[00:00:00] Speaker 01:
Case number 25-5041.

[00:00:01] Speaker 01:
Banda Pharmaceuticals in advance versus United States Food and Drug Administration head out.

[00:00:09] Speaker 01:
Mr. Fees for the conditioner, Mr. Peters for the respondent, Mr. Burgess for the intervener at below.

[00:00:16] Speaker 01:
Good morning, Mr. Hughes.

[00:00:17] Speaker 01:
Thanks to all counsel for their patience.

[00:00:22] Speaker 06:
Good morning, Your Honor.

[00:00:23] Speaker 06:
May it please the court, Paul Hughes, for Banda Pharmaceuticals.

[00:00:28] Speaker 06:
With years of work and millions of dollars of research, Vanda brought Hetlios to the market.

[00:00:34] Speaker 06:
Hetlios treats non-24, a disorder that primarily affects blind individuals.

[00:00:41] Speaker 02:
And what's the second thing it treats?

[00:00:44] Speaker 06:
SMS, Smith-McGinnis syndrome.

[00:00:46] Speaker 06:
It's a genetic disorder that affects principally children.

[00:00:51] Speaker 06:
So there's both a capsule form and a vikinder.

[00:00:57] Speaker 06:
Vanda sought and obtained the first ever FDA approval to have a drug label with Braille on the label.

[00:01:05] Speaker 06:
Now, generic drug makers have entered the marketplace.

[00:01:09] Speaker 06:
One of the generics, MSN, did put Braille on their label.

[00:01:12] Speaker 01:
How many generics are in the marketplace?

[00:01:14] Speaker 06:
There are three generics currently in the market.

[00:01:17] Speaker 01:
What happens to the, what happened to, so sorry, one app, so it's Apotex, MSN, and Teva, Teva or Teva?

[00:01:24] Speaker 06:
Teva, Your Honor.

[00:01:26] Speaker 01:
MSN, Apotex, and Teppa.

[00:01:29] Speaker 01:
Apotex doesn't use Braille.

[00:01:31] Speaker 06:
They do not, Your Honor.

[00:01:33] Speaker 01:
You haven't sued them.

[00:01:34] Speaker 06:
Well, Your Honor, when we filed this lawsuit, they had not yet entered the market at the time.

[00:01:39] Speaker 06:
So what the timeline in the case was this lawsuit was filed initially after Teva had entered the market.

[00:01:46] Speaker 06:
And that's when we first found out that they were not putting Braille on their label.

[00:01:51] Speaker 06:
Apotex not enter the market for a significant period of time after after which period of time a citizen petition there.

[00:01:58] Speaker 06:
Yes, Your Honor, I believe we do have a system.

[00:02:00] Speaker 01:
Can you challenge the end on their case too?

[00:02:02] Speaker 06:
We have not yet challenged the end of their case on the basis of the Braille issue.

[00:02:08] Speaker 01:
Sorry, I'm just trying to figure out, is the time run or not yet run?

[00:02:11] Speaker 06:
No, Your Honor, we have six years from the ANDA approval, and there's even more time from this as a petition denial.

[00:02:18] Speaker 06:
Again, recognizing it's a common legal issue, I do think this would govern both Apotex and Tadlet, but we've not yet sued over the Apotex ANDA.

[00:02:26] Speaker 01:
Well, we don't know.

[00:02:26] Speaker 01:
I mean, you have a challenge to the agency's decision-making on the ANDA, and we don't know what their explanation would be in the Apotex case.

[00:02:33] Speaker 01:
I'm just trying to figure out, remedially, you argue about injury

[00:02:39] Speaker 01:
competition but if there's another generic out there doing the exact same thing, presumably these other generics are just going to fill up the demand.

[00:02:49] Speaker 01:
Is there really a concrete injury change if you take one player out but there's two more generics already out there and as of now you've done nothing to challenge one of those generics which also is not using Braille.

[00:03:02] Speaker 06:
So several responses that your honor, to the extent the court's asking about standing issues, obviously standing.

[00:03:10] Speaker 06:
There's been no challenge to standing.

[00:03:13] Speaker 06:
I think that's for good reason.

[00:03:14] Speaker 06:
There are many aspects to standing.

[00:03:16] Speaker 06:
There's of course competitor standing.

[00:03:18] Speaker 06:
So having one competitor not in the marketplace, that would have direct implications even if other competitors exist in the marketplace because in pharmaceutical pricing, it's a complex issue about drug pricing, but the more competitors are that has effects on price.

[00:03:34] Speaker 06:
setting that aside.

[00:03:35] Speaker 06:
The real reason Vanda is here is Vanda created the marketplace for Tazumaltin for Helios.

[00:03:42] Speaker 06:
It's a market that is principally used by blind individuals.

[00:03:45] Speaker 06:
And when Vanda did so, it was really important to the company to have Braille on the label for the product.

[00:03:51] Speaker 06:
FDA has made the determination that generics don't have to have Braille on the label.

[00:03:55] Speaker 06:
And we're here challenging that.

[00:03:57] Speaker 06:
If we succeed in this challenge, we would certainly continue to bring press that claim to Apotex if

[00:04:03] Speaker 06:
FDA itself doesn't require that labeling change to Apotex if we prevail on the principal legal question.

[00:04:09] Speaker 06:
But again, the nature of this case being against Teva is, I think, an artifact of the case that just Apotex didn't go on the market for a substantial period of time after Teva entered the market.

[00:04:21] Speaker 06:
We didn't know what their label was going to be.

[00:04:22] Speaker 06:
And this case was already well-launched at that time.

[00:04:26] Speaker 01:
Could you have filed a more timely citizen petition that said,

[00:04:32] Speaker 01:
whatever you do, make sure they have to use Braille.

[00:04:36] Speaker 06:
I mean, Your Honor, we filed a system petition within a few weeks of their launch of the product, which is when we first learned that they weren't using Braille.

[00:04:43] Speaker 01:
No, you knew they were going through, did you know they were going through the ANDA process?

[00:04:47] Speaker 06:
We knew there were generics going through with ANDAs, yes, Your Honor.

[00:04:50] Speaker 01:
Okay.

[00:04:50] Speaker 01:
Including, did you know the names of the generic company?

[00:04:52] Speaker 01:
I mean, did you know it was Teva and Apotex?

[00:04:55] Speaker 06:
Yes, there was patent litigation.

[00:04:56] Speaker 06:
Yes, Your Honor.

[00:04:56] Speaker 01:
Okay.

[00:04:57] Speaker 01:
And so you knew that was all going on and you didn't tell FDA.

[00:05:01] Speaker 01:
Back then, well, you know, in our view.

[00:05:06] Speaker 01:
labels have to have Braille on them.

[00:05:09] Speaker 06:
MSN's label did have Braille on it.

[00:05:11] Speaker 01:
I know, but you didn't.

[00:05:14] Speaker 01:
Was that just happy coincidence for you?

[00:05:16] Speaker 06:
Well, no, we think MSN followed the statute.

[00:05:18] Speaker 06:
The statute says we have the same label.

[00:05:19] Speaker 06:
I'm sure we'll be talking about that.

[00:05:21] Speaker 06:
But I don't think Vanda had to predict that in our view, FDA was going to violate the statutory same label requirement and that we had to go remind FDA, here's what the statute says, please apply it in these circumstances.

[00:05:32] Speaker 01:
unprecedented application of the statute.

[00:05:34] Speaker 01:
I mean, that's not the merits one way or the other, but I'm not sure one could have assumed that so comfortably.

[00:05:42] Speaker 06:
Well, and let me be clear, Your Honor, we're not here on an injunctive relief request.

[00:05:45] Speaker 06:
We did file a preliminary injunction in this case that was denied.

[00:05:48] Speaker 06:
We did not appeal that.

[00:05:50] Speaker 06:
So if the court is asking what are the equitable factors, to be sure, I don't think any court has said one has to file a citizens petition in advance of a launch, hypothesizing ways in which a generic

[00:06:02] Speaker 06:
would violate the Food Drug Cosmetic Act and ask FDA to stop it.

[00:06:06] Speaker 06:
I don't think there's any part of diligence that would require that.

[00:06:09] Speaker 06:
Here, this was filed in January of 2023, which I believe was about three weeks or so after the launch.

[00:06:17] Speaker 06:
It may have been.

[00:06:19] Speaker 06:
I'll go back and check that, your honor.

[00:06:21] Speaker 06:
But it was launched very quickly.

[00:06:23] Speaker 06:
So there was absolute diligence.

[00:06:24] Speaker 06:
But I think that inquiry also would only be relevant if we were talking, for example, on the preliminary injunction posture where those equitable factors would really weigh.

[00:06:32] Speaker 06:
We're past that at this point.

[00:06:33] Speaker 06:
We're not asking for a preliminary injunction in this case.

[00:06:36] Speaker 06:
We're asking for a ruling on the straightforward legal question, where the parties have cross-moved for summary judgment as to was the ANDA and also, by consequence, the citizen's petition denial correct as a matter of law in saying that the removing of braille was appropriate exercise of the different manufacturer exception to the same labeling requirement.

[00:06:57] Speaker 01:
No, the probably, I mean, the difficult, this is not a standing question at all, but.

[00:07:04] Speaker 01:
I mean, am I correct that the citizen petition was filed and then lawsuits are 6 days later?

[00:07:09] Speaker 01:
Is that right?

[00:07:11] Speaker 06:
Yes.

[00:07:11] Speaker 01:
So the agency never had a reasonable chance to act on the citizen petition before the lawsuit.

[00:07:16] Speaker 06:
Well, what happened here?

[00:07:20] Speaker 06:
We filed the lawsuit because we went to the agency.

[00:07:22] Speaker 06:
We asked the agency for immediate relief saying, this is really urgent.

[00:07:25] Speaker 06:
We want you to have Braille on the product.

[00:07:27] Speaker 06:
The agency did not act.

[00:07:29] Speaker 06:
Yes, it was within a matter of days.

[00:07:30] Speaker 06:
We then filed a preliminary injunction asking the court for immediate action.

[00:07:34] Speaker 06:
We were not successful with that.

[00:07:35] Speaker 06:
We had parallel actions before FDA and the court.

[00:07:38] Speaker 06:
And then the court wound up staying the litigation in the district court pending the resolution of the citizens petition.

[00:07:45] Speaker 06:
I agree.

[00:07:46] Speaker 06:
The exigency that we raised and we pressed, we did not prevail on, but that's also just not before the court at this point.

[00:07:53] Speaker 06:
And the court did wait for the Citizens Petition to be resolved and then allowed that to come into the case.

[00:07:58] Speaker 06:
And we had cross motions that went to both the ANDA approval as well as the Citizens Petition decision.

[00:08:03] Speaker 01:
And so what is the, what is, how do we think about, because you have a briefer decision at the ANDA stage about the Braille labeling.

[00:08:16] Speaker 01:
A more thorough one.

[00:08:17] Speaker 01:
We have more time, I guess.

[00:08:20] Speaker 01:
I don't know if we're more aware of the challenge at the citizen petition stage.

[00:08:28] Speaker 01:
Do we consider one of your arguments, to the extent you're arguing that they gave insufficient reasoning at the ANDA stage, but if they gave the more thorough reasoning you want in their answer to the citizen petition,

[00:08:48] Speaker 01:
What would be the point of, does that moot, does that overtake your?

[00:08:53] Speaker 06:
Your honor, I think our arguments.

[00:08:55] Speaker 01:
Those particular arguments.

[00:08:56] Speaker 06:
Yeah, when we talk about.

[00:08:57] Speaker 01:
It's not your contrary to law, your arbitrary and capricious arguments to the end.

[00:09:01] Speaker 06:
Your honor, I think we're willing to agree that for our arbitrary and capricious arguments, we will take into account all of FDA's reasoning.

[00:09:07] Speaker 06:
I think arbitrary and capricious arguments still withstand all of FDA's reasoning in the citizens petition.

[00:09:13] Speaker 06:
But I do want to focus.

[00:09:15] Speaker ?:
Sorry.

[00:09:15] Speaker 01:
You didn't make in your briefing, as I understand it, arbitrary and capricious challenges to the citizen petition decision.

[00:09:21] Speaker 01:
It was just contrary to law.

[00:09:23] Speaker 06:
your honor, I understand our briefing for the arbitrary and capricious was looking at the FDA determination as a whole, both the decision and the citizens petition.

[00:09:33] Speaker 06:
Now, what is, I suppose what is a technical matter, what we're asking the court to set aside is the decision.

[00:09:39] Speaker 06:
And so that is for APA matters, what it is we are technically asking the court to set aside.

[00:09:44] Speaker 06:
But I don't think we would object to the notion that

[00:09:48] Speaker 06:
material that the FDA decided in the citizens petition would be relevant to the court's consideration.

[00:09:53] Speaker 06:
We're not asking the court to close its eyes to the citizens petition decision.

[00:09:57] Speaker 06:
But as I said, the focal point of the brief is the contrary to law argument, which I think is

[00:10:04] Speaker 06:
common to both the end approval as well as a citizen petition.

[00:10:07] Speaker 06:
It is a straightforward question of love.

[00:10:10] Speaker 06:
Does the manufacturer exception to the sameness requirement do the work here?

[00:10:15] Speaker 06:
And we think the answer to that question is straightforward.

[00:10:18] Speaker 06:
Just no, it doesn't.

[00:10:19] Speaker 06:
Um to start

[00:10:21] Speaker 06:
looking at the textual analysis, I think we have to begin with the principle rule rather than starting with the exception.

[00:10:27] Speaker 06:
The principle rule here is the requirement that the generics label be the same as the branded products label.

[00:10:36] Speaker 06:
This is one of the many sameness requirements.

[00:10:38] Speaker 06:
It has to be the same

[00:10:40] Speaker 06:
ingredient and has to be the same dose.

[00:10:43] Speaker 06:
Other kinds of sameness that Congress required in order to provide generics the abbreviated process through which they can bring their products to market.

[00:10:51] Speaker 06:
So that is the principle.

[00:10:53] Speaker 01:
Other sameness requirements?

[00:10:55] Speaker 01:
The other ones.

[00:10:56] Speaker 01:
The whole lot of sameness required in the end of process.

[00:11:01] Speaker 01:
Identity?

[00:11:02] Speaker 01:
Or do they require sort of

[00:11:06] Speaker 01:
substantive or sameness as the substantive, the material.

[00:11:12] Speaker 06:
Well, so I think it depends on the sameness requirement your honor is considering.

[00:11:16] Speaker 06:
For example, the ingredient requirement, it is the identical substance.

[00:11:24] Speaker 06:
Similarly for dosage, it has to be the same dose.

[00:11:26] Speaker 06:
If it's 20 milligram as the branded product, the generic product has to be 20 milligram.

[00:11:31] Speaker 06:
Route of administration, again, that needs to be the same unless there is a petition that's providing a distinction for route of administration.

[00:11:39] Speaker 06:
a direct sameness requirement.

[00:11:41] Speaker 06:
I think that the district court pointed out in the bioequivalence test standard, there is a sameness of bioequivalence, but just given the nature of clinical testing, there might be some minor variation in test results for bioequivalence the statute takes account of, but it's still, I think.

[00:11:58] Speaker 01:
Well, compositional variations.

[00:12:00] Speaker 06:
There's going to be some, and there will be compositional variations because

[00:12:05] Speaker 06:
There are places in which the generic is able to make decisions about its product that changes from the brand product.

[00:12:12] Speaker 06:
So it is not an absolute identical carbon copy.

[00:12:15] Speaker 06:
And that can include things like inactive ingredients.

[00:12:18] Speaker 06:
So a generic can choose to use different inactive ingredients from the branded product.

[00:12:24] Speaker 06:
They can have different shapes of a capsule or a pill.

[00:12:29] Speaker 06:
And those are things that a generic has the ability to have some distinction.

[00:12:33] Speaker 01:
It's like material identity, material from the viewpoint of the and a process where we're talking about here, safe and effective drugs.

[00:12:40] Speaker 06:
Yes sir, I caution, I wouldn't necessarily say these things are immaterial, they can certainly matter, but what Congress said is there are certain things that need to be the same and there are other things that generics are going to have the ability to choose.

[00:12:52] Speaker 06:
Now, even for those things they have the ability to choose, it's not freewheeling, the FDA still approves those things, but it's not to say that the inactive ingredients have to be precisely identical and

[00:13:05] Speaker 06:
Nor does the process of manufacture have to be precisely identical.

[00:13:08] Speaker 06:
Another area where there does not have to be identicality of products that factors into some of the cases that get discussed is the Roman at eight, which allows an end application or an end applicant, the generic to apply for only a subset of indications.

[00:13:24] Speaker 06:
And the generic may do that called a skinny label in order to avoid exclusivities for data exclusivity that the FDA would hold or

[00:13:32] Speaker 06:
patent rights.

[00:13:33] Speaker 06:
So those are the certain kinds of permissible changes that generics can absolutely make.

[00:13:39] Speaker 01:
And so that situates what the- Able provision now, which is what this case is about.

[00:13:44] Speaker 01:
Obviously, absolute identity is not required or even permissible.

[00:13:52] Speaker 01:
There have to be changes, but they have to, for obvious reasons, FDA polices them very carefully with a lot of detail to make sure that it's

[00:14:03] Speaker 01:
They aren't variations that bear on safety and efficacy of the drug.

[00:14:10] Speaker 06:
Well, I think it goes more than that, Your Honor.

[00:14:12] Speaker 06:
The principle rule, the sameness, says it has to be the same label.

[00:14:18] Speaker 06:
And what the Supreme Court and Wyeth and then- Same doesn't.

[00:14:21] Speaker 01:
I get the statute says same, but we've agreed.

[00:14:25] Speaker 01:
I thought we just agreed that same doesn't mean identical.

[00:14:28] Speaker 01:
I didn't think you disputed that there were going to be ways in which this thing is not identical.

[00:14:33] Speaker 06:
Well, so I think let me parse two distinct things.

[00:14:37] Speaker 06:
I think there is what we call, and this kind of took a life on its own with the district where we disagree with some of the things the court said.

[00:14:43] Speaker 06:
We do think for the principal rule of sameness, there is a de minimis principle that would apply that you would say two things are legally the same, even if they are not precisely identical.

[00:14:53] Speaker 06:
So you look at a label and you can see de minimis changes.

[00:14:56] Speaker 06:
You wouldn't necessarily

[00:14:57] Speaker 01:
permissible to minimus.

[00:14:59] Speaker 01:
That seems to me, something might be in the eye of the beholder.

[00:15:03] Speaker 01:
But I mean, it seems to me that there are certain things, a lot of things that have to be identical, certainly in content.

[00:15:15] Speaker 01:
You know, you said the dosage thing, that there's 20 milligrams

[00:15:21] Speaker 01:
I mean, that just has to be the same as part of the drug itself being legitimately used.

[00:15:26] Speaker 01:
But also for obvious reason, you have to accurately identify that dosage on the label.

[00:15:31] Speaker 01:
So that's gonna be the same.

[00:15:33] Speaker 01:
Same font?

[00:15:35] Speaker 06:
Same font.

[00:15:37] Speaker 06:
Well, there'd be some trade dress issues, but I think font.

[00:15:40] Speaker 01:
From trade dress, assuming, because there are actually a lot of regulations even about what size and what has to be involved.

[00:15:46] Speaker 01:
But assume that's all complied with, can they pick a different font?

[00:15:49] Speaker 06:
If it is, again, this goes to where we think you would have a de minimis change.

[00:15:53] Speaker 06:
If it's not actually changing the readability, it is effectively the same thing.

[00:15:58] Speaker 06:
It's not conveying different information.

[00:15:59] Speaker 06:
It's not harder for somebody who might have vision difficulties to read.

[00:16:04] Speaker 06:
I think we would say that's a de minimis change, so it qualifies as the same.

[00:16:07] Speaker 06:
And you don't get into the exception for the different manufacturer.

[00:16:12] Speaker 06:
We would just say that's the same for effective purposes, the same label.

[00:16:15] Speaker 06:
And let me be clear, that's not the argument that that FDA or Teva has adopted here.

[00:16:21] Speaker 06:
They could have suggested an argument that this label is the same.

[00:16:25] Speaker 06:
So you don't even have to look to the exception.

[00:16:27] Speaker 06:
But they've never advanced that.

[00:16:28] Speaker 06:
And that's not what the FDA held.

[00:16:30] Speaker 06:
So from January principles, I don't think that would be an argument that would be available.

[00:16:35] Speaker 06:
And I'm happy to give the court citations.

[00:16:37] Speaker 06:
I'm sure the court's aware.

[00:16:38] Speaker 01:
But I mean, it's

[00:16:42] Speaker 01:
If it's not something isn't required.

[00:16:46] Speaker 01:
By saying this, then it would be.

[00:16:48] Speaker 01:
Then a different manufacturers discretion.

[00:16:53] Speaker 01:
Font size and again, that would be.

[00:16:57] Speaker 01:
I mean, you want to put it under de minimis, which the statute doesn't recognize.

[00:17:01] Speaker 01:
But I don't know why that wouldn't also be as changes made because they're a different manufacturer.

[00:17:07] Speaker 06:
Because there's nothing required about it.

[00:17:09] Speaker 06:
It misses the required element of that exception.

[00:17:12] Speaker 06:
So that's the key thing I want to talk to you.

[00:17:14] Speaker 06:
But to answer the court's question, we think those examples are not being dealt with in the changed required exception.

[00:17:21] Speaker 06:
they're being dealt with by the principle rule of what does it mean to be the same.

[00:17:25] Speaker 06:
And you can have two labels that have different fonts.

[00:17:28] Speaker 06:
But as a legal matter, because the law doesn't deal with trifles, we would say these labels are the same for legal purposes.

[00:17:35] Speaker 06:
Now, if FDA had wanted to make the argument that that principle sweeps in Braille and Braille isn't this is lacking Braille is the same.

[00:17:43] Speaker 06:
They could have suggested that they did.

[00:17:45] Speaker 06:
And I think there's a good reason they didn't.

[00:17:47] Speaker 06:
And that's because Braille really matters.

[00:17:48] Speaker 06:
It matters a lot to the blind community.

[00:17:50] Speaker 06:
So it's not a trifling issue.

[00:17:52] Speaker 01:
I mean, that's your argument.

[00:17:54] Speaker 01:
I think the FDA had pretty strong arguments that it doesn't make a difference.

[00:18:01] Speaker 01:
But put that aside.

[00:18:03] Speaker 01:
What I'd like to talk about is what you could say, then, if someone instead of Braille made the information super large and super bold to help with those not completely blind, but those with impaired eyesight.

[00:18:16] Speaker 01:
But if I could talk about the change of heart, would that be legally the same?

[00:18:21] Speaker 06:
probably not legally the same, Your Honor, and it would run afoul of the sameness requirement as what the Supreme Court in Pleva and Wyeth said.

[00:18:28] Speaker 06:
And Pleva's, I think, pretty important, because Pleva, in that case, the Supreme Court found preemption of state law on the basis that the generic could not go and try to put additional nice-to-have safety warnings on a label, even if the generic wants to do so.

[00:18:46] Speaker 06:
And what the Supreme Court's termination was is,

[00:18:49] Speaker 06:
These things that even might increase safety or make the statement better on efficacy are outside the scope of what's allowed that it has to be the same label.

[00:19:00] Speaker 06:
The only exception to that is if you're in the change require.

[00:19:03] Speaker 06:
And so what does change required mean?

[00:19:05] Speaker 06:
Our principal submission is for the

[00:19:07] Speaker 06:
The main rule, the same rule to have any effect and for the word required to do work, there has to be something external to a generic manufacturer's desire to change the label that requires that change.

[00:19:21] Speaker 06:
And there are a whole host of things that could be.

[00:19:23] Speaker 01:
So I mean, the difficulty here is because it's a generic, there has to be a change even to what would be in Braille.

[00:19:38] Speaker 01:
Right?

[00:19:39] Speaker 01:
You have your brand name in Braille and then the 20 and the 20MG.

[00:19:46] Speaker 01:
That's it.

[00:19:49] Speaker 01:
Obviously, they're not going to have a brand name in Braille.

[00:19:53] Speaker 01:
So, is your position that they just have to put 20MG in Braille?

[00:19:59] Speaker 06:
Would they do what?

[00:20:03] Speaker 01:
The law requires them to have in Braille.

[00:20:06] Speaker 06:
So I think what FDA did with MSN is the answer, which is MSN has, instead of Hetlios, like over the box, usually you'd have in Roman script Hetlios, and the generic instead of having Hetlios has tazamaltine.

[00:20:19] Speaker 06:
That is a change that's required.

[00:20:21] Speaker 01:
But you have tazamaltine right there, almost in a roving or right under your name, but you did not put the active ingredient in Braille.

[00:20:27] Speaker 01:
That is not the same.

[00:20:29] Speaker 01:
Having an active ingredient in Braille is very different from not having it in Braille.

[00:20:34] Speaker 06:
First, I would say, though, I want to get to that in a minute, but the 20 mg is definitely could be a requirement that's the same in that MSN copied the 20 mg directly.

[00:20:45] Speaker 06:
But what MSN also did that the FDA approved and we think is the way you operate.

[00:20:50] Speaker 01:
I understand they approved them putting the active ingredient in Braille.

[00:20:55] Speaker 01:
But you're the one who's saying it's got to be the same.

[00:21:00] Speaker 01:
And yet your label does not have the active ingredient in Braille and there's dust.

[00:21:08] Speaker 01:
And your argument is it's safer because now

[00:21:14] Speaker 01:
someone using this medication who knows Braille will be able to find out what the active ingredient is in MSN's product, which could be very, very important for a lot of safety and health reasons, which they can't find on your label.

[00:21:32] Speaker 01:
Right.

[00:21:32] Speaker 01:
Well, they know it's they they know it's Helios and somebody's like, I don't know how many people think the name brand means much of any.

[00:21:40] Speaker 06:
Well, I think our customers who've been using Helios for a decade plus know actually what Helios means more than they know what Tasmanian means.

[00:21:47] Speaker 06:
That's that's more, if anything, indicative.

[00:21:49] Speaker 06:
But that's where you have the

[00:21:51] Speaker 06:
Yes, no point to having the no, but this is where Alex why you change the label from Hellios to Tasmanian on the label in script.

[00:22:00] Speaker 06:
You do the same thing with Braille.

[00:22:02] Speaker 06:
That would be a change required, but the very least there's a little worried that.

[00:22:09] Speaker 01:
Having the active ingredient be in Braille.

[00:22:14] Speaker 01:
On the generic when it is not in Braille, if we take is giving your safety arguments.

[00:22:21] Speaker 01:
for people to understand what they're taking.

[00:22:23] Speaker 01:
Yours is not in Braille, theirs is.

[00:22:27] Speaker 01:
That is actually changing.

[00:22:38] Speaker 01:
the labels assertions of safety or demonstrations of safety as to this drug, because now people can tell what the active ingredient is in Braille, which they couldn't on yours.

[00:22:49] Speaker 01:
That's hard to think that that's just a de minimis label difference.

[00:22:54] Speaker 06:
Well, it's not a de minimis label difference.

[00:22:56] Speaker 06:
I agree with you on that.

[00:22:57] Speaker 06:
It's a change that's required by the different manufacturers.

[00:22:59] Speaker 01:
There's nothing required that they take something

[00:23:02] Speaker 01:
that you don't have in Braille, and that they put it in Braille.

[00:23:07] Speaker 06:
First, this is setting aside the 20 milligrams.

[00:23:08] Speaker 01:
It's the same about that.

[00:23:09] Speaker 01:
It's actually could be materially different.

[00:23:12] Speaker 06:
I mean, I think, Your Honor, the best upshot of your argument would be that you would not do the hetliocetazumelting, which I disagree with.

[00:23:18] Speaker 06:
The 20 milligrams sorry, my apologies, but the 20 milligram that is totally adjacent to this and this point doesn't address the 20 milligram that would be.

[00:23:30] Speaker 01:
So I'm trying to understand your position because I think for me, at least I'm not an expert.

[00:23:35] Speaker 01:
You guys are all everyone.

[00:23:36] Speaker 01:
Here's more expert than I am at this, but.

[00:23:40] Speaker 01:
Your argument is same means same means same means same and what's required and it's certainly not required that they put their active ingredient that MSM put their active ingredient in Braille.

[00:23:55] Speaker 06:
So it is required.

[00:23:57] Speaker 06:
I think it is.

[00:23:58] Speaker 01:
It doesn't need it.

[00:23:59] Speaker 01:
They don't need to do it because label just want a certain amount of Braille on the label.

[00:24:04] Speaker 06:
No, what we want is Braille on the label that conveys the essentially the same information that's on our label.

[00:24:11] Speaker 01:
I'm sorry.

[00:24:11] Speaker 01:
The name of a drug and what it actually is active ingredient is are not the same thing.

[00:24:17] Speaker 01:
But that is how the change required operationalizes because you get to pick that instead of our brand name, you've got to go to the active ingredient.

[00:24:26] Speaker 01:
What if instead they had put in Braille keep away from children?

[00:24:32] Speaker 06:
Well, I think that would be a same label requirement.

[00:24:35] Speaker 06:
They would need to move to keep away in children to braille.

[00:24:38] Speaker 06:
Sorry.

[00:24:38] Speaker 06:
No, no, no.

[00:24:38] Speaker 06:
You're saying if that was generic.

[00:24:40] Speaker 01:
Oh, if the generic, then that would be 20 mg and keep away from children.

[00:24:44] Speaker 06:
Well, again, let me just start with the base point.

[00:24:48] Speaker 06:
The 20 mg is sort of independent of this.

[00:24:50] Speaker 06:
So even if you don't like my argument as the Hetliostatasmaltz, which I think you should, I want to describe why the 20 mg argument withstands that.

[00:24:58] Speaker 06:
So that is there.

[00:24:59] Speaker 06:
regardless.

[00:25:00] Speaker 06:
But the reason why the Hetlios to Tazmeltian makes a great deal of sense, and that's what MSN did, is because when you look at the box label, the Roman script, you have Hetlios in large letters because that tells the patient what it is that is in that package.

