[00:00:35] Speaker 00:
The next argued case is No.

[00:00:39] Speaker 00:
17-2557, Triss Farmer, Incorporated Against Activist Laboratories.

[00:00:45] Speaker 00:
Mr. Taylor.

[00:00:53] Speaker 06:
Taylor.

[00:00:53] Speaker 06:
Good morning, Your Honor, and may it please the Court.

[00:00:58] Speaker 06:
This appeal is about whether Triss's patents, which claim an unprecedented

[00:01:05] Speaker 06:
between pharmacokinetic properties and clinical effects should have been found obvious when the prior art failed to disclose this relationship and, in fact, thought away from it.

[00:01:20] Speaker 02:
Of those four separate limitations in the claims, are all of them or any of them inherent properties of the formulation?

[00:01:35] Speaker 06:
No.

[00:01:38] Speaker 06:
None of them are inherent properties of the formulation.

[00:01:42] Speaker 06:
The formulations, and if you look at the evidence of activists as experts, Dr. Morton, he testified that he had to do experimentation to get to the pharmacokinetic properties.

[00:01:59] Speaker 06:
There is nothing in the record, and there's certainly no evidence or argument that there was any

[00:02:04] Speaker 06:
from any specific formulation or any formulation at all.

[00:02:08] Speaker 06:
And I know this argument is alluded to for the first time in this appeal in activists' briefs.

[00:02:15] Speaker 06:
But there's no inherency argument in this case.

[00:02:18] Speaker 06:
And the products of the invention are clearly not inherent.

[00:02:25] Speaker 02:
That is a question.

[00:02:27] Speaker 02:
They sort of dance around it.

[00:02:29] Speaker 02:
They sort of imply inherency.

[00:02:31] Speaker 02:
But yet, it was hard for me to find an argument below regarding inherency and hard for me to specify what findings might support such a conclusion.

[00:02:43] Speaker 06:
There was no argument below on inherency and there are no findings in our view that would support such a conclusion.

[00:02:53] Speaker 06:
You know, it was, we saw those words for the first time.

[00:02:58] Speaker 06:
alluded to in the appeal brief, their activist's red brief.

[00:03:04] Speaker 06:
And if you look at the brief, there's no inherency argument, actually, in the paper.

[00:03:09] Speaker 06:
So it's a little bit, in our view, red herring.

[00:03:15] Speaker 06:
But let me get back to a little bit of a discussion about the invention and why I think there are a couple of areas where the court clearly erred and have a clean path.

[00:03:27] Speaker 06:
to reversal.

[00:03:29] Speaker 06:
The claims require what we call an early TMAX.

[00:03:34] Speaker 06:
An early TMAX not in isolation, but an early TMAX in a formulation that results in 12-hour efficacy.

[00:03:44] Speaker 06:
Now, the prior art didn't disclose that.

[00:03:48] Speaker 06:
And in fact, the court below credited Trissa's evidence that the prior art actually tore it away from that.

[00:03:57] Speaker 06:
it taught away from using a formulation that any formulation that had an early T max and the claims require a T max, a time to maximum.

[00:04:10] Speaker 03:
Can you explain what is the benefit, the improved utility in having a T max at say hour four compared to hour five or hour six?

[00:04:21] Speaker 03:
I didn't quite follow what the patient gets out of that.

[00:04:25] Speaker 06:
What the patient gets out of the combination of pharmacokinetic and clinical properties.

[00:04:32] Speaker 03:
I'm just talking about the TMAX right now.

[00:04:36] Speaker 03:
I understand if you can have a single dose for all day, that has value.

[00:04:42] Speaker 03:
If you get a very early onset, that has value.

[00:04:45] Speaker 03:
I understand that.

[00:04:45] Speaker 03:
What I don't understand at the moment is what extra benefit is there in having a TMAX at hour four versus hour five versus hour six versus hour seven.

[00:04:54] Speaker 06:
No pharmacokinetic property like TMAX in isolation provides any individual or specific benefit.

[00:05:05] Speaker 06:
The key to pharmacokinetics as they relate to pharmacodynamics as a clinical property is how that relationship follows.

[00:05:14] Speaker 06:
And what the inventors found in this scenario is that they were able to invent the first liquid product

[00:05:22] Speaker 06:
by using a pharmacokinetic profile that was taught away from in the prior art to result in clinical benefits that were special.

[00:05:34] Speaker 06:
And those clinical benefits are tied to the unique pharmacokinetics.

[00:05:40] Speaker 06:
And that is why we've relied and cited the psychobenzepine case, because we think that precedent is particularly relevant here.

[00:05:49] Speaker 02:
Of course, in that case, there was no known.

[00:05:51] Speaker 02:
PKPD profile for the formulation, whereas here, there were a whole variety of items in the prior art that had certain known profiles, right?

[00:06:04] Speaker 06:
That's correct.

[00:06:05] Speaker 06:
And that, in fact, is why we think this case is even more compelling than Cyclobenzaprin.

[00:06:12] Speaker 06:
In this case, what was known was all over the map.

[00:06:16] Speaker 06:
So far from there being nothing suggesting

[00:06:20] Speaker 06:
a PK profile to get these characteristics.

[00:06:23] Speaker 06:
The prior art actually taught away from the specific profile that the inventors came up with, and specifically the team.

[00:06:35] Speaker 03:
I'm trying to remember this case.

[00:06:37] Speaker 03:
Are you saying that the inventors used the PK profile to get to the clinical effects?

[00:06:44] Speaker 03:
That's not what I recall the story of the invention of ink.

[00:06:49] Speaker 03:
The story of the invention when, you know, mixing IR and ER components and to get the good clinical effects and then characterizing the PK profile and discovering, maybe by happenstance, that it had a single peak and that it had an onset that's relatively early.

[00:07:08] Speaker 03:
Not onset, but a T max that's relatively early.

[00:07:12] Speaker 06:
The story of the invention and, you know, our inventor... And one is remembering something?

[00:07:18] Speaker 06:
Incorrect, Your Honor, but it's not complete.

[00:07:22] Speaker 06:
The story of the invention, to the extent it relates to where the claims are obvious, includes over three years of work towards getting a pharmacokinetic profile that resulted in the clinical effects.

[00:07:36] Speaker 02:
Well, didn't he specifically say they weren't shooting for a single peak?

[00:07:38] Speaker 06:
They absolutely were not shooting for a single peak.

[00:07:41] Speaker 02:
And that was part of what they said was unexpected, right?

[00:07:44] Speaker 06:
Exactly.

[00:07:45] Speaker 02:
So explain why the single peak is important.

