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` UNITED STATES PATENT AND TRADEMARK OFFICE
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`ARGENTUM PHARMACEUTICALS LLC, ) Case IPR2017-01053
` ) Patent 8,268,299
` Petitioner, )
` )
` v. )
` )
`ALCON RESEARCH, LTD., )
` )
` Patent Owner, )
`------------------------------)
`
` - - -
` Tuesday, May 8, 2018
` - - -
`
` Deposition of JOHN C. STAINES, JR., PH.D.,
`taken at the offices of Foley & Lardner,
`3000 K St NW, Suite 600, Washington, D.C.,
`beginning at 9:12 a.m., before Nancy J. Martin, a
`Registered Merit Reporter, Certified Shorthand
`Reporter.
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`800-642-1099
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`David Feldman Worldwide
`A Veritext Company
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`www.veritext.com
`
`ALCON 2168
`Argentum Pharm. LLC v. Alcon Research, Ltd.
`Case IPR2017-01053
`
`
` UNITED STATES PATENT AND TRADEMARK OFFICE
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`ARGENTUM PHARMACEUTICALS LLC, ) Case IPR2017-01053
` ) Patent 8,268,299
` Petitioner, )
` )
` v. )
` )
`ALCON RESEARCH, LTD., )
` )
` Patent Owner, )
`------------------------------)
`
` - - -
` Tuesday, May 8, 2018
` - - -
`
` Deposition of JOHN C. STAINES, JR., PH.D.,
`taken at the offices of Foley & Lardner,
`3000 K St NW, Suite 600, Washington, D.C.,
`beginning at 9:12 a.m., before Nancy J. Martin, a
`Registered Merit Reporter, Certified Shorthand
`Reporter.
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`800-642-1099
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`David Feldman Worldwide
`A Veritext Company
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`www.veritext.com
`
`ALCON 2168
`Argentum Pharm. LLC v. Alcon Research, Ltd.
`Case IPR2017-01053
`
`
`
`Page 2
`
`A P P E A R A N C E S :
`
` Representing the Patent Owner
` WILLIAMS & CONNOLLY, LLP
` 725 Twelfth Street N.W.
` Washington, D.C. 20005
` (202) 434-5208
` BY: ALEXANDER S. ZOLAN, ESQ.
` azolan@wc.com
`
` Representing the Petitioner
` FOLEY & LARDNER, LLP
` Washington Harbour
` 3000 K Street, N.W.
` Suite 600
` Washington, D.C. 20007
` (202) 945-6009
` BY: ANDREW R. CHESLOCK, ESQ.
` acheslock@foley.com
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`Page 3
`
` I N D E X
` PAGE
`BY MR. ZOLAN 4
` EXHIBITS PREVIOUSLY MARKED
`NUMBER Description Page
`Exhibit 1001 U.S. Patent 8,268,299, 19 pages 47
`Exhibit 1059 Statista, Percentage of the 38
` Glaucoma Prescription Market in
` the U.S. as of 2015 by Product
` Type, 5 pages
`Exhibit 1060 Independent Research Update, 41
` Nicox, 20 pages
`Exhibit 1061 July 2016 Corporate 41
` Presentation, 21 pages
`Exhibit 1094 Declaration of John C. Staines, 11
` Jr. in Support of Petitioner's
` Reply to Patient Owner's
` Response, 90 pages
`Exhibit 2046 Travatan Z and Other 88
` Prostaglandin Analog Drugs Share
` of New Prescriptions, 1 page
`Exhibit 2051 Travatan Z and Other 80
` Prostaglandin Analog Drugs Share
` of Voice Excluding Retail Value
` of Samples, 1 page
`Exhibit 2052 Travatan Z and Other 80
` Prostaglandin Analog Drugs Share
` of Voice Including Retail Value
` of Samples, 1 page
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` WASHINGTON, D.C., TUESDAY, MAY 8, 2018; 9:12 A.M.
` - - -
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` JOHN C. STAINES, JR.,
` having been first duly sworn,
` was examined and testified as follows:
`
` EXAMINATION
`BY MR. ZOLAN:
` Q. Good morning, Dr. Staines.
` A. Good morning.
` Q. Can you -- excuse me. "Mr. Staines."
` A. Thank you.
` Q. Good morning, Mr. Staines.
` A. Good morning.
` Q. Could you state your name and spell it for
`the record, please.
` A. Sure. John Christopher Staines, Jr. Staines
`is S-t-a-i-n--e-s.
