[00:00:01] Speaker 00:
We have four argued cases this morning.

[00:00:04] Speaker 00:
The first of these is number 151131, Pfizer, Inc.

[00:00:08] Speaker 00:
versus Mylan Pharmaceuticals.

[00:00:11] Speaker 00:
Mr. Karsten.

[00:00:13] Speaker 04:
Good morning, Your Honor.

[00:00:14] Speaker 04:
May it please the Court.

[00:00:16] Speaker 04:
I think I'd like to begin by identifying what it is the issue is on appeal and what's not being appealed.

[00:00:23] Speaker 04:
We're appealing the lower court judgment

[00:00:26] Speaker 04:
relating to the application of the Merck versus BioCraft case.

[00:00:32] Speaker 04:
We're not appealing the findings under Otsuka for the lead compound analysis.

[00:00:40] Speaker 04:
Under Otsuka, Pfizer's brief, for example, really does focus in on the lead compound aspects as opposed to addressing the actual issue on appeal, which is the Merck versus BioCraft case.

[00:00:54] Speaker 04:
We submit that

[00:00:56] Speaker 04:
In the chemical arts, there are multiple ways to prove obviousness.

[00:01:01] Speaker 04:
It's not limited to just a lead compound analysis.

[00:01:04] Speaker 00:
But even if that's true, it seems to me that you have real problems with Judge Sleet's findings, who found that it wasn't obvious to go from dimethyls adenogenib to adenogenib, and also found that it wasn't obvious to go from there to the salt.

[00:01:26] Speaker 04:
Those are the two factual findings that we believe Judge Sleeve committed clear error.

[00:01:31] Speaker 04:
The remainder of the factual findings, many of which Pfizer amplifies and relies heavily upon in its brief, are not relevant to this appeal.

[00:01:41] Speaker 04:
With respect to the dimethyl to diethyl conversion, one need look no further than the four corners of the 422 patent.

[00:01:50] Speaker 04:
Now, under the Merck analysis, you've got a combination.

[00:01:54] Speaker 04:
aldehydes and oxyendols, about 1,200 possible combinations to generate a structure of Formula 1.

[00:02:03] Speaker 01:
But your problem, same problem, is that the district court found certain expert testimony persuasive that the posita would not have replaced the dimethylene group with a diethylamine group.

[00:02:22] Speaker 01:
if faced with a decaliation problem.

[00:02:26] Speaker 04:
Yes, Your Honor.

[00:02:26] Speaker 04:
So when one gets to the dimethyl compound from that group of 1,200, we submit its routine experimentation to go from the dimethyl to the diethyl.

[00:02:39] Speaker 04:
And the reason is found in the 422 patents.

[00:02:43] Speaker 00:
But you're challenging his fact findings there.

[00:02:46] Speaker 01:
And we admit it.

[00:02:47] Speaker 01:
But he believed an expert who said otherwise.

[00:02:51] Speaker 04:
The expert in question said that conversion to the diethyl may not solve the dealkylation problem, but that doesn't change that there may well be a reasonable expectation of success.

[00:03:07] Speaker 04:
And that's what we're talking about with respect to obviousness here.

[00:03:11] Speaker 04:
So the 422 patent application itself says that of the alkyl groups, of which methyl is one,

[00:03:20] Speaker 04:
that most preferred are a group of C1 through C4, the so-called lower alkyl.

[00:03:25] Speaker 04:
And that is found within the four corners of the 422 application, A3075 lines 1 through 2.

[00:03:35] Speaker 04:
A person of ordinary skill in the art expects or understands, and there's testimony exactly to this effect, that dealkylation may well be a problem.

[00:03:44] Speaker 04:
And it's routine experimentation to see what the patent application itself teaches.

[00:03:50] Speaker 04:
in terms of determining a possible or a potential solution to the problem that, while it may not work, there is unpredictability in the art.

[00:03:58] Speaker 04:
We recognize that.

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And that's what Judge Sleep was talking about.

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That doesn't change the fact that there could well be, and there was in this case, testimony about an expectation of success based within the four corners of the 422 application itself.

