[00:00:00] Speaker 02:
The next case is Otsuka Pharmaceutical versus Lupin.

[00:00:05] Speaker 02:
Case number 24-2297.

[00:00:07] Speaker 02:
Mr. Garrett, when you're ready.

[00:00:12] Speaker 01:
Good morning, your honors.

[00:00:13] Speaker 01:
May it please the court?

[00:00:14] Speaker 01:
I'd like to begin with infringement.

[00:00:17] Speaker 01:
This case turns on a straightforward legal air.

[00:00:21] Speaker 01:
The court rejected Lupin's claim interpretation, yet it relied on expert testimony predicated on that very interpretation to decide infringement.

[00:00:34] Speaker 01:
In doing so, the court tied completion of the claim reaction to the arbitrary timing of Lupin's quench manufacturing step, rather than on the science itself.

[00:00:47] Speaker 01:
Under the district court's approach,

[00:00:49] Speaker 01:
Infringement can be avoided simply by postponing the quench manufacturing step until after one equivalent has been added, even if the science demonstrates that the reaction had reached completion long before that point in time.

[00:01:06] Speaker 01:
At trial, Lupin interpreted the claims to mean that the reaction continues so long as even a single molecule of ketone or sodium borohydride remain.

[00:01:16] Speaker 01:
Under that view, the reaction will continue even after the ketone content has fallen to 0.00.

[00:01:22] Speaker 02:
Sure, and the district court rejected that as a matter of claim instruction that said it didn't have to be absolute completion.

[00:01:30] Speaker 02:
It had to be

[00:01:31] Speaker 02:
I don't know if he used the word practical completion, but it seems like that's the basic concept here.

[00:01:38] Speaker 02:
But then he concluded as, I'm not sure why I understand this is a legal error.

[00:01:42] Speaker 02:
He concluded as a matter of fact that their reaction hadn't completed before 1.0 was put in.

[00:01:54] Speaker 02:
It's a legal error, Your Honor.

[00:01:56] Speaker 02:
I mean, it might be that it's clear error on infringement, but I don't understand what the legal error is.

[00:02:02] Speaker 01:
It's legal, Your Honor, because the court misapplied the claim construction.

[00:02:07] Speaker 01:
The court stated that it was rejecting Lupin's construction, but then it went on to rely on expert testimony predicated on that very interpretation.

[00:02:21] Speaker 02:
that he had the correct claim construction and his factual conclusion about infringement was wrong because it relied on testimony that went to an improper period of time.

[00:02:41] Speaker 02:
I'm not sure you should get hung up in this legal versus factual error, because it's not a battle that you necessarily need to win.

[00:02:48] Speaker 01:
Understood, Your Honor, and I appreciate that.

[00:02:51] Speaker 01:
I just don't understand.

[00:02:53] Speaker 02:
You're not arguing claim construction error.

[00:02:56] Speaker 02:
We're arguing misapplication of the claim construction.

[00:03:01] Speaker 01:
I'm not sure how that is a legal question.

[00:03:05] Speaker 01:
Well, the case law is clear that misapplications of claim constructions are reviewed just as regular claim constructions decisions are reviewed.

[00:03:17] Speaker 01:
Here, when the reaction reaches completion was the only infringement issue in the case.

[00:03:22] Speaker 01:
Well, that's a factual issue.

[00:03:24] Speaker 01:
Well, it's not.

[00:03:26] Speaker 02:
I think I really, I gave you advice once.

[00:03:28] Speaker 02:
I think you should take it and stop fighting this and explain to me why, as a matter of fact, what he found is incorrect under the claim construction he gave.

[00:03:39] Speaker 01:
Thank you, Your Honor.

[00:03:43] Speaker 01:
The district court's finding is incorrect under either standard, because the evidence demonstrates that the claim reaction is complete before one more chlorine borohydride has been added.

[00:03:59] Speaker 02:
And what's that evidence?

[00:04:01] Speaker 01:
Well, the evidence is multi-fold, Your Honor.

[00:04:03] Speaker 01:
It's super presented data in experiments 109 and 115.

[00:04:07] Speaker 00:
Give us specific JA pages for that.

[00:04:11] Speaker 00:
support for what you think is the best evidence in response to Judge Hughes's question.

[00:04:17] Speaker 01:
Yes, Your Honor.

[00:04:18] Speaker 01:
The evidence demonstrates that the DMF discloses the reaction conditions

[00:04:24] Speaker 01:
The DMF reaction conditions are disclosed at APPX308, APPX312, APPX427.

[00:04:32] Speaker 01:
The evidence also reflects the known sodium borohydride reaction rates.

[00:04:37] Speaker 01:
Dr. Roush was offered and admitted as an expert in sodium borohydride reaction rates without objection over Lupin.

[00:04:48] Speaker 01:
He testified that these reactions proceed very quickly

[00:04:53] Speaker 01:
He explained that based on his experience as well as evidence in the record, once lupin has added 0.25 molar equivalents of sodium borohydride, the reaction will be complete within 30 minutes.

[00:05:08] Speaker 01:
That testimony was uncontroverted.

[00:05:11] Speaker 01:
Dr. Dichtel offered no testimony with respect to when the reaction achieves practical completion.

[00:05:18] Speaker 02:
Is that the testimony that Judge Andrews rejected because the expert didn't actually do any experiments, and it was just his opinion, and it was collusory?

[00:05:30] Speaker 01:
Your Honor, Otsuka did not perform any testing because Otsuka had the evidence to demonstrate infringement even without it.

[00:05:38] Speaker 01:
Lupin performed testing during the development of its DMF.

[00:05:41] Speaker 01:
That's experiments 109 and 115.

[00:05:43] Speaker 01:
The district court dismissed those experiments and then disregarded Dr. Rausch's other testimony.

[00:05:54] Speaker 01:
But even putting aside experiments 109 and 115, Otsuka has met its burden in this case.

[00:06:01] Speaker 01:
We have Dr. Rausch's testimony.

[00:06:03] Speaker 01:
It's not conclusory.

[00:06:05] Speaker 01:
It's based on the DMF reaction conditions.

[00:06:08] Speaker 01:
It's based on the known sodium borohydride reaction rates.

[00:06:11] Speaker 02:
I take it your view is that he didn't actually have to perform experiments because he's an expert in this field.

