[00:00:24] Speaker 04:
Our next case is Farron Pharmaceuticals, Inc.

[00:00:27] Speaker 04:
versus Parr Pharmaceutical, Inc., 17-2399.

[00:00:42] Speaker 04:
Mr. Berman, you've reserved three minutes of time for rebuttal.

[00:00:46] Speaker 04:
That's correct.

[00:00:46] Speaker 04:
All right, so you may proceed.

[00:00:59] Speaker 01:
Good morning to the panel.

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

[00:01:01] Speaker 01:
There are two independent reasons why PAR does not infringe Ferring's patents.

[00:01:07] Speaker 01:
First, under the proper claim construction, PAR's product does not have a layer of sodium picosulfate coating the core.

[00:01:16] Speaker 01:
Second, as the ANDA makes clear, PAR does not spray coat.

[00:01:21] Speaker 01:
Instead, PAR wet granulates its product.

[00:01:24] Speaker 01:
The district court's claim construction was erroneous.

[00:01:27] Speaker 00:
Based on the intrinsic evidence, which this court considers to know though, the claims require... Mr. Berman, let me just ask you, if one accepts the district court's claim construction on coding or layer, I understand you do not dispute that your product meets that limitation as so construed.

[00:01:51] Speaker 01:
That is correct.

[00:01:52] Speaker 01:
That we do not dispute that, that there is the independent reason for non-infringement that part is not spray coat.

[00:01:59] Speaker 01:
Oh, that I understand.

[00:02:00] Speaker 01:
That I understand.

[00:02:02] Speaker 01:
Yeah.

[00:02:02] Speaker 01:
So the key pieces of intrinsic evidence supporting the construction that the claims require the picosulfate layer to substantially evenly surround the core are first, the inventor Dow's declaration

[00:02:17] Speaker 01:
showing that the preferred embodiment solved the prior art problem.

[00:02:22] Speaker 01:
Second, the patent amendments where the inventors disavowed broader coverage and limited their claims to this preferred embodiment.

[00:02:32] Speaker 01:
Third, the photos of the granules in the original specification describing a thin layer of picosulfate surrounding the core.

[00:02:42] Speaker 01:
And fourth,

[00:02:43] Speaker 01:
the examiner's reasons for allowance saying why the preferred embodiment was patentable over the prior art.

[00:02:49] Speaker 01:
So since the inventors restricted their invention to this preferred embodiment and disclaimed broader coverage, that is what the claim should cover.

[00:02:58] Speaker 01:
It's quite simple.

[00:03:01] Speaker 01:
Second, PAR does not employ spray coating.

[00:03:03] Speaker 01:
PARWET granulates its product.

[00:03:06] Speaker 01:
Under this court's Abbott v. Torr farm case, PAR's numerous ANTA statements

[00:03:12] Speaker 01:
that it wet granulates control the infringement inquiry.

[00:03:16] Speaker 01:
And this court has never held that an expert's unsubstantiated assertions based on nothing more than his interpretation of the ANDA and unmoored to any objective industry standards were sufficient to overcome the ANDA statements.

[00:03:38] Speaker 01:
Instead, this court has always required hard evidence

[00:03:42] Speaker 01:
like testing PARS process to overcome the ANDA.

[00:03:47] Speaker 01:
Here, Ferring's expert failed to conduct any testing or even compare PARS process to a reference standard.

[00:03:55] Speaker 02:
Isn't it true that the same equipment is used whether you are using wet granulation or spray coating?

[00:04:06] Speaker 01:
It is undisputed that the same equipment can be used for both, typically

[00:04:12] Speaker 01:
when a top spray configuration is done, which is what has been used here, it is made to wet granulate.

[00:04:23] Speaker 01:
The specifications for top spray are wet granulation.

[00:04:28] Speaker 01:
When it's bottom spray configured with the sprayer at the bottom, that configuration is specifically to spray coat.

[00:04:36] Speaker 01:
So while the same equipment can be used for both,

[00:04:39] Speaker 01:
Typically, there are, of course, outlier instances where they are reversed and used for unconventional settings.

