Pharmascience Inc. v. Meda AB et al - Nov 16, 2021 - Part 1
2:16PM Nov 16, 2021
Speakers:
Sean Prouse
MR. de SOUSA
JUSTICE ZINN
Keywords:
pharma
document
noc
launch
science
product
meeting
gate
exhibit
canada
api
project
patent
report
litigation
proceed
page
batches
farmer
validation
just doing an audio test check on future test check
they just sent the Debbie ship documents to you guys
thank you check one two, check one two. Check one two. Can you hear me now? Check one two check one, two. Okay we're good. Okay, we're on mute. Now. Good. Morning Justin.
How are you? Well how are you doing? You can hear me just fine. Excellent.
Thanks Purchase. By International. The link to the to the live transcription doesn't seem to be working.
I clicked on it and just to the new the new link of a sentence. I'll resend you to everyone just in case.
Yes I used a new one that was sent
infinite four.
Are the gemstones as I did last time again put everyone in the waiting room won't be too long. Justin you should have the link down it seems to be working I forgot my water
glass
ready to proceed?
Listen, they'll be speaking on behalf of the plaintiff. To start I will. Okay. The defendants ready to proceed
we are Thank you. recording in progress.
Good morning.
Good morning just for the record. Thank you. I've received the reply report with all of the schedules that go with it. So thank you
for that. You're welcome. Just a couple administrative things to start off with the first is the trial calendar which Mr. Cleaver referred to yesterday. Yes. And that was provided to my friends on Sunday and it's been uploaded as FC315 And just two small changes in that one versus the prior when you would have seen. The first is that on Thursday, Miss McCluskey and Mr. Soriano are reversed in order. And that's because Mr. Ko ski is in Alberta just on account of the time difference we'll have a second. Second is that Mr. Eric advance song has been added to Friday morning and he's the one that will speak for 15 minutes to address the IMS data, which my friends have not admitted authenticity of. And I'm not sure how long my friends proposed or crossed but we think Mr. Henson will be 15 minutes. Okay. And then the only other thing is that I can give you an update Iran are on Glenmark we have confirmation and I'd advise my friends this morning of this we have confirmation that Mr. suneet like Wani, will testify for Glenmark and so I provided that name to my friends along with his contact information. And Glen marks provided us with two new documents which I provided to my friends as well. And what we're proposing because he's in India, with the court's permission, we'll do a zoom testimony on 9am on Thursday if that's okay with the court
that's fine by me.
And we don't think it'll be any longer than 20 minutes or so.
And I would just note, I haven't had a chance to look at what was sent over this morning. We got it shortly before nine. So I'm just not going to take a position at the moment on the issue if that's all right.
No, that's quite all right. Understandable. There is any issue maybe you could hopefully there won't be any issue maybe you could let me know. Tomorrow.
understood and agreed will do so. Thank you.
Not faction crazy administrative issues just as then. So with that we would call Miss Betty ship. Witness
hear me?
Yes, now I can. Thanks.
You're doing well this morning. Yes, thank
you. Okay,
are you ready to be sworn in? Yes, I am. According to the information I have here you wanting to make a solemn affirmation. Is that correct?
That's correct. Okay, perfect.
As a result I can I ask you to please state your name, occupation and professional address please.
My name is Debbie ship. I'm retired. I'm acting as a consultant. I live at 32 floof apartment 906 in Verdun, Quebec, h four G three M seven.
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. And my man proceed. Good morning,
Misha. Good morning. Can you just confirm first that you're alone in the room and there's no documents in front of you? Yes,
that's correct.
What's your current position?
I'm retired. I'm acting as a consultant for for science.
And when did you retire from Pharmascience? In December
2016. What was your role when you retired? I was senior director of portfolio and project management.
And for how long before retiring? Did you hold that position?
From 2010 until December 2016.
And prior to that time, what was your position with pharma science?
I was senior director of portfolio management.
And can you just explain to the court what your responsibilities were in those two roles?
Yes, I was responsible for all processes related to selecting products into our portfolio. And then once the product was being added to our portfolio, the project management team reported it to me. The project manager was the person to oversee the project through development right up to launch
and what responsibilities if any, did you have in relation to commercial launch of a product?
