[00:00:00] Speaker 03:
Final case for argument this morning is 23-1953 for Duke-Harmont v. Accord Health Care.

[00:00:08] Speaker 03:
We would begin at the end of a long morning.

[00:00:11] Speaker 03:
It's no longer existent anymore.

[00:00:14] Speaker 01:
Thank you, Your Honors.

[00:00:16] Speaker 01:
May it please the Court.

[00:00:17] Speaker 01:
The District Court invalidated for obviousness two sets of patents claiming innovative solutions to problems with the original formulation of OxyContin.

[00:00:28] Speaker 01:
I'd like to focus today with three primary flaws with that decision.

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First, the district court glossed over admitted gaps in the prior art by invoking the obvious-to-try principle, even though it failed to find the basis for invoking that principle, a finite set of predictable solutions.

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And even though a court's own expert testified that heating PEO above its melting point without compression

[00:00:57] Speaker 01:
could result in a puddle, the very opposite of what an innovative solution would have called for.

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Second, even putting aside that error, there are overwhelming indications of non-obviousness in this case.

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Oxycontin was a billion dollar drug that faced an existential threat stemming from abuse.

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Everyone knew this, and everyone tried to develop an abuse resistant patent.

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abuse-resistant tablet for extended release oxycodone.

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There was no legal bar, no existing monopoly, as the district court seemed to believe, to the development of an abuse deterrent patent.

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If anyone else had done that, I don't think we would be here today talking about whether or not that was obvious.

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But Purdue succeeded after many others failed.

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And I think that that story, those facts, make it impossible to find that this was all obvious to begin with.

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With respect to the low ABAC patents, Purdue did exactly what this court and the district court in the prior Epic case said it could do to avoid a finding of obviousness.

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It tailored its claims to the removal of 8 alpha rather than the end product, an oxycodone with low 14 hydroxy levels.

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In other words, Purdue claimed the discovery of 8 alpha itself

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something that the district court in this case found was a surprisingly important component to the solution.

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In those circumstances, the low ABAC patents could not be obvious either.

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For those reasons, the district court should reverse.

[00:02:39] Speaker 01:
I'd like to go back and begin with the abuse deterrent patents and the problem with the invocation of the obvious to try principle.

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Now, this was a narrow principle that the Supreme Court and this court has acknowledged to overcome gaps in the prior art

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But it's narrow because it has to be.

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If you engage in hindsight, it can always be clear with hindsight that it's obvious to try something.

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But this court and the Supreme Court have repeatedly said, you have to find a situation where there's a finite set of easily traversable options.

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Let me just ask you this.

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One of the ways that the obviousness to try path is sometimes invoked is as a kind of substitute for proving in the ordinary way a motivation to go down a particular path.

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And that's what makes it maybe a little bit fraught with danger.

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So you have to have only a few possibilities, and you have to kind of know what the result is going to be.

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And then you say, all right, they're all obvious.

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But we don't really have a situation where

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there's lacking a independently proved motivation to go down this path.

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Even in your description, if you want to try to solve this Oxycontin abuse problem, you can, you know,

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make it smell or taste bad.

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You can add something to get rid of the high that motivates people to want to abuse it.

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Or you can make it less liquefiable and therefore injectable, or less sniffable, or something like that.

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All of which are obvious possibilities.

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And we certainly have lots of case law over decades that say,

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You don't assume that the skilled artisan has to pick just one of them, as long as this is one of the things the skilled artisan would do, step down the path of making it harder or whatever it is.

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And then the rest of the story flows here without having to do this obviousness to try.

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Just to you to address that little story as well.

[00:04:57] Speaker 01:
Sure, Your Honor.

[00:04:58] Speaker 01:
I mean, first, I think it's clear that Judge Andrews invoked obvious to try here.

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If it was error for him to even invoke it, then he should go back and perform the correct analysis.

