[00:00:08] Speaker 03:
The next case for argument is 161678 Novartis versus Novin Pharmaceuticals.

[00:00:52] Speaker 03:
Ms.

[00:00:52] Speaker 03:
Jacobson, whenever you're ready.

[00:00:54] Speaker 01:
Thank you, Your Honor.

[00:01:01] Speaker 01:
May it please the Court, Charlotte Jacobson on behalf of the Appellant's Novartis.

[00:01:06] Speaker 01:
The question presented to the Board was whether, as of 1998, a person of ordinary skill in the art would have been motivated to combine rivastignine with an antioxidant in the Entz transdermal device.

[00:01:21] Speaker 01:
The board found that a theoretical susceptibility to oxidation would have been enough to motivate a person of ordinary skill to add an antioxidant.

[00:01:32] Speaker 01:
Your Honor, that finding was not supported by substantial evidence.

[00:01:37] Speaker 01:
And with the court's permission, I'll address the substantial evidence issue first, because if the court agrees that the board erred here, it follows that the patents in suit are not obvious.

[00:01:49] Speaker 01:
And Your Honors need not then consider

[00:01:51] Speaker 01:
whether the board also erred in finding that elmalam, sazaki, or river stigmine structure suggested a potential for oxidation.

[00:02:01] Speaker 03:
Can I, before you get to that though, there's a lot of discussion in this case with regard to kind of what I call process issues.

[00:02:09] Speaker 03:
What is your bottom line in terms of what constraints, if any, were applied, should have been applied to the board here?

[00:02:20] Speaker 03:
in light of the district court's determinations in the other case?

[00:02:24] Speaker 01:
Well, it's not Novartis's position that the board was bound by the district court decisions.

[00:02:31] Speaker 01:
But as this court stated in Baxter, where a party has lost in a finally adjudicated court patent validity decision or proceedings, as Noven had here, the board ideally should not have reached a different conclusion.

[00:02:47] Speaker 03:
So where does that take you?

[00:02:50] Speaker 03:
I mean, ideally can be, that phrase can be construed in different ways, I guess.

[00:02:56] Speaker 03:
And it's of course followed in the Baxter decision by a big word, which is called however.

[00:03:02] Speaker 03:
And it goes on to explain.

[00:03:04] Speaker 03:
So where does that, I mean, I know you rely on that phrase.

[00:03:08] Speaker 03:
Where does that lead us?

[00:03:09] Speaker 03:
I mean, I'm trying to really pin down your position about whether it's ideal or not ideal that all forms would reach the same conclusions.

[00:03:19] Speaker 03:
So what?

[00:03:20] Speaker 01:
Well, the board should not have reached an opposite conclusion without having and explaining a sound basis for doing so.

[00:03:28] Speaker 03:
Well, that's true whether or not there's a court decision out there or not.

[00:03:32] Speaker 03:
So I'm trying to glean, whether it's your position, that there's any difference in terms of the way we would analyze what the board did here because of the district court's other proceedings.

[00:03:45] Speaker 01:
Right.

[00:03:46] Speaker 01:
There is a difference here because the board should have

[00:03:49] Speaker 01:
recognized the findings of the district court and explained why it came to a different conclusion on the same evidence that was before the district court.

[00:04:03] Speaker 02:
Did they do that?

[00:04:04] Speaker 02:
On the opinion at page A69, there's a paragraph where the PTAB explains why it was that it came to a different decision and talks about the standard and the burden of proof and other factors.

[00:04:17] Speaker 01:
Well, that's a very conclusory passage.

[00:04:20] Speaker 01:
with respect to the Novin decision.

[00:04:22] Speaker 01:
It simply notes that there's a difference in burden and then says that they found, or the board found, Novin's experts to be more persuasive.

[00:04:31] Speaker 00:
Well, so there's a difference in burden and there's a difference in facts.

[00:04:36] Speaker 00:
That's an explanation.

