[00:00:00] Speaker 01:
We have four argued cases today.

[00:00:03] Speaker 01:
The first is number 18, 1285, Purdue Pharma LP versus Yanku.

[00:00:10] Speaker 01:
Mrs. Slise, is that how you pronounce it?

[00:00:14] Speaker 02:
Good morning, Your Honor.

[00:00:14] Speaker 01:
It's actually Sweezy.

[00:00:16] Speaker 01:
Sweezy, okay.

[00:00:16] Speaker 02:
I tried.

[00:00:17] Speaker 02:
It's not the way it looks.

[00:00:19] Speaker 02:
So I would not expect that.

[00:00:23] Speaker 02:
Good morning, Your Honors.

[00:00:24] Speaker 02:
May it please the court, Jennifer Sweezy, on behalf of Purdue, the patent owners and appellants in these IPRs.

[00:00:32] Speaker 02:
The board and these IPRs make two fundamental errors that I would like to focus on this morning.

[00:00:37] Speaker 00:
But before you get into the merits of your argument, I have a couple of very quick questions by way of background.

[00:00:45] Speaker 00:
The first question is, the version of OxyContin that is commercialized now, does that practice this patent?

[00:00:54] Speaker 02:
Yes, it does.

[00:00:55] Speaker 00:
So that's a product that is prepared with heating the magnesium stearate with the core matrix?

[00:01:04] Speaker 02:
Yes.

[00:01:05] Speaker 00:
And would you say that a product that does not heat the magnesium stearate with the core matrix would not infringe?

[00:01:17] Speaker 02:
Yes, Your Honor.

[00:01:17] Speaker 02:
Under the proper construction of the claim,

[00:01:21] Speaker 02:
All three components, and that's the first issue I do want to talk about, is clang construction.

[00:01:25] Speaker 02:
All three components have to be together for the core matrix to be heated.

[00:01:29] Speaker 00:
So if somebody produced a product that did not heat the magnesium stearate with the core matrix, you would have no infringement case?

[00:01:39] Speaker 02:
That's right.

[00:01:39] Speaker 02:
It's certainly under the broadest reasonable interpretation, which applies in these proceedings.

[00:01:43] Speaker 01:
OK.

[00:01:43] Speaker 01:
So what does the record reflect about the benefits of heating the magnesium stearate as part of the matrix?

[00:01:51] Speaker 02:
The record shows that no one would have thought to do this.

[00:01:56] Speaker 01:
No, I'm talking about it in terms of the patented invention.

[00:02:00] Speaker 01:
You say the patented invention requires this.

[00:02:03] Speaker 01:
What does the patent say that the benefits of heating the magnesium stearate are?

[00:02:10] Speaker 02:
Yes, Your Honor, the benefit is an abuse deterrent formulation.

[00:02:14] Speaker 02:
that uses these particular ingredients.

[00:02:17] Speaker 01:
That doesn't really answer my question.

[00:02:19] Speaker 01:
My specific question is, what does the patent say?

[00:02:23] Speaker 01:
Or what does the record say about the benefits of heating the magnesium stearate?

[00:02:30] Speaker 02:
The patent, by claiming these abuse deterrent formulations, reflects that the process of heating, which of course changes the chemical formulation, by doing the heating to all three of these does impart

[00:02:44] Speaker 02:
and abuse deterrent formulation as reflected in our product.

[00:02:48] Speaker 01:
What is the benefit, according to the patent, of heating the magnesium stearate as opposed to making the formulation?

[00:02:55] Speaker 01:
As I understand it, magnesium stearate is a lubricant that helps you make the tablets.

[00:03:01] Speaker 01:
What's the benefit of heating it?

[00:03:03] Speaker 02:
The benefit of heating it is that it pulls all of these ingredients together

[00:03:07] Speaker 02:
in such a way that they cannot be pulled apart by an abuser.

[00:03:11] Speaker 02:
So they wouldn't be able to extract solely the active ingredient, the oxycodone, the active ingredient.

[00:03:18] Speaker 02:
The abusing of these ingredients.

[00:03:20] Speaker 01:
Well, that's the benefit of mixing them together.

[00:03:21] Speaker 01:
But where does it say there's a benefit to heating?

[00:03:25] Speaker 02:
The benefit to heating, the claims require that.

[00:03:27] Speaker 02:
And as a chemical matter, and I'm not sure that I can explain this myself, but the process of heating those three components together creates

[00:03:36] Speaker 02:
The kind of matrix, the kind of.

