[00:00:00] Speaker 03:
cases that tell us from a from a tech versus from the a which is actually

[00:00:58] Speaker 03:
Mr. Zimmerman, you're reserving three minutes of time for rebuttal, correct?

[00:01:03] Speaker 03:
Yes, Your Honor.

[00:01:05] Speaker 01:
You may proceed.

[00:01:07] Speaker 01:
May it please the court.

[00:01:09] Speaker 01:
I'd like to address two main issues on the appeal.

[00:01:13] Speaker 01:
And first, I'd like to talk about the district court's treatment of the prosecution history, distinguishing the monolithic structure of the 177 Colombo patent.

[00:01:24] Speaker 01:
Then I'd like to shift gears and talk about the district court's treatment

[00:01:28] Speaker 01:
of the surrounding, the active core limitation, which relates to surrounding or continuity.

[00:01:36] Speaker 01:
Before you do that, I'd like to do housekeeping.

[00:01:38] Speaker 01:
Okay, Your Honor.

[00:01:40] Speaker 04:
Whenever anybody says somebody else is lying, I like to give them a chance to say, no, I'm not.

[00:01:45] Speaker 04:
Apatowus says in the red brief 41 and 42 that Apatex resorts to mischaracterizing the record by stating that Apatex proposed a construction only when the

[00:01:57] Speaker 04:
District Court required it and that, quote, Apotex's construction was fashioned for purposes of avoiding infringement and not to define the term the correct way.

[00:02:08] Speaker 04:
I want you to discuss that statement that you've mischaracterized the record.

[00:02:15] Speaker 01:
Your Honor, the construction proposed by Apotex was in no way structured to infringement.

[00:02:22] Speaker 01:
It is the correct construction

[00:02:24] Speaker 01:
in view of the intrinsic evidence and the extrinsic evidence.

[00:02:28] Speaker 01:
Now, did Apotex design its product specifically to avoid infringement under the correct construction?

[00:02:35] Speaker 01:
Yes.

[00:02:36] Speaker 01:
So we adopted the construction that is correct on the intrinsic record, and that construction necessarily leads to a finding of non-infringement.

[00:02:46] Speaker 01:
But it's not an after-the-fact litigation contrived construction.

[00:02:51] Speaker 01:
And we can go through the prosecution history, and we'll demonstrate that.

[00:02:54] Speaker 01:
Um, it's not an accident that Apotex's mini tablets don't have a coding.

[00:03:00] Speaker 01:
Everybody agreed.

[00:03:01] Speaker 01:
The district court, council for Eptalis, Apotex, the experts, the mini tablets are un-coded.

[00:03:07] Speaker 01:
There is nothing on the outside of the tablet.

[00:03:10] Speaker 01:
So the ordinary meaning of extended release coding would require a coding and the tablets were designed specifically not to have such a coding.

[00:03:19] Speaker 00:
Can I ask you, what is

[00:03:21] Speaker 00:
To one of ordinary skill in the art in this technology, what's a coding?

[00:03:26] Speaker 00:
I mean, and I'm, you know, this seems to be very important because the plain claim language says a coding surrounding said core.

[00:03:34] Speaker 00:
And so it seems like a key issues are whether this coding has holes and what does surrounding mean?

[00:03:40] Speaker 00:
Does it all encompass all enclosures or are there some holes?

[00:03:45] Speaker 01:
Okay.

[00:03:45] Speaker 01:
So the, the ordinary meaning of coding would be

[00:03:49] Speaker 01:
some type of layer on the external surface of a tablet that provides for extended release.

[00:03:55] Speaker 01:
And Dr. Klimanov said that.

[00:03:57] Speaker 01:
But here it's not just any extended release coating.

[00:04:00] Speaker 01:
It's an extended release coating comprising a water insoluble polymer membrane.

[00:04:06] Speaker 01:
So we look to the intrinsic evidence as to what that means.

[00:04:10] Speaker 01:
Dr. McGinnity, in his declaration, it's on pages 1140 and 1141 of the Joint Appendix,

[00:04:17] Speaker 01:
during prosecution of the related 8.8.2 application, discussed the extended release membrane coatings we're talking about here.

[00:04:26] Speaker 01:
And he said, there are two ways to make them.

[00:04:28] Speaker 01:
You either add a plasticizer to the polymer, and then it coalesces to form a continuous film around this core, or you spray it on without a plasticizer.

[00:04:41] Speaker 01:
And then when the solvent dries, you get a continuous coating around this core.

[00:04:48] Speaker 00:
What is the best part of the specification to support your argument that it's continuous?

[00:04:54] Speaker 00:
I mean, I think, and correct me if I'm wrong, but I think that every embodiment describes a continuous coding.

