[00:00:00] Speaker 03:
Our next case for argument is 24-1181, Shilpa Pharma versus Novartis Pharmaceuticals.

[00:00:07] Speaker 03:
Before I proceed, I forgot to welcome Judge Bum, the Chief Judge of the District of New Jersey.

[00:00:15] Speaker 03:
We're very appreciative of her coming to sit with our court today.

[00:00:19] Speaker 03:
So thank you.

[00:00:20] Speaker 02:
I'm happy to be here.

[00:00:20] Speaker 02:
Thank you, Judge.

[00:00:22] Speaker 03:
Mr. Boland, please proceed.

[00:00:25] Speaker 00:
Good morning.

[00:00:26] Speaker 00:
May I please the court?

[00:00:29] Speaker 00:
Is this 11 minutes here?

[00:00:33] Speaker 00:
Thanks.

[00:00:36] Speaker 00:
There's one issue that's dispositive of all the claims in this appeal, and that is the enablement of MUTs as a prior art reference.

[00:00:45] Speaker 00:
And, of course, as a prior art reference,

[00:00:50] Speaker 00:
there must be an enabling disclosure of the subject matter that we relied on for the unpatentability.

[00:00:56] Speaker 00:
And here, that's primarily the form one, polymorph, in MUTs.

[00:01:01] Speaker 00:
But MUTs doesn't have that disclosure.

[00:01:04] Speaker 00:
There's no teaching of a chemical synthesis of how to make form one.

[00:01:08] Speaker 03:
And you don't like the, well, no, I don't think Mutt's discloses it either, but they look to Fujita.

[00:01:16] Speaker 03:
Fujita?

[00:01:17] Speaker 03:
Fujita.

[00:01:17] Speaker 03:
Fujita.

[00:01:18] Speaker 03:
And Fujita, because they say they incorporate it by reference.

[00:01:22] Speaker 03:
And tell me what your problems are with incorporation by reference first.

[00:01:26] Speaker 03:
OK, so.

[00:01:26] Speaker 03:
First let me ask, do you think Fujita discloses how to make it?

[00:01:30] Speaker 00:
Well, Fujita discloses, example 29, primarily.

[00:01:34] Speaker 00:
That was the crux of the issue below.

[00:01:37] Speaker 00:
But Fujita discloses, in example 29, how to make the fangolimide hydrochloride salt.

[00:01:45] Speaker 00:
Then, at the tail end of that example, it says, and then it was recrystallized in ethanol to give so many grams of the subject compound.

[00:01:56] Speaker 00:
Okay?

[00:01:56] Speaker 00:
Fujita doesn't say that compound was form one.

[00:02:00] Speaker 00:
And in contrast, Mukt says it's form one and it's form two and three, formed by eating, are novel.

[00:02:09] Speaker 00:
So how do you reconcile those?

[00:02:12] Speaker 03:
I think I asked a really specific question.

[00:02:16] Speaker 03:
Is Fujita enabling

[00:02:18] Speaker 00:
No, Your Honor, it is not.

[00:02:21] Speaker 00:
There's no case that's ever found that a prior arc's disclosure of a compound has enabled the production of a specific polymorph.

[00:02:31] Speaker 00:
And further, there's no case that's ever held that even if that compound in the prior art is crystalline, that that's an enabling disclosure of the production of a specific polymorph.

[00:02:45] Speaker 00:
And yet, that's exactly what the board did in concluding here, that both Fujita and, to some extent, this Kurichi reference enabled the production of Form I.

[00:02:56] Speaker 01:
Can I just make sure I understand your argument?

[00:02:58] Speaker 01:
You're really emphasizing here the unique structure of the polymorph, right?

[00:03:05] Speaker 01:
That it's something about the polymorph, the fact that this is polymorph technology itself, makes it so your enablement argument is stronger.

[00:03:15] Speaker 01:
Do my understanding that?