[00:06:17] Speaker 02:
And based on his experience, he can testify this is what would have happened.

[00:06:21] Speaker 01:
Yes, Your Honor.

[00:06:23] Speaker 01:
And that testimony is grounded in the DMF conditions.

[00:06:27] Speaker 01:
It's grounded in the sodium borohydride reaction rates and his expertise.

[00:06:31] Speaker 01:
And notably, that testimony went uncontroverted.

[00:06:35] Speaker 01:
Again, Dr. Dichtel did not dispute that these reactions proceed very quickly.

[00:06:40] Speaker 01:
He did not dispute that by the time you've added 0.25 molar equivalents, that's what you need for the reaction to go to completion due to the stoichiometry, once you've added that minimum amount,

[00:06:49] Speaker 01:
It'll be complete within 30 minutes.

[00:06:52] Speaker 01:
Dr. Dichtel did not offer any testimony to dispute that conclusion.

[00:06:58] Speaker 01:
So Tsuka has met its burden, even once we set aside experiments 109 and 115.

[00:07:04] Speaker 01:
Dr. Dichtel's testimony

[00:07:10] Speaker 01:
He offered no testimony about when the reaction actually reaches practical completion.

[00:07:14] Speaker 01:
He was focused on when the reaction reaches absolute completion.

[00:07:20] Speaker 01:
And that's exactly what the district court disregarded.

[00:07:24] Speaker 01:
If I can give an example.

[00:07:30] Speaker 01:
At APPX 526 and 527, Dr. Digtel makes clear his belief that the parties were fighting over exactly when the reaction is going to be absolutely stopped.

[00:07:44] Speaker 01:
He thought the parties were fighting over when the reaction absolutely stops.

[00:07:50] Speaker 01:
But that's precisely what the district court rejected.

[00:07:53] Speaker 01:
Dr. Dichtel offered no testimony with respect to when the reaction achieved practical completion.

[00:07:59] Speaker 01:
Dr. Rausch's testimony on that point went unrebutted.

[00:08:05] Speaker 00:
Can you look at that testimony specifically regarding this absolute stopping point?

[00:08:11] Speaker 00:
Because it seems to be one of your key points.

[00:08:13] Speaker 00:
What's the correct pages to look at?

[00:08:15] Speaker 01:
The testimony I just referenced, Your Honor, was at 8PPX 526 and 527.

[00:09:05] Speaker 01:
Your honor, do you have any questions on this testimony?

[00:09:07] Speaker 01:
Would you like me to walk us through it?

[00:09:10] Speaker 00:
I would like you to start walking us through it, and then I will post questions as you're going.

[00:09:15] Speaker 01:
I understood.

[00:09:16] Speaker 01:
Thank you.

[00:09:16] Speaker 00:
I assume you're looking at around line 14 on 526, is that where you're starting?

[00:09:21] Speaker 01:
That's right.

[00:09:22] Speaker 01:
If we started at line 10 on 526, Dr. Dictel, we were looking at a document where Lupin's DMF, which references a completion of reaction, and he was asked that Lupin's scientists are defining completion in reference to completion of reaction as being 0.05, that's ketone content.

[00:09:44] Speaker 01:
That's how Lupin scientists are defining completion.

[00:09:47] Speaker 01:
They're defining it based on practical completion.

[00:09:49] Speaker 01:
And Dr. Dichtel said, I fully agree with that, that that is what it says.

[00:09:56] Speaker 01:
But when this was written, I'm not sure Lupin scientists were anticipating a time that we were going to be fighting over exactly when the reaction was going to be absolutely stopped.

[00:10:10] Speaker 01:
Again, Dr. Dichtel thought the parties were fighting over exactly when the reaction is absolutely stopped, not when it reaches practical completion.

[00:10:21] Speaker 01:
The idea that the reaction stops when it absolutely stops, that's precisely what the district court rejected in its post-trial claim construction at APPX 13 and 14.

[00:10:34] Speaker 00:
So your argument, in part, is just that you believe that Dr. Dittell was applying the wrong construction?

[00:10:41] Speaker 00:
Is that your argument inside?

[00:10:43] Speaker 01:
Yes, Your Honor.

[00:10:44] Speaker 01:
He was providing the wrong construction.

[00:10:47] Speaker 01:
He was providing the construction that the district court rejected in its post-trial decision.

[00:10:53] Speaker 01:
His testimony on completion.

[00:10:55] Speaker 01:
went to absolute completion, not the point at which the reaction reaches practical completion.

[00:11:00] Speaker 01:
Only Dr. Rausch testified on that point.

[00:11:03] Speaker 01:
Dr. Rausch, again, admitted as an expert in inserting borohydride reactions without objection from a movement.

[00:11:10] Speaker 01:
He provided an explanation based on the evidence, based on the DMF itself.

[00:11:16] Speaker 01:
based on sodium borohydride reaction conditions.

[00:11:19] Speaker 01:
And he explained, once you've added 0.25 molar equivalents, the reaction will be done within half an hour.

[00:11:26] Speaker 01:
That is long before Lupin has added one equivalent of sodium borohydride.

[00:11:31] Speaker 02:
Well, I mean, I see what you're saying.

[00:11:34] Speaker 02:
But he is also suggesting that there is basically a disconnect here.

[00:11:40] Speaker 02:
And what we're talking about

[00:11:41] Speaker 02:
is not when the reaction is practically complete, but when the reaction is sufficiently complete that they don't feel that they need to let it play out anymore because it's pure enough and they don't have to, whatever, spend more time doing it.

[00:11:58] Speaker 02:
So how do you explain that?

[00:12:00] Speaker 02:
Because that seems to me a different thing than requiring absolute completion.

[00:12:05] Speaker 02:
for purposes of the claim construction.

[00:12:09] Speaker 02:
I mean, practical completion, and this is what seems to me that Judge Andrews may have gotten, may have agreed with, or I'm having a little confusion here myself, is

[00:12:21] Speaker 02:
You can put in whatever the stuff until it gets a certain level.

[00:12:25] Speaker 02:
And you can stop it whenever you want, right?

[00:12:27] Speaker 02:
It has to reach a certain purity level for all the other claims.

[00:12:31] Speaker 02:
But you just quench it whenever you want.