[00:07:48] Speaker 02:
Why did the FDA ultimately require the single peak for purposes of bioequivalence?

[00:07:53] Speaker 06:
Why the FDA requires it is because it is unique and it works in this liquid formulation.

[00:08:00] Speaker 06:
You probably noticed in our record, the FDA uniquely for this product

[00:08:05] Speaker 06:
requires the generic companies seeking to copy it to do different and additional pharmacokinetic testing to ensure that they have this profile.

[00:08:17] Speaker 06:
That's unique.

[00:08:18] Speaker 06:
Now, this is something that was not presaged by prior art and was surprising.

[00:08:29] Speaker 06:
And I want the Court to be aware of something that we think is significant.

[00:08:34] Speaker 06:
based on the evidence that was presented by Triss, that it was that the prior art taught away from using this early TMAX, early time to maximum concentration to get a 12-hour efficacy.

[00:08:54] Speaker 06:
And two pages later in the Court's opinion, relying on that same prior, those same prior

[00:09:01] Speaker 06:
The court said, well, those TMAX ranges were known in the prior art.

[00:09:06] Speaker 06:
Well, they were known in the prior art for products that didn't meet the clinical benefits, didn't meet the 12-hour efficacy.

[00:09:16] Speaker 06:
We think it is clear legal error.

[00:09:19] Speaker 03:
Which references are you talking about?

[00:09:20] Speaker 06:
It's the references, the metadata CD.

[00:09:23] Speaker 03:
Has an early TMAX, but doesn't have 12-hour duration?

[00:09:26] Speaker 06:
That's correct.

[00:09:27] Speaker 03:
OK.

[00:09:27] Speaker 06:
And the products that have late

[00:09:29] Speaker 06:
TMAX like focal length, like concerta.

[00:09:35] Speaker 06:
Those are the only ones that resulted in 12-hour efficacy.

[00:09:39] Speaker 03:
Now, the court then- Doesn't Zizinski teach figure 7, 12-hour duration, and then he discloses a TMAX of something like 5.5 to 7.5, which would overlap with your claimed range of a TMAX?

[00:09:55] Speaker 06:
Defendants put a lot in TMAX, in Skosinski.

[00:09:59] Speaker 06:
And Skosinski does not disclose an early TMAX.

[00:10:05] Speaker 03:
It doesn't disclose 5.5 to 7.5?

[00:10:08] Speaker 06:
It does say 5.5 to 7.5.

[00:10:10] Speaker 03:
Doesn't that overlap with your claimed range?

[00:10:13] Speaker 06:
It does at the very end.

[00:10:17] Speaker 06:
Two things.

[00:10:17] Speaker 06:
So it overlaps.

[00:10:19] Speaker 06:
Two things about that, Gerardo.

[00:10:20] Speaker 06:
First, overlap is not anticipation, and it doesn't necessarily render the

[00:10:25] Speaker 06:
earlier claim obvious.

[00:10:27] Speaker 06:
But what's more important is that, first of all, defendants didn't argue below that this Kaczynski reference had the early TMAX.

[00:10:39] Speaker 03:
It's in the record, and I thought you said that there's nothing in the record that teaches something with a 12-hour duration and a TMAX that's in your range.

[00:10:49] Speaker 06:
Well, Kaczynski was testified to by Strawn, their expert,

[00:10:54] Speaker 06:
And he agreed that it doesn't teach within the range.

[00:11:00] Speaker 06:
It does not.

[00:11:00] Speaker 06:
And if you look at the Skaczynski disclosure, it says five and a half to seven and a half.

[00:11:06] Speaker 06:
But that's for a duration that's less than 12 hours.

[00:11:10] Speaker 06:
When it talks about a product that has a 12-hour duration, it says six to seven hours Tmax.

[00:11:20] Speaker 06:
And that's right in this Kaczynski reference.

[00:11:22] Speaker 03:
It says less than 12 hours?

[00:11:24] Speaker 03:
Or does it say 11 to 12 hours?

[00:11:25] Speaker 06:
It says 11 to 12 hours.

[00:11:26] Speaker 03:
OK.

[00:11:27] Speaker 03:
So that's 12 hours, then, if it's 11 to 12 hours.

[00:11:30] Speaker 06:
The testimony below by all of the experts, including Dr. Strawn, was that that reference suggests 5 to 7.5 T max with an 11 to 12 hour duration.

[00:11:44] Speaker 03:
In Kaczynski, it doesn't mean 11 to 12 hour duration.

[00:11:49] Speaker 06:
testimony by all of the experts was that that would have led someone to a T max of six or above if they wanted to.

[00:11:59] Speaker 02:
So are you saying that Skaczynski disclosed two different things, one with a one T max to 5.5 to 7.5 with a low shorter duration and one with a longer duration but a different T max?

[00:12:14] Speaker 06:
Skaczynski discloses

[00:12:17] Speaker 06:
that you can use a range from five and a half to seven point and a half.

[00:12:23] Speaker 06:
And then it says, for that range, you can get a duration of 11 to 12 hours.

[00:12:32] Speaker 06:
It goes on into virtually the next sentence when it's talking about a product that is more germane to this invention, a product that has early onset, one and one and a half hours, and it has 12 hour

[00:12:45] Speaker 06:
12- to 14-hour efficacy, it says to use 6- to 7-hour TMAX.

[00:12:50] Speaker 02:
Assuming we find an overlap in both TMAX and the duration, what else would be missing from Skazinski?

[00:12:59] Speaker 06:
Well, Skazinski doesn't disclose that the product has early onset, as claimed in the PAT.

[00:13:07] Speaker 06:
Skazinski, of course, you certainly realize from our brief, is a hypothetical.

[00:13:14] Speaker 06:
It's based on no data.

[00:13:16] Speaker 06:
It was clearly a prophetic disclosure and patent.

[00:13:21] Speaker 06:
It's a patent application never issued as a patent.

[00:13:25] Speaker 02:
And it's not as clear that it's an accurate solution, right?

[00:13:29] Speaker 06:
It's not a solution.

[00:13:30] Speaker 06:
It is a solid product.

[00:13:31] Speaker 06:
And so Skazinski, the inventors, could have just said anything they want about the properties of their product.

[00:13:39] Speaker 06:
They only aspired to a product that had, in our view, a late TMAX.

[00:13:44] Speaker 06:
And it didn't even aspire to the early onset as claimed in the invention.