` Q. Have you ever concluded that a product was --
`a pharmaceutical product was commercially successful?
` A. So concluded -- I've concluded it. Not as an
`expert, but I have concluded that they have been, yes.
` Q. So in the Hatch-Waxman context, have you ever
`written an expert report that concluded that a
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`pharmaceutical product was commercial and successful?
` A. No. I haven't written that many expert
`reports, so that -- right. So the ones I've written
`have not concluded that.
` Q. How many expert reports have you written in
`the Hatch-Waxman context?
` A. Four.
` Q. Did you -- in any of those reports, did you
`conclude that the product was not commercially
`successful because it lacked a nexus?
` MR. CHESLOCK: Objection to form.
` THE WITNESS: Let me preface this. One of
`them was a -- it was Hatch-Waxman, but it was in the
`context of a preliminary injunction, and so that
`didn't come up. So the three other ones -- so one of
`them, I think it was both nexus and commercial
`success. I didn't find it was commercial success,
`No. 1.
` No. 2, even if it were a commercial success,
`that there wasn't a nexus to the patents. I think I
`found that in the second one as well. And I can't
`recall the third one.
` Q. You've written other declarations in the IPR
`context; right?
` A. Yes, two others.
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` Q. And in those IPR declarations, did you
`conclude that those two products at issue were
`commercial successes?
` MR. CHESLOCK: Objection to the form.
`Outside the scope.
` THE WITNESS: So I concluded that those two
`were not commercial successes.
`BY MR. ZOLAN:
` Q. So let's take the first one in time. In that
`report you concluded that the pharmaceutical product
`was not a commercial success and lacked nexus; is that
`right?
` A. Yes.
` Q. And in the second one, did you also conclude
`that that pharmaceutical product was not a commercial
`success and also lacked nexus?
` A. Yes.
` Q. So if you were to write a report concluding
`that a pharmaceutical product was a commercial
`success, how would you go about showing that the
`product was a commercial success?
` MR. CHESLOCK: Objection to form.
` THE WITNESS: I would look at net revenues.
`I'd look at -- I'd compare them to relevant
`comparators. And, you know, a lot of it depends on
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`the context of the drug on exactly what I would look
`at, but certainly sales in a relevant market, that's
`kind of the legal criterion. That's what I would look
`at.
`BY MR. ZOLAN:
` Q. You mentioned net revenue. What if net
`revenues aren't available, what would you look to?
` A. It depends. If it's not pharmaceutical -- if
`this is Hatch-Waxman, that's one thing. If it's just
`a general product, I may look at gross revenues if I
`have -- if I think that that is indicative of the
`sales that are actually received.
` Q. So you -- do you exclude the Hatch-Waxman
`context from that previous answer?
` A. I did.
` Q. Why?
` A. Well, I don't mean to, actually. It could be
`that there are situations where gross revenues and net
`revenues are likely to be the same. If that's the
`case, then gross revenues are net revenues. But
`ultimately it's net revenues that matter because
`that's what's received.
` Q. So let's put you in the pharmaceutical
`context, and either a Hatch-Waxman actor or a
`proceeding like this one in an IPR, and there are no
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`gross revenues available. How do you --
` A. No net revenues available?
` Q. Sorry. Yes. Yes. So you're in the
`pharmaceutical context. You're in either a
`Hatch-Waxman or an IPR proceeding. No net revenues
`are available. What do you look to to determine what
`the sales of that product are?
` MR. CHESLOCK: Objection to form.
` THE WITNESS: Again, it depends. It could be
`that you can't use commercial success as an indication
`of nonobviousness because the data aren't there to
`demonstrate it. The product could still be
`nonobvious, but commercial success does not
`demonstrate that.
` And so it could be that if you don't have net
`revenues and gross revenues are not a good proxy for
`net revenues, that you can't -- then there's no proof
`of commercial successes in this scenario of
`nonobviousness. It could, though, be that you could
`look at quantities and infer some things from that.
`It just depends on the situation.
`BY MR. ZOLAN:
` Q. When would gross revenues be relevant in the
`pharmaceutical context?
` A. When they're not different or not much
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`different from net revenues. So, for instance, a
`product that's usually a breakthrough product,
`oftentimes they don't give them any rebates, for
`instance, or have a lot of copayment assistance or
`anything like that. Such a product that's alone and
`has no brand competition, completely different.
` Plavix is often given as an example, at least
`at one time. I don't know about now. That -- that's
`been shown to have a few rebates.