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And that's why we submit that Merck applies.

[00:04:17] Speaker 04:
In fact,

[00:04:18] Speaker 04:
Judge Sleet's legal test under the Merck analysis really amounts to about two lines in the opinion.

[00:04:29] Speaker 04:
And we believe that the legal test as applied by Judge Sleet was tainted with the Atsuka lead compound analysis.

[00:04:37] Speaker 04:
Atsuka itself says and recognizes that new compounds may be created from theoretical considerations.

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rather than from attempts to improve on prior arc compounds.

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It doesn't require.

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There's a separate obviousness line when you're dealing not with synthesized and studied and disclosed information about prior arc compounds.

[00:05:04] Speaker 04:
When you're doing that, then Atsuka says ordinarily you use a lead compound analysis.

[00:05:12] Speaker 04:
We submit that Merck itself remains good law.

[00:05:16] Speaker 04:
And the more time that one spends with the prior Art 813 patent that invalidated the patent that was at issue in Merck, the more one recognizes how close and similar this case is to the Merck case.

[00:05:35] Speaker 04:
When one looks at the Merck decision, for example, and one reads Judge Bissell's dissent, that dissent could well have been written, Your Honors,

[00:05:46] Speaker 04:
about Judge Sleece's opinion here.

[00:05:48] Speaker 04:
But that didn't alter the fact that this court found the patent at issue in Merck obvious.

[00:05:58] Speaker 04:
Just as we submit here, the one single Four Corners reference, this near-miss anticipation, should render the asserted patents and the claims that Pfizer asserted against Miland here obvious.

[00:06:13] Speaker 04:
And Judge Dyke, with respect to the salt selection, we submit that the district court committed clear error in finding the salt selection not to be routine.

[00:06:26] Speaker 04:
This court, 10 years ago, nine years ago, excuse me, in Pfizer versus Apotex, considered the nature of salt selection process and found in the connection with amlodipine basilate

[00:06:41] Speaker 04:
in the Pfizer versus Apotex case, that the screening of salts was simply routine.

[00:06:48] Speaker 04:
And that was based on work done in 1986.

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I submit that something that was routine back in 1986 did not become unroutine when conducted in the late 90s.

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It was the same issue.

[00:07:08] Speaker 04:
You know, Pfizer spends a fair bit of time.

[00:07:10] Speaker 04:
Well, let me back up for just a moment.

[00:07:13] Speaker 04:
There's a clear error of fact also in Judge Sleat's opinion with respect to salt selection.

[00:07:19] Speaker 04:
Judge Sleat says that there is, at page 822 in the record, here, unlike in Pfizer, there was nothing in the prior art to suggest to one skilled in the art that malate was one of a limited subset of salts to choose.

[00:07:33] Speaker 04:
The Burge article that formed the basis and was relied upon heavily in the previous Pfizer-Amlodipine case cited a Burge article for the proposition that Bezalate was known in the art to the tune of, I think it was about 0.25% of the available salts, a pharmaceutically acceptable FDA approved salts.

[00:07:56] Speaker 04:
Here, that very same article put into evidence

[00:07:59] Speaker 04:
at a 9-2-1-9 of the record identifies Mallet as assault.

[00:08:07] Speaker 04:
In point 1-3, the district court erred when it discounted and did not cite to that evidence and found instead that there was no evidence submitted.

[00:08:22] Speaker 04:
There absolutely was.

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Moreover, with respect to the 4-2-2 application,

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If you look at the four corners of that document, it fits like a glove with the Merck analysis.

[00:08:40] Speaker 04:
You've got a list of compound structure 2s, aldehydes, and a list of structure 3s, oxydols, that come together into 1,200 combinations approximately.

[00:08:55] Speaker 04:
That dimethyl compound, one of those 1,200

[00:09:02] Speaker 04:
is called a compound within the scope of the invention at A3086, 22 to 23.

