[00:00:13] Speaker 06:
The next case for argument is 141294, Purdue Farmer versus Epic Farmer.

[00:00:20] Speaker 06:
Can we have a little sidebar before you start?

[00:00:23] Speaker 06:
Please.

[00:00:23] Speaker 06:
Just because there's several issues in play and there's several different people arguing, I think I speak for the panel that there's a motion to dismiss that's out there.

[00:00:32] Speaker 06:
All of that information is confidential, except perhaps for certain legal arguments that might be made outside of the context of the specifics of the settlement.

[00:00:42] Speaker 06:
So parties are free to argue that, but our expectation is, given the confidentiality of the settlement agreement, certainly what we will cover today is questions regarding the underlying merits of the case.

[00:00:56] Speaker 06:
Okay?

[00:00:57] Speaker 06:
We all clear?

[00:00:58] Speaker 06:
All right.

[00:00:59] Speaker 06:
Mr. Castigna.

[00:00:59] Speaker 02:
All right.

[00:00:59] Speaker 02:
Thank you, Your Honor, and may it please the Court.

[00:01:03] Speaker 02:
If the panel certainly has any questions about the settlement agreements, I'll do my best to answer them within those restrictions.

[00:01:09] Speaker 02:
My plan today is to proceed on two broad sets of issues.

[00:01:13] Speaker 02:
And if I could just take a brief moment to outline where I plan to go, and you can tell me if I'm going in a different direction than you would like.

[00:01:21] Speaker 02:
First is with regard to what, in this case, are called the three low A buck patents.

[00:01:27] Speaker 02:
The district court's own finding in this case that the A delta molecule was unknown and even unexpected until the Purdue and Rhodes scientists discovered it.

[00:01:36] Speaker 02:
And then that allowed those scientists to apply a remedy that resulted in the first ever low ABUC Oxycodone API, its patentable invention under the Supreme Court's 1923 decision in Eibel Process, which has been recognized not only by this court's predecessors, but even as recently as by this court in Leo Pharmaceuticals.

[00:01:58] Speaker 02:
With regard to the 383 patent, which is the other set of issues in this case, that patent changed the marketplace, and it saved lives.

[00:02:06] Speaker 02:
by achieving a combination of properties in an opioid and opiate dosage form that no one thought could be combined.

[00:02:12] Speaker 02:
Extreme abuse deterring hardness on the one hand, and effective controlled release of the drug on the other.

[00:02:18] Speaker 02:
The core error made by the district court with regard to the 383 patent was in trivializing the problem to be solved as meeting, this is in the court's words, public demand for a hard tablet, which improperly went into the primer art, the inventor's solution.

[00:02:34] Speaker 02:
The solution was combining abuse deterrents of whatever kind, and that was what there was demand for with effective control of release.

[00:02:41] Speaker 06:
Okay, why don't we start with the low ABELC patent and your reference and your reliance on ABELC.

[00:02:48] Speaker 06:
Even what difference does it make, pointing to the claims in this spec, whether you've identified 8 alpha or 8 theta, what difference does it make in terms of what you do in the end result and what this claim is really about?

[00:03:01] Speaker 02:
Well, what the claim is really about is a low ABUC Oxycodone API, a safer Oxycodone API, because it avoids the risk that the FDA had identified and that in

[00:03:14] Speaker 02:
Your opinion for the panel in the Chapman v. Cashner case also identified.

[00:03:19] Speaker 02:
Now, Chapman presented a bit of a challenge for us, because on the one hand, with regard to the product claims that are at issue here, we had to claim a product which was free or substantially free, actually substantially free is probably more accurate, of 14-Hydroxy.

[00:03:38] Speaker 02:
But in your opinion for the court,

[00:03:40] Speaker 02:
in Chapman, in this court's opinion in Chapman, which was unpublished, nonetheless, we have to honor it, because it's part of the St.

[00:03:46] Speaker 02:
Patens family.

[00:03:47] Speaker 02:
It faults the claim that was discussed in that case for not including a reference to the 8 alpha molecule.

[00:03:54] Speaker 02:
So how do we solve the problem of claiming the reduction, which is unquestionably new and was found by the district court to be new?

[00:04:05] Speaker 02:
How do we claim that and make sure that we honor Chapman?

[00:04:08] Speaker 02:
Well, the answer is we put in this language derived from 8 alpha.

[00:04:12] Speaker 02:
So the small remaining parts of this 14-hydroxy, at least a part of that, has to be derived from 8 alpha.

[00:04:18] Speaker 02:
My own view is that if Chapman had never occurred, we would have a new and non-obvious product if we had simply claimed low ABUCC oxycodone.

[00:04:27] Speaker 02:
But the simple fact is that the non-obviousness of that invention is demonstrated by

[00:04:33] Speaker 02:
the discovery of the 8-alpha molecule and the ability to deal with it in a way that no one had ever figured out how to deal with it before.

[00:04:40] Speaker 00:
Why does the origin of the 14-hydroxy matter?

[00:04:44] Speaker 02:
Well, the origin of the 14-hydroxy matters because of the way that oxycodone was made before the 8-alpha molecule was discovered.

[00:04:52] Speaker 02:
In all the ways that oxycodone was made, the ABUC

[00:04:57] Speaker 02:
impurity remained in the final product at very high levels, certainly relative to the 25, 15, and 10 parts per million levels that are claimed in these inventions.

[00:05:08] Speaker 00:
But if the purpose of the drug is to have a safe administration and to remove, or the purpose of the pen is to remove all of the 14-hydroxy

[00:05:21] Speaker 00:
And that means is achieved.

[00:05:24] Speaker 00:
Why does it matter where the 14 hydroxy comes from?

[00:05:28] Speaker 02:
Well, it mattered very much because it tells you.

[00:05:31] Speaker 02:
So maybe I should back up here, Judge Rainier.

[00:05:36] Speaker 02:
In so many of this courts and the Supreme Court's obviousness cases, what we're looking for is the presence of invention.

[00:05:45] Speaker 02:
Is there something that just an ordinary artisan couldn't have done before?

[00:05:49] Speaker 02:
And that's idle.

[00:05:51] Speaker 02:
Ibel says that the discovery of a problem that people didn't know about before and the application of a remedy to that problem represents patentable invention.

[00:06:01] Speaker 02:
Ibel used gravity.

[00:06:04] Speaker 02:
It was an observable machine and he used gravity to elevate the wet paper sock that was going into the machine by some

[00:06:12] Speaker 02:
six inches or so, to increase the pitch so that gravity would cause the stock to travel at the same rate as the wire that was pulling the stock into the machine for pressing and drying.

[00:06:23] Speaker 06:
But that was directly related to discovering the reason for doing it.

[00:06:27] Speaker 06:
And I guess I have the same question as Judge Raina did.

[00:06:31] Speaker 06:
What does it matter whether it's 8 alpha or 8 beta when the invention is directed towards getting rid of 14?

[00:06:40] Speaker 06:
Hydroxy.