We were responsible to bring in the product roadmap to launch which meant having the releasable quantity of products determined by the business unit in stock ready per the target launch date.
I'm just gonna switch topics and ask you about pharma science the company when did you first become employed with pharma science?
I started in 1987. I work there over 29 years.
And what is pharma sciences business?
They manufacture and sell pharmaceutical products both nationally and internationally.
And how many people are employed at pharma science? Roughly? Approximately 1500. And has that changed since 2015? To 2016?
It's about the same.
How many people were employed when you started at pharma science in 1987? We were around 50 employees when they started. The pharma science manufacturer it's active pharmaceutical ingredients
and no we do not we purchase it from API suppliers.
What about finished dosage forms?
We manufacture many of our own products. We take the API that we purchase and convert into finished goods.
Now, are you familiar with NFC proceedings? Yes, I am. And can you just briefly explain to the court your understanding of what those are?
These are court proceedings that address the validity of patents or patents or patents that are listed on the patent register in order to determine if the generic can get approval to sell in Canada. Okay, and what does NOC refer to? That's notice of compliance. That's the approval by Health Canada to sell in Canada.
Now, prior to 2011, what was the process at pharma science to select and develop a product?
If a particular product was identified as a potential candidate, we would bring it through two committees. The first committee was called PEC, which stood for product -- I’m just having a blank -- evaluation committee. And the second committee was PMEC, which is the portfolio management executive committee
and who were the members of those two committees.
Both of these committees were multidisciplinary teams. The PEC tended to be manager director level from different departments, and the PMEC was our executive committee. So our CEO or president and the VPs.
Did you attend any of those meetings? Yes, I actually chaired both those meetings.
And how was the decision made to pursue a product at those meetings.
My team would conduct an analysis using the input from for many different departments which we would present. At these meetings, we would use a template that we call the PATH. We have a lot of acronyms. It's a product evaluation form. We would complete this evaluation and present it to both committees.
And what type of information is included in this product evaluation form?
It has an overview of what's required to develop the product. It talks about the risks, the timing, the costs, the potential revenues information. Like that.
And once the decision was made at a meeting, such as the PMC meeting what would happen next?
I would assign a project manager and that person would kick off the project.
And at a high level, what are the steps from Project Approval up to commercial launch?
We would look at the IP considerations. We would order some API to do formulations. We would conduct analytical studies we would do a bioequivalence study, we would submit to Health Canada and then we would produce validation batches.
And was there a process at pharma science to share project updates along the way?
Yes, we had a gating process we have five major milestones or gates. The first I talked about was the pmec.The second gate was we called the P lot, production of pilot batches. The third gate is the Biosteady gate. The fourth gate is the Submission gate, and the fifth is the Commercial gate.
And do those steps happen in sequence or do they overlap?
The first four development gates happened in sequence but the last gate the validation, sorry, the commercial gate, which involved validation batches could overlap with the development kits.
And what's the general timeframe for steps from development up until launch? Or sorry, from development up until submission to Health Canada?
Hard to say every product was so different, it could be quite quick like 18 months or it could go for five years as well.
Okay. And then with respect to the IP considerations that you mentioned, what sort of steps would Pharmascience be required to take?
We would look at patents that are on or not on the patent register. If they're on the patent register, then we would have to submit an anyway sort of delivering in a way to the brand company
how would you estimate your launch date? If there were patents on the register?
We would target the successful resolution of the litigation.
And I understand there's two approaches to dealing with patents listed on the register one is to await expiry. The other is the challenge and if you were challenging, what sort of steps would you take?
We would -- we would deliver an NOA to the brand company as the first step.
And when would the NOA be served in relation to product development?
It depended on the product and the litigation strategy related to that product
And if Pharmascience obtained an NOC, a notice of compliance, when, in relation to obtaining the NOC, would it aim to launch its product?
or general goal was always to launch within 24 hours of receiving NOC
and how are you able to plan for the date that you will receive your NOC if there is an OC litigation?
