[00:00:09] Speaker 02:
All right.

[00:00:39] Speaker 02:
The United States Court of Appeals for the Federal Circuit is now open and in session.

[00:00:44] Speaker 02:
God save the United States and its honorable court.

[00:00:48] Speaker 01:
Please be seated, ladies and gentlemen.

[00:00:50] Speaker 01:
Good morning.

[00:00:57] Speaker 01:
We have six cases on our calendar this morning.

[00:01:02] Speaker 01:
Four patent cases.

[00:01:04] Speaker 01:
Three of them from the PTO, one from the district court.

[00:01:07] Speaker 01:
We have a government employee case from the Merit Systems Protection Board and a case from the Veterans Court.

[00:01:17] Speaker 01:
The Veterans case and one of the PTO cases are being submitted on the briefs and will not be argued.

[00:01:23] Speaker 01:
And our first case is Forest Laboratories versus Deva Pharmaceuticals 2016, 2550 and 2553.

[00:01:32] Speaker 01:
Mr. Papas.

[00:01:39] Speaker 05:
Thank you, Your Honor.

[00:01:40] Speaker 05:
Good morning.

[00:01:44] Speaker 05:
May it please the Court.

[00:01:45] Speaker 05:
This case presents a single narrow issue.

[00:01:49] Speaker 05:
That is, whether the 50% limitation of Claim 1 of the 209 patent is indefinite.

[00:01:58] Speaker 05:
Before beginning my argument, I'd like to make two points to outline for the Court where I intend to proceed to address the merits.

[00:02:06] Speaker 05:
First, Claim 1

[00:02:08] Speaker 05:
we submit is not indefinite because the district court misconstrued claim one, and under the proper construction, a post-sub would readily understand the scope of the claim.

[00:02:19] Speaker 01:
Second... Mr. Pappas, don't you have a more serious problem of indefiniteness?

[00:02:24] Speaker 01:
This is a claim of composition of an extended release formulation providing a concentration profile, and you're talking about

[00:02:37] Speaker 01:
how to measure it.

[00:02:41] Speaker 01:
This is an empty claim.

[00:02:42] Speaker 01:
It doesn't tell you what it is that is necessary to produce this sustained release and to get this result.

[00:02:53] Speaker 01:
It claims all ways of getting this result.

[00:02:57] Speaker 01:
Now, you know this patent inside out and out.

[00:03:00] Speaker 01:
But when you look at claims seven and nine, it starts to tell you what it is.

[00:03:04] Speaker 01:
It gives you

[00:03:08] Speaker 01:
definite ways of achieving the results.

[00:03:13] Speaker 01:
And when you go to the examples, Example 12, for example, is entitled Preparation of Memantine Controlled Release Formulation.

[00:03:27] Speaker 01:
So Claim 1 is, why isn't it dead in the water?

[00:03:32] Speaker 01:
Because it is indefinite and doesn't tell you how to get to the

[00:03:37] Speaker 01:
claimed result.

[00:03:39] Speaker 05:
Your Honor, I would respectfully say that I think it does tell the person with ordinary skill in the art how to get to the result, because basically what claim one covers is a relative measurement between the IR plasma profile and the extended release plasma profile.

[00:03:58] Speaker 01:
But what is in there that gives you that profile, aside from how you measure it?

[00:04:06] Speaker 05:
And Your Honor, first of all, with respect to the extended release, it's our position that any poster would know how to conduct a human trial of the extended release profile.

[00:04:19] Speaker 05:
And candidly, that was not presented by the court.

[00:04:21] Speaker 01:
But what do you put in the composition that makes the claim definite?

[00:04:25] Speaker 01:
It's missing.

[00:04:26] Speaker 01:
There's nothing there.

[00:04:28] Speaker 05:
Well, Your Honor, we would say it's definite because it also tells you what you compare it to.

[00:04:34] Speaker 05:
Once you conduct the

[00:04:36] Speaker 05:
human trial with a single dose of the extended release, it gives you certainty by indicating to you, because it's the only comparator in the claim, is you use Figure 1A as replicated in Figure 2D.

[00:04:50] Speaker 05:
And if Your Honor will note, on page 5 of our brief, there is a picture of Figure 1A, and we've highlighted in red what is the comparator.

