[00:00:29] Speaker 03:
Next case is Amerigen Pharmaceuticals versus UCB Pharma, 2017, 2596.

[00:00:39] Speaker 03:
Mr. Heyer.

[00:00:50] Speaker 01:
May it please the Court.

[00:00:51] Speaker 01:
I'd like to start off our presentation to talk about the issue of the standing and address that

[00:01:00] Speaker 01:
First, I think it's good to point out that there seems to be this erroneous assumption that a P3 patent certification on a and a product is permanent, that you can't change it.

[00:01:11] Speaker 01:
And that's just not the case.

[00:01:13] Speaker 01:
If this Court reverses the board and finds that the patent, the 650 patent, is invalid, then the FDA would be notified and would eventually have to change the listing of that patent and remove it from the Orange Book.

[00:01:30] Speaker 01:
At that point, Amerigen could change its P3 patent certification to a different certification, and the 650 patent would not prevent Amerigen from launching its ANDA product.

[00:01:43] Speaker 04:
If you could just describe that a little bit more.

[00:01:45] Speaker 04:
How automatic is it that under a circumstance like that, when a patent is delisted from the Orange Book, that someone like you that has a paragraph 3 certification could just walk in and

[00:01:58] Speaker 04:
very quickly, immediately, without any question from the FDA, get a modification of your certification?

[00:02:06] Speaker 01:
Well, it's not that easy, so I don't want to convey that.

[00:02:11] Speaker 04:
What other hurdles, what other issues would the FDA want to consider before they did anything to your paragraph 3 certification?

[00:02:18] Speaker 01:
By the regulations, you would need to show that the court has invalidated this patent

[00:02:24] Speaker 01:
And then the FDA would take that court decision and look to see if the patent provides any and a file or 180-day exclusivity.

[00:02:37] Speaker 01:
Once that 180-day exclusivity has passed, then the FDA would be permitted to delist that patent from the Orange Book.

[00:02:45] Speaker 03:
So it's not as simple as... But you still need an approved ANDA.

[00:02:52] Speaker 01:
Well, so Amerigen has

[00:02:54] Speaker 01:
an ANDA with a tentative approval.

[00:02:56] Speaker 01:
A tentative approval means the FDA has reviewed the ANDA, and but for the patents, it's technically able to be approved, and FDA would approve it.

[00:03:08] Speaker 01:
So the P3 is the barrier to a marriage and get an approval of this ANDA.

[00:03:16] Speaker 02:
I think that's the only barrier.

[00:03:19] Speaker 01:
Is that the only barrier?

[00:03:20] Speaker 01:
Yes, yes.

[00:03:21] Speaker 01:
There are four patents expiring in May of 2019 to which we have P3 certifications.

[00:03:27] Speaker 01:
Those would have to expire.

[00:03:29] Speaker 01:
We're not challenging those, but once those expire on May 11th, if you reverse the board's decision, we would be able to launch.

[00:03:38] Speaker 01:
We have patent challenges to later-expiring patents, 2028, I don't remember the dates, P4 certifications that have been maintained and continue on.

[00:03:49] Speaker 01:
Yes, the May 11th expiring patents and this P3.

[00:03:55] Speaker 03:
But on the merits of this.

[00:03:58] Speaker 01:
Okay.

[00:03:58] Speaker 03:
What is there to, in the, in the prior off, to motivate someone to take a metabolite and make these changes to, to, to make a prodrug, which is usually not active, to make a prodrug at a particular position

[00:04:21] Speaker 01:
Okay.

[00:04:23] Speaker 01:
So, Tolteridine is metabolized to 5-HMT.

[00:04:27] Speaker 01:
5-HMT is the active metabolite of Tolteridine.

[00:04:31] Speaker 01:
It is what provides the majority of the activity.

[00:04:35] Speaker 01:
You have prior references like Brine that, from 1998, that describe a difference in lipophilicity between Tolteridine and 5-HMT.

[00:04:46] Speaker 01:
Tolteridine was a billion plus a year drug.

[00:04:49] Speaker 01:
It worked well.

[00:04:50] Speaker 01:
So when you have a product that's the metabolite of it, but it has a tenfold less lipophilicity, I think one of Skill in the Art would want to try to be closer to lipophilicity of this successful drug that worked well.

[00:05:08] Speaker 03:
You also have... But what tells you, one Skill in the Art, to make a prodrug at that high hydroxy position and make an ester?

[00:05:20] Speaker 01:
versus making it a diaster, for example, are you asking?

[00:05:24] Speaker 03:
Yes, or making any other change.

