[00:00:00] Speaker 02:
The first case for argument this morning is 17-1895 record versus R.O.

[00:00:07] Speaker 02:
Bean and Doe.

[00:00:09] Speaker 02:
Mr. Nash.

[00:00:11] Speaker 00:
Thank you, Your Honor.

[00:00:12] Speaker 00:
May it please the Court.

[00:00:14] Speaker 00:
The District Court in this case committed error when it rewrote the claims in this case to require distinct formulations.

[00:00:26] Speaker 00:
for example, claim one in the 03-2 patent.

[00:00:31] Speaker 02:
Well, that particular claim talks about two portions, the first portion and the second portion.

[00:00:37] Speaker 02:
So how, in your view, or why did this court rewrite those claims, given what the claims say?

[00:00:45] Speaker 00:
Well, the term portion in the ordinary sense of the word, in its ordinary and customary meaning, is a part of a whole, whether it's integrated in it or separated from it.

[00:00:55] Speaker 00:
There's no

[00:00:56] Speaker 00:
distinctness required in the plain and ordinary meaning of the term portion.

[00:01:03] Speaker 00:
That plus the addition of the word formulation, which does not appear anywhere in claim one of the 032 patent, which the district court, when it applied the word formulation, seemed to impart a meaning separate ingredient lists, which the claim doesn't say anything at all about separate ingredient lists.

[00:01:22] Speaker 00:
The plain and ordinary meaning simply requires

[00:01:25] Speaker 00:
two portions, and then it defines those portions by what they do.

[00:01:32] Speaker 00:
The first portion is an immediate release form, not formulation, and the second portion is a sustained released form, not formulation.

[00:01:44] Speaker 00:
So what's the difference between form and formulation?

[00:01:48] Speaker 00:
Well, the difference is in the way the district court applied the word formulation.

[00:01:52] Speaker 00:
The district court

[00:01:53] Speaker 00:
applied formulation to require either two different processes or two different ingredient lists.

[00:02:00] Speaker 00:
And in doing so, departed from the ordinary meaning of the word form, which doesn't suggest any particular ingredient list, any particular process.

[00:02:11] Speaker 00:
And the district court did that based on prosecution disclaimer of disavowal, going back to this court's decision in Watson and the parent patent, the 252 patent.

[00:02:23] Speaker 00:
But this court, as recently as yesterday, held that disavowals an exacting standard under which it must be established that the patiny demonstrated an intent to deviate from the ordinary and accustomed meaning of the claim term.

[00:02:40] Speaker 00:
And the court wants to see expressions of manifest exclusion or restriction.

[00:02:44] Speaker 04:
But the court already found in Watson that those

[00:02:47] Speaker 04:
statements amounted to a disclaimer in the 252, the parent application.

[00:02:52] Speaker 04:
And so what you're asking us to do is not to have what's already been found to be a clear and manifest expression of limitation.

[00:03:01] Speaker 04:
You're asking us not to carry that through to a subsequent application in the same family, a child.

[00:03:09] Speaker 04:
I don't know if it's a child or a grandchild.

[00:03:10] Speaker 04:
I can't keep track of the lineage.

[00:03:12] Speaker 04:
But you're asking us not to carry it through.

[00:03:15] Speaker 04:
But there's already been a disclaimer that was found.

[00:03:18] Speaker 04:
So how can you demonstrate to me that the prosecution history of the child obviated the prior disclaimer?

[00:03:29] Speaker 00:
Yes.

[00:03:29] Speaker 00:
Thank you, Judge Moore.

[00:03:30] Speaker 00:
For one thing, the child was a continuation in part

[00:03:37] Speaker 00:
It was not a straight continuation.

[00:03:38] Speaker 00:
New matter was added.

[00:03:41] Speaker 00:
One of the things that the Watson decision relied on was a section in the parent patent that talked about the portions being discrete.

[00:03:52] Speaker 00:
That section does not appear anywhere in the 032 patent.

[00:03:56] Speaker 00:
More importantly, the 032 patent added a clarifying section that did not appear in the parent.

[00:04:06] Speaker 00:
that says it should be understood that for either the immediate release and or the sustained release portion, the gufenicin and optionally the additional drug may be mixed within the same matrix portion.

[00:04:22] Speaker 00:
And that appears in appendix 1406, column 4, lines 11 through 18.