[00:03:38] Speaker 01:
OK, well, did your expert or did one of the experts say that there's a benefit to heating the magnesium steroid?

[00:03:44] Speaker 02:
I believe so, Your Honor.

[00:03:45] Speaker 02:
I can check and address that.

[00:03:48] Speaker 01:
Where do we find that?

[00:03:50] Speaker 02:
I can see if we can, let me see if I can locate that for you.

[00:03:53] Speaker 02:
It wasn't an issue on appeal, so I don't think it's relevant to the construction of the claims, because of course the claims to find.

[00:04:00] Speaker 01:
Well, maybe it is, because also I don't see that the patent specification really discloses

[00:04:07] Speaker 01:
Aside from your interpretation of the claim language itself, I don't think the specification discloses an embodiment in which the magnesium stearate is heated.

[00:04:16] Speaker 01:
In fact, the example six discloses adding it after the heating is completed.

[00:04:25] Speaker 00:
In fact, I think all the examples that include magnesium stearate show magnesium stearate being added after the cooling, isn't that right?

[00:04:34] Speaker 02:
That's true.

[00:04:34] Speaker 02:
And we don't dispute that.

[00:04:35] Speaker 02:
But of course, a patent doesn't have to practice every claim.

[00:04:40] Speaker 02:
And examples are just examples.

[00:04:42] Speaker 00:
They don't define the claims.

[00:04:43] Speaker 00:
Right.

[00:04:43] Speaker 00:
But if the patent is, if your position is that what's really distinctive about this patent and what's really important to its efficacy is that the magnesium stearate is heated with the core matrix, then it's hard to square that with the fact that every single example that uses magnesium stearate

[00:05:04] Speaker 00:
has the magnesium stearate cool after cooling?

[00:05:08] Speaker 02:
So a couple of responses to that.

[00:05:10] Speaker 02:
First, our specification does disclose this embodiment.

[00:05:14] Speaker 02:
It's not in an example, but it is disclosed in the specification.

[00:05:16] Speaker 00:
This is column 17?

[00:05:17] Speaker 02:
Yes.

[00:05:18] Speaker 00:
Well, OK.

[00:05:20] Speaker 02:
It does disclose the embodiment.

[00:05:22] Speaker 02:
And of course, examples do not limit the claims.

[00:05:27] Speaker 02:
The claim couldn't be any clearer.

[00:05:28] Speaker 01:
The way it only discloses the example is this in column 17, line 8.

[00:05:35] Speaker 01:
The homogeneous mixture is then heated to a temperature sufficient, but that's what you say discloses it?

[00:05:41] Speaker 02:
Yes, Your Honor, because that passage in column 17 talks about combining an opioid, analgesic, and an aversive agent, which has been previously defined to include PEO.

[00:05:53] Speaker 02:
And then in that same column at lines 37 through 42, we say that other pharmaceutical incipients, such as a lubricant, which has been

[00:06:04] Speaker 02:
defined to include magnesium stearate can be included in that matrix formulation.

[00:06:11] Speaker 00:
But it doesn't refer there to the timing of the heating, as I read it.

[00:06:17] Speaker 02:
The prior passage talks about a heated composition.

[00:06:23] Speaker 00:
But at that point, you aren't talking about the inclusion of magnesium stearate, right?

[00:06:29] Speaker 00:
Your argument is that there's a reference at the top of column 17

[00:06:34] Speaker 00:
to heating, and there's a reference in the middle of 17 to adding the magnesium stearate.

[00:06:40] Speaker 00:
I don't see where this column reflects, or at least clearly reflects, that the magnesium stearate is in fact heated.

[00:06:48] Speaker 02:
It does, Your Honor, because at the beginning of 17, it says we're talking about the preparation of a suitable melt extruded matrix.

[00:06:56] Speaker 02:
And that's the first sentence of the first full paragraph in column 17.

[00:07:02] Speaker 02:
And it says it may include the opioid,

[00:07:04] Speaker 02:
and an aversive agent.

[00:07:05] Speaker 02:
And then further down in column 17, it refers specifically to the sustained released matrices of the present invention, which is a reference and certainly discloses that magnesium stearate can be included.

[00:07:19] Speaker 02:
And of course, there's the claim language itself, which is for claim construction, the starting point.

[00:07:24] Speaker 02:
So if I can address that issue as well as what the board

[00:07:28] Speaker 02:
mistakenly read for its improper construction.