[00:04:51] Speaker 01:
But under the conventional settings, which are used, top spray is wet granulation.

[00:04:57] Speaker 02:
So here, it's very- Your position here is that the district court clearly erred in relying on Dr. Debe's testimony.

[00:05:08] Speaker 01:
No, well, it's Dr. Johnson's testimony for the spray coating issue.

[00:05:16] Speaker 01:
And it's not a credibility issue.

[00:05:20] Speaker 01:
The issue is one of sufficiency of the evidence.

[00:05:23] Speaker 01:
You have an expert who just looked at the ANDA and speculated he never conducted any testing or never even compared PAR's process to any, not a single,

[00:05:37] Speaker 01:
piece of literature over the countless decades of literature that have amassed on spray coating and wet granulation, not a single citation to any literature, just absolute unmoored speculation.

[00:05:54] Speaker 01:
And that is insufficient basis under Abbott v Torfarm for faring to carry its burden of persuasion.

[00:06:02] Speaker 01:
This court is very clear there have been

[00:06:06] Speaker 01:
over 30 cases that have cited Abbott v. Torrfarm.

[00:06:11] Speaker 01:
Many have been cited in this court.

[00:06:14] Speaker 01:
And it is a constant that the district court holds.

[00:06:21] Speaker 01:
When the district court holds that unsubstantiated assertions may tip the scale, this court has reversed.

[00:06:29] Speaker 01:
In the Alcon, I'm sorry, in the Brahmanidine patent litigation case,

[00:06:35] Speaker 01:
This court reversed the district court, and that's 643 F.

[00:06:38] Speaker 01:
3rd, 1366.

[00:06:42] Speaker 01:
This court reversed the district court holding because it was based on unsupported expert testimony.

[00:06:48] Speaker 01:
In this court's Baer v. Ewan case from 2000, which is in our brief, the court affirmed the district court's holding that unsubstantiated assertions do not overcome the end of statements.

[00:07:03] Speaker 01:
So the district court wrongly found

[00:07:05] Speaker 01:
that par spray coats, and this court should reverse that determination.

[00:07:11] Speaker 04:
Wasn't that decision mainly based on credibility of the experts?

[00:07:17] Speaker 04:
It's a credibility judgment more than anything.

[00:07:20] Speaker 01:
Well, what the case law is very clear on is that when you have objective evidence,

[00:07:31] Speaker 01:
There is not a credibility determination among the experts if you were ignoring that independent objective evidence.

[00:07:43] Speaker 01:
And that's the Bear v. Watson case.

[00:07:46] Speaker 04:
Not the Bear v. Watson.

[00:07:47] Speaker 04:
The district court seems to have found the testimony of Farin's expert, Dr. Johnson, more credible than your expert.

[00:07:53] Speaker 01:
But like I said, this is not an issue of credibility.

[00:07:57] Speaker 01:
Even if you believe every single thing that Dr. Johnson says, under this court's abit vitur farm and its progeny, which there are numerous of, just unmoored speculative statements, just looking at the ANDA and testifying about it, has been held several times to be not sufficient.

[00:08:18] Speaker 01:
In fact, there's not a single case.

[00:08:20] Speaker 02:
Isn't it true, though?

[00:08:20] Speaker 02:
Don't you agree that the, I understand that

[00:08:23] Speaker 02:
the best evidence of what process PAR used comes from the ANDA itself.

[00:08:28] Speaker 02:
That's your position, right?

[00:08:30] Speaker 01:
That is correct.

[00:08:31] Speaker 02:
So you say it's unmoored, but it was based on the ANDA's description of the process that PAR uses.

[00:08:39] Speaker 01:
PAR consistently and several times throughout the ANDA says they are wet-granulating.

[00:08:46] Speaker 01:
They set the specifications for wet-granulation,

[00:08:49] Speaker 01:
The equipment is set for wet granulation.

[00:08:52] Speaker 02:
Because the label is wet granulation, you think that that comes with a presumption and some sort of testing should have been done.

[00:08:59] Speaker 01:
Do I understand that?

[00:08:59] Speaker 01:
It's not simply a label, Your Honor, with all due respect.

