Pharmascience Inc. v. Meda AB et al - Nov 15, 2021 - Part 4

6:19PM Nov 15, 2021

Speakers:

Keywords:

noc

generics

goodman

product

correct

launch

pharma

customers

fair

science

period

competitors

market

sherman

register

fact

investment

sell

monitor

aware

Beans be are Mr. Clean and I'll be there if you're there ah there Yeah. Okay. I just want to make sure Mr. Goodman was gonna be joining us again he seems to have disconnected from the during lunchtime.

Oh, I'm sure he well he got the day he got the timing. Yeah, okay. I haven't spoken to him that's not supposed to but you got the time Okay, I'll

try maybe writing emails Thank you Mr. Goodman. Are you ready to proceed? Just got in as well. I guess I am. Yes,

I had an issue clicking two buttons but I'm good to go. Now. Thank you Mr just isn't ready can resume. Yes. recording in progress. Court has now resumed

Mr. Scalia.

Yes, thank you justice. Hello, Dr. Goodman. Good afternoon,

afternoon.

So this like gonna repeat what we heard about this morning but just to confirm your you are the CEO of pharma science, correct? Yes. And you have been at the company for a little less than 30 years Correct? Yes, give or take and CEO for about half that time that?

Yes.

Okay. And that fair to say that one of the things you are part of your job, one of the things you're aware of in your job is what your generic competitors are doing other companies in this space?

Yes.

So for example, you were talking about the decision making process for pursuing a molecule one of the things you are aware of is what other generics are already in a market. That pharma science wants to join. Right.

That's to the we know who's out on the market, we don't know always who's going to be out in the future market.

Right, right. So you can see so fair to say that most of the markets you're most interested in are ones where there are no other generics.

I would you know, save and accept opportunities when there's a supply shortage or other factors. existing products are still important to us. They are still the majority of the things we sell. But when we're looking for new products, the ones that are the most attractive are the ones where we can be first

what right where, where there are no other generics already on that mark? Yes. And when you were considering the product at issue in this case, zolpidem, zolpidem ODT tablets anyways, so generic for southern oxes. The case was that there weren't any generics at that time. Correct.

We weren't there were no generics on the market when we made the decision to start developing. Right.

And so, as that process moves forward, is it fair to say that that you keep an eye on the market to see if that changes whether there are generics that launch

to the best of our ability we do so

and so that includes monitoring the NOC Health Canada and I'll see database Yes.

Amongst others, yes. Yeah.

Looking for cases under the NOC regulations, yes.

Yes, you making me go back to 2002 1011. And, you know, today I rely on that database is given to me from our trade. Association. I don't know if they're part of our trade association back then. I can't tell you how we monitored it, or how well we would have monitored it. Uh, when we made the decision to start developing this product.

I see but you would have part of the analysis is for zolpidem specifically was first, it was a innovator only market at that point. Yes. Yes. And two, you weren't aware of any other generics who had done anything to begin the process. Of genericized ation, correct. Correct. Okay. And so at and again, in respect of the zolpidem products, specifically, when pharma science filed its submission for its product there was a patent on the register correct.

When we filed our products for submission, there was not a patent on the register.

If there hadn't been a patent on the register, you wouldn't have had to navigate the regulations, though. Correct. If they're at that time.

Well, we had we submitted when we submitted there was no patent on the register. The patent on the register came up rate before we were expecting our approval of products. That is one reason why, you know, one way to know if somebody is out or good lead if somebody else is going to launch or out developing the product or planning to launch is to look at the patent register of cases that have been started. But if there wasn't a product, a patent listed on the on the patent register, there would have been no public cases of a competitor launching

right. And so, but you do know that a notice of allegation was sent by farmer science to the defendants with respect to zolpidem at some point. Yes.

We were obliged to do so because if we wanted our submission our NOC to be granted. We had to do so.

Yeah, I was just making sure that you knew it would that that had happened, that's all.

Okay, well, the way you're portraying it seems. These are established facts. So

okay. Yeah, well, it's making sure we're on the same page for that. So at the time, you sent that notice of allegation, and as far as you knew firmus science might be first to market with its product right.

Um,

when we sent when we sent that one, which was in December, I think Apotex had already gotten their noc. So it was around I mean, I would say if if you can tell me the facts, I'll verify them but if you're gonna ask me to remember every fact that I I'm not so sure. I prefer to give you the right answer if you give me the right facts or just straight facts, but I believe Apotex did not have to, as I remember Apotex did not have to submit in a way because they got their approval before the patent was registered. Before the patent was put on the register, I see I unfortunately, I unfortunately got my I unfortunately, did not get my NOC before the patent was registered. So I had to file an Inoue.

And if I may say, the brand did not have a son, my aunt, the brand or your client having seen my NOAA did not also have to start a court proceeding against us.