[00:06:41] Speaker 02:
14 hydroxies.

[00:06:43] Speaker 06:
So what does it make at the end of the day you want to get rid of the 14 hydroxies?

[00:06:47] Speaker 02:
That's right.

[00:06:48] Speaker 06:
How does whether it's 8 alpha or 8 beta, and again I'm just repeating what Judge Rainer was asking about, how does whether it's 8 alpha or 8 beta have anything to do with that?

[00:07:00] Speaker 02:
So I thought I was heading toward an answer with him.

[00:07:02] Speaker 02:
Let me try it this way.

[00:07:04] Speaker 02:
In addition to what I said in response with regard to looking for the non-obvious invention,

[00:07:11] Speaker 02:
8 alpha and 8 beta are different molecules.

[00:07:14] Speaker 02:
They have fundamentally different properties.

[00:07:16] Speaker 02:
8 alpha, once it was discovered, was also discovered to be about 400 times more sensitive to acid.

[00:07:25] Speaker 02:
Now that's what's happening in the hydrogenation step that was being used to create oxycodone in the prior art.

[00:07:34] Speaker 02:
What had to happen, once you know that it's 8 alpha, and you can see this in the patent, A462 column 8 lines 28 to 30, A471 column 26 lines 13 to 18.

[00:07:48] Speaker 02:
You have to make the hydrogenation reaction a more basic one.

[00:07:53] Speaker 02:
You have to add more alkaline elements to it.

[00:07:56] Speaker 02:
You have to increase the pH.

[00:07:57] Speaker 02:
That's another way of putting it.

[00:07:59] Speaker 02:
In addition, you have to use a different

[00:08:04] Speaker 02:
catalyst in the reaction.

[00:08:07] Speaker 02:
And if you don't know that, then all you're going to do is repeat what the produced and wrote science.

[00:08:12] Speaker 00:
So if this isn't as important as you're arguing today, why don't you tailor your claims to the discovery of the 8-delpha?

[00:08:21] Speaker 02:
Oh, we absolutely did.

[00:08:24] Speaker 00:
Well, I don't know.

[00:08:25] Speaker 00:
I mean, it seems to me that what you did is that you discovered, or rather claiming, hydrogenation at the final stage.

[00:08:38] Speaker 02:
Well, actually, hydrogen is hydrogenated again.

[00:08:41] Speaker 02:
Hydrogenation is not claimed in the claims.

[00:08:46] Speaker 02:
Hydrogenation is part of the story.

[00:08:47] Speaker 02:
It's part of the invention story.

[00:08:49] Speaker 02:
What we claim is a product.

[00:08:51] Speaker 02:
And the way that we very carefully, and again, honoring Chapman, the way that we very carefully honored that part of the decision was to say in the claims, derived from 8 alpha.

[00:09:07] Speaker 02:
That is telling the world, and we told the world in our specification, we told the world in our claims, that what we are doing is we are eliminating this down to a vanishing point.

[00:09:16] Speaker 02:
And the only way you can tell is that part of what's left over

[00:09:19] Speaker 02:
is derived from 8 alpha.

[00:09:20] Speaker 02:
And that was part of the infringement analysis also done by the district court, which found infringement.

[00:09:26] Speaker 06:
Going back to the point you were making about somehow you're going to perform a different process and perform it in a different way if you know 8 alphas in play, you kind of made that argument on page 38 of your blueprints.

[00:09:39] Speaker 06:
But I couldn't find anything in the record

[00:09:43] Speaker 06:
where you talk about the 8a, you know, the specific conditions about time and acid amount, et cetera, to run hydrogenation.

[00:09:56] Speaker 06:
I mean, you cite some pages there, but the pages you cite only talk about differences between 8 alpha and 8 theta, not the differences between the hydrogenization process for removing 14 hydroxides.

[00:10:11] Speaker 02:
So I hope, Your Honor, that we've been complete with regard to this issue.

[00:10:19] Speaker 02:
I think if you look at pages 18, 19, 20 in particular of our brief, which is in the statement of the case, under the heading Designing a Novel Solution, what you see there in particular with reference to the chart that we provided for the court at the top of page 19,

[00:10:38] Speaker 02:
which you can compare to the earlier charts, which show the way that oxycodone was made before the Purdue and Rhodes scientist novel discovery, is that you are now doing a different, and this is the way Purdue did it, this is not what the claims say, but this is one of the things that you have to take into account.

[00:10:59] Speaker 02:
You do a second hydrogenation step of the free base, and you do it under different conditions and with a different catalyst.

[00:11:08] Speaker 06:
I'm looking at the chart of 19.

[00:11:11] Speaker 06:
On page 19, is that what you're saying?

[00:11:14] Speaker 06:
That doesn't differentiate between 8 alpha and 8 beta, right?

[00:11:19] Speaker 02:
Well, if taken along with the text that precedes it, it absolutely does, because if you compare, for example, what was thought to be the case,

[00:11:29] Speaker 02:
uh... before him to go away charge of the people what do you think we can't agree to get the text in the brief where we're trying to work what we're trying to do in the section of the brief your honor is to explain to you why eight out there it up for matters for all of the reasons that actually follow this chart and you will see that the uh... under the product of applying the prior arch i brought to the nation where you read where you refer but it would not have a page ninety okay

[00:11:58] Speaker 02:
So we start there, and I'm cognizant that I need to address the 383 patent with my time ticking down.

[00:12:04] Speaker 02:
But with regard to this drawing, what we're now showing, that the second hydrogenation was run longer than usual, for example.

[00:12:18] Speaker 02:
This is a new hydrogenation step, if you compare it by the way to the earlier way.

[00:12:22] Speaker 02:
Yes, step three.

[00:12:23] Speaker 02:
Before, it was just salting.

[00:12:24] Speaker 02:
Now it's salting and hydrogenation.

[00:12:26] Speaker 00:
Before, you didn't have a second hydrogenation.

[00:12:28] Speaker 02:
Exactly, exactly.

[00:12:30] Speaker 02:
And if you don't know that there's 8 alpha in there, all you're going to do is run the same hydrogenation under the same conditions over and over again.

[00:12:38] Speaker 02:
This hydrogenation, as those portions of the patent that I pointed out to you earlier, are done under different conditions, less acidic, more basic, as well as with a different catalyst.

[00:12:48] Speaker 02:
And what we're saying here at the bottom of 19 over to 20, the ordinary artisan would not have applied hydrogenation or any other technique

[00:12:56] Speaker 02:
to the oxycodone salt, as opposed to the oxycodone free base, or under conditions that would stop the continuing conversion of 8-alpha to 14-hydroxy.

[00:13:05] Speaker 02:
The next sentence says specific acid amounts and specific timing of the removal of the catalyst had to be adjusted with regard to the particular properties of 8-alpha.

[00:13:14] Speaker 03:
Is any of that in the claims?

[00:13:15] Speaker 02:
The derived from 8-alpha is the way that it goes in the claims.

