[00:00:00] Speaker 01:
Next case for argument is 23-1374, Decatur Pharmaceutical Company versus Norwich Pharmaceuticals.

[00:00:07] Speaker 01:
Mr. Landman, am I saying that right?

[00:00:09] Speaker 00:
That's correct, Your Honor, thank you.

[00:00:10] Speaker 01:
Please proceed.

[00:00:11] Speaker 00:
May it please the court, briefly, before I get into the merits, as set forth in our motion to expedite the appeal, time is of the essence.

[00:00:18] Speaker 00:
If this court doesn't issue a mandate well in advance of the August 24th expiration of Takeda's pediatric exclusivity period, Takeda will win by default, even if this court later reverses and vacates the judgment.

[00:00:30] Speaker 03:
Although this... Can I just ask you, since you raised that, if we...

[00:00:33] Speaker 03:
I mean, frankly, it sounds impossible to me to issue a mandate because they have a right to ask for a rehearing, which is going to delay the mandate for 45 days.

[00:00:41] Speaker 03:
But assuming we agree with you on every single issue here, which I think you have to win on, and we expedite the mandate, what do you get if we find these patents, all of them, invalid before August?

[00:00:55] Speaker 00:
We would then be able to obtain FDA approval and bring our product to market, or nowhere to be able to bring its product to market.

[00:01:01] Speaker 03:
Well, so does everybody else in August.

[00:01:04] Speaker 00:
On August 24th, correct.

[00:01:06] Speaker 03:
Do you get an exclusive period after August?

[00:01:10] Speaker 00:
Norwich does not.

[00:01:11] Speaker 00:
No, it would be the sole generic product on the market until the expiration of the pediatric exclusivity period.

[00:01:17] Speaker 01:
But you want us to get it out before August 24th, because you'd be the exclusive generic between now and then.

[00:01:23] Speaker 01:
Is that right?

[00:01:24] Speaker 00:
Well, that's one of the reasons.

[00:01:26] Speaker 00:
But also, once August 24th hits, then there's no pediatric exclusivity, and there's nothing stopping Norwich or anyone else from going to market, including the district court's order below only stops Norwich from going to market until August 24th.

[00:01:38] Speaker 03:
So we not only have to get it out before August 24th or whatever.

[00:01:43] Speaker 03:
We have to get it out substantially before then, but for you to get any real benefit.

[00:01:47] Speaker 00:
Obviously, the sooner the better.

[00:01:50] Speaker 00:
But yes, we would then have to deal with FDA and get FDA approval.

[00:01:53] Speaker 00:
And obviously, as Your Honor mentioned, move to expedite the issuance of the mandate.

[00:01:58] Speaker 03:
How long would your exclusive rights last?

[00:02:02] Speaker 00:
Just until August 24.

[00:02:03] Speaker 00:
The district court's decision, there are several errors from the district court's decision.

[00:02:12] Speaker 03:
The appellee suggested you have to win on every single one of these claims for us to rule in your favor.

[00:02:18] Speaker 03:
Is that correct?

[00:02:20] Speaker 00:
This court needs to find that the district court committed a reversible error and vacate the judgment below on every one of the claims.

[00:02:26] Speaker 00:
How many claims are there?

[00:02:28] Speaker 00:
I actually forget the exact number of claims.

[00:02:31] Speaker 03:
It's like 14 or something, right?

[00:02:32] Speaker 00:
That's correct, Your Honor.

[00:02:33] Speaker 03:
And most of these are a clear error standard.

[00:02:35] Speaker 00:
Some of them are clear error, but I think, in fact, the district court's errors do meet that standard.

[00:02:41] Speaker 00:
And they really fall into five buckets.

[00:02:43] Speaker 01:
Wait, that's a lot of buckets to be carrying around, isn't it?

[00:02:49] Speaker 03:
The general rule for an appellate argument is you pick your three strongest arguments and make to us.

[00:02:54] Speaker 03:
And if you have to make, you pick more than three, then you haven't picked out the three strongest.

[00:02:59] Speaker 03:
Well, you have to win on a bunch of them.

[00:03:05] Speaker 03:
I just don't understand why we're here for something that we're not going to get the decision out in time.

