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`Page 1
`UNITED STATES PATENT AND TRADEMARK OFFICE
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
` --------------------------------------------------
`
` Collegium Pharmaceutical, Inc.,
`
`Petitioner,
`
`Case No.
`PGR2018-00048
`
`-vs-
`
` Purdue Pharma L.P., Purdue Pharmaceuticals L.P.,
` and the P.F. Laboratories, Inc.,
`Patent Owner.
` --------------------------------------------------
`DEPOSITION
`OF
`WALTER G. CHAMBLISS, Ph.D.
`January 9, 2019
`Minneapolis, Minnesota
`--------------------------------------------------
`
` Job No. 153672
` Reported by: Amy L. Larson, RPR
`
`TSG Reporting - Worldwide 877-702-9580
`
`Purdue 2029
`Collegium v. Purdue, PGR2018-00048
`
`

`

`Page 2
`
`Page 3
`
`CHAMBLISS
`APPEARANCES:
` JONES DAY
` 250 Vessey Street
` New York, New York 10281
` By: Gasper LaRosa, Esq.
`
` ROBINS KAPLAN
` 800 LaSalle Avenue
` Minneapolis, Minnesota 55402
` By: Christopher Pinahs, Esq.
` Jake Holdreith, Esq.
`
`Page 4
`
`CHAMBLISS
`THE DEPOSITION OF WALTER G. CHAMBLISS, Ph.D.,
`taken on this 9th day of January, 2019, at
`Robins Kaplan, 800 LaSalle Avenue, Suite 2800,
`Minneapolis, Minnesota, commencing at
`approximately 8:38 a.m.
`
` WALTER G. CHAMBLISS, Ph.D.,
` a witness in the above-entitled action,
` after having been first duly sworn, was
` deposed and says as follows:
`
`EXAMINATION
`BY MR. LAROSA:
`Q. Would you state your name for the record.
`A. Walter Galloway Chambliss.
`Q. Are you employed?
`A. Yes.
`Q. Where are you employed?
`A. The University of Mississippi.
`Q. And you understand you're here as an expert
`witness today?
`A. Yes.
`Q. And when did you first start working on this
`project that ended up with you putting a
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`CHAMBLISS
`
`INDEX:
`EXAMINATION BY: PAGE
`Mr. LaRosa.......................................4
`EXHIBITS MARKED FOR IDENTIFICATION:
`Exhibit 2025....................................99
`Handbook of Pharmaceutical Excipients
`Sixth Edition
`No Bates
`
`Exhibit 2026...................................107
`Handbook of Pharmaceutical Excipients
`Second Edition
`No Bates
`PREVIOUSLY-MARKED EXHIBITS:
`Exhibit 1001...................................17
`U.S. Patent 9,693,961
`No Bates
`Exhibit 1002...................................45
`Declaration of Walter G. Chambliss, Ph.D.
`No Bates
`Amended Exhibit 1002............................8
`Amended Declaration of Walter G. Chambliss, Ph.D.
`No Bates
`Exhibit 1046...................................49
`Patent Application
`Publication No. US 2011/0142943
`No Bates
`
`Exhibit 2001..................................174
`Declaration of
`Panayiotis P. Constantinides, Ph.D.
`No Bates
`Exhibit 2008..................................142
`Inactive Ingredient Guide
`No Bates
`
`Page 5
`
`CHAMBLISS
` declaration in?
`A. I don't recall the specific date.
`Q. Do you recall the year?
`A. We're in '19, probably sometime in 2017, I
`would guess.
`Q. And was it somebody from the Robins Kaplan
`firm that contacted you?
`A. Yes.
`Q. Okay. Have you worked with them before?
`A. No.
`Q. This isn't the first time you've acted as an
`expert witness, correct?
`A. Correct.
`Q. And how many times would you say you've
`worked as an expert witness in a patent case?
`A. I'm guessing over the last 18 years, maybe
`20, 25, 30 at the most.
`Q. In any of those cases did you work on behalf
`of an innovator company?
`A. Yes.
`Q. Okay. How many times?
`A. Again, I'm guessing maybe five to ten.
`Q. Have you ever worked for Purdue?
`A. No.
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`2 (Pages 2 to 5)
`TSG Reporting - Worldwide 877-702-9580
`
`Purdue 2029
`Collegium v. Purdue, PGR2018-00048
`
`

`

`Page 10
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`CHAMBLISS
` found in the '534 provisional, is the only
` instance in the priority chain where C12
` through C40 fatty acid is referenced by name."
