[00:00:04] Speaker 02:
Mr. Missouri saying it right May it please the court I represent Sigma farm and given the short time I

[00:00:17] Speaker 02:
I will focus my comments on the 945 patent issues and submit the 208 patent issues on the brief unless the court has any specific questions, of course.

[00:00:27] Speaker 02:
With respect to the 945 patent for Sigma Pharm, this case presents the simple question of what is a particle?

[00:00:39] Speaker 02:
A particle is an individual discrete portion of something.

[00:00:43] Speaker 02:
And contrary to what the district court found

[00:00:47] Speaker 02:
A crystal embedded in a particle is not itself an individual particle.

[00:00:53] Speaker 02:
At best, that is what the evidence in this case showed.

[00:00:57] Speaker 02:
That within some mixture of PVP and a pixaban, there are some crystals of a pixaban that are a few nanometers in dimension.

[00:01:09] Speaker 06:
So your argument boils down to, as I see it, is that because the product contains

[00:01:17] Speaker 06:
epixaban as well as other excipients it therefore can't in French?

[00:01:23] Speaker 02:
Well, no, I'm saying the particles in our product are composed of PVP, epixaban, and some of that epixaban is actually crystalline and amorphous.

[00:01:34] Speaker 02:
And so the point that we're making is that the evidence is undisputed that the particles in our product are composed of a mixture of crystalline and amorphous, epixaban and PVP,

[00:01:46] Speaker 02:
And their expert admitted that particles with that composition are not crystalline or pixaban particles.

[00:01:54] Speaker 06:
Well, I read that expert testimony, and I don't really think that's what the expert said.

[00:02:00] Speaker 06:
I mean, he didn't say that they're no longer crystalline.

[00:02:04] Speaker 02:
No, he said that a particle that is composed of pixaban and other stuff

[00:02:14] Speaker 02:
would not be a crystalline, a pixaban particle, because there would be other stuff in the particle.

[00:02:20] Speaker 02:
And so our view is that the idea that you can count the crystals that are embedded in a PVP, a pixaban particle, as being themselves individual particles is contrary to the plain language, the plain and ordinary meaning of the word particle.

[00:02:36] Speaker 02:
It's the plain language itself, the written description, the file history, and this court's precedence.

[00:02:42] Speaker 02:
This finding is a clear error of fact and law.

[00:02:46] Speaker 06:
What do we do about the fact that the district court completely disagreed with your interpretation of that expert testimony, which I think I do too, having read it?

[00:02:55] Speaker 06:
That is a factual and credibility determination.

[00:02:58] Speaker 06:
How do we get around that?

[00:03:00] Speaker 02:
Well, I don't think that what a particle is, for purposes of this case, is a legal question about what the claim term means.

[00:03:07] Speaker 02:
What is the plain and ordinary meaning of the word particle?

[00:03:09] Speaker 02:
in the context of this patent.

[00:03:13] Speaker 02:
So a crystal within a particle itself is not a particle.

[00:03:16] Speaker 02:
It's like saying that a slab of granite contains a statue before the sculptor sculpts it from the slab.

[00:03:27] Speaker 02:
And if you look at the claim language, saying that all crystals are particles renders the term particle superfluous.

[00:03:36] Speaker 02:
The patent did not claim a pixavan crystals

[00:03:39] Speaker 02:
with a D90 of 89 microns, it claimed crystalline epixaban particles with the claimed particle size.

[00:03:49] Speaker 02:
Now, the written description is also consistent.

[00:03:52] Speaker 02:
It says at column three, line 20, that particles refers to individual drug substance particles, whether the particles exist singly or are agglomerated.

[00:04:04] Speaker 02:
Now, a crystal in a particle is not an agglomerate of the crystal

[00:04:09] Speaker 02:
and the PVP.

[00:04:11] Speaker 02:
It makes absolutely no sense.

[00:04:14] Speaker 02:
And this argument is also consistent with the file history.

[00:04:18] Speaker 02:
We talk about Naus, the Naus case.

[00:04:20] Speaker 02:
Naus was a solid amorphous dispersion composed of a pixaban.

[00:04:23] Speaker 05:
You want to save any of your rebuttal time, counsel?

[00:04:25] Speaker 05:
You're now into your rebuttal time.

[00:04:28] Speaker 02:
Unless the court has any questions, I will reserve my ranger's time for rebuttal.

[00:04:32] Speaker 02:
Very good.

[00:04:56] Speaker 01:
Thank you, Your Honor.

