[00:00:08] Speaker 04:
Okay, Ms.

[00:00:09] Speaker 04:
Borgman.

[00:00:12] Speaker 00:
Do I have permission to remove my mask?

[00:00:18] Speaker 04:
Yeah, you should take it off.

[00:00:19] Speaker 00:
Thank you, Your Honor.

[00:00:23] Speaker 00:
Good morning, Your Honor.

[00:00:24] Speaker 00:
May it please the court.

[00:00:26] Speaker 00:
There are a variety of issues that are subject of our briefing, but today I'd like to focus on the legal error with respect to the district court's construction of the portion claim terms in the 033 patent, as well as the error associated with the obviousness finding.

[00:00:40] Speaker 00:
So the district court construed the portion terms with an exclusion.

[00:00:44] Speaker 00:
It excludes an ibuprofen core with a promoter gene and outer shell.

[00:00:48] Speaker 00:
The district court's rationale was not based on any finding that there was a disclaimer or disavowal anywhere in the intrinsic record.

[00:00:54] Speaker 00:
It was really based, if we look at the opinion at appendix page 74 to 79, on a finding that the invention was limited to a famotidine core that had a small surface area, that that was the invention, and that the disclosure and the patent specification and the examples of a bilayer

[00:01:12] Speaker 04:
was not part of the invention.

[00:01:14] Speaker 04:
Could the courtroom deputy maybe turn the volume up a little bit on the sound?

[00:01:19] Speaker 04:
Thank you.

[00:01:20] Speaker 04:
Go ahead.

[00:01:21] Speaker 00:
I'm sorry, Your Honor.

[00:01:21] Speaker 00:
Would you like me to try to speak louder?

[00:01:23] Speaker 04:
One or the other.

[00:01:25] Speaker 00:
OK.

[00:01:26] Speaker 00:
All right.

[00:01:26] Speaker 00:
So we submit that this was legal error, because when you look at what the inventors describe in their patent, they clearly describe two embodiments, a phymotidine core embodiment, where the surface area of the core is controlling stability.

[00:01:40] Speaker 00:
But they also clearly demonstrate in the examples another way that you can achieve the claimed stability limitation of less than 1% sulfamide, and that's to the use of a bilayer.

[00:01:48] Speaker 00:
So in that embodiment, the barrier layer that's being placed in the bilayer is what's giving rise to the stability.

[00:01:55] Speaker 00:
So the inventors had described these different embodiments, and they had a right to claim this broadly using broad portion terms that according to their plain and ordinary meaning, so as to encompass both of these embodiments.

[00:02:09] Speaker 02:
You said that you didn't think there was sufficient discussion in the prosecution history to amount to a disclaimer, but that doesn't mean that the discussion is irrelevant.

[00:02:23] Speaker 02:
In other words, the court could rely on those statements, even if it's not a complete disclaimer, to support the view that the specification otherwise only recites one particular form.

[00:02:37] Speaker 00:
Well, I think when you look at the prosecution of the claims that resulted in the 033 patent, what you see is that initially the claims were limited to a famotidine core, with the surface area defined according to the surface area of the core.

[00:02:48] Speaker 02:
You're going to have to speak up.

[00:02:49] Speaker 02:
I really can't hear you.

[00:02:50] Speaker 00:
I'm sorry, Your Honors.

[00:02:51] Speaker 00:
But then what the applicants did was to intentionally, they canceled that claim and intentionally pursued a broader claim scope, where they used the term portion and included dependent claims which encompass these two embodiments, the bilayer tablet as well as the famotidine core.

[00:03:06] Speaker 00:
I think, Judge O'Malley, what you may be referring to is in later prosecution, in the continuation patents, this, in our view, supports a broad construction of portion.

[00:03:15] Speaker 00:
Because in those cases, both the examiner and the applicant presumed that the scope of the invention and the scope of those claims, as originally written, encompassed an ibuprofen core embodiment.

[00:03:26] Speaker 00:
So they had to put into the claim an express proviso, which carved it out from the scope of that claim.

[00:03:33] Speaker 00:
That doesn't operate as a disclaimer.

[00:03:35] Speaker 00:
That is more evidence that the term portion, as it's used in the 033 patent claims, must be construed according to its broad plain and ordinary meaning.

[00:03:43] Speaker 00:
And in this case, the party's experts agreed that there was a plain and ordinary meaning associated with the term portion.

[00:03:50] Speaker 00:
And the district court erred because the district court never made any findings concerning what was the plain and ordinary meaning of portion, and instead focused exclusively on the specification

[00:03:59] Speaker 00:
in order to support the claim construction binding, but also ignored the clear broadening amendment in the prosecution of the claims that resulted in the 033 patent, which would have clearly put the public on notice that the inventors were intending portion to have its broad meaning.

[00:04:15] Speaker 00:
That's why there are dependent claims that go to these different embodiments.

[00:04:18] Speaker 00:
So we submit that there's absolutely nothing.

[00:04:20] Speaker 02:
What in the written description would support an alternative embodiment?

[00:04:24] Speaker 00:
Well, if you look at the examples, in example three, and specifically in table three,

[00:04:30] Speaker 00:
there is disclosure of a multi-particulate, which in column four, lines 37 to 42, the inventors clearly describe as an alternative embodiment that's outside the scope of the claims.

[00:04:41] Speaker 00:
But in the examples, they- Where did they do that?

[00:04:44] Speaker 00:
In column four, lines 37 to 42.

