[00:00:01] Speaker 04:
Our final case for argument today is 25-1162, Insight Corporation versus Sun Pharmaceutical.

[00:00:11] Speaker 03:
Good morning, Your Honor.

[00:00:13] Speaker 03:
May it please the court?

[00:00:14] Speaker 03:
Paul Torsha on behalf of Sun Pharmaceuticals.

[00:00:17] Speaker 03:
The district court preliminarily enjoined Sun from launching Lexelbe.

[00:00:21] Speaker 03:
Lexelbe is a branded new FDA approved alopecia medication.

[00:00:26] Speaker 03:
And critically, Sun is the only party that can make it.

[00:00:29] Speaker 03:
This is not a generic case.

[00:00:31] Speaker 03:
This is not a case where Insight has its own patented product on the market.

[00:00:36] Speaker 03:
Indeed, although Insight says it has a patented product that it is developing, it is undisputed that that patented product will not be ready to be launched, if ever, until years.

[00:00:48] Speaker 00:
Is this case proceeding?

[00:00:50] Speaker 00:
I mean, I know we had the preliminary injunction that was like six, four months ago, five months ago, six months ago.

[00:00:54] Speaker 00:
Is this, is there a trial date?

[00:00:56] Speaker 03:
Yeah, it's October, and that's a significant point.

[00:00:59] Speaker 03:
It's in October of 2026, two months before the patent expires.

[00:01:04] Speaker 00:
I mean, a year from this October is when the trial date is?

[00:01:07] Speaker 03:
Yes, that's right.

[00:01:09] Speaker 00:
So the preliminary injunction clearly is in place until, well, how long is it until the injunction itself doesn't have an end date?

[00:01:18] Speaker 00:
No.

[00:01:18] Speaker 00:
Presumably it's what?

[00:01:21] Speaker 03:
It's going to be in place until the Vatnik's bias, until there is a trial in the merits in late 2026.

[00:01:27] Speaker 03:
And so this is a case, again, where Insight doesn't have its own patented product on the market.

[00:01:35] Speaker 03:
It's undisputed that they will not have their patented product on the market, if at all, ever until years after the patent expires.

[00:01:42] Speaker 03:
And that's critical to two issues that we're going to address today.

[00:01:45] Speaker 03:
First, irreparable harm.

[00:01:47] Speaker 03:
And also, it's relevant to written description, too.

[00:01:49] Speaker 03:
So before we get into those issues, I think it's important to focus on what Insight has said.

[00:01:54] Speaker 03:
What they are urging the court to do is to simply defer to the trial judge on the abuse of discretion standard.

[00:02:02] Speaker 03:
It's the entire thrust of their brief that this court should not look into the merits and simply defer.

[00:02:07] Speaker 03:
But this is a preliminary injunction.

[00:02:10] Speaker 03:
It's an extraordinary remedy, and this court

[00:02:14] Speaker 03:
reviews, preliminary injunction orders with rigor, especially on irreparable harm.

[00:02:20] Speaker 00:
But it's not quite everything they said, because they also say in the alternative, forget about deference.

[00:02:28] Speaker 00:
And if you don't go with us on this one issue, you ought to flip the judge on the other issue.

[00:02:34] Speaker 03:
They do.

[00:02:34] Speaker 03:
They say that.

[00:02:35] Speaker 03:
They say that the district court got it wrong when it found that a pure stream of licensing revenue would be compensable by money damages.

[00:02:45] Speaker 03:
No court has ever reversed a district court on that basis.

[00:02:48] Speaker 03:
It is straight up compensable money damage.

[00:02:51] Speaker 03:
So their alternative grounds for relief

[00:02:53] Speaker 03:
is baseless.

[00:02:54] Speaker 00:
Can I ask you, the district court labeled one through five, the reasons.

[00:02:58] Speaker 00:
Were there really five separate reasons presented why there's irreparable harm?

[00:03:03] Speaker 00:
And this was number five, the one she ultimately settled on?

[00:03:07] Speaker 03:
Yes.

[00:03:08] Speaker 03:
So yeah, this was one.