[00:05:00] Speaker 00:
But our case law says that we're not supposed to read the embodiments into the claim.

[00:05:05] Speaker 00:
So what do you think is the best part of the specification to support the continuous ID concept?

[00:05:09] Speaker 01:
OK, so you have the prosecution history where the declarant said it's a continuous coding

[00:05:16] Speaker 01:
But in column, I believe it's three of the patents.

[00:05:27] Speaker 01:
I'm sorry, it's column two.

[00:05:29] Speaker 01:
And you look at lines 27 through 31.

[00:05:34] Speaker 01:
This is the background of the invention section.

[00:05:37] Speaker 01:
It's discussing a prior art reference to Rourke.

[00:05:41] Speaker 01:
And it says there that the polymer is applied

[00:05:44] Speaker 01:
between 5% and 75% of the core surface.

[00:05:48] Speaker 01:
So when the inventor wanted to claim something less than a continuous coding, they told you.

[00:05:56] Speaker 01:
They said right here, 5% to 75% of the surface is covered.

[00:06:00] Speaker 01:
Everywhere where they talk about the embodiments of the invention, they talk about a complete covering or a continuous covering.

[00:06:08] Speaker 01:
And that's consistent with the prosecution history.

[00:06:11] Speaker 01:
And so we believe that the coding has to be continuous.

[00:06:14] Speaker 01:
And then if you look at the district court's opinion, the district court said, the ordinary meaning of surround is to enclose on all sides.

[00:06:24] Speaker 01:
So the plain language of the claim requires that the coding surround the court.

[00:06:29] Speaker 00:
Was that the ordinary meaning or one definition from the Webster's dictionary?

[00:06:33] Speaker 01:
It was the definition from the Webster's dictionary that the district court chose to put in her opinion.

[00:06:41] Speaker 01:
We agree with that meaning.

[00:06:42] Speaker 01:
It's consistent with surrounding meaning continuous.

[00:06:46] Speaker 01:
It's consistent with the prosecution history and the McGinnity Declaration that plaintiffs submitted during prosecution.

[00:06:53] Speaker 01:
There's no evidence in the intrinsic record that suggests anything less than a continuous coding that fully surrounds.

[00:07:01] Speaker 00:
Some of this prior art, I looked at a lot of the prior art in columns one and two to try to understand, as you point out, that the word surrounds

[00:07:10] Speaker 00:
You know, sometimes there's apertures.

[00:07:12] Speaker 00:
Sometimes it's described, the 838 patent, you just noted it just says there's coding, and then there's apertures, suggesting that the inventor knows how to say that.

[00:07:21] Speaker 00:
But the patent above talks about the one described above.

[00:07:24] Speaker 00:
That's a 738 patent to Rorke.

[00:07:26] Speaker 00:
That one talks about having a plasticizer which surrounds it.

[00:07:30] Speaker 00:
Here is the core.

[00:07:31] Speaker 00:
But when you look at the patent, there is one embodiment there that is described as having apertures that are drilled into the coding.

[00:07:39] Speaker 00:
So how do we deal with that kind of inconsistency in the description of the prior art?

[00:07:45] Speaker 01:
Well, when you look at this one, when they meant something less than totally surrounding, they specifically told you, they said it covers 5% to 75%, most of the embodiments on the one you're referring to are completely surrounded, which is the typical way you make these coatings.

[00:08:04] Speaker 01:
And then when you go to the McGinnity Declaration on pages 1140 and 1141,

[00:08:09] Speaker 01:
And this was submitted during prosecution by Aptalis.

[00:08:13] Speaker 01:
He's talking about the extended release coatings of the invention.

[00:08:16] Speaker 01:
And he says they're continuous.

[00:08:19] Speaker 01:
It's a continuous film, which would support going all the way around.

[00:08:23] Speaker 01:
But he also says it's permeable.

[00:08:25] Speaker 01:
It has to be that water can get in and water can get out.

[00:08:29] Speaker 01:
But that doesn't mean there's a hole in it.

[00:08:30] Speaker 01:
It means that it's permeable.

[00:08:32] Speaker 00:
If there was a hole in it, would the invention work for its intended purpose?

[00:08:36] Speaker 01:
It depends what particular type of coating you use.

[00:08:39] Speaker 01:
You can apply certain hard coatings where you would put holes in by design because it's not a permeable coating.

[00:08:48] Speaker 01:
But that's not the case with the type of water and soluble polymer membranes we're talking about here.

[00:08:53] Speaker 01:
And all of the technical documents that discuss membranes describe them as encircling a cork.