`A. Correct.
`Q. Is that -- that's not a true statement,
`correct?
`A. No. As I've testified, I found stearic acid
`named in the '534 provisional.
`Q. If you'd look at paragraph 109 of the
`original declaration.
`A. Okay.
`Q. And in that paragraph it says that the
`provisional does not name any C12 to C40 fatty
`acids by name. That's -- that was also
`incorrect; is that right?
`A. Yes. As I testified, stearic acid is named.
`Q. Okay. Are you aware of any -- anything else
`that was in the original declaration that you
`believe not to be correct?
`A. Yes.
`Q. Okay. Can you tell me what that is?
`A. Yeah. After reading -- I can't pronounce his
`name -- Dr. Constantinides' declaration, and
`looking at the literature, I listed four
`
`Page 12
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`CHAMBLISS
` a PGG, so I would add that.
`Q. So let me just make sure I'm understanding
`this correctly. 5518, 5402, 4301, 3901 and
`3301 are now -- it's your understanding are
`not PGGs?
`A. Right. They don't have the five constituents
`that a PGG has.
`Q. How, if at all, does that affect your -- any
`of your opinions?
`A. Not at all. Looking at the documents in
`record, there was three I could add. There
`were other trade names, as I said, in my
`declaration. Gelucire is just one of other
`trade names that PGGs are sold under. So I
`could come up with a longer list, but I think
`the list now is fine. It doesn't change my
`opinion.
`Q. It doesn't change your opinion as to the
`number of combinations there are?
`A. I'm fine with this number -- it doesn't
`change my opinion that the claims not
`enabled, there would be undue
`experimentation.
`Q. How did you evaluate how much experimentation
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`CHAMBLISS
` Gelucires that are not PGGs. So I would take
` those out of my amended declaration as well
` as the original declaration.
`Q. Okay. So then let's take a look at your
`amended declaration.
` Do you recall where in the amended
` declaration this was discussed?
`A. Not off -- I'll have to look at the table of
`contents and maybe I'll find it. It's where
`PGGs were discussed.
`Q. So, for example, there's some discussion on
`page 46.
`A. Yes, that would be it.
`Q. And you provide there a list of what you say
`are PGGs that were known in the art?
`A. Yes.
`Q. And which one -- which ones of those are
`you -- is it not your testimony are not PGGs?
`A. I wrote them down, because I didn't memorize
`them. Is that okay if I give you what I
`wrote down?
`Q. Of course.
`A. 3301, 3901, 5518 and 4301. And then looking
`at the literature, I believe also 5402 is not
`
`Page 13
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`CHAMBLISS
` would be undue experimentation?
`A. Based on my experience, 30 years working in
`pharmaceutical sciences, about half of that
`being in industry where I supervised groups
`of formulators that would fit under the POSA
`definition, now at the University supervising
`again the graduate students who are the new
`group of POSAs. I have a lot of experience
`putting together time and cost estimates.
`Q. Okay. So what in particular went into your
`evaluation as to what amount of
`experimentation would be undue?
`A. Well, it's really the unpredictability of
`using those ingredients in combination. And
`Claim 1 doesn't give you any direction which
`fatty acids, you could use combinations of
`fatty acids, which PGGs, as we agreed there's
`at least -- I don't know what we are down to
`now, 12 or so on this list, which one of
`those, what concentration, no concentration
`for the active ingredient.
`Q. You're familiar with the Handbook of
`Pharmaceutical Excipients, correct?
`A. Yes.
`
`4 (Pages 10 to 13)
`TSG Reporting - Worldwide 877-702-9580
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`Page 34
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`CHAMBLISS
`
`A. Yes.
`Q. And in those cases how long did it -- how
`long does it typically take for the generic
`company to take a formulation with the same
`exact excipients as the innovator and
`complete all the testing that would be
`necessary to file the ANDA?
`A. For a 12-hour formulation? I think it's got
`to be an extended-release formulation to make
`that comparison.
`Q. Sure.
`A. You're never able to copy exactly. You can
`get as close as you can. I've seen it be 9
`months, I've seen it be 18 months, I've seen
`it be 6 months at the shortest.
`Q. Okay. And in your estimate, what type of
`team would -- how many people would be
`assembled on a team where you were trying to
`copy what the innovator did and come up with
`a generic formulation?