[00:13:19] Speaker 02:
And ultimately, the low parts per million of the ABUC impurity is what distinguishes

[00:13:26] Speaker 02:
these claims from what came before, both for novelty purposes and for non-obviousness purposes.

[00:13:33] Speaker 02:
So the answer is yes.

[00:13:35] Speaker 02:
Derived from 8 alpha is in the claims to make very clear that we are getting rid of virtually all of the 8 alpha.

[00:13:43] Speaker 02:
If that derived from 8-alpha was not in the claims, then you could, I suppose, make the argument that, well, as long as you get rid of it from wherever, it doesn't matter.

[00:13:52] Speaker 02:
But as a matter of scientific fact, you have to know 8-alpha.

[00:13:56] Speaker 00:
But you also added the second step of hydrogenation.

[00:14:02] Speaker 00:
And that's what's new in the patent.

[00:14:06] Speaker 00:
It's well known in the art.

[00:14:08] Speaker 00:
The more you watch it, I guess, the more times you go through this step, you end up with the last 14 hydroxies.

[00:14:18] Speaker 02:
Well, that's not exactly true because that's exactly what the prior art tried and failed to do.

[00:14:24] Speaker 02:
Because 8-beta, which was hydrogenated under very different circumstances, in much more acidic conditions and without the specific removal of the catalyst that I've tried to

[00:14:34] Speaker 02:
explained in my colloquy with Chief Judge Prost, that was trying to extend the hydrogenation longer and longer.

[00:14:41] Speaker 02:
The definition of insanity, I believe, is trying the same thing over and over and expecting to get different results.

[00:14:46] Speaker 02:
More hydrogenation didn't get rid of the 14-hydroxy, and it never happened.

[00:14:50] Speaker 03:
Isn't it obvious that at some point someone was going to try it at the later stage, at the salting stage?

[00:14:57] Speaker 02:
I don't know if your question is about whether it was going to inevitably be discovered, and I'm not sure that that's ever been a case that's been made.

[00:15:06] Speaker 03:
Is there anything clearly erroneous in the district court's finding that everybody in the art knew that hydrogenation

[00:15:13] Speaker 03:
reduced the level of 14-hydroxy, and the longer you did it, you would expect to see less of it.

[00:15:20] Speaker 02:
Well, if that's the final effect of the district report, then absolutely that's clearly erroneous because hydrogenation of

[00:15:27] Speaker 02:
doing it over and over, reduced it temporarily, but then it came back in the salting step.

[00:15:32] Speaker 00:
Well maybe doing it over and over at the same stage would be insane, but trying it at the salting stage or after the salting stage.

[00:15:40] Speaker 02:
And no one knew until Purdue and Rhodes that the 8 alpha was reappearing.

[00:15:45] Speaker 02:
But a skilled artisan would know.

[00:15:47] Speaker 02:
No, no, no, the skilled artisans didn't know because they were trying, the skilled artisans were trying and failing.

[00:15:54] Speaker 03:
What is clearly erroneous about a finding that one of ordinary skill and the art would in the ordinary uses common sense eventually have tried it at step three?

[00:16:06] Speaker 02:
Well, the question is what is it?

[00:16:10] Speaker 02:
Well, hydrogenation in and of itself doesn't solve the problem.

[00:16:14] Speaker 02:
That is part of the point of why it's essential to know that 8-alpha is there.

[00:16:19] Speaker 00:
You say it's essential at what stage you do the hydrogenation?

[00:16:24] Speaker 02:
Well, you have to hydrogenate it when it's present so that you are getting rid of it.

[00:16:30] Speaker 02:
So if it's going to reappear after salting, then yes, you have to hydrogenate after salting.

[00:16:34] Speaker 02:
and if it and i have been touched the yeah i want to give you two minutes more to discuss that thank you thank you very much your honor uh... with with regard to three three uh... the uh... the holding against us was both on anticipation grounds and obvious on anticipation we've made our point in our brief uh... disclosure of uh...

[00:17:04] Speaker 02:
or the description of analgesics such as two NSAIDs and acetylamine.

[00:17:10] Speaker 06:
Does the main argument here is that McGinty didn't deal with an opiate?

[00:17:15] Speaker 02:
McGinty didn't deal with an opiate, and it didn't deal at all with crushing strength or making something hard.

[00:17:20] Speaker 02:
It was strictly about control and release.

[00:17:23] Speaker 06:
And the district court found that every analgesic on the market in a sustained release form at the time of the McGinty application was an opiate.

[00:17:31] Speaker 02:
The district court did find that, and that is clearly erroneous with regard to the record, because there were, in fact, a broader set of analgesics, which were not opioids that were on the market at the time.

[00:17:45] Speaker 02:
And we've cited that in our brief.

[00:17:48] Speaker 06:
With regard to obviousness... So it's not every, but it's most, many?

[00:17:53] Speaker 06:
Some.

[00:17:54] Speaker 02:
Some.

[00:17:55] Speaker 02:
I believe that there were two or three, and I believe one of them was an opioid.

[00:17:59] Speaker 02:
But of course, the point of McGinnity was to bring controlled release to a wide variety, 19 different categories of kinds of drugs.

[00:18:07] Speaker 02:
But with analgesics, the only things that were disclosed as and the like were three things that are nowhere near opioids.

[00:18:14] Speaker 02:
If I told you to go get me an aspirin or a Tylenol or something like that, and I came back with oxycodone, no one would say, oh yeah, you got me what I wanted.

[00:18:24] Speaker 02:
And that's our point with regard to anticipation.

[00:18:27] Speaker 02:
With regard to obviousness, our point is basically this.

[00:18:30] Speaker 02:
If we thought McGinnity, the McGinnity reference, was going to solve the twin problems of abuse deterrence through a hard tablet, as well as effective controlled release, we'd still be sitting here waiting.

[00:18:45] Speaker 02:
There's nothing in there that would cause an ordinary artisan to even look at McGinnity to find a solution for hardness.

[00:18:52] Speaker 02:
And with that and with the observation that the tests which are argued against us by Dr. Muzio were done on a non-oceoid and they were done not in complete agreement with example three of the McGinnity reference.

[00:19:10] Speaker 02:
because there was no evaluation of shear rate.

[00:19:13] Speaker 00:
The court found that hardness or breaking strength was inherent in the reference.

[00:19:21] Speaker 00:
What's your response to that?

[00:19:22] Speaker 02:
Well, our response to that is that that has to be clear error because inherency is a very strict test.

[00:19:28] Speaker 02:
And the first thing is that Dr. Muzzio didn't even test an opioid.

[00:19:32] Speaker 02:
He tested an antihistamine.

[00:19:34] Speaker 02:
So I don't know how we can know that that McGinnity not only

[00:19:39] Speaker 02:
describes opioids but also inherently describes the formulation with an opioid in it that is always going to be hard.

[00:19:47] Speaker 03:
Did you present a contrary analysis for your expert?

[00:19:51] Speaker 02:
We did not.

