[00:00:00] Speaker 01:
pharmaceutical.

[00:00:58] Speaker 04:
Good morning, Your Honors.

[00:00:59] Speaker 04:
May it please the court?

[00:01:00] Speaker 04:
The district court below erred in the Dr. Reddick.

[00:01:05] Speaker 01:
I'll start off as a preface for this.

[00:01:07] Speaker 01:
There's obviously an overlap between this case and the earlier case.

[00:01:10] Speaker 01:
And the district court here, I understand, adopted Judge Stark's claim construction.

[00:01:15] Speaker 01:
So do you have anything to add to the other side's argument with respect to claim construction?

[00:01:22] Speaker 04:
That's what I wanted to go to right away, Judge Frost, and amplify on a couple of comments that Mr. Nash made.

[00:01:28] Speaker 04:
before.

[00:01:30] Speaker 04:
First, on the section of the specification of the 0322 specification, the new language regarding a matrix having two portions, I want to note that in our case, the Amniel case, the Amniel's expert, Dr. Gemeinhart, agreed with the interpretation of that section that it discloses that a matrix, a sustained release formulation itself, can have two portions, an IR and an SR portion.

[00:01:56] Speaker 04:
I'd also like to point to a couple of other changes in the 032 specification.

[00:02:02] Speaker 04:
There's significant new disclosure in the 032 pad.

[00:02:05] Speaker 04:
One at column 21, lines 40 to 50.

[00:02:11] Speaker 04:
The spec says for the 032 pad, the sustained release formulation alone may be formulated to mimic the blood serum profile of

[00:02:25] Speaker 04:
And then it refers to mucinix.

[00:02:27] Speaker 04:
And mucinix is the comparator product that is referenced in the 032 patent claims.

[00:02:32] Speaker 04:
So it clearly says a sustain-laced formulation alone, just a non-layered matrix tablet, can have the PK requirements that are called by that claim.

[00:02:40] Speaker 04:
And the similar language is repeated in the 032.

[00:02:43] Speaker 03:
Sorry, what are you, what column?

[00:02:45] Speaker 04:
Oh, sorry, your honor, column 21, lines 40 to 50 of the 032 patent.

[00:02:50] Speaker 04:
That's new disclosure.

[00:02:54] Speaker 03:
Oh, 21.

[00:02:56] Speaker 03:
What lines?

[00:02:58] Speaker 04:
Lines 40 to 50.

[00:02:59] Speaker 04:
So really, I guess we would start at maybe 42.

[00:03:07] Speaker 03:
Yeah, that would be it.

[00:03:09] Speaker 03:
I was looking at the wrong pattern.

[00:03:11] Speaker 03:
OK.

[00:03:11] Speaker 04:
Sorry.

[00:03:11] Speaker 04:
If you really start at line 42, it says, the sustained release formulation alone, or in combination with an immediate release component, may be formulated to mimic the blood serum profile of boyfinicin

[00:03:24] Speaker 04:
et cetera, et cetera, and then it refers to Mucinix.

[00:03:28] Speaker 04:
Mucinix is the comparative product that's referenced in the claims of the 032 patent.

[00:03:35] Speaker 04:
And similar languages is found again in 032 patent at columns 13, lines 23 to 30.

[00:03:43] Speaker 04:
This is an important difference between the 032 spec and the 252 spec.

[00:03:48] Speaker 04:
They changed the disclosure to clearly show that a matrix tablet, sustainable lease formulation, can have two portions.

[00:03:57] Speaker 04:
And Dr. Gamaymar admitted that's what those sections say.

[00:04:04] Speaker 03:
I guess I don't understand.

[00:04:06] Speaker 03:
OK, I understand you're telling me that this new language is added.

[00:04:12] Speaker 03:
It's not crystal clear to me that it makes a difference.

[00:04:15] Speaker 03:
But even if that language theoretically makes a difference,

[00:04:18] Speaker 03:
Claims one still requires two portions, two portions, not one portion.

[00:04:22] Speaker 03:
It's not entirely SR or entirely IR.

[00:04:27] Speaker 03:
Claim one requires a first portion and a second portion.

[00:04:32] Speaker 03:
So what am I missing?

[00:04:36] Speaker 04:
Your Honor, it does say two portions in the claims, but it says in the spec.

[00:04:39] Speaker 03:
Not just two portions.

[00:04:40] Speaker 03:
A first portion, which is immediate release form, and a second portion, which is a sustained release form.

[00:04:46] Speaker 03:
So you pointing me

[00:04:48] Speaker 03:
to something in the spec that talks about how something could be a 100% sustained release doesn't seem to me has any relevance to claim one.

[00:04:55] Speaker 04:
No, because what I'm missing.

[00:04:57] Speaker 03:
I missed something.

[00:04:58] Speaker 04:
Yes, Your Honor.

[00:04:58] Speaker 04:
At column four, lines 12 to 17, it says that a matrix, the sustained release formulation itself, can have an IR portion and SR portion in it.

