Date: April 17, 2019
`
`Case: Certain Strontium-Rubidium Radioisotope Infusion Systems, and
`Components Thereof Including Generators
`
`THIS DOCUMENT CONTAINS CONFIDENTIAL
`INFORMATION
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`Phone: 202-347-3700
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`Internet: www.acefederal.com
`
`Bracco Ex. 2012
`Jubilant v. Bracco
`IPR2018-01449
`
`1
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`
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`Case: Certain Strontium-Rubidium Radioisotope Infusion Systems, and
`Components Thereof Including Generators
`
`THIS DOCUMENT CONTAINS CONFIDENTIAL
`INFORMATION
`
`Ace-Federal Reporters, Inc.
`Phone: 202-347-3700
`Fax: 202-737-3638
`Email: info@acefederal.com
`Internet: www.acefederal.com
`
`Bracco Ex. 2012
`Jubilant v. Bracco
`IPR2018-01449
`
`1
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`THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION
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` UNITED STATES OF AMERICA
` BEFORE THE
` INTERNATIONAL TRADE COMMISSION
`
`Page 939
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`- - - - - - - - - - - - - - - - - -X
`IN THE MATTER OF: : Investigation Number
`CERTAIN STRONTIUM-RUBIDIUM : 337-TA-1110
`RADIOISOTOPE INFUSION SYSTEMS AND :
`COMPONENTS THEREOF INCLUDING :
`GENERATORS :
`- - - - - - - - - - - - - - - - - -X
`
` HEARING
`
` April 17, 2019
` Courtroom C
` U.S. International Trade
` Commission
` 500 E Street, S.W.
` Washington, D.C.
`
`The Hearing commenced, pursuant to notice of the Judge, at
`9:02 a.m., before the Honorable CLARK S. CHENEY,
`Administrative Law Judge for the United States
`International Trade Commission.
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`Page 940
`APPEARANCES:
`1
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`On behalf of the Complainants:
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` MARK G. DAVIS, ESQ.
` PATRICK J. McCARTHY, ESQ.
` Goodwin Procter, LLP
` 901 New York Avenue, N.W.
` Washington, D.C. 20001
` (202) 346-4090
` markdavis@goodwinlaw.com
` pmmcarthy@goodwin.com
`
` -and-
`
` SCOTT J. BORNSTEIN, ESQ.
` BRIAN J. PREW, ESQ.
` JULIE BOOKBINDER, ESQ.
` Greenberg Traurig, LLP
` MetLife Building - 200 Park Avenue
` New York, New York 10166
` (212) 801-9200
` bornstein@gtlaw.com
` prewb@gtlaw.com
` bookbinderj@gtlaw.com --continued--
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`APPEARANCES (Continued):
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`Page 941
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` On behalf of the Respondents:
`
` T. CY WALKER, ESQ.
` JASON HOFFMAN, ESQ.
` Baker & Hostetler, LLP
` 1050 Connecticut Avenue, N.W.
` Washington, D.C. 20036-5304
` (202) 861-1688
` cwalker@bakerlaw.com
` jhoffman@bakerlaw.com
`
` JARED A. BRANDYBERRY, ESQ.
` Baker & Hostetler, LLP
` 1801 California Street
` Suite 4400
` Denver, Colorado 80202
` (303) 861-0600
`
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`Page 942
`APPEARANCES (Continued):
`1
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` On behalf of the Respondents (Continued):
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` KEVIN P. FLYNN, ESQ.
` Baker & Hostetler, LLP
` 312 Walnut Street
` Suite 3200
` Cincinnati, Ohio 45202
` (513) 929-3400
` Jubilant-Baker@bakerlaw.com
`
` KATRINA M. QUICKER, ESQ.
` Baker & Hostetler, LLP
` 1170 Peachtree Street, N.E.
` Suite 2400
` Atlanta, Georgia 30309
` (404) 459-0050
` Jubilant-Baker@bakerlaw.com
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`APPEARANCES (Continued):
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`Page 943
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` On behalf of the Respondents (Continued):
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` ANDREW E. SAMUELS, ESQ.
` Baker & Hostetler, LLP
` 200 Civic Center Drive
` Suite 1200
` Columbus, Ohio 43215
` (614) 462-2699
` asamuels@bakerlaw.com
`
` On behalf of the International Trade Commission:
`
` BRIAN KOO, ESQ.