[00:03:09] Speaker 03:
The fifth reason in their briefing was the last one.

[00:03:12] Speaker 03:
It was called the Head Start Theory.

[00:03:14] Speaker 03:
It was their last irreparable harm theory.

[00:03:15] Speaker 03:
They devoted about a page in their brief to it.

[00:03:18] Speaker 03:
And the theory was based on the proposition.

[00:03:21] Speaker 03:
that Litzelvy, Sun's launch of Litzelvy today, is going to do irreparable harm to an insight product that does not exist today and will not exist until years after the patent expired.

[00:03:33] Speaker 03:
Indeed, this is a pre-phase one.

[00:03:36] Speaker 04:
So, yeah, it's a super compelling argument.

[00:03:39] Speaker 04:
So don't take this as a hostile question, but it's a hostile question.

[00:03:43] Speaker 04:
You seem to be arguing for a line in the sand

[00:03:47] Speaker 04:
If they don't have a product that is, in fact, FDA approved, they shouldn't be able to get a preliminary injunction.

[00:03:55] Speaker 04:
I'm really struggling with that.

[00:03:57] Speaker 04:
Is that really what you're asking for?

[00:03:58] Speaker 04:
Because you're seeing very reasonable podium, and I like everything you're saying.

[00:04:02] Speaker 04:
But I felt like your brief took a much more severe approach to what you thought we ought to make the law say.

[00:04:07] Speaker 03:
You don't need to make that decision.

[00:04:09] Speaker 03:
You don't need to say that there is no situation ever where you could have an unapproved product and have a PI based on it.

[00:04:15] Speaker 03:
We are not there.

[00:04:16] Speaker 03:
We are pre-phase one in an NDA.

[00:04:19] Speaker 04:
Didn't you kind of argue it in your brief, though?

[00:04:21] Speaker 04:
Well, yes, in your... Okay.

[00:04:23] Speaker 04:
All right.

[00:04:23] Speaker 04:
Just make sure I'm not crazy.

[00:04:25] Speaker 04:
Well, you're not.

[00:04:25] Speaker 04:
So you swung for the fences in the brief, but you're saying you'll take a base hit.

[00:04:29] Speaker 03:
Well, I mean, it's true.

[00:04:31] Speaker 03:
It is true that there's no case that even grants this kind of remedy in a generic that has tentative approval that is about to be launched.

[00:04:38] Speaker 04:
In other words, that isn't this case, but it is in fact... Yeah, but there's no case that denied it under those circumstances.

[00:04:43] Speaker 03:
Yes, that's true.

[00:04:45] Speaker 04:
Come on.

[00:04:46] Speaker 04:
The incentives can't possibly be that if you don't have FDA approval, they can't get it.

[00:04:53] Speaker 04:
What if they've got 20 years, in 19 years, left in 364 days in their patent term, and they're, by all accounts, passed stage three trials, they're on the eve of FDA approval, and you're going to launch some generic, it comes out at seven cents a pill, and undermine the brand's ability to come on at Monopoly pricing.

[00:05:12] Speaker 04:
I mean, clearly, we cannot have a rule.

[00:05:14] Speaker 04:
That would say, sorry, Charlie, no head start matters in that case, no.

[00:05:19] Speaker 03:
The court does not need to enter such a rule.

[00:05:20] Speaker 04:
You asked me to enter that rule.

[00:05:22] Speaker 04:
You asked for that rule, and I'm just pointing out that that was a bad ask.

[00:05:29] Speaker 03:
So the thrust of our brief is that on this record, there can't be a record behind.

[00:05:36] Speaker 04:
I know, and I agree with you.

[00:05:37] Speaker 04:
You won.

[00:05:38] Speaker 04:
What else you got?

[00:05:39] Speaker 01:
Can I ask you if we agree with you on irreparable harm and that they lose and the injunction can't be based on that.

[00:05:49] Speaker 01:
Do we.

[00:05:50] Speaker 01:
But we disagree with you on the written description stuff.

[00:05:53] Speaker 01:
I think the district court got that right.