[00:12:33] Speaker 02:
How does that tie up with practical completion, which is what you're arguing?

[00:12:39] Speaker 02:
I think I understand, Your Honor.

[00:12:41] Speaker 02:
If you don't, don't worry about it.

[00:12:43] Speaker 02:
It seems to me he was testifying that the point in time that we're talking about

[00:12:50] Speaker 02:
is could be after your view of practical completion, because it's just when the company feels like it's OK to move on to the next step.

[00:13:02] Speaker 02:
And that may have been different than when the reaction had reached a certain practical completion state.

[00:13:09] Speaker 02:
It could be later.

[00:13:10] Speaker 02:
It could be earlier.

[00:13:11] Speaker 02:
And how do you?

[00:13:13] Speaker 02:
I don't quite understand this testimony.

[00:13:15] Speaker 02:
I understand how you're trying to portray it.

[00:13:17] Speaker 02:
But I read it, and it's not so clear to me that it says what you're saying it says.

[00:13:22] Speaker 01:
So Dr. Dittell, he believed that the reaction would continue so long as even a single molecule of ketone remained.

[00:13:30] Speaker 02:
Well, that's technically correct.

[00:13:32] Speaker 02:
But it's inconsistent with the practical completion claim construction.

[00:13:36] Speaker 01:
Well, it's not technically correct in the context of these claims.

[00:13:41] Speaker 01:
Again, completion has to be viewed in the context of the claims.

[00:13:45] Speaker 01:
And in the claims, a POSA would conclude the reaction's done by the time you've reached practical completion.

[00:13:51] Speaker 01:
It's done.

[00:13:51] Speaker 01:
Are there trace amounts of ketone?

[00:13:54] Speaker 01:
Maybe.

[00:13:55] Speaker 02:
But would a POSA actually look at this and say the reaction is complete when they decide it's complete enough to do the quenching step?

[00:14:05] Speaker 02:
And is that what that testimony means?

[00:14:07] Speaker 02:
Well, well, well, well, well, well, well, well, well, well, well, well, well, well, well, well, well, well, well, well, well, well, well, well, well, well, well, well, well, well, well, well, well, well, well, well, well, well, well, well, well, well, well, well, well, well, well, well, well, well, well, well, well, well, well, well, well, well, well, well, well, well, well, well, well, well, well, well, well, well, well, well, well, well, well, well, well, well, well, well, well, well, well, well, well, well, well, well, well, well, well, well, well, well, well, well, well, well, well, well, well, well, well, well, well, well, well, well,

[00:14:31] Speaker 02:
and that that's the completion step.

[00:14:33] Speaker 02:
And that's purely not a chemistry step.

[00:14:38] Speaker 02:
It's a kind of money step or a resources step.

[00:14:45] Speaker 02:
I mean, it seems like he's alluding to that a couple of times, too.

[00:14:49] Speaker 02:
I certainly use the word absolute.

[00:14:51] Speaker 02:
But how do I figure out that and if that's correct?

[00:14:57] Speaker 01:
Your Honor.

[00:14:58] Speaker 01:
The testimony that Dr. Dichtelt gave, again, was that the reaction proceeds so long as there is even a single molecule.

[00:15:06] Speaker 02:
But we don't need to argue about that.

[00:15:09] Speaker 02:
Because I think even if you accept that that extreme is not what these claims contemplate, what he's also saying is, sure.

[00:15:18] Speaker 02:
The reaction is maybe substantially complete, but what these patents are talking about is when they feel comfortable moving on to the next step, which to me, I assume he's talking about, it's done enough that we're going to put in the quenching and move on to the next step.

[00:15:33] Speaker 02:
Why isn't that a proper reading of those claims?

[00:15:37] Speaker 01:
Because the quench step, again, is untethered to the actual progress of the reaction.

[00:15:44] Speaker 01:
The crunch step is not based on the actual science of the reaction.

[00:15:48] Speaker 01:
It's not based on when the ketone content has fallen to a certain point.

[00:15:52] Speaker 02:
And your view is that the language and the claims rely on

[00:15:56] Speaker 02:
the chemical process, not the manufacturing process.

[00:16:00] Speaker 01:
Absolutely, Your Honor.

[00:16:01] Speaker 01:
If you look at the claims, it's all about the chemistry.

[00:16:03] Speaker 01:
The reaction here is synthesizing tovaptin by reducing the ketone in order to avoid an undesirable impurity.

[00:16:12] Speaker 01:
When the ketone has been reduced in a practical sense, you have avoided that impurity, regardless of whether you've yet quenched.

[00:16:21] Speaker 01:
You could wait 10 more hours and then quench.

[00:16:23] Speaker 01:
But you've avoided the impurity long ago based on the science.

[00:16:27] Speaker 01:
And the claim isn't practiced at that point in time.

[00:16:30] Speaker 00:
OK.

[00:16:33] Speaker 00:
I guess one question I have.

[00:16:34] Speaker 00:
So there's only a literal infringement claim here, no DOE, right?

[00:16:37] Speaker 01:
That's correct.

[00:16:42] Speaker 02:
Okay, we've asked a lot of questions, so I'll restore all five minutes of your rebuttal.

[00:16:48] Speaker 02:
Mr. Zimmerman, I'll give you 20 minutes if you need all of it, since we gave him extra time.

[00:16:56] Speaker 02:
Don't feel like you have to take it, though.

[00:17:01] Speaker 02:
20.

[00:17:02] Speaker 02:
No, give him 20.

[00:17:04] Speaker 02:
Give him 20.

[00:17:10] Speaker 03:
Thank you, Your Honor.

[00:17:11] Speaker 03:
Good morning.

[00:17:11] Speaker 03:
May it please the Court.

[00:17:13] Speaker 03:
I'd like to turn directly to Judge Andrew's findings on infringement.

[00:17:18] Speaker 03:
And they're found at pages 14 and 15 of the Joint Appendix.

[00:17:23] Speaker 03:
And the first thing he does is adopt the practical completion standpoint, which Atsuka argued for.

[00:17:30] Speaker 03:
And then he adopts Dr. Rausche's interpretation, if you will, of that construction.

[00:17:37] Speaker 03:
And that is

[00:17:40] Speaker 03:
the moment when an experimentalist decides the reaction is done and wants to work it out.