[00:04:59] Speaker 01:
May it please the Court.

[00:05:02] Speaker 01:
Ms.

[00:05:02] Speaker 01:
Gurlan and I are here on behalf of the appellants Sunshine Lake and HEC Farm.

[00:05:11] Speaker 01:
And because of the constraints on time, I only want to address a few salient points, and primarily with respect to the claim construction issue.

[00:05:20] Speaker 01:
It is our position that Judge Stark, in his decision, in his claim construction decision, was wrong as a matter of law with respect to his interpretation.

[00:05:32] Speaker 01:
That interpretation was plain for the phrase, crystal in the pixaban particles having a D90 equal to arresting.

[00:05:42] Speaker 06:
Because I know you have very little time.

[00:05:43] Speaker 06:
Let me just move this forward.

[00:05:44] Speaker 06:
So you are assuming that the claims must cover a form of measurement, right?

[00:05:51] Speaker 01:
measurement or calculation.

[00:05:54] Speaker 01:
That's what the demand is.

[00:05:56] Speaker 06:
Okay, so anytime a claim has any kind of range that it necessarily subsumes the method for measuring that range.

[00:06:06] Speaker 01:
Well, and I agree contrary to what Judge Stark said, we do not believe that the

[00:06:16] Speaker 01:
with respect to claim construction.

[00:06:19] Speaker 01:
What our position is with respect to claim construction... Wait, I thought you just told me it was.

[00:06:24] Speaker 01:
No, I did not, Your Honor.

[00:06:26] Speaker 01:
Let me correct myself if that's the impression you gave.

[00:06:29] Speaker 01:
The claim construction here and the issue of laser light scattering was not what the appellants were arguing.

[00:06:38] Speaker 01:
What we were arguing is that

[00:06:40] Speaker 01:
the claim crystalline epixaban particles meant bulk API crystalline epixaban pre-formulated and not formulated epixaban.

[00:06:56] Speaker 01:
And we based that argument on what was set forth in the prosecution history.

[00:07:02] Speaker 01:
And that is to get the claims allowed, okay, the patent examiner

[00:07:09] Speaker 01:
in the interview summary, put it best by saying, and that's at appendix 251-8.

[00:07:15] Speaker 06:
I really confused her, because your whole bulk argument depends on there being a required form of measurement, right?

[00:07:25] Speaker 01:
Not by the claim.

[00:07:26] Speaker 01:
No, Your Honor, it doesn't.

[00:07:28] Speaker 01:
That's not what we're saying.

[00:07:30] Speaker 01:
We're saying that, yes, you have to measure the bulk.

[00:07:34] Speaker 01:
The bulk has to have a d90 of less than or equal to 89.

[00:07:41] Speaker 01:
But it's the bulk that's being measured, not the formulated epixaban.

[00:07:46] Speaker 01:
And that's what's very important.

[00:07:48] Speaker 01:
To obtain this patent, the patent, the applicants had to argue

[00:07:57] Speaker 01:
figures three and four in the patent.

[00:08:00] Speaker 01:
And what do figures three and four show?

[00:08:02] Speaker 01:
They show the relationship between a tablet with a specific pre-measured bulk of pixaban as compared to the dissolution characteristics.

[00:08:15] Speaker 01:
And the examiner recognized that and found that to be the criticality, the unexpected result.

[00:08:22] Speaker 01:
Therefore, the scope of the claim

[00:08:26] Speaker 01:
that we're arguing here requires that the crystalline and pixel band particles be pre-formulated having that specific measurement requirement set forth in a claim.

[00:08:41] Speaker 06:
You seem to be confusing premises with conclusions.

[00:08:46] Speaker 06:
I mean, your premise, which I still think is the wrong one, is that the measurement is a limitation.

[00:08:53] Speaker 06:
The patent use then say only discloses one method of measurement and so therefore it has to be measuring the bulk, right?

[00:09:04] Speaker 06:
By the method it discloses in the specification, yes.

[00:09:09] Speaker 06:
But getting to the bulk is the conclusion.

[00:09:11] Speaker 06:
You have to start with the premise, right?

[00:09:14] Speaker 06:
If you don't have a premise of requiring a particular methodology for testing, then you never get to the bulk conclusion, right?

[00:09:23] Speaker 01:
But there was well-known methods and methodology for testing bulk crystalline forms at that time.

[00:09:31] Speaker 01:
In the patent, the patentee disclosed, I think, seven times laser light scattering.

