Pharmascience Inc. v. Meda AB et al - Nov 19, 2021 - Part 1
2:11PM Nov 19, 2021
MR. de SOUSA
Good morning. Can you hear me well? Very well. Okay excellent. I can hear you. Well, I can see you on. So. Okay, so my understand you'll actually be the second witness call today. Okay. So,
excuse me, Justin, we've come to an agreement. We're not going to be calling the first witness and I will speak I will speak to that when started or when a card opens, okay, so Dr. Hollis will be the first witness.
That's perfect. And that case, Dr. Hollis. I will for the time being output shoe in a waiting room. That's all right. And did you have any questions or any concerns about how this will work? For me?
No, that seems fine. Okay, perfect.
Thank you. Very much. Ready? To resume?
I am Yes.
We are here and ready as well. Mr. D'Souza thinking. recording in progress.
Thank you. Good morning, counsel. Morning. Are we ready? Yes, I believe so. Justice. As a preliminary matter, the parties have come to an agreement such that we don't need to call Mr. Venice pants off today. And that agreement involves marking two documents as trial exhibits. That's what was the purpose for this testimony. Okay, we've agreed that FC 260 which is IMS data can be marked exhibit. have also agreed that this document contains the iqvia which is the new name for IMS, C D and H data C G and H extended units and dollar sales for SNF as often as finasteride and mantiene for the period from January 2009 to December 2015 and may be admitted into evidence. Sorry, my phone is going off. I forgot to silence it. That will be exhibit 123. Let me just take a minute. That's right. That's fine. That's just my phone sorry about that, thank you. Not at all. And the second document is FC 261. And the agreement is again that this contains the API C D and H extended units and dollar sales for finasteride for the period from January 2001. To October 2015 and may be admitted into evidence. It'll be exhibit 120 for them. And as I understand it, the defendants have a qualification they may wish to add which is Notwithstanding these documents being admitted into evidence that they maintain their objection as to their relevance to any issue in this proceeding.
Precisely. Thank you, Mr.
stains. Thank you. And so with that justice in, we're prepared. We're ready to go ahead with Dr. Hollis.
Well, yeah, and one one more update for the court. This looming terrifying readings motion we've decided not to not to pursue the additional related readings that my friends didn't put into the trial exhibit. We mark that first day so you're not going to get a motion on that from us. And there are some issues still remaining with respect to the readings that we had proposed. Once the plaintiff closes its case and we have a chance to look at those over the weekend. Hopefully we can reach an agreement and you'll not have any readings of motions at all. Stop at no readings so don't get too excited. But no readings emotions, with any luck. So just wanted to note that as well.
Thank you very much, and work hard on that agreement.
Well, it's easy when it doesn't matter very much. So let's see it didn't with respect to what we were still you know worried about what there's I'm pretty confident we can sort the rest of it out.
Okay, well Dr. Hollis is in the waiting room. Hello Dr. Hollins.
Good morning, sir.
Um, are you doing well, Carlos?
Yes. Thank you.
Excellent. Are you ready to be sworn in?
I have it noted here that he has chosen to make a solemn affirmation. Is that correct? That's correct. Okay. In that case, I'll ask you to please state your name, occupation and professional address, please.
It's Aiden Hollis. I'm an economist. And a professor of economics at the University of Calgary and my professional address is 31 100 Conrad drive northwest Calgary, Alberta.
Case. You solemnly affirm that the evidence to be given by you to the court shall be the truth, the whole truth and nothing but the truth? Please say I do. I do. Q And I'd also add that just a reminder, we asked all parties to speak slowly and clearly and into the direction of their microphones, please to avoid any background noise and to facilitate transcription.
I'll do my best. Let's just gains me. Thank you justice. And good morning Dr. Hollis.
Are you alone in the room and without any documents in front of you beyond your reports? Yes. Can you please briefly describe for the court your educational background
and bachelor's degree in English Literature at the University of Cambridge. They turn that into an MA after several years because they do. And later I attended the University of Toronto obtained a master's degree in economics and immediately after that a PhD degree in economics focusing on the subject area of industrial organization.
And after you completed your PhD, what did you do sir?
I immediately was hired by the University of Calgary to teach in the economics department.
And I understand you're still teaching there I am. And do you hold any other appointments beyond your professors professorship?
I'm also Tilly, a associate professor at the University of Toronto and the Faculty of Pharmacy. This is to enable me to participate in supervising a student, a PhD student there. And I'm also the president of a US based NGO called incentives for global health.
And what's the mandate of that organization?
It's to advance a method to support the development of neglect drugs for neglected diseases and access to those medicines in low income countries.
Doctor hospital What is your academic work focus on?
For the last 2025 years it's been mainly focused on pharmaceutical markets so innovation and competition in pharmaceutical markets.
And I understand that your research has been published from time to time.
Yes, I have now a longer CV than I imagined I would have before
with. I think it's
peer reviewed publications and two books.
And can you please provide the court with some information about the research you've done that's particularly relevant to the matters before the court?
Certainly. So, first I refer to an article published in 2002 in the journal health economics, which I'm trying to remember the title
at the importance of being first
that's the one relating to the the effect of entry order on the market shares captured by generic firms.
And you've included in that in your report is H dash two dash H V and it's SC 37. Just so the court has it and I understand you updated the this analysis or work in in a paper in 2015.
That's right in work with my graduate students and also with Dr. Paul Groot endorsed. We took more recent data that was also somewhat more fine grained. To look at the potential reasons for why it is that entry order might be so determinative of generic market share.
And this is the paper entitled Newton's first law as applied to pharmacies why order enter entry order matters for generics? That's right. And Justice zoom this is attached as shedule H dash three dash ij EB and is uploaded as FC 38. And I understand Dr. Hollis you do not have access to the data that was used in preparing that paper. That's right. What can you tell us about that you recollect about that data.
So it was IMS data that was provided by the cgpa at the time the associate the Industry Association for the generic companies, which we asked for specifically in order to do this research and it was provided under licensed by from IMS.
And what was the nature of that data?
The data was basically the sales of drugs both branded and generic in large number of markets in Canada from the late 1990s till around 2010 or something like that. I could find that exactly if you'd like no quarterly data on sales.
And did you do you have other experience with the pharmaceutical industry?
Yes, since I've been working in this field for 20 years, I do want to ask me something more specific.
have you consulted to others in the in the pharmaceutical industry?
Yes, I've been both an expert witness and in earlier years not not recently I've also provided consulting services. Being an expert witness now in numerous section eight cases like this one.
And I understand you've executed a certificate confirming your agreement to be bound by the code of conduct for expert witnesses. Can you tell the court your understanding of your role here today?
My understanding is to the court my expertise on what I think the Well essentially in a way that's responsive to my mandate.
Now if you could just turn to your first report, I forgot to put that up at paragraph 13. Can you describe the court describe what you're saying here? ask my colleague to bring that up on the screen does this paragraph describe your understanding of your responsibilities as an expert witness? Yes. And just turning down to 14 and 15. What are you saying here
that I recognize in paragraph 14 that although I've been retained by pharma science in the past
that that shouldn't affect and nor does it affect my ability to provide impartial assistance to the court and in 15 that from my own personal perspective, I have no interest whatsoever in the outcome of the litigation. So whoever wins or loses or earns one more dollar out of the my testimony. I certainly don't get any benefit from that.
And have you been retained by brand companies in the past to provide expert opinions?
Yes, I have.
And I understand Dr. Hollis that you've been previously qualified. As an economist within expertise and industrial organization and the markets for
farmers. Yes, and justice and that's exactly the qualification we would ask that this Court accept and it's been agreed to by my friends.
So if we could ask that he Dr. Hollis be qualified in that manner and be permitted to give opinion evidence within the air His areas of expertise. He's qualified, exactly as you stated. Thank you and I understand Dr. Hollis. You've prepared three reports in this case when dated July 7 2021, which was revised in a report date is August 2018 2021. And a reply report, which is familiar to the court by now dated October 11 2021, which has been somewhat altered through the course of court proceedings. Is that right? Those are your three reports. Yes. And Justice Xin. I would ask that we mark these as trial exhibits can they be taken as read? The first is the July 7 2021 report. Which has FC numbers 35 through 44. And that will be exhibit 125 And then staples read. Thank you and the second report is dated August 1820 21. And that's FC 47 through 52. Escaping news read and is exhibit 126. And finally, the reply redacted as for the court's order, dated October 11 2021, and that's FC 53 to 57. Also takings readings. Exhibit 127. Can you briefly explain for the court Dr. Hollis why you were asked to prepare the August report?
Certainly, do you mind if I just open up the my first report so that I have that in front of me not at all?
So in quick summary The goal of this report was to assess the likely damages to Farmer signs from its having been excluded from the market over a period of approximately two years.
So you're talking about your first report I was asking you about the second report but we can get to that
So yeah, that if we could put Dr. Hollis his first report up on the screen at paragraphs 11 Dash 12.