[00:03:10] Speaker 03:
And I fail to see how you can win on 14 different claims when a bunch of them are under a clear error standard.

[00:03:17] Speaker 00:
So your honor.

[00:03:18] Speaker 03:
I know you're representing your client.

[00:03:20] Speaker 03:
But at some point, like we suggested earlier, you tell your client this is a waste of the court's time and a waste of the client's money.

[00:03:28] Speaker 00:
So with all due respect, and we're very respectful of the court's time and the court's efforts, we don't think it's a waste of the court's time or a waste of money.

[00:03:37] Speaker 00:
And the district court had to deal with a patent ticket that was created by Tecate's predecessor.

[00:03:43] Speaker 00:
And because of that, there were numerous issues that were set forth before the district court.

[00:03:48] Speaker 00:
But some of them really scream out for this court reversing.

[00:03:52] Speaker 00:
And if I can just run through it.

[00:03:53] Speaker 03:
But it's not just some of them that you have to win on.

[00:03:55] Speaker 03:
All of them.

[00:03:57] Speaker 03:
I mean, I think you have some really good arguments on some of this stuff.

[00:04:00] Speaker 03:
But it doesn't help if you have some arguments that are not going to get over a clear-air standard on other things.

[00:04:05] Speaker 00:
Well, we do have to win on all of them because the patents all expire on the same day.

[00:04:08] Speaker 00:
Because the way this patent ticket was put together, they all internally disclaim and expire on the same day.

[00:04:14] Speaker 00:
So yes, it is different than a case where patents expire on different days.

[00:04:17] Speaker 00:
But there are a lot of appeals where you do have to win on all the issues that the district court decided in order to get relief below.

[00:04:24] Speaker 00:
Turning to the district court's errors, as I mentioned, there are really five that stand out, we think, that require reversal and vacating the judgment below.

[00:04:33] Speaker 00:
The first is that the court defined abuse, which was the problem to be solved in stark contrast to the testimony of both sides' experts and the prior art.

[00:04:43] Speaker 00:
The second is that it rejected the Patrick Pro Drug reference by requiring a poster to follow a convoluted path

[00:04:50] Speaker 00:
indeed a path that both sides agreed was impossible, instead of the straightforward path set forth by Norwich's expert.

[00:04:56] Speaker 00:
The third is that it excluded Norwich's salt expert, even though he undisputably met both parties' POSA definitions, and he was actually qualified by the district court at trial as an expert, without objection.

[00:05:09] Speaker 00:
The fourth is that it ignored evidence showing that the pharmacokinetics are inherent in the LDX compound, including admissions by the inventor chair.

[00:05:19] Speaker 00:
And the fifth is that it found no motivation or reasonable expectation on administering LDX to treat ADHD simply because the compound hadn't been tested, gone through clinical testing.

[00:05:31] Speaker 00:
These really are red flags for this court.

[00:05:34] Speaker 00:
Starting with the prodrug limitations.

[00:05:36] Speaker 00:
So the district court's incorrect definition of abuse led for its failure to find a motivation to combine the deamphetamine lead compound, the lead compound the court found that no one can test here, by making a prodrug.

[00:05:50] Speaker 00:
And as we discussed in our opening briefs at pages 14 to 16, the district court should have found that motivation straightforward by walking through its fact findings.

[00:05:58] Speaker 00:
But rather than follow those to its natural conclusion, the district court turned to motivation to make a pro drug.

[00:06:04] Speaker 00:
That motivation being that extended release products could be defeated by crushing.

[00:06:09] Speaker 00:
The district court incorrectly took that motivation as a definition of abuse and defined the problem of the amphetamine abuse as a problem arising from crushing.

[00:06:19] Speaker 00:
That led the court then to incorrectly look for a motivation to solve the crushing problem and not the problem of abuse, which the experts agreed was caused by the euphoria that happens when you take deamphetamine and the spike of active in the blood by the deamphetamine.

[00:06:33] Speaker 01:
Well, euphoria creates the desire to abuse the drug.

[00:06:39] Speaker 01:
Correct.

[00:06:40] Speaker 01:
But the abuse is not euphoria.

[00:06:43] Speaker 01:
That's not the abuse.