[00:05:09] Speaker 04:
So you can have two portions in a non-layered product.

[00:05:13] Speaker 04:
That's the new disclosure in the 032 patch.

[00:05:15] Speaker 03:
I'm sorry.

[00:05:16] Speaker 03:
So column four.

[00:05:18] Speaker 03:
says, but I don't understand the column 21 and the other one that you pointed to.

[00:05:25] Speaker 03:
The claim itself requires two portions.

[00:05:30] Speaker 04:
Two portions.

[00:05:31] Speaker 04:
Yes.

[00:05:31] Speaker 04:
Yes, Your Honor.

[00:05:32] Speaker 04:
A portion of Goethe-Fennessy in immediate release form and a portion in sustained release form.

[00:05:37] Speaker 04:
You've got to have two releasing portions.

[00:05:40] Speaker 04:
And that's what you have.

[00:05:41] Speaker 04:
You can have that in a sustained release formulation.

[00:05:44] Speaker 04:
That's what column four, lines 12,

[00:05:47] Speaker 04:
17 says is you can mix the IR and SR portions in a single matrix.

[00:05:53] Speaker 01:
A single matrix.

[00:05:55] Speaker 01:
A plain language talks about a first portion and a second portion.

[00:06:00] Speaker 01:
So are you suggesting that this language reads out a first portion and a second portion?

[00:06:07] Speaker 04:
No, no, no.

[00:06:08] Speaker 04:
No, Your Honor.

[00:06:08] Speaker 04:
I'm saying that this language in the spec, this new language of column four lines 12 to 17 says

[00:06:16] Speaker 04:
that a non-layered tablet can have those two portions that are required by the claim, the first and second portion.

[00:06:23] Speaker 05:
That language has changed in the specification, but the claim language is the same.

[00:06:29] Speaker 04:
Well, the claim language is not exactly the same, Your Honor.

[00:06:32] Speaker 04:
The reference, if you look just at the first portion recitation and sustained and second portion recitation, I think you also need to look at the dependent claims.

[00:06:42] Speaker 04:
But this is sort of the same situation this court confronted in the Trading Technologies case.

[00:06:47] Speaker 04:
There you had a parent case, and you had a CIP.

[00:06:51] Speaker 04:
And the parent claims used the word static during prosecution.

[00:06:54] Speaker 04:
The applicants characterized static in a way that limited those claims.

[00:07:01] Speaker 04:
The later specification added new description of static that changed the disclosure with respect to that.

[00:07:09] Speaker 04:
And the court held that the disclaimer from the first application did not apply there.

[00:07:13] Speaker 01:
So how, in your view, does the language that you were referring to in claim four change the language in the claim?

[00:07:22] Speaker 01:
The claim language is first portion for an immediate release and second portion in a sustained release.

[00:07:30] Speaker 01:
Right.

[00:07:30] Speaker 01:
So are you suggesting that this language takes out?

[00:07:35] Speaker 01:
Because the sentence you keep referring to kind of contrasts

[00:07:38] Speaker 01:
the same matrix portion, or separate release portions, which are either compressed or mixed.

[00:07:46] Speaker 01:
So what are you saying the additional language in the spec, where the language in the claim remains the same, how did it rewrite it?

[00:07:56] Speaker 04:
So the language in the spec, the new language here, says two portions can either be parts of the same matrix, non-linear tablet, or

[00:08:06] Speaker 04:
they can be separately manufactured and combined as, for example, in a bilayer tablet or in a capsule with beads.

[00:08:14] Speaker 01:
Well, you missed one word.

[00:08:15] Speaker 01:
You said the same matrix.

[00:08:17] Speaker 01:
The column four language says the same matrix portion.

[00:08:22] Speaker 01:
Right.

[00:08:22] Speaker 01:
That's one portion, right?

[00:08:24] Speaker 01:
So how does that correspond to redefining the language in this?

[00:08:29] Speaker 01:
Does that weed out in your view?

[00:08:31] Speaker 01:
the claim language distinction between a first portion and a second portion?

[00:08:35] Speaker 04:
No, it does not, Your Honor.

[00:08:37] Speaker 01:
So you think they have to show separate portions?

[00:08:39] Speaker 04:
You have to show two releasing portions, that a portion of the Goethe-Venison in the product releases immediately without any inhibition, and a portion of the Goethe-Venison in the product releases in a sustained manner.

[00:08:52] Speaker 04:
Its release is sustained, inhibited in some fashion.

[00:08:56] Speaker 04:
And that was shown at trial.

[00:08:59] Speaker 04:
That was shown at trial.

[00:09:01] Speaker 04:
If I might move on to one other point.

[00:09:08] Speaker 05:
Why did you not change the claim language in the child patent if you want the claim to say something different?

[00:09:14] Speaker 05:
Why didn't you change it to be the claim language?

[00:09:20] Speaker 05:
You're arguing that we should read the claim language differently because of these additions in the specification.