[00:09:37] Speaker 01:
In fact, in discussing the examples in the patent.

[00:09:42] Speaker 06:
Right, so you're saying the only method of measurement that can be covered is the laser light scattering.

[00:09:48] Speaker 01:
No, I'm saying any measurement that can be made

[00:09:53] Speaker 01:
to determine D90 being less than or equal to 89 of a pre-formulated crystalline material.

[00:10:03] Speaker 01:
That's what I'm saying, Your Honor.

[00:10:04] Speaker 06:
So you're saying that the district court's conclusion that measurement is not part of the claim is clearly erroneous.

[00:10:14] Speaker 06:
Or before actually because it's part of the claim construction.

[00:10:17] Speaker 01:
It would be wrong as a matter of law correct Your honor that that's what we're arguing.

[00:10:21] Speaker 01:
That is correct.

[00:10:23] Speaker 05:
So I'm like judge I don't see anything in the D90 claim term that limits it to pre formulated particle sizes and

[00:10:33] Speaker 05:
So I'm confused.

[00:10:35] Speaker 05:
I thought I understood your brief and the Unicam brief, and I know you don't represent them, and I'll hear from them in a minute, as both suggesting that the only disclosure was laser light scattering, and that can only be performed on both a fixed band, and that that's why we know that the D90 term has to be limited to a pre-formulated particle size.

[00:10:57] Speaker 05:
That's what I thought.

[00:10:59] Speaker 01:
That is our argument, Your Honor.

[00:11:00] Speaker 01:
Yes.

[00:11:03] Speaker 05:
All right.

[00:11:05] Speaker 05:
Sit down.

[00:11:06] Speaker 05:
Let's hear from the last person then.

[00:11:12] Speaker 05:
I don't, I'm sorry, I don't know how to say your last name.

[00:11:14] Speaker 05:
Is it Pajic?

[00:11:16] Speaker 05:
Pajic?

[00:11:17] Speaker 05:
Okay, please, Mr. Pajic, come forward.

[00:11:45] Speaker 05:
I'm assuming you're just going to pick right up where he left off because you all have basically the same argument, which I understand to be the reason the D-90 claim term should be limited to pre-formulated particles is because the method of measure throughout is laser light scattering.

[00:12:02] Speaker 05:
and that's only possible in bulk epixaban.

[00:12:04] Speaker 05:
So even though the claim itself may not have anything in the D90 limitation that suggests it's limited to bulk epixaban, you think it nonetheless is for that reason.

[00:12:13] Speaker 05:
Am I understanding your argument?

[00:12:15] Speaker 00:
Yes, Your Honor, but it's slightly different.

[00:12:19] Speaker 00:
We don't require laser light scattering to be part of the claim.

[00:12:24] Speaker 00:
It's the D90 that requires it to be the bulk of Pixaban because one skilled in the art would not know how to measure the D90 of any tableted API.

[00:12:35] Speaker 00:
The record is very clear at trial that no expert, no POSA, much less an expert at trial, has ever determined the D90 of a tableted API.

[00:12:47] Speaker 00:
And in fact, at the time the patents, the 945 patent was filed, as well as today, the industry standard was the fact, was to measure bulk APIs and then manufacture the tablets.

[00:13:02] Speaker 00:
That's exactly what the inventors did in this case.

[00:13:05] Speaker 06:
So you want us to rely on Dr. Ghent's testing?

[00:13:09] Speaker 06:
Pardon me, Your Honor.

[00:13:09] Speaker 06:
You want us to rely on Dr. Ghent's testing?

[00:13:11] Speaker 00:
I rely on Dr. Ghent and Dr. Meyerson.

[00:13:14] Speaker 06:
But what do we do with the fact that the district court said he didn't find Dr. Ghent's testing to be reliable?

[00:13:24] Speaker 06:
Because it started with the beginning packs of band material and not with what ended up in the final product.

[00:13:34] Speaker 06:
We specifically found that that was not credible or reliable methodology.

[00:13:41] Speaker 00:
Correct.

[00:13:41] Speaker 00:
But I'm also relying on Dr. Meyerson's appellees expert, who also conceded that no HOSA had ever determined the D9B of a tableted API.

[00:13:54] Speaker 00:
So I'm not relying solely on the doctor.

[00:13:56] Speaker 06:
Well, what about the fact that the court relied on Dr. Atwood's testimony?

[00:14:01] Speaker 00:
I'm sorry, Your Honor.