[00:04:29] Speaker 00:
So there, in a section of the specification that did not exist in the parent,

[00:04:35] Speaker 00:
The patentee is making it clear that the portions do not have to be discrete.

[00:04:42] Speaker 00:
They can be mixed within the same matrix.

[00:04:46] Speaker 00:
So that's the opposite of a manifest expression of restriction.

[00:04:52] Speaker 00:
That's the patentee's putting the world on notice that we're going for something different and broader here.

[00:05:00] Speaker 00:
We're going for the ordinary meaning of the term portion.

[00:05:04] Speaker 04:
What section of the oath is this the 032 patent?

[00:05:09] Speaker 04:
What is the column and paragraph of the 032 patent that you say was different?

[00:05:14] Speaker 00:
Yes.

[00:05:15] Speaker 00:
It's column four, lines 11 through 18.

[00:05:25] Speaker 00:
And if you've got the patent up, Your Honor, it's the last few lines of the carryover paragraph.

[00:05:46] Speaker 03:
Can you repeat that, please, what?

[00:05:48] Speaker 00:
I'm sorry, the site, your honor?

[00:05:49] Speaker 03:
Yes.

[00:05:50] Speaker 00:
Column four.

[00:05:51] Speaker 00:
Okay.

[00:05:52] Speaker 00:
Lines 11 through 18.

[00:05:54] Speaker 00:
Okay.

[00:06:09] Speaker 00:
Okay, so that's one thing that the patentee did.

[00:06:13] Speaker 00:
I mean, to answer the question you asked, Your Honor, about how is this different, we should also look at what they did during prosecution.

[00:06:22] Speaker 00:
And during prosecution, what they did was they added a bunch of pharmacokinetic limitations to the claims that did not appear in the claims and the parent.

[00:06:38] Speaker 00:
And they at no time, unlike what happened during the prosecution of the parent,

[00:06:43] Speaker 00:
did not distinguish the invention from the prior art based on the portions, but instead distinguished it based on these new claim limitations they had added on the pharmacokinetic factors.

[00:06:56] Speaker 00:
And then at the same time they did that, Your Honor, they added a dependent claim, which is a dependent claim three, which says the

[00:07:11] Speaker 00:
drug product of claim one, wherein the portions, the first and second portion, are discrete.

[00:07:20] Speaker 00:
That's a clear statement, both during prosecution and in the patent itself, that what the patentees intended here was not a disclaimer or a disavowal, but rather they were intended a broader meaning for portion as it was used in claim one of the O32 patent.

[00:07:38] Speaker 00:
They intended the plain and ordinary meaning, which is

[00:07:41] Speaker 00:
It doesn't have to be discrete or distinct.

[00:07:45] Speaker 00:
Consistent with what was in the specification column four, it could be mixed together.

[00:07:54] Speaker 00:
And last but not least from the prosecution, and this appears at the appendix 3356, the paddy told the examiner that the claimed drug product is not limited to either a capsule

[00:08:12] Speaker 00:
or a bilayer tablet.

[00:08:17] Speaker 00:
Those are embodiments that would have discrete portions.

[00:08:24] Speaker 00:
They're explicitly telling the examiner that the invention is not limited to that.

[00:08:31] Speaker 00:
Again, that's the opposite of an exacting manifest exclusion or restriction.

[00:08:39] Speaker 00:
That's the patentee saying,

[00:08:43] Speaker 00:
We're intending something different here than what was intended in the parent, based on the disclaimer that was found in Watson.

[00:08:51] Speaker 03:
But that doesn't change the language of the claims, right?

[00:08:55] Speaker 03:
I mean, claim one of the 252 patent, it's identical almost to the claims that we're talking about here.

[00:09:04] Speaker 03:
You're pointing to the specification, but the claims are the same.

[00:09:08] Speaker 00:
In the parent patent?

[00:09:10] Speaker 00:
Well, the scope is different right from the outset, Your Honor, because the claim in the 252 patent was for a modified release tablet, which is, let's call it narrower than what's claimed in the 032 patent, which claims a drug product.

[00:09:29] Speaker 00:
So during the prosecution, they claimed a broader section of the invention that was disclosed in the specification.

[00:09:40] Speaker 00:
And in doing so, they made clear to explain in the specification of the 032 patent as a continuation in part that the two portions could be mixed together.

[00:09:50] Speaker 00:
In other words, not be discrete, not be distinct.

