Pharmascience Inc. v. Meda AB et al - Nov 15, 2021 - Part 3

4:27PM Nov 15, 2021

Speakers:

Keywords:

goodman

launch

friends

risk

position

pharma

drugs

witness

products

transcript

evidence

issue

decision

motion

case

science

deal

question

argued

transcription

Okay, now I'm just doing this as a test I will talk for a few seconds to see if anything appears

this is Shawn. The coordinator good belief that I sent out by email will be updated in about a minute with the

public and will be differently Spiegelman's having an issue connecting I can send him the link again if you can't find it

or something like that

I'm making crazy find out

the website has not been updated and should be able to click on Like cats to feed and see the new links and the previous link for the old text is also available.

I'm gonna bias justice. Saying that the witnesses joint the gentle live transcription has been corrected. It's it's working. Now. We did a test when everything's okay. However we are waiting for the witness to join us

for tradition My understanding is that he's joining I just haven't seen him yet.

I haven't gotten the word that views anyone. Oh, there you go.

So the recording is working now.

Yes. If you click on the same link, it should. It shouldn't you should see what was said earlier during the break. It is ready to resume

and so where am I supposed to be seeing this on this transcript? Um,

when you click on the link, Mr. Justice and you might need to reload the page actually, because it created a it started a new transcription now because it had been disconnected. So if you go back and the email I sent you, with the link you click on that should bring you to the new one.

minute here my. Good morning. Meanwhile to find the link

is for all the emails this morning

or for the course. Did you get my last email?

Sorry, I was talking to a party that didn't get a chance to

read it. That's fine. That's what I'm asking. So you're right. There's no confidentiality order. Anything that's marked confidential now in the email to get just leave it as it is. If it's made an exhibit and take that Expo to the confidential so you know why are we doing why are we hearing this? This is our conversation first thing this morning.

Yeah, we must be playing it over again. For some reason. I'm not sure why. Okay, we'll take a look

at so much going on here with the live transcript. file and I made you another couple of screens. It's

it's So okay, so Yeah, might be nice. I don't know if they make a request it that seems to silence

me that

limited space here. Wait a minute. Wait. This was our conversation this morning. Why am I hearing this?

And desire we even perhaps the transcription live transcription is maybe just I don't know otherwise how you would be hearing it. The Zoom recording has been paused. It's not ongoing.

Just to sit here getting a bit of this before the break as well. I don't understand it either. But it is rather disconcerting.

Can I ask you, Mr. Justice, then just to close the Livestream transcription just to see if that's where it's coming. From. transcribing the meetings between the registry officer and justice in the council as president. I believe that should be off record. That's not

just one

click on the text I'm sorry to interrupt. So if I understand correctly, you're seeing the text happening live right now. Backing off the record matters. Is that what you're you're you're concerned about

just yeah, we're trying we're hearing recording from earlier at the beginning of the hearing around nine o'clock. This morning. 915 we're just hearing the audio

Okay, right now the that if you clicking on the me P click on live transcript up that's the current one right now.

Is it possible that the expedient audio playback as well?

It will do an audio playback if you click on previous live transcripts if you click on November 15 20.1, part one that's from the the this morning.

Pretty good audio it will just show the transcript

and it'll have audio and the text after the fact so I recommend you refresh the page so that you can click on live transcription to get the lighting now. There won't be the audio when it's light when there's a light.

I understand that was probably my doing. I put my mouse over the transcript page and apparently it started playing back.

Right I think what's happening is you're probably gonna need to refresh that page to get the updated. It's the same layout but it got updated to a new layer which is the live feed for for what you see now.

Okay, well, we

seem to have solved the problem.

So Okay, wonderful.

Let me know if you need any more help. My apologies still

fine. Okay. We are getting used to this. You seem

to be ready to go recording in progress.

You've not resumed Good morning, Mr. Goodman. You doing well?

Yes. Good morning.

Thank you audios good videos. Good. Are you ready to be sworn in? Yes, absolutely. I have noted here they've chosen to make an oath on the Bible. Is that correct?

No, it was to be affirmed, I believe.

A solemn affirmation. Okay, perfect. No problem. All right. And that case, I'll ask you to please state your name, occupation and professional address.

Eva Goodman. My profession executive my address 631 Carleton Avenue Montreal Quebec.

Professional address actually I have

professional address from a science the address is 6111 Royal mount Avenue, Montreal, Quebec.

You solemnly affirm that the evidence to be given to you by you to the court shall be the truth, the whole truth and nothing but the truth please say I do.

I do.