` Q. What about trends of gross sales? Are they
`helpful in determining whether a product -- a
`pharmaceutical product is a commercial success?
` A. If they are not different -- not much
`different than net revenues. However, over time, they
`can change a lot depending on if a generic comes in or
`not. You'd have a huge change in the rebates, for
`instance, and then the wedge between net and gross
`revenues can change dramatically over time.
` So, as a general rule, they would not be a
`good proxy unless you knew that the gross revenues
`were always close to net revenues.
` Q. How do you go about figuring out if gross net
`revenues are close to net revenues? What information
`do you need?
` A. Well, in almost all cases except this one,
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`I've had net revenues. It's been produced or it's in
`the annual reports. In this one, there's no
`information on net revenues for some reason. And so
`this is rare. So what I look to is -- in this case, I
`think in my report I have some things, I'll probably
`miss a few, but there are certain indications that
`when you have, for instance, products that -- in a
`therapeutic class -- brand products in a therapeutic
`class that are based on different chemical entities
`but nonetheless are not highly differentiated in terms
`of efficacy and those kinds of things, that typically
`you have higher rebates for those.
` I think there's an indication -- I might have
`cited an article from an ophthalmology magazine where
`they're talking about the -- they notice there are a
`lot of rebates on Travatan Z and Lumigan.
` What else? I think I have one or two other
`reasons in there that -- in this case why I would
`expect a pretty big difference.
` Q. Sure. I didn't mean to keep you from looking
`at your report.
` I've just handed the witness a copy of
`Exhibit 1094.
` Can you confirm that that is a copy of the
`declaration you prepared in this case?
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` (Previously marked Exhibit 1094 was handed
` to the witness.)
` THE WITNESS: Yes. That looks like it.
`BY MR. ZOLAN:
` Q. I think you make the point in there and you
`cite some literature in support of the point that
`sales, gross sales, net sales, sales generally are
`relative depending on other attributes of the market.
`Is that fair?
` MR. CHESLOCK: Objection to form.
` THE WITNESS: They have to be compared to
`something. When you talk about significant sales,
`"significant" is a relative term, and so it has to be
`put into context.
`BY MR. ZOLAN:
` Q. So if you didn't have net sales information
`but you did have gross sales information and you
`compared the gross sales of one product in a
`particular market to the gross sales of other products
`in that particular market, that would be some evidence
`for or against the commercial success of that product;
`is that right?
` MR. CHESLOCK: Objection to form.
` THE WITNESS: As a general matter, it could
`be.
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`BY MR. ZOLAN:
` Q. And if you don't have any information at all,
`no dollar sales information, you could look to the
`number of prescriptions dispensed or written; right?
` A. Look to it for?
` Q. To determine -- to determine -- you could
`look to it -- strike that.
` One of the factors you could evaluate, when
`analyzing whether a pharmaceutical product is a
`commercial success, is the number of prescriptions
`dispensed. Is that fair?
` A. That can be a factor, yes.
` Q. And it's more helpful if -- to the analysis
`if the number of prescriptions dispensed is in context
`as compared to other products in the relevant market.
`Is that fair?
` MR. CHESLOCK: Objection to form.
` THE WITNESS: It can be an indication -- it
`could be a factor that suggests, if it's high, that
`somebody -- another developer would have had an
`incentive to have developed a product. But
`ultimately -- and I think I mentioned in the report --
`only insomuch as it indicates what the net revenues
`are. Because it's net revenues ultimately that's
`going to incentivize somebody else to develop the
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`Page 13
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`product.
` So if it suggests that net revenues are high
`enough to have attracted entry by somebody else, if
`the technology is that obvious, then it would be
`probative.
`BY MR. ZOLAN:
` Q. I think you make the point in your report
`that that's ultimately what the commercial success
`inquiry is about in your understanding, whether or not
`a competitor has an incentive to enter the market; is
`that right?
` A. Yes. That would have been developed. If it
`had been obvious, somebody else would have already
`developed it and made that money. So we wouldn't have
`made the money here; Alcon wouldn't have.
` Q. What about growth trends in the number of
`prescriptions dispensed over time? Is that a useful
`factor in doing the analysis for a pharmaceutical
`product about whether it's commercially successful?
` A. As always, it depends. So in and of itself,
`a growth rate doesn't say anything because it depends
`on -- that's relative. It depends on where you start.
`And if you start when something has zero, you kind of
`have an infinite growth rate no matter what time
`period you're looking over. So it depends on the
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`context.
