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` UNITED STATES PATENT AND TRADEMARK OFFICE
`----------------------
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
`----------------------
`AMNEAL PHARMACEUTICALS LLC,
`Petitioner,
`v.
`ALKERMES PHARMA IRELAND LIMITED,
`Patent Owner.
`
`-----------------------
`Case IPR2018-00943
`Patent No. 7,919,499
`----------------------
`DEPOSITION OF KINAM PARK, Ph.D.
`Westfield, New Jersey
`Wednesday, January 23, 2019
`
`Reported by:
`Angela M. Shaw-Crockett, CCR, CRR, RMR, CSR
`Job No. 154180
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`ALKERMES EXHIBIT 2025
`Amneal Pharmaceuticals LLC v. Alkermes Pharma Ireland Limited
`IPR2018-00943
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` UNITED STATES PATENT AND TRADEMARK OFFICE
`----------------------
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
`----------------------
`AMNEAL PHARMACEUTICALS LLC,
`Petitioner,
`v.
`ALKERMES PHARMA IRELAND LIMITED,
`Patent Owner.
`
`-----------------------
`Case IPR2018-00943
`Patent No. 7,919,499
`----------------------
`DEPOSITION OF KINAM PARK, Ph.D.
`Westfield, New Jersey
`Wednesday, January 23, 2019
`
`Reported by:
`Angela M. Shaw-Crockett, CCR, CRR, RMR, CSR
`Job No. 154180
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`ALKERMES EXHIBIT 2025
`Amneal Pharmaceuticals LLC v. Alkermes Pharma Ireland Limited
`IPR2018-00943
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` January 23, 2019
` 9:00 a.m.
`
`DEPOSITION, held at Lerner, David, Littenberg,
`Krumholz & Mentlik, LLP, 600 South Avenue West,
`Westfield, New Jersey, before Angela M.
`Shaw-Crockett, a Certified Court Reporter,
`Certified Realtime Reporter, Registered Merit
`Reporter and Notary Public of the States of New
`York, New Jersey and Connecticut.
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` K. Park
` A P P E A R A N C E S:
`
`PAUL HASTINGS
` Attorneys for The Petitioner
` 200 Park Avenue
` New York, New York 10166
`BY: JOSEPH O'MALLEY, ESQ.
` GERARD SALVATORE, ESQ.
`
`LERNER, DAVID, LITTENBERG,
`KRUMHOLZ & MENTLIK
` Attorneys for The Patent Owner
` 600 South Avenue West
` Westfield, New Jersey 07090
`BY: TEDD Van BUSKIRK, ESQ.
` NICHOLE VALEYKO, ESQ.
`
`ALSO PRESENT:
` John Kirkland, Director, Intellectual Property
` ALKERMES, INC.
` ** ** **
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` K. Park
`K I N A M P A R K P h D,
` called as a witness, having first been
` duly sworn, was examined and testified as
` follows:
`EXAMINATION
`BY MR. O'MALLEY:
` Q. Good morning, Dr. Park.
` A. Good morning.
` Q. Could you please state --
` A. I'm so sorry. I forgot my glasses.
` MR. VAN BUSKIRK: Could we take a quick --
` MR. O'MALLEY: Let's go off the record for
` a moment.
` (A discussion was held off the record.)
` (At 9:01 a.m. a recess was taken.)
` (At 9:02 a.m. the deposition resumes.)
`BY MR. O'MALLEY:
` Q. Dr. Park, would you please state your full
`name and home address for the record?
` A. Kinam Park, K-I-N-A-M, P-A-R-K,
`3525 Wakefield Drive, West Lafayette, Indiana 47906.
` Q. I'm going to hand you what is Amneal
`Exhibit 1031, the curriculum vitae of Dr. Park.
` THE COURT REPORTER: So do I need to --
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` MR. O'MALLEY: No, we just refer to the
` pre exhibit numbers.
`BY MR. O'MALLEY:
` Q. And I think I'll also hand you, to talk
`about your background, a copy of Amneal
`Exhibit 1030, the declaration of Dr. Park.
` So let me start with your curriculum
`vitae, Exhibit 1031.
` Is that your current curriculum vitae?
` A. As of February 2018, yes.
` Q. Okay. And since then, have there been
`additions, further publications, or the like?
` A. Yes. Probably more publication and the
`list of presentation at the meetings.
` Q. Any other changes or additions that you
`recall since February?
` A. No.
` Q. Okay. And you're still at Purdue
`University?
