[00:00:35] Speaker 04:
We will hear argument next in number 161352, Novartis against Torrent.

[00:00:43] Speaker 04:
Before you get started and before the clock starts, I would like to ask the parties after this argument to review the confidentiality designations in the joint appendix, try to agree if there are portions, as they certainly appear to us to be, that

[00:01:05] Speaker 04:
Do not now, if they ever did, need confidentiality designations.

[00:01:09] Speaker 04:
There appear to be whole filings in the PTO in which you set out the proposed amendments and arguments that do not seem to need confidentiality designations and try to agree on what such material might be declassified, if I can use that word, and let us know in any way that you think is suitable.

[00:01:34] Speaker 04:
And we do not plan to adjudicate disputes about this.

[00:01:38] Speaker 04:
Understood, Your Honor.

[00:01:40] Speaker 03:
Yes, and we will, of course, do that, Your Honor.

[00:01:43] Speaker 03:
Good day, and may it please the Court.

[00:01:45] Speaker 03:
My name is Robert Trencher.

[00:01:46] Speaker 03:
I'm from Gibson, Dunn, and Crutcher.

[00:01:49] Speaker 03:
I'm speaking today for the appellants in this appeal of the PTAP's decision in validating a patent on the formula for gillenia, the world's first approved solid oral medication for multiple sclerosis.

[00:02:02] Speaker 03:
As the briefs show, the board made several legal errors, but I'd like to focus my time today on the board's failure to provide the notice and chance to be heard required by the APA on the reference that really was the centerpiece of their final written decision, the Sakai patent.

[00:02:20] Speaker 03:
In addition to time permits, I would like to address how the board handled the nexus issues with respect to secondary indicia, but we'll see if we get there.

[00:02:31] Speaker 03:
The Sakai patent covered a liquid formula that contains the same active ingredient as Jelena.

[00:02:40] Speaker 03:
It's called Fingolumab.

[00:02:43] Speaker 03:
And it was designed to be injectable primarily, although there was more.

[00:02:48] Speaker 01:
We are familiar with the reference and probably presume that and just jump into why it is that

[00:02:55] Speaker 01:
You should have a remand down to the board when in fact, Sakai was discussed in briefing and at the oral argument before the board.

[00:03:07] Speaker 03:
Yes, your honor.

[00:03:08] Speaker 03:
So after the board's institution decision, it found of course that Sakai was inapplicable to the solid formula that's in R283 patent.

[00:03:18] Speaker 03:
That was their word, inapplicable.

[00:03:20] Speaker 03:
Because you don't look too liquid to make a solid.

[00:03:23] Speaker 03:
Based on that decision,

[00:03:25] Speaker 03:
They rejected two Sakai-based proposed grounds in the petition.

[00:03:32] Speaker 03:
And they ordered the parties in the decadal paragraph, the institution decision.

[00:03:35] Speaker 05:
One was just based on Sakai alone, right?

[00:03:38] Speaker 03:
Correct.

[00:03:38] Speaker 03:
One was anticipation.

[00:03:39] Speaker 05:
My understanding is the board said, well, we're not going to institute on a 102, since the Sakai reference is a liquid formulation.

[00:03:48] Speaker 05:
And as we understand the claim, it's calling for a solid.

[00:03:51] Speaker 05:
So it can't be a 102.

[00:03:53] Speaker 05:
Correct.

[00:03:54] Speaker 05:
But that doesn't speak to why it can't be used as a possible basis for combining Chiba and Alton.

[00:04:01] Speaker 03:
However, with respect to the 103 ground that was proposed was a combination of Sakai and Chiba.

[00:04:07] Speaker 03:
And in that discussion, the board and the institution decision said that Sakai as a liquid is inapplicable to a solid.

[00:04:15] Speaker 04:
And the reason is pretty straightforward.

[00:04:16] Speaker 04:
Let me just quote it, because it seems to me that the thing in the board decision that you

[00:04:23] Speaker 04:
to rely on for what makes this case at least possibly distinctive.

[00:04:29] Speaker 04:
This is on A, appendix 72, page 13 of the words opinion.

[00:04:33] Speaker 04:
Sakai's stated reasons for using mannitol in liquid pharmaceutical compositions are inapplicable to its potential use in connection with solid pharmaceutical compositions.

[00:04:44] Speaker 04:
And as I understand your argument in its most pointed form is you were entitled to rely on that

[00:04:52] Speaker 04:
as essentially a binding toward disposition of a factual proposition wherever that factual proposition might be used, including in the ground on which the IPR was instituted, CHICA plus... CHICA plus often, yes, Your Honor.

[00:05:18] Speaker 03:
I would modify what Your Honor said slightly in that we view it as the law of the case.

[00:05:22] Speaker 03:
So we did think the board, if it wanted to.

[00:05:23] Speaker 04:
You know, I went on the computer and looked, and at least I did not find any IPR board reference ever to law of the case.

[00:05:34] Speaker 03:
Yes, Your Honor.

[00:05:35] Speaker 03:
This is a sui generis group of facts.

[00:05:39] Speaker 03:
We have never seen a situation in which the board makes an affirmative finding at the institution stage that results in final non-appealable action.

[00:05:48] Speaker 04:
How would this work in a district court, say, in a preliminary injunction proceeding, where on a limited record the district court says, I don't think that this is relevant to this other thing.

[00:06:04] Speaker 04:
A is not relevant to B.

[00:06:06] Speaker 04:
Would law of the case apply in the trial?

[00:06:10] Speaker 04:
I understand there are different procedural rules, but would that apply to essentially require the special high standards that law of the case

[00:06:21] Speaker 04:
triggers for changing the court's mind?

[00:06:26] Speaker 03:
In a preliminary injunction context in district court, all those findings are quite expressly preliminary.

[00:06:33] Speaker 04:
All of them.

[00:06:33] Speaker 04:
But why aren't all of these quite implicitly?

[00:06:37] Speaker 03:
Well, it's much like the SAS case, Your Honor.

[00:06:39] Speaker 03:
In the SAS case, which was earlier this year, in which this court found that a board determination on claim construction at the institution stage

[00:06:50] Speaker 03:
that the board then switched in the final written decision was a problem because the parties had relied on the plan constructions.

[00:06:57] Speaker 01:
Isn't that in that case is different though if the parties relied on it but they also the board changed that construction and the parties hadn't argued over it they didn't have notice that the board was going to change that construction.

[00:07:12] Speaker 01:
Whereas here it seems to me that it might be different in that the parties in this case seem to have discussed

[00:07:20] Speaker 01:
We're in great detail in different briefings exactly whether Sakai is support for the combination that the board was examining.

[00:07:29] Speaker 03:
That's actually not correct, Your Honor.

[00:07:30] Speaker 03:
We did not do that.

[00:07:31] Speaker 03:
What we did is we took the board's decision as given.

[00:07:36] Speaker 03:
And to the extent Sakai came up in subsequent proceedings, which it did, we put in basically the same conclusory point that the board had.

[00:07:43] Speaker 03:
We did not develop the record as we would have.

[00:07:46] Speaker 03:
And as the board found actually was missing,

[00:07:49] Speaker 05:
One of the strange things about this case is... Didn't Dr. Byrne provide a declaration that commented on the other side's theories on why, in their view, Sakai was relevant to a combination of Cheap and Alton, and then Dr. Byrne tried to explain away why that's not necessarily so?

[00:08:06] Speaker 03:
Dr. Byrne submitted two declarations.

[00:08:08] Speaker 05:
We're talking about the second one.