` So, for instance, in this case, I looked at
`Travatan before the original Travatan, before
`Travatan Z, and saw that that growth rate was
`increasing -- that was an increasing growth rate. So
`there I could make an inference that very likely it
`would have continued increasing. I don't know at the
`same rate, maybe a little less, but ultimately it
`would have been pretty close to what Travatan Z got.
` So in that sense, I think a growth rate is
`useful. That's an example. I'm sure there are other
`contexts in which it can be useful, but there are
`other contexts where it's irrelevant.
`BY MR. ZOLAN:
` Q. The same question that I asked with the
`number of prescriptions dispensed to -- sorry -- the
`number of sale or the quantity of sales which is --
`it's additional information that's potentially useful
`in doing this analysis to determine how the growth
`rate and the number of prescriptions dispensed
`compares to other competitors in the relevant market.
`Is that fair?
` MR. CHESLOCK: Objection to form.
` THE WITNESS: Let me say, first of all, in
`the example I gave, I was talking about units. There
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`Page 15
`are probably prescriptions, too, but we don't have the
`data going back before then. When you say "compared
`to other products," sometimes it's useful; sometimes
`it's not. It depends again. If you define the
`market -- if you have a very small market and you have
`100 percent of that market but the sales are, you
`know, $2,000 in that market, then that's not very
`useful information.
` But if it's suggestive of a lot of dollar
`sales such that somebody would be motivated to have
`developed the product -- developed the technology and
`marketed it, then it would be useful information.
`BY MR. ZOLAN:
` Q. So I think the phrase you used was
`"significant sales in the relevant market." Is --
`what you're trying to analyze in determining whether a
`product is commercially successful; is that right?
` A. That's right. That's the legal criterion,
`right.
` Q. What does "significant" mean?
` A. So, again, that's relative. And you look at
`a lot of things together, but ultimately to understand
`what significant -- if it's significant or not, if it
`has to be compared to something. Ultimately, though,
`it has to be significant enough to have motivated
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`A Veritext Company
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`www.veritext.com
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`Page 16
`somebody else to have developed the product and
`marketed it before, had the technology been obvious.
` Q. Who are you looking at when you say that a
`competitor would have had the incentive to make it or
`not to make it -- to make the product or not make the
`product?
` I forget if I have a cite in here or not, but
`I think there's an article by Mark Lemle, L-e-m-l-e.
`There's another thing in -- by the ABA. There's an
`article in the ABA magazine, I forget the name of it
`-- Landslide -- where they talk about that. That's
`the ultimate question. I think in Merck vs. Teva
`there is -- that decision -- I think there was a CAFC
`decision where they indicated that others would have
`developed the product had it been obvious. That's the
`criterion that might -- the ultimate criterion.
` So that's what I can remember, but it's just
`kind of over time I picked that up. And then lawyers
`like these guys have also told me that (indicating).
` Q. I guess what I'm trying to understand,
`though, is when you say others would have developed
`it, who are the others you're looking at? Is it
`hypothetical people? Are they actual entities? Who
`are you looking at to determine whether somebody would
`have had that incentive?
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`www.veritext.com
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`Page 17
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` MR. CHESLOCK: Objection to form.
` THE WITNESS: So, for instance, Merck vs.
`Teva says the market would have developed it. The
`market would have had incentive to develop this
`product earlier if it had been obvious. They don't
`necessary talk about a specific person. So I'm
`thinking of anybody in the market. I mean I don't
`know the POSA, or whatever you guys call that. I
`don't know how that enters in or not. Maybe that's
`what we're looking at.
` But ultimately it's a pharmaceutical company.
`It's somebody who could make money on this technology
`if it had been obvious that they would have done so.
`So that's what I'm looking at.
`BY MR. ZOLAN:
` Q. So you would look to see whether the other
`pharmaceutical companies in the relevant market would
`have had incentive to invent what is claimed in the
`relevant invention?
` Is that what you're saying?
` MR. CHESLOCK: Objection to form.
` THE WITNESS: No. By no means do they have
`to be in the relevant market, whatever that is, but
`somebody who is competent to develop something like
`this -- like this product and -- and market it, that's
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`the market. I mean that's the people who could come
`up with such a thing. But ultimately it's the market.
`It's not a personal thing.
`BY MR. ZOLAN:
` Q. Earlier when I was asking about the various
`factors that are useful to look at, I think as a proxy
`for net sales --
` A. Uh-huh.
` Q. -- I mentioned gross sales. I mentioned the
`number of prescriptions. Do you remember that?