` ANNE GOALWIN, ESQ.
` Office of Unfair Import Investigations
` U.S. International Trade Commission
` 500 E Street, S.W.
` Suite 401
` Washington, D.C. 20436
` (202) 205-2000
` Brian.Koo@usitc.gov
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`Page 944
`1
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`APPEARANCES (Continued):
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` ALSO PRESENT:
` For Complainant:
` Julie Bookbinder
` Myomi Coad
` Giancarlo Scaccia
` Allen Eaton
` Hector Perez
` Tessa Mager
` Guyan Liang
` Nito DiBari
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` For Respondents:
` Mitchell Guss
` Marc Lapointe
` Paul Donnelly
` Norman LaFrance
` Ricky Dyer
` Melissa Kuylen
` Diego Zuniga
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` P R O C E E D I N G S
` JUDGE CHENEY: Please take your seats. We're
`back on the record in the 1110 investigation. This is the
`fifth day of the evidentiary hearing. We have heard the
`Complainant's case in chief, the Respondents' case, and now
`we are in the midst of the rebuttal case by the
`Complainants.
` Before we resume the taking of evidence, do we
`have any housekeeping matters from the parties?
` Complainants?
` MS. COAD: Good morning, Your Honor. Myomi Coad
`for the Complainants.
` Your Honor, the parties would move for joint
`admission of the exhibits used yesterday during the April
`16th hearing.
` JUDGE CHENEY: Any objection from Respondents?
` MR. WALKER: No objection.
` JUDGE CHENEY: From the Staff?
` MR. KOO: No objections.
` MS. COAD: Your Honor, I would just like to
`clarify, the submission that we sent to the court reporter
`contains a document that was used on April 15th. That has
`now been marked as CX-787, as well as the depo designations
`and associated exhibits.
` JUDGE CHENEY: The exhibits provided to the
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`Page 946
`court reporter will be admitted without objection.
`1
` MS. COAD: Thank you, Your Honor.
` (Exhibits received here to be listed in index.)
` JUDGE CHENEY: Any other housekeeping matters?
`Okay. Our schedule this morning will be a little different
`than it's been the past two days. We'll take our first
`break at very close to 10:00. It will be for 30 minutes.
`And then we'll resume after that. We'll see how things go.
` Once we get to the end of the taking of
`evidence, we will take a short recess for you to meet and
`confer about the final exhibits that will be moved into
`evidence. Then I'll reconvene, we'll hear a motion to
`admit those things into evidence, then we'll close the
`record.
` It would be very helpful if you have client
`representatives that they plan to be here at the end of the
`hearing. I'll give some thoughts at that time.
` Anything else before we resume the taking of
`evidence? Okay.
` Complainants, please call your next witness.
` MS. BOOKBINDER: Good morning, Your Honor.
`Julie Bookbinder from Greenberg Traurig for the
`Complainants, and we call Dr. Norbert Pelc.
` JUDGE CHENEY: If you hold on for just one
`moment, we'll get the binders distributed, then we'll swear
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`Page 947
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`in the witness, and then you can begin.
` Are all the binders in the right places? Okay.
` Dr. Pelc, please stand, raise your right hand,
`and I'll administer the oath.
` (Oath administered.)
` JUDGE CHENEY: Thank you.
` And now, Ms. Bookbinder, you may continue.
` MS. BOOKBINDER: Thank you, Your Honor.
` NORBERT J. PELC, Sc.D.,
`having been first duly sworn, was examined and testified as
`follows:
` DIRECT EXAMINATION
`BY MS. BOOKBINDER:
` Q Good morning. Could you please introduce
`yourself?
` A I'm Norbert Pelc.
` Q Where do you currently work?
` A At Stanford University.
` Q Could we please see CX-696.
` Dr. Pelc, what is this exhibit?
` A Is it possible to get this screen to work? Oh,
`maybe it's just off.
` JUDGE CHENEY: Let's go off the record for a
`moment.
` (A discussion was held off the record.)
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` JUDGE CHENEY: We're back on the record after a
`1
`brief recess to deal with the witness well screen.
` Please continue, Ms. Bookbinder.
` MS. BOOKBINDER: Thank you, Your Honor.