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But second, I think what Judge Andrews did is he admitted that there were gaps in the prior art as to both the curing limitation and the time and temperature limitation.

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And he had to overcome those gaps.

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And so he invoked the principle of obvious to try to say that, well, you had ovens, and it would be obvious to try ovens.

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But he did so without finding that there were a finite set of predictable

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solutions here.

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And just to take the predictability part of it, which is really important, this was unpredictable at all.

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No one had ever used an oven to heat PEO before in the prior art.

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No one had ever used an oven to heat any polymer in the prior art above its melting point.

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And Purdue's own expert at page 520, 5265 of the appendix here acknowledged that heating PEO above its melting point could cause it to puddle.

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So there's no reason to think it was predictable to heat PEO above its melting point without compression.

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In fact, as its expert acknowledged, the belief was that that would result in a puddle.

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So to invoke the obvious-to-try principle in that case, to overcome those gaps in the art, is really to just drive a hole through the obviousness analysis.

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And as you rightly indicated, Your Honor,

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The reason why there are constraints on that principle is to avoid the trap of hindsight.

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Same with the objective indications that maybe we can talk about a little bit later.

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And here, the district court's analysis is written with hindsight throughout, as was a court's case.

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I mean, at trial, the expert was asked, well, there are various ways you could do it.

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And she said, well, one way you could do it is this way.

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Well, you can always say that in hindsight.

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And this is really important, because again, if you just take a step back and look at the big picture here,

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Oxycontin was a billion-dollar drug.

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It faced an existential threat to the point that the FDA was threatening to withdraw it from the market and eventually did withdraw it from the market.

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Many people around the world tried to develop a solution for this, recognizing that if they did so, there was a jackpot at the end of the rainbow.

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And people tried to fill.

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Who involved?

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When you say many, tell me if I'm wrong.

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I think I'm remembering that

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your evidence on this, at least in the district court opinion, is about two triers.

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So there was Accord, there was Grunenthal, there was the O'Connor product.

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There's certainly... Is O'Connor a Grunenthal product?

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O'Connor was... I think it was an Endo product, Your Honor.

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Oh, okay.

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So there were others that were trying and failing.

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Purdue itself

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spent hundreds and millions of dollars and nearly a decade on this effort.

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Grunenthal had the benefit of the Bartolomus reference.

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And the testimony was that he had 400 different formulations, 900 batches, and he couldn't do it.

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And of course, the way that Bartolomus did it was he went to the trouble of building this contraption in which he put a tablet press inside of a heating cabinet and did it that way.

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But the invention, the ingenuity here, was that you could heat PEO above its melting point without compression and achieve this abuse-resistant tablet that no one did before.

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And with respect, I don't think we would be here today if another company had done that and established the abuse-resistant tablet, gone on the market with it, and taken over the market, particularly after FDA withdrew the approval for the original oxycodone because of the problems with abuse.

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That would be clear.

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And I think what this boils down to on the secondary indicia is really commercial success.

[00:09:02] Speaker 01:
Purdue's expert acknowledged, in her words, that there was definitely a long-felt but unmet need for this product.

[00:09:11] Speaker 01:
Accord's experts acknowledged that sales would have been lower without the abuse deterrent properties.

[00:09:21] Speaker 00:
The district court attributed commercial success, maybe just in passing, but with the statement that Purdue had a monopoly in this area.

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And for that reason, apparently, you cannot argue commercial success.

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Can you respond to that?

[00:09:40] Speaker 01:
Yes, Your Honor.

[00:09:41] Speaker 01:
And that was absolutely incorrect.

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And I don't even think my friends really defend that.

[00:09:46] Speaker 01:
They try to say monopoly meant something else.

[00:09:49] Speaker 03:
Existing monopoly is used to refer to... Can it mean it had market control here or it had a substantial stake in the market here historically?

[00:10:02] Speaker 01:
That's certainly not the way we... I think monopoly is a legal word.

[00:10:05] Speaker 01:
If a judge is using that one would tend to think that it has absolute control.

