[00:00:00] Speaker 01:
Last case for argument this morning is 161785, Shire Development versus Watson Pharmaceuticals.

[00:00:38] Speaker 01:
Okay, Mr. Maddox, whenever you're ready.

[00:00:41] Speaker 00:
Yes, I may please the Court.

[00:00:43] Speaker 00:
This is the second time we've been before you in this litigation.

[00:00:47] Speaker 00:
The first time this Court vacated the judgment of infringement on the theory that the magnesium stearate lubricant found in Watson's granules constituted an interlipophilic matrix of the claim based on a claim construction that lipophilic matrix meant any matrix including at least one lipophilic excipient.

[00:01:08] Speaker 00:
And you wrote that was the wrong claim construction.

[00:01:12] Speaker 00:
And you vacated and sent it back down with instructions to try again.

[00:01:19] Speaker 00:
In your opinion?

[00:01:21] Speaker 02:
Well, that's not entirely accurate.

[00:01:23] Speaker 02:
We vacated and remanded with the direction to apply a specific claim construction that we adopted.

[00:01:30] Speaker 00:
Yes.

[00:01:31] Speaker 00:
Which had certain characteristics, yes.

[00:01:35] Speaker 00:
In the opinion, you wrote,

[00:01:38] Speaker 00:
A matrix comprised of only one lipophilic substance and several hydrophilic substances and thus capable of exhibiting hydrophilic properties would meet the district court's construction of lipophilic matrix and such a result contradicts the customary and ordinary meaning of lipophilic and hydrophilic.

[00:01:56] Speaker 00:
And that is the short answer to why you should reverse here.

[00:02:00] Speaker 00:
It is undisputed that the alleged granule lipophilic matrix here

[00:02:06] Speaker 00:
is comprised of only one lipophilic.

[00:02:09] Speaker 04:
Suppose I read that sentence, as I think I'm pretty strongly inclined to do, to say that that sentence said, under the district court's claim construction, which said even a small component of the matrix, if that's lipophilic, that's enough, that the sentence that you quoted from the opinion said would automatically meet it.

[00:02:30] Speaker 04:
And you said, no, that can't be right.

[00:02:32] Speaker 04:
That leaves the question whether the full matrix

[00:02:36] Speaker 04:
Has lipophilic characteristics and I don't read that sentence to say just because there are hydrophilic components of it that that can't be true So it's a factual question Okay, as you know, it is undisputed facts that 95% so what why is this not it?

[00:02:52] Speaker 04:
It's not a numbers game.

[00:02:53] Speaker 04:
The question is what the proof is that the matrix as a whole Okay, so we would go to the guidance from your opinion

[00:03:04] Speaker 00:
This court said, look, the matrix that is deemed lipophilic matrix cannot have hydrophilic properties.

[00:03:09] Speaker 02:
That's not what it said.

[00:03:10] Speaker 02:
I mean, it means that the matrix has to act in a lipophilic manner, not in a hydrophilic manner.

[00:03:18] Speaker 02:
Right.

[00:03:18] Speaker 02:
That's what we said.

[00:03:19] Speaker 02:
And the district court, as far as I can tell, took that definition, looked at the facts, and said, even though there are a large number of hydrophilic elements here, the matrix as a whole operates in a lipophilic manner.

[00:03:34] Speaker 02:
and he cites to expert testimony and the like to reach that conclusion.

[00:03:39] Speaker 02:
How can we disturb that factual finding when it's based upon facts that he found?

[00:03:45] Speaker 00:
Right.

[00:03:45] Speaker 00:
It's based on facts that he found and a new definition of hydrophilic that he created.

[00:03:51] Speaker 00:
His definition of hydrophilic properties are limited to swelling when in contact with water.

[00:03:58] Speaker 00:
He applied

[00:03:59] Speaker 00:
a new definition of hydrophilic.

[00:04:00] Speaker 02:
I don't understand why you're concentrating on hydrophilic, though, because what he needs to look at is whether the matrix is lipophilic.

[00:04:09] Speaker 02:
And there is evidence and testimony and the like that he looked at to rely on and conclude that it was a lipophilic matrix.

[00:04:18] Speaker 02:
Isn't that enough to sustain that factual finding?