This describes your mandate in that report. Is that what you're referring to in your answers? I understand that you. Your putt is a four part approach. Could you briefly describe that for the for the court?
Certainly this is something that has become standard in these cases. So for first part is to estimate the counterfactual total sales of in this case zolpidem. That is to say the size of the entire market, including brand engineering sales, and then second, to estimate the likely generic share of those sales or to the share of sales share of generic sales that would have been captured by pharma science. And fourth, to make any additional adjustments that are needed, in particular, reflecting type.
Thank you. Now just flipping ahead to paragraph, Page seven paragraphs 25 through 28. You identify the key assumptions that you made you accepted in coming to your opinion in this case.
Tell us what those sorry, go ahead.
Good that the key assumptions being that in the hypothetical scenario Pharmascience would have been able to enter in early January 2015. Apotex would have followed it in mid February 2015. And then the delay period comes to an end on December the seventh 2016 not quite two years later. So those are the key assumptions here.
And I understand that in your second report you were asked to add an additional assumption
that's relating to the timing of the formulary listings are all formulary interchangeability.
Yes, that's it.
Yes, concerning the basically the explicit dates at which of formulating changes interchangeability, but have been given those dates I didn't have in the first report but corrected for them in my secondary
ahead to paragraph 33. Dr. Hollis your first report. This is where you discuss the total size of the zolpidem market can you drive for the court? Where you and Dr. Bruce Gruden DARS Darst are in respect of this issue.
So we're in agreement on this issue. The expected size of the market given that in the real world Apotex entered in February 2015. And in the hypothetical world Pharmascience would have entered just over a month earlier, the expected total size of the market remains unchanged, compared to the hypothetical compared to the real world.
Turning to your analysis of stage two, which begins in paragraph 38. Can you explain how you determine the generic share of this total market?
Certainly, for the generic share again, I expect that the actual generic share of the market starting in February is an appropriate model for what would have happened in the hypothetical world. So in the real world, there was only one generic in the hypothetical scenario with two generics. I anticipate still the same generic share of the market. And so I simply advance the generic share by a month in effect,
and I understand you considered this further in your second report where you looked at the nation. That's right. And I had
so in my second report, so I was advised after I submitted this report that the RFI dates might have meaningfully changed relative to the scenario which Apotex faced, in particular that pharma science would not have had the same rapid advance to off formulary interchangeability. As Apotex benefited from in effect, that would have meant that in Ontario and this is particularly what is relevant in Ontario, that would have been essentially a delay of one month relative to the real world situation. It would have been a delay of a month during which a farmer science would not have benefited from an off formulary interchangeability designation. The result of that is that I had to make an adjustment to account for that delay. It's a little bit tricky to do so in the real world. In Ontario Apotex almost immediately obtained a an off formulary interchangeability designation. And so when we look at and what happens is they almost immediately go to a relatively high share of the market in Ontario. But it's hard to know whether this is causing interest or whether it's entry with the CFI following rapidly thereafter. So in order to determine what would likely have happened in the absence of an LSI designation for pharma science, and I looked at other markets in which an RFI designation was important and those are mantiene and finasteride. In those markets, I'm able to trace what happened in Ontario and in other provinces. When there's no fi designation, and then what happens when the O fi designation is given an Ontario so what I do in my corrections report in August, the second report is to actually look and see how much Ontario's how much the generic share increased in Ontario in those two other markets, relative to how much it increased in several other Canadian provinces, where RFI designation was not given. And so I'm able to basically track two trends over time. That is to say, how much the market share was increasing in Ontario and then how much it increased in other provinces as well during the same period and I'm able to identify that the average across the two other markets. The OSI designation appears to have fairly immediately boosted the market share of the generic product or generic products by around 36% And there are two different estimates. I think one's 24 and one's 48 for the two different products. So I take the average the result of doing this is so so the implication of having done this is I'm able to say that in Ontario, given that there's basically a one month delay in the OSI designation for them. I should assume that instead of the rapid increase in market share that Apotex actually saw, I should deduct for a month 36% The estimated effect of RFI interchange the RFI designation from the generic market share
and I understand this led to a an opinion that there was a reduction of far usciences sales in the bipolar world for that month.
That's correct, actually, just the generic market share overall.
You also looked at the impacts of the formulary or the off formulary designation. In Pei and Nova Scotia. Could you just briefly tell them Mr. Justice and what you saw there?
Certainly in PEI, I wasn't able to see any effect. Maybe it's worth pointing out that in the data that we're using Pei and Newfoundland are aggregated. The OSI designation applied as I understand it only to Prince Edward Island. Nevertheless, Prince Edward Island is big enough that if there were a meaningful effect of the FAI designation, one should have expected to see it. I didn't see anything so I didn't do anything about that. For Ontario, I had to treat it a little bit differently again, and in this case, what happened in the real world was that in the real world in Nova Scotia after a generic entry, there was a several months of delay until an RFI designation. And then in July of 2015, this was granted and immediately, the generic market share increased rapidly. So in the hypothetical scenario that I've been asked to model, metaphor happened in February 2015. So I apply exactly the same increase in generic market share, effectively advancing the generic market share from July to February for the case of Nova Scotia
I understand Dr. Hollis that you disagree with Dr. Grusin route and are adopted. indicated. When you explain this.
Yes, it turns out not to be very material, but Dr. Gruden doors to use as a when he is trying to estimate the effect of the RFI designation in Ontario. For zolpidem. He's simply looks at other provinces, and then compares the market share and those other provinces with market share in Ontario. And this, he claims that he can identify what is the OVI effect in Ontario. I don't think that's appropriate on the basis that in Ontario. It was really difficult for pharmacists, as I understand it to to substitute from the brand a prescription written for the brand to the generic until an MFI designation is given or in the case of a product which is actually listed on every listing in contrast in other provinces such as Alberta and BC, pharmacists are given professional authority to substitute according to their professional discretion and knowledge.
So just as in I'm having trouble finding this in any of Dr. Hall says reports that have been made up trial exhibit perhaps my friend can assist me with paragraphs that he was taking Dr. Hollis to
Yes, please. Why don't we just move on then?
Well, that I have then I have an objection to the question and the and the answer. I if it's not in the report, and my friend can point me to where it is or more importantly, I suppose just as soon you do where it is in the reports, then I think he then then I object to the question and the answer being in there.
Okay. Let me let me be clear in justice in in your order. With respect to Dr. Gruden Dr. Hollis his reply report. You did say several instances that that he would be entitled to testify to his disagreements with Dr. Gruden Dorst. You actually said that and that's what he's doing. I did say that. And that's exactly provided. That's all he's doing. That's all he's doing. That's all allow that. Thank you.
Well, then then I have an additional objection. With respect to the evidence with regards to hearsay because in in the portion of the reply report that was not permitted, where Dr. Hollis is addressing this issue, he advises that he was advised about these things by counsel who got them from Ms. Bukowski. So if we were going to hear about the differences in formulary, interchangeability and, and pharmacists obligations, etc. I respectfully suggest it ought to have been from the kowski and soul, which is then triple hearsay and opinions or opinions. I understand that in, in those paragraphs of the reply report that were not admitted. That was the source of some of this evidence, which in my respectful submission wouldn't have been admissible not just because it's not proper reply, but wouldn't have been admissible in the first place.
I think in the past, he did testify to exactly the same as yesterday. And justice, then if I might add that, not talking about what Mr. Makovski was talking about, it's talking about the distinctions and disagreements between Dr. Hollister and Dr. Gruden Dyson. With all due respect, I believe it'll assist the Court to hear this. As I said before, I'm prepared to hear this witness explained to me in his opinion, and Dr. Dorsey obviously why he thinks this is better. Thank you. If we can get back on track then Dr. Hollis. You're talking about the comparison of provinces and the market dynamics in those provinces. Is there anything further you want to add here?
Simply that the because the provinces are quite different trying to date a different evolution of generic market share across the provinces. And it's not clear that there is as Dr. Gruden doors such a, I think a pure generic entry effect versus a an O MFI effect now Alberta and BC for example, as I know very well without reference to any other expert Moreover, and so trying to assert that there's a an A pure fi effect to me doesn't really make make good sense. In this context, what should be happening under those circumstances is that you're going to be combining essentially a variety of effects.
Turning to stage three, Dr. Hollis, I understand that your analysis in this portion draws at least in part on the paper. Excuse me, on which you and Dr. Bruce get endorsed and another were named authors. That's right. And this is the IJ EB paper that we referred to earlier.
I'm just okay. So as I as I look up, I'm I have another screen. So I'm, I'm looking at my report, but just so that we're on the same page.
Good. Can you explain how you think in offices are part referring in particular now to page nine, paragraph 44 of your first report?