[00:04:39] Speaker 01:
Right, but let me give Your Honour an example.

[00:04:41] Speaker 01:
So the board found that a theoretical susceptibility to oxidative degradation

[00:04:48] Speaker 01:
would have been enough to motivate the person of ordinary skill in the art to add an antioxidant.

[00:04:54] Speaker 01:
On the same evidence and listening to the same experts, the district court in Noven reached the opposite conclusion and found that theoretical susceptibility would not have been enough to make the patents obvious.

[00:05:07] Speaker 03:
And I'm trying to find out the answer to the question, so what?

[00:05:12] Speaker 03:
I mean, is the board not free to make findings?

[00:05:16] Speaker 03:
I mean, in addition to the fact

[00:05:17] Speaker 03:
to what Judge Stull pointed to, which was the board explicitly drilled down on the district court.

[00:05:24] Speaker 03:
There's another however many pages of analysis, which it may not be specific to what the district court said, but doesn't that also go to, we have a thorough analysis here, do we not, about what the board, how the board construed and analyzed the evidence?

[00:05:39] Speaker 03:
There's no deficiency in and of itself by what the board did here, right?

[00:05:44] Speaker 01:
Well, there are a number of findings that were different between the Board and the District Court in Noven, that the Board did not explain why, for example, the burden made a difference, why the evidence that was presented to the District Court did not prove that susceptibility, theoretical susceptibility was sufficient, but nonetheless, it rose to the level of a preponderance of the evidence.

[00:06:09] Speaker 01:
And because the Board didn't provide any explanation for that difference,

[00:06:13] Speaker 01:
It means that there's no basis for your honors and for this court to assess whether or not the board was correct to reach a different conclusion.

[00:06:24] Speaker 03:
I just want to drill down on that because we have a lot of these cases and these parallel proceedings are coming up more and more often, so that's why I'm probing this.

[00:06:34] Speaker 03:
I'm not just trying to give you a hard time.

[00:06:36] Speaker 03:
But what, I guess, what does that mean?

[00:06:39] Speaker 03:
I mean, we have to evaluate the board's analysis here as we do in every case based on the evidence and its analysis.

[00:06:46] Speaker 03:
What I'm trying to discern is if there's a parallel proceeding in a district court case, what more, not that it might not have been helpful, not that it might not have been nice, but what more are we requiring of the board in this context in order to

[00:07:07] Speaker 03:
dislodge what otherwise may be on their face and based on their analysis seems to us perfectly okay.

[00:07:15] Speaker 03:
Is there just a different standard to be applied here?

[00:07:17] Speaker 03:
And I'm just trying to figure out what that standard is, if it's different.

[00:07:21] Speaker 01:
Well, the Court and Baxter recognize that in order not to elevate the decision of the Patent Office over the decision of a federal court, the board should ideally not come to a different conclusion.

[00:07:35] Speaker 03:
And let's hope it doesn't snow tonight.

[00:07:38] Speaker 03:
But, I mean, that's ideally we would all agree in every case.

[00:07:43] Speaker 03:
I mean, that's nice, but where does that get us?

[00:07:46] Speaker 03:
What does that mean that we have to apply that?

[00:07:48] Speaker 03:
Just because it's ideal doesn't mean it has any of it, doesn't give us any information about what effect that might have on what standards we are to apply here different from what we would apply in an ordinary case when there's just a board proceeding we're reviewing.

[00:08:04] Speaker 01:
Right.

[00:08:04] Speaker 01:
And the additional thing that the board should be required to do is provide an explanation as to why it reached an opposite conclusion that is more than... But it did.

[00:08:14] Speaker 02:
Did they say, they said, for example, it's a very technical case, right?

[00:08:18] Speaker 02:
It is.

[00:08:19] Speaker 02:
And what they said was, we have accorded persuasive weight to the testimony of petitioners to Clarence, which is different than what the district court did.

[00:08:29] Speaker 02:
I mean, that's one very strong reason, I would think, for why they came to the conclusion that they did.