[00:06:43] Speaker 01:
That's the result of the abusing.

[00:06:46] Speaker 01:
So the abusing has to be the method by which you cause the euphoria to occur, correct?

[00:06:51] Speaker 00:
No, I think the abuse, so sort of backing up, the problem to be solved here is preventing abuse that was happening with deamphetamine and stopping people from wanting to abuse deamphetamine.

[00:07:03] Speaker 00:
So the solution to that that the experts agreed on was stopping the spike of active in the blood.

[00:07:08] Speaker 00:
There were a couple of alternatives discussed.

[00:07:10] Speaker 00:
There was the extended release formulation alternative that was discussed.

[00:07:13] Speaker 00:
Those tablets, everyone agreed you can crush those and defeat that extended release function.

[00:07:20] Speaker 01:
That's exactly the point.

[00:07:21] Speaker 01:
Abuse is how do I cause myself to have this euphoric feeling?

[00:07:27] Speaker 01:
So abuse is action.

[00:07:28] Speaker 01:
The action could be crushing, it could be injecting, it could be snorting, it could be taking 15 pills instead of one.

[00:07:34] Speaker 01:
Right?

[00:07:34] Speaker 01:
I mean, the abuse is the act that one performs to cause the euphoria.

[00:07:41] Speaker 01:
Is that fair?

[00:07:42] Speaker 00:
So that is fair, but the inquiry the district court should have gone on is, what is the motivation to fix the euphoria?

[00:07:50] Speaker 00:
Because euphoria, as you said before, is what leads to the abuse.

[00:07:54] Speaker 00:
So the experts talked about on both sides that the euphoria was there from deamphetamine, and that APOSA would have wanted to solve that euphoria problem.

[00:08:03] Speaker 00:
So instead of getting

[00:08:05] Speaker 00:
hung up kind of on what abuse is, the district court should have been focused on what is the motivation opposed that would have been focused on, seeing that the amphetamines were being abused and that abuse stemmed from the euphoria of the deamphetamine release.

[00:08:20] Speaker 00:
Turning to the second bucket I mentioned, which was the Patrick reference.

[00:08:28] Speaker 00:
Consistent with the court's lead compound law, Dr. Milano set forth how Opposa would have applied the teachings of Patrick, which was to create a prodrug using a lysine promyote and attaching that to a primary amine group to blunt the release.

[00:08:43] Speaker 00:
Instead of doing that, the district court came up with this complicated cookbook analogy and said that Opposa would have treated Patrick as, quote, like a cookbook.

[00:08:52] Speaker 00:
But it did that despite the fact that experts on both sides

[00:08:56] Speaker 00:
said that it was impossible to treat Patrick that way and to treat the amphetamine that way.

[00:09:00] Speaker 00:
And obviousness can't be defeated by coming up with some complicated, non-existent solution when there's a simpler solution presented by the POZA.

[00:09:09] Speaker 00:
And when the district court's error there is corrected, the only conclusion that can be reached is that Patrick creates both a motivation and a reasonable expectation.

[00:09:18] Speaker 01:
Our standard is an error.

[00:09:19] Speaker 01:
It's clear error.

[00:09:22] Speaker 01:
I don't see how the district court clearly erred in finding that you failed to prove a skilled artist would have been motivated to modify the D-amphetamine with Patrick's LDZ pro-drug example.

[00:09:31] Speaker 00:
Well, it was the court looking or treating Pat.

[00:09:35] Speaker 01:
Dr. Kilbenov?

[00:09:36] Speaker 01:
I don't know if I'm saying his name right.

[00:09:37] Speaker 01:
He offered testimony, and the district court expressly found that more credible than Dr. Malamow's.

[00:09:44] Speaker 01:
Do you expect me to dive behind that?

[00:09:46] Speaker 00:
No, obviously, the court's job here is not to die behind credibility determinations.

[00:09:53] Speaker 00:
But the district court used this cookbook analogy that neither expert was putting forth.

[00:09:58] Speaker 00:
And the district court looked at Patrick as like a cookbook.

[00:10:01] Speaker 00:
And that was where the district court went wrong.