[00:07:32] Speaker 01:
Do you have a reference to us about the benefits of heating the magnesium stearate?

[00:07:37] Speaker 02:
I will see if I can locate that for rebuttal, your honor.

[00:07:39] Speaker 02:
I apologize for not having that right now.

[00:07:42] Speaker 02:
But what I can tell you is that nobody thought to do that.

[00:07:46] Speaker 02:
And we don't necessarily have to explain in a patent all the whys, but we do have to provide, the patent has to claim something that is novel and non-obvious.

[00:07:56] Speaker 01:
Well, maybe in terms of interpreting the patent,

[00:07:58] Speaker 01:
If there's no benefit to it, then maybe you're less likely to interpret it as being required.

[00:08:08] Speaker 02:
Respectfully, Your Honor, those are, I believe, conflating different issues.

[00:08:12] Speaker 02:
Of course, 112 issues are not at play in an inter-party's review.

[00:08:15] Speaker 02:
And we do believe that the claim construction itself, along with consistent agreement throughout these proceedings, supports our construction.

[00:08:23] Speaker 02:
This wasn't debated.

[00:08:24] Speaker 02:
It wasn't a dispute that the core matrix has to include these three ingredients, and then that core matrix has to be heated.

[00:08:32] Speaker 02:
That wasn't a dispute.

[00:08:34] Speaker 02:
And I'd like to take the court specifically to the party's stipulation, because that is where the board got off on the wrong foot on this issue.

[00:08:41] Speaker 00:
You're talking about the email from August 10th, 2017?

[00:08:45] Speaker 00:
Yes, your honor.

[00:08:46] Speaker 02:
Appendix 8938.

[00:08:48] Speaker 02:
And the parties were asked by the board

[00:08:54] Speaker 02:
put in writing an agreement that they made clear at the oral hearing that this is what the claim means.

[00:09:00] Speaker 02:
Again, they weren't even disputing the whys or the benefits, but simply looking at the plain language and given the consistent testimony from the experts about what this claim means, they agreed to that before the board at the oral hearing, and then they put this in writing at the stipulation.

[00:09:16] Speaker 02:
The board misread the stipulation.

[00:09:18] Speaker 02:
The stipulation hinges, and I can make four brief points.

[00:09:21] Speaker 02:
It hinges on the term the core matrix.

[00:09:24] Speaker 02:
which the parties defined as a blended mixture having three ingredients.

[00:09:27] Speaker 02:
That's the second full paragraph.

[00:09:30] Speaker 02:
In the third full paragraph, they then use that term, this is my second point, they define heating the core matrix as necessarily predicated on what the core matrix is, those three ingredients combined.

[00:09:44] Speaker 02:
There is a final sentence, this is my third point, that the board read as eviscerating those two prior agreed upon statements.

[00:09:51] Speaker 02:
In the final sentence, the board says,

[00:09:55] Speaker 02:
that it doesn't mean heating the core matrix, but you can heat just one ingredient.

[00:10:00] Speaker 02:
That's how they read this.

[00:10:01] Speaker 02:
But that is not what that final sentence says.

[00:10:03] Speaker 00:
The final sentence being the one that starts heating occurs at any time during the preparation?

[00:10:08] Speaker 00:
Yes, Your Honor.

[00:10:09] Speaker 02:
That final sentence is simply talking about when heating can occur once you have the three blended ingredients together.

[00:10:18] Speaker 02:
It cannot be read in isolation from the two

[00:10:20] Speaker 02:
prior agreed upon statements that, one, the core matrix is these three ingredients, because in that paragraph they use and all three ingredients define the core matrix.

[00:10:30] Speaker 02:
And then in the second paragraph, the core matrix is heating that blended mixture, which they again define as those three ingredients.

[00:10:39] Speaker 00:
And perhaps this is reading with too much of a jeweler's eye, a sentence that was perhaps not crafted terribly well.

[00:10:48] Speaker 00:
If your position is correct, why wouldn't that sentence have simply said heating incurs at any time after preparation of the blended mixture?

[00:10:57] Speaker 00:
It's the during that causes you a problem, it seems to me, because during the preparation, the mixture could reasonably encompass, it would seem to me, before you've added all of the components of the mixture.

[00:11:11] Speaker 00:
Isn't that right?

[00:11:12] Speaker 02:
No, Your Honor, let me give you a few reasons.

[00:11:14] Speaker 02:
First, because it can't be read in isolation from these two prior agreements that you have those three ingredients.