[00:19:51] Speaker 02:
We did not present contrary testing.

[00:19:53] Speaker 02:
We presented contrary testimony with regard to his testing because quite frankly we didn't know what we would be able to test given

[00:20:01] Speaker 02:
The lack of any disclosures or descriptions in the community with regard to either hardness or opioids.

[00:20:08] Speaker 02:
Unless the court has further questions at this point, I'll return on rebuttal.

[00:20:11] Speaker 06:
Thank you.

[00:20:12] Speaker 06:
We'll restore two minutes.

[00:20:13] Speaker 06:
And to try to keep it even, Mr. Schumann, why don't we add two minutes to your time, which will give you a total of 11, and then Smellon will add two minutes to give you 13 minutes to try to even it out.

[00:20:25] Speaker 01:
Appreciate that, Your Honors.

[00:20:26] Speaker 01:
Good morning.

[00:20:27] Speaker 01:
My name is Mark Schuman.

[00:20:28] Speaker 01:
I'm at the police of court.

[00:20:29] Speaker 01:
I'm representing the EPILEE Teba Pharmaceuticals today.

[00:20:32] Speaker 01:
We've split the arguments up based upon the interest of our parties.

[00:20:35] Speaker 01:
I'm going to take the 383 patent today.

[00:20:38] Speaker 01:
And I can also address issues with regard to the settlement, the mootness issue, the motion to dismiss that Teba has filed as well, if you want to talk about that.

[00:20:47] Speaker 06:
Tell us about the 383 and the two points your friend made about the deficiencies prior.

[00:20:53] Speaker 01:
Sure.

[00:20:54] Speaker 01:
Let's start with the...

[00:20:57] Speaker 01:
with the anticipation argument.

[00:20:59] Speaker 01:
So there is an allegation on appeal that there is a reference, a Stapiro reference, and they cite table 56.5 that allegedly contains another sustained release analgesic.

[00:21:16] Speaker 01:
And they claim for the first time on appeal that there's a third analgesic that has sustained release.

[00:21:22] Speaker 01:
And so the district court's finding

[00:21:25] Speaker 01:
that there were two sustained release products on the market that were analgesics, and both of those were opioids is in error.

[00:21:33] Speaker 01:
So that's the setup for this argument.

[00:21:36] Speaker 01:
The response is as follows.

[00:21:39] Speaker 01:
Dr. Block, the expert for Teva, who the district court relied on specifically in his testimony, looked at this table in Depiro 56.5.

[00:21:51] Speaker 01:
in starting his testimony, and I'll direct the court's attention to A3372.

[00:21:58] Speaker 01:
And he specifically starts by looking at the DePuro handbook, and he references both tables 56.5 and 56.7.

[00:22:08] Speaker 01:
Those are tables dealing with both opiate... What volume is this, sir?

[00:22:14] Speaker 00:
You've got big volumes of...

[00:22:15] Speaker 01:
That's a good question, Your Honor.

[00:22:18] Speaker 01:
At the top of each volume are the page numbers.

[00:22:21] Speaker 01:
I can read it for you if you want.

[00:22:23] Speaker 01:
I know that the court's loathe to do that.

[00:22:26] Speaker 01:
But let me just start with the question.

[00:22:30] Speaker 01:
The question on page 83372.

[00:22:33] Speaker 01:
And they list two tables, 56-5 and 56-7, non-oipic opioids, and we'll be to the next page, opioid analgesics.

[00:22:44] Speaker 01:
The answer, yes.

[00:22:45] Speaker 01:
All right, now I notice also that you have oxycodone highlighted on the slide.

[00:22:51] Speaker 01:
Why is that?

[00:22:52] Speaker 01:
Oxycodone is one of the most widely used opioid analgesics.

[00:22:57] Speaker 01:
Why is that important?

[00:22:59] Speaker 01:
And then he goes on to talk about this book and the tables.

[00:23:02] Speaker 01:
And Dr. Block concludes a few pages later, and I won't go through all of that because of our time concerns, but this is the testimony that district court relies on.

[00:23:10] Speaker 01:
Dr. Block concludes, after looking at these tables, both of them,

[00:23:14] Speaker 01:
that one skilled in the art would conclude that there were two analgesics that were available in sustained release form.

[00:23:22] Speaker 01:
One of them is morphine and one of them is oxycodone.

[00:23:26] Speaker 01:
And then he goes on to further conclude that of those two, oxycodone was essentially the elephant in the room.

[00:23:34] Speaker 01:
It was the biggest product.

[00:23:35] Speaker 01:
It was the one that would come immediately to mind to one skilled in the art because it was the most prescribed drug in that class.

[00:23:43] Speaker 01:
It was the one that was being abused.

[00:23:45] Speaker 01:
It was the most prominent drug.

[00:23:47] Speaker 01:
And so these are the findings the district court made.

[00:23:50] Speaker 01:
And I want to add, there was no cross-examination of Dr. Block on this.

[00:23:57] Speaker 01:
No one came up and said, now, Dr. Block, we see that you talked about table 56.5, and there seems to be some sustained release of the proxen product there.

[00:24:07] Speaker 01:
Why didn't you count that?

[00:24:09] Speaker 00:
So your argument is that a skilled artisan is not a major leap to go from analgesic to oxycodone?

[00:24:17] Speaker 01:
He wouldn't have considered it.

[00:24:18] Speaker 01:
A skilled artisan would consider that there are two, morphine and oxycodone.

[00:24:22] Speaker 01:
For some reason, and we don't know why, because there was no cross-examination, this table 56.5 does not fall within the purview of what one skilled in the art would consider.

[00:24:33] Speaker 01:
I further add that they didn't put their own expert on to testify about this table.

[00:24:37] Speaker 01:
The first time we hear about this table,

[00:24:39] Speaker 01:
is on appeal.

[00:24:41] Speaker 01:
In an appellate argument, they want judges and lawyers to interpret this table when one skilled in the art has already done so at the district court level.

[00:24:50] Speaker 01:
Furthermore, let's assume they're right.

[00:24:54] Speaker 01:
Let's assume there are three and not two.

[00:24:57] Speaker 01:
Is that reversible error?

[00:25:01] Speaker 01:
They have to not only show factual error, but they need to show reversible error.

[00:25:04] Speaker 01:
Now, I'm not conceding that it's factual error, because it's not.

[00:25:08] Speaker 01:
The only uncontroverted evidence in the record comes from Dr. Block that there were two, and he took into account this table.

[00:25:17] Speaker 01:
But let's assume that's wrong, and there were three.

[00:25:19] Speaker 01:
The testimony still is that oxycodone was the elephant in the room, and one skilled in the art would have been drawn to that product.

[00:25:27] Speaker 01:
And so, under the NRA Petering case,

[00:25:30] Speaker 01:
there still would have been inherent participation.

[00:25:33] Speaker 01:
There was no reversible error on this point.

[00:25:36] Speaker 03:
Was McGinty in front of the PTO during the prosecution of 383?