[00:14:03] Speaker 06:
The court relied on Dr. Atwood's testimony, did it not?

[00:14:06] Speaker 00:
To find that you could determine the D90 of a tableted?

[00:14:10] Speaker 06:
That you have to determine it based on the end product.

[00:14:15] Speaker 00:
On the same process?

[00:14:16] Speaker 00:
On the end product.

[00:14:18] Speaker 00:
No, the claim itself says, and what the court found enabled here, was its tablets made from a PIXBAN having a specified known D90.

[00:14:29] Speaker 00:
That is what all the unexpected results are based upon in figures three and four in the prosecution history.

[00:14:35] Speaker 00:
There is no disclosure whatsoever in the 495 patent of how to determine the D90 in the finished tablet.

[00:14:44] Speaker 00:
And again, the evidence showed that no one has ever done so.

[00:14:47] Speaker 00:
The industry standard, like what the inventors did here, was simply to make tablets with a pre-known and predetermined D90.

[00:14:58] Speaker 00:
That's what the inventors did.

[00:14:59] Speaker 00:
That's what the industry standard was.

[00:15:01] Speaker 00:
And that's what a post of reading the specification would understand.

[00:15:05] Speaker 00:
Because there's simply no disclosure of how to measure the D90 of anything in the tablet.

[00:15:10] Speaker 06:
So this boils down to you disagreeing with Dr. Atwood's methodology for saying that the end tablet had to have certain levels, right?

[00:15:25] Speaker 00:
I don't disagree with Dr. Atwood.

[00:15:27] Speaker 00:
I'm just saying the claims cannot cover that because no one would know how to measure it.

[00:15:32] Speaker 06:
But he said that your manufacturing process would necessarily result in you having that amount, right?

[00:15:44] Speaker 00:
Oh, now I understand.

[00:15:46] Speaker 00:
I'm sorry.

[00:15:46] Speaker 00:
You're asking more along the questions of how to prove infringement.

[00:15:50] Speaker 00:
That's not what I'm talking here.

[00:15:51] Speaker 06:
Right, but he said there was a way to do this analysis and know exactly what the measurement would be, right?

[00:15:59] Speaker 00:
I do not believe that's the case.

[00:16:00] Speaker 00:
In fact, I posed him, and he said there was no way to understand that and to measure the D90 in the tablet.

[00:16:13] Speaker 00:
I don't, there's no place in the record that shows any POSA, much less an expert, that actually determined...

[00:16:20] Speaker 06:
Clearly, he didn't do the physical testing, but the district court credited his circumstantial evidence with respect to what your manufacturing process would necessarily result in, correct?

[00:16:35] Speaker 00:
Again, I'm not talking about the unicam manufacturing process, Your Honor.

[00:16:39] Speaker 00:
I'm talking about the disclosure and the patent and what is described as the invention.

[00:16:45] Speaker 00:
What is enabled is the invention.

[00:16:47] Speaker 00:
And that is a tablet made with a Pixaban having a known B90.

[00:16:53] Speaker 00:
If you look at figures three and four, almost out of my time.

[00:16:56] Speaker 00:
Could I finish?

[00:16:58] Speaker 00:
Yes.

[00:16:58] Speaker 00:
And so figures three and four, all the unexpected results, all talk about tablets made from a Pixaban having a certain D90.

[00:17:07] Speaker 00:
There's no place in the patent that mentions or talks about determining the D90 in a finished tablet.

[00:17:13] Speaker 00:
And there's no prior art that shows that it's ever been done.

[00:17:16] Speaker 05:
You're talking about measuring.

[00:17:18] Speaker 05:
But aren't there, unless I'm mistaken and I'm looking at the appendix, for example, at page 23, A23,

[00:17:27] Speaker 05:
Aren't there processes of formulation that produce crystals that necessarily limit their size so that if that process was used, we would know that it complies with the D90?

[00:17:39] Speaker 05:
I mean, I guess I understood the district court to find kind of exactly like Judge O'Malley was explaining that there are formulation processes that absolutely result in products that would infringe this claim and be known to infringe this claim because they limit the size the crystal can be.

[00:17:55] Speaker 05:
Is that not a correct understanding?

[00:17:57] Speaker 00:
But it's always, you have to start.

[00:17:59] Speaker 00:
In fact, the court's finding of enablement relies solely upon a tablet that's made with balkapixaban having a D90 of less than or equal to 89 microns.