[00:10:09] Speaker 01:
Here there were other players that eventually entered the market for the extended release and I don't think that that

[00:10:16] Speaker 01:
that even if you looked at that way, Judge Prost, that would solve the commercial success issue because this was an existential threat to OxyContin.

[00:10:26] Speaker 01:
FDA threatened to remove it from the market and did remove it from the market.

[00:10:31] Speaker 01:
Oxycodone was off patent.

[00:10:33] Speaker 03:
Anyone could have developed a... You had an expert on this, right?

[00:10:37] Speaker 03:
Excuse me?

[00:10:38] Speaker 03:
You brought in an expert on commercial success.

[00:10:40] Speaker 03:
As I recall, the record

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He noted that all sales of the original formulation were transferred to the new formulation.

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And also, he didn't specifically consider the claimed features in assessing commercial success.

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Don't you need that to establish commercial success?

[00:10:59] Speaker 01:
So I don't think you would hear, Your Honor, because if we hadn't developed, without the abuse deterrent patent,

[00:11:07] Speaker 01:
we couldn't have gone forward with the original formulation of OxyContin.

[00:11:10] Speaker 01:
All the sales would have been lost.

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And I'd be happy to go through the evidence on this.

[00:11:14] Speaker 01:
First, a court's own expert acknowledged that sales would have been lower without the abuse deterrent tablet.

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That's at 5993 of the appendix.

[00:11:24] Speaker 01:
Second, a survey of prescribers showed that abuse deterrent was, quote, one of the highest unmet needs in the market.

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That's at 5374.

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The survey also showed that abuse deterrents

[00:11:36] Speaker 01:
was one of the most important data that they reviewed.

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That's at 5376.

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Producing marketing materials were focused on the scientific data about abuse deterrents at 539697.

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And there was evidence that there were other players in the market.

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This was all the kind of evidence that this court has looked to in the past.

[00:11:54] Speaker 01:
It looked to in the Apple case.

[00:11:55] Speaker 01:
In the Apple case, the court found that the slide lock feature

[00:11:59] Speaker 01:
was important to commercial success, and this overcame a claim of obviousness.

[00:12:04] Speaker 01:
And I know that everybody didn't agree with that, but this case is worlds removed from a slide lock feature.

[00:12:09] Speaker 01:
This is about the ability to bring an extended release oxycodone to market in the face of a grave public threat crisis that was an existential threat to this drug.

[00:12:21] Speaker 04:
Okay, can you remind me, once Purdue had this,

[00:12:26] Speaker 04:
This may be so obvious, but it went to the FDA and got approval to market it?

[00:12:31] Speaker 04:
Yes.

[00:12:32] Speaker 01:
Initially, the FDA expressed skepticism about it.

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It studied it further and eventually got the label for abuse deterrent.

[00:12:39] Speaker 04:
And then the initial approval was on a regular old new drug application or some modification of the earlier?

[00:12:47] Speaker 01:
It was on the, I believe it was on the original application, just studied it further and eventually granted the approval for the abuse deterrent.

[00:12:55] Speaker 04:
Um, formulation is that, was that a, um, I don't know, a process that was streamlined in a way that was unique to Purdue having the original.

[00:13:09] Speaker 01:
I don't believe so.

[00:13:10] Speaker 04:
So anybody else could have.

[00:13:13] Speaker 04:
gotten onto the market as fast as with the abuse deterrent product as Purdue?

[00:13:20] Speaker 01:
I believe so, Your Honor.

[00:13:21] Speaker 01:
And FDA studied it for three years before approving it.

[00:13:25] Speaker 04:
And was there evidence about Purdue's established distribution channels or anything like that that would indicate that even though there was no legal barrier to competition, that in the period

[00:13:42] Speaker 04:
where commercial success was being measured, Purdue's old monopoly, just in an economic sense, was a force for the massive success of Purdue's version of this.