[00:09:29] Speaker 05:
I'm saying if you wanted us to

[00:09:30] Speaker 05:
actually look at the child patent in a different way in terms of scope, why didn't you change the claim language?

[00:09:39] Speaker 04:
A couple of answers, Your Honor.

[00:09:40] Speaker 04:
First, we did.

[00:09:41] Speaker 04:
At the time we presented those claims that ultimately issued in the O32 patent, we added dependent claims that required discreteness to make clear that the broader independent claims were not limited to a product where the portions were discrete or physically distinct.

[00:09:59] Speaker 04:
That we did.

[00:10:01] Speaker 04:
The other thing is when we added those claims we specifically pointed the examiner to the new disclosure and the spec saying a sustained release formulation alone can do what is called for in this claims.

[00:10:14] Speaker 04:
And on two separate occasions we told the examiner these new claims are not limited to the bilayer tablet embodiment or the capsule with beads and bindings.

[00:10:26] Speaker 04:
You got to remember

[00:10:27] Speaker 04:
There really are four embodiments disclosed in this specification.

[00:10:31] Speaker 05:
But you do agree that the independent claims are still almost identical?

[00:10:37] Speaker 04:
No, I wouldn't agree they're almost identical, Your Honor.

[00:10:41] Speaker 04:
The 252 claims require comparison to a standard immediate release formulation.

[00:10:46] Speaker 03:
These claims were... You're nitpicking with Judge Raina.

[00:10:50] Speaker 03:
They're identical in any meaningful way vis-a-vis the construction and Watson and the issues before this Court.

[00:10:56] Speaker 03:
I mean, are there nit-picky differences between them?

[00:10:59] Speaker 03:
Yes, but I'm with Jadrena.

[00:11:00] Speaker 03:
I don't see the difference between the language used in this claim with regard to the two portions and the language that was considered by this court for the 252 patent in Watson.

[00:11:11] Speaker 04:
Okay.

[00:11:12] Speaker 04:
Well, the other difference I would point to, Your Honor, is the

[00:11:17] Speaker 04:
is the dependent claims here are much different than they were in the 252.

[00:11:21] Speaker 03:
You just mean the claim three, right?

[00:11:23] Speaker 04:
Claim three and also claim seven.

[00:11:25] Speaker 04:
If you compare those to claims one and five respectively, they add, the only thing they add to the base claims is the requirement that the portions be discrete.

[00:11:34] Speaker 04:
And that's a significant difference from what this court had in the Watson case, where in the Watson opinion, the court explained that there was no claim differentiation issue.

[00:11:43] Speaker 04:
I think there is here.

[00:11:45] Speaker 04:
district court never in its opinion explained how you can have something that would infringe claim one, but not claim three.

[00:11:52] Speaker 03:
There is no, as applied, as the district court... The claim differentiation is a tool, but it's like the least preferred of all the claim construction tools.

[00:12:03] Speaker 03:
Yes, it's a tool that we use, but in this case, you had a disclaimer vis-a-vis Watson, which arguably is pulled through to this child application.

[00:12:13] Speaker 03:
You know, claim differentiation has to give way.

[00:12:15] Speaker 03:
I just don't understand as a matter of law.

[00:12:20] Speaker 03:
I mean, look, I know why you didn't change the claim language.

[00:12:22] Speaker 03:
This patent, the 032 was filed in 2003 and issued in 2010 and Watson was decided in 2011.

[00:12:30] Speaker 03:
So you didn't know at the time of the prosecution of the 032 that we were going to conclude vis-a-vis Watson that this disclaimer definitely applied.

[00:12:41] Speaker 03:
So that's why

[00:12:42] Speaker 03:
you don't have greater clarity in these claims.

[00:12:44] Speaker 03:
I mean, I'm sure the company wishes it could go back in time and re-prosecute this differently in light of what now it knows from Watson.

[00:12:52] Speaker 03:
But I guess my question to you is, what should the legal standard be?

[00:12:55] Speaker 03:
There's a disclaimer in the parent.

[00:12:58] Speaker 03:
This is a CIP.

[00:12:59] Speaker 03:
But most, I'll be honest, most of what you point to in the spec, I don't see pulled through to the claim, which still requires a first and a second portion.

[00:13:06] Speaker 03:
So what should the legal test be

[00:13:09] Speaker 03:
for your obligation to put the public on notice once you disclaim something in the parent that you are now recapturing it in the child.

[00:13:19] Speaker 03:
What should your legal obligation be?

[00:13:21] Speaker 03:
What should the test we use be?

[00:13:24] Speaker 04:
I think the test is really what was used in the training technologies case and the facts there... State the test.

[00:13:30] Speaker 03:
I don't care about the facts.

[00:13:31] Speaker 03:
Tell me the law.

[00:13:33] Speaker 03:
What should the law be?

[00:13:34] Speaker 03:
What is the obligation on the part of the patentee in a child application when the parent has a disclaimer to disavow the disclaimer?