` A. Yes.
` Q. And you still have that title that's shown
`on the first page of Exhibit 1031, Showalter
`Distinguished Professor of Biomedical Engineering
`and Professor of Pharmaceutics?
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` A. Yes.
` Q. Now, if you want to turn to your
`declaration for a moment, starting at paragraph 5.
` You state, in paragraph 5, that since
`about 1986, you "have been involved in the research,
`development, and manufacture of pharmaceutical
`formulations and in particular
`controlled/sustained-release drug delivery systems."
` Do you see that?
` A. Yes.
` Q. Now, has any of those efforts resulted in
`an FDA-approved product that you were involved in?
` A. No, not yet.
` Q. Have any of your research and development
`efforts resulted in a candidate for FDA approval?
` A. Candidate in a sense companies have tried,
`but then that candidate -- I don't know whether
`that's what you mean.
` Q. Yeah.
` A. But it was not approved, yeah, at the
`time.
` Q. And how many candidates, using your
`meaning, which was the same as mine, have you been
`involved in research- and development-wise?
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` A. Well, at least a few that I recall. But
`could be a little more, but around three or four.
` Q. And were all these controlled-release
`formulations?
` A. Yes, one of them is actually
`fast-dissolving tablets. So, in a sense, it's
`controlled, controlled to release fast.
` Q. Let's take these three or four candidates
`one at a time.
` What was the earliest such candidate you
`were involved with?
` A. It was gastroretention devices. It is
`based on hydrogels which swells in the stomach for
`long period of time. The stomach -- it swell in the
`stomach very fast so that it can stay in the stomach
`long period of time so that it can release a drug
`over a 12- to 24-hour period.
` Q. And what was the active ingredient?
` A. Active ingredient could be anything,
`because it was a platform that was designed to
`deliver a variety of oral drugs so that it can
`include the drugs. And hydrogel can slowly release
`a drug over time.
` Q. And we were talking about candidates for
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`drug approval.
` Did one such drug in this platform
`technology advance to the clinical stages?
` A. Yes. The drug delivery system itself,
`hydrogel, which I call it gastroretentive devices,
`was tested in human just to prepare for ultimate
`application. So I think it was tested in Phase 1
`clinical trial.
` Q. Okay. And it never became an approved
`drug product that incorporated this platform
`technology?
` A. While it was tested in human, the company
`was sold to another bigger company. So, at the
`time, there was some transition and somehow it was
`lost in the middle, yes. So finally it was not
`ultimately went to Phase 3 or FDA application.
` Q. Okay. So let's talk about the next of the
`three or four candidates you had in mind that you
`personally were involved with.
` What was the next one?
` A. That was the fast-dissolving tablets,
`which is designed to dissolve in the mouth even
`without water. So you can just put the tablet in
`the mouth and the saliva in the mouth is enough to
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`dissolve them. So it's a loaded with fast-released
`drugs.
` Q. And was there a particular active
`ingredient?
` A. Yes. Mostly it was antihistamine drug or
`allergy drugs, so like Zyrtec. Could be other
`allergy drugs that patient needed symptoms relieved
`fast.
` And also diarrhea drug like Imodium, so
`the patients need to have the medicine fast and then
`they can take it without water.
` So number of potential candidates were
`discussed.
` Q. And how far did any of those candidates
`get in development?
` A. Well, again, it was discussion with, at
`the time, Pfizer. Again, the division that I was
`talking to was sold to another company. It was lost
`in the middle too.
` So, since then, I was developing my own
`for -- not drug per se, but like a caffeine. So we
`have a caffeine fast-dissolving tablet formulation.
` Q. Caffeine?
` A. Yes. So you don't have to go to
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`Starbucks, but it has nice flavor and everything in
`tablet. You can just take a tablet in the mouth.
`Then you have caffeine as well as all kinds of
`flavors.
` Q. I think my young attorneys may appreciate
`that when we're at trial.
` MR. VAN BUSKIRK: I don't think Starbucks
` will appreciate that.
`BY MR. O'MALLEY:
` Q. How far did that product get in
`development?
` A. It was manufactured and sold locally too.
`And also, since then, we have been talking with --
`especially military, they said they need some coffee
`for soldiers. It was one of the fast way too. So,
`since then, we have been in discussion to make it --
`supply it to soldiers.
` Q. Did that product require FDA approval?
` A. No. That's why we started this one,
`because it's a nutritional product. So we can
`simply make in good manufacturing practice so that
`it is not a drug per se.