[00:09:09] Speaker 04:
And there is statements replete throughout the specification saying that compounds that are within the scope of the invention are expected to be suitable for treating cancer through this antiangiogenesis mechanism or through protein kinase inhibition.

[00:09:31] Speaker 03:
But let me understand your argument.

[00:09:33] Speaker 03:
Is your view that any time you have just an application which has a very broad theory and very kind of general look of you can combine this class of substances with this class of substances to reach an abundance of compounds that will treat cancer?

[00:09:52] Speaker 03:
as a matter of law renders any of the numerous combinations in there obvious?

[00:09:58] Speaker 04:
Your Honor, I would change that a bit.

[00:10:01] Speaker 04:
I don't think it's quite as broad as Your Honor is suggesting, Judge Hughes.

[00:10:05] Speaker 04:
I think that when there are multiple tests for proving obviousness, and when there is this combination set up where the piece of prior art in its four corners says,

[00:10:21] Speaker 04:
You take one of these and you combine it with one of these, and then through routine experimentation, you get to something that is later patented.

[00:10:32] Speaker 04:
And that previous bit of art comes from the same patentee.

[00:10:39] Speaker 04:
Then yes, when it's a discrete, finite number of combinations, then absolutely I agree that as a matter of law,

[00:10:51] Speaker 04:
that those 1200 odd combinations are obviating references over a later patent by the same patentee.

[00:11:00] Speaker 04:
That's exactly the situation we have here.

[00:11:02] Speaker 04:
That's exactly the situation that we had in Merck, and Merck remains good law.

[00:11:05] Speaker 03:
Even though the reference doesn't specifically mention this specific combination or this specific compound.

[00:11:12] Speaker 04:
It does not mention this specific final compound, but

[00:11:15] Speaker 04:
Again, we're one of 1,200 at pages A3086 through 3088, and A3088 through A3090.

[00:11:25] Speaker 03:
But later, in the same disclosure, there are examples... The general problem here, if we take your argument to its logical extreme, I mean, isn't it going to be that if some scientist decides, here's this exciting new theory I have for cancer treatment,

[00:11:42] Speaker 03:
And I've discovered that if you combine these two different classes, they do all this kind of things.

[00:11:46] Speaker 03:
There are hundreds of thousands of combinations.

[00:11:49] Speaker 03:
I don't have the resources to try these out.

[00:11:51] Speaker 03:
I'm going to publish an academic article in this because I want to encourage progress.

[00:11:56] Speaker 03:
And people go out and do the research and patent a new revolutionary drug.

[00:12:01] Speaker 03:
And somebody comes back and said, well, this has already been mentioned 10 years ago in the scientific article.

[00:12:06] Speaker 03:
That's prior art.

[00:12:09] Speaker 03:
inhibit scientific research into these types of drugs?

[00:12:13] Speaker 04:
I don't believe it will, and I don't believe that in that circumstance, so long as the person who does the publication, that scientist, is not the subsequent patentee.

[00:12:24] Speaker 03:
What works the difference there?

[00:12:25] Speaker 03:
I mean, the prior art, it doesn't matter if the prior art comes from the same company or the same scientist or not.

[00:12:32] Speaker 03:
It's still prior art.

[00:12:33] Speaker 04:
Well, it is still prior art, but under the Otsuka lead compound analysis framework,

[00:12:39] Speaker 04:
The patentee himself, if we're limited to just a lead compound analysis for chemical compound patents, then the patentee him or herself has control over what is prior art for obviousness under 103.

[00:12:56] Speaker 03:
So this instead of an application by the same company had instead been a researcher publishing in an academic journal.

[00:13:04] Speaker 03:
Would you then say it's not prior art?

[00:13:07] Speaker 04:
I would say that there's still an argument under Merck, but it's not the same case that we're presented with here.

[00:13:13] Speaker 04:
What's the legal basis for that distinction?

[00:13:15] Speaker 04:
Well, the Merck case itself was based on a Merck prior patent application.

[00:13:20] Speaker 04:
And then Merck later went ahead and patented a combination.

[00:13:24] Speaker 03:
In Merck, did we say anything about why that makes any legal difference for an obvious analysis?