Yes. So I think it just for the convenience of everyone on the court. I'm going to refer to this repeatedly as the iGEM but paper. So for the court reporter ij Ed. In this report, as I mentioned, what we did was to attempt to understand the cause of the effect that the first generic and generally entry order has on market share in the Canadian generic market market. And essentially, what we do is a regression analysis. I think it's 33 markets but I'm not quite sure of the number in which we basically analyze, what are the how much impact mg order has on generic market share, lift that is how much it matters, when exactly you enter relative to the first generic how much it matters if you were the sole first generic for a long period of time. How many generic competitors there are in the market, all of those things. Basically, you're holding on to a regression and then they're used. They're related to the generic market share of each firm. And from that, we estimate the effects of each of those features of the market are actually entry timing on the expected generic market share of each firm.
And how did you determine pharma sciences share the generic market in stage three of your analysis?
So in stage three, I use essentially two methods and then average those so I'll first first of all to my first method. I'll call that method one. So in method one, the approach that I use is to look at Apotex as actual share of the generic market in this open end market. Following pharma sciences entry. And I essentially do this because I'm thinking that in the hypothetical world farm designs would have been first Apotex second, and so their positions are relatively speaking reverse. However, I can't just do that. I know from the iGEM paper that in
practice, these tend to have
a larger share of the markets which they enter. So if you have lots of sales and other markets, you're likely to be successful in any other market that you enter as well. And we estimated the effect from our paper and found that basically, there's a sort of an estimated 12% Extra market share for every billion dollars in sales that you make. So if in other markets, you were making an extra $12 billion in sales compared to a was making $12 billion more in sales than from B, then they both enter a market. The larger firm is going to get an extra 12% market share compared to the smaller firm. So we made I use this adjustments, adjusting for the actual sizes of Apotex and pharma science as best I could. And that yield so rough roughly a 9% OR 10 or nine or 10%, like remembering the change in the market shares attributable to pharma science compared to Apotex. So, there's a second thing which is the in the real world Apotex entered almost two years before farmer science
in the hypothetical world, Farmer science would have entered only a month or so before Apotex and so one should think about adjusting for that too. How important is this incumbency? In helping to establish market share? So fortunately, we also looked at that in the IgM paper. It turns out that we didn't find a very substantial effect. It turns out really that you could be in the market for quite a long time. And yet it doesn't seem to give you a particularly large advantage. So looking at all the estimates together, and then I accounting for those. I came up with an estimate of around 3%. That is the extra advantage that Apotex would have had in its market share competing against pharma science because of its incumbency. So I had to subtract that as well. So in method one, just to summarize I take the actual Apotex market share from the time that happened. Pharmacy science entered shift back to the time when in this case pharmacy has already entered in now Apotek centers and apply that after deducting around 12%.
And method one, well, you set the you in paragraph shortage. Did you factor that into your analysis here as well?
I did. Thank you. So in in the real world, Apotex experienced a supply shortage which is reported to help Canada and we see and that was in early 2017. Sorry, I'm just gonna do my report again, what paragraphs
maybe agreed to put it up on the screen for 49 of your first report. Thank you.
Yeah, so in the real world, there was a documented supply of apples zolpidem. And then we see in the months which kind of matched that supply shortage we see also a big dip in sales, which immediately comes back. So there's the supply shortage seems like the obvious reason for that big dip in Apotex is sales. And so I've assumed that in the real So recall that in this method one I'm just shifting Apotex as market share backwards after adjusting for Apotex his size and the advantage of seven quarters of incumbency. So the thing I don't necessarily want to shift back to and impose on pharma science, the assumption that they're putting offered by Science at a corresponding time in 2015. So in order to get around this, I simply interpolate or simply I just draw a straight line across from before the supply chain to after the supply shortage and as assume that in the absence of the supply shortage, Apotex sales would have followed that trend. And then that's what I'm using for the estimated sales or market share of pharma science in the hypothetical scenario.
And you've provided the results of this all of this work in your H dash six fast crash analysis shedule age death analysis. That's right. And you also looked at this a second way. Can you describe that for the court?
So the reason for doing this is that in the real world, Apotex had a really quite a strong position after after pharma Science Center they really continued to dominate the markets. And so, the question here is to you know why that is, is it something specific to Apotex? Perhaps or is it specific to the zolpidem market or something that's just, you know, maybe specific to a particular combination of Apotex and zolpidem that having established a position they really wanted to keep it and were willing to fight for it. I don't know. But it is striking that in my method depend on Apotex his share of the market and Apotex his share of the market is really quite high. And it is higher than you would get if you were just to look at the iGEM papers estimates of what the likely market share would be for the case where a firm enters and then another larger firm subsequently enters you know, a month later So, what I did was to calculate directly out of the assets from the IgM paper. The predicted market shares for Apotex Pharmascience given their size and given the entry timing that is to say that pharma science centers in January and then Apotex in February and given the the relative sizes of the Canadian and I predict the market shares just based on those features of the company that is say the entertaining and the company size. And that yields a somewhat different set of predictions that start around I think it's 59% Immediately following Apotex entropy and then I'm sorry 59% is the predicted market share science immediately following Apotex his entry? And then that that declines
over time period,
so provides a more modest prediction for what pharma sciences advantage would have been roughly sort of 10 to 15% in this case, as opposed to I think 30 or 40% in the method one, so method two, don't perfectly line up. And so, that the question is, Well, how should I deal with this?
I might actually just bring up 56 of your report, which is where you discuss this Yeah, so sorry to interrupt.
Yeah. So, as a general rule, I think it's attractive to use
data from the actual market as much as possible. That's method one. And, you know, the all. The question is, what are the features of the what was the thing that made Apotex such a strong competitor in the old open and marketing in the actual world? Something about the relationship between Apotex and pharma science? Was it something about the zolpidem market itself that maybe the first entrant has some big advantage? Was it decision not to enter strongly because the market wasn't really that interesting to them when they actually entered? I don't know. So of course, they're always sort of idiosyncratic features to every market. So the advantage to using method two is it just takes out all the idiosyncratic features that says we don't really know, what were the things was it something that was just idiosyncratic that would never have been repeated? In which case Method two is 100% appropriate, or is it something that was maybe the first generic entrant to the market has some huge advantage in the zolpidem market particularly, in which case method one would be appropriate given this uncertainty about why the zolpidem market turned out as it did, I have an appropriate approach was to basically just split the difference. And so I've ended up at method three, which is the average of methods one and two.
And you explained 56 why you believe this approach is reasonable and the last sentence?
Certainly So as it says, it incorporates information from the zolpidem market that is to say, how the first generic entrant to the market performed from other analog markets, as we did essentially by drawing from the idea paper. While in both cases, right, it's important to emphasize that in both cases, I've accounted for any effects that are likely to be related to firm size. The difference between Apotex and pharmacists in terms of size and entry timing
you made for changes to this analysis in your August revision report. Can you explain why and what the impact of those changes?
Certainly in the August revision reports, again, I'd been given this information that in the hypothetical scenario, the OSI listing would not only have been delayed for pharma science, but the OSI listing would have happened at the same time for Apotex. And that led me to feel that the advantage of being first for pharmacists would have likely have been somewhat rigid. And here we just don't have good information about this. But it seems that while pharma science would have been in it would have had its product wholesalers would have had those products then distributed into pharmacies. It would have had lovely few sales in advance of the so that made me feel that the more conservative approach of using med two would be appropriate for Ontario specifically. So my method three for Ontario only turns into essentially method three, method two that is to say, I only use the data from the from the hijab paper to to predict what would have happened in on in Ontario in terms of the relative marketers, between pharma science and
Apple Apotex, the impact of this revision as expressed in paragraph 25 of this report.
It leads to a pretty substantial decrease in the predicted lost sales of pharmacy science. And effectively it means that since Ontario is a particularly important market for zolpidem the is the average which is constructed between methods one and methods to really is much closer method to essentially my my final estimates are relatively close to the predictions that arise from just just drawing from the job paper.
Thank you, Dr. Haas. Can you now tell the court how you compare or contrast at this stage to recruiting Garston approach?
Certainly, so, it's maybe helpful just to see that there are kind of two main differences between my person that abducted goat endorsed one which I'll come to later is they that Dr. Grill assumes that the two firms enter at the same time or treats them as having interest at the same time. And second, just what I want to discuss here is the the approach of essentially Dr. Gruden Dorst does something like that one. So, recall method one I draw from Apotex is market share, and then make adjustments for relative size and the incumbency timing. Doctor Dr. Gruden during draws from pharma science is market share full world and then makes adjustments for I guess, just for timing. And, in both cases, whether you're in the real you're drawing from real world data and zolpidem and in both cases in drawing from The Apotex data, or market share you end up with a relatively high market share for Apotex Edwin in the real world that farmer science had a relatively low market share. So Dr. grinder is essentially starting from a low real world base and then kind of boosting to adjust for entry timing. And I then results in numbers that I think are implausible and the reason that I prefer my approach specifically here is that the ROI idea paper shows that entry timing is something that's really important. As opposed to the characteristics of the firm's in terms of the size of firms that itself is definitely a smaller feature just to put it into context, the effect of being first we pretty robustly made at being around 28 29% compared to not being first, but the fact of the market, the size of the firms, you know, we're able to find all that here between the difference of the firm sizes we're looking at, you know something like 9% so I'm quite comfortable using method one, method three, sorry, method, that method that Dr. Group uses. But having said that, I even prefer the approach of actually averaging with the all the data that we have from the
now Dr. Hollis to a stage for what's the position, your relative positions your doctor with respect to the adjustments needed to be made.