[00:05:56] Speaker 01:
What do we do.

[00:05:57] Speaker 01:
Can we just reverse the injunction because irreparable harm is so critical?

[00:06:02] Speaker 01:
Or do we have to send it back for the district court to look at the four factors again?

[00:06:07] Speaker 03:
No.

[00:06:07] Speaker 03:
I mean, there's many cases that say that irreparable harm alone is enough.

[00:06:12] Speaker 03:
And you can simply reverse and remand.

[00:06:15] Speaker 00:
And this is an unusual case where the judge considered alternative things.

[00:06:19] Speaker 00:
She didn't just say, well, I don't have to consider their other irreparable harm theories because I'm going to settle on Head Start.

[00:06:25] Speaker 00:
She went through and rejected their other arguments with respect to irreparable harm.

[00:06:30] Speaker 03:
That's right.

[00:06:30] Speaker 03:
It's a he.

[00:06:31] Speaker 03:
Judging it as a he, but yes, that's true.

[00:06:34] Speaker 03:
And so we have a very small issue left on irreparable harm.

[00:06:36] Speaker 03:
We know that it's fatally deficient because it involves

[00:06:40] Speaker 03:
a product that's not just on proof, but it's pre-faced one.

[00:06:43] Speaker 03:
It's never been tested in humans.

[00:06:44] Speaker 03:
Not even close.

[00:06:45] Speaker 04:
Trust me, I know the facts.

[00:06:46] Speaker 04:
You don't have to beat me with them.

[00:06:47] Speaker 03:
I got them.

[00:06:48] Speaker 04:
I swear to God, I got your facts.

[00:06:50] Speaker 04:
You seem incredulous, but I'm actually with you, 100%.

[00:06:55] Speaker 03:
But to address, Judge Hughes, your point on written description,

[00:07:00] Speaker 03:
If the court doesn't agree with some written description, no, it doesn't need to remand for further proceedings.

[00:07:03] Speaker 01:
The lack of showing unreparable harm is more than sufficient to- Do we even have to address your arguments on written description if we agree with you on irreparable harm?

[00:07:12] Speaker 03:
So not to be cute, but if you like our argument on- No, no, no, no.

[00:07:17] Speaker 01:
I don't want to hear that you want us to address it because it might give you ammunition in the underlying litigation, because I'm not going to do that.

[00:07:23] Speaker 01:
The district court judge can make the determination on that, and we can review that later.

[00:07:28] Speaker 04:
Oh, and you wouldn't likely have me on that.

[00:07:30] Speaker 04:
So you probably want to steer clear of that one.

[00:07:31] Speaker 03:
Yeah.

[00:07:32] Speaker 03:
So I think we want to steer clear of that point, Roger.

[00:07:34] Speaker 03:
I think that the point on irreparable harm is sufficient for a reversal and remand of this preliminary injunction.

[00:07:42] Speaker 03:
It's unprecedented.

[00:07:43] Speaker 03:
And it is clearly speculated.

[00:07:48] Speaker 03:
The other side has made some arguments that, apart from the launch, that the district court decided that there was an investment value, thought that was worth addressing.

[00:07:57] Speaker 03:
That actually wasn't a finding.

[00:07:58] Speaker 03:
There was no independent finding of harm to investment.

[00:08:01] Speaker 03:
No federal circuit court has ever found that an independent harm to investment, even if the court did make that finding, would be sufficient for irreparable harm.

[00:08:10] Speaker 03:
So yes, on that basis,

[00:08:12] Speaker 03:
There should be a reversal and remand on the issue of reprehensible harm.

[00:08:16] Speaker 03:
And as your honor says, there's no need for this court to address the 112 issues.

[00:08:21] Speaker 03:
In that opinion, you can just reverse on that basis.

[00:08:25] Speaker 04:
I can save the rest of the time for rebuttal.

[00:08:28] Speaker 04:
Good plan.

[00:08:32] Speaker 04:
Mr. Feldstein?

[00:08:35] Speaker 04:
You want your iPad?

[00:08:37] Speaker 04:
Oh.

