[00:00:00] Speaker 03:
Our next case for argument is 25-1236, Exelis v. MSN Laboratories. Mr. Klein, please proceed when you're ready.

[00:00:11] Speaker 02:
Good morning. May it please the Court.

[00:00:13] Speaker 02:
The core issue on appeal, which I do not believe this Court has ever addressed, is whether a patented polymorph genus that claims an undisclosed polymorph violates Section 112, and it does, because polymorphs are notorious for being highly unpredictable. The trial court found, and there's no dispute, that the inventors here actually invented and disclosed only two polymorphs.

[00:00:44] Speaker 02:
Yet the court read the patents as claiming a broader polymorph genus. This is now undisputed.

[00:00:53] Speaker 02:
A skilled artisan can't visualize polymorphs or recognize members of a polymorph genus because you can't predict anything about new polymorphs. As plaintiff's experts conceded, a skilled... Can I interrupt you for a minute?

[00:01:08] Speaker 00:
Yes.

[00:01:10] Speaker 00:
The district court relied on a specific test for determining whether a written description was satisfied or not. Do you have any challenge to...

[00:01:23] Speaker 00:
the judge's reliance on, I think it was he emphasized that there was structure and there was a process. You might take issue with his factual findings, but do you have a challenge to the legal test that he was applying?

[00:01:43] Speaker 02:
I do, Your Honor, because the court relied on the term crystalline, which is a broad outline of a genus perimeter. That's the quote from the Regents case. And what the court said is if there's no functional limitation in the claims, You can zoom way out and basically say this is a claim that covers polymorphs and therefore written description is satisfied. And that is not the law. The law, and you can go back to Ariad, makes it clear you have to consider the predictability or unpredictability of the art.

[00:02:20] Speaker 02:
And the district court completely discounted the fact that when you're talking about polymorphs, it's hard to think of technology that's more unpredictable.

[00:02:29] Speaker 00:
That feels very fact-specific. My question really wasn't exactly that. I understood that my question was more basic, which is that the judge was relying on Ariadne and GlaxoSmithKline to understand what the test is, just generally the legal standard. You could either have enough species examples that you disclose the genus, or you could have a structure and maybe a process of making that structure from which you could divine that that would be enough to disclose the genus.

[00:02:59] Speaker 00:
Do you agree that that test, broadly stated, is the right legal standard? The court cited the right legal standard. That's all I wanted to know. Thank you.

[00:03:10] Speaker 02:
And the standard of review is clear error because written description is considered a question of fact. But there are nine findings of fact. The first nine we're not challenging on appeal. The only finding of fact we're challenging on appeal is the ultimate conclusion that the disclosure here satisfies the legal standard. That's application of the law. There's no substantive difference between what we have in this appeal and a summary judgment argument.

[00:03:38] Speaker 02:
And so we're saying that the court misapplied the law. I'm not saying the court cited the wrong legal standard.

[00:03:48] Speaker 02:
And that gets to the point that crystalline is just the fence. And if you call... You're calling the claims having a common crystalline function is basically the same thing as saying the claims cover polymorphs. And that can distinguish what's inside the fence from what's outside the fence, but you can't visualize or recognize what's inside the fence.

[00:04:11] Speaker 00:
Your view is that because only N1 and N2 were disclosed...

[00:04:16] Speaker 00:
S is not included. I mean, I guess you can't go beyond that, in other words. Right, right. Their patent should be limited to N1 and N2. Absolutely. Do you have any cases where we have held that you're just limited to the examples that are disclosed in the specification? In this kind of area.

[00:04:38] Speaker 02:
That's why I started, because I'd never seen a claim, a claim that covers a polymorph genus before, and I've been doing this a long time. Typically, you claim a polymorph, and you describe it with XRPD peaks, and that's what MSN did with its own patent. MSN has its 4MS patent, and there was no obviousness rejection, even though the exact same disclosure, the exact same disclosure here was prior art, There was no obviousness objection.

[00:05:08] Speaker 02:
There's no unexpected results. There's no functional limitation. And that's because it has been well recognized in the court's precedent polymorphs are unpredictable. If you find a new polymorph, that itself can be known.

[00:05:21] Speaker 00:
I assume that there's factual evidence on that, too. I mean, like, in this case, the claims are to a particular...

[00:05:32] Speaker 00:
Habos and Antinib or the claimed salt in crystalline form, right? Correct. Okay. But there's lots of factual evidence and expert testimony on just how broad that is, right, and how many different varieties there is, right?