Here we both applies i and just if I understand Dr. Gruden doors analysis correctly, we're here to fully agree that the approach of adjusting for the difference between the IMS sales and cumulative sales recorded in ex factory is an appropriate approach and what it results in is several months of inventory in wholesalers that is captured in the IMS data and that needs to be captured in order to appropriately account for the likely sales that some form of science would have had to wholesalers but it would not have been recorded by IMS.
Now I want to your reply report, dated October 11 2021. Dr. hauless you put that up on the screen at paragraph eight understand you me that your earlier analysis.
Yes, there was
a small change in my predictions.
And we move forward to paragraph 37. Justice if I might, I've just been advised that the third report as marked as an exhibit needs to be added to by the inclusion of FC 3313 which is Dr. Hollis HR six analysis corrected. So if we can make that part of exhibit 127 That would be appreciated. So what are we adding to 127? FC 313 which is a it's a sheduled that should have been there. What's your exhibit? 120 So thanks and if we could move forward to paragraph 37 of this reply report.
This is under the header of might of Dr. Gruden doors report. Can you tell the court what it is you're saying here?
While I was comfortable with my first report Dr. Gruden presented another way of presenting that the way that we are presenting what I did in port and I think did so in a way that offers some useful crap. So, adopt adopting this report exactly the methodology the impact is very simple of the numbers but for example he uses age as being 1/3 of a quarter for when Apotex enters because it's just one month instead of having just used one is what I did. And so there's some other minor effects on timing which result in relatively small changes. I'm comfortable to adopt the approach that he's done. Dr. Burton doors has been for many years, a collaborator, colleague and so it's actually rather nice to be able to accept, in this case, a what I deem be a friendly correction. So I've opted those and I've I show the methodology in my
modified that's the one we just spoke about adding the turning ahead to paragraph 40. No agreement with I'm
certainly. So Dr. grinton doors in a way that I find puzzling, says that treat pharma science Apotex. as having entered at the same time, and the basis for this appears to be that in our IGF paper, we had only quarterly data. So therefore, in the IGF paper, we wouldn't have been able to distinguish between when Apotex and pharma science entered this market. And therefore, if we were on I believe the word to use is strict on Strictly speaking, if we were to consider as being sort of in the IGF paper then we should see that the firm's entered at the same time and treat them as having entered at this time. I don't really understand that since in this we actually have we know from the assumed counterfactual assumptions that Pharmascience would have entered about five weeks ahead of Apotex. So I don't really understand that but the result of his doing that is really substantial effects in his modeling of the relative market shares. So, compared to Dr. Gruden Dorst, I treat pharma sciences having entered a month prior to Apotex in the bond world. He also makes the observation that I should have used model three as he does I I don't agree with that. I used model two because model two allows us to estimate the effect of the differentials the difference in size between farmer signs and Apotex on their predicted sales. Market sorry, model three which he uses doesn't allow this prediction to happen because it uses as he says, fixed effects. The fixed effects essentially eliminate the ability to distinguish what's the effect of firm size and for him that doesn't matter because he's he's using science as sales in the real world to predict pharma sciences sales in the actual in the hypothetical world but for me, it matters because I'm using Apotex sales in one or I'm just using the IGF data generally in my model two
and you explain No go ahead.
So I need to be able to account for the relative firm sizes and to do that I need to use model two.
And you explained how you did this in paragraph 41 of this report. Is that right?
I don't think you did you go through the details but I just wanted to ask you. You told us earlier. I believe that he didn't have the data that you'd used in coming to the analysis in the IgM paper. But you're referring to the models here. Can you explain that for the court?
I don't understand your question. I'm sorry.
While you're talking about in paragraph 41. Applying changes to the inputs in Title four, I believe so you have the models, but not that
I think what is I have the code to be able to Yeah, run the regression in the IGF paper, but I don't have
the data that you had used with Darstellung to come up with. That's correct. Okay. It's just that you've been to the AGM the data in the paper and I think you don't have that data. No, right.
I don't have any of it.
And what's the net effect of this change? Oh, God adopting endorser. Suggestions.
It's some very small tender, perhaps a percent I'm not quite sure whether I've have it in this report.
But a paragraph 46 Maybe that'll help.
Yeah, so apparently, decreases my estimates of pharma sciences by roughly 1.2%.
Thank you. Now moving to paragraph 47 under the heading errors in the gluten darsky report and explain to the court where you say Here
is Dr. Burton Doris states in in his report that the iGEM paper found that all generic trends that accrue their first sales in the same quarter experiences similar first mover advantage I would just point out that that is not anything that we could have found. As the papers clear about the data is quarterly that we used in that paper and so it would have been impossible for us to estimate what was in fact, the effect of firms entering in the same quarter if we didn't know which one came first. So the thing is, of course, we couldn't know which one came first if we were using quarterly sales data to estimate the timing of entry and in the paper however, we do mainly use no see dates, to estimate the which firm came first. And when we do that, we do find in fact that the firms that enter first are the ones that are getting a substantial benefit from their first entry. And we don't find anything like what Dr. Guten Doris says that I've quoted here. And this is quite materials and so basically it enables stockroom doors to that point to claim that since we didn't find any such effect, that we should just treat Apotek and usciences having entered at the same time.
Can we scroll down to 48 the court where you're saying in paragraph 48.
Here again, since he's claiming that we should treat them as having entered at the same time, then the only differences that we should be looking for are should be the ones related to their sales and marketing capability, which, of course, he's drawing from the real world situation in which as I've already discussed, Apotex, actually did maintain real primacy in the market relative to pharma science. And so that enables him to kind of justify using the model that he does and claiming that basically there's this huge advantage to Apotex from its sales and marketing capability relative to the science, which, if it were true, would be reflected in all the other markets in which they compete. And in my understanding is not
and finally, Dr. Paulus a paragraph 40 banking explain what you're seeing here.
I mean, this is just that good endorsed seems to suggest that I'm claiming some massive market share advantage of pharma science. In fact, in my report, I ended up as I said, a roughly I guess the market share advantage which I estimate at the end of the day is between 18 and roughly 10%. Over the course of the the two years.
Oh, thank you, Darla, those are the questions I have for you today. And would this be enough time to take the morning break justice, then it says, do that, counsel, Dr. Hollis my discussion with Mr. stainsby consider you your cross examination length will take 15 minutes and resume at 11 o'clock. Thank you
Thank you recording stopped Yes ready
by can start my video There we go. We're ready to go as well.
Mr. stands behind stopped your video because it was left on during the break. I didn't want to
Oh Thanks we're back Mr. Hollis. Are
you still Dr. Ellis Williams
recording in progress. clinic now resumes this golden egg Good morning Dr. Hollis.
Even earlier in the morning for you than us. I guess.
It felt early this morning.
I bet you're bad. So just want to go through a little bit of a background on on how on your involvement in the case if you don't mind. So we had a look at the code of conduct that you signed and it looked like you got retained in in July of 2018. Does that sound familiar?
So that's three and some years from for a tenant? Yes, yes. And at the time, you were retained. Did you did you understand that the examinations for discovery had not yet taken place. Are you informed stage the case was that? I
I don't know. I wasn't in to my understand. I remember being asked for advice on what materials to seek and discovery.
Okay. So I, maybe maybe my notes are visible from your sitting, because that was gonna be my next question, which is so you weren't consulted on? On what to ask for in the examinations for discovery. Is that right?
I don't remember that. So that was I was just using that bit of information to help me whether discovery had taken place,
right, fair enough. And so if I told you that the first round of examinations for place in 2019 You wouldn't know one way or the other.
I possibly looking back in my notes, and maybe I would have felt like had an email to me that they were getting this information or possibly. I don't remember.
Right. But you didn't just to be clear, you didn't provide input to counsel for the plaintiff on things to ask from meta or Valley and in this case, to your to your memory, you didn't do that. That's right. And so when we look at and I'll be going to your reporting from time to time, to the extent you want to look at them please do so if when green green chair too, but I it looked like you had them up on a second screen. Yes. Okay, so in your first report, and I think Mr. Stains we took you to this earlier, but you said the documents that you relied on, in a section helpfully D data review that starts at paragraph 16
of your report. And
it's not a lot of material hopefully so fair to say that what you relied on in preparing your first report, from this case, things you didn't already have from your research or elsewhere. Were at first, a collection of IMS data relating to the Zopa market. 2015 to 2018. Yes, yes. And if I, if I refer and I know the months aren't exactly on but if I if we think of 2015 2016 as the delay period, and 2017 to 2018 as what we've been calling the prompting period. Do you understand what I mean by that?