[00:13:42] Speaker 03:
What's the obligation?

[00:13:43] Speaker 04:
I think you have to somehow communicate that you're seeking claims of a broader scope and we did that.

[00:13:49] Speaker 03:
Do you think somehow communicate is good enough, add a little confusion to the mixture once there's already been a determined disclaimer?

[00:13:56] Speaker 03:
Do you think that's enough, or do you think the patentee has to clearly and unmistakably reclaim once there's been a disclaimer?

[00:14:03] Speaker 04:
I think we did clearly and unmistakably reclaim.

[00:14:05] Speaker 03:
I'm not asking you what you did.

[00:14:07] Speaker 03:
I'm asking you what the legal test should be, because I don't think it is crystal clear in our law.

[00:14:11] Speaker 03:
And I don't understand you to be presenting a clear legal test.

[00:14:15] Speaker 03:
So I'm trying to figure out first what the law ought to be in this kind of scenario, and then I'll weigh it against your facts.

[00:14:21] Speaker 04:
I would not place it at clear and unmistakable, Your Honor.

[00:14:25] Speaker 04:
I'd place it where I put it, which is you need to signal that you're seeking claims of a broader scope.

[00:14:34] Speaker 04:
I wouldn't put it any higher than that, Your Honor.

[00:14:37] Speaker 04:
But if it is higher, I think we got there in this case because

[00:14:41] Speaker 04:
The spec changed, it specifically said two portions can be in one layer.

[00:14:47] Speaker 03:
The spec does, but the claims still require a first portion and a second portion, and that's the magic language that was viewed as causing them to have to be distinct.

[00:14:58] Speaker 03:
Right, and that's because... Look, I don't know what the difference between distinct and discrete makes.

[00:15:01] Speaker 03:
I'm having trouble making sense of that, but...

[00:15:08] Speaker 04:
You know, I keep coming back to the dependent claims as well.

[00:15:11] Speaker 04:
It made clear there were four, four volumes in the stack, a matrix tablet, two biolayer tablets, and a capsule with beads.

[00:15:19] Speaker 04:
The dependent claims specifically call for everything but the matrix tablet.

[00:15:23] Speaker 04:
There has to be some scope covered by the independent claims.

[00:15:26] Speaker 03:
It's not covered by the... I know, but I have to tell you, for me, I think the patentee has the obligation to put the world on notice as to the scope of their claims.

[00:15:35] Speaker 03:
And if the patentee has clearly and unmistakably disavowed portion of claim scope in a parent, I think the patentee has the obligation to put the world clearly on notice of the scope of the claims to the child if they're trying to reclaim it.

[00:15:48] Speaker 03:
That's what I think.

[00:15:49] Speaker 03:
I think that's the only thing that makes sense under the law.

[00:15:52] Speaker 03:
The patentee shouldn't get to issue a patent that causes all of this litigation by doing it in a less than clear way.

[00:16:03] Speaker 04:
Could there be any other questions?

[00:16:04] Speaker 04:
Could I just go very quickly into the doctrine of equivalence we did have?

[00:16:09] Speaker 04:
Sure, a couple minutes.

[00:16:13] Speaker 04:
Even if the claim construction stands, they think the court erred in three ways.

[00:16:17] Speaker 04:
One, finding there was no particularized testimony.

[00:16:20] Speaker 04:
I think that is clear.

[00:16:21] Speaker 04:
There is particularized testimony at 13.112 to 13.114 of the appendix on the function way result test.

[00:16:30] Speaker 04:
and also at 13.109 to 13.112 and 13.14 to 13.50 on insubstantial differences.

[00:16:38] Speaker 05:
Are these the same arguments that were advanced in Watson with respect to bioequivalence?

[00:16:44] Speaker 04:
No, we never got to doctrinal equivalence in Watson because the court found there was a disclaimer.

[00:16:50] Speaker 05:
The other two errors were... You're facing that same barrier here, aren't you?

[00:16:54] Speaker 04:
Well, no, neither district court found that there was a disclaimer.

[00:16:57] Speaker 04:
And we think for there to be a disclaimer, there must be a clear

[00:17:00] Speaker 04:
statement of disclaimer or disavowal.

[00:17:02] Speaker 04:
And there was none in the 032 patent.

[00:17:06] Speaker 04:
The other two errors were the court appeared to rely on the absence of a disintegrant in the product.

[00:17:11] Speaker 04:
There's no requirement for a disintegrant in the immediate release portion.

[00:17:16] Speaker 04:
And the court appeared to apply, and everything must release at once from the immediate release portion.

[00:17:22] Speaker 04:
And there's no requirement for that in the claims.

[00:17:24] Speaker 04:
Thank you.

[00:17:25] Speaker 04:
Will we start the committee?

[00:17:27] Speaker 04:
Thank you.

[00:17:32] Speaker 01:
Now, as we've already spoken, there's obviously an overlap between this case and the previous case.

[00:17:37] Speaker 01:
It's not clear to me why there are two attorneys making an argument.

