[00:00:00] Speaker 01:
Our next case for today is 2018-1241 Warner-Chilcott versus Teva Pharmaceuticals.

[00:00:59] Speaker 01:
Mr. Kennedy, when you're ready, please proceed.

[00:01:01] Speaker 04:
Just one second, Your Honor.

[00:01:14] Speaker 04:
May it please the Court.

[00:01:16] Speaker 04:
The District Court's non-infringement judgment is based on two reversible errors.

[00:01:20] Speaker 04:
The first error was a claim construction of the term gelling agent that deviated from the plain meaning in two respects without any basis to do so.

[00:01:28] Speaker 04:
The district court acknowledged in its summary judgment opinion that gelling agent has a plain meaning, which it articulated as a substance that gels the film composition.

[00:01:38] Speaker 04:
But it then went on on a sua sponte basis to impose a negative limitation, excluding water from the ambit of gelling agent.

[00:01:45] Speaker 04:
There is no basis in the intrinsic evidence to do so.

[00:01:48] Speaker 04:
And the intrinsic evidence doesn't come close to meeting the high standard in cases such as Thorner and Omega for imposing a negative limitation.

[00:01:58] Speaker 01:
If the term gelling agent were given its plain and ordinary meaning, and if there is absolutely no evidence in this record that one of skill in the art would understand that plain and ordinary meaning to include water, then what's wrong with what the district court did?

[00:02:16] Speaker 04:
Well, there's two steps here.

[00:02:18] Speaker 04:
The plain and ordinary meaning of water is a substance capable of gelling the film composition.

[00:02:25] Speaker 04:
And we did put in evidence from our expert, Dr. Bodmeier,

[00:02:28] Speaker 04:
showing the role that water plays in the gelling in the accused product, the molecular interactions between HPMC.

[00:02:36] Speaker 01:
But that's not the same thing.

[00:02:39] Speaker 01:
You want the plain and ordinary meaning of the word.

[00:02:42] Speaker 01:
And your expert saying that in his view, water is contributing to the gelling in a particular disclosure isn't the same thing as evidence that the plain and ordinary meaning of gelling agent to a skilled artisan would include water.

[00:02:59] Speaker 04:
Well, I think the plain and ordinary meaning of the term of skilled artisan would be any substance that gels a film composition, or as we would put it, any substance capable of gelling the film composition.

[00:03:10] Speaker 04:
And then in the infringement analysis, we showed, based on prior art describing the well-known thermodulation process, that water does gel the film composition, and that it plays a role.

[00:03:22] Speaker 03:
I think what happened here was the district court's construction was a substance that

[00:03:28] Speaker 03:
gels the composition or something like that?

[00:03:31] Speaker 04:
Yeah, the substance that gels the film.

[00:03:33] Speaker 04:
That was the first composition.

[00:03:34] Speaker 03:
So why doesn't that mean you need a substance that is actually doing the gelling, not a substance that's getting out of the way to permit other things to gel?

[00:03:47] Speaker 04:
Well, a couple things.

[00:03:48] Speaker 03:
First of all, I think the way... The gelling agent therefore has an affirmative role in the gelling process.

[00:03:54] Speaker 03:
It doesn't have this kind of

[00:03:57] Speaker 03:
get out of the room so everybody else can do gelling.

[00:04:00] Speaker 04:
Well, I'm not sure that's a fair characterization.

[00:04:03] Speaker 04:
That was a district court's characterization of how thermodulation works.

[00:04:06] Speaker 04:
I'm not sure that was the correct characterization.

[00:04:10] Speaker 04:
And certainly, there's no expert testimony supporting the idea that a POSA would think that in a thermodulation process, water is getting out of the way.

[00:04:19] Speaker 04:
For example, HPMC is a powder.

[00:04:22] Speaker 04:
If it were just HPMC and heat, nothing would happen.

[00:04:25] Speaker 04:
So our position that our expert articulated based on the prior art and his own expertise is that water is playing a role.

[00:04:34] Speaker 03:
What is that role?

[00:04:34] Speaker 03:
When you say it's playing a role, it feels just a little too vague for me.

[00:04:38] Speaker 03:
What is it that it's doing?

[00:04:40] Speaker 04:
Well, as Dr. Bodemeyer explains, the water creates a structure around the hydrophobic regions of the HPMC, like a cage.