[00:13:51] Speaker 06:
So even if you assume that the pharmacokinetics of the solid products disclosed in Skazinski could be applied to a liquid, and there's nothing in there that says it could be, even if you assume that and you had the formulator attempt to make that Skazinski

[00:14:13] Speaker 06:
pharmacokinetics, and even if you assume that the Skaczynski pharmacokinetics in a liquid product would come to the same clinical activity, it still doesn't lead to the claims.

[00:14:31] Speaker 06:
Skaczynski does not disclose the early onset that is claimed.

[00:14:36] Speaker 00:
So you have to go through it.

[00:14:37] Speaker 00:
If you make that assumption, then you lead

[00:14:42] Speaker 00:
the arguments which you have to rely on in order to preserve validity?

[00:14:49] Speaker 00:
Will you say, even if you assume that this was already known, as I think perhaps we must assume?

[00:15:00] Speaker 06:
Well, we don't believe that Skaczynski, in our brief, that we think it's clearly erroneous for the court to find that Skaczynski even disclosed a single

[00:15:12] Speaker 06:
mean peak.

[00:15:14] Speaker 06:
But even accepting that it did and accepting everything in Skazinski, it doesn't lead to the invention.

[00:15:23] Speaker 06:
Even accepting that the pharmacokinetic, pharmacodynamic, or clinical relationship in Skazinski could be applied to a different formulation and a liquid.

[00:15:35] Speaker 06:
There's absolutely no testimony on that to making that key connection.

[00:15:40] Speaker 06:
But even if you assumed all of that,

[00:15:42] Speaker 06:
Skazinski doesn't get you to the early onset.

[00:15:45] Speaker 06:
Where in the record is the suggestion that someone would modify Skazinski in a way to get to the early onset that's claimed in the patent?

[00:15:56] Speaker 06:
Well, if you look at the pharmacokinetics of what was known in the prior art, it was all over the place.

[00:16:03] Speaker 06:
The pharmacokinetics of the products of the invention are unique.

[00:16:09] Speaker 06:
For any product,

[00:16:10] Speaker 06:
But it's the first liquid formulation.

[00:16:13] Speaker 06:
There was nothing out there on a liquid, long-acting formulation.

[00:16:19] Speaker 06:
So to look at hindsight, as we believe the defendants did, to say, well, let's pick the pharmacokinetics, the TMAX from these two products.

[00:16:31] Speaker 06:
Let's choose the 12-hour efficacy from these other products and say, well, it was routine experimentation.

[00:16:40] Speaker 06:
for someone to put it all together, I think it's the definition of hindsight.

[00:16:45] Speaker 06:
And again, if you look at what the court actually found, based on the prior ARC, it's that it's taught away.

[00:16:54] Speaker 06:
Now, how do you find that references in prior ARC that teach away from the claimed key feature, TMAX, and late onset, single mean peak,

[00:17:08] Speaker 06:
early activity and 12-hour onset.

[00:17:10] Speaker 06:
How do you find that those same references lead to obviousness without clear persuasive evidence tying those particular references to the claimed features?

[00:17:24] Speaker 06:
And here, the claimed feature is a pharmacokinetic, pharmacodynamic, pharmacokinetic clinical relationship.

[00:17:36] Speaker 06:
The only evidence on that relationship was presented by Tris experts.

[00:17:43] Speaker 06:
And that is the evidence that the court relied on to find teaching away.

[00:17:49] Speaker 02:
You're not claiming the PD was not known in the prior art, right?

[00:17:54] Speaker 02:
Just the connection between the two.

[00:17:57] Speaker 06:
Well, it all depends on what you consider known in the prior art.

[00:18:01] Speaker 06:
There's no product in the prior art that had the combination

[00:18:06] Speaker 06:
of 45-minute onset of activity in 12-hour efficacy.

[00:18:11] Speaker 06:
You can look at all the prior art, whether it's solid, patch, whatever.

[00:18:17] Speaker 06:
There was nothing.

[00:18:18] Speaker 06:
And of course, none of these had been applied to a liquid.

[00:18:23] Speaker 06:
And I think it's, you know, to get on to unexpected results, it is notable that

[00:18:33] Speaker 06:
Methylphenidate had been used in conserter and other products for 50 years.

[00:18:40] Speaker 06:
There was an acknowledged need for a long acting liquid product.

[00:18:47] Speaker 06:
If it was so obvious, was so clear from what was known about the pharmacokinetics, why wasn't it done before?

[00:18:55] Speaker 06:
And so when you look at the prior arc,

[00:19:02] Speaker 06:
And I'm over my time.

[00:19:04] Speaker 00:
Yes, you are.

[00:19:07] Speaker 00:
You've made some interesting points that I will ask your friend to thank you.

[00:19:12] Speaker 00:
We'll save some rebuttal time.

[00:19:13] Speaker 06:
Great.

[00:19:14] Speaker 06:
Thank you.

[00:19:21] Speaker 00:
Mr. Jay, I was particularly interested to hear the argument that there's been no product in the prior art that's combined these two

[00:19:32] Speaker 00:
kinds of components?

[00:19:35] Speaker 04:
Good morning, Your Honor.

[00:19:36] Speaker 04:
And thank you for starting me there, because I think that it's important to begin just there.

[00:19:40] Speaker 04:
The idea that there has been no product with a 45-minute onset and a long-acting duration, that's right in the teeth of the findings that the district court made.

[00:19:51] Speaker 04:
And I think that as this court considers it, under the clear error standard, those findings are not clearly erroneous.

[00:19:57] Speaker 02:
Which product?

[00:19:58] Speaker 04:
Concerta, Your Honor.

[00:20:01] Speaker 04:
Once we've finished talking about concerto, I'd like to also come back to Susinski, which admittedly is not commercialized, but is certainly in the prior art.

[00:20:10] Speaker 03:
Right, I think the claims here, they don't just have two requirements, early onset and 12-hour duration.

[00:20:15] Speaker 03:
They all have 12-hour duration and then plus these PK profiles and things like this.

[00:20:22] Speaker 03:
So that's the challenge, being able to

[00:20:25] Speaker 03:
put together a rationale for why it would have been so obvious with a reasonable expectation of success to have all of these different features as part of the claim.

[00:20:34] Speaker 04:
Sure.

[00:20:35] Speaker 04:
I understand that.

[00:20:35] Speaker 04:
I took Judge Newman to be asking the question where my friend had just left off about the idea that there is no product with these actual clinical benefits.

[00:20:44] Speaker 02:
But the district court made no finding with respect to the onset of four concerta.

[00:20:49] Speaker 02:
And there is a dispute between the parties on that.

[00:20:51] Speaker 02:
You say 30 minutes to two hours.

[00:20:55] Speaker 02:
Your friend on the other side says two hours.