We would target the successful review by Health Canada, our regulatory affairs department would monitor and advise us the expected completion of this mission view.
Okay, and if there was litigation ongoing, how would that impact whether you could launch upon completion of the review by Health Canada,
then we would target the resolution of the litigation, we would start using the 24 months stay period and work backwards.
Okay, thank you. Now I'm going to put some documents up on the screen and my colleague is here. And I believe you have a copy of these we'll use the share screen if you want us to move throughout the document just instruct us and we'll scroll throughout it. The first document I'm going to put out is pharma science production 132 which is FC 191. Can you see that on the screen in front of you? Midship Yes, okay. And do you recognize this document?
Yes, I do. This is that path for the product evaluation form that I talked about the analysis that was presented to the PC and the pmec Okay, for which product? This is I sorry, this is resulted in five and 10 milligram supplements. sublingual tablets. Okay. Thank
you. Justice, then can we mark that as the first exhibit the next exhibit?
Yes, I think it's exhibit five. Yes.
Thank you, and then we have what was this document used for?
This was the analysis that was presented at the P MEC to get approval to add this product to our pipeline,
and who created this document that farm science.
And my team created this document with the input from many different departments
and on the first page at the top, there's words that say pmec, date, July 12 2011. And what does that refer to?
This is the date that the actual pmec meeting occurred.
Okay, I'll turn to page eight of the document and there's a box near the bottom of that page, the words and percent of blue text June 23 2011, sent a P Mac for approval. Can you just explain what that signified?
Yes, the P ec meeting was held on June 23. And that committees recommended that we send this product two P MEC for approval.
Okay. And then what about the box below with the P MEC decision? What does that mean?
So then the P MEC meeting was held on July 12 2011, and it was approved to start developing zolpidem. Okay,
did you attend the pmec meeting? Yes, I chaired this meeting. Okay. Can we go to page three please? And there's a line that says PMS submission timeline. Do you see that? Yes, I do. And what does that refer to?
So at this point in time, we were projecting it would take 24 months from pmec. approval to submitting our MDS to Health Canada
and go to page seven please. And which department at pharma science was responsible for completing the information on this page?
This was completed by our IP department within Scientific Affairs.
Why did they conduct a review of the patents that are here?
It should know whether or not we would have to file an NOAA whether we if there was going to be litigation or not, and that would affect the launch date.
And then towards the bottom, there's a box that says preliminary review and strategy. And below that there's the words launch, and then there's an X in a box there. Can you just explain to the court what that refers to?
So since no, NOAA is required, we can launch upon Health Canada.
Okay, thank you. So we'll close that document and we'll turn up PMS production 71 which is FC 130. Do you recognize this document on the screen worship?
Yes, I do. This is the presentation that was used at the kickoff meeting led by the project manager.
Okay, thank you, just as in one mark that as the next exhibit
will be exhibit six.
And what's the kickoff meeting?
This is a meeting where we review the project scope and key activities with the department heads the key stakeholders in the development of the meeting of the sorry, the development of product.
And when was that meeting how that farmer science
August 11 2011. So roughly one month after the PMC meeting.
Okay, and I heard you say August 11. And where do we see Sorry,
August 18. Sorry, August 18 2011.
And what level employees attended this meeting?
It tended to be manager and director, excuse me of the various departments involved. So from the development team to marketing finance regulatory, many different departments.
Okay, go to page five, please. And there was a bullet there that says timeline, timelines. And can you just explain to the court what that refers to?
So at this point in time so we're for five weeks after the pmec were further evaluation has been done. They're projecting will take 31 months for pmec approval to be ready to submit the AMDs to Health Canada.
Okay, and then we'll go to the last page of the document, please. And can you just explain to the court what the dates are that we see here?
So these are the major steps required to be able to put together the NDS and the timelines associated with those major steps.
And at this point in 2011, when was Pharmascience expecting to be in a position to submit it struck submission to
Health Canada in April 2014.
Okay, thank you. We'll turn that we'll close that document and open up pharma science production 135, which is FC 194. And this one's a little smaller, so feel free to ask us to zoom if you need midship but my first question is Do you recognize this document?