[00:17:46] Speaker 03:
And that's consistent with Dr. Rausch's testimony at A381, lines 4 through 9, that completion – it's complete when I've decided to proactively stop it.

[00:17:58] Speaker 03:
And Dr. Rausch said it again at page 370, lines 4 through 20.

[00:18:05] Speaker 03:
And it's complete when an experimentalist decides it's done and wants to work it out.

[00:18:09] Speaker 03:
So under Atsuka's construction, the judge looked at the reaction and said, when does lupin work it out?

[00:18:16] Speaker 03:
It was undisputed that they work it up after they put in 1.2 molar equivalents of sodium borohydride and proceed to the quench step.

[00:18:26] Speaker 03:
And that's undisputed.

[00:18:28] Speaker 03:
If that's the analysis, and we don't believe that's clearly erroneous, then the 1.2 molar equivalence is outside of the claim, and there's no infringement.

[00:18:39] Speaker 00:
But judge.

[00:18:39] Speaker 00:
Does the clinical process, though, does it reach practical completion before we hit one?

[00:18:44] Speaker 03:
So that was the next piece Judge Andrews addressed.

[00:18:48] Speaker 03:
And he said, okay, what is the number for practical completion?

[00:18:53] Speaker 03:
Lupin runs an in-process quality check, and the standard is when the ketone precursor level is 0.05 percent.

[00:19:03] Speaker 03:
And if they pass, then they go to the quench step.

[00:19:07] Speaker 03:
But the testimony, which was undisputed, Rausch, Atsuka's expert at

[00:19:15] Speaker 03:
A380, lines 11 through 17, and A387, lines 3 through 9, admits that the reaction goes past that .05 percent standard.

[00:19:29] Speaker 03:
So that can't be the standard.

[00:19:31] Speaker 03:
And if you look at A2285,

[00:19:34] Speaker 03:
Lupin did three exhibit batches and ran the in-process quality check, and they all showed zero or none detected, meaning the reaction goes past this .05 percent level.

[00:19:48] Speaker 03:
And Judge Andrews said the .05 percent level is just an arbitrary standard where it's complete enough to move on.

[00:19:57] Speaker 02:
But then he went on to say that it's at the bottom of the five standard because of the claims.

[00:20:03] Speaker 02:
What was that?

[00:20:04] Speaker 02:
Isn't that because the claims require it to be 99.5% pure?

[00:20:11] Speaker 02:
Why they stop at the 0.05%?

[00:20:14] Speaker 02:
Or the 0.05%.

[00:20:15] Speaker 02:
Here's the problem I'm having with this and your argument is it seems the claims talk about a certain purity level.

[00:20:23] Speaker 02:
That happens.

[00:20:25] Speaker 02:
at a certain point in time, not when you decide to check it.

[00:20:29] Speaker 02:
Right?

[00:20:29] Speaker 02:
Yes.

[00:20:30] Speaker 02:
You didn't claim this as 99.5% when it's successfully tested by our chemist or something.

[00:20:40] Speaker 02:
So if, and I don't know what the answer is to this, but hypothetically, it reaches that level of purity before

[00:20:51] Speaker 02:
it goes all the way to 1.2, then why doesn't it infringe?

[00:20:56] Speaker 03:
And here's what Judge Andrews said.

[00:20:58] Speaker 03:
It's at the bottom of A14.

[00:21:01] Speaker 03:
Even assuming Lupin's reduction reaction reaches practical completion by the 0.05% ketone level, Atsuka fails to show that no more than one molar equivalent of sodium borohydride had been added by that point.

[00:21:18] Speaker 03:
It's a failure of proof case in that they can't show you any evidence that it reaches completion before the full 1.2 as opposed to the 1.

[00:21:29] Speaker 02:
What about the testimony that it definitely would have reached completion

[00:21:35] Speaker 02:
well before the one was added.

[00:21:38] Speaker 03:
So that testimony is all based on Experiments 109 and 115.

[00:21:45] Speaker 03:
And when you look at those on page 15 of the opinion, Judge Andrews says

[00:21:50] Speaker 03:
Those were run with a different ketone precursor level, a different sodium borohydride level, a different pH, a different temperature.

[00:21:58] Speaker 02:
I get that.

[00:21:59] Speaker 02:
To the extent it was based only on that, I think you're right.

[00:22:02] Speaker 02:
What about the fact that it's just based upon the expert's knowledge of basic chemistry principles?

[00:22:08] Speaker 02:
Why isn't that sufficient?

[00:22:09] Speaker 03:
There is no statement.

[00:22:12] Speaker 03:
His statements that O will be done by 0.5 were based on experiments 109 and 115.

[00:22:19] Speaker 03:
He said, O, the DMF process will be four times faster than this experiment.

[00:22:24] Speaker 03:
eight and a half times faster than this one.

[00:22:27] Speaker 03:
But those experiments Judge Andrews found, and the record fully supports, were subject to a margin of error.

[00:22:34] Speaker 03:
They had anomalies in them.

[00:22:35] Speaker 00:
What's the best J.E.

[00:22:37] Speaker 00:
page we could look at to see that everything has to fundamentally rely on experiments 109 and 115?

[00:22:45] Speaker 00:
Because that seems to be what you're telling us in response to Judge Hughes's question.

[00:22:51] Speaker 03:
Give me one moment, Your Honor.

[00:23:04] Speaker 03:
So if you look at Joint Appendix 1981 through 94, this is the post-trial briefing from Atsuka.

[00:23:30] Speaker 03:
And it starts at

[00:23:33] Speaker 03:
Let me get you a pin site.

[00:23:40] Speaker 03:
1991.

[00:23:45] Speaker 03:
If you look at what they argued, the infringement argument starts.

[00:23:54] Speaker 03:
The data demonstrate that Lincoln's process comprises reducing the ketone precursor in the presence of a claimed amount of sodium borohydride.

[00:24:02] Speaker 03:
That's the heading.

[00:24:03] Speaker 03:
on 1991, and they start off right there with experiments 109 and 115.

[00:24:10] Speaker 03:
There is no independent argument that on Rausch's say-so, we infringe.

[00:24:20] Speaker 03:
That is only an argument you find on appeal.