[00:08:35] Speaker 01:
Great.

[00:08:35] Speaker 01:
But the board could say that in every single case, simply say the burden is different.

[00:08:40] Speaker 01:
We find the experts persuasive.

[00:08:41] Speaker 02:
But they did more than that.

[00:08:43] Speaker 02:
They did go on, as Judge Prost pointed out, they go on page 880, for example, to talk about, you know, and many other pages, to talk about why it is that they concluded the way they did on this, you know, that Sasaki

[00:08:58] Speaker 02:
would, for example, teach one of ordinary scale in the art that there was an expectation that the ENZ's transdermal patch would be unstable.

[00:09:10] Speaker 01:
But that finding with respect to Suzuki was the opposite from what the district court found.

[00:09:17] Speaker 01:
And one thing that the district court pointed to was that there were authoritative textbooks such as modern pharmaceutics and ANSAL that didn't identify

[00:09:26] Speaker 01:
means as a functional group that had the potential to oxidize.

[00:09:33] Speaker 01:
And what the board never did was explain why it credited the unexamined Japanese patent application over those authoritative textbooks which had been material to the decision of the district court with respect to Suzuki.

[00:09:49] Speaker 01:
And so because it didn't provide any explanation or any basis for that difference,

[00:09:55] Speaker 01:
There's no analysis that would allow your honors to assess whether or not the difference in the burden justified the difference in the decision.

[00:10:05] Speaker 03:
So that's my question.

[00:10:07] Speaker 03:
Even if we were to agree with you, what are we compelled to do?

[00:10:12] Speaker 03:
If we were to fairly read the sport opinion in and of itself and say, this is more than sufficient.

[00:10:18] Speaker 03:
There's substantial evidence here.

[00:10:19] Speaker 03:
They did all the analysis.

[00:10:21] Speaker 03:
They went through everything in the record.

[00:10:23] Speaker 03:
and we're satisfied that reading the four corners of their opinion, it's affirmable.

[00:10:28] Speaker 03:
Are you saying that because they had a higher burden here to differentiate every finding, to explain every different finding they had from the district court and talk about that and explain how the burden explains the difference here and given their failure to do that,

[00:10:52] Speaker 03:
Is that a basis for our reversing their opinion?

[00:10:56] Speaker 03:
I mean, I'm just trying to figure out what do we do with that?

[00:10:59] Speaker 03:
Even if we agree with everything you're saying, what do we do with that?

[00:11:03] Speaker 01:
Well, Your Honours, if you agree that all of the findings are supported by substantial evidence and that then it follows that the court was, I'm sorry, the board was justified in departing from the district court, but the board hasn't provided... Is that the standard though?

[00:11:18] Speaker 03:
Is the standard whether there's substantial evidence to support what the board did?

[00:11:22] Speaker 03:
Or is the standard we are to apply on review, was the board here justified?

[00:11:28] Speaker 03:
And I don't know what standard that justification takes on.

[00:11:32] Speaker 03:
But was the board justified in its disagreements with the district court?

[00:11:37] Speaker 03:
This is a district court opinion, by the way, which we didn't review this case, right?

[00:11:42] Speaker 03:
Not on this record.

[00:11:42] Speaker 03:
There's no federal circuit opinion.

[00:11:44] Speaker 01:
No, there's no.

[00:11:45] Speaker 01:
But it's a final district court decision because it hasn't been appealed.

[00:11:51] Speaker 03:
And so tell us how, what just level of justification is, if a level of justification is required, what standards we are to apply to inform that.

[00:12:02] Speaker 01:
Your honor, I think that that justification would need to be supported by substantial evidence.

[00:12:08] Speaker 01:
It would be a finding of fact that there is a difference between the district court or the evidence before the board and the district court that would have justified the departure from this court's guidance.

[00:12:20] Speaker 01:
in Baxter and then at the Noven District Court decision.