[00:05:28] Speaker 03:
You've got a whole complicated molecule there.

[00:05:31] Speaker 01:
So there's really only three sites that you can modify, the amine and the two different hydroxy groups.

[00:05:39] Speaker 01:
One of the hydroxyl groups is the site, the five that has the activity.

[00:05:43] Speaker 01:
It's what is, when tolteridine is metabolized,

[00:05:47] Speaker 01:
It's where the changes occur.

[00:05:49] Speaker 01:
So you want to keep the five as the hydroxyl.

[00:05:52] Speaker 01:
The two, there's a number of reasons that we presented as to why you would want to modify the two.

[00:05:58] Speaker 01:
You want to avoid transesterification.

[00:06:00] Speaker 01:
So this is a site because of spheric hindrance.

[00:06:05] Speaker 01:
You don't want to overcomplicate the molecules.

[00:06:08] Speaker 01:
So if you make a diester, you're hoping that the esterases will cleave the esters from both the two and the five sites.

[00:06:19] Speaker 01:
If you just do one, it's more likely to occur.

[00:06:24] Speaker 01:
Why would you just do one also?

[00:06:25] Speaker 01:
So you're talking about a difference in lipophilicity, a tenfold difference.

[00:06:32] Speaker 01:
what I would call tweak, you're wanting to tweak the molecule bungard, which was, we've cited as a treatise on esters, talks about, well, it's a treatise on prodrugs, but it talks about esters, how they've been used, how simple they are, and how you can modify the lipophilicity easily with esters.

[00:06:52] Speaker 01:
So, then the question you might ask would be, why would you go to a short chain ester versus a long chain ester?

[00:06:59] Speaker 01:
Again, you're trying to tweak the lipophilicity.

[00:07:03] Speaker 01:
You're not trying to change it wholesale.

[00:07:05] Speaker 01:
So you would want to do a short-chain ester and see if you get close to the lipophilicity.

[00:07:12] Speaker 03:
All of these are possibilities.

[00:07:14] Speaker 03:
Right.

[00:07:14] Speaker 03:
And that's what UCB did.

[00:07:18] Speaker 03:
But it's not clear to me why it's necessarily obvious that one would do this.

[00:07:25] Speaker 03:
And if you look at, I think it's

[00:07:30] Speaker 03:
claim that's specific to an isobuterol ester.

[00:07:38] Speaker 03:
And what tells you to make claim five?

[00:07:44] Speaker 03:
Claim five is specific to two salts in isobuterol ester.

[00:07:50] Speaker 01:
So you've got, you would be selecting from a narrow range of short-chain.

[00:07:55] Speaker 03:
In other words, you know that's good.

[00:07:58] Speaker 03:
And you're looking backwards.

[00:07:59] Speaker 03:
You're looking backwards and saying, well, sure, doing these things results in a good product.

[00:08:06] Speaker 03:
But looking forward from 5-HMT, it isn't necessarily clear to go to these kinds of products.

[00:08:15] Speaker 01:
I disagree with that.

[00:08:16] Speaker 01:
So you're wanting to tweak the lipophilicity to be closer to tolteridine.

[00:08:22] Speaker 01:
So you would want to start with small incremental changes.

[00:08:26] Speaker 01:
Dr. Patterson talks about he applied the Lipinski rule of five and explained why, for example, you wouldn't do a diaster because it would make it too lipophilic.

[00:08:36] Speaker 01:
The same rationale would apply for adding a much longer chain.

[00:08:41] Speaker 01:
It would make it too lipophilic.

[00:08:44] Speaker 01:
Really, when you have tolteridine that's successful, that would, you'd want to aim to have a lipophilicity close to tolteridine.

[00:08:53] Speaker 01:
So you don't want to

[00:08:55] Speaker 01:
use an ester or any other prodrug that would be too, radically change it too much.

[00:09:02] Speaker 01:
So I don't know if that answers sufficiently.

[00:09:04] Speaker 01:
The two, the five, the... Okay.

[00:09:11] Speaker 01:
Okay.

[00:09:13] Speaker 01:
One other reason that you would want to modify 5-HMT does have to do with the existence of a patent that covers 5-HMT, the Johansson patent.

[00:09:23] Speaker 01:
This was raised in a footnote in the petition that referenced a declaration of Dr. Patterson, who's an expert in drug discovery and development, making commercial molecules.

[00:09:35] Speaker 01:
He explained that if there's a patent that covers a molecule, you'd want to change that because you're not going to get a patent on it, so why invest the money in it?

[00:09:44] Speaker 01:
And you don't want to infringe that patent.