[00:20:58] Speaker 02:
District court made no finding.

[00:20:59] Speaker 04:
I don't agree with that, Your Honor.

[00:21:00] Speaker 04:
I would point you to page 47 of the appendix where the district court says the prior art disclosed and Dr. McGough conceded that the second-generation products have onset of action in as early as 30 minutes.

[00:21:13] Speaker 04:
That's the products, not just Szyzynski.

[00:21:15] Speaker 04:
And then the citation is to JTX 19 at 2.

[00:21:19] Speaker 04:
And that is the Biederman reference that the other side's expert had to say was mistaken.

[00:21:26] Speaker 04:
The district court quite properly concluded that when a litigation expert says that a piece of published prior art is mistaken,

[00:21:32] Speaker 04:
The court doesn't have to credit the litigation expert.

[00:21:35] Speaker 03:
So what are we supposed to do with the fact that you're pointing to the secondary consideration section of this opinion, where when we look at the front part of the analysis, it doesn't talk about Beardman.

[00:21:48] Speaker 03:
It just talks in broad generalities of how it was known to have something with early onset and long duration without actually

[00:21:59] Speaker 03:
scoping down to the specifics of what's claimed, which is 12 hours and 45 minutes.

[00:22:05] Speaker 04:
I don't think that that's... I think that the reason that the district court doesn't... makes this finding on page 47 instead of earlier is that it... the court had rejected the idea that a single peak product would teach away from early onset by using Szyzynski, which of course is not a commercial product.

[00:22:25] Speaker 04:
So it doesn't start talking about the commercial products until it is talking about the secondary considerations.

[00:22:30] Speaker 04:
But it certainly is making a finding based on the very evidence, the very factual and expert dispute that the parties had raised.

[00:22:39] Speaker 02:
The other side had said- How do we deal with the finding of teaching way with this apparently contrary statement?

[00:22:47] Speaker 02:
How do we decide what exactly the district court found?

[00:22:51] Speaker 04:
I don't think that there's any way to read the district court's decision to, as my friends read it, to as a finding of teaching away based on single peak, which is where the discussion is, or on TMAX, because the district court, I think, makes a couple of important findings.

[00:23:08] Speaker 04:
One,

[00:23:09] Speaker 04:
the Court on, in discussing Cieszynski, specifically says that Cieszynski teaches toward a single peak.

[00:23:16] Speaker 04:
That's at page 41.

[00:23:17] Speaker 04:
That's not compatible with the, with the notion that two pages before the district court has found teaching away.

[00:23:23] Speaker 04:
All the district court said was that the, that the, it had found some things persuasive about the other side's evidence about the commercial products, the second-generation products.

[00:23:33] Speaker 04:
But it then goes on to discuss the remainder of the prior art.

[00:23:36] Speaker 04:
And in, and in finishing that discussion, it says,

[00:23:39] Speaker 04:
that Szyzynski teaches toward a single peak.

[00:23:41] Speaker 04:
The other side's argument is that the prior art taught away from a single peak.

[00:23:46] Speaker 03:
Go ahead.

[00:23:46] Speaker 03:
OK.

[00:23:47] Speaker 03:
I guess here's my concern, which is there is this debate isolated down to whether you could achieve a single peak, where the real argument needs to be, can you achieve a single peak while also having 45-minute onset and 12-hour duration all at the same time?

[00:24:07] Speaker 03:
And the counter argument to that is, well, in order to get that very early onset, you need a lot of immediate release components.

[00:24:14] Speaker 03:
In order to get the all-day effect, you need those sustained release components.

[00:24:21] Speaker 03:
And so when you have a bunch of immediate release components combined with a bunch of extended release components,

[00:24:27] Speaker 03:
What are you going to get on your graph?

[00:24:28] Speaker 03:
You're actually going to get two peaks.

[00:24:30] Speaker 03:
You're not going to get a smooth single peak.

[00:24:33] Speaker 03:
And so then the challenge is, well, then how are you really going to expect to get all three of the claim features, i.e., 45-minute early onset, single peak, with 12-hour duration?

[00:24:45] Speaker 03:
And that was the concern I had in trying to understand this district court's opinion as to why one would expect all of that when the analysis is that the single peak

[00:24:55] Speaker 03:
is really just to the single question in isolation without considering it in combination with the other two claimed elements.

[00:25:01] Speaker 04:
Sure.

[00:25:01] Speaker 04:
Now, of course, as Your Honor's questions to my friend have brought out, Sosinski includes, at the very least, the durational component as well.

[00:25:13] Speaker 04:
But let's talk about the three elements in combination.

[00:25:17] Speaker 04:
And this is an extended release product.

[00:25:19] Speaker 04:
And one of the most important findings that the district court made and one of the most important things to understand about the extended release product

[00:25:25] Speaker 04:
Because it is made of a combination of immediate release and extended release beads, is that what matters for the clinical effect, both the early onset and the duration of action, is not the Tmax, it's the combination, it's the ratio of immediate release beads to... But a Tmax is one of the claim limitations.

[00:25:44] Speaker 04:
That's correct, Your Honor.

[00:25:45] Speaker 01:
You can't ignore a claim limitation.

[00:25:47] Speaker 04:
We are not asking you to ignore the claim limitation, but it is stipulated in this case that there's a motivation to make the product with early onset and extended duration, stipulated.

[00:25:59] Speaker 02:
The findings, I think, show why there's... But there's no findings of motivation to put all of these limitations together.

[00:26:09] Speaker 02:
It seems to me that there was what we've always said is not appropriate, which is you can't just pick and choose and find pieces.

[00:26:16] Speaker 02:
in the prior art and say therefore it's all there.

[00:26:19] Speaker 02:
You have to have a motivation to put them all together.

[00:26:21] Speaker 04:
You do, Your Honor, but where you have a motivation to combine the prior art to, in this case, to achieve certain clinical results, early onset and extended duration, which are two of the claim limitations, from there, because the evidence shows that, as my friend conceded this morning, that

[00:26:41] Speaker 04:
shape of the curve, for example, has no therapeutic significance at all.

[00:26:46] Speaker 04:
Well, but the FDA requires that curve, right?

[00:26:49] Speaker 04:
Requires a single peak.

[00:26:51] Speaker 04:
I don't agree with that, Your Honor.

[00:26:52] Speaker 04:
And I believe that, and this is more relevant to the infringement issue that the district court did not decide, but I believe the evidence shows that the other side had told the FDA the equivalent has two peaks.

[00:27:04] Speaker 04:
But in any event, we think that the

[00:27:11] Speaker 04:
that both the number of peaks and the TMAX in this case go to what this Court has inquired in cases like Parr v. TWI.