[00:03:16] Speaker 00:
Yes, Your Honor.

[00:03:17] Speaker 00:
And just to be clear, polymorph formation is very highly unpredictable chemistry.

[00:03:24] Speaker 00:
And as this court recognized in the Grunenthal case we cited at 919 F 1333, a crystalline compound is not necessarily polymorphic.

[00:03:36] Speaker 00:
Further, the court recognized that only if a crystalline form can exist in multiple solid-state 3D arrangements is it polymorphic.

[00:03:46] Speaker 00:
And those are at pages 13 – 1341 and 1336, respectively.

[00:03:52] Speaker 00:
So even if Example 29 of Fujita disclosed a crystalline compound – and that's not even clear.

[00:03:58] Speaker 00:
It says the subject compound at the very end.

[00:04:01] Speaker 00:
There's no way to know whether it existed in a polymorphic form.

[00:04:05] Speaker 00:
And Mutz says it discovered polymorphism of phenolamide hydrochloride.

[00:04:12] Speaker 00:
So how could Fujita

[00:04:14] Speaker 00:
teach and enable the production of Form 1 when Mutts later says Mutts discovered polymorphism.

[00:04:22] Speaker 00:
Mutts just invented novel forms.

[00:04:24] Speaker 01:
What do you think Fuchida meant by the subject?

[00:04:31] Speaker 01:
What do you think it meant other than Form 1?

[00:04:33] Speaker 00:
It was a compound.

[00:04:34] Speaker 00:
It was an organic compound.

[00:04:36] Speaker 00:
it's not clear if it was even a crystalline compound.

[00:04:40] Speaker 00:
It was an organic – you wouldn't know unless you took an X-ray diffraction on that particular compound because that will tell you if it's crystalline, you'd get peaks.

[00:04:51] Speaker 00:
If it's amorphous, you'd get broad humps.

[00:04:55] Speaker 00:
Okay?

[00:04:55] Speaker 00:
So there was no data to tell you that was Form I. There was no data to tell you that was any type of polymorph at all.

[00:05:03] Speaker 02:
But enablement allows for that type of experimentation, doesn't it?

[00:05:06] Speaker 00:
Yes, Your Honor, but in this particular context, there was three broad categories of evidence related to polymorph formation that the board simply did not consider in its analysis.

[00:05:18] Speaker 00:
First was there was undisputed evidence that even slight alterations in the synthesis techniques will give rise to different polymorphs.

[00:05:33] Speaker 00:
Okay?

[00:05:34] Speaker 00:
And both parties' experts agreed with that.

[00:05:38] Speaker 00:
Second, both parties' experts agreed that changes in recrystallization conditions could have a profound effect on the resulting crystal form of a compound.

[00:05:49] Speaker 00:
Okay?

[00:05:50] Speaker 00:
All four experts in the case agreed with that proposition.

[00:05:54] Speaker 00:
And so when Fujita says it was recrystallized for methanol to give so many grams of the subject compound,

[00:06:03] Speaker 00:
That doesn't tell you how they did the recrystallization.

[00:06:06] Speaker 00:
It involves how long did it take for each step?

[00:06:10] Speaker 00:
What were the temperatures?

[00:06:11] Speaker 00:
Was there agitation?

[00:06:14] Speaker 00:
How long did it take to dissolve?

[00:06:15] Speaker 00:
Did they do anything special to dissolve it?

[00:06:18] Speaker 00:
How did they bring it out of solution?

[00:06:20] Speaker 00:
How did they cool it?

[00:06:21] Speaker 00:
Was it under vacuum or not?

[00:06:23] Speaker 00:
So in contrast to what Fujita says in example 29, you can look by comparison in the 816 patent at issue here.

[00:06:32] Speaker 00:
In column eight, lines 30 to 47, you have example two and process A, which gives form beta, okay?