[00:17:44] Speaker 01:
You said you want to divide your time.

[00:17:46] Speaker 02:
Your Honor, the reason why there are two attorneys is that Dr. Reddy's, which is the company that I represent, was only sued on one of the two patents, the 032 patent.

[00:17:55] Speaker 02:
The 821 patent was only asserted against Amnial.

[00:17:58] Speaker 02:
So the division is that I'm going to address the 03-2 on behalf of both defendants.

[00:18:03] Speaker 02:
And Mr. Danielle is going to address the other patent on behalf of Amniel.

[00:18:12] Speaker 01:
We'll run the clock separately.

[00:18:14] Speaker 02:
Thank you, Your Honor.

[00:18:15] Speaker 02:
Your Honor, I'm not going to repeat much of what has been said.

[00:18:19] Speaker 02:
At least I'm going to try not to.

[00:18:23] Speaker 02:
Obviously, we think that Judge Stark and Judge Bum decided the claim construction correctly.

[00:18:28] Speaker 02:
And the starting point is a point that Your Honors have already made, which is that the language of the claims is identical and pertinent part to the language that you already construed in Watson.

[00:18:37] Speaker 02:
It talks about two portions, one in an immediate release form and one in a sustained release form.

[00:18:44] Speaker 02:
And to the question that was posed about whether there's a difference between form and formulation, I would point Your Honors to

[00:18:52] Speaker 02:
page 6032 to 34 of the appendix, in our case, where Wreck-It uses the terms interchangeably in their mark.

[00:19:00] Speaker 02:
This is a portion of the Markman brief from below, where they made no distinction between those forms.

[00:19:06] Speaker 02:
The other point I'd like to make about the claims is that they contain two distinct requirements.

[00:19:11] Speaker 02:
One, and I think Judge Raina, you noted this, one deals with dissolution.

[00:19:15] Speaker 02:
That's the CMAX and AUC limitations.

[00:19:18] Speaker 02:
The other part of the claim deals with what structures in the formulation, I'm sorry, what structures in the product produce those claimed PK parameters.

[00:19:27] Speaker 02:
And that's where the two portions language comes into play.

[00:19:31] Speaker 02:
And I think the problem with Reckett's approach in this case is that they conflate those two elements.

[00:19:36] Speaker 02:
And what Judge Stark said, and I think this is a very good way of putting it, what he said was if you read the claims the way that Reckett wants to read them,

[00:19:48] Speaker 02:
that you fail to give meaning to the two-portion limitation beyond what meaning is separately required by the claim limitations involving the release properties of the claimed drug product.

[00:19:57] Speaker 02:
So I think that's a fundamental problem with their position.

[00:20:02] Speaker 02:
The other things I'd like to direct your attention to that I believe.

[00:20:07] Speaker 03:
I'd still like to understand the difference, which I don't really have very crystal in my head.

[00:20:12] Speaker 03:
Claim three, what is your argument with regard to claim differentiation?

[00:20:17] Speaker 03:
Claim differentiation is a weaker doctrine, and we can ignore it in this case.

[00:20:20] Speaker 03:
How does claim three differ from claim one?

[00:20:23] Speaker 02:
I certainly agree that it's a weaker doctrine, and it can overcome what I think is very clear intrinsic evidence that supports Judge Stark and Judge Bum's claim construction.

[00:20:32] Speaker 02:
That said, I think that Judge Bum, the difference between our case and the Arbindo case, Judge Bum actually construed claim three.

[00:20:39] Speaker 02:
And she concluded that it introduces a spatial relationship into the claims.

[00:20:46] Speaker 02:
And to get to that, she relied on claim four, which depends from claim three, and I believe specifies a bilayer tablet.

[00:20:53] Speaker 02:
She could equally have looked at, I believe, claims nine and 10 that talk about a coded core or a capsule with two sets of beads in it, sustained release and IR beads in it, respectively.

[00:21:07] Speaker 02:
But she concluded that,

[00:21:08] Speaker 02:
Claim three had a different scope than claim one, which I think avoids any argument on claim differentiation.

[00:21:16] Speaker 02:
I still don't understand what the different scope is.

[00:21:19] Speaker 02:
Well, there may not be any difference in scope.

[00:21:21] Speaker 02:
It may be an overlapping claim.

[00:21:23] Speaker 03:
But you said she concluded there was a difference in scope between claim one and claim three.

[00:21:27] Speaker 03:
I don't understand yet from your argument what that difference in scope is.

[00:21:31] Speaker 02:
The difference, which is a theoretical difference because there's no example of it in the patent, and I think that's why it's difficult to understand.

[00:21:38] Speaker 02:
The differences that claim one could encompass a combination of two portions, one an immediate release form and one a sustained release form, that was in some configuration other than the beads, the coated cores, and the bilayer tablets.

[00:21:56] Speaker 03:
No, those are examples.

[00:21:59] Speaker 03:
I don't understand the difference between the word discrete.