` Q Dr. Pelc, what is Exhibit CX-696?
` A My CV.
` Q Does your CV accurately reflect your education
`and experience?
` A Yes.
` Q Did you have a series of demonstrative slides
`prepared under your supervision in order to assist the
`Court in this case?
` A I did.
` Q Could we please pull up CDX-2C at 2.
` Dr. Pelc, what is your current title?
` A I'm professor of bioengineering and radiology,
`and by courtesy of electrical engineering at Stanford
`University.
` Q Could you please describe your employment
`history at Stanford?
` A I was hired at Stanford in 1990 as associate
`professor of radiology, and promoted to full professor in
`1997. In 2002, I became associate chair for research for
`the radiology department. In 2004, we had started a new
`department in bioengineering, and I became professor of
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`Page 949
`bioengineering, keeping my appointment in radiology at that
`time.
` In 2012, I was asked to become chair of the
`bioengineering department. At that time I gave up my
`position as associate chair of radiology and became chair
`of bioengineering. I held that for the five-year term
`which ended in the summer of 2017.
` Q Let's talk about your educational background.
`Where did you go to school, beginning with college?
` A I was an undergraduate at the University of
`Wisconsin in Madison, where I majored in applied
`mathematics and engineering and physics, and at that time
`became interested in medical imaging and started taking
`courses in that field as an undergrad, and also worked in a
`research lab at Wisconsin.
` I then went to graduate school at Harvard, where
`I got a master's degree in 1976 and a doctorate of science
`in 1979, both in medical radiological physics.
` Q Could you please tell the Court a little bit
`more about the undergraduate courses you took relating to
`medical imaging?
` A Yes. They included a variety of courses in what
`we sometimes call medical physics. It included courses in
`imaging, including nuclear medicine, which actually that
`was my first exposure to imaging with positrons.
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` Q What did your doctoral research relate to?
`1
` A My doctoral research related to 3D imaging with
`both x-rays and radioisotopes. The dissertation itself at
`the time was more relevant to positron imaging than to
`anything else, and, in fact, I used positron imaging for
`the experiments in my dissertation.
` Q What did you do after graduating from Harvard?
` A I became a senior physicist at GE Medical
`Systems, where I worked in the development of
`instrumentation and application of medical imaging
`technologies. That included computer tomography, magnetic
`resonance, radionuclide imaging, ultrasound, x-ray imaging.
` Q What did you do next in your career after GE?
` A I left GE in 1990 to take the position that I
`mentioned earlier at Stanford.
` Q Has there been any particular focus of your work
`in medical imaging over your career?
` A The focus of my career really has been on the
`physics and mathematics and engineering of diagnostic
`imaging, of medical imaging, for now close to 50 years.
`Over the years, the particular area of focus has changed
`with my interests and curiosities, but it's always been
`related to technologies for medical imaging.
` Q Have you worked in positron imaging at Stanford?
` A Yes. So I mentioned my work with positron
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`Page 951
`imaging in graduate school. I continued to monitor what
`was going on with positron imaging for the following years,
`and a time came at Stanford when we wanted to develop a
`major program in molecular imaging. And PET, positron
`imaging, is really the best way to translate molecular
`imaging into studies in humans. So we needed to build up a
`program in positron imaging. And I was involved in
`recruiting more faculty, recruiting staff, getting
`access -- acquiring a cyclotron, positron imaging
`instrumentation, and other radiochemistry facilities for
`the PET program at Stanford.
` I've also continued to work on the technical
`aspects of this in research projects that include positron
`imaging.
` Q Have you worked with radioisotope elution
`systems before?
` A I have. The work that I mentioned in graduate
`school used a generator system. It was a germanium/gallium
`generator system because the half-life of gallium is more
`helpful for the kinds of studies that I was doing. And
`I've also worked with molybdenum/technetium generators that
`are the most commonly used generators in nuclear medicine.
` Q Have you received any awards for your
`contributions to medical imaging?
` A I was elected to the National Academy of
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`Engineering. I've been named fellow of the American
`1
`Association of Physicists in Medicine, the SPIE, which is
`an imaging society, the American Institute For Medical and
`Biological Engineering. I have an honorary medical degree
`from the Friedrich Alexander University in
`Erlangen-Nuremberg.
