[00:00:00] Speaker 05:
at hand.

[00:00:01] Speaker 05:
Our first case is 21-1495 Tris Pharma versus Activist Laboratory.

[00:00:21] Speaker 00:
Good morning, Your Honor.

[00:00:22] Speaker 00:
Brian Burgess for Activist.

[00:00:23] Speaker 00:
This appeal concerns patents on a formulation for methylphenidate for MPH, which has been used to treat ADHD since the 1950s.

[00:00:30] Speaker 00:
Trist housed its product, Quilvin, as the first extended-release liquid formulation of MPH, but Trist did not appeal the trial court's findings that its liquid formulation claims are obvious over Trist's own prior art

[00:00:41] Speaker 00:
patent application meta, which discloses the drug delivery platform that Tris uses to make gold.

[00:00:47] Speaker 00:
What remains then are claims that combine certain clinical properties that had already been achieved in the prior art with certain pharmacokinetic details that happen to result from Tris' use of the meta platform.

[00:01:00] Speaker 00:
On remand from this court, the newly assigned district court judge held that these remaining claims were not obvious.

[00:01:07] Speaker 00:
But the court's conclusion rested on several legal errors, including two of particular importance.

[00:01:12] Speaker 00:
First, the court exceeded the scope of its mandate by reversing, on a cold record, findings that had been made by the trial judge and that were upheld by this court on appeal.

[00:01:22] Speaker 00:
Second, the court conflated obviousness with anticipation by repeatedly discounting references on the ground that they didn't perfectly overlap with the assertive claim limitations, rather than considering the prior art as a whole.

[00:01:35] Speaker 03:
Just starting with your first point, as I recall what this court did the last time around this case was on appeal, this court's opinion comprehensively

[00:01:49] Speaker 03:
stripped that district court opinion down to basically nothing, and to send the case back for a do-over, and ended up vacating that district court opinion completely.

[00:02:03] Speaker 03:
So for purposes of a productive oral argument this morning, I think it would be helpful if you just understood

[00:02:13] Speaker 03:
our court's opinion in that manner and considered this case as the district court on remand doing a do-over on the 103 question.

[00:02:26] Speaker 00:
I'm happy to do that.

[00:02:27] Speaker 00:
Judge Chan, if I could please have just a chance to push back on that premise first and then I'm happy to move on.

[00:02:33] Speaker 00:
We agree that the court

[00:02:35] Speaker 00:
recognized that Judge Sleat had missed several issues and remanded for supplemental findings, including on the ultimate questions of whether these claims were obvious.

[00:02:45] Speaker 00:
And we're not disputing any of that.

[00:02:47] Speaker 00:
We do think that within the opinion, and for example, at page 657 in the appendix at the end of the opinion, the court notes that it considered all the party's remaining arguments and found that they were unpersuasive.

[00:02:59] Speaker 00:
The court also specifically addressed this Kaczynski reference.

[00:03:02] Speaker 00:
And that was not an issue in which the court found that Judge Sleat had been ambiguous in his findings or hadn't made a clear finding.

[00:03:10] Speaker 00:
The court said it was important that he had found.

[00:03:12] Speaker 01:
So you think that kind of general tagline that we throw in at a lot of our opinions limited the scope of the remand, even though it didn't specifically affirm parts of the prior decision?

[00:03:23] Speaker 00:
I do.

[00:03:24] Speaker 00:
I think the other side doesn't have any account for what that means.

[00:03:27] Speaker 00:
The court could have done a straight vacature, but it didn't.

[00:03:30] Speaker 00:
It addressed some of the arguments.

[00:03:31] Speaker 00:
It found some unpersuasive.

[00:03:33] Speaker 01:
For example, I mean, isn't it just we've looked at these other arguments, and we don't find any of them sufficient to alter the judgment we're giving you, which is go do a do-over on the obviousness question.

[00:03:45] Speaker 00:
I don't think that's right.

[00:03:46] Speaker 00:
I mean, for example, the court specifically addressed Tris's lead argument about cycle benzoprene and whether that dictated an obviousness conclusion.

[00:03:53] Speaker 00:
And in footnote three of the opinion, the court said no.

[00:03:56] Speaker 00:
We find it distinguishable.

[00:03:56] Speaker 00:
So it couldn't have been that Judge Conley and Remann could have said, well, actually, cycle benzoprene dictates the obviousness.

[00:04:02] Speaker 01:
But how are we to determine from reading the opinion?

[00:04:04] Speaker 01:
And I obviously wasn't on the prior panel.

[00:04:06] Speaker 01:
what that general tagline is meant to, at least in your view, limit the scope of the remand.

[00:04:13] Speaker 01:
Do I have to go back and look at the briefs and parse them and determine, well, they raised this argument and that line rejected it, you know, group by group?

[00:04:21] Speaker 01:
If we wanted a limited remand, we say remand for X purpose.