[00:25:16] Speaker 06:
And then they'll have the active ingredient Tazmeltian in a much smaller script.

[00:25:20] Speaker 06:
that's allowed because Hetlios is the brand name for that product.

[00:25:24] Speaker 06:
When that product is switched to generic, for it to be the same, what generics do is put tazamaltine into that large script.

[00:25:32] Speaker 06:
So that way the patient can understand what is in that package.

[00:25:36] Speaker 06:
And this, I want to point the court.

[00:25:42] Speaker 01:
Just to explain what I'm not understanding here, and for now, we're tabling 20MG.

[00:25:50] Speaker 01:
I get that could be identical between the two.

[00:25:52] Speaker 01:
Just table that for now.

[00:25:59] Speaker 01:
Your argument is all about sameness, and anything that's not required has to be the same.

[00:26:07] Speaker 01:
Now, it is required that they take the name Hetlias off their product for obvious reasons.

[00:26:13] Speaker 01:
And somewhere in there, they're going to change who their manufacturer.

[00:26:16] Speaker 01:
They'll say Tiva instead of Vanda.

[00:26:18] Speaker 01:
Yes.

[00:26:19] Speaker 01:
OK.

[00:26:19] Speaker 01:
Those are required.

[00:26:20] Speaker 01:
Yes.

[00:26:25] Speaker 01:
But your argument is that we've got to have the

[00:26:33] Speaker 01:
it has to be the same.

[00:26:35] Speaker 01:
And so you need to have something in Braille that is not in Braille on the name brand manufacturers length.

[00:26:46] Speaker 01:
And that doesn't seem very same to me.

[00:26:49] Speaker 01:
And what I'm trying to understand is that you just want Braille on there so that someone could identify this as my particular vision medicine as opposed to my

[00:27:02] Speaker 01:
blood pressure or diabetes medicine or something like that.

[00:27:06] Speaker 01:
Is that the point?

[00:27:08] Speaker 01:
Or it has to be?

[00:27:10] Speaker 01:
I don't know how we get from active ingredient and name brand bean.

[00:27:16] Speaker 06:
This will take just a moment if I can.

[00:27:17] Speaker 06:
And one just side point is at J335, we do have active complaints from customers when their products have been switched who've called up the company to say there's no Braille on the product.

[00:27:29] Speaker 01:
Did you say complaints?

[00:27:30] Speaker 06:
No, it's a complaint, a complaint.

[00:27:31] Speaker 01:
I thought you said complaints plural.

[00:27:33] Speaker 06:
My apologies.

[00:27:35] Speaker 06:
We have at least a complaint.

[00:27:36] Speaker 06:
I don't know if we have plural, but we have more you would tell us.

[00:27:38] Speaker 01:
I'm sure.

[00:27:39] Speaker 01:
So how many people use it?

[00:27:41] Speaker 01:
Is these drugs combined the name brand and generics?

[00:27:44] Speaker 06:
It is a very small patient population.

[00:27:46] Speaker 06:
So one is not an insignificant number against the patient population.

[00:27:49] Speaker 01:
I know the patient population.

[00:27:51] Speaker 01:
I can't.

[00:27:53] Speaker 06:
I don't know.

[00:27:53] Speaker 06:
I'd have to check with the client.

[00:27:55] Speaker 01:
Are we talking hundreds?

[00:27:56] Speaker 01:
Yes.

[00:27:57] Speaker 01:
Not thousands.

[00:27:58] Speaker 06:
I would have to confirm with the client, it's a small patient population.

[00:28:01] Speaker 06:
This is an orphan drug in a rare disease state.

[00:28:04] Speaker 06:
So this is a, we're certainly not talking tens of thousands.

[00:28:09] Speaker 04:
So if I may, like this is related to Judge Millett's point.

[00:28:14] Speaker 04:
This is the way I've been thinking about it and tell me if I'm wrong.

[00:28:18] Speaker 04:
It has to be the same except for changes required because the new drug and listed drug are produced or distributed by different manufacturers.

[00:28:28] Speaker 04:
What is in Braille on Vanda's label is the name of the drug, Hetlios, and the dosage, 20 milligrams.

[00:28:39] Speaker 04:
You have to change Hetlios because that is required.

[00:28:44] Speaker 04:
It's a different manufacturer.

[00:28:46] Speaker 04:
But the Brailleness of it, you don't have to change the Brailleness because it's required by a different manufacturer.

[00:28:53] Speaker 04:
And this is evidenced by the fact that MSN has a Braille label and it didn't have to change it because it was a different manufacturer.

[00:29:01] Speaker 04:
But the content of what's in Braille has to change because it's a different manufacturer.

[00:29:06] Speaker 04:
It can't say Hetlios.

[00:29:08] Speaker 04:
It has to say whatever Teva is calling the drug.

[00:29:10] Speaker 04:
And the Tasmeltian part of it also goes to showing it's a different manufacturer because

[00:29:21] Speaker 04:
The patient population knows Hetlios is whatever the active ingredient is that they need, Tasmaltion.

[00:29:27] Speaker 04:
They associate it with Hetlios.

[00:29:30] Speaker 04:
But the Tasmaltion part of the different manufacturer shows different name.

[00:29:37] Speaker 04:
Consumers never heard of this before.

[00:29:38] Speaker 04:
It's a new drug.

[00:29:39] Speaker 04:
Tasmaltion shows that

[00:29:43] Speaker 04:
tells the consumer it's a different manufacturer, but it's the same active ingredient that you were having before.

[00:29:48] Speaker 04:
And that's why Tazmeltion can be considered, although I don't know if it's strictly required, but required because it's a different manufacturer.

[00:29:55] Speaker 04:
The name would show it's a different manufacturer, but the Tazmeltion also shows it's a different manufacturer with the same active ingredient.

[00:30:03] Speaker 04:
So it seems to me like the brailness

[00:30:07] Speaker 04:
has to remain because that can't be changed because it's a different manufacturer.

[00:30:12] Speaker 04:
And the content of what's in Braille has to identify the drug, the name of it, and in this case, Tazmaltianta, it's not Hetlios, and the 20 milligrams.

[00:30:23] Speaker 06:
I agree completely, Your Honor.

[00:30:24] Speaker 06:
And the point is it is a combination of the sameness requirement being married with a change required in that specific instance.

[00:30:32] Speaker 06:
The sameness is you keep the braille.

[00:30:35] Speaker 06:
The change is, hetliosis changed to tazamaltine in the same way.

[00:30:39] Speaker 06:
you would have the sameness requirement where in Roman scripts, the major feature of the Vanda package says Hetlios in Roman script.

[00:30:49] Speaker 06:
That large script that tells somebody this is what is in the package, that has to remain.

[00:30:53] Speaker 06:
What gets changed is instead of it saying Hetlios in Roman script, it has changed tazamalti in Roman script because that is a change required.

[00:31:01] Speaker 06:
Just because it's a change required doesn't mean

[00:31:03] Speaker 04:
Does it just say Tasmeltian, or does it also have some name like Hetlios?

[00:31:07] Speaker 06:
The generic does not say Hetlios.

[00:31:10] Speaker 04:
That's a copywritten name, so they don't put... No, but do they have some different copywritten name?

[00:31:14] Speaker 06:
It does not.

[00:31:15] Speaker 04:
So all it says is Tasmeltian?

[00:31:16] Speaker 06:
Yes, Your Honor.

[00:31:17] Speaker 06:
All it says is Tasmeltian.

[00:31:18] Speaker 04:
So that's what shows that it's a different manufacturer, that it's Tasmeltian and not Hetlios.

[00:31:23] Speaker 01:
Correct, because that's demonstrating it's the generic... What's a different manufacturer is whether it says Vanda or Teva.

[00:31:32] Speaker 06:
It's true that they would see that as well, but for in Braille, they're not in Braille or generic, but it's also a different manufacturer.

[00:31:40] Speaker 01:
That's what's required by being a new manufacturer.

[00:31:42] Speaker 01:
Putting the active ingredient rail is neither same nor required.

[00:31:47] Speaker 06:
The example, the analogy to judge pan's hypothetical is if Vanda had put.

[00:31:53] Speaker 06:
Vanda in Braille on the label, that would be the change.

[00:31:56] Speaker 06:
But let me be clear about this.

[00:31:58] Speaker 06:
This is not just free reign that Vanda puts whatever it wants on its label.

[00:32:02] Speaker 06:
This is approved by FDA.

[00:32:04] Speaker 06:
Vanda had to petition FDA to say, this is a drug that we know is principally going to be used by the blind population.

[00:32:11] Speaker 06:
We want to do something that allows these people to identify their medications.

[00:32:16] Speaker 06:
So FDA approved this.

[00:32:18] Speaker 04:
This was not a... Just following along though on Judge Millett's chain of thought,

[00:32:24] Speaker 04:
The original label says Hetlios.

[00:32:27] Speaker 04:
It cannot say Hetlios on the generic label for obvious reasons.

[00:32:35] Speaker 04:
It's different from Hetlios and they can't use Hetlios.

[00:32:39] Speaker 04:
So they have to put something because it's distributed by a different manufacturer.

[00:32:45] Speaker 04:
And so they've chosen to put Tazamalti on, but that is a generic

[00:32:51] Speaker 04:
Name.

[00:32:53] Speaker 04:
So I guess.

[00:32:56] Speaker 04:
What else could they have put there?

[00:32:58] Speaker 04:
They could have, I guess, come up with a name for their generic drug, but they're not required to do that.

[00:33:02] Speaker 06:
Well, they can't, Your Honor.

[00:33:03] Speaker 06:
Under other aspects of the statute and regulations, what Hetlios is, the brand product has a brand name for the active ingredient.

[00:33:11] Speaker 06:
The active ingredient is tazamaltine.

[00:33:14] Speaker 06:
When the generics come with their anda, they have to put on their bottle tazamaltine.

[00:33:20] Speaker 04:
Okay.

[00:33:20] Speaker 04:
And what did the other one?

[00:33:22] Speaker 06:
Apotex puts Tazimelt in.

[00:33:23] Speaker 04:
They all put Tazimelt in.

[00:33:25] Speaker 06:
Because that's the generic name, Your Honor, and that's what FDA required.

[00:33:29] Speaker 04:
Teva and Apotex, they- That does show that they're different from Vanda, but that doesn't show that they're different from each other.

[00:33:34] Speaker 06:
What somebody realizes is this is a generic product.

[00:33:37] Speaker 06:
They're getting the generic version.

[00:33:38] Speaker 06:
It does not distinguish which of the three different generics that are in the marketplace.

[00:33:44] Speaker 06:
That's right.

[00:33:44] Speaker 04:
So it does show it's a different manufacturer, but not a different manufacturer.

[00:33:48] Speaker 06:
You are not getting the branded products.

[00:33:50] Speaker 06:
You're not generics.

[00:33:51] Speaker 01:
Yes.

[00:33:51] Speaker 01:
But that's not showing different manufacturer even.

[00:33:55] Speaker 01:
Well, it's showing that it is a, it says you're not getting the name brand.

[00:33:59] Speaker 01:
Product that's all it shows because in fact, they don't know and this could matter if there's an active ingredients that someone has an allergy to they don't know whether they're getting the one or the one or the MSN one because none of those.

[00:34:16] Speaker 06:
Well, your honor, let me be clear.

[00:34:18] Speaker 06:
Vanda is in favor of more braille on the labels.

[00:34:20] Speaker 01:
Really?

[00:34:20] Speaker 01:
Have you put more braille on your labels?

[00:34:22] Speaker 06:
Your honor, we're the first company to ever ask to put this on.

[00:34:25] Speaker 01:
But you said you want more.

[00:34:26] Speaker 01:
So are you saying if the generic here had put everything in braille, that would be same?

[00:34:33] Speaker 06:
Well, your honor, I don't know if it would be same under PLEVA because PLEVA says going safer doesn't make it same.

[00:34:38] Speaker 01:
Exactly.

[00:34:39] Speaker 01:
So you said you're in favor of everyone doing it, but they can't do more.

[00:34:42] Speaker 01:
Your honor, I was just... Wait, but you can't be more safe.

[00:34:47] Speaker 01:
They're going to put an active ingredient in a way that is now accessible to those who read Braille and are blind that your label does not.

[00:34:58] Speaker 01:
And so.

[00:35:00] Speaker 01:
Would FDA have to say, I mean, it feels to me like there's a plea for problem with what you now want in Braille.

[00:35:10] Speaker 01:
If you said you've got to put Teva or Apotex or MSN in Braille, then at least that would be required because they're a different manufacturer.

[00:35:23] Speaker 06:
So just to start from basic points, just because this is important to put on the record, our company is the first one to put Braille on the label.

[00:35:29] Speaker 06:
So the suggestion that we should put more on the label, I don't think we disagree with.

[00:35:33] Speaker 06:
But we're the ones who are trying to move directionally to put Braille on the label.

[00:35:36] Speaker 06:
And FDA is saying, we don't need to have Braille on the label.

[00:35:40] Speaker 01:
Your name, your name brand on there.

[00:35:42] Speaker 01:
But you never put the active ingredient on.

[00:35:44] Speaker 06:
But we're trying to put in the essential information so a blind patient can understand, read their medication.

[00:35:49] Speaker 01:
Main brand advertising your name is more important than the active ingredient?

[00:35:57] Speaker 01:
Is the name your name brand more important than the active ingredient?

[00:36:02] Speaker 01:
I think that's what you just said.

[00:36:03] Speaker 01:
Is that correct?

[00:36:04] Speaker 06:
Well, let me be clear here.

[00:36:05] Speaker 06:
How drugs are advertised in this country is the name brand is what everybody knows the drug as.

[00:36:10] Speaker 06:
People generally don't know the generic name.

[00:36:12] Speaker 01:
I'm asking you a question.

[00:36:15] Speaker 01:
I mean, look, we're now well into there being generics on the market here.

[00:36:18] Speaker 01:
And I thought I heard you just say that having your name brand in Braille is more important to people who will only get information by using Braille.

[00:36:33] Speaker 01:
than telling them what the active ingredient is they're about to take.

[00:36:36] Speaker 06:
Can I answer this because this is important.

[00:36:39] Speaker 06:
I want to be very clear because I don't want to suggest that there's some more importance in marketing or something like that because that's not the case whatsoever.

[00:36:47] Speaker 06:
What is the case is that

[00:36:48] Speaker 06:
when a brand launches a drug, this isn't Hetlios, this is any drug, what you see on the packaging is generally the big splashy brand name, that is what is in big script, that's the Ozempic, it's whatever the answer is, and that's what the population, the doctor says, I'm going to prescribe you Hetlios, I'm going to prescribe you Ozempic, whatever it is, that is what the doctor tells the patients generally they are prescribing.

[00:37:13] Speaker 01:
So there are generics on the market, that's during your exclusivity period.

[00:37:16] Speaker 06:
And that's why a change required instead of having the big banner that says Hetlios on the label, it instead has the big banner that says Tazamaltine on the label and the doctor tells the patient, well, now it's generic.

[00:37:27] Speaker 06:
And so Hetlios is the generic version is called Tazamaltine because that's the active ingredient.

[00:37:33] Speaker 06:
But that's, again, what I'm trying to say is that is how the drug marketing world works.

[00:37:38] Speaker 01:
I understand that name brands have brands.

[00:37:43] Speaker 01:
I understand that.

[00:37:45] Speaker 01:
I am trying to ask a much simpler question since you brought it up and you've said it's really important and I agree it could be here and mine is seems very different to me to have a name brand in Braille but not a

[00:38:04] Speaker 01:
active ingredient on one label and then the other one to have the active ingredient in Braille but not the manufacturer's identity.

[00:38:14] Speaker 01:
I mean the reality is on your brand there's two ways to find the manufacturer identity, name brand or Vanda, both of which are on the label.

[00:38:22] Speaker 01:
And there's only one way for them and you're the one who said it has to be required by being a new manufacturer and that require changes.

[00:38:29] Speaker 01:
It can't say Vanda.

[00:38:31] Speaker 01:
It has to say to have a text.

[00:38:35] Speaker 01:
I just want to remind you that those have to be in italics.

[00:38:39] Speaker 06:
Even if I'm wrong about all of this, just to be clear again, this doesn't say anything about the 20-milligram issue.

[00:38:43] Speaker 06:
And so the key statutory question we put before the court still exists with respect to that.

[00:38:49] Speaker 06:
But coming back to this, I think this is, Candidly Judge Pan did a better job retaking my argument than I did.

[00:38:54] Speaker 06:
But it's the point that what has to be the same is the brailness, because that's what's there.

[00:39:00] Speaker 06:
But that gets married to a change required.

[00:39:04] Speaker 01:
So the braille miss, I'm not even sure if that means that you want some braille on the label.

[00:39:11] Speaker 01:
But maybe I didn't.

[00:39:13] Speaker 01:
They just had 20 MG in braille.

[00:39:17] Speaker 01:
What would your position be?

[00:39:19] Speaker 06:
If it was just 20 MG in braille, our position would be the same position.

[00:39:22] Speaker 06:
It needs to be the same so the patient knows that this is 20 MG.

[00:39:26] Speaker 06:
And this will tell the patient.

[00:39:28] Speaker 01:
I'm sorry, I wasn't clear.

[00:39:29] Speaker 01:
So if Tava had come along and said,

[00:39:34] Speaker 01:
We can't put an active ingredient in braille.

[00:39:38] Speaker 01:
That would be an increase in safety if you believe that braille increases safety.

[00:39:42] Speaker 01:
So we can't do that.

[00:39:47] Speaker 01:
So we're just going to put the 20MG in Braille.

[00:39:52] Speaker 01:
And what would your position be as to whether that satisfies the same label requirement?

[00:39:57] Speaker 06:
We would say it does not.

[00:39:58] Speaker 06:
But I appreciate, from your honor's line of suggested questioning, that may be a harder question for us.

[00:40:04] Speaker 06:
But I would still say it does not.

[00:40:06] Speaker 01:
And you would say it does not because they have to have more Braille on there?

[00:40:12] Speaker 06:
Can I just go back to the example of the main label itself?

[00:40:17] Speaker 06:
So our label says in big, large letters, Hetlios.

[00:40:20] Speaker 06:
They can't say Hetlios, but they do have to say in big, large letters, change required, Tazmeltian, because that's the generic name of this.

[00:40:28] Speaker 01:
Did you have to say on your label Tazmeltian?

[00:40:32] Speaker 06:
in very small script that's underneath it, not in the large letter font that is prominent to the patients.

[00:40:40] Speaker 02:
So I'm looking at, let's see whose brief this is.

[00:40:45] Speaker 02:
That 13 picture of the label and under the brand name is the active ingredient, not in Braille.

[00:41:01] Speaker 06:
Yes, Your Honor.

[00:41:02] Speaker 02:
It is not.

[00:41:03] Speaker 06:
It is not in Braille.

[00:41:04] Speaker 06:
What is in Braille is Hetlios and then 20 milligrams.

[00:41:06] Speaker 02:
That's right.

[00:41:07] Speaker 02:
I just wanted to be clear.

[00:41:08] Speaker 06:
Yes.

[00:41:09] Speaker 02:
And let me say the reason I'm not clear is because at least on page 13, the MG, the two in 20,

[00:41:25] Speaker 02:
is lettered in Braille, but not the zero MG.

[00:41:30] Speaker 02:
But you're saying all that is Braille, and the only thing that's not Braille is what's in, what, the chasmillion and the word capsules?

[00:41:42] Speaker 06:
Yes, your honor.

[00:41:44] Speaker 02:
Okay.

[00:41:44] Speaker 02:
Wait, wait.

[00:41:45] Speaker 06:
No, 20 mg is in Braille.

[00:41:47] Speaker 06:
Sorry.

[00:41:47] Speaker 06:
Hetlios is in Braille and 20 mg is in Braille.

[00:41:50] Speaker 06:
I apologize if I misheard something.

[00:41:51] Speaker 02:
No, right.

[00:41:52] Speaker 02:
That's what we were just saying.

[00:41:54] Speaker 02:
All right.

[00:41:54] Speaker 02:
But I'm just telling you, the picture here doesn't give that sense because some parts of the... When I looked at this, I thought, well, not all of

[00:42:04] Speaker 02:
The dosage is in Braille, but that's wrong.

[00:42:06] Speaker 02:
Then what's below all this?

[00:42:10] Speaker 06:
This might be confusing.

[00:42:11] Speaker 06:
Let me explain.

[00:42:12] Speaker 06:
This below, what this is depicting is a clear sticker that is overlaid on the label.

[00:42:17] Speaker 06:
And the above image shows what it looks like with that sticker attached.

[00:42:23] Speaker 06:
So the way that this works is you have the bottle, you have one sticker that is the Roman language, and then you have a second clear sticker that has braille that gets affixed on top of it.

[00:42:35] Speaker 02:
And so this bottom... It's just a copy of what's on the top.

[00:42:38] Speaker 06:
Yes, Your Honor.

[00:42:39] Speaker 06:
It's showing just the braille standing alone.

[00:42:40] Speaker 02:
Thank you.

[00:42:42] Speaker 04:
So why isn't it the case that your label is your label?

[00:42:46] Speaker 04:
It's been approved by the FDA.

[00:42:51] Speaker 04:
gone through a rigorous process to get it approved, which is why generics are supposed to have the same label to piggyback off that approval process.

[00:43:00] Speaker 04:
Your label doesn't have tazamaltion in braille, and the word required doesn't go to what's required at that point.

[00:43:09] Speaker 04:
Your label is just your label.

[00:43:11] Speaker 04:
It just has hetleos and 20 milligrams in braille.

[00:43:15] Speaker 04:
And then to apply this statutory provision,

[00:43:18] Speaker 04:
It has to be the same except for the changes that are required because the new drug and listed drug are produced or distributed by different manufacturers.

[00:43:29] Speaker 04:
The new drug has to say something other than Hetlios.

[00:43:34] Speaker 04:
So it says Tazamaltion, which is the generic version of Hetlios.

[00:43:39] Speaker 04:
And that needs to be in Braille because the fact

[00:43:43] Speaker 04:
that the identifying name is in Braille does not need to be changed because it's a different manufacturer.

[00:43:49] Speaker 04:
The use of Braille does not need to be changed because it's a different manufacturer.

[00:43:55] Speaker 04:
But what is said in Braille needs to be changed because it can't be Hellios, because it's a different manufacturer.

[00:44:00] Speaker 04:
They can't use Hellios.

[00:44:02] Speaker 04:
And it uses the generic brand because it shows that this is the same as Hellios, but it's the generic version.

[00:44:10] Speaker 04:
And it has to have 20 milligrams in Braille.

[00:44:13] Speaker 04:
So why doesn't that comply with the statute?

[00:44:16] Speaker 06:
So, Your Honor, if I can compare page 13 that Judge Rogers pointed to, to page 17, which is Teva's label, what you see is in our label, you have the large script, which says Hetlios, and on page 17,

[00:44:31] Speaker 06:
It's no surprise that what you have here is enlarged script has a melting capsules because that's the generic name of the product that has to be enlarged script.

[00:44:41] Speaker 06:
So the change required is taking what is the very small script and is telling the active ingredient and turning it into the label of the product.

[00:44:51] Speaker 06:
The headline thing that somebody sees when they pick up our product is Helios.

[00:44:55] Speaker 06:
The change that must be required, because you have to have the headline thing, the label of the product, that's FDA required.

[00:45:01] Speaker 06:
It now changes to tazamaltine capsules.

[00:45:03] Speaker 06:
That is a change that has been required from one label to another label.

[00:45:09] Speaker 04:
But the change from Braille is not black.

[00:45:11] Speaker 06:
And so my point, though, is they could not have, if you look on the left side where you have, where it says usual dosage, they could not legally have Tazimeltian capsules in script that looks like that, that's not prominent, that does not tell the user what it is.

[00:45:27] Speaker 06:
They have to replace Hetlios with Tazimeltian.

[00:45:31] Speaker 06:
That is a change that is required.

[00:45:32] Speaker 01:
Is that part of the same label requirement that they have to do that, or is it separately required by a

[00:45:36] Speaker 06:
Well, I think it's both the same label, but also as part of FDA's regulations.

[00:45:41] Speaker 01:
You think it's the same label.

[00:45:42] Speaker 01:
FDA may not, because they separately require that you have it.

[00:45:46] Speaker 01:
Do they require you to reveal the active ingredient on your label, too?

[00:45:50] Speaker 06:
Yes, Your Honor.

[00:45:51] Speaker 01:
Do they require your name brand to be a certain size?

[00:45:53] Speaker 06:
I think they do, Your Honor.

[00:45:54] Speaker 06:
I can go back and look at this.

[00:45:55] Speaker 06:
But there has to be essentially a headline of what this product is, and it has to be of sufficiently prominent font.

[00:46:01] Speaker 01:
But you've been chosen to have

[00:46:03] Speaker 01:
Tasmeltian, just like these folks do, is the big name.

[00:46:07] Speaker 01:
And then your name brand in this very small print that you have the active ingredient.

[00:46:14] Speaker 06:
I actually don't know if we could, Your Honor.

[00:46:15] Speaker 06:
I can look into that and give the Court a 28-J, if useful.

[00:46:18] Speaker 06:
But I don't know standing here if we can do that, consistent with FDA's labeling requirements.

[00:46:24] Speaker 06:
I just genuinely don't know, Your Honor.

[00:46:25] Speaker 01:
But Tasmeltian is not.

[00:46:28] Speaker 01:
It is the name of.

[00:46:30] Speaker 01:
to make medication.

[00:46:32] Speaker 01:
That's what a generic does.

[00:46:33] Speaker 01:
It does the name of the medication, the active ingredient in the medication.

[00:46:39] Speaker 01:
And all the generics have that exact same name.

[00:46:42] Speaker 01:
So unlike helio, am I saying heliox?

[00:46:46] Speaker 03:
Helios, sorry.

[00:46:50] Speaker 01:
Which identifies manufacturer, company, brand.

[00:46:57] Speaker 01:
use of this generic active ingredient does not.

[00:47:01] Speaker 01:
As I said, it doesn't tell somebody who the manufacturer is, correct?

[00:47:06] Speaker 06:
But the point I'm making is this label has to have a headline.

[00:47:12] Speaker 06:
And our headline is in Braille.

[00:47:14] Speaker 06:
Their headline is not in Braille.

[00:47:15] Speaker 06:
The way to keep it the same is you keep the headline in Braille because that's what we've done.

[00:47:20] Speaker 06:
The change required is just as the Roman text of the headline has to change from Helios to Thasimeltian, the label

[00:47:28] Speaker 06:
The Braille text changes from Hetlios to Tazimeltian.

[00:47:32] Speaker 01:
Again, though, that says you have to have a headline if you're a name brand that is not the active ingredient.

[00:47:41] Speaker 06:
I believe that's the case, but I can confirm I do not know if we could have inverted Hetlios and Tazimeltian on this.

[00:47:47] Speaker 06:
I don't think that would change the nature of my argument.

[00:47:50] Speaker 01:
Well, then.

[00:47:51] Speaker 01:
we'd have maybe sameness on what's in Braille.

[00:47:53] Speaker 01:
But can I ask, I just have a real quick question while we're on page 17.

[00:47:59] Speaker 01:
You have on top the approved label and then on the bottom you have the publicly available label.

[00:48:04] Speaker 01:
Currently uses.

[00:48:06] Speaker 01:
So this is just, this really doesn't go to any of the arguments here.

[00:48:09] Speaker 01:
I was just very confused.

[00:48:12] Speaker 01:
I would have thought the approved label would have to be the publicly used

[00:48:17] Speaker 06:
So there's an answer.

[00:48:19] Speaker 01:
What are we comparing to for purposes of sameness here?

[00:48:23] Speaker 06:
Your honor, I'm not sure that there is a well, I think we are looking to the approval label.

[00:48:29] Speaker 06:
That is what FDA was considering.

[00:48:31] Speaker 06:
But what's changed, for example, the NDC code is the has changed.

[00:48:38] Speaker 06:
And again, I don't know the precise history of other changes, but it's like no lot and expiration here.

[00:48:45] Speaker 01:
There's no.

[00:48:46] Speaker 01:
swish sort of the trade.

[00:48:48] Speaker 01:
I assume that's a kind of trademark thing for for Teva.

[00:48:54] Speaker 01:
But I'm just I just don't even know what we're what we're comparing here.

[00:48:59] Speaker 01:
It's just it's just sort of baffling to me.

[00:49:01] Speaker 01:
So but it's true that you can have you can change things from what they've approved.

[00:49:08] Speaker 06:
Yeah, I think it's a difference between the tentative approval and final approvals.

[00:49:11] Speaker 06:
But again,

[00:49:13] Speaker 01:
That's not what you said, though, the approved label.

[00:49:15] Speaker 01:
When you say approved label, did you mean tentatively approved?

[00:49:18] Speaker 06:
Your Honor, I'd have to go check and see and understand what... I don't want to distract.

[00:49:21] Speaker 01:
It was really confusing.

[00:49:22] Speaker 02:
No, but it's just confusing to figure out what we're doing here.

[00:49:25] Speaker 02:
But what we have looked at, Your Honor, is the label that... You want us to look at, compare the label on page 13, which is yours, your client's, and the label at the bottom of page 17.

[00:49:39] Speaker 06:
Or top, but you're I think bottom.

[00:49:42] Speaker 01:
Thank you.

[00:49:42] Speaker 01:
Yes, which one am I comparing it to?

[00:49:44] Speaker 06:
Yeah, I'm going to pick top because that's what FDA was looking at when they granted approval.

[00:49:49] Speaker 06:
And so I think that is turning on what the legal determination was.

[00:49:52] Speaker 06:
Was there was that label?

[00:49:54] Speaker 06:
But again, we were trying to be most complete, but I don't think there's a for our purposes.

[00:50:00] Speaker 02:
I get it, but just so we know what we're doing.

[00:50:03] Speaker 02:
All right.

[00:50:04] Speaker 06:
Yes.