[00:08:10] Speaker 03:
Okay, so, a patent owner, of course, in this sort of proceeding, has one shot to put in an affirmative case that's not rebuttable.

[00:08:17] Speaker 03:
And that's with the patent owner's opposition and with the motion to amend.

[00:08:21] Speaker 03:
Go in at the same time.

[00:08:22] Speaker 03:
That is our only chance to put in affirmative evidence.

[00:08:26] Speaker 03:
The other side, on the motion to amend.

[00:08:27] Speaker 04:
So when Judge Shen was describing, was he describing something?

[00:08:30] Speaker 03:
On the motion to amend.

[00:08:32] Speaker 03:
That's about the motion to amend.

[00:08:33] Speaker 03:
Correct.

[00:08:33] Speaker 03:
That is a reply declaration on the motion to amend alone.

[00:08:39] Speaker 03:
That's entirely what it was about.

[00:08:41] Speaker 03:
And even there, to the extent it addresses this question,

[00:08:45] Speaker 03:
of whether a reasonable formulator at the time would look to this Sakai patent, this liquid, in order to make a solid.

[00:08:52] Speaker 03:
If you read the declaration, all it does is parrot what the board had already found, which is you wouldn't do that because the ingredients in Sakai, mannitol that overlaps with the ingredient in our patent, are used for completely different reasons.

[00:09:05] Speaker 03:
In Sakai patent, mannitol is used to alleviate injection site irritation.

[00:09:10] Speaker 03:
That's obviously not an issue when you put a pill in your mouth.

[00:09:12] Speaker 03:
You don't have any injection site irritation.

[00:09:14] Speaker 03:
So you wouldn't look to Manital as used in a liquid.

[00:09:18] Speaker 05:
To me, it looks like A30 to A37 says more than just parroting the sentence from the institution decision.

[00:09:24] Speaker 03:
He doesn't quote the sentence, Your Honor.

[00:09:25] Speaker 05:
It's all about a formulator would not refer to Sakai to make a solid oral formulation if you can call him.

[00:09:30] Speaker 03:
Exactly, Your Honor, which is the conclusion that the board had reached at the beginning.

[00:09:34] Speaker 03:
And the reasoning he uses is exactly the same reasoning that the board used in its institution decision.

[00:09:39] Speaker 03:
He did not go into any more depth.

[00:09:42] Speaker 03:
At, frankly, the motion to amend stage on the reply, he wasn't allowed to go into any more depth at that point in time.

[00:09:48] Speaker 03:
Under the rules, if we had tried to introduce anything new about why a formulator wouldn't look to Sakai when making our solid formula, the whole reply would have been subject to being struck under the board's rules.

[00:10:02] Speaker 03:
The entire reply, because the board says we're not going to parse what's new versus what's not new.

[00:10:06] Speaker 03:
Of course, the other side did not move the strike because we introduced nothing new in those paragraphs.

[00:10:12] Speaker 04:
Can I try to define what you argue is distinctive?

[00:10:20] Speaker 04:
But put aside that one sentence which I read earlier.

[00:10:24] Speaker 04:
And let's pretend that doesn't exist.

[00:10:27] Speaker 04:
And so the board's institution decision says,

[00:10:31] Speaker 04:
We're not going to institute anticipation by Sakai.

[00:10:34] Speaker 04:
We're not going to institute 103 Chiba plus Sakai.

[00:10:38] Speaker 04:
There had been reference in the petition to, let's call it background use of Sakai for the Chiba plus the other way.

[00:10:48] Speaker 04:
Alton.

[00:10:49] Speaker 04:
Alton, yeah.

[00:10:51] Speaker 04:
At that point, would you have any argument that,

[00:10:56] Speaker 04:
the board couldn't rely on Sakai as part of the background for deciding whether there was motivation to combine Chiba and Alvin?

[00:11:09] Speaker 03:
In this instance, Your Honor, given how Sakai was actually used, it was not used as background art.

[00:11:14] Speaker 03:
When you read the final decision, it's Sakai directly teaches, directly instructs.

[00:11:19] Speaker 03:
That's a primary reference that should be in what used to be called the count and is now called the graph.

[00:11:23] Speaker 04:
But it's one of four or five

[00:11:26] Speaker 04:
It's in a passage, right, where the board says, here are a variety of reasons that we think somebody would, in fact, have looked to Alton to use Chiba.

[00:11:37] Speaker 03:
What the board does is first it looks at the two instituted references, Chiba and Alton, and it says those together would give rise to a motivation to test, to look at the anatom, but not actually use it.

[00:11:49] Speaker 03:
And we had a whole bunch of fighting below about how that's just an obvious to try argument in the context where that can't be blocked.

[00:11:55] Speaker 03:
That's the first filing.

[00:11:57] Speaker 03:
The next page, you turn the page, and it talks about all of Sakai.

[00:12:00] Speaker 03:
Sakai is the missing link that they rely on for motivation to combine.

[00:12:04] Speaker 03:
And under the Biedermann case, that changed the entire thrust of the proceeding, right there.

[00:12:09] Speaker 03:
And that is our fundamental problem with how they use Sakai.

[00:12:12] Speaker 03:
So our view is that the inapplicable language...

[00:12:16] Speaker 04:
How your argument would be the same even if the board had not had that sentence that's actually said, inapplicable, wouldn't that be a problem under the recent Genzyme case?

[00:12:26] Speaker 03:
Our argument is stronger because the inapplicable language was there, but we would still have and still make the argument that they ended up using Sakai as a primary reference when it wasn't a ground that was instituted.

[00:12:38] Speaker 03:
I think this is quite different than Genzyme, Your Honor.

[00:12:40] Speaker 03:
In Genzyme, there was no reference at the institution stage to the in vivo papers that ended up getting injected into that case.

[00:12:50] Speaker 03:
Then the patent owner in his opposition introduced those, but then said you can't look at them instead of dealing with them substantively.

[00:12:58] Speaker 03:
And I think the court rightly said, you had notice.

[00:13:00] Speaker 03:
You brought them into the proceeding.

[00:13:01] Speaker 03:
You could use them.

[00:13:03] Speaker 03:
That's a very different context here.

[00:13:05] Speaker 03:
Here, we had a finding at the beginning, and an order

[00:13:08] Speaker 03:
to limit our presentation to the references that were instituted.

[00:13:13] Speaker 03:
And Sakai had been excluded not once, but twice on a 102 and a 103 basis.

[00:13:17] Speaker 04:
Well, Sakai had been excluded.

[00:13:19] Speaker 04:
I'm not quite sure what that means.

[00:13:20] Speaker 04:
There were two grounds of alleged invalidity that included Sakai on which the board didn't institute.

[00:13:30] Speaker 04:
But am I wrong that the petition relied in part on Sakai in the ground, in its argument for the ground on which

[00:13:39] Speaker 04:
the proceeding was instituted?

[00:13:40] Speaker 03:
That's a very interesting question, Your Honor.

[00:13:42] Speaker 03:
We addressed this in our reply brief.

[00:13:44] Speaker 03:
The petition cited Sakai on the reasonable expectation of success question, not a motivation to combine cheap and ultimate.

[00:13:52] Speaker 03:
So it was a completely different issue than the issue on which the board seized on it and used it in the final decision.

[00:13:59] Speaker 03:
So even relying on the petition, I would argue that given the board's finding in the institution decision,

[00:14:05] Speaker 03:
whatever the petition said about Sakai has to be viewed in light of what the board thought of it at the institution stage.