[00:13:56] Speaker 01:
Well, so, first of all, the abuse-resistant tablet was a reformulated oxycontin, which only had two of the same ingredients as the initial

[00:14:06] Speaker 01:
Oxycodone was it was an NDA or under was a new drug application.

[00:14:09] Speaker 01:
It was it wasn't okay and on the existing channels because I mean we don't deny that of course Purdue was in the marketplace here But this was an existential threat if someone had come in developed an abused deterrent form of an extended release Oxycodone as others did and others eventually every time you say existential threat I try to translate that into why that should matter and I'm having a hard time doing it

[00:14:34] Speaker 04:
Um, I, I, I keep focusing on how, um, Purdue sold a lot of this.

[00:14:42] Speaker 04:
Others didn't.

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And I read the district court's use of the term monopoly to mean, well,

[00:14:49] Speaker 04:
You know, the monopoly firm, not legally protected, just it has, you know, all of the outlets in the country or something.

[00:14:56] Speaker 04:
Well, of course it's going to have a lot of sales.

[00:14:58] Speaker 04:
That doesn't tell you very much about whether it was, it was not obvious.

[00:15:02] Speaker 04:
And I'm trying to understand whether there was anything like that.

[00:15:05] Speaker 01:
So I think what my point is that without the development of this patent, sales would have gone to zero.

[00:15:11] Speaker 01:
And so it's true that Purdue had, you know, sales, significant sales beforehand.

[00:15:18] Speaker 01:
But this was existential in the threat that without the development of this, they would have been pulled from the market.

[00:15:22] Speaker 01:
And FDA did pull the original oxycodone from the market.

[00:15:27] Speaker 03:
So the development has- So the success was due to FDA approval of this?

[00:15:32] Speaker 01:
Because of the development of an abuse deterrent formulation, your honor.

[00:15:37] Speaker 01:
And again, others did enter the market.

[00:15:40] Speaker 01:
There was testimony.

[00:15:41] Speaker 01:
There was robust entry and exit in the extended release

[00:15:47] Speaker 01:
oxycodone market.

[00:15:48] Speaker 01:
This is at page 592, 5392 of the appendix.

[00:15:53] Speaker 01:
By 2021, there were six other extended-release oxycodones with abuse deterrent features in the market.

[00:16:00] Speaker 00:
The point is that produced through... The standard release is not one of the claim limitation.

[00:16:06] Speaker 01:
Not the ones that issue here.

[00:16:08] Speaker 01:
That's correct.

[00:16:09] Speaker 01:
And the point is that anyone else could have developed this.

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And if they had to be the first to go to market

[00:16:16] Speaker 01:
with this abuse deterrent feature.

[00:16:19] Speaker 01:
I don't think there's any basis to question that they would have been extremely financially successful given the benefits of this drug when used properly.

[00:16:29] Speaker 00:
I fully appreciate the abuse deterrent factor and the role that that plays in this case.

[00:16:38] Speaker 00:
But I think you rely on this too broadly.

[00:16:42] Speaker 00:
Unlike Judge Cront, I'm having a hard time

[00:16:45] Speaker 00:
fitting into the equation of this case, your terminology on abuse returns.

[00:16:54] Speaker 00:
Every pan is important.

[00:16:57] Speaker 00:
Every pan is a new discovery.

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And there are some that are simple discoveries that have great consequences.

[00:17:06] Speaker 00:
I don't know that we have a way of judging the oh wow type factor of

[00:17:14] Speaker 00:
of a new patent.

[00:17:15] Speaker 00:
And even if we did, I don't see where you have anchored that to any claim limitation.

[00:17:24] Speaker 01:
So, Your Honor, I think what the secondary indicia are looking at is sort of common sense.

[00:17:29] Speaker 01:
It's the way they described it in the Apple case.

[00:17:32] Speaker 01:
Factors that would sort of undermine the conclusion that this was all obvious all along.