[00:50:06] Speaker 06:
Again, first, again, we've talked about this doesn't go to 20 milligram, but if I can just for a brief moment, I know I'm well over my time.

[00:50:14] Speaker 06:
The essential point though that we make about statutory construction is for both the principal rule and the word required to do work, the change required has to be caused by something

[00:50:26] Speaker 06:
external to the label itself.

[00:50:28] Speaker 06:
There has to be some permissible change that FDA or that the generic is allowed to make, such as different inactive ingredient, different indication, the subset of indications.

[00:50:40] Speaker 01:
It can't simply be.

[00:50:42] Speaker 01:
Please recycle.

[00:50:44] Speaker 06:
Please recycle.

[00:50:45] Speaker 01:
Please recycle.

[00:50:48] Speaker 06:
Probably not.

[00:50:50] Speaker 06:
I don't know.

[00:50:50] Speaker 01:
Well, they can put kosher.

[00:50:54] Speaker 06:
Well, kosher is describing what the manufacturing process is.

[00:50:57] Speaker 01:
I mean, assume that they're identical manufacturing processes.

[00:51:01] Speaker 01:
They just, for whatever reason, want to let people know are vegan.

[00:51:05] Speaker 01:
Contents are the same.

[00:51:06] Speaker 01:
We know they have to be the same.

[00:51:08] Speaker 01:
And I'm assuming for here inactive ingredients are the same.

[00:51:10] Speaker 01:
And so they want to put vegan or vegan friendly.

[00:51:13] Speaker 06:
If I would.

[00:51:14] Speaker 06:
Think, Your Honor, that the answer would be it needs to be the same.

[00:51:17] Speaker 06:
So if the product is truthfully described, it's not false or misleading.

[00:51:21] Speaker 06:
It should copy.

[00:51:23] Speaker 06:
Yes, I mean, it's the same misrequirement.

[00:51:24] Speaker 06:
I don't think there's anything surprising that if the generic drug is the same.

[00:51:28] Speaker 01:
It's not identity.

[00:51:28] Speaker 01:
And you've said we pre-dress things and the minimus things.

[00:51:32] Speaker 01:
They can communicate things.

[00:51:34] Speaker 01:
We know that you have to print warnings about children.

[00:51:36] Speaker 01:
Is yours keep out of reach of children?

[00:51:38] Speaker 01:
They just keep all medicines out of reach of children.

[00:51:40] Speaker 01:
Was that a violation too?

[00:51:42] Speaker 01:
Is that a difference in violation?

[00:51:43] Speaker 01:
Am I right?

[00:51:44] Speaker 01:
They say keep all, tell me if I've got it backwards.

[00:51:46] Speaker 01:
I think Teva says keep all medicines, all medicines away from children.

[00:51:51] Speaker 01:
And your label says keep this medicine away from children.

[00:51:55] Speaker 06:
That's where I go back to there might be single word distinctions that are trifles.

[00:52:00] Speaker 06:
And that could be, I think the answer the court would say.

[00:52:02] Speaker 01:
I think the problem here is what you're willing to call deminism or stylistic.

[00:52:13] Speaker 01:
Right?

[00:52:13] Speaker 01:
They've got the swish mark on theirs.

[00:52:16] Speaker 01:
Others might say fonts.

[00:52:21] Speaker 01:
I thought you actually would agree that font is a style they can change.

[00:52:24] Speaker 01:
We don't require that they do that.

[00:52:26] Speaker 01:
Their Telementean is not in the same font or size as Heliox is.

[00:52:31] Speaker 06:
Again, this is where I want to go back to.

[00:52:33] Speaker 06:
This is not an issue that is dealt with by the exception, the change required.

[00:52:37] Speaker 06:
This is an issue, that line of question, which is an important one, goes to, is it a violation of the sameness requirement?

[00:52:46] Speaker 02:
I thought you had agreed, though, and maybe I misunderstood, that the way you're interpreting the statutory text, sameness, is not a requirement

[00:53:02] Speaker 02:
that the labels be identical.

[00:53:04] Speaker 06:
It's not a carbon copy requirement, that's right.

[00:53:06] Speaker 02:
That's right.

[00:53:07] Speaker 02:
So from FDA's perspective, just hypothetically, they look at your label and all I know as a blind person is if I put my hand out and feel the bottle, I feel some Braille, right?

[00:53:25] Speaker 06:
Yes, you do feel the Braille, that's right.

[00:53:29] Speaker 06:
And the form factor of the bottle as well, which is unique.

[00:53:32] Speaker 02:
Right, but the forum, okay.

[00:53:35] Speaker 02:
But what I'm getting at, and I thought this is what Judge Millett's questioning was getting at, is from FDA's perspective, we want the public to be clear that the generic is, quote, the same as the pioneer drug, and yet,

[00:54:01] Speaker 02:
The same that's an issue and important for health and safety is the active ingredient.

[00:54:13] Speaker 02:
So if I'm looking at your label, that's in very small type.

[00:54:18] Speaker 02:
If I'm looking at the generic label, it's in bold type, larger type, right?

[00:54:26] Speaker 02:
Why, from FDA's perspective of safety, et cetera, you say there is, I mean, the FDA record that you cite on whether they think Braille has anything to do with safety is about as wishy-washy as you can get, all right?

[00:54:49] Speaker 02:
And so

[00:54:52] Speaker 02:
I just thought from the point of view of the concern about safety and health, having the active ingredient in larger, and in this case, bowl type, provides more safety than knowing that the pioneer

[00:55:13] Speaker 02:
His name is Helios.

[00:55:14] Speaker 02:
I want to take us back to the statutory text because- I am with you on statutory text, but I'm trying to understand what did Congress mean when it used these words, all right?

[00:55:27] Speaker 02:
And it was concerned, as I understood it, that marketing of new drugs was too costly.

[00:55:35] Speaker 02:
It was too time consuming.

[00:55:37] Speaker 02:
It took years upon years upon years.

[00:55:41] Speaker 02:
All right?

[00:55:42] Speaker 02:
So once they had a pioneer that was approved, they wanted to get these generics out faster.

[00:55:48] Speaker 02:
All right?

[00:55:49] Speaker 03:
Precisely.

[00:55:50] Speaker 02:
So the generics could piggyback on the pioneer's research.

[00:55:56] Speaker 02:
And it could change the label, just so the generics told the consuming public what the generic was.

[00:56:06] Speaker 06:
I agree with all of that, your honor, and that's why I don't think what what Congress set up leaves room for what FDA is ultimately requesting, which is the A's delegated the authority to determine what is necessary for safe consumption.

[00:56:22] Speaker 02:
Right.

[00:56:23] Speaker 02:
But the manufacturers.

[00:56:24] Speaker 06:
Yes, Your Honor, but that's not part of the ANDA approval process is a principal matter for the labeling.

[00:56:30] Speaker 06:
Because the way Congress set it up to streamline it, to get to exactly what Your Honor was saying is, we've already done the safety and efficacy approval.

[00:56:37] Speaker 06:
We've already done the labeling.

[00:56:38] Speaker 02:
No, but here's my point.

[00:56:40] Speaker 02:
The approved label, I understand that.

[00:56:43] Speaker 02:
And I thought that was going to be your lead argument.

[00:56:45] Speaker 02:
But in any event, suppose.

[00:56:48] Speaker 06:
Well, I'm trying to make it, Your Honor.

[00:56:49] Speaker 06:
Hopefully I'm there.

[00:56:50] Speaker 06:
But.

[00:56:50] Speaker 02:
Suppose Teva.

[00:56:53] Speaker 02:
put out a label that was exactly like yours.

[00:56:59] Speaker 02:
All right, it says Helios.

[00:57:02] Speaker 02:
All right, and then it has the active ingredient.

[00:57:07] Speaker 06:
They can't, and that's why Congress.

[00:57:08] Speaker 02:
No, they cannot.

[00:57:10] Speaker 06:
That's right.

[00:57:10] Speaker 02:
And so that's why there's that provision in the statute.

[00:57:13] Speaker 06:
Precisely.

[00:57:15] Speaker 02:
If there's a manufacturing change, et cetera.

[00:57:18] Speaker 02:
So they can't put your name on their label.

[00:57:21] Speaker 06:
That's right, it's a change required.

[00:57:23] Speaker 06:
I totally agree.

[00:57:25] Speaker 02:
So I don't see why it's not reasonable if you're delegating authority to an agency with expertise and they have to make a decision about how can this generic be safely administered and understood

[00:57:48] Speaker 02:
that it couldn't make that decision that, well, it's very nice that the pioneer decided to use some of his label in Braille.

[00:58:01] Speaker 02:
And that's probably very convenient for blind people, all right?

[00:58:06] Speaker 02:
But on the other hand, what we really want them to be clear about is it's the same active ingredient.

[00:58:12] Speaker 02:
So that's why what we want is this bold,

[00:58:19] Speaker 02:
Why?

[00:58:20] Speaker 06:
Your honor, those points might go to my arbitrary and capriciousness arguments.

[00:58:24] Speaker 02:
No, I'm not there.

[00:58:25] Speaker 02:
I'm with your concession.

[00:58:26] Speaker 02:
That sameness doesn't mean identical.

[00:58:29] Speaker 06:
But it does not mean, though, that they can change things, that we're specifically negotiating a really important part of the label, where we had to go out and do study requirements to be able to demonstrate the readability of this, where we went and said, this is done in Europe.

[00:58:43] Speaker 02:
I understand that.

[00:58:44] Speaker 02:
And maybe we're just behind Europe.

[00:58:46] Speaker 02:
I thought that was a very nice point.

[00:58:48] Speaker 02:
OK.

[00:58:48] Speaker 02:
But anyway, that's where we are.

[00:58:50] Speaker 02:
And my only point is that if there is some delegated authority here, isn't that precisely the type of delegation

[00:59:02] Speaker 02:
decision that was intended.

[00:59:05] Speaker 06:
When you look at the citizens petition, their response, there is no discussion from FDA that describes in some rigorous fashion what change required means.

[00:59:15] Speaker 06:
What FDA essentially says is we'll just use our judgment and decide, but that's not the statute Congress wrote.

[00:59:21] Speaker 06:
That would mean that the sameness requirement is essentially, doesn't actually have the force Congress intended that anything could change.

[00:59:29] Speaker 06:
And PLEVA says that is not right.

[00:59:31] Speaker 06:
Even if it would be a great idea for a generic to add more safety information that doesn't conflict with the label, that just adds more information on top that would be great for the public, the Supreme Court says you can't do that.

[00:59:44] Speaker 06:
That is not part of the Hatch-Waxman bargain.

[00:59:49] Speaker 01:
Well, so when they have tasmaltium in bold, thicker print, and the 20MG highlighted by this orange background, those are impromptu?

[01:00:05] Speaker 06:
No, we've not argued that those are impromptu.

[01:00:07] Speaker 01:
You haven't argued those, but those are different.

[01:00:09] Speaker 01:
And those would seem to be highlighting, as Judge Rogers said, critically important information.

[01:00:17] Speaker 01:
I have to search around on here for where the active ingredient is, right?

[01:00:22] Speaker 01:
I mean, mom, so.

[01:00:24] Speaker 06:
This is where I go back to my underlying point where I grew with Judge Rogers.

[01:00:29] Speaker 06:
These are not carbon copy photocopy requirements.

[01:00:32] Speaker 01:
I'm just trying to clear up something.

[01:00:33] Speaker 01:
So I just want to make sure I know.

[01:00:34] Speaker 01:
Do you agree that this font change and there's a bolding change?

[01:00:43] Speaker 01:
Are permissible.

[01:00:45] Speaker 01:
Yes, because I don't think it makes it not the same label for legal purposes and boldness changes are now.

[01:00:54] Speaker 06:
It was an accepted premise of the citizens petition that these aren't the same that the citizens petition, which we have to accept, generally said we have to get into the exception.

[01:01:02] Speaker 01:
Okay, I'm just so font.

[01:01:10] Speaker 01:
formatting, shading, that's, at least is what's done here.

[01:01:15] Speaker 01:
I'm sure one can imagine.

[01:01:17] Speaker 06:
But that's the thing.

[01:01:17] Speaker 06:
I'm not saying these are subject to categorical rules because one can imagine font or shading not being the same.

[01:01:24] Speaker 06:
And there could be tough judgment calls, but that's not here.

[01:01:26] Speaker 01:
Let's imagine there's a medicine for dyslexia.

[01:01:29] Speaker 06:
For sure.

[01:01:30] Speaker 01:
It turns out.

[01:01:31] Speaker 06:
Yeah, there's some fonts that are easier for dyslexia.

[01:01:33] Speaker 01:
Right, there are fonts that are like that.

[01:01:35] Speaker 01:
So if a generic comes along and says,

[01:01:39] Speaker 01:
And let's assume there's the name brand and it just has regular font.

[01:01:43] Speaker 01:
And the generic comes along and says, well, no, we're going to use a font that's easier for those who are dyslexic to read.

[01:01:53] Speaker 01:
We'll have the same content.

[01:01:55] Speaker 01:
I mean, other than the stuff we have to change like name.

[01:01:58] Speaker 01:
We'll have the same content, but we're going to have that different font because it's easier to be read by dyslexic patients.

[01:02:05] Speaker 01:
Leave a permits or doesn't.

[01:02:07] Speaker 06:
You know, I think that's a hard question or plea of it because that is your view.

[01:02:11] Speaker 01:
I wouldn't be asking if I thought it were an easy question.

[01:02:14] Speaker 01:
If the font changes.

[01:02:20] Speaker 06:
I think that probably the best reading of PLEVA is that it prohibits it.

[01:02:24] Speaker 06:
I admit that's a tough call.

[01:02:26] Speaker 06:
The reason it prohibits it is because the reason you'd be doing the font change is because you're saying it makes a difference.

[01:02:32] Speaker 06:
I know that's a counterintuitive result.

[01:02:34] Speaker 06:
It's the same way that PLEVA says you can't make the product safer.

[01:02:37] Speaker 06:
But I think it would be a pretty good reason for the generic to petition the FDA to say, we've got a better way to do this label, and you should compel the branded product to use this label.

[01:02:48] Speaker 04:
That change would not be required because it was a different manufacturer.

[01:02:52] Speaker 06:
Well, they could petition FDA to change the branded manufacturers label, and then it would come downstream from there that they could use that.

[01:03:00] Speaker 04:
But again, am I wrong?

[01:03:01] Speaker 04:
That's looking at a different.

[01:03:03] Speaker 04:
Part of the statute, whether it's same or not, whereas.

[01:03:07] Speaker 04:
We're trying to look at whether it's required because it's different manufacturer changing a thought to make it better.

[01:03:14] Speaker 04:
or more easily read by dyslexic people would not be a change that's required because you're a manufacturer.

[01:03:22] Speaker 06:
That's right.

[01:03:22] Speaker 06:
Different manufacturer.

[01:03:23] Speaker 06:
Sorry, Your Honor.

[01:03:24] Speaker 06:
I think if the hypothetical is the generic says we have a better way to do the label that is going to be more useful for the patient population who's going to take this product, and we're going to petition FDA to change the brand products label, FDA says, you know, you're right, that's a better way to do the label.

[01:03:42] Speaker 04:
So we change both labels and still be the same.

[01:03:44] Speaker 06:
It would still be the same because it would change the brand label and then that would flow through from the requirements to the generic.

[01:03:51] Speaker 06:
That's right.

[01:03:53] Speaker 06:
Let me be clear.

[01:03:54] Speaker 04:
It's this case is conceded that these are different.

[01:03:57] Speaker 04:
They're not the same and we're only looking at whether the change is required because it's.

[01:04:03] Speaker 04:
A different manufacturer, right?

[01:04:05] Speaker 06:
And I'll point the court just to 2 places in the citizen petition response because I think that's pretty well cements FDA's position.

[01:04:11] Speaker 06:
It's J 920 and 918 and they J 20 acknowledge the quote unquote labeling differences between the RLD.

[01:04:19] Speaker 06:
That's the reference listed drug in the and as.

[01:04:21] Speaker 06:
and then 918 make clear the sole legal argument they're resting on is are we within the scope of the changes required exception not are we in a world which we say that these are legally the same labels and again i don't actually didn't do that so they can't from a general perspective but i don't think it would be well taken if they said braille or no braille is the kind of thing where it's

[01:04:44] Speaker 06:
you know, a small font, your honor's font change where there's actually a somebody can read it better.

[01:04:49] Speaker 06:
That might be a distinct case, but just a, you know, a slightly bigger, slightly smaller, you know, different color, I don't think is nearly the same as Braille or not Braille.

[01:04:58] Speaker 06:
So that's why FDA didn't make that argument in the below when it was before the agency.

[01:05:03] Speaker 02:
No role for FDA's expertise in the determination of what is required.

[01:05:13] Speaker 06:
Well, I think that's what the Supreme Court in Pliva said is this requirement is pretty strong and we're not going to go back.

[01:05:20] Speaker 06:
The plaintiffs in the Pliva case said, of course, FDA would have allowed if you'd gone back and asked for safer information.

[01:05:27] Speaker 06:
And the Supreme Court says we can't engage in that sort of situation because what is required here is the same label.

[01:05:34] Speaker 06:
That's the strict obligation of it being the same label.

[01:05:38] Speaker 02:
You acknowledge the record evidence about how the Braille came into being, correct?

[01:05:46] Speaker 06:
I'm sorry, I'm not sure I follow your honor's question if you could.

[01:05:49] Speaker 06:
Well, maybe it wasn't there.

[01:05:54] Speaker 02:
Vanda said we'd like to add Braille.

[01:05:58] Speaker 02:
Yes, ma'am.

[01:05:59] Speaker 02:
And FDA said,

[01:06:02] Speaker 02:
That's interesting.

[01:06:03] Speaker 02:
Do some studies.

[01:06:04] Speaker 02:
Yes.

[01:06:05] Speaker 02:
All right, let's see if that's really going to be helpful or not.

[01:06:08] Speaker 02:
All right, so you did some studies.

[01:06:11] Speaker 02:
And some people thought it was helpful.

[01:06:12] Speaker 02:
Some people thought it wasn't.

[01:06:14] Speaker 02:
And then within the agency, you had three different people.

[01:06:17] Speaker 02:
And they had slightly different views.

[01:06:20] Speaker 02:
But no one thought, as I read it, and maybe I'm wrong, tell me if I'm wrong, that it was essential or necessary

[01:06:30] Speaker 02:
for the safe and effective administration of these drugs.

[01:06:35] Speaker 06:
But that isn't the question the statute asks because, for example, the same thing could be with warnings.

[01:06:41] Speaker 02:
So you say all I'm trying to understand in this case is I'm trying to understand what Congress had in mind.

[01:06:49] Speaker 06:
Can I give this example?

[01:06:52] Speaker 02:
Could I just finish?

[01:06:53] Speaker 02:
Then you can tell me how I'm wrong.

[01:06:55] Speaker 02:
First, we're looking at the plain text.

[01:06:58] Speaker 02:
All right?

[01:06:59] Speaker 02:
That's where you begin and end.

[01:07:01] Speaker 02:
All right?

[01:07:03] Speaker 02:
I'm saying sometimes words aren't always clear.

[01:07:09] Speaker 02:
So what does required mean?

[01:07:12] Speaker 02:
And suppose FDA said to your client, yeah, you know, if you want to issue

[01:07:21] Speaker 02:
I don't know, $50 U.S.

[01:07:24] Speaker 02:
bonds with every bottle of Helios, go right ahead.

[01:07:30] Speaker 02:
It's a great idea.

[01:07:31] Speaker 02:
You know, more blind people will use your product and it'll be good for them.

[01:07:35] Speaker 02:
Great.

[01:07:36] Speaker 02:
And that's what your studies show.

[01:07:39] Speaker 02:
So you put out these $50 bonds.

[01:07:43] Speaker 02:
Then a generic comes along and says, we don't want to put out those $50 bonds, all right?

[01:07:50] Speaker 02:
It's not required.

[01:07:52] Speaker 02:
It's great that you do it.

[01:07:55] Speaker 02:
Some people think it's really good for the blind community.

[01:07:59] Speaker 02:
But, you know, is it medically necessary for safety or the efficacy in the use of the drugs?

[01:08:09] Speaker 02:
And FDA says, essentially, no, go ahead.

[01:08:16] Speaker 02:
with the label that you're proposing.

[01:08:18] Speaker 06:
So let me offer an example I think plays off this because this could be a very real world example and I think it helps at least how we're thinking about this.

[01:08:28] Speaker 06:
Take the court's example of the history here.

[01:08:30] Speaker 06:
Imagine a scenario where you get all sorts of clinical data that could have warning signs about your drug having some sort of adverse events.

[01:08:38] Speaker 06:
Not for Hetlius, very safe drug, but I'm just saying hypothetically.

[01:08:40] Speaker 06:
So for some other drug and the brand may be very concerned about liability.

[01:08:44] Speaker 06:
So they go to FDA and say, here's some evidence that we think we need to put an extra warning on our products because of cardiovascular activity.

[01:08:53] Speaker 06:
And we want to do that because we don't want to get sued later.

[01:08:55] Speaker 06:
So we want to put this in our bottle.

[01:08:57] Speaker 06:
And the folks at FDA look at it and say, well, it's not really that big of a risk.

[01:09:00] Speaker 06:
There's maybe one or two people.

[01:09:01] Speaker 06:
It's not something that we would require generally to do because it's not so overwhelming.

[01:09:06] Speaker 06:
But if the brand wants to do it, sure, why not?

[01:09:08] Speaker 06:
It's truthful information.

[01:09:09] Speaker 06:
They can put it on the label.

[01:09:11] Speaker 06:
That's no problem.

[01:09:12] Speaker 06:
Generic comes around and says, we've looked at the sevens.

[01:09:15] Speaker 06:
We don't think it needs to go on the label.

[01:09:16] Speaker 06:
And you look at a record and it'd be the same record here.

[01:09:19] Speaker 06:
And they can say, well,

[01:09:20] Speaker 06:
The reviewers internally thought it was inconclusive.

[01:09:22] Speaker 06:
And I said, maybe it's nice to have, I'll let the brand do it.

[01:09:24] Speaker 06:
The result is they have to copy what the brand product did.

[01:09:28] Speaker 06:
And if they don't like what the brand product did, they have to change, go back and change the brand label through a petition process.

[01:09:35] Speaker 02:
Because you're changing your position, you think sameness means identical.

[01:09:42] Speaker 06:
I'm talking about things that are saying because they're actually conveying information that is, you know, has some substantive effect or is material information or something.

[01:09:51] Speaker 06:
And again, I'm not saying those are the precise test.

[01:09:53] Speaker 06:
I'm saying it's actually conveying things that FDA's- To what?

[01:09:57] Speaker 01:
Safety and efficacy?

[01:09:59] Speaker 06:
Well, no, I'm not suggesting this is a material.

[01:10:01] Speaker 06:
I'm saying it's something that matters.

[01:10:02] Speaker 01:
Is this the kind of material that I was picking up on?

[01:10:05] Speaker 06:
Yeah.

[01:10:05] Speaker 06:
And that's why I'm not suggesting that this is a just a straight materiality test.

[01:10:10] Speaker 06:
What I'm saying is sameness is, is there some reason that this matters?

[01:10:15] Speaker 01:
Because what we're trying to figure out is even you agree it's not identity.

[01:10:20] Speaker 01:
And you agree that there can be different within, I mean, there's extensive regulation by FDA on sizes and what's bold and whatnot, but within the rules, there can be difference on fonts, shading, highlighting.

[01:10:39] Speaker 01:
All of these things can do whatever else falls in your de minimis bucket.

[01:10:44] Speaker 01:
All of these things can happen as well.

[01:10:47] Speaker 01:
And FDA has put those in the different manufacturer exception.

[01:10:52] Speaker 01:
That's where they put fonts.

[01:10:54] Speaker 06:
Well, I don't think they should put the fonts there.

[01:10:57] Speaker 06:
I'm saying that's not the right way to interpret the statute.

[01:11:01] Speaker 01:
Well, that's the label they're putting them under for now.

[01:11:05] Speaker 01:
And so what we're struggling with here is you agree not identity, but we're trying to understand what the range is.

[01:11:14] Speaker 01:
And the reality of this record is, and you haven't challenged this, that the FDA decided when you did your study on putting your name, your brand name in Braille,

[01:11:30] Speaker 01:
you had to show them that it wasn't making, the label wasn't making administration of this drug less safe, unsafe, not safer.

[01:11:42] Speaker 01:
And all they did was decide it's not making it less safe, right?

[01:11:48] Speaker 01:
And so it was a choice, a design choice you were allowed to make because it didn't render it less safe.

[01:11:58] Speaker 06:
I think FDA recognized that following the recommendations, what Europe has done.

[01:12:02] Speaker 01:
They have a lot more Braille.

[01:12:05] Speaker 01:
Do you have the same with this label pass muster without additional Braille in Europe?

[01:12:10] Speaker 06:
Perhaps not.

[01:12:10] Speaker 06:
But again, so don't be giving me the only one who are doing it, Your Honor.

[01:12:14] Speaker 06:
We're the only ones moving towards Braille.

[01:12:17] Speaker 01:
OK.

[01:12:17] Speaker 01:
I mean, you said your piece on that.

[01:12:21] Speaker 01:
All right.

[01:12:21] Speaker 01:
The point here is.

[01:12:23] Speaker 01:
You chose to put your brand name in a particular font style, would call it font style Braille.

[01:12:31] Speaker 01:
A particular way of packaging your brand name and the 20 MG points.

[01:12:38] Speaker 01:
Neither of which all FDA decided, well, that won't make it less safe.

[01:12:43] Speaker 01:
You're allowed to do it.

[01:12:44] Speaker 01:
That's a stylistic choice you get to make.

[01:12:46] Speaker 01:
That's what FDA decided.

[01:12:48] Speaker 01:
You have not, unless I've misunderstood your brief seriously here, you have not challenged their decision

[01:12:57] Speaker 01:
They were wrong that this is, that having the brand name is, but not the active ingredient, is actually necessary for safety.

[01:13:06] Speaker 06:
Well, Your Honor, setting aside the arbitration.

[01:13:09] Speaker 06:
Well, no, Your Honor, because when this was put to the question of the director and the deputy director of then DPP, now the Department of Psychiatry, there was questions.

[01:13:19] Speaker 06:
They said, this may make it less safe for patients who won't have Braille.

[01:13:23] Speaker 06:
I'm not saying that's conclusively.

[01:13:25] Speaker 06:
I appreciate FDA is going to say there are differing views about the agency.

[01:13:29] Speaker 06:
But what it goes to is this bears on safety.

[01:13:31] Speaker 06:
This is not some irrelevant consideration that is completely tangential to safety.

[01:13:36] Speaker 06:
FDA recognizes it.

[01:13:38] Speaker 06:
They realize that putting it on is only helpful and useful.

[01:13:41] Speaker 01:
I don't know what you mean by relevant to safety.

[01:13:45] Speaker 01:
FDA didn't say, did they say it makes it more safe?

[01:13:50] Speaker 01:
They looked at our... They say it makes it more safe.

[01:13:53] Speaker 06:
They looked at our study results and found our study results showed that more people who are blind would be able to identify the product than who wouldn't be able to identify the product.

[01:14:01] Speaker 06:
I think that is a conclusion that it is more safe.

[01:14:04] Speaker 06:
They did not use the words, it's more safe.

[01:14:06] Speaker 02:
Marketing conclusion.

[01:14:09] Speaker 02:
Okay, it doesn't have anything to do with safety.

[01:14:12] Speaker 02:
That's why I said I thought that the citations you gave us weren't very helpful to your case.

[01:14:20] Speaker 06:
I think medication makes sense.

[01:14:22] Speaker 02:
You know, more people will use your product and that's good, all right?

[01:14:29] Speaker 02:
Because we want this product on the market, it will help people.

[01:14:33] Speaker 02:
But is it necessary for effective

[01:14:36] Speaker 06:
I mean, the US Access Board was created by Congress to provide recommendations for making medications more accessible to visually impaired and blind individuals.

[01:14:45] Speaker 02:
Well, accessible.

[01:14:46] Speaker 02:
I mean, your client is the good guy.

[01:14:49] Speaker 02:
All right?

[01:14:50] Speaker 02:
It's helping blind people.

[01:14:53] Speaker 02:
All right, not only with this new medication, but with the bottle so that blind people can find it easily.

[01:15:02] Speaker 02:
All right, that's sort of the argument, isn't it?

[01:15:06] Speaker 06:
Well, it's not just finding it, it's not mixing up their medications because if you have these in just the same pill bottle that has no distinguishing feature, it allows to medication mix-ups.

[01:15:15] Speaker 06:
This is a drug that is a specialty sleep medication that is designed to be taken an hour, half hour to an hour and a half

[01:15:22] Speaker 06:
before your targeted bedtime.

[01:15:24] Speaker 06:
And if you take that medication at the wrong time of day, it's going to make you go to sleep potentially.

[01:15:31] Speaker 01:
So information's not in Braille.

[01:15:33] Speaker 06:
It's telling you what this drug is.

[01:15:37] Speaker 06:
So this is that you know that you're taking this drug as opposed to a blood pressure medicine or some other medication you might be taking.

[01:15:43] Speaker 02:
All the Braille is telling us is that you manufacture your client.

[01:15:47] Speaker 06:
It's telling you what the drug is in the bottle.

[01:15:49] Speaker 06:
It's allowing you to identify this medication.

[01:15:53] Speaker 02:
It's like bear aspirin.

[01:15:56] Speaker 06:
Well, it's not it's not bad.

[01:15:57] Speaker 06:
It would be saying it's product is telling you this is it's not telling you.

[01:16:01] Speaker 06:
Panda is telling you this is this particular product.

[01:16:05] Speaker 06:
So, you know, this medication you're taking compared to, as I said, your blood pressure meds or some other kind of medication that may not have the same time sensitivity as the idea.

[01:16:15] Speaker 02:
And that's what you know, the record from FDA and your study shows it's a great idea.

[01:16:21] Speaker 04:
And didn't the FDA say to Vanda, it inquired whether Vanda considered if other important information such as the established name or usual dosage should also appear in Braille on the container label to promote the safe use of the product.