[00:09:47] Speaker 01:
So it was a foreign patent, and there'd be a US counterpart.

[00:09:51] Speaker 01:
motivation was dismissed.

[00:09:54] Speaker 04:
Is that an automatic motivation?

[00:09:56] Speaker 04:
As a matter of law, anytime a compound is patented, it's an automatic motivation to modify that compound?

[00:10:06] Speaker 04:
I mean, there's other considerations that would take place too, right?

[00:10:09] Speaker 04:
Maybe you could license it.

[00:10:11] Speaker 04:
Maybe it's really expensive and unpredictable and time consuming to do all this kind of research to

[00:10:20] Speaker 04:
to make a series of modifications or to explore whether to modify a compound that's been patented.

[00:10:29] Speaker 04:
I'm just wondering if that's good enough of a motivation to find a compound that is under a patent and then decide, okay, I'm going to set up a big lab and engage in a series of experiments to modify that compound.

[00:10:43] Speaker 01:
Well, I think making an ester prodrug is a bit

[00:10:48] Speaker 01:
quite a bit less than setting up the big lab and doing all the work.

[00:10:51] Speaker 04:
Pro drugs are simple?

[00:10:53] Speaker 01:
An ester pro drug is not that hard.

[00:10:55] Speaker 01:
There was expert testimony by patent owners that it was explaining that it was not that hard.

[00:11:01] Speaker 01:
Is there contrary expert testimony explaining that it is hard?

[00:11:04] Speaker 01:
And the same experts also did say it was hard.

[00:11:07] Speaker 01:
It all depends upon the pro drug you want to use, but an ester pro drug should be a simple

[00:11:17] Speaker 01:
I believe that the testimony is something the degree in chemistry should be able to do this.

[00:11:24] Speaker 01:
But back to your question about is a patent an automatic motivation?

[00:11:27] Speaker 01:
I don't know if it's an automatic motivation in maybe in all fields, but in drug discovery where you're going to spend a lot of money to develop a new molecule, you want to make sure you're not infringing and that you can get a patent.

[00:11:41] Speaker 01:
So many litigations come to this court.

[00:11:43] Speaker 01:
for antifilins having to do with the patents on the drug.

[00:11:47] Speaker 01:
There's so much money involved in it.

[00:11:50] Speaker 01:
And Dr. Patterson testified to this in his declaration that this is a consideration that you would keep, that you would take, because you need to make sure that this is a commercially viable molecule.

[00:12:06] Speaker 03:
If there's nothing further, we'll save your rebuttal time.

[00:12:09] Speaker 01:
Well, I'd like to quickly jump on to

[00:12:13] Speaker 01:
what, what we view as, as some of the errors that the board made in this case.

[00:12:21] Speaker 01:
They, they, they seemed to require experimental evidence from the Amerigen, whereas they didn't require that from the, the patent owner, UCB.

[00:12:32] Speaker 01:
They also required Amerigen to find modifications in analogous art, like compounds with the same mechanism of action.

[00:12:42] Speaker 01:
compounds with the same chemical class, compounds with the same treatment, whereas they didn't require that for UCB.

[00:12:51] Speaker 01:
For example, looking for prodrugs.

[00:12:55] Speaker 01:
They ask the question, well, there, this hasn't been shown to have, to occur, prodrugs for anti-muscarinics.

[00:13:02] Speaker 01:
Amerigen, you haven't showed that.

[00:13:03] Speaker 01:
Amerigen, you haven't shown prodrugs of diphenylpropylamines.

[00:13:08] Speaker 01:
Amerigen, you haven't shown prodrugs of overactive bladder.

[00:13:12] Speaker 01:
But this is just a chemical reaction in a lab.

[00:13:17] Speaker 01:
When then when Amerigen did provide evidence in analogous art, such as, you know, such as for the salts, that was dismissed and instead the board relied on a conclusory statement.

[00:13:30] Speaker 01:
For example, salts, ephesoteridine,

[00:13:33] Speaker 01:
is the tartrate salt.

[00:13:35] Speaker 01:
Oxybutyne is the chloride salt.

[00:13:37] Speaker 01:
Oxybutyne is an overactive bladder drug.

[00:13:39] Speaker 01:
Tolteridine is an anti-muscarinic, is a diphenylpropylamine, and is used for overactive bladder.

[00:13:47] Speaker 01:
So why should we, why should the board disregard that evidence in the same category of molecules, mechanism of action, and method of treatment, but yet ignore it another?

[00:14:03] Speaker 03:
You're into the time you wanted to save for the bottle.

[00:14:06] Speaker 01:
OK.

[00:14:06] Speaker 01:
I will save that.