[00:11:20] Speaker 02:
A core matrix doesn't exist unless you have all three of those ingredients together.

[00:11:24] Speaker 02:
What that passage is doing is recognizing under the broadest reasonable interpretation, we weren't going to be so draconian as to say you're going to entirely blend the mixture without any heating whatsoever, and that all heating is entirely thereafter.

[00:11:40] Speaker 02:
We recognized, frankly, a very sort of perhaps metaphysical minor situation where you might be blending and heating at the same time.

[00:11:49] Speaker 02:
And so it's simultaneously blending.

[00:11:51] Speaker 02:
You have the blended mixture.

[00:11:52] Speaker 02:
You're also heating.

[00:11:53] Speaker 02:
You're therefore heating the blended mixture.

[00:11:56] Speaker 02:
But you cannot read that sentence, particularly in light of the two prior agreements and the consistent testimony by the experts in this case and the claim language as somehow now allowing heat to be applied to only one ingredient.

[00:12:10] Speaker 01:
Before we run out of time, there are other questions on this point.

[00:12:15] Speaker 01:
Let me ask you to talk about McGinnity.

[00:12:18] Speaker 02:
Yes.

[00:12:19] Speaker 01:
And why it's not appropriate to interpret McGinnity as allowing the heating of magnesium stearate as part of the process disclosed there.

[00:12:37] Speaker 02:
Your Honor, our best evidence on that is Dr. Timco Amniel's expert, who clearly said that McGinnity, Palermo, and no other reference would teach.

[00:12:46] Speaker 02:
And this brings me back to the conversation we were having at the beginning, that nobody thought to do this.

[00:12:52] Speaker 02:
Nobody thought to add magnesium stearate.

[00:12:54] Speaker 01:
Well, that's a sort of a generalized statement.

[00:12:56] Speaker 01:
But there's specific language in McGinnity which seems to say that lubricant can be included

[00:13:07] Speaker 01:
in what's heated as long as it's not inconsistent with the process or some language like that.

[00:13:14] Speaker 01:
Where do we find McGinnity in here?

[00:13:16] Speaker 01:
What is the page number?

[00:13:17] Speaker 02:
In appendix 4830 through 4835, I can read the court two specific passages in paragraph 44.

[00:13:27] Speaker 02:
This is 4830.

[00:13:29] Speaker 02:
This is Dr. Timco's report.

[00:13:31] Speaker 01:
I was asking you where McGinnity was.

[00:13:33] Speaker 02:
Oh, I'm sorry, Your Honor.

[00:13:34] Speaker 02:
The guinity is at, and the passage the court is referring to is on page 13, which is at appendix 512.

[00:13:42] Speaker 02:
The problem here is that the board took its own exercise of evaluating the guinity, which of course is not from the perspective of a person of ordinary skill in the art, and was contrary to the evidence in this case.

[00:13:55] Speaker 01:
And this court has been clear that- Well, they have expertise in interpreting

[00:14:00] Speaker 01:
Where is this?

[00:14:02] Speaker 01:
McGinnity is 478, 479.

[00:14:05] Speaker 02:
I have it at 512.

[00:14:09] Speaker 01:
Yeah, it's at the top of page 480, right?

[00:14:12] Speaker 01:
In addition to the above ingredients, a sustained release matrix incorporating melt-excluded multi-particulates may also include suitable quantities of other materials, e.g.

[00:14:22] Speaker 01:
hit-less lubricants, right?

[00:14:25] Speaker 01:
So did your expert address that language in McGinnity?

[00:14:30] Speaker 02:
Yes, our expert and Anmuel's expert both said you couldn't read.

[00:14:34] Speaker 02:
The priorit wouldn't teach this.

[00:14:35] Speaker 01:
Now, my question is, did they address that language in particular?

[00:14:41] Speaker 02:
So, Your Honor, I think we might be looking at different.

[00:14:49] Speaker 01:
It's a top of 480.

[00:14:50] Speaker 01:
480.

[00:14:53] Speaker 01:
The first paragraph.

[00:14:59] Speaker 02:
Yes, Your Honor.

[00:15:00] Speaker 02:
So the experts looked at McGinnity.

[00:15:04] Speaker 01:
And Dr. Timko said... My question is very specific.

[00:15:07] Speaker 01:
Did either of the experts address that language and tell us how that language should be interpreted?

[00:15:15] Speaker 02:
They addressed McGinnity as a whole.

