[00:00:00] Speaker 02:
We will hear argument next in number 22, 2276, Sumitomo Pharma against Vidal.

[00:00:08] Speaker 02:
Mr. Saunders, can you just begin by telling, do I understand right, this patent expired a couple of weeks ago?

[00:00:15] Speaker 03:
Yes, the patent expired on February 20th.

[00:00:17] Speaker 02:
And so what's at stake?

[00:00:20] Speaker 03:
There's a difficult question I've been thinking about.

[00:00:23] Speaker 03:
There is still a look back period for damages.

[00:00:28] Speaker 03:
Obviously, in candor of the court, it's a highly regulated entry.

[00:00:32] Speaker 03:
It's a highly regulated entry.

[00:00:34] Speaker 02:
Are there generics that have actually entered?

[00:00:36] Speaker 03:
There are generics who have entered the market pursuant to settlement agreements.

[00:00:42] Speaker 03:
So what would be at stake here is whether there has been unauthorized use.

[00:00:46] Speaker 03:
I can't stand before you and presently say we are aware that it's happened in the last six years.

[00:00:54] Speaker 03:
Is that a problem for our jurisdiction?

[00:00:59] Speaker 03:
I think that in general, when you're within the six year look back period, the court has- But in this industry, they couldn't have entered, right?

[00:01:07] Speaker 03:
Right.

[00:01:07] Speaker 03:
In this industry, then it may be that the proper course here is a monty-wear figure, which is if this has become moot,

[00:01:16] Speaker 03:
through actions beyond the control of the parties, then the solution is not to leave this opinion on the books, but to say we've lost jurisdiction during the course of the appeal here and the opinion and the problematic reasoning, which we're worried about would be vacated due to mootness.

[00:01:36] Speaker 03:
Okay.

[00:01:37] Speaker 03:
On the merits.

[00:01:38] Speaker 03:
On the merits, I'd like to start by highlighting three of the many errors of law.

[00:01:44] Speaker 03:
that the board made in addressing our groundbreaking treatment claims.

[00:01:48] Speaker 03:
First, the board incorrectly held that safety was irrelevant to obviousness unless it was expressly claimed.

[00:01:56] Speaker 03:
And the board thus refused to consider the prior art's concern with the serious risk of sudden cardiac death, a concern that was so acute that our own sophisticated partner abandoned the project due to that risk.

[00:02:12] Speaker 03:
Second, the board misapplied the law of inherency, both in applying it prematurely and in misapplying the patient claim in an internally inconsistent way, switching focus midway through between a patient population and this theory of an individual outlier patient, even though they should be treated consistently within the claim.

[00:02:36] Speaker 03:
And then the third main error I want to highlight is the board shifted the burden of persuasion when it was discussing the Horisawa reference, and that's an issue on which the director hasn't even responded at all.

[00:02:50] Speaker 02:
Can you remind me of that last point?

[00:02:52] Speaker 02:
Horisawa is the one that says this compound

[00:02:59] Speaker 02:
seems to act on particular receptors.

[00:03:02] Speaker 02:
And so there's a suggestion that it will have a weak weight gain effect.

[00:03:07] Speaker 02:
Right.

[00:03:07] Speaker 03:
There's a suggestion there.

[00:03:08] Speaker 03:
And so that analysis that the board does, on the front end, it's entered into a burden shifting framework because of the overlapping ranges it saw in the SAGI reference.

[00:03:20] Speaker 03:
But this court made clear in its DuPont case that within that framework, the burden of persuasion always remains on the challenger.

[00:03:29] Speaker 03:
But the board framed that analysis at the beginning in terms of us not overcoming that or not showing through our evidence and argument that was incorrect.

[00:03:42] Speaker 03:
And then you also see this in the way it discussed Horisawa because rather than reaching a firm conclusion,

[00:03:48] Speaker 03:
on Horisawa, that's the passage where it ends simply by concluding that a person of skill wouldn't disregard the reference.

[00:03:56] Speaker 03:
But that's not really the question that is supposed to be before the board.

[00:04:00] Speaker 03:
It's in light of that speculative statement in Horisawa lined up against the counter evidence that we came forward to showing there's no consistent relationship here between these binding profiles and the general class of atypicals.

[00:04:16] Speaker 03:
Yes, yes, in the general class.

[00:04:18] Speaker 03:
You can look at those same receptors and see, and we have the chart here, it's page 19 of the blue brief, which shows that some things that have strong binding affinity, some other compounds that have weak binding affinity, some that have very similar profiles, one will have what gain, one won't.

[00:04:37] Speaker 03:
So we come forward with all that.

[00:04:39] Speaker 03:
And what the board does is really misapplying the Beckman line of cases, just says, well, Horosawa wouldn't be disregarded.

[00:04:46] Speaker 03:
It's thinking in the terms of, you know, if a reference isn't working for its stated purpose, it may still have a valid teaching in there.

[00:04:55] Speaker 03:
But the question at that point was not one of, would you disregard Horisawa?

[00:04:59] Speaker 03:
It's, is a person of ordinary scale going to have a reasonable expectation of success based on its speculation when there's so much uncertainty in the art and we've come forward with all of this other.

