US Patent and Trademark Office
`_________________________________________
`
`Actavis, LLC
`v.
`Abraxis Bioscience, LLC
`
`CONFIDENTIAL
`
`_________________________________________
`
`Video Deposition of:
`Cory Berkland, Ph.D.
`November 30, 2017
`
`Abraxis EX2070
`Apotex Inc. and Apotex Corp. v. Abraxis Bioscience, LLC
`IPR2018-00151; IPR2018-00152; IPR2018-00153
`
`

`

`US Patent and Trademark Office
`Actavis v. Abraxis
`
`Page 1
`UNITED STATES PATENT AND TRADEMARK OFFICE
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`------------------------------------------
`ACTAVIS LLC,
` Petitioner,
`v.
`ABRAXIS BIOSCIENCE, LLC,
` Patent Owner.
`
`FINAL - CONFIDENTIAL
`Cory Berkland, Nov. 30, 2017
`
`Page 3
`
`APPEARANCES (Cont.)
`
`ATTORNEYS FOR CIPLA LIMITED
` Anil H. Patel, Esquire
` K&L GATES LLP
` 1000 Main Street, Suite 2550
` Houston, Texas 77002
` 1-713-815-7304
`
`ALSO PRESENT
` Patrick Elsevier, Celgene Corporation
`
`JANE ROSE REPORTING
` 74 Fifth Avenue
` New York, New York 10011
` 1-800-825-3341
` Linda S. Kinkade, Court Reporter
` Jason Aqui, Videographer
`
`Case IPR2017-01101
`Case IPR2017-01103
`Case IPR2017-01104
`-------------------------------------------
`
`VIDEO DEPOSITION OF:
`Cory J. Berkland, Ph.D.
`November 30, 2017
`Washington, DC
`Lead: Andrew Chalson, Esquire
`Firm: Quinn Emanuel Urquhart
`
`FINAL COPY - CONFIDENTIAL
`JANE ROSE REPORTING 1-800-825-3341
`
`APPEARANCES
`
`ATTORNEYS FOR PETITIONER
` Charles B. Klein, Esquire
` Sharon Lin, Esquire
` WINSTON & STRAWN LLP
` 1700 K Street, NW
` Washington, DC 20006
` 1-202-282-5977
`
`ATTORNEYS FOR PATENT OWNER
` Andrew S. Chalson, Esquire
` Daniel Wiesner, Esquire
` QUINN EMANUEL URQUHART & SULLIVAN
` 51 Madison Avenue
` New York, New York 10010
` 1-212-849-7000
`
` Christopher J. Harnett, Esquire
` JONES DAY
` 250 Vesey Street
` New York, New York 10281
` 1-212-326-3939
`
`Page 2
`
`Page 4
`
` TABLE OF CONTENTS
`
`Witness: Cory J. Berkland, Ph.D.
`
`Examination
`By Mr. Chalson........................Page 6
`
`Reporter Certificate..................Page 316
`
`Notice to Read and Sign...............Page 318
`
`Index of Exhibits.....................Page 320
`
`JANE ROSE REPORTING
`1-800-825-3341
`
`National Court-Reporting Coverage
`janerose@janerosereporting.com
`
`Abraxis EX2070
`Apotex Inc. and Apotex Corp. v. Abraxis Bioscience, LLC
`IPR2018-00151; IPR2018-00152; IPR2018-00153
`
`