[00:06:41] Speaker 00:
And there, what you have is a detailed description of a recrystallization reaction with all the times, temperatures, agitation conditions, cooling, and bringing it out of solution and drying it under a vacuum for 12 hours.

[00:06:56] Speaker 00:
That's what's missing in Fujita.

[00:06:58] Speaker 00:
That's what's missing in Keiuchi.

[00:07:02] Speaker 03:
How does the board err to the extent that it rejected your argument about the differences between the melting points in Mutz and example 29, and especially in light of their reliance on Dr. McClurg?

[00:07:16] Speaker 03:
How is that erroneous?

[00:07:17] Speaker 00:
Sure.

[00:07:19] Speaker 00:
Melting points is just one of several categories that wasn't properly considered in our view.

[00:07:23] Speaker 00:
But as to melting points particularly,

[00:07:26] Speaker 00:
They relied on Dr. McClurg.

[00:07:27] Speaker 00:
So Fujita got a melting point of 118 to 120.

[00:07:32] Speaker 00:
The board found that, in months, the melting point was 107.

[00:07:36] Speaker 00:
So that's an 11 to 13-degree difference.

[00:07:39] Speaker 00:
Dr. McClurg said, without citing anything – oh, that's just within the range of experimental errors, variations, whatever, okay – there was speculation.

[00:07:50] Speaker 00:
What the board didn't consider was SHUPA's evidence.

[00:07:53] Speaker 00:
Our expert, Dr. Mello, testified on that exact point and gave substantial testimony that was never mentioned.

[00:08:02] Speaker 00:
He pointed out that Dr. McClure didn't cite one single piece of literature to support it.

[00:08:08] Speaker 03:
Unfortunately, that's a fact-finding, and I don't re-weigh evidence.

[00:08:12] Speaker 03:
I just have to say, was that clearly erroneous fact-finding?

[00:08:16] Speaker 03:
So you're telling me all the reasons why the board should have made a different decision, but I don't get to do that.

[00:08:22] Speaker 00:
understood, Your Honor.

[00:08:23] Speaker 00:
But where the board's fact findings don't take into account swaths of evidence or grapple with our evidence and say, right, sorry.

[00:08:34] Speaker 02:
It sounds like what you're saying is because the board didn't address it, they didn't consider it.

[00:08:38] Speaker 02:
And I don't know that on what grounds can you even assume, to Judge Moore's point, that we even have to look that far.

[00:08:46] Speaker 02:
But how do you get there?

[00:08:50] Speaker 00:
There's, we saw a case of aqua products and provisor.

[00:08:53] Speaker 02:
No, my question is, how do you get that the board didn't consider it simply because they didn't address it?

[00:08:57] Speaker 02:
Maybe they considered it, rejected it, they just didn't write about it.

[00:09:00] Speaker 00:
Yeah, so of course, the board doesn't have to write about every single piece of evidence, every single item of testimony.

[00:09:08] Speaker 00:
But they have to address our case.

[00:09:11] Speaker 00:
And our position was not properly addressed.

[00:09:14] Speaker 00:
And therefore, those findings can't be... Did you argue an APA violation?

[00:09:18] Speaker 00:
Yes, we did, Your Honor.

[00:09:19] Speaker 00:
On multiple... On multiple aspects... Yes, Your Honor, on multiple aspects of not considering our evidence.

[00:09:26] Speaker 00:
And we cited the cases I just referenced.

[00:09:28] Speaker 00:
So we believe melting point is one of many points.

[00:09:32] Speaker 00:
But another category that wasn't considered is there was substantial undisputed and unchallenged evidence explaining that if you took Fujita example 29, undue experimentation would be required to adapt that procedure into an enabling synthesis of form one.

[00:09:56] Speaker 00:
Our expert gave testimony on that.

[00:09:58] Speaker 00:
It was unrebutted.

[00:09:59] Speaker 00:
He was not even deposed.

[00:10:01] Speaker 00:
And that was just simply, again, ignored by the Patent Office.