[00:14:07] Speaker 01:
Thank you.

[00:14:11] Speaker 03:
Is it Mr. Olke?

[00:14:13] Speaker 00:
That's correct, Your Honor.

[00:14:21] Speaker 00:
Jeff Olke on behalf of the Appellee UCB Pharma GmbH.

[00:14:26] Speaker 00:
I'll start with addressing the merits, and I can get to the standing issue at the end if Your Honors wish.

[00:14:33] Speaker 00:
The 650 patent is a patent that has been tried on the same obviousness theory three times.

[00:14:41] Speaker 00:
That obviousness theory has led to the same result three times, and that is that the claim subject matter of the 650 patent would not have been obvious to a person of ordinary skill in the art.

[00:14:53] Speaker 00:
The standard for reviewing the board's decision is substantial evidence, and the essence of

[00:15:02] Speaker 00:
Amerigen's dispute in their appeal brief is that the board weighed the evidence and sided with the patentees' evidence over Amerigen's evidence and Amerigen's experts' evidence.

[00:15:18] Speaker 00:
But substantial evidence, it's met multiple times in this decision by the board.

[00:15:25] Speaker 00:
At least six different critical findings of fact are made by the board weighing the evidence from the petitioner

[00:15:32] Speaker 00:
from the patentee, from the experts, from the evidence that's submitted as part of that record.

[00:15:39] Speaker 00:
And in some instances, they did find the petitioner's evidence sufficient.

[00:15:44] Speaker 03:
Is it accepted that 5-HMT is a lead compound?

[00:15:49] Speaker 00:
Well, we dispute that, Your Honor.

[00:15:50] Speaker 00:
We don't believe 5-HMT should be a lead compound.

[00:15:54] Speaker 00:
The board did find that it was a lead compound, but our view is that 5-HMT has never been used as a drug as of the prior art.

[00:16:02] Speaker 00:
So looking at the prior art, all the evidence relating to 5-HMT is as a metabolite.

[00:16:08] Speaker 00:
It had never been orally administered.

[00:16:10] Speaker 00:
And there's a very big difference between how something works as a metabolite and how it works as an orally administered drug.

[00:16:17] Speaker 00:
All of that was unknown whether or not 5-HMT could be administered.

[00:16:22] Speaker 00:
But that does go to the first finding of fact, which I think is critical and is foundational to Amerigen's argument.

[00:16:28] Speaker 00:
And that is there would have been a motivation

[00:16:32] Speaker 00:
to modify 5-HMT.

[00:16:34] Speaker 00:
And their argument is, if you look in the petition, the argument is, well, there's a bioavailability problem with 5-HMT.

[00:16:42] Speaker 00:
What's that bioavailability problem?

[00:16:44] Speaker 00:
Basically, that it wouldn't be absorbed into the bloodstream if it's royally administered.

[00:16:49] Speaker 00:
They back away from that in their appellate argument.

[00:16:52] Speaker 00:
If you notice in their appeal brief, they start to switch to lipophilicity and say, well, we mentioned bioavailability, but we're really talking about lipophilicity.

[00:17:01] Speaker 00:
But bioavailability, why did they back away from it?

[00:17:03] Speaker 00:
Because the board properly found this record shows 5-HMT probably doesn't have a bioavailability problem.

[00:17:11] Speaker 00:
And Dr. Rausch, who is the patentees expert, put in evidence of many drugs that have lipophilicity below and above 5-HMT that are perfectly well absorbed when they're orally administered.

[00:17:25] Speaker 00:
So it actually fits in a range of drugs that have a lipophilicity higher and lower.

[00:17:30] Speaker 00:
All suggestive, the bioavailability wouldn't be a problem.

[00:17:34] Speaker 00:
It wouldn't cause a person with an ordinary skill to modify 5-HMT.

[00:17:38] Speaker 03:
But assuming 5-HMT is a lead compound, your opponent says, well, making a prodrug and covering up the two-hydroxy group is a simple thing to do.

[00:17:59] Speaker 00:
That's their position, Your Honor.

[00:18:00] Speaker 00:
It's very easy to say that after the fact.

[00:18:03] Speaker 00:
This is another one of the board's findings.

[00:18:05] Speaker 03:
They looked at this issue of the two... You say that just before us engineering.

[00:18:08] Speaker 00:
That's what it is.

[00:18:09] Speaker 00:
It's looking at the solution after the fact.

[00:18:13] Speaker 00:
It's hindsight.

[00:18:14] Speaker 00:
How would you know to only focus on the two position and not look at the five position?