[00:14:11] Speaker 03:
But even if you look at the petition, Sakai was in the reasonable expectation of success analysis, not in the motivation to combine analysis.

[00:14:17] Speaker 03:
I do see I'm eating very much into my rebuttal time.

[00:14:21] Speaker 04:
If you have something else you want to talk about briefly, go ahead.

[00:14:25] Speaker 03:
I won't reserve.

[00:14:26] Speaker 03:
You won't lose your time.

[00:14:28] Speaker 03:
Oh, I appreciate it, Your Honor.

[00:14:30] Speaker 03:
I think we've touched on all the key parts about Sakai.

[00:14:34] Speaker 03:
The most important thing is we would have put in an affirmative case if we had known Sakai was a live issue.

[00:14:41] Speaker 03:
The board itself identifies the type of analysis that we would have done if we had known Sakai was a live issue, rather than simply putting in conclusory points based on the board's initial finding.

[00:14:52] Speaker 03:
We would have, for instance, in this article by Dr. Byrne, explained why the active ingredient fengalamod was a very poor candidate for being extrapolated in its liquid form to a formula in its solid form.

[00:15:03] Speaker 03:
There was a quote

[00:15:05] Speaker 03:
in the Alton reference, the instituted reference, in which that formulator that they are relying on, Mr. Alton or Dr. Alton, says you can't, his words, glibly extrapolate formulas created in solution to a solid form.

[00:15:20] Speaker 03:
So their own reference was describing what Dr. Kent, their expert, was doing as glib.

[00:15:25] Speaker 03:
We would have brought that sort of information out.

[00:15:26] Speaker 03:
We would have looked at other literature as to why you don't do this sort of thing.

[00:15:31] Speaker 03:
And we never had that chance.

[00:15:32] Speaker 03:
And we're just asking for that opportunity when we hopefully go back.

[00:15:35] Speaker 03:
That's it, Your Honor.

[00:15:36] Speaker 04:
Okay, thank you.

[00:15:38] Speaker 04:
Restore the rebuttal time.

[00:15:47] Speaker 04:
Ms.

[00:15:47] Speaker 04:
Ray.

[00:15:48] Speaker 00:
Thank you.

[00:15:49] Speaker 00:
Good morning, Your Honors.

[00:15:50] Speaker 00:
I'm Terry Ray.

[00:15:52] Speaker 00:
I'm with Crowley Mooring, and I'm arguing on behalf of petitioners today.

[00:15:59] Speaker 00:
I believe that what is at issue right now is the decision by the Patent Trial and Appeal Board and their determination of the claims of the 283 patent were unpatentable because they claimed no more than an obvious combination of two solid oral, of two ingredients in a solid oral formulation.

[00:16:18] Speaker 04:
Can you focus on this particular passage at Appendix 72 in the institution decision in which the board says

[00:16:26] Speaker 04:
Sakai's stated reasons for using mannitol in liquid pharmaceutical compositions are inapplicable to its potential use in connection with solid pharmaceutical compositions.

[00:16:37] Speaker 04:
And try to explain what we should make of that, why that was not in effect enough of a closing of that issue unless it were affirmatively reopened that Novartis could rely on it.

[00:16:57] Speaker 00:
Yes, Your Honor.

[00:16:57] Speaker 00:
So that particular passage I am very familiar with.

[00:17:02] Speaker 00:
And keep in mind that passage was made during the institution decision.

[00:17:06] Speaker 00:
And basically, the only focus at that time was on the three grounds that petitioners had presented.

[00:17:13] Speaker 00:
You've already discussed them.

[00:17:14] Speaker 00:
One was a 102 and then two 103 grounds.

[00:17:17] Speaker 00:
So when they said it was inapplicable, it was inapplicable only for use as a primary anticipation or obviousness reference.

[00:17:26] Speaker 00:
The fact of the matter is, at the institution... I'm not sure that really says that.

[00:17:33] Speaker 04:
This doesn't say that Sakai is inapplicable.

[00:17:36] Speaker 04:
It says that Sakai's stated reasons for using the mannitol in liquid are inapplicable to potential use in solid.

[00:17:46] Speaker 04:
That sounds like a

[00:17:48] Speaker 04:
factual finding, maybe not forever binding that precludes the board from changing its mind, but why isn't that enough to have allowed Novartis to rely on it unless they were given further notice with an opportunity to put on evidence?

[00:18:07] Speaker 05:
Let me see if I can put a finer point on it.

[00:18:10] Speaker 05:
A72, page 13 of the institution's decision

[00:18:16] Speaker 05:
as Judge Toronto points out, says the stated reasons for using mannitol in liquid is inapplicable to its potential use in a solid.

[00:18:27] Speaker 05:
And then A-12, the board points out that Sakai contemplates the use of mannitol only for use in liquid pharmaceutical compositions.

[00:18:38] Speaker 05:
Sakai teaches using that results in a liquid composition further improved in irritation.

[00:18:45] Speaker 05:
And so

[00:18:46] Speaker 05:
I'm trying to figure out if the board is trying to say here that the reasons for using mannitol and liquid were to avoid irritation problems and that suggested usage doesn't quite apply to a solid because you don't have to worry about that.

[00:19:07] Speaker 05:
But nevertheless, I'm trying to figure out if there's daylight between that and the ultimate usage of

[00:19:14] Speaker 05:
the Sakaya reference as supporting this particular rejection.

[00:19:18] Speaker 00:
So I don't know if the PTAD made that decision based on the irritation problems, but I can tell you that their focus at the time was indeed just on establishing the grounds and the conditions.

[00:19:32] Speaker 00:
And if Judge Toronto, as you mentioned, if you took that as a factual determination, that it's completely irrelevant, by the time we had the actual trial and we had a robust record,

[00:19:43] Speaker 04:
Even one of Novartis' technical experts, Dr. Byrne, B-Y-R-N, he actually had an article... The problem, I mean, I sort of understand in the normal district court settings, you say you have a preliminary proceeding and then you go to the trial and both sides...

[00:20:00] Speaker 04:
now have a full opportunity on whatever the current pleadings are to put on their evidence.

[00:20:06] Speaker 04:
The problem is that they go first after the institution decision.

[00:20:11] Speaker 04:
And the question is, what is it that reasonably defines what they are supposed to put on affirmative evidence for?

[00:20:20] Speaker 04:
Because they are not at least entitled to another chance.

[00:20:24] Speaker 04:
And so the stuff that they tried to do after you came back and said, Sakai, Sakai, Sakai,

[00:20:30] Speaker 04:
making this up.

[00:20:33] Speaker 04:
That's not quite the opportunity.

[00:20:36] Speaker 00:
So when they had their first opportunity after the institution decision, keep in mind that also within one month after institution, two additional parties joined torrent.

[00:20:47] Speaker 00:
One of them was Apotex.

[00:20:49] Speaker 00:
One was Mylan.

[00:20:50] Speaker 00:
They both accepted the Chiba Alton ground for unpatentability.

[00:20:55] Speaker 00:
But they also mentioned Sakai as well as other background references in their analysis.

[00:21:01] Speaker 00:
It was months after that, after there were depositions, after Pat and owner had to provide their reply.

[00:21:08] Speaker 00:
And Pat and owner was on more than adequate opportunity or notice to know that Sakai is one of many background references.

[00:21:15] Speaker 00:
And De Vargas handled it in that fashion throughout the trial proceeding.

[00:21:20] Speaker 04:
Do you happen to have the citation at hand to the Apotex Mylan petition?

[00:21:26] Speaker 00:
My colleagues will.