[00:04:20] Speaker 00:
No, because he changed the definition of lipophilic, too.

[00:04:24] Speaker 00:
It wasn't having poor affinity to aqueous fluids.

[00:04:27] Speaker 00:
The definition he used was

[00:04:29] Speaker 00:
having any relative resistance to water.

[00:04:32] Speaker 00:
And Shire's own expert, Dr. Yang, who performed the test upon which the court relied, admitted that his testing doesn't allow you to conclude something is lipophilic.

[00:04:42] Speaker 00:
And briefly what his testing was was he put a drop of water on the granule and a drop of water on the space between the granules, essentially.

[00:04:53] Speaker 00:
And both drops of water were absorbed in less than a second.

[00:04:57] Speaker 00:
And so we said,

[00:04:59] Speaker 00:
Well, Dr. Yang, can you conclude from this that the granules are lipophilic?

[00:05:09] Speaker 00:
And he admitted that he could not, because it's not any evidence of what the granules were like in terms of rate of absorption as compared to average excipients.

[00:05:20] Speaker 00:
The judge basically adopted Shire's redefinition of hydrophilic and lipophilic.

[00:05:25] Speaker 00:
They created a relative definition of lipophilic,

[00:05:28] Speaker 00:
to mean, well, it absorbs water slower than the space next to it.

[00:05:34] Speaker 00:
Both, and their experts admit this, both showed affinity to water.

[00:05:39] Speaker 00:
Both absorbed it in less than a second.

[00:05:43] Speaker 00:
So that's why we feel that was wrong.

[00:05:46] Speaker 00:
We also have the judge, he made up a new definition of main component.

[00:05:52] Speaker 00:
He took your decision saying, listen, the 728 patent teaches that this occurs, which is the

[00:05:57] Speaker 00:
function of the lipophilic matrix when the main component of the matrix is lipophilic.

[00:06:02] Speaker 00:
And we said, OK, well, let's look at your lipophilic matrix.

[00:06:05] Speaker 00:
It's a granule.

[00:06:07] Speaker 00:
95% of it is hydrophilic excipients.

[00:06:10] Speaker 00:
Some unknown amount, less than 5%, is lipophilic.

[00:06:14] Speaker 00:
How is that the main component of this structure?

[00:06:17] Speaker 00:
It's a structural claim.

[00:06:19] Speaker 00:
And he came up with the definition of main component to be, well, we only consider the part of it

[00:06:27] Speaker 00:
that is responsible for lipophilic properties.

[00:06:29] Speaker 00:
That's the main component.

[00:06:31] Speaker 00:
In a structural claim to say the main component of this structure is only that within it which has a particular property is an error.

[00:06:40] Speaker 04:
Where did we say in the prior decision that there was a main component analysis separate and apart from the factual question whether the matrix as a whole has lipophilic

[00:06:56] Speaker 04:
characteristics.

[00:06:57] Speaker 00:
I'm referring here to the decision at 1365 and 6.

[00:07:02] Speaker 00:
There's a sentence in particular at the end.

[00:07:05] Speaker 00:
It says, the 728 patent teaches that this, which is what I was referring to, occurs when the main component of the matrix structure is lipophilic.

[00:07:13] Speaker 00:
And so we went looking for what's the main component.

[00:07:17] Speaker 04:
OK.

[00:07:18] Speaker 04:
Can I ask you to do I understand right that

[00:07:26] Speaker 04:
Even if we thought that the district court had an adequate basis for the factual findings about lipophilic characteristics and hydrophobic, hydrophilic characteristics, that you have a separate argument that the consisting of consisting of, the double consisting of claim language just absolutely cannot be met here.

[00:07:55] Speaker 00:
That's right.

[00:07:56] Speaker 00:
And there are two arguments, and that's the second one.

[00:08:00] Speaker 00:
And that's not really a question of interpreting your prior decision.

[00:08:02] Speaker 00:
That's a question of the law of consisting of.

[00:08:05] Speaker 00:
And we have here, the claim language we've got is an interlipophilic matrix consisting of substances selected from the group consisting of on saturated.

[00:08:17] Speaker 00:
And it goes down the list of substances.

[00:08:20] Speaker 04:
Right.

