work for Baxter, correct?
`
`A.
`
`Correct.
`
`1 2 3 4 5 6 7 8 9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`
`
`Cedergren - direct by Wallace
`197
`Case: 1:16-cv-00651 Document #: 137 Filed: 08/07/18 Page 4 of 86 PageID #:5233
`
`Q.
`
`And Baxter is a pharmaceutical company here in the
`
`Chicago area?
`
`A.
`
`Q.
`
`Yes.
`
`And at Baxter, you worked on the research and
`
`development of injectable drug products, correct?
`
`A.
`
`Q.
`
`A.
`
`Q.
`
`A.
`
`Q.
`
`Yes.
`
`And how long did you work there?
`
`About three years.
`
`Okay. So after -- so from about 1988 to about 1991?
`
`Correct.
`
`So after leaving Baxter, then you went into a Ph.D.
`
`program, correct?
`
`A.
`
`Q.
`
`A.
`
`Q.
`
`A.
`
`Q.
`
`A.
`
`Q.
`
`A.
`
`Q.
`
`Yes.
`
`And where was that?
`
`Michigan State University.
`
`Okay. Did you complete that program?
`
`Yes.
`
`And when did you receive your Ph.D.?
`
`1996.
`
`And that program was in biochemistry; is that correct?
`
`Yes.
`
`Okay. So after receiving your Ph.D. in biochemistry,
`
`then you went to work at Abbott Laboratories, right?
`
`A.
`
`Q.
`
`Yes.
`
`And you also started in 1996 there?
`
`1 2 3 4 5 6 7 8 9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`
`
`Cedergren - direct by Wallace
`198
`Case: 1:16-cv-00651 Document #: 137 Filed: 08/07/18 Page 5 of 86 PageID #:5234
`
`A.
`
`Q.
`
`At the end of 1996, correct.
`
`Okay. Thank you.
`
`At first you worked in the diagnostics division of
`
`Abbott Laboratories?
`
`A.
`
`Q.
`
`Correct.
`
`And you worked there for about one-and-a-half years; is
`
`that right?
`
`A.
`
`Q.
`
`Yes.
`
`And then you moved to the hospital products division
`
`within Abbott, correct?
`
`A.
`
`Q.
`
`Yes.
`
`And within the hospital products division, you performed
`
`analytical support for formulations and product development,
`
`correct?
`
`A.
`
`Q.
`
`Yes.
`
`And you continued working in the hospital products
`
`division all the way through when it was split off from
`
`Abbott, correct?
`
`A.
`
`Q.
`
`Yes.
`
`And then you were one of the employees that picked up
`
`and moved over to Hospira, right?
`
`A.
`
`Q.
`
`A.
`
`Q.
`
`Yes.
`
`And that was in 2004?
`
`Yes.
`
`Okay. And in 2004 -- I'm sorry.
`
`1 2 3 4 5 6 7 8 9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`
`
`Cedergren - direct by Wallace
`199
`Case: 1:16-cv-00651 Document #: 137 Filed: 08/07/18 Page 6 of 86 PageID #:5235
`
`In 2005, you then became a senior group leader at
`
`Hospira, correct?
`
`A.
`
`Q.
`
`Yes.
`
`And you continued your work in formulation -- or in the
`
`analytical department, supporting formulation and product
`
`development, correct?
`
`A.
`
`Q.
`
`Yes.
`
`Okay. So in about 2006, you were assigned the task of
`
`working on the dexmedetomidine molecule at Hospira, correct?
`
`A.
`
`Q.
`
`Correct.
`
`And at the time you began working on dexmedetomidine,
`
`you had had your Ph.D. and more than ten years of experience
`
`within the pharmaceutical industry, right?
`
`A.
`
`Q.
`
`Yes.
`
`And then you ended up leaving Hospira near the end of
`
`2008, correct?
`
`A.
`
`Q.
`
`Yes.
`
`So whatever work you did on dexmedetomidine, your work
`
`was done by the end of 2008, right?
`
`A.
`
`Q.
`
`Yes.
`
`And you understand that there were patents filed based
`
`on some of the data that was done by Hospira for the
`
`dexmedetomidine product?
`
`A.
`
`Q.
`
`Yes.
`
`And you understand those were filed in January of 2012?
`
`1 2 3 4 5 6 7 8 9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`
`
`Cedergren - direct by Wallace
`200
`Case: 1:16-cv-00651 Document #: 137 Filed: 08/07/18 Page 7 of 86 PageID #:5236
`
`A.
`
`Q.
`
`I can't say exactly when they were filed.
`
`If they were filed in January of 2012, that's more than
`
`three years after you left the company, right?
`
`A.
`
`Q.
`
`Correct.
`
`Now, you left Hospira and you went to work for Zoetis,
`
`correct?