Thank you. We're ready to proceed. I don't see my friend though. I would prefer to have them to know that they're around. There is

yeah, I'm here. I'll go off. If I come on. It's the equivalent of me standing up. I think if that's your preference, justice, and I can mean I can say on video, but normally I would come off.

I'm happy to have you there if you want to make an objection. As we all learned in public school, raise your hand.

Okay. So Good morning, Dr. Goodman.

Morning.

Are you alone in the room? Yes, I am. And do you have any papers or other documents in front of you? None. No,

I don't have any.

Thank you. Now, what's your current position? Dr. Goodman.

I'm the CEO of pharma science. And how long have you held that position? Since 2006?

And how long have you been with pharma science?

Since 1992?

Briefly describe your educational background for the benefit of the court.

They have a Bachelor's of Petra of commerce and a PhD in pharmacology.

And what was your first position with pharmacy science starting in 1992.

It was in research development.

And after that, where did you move?

I moved into business development

and what were your responsibilities in business development?

To find more commercial partners for us to market our products work look at the opportunities for pharma sciences grow through portfolio expansion, which meant looking for new molecules to develop and finding the commercial partners in which to support us and that like raw material suppliers. It involves making decisions for launching the products and early in that phase of my career, starting our international division.

And when Where did you move after that role?

I then became the Executive Vice President of firm science

and then with that.

Think around 1999 or so.

And what were your responsible responsibilities as executive vice president?

They were more of the same at that point. It became more of a responsibility for me to take a bigger role. In the portfolio selection decision to launch products at point I became the role that I still have today as the person who makes the decision to launch products. It involved a bigger role that our International has expanded quite a bit and that took up also quite a bit of my responsibilities that came along with that. Promotion.

You told me just a little bit ago that you became CEO in 2006. What uh, how was your responsibilities changed since you became CEO?

I think more like you would expect I ended up having more direct reports and more responsibility for finance quality operations and would report up to me so I kept quite a I kept my hand in some of the things that I was good at. They taught me that new role, but I ended up with more responsibilities that came along with more people.

Can you provide the court with an understanding of your activities, community activities outside your role as CEO farmer science?

I'm a member of the board of the Goodman Cancer Research Institute at McGill. Also on the President's Advisory Board of the Jewish Cheryl hospital, and I've just recently stepped down as a multiple board member at Sonne trade connect.

And now just to switch topics start to Goodman, can you explain for the court what it means for Generic Pharmaceutical companies to launch at risk as the phrase goes?

It means that when we launched the product, we know that there's a chance that somebody else will sue us.

When you give me an example, from early in your career of a product, the pharma SAS is launched at risk.

Gabapentin is one that comes to mind. It's one that we launched in 2001.

Mr. Goodman, we have an objection here from counsel.

Yeah. So you will have got the preview of this objection earlier. In the opening it unless Mr. stainsby I mean, his questions seem to seek this answer. So unless he's going to withdraw it, I think I'd prefer that Dr. Goodman be removed from the room and we discussed this issue more broadly.

I'm not going to withdraw the question so perhaps the court could put Mr. Goodman into a waiting room for the balance of this discussion.

Thank you.

So as you know, just as in AD and emotion argued two weeks ago and their written materials leading up to that motion, and in your decision as only one business day ago, but in particular, in respect of the positions taken by my friends in amending their witness list, and in that motion, they made it very clear that this case was only about zolpidem and only during the period in question, and I'll ask Miss Torrance to pull up the responding written representations of my friends at paragraph 13 and 14, let me know when that screen has been shared on it, okay, so let's just as soon as from the motion record of my friends in response to our motion for prior production, pages three and four of their written argument at paragraph 13. Is a very clear position being taken. The President action is concerned only with sales of the drugs open them and only during the period from January 2015 to December 2016. That paragraph 14, they identify that they have some witnesses at trial in paragraph 15. They excerpted from their amended witness list and we'll say and they've the bolding is in the original that is not our bolding that was in the original that and I think we've dealt with item A already Doctor Goodmans background and work history at pharmacy so that's fine. But B and C in my respectful submission in responding to that motion, my friends made it very clear to us and very clear to you that you weren't going to hear any evidence from these witnesses about anything other than zolpidem during the relevant time period. And in fact, in the original witness list, Dr. Goodman's evidence did include zolpidem and other products but they deleted that from there. We'll say so that they could take this position in this case, and so, you know, the written representations are, are replete with references to the fact that other drugs that other times are irrelevant. I'll I'll take you to paragraph 51 of my friends written representations at page 13. I'm going to take you in every one because it's throughout the materials and you heard the motion two weeks ago. It's not as though there's any question but if we see paragraph 51, and here they're talking about making representations as to why expert reports from other cases wouldn't be producible and aren't relevant. And the lack of relevance of information about other drugs and other time periods was the basis for your decision. And they said 51 the reports of prima facie irrelevant the present action is concerned only with sales of the drug has opened them and only during a period from January 2015 to December 2016. And then they say this PMS for gambling thing was a different time period and a different drug. And so my friends question, can you give us examples of other drugs from other time periods that are relevant to this case, and my respectful submission cuts directly against the position that they took a position that you relied on in rendering your order, and having taken a position a strong and unequivocal position, having induced the court's reliance on that position in terms of what the subject matter of these witnesses evidence at trial would be? It does not it is not appropriate and not possible for my friends to now leave the evidence that we said they might leave and they said they wouldn't lead and therefore we didn't need to see the other transcripts. So I said it in respect of the opening. I'm going to say it now again. And this issue with respect to these witnesses, and this trial is res judicata. They we argued it, they argued it you've decided and they're also a stopped from arguing now that information about other drugs from other time periods is relevant. How can they argue that so my objection is both relevance and Reza judicata there. There's no basis upon which they can now leave this evidence having having taken a position that they did in respect to that prior motion and my respectful submission. So the question is in proper, that's the nature of my objection, and I've asked that the witness be directed not to answer.