[00:05:11] Speaker 02:
And what is the success of which there must be a reasonable expectation?

[00:05:16] Speaker 03:
It is the claimed success here.

[00:05:19] Speaker 03:
So in that case, the focus was on the weight gain.

[00:05:24] Speaker 03:
And more generally, the reason I began with the safety concern is because it was a mistake for the board to say we're going to completely disregard the safety concern unless it's expressly claimed.

[00:05:40] Speaker 03:
All the time in this industry, safety is always a concern.

[00:05:44] Speaker 03:
Last year in this course, M. Janvis Sando's case, we cited there was no express claim element going to safety, but the fact that there was structural similarity to thalidomide was a very relevant fact in the prior art in terms of shaping the decisions that we made.

[00:06:03] Speaker 03:
Even outside this context, we cited the Arctic Cat case, where with the new throttle system on the jet skis there.

[00:06:10] Speaker 03:
Again, there's no specific claim element saying, and this produces a safe jet ski, but the prior concerns of, well, is this new throttle mechanism going to be safe?

[00:06:20] Speaker 01:
One argument that you were making in your briefing was with respect to potentially an inconsistent application of the word patient.

[00:06:27] Speaker 03:
Yes.

[00:06:28] Speaker 01:
Does that interplay in your kind of three points, or is that a separate

[00:06:32] Speaker 03:
So the safety point cuts across everything.

[00:06:36] Speaker 03:
And no point in its analysis does the board consider that.

[00:06:39] Speaker 03:
It tells us exactly why it's not, because it says this is legally irrelevant if not claimed.

[00:06:44] Speaker 03:
That is a mistake of law.

[00:06:46] Speaker 03:
That alone requires remand.

[00:06:48] Speaker 03:
Then in the board's analysis, it gets very confusing, quite frankly, as to when it's invoking inherency and when it's talking about reasonable expectation of success.

[00:07:00] Speaker 03:
And so on the inherency prong, the two issues that we are raising in that context are the order in which the evidence is being considered.

[00:07:09] Speaker 03:
In other words, rather than considering all the evidence to determine what selections and modifications would be made and only then applying inherency, the board considers some of the evidence, then reaches a conclusion of inherency to disregard the rest.

[00:07:24] Speaker 03:
And then that's where we get into the patient as well, because within the inherency analysis,

[00:07:29] Speaker 03:
What the board's essentially saying is, if you look at administering this to a big population of patients, then you're inherently going to find some outlier who wouldn't gain weight.

[00:07:44] Speaker 03:
Because it wasn't basing this, a very unusual inherency analysis.

[00:07:47] Speaker 03:
It wasn't trying to base it in actual data.

[00:07:49] Speaker 03:
It had this outlier theory.

[00:07:51] Speaker 03:
And in doing that, it's essentially starting the claim by reading the patient who's administered in terms of a patient population, and it's finishing the claim by reading the patient who's administered in terms of the individual patient.

[00:08:07] Speaker 03:
That's the only way the outlier theory works, is you find that outlier amid a big population.

[00:08:16] Speaker 03:
I understand the opinion to be given in the inherency context, but whether it's inherency or reasonable expectation of success, that's a big problem.

[00:08:23] Speaker 03:
That's switched midway through the claim.

[00:08:25] Speaker 03:
We're not disputing the basic starting premise of patient could be one or more, but within the claim, there has to be internal consistency.

[00:08:35] Speaker 03:
So this is like this court's opinion in Salazar, the AT&T, where it said a microprocessor and it had to perform certain functions.

[00:08:43] Speaker 03:
So it could be one or more.

[00:08:45] Speaker 03:
But you couldn't be switching and looking at those functions and saying, well, this processor performs that one, and this processor performs that one.

[00:08:52] Speaker 02:
I'm not sure if this is a coherent question.

[00:08:54] Speaker 02:
Can you state affirmatively what a non-switching line of reasoning would have looked like here?

[00:09:00] Speaker 03:
A non-switching line of reasoning would say, I'm either going to focus on an individual patient and think of any patient sort of picked at random.

[00:09:09] Speaker 03:
I administer the drug to that person.

[00:09:11] Speaker 03:
Is that person going to gain weight?

[00:09:15] Speaker 03:
And whether that is an inherency analysis, there's no reason to think that any individual patient, or you would have to look at a patient population as a whole and do the analysis of say, if I administer to that patient population, then what do I expect?

[00:09:34] Speaker 03:
about that population.

[00:09:35] Speaker 03:
And the board never did that analysis.

[00:09:37] Speaker 03:
Because it switched midway through and went to this outlier theory.

[00:09:41] Speaker 02:
Well, would there be a legitimate way of looking at it that says the question is whether a relevant skilled artisan would have been motivated to perform the claims specified steps using the racidone?

[00:09:55] Speaker 02:
Is that what it's called?

[00:09:56] Speaker 02:
Yes.

[00:09:56] Speaker 02:
The racidone in the 20 to 120 milligram once a day regimen on

[00:10:04] Speaker 02:
a large enough pool of patients, whatever that number is, to have a reasonable expectation of success in producing the claim specified effect of no clinically significant weight gain in one.