[00:08:20] Speaker 04:
That's what I meant by the double consisting of.

[00:08:22] Speaker 00:
And this is actually, you cited it in your recent dissent in the multi-layer case as an example of what you call double consisting of, that there's no question that it doesn't really leave any doubt as to it being closed.

[00:08:37] Speaker 00:
The important thing here is that the first consisting of, it's the matrix consisting of substances, not the matrix consisting of lipophilic substances, just substances.

[00:08:51] Speaker 00:
and then selected from and so forth and so on.

[00:08:54] Speaker 00:
Frankly, if it said consisting of lipophilic substances, we might have a different case here.

[00:09:01] Speaker 00:
But here the claim is saying, listen, this structure, the matrix, consisting of substances selected from the group consisting of and going on and on and on.

[00:09:11] Speaker 04:
Right.

[00:09:11] Speaker 04:
And do I understand?

[00:09:12] Speaker 04:
I mean, your argument is that in the accused products, just focusing on the lipophilic matrix, you have, I think,

[00:09:20] Speaker 04:
counterpart argument for the other one, also, for this one.

[00:09:24] Speaker 04:
It, in fact, and undisputably, includes things not in the group listed.

[00:09:32] Speaker 04:
Not in the Marquise group.

[00:09:34] Speaker 04:
And they are things that you, in fact, here, as a matter of law, have to count, because they are not unrelated.

[00:09:42] Speaker 04:
Right.

[00:09:42] Speaker 04:
Sort of QED.

[00:09:44] Speaker 02:
Yes.

[00:09:47] Speaker 02:
So even if the matrix, if we agree with the district court that the matrix acts as a lipophilic matrix, that the claim construction is correct and the like, there's still no infringement because it doesn't meet the Marcuse group claim.

[00:10:04] Speaker 00:
Right, because the claim is not to any lipophilic matrix.

[00:10:08] Speaker 00:
It's to a particular universe of lipophilic matrices, the substances in which are limited to this group.

[00:10:16] Speaker 00:
And yes, there are

[00:10:17] Speaker 00:
four other substances according to the proof submitted by Shire in our granule.

[00:10:23] Speaker 00:
These four other substances are something north of 95% of the structure.

[00:10:27] Speaker 00:
So it's not a question of some tiny bit, some trace amount got in there and someone's trying to get out of it on that ground.

[00:10:35] Speaker 00:
These are substances that were part of the manufacturing, they're in fact the vast majority of the structure.

[00:10:42] Speaker 00:
Yes, that's our position.

[00:10:45] Speaker 00:
I'm going to reserve the rest for a rattle, if I may.

[00:10:47] Speaker 01:
Thank you.

[00:10:55] Speaker 03:
Good afternoon.

[00:10:56] Speaker 03:
May it please the court, Edgar Haug for the Epeli Shire et al.

[00:11:03] Speaker 03:
Can you start where we just left off?

[00:11:05] Speaker 03:
With consisting of?

[00:11:06] Speaker 03:
Yeah, the double consisting of.

[00:11:08] Speaker 03:
Double of, yes we can.

[00:11:10] Speaker 03:
I don't think there's any debate, Your Honor, as to what consisting of means in this case.

[00:11:15] Speaker 03:
There's a claim construction of, consisting of, which was part of the original claim construction from the court.

[00:11:22] Speaker 03:
Where is that?

[00:11:29] Speaker 03:
This would be specifically Appendix 2195.

[00:11:35] Speaker 03:
This is now the claim construction order from Judge Middlebrooks, actually before the first appeal.

[00:11:43] Speaker 03:
And this was not appealed.

[00:11:44] Speaker 03:
And the claim construction reads, an exclusionary term specifying that an element contains only what is expressly set forth in a recited list, but does not exclude substances unrelated to or outside of the context of said element.

[00:12:00] Speaker 03:
There's no dispute about that claim construction was not appealed.

[00:12:03] Speaker 04:
And that's the standard law, even if it hadn't been here.

[00:12:06] Speaker 03:
That's what we would say.