`

`US Patent and Trademark Office
`Actavis v. Abraxis
`
`FINAL - CONFIDENTIAL
`Cory Berkland, Nov. 30, 2017
`
`Page 5
` VIDEO SPECIALIST: Here begins video
`number 1, volume 1, in the deposition of Dr. Cory
`Berkland, Ph.D., taken in the matter of Actavis LLC
`v. Abraxis Bioscience LLC. Today's date is
`November 30th, 2017. The time on the video monitor
`is 8:19.
` This deposition is being taken at the office
`of Winston & Strawn and was made at the request of
`representatives of the Patent Owner. I am Jason
`Aqui, the videographer, and the court reporter is
`Linda Kinkade from Jane Rose Reporting, New York,
`New York.
` Counsel, please identify yourselves and
`state whom you represent.
` MR. CHALSON: Andrew Chalson from Quinn
`Emanuel on behalf of the Patent Owner. With me is
`Daniel Wiesner, also from Quinn Emanuel; Chris
`Harnett from Jones Day; and Patrick Elsevier from
`Celgene Corporation.
` MR. KLEIN: Chuck Klein with Winston &
`Strawn for Actavis and -- the Petitioner, and with
`me is Sharon Lin.
` MR. PATEL: Anil Patel with K&L Gates for
`Cipla Limited.
` VIDEO SPECIALIST: Will the court
`
`Page 6
`
`reporter please swear in the witness.
` CORY J. BERKLAND, Ph.D.,
` having been first duly sworn, was
`thereafter examined and testified as follows:
` EXAMINATION
`BY MR. CHALSON:
` Q. Good morning, Dr. Berkland.
` A. Good morning.
` Q. My name is Andrew Chalson. I'm here on
`behalf of the Patent Owner, and, as I'm sure you're
`aware, we're here to talk about patent products
`covering Abraxane. Do you understand that?
` A. Yes.
` Q. Can you state your full name and home
`address for the record?
` A. Cory J. Berkland, 1117 East 1264 Road,
`Lawrence, Kansas 66047.
` Q. You're currently employed by the
`University of Kansas?
` A. That's correct.
` Q. Were you hired to participate in the
`matters that we're here for today by Actavis?
` A. I was retained by counsel, but, yes, on
`behalf of Actavis.
` Q. You were also retained by Cipla and
`
`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
`
`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
`
`Page 7
`Apotex in two other proceedings involving the same
`patent; is that right?
` A. Yes, that's my understanding.
` Q. Are you represented by counsel today?
` A. Yes. I believe that's correct.
` MR. KLEIN: Well, it's --
` A. I don't know the legal --
` MR. KLEIN: We'll to the form.
`I'm not sure we technically represent him.
` Q. Do you know the answer to that,
`Dr. Berkland?
` A. It sounds like a legal argument. I don't
`know.
` Q. Okay. Do you know if you're represented
`by anyone else in the room today?
` A. I don't know.
` Q. You understand you're under oath?
` A. Yes, I do.
` Q. Is there any reason you can't testify
`truthfully and accurately?
` A. No, there is not.
` Q. You've been deposed before, correct,
`Dr. Berkland?
` A. Yes.
` Q. About how many times?
`
`Page 8
`
` A. I'd say around 15 probably.
` Q. It's fair to say you understand the
`process?
` A. Yes.
` Q. Have you been deposed recently?
` A. Yes, I think in the last six months.
` Q. When was the most recent deposition you
`did in a patent case?
` A. I think the most recent one, if I recall
`correctly, was an IPR proceeding on behalf of
`Alkermes.
` Q. Were you working with the Patent Owner or
`the challenger in that case?
` A. I was working with the Patent Owner.
` Q. Was there a drug product at issue in that
`case?
` A. Yes.
` Q. Do you recall which one?
` A. Risperdal Consta.
` Q. Do you know what dosage form that product
`is?
` A. It's an injectable.
` Q. Does it involve nanotechnology?
` A. No.
` Q. I think you said you've been deposed
`
`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
`
`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
`
`JANE ROSE REPORTING
`1-800-825-3341
`
`National Court-Reporting Coverage
`janerose@janerosereporting.com
`
`Abraxis EX2070
`Apotex Inc. and Apotex Corp. v. Abraxis Bioscience, LLC
`IPR2018-00151; IPR2018-00152; IPR2018-00153
`
`