[00:04:49] Speaker 00:
And when you look at the examples, what you see is that that multi-particulate embodiment performed particularly badly.

[00:04:56] Speaker 00:
Because the target that they were shooting for was less than 1% sulfamide.

[00:05:00] Speaker 00:
The multi-particulate produced 3.55%.

[00:05:03] Speaker 00:
But each of the other embodiments, the bilayer and the tablet and tablet with the famotidine core, were able to achieve that low level of sulfamide.

[00:05:11] Speaker 00:
And there's nothing in the patent specification that indicates that the inventors did not consider the bilayer tablet to be part of the invention.

[00:05:18] Speaker 00:
There's a statement where they clearly say that the tablet and tablet with the famotidine core produced better results.

[00:05:23] Speaker 00:
And you can see that in the data.

[00:05:25] Speaker 04:
You're referring here to example three.

[00:05:28] Speaker 04:
You're suggesting example three is within the scope of the claim.

[00:05:32] Speaker 00:
Example three, and specifically the bilayer formulation is described in example three, is within the scope of the claims.

[00:05:40] Speaker 04:
It seems to be comparing the present invention to table three, which is prior art, and saying the invention is superior.

[00:05:52] Speaker 00:
Well, the data for all of the embodiments is in Table 3, and the statement in the text of Example 3 isn't comparing, it's not characterizing the bilayer as prior art.

[00:06:01] Speaker 04:
It says, surprisingly, a tablet and tablet formulation in accordance with the present invention exhibited remarkably improved stability as shown by Table 3 as compared to, and then describing what was in the prior art, right?

[00:06:15] Speaker 00:
That's correct, Your Honor, but we submit that that statement can't be read as a disclaimer of a bilayer tablet.

[00:06:21] Speaker 04:
The fact that they... You keep talking about disclaimer.

[00:06:24] Speaker 04:
We're talking about interpreting claim terms in the light of the specification, which Phillips says is appropriate.

[00:06:30] Speaker 04:
You don't look at the specification just to find disclaimers.

[00:06:35] Speaker 04:
You look at the specification to find definition of terms.

[00:06:39] Speaker 04:
So that's what we're talking about.

[00:06:41] Speaker 00:
Well, I think the specification is just one part of the intrinsic records.

[00:06:45] Speaker 00:
You have a plain and ordinary meaning, which is broad.

[00:06:47] Speaker 00:
You have a specification which provides disclosure of a bilayer tablet.

[00:06:51] Speaker 00:
And then you have the prosecution history, where the applicants clearly were intending to cover that bilayer tablet as part of their invention.

[00:06:59] Speaker 00:
So if we are focused on what's the public notice, the public was clearly on notice.

[00:07:03] Speaker 00:
when they made this broadening amendment and chose to use the term portion that they were intended to claim.

[00:07:08] Speaker 03:
I'm sorry, I don't understand how when you have the sentence that Judge Dyke just read to you that you would claim that the present invention includes the bilayer formulation when it compares the present invention's success to both the multi-particulate and the bilayer formation results.

[00:07:29] Speaker 00:
How do you read that sentence?

[00:07:31] Speaker 00:
What it says is that it's a tablet and tablet in accordance with the invention.

[00:07:35] Speaker 00:
It doesn't say that it is the invention.

[00:07:36] Speaker 00:
It just says it's part of the invention.

[00:07:38] Speaker 00:
And it's touting the benefit of that impurity profile, which if you look at the tablet and tablet with the barrier coating, the amount is zero.

[00:07:46] Speaker 00:
So that is a significant improvement over 0.91.

[00:07:50] Speaker 00:
But that isn't a statement that the bilayer is outside the scope of the invention.

[00:07:55] Speaker 04:
Even in the abstract here,

[00:07:58] Speaker 04:
the invention is stated as the ibuprofen being the outer layer and the fumididide being the inner core.

[00:08:09] Speaker 04:
I mean, it says the compositions comprise the fumididide core having a reduced or minimal surface area surrounded by a layer of ibuprofen.

[00:08:20] Speaker 00:
I agree, Your Honor, but the abstract doesn't define that that is the sum total of the invention.

[00:08:26] Speaker 00:
It's just stating what is just, you know,

[00:08:28] Speaker 00:
it's describing compositions that are disclosed in the specification.

[00:08:32] Speaker 00:
But in addition to a fomotorine core, there's also disclosure of a bilayer tablet.

[00:08:37] Speaker 00:
And the claim limitation for the sulfamide is set at no more than 1%.

[00:08:41] Speaker 00:
And that clearly encompasses the 0.91 result that's obtained for the bilayer tablet.

[00:08:46] Speaker 00:
So we submit, when you look at the specification, and particularly in light of the plain and ordinary meaning, is there anything in the actual claim language that calls out a bilayer formulation?

[00:08:56] Speaker 00:
If you look at the dependent claims, Your Honor, there are dependent claims in the issue claims, and these were part of what was presented in the broadening amendment.

[00:09:04] Speaker 00:
But if you look at claims 3, 4, and 8, those are all directed to a composition that has a portion that comprises a layer of fumotidine beads.

[00:09:14] Speaker 00:
And if you look at claim 8, this is where it specifically focuses on this bilayer tablet where you have a barrier layer in between the two layers.

[00:09:23] Speaker 03:
So those are... Wait, which did you say focuses on a bilayer?

[00:09:27] Speaker 00:
Claims three, four, and eight.