[00:18:12] Speaker 00:
There's nothing in the record, any place, that if you start with an API having a larger D90 than 89 microns, like unichems, that it would ever infringe.

[00:18:25] Speaker 00:
The only thing that is described and the only invention that is enabled is one, is a tablet made from a Pixaban having a specified D90.

[00:18:37] Speaker 05:
Okay, Mr. Pecek, thank you very much.

[00:18:40] Speaker 05:
Let's hear from Mr. Lee.

[00:18:55] Speaker 04:
Give them just a second to get situated.

[00:19:09] Speaker 03:
May I proceed, Your Honor?

[00:19:10] Speaker 04:
Yes, please proceed.

[00:19:11] Speaker 03:
May I please record?

[00:19:13] Speaker 03:
My name is Bill Lee, and together with my partner, Andrew Danforth, I represent the appellees, Bristol, Myers, Quibb, and Pfizer.

[00:19:19] Speaker 03:
I'm not going to address the 208 patent today, since none of the appellants have addressed the 208 patent.

[00:19:25] Speaker 03:
And as I heard the argument, there were only two issues that were discussed with the court, and I'll address those, too.

[00:19:31] Speaker 03:
And let me begin with Sigma Pharm's argument about crystalline and pixaban particles.

[00:19:37] Speaker 03:
And to set the record straight,

[00:19:40] Speaker 03:
There was no request that this term be construed below.

[00:19:44] Speaker 03:
There was never a request to Chief Judge Stark that there be a claim construction of the term.

[00:19:49] Speaker 03:
There was never a suggestion that it had anything other than a claim in ordinary meaning.

[00:19:53] Speaker 03:
And that's what Judge Stark applied and then found as a matter of fact that chrysaline pickspan particles existed in the accused products.

[00:20:04] Speaker 03:
That was based on the testimony of Dr. Atwood, Dr. Munson,

[00:20:09] Speaker 03:
two different types of testing, all of which showed the existence of crystalline and pixel band particles.

[00:20:17] Speaker 03:
Now, the argument today waxed between sort of a claim construction and sort of challenging the factual findings.

[00:20:25] Speaker 03:
The factual findings are very specific, very detailed, based upon the experts and based upon

[00:20:32] Speaker 03:
the court's assessment of those experts.

[00:20:36] Speaker 03:
To the extent this is a claim construction argument offered to the court, it is too late, but it also doesn't make any sense to go to the composite discussion that Judge Romali had with the appellants

[00:20:49] Speaker 03:
We're not claiming that composite particles demonstrate infringement.

[00:20:54] Speaker 03:
In fact, what we contend is that Dr. Edwin and Dr. Munson's testing, the XRPD and SSNMR testing, showed the existence of crystalline epicspan particles, and that's what they said.

[00:21:07] Speaker 03:
The testimony that was cited to Your Honor was

[00:21:10] Speaker 03:
doctor at would be being given a Hypothetical about a composite particle and his saying well that I would accept what you say That wouldn't be the particle, but then if you read on immediately says, but if you look at the chrysalin the pix band particle That's what I found the only other two points made to you on this were one about now and The chronology here is very important There were original claims that did not have the dissolution rate limitation

[00:21:40] Speaker 03:
They were rejected over NAUSE.

[00:21:43] Speaker 03:
There was an amendment to add the dissolution rate limitation, which was core to the invention.

[00:21:49] Speaker 03:
Then the examiner allowed it, not because NAUSE had amorphous PIXPAN, not because it had some mixture of amorphous PIXPAN and crystalline PIXPAN, but because NAUSE was a controlled release formulation, and this was an immediate release formulation.

[00:22:05] Speaker 03:
And the examiner so said.

[00:22:07] Speaker 06:
So let me turn you to something else.

[00:22:10] Speaker 06:
laser light testing.

[00:22:14] Speaker 03:
Yes, Your Honor.

[00:22:14] Speaker 06:
You admit it can only be done on bulk, right?

[00:22:17] Speaker 03:
The laser light testing can only be done on bulk.

[00:22:19] Speaker 03:
And actually, Your Honor, the contention to Chief Judd Stark was the claims actually require laser light testing on bulk.

[00:22:28] Speaker 06:
But you agree that the only thing disclosed in the written description in terms of discussing testing is laser light testing.

[00:22:37] Speaker 03:
That is the method that was used as a historical matter of fact to make the claim invention.

[00:22:42] Speaker 06:
OK, so why isn't that meaningful?