`

`US Patent and Trademark Office
`Actavis v. Abraxis
`
`FINAL - CONFIDENTIAL
`Cory Berkland, Nov. 30, 2017
`
`Page 9
`
`Page 11
`
`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
`
`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
`
`about 50 times; is that right?
` MR. KLEIN: Fifty?
` A. Fifteen.
` Q. Fifteen. Of those 15, how many were
`patent cases?
` A. I think all but one.
` Q. Do you recall what the other one was
`about?
` A. Yeah. Thanks for jogging my memory. So
`I have been deposed recently in a dispute between
`the University of Kansas and a former graduate
`student.
` Q. Not a patent case.
` A. Not a patent case.
` Q. Other than the Risperdal case, have you
`been involved in any other IPRs?
` A. Perhaps. I can't remember.
` Q. Nothing comes to mind?
` A. Nothing comes to mind. Sometimes I don't
`even know or understand if it's an IPR. I mean,
`I'm asked for a legal -- I'm asked for an opinion
`on a technical matter, and sometimes the
`proceedings get twisted up in my mind whether it's
`an IPR or a patent dispute.
` Q. Were the other patent cases that you were
`
`Page 10
`involved in cases involving drug products?
` A. Not always.
` Q. About how many times have you been or
`have you provided written opinion in a case
`involving a patent dispute?
` A. Like a declaration or an expert report?
` Q. Any kind of written opinion.
` A. The number of cases would probably be a
`little fewer than 15 because there were times I was
`retained and didn't provide a written opinion, and
`there were times I was retained and provided
`multiple written opinions in a single case matter.
` Q. You're familiar with the Hatch-Waxman Act
`generally?
` A. Generally speaking.
` Q. Do you know what an Abbreviated New Drug
`Application is?
` A. Yes.
` Q. If I say an ANDA, you'll understand
`that's what I'm referring to?
` A. I will.
` Q. Have you ever testified at trial in an
`ANDA case?
` A. I've testified at trial several times,
`and I think -- I think two or three of them were
`
`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
`
`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
`
`ANDA cases, but I -- I'm not positive.
` Q. Do you expect to provide trial testimony
`in this case?
` A. If called upon, I guess.
` Q. You don't have an expectation one way or
`another sitting here today?
` A. My experience has been a lot of these
`matters settle, so I don't know.
` Q. You understand that we're here today in
`connection with proceedings before the Patent
`Office relating to the validity of patents relating
`to Abraxane?
` A. Yes.
` Q. You're also involved in pending
`litigation in federal court between the same
`parties regarding the same patents; is that right?
` A. I think that's correct, but ...
` Q. Do you know whether or not you signed a
`declaration and your name was disclosed in
`connection with the District Court litigation I
`just referred to?
` A. I'll take your representation that that's
`true.
` Q. You just don't have a specific
`recollection one way or the other today?
`
`Page 12
` A. I can't remember if that was signed early
`on and then the IPR representation was later. I
`can't recall.
` Q. What did you do to prepare for today's
`deposition?
` MR. KLEIN: We caution the witness not to
`reveal the contents of any communications with
`counsel.
` A. Sure. I arrived Tuesday, early in the
`morning, and spent the better half of Tuesday and
`yesterday preparing with counsel.
` Q. When you say "preparing with counsel,"
`are you referring to Mr. Klein and Ms. Lin?
` A. Yes.
` Q. Was anyone else present?
` A. I was joined by our third member here on
`the second day. We also had shared a video
`connection with counsel representing Apotex. I
`think that's correct.
` Q. Do you recall specifically who the
`attorneys were for Apotex?
` A. No, I can't recall their names.
` Q. Were there more than one person?
` A. Yes, two.
` Q. Man or woman?
`
`JANE ROSE REPORTING
`1-800-825-3341
`
`National Court-Reporting Coverage
`janerose@janerosereporting.com
`
`Abraxis EX2070
`Apotex Inc. and Apotex Corp. v. Abraxis Bioscience, LLC
`IPR2018-00151; IPR2018-00152; IPR2018-00153
`
`