[00:24:22] Speaker 03:
They never made that argument below.

[00:24:28] Speaker 03:
And you'll see what Rausch did is he said,

[00:24:32] Speaker 03:
In experiments 109 and 115, it's complete when you add 0.91 molar equivalents, even though it's different conditions, different pH, different scale.

[00:24:44] Speaker 03:
And then Roush goes on to testify that, based on that,

[00:24:49] Speaker 03:
then the DMF process will also infringe.

[00:24:52] Speaker 03:
They never made any independent argument that, oh, we know it's 0.5 based on just known reaction rates and known chemistry.

[00:25:04] Speaker 03:
It's all tied to 109 and 115.

[00:25:11] Speaker 03:
And if I could, just for the record.

[00:25:15] Speaker 02:
So let me ask you this.

[00:25:21] Speaker 02:
Let's assume that whatever I conclude about claim construction and stuff, I find Dr. Dichtel's testimony insufficient, that I read it as either the absolute completion theory, which

[00:25:38] Speaker 02:
the district court already had rejected, to the extent it was putting that in, it's unreliable and infringement.

[00:25:44] Speaker 02:
So you couldn't argue it.

[00:25:46] Speaker 02:
Or that he's somehow arguing that the process is complete when you do the quenching step and check the thing.

[00:25:53] Speaker 02:
And that also I find insufficient, because it could reach the purity level far before that.

[00:25:59] Speaker 02:
So if I throw out all of that stuff,

[00:26:02] Speaker 02:
all of that testimony, what remains to support the district court's infringement?

[00:26:09] Speaker 02:
A lack of infringement.

[00:26:10] Speaker 02:
Or whichever it is.

[00:26:13] Speaker 02:
Lack of infringement.

[00:26:14] Speaker 03:
The district courts, we disagree with the premise.

[00:26:17] Speaker 02:
I understand.

[00:26:17] Speaker 03:
I'm asking a hypothetical.

[00:26:19] Speaker 03:
In that, it's still a failure of proof.

[00:26:23] Speaker 03:
Because Judge Andrews said experiments 109 and 115 aren't reliable.

[00:26:28] Speaker 03:
That finding is not clearly erroneous.

[00:26:31] Speaker 03:
And Plano's other testimony is based on those two experiments, which the judge said is unreliable.

[00:26:38] Speaker 02:
And it's their burden.

[00:26:39] Speaker 03:
And it's their burdens.

[00:26:41] Speaker 03:
And they did no testing.

[00:26:43] Speaker 03:
So we're in this world where they're saying Dr. Dichtel is insufficient.

[00:26:49] Speaker 03:
But the judge didn't just rely on Dr. Dichtel.

[00:26:52] Speaker 03:
He said, even if I give you your 0.05% cutoff, even if we look at it from your lens through your claim construction, which is unchallenged, you haven't met your burden.

[00:27:03] Speaker 03:
And the record clearly supports that.

[00:27:05] Speaker 02:
OK.

[00:27:06] Speaker 02:
Can you point to me where he clearly made that as an alternative holding?

[00:27:09] Speaker 02:
Because I really see his findings on this.

[00:27:12] Speaker 02:
as relying a lot on what Dr. Dichtel said.

[00:27:16] Speaker 02:
And if I conclude that Dr. Dichtel's testimony is unreliable under a bunch of reasons, if his factual findings are infected by that, don't I at least have to send it back and say you can't consider this testimony for this purpose?

[00:27:31] Speaker 03:
Well, so twofold.

[00:27:33] Speaker 03:
Page A14, at the bottom of the page,

[00:27:37] Speaker 03:
is his finding that even assuming Lupin's reduction reaction reaches practical completion at the 0.05 percent ketone precursor level, Atsuka fails to show that no more than one molar equivalent of sodium borohydride has been added by that point.

[00:27:53] Speaker 03:
That's an express finding by the judge.

[00:27:56] Speaker 03:
And then on the next page... What does he cite to you for that?

[00:28:01] Speaker 02:
He doesn't really cite anything.

[00:28:02] Speaker 02:
What's that based on?

[00:28:04] Speaker 03:
That's based on his review of the entirety of the evidence and.

[00:28:08] Speaker 02:
Including Dr. Dichtel's testimony?

[00:28:12] Speaker 03:
No.

[00:28:12] Speaker 03:
No.

[00:28:13] Speaker 03:
He says Atsuka has failed to show.

[00:28:16] Speaker 03:
So their affirmative proofs indicate in that question.

[00:28:19] Speaker 03:
And then on the next page, he throws out 109 and 115.

[00:28:23] Speaker 03:
On the issue of Dichtel, though, the testimony that was pointed to on 526 about absolute completion

[00:28:33] Speaker 03:
Dr. Dichtel says that the reaction continues after the 0.05% threshold in Lupin's test.

[00:28:42] Speaker 03:
That's undisputed.

[00:28:44] Speaker 03:
And 2285 are the test results that actually show it goes to an undetectable level.

[00:28:52] Speaker 03:
The absolute completion theory comes from Atsuko's post-trial brief.

[00:28:59] Speaker 03:
where they tried to cast that on Dichtel based on how they crossed him.

[00:29:03] Speaker 03:
The other important point to note, though, there is an express finding of waiver by the district court judge with respect to their challenge to Dr. Dichtel.

[00:29:15] Speaker 03:
They did not object to any of his testimony at trial at all.

[00:29:21] Speaker 02:
Right.

[00:29:21] Speaker 02:
I understand.

[00:29:22] Speaker 02:
To the extent there's some kind of, like, post-hoc-doubter challenge, we're not going to look at that.

[00:29:27] Speaker 02:
I'm just determining whether I think his testimony is completely unreliable, because it proceeds under a claim construction.

[00:29:35] Speaker 02:
So therefore, it can't be evidence, not that it should have been excluded.

[00:29:38] Speaker 03:
No.

[00:29:39] Speaker 03:
His testimony is from a scientific standpoint, where he tells you, here's how the reaction proceeds.

[00:29:45] Speaker 03:
But then from a chemistry standpoint, it continues on.

[00:29:50] Speaker 03:
But that second piece doesn't matter, because the judge said, even if I set the practical completion at 0.05%, as Atsuka argues, there's no evidence in the record that that happens before one molar equivalent.