[00:09:03] Speaker 01:
I understand what you're saying.

[00:09:04] Speaker 01:
This is a highly technical term.

[00:09:05] Speaker 02:
Just to interrupt you for a minute.

[00:09:07] Speaker 02:
I just want to know, if Banda characterizes the product in a certain way and uses a particular label,

[00:09:14] Speaker 02:
Does that create some sort of evidentiary presumption that that label is properly used?

[00:09:20] Speaker 01:
I don't think your situation applies here, because here it is not a label.

[00:09:27] Speaker 01:
This is a very technical term, wet granulation, that has been understood for decades to mean a certain technology.

[00:09:34] Speaker 01:
Spray coding is over here as a completely separate technology.

[00:09:38] Speaker 02:
The problem I have is I'm an appellate judge, and my job is to look for clear error.

[00:09:44] Speaker 02:
And what you're saying is, as I understand it, is that I should look at the facts where two sophisticated parties with two able, sophisticated experts are presenting two different interpretations of what that process is.

[00:09:59] Speaker 02:
And you're saying that yours is correct and characterizing the other one as being unmoored.

[00:10:07] Speaker 02:
But I look at the other one, and there's pages and pages of testimony and explanations

[00:10:13] Speaker 02:
for why it is the appropriate understanding.

[00:10:16] Speaker 02:
So maybe you need to dig into a little bit more detail on why you think that the contrary expert testimony is unmoored.

[00:10:24] Speaker 01:
Because there is not a single objective evidence saying why what he's saying is at all credible with regard to the technology.

[00:10:35] Speaker 01:
He does not say, for example, when he says there's a six degree temperature drop, therefore,

[00:10:41] Speaker 01:
It's clearly spray coating.

[00:10:44] Speaker 01:
Why?

[00:10:44] Speaker 01:
Show me a reference that says that.

[00:10:48] Speaker 01:
Then I might believe you, and I might be able to rebut that.

[00:10:51] Speaker 01:
But simply testifying, putting your finger in the wind and saying six degrees means spray coating does not tell me why.

[00:10:59] Speaker 01:
Why not five?

[00:11:00] Speaker 01:
What about seven?

[00:11:02] Speaker 01:
It's unhinged.

[00:11:05] Speaker 01:
So getting back to the construction, which this court reviews de novo,

[00:11:11] Speaker 01:
The four pieces of intrinsic evidence, the JAL declaration, the patent amendments, and well, two of those, the JAL declaration and the patent amendments, which go hand in hand, that is a clear disavowal of coverage.

[00:11:26] Speaker 01:
You have the patent applicant saying, here is what I invented.

[00:11:33] Speaker 01:
The spray-coated layer, which is shown, for example, in the JAL declaration figure two,

[00:11:40] Speaker 01:
And here is how my invention solved the prior art problem with the Pekalax product.

[00:11:46] Speaker 01:
And that's shown in figure one of the declaration and discussed in paragraph seven.

[00:11:51] Speaker 01:
So it's similar to the Hockerson Halberstadt case that is cited by Ferring.

[00:11:58] Speaker 01:
The inventor drawing submitted in prosecution limits the claims.

[00:12:05] Speaker 01:
And the exact same thing happened in the Hockerson Halberstadt case.

[00:12:09] Speaker 01:
And this court found that that drawing submitted in prosecution did limit the scope of the claims.

[00:12:17] Speaker 01:
Same situation here.

[00:12:19] Speaker 01:
You have the amendment where the patent applicants told the Patent Office that they were claiming this preferred embodiment to overcome the prior ARC PECAL Act's product, their own product.

[00:12:32] Speaker 01:
So this is a extremely narrow

[00:12:35] Speaker 01:
invention.

[00:12:37] Speaker 01:
It is a slight improvement, narrowly capturing the inventor's contribution over his prior art process and product.

[00:12:50] Speaker 01:
So that is exactly what the claim should cover.

[00:12:52] Speaker 02:
Are you also maintaining your O2 micro argument?

[00:12:57] Speaker 01:
So procedurally, the court below made several errors which

[00:13:04] Speaker 01:
led to these substantive errors, failing to consider the intrinsic evidence.