[00:15:17] Speaker 02:
Not that language.

[00:15:20] Speaker 02:
I don't know that... I think that their conclusion was that nothing in McGinnity

[00:15:27] Speaker 02:
Because nothing in the prior art, and I see my time is out, Your Honor.

[00:15:29] Speaker 02:
But to answer this question, they did not find anything in McGinnity.

[00:15:33] Speaker 02:
And that can be found at paragraphs 44 and 4835 of the appendix.

[00:15:38] Speaker 02:
Nothing in the prior art thought about using or would have thought to use magnesium steroid in a hot melt extrusion because of the significant concerns and problems, the unworkability of that formulation.

[00:15:50] Speaker 01:
What do you mean the unworkability?

[00:15:53] Speaker 02:
that magnesium steroid has incompatibilities with oxycodone and with heat.

[00:15:58] Speaker 02:
And combining all of those together, nobody in the art thought that that would be.

[00:16:02] Speaker 01:
Where do they say that it's incompatible with heating?

[00:16:07] Speaker 02:
As simple as the handbook for pharmaceutical excipients says that.

[00:16:11] Speaker 02:
Our experts relied on that.

[00:16:13] Speaker 01:
But I'm asking you where.

[00:16:15] Speaker 01:
Where do I find the testimony or the excerpt from the handbook saying that

[00:16:22] Speaker 01:
You can't heat the magnesium lubricant.

[00:16:24] Speaker 02:
Your honor, that is at, the handbook itself is at appendix 4661.

[00:16:29] Speaker 02:
4661?

[00:16:32] Speaker 02:
Yes, there are other references at 4669.

[00:16:34] Speaker 01:
Well, wait, wait.

[00:16:37] Speaker 01:
Okay, 4661.

[00:16:42] Speaker 01:
Okay, so where does it say this?

[00:16:43] Speaker 02:
It specifically says, it has a section describing magnesium stearate that it is in

[00:16:48] Speaker 02:
Compatible with oxycodone and talks about the okay, but that's not what we're talking about We're talking about heating it talks about on page 4 6 6 1 in section 19 comments that magnesium stearate is sensitive to mixing time and that blended this is the final sentence on page appendix 4 6 6 1 blending times with magnesium stearate should be Carefully yeah, but that's not my question.

[00:17:14] Speaker 01:
My question is where does it say you shouldn't heat it?

[00:17:18] Speaker 02:
That is expressly said by both experts in this case.

[00:17:22] Speaker 01:
Where?

[00:17:23] Speaker 01:
Just give me one example.

[00:17:25] Speaker 02:
Dr. Timko, 4829.

[00:17:27] Speaker 01:
4829?

[00:17:29] Speaker 02:
Yes.

[00:17:30] Speaker 01:
OK.

[00:17:30] Speaker 02:
Through 4835.

[00:17:32] Speaker 01:
OK, where does he say you shouldn't heat it?

[00:17:38] Speaker 02:
In paragraph 42 on 4829, about halfway down, he says, the Senate's starting nothing.

[00:17:47] Speaker 02:
Nothing in McGinnity suggests adding the magnesium stearate to the HME, which is the hot melt extrusion process used by McGinnity.

[00:17:55] Speaker 02:
And he says, two sentences later, and knowing what a person of ordinary skill in the art would know about the decades-old handling issues of magnesium stearate, no other interpretation of McGinnity is justified.

[00:18:09] Speaker 01:
Where does he say it shouldn't be heated?

[00:18:12] Speaker 02:
That's what he's saying in this paragraph.

[00:18:14] Speaker 02:
The hot melt extrusion is the heating process in McGinnity.

[00:18:18] Speaker 02:
And he is saying that nothing in McGinnity taught in a person of ordinary skill in the art would not think or would want to add magnesium stearate to that hot melt extrusion process.

[00:18:29] Speaker 02:
He again says similarly in paragraph 43, a person of ordinary skill in the art would have had no reason to try to include magnesium stearate in the core of a hot melt

[00:18:41] Speaker 02:
Extrusion formulation he's quoting us, and he says on the next page that is absolutely true There is no reason to include magnesium stearate and the hot milk extrusion, okay?

[00:18:52] Speaker 02:
That's different from saying it would be harmful to do it And I don't believe harmful is the test your honor the obvious in his inquiry is whether a person of ordinary skill in the art would have been motivated to combine these ingredients in the manner claimed and

[00:19:08] Speaker 02:
And Dr. Timko, Amule's expert, is expressly agreeing that when the claim is properly construed as requiring the heat applied to the core matrix, all three ingredients, no person of ordinary skill in the art would have thought to do that.