[00:05:03] Speaker 05:
And that is what the patentee chose to be the comparator against which you could measure the results of any extended release human trial.

[00:05:15] Speaker 05:
And again, as I said, it's a relative measurement as to whether or not the extended relief is 50% less.

[00:05:21] Speaker 01:
This claim isn't about measurements.

[00:05:24] Speaker 01:
The claim is about a composition.

[00:05:28] Speaker 05:
Well, Your Honor, I think the essence of claim one is about the measurements.

[00:05:33] Speaker 01:
It basically reads a solid pharmaceutical composition comprising an extended release formulation.

[00:05:41] Speaker 01:
But go ahead.

[00:05:43] Speaker 05:
A 5 to 50 milligrams memantine wherein the administration of the dose provides a plasma memantine concentration profile as measured in a single dose human PK study.

[00:05:55] Speaker 05:
And we say once that's done, it's measured against the IR.

[00:06:00] Speaker 05:
graph.

[00:06:01] Speaker 00:
And I might say, Your Honor, this... Sorry, how do you get that out of Figure 1, and is it 1A and 2D?

[00:06:07] Speaker 00:
It's the same thing.

[00:06:09] Speaker 00:
When in those figures, let's call them both of the comparators, that is the IR and the ER are just computer generated.

[00:06:19] Speaker 05:
Well, Your Honor, first of all,

[00:06:21] Speaker 05:
Figure 1A gives you the IR profile.

[00:06:25] Speaker 00:
It also gives you the ER profile.

[00:06:28] Speaker 05:
The ER profile you generate based on a human PK study.

[00:06:33] Speaker 00:
That's what the claim provides.

[00:06:34] Speaker 00:
But figure 1 is an illustration of a comparison between two computer-generated profiles, right?

[00:06:43] Speaker 05:
Yes, Your Honor.

[00:06:44] Speaker 00:
They're based on human data.

[00:06:49] Speaker 00:
I'm sorry, I don't know what it means by human data computer generating.

[00:06:52] Speaker 00:
They're both human generated profiles and this is illustrating a theoretical example of what

[00:07:01] Speaker 00:
these concentration profiles might look like in which, as it happens, at the t max, the concentration is twice, is double in the immediate release from what it is in the extended release.

[00:07:16] Speaker 00:
Because all the dc dt just washes out.

[00:07:19] Speaker 00:
You're just comparing concentrations.

[00:07:22] Speaker 05:
So I want to follow your question, Your Honor.

[00:07:24] Speaker 00:
Right.

[00:07:24] Speaker 00:
So your entire argument is that a

[00:07:29] Speaker 00:
figure that shows two computer things teaches that when, as you, as you agree, the claim requires one of them has to be human.

[00:07:39] Speaker 00:
The other one stays computer.

[00:07:42] Speaker 05:
Correct, your honor.

[00:07:43] Speaker 05:
Cause that's what the inventors, that's what the inventors, that's what the inventors chose.

[00:07:47] Speaker 00:
What language in the spec, what language in the spec says that even when as required, undisputedly,

[00:07:56] Speaker 00:
The ER profile is measured in a human study that the comparator is still a computer model.

[00:08:03] Speaker 05:
Your Honor, our answer to that is the specification in its entirety teaches that because it's the only comparator that the patentee points to.

[00:08:13] Speaker 05:
And that's the purpose of figures 1A and 2D.

[00:08:16] Speaker 05:
To hold otherwise, we submit respectfully, would read 1A and 2D out of the claims.

[00:08:22] Speaker 05:
They would have no meaning at all.

[00:08:24] Speaker 05:
That's what they teach the skilled artists.

[00:08:26] Speaker 05:
is to compare the human trial to the comparator, which is 1A and 1B.

[00:08:32] Speaker 05:
And I would add, Your Honor, that the information that is contained in 1A and 2D comes from the Gastro Plus program, which, as the record will show, stimulates the actual behavior of the drugs in individuals.

[00:08:50] Speaker 05:
And it's been used by the FDA Office of Generic Drugs to predict.

[00:08:56] Speaker 05:
what will take place.

[00:08:58] Speaker 05:
So that's the comparator that the patentee chose.

