[00:00:46] Speaker 03:
Our second case this morning is number 1654, Purdue Pharma versus M. Neal Pharmaceuticals.

[00:00:53] Speaker 03:
Mr. Castanhas.

[00:00:55] Speaker 04:
Yes, good morning, your honors, and may it please the court.

[00:00:58] Speaker 04:
The newspapers every morning seem to have reports of opioid and opiate abuse.

[00:01:05] Speaker 04:
This has been characterized as a scourge.

[00:01:08] Speaker 04:
It's been characterized as an epidemic.

[00:01:10] Speaker 04:
Now, extended release oxycontin, which is the product at issue here, extended release oxycontin contains a large amount of produced powerful pain reliever, which is enough for 12 or more hours of continuous pain relief.

[00:01:24] Speaker 04:
When the extended relief version was put on the market for the first time, abusers quickly realized that they could crush or dissolve this extended release formulation and get an immediate and powerful high.

[00:01:37] Speaker 04:
The result of this were addictions, overdoses, and deaths.

[00:01:41] Speaker 00:
It's not insignificant, is it, that that was on the market for a fair bit of time before, I'm not quite sure what the right language is, before the problem of that abuse became very, very well known.

[00:01:59] Speaker 00:
I'm remembering, I guess, and correct me if I'm wrong, because it's not an insignificant consideration in your so-called objective indicia.

[00:02:07] Speaker 00:
feature that not really before 2000 was there significant publicity about this?

[00:02:17] Speaker 04:
That was when, according to the record here, the extent of the Oxycontin abuse had peaked.

[00:02:26] Speaker 04:
As even my friends in their brief on the other side say, though, opioid and opiate abuse has been a problem for centuries.

[00:02:34] Speaker 04:
But it was in response to that peak.

[00:02:37] Speaker 04:
that this invention came about.

[00:02:39] Speaker 00:
Right.

[00:02:40] Speaker 00:
But your long-felt need argument does depend on the word long.

[00:02:45] Speaker 00:
And my recollection of the record is that it really wasn't until 2000 that there began to be significant recognition.

[00:02:54] Speaker 00:
And then you got into the act in 2001, and poof, you had a solution.

[00:02:59] Speaker 04:
Look, with regard to long-felt need, I would say that the need has been felt for a while.

[00:03:05] Speaker 04:
to have some sort of abuse deterrent formulation, but the need became most urgent in 2001.

[00:03:13] Speaker 04:
But when we get to secondary considerations, which I hope to, by starting with obviousness and then concluding with indefiniteness, I hope that you'll see that there are other more powerful secondary considerations in this case.

[00:03:26] Speaker 03:
But on the prima facie case issue, it was well known

[00:03:32] Speaker 03:
to add gels to compounds to prevent abuse, right?

[00:03:40] Speaker 03:
And what you're suggesting is, well, that was for immediate-release tablets rather than for controlled-release, no?

[00:03:49] Speaker 04:
Well, so Judge Dike, I think this takes me right to where I want to go with regard to the Cremafacia case, and that's the Bastin reference.

[00:03:55] Speaker 04:
As you point out quite correctly, gelling

[00:03:59] Speaker 04:
to prevent abuse was known at least as far back as the 1975 Sean Hoffmeister references.

[00:04:07] Speaker 04:
The use of PEO to control release was known as well.

[00:04:14] Speaker 04:
The case that was made by the trial court and by our friends on the other side of the trial court was that, well, it was just an obvious invention waiting to happen.

[00:04:24] Speaker 04:
But if this was so well known for so long, other than the peaking of the market being the only reasonable explanation for it, why was it that people didn't come with it, come up with it?

[00:04:34] Speaker 04:
And the answer, I think, can be found in Bastin.

[00:04:37] Speaker 03:
Yes, Your Honor.

[00:04:37] Speaker 03:
You're saying it's a teaching away in Bastin.

[00:04:40] Speaker 03:
But that was a different medication and a different additive, right?

[00:04:47] Speaker 04:
It was a different medication and a different additive.

[00:04:50] Speaker 04:
But let's take a look at what the district court found in Bastin.

[00:04:53] Speaker 04:
was that it actually taught the combination.

[00:04:56] Speaker 04:
It actually implies was the language that Judge Stein used, and I think that's at page A77.

[00:05:03] Speaker 04:
And what he relied upon, and this is in the third volume of the appendix, the small one, at page A79490.

[00:05:10] Speaker 04:
This is at page five of the Baskin Reference at the bottom, and it's in a paragraph that begins in contrast.

[00:05:20] Speaker 04:
He relies, as my friends on the other side do, on lines 29 through 35 of that reference.

[00:05:26] Speaker 04:
And I'll read that to you so that we have the context.

[00:05:28] Speaker 04:
Which page are you on?

[00:05:29] Speaker 04:
This is page five of the reference.

[00:05:31] Speaker 04:
It's A79490.

[00:05:32] Speaker 04:
And it is in the bottom paragraph.

[00:05:46] Speaker 04:
And this is the language relied upon by the trial court.

[00:05:49] Speaker 04:
In contrast,

[00:05:50] Speaker 04:
A combination of the active drug substance and gelling agent in the same layer has the disadvantage.

[00:05:55] Speaker 04:
First word, disadvantage, important to note, that the gelling action is likely to retard the release of the drug.