`

`US Patent and Trademark Office
`Actavis v. Abraxis
`
`FINAL - CONFIDENTIAL
`Cory Berkland, Nov. 30, 2017
`
`Page 13
` A. A man and a woman. I'm sorry. I can't
`recall their names.
` Q. Did you talk to anyone else in
`preparation for your deposition?
` A. No.
` Q. Do you know if there's any kind of joint
`defense agreement or any other formal cooperation
`between Actavis and Apotex or Cipla?
` MR. KLEIN: Objection, foundation.
` A. I don't even know what that means from a
`legal perspective.
` Q. Fair enough. Who has engaged you in
`connection with any analysis you've done of the
`patents at issue in these proceedings?
` A. I was first engaged by Winston Strawn,
`and then over the week and a half leading up to
`this deposition was engaged by counsels
`representing Apotex and Cipla or no -- I get the
`legal terms mixed up with the company, the
`pharmaceutical companies sometimes. Hopefully
`that's correct.
` Q. Sure. So not going to hold you to any
`specifics --
` A. Okay.
` Q. -- as to who retained you, but in terms
`
`Page 14
`of the companies, correct me if this is wrong, but
`you were first retained by Actavis, right?
` A. Correct.
` Q. Through counsel?
` A. Yes.
` Q. And then you were subsequently retained
`by both Cipla and Apotex?
` A. That's correct.
` Q. So sitting here today, you are currently
`retained by all three of those companies in
`connection with analyzing the patents that we're
`here to talk about today.
` A. That's my understanding.
` Q. I think you said you were retained within
`the week or week and a half leading up to this
`deposition by Apotex and Cipla; is that right?
` A. Yeah. I can't recall when the latest
`declarations were filed on behalf of Apotex and
`Cipla, but it was roughly a week or so before those
`were filed.
` Q. Understood. Did you review any documents
`during preparation for your deposition?
` A. Yes.
` Q. Do you recall reviewing any specific
`documents?
`
`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
`
`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
`
`Page 15
`
` MR. KLEIN: You can -- I'll object on
`work product grounds, but you can answer the
`question generally.
` A. Yeah, I reviewed my declarations as well
`as responses. I reviewed the exhibits associated
`with those documents. I think that's about it.
` Q. Did you review anything that was
`exchanged by the parties or the Patent Office in
`this proceeding after you put your declaration in
`back in April?
` A. Are you -- are you asking if I reviewed
`any new material that wasn't part of the
`declaration as filed?
` Q. Yes.
` A. I can't recall.
` Q. So, for example, you understand that
`after you put your declaration in the Patent Owner
`put in a preliminary response in each of the four
`proceedings? Are you aware of that?
` A. Yes.
` Q. Did you review that preliminary response?
` A. I think they were provided to me, if I
`remember correctly, but I don't remember reading
`them in detail.
` Q. And subsequent to that, the Patent Office
`
`Page 16
`issued rulings in all four of the cases in which
`you put in declarations. Are you aware of that?
` A. Yes.
` Q. Have you reviewed those four rulings from
`the Patent Office?
` A. Again, I think they might have been
`provided to me. Actually I recall them being
`provided to me except for maybe the 260. I don't
`know if I saw that one or not since it wasn't
`instituted, but -- I had the documents. I don't
`know that I read them -- certainly didn't read them
`in detail.
` Q. And that's true even including your
`deposition prep over the last two days; you didn't
`review the preliminary responses or the Patent
`Office decisions in detail?
` A. That's true.
` Q. Let's just take a step back and talk
`generally about your education.
` You have a Bachelor of Science in chemical
`engineering from Iowa State in 1998; is that right?
` A. That's correct.
` Q. Did any of your coursework leading up to
`that degree focus on nanotechnology?
` A. I certainly was exposed to colloids in
`
`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
`
`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
`
`JANE ROSE REPORTING
`1-800-825-3341
`
`National Court-Reporting Coverage
`janerose@janerosereporting.com
`
`Abraxis EX2070
`Apotex Inc. and Apotex Corp. v. Abraxis Bioscience, LLC
`IPR2018-00151; IPR2018-00152; IPR2018-00153
`
`