[00:10:05] Speaker 02:
McClure couldn't address that?

[00:10:08] Speaker 00:
I don't believe so, Your Honor.

[00:10:09] Speaker 02:
Because we have found McClure credible.

[00:10:11] Speaker 02:
We certainly don't want credibility.

[00:10:15] Speaker 00:
I don't know that Dr. McClure, I can't point to where he addressed that as I stand here.

[00:10:23] Speaker 00:
So if you

[00:10:26] Speaker 02:
Can I ask you about the incorporation by reference?

[00:10:28] Speaker 02:
Yes, Your Honor.

[00:10:29] Speaker 02:
Because you do make that argument.

[00:10:31] Speaker 02:
Yes.

[00:10:32] Speaker 02:
And your adversary says that that doesn't apply in the patent application.

[00:10:37] Speaker 02:
Do you have any cases that you can cite where 157 or 1.57 has been applied in this type of context?

[00:10:43] Speaker 00:
Not specifically, Your Honor.

[00:10:45] Speaker 00:
But we don't have a case that says it doesn't apply in this context.

[00:10:49] Speaker 00:
And on its face, the rule does not say it does not apply.

[00:10:54] Speaker 00:
And then further on incorporation, of course, you've got the advanced display standard.

[00:11:01] Speaker 00:
And we argued, and I'm not going to go through everything in our brief, but we argued that it wasn't a specific enough incorporation.

[00:11:08] Speaker 00:
There was competing documents.

[00:11:10] Speaker 02:
It did raise the question of how specific do you need to be.

[00:11:14] Speaker 02:
Well, in your view, you said?

[00:11:15] Speaker 00:
Yeah, here it says the relevant disclosure is incorporated.

[00:11:19] Speaker 00:
The relevant disclosure of FUJIT is incorporated by reference.

[00:11:23] Speaker 00:
The board found that that was the synthesis of zingolimod hydrochloride.

[00:11:29] Speaker 00:
Okay, so that's example 29, okay?

[00:11:34] Speaker 00:
I looked at it, and this is how we briefed it.

[00:11:36] Speaker 00:
That incorporation appears in a discussion of the prior art.

[00:11:41] Speaker 00:
It's on page one of MUTs.

[00:11:42] Speaker 00:
It's in a discussion of the background section.

[00:11:45] Speaker 00:
And we think that the incorporation may have just as easily been to sort of incorporate the state of the art as many patents do.

[00:11:54] Speaker 00:
And that's non-essential subject matter, state of the art.

[00:11:59] Speaker 00:
a critical synthesis.

[00:12:02] Speaker 00:
Who would incorporate it from a sentence in the background describing the prior art?

[00:12:08] Speaker 00:
And again, how could that possibly square with Mutz's statement that his polymorphs were novel, and that he discovered that this come?

[00:12:17] Speaker 01:
There is no law saying that you cannot incorporate enabling subject matter into your specification, right?

[00:12:25] Speaker 01:
I think maybe that used to previously been something that the PTO required, but that has since changed.

[00:12:36] Speaker 00:
I think you can if it's a U.S.

[00:12:37] Speaker 00:
patent or U.S.

[00:12:38] Speaker 00:
application.

[00:12:41] Speaker 00:
And here, it's sort of the reason I started the way I did, not with incorporation, is regardless of incorporation, the PTAB went on to find

[00:12:53] Speaker 00:
the cryo-art to be enabling.

[00:12:55] Speaker 00:
Okay, and that's – to me, that's the crux of it, and I've given the reasons.

[00:13:00] Speaker 00:
And just briefly, the reasons why, if you accept that you can't go from a compound to a polymorph simply by saying recrystallization, quote-unquote,

[00:13:12] Speaker 00:
Okay, but there was two major errors that the PTab committed in analyzing all of this evidence.

[00:13:20] Speaker 00:
First, the PTab considered all fungolimide hydrochloride basically to be much form one.