So if I understand Dr. Goodman. Well, let me back up. And so I believe it's in the evidence will be that and may even be admitted. I don't remember that Apotex is notice of compliance was received December 31 2014. Does that sound right to you? I know it was in December of 2014. Yeah, yeah. And then add Oh, I'm so so right. So then when when the defendants started an LC application against farmer signs you already knew that Apotex had, its NOC for its product correct.

It became it became public. And remember there's a date for filing in NOC and in a way until you get sued. I think it was around 40 Something days.

Right. So in in that 40 Something day period, you became aware that Apotex had an LLC for its product, but you didn't know what the defendants would do with respect to your product, correct.

I, when we filed our Inoue, we didn't know what the brand would do whether they would sue us or they would,

right but I'm adding to that that in that time period within that 45 day time period. You also discovered the existence of the Apotex notice of compliance correct

if the there again I prefer you to just look I'll accept what the record says it's public. When the NOC comes on the Health Canada register, assume us to know what the same day it came out.

So it's the same day or very shortly thereafter, you're keeping an eye on it.

Yes, we monitor it. Okay.

And so at that point, regardless of what happened with the NOC application, whether it got started or not, you knew you weren't going to be alone on the market anymore, right? You weren't going to get the home run that you talked about this morning.

No, I I don't even when you see an NOC get published, you don't know if Apotex would have had any quality problems, any material problems with their product. Again, sometimes it happens that people get an NOC and they cannot they're not in a position to launch. So I think that's a I don't think that's a fair, a fair and an always true conclusion.

Well, but Dr. Goodman, just to be clear, you're not aware of any reason why Apotex would not have been able to launch as it did, in fact, in 2015 Right.

I cannot remember today. That was. That was facts. I can only remember today about, you know what judgment we would make in the situations and hope I'm explaining it properly.

Well, your assumption would be that Apotex would launch its product if it could, correct. If

it could, it would. Again, I don't know Apotex his formulation. I don't know if it was infringing or not infringing. I don't know anything about that. So assuming they had a non they were in the same situation as me that they had a non infringing formulation. They would launch because that's how you make money in this business. Right.

And pharma science and and was familiar with seeing Apotex launch products in the past in general? Correct? Correct. And I assume it's true, Dr. Goodman, so let me know if it's not that you would have also been monitoring either through IMS data or through pharmacies to see if Apotex did in fact, launch started selling his product right. So there's open a product.

Yes, we will try to keep in touch with and monitor the situation

and one way to do that would be through your customers who are also Apotex as customers right.

Customers would be a better source for real time information than IMS because IMS is a lagging is a lagging report of activities.

Right. But just to be clear that the answer is yes that your customers are a source of information as to when other generics are selling their products. Yes.

customers. Our customers are the best source and again, they're always the best source of information when they tell you that they've actually bought and received goods from somebody versus telling them that they've been pitched an opportunity from from a competitor. Right again, some of our competitors pitch things that they cannot supply.

Right and but you do know from what happened in 2015 2016, that Apotex did in fact, sell its opening product in those years right That's correct. And then in 2016 2017 2018, after firma science came to market, Apotex continued to sell its OpenAM product, right?

Yes, they did. And we wish we would have sold alongside of them. You know, when our NOC was granted if that was going to be the case that we sold those alongside them, that's what it would be. We'd prefer that to be by ourselves, but if it was alongside them, that's what it would be.

And you you would have done that. Even if, even if in this part four world you'd seen them there No, see, that wouldn't have slowed you down fair.

I made a big investment in the development of this project. I don't sell I don't get a return

and to be fair, Apotex is in the same position, your assumption would be, they'll sell if they can, too, right.

It's logical, isn't it?

So you agree? Yes. And to be clear pharma science and Apotex are totally separate companies, right? You don't. You're not related. You don't have ownership stake in each other, anything like that correct. That's very true. And so you don't have the ability to prevent Apotex from launching its product and they don't have the ability to prevent you from launching yours, right. That's correct. Your true competitors in the generic market? Correct.

Yes, that's correct.

And pharma science and Apotex compete across a wide range of products within your portfolio. It's correct. Correct. And Apotex is larger well at the relevant time in 2014 to 2018 Apotex. was larger than pharma science. Yes. That's correct. They're they were the largest generic drug company in Canada. Yes.

I think they've been the largest in Canada's since I think the late 80s

and in the 2014 to 2018 time period, the second largest generic in Canada's Teva, Canada that right? Probably

would have been them or mud they're the most likely person to be second ranked.

Okay. And then Milan or Sandoz, number three, number three. At that time

I wouldn't I couldn't be one of those two. Don't ask me to place them in order.

Right. Fair enough. And then pharma sciences somewhere in the around fourth largest give or take and that time period. In Canada,

we floated let's say over the period of time we floated in being anywhere from number three to number five.

Air Apotex at that time was known to be a tough competitor is that fair?

No. Have you ever met Barry Sherman?

Take that as a yes.

Yes.

Yes. All right. Yeah, in fact, we were we were looking at an article from Dr. Around the time of Dr. Sherman's untimely death that had a quote from your father in it about what a tough competitor Dr. Sherman had been. Do you recall that?