[00:06:01] Speaker 04:
And then here's the language that the district court found compelling.

[00:06:04] Speaker 04:
In a manner similar to some known sustained release products, which include water-swellable, high molecular weight polymers to retard drug release.

[00:06:13] Speaker 04:
So that's the end of the quote that's relied upon.

[00:06:15] Speaker 04:
And that's what the district court thought suggested that for an extended release,

[00:06:20] Speaker 04:
So it'd be perfectly good.

[00:06:21] Speaker 04:
But he didn't look at the next sentence.

[00:06:24] Speaker 04:
Reduction of the gelling agent concentration to a level which would not inhibit release of the drug substance severely limits the abuse resistance potential of the tablet.

[00:06:35] Speaker 04:
Now what does that mean, severely limit?

[00:06:37] Speaker 04:
Now let's turn to another part of Bastin, which we argued, but the district court did not read.

[00:06:44] Speaker 04:
And this is important because this court's rules say that you look to the reference in its entirety.

[00:06:49] Speaker 04:
Look at Table 4, which is also in our reply brief at page 10.

[00:06:54] Speaker 04:
Table 4 tells us about that single-layer tablet and the sort of severely limited release.

[00:07:01] Speaker 04:
With the gelling agent in the tablet, 50% of the drug came out after two hours, and no further release up to 12 hours.

[00:07:10] Speaker 04:
No further release.

[00:07:11] Speaker 04:
That's not controlled release.

[00:07:12] Speaker 04:
That's no release.

[00:07:14] Speaker 03:
That's why this teaches away.

[00:07:15] Speaker 03:
But he had in front of him, did he not, testimony that someone skilled in the art would have easily figured out how to accommodate the use of the gel together with the controlled release feature.

[00:07:28] Speaker 03:
And he made a finding that there was not

[00:07:34] Speaker 03:
discouragement to doing that.

[00:07:37] Speaker 03:
We have to review those findings based on a clearly erroneous standard and so why isn't there support for his view that the Baston reference and knowledge of someone skilled in the art could accommodate the use of the gel in a controlled release formulation.

[00:07:59] Speaker 04:
Well, first of all, the answer is that we're not shrinking away from the clear error standard here.

[00:08:03] Speaker 04:
I think the court should be left with a definite and firm conviction that he made a mistake by not reading the entirety of Baston.

[00:08:10] Speaker 04:
And with regard to what... We don't know.

[00:08:12] Speaker 03:
He didn't read.

[00:08:13] Speaker 03:
He just didn't mention.

[00:08:14] Speaker 04:
Well, he didn't.

[00:08:15] Speaker 04:
But I think this would have been very important language, especially in light of the fact that we pointed it out to him and in light of the fact that... Well, you did point it out to him.

[00:08:23] Speaker 01:
And we did.

[00:08:24] Speaker 01:
Absolutely.

[00:08:24] Speaker 01:
So he was aware of it.

[00:08:25] Speaker 01:
He was.

[00:08:26] Speaker 01:
So the fact that he didn't...

[00:08:28] Speaker 01:
Conclude that it was as important as you say it is was a matter of judgment call on his part Which factors into the question of whether there was clear error?

[00:08:39] Speaker 04:
Well, I think Judge Plager with with respect I think that the failure to to consider all of the aspects of the reference that we mentioned and instead to only consider the parts of

[00:08:49] Speaker 01:
Well, my point simply is you did call all of that to his attention.

[00:08:55] Speaker 01:
We did, absolutely.

[00:08:56] Speaker 01:
So he had to have considered it.

[00:08:58] Speaker 01:
At least he heard it.

[00:09:00] Speaker 04:
He heard it, but he did not read the reference for everything that it discloses.

[00:09:06] Speaker 04:
He didn't come out your way.

[00:09:08] Speaker 04:
And I think that particularly with regard to the fact that if you look at page A6199 of the record, you'll see that Judge Stein at trial

[00:09:17] Speaker 04:
was particularly concerned about Baston.

[00:09:19] Speaker 04:
He says this.

[00:09:21] Speaker 04:
And our friends at Amniel on the other side point out, when he says that he's concerned, that they had not even addressed it in their testimony.

[00:09:29] Speaker 04:
The only testimony about the content of Baston and whether or not it teaches a way comes from our expert, Dr. Davies.

[00:09:35] Speaker 04:
The implication or the inference that Judge Stein drew, and that's his language, it says that it implies that.

[00:09:42] Speaker 04:
is strictly him giving it his own reading.

[00:09:45] Speaker 03:
But he didn't read the whole thing.

[00:09:46] Speaker 03:
Suppose we are not taken with the argument that because he didn't mention it, he didn't consider it.

[00:09:53] Speaker 03:
Let's assume we conclude that he had it in front of him, he must have considered it.

[00:09:57] Speaker 03:
What is it that prevents him from reaching the conclusions that he did about the prima facie case of obviousness and the ability of someone skilled in the art to know how to combine

[00:10:11] Speaker 03:
the inhibiting gel together with the controlled release formulation.

[00:10:15] Speaker 04:
Judge Dyke, I would say look at the judge's opinion and look where he finds his motivation to combine.

[00:10:21] Speaker 04:
He finds it in the prior art only from this implication in Baston.

[00:10:26] Speaker 04:
He doesn't find it in any of the so-called gelling references and he can't find it in any of the so-called PEO references.

