[00:00:00] Speaker 04:
Good morning.

[00:00:01] Speaker 01:
Good morning, Your Honors. I'd like to reserve two minutes for rebuttal.

[00:00:05] Speaker 04:
All right.

[00:00:07] Speaker 01:
May it please the Court, my name is George Alakin. I'm here on behalf of Fumizer LLC, the petitioner on this matter.

[00:00:14] Speaker 01:
And as we've discussed these notice requirement rules, I'd like to move directly to the more pointed arguments on this matter specifically.

[00:00:25] Speaker 01:
The first being the timeliness issue of the filing.

[00:00:30] Speaker 01:
FDA received the marketing denial order through delivery on July 23rd. It filed this petition on August 22nd, which is 30 days and within the federal rules of appellate procedures.

[00:00:45] Speaker 04:
It's late.

[00:00:46] Speaker 04:
It's not within 30 days, right? Notice received July 22. Deadlines August 21.

[00:00:53] Speaker 04:
Petition for review filed August 22.

[00:01:00] Speaker 01:
It was received July 23, and you can find the UPS tracking on the respondents' motion to dismiss exhibits.

[00:01:09] Speaker 04:
I thought there was a phone call notice and email with a copy of the MDO attached on July 22.

[00:01:15] Speaker 01:
So I'd like to discuss those three items all together, Your Honor. So U.S. Code 387JE is very specific about the service requirements.

[00:01:26] Speaker 01:
There's only two ways to effectuate service on on these types of notices, one being in-person service and the second one being through registered mail or certified mail.

[00:01:39] Speaker 01:
The email or the first, starting with the first one is the telephone call.

[00:01:45] Speaker 01:
Telephone call doesn't purport to provide any information other than receiving an email courtesy copy. So there's no information to even be presented there. The second argument, the second notice, which is included in respondent's motion to dismiss, is the email that was purportedly sent out on July 22nd. On top, it clearly states that it's a courtesy copy. It's not an actual service. It's not where Fulmeiser is not agreeing to actually accept service.

[00:02:15] Speaker 04:
So let me make sure I understand your position. So there's no dispute that a phone call was made, right? giving notice that a denial was issued and the email was sent out with a copy of that.

[00:02:31] Speaker 04:
But you're saying that that's not sufficient to constitute notice. Is that your position?

[00:02:36] Speaker 01:
To clarify, Your Honor, as far as the prior notices that were received by telephone call through Frohmeiser, generally speaking, it's never to discuss what the basis of the notice is. It's just that there is a notice and if If you actually look at the email that was submitted as an exhibit by respondents, it states that it's a courtesy copy and the petitioner has agreed to receive a courtesy copy.

[00:03:05] Speaker 01:
While we don't have a record of that email, it's not in dispute that it was sent out to the petitioner on this, but the U.S. Code 387.2 is exceedingly clear that it service can only be effectuated. Point one is through personal service. Point two is by actual, actually, um, USPS registered mail or certified mail. So even moving on to the, to the, uh, the timeliness, which it was delivered July 23 petition was filed August 22nd.

[00:03:40] Speaker 01:
However, I don't think it would be unreasonable to even argue that that wasn't even sufficient notice because it was sent us, excuse me, UPS, um, next day mail, which actually clearly falls outside of the, the, um, the codes requirements, which is registered mail and, and, um, certified mail. It's, it's clear in that and UPS will under any condition will never actually qualify as either one of those two. So even as we stand here today, I would say it wouldn't be unreasonable to argue that Fulmiser still hasn't received effective notice of the, the, um, the actual marketing denial order.

[00:04:22] Speaker 00:
Where's that argument in your brief?

[00:04:24] Speaker 00:
Can you point that out, please?

[00:04:26] Speaker 01:
Sure, sure.

[00:04:28] Speaker 00:
As far as the... No effective service.

[00:04:32] Speaker 01:
It was actually in the first part of the argument.

[00:04:38] Speaker 01:
When my argument starts, I first address the... My first heading is regarding the effective service, and then I move on to the arguments...

[00:04:48] Speaker 01:
in relation to the MDO.

[00:04:51] Speaker 01:
And I believe it was addressed in my reply brief as it was brought up as an argument and respondent's answer.