[00:17:37] Speaker 01:
And here, I think you have a compelling record for that, because you have a billion dollar product.

[00:17:41] Speaker 01:
You have a grave threat to that product.

[00:17:44] Speaker 01:
a race, trying to develop a solution to that.

[00:17:47] Speaker 01:
And it took many years, nearly a decade, for someone to do it, after hundreds of millions of dollars of investment.

[00:17:54] Speaker 01:
I mean, all of that shows powerfully that this wasn't and couldn't have been obvious all along, or somebody would have done it.

[00:18:01] Speaker 01:
And I think that that's the central teaching of this court's cases.

[00:18:04] Speaker 01:
And I don't think it's hard to imagine a more powerful factual context

[00:18:09] Speaker 01:
for that.

[00:18:10] Speaker 01:
I do want to address the load.

[00:18:12] Speaker 03:
We're out of time.

[00:18:13] Speaker 03:
You are going to go rest on your briefs.

[00:18:15] Speaker 01:
Thank you, Your Honor.

[00:18:22] Speaker 02:
Good morning, Your Honors.

[00:18:23] Speaker 02:
May it please the court.

[00:18:25] Speaker 02:
I'm going to address the two issues that my friend on the other side addressed.

[00:18:28] Speaker 02:
First, that it was allegedly error to rely on obvious to try.

[00:18:31] Speaker 02:
The district court did not rest its findings on an obviousness to try.

[00:18:35] Speaker 02:
There's a single mention of obvious to try.

[00:18:38] Speaker 02:
That's in Appendix 13, the district court said.

[00:18:40] Speaker 02:
At the very least, in the absence of testimony about other heating tools, it would have been obvious to try an oven.

[00:18:46] Speaker 02:
But as Judge Sharonto noted, the obvious to try analysis is really when there's no explicit motivation.

[00:18:52] Speaker 02:
Here, there was a clear motivation to use ovens.

[00:18:57] Speaker 02:
Judge Andrews relied on the unrebutted evidence from Dr. Appel that the Bartholomew mechanism and its examples was not scalable.

[00:19:04] Speaker 02:
while ovens were understood to be scalable and commonly used in pharmaceutical manufacturing.

[00:19:09] Speaker 02:
So there was a clear motivation to combine, which they have not challenged as being clearly erroneous.

[00:19:13] Speaker 04:
So why didn't this happen earlier?

[00:19:17] Speaker 02:
Your Honor, I think the key thing here is the chronology.

[00:19:21] Speaker 02:
The Bartholomus reference, which is the basis of our obviousness, was published in February of 2005.

[00:19:28] Speaker 02:
Purdue then visited Grunenthal, learned about the technology from Bartholomus, and within a year filed the application here, doing the simple and obvious modification that we proposed of taking Bartholomus' teaching of heating PEO to make a tamper-resistant tablet.

[00:19:42] Speaker 02:
Bartholomus suggests that it can be done subsequently.

[00:19:45] Speaker 02:
Purdue simply did so using ovens and pan coders.

[00:19:48] Speaker 02:
The record showed that those were commonly used in pharmaceutical facilities.

[00:19:52] Speaker 02:
There would have been a clear reason to use them.

[00:19:54] Speaker 04:
So the period of time for assessing failure of others or even perhaps commercial success during a particular time, but at least failure of others is the period of time that starts with the crucial prior art.

[00:20:11] Speaker 02:
I believe that's correct, Your Honor, in terms of a long felt but unmet need.

[00:20:15] Speaker 02:
The need here was met by Bartholomus.

[00:20:17] Speaker 02:
Bartholomus provided the solution to the crushing problem, the abuse of Oxycontin, make hardened tablets.

[00:20:23] Speaker 02:
And it taught how to do that, heat PDO and make the tablets.

[00:20:26] Speaker 02:
So I think that's absolutely the time frame, Your Honor, because the question here is not what would have been.