[00:09:03] Speaker 05:
And our point is whether or not all skilled artisans would have chosen to compare, as the claim requires, the human profile from the ER to the individual profile that's in 1A and 2D, which ended up being a form of a standard, is what the inventor discloses.

[00:09:24] Speaker 05:
So aside from any qualitative judgment,

[00:09:27] Speaker 05:
That's what the inventors chose, and therefore we contend it's not indefinite.

[00:09:34] Speaker 05:
One may not have found the same solution that the inventor found, but as we know, the test for indefiniteness is whether or not, to reasonable certainty, the posa, the person of ordinary skill in the art, can discern the scope of the claim.

[00:09:50] Speaker 04:
But Your Honor, we have... What's the input data that was used and point to the specification for the

[00:09:56] Speaker 04:
the input data that was used in order to formulate or to get those computer formulations that you have.

[00:10:07] Speaker 05:
Your Honor, the specific input data for the figures 1A and 2D, the underlying data.

[00:10:14] Speaker 05:
The computer simulations, I meant.

[00:10:15] Speaker 05:
Yes, but is not in the specification.

[00:10:17] Speaker 05:
However, gastro plus in the discussion.

[00:10:21] Speaker 04:
So there's no input data in the specification

[00:10:24] Speaker 04:
that shows how those computer simulations were achieved.

[00:10:28] Speaker 05:
Your Honor, there is.

[00:10:29] Speaker 05:
And it also is supplemented by the Pauley Declaration.

[00:10:34] Speaker 05:
The Gastro Plus computer simulation is well known in the art.

[00:10:40] Speaker 05:
Any poster would have known how it was generated.

[00:10:43] Speaker 05:
The FDA uses it as their way to predict how a drug will behave.

[00:10:51] Speaker 04:
What's the input data that a placenta would use in order to achieve

[00:10:54] Speaker 04:
to make the comparison with the computer simulations?

[00:10:58] Speaker 05:
Well, he would know, or she or she would know, that how GastroPlus works, because it's a well-recognized tool, and you get the figure 1A, which is the IR curve.

[00:11:12] Speaker 05:
And what it actually gives the POSA is something very concrete and firm, not subject to many of the variables that I expect my opposing counsel will talk about.

[00:11:21] Speaker 05:
That gives you figure 1A

[00:11:24] Speaker 04:
gives you that, and you get your... I guess that's what I'm looking at, too.

[00:11:28] Speaker 04:
The human variables, how are they accounted for?

[00:11:33] Speaker 05:
Well, they're accounted for, in effect, because, first of all, you get all the human data from the ER, but in the IR, it's accounted for because all of the human data that has been fed into Gascro Plus to generate, in this case, the immediate release curve, has been derived from human data, and there has been found by the FDA to be an excellent

[00:11:54] Speaker 05:
predictor.

[00:11:55] Speaker 05:
And so what I'm attempting to make in terms of a point is it actually gives the post of some comfort in terms of definiteness.

[00:12:02] Speaker 05:
They know exactly where to go with the results of the extended release formulation.

[00:12:07] Speaker 05:
You look at 1A, you know what the T max is.

[00:12:12] Speaker 05:
Half of that gets you your 50% line.

[00:12:14] Speaker 05:
And then you can determine whether the ER formulation is above or below that line.

[00:12:20] Speaker 05:
But I must say, Your Honors, we have two arguments.

[00:12:24] Speaker 05:
And it's important for me to address as I see my time going, the alternative argument.

[00:12:30] Speaker 00:
That is that- Didn't you waive the alternative argument quite expressly below?

[00:12:36] Speaker 00:
You said to Judge Stark that if you're going to start looking at human study versus human study, that Teva is wrong in suggesting as an alternative that

[00:12:51] Speaker 00:
the IR and the ER have to be assessed in the same human study?

[00:12:56] Speaker 05:
We had a difference of opinion below, Your Honor.

[00:12:59] Speaker 05:
That's correct.

[00:13:00] Speaker 00:
The gentle way of making the point that you argued against.

[00:13:02] Speaker 00:
We had a difference of opinion.

[00:13:03] Speaker 05:
However, the court, the district court had that construction before them.