[00:21:28] Speaker 00:
Thank you so much.

[00:21:31] Speaker 00:
Generally, when parties join an earlier IPR proceeding, there is substantial duplication in the IPR itself.

[00:21:41] Speaker 04:
No, but I take it what you are suggesting is significant is that after the institution decision, there was another pleading to which they now had to respond that re-invokes SECHI in exactly the way that you then came to use it.

[00:21:57] Speaker 00:
That's correct, Your Honor.

[00:21:58] Speaker 04:
I take it that's your point.

[00:22:01] Speaker 00:
Appendix 20788.

[00:22:05] Speaker 00:
20788?

[00:22:05] Speaker 00:
Yeah, to 89.

[00:22:07] Speaker 00:
Thank you.

[00:22:10] Speaker 00:
We believe that Novartis had plenty of opportunity to discuss Sakai in any way that they wished.

[00:22:24] Speaker 00:
Even during the oral proceedings, at the very beginning of their demonstratives,

[00:22:29] Speaker 00:
They put in two slides on Chiba, one slide on Alton, two slides on Sakai.

[00:22:37] Speaker 00:
They continuously referred to Sakai throughout all of their written proceedings where page limits are very precious and limited and valuable.

[00:22:47] Speaker 01:
What about their point that law and the case applies here?

[00:22:51] Speaker 01:
That that was a finding that they could rely on and that the PTAB can't change their mind.

[00:22:56] Speaker 00:
I don't think that the PTAP changed their mind.

[00:22:58] Speaker 00:
I think that their reliance, if indeed it was on that one sentence, was inappropriate.

[00:23:04] Speaker 00:
Because everybody knows that there are background references that are discussed during depositions as well as on papers.

[00:23:10] Speaker 00:
And that background references helped to add to the robustness of the case.

[00:23:14] Speaker 00:
And if that wasn't the case, we wouldn't have a trial at the institution decision would be the decision.

[00:23:22] Speaker 01:
Well, let me ask you this.

[00:23:23] Speaker 01:
You disagreed with whether the PTAB changed its mind.

[00:23:26] Speaker 01:
Let's just say they did.

[00:23:28] Speaker 01:
Let's say there really was a situation where they say something in the institution decision, then they say something exact opposite.

[00:23:34] Speaker 01:
in their final decision.

[00:23:36] Speaker 01:
But the parties argue about this finding anyway.

[00:23:39] Speaker 01:
I mean, does law of the case really apply?

[00:23:42] Speaker 01:
Because in district court, I don't think it would.

[00:23:44] Speaker 01:
And the reason why is because law of the case doesn't apply until there's an appeal.

[00:23:48] Speaker 01:
Someone fails to appeal, and then you end up going back on remand.

[00:23:51] Speaker 01:
So I'm just trying to figure out, when would law of the case apply in the PTAB?

[00:23:55] Speaker 00:
Probably only after perhaps an appeal as you indicated but the fact of the matter is we don't have to arrive at that right now because Sakai frankly was not even necessary to supporting that ground and to focus on the unpatentability of the claims.

[00:24:13] Speaker 00:
If we didn't have Sakai in the case,

[00:24:15] Speaker 00:
which I almost regret now that we had brought it up, if we didn't need Sakai at all, I think we would have won no matter what.

[00:24:22] Speaker 00:
So now that we have Sakai in the case, and it was always there as a background reference, now suddenly, Novartis is saying, aha, because of that inapplicable language that Judge Toronto pointed out in the institution decision, that now somehow they did not have a full, robust opportunity to really build their record as to Sakai.

[00:24:44] Speaker 00:
I maintain that even if

[00:24:45] Speaker 00:
There's anything else they wanted to add to Sakai.

[00:24:48] Speaker 00:
It would either be inconsistent, redundant, or unnecessary to arrive at a different decision.

[00:24:54] Speaker 00:
If there was any problem here at all.

[00:24:55] Speaker 04:
But what in the board's decision would make it clear to us that the board thinks the same way you just said you think about how ultimately immaterial Sakai is?

[00:25:10] Speaker 00:
The board doesn't usually look at a reference and say it's irrelevant for the rest of the proceeding.

[00:25:15] Speaker 00:
When the board in their institution decision looks at references, it's only in terms of the grounds for unpatentability.

[00:25:24] Speaker 00:
They don't say, by the way, there's six other background references mentioned in the petition.

[00:25:30] Speaker 00:
And three of those, we don't want to hear any more than the proceeding.

[00:25:34] Speaker 00:
Because the board can't say that.

[00:25:35] Speaker 00:
They don't know that at that point.

[00:25:38] Speaker 04:
Right, but that's why I guess I keep focusing on that one sentence at Appendix 72, without which I think

[00:25:45] Speaker 04:
what you're just saying would track perfectly.

[00:25:48] Speaker 04:
But that's a bit of a bump in the road.

[00:25:51] Speaker 04:
That sounds, when you read it by itself, like the board is saying, this one we have made a factual determination about.

[00:26:03] Speaker 00:
But they didn't explicitly say that.

[00:26:06] Speaker 00:
And when we read it, we did not take it to be read as definitively as we never want to hear about this reference again.

[00:26:13] Speaker 00:
And likewise, Novartis did not interpret it in that fashion.

[00:26:17] Speaker 00:
Novartis kept using their precious page numbers on Sakai, and if they thought it wasn't part of the record, they wouldn't have done so.

[00:26:25] Speaker 00:
Novartis also had a wonderful opportunity in their motion to exclude toward the very end to make it clear what their feelings were or their impressions were on Sakai, especially with respect to that language that you just provided.

[00:26:40] Speaker 00:
And they did not do so.

[00:26:41] Speaker 00:
So they had plenty of

[00:26:43] Speaker 00:
self-help opportunities throughout the entire trial to clarify the record, to bring it to the board's attention, and to let everybody know how they felt.

[00:26:52] Speaker 00:
And they did not do so.

[00:26:53] Speaker 00:
And even through the oral hearing, Sakai is mentioned throughout the record.

[00:26:59] Speaker 00:
And they never objected.

[00:27:01] Speaker 00:
If they really believed it, they would have said, Sakai is not a reference we need to address at that time.

[00:27:07] Speaker 00:
And they failed to do so.

[00:27:14] Speaker 00:
I still have a few more minutes.

[00:27:16] Speaker 00:
Is there anything more that you would like to hear?

[00:27:20] Speaker 04:
Can you talk a little bit about what the board said about unexpected results, and in particular with reference to the several dependent claims that

[00:27:37] Speaker 04:
speak of certain concentrations of the active ingredient and the mannitol.

[00:27:45] Speaker 04:
And the board, if I recall, addressed that once kind of in general in going through the various non-art considerations, and then also addressed it briefly in passing in discussing the motion to amend with respect to, I think, proposed claim 40 or something like that.

[00:28:07] Speaker 00:
OK, yes, your honor.

[00:28:09] Speaker 00:
So the issue is low dose versus low concentration.

[00:28:16] Speaker 00:
And the issue as to low dose was first brought to the board's attention during the oral hearing.

[00:28:21] Speaker 00:
That was not something that was vetted significantly below.

[00:28:25] Speaker 00:
But even so, low concentration was never mentioned before the PTAB.

[00:28:33] Speaker 00:
Only once they decided to take their appeal

[00:28:35] Speaker 00:
Did they carefully review the exact claims of the 283 patent?

[00:28:41] Speaker 00:
They noticed that some of the dependent claims referred to concentrations.