` Q. So then, again going back to three or four
`candidates that you've personally been involved in,
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`the development of which got at least somewhere down
`the road towards drug approval, is there another
`candidate you have in mind?
` A. Yes. I have been working on injectable
`long-acting formulations. And I really cannot
`disclose the kind of drug because it's kind of
`confidential.
` Q. And how far is this drug along in
`development?
` A. We have spent at least several years and
`we are near the point where we can prepare package
`to submit to the FDA for initial talks.
` Q. Okay. Now, this particular long-acting
`injectable formulation, does it include
`poly(lactide-co-glycolide)?
` A. Yes. In fact, that is the -- probably the
`only polymer that most formulation scientists use,
`for a couple of reasons. First, it was the only
`polymer that was used in FDA-approved injectable
`long-acting formulations. There are about 20
`long-acting injectable formulations approved by the
`FDA. They're all based on PLGA, nothing else.
`That's why almost everybody want to use PLGA instead
`of some other polymer.
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` Q. And just so the record is clear, for
`today, when we say "PLGA," we're referring to
`poly(lactide-co-glycolide); is that correct?
` A. That's correct.
`Poly(lactide-co-glycolide) is also called
`poly(lactic-co-glycolic acid). Those two are exact
`the same terminologies.
` Q. So in your research and development since
`about 1986 into development and manufacture of
`pharmaceutical formulations, so far you've not been
`involved in one that's received FDA approval,
`correct?
` A. That's correct.
` Q. And it's very difficult to formulate a
`long-acting -- long-acting controlled-release
`formulation; isn't that true?
` A. Well, "difficult" is relative term. I
`don't know what you really mean by "difficult."
` (Exhibit 2023 was received and marked for
` identification, as of this date.)
`BY MR. O'MALLEY:
` Q. So I'm going to show you what we've now
`marked as Exhibit 2023. And it's an article from
`the Journal of Controlled Release, entitled
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`"Controlled Drug Delivery: Historical perspective
`for the next generation," with authors Yun, Lee, and
`Park.
` And, Dr. Park, you're one of the coauthors
`of this publication; is that correct?
` A. That's correct.
` Q. And this was published in 2015?
` A. Yes.
` Q. And what was your purpose in helping
`prepare this publication?
` A. Oh. The purpose was that if you look at
`the history of controlled or sustained drug delivery
`field, it began 1959, 1960. So the first
`generations, from 1960s up to 1980s, was a very
`productive era because that's the -- that's where
`controlled drug delivery technologies were developed
`and then they produced many controlled or sustained
`drug delivery system, especially in the area of oral
`and transdermal delivery system.
` The next decade, from 1980s up to 2000,
`there were a new formulations, long-acting
`injectable formulations and many other advanced
`formulations. But the point of this article was,
`since then, the whole last about 30 years, whole
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`drug delivery field was occupied by so-called
`nanotechnology or nanomedicine. And they were a lot
`of -- majority of formulation scientists focus on
`tumor-targeted drug delivery.
` Q. I'm sorry. What was that word?
` A. Tumor-targeted drug delivery, because a
`nanoparticle somehow was thought to targeting to
`tumors without any substantial basis.
` So my point was that if you look at the
`result, nanomedicine does not really help to treat
`the tumor any better than controlled. So we have to
`realize the limitation of nanomedicine. Let's look
`at what the problems are and let's find out how to
`overcome this problem.
` So that was the main point of this
`article.
` Q. Now, if you turn to -- oh, let's see.
`There's a category heading on page 5. It's under
`paragraph 4.2. And you see the heading
`"Peptide/protein/nucleic acid delivery"?
` A. Yes.
` Q. In the second paragraph under that
`heading, second sentence reads, "There are more than
`a dozen depot formulations that are administered by
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`parenteral routes."
` And first of all, today, when we talk
`about the term "depot," do you use that
`interchangeably with "long-acting"?
` A. Yes, you can do that.
` Q. So whether you and I say "depot" or
`"long-acting," we're talking about the same thing?
` A. Yes.
` Q. And parenteral is administration by
`injection; is that correct?
` A. Injections, yes.
` Q. And then you list the dozen depot
`formulations that you're referring to.
` Are those all of the approved depot
`formulations that existed as of the time of this
`publication, 2015?
` A. Yes.
` Q. And have there been more approved, since
`2015, of these depot formulations?
` A. Yes.
` Q. And do you know or can you recall what
`those are?