[00:13:11] Speaker 00:
But how can you rely on that here when you specifically said that would be quite an incorrect claim construction?

[00:13:18] Speaker 05:
Because what we're here to do, Your Honor, is address the question of indefiniteness.

[00:13:23] Speaker 00:
But indefiniteness is dependent on either if you can't construe it, which is not this case, or on the adoption of the correct claim construction and then assessing whether under that claim construction the ordinary skilled artisan would know whether a given thing was inside or out with reasonable certainty.

[00:13:46] Speaker 05:
Correct.

[00:13:47] Speaker 05:
And what we're saying is

[00:13:48] Speaker 05:
Both constructions were before the court.

[00:13:50] Speaker 05:
We've briefed it.

[00:13:51] Speaker 05:
I would suggest that the waiver doctrine, as I understand it, that often the Court of Appeals applies is resistance to a claim construction that's offered for the first time on appeal and was not there to be considered by the district court.

[00:14:07] Speaker 05:
So we contend that error was committed in two ways.

[00:14:11] Speaker 05:
One, we believe the district court should have adopted our claim construction in using 1A as replicated in 2D for purposes of the comparison.

[00:14:25] Speaker 05:
And it's not indefinite.

[00:14:26] Speaker 01:
You're well into your rebuttal time.

[00:14:28] Speaker 01:
You can continue or save it.

[00:14:31] Speaker 05:
I will save it, Your Honor, and I'll address more about the alternative argument on my rebuttal.

[00:14:38] Speaker 01:
Mr. Schumer.

[00:14:42] Speaker 03:
Thank you, Your Honor.

[00:14:43] Speaker 03:
Good morning.

[00:14:44] Speaker 03:
May it please the court.

[00:14:47] Speaker 03:
This is a case where the district court correctly interpreted the claim.

[00:14:51] Speaker 03:
The claim was subject to amenable to construction.

[00:14:54] Speaker 03:
He construed it.

[00:14:55] Speaker 03:
It was proper.

[00:14:56] Speaker 03:
And then he applied factual findings to the two expert reports before him.

[00:15:00] Speaker 03:
He made factual findings, including credibility determinations.

[00:15:04] Speaker 03:
And he concluded that the patent was indefinite.

[00:15:06] Speaker 03:
In fact, the whole family of patents, the five patents, were indefinite.

[00:15:10] Speaker 03:
There's been no clear error shown

[00:15:12] Speaker 03:
in those factual findings by the appellee, and this court should affirm the district court below.

[00:15:19] Speaker 00:
Can I talk to you about what is Mr. Pappas' alternative argument that you did say to the district court, we think the right claim construction here is any old ER human study and any old IR human study, and under that construction, this is so wildly variable, it's indefinite.

[00:15:41] Speaker 00:
And that, as I understand it, is what Judge Stark concluded, that A, that's the right construction, and B, that under that construction it's indefinite.

[00:15:51] Speaker 00:
But then you said in the alternative, construe the claim to require both the ER and the IR to be evaluated in the same human study.

[00:16:01] Speaker 00:
And one of the things that your expert says is any skilled artisan would know you had to do that because you can't mix and match studies.

[00:16:10] Speaker 00:
So why is that your alternative construction, not the right construction?

[00:16:17] Speaker 03:
Is that issue waived?

[00:16:19] Speaker 03:
It is certainly waived.

[00:16:20] Speaker 00:
Where in your red brief did you say they waived this and they can't raise it?

[00:16:26] Speaker 03:
I can't point to a page in your honor, but let me see.

[00:16:29] Speaker 03:
We had a footnote that had the Sage Products case and the

[00:16:34] Speaker 03:
the key pharmaceutical case and the Finnegan case.

[00:16:37] Speaker 03:
So that would be, I believe, where it is, Your Honor, because that's the waiver.

[00:16:40] Speaker 01:
Footnotes don't constitute arguments.

[00:16:47] Speaker 03:
Pardon me.

[00:16:49] Speaker 03:
I think the footnote accompanied text, I'd have to find it.

[00:16:53] Speaker 03:
But it is clearly a waiver argument, as you suggest.