Yes. Okay. That's that's
off for so but that's a reasonable estimate. Fair.
Sorry. Can I just get you to tell me again, just in case you're referring to the proxy period, if you're going to use the word proxy period, that means,
yeah. 2017 2018 When When Apotex and pharmacists are both in the market, competing against each other,
so that would be a proxy relative, relevant only for thinking about generic our shares of the generic market and surely not for any of the other components. Just so we're clear.
Right shares the right chair the generic market, right, as between Apotex and pharma science, right.
Yes, as I used in my, I guess it would be the relevant proxy period for my method one for Dr. Gruden doors approach for estimating relevant the relative market shares,
And then as you note in your report, you also relied on to at interest internal farmer science productions relating to their ex factory sales, right. And you use that in the paper fill adjustment that you talked about at the towards the end of your testimony with Mr. stainsby. Right. Yes. And understand correctly from your report, those were the three documents you used in preparing your first report that you didn't that were provided to you from this case that you didn't already have. Is that right?
Those are the those are the ones that I rely on here. And they didn't have Yeah,
yeah. They all relate to zolpidem specifically, and they're all from the 2015 to 2018 time period.
And then, in the, in your second report, the one from August, you relied on some additional iqvia IMS data in in providing your opinions and your second report, correct?
And I didn't see any other documents productions, Discovery transcripts, any of any of that stuff referred to in your reports other than what we've just discussed. Am I missing was something else that you relied on in preparing your opinions from this case?
Clearly, part of it is relating to the iGEM paper.
No, I meant like that was provided to you from this case by case was opposed to what you already had in your possession. I
received the information from Miss Bakowski about the dates, Brian for the LFR interchangeability designation.
Fair enough, fair enough. So, and Ms. Borkowski to report? Yes, yes,
I think that's, that's it.
Okay. So let's just talk I just want to talk about documents and information that you didn't appear to need and so in in your analysis in estimating pharmacy losses in the but for world you didn't need documentation about valiance marketing efforts for subblocks in 2015 2016 cursor.
No, I didn't see your need that.
Okay, and same you didn't see your need documents relating to vans, marketing efforts for simpler knocks in the 2017 to 2018 proxy period, right.
I don't recall that in either case. Of course, the reason that would be relevant for sort of the total sales or the generic share of the market positively. And in both those cases, the answers seem to be fairly straightforward. Yeah. Since Apotex had entered just a month, the counterfactual entry of pharma science
and you're at your again, so you've saved me three questions, but if you can just answer the question that I've asked and then I'll go on to the next one, after that, so a few there were a few other things that came up occurred to us and maybe the same reasons, so bear with me here at 5am and demand prediction, that valley in its Sublett ox product about between 2014 and 2018. Not relevant, correct.
Haven't seen them? As far as I know. No. I wouldn't have needed them.
Right. Same thing. valiance 10 year commercial plans for subblocks didn't see it. Don't need it. That's correct. valiance marketing budget for sadhaks didn't see it. Don't need
it. That's right.
Whether Valley can continue to hold advisory board meetings with prescribers after genericized ation, didn't see it. Don't need it. That's right. Valley in sip, spend on an ox brand from 2015 to 2018. Didn't see it. Don't need it. That's correct. What about we're aware that there was a an ST Dino with the SD card program is STI card.
It sounds like it might have subsidy consumers but I don't know particularly.
Okay. So if I told you there was all the STI card program in place for valley and then for sub, typically that wasn't something you asked counsel for that you needed in doing your analysis, correct.
And same is true for for the the number and identity of hospitals covered by valiance healthpro agreement regarding the setup on oxycodone see it don't need it. Right. What about again, I think I know the answers to these but it would be on them. What about valiant products other than subluxed other products failing had that had been genericized at some point in the past Did you ask for information from Valiant about that in the course of your work? With on this case?
No. And I assume you always know the answers to the questions.
Well, let's hope so. Not always, not always. But if we get to like 85% We're doing good. So I'll just throw out a few names for you of other products at Wellbutrin XL, did you you didn't need internal Valliant information or out about the generalization of Wellbutrin XL Correct? Same is true for Al tastes
Ah yeah, another product. Oh, Al Dara one. That's al de Ara was another valiant but when generic you didn't ask for need anything relating to L Dara No. at S says that C E S A M E T. You didn't need or ask for anything relating to the generalization of sets on that correct
The Zopa ad Did you did you did the Zopa clone market or the molecule Zopa clone for your analysis at all? No.
And so just as well, one or two more questions, and what about the meta defense? Did you need to learn anything about the meta defendants to conduct your analysis of losses? No. And so fair to say then, in your defense counsel over the years, you didn't identify anything from meta or valley entities needed for you to come up with your analysis of the but for World correct,
given the timing of the relative energy, dates, no.
Okay. Now then, we're going to go into another sort of historical area here and want to discuss some of your prior experience and testimony and you you know, some at footnote four of your first report, I don't know if you want to pull that up for yourself. That's in page shete. Three of your report at the bottom of your first report, the one from July 4 is footnote four let me know when you're on there. Okay. Great. So there are we see there's three listed there by by drug and, and court phone number. Do you see that? Yes. And the first one listed there is relating to a drug called Safa. klore. Yes. And in that case, you were retained to provide testimony by counsel for Apotex, is that right I
think it's getting to be a while ago.
Well, I think everyone involved in the Safa Clark case wants to forget the seven o'clock, but as so that's fair, but do you recall that that Ms. Makovski was also an expert in that in that case? That sound familiar? I haven't
have a recollection of that.
Okay. And then the second one in footnote four is grammar pro case and there you do say on behalf of Apotex, so hopefully that information is there and that's accurate to your recollection.
And do you recall, who provided information about formulary list data in that case?
I recall that basically you did some kind of analysis on formulary as opposed to relying on an expert. Everyone decided that was a bad idea. Fair enough. Well,
you know, Fool me once shame on you. Fool me twice. Shame on me as they say
Judge Snyder justice Snyder was, however, accepted my testimony in that matter. So including regarding the timing and
Fair enough. And so then, Casey, you identify there is is the venom facce. Hey, were you you were retained by Teva? Yes. Right. And in that case, counsel for Tebow was a can CLI the Vermont for pharmacists here. Yes. And in that step, as you say he learned your lesson, because he was the formulary dates expert to recall that.
I think that's likely to be the case. I just don't remember specifically
or so. Okay.
Fair enough. And then, we have I have found a few other cases that aren't noted in your report, but in which you acted as an expert and I think you mentioned this morning. You've done this a few times. olanzapine? There was an olanzapine case between Teva and Billy relating to Section Eight. Do you recall testifying in that case?
The Testimony itself? Perhaps not but generally the case yes.
Yeah. You weren't you were retained. Teva records represented a CLI in that case? Correct? Yes. Pre gambling a couple pre gambling cases. There is a pre gambling case between Teva and Pfizer that took like two years of your that one? Yes. And in that case, you were retained to desist. The generic company Teva and counsel for that company was Aiken County, correct? Yes. And Mr. Makovski provided expert evidence in that case, recall for goblin Teva?
I, I think so but I just am stuck in numerous cases in which she has been the formulary data expert.
Okay. And then a more recent ones a second pregabalin case for pharma science, that one and I went to trial this summer. Do you recall that? Yes. And in that case, farm assignment was the company that you were assisting and again, representing,
And these last few, the olanzapine pregabalin weren't in your word mentioned in your recall, work as an expert in those cases as I've described correct. And, and then we found a few older case as well. Where you appeared to have been assisting appetite in the lender, Nate section eight case one of the early ones. Do you recall that? Yes. Yes, I see. That that one must have been quite the effort given it was sort of the first breaking ground for the rest of us in that one. So members, we have you down as an expert for Apotex in the context interlocutory injunction. Do you recall that?
Perindopril another apeks this time against serving and all that? Yes. We've got a case involving Apotex and Allergan relating to the drug combigan to recover. Yes, and there you were assisting Apotex as well, is that right? That's correct. And so, in all of the cases that I've described, Dr. Hollis, you're the expert assisting the generic company. Is that fair?
That is fair for those cases.
And you've been told by others as well. Yes. And are there cases to be fair to you? Are there cases where you've testified in court on behalf of an innovator that we didn't find? No,
I have been returned several times, including in a case just
In all cases, the cases have gone to either settled or or they concluded without the need for my testimony become public.