[00:09:54] Speaker 00:
And so what the district court did was to set up a claim construction construct where not only did the two portions have to be discrete or distinct, but we also had to show

[00:10:10] Speaker 00:
a separate formulation, which isn't in the 032 patent claims at all.

[00:10:17] Speaker 00:
The word formulation does appear in the 821 patent, but it does not appear anywhere in the 032 patent claim one.

[00:10:26] Speaker 00:
And so we've got a situation where the district court set up a claim destruction that so significantly departs from the ordinary meaning of the term.

[00:10:41] Speaker 00:
Either he or Ornibindo had to point to somewhere where there was a disavowal of the ordinary scope.

[00:10:49] Speaker 00:
No one did it.

[00:10:50] Speaker 00:
No one's pointed to a clear, expressed disavowal of the ordinary meaning of the term portion.

[00:11:00] Speaker 00:
And so I wanted to talk about summary judgment, if I could, but I didn't want to foreclose any other questions on claim construction.

[00:11:11] Speaker 00:
So on summary judgment, even using the district court's claim construction, summary judgment was an error as a matter of law.

[00:11:24] Speaker 00:
Wreck-it put forth direct evidence that the Orbindo drug product has two distinct formulations.

[00:11:36] Speaker 00:
And it's undisputed on this record

[00:11:39] Speaker 00:
that the Oribendo product has two different and distinct releases of glyphenicin.

[00:11:45] Speaker 00:
About a third of the glyphenicin is released rapidly within the first hour.

[00:11:52] Speaker 04:
Is it your view that the word form, which is used in the O32 patent, differs from the word formulation, which is used in the 821 and the 252 patent, and that that's one of the critical distinctions that causes

[00:12:08] Speaker 04:
the construction of the 032 patent to not be the same as that which is in Watson?

[00:12:14] Speaker 00:
Well, it's certainly one of the points, Your Honor, but the real difficulty is the way in which the district court... Where did you make this form versus formulation argument?

[00:12:25] Speaker 00:
Well, I think we pointed out throughout our brief, Your Honor, about the impropriety of the district court requiring us

[00:12:32] Speaker 04:
to point to a separate ingredient list.

[00:12:48] Speaker 04:
cannot be construed the same way as the word formulation in the 821 and or the 252.

[00:12:53] Speaker 04:
I just didn't see it anywhere and yet you led your opening argument with it today and you've repeated it now three separate times in this argument.

[00:13:02] Speaker 04:
Where in your briefs can I find it?

[00:13:05] Speaker 00:
Well, it's not as explicitly stated as I said.

[00:13:08] Speaker 00:
Not in there.

[00:13:08] Speaker 00:
I read this case thoroughly.

[00:13:11] Speaker 04:
It's confusing.

[00:13:11] Speaker 04:
The technology is hard.

[00:13:13] Speaker 04:
But you have led your oral argument with a claim construction position that I can't find anywhere in your briefs, nor do I see you having made to the district court below.

[00:13:20] Speaker 04:
I mean, are you trying to pull the wool over my eyes in a really complicated case?

[00:13:24] Speaker 00:
Absolutely not, Your Honor.

[00:13:25] Speaker 04:
I'm sitting here feeling like I must be an idiot.

[00:13:27] Speaker 04:
How did I miss that argument since you're leading your oral argument with it?

[00:13:31] Speaker 04:
I think I missed it because it's not in your briefs.

[00:13:33] Speaker 00:
Well, Your Honor, I can see it's not as explicitly stated, but it's in there.

[00:13:38] Speaker 00:
It's in there because we said that... Wait a minute.

[00:13:40] Speaker 04:
Tell me what page.

[00:13:42] Speaker 00:
Well, it's in the section of our brief, Your Honor, where we talk about the district court departing from the plaintiff ordinary meeting of the term.

[00:13:54] Speaker 04:
You don't have to waste any more time.

[00:13:55] Speaker 04:
You can, on your rebuttal, let me know what page or where in the blue brief I can find it, since you've mentioned it three times in your oral argument.

[00:14:04] Speaker 00:
I understand the point Your Honor's making.

[00:14:06] Speaker 00:
I do think that I stated it more explicitly than is stated in the brief.

[00:14:10] Speaker 02:
You're well into your report.

[00:14:12] Speaker 00:
Okay, I'll reserve, thank you.