`

`US Patent and Trademark Office
`Actavis v. Abraxis
`
`Page 17
`general, the transport of colloids, how colloids
`behave in chemical systems. I don't even know if
`at the time we called it nanotechnology or
`colloidal science or what we called it.
` Q. Sure. I guess that's what I'm getting
`at. Nanotechnology wasn't a developed area in
`1998, was it?
` A. No. I would say it was just called
`something different. Colloidal science has been
`around for a very long time.
` Q. In 1998 were you aware of any approved
`drug products that relied on nanotechnology?
` A. No, I wasn't aware of any.
` Q. You got a master's in chemical
`engineering from Illinois in 2001, right?
` A. That's correct.
` Q. Was any of your coursework in that, in
`your master's study, related to nanotechnology?
` A. I would give you the same answer, so --
`we studied colloidal materials and polymer science
`in the courses that I took as well as the transport
`of those.
` Q. As of the time that you got your
`master's, what experience, if any, did you have in
`formulating nanoparticle suspensions?
`
`Page 18
` A. I had worked on polymeric nanoparticles
`primarily, micro- and nanoparticles, and I had
`experience manufacturing polymeric or plastic
`nanoparticles, suspending them in different media,
`primarily focused on physical stability, so
`suspension stability, colloidal stability,
`settling, things like that, precipitation, not as
`much on chemical stability. I would say that's
`about where I was at as a master's.
` Q. So it's fair to say at that time you
`weren't focused on developing drug product
`formulations?
` A. No, I don't think that's a fair thing to
`say.
` Q. Okay. So help me understand the
`difference between the work you were doing in
`plastics and physical stability versus the lack of
`experience with chemical stability at that time.
` A. So most of my research was sponsored by
`the pharmaceutical industry, including Alkermes. I
`think, if I recall correctly, Alkermes was one of
`the first companies to sponsor the research that I
`was doing. And the plastics I was working on were
`biodegradeable plastics for use in pharmaceutical
`formulations. Specifically they related to 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
`
`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
`
`FINAL - CONFIDENTIAL
`Cory Berkland, Nov. 30, 2017
`
`Page 19
`
`types of polyesters that are used for the, you
`know, the stitches that dissolve when you stitch up
`inside a person. Those were being used to
`encapsulate pharmaceuticals to make them last
`longer, to modify their release.
` Q. Other than that experience, did you have
`any experience as of the time you got your master's
`in formulating nanoparticle suspensions?
` A. Yes.
` Q. What else?
` A. So I was also working with commercially
`available polymeric nanoparticles as controls or
`comparisons. Those didn't really have a
`pharmaceutical application, but I think the
`question was related to just polymeric nanoparticle
`formulations.
` Q. In terms of pharmaceuticals, I know you
`talked about dissolving stitches, other than that,
`did you have any experience at the time you got
`your master's in working with nanoparticle
`suspensions in the pharmaceutical context?
` A. I can't recall if this was during my
`master's degree, but I was also working with pure
`drug nanoparticles at some point during my master's
`and Ph.D. I just can't -- I can't discern if that
`
`Page 20
`happened when I was working on my master's or when
`I started my Ph.D. studies.
` Q. So you got a Ph.D. in 2003; is that
`right?
` A. That's correct.
` Q. Were you working on that also while you
`were getting your master's?
` A. Yes. At Illinois it's just one
`continuous process.
` Q. What is -- what is your Ph.D. in?
` A. Oh, one more clarification. So I was
`also working on polymeric gene delivery systems,
`which were colloidal formulations for
`pharmaceutical applications.
` Q. That was during your master's?
` A. Again, I can't recall if that was
`master's or Ph.D.
` Q. Sure. Did you have a thesis for your
`Ph.D.?
` A. I did.
` Q. What was that?
` A. I can't recall the exact title, but it
`was like micro- and nanoparticles for delivery of
`drugs or something to that nature for controlled
`release.
`
`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
`
`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
`
`JANE ROSE REPORTING
`1-800-825-3341
`
`National Court-Reporting Coverage
`janerose@janerosereporting.com
`
`Abraxis EX2070
`Apotex Inc. and Apotex Corp. v. Abraxis Bioscience, LLC
`IPR2018-00151; IPR2018-00152; IPR2018-00153
`
`

