Transcript of Joel M. Cohen
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`Date: May 19, 2022
`Case: Regeneron -v- Novartis (PTAB)
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`Planet Depos
`Phone: 888.433.3767
`Email: transcripts@planetdepos.com
`www.planetdepos.com
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`WORLDWIDE COURT REPORTING & LITIGATION TECHNOLOGY
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`Novartis Exhibit 2340.001
`Regeneron v. Novartis, IPR2021-00816
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`

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`Transcript of Joel M. Cohen
`Conducted on May 19, 2022
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`A P P E A R A N C E S (cont'd):
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`ON BEHALF OF PATENT OWNERS:
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` DANIEL MARGOLIS, ESQUIRE
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` ALLEN & OVERY LLP
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` 1221 Avenue of the Americas
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` New York, NY 10020
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` 212.610.6375
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` daniel.margolis@allenovery.com
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` L S O P R E S E N T:
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` UNITED STATES PATENT AND TRADEMARK OFFICE
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` BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`REGENERON PHARMACEUTICALS, INC., :
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` Petitioner : Case No.
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` vs : IPR2021-00816
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`NOVARTIS PHARMA AG, NOVARTIS :
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`TECHNOLOGY LLC, NOVARTIS : Patent No.
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`PHARMACEUTICALS CORPORATION, : 9,220,631
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` Patent Owners :
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` HAROLD RODRIGUEZ, A/V Technician
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` JAMES EVAN, ESQUIRE, Regeneron
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` Oral deposition of
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` ANDREW GEISOR, ESQUIRE, Regeneron
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` JOEL M. COHEN
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` VIA VIDEO/TELECONFERENCE
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` THURSDAY, MAY 19, 2022
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` 10:06 a.m. EASTERN TIME
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`Job No.: 448286
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`Pages: 1 - 128
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`Reported by: Lisa V. Feissner, RDR, CRR, CLR
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` C O N T E N T S
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`EXAMINATION OF JOEL M. COHEN PAGE
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` By Mr. Margolis 5
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` E X H I B I T S
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`A P P E A R A N C E S:
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`ON BEHALF OF PETITIONER:
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` CHRISTOPHER M. PEPE, ESQUIRE
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` NATALIE C. KENNEDY, ESQUIRE (NY office)
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` MATTHEW D. SIEGER, ESQUIRE
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` ISHA AGARWAL, ESQUIRE
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` WEIL, GOTSHAL & MANGES LLP
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` 2001 M Street, NW
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` Washington, D.C. 20036
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`PLANET DEPOS
`888.433.3767 | WWW.PLANETDEPOS.COM
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`Novartis Exhibit 2340.002
`Regeneron v. Novartis, IPR2021-00816
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`

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`Transcript of Joel M. Cohen
`Conducted on May 19, 2022
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`prefilled syringes?
` A No, none of the cases involved prefilled
`syringes.
` Q Okay. Did any of those cases involve
`Parylene C?
` A No, none of the cases I supported
`Gradient expert witnesses involved Parylene C.
` Q Did any of those cases involve silicone
`oil?
` A No, none of the cases involved silicone
`oil.
` Q Did any of those cases involve syringes
`of any kind?
` A No. While my supporting of expert
`witness work at Gradient did not involve Parylene C,
`prefilled syringes, silicone oil, in other contexts,
`my professional activities have involved prefilled
`syringes, toxicological risk assessment of prefilled
`syringes, and the materials and various components
`of those syringes.
` So while in the expert testimony support
`work, it has -- they have not addressed those items,
`8
`but in other contexts, as a principal at Gradient, I
`have conducted toxicological risk assessments on
`those, on prefilled syringes.
` Q Okay. But you've never acted as an
`expert witness or in support of an expert witness in
`a case involving syringes or prefilled syringes or
`Parylene C or silicone oil; is that correct?
` A That is correct. I've never been
`involved as an expert witness or supported an expert
`witness on those matters. However, in other
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`contexts, I have conducted toxicological risk
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`assessments on prefilled syringes.
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` Q And you mentioned that you worked on one
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`other litigation prior to this one as an expert
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`witness yourself?
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` A That is correct.
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` Q Okay. And did that case involve either
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`syringes or Parylene C or silicone oil?
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` A No. That case did not involve syringes
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`or silicone oil.
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` Q Okay. Was that a patent litigation?
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` A It was not a patent litigation. There
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` P R O C E E D I N G S
` JOEL M. COHEN,
`having been first duly sworn, was examined and
`testified as follows:
` EXAMINATION
`BY MR. MARGOLIS:
` Q Good morning. How are you?