[00:10:33] Speaker 04:
The only place he finds it is this implication and we say that it's exactly the opposite.

[00:10:38] Speaker 04:
And he only got to that implication by considering part of the reference.

[00:10:42] Speaker 04:
In fact, not just part, but only one sentence when there is data.

[00:10:46] Speaker 03:
I don't recall, maybe I'm mistaken, I don't recall his saying that he wasn't relying

[00:10:52] Speaker 03:
on this testimony that was in front of him about what someone skilled in the art would know how to do.

[00:10:58] Speaker 03:
In fact, I thought he specifically mentioned that in his findings.

[00:11:01] Speaker 03:
Am I mistaken?

[00:11:02] Speaker 04:
No, no, no.

[00:11:04] Speaker 04:
He absolutely did consider that.

[00:11:06] Speaker 04:
But when you weigh the legal conclusion of obviousness against this erroneous finding and the Baston reference considered as a whole, what you see is you see gelling

[00:11:22] Speaker 04:
for control release and gelling for abuse deterrence.

[00:11:27] Speaker 04:
And he says, Bastin says, they live together.

[00:11:30] Speaker 04:
We say, Bastin says, stop.

[00:11:33] Speaker 04:
Don't do that.

[00:11:34] Speaker 04:
Go a different direction.

[00:11:36] Speaker 04:
That is exactly what the clear error standard, whether considered or not, Judge Plater, whether considered or not by the judge.

[00:11:44] Speaker 04:
The simple fact is that this reference cannot be read reasonably.

[00:11:49] Speaker 00:
You mentioned a few minutes ago that the district court in its analysis, its obvious analysis, did not look back to the allegedly anticipatory references.

[00:12:07] Speaker 04:
Is that right?

[00:12:08] Speaker 04:
I don't think that I said that.

[00:12:10] Speaker 00:
What about the set of

[00:12:13] Speaker 00:
We seem to go by many different names.

[00:12:15] Speaker 00:
The 963 patent, the 591.

[00:12:17] Speaker 00:
The 963 and 591.

[00:12:18] Speaker 04:
I mean, neither of those had the gelling to deter abuse.

[00:12:23] Speaker 04:
Neither of them had the viscosity limitations.

[00:12:26] Speaker 04:
The Joshi reference had no control.

[00:12:28] Speaker 00:
I don't remember, but do they talk about gelling and controlled release, and whether those are like oil and water and they don't mix, or maybe they might mix?

[00:12:39] Speaker 04:
Well, they talk about using the PEO for controlled release.

[00:12:43] Speaker 04:
But they don't talk anything about using it to deter abuse to keep it from being sucked up into the hypodermic needle or to be snorted.

[00:12:52] Speaker 04:
So there is art on both sides of the equation here, on the abuse deterrent side, on the one hand, and on the controlled release side.

[00:13:02] Speaker 04:
Bastin says don't mix them together.

[00:13:04] Speaker 04:
They don't work together.

[00:13:05] Speaker 04:
They'll trap it.

[00:13:06] Speaker 04:
It'll keep the drug from ever getting released.

[00:13:09] Speaker 04:
That's the main point on our prima facie case.

[00:13:12] Speaker 03:
On our secondary concern... But the gel was used to control release, right?

[00:13:17] Speaker 03:
Absolutely.

[00:13:19] Speaker 03:
Well, so why would it be inconsistent to use gel in a controlled release formula?

[00:13:23] Speaker 04:
Because what Bastin tells you is that the amount of gelling that it takes to control release is not compatible with the amount of gel that it takes to deter abuse.

[00:13:32] Speaker 04:
That's exactly what that sentence at the end of the portion that was not quoted by the district court says.

[00:13:38] Speaker 04:
I'm already into my rebuttal time I haven't even mentioned secondary considerations other than my colloquy with Judge Toronto or the indefinite issue indefinite this issue which I'm happy to leave to the briefs but on secondary considerations perhaps I should say the following two points first of all the epidemiological studies that produce submitted to the FDA showed that this was a game changer with regard to reducing abuse it actually diverted

[00:14:04] Speaker 04:
abusers away from using oxycontin and unfortunately to other drugs sometimes.

[00:14:09] Speaker 04:
But it was a huge success in that regard.

[00:14:12] Speaker 04:
These are the abusers who now cannot get this up their nose or into their arm.

[00:14:17] Speaker 04:
The FDA, I think, is even more important here because the FDA's recognition of this invention as a game changer, as one that changed the risk benefit calculus and

[00:14:31] Speaker 04:
They recognized that the old version of Oxycontin was removed from the market for safety considerations.

[00:14:36] Speaker 04:
They would not approve generics of the old Oxycontin to compete.

[00:14:42] Speaker 00:
How do you fit that into, this is kind of a combined question, what secondary consideration, and sometimes that can be a list connect

[00:14:52] Speaker 00:
seemingly disconnected from the underlying inquiry, but more importantly, how do you connect that as a logical evidentiary matter to the question whether this would have been obvious or not?

[00:15:05] Speaker 04:
Absolutely.

[00:15:05] Speaker 04:
So first of all, KSR says any secondary consideration.

[00:15:09] Speaker 04:
This court has traditionally looked to commercial success

[00:15:12] Speaker 04:
in an ordinary competitive free market as the sort of thing.