[00:09:29] Speaker 03:
And eight is the one that... Where do they use the word bilayer formulation in any of those?

[00:09:38] Speaker 00:
The term bilayer doesn't appear, but when you look at the description, it's describing two layers, a layer of famotidine and a layer of ibuprofen, which are separated by a barrier layer.

[00:09:49] Speaker 02:
But all of those relate back to the composition of claim one.

[00:09:53] Speaker 00:
That's correct, Your Honor.

[00:09:54] Speaker 00:
And the composition of claim one just simply requires that all of the famotidine be in the second portion.

[00:10:02] Speaker 00:
The ibuprofen is in a first portion.

[00:10:04] Speaker 00:
And then these dependent claims, claim eight, requires that the famotidine portion be in a layer with a barrier layer.

[00:10:12] Speaker 00:
And then the ibuprofen portion is in a layer.

[00:10:14] Speaker 00:
So that's a bilayer tablet.

[00:10:16] Speaker 00:
So that's clear evidence to a person of ordinary skill in the arts that this term, portion, was intentionally used in its broad sense as sort of an umbrella term to encompass these different embodiments that are described within the specification.

[00:10:30] Speaker 04:
Could we turn to the obviousness issue?

[00:10:33] Speaker 00:
Yes, Your Honor.

[00:10:35] Speaker 00:
So with respect to obviousness, we believe that there's reversible error, there was legal error, because the district court found that the reason for allowance of these claims was the introduction of the sulfamide limitation, no more than 1 percent sulfamide.

[00:10:50] Speaker 00:
So this isn't a minor limitation, this is the basis for allowance.

[00:10:53] Speaker 04:
Well, that may be, but the problem is that there is many evidence that

[00:10:58] Speaker 04:
The Golombic, who was a businessman, suggested that feature of this invention.

[00:11:07] Speaker 04:
In fact, he had no discussions about this invention.

[00:11:10] Speaker 04:
And the fact that he may have had a role in inventing that aspect of it in the prior art doesn't make him an inventor, correct?

[00:11:20] Speaker 00:
Well, so I think there are two issues in obviousness.

[00:11:22] Speaker 00:
And I'll answer your question and then move on to the other issue as well, because I just want to make sure they're understood separately.

[00:11:28] Speaker 00:
But with respect to Mr. Gollumbeck, you're correct.

[00:11:30] Speaker 00:
He was a businessman.

[00:11:31] Speaker 00:
And at the time that this company was formed, there were two men, Dr. Tidmarsh and Mr. Gollumbeck, who sat at a kitchen table and conceived of the subject matter in the 096 publication that Alchem relies on for obviousness.

[00:11:44] Speaker 00:
And it's the only place in the record where the district court found it was disclosure.

[00:11:47] Speaker 00:
of 26.6, so coming to your question.

[00:11:51] Speaker 00:
So the district court found, with respect to the 096, that the two of them together conceived of that subject matter, and that that testimony was corroborated by numerous documents, which are FDA communications, including FDA meeting minutes coming back.

[00:12:05] Speaker 04:
They conceived of the ratio.

[00:12:07] Speaker 04:
And the question is whether Gollumbeck suggested that ratio be used in this invention.

[00:12:17] Speaker 04:
And I don't see any evidence in this record other than perhaps his statements, perhaps even not his statements, suggesting that he contributed that aspect of this invention as opposed to having invented that in the prior art.

[00:12:36] Speaker 00:
Well, so this is all part of, you know, it's the whole notion of joint inventorship.

[00:12:41] Speaker 00:
It's part of the same continuation of invention.

[00:12:44] Speaker 00:
And there's testimony in the record from Dr. Gollum.

[00:12:46] Speaker 04:
But Panou says that the fact that you invented something in the prior art, or even that you explained the prior art,

[00:12:53] Speaker 04:
in connection with this invention is not enough.

[00:12:56] Speaker 04:
You have to have suggested the use of a feature from the prior art of this invention.

[00:13:01] Speaker 04:
Where do we have such evidence with respect to Golembuch in this record?

[00:13:07] Speaker 00:
Well, Mr. Golembuch, he continued to be involved, and he testified that he was aware of the work that Tidmarsh was doing with Jerry Zhu, who developed the composition, that he was not mixed with them.

[00:13:16] Speaker 04:
Where did he suggest using this feature in the present invention?

[00:13:21] Speaker 00:
Well, the whole reason for the need to create this formulation was based on the fact that they had conceived of 800 milligrams, a huge amount of ibuprofen with a small amount of promoter.

[00:13:30] Speaker 04:
But you're not answering my question.

[00:13:33] Speaker 04:
Where does this record show that he suggested the use of that ratio for the present invention?

[00:13:42] Speaker 00:
Because it's all part of the same invention.

[00:13:45] Speaker 04:
Because it existed in the prior art?

[00:13:47] Speaker 00:
That's not enough.

[00:13:48] Speaker 00:
I'm sorry?

[00:13:48] Speaker 04:
Because it existed in the prior art?

[00:13:51] Speaker 04:
and he was responsible for it in the prior.

[00:13:54] Speaker 04:
That's not enough.

[00:13:55] Speaker 00:
Your Honor, the question of inventorship here is all to determine whether the 096 publication is even available as prior art, because the only way it comes in is under 102A if it's by another.

[00:14:04] Speaker 00:
The point here is that it isn't by another.