`

`US Patent and Trademark Office
`Actavis v. Abraxis
`
`FINAL - CONFIDENTIAL
`Cory Berkland, Nov. 30, 2017
`
`Page 21
`
`Page 23
`
`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
`
`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
`
` Q. Does any specifical pharmaceutical --
`excuse me.
` Does any specific pharmaceutical
`nanoparticle work jump out at you that you know you
`worked on during your Ph.D. studies that you hadn't
`done during your master's?
` A. I can't recall.
` Q. I think on your CV under your education
`you also talk about work done at Sofinnova
`Ventures. Does that sound right?
` A. Yes.
` Q. Can you describe that for me?
` A. So I took a sabbatical from the
`university and was retained as a consultant or
`analyst for Sofinnova Ventures. They are a biotech
`venture capital fund, and my job was to look at
`potential biotech company investments. And so, as
`part of that, I got to evaluate a lot of different
`company technologies and their clinical programs,
`their R&D activities, their regulatory path,
`et cetera.
` Q. Did you work on any drug development with
`Sofinnova Ventures?
` A. They don't do drug development, but I
`certainly evaluated the -- all these companies that
`
`Page 22
`
`were doing drug development.
` Q. Any of the companies that you evaluated
`working on developing nanoparticle formulations?
` A. Yes.
` Q. Can you talk about any of that here?
` A. No.
` Q. It's all confidential?
` A. Yeah, unfortunately.
` Q. In your professional career what work
`have you done relating to nanoparticle formulations
`in the pharmaceutical context?
` A. Just generally speaking, we worked on
`nanoparticles for delivery of genetic material,
`like DNA or RNA, silencing RNA. We've worked on,
`again, plastic nanoparticles or polymeric
`nanoparticles. We've worked on pure drug
`nanoparticulates as suspensions or as powders.
` Much of the work, much of that work has been
`on what I would call composites where nanoparticles
`were combined into larger structures to make
`aerosolized dry powders.
` But there may be more, but, categorically,
`that's what I'm thinking of off the top of my head.
` Q. You would agree with me that, in general,
`nanoparticles are complicated compared to
`
`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
`
`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
`
`traditional dosage forms?
` MR. KLEIN: Objection, form.
` A. It really depends on what we mean by
`"complicated" and what we mean by "traditional
`dosage forms."
` Q. So compared to tablets or capsules,
`nanoparticles are more complicated; do you agree
`with that?
` A. Well, there's approved drugs with
`nanoparticles in tablets and capsules, so I guess
`I'm trying to pick apart your question. A
`nanoparticle is part of a dosage form, so it's hard
`for me to compare it to a dosage form.
` Q. Sure. I think I had asked you if,
`compared to traditional tablets and capsules, so
`let's assume tablets and capsules without
`nanoparticles.
` A. Okay.
` Q. Nanotechnology, in general, nanoparticles
`in a pharmaceutical, in general, are more
`complicated than a traditional tablet or capsule
`formulation; do you agree with that?
` A. Well, it's going to have a time aspect
`associated with it, so at one point in time they
`were. So it's still a difficult question to
`
`Page 24
`
`answer.
` Q. Would you agree with me that in 2002-
`2003 time frame nanotechnology was new and
`unproven?
` MR. KLEIN: Objection, form.
` A. I think there was a similar question
`earlier. Again, that's a little bit of a
`subjective statement. So, you know, certainly
`advances had been made. I'm thinking of the
`Liversidge patent, you know, came out in 1992 and
`you're talking about ten years later.
` Clearly, nanoparticle formulations had been
`developed even earlier than the Liversidge patent.
`So it's a difficult question to answer directly.
` Q. Have you ever testified under oath that
`nanotechnology was new and unproven in 2002 or 2003
`time frame?
` A. Possibly, yeah, given the context of the
`question and answers.
` Q. Do you agree with the statement generally
`that in 2002-2003 nanotechnology was new and it was
`unproven?
` A. It would take --
` MR. KLEIN: Objection, form.
` A. It would take some foundation and some,
`
`JANE ROSE REPORTING
`1-800-825-3341
`
`National Court-Reporting Coverage
`janerose@janerosereporting.com
`
`Abraxis EX2070
`Apotex Inc. and Apotex Corp. v. Abraxis Bioscience, LLC
`IPR2018-00151; IPR2018-00152; IPR2018-00153
`
`