`
`THE COURT: For what?
`
`MR. WALLACE: Zoetis.
`
`THE COURT: Can you spell that?
`
`THE WITNESS: Actually, I went to work for Abbott
`
`again, Abbott's animal health division.
`
`THE COURT: Oh, Abbott. Okay.
`
`BY MR. WALLACE:
`
`Q.
`
`And then you went -- and then eventually you went to
`
`Zoetis?
`
`A.
`
`That division was sold to Zoetis, Z-o-e-t-i-s.
`
`THE COURT: I'm sorry. What?
`
`THE WITNESS: Z-o-e-t-i-s.
`
`THE COURT: Z-o-e-t-i-s. Okay. Got it. Thank
`
`you.
`
`BY MR. WALLACE:
`
`Q.
`
`A.
`
`Q.
`
`A.
`
`And Zoetis, that's a veterinary products company?
`
`Correct.
`
`And Zoetis has a dexmedetomidine product also, correct?
`
`I believe they do.
`
`1 2 3 4 5 6 7 8 9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`
`
`Cedergren - direct by Wallace
`201
`Case: 1:16-cv-00651 Document #: 137 Filed: 08/07/18 Page 8 of 86 PageID #:5237
`
`Q.
`
`A.
`
`Q.
`
`And have you ever worked on that product at Zoetis?
`
`No.
`
`Okay.
`
`THE COURT: Are you still employed at Zoetis?
`
`THE WITNESS: Yes.
`
`THE COURT: Okay. Thank you.
`
`BY MR. WALLACE:
`
`Q.
`
`A.
`
`Q.
`
`That's also out in the Chicago suburbs, correct?
`
`I work from the Chicago suburbs. I work remotely.
`
`So in 2006, you start your work on the dexmedetomidine
`
`product, right?
`
`A.
`
`Q.
`
`Yes.
`
`And your boss comes to you in 2006, and the instructions
`
`you were given from management were to develop a premix
`
`injectable formulation of dexmedetomidine, correct?
`
`A.
`
`Q.
`
`Yes.
`
`And by "premix product," they meant a product that was
`
`ready to use, right?
`
`A.
`
`Q.
`
`Correct.
`
`And so management came to you and said, we want a
`
`ready-to-use formulation of dexmedetomidine, right?
`
`A.
`
`Q.
`
`Yes.
`
`And you don't know who at Hospira had the idea to
`
`formulate the ready-to-use dexmedetomidine product, right?
`
`A.
`
`I don't recall.
`
`1 2 3 4 5 6 7 8 9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`
`
`Cedergren - direct by Wallace
`202
`Case: 1:16-cv-00651 Document #: 137 Filed: 08/07/18 Page 9 of 86 PageID #:5238
`
`Q.
`
`And in order to meet the goal of having a ready-to-use
`
`dexmedetomidine product, the concentration of dexmedetomidine
`
`in that product you were to make had to match the
`
`concentration that was used in the old product when it was
`
`actually given to patients, correct?
`
`A.
`
`Q.
`
`That was the goal, yes.
`
`And the information about what concentration is given to
`
`patients, that would be available in the label for Precedex
`
`concentrate, right?
`
`A.
`
`Q.
`
`Correct.
`
`And as part of your development work, you looked at the
`
`Precedex concentrate label, correct?
`
`A.
`
`Q.
`
`I probably did, correct.
`
`When used in patients, the Precedex concentrate is
`
`diluted to 4 micrograms per milliliter, right?
`
`A.
`
`Q.
`
`Yes.
`
`And that was -- the goal of your project was to create a
`
`new product that also had a concentration of
`
`4 micrograms per milliliter of dexmedetomidine, correct?
`
`A.
`
`Q.
`
`Yes.
`
`Now, Dr. Cedergren, you remember being deposed by me
`
`about a year-and-a-half ago, in November of 2016, correct?
`
`A.
`
`Q.
`
`Yes.
`
`And at that time we talked about the work that you did
`
`on the dexmedetomidine project?
`
`1 2 3 4 5 6 7 8 9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`
`
`Cedergren - direct by Wallace
`203
`Case: 1:16-cv-00651 Document #: 137 Filed: 08/07/18 Page 10 of 86 PageID #:5239
`
`A.
`
`Q.
`
`Yes.
`
`And we talked about meetings you attended as part of
`
`that project?
`
`A.
`
`Q.
`
`Yes.
`
`And you told me about presentations that you gave about
`
`dexmedetomidine within the company, right?
`
`A.
`
`Q.
`
`I believe so.
`
`Okay.
`
`Now, counsel for Hospira has represented that you
`
`don't remember what you did.
`
`So is that true, that today you now don't know what
`
`happened at Hospira?
`
`A.
`
`I don't remember specifics of these meetings and
`
`presentations.