And so we were talking about you're moving to a sort of a different topic, but still in the background, kind of second that we were talking about when you had been retained and the discovery process, and I've done going back there, but I do want to talk to you for a moment about the sequence of events this summer. So you provided an expert report. In in the first week of July, shortly after Canada Day. Right. That's your first report.
July the seventh.
And when did you start working on that? Report? Dr. Hollis, do you recall the general I'm not looking for the day but what was it? Two months, one month, two weeks, six months? What what sort of time frame are we talking about here?
I'm guessing months, but I don't really precisely remember.
Okay, but after you prepared the July report, you you revised your report in August. Right. That's right. And that was to incorporate the opinions in OB skis report also from early July, right.
Yeah, I'm not sure when the report is dated, but I trust you a few
seconds. And so
we turn to your first report or you have your first report up I'd like you to turn to Section II. That's on page seven, and is concise section three, and 24 of your first report when you're there. I'm there.
And Section D is headed summary of the Canadian pharmaceutical market you see. And you begin section by noting at the beginning of paragraph 23 a few features you say that are worth understanding as preliminary report you see that? Yes. And paragraph 23 talks about public and private insurance. Right. And that's an important term in pharmaceutical market. General the insurance that people have in the distinctions between them fair. Yes. And then at paragraph 24. You are assessing provincial interchangeability and and off formulary interchangeability, correct? Yes. And you you say in the first sentence that puts rules for pharmacies and pharmacists, you see that? Yes, he talked about that a little bit. This morning with Mr. stainsby. And then you, you said plain more fully below some provinces grant, a designation interchangeability, which enables pharmacists to substitute one product a generic for another a branding drug prescribed by a doctor without liability. Can you see that?
I mean, you're such a complicated concept, one sentence there, but as I understand it, the liability concern you're having there is that a pharmacy, prescription product name on it, Product X app, but if there's a generic of that the interchangeability rules allow them to dispense the generic as opposed to the thing that's actually written on the prescription
fair. Yes, in process or the interchangeability designation is given.
Right? Yeah. And they're not going to get the liability concern you're talking about they're not going to get in trouble for legal trouble for having a piece of paper that says Product X and giving the patient product why because the government said you're permitted to do that.
Otherwise, they need to call the physician and say I got up for x, but there's a generic product why and I want to just better patient one, because it's cheaper or their insurance requires whatever the reason, do you mind? Right? Yes, if
it's written for the brand, yeah, they want us prescribe as dispense to substitute otherwise the product may be written for the self. If the prescription isn't generically then of course, the pharmacist has just the power to dispense a generic or the brand,
right but in this scenario, I'm describing product X is the brand name for that product, but there is a generic app. So let's say subblocks. Amo put um, if a physician if a if a pharmacist, if a patient goes misses with a prescription that says subblocks on it. But for those zolpidem or pianos OpenMW is already on the market and it's on the shelf behind the pharmacist in a province where there's no interchangeability, the pharmacist would need to call the physician and say, I have a prescription for subblocks but for whatever reason, I want to dispense the generic Is that okay? Right. Yes. Yes. But where there is interchangeability, or the pharmacy permitted to make that interchange without risk of liability for giving the patient something different than what's literally written? On the to correct? Yes, right.
As I think you mentioned earlier today, and as you as you know, for a second report in the August report, and interchange is a strong push for is a significant benefit to generic sales for products, right. Yes. And in part, it's, the pharmacist doesn't want to have to call the physician every single time much easier to just switch right. Yes. And in paragraph four of your first report. You say as more fully below and but you don't actually address interchangeability or off formulary interchangeability anywhere else in the report. Correct?
That's correct. way
below is the
incompetently paragraph 24. It's just those that you don't there. Was there another version of your report that had more off formula interchangeability or something like that? At some point no. This was it. This was it.
And so then let's
so but just to
pause here at paragraph four verse report you were aware of off formulated stability at the time you prepared your first report, correct? Yes. And you were aware of the potential impact of off our military injured at that time? Yes. Yes. Okay. And when you prepared your first report that had been retained as an expert in this case, no. right through to the signing of your report on July 7 2021, counselor for pharma signs never knew that they had retained Ms. Makovski. You know
what I need? I don't know. That's a good question. Since I must have Well, I would have never done that. There were four.
tree I mean, I don't I don't remember. Knowing why there's a chain wouldn't necessarily be a particular. Like, I'm not sure whether that's something I would have focused on.
I wasn't asking you if you were focusing on it. I was just asking if you knew who that well, you you must have known that it was going to be an accountant to or last volumes are going to be fed into correct certainly. Yes. And did you know who that person did you know the name of that person? Did somebody say it? You know, Errol needs your report. Where is it? At some point? Mr. Sorry, I know Mr. Sorry, I know as well so I use his first name but it is court so I'll Rana did somebody at some point say Mr. Sorry, no needs are. Your reporting needs your volumes. Did you know who it was? I mean,
I don't know the accountant and never met him. Or so I don't really know. I wasn't sort of aware of who the accountant was or interested to. Be honest with you.
That's fair. So. So I want
to take it to your if you can open up your second report for that one. That's described as a revision the one from August of this year.
So can you ask me I was sent a folder of documents but they don't have names on them. Assignments. Numbers, FC something Can I Can you which one that is otherwise, I'll go hunting elsewhere. That's a
complicated dude. So I hear you.
It's 47. I've just decided so that's okay. I think I'm okay to get this it's 000 47
I marked it
Okay, so it should be a relatively short document that with the title page revision, expert report and maiden Hollis, do you see that? Yeah, we have a great test. I want to go to the second page of that PDF, the first page of the report under Heading a mandate and summary of opinion. Let me know when you're there. I'm there. Okay. And at paragraph two in the third sentence, you say, been advised that the expert report of rosemary key de la 520 21 sets out the but for World listing date, not provided with the BUKOVSKY report. At the time that I prepared my first report you see that? Yes. And so that's written there that's accurate. You when you completed your report on it. You didn't have MS Makovski report and you did not miss BUKOVSKY is your report correct? That's correct. And up to July seven at 21 not been provided with any drafts or or off formulary dates or anything from is blocky. That's correct. So, so pharma science retain Mr. Makovski. When all the way through the process of preparing and finalizing her report for input into yours and never, never even told you about that.
I mean, I don't know what I did, but
we're having an issue here. If you can just it's not a big deal, Justin, but I don't know how this witness tell. This court, what our clients did or what farm things were that was kind of a loaded stone but to the witnesses. Appropriate. Maybe you could read the question a little bit. So
you've seen Ms. mcob. Skis report dated 2021. Correct. Yes. Yeah. You incorporated it into a report. Yes. Yes. And it's reasonable. That
you've seen it.
And so you you if you looked at you may not, but she was retained in January of 2020. I don't know if you notice that in the report, but it's in there and it's a trial event. And you don't have any reasons to doubt that right? No. But up to like, even 2021. When you finalize your first report you you were unaware of her involvement in this specific case there.
So we we've already been over my extensive extensive my awareness whether she was involved in the case,
take over the role, knowing that it was in the case, and that had been she'd been read.
And so right and
I'm suggesting must be the case the sequence of events is that Bakowski was retained and prepared a report that you then later received you were never advised of that until after
first report. Right. And so you have no idea why
or science or they can clean them that that was working with you didn't tell you about this because your report you have no idea why that is correct.
No. I mean, that's correct. Sorry.
I don't know why they did. What they did.
and so when let's let's look at the sequence of events between July seven and more. Second report, which is dated August a twin to find out about Ms. Makovski. Well, that's when did you find out that Mr. Makovski had provided an expert report in detail.
It wasn't immediately submitted. This would have been some weeks later, perhaps near the beginning of August. Something because I remember that as soon as I
The pitch release suggested that I needed buys my report that I had done work to do this and quickly. I was like this was urgent.
from learn from and and we're just advised that there was a Bakowski report where you sent the report and said, you know, consider whether this impacts your opinion. How did that pan out?
Cisely remember, but I was advised that at least there was it contained dates that might influence smartboard.
And your recollection from that time period between when you were contacted about this and the August 8, date of completion of the report was relatively brief. In them in the order of a couple of weeks.
Again, I don't precisely remember the timing, but I know that it was it was okay. And that was you know, I had to do like obviously a proper job. I mean that I had to essentially attend to it immediately.
And as I kind of went that you you prepared your second report a little in August. Yes. Yes. And the, the, as you know, in your paragraph for if you like that page of your second report up was a reduction of about 10 cents in firm usciences losses Correct. I'm a little bit concerned when I'm supposed to be hearing something. No, no, I put myself on me like consult with my colleagues. I was just I wanted to make sure that. That is one of the benefits of the few one of the few benefits of the Zoom hearings is that if people are in the same room, you can just put yourself on mute rather than whispering or sending notes like like in grade school. So I want to go back to your free course now if you don't mind
and into the section immediately after the section we were just that we went off into the second report we were at Section II, page seven of your first report I want to look at Section F sections which is Section E let me know when you're there. I'm there.
and so at paragraph six you say that it's by counsel that in the real world. Apotex received notice of compliance on December 31 2014 and December 13 2015. You see that? Yes. And so, just want to pause for a second on the on the term yield world. And so what I think we're, I mean, it's funny because these are section eight cases and they're a little bit weird real world is what actually happened, in fact, right. Yes, like, historically, the real pay isn't something we're making up. It's the things that actually, if we look back in time, right.