[00:14:24] Speaker 01:
May I please the court?

[00:14:25] Speaker 01:
I'm Timothy Kratz, Representative, or Abindo, the Defense and Cross-Impellence.

[00:14:33] Speaker 01:
There's a lot to unpack here, and I'm going to make some summary statements, but I'll absolutely get into whatever details and specifics we can talk about, including the argument with respect to form.

[00:14:45] Speaker 01:
I'm happy to address that as well.

[00:14:47] Speaker 01:
This is a classic summary judgment case.

[00:14:49] Speaker 01:
This is why summary judgment exists in the federal system.

[00:14:53] Speaker 01:
There's no chance that this case was ever going to be determined, that there's going to be an infringement.

[00:14:58] Speaker 01:
They knew it from the beginning.

[00:14:59] Speaker 01:
This has been a long and moving target, but the summary judgment was finally granted in this case.

[00:15:04] Speaker 02:
Well, it's not clear they knew it from the beginning.

[00:15:07] Speaker 02:
It might be fear to say that they should have known it after the plane construction.

[00:15:11] Speaker 01:
So the Watson case was decided before this case was even brought up, three years before they received our ANDA.

[00:15:17] Speaker 01:
They received our ANDA, and it clearly says that this is a sustained release form.

[00:15:24] Speaker 01:
It does not have two portions.

[00:15:26] Speaker 01:
The ingredient list was in there.

[00:15:27] Speaker 01:
They had all the information they know to absolutely understand the conclusion that Judge Stark ultimately had and what we hope, Your Honors, will agree with us as well from day one.

[00:15:39] Speaker 01:
And then as the case progressed, it never got any better.

[00:15:42] Speaker 01:
They tested out certain theories.

[00:15:44] Speaker 01:
They abandoned those theories.

[00:15:46] Speaker 01:
They demanded our samples.

[00:15:48] Speaker 01:
We gave them samples.

[00:15:49] Speaker 01:
At one point, they had in their infringement contentions said, we have imaging data that shows

[00:15:56] Speaker 01:
the immediate release portion of our composition, of our tablet, of our thing that is supposedly infringing.

[00:16:05] Speaker 01:
We asked them for the data.

[00:16:07] Speaker 01:
They thought about giving it to us at that time.

[00:16:10] Speaker 01:
We'd go to court to try to force them to give us.

[00:16:12] Speaker 01:
They end up amending their contentions at that point, eliminating all references to imaging data whatsoever.

[00:16:19] Speaker 01:
We've still never seen that imaging data.

[00:16:21] Speaker 03:
In the Watson case, we found that single formulation

[00:16:25] Speaker 03:
tablets were disclaimed in the prosecution history.

[00:16:28] Speaker 03:
To what extent does that apply now in this particular case?

[00:16:32] Speaker 03:
Your opponent's saying it does not apply.

[00:16:34] Speaker 01:
Yeah.

[00:16:36] Speaker 01:
Two points with respect to that, Your Honor.

[00:16:38] Speaker 01:
First is, I don't think Judge Stark relies on that in its entirety by any means whatsoever.

[00:16:44] Speaker 01:
He does an independent analysis of the child patents and determines that the plain language of this claim, which we'll get into, absolutely requires there to be two portions.

[00:16:55] Speaker 01:
And whether portions means part of a whole or not, the fact is what they're ignoring is there has to be two of them.

[00:17:01] Speaker 01:
And the judge correctly decided that.

[00:17:05] Speaker 01:
With respect to the disclaimer, Judge Stark does not rely on that in order to make that determination of what the plain language of that patent says.

[00:17:15] Speaker 01:
As it turns out, I don't think there is a disclaimer here.

[00:17:18] Speaker 01:
And I think Your Honors could decide on that issue as well because there is no

[00:17:23] Speaker 01:
effort ever in the prosecution history of the 032 patent, any attempt to disavow the disavowal, to say, now we are trying to claim this broader territory.

[00:17:34] Speaker 01:
He stands before you now saying we submitted a broader patent.

[00:17:39] Speaker 01:
That's just not so.

[00:17:40] Speaker 01:
And the Patent Office didn't understand that this was a broader patent by any means whatsoever.

[00:17:45] Speaker 01:
They in fact said, as a terminal disclaimer, because there's not anything patentably distinct about the child patent versus the parent patent.