[00:04:48] Speaker 04:
And then when heat is applied, the water becomes disordered, and that causes the gelation.

[00:04:54] Speaker 03:
The cage breaks down.

[00:04:55] Speaker 04:
Yes, essentially.

[00:04:57] Speaker 03:
So then all the little particles can start binding together.

[00:05:01] Speaker 04:
Essentially, yes.

[00:05:03] Speaker 00:
But water doesn't also get bound in those particles, does it?

[00:05:09] Speaker 04:
Not in the heated portion, I don't believe it.

[00:05:11] Speaker 04:
I don't think it gets bound.

[00:05:13] Speaker 04:
It forms a cage around it.

[00:05:14] Speaker 00:
Water causes gelation to occur.

[00:05:17] Speaker 04:
The disorder of the breakdown of the cage.

[00:05:20] Speaker 00:
You said that no expert testified to the contrary.

[00:05:25] Speaker 00:
Mr. Tanjo testified that water is not a gelling agent and that he had never heard of water being used as a gelling agent.

[00:05:33] Speaker 04:
Mr. Tanjo is the inventor.

[00:05:35] Speaker 04:
He was not an expert.

[00:05:36] Speaker 00:
That's not my question.

[00:05:39] Speaker 00:
My question is, why shouldn't we, the court credited that testimony, why shouldn't we defer to the court's ruling on that?

[00:05:48] Speaker 04:
For a couple of reasons.

[00:05:49] Speaker 04:
First of all, the court overread what Mr. Tanjo actually said.

[00:05:55] Speaker 04:
Mr. Tanjo is the inventor.

[00:05:57] Speaker 04:
He was deposed as a fact witness to talk about the work that he did in the commercial embodiment, dulzikol.

[00:06:06] Speaker 04:
And most of the questions Teva relies on expressly related to the commercial embodiment.

[00:06:12] Speaker 04:
In other words, he was asked, you know, what is the gelling agent in your product?

[00:06:17] Speaker 04:
And he's, you know, carrageenan is that gelling agent.

[00:06:20] Speaker 04:
There was really only one, maybe two questions that even arguably were outside the context of the commercial embodiment.

[00:06:27] Speaker 04:
For example, at appendix 1272, page 234, he was asked if he had heard if water is a gelling agent, and he said no.

[00:06:38] Speaker 04:
But whether Mr. Tanjo had personally heard of water being used as a gelling agent doesn't address the question of what a poso would have thought.

[00:06:46] Speaker 04:
Mr. Tanjo made capsules for a living,

[00:06:49] Speaker 04:
He typically used Karageenan, and that was the example in the patent.

[00:06:54] Speaker 04:
So the testimony in question doesn't say what Teva and the district court thought it said.

[00:07:00] Speaker 04:
It simply didn't speak to the issue here.

[00:07:03] Speaker 04:
The second point, which we raise in our briefs, is the legal point.

[00:07:06] Speaker 04:
Cases such as Halmedica, where you have situations where the inventors have an idea what their claim scope is, which, as this court recognized in that opinion, may be different than what the claim scope actually is.

[00:07:19] Speaker 04:
And so courts do not typically fix claim scope based on inventor testimony.

[00:07:25] Speaker 04:
So it's not clear that the judge even relied on that testimony.

[00:07:30] Speaker 04:
He said that intrinsic evidence alone decided that gelling agents should exclude water.

[00:07:36] Speaker 04:
But to the extent he did, it was clearly erroneous.

[00:07:40] Speaker 01:
So the district court holds that a gelling agent is a substance that gels film.

[00:07:45] Speaker 01:
And the magistrate does, and the district court adopts it, and then just said there's no evidence in this record that would prevent subsummary judgment about whether or not water can be a gelling agent.

[00:08:01] Speaker 01:
Is that right?

[00:08:01] Speaker 01:
Am I understanding, remembering the facts right?

[00:08:04] Speaker 04:
Yes.

[00:08:04] Speaker 04:
The magistrate judge Payne's opinion, which the district judge adopted, had two holdings.

[00:08:10] Speaker 04:
It said, you lose because there's a negative limitation excluding water.

[00:08:15] Speaker 04:
And then he recognized that there may be an issue with that mode of analysis because he had looked at the accused product.