[00:28:46] Speaker 00:
And then they decided to use any argument they had as to low dose and try and fit it in the low concentration bucket.

[00:28:54] Speaker 00:
And that is not something that's possible.

[00:28:56] Speaker 00:
Because even if you knew the concentration, you wouldn't know what the dose was.

[00:29:01] Speaker 00:
You need additional information.

[00:29:03] Speaker 00:
And in particular, you need to know the overall amount of material or the weight of the tablet.

[00:29:10] Speaker 04:
Right.

[00:29:10] Speaker 04:
Can I just, I mean, if you wouldn't mind, think about appendix page 43, which is also page 43 of the board's opinion.

[00:29:17] Speaker 04:
And that's where the board is discussing the proposed amendments, proposed, yeah, amendments which would add claims 39, 40, and 54.

[00:29:26] Speaker 04:
And the board is there saying,

[00:29:30] Speaker 04:
Patent owners argue that these content limitations, which have to do with weight percents, and it uses the term that the patent owner argues that they were the first to discover that Fingalamod was difficult to formulate and had stability and content uniformity problems at low doses.

[00:29:51] Speaker 04:
And they cite to pages four and five of the motion to amend, which would have been filed, if I remember right, a week before the patent owner's response.

[00:29:59] Speaker 04:
I think it was.

[00:30:00] Speaker 00:
It's the same time they file their reply.

[00:30:03] Speaker 00:
It's concurrent with their reply.

[00:30:04] Speaker 04:
The motion to amend?

[00:30:05] Speaker 04:
Yes.

[00:30:06] Speaker 04:
Okay.

[00:30:06] Speaker 04:
So anyway, that's before the oral argument.

[00:30:09] Speaker 04:
Somebody is talking about low dose or at least the board is understanding somebody is having talked about low dose before the oral argument.

[00:30:16] Speaker 01:
And what about, just to add on here, page A, 2646, that's what I understand to be Novartis' expert's declaration, I think.

[00:30:28] Speaker 01:
In paragraph 18, they talk about changing proportions, not doses, but proportions, which I think is percentages.

[00:30:36] Speaker 01:
Has normally no effect on degradation except in the circumstances here.

[00:30:41] Speaker 01:
Well doesn't that talk about?

[00:30:43] Speaker 00:
percentages It does talk about percentages But you never heard about percentages below with the p-tab it was always the low dose and the difficulty with low doses Wasn't this document at a?

[00:30:58] Speaker 01:
2646 submitted as part of the record at the p-tab so what particular expert report?

[00:31:05] Speaker 01:
I believe that it was Novartis' expert.

[00:31:08] Speaker 05:
This is the Omura Declaration.

[00:31:10] Speaker 00:
Oh, Omura?

[00:31:11] Speaker 00:
Omura.

[00:31:12] Speaker 00:
Okay.

[00:31:12] Speaker 00:
Mr. Omura's declaration was found, frankly, not to be reliable by the PTAB below.

[00:31:20] Speaker 00:
And so they did consider it.

[00:31:22] Speaker 00:
They did look at it.

[00:31:23] Speaker 00:
But they did not weigh that as a big factor when they were balancing the evidence before them.

[00:31:29] Speaker 00:
Mr. Omura had

[00:31:33] Speaker 00:
The paragraphs plus at oral hearing with Mr. Omura, the tables that were focused on by Novartis were very different tables than what they'd like to bring to the board's attention now.

[00:31:45] Speaker 00:
They were very inconsistent with how they handled that.

[00:31:47] Speaker 00:
But both Mr. Omura, who's an inventor, and Mr. Poudapety, another inventor, both of their testimony was not found to be as reliable as some of the other evidence of record.

[00:31:59] Speaker 01:
Okay, thank you.

[00:32:00] Speaker 01:
I didn't mean to distract you from Judge Toronto's question, so he had other sites that he asked you.

[00:32:07] Speaker 00:
I do have the red light I just noticed, but I'm willing to entertain any other questions, should you have them?

[00:32:12] Speaker 04:
Yeah, let me just keep you for a moment.

[00:32:14] Speaker 04:
I just want to get these straight.

[00:32:17] Speaker 04:
So the motion to amend was filed April 3rd, 2015.

[00:32:20] Speaker 04:
I'm looking for, but I'm not finding immediately.

[00:32:25] Speaker 04:
I thought that the patent owner's response was filed.

[00:32:28] Speaker 04:
A week later, April 10th.

[00:32:31] Speaker 00:
I think that was, sorry, that was correct.

[00:32:33] Speaker 04:
So it wasn't actually at the reply stage.

[00:32:35] Speaker 00:
Yes, sorry.

[00:32:35] Speaker 04:
So this was almost immediately after.

[00:32:37] Speaker 04:
I mean, it was very early.

[00:32:39] Speaker 04:
And they expressly refer on page 7025 of the appendix, that's what's cited here, to low dose.

[00:32:49] Speaker 04:
It seems to me that that notion of low dose may be as a shorthand, or I'm not sure what,

[00:32:57] Speaker 04:
in referring to the concentrations was introduced in this proceeding well before the oral argument.

[00:33:07] Speaker 00:
Yes, that's correct.

[00:33:09] Speaker 05:
I guess I'm trying to figure out what is the character of the unexpected results argument that they actually presented to the board in the sense that were they really gunning for

[00:33:21] Speaker 05:
the claims that were directed to something with a low weight percentage in Golomod, or were they trying to make a different argument, which was, surprisingly there's stability issues for other excipients when we have a low dosage.

[00:33:39] Speaker 05:
For mannitol, it's stable.

[00:33:42] Speaker 05:
For Golomod, it's high percentage or low percentage, and so therefore we want

[00:33:48] Speaker 05:
in unexpected results finding based across the entire range.

[00:33:53] Speaker 05:
That's how I look at the argument section of their motion to amend, as well as the argument section of their patent owner response.

[00:34:02] Speaker 00:
I think that's correct, Your Honor, how I interpret it also.

[00:34:05] Speaker 00:
What's most relevant here is this entire discussion of low dose is irrelevant.

[00:34:12] Speaker 00:
Even during their motion to amend,

[00:34:14] Speaker 00:
They did not amend their claims to limit them to low dose.

[00:34:18] Speaker 00:
If you read the claim, claims 1 and 19, the independent claims in particular, they do the full range.

[00:34:24] Speaker 00:
They, high doses, medium doses, low doses, it's the entire range.

[00:34:29] Speaker 05:
What we're trying to figure out is the discussion and the fact section of these papers in reference to unexpected stability for low dose, which when it comes to Fingalamod, is that

[00:34:42] Speaker 05:
a dog whistle for all of us to recognize, we need to all run over to the dependent claims and look at the low weight concentration claims.

[00:34:50] Speaker 00:
No, Your Honor.

[00:34:51] Speaker 00:
So the low dose determination, the story behind it, so low dose to support that, they had Ms.

[00:34:57] Speaker 00:
Rains, R-A-N-E's declaration during prosecution.

[00:35:02] Speaker 00:
She had one dose, 0.25 milligram, and she was not made available for deposition.

[00:35:08] Speaker 00:
So therefore, the PTAB did not

[00:35:11] Speaker 00:
rely on that extensively in their determination.

[00:35:13] Speaker 04:
Just to be clear, what was the evidence that they offered in support of unexpected results for low dose?

[00:35:21] Speaker 04:
Was it actually, I understand perfectly logically the distinction between dose and concentration.

[00:35:28] Speaker 04:
You could have an extremely high dose at a very low concentration if the pill were this big, but the

[00:35:35] Speaker 04:
Was there evidence about dose or about concentration?