[00:10:03] Speaker 00:
Instead of following the teachings that Opposal would have applied to the lead compound, that is what Patrick taught, the district court went through this complicated cookbook analogy and created a complication that frankly wasn't there.

[00:10:15] Speaker 00:
Turning to the SALT limitations, the District Court's post-trials to respond to the exclusion of Dr. Sloan, the SALT expert.

[00:10:23] Speaker 00:
led to its improper conclusions here was clear error and requires reversal.

[00:10:29] Speaker 00:
Dr. Sloan was a professor of medicinal chemistry, and here's three undisputed facts.

[00:10:33] Speaker 00:
He met both parties, posed the definitions.

[00:10:36] Speaker 00:
He was qualified by the district court at trial as an expert in salt selection without objection, and no one filed a motion to exclude him.

[00:10:44] Speaker 00:
He possessed all the necessary experience, including working with mucilate salts.

[00:10:49] Speaker 00:
And there is no dispute that the district court at the time encouraged the parties to dispense with normal foundational testimony about an expert's qualifications.

[00:10:57] Speaker 00:
It was simply improper and Takeda points to no case in which a court later in time changes the pose of definition to exclude an expert.

[00:11:05] Speaker 00:
And for that reason, the court's conclusions with respect to assault limitations should be reversed and the district court should be vacated.

[00:11:12] Speaker 01:
But I thought the district court excluded Dr. Sloan's testimony for five separate reasons.

[00:11:17] Speaker 01:
So why don't you go through each of these?

[00:11:19] Speaker 01:
He had never performed assaults for me, even though he applied to skilled artists and would routinely perform them.

[00:11:24] Speaker 01:
He mistakenly said at his deposition he had reviewed drafts of Dr. Malamow's expert report.

[00:11:29] Speaker 01:
So therefore, he was sort of not credible.

[00:11:31] Speaker 01:
He stated that his own patents are not enabled, but he never told the PTO.

[00:11:35] Speaker 01:
He then said the district court based also on its own observations of his demeanor on the stand, which he found not to be credible.

[00:11:43] Speaker 01:
And then finally, the district court concluded his testimony was internally inconsistent.

[00:11:47] Speaker 01:
So why don't you go ahead and tell me why every one of those five reasons is wrong?

[00:11:51] Speaker 01:
Because that's what you've got to get to, to get slowed in.

[00:11:53] Speaker 00:
Well, so those five reasons.

[00:11:55] Speaker 01:
Your three remaining minutes.

[00:11:56] Speaker 00:
Yeah.

[00:11:56] Speaker 00:
I do want to reserve a couple of minutes, but really quickly, those five reasons were credibility determinations the court ran through.

[00:12:03] Speaker 00:
He only excluded Dr. Sloan on the first reason, that Dr. Sloan had not personally performed a SALT screening.

[00:12:10] Speaker 00:
And Dr. Sloan said, I have not personally performed it, but it's routine in the art, it's routine part of SALT selection.

[00:12:15] Speaker 00:
And that's where the district court went wrong, because that wasn't required by the POSA definition.

[00:12:19] Speaker 01:
He didn't say it's routine in the art.

[00:12:21] Speaker 01:
He said ordinarily skilled artisan would have routinely performed it.

[00:12:25] Speaker 01:
So how is he an ordinarily skilled artisan if he's never done something that an ordinarily skilled artisan would have done?

[00:12:31] Speaker 00:
Yeah, I guess I'd say two things, Your Honor.

[00:12:33] Speaker 00:
One, that wasn't part of the pose of definition that the court applied.

[00:12:36] Speaker 00:
The court apparently went back to responding.

[00:12:38] Speaker 00:
No party was saying that that is part of the pose of definition.

[00:12:42] Speaker 01:
The guy you want to testify said it, and then the district court says, okay, you're saying you have to have done this to be an ordinarily skilled artisan, and then you're admitting you didn't do it.

[00:12:50] Speaker 01:
He's not credible.

[00:12:51] Speaker 01:
That's it.

[00:12:52] Speaker 00:
Done.

[00:12:52] Speaker 00:
So that's the credibility part.

[00:12:54] Speaker 00:
But first, I think this court needs to deal with the exclusion part.