[00:17:53] Speaker 01:
And the applicants accepted that.

[00:17:56] Speaker 01:
They understood, everyone understood, this patent was no broader.

[00:17:59] Speaker 01:
In fact, it was much more narrow because it had the PK limitations on it as well.

[00:18:03] Speaker 01:
This is not a broader patent.

[00:18:04] Speaker 01:
This is not a situation.

[00:18:06] Speaker 02:
Oh, the citation your friend gave us to column four of the 032 patent.

[00:18:10] Speaker 02:
Yeah.

[00:18:10] Speaker 02:
And the language online.

[00:18:13] Speaker 02:
So.

[00:18:13] Speaker 02:
10 through 20.

[00:18:17] Speaker 01:
And this invokes the issue of claim distinction between claim one and claim three as well.

[00:18:23] Speaker 01:
And they're using the word discrete in claim three.

[00:18:27] Speaker 01:
And Judge Stark solved the problem by using the word distinct in claim one when he explained what the plain language of the claim one was.

[00:18:38] Speaker 01:
It seems to me that this extra language in here, for one, is not clear that it's saying that the immediate release force portion and the sustained release

[00:18:47] Speaker 01:
portion could actually be mixed in the same matrix.

[00:18:50] Speaker 01:
It does seem to say either of them can be.

[00:18:53] Speaker 01:
But to the extent it does say and in the and or, and it's confusing as to what it is actually saying, the answer is still there has to be two portions.

[00:19:03] Speaker 01:
They can be mixed together so that they're not discrete.

[00:19:07] Speaker 01:
And discrete is determined in claim three as being something that is, in fact, has a spatial separateness associated with it.

[00:19:17] Speaker 01:
a particular spatial separateness to it, which Judge Stark said with respect to claim one is that we're not going to use the word discrete in this claim.

[00:19:26] Speaker 01:
We're instead going to say it has to be distinct.

[00:19:28] Speaker 01:
You have to have two distinct portions.

[00:19:32] Speaker 01:
Their interpretation that this can be proven based on the performance of the drug wipes out entirely the claim language that says there has to be two portions.

[00:19:46] Speaker 04:
I'm sorry.

[00:19:47] Speaker 04:
I don't know that I followed your answer to the chief judge's question about the language at column four.

[00:19:55] Speaker 04:
Was your answer just that you think it's confusing because it says and slash or?

[00:20:01] Speaker 01:
Well, at best it's saying that things can be mixed together during the manufacturing.

[00:20:06] Speaker 01:
And we agree with that.

[00:20:07] Speaker 01:
We think that absolutely it could be.

[00:20:10] Speaker 01:
You still have to start with two portions.

[00:20:12] Speaker 01:
You have to have a portion that is at least

[00:20:16] Speaker 01:
formulation or form.

[00:20:18] Speaker 01:
You then have to have another portion that is sustained release.

[00:20:22] Speaker 01:
If you end up mixing them together in the part of your manufacturing process, it does seem that this part of the specification covers that description.

[00:20:32] Speaker 01:
And that's fine.

[00:20:33] Speaker 01:
It's not what we have here.

[00:20:34] Speaker 01:
And it's not what we have in any example or anything to do with the case.

[00:20:39] Speaker 01:
But it's true.

[00:20:39] Speaker 01:
It says what it says.

[00:20:41] Speaker 01:
And so perhaps that would be something that would be allowed.

[00:20:46] Speaker 01:
But undoubtedly, in this sentence under this column four, as well as in the claims themselves, there still has to be two portions.

[00:20:54] Speaker 01:
So we don't have that situation here.

[00:20:57] Speaker 01:
If we had that situation here, then perhaps there would be a way of proving that there are two formulations and there are two forms.

[00:21:06] Speaker 01:
And it's easy to visualize how that would happen.

[00:21:11] Speaker 01:
you would have you start in the manufacturing process with glyphenacin.

[00:21:15] Speaker 01:
Part of it you mix with rate releasing, rate controlling polymers.

[00:21:20] Speaker 01:
The other part you don't.

[00:21:21] Speaker 01:
Then you put them all together in a grinder with the other recipients, put them all together, form a tablet.

[00:21:26] Speaker 01:
You might have at that point a tablet that fits this column four.

[00:21:30] Speaker 01:
You might have a tablet that does have two portions, so it meets claim one, but they are mixed together.