[00:14:06] Speaker 03:
Sure, but you still have to have evidence showing that this guy was an inventor, and since he wasn't

[00:14:13] Speaker 03:
named on it, you have a pretty high burden, and it can't include just his testimony without corroboration.

[00:14:20] Speaker 03:
So what evidence specifically shows that he invented this?

[00:14:24] Speaker 00:
Well, the evidence is that he conceived of that amount, holding Mr. Tidmarsh, and then Tidmarsh continued to develop the product under the same group of people that were involved.

[00:14:35] Speaker 00:
Mr. Gollenbeck didn't contribute to the stability result, but that's the wrong legal test.

[00:14:39] Speaker 00:
That's following the Levin Test from the Fourth Circuit, where you look at the patentable

[00:14:43] Speaker 00:
The question is did he make some contribution to an element?

[00:14:45] Speaker 03:
So did anybody testify that he played a role in the invention of this patch?

[00:14:51] Speaker 00:
So yes, because his involvement, because at the... Who?

[00:14:55] Speaker 00:
Tid Marsh and Golembich together conceived of it.

[00:14:58] Speaker 03:
But Golembich's not good enough with that independent corroboration.

[00:15:00] Speaker 00:
And it's corroborated by these FDA documents that show that they conceived of it, that they presented to the FDA in an IND application

[00:15:08] Speaker 04:
and that was the genesis... Where did Gollum, himself, even testify that he contributed this feature to the President's bench?

[00:15:14] Speaker 00:
Well, his testimony is that he contributed to the conception of the dose amounts, as in his testimony is... That's not the same thing.

[00:15:20] Speaker 02:
He couldn't even identify what he contributed, right?

[00:15:23] Speaker 02:
He couldn't even identify it.

[00:15:24] Speaker 00:
He was asked whether he understood what... I mean, that's a legal conclusion.

[00:15:28] Speaker 00:
He is a lay person.

[00:15:29] Speaker 00:
He's a businessman.

[00:15:30] Speaker 04:
So you have to look at... Okay, so let's look at his testimony.

[00:15:34] Speaker 04:
Where does he say, I contributed this

[00:15:38] Speaker 04:
ratio from the prior art to this invention.

[00:15:41] Speaker 04:
I don't even forget about corroboration.

[00:15:44] Speaker 04:
I don't even see where he testified.

[00:15:46] Speaker 00:
Because his contribution is the same invention that is described.

[00:15:53] Speaker 00:
Section 102 permits inventors to describe their invention without penitentiary as long as they file the next application within one year.

[00:16:00] Speaker 00:
And it's improper under 102 to use his own prior invention against him.

[00:16:05] Speaker 03:
So your answer is

[00:16:07] Speaker 03:
The evidence that shows he invented something in this invention is that other application.

[00:16:12] Speaker 03:
You don't have anything beyond that.

[00:16:14] Speaker 00:
It is the same... No, no, no.

[00:16:17] Speaker 03:
I understand your argument, but is that what you're pointing to?

[00:16:20] Speaker 03:
You don't have any independent evidence beyond that application to show that he invented something in this invention.

[00:16:26] Speaker 03:
Well, the evidence is just... Can you just answer the question, is there anything more or not?

[00:16:29] Speaker 00:
Well, it is the same conception.

[00:16:32] Speaker 00:
There's not a difference between the first invention and the second.

[00:16:34] Speaker 00:
It's just a continuation.

[00:16:36] Speaker 03:
So I'll take that as a no.

[00:16:37] Speaker 03:
You have no additional evidence in the record to point to beyond that application.

[00:16:42] Speaker 00:
Well, I believe his testimony is that he contributed to the conception of that, which resulted in the invention.

[00:16:48] Speaker 02:
The district court found that testimony not to be credible because he didn't have any details.

[00:16:54] Speaker 02:
He couldn't remember anything.

[00:16:55] Speaker 02:
And you can say he's a businessman all he wants, but you also want him to be an inventor.

[00:16:59] Speaker 02:
So the district court's credibility finding is not something that we would lightly disturb, is it?

[00:17:05] Speaker 00:
Well, the purpose of corroboration is to verify that what this person is saying at the fact witness is true.

[00:17:13] Speaker 00:
And the documents do corroborate.

[00:17:15] Speaker 00:
I mean, the court found that they had generated these documents together.

[00:17:19] Speaker 00:
They submitted them to the FDA.

[00:17:21] Speaker 00:
The FDA meeting minutes confirmed that that information was submitted and discussed and clarified at the meeting.

[00:17:27] Speaker 00:
So to the extent there's a question about credibility, the corroborating documents, which should be evaluated under a rule of reason analysis, under the circumstances where there are only two people involved in the conception at this point in time, the court found that this was all conducted before either Lee or Jerry Zhu later on were involved.

[00:17:47] Speaker 04:
I couldn't before unless Judge O'Malley or Judge Hughes have other questions about this.

[00:17:53] Speaker 04:
I just want to ask you one or two questions about the 451 because I find your argument baffling.

[00:17:58] Speaker 04:
I mean, yes, comprising allows you to bring in other things other than those specified in the claim.

[00:18:04] Speaker 04:
But as I understand it, the accused product here doesn't include at least some of the ingredients that are specified in the claim of the 451.

[00:18:18] Speaker 04:
So what's the point?

[00:18:21] Speaker 00:
So the big problem with the court's construction in the 451 patent is that it found this very broad disclaimer and essentially said, well, because you went to the patent office... Okay, but I'm asking you a specific question.