` Q Did you receive any awards at GE?
` A I received two awards that I'm proud of while --
`during the time I was at GE. One is called the Steinmetz
`award, which is for a long history of contributions to the
`company. And the second one was an award for being the
`first person at GE Medical Systems to get patents in all
`five major modalities.
` Q What are those five major modalities?
` A X-ray imaging, computer tomography, ultrasound,
`nuclear medicine, and magnetic resonance imaging.
` Q How many patents have you received?
` A I currently have 95 issued U.S. patents.
` Q What field are those in?
` A They're all in medical imaging.
` Q Have you published any articles or made any
`presentations relating to your work?
` A I have over 200 peer-reviewed publications and
`over 350 conference paper presentations.
` Q Thank you.
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`Page 953
` MS. BOOKBINDER: Your Honor, we proffer Dr. Pelc
`as an expert in the field of radiopharmaceutical elution
`systems and PET imaging.
` JUDGE CHENEY: Any objection?
` MR. HAILS: No objection, Your Honor.
` MR. KOO: No objections.
` JUDGE CHENEY: Dr. Pelc will be accepted as an
`expert in the fields tendered.
`BY MS. BOOKBINDER:
` Q Dr. Pelc, were you retained by Bracco as an
`expert in this case?
` A Yes.
` Q Can we move to slide 3, please.
` And Dr. Pelc, can you please tell the Court what
`you were asked to testify about?
` A I was asked to form opinions on assignor
`estoppel and on validity of the patents, validity including
`the items listed here: Anticipation, obviousness,
`prosecution laches, and improper inventorship.
` Q Did you conduct your analysis from the
`perspective of a person of ordinary skill in the art?
` A Yes.
` Q Were you present for the testimony of
`Respondents' expert, Dr. Stone?
` A I was.
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` Q Do you agree with Dr. Stone's opinions that the
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`asserted claims of the patents-in-suit are invalid?
` A I don't agree.
` Q Starting with Dr. Stone's opinions relating to
`prior art, at a high level, why do you disagree with him?
` A The prior art that Dr. Stone used, the primary
`reference was the Klein thesis. He also used the Tate
`patent application, and the earlier Bracco Model 510
`system. Those three references were in front of the
`examiner during the prosecution of the asserted patents and
`the parent to the asserted patents. And I agree with the
`examiner that the patents are valid in the face of those
`references.
` Q In addition to the references being considered
`by the examiner, are there any other overarching reasons
`that you disagree with Dr. Stone's analysis of the prior
`art?
` A I think that Dr. Stone is using hindsight and
`picking and choosing features from the literature to meet
`the claim elements. And I just don't agree with his
`statements regarding what would have been obvious to a
`person of skill in the art. I also disagree with his
`opinion on anticipation.
` Q Let's turn to anticipation at slide 26.
` Why do you agree with Dr. Stone on anticipation?
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` A I disagree with Dr. Stone on anticipation.
` Q Yes. Why do you disagree?
` A Next slide, if we could go to the next slide.
` Q Slide 27 of CDX-2C?
` A So it's not Allen -- which -- yes. So the
`argument that Dr. Stone made is that the asserted patents
`are anticipated by the 2016 RUBY manual. But the priority
`date of the asserted patents is no later than June 2009.
`And the RUBY manual became available in 2016. So it's
`simply later than the priority date.
` Q Is the RUBY manual prior art to the asserted
`patents?
` A No.
` Q Did Dr. Stone rely on any other references for
`his anticipation analysis?
` A No.
` Q Were you present for Dr. Stone's testimony that
`the inventors did not possess the inventions of the
`asserted claims until 2017?
` A I heard that, yes.
` Q Do you agree with that?
` A No.
` Q Why not?
` A Because the parent to the asserted patents has a
`clear description of the claims and supports the asserted
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`Page 956
`claims. I think I heard Dr. Stone say that the asserted
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`claims are enabled by the specification of the PCT
`application, which was filed in 2009.
` Q Were you also present when Dr. Stone
`characterized the asserted claims generally as automating
`past procedures?
` A Yes.
` Q Do you agree with Dr. Stone's opinion?
` A No.
` Q Why not?
` And we can go to slide CDX-2C at 19, please.