[00:19:24] Speaker 01:
Anything else?

[00:19:24] Speaker 01:
OK, we'll give you two minutes for a follow-up.

[00:19:26] Speaker 02:
Thank you.

[00:19:26] Speaker 02:
I appreciate that.

[00:19:34] Speaker 01:
Ms.

[00:19:34] Speaker 01:
Craven?

[00:19:42] Speaker 03:
Good morning, Your Honor.

[00:19:42] Speaker 03:
May it please the court?

[00:19:44] Speaker 03:
McGinnity and Palermo teach adding magnesium steroid to a dosage form in the identical manner as a 976 patent.

[00:19:53] Speaker 03:
It's an additional component that can be added to a hot melt extruded dosage form.

[00:19:57] Speaker 03:
Therefore, the board didn't err in finding the claims obvious under either of the claim constructions.

[00:20:03] Speaker 03:
So the board construed the core matrix is heated based on the stipulation, which is similar to statements in the prosecution history,

[00:20:11] Speaker 03:
And importantly, in light of the specification, it found that there's no disclosure that during preparation of the core matrix necessarily had heating of the magnesium stearate as part of that core matrix.

[00:20:25] Speaker 01:
Everywhere there's... Is there any place in the patent or in the expert testimony that says there's a benefit to heating the magnesium stearate?

[00:20:33] Speaker 03:
I do not recall any statements like that.

[00:20:36] Speaker 03:
I think both experts did say that one of skill in the art would understand that you would

[00:20:41] Speaker 03:
tried to avoid heating magnesium stearate in a hot melt extrusion.

[00:20:45] Speaker 03:
That was the testimony from both of the experts.

[00:20:48] Speaker 01:
And I think that what's important, though, is... Well, I'm not sure that the... I was just asking about that.

[00:20:54] Speaker 01:
Is there such testimony that you avoid heating it hot?

[00:20:57] Speaker 01:
Where is that?

[00:20:58] Speaker 03:
I don't know if I can point you to something that says avoid heating, but I think they were saying that an expert... one of skill in the art reading McGinnity

[00:21:06] Speaker 03:
wouldn't see any benefits to it.

[00:21:08] Speaker 03:
I didn't say anything about benefits, but that they would avoid too much heating and too much shearing with the magnesium steroid.

[00:21:18] Speaker 01:
I didn't see that testimony.

[00:21:20] Speaker 03:
That was my understanding, generally, of the testimony.

[00:21:23] Speaker 03:
I'm not sure I could point you to a particular place that says that.

[00:21:27] Speaker 03:
But I think what's important is that the disclosure

[00:21:31] Speaker 03:
in the 976 patent doesn't say that there's any way to overcome any of these problems that they said about heating the magnesium stearate.

[00:21:38] Speaker 03:
They seem to suggest that they have invented this core matrix in heating magnesium stearate.

[00:21:44] Speaker 03:
But the disclosure that they have in the 976 patent does not differ in any way from McGinnity's, which also teaches adding oxycodone and PEO hot melt extrusion and says you can add other components like a lubricant magnesium stearate.

[00:22:00] Speaker 03:
And Palermo has the identical disclosure almost word for word.

[00:22:03] Speaker 03:
It's one of Purdue's earlier patents where it suggests making an extended release oxycodone dosage form.

[00:22:10] Speaker 03:
You can add other components to the sustained matrix and one of those would be a lubricant magnesium stearate.

[00:22:18] Speaker 03:
Specifically in the 976 patent, they pointed to magnesium stearate as a lubricant for tableting.

[00:22:24] Speaker 03:
And that's something that suggests the end of the process so that the heating occurred during the formation of the core matrix.

[00:22:31] Speaker 03:
The magnesium stereate was then blended and then tabulated.

[00:22:34] Speaker 00:
Blended after cooling?

[00:22:36] Speaker 03:
At some point after the extrusion process.

[00:22:39] Speaker 03:
So I don't know if it's cool, all cool, some level of heat.

[00:22:42] Speaker 03:
There's no testimony one way or the other, and I'm not sure.

[00:22:45] Speaker 00:
No, I'm thinking about the examples.

[00:22:47] Speaker 00:
I think all of the examples that have magnesium stereates specifically call out

[00:22:53] Speaker 00:
This is after the cooling process.