` A I'm good this morning.
` Q Is it Dr. Cohen?
` A Either is fine, Dr., Mr., no preference.
` Q Okay. And would you just mind please
`stating your name for the record.
` A Joel Cohen.
` Q And Dr. Cohen, have you ever been deposed
`before?
` A I've never been deposed, but I've been
`retained as an expert witness and submitted expert
`reports.
` Q Okay. In approximately how many cases?
` A Including this case today?
` Q Yes.
` A That would be two cases.
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`6
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` Q Okay. So one other case, you've
`submitted an expert report in?
` A That's correct, as the expert. In
`addition, I've supported a number of other experts
`in their expert testimony and expert reports.
` Q Okay. So what do you mean by that?
` A At the direction of the expert witness,
`have done research and evaluated materials to
`contribute to that expert's understanding of the
`case.
` Q Got it, okay.
` And how many times have you been involved
`in a litigation in that capacity?
` A A number of times. Over the past eight
`years at my career at Gradient, on the order of 20
`to 30 different projects.
` Q Okay. And was that always working under
`other Gradient employees?
` A Yes. I was supporting Gradient expert
`witnesses.
` Q Got it, okay.
` And did any of those cases involve
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`Novartis Exhibit 2340.003
`Regeneron v. Novartis, IPR2021-00816
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`

`

`Transcript of Joel M. Cohen
`Conducted on May 19, 2022
`9
`was a complaint that a consumer product had caused a
`skin irritation hazard, and I was evaluating the
`likelihood that the consumer product could have
`posed that risk to the consumer.
` Q And what was the product?
` A I'm not at liberty to say.
` Q Okay. Can you tell me who you were
`representing?
` A I was not -- I was representing the
`defendant in that instance.
` Q Okay.
` A So that would have been --
` Q Go ahead.
` A Oh, so the retailer that was selling the
`consumer product to the consumer. That was who I
`was representing.
` Q Okay. And can you tell me who that
`retailer was?
` A No, I'm not at liberty to say.
` Q Okay. Was it any of the parties involved
`in this case? And by that I mean either Regeneron
`or Novartis.
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`and don't have a lot of understanding of -- or
`really any understanding of what that project
`involved.
` Q Okay. Did it involve syringes?
` A Not that I'm aware.
` Q I think I asked this, but I'll ask it
`again just to make sure.
` Have you ever worked with Novartis
`before?
` A No, I've never worked with Novartis.
` Q Okay. And to your knowledge, has
`Gradient ever worked with Novartis before?
` A To my knowledge, I don't believe so, no.
` Q And so you submitted a declaration in
`this case, and is that Exhibit 1108? And if you
`like, I can pull that up for you.
` A Yes, that's -- Exhibit 1108 is my
`declaration.
` Q And when were you first contacted to work
`on this case?
` A I was first contacted about this case
`maybe winter 2022.
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` A No. It was none of the parties involved
` Q Winter of 2022. So earlier this year?
`in this case today.
` A That's correct.
` Q Okay. Was it a pharmaceutical company?
` Q Like January, around?
` A No, it was not a pharmaceutical company.
` A Around then, yes.
` Q Okay. And is that case still ongoing?
` Q Okay. And who contacted you?
` A No. That case resolved.
` A Chris Pepe.
` Q Okay. So this is -- sorry.
` Q And were you provided any materials?
` Did you end up testifying in any capacity
` A At that time --
`in that case, either at trial or by deposition?
` MR. PEPE: I'll just object and caution
` A No, I was not deposed in that case. It
`you not to divulge the substance of any of our
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`was -- the expert report was enough to resolve the
`communications.
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`matter.
` But you can answer that question yes or
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` Q Okay. And in this case, you've submitted
`no.
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`a declaration on behalf of Regeneron, correct?
` A At that time, I was more asked about my
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` A Yes, that is correct.
`experience in expert testimony and extractables and
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` Q And prior to this case, had you ever done
`leachables, things of that nature, as more about my
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`any work with Regeneron?
`qualifications.
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` A No, I've not worked with Regeneron prior
` Q Okay. And at what point in time -- well,
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`to this case.
`at some point in time, you were asked to provide a
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` Q Okay. Had Gradient worked with Regeneron
`declaration by Regeneron, right?
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`prior to this case?
` A Yes, that's correct.
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` A Yes, I believe so, but I was not involved
` Q Okay. And when was that?