`

`US Patent and Trademark Office
`Actavis v. Abraxis
`
`FINAL - CONFIDENTIAL
`Cory Berkland, Nov. 30, 2017
`
`Page 25
`
`Page 27
`
`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
`
`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
`
`like, context in order to qualify that statement.
` Q. Do you agree that in 2002-2003
`nanotechnology was complex compared to traditional
`dosage forms like tablets or capsules?
` A. Again, it's sort of a subjective
`statement that would require some -- some context.
` Q. You don't agree, it's not your subjective
`belief sitting here today that in 2002-2003
`nanotechnology was complex?
` MR. KLEIN: Objection.
` A. I think I answered the question.
` Q. What is your answer?
` A. It would require some context, so complex
`in comparison to what? Complex --
` Q. Complex in comparison to tablets or
`capsules.
` A. So possibly. I'd have to see what you're
`talking about.
` Q. You're a cofounder of four companies,
`right?
` A. Yes, give or take. At least four that
`are out there in the public domain.
` Q. Are there others?
` A. Yeah, there's a couple of others we're
`working on. They're more like paper exercises
`
`Page 26
`
`than, you know, rolled-out companies.
` Q. Okay. Well, let's talk about the four
`that are in your CV, and then we can come back to
`the others.
` A. Okay.
` Q. Orbis Biosciences, that's one of the
`companies?
` A. Yes.
` Q. What is your role with Orbis Biosciences?
` A. I'm an acting chief scientific officer,
`also a cofounder and a board member, scientific
`advisory board.
` Q. You help Orbis Biosciences make decisions
`about what products to develop?
` A. Yeah, to some extent. I mean, ultimately
`that's a decision by management, but yes.
` Q. Management seeks your input in the roles
`you just described before making those decisions;
`is that correct?
` A. Typically.
` Q. Are you involved in helping steer Orbis
`Biosciences' decisions on how to formulate drug
`products that it wants to develop?
` A. Yeah, I would say typically.
` Q. You're also a cofounder of Savara
`
`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
`
`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
`
`Pharmaceuticals; is that right?
` A. That's correct.
` Q. What is your role with Savara
`Pharmaceuticals?
` A. I was a cofounder, and for a while I was
`heading the scientific advisory board, but I really
`had no formal association with the company for
`several years now.
` Q. How long were you on the scientific
`advisory board at Savara Pharmaceuticals?
` A. Several years, at least from the
`beginning. The difficult part of that question is
`I can't recall when a formal scientific advisory
`board was ever, like, brought together.
` Q. At any point in time were you involved in
`helping Savara Pharmaceuticals make decisions on
`what products to develop?
` A. Yes, to some extent.
` Q. And once products were in development,
`were you involved in helping Savara Pharmaceuticals
`decide how to formulate those products?
` A. Just at the very early stage, so
`preclinical formulation.
` Q. But at some level you provided advice to
`the company on ways in which they could formulate
`
`Page 28
`the products they wanted to develop; is that right?
` A. That's correct.
` Q. Orion Bioscience, that's another one that
`you cofounded; is that right?
` A. Yes.
` Q. What is your role with Orion Bioscience?
` A. I'm a cofounder and chairman of the
`board.
` Q. Still today?
` A. Yes.
` Q. When was that company founded?
` A. Oh, maybe about five years ago, give or
`take.
` Q. Do you help Orion Bioscience decide what
`drug products to develop?
` A. Yes, to some extent. It's input from
`multiple people, of course, but ...
` Q. Sure. You have -- you have some amount
`of scientific input on what products the company
`should develop; is that fair?
` A. That's fair.
` Q. And to the extent they've decided to
`develop products, you help Orion Bioscience decide
`how to formulate those products; is that right?
` A. Typically, yeah, I would be involved.
`
`JANE ROSE REPORTING
`1-800-825-3341
`
`National Court-Reporting Coverage
`janerose@janerosereporting.com
`
`Abraxis EX2070
`Apotex Inc. and Apotex Corp. v. Abraxis Bioscience, LLC
`IPR2018-00151; IPR2018-00152; IPR2018-00153
`
`