[01:16:39] Speaker 06:
Yes, I think there was a conversation and they decided back and forth with FDA.

[01:16:45] Speaker 06:
I think it was an agreement between Vanda and FDA for the first ever product that was going to put Braille that this was the Braille that was going to go on.

[01:16:55] Speaker 01:
You have not established that Braille is necessary for the safe and effective use of the drug product.

[01:17:03] Speaker 01:
FDA found.

[01:17:05] Speaker 06:
Where is that?

[01:17:05] Speaker 06:
Are you referencing this?

[01:17:06] Speaker 01:
924?

[01:17:07] Speaker 06:
This is the Citizens Petition.

[01:17:09] Speaker 06:
You're referencing the Citizens Petition response.

[01:17:11] Speaker 06:
Yes, this was not the underlying approval of our NDA.

[01:17:15] Speaker 06:
We're talking about the Citizens Petition rejection, is what I think you're underscoring from.

[01:17:19] Speaker 01:
Right, but you haven't shown that it is safe and effective, that it is necessary and safe and effective use of the drug product.

[01:17:25] Speaker 06:
Yes, that's our arbitrary and capricious claims after the fact ex post when we said it should be on.

[01:17:29] Speaker 06:
They rejected our arbitrary and capricious claims.

[01:17:31] Speaker 06:
That's different than when we went on with it and we explained that there were safety implications and they agreed that we could put it on our bottle.

[01:17:39] Speaker 01:
They say lots of things can be put on bottles.

[01:17:43] Speaker 01:
It doesn't mean that it's required.

[01:17:45] Speaker 01:
What I'm struggling with here is either the braille is necessary for safe and effective use, at which point, yes, it has to be on everyone's bottle, or having braille on there

[01:18:05] Speaker 01:
The drug itself is safe and effective and having Braille on there doesn't take that away.

[01:18:11] Speaker 06:
That's not what the statutory question asks.

[01:18:15] Speaker 01:
Which of those is the FDA decision?

[01:18:17] Speaker 01:
I think it's the latter.

[01:18:19] Speaker 01:
Reduce safety or effectiveness.

[01:18:22] Speaker 06:
And I'm saying they've gotten the statutory test wrong.

[01:18:24] Speaker 06:
That is not the test that is to be asked of does the label change reduce safety or efficacy.

[01:18:29] Speaker 01:
Oh, so no, wait, I'm sorry.

[01:18:32] Speaker 01:
I'm just doing this one step at a time.

[01:18:33] Speaker 01:
Sure.

[01:18:34] Speaker 01:
All right.

[01:18:34] Speaker 01:
So FDA found back when you guys wanted to put Braille on the label,

[01:18:44] Speaker 01:
Um, and they did the studies cause they had to know, you know, would it confuse people?

[01:18:49] Speaker 01:
Um, uh, you know, they have to be concerned about will, will is frail literacy so low that people might misinterpret the information.

[01:18:56] Speaker 01:
I'm sure they had to do all these things to make sure this isn't going to create a safety problem.

[01:19:01] Speaker 01:
That's what they care about.

[01:19:03] Speaker 01:
And you did your studies.

[01:19:04] Speaker 01:
They had a lot of criticisms of the studies, but they said at the end of the day, this isn't going to hurt.

[01:19:12] Speaker 01:
Is that correct?

[01:19:14] Speaker 06:
I don't think I agree with your characterization.

[01:19:16] Speaker 06:
They said it's not going to hurt, but they did allow it, and they allowed it after we- Say it's necessary for safety.

[01:19:22] Speaker 06:
I don't think they had an explicit finding it was necessary for safety.

[01:19:24] Speaker 01:
They have an implicit finding that was necessary.

[01:19:27] Speaker 06:
Well, that's my yes, because why else would you put it on the label?

[01:19:31] Speaker 04:
I mean, again, there's a difference between promoting safety and necessary for safety.

[01:19:36] Speaker 04:
But I understand your point to be that when you applied for approval, you raised a safety issue that would be addressed by Braille promoting safety, if not necessary.

[01:19:46] Speaker 04:
They went back and forth with you, seemed to agree that this was about safety because they said it themselves, and then they approved you.

[01:19:54] Speaker 04:
And then later, in a different decision, not relevant to the approval, but relative to the citizen suit, they said this wasn't necessary, but that was not the standard they applied when they approved you.

[01:20:08] Speaker 04:
And it is not the standard that's required by the statute.

[01:20:11] Speaker 06:
Yes, the standard by the statute is, is it the same label that was approved?

[01:20:15] Speaker 06:
And this goes to my hypothetical of maybe we didn't have to put or a drug didn't have to put a cardiovascular warning on the label and they did it out of excess caution because they were worried about litigation risk downstream.

[01:20:26] Speaker 06:
And maybe the FDA would have approved it anyway.

[01:20:28] Speaker 06:
But once that's the label, that's the label and it has to go forward, even if FDA says we might not have required it.

[01:20:34] Speaker 06:
And so it doesn't become optional for the generic.

[01:20:37] Speaker 06:
The things that can change from the label are when there is

[01:20:40] Speaker 06:
something about the product that differs from the branded product that requires a change.

[01:20:46] Speaker 06:
It requires a change.

[01:20:47] Speaker 06:
So a different manufacturer, of course, a different address, a different inactive ingredient.

[01:20:52] Speaker 01:
A solid de minimis and font styles.

[01:20:57] Speaker 06:
To be clear, in our view, that is not coming in through the different manufacturer exception.

[01:21:02] Speaker 06:
It's not a change required.

[01:21:03] Speaker 01:
But those things are all allowed by generics.

[01:21:05] Speaker 06:
They're allowed because it's not a difference.

[01:21:07] Speaker 06:
It's not violating the principal rule again.

[01:21:09] Speaker 06:
It's important to situate.

[01:21:11] Speaker 06:
We have a principal rule that says it's got to be the same and that we ask what does the same mean?

[01:21:17] Speaker 06:
Is it mean a carbon copy?

[01:21:18] Speaker 06:
And I've said, and we've been through, it's not a carbon copy.

[01:21:20] Speaker 06:
So there are differences, minute differences, that would not make something legally not the same.

[01:21:26] Speaker 06:
This is not a question this court has to address what that means, because FDA agrees that these labels are different and did not suggest that these are the same for legal purposes.

[01:21:36] Speaker 06:
Maybe they could have made that argument, but they didn't.

[01:21:39] Speaker 06:
And that, I don't think, would be a well-taken argument.

[01:21:41] Speaker 01:
Does that matter what slope or bright?

[01:21:44] Speaker 01:
I mean, we have to decide whether these things were

[01:21:50] Speaker 01:
Contrary to law, contrary to statute, does the statute allow this difference?

[01:21:57] Speaker 01:
Don't we have to decide both?

[01:22:01] Speaker 01:
both than any other avenues for whether this is allowed or not, whether it's sameness or different manufacturer, whether they wrap it all up together.

[01:22:09] Speaker 01:
Don't we have to decide that?

[01:22:10] Speaker 01:
At the end of it, they just have to decide whether this is same in that as we understand Congress to be using same in this and a provision.

[01:22:22] Speaker 06:
I do think same, Your Honor, would have some factual determinations that would get wrapped up in it.

[01:22:27] Speaker 06:
If you're going to say that two different labels that aren't carbon copies qualifies legally the same, which I think we all agree can be done, there would be factual questions that go to that.

[01:22:36] Speaker 06:
If something is the sort of minor change.

[01:22:38] Speaker 02:
You don't touch your argument.

[01:22:41] Speaker 02:
If we're going to get into factual questions, it seems to me.

[01:22:46] Speaker 02:
What we want to present is I understood it.

[01:22:49] Speaker 02:
And I thought that was what Judge Euletta saw.

[01:22:52] Speaker 02:
Is this a plain question of law?

[01:22:54] Speaker 02:
You look at the words, here's what Congress meant.

[01:22:59] Speaker 02:
All right?

[01:22:59] Speaker 02:
The label has to be the same.

[01:23:03] Speaker 02:
Period.

[01:23:05] Speaker 02:
End of discussion.

[01:23:07] Speaker 02:
All right?

[01:23:08] Speaker 02:
Unless the changes are necessary or required.

[01:23:14] Speaker 02:
And that's where you stop, right?

[01:23:16] Speaker 06:
I mean, I agree with everything you said, but that's the statute, Your Honor.

[01:23:19] Speaker 06:
I'm not sure the question worked.

[01:23:23] Speaker 02:
And you not only say there's more than low but bright here, but we agree there's some other types of changes that can be made.

[01:23:32] Speaker 06:
No, Your Honor.

[01:23:33] Speaker 02:
Well, that's not my argument.

[01:23:34] Speaker 02:
De minimis, fond changes.

[01:23:37] Speaker 02:
Okay.

[01:23:37] Speaker 02:
But that's okay with those.

[01:23:39] Speaker 02:
All right.

[01:23:40] Speaker 02:
So then my question is you say,

[01:23:48] Speaker 02:
Teva has just gone too far.

[01:23:51] Speaker 06:
No, Your Honor, that's not our argument at all.

[01:23:53] Speaker 02:
Well, I'm trying to close it down.

[01:23:56] Speaker 02:
If Teva had put your label on its product, they can't do that.

[01:24:02] Speaker 02:
So you agree there have to be changes.

[01:24:05] Speaker 02:
Yes.

[01:24:05] Speaker 02:
And you agree the FDA is supposed to determine whether a label accurately conveys information, right?

[01:24:15] Speaker 03:
Yes.

[01:24:18] Speaker 02:
Okay, so now it's got the active ingredient in large letters, bold.

[01:24:29] Speaker 02:
And so under your analysis, loper bright.

[01:24:36] Speaker 02:
Is that okay?

[01:24:39] Speaker 06:
It's a change required because our original product says Hetlios Bold, they cannot do that.

[01:24:45] Speaker 06:
So they have to change to Tazimeltian Bold.

[01:24:48] Speaker 06:
That is exactly what the statute obligates them as a change required.

[01:24:51] Speaker 06:
Yes, Your Honor, that's okay.

[01:24:52] Speaker 02:
So you're okay with that change?

[01:24:54] Speaker 06:
That is a textbook change required by the statute.

[01:24:58] Speaker 02:
And so the fact that you also give out these bonds, all right?

[01:25:05] Speaker 02:
FDA approved that too.

[01:25:07] Speaker 06:
But that's not a label issue, Your Honor.

[01:25:08] Speaker 06:
That's not copying the label.

[01:25:10] Speaker 06:
That's not the same.

[01:25:10] Speaker 02:
You are going on the label.

[01:25:12] Speaker 06:
Your Honor, yes.

[01:25:14] Speaker 06:
In a fanciful example where FDA approves, you know, some lottery giveaway to people who buy the medication, which would be unlawful under a whole host of other laws.

[01:25:21] Speaker 02:
But if that were the... That's the hypothetical.

[01:25:23] Speaker 06:
That's the hypothetical.

[01:25:23] Speaker 06:
It would be incredibly illegal because it would be a kickback and anti-stark violation.

[01:25:27] Speaker 02:
That would be an illegal thing.

[01:25:28] Speaker 02:
They give a bunch of flowers.

[01:25:30] Speaker 06:
Well, again, a QR code that gives you a coupon for flowers.

[01:25:35] Speaker 06:
I can't imagine a world in which FDA, the label on the bottle is a really important thing.

[01:25:41] Speaker 06:
I think it is.

[01:25:44] Speaker 02:
And looking at yours, all I know is that you're a brand name.

[01:25:49] Speaker 02:
It doesn't tell me what the active ingredients is.

[01:25:51] Speaker 06:
That's a criticism of the industry as a whole.

[01:25:56] Speaker 06:
That has nothing to do with our case.

[01:25:57] Speaker 02:
I'm just trying to understand, what could Congress have meant where a word can have different meanings?

[01:26:06] Speaker 02:
And so normally the Supreme Court instructs us, use the ordinary dictionary meaning unless Congress indicates it means something else.

[01:26:16] Speaker 02:
So we know that saying doesn't always mean identical.

[01:26:20] Speaker 02:
And you agree.

[01:26:21] Speaker 02:
And so here, the change to which you're objecting, in my hypothetical, is a determination by the agency to which Congress delegated this responsibility to determine

[01:26:40] Speaker 02:
What is necessary for the safe and efficacious use of a drug?

[01:26:46] Speaker 06:
It's Congress, so FDA made that determination with the brand.

[01:26:50] Speaker 02:
FDA says, we've looked at these studies about Braille, and we were concerned, as Judge Millett has emphasized, you know, is this going to make, cause a problem?

[01:27:04] Speaker 02:
And they say, no, it's not gonna cause a problem.

[01:27:06] Speaker 02:
But they never said,

[01:27:09] Speaker 02:
Unlike your brief, that it's either a condition of approval or that it's necessary for the safe and effective.

[01:27:18] Speaker 06:
Your honor, if that were what the statutory text were, I agree with you, I would have a very different case.

[01:27:23] Speaker 06:
That's just simply not what the statute directs the inquiry the FDA is to undertake right now.

[01:27:28] Speaker 02:
What is the statute say?

[01:27:30] Speaker 06:
The statute says first, the first requirement, prohibition.

[01:27:34] Speaker 06:
It says the label must be the same.

[01:27:36] Speaker 06:
So the first question is.

[01:27:38] Speaker 02:
So what do we.

[01:27:39] Speaker 02:
The same means.

[01:27:41] Speaker 06:
Yes.

[01:27:41] Speaker 06:
So this is where I go.

[01:27:42] Speaker 02:
Who decides that?

[01:27:44] Speaker 02:
You decide it, right?

[01:27:45] Speaker 02:
And even after Loper-Brite, the Supreme Court has said an Article 3 court can look at what the agency has said.

[01:27:56] Speaker 02:
The expert agency doesn't have to follow it necessarily.

[01:28:00] Speaker 02:
But it is going to be interested and presumably influenced by what the agency said.

[01:28:05] Speaker 06:
And the agency did not say this was the same.

[01:28:07] Speaker 06:
They said this is a different label.

[01:28:09] Speaker 06:
They said the opposite of that.

[01:28:10] Speaker 06:
They said it's, again, two-step process.

[01:28:13] Speaker 06:
One, is it the same?

[01:28:14] Speaker 06:
If not, is it justified by an exception?

[01:28:16] Speaker 02:
That's what you mean by the word same, if I may.

[01:28:19] Speaker 02:
That's all I'm trying to get, that there's one way to read that, understand that word,

[01:28:28] Speaker 02:
I say you have to wear the same suit tomorrow.

[01:28:32] Speaker 02:
We know exactly what that means, right?

[01:28:34] Speaker 02:
If I say we want you to wear the same suit by the same designer, I don't know what suit we're necessarily talking about.

[01:28:47] Speaker 02:
You could come in tomorrow with a gray suit.

[01:28:50] Speaker 02:
Is that the same?

[01:28:52] Speaker 02:
Or you could come in with a suit that has short sleeves.

[01:28:55] Speaker 02:
Is that the same?

[01:28:57] Speaker 06:
So this is, let me just point to the TEVA's summary judgment motion at 344.

[01:29:04] Speaker 06:
Let me quote from a TEVA's label, quote, the same as the label approved for the brand name drug, except that TEVA's label does not, end of the quote, use Braille.

[01:29:14] Speaker 06:
So they agree that their label is not the same in respect to the Braille.

[01:29:18] Speaker 06:
So it is established, I can point to Jay, 344.

[01:29:21] Speaker 01:
I think you all can recognize that.

[01:29:24] Speaker 01:
I don't think you need to prove that they omitted Braille and you have it.

[01:29:27] Speaker 06:
Well, what I'm saying, what they admit in the lower courts below, what FDA agrees is that the first step of the statute, if we didn't have an exception, if this had to be the same label, would the label be the same?

[01:29:41] Speaker 06:
The answer to that question is no.

[01:29:43] Speaker 06:
And no party has challenged it.

[01:29:45] Speaker 06:
And that's not.

[01:29:46] Speaker 04:
I think Judge Pan has had a question.

[01:29:47] Speaker 04:
If I may.

[01:29:49] Speaker 04:
On the Loper-Brite issue, why isn't it the case?

[01:29:53] Speaker 04:
I think it's true that Chenery survives Loper-Brite

[01:29:57] Speaker 04:
and principles of issue preservation survived Loper-Brite.

[01:30:01] Speaker 04:
In this case, before the agency, the focus was on interpreting whether the label was subject to this exception for changes required because the drugs are distributed by different manufacturers.

[01:30:20] Speaker 04:
That's what would happen for the agency.

[01:30:22] Speaker 04:
they did not address a different statutory interpretation question, which is, when is a new drug the same?

[01:30:29] Speaker 04:
Or when is the labeling proposed the same as the labeling approved as before?

[01:30:34] Speaker 04:
That wasn't before the agency because the FDA conceded that these were not the same.

[01:30:40] Speaker 04:
And because it wasn't before the agency, numerous factual things that we would need to know to decide this issue was not before the agency.

[01:30:49] Speaker 04:
And the legal arguments also were not made before the agency.

[01:30:52] Speaker 04:
their factual things would include a finding about why these are not the same, if that were the case, and what made them not the same, and an explanation of what the same means, as Judge Rogers was saying.

[01:31:04] Speaker 04:
What does that mean in this context?

[01:31:06] Speaker 04:
None of that is in this record.

[01:31:08] Speaker 04:
And therefore,

[01:31:10] Speaker 04:
it should be precluded by Channery, issue preclusion, et cetera, because regardless of if we have the first say on interpreting the same, we don't have a record to determine the same in this case.

[01:31:23] Speaker 06:
Yes, Your Honor.

[01:31:24] Speaker 06:
I agree.

[01:31:25] Speaker 06:
The same is just not an issue in this case.

[01:31:27] Speaker 06:
And it can't be because of Channery.

[01:31:29] Speaker 06:
It would be a factual issue.

[01:31:30] Speaker 06:
It's not been argued.

[01:31:32] Speaker 06:
It's not part of the case.

[01:31:33] Speaker 06:
What is the sole issue that was decided by FDA and that comes before the court is the scope of the changes required by a different manufacturer.

[01:31:42] Speaker 06:
That scope can't be interpreted to negate the meaning of the word required.

[01:31:46] Speaker 02:
Did you make this argument?

[01:31:50] Speaker 06:
Sorry, Your Honor.

[01:31:51] Speaker 06:
I didn't hear you.

[01:31:51] Speaker 02:
The Channery argument.

[01:31:53] Speaker 06:
Well, did I make a chenri argument?

[01:31:55] Speaker 06:
Yes.

[01:31:56] Speaker 06:
The FDA didn't make a sameness argument, so no, Your Honor.

[01:31:58] Speaker 02:
The sameness argument was... I just want to be clear what's before us, okay?

[01:32:03] Speaker 02:
You didn't make that argument, all right?

[01:32:05] Speaker 02:
Well, because... You knew what FDA was going to argue.

[01:32:10] Speaker 06:
But they didn't argue sameness.

[01:32:11] Speaker 06:
They haven't argued sameness in this court.

[01:32:12] Speaker 02:
Just saying you knew what their argument was going to be in response to yours.

[01:32:16] Speaker 02:
They weren't going to say,

[01:32:17] Speaker 02:
Let's withdraw the appeal because even before this court, they don't make a statement.

[01:32:22] Speaker 01:
How about see what FDA has to say this?

[01:32:25] Speaker 01:
Can I ask you one quick?

[01:32:26] Speaker 01:
I apologize folks.

[01:32:27] Speaker 01:
Just one quick fact question.

[01:32:29] Speaker 01:
Just just a quick fact question.

[01:32:31] Speaker 01:
Nothing more.

[01:32:39] Speaker 01:
When FDA asks.

[01:32:42] Speaker 01:
Why?

[01:32:43] Speaker 01:
He's putting your proprietary name and strength and safety, blah, blah, blah.

[01:32:49] Speaker 01:
And Vanda's response is, Vanda proposes presenting the proprietary name and strength and braille on the label and providing patients an appropriate medication guide in braille, black and white, and audio formats.

[01:33:02] Speaker 01:
Yes.

[01:33:02] Speaker 01:
Do you do that?

[01:33:03] Speaker 06:
We do.

[01:33:03] Speaker 06:
We have a book.

[01:33:04] Speaker 06:
I have a copy of it in my office that has like a little... The audio and everything.

[01:33:07] Speaker 01:
Yeah.

[01:33:08] Speaker 01:
With every single bottle that goes out.

[01:33:09] Speaker 06:
Yeah.

[01:33:10] Speaker 06:
Well, it's a welcome package, a welcome kit that when a patient is enrolled with Helios, they get a welcome kit that has a brochure with Braille that has lots of Braille all around the brochure.

[01:33:20] Speaker 06:
It's several pages of Braille.

[01:33:21] Speaker 06:
And they also have an audio thing where they click a button and they can listen to all the audio.

[01:33:25] Speaker 01:
So I...

[01:33:26] Speaker 01:
My understanding is, sorry, that a lot of these things, is that part of the label?

[01:33:31] Speaker 06:
It's not part of the label.

[01:33:34] Speaker 06:
We've not argued and I don't believe it is not part of the label as such, but we do do it and I'll be happy to give court copies if the court would like to see it.

[01:33:43] Speaker 02:
So just so it's very quickly, so a generic doesn't have to include that.

[01:33:49] Speaker 06:
We've not taken the position as part of the label.

[01:33:52] Speaker 06:
I think FDA would agree it's not part of the label.

[01:33:54] Speaker 06:
It's something that we do to give.

[01:33:58] Speaker 01:
It's not an insert that comes with the medication, like those big inserts.

[01:34:02] Speaker 06:
To be clear about this, and I can confirm, I don't believe it comes with every single bottle of the product.

[01:34:07] Speaker 06:
What happens is when a patient enrolls, they get a welcome package that says, you get a package in the mail that says,

[01:34:14] Speaker 06:
from the pharmacy?

[01:34:15] Speaker 06:
Yes, it includes a big guide and braille and includes an audio guide where you can get all this information read to you.

[01:34:25] Speaker 01:
Okay, thank you.

[01:34:28] Speaker 01:
All right, one left, sorry.

[01:34:36] Speaker 01:
Okay, ten minutes to respond.

[01:34:46] Speaker 00:
Good morning, may it please the court, David Peters on behalf of the United States of America.

[01:34:49] Speaker 00:
Congress enacted the Hatch-Blaxman amendments to facilitate the introduction to the market of low-cost generic drugs that are as safe and effective as their brand-name counterparts.

[01:35:00] Speaker 00:
As part of that scheme, generic drugs must copy numerous labeling features of the brand-name drug,

[01:35:06] Speaker 00:
such as safety warnings or dosage information that are necessary to the drug's safe and effective use.

[01:35:12] Speaker 00:
But where a brand name manufacturer includes discretionary labeling information or makes formatting choices that while permissible are not necessary to the drug's safe and effective use, the generic manufacturer may elect to omit those features.

[01:35:27] Speaker 00:
That narrow exception to the same labeling requirement furthers the statutory scheme by ensuring that the same labeling requirement is not leveraged to deter generic management.

[01:35:36] Speaker 04:
What's the statutory basis for that?

[01:35:38] Speaker 04:
Like, I can understand why that is a sensible way to proceed.

[01:35:41] Speaker 04:
But where's the connection to the actual statute?

[01:35:45] Speaker 00:
I think it's a different manufacturer exception.

[01:35:47] Speaker 00:
I mean, the FDA has long understood that exception to permit certain labeling changes and certain other changes to drugs that generic manufacturers are allowed to make by virtue of the statute.

[01:36:00] Speaker 00:
And I don't actually understand Vanda to be really disagreeing with that argument.

[01:36:03] Speaker 00:
I mean, Vanda kind of has this, you know, it relies on this textualist argument.

[01:36:07] Speaker 00:
But when you hear the kind of formulation of their textualist account, it's, you know, changes that are external to the drug itself.

[01:36:13] Speaker 04:
That's not the statute required, though.

[01:36:15] Speaker 04:
Like, I don't see how your interpretation fits with required because the change has to be required because the new drug and listed drug are produced or distributed by different manufacturers.

[01:36:27] Speaker 00:
I mean, yes, your honor.

[01:36:28] Speaker 00:
FDA has long understood that provision to allow certain changes that are permissible for generic manufacturers to make.

[01:36:34] Speaker 00:
And so I think an example that might be helpful.

[01:36:36] Speaker 02:
That's not what I'm saying, Your Honor.

[01:36:38] Speaker 02:
Sorry, go ahead.

[01:36:39] Speaker 02:
No, no, please, go ahead.

[01:36:40] Speaker 00:
No, Your Honor, I'm not saying required is permissible.

[01:36:42] Speaker 00:
What I'm saying is required, I think, in this statutory text is meant to mean appropriate or suitable in a given context.

[01:36:48] Speaker 00:
And the reason that that provision has to have that meaning is because everyone agrees.

[01:36:53] Speaker 00:
Look at page one of the reply brief.

[01:36:55] Speaker 00:
everyone agrees that generic manufacturers can make changes to their drugs or to the labels that are permissible, right?

[01:37:03] Speaker 00:
So the easiest example, I think the easiest example is that for formulations, right?

[01:37:10] Speaker 00:
The Zeneca case is a good example, but generic manufacturers can formulate their drugs with inactive ingredients that are different than the inactive ingredients that brand name drugs formulate a drug with.

[01:37:21] Speaker 01:
We have to disclose that because, I mean, that has to be on the label for safety reasons.

[01:37:26] Speaker 01:
People have to know what inactive ingredients are because they could have an allergy to it.

[01:37:30] Speaker 01:
Certainly, Your Honor, but the point I think is- That's required because they're manufacturing differently than the name brand.

[01:37:35] Speaker 00:
But it's required because they're making it change their product.

[01:37:37] Speaker 00:
It's not required because there's a different manufacturer.

[01:37:39] Speaker 00:
The generic manufacturer could always formulate their product with the same inactive ingredient.

[01:37:44] Speaker 00:
I mean, that's why I think you have to understand that statutory text to be, you know, we agree that it is a bit opaque.

[01:37:53] Speaker 01:
But we think that they couldn't do it economically, that it's cheaper.

[01:37:56] Speaker 01:
It makes it cheaper as a generic to use X inactive ingredient rather than Y. It's just an inactive ingredient.

[01:38:04] Speaker 00:
And that's a permissible choice that a generic manufacturer can make.

[01:38:07] Speaker 00:
But if you take required to mean strictly obligatory, there's no way it's strictly obligatory for a generic manufacturer to formulate its product in the exact same way or for another example.

[01:38:17] Speaker 00:
FDA has long understood this.

[01:38:19] Speaker 04:
Why isn't that required?

[01:38:20] Speaker 04:
Because it's a different manufacturer that's using different stuff.

[01:38:23] Speaker 04:
So it's required to make the label accurate.

[01:38:27] Speaker 00:
Sorry.

[01:38:28] Speaker 00:
I agree that the different manufacturer is broad enough to encompass that situation because there is a new manufacturer.

[01:38:33] Speaker 00:
The manufacturer has made a choice that it's permitted to make by virtue of the statute.

[01:38:37] Speaker 00:
And then by virtue of that choice, I think it's fair to say that it's then suitable to make the changes to the labeling.

[01:38:44] Speaker 00:
That's exactly the same here, right?

[01:38:46] Speaker 00:
The labeling features that are at issue here are labeling features that FDA determined were not necessary to the safe and effective use of the drug.

[01:38:54] Speaker 04:
And when- That's in the manufacturing.

[01:38:57] Speaker 04:
It's required because it's a different manufacturer.

[01:38:59] Speaker 04:
The manufacturer has used a different ingredient.

[01:39:02] Speaker 04:
But the labeling with Braille doesn't fall within that.

[01:39:05] Speaker 00:
I mean, those labeling features are not required because it's a new manufacturer.

[01:39:09] Speaker 00:
The new manufacturer could, if you take required to mean strictly obligatory.

[01:39:14] Speaker 04:
The manufacturer has manufactured a generic drug and it has certain features and the label needs to be.

[01:39:20] Speaker 04:
Accurate certainly.

[01:39:22] Speaker 04:
So it's required because the manufacturing process is different here and we're going to explain that we're not going to have like an inaccurate label.

[01:39:30] Speaker 00:
It is appropriate because it's a new manufacturer.

[01:39:32] Speaker 00:
Our view is that it's appropriate here to make labeling changes because there's a new manufacturer.

[01:39:36] Speaker 04:
That doesn't mean the manufacturer can do anything they want on a whim.

[01:39:39] Speaker 00:
Absolutely not, Your Honor.

[01:39:40] Speaker 00:
That's not our position.

[01:39:41] Speaker 00:
Our position is that

[01:39:42] Speaker 00:
As has been discussed for some time prior to becoming the podium, there is extensive regulations of the information that generic manufacturers have to have on their label that are required for the generic, sorry, for the brand name drug to be safe and effective.

[01:39:58] Speaker 02:
What about what Congress required?

[01:40:00] Speaker 02:
Same label as approved by FDA.

[01:40:05] Speaker 00:
Sure.

[01:40:05] Speaker 00:
And everyone agrees that same, everyone agrees that labels don't have to be identical.

[01:40:10] Speaker 00:
My colleague on their side is now trying to kind of make these say, well, there's de minimis harm, but actually maybe whether something is de minimis is fact dependent.

[01:40:18] Speaker 00:
Who knows?

[01:40:18] Speaker 00:
I mean, I think the more straightforward way to read the statue is same means same.

[01:40:22] Speaker 00:
They have to be the same.

[01:40:23] Speaker 00:
But the different manufacturer exception allows generic manufacturers to make changes.

[01:40:28] Speaker 00:
And so just to go back... That are required.

[01:40:29] Speaker 04:
So how do you map that on with your position?

[01:40:31] Speaker 04:
What's your best argument that this change was required because it was a different manufacturer?

[01:40:38] Speaker 00:
I will.