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`Novartis Exhibit 2340.004
`Regeneron v. Novartis, IPR2021-00816
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`

`

`Transcript of Joel M. Cohen
`Conducted on May 19, 2022
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` A Late winter 2022. So February, March,
`around that time.
` Q Okay. And what did you understand the
`subject matter of your declaration would be?
` MR. PEPE: I'm going to object and just
`caution you not to divulge the substance of any
`communications we had. But to the extent you can
`answer the question without doing that, you can
`answer.
` A As indicated in paragraph 2 of my
`declaration that defines the scope of my analysis
`and opinions, that's been my understanding of my
`role in this case.
` Q Okay. And what did you do in order to
`prepare your declaration? Well, let me take that in
`pieces. I'll strike that question.
` Did you review materials in order to
`prepare your declaration?
` A The materials I reviewed for preparing my
`declaration are all cited within the declaration,
`included as exhibits.
` Q You didn't review anything other than the
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`case, had you -- were you familiar with any of the
`documents that you rely on in your declaration?
` A So Exhibits 2042 and 2181 are the ISO
`10993-1 standard. That, I'm familiar with and have
`been familiar with this prior to this project.
` Q Were you familiar with any of the other
`exhibits cited in your declaration prior to your
`involvement in this case?
` A No, I was not familiar with the other
`exhibits provided or cited in my declaration.
` Q Okay. So you weren't familiar, prior to
`your involvement with this case, with the Chang
`article that's Exhibit 2030?
` A No, I had not seen that article prior to
`this case.
` Q Okay. And you had not seen the Kaminska
`article, Exhibit 2031, prior to this case?
` A Correct, I had not seen that article
`either.
` (Reporter interruption.)
` Q Dr. Cohen, prior to your involvement in
`this case, you had not seen either of these SCS
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`exhibits cited in your declaration in order to
`documents, Exhibits 1074, 1075, about Parylene C; is
`prepare your declaration?
`that correct?
` A That is correct. I didn't review
` A That's correct.
`anything that was not cited in my declaration in
` Q You currently work at Gradient; is that
`preparing the declaration.
`right?
` Q Okay. Did you talk to anyone other than
` A Yes, I currently work at Gradient.
`counsel in preparing your declaration?
` Q And could you just describe what Gradient
` A No.
`is, what field they operate in.
` Q You didn't have anybody helping you out
` A So Gradient is a scientific consulting
`like you would have helped out somebody else in one
`firm with a number of practice areas. My practice
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`of those cases you were mentioning before?
`area is what's described as the product stewardship
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` A No. No one helped me write the
`area supporting toxicological risk assessment,
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`declaration.
`consulting services for a variety of products.
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` Q Okay. And you didn't do any independent
` And my practice area focuses on medical
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`searching for additional documents beyond the
`device toxicological risk assessment and
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`exhibits cited in your declaration; is that correct?
`pharmaceutical toxicological risk assessment, among
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` A That's correct, I did not.
`others things. But that's one of the practice areas
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` Q And the documents that you do cite in
`that the consulting firm at large focuses on.
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`your declaration, they were all provided to you by
` Q Okay. Is one of the areas Gradient is
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`counsel; is that right?
`involved in providing expert witness support in
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` A Yes, that is correct.
`litigations?
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` Q Okay. Prior to your involvement in this
` A Gradient principals do offer expert
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`Novartis Exhibit 2340.005
`Regeneron v. Novartis, IPR2021-00816
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`

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`Transcript of Joel M. Cohen
`Conducted on May 19, 2022
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`assessment. So my graduate training and then my
`entire professional career at Gradient applied
`toxicological risk assessments for a variety of
`contexts.
` Q Okay. So what was it, then, that goes
`back five or six years? That was something
`different than what you started doing at that point
`in time? I might have misunderstood your answer.
` A For the past five or six years, the
`majority of my time is spent on medical devices
`and/or pharmaceutical toxicological risk
`assessments, whereas prior to that, I was
`risk-assessing consumer products.
` My graduate research, I was looking at
`other engineered nanomaterials in a variety of other
`types of consumer products.
` So the principles of toxicology and risk
`assessment, I was applying, but not within the
`regulatory framework of, for example, the 10993
`series or other sorts of products. So that was what
`the timeline referred to.
` Q Okay. Thank you.
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`witness support in litigation. I've personally
`provided expert reports in litigation matters. So
`yes.
` Q Okay. And approximately what percentage
`of Gradient's work is expert-witness-type work as
`opposed to general consulting?
` A I can't speak for the company at large.