[00:12:08] Speaker 03:
And indeed, in the trial after remand, Judge Middlebrooks

[00:12:12] Speaker 03:
did his analysis, as your honors are well aware, from the opinion, and towards the end of the opinion he says, I want to take up an argument raised by Watson, which is this consisting of argument, and he carefully sets forth what the argument is, and then he goes on to say how he made fact findings, that whatever is in that volume, the inner granule volume in this case, whatever is in there is unrelated within the scope of the

[00:12:41] Speaker 03:
claim construction for the consisting of language.

[00:12:44] Speaker 03:
So the hydrophilic excipients that were found inside the granule, he found to be unrelated to the lipophilic characteristic.

[00:12:52] Speaker 03:
And what was the reason he gave?

[00:12:53] Speaker 03:
He gave the reasons that they did not prevent in any way the inner lipophilic matrix from having a lipophilic characteristic.

[00:13:03] Speaker 04:
Right, so that's, I guess, what stopped me short.

[00:13:06] Speaker 04:
It seems to me that as a matter of

[00:13:09] Speaker 04:
law, and you can tell me why you think I'm wrong about this, that that cannot be, at least in this claim, and maybe even more generally, enough to say it's unrelated.

[00:13:20] Speaker 04:
Independently of the consisting of language, the matrix still has to be lipo-philic.

[00:13:26] Speaker 04:
So you've now just read out of any significance in the claim consisting, the consisting of, consisting of.

[00:13:33] Speaker 04:
It still has to be lipo-philic, and under the district courts,

[00:13:38] Speaker 04:
rationale, which you just stated, as long as the net result was still lipophilic, then everything else that would be in it doesn't matter.

[00:13:48] Speaker 04:
Another way to look at it is that's a way of saying exactly what the claim would mean if it said consisting essentially of, consisting essentially meaning no material change in the properties that these things are supposed to be performed, which would also be either be essentially contrary to the language

[00:14:06] Speaker 04:
neutralizing any meaning of the actual choice consisting of consisting of.

[00:14:12] Speaker 04:
So I don't understand how the rationale given can satisfy the narrow category of unrelated to.

[00:14:21] Speaker 03:
First of all the judge, the court set forth the findings of fact I believe in pages 28 to 30 in the opinion and made specific findings of fact for example that the magnesium stearate is the main component

[00:14:34] Speaker 03:
in the inner volume of the granules.

[00:14:38] Speaker 03:
The other hydrophilic excipients including sodium starch glycolate are unrelated to the function of the inner lipophilic matrix.

[00:14:47] Speaker 03:
And then he goes on to talk about the purpose of the inner lipophilic matrix is to contribute to the controlled release of mesalamine.

[00:14:54] Speaker 03:
He made fact findings that these other hydrophilic excipients do not control the release of mesalamine within the granule.

[00:15:02] Speaker 03:
All kinds of fact findings to that effect.

[00:15:04] Speaker 03:
So I don't think we're reading out that claim at all.

[00:15:08] Speaker 03:
I also want to make the point that, and this is a point of, I think, confusion maybe throughout these cases.

[00:15:16] Speaker 03:
The interolypophilic matrix is a distribution of magnesium stearate in the Watson product.

[00:15:24] Speaker 03:
That is the structure.

[00:15:26] Speaker 03:
The claim construction for matrix is a macroscopically homogeneous structure in all its volume.

[00:15:33] Speaker 03:
That structure is the distribution of magnesium stearate.

[00:15:38] Speaker 03:
The volume is the volume within the granule in the Watson product.

[00:15:44] Speaker 03:
And I think what's happening here is there's sometimes people look at the volume and say that's the matrix, but it really isn't.

[00:15:52] Speaker 03:
The matrix is what I said.

[00:15:53] Speaker 03:
It's the distribution of magnesium stearate.

[00:15:56] Speaker 03:
And on page 17 of the opinion,

[00:15:59] Speaker 03:
Judge Middlebrook specifically found.

[00:16:01] Speaker 04:
You used the word confusion, and I'm going to ask a question that will maybe betray some of that confusion.

[00:16:08] Speaker 04:
Did you just say something that is exactly the claim construction argument that we reversed last time?

[00:16:15] Speaker 04:
Don't just look at the component?

[00:16:19] Speaker 04:
No.

[00:16:20] Speaker 04:
So why is it different, what you just said different?

[00:16:22] Speaker 03:
Well, what's different is the claim construction that was reversed.