`A. That varies.
`Q. How -- from what to what? Is it ever less
`than five people?
`A. It depends on what you're counting as the
`
`Page 36
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`CHAMBLISS
`Q. Okay. So 10 people working 40 hours a week
`is 400 hours, correct?
`A. Yes.
`Q. And 400 hours into 1,200 hours is 3 weeks,
`correct?
`A. No, they're not all working at the same time.
`Q. Well, I understand. I'm talking about just
`if they were all working at the same time.
`A. That's not -- that's impossible.
`Q. Okay.
`A. You don't have a formulation, so there's
`no -- nothing for the analytical chemist to
`do. You don't have a formulation, there's
`nothing for the pharmacokinetics person to
`do. You don't have a formulation, so you
`can't manufacture it. So it's all
`sequential.
`Q. Understood.
`A. There's a lot of trial and error where a
`formulation is made, analytical runs it, it
`doesn't meet the criteria, the formulation
`gets remade, so that's why I say it's a
`minimum of six months, more commonly a year.
`Q. To copy a generic product?
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`CHAMBLISS
` team. Are you counting just formulators?
`Q. I'm counting the team as you've laid it out
`here, the formulation scientists, the process
`development scientists, the analytical
`scientists, the person involved in the design
`and conduct of the clinical-abuse studies.
`A. I would say 15 to 20.
`Q. Fifteen to 20 people.
`So 15 to 20 people, let's -- let's
`say on the conservative side 15 people.
`A. And you're talking about for that generic
`that I know the ingredients?
`Q. I know the ingredients.
`A. All I've got to do is figure out the amounts
`and then I need to make it meet the
`criteria --
`Q. Right.
`A. -- using dissolution and bioequivalence?
`Q. Right.
`A. Yeah, maybe 10 to 15.
`Q. Okay. So let's say it's 10 people. You
`agree that would probably the smallest team
`of people that would be involved?
`A. Yes.
`
`Page 37
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`CHAMBLISS
`A. For a 12-hour formulation, yes.
`Q. Okay. So if it normally takes --
`A. Sorry, that's just to have the study
`conducted and say yes, I've got it. Now
`you've got to do all your stability, you've
`got to do your process validation, you've got
`to do all the regulatory filing, so that's
`why it's 18 months.
`Q. Okay. So if it takes, let's say, a year to
`copy an innovative product when you have all
`the ingredients and you --
`A. You --
`Q. Let me finish my question.
`A. Okay.
`Q. If it takes you a year knowing all the
`ingredients and all you have to do is figure
`out the amounts and do the studies to make a
`generic version of an innovative product, how
`can it be undue experimentation to take eight
`months to solve this problem?
`A. Because as I said the whole uncertainty,
`unpredictability of this that the exercise
`you asked me to go through was I know the
`excipients and I know my goal,
`
`10 (Pages 34 to 37)
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`

`

`Page 38
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`CHAMBLISS
` bioequivalence.
`Q. Right.
`A. And then it's a time -- it takes that much
`time to do it. Here I don't have that goal,
`I don't know the excipients.
`Q. Doesn't the bioequivalence make it harder,
`not easier? I mean, doesn't it make it --
`yeah, let me put it this way: If I have to
`make my product bioequivalent to an
`innovative product, that's another
`requirement on top of the one that would be
`required to make the claim formulation,
`correct?
`MR. PINAHS: Object to the form.
`THE WITNESS: I don't understand
`
` that.
`BY MR. LAROSA:
`Q. If I'm just trying to make the claimed
`formulation, I don't have to make it
`bioequivalent to anything else, I just have
`to make it within the scope of the claims,
`make it for 12-hour release and make it
`abuse-deterrent.
`A. Well --
`
`Page 40
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`CHAMBLISS
`A. To get FDA -- again, you're comparing apples
` to oranges. To get FDA approval, yes.
` That's the whole purpose of a generic
` product, to get FDA approval.
`Q. Let me ask it this way: Would it take more
`than 1,200 hours to get to the point where
`you could file your ANDA?
`A. Probably, yes. Now you're talking about
`bringing in regulatory, you're bringing more
`people in, you're bringing in the commercial
`people, you're bringing in marketing, you're
`bringing in labeling, so you're bringing in a
`much larger team.
`Q. Okay. So if it's more difficult -- I think
`you testified earlier you didn't think it was
`undue experimentation to make a generic
`product, correct?