`I can speak for my personal practice where it
`comprises maybe 5 percent, 10 percent at most of my
`total business.
` Q Okay. But you don't know, for Gradient
`generally, what those percentages would be?
` A No, no, I don't.
` Q Okay. And what is your position at
`Gradient?
` A I'm a principal, part owner of the
`company.
` Q And I think you touched on this in one of
`your previous answers, but generally speaking, what
`are your responsibilities?
` A So my key practice areas involve
`toxicological risk assessment of various products,
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`consumer products as well as medical devices and
` Just so I'm clear, then, prior to 2016,
`pharmaceutical products.
`you had not been involved in toxicological risk
` My toxicological risk assessment reports
`assessments of medical devices; is that right?
` A That's fair to say.
`are included in either the development of these
`products for internal understanding or for
` Q Okay. And of the medical devices you've
`submission to regulators, be it the FDA, notified
`worked on in the course of your career, how many
`bodies in the EU, or other jurisdictions, for review
`different types of medical devices have you been
`and hopefully for acceptance and release to market
`involved with?
`so these products can be used in hospitals and
` MR. PEPE: Object to form.
` A I've supported the development, via my
`clinics.
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`toxicological risk assessments, of a wide variety of
` Q And for how long have you been involved
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`devices, including dialysis equipment, orthopedic
`in these toxicological assessments of medical
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`implants, cardiac implants, surgical instruments,
`devices?
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`ventilator-type devices with breathing gas pathway
` A Five to six years.
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`exposure or treatment sort of operations. So a wide
` Q Okay. So going back to about 2016? Is
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`and varied array.
`that about right?
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` A That's correct.
` Q Got it.
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` And have you supported the toxicological
` Q Okay. So prior to 2016, had you
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`risk assessment of syringes at any point in time?
`conducted any toxicological risk assessments?
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` A Yes, actually, toxicological risk
` A Yes. The nature of my work at Gradient
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`assessment for a prefilled syringe product very
`prior to that, as well as my doctoral research,
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`recently conducted. I was also hired to do another
`involved toxicological hazard assessment and risk
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`Novartis Exhibit 2340.006
`Regeneron v. Novartis, IPR2021-00816
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`

`

`Transcript of Joel M. Cohen
`Conducted on May 19, 2022
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`one, another risk assessment on a prefilled syringe
`product just this past month. So yes.
` Q Okay. So how many, throughout the course
`of your career, risk assessments have you conducted
`on syringes of any kind?
` A So that would be the one -- the two risk
`assessments on syringes, the one that's already
`completed and the one that is ongoing.
` But to more broadly answer your question,
`high-risk devices with direct tissue contact for --
`with the potential for permanent sort of exposures
`duration, these are what are considered the highest
`risk medical devices, I've completed risk
`assessments on upwards of a hundred different
`devices of that nature, which apply similar risk
`assessment principles in light of the high-risk
`scenario and high risks that could be posed to
`patients.
` Q Okay. So you'd agree that a prefilled
`syringe for intravitreal injection of a VEGF
`antagonist would qualify as a high-risk medical
`device, right?
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` Q And would you understand that prefilled
`syringe for intravitreal injection of a VEGF
`antagonist to be a high-risk medical device?
` MR. PEPE: Object to form.
` A Again, it would depend on the treatment
`duration. That would also impact the risk
`classification, whether it was a one-time injection
`or injections that occurred over the course of many
`years, over ten years, for example. That would
`impact the risk classification.
` But the nature of the syringe being
`intravitreal injection would put it in a higher risk
`category than perhaps a Band-Aid or something else
`of that nature.
` Q Do you have an understanding of for how
`long or over what time period the prefilled syringes
`involved in this case would be administered?
` MR. PEPE: Object to form.
` A That was not a focus of my review. My
`opinions are, as stated in paragraph 2 of my
`declaration, focused on responding to claims made in
`Dr. Dillberger's declaration. And the treatment
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` MR. PEPE: Object to form.
` A The other thing to consider would be the
`treatment duration, how many treatments would be
`required, would it be a routine treatment over the
`course of a decade, or is it a one-time treatment.
`So the nature of the treatment would also impact the
`risk classification.
` Q Okay. So the prefilled syringes involved
`in this case, do you have an understanding of what
`they are?
` MR. PEPE: Object to form.
` A Could you please clarify the question?
` Q Sure. You've read the patent at issue in
`this case, right?
` A Yes, that's correct.
` Q And you've reviewed the claims of the
`patent, correct?