[00:05:49] Speaker 00:
And it's not claimed based on function, right? It's based on structure. Do I have that correct?

[00:05:54] Speaker 02:
You are correct. There's no functional limitation, but Ariad also makes it clear that the written description applies differently if the art's unpredictable. And their expert conceded a person of skill in the art, I'm quoting, would not know whether other crystalline forms even existed based on the disclosure of the specification, Appendix 2062.

[00:06:15] Speaker 02:
So you can't even tell what's in the genus if anything else is in the genus.

[00:06:21] Speaker 00:
Can I move you just momentarily to another issue? As you know, we've had a flurry of motions in front of the court this week, starting with yours, in the weird situation where you, who raised an issue, you're now arguing that you don't have standing, even though you're the one that raised the issue. Do I have that right? Well, when we raised the issue, we did have standards. It's okay. I understand. But you're saying your issue that you've raised is moot.

[00:06:51] Speaker 00:
So why haven't you just withdrawn it?

[00:06:54] Speaker 00:
I mean, it's your issue to withdraw.

[00:06:57] Speaker 02:
I think we have to move to dismiss for lack of jurisdiction because the relief we want is to ensure that there is no issue preclusion. I mean, that's the concern. If we just drop the appeal, then the final judgment below would stand. But you're arguing you don't have a standing.

[00:07:17] Speaker 02:
Well, we don't.

[00:07:18] Speaker 00:
I mean, you're arguing it's moot, right? We're arguing it's moot. Currently, we cannot address this issue, right? That's what you're arguing.

[00:07:25] Speaker 02:
Yes, correct. Okay. Okay.

[00:07:27] Speaker 02:
But to be clear, we did have standing, and the matter was not moved when we noticed our appeal. I understand the difference. Thank you for that. And we were responding, I mean, to be candid, we got the court's order, we did the research, we reached out to opposing counsel, we met and conferred, and we decided the right thing to do was to move to dismiss.

[00:07:49] Speaker 00:
It's kind of funny because you're arguing on the one hand, you're saying, The issue is not ripe or not moot because collateral estoppel effects could apply. But at the same time, you're saying collateral estoppel effects won't apply. Therefore, that's why the issue is moot. And at the same time, you're arguing... because there might be collateral-stoppable effects, please vacate the decision below under U.S.

[00:08:23] Speaker 00:
Bancorp.

[00:08:25] Speaker 00:
How do you bring those two positions you have? You've got a fine line that you're trying to weave there.

[00:08:33] Speaker 02:
We believe the issue is moot because there is – I mean, we acknowledge there's a hypothetical possibility of collateral consequences.

[00:08:43] Speaker 00:
We're just – our position is – I mean, opposing counsel is arguing the collateral stop. They need to have the ruling for collateral purposes. Right.

[00:08:50] Speaker 02:
And our position is they are vastly overstating the importance. This is not a threshold situation like a statute of limitations – a form selection clause, what a statute means. This is potential issue preclusion relating to one aspect of one defense among many with a co-defendant who will not be stopped in a trial that is set to happen in November. There might not even be a decision by the court by then. And even if they file an issue preclusion motion, Judge Andrews might say, why should I even bother ruling on this because I've got another defendant who's not going to be precluded?

[00:09:30] Speaker 00:
If we were told the issue was moot, I thought that if an appellate court held that an issue on appeal was moot, that collateral estoppel would not apply.

[00:09:42] Speaker 00:
You know, I would think that because the parties were not able to continue to challenge the the issue on appeal, how could there possibly be any unstoppable effect? But maybe my understanding of the law is incorrect. I agree with you, but there is... I mean, do you have case law, you know, that says otherwise?

[00:10:04] Speaker 02:
I don't know, but the regular practice is to vacate the decision below to avoid an issue with regard to issue preclusion, so there's no question.

[00:10:17] Speaker 00:
It's not required, correct?

[00:10:19] Speaker 02:
It's not required. It's the established practice when the mootness does not occur.

[00:10:25] Speaker 00:
It's when the mootness is caused by something on the other side. Correct.

[00:10:29] Speaker 02:
Correct.

[00:10:32] Speaker 02:
If there are no further questions, I'll reserve the remaining time.

[00:10:40] Speaker 03:
Mr. Saunders?