[00:12:27] Speaker 01:
So I see I'm out of time.

[00:12:28] Speaker 03:
You're in your rebound.

[00:12:29] Speaker 03:
You want to sit down?

[00:12:29] Speaker 03:
We'll hear from the other side.

[00:12:31] Speaker 03:
Thank you.

[00:12:38] Speaker 03:
Ms.

[00:12:38] Speaker 03:
Lynch, it appears you're the last person standing on this side of the table.

[00:12:42] Speaker 04:
May it please the court, this case isn't about the relative primacy of the board and the courts.

[00:12:49] Speaker 04:
It's simply one of those cases where the board's application of a lower standard of proof, preponderance of the evidence, resulted in a different decision than that reached by the district court.

[00:13:00] Speaker 00:
And different evidence, too.

[00:13:01] Speaker 04:
And different evidence.

[00:13:03] Speaker 04:
That's what I want to go to.

[00:13:05] Speaker 04:
Novartis spends a lot of time on the Baxter case.

[00:13:09] Speaker 04:
And this one sentence that when there's the same presentations and arguments, ideally the board should not come to a different conclusion than a district court.

[00:13:18] Speaker 04:
But it was Novartis's burden to show that it was the same presentations and arguments.

[00:13:23] Speaker 04:
And the board found that it wasn't the same presentations and arguments.

[00:13:25] Speaker 02:
With respect to Watson, right?

[00:13:27] Speaker 02:
Only with respect to the Watson decision.

[00:13:30] Speaker 02:
I think with respect to the Novin decision, the PTAB actually recognized that it was the same evidence.

[00:13:36] Speaker 02:
Am I right about that?

[00:13:37] Speaker 04:
It was the same art that the board relied on, but not the same evidence.

[00:13:41] Speaker 04:
Because new declarations were put in.

[00:13:43] Speaker 04:
By the same experts.

[00:13:45] Speaker 00:
Same experts.

[00:13:47] Speaker 00:
And in a sort of backwards way, the reclibrary concedes they're different by saying they're substantively the same.

[00:13:59] Speaker 04:
Right.

[00:13:59] Speaker 04:
But the board actually said that there was different presentations and arguments.

[00:14:05] Speaker 04:
And then getting to Chief Judge Prost's questions about

[00:14:08] Speaker 04:
what the courts should do here.

[00:14:11] Speaker 04:
And is there something you need to do beyond looking to whether the board's fact findings were supported by substantial evidence?

[00:14:18] Speaker 03:
Well, it's helpful that the board had something, as Judge Stowe pointed out, that they did recognize and at least discuss at some level the district court's conclusions, right?

[00:14:28] Speaker 04:
Correct.

[00:14:28] Speaker 03:
So the question maybe begs the question of how much they needed to do, if anything, to satisfy us when there's a parallel proceeding involving

[00:14:37] Speaker 03:
let's assume for the sake of argument that the records are substantially the same.

[00:14:44] Speaker 04:
Correct.

[00:14:45] Speaker 04:
And the board did here look to the district court decisions.

[00:14:50] Speaker 04:
But we have a charter from Congress to do our own patentability determinations and to do an independent patentability analysis.

[00:14:57] Speaker 04:
That is what the board did, applied the appropriate standard of proof.

[00:15:02] Speaker 04:
And I want to read something in Baxter which says specifically

[00:15:06] Speaker 04:
that the board doesn't have to do kind of this side-by-side comparison that Novartis is asking for to say, for every finding the board has, please compare it to what the district court said and tell us why you came to a different one.

[00:15:19] Speaker 04:
If you look at page 1365 of Inray Baxter in the paragraph that begins, in contrast, the last sentence says, thus, because the two proceedings necessarily apply

[00:15:35] Speaker 04:
different burdens of proof and relied on different records, the PTO did not err in failing to provide the detailed explanation now sought by Baxter as to why the PTO came to a different determination than the court system.