I hope we can agree on that.
Well, it can say when you're comparing the tuning, but so you do what you do agree on that right.
When I use real world here, that's what I'm referring to is the things which actually occurred.
Right. And so you accept as something that actually occurred that Apotex Steve and NOC for its generic Zopa product on December 31 2014. Right, as an assumption, yes. But it's that because it happened in the real world, you could you could have gone the NOC database and confirmed it for yourself, right?
I haven't so I'm confirming it as an assumption that I assume that's what happened.
Okay, at well, we can The Apotex NOC is a trial exhibit. So let me help you with this if we could. Trial exhibit four and you've been I assume, Dr. Hall is the Health Canada's and I'll see online. Yes, yes, many,
many times yes.
This is already an exhibit I don't you know, need to authenticate it but do you recognize this as the format of a printout from the NMC database? Yes. And the information on here tells us that in fact, Apotex did receive a notice of compliance for its generic subblocks on December 13 2014, right. And this is something that happens in the real world, which is why it's on there. I don't know where LC is, right?
And you include Apotex in your but for World calculations correct. And that's because you have to they did, in fact, get a notice of compliance. And so they're there whether frontline science wants them there or not correct. Yes.
are you aware that there were a meeting that Apotex took to commercialize its product in service of compliance? No. Okay, well in in Ms. Makovski. His report, which uses and review she firms that they had their submission to the Ontario formulary are completed and filed by January 7 of 2015. Did you notice that in her report? No. Okay, well, let's let's pull that up for a second. Then. So. We talked about the kautsky yesterday. Well, but at paragraph 116 of a report
she you don't have any reason to disagree and you don't disagree with the opinions that Ms. Makovski is providing her report correct?
And so in parsing scene of Ms. Makovski his report that she said area and a pose OpenAM submissions would have missed the 320 14 submission deadline and met the January 7 2015.
and then next sentence she says PMS has opened them would have been on the complete streamlined multi source of submissions for off formulary interchange Report for January 23 2015. Do you see that? Yes. And if we go to that, and she cites a document her three point 16 And we're gonna pull that up on the screen. Any of you have you gone to have you ever looked at formulary? Well, he must have looked up formulary documents. Yes.
the title of this report is bold, but I'm not going to repeat it but it's the same mouthful that I
ran into. Correct?
Yeah. And we see the two rows. There are Apotex. It's a bozo put them abt project that Yes. And so what this indicates this, again, is a publicly available document from the Government of Ontario, right?
I don't know I've never seen this before or this, like a streamlined multi source wherever.
Well, he would have seen it in Ms. Makowski. His report reviewed that right?
I mean, I reviewed the relevant dates so I don't I don't claim to have read every word in his Bakowski report.
But you have no reason if he cites this as the complete streamline multiple missions off off formulary interchangeability report, you have no reason to doubt that that's what is that this in fact, is is a real document Correct? Right. I
mean, I don't claim to provide any kind of authentication but beyond what I could do as an expert. Yeah. To to claim that she lacks expertise
or that she would have made up this document I mean, she right. You're not suggesting that it is, as far as you're concerned. It is what it is right.
I'm just as in my mind just doesn't seem appropriate for my friend to be cross examining. Call a sudden Makowski his report she said things report she had driving things and I don't want to get into it here but just just sort of in an appropriate line of questions for her for Dr. Hall.
To ask questions about this specific section of her thick exhibit, as I recall, so I don't think there's any assists Dr. Hollis in confirming something I'm not aware of any restriction, providing another trial exhibit to an expert witness and seeing what they're
gonna find might be justice. And he says he's not seeing this before. He does not know the provenance of it. He doesn't know if it's public. I don't know what we're accomplishing. When if my friends right and it's been put them in court. That ought to be the end and respectful. Well, let's ask the question, if you will, Mr. Stone.
Okay, so then let's go to paragraph 116 of Ms. pakad sqillzer.
And so well actually, no, let's go back to the one I was just looking at a bit bit 16. If we scroll up. You can see there's January 23 2015. On there. Yes. I fully agree on that. And so
certainly, as CSX
information as to what the sequence of events have been to lead up to this but a yellow except it was a real worth act that Apotex had taken step up in January of 2015. To get its product to make submission its product to the Ontario formulary Yes.
Now just just I have a problem with this because in fact, there's an implication it's best if Dr. Heartless isn't isn't in on this. I think that's going to move us to private room. Just to say that, I just need your attention to paragraph 84 of Ms. Bakowski report, where she says quite clearly, that she's been asked to assume things such as the application date for a Wi Fi designation, and until she had bi and she finds this assumption to be reasonable, but she's not giving evidence as to the fact that this happened. Mr. Skoda's whole line of questioning here is based upon the implication or in us evidence that things happened in the real world. She's taking them as assumptions. Assumptions are reasonable. But that's completely different from establishing more real world
facts. Can you tell me what they're asking? 8484? I'm going old school paper that's fine. That's fine. I'm used to that. Well, your point my point is that Mr. Snowden is putting these various propositions to Dr. Heartless, as though Ms. Makowski has stated them as, as provided. These are things that happened in the real world. She's saying that Zoom things happen and there's a reasonable assumption that that's a different thing, from actually having
it happen happened in the real world. She's been asked to do that, but for worlds or Apotex would be the same as the real that's what she was asked to assume. And that's what she says in the form is reasonable. And then she should go back to Texas and see the notify designation Ontario. Ie 57 days after the date of the NOC, etc. She's there stating facts as I read that paragraph. Now the assumptions
me. We specifically asked her about this yesterday and she confirmed you can pull the transcript up, and maybe we'll do that we'll pull the transcript. We we specifically asked her and Ms. Baird specifically asked her. We went to this too and we said we can see actually if we go 16 That Apotex did in fact meet that January 7 2015. Deadline because they're published later that month. Ms. BUKOVSKY? Yes, it in on the complete street man. Same report name from Fonterra drug Pro. So we say the X Baird says your appetite back meet that deadline. He says yes. And Ms. Baird goes on day.
Well if we can, because my friends look at the transcript. She says it appears Apotex would have met that deadline
which means it to be on or before that date Miss buttowski Crap. Clay So I I wholly reject Mr. Staines B's objection it's it's it's ill founded. And the point of this exercise with Dr. Halas is to is to confirm with him that Aptech is not oh my god it's and I'll see you on December 31 2014 that actually did something and then sit on their hands for six weeks. They were revising their product and they were doing January of 2015 and we will get to further questions. He didn't if he went with this or he didn't look at ms Bakowski reporter he didn't take those note of these facts she assumes and then true and then Miss bear with her that these things in fact happened. And that fact happened because the effective immigration to subvert them and you know we'll see where, but I don't I don't see how Mr. Sainsburys objection has any merit so what
I agree with you. Bring him back. Continue your examination on this thank you Dr. Hollis. I'm sure you're used to this.
I'm happy to have other very
well that's this finding is
almost gonna take that personally on behalf of other people on this call. So So where we were was in in February of 2015. And I was suggested that Ms. Makovski summarize my suggestion to you that Ms. Makovski and her report and the exhibits to her report suggests that upon receiving compliance in December of 2014, Apotex took steps in January of 2015 to commercialize its product and specifically to make a submission to the Ontario formulary. Is that fair to you? Based on what?
I got an objection here, since there is too much built into that question. I'm afraid I'm going to ask Dr. Hollis to leave again. This is I mean, it's one thing to be talking about what they actually did. And I was incorrect. Yes. She did say five for this is not enough.
Either Dr. Ellis is leaving or he's not.
Well, let's let's sorry Dr. Hollis, you Lynn you have some more downtime. We move them into Thank you Okay, so are these changer hold on video. So my point is it's a question. He's not simply asking her whether Apotex steps to meet the deadline for that many worded report. He's also here him to accept that she said that it took a lot of taking steps to become commercially available. If she clearly notes at paragraph. Let me find it here for you. Paragraph seven, they you can apply for this without having ability to supply so it's not fair to say this, this this to do this double barreled thing and try and get some unseen action that my friends wanted. position that taking all steps to get get bigger available. It doesn't flow from that fact. It just doesn't say that supply doesn't say anything. So you can't use this submission to bolster bootstrap yourself on something so we're going to mean that the doctor has agreed that they they met the filing data report, but I don't think you can add in took steps to be commercially available. It's just not a proper question. Just go back to the transcript and find out what Mr. Stones question.