[00:16:26] Speaker 03:
was that all you have to do is find a lipophilic excipient in what you identify to be the matrix, and then that's enough.

[00:16:33] Speaker 03:
And that was reversed by this court for sound reasons.

[00:16:36] Speaker 03:
It went back, and it's clear that the judge took that up on remand and said, I have to go further, and I have to find that that matrix has a lipophilic characteristic and is separate from the outer hydrophilic matrix, which has to have a hydrophilic characteristic.

[00:16:53] Speaker 03:
That's what Judge Middlebrooks did.

[00:16:54] Speaker 03:
That's what the whole trial was about.

[00:16:56] Speaker 03:
He found as a finding of fact, it's on page 17, magnesium stearate in the granules forms a macroscopically homogeneous structure in all its volume.

[00:17:07] Speaker 03:
It's a fact finding was not appealed.

[00:17:09] Speaker 03:
And he does the same thing with sodium starch glycolate as to being hydrophilic in the extragranular volume.

[00:17:17] Speaker 03:
Now that wasn't appealed either.

[00:17:18] Speaker 03:
So those are findings of fact as to what the matrix actually is.

[00:17:22] Speaker 04:
Can you give me a citation so I can look at it?

[00:17:24] Speaker 03:
Sure, that would be page 17.

[00:17:26] Speaker 03:
of the opinion.

[00:17:30] Speaker 03:
That's Appendix 19?

[00:17:32] Speaker 03:
Yes.

[00:17:33] Speaker 03:
OK.

[00:17:33] Speaker 03:
Appendix 19.

[00:17:35] Speaker 03:
So anyway, he made those fact findings.

[00:17:37] Speaker 03:
But he then went further, a macroscopically homogeneous structure in all its volume.

[00:17:43] Speaker 03:
So you have to know what the volume is that you're talking about, right?

[00:17:46] Speaker 03:
The structure here is the magnesium stearate distribution within the granule, the granule, which is a volume.

[00:17:54] Speaker 03:
And now we're looking at the volume.

[00:17:56] Speaker 03:
If you say the matrix is what I think it is, the magnesium stearate distribution.

[00:18:02] Speaker 02:
So the matrix is not the granule.

[00:18:03] Speaker 02:
It's just the magnesium stearate.

[00:18:06] Speaker 03:
Correct, Your Honor.

[00:18:07] Speaker 03:
And if that is what the matrix is found to be.

[00:18:10] Speaker 02:
Sounds an awful lot like what you argued to us last time that we didn't agree with.

[00:18:16] Speaker 03:
No.

[00:18:16] Speaker 03:
I think the claim construction here is that you can't just stop and say that's the matrix.

[00:18:21] Speaker 02:
I think the district court actually looked at this and decided under our new claim construction

[00:18:26] Speaker 02:
that the granule was the lipophilic matrix.

[00:18:30] Speaker 03:
He looked at the volume, yes.

[00:18:31] Speaker 03:
And he found that that had exhibited a lipophilic characteristic.

[00:18:35] Speaker 02:
But if we're looking at the granule as the matrix, not just the magnesium steroid within the granule, then the granule itself contains both the magnesium steroid as well as all these other hydrophilic elements.

[00:18:49] Speaker 02:
Correct.

[00:18:49] Speaker 02:
And then that's when we get to the Marcuse group question.

[00:18:51] Speaker 03:
Exactly right.

[00:18:52] Speaker 03:
And the court did exactly that and addressed that issue.

[00:18:56] Speaker 02:
Yes, and he?

[00:18:57] Speaker 02:
That seems to me to be a extraordinary definition of unrelated to, as defined by our precedent.

[00:19:05] Speaker 02:
I mean, can you think of any other case where we've described unrelated to as a chemical element that acts in a different way than the Marcouche group itself, rather than like the spatula case in the chemical context, where you have a spatula in chemicals that's unrelated?

[00:19:25] Speaker 02:
Or you have alcohol added for a purpose of basically getting a lower tax rate that has nothing to do with the operation.

[00:19:34] Speaker 02:
I don't understand chemically how these hydrophilic elements don't have some relationship to whether this is lipophilic or hydrophilic.