[00:13:30] Speaker 04:
The court didn't parse it that closely, as far as I can recall.

[00:13:34] Speaker 04:
However, the facts, the pertinent facts upon which the Merck court based it were the fact that it was a Merck single reference patent, single reference obviousness challenge.

[00:13:45] Speaker 04:
Here we have a Pfizer patent, two Pfizer patents that have been asserted against Myelin, and we're arguing that a previous Pfizer progeny, it's the same company, the same entity, their patent application should be held against Pfizer.

[00:14:02] Speaker 04:
I think that there is a,

[00:14:04] Speaker 04:
There is a rationale for that.

[00:14:06] Speaker 04:
Now, I'm not suggesting that Merck be read so broadly as to encompass a disclosure of hundreds of thousands or millions of compounds.

[00:14:16] Speaker 04:
That's not the case that we're presented with here.

[00:14:18] Speaker 03:
But where do we draw that line?

[00:14:20] Speaker 03:
I mean, 1,200 is enough to make it obvious, but a million's not?

[00:14:25] Speaker 03:
I mean, that sounds to me like fact finding that's

[00:14:29] Speaker 03:
left to the district court, not a matter of law, which is what you're arguing today.

[00:14:33] Speaker 04:
I understand, Your Honor, but this court has already applied Merck to 1200.

[00:14:39] Speaker 03:
I'm not asking for the court to... Based on those facts, and the district court here found different facts.

[00:14:43] Speaker 04:
If one reads the Merck district court opinion, the Merck district court opinion is very, very similar to the district court opinion that Judge Sleet rendered with respect to this case below.

[00:14:54] Speaker 04:
and the more time one spends with the 813 patent.

[00:14:57] Speaker 04:
But the problem is fact-finding.

[00:14:58] Speaker 03:
I suspect if you had won here and the other side had tried to defend based upon a matter of law, you would have said, well, it's all fact-finding.

[00:15:10] Speaker 03:
We can't review that.

[00:15:11] Speaker 03:
Well, you can review it under a clear error standard.

[00:15:14] Speaker 03:
You're making a legal argument about the application of Merck to obviousness.

[00:15:17] Speaker 03:
I'm not talking about the clear error portions, but I don't understand how

[00:15:22] Speaker 03:
I'm sorry, I've taken you way over your time.

[00:15:24] Speaker 03:
You can just wrap up.

[00:15:25] Speaker 00:
Well, I'm actually out of time and I've reserved the balance.

[00:15:29] Speaker 00:
You don't have any balance, but we'll give you two minutes for rebuttal.

[00:15:32] Speaker 00:
Thank you.

[00:15:36] Speaker 00:
Mr. Selby.

[00:15:40] Speaker 02:
Tom Selby from Williams & Connelly, Minneapolis.

[00:15:45] Speaker 02:
May it please the Court, after a bench trial, then Chief Judge Sleet of the District of Delaware

[00:15:52] Speaker 02:
made factual findings, made credibility determinations, and found that the asserted claims of the 293 and 905 patents were not obvious.

[00:16:02] Speaker 02:
Judge Sleet's 25-page opinion is replete with factual findings, replete with factual findings and conclusions of law in Appellee's favor, almost none of which are challenged by Mylan on appeal, and all of which are supported by ample evidence in the record.

[00:16:18] Speaker 02:
In particular, as we just heard, Mylan doesn't challenge

[00:16:20] Speaker 02:
that under this court's bedrock lead compound analysis, this court should affirm the judgment below.

[00:16:28] Speaker 02:
The 422 compound was found not to be a lead compound.

[00:16:31] Speaker 02:
In fact, it was found to be the epitome of hindsight to assert that this hypothetical compound would be a lead.

[00:16:38] Speaker 02:
And that finding alone is determinative under this court's longstanding lead compound analysis.

[00:16:46] Speaker 03:
But even where do we draw the line here?