[00:22:44] Speaker 03:
Your Honor, it's two reasons.

[00:22:47] Speaker 03:
One is we have to look at the claims.

[00:22:49] Speaker 03:
And the claims refer, and if I take you to the specific claim language, the claims themselves refer to a solid pharmaceutical composition.

[00:22:57] Speaker 03:
They're talking about the D-90.

[00:22:59] Speaker 03:
And incidentally,

[00:23:00] Speaker 03:
The D-90 is not something that you have to measure.

[00:23:03] Speaker 03:
It's a threshold that you have to stay below.

[00:23:06] Speaker 03:
It's not something that you have to identify specifically.

[00:23:10] Speaker 03:
So the claims themselves talk about a solid pharmaceutical composition.

[00:23:14] Speaker 03:
They're not talking about the bulk.

[00:23:16] Speaker 03:
And the D-90 threshold that's described in the claims is in that solid pharmaceutical composition.

[00:23:23] Speaker 03:
If there are any doubt about that, if I took the court to column 5, line 18 to 21,

[00:23:30] Speaker 03:
of the specification.

[00:23:32] Speaker 03:
It's at A262.

[00:23:39] Speaker 03:
This is the place where they explain the particle size.

[00:23:48] Speaker 03:
And what the court will see is it is saying what is consistent with the claims, which is it's particle size at the site of dissolution.

[00:23:57] Speaker 03:
That's not the bulk of pixaban.

[00:23:59] Speaker 03:
That's the formulated pixaban that is administered to a patient.

[00:24:04] Speaker 03:
And in fact, it says produce primary particles at the site of dissolution.

[00:24:10] Speaker 03:
So the claim term, Your Honor, to answer your question is talking about the pharmaceutical composition

[00:24:17] Speaker 03:
that D90 and the particles that are being referred to are described as at the point of dissolution.

[00:24:24] Speaker 03:
To be sure, the laser light scattering is identified as a method used to measure bulk of pix band.

[00:24:31] Speaker 03:
The specification is describing as a historical matter of fact that bulk of pix band can be formulated

[00:24:39] Speaker 05:
measured and then dry-grain related so that the... sorry to interrupt but do I understand it right that the district court judge held that this D-90 measure of 89 or less less than 89 something like that could be performed or could be is it can it be on either pre-formulated or post-formulated meaning it could be

[00:25:01] Speaker 05:
They're going to infringe if they've got 89 or less when it's in bulk, and they're also going to infringe when they've got 89 or less when it's in the formulated.

[00:25:10] Speaker 05:
Is that right?

[00:25:11] Speaker 03:
Your Honor, no.

[00:25:12] Speaker 03:
The second half is exactly correct.

[00:25:15] Speaker 03:
If the D90 for the formulated epixaban, the pharmaceutical composition, is below the threshold, you infringe.

[00:25:24] Speaker 03:
But it's not in bulk.

[00:25:26] Speaker 03:
On the bulk, there would be a second part to the district court's analysis, which is if the D-90 is measured in bulk, then you have to use a process that will ensure that the D-90 is not going to change and get bigger during the course of the process.

[00:25:44] Speaker 05:
And he found it's a matter of- That helps because if I view this claim the way that you were explaining earlier,

[00:25:50] Speaker 05:
which is it's applying to the solid pharmaceutical composition, i.e.

[00:25:54] Speaker 05:
the thing that the patient is going to be given for the most part, the end product, then you're right.

[00:25:59] Speaker 05:
If this claim covered measuring D90 in bulk, and then if a process was used where it would push it larger, that would cause me a concern for claim construction infringement analysis, all of that.

[00:26:12] Speaker 03:
And your honor would be correct.

[00:26:13] Speaker 03:
And what the district court said are two things that are related.

[00:26:17] Speaker 03:
One is that

[00:26:18] Speaker 03:
in the specification.

[00:26:20] Speaker 03:
The process that's identified is a process that measured it in bulk but then used a dry granulation process that would not increase the size and therefore you would have the required D90.

[00:26:33] Speaker 03:
The district also said that there were other methods that you could use to measure the particle size in the final tablets.

[00:26:42] Speaker 03:
I want to clarify one thing.

[00:26:43] Speaker 05:
There are other methods you can use to measure the particle size in the final tablets or are there

[00:26:48] Speaker 05:
Yeah, okay, explain that to me.

[00:26:51] Speaker 03:
This is a very fine point that I wanted to make about the argument that you just heard.