[01:40:38] Speaker 00:
So Your Honor, there are certain, there are extensive regulations of the information that must be included on a brand name label when that brand name label is approved.

[01:40:51] Speaker 00:
Braille is not one of them, right?

[01:40:53] Speaker 04:
And Braille is one of many design choices that manufacturing- You're making an argument, but I'm asking you to tie this to the text.

[01:41:00] Speaker 00:
Give me your best argument as to why what happened in this case was required because the new drug was produced or distributed by- And if I may, Your Honor, there is any number of discretionary labeling choices that a brand name manufacturer may make about its product.

[01:41:19] Speaker 00:
What the statutory scheme allows is for a generic manufacturer to change those kind of non-required elements of a label.

[01:41:27] Speaker 00:
And so when there is a new manufacturer, they are able to make- They're getting that.

[01:41:31] Speaker 04:
They can change non-required elements of a label.

[01:41:33] Speaker 04:
Where'd you get that?

[01:41:34] Speaker 00:
It flows from the fact that the way the statutory scheme works is that there is certain information that has to be included on a brand name's label, but there is information that the generic- But the statute says the generic has to be the same except things that are required because the new drug and listed drug are produced.

[01:41:52] Speaker 04:
And I'm not getting an answer from you as to why this particular change was required because they're different manufacturers.

[01:41:59] Speaker 00:
I think that the word required does not mean strictly obligatory.

[01:42:02] Speaker 00:
It means, is this a type of change that is suitable under the circumstances of the statutory scheme?

[01:42:07] Speaker 04:
Okay, so stop.

[01:42:09] Speaker 04:
What's your best argument for why this is suitable under the statutory scheme?

[01:42:14] Speaker 00:
Yes, that for a brand name manufacturer, when it submits its label.

[01:42:17] Speaker 04:
It's a whim.

[01:42:18] Speaker 04:
This is why they did it.

[01:42:19] Speaker 04:
They just didn't want to do it.

[01:42:20] Speaker 04:
So any whim is suitable?

[01:42:22] Speaker 00:
No, Your Honor.

[01:42:23] Speaker 00:
The key determination here was that FDA determined that the inclusion of this limited amount of information in Braille was not necessary to the drug's safe and effective use.

[01:42:32] Speaker 04:
So I understand that that's what FDA determined.

[01:42:33] Speaker 04:
But I think the question is whether that complied with the statute.

[01:42:36] Speaker 04:
And basically, I can see why that would be a logical way to proceed.

[01:42:40] Speaker 04:
I just don't see how it's connected to the statute.

[01:42:43] Speaker 04:
And I will say, I was surprised to see the communications going on with an FDA where nobody's talking about the statute.

[01:42:50] Speaker 04:
Everybody's just kind of opining, is this safe?

[01:42:53] Speaker 04:
I don't know if it's safe.

[01:42:53] Speaker 04:
I don't think it matters.

[01:42:55] Speaker 04:
Other drugs don't have that.

[01:42:56] Speaker 04:
But nobody asked the general counsel of the FDA, does that not happen at the FDA?

[01:43:02] Speaker 04:
To ask if there are legal requirements as opposed to just what we think?

[01:43:06] Speaker 00:
No, I mean, the FDA understands that the generic, this is what I was trying to say, the FDA has long understood the generic manufacturer, sorry, the different manufacturer exception to allow generic manufacturers to make changes, including to labeling features that are not necessary to the drug's approval.

[01:43:25] Speaker 02:
Appel that interpretation.

[01:43:27] Speaker 02:
You know, there's very few cases, but I think it's exactly so judge hands questions.

[01:43:33] Speaker 02:
Right on point and you've got to answer them, whether you like it or not, because obviously the panel is very concerned about that and saying that FDA is already always done this or it's a reasonable interpretation.

[01:43:47] Speaker 02:
that's not good enough.

[01:43:49] Speaker 00:
I mean even the hypotheticals that were given today right something if the generic and the brand name manufacturer elects to include on its label something that says vegan or halal or kosher or gluten-free those are all

[01:44:03] Speaker 00:
voluntary choices about the labeling features that the brand name manufacturer has taken.

[01:44:08] Speaker 00:
And the generic is not required to copy those kind of almost design features of the brand name drugs labeling.

[01:44:19] Speaker 01:
That might go to whether it violates the sameness requirement at all.

[01:44:24] Speaker 01:
What does same mean under the statute?

[01:44:27] Speaker 01:
Does same mean

[01:44:29] Speaker 01:
all the things, the extensive things that are required for safety and efficacy.

[01:44:33] Speaker 01:
So you have to have the same safety and efficacy label as them, but that's not, that still doesn't mean it's required.

[01:44:40] Speaker 01:
I mean, what is your, to build on here, what is your best case for required means appropriate?

[01:44:49] Speaker 01:
I would thought Congress would have said.

[01:44:51] Speaker 00:
I would point to Zeneca, your honor.

[01:44:52] Speaker 00:
I mean, look to Zeneca.

[01:44:53] Speaker 00:
Zeneca was a, Zeneca was a,

[01:44:58] Speaker 00:
It is, the sectionary language is required because there is a new manufacturer.

[01:45:02] Speaker 00:
And if you take Vanna's argument literally, and it means that it's strictly obligatory because there's a new manufacturer, there's no way Zeneca comes out the way it does.

[01:45:13] Speaker 00:
I mean, Zeneca was an elective choice that the generic manufacturer made about formulation of its drug.

[01:45:18] Speaker 00:
I mean, it could always have just formulated its drug using the same inactive ingredients.

[01:45:23] Speaker 00:
And your honor.

[01:45:24] Speaker 04:
I guess, I feel like those cases are a little bit different because

[01:45:28] Speaker 04:
If a generic uses a different ingredient, the label has to be accurate.

[01:45:33] Speaker 04:
So it is required, because this different manufacturer has manufactured the drug in a different way, to put that on the label.

[01:45:40] Speaker 04:
But what I'm not understanding from your argument is what required really means here.

[01:45:45] Speaker 04:
Because required could mean obligatory or could mean suitable appropriate.

[01:45:49] Speaker 04:
But you are giving even suitable appropriate such a broad meaning that just because a generic manufacturer doesn't feel like putting it on, that's suitable and appropriate.

[01:45:58] Speaker 00:
I don't think that's right.

[01:45:59] Speaker 00:
I mean, there was an extensive discussion today about fonts and formatting and highlighting and all of those things related to same, but now we're, we're where I think that's the wrong required.

[01:46:09] Speaker 00:
I think that's the wrong way to read the statute.

[01:46:10] Speaker 00:
I mean, we think the same means same.

[01:46:12] Speaker 00:
It has to be the same, except unless there's a different, it falls into different manufacturer exception.

[01:46:17] Speaker 04:
But in this case, you conceded that these are different.

[01:46:20] Speaker 04:
So now the question is, I'm just trying to drill down on what's before us, which is we're interpreting except for changes required because the new drug and listed drug are produced or distributed by different manufacturers.

[01:46:31] Speaker 04:
You say required doesn't mean obligatory, even though that's the more natural reading.

[01:46:34] Speaker 04:
But even given that, you say it could mean appropriate.

[01:46:38] Speaker 04:
So why is it appropriate?

[01:46:40] Speaker 04:
Why is it appropriate here?

[01:46:41] Speaker 00:
But it's appropriate because it serves a statutory scheme.

[01:46:45] Speaker 00:
I mean, the whole point of the statutory scheme is to make sure that generic drugs are as safe and effective as their brand name counterparts, and they are able to enter the market.

[01:46:54] Speaker 04:
And the concern here... But that doesn't mean it's affirmatively appropriate.

[01:46:57] Speaker 04:
That just means it's not unsafe.

[01:46:58] Speaker 00:
No, it means appropriate.

[01:46:59] Speaker 00:
Why isn't a good thing?

[01:47:00] Speaker 00:
Because the statutory scheme gives generic manufacturers some amount of leeway about how they craft their label.

[01:47:06] Speaker 00:
Our point about the font and the and all that is I don't think it's right to say, well, that's all fine because we understand same to allow any number of these exceptions.

[01:47:17] Speaker 00:
Our view is that same means same.

[01:47:20] Speaker 00:
And the reason that you can make changes to font or highlighting or any number of those other things is because they fall within the different manufacturer exception, which is why when you have a question.

[01:47:29] Speaker 04:
Now I'm confused.

[01:47:30] Speaker 04:
How do you think same falls into them?

[01:47:33] Speaker 04:
So there are two parts of this, right?

[01:47:35] Speaker 04:
One part, it has to be the same, and the second is there's perception.

[01:47:38] Speaker 04:
So how are you putting those together?

[01:47:40] Speaker 04:
Because you just incorporated the same into the second part.

[01:47:44] Speaker 00:
No, my friend on the other side says it's totally fine.

[01:47:47] Speaker 00:
Because my friend on the other side says problems of the text as well.

[01:47:49] Speaker 00:
But their view is...

[01:47:51] Speaker 00:
Of course, a drug that has, like this one, that has a different formatting, layout, font, fileting, any number of those other features, everyone agrees that's totally fine.

[01:48:01] Speaker 00:
And so their view is that that's fine because same doesn't encompass that.

[01:48:06] Speaker 00:
And my point is, no, same encompasses things like font, like formatting, but to the extent that the generic manufacturer can change that, it is because that's permissible under the different manufacturer exception.

[01:48:22] Speaker 00:
Otherwise, you have the exact same.

[01:48:24] Speaker 04:
Even get to the permissible manufacturer exception if they're the same.

[01:48:28] Speaker 04:
If they're not, I'm sorry.

[01:48:30] Speaker 04:
You have to do the same misperse before you get to the manufacturing.

[01:48:36] Speaker 00:
The reason we didn't make the same misargument is because we agree these labels are different.

[01:48:39] Speaker 00:
We would agree that two labels that had different fonts would be different.

[01:48:42] Speaker 00:
We agree that labels that have different highlighting.

[01:48:44] Speaker 01:
Same doesn't mean identical either.

[01:48:46] Speaker 01:
I mean, the same dictionaries they're using say essentially same means alike in material content.

[01:48:53] Speaker 00:
But the same problem that you identified, Judge Muller, when you said, well, what about font for something on Android that primarily treats individuals who are dyslexic?

[01:49:03] Speaker 00:
That actually might have real problems and real safety and efficacy problems.

[01:49:07] Speaker 00:
I think the best way to think about that is not to make some kind of analysis as to whether it's safe or not, is to say, is that a permissible choice that a different manufacturer can make because it doesn't affect the safety and efficacy of the drug?

[01:49:23] Speaker 01:
The statute does not say that the exception is not changes that are permissible for a different manufacturer to make, that are appropriate for a different manufacturer to make, that are required because it's a different manufacturer.

[01:49:40] Speaker 00:
Well, you're right.

[01:49:43] Speaker 00:
I think that the best way to understand the word required is because it's appropriate given the circumstances in light of this statutory scheme.

[01:49:49] Speaker 02:
And we think that these types of- What we're trying to get at is the statutory language, the plain text.

[01:49:55] Speaker 02:
And let me just throw in one other aspect.

[01:49:58] Speaker 02:
I know we don't look at legislative history anymore, but the whole point of Hatch-Waxman was to get these generic drugs on the market quickly.

[01:50:09] Speaker 02:
They could piggyback on all the research that was done, which FDA had approved for the pioneer drug.

[01:50:20] Speaker 02:
So Congress says, let's get these generics out there fast.

[01:50:26] Speaker 02:
Use the same label.

[01:50:29] Speaker 02:
You're going to have to change the manufacturer's name if there's a different manufacturer.

[01:50:36] Speaker 02:
other required change.

[01:50:39] Speaker 02:
In other words, Congress said, get these generics out.

[01:50:43] Speaker 02:
We don't want you coming back to the FDA, then to the district court, then to the Court of Appeals, then to the Supreme Court.

[01:50:49] Speaker 02:
And 12 years down the road, this generic is finally

[01:50:54] Speaker 02:
out there because we know what same means as to the same label that's been approved.

[01:51:03] Speaker 02:
So if FDA went ahead and approved a label that has Braille in it, that's what the generic has to do.

[01:51:13] Speaker 02:
And we don't have to have all this litigation about it.

[01:51:16] Speaker 00:
No, Your Honor.

[01:51:17] Speaker 02:
Congress said, you know, unless there's some other problem, like

[01:51:24] Speaker 02:
a legal problem, it didn't say, in all those exceptions, and such other conclusion as the FDA may decide is reasonable and appropriate.

[01:51:42] Speaker 02:
Now, I mean, you've got to deal with that scheme for me and answering the question.

[01:51:47] Speaker 00:
I understand.

[01:51:48] Speaker 02:
And either you think

[01:51:50] Speaker 02:
These are not required or no, not you, but FDA thinks these are not required.

[01:51:59] Speaker 02:
I think Judge Pan has been trying to get this answer.

[01:52:03] Speaker 02:
We need help.

[01:52:04] Speaker 00:
I understand.

[01:52:04] Speaker 00:
The statutory scheme was intended to ensure that generic manufacturers can enter the market as fast and effectively.

[01:52:10] Speaker 00:
And what the concern here and the reason why the different manufacturer exception has been understood the way it has been understood is because there is a serious concern with a generic manufacturer electing to include all number of things on the label that are entirely unnecessary to the drug safe and effective use.

[01:52:27] Speaker 02:
It said the same label as approved by the FDA.

[01:52:33] Speaker 02:
And if the FDA approved a label that has, what did you say?

[01:52:41] Speaker 02:
Flowers going out with each dosage.

[01:52:45] Speaker 02:
each 20 milligrams, so be it.

[01:52:47] Speaker 02:
That's what the generic is stuck with it.

[01:52:50] Speaker 00:
No, Your Honor.

[01:52:51] Speaker 00:
I mean, I don't think that's right.

[01:52:52] Speaker 02:
Because otherwise, you're spending 12 years in litigation.

[01:52:56] Speaker 02:
And the public never gets the generic.

[01:52:59] Speaker 00:
I mean, just think about that example, Your Honor.

[01:53:01] Speaker 00:
If the end result of this case is that a generic, a brand name manufacturer can put anything it wants on its label and increase the cost that generic manufacturers won't be able to enter the market, that undermines the very purpose of the statutory scheme.

[01:53:13] Speaker 02:
Ah, but FDA can deal with that in dealing with the pioneer drug because FDA can say, well, this might be very nice, but it's not necessary.

[01:53:25] Speaker 02:
No, you're effective.

[01:53:28] Speaker 00:
That misunderstands the FDA's role in approving the brand name drugs label.

[01:53:32] Speaker 02:
That's my point.

[01:53:34] Speaker 02:
That's what Congress said.

[01:53:36] Speaker 02:
FDA has a limited role.

[01:53:38] Speaker 02:
It's already done everything that requires expertise, namely all these studies that it's approved for the pioneer.

[01:53:48] Speaker 00:
Yeah, I don't think that's right.

[01:53:49] Speaker 02:
I mean, okay.

[01:53:51] Speaker 00:
The brand name drug has substantial discretion over what it includes on its brand name label.

[01:53:57] Speaker 00:
And it may include information that even FDA determines is not necessary to the safe and effective use of the drug.

[01:54:03] Speaker 00:
That includes Braille.

[01:54:04] Speaker 00:
FDA did not determine that Braille was necessary to the drug's safe and effective use.

[01:54:08] Speaker 02:
Why would Congress want all this debate about what a same label means?

[01:54:13] Speaker 02:
When it's clear, you're not going to put out misinformation.

[01:54:17] Speaker 02:
So if there's a different name and you're just putting out the active ingredient, and if there's anything else that Judge Millett and Judge Pan's questions have been focusing on,

[01:54:30] Speaker 02:
then those changes have to be made.

[01:54:32] Speaker 03:
I agree.

[01:54:33] Speaker 02:
We're not going back to have more studies about Braille.

[01:54:36] Speaker 02:
We've had studies about Braille and FDA has approved the label with Braille.

[01:54:43] Speaker 02:
So why not just go forward with that?

[01:54:45] Speaker 02:
And if no generic can get on the market, well, that's another issue.

[01:54:50] Speaker 02:
They can come back to FDA and we can start all over again or go back to Congress and get the statute amended.

[01:54:56] Speaker 00:
I don't think that's right.

[01:54:58] Speaker 00:
The point of the generic drug statute is to ensure that generic drugs can enter the market to ensure that they are as safe, as effective as their brand name counterparts.

[01:55:07] Speaker 00:
If there is brand name labeling that is not at all necessary to the safe and effective use of the drug, which is what FDA determined was the case with the Braille, then it makes good sense to think that when the brand name manufacturer elects to make design choices that are entirely elective, but then that gets approved.

[01:55:23] Speaker 00:
If a generic manufacturer comes along and there's a different manufacturer and that different manufacturer makes

[01:55:27] Speaker 00:
different design choices, those design choices.

[01:55:30] Speaker 02:
Perfect sense.

[01:55:30] Speaker 02:
Let me just make one point.

[01:55:33] Speaker 02:
I'm not suggesting that's not true, okay?

[01:55:38] Speaker 02:
But that's not the statute Congress wrote.

[01:55:42] Speaker 02:
It said same label as approved by FDA.

[01:55:49] Speaker 00:
I think the different manufacturer exception has to be given practical understanding.

[01:55:52] Speaker 00:
And the practical understanding of different manufacturer exception means that when the statutory scheme.

[01:55:57] Speaker 01:
Practicality.

[01:56:02] Speaker 01:
Any practicality has to fit within the words Congress used.

[01:56:07] Speaker 01:
And I think Judge Pan has asked, and I've asked, and Judge Rogers has asked, if you have any authority at all

[01:56:19] Speaker 01:
that says required because, it's a new manufacturer, required because means safe because, appropriate because, effective because.

[01:56:34] Speaker 00:
That last clause makes a difference, right?

[01:56:39] Speaker 00:
If you take

[01:56:40] Speaker 00:
The last clause says, because there's a new manufacturer.

[01:56:43] Speaker 00:
The reason why I think Zeneca is illustrative, right?

[01:56:46] Speaker 01:
Or cases like... That was another ingredient case.

[01:56:50] Speaker 01:
I get you say they could choose how they manufacture, but it is at least a fair reading to say a manufacturer manufactures the drug differently and has to disclose that that falls within the different manufacturer, right?

[01:57:06] Speaker 01:
It's not that we require the manufacturer to do it, but we're required because this manufacturer manufactures the drug differently.

[01:57:14] Speaker 01:
That would might be a permissible reading.

[01:57:16] Speaker 01:
We'd have to decide if that's a better reading, but that might be a permissible reading of the statute.

[01:57:21] Speaker 01:
But you want to do with what you want to shove into this exception.

[01:57:24] Speaker 01:
How is this manufacturer?

[01:57:29] Speaker 01:
likes a different font.

[01:57:31] Speaker 00:
I don't think that's right.

[01:57:32] Speaker 00:
No, sorry.

[01:57:34] Speaker 00:
I was much too quick and I should have, my apologies.

[01:57:37] Speaker 00:
Yes.

[01:57:38] Speaker 00:
If a different manufacturer says, you know, I'm going to make a different discretionary design choice about the label, which is essentially what this

[01:57:47] Speaker 00:
this braille is, that is a permissible change on the different manufacturer, etc.

[01:57:53] Speaker 01:
We think that the different... Okay, I'm really struggling.

[01:57:57] Speaker 01:
If you wanted to say that's a permissible change under the statute, that could make sense depending on how one reads sameness, a material sameness.

[01:58:09] Speaker 01:
Or sameness as in meets all the statutory thousands of statutory requirements required for labels, but that's not your argument.

[01:58:17] Speaker 01:
Your argument is that I prefer this font.

[01:58:23] Speaker 01:
Because.

[01:58:25] Speaker 01:
What does that have anything to do with being with the manufacturing process?

[01:58:31] Speaker 01:
No, no, it's different to do with the fact there's a different manufacturer.

[01:58:36] Speaker 01:
It's required there anything required about that as opposed to chosen.

[01:58:43] Speaker 00:
Yeah, I mean.

[01:58:44] Speaker 01:
I don't understand.

[01:58:45] Speaker 01:
Do you have any case that required the way you are?

[01:58:48] Speaker 00:
I think the Hill case that we set in our brief is also on point.

[01:58:54] Speaker 00:
I mean, that's another example in which the brand name manufacturer elected to include a certain peanut protein testing mechanism, right?

[01:59:03] Speaker 00:
And that labeling was approved.

[01:59:06] Speaker 01:
That's part of the manufacturing process?

[01:59:09] Speaker 00:
Yes, Your Honor.

[01:59:09] Speaker 01:
OK, do you have anything that's not?

[01:59:11] Speaker 01:
What you're doing is giving me cases

[01:59:14] Speaker 01:
under this exception that have involved manufacturing processes that differ, which then need to be disclosed.

[01:59:21] Speaker 01:
What I'm asking you, you can go out of the FDA context, you can go anywhere you want and tell me a case.

[01:59:27] Speaker 01:
I mean, sometimes, yeah, we have cases that say shall means may and may can mean shall, but is there a required means?

[01:59:34] Speaker 00:
Suitable or appropriate?

[01:59:35] Speaker 00:
I think it's suitable or appropriate.

[01:59:37] Speaker 00:
I think that's a fair reading of the definition.

[01:59:39] Speaker 00:
That's the one that district court adopted.

[01:59:40] Speaker 01:
Sorry, sorry, I'm gonna ask again.

[01:59:44] Speaker 01:
Do you have any case that has read required to mean that other than the district court decision?

[01:59:50] Speaker 01:
It seems like the word required is the opposite of optional.

[01:59:57] Speaker 00:
Yeah, I mean.

[01:59:59] Speaker 00:
A few things.

[01:59:59] Speaker 00:
I will point to this court's decision in the railway case that we cited.

[02:00:02] Speaker 00:
That was another instance when the court said required does not mean strictly obligatory.

[02:00:08] Speaker 00:
It is often used required and necessary or often used in senses that are not strictly obligatory.

[02:00:12] Speaker 01:
Necessary.

[02:00:13] Speaker 01:
Okay.

[02:00:13] Speaker 01:
I'm good.

[02:00:15] Speaker 01:
Okay.

[02:00:15] Speaker 01:
So not strictly obligatory, but the meaning you want to give it here is optional.

[02:00:21] Speaker 00:
I don't want, the point is not optional, Your Honor.

[02:00:24] Speaker 00:
It is appropriate.

[02:00:24] Speaker 01:
It's a manufacturer can make.

[02:00:26] Speaker 00:
It is the choice the manufacturer can make consistent with the statute where safety and efficacy.

[02:00:30] Speaker 00:
Sounds like optional.

[02:00:31] Speaker 01:
Optional consistent with safety and efficacy.

[02:00:33] Speaker 00:
I think appropriate with the word that we would use suitable or appropriate.

[02:00:36] Speaker 00:
That's a that is a dictionary definition of that dictionary just definition.

[02:00:40] Speaker 04:
The full definition says called for a suitable or appropriate in particular case colon the need for some end or purpose.

[02:00:49] Speaker 04:
You've abbreviated the dictionary definition.

[02:00:52] Speaker 00:
Let me just frame it this way.

[02:00:55] Speaker 00:
I'm going to go back to Zeneca.

[02:00:57] Speaker 00:
I'm going to go back to the manufacturing cases.

[02:00:59] Speaker 00:
I understand that the court thinks those are different.

[02:01:01] Speaker 00:
But just to explain the statutory definition there, there were changes that had to be made to the label there because there was a different manufacturing process or there was a different formulation of the drug.

[02:01:17] Speaker 00:
Fine.

[02:01:18] Speaker 00:
That requires a reading of the required because there's a different manufacturer to be read quite broadly.

[02:01:26] Speaker 04:
Why?

[02:01:27] Speaker 04:
Because that's a manufacturing process.

[02:01:29] Speaker 04:
That's narrow.

[02:01:31] Speaker 04:
It's a different manufacturer who's a different process.

[02:01:34] Speaker 04:
So we have to identify this different manufacturing process.

[02:01:36] Speaker 00:
A different optional process.

[02:01:39] Speaker 00:
A different optional process.

[02:01:41] Speaker 00:
It's an optional choice that the manufacturer made.

[02:01:44] Speaker 01:
I think we would all agree that any manufacturing changes have to be disclosed on a label.

[02:01:48] Speaker 00:
Sure, Your Honor, I agree.

[02:01:50] Speaker 01:
But there's no same manufacturer requirement in the statute.

[02:01:54] Speaker 01:
There's simply a same label requirement.

[02:01:56] Speaker 00:
Sure.

[02:01:57] Speaker 01:
But so we can have different processes.

[02:01:59] Speaker 01:
But if you use different ingredients or anything like that, you're going to have to disclose them.

[02:02:03] Speaker 01:
So I don't I think I think that the point here is it is very hard to anchor your argument, which takes the word required, pushes it away and it says,

[02:02:19] Speaker 01:
You can do anything you want, unless you can have any difference you want, unless it contravenes safety and efficacy.

[02:02:30] Speaker 00:
I don't think it's that broad, Your Honor.

[02:02:31] Speaker 00:
I think it's much narrower than that, in part because.

[02:02:34] Speaker 01:
Well, I guess appropriate, I mean, optional choices, design choices.

[02:02:39] Speaker 00:
Sure, Your Honor, but I mean, everyone agrees that manufacturers can have optional design choices?

[02:02:46] Speaker 01:
Yeah, but I don't think everyone agrees where that goes in the statute.

[02:02:49] Speaker 00:
finer, that's true, but it does as much damage to the statue to read those kind of exceptions into same as it does to read.

[02:02:58] Speaker 01:
So same as commonly determined, we have the same suit hypo here, that it goes to material relevance under the circumstances.

[02:03:07] Speaker 00:
I took the same suit, I would be the same means it has to be the same suit, not that it has to be the same suit except for maybe some de minimis changes, except well, who knows, maybe that's an important difference in the, I mean, I think the better way to read the statute.

[02:03:18] Speaker 04:
So you read same.

[02:03:20] Speaker 04:
in the statute as identical and any differences have to come within the exception?

[02:03:24] Speaker 00:
That's our understanding, Your Honor.

[02:03:26] Speaker 00:
And that is, I think, the best way to read the statutory scheme.

[02:03:29] Speaker 01:
That's just how same as in other parts of the Hatch-Waxman process.

[02:03:32] Speaker 00:
I'm not sure that's true, Your Honor.

[02:03:33] Speaker 00:
I mean, the same active ingredient means the same active ingredient, right?

[02:03:39] Speaker 00:
I don't think we would say that.

[02:03:41] Speaker 01:
I am not a chemist.

[02:03:44] Speaker 01:
I don't know that there's, that may just be a binary choice.

[02:03:48] Speaker 00:
I think FDA would be very concerned if they would say, well.

[02:03:51] Speaker 01:
But bioequivalence doesn't have to be.

[02:03:52] Speaker 01:
I mean, our Serrano decision said same there doesn't mean exactly the same.

[02:03:57] Speaker 00:
For bioequivalence, your honor.

[02:03:59] Speaker 00:
Because same doesn't appear in that provision.

[02:04:02] Speaker 00:
Same disrequirement.

[02:04:03] Speaker 00:
Not for bioequivalence, your honor.

[02:04:06] Speaker 00:
They have to be bioequivalent.

[02:04:07] Speaker 00:
They don't have to be the same.

[02:04:08] Speaker 00:
That was actually.

[02:04:08] Speaker 00:
Equivalent.

[02:04:09] Speaker 00:
But that's all.

[02:04:09] Speaker 01:
Bioequivalent.

[02:04:10] Speaker 01:
What does that mean?

[02:04:11] Speaker 01:
What does equivalent mean?

[02:04:13] Speaker 00:
Bioequivalent means that they can have differences in the formulation of the product.

[02:04:16] Speaker 01:
What does equivalent mean?

[02:04:17] Speaker 01:
The same?

[02:04:18] Speaker 00:
Sure.

[02:04:18] Speaker 00:
But I'm not saying there's not the same in the sense of the effect of the drug has to be the same.

[02:04:24] Speaker 00:
We have to be bio equivalent, I guess, to use the exact language.

[02:04:26] Speaker 00:
My point was that same is not being used there.

[02:04:29] Speaker 00:
Our understanding is that same means same.

[02:04:31] Speaker 00:
It has to be the same active ingredient.

[02:04:32] Speaker 00:
It has to be the same.

[02:04:33] Speaker 00:
The sameness requirement means identical.

[02:04:37] Speaker 00:
And if you have exceptions to that, the way that the exceptions work is they fit into the different manufacturer exceptions.

[02:04:42] Speaker 01:
Do you get their view that there are

[02:04:45] Speaker 01:
some stylistic exceptions to sameness.

[02:04:49] Speaker 01:
I mean, he's not saying identical.

[02:04:51] Speaker 01:
So the difference is they say identical has, same doesn't mean identical.

[02:04:57] Speaker 01:
It has some breathing room, but it's very small.

[02:04:59] Speaker 01:
And as for, I think when he sees de minimis, I think he would say,

[02:05:05] Speaker 01:
may be wholly unrelated to safety.

[02:05:07] Speaker 01:
I don't mean to put words in his mouth, but wholly unrelated to safety and ethics.

[02:05:10] Speaker 00:
Sure.

[02:05:10] Speaker 00:
But then you're just putting the same analysis into this, in the sameness requirement.

[02:05:13] Speaker 00:
It's a little easier to put it in the definition of sameness than it is required because... Your honor, if this court is going to say, look, the sameness requirement means it's pretty flexible here and there are a certain amount of changes to like stylistic choices that

[02:05:25] Speaker 00:
that the generic manufacturer can make, and also the different manufacturers can also apply.

[02:05:32] Speaker 01:
You're not making that argument.

[02:05:34] Speaker 01:
The agency hasn't made that argument.

[02:05:35] Speaker 01:
You've flatly rejected that argument.

[02:05:37] Speaker 01:
So we then all we have to do is interpret what required because you're a different manufacturer means.