`A. I don't remember testifying that.
`Q. Do you believe it's -- it would take undue
`experimentation to copy an innovator's
`product and file an ANDA?
`A. I don't think so under that -- that question,
`I don't think so. I need to know
`specifically what product you're talking
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`CHAMBLISS
`Q. -- if I was making a generic product, I also
`have to do all that and make it
`bioequivalent, correct?
`A. Okay. So let me just make sure I understand
`your question. So forget about FDA approval,
`making -- making the formulation out of '961,
`that's not an issue?
`Q. You didn't assume you had to make a product
`that was FDA approvable when you did your
`analysis, correct?
`A. No.
`Q. Okay. So do you agree that it would be more
`difficult for a generic to make their product
`and make it bioequivalent than it would be to
`practice the '961 patent?
`A. Absolutely not. Much more difficult to
`practice the '961 patent.
`Q. Okay. In what way?
`A. In all the uncertainty and unpredictability.
`You've got to have 12-hour release in the
`body and you've got to have abuse-deterrent
`for the full scope of those claims.
`Q. Would you agree it would take at least 1,200
`man hours to make the generic product?
`
`Page 41
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`CHAMBLISS
`
` about.
`Q. I'm assuming a 12-hour opioid formulation.
`Let's say somebody wants to just make a
`generic version of OxyContin, they want to
`copy exactly the ingredients that are in
`OxyContin, use the available information
`that's out there and make that product, you
`don't think it would take undue
`experimentation to make that formulation,
`correct?
`A. Not under the -- under the legal term of
`undue experimentation, no. But that's --
`Q. Okay.
`A. It may take 18 months to do it because of all
`the hoops you've got to go through to get FDA
`approval.
`Q. Okay. So what is it about -- are you
`saying -- let me ask you this: Is it your
`opinion it would take longer to make the
`claimed formulation than it would take to
`bring a formulation to the point where you
`could file an ANDA if you were a generic?
`MR. PINAHS: Objection to form.
`THE WITNESS: Again, I don't think
`
`11 (Pages 38 to 41)
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` 2001 and it's later, then the 2011 could be.
` So under my anticipation analysis, I had
` assumed that it was prior art.
`Q. Okay. So for your anticipation analysis, you
`assumed that 1046 is prior art, correct?
`A. Yes.
`Q. For your enablement argument did you assume
`that Exhibit 1046 is prior art?
`A. For my -- yes.
`Q. Okay. And --
`A. I think I did it both ways, looked at the
`2001 date and 2016 date.
`Q. Okay.
`A. Or '17.
`Q. So in a world where Collegium Exhibit 1046 is
`prior art for the purposes of anticipation,
`it would also be prior art for the purposes
`of enablement, correct?
`A. Yes. Yes, the '943 is definitely enabled, so
`yes, it would be.
`Q. Okay. So when you did your enablement
`analysis -- well, let me ask it this way: In
`your expert report you have a section where
`you say the patent is not enabled; is that
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`CHAMBLISS
` prior art, correct? And when I mean the
` enablement analysis, I'm talking about the
` one that starts on page 90.
`A. Yes, for that -- that we just talked about,
`yes.
`Q. Okay. And is it your opinion that
`Exhibit 1046 enables a person of ordinary
`skill in the art to practice the invention?
`A. Practice which invention?
`Q. The '961 claimed invention.
`A. Not for the full scope of the claims, no.
`Q. Okay. Does it enable a person of ordinary
`skill in the art to practice an embodiment of
`the claims?
`A. Yes, I think it would.
`Q. Okay. What embodiment of the claims does it
`allow a person to practice?
`MR. PINAHS: Objection to form.
`THE WITNESS: It would be an
` embodiment that consists of a specific --
` like, for example, Example 1 of the '943
` teaches an Oxycodone base with two fatty
` acids, the beeswax and carnauba wax. Sorry,
` page 11, Example 1. The only ingredient
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`
` right?
`A. Yes.
`Q. And for the purposes of that analysis, what
`did you assume the priority date of the
`patent was? And when I say, "The patent," I
`mean the '961 patent.
`A. Well, started with the '534 provisional,
`doesn't enable it. So that was assuming the
`'543 -- '534 was the priority date based on
`the face of the patent. And then I looked at
`the other related applications, which as we
`went through the charts, have different
`dates, and then ultimately considered
`the '943.
`Q. I guess I'm asking specifically about on
`page 90 you have an opinion that the '961
`patent is invalid for lack of enablement.