[00:18:32] Speaker 04:
Is it not the case that in the accused product it does not have at least some of the ingredients that are in the 451 claim?

[00:18:44] Speaker 00:
So it is true that the accused product has differences from the specific ingredients that are- Well, and so, I mean, that seems to me fatal.

[00:18:53] Speaker 04:
I mean, you can have additional ingredients, but you've got to have at least the ingredients that are in the claim.

[00:18:59] Speaker 00:
Well, I think that it becomes a question of infringement under the doctrine of equivalence.

[00:19:04] Speaker 00:
But because the court found a broad disclaimer of any and all other barrier layers or barrier layer ingredients, that disclaimer

[00:19:13] Speaker 00:
had the effect of precluding any potential argument for equivalence.

[00:19:17] Speaker 00:
And we think on the record, it's improper to find this broad disclaimer when all the applicants did was to go to the patent office and say, we want to focus on this barrier layer.

[00:19:26] Speaker 00:
And during prosecution, all they did was to say, our invention is this barrier layer, and the prior art doesn't teach or suggest it.

[00:19:33] Speaker 00:
There's never a place where they actually characterize the invention in a way that's any different than how it was recited in the claim.

[00:19:39] Speaker 00:
So for there to be a broad disclaimer finding, there needs to be some place where they actually characterized the opidry layer in a way that was different than how it was being claimed.

[00:19:50] Speaker 04:
OK.

[00:19:51] Speaker 04:
I think we're out of time.

[00:19:52] Speaker 04:
We'll give you two minutes for a bottle.

[00:19:54] Speaker 00:
Thank you, Your Honors.

[00:19:56] Speaker 04:
Mr. Rackesey, am I pronouncing that correctly?

[00:19:58] Speaker 04:
Rackesey.

[00:19:59] Speaker 04:
Rackesey.

[00:20:00] Speaker 04:
OK.

[00:20:01] Speaker 01:
Thank you.

[00:20:01] Speaker 01:
May it please the court?

[00:20:03] Speaker 01:
I'll address things from the back end.

[00:20:04] Speaker 01:
On the 451, that patent requires HPMC, polysorbate, PEG, and titanium dioxide.

[00:20:12] Speaker 01:
The outcome product doesn't contain a single one of the claimed ingredients.

[00:20:17] Speaker 01:
It does contain ingredients that were specifically disclaimed in prior art references.

[00:20:21] Speaker 01:
polyvinyl alcohol talc, a form of PEG.

[00:20:25] Speaker 01:
Those were in that Ibanez reference and the pro reference that were disclaimed.

[00:20:29] Speaker 01:
So it doesn't matter on the scope of the disclaimer here, but we believe there was a clear textbook prosecution disclaimer when the claims are rejected over a reference that has the exact same barrier layer in the claim and ingredients.

[00:20:45] Speaker 01:
And Horizon tells or the applicant tells the office that we're distinguishable because there's one more ingredient.

[00:20:52] Speaker 01:
in that barrier layer and is not simply open dry white, they're telling the world that they are claiming only those ingredients and no others, and they shouldn't be able to recapture that scope now.

[00:21:04] Speaker 01:
On the obviousness moving forward, they've got two problems on obviousness on this inventorship issue.

[00:21:12] Speaker 01:
The first one is Golembich.

[00:21:14] Speaker 01:
who testified himself that he had no scientific development or formulation involvement whatsoever on the 033 patent invention or duexis, which is a commercial embodiment of the 033.

[00:21:27] Speaker 01:
That was his own testimony.

[00:21:28] Speaker 01:
When asked what he did contribute, he said he couldn't remember

[00:21:31] Speaker 01:
But he had discussions with Tidmarsh.

[00:21:34] Speaker 01:
As the court said, that's nonspecific, that's not convincing, it's not credible, and it's not corroborated.

[00:21:41] Speaker 01:
Not a single document of corroboration here.

[00:21:44] Speaker 01:
And context and corroboration matters.

[00:21:46] Speaker 01:
You're talking about an interested witness, still works for the company for $30,000 a month.

[00:21:51] Speaker 01:
For 13 years, he doesn't come forward.

[00:21:54] Speaker 01:
Two months of litigation, he doesn't come forward.

[00:21:56] Speaker 01:
On the eve of trial for the first time, now they're claiming he's an inventor because they want to knock out a piece of prior art.

[00:22:02] Speaker 01:
That makes corroboration key.

[00:22:04] Speaker 01:
And there's not a single corroborating document, not a lab notebook, not a invention disclosure, not on the back of a napkin saying he contributed anything to the 033.

[00:22:14] Speaker 01:
Those fact findings we believe are not error, much less clear error.

[00:22:18] Speaker 01:
They were compelled by the record.

[00:22:20] Speaker 01:
And because of that alone, the 096 is the work of another.

[00:22:24] Speaker 01:
But they don't challenge, secondly, Dr. Zhu.

[00:22:28] Speaker 01:
Complete silence on Dr. Zhu in their papers or their briefs to this court.

[00:22:33] Speaker 01:
The district court found Dr. Zhu had a significant contribution to the only thing that the 033 patent is about, which is a stable composition with that tablet architecture.

[00:22:43] Speaker 01:
the surface area and those stability limitations.

[00:22:46] Speaker 01:
The court found as a matter of fact that that was Zoo's contribution and they don't challenge those fact findings.