` A Yes, that's correct.
` Q And you understand that those claims are
`directed, generally speaking, to a prefilled syringe
`for intravitreal injection of a VEGF antagonist?
` A Yes, that's correct.
`
`24
`regimen was not ever raised as an issue of concern,
`so my review did not focus on those matters.
` Q Okay. So you didn't undertake to
`determine whether or not the prefilled syringes
`containing VEGF antagonists for intravitreal
`injection involved in this case would have been
`understood to be in a high-risk category or not; is
`that correct?
` MR. PEPE: Objection to form.
` A For my declaration and the opinions
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` Q Okay. So you mentioned that you've
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` A That is correct.
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` Q And when was the first time that you
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` A Summer of 2022 -- sorry -- 2021, summer
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`Novartis Exhibit 2340.007
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`Transcript of Joel M. Cohen
`Conducted on May 19, 2022
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` MR. PEPE: Object to form.
` Q I'll strike that.
` Did either of those prefilled syringes
`include Parylene C as a component?
` A No, neither syringe included Parylene C,
`to my knowledge. However, there were various
`coatings on the rubber stoppers of the syringe that
`did impact the toxicological risk assessment.
` Q What types of coatings?
` A Again, I'm not at liberty to say due to
`those confidentiality agreements.
` Q Were they coatings that had been used in
`prior prefilled syringes?
` MR. PEPE: Object to form.
` A They were common coatings that are
`commonly used in prefilled syringes.
` Q Okay.
` A And outside the context of those risk
`assessments, I have risk-assessed novel materials
`for use in high-risk medical device classifications.
` So for -- yeah, so to the question as to
`whether I've risk-assessed novel materials without a
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`long clinical history of safe use, I have submitted
`toxicological risk assessments in those cases for
`other medical devices other than prefilled syringes.
` Q But the prefilled syringes you've worked
`on did not contain any novel components; is that
`right?
` MR. PEPE: Object to form.
` A Can you define "novel components"?
` Q By "novel components," I mean components
`that had not been used in an analogous way in a
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`prior device.
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` A I'm not sure I'm at liberty to say that.
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` Q Okay. But neither of the prefilled
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`syringes you worked on included Parylene C; is that
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`correct?
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` A That is correct. They didn't contain
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`Parylene C. But they did contain polymeric coatings
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`on the rubber stopper that required toxicological
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`risk assessment.
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` Q Okay. And those polymeric coatings on
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`the rubber stopper were commonly used in the
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`prefilled syringe industry; is that right?
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`of 2021.
` Q Okay. So prior to the summer of 2021,
`you had never conducted a toxicological risk
`assessment for a syringe, right?
` A That's correct.
` Q Okay.
` A But I had conducted toxicological risk
`assessment of what I'm classifying as high-risk
`devices with direct systemic or direct tissue
`exposure for chronic exposure durations.
` So the principles of conducting those
`toxicological risk assessments and safety
`assessments would go the same for an intravitreal
`injection as for, for example, dialysis equipment
`that would be used for over ten years, three days a
`week, in direct contact with patients' blood.
` So the principles of toxicological risk
`assessment for those two scenarios would be similar
`to a certain extent, and that extent is what is
`discussed in my declaration.
` Q Okay. And the two syringes you've worked
`on, were they both prefilled syringes?
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` A Yes, that is correct.
` Q Okay. And what were they prefilled with?
` A They are prefilled with drug
`formulations. I'm not at liberty to say what the
`drug formulations were due to confidentiality
`agreements with the ultimate clients there. But
`different -- one was a biologic material, I can say.
`The other was a small molecule drug product.
` Q Was the biologic material a VEGF
`antagonist?
` A No, it was not. It was a protein-based
`material.
` Q Okay.
` A But not a VEGF antagonist.
` Q Did either of the -- well, let me ask
`this first.
` So you've completed one of those
`evaluations, and the other one is still ongoing; is
`that right?
` A Yes, that is correct.
` Q Okay. And did either of those prefilled
`syringes include Parylene C as an ingredient?
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`Transcript of Joel M. Cohen
`Conducted on May 19, 2022
`29
` A Yes, the coatings on the rubber stopper
`were commonly used. Not for my clients, though.
`But yes, commonly used.
` Q Okay. And did either of the prefilled
`syringes you worked on include silicone oil?
` A Yes, silicone oil was a component of the
`prefilled syringes that I assessed.
` Q Okay. And did you assess the
`toxicological impact or the potential for a
`toxicological impact of silicone oil?