Of course I can't find it. Maybe the reporter could read it out because it should have
available in it. I think he's I think the were the worst to become but that's what I was trying to find.
Well, my friends having access to what you've got there so we don't have the real time. Well, just a minute let me see if I can. Now can we do it as a reporter go back and read it out to us
Let me see if it's you okay. He said just tested that Miss Bakowski summarize. Summarize, I suggested to you that Toschi in her report exhibits to a report just in
December of 2018. Yep, so in January 2015, commercials and product and specifically to make sure that the formula is that fair to you? That they went and went on just subsequence the last. The last question my friend and asked question was loaded. That is precisely the last question. The last question that we're looking at well, I'm gonna suggest just assume that what the proper questions would have been that they took obtain their listing to become commercially available. That's an argument from what they did the commercial product and specifically to make a submission to the formulary. That's acceptable. Okay. We're doing that thanks again
I wish I could say this time Dr. Hollis. Let's so let's hope it is at so I'm just gonna read the question that I asked you, which is which was a summary of what we were talking with respect to what we what was in what we were just looking at the Bakowski report. And so my question to you, sir, is the information in Ms. Makovski report that we looked at in the exhibit that we looked at suggests that on receiving its notice of compliance since December of 2014. Apotex steps in January of 2015, to commercialization product and specifically to make a submission to the formulary, do you accept that that's something that happened in real world
I mean, I not an option to sort of interface directly with X did
A flying for formulary living in Legion don't know exactly whether that only happens after an noc. So, it feels like a position to fully like I said earlier, did they do this after they got their noc? I don't know.
He before January 23 2015, because on on Ontario formulary report in January, January 23 2015. Right
I would assume and say this without expert knowledge that there's some action required to obtain that list.
Right and the way the way it works being linear for if chef was required. It must have happened before January 23 2015.
Yes. And if
the evidence is such a step was required that would have been it is reasonable for me to suggest that that step would have been taken by Apotex
for its product. Yes.
As opposed to by somebody else.
That sounds reasonable.
Well, I mean, in your experience, being having just sit in and watch the Canadian pharmaceutical market for some, some
years. Post the process of
pharmaceutical companies commercialize their product is by receiving an SEC and then taking steps to get it onto formularies and to pharmacies, right? Generally, yes. They don't just get at OCS and put them in a glass case and marvel at them. They actually do things to sell that product that you know, see religions do right.
I'm sure they're overseas granted, which have never been used.
But generally, it's not generally speaking, companies get n o C's and then come online to their products yet.
There would be a purpose spent money to
give us it's not free, right. And in this specific case, you can see from the iqvia data, you've reviewed that appetite commercialized, commercialize, it's a Bose product, correct? Yes. Yeah. So if we move into a specific we know that Apotex, in fact, did localize its product after receiving Yes yes. And they did that in I even if the even if the date of first sale that you were asked to so February 2015. Are you prepared to accept that Apotex is doing things in June of January of 2015, to move forward with commercialization of its product?
Again, I don't know what that would have involved but am I prepared to accept that as an assumption, or am I supposed to provide expert evidence on what they did? I'm confused.
Are you prepared to accept it as an expert who has experience in this area and sees an NOC December 31 2014 and is provided with an assumption of a date for sale of February 2015. That done must have been activities between those two debates conducted by that company, yes.
And you're ready to accept as well, I think from your reports that in a but for a world where pharma science doesn't get an OC in late 2016, but gets it in January of 2015, that that wouldn't have stopped, attacks. Doing whatever it was doing with its product, right. Yes, you're prepared to assume for the purposes of your, on your expertise that Apotex wouldn't have given up the market if it saw a competitor also receive analyse
possible that they would have done yet my function and the robots that Apotex would have entered and that seems like the bowl thing, given they had already invested in trying to get to the market,
right. And you're not
saying that farmer science could have done in January of 2018. If the tendency to prevent or slow down X, whatever it was? Correct? That's correct. There are things competitors in a competitive market at that point.
And so with its NOC at the end of December 2014, citing its NOC at the beginning of January 2015, this is truly alone in the market, correct.
That's not well,
Apotex has an OSI wrapper is when farmer Stein says it's an OSI right. And so having any NOC means that Apotex is allowed to marketing
products if it has a product to market,
well, well as an MC for an approved product. So it has market authorization, correct.
Yeah, but that doesn't mean that it says
Do you have any paper just just whether it did or supplying in January of 2015?
The information that suggests to me that they didn't have supply as anything? Well, you don't know that as a fact. What I do know is that IMS records notes by them in that month. Well,
like we heard this from others already, but maybe you'll agree that there's a lag between when the sales are actually may and ends appear on IMS data, right? You're aware of that?
Yes, it usually takes time. IMS is being reported just on a monthly basis. So so a one well, yes, you can. The lag is that the sales sort of speak for them. So there's no challenge with seeing you know, in general, if a person actually recorded it you know, when it enters
so that didn't You didn't answer my question there Dr. Hollis app, as I understand it. Pardon me?
I'm not gonna be tricky.
Yeah, I'm just looking at the eye if you just pointed to the ISS data and our standing was that lag in data depending on when in the month the sale happens. Is that your understanding as well?
I'm not getting this data which were reports the date on which a sale is made.
So some of the IMS data if if the Ms. iqvia Whatever shows of first, the month of the first time they're representing at the sale is February of 2015. It's possible they let you know of their reporting practices that some that some of those setups like lace in late
Correct. That's not a thing known, although it what is what I do understand about incomplete reporting is that very, very sales may be picked up by iqvia.
Would you agree that the IQ data showing sales in February of 2015, could be February first of doesn't need to from February
see if I've got monthly dead I really can't say what a is the sales are actually made in the month
and you're not sure in the cut off deadline was in January of 2015. So it's possible there was something else in late January of 2015. That didn't take into 2015 numbers right.
I mean, I think, tell me the monthly data might actually import data for Muslim
not erode slightly by nearer when I mean if you don't know tell me. Oh, that's fine. I'm not asking you to be an expert. I am as I have a certain level of familiarity with with IMS. And so I'm asking you whether you're aware of it or not aware of it, feel free to say I don't know.
I mean, if if the IMS is combining data from months off months, that's something that I don't know.
Give us a moment where
consulting came in to see my mouth nose down it's me not you
okay, don't we just go back a little bit in your report. To
Page Six for work
going to add a reviewed section and so I actually make the page five so you can come home
about this earlier. The sort of three minutes you used for
your first report we're at on the IQ data and for those open a market and the X Factor data for pharma science itself, right. Yes. And you in your report in this section. I know also, obviously in the pipe fills section that iqvia data doesn't allow it. It's a sampling and so it's not as particular as the company's old on its factory data, right? Yes. Okay. And so we're going to go into first
I want to take you to the the iqvia data first
up on the screen
and this is your,
your report. This was the
for the court said reference and I forget what it is maybe it was the FC beat team which was got added to a record I think it's 127.
That's right at the end. So here we sat
on the left hand side The Apotex and the pharmacy sales so we're getting 2015 And so for fighters don't really matter. So for pharma science, we don't see any say in putting 15 And we shouldn't right. That's right
then we see
and we've scrolled over so he's still got the firmest science rows and four sign for December of 2016,
which was which is a
it's still all zeros. Do you see that? Yes. In January of 2017, we start seeing some numbers in in some of the some but not all provinces. And so this was the iqvia data that you use to turn out to the X factory data, let you also use that for your report.
And so we if we look on the left at the top. For the first well everything that's on the screen 34 rows, we see sales in in September of 2016. Yes. And at least or data that you used for your report at pharma science, making sold in December of 20. Late December 20 and onwards but they don't appear in the IMS data until January 2017. Is that right?
Yes, they're actually recording different sales. But yeah, ex factories, record sales to distributors or wholesalers and this CDH data records to hospitals and retailers.
So that might explain the lack the the product is out the door to the wholesaler. So the company is selling but the pharmacy hasn't reported it yet because it either doesn't have it or it hasn't sold it right. Yes. And so that's, that might be Wix explanation. We're not blaming my mess first. But that might be one explanation for why sales are happening in one month. But they're not showing up on IMS until the next month, right? Yes. And this is happening for firma signs out of that you used for your report just saying to you is to accept that the same thing might be happening back to Apotek sales that they might have brought. That might be the during January of 2015 and whatnot being reported back through iqvia until 2015 is that
it's impossible for me to know where X was making sales to wholesalers possible
right and if it happened science, it's not. It's more than just possible. It's a reasonable thing to say that for Apotex
as well, right. That protects it's part of that text was making sales to wholesalers during January 2015. But they were not recorded by CCD which record sales to force the right
justice in this time to pause given it's 1223
We'll take our lunch break then. Whatever that comes out to be okay
what is the German for 140
Thank you Recordings. Check check 123