[00:22:52] Speaker 01:
So even regardless of Mr. Golumbick, Zoo again makes different inventive entities and makes the 096 the work of another.

[00:23:00] Speaker 01:
So the 096 is in the case as prior art we submit under those fact findings either way.

[00:23:07] Speaker 01:
And with the 096, they don't even press an obviousness argument regarding fomotidine and its dosing.

[00:23:14] Speaker 01:
But even if we throw out the 096, they have problems because

[00:23:18] Speaker 01:
The district court, again, made a number of fact findings that they don't even challenge on appeal.

[00:23:23] Speaker 01:
The district court said the invention was obvious over Taha and or the 096, not both.

[00:23:29] Speaker 01:
And he then went on to make a series of specific findings that it was obvious to use the three times daily ibuprofen, 800 milligrams, that it was obvious to put them together, that Taha taught you, you could successfully use modenine twice daily at the same dose, 80 milligrams in the claims.

[00:23:47] Speaker 01:
He went on to say that you could marry those intervals precisely because of the PK characteristics of famotidine.

[00:23:56] Speaker 01:
It was shown in the art to be used three times daily and to have linear PK.

[00:24:00] Speaker 01:
And FDA had already approved famotidine for once, twice, and four times daily.

[00:24:04] Speaker 01:
And beyond that, Horizon doesn't challenge any of the testimony or evidence in the district court from Dr. Barnett and Dr. Chambliss, both of whom the court credited.

[00:24:13] Speaker 01:
And Dr. Barnett specifically testified.

[00:24:16] Speaker 01:
Taha tells you you can use it twice a day at the claimed dose, and the other prior tells you you can use it at three times a day at the claimed dose, such as the edge reference.

[00:24:25] Speaker 01:
So we submit there's no great leap here that it's obvious, regardless of whether the 096 is in the case or not.

[00:24:32] Speaker 01:
Third, for reasons still not clear to me, they conceded in the district court and before this court that even if the 096 is not technically art, they say it's still relevant to reasonable expectation of success.

[00:24:46] Speaker 01:
And that completely defeats their appeal here on obviousness, because if it's relevant to reasonable expectation of success,

[00:24:54] Speaker 01:
meaning it informs the knowledge of the skilled person, then in addition to Taha and all those fact findings they don't challenge, showing it was motivation and reasonable expectation of success for promoting three times daily, then the skilled person would also know that someone had already suggested these actives together at those strengths three times daily.

[00:25:14] Speaker 01:
So obvious with or without the 096.

[00:25:18] Speaker 01:
On clean construction and infringement

[00:25:22] Speaker 01:
This specification repeatedly and unequivocally describes the pharmaceutical compositions of the present invention, or as it says, the claimed feature of the invention as a

[00:25:34] Speaker 01:
dosage form with a fomotanine compartment structured as a core and a ibuprofen compartment structured as a surrounding ibuprofen portion.

[00:25:44] Speaker 01:
We see that in the abstract.

[00:25:46] Speaker 01:
We see that in the summary of the invention.

[00:25:47] Speaker 01:
We see that in the detailed description where they talk about this supposed discovery that you can increase stability by reducing the surface area of contact.

[00:25:57] Speaker 01:
And it says, the way you do that is you use the design of the present invention, which they call the Phamonidine core.

[00:26:04] Speaker 01:
You manipulate that core with its geometry, its shape and size.

[00:26:07] Speaker 01:
You make it small.

[00:26:08] Speaker 01:
You get the surface area below Formula One.

[00:26:11] Speaker 01:
And that's the invention.

[00:26:13] Speaker 01:
That's all over the summary of the invention and the detailed description.

[00:26:17] Speaker 01:
There are no other embodiments in this patent.

[00:26:20] Speaker 01:
None.

[00:26:21] Speaker 01:
Every time they're talking about different aspects or different embodiments, they're talking about variations on that same the Modadine core design.

[00:26:29] Speaker 01:
They're never talking about a different embodiment.

[00:26:32] Speaker 01:
So it's not a case of reading out embodiments or saying that a single embodiment means that limits the claims.

[00:26:39] Speaker 01:
There is only one.

[00:26:40] Speaker 01:
invention here, and that's the Fomotanine core design.

[00:26:44] Speaker 01:
Regarding this whole bilayer tablet issue, I think it's undisputed and the district court recognized this.

[00:26:51] Speaker 01:
It doesn't even show up in the intrinsic record at all until example three.

[00:26:57] Speaker 01:
Up until example three, every mention is about that Fomotanine core design and how if you use that and you control the geometry, you can then omit the barrier layer without sacrificing stability.

[00:27:08] Speaker 03:
What do you think the difference between claim five and claim eight is then if everything in here is a core shell?

[00:27:17] Speaker 01:
Well, Your Honor, I think it's important.

[00:27:19] Speaker 01:
I think that's a great question.

[00:27:21] Speaker 01:
It's important to not use the term bilayer loosely, because bilayer is used in this record in a couple of different ways.

[00:27:30] Speaker 01:
One way is you see an example three, where you're basically taking, imagine a sandwich, a layer of thymodidine, a layer of ibuprofen, barrier layer, and you're sandwiching them together.

[00:27:40] Speaker 01:
So you have a huge surface area, obviously, of the famotidine.

[00:27:44] Speaker 01:
So nothing like the invention.

[00:27:46] Speaker 01:
You're not using geometry to reduce that surface area.