I do this is this stage gate report for zolpidem prior to the pilot production gate.
Okay, can we mark that as the next exhibit justice?
Exhibit seven.
Thank you. Now what is the stage report?
This report is completed by that team prior to passing the particular gate in this case prior to passing the pilot gate. Okay, and when was this one prepared? It just make it a slightly bigger place. June 26. I just thought sorry, June 26 2013. And, sorry, the meeting was held June 26. So it's probably completed just prior to that.
Okay, thank you. And which gate was this report preparing for?
In advance of the pilot production gate, the gate where we produce the pilots get approval. To produce the pilot batches of zolpidem.
And please turn to page five of the document. And there's a heading there in the red box with the words pilot production final stage and then a heading that says at launch timing. Can you see that? Yes, they do. And what does that refer to?
So at this point in time, we are projecting that we will launch in April 2015.
I will call that document and open up Pharmascience production 136 which is FC 195. Do you recognize this document Miss ship?
Yes I do. This is the actual gate report presented at the pilot production gate for Zopa.
Okay, can we mark that as the next exhibit? It's exhibit eight. All right, and what the gate report
this is the report that's presented to the executive committee sharing the status of the project at that time and asking for approval to pass this gate in this case, the pilot production gate Okay. When was this report prepared? Meet was held July 15 2013. So would have been prepared just prior to that.
And what level of employees attended that meeting?
Myself, the project manager and the Executive Committee, which is the Vice President's the president, CEO or their delegates.
Okay. And was the decision made by the committee at this meeting?
Yes, they approved proceeding with the production of the pilot batches. Okay.
We'll close that document and I'll open up PMS. Pardon me farmer science. Production 139, which is FC 198. Do you recognize this document in the ship?
I do is the final stage report for zolpidem before passing the commercial gate.
Okay. And just to think we mark that as the next exhibit. That'll be exhibit nine. And when was this document created?
The meeting was held November 12 2013. So it would have been created just prior to that.
And on the first page under the heading project milestone, there's a line that says pm Comments. Can you just explain to the court what that signifies
there's two comments here one stating that the product is open M is a controlled substance. And it's also stating that the bio study is planned to be conducted in January 2014.
And what's a bio study
that's required by Health Canada to show the bioavailability of the generic versus the innovative product.
Okay, and then can you just explain to the court the dates we see below that comment for submission date and the projected NOC and the launch?
So at this point in time, we are projecting to submit to Health Canada may 29 2014. We're expecting our NOC at the end of March 2015. And to launch the product, the beginning of April 2015.
We can close that document and we'll open up pharma science production 141, which is FC 200. Do you recognize this document on the screen?
Yes, this is the actual gait report that was presented at the bio steady gait for as open up.
And just as we mark that as the next exhibit
exhibit 11 Oh sorry, exhibit 10. Myself.
What is the bio study gate?
This is where we are asking the gatekeepers for approval to conduct the bio study for zolpidem
and what which gate number is this in the list of the gates that I mentioned earlier?
This was the third gate.
And what was your role at this meeting?
I chaired this meeting. And when was the meeting held? The meeting was held December 9 2013.
And was the decision made at that meeting? Yes,
the gig here. Excuse me gatekeepers gave their approval to proceed with the bio study.
Okay, we'll turn to pharma science production 143 Next, which is FC 202. And you recognize this document.
I do. This is the gate report that was presented to the gatekeepers for the commercial gate. Zopa.
Okay and justice and can we mark that as exhibit 11?
This is Exhibit 11.
Thank you. And what gate number is this in the sequence? That you spoke of earlier?
This is the last gate but this is the one that I mentioned may not happen in sequence. So depending on the timeline for the project, it can happen in between one of the development gates
and what sort of decision is made at the commercial gate.
This is where we're asking for approval to either purchase API or to convert and produce finished goods and who attended this meeting. Again, this would have been myself, the project manager and the executive committee. And when was it held? The meeting was held February 3 2014.
And what was the status of the project at this point?
If you look, if you could just make it slightly bigger please. Thanks. So if you look on the project history and highlights it says that the bio study dosing had been performed. Analysis is underway.