[00:12:57] Speaker 00:
But maybe more importantly, Your Honor, the court failed to then consider any of the prior art that was put forward on the SALT issues.

[00:13:04] Speaker 00:
This court in the Bear Farmer case and the Pfizer case we cited in our papers says it's improper for a district court to do that, even after making credibility determinations.

[00:13:13] Speaker 01:
Do you want to save time for rebuttal?

[00:13:15] Speaker 00:
I do.

[00:13:15] Speaker 01:
Thank you, Your Honor.

[00:13:17] Speaker 02:
Please, the court.

[00:13:18] Speaker 02:
Good morning.

[00:13:18] Speaker 02:
Ed Haug for the plaintiff.

[00:13:20] Speaker 02:
uh... apel e decayed a pharmaceutical company so jump right into answering a question i heard about what is norwich really trying to do here uh... we we filed a motion on this actually in discuss what we think they're doing course i'm speculating to the extent i'm not part of their however norwich has no exclusivity right now at all they're in the judge's infringer on fourteen claims across nine paths following the trial that

[00:13:49] Speaker 02:
we had in New Jersey in November.

[00:13:53] Speaker 02:
So now they cannot launch until the pediatric exclusivity expires, which is in August of 2023.

[00:14:00] Speaker 02:
There's a six-month pediatric exclusivity period that attaches to the end of the patent explorations.

[00:14:07] Speaker 02:
All the patents in this case have already expired.

[00:14:10] Speaker 02:
They expired in February.

[00:14:13] Speaker 02:
What Norwich is looking to do, I believe, is get

[00:14:18] Speaker 02:
get a vacature of the decision below so they can argue they were never found to be an infringer and the patents were not found to be not invalid before they expired.

[00:14:31] Speaker 02:
And then they will argue probably pediatric exclusivity doesn't apply to them, even though it does apply to all the other generic challengers that have gone before in a prior case that this court has already affirmed.

[00:14:46] Speaker 02:
That's what I think is behind all of this.

[00:14:49] Speaker 02:
Otherwise, this makes no sense whatsoever for Norwich to have even filed an ANDA so many years after everyone else has filed and lost on the same patents or overlapping patents.

[00:15:02] Speaker 02:
Going to the trial, we moved for summary judgment shortly before trial.

[00:15:06] Speaker 02:
Judge Chessler denied that motion because Norwich argued, judge, this is a battle of the experts, a classic battle of the experts.

[00:15:15] Speaker 02:
The judge agreed and said, we'll go to trial.

[00:15:18] Speaker 02:
We had the trial in November, and it was a battle of the experts.

[00:15:22] Speaker 02:
There were nine experts.

[00:15:25] Speaker 02:
And they battled and, in our view, Norwich lost that battle on each and every one of those experts.

[00:15:33] Speaker 02:
We just heard about Dr. Sloan, one of their experts.

[00:15:36] Speaker 02:
And the court found him to be lacking any credibility and gave his testimony zero weight.

[00:15:43] Speaker 02:
That is the judge's job at a trial.

[00:15:46] Speaker 02:
Dr. Sloan was in no way excluded.

[00:15:48] Speaker 02:
He testified, he was cross-examined, and he even came on from the media room.

[00:15:54] Speaker 01:
You're picking your easiest argument.

[00:15:56] Speaker 01:
What do we do if there are actually some problems with what the district court concluded?

[00:16:02] Speaker 01:
Like, for example, what if I had

[00:16:05] Speaker 01:
uh... problems with some aspects uh... but not others such that i wouldn't ultimately be vacating with regard to all fourteen claims and all of the different things should we should we do that or or what you know does it have any impact on the outcome of this case if we agree with them on some of their arguments but not all of the ones they need to i think the answer is no it has no practical outcome because

[00:16:33] Speaker 02:
unless you reverse or vacate every claim, all the arguments with respect to all the claims in this case, there will still be some patents remaining that have been found to be valid and infringed.

[00:16:47] Speaker 01:
And all of those patents are now expired.

[00:16:48] Speaker 01:
Correct.

[00:16:49] Speaker 01:
So there isn't necessarily a need for this court as we do in many cases to

[00:16:55] Speaker 01:
differentiate between the claims to prevent future litigation.