[00:09:00] Speaker 01:
And tellingly, although the district court said surround means to enclose on all sides,

[00:09:06] Speaker 01:
She specifically rejected the idea of continuity.

[00:09:10] Speaker 01:
We view that as a claim construction error.

[00:09:12] Speaker 01:
And when it's correctly construed, you do need a continuous coding.

[00:09:17] Speaker 01:
And then in her infringement findings, she adopted Dr. Muzzio's testimony where he says the polymer covers a significant fraction.

[00:09:26] Speaker 01:
It's predominantly polymer.

[00:09:29] Speaker 01:
He admitted on Appendix 1893 that he made no effort to quantify

[00:09:36] Speaker 01:
how much of the cyclobenzaprine particles in Apotex's mini tablets are covered.

[00:09:44] Speaker 01:
So there is no evidence to suggest a complete coding.

[00:09:49] Speaker 01:
How does the prosecution history help you here?

[00:09:52] Speaker 03:
The prosecution history helps in two ways.

[00:09:54] Speaker 03:
And show me the evidence that there was a clear and unmistakable disavow.

[00:09:59] Speaker 01:
We are not arguing a clear and unmistakable disavow here.

[00:10:03] Speaker 01:
We have never argued that to the district court.

[00:10:05] Speaker 01:
We're not arguing it here.

[00:10:06] Speaker 01:
The prosecution history helps in two ways.

[00:10:09] Speaker 01:
First, with respect to surrounding or continuous.

[00:10:13] Speaker 01:
I already pointed you to 1140, 1141.

[00:10:15] Speaker 01:
That's the McGinnity Declaration, where he's talking about the extended release codings.

[00:10:20] Speaker 01:
And he says that they're a continuous film.

[00:10:24] Speaker 01:
So we think that means surround has to go all the way around and be continuous.

[00:10:29] Speaker 01:
It helps in a second way, though, and that's at Joint Appendix 3325.

[00:10:33] Speaker 01:
During prosecution, the applicants distinguished their invention from a prior art patent to Colombo.

[00:10:43] Speaker 00:
Is this the parent prosecution history?

[00:10:45] Speaker 01:
Yes, this is during prosecution of the parent 793 patent.

[00:10:50] Speaker 01:
And at page 3325, the examiner rejected the claims over the Colombo 177 patent.

[00:10:58] Speaker 01:
And that teaches a matrix.

[00:11:01] Speaker 01:
There's no dispute that that teaches a matrix.

[00:11:04] Speaker 01:
And the applicants distinguished their extended release coded beads from a matrix.

[00:11:10] Speaker 01:
And they specifically said, granulates that are compressed in the tablet form are insufficient to anticipate or to render obvious.

[00:11:19] Speaker 01:
Each of the beads is individually coded with an extended release coding.

[00:11:24] Speaker 01:
The granulates of the 177 patent, by contrast,

[00:11:28] Speaker 01:
are compressed into a monolithic structure.

[00:11:32] Speaker 01:
And those were the words chosen by Aptalys.

[00:11:35] Speaker 01:
There was no dispute at trial that a monolithic structure is a matrix.

[00:11:41] Speaker 01:
And apotexis tablets are formed by mixing the materials together, forming granulates, and then compressing them into tablets, exactly like Colombo.

[00:11:51] Speaker 01:
So whatever the extended release coding is in the context of this patent,

[00:11:57] Speaker 01:
The prosecution history shows it can't embrace a monolithic structure or a matrix like Apotex has.

[00:12:05] Speaker 00:
Now the examiner didn't adopt that argument or didn't agree with it, but I guess it's your position that it still is helpful in understanding how the claim should be interpreted.

[00:12:15] Speaker 00:
It is helpful.

[00:12:17] Speaker 01:
And it's not a disclaimer because I view disclaimer as when the ordinary meaning is broad enough to encompass something and the applicant says, no, no, we don't want to include that.

[00:12:27] Speaker 01:
That's a disclaimer.

[00:12:28] Speaker 01:
When an applicant says, our invention is this, not this, they're making a distinction, but they're not describing something that's otherwise covered.

[00:12:38] Speaker 01:
And here we have that situation.

[00:12:40] Speaker 01:
They're just telling you what the... It's definitional.

[00:12:42] Speaker 01:
It's definitional rather than a disclaimer of something that would otherwise be covered by the ordinary meaning.

[00:12:48] Speaker 01:
And it's not just our view that the prosecution is helpful.

[00:12:53] Speaker 01:
If you look at the district court's opinion at page 10,

[00:12:56] Speaker 01:
and 10, note 13.

[00:12:59] Speaker 01:
The district court originally didn't consider the prosecution history in reaching her claim construction.