[00:04:27] Speaker 01:
I mean, frankly, I shouldn't ask you these questions, because I think you're wasting your time.

[00:04:31] Speaker 01:
I'd suggest you get on to the rest of your argument, too, as my colleague did.

[00:04:36] Speaker 00:
Sure.

[00:04:36] Speaker 00:
Understood.

[00:04:36] Speaker 00:
So I'll turn to that.

[00:04:37] Speaker 00:
I think in terms of what we think was preserved is the importance of Skazinski.

[00:04:41] Speaker 00:
And I'm just happy to take that on just as an initial matter, whether the district judge was free to disregard and discount Skazinski on the ground that it was prophetic.

[00:04:51] Speaker 00:
A prophetic reference can still teach motivation, can still teach reasonable likelihood.

[00:04:56] Speaker 00:
As a prior art patent application, Skazinski is presumed enabled.

[00:05:02] Speaker 00:
There was testimony that was found credible but also unrebutted from our expert, Dr. Strong, that a skilled artisan would be able to look at Skazinski and translate its profile into a commercial product.

[00:05:16] Speaker 00:
The other side didn't present a pharmacokinetic expert.

[00:05:19] Speaker 00:
So that testimony, which is at pages 382 and 383 of the appendix, stood unrebutted and we think it's critical.

[00:05:26] Speaker 00:
So whether you get to Skazinski can't be discounted because on the basis of being prophetic based on the scope of this court's mandate or if you just get it as an initial matter that there is no basis for simply discounting a reference as prophetic when there is unrebutted expert testimony that a skilled artisan would credit it.

[00:05:43] Speaker 00:
It doesn't matter which path you get there.

[00:05:45] Speaker 00:
We do think Skaczynski is a critical reference, because based on the findings of Judge Connolly, the remand findings, Skaczynski almost perfectly overlaps with the relevant assertive claims.

[00:05:55] Speaker 03:
So where in your briefing below did you make the case that, OK, here's the Skaczynski reference.

[00:06:06] Speaker 03:
It teaches, well, you were strongly pushing the idea that it teaches everything in a claim.

[00:06:12] Speaker 03:
And so obviously, the district court pushed back on that and said, no, it does not.

[00:06:17] Speaker 03:
But for 103 purposes, where did you argue?

[00:06:21] Speaker 03:
Here's Skazinski.

[00:06:22] Speaker 03:
It's my primary reference.

[00:06:24] Speaker 03:
There's some little gaps here and there, but here's the motivation to make those minor modifications.

[00:06:34] Speaker 03:
And here is why there'd be a reasonable expectation of success, that when you make those modifications, you will still preserve the single peak profile.

[00:06:46] Speaker 00:
So the places where I think we make that argument most specifically are at 733 through 735 of the appendix.

[00:06:54] Speaker 00:
And you're right, Judge Chan.

[00:06:55] Speaker 00:
Our primary submission on remand was that we thought specific.

[00:06:57] Speaker 02:
So where in 733 to 735?

[00:07:04] Speaker 05:
Which volume of the appendix is this?

[00:07:06] Speaker 05:
I'm just out of curiosity.

[00:07:08] Speaker 05:
Why do we have eight volumes of appendix, each of which appear to be three pages long?

[00:07:13] Speaker 00:
Sure.

[00:07:13] Speaker 00:
The way it proceeded is that because we had a record from the first appeal, the parties designated the same record that had been used before, initially in the briefing, and then added on the additional materials that were supplemented on remand.

[00:07:28] Speaker 00:
I apologize for the court if it resulted in an unwieldy appendix.

[00:07:31] Speaker 00:
It did.

[00:07:31] Speaker 00:
Don't do it again.

[00:07:33] Speaker 00:
I apologize.

[00:07:34] Speaker 05:
Okay, so what volume do you want me to look at?

[00:07:38] Speaker 00:
Let's see, I don't have the volume number off.

[00:07:40] Speaker 03:
It's volume seven.

[00:07:41] Speaker 00:
Volume seven, I'm told.

[00:07:55] Speaker 05:
And what pagewood did you want?

[00:07:57] Speaker 05:
Six something?

[00:07:59] Speaker 00:
No, I believe it was that.

[00:08:05] Speaker 00:
733 is an example where it picks up.

[00:08:10] Speaker 00:
And if you can see, there's the little C where this argument is initially made.

[00:08:15] Speaker 00:
And as Judge Ten noted, it was our primary submission on remand that Skazinski overlapped entirely with the claim limitations because we were arguing that it took 45 minutes on set.

[00:08:22] Speaker 03:
Right, and that was objected, so now we're moving on to room three.

[00:08:25] Speaker 00:
Right.

[00:08:27] Speaker 00:
We then said, OK, the judge agreed with us as to many aspects of Skaczynski that had taught 12 hours, that had taught single peak, that had taught a T-max within the claimed range, but that he found that it taught within 60 minutes onset rather than 45.