[00:10:17] Speaker 03:
Well, before you can get to that point, Your Honor, that you have to think about the initial motivation

[00:10:26] Speaker 02:
Right.

[00:10:26] Speaker 02:
I'm building in that you would need a motivation to do the steps.

[00:10:35] Speaker 02:
I'm separating the steps from the property that follows when you do the steps.

[00:10:42] Speaker 02:
So there would be things that would go into that, into the motivation.

[00:10:46] Speaker 02:
You say, I think, why would, when you're reading sagis, why would you select the racidone among lots of other possibilities?

[00:10:55] Speaker 02:
You say, why would you, you know, select more than a hundred milligrams, not select, but go to more than a hundred milligrams.

[00:11:03] Speaker 02:
Why would you do once a day?

[00:11:05] Speaker 02:
I'm going to put aside the once a day.

[00:11:07] Speaker 02:
And then a reasonable expectation of success would depend on some knowledge of

[00:11:16] Speaker 02:
How unlikely this is and maybe whether it would be worthwhile if the probability was sufficiently low.

[00:11:25] Speaker 02:
You wouldn't do that.

[00:11:27] Speaker 02:
I'm trying to understand how, how this is supposed to work.

[00:11:31] Speaker 03:
Right.

[00:11:31] Speaker 03:
I think that that is with all the premises you're honestly, I think that is the analysis that would have to be done in terms of thinking of that population.

[00:11:40] Speaker 03:
It's not anything the board did.

[00:11:42] Speaker 03:
We're not asking this court to do it.

[00:11:43] Speaker 03:
It's something that the board should be doing.

[00:11:46] Speaker 03:
on remand.

[00:11:48] Speaker 03:
In terms of the expectations here, what we know from the background expectations is this is a class of drugs, the atypical antipsychotic, that is plagued by weight gain problems.

[00:12:01] Speaker 03:
And the one drug that is overcoming that, Zipracidone, is the one that has the risk of sudden cardiac death.

[00:12:09] Speaker 03:
And the petitioner's theory here, and sort of framing this for the board, was to try to do this analogy to Zipracidone

[00:12:15] Speaker 03:
and say, well, that would be structurally similar.

[00:12:18] Speaker 03:
And so in terms of the background expectations here, really it is an expectation of weight gain with the one potential exception being a drug that then creates this expectation of quite frankly, an even worse problem that the board was failing to consider.

[00:12:37] Speaker 02:
What's a good precedent from your point of view about needing a reason to pick out

[00:12:45] Speaker 02:
loracidone in SAGI, even though from SAGI is a larger pool of subject compounds.

[00:12:55] Speaker 03:
Well, I think it follows just in general, I'm not sure a particular case is coming to mind.

[00:13:02] Speaker 03:
It follows in general from the principle that SAGI is, as we've described, it's sort of a pick and choose disclosure.

[00:13:07] Speaker 03:
It's such a large, we're talking about a genus of more than a million compounds, all of these different ranges.

[00:13:13] Speaker 03:
Remember, even at the end of SAGI, the petitioner's own theory was going to dose ranging studies at the end of that because even within the range that's been focused on on the dose, that doesn't cover some individually claimed doses like the 120 milligram dose is out of it.

[00:13:32] Speaker 03:
So this wasn't presented as an anticipation theory because it was recognized that

[00:13:39] Speaker 03:
Saji has these disclosures.

[00:13:41] Speaker 03:
It really is a claim directed to the composition.

[00:13:44] Speaker 03:
And so all these pieces would have to be pieced together.

[00:13:47] Speaker 02:
Right.

[00:13:47] Speaker 02:
I guess I'm just wondering whether, and I just don't remember whether this was in the board or in the director's brief, a kind of, let's just start with the fact that Saji discloses the racetone.

[00:14:01] Speaker 02:
Now we can talk about everything else, but we get to start with that.

[00:14:06] Speaker 02:
And I thought at least one of your points was you don't get to start with that.

[00:14:11] Speaker 02:
You need to have a motivation to start with that.

[00:14:14] Speaker 02:
I'm trying to understand how to think about it.

[00:14:16] Speaker 03:
I think the way to think about it is it's such a large genus.

[00:14:20] Speaker 03:
And so decisions have to be made as sort of which of these compounds, even within SAGI, are you going to.

[00:14:27] Speaker 03:
And we've ended up with a theory that takes us to the compound that has structural similarities to Ziprasidone.

[00:14:33] Speaker 03:
And then we've pointed out the alternatives to SAGI and the sort of long list of alternatives and long, because that's going to be in the background, the back of the mind of a person of ordinary skill is, well, am I really going to go down this course?

[00:14:49] Speaker 03:
Remember when we talk about performing dose ranging studies,

[00:14:52] Speaker 03:
or things like testing for half life, we're talking about testing these drugs in humans.

[00:14:56] Speaker 03:
So am I gonna go down this course with this drug that comes with all this baggage when I have alternatives to loracidone within SAGI and many, many more alternatives outside of SAGI as well.

[00:15:12] Speaker 03:
And it plugs into an incredibly unpredictable art.