[00:35:38] Speaker 04:
Or were they just using dose essentially as a bad shorthand for low concentration?

[00:35:43] Speaker 00:
I think they used dose as low dose because what really started it all is they had comparisons.

[00:35:50] Speaker 00:
What really started it all was they used Fingolamid and they combined it with

[00:35:55] Speaker 00:
two ingredients that weren't necessarily compatible.

[00:35:59] Speaker 00:
So when they first did their stability studies, they had difficulty.

[00:36:02] Speaker 00:
They had carboxymethylstarch and another ingredient also with two other things.

[00:36:08] Speaker 00:
So when they first did their studies way back when, they had difficult times formulating it.

[00:36:13] Speaker 00:
So when they first decided, oh, we need a low dose Fingolamid.

[00:36:16] Speaker 00:
It's not going to be this high dose.

[00:36:18] Speaker 00:
They went ahead and they took the same poor starch additives, the carboxymethylstarch,

[00:36:24] Speaker 00:
and the other ingredient that was not found to be adequate.

[00:36:27] Speaker 00:
And they says, oh, we have stability issues here, because it's the same low dose.

[00:36:31] Speaker 00:
In the low dose, we have stability issues.

[00:36:33] Speaker 00:
And aha, mannitol is no problem.

[00:36:36] Speaker 00:
But when they tried that, those two ingredients that they used, the carboxymethyl starch and another ingredient, were the two that they already knew didn't work.

[00:36:46] Speaker 00:
So when they started formulating the low dose, they added two excipients that they already knew were not stable.

[00:36:54] Speaker 00:
that actually probably reacted with the Fingolamid.

[00:36:57] Speaker 00:
There was never any testimony on that per se.

[00:37:00] Speaker 00:
And then what they did is when they finally got smart and they said, you take the active ingredient and you do a binary combination, you try it against one excipient, guess which was the first excipient they chose?

[00:37:11] Speaker 00:
Manatol.

[00:37:11] Speaker 00:
And it didn't have either one of those two defective or problem excipients.

[00:37:17] Speaker 00:
And they had low dose and they says, aha, this is the magic.

[00:37:20] Speaker 00:
The real magic when they did the low-dose tablet is the fact that they didn't use those two other excipients that they were fully aware of didn't work.

[00:37:29] Speaker 01:
OK.

[00:37:30] Speaker 01:
Thank you.

[00:37:30] Speaker 01:
Can I ask you just one question about the Amora Declaration again?

[00:37:33] Speaker 01:
I thought that the board stated that it would not rely on certain paragraphs, but it denied the motion to exclude paragraphs 14 through 19.

[00:37:43] Speaker 01:
And the paragraph I was looking at was paragraph 18.

[00:37:46] Speaker 01:
So does that change your answer?

[00:37:50] Speaker 00:
So did they rely on, I know they, Novartis changed the focus and I don't remember is 18 the paragraph that they changed their mind and wanted you to rely on?

[00:38:00] Speaker 01:
Well, this is where he talks about changing proportions and to me it kind of went to the question of whether all the evidence was just talking about doses or was it talking about proportions or weight percentages.

[00:38:13] Speaker 01:
And so I'm just trying to understand, I thought that this evidence was presented

[00:38:19] Speaker 01:
to the PTAB and that the PTAB actually considered it and that it was other paragraphs of the Amora Declaration that weren't considered or given much weight by the PTAB.

[00:38:30] Speaker 00:
You know, Your Honor, I don't remember those tables and paragraphs that well, so I do apologize.

[00:38:36] Speaker 00:
So if you'd like further briefing on that or a letter, we would be pleased to provide it to the court.

[00:38:42] Speaker 00:
But Amora's wasn't, it's entirely up to you, Your Honor.

[00:38:46] Speaker 00:
But Amora's testimony overall was not weighed heavily from what we could determine in the board's determination.

[00:38:52] Speaker 00:
That's sufficient.

[00:38:53] Speaker 00:
Okay.

[00:38:53] Speaker 00:
Thank you so much.

[00:38:58] Speaker 04:
And eight minutes.

[00:39:02] Speaker 04:
Thank you, Your Honor.

[00:39:06] Speaker 03:
So starting with Sakai, and then I will certainly talk about the undetected.

[00:39:09] Speaker 04:
Can you start where at least my head is right now?

[00:39:11] Speaker 03:
Of course.

[00:39:12] Speaker 04:
Can you talk about what the evidence... I'm trying to figure out whether dose meant dose in the usage that it was being given in the supporting declarations and whatnot, or if it actually meant concentration.

[00:39:30] Speaker 03:
It meant concentration, and I can tell you why we use the word dose.

[00:39:33] Speaker 04:
Actually, I'm more interested in support for the proposition that it meant that by your pointing to a supporting declaration that makes it clear that's the way it was being used than why you did.

[00:39:44] Speaker 04:
Sure.

[00:39:44] Speaker 03:
I'll point to two things, Your Honor.

[00:39:47] Speaker 03:
The O'Mora Declaration, Mr. O'Mora was actually the inventor who figured out this little concentration problem.

[00:39:53] Speaker 04:
What page am I supposed to be looking at?

[00:39:55] Speaker 03:
I think it was paragraph 18 or 19.

[00:39:58] Speaker 04:
So appendix, I only have Jen.

[00:40:00] Speaker 04:
This is 2646.

[00:40:01] Speaker 05:
The sentence says, changing proportions normally has no effect on degradation except in circumstances not present here.

[00:40:14] Speaker 05:
Such circumstances can involve water-sensitive active ingredients and excipients that attract water to conditions not present in our formula.

[00:40:22] Speaker 03:
And then, very importantly, attached to Mr. Umura's declaration,

[00:40:27] Speaker 03:
were the charts showing his binary excipient testing results, which talked about varying the proportion of the excipients.

[00:40:38] Speaker 03:
And the reason we use the word dose... I'm sorry.

[00:40:42] Speaker 05:
For me, the sentences I just read don't equate low weight percentage with low dosage.

[00:40:51] Speaker 05:
Is there something in the record where I can feel like

[00:40:56] Speaker 05:
I understand that someone else understood that these two terms are basically interchangeable.

[00:41:01] Speaker 05:
Yes, your honor.

[00:41:03] Speaker 03:
First off, in our patent owner's response, at appendix number 7530, so that was our brief, the first brief we filed, we do talk about how the parallels between the dependent claims we were talking about.

[00:41:19] Speaker 03:
I'm sorry, 7530.

[00:41:20] Speaker 03:
7530.

[00:41:21] Speaker 02:
I can't be right.

[00:41:23] Speaker 02:
I think that's our patent owner's response.

[00:41:25] Speaker 02:
I got the wrong one.

[00:41:26] Speaker 02:
No such page between here.

[00:41:27] Speaker 03:
You got something different.

[00:41:29] Speaker 03:
OK, so then that must be from the record below, and it must have been omitted in the record.

[00:41:33] Speaker 04:
No, it may be here.

[00:41:34] Speaker 04:
You just may have the wrong page.

[00:41:36] Speaker 03:
OK.

[00:41:36] Speaker 03:
Well, I can find the page.

[00:41:38] Speaker 03:
I do know, because I wrote it, that there was a paragraph in the discussion of the claims, the specification of the claims, in which we drew an explicit parallel.

[00:41:49] Speaker 01:
How about 7-3-5-0?

[00:41:50] Speaker 01:
There you go.

[00:41:51] Speaker 03:
The dyslexia struck.