[00:08:41] Speaker 00:
Here we argue, even if Skaczynski and Concerta, which we also argued, overlapped, and the judge disclosed all the limitations, the remaining 15-minute gap is not significant because you have the teaching from Metta in the prior art.

[00:08:54] Speaker 03:
But why would one be motivated in the first place to alter the one-hour early onset to a 45-minute early onset?

[00:09:05] Speaker 03:
I understand you're saying it's only 15 minutes.

[00:09:07] Speaker 03:
Another way to say it is it's a 25% reduction.

[00:09:11] Speaker 03:
And in the larger sense, there still has to be a reason for why someone would do that.

[00:09:16] Speaker 03:
And at the same time, why would there be

[00:09:20] Speaker 03:
a motivation to maintain and preserve the single peak profile.

[00:09:24] Speaker 03:
As I understand it, both experts testified that it doesn't matter.

[00:09:29] Speaker 03:
The single peak does not matter.

[00:09:31] Speaker 03:
They don't care.

[00:09:31] Speaker 03:
If the single peak ultimately turned into a bimodal profile, that would be fine by them.

[00:09:37] Speaker 03:
So that's the question that I have when I look at your Kaczynski argument, which

[00:09:43] Speaker 03:
Number one, where did you argue that here is the reason why people of skill in the art would want to get to a 45-minute early onset?

[00:09:52] Speaker 03:
In addition, here is why we are quite confident that the POSA would also want to still have a single peak profile in that circumstance, and it would be reasonable to get and preserve a single peak profile.

[00:10:06] Speaker 00:
Sure.

[00:10:06] Speaker 00:
So I understand that to be a two-part question, I think, in terms of

[00:10:09] Speaker 00:
First, why you would get to 45, and then why you'd also make a single P. And then where was that argued here?

[00:10:14] Speaker 00:
Sure.

[00:10:15] Speaker 00:
I mean, as to where to 45, that's stipulated.

[00:10:18] Speaker 00:
In page 570 of the original trial court opinion, it runs through the party stipulations.

[00:10:24] Speaker 00:
And it is stipulated that there would be a motivation to develop a product that has 45 minutes, liquid, 12 hours.

[00:10:31] Speaker 00:
So that part was stipulated that there would be a motivation

[00:10:35] Speaker 00:
achieve that.

[00:10:36] Speaker 00:
So the remaining question is whether there would be also a motivation to achieve these characteristics using a single peak.

[00:10:43] Speaker 00:
And we agree with your honor that the testimony from both sides experts from Tris's inventor was that artisans are essentially different to this question because it doesn't have therapeutic effect.

[00:10:53] Speaker 00:
The argument we're making there I think is primarily legal.

[00:10:56] Speaker 00:
that when you have indifference between two known, suitable results that have been used in the prior art, the choice between them is not something that determines novelty.

[00:11:09] Speaker 03:
That is true in the broadest sense, but that principle rests on a premise that both of those alternatives are in fact attainable, that are realistic.

[00:11:22] Speaker 03:
And here, it's not so clear that you can get a single peak profile in which way you mix all the ingredients.

[00:11:32] Speaker 03:
In fact, it seems pretty rare that you ever get a single peak profile based on the different examples that were actually produced in the prior art.

[00:11:41] Speaker 03:
So that's the concern, is you've got an uphill climb to make on explaining why it would be

[00:11:49] Speaker 03:
there'd be confidence that, one, you keep stretching the early onset time further and further away from the 12-hour duration length, that you would still be able to maintain and preserve a single peak profile in that circumstance.

[00:12:03] Speaker 03:
And that's what I'm looking for here.

[00:12:05] Speaker 00:
Sure.

[00:12:05] Speaker 00:
I mean, on stretching away from the 12, the relevant claim limitation is about 12 hours, which actually goes down to 10.8.

[00:12:13] Speaker 00:
And Skazinski discloses a range that goes from 11 to 12.

[00:12:17] Speaker 00:
And so going from 60 to 45, when you combine it with the meta reference, which discloses that it was a matter of routine optimization to change the mixture of immediate release and sustained release components to get the profile you want.

[00:12:29] Speaker 03:
I believe the district court found that meta was a little bit too

[00:12:33] Speaker 03:
generic in its description of, yes, there's lots of tools in the toolkit to mix things in different ways, but it doesn't comment in any way that here's how you make sure you're always going to have a single-pick profile.

[00:12:48] Speaker 03:
And I guess that was the concern.

[00:12:50] Speaker 03:
How do you maintain that?

[00:12:51] Speaker 03:
And the evidence wasn't, in the district court's view, clean and clear enough on that score.

[00:12:56] Speaker 00:
Sure.

[00:12:57] Speaker 00:
I understand that from meta.