[00:30:06] Speaker 00:
Let me put down a few different questions for you on this front.

[00:30:10] Speaker 00:
So it sounds like part of your argument is that if we throw out Dr. Digtel's testimony for any variety of reasons, there's still enough in the record to say that you still would get the finding of no infringement based off of what is included with these two experiments and also Dr. Walsh's testimony.

[00:30:30] Speaker 03:
Is that what you're saying?

[00:30:32] Speaker 03:
Yes.

[00:30:33] Speaker 03:
They will still have a failure of proof

[00:30:36] Speaker 03:
because the .05 cutoff that they're arguing for, their expert says the reaction proceeds past that point.

[00:30:44] Speaker 03:
80-22-85 shows you it progresses past that point.

[00:30:49] Speaker 03:
And the judge has an express finding that they have no evidence that shows it happens before one.

[00:30:56] Speaker 03:
They rely on the experiments.

[00:30:59] Speaker 03:
And in criticizing Experiments 109 and 115, and I think this is important, the judge didn't rely on Dichtel's testimony.

[00:31:09] Speaker 03:
He relied on Rausch's testimony, their expert.

[00:31:13] Speaker 03:
And if you look at A325, 14 through 25, and A359, 10 through 23,

[00:31:25] Speaker 03:
And I'll walk you through both of these.

[00:31:27] Speaker 03:
And this is Dr. Rausch's testimony.

[00:31:36] Speaker 03:
And it's actually 324 and 325.

[00:31:38] Speaker 03:
Dr. Rausch is talking about the experiment and says that that represents a margin of error.

[00:31:48] Speaker 03:
And he was explaining

[00:31:51] Speaker 03:
It's an irreversible reaction, so the ketone precursor level should go down over time.

[00:31:57] Speaker 03:
In experiment 115, the reported results go down and then back up, which is physically impossible.

[00:32:04] Speaker 03:
So Dr. Rausch says this must be a margin of error in the measurements.

[00:32:10] Speaker 03:
And then at 359, 10 through 23,

[00:32:21] Speaker 03:
On cross-examination, Dr. Rausch admitted, and it's at lines 20 and 21, that these experiments hadn't been put through an appropriate level of quality control.

[00:32:31] Speaker 03:
They were one-off experiments.

[00:32:34] Speaker 03:
And so based on Rausch's own testimony, the judge says these two experiments are unreliable.

[00:32:42] Speaker 02:
That fact-finding.

[00:32:43] Speaker 02:
Can I ask you to look at 344 and 345?

[00:32:45] Speaker 03:
344?

[00:32:48] Speaker 03:
Yes.

[00:32:49] Speaker 02:
Are these testimonies about those experiments, too?

[00:32:52] Speaker 02:
Are these more general statements from Dr. Rausch that he believes that the reaction would have been complete before Lupin adds 0.5 molar equivalents?

[00:33:06] Speaker 02:
So starting using where I am, basically the middle of the page.

[00:33:11] Speaker 02:
Yes, line 16.

[00:33:13] Speaker 02:
Yeah, he's saying that this is going to happen in this time frame.

[00:33:18] Speaker 02:
And then he's asked, did the experiments support this?

[00:33:22] Speaker 02:
And even if I agree with you on the experiment, is this testimony from about line 16 to about line 6?

[00:33:30] Speaker 02:
on 345 based only on those experiments, or is it based upon his kind of independent knowledge of how chemistry works and this process would work?

[00:33:41] Speaker 03:
That testimony, in context, he drew a graph.

[00:33:45] Speaker 03:
And the graph is a slide, yeah.

[00:33:49] Speaker 03:
Yes.

[00:33:50] Speaker 03:
Somewhere in the 4,000-year-old.

[00:33:53] Speaker 02:
Can you answer that question first?

[00:33:55] Speaker 02:
Is this testimony infected by the experiments, or is this kind of independent testimony?

[00:34:03] Speaker 03:
And I'm doing both.

[00:34:06] Speaker 03:
The graph is at 4220.

[00:34:09] Speaker 03:
And that graph is based on the experiments.

[00:34:16] Speaker 03:
Like, his entire testimony about these amounts, he has no – he proffered no reaction rates, separate and apart from experiments 109 and 115.

[00:34:31] Speaker 03:
Like, whatever his expertise is, he can't just say, well, it's my opinion that it's done by 0.5, with no reaction rates, no accounting for temperature, scale, any of that.

[00:34:45] Speaker 00:
How do we know that appendix page 4220 is based on the experiments?

[00:34:49] Speaker 00:
How do we know that?

[00:34:50] Speaker 03:
Um.

[00:34:52] Speaker 00:
Does it pull it up?

[00:34:56] Speaker 03:
Give me one second to get back there.

[00:34:59] Speaker 03:
I believe that slide.

[00:35:15] Speaker 03:
My belief, Your Honor, is that this is slide 34, PTX.

[00:35:24] Speaker 00:
Yes, but I'm basically asking a variant of the question Judge Hughes asked you to.

[00:35:30] Speaker 00:
Yeah.

[00:35:30] Speaker 00:
How do I know that this slide is based on the experiments as opposed to being somehow independent?

[00:35:38] Speaker 03:
He testifies at page 344.

[00:35:43] Speaker 03:
Looking at this slide, it's line 16.

[00:35:46] Speaker 03:
Slide 34.

[00:35:53] Speaker 03:
And as I stand here, I don't have the marking that says it's slide 34.

[00:35:58] Speaker 02:
Well, even if it is slide 34, I don't see that it's necessarily connected to the experiment.

[00:36:06] Speaker 00:
That's what I'm trying to understand, too.

[00:36:08] Speaker ?:
Right.

[00:36:08] Speaker 00:
I think that he and I are moving the same page.

[00:36:10] Speaker 02:
But if it's connected to the experiments, I understand your argument.

[00:36:14] Speaker 02:
What I'm trying to get at is, and let's just start with the proposition that is testimony on 344 or 45 that we're looking at.

[00:36:21] Speaker 02:
And this slide isn't connected to the experiments, but is somehow based on his independent knowledge as an expert witness, which he's qualified to testify on.

[00:36:33] Speaker 02:
Why isn't that evidence that?

[00:36:37] Speaker 02:
is sufficient to consider.