[00:27:21] Speaker 04:
Are these suitable options once you have the motivation to combine the prior art?

[00:27:27] Speaker 04:
Because the TMAX has no therapeutic significance, for example, or the if you've achieved early onset and extended duration, because the number of peaks in the curve has no therapeutic significance.

[00:27:39] Speaker 02:
But the claim, it's significant to the claim.

[00:27:41] Speaker 02:
It is significant to the claim.

[00:27:43] Speaker 02:
So you seem to be dancing around an inherency argument, but you never made an inherency argument below.

[00:27:48] Speaker 04:
We did not.

[00:27:49] Speaker 04:
I'm making a suitability argument based on cases like Parr, like Bayer versus Watson.

[00:27:54] Speaker 04:
for example, in which it doesn't matter whether the combination achieves the, where there are multiple ways of achieving a combination, it doesn't matter whether it is the best option.

[00:28:07] Speaker 04:
What matters is whether it is, whether a combination with all the claim limitations is a suitable option unless there is a teaching away.

[00:28:15] Speaker 04:
And that is why the question whether there is a teaching away from a single peak is so important.

[00:28:19] Speaker 03:
Let me see if I can unpack this a little bit.

[00:28:20] Speaker 03:
I take your argument to being that because there's no evidence that a single peak matters versus two peaks or maybe a shoulder and then a single peak that it'd be obvious to have any of those types of PK profiles and then it's just a matter of selecting one over the other.

[00:28:39] Speaker 03:
But there's still, at the bottom then, has to be a reasonable expectation of success that you could achieve any one of those PK profiles.

[00:28:47] Speaker 03:
Now, the patent owner is making an argument that nobody would have expected that you could have been able to achieve a single profile, given the requirements of having 12-hour duration and a very early onset.

[00:29:00] Speaker 03:
And that is the question that

[00:29:02] Speaker 03:
I was looking for an answer to in the district court's opinion, and that's my concern right now.

[00:29:08] Speaker 03:
Where would it have been, where's the evidence for why ex ante one would have expected reasonably that you could have achieved a single peak?

[00:29:19] Speaker 04:
The evidence is the evidence that was submitted on the question of acute tolerance or tachyphylaxis, which was the way, the emphasis that the other side placed on the PK profile in the district court.

[00:29:32] Speaker 04:
The question was whether you could, you would expect to see some falling off based on a single peak profile.

[00:29:40] Speaker 04:
And the, and the, in other words, you wouldn't be able to achieve the long-term efficacy over the 12 hours because you'd see some falling off.

[00:29:48] Speaker 04:
And the other side's expert admitted when confronted with Figure 1 from Swanson that what matters is not whether there's a single peak, but whether there is a flat

[00:29:59] Speaker 04:
P.K.

[00:30:01] Speaker 03:
Let me drill down a little bit more.

[00:30:03] Speaker 03:
My concern right now is what

[00:30:08] Speaker 03:
is the content of the district court's opinion.

[00:30:10] Speaker 03:
As I understand right now, unless you can show me otherwise, the district court's opinion doesn't address the acute tolerance theory in the analysis section.

[00:30:21] Speaker 03:
And then it seems to just assume that if you can make a single peak, then the 45-minute onset and the 12-hour duration would be

[00:30:29] Speaker 03:
unaffected by just doing a deconvolution or some kind of ratio next to figure out a way to get a smooth single curve the 45 minute onset and the 12 hour duration would stick in place and not move and and I'm concerned about why that is so you might be able to dig through the appendix and show me

[00:30:53] Speaker 03:
pieces of testimony that support that kind of conclusion, but I don't see it in the district court's opinion.

[00:31:00] Speaker 03:
And that's what I'm afraid of in terms of whether to affirm this based on the lack of addressing acute tolerance and the lack of really explaining why you can get a single peak while still preserving 45 minutes and 12 hour duration.

[00:31:16] Speaker 04:
And I think that the reason that you should not have any reservations about affirming that on the acute tolerance point is because the on the key point, there's an admission from the other side's expert, which I believe the district court credits, although I don't have the page number right in front of me at the moment where the court does that.

[00:31:36] Speaker 04:
But where the admission is is at page 2267 of the appendix, you know, where Dr. McGough, the other side's expert, says that, you know, each paper

[00:31:47] Speaker 04:
Each paper on which he relied stated that the acute tolerance theory is based on a sustained flat plasma concentration.

[00:31:54] Speaker 04:
So in other words, the idea that basing the teaching away argument on the idea that a single peak would lead to tachyphylaxis, would lead to acute tolerance, would prevent you from accomplishing that efficacy over the course of the 12 hour day.

[00:32:14] Speaker 04:
That does not come from the single peak on the curve.

[00:32:18] Speaker 04:
It comes from the shape of the curve and the court.

[00:32:21] Speaker 02:
But are you saying that we should then look at some things in the record that you want to point to to conclude that the district court was wrong in its teaching away finding?

[00:32:31] Speaker 04:
Your Honor, I respectfully don't accept the premise that the court made a teaching away finding.

[00:32:36] Speaker 04:
And perhaps we have to disagree about that.

[00:32:39] Speaker 04:
But I'd like to try to convince you that at the bottom of page 39 where the court

[00:32:44] Speaker 04:
refers to the second generation commercial products and says that some of the other side's evidence on that is persuasive.

[00:32:53] Speaker 04:
I don't think that the court is thereby making a finding that all of the things it has said to date are the arguments that Tris was making.

[00:33:01] Speaker 04:
are hereby accepted by the court and given the status of factual findings.

[00:33:05] Speaker 04:
That's not how we read page 39 of the appendix.

[00:33:08] Speaker 04:
And we don't think that you can read it that way.

[00:33:10] Speaker 04:
And just to give you one example, Triss said teach away.

[00:33:15] Speaker 04:
But then at page 46, the court says that these same products show that a single peak product could provide for rapid onset and extended duration.

[00:33:24] Speaker 04:
The court can't have accepted Tris's arguments, and we don't think that that's the correct way to read the statement.

[00:33:29] Speaker 03:
Do you think the district court meant at the bottom of A39 when it says the court believes Tris's evidence regarding the secondary generation products is persuasive?

[00:33:37] Speaker 03:
What pieces, because obviously you're looking to back out some of Tris's evidence and arguments that the district court found persuasive, but obviously it found something that Tris presented as being persuasive,

[00:33:50] Speaker 03:
What pieces, in your view, did the district court find to be persuasive?