[00:13:05] Speaker 01:
But after trial, when the prosecution history was presented through an expert, she then said that it informs the court's infringement analysis and it informs the understanding of extended release codings.

[00:13:18] Speaker 01:
So clearly, even the district court thought it was worth considering.

[00:13:22] Speaker 01:
But then strikingly, she says,

[00:13:25] Speaker 01:
Nowhere in the cited prosecution history were the terms membrane or matrix system used, not in the 177 patent or in the prosecution history.

[00:13:34] Speaker 01:
And then she dismisses the prosecution history.

[00:13:37] Speaker 01:
The fact that it doesn't use those words in high verba doesn't change the fact that they distinguish extended release codings from monolithic structures, which everybody agrees are matrices.

[00:13:50] Speaker 01:
So the district court never really conducted an analysis

[00:13:54] Speaker 01:
of what the prosecution history means.

[00:13:56] Speaker 01:
I see that I'm into my rebuttal time.

[00:13:58] Speaker 01:
If there are other questions.

[00:14:00] Speaker 03:
No other questions.

[00:14:01] Speaker 03:
We'll restore you to three minutes.

[00:14:02] Speaker 03:
Thank you, Your Honor.

[00:14:05] Speaker 02:
Mr. Lane.

[00:14:08] Speaker 02:
Good morning, Your Honors.

[00:14:08] Speaker 02:
John Lane from Fish and Richardson from the Pellies.

[00:14:13] Speaker 02:
On the claim construction, there were two points I wanted to make.

[00:14:16] Speaker 02:
I'm sure you'll have questions too, but... We do.

[00:14:20] Speaker 04:
When I first read the claim construction, it sounded

[00:14:24] Speaker 04:
reasonable to me.

[00:14:26] Speaker 04:
But reviewing the claim construction order and the opinion, I couldn't find any intrinsic evidence supporting that a coding is a, quote, layer of any substance applied to another.

[00:14:41] Speaker 04:
In fact, it sort of looks like the district court obtained that definition from a dictionary that wasn't pro-offered.

[00:14:50] Speaker 04:
It's certainly exactly the definition

[00:14:53] Speaker 04:
in Webster's third in 1986, which defines coding as a layer of any substance used as a cover, protection, and so on.

[00:15:07] Speaker 04:
Do you know whether the district court got that definition somewhere other than intrinsic evidence?

[00:15:14] Speaker 04:
And if not, where is it?

[00:15:17] Speaker 02:
Well, here, importantly,

[00:15:20] Speaker 02:
Which Apotex never says in its appeal brief, but below, and this is in the appendix of 1578, both parties agreed that the term extended release coding should have its plain and ordinary meaning.

[00:15:32] Speaker 02:
And both sides proposed constructions that they said were the plain and ordinary meanings.

[00:15:39] Speaker 02:
And by virtue of the fact, well, both parties also agreed there was no express definition in the specification of the prosecution history.

[00:15:46] Speaker 02:
So what I think the district court did, but I don't know for sure, but it's, it appeared that she took, the judge took words from the various proposed ordinary meanings from the parties and cobble those together into a definition that was somewhere between the two parties proposed ordinary meaning definitions.

[00:16:09] Speaker 00:
What is the ordinary meaning of coding and the context of pharmaceuticals?

[00:16:15] Speaker 00:
Why isn't it something that goes around a core, rather like a gobstopper?

[00:16:22] Speaker 02:
Well, I think fundamentally, it is something that goes around a core.

[00:16:27] Speaker 02:
But I think the second part of your question, like a gobstopper, gets at this distinction between what Apotex calls a membrane system, which would be something like, I understand a gobstopper would be versus, for example, a matrix, what they call a matrix system, where you have this dry coating form

[00:16:45] Speaker 02:
by compacting very, very small polymer particles onto larger drug particles.

[00:16:54] Speaker 00:
But doesn't the claim say that it comprises a membrane, which I understand the parties interpreted as being a covering, but that doesn't necessarily mean that the claim doesn't have the word membrane in it?

[00:17:06] Speaker 02:
Well, if I may address one point first.

[00:17:11] Speaker 02:
It was undisputed that these types of dry coatings that Aputex uses were known in the prior art.

[00:17:16] Speaker 02:
And in fact, in column 6, this exact type of the granulates that Aputex uses are described expressly in column 6, line 23 to 33 as one embodiment of the invention.

[00:17:31] Speaker 02:
I guess the question is whether it's claimed, right?

[00:17:35] Speaker 02:
Right.

[00:17:35] Speaker 02:
So the claim includes the term membrane.

[00:17:38] Speaker 02:
But the parties agreed expressly that that term simply meant covering in the context of these patents.