Let's do stainsby

Yes, my friend made repeated references in his opening to reliance on real world events to inform the construct of the but for world the motion that was before you had nothing to do with my clients willingness to launch at risk, the motion that my friend brought sought, detailed evidence as to trade spanned rates and costs of goods sold and those kinds of things with respect to other products at other times. The willingness of farmer science to launch at risk is obviously a critical element. of this case. My client will be severely prejudiced if he's not entitled. Mr. Goodman is not entitled to talk about prior instances where it has launched at risk. We're not going into details. We're not looking at the cost of goods. We're not looking at tradesmen, we're just generally talking about the fact that farmer science has launched products at risk, which is always an issue in a section eight case. And it's always been the case that the court has allowed the evidence. There can be no res judicata on my clients willingness to lodge at risk because that issue has not been adjudicated, and estoppel. I don't see how that arises here either. The the point of focusing on the differences between zolpidem and pregabalin in response to the motion was that the detailed information my friend was seeking with respect to gambling could have no bearing on what had to be decided in this case that had nothing to do with the general concept of whether pharma science was willing to accept risk on launching products. So I think the objection is ill founded and and a flies in the face of my friends repeated reference to relying on real world facts and history to inform the decision making in this case

like that, let's just go

only to say that I didn't hear my friend parse the issues that carefully two weeks ago, and nor is it parsed that carefully in their motion materials, the the unequivocal statements of church materials. There, they were unequivocal and they were unequivocal at trial. And so there's the the real world of zolpidem is what we plan to defend this case based on your decision and they're represented

sorry frozen

back on that is not a respectful submission. I'm not gonna repeat.

Oh, hey, Mr. Snowden, you you froze for I don't know 30 seconds or so. And just came back on now.

So I don't know what where I was going i i suppose my my point to summarize was that what my friends appear to be doing is cherry picking which issues they think they can lead evidence on which they can't, but in my respectful submission, their position, and your decision was that this case is about zolpidem and zolpidem related things and not about other drugs from other times, having a having obtained that ruling and they need to live with that. As do we for the for the duration of this trial. So there's there's time. Frankly, I'm surprised that they would try this but at least it's early we can get this dealt with and out of the way now.

Is Is there a question Mr. Snowden from your stand as to whether or not the plaintiff would have launched Zocor them at risk?

I mean, is that even an issue?

Is this an issue?

Not really.

So my friends my friends willing to concede that pharma science would have launched at risk, then we don't need to do this. But respectfully, these issues. I mean, these drugs were discussed during discovery, and my friend is making some kind of representation to the court that they've never been discussed before. And that somehow he's prejudiced is ridiculous.

Is the agreement. Mr. Scotto, that farmer science would have launched this drug at risk? So

right is there agreement? Is there agreement on that? No, we haven't reached an agreement on that specific point. But I'm not going to have my friend do this. Say you know, you asked about these things on Discovery fine. We asked about them on Discovery. We wanted to know about them and we wanted the transcripts so that we could effectively cross examine this person and search for

a transcript and Gabapentin it's it's apples and oranges.