[00:10:43] Speaker 01:
May it please the Court. The crystalline L-malate salts of cabozantinib are described and claimed by their structure, not by their function. Thank you. Written description is an issue of fact, and there's no clear error in the factual finding that the common structural features here, chemical name, the formula, and the crystalline structure, would allow a skilled artisan to visualize or recognize the claimed subject matter.

[00:11:11] Speaker 03:
And therefore the unpredictability question, is it relevant? Is that your view of it?

[00:11:15] Speaker 01:
Well, I think the parties had disputes about the size of the genus. But yes, in this court's GSK case, the solvates there had unpredictability.

[00:11:31] Speaker 01:
There was evidence in the record there. You can see in the district court opinion of sort of some of the struggles to find it. But as a matter of written description, The court said, these aren't functional claims. So we're not sort of going into unpredictability around the function. We're looking and the structure is disclosed. essentially in the exact same terms that it is claimed. And so as a matter of written description, that's the end of the analysis. There may be a separate enablement argument that we don't have here that someone would make around the unpredictability.

[00:12:05] Speaker 00:
If I understand it, because it's not described by function, as in a particular compound to achieve X or Y, that reduces some of the unknown nature of the scope of the claim. Right. Right. And so... And whether the inventor... What the inventor invented. I mean, the question, right, is did the inventor invent this? Would a person of ordinary skill in the art reading the specification understand the inventor how to have invented the scope of the claims? Right. And when you have functional languages, that makes it more complicated.

[00:12:37] Speaker 00:
Exactly.

[00:12:37] Speaker 01:
You don't know what the what is. But here... But we also know you don't have to have actual reduction to practice of every species. And so... You can have a circumstance, you know, if they had just come in and said, we're disclosing one form, and then after the fact, they're trying to say, oh, no, no, wait, we're talking about crystalline, right? But the specification is very clear. They disclose the L-malate salt. They specifically say, quote, another aspect of this disclosure relates to crystalline forms of compound one.

[00:13:08] Speaker 01:
That's the L-malate salt. So it's a direct description, and what was important to them is that crystalline form, that shared structure. And then on top of that, we have the original claims from the very beginning are claiming it in those terms, the crystalline form.

[00:13:26] Speaker 00:
L-malate. That's not dispositive, though, based on Ariad, right? I mean, Ariad's very clear that the original claims have to have a person of, you still have to apply the Ariad test to original claims.

[00:13:36] Speaker 01:
Correct. You do. I will say that when people get tripped up and not having the disclosure in the original claims, it's almost always because the original claims are using that functional language as opposed to the original claims here using the exact same structurally. So I think GSK, we think, is right on point in terms of the proper way to analyze this. And we haven't seen any case cited here that's even remotely in the ballpark.

[00:14:08] Speaker 01:
All of their structural cases, ICU medical was disclosure of spike valve, spike valve, spike valve, and then they try to claim spikeless. In the Tronzo case they cite, you essentially have a disclaimer of anything other than the conical cups.

[00:14:21] Speaker 00:
There's no criticism of certain kinds of cabozinanted, the claim salt. I'm just going to call it the claim salt.

[00:14:28] Speaker 01:
Yes, absolutely not. And they make very clear when you read that specification that you have that salt, you have crystalline structure, that's what matters. And then on top of this, it would say, we remember that this is an issue in which they bear the burden of proof, clear and convincing evidence, and they came in and tried to point to some minor differences between species. And the district court made a ruling on that, this is page 26 of the appendix, and said MSN baldly asserts that there are differences between N1, N2, and the rest of the genus without giving me a framework to evaluate such differences.

[00:15:09] Speaker 01:
Basically it says you're not showing me importance to the differences.

[00:15:13] Speaker 00:
And remember, the backdrop... And the important thing is there's no functional language that it would account for and care about those differences anyway.

[00:15:19] Speaker 01:
Exactly. And we don't have... I mean, the backdrop here, too, is we have a Hatch-Waxman case where they're saying our drug is bioequivalent to yours here. But that's not part of the written description analysis here where it's functional here.

[00:15:30] Speaker 00:
The district court judge also talked about how the specification disclosed the process by which to achieve the structure. In your view, how does that inform the analysis of whether a person of ordinary skill may understand an inventor to have invented what is claimed?

[00:15:47] Speaker 01:
Yeah, I think it certainly helps us. I'm not sure it's dispositive, but there's extensive disclosure in the specification of how to achieve crystallization.