[00:18:19] Speaker 00:
There is evidence in dispute from both parties on this point.

[00:18:24] Speaker 00:
Dr. Rauch said,

[00:18:25] Speaker 00:
There's plenty of evidence you would try it, both the two position and the five position.

[00:18:29] Speaker 00:
In fact, the prior art that is put forward by Amerigen, their main art on prodrugs, the Vanguard reference and the Vanguard PCT reference, both talk about diesters.

[00:18:44] Speaker 00:
What is a diester?

[00:18:45] Speaker 00:
A diester in our case is you make a change at the two position and the five position.

[00:18:50] Speaker 00:
And in fact, two of the three

[00:18:52] Speaker 00:
preferred embodiments in the Vanguard PCT, they're diesters.

[00:18:57] Speaker 00:
So the record that has been put forward by Amerigen actually suggests, do a diaster, make a change at two, make a change at five, and what Dr. Rausch found was he did a calculation.

[00:19:10] Speaker 00:
He said you look at those two positions, even if you do simple

[00:19:13] Speaker 00:
simple esters.

[00:19:14] Speaker 00:
And you wouldn't, because Bungard talks about many other different possibilities.

[00:19:19] Speaker 00:
If you just do simple esters at those two positions, you have 86 at one, 86 at the other, 86 when you do a diaster, and if you do a mixed diaster, do one type of ester at one position and a different one at the other.

[00:19:31] Speaker 03:
What's the 86?

[00:19:32] Speaker 03:
All the different alkyl groups?

[00:19:33] Speaker 00:
That's right.

[00:19:34] Speaker 00:
C2 to C6, you get it to 86.

[00:19:36] Speaker 03:
But that's a claim one.

[00:19:37] Speaker 03:
Are all these claims presented together?

[00:19:40] Speaker 00:
That's right.

[00:19:41] Speaker 00:
That's right.

[00:19:41] Speaker 03:
In fact, this...

[00:19:42] Speaker 00:
That's right.

[00:19:42] Speaker 00:
They argued them really based on feciterity in itself.

[00:19:46] Speaker 03:
Which is basically claim five.

[00:19:48] Speaker 00:
That's right.

[00:19:48] Speaker 00:
The isobuterol substituent.

[00:19:51] Speaker 00:
One specific substituent.

[00:19:53] Speaker 00:
And that specific chemical modification is nowhere in this record in the prior art.

[00:19:58] Speaker 00:
They don't even try to argue that isobuterol is shown anywhere in this prior art.

[00:20:03] Speaker 00:
And again, the board found that.

[00:20:05] Speaker 00:
And they've sided with the evidence submitted, substantial evidence submitted by the patentees expert,

[00:20:12] Speaker 00:
And that was, there is nowhere in this record pointing to the specific molecular modification.

[00:20:18] Speaker 00:
And that specific molecular modification is the isobuterol group.

[00:20:21] Speaker 00:
They don't even have a reference that teaches that and shows that.

[00:20:24] Speaker 00:
They just say, well, the Vanguard treatise, which is a general treatise on prodrugs, talks about a number of different prodrugs.

[00:20:33] Speaker 00:
And one of them is alkyl esters.

[00:20:36] Speaker 00:
But there's many other possibilities.

[00:20:38] Speaker 00:
There's carbonates, carbonates,

[00:20:40] Speaker 00:
many others they could have tried, all of which are mentioned and talked about and described in the Vanguard reference, their own reference.

[00:20:47] Speaker 00:
In addition to that, the other types of prodrugs that were put forward by Amerigen, the Vanguard PCT is the other reference that they disclosed, but that's morphine.

[00:21:02] Speaker 00:
It's a transdermal morphine.

[00:21:04] Speaker 00:
It's not even orally administered.

[00:21:05] Speaker 00:
And certainly morphine is not a type of compound you would be looking to

[00:21:10] Speaker 00:
if you're making a prodrug of a diphenylpropylamine or a prodrug of an OAB drug, an incontinence drug like this.

[00:21:18] Speaker 03:
What about standing?

[00:21:20] Speaker 03:
And the idea that they agree not to mock it, if their argument is that we could reverse and so the patent would be not be blocking it?

[00:21:36] Speaker 00:
Your Honor, if I can just talk about the unique set of facts

[00:21:39] Speaker 00:
that got us to this appeal, and to address your question.

[00:21:43] Speaker 00:
And that is, in 2013, there were a series of first filers that challenged the patents on this drug.

[00:21:51] Speaker 00:
Amerigen was one of them.

[00:21:53] Speaker 00:
So they filed a paragraph four certification against five patents, including this patent, a 650 patent.