[00:15:15] Speaker 03:
And for there, I think the Honeywell case we've cited is the best one in terms of criticizing

[00:15:22] Speaker 03:
the board for applying inherency before it considered that unpredictability in the art, which would go to the initial selections and combinations that might bear on whether inherency is applied.

[00:15:34] Speaker 01:
A few clarifying questions.

[00:15:35] Speaker 01:
Okay.

[00:15:36] Speaker 01:
Are you arguing that the board's analysis of the objective indicia of ibisys was insufficient?

[00:15:43] Speaker 01:
It was a little unclear.

[00:15:44] Speaker 01:
Like sometimes I thought you might've been taking some

[00:15:48] Speaker 03:
Yes.

[00:15:49] Speaker 03:
And for two reasons.

[00:15:51] Speaker 03:
One, on the skepticism objective addition.

[00:15:54] Speaker 03:
That's the withdrawal of the commercial partner.

[00:15:56] Speaker 03:
The board just says we refuse to consider this if it's not claimed.

[00:16:00] Speaker 03:
And then the other thing was by the time it reaches and analyzes the objective addition, it basically discounts them based on its inherency finding on weight

[00:16:11] Speaker 03:
So it's saying, well yes, you have all these amazing things that have come with this compound, commercial success, it meets a long felt need, but because we found the weight gain inherent, that overrides it.

[00:16:24] Speaker 03:
And the objective indicia and some very similar evidence going to the unpredictability needed to be considered upfront before you could get to that sort of operative combination of steps that would output the inherency finding.

[00:16:36] Speaker 03:
So it's really a question of because it considers it in the wrong order,

[00:16:41] Speaker 03:
It doesn't give it the complete and correct consideration that it should.

[00:16:45] Speaker 01:
And then also, are you arguing that the board's motivation to modify analysis for the dosing range was insufficient anyway?

[00:16:52] Speaker 03:
Well, it was because it didn't consider that unpredictability in the art and the concerns about weight gain.

[00:17:00] Speaker 03:
Remember, by the time we're talking about here, there are already eight compounds on the market.

[00:17:07] Speaker 03:
Real focus is not just can I get something effective?

[00:17:11] Speaker 03:
It's that combination, the sweet spot that was hit here in terms of can I get something effective that avoids the weight gain, because weight gain leads to all sorts of direct medical problems and compliance problems as well.

[00:17:24] Speaker 03:
And the board doesn't, in thinking about that path and all the selections and modifications for fluorescent, it doesn't think about how weight gain or safety factor in there.

[00:17:34] Speaker 03:
Instead, it reaches that conclusion

[00:17:36] Speaker 03:
then uses its own inherency finding coming out of that to disregard the weight gain.

[00:17:40] Speaker 03:
So it's considering it at the wrong part of the analysis.

[00:17:44] Speaker 01:
And then I just want to give you maybe a few seconds, because I know we're over.

[00:17:49] Speaker 01:
Sure.

[00:17:49] Speaker 01:
In specific, you talk about, I don't know if I'm saying it correctly, the Horosawa reference and this weak effect on weight gain.

[00:17:56] Speaker 03:
Right.

[00:17:56] Speaker 03:
So the Horosawa, it has this sort of speculative statement based on this very early in vitro testing.

[00:18:05] Speaker 03:
We came forward with evidence saying, well, look, it's highlighting certain receptor profiles, but olanzapine and suppressinone, they have similar binding on that profile, but wildly diversion effects on waking.

[00:18:17] Speaker 03:
We sort of came forward with all the unpredictability evidence.

[00:18:21] Speaker 03:
And we're not asking this court to reweigh the facts on Horisawa.

[00:18:25] Speaker 03:
We were saying, we want you to sort of police the legal framework that the board was using.

[00:18:30] Speaker 03:
And at the beginning of the analysis, it is saying that

[00:18:35] Speaker 03:
It finds our evidence and argument insufficient to rebut the presumption of obviousness.

[00:18:40] Speaker 03:
So it's improperly placing the burden of persuasion on us, even though it's court held in the DuPont case, that that doesn't shift.

[00:18:47] Speaker 03:
And then at the end of the Horisawa analysis, it's that indeterminate conclusion, just saying, well, you wouldn't, it notes our evidence and says, well, someone wouldn't disregard Horisawa.

[00:18:57] Speaker 03:
And as I said earlier, that's not the question.

[00:18:59] Speaker 03:
It's when you put them all together,

[00:19:02] Speaker 03:
Lesson is the person of ordinary skill going to draw from the art as a whole.

[00:19:08] Speaker 02:
Thank you.

[00:19:17] Speaker 00:
Good morning, Your Honors.

[00:19:18] Speaker 00:
May it please the Court?

[00:19:19] Speaker 00:
I'd like to address several things.

[00:19:22] Speaker 00:
Questions the Court asked and the answers provided by my friend across the aisle.

[00:19:28] Speaker 00:
The first is Judge Toronto's question regarding, well, why would one of ordinary scale in the art pick loracidone from SAGI?

[00:19:39] Speaker 00:
It's not whether one of ordinary scale in the art would pick loracidone from SAGI.

[00:19:43] Speaker 00:
As the board notes in its decision, SAGI picked from that large sheet of six compounds to be lead compounds.