[00:08:37] Speaker 02:
Thank you, sir.

[00:08:42] Speaker 02:
There's the court.

[00:08:43] Speaker 02:
Mark Felt sitting on behalf of Appellee Insight.

[00:08:46] Speaker 02:
I'd like to address the comment made by counsel just now that there was no separate finding of reprehensible harm due to effect on investment value.

[00:08:56] Speaker 02:
In fact, the finding was made twice and was ignored by some largely in their briefs for the finding on page

[00:09:02] Speaker 02:
Appendix page 43, if there was an investment harm, there's a finding on page 49 from the balance of the hardships that reinforces that irreparable harm.

[00:09:12] Speaker 02:
But the judge found on page 43 is, Sun's premature entrance into the AA market diminishes the value of plaintiff's investments in topical AA product.

[00:09:24] Speaker 02:
What the court then again found on appendix page 49 is that

[00:09:33] Speaker 02:
Additionally, Insight would lose substantial investment, continued investment, in developing a treatment setting the same underlying evidence.

[00:09:40] Speaker 02:
That's under the public interest problem.

[00:09:41] Speaker 02:
That's correct, Your Honor.

[00:09:42] Speaker 02:
And it's citing back to the same evidence that the court cited too.

[00:09:46] Speaker 02:
Here's my problem with all that.

[00:09:47] Speaker 04:
My problem with all that is it all hinges on the primary factual inaccuracy that this district court judge made on page 41, which really tracks so clearly with what your opposing counsel said.

[00:10:00] Speaker 04:
I want you to go to page 41 of the district court's opinion.

[00:10:03] Speaker 04:
And on this page, it says, the nexus is straightforward, but for sons, and I'm going to try really hard never to say anything confidential.

[00:10:13] Speaker 04:
So if I start to, just like wave your hands or stop me or something.

[00:10:16] Speaker 04:
But it says, but for sons, I don't know how to pronounce the product, in size 355 patent will provide it with the ability to bring a duro-ruxolibinib AA treatment first to market.

[00:10:33] Speaker 04:
false.

[00:10:34] Speaker 04:
That is clearly erroneous.

[00:10:35] Speaker 04:
That is clearly erroneous because every document that you provided in this case demonstrates that you can't be on the market.

[00:10:42] Speaker 04:
You're not even going to seek FDA approval until years after your patent expires.

[00:10:45] Speaker 04:
They can flood the market, be on the market for years.

[00:10:48] Speaker 04:
So this fact finding is clearly erroneous.

[00:10:51] Speaker 04:
There's nothing in this record that supports it.

[00:10:53] Speaker 04:
And so everything she found thereafter, including the hit you're going to take in terms of investments in your product, was all premised on this

[00:11:02] Speaker 04:
fundamentally inaccurate fact-finding.

[00:11:05] Speaker 02:
I would respectfully disagree, Your Honor.

[00:11:08] Speaker 02:
The finding, the way we read the finding in context is the court understood that during the lifetime of the 335 patent, Insight could protect it because elsewhere the court found it may take me a second to find it.

[00:11:20] Speaker 04:
Elsewhere the court recognized... She says you would be first to market.

[00:11:23] Speaker 04:
First to market.

[00:11:25] Speaker 04:
That is inaccurate.

[00:11:27] Speaker 04:
by your own documents.

[00:11:29] Speaker 02:
The court elsewhere recognized expressly that there's a time where we would be coming to market later.

[00:11:35] Speaker 02:
And the court's opinion is not premised on insight coming to market first.

[00:11:42] Speaker 02:
That one statement you raised, I recognize what it says.

[00:11:46] Speaker 02:
And the problem is that, as the court found earlier,

[00:11:52] Speaker 02:
that what you're giving Sun, you're giving an advance head start of two years onto the market to entrench yourself.

[00:11:57] Speaker 02:
And that's something that Sun embraces as their business strategy, their entire business strategy.

[00:12:02] Speaker 02:
And this is, again, what they ignore in their briefing.

[00:12:05] Speaker 02:
they ignore their own undisputed business strategy.