[00:17:46] Speaker 03:
Would a person skilled in the art take the term membrane as used in this industry, in pharmaceuticals, and say that it's simply a coating?

[00:18:00] Speaker 02:
A coating or a covering?

[00:18:01] Speaker 03:
A covering, I'm sorry.

[00:18:03] Speaker 02:
Well, I think they would because that was what the parties agreed.

[00:18:08] Speaker 02:
And in cases in this court, many cases, for example... I know what the parties agreed to.

[00:18:14] Speaker 03:
And then the court reverted to what it was looking for a plain meaning in the words, but it just seems to me that the word membrane is used in the claims.

[00:18:24] Speaker 03:
And that was kind of like left behind somewhere.

[00:18:28] Speaker 02:
Right.

[00:18:28] Speaker 02:
But again, that was an agreed construction, so no one

[00:18:34] Speaker 02:
Aptal has never had any reason to go beyond that and no record was created about these questions you're asking.

[00:18:41] Speaker 00:
Well, I guess my, I understand that when we engage in claim construction, one of the first things we do is we look at the plain claim language and that could be the words themselves that are being defined.

[00:18:52] Speaker 00:
But you also have to look at the other language surrounding those words that are being defined.

[00:18:57] Speaker 00:
The words like surrounding a core and words like comprising a membrane.

[00:19:02] Speaker 00:
I don't think there might be other limitations to claim as well, but those suggest something.

[00:19:06] Speaker 00:
It's something what I visualize, but this is why I'm asking about what one of ordinary skill in the art would understand.

[00:19:14] Speaker 00:
But just looking at those terms, it sounds like it's a gobstopper or more of a gobstopper than, I don't know, a matrix formulation.

[00:19:24] Speaker 02:
I understand that, but here, your honor, the parties who are sophisticated about the technology agreed that was not the case.

[00:19:32] Speaker 00:
You're saying that they agreed that it's not a film surrounding a core, a drug core?

[00:19:39] Speaker 02:
No, they agreed that a membrane in the context of this patent was simply a covering.

[00:19:45] Speaker 00:
And so you think the word covering is broader than membrane?

[00:19:50] Speaker 02:
I think so, and the district court also noted that during the claim construction.

[00:19:53] Speaker 02:
But we do review claim construction to know about, right?

[00:19:56] Speaker 02:
Yes, you're on a but claim construction that are actually on appeal.

[00:20:01] Speaker 02:
That

[00:20:01] Speaker 02:
claim construction, water and solvent polymer membrane is not on appeal.

[00:20:05] Speaker 00:
I understand.

[00:20:07] Speaker 00:
I was just going to say, but again, tell me why I'm not supposed to look at the words that are surrounding the term that is on appeal, which is extended release coding.

[00:20:15] Speaker 00:
Why should I look at other words in the claim to try to understand what that means?

[00:20:19] Speaker 02:
Well, I think that's the law, that you should look at those other words in the claims.

[00:20:23] Speaker 02:
But here, Apotex's own proposed definition

[00:20:29] Speaker 02:
of extended release coding didn't draw that distinction, which the district court noted.

[00:20:33] Speaker 02:
Its own proposed construction, continuous outer film applied onto the surface of the active cores, doesn't expressly draw a distinction between matrix and membrane.

[00:20:45] Speaker 02:
So you've heard throughout these briefs about this distinction.

[00:20:50] Speaker 00:
But it does require continuous and it does require outer, right?

[00:20:54] Speaker 00:
I mean,

[00:20:55] Speaker 00:
Those are kind of the definitional words that differ in their construction from your proposed construction, right?

[00:21:02] Speaker 02:
Yes, exactly.

[00:21:03] Speaker 02:
But I would point out the word continuous is never used at all in the specification.

[00:21:11] Speaker 00:
Apertures aren't used in the specification either.

[00:21:13] Speaker 00:
Do you think the preferred embodiment in the specification includes an embodiment in which there's a coding that has apertures?

[00:21:23] Speaker 02:
In a general sense, I think all of these systems have to have some type of pore apertures, as our expert said in a claim construction declaration, in order for them to work.

[00:21:34] Speaker 02:
If the coating was absolutely continuous, the gastrointestinal fluids couldn't penetrate the coating and the drug couldn't go out.

[00:21:40] Speaker 02:
So they all have to have some type of holes.

[00:21:43] Speaker 00:
You would read the word continuous as meaning that something that surrounds the drug core but doesn't have holes that I can see.

[00:21:52] Speaker 00:
that that's not continuous because there's little tiny micropores in there?

[00:21:59] Speaker 02:
I think the plain meaning of continuous, and now we're getting into defining claim constructions, but our expert submitted a declaration during claim construction that said that in his understanding the word continuous would not include these pores and cores.