[00:19:42] Speaker 03:
Well, that's exactly what the facts showed in the case.

[00:19:44] Speaker 03:
That's what the experts did through their testing.

[00:19:47] Speaker 03:
That's what they did through their analysis of the testing.

[00:19:49] Speaker 02:
No, but that's whether it acts lipophilically.

[00:19:51] Speaker 02:
But it seems like you're reading out these Marcuse group limitations at all.

[00:19:56] Speaker 02:
If the Marcuse group is really just the ingredient we say acting for its purpose, it can include any other number of ingredients whatsoever.

[00:20:05] Speaker 02:
Have we ever defined Marcuse group that broadly?

[00:20:08] Speaker 03:
I put that way.

[00:20:09] Speaker 03:
I don't believe so.

[00:20:10] Speaker 03:
I think, though, the law in this consisting of area always comes down on case by case.

[00:20:16] Speaker 03:
You have to look at each patent.

[00:20:18] Speaker 03:
I don't think you can draw these

[00:20:20] Speaker 03:
general distinctions as to what would or wouldn't be related, the case law, the Norian case followed by the Conoco case say, if it's unrelated, that is an exception to the consistent language.

[00:20:32] Speaker 02:
And that's the evidence.

[00:20:33] Speaker 02:
By no means a chemistry expert.

[00:20:36] Speaker 02:
And so this stuff is a struggle.

[00:20:38] Speaker 02:
But suppose you had a Marcouche group that said it consists of acidic elements drawn from X group, and it

[00:20:49] Speaker 02:
the actual composition had those elements, which drove the purpose of having acidic elements, but also had, for some reason, alkaline elements in there as well, which I, at least from my, you know, rudimentary high school chemistry suggests that they're opposite.

[00:21:06] Speaker 02:
Wouldn't that violate the Marcouche group there?

[00:21:08] Speaker 03:
Not necessarily.

[00:21:08] Speaker 03:
I think it's a factual question as to whether or not the presence of those alkaline chemicals are related or unrelated to

[00:21:16] Speaker 03:
the claimed invention.

[00:21:17] Speaker 03:
That is the factual inquiry.

[00:21:19] Speaker 03:
That's the import of the Noreen Conoco cases.

[00:21:22] Speaker 03:
It's a question of fact.

[00:21:23] Speaker 03:
For the court to ignore that finding of fact, there's a series of findings of fact by Judge Middlebrooks on this point, on this very point, none of which have been appealed, by the way, in this appeal.

[00:21:36] Speaker 03:
There is no appeal here that any factual finding is clearly erroneous.

[00:21:41] Speaker 03:
So with all due respect, the court found

[00:21:45] Speaker 03:
that they were unrelated in a trial.

[00:21:49] Speaker 03:
On appeal, the defendant, or in this case, Watson, did not appeal that finding a fact.

[00:21:56] Speaker 03:
And if it were the way your honor might be suggesting that we've never had a case like this, well, maybe it would have been a good thing for them to appeal and raise it that way.

[00:22:04] Speaker 03:
But they didn't.

[00:22:04] Speaker 03:
They accepted that fact finding.

[00:22:06] Speaker 02:
Well, I assume they're appealing it because they think the district court's legal interpretation, the Mark Cush group, and the unrelated exception

[00:22:14] Speaker 02:
is legally incorrect, that unrelated can't extend so far as to any element whatsoever that doesn't contribute to the operation of the claim.

[00:22:26] Speaker 03:
I don't believe that's in the appeal.

[00:22:27] Speaker 03:
I think if you go through the summary of the argument in the appellant's brief, they say a lot of things about what Judge Middlebrooks did.

[00:22:34] Speaker 03:
They use very strong language, like he attempted to work around this court's claim construction.

[00:22:41] Speaker 03:
He defied the court's claim construction.

[00:22:43] Speaker 03:
He violated it.

[00:22:44] Speaker 03:
It's a very, very strong brief in saying what Judge Middlebrooks apparently, in their view, did.

[00:22:50] Speaker 03:
He did none of those things.

[00:22:51] Speaker 03:
He followed the claim construction from this court.

[00:22:53] Speaker 03:
I was referring now to pages 27, 28, and 29 in their principal brief.