[00:20:31] Speaker 04:
Do we have any case law that says something like what I just said?

[00:20:36] Speaker 04:
I vaguely think yes, but I'm

[00:20:40] Speaker 04:
not summoning up a name, is that wrong?

[00:20:44] Speaker 04:
I mean, it makes a kind of logical sense perhaps, but is there some authority for that idea that it may have taken a very long time when it was not obvious to anybody to get to a piece of prior art, but once that was in place, hardly any time elapsed before the now subject to challenge invention came about.

[00:21:08] Speaker 02:
I can't speak to a specific case, Your Honor, but certainly in terms of long felt need doctrine, there is the second part of that, the long felt but unmet need.

[00:21:16] Speaker 02:
So it certainly would be sort of nonsensical if a party could say long felt need shows the non-obviousness of our claims, even though actually this came about in the prior art a year earlier.

[00:21:29] Speaker 03:
What about commercial success?

[00:21:31] Speaker 02:
Yes, Your Honor.

[00:21:32] Speaker 02:
I think the district court correctly addressed commercial success here, because it noted that the demand

[00:21:38] Speaker 02:
was simply the demand for OxyContin.

[00:21:40] Speaker 02:
Both experts agreed that the sales simply transferred from original OxyContin.

[00:21:44] Speaker 03:
But why should that matter?

[00:21:45] Speaker 03:
Because we're not looking at the original OxyContin.

[00:21:49] Speaker 03:
We're talking about this new anti-resistance.

[00:21:53] Speaker 03:
So why don't they get credit for it just because there was this transfer of sales?

[00:21:58] Speaker 03:
Assuming people could no longer get the first kind, it doesn't mean necessarily that they would be transferred to the same maker, to Purdue.

[00:22:07] Speaker 02:
Yes, Your Honor, but I think it rebuts the presumption that the commercial success is due to the merits of the claimed invention.

[00:22:14] Speaker 02:
There was clearly demand for OxyContin, for Oxycodone, and then they failed to tie that success to anything that is novel in this patent over Bartholomus.

[00:22:24] Speaker 03:
Oh, so your answer to commercial success is it's the same people that would have bought the other drug.

[00:22:29] Speaker 03:
They didn't care about the anti-crushing.

[00:22:30] Speaker 03:
It's just the FDA that cared about it, and therefore they don't get entitled to commercial success.

[00:22:35] Speaker 02:
Well, I think it's two things, Your Honor.

[00:22:37] Speaker 02:
First, I think the record shows that people were buying OxyContin, regardless of whether it was reformulated.

[00:22:43] Speaker 02:
So certainly people were buying it in the industry.

[00:22:45] Speaker 02:
But I think the key point here is it has to show non-obviousness over Bartholomos.

[00:22:50] Speaker 02:
And so what is driving the sales has to not only be claimed in the patent, but be novel over what's in the prior art.

[00:22:56] Speaker 02:
So even if we say, yes, the abuse deterrent feature was driving sales, that's exactly what's taught in Bartholomos.

[00:23:02] Speaker 02:
Bartholomos teaches

[00:23:03] Speaker 02:
forming the hardened tablet.

[00:23:04] Speaker 02:
It teaches forming the tablet that is resistant to gels and is therefore resistant to syringability.

[00:23:11] Speaker 02:
So their expert admitted he hadn't even attempted to tie the sales of commercial success to anything in the specific claims here, which as Judge Raina noted, do not even claim any abuse to turn features.

[00:23:21] Speaker 02:
There's no claim

[00:23:22] Speaker 02:
language relating to hardness or syringability, but regardless, those were taught in Bartholomew's.

[00:23:28] Speaker 03:
Can I take you back to where you began about obvious to try?

[00:23:32] Speaker 03:
Let's assume, I heard you quote the sentence that the district court didn't necessarily rely on that.

[00:23:39] Speaker 03:
Let's assume that we read his opinion as relying on an obvious to try.