`
`Q.
`
`Okay. So the work that you did on dexmedetomidine, that
`
`wasn't memorable, as far as your career goes?
`
`A.
`
`Q.
`
`I don't remember specifics, no.
`
`Because it was just routine work that you typically did
`
`in the analytical department at Hospira, right?
`
`A.
`
`I don't know if I would say typical, but I worked on a
`
`lot of projects.
`
`Q.
`
`Now, the reason that you wanted to make a ready-to-use
`
`version of dexmedetomidine was to make the product more
`
`convenient for physicians and patients, correct?
`
`A.
`
`Yes.
`
`1 2 3 4 5 6 7 8 9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`
`
`Cedergren - direct by Wallace
`204
`Case: 1:16-cv-00651 Document #: 137 Filed: 08/07/18 Page 11 of 86 PageID #:5240
`
`Q.
`
`And when you began your work on that product in 2006,
`
`you understood that if you were successful, then the product
`
`would be more convenient for physicians, correct?
`
`A.
`
`Q.
`
`Yes.
`
`And before 2012, it was known that taking a concentrated
`
`product, putting it in a premix formulation, that would make
`
`the formulation easier to administer for physicians, right?
`
`A.
`
`Q.
`
`Yes.
`
`And, in fact, it was common sense that, if they don't
`
`have to do the dilution step, it would be easier for
`
`physicians to use, right?
`
`A.
`
`Q.
`
`Yes.
`
`And it was common sense that, if they don't have to do
`
`the dilution step, physicians will save time, right?
`
`A.
`
`Q.
`
`I'm sorry. Could you repeat that?
`
`Sure.
`
`It was common sense that, if physicians don't have
`
`to do the dilution step, they will save time?
`
`A.
`
`Q.
`
`Correct.
`
`And that understanding, that wasn't based on internal
`
`secret Hospira documents, right?
`
`A.
`
`Q.
`
`A.
`
`Q.
`
`I don't recall.
`
`It was common sense to you?
`
`Yes.
`
`So your bosses come to you in 2006 and said, we need you
`
`1 2 3 4 5 6 7 8 9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`
`
`Cedergren - direct by Wallace
`205
`Case: 1:16-cv-00651 Document #: 137 Filed: 08/07/18 Page 12 of 86 PageID #:5241
`
`to make a premix dexmedetomidine. And so now your team's job
`
`was to come up with a container, right?
`
`A.
`
`Q.
`
`A container and a formulation.
`
`And the first thing that Hospira thought of were plastic
`
`containers, syringes, and glass vials, right?
`
`A.
`
`Q.
`
`I believe so.
`
`And Hospira proposed -- before they could get the
`
`product going, they had to make a proposal of these products
`
`to the management to get the funding; is that right?
`
`A.
`
`Q.
`
`I don't recall.
`
`Okay. You helped develop a concept proposal for the
`
`ready-to-use dexmedetomidine product?
`
`A.
`
`Q.
`
`I believe so.
`
`And in general, glass is used in the development of
`
`pharmaceutical products as storage containers because, absent
`
`evidence to the contrary, the assumption is that it will be
`
`nonreactive, correct?
`
`A.
`
`Q.
`
`Correct.
`
`I want to bring up JTX72, if we could. It's in your
`
`binder. Also it's on your screen, whichever you prefer,
`
`Dr. Cedergren.
`
`Now, this is the product development concept
`
`proposal dated September 22nd, 2006.
`
`Do you see that, Dr. Cedergren?
`
`A.
`
`Yes.
`
`1 2 3 4 5 6 7 8 9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`
`
`Cedergren - direct by Wallace
`206
`Case: 1:16-cv-00651 Document #: 137 Filed: 08/07/18 Page 13 of 86 PageID #:5242
`
`Q.
`
`A.
`
`Q.
`
`A.
`
`Q.
`
`Do you see your name on the front page here?
`
`Yes.
`
`And you represent the R&D group?
`
`Yes.
`
`And this proposal, this was prepared by many units
`
`within the Hospira team, correct?
`
`A.
`
`Q.
`
`A.
`
`Q.
`
`Correct.
`
`Now, this is called "Precedex Line Extension."
`
`Do you see that?
`
`Yes.
`
`And "line extension" means creating a new product with
`
`the same drug, right?
`
`A.
`
`Q.
`
`In this case, yeah.
`
`And your understanding was that Hospira wanted to create
`
`a new product with dexmedetomidine because it would be more
`
`convenient, right?
`
`A.
`
`Q.
`
`Yes.
`
`So I think that's even spelled out in the document.
`
`MR. WALLACE: If we could, look at Page 2, and look
`
`at the customer needs, "Defining Customer Needs." I think
`
`it's down another box, please. There you are.