[00:26:56] Speaker 03:
There's the argument that no one has measured that D90 in the tablet.

[00:27:02] Speaker 03:
We don't disagree with that.

[00:27:04] Speaker 03:
there were methods specifically identified by the district court that were known to one of organized scale that would have allowed you to measure the particle size if you wanted to do that.

[00:27:13] Speaker 05:
Like electron microscopy?

[00:27:16] Speaker 03:
Yes.

[00:27:16] Speaker 03:
And he identified like six different methods.

[00:27:18] Speaker 03:
Okay.

[00:27:19] Speaker 03:
And once you have those measurements, you can determine the D90.

[00:27:23] Speaker 03:
The D90 is just a threshold that you need to stay before and you want the distribution to be below that.

[00:27:29] Speaker 03:
And what's happened here is

[00:27:31] Speaker 03:
the appellants have tried, in order to overturn the district court's judgment, they have tried to take that requirement and make it a requirement of measuring an absolute amount in bulk, which doesn't make sense if you read the claim or the specification.

[00:27:50] Speaker 03:
And ultimately, it's inconsistent with what the invention was.

[00:27:54] Speaker 03:
The invention here was a dissolution rate limitation that improved bioavailability that allowed

[00:28:02] Speaker 03:
allowed there to be better bioavailability to... So it's just staying below a threshold.

[00:28:10] Speaker 03:
It's staying below a threshold.

[00:28:12] Speaker 03:
And the last thing I'll say on this point is this.

[00:28:15] Speaker 03:
If you look at Sunshine Lake's reply brief, the argument that was made below was you have to use laser light scattering on bulk.

[00:28:25] Speaker 03:
The district court rejected that at Markman and said, no, there's no specific requirement of the manner in which you measure, which is correct.

[00:28:34] Speaker 03:
At trial, as Kiergermelli pointed out, Dr. Gank testified and testified that there was no infringement.

[00:28:40] Speaker 03:
But he said he got to that conclusion by rejecting the district court's claim construction and continuing to apply the one that he had offered before that required laser light scattering.

[00:28:51] Speaker 03:
So the fact that district court didn't find him credible is

[00:28:55] Speaker 03:
Not surprising.

[00:28:57] Speaker 03:
In the reply between three and four, the target has moved again.

[00:29:01] Speaker 03:
And now the target is, it doesn't have to be laser light scattering.

[00:29:04] Speaker 03:
It just has to be in bulk.

[00:29:06] Speaker 03:
That has the same problems.

[00:29:08] Speaker 03:
And it's not in the claims.

[00:29:09] Speaker 03:
It's not consistent with the claims.

[00:29:11] Speaker 03:
And it doesn't save them from infringement.

[00:29:14] Speaker 06:
What do you do with Unicom's product by process argument?

[00:29:18] Speaker 03:
It's not a product by process claim, Your Honor.

[00:29:23] Speaker 03:
There are limited circumstances when you can incorporate a process into a claim.

[00:29:27] Speaker 03:
If you had a traditional product by process claim written as such, which this one is not, you might.

[00:29:33] Speaker 03:
If there was a specific lexicography, you might.

[00:29:36] Speaker 03:
If there was specific prior art that you distinguished, which is why I just asked, you might.

[00:29:42] Speaker 03:
None of those apply here.

[00:29:43] Speaker 03:
And the general proposition that for this type of claim you don't read into process should apply.

[00:29:50] Speaker 03:
Unless there are further questions, I will cede my remaining time.

[00:29:54] Speaker 05:
Thank you, Mr. Lee.

[00:29:59] Speaker 05:
Mr. Mazurk, you have some rebuttal time?

[00:30:06] Speaker 02:
Your Honor, I'd like to focus on a couple things that Council said during his presentation.

[00:30:14] Speaker 02:
He said that Dr. Munson and Dr. Atwood did some tests, NMR and XRP tests, to determine that there were crystals.

[00:30:22] Speaker 02:
And he said that they found crystalline particles.

[00:30:24] Speaker 02:
No, their testing was not to determine or find crystalline particles.

[00:30:29] Speaker 02:
It was to find crystals.

[00:30:32] Speaker 02:
And you can't have this slight of hand.

[00:30:33] Speaker 02:
And that makes our point that there's two terms in the claim, crystalline and crystalline particles.

[00:30:41] Speaker 02:
make the particle word superfluous.

[00:30:45] Speaker 02:
And that's where you have to take a look at now.