[00:08:22] Speaker 04:
So he went back and had an alternative holding saying, even without the negative limitation, you lose because there's no genuine issue of material fact.

[00:08:30] Speaker 01:
Well, you said that the issue of fact comes in, if I understand your argument right, from your expert who says that water contributes to gelling, right?

[00:08:46] Speaker 01:
If the gelling agent has to be a substance that gels the film composition, where is there evidence to prevent summary judgment in this case that water can meet that definition?

[00:08:57] Speaker 04:
We did have an infringement expert, Dr. Bodmeier, whose declaration starts at appendix 1278.

[00:09:04] Speaker 04:
And he relied on prior art discussing the thermogelation process, which is used in these capsules.

[00:09:10] Speaker 01:
And that testimony in particular appears at page 1293.

[00:09:14] Speaker 01:
And in paragraph 35, what he actually says is the term thermogelation refers to a well-known process by which water at elevated temperatures increases gelation.

[00:09:27] Speaker 01:
He doesn't say it is a substance that gels the film composition.

[00:09:31] Speaker 01:
OK, I see where the...

[00:09:33] Speaker 01:
increases gelation, so gelation is already theoretically occurring, right?

[00:09:38] Speaker 04:
Okay, so I can explain the confusion here.

[00:09:43] Speaker 04:
This is an excerpt of an expert report that we submitted in declaration form, and the preliminary construction that the district court gave us was a substance that increases gelation.

[00:09:54] Speaker 04:
They gave us that construction at the Markman hearing in August 2016.

[00:09:58] Speaker 04:
We didn't get the final Markman order

[00:10:01] Speaker 04:
until almost a year later.

[00:10:03] Speaker 04:
And in that one, he changed the construction to a substance that gels the film composition.

[00:10:09] Speaker 04:
But in that order, he said he didn't consider it to be substantively different than this preliminary construction.

[00:10:15] Speaker 04:
So that's why Dr. Bodemeyer refers to increasing gelation.

[00:10:20] Speaker 04:
But the judge told us that that was the same thing as substance that gels the film composition.

[00:10:27] Speaker 04:
And this is disgusted, I think, 1254.

[00:10:30] Speaker 04:
That's the court's final Markman order, or sorry, 1255.

[00:10:39] Speaker 04:
And so that's why the wording is different.

[00:10:48] Speaker 03:
None of those references that Dr. Bodemeyer relies on describes water as a gelling agent, right?

[00:10:56] Speaker 04:
They don't use the word.

[00:10:57] Speaker 04:
But they do describe it in terms of its role in the gelation process.

[00:11:01] Speaker 04:
It increases gelation.

[00:11:04] Speaker 04:
But that's correct.

[00:11:06] Speaker 04:
They don't say water is a gelling agent in so many words.

[00:11:13] Speaker 04:
I'd like to point up an issue that the court's understanding of the term substance that gels the film composition creates.

[00:11:25] Speaker 04:
gloss that it put on it in the summary judgment opinions is that it's not a gelling agent if the water plays a passive role versus an active role.

[00:11:37] Speaker 04:
That was what Judge Gilstrap said in denying our objections to the report and recommendation.

[00:11:43] Speaker 04:
But there's no intrinsic evidence and no expert testimony distinguishing between a gelling agent that plays an active role versus something that's not a gelling agent that plays a passive role.

[00:11:54] Speaker 04:
This is an example of judicial fact-finding and a claim construction that is not based on intrinsic evidence.

[00:12:02] Speaker 04:
The court's construction would also exclude preferred embodiments.

[00:12:06] Speaker 00:
For example... But the real issue here was not what's the role of water in the gelation process.

[00:12:13] Speaker 00:
That's not the issue.

[00:12:15] Speaker 00:
The issue is whether water is a gelling agent.

[00:12:18] Speaker 00:
So whether it plays a passive or minor role is irrelevant.

[00:12:23] Speaker 04:
Well, as we explained in, for example, our claim construction submissions, as with most substances in pharmaceutical formulations, you define the substance based on its role.

[00:12:35] Speaker 04:
For example, coloring agent, flavoring agent, gelling agent is no different.

[00:12:40] Speaker 04:
There are thousands of patents that use the term gelling agent.

[00:12:43] Speaker 00:
This patent, the specification, actually tells us what has a list of gelling agents.

[00:12:50] Speaker 04:
It has a list of examples.