[00:23:43] Speaker 03:
is your argument that you two are each talking about different problems to be solved and that's where there's disparity in the arguments for obvious to try in terms of whether there's a finite number of solutions.

[00:23:54] Speaker 02:
Yes, Your Honor.

[00:23:55] Speaker 02:
I think the key point is, again, they're ignoring Bartholomew's.

[00:23:59] Speaker 02:
They're saying, well, if you ignore everything and we go back to, say, 2000, there would have been lots of avenues a person still could have investigated.

[00:24:06] Speaker 02:
But the question here is, viewing Bartholomew's, Bartholomew's teaching the heated PEO tablet and suggesting that subsequent heating can be used, what are the options for subsequent heating?

[00:24:17] Speaker 02:
And there were three, which Dr. Appel testified to, ovens, hand coders, and fluid beds.

[00:24:22] Speaker 02:
And the district court noted this in Appendix 13, that Purdue had not argued there was any other natural choice for heating at a scalable way.

[00:24:33] Speaker 02:
Purdue had not argued that there was any sort of infinite options.

[00:24:37] Speaker 02:
There were three, which is certainly quite finite, Your Honor.

[00:24:42] Speaker 02:
And I wanted to briefly touch on the repeated arguments that everyone was trying and failing to do this.

[00:24:47] Speaker 02:
There's simply no evidence in the record of this, Your Honor.

[00:24:51] Speaker 02:
Two alleged failures were first Accord.

[00:24:54] Speaker 02:
And I want to be clear about what happened in that case.

[00:24:59] Speaker 02:
Your honor, Accord was simply taking a different formulation, which was made by Develco, which was a drug-coated pellet.

[00:25:07] Speaker 02:
And that was perfectly successful when Develco did it on a particular coating pan.

[00:25:11] Speaker 02:
They transferred it to a different facility.

[00:25:13] Speaker 02:
And they didn't get the dissolution profile they were hoping for, because the angle

[00:25:18] Speaker 02:
of the coating pan, the coating spray, was different.

[00:25:21] Speaker 02:
It had nothing to do with the issues we're talking about in this case, in terms of making a drug abuse deterrent, in terms of modifying Bartholomus to heat at scale.

[00:25:31] Speaker 02:
The only other alleged failure was Opana.

[00:25:33] Speaker 02:
As we cited in the record, Opana is a different drug.

[00:25:36] Speaker 02:
It's oxymorphone.

[00:25:37] Speaker 02:
It's a more potent drug.

[00:25:39] Speaker 02:
There's no evidence in the record about how Opana was made, about how its abuse deterrent features related.

[00:25:44] Speaker 02:
or differed from that of reformulated OxyContin.

[00:25:48] Speaker 02:
So all we know is simply that the FDA made the determination that it was not, the benefits of Opana being on the market did not outweigh the risks.

[00:25:55] Speaker 02:
As the Cicero article noted, that was entirely plausible, that that was simply that oxymorphone was a more potent drug and that it drove people to abuse it no matter how difficult it was to do so, or that the type of people who abused that drug simply were willing to go through the efforts.

[00:26:10] Speaker 02:
So it did not demonstrate that it would have been non-obvious to do what we proposed here, which is to take Bartholomos and heat it subsequently.

[00:26:18] Speaker 02:
If Your Honors have any more questions, I'm happy to answer.

[00:26:20] Speaker 02:
But I know it's been a long day.

[00:26:21] Speaker 02:
I'm happy to cede my time.

[00:26:36] Speaker 03:
I don't know where we were in your time, but I guess you've got several.

[00:26:40] Speaker 03:
We'll give you three minutes of rebuttal.

[00:26:41] Speaker 01:
Thank you, Your Honors.

[00:26:44] Speaker 01:
On the period of time, Your Honor, I don't think you could start with Bartolomas.

[00:26:47] Speaker 01:
I think you would start with the problem that people were trying to solve, and that was the grave problem of abuse which began in the early 2000s, many years before Bartolomas.