` A Thank you. This slide shows claim 1 from the
`'869 patent and claim 1 from the '826 patent. And the
`point that I want to make with it is noting all the
`structural features that are named in these claim elements.
`We have an exterior shell. We have a platform. We have a
`computer configured to do certain things. We have
`shielding compartments. We have shielded wells. There are
`a whole sort -- host -- excuse me, a whole host of
`structural features that are named in the asserted claims.
` Q You were just giving some examples from the '869
`patent. Do the other asserted patents have similar
`examples?
` A Yes. Yes, they all do.
` Q And can we go to CDX-2C at 20.
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`Page 957
` A So this is -- excuse me. This is claim 1 of the
`'870 patent. And again, this is a -- although it's a
`method, it talks about waste bottles and computers and
`eluate reservoirs in the shielded well on board the cart
`and so on.
` Q Has this combination of structural elements and
`computerization in the asserted claims been described in
`any of the prior art references relied on by Dr. Stone?
` A No.
` Q Based on your understanding of the facts of this
`case, who came up with the methods for the rubidium elution
`system with these features?
` A The inventors of the asserted claims.
` Q Let's move forward to CDX-2C.28.
` Do you agree with Dr. Stone that the asserted
`claims are obvious in view of the references that he cited?
` A No.
` Q Please go to CDX-2C -- excuse me.
` Did you review the prosecution history of the
`asserted patents?
` A Yes, I did. I reviewed the prosecution history
`of the asserted patents and also of the parent PCT
`application.
` Q So one of the binders there should be JX-4, 5,
`and 6. Could we bring those up quickly together.
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`Page 958
` Do we have a visual of JX-4, 5, and 6? Thank
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`you.
` And what are those?
` A These are the illegible front pages of the
`prosecution file histories for the three asserted patents.
` Q Are they more legible in the binder?
` A Yes. They're perfectly legible in the binder.
` Q You also mentioned the parent patent. There
`should be a big binder of CX-169.
` A Yes.
` Q Is that the prosecution history that you were
`referring to?
` A Yes.
` Q Let's go to CDX-2C at 31, please. What did you
`learn from reviewing the file history of the parent patent
`application?
` A Yes. So the parent patent application was
`filed, and the examiner rejected all the claims, and among
`the arguments that the examiner used to reject all the
`claims was anticipation by the Tate reference. This is the
`same Tate reference that Dr. Stone uses. And as we've
`heard, the Tate system is an infusion cart that is
`especially designed for delivering FDG, but it doesn't have
`a generator, it doesn't have elution, it doesn't have many
`of the things that are taught in the PCT and in the
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`Page 959
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`asserted patents.
` And the applicants explained this to the
`examiner, and you see the highlighted text here, that they
`explained to the examiner that this is because the system
`of Tate does not generate radiopharmaceuticals but rather
`stores and delivers a pharmaceutical manufactured elsewhere
`during a patient procedure.
` The examiner considered the claim. You see that
`in the lower box, that the argument was fully considered
`and found to be persuasive, and the examiner withdrew the
`rejection of Tate.
` I'm sorry, this was Tate in view of Quirico,
`which was not an anticipation, it was an obviousness
`rejection.
` Q You were referring on slide 31 to CX-169.2223
`and 169.2243?
` A Yes. Those are pages in the prosecution file
`history. Thank you.
` Q Did the Tate reference come up again during
`prosecution of the parent patent application?
` A Yes. Later in the prosecution of the patent,
`the examiner again rejected claims and again used the Tate
`reference. And in this case, again, the applicants argued
`back to the examiner and said, indeed, Tate does not and
`cannot disclose a computer preprogrammed to execute a
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`Page 960
`method according to independent claim one because Tate does
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`not relate to a system that generates and infuses
`radiopharmaceuticals via elution within a generator
`whatsoever. And you see an amplification of that. Again,
`the examiner considered that argument and found it
`persuasive and withdrew the rejection.
` Q So that was slide 32, and you're relying on
`CX-169.2498 and 2686?
` A Yes, that's correct. Thank you.
` Q Do you agree with the examiner?
` A I do.
` Q You've made some references to infusion and
`elution. Are those different kinds of systems?
` A Very much so. And I think it's important to
`keep those differences in mind.