[00:16:49] Speaker 03:
If instead of however many combinations, I know you and your friend disagree about how many combinations, but instead of the multitude we have here, the application had said, here's a class of five drugs, combine them with another class of two drugs to get a promising cancer drug.

[00:17:08] Speaker 03:
And they don't go through and list every single combination, but that's a fairly limited universe.

[00:17:14] Speaker 03:
Isn't that kind of per se obvious for a smaller universe?

[00:17:19] Speaker 02:
Judge Hughes, I think the answer to that was posed in your question to Mr. Carson, which is that is a matter for the district court to assess, given all of the evidence and the factual determinations and the witnesses and the credibility determinations in a particular case.

[00:17:36] Speaker 02:
And here we have a finding that it would not have been obvious to try in that circumstance, right?

[00:17:43] Speaker 02:
You could have a circumstance where there was a discrete limited finite

[00:17:47] Speaker 02:
group of compounds where, under KSR, if there were predictable results from that limited discrete set of compounds, that you could arrive at the claimed compound.

[00:18:00] Speaker 02:
That's not the case here.

[00:18:01] Speaker 02:
And there are no factual findings to support that.

[00:18:03] Speaker 02:
In fact, the district court found to the contrary that you would not have arrived at the claimed compounds even starting from the hypothetical dimethyl compound.

[00:18:15] Speaker 02:
And in this case, that is critical.

[00:18:18] Speaker 02:
Even if you take up Mylan's assertion that Merck has some watered down version of the obviousness test, and it does not, and this court has certainly never applied Merck in that way, this court should still affirm the judgment without hesitation.

[00:18:33] Speaker 02:
Because even under Mylan's proposed test, the factual findings that have already been pointed out by the court here are dispositive and lead to affirmance.

[00:18:44] Speaker 02:
First, even starting from the precursors that have been selected by Mylan.

[00:18:48] Speaker 02:
And this act alone would require ignoring all of the prior art teaching away from the particular features of those precursors.

[00:18:55] Speaker 02:
But even starting from those precursors, it does not lead to the claimed compound.

[00:19:01] Speaker 02:
And the district court found, Judge Dyke, as I think you pointed out, that there would be no motivation to modify, starting from the hypothetical dimethyl compound, no more motivation to modify to arrive at the claimed compounds.

[00:19:13] Speaker 02:
The district court found at page 12 of the record that it would not be routine optimization, which is a critical step.

[00:19:19] Speaker 02:
And Judge Hughes, you had asked a question about whether any one of the numerous compounds would be obvious.

[00:19:28] Speaker 02:
And my colleague responded, no, you need routine experimentation to get there.

[00:19:33] Speaker 02:
But in this case, we have a specific factual finding from Judge Sleep at page A12 that there would not have been

[00:19:41] Speaker 02:
that this would not be a matter of routine optimization and it would have required significant guesswork and variation of parameters.

[00:19:49] Speaker 00:
If we had a situation in which there was a prior art patent on a thousand combinations, then wouldn't we be in the genus species situation where in order to say that the species was not obvious, we'd have to show unexpected results?

[00:20:10] Speaker 02:
A large genus is not going to render obvious every compound in that genus without some direction to get to the specific claimed compound here.

[00:20:23] Speaker 00:
I'm not sure that's true.

[00:20:24] Speaker 00:
I'm not sure that in that situation you don't have to show unexpected results in order to make the species separately patentable.

[00:20:35] Speaker 02:
I think it depends on the factual circumstances of the case.

[00:20:38] Speaker 02:
And here, of course, we do have extensive findings of unexpected properties.

[00:20:44] Speaker 02:
The compound here that was discovered, which by the way had features that the prior art taught would be detrimental to activity, was hundreds up to 10,000 times more active than the prior art compounds.

[00:20:57] Speaker 02:
And there's no dispute about what compounds it should be compared to.

[00:21:00] Speaker 02:
And compared to those prior art compounds, it was up to 10,000 times more active.

[00:21:06] Speaker 02:
And so here, we're in a different universe than that situation, because we do have extensive findings of unexpected properties and other objective indicia of non-obviousness.