[00:21:59] Speaker 00:
We went to trial against them in the District of Delaware.

[00:22:03] Speaker 00:
And on all patents, all claims found valid and infringed.

[00:22:08] Speaker 00:
The court there then put in an injunction against those first filers.

[00:22:12] Speaker 00:
And what did that injunction do?

[00:22:14] Speaker 00:
It says they cannot have approval of their ANDA until these patents expire, including the 650 patent.

[00:22:22] Speaker 00:
It expires in 2022.

[00:22:25] Speaker 00:
And they had the opportunity at that point, with their paragraph 4 certification, which is a statement to the FDA, we're challenging this patent, they had the opportunity at that point to appeal that decision.

[00:22:38] Speaker 00:
they chose not to.

[00:22:39] Speaker 00:
Why?

[00:22:39] Speaker 00:
Because they didn't want to have attorney's fees against them.

[00:22:42] Speaker 00:
And so in exchange for are not pursuing attorney's fees in the district court, they agreed not to pursue an appeal.

[00:22:50] Speaker 00:
They gave it up.

[00:22:51] Speaker 00:
And when that happens, they automatically convert to a paragraph three certification.

[00:22:57] Speaker 00:
What is a paragraph three certification?

[00:22:59] Speaker 00:
That's telling the FDA, we're not seeking approval until this patent expires.

[00:23:04] Speaker 00:
So as far as the FDA is concerned, Amerigen's

[00:23:08] Speaker 03:
But if we reverse and invalidate it, that's the equivalent of it expiring, isn't it?

[00:23:17] Speaker 00:
Well, it's actually more complicated than that, Your Honor.

[00:23:20] Speaker 00:
It goes beyond that.

[00:23:22] Speaker 00:
As Mr. Harris said, there's a number of issues that go to whether it would be delisted at that point.

[00:23:29] Speaker 03:
But this is only standing here, enabling them to argue the appeal.

[00:23:35] Speaker 00:
But standing requires an injury in fact.

[00:23:38] Speaker 00:
And that injury in fact, they seem to change what is that in this case.

[00:23:43] Speaker 00:
They say, well, maybe it's the fact that the patent is valid.

[00:23:46] Speaker 00:
That's one statement they make in their briefing.

[00:23:48] Speaker 02:
What about the fact that when the time when the patent might be delisted, if this case has the impact of causing the patent to be delisted off the orange book,

[00:24:01] Speaker 02:
then isn't it correct that there could be a difference in time when they would be free in order to go on the market?

[00:24:08] Speaker 00:
If there comes a time eventually in which the patent is delisted, it may eventually lead to a time in which they could get approval.

[00:24:15] Speaker 00:
But there's a lot of possibilities in there before that could take place.

[00:24:18] Speaker 02:
Why don't you walk through that possibility?

[00:24:20] Speaker 02:
Because I'm not understanding it.

[00:24:25] Speaker 00:
this court were to invalidate the 650 patent.

[00:24:28] Speaker 00:
And I'm happy to talk about all the reasons why I don't think that should be the case.

[00:24:32] Speaker 00:
But if, hypothetically, if the 650 patent were invalidated, the FDA would have to make a decision on whether or not to delist it.

[00:24:43] Speaker 00:
And they would have to do that in part based on whether anyone has first filer status on the basis of that patent.

[00:24:51] Speaker 00:
So there were a number of first filers and some of them settled.

[00:24:55] Speaker 00:
So they were not enjoined by the district court.

[00:24:59] Speaker 00:
So if one of those first filers met all their other requirements, it's possible that they will have first filer exclusivity.

[00:25:07] Speaker 00:
That's correct.

[00:25:09] Speaker 02:
That's correct.

[00:25:11] Speaker 00:
Would be 180 days from when they can first market.

[00:25:15] Speaker 00:
That's correct.

[00:25:16] Speaker 00:
After that point in time, then there may be a time in which it would be delisted.

[00:25:20] Speaker 04:
Is there anything that would stop the FDA from delisting at that point, after the exhaustion of the 180-day exclusivity?

[00:25:28] Speaker 00:
Well, subject to our not appealing this decision further, I can't think of anything that would go beyond that, Your Honor.

[00:25:37] Speaker 00:
But these are a lot of possibilities that are all self-inflicted

[00:25:44] Speaker 00:
because they converted to a paragraph 3.

[00:25:46] Speaker 00:
They chose that.

[00:25:48] Speaker 00:
If you look at the case law on standing, it has to be an injury, in fact, traceable to the conduct of the party that the case is against, in that case, in our case, UCB.