[00:25:40] Speaker 01:
It was, but in a very limited sense.

[00:25:43] Speaker 01:
Obviously, McGinty was there for what it taught, but not for what was inherent in it.

[00:25:49] Speaker 01:
And most of the trial that we had was about what was inherent in McGinty.

[00:25:54] Speaker 01:
A lot of the testing that Dr. Muzio did about the hardness,

[00:25:57] Speaker 01:
a lot of the inherent testimony from those skilled in the art, both for and against on both sides.

[00:26:03] Speaker 01:
Those things were not in front of the Patent Office, and so the presumptions that attach to the teachings of McGinnity with regard to the patentability of the 383 patent really don't apply, I think, very strongly because the evidence simply was not there in front of the Patent Office.

[00:26:20] Speaker 01:
Now, let me turn to the other error, and that is the error with regard to the

[00:26:26] Speaker 01:
the obviousness case.

[00:26:32] Speaker 06:
Wait, you're not conceding there was error.

[00:26:34] Speaker 06:
You said, let me turn to the error.

[00:26:35] Speaker 01:
Well, the error that was alleged with regard to obviousness.

[00:26:38] Speaker 01:
And that is the fact that McGinnity somehow does not lead to obviousness.

[00:26:44] Speaker 01:
And it's interesting to note, you heard my opponent say that if we were going to wait for McGinnity, we would never have an abuse to turn property.

[00:26:56] Speaker 01:
The McGinnity application, the US version of it, turned into a patent called the 963 patent, which is orange book listed for the Purdue product today.

[00:27:06] Speaker 01:
It was in a lawsuit.

[00:27:07] Speaker 01:
It was settled in the settlement documents that you have in front of you.

[00:27:13] Speaker 01:
It is a viable product.

[00:27:15] Speaker 01:
It is a viable product for oxycodone.

[00:27:21] Speaker 01:
That's the simple answer to this.

[00:27:23] Speaker 01:
McGinnity solved the problem.

[00:27:24] Speaker 01:
It solved it before.

[00:27:27] Speaker 01:
It was anticipating, and it also rendered the patent obvious, by the way, as well.

[00:27:33] Speaker 01:
The district court did not err in those regards.

[00:27:38] Speaker 03:
What's your understanding of what the district court found in the Concerta tablet that might arguably not be present in McGinnity?

[00:27:48] Speaker 03:
I was unclear what the obviousness combination is or what role Concerta was playing.

[00:27:54] Speaker 01:
Concerta is more or less, your honor, a straw man that's been constructed here on appeal.

[00:28:01] Speaker 01:
Concerta is real world confirmation of what the district court found.

[00:28:08] Speaker 01:
So let me back up a minute.

[00:28:09] Speaker 01:
The district court found that the prior art relating to polyethylene oxide would solve the problem that was identified.

[00:28:18] Speaker 01:
So the problem here was that oxycodone was being abused by crushing.

[00:28:22] Speaker 01:
People would crush it, and they would chew it, swallow it.

[00:28:24] Speaker 01:
They would crush it and inject it.

[00:28:26] Speaker 01:
They would crush it and snort it.

[00:28:28] Speaker 01:
Whatever they did to abuse it, they started by crushing it.

[00:28:31] Speaker 01:
The judge found that was the obvious problem.

[00:28:34] Speaker 01:
The solution, obviously, and supported by evidence, was to make it harder.

[00:28:40] Speaker 01:
The known problem based on excipients that were used by those skilled in the art was to look for a hard excipient.

[00:28:46] Speaker 01:
One of those was polyethylene oxide.

[00:28:48] Speaker 01:
Even the testimony of plaintiffs' own

[00:28:52] Speaker 01:
own witnesses, fat witnesses, their head of therapeutics, Dr. Mannion, for instance, testified that as early as the 60s, it was known that polyethylene oxide was hard.

[00:29:04] Speaker 01:
And there was much evidence, we said it in our brief, I won't take the time, that everyone knew polyethylene was hard, and they knew that it would make a tablet that had controlled release properties.

[00:29:14] Speaker 01:
On top of that, other people began using it by hot melt extruding it.

[00:29:19] Speaker 01:
They began putting it through these extruders to put heat and pressure on it, and the tablet got hard, and they still got these properties that would control release.

[00:29:29] Speaker 01:
So one skilled in the art, according to district court, would follow this path and find a hard tablet that would sustain release.

[00:29:36] Speaker 01:
And you end up ultimately with McGinnity, which was the end of the trail of all this prior art.

[00:29:42] Speaker 01:
So this is the analysis the District Court went through.

[00:29:45] Speaker 01:
Now, Concerta gets inserted in this analysis as real-world evidence of this.

[00:29:51] Speaker 01:
What happened was there happened to be a drug, Concerta, which is methylphenidate.

[00:29:56] Speaker 01:
It's an ADHD drug.

[00:29:58] Speaker 01:
And this was abused by people.

[00:29:59] Speaker 01:
They would crush it up and snort it or swallow it.

[00:30:02] Speaker 01:
But it turned out when they put it in a longer-lasting product, this Oros type of product, there was less abuse.

[00:30:11] Speaker 01:
And it was known through a number of the testimony.

[00:30:14] Speaker 01:
One of the gentlemen was Gupta that we cited in our brief.

[00:30:19] Speaker 01:
It was known that it had two properties that thwarted abuse.

[00:30:23] Speaker 01:
One was that it was hard.

[00:30:25] Speaker 01:
And the other is if you added water to it, it gelled.

[00:30:29] Speaker 01:
Now, why do I mention that?

[00:30:31] Speaker 01:
The briefs makes a mention that if it wasn't hard, it gelled.

[00:30:35] Speaker 01:
Well, it did both.

[00:30:37] Speaker 01:
We had two patents down below.

[00:30:39] Speaker 01:
Two patents.

[00:30:40] Speaker 01:
The 314 patent, which you're not seeing on appeal, was a gelling patent.

[00:30:45] Speaker 01:
It was a PEO patent that said when you added water, it gelled and floated abuse.

[00:30:49] Speaker 01:
And the other one said PEO makes it hard.

[00:30:52] Speaker 01:
So we put in evidence of both, and the Concerta says both.

[00:30:56] Speaker 01:
It makes it hard, and it also gelled.

[00:30:58] Speaker 01:
And they say that the district court erred because conservative wasn't hard.

[00:31:03] Speaker 01:
It gelled.

[00:31:04] Speaker 01:
Well, actually, it's both.

[00:31:06] Speaker 01:
And you'll look at the record, you'll see evidence of both.

[00:31:09] Speaker 01:
I hope that answers your question, Your Honor.

[00:31:14] Speaker 01:
Settlement agreement.

[00:31:16] Speaker 01:
I would suggest if you're going to look at the settlement agreement, you look at it as a simple settlement agreement with a license as the first pass.

[00:31:24] Speaker 01:
and then start looking at the embellishments, the consent decrees, and all the other documents.