`
`BY MR. WALLACE:
`
`Q.
`
`So the key customer needs for this project proposal,
`
`according to the box on the right there, was that it would
`
`reduce the inconvenience the hospitals are faced with by the
`
`1 2 3 4 5 6 7 8 9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`
`
`Cedergren - direct by Wallace
`207
`Case: 1:16-cv-00651 Document #: 137 Filed: 08/07/18 Page 14 of 86 PageID #:5243
`
`need for their pharmacy department to dilute the product,
`
`right?
`
`A.
`
`Q.
`
`Yes.
`
`And at that time, that was a barrier to growth for the
`
`Precedex product, according to --
`
`A.
`
`Q.
`
`According to this document.
`
`You don't have any reason to doubt what's in this
`
`document, correct?
`
`A.
`
`Q.
`
`No.
`
`Okay. So if we go to the next page, JTX72 at Page 3, we
`
`have the proposals.
`
`These are -- this is the first thoughts that had
`
`come to mind for Hospira, right?
`
`A.
`
`Q.
`
`Yes.
`
`And what's shown here is, we have got two ready-to-use
`
`syringes. We have got three ADD-Vantage products and two
`
`glass containers.
`
`Do you see that?
`
`A.
`
`Q.
`
`Yes.
`
`Okay. The ADD-Vantage, that's a plastic system,
`
`correct?
`
`A.
`
`I'm not sure if it's a glass or plastic vial that's
`
`attached to an IV bag.
`
`Q.
`
`Okay. And the reason those are higher concentrations is
`
`because that's a concentrate that's attached to a bag that's
`
`1 2 3 4 5 6 7 8 9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`
`
`Cedergren - direct by Wallace
`208
`Case: 1:16-cv-00651 Document #: 137 Filed: 08/07/18 Page 15 of 86 PageID #:5244
`
`then diluted sort of at the site; is that correct?
`
`A.
`
`Q.
`
`Yes.
`
`So that's not a ready-to-use product. That's something
`
`that requires dilution?
`
`A.
`
`Q.
`
`Yes.
`
`And you don't know who came up with these ideas, right,
`
`Dr. Cedergren?
`
`A.
`
`Q.
`
`I don't recall.
`
`I want to turn to Page 4 of this document. I want to
`
`look at the IP at the bottom, "Competitive Overview."
`
`So at this time, Precedex was unique within the
`
`sedative market; is that right, Dr. Cedergren?
`
`A.
`
`Q.
`
`According to this document.
`
`And it was unique because it was the only drug that was
`
`being promoted at this time; is that right, Dr. Cedergren?
`
`A.
`
`Q.
`
`A.
`
`Q.
`
`Does it say that in this document?
`
`Do you know that?
`
`I don't know.
`
`Okay. This was Hospira's only branded product at that
`
`time, though, correct?
`
`A.
`
`Q.
`
`As far as I remember.
`
`So it was very important to keep this franchise extended
`
`as long as possible, right?
`
`A.
`
`I'm not sure about that.
`
`MR. WALLACE: Okay. I want to look at the
`
`1 2 3 4 5 6 7 8 9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`
`
`Cedergren - direct by Wallace
`209
`Case: 1:16-cv-00651 Document #: 137 Filed: 08/07/18 Page 16 of 86 PageID #:5245
`
`competitive environment, if we could, Mr. Haw. It's in the
`
`middle of the -- there we go.
`
`BY MR. WALLACE:
`
`Q.
`
`And at this time it was seen that dexmedetomidine was
`
`competing against these other products.
`
`Do you see that?
`
`Yes.
`
`And those are midazolam, lorazepam, and propofol?
`
`Yes.
`
`And those were the other sedatives that were on the
`
`A.
`
`Q.
`
`A.
`
`Q.
`
`market at this time; is that right?
`
`A.
`
`Q.
`
`According to this document.
`
`Okay. Now I want to look at Page 5. There is a
`
`technology assessment here.
`
`And the technology assessment, was that something
`
`that your group would have worked on, R&D?
`
`A.
`
`Q.
`
`I don't recall specifically.
`
`Okay. And so what's being shown here in the technology
`
`assessment was Hospira's thinking about the potential
`
`problems or issues that might arise from each of the proposed
`
`containers.
`
`Do you see that, Dr. Cedergren?
`
`A.
`
`Q.
`
`Yes.
`
`So first we have flex premix.
`
`Do you see that?
`
`1 2 3 4 5 6 7 8 9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`
`
`Cedergren - direct by Wallace
`210
`Case: 1:16-cv-00651 Document #: 137 Filed: 08/07/18 Page 17 of 86 PageID #:5246
`
`A.
`
`Q.
`
`A.
`
`Q.
`
`Yes.
`
`And that's a plastic bag, right?
`
`Yes.