`And in that analysis, what did you assume the
`priority date was?
`A. I said paragraph 2 -- 209 as the effective
`filing date, that would be February 4th,
`2016, is the effective filing date.
`Q. Okay. So for the purposes of your enablement
`analysis, you assumed that Exhibit 1046 was
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`CHAMBLISS
` that's missing there is the PGG, but the '943
` discusses PGGs. So --
`BY MR. LAROSA:
`Q. So -- I'm sorry, go ahead.
`THE WITNESS: I think that would
` be the type of embodiment I'm thinking of.
`MR. LAROSA: Okay.
`BY MR. LAROSA:
`Q. And it's your opinion that it wouldn't take
`undue experimentation to add PGG to that
`formulation, correct?
`A. Not with all the teachings that are in
`the '943. You've eliminated many of the
`variables that I've discussed.
`Q. If you'd take a look at Claim 2 of the '961
`patent. Claim 2 is directed to the method of
`Claim 1 that's -- comprises an organic salt
`of Oxycodone, correct?
`A. Correct.
`Q. That's not Oxycodone base, correct?
`A. Correct.
`Q. And is it your opinion that it wouldn't take
`undue experimentation to take what's in
`Example 1, switch to an organic salt of
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` Oxycodone, and add PGG?
`A. Based on the teachings in the '943, I do not
`think it would be undue experimentation.
`Q. Okay.
`A. There's definitely experimentation in this
`report.
`Q. What teachings are in the '943 that are not
`in the '961 that allow you to do that?
`A. A lot. Exact specific formulation, specific
`ingredient, specific amounts, specific
`manufacturing instructions.
`Q. What in particular?
`A. Well, just looking at -- at the example we
`just talked about, Example 1 tells me in
`Table 1, page 11, how much Oxycodone base,
`how much myristic acid, how much stearic acid
`or stearic acid, how much beeswax, how much
`carnauba wax. And then carrying over to page
`12, it's got the manufacturing procedure in
`detail.
`Example 2 then has the testing from
`having crushed those particulates, which is
`important for abuse-deterrent determination.
` Example 3 is another formulation, a
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`CHAMBLISS
` laundry list of ingredients, there's
` unbounded claims that just list ingredients
` with no amounts.
`BY MR. LAROSA:
`Q. It's your opinion there's no formulations in
`the '961 patent?
`A. No, that are formulations that have an active
`ingredient, that's Oxycodone or salt, PGGs,
`C12 to C14 fatty acids or mixture thereof,
`carnauba wax and beeswax. That's a
`homogenous mixture that has the functional
`requirements that are in the claim. There
`are -- there's no teachings for that.
`Q. There's also no teachings in the '943 for
`that; isn't that right?
`A. What's missing is the PGG. You're making the
`particles and it does have abuse-deterrent
`testing. I think there's a lot more
`information in the '943.
`Q. Are you saying -- so we take a look at
`Table 1, Example 1 of the '943. There's four
`different compositions that are laid out
`there, right?
`A. Correct.
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` very specific formulation telling me how much
` Oxycodone base, telling me how much myristic
` acid, how much beeswax, how much carnauba
` wax. It's got a detailed procedure of how to
` manufacture starting at paragraph 131.
` I could keep going on, but there's
` many examples and specific details that are
` not in the '961.
`Q. How many examples -- or how close would the
`examples have to be to the claim formulation
`in order for there not to be undue
`experimentation required?
`MR. PINAHS: Objection to form.
`THE WITNESS: Well, there's no --
` would you repeat the question, please.
`BY MR. LAROSA:
`Q. How close to the formulation in the '943
`patent would there have to be in order for
`there not to be undue experimentation
`required in order to get to the formulation
`in the '961 patent?
`MR. PINAHS: Same objection.
`THE WITNESS: Again, there's no
` formulation in the '961 patent. There's a
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`CHAMBLISS
`Q. And what, if anything, can you determine
`based on the different compositions that were
`tested about the amount of Oxycodone base
`that should be used?
`A. The amount -- there's two amounts, 5 grams or
`10 grams. There's two different
`concentrations. The data I think you're
`asking about is in Example 2 where they've
`made -- made tablet formulations.