[00:12:52] Speaker 00:
But it also says you can... Water is not one of them.

[00:12:56] Speaker 00:
I mean, I would think that if water was a gelling agent, that would be at the top of this list.

[00:13:02] Speaker 04:
I don't necessarily agree, Your Honor.

[00:13:04] Speaker 04:
I think the patent is indifferent to how you make the capsule.

[00:13:07] Speaker 04:
The focus of the patent, the invention here, was a custom HPMC grade that avoided certain problems in the prior art.

[00:13:15] Speaker 00:
Again, I'm not referring to how the process is undertaken.

[00:13:22] Speaker 00:
Question is whether water is a gelling agent.

[00:13:26] Speaker 00:
And the specification lists gelling agents, and water is not one of them.

[00:13:32] Speaker 04:
It is not listed as a gelling agent.

[00:13:34] Speaker 04:
It is not one of the examples.

[00:13:37] Speaker 04:
But I think the path.

[00:13:38] Speaker 01:
And in fact, water is discussed, what, like 28 times in the spec or something like that?

[00:13:42] Speaker 04:
Discussed 21 times.

[00:13:44] Speaker 01:
Never ever in the context of it being a gelling agent.

[00:13:47] Speaker 04:
That's correct.

[00:13:47] Speaker 04:
But I think this is another incorrect premise of the district court.

[00:13:51] Speaker 04:
is a district court thought that because it was mostly discussed as a solvent, saying water as a gelling agent would read out the gelling agent limitation, that's actually contrary to the record.

[00:14:03] Speaker 03:
What about the example at the bottom of column five, where the balance of your composition is water, which looks like it's about 80% water.

[00:14:17] Speaker 03:
It seems like you could have just

[00:14:20] Speaker 03:
said water, the gelling age, and then the cellulose without mentioning carmogaine or whatever you call it, caramegan, the so-called gelling agent.

[00:14:32] Speaker 03:
Well, it just said water.

[00:14:34] Speaker 03:
That's right.

[00:14:35] Speaker 03:
I mean, there's 80% water in this composition and none of it is

[00:14:41] Speaker 03:
playing the role of a gelling agent?

[00:14:42] Speaker 04:
Well, I think, first of all, this is the intermediate solution.

[00:14:45] Speaker 04:
So there's much less than 80% water in the final capsule.

[00:14:50] Speaker 04:
As with any gelling agent, the gelling agent is a residual component of the final hard capsule to which the claims are drawn.

[00:14:58] Speaker 04:
That's just as true of carrageenan as it is water.

[00:15:01] Speaker 04:
And I think Teva pointed out, well, this is 80% water.

[00:15:04] Speaker 04:
But in the final capsule, it's closer to 5%, which is within the preferred range.

[00:15:11] Speaker 04:
I don't know that this is really applicable, even aside from the fact that it's expressly an example.

[00:15:16] Speaker 04:
I don't think it's applicable to deciding whether something's a gelling agent.

[00:15:20] Speaker 04:
But this is a paradigmatic example of a patent that assumes that there will be background knowledge about what a gelling agent is and how to make capsules.

[00:15:30] Speaker 01:
Mr. Kennedy, we have almost exhausted all of your rebuttal time in addition to your regular time.

[00:15:34] Speaker 01:
So in order to reserve some rebuttal time, I'll restore some.

[00:15:38] Speaker 01:
Let's move on and have Mr. Rosendahl.

[00:15:40] Speaker 04:
Thank you, Your Honor.

[00:15:46] Speaker 02:
May it please the court?

[00:15:48] Speaker 02:
The problem created by Allergan's claim construction here is that it does have the effect of reading gelling agent and gelling aid out of the claims.

[00:15:59] Speaker 02:
The record is clear that there are some capsules that contain gelling agents and gelling aids because they're made with an additive gelation process.

[00:16:08] Speaker 02:
And then there are other capsules that don't contain gelling agents or gelling aids because they're made with a thermal gelation process.

[00:16:14] Speaker 02:
And I do think it may be helpful just to get some context to be clear about the differences between the two kinds of processes.

[00:16:21] Speaker 02:
An additive gelling process is very much like making jello at home in the refrigerator.

[00:16:26] Speaker 02:
One has a warm solution.

[00:16:28] Speaker 02:
One adds to it a gelling agent.