[00:21:19] Speaker 02:
Now, furthermore, as to the specific changes that would be required to get from this hypothetical compound to the claimed compound, again, the district court made specific factual findings that are supported by the evidence.

[00:21:33] Speaker 02:
The change of these two terminal methyl groups to ethyl groups was a non-obvious change as found at A17 of the record.

[00:21:43] Speaker 02:
And in fact, the 422 application, while it's submitted that the 422 application teaches you by itself to get there, there are no diethyl compounds disclosed in the 422 application.

[00:21:54] Speaker 02:
And what the district court found is that the only motivation proposed by Mylan in this case that you'd be concerned with de-alkylation where you

[00:22:02] Speaker 02:
metabolize that terminal dimethyl compound would apply equally to diethyl and would not motivate you to choose the diethyl and, in fact, would not give you an expectation that choosing the diethyl would solve the problem.

[00:22:16] Speaker 02:
And, in fact, it would teach a way because you would want a cyclic ring, which, in fact, is disclosed in the 422 compound.

[00:22:22] Speaker 02:
And so as the change in the terminal methyl to diethyl

[00:22:27] Speaker 02:
The district court made specific factual findings that that would not have been obvious and would not have been a matter of simply routine experimentation.

[00:22:36] Speaker 02:
Furthermore, the district court found that choosing the extraordinarily rare L-malate salt would not have been obvious to the person of ordinary skill in the art.

[00:22:46] Speaker 02:
And again, that's at age 22 in the record.

[00:22:48] Speaker 02:
Now, one of the critical steps along the way here is what is the motivation to modify?

[00:22:54] Speaker 02:
the district court found, and this is supported by the testimony of Dr. Meyerson, that there would be no reason, or I'm sorry, Dr. Stafford, that there would be no reason to choose assault, any assault, that there was no motivation to select any assault.

[00:23:07] Speaker 02:
That finding is not challenged on appeal.

[00:23:10] Speaker 02:
The point was made that the Burge reference appeared in the Pfizer versus Apotex case and also appears here.

[00:23:18] Speaker 02:
But what was not mentioned is that the

[00:23:22] Speaker 02:
This very rare salt, the malate salt, was not on the list of salts in FDA-approved drugs as of the priority date.

[00:23:30] Speaker 02:
It had fallen out.

[00:23:31] Speaker 02:
It wasn't there.

[00:23:32] Speaker 02:
And at A23 in the record, Judge Sleep found that that was another reason that the salt would not be obvious.

[00:23:38] Speaker 02:
And that's reported at 2399 by Dr. Meyerson.

[00:23:42] Speaker 02:
So the salt itself would have been non-obvious, and there were specific factual findings on that.

[00:23:48] Speaker 02:
Now, even if you

[00:23:51] Speaker 02:
followed Milan's chain and ignored all of these factual findings as to getting to the claimed compound, there would still be no reasonable expectation of success.

[00:24:01] Speaker 02:
Remember here, the hypothetical compound that is the marriage of these two precursors, it had features that were disfavored in the art.

[00:24:12] Speaker 02:
There was no data analyzing it.

[00:24:14] Speaker 02:
It had never been synthesized or described.

[00:24:16] Speaker 02:
As Judge Sleet said, it was the epitome of hindsight

[00:24:20] Speaker 02:
to select it.

[00:24:22] Speaker 02:
And in fact, he found at pages 17 and 18 of the record that there was nothing to suggest that this particular combination would yield promising results.

[00:24:31] Speaker 02:
And so there would be no expectation that the starting point, this hypothetical compound, would have beneficial features, much less all of the alterations that would be required to get you to the claimed compound.

[00:24:44] Speaker 02:
And finally, as I pointed out,

[00:24:45] Speaker 02:
Even if you accept the Merck analysis, the objective indicia here are extraordinarily compelling.

[00:24:52] Speaker 02:
But ultimately, and I'll just spend a moment on this and answer any questions, Merck does not support Mylan's analysis here.