[00:22:16] Speaker 02:
That wouldn't be the ordinary understanding of the word continuous.

[00:22:22] Speaker 04:
You argue in the red brief that the prosecution history is irrelevant.

[00:22:29] Speaker 04:
And the district court said that it was never joined in discussing whether the claim language would exclude matrix systems.

[00:22:41] Speaker 04:
It was in evidence.

[00:22:45] Speaker 04:
Right.

[00:22:46] Speaker 04:
It was in evidence.

[00:22:47] Speaker 04:
So if it's in evidence, under Markman, shouldn't we consider it?

[00:22:53] Speaker 02:
I think two points.

[00:22:55] Speaker 02:
I think what the district court meant when it said join was my point earlier, that Apotex never proposed a construction for extended release coding that got at that difference.

[00:23:08] Speaker 02:
And it agreed that a membrane was something else.

[00:23:10] Speaker 02:
It should be defined broadly as a covering.

[00:23:14] Speaker 02:
And to your second point,

[00:23:17] Speaker 02:
If you look at the cases cited in our brief about this disclaimer versus whether you can just look at the prosecution history generally, as Apotex is arguing, the cases we cited, Ecolab versus FMC, MIT versus Shire, those cases had very similar fact patterns to here where there was a disagreement with the examiner.

[00:23:38] Speaker 02:
And the specification suggested that the invention was broader.

[00:23:45] Speaker 02:
And in those places, those are clearly disclaimer cases.

[00:23:49] Speaker 02:
The cases that Apotech cites in its brief, Nystrom... They're not arguing disclaimer.

[00:23:56] Speaker 04:
They're arguing, as I said in dialogue, definitional.

[00:23:59] Speaker 02:
Right.

[00:23:59] Speaker 02:
But what I'm trying to get at, and maybe I didn't make the point clearly, is that's not appropriate here.

[00:24:04] Speaker 02:
In cases like this, with this fact pattern with the examiner,

[00:24:08] Speaker 02:
and the applicant disagreeing and then that disagreement not being resolved and the applicant moving away from that argument and distinguishing the prior order on another basis.

[00:24:19] Speaker 02:
That's the fact pattern in Ecolab.

[00:24:20] Speaker 02:
That's the fact pattern in MIT.

[00:24:24] Speaker 02:
And under, in those cases, those were disclaimer cases.

[00:24:28] Speaker 00:
They were, but this is a, what about just whether it could relate to claim construction, not being dispositive?

[00:24:35] Speaker 00:
the claim construction, but maybe some evidence that would support a claim construction.

[00:24:41] Speaker 02:
I don't believe that's appropriate.

[00:24:42] Speaker 02:
I believe that the Apotex should be held to its burden under the disclaimer doctrine because it's trying to limit the claim terms based on the prosecution history.

[00:24:57] Speaker 04:
You're saying there's no clear disclaimer, so you can't look at it.

[00:25:02] Speaker 02:
Josh?

[00:25:03] Speaker 02:
I'm saying that the proper analysis is under the disclaimer standard because the cases Zapotec cites Nystrom, GNPE, and Fenner weren't this type of case.

[00:25:15] Speaker 02:
They're a different type of case than Ecolab and MIT, where there's a distinction between what's in the specification and the prosecution history.

[00:25:24] Speaker 02:
In other words, the prosecution history

[00:25:27] Speaker 02:
the applicants argued for something narrower than what they said their invention was in the specification.

[00:25:31] Speaker 02:
That's the fact pattern.

[00:25:33] Speaker 00:
What about Phillips, which says that we can consider the prosecution history as part of the intrinsic record when determining claim construction?

[00:25:41] Speaker 02:
Phillips says that, but Phillips also very clearly quoting Vitronix says that the purpose of which is to find, is to see if there's a disclaimer.

[00:25:48] Speaker 00:
Not a disclaimer, but a definition.

[00:25:51] Speaker 00:
It might be, I don't, so your point is that

[00:25:55] Speaker 00:
The only way that the prosecution history can relate to claim construction is if there's a disclaimer, just to make sure we understand your position.

[00:26:02] Speaker 02:
In this type of case with this type of fact pattern, like in Ecolab and MIT, where there's a difference between what the applicants said in the prosecution history and the specification, there's another line of cases, which Appitex cited in its briefs, the Nystrom, Fenner, and GMP cases, where the court found there's a specific agreement

[00:26:24] Speaker 02:
between what the applicant said in the prosecution history and what they said in the specifications.

[00:26:29] Speaker 02:
And in those cases, especially in Nystrom, the court expressly found that in those circumstances, you don't need a disclaimer.