[00:12:08] Speaker 04:
I think the head start thing is an economically sound principle in a circumstance where you would actually be able to enter the market prior to the patents expiration and therefore be first.

[00:12:21] Speaker 04:
And I think with this product, you've got such a lot of stuff in this record that

[00:12:25] Speaker 04:
really convincingly establishes like a brand devotion or loyalty.

[00:12:28] Speaker 04:
You know, somebody starts using a product, whoever's it is, they're not going to switch.

[00:12:32] Speaker 04:
I get it.

[00:12:32] Speaker 04:
If I was somebody who had air loss and I start using a product and the label says, if you stop using this product or your hair's going to fall out, I would not stop using that product ever.

[00:12:40] Speaker 04:
The rest of my life I keep using that product.

[00:12:42] Speaker 04:
And I understand why people would do that.

[00:12:44] Speaker 04:
So I get your head start theory, no pun intended.

[00:12:47] Speaker 04:
I get the head start theory, the economic principles behind it.

[00:12:49] Speaker 04:
But the problem is it doesn't apply here

[00:12:51] Speaker 04:
because they're going to, by virtue of your own documents, be able to launch years before you will be in market once your patent expires.

[00:12:59] Speaker 04:
So they're going to get that head start no matter what.

[00:13:01] Speaker 04:
Wait.

[00:13:02] Speaker 04:
I know it's long.

[00:13:02] Speaker 04:
I swear I'll give you all the time you want.

[00:13:04] Speaker 04:
What you needed to prove was there was some difference between the number of years if they launch now and the number of years they would launch, accepting as true your own representations about when you will seek FDA approval, and that there's some serious economic difference there.

[00:13:18] Speaker 04:
You didn't even attempt to do that.

[00:13:20] Speaker 04:
this cursory in a paragraph Head Start concept, a concept I agree with but doesn't seem to apply here and you haven't backed it up.

[00:13:26] Speaker 02:
So Sun in fact makes that case for us the early two years

[00:13:30] Speaker 02:
are substantial and but they're going to get the early two years no matter what your product by your own documents won't be anywhere near market when your patent expires they're going to get their two years they're getting an additional two years so if you're in a race with somebody and they get a 20 minute head start versus a 40 minute head start it's a difference on how far behind you are how far you have to catch up

[00:13:53] Speaker 02:
They're getting the extra 20 minutes to construct.

[00:13:56] Speaker 00:
That's not just a market concept that we accept as a given.

[00:14:00] Speaker 00:
No, it depends.

[00:14:01] Speaker 00:
You didn't make that case.

[00:14:02] Speaker 00:
But there's no case made that if they have four years head start rather than two years, you're going to be irreparably harmed by that.

[00:14:14] Speaker 00:
You've got to make it in a pretty non-speculative way.

[00:14:16] Speaker 00:
And there's an assumption.

[00:14:20] Speaker 00:
I guess that that's likely to be the case, but I don't get that they're there.

[00:14:26] Speaker 02:
There's underlying evidence that the early head start adds additional time that is going to make it harder for us to catch up.

[00:14:34] Speaker 02:
Some of this, as I said, comes from Sun directly.

[00:14:36] Speaker 02:
Their Nelson Declaration, which is Appendix 9949,

[00:14:40] Speaker 02:
they go into detail about how these early two years are critical to the business justification for going forward.

[00:14:46] Speaker 02:
It affects the business value of the investment.

[00:14:49] Speaker 02:
It affects the business value of the product.

[00:14:51] Speaker 00:
In reply, the chief said they're getting the early two years.

[00:14:55] Speaker 00:
We're talking now about whether we add more years to the initial head start that they will get in any event.

[00:15:03] Speaker 02:
Is the time period now the market is growing as a nascent market as the court found and that it's not disputed by the other side is growing market blocking in these patients during this early phase will block them potentially from insight ever getting them.

[00:15:18] Speaker 02:
And so yes, the 335 patent expires before our product is expected to make it to the market, but by Sun having a 40-minute head start instead of a 20-minute head start, they're locking in additional customers during the early time period.