[00:13:29] Speaker 00:
Okay, we summarized all those findings at pages 28 and 29 of our opening brief.

[00:13:35] Speaker 00:
Okay, so everything is fungolimide hydrochloride, but we proved that

[00:13:43] Speaker 00:
There are multiple other forms that we're now at pages five to six of our brief we outline There were several forms and we realize this you're using all your rebuttal time.

[00:13:52] Speaker 03:
Do you want to save time?

[00:13:53] Speaker 00:
Yes, I'll say this.

[00:13:55] Speaker 03:
Thank you.

[00:13:55] Speaker 03:
Mr. J, please proceed

[00:14:06] Speaker 04:
Good morning, Your Honors.

[00:14:06] Speaker 04:
May I please support William J. Friend of Artists?

[00:14:09] Speaker 04:
On the place where my friend began, enablement of Mutts, I just want to set the stage by noting, as some of the questions brought out, that this would be a fact question, that there is a presumption that prior art references are enabled.

[00:14:22] Speaker 04:
And so I show up aboard the burden on that point before the board.

[00:14:25] Speaker 02:
Could you just really address, which I think is one of the Plankett-Starr's points, which is that Mutts said and claimed novelty over Adjutant.

[00:14:36] Speaker 02:
So doesn't that imply that Vajita does not teach how to make the form?

[00:14:42] Speaker 04:
I don't think so.

[00:14:43] Speaker 04:
Let me answer that in two steps.

[00:14:46] Speaker 04:
And the thrust of my answer is going to be that MUTs adds to Fujita's disclosure.

[00:14:52] Speaker 04:
In other words, it's not as if MUTs discloses nothing.

[00:14:55] Speaker 04:
Fujita discloses how to make fingolimide hydrochloride.

[00:15:00] Speaker 04:
MUTs discloses how to get from there to the previously not known polymorphic form.

[00:15:05] Speaker 04:
So in other words,

[00:15:07] Speaker 04:
Fujita is not doing all the work and Mutts none of the work.

[00:15:10] Speaker 04:
Fujita adds what our friends on the other side say is this missing step from Mutts, which is synthesis.

[00:15:18] Speaker 04:
But then as the board explains, it does this twice, and I think pages 125 and 131, both in the context of

[00:15:26] Speaker 04:
Fujita and also in the context of Kiuchi, it says it again, that once you're able to make finkolymide hydrochloride, you can use XRPD to conclude what form do you have, and you can raise or lower the temperature to convert what you have into Form I. And so the second point that I was going to make is a more fundamental one.

[00:15:50] Speaker 04:
which is it doesn't matter whether Mutz was itself novel in the sense of whether Mutz was anticipated for it to be a prior art reference that can anticipate this patent.

[00:16:01] Speaker 04:
So, ultimately, I think the question whether Mutz is novel in the sense of being anticipated is sort of a sideshow.

[00:16:08] Speaker 04:
But I think the first part of my answer is the thrust of it, that Fujita or Keiichi could tell you how to make fingolimide hydrochloride, and then you would combine that with Mutz's own teachings about the XRPD profile of Form I, Form II, or Form III,

[00:16:30] Speaker 04:
and the teaching, which is at page 1981, about raising or lowering the temperature for these forms to be interchangeable with each other.

[00:16:38] Speaker 04:
Interchangeable is the wrong word.

[00:16:40] Speaker 04:
Interconvertible by changing the temperature.

[00:16:45] Speaker 04:
So I think that my friend on the other side didn't really deal with Kiyuchi.

[00:16:50] Speaker 04:
A couple important points to note about that is that they had no expert evidence on Kiyuchi either.

[00:16:55] Speaker 04:
So the thrust of their argument was just really that the

[00:17:01] Speaker 04:
If you look at the text of Kayuji, it doesn't say that it's producing the right crystalline form.

[00:17:09] Speaker 04:
And I think the board deals with that.