[00:31:29] Speaker 01:
Think about that.

[00:31:31] Speaker 01:
In a settlement agreement with a license.

[00:31:34] Speaker 00:
You aren't even in a settlement.

[00:31:36] Speaker 00:
I'm not sure that we can say anything.

[00:31:38] Speaker 00:
I mean, it's confidential, isn't it?

[00:31:40] Speaker 01:
I think that in general terms, I don't know.

[00:31:42] Speaker 01:
So how can I ask you a question or respond to what you're saying?

[00:31:46] Speaker 01:
That's fine if you don't.

[00:31:48] Speaker 01:
I'm perfectly happy to leave it at that.

[00:31:51] Speaker 06:
Thank you.

[00:31:51] Speaker 01:
Thank you, Your Honor.

[00:31:52] Speaker 06:
I appreciate it.

[00:32:06] Speaker 05:
May it please the court?

[00:32:07] Speaker 05:
Barbara Mullen on behalf of AMNEO.

[00:32:09] Speaker 05:
AMNEO is actually here on appeal of a judgment based on collateral estoppel and not applied to the invalidity judgment from the TEP trial.

[00:32:18] Speaker 05:
And since the court seems to be interested in that obvious determination, I'll address that first.

[00:32:25] Speaker 05:
I think the first problem with Purdue's argument is that we have a fundamental disconnect between what is claimed and what they claim to be their invention.

[00:32:33] Speaker 05:
They have said repeatedly today and in their briefs that their invention is using a second hydrogenation step on the oxycodone salt.

[00:32:40] Speaker 05:
That is not what is claimed.

[00:32:42] Speaker 05:
In fact, in argument today, it was pointed out that the claim is actually to a low ABUC oxycodone API.

[00:32:50] Speaker 05:
It's not a process claim.

[00:32:52] Speaker 05:
You can search in vain in these patents and the asserted claims for any reference to a second hydrogenation step that's performed on the oxycodone salt.

[00:33:02] Speaker 05:
And that's really what distinguishes this case from Ible processing.

[00:33:07] Speaker 05:
In the Ible processing court case, the inventor invented a machine, a machine that was the remedy to the problem.

[00:33:16] Speaker 05:
And he claimed that machine.

[00:33:19] Speaker 05:
He didn't claim the paper that was made as a result of the machine.

[00:33:24] Speaker 05:
He claimed the machine that solved the problem.

[00:33:28] Speaker 05:
Purdue has not claimed the remedy or what it claims now or says now actually solves the problem of a high level 14 hydroxy.

[00:33:36] Speaker 06:
Well, their argument is, and maybe you can address this, your friend on the other side referred repeatedly to Chapman as if Chapman set up a roadmap for us.

[00:33:47] Speaker 06:
if you specifically call out A alpha, you're there, and that's what's missing.

[00:33:54] Speaker 06:
What is your view of that?

[00:33:55] Speaker 05:
Well, Chatham was method claims.

[00:33:57] Speaker 05:
And again, that goes back to what they're saying here.

[00:33:59] Speaker 05:
They have invented a new method of reducing 14-hydroxy levels, which involves hydrogenating an oxycodone salt.

[00:34:07] Speaker 05:
But the claims here are not method claims.

[00:34:10] Speaker 05:
They're product claims, or product by process claims.

[00:34:14] Speaker 05:
And so when you have a product claim, what you're looking at is, for example, does the 8 alpha make a difference?

[00:34:22] Speaker 05:
And it doesn't matter whether in the end product, the low level of 14-hydroxy, whether that 14-hydroxy came from 8 alpha, 8 beta, or some other community.

[00:34:31] Speaker 06:
Well, your friend says that there are different properties to the 8 alpha, so that timing and amounts of acid and other things would be different once you recognize that you've got 8 alpha as opposed to 8 beta.

[00:34:42] Speaker 06:
Is that correct?

[00:34:44] Speaker 05:
I didn't mean to interrupt.

[00:34:47] Speaker 05:
You can search in vain in the patents for any of those specific catalysts or reaction properties.

[00:34:53] Speaker 05:
If you look actually at the 799 patent to which he was referring, and if you look at page in the appendix, if you look at page A461,

[00:35:10] Speaker 05:
You'll see that the patent does not distinguish in the description between 8-alpha and 8-beta.

[00:35:15] Speaker 05:
If you look at about line 54... With column 5 or 6?

[00:35:20] Speaker 05:
Column 5, pardon me.

[00:35:23] Speaker 05:
The term 8-14-dihydroxy-7-8-dihyde-2 of codeinone includes either 8-alpha, 8-beta, or mixtures of both.

[00:35:35] Speaker 05:
So when the description goes on, it's talking generically about alpha, 8 alpha, 8 beta, or both.

[00:35:42] Speaker 05:
The only place in the patent where 8 alpha is called out specifically is in the figure.

[00:35:48] Speaker 05:
If you look at figure 2, which is at page A455, it shows the way you dehydrate 8 alpha is by H plus acid.

[00:36:02] Speaker 05:
There's nothing there about time, about catalyst, about reaction conditions.

[00:36:08] Speaker 05:
There's just nothing there.

[00:36:09] Speaker 05:
And that's the only place in these patents where they distinguish between what you do for 8 alpha and what you do for 8 beta, or a mixture of the both.

[00:36:17] Speaker 05:
And in fact, the conditions that will dehydrate 8 alpha will also, as the district court found, dehydrate 8 beta.

[00:36:24] Speaker 05:
So it's the same conditions that you're going to use for the reaction.

[00:36:28] Speaker 03:
What does the district court say about eyeball process?

[00:36:32] Speaker 05:
I don't think I have a process that's specifically addressed in the District Court opinion.

[00:36:38] Speaker 05:
It was raised very briefly in, I think, their reply brief after trial, if I recall correctly.

[00:36:45] Speaker 03:
So what should we do?

[00:36:46] Speaker 03:
I think you're right that probably he didn't address it, or at least I haven't found it.

[00:36:50] Speaker 03:
Right.

[00:36:51] Speaker 03:
Where did that leave this court?

[00:36:52] Speaker 03:
What should we do about that?

[00:36:55] Speaker 05:
Well, I think it's the

[00:36:57] Speaker 05:
I mean, it's a case.

[00:37:00] Speaker 05:
I think you can consider the tenets of it, but I think they don't apply here for the reasons that I've discussed, but is that Eibel was really talking about, and there are other cases that talk about the idea that if you identify a problem that was unknown, and you remedy that problem, and you patent the remedy

[00:37:20] Speaker 05:
then it may be an inventive act.

[00:37:21] Speaker 05:
But in all of those cases, they actually look at what is claimed to determine whether or not it's obvious.

[00:37:27] Speaker 05:
And what is actually claimed here is not the supposed remedy, which is a second hydrogenation step at the salt level.

[00:37:35] Speaker 05:
What's claimed here is a product having a low level of 14-hydroxy.