[00:30:46] Speaker 05:
But this sounds like a claim construction argument you didn't make.

[00:30:48] Speaker 02:
No, actually, I would say the other problem is he made a claim construction argument that he didn't make.

[00:30:54] Speaker 02:
We argue for plain and ordinary meaning of what a particle was.

[00:30:57] Speaker 02:
And we stand by that.

[00:30:59] Speaker 02:
That's plain and ordinary meaning of what a particle is.

[00:31:01] Speaker 02:
And this is not unlike the Epitalis versus Epitex case where

[00:31:07] Speaker 02:
Again, plain and ordinary meaning.

[00:31:08] Speaker 02:
And this court reversed the district court's findings that a matrix formulation was a coding over a particle.

[00:31:16] Speaker 02:
And said, no, you can't reconcile that plain and ordinary meaning argument with the language, with the file history, with the written description, with this court's background.

[00:31:28] Speaker 02:
You just cannot.

[00:31:29] Speaker 02:
Skip over this particle limitation it is the claim limitation is not Crystals with a d90 of less than 89 microns it is crystalline a pixaban particles with a d90 of less than 89 microns and

[00:32:00] Speaker 01:
There's a little confusion at the end.

[00:32:04] Speaker 01:
And what we're trying to say is the following.

[00:32:08] Speaker 01:
The scope of the claim and how it should be interpreted should be commensurate with the scope of the patent, the bold invention that the examiner found.

[00:32:18] Speaker 01:
And I put forth to you on, I think it's on page of the appendix 264, the very, very last paragraph of the patent, where

[00:32:29] Speaker 01:
it's explained.

[00:32:31] Speaker 01:
Figures 3 and 4 illustrate the dissolution data that shows why particle size impacts dissolution.

[00:32:39] Speaker 01:
Controlling the particle size to less than 89 microns will result in a dissolution rate that will ensure consistent in vivo exposure.

[00:32:49] Speaker 01:
If you look at

[00:32:52] Speaker 01:
Figures three and four, there's nothing in those figures that show a measurement of particle size of formulated epixaban.

[00:33:02] Speaker 01:
What is shown and what was proven as patentable is that figures three and four show the measurement of pre-formulated epixaban.

[00:33:12] Speaker 01:
It's very clear there.

[00:33:14] Speaker 05:
As as it goes on just I gotta keep it fair I didn't realize you had used all your rebuttal time and I've now given you more than a minute and a half in addition so I've got to move it on.

[00:33:24] Speaker 00:
Mr. Pechik Thank you your honor and obviously I'll make it very brief

[00:33:41] Speaker 00:
I would first like to address the point that Mr. Lee made where he said the 945 patent contemplated measuring the dissolution at the site of absorption.

[00:33:53] Speaker 00:
Well, that's just part of the quote that's actually in the patent.

[00:33:56] Speaker 00:
If you continue on, it says the feature of this invention, however, involves the processes that produce a pixaban dosage forms with the ability to produce primary particles at the site of dissolution

[00:34:08] Speaker 00:
with a D90 of less than 89 microns.

[00:34:12] Speaker 00:
That's exactly what we're saying.

[00:34:14] Speaker 00:
This is a tablet, the invention here is a tablet made with a Pixaban having a pre-known D90.

[00:34:21] Speaker 00:
And here, BMS was acting as their own lexicographer with defining the D90, which they did in the specification.

[00:34:28] Speaker 00:
D90 must have a meaning as a claim limitation.

[00:34:31] Speaker 00:
And if the claims are construed to cover both pre-formulated and formulated a Pixaban,

[00:34:38] Speaker 00:
then there is no meaning to the term D90.

[00:34:42] Speaker 00:
Further, written description and enablement must be for the full scope of the claims.

[00:34:46] Speaker 00:
That is, measuring the D90 of both the bulk and the finished.

[00:34:51] Speaker 00:
Here, the 945 patent omits completely the concept of determining the D90 in a tablet.

[00:35:00] Speaker 00:
So that is just not described, nor is it enabled.

[00:35:04] Speaker 00:
So to the extent that BMS or appellees

[00:35:08] Speaker 00:
would like to have claims that cover both the bulk and the formulated pixaban.

[00:35:13] Speaker 00:
Those claims violate section 112 and they simply cannot have their cake and eat it too.

[00:35:20] Speaker 05:
Okay thank you counsel.

[00:35:22] Speaker 05:
I thank all counsel in this case because it's taken under submission.