[00:22:02] Speaker 03:
Those are examples of things that are, in fact, discrete.

[00:22:05] Speaker 03:
No problem, my grace is there.

[00:22:07] Speaker 03:
But claim three is broader than any one of those examples.

[00:22:10] Speaker 03:
It says discrete.

[00:22:12] Speaker 03:
So isn't it the case that claim one has been read to contain two discrete portions also?

[00:22:19] Speaker 02:
Well, the language that Judge Stark used was distinct portions, but I agree.

[00:22:23] Speaker 02:
It's the same difference as far as that goes.

[00:22:25] Speaker 02:
He specifically said, in fact, that there was no substantive difference between those words.

[00:22:30] Speaker 02:
As far as the difference in scope between Claim 3 and Claim 1, I think that Claim 1 could encompass two forms of Guafenison that were not in a particular spatial relationship.

[00:22:47] Speaker 02:
And I think the example.

[00:22:48] Speaker 02:
that was given earlier, which is, again, a hypothetical example, is that you could essentially take two forms and simply compress them into a tablet.

[00:22:57] Speaker 02:
So it would be like the capsule in the sense that it has two different forms of guafenisin, but in the form of a tablet.

[00:23:04] Speaker 02:
So that would be one situation where you could argue that it wasn't covered by claim three, but it was covered by claim one.

[00:23:16] Speaker 02:
The other point I'd like to address, Your Honors, too, unless Judge Moore, you had any follow-up to that, is in the specification, the examples in the specification.

[00:23:25] Speaker 02:
And this is something that Wreck-It relies on to say that the claims cover single-portion products.

[00:23:30] Speaker 02:
And in particular, they point to examples one and examples four, which are the only two examples in the patent of a single formulation, what the inventors call a sustained-release formulation.

[00:23:42] Speaker 02:
And what I want to point you to is the fact that the inventors in the patent

[00:23:46] Speaker 02:
specifically describe those examples as lacking an immediate release blend.

[00:23:50] Speaker 02:
So they specifically say, this is not a two-portion formulation.

[00:23:55] Speaker 02:
It does not have an immediate release component.

[00:23:59] Speaker 02:
And that's significant, I think, because if you look at the patent, and this is in page 196 of the appendix, there is a chart at that point.

[00:24:16] Speaker 02:
begins at line 25 of column 31, where they show what the dissolution, how the guafenisin releases from that single formulation tablet.

[00:24:25] Speaker 02:
And if you look, it releases about 22% of its guafenisin in the first hour, which is the same burst effect that Reckett argued below is the immediate release component of our product.

[00:24:38] Speaker 02:
So the point I want to make is that the inventor's own words contradict that argument.

[00:24:43] Speaker 02:
The inventor specifically said,

[00:24:45] Speaker 02:
Even though there's this burst effect, it has no immediate release portion.

[00:24:49] Speaker 05:
Where is this dissolution chart?

[00:24:51] Speaker 02:
It is on page 196 of the appendix, Your Honor, beginning at line 25.

[00:25:04] Speaker 02:
This is in relation to formulation one of example four.

[00:25:13] Speaker 03:
I know you said you're addressing the 032, and your colleague is going to address the other patent.

[00:25:19] Speaker 03:
I mean, have you said anything that is distinct to the 032 that doesn't apply to the other patent?

[00:25:24] Speaker 03:
I haven't heard you say anything that is limited to one of the patents and not the other.

[00:25:30] Speaker 02:
Perhaps not, Your Honor.

[00:25:31] Speaker 02:
I'm not trying to address the 821 patent.

[00:25:34] Speaker 02:
I think there are other things in the 821 patent that add to the picture.

[00:25:38] Speaker 02:
One other thing I want to bring your attention to, and then I'll turn the floor over to Mr. Danielle,

[00:25:42] Speaker 02:
And that is in the prosecution history.

[00:25:44] Speaker 02:
And I think if you look at what happened here, it confirms that Judge Stark and Judge Bum got the claim construction right.

[00:25:53] Speaker 02:
And specifically, I want to draw your attention to the fact that the examiner, these claims in the 032 patent originally started out as two-portion claims.

[00:26:01] Speaker 02:
They got a number of art-based rejections, and then the record canceled all the claims, and they substituted claims where they simply claimed

[00:26:11] Speaker 02:
a product containing Wafenacin that met the Cmax and AUC values in the claim.

[00:26:16] Speaker 02:
So it was a purely functional claim.

[00:26:18] Speaker 02:
And they got a 112 rejection.

[00:26:20] Speaker 02:
And interestingly, it was a claim that was even broader than the claim that they disclaimed in the parent application.

[00:26:26] Speaker 02:
The examiner came back and said, you can't have that claim.

[00:26:30] Speaker 02:
You haven't described for a person of ordinary skill what structure produces those PK values, the Cmax, and the AUC values.

[00:26:39] Speaker 02:
in the claim, and you've got to do that.