[00:04:59] Speaker 00:
If you can just give me a page number, that'll help me out.

[00:05:01] Speaker 01:
If it's all right with you, I'll grab my... That's all right. Go ahead. And just on that alone, the code is as clear as it is. And even if we just acknowledge for whatever reason that the UPS service was considered to be effective service, then it was delivered as evidenced in respondents' exhibits July 23rd. Fumizer filed their petition August 22nd.

[00:05:32] Speaker 01:
So it would be within the 30 days.

[00:05:35] Speaker 00:
Well, the 30-day runs by the language of the statute from the date of denial, right? That's what the statute says.

[00:05:42] Speaker 01:
It does say date of denial, but it also – very clearly identify service and, and in the cases that were addressed by, uh, respondent, it's, it's, there's a big distinction between how the word issuance is, is, uh, uh, is used versus it's not, there's no such language in this. It's, it's, uh, uh, it just clearly goes straight to denial and then referring to 387.

[00:06:08] Speaker 01:
And at that point it's, it's services becomes the, the issue where, um, I don't believe there's a proper service on those prior telephone calls or the email.

[00:06:20] Speaker 00:
All right. I think you can move on to the other points, but thank you. Thank you.

[00:06:23] Speaker 04:
Assume for a moment that we don't agree with you on the lack of service or notice. Can you give us your best argument on whether equitable tolling should apply?

[00:06:33] Speaker 01:
Yes, Your Honor. So as far as on equitable tolling, even giving the – The arguments that we just brought up as far as notice not being properly available, I think as far as the actual standard of how this notice was delivered was confusing enough and unclear enough to petitioner that the one-day issue shouldn't be of whether it's delivery or notice or actually the alleged...

[00:07:11] Speaker 01:
violation occurred shouldn't be considered as far as, um, um, fatal to petitioner, especially when, um, looking at the context of, you know, the, the cases that were brought up by respondent, um, um, versus this case here, if this was an internal memo with a date that was set as July 22nd and hadn't been sent out for weeks or however period of time.

[00:07:36] Speaker 04:
Well, I mean, I think the problem I have with that, um, It's assuming that we find that notice was in fact provided, whether by phone call, email, with the order attached, or combination of both.

[00:07:53] Speaker 04:
Equitable tolling applies only if you're pursuing your rights diligently and something extraordinary stand in the way. I'm not unsympathetic to the fact that it's one day late. It's not super late, but at the same time, it doesn't automatically mean that equitable tolling applies.

[00:08:12] Speaker 01:
Well, Your Honor, as far as the circumstances in which the submission was actually – the marketing denial was actually delivered, it did create a certain level of confusion. I think there was an email that was sent out on August 22nd, which was also included in the respondents' exhibits with Fumizer actually asking – what the status of that phone call was or whether there was a document that was going to be submitted in response to that.

[00:08:48] Speaker 01:
And at that point, it was discovered that there was an actual MDO issued. So on that end, I think it actually caused more confusion than actually clarity as far as when it was issued.

[00:09:11] Speaker 01:
Um, the, the next point I'd like to, to address is as far as, um, uh, the, the denial on its merits. So in, in this particular case, it's a, it's a much narrower, um, um, application of the, the administrative law. As far as Fulmeiser is not asking the court to second guess its scientific standard, it's not asking them to, to, um, uh, review based on, based on, um, any ambiguity.

[00:09:42] Speaker 01:
In this case, FDA had denied Fulmiser's application based on the fact that it was lacking a longitudinal switching study or any data to that effect. However, far before the denial, Fulmiser on May 28th submitted an amendment that included the switching study protocols that included statement of work with a company that it contracted to proceed with that had timetables, data points, and a meaningful end date.

[00:10:16] Speaker 01:
In addition, it provided a longitudinal cohort study to show what the basis of its actual study was going to rely on.

[00:10:29] Speaker 01:
And in the July 23rd denial. The only thing as far as there was a reference to an appendix B on their marketing denial order that referred to the actual longitudinal study, but didn't actually engage with it meaningfully. And I think the biggest issue there is it shows that it's been received. It shows that FDA has been in possession of it, but when you actually go through their technical product lead review, it doesn't engage with that amendment in any meaningful way.