[00:15:15] Speaker 00:
Well, and I assume that's because if there's great commercial success, it tells you something about the incentive that relevant skilled artists would have had to discover it, and the fact that they didn't tells you maybe it wasn't all that obvious.

[00:15:27] Speaker 00:
Connect the FDA decision.

[00:15:29] Speaker 00:
Sure.

[00:15:30] Speaker 04:
So first of all, with regard to the invention here, the invention here is not a personal good.

[00:15:35] Speaker 04:
It's not something that either a legitimate user or an abuser wants necessarily.

[00:15:41] Speaker 04:
This is a public good.

[00:15:42] Speaker 04:
So it's the FDA that's looking out for the public good here.

[00:15:45] Speaker 04:
They're making this determination.

[00:15:47] Speaker 04:
And they're making a determination that now takes old Oxycontin and its potential generics out of the picture.

[00:15:56] Speaker 04:
It's no longer on the market.

[00:15:58] Speaker 04:
It recognizes that old Oxycontin was removed from the market because of these safety considerations.

[00:16:04] Speaker 04:
And it becomes such an invention that the FDA gives for the first time in its history.

[00:16:11] Speaker 04:
labeling that recognizes the abuse deterrent effects of this drug.

[00:16:17] Speaker 04:
The purpose of the secondary consideration analysis is, as the Supreme Court and Graham and so many other cases from this court have made clear, it is to check judges, and I would dare say lawyers also, who may not be the experts in the area.

[00:16:34] Speaker 04:
But this is the way that objective people.

[00:16:36] Speaker 00:
Let me put my question this way.

[00:16:38] Speaker 00:
assume for purposes of this question that what the FDA did here is confirmation that the reformulated OxyContin is so much better on the safety efficacy profile than original OxyContin that it took original OxyContin off the market.

[00:16:54] Speaker 00:
You wouldn't let generics and you dropped your thing.

[00:16:57] Speaker 00:
So in terms of

[00:17:00] Speaker 00:
objective improvement to what was available in the market.

[00:17:04] Speaker 00:
This was a giant thing.

[00:17:06] Speaker 00:
Connect that to non-obviousness.

[00:17:09] Speaker 04:
Connect that to non-obviousness?

[00:17:12] Speaker 04:
Yeah.

[00:17:13] Speaker 04:
We built a better mousetrap.

[00:17:14] Speaker 04:
The FDA recognized it.

[00:17:15] Speaker 00:
That is exactly what the non-obviousness... But if the recognition for the need for it didn't come up until the day before you figured it out, why is that, as an evidentiary matter, connected to non-obviousness?

[00:17:28] Speaker 04:
You're coming fairly close to saying to me that long-felt need is a necessity for a claim of non-obviousness.

[00:17:38] Speaker 04:
Whether this was a long-felt need or it was a short-felt need, it was a desperate need.

[00:17:44] Speaker 04:
And it was filled, and it was filled against the advice of the art, which was what Bastin told.

[00:17:52] Speaker 04:
And ultimately, not just the approval and the withdrawal, but

[00:17:58] Speaker 04:
the abuse deterrent labeling.

[00:17:59] Speaker 04:
This is something that other drug manufacturers tried to get and didn't get.

[00:18:04] Speaker 04:
We got it for the first time ever.

[00:18:06] Speaker 04:
That was a recognition that this truly was a game changer.

[00:18:10] Speaker 00:
It is objective evidence from disinterested parties that says this is... I'm sorry, I'm not getting the reference to other drug companies tried to get and didn't get.

[00:18:18] Speaker 04:
I'm sorry, I didn't hear the last part.

[00:18:20] Speaker 00:
You said something about other drug companies tried to get and didn't get.

[00:18:23] Speaker 00:
What are you referring to?

[00:18:24] Speaker 04:
Other drug companies tried to get both

[00:18:26] Speaker 04:
At least after, I know at least of, I believe it was Endo with regard to its drug, Opana, tried to get abuse deterrent labeling and did not achieve that.

[00:18:37] Speaker 04:
This was the first time the FDA ever did that.

[00:18:40] Speaker 04:
That is a remarkable achievement.

[00:18:43] Speaker 04:
I believe also the amicus reflux.

[00:18:45] Speaker 03:
It's not the first time that people had used gels to control abuse.

[00:18:50] Speaker 04:
No, but it is the first time that people used gels to control abuse in a controlled release drug.

[00:18:56] Speaker 04:
And that was so important here because the controlled release was not just one hour of pain relief, but 12 continuous hours of pain relief.

[00:19:04] Speaker 04:
That's the invention here.

[00:19:05] Speaker 04:
It's the combination.

[00:19:07] Speaker 04:
Controlled release, abuse deterrence.

[00:19:11] Speaker 04:
Again, I go back and I say, Mastin said stop.

[00:19:13] Speaker 01:
No matter how clever it was, it's still a question as to exactly how that relates to the question of non-obviousness under the statute.

[00:19:26] Speaker 01:
I'm having somewhat the same problem.

[00:19:29] Speaker 01:
It is a secondary consideration.

[00:19:31] Speaker 01:
Is it not?

[00:19:32] Speaker 01:
We call them secondary for a reason.

[00:19:35] Speaker 04:
They are, except that you also have case law.

[00:19:38] Speaker 04:
Transocean is one case that comes immediately to mind that says they always have to be considered.