And there's a line on page one that says above the yellow that says projected launch date and can you just explain what we see there?
Yes, so it's linked to the NOC date. So the NOC is expected March 30. And the launch dates for control drugs you require that the product beatitude narcotic license, you can only add a product to narcotic license once you have your noc. So it's estimated that will take five working days so that's why it's April 9 2015.
What decision was made regarding the zolpidem project at this commercial gate and if you can scroll down to the very bottom please. Little further
of a lag with Adobe
There we go. And so the decision that was taken is that we can place a P O for the API upon the successful bio study results.
Okay. And what quantity of API was pharma science planning to purchase at this
point? Yes, sorry. We'll have to scroll up to show that amount. He gets one page up. Maybe two. Little higher please. I think we missed it.
Right from page three. Marian. We'll start at the top of that one. I'll just give you a moment.
There we go there right there. So you can see the there's a quantity of 42.2 kilograms that's needed for launch. So that is what was approved to purchase 42.2 kilograms of SOAP API.
And when was farmer science going to seek delivery of that API?
You can see the very, very bottom of the screen may 2014.
Okay, do you know if a purchase order was placed?
Yes, it was placed once we receive the successful bio study results.
Okay. So we can close that document and we'll turn to pharma science production 145, which is FC 204. And you recognize this document and the ship?
Do this is the gate report that was presented to the gatekeepers at the submission gate for SOPA.
And can we mark that as the next exhibit just as then?
Yes, that's exhibit 12.
And may have left it in the ship but which gate was this one for?
Submission gate commission,
and what's the submission gate?
This is asking the gatekeepers for the approval to submit our MDS to Health Canada.
And when was that meeting held?
May 9 2014.
Did the executive committee approve the decision to submit to Health Canada? Yes, they did. And did farm assign submit the drug submission to Health Canada? Yes, we did. Oh, there's a line on the first page that says launch assumptions and we may need to zoom here but you let me know. Can you just explain the tax that's beside that heading launch assumptions?
Yes, I'll actually just because of the pictures with Zoom, I just need to scroll left a little bit. And thanks. So this is noting a change. A new patent was listed on the patent register. So we no longer will be able to launch at regulatory approval. We'll have to wait for these successful litigation of the MOC proceeding.
And when was that recognition made?
Somewhere between placing our P O in May and this port which was sorry, placing our P O in February and this report which is dated May I believe,
and why was pharma signed still submitting VA MDS? To Health Canada given that a patent was listed?
We still were planning to launch even if we had to litigate.
Okay, thank you. Now I'm going to turn up another document and justice then I'll I'll just let you know there's a couple of agreed facts relevant to this document. I'll just tell you what they are where where you can find them and then I'll ask them to ship some questions. They come from the agreed statement of facts paragraph 24 In paragraph 70. The first is that pharma science filed its ndS in respect of PMS, openend, five and 10 milligrams with the therapeutic Products Directorate. On May 28 2014. And then the second deals with the document I'm about to turn to and the agreed fact is that this document is a true copy of the letter that accompany pharma sciences and Ds in respect of zolpidem, tartrate, five and 10 milligrams when it was filed with the CBD and so I'll just turn that document up. It's pharma science production one, it's FC 60. And Miss ship, do you recognize this document?
Yes, I do. This is the cover letter for our ndS results.
Okay, and can we mark that as the next exhibit? Just as
we can, it'll be exhibit 13.
And how did that date the May 28. filing date line up with your estimated submission date when pharma science began was over them project in 2011?
It's actually quite close. We looked at the kickoff meeting from August 2011. In that kickoff meeting, we had projected April 2014. So we were within one month of the projection.
Okay, so we'll close that document and we'll pull up pharma science production to 01 which is FC 263. And you recognize this document?
Yes, I do. This was a report issued by regulatory affairs that showed this status of our submissions to Health Canada.
Okay, can we mark that as the next exhibit just doesn't
exhibit 14.
And is this document something that you saw at the time it was created?
Yes, you can see my name is actually on the distribution list.
Okay, and when was this document sent around?