[00:19:52] Speaker 00:
Loracidone is

[00:19:53] Speaker 00:
number one-on-one of those compounds, and SAGI claimed only six of those compounds, one of which was loracidone and claimed 14.

[00:20:02] Speaker 00:
And so one of ordinary skill in the art wouldn't go through some large genus.

[00:20:08] Speaker 00:
One of ordinary skill in the art at most would go through the six that SAGI discloses are important.

[00:20:16] Speaker 00:
And it's important to note that when we look at Hirasawa,

[00:20:22] Speaker 00:
And we're trying to decide, and this is one of the questions that the court asked about, and one of the responses my friend gave.

[00:20:34] Speaker 00:
When we're looking at Harasawa, and Sumitomo refers to all this other teaching away, the reason why, and the board doesn't just conclude that Harasawa

[00:20:50] Speaker 00:
is more persuasive.

[00:20:51] Speaker 00:
If you read the board's analysis on the page prior, the board discusses how Hirasawa is actually the closer and most relevant prior art.

[00:21:03] Speaker 00:
Hirasawa is a sumitomo researcher presenting data on exactly the drug at issue in this case.

[00:21:16] Speaker 00:
The very first paragraph of Hirasawa states begins with the assumption or the knowledge already that loracidone has few extrapyramidal effects.

[00:21:36] Speaker 00:
And then it wants to see... I'm sorry.

[00:21:39] Speaker 02:
That's not what's at issue.

[00:21:41] Speaker 02:
All the atypicals have few extrapyramidal effects.

[00:21:44] Speaker 02:
Weight gain's not one of those.

[00:21:46] Speaker 00:
Well, it starts with that, and this is why we want to investigate it.

[00:21:52] Speaker 02:
Correct me if I... I mean, my understanding was the typicals, the big problem was...

[00:22:01] Speaker 02:
extra pyramidal effects, motor control, whatnot.

[00:22:04] Speaker 02:
The atypicals came in and their great selling point was much, much reduced extra pyramidal effects, but weight gain is not an extra pyramidal effect.

[00:22:15] Speaker 00:
Right, and then it goes on to, then Hirosawa goes on, again, only looking at loracidone,

[00:22:25] Speaker 00:
We have a Sumitomo scientist saying that the results of looking at the binding affinities for loracidone, which it refers to as SM13496, that in addition to treating schizophrenia very well, based on these low binding affinities for the alpha-1, H1, and 5-HT2C receptors, it is suggested that

[00:22:55] Speaker 00:
the weight gain effect would be weak.

[00:22:58] Speaker 00:
And as to the safety concerns that my friend has talked about, Hirasawa also states that it is also suggested that those cardiovascular negative effects will also be weak in this case.

[00:23:17] Speaker 00:
And these other references... You can see though that the

[00:23:23] Speaker 01:
Board failed to appropriately address the safety concerns that were raised by opposing counsel?

[00:23:29] Speaker 00:
No, I don't because they are correct that the safety concern is not something that's claimed.

[00:23:37] Speaker 00:
Certainly when Saji's patent, Sumitomo's patent on the drug, that those safety concerns, at least that patent is enabled for all that it teaches.

[00:23:52] Speaker 00:
And so it's enabled as far as the PTO needs to address safety concerns.

[00:23:57] Speaker 00:
Any concerns beyond that, as this court has held on multiple occasions, are safety concerns are really for the FDA to examine.

[00:24:06] Speaker 02:
I'm sure safety concerns don't play into a motivation of a skilled artisan to move down the path.

[00:24:14] Speaker 02:
Have you really said that?

[00:24:16] Speaker 00:
I'm sorry, Your Honor.

[00:24:18] Speaker 02:
You didn't say that.

[00:24:19] Speaker 00:
I didn't say that.

[00:24:21] Speaker 02:
That seems to me the point.

[00:24:23] Speaker 00:
There is a lower threshold to enable, as far as safety concerns, to enable a patent or enable the prior art as to, you know, as it relates to

[00:24:36] Speaker 00:
the invention now claimed, than exists at the FDA.

[00:24:40] Speaker 00:
And in any event, Kurosawa, to say that even without reciting it in its claims, because they could have just as easily, if that was really something they wanted to claim, said without inducing clinically significant weight gain and without causing serious cardiovascular events, they didn't say that.

[00:25:03] Speaker 00:
That's not their claim.

[00:25:05] Speaker 02:
Do I remember, the board, you read that the half sentence in Horosawa, therefore it is suggested that its cardiovascular system and central suppressive side effects and weight gain effect are weak.

[00:25:23] Speaker 02:
The board certainly pointed to the last bit, weight gain effect are weak.

[00:25:27] Speaker 02:
Did it say anything about the

[00:25:30] Speaker 02:
Excuse me, you really do have to let me finish my question.

[00:25:36] Speaker 02:
I'm sorry that I take a little bit more time than other people do, but please listen.

[00:25:41] Speaker 02:
Did the board address this portion of the sentence about cardiovascular system side effects are weak, which you cited as indicating not a safety problem?

[00:25:57] Speaker 00:
The board certainly quoted

[00:26:00] Speaker 00:
When the board quoted Harasawa, they actually quoted also about the cardiac events.