` A. I don't recall exact name, but one of them
`is to deliver buprenorphine.
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` Q. Could you spell that?
` A. Buprenorphine, B-U-P-R-E-N-O-R-P-H-I-N-E.
`This is to treat the opioid addiction.
` Q. Yeah.
` A. I think there are probably three more that
`I recall, but I don't, right now, remember the
`names.
` Q. And do all of these 15 or so approved
`depot formulations for administration by injection
`include PLGA, to your knowledge?
` A. As I mentioned before, all these approved
`product use PLGA.
` Q. Now, is PLGA a specific polymer or is it a
`family of polymers?
` A. PLGA is a umbrella term. It includes
`PLGA, poly(lactide-co-glycolide). And depending on
`the lactide/glycolide ratio, which you less simply
`say "LG ratio," it may have different properties
`such as degradation kinetics, et cetera.
` So you can choose from variety of PLGAs.
`Depending on your objective, you can select based on
`molecular weight, LG ratio, and integral, which is
`either 1 or 2. So probably that's where most
`scientists begin to select a certain type of PLGAs.
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` Q. Now, after listing the dozen depot
`formulations, you and your co-authors state, "The
`fact that there are only a handful of depot
`formulations as compared with thousands of oral
`sustained-release formulations indicates the
`difficulty associated with developing parenteral
`depot formulations."
` Do you see that?
` A. Yes.
` Q. Now, when you're talking about the
`difficulty associated with developing the depot
`formulations, what are you referring to?
` A. The difficulty here is that oral
`formulations, you're talking about maximum 24-hour
`delivery. Sometimes only 12-hour delivery. So
`compared to 12-hour to 24-hour delivery,
`long-acting, ranging from one week to six months, is
`a different world. That's what I'm saying is
`difficult. Compared to making 12-hour or 24-hour
`delivery system, it's relatively difficult.
` Q. And what about it, from the formulator's
`perspective, is the difficulty in achieving that
`longer release?
` A. If you are trained and/or have a lot of
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`experience in making long-acting injectable
`formulation, to him it's much easier. Once I told
`my French colleague, I said that, you know, French
`language is a most difficult language to me. And he
`said, no, it's the easiest language to him. So it
`depend on who has experience or background or
`knowledge. It may be different.
` Q. Now, skipping a sentence or two, you say,
`"Thus, it is urgently required to improve the
`technology of controlling the drug release
`profiles."
` What did you mean by that?
` A. Not only oral, parenteral, transdermal,
`every formulation, to really make it useful, you
`have to control the drug in this profile. And even
`oral controlled-release formulation, you can see the
`initial release can be very high, compared to
`steady-state release. And if you look at Figure 1
`on the next page, you can see that initial release
`is higher than steady-state release.
` For example, this is Nutropin Depot and
`Trelstar.
` THE COURT REPORTER: This is?
` THE WITNESS: Nutropin, N-U-T-R-O-P-I-N,
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` K. Park
` and Trelstar, T-R-E-L-S-T-A-R.
` A. As you can see, the Panel A shows one
`month's delivery system that you can see in the
`beginning, day one or two, the serum concentration
`is around 80, 90 microgram per liter.
` On the other hand, after about a week, you
`can see that the steady-state concentration -- this
`is a log scale, by the way -- is around 1 microgram
`per liter, which mean we're talking about 50 times
`or hundred times higher release in the beginning.
` Panel B also shows that, in the beginning,
`you know, the peak use somewhere between 50 to 80.
`This is again log scale. But after about a few
`weeks, the steady-state release is between .1 and
`1 nanogram per ml.
` So initial release is very high and this
`is what I meant.
`BY MR. O'MALLEY:
` Q. Now I want to skip ahead in the paper, on
`page 6. And you have a heading, "5, Perspective of
`the Future." And in the second paragraph, the first
`sentence reads, "Advances in drug delivery systems
`are the results of numerous trials and errors, i.e.,
`results of an evolutionary process."
`
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` What did you and your co-authors mean by
`that?
` A. Because nobody really knows what
`formulation will be perfect, nobody really can
`design a delivery system to have a perfect PK
`profile that one wants. We just don't know. So all
`we can do is make a formulation and test in vitro
`how the in vitro release profile works and then try
`in human, so whether there's any correlation between
`in vitro release and in vivo pharmacokinetic
`profile. There you can tweak the in vitro
`manufacturing process and then see how you can
`adjust to obtain the PK profile you desire.
` So it is trial and error per instance.