[00:17:01] Speaker 01:
This is it.

[00:17:01] Speaker 01:
This is the whole thing.

[00:17:03] Speaker 02:
That's correct, Your Honor.

[00:17:05] Speaker 02:
And the only thing remaining beyond expiration of these patents is the pediatric exclusivity, which is part of the judgment down below.

[00:17:14] Speaker 02:
namely that there and that cannot be approved until August of 2023.

[00:17:18] Speaker 02:
That still remains.

[00:17:20] Speaker 02:
And also, by agreement of the parties down below, there is the argument about whether or not this is an exceptional case.

[00:17:27] Speaker 02:
And that would arguably go to attorney's fees if such a motion is brought.

[00:17:32] Speaker 02:
It hasn't been brought at this stage.

[00:17:34] Speaker 02:
So the case is not moot, is what I'm really saying.

[00:17:38] Speaker 02:
And so I think if this court were to find that any of the

[00:17:43] Speaker 02:
patents are subject to remand for some reason.

[00:17:47] Speaker 02:
And we, of course, don't think any of them are for any reason.

[00:17:51] Speaker 02:
But I think that that's what we do in our briefs.

[00:17:53] Speaker 02:
And I think all the arguments are there.

[00:17:56] Speaker 02:
I don't even know what you're on.

[00:17:58] Speaker 01:
I feel like you just shot yourself in the foot and me along with you.

[00:18:02] Speaker 01:
So here's the problem.

[00:18:03] Speaker 01:
If you're going to tell me you're going to go back and move for attorney's fees, this is an exceptional case.

[00:18:07] Speaker 01:
If we, for example, were to rule 36 it because we agree with at least one of these five things not being overturned.

[00:18:13] Speaker 01:
Are you going to go back and argue to the district court, see, we rule 36, so they agree with everything and therefore this is an exceptional case and we should get attorney's fees?

[00:18:20] Speaker 01:
Because if so, then I've got to write an opinion because I don't agree with all of the things the district court did.

[00:18:24] Speaker 01:
I think he got some of them, or he or she got some of them wrong.

[00:18:27] Speaker 01:
So if you're going to go back and make this exceptional case argument and try and get attorney's fees, you just caused me to have to write an opinion because you don't win on all these.

[00:18:37] Speaker 03:
I mean, how can you make an exceptional case argument given what you just, I'm not suggesting you're going to, but you just stood up and said, you know, summary judgment was denied.

[00:18:45] Speaker 03:
This is a battle of the experts.

[00:18:46] Speaker 03:
I mean, when you call something a quintessential battle of the experts, that seems to me to be ordinary and the litigation, or ordinary litigation altogether.

[00:18:56] Speaker 03:
So, you know, I don't think we're asking you to say you're not going to, well, maybe, but not going to file an attorney's fees application, but it seems like the

[00:19:07] Speaker 03:
the way this case went out with a bunch of different issues, a very hard-fought case, and you prevailed on all of them, doesn't even come close to something that should be found to be exceptional.

[00:19:20] Speaker 02:
I was only giving the court the record.

[00:19:22] Speaker 02:
We agreed down below not to raise the issue of exceptional case or make a motion for fees, and we haven't.

[00:19:29] Speaker 02:
We just deferred it, all right?

[00:19:31] Speaker 02:
That's all we did, and then it's appealed.

[00:19:33] Speaker 02:
And Your Honor, to answer your question directly, no, I'm not looking to do that.

[00:19:37] Speaker 01:
OK, well, for the record, I think some of your arguments are affirms, and I think others of them are not.

[00:19:43] Speaker 01:
I don't think you deserve attorney's fees.

[00:19:45] Speaker 01:
That's my personal view.

[00:19:46] Speaker 01:
It's on the record.

[00:19:49] Speaker 02:
OK, Your Honor, I don't know which issues you're talking about that you would not affirm.

[00:19:53] Speaker 02:
I think we're right on all of the issues here.

[00:19:58] Speaker 01:
How about we start with the pro-drug approach issue then, since you're right on all of them.

[00:20:03] Speaker 01:
Abuse would clearly include taking multiple pills.