[00:21:37] Speaker 01:
They wouldn't meet

[00:21:38] Speaker 01:
Claim 3, because Claim 3 requires that that be discrete.

[00:21:44] Speaker 01:
But Claim 1 doesn't say that.

[00:21:45] Speaker 01:
Claim 1 just says it has to have two portions.

[00:21:48] Speaker 01:
So then you'd have a situation that would meet Claim 4, where you have this tablet that's been grinded up and mixed together.

[00:21:55] Speaker 01:
It started with two portions, got grinded up mixed together, met Claim 1, didn't meet Claim 3.

[00:22:01] Speaker 01:
That is not what you have here.

[00:22:05] Speaker 01:
because we have the manufacturing results.

[00:22:07] Speaker 01:
They have no testimony that that's what we have here, because they did not have an expert that is qualified whatsoever to tell you anything other than what we already know, which is that our tablet is bioequivalent to their branded product.

[00:22:21] Speaker 01:
That's what they're trying to get away with.

[00:22:23] Speaker 01:
They're trying to get away with the claim not saying what it says, but instead the claim just being as long as we can show the performance of the tablet, then that's good enough to show that we've got an infringing product.

[00:22:34] Speaker 01:
That's not what they claimed.

[00:22:36] Speaker 01:
And that's not what they should be allowed to claim here.

[00:22:38] Speaker 01:
And in fact, it's egregious that they actually ask for that type of result.

[00:22:42] Speaker 04:
I'm struggling to understand your distinction between, and maybe it's not just yours, maybe it's Judge Stark's, I don't know, but distinction between discrete and distinct.

[00:22:54] Speaker 04:
I don't know what the difference between those two words is, but you seem to think it's meaningful and that claim one is limited to distinct

[00:23:04] Speaker 04:
portions in claim three is limited to discrete portions.

[00:23:08] Speaker 04:
I don't understand.

[00:23:09] Speaker 01:
There's a couple reasons why it is a difficult thing to understand.

[00:23:12] Speaker 01:
One is that they did not ask for a construction of discrete.

[00:23:16] Speaker 01:
So we don't know.

[00:23:17] Speaker 01:
And it's not something that's been appealed or issued in this case.

[00:23:22] Speaker 01:
So we don't really know.

[00:23:23] Speaker 01:
This gets down to the claim one has to mean something different than claim three.

[00:23:28] Speaker 01:
What Judge Stark did with it was he said,

[00:23:31] Speaker 01:
OK, we're not going to require there to be a particular spatial difference between these.

[00:23:38] Speaker 01:
We're not going to be particular about the distance between the two portions in claim one.

[00:23:47] Speaker 01:
In claim three, discrete does seem to imply that it has to have a particular spatial orientation.

[00:23:53] Speaker 01:
So you would have a tablet that has all the

[00:23:57] Speaker 01:
immediate release portion on one side and all the extended release portion on the other.

[00:24:03] Speaker 01:
Or a capsule that has beads, and some of the beads are immediately releasing beads and some are not.

[00:24:07] Speaker 01:
And then you can sit there and say, those things are absolutely separate and discrete from each other.

[00:24:13] Speaker 01:
So there would be a physical separation between the two.

[00:24:17] Speaker 01:
Claim one, Judge Stark said that the two portions have to be distinct.

[00:24:23] Speaker 01:
And he said, the means that there's going to imply some physical separateness, but I'm not going to require a particular spatial location of those things.

[00:24:32] Speaker 04:
Give me an example of what would be broader than the examples you gave me for discrete, for claim one.

[00:24:39] Speaker 01:
Well, one would be as if it was just pressed together.

[00:24:41] Speaker 01:
So you have the portion that had the guafinicin mixed with rate-controlling polymers and a guafinicin that was ready to be released immediately.

[00:24:53] Speaker 01:
and you just press them together in a tablet with the acceptance, you made a tablet out of that, then when you look under the microscope, you might not be able to tell the separateness of the portions, but you know it's there, because you know that they were made differently.

[00:25:08] Speaker 01:
It was made with two portions.

[00:25:10] Speaker 01:
And so that would be one way to have a tablet that... So the fact that there was a bleeding of all these

[00:25:19] Speaker 01:
these rate-controlled guava fenicin is over here as opposed to over here, you would have a situation where claim one says it doesn't matter.