[00:19:44] Speaker 04:
You have a number of opinions pointing out that sometimes, and I would say here, it is at least as powerful evidence of innovation.

[00:19:52] Speaker 04:
Remember that obviousness is ultimately you're just looking for the presence

[00:19:56] Speaker 04:
of something we know it's not because it overcame 102.

[00:20:01] Speaker 04:
So is this under 103 something that should be granted?

[00:20:05] Speaker 04:
Is this the sort of thing that we want to innovate, that we want to encourage, that we want to reward with the grant of a limited exclusionary right?

[00:20:15] Speaker 04:
I would put forth that given all of the value of this invention, as recognized in the marketplace by the regulator,

[00:20:22] Speaker 04:
The answer to that question clearly has to be yes.

[00:20:26] Speaker 01:
Don't fail to read this morning's Washington Post as a front page article on the newest abusive drug that has nothing to do with your product.

[00:20:36] Speaker 01:
Your product may no longer be relevant.

[00:20:41] Speaker 04:
I'll get back to newspapers after this argument.

[00:20:43] Speaker 04:
Thank you.

[00:20:44] Speaker 03:
All right, we'll give you two minutes for remodel.

[00:20:46] Speaker 02:
Thank you, Your Honor.

[00:20:47] Speaker 03:
Mr. Maloro?

[00:20:49] Speaker 02:
Thank you, Your Honor.

[00:20:52] Speaker 02:
May it please the court.

[00:20:53] Speaker 02:
The judgment of the district court should be affirmed.

[00:20:57] Speaker 02:
This is a judgment which was entered after a five-day trial.

[00:21:01] Speaker 02:
Nine witnesses testified.

[00:21:05] Speaker 02:
And the court issued something like 63 pages of findings of facts.

[00:21:10] Speaker 00:
Can I ask you about Bastin?

[00:21:11] Speaker 00:
Did Bastin, in describing its use of, is it the same jail as

[00:21:19] Speaker 00:
is claimed or some gel?

[00:21:21] Speaker 02:
Bastin has a different gel.

[00:21:24] Speaker 00:
Did he structure the use of the gel in the pill in a particular way that wouldn't or would generalize to the problem of stopping release after two hours?

[00:21:39] Speaker 02:
There's no specific structuring in Bastin's.

[00:21:43] Speaker 02:
There was a table, which counsel referred to in his argument,

[00:21:47] Speaker 02:
in which the gel was part of an immediate release tablet.

[00:21:51] Speaker 02:
And in that case, the drug stopped going out.

[00:21:54] Speaker 00:
I guess I'm trying to, to the extent that you can explain this to me, and there's both a you and a me in that, what is it about the problem that Table 4 identified?

[00:22:08] Speaker 00:
in Baston that was overcome here.

[00:22:13] Speaker 00:
Is gel used in a different way, not layers with a kernel, or something, or what?

[00:22:20] Speaker 02:
So the problem, so to speak, with respect to the table was that you had an immediate release tablet.

[00:22:25] Speaker 02:
It wasn't a controlled release tablet.

[00:22:27] Speaker 02:
And so the object was to have immediate release of the drug.

[00:22:31] Speaker 02:
What Judge Stein found is that if you wanted to have a sustained release version of the drug,

[00:22:37] Speaker 02:
you would have the gel to modulate the properties, the release of the drug.

[00:22:43] Speaker 02:
And the prior art exactly taught that.

[00:22:45] Speaker 02:
There were other references, the Royce reference, for example, which Judge Stein discussed, specifically taught using PEO, the exact gelling agent here, as something that could modulate the release of the drug.

[00:22:58] Speaker 00:
I'm trying to get one layer down to some level of technical detail that I can imagine.

[00:23:05] Speaker 00:
What did your experts say?

[00:23:08] Speaker 00:
about why Bastian didn't teach away from trying to get controlled release using this gel?

[00:23:17] Speaker 02:
Essentially, it was the paragraph that counsel referred to at page 79490, and it was specifically the effects of the gel that they could retard the release of the drug

[00:23:38] Speaker 02:
which would happen in a sustained release agent.

[00:23:40] Speaker 00:
But I assume at trial they saw that.

[00:23:43] Speaker 00:
They looked at table four.

[00:23:44] Speaker 00:
It retarded the release so much that after two hours there was no more release.

[00:23:51] Speaker 00:
They're thinking, that's a bad thing.

[00:23:53] Speaker 00:
It's fine for immediate release.

[00:23:56] Speaker 00:
It's a bad thing if you want controlled release.

[00:23:59] Speaker 00:
Did your experts say, oh, no, no, no.

[00:24:01] Speaker 00:
That's not the only way you can use gel.

[00:24:03] Speaker 00:
People would not have been deterred from trying to create a 12-hour Oxycontin drug by reading Baskin.

[00:24:11] Speaker 00:
And if so, what did your experts say about why they wouldn't be deterred?

[00:24:16] Speaker 02:
Because of the teachings of the prior art in Royce and Hofmeister and Shaw,

[00:24:21] Speaker 02:
that's specifically taught.

[00:24:23] Speaker 02:
And there are curves where you can look at the release of drug with PEO modulating it.

[00:24:31] Speaker 02:
So we have, for example, the Zhang dissertation that the court referenced in its opinion and the Zhang article, which teach that PEO was a widely used agent for controlled release.