[00:13:10] Speaker 01:
O2 micro stands for the proposition that when there is a dispute over claim language, the district court has a duty to resolve that.

[00:13:19] Speaker 01:
And simply saying the plain and ordinary meaning applies when it does not resolve that dispute is not sufficient.

[00:13:27] Speaker 01:
That is, we were

[00:13:28] Speaker 01:
Citing O2 micro as an indicator that this smells funny, the district court did something wrong because the entire argument at Markman was about scope, how much picosulfate coverage is necessary on the court.

[00:13:46] Speaker 01:
And the district court refused to address that despite our several pleas for him to do so.

[00:13:52] Speaker 02:
But you acknowledge, for example, that O2 micro is very different, because this was a bench trial and not a jury trial.

[00:14:00] Speaker 02:
I believe this court does have cases saying that the district court can construe claim terms when it wants to.

[00:14:09] Speaker 02:
Absent an O2 micro problem, where the claim construction is given to the jury and the court doesn't construe the term.

[00:14:17] Speaker 01:
That's true.

[00:14:17] Speaker 01:
And I'm in my rebuttal time, so I'd like to just address your question and sit down.

[00:14:22] Speaker 01:
The problem was not the rolling claim construction.

[00:14:27] Speaker 01:
Absolutely that is fine under this court's precedent.

[00:14:30] Speaker 01:
The problem was when we got to trial, instead of where Phillips says you have to look at the intrinsic evidence in order to determine the plain and ordinary meaning, here the court said you can't look at it.

[00:14:41] Speaker 01:
It was the absolute opposite of Phillips.

[00:14:45] Speaker 01:
It was the pre-Phillips way that this court, once Phillips came out, said you can't do it that way.

[00:14:51] Speaker 01:
That is what the district court did.

[00:14:54] Speaker 01:
And I'll reserve that.

[00:14:54] Speaker 04:
Is that because it had already resolved the dispute?

[00:14:57] Speaker 04:
I mean, why should it revisit a dispute that's already been resolved?

[00:15:01] Speaker 01:
Assigning a term, the plain and ordinary meaning, when the scope of that term has not been resolved, he did not resolve the dispute.

[00:15:11] Speaker 01:
And I thank you.

[00:15:12] Speaker 01:
I'll sit down now and reserve the rest of my time.

[00:15:20] Speaker 04:
OK.

[00:15:20] Speaker 04:
Is that correct?

[00:15:21] Speaker 03:
Burke, actually.

[00:15:23] Speaker 04:
Thank you.

[00:15:24] Speaker 03:
May I please the court?

[00:15:26] Speaker 03:
I'd like to start with the claim construction issue, and I'd like to address basically two issues.

[00:15:34] Speaker 03:
What I didn't hear my learned colleague explain was that the construction that PAR now posits is the substantially evenly surrounding the core for coding and coded and even layer.

[00:15:51] Speaker 03:
And quite frankly, that finds no support in the intrinsic record.

[00:15:55] Speaker 03:
And I can take you through that.

[00:15:57] Speaker 03:
I heard today that we have different intrinsic record evidence that they're relying on.

[00:16:03] Speaker 03:
Quite frankly, this amendment issue appeared for the first time in their gray brief, in their reply brief.

[00:16:08] Speaker 03:
It was never argued below.

[00:16:10] Speaker 03:
And therefore, it should be discounted.

[00:16:13] Speaker 03:
Nevertheless, I can address it substantively if we need to.

[00:16:16] Speaker 03:
The second thing I'd like to address is that,

[00:16:19] Speaker 03:
There were two experts for fairing.

[00:16:21] Speaker 03:
One was Dr. Johnson, who testified about the spray coating.

[00:16:26] Speaker 03:
The other was Dr. Davies, who gave the plain and ordinary meaning for the terms coating and coding as the district court permitted.

[00:16:35] Speaker 03:
And that meaning was a layer of substance on the outer surface of another substance.

[00:16:41] Speaker 03:
And the issue is not quantity.

[00:16:44] Speaker 03:
It was in the Markman hearing.