[00:12:59] Speaker 00:
Dr. Moriton at trial testified that a skilled artisan

[00:13:02] Speaker 00:
With background knowledge in the art, reading meta would believe that you could use domestic meta to customize it while maintaining a single peak profile.

[00:13:10] Speaker 00:
And Judge Sleep did find that testimony credible.

[00:13:13] Speaker 00:
Judge Connolly purported not to disturb his credibility.

[00:13:17] Speaker 00:
but it seems like he nonetheless found the opposite as to that issue.

[00:13:23] Speaker 00:
So I think the important point is that we're not relying only on Metta or only on Skaczynski.

[00:13:31] Speaker 00:
And we think it was a basic error Judge Conley made when he looked at those references only in isolation rather than considering what they teach together.

[00:13:40] Speaker 00:
And as to your, you suggested that there had not been many examples in the prior art of the single peak.

[00:13:46] Speaker 00:
And there were some, De Trana is, is an example.

[00:13:49] Speaker 00:
But to the, and there's only one example in the prior art, Copeland XR, that achieved these.

[00:13:55] Speaker 00:
the clinical properties and the fact that there's one example that is bimodal we don't think under this court's case law is sufficient for a teaching away.

[00:14:05] Speaker 00:
Now what the other side really relied on at trial for arguing that there was a teaching away that you would think a single peak wouldn't work

[00:14:12] Speaker 00:
is the acute tolerance theory that Dr. McGough testified at length.

[00:14:16] Speaker 00:
But Judge Connolly specifically declined to rely on acute tolerance.

[00:14:21] Speaker 00:
He wouldn't make a finding on that.

[00:14:23] Speaker 00:
So absent the finding on that, you have examples in the prior art that are single peak.

[00:14:28] Speaker 00:
You have Skaczynski indisputably using a single peak profile to achieve these clinical properties.

[00:14:35] Speaker 00:
You have testimony that a skilled artisan would have been inclined to look to Skaczynski because it's seeking to achieve the same basic properties as the Pattinson suit.

[00:14:47] Speaker 00:
It's trying to achieve effective once daily.

[00:14:50] Speaker 00:
medication that has rapid onset and extended duration.

[00:14:54] Speaker 00:
We have undisputed expert testimony from our pharmacokineticists that you would be able to use a well-established technique to translate Schisinski's profile to a commercial product.

[00:15:05] Speaker 00:
So given all that, we think that there is ample basis for motivation and reasonable expectation.

[00:15:11] Speaker 00:
And in the absence of anything to support a finding of teaching away, which Judge Connolly conspicuously declined,

[00:15:19] Speaker 00:
He said, having not witnessed the expert testimony, I lack the confidence to make a finding on that.

[00:15:26] Speaker 00:
But nonetheless, he then relied on the same expert testimony when suggesting that there was a teaching away.

[00:15:31] Speaker 00:
That is internally contradictory and we think cannot be sustained.

[00:15:37] Speaker 05:
Council, you've used all of your time, so let's hear from Mr. Taylor, please.

[00:15:57] Speaker 04:
Good morning.

[00:15:58] Speaker 04:
Harold Taylor for Tris.

[00:16:01] Speaker 04:
I want to dive, I guess, right into the prior art and Skazinski.

[00:16:10] Speaker 04:
That reference, the Skazinski reference, is something that activists relies heavily on, as we discussed in his argument.

[00:16:22] Speaker 04:
But what is clear about Skazinski is that it omits.

[00:16:27] Speaker 04:
certain important claim limitations that activists seems to gloss over.

[00:16:36] Speaker 04:
Skaczynski does not disclose a liquid product.

[00:16:42] Speaker 04:
Product that is at issue in this case is the first liquid formulation of methylphenidate.

[00:16:48] Speaker 04:
It is the first and only liquid formulation that results in a 45-minute onset of activity and 12 hours worth of therapeutic effect that allows these children to have this product effective during the day.

[00:17:04] Speaker 04:
Simply just not OK to read out limitations in the claims.

[00:17:09] Speaker 03:
Well, do you disagree?

[00:17:11] Speaker 03:
there would have been a motivation to make Skaczynski into a liquid formulation because it was desirable to have a liquid formulation at the time?

[00:17:20] Speaker 04:
There's absolutely nothing in the record that suggests the motivation to start with Skaczynski and to make it into a liquid formulation.

[00:17:28] Speaker 04:
It's just not there.

[00:17:30] Speaker 03:
I thought part of your secondary consideration story is that people at the time were really

[00:17:38] Speaker 03:
interested in having a liquid version of this drug.

[00:17:43] Speaker 03:
Absolutely.

[00:17:44] Speaker 03:
So then there was a motivation.

[00:17:46] Speaker 03:
There was a desire.

[00:17:47] Speaker 03:
There was an interest to have this as a liquid formulation.

[00:17:50] Speaker 04:
Well, that's two different things.