` An infusion system like Tate, someone
`manufactures the radiopharmaceutical elsewhere. For
`example, for FDG, in a cyclotron, the radiopharmaceutical
`is brought on board the cart, and then the function of the
`Tate reference is to go to where the patient and the camera
`are, and administer the radiopharmaceutical, which includes
`what I will call metering the amount of radioactivity. But
`that I mean measuring and delimiting the amount of
`radioactivity, knowing that it's the right amount, and then
`infusing that to the patient.
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`Page 961
` An elution, an infusion system has to do that,
`but in addition has to generate the radiopharmaceutical.
`So it has to have a generator on board. It has to do the
`quality control necessary to make sure that the
`radiopharmaceutical that was manufactured is safe, and then
`it goes ahead and infuses it.
` So I think there's a big difference between the
`two, and the examiner of the parent PCT agreed.
` Q Is one of those types of systems described in
`the Klein thesis that Dr. Stone relied on?
` A The Klein thesis is a generator system. It's an
`elution and infusion system.
` Q I think you just said that Tate is an infusion
`system?
` A That's correct.
` Q Which type of system is described in the
`asserted patents?
` A It's an elution and infusion system, a
`generator-based system.
` Q Let's look at one of the asserted patents, JX-1
`at 32, please, in particular if we could go to column 1 at
`line 26. And what are we seeing here?
` A Thank you. So this is the beginning of the '826
`patent, and the applicants describe the technical field by
`saying that the present invention pertains to systems that
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`generate and infuse radiopharmaceuticals. So I think
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`that's quite clear.
` Q Is Tate in this field of endeavor?
` A No.
` Q Dr. Stone also mentioned a Medrad reference. Is
`Medrad in the field of this endeavor?
` A No. The Medrad Intego system and the Tate
`reference are similar. They're both FDG infusion only
`systems.
` Q Let's return to the slides, please, at CDX-2.35.
`And we've redacted certain aspects here due to the Bayer
`confidential. At a high level, though, did Dr. Stone
`present any evidence that the Medrad manual is prior art to
`the asserted patents?
` A I'm sorry. There was a whole discussion about
`Medrad and the legal aspects of whether that's a prior art
`or not. I will leave that to the lawyers to decide.
` Q Do you recall any testimony about the Medrad
`system?
` A Yes. And certainly Dr. Stone presented evidence
`that the Medrad system was displayed at a Society of
`Nuclear Medicine meeting, and that it was offered for sale.
`I think he showed an invoice or a bill of sale. And then
`there was a discussion about a user manual with no
`certainty that the user manual actually characterized the
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`Page 963
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`system that was demonstrated or offered for sale.
` Q Let's talk about slide 35. What's being
`presented here?
` A Yes. So what I tried to do in this slide is to
`show the difference from in terms of physical requirements
`and physical properties of an FDG infusion system like the
`Tate reference, that's the right-hand column, and a
`rubidium infusion system like the Klein thesis or the
`Bracco 510, that's the middle column.
` Q Can you please give a summary of the differences
`and how to handle the radiopharmaceuticals as in the middle
`column for the Klein thesis as compared to the right-hand
`column for Tate?
` A Yeah. And the reason I did this is that I think
`these differences are really important to the person who's
`designing these systems and will guide the requirements for
`the systems.
` So beginning with the radioisotopes, FDG is
`labeled with fluorine-18, which is a positron emitter with
`a half-life of about two hours. By contrast, rubidium-82,
`which is made by the elution system, is also a positron
`emitter, which may make you think that they're the same,
`but the half-life of rubidium is only a little bit over a
`minute. So once you make the rubidium, you better use it
`really fast because it's disappearing before your eyes.
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` By contrast, the FDG has a half-life of two
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`hours, so life is way more leisurely in terms of handling
`the FDG.
` The way they're manufactured is quite different.
`I mentioned earlier, the fluorine-18 for FDG is made in a
`cyclotron. This is a particle accelerator. The fluorine
`that comes out of the cyclotron then has to be chemically
`manipulated to be made into FDG, and this is done in
`automated hot cells, which also do quality control to make
`sure that's what's actually in the vial is pure fluorine-18
`FDG that's safe to give to patients. So the quality
`control has been done by the time it's given to the Tate
`cart.
` Instead, the rubidium system has to manufacture
`the rubidium right on board the cart b
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