[00:33:57] Speaker 04:
Well, at most, Your Honor, it's evidence regarding second-generation products, and that is not the full extent of the prior art.

[00:34:04] Speaker 03:
And the court, you know, in kind of good narrative fashion... Does that translate for me, what about the second-generation products that Chris was arguing, did the district court find persuasive, in your view?

[00:34:16] Speaker 04:
I'm not sure that the court can be said to have credited any particular argument, but it certainly can't have credited any of the arguments.

[00:34:22] Speaker 02:
It lists four or five and then says, I find those to be persuasive.

[00:34:26] Speaker 04:
I don't think that's what the Court says, Your Honor, respectfully.

[00:34:28] Speaker 04:
The Court says, well, the Court believes Tris's evidence regarding the second-generation products is persuasive.

[00:34:32] Speaker 04:
It's not dispositive.

[00:34:34] Speaker 04:
And so two things about that.

[00:34:35] Speaker 04:
One, the Court goes on for the next two paragraphs to discuss the Szyzynski reference, which is not a second-generation product, because it was not commercialized, but which is nonetheless in the prior art.

[00:34:47] Speaker 04:
And the Court obviously gave considerable weight to Szyzynski, despite the other side's evidence, attempts to discredit it.

[00:34:53] Speaker 04:
The Court considers that.

[00:34:56] Speaker 04:
you know, weighs the competing expert testimony and makes a factual finding that Sissinsky teaches toward, not away from, a single peak at the top of 41.

[00:35:06] Speaker 04:
And then, you know, again, all throughout the pages 45 to 46, and I believe on to 47,

[00:35:13] Speaker 04:
where the court makes additional findings about the second-generation products specifically, the court can't have credited all of Tris's arguments about teaching away and made the same findings that it made about unexpected results and long-felt need.

[00:35:28] Speaker 02:
Well, your time is up, but can I ask a question?

[00:35:32] Speaker 02:
Unexpected results.

[00:35:33] Speaker 02:
I was really troubled by the whole notion that this credits all of the testimony.

[00:35:40] Speaker 02:
And the basis is,

[00:35:42] Speaker 02:
you know, that the expert supposedly said he didn't know what the closest prior art was.

[00:35:49] Speaker 02:
But the point that the expert was making, as I read it, is that there are four separate limitations, and while the closest prior art on one limitation might be X, it depends on which limitation you're talking about and which factor you're talking about to decide what the closest prior art is.

[00:36:07] Speaker 02:
And so instead of

[00:36:08] Speaker 02:
saying, okay, well, that might go to the weight of his testimony.

[00:36:12] Speaker 02:
He just rejects all of it out of hand.

[00:36:14] Speaker 02:
I don't understand how he could do that.

[00:36:15] Speaker 04:
Well, but of course, Your Honor, the Court then, in the next paragraph, the carryover paragraph from 45 to 46, takes on the argument on its own terms and considers Tris's arguments and concludes that there is not an unexpected result.

[00:36:27] Speaker 04:
So, you know, comparing, proceeds to do the comparison after having made this methodological point.

[00:36:32] Speaker 02:
The frustration here is the findings are all over the map.

[00:36:35] Speaker 02:
You want us to pick and choose findings.

[00:36:38] Speaker 02:
They want us to pick and choose findings.

[00:36:40] Speaker 02:
And yet, what we need is a roadmap that has findings that are clear and lead in one direction.

[00:36:46] Speaker 04:
But respectfully, I would submit, Your Honor, that in this case, we've cited a number of findings that go to specific pieces of prior art, that go to specific disputes between experts, all of which the district court resolved in our favor.

[00:36:59] Speaker 04:
The other side has cited one finding, and we don't agree that it's a finding, but the one thing that they cite from the district court that they agree with, and in their reply brief they characterize it as a finding and ask you to defer to it, it's that difficult to understand statement at the bottom of 39.

[00:37:14] Speaker 04:
We think that I candidly concede that it is difficult to understand if you look only at that paragraph, but seen in context

[00:37:22] Speaker 04:
If reading the next couple of paragraphs and reading all of the actual specific findings on which we've relied, I don't think that you can read the district court to have, you know, abruptly credited a large portion of Tris's case in this one kind of half a sentence.

[00:37:36] Speaker 04:
So we agree that this court wants benefits from

[00:37:41] Speaker 04:
clear and detailed factual findings on these points, but we submit that the key findings in this case, some of them have not even been appealed, such as the findings that a liquid methylphenidate product is obvious.

[00:37:53] Speaker 03:
I'm sorry to interrupt you, but before you go, where did the district court talk about why one would have a reasonable expectation of having an early TMAX with a 12-hour duration?

[00:38:07] Speaker 03:
I didn't see that in the opinion.

[00:38:09] Speaker 04:
It comes from the ratio, Your Honor.

[00:38:11] Speaker 04:
So the testimony is at 2164 and 2172.

[00:38:14] Speaker 04:
I'm sorry.

[00:38:15] Speaker 03:
I'm on the page of the district court's opinion.

[00:38:18] Speaker 04:
I would put you first to 41 and then to 43, Your Honor.

[00:38:22] Speaker 03:
So 41 was talking about T-max and half-life.

[00:38:27] Speaker 03:
And so I just want, are you suggesting that I should be thinking of half-life as a stand-in for duration?

[00:38:36] Speaker 04:
No, Your Honor.

[00:38:37] Speaker 04:
They're distinct.

[00:38:37] Speaker 04:
But you'll see that the Court goes on to discuss the T-max range and then the half-life range separately.

[00:38:45] Speaker 03:
Right.

[00:38:45] Speaker 03:
But the argument, as I understand it from the other side, is it was unexpected that you could achieve

[00:38:51] Speaker 03:
12-hour duration while having an early TMAX.

[00:38:55] Speaker 03:
And that was surprising.

[00:38:57] Speaker 03:
And that would not be reasonably expected ex ante when you're designing a drug that is, among other things, to get a 12-hour duration.

[00:39:09] Speaker 04:
Right.

[00:39:10] Speaker 04:
So I would point you to the sentence that begins with lastly.

[00:39:13] Speaker 04:
Lastly, Dr. Strawn expected that a POSA would not have targeted a specific TMAX or half-life because those parameters do not control the onset or duration of effect.

[00:39:20] Speaker 04:
And if you look at the two testimony pages that are cited there, so he cites 380 and 377, and that translates into, I believe, 2164, 2172.

[00:39:30] Speaker 04:
What our expert, Dr. Strawn, the only PKPD expert to testify on in validity, what he says on this subject is that for an extended release product,

[00:39:44] Speaker 04:
It's the ratio, the ratio of immediate release to extended release beads in the product that controls the duration of action, not the Tmax.