[00:15:50] Speaker 03:
But it's a lot easier, a lot more apparent when the records are significantly different, when there's different prior art cited, where there are different experts that say different things.

[00:16:01] Speaker 03:
That's a lot easier.

[00:16:03] Speaker 04:
It is easier, Your Honor.

[00:16:04] Speaker 04:
But here, the board went through all of the art, explained what it thought the art taught a person of ordinary skill in the art, and came to its conclusion.

[00:16:16] Speaker 04:
I don't think there's any requirement for the board to go line by line and say, well, the district court said this, we say this.

[00:16:24] Speaker 03:
Well, there's one thing that's bothering me a bit, and your friend didn't really rely heavily on it here, although I think it's in the briefs, which is this aspect of credibility determinations.

[00:16:34] Speaker 03:
Because what if hypothetically you have a district court proceeding and the district court hears the witnesses?

[00:16:41] Speaker 03:
And I think expert testimony is a little different because sometimes credibility mixes up the extent to which they had a significant scientific basis for coming to their conclusions.

[00:16:54] Speaker 03:
But what if it was what we typically think of as credibility?

[00:16:57] Speaker 03:
Like this guy started to sweat across examination and it was just apparent to me sitting there listening to him

[00:17:04] Speaker 03:
that he was lying based on his demeanor and the way he was twisting in his seat.

[00:17:09] Speaker 03:
So it's really a traditional kind of credibility determination.

[00:17:13] Speaker 03:
What if the district court had significantly relied on her conclusions in that regard in reaching the result here?

[00:17:22] Speaker 03:
Would the board have to sort of take note of that in any way, shape or form or not?

[00:17:27] Speaker 04:
I don't think the board would, Your Honor, because we have our own proceedings, and Congress has set them up, and they are pretty much on the paper.

[00:17:36] Speaker 04:
There are instances where the board can hear oral witnesses, but pretty much they're on the paper.

[00:17:43] Speaker 00:
What happens when the prior litigant comes in and says, well, wait a minute, it bite by affidavit?

[00:17:54] Speaker 00:
attached is a copy of the district court opinion in which they find this person to be an abject liar or refer them for perjury prosecution.

[00:18:03] Speaker 00:
Let's make it really good.

[00:18:05] Speaker 00:
And so surely in some fashion that's brought to the board.

[00:18:12] Speaker 04:
Correct.

[00:18:13] Speaker 04:
And the board can take note of that, but we're not bound by district court credibility determinations.

[00:18:19] Speaker 04:
If we were,

[00:18:20] Speaker 04:
Then in re-exams, we could never find patents unpatentable because re-exams are on the paper, right, even when there had been a district court decision.

[00:18:29] Speaker 04:
So, I mean, we, under our charter from Congress, this is what we do.

[00:18:34] Speaker 02:
You'd have to address it though, right?

[00:18:35] Speaker 02:
Like maybe say something like, for example, the district court found this expert's testimony not to be credible because whatever reason, but we, with our independent assessment, given our technical backgrounds,

[00:18:49] Speaker 02:
have read this reference and read it differently, at least some sort of explanation, right?

[00:18:56] Speaker 04:
I don't know that they would be absolutely required to do that, but I think that would be the better course.

[00:19:01] Speaker 04:
And in this case, they did look at, there's no question that they looked at the Novin District Court decision and the Watson Federal Circuit and District Court decision.

[00:19:11] Speaker 03:
Maybe it was one of the other briefs on the other side, but I thought someone made the additional argument in response to the question I was posing.

[00:19:20] Speaker 03:
that there is the ability under your proceedings to bring in live testimony.

[00:19:25] Speaker 03:
Am I wrong about that?

[00:19:26] Speaker 03:
No.

[00:19:27] Speaker 04:
Is there ability?

[00:19:28] Speaker 04:
There is an ability, and Novartis did not ask for it.

[00:19:32] Speaker 03:
And so one of the answers might be that if this guy, if you saw a person, you'd know in five seconds that this guy was a liar.