[00:16:30] Speaker 02:
And in the case of HPMC, one uses also a gelling aid to increase the effectiveness of the gelling agent.

[00:16:36] Speaker 02:
And then one cools down the solution, and the solution thickens and forms a gel.

[00:16:40] Speaker 02:
And then when that gel is dried into capsules, there will be residual gelling agents and gelling aids in those capsules.

[00:16:47] Speaker 02:
And indeed, the whole problem that the patent and suit is designed to solve arises uniquely in the context of additive gelling.

[00:16:54] Speaker 02:
Because what can happen is that the gelling aid, which is an ion like potassium or calcium, when the capsule dries and is stored over time, can precipitate out and form either a cloudy appearance on the capsule or form spots on the capsule.

[00:17:09] Speaker 02:
That's not a problem that arises in capsules made by thermogelation that don't have the gelling aid and the gelling agent in them.

[00:17:17] Speaker 02:
In thermogelation, instead of adding a gelling agent and cooling down the solution, one has a solution of just HPMC and water.

[00:17:25] Speaker 02:
One heats up the solution and takes advantage of the property of HPMC that it will form a gel on its own under the correct circumstances.

[00:17:35] Speaker 02:
I think that another error that we see here

[00:17:38] Speaker 02:
is that the argument made just now by Allergan was also the same argument made at sort of the core of Dr. Bodmeier's expert opinion, and it was found at page 1296 of the joint appendix in paragraph 39.

[00:17:52] Speaker 02:
He says, in the water HPMC solution, the water in the water HPMC solution increased the gelation of HPMC.

[00:17:59] Speaker 02:
And indeed, in this context, water is instrumental to HPMC gelation because dry powder HPMC on its own will not form a gel.

[00:18:08] Speaker 02:
So their argument is, it's certainly true that you can't get a gel just by heating up HPMC powder.

[00:18:14] Speaker 02:
But the mere fact that water is a solvent in the system, the mere fact that molecules move around more in solution than they do in solid form, doesn't mean that water is a gelling agent.

[00:18:27] Speaker 02:
Because of course, even in additive gelling, water is the solvent.

[00:18:30] Speaker 02:
You don't get a gel.

[00:18:31] Speaker 02:
If you take HPMC powder, you sprinkle it with carrageenan and potassium and heat it up or cool it off.

[00:18:36] Speaker 02:
you're also not going to get a gel.

[00:18:37] Speaker 02:
All of these solutions require water as a solvent, but the mere presence of water as a necessary condition for the reaction to go forward doesn't turn water into a gelling agent.

[00:18:51] Speaker 02:
In this regard, I think that the district court's fact finding that, as a matter of fact, persons of skill and the art would not understand water to be a gelling agent is an important one and one that cannot be overturned here unless the court were to find

[00:19:04] Speaker 02:
clear error, which the record would not support.

[00:19:07] Speaker 02:
Of particular interest, I think, Dr. McConville, who was Allergan's claim construction witness, said in his deposition that the 180 patent isn't about the thermal gelation of HPMC.

[00:19:19] Speaker 02:
The court will find that at appendix page 5521.

[00:19:22] Speaker 02:
The inventor of the patent in suit, Mr. Tangio, said that in 47 years in the industry, he had never heard of anyone referring to water as a gelling agent.

[00:19:35] Speaker 02:
There's evidence from the manufacturer of the accused capsules, the purpose of developing these capsules was to remove the gelling agent and gelling aid, that they were specifically made through a thermal gelling process in order not to have gelling agents and gelling aids present in them.

[00:19:56] Speaker 02:
So the evidence is extremely strong and indeed I think perhaps the most persuasive evidence is found in Allergan's own

[00:20:05] Speaker 02:
NDA, which was submitted to the FDA as part of this process of getting approval for its capsule formulation.

[00:20:14] Speaker 02:
The original proposed capsule was the one that is now being accused of infringement.

[00:20:20] Speaker 02:
And they then decided, when they made a decision to list this particular patent in the Orange Book, they changed the capsule from one that doesn't have a gelling agent and a gelling aid to one that does have a gelling agent and a gelling aid.

[00:20:33] Speaker 02:
And they told the FDA,

[00:20:35] Speaker 02:
And this can be found at appendix page 5437.

[00:20:37] Speaker 02:
It's also reproduced in our brief at pages 8 and 33.