[00:41:52] Speaker 03:
Sorry about that.

[00:41:55] Speaker 03:
7-3-5-0.

[00:41:59] Speaker 03:
Where we've drawn it's just parallel between the concentration and the dependent claims and the discovery.

[00:42:07] Speaker 05:
The underlying evidence to that is the- OK, it's not 7-3-5-0, but keep going.

[00:42:12] Speaker 03:
OK, if it is, we can find it for you.

[00:42:17] Speaker 03:
But the underlying evidence for that is in the Ulmer Declaration, where he talks about how the problem they discovered.

[00:42:24] Speaker 03:
He goes through in great detail that the problem they discovered was they started with a high dose formulation.

[00:42:33] Speaker 03:
Then the preclinical and the clinical folks came back to them and said, we need to lower the dose because we're having some issues.

[00:42:40] Speaker 03:
And the formulator said, OK, no problem.

[00:42:41] Speaker 03:
And they tried to simply just

[00:42:43] Speaker 03:
lower the amount in proportion to the excipients.

[00:42:46] Speaker 03:
Lower the active ingredient, fungalamide, in proportion to the excipients.

[00:42:49] Speaker 03:
And that's when they discovered, all of a sudden, there's this very strange instability group of problems at that moment.

[00:42:56] Speaker 03:
And they tried to solve it, as formulators do, by adding stuff into the mix to try to stabilize it.

[00:43:01] Speaker 03:
And that didn't work.

[00:43:03] Speaker 04:
So where are these attachments, if we can look at them?

[00:43:11] Speaker 03:
We're putting our hands on them, Your Honor.

[00:43:15] Speaker 04:
Because I guess in just looking at the page that we were discussing before, the paragraph 18 page, the 2646, there are several tables here, table two, table five and six.

[00:43:28] Speaker 04:
I'm not seeing, so maybe you can help me see if it's there, that these tables are discussing something about the relative concentration of the active ingredient and the other stuff, or they're just

[00:43:45] Speaker 04:
discussing one milligram, five milligrams, et cetera.

[00:43:57] Speaker 04:
It's kind of a surprising conflation to use the term dose to talk about concentration.

[00:44:04] Speaker 04:
Well, unless all pills are of a fixed size and the dose is only the active ingredient, and then one translates it to the other.

[00:44:11] Speaker 03:
The reason that that language crept in, Your Honor, is because of the source of the problem.

[00:44:17] Speaker 03:
The original source of the problem was that they had a high-dose formula that had, I think, five milligrams of van Gogh on it, something like that.

[00:44:24] Speaker 03:
And the clinical researchers came back to the formulators and said, we need a lower dose.

[00:44:30] Speaker 03:
And that was the starting point.

[00:44:32] Speaker 03:
And so what the formulators did is they took that amount to Fingalimod, and all they did is just lower, keeping it within the same excipient matrix.

[00:44:40] Speaker 03:
And then they discovered, oh my goodness, it's breaking apart.

[00:44:43] Speaker 04:
Why?

[00:44:43] Speaker 04:
So where is the part of the record that says keeping the amount of excipient that we had when we had, I don't know, five milligrams or whatever, the higher amount of the?

[00:44:55] Speaker 03:
It is in the Ulmer Declaration.

[00:45:10] Speaker 03:
Okay, so starting on paragraph 10 of the Omer Declaration, which is 10, which is appendix 2643.

[00:45:16] Speaker 02:
Was that excluded?

[00:45:18] Speaker 02:
Pardon me?

[00:45:18] Speaker 02:
Was that paragraph excluded?

[00:45:20] Speaker 02:
I don't recall if it was excluded.

[00:45:21] Speaker 01:
I think it was excluded.

[00:45:22] Speaker 01:
It was certainly excluded.

[00:45:24] Speaker 01:
The board stated that it didn't rely on it.

[00:45:25] Speaker 01:
It was certainly excluded.

[00:45:25] Speaker 02:
It didn't rely.

[00:45:26] Speaker 03:
I think you have an appeal.

[00:45:27] Speaker 03:
It was excluded.

[00:45:29] Speaker 03:
It talks about the initial tests in one to five ratios.

[00:45:35] Speaker 03:
Okay, and then it shows you in that, you see that chart there?

[00:45:39] Speaker 03:
And it's got white lines, and the white lines are instances in which vandalimod was stable with an excipient or deemed stable.

[00:45:46] Speaker 03:
And then the gray lines are instances in which it was not.

[00:45:54] Speaker 01:
OK.

[00:45:54] Speaker 01:
And so you also said earlier that your patented response explained how dose really means weight percentage or includes it or something.

[00:46:04] Speaker 01:
But I don't see that.

[00:46:05] Speaker 01:
in your patent owner's response.

[00:46:09] Speaker 01:
Could you give us a... Yes, Your Honor.

[00:46:10] Speaker 03:
Yes.

[00:46:11] Speaker 03:
What the patent owner's response did... Let me grab it here.

[00:46:17] Speaker 03:
What the patent owner's response did is it drew an express parallel between the low concentration dependent claims that we've been discussing and the results that

[00:46:31] Speaker 03:
the inventors found when they tried to vary the proportion of engolamod in the mix.

[00:46:38] Speaker 03:
So.

[00:46:46] Speaker 03:
That is.

[00:46:55] Speaker 03:
Okay, so page, that's 7330.

[00:46:57] Speaker 03:
That's why.

[00:46:59] Speaker 03:
7330.

[00:46:59] Speaker 03:
7330.

[00:47:00] Speaker 03:
My bad handwriting.

[00:47:01] Speaker 03:
Apologies for the poor.

[00:47:03] Speaker 03:
7330.

[00:47:06] Speaker 03:
It calls out how those weight claims are all about the low-dose issue.

[00:47:13] Speaker 03:
You see the first and second at the bottom there?

[00:47:16] Speaker 03:
First, claim one, and then it talks about that's the independent claim.

[00:47:19] Speaker 03:
where it calls out some of the dependent claims.

[00:47:22] Speaker 01:
But I don't see where it uses the word dose.

[00:47:26] Speaker 02:
It does in the second where it says... Well, also in first.

[00:47:30] Speaker 04:
These include claim aid, including the S1P receptor of 0.5 to 5% of the composition, a low dose range.

[00:47:36] Speaker 04:
And then again in second, claim 23, limiting the mixture to 90 to 99.5% mannitol, a low dose formula.

[00:47:44] Speaker 04:
That does, in

[00:47:46] Speaker 04:
Am I reading that right?

[00:47:47] Speaker 04:
Seem to be equating dose with concentration.

[00:47:49] Speaker 03:
Exactly right.

[00:47:50] Speaker 03:
And then the charts that we relied on in the Ormore Declaration show the evolution of this understanding by the inventors, where they started at 1 to 5, and it was stable with a lot of recipients.

[00:48:01] Speaker 03:
And then they moved, and as they went down from 1 to 10, they started seeing increasing instability, which was surprising.

[00:48:07] Speaker 03:
That is the unexpected.

[00:48:08] Speaker 05:
What I'm wondering is, why my understanding of your patent owner response for motion to amend

[00:48:15] Speaker 05:
and you're referencing to low dosages, all those arguments are directed to independent claim 19 or the corresponding amended independent claim in your motion to amend.

[00:48:30] Speaker 05:
These arguments aren't directing the board to consider this type of unexpected results with the actual dependent claims that recite the particular low weight percentages.