[00:16:57] Speaker 03:
Why we can raise it, as an appellate standpoint, as the FLE, I can raise any standard or argument that supports the judgment.

[00:17:05] Speaker 03:
That's just the way appellees work.

[00:17:08] Speaker 03:
On the appellant side, though, you do have a waiver if you are making that argument and you're changing positions on appeal.

[00:17:15] Speaker 03:
But let me answer you substantively, because I think it's more important to understand what happened.

[00:17:20] Speaker 03:
When we narrowed our claim interpretation, we did not say that that claim interpretation would render the claim indefinite.

[00:17:27] Speaker 00:
No, but my understanding is that

[00:17:33] Speaker 00:
The question of indefiniteness, if the claim is construed to require both ER and IR to be evaluated in the same human study, simply has not been decided.

[00:17:45] Speaker 03:
I believe it has, Your Honor, and here's why.

[00:17:48] Speaker 03:
Because when we narrowed our definition down, well, let's take a step back.

[00:17:52] Speaker 03:
Our experts said that there's variability between studies.

[00:17:56] Speaker 03:
So there's variability between study A and study Z.

[00:17:59] Speaker 03:
And that was the basis of our primary claim interpretation argument.

[00:18:04] Speaker 03:
He said if you narrow it down to using the same human study, you will minimize, and he used the word minimize, some of the problems.

[00:18:13] Speaker 03:
He didn't say you would eliminate them.

[00:18:15] Speaker 00:
No, I don't read what he said as a concession of definiteness, but I also don't read the district court as having found that if you take that approach,

[00:18:28] Speaker 00:
it would be indefinite.

[00:18:30] Speaker 00:
I take it this to be, I guess I understood that this issue really has not been litigated because the claim construction that it depends on is one that Forrest said was wrong, and Judge Stark seems to have agreed with that.

[00:18:45] Speaker 03:
I think Judge Stark's findings were broad enough to cover the alternative interpretation in Appendix Page 36 and 37, I believe it is.

[00:18:55] Speaker 03:
Or is it 37 or 38?

[00:18:56] Speaker 03:
Let me find it.

[00:18:58] Speaker 03:
It's 37 bridging on to 38.

[00:19:02] Speaker 03:
Because the judge, even if you use the same human studies, the same human study for two IR and ER formulations, you still have the possibility that one skilled in the ARC could pick any number of study designs.

[00:19:16] Speaker 03:
So you could still have a study A and a study Z. They would just be with the same humans now, or the same conditions.

[00:19:24] Speaker 03:
But there's still different tests.

[00:19:26] Speaker 03:
And if you look at the findings of fact that the judge made down below, he still credited our expert, Dr. Bergstrom, with the fact that even in an appropriately designed study, and he put it in parentheses, even an appropriately designed study, which is what we're talking about here, you would still have variation between study designs.

[00:19:45] Speaker 03:
And he rendered the claims indefinite.

[00:19:47] Speaker 00:
So Mr. Pappas said in his gray brief that the variation that that testimony refers to

[00:19:54] Speaker 00:
was not a variation in the relative numbers that is between the ER and IR, but more or less full stop.

[00:20:04] Speaker 00:
There may have been testimony about variation in what ERs you would get and maybe what IRs you would get, but that the testimony did not reach the ratio, which is the only thing the claim is concerned with.

[00:20:16] Speaker 03:
Well, that's not true.

[00:20:17] Speaker 03:
The claim is concerned with the ratio, but indefinite is concerned with whether you'll get a different result.

[00:20:23] Speaker 03:
with that ratio between tests.

[00:20:25] Speaker 03:
So one skilled in the art could pick test A and run it and eliminate or minimize, as our experts said, some of the variables there.

[00:20:33] Speaker 03:
But then you could run test Z as well and minimize the variables there.

[00:20:38] Speaker 03:
But you still have variation between these two tests or between test G or H or X, Y, Z. And that was the point of the district court's finding on the first claim interpretation.

[00:20:49] Speaker 03:
And it doesn't change with the alternative claim interpretation.

[00:20:53] Speaker 03:
You still have that inter-variability.

[00:20:56] Speaker 04:
Does the Gastro Plus software that's used in the computer simulations, does that account for the variations you're talking about?