[00:26:07] Speaker 00:
They did not make findings on that because they'd already decided that there was no nexus, so they didn't delve further into Harasawa's teaching.

[00:26:17] Speaker 00:
But the board certainly recognized that Harasawa predicts few cardiovascular events because they quoted that language.

[00:26:26] Speaker 02:
In a context discussing safety?

[00:26:30] Speaker 00:
No, that's what I'm saying there.

[00:26:34] Speaker 00:
And again, I apologize for interrupting, Your Honor.

[00:26:40] Speaker 00:
So those are our reasons.

[00:26:44] Speaker 00:
I think the board, in compliance with this court's case law, correctly found that there is no nexus for the safety issue.

[00:26:54] Speaker 00:
But even if there were a nexus, Harasawa

[00:26:58] Speaker 01:
indicates that this wouldn't be a problem

[00:27:12] Speaker 00:
That claim construction issue is really a red herring.

[00:27:16] Speaker 00:
And to the extent that there are inconsistencies in what the board said, I would answer it in a couple of ways.

[00:27:23] Speaker 00:
One is that much of the boards going back and forth is really

[00:27:32] Speaker 00:
an instrument of the fact that Sumitomo wouldn't commit to a claim construction.

[00:27:38] Speaker 00:
Even now, Sumitomo won't commit to a claim construction.

[00:27:42] Speaker 00:
And so the board was saying, well, even if it is, as you're now positing a population of people, all we need is still, you know, there are going to be these outliers who will satisfy it.

[00:27:54] Speaker 00:
But that's not what's important here.

[00:27:56] Speaker 00:
What's important here is, and

[00:28:01] Speaker 00:
and that's why I say this is a red herring, SAGI teaches 80% of the claimed range.

[00:28:10] Speaker 00:
So SAGI teaches administering loracidone at a dose at the 20 to 100% range or 80% of the claimed range.

[00:28:27] Speaker 00:
And if we assume

[00:28:30] Speaker 00:
as Sumitomo argues, that people given that dosage are not going to experience clinically significant weight gain, then certainly SAGI teaches a population of patients.

[00:28:45] Speaker 00:
And so it's really a red herring.

[00:28:49] Speaker 00:
But I would also point out that the board did say, despite what it may have said in its discussion of Braintree,

[00:28:57] Speaker 00:
The board says at APPX 9, APPX 10, and APPX 24 that a patient plus the word comprising means one or more.

[00:29:11] Speaker 00:
And finally, even if you don't agree that the board handled it correctly or not,

[00:29:21] Speaker 00:
Given the substantial overlap in that SAGI teaches at least 80 percent, with the exception of a few outliers, a dose in which 80 percent of the people in the claimed range will experience no clinically significant weight gain, this really is a moot point, but even if you don't agree with that and you feel that the board nishandled the construction,

[00:29:45] Speaker 00:
That would be really a harmless error, given the facts of this case, similar to the court's decision in Nanquest v. Vidal, where the district court was looking at a method of treating cancer and the district court said it's just killing one or more cancer cells.

[00:30:05] Speaker 00:
And this court said, well, it's actually more than that, but there's enough factual evidence here that the prior art would

[00:30:14] Speaker 00:
provide a reasonable expectation that this particular cancer drug would kill a substantial portion of cancer cells.

[00:30:23] Speaker 00:
And so those are the reasons why I really think this is a red herring.

[00:30:30] Speaker 00:
As far as the burden of persuasion,

[00:30:35] Speaker 00:
The board never shifted the burden of persuasion.

[00:30:37] Speaker 00:
The board followed this court's precedent.

[00:30:39] Speaker 00:
This court's precedent says that when you have overlapping range, and here, again, we have a substantially overlapping range, dose range, that creates a presumption of obviousness.

[00:30:53] Speaker 00:
And when you have a presumption of obviousness, the burden shifts, the burden of production, not the burden of persuasion, shifts to, in this case, the patent owner

[00:31:04] Speaker 00:
to come forward with rebuttal evidence.

[00:31:07] Speaker 00:
The rebuttal evidence as I stated earlier is related to first generation antipsychotic drugs.

[00:31:18] Speaker 00:
It's directed to whole classes of drugs.

[00:31:24] Speaker 00:
I'm sorry.

[00:31:25] Speaker 02:
What did he say is directed to the first generation?

[00:31:29] Speaker 02:
I missed what the pronoun was.

[00:31:31] Speaker 00:
I'm sorry.

[00:31:32] Speaker 00:
Sumitomo's rebuttal evidence to try to rebut Harasawa is directed to first generation antipsychotics.

[00:31:43] Speaker 00:
The one's called Typicals.

[00:31:44] Speaker 00:
Yes.

[00:31:45] Speaker 00:
And in addition,

[00:31:48] Speaker 00:
It's not, so that's one reason that it's not even the closest prior art.

[00:31:54] Speaker 00:
And so when you say what a person of ordinary skill in the art, what are they going to be looking to?

[00:32:02] Speaker 00:
The board found that Loracidone was the closest prior art and they correctly concluded that a person of ordinary skill in the art wouldn't ignore that.