[00:26:38] Speaker 02:
But interestingly, in Nystrom at page 1048, on another claim term, the district court said the disclaimer standard was appropriate.

[00:26:47] Speaker 02:
But again, the court said in the first claim term, it wasn't a disclaimer.

[00:26:52] Speaker 02:
case in Nystrom because the applicant described their invention the exact same way in the specification and in the prosecution history, again, in contrast to the other line of cases, Ecolab, MIT, in this case, where the applicants describe their invention and specification more broadly than how they characterized it during the prosecution history.

[00:27:15] Speaker 00:
And that, in those cases... Your argument does require us to agree with your understanding of how the specification should be read.

[00:27:23] Speaker 02:
Right.

[00:27:24] Speaker 02:
And one point, if I may, that I'd really like to make, because I think it's really important to a lot of arguments that are being made here.

[00:27:34] Speaker 02:
In our red brief at pages 47 to 48, we made an argument about column 6 in the specification, which is Appendix 36, lines 23 to 33, which starts, that paragraph starts, in certain embodiments.

[00:27:50] Speaker 02:
And it describes what's called a rate-controlling polymer being combined with the drug to form granulates.

[00:27:58] Speaker 02:
In Apotex's product, they use the exact same language, a rate-controlling polymer combined with a drug to form granulates.

[00:28:09] Speaker 02:
What's described in column 6 is exactly the type of granulates that Apotex makes.

[00:28:14] Speaker 02:
They combine the rate-controlling polymer, which everybody agreed at trial is what causes the extended release with the drug into granulates.

[00:28:23] Speaker 02:
Apotex tells you this in its brief at page 10, and then those granulates are compressed in the mini tablets.

[00:28:29] Speaker 02:
And then you go to column 7, and in PEDMICS 37, lines 15 to 20, and it's... Can you point me exactly what lines you're looking at in column 6?

[00:28:39] Speaker 02:
Yes, it's appendix 36.

[00:28:41] Speaker 02:
I'm sorry if I spoke too fast.

[00:28:43] Speaker 00:
That's all right.

[00:28:44] Speaker 02:
It was column six, lines 23 to 33.

[00:28:48] Speaker 02:
And that, in our view, is expressed disclosure, again, of combining a rate-controlling polymer with the active drug to form granulates, which is exactly the way that Apotex makes its product.

[00:29:06] Speaker 02:
And we made this point in the red brief

[00:29:08] Speaker 00:
Can I ask you though, it talks about how that is your extruded spheronized core, but then that's the core then that's surrounded by a coating, right?

[00:29:19] Speaker 02:
No, I don't agree with that because you're forming granulates, just like Apotex does, of the rate controlling polymer.

[00:29:26] Speaker 02:
That's, as everyone agreed at trial, the experts agreed, that is what causes the extended release.

[00:29:32] Speaker 02:
You don't

[00:29:33] Speaker 02:
You don't put another extended release coding.

[00:29:35] Speaker 00:
You could put another... Where does it say that though, in the specification, that you don't put an extended release coding on that?

[00:29:43] Speaker 00:
Because I hear what you're saying.

[00:29:45] Speaker 00:
I understand that in the matrix formulation, there's already something that's going to provide for the extended release.

[00:29:51] Speaker 00:
But I suppose it wouldn't be crazy to put a coding on as well, and then you have even more extended release.

[00:29:59] Speaker 00:
And I don't see where in the patent it says, clearly,

[00:30:03] Speaker 00:
whether this core made this way has a coding on it or not.

[00:30:07] Speaker 02:
Well, there's many embodiments to describe, and the specification talks about putting codings on cores that do have, that are already extended release.

[00:30:19] Speaker 02:
So there's a number of possibilities, in other words.

[00:30:20] Speaker 02:
So I don't think that the specification precludes someone from putting extended release coding on those types of granules that are formed.

[00:30:30] Speaker 02:
On the other hand, the specification certainly doesn't say that you must or indicate in any way specifically that in that embodiment that's described in that paragraph, that a membrane coding is added to that formulation after the granulates are formed.

[00:30:48] Speaker 02:
And I think the evidence supporting that is in column 7, appendix 37 at 15 to 20, where it says the invention can be

[00:30:58] Speaker 02:
implemented using the granulates.

[00:31:01] Speaker 02:
I guess I just had one more question.

[00:31:05] Speaker 00:
I wanted to ask you about a particular language that it talks about, it's in column five, and it says those young in the art will be able to select an appropriate amount of drug for coding onto or incorporating into the core.

[00:31:23] Speaker 00:
Is that language, the amount of drug coding onto

[00:31:27] Speaker 00:
Is that referring to where there's a drug core of the non-matrix type?