[00:21:03] Speaker 03:
No.

[00:21:04] Speaker 03:
In fact, if you look at Dr. Grossstrom's opinion, the declaration, at the appendix page 662, at paragraph 101, he talks about all of the various things that you have to put into Gastro Plus.

[00:21:19] Speaker 03:
He says you need to have dissolution pH.

[00:21:23] Speaker 03:
Population characteristics, age, sex, weight, health history, diet condition, fasted versus fed, all of these things need to be put in.

[00:21:31] Speaker 03:
These are all different ways you can design a study.

[00:21:34] Speaker 03:
I could design study A that's adults that are fed, or I could design study Z that are pediatrics and unfed.

[00:21:43] Speaker 03:
And I can mix and match these variables.

[00:21:45] Speaker 03:
And that's what the gravamen of the opinion was, is that you can design all of these studies.

[00:21:50] Speaker 03:
But that patent doesn't tell you which one to design.

[00:21:53] Speaker 03:
You can design all these studies, and when you do that, you're going to get variations among those studies that allow you to say, sometimes it'll infringe and sometimes it doesn't.

[00:22:03] Speaker 03:
And Berkstrom, Dr. Berkstrom gave a specific concrete example of that in his declaration.

[00:22:10] Speaker 03:
So the district court's findings extend beyond the initial claim interpretation that he made.

[00:22:16] Speaker 03:
If you choose that there's not a waiver and you choose this alternative interpretation,

[00:22:23] Speaker 03:
The district court's findings still are not clearly erroneous and render the claim indefinite.

[00:22:29] Speaker 03:
So you would have to affirm, in my opinion, regardless.

[00:22:35] Speaker 03:
But I do believe there's a waiver, Your Honor.

[00:22:37] Speaker 03:
I do believe you cannot, in all fairness to a district court judge, make an argument and then win on it, which is what happened here, and then come up on appeal and say, it's legalized.

[00:22:49] Speaker 00:
They didn't win.

[00:22:50] Speaker 00:
They're the appellant.

[00:22:51] Speaker 03:
Well, they won on that issue.

[00:22:53] Speaker 03:
They won on that issue and estoppel goes by issue.

[00:22:55] Speaker 00:
And it did them no good.

[00:22:57] Speaker 03:
Well, but this court talks about getting a second bite at the apple, which is what this doctrine is supposed to prevent.

[00:23:04] Speaker 03:
And this is what they're doing on appeal, trying to get a second bite at the apple.

[00:23:08] Speaker 00:
Even though what they're now doing is saying, you know, on second thought Teva was right about this point.

[00:23:16] Speaker 03:
Well, it would have been nice to litigate that below.

[00:23:17] Speaker 00:
I'm not quite sure who blacks.

[00:23:20] Speaker 00:
standing to be asserting.

[00:23:22] Speaker 00:
I mean, you reach kind of arguing now against exactly what you argued below.

[00:23:26] Speaker 03:
Except that as an appellee, as Your Honors are aware, I am allowed to support the judgment with any arguments, whether they contradict me or not, because that is the judicial process for trying to give certainty to what's happening at the judicial court and to respect the process.

[00:23:45] Speaker 03:
So, appellees and appellants are, I think, situated differently

[00:23:49] Speaker 03:
in this issue of estoppel, and even the cases show that.

[00:23:57] Speaker 00:
Can I ask you one highly technical question?

[00:24:00] Speaker 00:
Of course.

[00:24:01] Speaker 00:
There's this old 709 patent that was originally in the 121 action.

[00:24:08] Speaker 00:
And yet I don't see a judgment about that patent.

[00:24:12] Speaker 00:
How did it disappear from the case?

[00:24:14] Speaker 00:
I'm kind of guessing it expired and somehow you all agreed to remove it, but finality of all the claims in the case is rather important to our jurisdiction.

[00:24:24] Speaker 03:
I'm sorry, I don't know what happened to the 709 patent.

[00:24:32] Speaker 03:
Is it in the list?

[00:24:33] Speaker 03:
It's not in the list.

[00:24:35] Speaker 00:
It's in one of the two complaints, the 1-2-1 case.

[00:24:40] Speaker 00:
The 1-2-1 being one of the two district court docket numbers.