[00:25:27] Speaker 01:
It's still a violation.

[00:25:28] Speaker 01:
It doesn't matter if it's perfectly distinct, as is required in claim three.

[00:25:33] Speaker 01:
You would have a tablet that has two portions.

[00:25:36] Speaker 01:
And the two portions are one of them, immediate release, and the other one, sustained release.

[00:25:40] Speaker 01:
We know that's true because this is how they did it.

[00:25:43] Speaker 01:
Now, a lot of this is hypothetical.

[00:25:44] Speaker 01:
And the reason why it's hypothetical is, first of all,

[00:25:47] Speaker 01:
Our product doesn't do that at all.

[00:25:48] Speaker 01:
Our product is a sustained release formulation, single formulation.

[00:25:52] Speaker 01:
How do we know that?

[00:25:52] Speaker 01:
That's what the ANDA says.

[00:25:54] Speaker 01:
What evidence do we have that that's not true?

[00:25:57] Speaker 01:
Nothing.

[00:25:58] Speaker 01:
They didn't take a single deposition.

[00:26:00] Speaker 01:
They didn't have any expert analyze the thing.

[00:26:03] Speaker 01:
They didn't even take our expert's deposition.

[00:26:06] Speaker 01:
This case was decided on summary judgment, not based on that expert.

[00:26:09] Speaker 01:
They didn't even bother to take his deposition to create any doubt at all about there being a genuine issue of fact in this case.

[00:26:17] Speaker 01:
There's none.

[00:26:18] Speaker 01:
They didn't do that.

[00:26:19] Speaker 01:
They had one expert.

[00:26:20] Speaker 01:
He was deposed, and he said this.

[00:26:22] Speaker 01:
I can't tell you what's in that tablet.

[00:26:25] Speaker 01:
I can't tell you how that the dissolution results I'm getting or the PK results that are happening in the ANDA

[00:26:33] Speaker 01:
how that works.

[00:26:34] Speaker 01:
I can't tell you that for two reasons.

[00:26:36] Speaker 01:
One is, the only way to find that out is if you looked at the ingredient list and the manufacturing process, I wasn't asked to do that.

[00:26:43] Speaker 01:
And not only that, I'm not qualified to do that if I was asked.

[00:26:46] Speaker 01:
That's their only witness.

[00:26:49] Speaker 01:
They didn't come with any evidence in this case at all.

[00:26:51] Speaker 01:
They just want you to understand and believe that the way that these claims are written is all we have to do is show performance of the drug.

[00:26:59] Speaker 01:
We don't have to show you anything about the tablet

[00:27:02] Speaker 01:
that's created and claimed in the patent.

[00:27:05] Speaker 01:
But it's a drug product patent.

[00:27:07] Speaker 01:
It's not a performance patent.

[00:27:09] Speaker 01:
They have PK limitations in there.

[00:27:10] Speaker 01:
They want you to believe that that's the only thing that they have to show.

[00:27:14] Speaker 01:
And it's just not so.

[00:27:15] Speaker 01:
The claims have more than that.

[00:27:16] Speaker 01:
And they came with no evidence about that whatsoever.

[00:27:19] Speaker 01:
So we're in hypothetical land with respect to, well, what does discrete mean?

[00:27:23] Speaker 01:
What does distinct mean?

[00:27:24] Speaker 01:
And so we're trying to figure out how it could possibly be.

[00:27:27] Speaker 01:
The plain language of claims one and claim three, for that matter,

[00:27:31] Speaker 01:
says you have to have two portions.

[00:27:33] Speaker 01:
We don't have two portions.

[00:27:35] Speaker 01:
And this case is as simple as that at bottom.

[00:27:37] Speaker 01:
That's why I started this saying that they knew from the beginning that this was a case that they could not win.

[00:27:44] Speaker 01:
And that's why summary judgment was decided.

[00:27:47] Speaker 01:
We'll talk about that.

[00:27:48] Speaker 01:
That's why this case is exceptional.

[00:27:52] Speaker 01:
And we've cross appealed on this because if there's ever a case

[00:27:55] Speaker 01:
that should be exceptional in this case, in this particular case, because they came with nothing.

[00:28:01] Speaker 01:
They never tried to create any doubt about the ultimate result in this study.

[00:28:07] Speaker 01:
They buried evidence that they looked at.

[00:28:09] Speaker 01:
They at one time said that they thought they had imaging data.