` A. I do.
` Q. And I think -- if I might summarize what you
`said -- you said that for a number of prescriptions
`dispensed, that could be useful. You've got to look
`at the context and, ultimately, it's about whether or
`not they produce net revenue. Is that fair?
` MR. CHESLOCK: Objection to form.
` THE WITNESS: Pretty close. If they imply
`something about net revenue, that that net revenue
`would have been sufficient to have attracted somebody
`else to develop the product.
`BY MR. ZOLAN:
` Q. And the same is true looking at gross sales.
`Could be interesting. You've got to look at the
`context and, ultimately, it's about whether or not
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`they are a good proxy for net revenue. Is that fair?
` A. Yes, I think that's fair.
` Q. And is the same thing true with number of
`units that are sold?
` A. Yeah. Units and prescriptions I kind of look
`at the same. It's a quantity measurement.
` Q. What's the relevant market here in this case?
` A. I haven't come up with an opinion on it on
`what the relevant market is. Dr. Grabowski seems to
`suggest, or maybe actually explicitly says, the market
`is PGAs, and he's a little vague on whether Rescula is
`a part of that or not. There might have been one
`other brand that he kind of included when he looked at
`the market. I think he looked at that as market
`shares.
` I have a little -- I was going to say a
`little footnote. I have a long footnote somewhere
`that talks about, you know, that I have seen allusions
`to these beta blockers and some other things that are
`-- like we used before the PGAs, and that still appear
`to be used at least with like half the market -- half
`the market -- half of prescriptions for IOP, glaucoma,
`that half of them are these non-PGA products.
` So it kind of raised a question to me on
`should these be included in the market, but I haven't
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`done analysis to determine whether they should be or
`not. I just raised the question.
` Q. And so you -- strike that.
` I take it you have not done that analysis
`here. Have you also not done the analysis to
`determine whether your opinions would be any different
`if Dr. Grabowski had defined the relevant market as
`the glaucoma market as opposed to the market for
`prostaglandin analogs?
` A. My opinion wouldn't have been different. I
`think his might have been different. But for my
`opinion it's irrelevant because it ultimately comes
`back to the issue of the substitution as a successor
`product. And so that doesn't -- to me, that's -- how
`you define the relevant market doesn't impact that
`conclusion.
` Q. You make the point that you think his opinion
`might be different because of -- it's Footnote 33,
`Page 16 of your expert declaration.
` A. Uh-huh.
` Q. And the sentence that carries over from
`Page 16 to 17 is what I'm looking at.
` A. Yeah.
` Q. And I think, you know -- I'll read it.
` "To the extent these non-PGA products are
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`reasonably substitutable with PGAs, including them in
`Dr. Grabowski's share calculations would be expected
`to reduce his Travatan Z quantity shares by merely
`one-third."
` Is that right? Did I read that right?
` A. Yes, you read it correctly.
` Q. Is that the reason you have identified for
`why Dr. Grabowski's opinion may be different if the
`relevant market was defined as the glaucoma market as
`opposed to the prostaglandin analogue market?
` A. Yes.
` Q. But we can agree that a share is a proportion
`of a market; right?
` A. I think that's a fair characterization, yes.
` Q. So when you make the point that his share
`calculations would be expected to reduce his
`Travatan Z quantity shares by nearly one-third, all of
`the quantity shares of the various products in the
`market would similarly be reduced by one-third; is
`that right?
` A. Yes. Well, let me rephrase. No, not quite.
`Almost. The PGAs would be, but the non-PGAs would go
`from zero to whatever they are. You know, they would
`get shares. Right now they have no shares. So in
`some sense, still Travatan Z would have -- would be a
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`smaller proportion of the market. So where he might
`-- Dr. Grabowski might see 40 percent, and I'm at a
`third, whatever that turns out to be, it's a
`30 percent share. That's somewhat less significant.
` Maybe it affects his opinion, maybe not. But
`still, it implies that it's less important in some
`sense the way he seems to be looking at it.
` Q. But it's possible to conclude that the --
`strike that.
` The proportion of a relevant market -- the
`share, let's say, of a relevant market that might show
`commercial success is influenced by the number of
`other participants in that market. Is that fair?
` A. If it is, then the share doesn't tell you
`much. It means you shouldn't be looking at share.
`Okay. And that's where I kind of come out, is that
`the share may be a proxy to tell you that the net
`revenues are going to be high enough to attract an
`investment into the technology if it had been obvious.