[00:22:56] Speaker 03:
That's true.

[00:22:57] Speaker 03:
I think all the examples do have that cooling step.

[00:23:01] Speaker 03:
I think it's melt granulation that the examples use.

[00:23:05] Speaker 03:
They mix the OxyCo or the active ingredient in the aversive agent, like a PEO, and then cool it and add the magnesium stearate.

[00:23:13] Speaker 03:
And so that's all the disclosure they have in the specification.

[00:23:16] Speaker 03:
And the board, under the broadest reasonable interpretation, construed the claim to then hover those embodiments

[00:23:23] Speaker 03:
where you would add the magnesium steric during preparation of the core matrix.

[00:23:29] Speaker 03:
So unless there is any other questions, we'd ask this court to affirm the board's three obviousness decisions.

[00:23:35] Speaker 00:
Well, let me ask you about the second of the two claim construction issues, the abuse deterrent dosage issue.

[00:23:50] Speaker 00:
Why isn't that?

[00:23:52] Speaker 00:
preamble language part of the requirements of the claim.

[00:24:00] Speaker 00:
I think it doesn't matter either way, but the board did find... The board said it didn't, but it seems to me at minimum makes your case harder if it is a required limitation.

[00:24:12] Speaker 00:
Well, the board said it was just a statement of intended abuse.

[00:24:15] Speaker 00:
Because McGinnity, for one thing, doesn't specifically address, I guess it's McGinnity, doesn't address the abuse

[00:24:21] Speaker 03:
McGinnity doesn't say specifically abuse deterrent, but it's been used as a reference in numerous abuse deterrent patents that Purdue has.

[00:24:30] Speaker 00:
I understand.

[00:24:31] Speaker 00:
But at least by its terms, it doesn't bring that limitation into play.

[00:24:36] Speaker 03:
Well, the board said because it's been construed, understood to encompass OxyContin, one would understand that the OxyContin abuse problem that, in fact, you would look to McGinnity.

[00:24:45] Speaker 03:
And then even if you, then Josh teaches, in fact, that the PEO itself

[00:24:49] Speaker 03:
is providing abuse deterrent properties to what McGinney is already doing.

[00:24:53] Speaker 03:
So I think even if it's a limitation, the board, there's substantial evidence for the board's decision that you would start with McGinney and it would have abuse deterrent properties, the dosage form it's making.

[00:25:04] Speaker 03:
But the board said what we have is a plain body that's a structurally complete dosage form.

[00:25:09] Speaker 03:
There's no indication that the abuse deterrent in the preamble

[00:25:14] Speaker 03:
in any way changes the components of the claim.

[00:25:17] Speaker 03:
And so under this court's case, I said, without you didn't rely on it.

[00:25:21] Speaker 03:
The board didn't say that.

[00:25:21] Speaker 03:
There's nothing in prosecution where it was relied on.

[00:25:24] Speaker 03:
So there's nothing to say that this provides any patentable weight to the dosage form itself.

[00:25:34] Speaker 03:
I mean, their argument is then the PEO.

[00:25:38] Speaker 03:
There's something more about the PEO, but I don't see any teaching in their specification that suggests

[00:25:42] Speaker 03:
that there's a different amount of PEO you would use to get abuse deterrence versus non-abuse deterrence.

[00:25:48] Speaker 03:
It's a gelling agent.

[00:25:49] Speaker 03:
It would appear to deter abuse, regardless of necessarily the amount, or at least to some degree.

[00:25:59] Speaker ?:
OK.

[00:25:59] Speaker 03:
All right.

[00:25:59] Speaker 03:
OK, thank you.

[00:26:00] Speaker 03:
Thank you, Your Honors.

[00:26:06] Speaker 01:
Ms.

[00:26:07] Speaker 01:
Sweezy, you've got a couple of minutes here.

[00:26:10] Speaker 02:
Thank you.

[00:26:10] Speaker 02:
I appreciate the additional time.

[00:26:12] Speaker 02:
In terms of your question, Your Honor, about record statements about benefits, I have to confess I don't know that it was said in those terms.

[00:26:20] Speaker 02:
What was focused on was that the prior art did not teach or suggest this combination.

[00:26:25] Speaker 02:
But of course, as I said, benefits really is not the lens from which to review whether a claim is obvious or not.

[00:26:31] Speaker 02:
And importantly on claim construction, our claim couldn't be more abundantly clear.

[00:26:36] Speaker 02:
You have to have the thing together first before it's heeded.