[00:27:49] Speaker 01:
That's the bilayer tablet that they tested in example three.

[00:27:53] Speaker 01:
And they found that the invention, the tablet with the famotidine core, showed remarkable stability versus that bilayer.

[00:28:00] Speaker 01:
So that's the bilayer they're referring to in example three, in which we believe the district court rightly said was not part of the invention.

[00:28:07] Speaker 01:
Bilayer is also used in other parts of the record, such in the prior art.

[00:28:12] Speaker 01:
One of the publications that was used in the obviousness finding, the 876 publication, that uses bilayer terminology where you're taking an acid labile core.

[00:28:24] Speaker 01:
So imagine like famotidine or an acid labile active ingredient.

[00:28:27] Speaker 01:
You put it in a small core, you put a barrier layer around it, and then you put one layer

[00:28:33] Speaker 01:
uh, around it on the side, that's referred to as a bilayer configuration.

[00:28:38] Speaker 01:
And there's a second one in the eight seven six, it's figures one and two.

[00:28:42] Speaker 01:
And Dr. Chan was testified about how those could also be referred to as bilayers.

[00:28:47] Speaker 01:
And the district court said that was an obvious variation on the Pomona Dean core invention here, precisely because the eight seven six publication is still using that small.

[00:28:58] Speaker 03:
I'd like to go on, but you're either too far in the weeds for me or you're not answering my question.

[00:29:03] Speaker 03:
Claim 5 specifically talks about the famotidine core, the ibuprofen layer, and the core is surrounded by a barrier, right?

[00:29:14] Speaker 01:
Claim 5, Your Honor?

[00:29:16] Speaker 01:
Claim 5 actually uses portion

[00:29:18] Speaker 01:
interchangeably with compartments.

[00:29:21] Speaker 01:
Compartments are defined terms to mean the formodating core and the surrounding ibuprofen.

[00:29:27] Speaker 03:
Sorry, let me just pull it up to make sure I'm not using the wrong words either.

[00:29:30] Speaker 01:
Sure.

[00:29:35] Speaker 03:
It's composition of claim one where the second portion is a core, the first portion is a shell, the surrounds it, and there's a barrier layer.

[00:29:45] Speaker 03:
That's kind of

[00:29:47] Speaker 03:
That's what it does.

[00:29:48] Speaker 03:
So basically, instead of just having geometry, it also has the barrier layer to protect the core.

[00:29:54] Speaker 01:
Yeah, the barrier layer is optional.

[00:29:56] Speaker 03:
I guess what I'm asking is, if everything here is about a core shell composition, which is the claim construction essentially, I think, why isn't 8 duplicative of 5?

[00:30:09] Speaker 03:
Because it has

[00:30:11] Speaker 03:
a second portion, a first portion, and the layers are surrounded by a barrier, if we're interpreting it all?

[00:30:19] Speaker 01:
No, Your Honor.

[00:30:20] Speaker 01:
I don't believe you are, because portions is referring to the compartments.

[00:30:24] Speaker 01:
So that's the commodity in core.

[00:30:26] Speaker 01:
So can you tell me what claim eight looks like then?

[00:30:30] Speaker 01:
Claim eight would still, claim eight would be what I was trying to refer to in the eight, seven, six publication.

[00:30:34] Speaker 01:
You would still have a core.

[00:30:36] Speaker 01:
You would still have a famotidine core.

[00:30:38] Speaker 01:
That's the invention, the only thing described to the invention.

[00:30:41] Speaker 01:
And then you could have a layer of, you could have a barrier layer.

[00:30:46] Speaker 01:
Then you could have a layer of ibuprofen, which may or may not go all the way around it.

[00:30:52] Speaker 01:
So that's not referring to the bilayer comparator, I'll call it, in the example three.

[00:30:59] Speaker 02:
How is the proposed, your standard product, your proposed product, how does it achieve stability?

[00:31:08] Speaker 01:
The ALKOM product achieves stability via a barrier layer.

[00:31:12] Speaker 01:
So it, and this was the subject of Dr. Chambliss' testimony and the fact findings, ALKOM has a huge, comparatively, ibuprofen core.

[00:31:22] Speaker 01:
It is, by mass quantity, it's 30 times larger than a promoting core.

[00:31:27] Speaker 01:
And the record you can find in surface area, I believe it's 518 square millimeters of surface area of contact.

[00:31:35] Speaker 01:
And so it's huge.

[00:31:36] Speaker 01:
So it can't take advantage of the geometry.

[00:31:40] Speaker 01:
Even the inventor, Tidmarsh, testified that an ibuprofen core just won't work in the context of this invention.

[00:31:48] Speaker 01:
Formula one doesn't apply to it.

[00:31:50] Speaker 01:
And I believe he testified you can't use the geometry or surface area alone to stabilize it.

[00:31:56] Speaker 01:
because it won't work, and he testified you have to stabilize it a different way.

[00:32:00] Speaker 01:
And so, ALKOM uses a barrier layer, and they have to use a barrier layer to make it stable because of the incompatibility of these ingredients.

[00:32:08] Speaker 01:
That's what Dr. Chan was testing.

[00:32:09] Speaker 02:
And its barrier layer is just not Opry-D-White, right?

[00:32:14] Speaker 01:
Correct.

[00:32:15] Speaker 01:
The ALKOM barrier layer is polyvinyl alcohol talc and

[00:32:22] Speaker 01:
I said it earlier, and now it's escaping.