`
`And for plastic bags, there was concern about absorption
`
`of dexmedetomidine, right?
`
`A.
`
`Q.
`
`Yes.
`
`And that was because dexmedetomidine is a lipophilic
`
`compound, right?
`
`A.
`
`Q.
`
`Correct.
`
`So could you explain briefly what a lipophilic compound
`
`means.
`
`THE COURT: You know what? I am going to ask you
`
`to spell that, too.
`
`THE WITNESS: L-i-p-o-p-h-i-l-i-c.
`
`THE COURT: Okay. Lipophilic. Thanks.
`
`MR. WALLACE: From the Greek "lipo" for the fat and
`
`"philic," like.
`
`THE COURT: Got it.
`
`BY MR. WALLACE:
`
`Q.
`
`A.
`
`Q.
`
`What does lipophilic mean, Dr. Cedergren?
`
`It is -- it likes nonpolar solvents.
`
`And nonpolar solvent, that would be like plastic,
`
`correct?
`
`A.
`
`Q.
`
`Yes.
`
`So it prefers plastic over water.
`
`1 2 3 4 5 6 7 8 9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`
`
`Cedergren - direct by Wallace
`211
`Case: 1:16-cv-00651 Document #: 137 Filed: 08/07/18 Page 18 of 86 PageID #:5247
`
`Is that how it's normally defined?
`
`A.
`
`Q.
`
`Well, it depends on the salt form or the formulation.
`
`Sure. But if dexmedetomidine is lipophilic, it's more
`
`likely to interact with plastic containers. Is that fair?
`
`A.
`
`If it was truly lipophilic, yes.
`
`THE COURT: I'm sorry to do this.
`
`Tell me what you mean by a nonpolar solvent.
`
`THE WITNESS: Solvents that aren't water. Water is
`
`polar, and a nonpolar solvent would be a solvent like a
`
`hexane or something like that.
`
`THE COURT: "Polar" is the word for water?
`
`THE WITNESS: Water is very polar. It's very
`
`polar.
`
`THE COURT: Oh, so there could be something else
`
`that's polar, but water is known to be very polar.
`
`THE WITNESS: Right.
`
`THE COURT: All right. Thank you.
`
`BY MR. WALLACE:
`
`Q.
`
`So the next container that's discussed here is
`
`ADD-Vantage.
`
`Do you see that, Dr. Cedergren?
`
`Yes.
`
`And we see in the -- I don't know -- fourth bullet point
`
`A.
`
`Q.
`
`there is a discussion about, that this would be needed
`
`because there is still -- the issue that the ADD-Vantage
`
`1 2 3 4 5 6 7 8 9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`
`
`Cedergren - direct by Wallace
`212
`Case: 1:16-cv-00651 Document #: 137 Filed: 08/07/18 Page 19 of 86 PageID #:5248
`
`vials are connected to PVC bags, right?
`
`A.
`
`Q.
`
`Yes.
`
`And so that would still have the possible concern of
`
`absorption onto the plastic bag.
`
`That was a concern within Hospira?
`
`A.
`
`Q.
`
`A.
`
`Q.
`
`Yes.
`
`And then we see "Syringe For Use in Syringe Pumps."
`
`Do you see that heading?
`
`Yes.
`
`And then for syringes, again we have the issue that
`
`there is possible absorption, right, for the Ansyr syringes?
`
`A.
`
`Q.
`
`Yes, that's what it says.
`
`And the Ansyr syringes, that's another polymer syringe,
`
`correct?
`
`A.
`
`Q.
`
`Yes.
`
`And that was a type of syringe that was proprietary to
`
`Hospira at the time?
`
`A.
`
`Q.
`
`I'm not sure.
`
`Okay. That's fair.
`
`But in the second bullet point, it says that if
`
`Ansyr syringes are not feasible, referring to the potential
`
`for absorption, then they would switch to glass syringes.
`
`Do you see that?
`
`Yes.
`
`And so the thought was that if plastic doesn't work, a
`
`A.
`
`Q.
`
`1 2 3 4 5 6 7 8 9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`
`
`Cedergren - direct by Wallace
`213
`Case: 1:16-cv-00651 Document #: 137 Filed: 08/07/18 Page 20 of 86 PageID #:5249
`
`glass syringe is more likely to work. Is that fair?
`
`A.
`
`I don't know if it's more likely, but it's another
`
`option.
`
`Q.
`
`It's another option.
`
`Now, we see "Glass Premix" is the next entry.
`
`Do you see that?
`
`Yes.
`
`And in September of 2006, within Hospira, you foresaw no
`
`A.
`
`Q.
`
`major issues with glass premix, correct?
`
`A.
`
`Q.
`
`That's what the document states, yes.
`
`And this is the only proposed container for which there
`
`are no major issues predicted, correct, Dr. Cedergren?