[00:31:32] Speaker 00:
And then the language that talks about incorporating into the core, is that for the type of matrix drug or spheronized core?

[00:31:43] Speaker 02:
Right.

[00:31:43] Speaker 02:
If you look at column five in that language, it's talking about another type of formulation where you have these film form membranes.

[00:31:52] Speaker 02:
But in column six, you're talking about a different

[00:31:56] Speaker 02:
type of embodiment, as the language says.

[00:31:59] Speaker 02:
It says in accordance with certain embodiments in that paragraph in column six of lines 23 to 33.

[00:32:07] Speaker 00:
So I think... Does that suggest then that the spiralized core is not coded?

[00:32:14] Speaker 02:
Yes, I think it... I don't think it suggests either way that whether it's coded or not, but the point is that it's describing a formulation that combines the rate-controlling polymer

[00:32:26] Speaker 02:
with the drug to form the granules.

[00:32:29] Speaker 02:
And that's exactly what Apotex does.

[00:32:31] Speaker 02:
Whether you coat that later or not, as I see it, I don't think the specification indicates that you must or you can't either way.

[00:32:40] Speaker 02:
But again, what it's showing is that the type of formulation that Apotex uses, these granulates that are combined, a combination of what Apotex calls the rate-controlling polymer and what the specification also calls the rate-controlling polymer,

[00:32:55] Speaker 02:
with the drug are formed.

[00:32:58] Speaker 02:
Thank you.

[00:33:08] Speaker 01:
Thank you, Your Honor.

[00:33:08] Speaker 01:
I'll be brief.

[00:33:09] Speaker 01:
I have two points.

[00:33:11] Speaker 01:
The first one is counsel pointed to column six and then to column seven for this treatment of what they say is polymer mixed with active and that that can be the invention.

[00:33:25] Speaker 01:
And they specifically rely in their brief at column 7, lines 15 through 20, which says you can use different multiparticulates, i.e.

[00:33:37] Speaker 01:
pellets, beads, granules, or mini-tabs.

[00:33:40] Speaker 01:
And they say, that's what Apotex is doing.

[00:33:43] Speaker 01:
But if you look in that same column 7, lines 4 through 14, it tells you, in general, it is desirable to prime the surface of the particle

[00:33:53] Speaker 01:
before applying an extended release membrane coating.

[00:33:57] Speaker 01:
And then it tells you at line 11, the membrane coatings can be applied to the core using any coating techniques commonly used in the industry.

[00:34:06] Speaker 01:
When you read columns six and seven in their entirety then and put this all together, what they're telling you is this core can be a pellet, a bead, a granule, a mini-tab, and then you coat it.

[00:34:20] Speaker 01:
The claim expressly requires

[00:34:22] Speaker 01:
an extended release coding comprising a membrane.

[00:34:26] Speaker 01:
They didn't claim any systems that don't use a coding.

[00:34:30] Speaker 01:
Their patent doesn't describe any extended release systems that don't have a membrane coding.

[00:34:37] Speaker 01:
Except in column three, when, I'm sorry, in column one, the only discussion of a matrix in this patent is column one

[00:34:51] Speaker 01:
line 57 where they're talking about combining drug and polymer to make a matrix and they're distinguishing the prior art.

[00:35:00] Speaker 01:
It's clear that a matrix is a different type of system than the extended release membrane coatings that these inventors used.

[00:35:09] Speaker 01:
Now the other thing I want to discuss just briefly is the issue of covering and that somehow this broadens the claim to get rid of membrane and suddenly you can have

[00:35:20] Speaker 01:
Things that aren't coated, they're just matrices.

[00:35:24] Speaker 01:
There was a disagreement about the construction of membrane coating.

[00:35:28] Speaker 01:
The parties proposed different definitions, but the claim says it's a water insoluble polymer membrane surrounding the core.

[00:35:39] Speaker 01:
So, leaving aside the word membrane, it's made of polymer, it surrounds this core, and it's part of the coating.

[00:35:46] Speaker 01:
That's what the coating comprises.

[00:35:49] Speaker 01:
I've thought about what other words you could use for membrane.

[00:35:51] Speaker 01:
It's a covering or a film.

[00:35:55] Speaker 01:
We weren't suddenly saying you eliminate membrane from this claim and it can cover matrices or any other type of extended release system.

[00:36:04] Speaker 01:
It was simply a way to try to provide meaning, but clearly the extended release coding has to be a membrane.

[00:36:10] Speaker 01:
Are there any other questions?

[00:36:12] Speaker 03:
No, thank you very much.

[00:36:13] Speaker 03:
Thank you.

[00:36:14] Speaker 03:
We thank the parties for their arguments.