[00:48:43] Speaker 05:
That's correct honor what we did is Focus on specifically claim 19 is really the focus of most of the proceeding that was that was the independent claim And so then as I understand your unexpected results argument for claim 19 that you presented to the in your patent owner response It was making an argument that What was unexpected is that?

[00:49:07] Speaker 05:
is stable across the full dosage range.

[00:49:12] Speaker 05:
And then the board came back and said, okay, you're making this argument about claim 19, which is really kind of a low dosage argument.

[00:49:20] Speaker 05:
And the problem with the low dosage argument for claim 19 is it's not commensurate with the full scope of claim 19.

[00:49:27] Speaker 05:
So we can't really give it probative weight.

[00:49:33] Speaker 05:
But then the next question is, well,

[00:49:35] Speaker 05:
It doesn't appear that you made any kind of corresponding argument with the dependent claims in trying to match your unexpected results evidence to those particular claims.

[00:49:47] Speaker 03:
Right.

[00:49:47] Speaker 03:
Our problem here is that we, as in the page of the Patent Honor Response, we were just going over.

[00:49:51] Speaker 03:
We called out this relationship between the low concentration instability problem and those dependent claims.

[00:50:00] Speaker 03:
Our arguments definitely focused on the arguments that the petitioner focused on, which was all about claim 19.

[00:50:04] Speaker 03:
And that is what we focused on.

[00:50:07] Speaker 03:
And the motion to amend, we had more specific argumentation about the amended claims that are parallel to these claims.

[00:50:14] Speaker 03:
And at the oral argument, there was some discussion of this as well.

[00:50:17] Speaker 05:
But when I look at the motion to amend, it's basically the same sentence in the argument for unexpected results.

[00:50:24] Speaker 05:
Manitou unexpectedly is stable with Fangalama

[00:50:27] Speaker 05:
throughout the full dosage range.

[00:50:28] Speaker 05:
So it's really the same argument.

[00:50:30] Speaker 05:
It's the identical sentence in both the patent owner response and the motion to amend.

[00:50:35] Speaker 03:
Right.

[00:50:35] Speaker 03:
But of course, the dosage range for the low concentration claims would be a lower dose than for the independent claim.

[00:50:41] Speaker 03:
But the key problem that we had with what the board did was that it accepted for purposes of its final written decision the premise that we had made a discovery about low concentration instability of this odd molecule.

[00:50:53] Speaker 03:
And then it went on.

[00:50:55] Speaker 05:
Where did the board say that?

[00:50:56] Speaker 05:
I mean, I know you quoted it twice, but it's actually a little bit misleading of a quote.

[00:51:03] Speaker 03:
No, Your Honor.

[00:51:04] Speaker 05:
I mean, you quoted, despite agreeing, quote, the stability of the mannitol-fingolamide combination at low doses was unexpected, see A22.

[00:51:15] Speaker 05:
The board found these results not commensurate.

[00:51:17] Speaker 05:
But then when you go look at A22, the board says, even if,

[00:51:22] Speaker 05:
and then your quoted language, the stability of mannitol, fengolamide, combination of low doses was not expected, it's nevertheless legally insufficient because it doesn't go across the full range of claim 19.

[00:51:33] Speaker 05:
And what I believe the board did is it assumed... So do you still believe that the board agreed with you?

[00:51:39] Speaker 05:
I believe that... That the stability of the mannitol, fengolamide, combination of low doses was unexpected?

[00:51:44] Speaker 03:
I believe that the board accepted that premise for... When it says even if...

[00:51:48] Speaker 03:
I believe that it accepted the premise for purposes of its analysis in its final written decision without ever actually making a final factual determination on the question.

[00:51:56] Speaker 05:
So it didn't agree with you?

[00:51:57] Speaker 03:
Well, it agreed with the premise.

[00:51:59] Speaker 03:
It didn't actually make a final final.

[00:52:01] Speaker 03:
And then it carried.

[00:52:02] Speaker 03:
And then the problem is that having accepted the premise.

[00:52:05] Speaker 05:
You want to double down.

[00:52:06] Speaker 03:
That's fine.

[00:52:06] Speaker 03:
Your Honor, even if you could use the word arguendo if you like as well, it accepted that premise and then did its analysis based on that premise.

[00:52:14] Speaker 03:
Put differently, it didn't reject the premise.

[00:52:17] Speaker 03:
And that is what we mean.

[00:52:19] Speaker 03:
It did not need to address the premise.

[00:52:22] Speaker 03:
Right.

[00:52:22] Speaker 03:
Because it felt that there was a commensurability problem.

[00:52:24] Speaker 03:
That's exactly right.

[00:52:26] Speaker 03:
And our point is that there, with respect to these dependent claims, there is no commensurability problem.

[00:52:31] Speaker 03:
They're perfectly commensurate.

[00:52:33] Speaker 03:
And when the board counts... But you didn't argue the dependent claims with the unexpected results.

[00:52:37] Speaker 03:
That's the issue.

[00:52:38] Speaker 03:
Well, I understand that, Your Honor.

[00:52:39] Speaker 03:
And the question is whether we should have or not.

[00:52:42] Speaker 03:
And we didn't have any reason to think that the board wouldn't carry forward reasoning

[00:52:45] Speaker 03:
from one claim to the next.

[00:52:46] Speaker 03:
The board goes on in its written decision and talks about each claim separately, one at a time, or in small groups.

[00:52:52] Speaker 03:
And when it gets to these dependent claims, it doesn't carry forward the reasoning about commensurability that it had used with respect to claim 1980.

[00:52:59] Speaker 05:
Because you admitted you were devoting those arguments to claim 1980 along a full dosage range type of a theory.

[00:53:06] Speaker 03:
There's no question, Your Honor, we were certainly focused on that.

[00:53:08] Speaker 03:
But we also drew the board's attention to this alternative point, which is that the dependent claims are

[00:53:15] Speaker 03:
low concentration claims.

[00:53:17] Speaker 03:
And they go parallel to the discovery.

[00:53:20] Speaker 04:
I think I'm about to call this to an end.

[00:53:23] Speaker 03:
Do you have a sentence?

[00:53:24] Speaker 03:
Understood, Your Honor.

[00:53:25] Speaker 03:
If I may just have one brief summary on Sakai, because there were a couple of representations made that I'd like to address.

[00:53:32] Speaker 03:
One was that we did not move to exclude Sakai.

[00:53:34] Speaker 03:
That's actually not true.

[00:53:35] Speaker 03:
On page 20 of our motion to exclude, we did move to exclude Sakai under rules 402 and 403 for reasons that are a mystery to me.

[00:53:43] Speaker 03:
That one page of the motion to exclude did not make it into the joint appendix that went to the court.

[00:53:47] Speaker 03:
But it is in the record below.

[00:53:49] Speaker 03:
And I encourage your honors to look at it.

[00:53:51] Speaker 03:
And lastly, I just want to circle back to your question about district court proceedings and law of the case in district court proceedings and how that works.

[00:54:01] Speaker 03:
It depends on the type of proceedings.

[00:54:02] Speaker 03:
A preliminary injunction is one thing.

[00:54:04] Speaker 03:
A finding on a motion to dismiss or a finding on partial summary judgment motion or a partial trial, it depends on the context.

[00:54:12] Speaker 03:
And here, the context was they made a finding that formed the basis of them excluding the Sakai-based grounds from the case.

[00:54:20] Speaker 03:
And in that context, we say we're entitled to rely.

[00:54:23] Speaker 04:
Thank you very much.

[00:54:24] Speaker 04:
Thanks to all counsel.

[00:54:25] Speaker 04:
The case is submitted.