[00:26:39] Speaker 02:
And I would just commend the court

[00:26:42] Speaker 02:
The agreed upon testimony throughout this case, at least in five instances, both Amiel's first expert and then their second expert, they continued to change their theory at the oral hearing.

[00:26:54] Speaker 02:
And our expert consistently agreed with the plain meaning of the claim that you have to have these three ingredients together before heating.

[00:27:01] Speaker 02:
You can't just have one.

[00:27:03] Speaker 02:
That's not a sensible reading, nor was it a sensible reading of the stipulation.

[00:27:07] Speaker 02:
And then I would.

[00:27:09] Speaker 00:
You've mentioned now a couple of times

[00:27:11] Speaker 00:
one as opposed to all three.

[00:27:13] Speaker 00:
I take it that the PTO's position would be sustained if there were two.

[00:27:24] Speaker 00:
That is to say, the PEO and the oxycodone that were heated together, but the magnesium stearate was not.

[00:27:31] Speaker 00:
Is that not correct?

[00:27:32] Speaker 02:
That's not correct.

[00:27:34] Speaker 02:
Because all three have to be.

[00:27:36] Speaker 00:
Well, I understand that.

[00:27:37] Speaker 00:
But what their position is is that magnesium stearate doesn't have to be heated with the other components.

[00:27:44] Speaker 00:
Now, I take it that their position, therefore, is that the other components can be heated together.

[00:27:49] Speaker 00:
You keep saying one, only the PEO.

[00:27:53] Speaker 02:
I apologize.

[00:27:53] Speaker 02:
Let me clear up the confusion.

[00:27:56] Speaker 02:
If they are saying that you could heat the PEO and the oxycodone together and then later add magnesium stearate and then add heat.

[00:28:04] Speaker 00:
No, no, no.

[00:28:06] Speaker 00:
My point is really just a simple one for clarification.

[00:28:10] Speaker 00:
I just want to make sure that I'm on the same track as you are.

[00:28:15] Speaker 00:
The two positions are, one is that the magnesium stearate has to be part of the core matrix at the time that the whole mix is heated.

[00:28:25] Speaker 00:
That's your position.

[00:28:27] Speaker 02:
at the time those three ingredients are heated.

[00:28:30] Speaker 00:
Right.

[00:28:30] Speaker 00:
The three ingredients that all of which, in your view, are part of the core matrix all have to be heated together.

[00:28:35] Speaker 00:
That's your position.

[00:28:37] Speaker 02:
Yes.

[00:28:38] Speaker 00:
OK.

[00:28:38] Speaker 00:
Their position is that the only thing that doesn't have to be heated as part of the core matrix is the magnesium stearate, but the oxycodone and the PEO can be heated together, right?

[00:28:51] Speaker 02:
I believe that is their position, and that is incorrect.

[00:28:54] Speaker 00:
I understand.

[00:28:55] Speaker 00:
OK.

[00:28:55] Speaker 00:
But all I'm trying to get now is what your position is, because what you said a couple of times was the, I think you said the PEO, heated alone.

[00:29:03] Speaker 00:
Or you said, I'm not sure whether you referred to the oxycodone or the PEO.

[00:29:07] Speaker 00:
I just want to make sure you are in agreement with the PTO that their position is it can be oxycodone and PEO that's heated together as long as

[00:29:20] Speaker 00:
Magnesium steroid is not.

[00:29:23] Speaker 02:
I do understand that to be their position.

[00:29:25] Speaker 00:
OK.

[00:29:26] Speaker 02:
That's fine.

[00:29:28] Speaker 02:
And that is contrary to the evidence because at the hearing, for instance, Ammuel's counsel specifically said, and this is from Appendix 8837, the PEO, the magnesium steroid, and the oxycodone all have to be together and heated at the same time.

[00:29:45] Speaker 02:
And he agreed.

[00:29:46] Speaker 02:
It's not a question.

[00:29:47] Speaker 00:
No, I understand that the expert testimony is to that effect.

[00:29:50] Speaker 02:
And that's also the council.

[00:29:51] Speaker 02:
Excuse me, Your Honor.

[00:29:52] Speaker 00:
I understand.

[00:29:53] Speaker 00:
I understand.

[00:29:55] Speaker 01:
OK.

[00:29:56] Speaker 01:
All right.

[00:29:56] Speaker 01:
Thank you.

[00:29:56] Speaker 00:
Thank you, Your Honor.