[00:15:59] Speaker 01:
And so I think that certainly it takes any added uncertainty you would have there. It's a helpful fact.

[00:16:06] Speaker 00:
It's a helpful fact. That's positive.

[00:16:07] Speaker 01:
That's positive.

[00:16:08] Speaker 00:
All right. Do you want to talk about mootness? You are arguing that the case is not moot because of potential collateral estoppel effects in another pending case for a different set of claims in a different package, right?

[00:16:25] Speaker 01:
Correct. And to be clear, the context here, the reason we didn't burden this court with a fight about the gliding limitation is because by the time it came to make that decision, it We had the parallel patent. We've shown you the claims in the supplemental brief that we filed. And it's essentially right on point, except for... You're saying you made a strategic decision.

[00:16:52] Speaker 01:
We made a decision that the controversy at that point had shifted away from infringement of the gliding limitation to the broader context here.

[00:17:06] Speaker 01:
The fight in that parallel proceeding is over...

[00:17:12] Speaker 01:
And that fight is directly on point with the issues that they have raised in their appeal. There's a finding here by the court that following the Brown process isn't going to inherently result in the claim.

[00:17:29] Speaker 00:
Since you're getting into the merits, let me ask you a question.

[00:17:33] Speaker 00:
Did the district court clearly err in finding that there were differences? I mean, he seemed to rely on there being differences between the Brown process and the process used for at least one of the batches and seemed to equate that to the process used for all three batches. Why isn't that clearly erroneous to have relied on the submission to the FDA for one of the GMP batch and inferred that that also applied to the other two batches?

[00:18:05] Speaker 01:
Well, I think it's because the specific reference to changes there was showing, it didn't then say, oh, there are no changes in other batches. There wasn't a negative implication there. And so the specific reference to that batch was really highlighting the fact that this is an area in which there are changes. The backdrop is the argument of this follows Brown is based on its appendix 3115. It's the diagram of the different steps.

[00:18:35] Speaker 01:
It doesn't have times. It doesn't have temperatures.

[00:18:40] Speaker 01:
And so you take that plus the fact that there's an express disclosure that for one of the batches there are these changes. And then all this has to go through the lens of MSN is the party with the burden of

[00:18:55] Speaker 00:
So maybe I'm misreading the opinion, but I thought maybe, I mean, I hear what you're saying, but I thought maybe the opinion was relying on one of the batches having the changes to be all of the batches. I think it's, and if that's the case, that seems like a little, that could be wrong. At least that portion requiring a vacate remand anyway, but I don't know.

[00:19:19] Speaker 00:
But you are, your position is that How is it that you should be able to? You've got one case that you've cited to us.

[00:19:31] Speaker 00:
I think it's Comcast and the briefing of yours that we just got this morning, I think.

[00:19:38] Speaker 00:
Why is it that that case relates to this case in allowing us to consider an issue that is mute, arguably mute?

[00:19:47] Speaker 01:
I think the point is it's not mute because of that continuing effect on the parallel proceeding. That's exactly what happened in Comcast. Comcast, it was coming up from the ITC. The patent had expired, and so that particular partial exclusion order from the ITC was done upon expiration of the patent.

[00:20:07] Speaker 00:
Do you agree, though, that in Comcast it uses very, it says may, may, may, the court may consider it? There's nothing in here that's requiring consideration of the issue.

[00:20:18] Speaker 01:
Well, but I think, I mean, the argument is jurisdictional, right? So if it may consider it, then that has answered the jurisdictional question. If we get into the discretionary question, then I think this is even more decisively in our favor because what they're asking to do is take all the work that went into a full trial and these factual findings and throw it out and start over and re-litigate the exact same issues. What did the re-dispatches show?

[00:20:48] Speaker 01:
Was there an heresy? As we've cited in our supplemental brief, they're actually trying to go into those exact same issues.

[00:20:56] Speaker 00:
You are no longer contending that they infringed this claim?

[00:21:00] Speaker 01:
We are no longer contending that they infringe Claim 3 of this patent. Claim 3 of this patent.

[00:21:05] Speaker 00:
But you want us to go ahead and analyze whether Claim 3 of the patent is valid or not.

[00:21:11] Speaker 01:
Correct. I mean, the Supreme Court has recognized that invalidity and infringement can be different issues.

[00:21:20] Speaker 03:
You didn't call a DJ here, did you?