[00:17:51] Speaker 04:
There was a motivation, clearly, and a long-felt need for a liquid, long-acting methylphenidate formulation that had a very early onset of activity and 12-hour efficacy.

[00:18:07] Speaker 04:
There is no evidence that a person of ordinary skill would have looked to Skizinski to satisfy and solve that problem.

[00:18:15] Speaker 04:
And that is where the key hole is in the activist evidence.

[00:18:21] Speaker 04:
Skizinski does not disclose illiquid product.

[00:18:25] Speaker 04:
Now, there has been some discussion about the fact that it's a prophetic reference.

[00:18:31] Speaker 04:
And what does that mean to a person of ordinary skill as they review that document?

[00:18:37] Speaker 04:
Now, clearly I agree that a publication should be reviewed and understood for what it discloses, but it also should be looked at for what it doesn't disclose.

[00:18:51] Speaker 01:
Now, this reference... Apart from the liquid formulation, what doesn't Skazinski disclose?

[00:18:58] Speaker 04:
It does not disclose 45 minutes onset of activity.

[00:19:02] Speaker 01:
It only has an hour, is that right?

[00:19:03] Speaker 04:
It has an hour.

[00:19:04] Speaker 04:
Now, again, this is where the fact that it's a prophetic paper patent is relevant.

[00:19:11] Speaker 04:
The authors of Skazinski could have put any time period in their disclosure.

[00:19:21] Speaker 04:
if they thought that what they were disclosing would have gotten to that time period.

[00:19:27] Speaker 04:
They chose to put in one hour.

[00:19:29] Speaker 05:
But what about closing councils pointing to page, I think it's 570 in the record, paragraph 97, where there's a fact finding that as of July 2010, a posa would have been motivated to make a liquid with an early onset, for example, 45 minutes.

[00:19:47] Speaker 05:
But is that correct?

[00:19:49] Speaker 05:
Not a fact finding?

[00:19:50] Speaker 04:
Sure, that's a fact finding.

[00:19:51] Speaker 04:
But that's like saying scientists today are motivated to find a cure for cancer.

[00:19:57] Speaker 04:
The motivation to find the answer to this longstanding problem is frankly one of the reasons why the court found that there were second every indicior of unobviousness.

[00:20:11] Speaker 04:
Methylphenidate had been known for almost 50 years at the time of the invention.

[00:20:16] Speaker 04:
There had been a long felt need

[00:20:19] Speaker 04:
for a liquid product that had very early onset of action and 12-hour efficacy.

[00:20:27] Speaker 04:
That's the motivation.

[00:20:28] Speaker 04:
But for 50 years, no one came up with an answer to that problem until the scientists at Truss did it.

[00:20:36] Speaker 04:
So you can't use the motivation.

[00:20:39] Speaker 01:
I know this isn't part of the case.

[00:20:41] Speaker 01:
But you've talked about all these different

[00:20:44] Speaker 01:
criteria of 45 minutes, 12 hours, one peak, and stuff like that.

[00:20:49] Speaker 01:
None of this case explains how any of this was done.

[00:20:52] Speaker 01:
I mean, it's not in the claims that are our issue here.

[00:20:55] Speaker 01:
But it seems to me that if there was a problem, it was the scientists couldn't come up with the specific proportions.

[00:21:02] Speaker 01:
But that's not what these claims are based upon.

[00:21:04] Speaker 01:
They just claim these criteria.

[00:21:07] Speaker 01:
And we don't even know how it's done from the claims we're looking at.

[00:21:11] Speaker 04:
Well, the patent clearly describes in its body how it's done.

[00:21:17] Speaker 04:
And there was testimony, extensive testimony, at trial.

[00:21:20] Speaker 01:
I know.

[00:21:20] Speaker 01:
Why aren't the claims directed to, here's the composition that will give you these results, rather than just the results themselves?

[00:21:28] Speaker 04:
The claims include both.

[00:21:30] Speaker 04:
We're focusing on the informative.

[00:21:32] Speaker 01:
Are the ones that actually claim the compositions the ones that are no longer valid?

[00:21:37] Speaker 01:
Excuse me?

[00:21:38] Speaker 01:
Are the ones that claim the composition the ones that are no longer valid under the other prior art?

[00:21:43] Speaker 04:
The claims that were limited to the composition were the ones that we chose not to focus on in the appeal and the district court found to be

[00:21:52] Speaker 04:
obvious.

[00:21:53] Speaker 01:
So you can't get the claims to the composition, but you can get the claims to the effect of the composition?

[00:21:59] Speaker 04:
Well, I wouldn't call it the effect of the composition.

[00:22:02] Speaker 04:
It is the combination of the pharmacokinetic properties and the pharmacodynamic clinical effects of the composition that led to this important therapy.