Gentlemen, one of the time please

the issue here. Justice in is that at is this issue in dispute? Not really. Have we reached a formal agreement on it? No. But the issue that my submission is that the issue that Dr. Goodman is entitled to talk about, based on the motion the positions they took in the amendments they made to their witness, listen, we'll say in order to get the ruling that they got from you is that he's free. To talk about pharma sciences willingness to want SOPA in the platform world, it's bolded. In their motion materials, it's the only they took out and other products from their witness list. My friends repeating himself version of the Blackline version of the witness was they took out and other products from their witness list to respond to the motion and now they're putting it back in after they got the result. They want it. That's our objection. And I'm not going to have my friends you know, creeping li get admissions or deal with issues this way. It's improper what they've done. They don't get to lead evidence about other witnesses they get about other drugs and other times they get to lead evidence about the things they said this case was about when they were talking when Mr. stainsby was making submissions to you two weeks ago. So it's not ridiculous or absurd on our part, it's it's incredibly cynical on the part of the plaintiff to get what they got and then to lead their case in opening and at 1155. On the Monday with evidence about other drugs from other time periods. That issue is determined in my respectful submission.

I'm not sure it's determined. I'm not sure that it's res judicata. I think its relevance is very questionable, quite frankly. And if in fact, and I haven't heard to the contrary, and I do have the will say statements somewhere. If in fact, the reference to this witness justifying about other drugs was removed from the will say statement, then you're you're bound by that, Mr. stainsby. And as I say, and you know, that the, the relevance of this evidence on other drugs, different time, different financial considerations.

But just as in there are a series of drugs where my client will testify that they launched at risk and it goes to the pattern of behavior, the internal ethos at the company and how they conduct their business, whether when they're coming to the decision whether to launch has opened them at risk. It's extremely relevant in that respect, because they've taken risks greater risks, in other cases, that zolpidem is not a very risky product, and why my friend won't just simply agree if he wants to take this position, that they my client would have watched it at risk when it had a non infringement position. And the sales are not high. I mean, I just don't understand it. I mean, this has been sort of the approach of my friend to everything in this case, they won't agree on anything. And so we've got this list. Of 10 Witnesses we have to call, for example, as Mr. Lee made made clear in opening we have to bring someone in to prove the IMS data I've never had to do that before. And so we're faced with at every turn, Mr. Skoda's objecting refusing to agree and just being a dog in the manger throughout. And frankly, it would as I said earlier, prejudice my client, if we were not able to establish there are a number of drugs, which they launched at risk over the course of the history of this company. And they would be would have been prepared to do that in this case. Because my friend won't agree

your liberty gotta ask him Mr. stainsby. If the company has launched previously at risk, and you're gonna ask him about this particular drug and why they made the decision to launch it at risk, but I don't want to hear anything about any other drugs. That's a relevant Well, if they have a corporate practice of doing so that's relevant.

Okay. I can deal with that. Thank you.

Susan. Can we get Mr. Goodman back?

I do just want to respond to the one comment from Mr. stainsby and Mr. Clay about the refusal to the IMS data. The IMS data relating to zolpidem is admitted. It was the IMS data relating all of these other drugs that we didn't admit because you determine that they weren't relevant. So we said we're not going to deal with so it's a bit my friend should be careful about who's raising what disputes with whom the relevant data that was used for the expert reports has been admitted. And as in the case, it's the it's the data about other drugs, that we are taking a consistent position that once it's out its out, so we don't need that. That's all.

Just to say I'm sorry for intervening. I know Mr. stainsby has the has the podium, but he probably doesn't realize or know because he hadn't dealt with this. They are actually objecting to zolpidem IMS data. Okay, so my friend has misrepresented the situation

from outside the time period. So the relevant data that the witnesses used, got the relevant data has been admitted. So you know, if they want to have other data about other drugs or other data about other time periods, no, it's not relevant. And so we didn't deal with it. We it anyways. i There are a number of disputes here you will have a sense justice in over the course of this as to

I hope there are fewer and fewer of them, quite frankly, me too. I appreciate that. We're arguing over one and a half million dollars plus some interest but as my children will tell you, I can lose my patients easily. So let's get Mr. Goodman back in finishes in chief. Thank you.

Welcome back, Dr. Goodman. Now, I'm going to ask you Dr. Goodman. What is pharma sciences general approach to the launch of generic pharmaceutical products in an at risk position in the Canadian market?

Well we at launch risk. We've started the idea of an app launch risk when we start on the possibility of an at launch risk starts when we think of developing the product from the get go. So So can you be more specific about wind

was started starting from there? I mean, what is your company's approach to accepting the risk involved in launching a product when you could be sued for patent infringement?