` A Yes. I risk-assessed the toxicological
`risks associated with potential extractible
`components of the silicone oil and leachable
`components.
` Q And were either of the prefilled syringes
`that you worked on intended for intravitreal
`administration?
` A They were intended for subcutaneous
`administration.
` Q Okay. And what is silicone oil?
` MR. PEPE: Object to form.
` Q Well, let me ask it this way.
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`silicone oil was not a part of my assessment.
` Q So you don't know whether it served the
`function of a lubricant in those prefilled syringes?
` A It might have.
` Q But you don't know one way or the other?
` A It likely did, but I don't know. It
`wasn't a part of my assessment.
` Q Okay. Do you have an understanding of
`the chemical structure of silicone oil?
` A It's my understanding it's a mixture of
`poly(dimethylsiloxane), various chain length
`molecular weight. It's a mixture. It has various
`physical chemical properties that make it an
`excellent lubricant, including its hydrophobicity,
`which means that it repels water, so it's able to
`remain adherent to surfaces. And I'm also aware of
`its toxicological hazard properties.
` Q And what are its toxicological hazard
`properties?
` A It's relatively unreactive, rapidly
`cleared from the body, relatively tolerated in
`various tissues.
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` You said that you conducted a risk
` Q Silicone oil, it's not an elastomer,
`assessment of these prefilled syringes that included
`right?
` A So an elastomer being sort of rubber
`silicone oil, and part of that involved analyzing
`types of materials, silicone oil is not that.
`potential extractible and leachable components from
`the silicone oil, right?
` Q In your declaration, you provided a copy
` A Yes, that's correct.
`of your CV; is that correct?
` A Yes, that's correct.
` Q Okay. And in the course of that work,
`did you develop any understanding of the chemical or
` Q And that begins on page 1108.027; is that
`physical properties of silicone oil?
`right?
` A Yes, potential biological reactivity or
` A Yes, that's correct.
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`lack thereof was a part of my risk assessment.
` Q Okay. And did you prepare this copy of
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` Q Okay. And is silicone oil a liquid or a
`your CV?
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` A Yes. This is my CV.
`solid? I'll start there.
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` A Silicone oil is a liquid.
` Q And did you prepare it personally?
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` A It was prepared at my direction.
` Q Okay. And what was the purpose of
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`silicone oil in the prefilled syringes that you were
` Q By whom?
`16
` A By Gradient staff.
`analyzing?
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` MR. PEPE: Object to form.
` Q Okay. And have you reviewed it to ensure
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` A That was not an area of my review. All I
`its accuracy?
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`knew is that it was a material of composition in the
` A Yes, I have.
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`syringe, and I was risk-assessing the extractible,
` Q And is it accurate?
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`leachable chemical data. So the application of the
` A Yes, it's accurate.
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`Transcript of Joel M. Cohen
`Conducted on May 19, 2022
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` Q Okay. And is it up to date? Is it
`current?
` A It was up to date as of the date listed
`here, which I believe is February 23rd, 2022.
` Q Okay. Is there anything that you would
`add to it today to make it more reflective of your
`current experience?
` A Well, for example, that other prefilled
`syringe risk assessment I was contracted to begin is
`not described in the CV.
` Q Okay. But other than that, it's
`generally still accurate today?
` A For the purposes of this, yes, it's fine.
` Q Okay. So, for example, you list a number
`of papers that you've published beginning on
`page 1108.030.
` Do you see that?
` A Yes, I see that.
` Q Okay. And are these publications up to
`date?
` A Yes, that's up to date.
` Q And same, turning to the couple pages
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`9 (33 to 36)
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`prefilled syringes?
` MR. PEPE: Object to form.
` A I want to give a precise answer. So I'm
`just taking a closer look at some of the listings.
` It's safe to say that none of the
`publications specifically focus on prefilled
`syringes.
` Q Okay. Do any of the publications or
`presentations focus on syringes generally?
` A To the extent that publications and
`presentations discussing toxicological risk
`assessment of extractables and leachables, deriving
`acceptable daily exposures or permissible daily
`exposure levels for pharmaceuticals, such as those I
`presented at the American College of Toxicology
`conference as well the Society of Toxicology
`conference, those, while not directly and explicitly
`related to prefilled syringes, they -- the methods
`described would be applied to risk-assessing a
`prefilled syringe.
` Q So maybe let me ask it a little more
`specifically, then.
`
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`later, page 33, you have a number of presentations
` Do any of the publications or
`listed.
`presentations that you've given focus specifically
`