[00:39:53] Speaker 04:
So the Tmax is incidental.

[00:39:55] Speaker 04:
Once you've formulated the product, you can look at what the curve looks like.

[00:40:01] Speaker 04:
But the curve and the Tmax of that curve are a function of the ratio.

[00:40:05] Speaker 04:
The ratio is what the formulators would have drawn from the prior art.

[00:40:08] Speaker 04:
The ratio is drawn from the range of

[00:40:12] Speaker 04:
uh, you know, the narrow band of, of the, uh, identified by the experts from the prior art.

[00:40:17] Speaker 04:
That's how you figure out what to use.

[00:40:20] Speaker 04:
And I, in the context of an extended release product, the TMAX here has no therapeutic significance.

[00:40:26] Speaker 04:
It is incidental.

[00:40:26] Speaker 04:
And that's why I would go back to the PAR versus TWI case.

[00:40:30] Speaker 04:
Uh, a TMAX within this range is a suitable way of achieving the goal.

[00:40:35] Speaker 04:
This, you know, the goal that everyone stipulates there's a, there's a motivation to pursue.

[00:40:40] Speaker 04:
early onset and extended duration.

[00:40:43] Speaker 03:
But do you agree that there has to be a reasonable expectation of being, in addition, for the purposes of this claim for obviousness, to also get an early TMAX?

[00:40:52] Speaker 04:
Yes.

[00:40:52] Speaker 04:
And the court, in that sentence that I've read, I think the court is agreeing with our expert's conclusion that in the context of extended release, it is the ratio and not the TMAX that determines how long the response lasts.

[00:41:05] Speaker 04:
I mean, the other side had been arguing that, in general, it's the TMAX that determines it.

[00:41:10] Speaker 04:
And what the court says, what our expert says, this is at 2101, is that that may be a rule of thumb for many products, but for extended, extended release products are an exception to that rule of thumb.

[00:41:19] Speaker 00:
You look at the ratio.

[00:41:20] Speaker 00:
Isn't that the problem?

[00:41:22] Speaker 00:
That until you do it, you don't know.

[00:41:25] Speaker 00:
And if it is this unusual to combine immediate and extended release, how do you know it's going to work until you do it?

[00:41:35] Speaker 04:
Well, but respectfully, Your Honor, it's not at all unusual to combine immediate and extended release.

[00:41:39] Speaker 04:
That's how each of these prior art second generation products works.

[00:41:44] Speaker 04:
Each of them is an extended release that combines some immediate release and some extended release.

[00:41:49] Speaker 04:
And the way that our expert approached this is to look at the ratios from the relevant prior art products and to explain where a formulator would put the ratio using the teachings of that prior art.

[00:42:05] Speaker 04:
I mean, there are elements of these claims that go to the ratio between immediate and extended release.

[00:42:11] Speaker 04:
But the other side is not arguing that the ratio is itself inventive or that the selection of the ratio is what separates these claims from the prior art and makes them patentable.

[00:42:21] Speaker 04:
That's not an argument they're making at all.

[00:42:23] Speaker 04:
And once you have determined the ratio based on the teachings of the prior art and the onset and duration that you want to achieve, the TMAX follows from that within a range.

[00:42:34] Speaker 00:
OK.

[00:42:35] Speaker 00:
Thank you.

[00:42:36] Speaker 04:
Thank you very much, Your Honor.

[00:42:38] Speaker 00:
Let's see.

[00:42:38] Speaker 00:
We've run out of Mr. Taylor.

[00:42:40] Speaker 00:
I think six minutes.

[00:42:46] Speaker 06:
Thank you, Your Honor.

[00:42:48] Speaker 06:
I want to address first this issue about the ratio.

[00:42:53] Speaker 06:
Yes.

[00:42:55] Speaker 06:
And this gets to the kind of fundamental error that I think the court was led to.

[00:43:04] Speaker 06:
by the way obviousness was argued below.

[00:43:09] Speaker 06:
There is a huge difference between finding a formulation that has a particular set of pharmacokinetic parameters and evidence that a certain set of pharmacokinetic parameters will provide a certain clinical profile.

[00:43:34] Speaker 06:
Now, this question of ratios, there was some testimony by activists' formulation expert that you could use a whole host of range of ratios to tailor your product to get certain TMAX values.

[00:43:51] Speaker 06:
And he looked at products in the prior art, including concerta and metadata.

[00:43:58] Speaker 06:
Now, if you look at those products, the PK,

[00:44:03] Speaker 06:
profiles from those products, with almost the same ratios, they look very different.

[00:44:10] Speaker 06:
And their properties are very different.

[00:44:12] Speaker 06:
So it's not just a matter of ratios that will get you to the claimed invention.

[00:44:20] Speaker 06:
What the inventors found was that there was a particular set of pharmacokinetic properties when applied to its liquid formulation.

[00:44:32] Speaker 06:
that resulted in a unique and beneficial set of clinical properties.

[00:44:40] Speaker 06:
That's not in the prior art, and there is no suggestion in the prior art of getting to those claimed pharmacokinetic clinical profiles.

[00:44:53] Speaker 06:
It's just not there.

[00:44:54] Speaker 03:
And- CERDA has something that's close to a single peach, right?

[00:44:58] Speaker 03:
It's got a little shoulder there, and then it's got the big peach.

[00:45:02] Speaker 06:
Yeah, close to a single peak in our view is not a single peak.

[00:45:05] Speaker 06:
Close to a single peak.

[00:45:06] Speaker 03:
That's fine, but I wouldn't go so far as I think you did to say it's completely different.

[00:45:12] Speaker 03:
Concerta.

[00:45:12] Speaker 03:
The district court found it's very close, and because it's so close, it would be actually pretty routine to optimize if you wanted to, to have a single peak.

[00:45:21] Speaker 03:
That's what I understand the district court.

[00:45:22] Speaker 06:
Yeah, and it's, again, one of the errors that the court, I believe, was also led to.

[00:45:28] Speaker 06:
Concerta doesn't have the TMAX.

[00:45:32] Speaker 06:
that is claimed.

[00:45:34] Speaker 06:
It wasn't even argued to have the claimed TMAX.

[00:45:38] Speaker 06:
So even if you accept that Concerta is a product that has a single mean peak, it has a late TMAX, which is what the prior art would have expected.

[00:45:49] Speaker 06:
You want to get a late long activity, you do.

[00:45:52] Speaker 02:
What's your response to the argument that the TMAX isn't really important to the clinical value?