[00:22:14] Speaker 04:
Now, that's what those claims

[00:22:16] Speaker 04:
are directed to and that was not presaged or predicted by the prior art.

[00:22:22] Speaker 05:
I'm a little confused by your understanding of our motivation to combine law.

[00:22:30] Speaker 05:
Methylphenidate existed for a long period of time prior to this and there's a fact finding that you haven't appealed and possibly even stipulated to, I don't know, but a fact finding that APOSTA would have been motivated to make a liquid ER methylphenidate formulation with an onset of 45 minutes in 2010.

[00:22:53] Speaker 05:
So I guess what is it that you think the law of motivation to combine requires that isn't satisfied by that combination?

[00:23:05] Speaker 04:
That says nothing about combining one reference, Skaczynski.

[00:23:10] Speaker 05:
to solve that problem, when Skaczynski doesn't disclose the liquid, doesn't disclose early onset, and its disclosure is... Yes, but if there existed a motivation to turn methylphenidate into a liquid, wouldn't that motivation, which has been found as a matter of fact, exist with regard to every reference that discloses methylphenidate?

[00:23:36] Speaker 04:
Well, that's one way to look at it, but Skaczynski wasn't the only methylphenidate formulation.

[00:23:41] Speaker 04:
What the court found is that look at the actual drugs that were on the market that were methylphenidate long-acting formulation.

[00:23:50] Speaker 04:
None of them came close to solving the product this way.

[00:23:56] Speaker 04:
Focalin.

[00:23:57] Speaker 05:
The only product that goes to a reasonable expectation of success or possibly it goes to secondary considerations.

[00:24:07] Speaker 05:
But I don't see how that gets pigeonholed under motivation to combine.

[00:24:11] Speaker 05:
It seems to me there is a motivation to take any methylphenidate product or reference and make it liquid.

[00:24:18] Speaker 05:
It seems like there is a motivation to take any methylphenidate product or reference and have it have early onset action, because that's what these fact findings that aren't appealed say was present at the time.

[00:24:32] Speaker 05:
So I don't understand how you believe we should find there was no motivation to modify Szynski

[00:24:40] Speaker 05:
in order to make it liquid or in order to have it on set in 45 minutes.

[00:24:45] Speaker 04:
Well there was no evidence put on about that motivation.

[00:24:51] Speaker 04:
Now the court may assume

[00:24:54] Speaker 04:
You may decide to assume that the motivation... I'm not assuming anything.

[00:24:57] Speaker 05:
There's a fact finding.

[00:24:59] Speaker 05:
Was this stipulated to?

[00:25:01] Speaker 05:
I believe it was, Your Honor, but that... So there's a stipulation that in 2010, people of skill in the art were looking at methylphenidate and trying to reduce its onset to 45 minutes.

[00:25:17] Speaker 04:
And trying to develop a liquid formulation.

[00:25:21] Speaker 04:
And no one was successful in doing that.

[00:25:23] Speaker 03:
Just so I understand, if I can understand this colloquy, perhaps what you're trying to say is, generically, broadly speaking, there might have been an interest, a motive, a motivation to try to get an early onset, as early as 45 minutes, and have a liquid formulation of this drug.

[00:25:42] Speaker 03:
But activists did not present the case

[00:25:46] Speaker 03:
a Zizinski-centric case for why you would convert Zizinski into a liquid formulation, why you would take Zizinski and make a 45-minute and still be able to have all the other claim elements that are recited in the claim.

[00:26:03] Speaker 04:
And getting to your point, Judge Moore, is where is the evidence that there was a reasonable expectation of success in doing that?

[00:26:10] Speaker 05:
Well, but that I understand.

[00:26:12] Speaker 05:
That's where I think your argument fits.

[00:26:14] Speaker 05:
Where, for me, I'm struggling is to fit it within the rubric of motivation to combine, which I think is a different analysis than reasonable expectation of success.

[00:26:26] Speaker 04:
I would posit that it's both.

[00:26:28] Speaker 05:
Well, yes, I understand you'd like to win on all issues.

[00:26:31] Speaker 05:
Yes, I get that.

[00:26:33] Speaker 03:
Can you focus on reasonable expectation of success, then?

[00:26:36] Speaker 04:
Sure.

[00:26:37] Speaker 04:
One of the things that council alluded to was that the holes in the Skazinski references, assuming that someone even would even start to then include that it's a liquid and that it doesn't meet the 45-minute onset.

[00:26:53] Speaker 04:
And they said, look at meta.

[00:26:56] Speaker 04:
which is this general reference that only discloses what is clearly known in the art, that you could adjust the number of fast acting and delayed release components in a formulation.

[00:27:12] Speaker 04:
Metta says nothing about specifically changing the onset of activity in a product, in a liquid product, in a manner that would do two things.

[00:27:26] Speaker 04:
reduce the onset time for onset of activity and maintain the clinical profile, the PK profile, such that it maintains the single mean P.