[00:17:10] Speaker 04:
It's just 130 to 131.

[00:17:12] Speaker 04:
It doesn't matter whether Kayuji itself produces form one.

[00:17:15] Speaker 04:
The question is whether you can use the teachings of Kayuji

[00:17:19] Speaker 04:
combined with what MOTS tells you about the XRPD profile to enable the teaching of MOTS, which is how do I get a size like a polymorph?

[00:17:26] Speaker 02:
And I thank you for your response.

[00:17:27] Speaker 02:
I think your response has laid it out better than the written submission.

[00:17:32] Speaker 02:
So thank you.

[00:17:33] Speaker 04:
I appreciate that.

[00:17:34] Speaker 04:
Thank you, Your Honor.

[00:17:37] Speaker 04:
On the enablement point, that really is the thrust of our point, that this is a reference that's presumed to be enabled, that the board found for two different reasons was enabled, and those findings are supported by substantial evidence.

[00:17:49] Speaker 04:
And we certainly disagree with it.

[00:17:51] Speaker 01:
What about the APA argument that they're making?

[00:17:53] Speaker 04:
So the APA argument is just an argument that the board's decision was arbitrary and capricious because it did not give sufficient discussion to, for example, an important point.

[00:18:05] Speaker 04:
But you will find a discussion of the melting point differences, for example, in the board's decision.

[00:18:14] Speaker 04:
And as I think Judge Brom mentioned to my friend, they credited our experts' conclusions on that point.

[00:18:23] Speaker 01:
I understand that I'm- You did not have to expressly address Dr. Mayo's testimony.

[00:18:29] Speaker 04:
They certainly addressed Dr. Mayo at a number of points, you know, pages 125 and 131 are places where they get into his testimony, where the board gets into his testimony.

[00:18:42] Speaker 04:
Indeed, there was one aspect of his testimony, paragraph 140, where they took to him to be making an admission that was helpful to our side of the case, I think.

[00:18:53] Speaker 04:
read through the testimony.

[00:18:55] Speaker 04:
They weighed the competing expert testimony against each other.

[00:18:59] Speaker 04:
They identified certain aspects where there was no fact dispute, but where there was.

[00:19:10] Speaker 04:
I think it's in page 130, they expressly credit Dr. McClurg, our expert, over Dr. Mayo, their expert.

[00:19:16] Speaker 04:
And on this melting point point, we don't need to establish that all thingolimod in the world is thingolimod hydrochloride form one or form beta at a particular temperature.

[00:19:33] Speaker 04:
We just need to establish that mods

[00:19:36] Speaker 04:
had possession of, or much teaches, form one.

[00:19:40] Speaker 04:
And that form one, at room temperature, is the same as the claim to form beta.

[00:19:44] Speaker 04:
And that's what the board made a classically scientific finding on a classic expert dispute.

[00:19:51] Speaker 04:
They refereed the dispute, and they came out in our favor.

[00:19:55] Speaker 04:
I think those are the points that I wanted to make about Mutts and Keiuchi and Fujita, unless the court has questions about any of the other issues.

[00:20:06] Speaker 02:
I have a question about peak four.

[00:20:07] Speaker 04:
Of course.

[00:20:08] Speaker 02:
Yeah.

[00:20:09] Speaker 02:
So if I'm understanding this correctly.

[00:20:12] Speaker 02:
It's your position that the DSC peaks merely describe behavior, right?

[00:20:17] Speaker 04:
I would say properties.

[00:20:19] Speaker 02:
And they're just properties of a compound that can be disregarded, right?

[00:20:23] Speaker 02:
Right so far?

[00:20:24] Speaker 04:
Yes.

[00:20:24] Speaker 04:
OK.

[00:20:25] Speaker 04:
At least for peak four.

[00:20:28] Speaker 04:
That's the only peak we're talking about.

[00:20:29] Speaker 04:
And I'm not making so broad a statement as that no DSC peak is ever relevant.