I know at a funeral we said very nice things about people who are no longer amongst us.

fierce competitor would have been what Dr. Sherman would have been wanted to remember as is that fair?

Definitely.

Want to turn for a second Dr. Goodman to the issue of

cause customer investment is what sometimes called trade spend. Do you are you familiar with the customer investment practices that farmer science in the 2014 to 2018 time period?

I'm not familiar with them. I'm not familiar with them to maybe the detail that you're asking for. So if you specify that so I answer that question to you. But in general, you know, trade spend is something that we do. It's changed over a period of time, different provinces that put in different legislation, so I really can't give you an accurate answer. But trade spend is part of our business. If so, if you're looking for that type of acknowledgement, I give that to you. But I can't give you more details. Off the top of

my head. Okay. Well, so I don't think I'll get into the specific numbers for this particular product with you. I think there are other witnesses who probably are closer to the ground on that. And the one question I did want to ask you was whether you were aware that in terms of the timing of payment of customer investment to so let me back up for a second. So customer investment or trade spend is amounts that farmers science provides to its customers pharmacies. I think I'm frozen. No, no, you're not frozen. No, you're fine. I can't see Dr. Goodman anymore.

I can't see. Goodman neither.

I can but he appears to be frozen.

That so I couldn't tell. It's out there. Okay, great. Sorry, doctor. Good. Maybe we lost you there for a second. Actually. I

thought I lost you.

I think it might have been mutual.

Can you hear me okay? Yes, I do.

You're a little bit fuzzy at my end, but I can hear you and I think that's what matters for the purposes of the transcript. So I let me go back a second because I don't know where where we lost the train of thought. So I was asking you about customer investment. And I was saying that that in general customer investment is a mount that in the context of pharmacy and specifically as amounts that pharmacy science provides to its customers in relation to sales of pharmacists products that those customers make.

Correct.

And so, but as we understand it, most of the most of this distribution of pharmacy sciences products isn't directly to pharmacies, but it goes through wholesalers, is that right?

That's correct.

And as we also understand that that results in a bit of a delay between when the sale is recorded and when the customer investment is paid out. Are you familiar with that?

Yes.

And that delay is in the order of a few months, is that fair?

That depends on how quickly things can get processed and the information at the time. So it's not again, I can't can answer that question for this period, you know, for any specific period. Okay.

So you know, it is a thing that exists but you're just not sure exactly how long it would have been in this time period. For this drug. Correct?

Correct.

Okay. Go back for a second to January of 2015 and the and the Zopa and market in the but for world so, we're back in January 2015. And a spot for world with me so far.

The bud for world is means that I will not that valiant has not started an action against us.

Correct? Yeah, can't in fact, can't do that. Okay. So or chose not to? Yeah, either way. It doesn't happen. Okay. And so you accept that in January and February of 2015. Apotex has its NOC for its product and further science in this scenario has its NOC for its product, correct? Yes. And in that scenario, where you're in direct competition with Apotex is it fair to say that both companies would have moved as quickly as they could to get their product from NOC to market to shelf

that's very Yes, I agree with that.

And so it's not so much a home run anymore for pharma science. Anyways, it's more of a foot race.

All depends how prepared Apotex. My competitor is right at the time and again you know, they may have had delays in all kinds of different ways, and I'm not familiar with what those could be right now.

Right? You're not aware of any you're just saying it is. It could have been possible. Right? But you're not actually aware of any reason.

I'm not an expert. I'm not saying I'm an expert of my competitors launch readiness in 2015. For their product

for them. Yeah, I'm not looking for an opinion. I'm looking for your personal knowledge you're not personally aware of any reason why in the bud for world. Apotex would be any slower to get to market than it was in the real world, right?

Correct.

Okay, just as in can we have just five minutes set here? You mean? Thank you.

Agenda until 202

recording stopped recording in progress. Thank you, Mr. Stone. Yes, thank you. Justice. And those are my questions for you. Dr. Goodman, thank you for your time.

Nothing. Thank you very much. Thank you, Dr. Goodman. For me. I'd say you can stand down but I'm not quite sure that's appropriate in the Zoom media but you can you can disengage I suppose. Thank you very much. Thank you very much. That's it for today as I understand it from the schedule. That's correct. is distinctly Can I just raise with you? A small perhaps housekeeping matter? At least the copy of the hauless reply report, the redacted one that I was sent, does not have the schedules attached to it that he makes reference to.

Oh, okay, so we can deal with that. I didn't think you would need them to be reset, but we can resend it as a package with the with the jails with

all of the schedules are right now. We'll

have to start that out. But I believe we'll get that sorted out. We'll get it to you.

Okay, that's fine. Thank you very much. So we'll stand adjourned. Then. Till 930 tomorrow morning.

Thank you justice.

Both

stands adjourned until 930 Tomorrow morning in November. 16th. recording stopped