[00:22:59] Speaker 03:
He followed this little court's claim construction to the nines.

[00:23:03] Speaker 03:
And he showed how he did it.

[00:23:04] Speaker 04:
And he made fact findings.

[00:23:06] Speaker 04:
Can I just return to, I guess, a variant of the question that I asked you at the beginning of this?

[00:23:14] Speaker 04:
What work is being done by consisting of, consisting of, under your and Judge Middlebrook's argument determination that as long as the net result is lipophilic, then anything else that's in there just doesn't matter?

[00:23:34] Speaker 03:
Well, that's not the claim construction, right?

[00:23:35] Speaker 03:
What you just said is not the claim construction.

[00:23:37] Speaker 03:
We never thought it was, and we haven't advocated that.

[00:23:40] Speaker 03:
What it does, consisting of an inner lipophilic matrix,

[00:23:43] Speaker 03:
consisting of modifies matrix, not volume, by the way, but it modifies matrix.

[00:23:50] Speaker 04:
I'm sorry, let's assume that the granule is the matrix.

[00:23:53] Speaker 03:
Okay, so an interlipophilic matrix consisting of, and then there are... Of substances from a group consisting of it.

[00:24:01] Speaker 03:
Then there are many, many other lipophilic excipients in the universe that are not in that small group.

[00:24:10] Speaker 03:
So they are all excluded.

[00:24:12] Speaker 03:
You could not have another lipophilic excipient in the matrix without violating consisting of in that claim.

[00:24:21] Speaker 03:
So that is what it's carving out.

[00:24:23] Speaker 03:
If this were an invalidity case.

[00:24:24] Speaker 04:
So it's carving out only unlisted lipophilic components, not carving out all the hydrophilic components?

[00:24:34] Speaker 03:
I think it's carving out anything that

[00:24:36] Speaker 03:
makes up the matrix in the way it's been construed by this court, which is a matrix which has a lipophilic characteristic.

[00:24:44] Speaker 03:
And the hydrophilic excipients that are in that volume, if you find that to be the matrix, they do not do anything to create a lipophilic matrix.

[00:24:55] Speaker 03:
That is the evidence.

[00:24:56] Speaker 03:
That is the factual evidence.

[00:24:57] Speaker 03:
And therefore, if that's the claim construction, or I should say the interpretation, then I think we are back to

[00:25:04] Speaker 03:
Are they unrelated to the invention or not?

[00:25:06] Speaker 04:
Right, so I don't understand, I guess, I still don't understand on that argument how this would be any different if this had said an interlipophilic matrix comprising substances from the group selected from these listed items and anything else.

[00:25:26] Speaker 04:
Because at the end of the day, as long as anything else would still be covered, as long as at the end of the day,

[00:25:33] Speaker 04:
the granule was still lipophilic.

[00:25:35] Speaker 03:
I'm not saying anything else would be covered.

[00:25:36] Speaker 03:
I think in that scenario, if you had comprising of, it's an open-ended claim.

[00:25:40] Speaker 03:
You could have other lipophilic excipients outside that group.

[00:25:43] Speaker 03:
You could have other hydrophilic excipients or 1C.

[00:25:48] Speaker 03:
You could have other things in there, and the comprising would not be a bar.

[00:25:53] Speaker 03:
So it's not at all analogous to that, in my view.

[00:25:58] Speaker 03:
But again, I want to emphasize

[00:26:04] Speaker 03:
The court followed this court's claim construction very, very carefully.

[00:26:07] Speaker 03:
It's all set forth in the opinion in the second trial and made fact findings when it had to make fact findings to determine what the matrices were, to determine whether or not there was a lipophilic characteristic or a hydrophilic characteristic, to determine if they were separate, and also to determine if Watson's view of how you should look at the volume of the granule is correct.

[00:26:30] Speaker 03:
He went further and said,

[00:26:32] Speaker 03:
That which is in that granule, which is not lipophilic excipient, is unrelated to the invention.

[00:26:37] Speaker 03:
And that is my finding of fact.

[00:26:39] Speaker 03:
And that finding of fact was not appealed.

[00:26:42] Speaker 03:
Thank you.