`
`A.
`
`Q.
`
`That's what it appears.
`
`And at this point it was understood that premix -- when
`
`it says "glass premix" -- that referred to the
`
`4 micrograms-per-milliliter concentration of dexmedetomidine?
`
`A.
`
`Q.
`
`Yes.
`
`So this September 2006 document was the first place that
`
`it was proposed that a concentration of dexmedetomidine at
`
`4 micrograms per milliliter in a glass container -- is that
`
`accurate? It was the first proposal?
`
`A.
`
`Q.
`
`I'm sorry. Can you repeat the question?
`
`Sure.
`
`In September of 2006, it was proposed to place that
`
`concentration, 4 micrograms per milliliter, in glass
`
`1 2 3 4 5 6 7 8 9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`
`
`Cedergren - direct by Wallace
`214
`Case: 1:16-cv-00651 Document #: 137 Filed: 08/07/18 Page 21 of 86 PageID #:5250
`
`containers. Is that accurate?
`
`A.
`
`Q.
`
`That's one of the options presented.
`
`Okay. Now we want to look the last box on that page,
`
`the "Other Needed Capabilities."
`
`Do you see this?
`
`MR. WALLACE: And if we could also have this bridge
`
`over to the next page as well.
`
`BY MR. WALLACE:
`
`Q.
`
`Again, this is a discussion of the -- on the second
`
`bullet point, those Ansyr syringes.
`
`Do you see that?
`
`A.
`
`Yes.
`
`MR. WALLACE: The bullet point, for the record, is
`
`on Page 6 of JTX72.
`
`BY MR. WALLACE:
`
`Q.
`
`There were concerns about plastic absorption with the
`
`Ansyr syringes, correct?
`
`That's what we saw above?
`
`A.
`
`Q.
`
`Correct.
`
`And so if they can't use plastic, then the option for
`
`Hospira is, they are going to have to go buy glass syringes,
`
`correct?
`
`A.
`
`Q.
`
`That's what it states.
`
`Okay. I want to look down on the same page, 6. We have
`
`some -- there were the four configurations.
`
`1 2 3 4 5 6 7 8 9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`
`
`Cedergren - direct by Wallace
`215
`Case: 1:16-cv-00651 Document #: 137 Filed: 08/07/18 Page 22 of 86 PageID #:5251
`
`So again, we have -- there is only really two
`
`options here.
`
`There is glass containers or plastic containers,
`
`right, Dr. Cedergren?
`
`A.
`
`Q.
`
`Correct.
`
`And for these specific configurations, you don't know
`
`who came up with these, right?
`
`A.
`
`I don't recall specifically who came up with each
`
`option.
`
`Q.
`
`Okay. So as of September 2006, it was thought that a
`
`glass syringe would present fewer issues with compatibility
`
`than an Ansyr plastic syringe?
`
`A.
`
`Q.
`
`That's what it states.
`
`And each of the presentations that were proposed within
`
`Hospira, those were containers that had already been used in
`
`a pharmaceutical product in the United States previously,
`
`correct?
`
`A.
`
`Q.
`
`As far as I know.
`
`And to look at the No. 1 bullet point, it's talking
`
`about 50 milliliters and 100 milliliters.
`
`Do you see that?
`
`Yes.
`
`How were those volumes chosen?
`
`I don't know specifically how they were chosen.
`
`Okay. But these were standard-size glass containers,
`
`A.
`
`Q.
`
`A.
`
`Q.
`
`1 2 3 4 5 6 7 8 9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`
`
`Cedergren - direct by Wallace
`216
`Case: 1:16-cv-00651 Document #: 137 Filed: 08/07/18 Page 23 of 86 PageID #:5252
`
`correct?
`
`A.
`
`They are typical sizes.
`
`MR. WALLACE: I want to do a side-by-side, if we
`
`can, here of JTX72, this document, Page 6, these proposals;
`
`and on the other side, JTX2, which is the '049 patent.
`
`BY MR. WALLACE:
`
`Q.
`
`Do you understand the '049 patent is one of the patents
`
`in which you are named as an inventor?
`
`A.
`
`Q.
`
`Yes.
`
`Okay. And I just want to make sure that we are on the
`
`same page here.
`
`So you have patented -- or you have offered your
`
`name to a patent that says "a ready-to-use liquid
`
`pharmaceutical composition."
`
`That's the premix, correct? That's the glass
`
`premix?
`
`A.
`
`Q.
`
`Yes.
`
`And the Claim 1 says that it's for parenteral
`
`administration.
`
`And you understood at that time was that Precedex
`
`was administered parenterally, correct?
`
`A.
`
`Q.
`
`Yes.
`
`And the range or the concentration of dexmedetomidine in
`
`the claim is .005 to about 50 micrograms per milliliter.