[00:24:43] Speaker 03:
Oh, I see.

[00:24:44] Speaker 03:
Did the district court sweep it into its claim interpretation?

[00:24:50] Speaker 00:
We shouldn't be taking up time on this.

[00:24:51] Speaker 00:
I thought you would have a very simple answer as to why we have a final judgment in front of us.

[00:24:57] Speaker 04:
But, counsel, the record does contain a

[00:25:01] Speaker 04:
the sole single-dose human PK study, and that's in the prosecution history.

[00:25:06] Speaker 04:
Why isn't that enough to support the figures 1A and 2D?

[00:25:12] Speaker 03:
It's not, because if you look at that declaration... The WINT declaration?

[00:25:18] Speaker 03:
The WINT declaration.

[00:25:20] Speaker 03:
He lists that data, and then in a parenthetical, he says that it's consistent with the Mendel label.

[00:25:29] Speaker 03:
And let me see if I can find it here.

[00:25:31] Speaker 03:
It's at appendix page 472.

[00:25:35] Speaker 03:
So Dr. Wendt, when he's describing what's covered by his claims, does not give the human data and then say it's consistent with the computer-generated data in the patent.

[00:25:48] Speaker 03:
He says, here's my human data, and it's consistent with more human data that's found in the Namenda label.

[00:25:57] Speaker 03:
I think that the computer data and the patent is one of these vestiges of disclosed but not claimed.

[00:26:02] Speaker 03:
I mean, oftentimes in patents, you put data in there thinking you might claim it sometime, but you don't.

[00:26:11] Speaker 03:
I mean, the claims clearly contemplate human data, not computer data.

[00:26:15] Speaker 03:
It wasn't claimed.

[00:26:16] Speaker 03:
It was disclosed clearly in the patent but not claimed.

[00:26:18] Speaker 03:
And I think the simple answer is why it's there.

[00:26:20] Speaker 03:
It's one of those vestiges of things that are dedicated to the public because they were disclosed but not claimed.

[00:26:27] Speaker 01:
Data?

[00:26:28] Speaker 01:
Data dedicated to the public?

[00:26:30] Speaker 03:
Well, information can be dedicated.

[00:26:32] Speaker 01:
This is a composition.

[00:26:33] Speaker 03:
Yeah, I do agree.

[00:26:34] Speaker 03:
I had not thought about that, but it is a composition claim.

[00:26:37] Speaker 03:
And there's no structure.

[00:26:39] Speaker 03:
The only thing that's described is the memantine, which is the active ingredient, which does not provide the extended release.

[00:26:46] Speaker 03:
So yes, this is an empty claim.

[00:26:48] Speaker 03:
It has no structure.

[00:26:50] Speaker 03:
And it wasn't decided below, but certainly I agree with you, Your Honor.

[00:26:55] Speaker 00:
Was it argued below?

[00:26:56] Speaker 00:
Did you make the... You focused just on the indefiniteness of essentially the functional... Language.

[00:27:03] Speaker 03:
Yeah.

[00:27:04] Speaker 03:
That's correct, Your Honor.

[00:27:05] Speaker 03:
That's correct.

[00:27:07] Speaker 03:
So in conclusion, Your Honors, if you have no further questions, as I said, this is a case where the plain construction is amenable to construction.

[00:27:15] Speaker 03:
The district court found a proper construction.

[00:27:18] Speaker 03:
looked at the evidence in this case, weighed and balanced the declarations of the experts, and came to the conclusion, even making credibility findings, that one expert was more credible than the other, and concluded the patent was indefinite.

[00:27:32] Speaker 03:
This panel should affirm that decision.

[00:27:34] Speaker 03:
Thank you.

[00:27:35] Speaker 01:
Thank you, Mr. Schuman.

[00:27:40] Speaker 01:
Mr. Karpus will give you your three minutes of rebuttal.

[00:27:44] Speaker 00:
Thank you, Your Honor.

[00:27:45] Speaker 00:
Do you have any enlightenment?

[00:27:46] Speaker 00:
I should have said the 703 patent, I think, not the 709.

[00:27:49] Speaker 00:
Do you know what happened to that?

[00:27:50] Speaker 05:
We're checking on that now, Your Honor.