[00:20:07] Speaker 01:
Why isn't that part of the definition of abuse?

[00:20:10] Speaker 01:
Every expert said it was.

[00:20:12] Speaker 01:
No.

[00:20:12] Speaker 01:
The oral ingestion of multiple pills could create the same sense of euphoria.

[00:20:16] Speaker 01:
That would constitute abuse.

[00:20:18] Speaker 01:
Why did this district court judge focus exclusively on crushing, snorting, and injecting?

[00:20:22] Speaker 02:
I think the opinion of the district court is that that was not argued by the parties, that what they were arguing was

[00:20:28] Speaker 02:
crushing and then snorting or injecting the amphetamine.

[00:20:34] Speaker 02:
That was the problem to be solved.

[00:20:36] Speaker 02:
And the court also very clearly sets forth that Norwich, who has the burden of proof to show what the problem to be solved is, it's a question of fact, they didn't do it.

[00:20:46] Speaker 01:
Council, the problem to be solved was eliminating the euphoria that comes from abusing this drug.

[00:20:52] Speaker 01:
Every expert testified that you can also abuse this drug through taking multiple doses.

[00:20:58] Speaker 01:
Exceeding the recommended oral dosage can also be a way of getting that same euphoric feeling.

[00:21:05] Speaker 01:
So why didn't the district court get it wrong when the district court excluded that oral consumption of more pills from the definition of abuse?

[00:21:14] Speaker 02:
That was not the problem to be solved, which was urged by Norwich down below.

[00:21:20] Speaker 02:
They have the burden to set that forth.

[00:21:22] Speaker 02:
And that is a question of fact.

[00:21:24] Speaker 02:
And the court was looking at what the expert said and resolved the question of fact in the way he did.

[00:21:29] Speaker 02:
And went on from there and said, this is the problem to be solved.

[00:21:34] Speaker 02:
And he, I think, gave them the benefit of the doubt.

[00:21:36] Speaker 02:
He could have stopped right there and said, you haven't satisfied your burden for clear and convincing evidence to show what the problem to be solved is.

[00:21:44] Speaker 02:
He did it for them.

[00:21:46] Speaker 02:
And then we went on with the case.

[00:21:48] Speaker 02:
And he weighed all of the expert testimony on all the issues.

[00:21:54] Speaker 02:
and very clearly set forth how he evaluated those experts and how he decided them.

[00:21:59] Speaker 01:
So what was the district court's fact finding on no reasonable expectation of success in producing LDX?

[00:22:06] Speaker 02:
That LDX was not in the prior art at all.

[00:22:11] Speaker 02:
Lysine being conjugated to DMphetamine was completely unknown.

[00:22:16] Speaker 02:
That was a new innovation.

[00:22:18] Speaker 02:
So there was no motivation or reasonable expectation of success to combine lysine with D-amphetamine.

[00:22:25] Speaker 02:
The primary reference they relied on, which was Patrick, doesn't even disclose LDX.

[00:22:30] Speaker 02:
It discloses something else, a diazepam.

[00:22:33] Speaker 02:
And Patrick doesn't disclose anything about abuse.

[00:22:38] Speaker 02:
So there was no suggestion whatsoever to combine Patrick with anything.

[00:22:42] Speaker 02:
And there was no reasonable expectation of success.

[00:22:44] Speaker 02:
That's my understanding of what the court found.

[00:22:47] Speaker 02:
based on, again, all the experts that testified in this case.

[00:22:53] Speaker 01:
Well, on claim two of the 787 patent, I don't see where the district court actually made any necessary fact findings underlying obviousness with regard to the isolated LDX.

[00:23:05] Speaker 01:
I don't see those fact findings.

[00:23:07] Speaker 01:
So why shouldn't I vacate and remain for the district court to make those fact findings?

[00:23:11] Speaker 02:
I don't think that fact finding is necessary to conclude that Norwich didn't carry its burden on obviousness.

[00:23:20] Speaker 02:
It was not a specific fact finding, I don't think, that was required.

[00:23:23] Speaker 02:
He found LDX was not obvious.

[00:23:25] Speaker 02:
The prodrug was not obvious.