`
`Do you see that?
`
`1 2 3 4 5 6 7 8 9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`
`
`Cedergren - direct by Wallace
`217
`Case: 1:16-cv-00651 Document #: 137 Filed: 08/07/18 Page 24 of 86 PageID #:5253
`
`A.
`
`Q.
`
`Yes.
`
`So the proposal in 2006 was to make a
`
`4 micrograms-per-milliliter product, correct?
`
`A.
`
`Q.
`
`Yes.
`
`In the claim it says it's supposed to be disposed within
`
`a sealed glass container.
`
`Do you see that?
`
`A.
`
`Q.
`
`Yes.
`
`And the proposal here, No. 1, was to put the product in
`
`a glass container, correct?
`
`A.
`
`Q.
`
`A.
`
`Q.
`
`Yes.
`
`And that glass container would need to be sealed?
`
`Yes.
`
`And then the final element here is the pH.
`
`Now, the pH of dexmedetomidine in water, it's
`
`between 2 and 10, correct?
`
`A.
`
`Q.
`
`I don't recall what the pH is.
`
`But the pH, that would be something that you would see
`
`on the label, correct?
`
`A.
`
`Q.
`
`I'm not sure if it's on the label or not.
`
`Okay.
`
`Have you ever formulated a product that had a pH of
`
`lower than 2, Dr. Cedergren?
`
`A.
`
`Q.
`
`Not that I recall.
`
`Have you ever formulated a product with a pH of above
`
`1 2 3 4 5 6 7 8 9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`
`
`Cedergren - direct by Wallace
`218
`Case: 1:16-cv-00651 Document #: 137 Filed: 08/07/18 Page 25 of 86 PageID #:5254
`
`10?
`
`A.
`
`Q.
`
`Not that I recall.
`
`And that's because, as you get to the extremes, those
`
`would be dangerous to administer to a patient, correct?
`
`A.
`
`Q.
`
`I can't say that.
`
`Now, Precedex premix, the ready-to-use product, that was
`
`not the first ready-to-use product available on the market,
`
`right?
`
`A.
`
`Q.
`
`I don't believe so.
`
`And it's not the first product on the market to use
`
`dexmedetomidine, right?
`
`A.
`
`Q.
`
`No.
`
`And it's not the first product even that would be used
`
`using dexmedetomidine at 4 micrograms per milliliter,
`
`correct?
`
`A.
`
`Q.
`
`A.
`
`Q.
`
`After dilution?
`
`Sure.
`
`Correct.
`
`And the old product, the Precedex concentrate product,
`
`that was sold in a sealed glass container also, wasn't it,
`
`Dr. Cedergren?
`
`A.
`
`Q.
`
`I believe so.
`
`And that was -- I am going to move on.
`
`Now, testing stoppers for extractables, that's a
`
`routine pharmaceutical development work, right?
`
`1 2 3 4 5 6 7 8 9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`
`
`Cedergren - direct by Wallace
`219
`Case: 1:16-cv-00651 Document #: 137 Filed: 08/07/18 Page 26 of 86 PageID #:5255
`
`A.
`
`Q.
`
`It's typically done.
`
`And container compatibility studies are a routine part
`
`of pharmaceutical development work with injectable products?
`
`A.
`
`Q.
`
`It's typically done.
`
`And component compatibility studies are a routine part
`
`of pharmaceutical work with injectable products, correct?
`
`A.
`
`Q.
`
`It's typically done.
`
`Okay.
`
`Now, the type of glass you ultimately chose -- or
`
`that was experimented on for the dexmedetomidine premix
`
`project was Type 1 glass, correct?
`
`A.
`
`Q.
`
`I don't exactly recall which type.
`
`In your experience, is Type 1 glass the least reactive
`
`type of glass for liquid pharmaceutical products?
`
`A.
`
`Q.
`
`Yes.
`
`And so if there were a concern about the stability of a
`
`product, the logical choice would be to use Type 1 glass,
`
`correct?
`
`A.
`
`Q.
`
`Yes.
`
`And coated stoppers are typically used in the
`
`pharmaceutical industry for injectable products, correct,
`
`Dr. Cedergren?
`
`A.
`
`Q.
`
`A.
`
`Did you say they are typically used?
`
`Yes.
`
`I don't know how typical the products are.
`
`1 2 3 4 5 6 7 8 9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`
`
`Cedergren - direct by Wallace
`220
`Case: 1:16-cv-00651 Document #: 137 Filed: 08/07/18 Page 27 of 86 PageID #:5256
`
`Q.
`
`A.
`
`Q.
`
`Sure. Have you used coated stoppers, Dr. Cedergren?
`
`Yes.
`
`And the reason one would use a coated stopper is to
`
`prevent interaction between the formulation and the stopper,
`
`correct?