[00:20:34] Speaker 02:
Well, that's not my question is how far going out do these DSC peaks?

[00:20:41] Speaker 02:
Your argument, in this case, is one thing, but what would be the ramifications in other patents?

[00:20:49] Speaker 02:
Are they ever patentable claim limitations?

[00:20:51] Speaker 04:
I think they could be.

[00:20:54] Speaker 04:
And so the only thing that the board held here is that this peak, which remember, so the claim language is to crystalline form beta.

[00:21:04] Speaker 04:
Once you've gotten up to the temperature at which you would find peak four, we're no longer dealing with crystalline form beta.

[00:21:11] Speaker 01:
It's like a nothing.

[00:21:11] Speaker 04:
It's a liquid that has lost its crystalline characteristics.

[00:21:16] Speaker 04:
And I think the right word is that birefringence, which is the aspect of crystals that splits light, has disappeared at 230 degrees.

[00:21:25] Speaker 04:
And we're well above that.

[00:21:27] Speaker 04:
So the board said appropriately in the sort of first of its two points on this question that it isn't even really a property of crystalline form beta that we're talking about up at form four – sorry, up at peak four.

[00:21:41] Speaker 04:
Now, that wouldn't be true of the lower peaks, and so it might well be the case that you could describe

[00:21:47] Speaker 04:
You could identify a polymorph by saying this is the temperature at which that polymorph shifts to the next one, which in this case would be shifting from solid form one to solid form two as taught in MUTs.

[00:21:59] Speaker 04:
But of course that peak is disclosed in MUTs, so that doesn't help you understand.

[00:22:04] Speaker 01:
serious issue with that part of the board's opinion, because to me that might indicate an inconsistency in the claim that causes some sort of indefiniteness problem.

[00:22:14] Speaker 01:
But to say that you can just ignore that limitation, I don't know of much case law that would support that.

[00:22:21] Speaker 01:
And let me further just elaborate that I read Wilder and some of these other cases as more more aptly saying that you don't

[00:22:30] Speaker 01:
Those limitations aren't going to change whether a claim is novel or not, because the property that is being described is likely inherent in the composition that was already known.

[00:22:46] Speaker 01:
And that that is a more consistent way to describe it with our case law, rather than saying we can just ignore a claim limitation.

[00:22:54] Speaker 01:
What do you think of that?

[00:22:55] Speaker 04:
So let me focus in on whether Wilder and Inherency are the same thing, because I think that's really the thrust of your question.

[00:23:02] Speaker 04:
I don't see them as being exactly the same thing.

[00:23:04] Speaker 04:
In this case, they would get to the same point.

[00:23:07] Speaker 04:
But of course, the board didn't reach.

[00:23:09] Speaker 04:
And we did argue Inherency in the alternative.

[00:23:10] Speaker 04:
The board didn't reach it.

[00:23:12] Speaker 04:
The reason I don't think they're the same thing is because of the discussion in Wilder and Titanium and Spada about the fact that this is a rule about composition of matter claims specifically, whereas inherency obviously is a broader principle about the law of anticipation for any type of prior art.

[00:23:33] Speaker 04:
and any type of claim.

[00:23:35] Speaker 04:
But the principle is that you can't take a compound that's in the public domain, like it's been disclosed in the prior art, and make it patentable by disclosing a property, even a previously unknown and non-obvious property that that compound has.

[00:23:52] Speaker 01:
Is it because that property would have, even if it wasn't known, would have been necessarily part of the composition?

[00:24:02] Speaker 04:
I think that as a factual matter, that's going to be true.

[00:24:08] Speaker 04:
But as a matter of this court's law and things like burdens and quantum of evidence, I think that the court in Wilder and Titanium saw it not as inherency, but as

[00:24:25] Speaker 04:
an aspect of the law of anticipation for composition of matter claims.