[00:27:40] Speaker 04:
Metta says nothing about that.

[00:27:42] Speaker 04:
And the testimony on this Metta issue is by their expert, Morton.

[00:27:49] Speaker 04:
And I would ask the court to really look at that testimony.

[00:27:52] Speaker 04:
It's at 325 and 326 in the record, and also 970 and 971.

[00:27:59] Speaker 04:
That's the testimony that activists relies on.

[00:28:04] Speaker 04:
to fill the gap, the gaping hole in Skazinski.

[00:28:09] Speaker 01:
So if there is this long felt need for a liquid formula with these characteristics, how did you achieve it when everybody else was looking for it?

[00:28:17] Speaker 01:
Well, the sun... What specific, you know,

[00:28:20] Speaker 01:
characteristics did you find that nobody else could get to?

[00:28:23] Speaker 04:
Well, it was a bit of serendipity.

[00:28:26] Speaker 04:
The scientists at Trist were working on this product for quite so many years, trying to figure out how to develop a liquid product that met these characteristics.

[00:28:38] Speaker 04:
And they found this product.

[00:28:41] Speaker 04:
And they realized that to make an effective product, you had this particular profile.

[00:28:49] Speaker 04:
the single mean peak profile that people in the art.

[00:28:53] Speaker 01:
I'm asking you, I don't really want to talk about the profile, which is all you want to talk about.

[00:28:58] Speaker 01:
How did you come up with the composition that gets to that profile?

[00:29:02] Speaker 01:
How is that different from what everybody else was doing, the actual composition?

[00:29:08] Speaker 01:
The actual composition.

[00:29:10] Speaker 01:
The actual composition is what gets you the profile, right?

[00:29:14] Speaker 01:
But that's part of it.

[00:29:15] Speaker 01:
Well what else gets you the profile?

[00:29:18] Speaker 04:
How the composition, the components, the

[00:29:24] Speaker 04:
pellets that are involved in the methylphenidate, what the combination is of those to come to the specific PK profile.

[00:29:33] Speaker 04:
What do you mean when you say the combination of pellets?

[00:29:37] Speaker 04:
What are you talking about?

[00:29:38] Speaker 04:
The formulation includes a number of different pellets, methylphenidate resin pellets in the formulation.

[00:29:48] Speaker 04:
And these pellets have varying amounts of coatings on them.

[00:29:53] Speaker 04:
and how you mix those pellets.

[00:29:59] Speaker 04:
Are there different kinds of pellets?

[00:30:02] Speaker 01:
Are there different kinds of pellets?

[00:30:04] Speaker 01:
Excuse me?

[00:30:04] Speaker 01:
Are there different kinds of pellets?

[00:30:06] Speaker 04:
Yeah, there's at least two different kinds of pellets.

[00:30:08] Speaker 01:
Is it the slow acting and the fast acting?

[00:30:10] Speaker 04:
That's one way to characterize it.

[00:30:12] Speaker 04:
They're methylphenidate resins that are coated.

[00:30:21] Speaker 01:
I mean, I would have expected in a case like this where everything seems, I mean, this has been around forever, that what we were arguing about for expectation of success is the particular percentages you have, the particular coatings, make them release faster or lower, that that's what gave you the expectation of success.

[00:30:40] Speaker 01:
And I get it, our law lets you just claim

[00:30:42] Speaker 01:
like properties without actually also relying on the underlying characteristics.

[00:30:50] Speaker 01:
But it seems like if you had an expectation of success argument, it would be, well, nobody ever thought of mixing them this way and using this particular coding or this recipient or things like that.

[00:31:01] Speaker 01:
But there's none of that in this case, is there?

[00:31:04] Speaker 04:
Yeah.

[00:31:04] Speaker 04:
Well, it's our view that it's actually both, right?

[00:31:07] Speaker 04:
I mean, you wouldn't have this invention without both parts of it, the formulation side of it that enable the person to formulate methylphenidate in this manner, but also the pharmacokinetic and pharmacodynamic side that announce a lot.

[00:31:23] Speaker 03:
Your time is up, but I just wanted to ask this one last question.

[00:31:26] Speaker 03:
I understand why it's desirable to get early onset.

[00:31:30] Speaker 03:
I understand why it's desirable to have an all-day duration effect.

[00:31:35] Speaker 03:
I understand why it's desirable to have a liquid formulation.

[00:31:39] Speaker 03:
What's the purpose of a single peak?

[00:31:41] Speaker 03:
All the experts say it doesn't matter.

[00:31:44] Speaker 03:
Single peak, bimodal, it doesn't matter.

[00:31:47] Speaker 03:
Why is that limitation in the claim?

[00:31:49] Speaker 03:
What is the purpose of that limitation in the claim?

[00:31:53] Speaker 04:
Well, it actually does matter.

[00:31:55] Speaker 04:
Because why?