[02:05:45] Speaker 00:
The reason that my friend in their side, I think is making the arguments about sameness is because even they understand that there are certain kind of stylistic choices that don't have to be replicated like for like in the, on the generic brand label.

[02:05:59] Speaker 00:
And so my point, and then as the colleague we illustrated, whether those things are really de minimis, inquires any number of factual determinations about whether they affect the safety and efficacy of the drug, including.

[02:06:10] Speaker 04:
Well, that goes to the definition of same.

[02:06:13] Speaker 04:
So under your interpretation,

[02:06:15] Speaker 04:
Is it correct that somebody who just changed the font on the label, now the label's not the same under your interpretation, and they do that because they just feel like it?

[02:06:27] Speaker 04:
That is required because it's a different manufacturer.

[02:06:30] Speaker 00:
Whether it would be appropriate would be analyzed under the different manufacturer.

[02:06:33] Speaker 04:
That is required because it's a different manufacturer.

[02:06:37] Speaker 04:
Let's say they're allowed to do it, and the rationale of the agency would be like, you can do it because this change of font is required because you're a different manufacturer.

[02:06:47] Speaker 04:
That would be illogical.

[02:06:48] Speaker 00:
I think it would fall under the different manufacturer exception.

[02:06:50] Speaker 04:
But that would be the reasoning.

[02:06:51] Speaker 04:
It would be because it would be... Changing this from bold to italic is required because you're a different manufacturer.

[02:06:56] Speaker 00:
I think it would be suitable because there's a new manufacturer.

[02:06:59] Speaker 00:
I think that's the best way to read that provision.

[02:07:02] Speaker 04:
Well, the text doesn't say suitable.

[02:07:03] Speaker 04:
It says required.

[02:07:04] Speaker 04:
So isn't that absurd that that's required because you're a new manufacturer, and so it's required that you change a font from bold to italic?

[02:07:12] Speaker 04:
Isn't that absurd?

[02:07:13] Speaker 00:
I don't think so, Your Honor.

[02:07:15] Speaker 00:
Again, I'll give another, I'll give another, I'll give another pitch.

[02:07:19] Speaker 00:
It was not working, but let's, let's try it again.

[02:07:21] Speaker 00:
Uh, I think the way to think about this is that particularly for labeling change features, right?

[02:07:27] Speaker 00:
Which is what we're talking about here.

[02:07:29] Speaker 00:
There are, there are things that have to be required.

[02:07:31] Speaker 00:
So if you look at 201.5, 14 CFR 201.56, 14 CFR 201.57, 14 CFR 101.200.

[02:07:41] Speaker 00:
there are any number of things that have to be included on a brand name drugs label for it to be approved.

[02:07:47] Speaker 00:
But that is not exclusive.

[02:07:48] Speaker 00:
There are also things that that manufacturer can make, design choices that manufacturer can make about its label and FDA can make the determination this doesn't have any concerns about safety and efficacy

[02:08:00] Speaker 00:
we will approve that brand name label.

[02:08:04] Speaker 00:
When a new manufacturer comes, the new manufacturer can make certain choices about those same design features.

[02:08:10] Speaker 00:
Because the presence of the new manufacturer means that that manufacturer can then make certain design choices.

[02:08:16] Speaker 00:
They are limited.

[02:08:18] Speaker 04:
But has that required?

[02:08:20] Speaker 00:
We think those changes are the ones that will be suitable because they do not affect the safety and efficacy of the drug.

[02:08:25] Speaker 02:
But what's the answer to Judge Pence?

[02:08:27] Speaker 01:
Has it expired?

[02:08:29] Speaker 01:
You know, I think they are suitable because- You want to read required for safety and efficacy?

[02:08:34] Speaker 00:
I think that to understand why a labeling change, or frankly any kind of change, would be appropriate underneath the statute when there's a new manufacturer, it will be because any changes that are being made are not changes that affect the safety and efficacy of the drug.

[02:08:48] Speaker 01:
So not required for safety and efficacy?

[02:08:51] Speaker 01:
Then we wouldn't even need a because clause, would we?

[02:08:55] Speaker 00:
No, I mean, I think the changes would be changes that would be appropriate or suitable because there's a new manufacturer.

[02:09:00] Speaker 00:
And the reason that they would be appropriate or suitable is because the changes do not affect the safety or efficacy of the drug.

[02:09:05] Speaker 02:
Just like a different- Why would Congress write a statute like that?

[02:09:09] Speaker 00:
I think the reason that Congress would write a statute is it has very much concerns about the reason that- Generics out fast.

[02:09:16] Speaker 02:
So it says identical label, but of course, you can't put

[02:09:22] Speaker 02:
You have to put the manufacturer's name on there.

[02:09:28] Speaker 02:
You have to put the dosage.

[02:09:32] Speaker 00:
Again, there's real concerns about, you know,

[02:09:38] Speaker 00:
ran a manufacturer leveraging the same labeling requirement to make labeling determinations.

[02:09:44] Speaker 02:
That was a decision Congress made.

[02:09:47] Speaker 02:
Congress said the same label as FDA has approved.

[02:09:50] Speaker 02:
I mean, Congress knew all that because the drug.

[02:09:55] Speaker 02:
The industry was before Congress and made its views well known.

[02:10:00] Speaker 02:
There were hearings.

[02:10:02] Speaker 02:
There were all kinds of objections.

[02:10:04] Speaker 02:
And Congress nevertheless chose that language and the president signed the bill.

[02:10:10] Speaker 00:
But FDA even this court has recognized in the DMS case that the purpose of the statute is to facilitate the introduction of generic drugs as efficiently as possible while ensuring that those drugs are safe and effective.

[02:10:22] Speaker 02:
And so the concern required is

[02:10:25] Speaker 02:
required as determined by FDA for the efficacy and safety of the drug.

[02:10:37] Speaker 02:
Yes or no first and then you can explain.

[02:10:39] Speaker 00:
I don't think it's quite right now.

[02:10:40] Speaker 00:
I would describe it.

[02:10:41] Speaker 00:
I think the way to think about it is when there are labeling changes that are being made by generic manufacturers,

[02:10:47] Speaker 00:
Changes that are made because there is a new manufacturer are required or suitable when those changes are permitted by the statute statute.

[02:10:56] Speaker 02:
All right, there's a cause.

[02:10:59] Speaker 02:
And there's no qualification to the cause.

[02:11:01] Speaker 02:
I mean, sometimes Congress.

[02:11:03] Speaker 00:
Rights clearly, we don't think they wrote so clearly here.

[02:11:08] Speaker 02:
Well.

[02:11:10] Speaker 02:
There is a way to say it wrote very clearly.

[02:11:14] Speaker 02:
And so if you have a different manufacturer, you have to change the name.

[02:11:19] Speaker 02:
If they're royalty issues, you have to change the name.

[02:11:22] Speaker 02:
That is your reading so much better as

[02:11:37] Speaker 02:
the better reading of the language that Congress wrote when it used fairly clear, unencumbered terms.

[02:11:49] Speaker 00:
I think the concern is a situation in which you have a branding manufacturer who has included, for example, on its drug label that the drug is halal or kosher.

[02:12:00] Speaker 00:
And then the generic manufacturer is then required to copy that, even though that

[02:12:06] Speaker 00:
Even when the drug is exactly the same, the idea is that the generic manufacturer shouldn't have to be jumping through these hoops to ensure that its label is exactly the same when the halal or kosher determination was entirely voluntary, which the chain here.

[02:12:18] Speaker 02:
One way FDA could prevent that problem is not approving labels that have

[02:12:25] Speaker 02:
kosher that have whatever it is.

[02:12:30] Speaker 00:
And this is the same question that Judge Pan just asked.

[02:12:32] Speaker 00:
I think that misunderstands FDA's role in approving brand name drug labeling.

[02:12:38] Speaker 00:
FDA determination is, is this brand label to suppose safety and efficacy concerns?

[02:12:43] Speaker 00:
The answer to that is no.

[02:12:45] Speaker 00:
And there's certain information that FDA requires to be on prescription drugs.

[02:12:49] Speaker 00:
I just cited several provisions.

[02:12:50] Speaker 00:
But when FDA, when a brand name drug includes voluntarily, which was the case here, no one doubts that there's not a braille requirement.

[02:12:58] Speaker 00:
Vanda just wanted to do this.

[02:13:00] Speaker 04:
Right, but FDA approved it and for a safety related reason.

[02:13:04] Speaker 00:
That's not true, Your Honor.

[02:13:05] Speaker 04:
It's in the record.

[02:13:07] Speaker 04:
Safety is what FDA said.

[02:13:09] Speaker 00:
No, the concern was, does adding information to this raise safety concerns?

[02:13:13] Speaker 00:
It did a comprehension study because it said, look, you're voluntarily including this new information.

[02:13:19] Speaker 00:
We have to make a risk-based assessment to determine whether it would add any safety concerns.

[02:13:24] Speaker 00:
And it deemed the resulting study was acceptable.

[02:13:29] Speaker 02:
I know, but FDA knew, because the language was there, that if you approve the label,

[02:13:36] Speaker 02:
And the generic was going to have to have the same label except, you know, the manufacturer's name.

[02:13:46] Speaker 00:
I think there's real concern.

[02:13:47] Speaker 00:
There'd be a real knock on a fact chart if the idea was that the FDA had to go around and try to police labeling.

[02:13:55] Speaker 02:
Not go around.

[02:13:55] Speaker 02:
They're coming to you.

[02:13:56] Speaker 02:
They can't do anything until you approve it.

[02:13:59] Speaker 00:
You don't have to go anywhere.

[02:14:01] Speaker 00:
My friend the other side will agree with this.

[02:14:02] Speaker 00:
The nature of approval of brand name drug labeling is that brand name drugs have considerable discretion in the things that they include above and beyond the required information.

[02:14:12] Speaker 02:
The point is, Congress passes a statute.

[02:14:15] Speaker 02:
We want these generics out fast.

[02:14:18] Speaker 02:
And FDA loads up the label for the pioneer with all this stuff.

[02:14:24] Speaker 02:
And of course, that's going to make it more difficult for the generics because it's going to cost them more money to do all this other stuff.

[02:14:32] Speaker 00:
It's exactly right.

[02:14:33] Speaker 02:
All I'm getting is this is not, in my view, and I may be wrong, but it's not a view where FDA wasn't on full notice of what Congress meant when it said the same label except

[02:14:49] Speaker 02:
All right?

[02:14:50] Speaker 02:
And the notion that it meant anything more than identifying who the manufacturer is, it seems to me, is a stretch.

[02:14:59] Speaker 02:
And I don't see it saying, unless FDA doesn't think this is suitable or necessary.

[02:15:05] Speaker 02:
That's not what it said.

[02:15:06] Speaker 00:
The consequence of the decision, the consequence of reading the different manufacturer exceptions as narrowly as the other side does,

[02:15:12] Speaker 00:
would be that a brand name drug can come to FDA and say, let's include all this extraneous information.

[02:15:19] Speaker 00:
FDA can say, look, I don't think any of this is important to the safety and efficacy of the drug.

[02:15:23] Speaker 00:
But because at the end of the day, the brand name manufacturer is the one who bears the burden of the label, we are going to approve it because we think it's permissible.

[02:15:31] Speaker 04:
You don't have to.

[02:15:31] Speaker 04:
You can say we're not going to approve all that.

[02:15:33] Speaker 00:
Because then every generic drug has to have it.

[02:15:36] Speaker 00:
I think there are legitimate limits on FDA's ability to

[02:15:41] Speaker 00:
to disapprove a label when there is otherwise true information on the label, but it's just not necessary to the drug safety and efficacy.

[02:15:50] Speaker 01:
You cannot reject it?

[02:15:52] Speaker 01:
Let me just be clear about my question, because this has been interesting for me.

[02:15:57] Speaker 01:
And that is, so when the name brand comes in, your question is, does it have the 45 things we require and the fonts and bolds that we require?

[02:16:09] Speaker 01:
Precisely.

[02:16:11] Speaker 01:
And if it does, then with respect to decorations, extra words, trademarks, these types of things, all you ask is does the presence of that additional, not FDA-required information impede safety and efficacy by obscuring the label, confusing the consumer?

[02:16:32] Speaker 01:
If it doesn't do those things, you have to let it go?

[02:16:36] Speaker 00:
I think the way to think about it is,

[02:16:39] Speaker 00:
Yes, with additional things, right?

[02:16:42] Speaker 00:
Is this misbranded in some way?

[02:16:44] Speaker 00:
Is this untruthful or misleading?

[02:16:47] Speaker 01:
I think I might be so, or in part, I'm trying to understand the baseline process.

[02:16:53] Speaker 01:
They have to check the boxes and then they have to not do anything more to the label that would make the label no longer accurate, safe, effective in communicating what you require to be communicated.

[02:17:10] Speaker 00:
I don't want to stand at the podium and say, this is forever and all time, all the ways in which FDA can do this.

[02:17:15] Speaker 00:
But I think there are limits on FDA's ability to tell brand name drugs you can include with otherwise truthful information that doesn't have a negative effect on the safety and efficacy, like Braille.

[02:17:27] Speaker 00:
That's exactly what happened here.

[02:17:30] Speaker 00:
Vanda voluntarily came.

[02:17:32] Speaker 02:
You cannot do that?

[02:17:33] Speaker 02:
You have no authority to do that?

[02:17:35] Speaker 00:
There are limits on FDA's authority.

[02:17:37] Speaker 02:
And those limits where?

[02:17:39] Speaker 00:
I think the grounds for disapproving a label or that they are misleading or they do not have, you know, they're not necessarily they're not meeting the safety and efficacy requirements for a drug fall within.

[02:17:49] Speaker 02:
Those statements, those words used in the regulation, you can't do it.

[02:17:55] Speaker 00:
I think there's a limit or concern about FDA's authority to do so.

[02:17:59] Speaker 02:
A limit or concern?

[02:18:02] Speaker 02:
Is the concern a legal one or a practical one?

[02:18:05] Speaker 00:
Yes.

[02:18:05] Speaker 00:
No, a legal concern.

[02:18:06] Speaker 00:
A legal concern about whether saying you cannot include this information would be something that would be challengeable by the brand name manufacturer.

[02:18:14] Speaker 01:
I mean, again, this is why... What does the statute say the tests are for?

[02:18:20] Speaker 01:
They you've you've checked all of our boxes, you know, the right fonts and all these things that we've required all of those are done.

[02:18:28] Speaker 01:
But you've added this extra thing.

[02:18:32] Speaker 01:
Hello.

[02:18:36] Speaker 00:
I don't have the statutory language.

[02:18:40] Speaker 00:
I think the concern is there are grounds for disapproving a new drug application.

[02:18:45] Speaker 00:
For example, the drug is misbranded.

[02:18:47] Speaker 00:
It doesn't meet the requirements for having the station.

[02:18:50] Speaker 00:
I think the concern is there may not be clear statutory grounds to deny something just because it wanted to include Braille.

[02:18:57] Speaker 01:
Instead of what they did here, they had put in Braille.

[02:19:02] Speaker 01:
They had everything

[02:19:05] Speaker 01:
Roman print, is that what we call it?

[02:19:07] Speaker 00:
Roman script, I think.

[02:19:08] Speaker 01:
Roman script.

[02:19:09] Speaker 01:
And then in Braille, they put these words, down below everything, not obscuring anything.

[02:19:18] Speaker 01:
And it said, Banda is the best.

[02:19:23] Speaker 01:
Just in Braille.

[02:19:25] Speaker 01:
Now,

[02:19:27] Speaker 00:
Are drugs the best maybe?

[02:19:29] Speaker 01:
It's not going to help because the next man, the generic, then the person will think they're... I want them to have to put on all the generic labels that Vanda is the best.

[02:19:38] Speaker 00:
The only reason I'm resisting the hypo is just because I imagine one of the answers they're going to give would be that they can't use Vanda on the generic drugs, just like they can't... Teva couldn't have Vanda on Teva's drug label.

[02:19:48] Speaker 00:
You have to obviously change that.

[02:19:50] Speaker 00:
Okay.

[02:19:50] Speaker 02:
Generics bad.

[02:19:53] Speaker 02:
They couldn't say just as good.

[02:19:55] Speaker 00:
Generics bad maybe.

[02:19:59] Speaker 01:
Would you be able to reject generics bad?

[02:20:06] Speaker 00:
I'm not sure.

[02:20:08] Speaker 00:
I'm not sure definitely for the hypothetical, but I think that that is the type of concern that FDA has is that you have information that is extraneous or not necessary.

[02:20:18] Speaker 00:
And I think the easiest example is something like, you know, you can imagine brand name says we're going to have like an incredibly complex hologram on our label, right?

[02:20:29] Speaker 00:
Because we just think that would be, we think that's great.

[02:20:31] Speaker 00:
We think that's part of what like, it helps our marketing, whatever it may be, right?

[02:20:36] Speaker 00:
And then you're going to force

[02:20:38] Speaker 00:
It doesn't have any safety and efficacy.

[02:20:39] Speaker 01:
It takes you to Vanda's website.

[02:20:41] Speaker 00:
Again, I'm resistant to any hypotheticals that are going to take you to... It doesn't say Vanda on there.

[02:20:46] Speaker 00:
Potentially.

[02:20:46] Speaker 01:
The QR code you hold on your phone has got to get to Vanda's website.

[02:20:49] Speaker 01:
Exactly.

[02:20:49] Speaker 01:
The FDA will say Vanda is best.

[02:20:51] Speaker 01:
I shouldn't say Vanda.

[02:20:52] Speaker 01:
They're not doing this.

[02:20:53] Speaker 00:
I know, I know.

[02:20:54] Speaker 01:
Company X is best.

[02:20:56] Speaker 00:
QR codes are another example.

[02:20:58] Speaker 00:
Yes, QR codes have been included on brand name drop labels.

[02:21:03] Speaker 00:
not deemed to be necessary to the safety and efficacy of the drug, but also not raising concerns.

[02:21:08] Speaker 00:
And it's another example where FDA has said to a generic manufacturer, you do not have to replicate that information on.

[02:21:15] Speaker 04:
So why isn't a better reading of the statute to say to address these concerns you have that that all goes to sameness.

[02:21:21] Speaker 04:
And if there are de minimis differences between your label and their label, it's still the same for our legal purposes.

[02:21:29] Speaker 04:
And then reserving

[02:21:31] Speaker 04:
The second part, which is the exception for different manufacturers for things that are necessary for different manufacturers, like you've manufactured this differently.

[02:21:39] Speaker 04:
Why isn't that just a better reading?

[02:21:42] Speaker 04:
It feels very difficult to get to your reading.

[02:21:45] Speaker 04:
And so why don't we just adopt the easier reading?

[02:21:47] Speaker 00:
I understand that FDA has long been understood that the changes that may exist between labels are best understood through the different manufacturers.

[02:21:59] Speaker 00:
I understand the question is, well, maybe that actually there's some kind of sameness is doing some of the work here.

[02:22:05] Speaker 04:
It's a statutory interpretation now.

[02:22:07] Speaker 00:
But I think there are a range of different changes that are made through different manufacturer exceptions.

[02:22:12] Speaker 00:
I keep going back to Zeneca, though that doesn't seem to be any much purchase.

[02:22:15] Speaker 01:
They're all manufacturing things.

[02:22:19] Speaker 00:
But just that there are different choices that are made by generic manufacturers.

[02:22:24] Speaker 00:
And the way in which FDA has understood them is that when generic manufacturers are making choices about their drug or their product manufacturing or their label, then you understand it through the different manufacturer exceptions.

[02:22:35] Speaker 04:
It's just there's no limits to that that's textually based.

[02:22:38] Speaker 04:
It's basically anything they want to do that they think is suitable, they can do.

[02:22:42] Speaker 04:
And there's no textual restraint on it.

[02:22:44] Speaker 04:
But then you import an atextual, unless it relates to safety.

[02:22:48] Speaker 04:
It's just really hard to reconcile it with the statute.

[02:22:50] Speaker 00:
I don't think that's exactly right.

[02:22:52] Speaker 04:
I mean... Like Tommy, where in the statute there are limits to what you just said.

[02:22:56] Speaker 04:
That anytime a different manufacturer wants to make any change they want that they think is suitable, they can do so except when

[02:23:04] Speaker 00:
No, except that there is any amount of information.

[02:23:08] Speaker 00:
I think the safety and efficacy requirement is a real limit.

[02:23:12] Speaker 04:
Where in the statute is that though?

[02:23:15] Speaker 00:
So, a few things.

[02:23:18] Speaker 04:
Where in this statutory provision?

[02:23:21] Speaker 00:
I agree.

[02:23:23] Speaker 00:
I'm not disagreeing that the version doesn't say safety and efficacy.

[02:23:27] Speaker 04:
Right.

[02:23:27] Speaker 04:
So that's why it's so difficult to find any limit to your interpretation.

[02:23:31] Speaker 00:
My point is that the limit comes from the fact that

[02:23:36] Speaker 00:
The information that has to be required on a drug label to ensure that a drug is safe and effective is robust.

[02:23:42] Speaker 00:
And for prescription drugs like these, it is set out extensively in FDA regulations.

[02:23:46] Speaker 04:
No, but we're just interpreting this one provision, and your interpretation doesn't really work.

[02:23:52] Speaker 04:
And I do wonder, too, why FDA wants what you're proposing, because it seems to me that the easier way to do this

[02:24:00] Speaker 04:
Apropos to what Judge Rogers was saying is we want generic approvals to be streamlined, is that it's the same.

[02:24:08] Speaker 04:
And the only way it's not allowed to be the same is we look to this one thing, which is easy to determine, and that's it.

[02:24:15] Speaker 04:
But what you're suggesting is every time there's a change to the label,

[02:24:19] Speaker 04:
the FDA has to do some kind of new assessment about whether it goes to safety and efficacy.

[02:24:24] Speaker 04:
And I would think that that is contrary to the whole point of having a more streamlined process for generics.

[02:24:29] Speaker 00:
No, I mean, whenever a generic submits an application and has any differences in its labeling, it has to identify all those differences.

[02:24:35] Speaker 00:
So, I mean, part of the analysis is that.

[02:24:37] Speaker 04:
But then either the agency just has to say, this is required because there are different manufacturers or not.

[02:24:44] Speaker 04:
And if it's not, you don't get to do it.

[02:24:45] Speaker 04:
But under your reading, every single change, the agency has to determine whether it goes to safety and efficacy.

[02:24:52] Speaker 04:
That does not seem like what you should want to be doing.

[02:24:55] Speaker 00:
I understand that's superficially appealing, but it doesn't.

[02:24:57] Speaker 00:
You just import the same problem into the same misreferring.

[02:25:00] Speaker 01:
I mean, again, to go back to the example... You have to decide whether every label is...

[02:25:06] Speaker 01:
permissible under the FDA and so everyone has to be, it can't interfere with safety and effectiveness.

[02:25:13] Speaker 00:
Sure.

[02:25:13] Speaker 01:
No label goes out generic or otherwise if the FDA deciding that this does not impair safety and effectiveness.

[02:25:20] Speaker 01:
It has required things and it doesn't

[02:25:22] Speaker 00:
My point was just that you import the same problem into the same analysis.

[02:25:25] Speaker 04:
It's assumed safe because the pioneer drug label was approved by FDA and it's safe.

[02:25:30] Speaker 04:
So if it's the same, it's safe.

[02:25:32] Speaker 04:
There's a presumption if it's the same.

[02:25:34] Speaker 00:
My point was what I'm fighting right now, Your Honor, is that...

[02:25:39] Speaker 00:
Under the shirt, if you mean same means same, but the other side has said, actually same doesn't mean same.

[02:25:45] Speaker 00:
It doesn't mean identical.

[02:25:46] Speaker 00:
Same encompasses any number of kind of diminished exceptions that they think are actually fine because they can't really.

[02:25:51] Speaker 04:
And so then you say, well, diminished ones don't go to safety of efficacy.

[02:25:55] Speaker 00:
So my point is that then you'd have to make that determination.

[02:25:57] Speaker 00:
Judge Malik gave the example of a change in font that actually might very well affect the safety and efficacy of the drug because it may be for a drug product that's for individuals who are dyslexic.

[02:26:08] Speaker 00:
And so now if you're saying, well, is that sufficiently affecting the safety and efficacy of the drug to be same anymore, you're just doing the same analysis in this digital staffer story provision.

[02:26:20] Speaker 00:
That is frankly the exact same analysis that FDA did here.

[02:26:24] Speaker 00:
Is this something that can be changed?

[02:26:28] Speaker 00:
Is this something that was required for approval in the first instance?

[02:26:30] Speaker 00:
No, it wasn't a condition of approval.

[02:26:31] Speaker 00:
It was entirely voluntary.

[02:26:33] Speaker 04:
Why did they say this is the same?

[02:26:34] Speaker 04:
It's the same.

[02:26:35] Speaker 04:
It's just a different label.

[02:26:36] Speaker 04:
It's Braille.

[02:26:37] Speaker 04:
I mean, I think that there are problems with that.

[02:26:39] Speaker 04:
But hypothetically, if they wanted to go that route, why wouldn't they take that route, which is easier as a statutory interpretation?

[02:26:48] Speaker 00:
If this court wants to affirm on that's how it understands the statute, perhaps, but I'm saying our FDA's understanding is that the analysis is properly done through the different manufacturer exception because determining whether something is safe and effective on a different, whether a change is appropriate because it doesn't affect the safety and efficacy of the drug is properly done under the different manufacturer exception.

[02:27:09] Speaker 00:
And my response was just that if you are going to say, well, actually sameness does that work, you import the same problem into the sameness analysis.

[02:27:17] Speaker 01:
not the same textual problem.

[02:27:21] Speaker 01:
Can I ask you just two things?

[02:27:23] Speaker 01:
So you and your breed, I think intervenors as well, talk about trade dress and things like that.

[02:27:32] Speaker 01:
Are there any cases that have said trade dress falls within the required exception, manufacturer required because of manufacturer exception?

[02:27:43] Speaker 00:
not aware of a case.

[02:27:44] Speaker 01:
There's been no litigation over that.

[02:27:46] Speaker 00:
I'm not aware of any.

[02:27:47] Speaker 01:
The only litigation over this exception has involved with the ones that we've seen are things that involve changes in the manufacturing process itself.

[02:27:56] Speaker 00:
With the caveat that there are also different manufacturers have been also encompassed changes due to intellectual property change like patent protections.

[02:28:03] Speaker 00:
So Novartis and BMS were other decisions like that.

[02:28:06] Speaker 01:
And then on the

[02:28:10] Speaker 01:
The fact that you now have a generic, what they want is for the generic to put the active ingredient in Braille, even though the active ingredient on their label is not in Braille.

[02:28:30] Speaker 01:
You're sorry, I think problems that are they asking for different labels rather than the same label?

[02:28:36] Speaker 01:
I mean, trying to figure out how to think about that because it feels very different.

[02:28:39] Speaker 00:
FDA approved MSN because under applying the same reasoning as it approved here, whether to include Braille or not was a discretionary choice that Vanda made.

[02:28:49] Speaker 00:
And so.

[02:28:49] Speaker 00:
the generic manufacturer is allowed to make a decision about whether to include that on its generic label.

[02:28:56] Speaker 00:
But I think that the question that you raise points to the fact that if you just think if the carve-outs are going to be in the sameness problem, then you have this exact issue, right?

[02:29:06] Speaker 00:
Because those aren't the same, obviously.

[02:29:09] Speaker 00:
And so now you have to also define not only are these things identical, but also what is the quality of sameness that we are evaluating?

[02:29:16] Speaker 00:
Is it just having braille?

[02:29:17] Speaker 00:
Is it having the exact

[02:29:19] Speaker 00:
same information in Braille.

[02:29:21] Speaker 00:
I mean, I think the better way to understand the statute is to channel that inquiry into the different manufacturers.

[02:29:26] Speaker 04:
We're standing as what's required because it's a different manufacturer.

[02:29:29] Speaker 04:
It's required that you can't say Hetlios because you're a different manufacturer.

[02:29:34] Speaker 00:
Sure.

[02:29:35] Speaker 00:
We agree with that.

[02:29:37] Speaker 00:
But those aren't also the same.

[02:29:41] Speaker 00:
The reason why

[02:29:43] Speaker 00:
Sorry, those also aren't the same, right?

[02:29:46] Speaker 04:
The answer here would be you don't want the same label.

[02:29:48] Speaker 04:
They don't have to be the same if it's required because they're different manufacturers.

[02:29:52] Speaker 04:
And why isn't this required?

[02:29:54] Speaker 04:
Because they can't say helios.

[02:29:55] Speaker 00:
I think that's right.

[02:29:57] Speaker 00:
Sorry, maybe misunderstood the question.

[02:29:59] Speaker 01:
They can't say helios, but they don't have to say in Braille an active ingredient.

[02:30:06] Speaker 01:
that isn't in Braille even on the original label.

[02:30:09] Speaker 01:
They could just have the active ingredient listed up there.

[02:30:12] Speaker 01:
That's what generics are, is just the active ingredient.

[02:30:15] Speaker 01:
They're generics, they're not name grants.

[02:30:17] Speaker 01:
So that's what they have up there, but it's not their name.

[02:30:20] Speaker 01:
It's not Teva's name for this drug.

[02:30:22] Speaker 01:
It's the generic active ingredient is what it is.

[02:30:27] Speaker 01:
And that's how they label it because they're generics, but it's not, you know, the name of the, how you identify the manufacturer is Teva, Fanda.

[02:30:36] Speaker 00:
Yes, your honor.

[02:30:36] Speaker 00:
That's, that is, I'm not sure the question.

[02:30:39] Speaker 00:
My argument, no one's challenging that.

[02:30:43] Speaker 01:
It just feels like an argument that they, that the rationale would be, well, you don't want the same label.

[02:30:48] Speaker 01:
You actually want us to take something that is not in Braille on your label and require it to be in Braille on other people's labels.

[02:30:54] Speaker 01:
And if now, if you think it's all promoting safety, then you've got to believe a problem.

[02:30:58] Speaker 01:
If you don't think it promotes safety, then you're just asking for a different label, not the same label.