[00:19:41] Speaker 03:
If that were the view of the other case in this hypothetical we're talking about, they

[00:19:47] Speaker 03:
they have the ability to at least ask.

[00:19:49] Speaker 03:
Not that we may have said no, but they have the ability.

[00:19:51] Speaker 04:
Correct.

[00:19:52] Speaker 04:
And that would make sense, Your Honor, that you would maybe put that in a motion and say, in this case, we do think testimony would be useful because of what happened in the district court.

[00:20:01] Speaker 02:
Are you familiar with the power integrations case?

[00:20:04] Speaker 02:
That's the one.

[00:20:04] Speaker 02:
I don't think it's been cited by the parties here, but that's one where this court, I think there was a district court decision that interpreted claims one way.

[00:20:13] Speaker 02:
And then when it was before the board, the board had a different interpretation.

[00:20:17] Speaker 02:
And this court remanded for the board just to make sure that it was clear that the board considered the district court's interpretation and address it in an opinion.

[00:20:28] Speaker 04:
Right.

[00:20:28] Speaker 04:
And we feel like in this case, the board certainly did that.

[00:20:31] Speaker 04:
It looked at both the Noven District Court case and the Watson case.

[00:20:35] Speaker 04:
So we believe the only question before this court is whether the board's fact findings are supported by substantial evidence in its conclusion.

[00:20:43] Speaker 04:
or correct as a matter of law.

[00:20:48] Speaker 02:
Thank you.

[00:20:48] Speaker 02:
Wait, I have one more question.

[00:20:49] Speaker 02:
I'm sorry, I forgot.

[00:20:50] Speaker 02:
I just was wondering about, I saw that there was some emphasis in the briefs on the board's definition of one of ordinary scale in the AR, and that that was not contested by Novartis.

[00:21:04] Speaker 02:
I was wondering if you knew, was that the same definition that was relied on in the district court?

[00:21:08] Speaker 04:
I apologize, Your Honor, I don't know.

[00:21:10] Speaker 04:
That's not something we briefed.

[00:21:12] Speaker 01:
Thank you.

[00:21:25] Speaker 01:
Your Honor, I just want to focus on two points.

[00:21:28] Speaker 01:
The first is that the prior art of record was the same between the Noven Court and the proceedings before the board, as this court pointed out.

[00:21:38] Speaker 01:
And the part of the Baxter decision that the PTO pointed to makes clear that the record was different between the PTO proceedings and the court proceedings.

[00:21:51] Speaker 01:
And that was why the court in Baxter did not require a detailed explanation of the different outcomes in those two cases.

[00:22:00] Speaker 01:
The court in Baxter then went on.

[00:22:03] Speaker 00:
Wait, wait, wait, but you're mixing prior art and record.

[00:22:07] Speaker 00:
I know you're not doing that by accident.

[00:22:11] Speaker 01:
Well, there's no dispute that the prior art was the same.

[00:22:16] Speaker 00:
But the record was different, wasn't it?

[00:22:18] Speaker 01:
Not substantively.

[00:22:20] Speaker 01:
There is no evidence that has been pointed to.

[00:22:23] Speaker 00:
That's what I referred to in your footnote 11 as backing into it, conceding that it was different.

[00:22:29] Speaker 01:
Well, it's a form of a substance, Your Honor.

[00:22:32] Speaker 01:
The form of the record was different, but the testimony wasn't.

[00:22:36] Speaker 01:
Neither the PTO nor the board nor NOVEN has pointed to any difference in testimony from the experts between what they said in the court and what they said in their declarations.

[00:22:48] Speaker 01:
Now, with respect to the art of record, there were a couple of different references that were before the board, but none of them were relied on by the board in reaching its decision.

[00:22:59] Speaker 01:
And in fact, none of them were even properly before the board because they were only cited in declarations of the experts

[00:23:06] Speaker 01:
And therefore, under the procedure with the board, they're not... So the... Wait, wait, wait, wait, wait, wait.