[00:16:45] Speaker 03:
But through expert discovery and actually at trial,

[00:16:49] Speaker 03:
the issue became location.

[00:16:52] Speaker 03:
Where is it?

[00:16:53] Speaker 03:
It's on the outer surface of the potassium bicarbonate core.

[00:16:56] Speaker 03:
And that's important.

[00:16:58] Speaker 03:
So let's, he, Parse started with the Dow declaration, but I'd sort of like to start with the three pieces of evidence that were argued throughout, from Markman all the way to trial, as somehow limiting the plain and ordinary meaning of the term coded encoding.

[00:17:19] Speaker 03:
It started with a paragraph in the specification in column 9, and that's column 9, lines 62 to 67, where there is language that talks about sprayed very evenly.

[00:17:40] Speaker 03:
There's never been any effort by PAR to explain how sprayed very evenly equates to

[00:17:48] Speaker 03:
substantially evenly surrounding the core.

[00:17:52] Speaker 03:
In fact, this whole dissertation in column nine, it's important for the court to understand.

[00:17:58] Speaker 03:
It's just describing what the improvements were to the process when they moved to spray coating, which eliminated the problem of the prior process, which was lack of homogeneity, both in the intermediate products and in the final product.

[00:18:15] Speaker 03:
And that's explained starting at

[00:18:18] Speaker 03:
column 9, line 30 through 38.

[00:18:20] Speaker 03:
The prior process was a wet mixing process.

[00:18:26] Speaker 03:
That led to two problems.

[00:18:28] Speaker 03:
Because of the wetness of the process, some of the potassium bicarbonate dissolved.

[00:18:33] Speaker 03:
It's a very soluble material, which led to the formation of aggregates, which is what's described in the Dow declaration, and also with fines.

[00:18:41] Speaker 03:
And when you had that disparate particle size,

[00:18:44] Speaker 03:
You'd get some particles that had too much sodium picosulfate, which is an active ingredient, and some which had too little.

[00:18:50] Speaker 03:
And so the problem, and this is all explained in the Dow Declaration, which is the important part about the Dow Declaration, is it's explaining the improvements in the process in response to an obviousness rejection at the Patent Office.

[00:19:05] Speaker 03:
But I'll get to that in a minute.

[00:19:06] Speaker 03:
So let's go back to the column nine.

[00:19:08] Speaker 03:
The column nine evidence, which is sprayed very evenly,

[00:19:13] Speaker 03:
is not equated at all with how that means substantially evenly surrounding.

[00:19:19] Speaker 03:
And in fact, if you look at the actual language used, it supports Dr. Davies' plain and ordinary meaning, where it says, and this is at line 64, the sodium picosulfate solution may be sprayed very evenly onto the surface of the potassium bicarbonate granules and dried immediately.

[00:19:40] Speaker 03:
That's the whole point of the invention.

[00:19:42] Speaker 03:
You spray it on.

[00:19:44] Speaker 03:
You get an even distribution across the particle bed, and it's dried rapidly so that you don't have this dissolution of the potassium bicarbonate, which leads to the aggregates, which leads to the problem and the disparity in the particle size.

[00:20:01] Speaker 03:
The other part of their construction is their expert took the position that this sprayed very evenly was on a particle by particle basis.

[00:20:11] Speaker 03:
And our expert testified that he couldn't even understand how that could even happen.

[00:20:18] Speaker 03:
Spray coating is a very random process.

[00:20:20] Speaker 03:
Think of it like the lottery machine.

[00:20:24] Speaker 03:
And you've got a top spray coming down, and the spray is going on all of these bouncing little balls.

[00:20:29] Speaker 03:
There's no way that the solution is going to hit every single particle the same way.

[00:20:34] Speaker 03:
And there's no way that you're going to have it substantially evenly surrounding each individual particle.

[00:20:42] Speaker 03:
So let's turn to the two other pieces of evidence that they rely on.

[00:20:48] Speaker 03:
One is this, the images.

[00:20:52] Speaker 03:
Let's talk about the images.

[00:20:53] Speaker 03:
The images were originally in the application and the patent office determined that they lacked clarity and therefore were not of any use and they were removed from the specification.