[00:23:26] Speaker 02:
The prodrug had never been used for treating ADHD.

[00:23:31] Speaker 02:
A dimethylate salt, which is then combined to the LDX, had never been approved by the FDA before.

[00:23:38] Speaker 02:
And so we go with respect to each and every one of these patents, respectfully.

[00:23:45] Speaker 02:
And I would like to, just before I conclude, I go back to the comment before about exceptional case.

[00:23:52] Speaker 02:
I was only setting forth the record below and, I thought, trying to address the possible question I heard, which was whether or not this case is moot because the patents have expired.

[00:24:03] Speaker 02:
And I was just pointing out that I think under the precedent of this court, it's not moot because if there's a claim for attorney's fees or if there's a pediatric exclusivity issue, then it's not moot.

[00:24:16] Speaker 02:
That's the only point I was trying to make.

[00:24:18] Speaker 02:
Now, unless Your Honors have any other questions.

[00:24:20] Speaker 01:
No.

[00:24:21] Speaker 01:
Thank you.

[00:24:21] Speaker 00:
Thank you.

[00:24:23] Speaker 00:
Thank you, Your Honors.

[00:24:23] Speaker 00:
Just following up quickly on one thing opposing counsel just said, that LDX didn't exist.

[00:24:29] Speaker 00:
And that was clear error for the

[00:24:31] Speaker 00:
district court to conclude just because it didn't exist that there's no motivation or reasonable expectation, especially when the Patrick reference both defines the problem and provides the solution.

[00:24:42] Speaker 00:
You know, counsel, you know.

[00:24:44] Speaker 01:
Okay, I'm just going to kind of take over now for a sec.

[00:24:46] Speaker 01:
I think the district court did a great job in this case.

[00:24:48] Speaker 01:
It was really difficult and I think that what was accomplished was impressive.

[00:24:53] Speaker 01:
And I don't think you can possibly win in reversing all five of these things.

[00:24:58] Speaker 01:
That being said, I think that you did a good job on a couple of them and they probably would warrant maybe vacating or remanding, but I don't know what the point is given that you have to win all five and this August 24th deadline is looming large.

[00:25:11] Speaker 01:
So what do you have to say to that?

[00:25:13] Speaker 01:
Assuming my hypothetical is the way I actually feel, what do I do?

[00:25:18] Speaker 00:
Obviously, respectfully disagree on us fulfilling all five, but I understand hypothetical.

[00:25:24] Speaker 00:
I mean, I think what counsel just said, counsel spent time talking about exceptional case, counsel did not- No, but didn't we just create sufficient record for you on that, that you can take back to this district court judge and put an end to that?

[00:25:35] Speaker 00:
I mean, I would hope so, Your Honor.

[00:25:37] Speaker 00:
I would hope that would be sufficient.

[00:25:39] Speaker 00:
I don't know what counsel is going to do with that and going to do with how this court disposes of the case.

[00:25:44] Speaker 00:
Obviously, that is concern.

[00:25:46] Speaker 00:
Obviously, what's also concern is just you have these legal conclusions and findings out there that are wrong that stand as good case law if this court doesn't

[00:25:57] Speaker 00:
address them, but I totally understand.

[00:25:59] Speaker 01:
How do they stand as good case law?

[00:26:00] Speaker 01:
Good case law for who?

[00:26:01] Speaker 01:
If I rule 36 this case, who is that case law for?

[00:26:04] Speaker 00:
It's still a district court persuasive authority.

[00:26:07] Speaker 01:
On expired patents?

[00:26:10] Speaker 00:
I'm sorry, just persuasive authority that might potentially someone might want to use in a future case.

[00:26:14] Speaker 00:
But I do take your point, Your Honor.

[00:26:17] Speaker 01:
OK, do you have a last thought?

[00:26:19] Speaker 00:
Just last thought, the district court, often where it went wrong, was departing from where parties positions that neither party advanced.

[00:26:26] Speaker 00:
And I think the reason is because the record doesn't support many of those positions, many of which we discussed already.

[00:26:32] Speaker 00:
Thank you for your time.

[00:26:33] Speaker 01:
I thank both counsel for the argument.

[00:26:34] Speaker 01:
The case is taken under submission.