[02:31:03] Speaker 01:
Cause I get that you have to take Helios

[02:31:06] Speaker 01:
I can't keep saying it.

[02:31:09] Speaker 01:
But that doesn't mean, of course, it does not mean for a generic that you have to now have your own generic name up there.

[02:31:17] Speaker 01:
You just have to take out the rename brand and have everything else that we require you to have.

[02:31:23] Speaker 01:
And anything, let's say the 20MG, maybe when you have to decide whether that has to be in Braille.

[02:31:30] Speaker 01:
But it doesn't seem like they're asking for the same label.

[02:31:34] Speaker 01:
And asking for a change that isn't, from their point, that is not made on theirs and has nothing, and it's not subbing in an equivalent thing, right?

[02:31:45] Speaker 01:
If they wanted Teva in Braille, that might be closer to equivalent, but subbing in, you've got to put in Braille, the active ingredient doesn't feel like a fair substitute at all.

[02:31:59] Speaker 01:
It doesn't feel like same or anything.

[02:32:01] Speaker 01:
Well, why isn't it that, I'm just, wait, can I just?

[02:32:05] Speaker 00:
I'm not sure how to answer the question, but here's why.

[02:32:09] Speaker 00:
In our view, we agree that the generic manufacturer that does include Braille, so MSN in this case, or the other generic manufacturer, could not include Helios.

[02:32:18] Speaker 00:
We think that it was an appropriate labeling feature to include, that the generic had some amount of discretion to understand how to make that change, and including the active ingredient was an appropriate way to kind of change from Helios.

[02:32:34] Speaker 00:
Like, that seems, that's our, that was FDA's understanding of the best way to accommodate the fact that Helios could not be included.

[02:32:41] Speaker 02:
Required.

[02:32:43] Speaker 02:
Well, you're- Because it would be misleading.

[02:32:45] Speaker 00:
We don't think you had to conclude Braille at all.

[02:32:48] Speaker 02:
No, no, no.

[02:32:48] Speaker 02:
I thought you said we were talking about not including Helios.

[02:32:53] Speaker 02:
I didn't think you were talking about Braille yet.

[02:32:55] Speaker 02:
No, I mean- First thing, you put the active ingredient on the label.

[02:33:00] Speaker 00:
I took the question to be about Braille, but maybe I misunderstood it.

[02:33:02] Speaker 01:
All right.

[02:33:03] Speaker 01:
I was combining the two things.

[02:33:05] Speaker 01:
So Helios has to come off.

[02:33:07] Speaker 00:
Always has.

[02:33:08] Speaker 01:
Has to come off.

[02:33:10] Speaker 01:
Vanda has to come off.

[02:33:12] Speaker 00:
We think that's an appropriate application of the different manufacturers.

[02:33:15] Speaker 01:
Vanda has to come off on the generics.

[02:33:17] Speaker 00:
Yes, I agree.

[02:33:19] Speaker 01:
Yes, and Vanda have to come off.

[02:33:21] Speaker 01:
Those are required to come off.

[02:33:24] Speaker 01:
And so those come off.

[02:33:29] Speaker 01:
But what their argument is

[02:33:32] Speaker 01:
Wow, well, let's have something else in Braille instead.

[02:33:36] Speaker 01:
And they want to put that under the same labeling requirement.

[02:33:39] Speaker 00:
And I guess my question- Sorry, to be sure.

[02:33:42] Speaker 00:
Vanda says that you have to then include the brand name drug on the, sorry, the active ingredient on the generic drug.

[02:33:50] Speaker 01:
In lieu of, since you don't have a name brand, you're a generic, you have to put this other thing.

[02:33:59] Speaker 01:
We have on our label, but haven't put in Braille.

[02:34:02] Speaker 01:
We have to put that in Braille.

[02:34:03] Speaker 01:
You have to put that in Braille.

[02:34:06] Speaker 01:
You generic have to put it in Braille, even though we did not, because you got to have something in Braille that's that's sort of parallels what we had in Braille as in the big word on your label.

[02:34:19] Speaker 01:
And that I just I don't understand why that's just not even an option.

[02:34:24] Speaker 01:
I mean, that doesn't feel it.

[02:34:26] Speaker 01:
Step one, sameness.

[02:34:29] Speaker 01:
You're not asking for the same thing.

[02:34:31] Speaker 01:
You lose on that.

[02:34:32] Speaker 01:
And then this case would be about 20 mg in braille.

[02:34:36] Speaker 00:
They very may well lose on that, I guess.

[02:34:41] Speaker 01:
You seem to want to shove that into your different manufacturer thing.

[02:34:44] Speaker 01:
And that one seems like you can take any definition you want of same, and those are not equivalent substitutions.

[02:34:52] Speaker 00:
The way I would understand it and just like, for example, the way I think FDA understood when it was approving MSN's label was that.

[02:34:59] Speaker 00:
Braille is not required at all, obviously.

[02:35:01] Speaker 00:
And that if you're going to include Braille, then there's some amount of leeway that the generic manufacturer has as to how to reflect the Braille on its label.

[02:35:12] Speaker 02:
We want to put everything under the manufacturer exception.

[02:35:15] Speaker 02:
And what we're trying to get you to focus on is something else.

[02:35:20] Speaker 02:
I understand.

[02:35:21] Speaker 02:
Because you keep using the word appropriate.

[02:35:24] Speaker 02:
And we want to know, is it the same or is it required?

[02:35:29] Speaker 02:
And so that's why we keep pestering you with questions.

[02:35:35] Speaker 04:
So why isn't it the case that just, I'm just trying to apply the language of the statute.

[02:35:42] Speaker 04:
These are different.

[02:35:43] Speaker 04:
Okay.

[02:35:43] Speaker 04:
Because the pioneer label has Braille, it says Hetlio's 20 milligrams in Braille.

[02:35:50] Speaker 04:
and the generic has no braille.

[02:35:55] Speaker 04:
Now, applying the statute, it has to be the same except for changes that are required.

[02:36:00] Speaker 04:
You have to take off Hetlios that's required.

[02:36:03] Speaker 04:
It's a different manufacturer.

[02:36:05] Speaker 04:
But you don't have to take off the braille because MSN shows that you can have your identifying information in braille.

[02:36:12] Speaker 04:
But you do have to take off

[02:36:15] Speaker 04:
And what you put in its place, they happen to choose to has a melting on whatever it is.

[02:36:20] Speaker 04:
It's whatever identifies the drug, but it has to be in Braille because as a manufacturer, that doesn't require you to remove the Braille.

[02:36:27] Speaker 00:
I just think, I think the way the problem with that is it raises your, the move, I understand the statutory move is to move everything to sameness.

[02:36:37] Speaker 00:
And the problem is, I think you just, I think so.

[02:36:43] Speaker 00:
Maybe just let me try to answer it, which is that.

[02:36:48] Speaker 00:
that then the argument is that the sameness is as to rail, right?

[02:36:55] Speaker 00:
That's what has to be the same under the view, even though everyone agrees that Hetlius and Talisman are not, the actual act of ingredient are not the same, right?

[02:37:05] Speaker 00:
And so,

[02:37:06] Speaker 00:
Our view would be that raises hard questions about whether those are actually the same or not.

[02:37:12] Speaker 04:
And the better way to rail is the same raises a hard question.

[02:37:16] Speaker 00:
Well, the relevant rail in each label, well, the relevant inquiry is.

[02:37:22] Speaker 00:
the brailness, sameness, right?

[02:37:24] Speaker 00:
Or just the information itself.

[02:37:26] Speaker 00:
As the distributor pointed out, this is just repeating information that's already on the thing.

[02:37:29] Speaker 04:
Says Congress.

[02:37:30] Speaker 04:
But it's modified by required because you're a different manufacturer, and the brailness doesn't depend on which manufacturer it is.

[02:37:37] Speaker 04:
But Hetlios does, using the word Hetlios does.

[02:37:41] Speaker 04:
So you have to change Hetlios, but you don't change the brailness, the fact that it's in braille.

[02:37:46] Speaker 04:
You don't have to change anything.

[02:37:47] Speaker 04:
Because as a new manufacturer, it has to be the same.

[02:37:50] Speaker 04:
There has to be brailness.

[02:37:51] Speaker 00:
Earlier, we were just saying that Braille is effectively just a stylistic choice like a font.

[02:37:56] Speaker 00:
And everyone agrees that you could change the stylistic font, right?

[02:37:59] Speaker 00:
And that would still be the same.

[02:38:00] Speaker 04:
If Braille was just a stylistic choice like a font, why was there a back and forth between the agency and Vanda when they wanted to include Braille with discussion about safety?

[02:38:10] Speaker 00:
To make sure that it didn't oppose a risk.

[02:38:13] Speaker 00:
It was a risk assessment to make sure there wasn't- It enhanced safety.

[02:38:16] Speaker 04:
And I read the quote before, but I'll try to find it again.

[02:38:20] Speaker 04:
FDA inquired, had you considered other important information, such as the established name or usual dosage, should also appear in Braille on the container to promote the safe use of the product?

[02:38:30] Speaker 04:
It was an affirmative safety thing.

[02:38:32] Speaker 04:
No, that wasn't a question.

[02:38:34] Speaker 04:
It was a question, but I'm just saying that safety was an issue.

[02:38:37] Speaker 04:
There was no finding.

[02:38:38] Speaker 00:
FDA was absolutely clear, and I'll point to 922 of the JAA and its denial of this position, that it never thought that Braille was in any way necessary to the drug safe and effective use.

[02:38:48] Speaker 04:
Not necessary, but it promoted it.

[02:38:50] Speaker 00:
I don't think that's right.

[02:38:51] Speaker 04:
You're considering whether it would promote safety for good reason.

[02:38:54] Speaker 00:
I mean, more than 90% of people who are visually impaired do not read Braille, right?

[02:38:58] Speaker 00:
And Braille is never required on any drug.

[02:39:02] Speaker 04:
When they did their study, it helped people identify the drug because other drugs don't have Braille.

[02:39:07] Speaker 04:
So they can tell even the ones who don't read Braille could tell that this flows.

[02:39:10] Speaker 00:
The purpose of that assessment was to determine a safety risk and to determine there is not a safety risk, which is I think brought to the broader point.

[02:39:18] Speaker 00:
The way in which FDA does its brand name drug approval is to say, is there a certain information that has to be on there because it's required for a drug to be safe and effective?

[02:39:27] Speaker 00:
Dosage form, safety warnings, strength, so on and so forth.

[02:39:30] Speaker 00:
Those are all set out in extensive regulations, including the format of that information.

[02:39:34] Speaker 00:
But then when you elect to include voluntary information,

[02:39:37] Speaker 04:
But to get back to this particular voluntary information, there was an approval process.

[02:39:41] Speaker 04:
You approved it.

[02:39:42] Speaker 04:
And there was a safety discussion, even if it wasn't a finding that was necessary for safety.

[02:39:48] Speaker 04:
And so this is not like changing the font.

[02:39:53] Speaker 04:
This is a substantive thing.

[02:39:54] Speaker 00:
Not in FDA's view, Your Honor.

[02:39:58] Speaker 00:
It's not viewed as a substantive thing.

[02:40:00] Speaker 00:
You think it is just like changing the font?

[02:40:02] Speaker 00:
Your Honor, it is a- Oh, congressman's view.

[02:40:06] Speaker 01:
Why did it hang on?

[02:40:07] Speaker 01:
Let him just how many just finishes?

[02:40:10] Speaker 01:
And it's my fault.

[02:40:11] Speaker 01:
Leslie, I'm letting him.

[02:40:14] Speaker 00:
FDA's view is this was not necessary in any way to the safe and effective use of the drug as the district court recognized.

[02:40:19] Speaker 00:
It's just a volunteer way of including some information, information that on its own is not at all necessary.

[02:40:26] Speaker 00:
It's not alone sufficient to ensure the drug is used safely and effectively.

[02:40:31] Speaker 00:
And so

[02:40:32] Speaker 00:
I think this is very much like a highlight of information.

[02:40:37] Speaker 00:
It's very much like certain font choices that you might make to present information.

[02:40:42] Speaker 00:
And that's our, that has been, I think the principal point is that

[02:40:48] Speaker 00:
All of that analysis, we think, is best done in a different manufacturer exception.

[02:40:51] Speaker 00:
But to the extent that you think, well, those changes are permissible because they are not the same, I think you import the same problems into the sameness analysis because you have to make a determination.

[02:41:01] Speaker 00:
Is this like font?

[02:41:02] Speaker 01:
I think you could ask a five-year-old whether a label, you hold him a piece of paper and it says Helios in big font letters.

[02:41:14] Speaker 01:
Then you have another 1 that says, right?

[02:41:19] Speaker 00:
I also mispronounce it all the time.

[02:41:21] Speaker 00:
That's why I use active ingredient and say.

[02:41:26] Speaker 01:
Are these the same?

[02:41:29] Speaker 01:
I gotta think 100 out of 100 are going to say no.

[02:41:33] Speaker 00:
I guess the point, Your Honor, is that the court is going to say that you can make changes, that the generic manufacturer can always make changes to its kind of elective, the elective stylistic choices that the brand name manufacturer has made.

[02:41:44] Speaker 00:
Then I think this is very much like that.

[02:41:47] Speaker 00:
I think that's- I'm not even there.

[02:41:48] Speaker 01:
I'm just- I know.

[02:41:50] Speaker 01:
I'm just saying, it's one thing to say you have to take Helios off.

[02:41:57] Speaker 01:
That's required because they're a new manufacturer.

[02:41:59] Speaker 01:
It's an entirely different thing to say, this thing that we have little print on our label, now you have to make it big, or you have to make it braille, or you have to make it italics.

[02:42:13] Speaker 01:
suddenly makes it the same as that one that had the big Heliox label.

[02:42:16] Speaker 01:
They're just not.

[02:42:18] Speaker 01:
They're different words.

[02:42:19] Speaker 01:
They're different words that perform entirely different functions under the statutory scheme, communicate entirely different information.

[02:42:28] Speaker 01:
That doesn't seem to me a difficult question.

[02:42:31] Speaker 01:
You wanted to just define, I'm just saying they want a completely different word.

[02:42:36] Speaker 01:
One's an active ingredient.

[02:42:38] Speaker 01:
One's a name brand.

[02:42:39] Speaker 01:
Totally different things for health reasons.

[02:42:43] Speaker 01:
They want that.

[02:42:44] Speaker 01:
That seems to me not a difficult, that's not the same answer.

[02:42:49] Speaker 01:
And you don't have to go running around looking for an exception to talking to a wrong buyer because they are a manufacturer, right?

[02:42:55] Speaker 01:
And then you grapple with the 20MG issue, but it just, I mean,

[02:43:01] Speaker 01:
I agree that those are not the same word.

[02:43:08] Speaker 00:
I agree that those are not the same word.

[02:43:16] Speaker 00:
I agree that they're not.

[02:43:17] Speaker 01:
Not a name they can lawfully use, not just for FDA reasons, but for intellectual property reasons.

[02:43:22] Speaker 00:
Yes, I agree.

[02:43:24] Speaker 00:
I'm not fighting that at all.

[02:43:27] Speaker 01:
But I do want to say it'll be so hard to do it under shame.

[02:43:30] Speaker 01:
Some things may be, but I mean, you know.

[02:43:34] Speaker 00:
I think that's my point, is actually just, and I apologize for not answering the question really.

[02:43:39] Speaker 00:
Yes, those are not the same.

[02:43:41] Speaker 00:
I think the next point I was trying to make was that I think the sameness requirement

[02:43:48] Speaker 00:
We understand, FDA understands same to mean same, identical, and it understands that there are permissible changes.

[02:43:54] Speaker 00:
Everyone agrees there are permissible changes.

[02:43:55] Speaker 00:
I think the question is, how do you understand those permissible changes to fit within the statutory scheme?

[02:43:59] Speaker 00:
And my point was just simply that there might be very hard questions if the analysis is that all those fit into the sameness element.

[02:44:06] Speaker 00:
That was my point.

[02:44:07] Speaker 01:
Thank you.

[02:44:08] Speaker 01:
Any more questions?

[02:44:10] Speaker 00:
There's nothing else.

[02:44:11] Speaker 01:
Sorry, we are well into lunchtime.

[02:44:13] Speaker 01:
I'm sure you're all getting hangry with us, but we have to have a chance here.

[02:44:18] Speaker 01:
You should provide snacks.

[02:44:20] Speaker 05:
Thank you, your honor.

[02:44:20] Speaker 05:
Good afternoon.

[02:44:21] Speaker 05:
I was wishing I had a bigger breakfast.

[02:44:23] Speaker 05:
I know we've been here for a while, so I'll try not to.

[02:44:25] Speaker 01:
I'm sorry.

[02:44:25] Speaker 01:
It's just really hard.

[02:44:26] Speaker 01:
It's a really hard case.

[02:44:27] Speaker 05:
No, absolutely.

[02:44:28] Speaker 05:
So I'll try not to be repetitive, but it is an important case to have in the generics industry.

[02:44:32] Speaker 05:
So there are some points I wanted to hit.

[02:44:33] Speaker 05:
First, on the statutory question and required, Judge Millett and I believe Judge Pan asked a few times for a case.

[02:44:39] Speaker 05:
I have one.

[02:44:40] Speaker 05:
It's one we didn't cite in the briefs, but I do think it endorses our understanding of required because to be consistent with appropriate.

[02:44:49] Speaker 05:
It's a Supreme Court case, National Railroad Passenger Corp.

[02:44:53] Speaker 05:
versus Boston Marine Corp.

[02:44:55] Speaker 05:
503 U.S.

[02:44:56] Speaker 05:
407, 1992.

[02:44:58] Speaker 05:
In candor, it's... Is there a pin site?

[02:45:04] Speaker 05:
I don't have a pin site, but I think it's the holding of the case as to whether... 503 U.S.

[02:45:09] Speaker 02:
407.

[02:45:11] Speaker 05:
Whether the International Commerce Commission

[02:45:14] Speaker 05:
reasonably interpreted the provision that had required to mean appropriate in candor.

[02:45:20] Speaker 05:
It was a Chevron case from an earlier time, but I think the same analysis from that time.

[02:45:28] Speaker 05:
No, absolutely.

[02:45:30] Speaker 05:
But it's the same analysis that we are engaging in and the FDA is that

[02:45:33] Speaker 05:
there are a range of potential meanings for a required because maybe you think the more natural one is necessitated by is more of a strict logical requirement but in certain contexts it can be consistent with appropriate for the circumstances the court appropriate for the circumstances here would be

[02:45:51] Speaker 05:
I think the way I look at it here in terms of what a limiting principle is, I don't know that it needs to resolve every case for all time, but as Judge Chutkin noted in her opinion, this is a very narrow issue because we're dealing with a formatting distinction rather than a content one.

[02:46:10] Speaker 02:
But it isn't a narrow issue.

[02:46:12] Speaker 02:
We wouldn't be spending that much time

[02:46:14] Speaker 05:
It's an interesting statutory puzzle.

[02:46:17] Speaker 05:
I agree with that.

[02:46:18] Speaker 05:
But my point is that the distinction between format and content, I think, does a fair amount of work.

[02:46:24] Speaker 05:
And that the court, as a general matter, can understand that it is appropriate for manufacturers to have discretion about marketing decisions about formatting.

[02:46:32] Speaker 05:
Those kinds of decisions and deviations in no way conflict with the general structure of Hatch-Waxman and what Congress intended, which was that

[02:46:40] Speaker 05:
as Judge Rogers was noting, and does piggyback on the previous brand approval.

[02:46:46] Speaker 02:
It's going to take us 12 years to get an answer.

[02:46:50] Speaker 02:
Teva is on the market.

[02:46:52] Speaker 03:
That's right.

[02:46:53] Speaker 02:
All right.

[02:46:53] Speaker 02:
So you don't care.

[02:46:54] Speaker 02:
All right.

[02:46:56] Speaker 02:
But for the normal case that we see, the generic is not on the market.

[02:47:02] Speaker 02:
All right.

[02:47:02] Speaker 02:
So they're very interested in time and getting their application through

[02:47:11] Speaker 02:
and their drug out there, all right?

[02:47:15] Speaker 02:
So when Congress says same, why don't we just say same, all right?

[02:47:22] Speaker 02:
And move on, all right?

[02:47:25] Speaker 02:
As opposed to spending all this time trying to figure out, either we figure out or as Judge Pan says, she didn't say it, but she's in a question, we send it back and let the agency

[02:47:38] Speaker 02:
figure this out and give us some more findings of fact and then it can come back up here, you know, go back and forth for generations.

[02:47:48] Speaker 02:
So, Hacks, Hacks-Watson was trying to cut through all this.

[02:47:54] Speaker 02:
So, samey say.

[02:47:56] Speaker 02:
But, obviously, you're not going to put misrepresentations on the generic slave.

[02:48:05] Speaker 02:
So you're going to take those changes out.

[02:48:10] Speaker 02:
All right?

[02:48:11] Speaker 02:
Sure.

[02:48:12] Speaker 02:
And, you know, what's the limit?

[02:48:17] Speaker 02:
And now we hear from Vanda that, well, it's a pretty wishy washy term.

[02:48:23] Speaker 02:
All right, because you can do de minimis and there's some other things.

[02:48:28] Speaker 02:
And once we go down that road, I don't know where we stop.

[02:48:33] Speaker 02:
And I think that's what our questions have been trying to elucidate for us from lawyers who are, I'll just say for myself, more familiar with this field, not only in terms of appellate law, but at the agency, with the agency proceedings as well.

[02:48:56] Speaker 05:
Sure, a couple responses to that.

[02:48:58] Speaker 05:
I mean, streamlining the process is very important to have as well.

[02:49:01] Speaker 05:
It's the biggest generic manufacturer in the world.

[02:49:04] Speaker 05:
I don't think if you took the idea that it means identical sameness, which I think I understand your honor's question to be postulating.

[02:49:11] Speaker 02:
It said where it would be obviously misleading.

[02:49:14] Speaker ?:
Right.

[02:49:14] Speaker 05:
except where it would be obviously misleading.

[02:49:15] Speaker 05:
I don't think that's workable and I think Vanda agrees that's not workable.

[02:49:18] Speaker 05:
At a minimum you have the trade dress problem.

[02:49:21] Speaker 05:
Well, that's a big but because I don't understand how the FDA is in a position to differentiate when a change is required because of trade dress protection versus it's an optional formatting decision.

[02:49:35] Speaker 02:
What do you mean?

[02:49:36] Speaker 05:
I mean, something that would be protectable as intellectual property.

[02:49:39] Speaker 02:
I was using it in the same way, but I wanted to be sure.

[02:49:43] Speaker 05:
No, that's right.

[02:49:43] Speaker 05:
And I understood.

[02:49:44] Speaker 05:
I mean, Mr. Hughes.

[02:49:46] Speaker 02:
That's more difficult.

[02:49:47] Speaker 02:
I totally agree.

[02:49:48] Speaker 02:
But in our case, it's simple.

[02:49:50] Speaker 05:
I don't think that's right because, again, you're not.

[02:49:53] Speaker 02:
You don't have the same brand name, your drug.

[02:49:55] Speaker 02:
You haven't given it the same brand name.

[02:49:58] Speaker 02:
And the active ingredient is what you have to make clear to the public that this is just as good as Vanda's Hillel's because it has the same active ingredient.

[02:50:09] Speaker 05:
It has the same active ingredient and our label has all the same content.

[02:50:13] Speaker 05:
It has all the same efficacy.

[02:50:15] Speaker 02:
So what we're down to is putting braille on your label is going to cost your client more money?

[02:50:21] Speaker 05:
Yes, that's right.

[02:50:22] Speaker 02:
And so it'll cut into the generics profits.

[02:50:25] Speaker 05:
cut into the generic profits.

[02:50:27] Speaker 02:
Instead of having an 80% profit, it'll have a 78% profit.

[02:50:30] Speaker 05:
Generic profits do not look anything like that.

[02:50:33] Speaker 05:
No, but I think it's a relevant difference because brands do have a different interest in developing marketing features and trying to grow the market.

[02:50:43] Speaker 05:
Vanda, before there was generic entry, was charging $25,000 a month for a 30%

[02:50:48] Speaker 05:
the point of generics and the point of Hatch Waxman is to accelerate generic entry and for generics to do it as cheaply as they can.

[02:50:56] Speaker 05:
So Vanda, if it wants an optional feature that it thinks is going to be helpful or as the medical officer in this case indicated, it might have some reputational benefit for Vanda.

[02:51:06] Speaker 05:
We don't think they're precluded from doing that, but the question is whether generics have to adopt those optional formatting features under our duty of saneness.

[02:51:16] Speaker 02:
Can I ask?

[02:51:16] Speaker 02:
Can I just be clear though on your question?

[02:51:19] Speaker 02:
You're focusing on required, right?

[02:51:23] Speaker 02:
Not required.

[02:51:24] Speaker 05:
I'm sorry.

[02:51:25] Speaker 05:
I'm not sure I understand your question.

[02:51:27] Speaker 02:
I thought I just wanted to be clear before Judge Penn.

[02:51:30] Speaker 02:
Sure.

[02:51:31] Speaker 02:
Question.

[02:51:31] Speaker 02:
But maybe you want to go ahead.

[02:51:32] Speaker 05:
Well, I guess all I was saying is that by hypothesis, when we're dealing with the statutory question as opposed to the arbitrary capricious issue, we have a labeling feature that the agency has determined is not necessary for safety.

[02:51:45] Speaker 05:
And so the question is, and it's it's about format rather than the actual content that is being conveyed.

[02:51:52] Speaker 04:
So that was my question.

[02:51:53] Speaker 04:
OK, does your argument depend on it being a formatting issue?

[02:51:56] Speaker 04:
Because I see that

[02:51:58] Speaker 04:
Even if it's not necessary for safety, it can also be substantive.

[02:52:02] Speaker 04:
And I think I see it not as just a binary thing.

[02:52:05] Speaker 04:
Either it's necessary for safety or it's like font that there could be something in the middle, something substantive that they've included.

[02:52:12] Speaker 04:
And I feel like this is more substantive because they went through a whole approval process, etc.

[02:52:16] Speaker 04:
Does your position depend on it being just a formatting thing?

[02:52:19] Speaker 05:
I think the fact that it's formatting is an important distinction, and it's one the district court relied on heavily.

[02:52:24] Speaker 05:
I don't agree with the premise that because it went through an approval process and the agency engaged in it, that means it's more substantive.

[02:52:32] Speaker 05:
The agency does that with all sorts of formatting features of a label.

[02:52:35] Speaker 05:
It makes a determination that the label as a whole, whether it's the font, whether it's the color, whether it's the layout, is not going to be misleading.

[02:52:43] Speaker 05:
So I don't think that distinguishes

[02:52:45] Speaker 05:
and just a small factual point, but Your Honor was noting the commentary and the back and forth with Vanda regarding whether this had safety benefits.

[02:52:56] Speaker 05:
The agency was exploring that.

[02:52:57] Speaker 05:
I believe those statements to Vanda were made before the labeling study that it conducted.

[02:53:02] Speaker 05:
So I don't think it's correct to read the record as a whole is suggesting that the agency concluded there is an affirmative safety benefit from the inclusion of Braille.

[02:53:13] Speaker 05:
I think the study itself is revealing both the fact that it missed its lower bound.

[02:53:18] Speaker 05:
I'd invite the court to look at 1034 through 1036 of the Joint Appendix to see some of the commentary from actual participants in the study, many of whom both Braille readers and non-Braille readers found Vanda's label confusing, including the non-Braille readers.

[02:53:32] Speaker 05:
I wouldn't know what to do with this.

[02:53:34] Speaker 05:
braille readers thought it wasn't very clear or effective.

[02:53:37] Speaker 05:
So I just don't think that that is the predicate that the agency was relying on, that it made any type of finding in that regard.

[02:53:46] Speaker 05:
But I do think, so if we're bracketing the safety issue, which is dealt with through an arbitrary capricious challenge,

[02:53:52] Speaker 05:
We think obviously the agency gets more deference there and that it was well supported its decision in the citizen petition.

[02:53:58] Speaker 05:
We're dealing with something that is purely voluntary, that is not necessary to safety, the agency determined, is not going to the content of the label.

[02:54:08] Speaker 01:
Is there any finding that it promotes safety?

[02:54:11] Speaker 05:
No, that's the point.

[02:54:12] Speaker 05:
I don't think there is any such finding.

[02:54:15] Speaker 05:
And Mr. Hughes was using the PLEVA fencing example.

[02:54:19] Speaker 05:
I think that's just fundamentally different because the issue there is that if you're adding warnings about the way this drug works, it creates the impression that these are not therapeutically equivalent, which completely- Oh, PLEVA, but PLEVA's about, and this is why I just, I'm confused as to-

[02:54:36] Speaker 01:
I'm confused about how these cases are applying here because leave us essentially that generic, you don't get to change the label in ways that are going to make it more safe.

[02:54:47] Speaker 01:
Then such a name rent.

[02:54:49] Speaker 05:
That's right.

[02:54:50] Speaker 05:
But again, it was about the right.

[02:54:53] Speaker 01:
And it seems to me.

[02:54:56] Speaker 01:
there's an argument that requiring the active ingredient to be presented a particular way that's different from the way it's in a more accessible or easily viewed or understandable way than it is on the name brand would be a plain problem.

[02:55:22] Speaker 05:
I think it might be under Vanda's view of safety.

[02:55:25] Speaker 05:
If they actually think that the Braille is essential to safety and that it's adding something, I can see the issue with the MSN label and how that problem arises.

[02:55:34] Speaker 05:
But given the agency's determination that it is not essential for safety, that is, I think, effectively neutral, then I don't think it fits into the PLEVA demencing issue.

[02:55:44] Speaker 05:
And again, I think the problem in PLEVA and the reason that the FDA and the court- But if it were-

[02:55:51] Speaker 01:
Promoting safety will be a pliva problem.

[02:55:55] Speaker 01:
It's not promoting safety.

[02:55:56] Speaker 01:
It's a style problem.