[00:24:43] Speaker 02:
And you can actually look at the curves that one skilled in the art can adjust the amount of PEO or the type of PEO

[00:24:50] Speaker 02:
to get the release of drug that you want.

[00:24:53] Speaker 03:
So is it quite apart from other substances which might control the release?

[00:24:58] Speaker 03:
The prior art taught that the use of gel alone could be used to control the release.

[00:25:04] Speaker 02:
That's exactly right, Your Honor.

[00:25:06] Speaker 02:
Royce is a good example of that.

[00:25:08] Speaker 02:
The Zhang article is a good example of that.

[00:25:10] Speaker 02:
Judge Stein carefully analyzed all those prior art references and found that one skilled in the art

[00:25:17] Speaker 02:
would have known, would have been motivated to use PEO, would have been motivated to use it in a sustained release dosage form, and would have been motivated to use it to solve the abuse problem.

[00:25:29] Speaker 02:
The Joshi reference, for example, which Judge Stein referred to in his opinion, that Joshi reference taught specifically the use of PEO as a gel to prevent abuse of pharmaceutical formulations.

[00:25:43] Speaker 02:
So here what we had was a known problem,

[00:25:45] Speaker 02:
motivation to solve that problem, known predictable techniques for solving the problem, and no unexpected results, not even really an allegation of unexpected results here, and secondary considerations that the court found didn't support a finding of non-obviousness here.

[00:26:03] Speaker 00:
Just to take one example, you referred to Royce several times.

[00:26:05] Speaker 00:
Can you point to me where in Royce something says,

[00:26:11] Speaker 00:
the end product you're trying to get is one that provides, that affirmatively provides controlled release, and not just control in the sense of stopping it after a short period, but having release of the drug for an extended period.

[00:26:30] Speaker 00:
Think about using a drug.

[00:26:33] Speaker 02:
Yes, Your Honor.

[00:26:34] Speaker 02:
Royce begins at A83-985.

[00:26:37] Speaker 02:
Yes.

[00:26:39] Speaker 02:
And if you look to

[00:26:41] Speaker 02:
column 3, around line 39, you see that sustained release dosage forms may be prepared from the higher molecular weight polymers, e-molecular weight greater than about 300,000.

[00:27:02] Speaker 02:
And there's reference to polyox in the parenthetical there.

[00:27:09] Speaker 02:
And if you continue down,

[00:27:11] Speaker 02:
It goes on to talk about contemplating mixtures of the polymers, and the mixtures may comprise respective amounts of various polymers, as shall be within the skill of the worker.

[00:27:26] Speaker 00:
Thank you.

[00:27:29] Speaker 02:
The Zhang article at A45726

[00:27:37] Speaker 02:
If we go to A45731, we can see there are two figures there.

[00:27:58] Speaker 02:
Figure four.

[00:27:59] Speaker 00:
45731?

[00:28:00] Speaker 00:
45731.

[00:28:01] Speaker 02:
Thank you.

[00:28:06] Speaker 02:
And we can see

[00:28:09] Speaker 02:
The influence in figure four of the legends is the influence of molecular weight of PEO on the release of CPM from tablets.

[00:28:18] Speaker 02:
Your actual experimentation, where one skilled in the art can modify the PEO to get the release they want.

[00:28:24] Speaker 02:
This was well within the level of skill in the art.

[00:28:26] Speaker 02:
This is exactly the evidence that Judge Stein considered, carefully commented on.

[00:28:32] Speaker 02:
This was a ruling, a judgment that

[00:28:35] Speaker 02:
The rulings went both ways in the case.

[00:28:37] Speaker 02:
There were some defenses that were rejected by the court, other defenses that the court credited.

[00:28:43] Speaker 02:
There was some evidence from defense experts that was not credited by the court.

[00:28:47] Speaker 02:
There was other evidence that was.

[00:28:51] Speaker 01:
There was obviously evidence on both sides of many of these contentious issues.

[00:28:57] Speaker 01:
But there is no question that their product attained remarkable commercial success.

[00:29:05] Speaker 01:
In fact, their former product went off the market altogether, and they were able to market this new formulation widely.

[00:29:17] Speaker 01:
And those of us who have broken a leg in the last year or two may have had the benefit of it.

[00:29:25] Speaker 01:
That's pretty impressive evidence that they came up with something that nobody else had yet.

[00:29:32] Speaker 01:
perhaps not thought of, but perhaps been able to figure out how to do.

[00:29:37] Speaker 02:
Well, with respect to the sales of the product, there were high sales.

[00:29:42] Speaker 02:
Judge Stein recognized that.

[00:29:44] Speaker 02:
On the issue of commercial success, there was no connection.

[00:29:48] Speaker 02:
The evidence didn't support a connection between the patented features and the sales.

[00:29:53] Speaker 00:
I'm kind of baffled by this, and I kind of think I'm missing something.

[00:30:00] Speaker 00:
The reformulated OxyContin has so much better a safety efficacy profile that the FDA basically said, you can only do this.

[00:30:09] Speaker 00:
You can't even do the old OxyContin.

[00:30:13] Speaker 00:
How could the commercial success, even assuming we're going to isolate it from the actual 103 issue that it's about, not be attributable to that?

[00:30:25] Speaker 00:
It's so much better, and this is what's different about it.