` But if your share is affected by how -- you
`know, who you have in the market and it's ambiguous
`who should be in the market, then the share has less
`value and indicating that the sales are significant in
`the sense I've defined "significant."
` Q. Let's look at the -- let's think about the
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`glaucoma market from 2001 through 2017. Was it a
`competitive market?
` MR. CHESLOCK: Objection to form.
` THE WITNESS: As an economist, you know I'm
`going to say there are gradations of "competitive."
`There's no such thing as a perfectly competitive
`market.
` Is it competitive? I just -- I would say
`it's not perfectly competitive. Outside of that, you
`know, I -- it's -- there's some elements of
`competition and there's some elements of market power.
`BY MR. ZOLAN:
` Q. Okay. What are the elements of competition
`that you see in the glaucoma market?
` A. I see competition in marketing between the
`different brand products. I see competition among the
`generics with each other in price. Competition
`between the generics and the brands. You know, over
`time, the PGAs have been competitive against the beta
`blockers, the non-PGAs before then. And so they've
`taken share away from them.
` Again, if it's the glaucoma market, the wider
`market, then that's in competition, too. So there's
`the elements of competition. Market power is --
`basically it keeps the prices above marginal cost.
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`So there's market power by definition because -- and
`then there are entry barriers. And so there's
`indications of market power.
` Q. How can you tell what the marginal costs are
`in the glaucoma market based on what you've reviewed
`for this case?
` A. Yeah. In this case, obviously, we don't have
`any information on the costs. In general, brand
`products, the marginal costs are very low, marginal
`costs being the cost to produce one more unit, because
`the operating profits have to recover -- hopefully
`recover the R&D investment and also recover the market
`expense, which may not be -- some of that might be
`marginal, but most of that is not in the stock of
`marketing.
` Q. Looking now at the prostaglandin analogue
`market, as Dr. Grabowski has defined it, there are
`multiple companies manufacturing pharmaceutical
`products in that market; right?
` A. Yes.
` Q. There are multiple branded pharmaceutical
`companies marketing and producing pharmaceutical
`products in that market too; right?
` A. Yes.
` Q. And at this point, or at least from 2011
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`Page 25
`forward, there were generic companies that were also
`producing manufacturing pharmaceutical products in
`that market; right?
` A. That's correct.
` Q. When a pharmaceutical product launches, is it
`usually accompanied by a pretty significant
`promotional spend?
` MR. CHESLOCK: Objection to form.
` THE WITNESS: "Significant" is relative but,
`yes, significant to its own sales, generally, yes.
`BY MR. ZOLAN:
` Q. And -- all right. How does that promotional
`spend change over time, if at all?
` A. Again, I don't think that's relevant in this
`case, but in general -- as a general matter, when you
`introduce the product, usually the expenses are high.
`I think Dr. Grabowski, in one of his articles,
`indicated that it might be 100 percent of sales in the
`first year. Then diminish to 50 percent and then down
`to 25 percent. So that might be a reasonable
`estimate. My general experience is that over time,
`promotion does get lower after the first year or two.
` Q. What about the number of prescriptions?
`Let's say that you have a -- let's assume you have a
`commercially successful product. Are there any
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`Page 26
`generalities about how the number of prescriptions
`changes over time?
` MR. CHESLOCK: Objection to form.
` THE WITNESS: So prescriptions or unit sales
`go together, and for the typical product you have a
`life cycle and usually you have increases at the
`beginning because you're starting from zero. So
`you're going to increase. At a certain point, you'll
`hit saturation. You might hit a maturity phase and
`then a decline phase. The decline phase to be
`influenced by generic entry or entry of other products
`like in the case of PGAs versus the non-PGAs, beta
`blockers and stuff. That diminishes sales and so you
`enter into a decline phase.
`BY MR. ZOLAN:
` Q. Can you tell ex-ante when that product is
`going to enter its -- you called it -- you called them
`maybe saturation or mature phase?
` A. So your question is can you --
` Q. Can you predict? Let me ask the question
`again.
` Is it possible to predict ex-ante when --
`let's assume a commercially successful pharmaceutical
`product is going to hit its saturation or mature
`phase?
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`
` MR. CHESLOCK: Objection to form.
` THE WITNESS: It's impossible to predict that
`accurately. People can make estimates and maybe
`forecast, basically. So you can forecast it, and
`you're either right or wrong. You might be close or
`you might be way off.
`BY MR. ZOLAN:
` Q. Now, in the last question I had
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