`There's no one theory that tells you how to make it.
` Q. And again, going back to these dozen depot
`formulations that have been approved as of the date
`of this publication, do you know roughly at all how
`many long-acting injectable formulations have made
`it to the clinics but failed to receive FDA
`approval?
` A. I have no information.
` Q. Okay. We can set that aside.
` Now, I know it's confidential and I don't
`
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` K. Park
`want to get into details.
` But you're currently involved in
`developing a long-acting injectable formulation for
`submission to the FDA, correct?
` A. Preparing for submission to FDA, yes.
` Q. And preparing such a submission requires
`an interdisciplinary team, correct?
` A. You mean submitting requires
`interdisciplinary team?
` Q. Well, developing the materials, the
`clinical studies, the formulation reports,
`everything that becomes part of an NDA, that process
`requires an interdisciplinary team, correct?
` A. Well, it depends on what project you are
`in and what kind of background you need. You may
`need the interdisciplinary team. In industry, it's
`usually the case you work with chemists or
`biologists or medical clinicians, et cetera. But in
`my case, I have been working on this for a long
`time, so I know exactly what I need to do and then
`work with veterinarians to do animal study.
` Q. Okay. So your drug is not meant for
`humans?
` A. Oh, no, no. When I say "veterinarian,"
`
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` K. Park
`means they do animal study using my formulation.
`Not designed for animals. It is for humans.
` Q. So you were talking about the sort of
`typical development in industry. And you mentioned
`that that requires, I think you said, formulators,
`clinicians, and I think you might have mentioned
`biologists.
` Did I get that right?
` A. Well, in industry, first of all, marketing
`people may come to you and say, well, this potential
`drug, potential formulation may have a potential to
`make them money. Then they can assemble team of
`scientists to see what we can do. And then they
`find expertise you can make formulation. So they
`make a team of scientists to work on the
`formulation.
` Q. And one of those scientists you mentioned
`was a clinician.
` What would their role typically be in this
`industrial drug development program?
` A. Clinicians are the one who can treat the
`patients, so they are the ones who can handle the
`patient, talk to patients. So in that sense,
`clinicians participate to tell them, you know -- for
`
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`example, if you have a long-acting microparticle,
`particle size can be such-and-such so that we can
`use some needle to inject them. If it's too big, we
`have to have a surgery and may not be useful.
` Q. Do clinicians, in the typical industrial
`drug development product, also have a role in
`selecting the correct dose of the drug for
`development?
` A. I'm not sure whether we can say as a
`general rule. Finding accurate dose requires a
`Phase 1 study to see how much patient can tolerate
`the drug and at what amounts of dose that patient
`showed response. So it's based on clinical study.
` Q. And often the dose is chosen also as a
`result of Phase 2 clinical studies; isn't that true?
` A. Phase 1 is to show safety. So there, you
`can see what's the maximum dose we can deliver to
`patient. And then you go to Phase 2 to see the
`efficacy. So Phase 2 is to see whether the
`formulation has actual efficacy. That's Phase 2
`study.
` Q. And clinicians are obviously involved in
`those efficacy studies, correct?
` A. Well, obviously clinical study is done in
`
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` K. Park
`the clinical hospital setting, so you have to have
`clinicians who can administer.
` Q. Now, switching gears a little bit, has any
`of your own research involved naltrexone?
` A. Yes.
` Q. And can you describe that research?
` A. Because of this recent opioid epidemic, we
`have been developing formulation that can treat
`opioid addicts. So we have been working on
`buprenorphine/naltrexone delivery systems.
` Q. And this would be a long-acting injectable
`including PLGA, of naltrexone?
` A. Yes. In addition, also we need to deliver
`not only long-acting but fast-acting too, because a
`lot of addicts are taking too much opioid and just
`pass. So we need to wake them up.
` Q. And naltrexone, is that involved in waking
`up the addict, as you put it?
` A. No. NARCAN, was already used, does that.
`But that half-life so short, you have to supplement
`to have a longer effective formulation.
` Q. Now, why are you developing this
`naltrexone formulation? Is this with an eye towards
`eventual development and FDA submission?
`
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` K. Park
` A. Why?
` Q. Yeah.
` A. Why do I do that?
` Q. No. What is the purpose? What is the end
`point? Are you looking for FDA-approved drug?
` A. Oh, absolutely. This -- I was part of the
`team that participated in, last year some -- around
`June, at the National Institute of Drug Abuse,
`because of this opioid epidemic problem, they
`assembled about 40 scientists and clinicians to talk
`about what we can do. And many clinicians mentioned
`that naltrexone delivery system works, but we don't
`have many formulations available.