[00:24:32] Speaker 04:
Once you have the composition of matter, we've established what

[00:24:37] Speaker 04:
I'm oversimplifying here, but what atoms in what arrangement and what conditions, then how it behaves, whether that's corrosion resistance, as in titanium, or non-irritation, as in wilder, or having a dissociation peak, like peak four.

[00:24:59] Speaker 04:
Those are just aspects of the compound that don't make an anticipated compound.

[00:25:07] Speaker 04:
patentable again.

[00:25:08] Speaker 04:
And I think in this case, I think this just gets back to my answer to Judge Brown about how broadly are we asking you to rule.

[00:25:17] Speaker 04:
And the answer is not broadly at all, because in this case, it is not as if

[00:25:25] Speaker 04:
Mutz said, and there is no peak up at where peak four is.

[00:25:30] Speaker 04:
It just doesn't just expressly disclose peak four.

[00:25:34] Speaker 04:
And there are factual reasons in the context of this compound at this temperature using this experimental method and so on why you might well expect that the Mutz experiment just didn't do DSC up to peak four.

[00:25:49] Speaker 04:
But we put in evidence for why

[00:25:52] Speaker 04:
Nonetheless, that is where that molecule begins to dissociate.

[00:25:58] Speaker 04:
And nothing about that has to do with the fact that you started at Form 1 down at room temperature, if that makes sense.

[00:26:09] Speaker 04:
Unless the court has any further questions about either this point or claim construction or anything else?

[00:26:17] Speaker 02:
No.

[00:26:17] Speaker 02:
Thank you, Your Honor.

[00:26:30] Speaker 00:
Briefly, just to wrap up the enablement, I was saying all of

[00:26:36] Speaker 00:
Fingolimide hydrochlorides and not MUTs form 1.

[00:26:39] Speaker 00:
Take a look, please, at pages 5 to 6 of our opening brief.

[00:26:43] Speaker 00:
We list many different polymorphs of Fingolimide hydrochloride.

[00:26:48] Speaker 00:
Second, it's not accurate to say that simply cooling Fingolimide hydrochloride gives you MUTs form 1.

[00:26:56] Speaker 00:
All that MUT says, and this is at appendix page 1983, is that if you cool form 2 or form 3,

[00:27:04] Speaker 00:
you can get back to form one.

[00:27:06] Speaker 00:
So if you start with form one and heat and you get two or three, you can cool and get back.

[00:27:11] Speaker 00:
It's not cooling any Fingolimod hydrochloride gives you once form one.

[00:27:16] Speaker 00:
And Kiuchi simply taught another way to make Fingolimod hydrochloride than Fujita.

[00:27:24] Speaker 00:
But that's not form one, the same as Fujita is not.

[00:27:28] Speaker 00:
And what the board said at 130 to 131 is that because MUX teaches that form one is obtained by cooling fengolamide hydrochloride below 40 degrees C, that has nothing to do with Kiyuchi.

[00:27:44] Speaker 00:
Kiyuchi wasn't heating anything.

[00:27:45] Speaker 00:
And cooling what Kiyuchi got would not give you much form one.

[00:27:50] Speaker 00:
In terms of anticipation, we'll stand on our brief in terms of peak four being improperly removed from the claims and there is evidence showing that at the high temperatures of 265, 270 different polymorphs give different results.

[00:28:12] Speaker 00:
In 816, you get an endothermic peak.

[00:28:14] Speaker 00:
When Mutz tested his Form 1 back in the olden days, he got a different peak.

[00:28:19] Speaker 00:
And the 005 patent we briefed also shows different peaks at that temperature.

[00:28:24] Speaker 00:
One is exothermic.

[00:28:26] Speaker 00:
The other showed no peak at that temperature.

[00:28:28] Speaker 00:
Thank you, Your Honors.

[00:28:29] Speaker 03:
I thank both counsel.

[00:28:31] Speaker 03:
This case is taken under submission.