[00:30:29] Speaker 02:
because the sales of the product were the same with and without the safety feature.

[00:30:34] Speaker 02:
So if we're talking commercial success, there was no demand for those patented features.

[00:30:40] Speaker 02:
As a matter of fact, Purdue recognizes that had the generics been allowed to come on the market with the original Oxycontin,

[00:30:46] Speaker 02:
They would have taken tremendous steps.

[00:30:49] Speaker 00:
I guess I keep thinking that we're getting caught up in thinking about secondary considerations as if it's a set of individual silos unrelated to the evidentiary inquiry.

[00:31:00] Speaker 00:
Now, the fact is that this product had so much better a safety efficacy profile from what came before that the government regulator said

[00:31:09] Speaker 00:
You can't even sell the old stuff anymore.

[00:31:11] Speaker 00:
And nobody else can either.

[00:31:13] Speaker 00:
It's that much better.

[00:31:14] Speaker 00:
Major contribution to the public good.

[00:31:19] Speaker 00:
What do we do with that fact in the obviousness analysis?

[00:31:23] Speaker 02:
Judge Stein recognized and credited that fact.

[00:31:25] Speaker 02:
And he put it into the, using the lists that the cases identify, he put it into the claim category.

[00:31:33] Speaker 02:
So he recognized that there was some acclaim associated with the invention.

[00:31:38] Speaker 02:
that flows from the FDA's actions.

[00:31:40] Speaker 02:
This was not something where he couldn't fit it into a bucket and he ignored it.

[00:31:44] Speaker 02:
He recognized the evidence.

[00:31:46] Speaker 02:
But the evidence was counterweighed by the strong technical evidence of obviousness here, the predictable results that were achieved with the known techniques, and the fact that the other secondary considerations, when you looked at the commercial aspect, the sales aspect here, there was no nexus to the claimed invention.

[00:32:07] Speaker 02:
There was no skepticism.

[00:32:08] Speaker 02:
The inventor testified he couldn't identify any skepticism here.

[00:32:13] Speaker 02:
The FDA's actions were not deemed to be evidence of skepticism.

[00:32:19] Speaker 02:
It was just the FDA doing its job, waiting for data and then approving the labeling for the abuse avoidance and taking the old product off the market.

[00:32:28] Speaker 03:
Is the weighing of the prima facie case and the secondary considerations, once they've been identified,

[00:32:36] Speaker 03:
a legal issue or a factual issue?

[00:32:40] Speaker 02:
I think there's a component of both there.

[00:32:42] Speaker 02:
The strength of the relative evidence is going to be highly factually dependent.

[00:32:47] Speaker 02:
And the findings of fact on the strength of the technical case, the findings of fact on the lack of secondary considerations as a whole, that's all highly fact bound.

[00:32:59] Speaker 02:
At the end of the day, there clearly is a legal question on obviousness once you have all your facts

[00:33:06] Speaker 02:
pulled together, but here the way to solve it.

[00:33:08] Speaker 03:
So if you say that even though there are some secondary considerations cutting against obviousness that's outweighed by a strong prima facie case, that's a legal determination?

[00:33:19] Speaker 02:
No, I believe that that's more factual than legal.

[00:33:22] Speaker 02:
Because the particular considerations, I don't think this is a sort of a checkbox exercise where you determine is there a prima facie case, is there a secondary consideration or not,

[00:33:36] Speaker 02:
And then once you get done, you just weigh in a legal fashion the check boxes.

[00:33:42] Speaker 02:
This is one where the evidence supporting all of those aspects of the obviousness analysis is highly factual.

[00:33:51] Speaker 02:
And so the ultimate legal conclusion, even with respect to the balancing, has to take into account the fact findings and the determinations that are made as to not just the existence of that evidence, but the relative strength of it.

[00:34:09] Speaker 03:
OK.

[00:34:10] Speaker 03:
Anything further?

[00:34:11] Speaker 03:
Any further questions?

[00:34:12] Speaker 03:
Yes, sir.

[00:34:14] Speaker 03:
OK.

[00:34:14] Speaker 03:
I did nothing further.

[00:34:15] Speaker 03:
Pass the vote.

[00:34:16] Speaker 03:
Thank you, Mr. Morell.

[00:34:17] Speaker 03:
Mr. Costanzos, you have two minutes.

[00:34:32] Speaker 04:
Thank you, Your Honor.

[00:34:33] Speaker 04:
I think it's possible that either I have misspoken or miscommunicated in my opening argument, because one of my colleagues

[00:34:39] Speaker 04:
pointed out to me that baston does concern analgesics.

[00:34:41] Speaker 04:
I think the question to me might have been whether baston concerned other drugs.

[00:34:46] Speaker 04:
That's clear at A79484 in the abstract.

[00:34:49] Speaker 04:
And of course, it's responding to Hofmeister, which is one of those 1975 references, which is directed to analgesics.

[00:34:56] Speaker 03:
Judge Roth, yes?

[00:34:58] Speaker 03:
If this gel is used to control the release, why would it be

[00:35:07] Speaker 03:
startling that one would use the gel in a controlled release formulation, which is what you're suggesting.

[00:35:16] Speaker 04:
That's not what's startling.

[00:35:17] Speaker 04:
What's startling is the ability to use that gel in order to not only control the release but also to deter abuse.