` And also if existing formulations are too
`expensive, addict cannot afford it. Insurance
`company does not pay for it. So one of the urgent
`need is to develop naltrexone formulation cheap
`enough to distribute to wide variety of patients.
` So -- so using my expertise in
`sustained/controlled-release formulations, I was
`asked to develop formulation that can be made cheap
`enough to distribute to all different types of
`abusers or other people who want a treatment.
` Q. And have you developed such a formulation?
`
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` A. I am developing now. That's one of the
`formulation that I will talk to FDA soon.
` Q. Okay. Are you working with a
`pharmaceutical company in connection with that
`project?
` A. I don't know whether this is confidential
`or not.
` Q. Why don't you just say yes or no for the
`moment.
` MR. VAN BUSKIRK: That works. You can do
` a yes or no. I don't want you to reveal
` anything that may be confidential to whoever
` your partner is.
` A. Yes.
`BY MR. O'MALLEY:
` Q. And is there a targeted date for FDA
`submission?
` MR. VAN BUSKIRK: Again, yes or no.
` A. Yes.
`BY MR. O'MALLEY:
` Q. I mean, I would like to know what that
`date is. I don't know why that would be
`confidential, since we really don't know what this
`is.
`
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` MR. VAN BUSKIRK: I'll allow that. I'll
` just caution you. I don't know what your
` arrangement is, but be careful that you don't
` reveal anything that is confidential to whoever
` your partner is, please.
` A. You mean target date to submit to FDA?
`BY MR. O'MALLEY:
` Q. Yes.
` A. This summer.
` Q. Okay. Now, in this matter, the IPR -- you
`understand what "IPR" stands for?
` A. Yes.
` Q. You're taking the position that Alkermes
`'499 patent is invalid, correct?
` A. Yes. Our position is that '499 patent is
`invalid.
` Q. Now, do you see any conflict with the fact
`that you're trying to invalidate this patent
`covering a depot formulation of naltrexone while
`developing your own depot formulation of naltrexone?
` MR. VAN BUSKIRK: Objection as to form.
` A. No, not at all.
`BY MR. O'MALLEY:
` Q. '499 patent is not a hurdle to the
`
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` K. Park
`development of your formulation?
` A. No, not at all, because my formulation is
`not competing with '499 patent at all.
` Q. What do you mean by that?
` A. '499 patent is 28 -- one month's delivery
`formulation. I'm not making one month's
`formulation.
` Q. Is it confidential to tell me what the
`dose of naltrexone is in your formulation?
` A. Right, it is confidential.
` Q. Okay. Now, you realize the claims of the
`'499 patent are not limited to a one-month
`administration?
` A. Can I see the patent?
` Q. Yes. Sure.
` MR. O'MALLEY: So I'm showing Dr. Park
` what's been previously marked as Amneal
` Exhibit 1001, the '499 patent.
`BY MR. O'MALLEY:
` Q. So when you told me, just to put us back
`in context, that you didn't believe there was any
`conflict, you mentioned because you're not trying to
`develop a one-month formulation.
` Did I understand that correct?
`
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` A. Yes. The current Vivitrol is only one
`month's formulation. So if someone tried to make a
`generic product of Vivitrol, they may have been
`interested in making one month's formulation. But
`I'm not interested in making generic product.
` Q. And then again my question was: You see
`the claims aren't at all defined or limited by a
`one-month administration; is that correct?
` MR. VAN BUSKIRK: Objection as to form.
` A. I was not asked to opine on this
`particular aspect, so I don't have an opinion.
`BY MR. O'MALLEY:
` Q. Now, this naltrexone formulation you're
`developing, have you prepared any publications
`regarding that formulation?
` A. My formulation?
` Q. Yes.
` A. Eventually, but not until I file to FDA.
` Q. Okay. And have you otherwise publicly
`disclosed that formulation through, for example,
`posters or abstracts or any other way of making it
`public?
` A. Well, if I did, it would be a public
`disclosure, so I cannot have a patent application.
`
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` Q. Not all scientists are as disciplined as
`you.
` Okay. Now, you were talking about the
`June meeting that you attended.
` National Institute of Drug Abuse, did I
`get that right?
` A. Yes.
` Q. And I think you told me that the
`participants in that meeting said that long-acting
`naltrexone was working well, something to that
`effect.
`
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