[02:55:57] Speaker 01:
It's just a style choice.

[02:55:59] Speaker 05:
I think it's a style choice.

[02:56:00] Speaker 05:
Whether it would necessarily be a pliva problem, I do think it's a different issue.

[02:56:03] Speaker 05:
Here the agency concluded is essentially neutral.

[02:56:06] Speaker 05:
It's like a style choice.

[02:56:09] Speaker 04:
It's the kind of thing that manufacturers... It's not a choice that's required because you're a different manufacturer.

[02:56:14] Speaker 05:
If you disagree with me, Judge Pan, about the right meaning of required by in this context, then I do think we're reading required by to be appropriate to, you know, consistent with rather than being a logical necessity.

[02:56:29] Speaker 05:
As government counsel, I think, was trying to illustrate, FANDA doesn't actually take its logically necessary reading consistently either.

[02:56:38] Speaker 05:
There was talk about the Seneca case.

[02:56:39] Speaker 05:
I understand the court thinks that way.

[02:56:40] Speaker 04:
But you agree that it's not required because you're a different manufacturer, because MSN was able to do it even though they were different manufacturers.

[02:56:46] Speaker 05:
I do not agree with that, but it's because I think I have a different understanding of what required means than the one on honor issues.

[02:56:52] Speaker 04:
Do you agree that it's not required?

[02:56:54] Speaker 05:
It is not logically, it's not unavoidable.

[02:56:57] Speaker 05:
It's not unavoidable if that's what the right meaning of required is.

[02:57:01] Speaker 05:
We just think that's not the right meaning of required.

[02:57:03] Speaker 04:
No, I understand that.

[02:57:04] Speaker 04:
But if required means necessary, then you agree that this is not required because you're a different manufacturer.

[02:57:09] Speaker 05:
If required means inevitable, yes.

[02:57:12] Speaker 05:
I agree with that, but I don't think that that is correct.

[02:57:15] Speaker 05:
But I think there are structural reasons.

[02:57:17] Speaker 05:
We talked about the formulation issue.

[02:57:19] Speaker 05:
I didn't hear any discussion before of the Bristol-Myers case in which generic manufacturers make different decisions about whether to seek approval for a particular

[02:57:28] Speaker 05:
education because they need to avoid a patent or an exclusivity or that that's not something that has to do with how the drug is made.

[02:57:35] Speaker 05:
It's an optional decision.

[02:57:37] Speaker 05:
There are different ways in which the generic could just decide to get on the market rather than pursuing the carve out.

[02:57:43] Speaker 05:
So I think if you were going to follow is it because

[02:57:46] Speaker 05:
truly non-optional, that's contrary to Bristol Myers.

[02:57:51] Speaker 05:
And so I don't think that that can be a way to read the statute.

[02:57:55] Speaker 05:
And required because needs to mean the same thing in all these different examples.

[02:58:00] Speaker 05:
And to try to create ad hoc exceptions, I don't think works.

[02:58:05] Speaker 05:
I wanted to, I guess, a few other points.

[02:58:10] Speaker 05:
On the question about we were talking before about the importance of being streamlined and the risk of if these voluntary formatting features became mandatory for the generic and not the brand that could raise costs and deter generic entry and

[02:58:26] Speaker 05:
I think the suggestion was, well, maybe a way that the agency could deal with that is by not approving those features in the first place.

[02:58:33] Speaker 05:
I agree with what I understood to be government counsel's presentation, that that's not an option that's open to the FDA.

[02:58:40] Speaker 05:
The relevant statutory provisions are shall approve unless certain conditions are not satisfied.

[02:58:46] Speaker 02:
So if... What is your understanding of that regulation?

[02:58:52] Speaker 02:
The label shall include 1, 2, 3, 4, 5.

[02:58:59] Speaker 05:
Unless, unless, yeah, they have to include certain things.

[02:59:03] Speaker 05:
There's a general backdrop that labels can't be misbranded.

[02:59:07] Speaker 05:
So they can't be misleading.

[02:59:08] Speaker 05:
They can't compromise safety.

[02:59:10] Speaker 05:
But if you have a feature that the agency has concluded, it's not necessary for safety.

[02:59:14] Speaker 05:
We're not, we don't even not even sure if it enhances safety, but it's something that the brand wants to do to build this brand.

[02:59:19] Speaker 05:
I mean, that's why it has the product name is the brand in the first place.

[02:59:23] Speaker 04:
It's engaged provision that says that.

[02:59:25] Speaker 05:
It's engaged to 355 D is the is the relevant provision for brands approval and then it uses a similar shall approve language in the context of and does I think it's Jay for.

[02:59:41] Speaker 05:
So I don't, and there's been discussion about, because I think Vanda's position, they want to preserve most of what the agency has already been doing, but move it into a different bucket because they recognize that it would be problematic to suggest that you

[02:59:56] Speaker 05:
can't have deviations in trade dress or font or other things.

[03:00:00] Speaker 05:
We think it fits best in the different manufacturer exception rather than similar.

[03:00:07] Speaker 05:
But we do think it is very important that these voluntary formatting features not be considered something that generic manufacturers are obliged to adopt.

[03:00:15] Speaker 05:
So whichever, it's not all.

[03:00:18] Speaker 05:
We think the agency is right.

[03:00:19] Speaker 05:
We obviously care very much about this case.

[03:00:21] Speaker 05:
But I think that's the important takeaway that that would be really detrimental to the generics.

[03:00:25] Speaker 02:
I mean, I'm clear in my own mind why the agency is relying so heavily on that, but do you think that's what Congress had in mind?

[03:00:32] Speaker 05:
I do.

[03:00:33] Speaker 05:
I think what Congress had in mind and what the structure is, is that ANDAs are about therapeutic equivalents and being able to piggyback on the brand, as you're on a reference before.

[03:00:45] Speaker 02:
That's what we, Congress, want the agency to focus on.

[03:00:48] Speaker 05:
That's what we want the agency to focus on.

[03:00:49] Speaker 02:
End of discussion.

[03:00:50] Speaker 02:
And so when we write a statute, that's when we enact a statute that says identical, same, we don't really mean it.

[03:01:01] Speaker 02:
We mean within the discretion of the agency.

[03:01:06] Speaker 05:
No.

[03:01:06] Speaker 05:
I mean, I think the concept of what is same is whether that's like literal identity or that there's some room around the edges.

[03:01:13] Speaker 05:
But I don't think it was necessarily a broad deli.

[03:01:15] Speaker 02:
I think our questioning has indicated some

[03:01:20] Speaker 02:
agreement, I think, about the fact that same is not identical.

[03:01:25] Speaker 02:
I mean, you have to change the brand name.

[03:01:29] Speaker 02:
Right.

[03:01:30] Speaker 02:
Et cetera.

[03:01:32] Speaker 02:
But how much further you go is the required by.

[03:01:37] Speaker 05:
Well, sure.

[03:01:38] Speaker 05:
I mean, I think the fact that the language is required because a different manufacturer is what's used to change the manufacturer name suggests that maybe, you know, same does do some some real work.

[03:01:50] Speaker 05:
And it's a little at least to me a little bit unnatural to put in all the different trade dress protections, for example, into the same this bucket with labels that obviously look quite different.

[03:02:03] Speaker 05:
But to say that they are they are the same.

[03:02:05] Speaker 05:
But nonetheless, I

[03:02:06] Speaker 05:
I think, again, my point is that what is important for the generics industry and for the proper functioning of this statute is that voluntary formatting features adopted by brands that are not supported by safety considerations not be something that a generic necessarily has to follow and adopt.

[03:02:26] Speaker 02:
Under that interpretation, would it require the agency then to have a formal finding in the record that

[03:02:36] Speaker 02:
For example, braille is not necessary.

[03:02:43] Speaker 05:
Well, I think that's present here, that they made that determination, that braille.

[03:02:47] Speaker 02:
You find it in that succinct way.

[03:02:52] Speaker 05:
Well, I mean, it's certainly found in a succinct way in the citizen petition, if you're talking about the contemporaries.

[03:02:56] Speaker 02:
I found it in terms of how braille came to be.

[03:03:00] Speaker 02:
But as Judge Pan's questions,

[03:03:04] Speaker 02:
highlighted, the agency was considering safety in terms of Braille.

[03:03:10] Speaker 02:
My reading of the agency's answers, it said it didn't answer that question.

[03:03:16] Speaker 02:
It turned it around, turned it inside out.

[03:03:19] Speaker 02:
It said, well, it doesn't hurt anything.

[03:03:22] Speaker 02:
Okay.

[03:03:24] Speaker 05:
Well, I think that's right, and I think that's because that's all Vanda's study was designed to establish.

[03:03:28] Speaker 05:
Vanda was asked by the agency.

[03:03:30] Speaker 02:
So if it doesn't hurt anything, why shouldn't the generic be required to do it?

[03:03:37] Speaker 05:
Because it has not been demonstrated to have any safety benefit and because it's costly.

[03:03:42] Speaker 02:
Well, that's why I say, doesn't the agency have to make a finding?

[03:03:45] Speaker 02:
So it's clear when these things are challenged that the agency has found this is not necessary for safety.

[03:03:53] Speaker 02:
and the effectiveness of the drug, that this is pure marketing, nothing more.

[03:04:05] Speaker 02:
It doesn't hurt anything, but it has nothing to do with the safety and efficacy of the drug.

[03:04:11] Speaker 02:
I mean, it would certainly make our life easier, and presumably it would speed these matters through faster for the generics.

[03:04:21] Speaker 05:
I guess I read the records for the agency here to have made such a finding.

[03:04:24] Speaker 05:
And to the extent there's ambiguity in the original approval, they certainly made that finding in the citizen petition.

[03:04:29] Speaker 05:
And I understood my friend, Mr. Hughes, to say they were recognizing.

[03:04:32] Speaker 01:
Is the FDA allowed to disapprove a label just because it promotes the name brand?

[03:04:38] Speaker 05:
No, I think that's our point.

[03:04:42] Speaker 05:
Right.

[03:04:42] Speaker 05:
There would be no basis for it to do so.

[03:04:45] Speaker 05:
I don't understand that quite.

[03:04:50] Speaker 02:
Unless the answer is illegal.

[03:04:54] Speaker 02:
That has no authority.

[03:04:56] Speaker 05:
Well, I think that's no, I think that's right.

[03:04:58] Speaker 05:
Because the way that the set framework works.

[03:05:02] Speaker 05:
Yes, right.

[03:05:03] Speaker 05:
They have no authority to decide things are these are superfluous.

[03:05:07] Speaker 05:
They don't harm safety and efficacy, but we don't want.

[03:05:10] Speaker 05:
the generic to have to go ahead and do the expense of doing unnecessary things, whether it's braille, whether it's a hologram.

[03:05:17] Speaker 05:
Because the way the statute is structured is generics, as your honor was noting, Judge Rogers, it's supposed to be streamlined approval to get lower cost generics on the market faster.

[03:05:27] Speaker 05:
And so brands have an interest, potentially, in having broader marketing features.

[03:05:33] Speaker 05:
If you go to any sporting event in Washington, DC, you'll see Vanda posters all over the place.

[03:05:38] Speaker 05:
That's not how the generic market

[03:05:40] Speaker 02:
I noticed that for the first time this season.

[03:05:42] Speaker 02:
That's right.

[03:05:45] Speaker 05:
I pointed out to my son at Capitals games a few times.

[03:05:48] Speaker 05:
But there's nothing wrong with that.

[03:05:50] Speaker 05:
Brands have different, they operate differently.

[03:05:53] Speaker 05:
But the notion is that generics should not be required to copy those formatting features, those things that are done from a marketing perspective.

[03:06:02] Speaker 05:
I wanted to address what I think were Judge Mollett's questions about what strikes me as the inconsistency in Vanda's position that it says we're relying on sameness to force you to make a change, that you should change the active ingredient to have that in Braille.

[03:06:20] Speaker 05:
I think that underscores why their understanding is not

[03:06:24] Speaker 05:
a proper reading of the statute.

[03:06:26] Speaker 05:
And I think there's also a reason why they're not really relying on the 20 milligrams because it would make no sense at all.

[03:06:31] Speaker 05:
This is a product that's approved in a single strength.

[03:06:34] Speaker 05:
So the notion of having Braille for the strength that is the only strength that

[03:06:39] Speaker 05:
that doesn't make a lot of sense.

[03:06:40] Speaker 05:
So they have to bend over backwards to suggest, well, you need to sort of transpose and now have the active ingredient be in Braille rather than the brand name for the product.

[03:06:52] Speaker 05:
Maybe that's a sensible policy result.

[03:06:54] Speaker 05:
And we don't disagree with the approval of MSN's label necessarily.

[03:06:58] Speaker 05:
But I don't see how that comes from a duty of sameness.

[03:07:02] Speaker 05:
And one good indication that it doesn't and that goes to the sort of piggybacking streamline point before is that when MSN

[03:07:08] Speaker 05:
did that, they had to go get their own certificate of translation, because it's not the same word.

[03:07:14] Speaker 05:
The Braille looks different.

[03:07:18] Speaker 05:
They had to make sure that this Braille was going to be effective.

[03:07:22] Speaker 05:
And so it's not something that is the same.

[03:07:25] Speaker 05:
I don't believe so.

[03:07:28] Speaker 05:
I apologize if I'm misstating, but I don't believe so.

[03:07:30] Speaker 05:
The agency did very clearly require a certificate of translation as to the active ingredient, because it hadn't previously been in Braille.

[03:07:38] Speaker 05:
active ingredient appears on both labels.

[03:07:40] Speaker 05:
It's required to be on the brand label.

[03:07:43] Speaker 05:
It's required to be on a generic label.

[03:07:45] Speaker 05:
Generics, by the way, can adopt their own brand name.

[03:07:47] Speaker 05:
It's not common, but it's something that drugs approved through the ANDA pathway are permitted to do.

[03:07:54] Speaker 05:
And so again, it's not, if the test is logical necessity that Vanda seems to presuppose, it clearly is not logically necessary that Teva or any of these other generic products have converted tazamaltium into

[03:08:08] Speaker 05:
braille.

[03:08:10] Speaker 05:
I wanted to make just one last comment about remedy and then if the court has any questions as we noted in our brief we and the government argued below that to the extent there was a concern about the agency's decision they thought it wasn't well supported that we didn't think there should be vacatur given that the significant disruption to the market.

[03:08:28] Speaker 05:
It's been two years since then the disruption would be even greater so obviously we think the court should affirm but to the extent the court has

[03:08:35] Speaker 05:
It disagrees with the agency's interpretation, including because it thinks maybe it belongs in a different textual bucket than the agency relied upon.

[03:08:44] Speaker 05:
We think that's all the stronger indication that the question of remedy should be reserved to the district court, which can decide whether the proper remedy is vacatur or not.

[03:08:53] Speaker 05:
We raised that in our brief.

[03:08:55] Speaker 05:
FANDA didn't address that in its reply, so I think it's really forfeited.

[03:08:58] Speaker 05:
But in any event, we think to the extent the court identifies any issue, it should make clear that the remedy question is open to the district court on remand.

[03:09:05] Speaker 04:
Just thinking about the vacature issue.

[03:09:09] Speaker 04:
The normal remedy is vacature.

[03:09:13] Speaker 05:
It's the default remedy, but it's also something that's subject to the district court's discretion and reviewed by this court for abuse of discretion only.

[03:09:20] Speaker 04:
It would have to be if we interpreted the statute to mean it has to be required and braille is not required because you're a different man.

[03:09:30] Speaker 04:
Removing the braille would not be required.

[03:09:33] Speaker 04:
doesn't fit within that, then why wouldn't we vacate?

[03:09:36] Speaker 04:
Because I don't see that additional explanation.

[03:09:39] Speaker 05:
This was briefed by us in the government and we'll record and we asked for supplemental briefing there to the extent it would become relevant.

[03:09:46] Speaker 05:
Is it an easy process to make a label change?

[03:09:50] Speaker 05:
There are ways to do it.

[03:09:51] Speaker 05:
We think we ought not to be required to do it.

[03:09:53] Speaker 05:
It would impose costs.

[03:09:54] Speaker 04:
We would not vacate your whole approval.

[03:09:55] Speaker 05:
Right, that's exactly right.

[03:09:57] Speaker 05:
Again, let's be real about what was happening here.

[03:10:00] Speaker 05:
Vanda was seeking to kick us off the market.

[03:10:03] Speaker 05:
They say it's a safety issue, but that's not, from our perspective, what this was about.

[03:10:07] Speaker 05:
So that is our submission.

[03:10:09] Speaker 01:
OK, thank you.

[03:10:10] Speaker 05:
If the court has no further questions.

[03:10:13] Speaker 01:
Thank you very much, Johnson.

[03:10:15] Speaker 01:
OK, Mr. Hughes, you can take us home now.

[03:10:18] Speaker 01:
We'll give you five minutes.

[03:10:22] Speaker 06:
Thank you, your honor.

[03:10:23] Speaker 01:
I'm afraid that there'd be no purpose, this identifying thing would, there'd be no purpose to having just the 20 mg in Braille.

[03:10:31] Speaker 06:
There'd absolutely be a purpose of having the 20 mg because it tells you both the dose, but it also tells you this is the product.

[03:10:37] Speaker 01:
Only one dose for this product.

[03:10:38] Speaker 06:
But it tells you that this is the only bottle in your medicine cabinet that is going to have Braille on it.

[03:10:42] Speaker 06:
So it tells you, you would have this tactile sensation.

[03:10:45] Speaker 06:
And that's why the FDA approved this, even though, as noted, not all blind people read Braille.

[03:10:55] Speaker 01:
I bet there's other tactile ways that those who are blind are able to differentiate.

[03:11:02] Speaker 01:
objects.

[03:11:03] Speaker 01:
This is one and Vanda's studies show that 100 one way of tact highly distinguish in a different shape bottle different place keep it on the shelf.

[03:11:10] Speaker 06:
The FDA said this is one way to do it.

[03:11:13] Speaker 06:
And that's why we had a study that included people who don't even read Braille.

[03:11:17] Speaker 06:
They could still be able to distinguish as a tactile feature.

[03:11:20] Speaker 06:
But I think the critical thing here is my friends can't get away from the fact that they don't want the word required to mean required.

[03:11:26] Speaker 06:
They want the word required to mean optional.

[03:11:28] Speaker 06:
It's a real statutory problem for them that they can't deal with what the word required means.

[03:11:34] Speaker 06:
There has to be something.

[03:11:36] Speaker 01:
They deal with it.

[03:11:37] Speaker 01:
They offer a different interpretation than you do.

[03:11:39] Speaker 01:
that way you don't want same you you agree same doesn't mean same

[03:11:44] Speaker 06:
Your honor, they deal with it by giving the antonym of required by saying it should just be read to say optional.

[03:11:49] Speaker 06:
So basically, the problem with that is it strips the principle rule, the sameness requirement of any meaning.

[03:11:56] Speaker 06:
Our point is the way you understand all of this is, yeah, there are all sorts of different choices that generics can make.

[03:12:01] Speaker 06:
They can make choices about inactive products, about which indications to apply for, and those permissible choices that Congress has allowed will require labeling changes, as the court pointed out.

[03:12:12] Speaker 01:
The case that was mentioned,

[03:12:14] Speaker 01:
If I'd have a Supreme Court said, maybe they're doing things backwards.

[03:12:22] Speaker 01:
We think that as a matter of definition interpretation in the context of this statute, it is plausible, if not preferable, so this is not just a shipwreck, if not preferable to say that Amtrak can find that an acquisition is required when it is a useful and appropriate way to accomplish its goals.

[03:12:40] Speaker 06:
This brief, this case wasn't in their brief, so I've not read the case.

[03:12:43] Speaker 06:
I can't really reasonably respond without having read the case that they pointed us to.

[03:12:49] Speaker 01:
That's a fair point.

[03:12:50] Speaker 01:
I just want to say when you sort of say it's the opposite, which I sort of did too.

[03:12:55] Speaker 01:
And then here I have the Supreme Court saying that this is actually an accepted in a different case.

[03:12:59] Speaker 06:
You're happy to look at it, but it sounds like this was under the not a lot of right framework.

[03:13:07] Speaker 01:
It's not preferable.

[03:13:08] Speaker 01:
It was interesting.

[03:13:09] Speaker 01:
Just say it's possible.

[03:13:10] Speaker 01:
I said, if not preferable under the context, I think that's what we have to think about.

[03:13:14] Speaker 06:
My friends, though, they need required to mean optional because our point is, yes, there are all sorts of changes outside.

[03:13:21] Speaker 06:
So the principle thing is the label has to be the same.

[03:13:23] Speaker 06:
And we know Congress, though, left generics to make different choices about their products.

[03:13:27] Speaker 06:
When they make one of those permissible changes, there will be times where they are required then to change their label for their label to be accurate.

[03:13:35] Speaker 06:
That's what the exception does.

[03:13:37] Speaker 06:
It does not, that exception would swallow the rule.

[03:13:40] Speaker 06:
if they can simply make any change they want so long as FDA otherwise approves it and doesn't find that change to be misleading.

[03:13:47] Speaker 06:
The exception would literally quite literally swallow the rule at that point.

[03:13:51] Speaker 06:
They have to be able to point to some change that they are making external to the principal rule that the label needs to be the same for the word required to do any work and not mean it's antonym of optional.

[03:14:05] Speaker 06:
On the sameness point, I just want to say if I'm wrong about the sameness point, I don't think I am.

[03:14:09] Speaker 06:
I think as we discussed, sameness doesn't necessarily mean photographic copy.

[03:14:14] Speaker 06:
If I'm wrong about that, though, it points the opposite direction.

[03:14:17] Speaker 06:
It just means FDA has been too flexible in allowing some of the small changes.

[03:14:21] Speaker 06:
We haven't disagreed with that.

[03:14:22] Speaker 06:
That is how FDA has approached this.

[03:14:24] Speaker 06:
But that's where I think it resides as a textual matter in the statutory text for sameness.

[03:14:30] Speaker 06:
But again, if my colleagues are correct, then I'm wrong.

[03:14:34] Speaker 06:
If I'm wrong about what same means, the result is not that you stuff it into the exception where it doesn't work textually.

[03:14:41] Speaker 06:
It means that labels should look more alike for the reasons that Judge Rogers has been suggesting, because this is what Congress wanted.

[03:14:48] Speaker 06:
Congress wanted an abbreviated process where not much has changed.

[03:14:51] Speaker 06:
FDA is not making a decision.

[03:14:53] Speaker 01:
But they also wanted one where the name brand couldn't adopt elements and components of the label that would make it more expensive than

[03:15:03] Speaker 01:
is required at all for safety and efficacy just to be able to live.

[03:15:07] Speaker 01:
Well, in terms of the expense, I mean, special bottle shape or whatever.

[03:15:10] Speaker 06:
I mean, it's my friend's last comment.

[03:15:13] Speaker 06:
There is kind of a what are we doing here question in terms of what we're talking about is a sticker that they could put on the bottle and why Teva has resisted putting a sticker that another generic has, I think.

[03:15:23] Speaker 01:
Is it going to cost more money?

[03:15:26] Speaker 01:
Does it cost more money?

[03:15:27] Speaker 06:
I mean, a center bottle, if that, to have a sticker on it?

[03:15:30] Speaker 01:
It would cost more money.

[03:15:31] Speaker 06:
There'll be a minuscule cost.

[03:15:33] Speaker 06:
And they have not drastically reduced the price of the product at all.

[03:15:36] Speaker 06:
So I think the margin is pretty significant.

[03:15:38] Speaker 06:
But we're not talking a significant cost factor here in any way for a clear sticker.

[03:15:42] Speaker 01:
Cost factor, and then you could do another thing over here.

[03:15:45] Speaker 01:
So you've got to repeat this style mark we did over here.

[03:15:48] Speaker 01:
You've got to have this QR code.

[03:15:49] Speaker 01:
You've got this hologram.

[03:15:50] Speaker 01:
And all of a sudden, it's more expensive for him.

[03:15:52] Speaker 06:
Well, what their obligation is for to be the same.

[03:15:55] Speaker 06:
And this takes me to the next point, which is FDA absolutely bleases the label.

[03:15:59] Speaker 06:
This notion that the pioneer can just stuff all these things onto the label and FDA is powerless to stop it is just flatly wrong.

[03:16:07] Speaker 01:
They didn't say that at all.

[03:16:09] Speaker 01:
What they said is once you've met all the statutory criteria and then you show us something,

[03:16:16] Speaker 01:
Here it was Braille, it could be something else somewhere else.

[03:16:19] Speaker 01:
And through studies and stuff, we've determined that that addition does not detract from, doesn't violate any statute or regulation, doesn't detract from safety and efficacy.

[03:16:34] Speaker 01:
What basis, does it misbrand it?

[03:16:36] Speaker 01:
What basis do they have to say, but you can't do it anyhow?

[03:16:39] Speaker 01:
That's exactly what FDA says, and this is- What basis, what section says they can, we just don't like flowers on labels?

[03:16:47] Speaker 06:
Senator, let me give an example from this drug that we've handled, which is that the company has studies that demonstrate the efficacy of next-day driving for patients who have taken this product and want to publish, which is- I'm asking you a very different question.

[03:17:01] Speaker 01:
You said they have statutory authority

[03:17:04] Speaker 01:
To if you wanted some flowers on there.

[03:17:07] Speaker 01:
And it didn't obscure anything.

[03:17:10] Speaker 01:
It didn't suggest any change in meaning.

[03:17:13] Speaker 01:
You met every label requirement that there is and you added flowers and they said, we think flowers.

[03:17:22] Speaker 01:
are ugly and inappropriate on medicine labels, do they have any, that's their view, do they have any statutory authority?

[03:17:30] Speaker 01:
And if so, tell me what statutory citation.

[03:17:34] Speaker 06:
Your honor, this is what- To say no.

[03:17:37] Speaker 06:
They do.

[03:17:37] Speaker 06:
They do this all the time in controlling the label.

[03:17:40] Speaker 06:
They will say- Under what statutory provision?

[03:17:43] Speaker 06:
I don't have the 355.

[03:17:45] Speaker 01:
I can submit a 28-J letter, but they will say- They can say keep your trademark off.

[03:17:50] Speaker 06:
Your honor, if you want, I promise you we will do this.

[03:17:52] Speaker 06:
We can hold this case in abeyance and we will petition the FDA to add flowers to our label, a QR code to our label, and let's see if they approve it because I'm sure they won't.

[03:18:01] Speaker 01:
We can hold this in abeyance.

[03:18:02] Speaker 01:
Well, I'm just telling you, they don't do it.

[03:18:05] Speaker 06:
And the proof is in the pudding here because what I'm saying is with this drug, we went to them and said, we have these study results that are interesting that doctors may want to know about that show what the effects are on next day driving of patients who have taken this particular sleep drug.

[03:18:20] Speaker 06:
We want to put them on the label.

[03:18:21] Speaker 06:
And FDA said, no, you're not allowed to put them on the label.

[03:18:25] Speaker 06:
That is them very

[03:18:26] Speaker 01:
That's a much more complicated question where they might have questions about your studies, just as they did here.

[03:18:32] Speaker 01:
That's totally different.

[03:18:33] Speaker 01:
If you just have a design change, your design, I'm talking about initial approval, and we want to use this font, and it doesn't complicate anything, doesn't obscure anything.

[03:18:46] Speaker 01:
They say, no, we prefer blue rather than red, and not for any ability of consumers to read the information.

[03:18:54] Speaker 01:
And your position is they get to dictate everything?

[03:18:58] Speaker 06:
The example your honor had asked is if we wanted to put on the label, generics are bad, they will tell us we can't put generics are bad.

[03:19:06] Speaker 01:
They are.

[03:19:06] Speaker 01:
They're going to say that.

[03:19:07] Speaker 01:
I'm sure FDA is not going to say if they, again, again,

[03:19:14] Speaker 01:
It sounds like you don't have a statutory site at this point.

[03:19:16] Speaker 01:
So, um, I'm just, it seems to me that they're, they have to improve, approve unless.

[03:19:25] Speaker 01:
The statute says you shall approve, you know, paraphrasing here, you shall approve unless.

[03:19:30] Speaker 06:
I've done this now with this company in labeling negotiations.

[03:19:36] Speaker 06:
The agency says, we don't like all of these things.

[03:19:38] Speaker 06:
We are redlining your label.

[03:19:40] Speaker 01:
We don't like them.

[03:19:41] Speaker 01:
I'm betting, and we just got to end this here, but I'm betting they don't say, we don't like it because we don't like flowers.

[03:19:47] Speaker 01:
They say it, we don't like it because we think it's distracting.

[03:19:50] Speaker 01:
We think it covers up X, Y, or Z. We think it confuses somebody.

[03:19:57] Speaker 06:
That may well be, but that goes to... That's very different.

[03:19:59] Speaker 01:
That goes to the statutory criteria.

[03:20:01] Speaker 01:
My question about flowers did not.

[03:20:03] Speaker 06:
I do not think that FDA is going to allow us to put flowers on the label.

[03:20:07] Speaker 06:
But if we put flowers on the label, Congress gave an answer which says the label needs to be the same to preclude FDA from having to do downstream work to figure out if there was something about the flowers that were a good idea or not a good idea.

[03:20:19] Speaker 06:
Again, I think that's not a real hypothetical because I don't think FDA will allow it.

[03:20:23] Speaker 06:
I don't think a manufacturer is going to put it on the label.

[03:20:25] Speaker 06:
But if they did, what the statute says is we're streamlining this.

[03:20:28] Speaker 06:
We're making it real easy for generics because all they have to do is copy what the brand name did.

[03:20:33] Speaker 06:
And again, I just don't think my friends can say what required means other than saying it's optional.

[03:20:39] Speaker 01:
Do my colleagues have any more questions?

[03:20:41] Speaker 01:
All right.

[03:20:42] Speaker 01:
Thanks.

[03:20:42] Speaker 01:
We've given everyone here a long time.

[03:20:43] Speaker 01:
We're really grateful for helping us with this challenging case, which is now submitted.