[00:21:10] Speaker 03:
So they're not part of the specification.

[00:21:12] Speaker 03:
But more importantly, they lack clarity.

[00:21:14] Speaker 03:
But secondly, the point is, the example is not limiting in any way, shape, or form.

[00:21:21] Speaker 03:
It's not like the cases where the court has used examples to be limiting.

[00:21:25] Speaker 03:
For example, the Medicines v. Mylan case, where there was a question of what efficient mixing meant.

[00:21:32] Speaker 03:
And there was no ordinary and customary meaning of what efficient mixing meant.

[00:21:37] Speaker 03:
And the specification was vague.

[00:21:39] Speaker 03:
and gave a laundry list of various mixing techniques.

[00:21:42] Speaker 03:
And so the court looked to two examples, example four, which was inefficient mixing, and example five, which was efficient mixing, to determine what efficient mixing meant.

[00:21:53] Speaker 03:
And they limited the definition of efficient mixing to that particular example.

[00:21:58] Speaker 03:
That's not the situation here.

[00:22:00] Speaker 03:
It's described repeatedly throughout the specification about what the purpose of the invention was,

[00:22:07] Speaker 03:
And the reason was to spray coat so that you could get an even distribution of the sodium picosulfate across the potassium bicarbonate granules.

[00:22:20] Speaker 03:
And therefore, you didn't have the problems in the prior art.

[00:22:22] Speaker 03:
And quite frankly, that's exactly what the Dow Declaration explains.

[00:22:27] Speaker 03:
And it starts in paragraph 7.

[00:22:29] Speaker 03:
He talks about the problems with the prior process, the problems with powdered

[00:22:35] Speaker 03:
dosage forms in general in paragraph 9, and that you had to have equal particle size distributions.

[00:22:43] Speaker 03:
And then he goes on in paragraph 12 to talk about the new process where it's sprayed onto the surfaces of the potassium bicarbonate granules.

[00:22:58] Speaker 03:
And then he said, hence, the premixed granules

[00:23:01] Speaker 03:
were prepared differently, and they contain a core of potassium bicarbonate with an external, again, location, coating of the sodium picosulfate.

[00:23:11] Speaker 03:
So importantly, there's nothing in any of this intrinsic evidence that even gets you close to substantially evenly surrounding.

[00:23:21] Speaker 03:
Surrounding isn't even in the claim language.

[00:23:24] Speaker 03:
I know there's a recent case that came out of this court, Apatales versus Apotex, where

[00:23:30] Speaker 03:
The issue was continuity of an extended release coding.

[00:23:34] Speaker 03:
And in that case, there was the language of surrounding in the claims.

[00:23:38] Speaker 03:
There's none of that language in this case.

[00:23:41] Speaker 03:
And quite frankly, continuity is not even an issue anymore.

[00:23:45] Speaker 03:
Both parties' experts agreed that continuity was not required.

[00:23:49] Speaker 03:
And it all comes down to location.

[00:23:53] Speaker 03:
Where is the sodium picosulfate?

[00:23:56] Speaker 03:
Let's turn to the hard evidence issue.

[00:23:59] Speaker 03:
There was hard evidence.

[00:24:00] Speaker 03:
Dr. Davies did testing of PAR's product.

[00:24:03] Speaker 03:
Dr. Davies came in and testified that all of the images that he saw of the particles from PAR's process had the sodium picosulfate on the outer surface, namely an external coating of the sodium picosulfate on the potassium bicarbonate granules.

[00:24:20] Speaker 03:
He testified he never saw any particles where there was potassium bicarbonate

[00:24:28] Speaker 03:
I mean, excuse me, sodium picosulfate in the core.

[00:24:32] Speaker 03:
That's important.

[00:24:33] Speaker 03:
Also, Dr. Johnson relied upon Dr. Davey's testing as confirming that because that he saw no agglomerates, which is what you would get in a wet granulation process, it confirmed his opinion that the process was spray coating.

[00:24:50] Speaker 03:
Let's talk about Dr. Johnson.