`Q. Is there any --
`A. Formulation A releases 31.6 percent of
`Oxycodone; Formulation B released
`19.7 percent; Formulation C, 14.8 percent;
`Formulation D, 18.2 percent, compared to
`OxyContin, which was the control releasing
`95.6 percent. So it's giving me a lot of
`information there about the effect of the
`formulation and the variation -- minor
`variation of ingredients has on release of
`Oxycodone from the formulation.
`Q. So this is the drug release in crushed
`tablets, correct?
`A. Correct.
`Q. Is there any drug release data -- is there
`
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`CHAMBLISS
` any dissolution data on intact tablets?
`A. I don't recall. We'd have to look.
`Q. Is there any pharmacokinetic data, for
`example?
`A. I don't recall any pharmacokinetic data, but
`I need to look. (Reviews document.)
`I discuss the pharmacokinetics in
`paragraph 21, page 2. It says, "Provide a
`therapeutic effect for extended-release of
`time, typically 6 to 24 hours, preferably 12
`to 24 hours."
`Q. Is it your opinion that that general
`disclosure in the summary of the invention
`would make a person of ordinary skill in the
`art believe that the specific formulations in
`the example released over those time periods?
`A. Yes.
`Q. Okay. So if there's general disclosures in
`the '961 patent about releasing drug over
`those time periods, they would believe that
`all the examples and descriptions of the
`formulations in that patent would also
`release over the time periods disclosed in
`the '961 patent, correct?
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`CHAMBLISS
`Q. So it's not unpredictable in the context of
`the '943 patent to vary the ingredients in
`Example 2 in order to change the release
`characteristics?
`A. You mean Example 1?
`Q. Example 1 and 2.
`A. No, they -- this table that they have,
`Table 1 is doing exactly that, it's varying
`the amounts -- it's varying the type of fatty
`acid, it's varying the amounts of the fatty
`acid and the amount of carnauba wax.
`Q. You think that the way they're varying them,
`these ingredients is something that wouldn't
`have been understood by a person of ordinary
`skill in the art?
`A. Would not have been understood?
`Q. Right.
`A. I don't understand that question.
`Q. Is it your opinion that persons of ordinary
`skill in the art would not have known how to
`vary the ingredients in Example 1 in order to
`change the release characteristics?
`A. No, they would have known how to do that. If
`you tell one of my graduate students take
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`CHAMBLISS
`
`A. No.
`Q. And why is that?
`A. Well, this is talking about 6 to 24 hours.
`And looking at the examples based on what a
`person of ordinary skill in the art knows
`about Oxycodone and other extended-release
`formulations, I believe they would believe
`these specific examples would be 6 to 24
`hours.
`Q. Okay. Would it be 6 or 24 hours?
`A. That they wouldn't know until they tested it.
`Q. Okay. So you wouldn't know if Example 2
`releases for at least 12 hours, correct?
`A. You would -- you wouldn't know until you run
`dissolution on it, and then you'd have a
`pretty good idea. And then you would test
`it, and if you needed to vary the
`formulation, you would know how to do that.
`Q. Okay.
`A. You would know the ratio of the Oxycodone to
`the waxes. You would vary that ratio, add
`more wax in proportion to Oxycodone if you
`need to extend it longer, put less wax if you
`need to have it shorter.
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`CHAMBLISS
` Oxycodone base, myristic acid, stearic acid,
` yellow beeswax, carnauba wax and come up with
` a design of experiments where I want you to
` vary the type of fatty acid and I want you to
` vary the amount of the fatty acid in waxes
` and run dissolution, they would now how to do
` that easily.
`Q. Do the claims require the drug to release for
`more than 12 hours in a dissolution test or
`in vitro?
`A. Which claims are we talking?
`Q. The '961 claims.
`A. No, there's no guidance at all about drug
`release.
`Q. So you didn't -- when you did your analysis
`of the '961 claims, what was your
`understanding of the portion of those claims
`that required providing a therapeutic effect
`for about 12 hours or longer when orally
`administered to a human patient?
`MR. PINAHS: Object to form.
`THE WITNESS: I didn't understand
` the question, sorry.
`BY MR. LAROSA:
`
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`CHAMBLISS
` formulations with carnauba wax in the past;
` is that right?
`A. Yes.
`Q. And is the same true with beeswax?
`A. Yes.
`Q. And did that work occur before 2001?
`A. Yes.
`Q. Is it also true that you've prepared or
`supervised the preparation of formulations
`with stearic acid?
`A. Yes.
`Q. And that was before 2001?
`A. Yes.
`Q. And myristic acid, did you also use that?