[00:27:53] Speaker 05:
Let me say, first of all, on the continued argument on our alternate construction, and I want to address Judge Rainey, your question as well.

[00:28:02] Speaker 05:
Simply put, a fair reading of Judge Stark's opinion, he did not decide this issue.

[00:28:08] Speaker 05:
When you read through that portion of his opinion when he got to this claim limitation,

[00:28:14] Speaker 05:
He basically focused, it says, human trial, everything has to be a human trial, and that was the end of the analysis.

[00:28:23] Speaker 05:
And so he never, there's no evidence that we can find in the record that he actually considered the alternate construction, but nevertheless, it was before him, and has reread the waiver cases that was not in any sense waived.

[00:28:35] Speaker 05:
Our argument then, as it is in what it is today, is we believe our primary position is correct, but if not,

[00:28:43] Speaker 05:
This court, we believe,'s obligation is to decide whether or not this claim is indefinite.

[00:28:49] Speaker 05:
And if you adopt the alternate construction, which is that the IR profile and the ER profile are produced in the same study, then all the variability is gone.

[00:29:05] Speaker 05:
And Judge Toronto, to your questions, I think we need to point to certain sections of

[00:29:13] Speaker 05:
the declaration.

[00:29:16] Speaker 04:
Bergstrom?

[00:29:17] Speaker 05:
Bergstrom.

[00:29:18] Speaker 05:
Specifically, on Appendix 663, he says that, I'm sorry, 671, he says, because different PK studies with different subjects will generally provide different Tmax and Cmax values, the only way to reliably determine whether an ER-mementine composition is less than 50%

[00:29:42] Speaker 05:
of the IR is to use the same study.

[00:29:46] Speaker 05:
He tells us it's the same study.

[00:29:49] Speaker 05:
And in Appendix 640, he says by putting them in the same study, it minimizes the impact of any differences, and therefore, you get accurate test of the formulation.

[00:30:02] Speaker 05:
Finally, in Appendix 667, Tevas gave their alternate claim construction.

[00:30:08] Speaker 05:
And Bergstrom says, the only reasonable construction of this limitation is that the plasma concentration of both dosage forms, ER and IR, must be measured in the same study.

[00:30:20] Speaker 00:
And in their brief, they engage this as an alternative.

[00:30:24] Speaker 00:
They proposed that in the district court as an alternative construction.

[00:30:29] Speaker 00:
I don't read this crucial, I guess, was it paragraph 119 on page 671, as going beyond saying,

[00:30:37] Speaker 00:
to get a reliable number for a particular study comparison, you have to put them in the same study.

[00:30:46] Speaker 00:
I don't read that as conceding that if you did studies one through 15, each one with ER and IR in each one, that you would get, in fact, a reliable, reliably stable ratio across

[00:31:02] Speaker 00:
across all of those studies.

[00:31:05] Speaker 00:
What I'm not sure about is whether this issue has actually been litigated.

[00:31:10] Speaker 00:
I don't think it's been considered.

[00:31:11] Speaker 05:
And that's the point on which I'd like to conclude that comment is that that's simply the district court did not consider that alternate construction.

[00:31:22] Speaker 05:
So it hasn't been litigated.

[00:31:24] Speaker 05:
And that's why we suggest and ask for, if not an outright reversal, then a remand to give

[00:31:32] Speaker 05:
the Chief Judge a chance to consider a very important question, which is, if you adopted the construction urged by Teba, would it be indefinite?

[00:31:43] Speaker 05:
I am confident that he would reach the conclusion that it's not indefinite.

[00:31:47] Speaker 05:
But while he had the construction performed, he didn't rule on it.

[00:31:52] Speaker 05:
His opinion doesn't address it.

[00:31:54] Speaker 05:
And I think, candidly, that's what remand is often for.

[00:31:57] Speaker 05:
Thank you, Mr. Papas.

[00:31:58] Speaker 05:
Pardon me?

[00:31:59] Speaker 05:
I think your time has been exceeded.

[00:32:01] Speaker 03:
Exceeded.

[00:32:01] Speaker 01:
We will take the case under advisement.

[00:32:03] Speaker 05:
Thank you.