[00:24:51] Speaker 03:
Dr. Johnson has 20 years of experience with spraying processes.

[00:24:58] Speaker 03:
experience both with wet granulation and spray coating.

[00:25:02] Speaker 03:
That's testimony that's in the record.

[00:25:04] Speaker 03:
That's testimony that the district court heard.

[00:25:07] Speaker 03:
He did a detailed analysis of PAR's process.

[00:25:11] Speaker 03:
He looked at the executed batch records, which we, let's not muddy the water here.

[00:25:19] Speaker 03:
We all agree the ANDA is the best evidence of what the product is, the likely product that is going to be sold.

[00:25:24] Speaker 03:
But let's take a look at what those cases are saying.

[00:25:27] Speaker 03:
They're not saying it's the label that you put on it in the discussion of your ANDA of what it is.

[00:25:37] Speaker 03:
It's the specifications.

[00:25:38] Speaker 02:
Can I ask a question about those cases before you go on?

[00:25:40] Speaker 02:
Sure.

[00:25:41] Speaker 02:
In those cases, are those situations where the ANDA, the party that drafted the ANDA, was trying to take a different tact than how the ANDA labeled the product?

[00:25:56] Speaker 02:
Or is that true?

[00:25:57] Speaker 03:
No, I don't think so.

[00:25:59] Speaker 03:
I can talk specifically about buyer via loan because I was involved in that case.

[00:26:04] Speaker 03:
In that case, they came in and they had a specification for a specific surface area of the active ingredient.

[00:26:11] Speaker 03:
And the original specification would lead to infringement.

[00:26:16] Speaker 03:
During the course of discovery, they changed the specification, altered it such that they could never infringe on the patent.

[00:26:23] Speaker 03:
And the court found that they were legally obligated to follow that specification.

[00:26:28] Speaker 03:
And therefore, they could not.

[00:26:30] Speaker 03:
The product they were likely to sell could not in French.

[00:26:34] Speaker 03:
But the important point is it's the specifications that govern.

[00:26:39] Speaker 03:
Dr. Johnson looked in detail at the executed batch records.

[00:26:45] Speaker 03:
He went by process parameter by process parameter.

[00:26:49] Speaker 03:
He evaluated them.

[00:26:50] Speaker 03:
He looked at each of them individually, and then in the totality, he said, looking at this process as a whole, based on all these process parameters, in my mind, there's no question it's break coding.

[00:27:05] Speaker 03:
He was cross-examined on it.

[00:27:07] Speaker 03:
He was cross-examined about his relative terms, obviously

[00:27:12] Speaker 03:
That did not affect the judge's determination and his credibility.

[00:27:16] Speaker 03:
It was a credibility determination.

[00:27:18] Speaker 03:
He heard both experts testify, and he found Dr. Johnson to be more credible than Dr. Oxford.

[00:27:24] Speaker 04:
Could you address the O2 micro argument?

[00:27:27] Speaker 03:
Sure.

[00:27:28] Speaker 03:
First off, this was a bench trial, so I'm not so sure O2 micro even applies.

[00:27:35] Speaker 03:
But what I would say is Judge Andrews actually determined claim scope

[00:27:42] Speaker 03:
at the markman.

[00:27:43] Speaker 03:
What he did was he considered all of the intrinsic evidence that was cited by par, and he found it to not be limiting.

[00:27:51] Speaker 03:
And therefore, he gave the term coded encoding, the only terms that were at issue at that point, their plain and ordinary meaning as Phillips instructs.

[00:28:01] Speaker 04:
Would you consider an order in limiting with respect to its construction?

[00:28:06] Speaker 04:
Excuse me?

[00:28:06] Speaker 04:
An order in limiting?

[00:28:08] Speaker 04:
Was there emotional?

[00:28:08] Speaker 03:
There was.

[00:28:09] Speaker 03:
There was.

[00:28:09] Speaker 03:
And I can explain that.

[00:28:10] Speaker 03:
So what happened was, so we went through claim construction, came up.

[00:28:16] Speaker 03:
PAR had two constructions at the time.

[00:28:19] Speaker 03:
One was a shell that surrounds a core.