[00:36:39] Speaker 02:
I think the district court just said this is conclusory.

[00:36:42] Speaker 02:
I don't see it as conclusory at all.

[00:36:44] Speaker 03:
Well, he did no analysis of the reaction weight, the temperature, the scale, the amount of sodium borohydride.

[00:36:56] Speaker 03:
All of that was done in connection with experiments 109 and 115, where he says fourfold faster, eightfold faster,

[00:37:06] Speaker 03:
He has no experiments to say, this is how fast the actual DMS process could go.

[00:37:12] Speaker 03:
And to be an expert and go, well, based on my experience, it's done by 0.5, and that happens to be the claim number.

[00:37:20] Speaker 03:
It isn't the kind of science that you need to carry your burden.

[00:37:26] Speaker 03:
And the district court didn't credit that, even if it's separate and apart.

[00:37:31] Speaker 03:
Judge Andrews didn't credit it.

[00:37:33] Speaker 03:
And he sat through the entire trial.

[00:37:36] Speaker 03:
He listened to all of the evidence.

[00:37:38] Speaker 03:
And this is not a case where they're saying one particular fact finding is clearly erroneous.

[00:37:45] Speaker 03:
When you look at the brief, Atsuka's position is that almost every finding he made on unexpected results on obviousness is clearly erroneous.

[00:37:54] Speaker 03:
Almost every finding he made on the infringement issue is clearly arrears.

[00:37:59] Speaker 03:
This is a seasoned trial judge who heard all of the evidence and made credibility determinations and factual findings that don't leave you with a firm conviction that he made a mistake.

[00:38:12] Speaker 00:
So part of your answer to Judge Hughes's question is that these two pages we were looking at, 344 to 45, won't relied on by Judge Andrews in reaching his final.

[00:38:23] Speaker 00:
Conclusion is that part of your answer?

[00:38:26] Speaker 03:
Give me one second.

[00:38:28] Speaker 03:
I need to check if he cited 109.

[00:38:31] Speaker 03:
109.

[00:38:38] Speaker 03:
The appendix numbers at 345 have a trial transcript page number at the top.

[00:38:45] Speaker 03:
And Judge Andrews' opinion uses the trial transcript.

[00:38:48] Speaker 00:
You got to translate it to the JA pages.

[00:38:50] Speaker 00:
I understand what you're saying.

[00:38:51] Speaker 00:
Let me ask you one final question, because I know we're over time, and I want to wrap up.

[00:38:56] Speaker 00:
I have at least some concerns about Dr. Diktel in terms of the response to the Kyocera opinion, and whether or not he would have qualified

[00:39:09] Speaker 03:
Okay, so that argument that they make with respect to Kiyosera and Dr. Dichtel, if you look at, I want to make sure I get the page number right, A, 1990 to 91, and 2057 to 58.

[00:39:32] Speaker 03:
It's Hatsuka's post-trial brief.

[00:39:37] Speaker 03:
These are the exact arguments that Judge Andrews said were waived.

[00:39:44] Speaker 03:
And for the first time in my history of doing this, I actually printed out a federal rule.

[00:39:50] Speaker 03:
103?

[00:39:52] Speaker 03:
Went back and looked to see, Judge Andrews cited rule 103A.

[00:39:57] Speaker 03:
And the rule says, if a ruler admits evidence, a party on the record must timely object or move to strike

[00:40:07] Speaker 03:
and state the specific grounds of the objection where they can't claim error on appeal.

[00:40:13] Speaker 03:
And the question I would have for counsel, where in the record is that specific objection?

[00:40:21] Speaker 03:
There is not one objection during Dr. Dichtel's testimony.

[00:40:26] Speaker 03:
And the court's finding of waiver, which is reviewed for abuse of discretion, clearly meets the rule.

[00:40:32] Speaker 03:
And the only thing they can point to is a vague statement, an opening statement, that Dr. Dichtel doesn't qualify as a postdoc.

[00:40:41] Speaker 03:
But they waived any right to object by not bringing it up when his testimony was submitted.

[00:40:46] Speaker 02:
OK.

[00:40:46] Speaker 02:
We've gone even more on the extra time.

[00:40:49] Speaker 03:
Thank you, Your Honor.

[00:40:50] Speaker 03:
I appreciate the time.

[00:40:56] Speaker 02:
I'm going to keep it at five minutes, but if we need it, he went over too, so we'll take it.

[00:41:01] Speaker 02:
I appreciate that.

[00:41:01] Speaker 02:
Can you just hone in on this, what we were discussing with him about the Roush testimony on 344 and 45 in this slide, and whether that is

[00:41:16] Speaker 02:
connected to, let's just assume for this that I think that the district court was right to say all those, those two experiments aren't relevant, they were different, so to the extent Roush relied on those, that evidence is out.

[00:41:29] Speaker 02:
Is it, my one question is, is that evidence on 344 and 345 and the slide connected to that, or is it apart from that?

[00:41:40] Speaker 01:
Dr. Rauch gave testimony on 109 and 115, and also testimony separate and apart from that.

[00:41:48] Speaker 01:
If we could look, Your Honor, at 4223.

[00:42:06] Speaker 01:
This is Dr. Rausch's demonstrative, where he's setting forth his opinions.

[00:42:11] Speaker 01:
0.1 is that Lupin's reaction proceeds quickly, such that the reduction is complete before one molar equivalent is added.

[00:42:19] Speaker 01:
And 0.2 is that Lupin's data shows that the reaction is complete by at least, by the time 0.91 molar equivalent is added.

[00:42:27] Speaker 01:
He was making... What data is he relying on?

[00:42:30] Speaker 01:
That data you're on is experiments 109 and 115.

[00:42:32] Speaker 01:
But that's the data that he said wasn't the same.

[00:42:37] Speaker 01:
Well, precisely.

[00:42:38] Speaker 01:
My point is, number one...

[00:42:43] Speaker 02:
Dr. Rauch separates his opinions here.

[00:42:45] Speaker 02:
I'm a little curious as to why you're pointing me that page when I ask you about the other pages which seem not necessarily connected to those experiments.

[00:42:56] Speaker 02:
Is it because that's all part of the same testimony?

[00:42:58] Speaker 02:
It's all connected?