[00:26:00] Speaker 00:
But it isn't our activity, our conduct that has led to this stage.

[00:26:04] Speaker 00:
The conduct that led to this stage is their decision to no longer challenge the patent.

[00:26:10] Speaker 00:
There is no case in which a paragraph three filer, which is a statement to the FDA, we will not challenge this patent.

[00:26:17] Speaker 00:
We will wait until this patent expires.

[00:26:20] Speaker 00:
That's what paragraph three is.

[00:26:21] Speaker 00:
It's not a statement that, please go ahead and still invalidate the patent.

[00:26:25] Speaker 00:
It is, we're going to honor this patent and wait until it expires.

[00:26:30] Speaker 00:
They cannot infringe this patent.

[00:26:33] Speaker 00:
It's not possible.

[00:26:34] Speaker 00:
There is an injunction in place by the District of Delaware, which they did not contest.

[00:26:40] Speaker 00:
which says you cannot approve this product until the patent expires.

[00:26:46] Speaker 04:
If the patent were to be invalidated earlier than 2022 and the 180-day exclusivity expires, let's say this all happens a year from today and then the patent gets delisted.

[00:27:02] Speaker 04:
I assume the other side could go to the District of Delaware and ask for the injunction to be modified?

[00:27:08] Speaker 00:
They say that in their papers, Your Honor, but there's no case where this has actually occurred.

[00:27:13] Speaker 00:
So I presume that's what they would try.

[00:27:16] Speaker 00:
But as I said, there is no case where a paragraph three filer who is honoring a patent, that's what they're telling the FDA, has gone into an Article III court and said, find the patent invalid or delist the patent.

[00:27:30] Speaker 00:
Sorry, Your Honor.

[00:27:30] Speaker 02:
That's all right.

[00:27:32] Speaker 02:
Do I understand correctly that the difference in time for when you have, I think, four or five patents

[00:27:38] Speaker 02:
And the patented issue here has an expiration date that's about three years later than the expiration date of the other patents that are in that paragraph through certification.

[00:27:50] Speaker 00:
That's right.

[00:27:50] Speaker 00:
2019 are the four other patents.

[00:27:54] Speaker 00:
They expire in 2019.

[00:27:55] Speaker 00:
The 650 patent expires in 2022, so it's a three-year difference.

[00:28:00] Speaker 00:
So even when they filed their appeal, 2019 was

[00:28:07] Speaker 00:
over a year and a half out.

[00:28:08] Speaker 00:
So that's another reason why there's an immediacy issue, and we brief that with respect to the Janssen case.

[00:28:15] Speaker 00:
Of course, we're farther along at this point, but they needed to have standing when they filed their appeal.

[00:28:20] Speaker 00:
And there's a question of whether that's the case.

[00:28:22] Speaker 00:
But I really want to emphasize this point, because I'm not sure from the questions that I want to make sure it's clear from the briefing.

[00:28:32] Speaker 00:
There has never been a case in which a paragraph three filer

[00:28:37] Speaker 00:
has been able to come to an Article III court and seek invalidation.

[00:28:41] Speaker 00:
Can't do it.

[00:28:42] Speaker 00:
They can't file a declaratory judgment in any district court.

[00:28:45] Speaker 00:
It wouldn't be possible under the Hatch-Waxman scheme.

[00:28:48] Speaker 00:
Hatch-Waxman says you have to be a paragraph 4 filer to have that opportunity.

[00:28:53] Speaker 00:
If you have a paragraph 3, you have to wait.

[00:28:56] Speaker 00:
That's the way the Hatch-Waxman scheme is set up.

[00:28:59] Speaker 03:
So if we agree with you, the question of the obviousness is moot.

[00:29:05] Speaker 00:
That's correct, Your Honor.

[00:29:07] Speaker 00:
certainly have all the reasons that I gave why these claims.

[00:29:10] Speaker 03:
But if I don't have standing to appeal, then we don't have that issue.

[00:29:15] Speaker 00:
That's correct, Your Honor, and that's our position.

[00:29:20] Speaker 00:
Any other questions, Your Honor?

[00:29:22] Speaker 03:
No, thank you very much, Counsel.

[00:29:24] Speaker 03:
Mr. Heer has got a minute and 45 seconds.

[00:29:28] Speaker 01:
I've got a couple of quick points I'd like to make, really, to focus on the standing.

[00:29:33] Speaker 01:
Talk a little bit about the statute that governs this.

[00:29:37] Speaker 01:
Mr. Opie mentions Janssen case.

[00:29:38] Speaker 01:
Janssen was the pre-MMA law which modified the Food, Drug, and Cosmetic Act to include forfeiture provisions.