[00:26:41] Speaker 02:
And when they filed their amendment, which is when they added, they put back the two-portion language and they also added claim three, they did not say, they didn't say, you know, they identified the two portions as what produced those PK values.

[00:26:56] Speaker 02:
They didn't say, look at our single formulation values, look at our sustained release formulations.

[00:27:01] Speaker 02:
When they had the opportunity to do that, they didn't tell the examiner that you could get these PK values with a single formulation product,

[00:27:09] Speaker 02:
They specifically put back the two-portion language that was the same language that they had in the 252 application.

[00:27:16] Speaker 02:
The other point I'd like to make about that is that at the time they filed that amendment, which is where they added claim three, the examiner did not have the district court's decision in the Watson case, which is where this disclaimer argument and the word discreet first appeared.

[00:27:31] Speaker 02:
So when the examiner got this amendment, he would have had no way of knowing

[00:27:35] Speaker 02:
that there was some hidden intent there to change the scope of the claim, such that he might have reconsidered the art that was asserted against sustained release formulations in the parent application.

[00:27:45] Speaker 02:
They didn't make any remarks to say, we're claiming more broadly.

[00:27:50] Speaker 02:
When they filed the Watson decision two months after they filed the amendment, they didn't say, this is in relation to the dependent claim.

[00:28:00] Speaker 02:
Please consider this as being a broader claim.

[00:28:03] Speaker 01:
You've used a portion of your friend's time.

[00:28:06] Speaker 01:
That's fine.

[00:28:07] Speaker 01:
It's up to you two to divide it.

[00:28:08] Speaker 01:
But do you want to sit down and let him speak?

[00:28:12] Speaker 01:
Yes, Your Honor.

[00:28:13] Speaker 01:
I'll pass.

[00:28:13] Speaker 01:
We'll take off the two and a half minutes, which you exceeded your time.

[00:28:17] Speaker 01:
We're down to five minutes for you, sir.

[00:28:23] Speaker 00:
Good morning, Your Honors.

[00:28:24] Speaker 00:
May it please the court?

[00:28:26] Speaker 00:
Just a couple of points on the Hakim question, not the disclaimer.

[00:28:29] Speaker 00:
Sorry, the disclaimer issue with the standard of law that Judge Moore you were talking about is mentioned in the Hakeem case, which we cite in our brief.

[00:28:37] Speaker 00:
And according to this court's precedent, there must be sufficiently clear statements saying that you were rescinding the disclaimer and revisiting those previously broader claims.

[00:28:52] Speaker 00:
None of that went on here.

[00:28:54] Speaker 00:
In fact, Your Honor,

[00:28:55] Speaker 00:
Judge Rainer, you pointed to the similarities between the 252 and the patents in suit.

[00:29:00] Speaker 00:
During the 032 patent prosecution process, the applicants actually said that they were redrafting the claims to more closely parallel claim 24 of the 252 patent.

[00:29:15] Speaker 00:
And that is Appendix 4697-4701.

[00:29:18] Speaker 00:
So they weren't moving away from the disclaimer.

[00:29:23] Speaker 00:
making their claims more closely aligned with the 252 patent.

[00:29:27] Speaker 00:
Now, if we go to the 821 patent prosecution, the same thing happened.

[00:29:31] Speaker 00:
In the 821 patent prosecution, the examiner rejected the claims based on Drost and Dancero.

[00:29:38] Speaker 00:
And the applicant noted in their response, this is the same prior art we addressed in the parent application.

[00:29:46] Speaker 00:
And they made the same arguments.

[00:29:48] Speaker 00:
They said Drost is a formulation that does not have two portions of Wafenacin.

[00:29:53] Speaker 00:
It does not have immediate release formulation portion and a sustained release portion.

[00:29:59] Speaker 00:
So they got around Drost for the same reasons they got around that reference in the 252.

[00:30:04] Speaker 00:
Same thing with Danceroe.

[00:30:05] Speaker 00:
Danceroe does disclose an invention with two portions, but it's a different PK profile.

[00:30:14] Speaker 00:
So again, these patents were aligned during the prosecution, and there was no disavowal.

[00:30:20] Speaker 00:
As counsel mentioned earlier, Judge Stark didn't rely on disclaimer.

[00:30:23] Speaker 00:
He looked at the entirety of the intrinsic evidence, relying primarily on the plain language.

[00:30:27] Speaker 00:
As Your Honor notes in the 032, if you look at the 821, it's crystal clear.

[00:30:31] Speaker 00:
It requires an immediate release formulation and a separate sustained release formulation.

[00:30:37] Speaker 00:
There must be two formulations.

[00:30:40] Speaker 00:
So you don't need to go farther.

[00:30:43] Speaker 00:
But what the patentee did too is they distinguished between the inventive approaches in this case.

[00:30:48] Speaker 00:
You have sustained release.

[00:30:50] Speaker 00:
formulations, and then you have formulations with two formulations.

[00:30:55] Speaker 00:
This was noted in this court's decision in Watson.