[00:28:21] Speaker 03:
And then there was a discussion of covering layer.

[00:28:23] Speaker 03:
The court basically came out and said, I'm going to give it its plain and ordinary meaning.

[00:28:27] Speaker 03:
I find the intrinsic evidence, the very intrinsic evidence that they continued to rely upon at trial to not be limiting.

[00:28:34] Speaker 03:
We went through expert discovery, and their expert came up with a new construction.

[00:28:39] Speaker 03:
There were all these ever-changing constructions.

[00:28:41] Speaker 03:
Then it became substantially evenly surrounding, was the limitation that they put forward both for coding and coding and for this new term layer that they decided needed to be construed after the markman.

[00:28:52] Speaker 03:
But the key was they had this substantially evenly surrounding language, which to this day, their expert

[00:29:00] Speaker 03:
testified at trial that he didn't even know how you would determine what technical test you would make to determine whether it was substantially evenly surrounded.

[00:29:11] Speaker 03:
He basically said, I can tell you that it's not, but I can't tell you what it is.

[00:29:18] Speaker 03:
I don't know how to tell you it is, substantially evenly surrounding.

[00:29:21] Speaker 03:
So that construction provides no clarity, as the judge would say.

[00:29:29] Speaker 03:
So then we got to try, there was a motion in Lemony to answer your honor's question.

[00:29:35] Speaker 03:
So what happened was we said, they're still trying to do claim construction throughout expert discovery, so we filed a motion in Lemony.

[00:29:43] Speaker 03:
Now, importantly, the judge denied the motion in Lemony, but in doing so, he said, I'm not going to allow you to introduce the intrinsic evidence that I've already determined is not limiting for claim construction purposes.

[00:29:55] Speaker 03:
I allow you to introduce it for other purposes,

[00:29:59] Speaker 03:
And on an objection by objection basis, I'll determine whether that's claim construction or whether that's used for some other purpose.

[00:30:10] Speaker 03:
We went through trial, and we continued to object it and did as the judge instructed.

[00:30:17] Speaker 03:
And in his opinion, he came down and agreed with us that Dr. Augsburger was still trying to do a claim construction.

[00:30:23] Speaker 03:
So I understand that my time is out.

[00:30:25] Speaker 03:
Are there any further questions?

[00:30:29] Speaker 03:
Thank you.

[00:30:29] Speaker 03:
Thank you very much.

[00:30:37] Speaker 01:
Thank you.

[00:30:38] Speaker 01:
Just a couple of issues to clarify.

[00:30:40] Speaker 01:
First, they neglected to tell you that the first time they gave a construction ever on the meaning of the terms was after Markman.

[00:30:50] Speaker 01:
So the only time that we could have addressed that construction was at trial, yet the district court denied us

[00:30:58] Speaker 01:
the very evidence necessary to rebut their first time presented construction.

[00:31:04] Speaker 01:
Regarding the bulk material issue, the claim should not be limited to the bulk material.

[00:31:11] Speaker 01:
The claims are very clear.

[00:31:13] Speaker 01:
A layer, singular, on A core, singular.

[00:31:17] Speaker 01:
There's nothing about bulk material.

[00:31:20] Speaker 01:
The citations that they give are vague to the specification, and they don't trump

[00:31:27] Speaker 01:
the very clear intrinsic evidence that shows that the exact invention that the inventor invented is what he wanted to limit the claims to.

[00:31:40] Speaker 01:
And I see my time's up.

[00:31:42] Speaker 01:
If there are any questions?

[00:31:43] Speaker 01:
He can conclude.

[00:31:44] Speaker 01:
Thank you.

[00:31:46] Speaker 01:
Regarding the Dr. Davies, yes, Dr. Davies testified that the five dots were a layer.

[00:31:54] Speaker 01:
What we're saying is, under the correct claim construction, that cannot be a layer.

[00:31:58] Speaker 01:
Thank you very much, Your Honor.

[00:32:00] Speaker 04:
OK, thank you.

[00:32:00] Speaker 04:
That's arguments for the day.

[00:32:02] Speaker 04:
This court will now take these under advisement.