[00:31:56] Speaker 04:
Because with these products, with this product,

[00:32:00] Speaker 04:
to ensure that you get the pharmacodynamics, the clinical effect.

[00:32:07] Speaker 04:
The researchers assume that this PK curve is important.

[00:32:15] Speaker 04:
And that's acknowledged by the FDA.

[00:32:17] Speaker 04:
The FDA, it's in our record, the FDA included a more stringent pharmacokinetic requirement for generics to get an equivalent product to Quilivar, the product of the invention, so that it matched this PK curve.

[00:32:37] Speaker 04:
That's one of the things that's so unobvious about this invention, that with regard to this product, excuse me?

[00:32:45] Speaker 04:
A record site.

[00:32:46] Speaker 04:
I do.

[00:33:07] Speaker 04:
It's 261.

[00:33:13] Speaker 04:
What volume is that?

[00:33:17] Speaker 04:
Which is the testimony of... What volume is it?

[00:33:21] Speaker 04:
I'm not sure what volume it is.

[00:33:24] Speaker 04:
And also the FDA guidance on this specific issue is at 1466 and 1667.

[00:33:37] Speaker 04:
260 to 61 is the testimony of Trish's Mr. Caton.

[00:33:48] Speaker 05:
Are you good, Judge?

[00:33:48] Speaker 04:
I'm done.

[00:33:49] Speaker 05:
All righty thank you Mr. Taylor.

[00:33:52] Speaker 05:
Thank you.

[00:33:53] Speaker 05:
Mr. Burgess, only because we went over with Mr. Taylor, I'll restore two minutes and 48 seconds of rebuttal time.

[00:34:01] Speaker 05:
But since you used it all, you may have been without any had that not happened.

[00:34:05] Speaker 05:
So just be wary in the future.

[00:34:06] Speaker 00:
Sure, thank you Your Honor.

[00:34:08] Speaker 00:
So starting with the question of whether there'd be a motivation to translate Skaczynski to a liquid and whether there was testimony about that.

[00:34:14] Speaker 00:
There absolutely was.

[00:34:15] Speaker 00:
That was Dr. Stoller's testimony in Appendix 283-284, which is what Judge Slee credited.

[00:34:23] Speaker 00:
Council also suggested that there was no evidence that META would provide a basis for achieving quicker onset.

[00:34:30] Speaker 00:
That's also wrong.

[00:34:32] Speaker 00:
Page 966 of the appendix, that's Dr. Morton's testimony explaining how META could be customized by changing the ratio of immediate release to sustained release.

[00:34:41] Speaker 05:
Yes, but these are fact questions.

[00:34:42] Speaker 05:
The fact that there exists in the record some evidence that you can point to the contrary doesn't get you over the fact.

[00:34:48] Speaker 00:
I agree with that, but on that issue, Judge Connolly didn't make a contrary finding about

[00:34:53] Speaker 00:
Our point there is he did not consider Metta and Skaczynski together.

[00:34:58] Speaker 00:
He said, Skaczynski, well, it doesn't disclose 45 minutes.

[00:35:01] Speaker 00:
Therefore, there's not a motivation and there's not a reasonable expectation of success.

[00:35:05] Speaker 00:
And Metta alone doesn't show you could achieve all these characteristics.

[00:35:09] Speaker 00:
We're not arguing otherwise.

[00:35:10] Speaker 00:
We're saying when you combine these references, which is what Judge Connolly did not do.

[00:35:16] Speaker 00:
To Judge Hughes' question about, you know, how was it that Tris was able to achieve this?

[00:35:22] Speaker 00:
Isn't this a product of the combination of the release components?

[00:35:27] Speaker 00:
The answer to that is yes, and we think to the extent that there was an advance that Tris accomplished, it was meta.

[00:35:32] Speaker 00:
It was the prior patent application, which then issued as a patent, which it claims in the Orange Book,

[00:35:38] Speaker 00:
But they didn't assert that patent against us because we don't infringe it.

[00:35:42] Speaker 00:
There's a different polymer coding that we use versus that was claimed in the patent, so they couldn't assert that against us.

[00:35:49] Speaker 00:
But to the extent there was an advance about how to develop a liquid formulation,

[00:35:53] Speaker 00:
about how to figure out the proper ratios to achieve these characteristics.

[00:35:57] Speaker 00:
That comes from that patent, that patent application that's issued as a patent that they don't assert against us.

[00:36:03] Speaker 00:
The claims that are being asserted here are just efforts to optimize meta and to make obvious modifications to achieve these particular characteristics that had been achieved in the art and that there's stipulation that a skilled artist would be motivated to achieve.

[00:36:18] Speaker 00:
If the court has no further questions, we urge you to regret.

[00:36:22] Speaker 05:
Thank you.

[00:36:23] Speaker 05:
I think that actually this case is taken under submission.