[00:11:09] Speaker 01:
It acknowledges its existence. It acknowledges that there's still no final data as to the study, but doesn't actually review through the way it does with all the other studies and all the other documentation that was in the actual original application and the prior amendments.

[00:11:31] Speaker 01:
given that this is data under 1114.9, as a major amendment, it should restart the clock, not to say that it's an actual ceiling to the 180 days, but it should restart the review period. Following the restart of that review period, it's when an analysis is being done, the FDA should review and meaningfully engage with the data, but it appears that it's as far as that process was just conclusory, there's as in it just overlooks it as something there, but doesn't actually touch it in any meaningful way.

[00:12:15] Speaker 01:
As far as the FDA's review process, it actually goes hand in hand with, as we've been hearing today, and many of its other matters, it's the majority or all of these arguments have been towards flavored tobacco products.

[00:12:35] Speaker 01:
And not to make this a significant issue in this case, but while it's referring to Fumizer's flavored products, it also included a tobacco product in there. And it's tobacco platinum number one. And peculiarly enough, it's out of four of those different nicotine levels that picked one of them to include in the denial for, for this application. And I think it's the, to not argue schematics, but as far as it, it's, um, it shows that the FDA is not meaningfully reviewing the actual application process when it's holding, um, a tobacco flavor product in the same category and not actually, um, distinguishing it in any way.

[00:13:23] Speaker 01:
Um, as far as the, as far as its, um, with the position on this case, it's, it's a distinguished from wages and line and, and the Lotus matter, because as far as the, we're not arguing the notice requirement, we're not arguing whether or not the FDA is, is allowed to create a actual robust process. It's just more so that while Fulmiser has been operating under that process, it still hasn't got the opportunity to have a meaningful review of its application and, and to, To further highlight that, it's not whether or not the FDA made the right decision in its conclusion.

[00:14:06] Speaker 01:
It's that it didn't go through the process. If it had actually reviewed the materials, identified it, and not to say that it needs to do a page-by-page analysis, but referenced its review of it and then made a determination, this This matter wouldn't be heard here today. It's the fact that it bypassed- Sorry to interrupt.

[00:14:26] Speaker 04:
I know you wanted to save a little bit of time and you're down to less than 50 seconds, so.

[00:14:30] Speaker 01:
Sure.

[00:14:32] Speaker 01:
Thank you.

[00:14:45] Speaker 03:
Good morning, Your Honors, and may it please the Court. Jack Starcher on behalf of the United States.

[00:14:50] Speaker 03:
This court should dismiss this petition as untimely, and I think the most straightforward path for this court to do so would be as follows. To first observe that at ER 3, in the excerpts of record in this case, the marketing denial order issued to petitioner here is dated July 22nd. That's on the face of the document that is challenged in this petition.

[00:15:11] Speaker 04:
This is the exact copy that was attached to the e-mail?

[00:15:15] Speaker 03:
Yes, that's my understanding, that it's identical to the version that was mailed, and then which is identical to what appears in the record, that there's only one version.

[00:15:25] Speaker 03:
I think that fact, coupled with the fact that this court has repeatedly held, and this is the case discussed, the cases, I should say, discussed at page 30 of our brief, that these sorts of deadlines flow from the date of the agency decision, and that actual notice or receipt of that decision isn't important.

[00:15:45] Speaker 03:
And then third, even assuming this is not a jurisdictional limitation, equitable tolling is not available on these facts.

[00:15:54] Speaker 03:
And then four, therefore dismissed as untimely. I think that's the most straightforward path here. I'm happy to talk about the merits or to talk about why we do think this is a jurisdictional limitation. But for the reasons just given, I don't think the jurisdictional versus non-jurisdictional distinction needs to be resolved in this case if the court's not inclined to address it.

[00:16:15] Speaker 00:
So was service made in compliance with what the statute provided for effective service?

[00:16:21] Speaker 03:
I don't have that.