[00:37:39] Speaker 03:
So we can do a de novo analysis and apply idle process to the extent it is even applicable here.

[00:37:45] Speaker 05:
I believe that's the case, Your Honor.

[00:37:49] Speaker 05:
So, and getting back again, it's the same, my colleague was referencing page 19 in Purdue's opening brief, and again, talking about this is the process that they allegedly invented, but they haven't claimed this process.

[00:38:10] Speaker 05:
There is no claim that's directed to having a salting plus hydrogenation too.

[00:38:23] Speaker 05:
And as the district court found, the prior art taught that 14-hydroxy in its base or salt form could be converted to oxycodone through hydrogenation, and that you could continue that hydrogenation until the 14-hydroxy essentially disappears.

[00:38:40] Speaker 05:
And Chu in particular discusses this, especially if you refer to example six, where he taught using hydrogenation as a purification step.

[00:38:48] Speaker 05:
And he said, take the 14-hydroxy, hydrogenate,

[00:38:52] Speaker 05:
Check to see if the 14-hydroxy has disappeared, and if it hasn't, hydrogenate some more.

[00:38:58] Speaker 05:
The other thing that's pertinent here is that although the Purdue inventors have characterized this reappearance of 14-hydroxy as a result of 8-alpha sphere problem requiring the second hydrogenation step, it's not the process that's used to make the API that's used by TEHA and AMUEL.

[00:39:22] Speaker 05:
That is actually made without a second hydrogenation step at the salt level.

[00:39:26] Speaker 05:
There is no hydrogenation of the salt.

[00:39:29] Speaker 05:
In our AMCO process... And where does that leave us?

[00:39:31] Speaker 06:
Because this isn't an infringement question.

[00:39:33] Speaker 06:
This is where we're here on validity.

[00:39:35] Speaker 06:
That's exactly right.

[00:39:37] Speaker 05:
So it leaves us at the point where they're now trying to argue a theory of validity that would have eliminated their infringement position.

[00:39:45] Speaker 05:
They prevailed on the infringement at trial, and now they're changing their tact, and they're saying, suddenly, our invention, although they did some of this at trial as well, our invention is actually in the second hydrogenation step, which is something they did not have to prove as an element of infringement.

[00:39:59] Speaker 05:
And now they're arguing that that is a patentable distinction over the prior art.

[00:40:09] Speaker 05:
Two, discuss hydrogenating oxytocin on base,

[00:40:12] Speaker 05:
Ramazan taught converting 14-hydroxy into its hydrochloride salt, and then hydrogenating with hydrochloride salt.

[00:40:20] Speaker 05:
So as the district court found, in a very thorough opinion, flying all the brand factors, the claims to a product having a low level of 14-hydroxy were obvious, particularly when people in the industry were motivated by the FDA saying, get your 14-hydroxy levels down, they were motivated to do it.

[00:40:43] Speaker 05:
If I can touch just briefly on the collateral estoppel issue.

[00:40:48] Speaker 05:
What that means is that obviously if the merit of the decision is affirmed below, there should be no dispute that collateral estoppel was properly applied.

[00:40:56] Speaker 05:
Purdue admitted that all elements of collateral estoppel were satisfied.

[00:41:01] Speaker 05:
When the district court ordered Purdue to show cause as to why collateral estoppel should not be applied and admitted that it should.

[00:41:08] Speaker 05:
So the result that flows from this is that

[00:41:12] Speaker 05:
If either the appeal of the decision on the merits has been mooted by the settlement agreement, or if the decision is affirmed on the merits, then there should be no dispute that collateral estoppel applies.

[00:41:26] Speaker 06:
Can I just clarification, and I know we don't want to get into some.

[00:41:29] Speaker 06:
This is a separate question.

[00:41:30] Speaker 06:
Sure.

[00:41:31] Speaker 06:
If the appeal is mooted by the settlement agreement, what we have before us that's left are the JMAAL estoppel question.

[00:41:42] Speaker 06:
on the STAPL.

[00:41:44] Speaker 06:
It's my understanding that the narrow area of our review wouldn't be to review the merits of those determinations, but simply to review whether or not a STAPL was correctly applied.

[00:41:55] Speaker 06:
Is that your position?

[00:41:56] Speaker 06:
That's correct.

[00:41:57] Speaker 06:
We would not be able to reach the merits in those circumstances.

[00:42:01] Speaker 05:
That's correct.

[00:42:01] Speaker 05:
The analysis would be whether or not collateral STAPL was properly applied, but when you're

[00:42:06] Speaker 05:
undertaking that determination, you do not look at whether the underlying decision was correct.

[00:42:13] Speaker 05:
If it's a final and binding judgment and all the elements of collateral estoppel were satisfied, for example, if there was a full and fair opportunity to litigate, which is usually the big one, then collateral estoppel should be affirmed without looking at the merits of correctness.

[00:42:29] Speaker 03:
You just addressed commercial success for a moment.

[00:42:32] Speaker 03:
The district court seemed to put great weight on the lack of evidence that the low level of 14-hydroxy was ever marketed as a basis to purchase the product.

[00:42:44] Speaker 03:
Isn't that too narrow a view of commercial success and what might support it?

[00:42:49] Speaker 05:
I think it was only one element of what the court considered in the context of commercial success.

[00:42:54] Speaker 05:
I think it also considered that there were other factors that actually drove sales both up and down of oxycodone.

[00:43:00] Speaker 05:
and also looked at the commercial success that Purdue alleges is that of its supplier, because it's the supplier that makes the API having a low A buck.

[00:43:10] Speaker 05:
When they tried to sell that to somebody other than their corporate affiliates, they were not able to sell it.

[00:43:16] Speaker 05:
I think the district court looked at more than just that it wasn't advertised as being a low A buck OxyCone.

[00:43:25] Speaker 05:
It looked also at the fact that there were actually other facts that drove sales up and down.

[00:43:29] Speaker 03:
Why should the supplier success not factor into a commercial success analysis?

[00:43:35] Speaker 05:
It may be that there are circumstances where it would, except that here there wasn't commercial success of the supplier.

[00:43:43] Speaker 05:
The success of the supplier was due to the fact that Purdue invested a boatload of money into setting them up as Purdue's supplier, because they thought that it would give them a cheaper and more

[00:43:57] Speaker 05:
dependable source of their API, as opposed to ... In fact, they made that investment before Rhodes actually started making the low ABUC API.

[00:44:10] Speaker 05:
The only person that Rhodes has ever really sold to is his corporate affiliate.

[00:44:16] Speaker 05:
When it tried to sell to anybody else, it didn't have success in doing so.

[00:44:23] Speaker 05:
So I have just a few seconds remaining.

[00:44:28] Speaker 05:
So again, really, annual is here because of the collateral estoppel issue.

[00:44:32] Speaker 05:
For good reason, the obvious misdetermination should be affirmed on the merit if it has not been mooted by whatever's in the settlement agreement.