[00:27:01] Speaker 01:
And here, too, it's undisputed

[00:27:03] Speaker 01:
own experts said this at 5704 to 05, that there was definitely a long felt but unmet need that was solved here.

[00:27:12] Speaker 01:
And I think that answers any questions about the timing.

[00:27:15] Speaker 01:
And in fact, although he suggests that we came up with this just a few months after we visited Grunenthal, we had been working on it for years.

[00:27:23] Speaker 01:
And he points to Bartolomeos.

[00:27:25] Speaker 01:
Grunenthal had Bartolomeos.

[00:27:26] Speaker 01:
Bartolomeos worked there.

[00:27:28] Speaker 01:
But they tried

[00:27:29] Speaker 01:
400 different batches, 900 different formulations.

[00:27:32] Speaker 01:
When did Purdue have Bartalan House?

[00:27:36] Speaker 01:
I'm not the man.

[00:27:37] Speaker 01:
Yeah, it visited then.

[00:27:40] Speaker 01:
I think it might have been 2005, Your Honor.

[00:27:43] Speaker 01:
I forget the exact date.

[00:27:45] Speaker 01:
Is it right that your application was filed?

[00:27:48] Speaker 01:
It came in several months later, Your Honor.

[00:27:50] Speaker 01:
But again, we weren't building off of what we... Bartalan House, that visit was only one small part of the process.

[00:27:57] Speaker 01:
We've been working on this for years, trying many different things.

[00:28:00] Speaker 01:
And here you had which polymer to use, whether to use a polymer, PEO, how to heat it.

[00:28:06] Speaker 01:
And that's why Bartolomeo didn't help here.

[00:28:09] Speaker 01:
He used subsequent compression.

[00:28:11] Speaker 01:
The genius here was heating without compression, which is something that a quartzome witness said with PEO, you'd expect a result in a puddle.

[00:28:23] Speaker 01:
I just want to reach

[00:28:25] Speaker 01:
mentioned the low ABAC patents briefly because they are important.

[00:28:28] Speaker 01:
This court's prior decision, again, the court indicated that Purdue could avoid an obviousness problem with respect to these patents by claiming the removal of 8A itself, which was the discovery that the district court here itself recognized was a surprisingly important component of the solution, rather than just the end result, coming up with an oxycodone with low levels of 14 hydroxys.

[00:28:53] Speaker 01:
So I think it would be

[00:28:54] Speaker 01:
surprising and certainly unfortunate for the court today to hold it after Purdue had done what this court and the district court in Oxycontin said could avoid an obvious misdetermination, nevertheless resulted in obvious misdetermination.

[00:29:07] Speaker 01:
And doing this against the whole discovery of the problem jurisprudence, this was not, Purdue not only discovered the problem, low levels of 14 hydroxy, but the source of the problem.

[00:29:19] Speaker 01:
This 8 alpha, which the district court again, it said, was surprisingly important.

[00:29:23] Speaker 04:
Can I ask, is there, you devote almost your whole brief to the first patent, very small part to the second.

[00:29:33] Speaker 04:
Is there something about the real world difference between the two patents that differentiates them in terms of impact or something?

[00:29:42] Speaker 01:
So the first set, the lower-level patents expire earlier, Your Honor.

[00:29:47] Speaker 01:
That's one thing.

[00:29:49] Speaker 01:
But frankly, the legal error there is very clear and discreet.

[00:29:53] Speaker 01:
We devoted more time to the abuse deterrent because it was a more nuanced analysis with many different errors.

[00:29:59] Speaker 01:
I think both are extremely important to this product and to the ingenuity that went into developing these solutions.

[00:30:07] Speaker 03:
Thank you, Your Honor.

[00:30:08] Speaker 03:
Thank you both sides.

[00:30:09] Speaker 03:
The case is submitted.

[00:30:10] Speaker 03:
That concludes our proceedings.