Pharmascience Inc. v. Meda AB et al - Nov 17, 2021 - Part 2
3:45PM Nov 17, 2021
Speakers:
MR. de SOUSA
JUSTICE ZINN
MR. KLEE
Keywords:
period
experts
model
pharma
drugs
science
relevant
molecules
cross examination
data
admissible
evidence
noon
gabapentin
result
competing
facts
friend
ready
logged
Sound Check 123
Check test
123 Just a quick reminder to all the parties for the purposes of transcription, we just ask that as much as possible. If you can speak slowly and clearly just to make sure everything is as accurate as possible they'll be greatly appreciated
I got them we're ready to go when
correspondence the defendants ready to proceed as well.
Okay. I assume that both parties heard what I just said. But yes Thank you recording in progress
Thank you
are two relevant sorry there are two relevant periods of time here. There's the patent hold period, which runs I believe, from January 2015 to December of 2016. And then there's the proxy period, which follows that patent hold period and continues to November of 2018. Obviously sales have made by pharma science and Apotex absorbed the GM in that in those periods is relevant and admissible. And expenses incurred to make those sales it's also relevant even though the expense may have been paid at some later date.
But how the two companies competed after the period or before the period is not relevant. And non admissible? How they competed against each other with respect to this molecule and with respect to other molecules in that period will be relevant and admissible.
So go to this witness in that chart. That's not relevant, nor is it admissible.
Your Honor. Are we ready to go back to miss Raman?
We are ready to go back to miss Raymond.
Thank you Miss Raymond we had to deal with here was something I appreciate your patience.
No problem.
I'm in Ramin, the topic we were discussing. We're going to skip okay. And I'm going to switch to a new topic and ask you about market dynamics and about the different generic players in the pharmaceutical industry in 2014 to 2016 which generics were you primarily competing against in that period?
In that period, we are primarily competing against a protects Tebah Santos activists in Milan,
and where did pharmacists rank in terms of the volume of sales in that period?
In that period of time, it would have been anywhere between the third and fourth position.
And when you were looking at TSA data in that time period did you observe any regional strengths or weaknesses among your generic competitors
in Apotex was fairly strong in Ontario because it was their backyard they manufacture here in Ontario.
And what about pharma science and regional strengths? They're
the same token we manufacture in Quebec. So we were stronger in Quebec and our pharma science was founded by two pharmacists from Quebec.
And in your time at pharma science, do you recall any examples for pharma science launched first and alone followed by Eva Tex and a duel?
Yes, there are three examples. We had launched Gabapentin first prior to a protects valacyclovir and tetrabenazine.
I'm sorry, it's in what period of time are we talking about you
Okay, in Gabapentin was 2001. valacyclovir was 22,008 and tetrabenazine was 2013.
One of those are in the relevant period.
Just as in this is Mr. Klem apologizing for interrupting and apologizing for not being on the screen and not tired with a tie. But the both of the experts rely upon a paper and a publication refers to all sorts of other molecules over all.
Just a minute mystically, perhaps mainstream and we should excuse you again.
Oh, okay. Thank you.
He's now in a waiting room.
Sorry, sorry. Justin said I didn't I think it's because of you really get into good matter, but I apologize. All I want to say is that I have to cross examine a witness on other drugs and other time periods because he's led to evidence in which he provides a model based on other drugs and other time periods. And that's what's in that model. And I think, and I know you've you've ruled you had a preliminary ruling, but it will be very difficult for us to deal with this. If you don't hear the evidence. One thing pre press not to persuade you of its relevance at the end of the day, but to have the evidence not go in from the get go. And then to go into a cross examination of their witness where I can't put facts to him is highly prejudicial to us and I'm just, I speak now and I because I think this is the only point to raise it with, you
know, it's an appropriate point to raise it Mr. CLI.
This is and if I may respond to that, please. In general, there are two ways that the damages in Section Eight damages cases are are calculated. One is to use analogues to compare to them how this drug would have acted in the market. And another way is to use models, which is the way that both of the experts in this case did in fact put in their expert reports. They did not use the data from other drugs they use the data from zolpidem and use the model from a paper based on yes, many drugs but certainly no evidence of these drugs specifically. And for that reason. This it's just it's neither here nor there that these drugs that are outside of the relevant time period should be should be discussed.
Just a brief response, the reasonableness of the result of the two competing models will have to be assessed by the court and part of assessing that will be considering the proposition being put forward by my friend that after six weeks or eight weeks Apotex takes 80% of the market as a second entrant, which is not borne out and that's what will put to the expert based on other examples that my friends have had full discovery on and which are included within the group of molecules upon which that paper is based. That paper that they rely upon is based on other molecules for other time periods.
Just to say we have no evidence that that's what the model is, is based on and they are what they are,
and that's the issue justice and because you haven't heard the testimony of the experts yet, and so I'd say it's premature to rule on admissibility on relevance before you'd had the benefit of the chiefs and the cross examinations of the experts.
Just as we did actually ask our friends for the data that underlie the IGF paper that both experts relied on and we were told that they did not have access to that data, so they can't now say that that data included the information related to these drugs, when we didn't have an ability to to confirm or deny that.
Dr. Paul Bruton dores is the co author of that paper. The citation in the paper itself identifies the drugs which were looked at. So I can't believe my friend is suggesting that they don't know that it was based on other drugs. For other time periods when I believe she said that at the beginning of her submissions.
Can you explain to me a game mystically, why you need this evidence to be able to cross examine their expert?
Well, I'll tell you and it's only because I don't I think it's inescapable on cross examination by friend is proposing through their expert, a scenario which is unreasonable. And that's one of the tests upon which you assess a model is not just how it's built or what the principles are, but what the result is. And the result has Apotex. Frankly trouncing farmer science, even though it is five to six weeks behind farmer science in the real world, and we had that example of I believe it was valacyclovir with farmer science with a one month Headstart trounces Apotex at an earlier time when farmer science was smaller. So if at the end of the day you're left with the conundrum of how can it be that when pharma science is first it does so poorly? I would like to see if that that result that's the function of the of the model used by Dr. Bruton doors is reasonable, and you need to assess it against real world facts. They may not persuade you, you may find that they get little wait because they're earlier time periods or later time periods. But the fact that they have given you such a stark result from their model is something I need to cross examined upon and I need to do it with facts. And I don't want to have my friends experts say I don't recall. I don't see that. I don't recognize that IMS data.
Just as in if that was their intention. They could have had their expert originally draft a report in that way and they chose not to they use the model that's in the paper that both experts relied on and both experts wrote. It's not needed for cross examination of ours.
Just as in what we put in our expert reports doesn't constrain the way we conduct a cross examination.
We're gonna take an early lunch will resume at noon. Thank you.
And we instruct
Justin would you be able to let
stands adjourned until noon 12 o'clock recording stopped the stream and so finally we're going to be breaking for lunch. Early so you can return around
noon at noon. Okay.
Normally,
do I stay logged in or should I log off?
Please stay logged in.
Okay.
i Mr. Justice in is now out of the room. But normally it would remind you that you're still under oath and you're not to speak to anyone else about your testimony.
Okay. Okay, excellent. Thank you very much. So I'll be back in like five to 12 just to make sure that I'm that I'm all set. That should be perfect.
I'll log back in. Well, I'll be logged in but I'll reappear on the screen at that moment.