[00:21:23] Speaker 03:
You didn't file a counterclaim to the DJ?

[00:21:25] Speaker 01:
No, we did. I mean, remember, this is a Hatchwaxman case, right? So we initiated the case, and in our complaint, we asked for a declaration that the patent is not invalid.

[00:21:35] Speaker 00:
It's a little different, though. So here, the patent is not infringed, so where's the case of controversy? You're arguing there's still case of controversy based on other claims that are pending.

[00:21:46] Speaker 01:
Correct, because the...

[00:21:49] Speaker 01:
The validity, the issue that's left on appeal, which is the validity of this patent, directly carries over to the validity of the 039 patent in that. And that's why you can line up this court's factual findings, say this court made the finding, and they are arguing the exact opposite. in that other proceeding, which they can't do.

[00:22:14] Speaker 00:
Do you know what the exact issues were that this Court reviewed from the ITC action in Comcast?

[00:22:21] Speaker 01:
In Comcast, it was a mix of issues. There was a question of whether Comcast was an importer, was one of the questions. And then there were questions related to this Court's en banc decision in Suprema. Sort of the nature of...

[00:22:36] Speaker 01:
of what was coming in the X1 set-top boxes, which would then have to be combined with Comcast servers in the United States. So there was a question over whether it's an article.

[00:22:48] Speaker 01:
But to be clear, you know, on this issue of, oh, does it just have to be a threshold issue or a dispositive ruling? I mean, the...

[00:23:02] Speaker 01:
Supreme Court has a canonical case from the 80s, National Golden Taxi versus Los Angeles, and it was a taxi company. It didn't like that its license hadn't been renewed.

[00:23:13] Speaker 01:
By the time it got to the court, even if the license had been renewed, it would have been expired anyway. So it was moot in that proceeding. But the Supreme Court said this isn't moot because whether you were applying for a brand-new license – or applying for sort of further renewal in the other proceeding, your sort of new license request, it would affect how the court looked at it there. It didn't mean the court was definitely going to rule one way or the other on it. It doesn't have to be a dispositive issue. We're just talking about the constitutional minimum for there to be a case or controversy, and it is enough that We are going to have to re-litigate the exact same issues already decided by this court.

[00:23:55] Speaker 00:
But with a different claim, a different scope. I mean, I understand, very similar scope, but different scope. So you would be relying on, what would you be relying on? Issue preclusion?

[00:24:07] Speaker 01:
Yeah, issue preclusion.

[00:24:08] Speaker 00:
So to be clear. Different claim limitations.

[00:24:11] Speaker 00:
Yes, again, because... Some overlapping, some identical.

[00:24:15] Speaker 01:
Massive. I mean, we have the fight... that we're talking about there to which preclusion is going to apply is the exact same fight.

[00:24:24] Speaker 00:
It's whether Brown results in the recited one-to-one limitation. Correct.

[00:24:32] Speaker 01:
It's a little harder for them in that case because the threshold is even lower. But a fortiori, if they didn't inherently prove below the 200 part-per-million threshold here, then they will fail on the below 100 threshold.

[00:24:48] Speaker 00:
So the question here where you're arguing that our decision on appeal could relate to the question of whether a prior reference teaches a particular claim limitation.

[00:25:01] Speaker 01:
Yes, because each of your conclusions can operate on the level, and in fact it's sort of the most striking process. There's the finding here, the Brown process, no inherencies. Their expert is arguing, quote, if a POSA faithfully follows the Brown process, as Regis did, the POSA would necessarily and inherently obtain cabozantinib L-malate containing 200 parts per million or less. So we will be – there's a live case for controversy here because if this judgment goes away, if we don't resolve it as they've done on their appeal, then – we're going to end up litigating the exact same issue.

[00:25:45] Speaker 01:
And so to be clear, there are definitely cases where the future effects are too speculative. There may not ever be a second case, et cetera, et cetera. Here, even before we dropped our cross-appeal, the second case was already pending, issue was joined, and so it's an ongoing proceeding, very direct effect.

[00:26:06] Speaker 03:
Okay, thank you.

[00:26:13] Speaker 02:
Thank you. Starting with the mootness point, because that's where we ended, just very quickly. Regis did follow the Brown process. We now know that for sure, 100% sure, that will be addressed in the new litigation.

[00:26:28] Speaker 02:
And that's why they want to invoke issue preclusion, because they know that what Judge Andrews found in the first case is factually incorrect. The reality is that a Zerdy... What does that have to do with whether it's moot? Well...