[00:23:12] Speaker 00:
The declarations of Dr. Candesius, Dr. Schoenbach, and Dr. Kleibnopf were before the court?

[00:23:22] Speaker 01:
No, the declarations were only before the board.

[00:23:25] Speaker 01:
But they were the exact same experts that testified before the court.

[00:23:35] Speaker 03:
And then Noven pointed to... Do we know if the substance of the testimony versus the declarations were different?

[00:23:42] Speaker 03:
It was different.

[00:23:43] Speaker 00:
Because I'm turning to the record to see where they said it was different.

[00:23:49] Speaker 00:
The board said it was different.

[00:23:51] Speaker 01:
Only between the Noven case, Your Honor.

[00:23:54] Speaker 01:
The board did not identify any differences between the testimony at the district court and before the board from these same three experts in the Noven proceedings.

[00:24:04] Speaker 01:
in the two jurisdictions and Noven in their brief did not identify any difference in the testimony and the PTO has not identified any difference in the testimony offered by these experts.

[00:24:17] Speaker 03:
Well I think the PTO may have said something that suggested that it may have been your burden and not theirs if there's a difference in the record to call that out.

[00:24:25] Speaker 01:
And we submit that there was not a difference in substance between the testimony that was given at the court and in the

[00:24:34] Speaker 01:
in the written declarations.

[00:24:38] Speaker 01:
And the second point is, and I wanted to emphasize, is the district court saw and heard these experts testify.

[00:24:47] Speaker 01:
And having heard these experts testify, the district court made an express finding that Dr. Klebenoff-Novatis's expert was more credible than both of Novan's experts, Dr. Kedonius and Dr. Schoenike.

[00:25:04] Speaker 01:
and the PTO.

[00:25:05] Speaker 01:
Do we know why?

[00:25:06] Speaker 03:
Did the district court provide us a why?

[00:25:09] Speaker 03:
It was not based on demeanor, was it?

[00:25:11] Speaker 03:
It was based on the scientific basis for what he was saying, or what?

[00:25:16] Speaker 03:
I don't recall exactly what the district court said.

[00:25:19] Speaker 01:
The district court did not expressly say it was because of the demeanor of the witness, but certainly when assessing credibility, demeanor, and the substance of what the expert is testifying about is what the court will consider

[00:25:33] Speaker 01:
when it reaches a finding as to credibility.

[00:25:36] Speaker 01:
And in this case, the district court found Dr. Klebenoff more persuasive, more credible.

[00:25:44] Speaker 01:
The board, on the other hand, without providing reasons, found that Dr. Klebenoff's testimony was not persuasive.

[00:25:52] Speaker 01:
And then it proceeded on the Elmalem reference to make its own conclusion about what that reference would have taught a person of ordinary skill in the art

[00:26:02] Speaker 01:
that was not supported by either side's expert.

[00:26:05] Speaker 01:
It was its own independent conclusion as to what that reference meant.

[00:26:11] Speaker 02:
Earlier, you referred to a theoretical possibility.

[00:26:15] Speaker 02:
I don't see that language in the board's decision.

[00:26:17] Speaker 02:
Where is that in the board's decision?

[00:26:20] Speaker 01:
Well, the board makes clear that it talks about susceptibility to oxidation.

[00:26:26] Speaker 01:
But the board recognizes that that

[00:26:29] Speaker 01:
Susceptibility does not mean that the drug is going to undergo oxidative degradation under pharmaceutically relevant conditions.

[00:26:37] Speaker 01:
And so with respect... When does it say that?

[00:26:41] Speaker 02:
I just didn't see.

[00:26:42] Speaker 02:
I think that's... Had the board actually articulated a standard like, we think it's susceptible, or that's possible.

[00:26:50] Speaker 02:
And then maybe that would be a pretty strong argument.