[00:32:25] Speaker 01:
But it's three different ingredients.

[00:32:27] Speaker 01:
It's none of the ingredients in the 451 patent.

[00:32:30] Speaker 01:
It's actually the ingredients from one of those disclaimed, or a couple of those disclaimed prior art references.

[00:32:36] Speaker 01:
But that's how it stabilized.

[00:32:38] Speaker 01:
And that was one of the major grounds of the district court's DOE

[00:32:42] Speaker 01:
analysis when he actually delved into the two tests, the insubstantial differences in the function way result, he made that finding that the burial error was a substantially different way of stabilizing the product.

[00:32:56] Speaker 01:
And we submit that can't be error, much less clear error.

[00:32:59] Speaker 01:
But before we even get there, I think it's important to note that district court was correct to head off this DOE theory at the pass as insufficient as a matter of law.

[00:33:08] Speaker 01:
because they admittedly, excuse me, Horizon admittedly applied it to more than one limitation at the same time in violation of the Warner Jenkinson limitation by limitation.

[00:33:20] Speaker 02:
We don't necessarily even have to agree with that given that the court made alternative findings, right?

[00:33:25] Speaker 01:
Correct, Your Honor.

[00:33:26] Speaker 01:
We believe the alternative findings are not only, they're not clear error, but they are compelled by the evidence.

[00:33:32] Speaker 01:
But as an alternative, he found they didn't even apply a correct analysis by mishmashing the elements together.

[00:33:39] Speaker 01:
Their theory was if you separate it and it's stable, you infringe.

[00:33:43] Speaker 01:
There was no attempt to put linking argument or particularized testimony that an ibuprofen compartment that's not a core

[00:33:50] Speaker 01:
or that is a shell is somehow equivalent to a fumotidine core.

[00:33:54] Speaker 01:
There's no attempt to do that.

[00:33:55] Speaker 01:
They assign the same function to everything.

[00:33:57] Speaker 01:
They said you just take the portions, separate them, and stable product, and you infringe.

[00:34:03] Speaker 01:
We submit that was an improper DOE analysis.

[00:34:06] Speaker 01:
It doesn't go element by element.

[00:34:08] Speaker 01:
It looks at the product as a whole.

[00:34:10] Speaker 01:
But you are correct, Your Honor.

[00:34:11] Speaker 01:
The fact findings, we believe, stand

[00:34:14] Speaker 01:
the district court's analysis was thorough, detailed, and we believe absolutely correct.

[00:34:20] Speaker 01:
So if there are any other questions, I will yield the few seconds I have left.

[00:34:28] Speaker 04:
Thank you, Your Honor.

[00:34:42] Speaker 00:
Your Honor,

[00:34:44] Speaker 00:
Outcomes Council argues that Taha discloses the 26.6 milligram three times a day.

[00:34:49] Speaker 00:
The district court expressly found that it didn't at the APPX 155.

[00:34:54] Speaker 00:
It was only the 096 publication that made that disclosure.

[00:34:57] Speaker 00:
And Outcomes Council also suggests that we don't challenge any of the district court's findings on obviousness aside from this question about the 096 publication being available as prior art.

[00:35:09] Speaker 00:
That's also not true.

[00:35:10] Speaker 00:
In our briefing, we also make the argument that

[00:35:13] Speaker 00:
that this very limitation that resulted in allowance of the claims less than 1% sulfamide is a limitation that ALCHEM had the high burden of proof to establish by clear and convincing evidence that there was a reasonable expectation of success.

[00:35:25] Speaker 00:
Alchem presented no evidence at trial through its expert of anything to do with a reasonable expectation of success, specifically with respect to sulfamide and specifically with respect to less than 1%.

[00:35:35] Speaker 00:
And so the district court's opinion, if you look at APPX 156 to 164, doesn't rely on any fact finding based on Alchem's testimony.

[00:35:45] Speaker 00:
What the district court did was to improperly shift the burden to horizon.

[00:35:48] Speaker 00:
And that whole section of the opinion is all about what Horizon failed to prove as opposed to what Al can prove.

[00:35:55] Speaker 00:
So there's legal error because Al can board the burden of proof on that issue.

[00:35:59] Speaker 00:
It failed to provide any evidence.

[00:36:01] Speaker 00:
And then there's further error because the district court, in the absence of any evidence to support the expectation of success, then attempted to fill in the gaps with its own assessment of how a person of skill in the art would evaluate the prior art.

[00:36:13] Speaker 00:
And the court found that a person of skill in the art would have at least a bachelor's degree in chemistry or related field, plus multiple years of experience.

[00:36:21] Speaker 00:
The district court is not a person of skill in the art.

[00:36:24] Speaker 00:
And both parties relied on experts to provide testimony about how a person of skill in the art would interpret these references.

[00:36:30] Speaker 00:
So there's further legal error because there's just no basis to find any reasonable expectation of success with respect to the key limitation that result in allowance of the patent.

[00:36:39] Speaker 00:
So we submit that that's a separate error from this question about whether the 096 patent is available as prior art.

[00:36:45] Speaker 00:
That error exists with or without the 096 publication.

[00:36:51] Speaker 04:
I think we're out of time.

[00:36:53] Speaker 04:
Thank you.

[00:36:54] Speaker 04:
Thank you, Your Honor.

[00:36:54] Speaker 04:
I thank both counsels.

[00:36:55] Speaker 04:
The case is submitted.