`
`A.
`
`Q.
`
`Correct.
`
`And so if one were concerned about stability of a
`
`product, a formulator or someone who works in the
`
`pharmaceutical industry would choose a coated stopper,
`
`correct?
`
`A.
`
`Q.
`
`Yes.
`
`I want to turn to DTX90. And this is a document
`
`entitled "Precedex Lifecycle Management Strategy Session."
`
`Do you see that, Dr. Cedergren?
`
`Yes.
`
`And that was dated November 7th, 2006.
`
`Do you see that?
`
`Yes.
`
`And we talked about this at the deposition, but this was
`
`A.
`
`Q.
`
`A.
`
`Q.
`
`a presentation that you were at, right, Dr. Cedergren?
`
`A.
`
`If my name is on here, then, I suppose I was. I don't
`
`recall being there, but --
`
`Q.
`
`So this moves us ahead a little bit.
`
`We had the proposal in September, and now we are
`
`moving to some sort of presentation in November, which is
`
`1 2 3 4 5 6 7 8 9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`
`
`Cedergren - direct by Wallace
`221
`Case: 1:16-cv-00651 Document #: 137 Filed: 08/07/18 Page 28 of 86 PageID #:5257
`
`sort of fast-forwarded a few months; is that right?
`
`A.
`
`Q.
`
`Okay. Sure.
`
`Now let's turn to Page 5 of this document.
`
`We have "LCM" at the top. That's Lifecycle
`
`Management, correct?
`
`A.
`
`Q.
`
`Yes.
`
`Okay. And on this slide we have some of the discussion
`
`of why Hospira is engaging in lifecycle management for the
`
`Precedex product, correct, Dr. Cedergren?
`
`A.
`
`Q.
`
`Yes.
`
`And the first point here -- I think we talked about this
`
`before, but it's the only proprietary product for Hospira.
`
`Do you see that?
`
`Yes.
`
`And proprietary product, that means it's their only
`
`A.
`
`Q.
`
`branded product; is that fair?
`
`A.
`
`Q.
`
`Yes.
`
`All the other products Hospira was selling at this time
`
`were generic products, right?
`
`A.
`
`Q.
`
`Correct.
`
`And it says in the second bullet point, there is a large
`
`investment into expanding the label.
`
`Do you see that?
`
`Yes.
`
`Do you know what that was referring to?
`
`A.
`
`Q.
`
`1 2 3 4 5 6 7 8 9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`
`
`Cedergren - direct by Wallace
`222
`Case: 1:16-cv-00651 Document #: 137 Filed: 08/07/18 Page 29 of 86 PageID #:5258
`
`A.
`
`Q.
`
`I wasn't involved in that, no.
`
`That's fair.
`
`Now, the third bullet point here identifies that
`
`the reason for lifecycle management at Hospira was to protect
`
`the market from generic competition when the patent expires.
`
`Do you see that?
`
`Yes.
`
`And the patent that that's talking about is the patent
`
`A.
`
`Q.
`
`on the compound of dexmedetomidine, correct?
`
`A.
`
`Q.
`
`A.
`
`Q.
`
`I assume so. I don't know.
`
`And that was expiring in July 2013, correct?
`
`That's what it states.
`
`So the goal within Hospira was to get a new product on
`
`the market to extend the life of the Precedex product line,
`
`correct?
`
`A.
`
`Q.
`
`I couldn't say that.
`
`It was explained to you that it was important to get a
`
`new product on the market to protect the Precedex brand from
`
`generic competition, right?
`
`A.
`
`Q.
`
`That's what this document says.
`
`And that's the type of information you would have
`
`expected to be communicated to you in this meeting?
`
`A.
`
`Q.
`
`If I was at this meeting,
Accessing this document will incur an additional charge of $.
After purchase, you can access this document again without charge.
Accept $ Charge
Still Working On It
This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.
Give it another minute or two to complete, and then try the refresh button.
A few More Minutes ... Still Working
It can take up to 5 minutes for us to download a document if the court servers are running slowly.
Thank you for your continued patience.
This document could not be displayed.
We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.
Your account does not support viewing this document.
You need a Paid Account to view this document. Click here to change your account type.
Your account does not support viewing this document.
Set your membership
status to view this document.
With a Docket Alarm membership, you'll
get a whole lot more, including:
- Up-to-date information for this case.
- Email alerts whenever there is an update.
- Full text search for other cases.
- Get email alerts whenever a new case matches your search.
One Moment Please
The filing “” is large (MB) and is being downloaded.
Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.
Your document is on its way!
If you do not receive the document in five minutes, contact support at support@docketalarm.com.
Sealed Document
We are unable to display this document, it may be under a court ordered seal.
If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.
Access Government Site