It was sent in June 2014. So after our May 28 submission to Health Canada results
and at this point, when did pharmacy clients expect to have a completed review by Health Canada on the zolpidem submission?
They were estimating February 2015.
Okay, so we can close that document. And we'll open up Pharmascience production 202 which is FC 264. And I think I have that on the screen. Midship. Do you recognize that document?
Yes, I do. This is the same report issued one month later so issued in July 2014 by regulatory affairs, okay.
Can we mark that as the next exhibit justice and exhibit 15 And this was something you saw at the time it
was created. Yes, that was part of the distributions.
Okay. And when was this report provided or circulated within Farm science relative total. The last one we just looked at?
This was a monthly reports. So this would have been the next report after the one we looked at just before.
Okay, and we can close that document and we'll open up pharma science production 203, which is FC 265. And I've got a copy of that on the screen. Do you recognize that Miss ship?
Yes, I do. So this would have been the next report that was issued by them the following month in August 2014.
Okay, can we mark that as the next exhibit Jefferson?
Exhibit? 16. Can I just stop for a moment? Are these the last three documents are these pharma science created documents?
Yes, there are regulatory by our regulatory affairs department. Thank you.
And may have missed us miss ship, but when did you receive this document
in August 2014. So it was the following document that was issued after the July when we just looked at.
Okay. And as of August of 2014. When was pharma science expecting that Health Canada would complete its review of the zolpidem submission
in January 2015. Further tartar performance target date.
Okay, thanks. So, we'll close that document. I'll open up pharma science production 147 which is FC 206. And do you recognize this document in the ship?
Yeah, so this would be a subsequent commercial gate report for soap soap again,
okay. And when you say subsequent subsequent to when to watch
the previous commercial gate report we look at. Okay,
thank you. And why was there? Well, let's mark that as an exhibit justice in
exhibit 17.
And why was there a subsequent commercial gate meeting for zolpidem
projects often passed commercial gates multiple times either because of a change or a new decision that's needed to buy more API or convert more
product. And what prompted this commercial gate discussion.
If you could just make it a little bit bigger and scroll down please? Little further place everything is the launch date. Can you scroll to the right place in the project highlight section? I think it's here and
it's because I have photos from the Zoom meeting so I can't see what's on the right. There we go. So there was a this is a noting the change in launch date because of the litigation. So it's highlighting that and then if we scroll further down, as a result of this the validation schedule was pushed back as well.
Just coming up here. There you go. So you can see highlighted in yellow, the validation dates changed as a result of the new launch date.
And pharma time placed its order for zolpidem API by this point
we had but the reception date was delayed now it's December 2014. Okay.
Now I'll close that document and open up pharma science production two, which is FC 61. Injustice and there's two agreed facts relevant to this document. The first is in paragraph 18. Agreed statement of facts then paragraph 21st that farmer science served and NOAA dated December the 23rd on meta pharmaceuticals, addressing the 90 day patent, and that matter received it on around January 5. At that time, DNS and 988 patent was the only patent listed on the patent register. And then the second fact that meta AB Mehta pharmaceuticals Ltd Valley in Canada, and others commenced federal court application number t 200 Dash 15 On February the 12th 2015 against pharma science. And I'll just ask you midship. What impact did valiance litigation have on pharma science from a launch perspective?
It delayed our launch substantially from regulatory approval to successful litigation.
Okay, and the document I have on the screen I'll just flip to page three of that. And you recognize this document.
This is the cover letter for notice of allegation serve to the company.
Okay, can we mark that as the next exhibit just as
well it's exhibit 18.
And we'll scroll back up to page one. And can you just tell me when farmer sign sent this to the brand company?
We sent it December 24. Okay, now did
Health Canada ultimately approved pharma sciences open them and yes, yes, they did. And how did they communicate that to pharma science?
They sent us a letter of the effects.
Okay, I'm turning up pharma science production three, which is FC 62. And you recognize this document?
Yes, this is that that letter from Health Canada, advising us that at our file was we called it internally on patent hold. So it was approved.
And when did pharma science receive this document? January 5, okay. And can we mark that as an exhibit? Just as then?
Yes, exhibit 19.