[00:20:40] Speaker 02:
They told the FDA that the difference between what is now the accused capsule and the capsule that they are using is that theirs has a gelling agent and a gelling aid.

[00:20:51] Speaker 02:
They call it a gel processing aid.

[00:20:55] Speaker 02:
And that the accused capsule doesn't.

[00:20:57] Speaker 02:
So I think that there's overwhelming evidence in the record that the capsule that's at issue here

[00:21:04] Speaker 02:
doesn't have the gelling agent and the gelling aid that would be required for infringement.

[00:21:11] Speaker 02:
If the court has no further questions, I will yield the balance of my time.

[00:21:14] Speaker 01:
OK.

[00:21:14] Speaker 01:
You have two minutes.

[00:21:22] Speaker 04:
Just very briefly, Your Honor, I think Mr. Rosendahl's presentation is an example of what the district court did here in blending the claim construction and infringement inquiries.

[00:21:33] Speaker 04:
Mr. Rosendahl talked almost entirely about extrinsic evidence as supporting his understanding of the claims, but there's no intrinsic evidence justifying any departure from the plain meaning, particularly when column four of the patent says that you can use any manufacturing process you want.

[00:21:51] Speaker 04:
Now as for the extrinsic evidence that he cited, I already addressed the inventor testimony.

[00:21:57] Speaker 04:
The Delzical NDA at 5437 is a regulatory filing

[00:22:03] Speaker 04:
There's no reason in the record and no reason to think it attempted to catalog every possible use of every component.

[00:22:11] Speaker 04:
In fact, water is identified as a processing aid.

[00:22:14] Speaker 04:
The district court in Teva's theory is that water is a solvent in this product.

[00:22:18] Speaker 04:
And if you look at point two on that page, 5437, it talks about using carrageenan as a gelling agent in the capsules to ensure rapid dissolution.

[00:22:28] Speaker 04:
It's not clear it's even using it in the same context as capsule manufacturing.

[00:22:33] Speaker 04:
Dr. McConville's testimony would be probative if this were a product by process claim or if he weren't talking, he said it wasn't about thermodulation, but he also said right after that on the same page that heated water can gel a film composition.

[00:22:50] Speaker 04:
And finally, it's not surprising.

[00:22:52] Speaker 00:
What about the Sarkar article, the Sarkar article that mentions concerning thermodulation, but yet it doesn't say anything about water being a gelling agent?

[00:23:03] Speaker 04:
That's correct.

[00:23:05] Speaker 04:
They don't identify water as a gelling agent, but the articles also don't say that HPMC gels itself.

[00:23:11] Speaker 04:
The articles disclose, and Dr. Bodemeyer explains, that water is part of the process.

[00:23:18] Speaker 04:
And under the court's claim construction, at least without the negative limitation, being part of the gelation process should be enough to meet the claim limitation.

[00:23:26] Speaker 03:
Quick question.

[00:23:27] Speaker 03:
Sure.

[00:23:27] Speaker 03:
Is the generic already on the market?

[00:23:29] Speaker 04:
No.

[00:23:30] Speaker 04:
Teva's product has tentative approval.

[00:23:33] Speaker 03:
I mean, I'm just wondering, is this litigation holding up the marketing of the generic?

[00:23:39] Speaker 04:
I don't know.

[00:23:41] Speaker 04:
I mean, there is a first filer, so there's that issue as well.

[00:23:47] Speaker 04:
But the court's non-infringement ruling should be vacated and demanded for further proceed.

[00:23:52] Speaker 00:
Did the district court consider allegiance NDA in its decision?

[00:23:56] Speaker 04:
I believe so.

[00:23:59] Speaker 04:
Well, actually, I'm not sure.

[00:24:02] Speaker 04:
Well, it really just said Dr. Bodemeyer's opinions were conclusory, which clearly is not the case.

[00:24:10] Speaker 04:
It was a very different case than, for example, Novartis, where this court found conclusory an expert which had a computer model with no assumptions behind it.

[00:24:18] Speaker 04:
The fact finder may disagree with Dr. Bodemeyer's analysis, but the basis for the analysis is all there, and it simply can't be disregarded on summary judgment.

[00:24:29] Speaker 01:
I thank both counsels.

[00:24:30] Speaker 01:
This case is taken under submission.