[00:26:54] Speaker 02:
But their argument seems to be that one of ordinary scale in the art would appreciate

[00:26:59] Speaker 02:
from Sasaki that there is a problem, there is an oxidation problem in the ENDS product.

[00:27:09] Speaker 01:
So at A86, the board acknowledged that whether a compound degrades needs to be shown experimentally.

[00:27:17] Speaker 01:
And that was undisputed by Novin's experts.

[00:27:20] Speaker 01:
In fact, they admitted that that was the case.

[00:27:23] Speaker 01:
At A87, Your Honor, the board goes on and says,

[00:27:27] Speaker 01:
It is the susceptibility, i.e.

[00:27:30] Speaker 01:
the predicted potential for oxidative degradation that provides the motivation to address the problem.

[00:27:37] Speaker 01:
And then if you look at A88, the board's ultimate conclusion with respect to ENCE and Suzuki is that a poster would have predicted that the transdermal formulation disclosed by ENCE was susceptible to oxidative degradation.

[00:27:55] Speaker 03:
So what's wrong with that?

[00:27:57] Speaker 03:
I think here they were pushing back, and the briefs get into the stance too, pushing back between whether it was able to predict absolutely or whether it was sufficient.

[00:28:10] Speaker 03:
And here the board makes a finding which is supported on 888, which is discussed and supported by the previous pages.

[00:28:18] Speaker 03:
So what's the problem with that?

[00:28:20] Speaker 01:
The problem is that those findings were not supported by substantial evidence.

[00:28:24] Speaker 01:
There was no evidence of record that a predicted potential or a theoretical susceptibility for oxidation would have been sufficient to motivate a person of ordinary skill in the art to add an antioxidant.

[00:28:40] Speaker 01:
Instead, the record evidence shows that a person of ordinary skill in the art would only have been motivated to solve a known degradational stability problem.

[00:28:52] Speaker 01:
As the age-old adage goes, if it ain't broke, don't fix it.

[00:28:55] Speaker 03:
But I think Judge Stowe, maybe I misunderstood.

[00:28:58] Speaker 03:
I thought she was asking about what you just said again, which is a theoretical possibility.

[00:29:03] Speaker 03:
And is that language used by the board?

[00:29:08] Speaker 01:
It's not.

[00:29:08] Speaker 01:
It's the way that we try to explain the difference between susceptibility and actually having a degradation problem.

[00:29:16] Speaker 01:
because it was undisputed that even a compound that is susceptible to oxidative degradation may not degrade at all under pharmaceutically relevant conditions.

[00:29:27] Speaker 01:
And Noven's expert, Dr. Schoenig, admitted that even in a compound that has a bond that could be oxidized or that is weaker than others, that doesn't mean that the drug will undergo oxidative degradation.

[00:29:41] Speaker 01:
It doesn't tell you what conditions will be required to cause that drug

[00:29:46] Speaker 01:
to degrade.

[00:29:48] Speaker 01:
And in fact, take the example of dextromethorphan.

[00:29:50] Speaker 03:
I'll give you one more sentence.

[00:29:51] Speaker 03:
I know you're responding to questions, so I appreciate you went over time, but one sentence.

[00:29:55] Speaker 01:
OK, sorry.

[00:29:56] Speaker 01:
The example of dextromethorphan is very informative.

[00:29:59] Speaker 01:
Under the theory... That was a sentence.

[00:30:04] Speaker 01:
Sorry.

[00:30:04] Speaker 01:
That was a drug that should have been susceptible to oxidation, and yet it was reported to be very stable under pharmaceutically relevant conditions.

[00:30:14] Speaker 01:
and was not formulated with an antioxidant.

[00:30:17] Speaker 01:
And that well illustrates the difference between a theoretical susceptibility and an actual degradation problem.

[00:30:24] Speaker 03:
Thank you.

[00:30:25] Speaker 03:
We thank both sides.

[00:30:26] Speaker 03:
The case is submitted.