[00:30:58] Speaker 00:
There's a distinction between those two inventive approaches.

[00:31:01] Speaker 00:
So, Your Honor, if you look at, for example, the appendix at appendix one, two, three, the patentee sets forward the two inventive approaches.

[00:31:14] Speaker 00:
Sustain release, one formulation, products, and then two formulation products.

[00:31:20] Speaker 00:
And that's repeated then in the detailed description of the invention.

[00:31:23] Speaker 00:
And then there's a heading at the bottom of Appendix 124.

[00:31:26] Speaker 00:
What's the line that you're reading from?

[00:31:29] Speaker 00:
You said 123?

[00:31:30] Speaker 00:
Yeah, this is an 821 patent, Your Honor.

[00:31:32] Speaker 00:
But this is the same structure of the patent as far as it's drafted with the 023 patent and what was noted in the Watson court decision.

[00:31:40] Speaker 00:
There's a distinction.

[00:31:42] Speaker 00:
They distinguished between single formulation approach and two formulation approach.

[00:31:48] Speaker 00:
And that's picked up in the entirety of the specification.

[00:31:50] Speaker 00:
Starting with the summary of the invention, the detailed description of the invention lays out the two headings there.

[00:31:55] Speaker 00:
You've got sustained release formulation in the 821 patent at appendix 124.

[00:32:03] Speaker 00:
And that goes on for several columns.

[00:32:05] Speaker 00:
And then you get to the description of the patent at column 11, which is the modified release patent product.

[00:32:12] Speaker 00:
And this is the section specification that talks about the two formulation approach, which is what they go ahead and claim.

[00:32:18] Speaker 00:
And as Judge Dyke mentioned in a footnote, or observed in a footnote in the Watson decision, they describe these single formulation products.

[00:32:26] Speaker 00:
They just don't claim them.

[00:32:28] Speaker 00:
Because like you said, Judge Raina, when they get to the claims, they drafted the claims with language that required two portions, two formulations.

[00:32:37] Speaker 00:
They just didn't draft the right claims.

[00:32:41] Speaker 00:
And as Judge Moore mentioned, perhaps they were just late in the game.

[00:32:47] Speaker 00:
And if you look at all of the examples, all of the examples of the two formulation products contain ingredients for an immediate release formulation and a sustained release formulation.

[00:32:58] Speaker 00:
So there are two formulations, not just one set of ingredients that are blended together to produce a single matrix, single formulation product.

[00:33:09] Speaker 00:
Thank you.

[00:33:09] Speaker 00:
Thank you, Your Honor.

[00:33:21] Speaker 04:
A couple of points, Your Honors.

[00:33:24] Speaker 04:
First, Ms.

[00:33:25] Speaker 04:
Hutner said, as I understood it, in response to a 112 rejection in the 032 prosecution, we didn't tell the examiner, look at our sustained release disclosure.

[00:33:36] Speaker 04:
That's not true, Your Honor.

[00:33:38] Speaker 04:
We expressly, in responding to that office action, we expressly pointed the examiner to new disclosure in the 032 specification, particularly paragraph 119,

[00:33:49] Speaker 04:
This is at appendix page 4093.

[00:33:53] Speaker 04:
That's the part that says a sustained release formulation alone can have the claim PK requirements.

[00:33:59] Speaker 04:
And in our remarks at 4697 in response to that, we said, look, the original claims are fully supported, and look at this paragraph of the specification.

[00:34:11] Speaker 04:
So we did do that.

[00:34:13] Speaker 04:
Secondly on that, we did cite to the examiner

[00:34:17] Speaker 04:
The Paragon Court's claim construction for the 252 patent, which had embraced the discrete part of the product construction.

[00:34:25] Speaker 04:
And along with that, we cited to the examiner all of the briefing underlying that.

[00:34:31] Speaker 04:
So the examiner knew what our position was on portions.

[00:34:37] Speaker 04:
The other things I'd like to say about that amendment and that response, we expressly

[00:34:47] Speaker 04:
informed the examiner in a subsequent July 13, 2010 interview and in August 9, 2010 amendment that the claims were not limited to the bilayer tablet or the capsule embodiments that the Watson panel had found.

[00:35:05] Speaker 04:
That's what discrete means.

[00:35:08] Speaker 04:
Other point I wanted to say, Mr. Danyo referred to statements in one of our amendments that

[00:35:16] Speaker 04:
new claims that were added during the O32 prosecution more closely paralleled the 252 claims.

[00:35:23] Speaker 04:
Those statements were not made with respect to the claims that ultimately issued in the O32 patent.

[00:35:28] Speaker 04:
They were made with respect to different claims.

[00:35:31] Speaker 04:
Okay.

[00:35:32] Speaker 04:
Time has expired.

[00:35:33] Speaker 04:
Okay.

[00:35:33] Speaker 04:
Thank you, Your Honor.

[00:35:35] Speaker 04:
We have your argument.

[00:35:36] Speaker 01:
We thank both sides.