[00:42:58] Speaker 01:
No, no, I was just going to get there.

[00:43:00] Speaker 01:
In 4223, Dr. Rausch explicitly separates his opinions.

[00:43:06] Speaker 01:
First, he says Lupin's reaction proceeds quickly, and that's why they infringe.

[00:43:11] Speaker 01:
And then he says separately, there's data that also confirms that.

[00:43:15] Speaker 01:
They are separate.

[00:43:17] Speaker 01:
And then, if you're not already pointing that out, let me... 4220, so 4223.

[00:43:23] Speaker 02:
Yes.

[00:43:25] Speaker 02:
When you say 0.2,

[00:43:31] Speaker 02:
is relying on the experiment.

[00:43:33] Speaker 02:
The data he's relying on is experiments.

[00:43:36] Speaker 02:
If I find those experiments, like Judge Andrews found, are not relevant because they're different, then how does that 0.2 not infect this whole slide?

[00:43:45] Speaker 01:
Well, these are separate points.

[00:43:47] Speaker 01:
You strike 0.2, you're still left with 0.1.

[00:43:50] Speaker 01:
And that's consistent with Dr. Rausch's testimony, but that's super conclusive.

[00:43:53] Speaker 00:
How do you know that 0.1 doesn't rely on experiments 109 and 115?

[00:43:56] Speaker 01:
And it's super conclusory, too.

[00:43:58] Speaker 01:
Well, it's not conclusory, Your Honors, because Dr. Rauch explained that he was assessing the DMF reaction conditions with the known saline borohydride reaction rates to confirm when the reaction reached completion.

[00:44:12] Speaker 00:
But then... But not a better statement.

[00:44:15] Speaker 00:
It sounds like appendix H4223 is a summary slide.

[00:44:18] Speaker 00:
So what might have been helpful for our purposes is to see the slides immediately proceeding.

[00:44:24] Speaker 00:
Because it looks like there's a gap here, which is probably why Judge Hussner and I are asking you so many questions about whether or not some of these things depend on Experiments 109 and 115.

[00:44:34] Speaker 01:
The point I was trying to make, Your Honors, is that Dr. Roush's testimony, he offered two separate opinions.

[00:44:40] Speaker 01:
He was not offering testimony just on Experiments 109 and 115.

[00:44:44] Speaker 00:
Is there something he confirms, too, to show it's a separate opinion besides this slide, Appendix 109?

[00:44:49] Speaker 01:
Not in his slides, Your Honors, but there is.

[00:44:50] Speaker 00:
Well, I mean, I'll take anything right now.

[00:44:52] Speaker 00:
I don't care if it's a slide or if it's almost something from the moon right now, but can you point me to something different besides slide 4223 to show that he had two separate opinions?

[00:45:03] Speaker 00:
Because right now it all seems to be infected, especially by experiments 109 and 115.

[00:45:19] Speaker 01:
So is testimony explaining that slide, Your Honor, or is it 310 and 311?

[00:45:23] Speaker 01:
APPX 310, 311.

[00:45:24] Speaker 01:
He essentially goes over the slide mentioning 12 points.

[00:45:29] Speaker 01:
APPX 314 through 317 is where Dr. Rauch provides additional testimony on how quickly these reactions proceed.

[00:45:45] Speaker 01:
Dr. Rauch points to the fact that Lupin's DMF permits the sodium borohydride to be added in as little as 30 minutes, plus a 15-minute stir time, demonstrating that, reflecting that the reaction proceeds very quickly.

[00:46:15] Speaker 02:
Anything else?

[00:46:17] Speaker 01:
Yes, Your Honor.

[00:46:27] Speaker 01:
APP at 344 and 345.

[00:46:30] Speaker 01:
That's where Dr. Roush explains that once you've added 0.25 equivalents, the reaction will proceed extremely quickly and be complete within 30 minutes.

[00:46:38] Speaker 02:
And how are we to understand all this testimony is independent work and not interwoven with his reliance on experiments 109 and 115?

[00:46:52] Speaker 01:
That's what the record shows, Your Honor.

[00:46:54] Speaker 01:
At the very least, the decision needs to be vacated and remanded for further proceedings on this point.

[00:46:58] Speaker 01:
I also want to make one other point on 109 and 115.

[00:47:02] Speaker 01:
Dr. Dichtel did testify about those experiments.

[00:47:05] Speaker 01:
He provided testimony that those experiments don't show completion based on his understanding of completion.

[00:47:12] Speaker 01:
And the district court cited that testimony at APPX 15, cited that testimony several times.

[00:47:18] Speaker 00:
Opposing counsel point us to parts of your post-trial brief that really seem to show that all of the infringement evidence was interwoven with experiments 109 and 115.

[00:47:29] Speaker 00:
Is there a different part of your post-trial brief that you want to point us to that did not depend on experiments 109 and 115?

[00:47:38] Speaker 00:
And if the answer is you don't have it, you can say I don't have it.

[00:47:44] Speaker 01:
Your Honor, we were only given 10 pages in the post trial brief, so we had to be very succinct.

[00:47:49] Speaker 01:
We made the argument at trial.

[00:47:50] Speaker 01:
In the post trial brief, APPX 19, I believe it was 1985, Mr. Zimmerman, at the last sentence, he pointed to

[00:48:05] Speaker 01:
a sentence that begins under this construction, and Lupin infringes the assorted patents.

[00:48:09] Speaker 01:
Then it goes on to say Lupin synthesizes tovapin by uniformly adding 1.2 molar equivalents of sorting borohydride over 30 to 240 minutes into the reactor containing TLV3.

[00:48:20] Speaker 01:
And the data demonstrates the reaction reaches completion.

[00:48:24] Speaker 01:
So Mr. Zimmerman only focused on that second part of the sentence, not the first part, which is based on the DMF reaction conditions.

[00:48:31] Speaker 01:
And that's what Roush's testimony on why it reaches completion so quickly was based on.

[00:48:36] Speaker 01:
It was based on those reaction conditions.

[00:48:40] Speaker 02:
Thank you.

[00:48:41] Speaker 02:
You have way over time.

[00:48:42] Speaker 01:
Understood.

[00:48:43] Speaker 02:
Thank you, Your Honors.

[00:48:43] Speaker 02:
Case is submitted.