[00:15:34] Speaker 02:
What they say in pages 14 to 15 is they recognize this very fact that the market dynamics can underlie the very business justification for

[00:15:45] Speaker 02:
bringing a product to market.

[00:15:46] Speaker 02:
And so if they continue to flood the market for an additional two years, that undermines the business justification.

[00:15:53] Speaker 02:
It goes to the value of the investment, which the court found as a separate finding in appendix 43.

[00:16:01] Speaker 02:
And then, as I said, reiterated it at 49.

[00:16:04] Speaker 02:
And it goes to the long-term harm to when Insight's product comes to the market.

[00:16:08] Speaker 02:
It's a newly lost market share, potentially, to Sun's product.

[00:16:13] Speaker 04:
I have a factual question for you.

[00:16:16] Speaker 04:
You have two different appendices, charts, tables, timelines.

[00:16:21] Speaker 04:
And they're slightly different.

[00:16:23] Speaker 04:
And I don't know, is one of them an updated one?

[00:16:27] Speaker 04:
And I'm going to point you in particular, because I just want to make sure we work with the correct numbers.

[00:16:33] Speaker 04:
So you have a timeline at page JA10575.

[00:16:45] Speaker 04:
And then you have almost the identical timeline at 1-0-5-8-8.

[00:16:53] Speaker 04:
And I guess I want to know which of these timelines is the more relevant one for purposes of when you are likely to seek FDA approval and obtain FDA approval.

[00:17:06] Speaker 02:
The NDA submission is the same quarter in both.

[00:17:13] Speaker 04:
No, no, actually it's about two years apart.

[00:17:16] Speaker 04:
Look on 10580.

[00:17:18] Speaker 02:
I apologize.

[00:17:20] Speaker 02:
The 110 575 is the correct timeline to be looking at then.

[00:17:26] Speaker 04:
Why would I know that?

[00:17:27] Speaker 04:
Why are these both in this record then?

[00:17:29] Speaker 04:
These are both produced by your client.

[00:17:31] Speaker 04:
One of them has the FDA pursuit years after the other.

[00:17:36] Speaker 04:
Which one am I supposed to rely on?

[00:17:39] Speaker 04:
Which one's later in time?

[00:17:40] Speaker 04:
Give me something in the record, other than just your assertion here at the council table.

[00:17:44] Speaker 02:
I'll have to find it.

[00:17:44] Speaker 02:
I don't think there was a dispute that the date that is shown on appendix 10-575 is the date that the witness, as Dr. Flannery testified to, his declaration as to when the NDA would be submitted.

[00:18:00] Speaker 04:
And just out of curiosity, what's 10588?

[00:18:04] Speaker 04:
Is this maybe, do you think this is an earlier timeline or something?

[00:18:10] Speaker 04:
I'm just trying to understand the difference because I'll tell you the one at 10588 has more specificity in it.

[00:18:17] Speaker 04:
Like if you look under the portion of the timeline around the 25, 26 time period, they've got some details that aren't present in this 105751.

[00:18:29] Speaker 04:
The 10588 has more information in more detailed fashion

[00:18:34] Speaker 04:
And I tended to think when I looked at the two, it was the later in time and therefore more likely to be correct one.

[00:18:41] Speaker 04:
But I'd like to know from you if that's true.

[00:18:43] Speaker 02:
Yeah, I don't have an answer for you right now on 10588.

[00:18:46] Speaker 02:
I am confident that the timeline on the NDA submission on 10-575 is what Dr. Flannery testified to in declaration as the- And where it says ND, that's NDA and the A is just blacked out, right?

[00:19:02] Speaker 02:
Correct.

[00:19:04] Speaker 02:
OK.

[00:19:07] Speaker 02:
So again, the harm to the investment is an independent harm that happens now.

[00:19:13] Speaker 02:
It's an immediate harm that the court found that Sun's response to is to ignore and pretend it didn't happen.

[00:19:21] Speaker 02:
It's a separate finding.

[00:19:22] Speaker 02:
There are two findings for the verbal harm.

[00:19:24] Speaker 02:
One is to the immediate investment value.