[00:44:41] Speaker 05:
The district court gave a very thorough opinion that applied grant, looked at the scope and content of the prior

[00:44:49] Speaker 05:
that everything that he was supposed to do, he clearly had, Judge Stein clearly had a great grasp of the technical nature of his case.

[00:44:55] Speaker 05:
There had been no claims by Purdue, either at the district court level or here, that it did not have a full and fair opportunity to litigate its case.

[00:45:04] Speaker 05:
In fact, it had two trials to do so.

[00:45:07] Speaker 05:
So the collateral self-judgment should be affirmed.

[00:45:09] Speaker 05:
Thank you.

[00:45:10] Speaker 05:
Thank you, Your Honor.

[00:45:28] Speaker 02:
I'll take the issues on rebuttal in the order that my friends address them.

[00:45:33] Speaker 02:
Start with 383.

[00:45:35] Speaker 02:
With regard to anticipation, my friend Mr. Schuman refers to extrinsic evidence outside the four corners of the patent.

[00:45:44] Speaker 02:
That doesn't tell us what the words such as these three drugs and the like means.

[00:45:50] Speaker 02:
This court's Finistar decision says ordinary rules of grammar apply with regard to anticipating references.

[00:45:55] Speaker 02:
Ordinary rules of grammar, of which a Eustem generis is a classic one, tell us that aspirin, Tylenol, and another NSAID are not and the like of oxycodone, opioids, or opiates.

[00:46:08] Speaker 02:
And I'd also point out that claymate is specific to oxycodone.

[00:46:13] Speaker 02:
With regard to obviousness, the fact that McGinnity was the part of a lawsuit

[00:46:17] Speaker 02:
Another lawsuit is a really just misleading fact here, because what a patent claims versus what it describes and discloses are two entirely different questions.

[00:46:30] Speaker 02:
It may very well infringe, but it may not describe.

[00:46:34] Speaker 02:
And that's what we have here as a patent that doesn't describe.

[00:46:37] Speaker 02:
Concerta, it was said to be a straw man.

[00:46:39] Speaker 02:
Well, it was a straw man that our friends on the other side opened up a trial.

[00:46:43] Speaker 02:
Concerned, by the way, was said by Judge Stein to have a PEO outer shell.

[00:46:49] Speaker 02:
That is absolutely, clearly, and demonstrably erroneous.

[00:46:53] Speaker 02:
The outer shell was made of cellulose acetate, A87095, also A2470-75, and Rudenthal's reply brief at page 23 support that.

[00:47:08] Speaker 02:
And with regard to the 383 patent, secondary considerations, Judge Stark, you mentioned that with regard to low ABUS, but with regard to 383, they're really powerful when you take this outside of the anticipation context where it doesn't belong and into the obviousness context.

[00:47:22] Speaker 02:
This changed the entire marketplace.

[00:47:24] Speaker 02:
This changed FDA.

[00:47:25] Speaker 02:
It changed the FDA's calculus of safety, and it saved lives.

[00:47:30] Speaker 02:
It made Oxycodone safer.

[00:47:32] Speaker 02:
Abuse, as the amicus brief on abuse has pointed out, has dropped significantly since the introduction of this into the marketplace.

[00:47:41] Speaker 02:
And if that regulatory success combined with the later success in the marketplace isn't an appropriate secondary consideration, I'm not sure what is or should be.

[00:47:51] Speaker 02:
With regard to low A-Bucks,

[00:47:52] Speaker 02:
My friend on the other side said that it was raised very briefly.

[00:47:56] Speaker 02:
Well, that's also just not true.

[00:47:59] Speaker 02:
We raised it repeatedly, and we put that in our brief.

[00:48:02] Speaker 02:
That's in our opening argument, A39-34-40, A49-14.16 in our pretrial memo, A53-59 in our proposed findings before trial, A73-15 proposed findings and conclusions after trial.

[00:48:16] Speaker 02:
It was all over the place.

[00:48:17] Speaker 02:
The judge didn't deal with it, and our opponents, by the way, never deal with the court's more recent decision of Leo Pharmaceuticals.

[00:48:23] Speaker 02:
With regard to the substance of the IBLE rule, my friend says that it's required to say that you have to patent the remedy.

[00:48:30] Speaker 02:
You can search all the IBLE process cases that we've cited to you, and you will search in vain for that rule.

[00:48:36] Speaker 02:
The rule out of IBLE is the discovery of a non-obvious problem and the application of a solution to it is patentable invention.

[00:48:46] Speaker 02:
Idle didn't say gravity in his claims, but that was what the solution was to his claims.

[00:48:52] Speaker 02:
Judge Stark, you're absolutely right with regard to the district court's too narrow focus on commercial success.

[00:48:58] Speaker 02:
Rhodes' commercial success was the difference between night and day, between viability and nonviability.

[00:49:04] Speaker 02:
Finally, although I have to be careful, both of my friends have brought up the questions of mootness.

[00:49:11] Speaker 02:
And let me just respond to that by saying the following.

[00:49:16] Speaker 02:
In the documents, which you've been urged to read, and which I'm sure the court will, you will see numerous references to this case, the low A buck dispute.

[00:49:28] Speaker 02:
and in anticipation that this dispute will continue.

[00:49:31] Speaker 02:
In fact, there is a remand appeal result that is specifically anticipated in the section 4D.

[00:49:38] Speaker 02:
I think I can say that much in open court.

[00:49:40] Speaker 02:
Section 4D of the settlement agreement talks about the consequences of a remand appeal result.

[00:49:46] Speaker 02:
Releases were granted on other patents, but not these.

[00:49:48] Speaker 02:
There was no consent judgment with regard to the low A-buck appeal.

[00:49:52] Speaker 02:
And ultimately, aside from all of the textual indicators that that's what the parties intended,

[00:49:57] Speaker 02:
As we've said in our papers, there is still a real live dispute.

[00:50:01] Speaker 02:
The dispute has obviously been joined here.

[00:50:04] Speaker 02:
So this is not abstract.

[00:50:05] Speaker 02:
It's not a side bet.

[00:50:07] Speaker 02:
And after, what are the consequences of a decision?

[00:50:10] Speaker 02:
I realize we're in an Article III court with limited power, but what are the consequences of a decision on the low ABUC path?

[00:50:16] Speaker 02:
The consequences are at least two.

[00:50:18] Speaker 02:
One of which is, it will prevent our friends

[00:50:22] Speaker 02:
from accelerating what is called the terminal page.

[00:50:25] Speaker 02:
And I think I can say that without going into detail about what it means.

[00:50:29] Speaker 06:
The last point on that

[00:50:37] Speaker 02:
is that under all the circumstances, particularly all the clear indicators of intent, if the court were to, despite those fines, this dispute would, it should nonetheless order vacatur of these judgments in favor of Teve so that this case could be litigated by the other parties.

[00:50:54] Speaker 06:
Thank you.

[00:50:54] Speaker 06:
Thank you.

[00:50:54] Speaker 06:
We thank all parties, and the case is submitted.