And What date did Health Canada approve pharma sciences drug submission? January 2. Did pharmacists receive its NOC on that date?
No, because of the ongoing NOC proceeding.
Okay. I'd like to switch to discussion of the application in the federal court against farmer science. Did that application proceed through a hearing? Is it okay I'm going to turn farmers science seven production seven which is FC 66. And if we can just go to page two. Do you recognize this document?
Yes, this is the court decision on nor NOC persoon.
Can we mark that as the next exhibit justice?
What's the EFC number for this?
FC 66
That's exhibit 20.
And when did farmer science receive this document
on December 6 2016, okay,
and I'm going to put up now farmer science production aid, which is FC 67. And if we can just turn to page three, you recognize this document?
Yes, this is Health Canada's issuance of the NOC for Rs. OpenAM.
Okay, thank you. Now we'll switch to a different topic and you've testified
exhibit counsel. Oh,
pardon me. Yes. Thank you.
Exhibit 21.
Now, Mr. Pugh testified previously in the federal court in relation to Section Eight claims under the NOC regulations. Yes. Okay. And you're familiar with the concept of the buffer world or hypothetical world? Yes, I am. And I've got questions for you relating to what pharma science would have done if it had not been required to litigate when it filed its zolpidem drug submission in 2014. First of all, if pharma science did not have to address the regulations would that have had any impact on the date zolpidem development was initiated in 2011? No, it would not. And would not have had any impact on the gates.
It wouldn't have impacted the first four development gates, but it would have impacted the commercial date we would gate excuse me, we would have validated much sooner.
And when would you have validated your batches in this hypothetical world?
I processes to validate the first validation batch 11 to 12 months before projected launch, but that can be compressed depending on the timeline of the bio study versus regulatory approval.
In the real world, we looked at the regulatory affairs documents that that Justice sent asked you about and they had an expected review completion by Health Canada of January or February of 2015. So if we back up a year earlier had pharma signs done any validation as of January or February 2014.
Didn't know the ports you're referring to were only available in the summer. In June, July. Back in January, we were still projecting a luncheon in March or April of the following year, so we hadn't commenced validation at that point.
And then as of March or April 2014, then had pharma science done any validation?
No, because at that point, we were aware of the patent that was listed on the registers. So our launch date was now delete a year.
Okay, so no patent had been listed at the time farmer signs filed his AMDs in May of 2014. When would farmer signs have done its first validation?
We would have seen Regulatory Affairs projection in that June or July report projecting or approval in January or February, so at that point in time, we would have commenced validation
and when are the second and third validation is typically done.
Typically, they're done five to six months before launch.
And so in this but for a world when widows have taken place, the second and third validations
they would have been done immediately after this successful first validation batch.
And in terms of ordering API, when would you have done that for validation
batches? I don't think that would be any different than the real world. I think we would have ordered API upon the successful bio study results in Feb. January, February.
Okay. And what was Glenn marks lead time to fight API in 2014. They had a three monthly time who would have been in charge of the decision to launch zolpidem if it was at risk of patent infringement. Our CEO David Goodman, okay. Now, you're familiar with the concept of generic internet changeability designations? Yes, I am. And can you just explain in general terms what those are.
Many of the provinces have a formulary that Diem interchangeability which will allow a pharmacist to dispense the generic if the brand is prescribed.
Does pharmacists apply for interchangeability with its products?
Yes, we do. And why is that? So that the pharmacist can dispense our generic if the brand is prescribed. For a particular
product? Did farmer signs apply for interchangeability designations in the real world for zolpidem? Yes, we did. And is that interchangeability designation something that farmer science would have applied for in the butthole world? Yes, we would have and when would that have been done relative to receiving an NOC
normally, right after a very shortly after receiving the NOC we would apply for interchangeability.
Okay, thank you so much. Those are all my questions.
Thank you. Thank you very much
just as in my friend actually went through a number of the same documents I was going to go to if it'd be possible to take the morning break, I can try and update to make sure I use the same exhibit numbers, but I'm in your hands. I'm happy to just start if you'd prefer,
we can take 15 minutes. We'll adjourn then for 15 minutes. Thank you