[00:19:27] Speaker 02:
One is to long-term market share.

[00:19:30] Speaker 02:
Both will be affected by Sun having extra time

[00:19:33] Speaker 02:
in the market to lock in customers.

[00:19:37] Speaker 02:
The illuminate point is an additional point.

[00:19:39] Speaker 02:
The illuminate is already on the market.

[00:19:42] Speaker 02:
And what Sun, again, confirms and helps us in their reply, they confirm that what the court did there was looked at the short-term damages period.

[00:19:51] Speaker 02:
And I think it's Appendix 36, where the court's opinion is on that.

[00:19:54] Speaker 02:
And the court was looking only through the expiration of the 335 patent for damages, a relatively short time in the scheme of things.

[00:20:04] Speaker 02:
A royalty source from Illumiant is from a different patent, is a different source.

[00:20:09] Speaker 02:
It continues.

[00:20:10] Speaker 02:
And the head start harm that the court found that will have long-term impact by sun locking in customers long-term equally affects the long-term harm to the Illumiant and the royalties from that, that the court didn't apply its own findings back.

[00:20:28] Speaker 02:
It cut off its harm at the idea of the 335 exploration, which

[00:20:34] Speaker 02:
was not right because, as we argued below, it was a long-term harm.

[00:20:37] Speaker 02:
And that long-term hit start harm affects allumiant equally.

[00:20:41] Speaker 02:
If the court found that it will affect allumiant pricing, for example, going forward, it will affect market share going forward.

[00:20:50] Speaker 04:
OK.

[00:20:50] Speaker 04:
Anything further?

[00:20:52] Speaker 04:
OK.

[00:20:52] Speaker 04:
Thank you, counsel.

[00:20:53] Speaker 04:
Thank you.

[00:21:01] Speaker 03:
I thought I'd start by addressing the investment point, which we alluded to earlier.

[00:21:06] Speaker 03:
There wasn't a separate finding of an investment.

[00:21:09] Speaker 03:
In fact, there wasn't even an articulation below about what their present investment was in this product.

[00:21:17] Speaker 03:
What they gave is a number, and you can see it on appendix.

[00:21:19] Speaker 03:
The district court recites it on appendix 43.

[00:21:22] Speaker 03:
It's a number of what their projected investment was.

[00:21:25] Speaker 03:
I can't say what it is here.

[00:21:26] Speaker 03:
It's not a large number.

[00:21:28] Speaker 03:
There was a much smaller number that is what their present investment was.

[00:21:32] Speaker 03:
That was actually alluded to in a parallel appeal involving this case.

[00:21:37] Speaker 04:
But all of those numbers are premised on the Head Start argument anyway, because that very paragraph begins with the word son's premature entrance into the AA market.

[00:21:46] Speaker 04:
And so if you're going to get a head start either way, one of those numbers matter.

[00:21:50] Speaker 03:
Correct.

[00:21:50] Speaker 04:
I mean, especially the kind of head start we're talking about.

[00:21:51] Speaker 04:
It's not a day.

[00:21:52] Speaker 04:
You know, it's not a week.

[00:21:54] Speaker 04:
It's a significant chunk of time.

[00:21:55] Speaker 03:
Yes.

[00:21:56] Speaker 04:
You ready to go to market?

[00:21:57] Speaker 03:
Yes.

[00:21:59] Speaker 03:
So, and yes, Your Honor, that the last thing... Like you're geared up and ready to go?

[00:22:03] Speaker 03:
Yes, Your Honor.

[00:22:05] Speaker 03:
And I guess the last issue I'd like to address is relates to the point about, yes, Sun believes that a reversal on this issue is the appropriate for that reason.

[00:22:14] Speaker 03:
Sun is eager to release this product to patients.

[00:22:17] Speaker 03:
And as Rona Judge-Steve Hughes has noted, the only issue that needs to be addressed is ripple bar.

[00:22:24] Speaker 04:
I don't have anything to add.

[00:22:25] Speaker 04:
Excellent.

[00:22:25] Speaker 04:
Thank all counsel, case taken under submission.