[00:28:12] Speaker 01:
They had one expert, and the expert said, I don't know anything about the ultimate issues in this case.

[00:28:18] Speaker 01:
And yet here we are still.

[00:28:21] Speaker 01:
I'm happy to answer any more.

[00:28:24] Speaker 01:
No questions.

[00:28:29] Speaker 00:
Thank you.

[00:28:29] Speaker 00:
Judge Moore, I did go back and look.

[00:28:33] Speaker 00:
And I thought when I made the statements earlier that I prefaced it with the issue with the word form versus formulation was in how the district court applied the term formulation.

[00:28:44] Speaker 00:
That was the argument I was making.

[00:28:46] Speaker 00:
If I wasn't clear, I apologize.

[00:28:47] Speaker 02:
That appears.

[00:28:48] Speaker 02:
Can you repeat what you just said, that the district court wasn't doing what?

[00:28:52] Speaker 00:
The way the district court

[00:28:53] Speaker 00:
applied the word formulation.

[00:28:56] Speaker 00:
In other words, what the district court required in terms of proof.

[00:28:59] Speaker 00:
When I was making the form formulation argument, what I was trying to say, perhaps inartfully, was that the district court imparted a meaning of formulation that required us to prove certain things, like separate ingredient lists.

[00:29:16] Speaker 00:
That argument appears on pages 40, 41, and 42 of our opening brief, and that was

[00:29:22] Speaker 00:
the basis of what I had said earlier, Your Honor.

[00:29:25] Speaker 00:
In terms of rebuttal on the proof that we had, our expert had 50 years of experience in this field.

[00:29:33] Speaker 00:
They sought to exclude him.

[00:29:36] Speaker 00:
Judge Stark found him to be qualified to testify and said that he would assist the trier of fact.

[00:29:43] Speaker 00:
And what our expert said is that there, based on all the data in the ANDA,

[00:29:48] Speaker 00:
and the data that resulted from our own testing was that the Ourobindo product has two distinct releases of gofenicin.

[00:30:02] Speaker 00:
It has an initial release, which is an immediate release, wherein 33 percent or thereabouts.

[00:30:08] Speaker 03:
Did you present any type of expert evidence that would rebut Ourobindo's position?

[00:30:16] Speaker 00:
Yes.

[00:30:18] Speaker 00:
Yes, the testimony and the analysis of our expert was that it was only possible to have two different releases of glofenicin at two different rates, one very fast, where about half, I'm sorry, about 33% of the glofenicin is released in the first hour, and a second much slower release where the remaining two-thirds is released over 12 or 13 hours, that it's only possible

[00:30:47] Speaker 00:
for that to occur if there are two formulations.

[00:30:50] Speaker 03:
And our experts... That goes to the dissolution rates.

[00:30:55] Speaker 00:
Well, the argument that they've made on appeal is that we're conflating the PK factors from the dissolution rate.

[00:31:04] Speaker 00:
We're not.

[00:31:05] Speaker 00:
The fact is you can meet the claim limitation on having two different rates of release, an immediate and a sustained, without also meeting the PK limitations.

[00:31:16] Speaker 00:
So we're not conflating the two at all.

[00:31:20] Speaker 00:
The fact is there are, without any dispute, two distinct releases of glyphenacin.

[00:31:28] Speaker 00:
And our expert testified at Appendix 6208.

[00:31:33] Speaker 00:
He said that the data supports the existence of both a fast fraction or quantity of glyphenacin in an immediate release formulation and

[00:31:46] Speaker 00:
a slow fraction or another quantity of glofenicin in a release delaying matrix or sustained release formulation.

[00:31:55] Speaker 00:
He says it's not singular, homogenous, or a sustained release formulation.

[00:32:01] Speaker 00:
Based on the analysis, he says there is an immediate release quantity of glofenicin within the first hour, followed by, in other words distinct from, a sustained release of a second quantity of glofenicin

[00:32:15] Speaker 00:
with an overall biphasic release profile.

[00:32:19] Speaker 00:
And he concludes, several places in his report, paragraph 72 and paragraph 100, that this is only possible if there is two different quantities, two different forms of glyphenosine in the tablet.

[00:32:38] Speaker 00:
Thank you.

[00:32:39] Speaker 00:
Thank you.

[00:32:40] Speaker 02:
Thank both sides in the cases.