[00:35:27] Speaker 04:
That goes back to our argument about Baston.

[00:35:29] Speaker 03:
I'm sorry, I'm a little confused.

[00:35:31] Speaker 03:
Because on the one hand, it was used to control the release.

[00:35:34] Speaker 03:
On the other hand, it was used to deter abuse.

[00:35:37] Speaker 03:
So why is combining the two of them inconsistent?

[00:35:41] Speaker 04:
For exactly the reason that we pointed out with regard to Baston.

[00:35:45] Speaker 04:
Baston suggested, and again, I'll bring you back to the particular page, but it's that sentence that comes at the end of what was relied upon by the district court.

[00:35:56] Speaker 04:
that reduction of the gelling agent to a concentration to a level which would not inhibit release, in other words, which would avoid that holding it up for the rest of the 12-hour period that Judge Toronto was talking to my friend about, severely limits the abuse resistance potential of the tablet.

[00:36:14] Speaker 04:
That's part of the halt.

[00:36:16] Speaker 04:
Don't combine these two things that's in this reference.

[00:36:19] Speaker 04:
The data that's on page 28 of the reference, it's A79513.

[00:36:24] Speaker 04:
is another example of where the prior art says alt.

[00:36:29] Speaker 04:
When my friend talks about Royce and Zhang, all he's telling you is that there are prior art references that say yes, you can use PEO to control release.

[00:36:39] Speaker 04:
What it doesn't say is that you can use PEO to control release and at the same time also get

[00:36:44] Speaker 04:
the remarkable, game-changing abuse deterrent.

[00:36:48] Speaker 00:
If I remember right, correct me if I'm wrong, that the basic logic of Judge Stein's analysis of this was a skilled artisan would have recognized that the gel has these two possible features, two kind of documented features.

[00:37:05] Speaker 00:
It controls release and it deters abuse.

[00:37:11] Speaker 00:
And then the second piece of the analysis was,

[00:37:14] Speaker 00:
And that would have given skilled artisans a reason to see if they can get both to work at the same time.

[00:37:20] Speaker 00:
And that was just a matter of routine experimentation to get to the right balance.

[00:37:27] Speaker 04:
And if you read Bastin as simply suggesting that that's what you do, then that's how he was able to do it.

[00:37:33] Speaker 04:
Because he thought Bastin was a teaching in favor of that holding.

[00:37:36] Speaker 04:
We say, and I think that the document actually bears this out, Bastin says, no, won't work.

[00:37:42] Speaker 04:
Because if you reduce it,

[00:37:44] Speaker 04:
to a level that will allow the drug to release, it won't have the abuse deterrent effects.

[00:37:49] Speaker 04:
That's what that sentence says.

[00:37:51] Speaker 00:
That's what the data says.

[00:37:52] Speaker 00:
If I remember, Judge Stein did not use the language of obvious to try, right?

[00:37:57] Speaker 04:
He didn't use it, but it certainly seems like he was applying it.

[00:38:00] Speaker 00:
If I want to use that label, the first step seems to me that he said there was enough in the prior art, including Gaston, that made it obvious to try to see if you could get both of these benefits at the same time.

[00:38:12] Speaker 00:
and then the rest was really routine experimentation.

[00:38:16] Speaker 00:
Why is there not enough evidence to support that?

[00:38:19] Speaker 04:
Because Bastin says that it's not going to work.

[00:38:22] Speaker 03:
But you had other testimony from skilled artisans that it would be routine to achieve that proper balance.

[00:38:31] Speaker 04:
Not about Bastin.

[00:38:32] Speaker 04:
Not about Bastin at all.

[00:38:33] Speaker 04:
Those skilled artisans did not consider Bastin.

[00:38:37] Speaker 04:
And again, A6199, and I'll quote Mr. Werner, Amniel's counsel,

[00:38:42] Speaker 04:
I was going to say we never talked about Bastin on direct for what it's worth.

[00:38:46] Speaker 04:
Judge Toronto, you asked my friend about what his experts said about Bastin.

[00:38:50] Speaker 04:
The answer is they didn't say anything about Bastin.

[00:38:54] Speaker 04:
The last two points I have very quickly are the CPDD paper.

[00:38:58] Speaker 04:
which was written two years after the invention here, still didn't come up with this.

[00:39:02] Speaker 00:
It simply said... It's not a very technical paper, right?

[00:39:05] Speaker 00:
It's not a very technical paper, but it is written by technical, by very expert people, including people from... My recollection is that, I don't mean this in a diverted way, it was more sociological than it was about technical choices one might make to solve the problem.

[00:39:22] Speaker 00:
It was about documenting the problem.

[00:39:23] Speaker 04:
Is that... Whether or not that's a fair

[00:39:26] Speaker 04:
Fair conception of the CPDT paper, it also did have two specific suggestions for deterring abuse.

[00:39:32] Speaker 04:
One of which was the addition of antagonists that the liver would filter out if taken orally, but that when crushed would counteract the opioid.

[00:39:41] Speaker 04:
And the other, of course, was controlled release itself, in and of itself, as an abuse deterrent.

[00:39:46] Speaker 03:
OK, I think we're out of time.

[00:39:47] Speaker 03:
OK, thank you very much for your time.

[00:39:48] Speaker 03:
We appreciate it.

[00:39:49] Speaker 03:
Thank you both, counsel, and both cases submitted.