[00:29:47] Speaker 01:
So this comes to if you invalidate this patent, the question was when would the patent get delisted?

[00:29:57] Speaker 01:
You invalidate the patent and people, any generic ANDAs with a P4 to the 650 don't launch.

[00:30:04] Speaker 01:
within a certain amount of time they forfeit their exclusivity.

[00:30:09] Speaker 01:
Or if they do launch in a certain amount of time, 180 days, that exclusivity expires.

[00:30:16] Speaker 01:
At that point, either through the forfeiture, if everyone who has a P4 in the 650 patent forfeits, the patent would be able to be delisted.

[00:30:24] Speaker 01:
Or once the 180 days is expired from the first person to launch, then it would expire.

[00:30:31] Speaker 01:
I'd also like to point out that

[00:30:33] Speaker 01:
Since filing the briefs, there's a couple decisions from this Court having to do with standing that are relevant to this, that are closer to the.

[00:30:42] Speaker 03:
You say since filing the briefs.

[00:30:44] Speaker 03:
Yes.

[00:30:45] Speaker 03:
Wouldn't you, shouldn't you have sent them to us before today?

[00:30:48] Speaker 01:
I expect you're correct on that.

[00:30:54] Speaker 04:
Let me ask you a question.

[00:30:56] Speaker 04:
The other side is talking about your settlement of that earlier litigation with them.

[00:31:02] Speaker 01:
Okay.

[00:31:02] Speaker 04:
where in their view, you voluntarily, willingly moved over to a paragraph three certification.

[00:31:09] Speaker 04:
And so because of your voluntary act of doing that, you are essentially stopped from claiming any kind of controversy as to the patent, and so therefore shouldn't be considered to have standing here.

[00:31:27] Speaker 04:
Could you speak to that?

[00:31:31] Speaker 04:
on your own volition moving over to paragraph three, and how we should think about that with respect to standing here.

[00:31:37] Speaker 01:
I'd raise two points.

[00:31:39] Speaker 01:
One, sometimes companies make a business decision that it's better to settle than to go forward.

[00:31:47] Speaker 01:
Plus, we have different standards for an IPR versus a district court.

[00:31:52] Speaker 01:
So that would be an additional reason that we might want to join into an IPR.

[00:31:58] Speaker 01:
So a marriage and joined into a petition

[00:32:01] Speaker 01:
once it was instituted.

[00:32:02] Speaker 02:
When you say join into an IPR, you're saying before the patent office, right?

[00:32:08] Speaker 01:
Correct, correct.

[00:32:08] Speaker 02:
Or are you talking about the appeal before this court?

[00:32:10] Speaker 02:
Because obviously, anybody can, and there's no limitations in the PTO for filing.

[00:32:17] Speaker 02:
I realize you had limitations for filing, but you're able to join.

[00:32:22] Speaker 01:
Hedge funds can file.

[00:32:23] Speaker 02:
It's different for entering into these proceedings with the agency as opposed to an appeal.

[00:32:28] Speaker 02:
to an Article III court.

[00:32:29] Speaker 02:
You agree with that, right?

[00:32:32] Speaker 01:
Yes, there are differences.

[00:32:34] Speaker 02:
So is your point that the standing requirements for district court declaratory judgment action is different than the standing requirements for an appeal here?

[00:32:45] Speaker 01:
No.

[00:32:48] Speaker 01:
Make sure I'm answering your question correctly.

[00:32:50] Speaker 01:
So an appeal of a

[00:32:53] Speaker 01:
where there's a provision that permits an appeal from an agency action like an IPR here, there's a relaxation of the redressability and the traceability or immediacy of the challenge action.

[00:33:09] Speaker 01:
But you still have to prove the injury in fact.

[00:33:11] Speaker 01:
So that's what I've been focused on, is the injury in fact that we have here, where there's a listing of the patent in the Orange Book that prevents us from launching.

[00:33:21] Speaker 01:
We have tentative approval.

[00:33:23] Speaker 01:
We've taken all the actions that case law indicates should show that we have standing, that we have an injury in fact.

[00:33:34] Speaker 01:
I'm not sure if I answered your question.

[00:33:38] Speaker 03:
One final comment.

[00:33:40] Speaker 01:
Yes, sir.

[00:33:41] Speaker 03:
If you have a final comment.

[00:33:43] Speaker 01:
Oh, I'm sorry.

[00:33:43] Speaker 01:
I thought you had a final comment.

[00:33:45] Speaker 03:
No, I think you will take the case under advisement.

[00:33:48] Speaker 01:
Thank you.