[00:25:00] Speaker 02:
Merck has never been applied to test the obviousness of a chemical compound in a pharmaceutical field and for good reason.

[00:25:07] Speaker 02:
It invites impermissible hindsight.

[00:25:10] Speaker 02:
Merck is about co-administration of two known substances.

[00:25:13] Speaker 02:
You have two diuretics that have known properties and you put them together and the combination has the same properties as the two individually known compounds when you combine them.

[00:25:24] Speaker 02:
That is miles away from the facts here where you have two completely unknown precursors which have no properties that are described in the art whatsoever.

[00:25:35] Speaker 02:
and you put them together, that doesn't provide you with any expectation that the compound is going to have beneficial features.

[00:25:42] Speaker 02:
And in fact, as I said, they had features that were disfavored.

[00:25:48] Speaker 02:
And so Merck simply does not stretch as far as Milam would like.

[00:25:51] Speaker 02:
And that's why this court has rejected the prior attempts to import that case into the chemical obviousness context in both the Otsuka and Lilly cases cited at page 43 in our brief.

[00:26:03] Speaker 02:
Judge Sleet heard all the evidence.

[00:26:05] Speaker 02:
He heard the witnesses.

[00:26:06] Speaker 02:
As you see in his long opinion, he made factual findings and credibility determinations throughout this case.

[00:26:15] Speaker 02:
He supported his opinion with a lengthy set of findings of fact that are supported by the evidence, and we submit that affirmance is the proper result here.

[00:26:28] Speaker 02:
Glad to answer any other questions.

[00:26:31] Speaker 00:
Great.

[00:26:31] Speaker 00:
Thank you, Mr. Sullen.

[00:26:36] Speaker 04:
Your Honor, just very, very briefly, Mr. Selby mentioned there was thousands of times activity of sunitinib as opposed to prior arc compounds.

[00:26:45] Speaker 04:
He said that was a factual finding.

[00:26:46] Speaker 04:
I didn't see that factual finding in the record by Judge Sleet.

[00:26:50] Speaker 04:
In fact, the fact is that predecessor compounds, such as those that below we had argued were suitable for lead compounds, were in clinical trials and had demonstrated efficacy for treating cancer through this antiangiogenesis pathway.

[00:27:06] Speaker 04:
So in terms of unexpected properties, there really were no unexpected properties.

[00:27:10] Speaker 04:
Sunitinib was just like the items that we had identified, prior art compounds we had identified as potential lead compounds for Judge Sleet's evaluation below.

[00:27:21] Speaker 04:
In terms of the issue about the cyclic compound, we believe that Judge Sleet committed clear error there.

[00:27:29] Speaker 04:
Both experts, medicinal chemistry experts below, and this is in our opening brief at page 15,

[00:27:35] Speaker 04:
had said that even if you recognize dealkylation as a potential problem, among the issues or among the items that one would have been motivated to try was the diethylamine.

[00:27:47] Speaker 04:
And then there were a handful of other compounds, including cyclic compounds.

[00:27:51] Speaker 04:
But we're not talking about thousands of options.

[00:27:54] Speaker 04:
Both experts said, yeah, there's five or six.

[00:27:57] Speaker 04:
And we've identified those in our opening brief at page 15.

[00:28:00] Speaker 04:
Finally, there's a suggestion that

[00:28:05] Speaker 04:
There was a later publication on the number of counter ions that were identified as FDA approved.

[00:28:12] Speaker 04:
There was a subsequent to the Burge article, an Anderson article that in which malate had fallen off.

[00:28:19] Speaker 04:
Okay, that doesn't really mean all that much.

[00:28:22] Speaker 04:
And certainly around the time of the priority date, the very patentees here were publicizing the fact they were using malate as a counter ion for another product salt, and that's an A9451.

[00:28:34] Speaker 04:
Unless the panel has any further questions.

[00:28:37] Speaker 00:
Thank you, Mr. Postman.

[00:28:38] Speaker 00:
Thank you.

[00:28:38] Speaker 00:
Thank both counsels.

[00:28:39] Speaker 00:
The case is submitted.