Well, we take we look at the the risks and the benefits when we anytime will look at launching a product at risk. But you know, we've size them up usually, very well before we when we started the development of the product because it doesn't make sense for us to ever develop a product. Knowing that there's patents outstanding, we're starting that development and not having an approach to deal with them.

And can you explain why sorry, how many how frequently has pharma science launched? At risk in the Canadian market?

dozens of times by now, we've been in business for 35 years now. 35 plus years.

Can you explain why farmer science is prepared to accept this amount of risk?

Well, that's a matter of why we're still in business for 35 plus years, because lunch, because coming out with products first to market is at the time when those products have the most value. They go with the highest selling prices. And if we're first the lowest amount of competition, so that's that's the best time to get the greatest opportunity. And furthermore, we also get the benefit of the for first launch or early to launch. The market share that we gained initially sticks with us usually for a long period of time. So it's critical that we our growth is critical about take about coming out to first to market and if coming out first a market requires us to take launch at risk position. We do it

now when I turn turn topics now, Dr. Goodman talk to you about the bat for world and the launch of zolpidem. At Risk Did you approve who approved zolpidem for development in 2011. I did. And what concerns if any did you have about patent infringement when you approves off of zolpidem for development?

Well, actually, we thought this one was a very low risk one because it was a formulation patent. And we you know, we purposely designed an approach that would be non infringing and we're talking about we developed this product, there wasn't a patent outstanding on the register. So we didn't even know if we would have to deal with it. But we did our research and looked at the product in other markets and designed a non infringing formulation. So since there wasn't anything on the patent register, and since we knew that we had the best possible position, coming up with a non infringing formulation, I have to say the risk was very, very small for us. That we would end up finding ourselves in a position to AV launching at risk.

Now ultimately, fire science did serve in NOAA with respect to zolpidem, can you explain how that came about?

That came about because a patent was issued on that a patent was issued. And maybe before we got our approval from Health Canada and the brand company listed on the patent register. And that obliged us to file it in a way if we wanted to get our notice. of compliance. Now,

before the patent game became came to be listed on the patent register, what were your intentions with respect to making the decision to instruct your team to launch zolpidem?

We were planning to launch as soon as we would get our approval.

And what would you have done? Dr. Goodman of pharma science had received its notice of compliance on January to 2015.

And this can you can buy for in the bud for world if we would have gotten our approval. And there was nothing on the register we would have launched. Okay.

And was there anyone else who's whose authority was required to be was required to launchers up or down at that time?

I mean, inside pharma science, yes, I do. I made that decision.

And what now let's just assume pharma science received its NFC honor shortly after January 2015. And no other generics appeared to be set to enter the market for zolpidem would pharmacists have launched?

That would have been that would have been a home run for us if we were the first one out before anybody else. Be a home run.

And would your answer be the same if on that date January to 2015? There was no court decision under the NOC regulations addressing the patent.

Certainly. Again, I come back and say this was a very low risk. This was a very if we look at at risk launches, this was the lowest form of at risk launch. I I've almost that I remember right now.

Now let's talk about the launch in the real world who made the decision to launch shares over them farmers PMF so put them in December 2016.

Same person myself

and what what when did you make that decision?

This soonest we were able to make that decision when we when we got our NOC as a result of winning our pm NOC proceeding.

All right, thank you, Dr. Goodman. Those are all the questions I have for you this morning.

Thank you very much. It's been after 12 I gather you're going to be a couple of hours in cross examination. This is golden.

Probably not actually, if we if we take the break now, given the ruling and the the issues that Mr. stainsby addressed. I actually don't think we'd save some space but I think I'll be substantially shorter than that. So provided that I have time to make it shorter by looking at my notes over lunch. So my suggestion, if it's amenable to you is that we take the lunch break now and then I am confident that I will be done by the afternoon break.

Okay, so we'll take lunch now it's 10 After 12 We'll take an hour and 20 minutes. Thank you very much. Oh and Mr. Goodman, you're still under oath and examination is finished but not cross examination. So you are not to discuss your testimony with anyone including pharma sciences, counsel, and you have another point, Mr. Scogan?

No, that's what I was going to ask before I sat down if we could do the you know, one question and consider himself to be on a cross examination but you've covered that so as long as he understands that, then I have nothing more to add. Thank you.

You have any questions on that instruction? Mr. Goodman?

well understood.

Thank you very much. Thank you. Great we're doing for our lunch break. Then. Thank you very much.

adjourned until 130 recording stopped