[00:26:48] Speaker 00:
The most fundamental problem with what my friend Mr. Howe just said is that he's citing to you findings of fact here as if they can trump the law, the law consisting of

[00:27:00] Speaker 00:
especially when there's no ambiguity.

[00:27:01] Speaker 01:
Well, the question is whether or not relatedness is a question of fact or a question of law or unrelated.

[00:27:06] Speaker 01:
Right.

[00:27:07] Speaker 01:
Right.

[00:27:07] Speaker 01:
And are you maintaining that it's a question of law and not a question of fact?

[00:27:10] Speaker 01:
Yes.

[00:27:13] Speaker 00:
Because otherwise, unrelated could mean anything.

[00:27:16] Speaker 00:
It has to have some actual – it's an exception.

[00:27:21] Speaker 00:
It's been recognized as a narrow exception.

[00:27:23] Speaker 00:
We know that a spatula in a chemical kit

[00:27:26] Speaker 00:
is unrelated.

[00:27:27] Speaker 00:
We have nothing like that here.

[00:27:28] Speaker 00:
We have a claim that is a structural claim.

[00:27:31] Speaker 01:
Well, have we said anything in our precedent that defines what unrelated is?

[00:27:35] Speaker 01:
I mean, we've all got the example of the spatula case, but... Yeah.

[00:27:39] Speaker 00:
I think there's a reference in Norian to that the spatula doesn't interact with the other parts of the kit.

[00:27:47] Speaker 00:
Here, the excipients that make up 95 percent of the alleged granule of the alleged matrix

[00:27:54] Speaker 00:
plainly interact with physically and chemically.

[00:27:58] Speaker 00:
No one is saying it doesn't.

[00:28:00] Speaker 00:
All we're saying is the judge found some evidence that accepted that net-net he thinks this is relatively lipophilic compared to the spaces between the granules.

[00:28:14] Speaker 04:
What do you do with 1C, optionally other excipients?

[00:28:19] Speaker 04:
How does that

[00:28:22] Speaker 04:
interact with, relate to, connect with the closed nature of the Marcoosh groups in 1A and 1B?

[00:28:30] Speaker 00:
Sure.

[00:28:30] Speaker 00:
A couple things.

[00:28:31] Speaker 00:
First of all, neither of us argued about that.

[00:28:33] Speaker 00:
That was something the judge came up with on his own, so no one had a chance to say anything about it.

[00:28:38] Speaker 00:
It was a closing argument.

[00:28:40] Speaker 00:
Well, you have three minutes here.

[00:28:41] Speaker 00:
Here's your chance.

[00:28:42] Speaker 00:
But fundamentally, if you look at the claim, it's a comprising claim.

[00:28:46] Speaker 00:
One, a controlled release oral pharmaceutical composition

[00:28:51] Speaker 00:
containing the dot with comprising, and then it has A, B, and C. So there has to be an interlipophilic matrix in it.

[00:28:57] Speaker 00:
That's A. There has to be an outer hydrophilic matrix in it, and however they're restricted.

[00:29:02] Speaker 00:
And C, the overall product can have other excipients.

[00:29:06] Speaker 04:
So 1C refers only to stuff outside the matrices.

[00:29:11] Speaker 00:
Right.

[00:29:11] Speaker 04:
Outside the Markovsh... Each matrix is closed in its composition, but outside the matrices, there can be other stuff.

[00:29:20] Speaker 00:
That's how I read it, given the structure of the claim, yes.

[00:29:26] Speaker 00:
Finally, we say that you are right.

[00:29:29] Speaker 00:
Whenever things get difficult in the granules, given all the other stuff that's in there, we start hearing, well, it's really this magnesium stearate that's in the granules.

[00:29:41] Speaker 00:
That's really the, we designate that as the matrix.

[00:29:44] Speaker 00:
And this is exactly what you heard last time.

[00:29:47] Speaker 00:
And the references in the record are appendix 7211.

[00:29:51] Speaker 00:
7212, appendix 2167.

[00:29:54] Speaker 00:
You can see that that is exactly what you dealt with last time, what you were presented with last time, and what you rejected last time.

[00:30:03] Speaker 00:
If you have no further questions.

[00:30:05] Speaker 01:
Thank you.

[00:30:06] Speaker 01:
We thank both parties and the cases submitted.