[00:32:15] Speaker 00:
And again, I'd like to point out

[00:32:18] Speaker 00:
that Sumitomo is the owner of this patent of SAGI, the patent on the racidone.

[00:32:25] Speaker 00:
And it's Sumitomo's own scientist who's published that I've looked at the racidone, and I predict that it's going to have a weak effect on weight gain, and it's going to have a weak effect on cardiovascular issues.

[00:32:40] Speaker 00:
And so it's really their own prior art that is suggesting the claimed invention.

[00:32:46] Speaker 01:
If we find that there was some legal error in terms of the inherency analysis, for example, I assume you would agree with a vacancy remand under those circumstances?

[00:32:57] Speaker 00:
No, for two reasons.

[00:32:58] Speaker 00:
The first reason is that the board just didn't find it was inherent.

[00:33:01] Speaker 00:
They found that even if it wasn't, they didn't express it this way.

[00:33:05] Speaker 00:
They said inherent and expected.

[00:33:09] Speaker 00:
So to me, it's not inherent because it's expected, it's inherent and, and that's what petitioner argued.

[00:33:16] Speaker 00:
So I would say that even if you don't believe it's inherent, it is reasonably expected.

[00:33:21] Speaker 00:
The second point I would like to make is that there is no petitioner in this case.

[00:33:26] Speaker 00:
The petitioner has dropped out, the USPTO has stepped in to fill its shoes, and the patent has expired.

[00:33:35] Speaker 00:
Can't say that this 100% would happen, but it's highly likely that the board would not, under these circumstances, if this case were remanded, re-hear this case or continue further on this case.

[00:33:51] Speaker 02:
There's no specific rule about that?

[00:33:53] Speaker 00:
There's no specific rule about that.

[00:33:54] Speaker 02:
It's just a common practice.

[00:33:56] Speaker 00:
Pardon me?

[00:33:57] Speaker 00:
It's a common practice.

[00:33:59] Speaker 00:
Well, I can't speak to whether it's common or not.

[00:34:06] Speaker 00:
It's just likely because there's no petitioner to present that other argument.

[00:34:12] Speaker 00:
And then the patents also expired.

[00:34:14] Speaker 00:
So there's a question about, you know, there are the questions that come up when a patent is expired.

[00:34:22] Speaker 02:
But... I assume you don't have any information about whether this case is effectively moot.

[00:34:29] Speaker 00:
uh... you know because uh... that the board would not even mister saunders doesn't seem to have the information so the unlikely you would like to start a check uh... we yet uh... uh... uh... at the board wouldn't tell us in advance what they would do they would say oh well we have to see what the court comes comes down with that and you know i

[00:34:53] Speaker 00:
I can't testify or provide some sort of point of view as to what that is, other than to say I would think it would be likely.

[00:35:02] Speaker 02:
And the petition did not make an anticipation argument, right, or a challenge, or did it?

[00:35:08] Speaker 02:
Right, it did not.

[00:35:10] Speaker 02:
And I suspect that it's because... Isn't there a piece of anticipation doctrine that allows

[00:35:17] Speaker 02:
a substantially overlapping range being treated as effectively the same as the challenged range?

[00:35:30] Speaker 00:
The only law I could think of is that anticipation is the epitome of obviousness.

[00:35:36] Speaker 00:
But I do know that in the world of 103, in the world of obviousness,

[00:35:45] Speaker 00:
A substantial overlap creates that presumption of obviousness.

[00:35:49] Speaker 00:
And so, I mean, I think this court, I think there could be a little doubt that the claimed range is obvious.

[00:35:57] Speaker 00:
Then we're talking about whether the lack of clinically significant weight gain is obvious.

[00:36:04] Speaker 00:
And even if you don't agree that it's inherent, harasawa certainly suggests that it is.

[00:36:11] Speaker 00:
And harasawa is the closest prior art.

[00:36:16] Speaker 00:
All right, thank you very much, Your Honors.

[00:36:17] Speaker 03:
Thank you, Your Honors.

[00:36:24] Speaker 03:
As Judge Toronto's question picked up on, the statement about cardiovascular effect in Horosawa is not anything the board relied on or made findings in connection with.

[00:36:35] Speaker 03:
It was refusing to consider the safety profile.

[00:36:38] Speaker 03:
Another important thing to keep in mind about Horosawa and the point of, oh, it's our own scientists doing it,

[00:36:44] Speaker 03:
Orisawa was in 1999.

[00:36:46] Speaker 03:
We're talking about a priority date in 2002.

[00:36:49] Speaker 03:
They're intervening art in the meantime that needs to be considered, most notably the Zipracidone label in 2001 that comes in and talks about the risk of sudden death and essentially says use other drugs first.

[00:37:07] Speaker 03:
So you can't go back to 1999 and read that one reference in isolation.

[00:37:12] Speaker 03:
In terms of the population and patient switch, it should be remanded for the board to make the proper findings.

[00:37:20] Speaker 03:
There's no finding about population under Chenery.

[00:37:23] Speaker 03:
This court can't substitute reasoning for the board.

[00:37:28] Speaker 03:
And on the burden shifting, I heard an argument today about, well, the burden of production shifts.

[00:37:33] Speaker 03:
But we clearly came forward and met our burden of production with all of the evidence we came forward with.