`

`US Patent and Trademark Office
`Actavis v. Abraxis
`
`Page 29
` Q. How about Bond Biosciences? What's your
`role there?
` A. So as a cofounder of Bond, I'm currently
`on the board, and I -- I don't know if I have an
`official title as, like, head of scientific
`advisory board or anything like that, but I
`generally manage the scientific side of the
`company.
` Q. And for Bond Biosciences, your role you
`just described would mean for that company as well
`you're helping them decide what products to
`develop?
` A. Yes.
` Q. And to the extent they decide to develop
`products, you're involved in helping them decide
`how to formulate those products?
` A. That's true. Again, I offer input,
`others offer input.
` Q. Sure. I'm not suggesting you're the sole
`decision-maker, but you provide your input on the
`direction they should go in how to formulate
`products, right?
` A. Yes.
` Q. You're also on the advisory board for the
`Journal of Pharmaceutical Science; is that right?
`
`Page 30
`
` A. Yes.
` Q. And that's true today?
` A. Yes, that's true. They have a couple of
`different levels. One is the editorial board and
`one is just an editorial advisory board, more of a
`technical advisory board, and that's the board I'm
`on. It's a very large number of people.
` Q. And you've had that role since 2008; is
`that right?
` A. That's probably right. I can't recall.
` Q. That's what it says in your CV.
` A. Okay. It should be right, then.
` Q. Can you describe for me what that role
`involves?
` A. You end up sort of being the point person
`on reviewing manuscripts. So my job would be to
`review manuscripts and maybe identify others with
`similar expertise who could review the same
`manuscript for publication.
` Q. You review manuscripts for the Journal of
`Pharmaceutical Science that relate to
`nanotechnology?
` A. Yes.
` Q. The Journal of Pharmaceutical Science is
`a reputable journal, 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
`
`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
`
`FINAL - CONFIDENTIAL
`Cory Berkland, Nov. 30, 2017
`
`Page 31
`
` A. It's pretty good.
` Q. It's been around for more than a hundred
`years?
` A. Yes. Well, I don't know actually.
` Q. I believe it was founded in 1912. Does
`that sound right?
` A. It could be. It sounds about right.
` Q. Everything that goes into the journal is
`peer-reviewed, right?
` A. Not everything. There's commentaries
`and --
` Q. Fair enough. Let me rephrase the
`question.
` All of the scholarly articles as opposed to
`editorials and notes and things like that would be
`peer-reviewed before they're published; is that
`fair?
` A. Research articles that would have data in
`them are typically peer-reviewed, yes.
` Q. The Journal of Pharmaceutical Science is
`a journal that your hypothetical person of skill in
`the art would be familiar with, right?
` A. They should be, yes.
` Q. I believe it says in your declaration
`that you're being paid $500 an hour for your work
`
`Page 32
`
`in this case; is that correct?
` A. That's correct.
` Q. Is your