[00:26:44] Speaker 03:
That, I'm explaining, I'm giving you context as to why they want to... You're just trying to color us against their argument, but without addressing the legal merit of it.

[00:26:51] Speaker 02:
Well, the legal merit, I'm giving you the context. The legal merit is that Azzurri is a co-defendant, and they are not going to be bound by issue of preclusion no matter what. This case is going to be tried in November. If Azzurri wins... On whatever theory it presents, and the patent is invalid, MSN wins. They can't assert infringement of an invalid patent. So Judge Andrews would never have to reach the question of issue preclusion if a Zerdy proves the inherent argument that they want to preclude MSN.

[00:27:24] Speaker 00:
Make sure I understand. You're saying issue preclusion can't possibly apply because it's a different party.

[00:27:29] Speaker 02:
It doesn't apply to Zerdy. I don't think they dispute that.

[00:27:34] Speaker 02:
They don't dispute that. So if Zerdy wins the consolidated case, it's a validity issue. We win too. The judge never has to address issue of preclusion. That's why it's moot and speculative. As for the polymorph issue... Do you have a legal argument?

[00:27:52] Speaker 00:
In response to Judge Moore's question, do you have any legal point you want to make on it, though? Legally, we shouldn't be thinking about collateral stopping.

[00:28:03] Speaker 02:
There's not a case directly on point with this situation. I mean, the collateral consequences we see are things like statute of limitations or form selection, which is very basic in threshold. This is very, very weedy about a particular claim in a particular defense when there are other defenses. I will also note that this is a declaratory judgment action claim.

[00:28:25] Speaker 00:
So the court has to... The contest involved a very specific issue too, right? And those are very specific issues, as specific as this, I would say. It is, but here it is... I mean, case specific.

[00:28:36] Speaker 02:
Yeah, I mean... There's not a hard and fast rule in this context with regard to mootness. You can see cases saying possible collateral consequences don't matter. Then you see cases like Comcast, just to be candid with the court.

[00:28:50] Speaker 02:
There's not a bright line I can give you. I can tell you that it's a declaratory judgment action, and under the statute, you do have discretion. If you decide, well, you know, we think it's moot, case law isn't clear, you still have discretion to say, even if it's a close call, it's a declaratory judgment action. We don't see any collateral consequences here where it's very speculative, and we're going to opt not to.

[00:29:15] Speaker 00:
You still have to have discretion.

[00:29:17] Speaker 00:
If an issue is moot, do you really think that we could consider something even though there's no actual controversy anymore?

[00:29:26] Speaker 02:
No, I'm saying the opposite. If it's moot, you don't have jurisdiction for sure. If it's a close call and you're not sure if it's moot, you still have discretion.

[00:29:37] Speaker 02:
As for the polymorph, our main point is that if you invent graphite, You can't claim a diamond. That's the crux of our argument, even though both graphite and a diamond are polymorphs of carbon. Those are two polymorphs. The claims are unique here. They claim a polymorph genus. They disclose two and only two polymorphs. No one knows how big this genus is. Plaintiff's expert doesn't know if there's a third member, if you read the disclosure. It's completely speculative, hypothetical, and unpredictable because we're talking about polymorphs.

[00:30:14] Speaker 02:
Polymorphs, to be clear, are very different from salts and solvates. I don't

[00:30:18] Speaker 03:
understand the unpredictability. I still don't. I didn't understand your first argument. I don't understand it now. Their argument is this is a claim defined by a structural similarity. That's what this predictability has to do with. That's the functional aspect. Judge Stoll started this argument by asking you, do you accept that there are two ways to establish written description support? One is functional and the other is structural. I still don't understand why you keep bringing up unpredictability when we're in a structural realm.

[00:30:47] Speaker 02:
Because the structures of polymorphs are unique. They're like snowflakes. Every polymorph is unique.

[00:30:54] Speaker 03:
I'm not a fan. Keep going.

[00:30:55] Speaker 02:
Okay. Every polymorph is distinguished from another polymorph by XRPD peaks. And that's why polymorph claims typically claim XRPD peaks. There's no way to distinguish. There's no way to know if there's another polymorph from the disclosure. There's no way to know. I see I'm out of time. Okay.

[00:31:14] Speaker 03:
All right. I thank both counsels. It's a case to take it under submission.