[00:46:00] Speaker 06:
I would agree with you, Your Honor, that you don't read claim limitations that you have a problem meeting by an argument that they're not important.

[00:46:10] Speaker 06:
They are important to this invention, and that's why I made the point of citing to the FDA change in its procedures to have a three-characteristic pharmacokinetic disclosure that ensures that the generic products who copy this

[00:46:30] Speaker 06:
product have the same profile.

[00:46:33] Speaker 06:
And with this product, the TMAX is important.

[00:46:37] Speaker 06:
Now, TMAX by itself, sure, there are ways that formulators can get to a TMAX.

[00:46:46] Speaker 06:
But what do we know about from the prior art about TMAX?

[00:46:50] Speaker 06:
The later the TMAX, generally the longer the activity.

[00:46:58] Speaker 06:
It's what

[00:46:59] Speaker 06:
was expected and what was shown by the prior art.

[00:47:02] Speaker 03:
Well, that's a contested fact below, right?

[00:47:05] Speaker 03:
That's obviously your argument, but the other side's argument is that there wasn't really a proven connection between TMAX and duration.

[00:47:13] Speaker 06:
Actually, that's not contested.

[00:47:14] Speaker 06:
Every expert agreed that, you know, generally later TMAX results in later efficacy.

[00:47:22] Speaker 06:
There is a disagreement as to this whether, you know, someone would go to a single mean peak.

[00:47:29] Speaker 06:
and whether the prior art would have torn away from going to a single peak.

[00:47:34] Speaker 03:
But there's no.

[00:47:35] Speaker 03:
Dr. Strawn didn't say TMAX has no effect on duration?

[00:47:39] Speaker 06:
I believe what Dr. Strawn said is that a formulator, a scientist wouldn't focus on the TMAX.

[00:47:47] Speaker 06:
TMAX absolutely doesn't.

[00:47:49] Speaker 06:
Because it doesn't have an impact on duration.

[00:47:52] Speaker 06:
Well, I don't believe that Dr. Strawn said that.

[00:47:56] Speaker 06:
And that would, of course, is at odds with what the court

[00:47:59] Speaker 06:
what court found.

[00:48:01] Speaker 02:
Do you agree with your friend on the other side that there was no dispute but that Concerta had the early onset?

[00:48:07] Speaker 06:
There's absolutely a dispute about whether Concerta had an early onset.

[00:48:11] Speaker 06:
Concerta, if you look at the clinical data for Concerta that's in their package insert, it says that the onset is at two hours.

[00:48:21] Speaker 06:
Now, there is this one reference that says, you know, look for it from 30 to 30 minutes to two hours.

[00:48:29] Speaker 06:
Um, but the, the actual data that's in the package insert for concerto says the onset is two hours, but let's assume that it's 30 minutes to two hours.

[00:48:40] Speaker 06:
That's not the same as the claimed limitation of less than 45 hours, 45 minutes, 45 minutes.

[00:48:48] Speaker 03:
It's not the same thing.

[00:48:52] Speaker 06:
30 minutes, if it was, if the reference said activity within 30 minutes, yeah, I would agree with that.

[00:48:59] Speaker 06:
It says 30 minutes to two hours.

[00:49:02] Speaker 06:
The claim requires activity within 45 minutes.

[00:49:07] Speaker 06:
That's not the same thing.

[00:49:08] Speaker 06:
And there was nobody that testified that said it was.

[00:49:12] Speaker 03:
I thought Dr. Bearden did.

[00:49:15] Speaker 06:
No, he said that it was 30.

[00:49:17] Speaker 06:
That was a reference with Biederman.

[00:49:19] Speaker 06:
And that was the reference that our experts said was clearly mistaken.

[00:49:23] Speaker 06:
The reference says, you know, in a table for concerto without any data, without any reliance on anything else, 30 minutes to two hours.

[00:49:32] Speaker 03:
The district court pointed to Beardman at 847, right?

[00:49:37] Speaker 06:
Excuse me?

[00:49:38] Speaker 03:
The district court pointed to Beardman at 847, right?

[00:49:45] Speaker 06:
I'm not sure that it did.

[00:49:46] Speaker 06:
I don't think it did.

[00:49:48] Speaker 02:
In the unexpected results discussion?

[00:49:51] Speaker 06:
District court?

[00:49:52] Speaker 06:
I don't think so, Your Honor.

[00:49:56] Speaker 06:
To my memory, there's no finding in the court's opinion, except in what you cited, too, in the... Oh, I'm sorry.

[00:50:06] Speaker 03:
It's that Dr. McGough conceded that the second-generation products have onset action in as early as 30 minutes.

[00:50:16] Speaker 03:
That's what the district court will do at page 47.

[00:50:18] Speaker 06:
Yeah, but second generation products, Your Honor, include products that have long effect and products that don't have long effect.

[00:50:24] Speaker 06:
There are second generation products that only have six to eight hour effect.

[00:50:28] Speaker 03:
So then would with the logical extension of Dr. Magot's testimony be that a subset of those second generation products had long duration effect and early onset of 30 minutes, while another subset would have a less than long duration but still have 30 minute onset?

[00:50:45] Speaker 06:
Yeah, I think, again, there are second generation products like Medidate CD who have an early TMAX that don't have more than six or eight hours effect.

[00:50:59] Speaker 06:
There are other products that have a late TMAX, like Focalin and Concerta, who don't have the early onset and have 12 hour efficacy.

[00:51:09] Speaker 06:
That's the exact evidence that the court relied on to show teaching away.

[00:51:14] Speaker 06:
on this very characteristics.

[00:51:17] Speaker 06:
So to cite to some general testimony that says, well, second generation products have a range of early onset, well, that in isolation means nothing unless you're looking at what these products actually disclose.

[00:51:32] Speaker 06:
And that's one of the areas.

[00:51:34] Speaker 02:
Before you sit down, has there been a launch?

[00:51:37] Speaker 06:
Excuse me?

[00:51:37] Speaker 02:
Has there been a launch?

[00:51:39] Speaker 06:
A generic launch?

[00:51:40] Speaker 06:
Mm-hmm.

[00:51:41] Speaker 06:
No, there has not.

[00:51:41] Speaker 02:
Well, there was FDA approval, right?

[00:51:45] Speaker 06:
I'm not sure.

[00:51:46] Speaker 06:
I don't think they do have final approval yet.

[00:51:51] Speaker 00:
Any more questions?

[00:51:55] Speaker 00:
Okay.

[00:51:56] Speaker 00:
We will take the case under submission.

[00:51:59] Speaker 00:
Thank you both.

[00:52:00] Speaker 06:
Thank you.