`A. Yes, I believe so.
`Q. And did you prepare formulations or supervise
`the preparation of formulations with PGGs
`before 2001?
`A. Yes.
`
`MR. PINAHS: Counsel, are we going
` to continue the exhibit numbers that we have
` in the record right now or are we going to --
`MR. LAROSA: I'd be happy to, bu I
` don't -- I'm not familiar with what those
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`CHAMBLISS
` it describe the use of PGGs?
`A. The word PGGs is not in here anywhere, but
`that's -- the name has changed over time to
`polyoxylglycerides. So with that
`understanding, yes.
`Q. Okay. So this version is from the sixth
`edition and was published in 2009?
`A. Correct.
`Q. And according to this entry, the date of this
`revision was 3 March of 2009, correct?
`A. Yes.
`Q. Now, there's a list of categories on the
`right-hand side, including a number of
`different subcategories. Do you consider
`those all to be PGGs?
`A. Yes. This -- yes. So there's one, two,
`three, four, five types of PGGs in this.
`Q. And if we take a look at Section 6, there's a
`description of the functional category?
`A. Yes.
`Q. And for what purpose would a person of
`ordinary skill in the art be looking at the
`description of the functional category of
`these excipients?
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`CHAMBLISS
` numbers are.
`MR. PINAHS: Do you want to give
` me the number so we can stay on the same
` page?
`
`MR. LAROSA: I'd be happy to do
` that. We can remark the exhibit.
`MR. PINAHS: The next exhibit
` number would be 2025.
`(Whereupon, Exhibit 2025 was
`marked for identification.)
`BY MR. LAROSA:
`Q. Do you have Exhibit 2025 in front of you?
`A. I do.
`Q. And do you see that it's the sixth edition,
`or a portion of the sixth edition of the
`Handbook of Pharmaceutical Excipients?
`A. Yes.
`Q. And you're familiar with the Handbook of
`Pharmaceutical Excipients?
`A. Yes.
`Q. And is it commonly used by persons of
`ordinary skill in the art?
`A. Yes.
`Q. And this portion that we're looking at, does
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`CHAMBLISS
`MR. PINAHS: Objection to form.
`THE WITNESS: In general, just to
` look to see what any excipients in the
` handbook has been used for in the literature.
`BY MR. LAROSA:
`Q. And it's described as a dissolution enhancer,
`correct?
`A. Yes.
`Q. And also as an emulsifying agent?
`A. Yes.
`Q. What's an emulsifying agent?
`A. A surfactant, it had to be. But in this
`case, a surfactant that holds the oil and
`water together to make an emulsion, or helps
`to hold it together.
`Q. And it also refers to non-ionic surfactant
`separately. Does that have a different
`meaning as far as function goes?
`A. No. That's a chemical definition rather than
`a functional definition.
`Q. Next it talks about its use as a penetration
`agent?
`A. Yes.
`Q. What's a penetration agent?
`
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` glycerides, mono-, di- and tri-, and three
` fatty acid glycerides, mono- and di- and
` tri-, and two polyethylene glycol esters,
` mono- and di-. So you have to have all five.
`Q. Okay. What other fatty acid -- fatty acid
`esters are described specifically in
`the '961?
`A. They didn't describe any fatty acid esters
`specifically, I don't think.
`Q. PGG is not a fatty acid ester?
`A. It's a fatty acid ester with fatty acid
`glycerides, and it's a fatty acid ester
`that's a mono and a di, and the fatty acid
`glyceride is a mono, di and tri.
`Q. Are you aware of any excipients described in
`the '961 specification that is both a fatty
`acid ester, fatty acid glyceride, mono, di
`and tri glyceride other than PGGs?
`MR. PINAHS: Objection to form.
`THE WITNESS: An ingredient that
` has all five?
`MR. LAROSA: Yes.
`THE WITNESS: I haven't looked for
` it, but PGG was just listed once. I assume
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`CHAMBLISS
`A. But they listed Tweens, they listed Spans.
`They listed a lot of other surfactants that
`are comparable from what I was saying to if
`they had listed Gelucire.
`Q. If we look further up in column 16.
`A. Okay.
`Q. At the very beginning in that first paragraph
`it's, "Identifying natural and synthetic
`waxes as preferred binder materials,"
`correct?
`A. If -- if you're adding a binder, you've got
`to understand that column 15, when it starts
`talking about matrix, is talking about the
`ingre