[00:16:22] Speaker 03:
Those arguments didn't appear. That statutory section didn't appear anywhere in the briefing, or at least I don't believe so. I believe that's about service of process, although, again, I don't have the statutory section in front of me. But, again, I don't think any of that is relevant because of this court's decisions saying that these sorts of timelines – for review of agency decisions flow from the date of the agency decision itself.

[00:16:50] Speaker 02:
Yeah, assuming that's true, but presumably you'd still have to give them notice somehow, right? I mean, there would be some argument that if they never received it, didn't know about it, but that's just not the issue here.

[00:17:03] Speaker 03:
Exactly.

[00:17:03] Speaker 02:
And I don't know what the rule would be if this is an interesting argument that's been raised about wrong method of service, so maybe never service it, but that argument, I think you just said that that argument was not in the brief, and I didn't see it in the briefing at all.

[00:17:35] Speaker 03:
given Infumizer's own application for communication about the application?

[00:17:39] Speaker 04:
I don't think he's disputing that. I clarified that, and counsel's not disputing it. But he says there's some confusion in the record. And so that argument, I think, flows into whether equitable tolling should apply in the case.

[00:17:52] Speaker 03:
Sure. And I think if you look at the circumstance, I guess my first response to that is I think any confusion here is substantially undercut by the fact that the document itself has a date on it, and that date is July 22nd. And again, that's ER3 on which that appears.

[00:18:07] Speaker 03:
And then on equitable tolling, I think if you look at the Supreme Court's decision in Irwin and this Court's decisions, considering when equitable tolling is appropriate, it really has to be something extraordinary. It has to be some action taken to frustrate the ability of the individual seeking review to seek review. And as you noted, another factor that courts look to is that the individual seeking equitable tolling must make a showing that they exercised reasonable diligence in getting review of the decision.

[00:18:38] Speaker 03:
I take it that even under, you know, this petition was in fact filed 31 days later. And so I think even under petitioner's view, it was reasonable to get it 31 days after the issuance of the decision. There's no explanation for what was happening in that one day period that frustrated their ability. And again, I think the only thing that I heard was confusion. And again, I think that's undercut by the record here.

[00:19:05] Speaker 03:
I'm happy to talk about, again, anything else than the challenges to the merits of the denial order or this jurisdictional question. But if there are no further questions, we ask that you dismiss us on time.

[00:19:16] Speaker 04:
All right. Let me see if my colleagues have any questions. All right. Thank you very much.

[00:19:47] Speaker 01:
Your Honor, just a reference as far as the arguments made in our reply brief. They were first addressed in the motion of dismiss provided by a respondent. Our opposition was primarily, obviously, about the timeliness issue.

[00:20:04] Speaker 01:
It wasn't addressed in our brief as it had been the driving force in this, but then as far as when it was addressed in the answer, on page three of the The reply brief is where our argument starts regarding the timeliness issue.

[00:20:25] Speaker 01:
As far as the service issue and the notice issue, again, I'd ask this court to consider the two parts of this as far as if we were to go off of the – I mean, your argument at this point was that – it's an interesting argument that it was – essentially your argument is that it was never served because it was statued.

[00:20:46] Speaker 02:
But on page five, you say the petition was filed within 30 days of the service date, which seems to – I just don't see that argument you were making in these first few pages of your reply brief. So as far as the – That it wasn't ever properly served on you because it was sent UPS instead of USPS.

[00:21:06] Speaker 01:
So as we were in actually disputing service based on the – UPS delivery versus it being USPS. We weren't trying to fight over that technical issue.

[00:21:17] Speaker 01:
However, assuming that's not even an issue is assuming that UPS is considered sufficient service.

[00:21:26] Speaker 01:
I don't see how a telephone call where it doesn't describe the nature and the details of what a notice is sufficient as proper notice on a on a denial order as something as significant as a PMTA application. And then following that, an email that says this is based on courtesy and an email that's unprompted and forwarded to a petitioner is also somehow considered to be noticed under this.

[00:22:00] Speaker 01:
If that was the case, then it would not be labeled as courtesy. It would be more of a dialogue about whether or not this is Does the petitioner accept electronics?

[00:22:09] Speaker 04:
Got your argument, counsel. You're well over time, but I appreciate your argument this morning. This matter is also submitted. Thank you. Thank you.