[00:37:39] Speaker 03:
And to be clear, the evidence that's presented and discussed at length in our brief about there not being a consistent relationship between the binding profiles and weight gain, every single one of those drugs that's mentioned in the diagrams in our brief, those are all atypical antipsychotics.

[00:37:57] Speaker 03:
So those are not first generation typical, those are atypical

[00:38:00] Speaker 03:
They're in this area.

[00:38:02] Speaker 03:
This is also an atypical.

[00:38:04] Speaker 02:
Ms.

[00:38:05] Speaker 02:
Kelly referred to language of the board.

[00:38:07] Speaker 02:
I think it was inherent or expected.

[00:38:11] Speaker 03:
I think this is another reason to remand.

[00:38:20] Speaker 03:
You won't be surprised.

[00:38:21] Speaker 03:
No, because the section of the board's opinion from 22 to 24, I have tremendous difficulty

[00:38:29] Speaker 03:
following what it's saying.

[00:38:31] Speaker 03:
It starts by talking about Horisawa.

[00:38:33] Speaker 03:
It then says, well, you wouldn't merely dismiss Horisawa.

[00:38:36] Speaker 03:
It then pivots to its patient, patient, inherency theory.

[00:38:43] Speaker 03:
And there is sort of woven in there some language about reasonable expectation of success sort of later on, but flowing out of maybe the inherency argument.

[00:38:56] Speaker 01:
So I do want to talk a little bit to you about the disposition, because I feel like the disposition here seems, as it always is, important.

[00:39:03] Speaker 01:
It seems like there's a bit of disagreement.

[00:39:06] Speaker 01:
So in terms of if we were to just find error in the Inherency Analysis, do you think that alone is a basis to remand, or would it be what I heard opposing counsel argue?

[00:39:19] Speaker 01:
Do you need to find error in both the Inherency Analysis, and I think she said reasonable expectation analysis.

[00:39:24] Speaker 03:
Well, with the safety error, that supersedes all of it.

[00:39:29] Speaker 03:
So that's a remand no matter what.

[00:39:31] Speaker 03:
We've argued both prongs because we think there are errors on both of them, but I think the real answer is if there's an error on inherency, it's sufficiently unclear what's being said about reasonable expectation of success.

[00:39:46] Speaker 03:
You're maybe not saying the board is wrong in that context, but at least sending it back, it's going back anyway to get that clarification from the board as what are you saying?

[00:39:57] Speaker 03:
How did these arguments link together?

[00:39:59] Speaker 03:
Because you have this inherently finding dropped right in the middle of it.

[00:40:03] Speaker 03:
And so it's not at all clear that the board is saying something independent on reasonable expectation of success or whether it's basing that expectation argument

[00:40:12] Speaker 03:
on the inherency argument that it stuck between the discussion of Horosawa and that statement.

[00:40:19] Speaker 02:
To return to where we began, do you have any

[00:40:25] Speaker 02:
thoughts about guidance on whether we need to declare this moot?

[00:40:33] Speaker 03:
I struggle with this because I think it is a genuinely difficult question.

[00:40:38] Speaker 03:
It's not traditionally in the context of someone who owns property, which has been vacated

[00:40:47] Speaker 03:
abrogated by the government.

[00:40:49] Speaker 03:
The analysis expired of its own.

[00:40:51] Speaker 02:
Sure.

[00:40:51] Speaker 03:
But I don't think the analysis for our standing on appeal looks quite the same in that circumstance as a potential infringer.

[00:41:00] Speaker 02:
No, no, no.

[00:41:00] Speaker 02:
Just because there is this reach back claim.

[00:41:02] Speaker 02:
That's quite different.

[00:41:03] Speaker 02:
But this is also the unusual circumstance where there shouldn't have been any entrance.

[00:41:11] Speaker 03:
Right.

[00:41:11] Speaker 03:
And so what it has to say is we just don't

[00:41:14] Speaker 03:
And the law gives us the entitlement to discover within the next six years that there was somebody who jumped the gun in what they were supposed to be doing, or there was a compounding pharmacy, or there was some illegal use.

[00:41:27] Speaker 03:
But in Canada, the court, I cannot say to you that we are aware of such an instance and given the regulated conduct, it's much less likely than in another area that there would be.

[00:41:41] Speaker 03:
Our most important interest, just to be frank with the court, is having this reasoning be abrogated here because it's incorrect.

[00:41:51] Speaker 03:
If ultimately the path to that is a Munson where vacant are because of mootness, because there's enough uncertainty in a regulated industry like that, then we're

[00:42:02] Speaker 03:
We're not going to fight the court on that.

[00:42:04] Speaker 03:
We think with the look-back period, there is enough there for the court to have jurisdiction and to affirmatively say there have been these errors made, which will provide guidance to the board going forward.

[00:42:16] Speaker 03:
But if it's sufficiently concerned about its jurisdiction that it thinks it's moot, then at the very least, there should be a Monsignor Baker term.

[00:42:23] Speaker 02:
Thank you.

[00:42:23] Speaker 02:
Thanks to all counsel.

[00:42:25] Speaker 02:
The case is submitted.